,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32491907,Randomized multifractal detrended fluctuation analysis of long time series.,"A novel general randomized method is proposed to investigate multifractal properties of long time series. Based on multifractal temporally weighted detrended fluctuation analysis (MFTWDFA), we obtain randomized multifractal temporally weighted detrended fluctuation analysis (RMFTWDFA). The innovation of this algorithm is applying a random idea in the process of dividing multiple intervals to find the local trend. To test the performance of the RMFTWDFA algorithm, we apply it, together with the MFTWDFA, to the artificially generated time series and real genomic sequences. For three types of artificially generated time series, consistency tests are performed on the estimated h(q), and all results indicate that there is no significant difference in the estimated h(q) of the two methods. Meanwhile, for different sequence lengths, the running time of RMFTWDFA is reduced by over ten times. We use prokaryote genomic sequences with large scales as real examples, the results obtained by RMFTWDFA demonstrate that these genomic sequences show fractal characteristics, and we leverage estimated exponents to study phylogenetic relationships between species. The final clustering results are consistent with real relationships. All the results reflect that RMFTWDFA is significantly effective and timesaving for long time series, while obtaining an accuracy statistically comparable to other methods.",2020,"To test the performance of the RMFTWDFA algorithm, we apply it, together with the MFTWDFA, to the artificially generated time series and real genomic sequences.",[],['RMFTWDFA'],[],[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],,0.0302263,"To test the performance of the RMFTWDFA algorithm, we apply it, together with the MFTWDFA, to the artificially generated time series and real genomic sequences.","[{'ForeName': 'Fang-Xin', 'Initials': 'FX', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Intelligent Computing and Information Processing of Ministry of Education and Hunan Key Laboratory for Computation and Simulation in Science and Engineering, Xiangtan University, Xiangtan, Hunan 411105, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Intelligent Computing and Information Processing of Ministry of Education and Hunan Key Laboratory for Computation and Simulation in Science and Engineering, Xiangtan University, Xiangtan, Hunan 411105, China.'}, {'ForeName': 'Guo-Sheng', 'Initials': 'GS', 'LastName': 'Han', 'Affiliation': 'Key Laboratory of Intelligent Computing and Information Processing of Ministry of Education and Hunan Key Laboratory for Computation and Simulation in Science and Engineering, Xiangtan University, Xiangtan, Hunan 411105, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Intelligent Computing and Information Processing of Ministry of Education and Hunan Key Laboratory for Computation and Simulation in Science and Engineering, Xiangtan University, Xiangtan, Hunan 411105, China.'}, {'ForeName': 'Zu-Guo', 'Initials': 'ZG', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Intelligent Computing and Information Processing of Ministry of Education and Hunan Key Laboratory for Computation and Simulation in Science and Engineering, Xiangtan University, Xiangtan, Hunan 411105, China.'}]","Chaos (Woodbury, N.Y.)",['10.1063/1.5139620']
1,32343107,Implementation of an Evidence-Based Guideline of Enteral Nutrition for Infants With Congenital Heart Disease: A Controlled Before-and-After Study.,"OBJECTIVES
To describe the implementation process of a nutrition risk screening and assessment guideline for infants with congenital heart disease and to assess the impact of nurses' behavior and the effect on infants' outcomes.
DESIGN
A controlled before-and-after implementation study. The three dimensions of the integrated-Promoting Action on Research Implementation in Health Services framework were used to assess barriers and promoting factors.
SETTING
Cardiac center at Children's Hospital of Fudan University, Shanghai, China.
PATIENTS
Infants with congenital heart disease (n = 142) and nurses (n = 100).
INTERVENTIONS
Implementation of an evidenced-based nutrition risk screening and assessment guideline.
MEASUREMENTS AND MAIN RESULTS
Implementation processes were assessed on nurses' knowledge, attitude, behavior, and compliance of the guideline. Infants' clinical outcomes were evaluated before-and-after the implementation. Knowledge, attitude, and behavior of nurses about nutrition risk screening and assessment increased significantly after implementing the guideline. Nurses' compliance with the recommendations for nutritional risk screening improved significantly on three criteria; assessment of nutritional status stability (p < 0.001), assessment of nutritional status deterioration (p = 0.003), and nutritional assessment among infants with moderate risk and above (p < 0.001). The nurses' compliance with the recommendations for nutrition assessment improved significantly in eight of the 10 criteria (p < 0.001). The proportion of infants receiving comprehensive nutrition assessment when they were first screened with moderate or high nutritional risk were higher in the intervention group (24.3% vs 83.3%; p < 0.001). The accuracy rates of nutrition risk screening were higher in the intervention group (52.9% vs 81.9%; p < 0.001).
CONCLUSIONS
Using the integrated-Promoting Action on Research Implementation in Health Services framework contributed to a successful implementation of the nutrition guideline. The nurses' knowledge, attitude, and behavior toward the nutrition guideline were positive resulting in a significantly higher nutrition assessments in infants with moderate or high nutritional risk.",2020,"The accuracy rates of nutrition risk screening were higher in the intervention group (52.9% vs 81.9%; p < 0.001).
","['Infants with congenital heart disease (n = 142) and nurses (n = 100', ""Cardiac center at Children's Hospital of Fudan University, Shanghai, China"", 'infants with congenital heart disease', 'infants with moderate or high nutritional risk', 'Infants With Congenital Heart Disease']","['Implementation of an evidenced-based nutrition risk screening and assessment guideline', 'nutrition risk screening and assessment guideline', 'Enteral Nutrition']","['proportion of infants receiving comprehensive nutrition assessment', ""nurses' knowledge, attitude, behavior, and compliance of the guideline"", 'nutritional status stability', 'moderate or high nutritional risk', 'nutritional status deterioration', 'accuracy rates of nutrition risk screening']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0028708', 'cui_str': 'Assessment of nutritional status'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",142.0,0.0233883,"The accuracy rates of nutrition risk screening were higher in the intervention group (52.9% vs 81.9%; p < 0.001).
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': ""Nursing Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""School of Nursing, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Shanghai University of Medicine & Health Science, Shanghai, People's Republic of China.""}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': ""Cardiac Intensive Care Unit, Children's Hospital of Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Cardiovascular Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jos M', 'Initials': 'JM', 'LastName': 'Latour', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Health and Human Sciences, University of Plymouth, Plymouth, United Kingdom.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002296']
2,32343483,Motivational interviewing to improve self-care in heart failure patients (MOTIVATE-HF): a randomized controlled trial.,"AIMS
Self-care, an essential component of heart failure (HF) treatment, is inadequate in most patients. We evaluated if motivational interviewing (MI) (i) improves patient self-care maintenance (primary endpoint; e.g. taking medications), self-care management (e.g. responding to symptoms) and self-care confidence (or self-efficacy) 3 months after enrolment; (ii) changes self-care over 1 year, and (iii) augments patient self-care if informal caregivers are involved.
METHODS AND RESULTS
Parallel randomized controlled trial (1:1:1). A sample of 510 patients (median 74 years, 58% male) and caregivers (median 55 years, 75% female) was randomized to Arm 1 (MI only for patients), Arm 2 (MI for patients and caregivers), or Arm 3 (usual care). The intervention in Arms 1 and 2 consisted of one face-to-face MI session with three telephone contacts. Self-care was evaluated with the Self-Care of HF Index measuring self-care maintenance, management, and confidence. Scores on each scale range from 0 to 100 with higher scores indicating better self-care; ≥70 is considered adequate. At 3 months, self-care maintenance improved 6.99, 7.42 and 2.58 points in Arms 1, 2, and 3, respectively (P = 0.028). Self-care maintenance was adequate in 18.4%, 19.4%, and 9.2% of patients in Arms 1, 2 and 3, respectively (P = 0.016). Over 1 year, self-care maintenance, management, and confidence scores in Arms 1 and 2 were significantly higher than in Arm 3 in several follow-ups. Over 1 year, Arm 2 had the best scores in self-care management.
CONCLUSIONS
MI significantly improved self-care in HF patients. Including caregivers may potentiate the effect, especially in self-care management. ClinicalTrial.gov, identifier: NCT02894502.",2020,"At 3 months, self-care maintenance improved 6.99, 7.42 and 2.58 points in Arms 1, 2, and 3, respectively (P = 0.028).","['heart failure patients', '510 patients (median 74\xa0years, 58% male) and caregivers (median 55\xa0years, 75% female', 'HF patients']","['Motivational interviewing', 'motivational interviewing (MI) (i) improves patient self-care maintenance (primary endpoint; e.g. taking medications), self-care management']","['self-care maintenance', 'self-care', 'Self-care maintenance']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",510.0,0.064938,"At 3 months, self-care maintenance improved 6.99, 7.42 and 2.58 points in Arms 1, 2, and 3, respectively (P = 0.028).","[{'ForeName': 'Ercole', 'Initials': 'E', 'LastName': 'Vellone', 'Affiliation': 'Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rebora', 'Affiliation': 'Centre of Biostatistics for Clinical Epidemiology, Department of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Ausili', 'Affiliation': 'Centre of Biostatistics for Clinical Epidemiology, Department of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zeffiro', 'Affiliation': 'Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pucciarelli', 'Affiliation': 'Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Caggianelli', 'Affiliation': 'Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Masci', 'Affiliation': 'School of Counselling, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Alvaro', 'Affiliation': 'Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}]",ESC heart failure,['10.1002/ehf2.12733']
3,32339032,SAFETY AND EFFICACY OF DDP4-INHIBITORS FOR MANAGEMENT OF HOSPITALIZED GENERAL MEDICINE AND SURGERY PATIENTS WITH TYPE 2 DIABETES.,"Background: DPP4-inhibitors (DPP4-i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from three prospective studies using DPP4-i in general medicine and surgery patients with type 2 diabetes (T2D). Research Design and Methods: We combined data from three randomized studies comparing DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen. Medicine (n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with diet, oral agents or low-dose insulin therapy were included. Patients received DPP4-i alone (n=144), DPP4-i plus basal insulin (n=158) or basal bolus regimen (n=283). All groups received correctional doses with rapid-acting insulin for BG >140mg/dl. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications. Results: There were no differences in mean hospital daily BG among patients treated with DPP4-i alone (170±37 mg/dl), DPP4-i plus basal (172±42 mg/dl) or basal bolus (172±43 mg/dl), p=0.94; or in the percentage of BG readings within target of 70-180 mg/dl (63±32%, 60±31% and 64±28% respectively, p=0.42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP4-i alone (2%) compared to DPP4-i plus basal (9%) and basal bolus (10%), p=0.004. Conclusion: Treatment with DPP4-i alone or in combination with basal insulin is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin re gimen in general medicine and surgery patients with T2D.",2020,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"['general medicine and surgery patients with T2D', 'general medicine and surgery patients with type 2 diabetes (T2D', 'n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with']","['DPP4-i alone', 'correctional doses with rapid-acting insulin for BG >140mg/dl', 'DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen', ': DPP4-inhibitors (DPP4-i', 'diet, oral agents or low-dose insulin therapy', 'DPP4-i plus basal insulin (n=158) or basal bolus regimen', 'DPP4-i', 'DPP4-i alone or in combination with basal insulin', 'Medicine']","['hypoglycemia and hospital complications', 'mean daily BG', 'mean hospital daily BG', 'length of stay or complications, but hypoglycemia', 'hypoglycemia']","[{'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0952002,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lorenzo-González', 'Affiliation': 'From: Department of Endocrinology and Nutrition, Hospital Universitario Nuestra Señora de La Candelaria, Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Atienza-Sánchez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Príncipe de Asturias, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes-Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Schoolf of Public Health, Emory University.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0481']
4,32339664,"Effect of prefrontal tDCS on resting brain fMRI graph measures in Alcohol Use Disorders: A randomized, double-blind, sham-controlled study.","OBJECTIVES
Transcranial Direct Current Stimulation (tDCS) is a promising new adjuvant approach in the treatment of Alcohol Use Disorders (AUDs) that has the potential to ameliorate the aberrations secondary to chronic alcohol use. In this study, using a randomized, double-blind, sham-controlled, parallel-arm design, we examined the effects of prefrontal tDCS on resting-state functional magnetic resonance imaging (rsfMRI) and its correlates with impulsivity and time to first lapse in subjects with AUDs.
METHODS
Patients with AUD as per DSM-5 criteria were randomly allocated to receive a five-day course of either verum-tDCS (n = 12) or sham-tDCS (n = 12). Of them, 21 patients (verum/sham = 11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions. Outside the scanner, subjects also performed the Stop-Signal Task at two time-points (baseline and post-intervention), which provided a measure of changes in impulsivity following tDCS. After completion of the post-intervention scan, all subjects were discharged and were followed-up for 90 days post-discharge or until lapse to first alcohol use.
RESULTS
Graph theoretical analysis of rsfMRI data revealed that verum-tDCS (but not sham) resulted in a significant increase in the global efficiency of brain networks with a concurrent significant reduction in global clustering; network-based statistical analysis identified a significant increase in the functional connectivity of a specific sub-network involving prefrontal regions. Furthermore, increased global efficiency of brain networks following verum tDCS predicted a significantly reduced likelihood of relapse. In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
CONCLUSIONS
The present study adds further support to the increasing evidence base for the clinical utility of tDCS in AUDs. Importantly, we observed improvement in both whole-brain network efficiency as well as inter-regional connectivity within a specific local prefrontal sub-network that is relevant to the neurobiology of AUDs. Replication and extension of these promising leads from the present study can facilitate clinical translation of tDCS, given its advantages (i.e. safety, cost-effectiveness, administration ease with potential for remotely-supervised / home-based application) for treating patients with AUDs.",2020,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","['subjects with AUDs', 'Patients with AUD as per DSM-5 criteria', 'Alcohol Use Disorders', '21 patients (verum/sham\u202f=\u202f11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions']","['prefrontal tDCS', 'Transcranial Direct Current Stimulation (tDCS', 'verum-tDCS (n\u202f=\u202f12) or sham-tDCS']","['resting brain fMRI graph measures', 'likelihood of relapse', 'global efficiency of brain networks', 'functional connectivity of a specific sub-network involving prefrontal regions']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.15234,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","[{'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Holla', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Jitendriya', 'Initials': 'J', 'LastName': 'Biswal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Ramesh', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Venkataram', 'Initials': 'V', 'LastName': 'Shivakumar', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Rose Dawn', 'Initials': 'RD', 'LastName': 'Bharath', 'Affiliation': 'Neuroimaging and Interventional Radiology, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Benegal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India. Electronic address: gvs@nimhans.ac.in.'}, {'ForeName': 'Prabhat Kumar', 'Initials': 'PK', 'LastName': 'Chand', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109950']
5,32339648,Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma.,"BACKGROUND
The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis.
PATIENTS AND METHODS
Treatment-naive patients with aRCC were randomized (1 : 1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were PFS and overall survival (OS) among patients with programmed death ligand 1-positive (PD-L1+) tumors. Key secondary end points were OS and PFS in the overall population.
RESULTS
Of 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cut-off 28 January 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm {PD-L1+ population: hazard ratio (HR) 0.62 [95% confidence interval (CI) 0.490-0.777]}; one-sided P < 0.0001; median 13.8 (95% CI 10.1-20.7) versus 7.0 months (95% CI 5.7-9.6); overall population: HR 0.69 (95% CI 0.574-0.825); one-sided P < 0.0001; median 13.3 (95% CI 11.1-15.3) versus 8.0 months (95% CI 6.7-9.8)]. OS data were immature [PD-L1+ population: HR 0.828 (95% CI 0.596-1.151); one-sided P = 0.1301; overall population: HR 0.796 (95% CI 0.616-1.027); one-sided P = 0.0392].
CONCLUSION
Among patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS versus sunitinib; OS data were still immature.
CLINICAL TRIAL NUMBER
NCT02684006.",2020,OS data were immature (PD-L1+ population: HR 0.828,"['886 patients', 'advanced renal cell carcinoma (aRCC', 'patients with advanced renal cell carcinoma', 'Treatment-naïve patients with aRCC']","['axitinib (5 mg) orally twice daily or sunitinib', 'avelumab plus axitinib versus sunitinib', 'avelumab', 'avelumab plus axitinib']","['progression-free survival (PFS', 'PFS', 'OS and PFS in the overall population', 'PFS and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.268726,OS data were immature (PD-L1+ population: HR 0.828,"[{'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, USA. Electronic address: toni_choueiri@dcfi.harvard.edu.""}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'B I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic, Cleveland, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Campbell', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Venugopal', 'Affiliation': 'University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kollmannsberger', 'Affiliation': 'British Columbia Cancer Agency, Vancouver Centre, Vancouver, Canada.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gravis-Mescam', 'Affiliation': 'Institut Paoli-Calmettes, Department of Medical Oncology, Aix-Marseille Université, Inserm, CNRS, CRCM, Marseille, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'M-O', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Jena University Hospital, Department of Urology, Jena, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Macquarie University, Sydney, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmidinger', 'Affiliation': 'Clinical Division of Oncology, Department of Medicine I Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'City of Hope National Medical Center, Duarte, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Pfizer, Cambridge, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mariani', 'Affiliation': 'Pfizer Italia SRL, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Krishnaswami', 'Affiliation': 'Pfizer, Groton, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cislo', 'Affiliation': 'Pfizer, New York, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chudnovsky', 'Affiliation': 'Pfizer, Cambridge, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fowst', 'Affiliation': 'Pfizer Italia SRL, Milan, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Pfizer, Groton, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': 'Pfizer Italia SRL, Milan, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.010']
6,32340075,Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,"OBJECTIVE
To compare electrodiathermy with helium thermal coagulation in laparoscopic treatment of mild-to-moderate endometriosis.
DESIGN
Parallel-group randomised controlled trial.
SETTING
A UK endometriosis centre.
POPULATION
Non-pregnant women aged 16-50 years with a clinical diagnosis of mild-to-moderate endometriosis.
METHODS
If mild or moderate endometriosis was confirmed at laparoscopy, women were randomised to laparoscopic treatment with electrodiathermy or helium thermal coagulator.
MAIN OUTCOME MEASURES
Cyclical pain and dyspareunia (rated on a 100-mm visual analogue scale, VAS), quality of life at baseline and at 6, 12 and 36 weeks following surgery, operative blood loss and surgical complications.
RESULTS
A total of 192 women were randomised. Of these, 155 (81%) completed the primary outcome point at 12 weeks. In an intention-to-treat analysis, VAS scores for cyclical pain were significantly lower in the electrodiathermy group compared with the helium group at 12 weeks (mean difference, 9.43 mm; 95% CI 0.46, 18.40 mm; P = 0.039) and across all time points (mean difference, 10.13 mm; 95% CI 3.48, 16.78 mm; P = 0.003). A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference, 11.66 mm; 95% CI 1.39, 21.93 mm; P = 0.026). These effects were smaller than the proposed minimum important difference of 18.00 mm, however. Differences in some aspects of quality of life favoured electrodiathermy. There was no significant difference in operative blood loss (fold-change with helium as reference, 1.43; 95% CI 0.96, 2.15; P = 0.081).
CONCLUSIONS
Although electrodiathermy was statistically superior to helium ablation in reducing cyclical pain and dyspareunia, these effects may be too small to be clinically significant.
TWEETABLE ABSTRACT
Helium coagulation is not superior to electrodiathermy in laparoscopic treatment of mild-to-moderate endometriosis.",2020,"A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference = 11.66mm; 95% CI 1.39, 21.93; p = 0.026).","['laparoscopic treatment of mild-to-moderate endometriosis', 'A UK endometriosis centre', '192 women were randomized', 'mild-to-moderate endometriosis', 'Non-pregnant women aged 16-50 with a clinical diagnosis of mild-to-moderate endometriosis']","['Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy', 'electrodiathermy', 'laparoscopic treatment with electrodiathermy or helium thermal coagulator']","['cyclical pain and dyspareunia', 'operative blood loss; surgical complications', 'Cyclical pain and dyspareunia (rated on 100mm visual analogue scales), and quality of life', 'dyspareunia', 'operative blood loss', 'VAS scores for cyclical pain']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",192.0,0.391918,"A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference = 11.66mm; 95% CI 1.39, 21.93; p = 0.026).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Misra', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'El-Gizawy', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': 'Research and Innovation, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jerreat', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Coia', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ritchie', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16279']
7,32340502,Efficacy of transcutaneous electrical acupoint stimulation combined with diazepam for acute alcohol withdrawal syndrome: A double-blind randomized sham-controlled trial.,,2020,,['acute alcohol withdrawal syndrome'],['transcutaneous electrical acupoint stimulation combined with diazepam'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0236663', 'cui_str': 'Alcohol withdrawal syndrome'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}]",[],,0.575961,,"[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Qianfoshan Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Department of Substance Abuse, Qingdao Mental Health Center, Qingdao, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Department of Substance Abuse, Qingdao Mental Health Center, Qingdao, China.'}, {'ForeName': 'Cuiluan', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Substance Abuse, Shandong Mental Health Center Affiliated to Jining Medical University, Jinan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Jian', 'Affiliation': 'Department of Substance Abuse, Shandong Mental Health Center Affiliated to Jining Medical University, Jinan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'Department of Substance Abuse, Shandong Mental Health Center Affiliated to Jining Medical University, Jinan, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Substance Abuse, Shandong Mental Health Center Affiliated to Jining Medical University, Jinan, China.'}]",The Journal of international medical research,['10.1177/0300060520910052']
8,32340640,Impact of a nutrition education programme on preschool children's willingness to consume fruits and vegetables.,"OBJECTIVE
To evaluate the impact of a preschool-based nutrition education programme consisting of twelve 'hands on' nutrition education lessons delivered during the school year on young children's willingness to consume fruits and vegetables.
DESIGN
Quasi-experimental, pre-post design including the collection of plate waste evaluation data at the start and end of the 2015-2016 school year within two groups: (1) randomly selected classrooms receiving the intervention and (2) within conveniently sampled preschool classrooms not receiving the intervention serving as a comparison group.
SETTING
Centre-based preschool programmes serving low-income families in the Denver metro area.
PARTICIPANTS
Three- to five-year-old children in preschool classrooms participating in the intervention during the 2015-2016 school year (n 308) and children enrolled in comparison classrooms (n 215).
RESULTS
Repeated-measures logit models assessed whether increases in the odds of consuming small samples of fruits and vegetables between Time 1 (pre-intervention) and Time 2 (post-intervention) were different for children within the intervention group compared with the comparison group. Analyses showed that the change over time in consumption of the three vegetable samples varied by intervention status with greater change occurring among children within the intervention group (edamame: P = 0·001; cauliflower: P ≤ 0·0001 and red pepper: P ≤ 0·0001). Unlike vegetables, the change over time in consumption of the two fruit samples was not different between children within the intervention and comparison groups.
CONCLUSIONS
An experiential-learning nutrition education programme can positively influence eating behaviours of low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables.",2020,An experiential-learning nutrition education programme can positively influence eating behaviours of low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables.,"[""preschool children's willingness to consume fruits and vegetables"", ""twelve 'hands on' nutrition education lessons delivered during the school year on young children's willingness to consume fruits and vegetables"", 'Three- to five-year-old children in preschool classrooms participating in the intervention during the 2015-2016 school year (n 308) and children enrolled in comparison classrooms (n 215', 'Centre-based preschool programmes serving low-income families in the Denver metro area', 'low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables']","['preschool-based nutrition education programme', 'nutrition education programme', 'randomly selected classrooms receiving the intervention and (2) within conveniently sampled preschool classrooms not receiving the intervention serving as a comparison group']",['eating behaviours'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0163373,An experiential-learning nutrition education programme can positively influence eating behaviours of low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables.,"[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Melnick', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Farewell', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Quinlan', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'LaFlamme', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Brogden', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Scarbro', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}, {'ForeName': 'Jini E', 'Initials': 'JE', 'LastName': 'Puma', 'Affiliation': 'Rocky Mountain Prevention Research Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO80045, USA.'}]",Public health nutrition,['10.1017/S1368980019005032']
9,32340841,Effect of dapagliflozin on cardiac function in people with type 2 diabetes and albuminuria - A double blind randomized placebo-controlled crossover trial.,"AIMS
Sodium glucose transport inhibitors (SGLT2i) can reduce risk of heart failure (HF) and cardiovascular death in people with type 2 diabetes (T2D) and existing cardiovascular disease. Our aim was to examine the effect of the SGLT2i dapagliflozin on cardiac function in people with T2D and albuminuria.
METHODS
A secondary analysis of a double-blind, randomized, cross-over study of 12 weeks treatment with dapagliflozin 10 mg versus placebo. Myocardial function was assessed by echocardiography and biomarkers of cardiac risk were measured. An exploratory diastolic composite of echocardiographic variables was computed.
RESULTS
Of the 36 participants completing the study 89% were male, mean age 64 ± 8 years, diabetes duration 16.4 ± 4.7 years and HbA 1c 73 ± 15 mmol/mol (8.9 ± 1.4%), 30.6% had former cardiovascular events and 32% had macroalbuminuria. Mean left ventricular ejection fraction (LVEF) was 55.4% after placebo and 54.3% after dapagliflozin (p = 0.15), global longitudinal strain -16.1 vs. -15.9, (p = 0.64), E/e' 7.6 vs. 7.6 (p = 0.082), and tissue Doppler velocity e' 10.0 vs. 10.6 (p = 0.05). The composite score showed diastolic function improvement of 19.8% (p = 0.021). No other significant changes were observed.
CONCLUSIONS
Dapagliflozin may have minor effects on diastolic function in people with T2D, albuminuria and preserved LVEF.",2020,"Mean left ventricular ejection fraction (LVEF) was 55.4% after placebo and 54.3% after dapagliflozin (p = 0.15), global longitudinal strain -16.1 vs. -15.9, (p = 0.64), E/e' 7.6 vs. 7.6 (p = 0.082), and tissue Doppler velocity e' 10.0 vs. 10.6 (p = 0.05).","['people with T2D and albuminuria', 'people with T2D, albuminuria and preserved LVEF', '36 participants completing the study 89% were male, mean age 64\u202f±\u202f8\u202fyears, diabetes duration 16.4\u202f±\u202f4.7\u202fyears and HbA 1c 73\u202f±\u202f15\u202fmmol/mol (8.9\u202f±\u202f1.4%), 30.6% had former cardiovascular events and 32% had macroalbuminuria', 'people with type 2 diabetes and albuminuria ', 'people with type 2 diabetes (T2D) and existing cardiovascular disease']","['dapagliflozin', 'placebo', 'SGLT2i dapagliflozin', 'Dapagliflozin', 'dapagliflozin 10\u202fmg versus placebo', 'Sodium glucose transport inhibitors (SGLT2i']","['Myocardial function', 'heart failure (HF) and cardiovascular death', 'Mean left ventricular ejection fraction (LVEF', 'cardiac function', 'diastolic function improvement', 'diastolic function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}]",89.0,0.600806,"Mean left ventricular ejection fraction (LVEF) was 55.4% after placebo and 54.3% after dapagliflozin (p = 0.15), global longitudinal strain -16.1 vs. -15.9, (p = 0.64), E/e' 7.6 vs. 7.6 (p = 0.082), and tissue Doppler velocity e' 10.0 vs. 10.6 (p = 0.05).","[{'ForeName': 'Mie K', 'Initials': 'MK', 'LastName': 'Eickhoff', 'Affiliation': 'Steno Diabetes Center Copenhagen, Denmark.'}, {'ForeName': 'Flemming J', 'Initials': 'FJ', 'LastName': 'Olsen', 'Affiliation': 'Herlev Gentofte Hospital, Department of Cardiology, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Frimodt-Møller', 'Affiliation': 'Steno Diabetes Center Copenhagen, Denmark.'}, {'ForeName': 'Lars J', 'Initials': 'LJ', 'LastName': 'Diaz', 'Affiliation': 'Steno Diabetes Center Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Herlev Gentofte Hospital, Department of Endocrinology, Denmark.'}, {'ForeName': 'Magnus T', 'Initials': 'MT', 'LastName': 'Jensen', 'Affiliation': 'Herlev Gentofte Hospital, Department of Cardiology, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Denmark; University of Copenhagen, Department of Clinical Medicine, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Denmark. Electronic address: Frederik.persson@regionh.dk.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107590']
10,32340871,Effect of aspirin dose on hemocompatibility-related outcomes with a magnetically levitated left ventricular assist device: An analysis from the MOMENTUM 3 study.,"BACKGROUND
Aspirin (ASA) anti-platelet therapy is mandated with left ventricular assist devices (LVADs) to prevent hemocompatibility-related adverse events (HRAEs). However, the optimal dose of ASA with HeartMate 3 (HM3) LVAD is unknown.
METHODS
In an exploratory analysis of HM3-supported patients in the MOMENTUM 3 study (NCT02224755), 2 groups were analyzed: usual-dose (325 mg) and low-dose (81 mg) ASA with anti-coagulation targeted to an international normalized ratio of 2.0 to 3.0. Exclusion criteria included patients not receiving either ASA 81 mg or 325 mg, those with HRAEs ≤7 days after device implantation, and those receiving >1 anti-platelet agent. The primary end-point was survival free from HRAEs (non-surgical bleeding, pump thrombosis, stroke, and peripheral arterial thromboembolic events) at 2 years.
RESULTS
Overall, 321 HM3 patients (usual-dose: n = 141, low-dose: n = 180) were included in this analysis. Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA. At 2 years, a similar proportion of patients in the usual- and low-dose groups (43.4% vs 45.3%, p = 0.94) met the primary end-point. There were no differences in survival free from hemorrhagic (usual-dose: 54.4% vs low-dose: 51.7%, p = 0.42) or thrombotic (usual-dose: 76.8% vs low-dose: 75.7%, p = 0.92) events.
CONCLUSIONS
Usual- and low-dose ASA revealed similar rates of bleeding and thrombotic events in HM3 LVAD-supported patients within the MOMENTUM 3 trial. Whether ASA therapy provides any meaningful therapeutic effect in patients treated by the HM3 LVAD remains to be determined.",2020,"Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA.","['321 HM3 patients (usual-dose: n\u202f=\u202f141, low-dose: n\u202f=\u202f180']","['Aspirin (ASA) anti-platelet therapy', 'ASA', 'aspirin']","['thrombotic', 'survival free from HRAEs (non-surgical bleeding, pump thrombosis, stroke, and peripheral arterial thromboembolic events', 'rates of bleeding and thrombotic events', 'survival free from hemorrhagic']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}]",180.0,0.064419,"Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA.","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.'}, {'ForeName': 'Paolo C', 'Initials': 'PC', 'LastName': 'Colombo', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cleveland', 'Affiliation': 'Department of Surgery, University of Colorado Hospital, Aurora, Colorado.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Samer S', 'Initials': 'SS', 'LastName': 'Najjar', 'Affiliation': 'Department of Medicine, Medstar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Nahush A', 'Initials': 'NA', 'LastName': 'Mokadam', 'Affiliation': 'Department of Surgery, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Surgery, Ochsner Medical Center, New Orleans, Louisiana.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Crandall', 'Affiliation': 'Division of Cardiology Department of Medicine, Abbott, Chicago, Illinois.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Division of Cardiology Department of Medicine, Abbott, Chicago, Illinois.'}, {'ForeName': 'Ulrich P', 'Initials': 'UP', 'LastName': 'Jorde', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York. Electronic address: ujorde@montefiore.org.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.03.001']
11,32339768,Risk reduction through family therapy (RRFT): Protocol of a randomized controlled efficacy trial of an integrative treatment for co-occurring substance use problems and posttraumatic stress disorder symptoms in adolescents who have experienced interpersonal violence and other traumatic events.,"Decades of research demonstrate that childhood exposure to traumatic events, particularly interpersonal violence experiences (IPV; sexual abuse, physical abuse, witnessing violence), increases risk for negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD). Despite this well-established link-including empirical support for shared etiological and functional connections between SUP and PTSD -the field has been void of a gold standard treatment for adolescent populations. To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events. The purpose of this paper is to provide a detailed description of the design and methods of this RCT designed to reduce SUP, PTSD symptoms, and related risk behaviors, with outcomes measured from pre-treatment through 18 months post-entry. Specifically, the recruitment and sampling procedures, assessment measures and methods, description of the intervention, and planned statistical approaches to evaluating the full range of outcomes are detailed. Clinical and research implications of this work are also discussed.",2020,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","['adolescents who have experienced IPV and other traumatic events', 'adolescents who have experienced interpersonal violence and other traumatic events']","['integrative treatment', 'Risk Reduction through Family Therapy (RRFT']","['SUP, PTSD symptoms, and related risk behaviors', 'negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.0401951,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","[{'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'de Arellano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Carla Kmett', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: danielso@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106012']
12,32339933,"Comments on ""A multicentre prospective randomized controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents"": Letter to the editor and authors reponse.",,2020,,['nursing home residents'],['static air mattress and alternating air pressure mattress'],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0001876', 'cui_str': 'Air pressure'}]",[],,0.0890545,,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fagart', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France. Electronic address: willy.fagart@chu-nimes.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De La Bachelerie', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blot', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'Département de Médecine Physique et de Réadaptation, CHU de Nîmes, 30029 Nîmes, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chevalier', 'Affiliation': 'Laboratoire De Biostatistique, Épidémiologie, Santé Publique, Informatique Médicale, CHU de Nîmes, 30029 Nîmes, France.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103547']
13,32343994,Effects of electronic cigarette on platelet and vascular function after four months of use.,"We examined the effects of electronic cigarette on platelet and vascular function after 4 months of use compared to tobacco smoking. Forty smokers without cardiovascular disease were randomized to smoke either conventional cigarettes or an electronic cigarette (nicotine concentration of 12 mg/ml). At baseline and after four months, we measured a) platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level. After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045). Conversely, compared to smoking, vaping resulted in greater reduction of exhaled CO (6.9 ppm vs 2.6, p for interaction < 0.001), improvement of PWV (decrease of 0.8 m/s vs increase of 0.8 m/s, p for interaction = 0.020) and reduction of MDA (reduction 0.13 vs increase 0.19 nmol/L, p for interaction = 0.035). Switching to electronic cigarette for 4 months has a neutral effect on platelet function while it reduces arterial stiffness and oxidative stress compared to tobacco smoking.",2020,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).",['Forty smokers without cardiovascular disease'],"['electronic cigarette', 'conventional cigarettes or an electronic cigarette (nicotine concentration of 12\u202fmg/ml']","['exhaled CO', 'platelet function', 'platelet and vascular function', 'improvement of PWV', 'arterial stiffness and oxidative stress', 'reduction of MDA', 'platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.0199673,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: ignoik@gmail.com.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Gavriella', 'Initials': 'G', 'LastName': 'Kostelli', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Kallirhoe', 'Initials': 'K', 'LastName': 'Kourea', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kyriakou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Kypraiou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Plotas', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Thymis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Argirios E', 'Initials': 'AE', 'LastName': 'Tsantes', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111389']
14,32281738,"Identifying Cranberry Juice Consumers with Predictive OPLS-DA Models of Plasma Metabolome and Validation of Cranberry Juice Intake Biomarkers in a Double-Blinded, Randomized, Placebo-Controlled, Cross-Over Study.","SCOPE
Methods to verify cranberry juice consumption are lacking. Predictive multivariate models built upon validated biomarkers may help to verify human consumption of a food using a nutrimetabolomics approach.
METHODS
A 21-day double-blinded, randomized, placebo-controlled, cross-over study was conducted among healthy young women aged 1829. Plasma was collected at baseline and after 3-day and 21-day consumption of cranberry or placebo juice. Plasma metabolome was analyzed using UHPLC coupled with high resolution mass spectrometry.
RESULTS
18 discriminant metabolites in positive mode and 18 discriminant metabolites in negative mode from a previous 3-day open-label study were re-discovered in the present blinded study. Predictive orthogonal partial least squares discriminant analysis (OPLS-DA) models were able to identify cranberry juice consumers over a placebo juice group with 96.9% correction rates after 3-day consumption in both positive and negative mode. This present study revealed 84 and 109 additional discriminant metabolites in positive and negative mode, respectively. Twelve of them were tentatively identified.
CONCLUSION
Cranberry juice consumers were classified with high correction rates using predictive OPLS-DA models built upon validated plasma biomarkers. Additional biomarkers were tentatively identified. These OPLS-DA models and biomarkers provided an objective approach to verify participant compliance in future clinical trials.",2020,The models were able to identify cranberry juice consumers over placebo juice group with 96.9% correction rates after 3-day consumption at both positive and negative mode.,['healthy young women aging 18-29'],"['placebo juice', 'cranberry or placebo juice', 'placebo']",['Plasma metabolome'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}]",,0.38251,The models were able to identify cranberry juice consumers over placebo juice group with 96.9% correction rates after 3-day consumption at both positive and negative mode.,"[{'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Food Science and Human Nutrition Department, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL, 32611, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA, 02349, USA.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Su', 'Affiliation': 'Department of Statistics, College of Liberal Arts and Sciences, University of Florida, Gainesville, FL, 32611, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA, 02349, USA.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Food Science and Human Nutrition Department, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL, 32611, USA.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901242']
15,29774787,Variability of attention bias in socially anxious adolescents: differences in fixation duration toward adult and adolescent face stimuli.,"Prior research on attention bias in anxious youth, often utilising a visual dot probe task, has yielded inconsistent findings, which may be due to how bias is assessed and/or variability in the phenomenon. The present study utilises eye gaze tracking to assess attention bias in socially anxious adolescents, and explores several methodological and within-subject factors that may contribute to variability in attention bias. Attention bias to threat was measured in forty-two treatment-seeking adolescents (age 12-16 years) diagnosed with Social Anxiety Disorder. Bias scores toward emotional stimuli (vigilant attention) and bias scores away from emotional stimuli (avoidant attention) were explored. Bias scores changed between vigilance and avoidance within individuals and over the course of stimulus presentation. These differences were not associated with participant characteristics nor with self-reported social anxiety symptoms. However, clinician rated severity of social anxiety, explained a significant proportion of variance in the bias scores for adult, but not the adolescent, stimuli. Variability in attention bias among socially anxious adolescents is common and varies as a function of stimulus duration and type. Results may inform stimulus selection for future research.",2019,These differences were not associated with participant characteristics nor with self-reported social anxiety symptoms.,"['socially anxious adolescents', 'anxious youth', 'forty-two treatment-seeking adolescents (age 12-16 years) diagnosed with Social Anxiety Disorder']",[],"['Bias scores toward emotional stimuli (vigilant attention) and bias scores away from emotional stimuli (avoidant attention', 'social anxiety symptoms', 'social anxiety']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",[],"[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0234497,These differences were not associated with participant characteristics nor with self-reported social anxiety symptoms.,"[{'ForeName': 'Andrea Trubanova', 'Initials': 'AT', 'LastName': 'Wieckowski', 'Affiliation': 'a Department of Psychology (0436) , Virginia Tech , Blacksburg , USA.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Capriola-Hall', 'Affiliation': 'a Department of Psychology (0436) , Virginia Tech , Blacksburg , USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Elias', 'Affiliation': 'a Department of Psychology (0436) , Virginia Tech , Blacksburg , USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'a Department of Psychology (0436) , Virginia Tech , Blacksburg , USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'White', 'Affiliation': 'a Department of Psychology (0436) , Virginia Tech , Blacksburg , USA.'}]",Cognition & emotion,['10.1080/02699931.2018.1476322']
16,32347216,Grinding the intaglio surface of yttria partially- and fully-stabilized zirconia polycrystals restorations: Effect on their fatigue behavior.,"This study evaluated the effects of diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ) adhesively cemented to dentin analogue substrate on the fatigue failure load, cycle number until failure, surface micromorphology and phase transformation. Disc-shaped specimens were produced from second (Katana ML-HT, Kuraray) and third-generation zirconia (Katana STML, Kuraray) and randomly allocated (n = 15) into two groups according to the intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface). The ceramic discs were adhesively cemented (Multilink Automix System) onto dentin analogue discs. Fatigue tests were executed by the step-stress method. The obtained data were analyzed by Kaplan Meier and Mantel-Cox tests. In addition, surface topography, roughness, phase transformation and fractography analyses were performed. SEM analysis showed that grinding increased the surface roughness and introduced defects in zirconia from both generations. Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 N < grinding: 1600 N), while these same outcomes were reduced by grinding for the third-generation zirconia significantly (control: 766.67 N > grinding: 620 N). Thus, clinical adjustments with diamond burs damage the fatigue behavior of adhesively cemented third-generation zirconia.",2020,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ",[],"['intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface', 'diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ']","['surface roughness and introduced defects in zirconia', 'Fatigue tests', 'fatigue failure load, number of cycles to failure and survival rates', 'fatigue behavior']",[],"[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0292957', 'cui_str': 'yttria'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0215012,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Bruna Dias', 'Initials': 'BD', 'LastName': 'Ilha', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: brunailha2@hotmail.com.'}, {'ForeName': 'Michele Mirian', 'Initials': 'MM', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: mmayodontologia@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103800']
17,32347365,Intraoperative radiotherapy for resectable advanced lower rectal cancer-final results of a randomized controlled trial (UMIN000021353).,"AIM
Pelvic autonomic nerve preservation (PANP) is useful to preserve voiding and sexual function after rectal cancer surgery. The aim of this study was to investigate the benefit of intraoperative radiotherapy (IORT) to have complete PANP without affecting oncological outcomes.
METHODS
Patients undergoing potentially curative resection of the rectum were included. They were randomized to intraoperative radiotherapy of the completely preserved bilateral pelvic nerve plexuses (IORT group) or the control group without IORT, but with limited nerve preservation. The primary endpoint was pelvic sidewall recurrence. Moreover, patients' clinicopathologic parameters, postoperative complications, voiding function, and other oncologic outcomes were compared.
RESULTS
From 79 patients, three were excluded from analysis, resulting in 38 patients in each group. Patients' demographic and pathological parameters were well balanced between the two groups. The trial was terminated prematurely in July 2017, because distant metastasis-free survivals were found to be significantly worse in the IORT group compared to the control group (odds ratio 2.554; 95% CI, 1.041 ~ 6.269; p = 0.041). Neither overall survival nor pelvic sidewall recurrence did differ between the two groups (overall survival: odds ratio 1.264; 95% CI, 0.523~3.051; p = 0.603/pelvic sidewall recurrence; odds ratio 1.350; 95% CI, 0.302~6.034; p = 0.694). Postoperative complications did not differ between the groups; however, the urinary function was significantly better in the IORT group in the short and long term.
CONCLUSION
With the aid of IORT, complete PANP can be done without increase of pelvic sidewall recurrence; however, IORT may increase the incidence of distant metastases. Therefore, IORT cannot be recommended as a standard therapy to compensate less radical resection for advanced lower rectal cancer.",2020,"Postoperative complications did not differ between the groups; however, the urinary function was significantly better in the IORT group in the short and long term.
","['Patients undergoing potentially curative resection of the rectum were included', 'From 79 patients, three were excluded from analysis, resulting in 38 patients in each group', 'after rectal cancer surgery', 'resectable advanced lower rectal cancer']","['Intraoperative radiotherapy', 'intraoperative radiotherapy of the completely preserved bilateral pelvic nerve plexuses (IORT group) or the control group without IORT', 'intraoperative radiotherapy (IORT', 'IORT', 'Pelvic autonomic nerve preservation (PANP']","['urinary function', 'pelvic sidewall recurrence', 'distant metastasis-free survivals', 'overall survival nor pelvic sidewall recurrence', 'voiding and sexual function', 'Postoperative complications', 'clinicopathologic parameters, postoperative complications, voiding function, and other oncologic outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205797', 'cui_str': 'Inferior hypogastric plexus structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0206250', 'cui_str': 'Autonomic nerve structure'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.216372,"Postoperative complications did not differ between the groups; however, the urinary function was significantly better in the IORT group in the short and long term.
","[{'ForeName': 'Tadahiko', 'Initials': 'T', 'LastName': 'Masaki', 'Affiliation': 'Department of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan. masaki@ks.kyorin-u.ac.jp.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Kishiki', 'Affiliation': 'Department of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kojima', 'Affiliation': 'Department of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Aso', 'Affiliation': 'Department of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Beniya', 'Affiliation': 'Department of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Tonari', 'Affiliation': 'Department of Radiation Oncology, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Takayama', 'Affiliation': 'Department of Radiation Oncology, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Nobutsugu', 'Initials': 'N', 'LastName': 'Abe', 'Affiliation': 'Department of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Sunami', 'Affiliation': 'Department of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01875-2']
18,32343890,Olaparib for Metastatic Castration-Resistant Prostate Cancer.,"BACKGROUND
Multiple loss-of-function alterations in genes that are involved in DNA repair, including homologous recombination repair, are associated with response to poly(adenosine diphosphate-ribose) polymerase (PARP) inhibition in patients with prostate and other cancers.
METHODS
We conducted a randomized, open-label, phase 3 trial evaluating the PARP inhibitor olaparib in men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone). All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair. Cohort A (245 patients) had at least one alteration in BRCA1 , BRCA2 , or ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue. Patients were randomly assigned (in a 2:1 ratio) to receive olaparib or the physician's choice of enzalutamide or abiraterone (control). The primary end point was imaging-based progression-free survival in cohort A according to blinded independent central review.
RESULTS
In cohort A, imaging-based progression-free survival was significantly longer in the olaparib group than in the control group (median, 7.4 months vs. 3.6 months; hazard ratio for progression or death, 0.34; 95% confidence interval, 0.25 to 0.47; P<0.001); a significant benefit was also observed with respect to the confirmed objective response rate and the time to pain progression. The median overall survival in cohort A was 18.5 months in the olaparib group and 15.1 months in the control group; 81% of the patients in the control group who had progression crossed over to receive olaparib. A significant benefit for olaparib was also seen for imaging-based progression-free survival in the overall population (cohorts A and B). Anemia and nausea were the main toxic effects in patients who received olaparib.
CONCLUSIONS
In men with metastatic castration-resistant prostate cancer who had disease progression while receiving enzalutamide or abiraterone and who had alterations in genes with a role in homologous recombination repair, olaparib was associated with longer progression-free survival and better measures of response and patient-reported end points than either enzalutamide or abiraterone. (Funded by AstraZeneca and Merck Sharp & Dohme; PROfound ClinicalTrials.gov number, NCT02987543.).",2020,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"['Cohort A (245 patients) had at least one alteration in BRCA1 , BRCA2 , or ATM ; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone', 'patients with prostate and other cancers', 'men with metastatic castration-resistant prostate cancer who had disease progression while receiving', 'Metastatic Castration-Resistant Prostate Cancer']","['PARP inhibitor olaparib', 'enzalutamide or abiraterone', ""olaparib or the physician's choice of enzalutamide or abiraterone (control"", 'Olaparib']","['objective response rate and the time to pain progression', 'Anemia and nausea', 'median overall survival', 'imaging-based progression-free survival']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0103097', 'cui_str': 'ammonium tetrathiomolybdate'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",245.0,0.264475,All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair.,"[{'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Twardowski', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Burgents', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kohlmann', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Adelman', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': ""From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).""}]",The New England journal of medicine,['10.1056/NEJMoa1911440']
19,32344891,Patient-Reported Outcome Measures (PROMs) for Two Implant Placement Techniques in Sinus Region (Bone Graft versus Computer-Aided Implant Surgery): A Randomized Prospective Trial.,"PURPOSE
To assess patient-reported outcomes measures (PROMs) for two implant placement techniques in cases of sinus bone atrophy (bone graft surgery (BGS) versus computer-aided implant surgery (CAIS)), after surgery and one year later, and to evaluate the clinical success of both treatments.
METHODS
Sixty patients with bone atrophy in the posterior maxilla and in need of implant placement were randomly assigned to two groups, and in accordance with the case report form (CRF), 30 were treated with BGS and 30 with CAIS. Immediately after treatment and one year later, PROMs were assessed, and the clinical success of both treatments was evaluated.
RESULTS
No significant differences were found between BGS and CAIS with regard to the following: loss of implants ( p = 492); patient recommendation ( p = 210); duration of surgery ( p = 987); pain on the intervention day ( p = 512); pain in the week after intervention ( p = 299); and complications in the stage of surgery ( p = 1.00). Similarly, at one year, no differences were found with regard to the following: pain around implant ( p = 481); infection of implants ( p = 491); abnormal radiographic imaging ( p = 226); occurrence of undesirable events ( p = 1.00); loss of one of the implants ( p = 1.00); plaque detection ( p = 1.00); bleeding on probing ( p = 236); and presence of keratinized mucosa ( p = 226). However, a significant difference was found among BGS and CAIS with regard to the number of consultations ( p = 0001); number of implants placed ( p = 033); and treatment difficulty ( p = 0369). Significant differences were found for peri-implantitis ( p = 0481) and radiology of craterization ( p = 020) in clinical examination at the first year.
CONCLUSION
Treatment difficulty and number of consultations were higher for BGS than for CAIS, as well as peri-implantitis and bone craterization at one year, indicating significant differences between the two treatments. However, there were no statistically significant differences between BGS and CAIS regarding the other PROMs, at placement and after one year.",2020,"Significant differences were found for peri-implantitis ( p = 0481) and radiology of craterization ( p = 020) in clinical examination at the first year.
",['Sixty patients with bone atrophy in the posterior maxilla and in need of implant placement'],"['sinus bone atrophy (bone graft surgery (BGS) versus computer-aided implant surgery (CAIS', 'BGS and 30 with CAIS']","['BGS and CAIS', 'plaque detection', 'abnormal radiographic imaging', 'occurrence of undesirable events', 'peri-implantitis and bone craterization', 'pain around implant', 'pain', 'peri-implantitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1389037', 'cui_str': 'Bone atrophy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1389037', 'cui_str': 'Bone atrophy'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0064494', 'cui_str': 'carboxyamido-triazole'}, {'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}]","[{'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}, {'cui': 'C0064494', 'cui_str': 'carboxyamido-triazole'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0457276', 'cui_str': 'Radiographic imaging - action'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",60.0,0.0360508,"Significant differences were found for peri-implantitis ( p = 0481) and radiology of craterization ( p = 020) in clinical examination at the first year.
","[{'ForeName': 'Ghazwan', 'Initials': 'G', 'LastName': 'Almahrous', 'Affiliation': 'Department of Oral Surgery, Dental School, University Claude Bernard, 69003 Lyon, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'David-Tchouda', 'Affiliation': 'ThEMAS TIMC UMR CNRS 5525, Grenoble Joseph Fourier University, 38041 Grenoble, France.'}, {'ForeName': 'Aboubacar', 'Initials': 'A', 'LastName': 'Sissoko', 'Affiliation': 'Cellule Data Stat, University Hospital of Grenoble, 38700 Grenoble, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Rancon', 'Affiliation': 'Department of Oral Surgery, Hospices Civils, 69003 Lyon, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'ThEMAS TIMC UMR CNRS 5525, Grenoble Joseph Fourier University, 38041 Grenoble, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fortin', 'Affiliation': 'Department of Oral Surgery, Dental School, University Claude Bernard, 69003 Lyon, France.'}]",International journal of environmental research and public health,['10.3390/ijerph17092990']
20,32347804,Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research.,"BACKGROUND
Mobile messaging is often used in behavioral weight loss interventions, yet little is known as to the extent to which they contribute to weight loss when part of a multicomponent treatment package. The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.
OBJECTIVE
This study describes the use of MOST to develop a messaging intervention as a component to test as part of a weight loss treatment package in a subsequent optimization trial.
METHODS
On the basis of our conceptual model, a text message intervention was created to support self-regulation of weight-related behaviors. We tested the messages in the ENLIGHTEN feasibility pilot study. Adults with overweight and obesity were recruited to participate in an 8-week weight loss program. Participants received a commercially available self-monitoring smartphone app, coaching calls, and text messages. The number and frequency of text messages sent were determined by individual preferences, and weight was assessed at 8 weeks.
RESULTS
Participants (n=9) in the feasibility pilot study lost 3.2% of their initial body weight over the 8-week intervention and preferred to receive 1.8 texts per day for 4.3 days per week. Researcher burden in manually sending messages was high, and the cost of receiving text messages was a concern. Therefore, a fully automated push notification system was developed to facilitate sending tailored daily messages to participants to support weight loss.
CONCLUSIONS
Following the completion of specifying the conceptual model and the feasibility pilot study, the message intervention went through a final iteration. Theory and feasibility pilot study results during the preparation phase informed critical decisions about automation, frequency, triggers, and content before inclusion as a treatment component in a factorial optimization trial.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01814072; https://clinicaltrials.gov/ct2/show/NCT01814072.",2020,"The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.
",['Adults with overweight and obesity were recruited to participate in an 8-week weight loss program'],"['commercially available self-monitoring smartphone app, coaching calls, and text messages']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],,0.0318916,"The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.
","[{'ForeName': 'Angela Fidler', 'Initials': 'AF', 'LastName': 'Pfammatter', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Sara Hoffman', 'Initials': 'SH', 'LastName': 'Marchese', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}]",JMIR formative research,['10.2196/16297']
21,32348291,A Clinical Trial to Increase Self-Monitoring of Physical Activity and Eating Behaviors Among Adolescents: Protocol for the ImPACT Feasibility Study.,"BACKGROUND
Severe obesity among youths (BMI for age≥120th percentile) has been steadily increasing. The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight loss interventions, which highlights that a family-based treatment approach is warranted. This strategy has been successful in our existing evidence-based pediatric weight management program, Brenner Families in Training (Brenner FIT). However, this program relies on face-to-face encounters, which are limited by the time constraints of the families enrolled in treatment.
OBJECTIVE
This study aims to refine and test a tailored suite of mobile health (mHealth) components to augment an existing evidence-based pediatric weight management program.
METHODS
Study outcomes will include acceptability from a patient and clinical staff perspective, feasibility, and economic costs relative to the established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT]). The Brenner mFIT intervention will consist of 6 mHealth components designed to increase patient and caregiver exposure to Brenner FIT programmatic content including the following: (1) a mobile-enabled website, (2) dietary and physical activity tracking, (3) caregiver podcasts (n=12), (4) animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based on a web-based dashboard. For the study, 80 youths with obesity (aged 13-18 years) and caregiver dyads will be randomized to Brenner FIT or Brenner mFIT. All participants will complete baseline measures before randomization and at 3- and 6-month follow-up points.
RESULTS
This study was approved by the Institutional Review Board in July 2019, funded in August 2019, and will commence enrollment in April 2020. The results of the study are expected to be published in the fall/winter of 2021.
CONCLUSIONS
The results of this study will be used to inform a large-scale implementation-effectiveness clinical trial.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/18098.",2020,"The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight-loss interventions, which highlights that a family-based treatment approach is warranted.","['July 2019, funded in August 2019, and will commence enrollment in April 2020', 'Severe obesity among the youth (BMI for age ≥120th percentile', '80 youths with obesity (aged 13-18 years) and caregiver dyads']","['established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT', 'animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based-upon a Web-based dashboard', 'Brenner FIT or Brenner mFIT']",['Physical Activity and Eating Behaviors'],"[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",80.0,0.0505492,"The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight-loss interventions, which highlights that a family-based treatment approach is warranted.","[{'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Moore', 'Affiliation': 'Department of Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Dilley', 'Affiliation': 'Department of Plastic Surgery, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Camelia R', 'Initials': 'CR', 'LastName': 'Singletary', 'Affiliation': 'Department of Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Skelton', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Vahé', 'Initials': 'V', 'LastName': 'Heboyan', 'Affiliation': 'Department of Interdisciplinary Health Sciences, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'De Leo', 'Affiliation': 'Department of Interdisciplinary Health Sciences, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education & Behavior, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McGrievy', 'Affiliation': 'Office of Operations and Accreditation, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Ip', 'Affiliation': 'Department of Biostatistics & Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}]",JMIR research protocols,['10.2196/18098']
22,32279099,"Comment on the article ""The antifibrinolytic and anti-inflammatory effects of a high initial-dose tranexamic acid in total knee arthroplasty: a randomized controlled trial"".",,2020,,['total knee arthroplasty'],['tranexamic acid'],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.103612,,"[{'ForeName': 'Saubhik', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, 834009, India. drsaubhikk@hotmail.com.'}]",International orthopaedics,['10.1007/s00264-020-04554-5']
23,32278029,"Addition of Chinese herbal remedy, Tongguan Capsules, to the standard treatment in patients with myocardial infarction improve the ventricular reperfusion and remodeling: Proteomic analysis of possible signaling pathways.","ETHNOPHARMACOLOGICAL RELEVANCE
Tongguan Capsules (TGC), a patented Chinese herbal remedy containing Salvia miltiorrhiza, Astragalus membranaceus, Borneolum syntheticum and Grasshopper, has been previously tested in the experimental model of animal hearts subjected to ischemia/reperfusion injury and its cardioprotective effect has been described.
AIM OF THE STUDY
This clinical trial was aimed at investigation whether the administration of TGC to patients suffered myocardial infarction (MI), would diminish dilation of the left ventricular (LV) and reduce development of the adverse clinical consequences.
METHODS
Eligible patients were enrolled and randomized 1:1 to TGC (4.5 g/d for 6 months) superimposed on standard treatment for MI, or the control group receiving the standard protocol alone. The outcomes of this trial were valued after 6 months and reported as a mean change from the baseline in LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia that required the additional therapy within 6 months. In addition, arrays with a panel of specific antibodies were used to assess levels of major cytokines and other pathophysiologic markers, that prompted conclusions about the mechanisms of the ultimate clinical outcomes in both patient's subgroups.
RESULTS
Meaningfully, obtained results indicated that MI patients randomly assigned to the TGC treatment, demonstrated a significant reduction of LVESVI (-4.03 ± 0.73 vs. 1.59 ± 0.43 mL/m 2 , P < 0.001) and a lower incidence of the major adverse cardiovascular events (5.45% vs. 11.44%, P = 0.033). Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis.
CONCLUSION
Addition of TGC to the current conventional treatment of MI patients, significantly reduced their adverse LV remodeling and contributed to the more positive clinical outcome.
TRIAL REGISTRATION
ChiCTR-IPR-17011618.",2020,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","['Eligible patients', 'patients with myocardial infarction', 'patients suffered myocardial infarction (MI']","['TGC', 'Chinese herbal remedy, Tongguan Capsules', 'standard treatment for MI, or the control group receiving the standard protocol alone']","['levels of markers of myocardial apoptosis and fibrosis', 'LVESVI', 'major adverse cardiovascular events', 'LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia', 'adverse LV remodeling', 'serum levels of major inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C2605709', 'cui_str': 'tongguan'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.109447,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Yuanshen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Zeng', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Xujie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Qubo', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Biological Resource Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. Electronic address: minzhouzhang@aliyun.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Hinek', 'Affiliation': 'Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112794']
24,30232416,Ghrelin is impacted by the endogenous circadian system and by circadian misalignment in humans.,"The human circadian system regulates hunger independently of behavioral factors, resulting in a trough in the biological morning and a peak in the biological evening. However, the role of the only known orexigenic hormone, ghrelin, in this circadian rhythm is unknown. Furthermore, although shift work is an obesity risk factor, the separate effects of the endogenous circadian system, the behavioral cycle, and circadian misalignment on ghrelin has not been systematically studied. Here we show-by using two 8-day laboratory protocols-that circulating active (acylated) ghrelin levels are significantly impacted by endogenous circadian phase in healthy adults. Active ghrelin levels were higher in the biological evening than the biological morning (fasting +15.1%, P = 0.0001; postprandial +10.4%, P = 0.0002), consistent with the circadian variation in hunger (P = 0.028). Moreover, circadian misalignment itself (12-h behavioral cycle inversion) increased postprandial active ghrelin levels (+5.4%; P = 0.04). While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05). Our results provide possible mechanisms for the endogenous circadian rhythm in hunger, as well as for the increased risk of obesity among shift workers.",2019,"While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05).",['healthy adults'],[],"['Active ghrelin levels', 'postprandial active ghrelin levels', 'circadian variation in hunger', 'hunger']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]",,0.0482443,"While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05).","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA. jqian@bwh.harvard.edu.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Morris', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Caputo', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Garaulet', 'Affiliation': 'Department of Physiology, Chronobiology Laboratory, University of Murcia and Research Biomedical Institute of Murcia, Murcia, Spain.'}, {'ForeName': 'Frank A J L', 'Initials': 'FAJL', 'LastName': 'Scheer', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA. fscheer@bwh.harvard.edu.""}]",International journal of obesity (2005),['10.1038/s41366-018-0208-9']
25,32350909,Clinical benefit of ixazomib plus lenalidomide-dexamethasone in myeloma patients with non-canonical NF-κB pathway activation.,"OBJECTIVES
Evaluating potential relationships between progression-free survival (PFS) and tumor gene expression patterns and mutational status was an exploratory objective of the phase 3 TOURMALINE-MM1 study (NCT01564537) of ixazomib-lenalidomide-dexamethasone (IRd) vs placebo-Rd in 722 patients with relapsed/refractory multiple myeloma (MM).
METHODS
We utilized gene expression and mutation data from screening bone marrow aspirates to identify tumors with non-canonical nuclear factor-κB (NF-κB) signaling pathway activation.
RESULTS
DNA/RNA sequencing data were available for 339 (47.0%)/399 (55.2%) patients; 49/339 (14.5%) patients had non-canonical NF-κB pathway gene mutations (tumor-necrosis-factor receptor-associated factor 2, 3 [TRAF2, TRAF3], baculoviral-inhibitor-of-apoptosis repeat-containing 2/3 [BIRC2/3]), and PFS was significantly longer with IRd vs placebo-Rd in these patients (hazard ratio [HR] 0.23). In patients with lower TRAF3 expression (median not reached vs 11 months, HR 0.47) and higher NF-κB-inducing kinase (NIK) expression (median not reached vs 14 months, HR 0.45), both associated with non-canonical NF-κB pathway activation, PFS was significantly longer with IRd vs placebo-Rd. TRAF3 expression was decreased in patients harboring t(4;14) and 1q21 amplification, suggesting increased non-canonical NF-κB pathway activation.
CONCLUSIONS
Adding ixazomib to Rd provides clinical benefit in MM tumors with increased non-canonical NF-κB pathway activity. This is a potential mechanism for activity in 1q21 amplified high-risk tumors.",2020,"TRAF3 expression was decreased in patients harboring t(4;14) and 1q21 amplification, suggesting increased non-canonical NF-κB pathway activation.
","['myeloma patients with non-canonical NF-κB pathway activation', 'screening bone marrow aspirates to identify tumors with non-canonical nuclear factor-κB (NF-κB) signaling pathway activation', '722 patients with relapsed/refractory multiple myeloma (MM']","['ixazomib-lenalidomide-dexamethasone (IRd) vs placebo-Rd', 'ixazomib plus lenalidomide-dexamethasone']","['TRAF3 expression', 'TRAF2, TRAF3], baculoviral-inhibitor-of-apoptosis repeat-containing 2/3 [BIRC2/3]), and PFS', 'NF-κB-inducing kinase (NIK) expression']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0857285', 'cui_str': 'Bone marrow aspirate'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0295022', 'cui_str': 'CD40 Receptor-Associated Factor 1'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0258441', 'cui_str': 'TRAF2'}, {'cui': 'C0079005', 'cui_str': 'Baculoviridae'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}]",722.0,0.0386312,"TRAF3 expression was decreased in patients harboring t(4;14) and 1q21 amplification, suggesting increased non-canonical NF-κB pathway activation.
","[{'ForeName': 'Ajeeta B', 'Initials': 'AB', 'LastName': 'Dash', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Berg', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Jianchang', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Hematology, IUC-Oncopole, Toulouse, France.'}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'Southern Alberta Cancer Research Institute, Calgary, AB, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Hematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Di Bacco', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}]",European journal of haematology,['10.1111/ejh.13435']
26,32349528,"Effects of Kinesio Taping and compression stockings on pain, edema, functional capacity and quality of life in patients with chronic venous disease: a randomized controlled trial.","OBJECTIVE
The aim of this study was to compare the effects of Kinesio Taping and compression stockings on pain, edema, functional capacity and quality of life in patients with chronic venous disease (CVD).
DESIGN
This is a prospective, randomized, controlled, single-blind clinical trial.
SETTING
The study was conducted in a physiotherapy and rehabilitation unit of a university hospital.
SUBJECTS
A total of 62 patients with early-stage CVD were allocated to either an experimental group or a control group.
INTERVENTIONS
Experimental group ( n = 29) received Kinesio Taping intervention once a week for four weeks, while control group ( n = 29) received compression stockings for four weeks. All patients additionally undertook an exercise training programme including calf muscle pump exercises, flexibility exercises and diaphragmatic breathing.
MAIN MEASURES
Visual analogue scale, lower limb circumference measurements, 6-minute walk test and Short Form 36 questionnaire were applied before and after four weeks of treatment.
RESULTS
Control group showed statistically significant improvements in pain ( P < 0.001), ankle circumferences (right, P = 0.002; left, P = 0.037), calf circumferences (right, P = 0.020; left, P = 0.022), knee circumference (left, P = 0.039) and thigh circumferences (right, P = 0.029; left, P = 0.002) compared with experimental group. There were no significant differences between groups with respect to functional capacity and quality of life ( P > 0.05). Both groups significantly improved 6-minute walk distance ( P < 0.001) and Short Form 36 physical component summary (experimental group, P = 0.002; control group, P = 0.006).
CONCLUSION
This study demonstrated that Kinesio Taping and compression stockings revealed similar improvements of functional capacity and quality of life in patients with CVD. The symptoms of pain and edema caused by CVD can be decreased more efficiently with compression stockings than Kinesio Taping intervention.",2020,There were no significant differences between groups with respect to functional capacity and quality of life ( P > 0.05).,"['The study was conducted in a physiotherapy and rehabilitation unit of a university hospital', 'patients with chronic venous disease (CVD', 'patients with CVD', '62 patients with early-stage CVD', 'patients with chronic venous disease']","['exercise training programme including calf muscle pump exercises, flexibility exercises and diaphragmatic breathing', 'control group', 'compression stockings', 'Kinesio Taping intervention', 'Kinesio Taping and compression stockings']","['knee circumference', 'calf circumferences', 'pain, edema, functional capacity and quality of life', '6-minute walk distance', 'symptoms of pain and edema', 'ankle circumferences', 'Visual analogue scale, lower limb circumference measurements, 6-minute walk test and Short Form 36 questionnaire', 'thigh circumferences', 'functional capacity and quality of life', 'pain']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1446279', 'cui_str': 'Lower limb circumference'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}]",62.0,0.0375855,There were no significant differences between groups with respect to functional capacity and quality of life ( P > 0.05).,"[{'ForeName': 'Baha', 'Initials': 'B', 'LastName': 'Naci', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Semiramis', 'Initials': 'S', 'LastName': 'Ozyilmaz', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Nadir', 'Initials': 'N', 'LastName': 'Aygutalp', 'Affiliation': 'Department of Cardiovascular Surgery, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Demir', 'Affiliation': 'Department of Cardiology, Institute of Cardiology, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Gul', 'Initials': 'G', 'LastName': 'Baltaci', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Ankara Guven Hospital, Ankara, Turkey.'}, {'ForeName': 'Zerrin', 'Initials': 'Z', 'LastName': 'Yigit', 'Affiliation': 'Department of Cardiology, Institute of Cardiology, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]",Clinical rehabilitation,['10.1177/0269215520916851']
27,32349543,Effects of a core stabilization training program on balance ability in persons with Parkinson's disease: a randomized controlled trial.,"OBJECTIVE
To explore the effects of an eight-week core stability program on balance ability in persons with Parkinson's disease.
DESIGN
Randomized controlled trial.
SETTING
A local Parkinson's association.
SUBJECTS
A total of 44 participants with a clinical diagnosis of Parkinson's disease were randomly assigned to an experimental ( n = 22) or control group ( n = 22).
INTERVENTION
The experimental group received 24 sessions of core training, while the control group received an intervention including active joint mobilization, muscle stretching, and motor coordination exercises.
MAIN MEASURES
The primary outcome measure was dynamic balance evaluated using the Mini-Balance Evaluation Systems Test. Secondary outcomes included the balance confidence assessed with the Activities-specific Balance Confidence Scale and standing balance assessed by the maximal excursion of center of pressure during the Modified Clinical Test of Sensory Interaction on Balance and the Limits of Stability test.
RESULTS
After treatment, a significant between-group improvement in dynamic balance was observed in the experimental group compared to the control group (change, 2.75 ± 1.80 vs 0.38 ± 2.15, P = 0.002). The experimental group also showed a significant improvement in confidence (change, 16.48 ± 16.21 vs 3.05 ± 13.53, P = 0.047) and maximal excursion of center of pressure in forward (change, 0.86 ± 1.89 cm vs 0.17 ± 0.26 cm, P = 0.048), left (change, 0.88 ± 2.63 cm vs 0.07 ± 0.48 cm, P = 0.010), and right (change, 1.63 ± 2.82 cm vs 0.05 ± 0.17 cm, P = 0.046) directions of limits of stability compared to the control group.
CONCLUSION
A program based on core stability in comparison with non-specific exercise benefits dynamic balance and confidence and increases center of mass excursion in patients with Parkinson's disease.",2020,"After treatment, a significant between-group improvement in dynamic balance was observed in the experimental group compared to the control group (change, 2.75 ± 1.80 vs 0.38 ± 2.15, P = 0.002).","[""patients with Parkinson's disease"", ""44 participants with a clinical diagnosis of Parkinson's disease"", ""persons with Parkinson's disease""]","['core stabilization training program', 'eight-week core stability program', '24 sessions of core training, while the control group received an intervention including active joint mobilization, muscle stretching, and motor coordination exercises']","['maximal excursion of center of pressure', 'balance confidence assessed with the Activities-specific Balance Confidence Scale and standing balance assessed by the maximal excursion of center of pressure during the Modified Clinical Test of Sensory Interaction on Balance and the Limits of Stability test', 'balance ability', 'dynamic balance evaluated using the Mini-Balance Evaluation Systems Test', 'confidence', 'dynamic balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}, {'cui': 'C0203990', 'cui_str': 'Coordination exercise'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",44.0,0.0529084,"After treatment, a significant between-group improvement in dynamic balance was observed in the experimental group compared to the control group (change, 2.75 ± 1.80 vs 0.38 ± 2.15, P = 0.002).","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cabrera-Martos', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Ana Teresa', 'Initials': 'AT', 'LastName': 'Jiménez-Martín', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rodríguez-Torres', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Ortiz-Rubio', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Marie Carmen', 'Initials': 'MC', 'LastName': 'Valenza', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}]",Clinical rehabilitation,['10.1177/0269215520918631']
28,32353544,Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.,"Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.",2020,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","['expectant mothers (MOMs', 'Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30\u202fweeks, recruited from 12 sites', 'pregnant women with OUD treated with BUP-XR, relative to BUP-SL', 'pregnant women']","['sublingual (SL) buprenorphine (BUP', 'buprenorphine formulations', 'prenatal exposure to BUP-XR versus BUP-SL']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],300.0,0.0591114,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lofwall', 'Affiliation': 'Departments of Behavioral Science and Psychiatry, University of Kentucky College of Medicine, Center on Drug and Alcohol Research, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, 410 North Greensboro St., Carrboro, NC 27510, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Davida M', 'Initials': 'DM', 'LastName': 'Schiff', 'Affiliation': 'Division of General Academic Pediatrics, MassGeneral Hospital for Children, 125 Nashua St Suite 860, Boston, MA 02114, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wexelblatt', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, 425 East 61st Street Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': ""Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Division of Alcohol, Drug and Addictions and the Division of Women's Mental Health, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA.""}, {'ForeName': 'Mishka', 'Initials': 'M', 'LastName': 'Terplan', 'Affiliation': 'Friends Research Institute,1040 Park Ave Suite 103, Baltimore, MD 21201, USA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Medical University of South Carolina, 67 President St., MSC 861, Charleston, SC 29425, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Blvd, Bethesda, MD 20892, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106014']
29,32344176,Imagining a positive future reduces cortisol response to awakening and reactivity to acute stress.,"The positive influence of optimism on health is thought to be due in part to a reduced physiological response to stress, as manifested for instance in activity of hypothalamic-pituitary-adrenal (HPA) systems. Results of previous studies support the notion that dispositional optimism can influence diurnal cortisol secretion as well as cortisol reactivity. The aim of the present study was to examine whether induced optimism can similarly affect HPA activity and thereby potentially have beneficial health effects. We assigned 66 university students to either the Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises. Before and after the intervention, we assessed diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal. Effects of the BPS intervention were tested with repeated measures ANOVA (psychological outcomes) and multilevel regression (cortisol outcomes). The BPS intervention was associated with decreases in both the CAR and cortisol responses to acute stress. Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism. Within-person decreases in worrying were associated with decreased CARs, whereas both decreased worrying and increased PA were linked to attenuated stress reactivity. Results suggest that the BPS intervention can influence HPA axis reactivity, with effects on well-being variables likely mediating the process. More research is needed to determine longer-term neuroendocrine and health effects of such interventions in at-risk as well as healthy populations.",2020,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.",['66 university students to either the'],"['BPS intervention', 'Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises']","['optimism', 'CAR and cortisol responses', 'cortisol response', 'diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal', 'HPA axis reactivity', 'HPA activity', 'diurnal cortisol secretion']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",66.0,0.0181314,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.","[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Nicolson', 'Affiliation': 'Department of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: n.nicolson@maastrichtuniversity.nl.'}, {'ForeName': 'Madelon L', 'Initials': 'ML', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: madelon.peters@maastrichtuniversity.nl.'}, {'ForeName': 'Yvo M C', 'Initials': 'YMC', 'LastName': 'In den Bosch-Meevissen', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104677']
30,32351642,Socially-Assistive Robots Using Empathy to Reduce Pain and Distress during Peripheral IV Placement in Children.,"Objectives
Socially-assistive robots (SAR) have been used to reduce pain and distress in children in medical settings. Patients who perceive empathic treatment have increased satisfaction and improved outcomes. We sought to determine if an empathic SAR could be developed and used to decrease pain and fear associated with peripheral IV placement in children.
Methods
We conducted a pilot study of children receiving IV placement. Participating children were randomized to interact with (1) no robot, or a commercially available 3D printed humanoid SAR robot programmed with (2) empathy or (3) distraction conditions. Children and parents completed demographic surveys, and children used an adapted validated questionnaire to rate the robot's empathy on an 8-point Likert scale. Survey scores were compared by the t -test or chi-square test. Pain and fear were measured by self-report using the FACES and FEAR scales, and video tapes were coded using the CHEOPS and FLACC. Scores were compared using repeated measures 2-way ANOVA. This trial is registered with NCT02840942.
Results
Thirty-one children with an average age of 9.6 years completed the study. For all measures, mean pain and fear scores were lowest in the empathy group immediately before and after IV placement. Children were more likely to attribute characteristics of empathy to the empathic condition (Likert score 7.24 v . 4.70; p =0.012) and to report that having the empathic vs. distraction robot made the IV hurt less (7.45 vs. 4.88; p =0.026).
Conclusions
Children were able to identify SAR designed to display empathic characteristics and reported it helped with IV insertion pain and fear. Mean scores of self-reported or objective pain and fear scales were the lowest in the empathy group and the highest in the distraction condition before and after IV insertion. This result suggests empathy improves SAR functionality when used for painful medical procedures and informs future research into SAR for pain management.",2020,This result suggests empathy improves SAR functionality when used for painful medical procedures and informs future research into SAR for pain management.,"['children in medical settings', 'children', 'children receiving IV placement', 'Thirty-one children with an average age of 9.6 years completed the study', 'Children', 'Participating children']","['interact with (1) no robot, or a commercially available 3D printed humanoid SAR robot programmed with (2) empathy or (3) distraction conditions', 'Socially-assistive robots (SAR']","['pain and fear', 'Pain and fear', 'Mean scores of self-reported or objective pain and fear scales', 'pain and distress', 'FACES and FEAR scales, and video tapes', 'Pain and Distress', 'mean pain and fear scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",31.0,0.0401498,This result suggests empathy improves SAR functionality when used for painful medical procedures and informs future research into SAR for pain management.,"[{'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Trost', 'Affiliation': 'Keck School of Medicine, University of Southern California, Department of Pediatrics, Los Angeles, CA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chrysilla', 'Affiliation': 'The Boeing Company, Chicago, IL, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Gold', 'Affiliation': 'Keck School of Medicine, University of Southern California, Department of Pediatrics, Los Angeles, CA, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Matarić', 'Affiliation': 'University of Southern California, Viterbi School of Engineering, Los Angeles, CA, USA.'}]",Pain research & management,['10.1155/2020/7935215']
31,32353115,ACTH Infusion Impairs Baroreflex Sensitivity-Implications for Cardiovascular Hypoglycemia-Associated Autonomic Failure.,"CONTEXT
Hypoglycemia attenuates cardiovascular homeostatic autonomic control. This attenuation, known as the cardiovascular component of hypoglycemia-associated autonomic failure (HAAF), is characterized most notably by decreased baroreflex sensitivity (BRS) that begins during hypoglycemia and persists until at least the next day, despite return to euglycemia. Understanding the mechanisms underlying this reduction in BRS is important because BRS attenuation is associated with increased morbidity and mortality.
OBJECTIVE
The objective of this work is to investigate the role of the adrenocorticotropin (ACTH)-adrenal axis in decreasing BRS. We tested the hypothesis that infusion of ACTH 1-24 (cosyntropin), as compared to placebo, would acutely suppress BRS, and that this decrease in BRS would be present the next day.
DESIGN
A double-blind, placebo-controlled, random-order, cross-over study was conducted.
SETTING
This study took place in a clinical research center.
PARTICIPANTS
Participants included healthy men and women.
INTERVENTIONS
Interventions included an intravenous infusion of cosyntropin (70 μg/hour for 2.5 hours in the morning and again in the early afternoon) vs normal saline placebo.
MAIN OUTCOME MEASURES
Outcome measures included BRS during and 16 hours after cosyntropin vs placebo infusions.
RESULTS
Cosyntropin infusion attenuated BRS (mm Hg/ms) as compared to placebo (baseline 17.8 ± 1.38 vs 17.0 ± 2.07; during 14.4 ± 1.43 vs 17.3 ± 1.65; and next day 14.8 ± 1.42 vs 18.9 ± 2.04; P < .05, time by treatment, analysis of variance). BRS was decreased during the final 30 minutes of the morning cosyntropin infusion as compared to baseline (P < .01) and remained suppressed the next day (16 hours after afternoon infusion) (P < .025). Placebo infusion did not significantly change BRS. Corrected QT interval was not affected.
CONCLUSIONS
ACTH attenuates BRS, raising the possibility that hypoglycemia-induced increases in ACTH may contribute to the cardiovascular component of HAAF.",2020,"QTc was not affected.
",['Healthy men and women'],"['normal saline placebo', 'Placebo', 'ACTH Infusion', 'cosyntropin', 'adrenocorticotropin hormone (ACTH)-adrenal axis', 'placebo']","['change BRS', 'BRS', 'QTc', 'baroreflex sensitivity (BRS']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0199780', 'cui_str': 'Administration of hormone'}, {'cui': 'C0010192', 'cui_str': 'Cosyntropin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",,0.120712,"QTc was not affected.
","[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Leung', 'Affiliation': 'Division of Endocrinology and Diabetes, Virginia Mason Medical Center, Seattle, Washington.'}, {'ForeName': 'Omar F', 'Initials': 'OF', 'LastName': 'Bayomy', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bonyhay', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Celli', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gail K', 'Initials': 'GK', 'LastName': 'Adler', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa221']
32,32353816,Effects of a Mindfulness-based Intervention on diurnal cortisol pattern in disadvantaged families: A randomized controlled trial.,"OBJECTIVE
The present study examined the psychophysiological effects of Family-based Mindfulness Intervention (FBMI) on children and parents from disadvantaged families.
METHODS
This randomized controlled trial recruited parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n = 26) and waitlist control (n = 25) groups. The parent intervention included 6 sessions and the child intervention included 8 sessions with 2 half-hour joint programs. Both interventions lasted 9 hours in total each. All participants completed four salivary cortisol measures after wakeup, before lunchtime, late-afternoon, and before sleep at baseline and end of the intervention. The diurnal cortisol pattern was summarized by the morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope.
RESULTS
Compared to the control group, children in the FBMI group showed significant increases in morning cortisol (d = 0.50, p = 0.03) and significant decreases in diurnal cortisol slopes (d = 0.50, p = 0.04) at the end of intervention. Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p = 0.04) compared to the control group at the end of intervention. No significant treatment effects were found on the mean cortisol.
DISCUSSION
The present findings suggest that FBMI could improve the diurnal cortisol slope and cortisol levels of the children and parents from disadvantaged families, respectively. Future studies should elucidate its potential benefits on neuroendocrine functioning.",2020,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p = 0.04) compared to the control group at the end of intervention.","['children and parents from disadvantaged families', 'parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n\u202f=\u202f26) and waitlist control (n\u202f=\u202f25) groups', 'disadvantaged families']","['Mindfulness-based Intervention', 'FBMI', 'Family-based Mindfulness Intervention (FBMI', 'child intervention included 8 sessions with 2 half-hour joint programs']","['morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope', 'diurnal cortisol slopes', 'morning cortisol', 'evening cortisol', 'diurnal cortisol slope and cortisol levels', 'salivary cortisol measures', 'mean cortisol', 'diurnal cortisol pattern']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",51.0,0.0257721,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p = 0.04) compared to the control group at the end of intervention.","[{'ForeName': 'Rainbow T H', 'Initials': 'RTH', 'LastName': 'Ho', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Herman H M', 'Initials': 'HHM', 'LastName': 'Lo', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: herman.lo@polyu.edu.hk.'}, {'ForeName': 'Ted C T', 'Initials': 'TCT', 'LastName': 'Fong', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Choi', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104696']
33,32353822,Effects of sugammadex on postoperative respiratory management in children with congenital heart disease: a randomized controlled study.,"BACKGROUND
Early extubation can reduce pulmonary complications in children undergoing cardiac surgery. The aim of this study is to evaluate the effects of sugammadex for postoperative respiratory management in children with congenital heart disease.
METHODS
Sixty children with congenital heart disease undergoing elective cardiac surgery were divided into group S and group C (30 children in each group). When post tetanic twitches count (PTC) = 1-2 and train-of-four (TOF) = 0, the children in group S received sugammadex4 mg/kg for reversal of neuromuscular block at the end of surgery, and the children in group C received the same volume of normal saline. The recovery time to TOF of 0.9, the mechanical ventilation and extubation times were recorded. On the other side, the hemodynamic parameters before and 5 min after administration, and side effects were also recorded. The levels of C-reactive protein (CRP) and procalcitonin (PCT) before and 24 h after surgery were measured.
RESULTS
The recovery time to TOF of 0.9 and extubation time were significantly shorter in the group S than in the group C (4.2 ± 1.4 vs 108.2 ± 26.7 min, 66.3 ± 6.5 vs 171.6 ± 23.1 min, respectively, P < 0.01). The CRP and PCT levels were found to be increased in both groups at postoperative 24 h than before surgery. Further, the levels of PCT and CRP at postoperative 24 h were lower in group S when compared to group C (median, 7 vs 17.5 mg/ml, 1.76 vs 5.22 ng/ml, respectively, P < 0.05). There were no statistical differences observed between the two groups (P> 0.05) with respect to side effects.
CONCLUSION
Sugammadex is rapid and effective in reversing rocuronium-induced neuromuscular block, and significantly reduces the extubation time and the release of postoperative CRP and PCT in children with congenital heart diseases.",2020,"The levels of C-reactive protein (CRP) and procalcitonin (PCT) before and 24 h after surgery were measured.
","['children undergoing cardiac surgery', 'children with congenital heart diseases', 'Sixty children with congenital heart disease undergoing elective cardiac surgery', 'children with congenital heart disease']","['sugammadex', 'Sugammadex']","['levels of PCT and CRP', 'postoperative respiratory management', 'levels of C-reactive protein (CRP) and procalcitonin (PCT', 'CRP and PCT levels', 'pulmonary complications', 'extubation time', 'recovery time to TOF of 0.9 and extubation time', 'recovery time to TOF of 0.9, the mechanical ventilation and extubation times']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",60.0,0.104172,"The levels of C-reactive protein (CRP) and procalcitonin (PCT) before and 24 h after surgery were measured.
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiaobing', 'Affiliation': ""Department of Cardiothoracic Surgery, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Anesthesiology, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Wangping', 'Affiliation': ""Department of Anesthesiology, Women and Children's Hospital of Jiaxing University, Jiaxing 314000, China. Electronic address: zhang650679@163.com.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Rufang', 'Affiliation': ""Department of Cardiothoracic Surgery, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China. Electronic address: zhangrf398@163.com.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': ""Department of Cardiothoracic Surgery, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Rong', 'Affiliation': ""Department of Anesthesiology, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110180']
34,32353830,Implications of maraviroc and/or rapamycin in a mouse model of fragility.,"BACKGROUND
As age increases, the risk of developing fragility also increases. Improving the knowledge of frailty could contribute to maintaining the functional ability of elderly people. Interleukin (IL)-10 homozygous knockout mice (IL-10 tm/tm [IL10KO]) constitute an excellent tool for the study of frailty. Because patients with frailty demonstrate an overexpression of CCR5, rapamycin (RAPA) and/or maraviroc (MVC), two molecules able to decrease CCR5 expression, were evaluated.
RESULTS
Muscle myostatin was reduced in all the therapeutic groups but the MVC group (p <0.001 for RAPA and MVC-RAPA) and in serum samples (p <0.01 for all the groups). Serum CK levels were also significantly lower in MVC and RAPA groups (p <0.01 in both cases). Lower AST levels were observed in all the therapeutic groups (p <0.05 for all of them). The apoptotic effector caspase-3 was significantly lower in MVC and RAPA groups (p<0.05 in both cases). Combined treatment with MVC-RAPA showed a synergistic increase in p-AKT, p-mTOR and SIRT1 levels.
CONCLUSIONS
MVC and RAPA show a protective role in some factors involved in frailty. More studies are needed to prove their clinical applications.
MATERIAL AND METHODS
Eighty male homozygous IL10KOs were randomly assigned to one of 4 groups (n= 20): i) IL10KO group (IL10KO); ii) IL10KO receiving MVC in drinking water (MVC group), iii) IL10KO receiving RAPA in drinking water (RAPA group), and finally, iv) MVC-RAPA group that received MVC and RAPA in drinking water. Blood and muscle samples were analysed. Survival analysis, frailty index calculation, and functional assessment were also performed.",2020,"Combined treatment with MVC-RAPA showed a synergistic increase in p-AKT, p-mTOR and SIRT1 levels.
",['Eighty male homozygous IL10KOs'],"['Interleukin (IL)-10 homozygous knockout mice (IL-10 tm/tm [IL10KO', 'maraviroc and/or rapamycin', 'MVC-RAPA', 'IL10KO group (IL10KO); ii) IL10KO receiving MVC in drinking water (MVC group), iii) IL10KO receiving RAPA in drinking water (RAPA group), and finally, iv) MVC-RAPA group that received MVC and RAPA in drinking water']","['Muscle myostatin', 'apoptotic effector caspase-3', 'Serum CK levels', 'Survival analysis, frailty index calculation, and functional assessment', 'Lower AST levels', 'synergistic increase in p-AKT, p-mTOR and SIRT1 levels', 'overexpression of CCR5, rapamycin (RAPA) and/or maraviroc (MVC']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0206745', 'cui_str': 'Mouse, Knockout'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C1720985', 'cui_str': 'Effector Caspases'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C3711103', 'cui_str': 'CCR5 protein, human'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}]",80.0,0.0189046,"Combined treatment with MVC-RAPA showed a synergistic increase in p-AKT, p-mTOR and SIRT1 levels.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pérez-Martínez', 'Affiliation': 'Centro de Investigación Biomédica de La Rioja (CIBIR), Logroño, España.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Romero', 'Affiliation': 'Centro de Investigación Biomédica de La Rioja (CIBIR), Logroño, España.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Muñoz-Galván', 'Affiliation': 'Instituto de Biomedicina de Sevilla, IBIS, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Consejo Superior de Investigaciones Científicas, Sevilla, España.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Verdugo-Sivianes', 'Affiliation': 'Instituto de Biomedicina de Sevilla, IBIS, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Consejo Superior de Investigaciones Científicas, Sevilla, España.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Rubio-Mediavilla', 'Affiliation': 'Servicio de Anatomía Patológica, Hospital San Pedro, Logroño, España.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Oteo', 'Affiliation': 'Centro de Investigación Biomédica de La Rioja (CIBIR), Logroño, España.'}, {'ForeName': 'Amancio', 'Initials': 'A', 'LastName': 'Carnero', 'Affiliation': 'Instituto de Biomedicina de Sevilla, IBIS, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Consejo Superior de Investigaciones Científicas, Sevilla, España.'}, {'ForeName': 'José-Ramón', 'Initials': 'JR', 'LastName': 'Blanco', 'Affiliation': 'Centro de Investigación Biomédica de La Rioja (CIBIR), Logroño, España.'}]",Aging,['10.18632/aging.103167']
35,32356609,Phosphodiesterase-4 inhibitors for chronic obstructive pulmonary disease.,"BACKGROUND
Chronic obstructive pulmonary disease (COPD) is associated with cough, sputum production or dyspnoea, and a reduction in lung function, quality of life, and life expectancy. Apart from smoking cessation, no other treatments that slow lung function decline are available. Roflumilast and cilomilast are oral phosphodiesterase-4 (PDE₄) inhibitors proposed to reduce the airway inflammation and bronchoconstriction seen in COPD. This Cochrane Review was first published in 2011, and was updated in 2017 and 2020.
OBJECTIVES
To evaluate the efficacy and safety of oral PDE₄ inhibitors for management of stable COPD.
SEARCH METHODS
We identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register (date of last search 9 March 2020). We found other trials at web-based clinical trials registers.
SELECTION CRITERIA
We included RCTs if they compared oral PDE₄ inhibitors with placebo in people with COPD. We allowed co-administration of standard COPD therapy.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Two independent review authors selected trials for inclusion, extracted data, and assessed risk of bias. We resolved discrepancies by involving a third review author. We assessed our confidence in the evidence by using GRADE recommendations. Primary outcomes were change in lung function (minimally important difference (MID) = 100 mL) and quality of life (scale 0 to 100; higher score indicates more limitations).
MAIN RESULTS
We found 42 RCTs that met the inclusion criteria and were included in the analyses for roflumilast (28 trials with 18,046 participants) or cilomilast (14 trials with 6457 participants) or tetomilast (1 trial with 84 participants), with a duration between six weeks and one year or longer. These trials included people across international study centres with moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grades II to IV), with mean age of 64 years. We judged risks of selection bias, performance bias, and attrition bias as low overall amongst the 39 published and unpublished trials. Lung function Treatment with a PDE₄ inhibitor was associated with a small, clinically insignificant improvement in forced expiratory volume in one second (FEV₁) over a mean of 40 weeks compared with placebo (mean difference (MD) 49.33 mL, 95% confidence interval (CI) 44.17 to 54.49; participants = 20,815; studies = 29; moderate-certainty evidence). Forced vital capacity (FVC) and peak expiratory flow (PEF) were also improved over 40 weeks (FVC: MD 86.98 mL, 95% CI 74.65 to 99.31; participants = 22,108; studies = 17; high-certainty evidence; PEF: MD 6.54 L/min, 95% CI 3.95 to 9.13; participants = 4245; studies = 6; low-certainty evidence). Quality of life Trials reported improvements in quality of life over a mean of 33 weeks (St George's Respiratory Questionnaire (SGRQ) MD -1.06 units, 95% CI -1.68 to -0.43; participants = 7645 ; moderate-certainty evidence). Incidence of exacerbations Treatment with a PDE₄ inhibitor was associated with a reduced likelihood of COPD exacerbation over a mean of 40 weeks (odds ratio (OR) 0.78, 95% CI 0.73 to 0.84; participants = 20,382; studies = 27; high-certainty evidence), that is, for every 100 people treated with PDE₄ inhibitors, five more remained exacerbation-free during the study period compared with those given placebo (number needed to treat for an additional beneficial outcome (NNTB) 20, 95% CI 16 to 27). No change in COPD-related symptoms nor in exercise tolerance was found. Adverse events More participants in the treatment groups experienced an adverse effect compared with control participants over a mean of 39 weeks (OR 1.30, 95% CI 1.22 to 1.38; participants = 21,310; studies = 30; low-certainty evidence). Participants experienced a range of gastrointestinal symptoms such as diarrhoea, nausea, vomiting, or dyspepsia. Diarrhoea was more commonly reported with PDE₄ inhibitor treatment (OR 3.20, 95% CI 2.74 to 3.50; participants = 20,623; studies = 29; high-certainty evidence), that is, for every 100 people treated with PDE₄ inhibitors, seven more suffered from diarrhoea during the study period compared with those given placebo (number needed to treat for an additional harmful outcome (NNTH) 15, 95% CI 13 to 17). The likelihood of psychiatric adverse events was higher with roflumilast 500 µg than with placebo (OR 2.13, 95% CI 1.79 to 2.54; participants = 11,168; studies = 15 (COPD pool data); moderate-certainty evidence). Roflumilast in particular was associated with weight loss during the trial period and with an increase in insomnia and depressive mood symptoms. Participants treated with PDE₄ inhibitors were more likely to withdraw from trial participation; on average, 14% in the treatment groups withdrew compared with 8% in the control groups. Mortality No effect on mortality was found (OR 0.98, 95% CI 0.77 to 1.24; participants = 19,786; studies = 27; moderate-certainty evidence), although mortality was a rare event during these trials.
AUTHORS' CONCLUSIONS
For this current update, five new studies from the 2020 search contributed to existing findings but made little impact on outcomes described in earlier versions of this review. PDE₄ inhibitors offered a small benefit over placebo in improving lung function and reducing the likelihood of exacerbations in people with COPD; however, they had little impact on quality of life or on symptoms. Gastrointestinal adverse effects and weight loss were common, and the likelihood of psychiatric symptoms was higher, with roflumilast 500 µg. The findings of this review provide cautious support for the use of PDE₄ inhibitors in COPD. In accordance with GOLD 2020 guidelines, they may have a place as add-on therapy for a subgroup of people with persistent symptoms or exacerbations despite optimal COPD management (e.g. people whose condition is not controlled by fixed-dose long-acting beta₂-agonist (LABA) and inhaled corticosteroid (ICS) combinations). More longer-term trials are needed to determine whether or not PDE₄ inhibitors modify FEV₁ decline, hospitalisation, or mortality in COPD.",2020,"Lung function Treatment with a PDE₄ inhibitor was associated with a small, clinically insignificant improvement in forced expiratory volume in one second (FEV₁) over a mean of 40 weeks compared with placebo (mean difference (MD) 49.33 mL, 95% confidence interval (CI) 44.17 to 54.49; participants = 20,815; studies = 29; moderate-certainty evidence).","['Chronic obstructive pulmonary disease (COPD', 'chronic obstructive pulmonary disease', 'people with COPD', '42 RCTs that met the inclusion criteria and were included in the analyses for roflumilast (28 trials with 18,046 participants) or cilomilast (14 trials with 6457 participants) or tetomilast (1 trial with 84 participants), with a duration between six weeks and one year or longer', 'people across international study centres with moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grades II to IV), with mean age of 64 years']","['Roflumilast and cilomilast', 'Phosphodiesterase-4 inhibitors', 'phosphodiesterase-4 (PDE₄) inhibitors', 'Roflumilast', 'standard COPD therapy', 'PDE₄ inhibitor', 'PDE₄ inhibitors', 'oral PDE₄ inhibitors', 'placebo']","['quality of life', 'likelihood of psychiatric adverse events', 'Diarrhoea', 'forced expiratory volume', 'Adverse events', 'Forced vital capacity (FVC) and peak expiratory flow (PEF', 'lung function', 'efficacy and safety', 'weight loss', 'change in lung function (minimally important difference (MID) = 100 mL) and quality of life', 'range of gastrointestinal symptoms such as diarrhoea, nausea, vomiting, or dyspepsia', 'Mortality', 'COPD exacerbation', 'mortality', 'Gastrointestinal adverse effects and weight loss', 'insomnia and depressive mood symptoms', 'adverse effect', 'likelihood of psychiatric symptoms']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C0968887', 'cui_str': 'Cilomilast'}, {'cui': 'C1876228', 'cui_str': 'tetomilast'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C0968887', 'cui_str': 'Cilomilast'}, {'cui': 'C2936609', 'cui_str': 'Phosphodiesterase 4 inhibitor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]",84.0,0.731139,"Lung function Treatment with a PDE₄ inhibitor was associated with a small, clinically insignificant improvement in forced expiratory volume in one second (FEV₁) over a mean of 40 weeks compared with placebo (mean difference (MD) 49.33 mL, 95% confidence interval (CI) 44.17 to 54.49; participants = 20,815; studies = 29; moderate-certainty evidence).","[{'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Janjua', 'Affiliation': ""Cochrane Airways, Population Health Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Fortescue', 'Affiliation': ""Cochrane Airways, Population Health Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Phillippa', 'Initials': 'P', 'LastName': 'Poole', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD002309.pub6']
36,32369036,Cost-Effectiveness of Virtual Reality Cognitive Behavioral Therapy for Psychosis: Health-Economic Evaluation Within a Randomized Controlled Trial.,"BACKGROUND
Evidence was found for the effectiveness of virtual reality-based cognitive behavioral therapy (VR-CBT) for treating paranoia in psychosis, but health-economic evaluations are lacking.
OBJECTIVE
This study aimed to determine the short-term cost-effectiveness of VR-CBT.
METHODS
The health-economic evaluation was embedded in a randomized controlled trial evaluating VR-CBT in 116 patients with a psychotic disorder suffering from paranoid ideation. The control group (n=58) received treatment as usual (TAU) for psychotic disorders in accordance with the clinical guidelines. The experimental group (n=58) received TAU complemented with add-on VR-CBT to reduce paranoid ideation and social avoidance. Data were collected at baseline and at 3 and 6 months postbaseline. Treatment response was defined as a pre-post improvement of symptoms of at least 20% in social participation measures. Change in quality-adjusted life years (QALYs) was estimated by using Sanderson et al's conversion factor to map a change in the standardized mean difference of Green's Paranoid Thoughts Scale score on a corresponding change in utility. The incremental cost-effectiveness ratios were calculated using 5000 bootstraps of seemingly unrelated regression equations of costs and effects. The cost-effectiveness acceptability curves were graphed for the costs per treatment responder gained and per QALY gained.
RESULTS
The average mean incremental costs for a treatment responder on social participation ranged between €8079 and €19,525, with 90.74%-99.74% showing improvement. The average incremental cost per QALY was €48,868 over the 6 months of follow-up, with 99.98% showing improved QALYs. Sensitivity analyses show costs to be lower when relevant baseline differences were included in the analysis. Average costs per treatment responder now ranged between €6800 and €16,597, while the average cost per QALY gained was €42,030.
CONCLUSIONS
This study demonstrates that offering VR-CBT to patients with paranoid delusions is an economically viable approach toward improving patients' health in a cost-effective manner. Long-term effects need further research.
TRIAL REGISTRATION
International Standard Randomised Controlled Trial Number (ISRCTN) 12929657; http://www.isrctn.com/ISRCTN12929657.",2020,"The average mean incremental costs for a treatment responder on social participation ranged between €8079 and €19,525, with 90.74%-99.74% showing improvement.","['patients with paranoid delusions', '116 patients with a psychotic disorder suffering from paranoid ideation', 'Psychosis']","['treatment as usual (TAU', 'TAU complemented with add-on VR-CBT', 'Virtual Reality Cognitive Behavioral Therapy', 'VR-CBT', 'virtual reality-based cognitive behavioral therapy (VR-CBT']","['average incremental cost per QALY', 'Change in quality-adjusted life years (QALYs', ""Green's Paranoid Thoughts Scale score"", 'average mean incremental costs', 'paranoid ideation and social avoidance', 'cost-effectiveness acceptability curves', 'incremental cost-effectiveness ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349398', 'cui_str': 'Paranoid delusion'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0747249', 'cui_str': 'Paranoid ideation'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0747249', 'cui_str': 'Paranoid ideation'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.087761,"The average mean incremental costs for a treatment responder on social participation ranged between €8079 and €19,525, with 90.74%-99.74% showing improvement.","[{'ForeName': 'Roos', 'Initials': 'R', 'LastName': 'Pot-Kolder', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Veling', 'Affiliation': 'Department of Psychiatry, University Medical Centre Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Geraets', 'Affiliation': 'Department of Psychiatry, University Medical Centre Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Lokkerbol', 'Affiliation': 'Centre of Economic Evaluation and Machine Learning, Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Jongeneel', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ising', 'Affiliation': 'Department of Psychosis Research, Parnassia Psychiatric Institute, The Hague, Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/17098']
37,32378724,"A Randomized, Double-blind, Placebo-controlled Clinical Study to Investigate the efficacy of Herring Roe Oil for treatment of Psoriasis.","The effect of omega-3 polyunsaturated fatty acid supplements in patients with psoriasis vulgaris has previously been investigated, but interventions varied in source, composition, dose, administration route and duration of treatment. The observed beneficial effects in patients with psoriasis vulgaris using herring roe oil as a dietary supplement prompted this investigation. This randomised, double-blind and placebo-controlled study was designed and performed to explore the efficacy and safety of herring roe oil supplementation in 64 patients with plaque psoriasis (ClinicalTrials.gov: NCT03359577). The primary end-point was comparing the change in mean Psoriasis Area Severity Index (PASI) scores in the herring roe oil treatment group and the placebo group from baseline to week 26. In the intention-to-treat population, a statistically significant improvement in the mean PASI score was observed with herring roe oil compared to placebo at 26 weeks. In the recruited patient group, the measured improvement was greatest in patients with a PASI score from 5.5-9.9 at baseline.",2020,"In the intention-to-treat population, a statistically significant improvement in the mean PASI score was observed with herring roe oil compared to placebo at 26 weeks.","['patients with Psoriasis vulgaris', '64 patients with plaque psoriasis (ClinicalTrials.gov']","['Placebo', 'herring roe oil supplementation', 'omega-3 polyunsaturated fatty acid supplements', 'Herring Roe Oil', 'placebo']","['efficacy and safety', 'PASI score', 'mean Psoriasis Area Severity Index (PASI) scores', 'mean PASI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1852159', 'cui_str': 'Ridges-off-the-end syndrome'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",64.0,0.388406,"In the intention-to-treat population, a statistically significant improvement in the mean PASI score was observed with herring roe oil compared to placebo at 26 weeks.","[{'ForeName': 'Kåre Steinar', 'Initials': 'KS', 'LastName': 'Tveit', 'Affiliation': 'Department of Dermatology, Haukeland University Hospital, NO-5021 Bergen, Norway. E-mail: kare.steinar.tveit@helse-bergen.no.'}, {'ForeName': 'Karl Albert', 'Initials': 'KA', 'LastName': 'Brokstad', 'Affiliation': ''}, {'ForeName': 'Rolf K', 'Initials': 'RK', 'LastName': 'Berge', 'Affiliation': ''}, {'ForeName': 'Per Christian', 'Initials': 'PC', 'LastName': 'Sæbø', 'Affiliation': ''}, {'ForeName': 'Hogne', 'Initials': 'H', 'LastName': 'Hallaråker', 'Affiliation': ''}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Brekke', 'Affiliation': ''}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Meland', 'Affiliation': ''}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Bjørndal', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3507']
38,32364506,A Persuasive mHealth Behavioral Change Intervention for Promoting Physical Activity in the Workplace: Feasibility Randomized Controlled Trial.,"BACKGROUND
Employees in an office setting are more likely to remain physically inactive. Physical inactivity has become one of the major barriers to overcoming the risk factors for anxiety, depression, coronary heart disease, certain cancers, and type 2 diabetes. Currently, there is a gap in mobile health (mHealth) apps to promote physical activity (PA) for workers in the workplace. Studies on behavior change theories have concluded that health apps generally lack the use of theoretical constructs.
OBJECTIVE
The objective of this study was to study the feasibility of a persuasive app aimed at encouraging PA among employees and to understand the motivational aspects behind the implementation of mHealth apps among office workers.
METHODS
A 4-week study using a mixed methods (quantitative and qualitative) design was conducted with office-based employees in cities in 4 countries: Oulu, Finland; Carlow, Ireland; London, United Kingdom; and Dhaka, Bangladesh. Of the 220 invited participants (experimental group, n=115; control group, n=105), 84 participated (experimental group, n=56; control group, n=28), consisting of working-age volunteers working in an office setting. Participants used 2 different interventions: The experimental group used an mHealth app for PA motivation, and the control group used a paper diary. The purpose was to motivate employees to engage in healthier behavior regarding the promotion of PA in the workplace. A user-centered design process was followed to design, develop, and evaluate the mHealth app, incorporating self-determination theory (SDT) and using game elements. The paper diary had no specific theory-driven approach, design technique, nor game elements.
RESULTS
Compliance with app usage remained relatively low, with 27 participants (experimental group, n=20; control group, n=7) completing the study. The results support the original hypothesis that the mHealth app would help increase PA (ie, promoting daily walking in the workplace) in comparison to a paper diary (P=.033). The mHealth app supported 2 of the basic SDT psychological needs, namely autonomy (P=.004) and competence (P=.014), but not the needs of relatedness (P=.535).
CONCLUSIONS
The SDT-based mHealth application motivated employees to increase their PA in the workplace. However, compliance with app usage remained low. Future research should further develop the app based on user feedback and test it in a larger sample.",2020,"The mHealth app supported 2 of the basic SDT psychological needs, namely autonomy (P=.004) and competence (P=.014), but not the needs of relatedness (P=.535).
","['office-based employees in cities in 4 countries: Oulu, Finland; Carlow, Ireland; London, United Kingdom; and Dhaka, Bangladesh', '27 participants (experimental group, n=20; control group, n=7) completing the study', '220 invited participants (experimental group, n=115; control group, n=105), 84 participated (experimental group, n=56; control group, n=28), consisting of working-age volunteers working in an office setting']","['mHealth app for PA motivation, and the control group used a paper diary', 'mHealth Behavioral Change Intervention']",[],"[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0454771', 'cui_str': 'Carlow'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],220.0,0.0246645,"The mHealth app supported 2 of the basic SDT psychological needs, namely autonomy (P=.004) and competence (P=.014), but not the needs of relatedness (P=.535).
","[{'ForeName': 'Md Sanaul', 'Initials': 'MS', 'LastName': 'Haque', 'Affiliation': 'Research Unit of Medical Imaging Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Kangas', 'Affiliation': 'Research Unit of Medical Imaging Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Jämsä', 'Affiliation': 'Research Unit of Medical Imaging Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland.'}]",JMIR formative research,['10.2196/15083']
39,32366427,Impact of the Lysine-urethane Adhesive TissuGlu® on Postoperative Complications and Interventions After Drain-free Mastectomy.,"BACKGROUND/AIM
The influence of a polyurethane-based tissue adhesive (TissuGlu®) on common complications following breast surgery was investigated.
PATIENTS AND METHODS
Within a Randomized-Controlled-Trial 70 women (n=35 TissuGlu®, n=35 drain) underwent a mastectomy with or without sentinel lymph node excision (SLNE), followed by a 90-day postoperative follow-up.
RESULTS
Postoperative interventions: Non-inferiority of the application of TissuGlu® was seen. Pain-Level/ Hospitalization: A statistically significant pain reduction from day four onwards (p<0.001) and a shorter hospitalization period (p<0.001) was observed. In contrast, the TissuGlu® group showed increased mean puncture incidence (p=0.013), and increased puncture volume (p=0.021).
CONCLUSION
Application of the polyurethane-based tissue adhesive TissuGlu® after mastectomy, with or without SLNE, showed potential for improvement of the clinical outcome. In contrast, high intervention rates and increased puncture volume, caused by recurring seromas following application of the surgical adhesive TissuGlu®, have a negative impact on the patient-specific convalescence.",2020,A statistically significant pain reduction from day four onwards (p<0.001) and a shorter hospitalization period (p<0.001) was observed.,['70 women'],"['mastectomy with or without sentinel lymph node excision (SLNE', 'Drain-free Mastectomy', 'polyurethane-based tissue adhesive (TissuGlu®', 'Lysine-urethane Adhesive TissuGlu®']","['puncture volume', 'mean puncture incidence', 'pain reduction', 'Postoperative Complications and Interventions', 'Pain-Level/ Hospitalization']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0041964', 'cui_str': 'Urethane'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}]","[{'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",70.0,0.0764512,A statistically significant pain reduction from day four onwards (p<0.001) and a shorter hospitalization period (p<0.001) was observed.,"[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Ohlinger', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Rico', 'Initials': 'R', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohlmann', 'Affiliation': 'Department of Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Paepke', 'Affiliation': 'Department of Obstetrics and Gynecology, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Zaher', 'Initials': 'Z', 'LastName': 'Alwafai', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Flieger', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Sylke', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Lenz', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Zygmunt', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Unger', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medicine Greifswald, Greifswald, Germany jk114735@uni-greifswald.de.'}]",Anticancer research,['10.21873/anticanres.14253']
40,32366450,Defecatory Dysfunction After Colon Cancer Resection: The Role of Inferior Mesenteric Artery Tie.,"BACKGROUND
Although oncological results for resection of colon cancer with inferior mesenteric artery (IMA) ligation at its origin (high tie) or immediately below the left colic artery (low tie) are similar, injury of the superior hypogastric plexus may be caused when the IMA is tied at its origin, thus impairing defecatory functions.
AIM
The importance of IMA tie location on defecatory dysfunction in patients undergoing laparoscopic sigmoidal resection without preoperative radiation therapy was studied.
PATIENTS AND METHODS
From February 2013 to December 2018, 56 consecutive patients submitted to curative laparoscopic resection for stage II and III, M0, sigmoidal cancer were randomized to a high or low tie of the IMA. All demographic data and information on symptoms and comorbidity, intra- and post-operative outcomes and defecatory function before and after surgery [according to the following scales: Fecal Incontinence Quality of Life (FIQL) scale, Jorge-Wexner incontinence and Agachan-Wexner constipation scores] were collected into a computerized database.
RESULTS
All patients completed the questionnaires. The educational and social status, and lifestyle habits (defined as active or sedentary) of our groups were similar. A significant difference in total score of FIQL scale was observed between the high and low tie groups at 1 month [88±6 and 93±7, p=0.005, confidence interval for the difference between mean values (CI Δ )=1.706-9.065] and 6 months (93±7 and 97±6, p=0.030, CI Δ =0.390-7.547). The Jorge-Wexner incontinence scores showed a significant decrease in patients of the high group (1 month: 0.59±0.76 and 6 months: 0.62±0.79, respectively) when compared to those of the low tie group (1 month 0.17±0.38 and 6 months 0.17±0.38, respectively) (p=0.008 and p=0.006 at 1 and 6 months, respectively). At 1, 6 and 12 months, the overall Agachan-Wexner constipation scores were significantly higher in patients of the high tie group when compared to those of the low tie group (1 month: 5.1±1.1 and 4.3±0.86, p=0.002, CI Δ =-1.350--0.316; 6 months: 7.4±1.4 and 6.2±1.4, p=0.003, CI Δ =-1.959--0.436; and 12 months: 7.2±1.3 and 6±1.1, p=0.001, CI Δ =-1.840--0.576, respectively).
CONCLUSION
Patients affected with stage II and III sigmoidal cancer had a better fecal continence at the short- to medium-term and less abdominal pain in the medium- to long-term when a low tie technique was utilized.",2020,"The Jorge-Wexner incontinence scores showed a significant decrease in patients of the high group (1 month: 0.59±0.76 and 6 months: 0.62±0.79, respectively) when compared to those of the low tie group (1 month 0.17±0.38 and 6 months 0.17±0.38, respectively)","['After Colon Cancer Resection', 'From February 2013 to December 2018', '56 consecutive patients submitted to curative laparoscopic resection for stage II and III, M0, sigmoidal cancer', 'patients undergoing laparoscopic sigmoidal resection without preoperative radiation therapy was studied']",['IMA tie location'],"['Jorge-Wexner incontinence scores', 'overall Agachan-Wexner constipation scores', 'Fecal Incontinence Quality of Life (FIQL) scale, Jorge-Wexner incontinence and Agachan-Wexner constipation scores', 'Defecatory Dysfunction', 'fecal continence', 'abdominal pain', 'educational and social status, and lifestyle habits', 'total score of FIQL scale']","[{'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162860', 'cui_str': 'Structure of inferior mesenteric artery'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0450429', 'cui_str': 'Location'}]","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",56.0,0.0269363,"The Jorge-Wexner incontinence scores showed a significant decrease in patients of the high group (1 month: 0.59±0.76 and 6 months: 0.62±0.79, respectively) when compared to those of the low tie group (1 month 0.17±0.38 and 6 months 0.17±0.38, respectively)","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fiori', 'Affiliation': 'Department of Surgery Pietro Valdoni, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Crocetti', 'Affiliation': 'Department of Surgery Pietro Valdoni, Sapienza University of Rome, Rome, Italy danielecrocetti@hotmail.it.'}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'Lamazza', 'Affiliation': 'Department of Surgery Pietro Valdoni, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'DE Felice', 'Affiliation': 'Department of Radiology, Radiotherapy, Oncology and Pathology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giorgia Burrelli', 'Initials': 'GB', 'LastName': 'Scotti', 'Affiliation': 'Department of Surgery Pietro Valdoni, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Antonio V', 'Initials': 'AV', 'LastName': 'Sterpetti', 'Affiliation': 'Department of Surgery Pietro Valdoni, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mingoli', 'Affiliation': 'Department of Surgery Pietro Valdoni, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sapienza', 'Affiliation': 'Department of Surgery Pietro Valdoni, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'DE Toma', 'Affiliation': 'Department of Surgery Pietro Valdoni, Sapienza University of Rome, Rome, Italy.'}]",Anticancer research,['10.21873/anticanres.14276']
41,32366452,"A Randomized Phase II Study of Maintenance Bevacizumab, Pemetrexed or Bevacizumab Plus Pemetrexed for Advanced Non-squamous Non-small Cell Lung Cancer.","BACKGROUND/AIM
Continuation maintenance therapy is standard for advanced nonsquamous non-small cell lung cancer; however, the optimal maintenance strategy has yet to be determined.
PATIENTS AND METHODS
Patients without disease progression after four cycles of carboplatin (CBDCA)+ pemetrexed (PEM)+ bevacizumab (BEV) were randomized to maintenance therapy with BEV, PEM, or BEV+PEM. The primary endpoint was 1-year progression-free survival (PFS) rate.
RESULTS
Of the 90 patients enrolled, 64 were randomly assigned to maintenance therapy. The 1-year PFS rate was 9.1% in the BEV arm, 19.1% in the PEM arm, and 19.1% in the BEV+PEM arm. The median PFS and overall survival (OS) were 4.0 and 43.1 months in the BEV arm, 4.5 and 32.0 months in the PEM arm, and 6.4 and 41.8 months in the BEV+PEM arm.
CONCLUSION
The median PFS was numerically better in the BEV+PEM arm, but the median OS was not significantly different among the three arms.",2020,"The median PFS was numerically better in the BEV+PEM arm, but the median OS was not significantly different among the three arms.","['Advanced Non-squamous Non-small Cell Lung Cancer', '90 patients enrolled', 'Patients without disease progression after four cycles of', 'advanced nonsquamous non-small cell lung cancer']","['maintenance therapy with BEV, PEM, or BEV+PEM', 'BEV+PEM', 'Maintenance Bevacizumab, Pemetrexed or Bevacizumab Plus Pemetrexed', 'carboplatin (CBDCA)+ pemetrexed (PEM)+ bevacizumab (BEV']","['median PFS and overall survival (OS', 'median OS', '1-year PFS rate', '1-year progression-free survival (PFS) rate', 'median PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",90.0,0.100503,"The median PFS was numerically better in the BEV+PEM arm, but the median OS was not significantly different among the three arms.","[{'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Young Hak', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan ekim@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Sakamori', 'Affiliation': 'Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ozasa', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Kaneda', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Tomii', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Okada', 'Affiliation': 'Department of Respiratory Medicine, Saiseikai Suita Hospital, Suita, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Hirabayashi', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toyohiro', 'Initials': 'T', 'LastName': 'Hirai', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Anticancer research,['10.21873/anticanres.14278']
42,32363613,A randomized trial of Lactobacillus rhamnosus IDCC 3201 tyndallizate (RHT3201) for treating atopic dermatitis.,"BACKGROUND
Probiotic therapies, mainly live bacteria, have been proven to be effective in treating atopic dermatitis (AD) with some controversies. Killed probiotics or postbiotics would have immunomodulatory effect in allergic diseases including AD. This study was performed to evaluate the therapeutic effect and safety of tyndallized Lactobacillus rhamnosus (IDCC 3201, isolated from the feces of a Korean breastfed infant, repeated heat-treated and incubated, RHT3201) in children with AD.
METHODS
In a randomized, double-blind, placebo-controlled study, RHT3201 at a dose of 1.0 × 10 10 CPU/d or placebo was given in children (aged 1-12 years) with moderate AD for 12 weeks. SCORing of AD (SCORAD) scores, allergic inflammatory markers, and safety parameters were evaluated.
RESULTS
For evaluating the therapeutic effects of RHT3201, 33 subjects in each group were analyzed. The change of SCORAD total score at 12 weeks (primary outcome) from baseline was significantly greater in the RHT3201 group (-13.89 ± 10.05) compared to the control group (-8.37 ± 9.95). Levels of eosinophil cationic protein (ECP) and interleukin (IL)-31 showed tendency to decrease in the RHT3201 group and significant decreases in subgroup analysis in AD for ≥50 months. For safety analysis, a total of 100 subjects (50 in the treated group and 50 in the control group) were evaluated, and there were no significant differences in safety parameters between two groups.
CONCLUSION
In children with moderate AD, oral administration of RHT3201 showed the therapeutic effect on AD, the effects in part correlated with decrement of ECP and IL-31, and the effect was more remarkable in subgroup analysis.",2020,"Levels of eosinophil cationic protein (ECP) and interleukin (IL)-31 showed tendency to decrease in RHT3201 group, and significant decreases in subgroup analysis in AD for ≥ 50 months.","['treating atopic dermatitis', 'children with AD', '33 subjects in each group were analyzed', 'children (aged 1 to 12 years) with moderate AD for 12 weeks']","['tyndallized Lactobacillus rhamnosus (IDCC', 'Lactobacillus rhamnosus IDCC 3201 tyndallizate (RHT3201', 'placebo']","['safety parameters', 'SCOring of AD (SCORAD) scores, allergic inflammatory markers, and safety parameters', 'ECP and IL-31', 'change of SCORAD total score', 'Levels of eosinophil cationic protein (ECP) and interleukin (IL)-31']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0950373', 'cui_str': 'Eosinophilic cationic protein'}, {'cui': 'C1571097', 'cui_str': 'IL31 protein, human'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",100.0,0.233498,"Levels of eosinophil cationic protein (ECP) and interleukin (IL)-31 showed tendency to decrease in RHT3201 group, and significant decreases in subgroup analysis in AD for ≥ 50 months.","[{'ForeName': 'Kyunguk', 'Initials': 'K', 'LastName': 'Jeong', 'Affiliation': 'Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Mincheol', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'ILDONG Pharmaceutical Co., Ltd., Seoul, Korea.'}, {'ForeName': 'Se Ah', 'Initials': 'SA', 'LastName': 'Jeon', 'Affiliation': 'Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Young-Hoo', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'ILDONG Pharmaceutical Co., Ltd., Seoul, Korea.'}, {'ForeName': 'Sooyoung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13269']
43,32360399,Effect of different exercise training intensities on musculoskeletal and neuropathic pain in inactive individuals with type 2 diabetes - Preliminary randomised controlled trial.,"AIMS
People with type 2 diabetes (T2D) have a greater prevalence of musculoskeletal and neuropathic pain. This exploratory analysis investigated whether exercise of different intensities leads to changes in self-reported musculoskeletal pain or symptoms of diabetic neuropathy in inactive individuals with type 2 diabetes.
METHODS
Thirty-two inactive adults with T2D (59% male, mean age 58.7 ± 9.1yrs, median HbA 1c 7.8%) were randomised to usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT). At baseline and 8-weeks, musculoskeletal and neuropathic pain were evaluated using a modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively. Quantitative sensory testing was used to determine thermal, mechanical and vibration detection thresholds, as well as pain pressure thresholds. Adverse events were recorded throughout the intervention.
RESULTS
Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [-10.6 to -0.2], p = 0.04) and non-significantly greater for C-MICT (MD -5.9 [-12.4 to 0.7], p = 0.08). Changes in neuropathy symptoms were not different between C-HIIT and CON (MD 1.0 [-0.9 to 2.8], p = 0.31), or C-MICT and CON (MD 0.2 [-3.1 to 3.6], p = 0.89). No differences in sensory function were observed between groups. Similar rates of adverse events were seen in both exercise interventions (19 C-HIIT; 17 C-MICT), all but one of which were mild.
CONCLUSIONS
Preliminary data suggests 8-weeks of high-intensity combined aerobic and resistance exercise may be safely prescribed for inactive individuals with T2D and may reduce musculoskeletal pain but not neuropathic symptoms.
TRIAL REGISTRATION
ACTRN12615000475549.",2020,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","['inactive individuals with type 2 diabetes', 'Thirty-two inactive adults with T2D (59% male, mean age 58.7±9.1yrs, median HbA 1c 7.8', 'People with type 2 diabetes (T2D', 'Inactive Individuals with Type 2 Diabetes']","['usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT', 'CON', 'Different Exercise Training Intensities']","['modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively', 'sensory function', 'Adverse events', 'Musculoskeletal and Neuropathic Pain', 'musculoskeletal pain intensity', 'neuropathy symptoms', 'adverse events', 'pain pressure thresholds', 'musculoskeletal and neuropathic pain', 'musculoskeletal pain']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",32.0,0.143575,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Cox', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trishan', 'Initials': 'T', 'LastName': 'Gajanand', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Nicola W', 'Initials': 'NW', 'LastName': 'Burton', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Brooke K', 'Initials': 'BK', 'LastName': 'Coombes', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Nathan, Queensland, Australia. Electronic address: b.coombes@griffith.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108168']
44,32360596,What factors modify the effect of monthly bolus dose vitamin D supplementation on 25-hydroxyvitamin D concentrations?,"The increasing use of vitamin D supplements has stimulated interest in identifying factors that may modify the effect of supplementation on circulating 25-hydroxyvitamin D (25(OH)D) concentrations. Such information is of potential interest to researchers, clinicians and patients when deciding on bolus dose of vitamin D supplementation. We carried out a large randomized controlled trial of 5110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity, to whom we gave a standard dose of vitamin D 3 supplements (200,000 IU initially, then 100,000 IU monthly) which was taken with high adherence. All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study. Serum 25(OH)D was measured by LC/MSMS. Mixed model analyses were carried out on all 854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3 (Cal.D.Forte tablets), asthma/COPD and the study treatment (vitamin D or placebo). The adjusted mean difference in 25(OH)D in the follow-up points between vitamin D supplementation and placebo groups was inversely related (all p for interaction <0.05) to baseline 25(OH)D, BMI, and hours of sun exposure, and higher in females, elders, and those with high frequency of alcohol, medical prescription of vitamin D, and asthma/COPD. The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33). In summary, these data show that vitamin D status, BMI, sun exposure hours, sex and asthma/COPD modify the 25(OH)D response to vitamin D supplementation. By contrast, ethnicity, tobacco smoking, and vigorous activity do not.",2020,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","['5,110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity', 'All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study', '854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3 (Cal']","['vitamin D supplements', 'vitamin D 3 supplements', 'vitamin D or placebo', 'vitamin D supplementation', 'placebo']","['vigorous activity', 'circulating 25-hydroxyvitamin D (25(OH)D) concentrations', 'baseline 25(OH)D, BMI, and hours of sun exposure', 'Serum 25(OH)D', '25-hydroxyvitamin D concentrations', 'vitamin D status, BMI, sun exposure hours, sex and asthma/COPD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0240790', 'cui_str': 'Polynesians'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",5110.0,0.281124,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","[{'ForeName': 'Zhenqiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Beros', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlene M M', 'Initials': 'CMM', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of Public Health & General Practice, The University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health, University of Cambridge, Cambridge, England, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105687']
45,32360666,Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India.,"OBJECTIVES
Evaluate and compare contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA) in married lactating women (20-35 years) using the progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD) during the first postpartum year.
STUDY DESIGN
We conducted a one-year multicenter, non-randomized, non-inferiority, open-label, comparative trial at 20 centers in India and compared efficacy, safety, continuation and LA plus feeding patterns and growth/well-being of participants' infants. Women used four 3-month PVRs consecutively (lost PVRs were not replaced) and were to breastfeed at least four times/day. We used Pearl Index (PI) and Kaplan Meier (K-M) rates to analyze pregnancy and K-M for continuation.
RESULTS
We enrolled 789 women (459 PVR, 330 IUD). Neither PI nor K-M one-year pregnancy rates differed significantly between groups (PI: PVR-0.62; IUD-0.35); (K-M: PVR-0.7; IUD-0.4, p = 0.58). Continuation rates at 12 months were 78.5% (IUD) vs. 56.9% (PVR) (p < 0.001). Ring expulsions and menorrhagia were the most common discontinuation among PVR/IUD users respectively. The median duration of LA among PVR vs. IUD users was 405 vs. 120 days (p < 0.001). Both groups reported similar adverse events (PVR: 24.2%; IUD: 23.0%); there were no serious adverse events among PVR users. Infants from both groups fed 12-7 times/day and grew at expected rates.
CONCLUSIONS
Efficacy and safety outcomes were comparable among women in both groups. Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users. Infant breastfeeding and growth patterns/well-being were favorable in both groups.
IMPLICATIONS
PVR, a user-controlled device, offers an additional contraceptive choice for lactating women for one-year postpartum use and can help to address the unmet need for contraception among postpartum women while encouraging breastfeeding to enhance infant growth and well-being.",2020,"Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users.","['lactating women', 'lactating mothers', '789 women (459 PVR, 330 IUD', 'married lactating women (20-35 years) using the', ""participants' infants""]","['progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD', 'Progesterone vaginal ring']","['PI nor K-M one-year pregnancy rates', 'median duration of LA', 'Continuation rates', 'Pearl Index (PI) and Kaplan Meier (K-M) rates', 'Efficacy and safety outcomes', 'adverse events', 'contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0473315', 'cui_str': 'Lactational amenorrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",789.0,0.262346,"Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users.","[{'ForeName': 'Malabika', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Indian Council of Medical Research, Ansari Nagar, New Delhi, India. Electronic address: malaroy69@gmail.com.'}, {'ForeName': 'Avishek', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': 'Population Council, Zone 5A, India Habitat Centre, New Delhi, India.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Merkatz', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Plagianos', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Mohcine', 'Initials': 'M', 'LastName': 'Alami', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Gaur', 'Affiliation': 'Indian Council of Medical Research, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Kumudha', 'Initials': 'K', 'LastName': 'Aruldas', 'Affiliation': 'Population Council, Zone 5A, India Habitat Centre, New Delhi, India.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Sussman', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Variano', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Government Medical College, SMGS Hospital, Jammu, India; Postgraduate Institute of Medical Education and Research Chandigarh, India; Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India; All India Institute of Medical Sciences, New Delhi, India; K.G. Medical University, Lucknow, India; Motilal Nehru Medical College and Hospital, Prayagraj, India; GSVM Medical College and Hospital, Kanpur, India; SMS Medical College and Zanana Hospital, Jaipur, India; Institute of Obstetrics and Gynecology, Madras Medical College, Chennai, India; Government Medical College and SAT Hospital, Thiruvananthapuram, India; Jawaharlal Nehru Medical College and Hospital, Belagavi, India; Patna Medical College and Hospital, Patna, India; R.G. Kar Medical College and Hospital, Kolkata, India; Medical College and Eden Hospital, Kolkata, India; SCB Medical College and Hospital, Cuttack, India; Seth GS Medical College and KEM Hospital, Mumbai, India; KEM Hospital, Pune, India; Grant Medical College and Sir JJ Group of Hospitals, Mumbai, India; Goa Medical College and Hospital, Goa, India; Indian Council of Medical Research - National Institute for Research in Reproductive Health, Mumbai, India.'}]",Contraception,['10.1016/j.contraception.2020.04.016']
46,32370818,"Effect of antidepressants for cessation therapy in betel-quid use disorder: a randomised, double-blind, placebo-controlled trial.","AIMS
More than one-half of betel-quid (BQ) chewers have betel-quid use disorder (BUD). However, no medication has been approved. We performed a randomised clinical trial to test the efficacy of taking escitalopram and moclobemide antidepressants on betel-quid chewing cessation (BQ-CC) treatment.
METHODS
We enrolled 111 eligible male BUD patients. They were double-blinded, placebo-controlled and randomised into three treatment groups: escitalopram 10 mg/tab daily, moclobemide 150 mg/tab daily and placebo. Patients were followed-up every 2 weeks and the length of the trial was 8 weeks. The primary outcome was BQ-CC, defined as BUD patients who continuously stopped BQ use for ⩾6 weeks. The secondary outcomes were the frequency and amount of BQ intake, and two psychological rating scales. Several clinical adverse effects were measured during the 8-week treatment.
RESULTS
Intention-to-treat analysis shows that after 8 weeks, two (5.4%), 13 (34.2%) and 12 (33.3%) of BUD patients continuously quit BQ chewing for ⩾6 weeks among placebo, escitalopram, moclobemide groups, respectively. The adjusted proportion ratio of BQ-CC was 6.3 (95% CI 1.5-26.1) and 6.8 (95% CI 1.6-28.0) for BUD patients who used escitalopram and moclobemide, respectively, as compared with those who used placebo. BUD patients with escitalopram and moclobemide treatments both exhibited a significantly lower frequency and amount of BQ intake at the 8th week than those with placebo.
CONCLUSIONS
Prescribing a fixed dose of moclobemide and escitalopram to BUD patients over 8 weeks demonstrated treatment benefits to BQ-CC. Given a relatively small sample, this study provides preliminary evidence and requires replication in larger trials.",2020,"The adjusted proportion ratio of BQ-CC was 6.3 (95% CI 1.5-26.1) and 6.8 (95% CI 1.6-28.0) for BUD patients who used escitalopram and moclobemide, respectively, as compared with those who used placebo.","['BUD patients with escitalopram and', 'betel-quid use disorder', '111 eligible male BUD patients']","['placebo', 'moclobemide', 'escitalopram and moclobemide antidepressants', 'antidepressants', 'escitalopram 10 mg/tab daily, moclobemide 150 mg/tab daily and placebo']","['frequency and amount of BQ intake, and two psychological rating scales', 'frequency and amount of BQ intake', 'BQ-CC', 'adjusted proportion ratio of BQ-CC']","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0066673', 'cui_str': 'Moclobemide'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1168577', 'cui_str': 'Escitalopram 10 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1128430', 'cui_str': 'Moclobemide 150 MG'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",111.0,0.638953,"The adjusted proportion ratio of BQ-CC was 6.3 (95% CI 1.5-26.1) and 6.8 (95% CI 1.6-28.0) for BUD patients who used escitalopram and moclobemide, respectively, as compared with those who used placebo.","[{'ForeName': 'Chung-Chieh', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health and Research Center for Environment Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Albert Min-Shan', 'Initials': 'AM', 'LastName': 'Ko', 'Affiliation': 'Key Laboratory of Vertebrate Evolution and Human Origins of Chinese Academy of Sciences, Institute of Vertebrate Paleontology and Paleoanthropology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hsien-Yuan', 'Initials': 'HY', 'LastName': 'Lane', 'Affiliation': 'Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chi-Pin', 'Initials': 'CP', 'LastName': 'Lee', 'Affiliation': 'Environment-Omics-Disease Research Center, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Ying-Chin', 'Initials': 'YC', 'LastName': 'Ko', 'Affiliation': 'Environment-Omics-Disease Research Center, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000384']
47,32371539,Concurrent definitive immunoradiotherapy for patients with Stage III-IV Head and Neck Cancer and Cisplatin contraindication.,"PURPOSE
Although cisplatin plus radiotherapy is a standard treatment of locally advanced head and neck squamous cell carcinoma (LA-HNSCC), cisplatin contraindication is common. Radiation elicits and promotes tumor-directed immune-stimulation, which may potentiate anti-PD-1 therapy. We provide the first efficacy report of combined pembrolizumab and definitive radiotherapy in LA-HNSCC.
EXPERIMENTAL DESIGN
This single-arm, multi-institution, phase II study (NCT02609503) enrolled 29 cisplatin ineligible patients. Patients received radiotherapy concurrently with 3 cycles of pembrolizumab 200mg q3 weeks followed by 3 adjuvant cycles. The primary endpoint was a PFS of >16 months. Correlative studies included peripheral blood flow cytometry and Luminex cytokine profiling.
RESULTS
Reasons for cisplatin ineligibility included otopathy (69.0%), nephropathy (20.7%), and neuropathy (6.9%). With median follow-up of 21 months, estimated twenty-four month PFS and OS rates were 71% (95% CI 49-84) and 75% (51-88). The primary PFS endpoint has exceeded the hypothesis and its median has not been reached. Toxicities were typical of radiotherapy; however high rates of grade 3/4 lymphopenia (58.6%) were observed. Flow cytometry revealed a relative decline in CD4 T cells and B cells, but not CD8 T cells. Upon treatment, frequencies of transitional B cells and tissue-like memory B cells increased while resting memory B cells decreased. Patients with progression had greater percentages of baseline naïve B cells and fewer marginal zone B cells.
CONCLUSIONS
Pembrolizumab and radiotherapy is efficacious in LA-HNSCC and should be evaluated in a randomized trial. The observed changes in B-cell markers deserve further study both as potential biomarkers and as therapeutic targets.",2020,"Flow cytometry revealed a relative decline in CD4 T cells and B cells, but not CD8 T cells.","['patients with Stage III-IV Head and Neck Cancer and Cisplatin contraindication', '29 cisplatin ineligible patients', 'locally advanced head and neck squamous cell carcinoma (LA-HNSCC']","['radiotherapy', 'cisplatin plus radiotherapy', 'Concurrent definitive immunoradiotherapy', 'Pembrolizumab and radiotherapy', 'combined pembrolizumab and definitive radiotherapy', 'pembrolizumab']","['rates of grade 3/4 lymphopenia', 'nephropathy', 'OS rates', 'frequencies of transitional B cells and tissue-like memory B cells', 'peripheral blood flow cytometry and Luminex cytokine profiling', 'PFS of >16 months', 'baseline naïve B cells and fewer marginal zone B cells', 'CD4 T cells and B cells, but not CD8 T cells', 'Toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0085101', 'cui_str': 'Radioimmunotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1512631', 'cui_str': 'Immature B-Lymphocytes'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",29.0,0.0669333,"Flow cytometry revealed a relative decline in CD4 T cells and B cells, but not CD8 T cells.","[{'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Division of Hematology and Oncology, UNC Lineberger Comprehensive Cancer Center jared_weiss@med.unc.edu.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Sheth', 'Affiliation': 'Division of Hematology & Oncology, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'The Lineberger Comprehensive Cancer Center and Department of Medicine, University of North Carolina School of Medicine.'}, {'ForeName': 'Juneko E', 'Initials': 'JE', 'LastName': 'Grilley Olson', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Samip', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Hackman', 'Affiliation': 'Otolaryngology, School of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Blumberg', 'Affiliation': 'Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Galloway', 'Affiliation': 'Radiation Oncology, Fox Chase Cancer Center.'}, {'ForeName': 'Shetal', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Division of Hematology and Oncology, UNC Lineberger Comprehensive Cancer Center.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Zanation', 'Affiliation': 'Otolaryngology, School of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Colette J', 'Initials': 'CJ', 'LastName': 'Shen', 'Affiliation': 'Department of Radiation Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}, {'ForeName': 'D Neil', 'Initials': 'DN', 'LastName': 'Hayes', 'Affiliation': 'Center for Cancer Research, Univeristy of Tennessee Health Science Center.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hilliard', 'Affiliation': 'Division of Hematology and Oncology, UNC Lineberger Comprehensive Cancer Center.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Hematology and Oncology, University of Maryland, College Park.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'McKinnon', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Hsing-Hui', 'Initials': 'HH', 'LastName': 'Wang', 'Affiliation': 'Division of Hematology and Oncology, UNC Lineberger Comprehensive Cancer Center.'}, {'ForeName': 'Mark Christian', 'Initials': 'MC', 'LastName': 'Weissler', 'Affiliation': 'Otolaryngology, School of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Bauman', 'Affiliation': 'Hematology and Oncology, Fox Chase Cancer Center.'}, {'ForeName': 'Bhishamjit S', 'Initials': 'BS', 'LastName': 'Chera', 'Affiliation': 'Department of Radiation Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Vincent', 'Affiliation': 'Hematology/Oncology, UNC Lineberger Comprehensive Cancer Centre.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0230']
48,32379048,Web-Based Intervention Effects on Mild Cognitive Impairment Based on Apolipoprotein E Genotype: Quasi-Experimental Study.,"BACKGROUND
Apolipoprotein E (APOE) ε4 allele is a major genetic risk factor for Alzheimer disease and mild cognitive impairment (MCI). Computer-based training programs can improve cognitive performance in elderly populations. However, the effects of computer-based interventions on MCI APOE ε4 carriers have never been studied before.
OBJECTIVE
The effects of different web-based interventions and the APOE isoform-specific differences in training outcomes are investigated.
METHODS
Using a quasi-experimental study design, 202 participants with MCI aged 60 years and older took part in three different intervention programs (physical and cognitive [Long-Lasting Memories, or LLM], cognitive [Active Control, or AC], or physical intervention [Physical Training Control, or PTC]) via an innovative information and communication technologies exergaming platform. Participants in each interventional group were subdivided into APOE ε4 carriers and non-APOE ε4 carriers. All participants underwent an extensive neuropsychological evaluation before and after the training, blood tests, and brain imaging.
RESULTS
All interventions resulted in multiple statistically significant cognitive benefits after the intervention. Verbal learning (California Verbal Learning Test: immediate recall test score-LLM: P=.04; AC: P<.001), working memory (digit span forward and backward test scores-AC: P=.03; PTC: P=.02 and P=.006, respectively), and long-term memory (California Verbal Learning Test: delayed recall test score-LLM: P=.02; AC: P=.002; and PTC: P=.02) were improved. There was no statistically significant difference among the intervention effects. APOE ε4 presence moderates intervention effects as the LLM intervention improved only their task-switching processing speed (Trail Making Test, Part B: P=.03) and the PTC intervention improved only the working memory (digit span backward: P=.03). No significant performance alteration was noted for the APOE ε4+ cognitive AC training group.
CONCLUSIONS
None of the applied interventions could be identified as the optimal one; it is suggested, however, that combined cognitive and physical training and physical training via exergaming may be more effective for the high-risk MCI ΑPOE ε4+ subgroup.",2020,"immediate recall test score-LLM: P=.04; AC: P<.001), working memory (digit span forward and backward test scores-AC:","['elderly populations', '202 participants with MCI aged 60 years and older took part in three different']","['intervention programs (physical and cognitive [Long-Lasting Memories, or LLM], cognitive [Active Control, or AC], or physical intervention [Physical Training Control, or PTC]) via an innovative information and communication technologies exergaming platform', 'Verbal learning (California Verbal Learning Test', 'APOE', 'Computer-based training programs', 'LLM intervention', 'Apolipoprotein E (APOE']","['cognitive performance', 'working memory (digit span forward and backward test scores-AC', 'task-switching processing speed (Trail Making Test, Part B: P=.03) and the PTC intervention improved only the working memory', 'Mild Cognitive Impairment', 'performance alteration']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0589055', 'cui_str': 'California verbal learning test'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]",202.0,0.0232114,"immediate recall test score-LLM: P=.04; AC: P<.001), working memory (digit span forward and backward test scores-AC:","[{'ForeName': 'Anthoula C', 'Initials': 'AC', 'LastName': 'Tsolaki', 'Affiliation': 'Medical Physics Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Tsolaki', 'Affiliation': '1st Department of Neurology, American Hellenic Educational Progressive Association Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Pandria', 'Affiliation': 'Medical Physics Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Eftychia', 'Initials': 'E', 'LastName': 'Lazarou', 'Affiliation': '1st Department of Neurology, American Hellenic Educational Progressive Association Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Olymbia', 'Initials': 'O', 'LastName': 'Gkatzima', 'Affiliation': 'Panhellenic Institute of Neurodegenerative Diseases, Thessaloniki, Greece.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Zilidou', 'Affiliation': 'Medical Physics Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karagianni', 'Affiliation': 'Medical Physics Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Zafiroula', 'Initials': 'Z', 'LastName': 'Iakovidou-Kritsi', 'Affiliation': 'Laboratory of Medical Biology-Genetics Department, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vasilios K', 'Initials': 'VK', 'LastName': 'Kimiskidis', 'Affiliation': 'Laboratory of Clinical Neurophysiology, American Hellenic Educational Progressive Association Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Panagiotis D', 'Initials': 'PD', 'LastName': 'Bamidis', 'Affiliation': 'Medical Physics Laboratory, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Journal of medical Internet research,['10.2196/14617']
49,32348267,Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial.,"BACKGROUND
Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs). Less than 1.0% (1/100) of these patients have a neck bone fracture. Even less (1/200, 0.5%) have a spinal cord injury or nerve damage. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, cervical collar, and head immobilizers. Importantly, prolonged immobilization is often unnecessary; it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly. We therefore developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury. We successfully taught Ottawa paramedics to use the CCR in the field in a single-center study.
OBJECTIVE
This study aimed to improve patient care and health system efficiency and outcomes by allowing paramedics to assess eligible low-risk trauma patients with the CCR and selectively transport them without immobilization to the ED.
METHODS
We propose a pragmatic stepped-wedge cluster randomized design with health economic evaluation, designed collaboratively with knowledge users. Our 36-month study will consist of a 12-month setup and training period (year 1), followed by the stepped-wedge trial (year 2) and a 12-month period for study completion, analyses, and knowledge translation. A total of 12 Ontario paramedic services of various sizes distributed across the province will be randomly allocated to one of three sequences. Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention. Data will be collected on all eligible patients in each paramedic service for a total duration of 12 months. A major strength of our design is that each community will have implemented the CCR by the end of the study.
RESULTS
Interim results are expected in December 2019 and final results in 2020. If this multicenter trial is successful, we expect the Ontario Ministry of Health will recommend that paramedics evaluate all eligible patients with the CCR in the Province of Ontario.
CONCLUSIONS
We conservatively estimate that in Ontario, more than 60% of all eligible trauma patients (300,000 annually) could be transported safely and comfortably, without c-spine immobilization devices. This will significantly reduce patient pain and discomfort, paramedic intervention times, and ED length of stay, thereby improving access to paramedics and ED care. This could be achieved rapidly and with lower health care costs compared with current practices (possible cost saving of Can $36 [US $25] per immobilization or Can $10,656,000 [US $7,335,231] per year).
TRIAL REGISTRATION
ClinicalTrials.gov NCT02786966; https://clinicaltrials.gov/ct2/show/NCT02786966.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/16966.",2020,Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention.,"['eligible patients in each paramedic service for a total duration of 12 months', 'eligible low-risk trauma patients with the CCR and selectively transport them without immobilization to the ED', 'million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs', 'Low-Risk Trauma Patients', 'eligible patients with the CCR in the Province of Ontario', '12 Ontario paramedic services of various sizes distributed across the province']","['Canadian C-Spine Rule and Selectively Transport', 'Canadian C-Spine Rule (CCR']","['spinal cord injury or nerve damage', 'patient pain and discomfort, paramedic intervention times, and ED length of stay, thereby improving access to paramedics and ED care', 'neck bone fracture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}]","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",,0.116697,Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vaillancourt', 'Affiliation': 'Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Manya', 'Initials': 'M', 'LastName': 'Charette', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Patient Representative, Owner-Hall Consulting, Director-Helping Hands for India, Kanata, ON, Canada.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'McLeod', 'Affiliation': 'Paramedic Representative, Hamilton Paramedic Service, Hamilton, ON, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brehaut', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Graham', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Calder', 'Affiliation': 'Medical Care Analytics, Canadian Medical Protective Association, Ottawa, ON, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tugwell', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Ottawa Paramedic Service, Ottawa, ON, Canada.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Cheskes', 'Affiliation': 'Department of Family and Community Medicine, Division of Emergency Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Refik', 'Initials': 'R', 'LastName': 'Saskin', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Plint', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Osmond', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Macarthur', 'Affiliation': 'Clinical Research Services, SickKids, Toronto, ON, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Straus', 'Affiliation': ""Knowledge Translation Program, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rochon', 'Affiliation': ""Women's College Research Institute, Toronto, ON, Canada.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""Prud'homme"", 'Affiliation': ""Institut de recherche de l'Hôpital Montfort, Ottawa, ON, Canada.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Dahrouge', 'Affiliation': 'Élisabeth Bruyère Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Marlin', 'Affiliation': 'Clinical Trials Ontario, Toronto, ON, Canada.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Stiell', 'Affiliation': 'Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}]",JMIR research protocols,['10.2196/16966']
50,32348270,A Mobile Health Intervention System for Women With Coronary Heart Disease: Usability Study.,"BACKGROUND
Coronary heart disease (CHD) is the leading cause of death and disability among American women. The prevalence of CHD is expected to increase by more than 40% by 2035. In 2015, the estimated cost of caring for patients with CHD was US $182 billion in the United States; hospitalizations accounted for more than half of the costs. Compared with men, women with CHD or those who have undergone coronary revascularization have up to 30% more rehospitalizations within 30 days and up to 1 year. Center-based cardiac rehabilitation is the gold standard of care after an acute coronary event, but few women attend these valuable programs. Effective home-based interventions for improving cardiovascular health among women with CHD are vital for addressing this gap in care.
OBJECTIVE
The ubiquity of mobile phones has made mobile health (mHealth) behavioral interventions a viable option to improve healthy behaviors of both women and men with CHD. First, this study aimed to examine the usability of a prototypic mHealth intervention designed specifically for women with CHD (herein referred to as HerBeat). Second, we examined the influence of HerBeat on selected health behaviors (self-efficacy for diet, exercise, and managing chronic illness) and psychological (perceived stress and depressive symptoms) characteristics of the participants.
METHODS
Using a single-group, pretest, posttest design, 10 women participated in the 12-week usability study. Participants were provided a smartphone and a smartwatch on which the HerBeat app was installed. Using a web portal dashboard, a health coach monitored participants' ecological momentary assessment data, their behavioral data, and their heart rate and step count. Participants then completed a 12-week follow-up assessment.
RESULTS
All 10 women (age: mean 64.4 years, SD 6.3 years) completed the study. The usability and acceptability of HerBeat were good, with a mean system usability score of 83.60 (SD 16.3). The participants demonstrated statistically significant improvements in waist circumference (P=.048), weight (P=.02), and BMI (P=.01). Furthermore, depressive symptoms, measured with the Patient Health Questionnaire-9, significantly improved from baseline (P=.04).
CONCLUSIONS
The mHealth prototype was feasible and usable for women with CHD. Participants provided data that were useful for further development of HerBeat. The mHealth intervention is expected to help women with CHD self-manage their health behaviors. A randomized controlled trial is needed to further verify the findings.",2020,"The participants demonstrated statistically significant improvements in waist circumference (P=.048), weight (P=.02), and BMI (P=.01).","['Women With Coronary Heart Disease', 'American women', 'women with CHD', '10 women participated in the 12-week usability study', 'All 10 women (age: mean 64.4 years, SD 6.3 years) completed the study', 'women with CHD (herein referred to as HerBeat', 'women and men with CHD']","['Mobile Health Intervention System', 'Center-based cardiac rehabilitation']","['Patient Health Questionnaire-9', 'waist circumference', 'weight (P=.02), and BMI', 'cardiovascular health', 'mean system usability score', 'estimated cost of caring', 'prevalence of CHD', 'selected health behaviors (self-efficacy for diet, exercise, and managing chronic illness) and psychological (perceived stress and depressive symptoms', 'Furthermore, depressive symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",10.0,0.10749,"The participants demonstrated statistically significant improvements in waist circumference (P=.048), weight (P=.02), and BMI (P=.01).","[{'ForeName': 'Avijit', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Information Systems and Decision Sciences, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Beckie', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Dutta', 'Affiliation': 'Information Systems and Decision Sciences, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Dey', 'Affiliation': 'College of Engineering, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Chellappan', 'Affiliation': 'College of Engineering, University of South Florida, Tampa, FL, United States.'}]",JMIR formative research,['10.2196/16420']
51,32356211,Antibacterial activity of fluoride varnishes containing different agents in children with severe early childhood caries: a randomised controlled trial.,"OBJECTIVES
The aim of this study was to compare the antibacterial activity of fluoride varnishes containing different agents in children with severe early childhood caries (S-ECC).
MATERIALS AND METHODS
The study was conducted in 92 children with S-ECC. Patients who completed dental treatment under general anaesthesia were included in the study. Patients were divided randomly into four groups: 5% sodium fluoride (SF) control group (n = 23), 5% SF with tricalcium phosphate (TCP) (n = 23), 5% SF with xylitol-coated calcium and phosphate (CXP) (n = 23) and 5% SF with casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (n = 23). Saliva mutans streptococci (MS) and lactobacilli (LB) levels were evaluated by taking saliva samples at baseline (T 0 ), 1 month (T 1 ) and 3 months (T 2 ) after treatment.
RESULTS
All groups showed a significant decrease in MS and LB levels at T 1 (P < 0.05) except the CXP group. Only the TCP group exhibited significantly decrease MS and LB levels indicating less than 10 5 CFU at both T 1 and T 2 compared with the other groups (P < 0.05).
CONCLUSION
Fluoride varnish with TCP provided significantly more reduction in MS and LB levels than other fluoride varnishes.
CLINICAL RELEVANCE
Fluoride varnish with TCP had a significant antibacterial effect against cariogenic bacteria until the end of the third month. Long lasting antibacterial effect provides additional advantage for reducing bacteria levels in children.
CLINICAL TRIALS REGISTRATION NUMBER
NCT03625310.",2020,All groups showed a significant decrease in MS and LB levels at T 1 (P < 0.05) except the CXP group.,"['children with severe early childhood caries', 'children', 'children with severe early childhood caries (S-ECC', 'Patients who completed dental treatment under general anaesthesia were included in the study', '92 children with S-ECC']","['fluoride varnishes', 'sodium fluoride (SF) control group (n\xa0=\u200923), 5% SF with tricalcium phosphate (TCP) (n\xa0=\u200923), 5% SF with xylitol-coated calcium and phosphate (CXP) (n\xa0=\u200923) and 5% SF with casein phosphopeptide-amorphous calcium phosphate (CPP-ACP', 'TCP', 'Fluoride varnish with TCP']","['MS and LB levels', 'antibacterial activity', 'Antibacterial activity', 'bacteria levels', 'Saliva mutans streptococci (MS) and lactobacilli (LB) levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]",92.0,0.0392861,All groups showed a significant decrease in MS and LB levels at T 1 (P < 0.05) except the CXP group.,"[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Erkmen Almaz', 'Affiliation': 'Faculty of Dentistry, Department of Paediatric Dentistry, Kırıkkale University, Kırıkkale, Turkey. dt.merveerkmen@gmail.com.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Akbay Oba', 'Affiliation': 'Faculty of Dentistry, Department of Paediatric Dentistry, Kırıkkale University, Kırıkkale, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03300-w']
52,32367734,Effects of Far-Infrared Therapy on Foot Circulation Among Hemodialysis Patients With Diabetes Mellitus.,"BACKGROUND
Far-infrared radiation (FIR) therapy improves vessel dilation, circulation, vessel endothelial function, and angiogenesis and reduces atherosclerosis. However, evidence of FIR therapy's effects on foot circulation among diabetic patients undergoing hemodialysis is scarce.
AIM
To determine whether FIR therapy improves foot circulation in diabetic patients undergoing hemodialysis.
DESIGN
Quasi-experimental.
METHODS
In June to November 2017, diabetic patients undergoing hemodialysis ( N = 58) at a hemodialysis center in northern Taiwan were divided into two groups: the experimental group ( n = 31) received FIR therapy to the bilateral dorsalis pedis artery (40 min/session, 3 times/week for 6 months) and the control group ( n = 27) received conventional dialysis care. Paired t test, independent samples t test, two-proportion Z test, and repeated-measures analysis of covariance were performed to compare changes from baseline to the end of the 6-month intervention between the groups.
RESULTS
Significant positive effects of FIR therapy on temperature, pulse, and blood flow of the dorsalis pedis artery were observed. Sensitivity to pain, tactility, and pressure also improved significantly in the experimental group. The Edinburgh Claudication Questionnaire revealed that the experimental group had reductions in subjective experiences of soreness, tingling, and coldness in the feet.
CONCLUSION
The findings of significant improvements to objective and subjective measures of blood flow and neural function in the experimental group indicate that FIR therapy improves blood circulation to the feet. This therapy thus has great potential to be an effective adjuvant treatment for patients with diabetes mellitus undergoing hemodialysis.",2020,"Sensitivity to pain, tactility, and pressure also improved significantly in the experimental group.","['diabetic patients undergoing hemodialysis', 'diabetic patients undergoing hemodialysis is scarce', 'In June to November 2017, diabetic patients undergoing hemodialysis ( N = 58) at a hemodialysis center in northern Taiwan', 'patients with diabetes mellitus undergoing hemodialysis', 'Hemodialysis Patients With Diabetes Mellitus']","['conventional dialysis care', 'FIR therapy to the bilateral dorsalis pedis artery', 'Far-Infrared Therapy', 'FIR therapy', 'Far-infrared radiation (FIR) therapy']","['Sensitivity to pain, tactility, and pressure', 'subjective experiences of soreness, tingling, and coldness in the feet', 'blood flow and neural function', 'vessel dilation, circulation, vessel endothelial function, and angiogenesis and reduces atherosclerosis', 'Edinburgh Claudication Questionnaire', 'temperature, pulse, and blood flow of the dorsalis pedis artery', 'Foot Circulation', 'foot circulation', 'blood circulation']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1161201', 'cui_str': 'Dialysis care'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0204032', 'cui_str': 'Infrared radiation therapy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0812387', 'cui_str': 'Feels cold'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C2711423', 'cui_str': 'Edinburgh claudication questionnaire'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]",,0.0142941,"Sensitivity to pain, tactility, and pressure also improved significantly in the experimental group.","[{'ForeName': 'Yu-Hung', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'Nursing Department, Keelung Hospital Ministry of Health and Welfare, Keelung City.'}, {'ForeName': 'Fang-Yu', 'Initials': 'FY', 'LastName': 'Cheng', 'Affiliation': 'Institute of Long-Term Care, Mackay Medical College, New Taipei City.'}, {'ForeName': 'Yann-Fen C', 'Initials': 'YC', 'LastName': 'Chao', 'Affiliation': 'College of Nursing, Hungkuang University, Taichung City.'}, {'ForeName': 'Chieh-Yu', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Allied Health Education and Digital Learning, National Taipei University of Nursing and Health Sciences, Taipei City.'}, {'ForeName': 'Yuanmay', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Institute of Long-Term Care, Mackay Medical College, New Taipei City.'}]",Biological research for nursing,['10.1177/1099800420923730']
53,32359506,"Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study.","BACKGROUND
The emergence of highly active novel agents has led some to question the role of autologous haematopoietic stem-cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myeloma. We therefore compared autologous HSCT with bortezomib-melphalan-prednisone (VMP) as intensification therapy, and bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy with no consolidation.
METHODS
In this randomised, open-label, phase 3 study we recruited previously untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network. Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein >10 g/L or urine M protein >200 mg in 24 h or abnormal free light chain [FLC] ratio with involved FLC >100 mg/L, or proven plasmacytoma by biopsy), and WHO performance status grade 0-2 (grade 3 was allowed if secondary to myeloma). Patients were first randomly assigned (1:1) to receive either four 42-day cycles of bortezomib (1·3 mg/m 2 administered intravenously or subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32) combined with melphalan (9 mg/m 2 administered orally on days 1-4) and prednisone (60 mg/m 2 administered orally on days 1-4) or autologous HSCT after high-dose melphalan (200 mg/m 2 ), stratified by site and ISS disease stage. In centres with a double HSCT policy, the first randomisation (1:1:1) was to VMP or single or double HSCT. Afterwards, a second randomisation assigned patients to receive two 28-day cycles of consolidation therapy with bortezomib (1·3 mg/m 2 either intravenously or subcutaneously on days 1, 4, 8, and 11), lenalidomide (25 mg orally on days 1-21), and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12) or no consolidation; both groups received lenalidomide maintenance therapy (10 mg orally on days 1-21 of a 28-day cycle). The primary outcomes were progression-free survival from the first and second randomisations, analysed in the intention-to-treat population, which included all patients who underwent each randomisation. All patients who received at least one dose of study drugs were included in the safety analyses. This study is registered with the EU Clinical Trials Register (EudraCT 2009-017903-28) and ClinicalTrials.gov (NCT01208766), and has completed recruitment.
FINDINGS
Between Feb 25, 2011, and April 3, 2014, 1503 patients were enrolled. 1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428). The data cutoff date for the current analysis was Nov 26, 2018. At a median follow-up of 60·3 months (IQR 52·2-67·6), median progression-free survival was significantly improved with autologous HSCT compared with VMP (56·7 months [95% CI 49·3-64·5] vs 41·9 months [37·5-46·9]; hazard ratio [HR] 0·73, 0·62-0·85; p=0·0001). For the second randomisation, the number of events of progression or death at data cutoff was lower than that preplanned for the final analysis; therefore, the results from the second protocol-specified interim analysis, when 66% of events were reached, are reported (data cutoff Jan 18, 2018). At a median follow-up of 42·1 months (IQR 32·3-49·2), consolidation therapy with VRD significantly improved median progression-free survival compared with no consolidation (58·9 months [54·0-not estimable] vs 45·5 months [39·5-58·4]; HR 0·77, 0·63-0·95; p=0·014). The most common grade ≥3 adverse events in the autologous HSCT group compared to the VMP group included neutropenia (513 [79%] of 652 patients vs 137 [29%] of 472 patients), thrombocytopenia (541 [83%] vs 74 [16%]), gastrointestinal disorders (80 [12%] vs 25 [5%]), and infections (192 [30%] vs 18 [4%]). 239 (34%) of 702 patients in the autologous HSCT group and 135 (27%) of 495 in the VMP group had at least one serious adverse event. Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189). 38 (12%) of 311 deaths from first randomisation were likely to be treatment related: 26 (68%) in the autologous HSCT group and 12 (32%) in the VMP group, most frequently due to infections (eight [21%]), cardiac events (six [16%]), and second primary malignancies (20 [53%]).
INTERPRETATION
This study supports the use of autologous HSCT as intensification therapy and the use of consolidation therapy in patients with newly diagnosed multiple myeloma, even in the era of novel agents. The role of high-dose chemotherapy needs to be reassessed in future studies, in particular in patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus dexamethasone.
FUNDING
Janssen and Celgene.",2020,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"['untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network', 'Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein', 'patients with newly diagnosed multiple myeloma', '1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428', '1503 patients were enrolled', 'patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus', 'All patients who received at least one dose of study drugs were included in the safety analyses', 'Between Feb 25, 2011, and April 3, 2014', 'newly diagnosed multiple myeloma (EMN02/HO95']","['VMP or single or double HSCT', 'prednisone', 'autologous HSCT after high-dose melphalan', 'lenalidomide', 'dexamethasone', 'bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy', 'melphalan', 'consolidation therapy with bortezomib', 'lenalidomide maintenance therapy', 'autologous HSCT', 'VMP', 'bortezomib', 'L or urine M protein', 'Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy', 'autologous haematopoietic stem-cell transplantation (HSCT', 'autologous HSCT with bortezomib-melphalan-prednisone (VMP']","['median progression-free survival', 'neutropenia', 'progression-free survival', 'number of events of progression or death at data cutoff', 'gastrointestinal disorders', 'cardiac events', 'serious adverse event', 'thrombocytopenia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",1503.0,0.203417,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy. Electronic address: michele.cavo@unibo.it.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gay', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Pantani', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Hematology, Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dozza', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'Department of Trials and Statistics-HOVON Data Centre, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Hematology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Oliva', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Vincent H J', 'Initials': 'VHJ', 'LastName': 'van der Velden', 'Affiliation': 'Department of Immunology, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zamagni', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Giuseppe A', 'Initials': 'GA', 'LastName': 'Palumbo', 'Affiliation': 'Dipartimento di Science Mediche Chirurgiche e Tecnologie Avanzate ""GF Ingrassia"", Università degli Studi di Catania, Catania, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Patriarca', 'Affiliation': 'Clinical Hematology and Bone Marrow Transplant Centre, S Maria della Misericordia University Hospital, DAME, University of Udine, Udine, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Montefusco', 'Affiliation': 'Hematology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, ASST-Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Maisnar', 'Affiliation': '4th Department of Internal Medicine-Hematology, Charles University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gamberi', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hansson', 'Affiliation': 'Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Belotti', 'Affiliation': 'SC Ematologia e Dipartimento di Oncologia Clinica, AO Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, Haga Hospital, The Hague, Netherlands.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'SC Ematologia, Azienda Ospedaliera S Croce-Carle, Cuneo, Italy.'}, {'ForeName': 'Alexsandra', 'Initials': 'A', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Stelvio', 'Initials': 'S', 'LastName': 'Ballanti', 'Affiliation': 'Reparto di Ematologia con TMO, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Offidani', 'Affiliation': 'Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy.'}, {'ForeName': 'Iolanda D', 'Initials': 'ID', 'LastName': 'Vincelli', 'Affiliation': 'Division of Haematology, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Zambello', 'Affiliation': 'Hematology, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Faculty of Medicine, Università degli Studi di Perugia, Perugia, Italy.'}, {'ForeName': 'Niels Frost', 'Initials': 'NF', 'LastName': 'Andersen', 'Affiliation': 'Department of Haematology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Troia', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pascarella', 'Affiliation': ""Hematology Unit, Ospedale dell'Angelo, Mestre, Venice, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Benevolo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Department of Haematology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Ludwig', 'Affiliation': 'Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aquino', 'Affiliation': 'Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Morelli', 'Affiliation': 'Clinical Hematology, Department of Hematology, Transfusion Medicine and Biotechnology, ""Spirito Santo"" Civic Hospital, Pescara, Italy.'}, {'ForeName': 'Ka Lung', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'Boersma', 'Affiliation': 'Department of Internal Medicine, Amphia Hospital Breda, Breda, Netherlands.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava and University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Durian', 'Affiliation': 'University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'von dem Borne', 'Affiliation': 'Department of Hematology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Caravita di Toritto', 'Affiliation': 'UOSD Ematologia ASL Roma 1, Rome, Italy.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Zander', 'Affiliation': 'Department Oncology/Hematology, Kantonsspital, Lucerne, Switzerland.'}, {'ForeName': 'Giorgina', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Hematology, University Aldo Moro, Bari, Italy.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'Department of Hematology, St Olavs Hospital and Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gimsing', 'Affiliation': 'Department of Haematology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Department of Medicine, Section of Hematology and Coagulation, South Elvsborg Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Kliniek, Zwolle, Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, UMC Utrecht, University Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mandigers', 'Affiliation': 'Department of Hematology, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cafro', 'Affiliation': 'Department of Hematology, ASST Grande Ospedale Metropolitano, Niguarda, Milan, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Palmas', 'Affiliation': 'Haematology, Ospedale San Francesco, Nuoro, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Carvalho', 'Affiliation': 'Instituto Português de Oncologia de Lisboa Francisco Gentil, IPOLFG, Lisbon, Portugal.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Department of Haematology, Alfred Hospital-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30099-5']
54,32362132,Predictors of improved balance performance in persons with Parkinson's disease following a training intervention: analysis of data from an effectiveness-implementation trial.,"OBJECTIVE
(1) To determine associated factors of improved balance performance after a 10-week HiBalance intervention period, and (2) to determine effects of the programme on modifiable factors found above, considering both groups.
DESIGN
Pre-posttest substudy founded on the outcomes evaluation of an effectiveness-implementation trial.
PARTICIPANTS
Sixty-one participants were allocated the HiBalance training, while 56 were controls.
INTERVENTION
Participants received a 10-week, two times weekly, progressive balance training, that is, HiBalance intervention, led by physical therapists. The intervention was group based and gradually incorporated dual-tasking over the training period. Participants also performed, unsupervised, a 1×/week home exercise programme.
MAIN OUTCOME
The Mini-Balance Evaluation Systems Test (Mini-BESTest) assessed balance performance, and those having improved by ⩾2 points were classified as positive responders. Balance confidence was the secondary outcome.
RESULTS
Fifty-three (87%) participants completed the intervention and 32 (60%) improved their balance scores by ⩾2 points in the intervention group, with 11 (24%) in the control group. The multivariable logistic regression analysis revealed two independently associated factors of improved balance, which included balance confidence (odds ratio (OR) = 0.95; 95% confidence interval (CI) = 0.90-0.99) and attendance of ⩾80% of training sessions (OR = 10.10; 95% CI = 1.71-59.60). The final model demonstrated good fit and acceptable discrimination (area under the curve = 0.84). Secondary analysis revealed a fair relationship (Rho = 0.30; P = 0.044) between improvements in balance confidence and balance performance in the intervention but not control group.
CONCLUSION
Two personal factors were significantly associated with a higher likelihood of improvement in clinically measured balance performance. The HiBalance intervention appears to benefit those with lower balance confidence.",2020,"participants completed the intervention and 32 (60%) improved their balance scores by ⩾2 points in the intervention group, with 11 (24%) in the control group.","[""persons with Parkinson's disease following a training intervention"", 'Fifty-three (87', 'Sixty-one participants were allocated the HiBalance training, while 56 were controls']","['progressive balance training, that is, HiBalance intervention, led by physical therapists', 'HiBalance intervention']","['balance confidence and balance performance', 'balance performance', 'balance scores', 'Mini-Balance Evaluation Systems Test (Mini-BESTest) assessed balance performance, and those having improved by\u2009⩾2 points', 'Balance confidence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by'}]",61.0,0.0677446,"participants completed the intervention and 32 (60%) improved their balance scores by ⩾2 points in the intervention group, with 11 (24%) in the control group.","[{'ForeName': 'Conran', 'Initials': 'C', 'LastName': 'Joseph', 'Affiliation': 'Division of Physiotherapy, Department of Health and Rehabilitation Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Breiffni', 'Initials': 'B', 'LastName': 'Leavy', 'Affiliation': 'Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Flemingsberg, Sweden.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Franzén', 'Affiliation': 'Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Flemingsberg, Sweden.'}]",Clinical rehabilitation,['10.1177/0269215520917199']
55,32360887,Methodology and baseline characteristics of a randomized controlled trial testing a health care professional and peer-support program for patients with chronic obstructive pulmonary disease: The BREATHE2 study.,"BACKGROUND
Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL). However, it remains unclear what SMS strategies are most effective. Using peer support to advance self-management is promising, as peer supporters possess credibility and can serve as role models.
METHODS
We conducted a single-blinded RCT comparing the effectiveness of two strategies to support patients with COPD. The strategies were 'Health Care Professional (HCP)' and 'HCP Plus Peer' support. Peer support was provided by patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter. We enrolled patients receiving treatment at inpatient and outpatient settings. Patients were encouraged to invite one family-caregiver to enroll with them. The primary outcome measure was the change in HRQOL at 6 months post enrollment. Secondary outcomes included COPD-related and all-cause hospitalizations and ED visits. Caregiver outcomes included preparedness for caregiving, caregiver stress, and coping.
RESULTS
A total of 292 patients as well as 50 family-caregivers were enrolled. The average patient age was 67.3 yrs. (SD 9.4), 61% were female and 26% were African-Americans. The majority of caregivers were females (68%) and were a spouse/partner (58%).
DISCUSSION
This study tested a dual strategy for providing support to patients with COPD that incorporates peer and health care professional support. The study had minimal exclusion criteria. If shown effective, the study offers a program of peer support that can be readily implemented in health care settings.",2020,"BACKGROUND
Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL).","['patients with chronic obstructive pulmonary disease', 'patients with COPD that incorporates peer and health care professional support', 'patients with COPD', 'enrolled patients receiving treatment at inpatient and outpatient settings', 'patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter', '292 patients and into this study as well as 50 family-caregivers were enrolled']","['Self-management support (SMS', 'health care professional and peer-support program']","['COPD-related and all-cause hospitalizations and ED visits', 'health-related quality of life (HRQOL', 'preparedness for caregiving, caregiver stress, and coping', 'change in HRQOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",292.0,0.0760412,"BACKGROUND
Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL).","[{'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Aboumatar', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA; Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21218, USA; Department of Health, Behavior, and Society, Bloomberg School of Public Health, Johns Hopkins University, 601 North Caroline Street, Suite 2080, Baltimore, MD 21205, USA; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, 2024 East Monument Street, Baltimore, MD 21287, USA. Electronic address: habouma1@jhmi.edu.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Naqibuddin', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Neiman', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA; Department of Internal Medicine, Hackensack University Medical Center, 30 Prospect Avenue, Hackensack, NJ 07601, USA.'}, {'ForeName': 'Jamia', 'Initials': 'J', 'LastName': 'Saunders', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Chaudhry', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Garcia-Morales', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA; Johns Hopkins University Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'McBurney', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Jager', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Tokunbo', 'Initials': 'T', 'LastName': 'Ajayi', 'Affiliation': 'Howard County General Hospital, 5755 Cedar Lane, Columbia, MD 21044, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bone', 'Affiliation': 'Department of Health, Behavior, and Society, Bloomberg School of Public Health, Johns Hopkins University, 601 North Caroline Street, Suite 2080, Baltimore, MD 21205, USA.'}, {'ForeName': 'Suna', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, 2024 East Monument Street, Baltimore, MD 21287, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Farrell', 'Affiliation': 'Howard County General Hospital, 5755 Cedar Lane, Columbia, MD 21044, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Joo Jin', 'Affiliation': 'Department of Psychiatry, Johns Hopkins School of Medicine, 600 North Wolfe Street, Baltimore, MD 21287, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Linnell', 'Affiliation': 'BREATHE2 Study, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Pirfo', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Rand', 'Affiliation': 'Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Riley', 'Affiliation': 'BREATHE2 Study, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Salvaterra', 'Affiliation': 'Pulmonary Disease & Critical Care Medicine, Johns Hopkins Community Physicians, 11085 Little Patuxent Parkway, Columbia, MD 21044, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Shea', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Jorawar', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Howard County General Hospital, 5755 Cedar Lane, Columbia, MD 21044, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106023']
56,32361032,Ethnicity moderates outcome in family focused treatment for pediatric obsessive compulsive disorder.,"OBJECTIVE
This study examined predictors and moderators of treatment outcome in a randomized controlled trial (RCT) comparing two active interventions for pediatric obsessive compulsive disorder that differed with respect to the focus and format of family intervention. We had a particular interest in the role of race/ethnicity in shaping outcomes given our relatively diverse sample composition and the limited prior work in this area.
METHOD
A total of 62 youths (Mean age = 12.71 years; 57 % male; 34 % non-white) were assigned to either a standard cognitive behavioral therapy (CBT) family intervention (ST) or to a tailored intervention designed for cases of OCD complicated by poor family functioning (Enhanced Family Therapy; ET). Treatment in both arms involved 12 sessions of exposure therapy; the family interventions differed. Predictor and moderator variables were chosen based on the extant literature.
RESULTS
Minority status did not predict outcome, suggesting that overall, white and non-white youth had comparable treatment response. Race/ethnicity did, however, moderate response with non-white youth faring better in the ET arm of the study. In particular, minority youth in ET had, on average, post-treatment CYBOCS scores consistent with clinical remission whereas their ST counterparts were left with symptoms considered moderately severe. There were no predictors of treatment outcome.
CONCLUSIONS
Minority status predicts poorer response to standard CBT across disorders, suggesting the need for possible treatment adaptations. The present findings highlight one avenue for matching patients to treatments that might optimize outcomes and underscore the value of family involvement in OCD treatment.",2020,"There were no predictors of treatment outcome.
","['pediatric obsessive compulsive disorder', '62 youths (Mean age\u2009=\u200912.71 years; 57 % male; 34 % non-white']",['standard cognitive behavioral therapy (CBT) family intervention (ST) or to a tailored intervention designed for cases of OCD complicated by poor family functioning (Enhanced Family Therapy; ET'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]",[],62.0,0.0176714,"There were no predictors of treatment outcome.
","[{'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States. Electronic address: tperis@mednet.ucla.edu.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, United States.'}, {'ForeName': 'Sunhye', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Pennsylvania State University, United States.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}, {'ForeName': 'Hardian', 'Initials': 'H', 'LastName': 'Thamrin', 'Affiliation': 'University of Arizona, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102229']
57,32372561,"Local Administration of Methylcobalamin for Subacute Ophthalmic Herpetic Neuralgia: A Randomized, Phase III Clinical Trial.","OBJECTIVES
The ophthalmic branch of the trigeminal nerve is one of the most frequently involved sites of postherpetic neuralgia. A single-center randomized controlled study was conducted to evaluate the efficacy of local methylcobalamin injection for subacute ophthalmic herpetic neuralgia (SOHN).
METHODS
One hundred and five patients with a pain score of 4 or greater were randomized to receive a combination of methylcobalamin and lidocaine via local injection (LM group, n = 35), intramuscular methylcobalamin and local lidocaine injection (IM group, n = 35), and oral methylcobalamin tablet and lidocaine local injection (OM group, n = 35) for 4 weeks. Multilevel mixed modeling was employed to examine treatment responses.
RESULTS
Pain scores were reduced in all groups, but this reduction was significantly greater in the LM group (6.7 at baseline vs. 2.8 at endpoint) when compared with systemic administration (IM group 6.8 vs. 4.9, OM group 6.7 vs. 5.1). Clinically relevant reduction of pain (>30%) was seen in 91% of patients in the LM group, a significantly greater proportion than in the systemic groups (66% IM group, 57% OM group). Analgesic use reduced significantly in the LM group (94% at baseline vs. 6% at endpoint) but not in systemic groups (IM group 97% vs. 86%, OM group 94% vs. 80%). Health-related quality of life was higher in the LM group than in the systemic groups. In mixed modelling, increased age was associated with a lower response to methylcobalamin.
CONCLUSIONS
This study indicates that local injection of methylcobalamin produces significant pain relief from SOHN and is superior to systemic administration.",2020,"RESULTS
Pain scores were reduced in all groups but this reduction was significantly greater in patients who received local methylcobalamin (6.7 at baseline vs 2.8 at endpoint) when compared with systemic administration (intramuscular 6.8 vs 4.9, oral 6.7 vs 5.1).","['Subacute Ophthalmic Herpetic Neuralgia', 'subacute ophthalmic herpetic neuralgia (SOHN', 'One hundred and five patients with a pain score of 4 or greater']","['Methylcobalamin', 'methylcobalamin', 'methylcobalamin and lidocaine via local injection (LM, N=35), intramuscular methylcobalamin and local lidocaine injection (IM, N=35), and oral methylcobalamin tablet and lidocaine local injection', 'local methylcobalamin injection']","['pain relief', 'Health-related Quality of Life', 'Analgesic', 'pain', 'Pain scores']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",105.0,0.131465,"RESULTS
Pain scores were reduced in all groups but this reduction was significantly greater in patients who received local methylcobalamin (6.7 at baseline vs 2.8 at endpoint) when compared with systemic administration (intramuscular 6.8 vs 4.9, oral 6.7 vs 5.1).","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University , Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Chao Sheng', 'Initials': 'CS', 'LastName': 'Zhou', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University , Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei Zhen', 'Initials': 'WZ', 'LastName': 'Tang', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University , Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University , Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University , Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Rehabilitation Medicine Department, Zoster-associated Pain Research Center, Affiliated Tenth People's Hospital of Tongji University , Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Li Dong', 'Initials': 'LD', 'LastName': 'Wang', 'Affiliation': ""Rehabilitation Medicine Department, Chongming Branch of Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Kai Hua', 'Initials': 'KH', 'LastName': 'Ding', 'Affiliation': ""Rehabilitation Medicine Department, Chongming Branch of Shanghai Tenth People's Hospital, Shanghai, China.""}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12909']
58,32372585,[Family risk information for colorectal cancer. Perspectives on the effectiveness of a tailored intervention],"OBJECTIVE
Information on risk levels is an essential part of the prevention of colorectal cancer (CRC). The objective of this article is to describe a tailored intervention carried out to inform the protagonists about the high risk of CRC due to family history and then to understand, through an interdisciplinary analysis, the mechanisms implemented during the intervention.
METHOD
A randomized trial design was applied. The primary outcome was the colonoscopy uptake. The intervention concerned firstly the index patients with CRC or adenoma to advise and accompany them in the transmission of information about the elevated risk for their siblings. The siblings received tailored counselling carried out by a preventive nurse, by telephone then by mail. Epidemiological, linguistic and sociological cross-analyzes were carried out to understand the impact of the intervention.
RESULTS
Colonoscopy rate was 56.3% in the intervention group, 35.4% in the control group (P = 0.0027; 304 siblings). The linguistic analysis of recorded nurse's interventions showed that, following the intervention (N = 59), the prevention themes were better assimilated while they remained vague and questioned in the discourse of the control siblings who had carried out the colonoscopy (N = 8). That was confirmed by the sociological analysis (four families) which also revealed the importance of information received from a health professional and of communication within families.
CONCLUSION
The study showed the impact of transmission of information to convince siblings at high risk of CRC to carry out colonoscopy.",2019,"RESULTS
Colonoscopy rate was 56.3% in the intervention group, 35.4% in the control group (P = 0.0027; 304 siblings).",['colorectal cancer'],"['colonoscopy', 'tailored counselling carried out by a preventive nurse, by telephone then by mail', 'tailored intervention']","['Colonoscopy rate', 'colonoscopy uptake']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]",,0.0184623,"RESULTS
Colonoscopy rate was 56.3% in the intervention group, 35.4% in the control group (P = 0.0027; 304 siblings).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ingrand', 'Affiliation': ''}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Gaussot', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Richard', 'Affiliation': ''}, {'ForeName': 'Griselda', 'Initials': 'G', 'LastName': 'Drouet', 'Affiliation': ''}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Moreau', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Ingrand', 'Affiliation': ''}]","Sante publique (Vandoeuvre-les-Nancy, France)",['10.3917/spub.197.0079']
59,32372078,Follicular-phase endometrial scratching: a truncated randomized controlled trial.,"STUDY QUESTION
Does intentional endometrial injury (scratching) during the follicular phase of ovarian stimulation (OS) increase the clinical pregnancy rate (CPR) in ART?
SUMMARY ANSWER
CPR did not vary between the endometrial injury and the control group, but the trial was underpowered due to early termination because of a higher clinical miscarriage rate observed in the endometrial injury arm after a prespecified interim analysis.
WHAT IS KNOWN ALREADY
Intentional endometrial injury has been put forward as an inexpensive clinical tool capable of enhancing endometrial receptivity. However, despite its widespread use, the benefit of endometrial scratching remains controversial, with several recent randomized controlled trials (RCTs) being unable to confirm its added value. So far, most research has focused on endometrial scratching during the luteal phase of the cycle preceding the one with embryo transfer (ET), while only a few studies investigated in-cycle injury during the follicular phase of OS. Also, the persistence of a scratch effect in subsequent treatment cycles remains unclear and possible harms have been insufficiently studied.
STUDY DESIGN, SIZE, DURATION
This RCT was performed in a tertiary hospital setting between 3 April 2014 and 8 October 2017. A total of 200 women (100 per study arm) undergoing IVF/ICSI in a GnRH antagonist suppressed cycle followed by fresh ET were included.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Participants were randomized with a 1:1 allocation ratio to either undergo a pipelle endometrial biopsy between Days 6 and 8 of OS or to be in the control group.The primary outcome was CPR. Secondary outcomes included biochemical pregnancy rate, live birth rate (LBR), early pregnancy loss (biochemical pregnancy losses and clinical miscarriages), excessive procedure pain/bleeding and cumulative reproductive outcomes within 6 months of the study cycle.
MAIN RESULTS AND THE ROLE OF CHANCE
The RCT was stopped prematurely by the trial team after the second prespecified interim analysis raised safety concerns, namely a higher clinical miscarriage rate in the intervention group. The intention-to-treat CPR was similar between the biopsy and the control arm (respectively, 44 versus 40%, P = 0.61, risk difference = 3.6 with 95% confidence interval = -10.1;17.3), as was the LBR (respectively, 32 versus 36%, P = 0.52). The incidence of a biochemical pregnancy loss was comparable between both groups (10% in the intervention group versus 15% in the control, P = 0.49), but clinical miscarriages occurred significantly more frequent in the biopsy group (25% versus 8%, P = 0.032). In the intervention group, 3% of the patients experienced excessive procedure pain and 5% bleeding. The cumulative LBR taking into account all conceptions (spontaneous or following ART) within 6 months of randomization was not significantly different between the biopsy and the control group (54% versus 60%, respectively, P = 0.43).
LIMITATIONS, REASONS FOR CAUTION
The trial was stopped prematurely due to safety concerns after the inclusion of 200 of the required 360 patients. Not reaching the predefined sample size implies that definite conclusions on the outcome parameters cannot be drawn. Furthermore, the pragmatic design of the study may have limited the detection of specific subgroups of women who may benefit from endometrial scratching.
WIDER IMPLICATIONS OF THE FINDINGS
Intentional endometrial injury during the follicular phase of OS warrants further attention in future research, as it may be harmful. These findings should be taken in consideration together with the growing evidence from other RCTs that scratching may not be beneficial.
STUDY FUNDING/COMPETING INTEREST(S)
This study was supported by 'Fonds Wetenschappelijk Onderzoek' (FWO, Flanders, Belgium, 11M9415N, 1524417N). None of the authors have a conflict of interest to declare with regard to this study.",2020,"Does intentional endometrial injury (scratching) during the follicular phase of ovarian stimulation (OS) increase the clinical pregnancy rate (CPR) in ART?
","['Intentional endometrial injury during the follicular phase of OS warrants', 'tertiary hospital setting between 3 April 2014 and 8 October 2017', '200 women (100 per study arm) undergoing IVF/ICSI in a GnRH antagonist suppressed cycle followed by fresh ET were included', 'Participants were randomized with a 1:1 allocation ratio to either undergo a pipelle endometrial biopsy between Days 6 and 8 of OS or to be in the control group', 'Follicular-phase endometrial scratching']",[],"['biochemical pregnancy rate, live birth rate (LBR), early pregnancy loss (biochemical pregnancy losses and clinical miscarriages), excessive procedure pain/bleeding and cumulative reproductive outcomes', 'clinical miscarriage rate', 'clinical pregnancy rate (CPR', 'LBR', 'cumulative LBR taking into account all conceptions (spontaneous or following ART', 'CPR', 'intention-to-treat CPR', 'incidence of a biochemical pregnancy loss', 'clinical miscarriages', 'excessive procedure pain and 5% bleeding']","[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441192', 'cui_str': 'Pipelle'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]",[],"[{'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",200.0,0.266451,"Does intentional endometrial injury (scratching) during the follicular phase of ovarian stimulation (OS) increase the clinical pregnancy rate (CPR) in ART?
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Racca', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Van de Velde', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Drakopoulos', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stoop', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blockeel', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santos-Ribeiro', 'Affiliation': 'Reproductive Medicine, IVI-RMA Lisboa, Avenida Infante Dom Henrique 333 H 1-9, 1800-282 Lisbon, Portugal.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa018']
60,32374919,Interventions for preventing venous thromboembolism in adults undergoing knee arthroscopy.,"BACKGROUND
Knee arthroscopy (KA) is a routine orthopedic procedure recommended to repair cruciate ligaments and meniscus injuries and in eligible patients, to assist the diagnosis of persistent knee pain. KA is associated with a small risk of thromboembolic events. This systematic review aims to assess if pharmacological or non-pharmacological interventions may reduce this risk. This review is the second update of the review first published in 2007.
OBJECTIVES
To assess the efficacy and safety of interventions, whether mechanical, pharmacological, or in combination, for thromboprophylaxis in adult patients undergoing KA.
SEARCH METHODS
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, the CENTRAL, MEDLINE, Embase and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 14 August 2019.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and controlled clinical trials (CCTs), whether blinded or not, of all types of interventions used to prevent deep vein thrombosis (DVT) in males and females aged 18 years and older undergoing KA. There were no restrictions on language or publication status.
DATA COLLECTION AND ANALYSIS
Two authors independently selected studies for inclusion, assessed trial quality with the Cochrane 'Risk of bias' tool, and extracted data. A third author addressed discrepancies. We contacted study authors for additional information when required. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
This update adds four new studies, bringing the total of included studies to eight and involving 3818 adult participants with no history of thromboembolic disease undergoing KA. Studies compared daily subcutaneous (sc) low-molecular-weight heparin (LMWH) versus control (five studies); oral rivaroxaban 10 mg versus placebo (one study); daily sc LMWH versus graduated compression stockings (GCS) (one study); and aspirin versus control (one study). The incidence of pulmonary embolism (PE) in all trials combined was low, with seven cases in 3818 participants.There were no deaths in any of the intervention or control groups. LMWH versus control When compared with control, LMWH probably results in little to no difference in the incidence of PE in patients undergoing KA (risk ratio (RR) 1.81, 95% confidence interval (CI) 0.49 to 6.65; 1820 participants; 3 studies; moderate-certainty evidence). LMWH showed no reduction of the incidence of symptomatic DVT (RR 0.61, 95% CI 0.18 to 2.03; 1848 participants; 4 studies; moderate-certainty evidence). LMWH may reduce the risk of asymptomatic DVT but the evidence is very uncertain (RR 0.14, 95% CI 0.03 to 0.61; 369 participants; 2 studies; very low-certainty evidence). There was no evidence of an increased risk of all adverse events combined (RR 1.85, 95% CI 0.95 to 3.59; 1978 participants; 5 studies; moderate-certainty evidence). No evidence of a clear effect on major bleeding (RR 0.98, 95% CI 0.06 to 15.72; 1451 participants; 1 study; moderate-certainty evidence), or minor bleeding was observed (RR 1.79, 95% CI 0.84 to 3.84; 1978 participants; 5 studies; moderate-certainty evidence). Rivaroxaban versus placebo One study with 234 participants compared oral rivaroxaban 10 mg versus placebo. No evidence of a clear impact on the risk of PE (no events in either group), symptomatic DVT (RR 0.16, 95% CI 0.02 to 1.29; moderate-certainty evidence); or asymptomatic DVT (RR 0.95, 95% CI 0.06 to 15.01; very low-certainty evidence) was detected. Only bleeding adverse events were reported. No major bleeds occurred in either group and there was no evidence of differences in minor bleeding between the groups (RR 0.63, 95% CI 0.18 to 2.19; moderate-certainty evidence). Aspirin versus control One study compared aspirin with control. No PE, DVT or asymptomatic events were detected in either group. Adverse events including pain and swelling were reported but it was not clear what groups these were in. No bleeds were reported. LMWH versus GCS One study with 1317 participants compared the use of LMWH versus GCS. There was no clear difference in the risk of PE (RR 1.00, 95% CI 0.14 to 7.05; low-certainty evidence). LMWH use did reduce the risk of DVT compared to people using GCS (RR 0.17, 95% CI 0.04 to 0.75; low-certainty evidence). No clear difference in effects was seen between the groups for asymptomatic DVT (RR 0.47, 95% CI 0.21 to 1.09; very low-certainty evidence); major bleeding (RR 3.01, 95% CI 0.61 to 14.88; moderate-certainty evidence) or minor bleeding (RR 1.16, 95% CI 0.64 to 2.08; moderate-certainty evidence). Levels of thromboembolic events were higher in the GCS group than in any other group. We downgraded the certainty of the evidence for imprecision resulting from overall small event numbers; risk of bias due to concerns about lack of blinding, and indirectness as we were uncertain about the direct clinical relevance of asymptomatic DVT detection.
AUTHORS' CONCLUSIONS
There is a small risk that healthy adult patients undergoing KA will develop venous thromboembolism (PE or DVT). There is moderate- to low-certainty evidence of no benefit from the use of LMWH, aspirin or rivaroxaban in reducing this small risk of PE or symptomatic DVT. There is very low-certainty evidence that LMWH use may reduce the risk of asymptomatic DVT when compared to no treatment but it is uncertain how this directly relates to incidence of DVT or PE in healthy patients. No evidence of differences in adverse events (including major and minor bleeding) was seen, but data relating to this were limited due to low numbers of events in the studies reporting within the comparisons.",2020,"No major bleeds occurred in either group and there was no evidence of differences in minor bleeding between the groups (RR 0.63, 95% CI 0.18 to 2.19; moderate-certainty evidence).","['healthy patients', 'males and females aged 18 years and older undergoing KA', 'adults undergoing knee arthroscopy', 'healthy adult patients undergoing', '3818 participants', '234 participants compared', 'adult patients undergoing KA', '3818 adult participants with no history of thromboembolic disease undergoing KA', '1317 participants']","['daily subcutaneous (sc) low-molecular-weight heparin (LMWH) versus control (five studies); oral rivaroxaban', 'Knee arthroscopy (KA', 'LMWH versus GCS', 'LMWH', 'KA', 'oral rivaroxaban', 'LMWH, aspirin or rivaroxaban', 'LMWH versus graduated compression stockings (GCS', 'Rivaroxaban', 'aspirin', 'GCS', 'Aspirin versus control', 'placebo']","['Levels of thromboembolic events', 'minor bleeding', 'risk of PE', 'language or publication status', 'moderate-certainty evidence) or minor bleeding', 'risk of asymptomatic DVT', 'PE, DVT or asymptomatic events', 'pain and swelling', 'venous thromboembolism', 'asymptomatic DVT', 'adverse events', 'major bleeds', 'risk of all adverse events', 'major bleeding', 'bleeding', 'incidence of symptomatic DVT', 'incidence of PE', 'bleeding adverse events', 'deep vein thrombosis (DVT', 'symptomatic DVT', 'incidence of pulmonary embolism (PE', 'risk of DVT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee joint'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee joint'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",3818.0,0.454682,"No major bleeds occurred in either group and there was no evidence of differences in minor bleeding between the groups (RR 0.63, 95% CI 0.18 to 2.19; moderate-certainty evidence).","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Perrotta', 'Affiliation': 'School of Public Health, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Chahla', 'Affiliation': 'Center for Regenerative Sports Medicine (CRSM), Vail, Colorado, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Badariotti', 'Affiliation': 'Internal Medicine, Sanatorio Mater Dei, Buenos Aires, Argentina.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Ramos', 'Affiliation': 'Department of Orthopedics, Hospital Británico de Buenos Aires, Buenos Aires, Argentina.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD005259.pub4']
61,32349260,Impact of Combined Theory-Based Intervention on Psychological Effects and Physical Activity among Chinese Adolescents.,"PURPOSE
The current study was intended to assess the effect of a facilitated behavioral intervention based on the extended theory of planned behavior (TPB) on psychological constructs and physical activity among adolescents over a period of eight weeks.
METHODS
Students ( n = 51, 12 ± 0.3 years of age) in the seventh grade at a junior middle school in China were randomly assigned to two groups: the intervention group ( n = 24) and the control group ( n = 27). Both groups were pre- and post-tested with the related psychological constructs of the extended TPB, along with behavioral measures of the Physical Activity Scale and ActiGraph accelerometer (model wGT3X-BT). The intervention group took part in 45 min classes once per week for 8 weeks, including five indoor theoretical courses and three outdoor basketball matches. The control group was not required to make any change to their normal school day. Also, 2 × 2 repeated measures analysis of variance (ANOVA) was conducted to compare the differences between the two groups, and then t -test was employed to compare the independent and paired differences.
RESULTS
Significant increases in pre-post subjective norms (SN) ( p = 0.041, Cohen's d = 0.62), perceived behavior control (PBC) ( p = 0.023, Cohen's d = 0.72), exercise intention (EI) ( p = 0.043, Cohen's d = 0.61), and self-efficacy (SE) ( p = 0.035, Cohen's d = 1.36) were observed in the intervention group. In addition, participants in the intervention group increased their exercise frequency ( p < 0.001, Cohen's d = 1.25) and intensity ( p = 0.028, Cohen's d = 0.68), especially their time spent on light intensity physical activity (light-PA%; p = 0.031, Cohen's d = 0.68), and their percentage of sedentary time (SB%) was also reduced (from 68% ± 10% to 58% ± 7%, p < 0.001, Cohen's d = 1.17). Furthermore, the intervention group showed significantly better performance in PBC ( p = 0.032, Cohen's d = 0.62), EI ( p < 0.001, Cohen's d = 1.32), SE ( p < 0.001, Cohen's d = 1.15), SB% ( p < 0.001, Cohen's d = 1.22), light-PA% ( p < 0.001, Cohen's d = 1.12), and total physical activity (TPA) ( p = 0.015, Cohen's d = 0.72) compared to the control group at the post-test. No significant pre post differences were observed for any psychological or behavioral variables in the control group, except for exercise frequency, but the values were still lower than those in the intervention group after the 8-week intervention (3.70 ± 0.72 versus 3.92 ± 0.83).
CONCLUSION
The combined theory-based intervention was effective at improving psychological constructs and physical activity among seventh-grade adolescents in 8 weeks.",2020,"No significant pre post differences were observed for any psychological or behavioral variables in the control group, except for exercise frequency, but the values were still lower than those in the intervention group after the 8-week intervention (3.70 ± 0.72 versus 3.92 ± 0.83).
","['Chinese Adolescents', 'Students ( n = 51, 12 ± 0.3 years of age) in the seventh grade at a junior middle school in China', 'adolescents over a period of eight weeks']","['planned behavior (TPB', 'facilitated behavioral intervention', 'Combined Theory-Based Intervention']","['SB', 'perceived behavior control (PBC', 'exercise frequency', 'time spent on light intensity physical activity', 'psychological constructs and physical activity', 'performance in PBC', 'pre-post subjective norms (SN', 'percentage of sedentary time (SB', 'light-PA', 'total physical activity (TPA', 'exercise intention (EI', 'Physical Activity Scale and ActiGraph accelerometer (model wGT3X-BT', 'self-efficacy (SE', 'psychological or behavioral variables', 'Psychological Effects and Physical Activity']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376287', 'cui_str': 'Behavioral Manipulation'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0277631,"No significant pre post differences were observed for any psychological or behavioral variables in the control group, except for exercise frequency, but the values were still lower than those in the intervention group after the 8-week intervention (3.70 ± 0.72 versus 3.92 ± 0.83).
","[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Sports Science & Physical Education, Tsinghua University, Qinghuayuan street, Haidian district, Beijing 100084, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Division of Sports Science & Physical Education, Tsinghua University, Qinghuayuan street, Haidian district, Beijing 100084, China.'}, {'ForeName': 'Jianxiu', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Sports Science & Physical Education, Tsinghua University, Qinghuayuan street, Haidian district, Beijing 100084, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Division of Sports Science & Physical Education, Tsinghua University, Qinghuayuan street, Haidian district, Beijing 100084, China.'}, {'ForeName': 'Zeshi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Division of Sports Science & Physical Education, Tsinghua University, Qinghuayuan street, Haidian district, Beijing 100084, China.'}, {'ForeName': 'Xindong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Division of Sports Science & Physical Education, Tsinghua University, Qinghuayuan street, Haidian district, Beijing 100084, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17093026']
62,32350749,A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug-Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy.,"BACKGROUND
In recent randomized, placebo-controlled, phase III trials, highly purified cannabidiol demonstrated efficacy with an acceptable safety profile in patients with Lennox-Gastaut syndrome or Dravet syndrome. It is anticipated that antiepileptic drugs such as stiripentol and valproate will be administered concomitantly with cannabidiol.
OBJECTIVES
This trial evaluated the effect of cannabidiol on steady-state pharmacokinetics of stiripentol or valproate in patients with epilepsy, and the safety and tolerability of cannabidiol.
METHODS
This phase II, two-arm, parallel-group, double-blind, randomized, placebo-controlled trial recruited male and female patients with epilepsy aged 16-55 years. Patients receiving a stable dose of stiripentol or valproate were randomized 4:1 to receive concomitant double-blind cannabidiol or placebo. Patients received plant-derived, highly purified cannabidiol medicine (Epidiolex ® in the USA; Epidyolex ® in the EU; 100 mg/mL oral solution) at a dose of 20 mg/kg/day from day 12 to 26, following a 10-day dose-escalation period. Blood samples for pharmacokinetic evaluations were collected on days 1 and 26 before stiripentol/valproate dosing and up to 12 h postdose. Treatment-emergent adverse events (AEs) were recorded.
RESULTS
In total, 35 patients were recruited to the stiripentol arm (n = 14) or the valproate arm (n = 21). Both the safety and the pharmacokinetic populations of the stiripentol arm comprised 14 patients (2 placebo; 12 cannabidiol). The safety population of the valproate arm comprised 20 patients (4 placebo; 16 cannabidiol; one withdrew before receiving treatment); the pharmacokinetic population comprised 15 patients (3 placebo; 12 cannabidiol). Concomitant cannabidiol led to a small increase in stiripentol exposure (17% increase in maximum observed plasma concentration [C max ]; 30% increase in area under the concentration-time curve over the dosing interval [AUC tau ]). Concomitant cannabidiol also had little effect on valproate exposure (13% decrease in C max ; 17% decrease in AUC tau ) or its metabolite, 2-propyl-4-pentenoic acid (4-ene-VPA) (23% decrease in C max ; 30% decrease in AUC tau ). All changes in exposure are expressed as the dose-normalized geometric mean (CV%) day 26 to day 1 ratio. The most common AE was diarrhea; most AEs were mild. Two patients discontinued cannabidiol because of serious AEs (rash [n = 1] in the stiripentol arm; hypertransaminasemia [n = 1] in the valproate arm). A separate in vitro study investigated the bidirectional effect of cannabidiol, or its metabolite 7-carboxy-cannabidiol, on valproate plasma protein binding; no change in plasma protein binding was observed for either compound.
CONCLUSIONS
The clinical relevance of the increase in stiripentol exposure is unknown; patients receiving cannabidiol and stiripentol concomitantly should be monitored for adverse reactions as individual patient responses may vary. Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy. Safety results were consistent with the known safety profile of cannabidiol at a dose of 20 mg/kg/day. Clinicaltrials.gov: NCT02607891.",2020,"Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy.","['Patients receiving a stable dose of', 'controlled trial recruited male and female patients with epilepsy aged 16-55 years', '20 patients (4', 'patients with epilepsy', 'adult patients with epilepsy', 'In total,\xa035 patients were recruited to the stiripentol arm (n = 14) or the valproate arm (n = 21', 'Patients with Epilepsy', 'patients with Lennox-Gastaut syndrome or Dravet syndrome']","['concomitant double-blind cannabidiol or placebo', 'placebo', 'valproate', 'Stiripentol or Valproate', 'plant-derived, highly purified cannabidiol medicine (Epidiolex ® in the USA; Epidyolex ® in the EU; 100 mg/mL oral solution', 'stiripentol or valproate']","['stiripentol exposure', 'valproate exposure', 'AUC tau ) or its metabolite, 2-propyl-4-pentenoic acid (4-ene-VPA', 'plasma protein binding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4731581', 'cui_str': 'Epidiolex'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0046536', 'cui_str': '2-propyl-4-pentenoic acid'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",35.0,0.419758,"Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy.","[{'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Ben-Menachem', 'Affiliation': 'Department of Clinical Neuroscience at Institute of Neuroscience and Physiology, Neurologen, University of Gothenburg, Blå Stråket 7, Plan 0, 41345, Gothenburg, Sweden. elinor.ben-menachem@neuro.gu.se.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, The Netherlands.'}, {'ForeName': 'Carmen María', 'Initials': 'CM', 'LastName': 'Arenas Cabrera', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'Kevan', 'Initials': 'K', 'LastName': 'VanLandingham', 'Affiliation': 'Greenwich Biosciences, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Crockett', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Critchley', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Wray', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Toledo', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}]",CNS drugs,['10.1007/s40263-020-00726-4']
63,32349359,Effectiveness of the Reasoning and Rehabilitation V2 Programme for Improving Personal and Social Skills in Spanish Adolescent Students.,"Significant progress has been made in developing intervention programmes for adolescents at high risk of delinquency, school failure and emotional problems. The most effective programmes incorporate behavioural and skills training aimed at changing attitudes and promoting psychosocial and emotional skills in adolescents. This study examined the effectiveness of a school-based intervention programme based on the Reasoning and Rehabilitation V2 (R&R2). R&R2 is a cognitive behavioural programme developed using psychological theories about the aetiology of delinquency, as well as the cognitive, behavioural and socioemotional deficits in high-risk youth populations. A sample of 142 students (aged 13-17 years old) who were attending alternative education provision in Spain were randomly assigned to two experimental conditions (68 experimental group, 74 control group). The results showed that the R&R2 improved participants' self-esteem, social skills, empathy and rational problem-solving with a medium-large effect size (η2 = 0.08 to 0.26). The effects of the programme were significant after controlling for age and the pre-test scores in baseline. These findings confirm the effectiveness of the Reasoning and Rehabilitation V2 programme in Spanish adolescent students and offer additional evidence regarding the implementation of the R&R2 programme in both alternative educational and mainstream school settings.",2020,"The results showed that the R&R2 improved participants' self-esteem, social skills, empathy and rational problem-solving with a medium-large effect size (η2 = 0.08 to 0.26).","['142 students (aged 13-17 years old) who were attending alternative education provision in Spain', 'Spanish Adolescent Students', 'Spanish adolescent students', 'adolescents at high risk of delinquency, school failure and emotional problems', 'adolescents']","['Reasoning and Rehabilitation V2 Programme', 'R&R2', 'school-based intervention programme']","['Personal and Social Skills', ""R&R2 improved participants' self-esteem, social skills, empathy and rational problem-solving with a medium-large effect size""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0022438', 'cui_str': 'Juvenile Delinquency'}, {'cui': 'C0681374', 'cui_str': 'Academic Failure'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",142.0,0.0212119,"The results showed that the R&R2 improved participants' self-esteem, social skills, empathy and rational problem-solving with a medium-large effect size (η2 = 0.08 to 0.26).","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Sánchez-SanSegundo', 'Affiliation': 'Department of Health Psychology, Faculty of Health Science, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Ferrer-Cascales', 'Affiliation': 'Department of Health Psychology, Faculty of Health Science, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Albaladejo-Blazquez', 'Affiliation': 'Department of Health Psychology, Faculty of Health Science, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Alarcó-Rosales', 'Affiliation': 'Department of Health Psychology, Faculty of Health Science, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bowes', 'Affiliation': 'Cardiff School of Sport and Health Sciences, University of Cardiff, Cardiff CF23 6XD, UK.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Ruiz-Robledillo', 'Affiliation': 'Department of Health Psychology, Faculty of Health Science, University of Alicante, 03690 Alicante, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17093040']
64,32353342,"Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial.","BACKGROUND
Patients with HER2-positive breast cancer who have received two or more previous therapies for advanced disease have few effective treatment options. The monarcHER trial aimed to compare the efficacy of abemaciclib plus trastuzumab with or without fulvestrant with standard-of-care chemotherapy of physician's choice plus trastuzumab in women with advanced breast cancer.
METHODS
This phase 2, three-group, open-label trial was done across 75 hospitals, clinics, and medical centres in 14 countries. Eligible patients were women aged 18 years or older, who had hormone receptor-positive, HER2-positive advanced breast cancer with unresectable, locally advanced, recurrent or metastatic disease, Eastern Cooperative Oncology Group performance status of 0 or 1, and who had previously received at least two HER2-targeted therapies for advanced disease. Patients were randomly assigned 1:1:1 to the abemaciclib, trastuzumab, and fulvestrant (group A), abemaciclib and trastuzumab (group B), or standard-of-care chemotherapy and trastuzumab (group C). Oral abemaciclib 150 mg 12 hourly was administered on days 1-21 of a 21-day cycle, intravenous trastuzumab 8 mg/kg on cycle 1 day 1, followed by 6 mg/kg on day 1 of each subsequent 21-day cycle, and intramuscular fulvestrant 500 mg on days 1, 15, and 29 and once every 4 weeks thereafter. Standard-of-care chemotherapy was administered as specified by the product label. Randomisation was by a computer-generated random sequence by means of an interactive web-response system and stratified by number of previous systemic therapies for advanced breast cancer and measurable versus non-measurable disease. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population, first testing group A versus group C and, if this result was significant, then group B versus group C. Safety was assessed in all patients who had received at least one dose of study treatment. This trial is registered at ClinicalTrials.gov (NCT02675231) and is ongoing for long-term survival follow-up.
FINDINGS
Between May 31, 2016, and Feb 28, 2018, 325 patients were screened, of whom 237 eligible patients were enrolled and randomly assigned to groups A (n=79), B (n=79), and C (n=79). Median follow-up was 19·0 months (IQR 14·7-25·1). The study met its primary endpoint, showing a significant difference at the prespecified two-sided α of 0·2 in median progression-free survival between group A (8·3 months, 95% CI 5·9-12·6) and group C (5·7 months, 5·4-7·0; HR 0·67 [95% CI 0·45-1·00]; p=0·051). No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77). The most common grade 3-4 treatment-emergent adverse event in groups A, B, and C was neutropenia (21 [27%] of 78 patients, 17 [22%] of 77, and 19 [26%] of 72). The most common serious adverse events were: in group A, pyrexia (three [4%]), diarrhoea (two [3%]), urinary tract infection (two [3%]), and acute kidney injury (two [3%]); in group B, diarrhoea (two [3%]) and pneumonitis (two [3%]); and in group C, neutropenia (four [6%]) and pleural effusion (two [3%]). Two deaths were attributed to treatment: one due to pulmonary fibrosis in group B and one due to febrile neutropenia in group C.
INTERPRETATION
The combination of abemaciclib, fulvestrant, and trastuzumab significantly improved progression-free survival versus standard-of-care chemotherapy plus trastuzumab while showing a tolerable safety profile. Our results suggest that a chemotherapy-free regimen might potentially be an alternative treatment option for patients with hormone receptor-positive, HER2-positive advanced breast cancer.
FUNDING
Eli Lilly and Company.",2020,"No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77).","['women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER', '75 hospitals, clinics, and medical centres in 14 countries', 'patients with hormone receptor-positive, HER2-positive advanced breast cancer', 'Patients with HER2-positive breast cancer', 'Between May 31, 2016, and Feb 28, 2018, 325 patients were screened, of whom 237 eligible patients', 'women with advanced breast cancer', 'Eligible patients were women aged 18 years or older, who had hormone receptor-positive, HER2-positive advanced breast cancer with unresectable, locally advanced, recurrent or metastatic disease, Eastern Cooperative Oncology Group performance status of 0 or 1, and who had previously received at least two HER2-targeted therapies for advanced disease']","['Standard-of-care chemotherapy', ""abemaciclib plus trastuzumab with or without fulvestrant with standard-of-care chemotherapy of physician's choice plus trastuzumab"", 'Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy', 'Oral abemaciclib', 'abemaciclib, trastuzumab, and fulvestrant (group A), abemaciclib and trastuzumab (group B), or standard-of-care chemotherapy and trastuzumab']","['pneumonitis', 'febrile neutropenia', 'neutropenia', 'median progression-free survival', 'progression-free survival', 'acute kidney injury', 'diarrhoea', 'pyrexia', 'urinary tract infection', 'pleural effusion', 'investigator-assessed progression-free survival']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",325.0,0.211064,"No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77).","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: sara_tolaney@dfci.harvard.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Wardley', 'Affiliation': 'The NIHR Manchester Clinical Research Facility at The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Zambelli', 'Affiliation': 'Istituto Di Ricovero e Cura a Carattere Scientifico, Ospedale San Raffaele, IRCCS, Milano, Italy.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Hilton', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Troso-Sandoval', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Institut Curie, PSL Research University, Department of Medical Oncology, Paris, France.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Stephen Rd', 'Initials': 'SR', 'LastName': 'Johnston', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-WA, Nedlands, WA, Australia; Curtin University, Nedlands, WA, Australia.'}, {'ForeName': 'Shom', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; The Sir Peter MacCallum Department of Medical Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Catron', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Sonya C', 'Initials': 'SC', 'LastName': 'Chapman', 'Affiliation': 'Eli Lilly, Windlesham, UK.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Price', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'M Corona', 'Initials': 'MC', 'LastName': 'Gainford', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Gustave Roussy, Université Paris Saclay, INSERM, Villejuif, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30112-1']
65,32354051,Developing and Evaluating an Educational Program for Respiratory Infection Prevention among Rural Elderly Residents in South Korea.,"Based on social cognitive theory (SCT), an educational program was developed to prevent rural elderly residents from respiratory infections in South Korea. The effectiveness of the program was investigated in terms of knowledge, attitudes, and practices about respiratory infection prevention, as well as social capital. A pretest-posttest nonequivalent control group quasi-experimental design was used to test the short-term effect of this program. In addition, 1- and 6-month follow-up surveys were administered to evaluate the long-term effects. A total of 69 subjects (37 in the experimental group and 32 in the control group) participated in the experiment. The results showed that knowledge about respiratory infection prevention, respiratory infection prevention practices, and social capital were enhanced among the elderly residents who participated in the educational program. The educational effects differed significantly across time periods (pretest, posttest, 1- and 6-month follow up) in all the above variables. In particular, the program remained effective 1 month after the intervention, but a reinforcement session extended the program's effects up to 6 months later. This educational program would be used as an effective intervention to help rural elderly residents prevent respiratory infections.",2020,"The results showed that knowledge about respiratory infection prevention, respiratory infection prevention practices, and social capital were enhanced among the elderly residents who participated in the educational program.","['rural elderly residents prevent respiratory infections', 'rural elderly residents from respiratory infections in South Korea', 'Rural Elderly Residents in South Korea', '69 subjects (37 in the experimental group and 32 in the control group) participated in the experiment', 'elderly residents who participated in the educational program']","['Educational Program', 'social cognitive theory (SCT']","['knowledge about respiratory infection prevention, respiratory infection prevention practices, and social capital']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}]",69.0,0.0112395,"The results showed that knowledge about respiratory infection prevention, respiratory infection prevention practices, and social capital were enhanced among the elderly residents who participated in the educational program.","[{'ForeName': 'Jin Soon', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Dang-Rim Primary Health Care Post, Chuncheon Public Health Center, Gangwon-do 24463, Chuncheon-si, Korea.'}, {'ForeName': 'Ji Hye', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Health and New Media Research Institute, Hallym University, Gangwon-do 24252, Chuncheon-si, Korea.'}, {'ForeName': 'Myung Soon', 'Initials': 'MS', 'LastName': 'Kwon', 'Affiliation': 'School of Nursing, Research Institute of Nursing Science, Hallym University, Gangwon-do 24252, Chuncheon-si, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17093057']
66,32354671,"HPV vaccine uptake among daughters of Latinx immigrant mothers: Findings from a cluster randomized controlled trial of a community-based, culturally relevant intervention.","OBJECTIVE
We examined the efficacy of a culturally relevant, community-based HPV vaccination intervention among Latinx immigrant mothers with daughters aged 9-12 in Alabama.
METHODS
We conducted a cluster-randomized controlled trial with ""place of residence"" (e.g., apartment complexes, trailer parks) as the unit of randomization that evaluated two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating and appropriate nutrition label interpretation. Identical baseline/post/7-month follow up questionnaires were completed by all participants and both interventions consisted of four group sessions and one individual session. A total of 40 locations were randomized with 317 mother-daughter dyads enrolled in the study between May 2013 and October 2017.
RESULTS
A total of 278 mother-daughter dyads met full eligibility and initiated the intervention/control participation. Retention rate overall was 93.2% (92.6% for the intervention arm and 93.7% for the control arm). Daughters in the intervention arm were significantly more likely to receive one, two, and three doses of HPV vaccine than daughters in the control arm p < 0.001). In multivariate analyses, mothers in the intervention arm had a six times greater odds of vaccinating daughters with the first dose (OR = 5.96, 95% CI: 3.38, 10.49), eight times greater odds of vaccinating daughters with the second dose (OR = 8.09, 95% CI: 4.0, 16.35), and more than 16 times greater odds of completing the three-dose HPV vaccine series than mothers in the control arm after adjusting for mother's age, time in the U.S., income, and daughter's health insurance status (OR = 16.5, 95% CI: 5.73, 47.48). Only perceived risk of their daughters' future HPV infection remained significant as a predictor of three-dose HPV vaccination completion (OR = 0.69, 95% CI: 0.23, 2.1).
CONCLUSIONS
A theory-driven, culturally-relevant intervention developed through extensive formative assessments in collaboration with community members can effectively promote HPV vaccination among 9-12 years of age daughters of Latina immigrants.",2020,"Only perceived risk of their daughters' future HPV infection remained significant as a predictor of three-dose HPV vaccination completion (OR = 0.69, 95% CI: 0.23, 2.1).
","['9-12\xa0years of age daughters of Latina immigrants', 'Latinx immigrant mothers with daughters aged 9-12 in Alabama', 'A total of 40 locations were randomized with 317 mother-daughter dyads enrolled in the study between May 2013 and October 2017', 'daughters of Latinx immigrant mothers', '278 mother-daughter dyads met full eligibility and initiated the intervention/control participation']","['HPV vaccination and 2) promotion of healthy eating and appropriate nutrition label interpretation', 'culturally relevant, community-based HPV vaccination intervention', 'HPV vaccine']","['Retention rate overall', 'HPV vaccine uptake']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}]",40.0,0.112342,"Only perceived risk of their daughters' future HPV infection remained significant as a predictor of three-dose HPV vaccination completion (OR = 0.69, 95% CI: 0.23, 2.1).
","[{'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Scarinci', 'Affiliation': 'University of Alabama at Birmingham, Division of Preventive Medicine, 1717 11th Ave South, Birmingham, AL 35205, United States. Electronic address: scarinci@uab.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'University of Alabama at Birmingham, Division of Preventive Medicine, 1717 11th Ave South, Birmingham, AL 35205, United States. Electronic address: barbarahansen@uabmc.edu.'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'University of Alabama at Birmingham, Division of Preventive Medicine, 1717 11th Ave South, Birmingham, AL 35205, United States. Electronic address: youngkim@uabmc.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.03.052']
67,32356244,Ranibizumab Pretreatment in Vitrectomy with Internal Limiting Membrane Peeling on Diabetic Macular Edema in Severe Proliferative Diabetic Retinopathy.,"AIM
To evaluate the efficacy of intravitreal ranibizumab (IVR) pretreatment for pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling in severe proliferative diabetic retinopathy (PDR) combined with macular edema (ME).
METHODS
Sixty-three patients with ME and PDR were divided into IVR and control groups. Three days before PPV stripping, ranibizumab was injected into the patients in the IVR group. The patients were followed for 6 months. The best-corrected visual acuity (BCVA), visual acuity improvement, centre macular thickness (CMT), and intraoperative and postoperative complications were compared between the two groups.
RESULTS
The BCVA of the IVR group was significantly improved at 1, 3 and 6 months compared with the preoperative BCVA (P < 0.01). The BCVA of the control group was significantly improved at 3 and 6 months compared with the preoperative BCVA (P < 0.01), but was not significantly improved at 1 month. At 1 and 3 months, the BCVA of the IVR group was significantly better than that of the control group after surgery, with no difference between the two groups at 6 months. The CMT of the IVR group was thinner than that of the control group at 1 and 3 months (P < 0.01), with no significant difference at 6 months after surgery. The surgical time, the risk of intraoperative bleeding, the incidence of iatrogenic retinal breaks, the frequency of endodiathermy and the rate of silicone oil tamponade were significantly different between the two groups (all P < 0.05). There was no significant difference between the two groups in terms of postoperative complications.
CONCLUSIONS
Ranibizumab pretreatment may improve the outcome of PPV with ILM peeling for severe PDR with ME by decreasing ME and intraoperative complications.",2020,"At 1 and 3 months, the BCVA of the IVR group was significantly better than that of the control group after surgery, with no difference between the two groups at 6 months.","['severe proliferative diabetic retinopathy (PDR) combined with macular edema (ME', 'Sixty-three patients with ME and PDR', 'Severe Proliferative Diabetic Retinopathy']","['Vitrectomy with Internal Limiting Membrane Peeling', 'pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling', 'Ranibizumab', 'intravitreal ranibizumab (IVR', 'PPV stripping, ranibizumab']","['Diabetic Macular Edema', 'best-corrected visual acuity (BCVA), visual acuity improvement, centre macular thickness (CMT), and intraoperative and postoperative complications', 'surgical time, the risk of intraoperative bleeding, the incidence of iatrogenic retinal breaks, the frequency of endodiathermy and the rate of silicone oil tamponade', 'postoperative complications', 'BCVA']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035321', 'cui_str': 'Retinal tear'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]",63.0,0.0259205,"At 1 and 3 months, the BCVA of the IVR group was significantly better than that of the control group after surgery, with no difference between the two groups at 6 months.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Cai', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Liu', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Ning-Ning', 'Initials': 'NN', 'LastName': 'Liu', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China. ningning1688@126.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00822-0']
68,32297590,Rigorous Randomized Controlled Trial Implementation in the Era of COVID-19.,,2020,Rigorous Randomized Controlled Trial Implementation in the Era of Novel Coronavirus Disease (COVID-19).,[],[],[],[],[],[],,0.195176,Rigorous Randomized Controlled Trial Implementation in the Era of Novel Coronavirus Disease (COVID-19).,"[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0262']
69,32356772,Improving Hand Hygiene Compliance in Nursing Homes: Protocol for a Cluster Randomized Controlled Trial (HANDSOME Study).,"BACKGROUND
Hand hygiene compliance is considered the most (cost-)effective measure for preventing health care-associated infections. While hand hygiene interventions have frequently been implemented and assessed in hospitals, there is limited knowledge about hand hygiene compliance in other health care settings and which interventions and implementation methods are effective.
OBJECTIVE
This study aims to evaluate the effect of a multimodal intervention to increase hand hygiene compliance of nurses in nursing homes through a cluster randomized controlled trial (HANDSOME study).
METHODS
Nursing homes were randomly allocated to 1 of 3 trial arms: receiving the intervention at a predetermined date, receiving the identical intervention after an infectious disease outbreak, or serving as a control arm. Hand hygiene was evaluated in nursing homes by direct observation at 4 timepoints. We documented compliance with the World Health Organization's 5 moments of hand hygiene, specifically before touching a patient, before a clean/aseptic procedure, after body fluid exposure risk, after touching a patient, and after touching patient surroundings. The primary outcome is hand hygiene compliance of the nurses to the standards of the World Health Organization. The secondary outcome is infectious disease incidence among residents. Infectious disease incidence was documented by a staff member at each nursing home unit. Outcomes will be compared with the presence of norovirus, rhinovirus, and Escherichia coli on surfaces in the nursing homes, as measured using quantitative polymerase chain reaction.
RESULTS
The study was funded in September 2015. Data collection started in October 2016 and was completed in October 2017. Data analysis will be completed in 2020.
CONCLUSIONS
HANDSOME studies the effectiveness of a hand hygiene intervention specifically for the nursing home environment. Nurses were taught the World Health Organization's 5 moments of hand hygiene guidelines using the slogan ""Room In, Room Out, Before Clean, After Dirty,"" which was developed for nursing staff to better understand and remember the hygiene guidelines. HANDSOME should contribute to improved hand hygiene practice and a reduction in infectious disease rates and related mortality.
TRIAL REGISTRATION
Netherlands Trial Register (NTR6188) NL6049; https://www.trialregister.nl/trial/6049.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/17419.",2020,"Outcomes will be compared with the presence of norovirus, rhinovirus, and Escherichia coli on surfaces in the nursing homes, as measured using quantitative polymerase chain reaction.
","['Nursing Homes', 'nurses in nursing homes', 'Nursing homes']","['slogan ', 'multimodal intervention']","['infectious disease incidence', 'Infectious disease incidence', 'hand hygiene compliance of the nurses to the standards of the World Health Organization']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]",,0.179883,"Outcomes will be compared with the presence of norovirus, rhinovirus, and Escherichia coli on surfaces in the nursing homes, as measured using quantitative polymerase chain reaction.
","[{'ForeName': 'Gwen R', 'Initials': 'GR', 'LastName': 'Teesing', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Erasmus', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Petrignani', 'Affiliation': 'Municipal Public Health Service Haaglanden, Den Haag, Netherlands.'}, {'ForeName': 'Marion P G', 'Initials': 'MPG', 'LastName': 'Koopmans', 'Affiliation': 'Department of Viroscience, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'de Graaf', 'Affiliation': 'Department of Viroscience, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Margreet C', 'Initials': 'MC', 'LastName': 'Vos', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Corné H W', 'Initials': 'CHW', 'LastName': 'Klaassen', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Verduijn-Leenman', 'Affiliation': 'Pieter van Foreest, Delft, Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research and Department of Family Medicine, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Jan Hendrik', 'Initials': 'JH', 'LastName': 'Richardus', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Helene A C M', 'Initials': 'HACM', 'LastName': 'Voeten', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.'}]",JMIR research protocols,['10.2196/17419']
70,32356774,Effectiveness of a Quit Vaping Text Message Program in Promoting Abstinence Among Young Adult E-Cigarette Users: Protocol for a Randomized Controlled Trial.,"BACKGROUND
Millions of young adults currently vape electronic cigarettes (e-cigarettes), yet little research on vaping cessation interventions exists. Text messaging is a promising, scalable intervention strategy for delivering vaping cessation treatment.
OBJECTIVE
This study evaluates the effectiveness of a text message quit vaping program (This is Quitting) in promoting abstinence from e-cigarettes among young adults; examines changes in self-efficacy, perceived social norms, and social support for quitting as hypothesized mediators of effectiveness; and examines if treatment effectiveness is moderated by gender, race, ethnicity, or sexual minority status.
METHODS
Overall, 2600 young adult (aged 18-24 years) e-cigarette users in the United States will be recruited via web advertisements to participate in the study. Participants will be randomized to This is Quitting or an assessment-only control condition. The primary outcome measure is 30-day vaping abstinence at 7 months post enrollment.
RESULTS
Study recruitment began on December 18, 2019, and is projected to be completed by spring 2020. The final 7-month follow-up is anticipated to be completed by fall/winter 2020. Because this is the first-ever evaluation of a quit vaping program, we were unable to draw on existing literature to determine the appropriate sample size. Therefore, we examined abstinence rates among an initial pilot sample of 269 participants (This is Quitting: n=148 and control: n=121) who completed the 1-month follow-up to determine the final sample size. The 1-month response rate was 79.2% (213/269), with no difference between arms. Using intention-to-treat analyses that counted nonresponders as still vaping, 30-day abstinence rates were 16.2% (24/148) among those randomized to This is Quitting and 8.3% (10/121) among those randomized to control. A treatment difference of 16% vs 8% is detectable with 80% power at 2-sided alpha=.05 with 260/group (520 total). To detect treatment differences of this magnitude in a 20% subsample (eg, Hispanic or sexual minority young adult e-cigarette users), we will enroll 1300/group (2600 total).
CONCLUSIONS
The scientific, clinical, and public health communities are desperate for cessation resources to address vaping among young people. This study is the first-ever comparative effectiveness trial of an intervention to help young people quit vaping. It focuses on evaluating the effectiveness of a theory-grounded, empirically informed text message intervention among young adults. The study is fully powered to examine potentially important subgroup differences among young people who are more vulnerable to e-cigarette use. Although potentially more challenging from a research ethics and pragmatic standpoint, evaluating quit vaping intervention approaches in teens is an important area for future research. Data from this trial will establish a benchmark of effectiveness for other vaping cessation programs and begin to create a body of evidence focused on how best to help young people break free from e-cigarettes.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04251273; https://clinicaltrials.gov/ct2/show/NCT04251273.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/18327.",2020,The study is fully powered to examine potentially important subgroup differences among young people who are more vulnerable to e-cigarette use.,"['young adults', '20% subsample (eg, Hispanic or sexual minority young adult e-cigarette users', 'young people quit vaping', 'young people who are more vulnerable to e-cigarette use', '269 participants (This is Quitting: n=148 and control: n=121) who completed the 1-month follow-up to determine the final sample size', '2600 young adult (aged 18-24 years) e-cigarette users in the United States will be recruited via web advertisements to participate in the study', 'Young Adult E-Cigarette Users']","['Quit Vaping Text Message Program', 'text message quit vaping program']","['30-day vaping abstinence at 7 months post enrollment', '30-day abstinence rates', '1-month response rate', 'abstinence rates']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C4083280', 'cui_str': 'Vape'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]",2600.0,0.115799,The study is fully powered to examine potentially important subgroup differences among young people who are more vulnerable to e-cigarette use.,"[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Graham', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Jacobs', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Amato', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Mia M', 'Initials': 'MM', 'LastName': 'Bottcher', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Papandonatos', 'Affiliation': 'Center for Statistical Sciences, Brown University, Providence, RI, United States.'}]",JMIR research protocols,['10.2196/18327']
71,32356926,Telmisartan as tentative angiotensin receptor blocker therapeutic for COVID-19.,"In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic. This new disease was named COVID-19 and the causative virus SARS-CoV-2. The SARS-CoV-2 virus enters the airway and binds, by means of the S protein on its surface to the membrane protein ACE2 in type 2 alveolar cells. The S protein-ACE2 complex is internalized by endocytosis leading to a partial decrease or total loss of the enzymatic function ACE2 in the alveolar cells and in turn increasing the tissue concentration of pro-inflammatory angiotensin II by decreasing its degradation and reducing the concentration of its physiological antagonist angiotensin 1-7. High levels of angiotensin II on the lung interstitium can promote apoptosis initiating an inflammatory process with release of proinflammatory cytokines, establishing a self-powered cascade, leading eventually to ARDS. Recently, Gurwitz proposed the tentative use of agents such as losartan and telmisartan as alternative options for treating COVID-19 patients prior to development of ARDS. In this commentary article, the authors make the case for the election of telmisartan as such alternative on the basis of its pharmacokinetic and pharmacodynamic properties and present an open-label randomized phase II clinical trial for the evaluation of telmisartan in COVID-19 patients (NCT04355936).",2020,"In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic.",[],"['Telmisartan', 'telmisartan', 'losartan and telmisartan']",[],[],"[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]",[],,0.0151336,"In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic.","[{'ForeName': 'Rodolfo Pedro', 'Initials': 'RP', 'LastName': 'Rothlin', 'Affiliation': 'Sociedad Argentina de Farmacología Clínica, Asociación Médica Argentina, Buenos Aires, Argentina.'}, {'ForeName': 'Héctor Miguel', 'Initials': 'HM', 'LastName': 'Vetulli', 'Affiliation': 'Servicio de Electrofisiología Cardíaca, Arritmias y Marcapasos, Sanatorio Otamendi y Miroli, Buenos Aires, Argentina.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Duarte', 'Affiliation': 'Hospital de Clínicas ""José de San Martín"", Facultad de Medicina, Universidad de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Facundo Germán', 'Initials': 'FG', 'LastName': 'Pelorosso', 'Affiliation': 'Department of Pathology, Hospital de Alta Complejidad El Calafate SAMIC, Santa Cruz, Argentina.'}]",Drug development research,['10.1002/ddr.21679']
72,31741066,Bone-filling mesh container versus percutaneous kyphoplasty in treating Kümmell's disease.,"Kümmell's disease (eponymous name for osteonecrosis and collapse of a vertebral body due to ischemia and non-union of anterior vertebral body wedge fractures after major trauma) cannot heal spontaneously. Bone-filling mesh container (BFMC) can significantly relieve pain, help the correction of kyphosis, and may prevent cement leakage. This pilot study may provide the basis for the design of future studies.
PURPOSE
To compare the effectiveness and safety of BFMC and percutaneous kyphoplasty (PKP) for treatment of Kümmell's disease.
METHODS
From August 2016 to May 2018, 40 patients with Kümmell's disease were admitted to Guizhou Provincial People's Hospital. Among them, 20 patients (20 vertebral bodies) received PKP (PKP group) and the other 20 received BFMC (BFMC group). Operation time, Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), Cobb's angle changes, and related complications were recorded.
RESULTS
All patients underwent operations successfully. VAS scores and ODI of both groups at each postoperative time point were lower than preoperatively, with statistically significant difference (p < 0.05). Postoperative Cobb's angle of both groups postoperatively was lower than preoperatively (p < 0.05). Cement leakage occurred in eight vertebrae (8/20) in the PKP group and in one vertebra (1/20) in the BFMC group. No complications such as pulmonary embolism, paraplegia, or perioperative death occurred during operation in both groups. Adjacent vertebral refractures occurred in five patients (5/20) in the PKP group and in four patients (4/20) in the BFMC group, with no significant difference in the incidence rate of refractures in both groups but the material is too small to verify statistically.
CONCLUSIONS
Both PKP and BFMC technologies can significantly relieve pain and help the correction of kyphosis while treating Kümmell's disease. Moreover, the BMFC may prevent cement leakage.",2019,"Adjacent vertebral refractures occurred in five patients (5/20) in the PKP group and in four patients (4/20) in the BFMC group, with no significant difference in the incidence rate of refractures in both groups but the material is too small to verify statistically.
","[""40 patients with Kümmell's disease were admitted to Guizhou Provincial People's Hospital"", ""Kümmell's disease"", 'From August 2016 to May 2018', '20 patients (20 vertebral bodies) received PKP (PKP group) and the other 20 received BFMC (BFMC group']","['BFMC and percutaneous kyphoplasty (PKP', 'BMFC', 'Bone-filling mesh container (BFMC', 'Bone-filling mesh container versus percutaneous kyphoplasty']","['cement leakage', 'Cement leakage', 'pain', 'Adjacent vertebral refractures', 'pulmonary embolism, paraplegia, or perioperative death', ""Operation time, Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), Cobb's angle changes, and related complications"", 'VAS scores and ODI', 'incidence rate of refractures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152088', 'cui_str': 'Traumatic spondylopathy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0180098', 'cui_str': 'Container'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0180098', 'cui_str': 'Container'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}, {'cui': 'C1301895', 'cui_str': 'Perioperative death'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",40.0,0.0272582,"Adjacent vertebral refractures occurred in five patients (5/20) in the PKP group and in four patients (4/20) in the BFMC group, with no significant difference in the incidence rate of refractures in both groups but the material is too small to verify statistically.
","[{'ForeName': 'Z-K', 'Initials': 'ZK', 'LastName': 'Duan', 'Affiliation': ""Department of Pain, Guizhou Provincial People's Hospital, Zhongshan Road, Guiyang, 550002, Guizhou, China.""}, {'ForeName': 'J-F', 'Initials': 'JF', 'LastName': 'Zou', 'Affiliation': ""Department of Pain, Guizhou Provincial People's Hospital, Zhongshan Road, Guiyang, 550002, Guizhou, China.""}, {'ForeName': 'X-L', 'Initials': 'XL', 'LastName': 'He', 'Affiliation': ""Department of Pain, Guizhou Provincial People's Hospital, Zhongshan Road, Guiyang, 550002, Guizhou, China.""}, {'ForeName': 'C-D', 'Initials': 'CD', 'LastName': 'Huang', 'Affiliation': ""Department of Pain, Guizhou Provincial People's Hospital, Zhongshan Road, Guiyang, 550002, Guizhou, China.""}, {'ForeName': 'C-J', 'Initials': 'CJ', 'LastName': 'He', 'Affiliation': ""Department of Pain, Guizhou Provincial People's Hospital, Zhongshan Road, Guiyang, 550002, Guizhou, China. hcj777330@163.com.""}]",Archives of osteoporosis,['10.1007/s11657-019-0656-4']
73,31768768,Effect of unfocused extracorporeal shockwave therapy on bone mineral content of twelve distal forearms of postmenopausal women: a clinical pilot study.,"Extracorporeal shockwave therapy showed a pronounced effect on bone mass in previous animal studies. We showed in this pilot study that a single treatment with unfocused shockwave therapy in unselected patients does not show side effects. Although our study did not show any effect of shockwave on BMD, the limited sample size does not definitively exclude this and a study with 174 subjects per group would be needed to show an effect size of 0.3 with a power of 80%.
PURPOSE
Unfocused extracorporeal shockwave therapy might stimulate bone formation to reduce the fracture risk. In this study, we assessed the safety of unfocused extracorporeal shockwave therapy and its effects on bone mass.
METHODS
A clinical pilot study with twelve female patients free of bone disease undergoing elective surgery of the lower extremity or elective spinal surgery under general anesthesia received 3.000 electrohydraulic-generated unfocused extracorporeal shockwaves (energy flux density 0.3 mJ/mm 2 ) to one distal forearm. The contralateral forearm served as a control. We examined the effect on bone mass with the use of repeated dual energy X-ray absorptiometry measurements and we measured patient discomfort around the therapy.
RESULTS
No difference in bone mineral content and density was measured 6 and 12 weeks after therapy. shockwave therapy occasionally caused transient erythema or mild hematoma, but no discomfort in daily life or (late) adverse events.
CONCLUSIONS
Unfocused extracorporeal shockwave therapy is a safe treatment, but no increase in bone mass on the forearm was found at 0.3 mJ/mm 2 energy flux density. In this study, we were not able to demonstrate that a single treatment with unfocused shockwave therapy in unselected patients had any effect in terms of bone mineral density (BMD) or bone mineral content (BMC). A power analysis indicated that 174 patients per group are required to show an effect size of 0.3 with a power of 80%.",2019,"Unfocused extracorporeal shockwave therapy is a safe treatment, but no increase in bone mass on the forearm was found at 0.3 mJ/mm 2 energy flux density.","['174 subjects per group', 'twelve female patients free of bone disease undergoing elective surgery of the lower extremity or elective spinal surgery under general anesthesia received 3.000', 'unselected patients', 'twelve distal forearms of postmenopausal women']","['Extracorporeal shockwave therapy', 'shockwave therapy', 'electrohydraulic-generated unfocused extracorporeal shockwaves ', 'extracorporeal shockwave therapy']","['transient erythema or mild hematoma', 'bone mineral content and density', 'bone mass', 'bone mineral density (BMD) or bone mineral content (BMC', 'bone mineral content', 'discomfort in daily life or (late) adverse events']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005940', 'cui_str': 'Disorder of bone'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442829', 'cui_str': 'Electrohydraulic'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",12.0,0.0450163,"Unfocused extracorporeal shockwave therapy is a safe treatment, but no increase in bone mass on the forearm was found at 0.3 mJ/mm 2 energy flux density.","[{'ForeName': 'Marianne K E', 'Initials': 'MKE', 'LastName': 'Koolen', 'Affiliation': 'Department of Orthopaedics, University Medical Centre Utrecht, Utrecht, The Netherlands. m.k.e.koolen@umcutrecht.nl.'}, {'ForeName': 'Moyo C', 'Initials': 'MC', 'LastName': 'Kruyt', 'Affiliation': 'Department of Orthopaedics, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Fetullah C', 'Initials': 'FC', 'LastName': 'Öner', 'Affiliation': 'Department of Orthopaedics, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schaden', 'Affiliation': 'Department of Traumatology, AUVA Trauma Center Meidling, Vienna, Austria.'}, {'ForeName': 'Harrie', 'Initials': 'H', 'LastName': 'Weinans', 'Affiliation': 'Department of Orthopaedics, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Olav P', 'Initials': 'OP', 'LastName': 'van der Jagt', 'Affiliation': 'Department of Orthopaedics, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}]",Archives of osteoporosis,['10.1007/s11657-019-0650-x']
74,32361126,Kinetic parameters during land and water walking performed by individuals with Down Syndrome.,"BACKGROUND
Down Syndrome (DS) is a genetic condition presenting delay in acquisition of main motor milestones, such as walking. Although studies have been investigating the biomechanical parameters during land walking performed by individual with DS, the literature is scarce regarding kinetic parameters analysis in this population, specially during water walking.
RESEARCH QUESTION
This study sought to assess the vertical ground reaction force (Fz) of walking performed in water and on land at different speeds by individuals with DS.
METHODS
Fourteen adults with DS (age: 27.9 ± 7.9 years; body mass: 58.4 ± 12.9 kg; height: 1.4 ± 0.1 m, body mass index: 29.2 ± 5.4 kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment. The protocol consisted of walking performed at three self-selected speeds (slow, comfortable and fast) in randomized order. The Fz was assessed with a waterproof force plate in each condition. Two-way repeated-measures ANOVA (environment and speed), with Bonferroni's post hoc tests, were used for analysis. A significance level was set as α = 0.05.
RESULTS
Significant differences were observed between environments (p < 0.001), with reduced first peak of Fz (68-73%), second peak of Fz (66-70%), loading rate (75-78%) and impulse (40-41%) in the water walking for all speeds analyzed. In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking. Moreover, the loading rate significantly increased (p = 0.019) as the impulse significantly reduced (p < 0.001) in the higher speeds.
SIGNIFICANCE
Individuals with DS present reduced Fz outcomes during water walking in comparison to land. Therefore, water walking may be performed by individuals with DS with safe vertical loads on lower limbs regardless the self-selected speed for rehabilitation, correction of gait and training purposes.",2020,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","['individuals with DS', 'individuals with Down Syndrome', 'Individuals with DS present', 'Fourteen adults with DS (age: 27.9\u2009±\u20097.9 years; body mass: 58.4\u2009±\u200912.9\u2009kg; height: 1.4\u2009±\u20090.1\u2009m, body mass index: 29.2\u2009±\u20095.4\u2009kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment']",['vertical ground reaction force (Fz) of walking performed in water and on land'],"['speed of walking', 'second peak of Fz', 'reduced Fz outcomes', 'loading rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0563034', 'cui_str': 'Aquatic environment'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0231467,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","[{'ForeName': 'Gabriela Neves', 'Initials': 'GN', 'LastName': 'Nunes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Stephanie Santana', 'Initials': 'SS', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Gabriele Randuz', 'Initials': 'GR', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Leonardo Alexandre', 'Initials': 'LA', 'LastName': 'Peyré-Tartaruga', 'Affiliation': 'Exercise Research Laboratory, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luana Siqueira', 'Initials': 'LS', 'LastName': 'Andrade', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Graciele Ferreira', 'Initials': 'GF', 'LastName': 'Mendes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Vitor de Lima', 'Initials': 'VL', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Rochele Barboza', 'Initials': 'RB', 'LastName': 'Pinheiro', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Alexandre Carriconde', 'Initials': 'AC', 'LastName': 'Marques', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Cristine Lima', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil. Electronic address: tinialberton@yahoo.com.br.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.017']
75,32298839,Progress of the ALIFE2 study: A dynamic road towards more evidence.,"Investigator-initiated studies are invaluable, especially in fields that are not particularly of interest for the pharmaceutical industry because they are either less profitable or concern special patient groups such as pregnant women. However, designing, conducting, and completing an investigator-initiated randomised controlled trial is challenging. Patients and physicians' preferences, ethics requirements, (international) legislation and funding are all areas where such challenges are encountered. The Anticoagulants for LIving FEtuses (ALIFE)2 study (NTR3361) is an example of an investigator initiated international multicenter trial that progresses slowly, at least initially, as many challenges had to be overcome. Here, we discuss the challenges we faced during the course of the ALIFE2 study up till now and we explain how some of these challenges can be tackled or even avoided.",2020,The Anticoagulants for LIving FEtuses,"['pregnant women', 'LIving FEtuses']",[],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}]",[],[],,0.0353679,The Anticoagulants for LIving FEtuses,"[{'ForeName': 'Eva N', 'Initials': 'EN', 'LastName': 'Hamulyák', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: e.n.hamulyak@amsterdamumc.nl.'}, {'ForeName': 'Paulien G', 'Initials': 'PG', 'LastName': 'de Jong', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Luuk J J', 'Initials': 'LJJ', 'LastName': 'Scheres', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Ewington', 'Affiliation': 'Warwick Medical School, University Hospitals Coventry and Warwickshire NHS trust, Coventry, United Kingdom.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Middeldorp', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Quenby', 'Affiliation': 'Warwick Medical School, University Hospitals Coventry and Warwickshire NHS trust, Coventry, United Kingdom.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",Thrombosis research,['10.1016/j.thromres.2020.03.015']
76,32299310,Introduction to the special edition on the placebo effect in sport and exercise.,,2020,,[],[],[],[],[],[],,0.0453474,,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Beedie', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, UK.'}, {'ForeName': 'Florentina', 'Initials': 'F', 'LastName': 'Hettinga', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle-Upon-Tyne, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1757682']
77,32365355,L-Thyroxine Therapy for Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms: Secondary Analysis of a Randomized Trial.,"BACKGROUND
L-thyroxine does not improve hypothyroid symptoms among adults with subclinical hypothyroidism (SCH). However, those with greater symptom burden before treatment may still benefit.
OBJECTIVE
To determine whether L-thyroxine improves hypothyroid symptoms and tiredness among older adults with SCH and greater symptom burden.
DESIGN
Secondary analysis of the randomized, placebo-controlled trial TRUST (Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism Trial). (ClinicalTrials.gov: NCT01660126).
SETTING
Switzerland, Ireland, the Netherlands, and Scotland.
PARTICIPANTS
638 persons aged 65 years or older with persistent SCH (thyroid-stimulating hormone level of 4.60 to 19.9 mIU/L for >3 months and normal free thyroxine level) and complete outcome data.
INTERVENTION
L-thyroxine or matching placebo with mock dose titration.
MEASUREMENTS
1-year change in Hypothyroid Symptoms and Tiredness scores (range, 0 to 100; higher scores indicate more symptoms) on the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire among participants with high symptom burden (baseline Hypothyroid Symptoms score >30 or Tiredness score >40) versus lower symptom burden.
RESULTS
132 participants had Hypothyroid Symptoms scores greater than 30, and 133 had Tiredness scores greater than 40. Among the group with high symptom burden, the Hypothyroid Symptoms score improved similarly between those receiving L-thyroxine (mean within-group change, -12.3 [95% CI, -16.6 to -8.0]) and those receiving placebo (mean within-group change, -10.4 [CI, -15.3 to -5.4]) at 1 year; the adjusted between-group difference was -2.0 (CI, -5.5 to 1.5; P = 0.27). Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; P = 0.99). There was no evidence that baseline Hypothyroid Symptoms score or Tiredness score modified the effects of L-thyroxine versus placebo ( P for interaction = 0.20 and 0.82, respectively).
LIMITATION
Post hoc analysis, small sample size, and examination of only patients with 1-year outcome data.
CONCLUSION
In older adults with SCH and high symptom burden at baseline, L-thyroxine did not improve hypothyroid symptoms or tiredness compared with placebo.
PRIMARY FUNDING SOURCE
European Union FP7.",2020,"Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; P = 0.99).","['Untreated Older Adults with Subclinical Hypothyroidism Trial', '132 participants had', 'adults with subclinical hypothyroidism (SCH', 'Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms', 'Participants\n\n\n638 persons aged 65 years or older with persistent SCH (thyroid-stimulating hormone level of 4.60 to 19.9 mIU/L for >3 months and normal free thyroxine level) and complete outcome data', 'older adults with SCH and greater symptom burden']","['Intervention\n\n\nL-thyroxine or matching placebo', 'L-thyroxine', 'placebo-controlled trial TRUST (Thyroid Hormone Replacement', 'L-Thyroxine Therapy', '\n\n\nL-thyroxine', 'placebo']","['Hypothyroid Symptoms score', 'hypothyroid symptoms and tiredness', 'Hypothyroid Symptoms scores', 'Hypothyroid Symptoms and Tiredness scores', 'hypothyroid symptoms or tiredness', 'baseline Hypothyroid Symptoms score or Tiredness score', 'Tiredness scores', 'hypothyroid symptoms']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0439462', 'cui_str': 'mIU/L'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0861033', 'cui_str': 'Thyroxine free normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",638.0,0.652293,"Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; P = 0.99).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Montmollin', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Beglinger', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland (A.M., I.F.).'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.A.).'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, and University of Lausanne, Lausanne, Switzerland (T.C.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland (A.M., I.F.).'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands (J.G., R.K.P.).'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland (P.M.K.).'}, {'ForeName': 'Vera J C', 'Initials': 'VJC', 'LastName': 'McCarthy', 'Affiliation': 'School of Nursing and Midwifery, University College Cork, Cork, Ireland (V.J.M.).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mooijaart', 'Affiliation': 'Institute for Evidence-based Medicine in Old Age, Leiden University Medical Center, Leiden, the Netherlands (S.M.).'}, {'ForeName': 'Rosalinde K E', 'Initials': 'RKE', 'LastName': 'Poortvliet', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands (J.G., R.K.P.).'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland (T.Q., D.J.S.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland (T.Q., D.J.S.).'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Copenhagen University Hospital Herlev, Herlev, Denmark, and University of Copenhagen, Copenhagen, Denmark (T.W., R.W.).'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Westendorp', 'Affiliation': 'Copenhagen University Hospital Herlev, Herlev, Denmark, and University of Copenhagen, Copenhagen, Denmark (T.W., R.W.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark; and University of California, San Francisco, San Francisco, California (D.C.B.).'}]",Annals of internal medicine,['10.7326/M19-3193']
78,32385848,"Health Literacy and Parental Oral Health Knowledge, Beliefs, Behavior, and Status Among Parents of American Indian Newborns.","OBJECTIVE
To examine the relationship between health literacy (HL) and parental oral health knowledge, beliefs, behavior, and self-reported oral health status (OHS) among parents of American Indian (AI) children.
METHODS
This analysis used baseline data from a randomized controlled trial that tested an oral health intervention with parents of AI newborns. Participants were recruited in parent-child dyads (N = 579). Parents completed items assessing sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, behavior, and self-reported OHS. We examined the correlation of HL with each oral health construct, controlling for parent age and income.
RESULTS
On average, parents felt quite confident in their HL skills, performed well on questions assessing parental oral health knowledge, and endorsed beliefs likely to encourage positive parental oral health behaviors (e.g., confidence that one can successfully engage in such behaviors). Parents with more limited HL had significantly less knowledge, perceived cavities to be less severe, perceived more barriers and fewer benefits to recommended oral health behaviors, were less confident they could engage in these behaviors, and were more likely to believe their children's oral health was under the control of the dentist or a matter of chance (P values < 0.001). Limited HL was not associated with behavior (P > 0.05) but was linked to worse self-reported OHS (P = 0.040).
CONCLUSIONS
HL was associated with parental oral health knowledge, beliefs, and self-reported OHS. Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.",2020,Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.,"['Participants were recruited in parent-child dyads (N\u2009=\u2009579', 'parents with more limited HL skills', 'with parents of AI newborns', 'Parents of American Indian Newborns', 'parents of American Indian (AI) children']",['oral health intervention'],"['sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, behavior, and self-reported OHS', 'health literacy (HL) and parental oral health knowledge, beliefs, behavior, and self-reported oral health status (OHS', 'Health Literacy and Parental Oral Health Knowledge, Beliefs, Behavior, and Status']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0459279,Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.,"[{'ForeName': 'Angela G', 'Initials': 'AG', 'LastName': 'Brega', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13055 East 17th Avenue, Aurora, CO, 80045, USA. angela.brega@cuanschutz.edu.'}, {'ForeName': 'Luohua', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Medicine, University of California Irvine, 205B Irvine Hall, Irvine, CA, 92697, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 East 17th Place, Aurora, CO, 80045, USA.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Wilson', 'Affiliation': 'Department of Pediatric Dentistry, School of Dental Medicine, University of Colorado Anschutz Medical Campus, 13123 East 16th Avenue, Aurora, CO, 80045, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 East 17th Place, Aurora, CO, 80045, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Albino', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13055 East 17th Avenue, Aurora, CO, 80045, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00688-4']
79,32386308,Preoperative Topical Estrogen Treatment vs Placebo in 244 Children With Midshaft and Posterior Hypospadias.,"PURPOSE
Urethral fistula and dehiscence are common after hypospadias surgery. Preoperative androgens have been considered to reduce these complications although this consideration is not evidence-based. Dermatologists have reported the benefits of topical estrogens on skin healing. We investigated whether the preoperative use of topical promestriene could reduce healing complications in hypospadias surgery. Our primary objective was to demonstrate a reduction of healing complications with promestriene vs placebo. Impact on reoperations and other complications, clinical tolerance, bone growth, and biological systemic effects of the treatment were also considered.
METHODS
We conducted a prospective, randomized, placebo-controlled, double-blind, parallel group trial between 2011 and 2015 in 4 French centers. One-stage transverse preputial island flap urethroplasty (onlay urethroplasty) was selected for severe hypospadias. Promestriene or placebo was applied on the penis for 2 months prior to surgery. The primary outcome was the presence of postoperative urethral fistula or dehiscence in the first year postsurgery. For safety reasons, hormonal and anatomical screenings were performed.
RESULTS
Out of 241 patients who received surgery, 122 patients were randomized to receive placebo, and 119 patients received promestriene. The primary outcome was unavailable for 11 patients. Healing complications were assessed at 16.4% (19/116) in the placebo vs 14.9% (17/114) in the promestriene arm, and the odds ratio adjusted on center was 0.93 (95% confidence interval 0.45-1.94), P = 0.86.
CONCLUSIONS AND RELEVANCE
Although we observed an overall lower risk of complications compared to previous publications, postsurgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of promestriene.",2020,"Although we observed an overall lower risk of complications compared to previous publications, post-surgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of Promestriene.","['hypospadias surgery', '241 patients who received surgery', '2011 and 2015, in 4 French centers', '122 patients', '244 children with midshaft and posterior hypospadias']","['topical Estrogens', 'topical Promestriene', 'Promestriene or placebo', 'placebo']","['healing complications', 'reoperations and other complications, clinical tolerance, bone growth and biological systemic effects', 'presence of postoperative urethral fistula or dehiscence in the first year post-surgery', 'skin healing', 'Healing complications']","[{'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0072151', 'cui_str': 'promestriene'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0971859', 'cui_str': 'Bone Growth'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0041970', 'cui_str': 'Urethral fistula'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",241.0,0.658829,"Although we observed an overall lower risk of complications compared to previous publications, post-surgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of Promestriene.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Gorduza', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Plotton', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Remontet', 'Affiliation': 'Université de Lyon, Lyon, France.'}, {'ForeName': 'Claire-Lise', 'Initials': 'CL', 'LastName': 'Gay', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'El Jani', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Cheikhelard', 'Affiliation': 'Service de chirurgie viscérale et urologie pédiatrique, APHP, Hôpital Necker, Paris, France; Université Sorbonne Paris cité, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Blanc', 'Affiliation': 'Service de chirurgie viscérale et urologie pédiatrique, APHP, Hôpital Necker, Paris, France; Université Sorbonne Paris cité, Paris, France.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'El Ghoneimi', 'Affiliation': 'Service de chirurgie viscérale et urologie pédiatrique, Centre de Référence des Maladies Endocriniennes Rares de la Croissance, Hôpital Robert Debré, APHP, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Marc-David', 'Initials': 'MD', 'LastName': 'Leclair', 'Affiliation': 'Service de chirurgie pédiatrique, CHU de Nantes, Nantes, Loire Atlantique, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Roy', 'Affiliation': 'Université de Lyon, Lyon, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Pirot', 'Affiliation': 'Service pharmaceutique, Plateforme FRIPHARM, Groupement Hospitalier Edouard Herriot, Lyon Cedex, France.'}, {'ForeName': 'Yanis', 'Initials': 'Y', 'LastName': 'Mimouni', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France.'}, {'ForeName': 'Segolene', 'Initials': 'S', 'LastName': 'Gaillard', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chatelain', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Morel', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Kassai', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Mouriquand', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa231']
80,32386466,Group-based multimodal physical therapy in women with chronic pelvic pain: A randomized controlled trial.,"INTRODUCTION
Chronic pelvic pain in women is a complex condition, and physical therapy is recommended as part of a broader treatment approach. The objective of this study was to compare structured group-based multimodal physical therapy in a hospital setting (intervention group) with primary-care physical therapy (comparator group) for women with chronic pelvic pain.
MATERIAL AND METHODS
Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible. The primary outcome measure was change in the mean pelvic pain intensity from baseline to 12 months, measured using the numeric rating scale (0-10). Secondary outcomes were changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation. The differences between the groups regarding change in scores were analyzed using the independent t test and Mann-Whitney U test. Sensitivity analysis of the primary outcome was performed with a linear regression model adjusted for the baseline value. A P value <.05 was considered statistically significant.
RESULTS
Of the 62 women included, 26 in the intervention group and 25 in the comparator group were available after 12 months for data collection and analysis. The difference between the groups for change in the mean pain intensity score was -1.2 (95% CI -2.3 to -0.2; P = .027), favoring the intervention group. The intervention group showed greater improvements in respiratory patterns (mean difference 0.9; 95% CI 0.2-1.6; P = .015) and pain-related fear of movements (mean difference 2.9; 95% CI -5.5 to -0.3; P = .032), and no significant differences were observed between the groups for the other secondary outcomes.
CONCLUSIONS
Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary-care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.",2020,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","['women with chronic pelvic pain', 'Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible']","['multimodal physical therapy', 'primary care physical therapy (comparator group', 'structured group-based multimodal physical therapy']","['mean pain intensity score', 'respiratory patterns', 'pain-related fear of movements', 'numeric rating scale', 'changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation', 'mean pelvic pain intensity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517967', 'cui_str': 'Respiratory pattern'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.107811,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","[{'ForeName': 'Ane Sigrid', 'Initials': 'AS', 'LastName': 'Nygaard', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona Birgitte', 'Initials': 'MB', 'LastName': 'Rydningen', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stedenfeldt', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Wojniusz', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Marthe', 'Initials': 'M', 'LastName': 'Larsen', 'Affiliation': 'Clinical Research Department, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Rolv-Ole', 'Initials': 'RO', 'LastName': 'Lindsetmo', 'Affiliation': 'Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Gro Killi', 'Initials': 'GK', 'LastName': 'Haugstad', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Tromsø, Norway.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13896']
81,32390591,A Smartphone App-Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial.,"BACKGROUND
Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app-based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience.
OBJECTIVE
The SEAMLESS (Smartphone App-Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship-MBCS-Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors.
METHODS
This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users' engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology.
RESULTS
The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques.
CONCLUSIONS
Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today's digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/15178.",2020,"The SEAMLESS (Smartphone App-Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship-MBCS-Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes).","['Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors', 'cancer survivors', 'Cancer Survivors', 'cancer survivors who have completed all their cancer treatments']","['tailored mindfulness app intervention', 'app-based mindfulness intervention', 'Smartphone App-Based Mindfulness Intervention', 'Smartphone app-based MBIs', 'tailored app-based mindfulness intervention', 'SEAMLESS (Smartphone App-Based Mindfulness Intervention', 'Am MBCS', 'Mindfulness-based interventions (MBIs']","['well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C4275029', 'cui_str': 'Maternal uniparental disomy of chromosome 20'}]","[{'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.129973,"The SEAMLESS (Smartphone App-Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship-MBCS-Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes).","[{'ForeName': 'Utkarsh B', 'Initials': 'UB', 'LastName': 'Subnis', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Norman As', 'Initials': 'NA', 'LastName': 'Farb', 'Affiliation': 'Department of Psychology, University of Toronto Mississauga, Mississauga, ON, Canada.'}, {'ForeName': 'Katherine-Ann Laura', 'Initials': 'KL', 'LastName': 'Piedalue', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Speca', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Lupichuk', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Tang', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Faris', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Thoburn', 'Affiliation': 'Mobio Interactive, Toronto, ON, Canada.'}, {'ForeName': 'Bechara J', 'Initials': 'BJ', 'LastName': 'Saab', 'Affiliation': 'Mobio Interactive, Toronto, ON, Canada.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}]",JMIR research protocols,['10.2196/15178']
82,32353635,Feasibility of decision rule-based treatment of comorbid youth: A pilot randomized control trial.,"This study examined the feasibility, acceptability, and preliminary efficacy of a decision rule driven treatment for youth with comorbid conduct problems and depression. A randomized, controlled, repeated measures design was used to compare two treatment approaches: Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ). Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder). Assessments were conducted at baseline, post-treatment, and six-month follow-up. Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions. Both treatments showed similar remission of internalizing and externalizing diagnoses. Participants in DR showed significantly greater improvements at six-month follow-up in child-reported depressive symptom severity compared to SEQ. Both DR and SEQ conditions showed significantly lower behavior problems at end of treatment and six-month follow-up. DR showed significant reductions in emotion dysregulation at 6-month follow-up, while SEQ did not. Findings suggest that a decision rule based intervention holds promise as a feasible and acceptable treatment with high rates of remittance.",2020,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","['Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder', 'youth with comorbid conduct problems and depression', 'comorbid youth']",['Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ'],"['remission of internalizing and externalizing diagnoses', 'behavior problems', 'depressive symptom severity', 'emotion dysregulation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0310239,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Wolff', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA. Electronic address: jennifer_wolff@brown.edu.'}, {'ForeName': 'Abbe', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Kelly', 'Affiliation': 'Rhode Island Hospital, Providence, RI, USA; University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Frazier', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103625']
83,32356581,Diabetic retinopathy progression 6 months post-cataract surgery with intravitreous bevacizumab vs triamcinolone: A secondary analysis of the DiMECAT trial.,"IMPORTANCE
Diabetic retinopathy (DR) may progress following cataract surgery due to surgery-induced inflammation. The effect of intravitreal bevacizumab (BVB) and triamcinolone acetonide (TCA), which have differing anti-inflammatory properties, on DR progression following cataract surgery has not been reported.
BACKGROUND
To report the progression of DR in diabetic patients undergoing cataract extraction treated with intravitreal BVB or TCA during the surgery.
DESIGN
Post hoc analysis of 6-month data from a prospective, randomized, double-masked clinical trial.
PARTICIPANTS
Diabetic patients with clinically significant cataract and fovea involving diabetic macular oedema (DME), or a recent history of DME.
METHODS
Participants were randomly allocated 1:1 to receive intravitreal BVB 1.25 mg or TCA 4 mg during and post-cataract surgery as needed. The rate of DR progression between groups was compared.
MAIN OUTCOME MEASURES
DR progression.
RESULTS
There were 61 eyes included. Patients receiving BVB were older than those receiving TCA (70.2 vs 64.3 years; P < .05). Three participants (10.7%) in the BVB and three (9.09%) in the TCA group had a one-step progression, while none in BVB and only one (3%) in the TCA group demonstrated two-step DR progression. In the majority of these patients, DR progression was from mild to moderate non-proliferative diabetic retinopathy.
CONCLUSION AND RELEVANCE
In this study, BVB and TCA groups had a similar, and lower rate of DR progression compared to previous studies where no adjunctive treatment was administered, suggesting that patients with DME may benefit from either intraoperative intravitreous BVB or TCA injection to reduce the risk of DR progression following cataract surgery.",2020,Patients receiving BVB were older than those receiving TCA (70.2 vs 64.3 years; P < 0.05).,"['Participants', ' Diabetic patients with clinically significant cataract and fovea involving diabetic macular oedema (DME), or a recent history of DME', 'diabetic patients undergoing cataract extraction treated with', 'Diabetic retinopathy (DR']","['intravitreal bevacizumab (BVB', 'TCA injection', 'TCA', 'intravitreal BVB or TCA', 'intravitreous bevacizumab vs triamc1inolone', 'intravitreal BVB 1.25 mg or TCA', 'triamcinolone acetonide (TCA']","['Diabetic retinopathy progression', '2-step DR progression', 'risk of DR progression', 'rate of DR progression', 'DR progression']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517497', 'cui_str': '1.25'}]","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",61.0,0.0698005,Patients receiving BVB were older than those receiving TCA (70.2 vs 64.3 years; P < 0.05).,"[{'ForeName': 'Muhammad B', 'Initials': 'MB', 'LastName': 'Sasongko', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rogers', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sukhpal S', 'Initials': 'SS', 'LastName': 'Sandhu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sanjeewa S', 'Initials': 'SS', 'LastName': 'Wickremasinghe', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Salmaan', 'Initials': 'S', 'LastName': 'Al-Qureshi', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13771']
84,32300790,"Response to Letter to the Editor: ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],[],[],[],[],[],,0.0185509,,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa209']
85,32368935,A Randomized Controlled Trial of Bone-Patellar Tendon-Bone Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis: 19-Year Clinical and Radiological Follow-up.,"BACKGROUND
Arthroscopic anterior cruciate ligament (ACL) reconstruction (ACLR) with a bone-patellar tendon-bone graft (BTB) is a reliable surgical option for the control of anterior knee laxity after ACL injury. The addition of a lateral extra-articular tenodesis (LET) may improve control of rotation knee laxity and improve short-term graft survival in high-risk patients.
PURPOSE
The aims of this study were to compare long-term patient-reported outcomes, graft survival, and risk of osteoarthritis between ACLR with and without LET.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 2.
METHODS
This study included 121 consecutive knees (120 patients) presenting to a single center with an ACL rupture between 1998 and 1999. In total, 61 knees were randomized to an isolated BTB ACLR, and 60 knees were randomized to a BTB ACLR with an extra-articular lateral tenodesis with gracilis tendon (modified Lemaire).
RESULTS
Eighty knees in 79 patients (66%) were available for follow-up at a postoperative mean of 19.4 years (range, 19-20.2). Of those patients, 43 had a clinical examination and completed patient-reported outcome questionnaires, and the other 37 patients were evaluated through the questionnaires alone. Standard radiographs were available for 45 patients and laximetry (TELOS) for 42 patients. Mean subjective International Knee Documentation Committee score at last follow-up was 81.8, and no differences were noted between the BTB and BTB-LET groups ( P = .7). Two-thirds of patients were still participating in pivoting sports. A total of 17 knees (21%) experienced a graft failure, 5 of which (6%) underwent revision ACLR. There was no significant difference in graft failure risk between the BTB group (29%) and the BTB-LET group (13%; P = .1). Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%; P = .02). Lateral compartment osteoarthritis was correlated with partial lateral meniscectomy.
CONCLUSION
There were no significant differences in long-term patient-reported outcomes after ACLR with or without an LET. LET may increase the risk of lateral compartment osteoarthritis at long-term follow-up. There was a trend toward decreased graft failure risk with the addition of LET but this study was underpowered to assess this outcome.",2020,Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%; P = .02).,"['61 knees were randomized to an isolated BTB ACLR, and 60 knees', 'high-risk patients', '45 patients and laximetry (TELOS) for 42 patients', '121 consecutive knees (120 patients) presenting to a single center with an ACL rupture between 1998 and 1999', 'Eighty knees in 79 patients (66%) were available for follow-up at a postoperative mean of 19.4 years (range, 19-20.2']","['Bone-Patellar Tendon-Bone Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis', 'LET', 'BTB ACLR with an extra-articular lateral tenodesis with gracilis tendon (modified Lemaire', 'Arthroscopic anterior cruciate ligament (ACL) reconstruction (ACLR) with a bone-patellar tendon-bone graft (BTB', 'lateral extra-articular tenodesis (LET']","['graft failure risk', 'Mean subjective International Knee Documentation Committee score', 'Lateral compartment osteoarthritis', 'graft survival, and risk of osteoarthritis', 'risk of lateral compartment osteoarthritis', 'Lateral tibiofemoral osteoarthritis', 'rotation knee laxity and improve short-term graft survival', 'graft failure']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C3658331', 'cui_str': 'Bone-Patellar Tendon-Bone Grafts'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517642', 'cui_str': '20.2'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0185441', 'cui_str': 'Fixation of tendon'}, {'cui': 'C3658331', 'cui_str': 'Bone-Patellar Tendon-Bone Grafts'}, {'cui': 'C0448621', 'cui_str': 'Tendon of gracilis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",61.0,0.143888,Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%; P = .02).,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Castoldi', 'Affiliation': 'Institut Universitaire Locomoteur et du Sport, Department of Orthopaedic Surgery, Centre Hospitalo-Universitaire de Nice, Nice, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Magnussen', 'Affiliation': 'Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Gunst', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Batailler', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Neyret', 'Affiliation': 'Infirmerie Protestante, Caluire, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Lustig', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}, {'ForeName': 'Elvire', 'Initials': 'E', 'LastName': 'Servien', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}]",The American journal of sports medicine,['10.1177/0363546520914936']
86,32361367,Feasibility of a text-based reduction intervention in helping rural and underserved smokeless tobacco users quit.,"INTRODUCTION
Smokeless tobacco (ST) use significantly affects morbidity and mortality and remains disproportionally prevalent in rural and medically underserved communities. Few programs exist for rural smokeless tobacco users. Text-based interventions may increase the reach of cessation interventions; yet, none has tested them in ST users. We evaluated the feasibility, acceptability, and preliminary efficacy of a text-based Scheduled Gradual Reduction (SGR) intervention in rural and underserved ST users.
METHODS
ST users were randomized in 2:1 fashion to the SGR group (N = 65), a text-based reduction program plus text-based support counseling messages or text-based support messages only group (N = 33). We surveyed participants at 30-days post intervention initiation to assess feasibility and acceptability and examined self-report 7-day point prevalence cessation at 30-days and 6-months post intervention initiation in the two arms.
RESULTS
We achieved benchmarks for feasibility and acceptability. Among the SGR participants 51% (n = 48) reported that intervention was useful in helping them quit, 83% (n = 48) indicated that they would recommend the intervention to a friend. Over 95% (n = 39) of SGR participants said that they read all alert texts. The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect). However, the quit rate at 6-months was 21% (p = 0.9703) for both groups.
CONCLUSIONS
A text-based intervention was feasible and acceptable among underserved ST users. SGR helped promote short-term cessation. The text-based interventions both had long-term efficacy. Given that text-based interventions have the potential to increase reach in underserved ST users, further testing is warranted.",2020,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","['helping rural and underserved smokeless tobacco users quit', 'rural and underserved ST users', 'rural and medically underserved communities', 'rural smokeless tobacco users', 'ST users']","['text-based Scheduled Gradual Reduction (SGR) intervention', 'text-based reduction intervention', 'Smokeless tobacco (ST', 'text-based reduction program plus text-based support counseling messages or text-based support messages only group', 'SGR']","['feasibility and acceptability and examined self-report 7-day point prevalence cessation', 'feasibility and acceptability', 'quit rate']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",51.0,0.0567251,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","[{'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States. Electronic address: devon.noonan@duke.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Community and Family Medicine, 2424 Erwin Rd, Suite 602, Durham, NC 27710, United States.'}, {'ForeName': 'Kellen', 'Initials': 'K', 'LastName': 'Peter', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Conley', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Simmons', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; University of California, Davis, Department of Human Ecology, 301 Shields Avenue, Davis, CA 95616, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Dr, Eugene, OR 97403, United States.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Pupulation Health Sciences, 2424 Erwin Road Suite 602, Durham, NC 27710, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106434']
87,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
88,31190621,Effects of SLCO1B1 polymorphisms on plasma estrogen concentrations in women with breast cancer receiving aromatase inhibitors exemestane and letrozole.,"Aim: This study tested for associations between SLCO1B1 polymorphisms and circulating estrogen levels in women with breast cancer treated with letrozole or exemestane. Patients & methods: Postmenopausal women with hormone-receptor positive breast cancer were genotyped for SLCO1B1*5 (rs4149056) and rs10841753. Pretreatment and on-treatment plasma estrogens and aromatase inhibitor (AI) concentrations were measured. Regression analyses were performed to test for pharmacogenetic associations with estrogens and drug concentrations. Results: SLCO1B1*5 was associated with elevated pretreatment estrone sulfate and an increased risk of detectable estrone concentrations after 3 months of AI treatment. Conclusion: These findings suggest SLCO1B1 polymorphisms may have an effect on estrogenic response to AI treatment, and therefore may adversely impact the anticancer effectiveness of these agents.",2019,Results: SLCO1B1*5 was associated with elevated pretreatment estrone sulfate and an increased risk of detectable estrone concentrations after 3 months of AI treatment. ,"['women with breast cancer receiving aromatase inhibitors exemestane and', 'Postmenopausal women with hormone-receptor positive breast cancer', 'women with breast cancer treated with']","['letrozole', 'letrozole or exemestane', 'SLCO1B1 polymorphisms']","['treatment plasma estrogens and aromatase inhibitor (AI) concentrations', 'risk of detectable estrone concentrations', 'plasma estrogen concentrations', 'estrogenic response', 'elevated pretreatment estrone sulfate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0857702', 'cui_str': 'Plasma oestrogen'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0059668', 'cui_str': 'Estrone sulfate'}]",,0.0545496,Results: SLCO1B1*5 was associated with elevated pretreatment estrone sulfate and an increased risk of detectable estrone concentrations after 3 months of AI treatment. ,"[{'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Dempsey', 'Affiliation': 'Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI 48109-1065, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Gersch', 'Affiliation': 'Department of Internal Medicine, Division of Hematology/Oncology, Medical School, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Pesch', 'Affiliation': 'Department of Internal Medicine, Division of Hematology/Oncology, Medical School, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Zeruesenay', 'Initials': 'Z', 'LastName': 'Desta', 'Affiliation': 'Department of Medicine, Indiana University, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Storniolo', 'Affiliation': 'Department of Medicine, Indiana University, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Stearns', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD 21231, USA.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Skaar', 'Affiliation': 'Department of Medicine, Indiana University, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'Department of Internal Medicine, Division of Hematology/Oncology, Medical School, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'Department of Internal Medicine, Division of Hematology/Oncology, Medical School, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Rae', 'Affiliation': 'Department of Internal Medicine, Division of Hematology/Oncology, Medical School, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hertz', 'Affiliation': 'Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI 48109-1065, USA.'}]",Pharmacogenomics,['10.2217/pgs-2019-0020']
89,32361934,"Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase II, Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial.","OBJECTIVE
To assess the effect and safety of Hydroxysafflor Yellow A for Injection (HSYAI) in treating patients with acute ischemic stroke (AIS) and blood stasis syndrome (BSS).
METHODS
A multicenter, randomized, double-blind, multiple-dose, active-controlled phase II trial was conducted at 9 centers in China from July 2013 to September 2015. Patients with moderate or severe AIS and BSS were randomly assigned to low-, medium-, high-dose HSYAI groups (25, 50 and 70 mg/d HSYAI by intravenous infusion, respectively), and a control group (Dengzhan Xixin Injection (, DZXXI) 30 mL/d by intravenous infusion), for 14 consecutive days. The primary outcome was the Modified Rankin Scale (mRS) score ⩽1 at days 90 after treatment. The secondary outcomes included the National Institute of Health Stroke Scale (NIHSS) score ⩽1, Barthel Index (BI) score ⩾95, and BSS score reduced ⩾30% from baseline at days 14, 30, 60, and 90 after treatment. The safety outcomes included any adverse events during 90 days after treatment.
RESULTS
Of the 266 patients included in the effectiveness analysis, 66, 67, 65 and 68 cases were in the low-, medium-, and high-dose HSYAI and control groups, respectively. The proportions of patients in the medium- and high-dose HSYAI groups with mRS score ⩽1 at days 90 after treatment were significantly larger than the control group (P<0.05). The incidences of favorable outcomes of NIHSS and BI at days 90 after treatment as well as satisfactory improvement of BSS at days 30 and 60 after treatment in the medium- and high-dose HSYAI groups were all significantly higher than the control group (P<0.05). No significant difference was reported among the 4 groups in any specific adverse events (P>0.05).
CONCLUSIONS
HSYAI was safe and well-tolerated at all doses for treating AIS patients with BSS. The medium (50 mg/d) or high dose (75 mg/d) might be the optimal dose for a phase III trial. (Registration No. ChiCTR-2000029608).",2020,"No significant difference was reported among the 4 groups in any specific adverse events (P>0.05).
","['Patients with Acute Ischemic Stroke of Blood Stasis Syndrome', '9 centers in China from July 2013 to September 2015', '266 patients included in the effectiveness analysis, 66, 67, 65 and 68 cases', 'Patients with moderate or severe AIS and BSS', 'patients with acute ischemic stroke (AIS) and blood stasis syndrome (BSS']","['Hydroxysafflor Yellow A for Injection (HSYAI', 'control group (Dengzhan Xixin Injection (, DZXXI', 'Hydroxysafflor Yellow A']","['National Institute of Health Stroke Scale (NIHSS) score ⩽1, Barthel Index (BI) score ⩾95, and BSS score', 'satisfactory improvement of BSS', 'NIHSS and BI', 'safe and well-tolerated', 'adverse events', 'Modified Rankin Scale (mRS) score ⩽1', 'specific adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005750', 'cui_str': 'Blind loop syndrome'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0250747', 'cui_str': 'hydroxysafflor yellow A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005750', 'cui_str': 'Blind loop syndrome'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.224667,"No significant difference was reported among the 4 groups in any specific adverse events (P>0.05).
","[{'ForeName': 'Ming-Zhe', 'Initials': 'MZ', 'LastName': 'Hu', 'Affiliation': 'The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510006, China.'}, {'ForeName': 'Zi-Yi', 'Initials': 'ZY', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Zhong-Yu', 'Initials': 'ZY', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, 430061, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning, 530011, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, 510095, China.'}, {'ForeName': 'Long-Min', 'Initials': 'LM', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200062, China.'}, {'ForeName': 'Hai-Qing', 'Initials': 'HQ', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'An-Ji', 'Initials': 'AJ', 'LastName': 'Lin', 'Affiliation': 'Department of Traditional Chinese Medicine, Xiamen Hospital of Traditional Chinese Medicine, Xiamen, 361001, China.'}, {'ForeName': 'Qing-Ming', 'Initials': 'QM', 'LastName': 'Wu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, 410005, China.'}, {'ForeName': 'Hong-Fei', 'Initials': 'HF', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, 110032, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Youcare Pharmaceutical Group Dingcheng Branch, Beijing, 100176, China.'}, {'ForeName': 'Ye-Feng', 'Initials': 'YF', 'LastName': 'Cai', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China. caiyefeng@126.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3094-7']
90,32363656,Lower cognitive baseline scores predict cognitive training success after 6 months in healthy older adults: Results of an online RCT.,"BACKGROUND
Identifying predictors for general cognitive training (GCT) success in healthy older adults has many potential uses, including aiding intervention and improving individual dementia risk prediction, which are of high importance in health care. However, the factors that predict training improvements and the temporal course of predictors (eg, do the same prognostic factors predict training success after a short training period, such as 6 weeks, as well as after a longer training period, such as 6 months?) are largely unknown.
METHODS
Data (N = 4,184 healthy older individuals) from two arms (GCT vs. control) of a three-arm randomized controlled trial were reanalyzed to investigate predictors of GCT success in five cognitive tasks (grammatical reasoning, spatial working memory, digit vigilance, paired association learning, and verbal learning) at three time points (after 6 weeks, 3 months, and 6 months of training). Possible investigated predictors were sociodemographic variables, depressive symptoms, number of training sessions, cognitive baseline values, and all interaction terms (group*predictor).
RESULTS
Being female was predictive for improvement in grammatical reasoning at 6 weeks in the GCT group, and lower cognitive baseline scores were predictive for improvement in spatial working memory and verbal learning at 6 months.
CONCLUSION
Our data indicate that predictors seem to change over time; remarkably, lower baseline performance at study entry is only a significant predictor at 6 months training. Possible reasons for these results are discussed in relation to the compensation hypothesis.",2020,"RESULTS
Being female was predictive for improvement in grammatical reasoning at 6 weeks in the GCT group, and lower cognitive baseline scores were predictive for improvement in spatial working memory and verbal learning at 6 months.
","['Data (N\xa0=\xa04184 healthy older individuals', 'healthy older adults', 'Healthy Older Adults']","['general cognitive training (GCT', 'Online RCT']","['sociodemographic variables, depressive symptoms, number of training sessions, cognitive baseline values, and all interaction terms (group*predictor', 'spatial working memory and verbal learning', 'grammatical reasoning', 'cognitive tasks (grammatical reasoning, spatial working memory, digit vigilance, paired association learning, and verbal learning']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",4184.0,0.0336916,"RESULTS
Being female was predictive for improvement in grammatical reasoning at 6 weeks in the GCT group, and lower cognitive baseline scores were predictive for improvement in spatial working memory and verbal learning at 6 months.
","[{'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Roheger', 'Affiliation': 'Department of Medical Psychology, Neuropsychology and Gender Studies & Center for Neuropsychological Diagnostics and Intervention (CeNDI), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Kalbe', 'Affiliation': 'Department of Medical Psychology, Neuropsychology and Gender Studies & Center for Neuropsychological Diagnostics and Intervention (CeNDI), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Corbett', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brooker', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, UK.'}]",International journal of geriatric psychiatry,['10.1002/gps.5322']
91,32360692,Acute and residual mood and cognitive performance of young adults following smoked cannabis.,"OBJECTIVES
To examine acute and residual mood and cognitive performance in young adult regular cannabis users following smoked cannabis.
METHODS
Ninety-one healthy young adults completed this double-blind, placebo-controlled, parallel-groups study. Participants were randomized to receive active (12.5% THC) or placebo cannabis with a 2:1 allocation ratio, and mood [Profile of Mood States (POMS)] and cognitive performance [Hopkins Verbal Learning Test - Revised (HVLT-R), Digit Symbol Substitution Test (DSST), Continuous Performance Test (CPT), grooved pegboard (GPB)] were assessed before and 1, 24, and 48 (h) after smoking cannabis ad libitum. High and Low THC groups were based on blood THC concentrations.
RESULTS
One hour after smoking cannabis, compared to Placebo, in both the High and Low THC groups, there were increases in POMS Arousal and Positive Mood, and in the High THC group only, increases in Confusion, Friendliness, and Elation, and a decrease in Fatigue. Increases in Friendliness and Elation in the High THC group remained significant for 24 h. The only significant acute effect of cannabis on cognition was a decrease in the percent of words retained in the HVLT-R in the High THC group compared to Placebo (mean difference = 15.8%, 95% CI = 3.6-28.0%, p = 0.006). Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
CONCLUSIONS
Under the present experimental conditions, in young regular cannabis users, smoking cannabis ad libitum had significant effects on mood, some of which persisted 24 h later, yet minimal effects on cognition, and no evidence of residual cognitive impairment.",2020,"Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
","['young adult regular cannabis users following smoked cannabis', 'Ninety-one healthy young adults', 'young adults following smoked cannabis', 'young regular cannabis users']","['High and Low', 'Placebo', 'placebo cannabis with a 2:1 allocation ratio, and mood', 'placebo']","['Confusion, Friendliness, and Elation', 'blood THC concentrations', 'Fatigue', 'Mood States (POMS)] and cognitive performance [Hopkins Verbal Learning Test - Revised (HVLT-R), Digit Symbol Substitution Test (DSST), Continuous Performance Test (CPT), grooved pegboard (GPB', 'Friendliness and Elation', 'Acute and residual mood and cognitive performance', 'POMS Arousal and Positive Mood', 'DSST performance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0233492', 'cui_str': 'Elation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3490329', 'cui_str': 'glycerol phenylbutyrate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",91.0,0.263829,"Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Matheson', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada. Electronic address: justin.matheson@camh.ca.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Mann', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Sproule', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S3M2, Canada; Pharmacy Department, Centre for Addiction and Mental Health, 1001 Queen Street, Toronto, Ontario M6J1H4, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Institute of Emerging Health Professions, Thomas Jefferson University, 1020 Walnut Street, Philadelphia, PA 19107, United States.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wickens', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Stoduto', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'George', 'Affiliation': ""Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario M6J1H4, Canada; Institute of Medical Sciences, University of Toronto, 1 King's College Circle, Room 2374, Toronto, Ontario M5S 1A8, Canada.""}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario M6J1H4, Canada; Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Department of Family and Community Medicine, University of Toronto, 500 University Avenue, 5th Floor, Toronto, Ontario M5G 1V7, Canada.""}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Controlled Substances and Cannabis Directorate, Health Canada, Ottawa, Ontario, Canada.""}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.172937']
92,32304911,"60 mg dose ticagrelor provides stronger platelet inhibition than clopidogrel in Chinese patients with chronic coronary syndrome: A randomized, single-blind, crossover study.",,2020,,['Chinese patients with chronic coronary syndrome'],"['clopidogrel', 'ticagrelor']",['platelet inhibition'],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.0257739,,"[{'ForeName': 'Meijiao', 'Initials': 'M', 'LastName': 'He', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Guangzhong', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Danghui', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China.""}, {'ForeName': 'Yihui', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China. Electronic address: kongyihui@126.com.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Cardiovascular Department, The First Affiliated Hospital, Harbin Medical University, Harbin, People's Republic of China; Institute of Metabolic Disease, Heilongjiang Academy of Medical Science, Harbin, People's Republic of China. Electronic address: ly99ly@vip.163.com.""}]",Thrombosis research,['10.1016/j.thromres.2020.03.014']
93,32304630,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30243-7.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30243-7'],[],[],[],[],,0.0193234,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30309-1']
94,32305926,Alpha Frequency Intervention by Electrical Stimulation to Improve Performance in Mu-Based BCI.,"The accuracy of brain-computer interfaces (BCIs) is important for effective communication and control. The mu-based BCI is one of the most widely used systems, of which the related methods to improve users' accuracy are still poorly studied, especially for the BCI illiteracy. Here, we examined a way to enhance mu-based BCI performance by electrically stimulating the ulnar nerve of the contralateral wrist at the alpha frequency (10 Hz) during left- and right-hand motor imagination in two BCI groups (literate and illiterate). We demonstrate that this alpha frequency intervention enhances the classification accuracy between left- and right-hand motor imagery from 66.41% to 81.57% immediately after intervention and to 75.28% two days after intervention in the BCI illiteracy group, while classification accuracy improves from 82.12% to 91.84% immediately after intervention and to 89.03% two days after intervention in the BCI literacy group. However, the classification accuracy did not change before and after the sham intervention (no electrical stimulation). Furthermore, the ERD on the primary sensorimotor cortex during left- or right-hand motor imagery tasks was more visible at the mu-rhythm (8-13 Hz) after alpha frequency intervention. Alpha frequency intervention increases the mu-rhythm power difference between left- and right-hand motor imagery tasks. These results provide evidence that alpha frequency intervention is an effective way to improve BCI performance by regulating the mu-rhythm which might provide a way to reduce BCI illiteracy.",2020,"Furthermore, the ERD on the primary sensorimotor cortex during left-or right-hand motor imagery tasks was more visible at the mu-rhythm (8-13 Hz) after alpha frequency intervention.",[],['Alpha Frequency Intervention by Electrical Stimulation'],"['enhance mu-based BCI performance', 'BCI performance']",[],"[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}]",,0.0148878,"Furthermore, the ERD on the primary sensorimotor cortex during left-or right-hand motor imagery tasks was more visible at the mu-rhythm (8-13 Hz) after alpha frequency intervention.","[{'ForeName': 'Xiangzi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yaqiu', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Boyu', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2987529']
95,32372382,Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Seven Phase 3 Randomized Controlled Trials.,"INTRODUCTION
The sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin is approved for the treatment of adults with type 2 diabetes mellitus (T2DM). This analysis was conducted on safety data pooled from phase 3 studies using ertugliflozin 5 mg or 15 mg versus placebo or an active comparator.
METHODS
The placebo pool (n = 1544) comprised data from three similarly designed 26-week placebo-controlled studies. The broad pool (n = 4849) comprised these three placebo-controlled studies plus four placebo- or active-controlled studies with treatment durations of up to 104 weeks.
RESULTS
In the placebo pool, there were no notable differences across groups in the incidence of adverse events (AEs), serious AEs, or AEs resulting in discontinuation from study medication, while associations were observed with genital mycotic infection in both females (3.0%, 9.1%, and 12.2% in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively) and males (0.4%, 3.7%, 4.2%), thirst (0.2%, 1.3%, 1.0%), and increased urination (1.0%, 2.7%, 2.4%). In the broad pool, volume depletion was increased with ertugliflozin in patients with estimated glomerular filtration rate < 60 ml/min/1.73 m 2 , aged ≥ 65 years, or who were taking diuretics. Ertugliflozin was not associated with increased urinary tract infection, fracture, hypoglycemia, pancreatitis, renal or hepatic injury, hypersensitivity, malignancy, or venous thromboembolism. Small numbers of patients were reported with lower limb amputation [0.1% (non-ertugliflozin group), 0.2% (ertugliflozin 5 mg), 0.5% (ertugliflozin 15 mg)]. There were three cases of ketoacidosis (all ertugliflozin 15 mg) and no cases of Fournier's gangrene.
CONCLUSION
This pooled analysis showed that ertugliflozin was generally well tolerated in a large population of patients with T2DM with and without moderate renal impairment who were taking a range of background diabetes medications including insulin and insulin secretagogs, with results that are generally consistent with those for other SGLT2 inhibitors.
TRIAL REGISTRATION
Clinicaltrials.gov indentifier, NCT02033889, NCT01958671, NCT02036515, NCT01986855, NCT02099110, NCT02226003, NCT01999218.",2020,"In the broad pool, volume depletion was increased with ertugliflozin in patients with estimated glomerular filtration rate < 60 ml/min/1.73 m 2 , aged ≥","['65\xa0years, or who were taking diuretics', 'pool (n\u2009=\u20091544', 'patients with T2DM with and without moderate renal impairment', 'adults with type 2 diabetes mellitus (T2DM', 'patients with estimated glomerular filtration rate\u2009<\u200960\xa0ml/min/1.73\xa0m 2 , aged ≥', 'Patients with Type 2 Diabetes Mellitus']","['Ertugliflozin', 'ertugliflozin', 'placebo, ertugliflozin', 'ertugliflozin 5\xa0mg or 15\xa0mg versus placebo', 'placebo-controlled studies plus four placebo', 'sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin', 'placebo']","['incidence of adverse events (AEs), serious AEs, or AEs resulting in discontinuation from study medication', 'urination', 'urinary tract infection, fracture, hypoglycemia, pancreatitis, renal or hepatic injury, hypersensitivity, malignancy, or venous thromboembolism', 'ketoacidosis', 'genital mycotic infection', 'limb amputation']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4535679', 'cui_str': 'ertugliflozin 5 MG'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C0002689', 'cui_str': 'Amputation of limb'}]",4849.0,0.435138,"In the broad pool, volume depletion was increased with ertugliflozin in patients with estimated glomerular filtration rate < 60 ml/min/1.73 m 2 , aged ≥","[{'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. shrita.patel@merck.com.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00803-3']
96,32376477,Effects of progressive resistance training prior to total HIP arthroplasty - a secondary analysis of a randomized controlled trial.,"OBJECTIVE
To investigate 1-year postoperative effect of preoperative resistance training (RT) in patients undergoing total hip arthroplasty (THA) on patient-reported outcomes on activity and function and objective outcomes on muscle strength and physical performance.
DESIGN
A 3-12 months follow-up of a randomized controlled trial. Patients scheduled for THA were randomized into: RT-group, twice a week for 10 weeks prior to THA, or 'care-as-usual' (CG). Primary endpoint of this sequel analysis is HOOS-ADL at 12 months follow-up. Secondary outcome measures are; other HOOS subscales, knee- and hip muscle strength plus function (gait, ascending/descending stairs, and sit-to-stand) at three and/or 12 months. CLINICALTRIALS.GOV: NCT01164111.
RESULTS
Eighty patients (70% women, 70.4 ± 7.6 years, BMI of 27.8 ± 4.6) were randomized to RT (n = 40) or CG (n = 40); data from 85% were available at 12 months. No superior effects were observed at 12 months for HOOS ADL (between-group change score [95%CI]) (2.6 [-4.2; 9.8], P = 0.44) or remaining subscales. However, ascending (1.3 s [0.3; 2.3], P = 0.01)) and descending stairs (1.6 s [0.3; 2.9], P = 0.01) demonstrated additional effects. At 3 months clinically relevant change-scores in favour of RT was observed on HOOS-Sport/Rec (10.5 points [1.4; 19.6], P = 0.023), together with higher knee strength of the affected side (14.6 Nm [6.3; 22.9], P < 0.001), and selected outcomes of physical function.
CONCLUSIONS
At 12 months after surgery, there was no additional effect of preoperative RT compared with THA alone, but rehabilitation was accelerated at 3 months.",2020,No superior effects were observed at 12 months for HOOS ADL (between-group change score [95%CI]) (,"['Patients scheduled for THA', 'patients undergoing total hip arthroplasty (THA', 'Eighty patients (70% women, 70.4 ± 7.6 years, BMI of 27.8 ± 4.6']","['THA', ""THA, or 'care-as-usual' (CG"", 'preoperative resistance training (RT', 'progressive resistance training']","['muscle strength and physical performance', 'HOOS subscales, knee- and hip muscle strength plus function (gait, ascending/descending stairs, and sit-to-stand', 'HOOS-ADL', 'knee strength', 'HOOS ADL']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517764', 'cui_str': '4.6'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",85.0,0.111012,No superior effects were observed at 12 months for HOOS ADL (between-group change score [95%CI]) (,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Holsgaard-Larsen', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark. Electronic address: ahlarsen@health.sdu.dk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hermann', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark; Department of Orthopedic Surgery, Herlev University Hospital, Denmark. Electronic address: ahermann@dadlnet.dk.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zerahn', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Herlev University Hospital, Denmark. Electronic address: Bo.Zerahn@regionh.dk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mejdahl', 'Affiliation': 'Department of Orthopedic Surgery, Herlev University Hospital, Denmark. Electronic address: Steen.Mejdahl@regionh.dk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark. Electronic address: Soeren.Overgaard@rsyd.dk.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.04.010']
97,32386593,"Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial.","BACKGROUND
Head-to-head trials in psoriatic arthritis are helpful in guiding clinical decision making. The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab as first-line biological monotherapy for 52 weeks in patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response.
METHODS
This parallel-group, double-blind, active-controlled, phase-3b, multicentre (168 sites in 26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis. Eligible patients were randomly assigned (1:1) by means of interactive response technology to receive secukinumab or adalimumab. Patients, investigators, site personnel, and those doing the assessments (except independent study drug administrators) were masked to study assignment. 300 mg secukinumab was administered subcutaneously at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 48 as a pre-filled syringe. Adalimumab was administered every 2 weeks from baseline until week 50 as 40 mg per 0·4 mL citrate free subcutaneous injection. The primary outcome was the proportion of patients with at least 20% improvement in the ACR response criteria (ACR20) at week 52. Patients were analysed according to the treatment to which they were randomly assigned. Safety analyses included all safety data reported up to and including the week 52 visit for each patient who received at least one dose of study drug. The trial is registered at ClinicalTrials.gov, NCT02745080.
FINDINGS
Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive secukinumab (n=426) or adalimumab (n=427). 709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50. 61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101 (24%) of 427 patients in the adalimumab group. The primary endpoint of superiority of secukinumab versus adalimumab for ACR20 response at week 52 was not met. 67% of patients in the secukinumab group achieved an ACR20 response at week 52 versus 62% of patients in the adalimumab group (OR 1·30, 95% CI 0·98-1·72; p=0·0719). The safety profiles of secukinumab and adalimumab were consistent with previous reports. Seven (2%) of 426 patients in the secukinumab group and six (1%) of 427 patients in the adalimumab group had serious infections. One death was reported in the secukinumab group due to colon cancer and was assessed as not related to the study drug by the investigator.
INTERPRETATION
Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52. However, secukinumab was associated with a higher treatment retention rate than adalimumab. This study provides comparative data on two biological agents with different mechanisms of action, which could help guide clinical decision making in the management of patients with psoriatic arthritis.
FUNDING
Novartis Pharma.",2020,"INTERPRETATION
Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52.","['26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis', 'Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive', '709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50', 'patients with psoriatic arthritis', '61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101', 'Eligible patients', 'patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response']","['adalimumab', 'interactive response technology to receive secukinumab or adalimumab', 'secukinumab (n=426) or adalimumab', 'secukinumab and adalimumab', 'Secukinumab versus adalimumab', 'Adalimumab', 'secukinumab', 'secukinumab versus adalimumab', 'mL citrate free subcutaneous injection']","['superiority of secukinumab versus adalimumab for ACR20 response', 'proportion of patients with at least 20% improvement in the ACR response criteria (ACR20', 'efficacy and safety', 'serious infections', 'ACR20 response']","[{'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",853.0,0.314879,"INTERPRETATION
Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52.","[{'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK. Electronic address: iain.mcinnes@glasgow.ac.uk.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': 'Rheumatology University Hospital and Fraunhofer Institute for Molecular Biology and Applied Ecology, Branch for Translational Medicine and Pharmacology and Fraunhofer Cluster of Excellence for Immune-Mediated Diseases, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Centre, Providence St Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'Rheumatology, Allergy, Immunology Division, University of California San Diego, School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ritchlin', 'Affiliation': 'Allergy, Immunology and Rheumatology Division, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Department of Medicine, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'Jordi Gratacós', 'Initials': 'JG', 'LastName': 'Masmitja', 'Affiliation': 'Rheumatology Department, University Hospital Parc Taulí, Sabadell, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology and INSERM-CIC1415, University Hospital of Tours, EA 7501 GICC, University of Tours, Tours, France.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Korotaeva', 'Affiliation': 'Research Institute of Rheumatology n.a. V A Nasonova, Moscow, Russia.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Ruvie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Pellet', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Shephard', 'Initials': 'S', 'LastName': 'Mpofu', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30564-X']
98,32387408,"A randomized, double-blind study to compare the efficacy and safety of two doses of mometasone furoate delivered via Breezhaler® or Twisthaler® in patients with asthma.","INTRODUCTION
Mometasone furoate (MF) is the inhaled corticosteroid (ICS) component in the long-acting β 2 -agonist (LABA)/ICS fixed-dose combination of indacaterol/MF, delivered via Breezhaler®, in development for asthma. MF at low (80 μg) and high (320 μg) doses delivered via Breezhaler® is expected to be comparable to MF at low (200 μg) and high (800 μg) doses respectively, delivered via Twisthaler®.
METHODS
This was a randomized, double-blind, double-dummy, four-week, parallel-group study of 739 adolescents and adults with persistent asthma. Eligible patients were receiving ICS treatment up to the maximum dose per day on a stable regimen for at least four weeks before screening. The study population was enriched for patients who were responsive to ICS therapy. The primary objective of the present study was to show non-inferiority of these doses, i.e. the low (80 μg) and high (320 μg) doses of MF delivered via Breezhaler® once daily, compared with the corresponding low (200 μg) and high (800 μg) doses of MF delivered via Twisthaler® once daily. The primary endpoint was 24 h post-dose trough forced expiratory volume in 1 s (FEV 1 ), after four weeks of treatment in patients with asthma. A secondary objective was to evaluate the efficacy of MF 80 μg and 320 μg delivered via Breezhaler®, and MF 200 μg and 800 μg delivered via Twisthaler® in terms of Asthma Control Questionnaire-5 (ACQ-5) after one, two, three and four weeks of treatment.
RESULTS
The LS mean difference in trough FEV 1 after four weeks of treatment between MF low dose 80 μg (Breezhaler®) and MF low dose 200 μg (Twisthaler®) was 27 mL (95% CI -34, 89); for MF high dose 320 μg (Breezhaler®) and MF high dose 800 μg (Twisthaler®) the difference was 0 mL (95% CI -60, 61). These differences were neither clinically nor statistically significant. All treatment arms provided similar clinically relevant improvements in ACQ-5 after four weeks of treatment compared with baseline. Both treatments showed a similar safety profile with a low incidence of adverse events.
CONCLUSION
The similarities in effects on lung function and ACQ after four weeks of treatment demonstrate the comparability of MF at low (80 μg) and high (320 μg) doses delivered with Breezhaler® with MF at low (200 μg) and high (800 μg) doses delivered with Twisthaler®, respectively. The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.",2020,"The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.","['739 adolescents and adults with persistent asthma', 'patients with asthma', 'patients who were responsive to ICS therapy']","['ICS', 'MF 80 μg and 320 μg delivered via Breezhaler®, and MF 200 μg and 800 μg delivered via Twisthaler®', 'Mometasone furoate (MF', 'MF high dose 800 μg (Twisthaler®', 'mometasone furoate delivered via Breezhaler® or Twisthaler®']","['ACQ-5', 'efficacy and safety', '24h post-dose trough forced expiratory volume in one second (FEV 1 ', 'lung function and ACQ']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",739.0,0.543909,"The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital, Mainz, Germany.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Hosoe', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Demin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bartels', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Jauernig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patalano', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hederer', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kanniess', 'Affiliation': 'Gemeinschaftspraxis Reinfeld, Reinfeld, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Tillmann', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland. Electronic address: hanns-christian.tillmann@novartis.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101919']
99,32353714,Music during image-guided breast biopsy reduces patient anxiety levels.,"PURPOSE
Interventions to decrease anxiety associated with image-guided breast biopsy are needed. Music intervention has been shown to be helpful in other outpatient procedural settings but data are limited regarding its effectiveness in the setting of breast biopsy. The purpose of this study was to determine whether listening to self-selected music during image-guided breast biopsy lowers anxiety.
MATERIALS AND METHODS
This randomized controlled trial was approved by the institutional review board and was HIPAA-compliant. 157 women between 18 and 75 (mean, 49.7 years) years of age, undergoing stereotactic or ultrasound-guided core biopsy, were enrolled in the study and were prospectively randomized to music or usual care. Patients in the music group listened to music of their choice during the biopsy. All patients completed the State Trait Anxiety Inventory (STAI) before and after the biopsy. Differences in pre-biopsy and post-biopsy anxiety levels were compared between the two groups using the Mann-Whitney U test.
RESULTS
Baseline trait anxiety scores in the two groups were similar (34.0 music, 31.5 control, p = .11). Patients in both groups showed lower state anxiety levels after the biopsy (45.6 to 34.3 music, 41.0 to 33.8 control, p < .001 for both). Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03). Post-biopsy anxiety levels were similar to normative values for working women in the same age group.
CONCLUSION
Listening to self-selected music reduces anxiety in patients undergoing breast biopsy.",2020,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","['patients undergoing breast biopsy', '157 women between 18 and 75 (mean, 49.7\xa0years) years of age, undergoing stereotactic or ultrasound-guided core biopsy']","['Music intervention', 'music or usual care', 'Listening to self-selected music', 'music group listened to music of their choice during the biopsy', 'Music during image-guided breast biopsy', 'listening to self-selected music during image-guided breast biopsy']","['anxiety', 'pre-biopsy and post-biopsy anxiety levels', 'state anxiety levels', 'Post-biopsy anxiety levels', 'Baseline trait anxiety scores', 'State Trait Anxiety Inventory (STAI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",157.0,0.0640536,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","[{'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Bennett', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America. Electronic address: Debbie.bennett@health.slu.edu.'}, {'ForeName': 'J Shannon', 'Initials': 'JS', 'LastName': 'Swan', 'Affiliation': 'MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Gazelle', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America; MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'Saksena', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America.'}]",Clinical imaging,['10.1016/j.clinimag.2020.03.018']
100,32357329,The safety and efficacy of anterior versus posterior decompression surgery in degenerative cervical myelopathy: a prospective randomized trial.,"OBJECTIVE
The safety and efficacy of anterior and posterior decompression surgery in degenerative cervical myelopathy (DCM) have not been validated in any prospective randomized trial.
METHODS
In this first prospective randomized trial, the patients who had symptoms or signs of DCM were randomly assigned to undergo either anterior cervical discectomy and fusion or posterior laminectomy with or without fusion. The primary outcome measures were the change in the visual analog scale (VAS) score, Neck Disability Index (NDI), and Nurick myelopathy grade 1 year after surgery. The secondary outcome measures were intraoperative and postoperative complications, hospital stay, and Odom's criteria. The follow-up period was at least 1 year.
RESULTS
A total of 68 patients (mean age 53 ± 8.3 years, 72.3% men) underwent prospective randomization. There was a significantly better outcome in the NDI and VAS scores in the anterior group at 1 year (p < 0.05). Nurick myelopathy grading showed nonsignificant improvement using the posterior approach group (p = 0.79). The mean operative duration was significantly longer in the anterior group (p < 0.001). No significant difference in postoperative complications was found, except postoperative dysphagia was significantly higher in the anterior group (p < 0.05). There was no significant difference in postoperative patient satisfaction (Odom's criteria) (p = 0.52). The mean hospital stay was significantly longer in the posterior group (p < 0.001).
CONCLUSIONS
Among patients with multilevel DCM, the anterior approach was significantly better regarding postoperative pain, NDI, and hospital stay, while the posterior approach was significantly better in terms of postoperative dysphagia and operative duration.",2020,There was no significant difference in postoperative patient satisfaction (Odom's criteria) (p = 0.52).,"['degenerative cervical myelopathy', 'degenerative cervical myelopathy (DCM', '68 patients (mean age 53 ± 8.3 years, 72.3% men) underwent prospective randomization', 'patients with multilevel DCM', 'patients who had symptoms or signs of DCM']","['anterior cervical discectomy and fusion or posterior laminectomy with or without fusion', 'anterior and posterior decompression surgery', 'anterior versus posterior decompression surgery']","['change in the visual analog scale (VAS) score, Neck Disability Index (NDI), and Nurick myelopathy grade 1 year after surgery', 'postoperative patient satisfaction', ""intraoperative and postoperative complications, hospital stay, and Odom's criteria"", 'postoperative dysphagia and operative duration', 'mean operative duration', 'NDI and VAS scores', 'safety and efficacy', 'mean hospital stay', 'postoperative complications', 'postoperative pain, NDI, and hospital stay', 'postoperative dysphagia']","[{'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0149645', 'cui_str': 'Cervical myelopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}]","[{'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",68.0,0.0649581,There was no significant difference in postoperative patient satisfaction (Odom's criteria) (p = 0.52).,"[{'ForeName': 'Nasser M F', 'Initials': 'NMF', 'LastName': 'El-Ghandour', 'Affiliation': ''}, {'ForeName': 'Mohamed A R', 'Initials': 'MAR', 'LastName': 'Soliman', 'Affiliation': ''}, {'ForeName': 'Ahmed A M', 'Initials': 'AAM', 'LastName': 'Ezzat', 'Affiliation': ''}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Mohsen', 'Affiliation': ''}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Zein-Elabedin', 'Affiliation': ''}]",Journal of neurosurgery. Spine,['10.3171/2020.2.SPINE191272']
101,32361220,Clinical impact of lung ultrasound monitoring for diagnosis of ventilator associated pneumonia: A diagnostic randomized controlled trial.,"PURPOSE
Studies have shown that lung-ultrasound may be superior to chest x-ray (CXR) in diagnosing ventilator-associated pneumonia (VAP). This study investigated whether the use of lung-ultrasound monitoring could detect VAP earlier and improve patient outcome.
METHODS
This was a single-center diagnostic randomized controlled trial. In the control group, VAP was diagnosed using a combination of CXR and clinical findings. In the intervention group, VAP was diagnosed using a combination of lung-ultrasound and clinical findings. The primary outcome measured was ventilator free days (VFD). Secondary outcomes were ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days.
RESULTS
We randomized intubated patients until 44 VAP diagnosis was made in each group. VFD was higher in the intervention group than in the control group (7.80+/- 9.7 days versus 3.7+/- 6.4 days, p = .044). There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70).
CONCLUSION
The use of lung-ultrasound monitoring for diagnosis of VAP improves patient outcome when compared to the standard diagnostic strategy that relies on CXR.",2020,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70).
",['diagnosis of ventilator associated pneumonia'],"['VAP', 'lung ultrasound monitoring', 'lung-ultrasound monitoring']","['ICU length of stay', 'delta SOFA', 'ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days', 'ICU mortality', 'antibiotic duration', 'ventilator free days (VFD', 'VFD']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.170703,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70).
","[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Pradhan', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal. Electronic address: saurabh_44@hotmail.com.'}, {'ForeName': 'Pramesh Sunder', 'Initials': 'PS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Gentle Sunder', 'Initials': 'GS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Moda Nath', 'Initials': 'MN', 'LastName': 'Marhatta', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.012']
102,32365870,Outcomes and Feasibility of a 12-Week Physical Literacy Intervention for Children in an Afterschool Program.,"Children ( N = 90) from eight afterschool programs ( n = 4 experimental sites with 47 children; n = 4 control sites with 43 children), along with the program leaders ( N = 7) from the experimental sites, participated in a 12-week physical literacy intervention. Children were assessed on their physical literacy (movement competence, affect, confidence, and motivation) pre- and post-intervention using a suite of assessment tools that included the PLAYfun assessment of movement competence and a comprehensive child questionnaire. Experimental participants engaged in a daily physical literacy intervention at their afterschool program; controls engaged in their usual afterschool programming. Experimental group program leaders were assessed on their cognitions pre- and post-training and post-intervention, alongside questions regarding program acceptability and feasibility. Program leaders' perceived knowledge and self-efficacy to implement the physical literacy program increased ( p < 0.05) from pre- to post-training and these effects were maintained at post-intervention. No group differences were observed in the change of children's motor competence, self-efficacy, or motivation from baseline to post-intervention. However, significant increases in affect were observed among participants in the experimental group ( p < 0.05). Program leaders said they would recommend the program to future leaders. However, they reported challenges with implementation due to equipment availability and behavioral challenges. Results suggest a comprehensive physical literacy program during the afterschool period can be feasible to implement and can lead to improvements in the affective domain of children's physical literacy. Further research on childhood physical literacy interventions is warranted.",2020,"No group differences were observed in the change of children's motor competence, self-efficacy, or motivation from baseline to post-intervention.","['Children ( N = 90) from eight afterschool programs ( n = 4 experimental sites with 47 children; n = 4 control sites with 43 children), along with the program leaders ( N = 7) from the experimental sites, participated in a 12-week', 'Children in an Afterschool Program']","['physical literacy intervention', '12-Week Physical Literacy Intervention', 'daily physical literacy intervention at their afterschool program; controls engaged in their usual afterschool programming']","['physical literacy (movement competence, affect, confidence, and motivation) pre', ""change of children's motor competence, self-efficacy, or motivation"", 'knowledge and self-efficacy', 'physical literacy program']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023865', 'cui_str': 'Literacy Programs'}]",,0.00973743,"No group differences were observed in the change of children's motor competence, self-efficacy, or motivation from baseline to post-intervention.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bremer', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, M5S 2W6, Canada.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Graham', 'Affiliation': 'INfant and Child Health (INCH) Lab, Department of Family Medicine, McMaster University, Hamilton, ON L8P 1H6, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cairney', 'Affiliation': 'School of Human Movement and Nutrition Sciences, University of Queensland, St Lucia 4072, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17093129']
103,32372454,The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials.,"It is unknown if the cardioprotective and renal effects of glucagon-like peptide-1 receptor agonists are consistent across blood pressure (BP) categories in patients with type 2 diabetes and at high risk of cardiovascular events. Using data from the LEADER (9340 patients) and SUSTAIN 6 (3297 patients) trials, we evaluated post hoc the cardiorenal effect of liraglutide and semaglutide on major adverse cardiovascular events (MACE) and nephropathy by baseline BP categories using a Cox proportional hazards model (treatment and subgroup as factors; adjusted for cardiorenal risk factors). Data from the two trials were analysed separately. In the LEADER and SUSTAIN 6 trials, the prevalence of stage 1 hypertension was 30% and 31%, respectively, and of stage 2 hypertension 41% and 43%, respectively. There was no statistical heterogeneity across the BP categories for the effects of liraglutide (P = .06 for MACE; P = .14 for nephropathy) or semaglutide (P = .40 for MACE; P = .27 for nephropathy) versus placebo. This implies that liraglutide and semaglutide may be beneficial for patients with type 2 diabetes, irrespective of their baseline BP.",2020,There was no statistical heterogeneity across the BP categories for the effects of liraglutide (p = 0.06 for MACE; p = 0.14 for nephropathy) or semaglutide (p = 0.40 for MACE; p = 0.27 for nephropathy) versus placebo.,"['9340 patients) and SUSTAIN 6 (3297 patients) trials', 'patients with type 2 diabetes and at high risk of cardiovascular events', 'patients with type 2 diabetes']","['LEADER', 'liraglutide', 'glucagon-like peptide-1 receptor agonists liraglutide and semaglutide', 'liraglutide and semaglutide', 'placebo']","['prevalence of stage 1 hypertension', 'major adverse cardiovascular events (MACE) and nephropathy by baseline BP categories', 'blood pressure (BP) categories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",9340.0,0.114719,There was no statistical heterogeneity across the BP categories for the effects of liraglutide (p = 0.06 for MACE; p = 0.14 for nephropathy) or semaglutide (p = 0.40 for MACE; p = 0.27 for nephropathy) versus placebo.,"[{'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Institute of Life Science, Swansea University, Swansea, UK.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center & Harvard Medical School , Boston, Massachusetts, USA.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Hospital Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Maria Sejersten', 'Initials': 'MS', 'LastName': 'Ripa', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Vrazic', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14079']
104,32379049,A Mobile Health Coaching Intervention for Controlling Hypertension: Single-Arm Pilot Pre-Post Study.,"BACKGROUND
The seminal Dietary Approaches to Stopping Hypertension (DASH) study demonstrated the effectiveness of diet to control hypertension; however, the effective implementation and dissemination of its principles have been limited.
OBJECTIVE
This study aimed to determine the feasibility and effectiveness of a DASH mobile health intervention. We hypothesized that combining Bluetooth-enabled data collection, social networks, and a human coach with a smartphone DASH app (DASH Mobile) would be an effective medium for the delivery of the DASH program.
METHODS
We conducted a single-arm pilot study from August 2015 through August 2016, using a pre-post evaluation design to evaluate the feasibility and preliminary effectiveness of a smartphone version of DASH that incorporated a human health coach. Participants were recruited both online and offline.
RESULTS
A total of 17 patients participated in this study; they had a mean age of 59 years (SD 6) and 10 (60%) were women. Participants were engaged with the app; in the 120 days of the study, the mean number of logged blood pressure measurements was 63 (SD 46), the mean number of recorded weight measurements was 52 (SD 45), and participants recorded a mean of 55 step counts (SD 36). Coaching phone calls had a high completion rate (74/102, 73%). The mean number of servings documented per patient for the dietary assessment was 709 (SD 541), and patients set a mean number of 5 (SD 2) goals. Mean systolic and diastolic blood pressure, heart rate, weight, body mass index, and step count did not significantly change over time (P>.10 for all parameters).
CONCLUSIONS
In this pilot study, we found that participants were engaged with an interactive mobile app that promoted healthy behaviors to treat hypertension. We did not find a difference in the physiological outcomes, but were underpowered to identify such changes.",2020,"Mean systolic and diastolic blood pressure, heart rate, weight, body mass index, and step count did not significantly change over time (P>.10 for all parameters).
","['participants were engaged with an interactive mobile app that promoted healthy behaviors to treat hypertension', '17 patients participated in this study; they had a mean age of 59 years (SD 6) and 10 (60%) were women']","['DASH mobile health intervention', 'Mobile Health Coaching Intervention', 'smartphone DASH app (DASH Mobile', 'smartphone version of DASH']","['Mean systolic and diastolic blood pressure, heart rate, weight, body mass index, and step count', 'mean number of logged blood pressure measurements', 'mean number of servings']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}]",17.0,0.129916,"Mean systolic and diastolic blood pressure, heart rate, weight, body mass index, and step count did not significantly change over time (P>.10 for all parameters).
","[{'ForeName': 'Himali', 'Initials': 'H', 'LastName': 'Weerahandi', 'Affiliation': 'Division of General Internal Medicine and Clinical Innovation, Department of Medicine, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Soaptarshi', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Quintiliani', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine, Boston, MA, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Chokshi', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Devin M', 'Initials': 'DM', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, NYU Grossman School of Medicine, New York, NY, United States.'}]",JMIR formative research,['10.2196/13989']
105,32375251,"Personal and Social Responsibility Programme Effects, Prosocial Behaviours, and Physical Activity Levels in Adolescents and Their Families.","The aim of this study was to analyse a personal and social responsibility programme in students and their family's perceptions relative to responsibility, prosocial behaviours, empathy, violence perception and physical activity levels. A sample consisting of 57 physical education students between 11 and 14 years old (mean (M) = 11.93; standard deviation (SD) = 0.73) that included 32 of their parents (M = 49.31; SD = 6.39) was distributed into experimental and control groups. The main results indicate that there were initial significant differences in favour of the control group for personal and social responsibility compared to the experimental group and they disappeared at the end of the treatment. There was an increase in antisocial behaviours for the control group at the end of the treatment. The experimental group also enhanced the values in violence perception for both students and families as compared to the control group. These results seem contradictory, which may be due in part to a short-time intervention programme and a low number of participants in the sample. More studies will clarify the improvements this kind of programme can bring to the variables studied.",2020,The main results indicate that there were initial significant differences in favour of the control group for personal and social responsibility compared to the experimental group and they disappeared at the end of the treatment.,"[""students and their family's"", 'Adolescents and Their Families', '57 physical education students between 11 and 14 years old (mean (M) = 11.93; standard deviation (SD) = 0.73) that included 32 of their parents (M = 49.31; SD = 6.39']",[],"['Personal and Social Responsibility Programme Effects, Prosocial Behaviours, and Physical Activity Levels', 'personal and social responsibility', 'perceptions relative to responsibility, prosocial behaviours, empathy, violence perception and physical activity levels', 'antisocial behaviours', 'values in violence perception']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",[],"[{'cui': 'C0037433', 'cui_str': 'Responsibility, Social'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0233523', 'cui_str': 'Antisocial behavior'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0167587,The main results indicate that there were initial significant differences in favour of the control group for personal and social responsibility compared to the experimental group and they disappeared at the end of the treatment.,"[{'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'García-García', 'Affiliation': 'Health, Physical Activity and Education (SAFE) Research Group, Sport Sciences Faculty, University of Murcia, 30720 Santiago de la Ribera, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Manzano-Sánchez', 'Affiliation': 'Department of Physical Activity and Sport, CEI Campus Mare Nostrum, University of Murcia, 30720 Santiago de la Ribera, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Belando-Pedreño', 'Affiliation': 'Faculty of Sports Science, Universidad Europea de Madrid, 28670 Villaviciosa de Odón, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Valero-Valenzuela', 'Affiliation': 'Department of Physical Activity and Sport, Sport Sciences Faculty, CEI Campus Mare Nostrum, University of Murcia, 30720 Santiago de la Ribera, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17093184']
106,32375328,Influence of Interval Training Frequency on Time-Trial Performance in Elite Endurance Athletes.,"PURPOSE
To determine the impact of interval training frequency in elite endurance athletes. It was hypothesized that two longer sessions would elicit greater performance improvements and physiological adaptation than four shorter sessions at the same intensity.
METHODS
Elite cross-country skiers and biathletes were randomly assigned to either a high-frequency group (HF group) (5 M, 1 F, age 22 (19-26), VO 2max 67.8 (65.5-70.2) mL/kg/min) doing four short interval sessions per week or a low-frequency group (LF group) (8 M, 1 F, age 22 (18-23), VO 2max 70.7 (67.0-73.9) mL/kg/min) doing two longer interval sessions. All interval sessions were performed at ~85% of maximum heart rate, and groups were matched for total weekly training volume. Pre- and post-intervention, athletes completed an 8 km rollerski time-trial, maximal oxygen uptake (VO 2max ) test, and an incremental, submaximal exercise test.
RESULTS
The LF group had a statistically significant improved time-trial performance following the intervention ( p = 0.04), with no statistically significant changes in the HF group. Similarly, percentage utilization of VO 2max at anaerobic threshold ( p = 0.04) and exercise economy ( p = 0.01) were statistically significantly improved following the intervention in the LF group only. No statistically significant changes in VO 2max were observed in either group.
CONCLUSIONS
Two longer interval sessions appear superior to four shorter sessions per week in promoting endurance adaptations and performance improvements in elite endurance athletes. Despite matched training volume and exercise intensity, the larger, more concentrated exercise stimulus in the LF group appears to induce more favorable adaptations. The longer time between training sessions in the LF group may also have allowed athletes to recover more effectively and better ""absorb"" the training. These findings are in line with the ""best practice"" observed by many of the world's best endurance athletes.",2020,"Similarly, percentage utilization of VO 2max at anaerobic threshold ( p = 0.04) and exercise economy ( p = 0.01) were statistically significantly improved following the intervention in the LF group only.","['Elite cross-country skiers and biathletes', 'Elite Endurance Athletes', 'elite endurance athletes']",['Pre- and post-intervention'],"['percentage utilization of VO 2max at anaerobic threshold', 'time-trial performance', 'maximal oxygen uptake (VO 2max ) test, and an incremental, submaximal exercise test', 'VO 2max', 'exercise economy', 'performance improvements and physiological adaptation']","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0425040', 'cui_str': 'Skier'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001400', 'cui_str': 'Adaptations, Physiological'}]",,0.041482,"Similarly, percentage utilization of VO 2max at anaerobic threshold ( p = 0.04) and exercise economy ( p = 0.01) were statistically significantly improved following the intervention in the LF group only.","[{'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Tønnessen', 'Affiliation': 'School of Health Sciences, Kristiana University College, 0153 Oslo, Norway.'}, {'ForeName': 'Jonny', 'Initials': 'J', 'LastName': 'Hisdal', 'Affiliation': 'Department of Vascular Investigations, Oslo University Hospital-Aker, 0586 Oslo, Norway.'}, {'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Ronnestad', 'Affiliation': 'Section for Health and Exercise Physiology, Inland Norway University, 2624 Lillehammer, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17093190']
107,32376313,A prospective randomized controlled trial comparing two different treatments of intrauterine adhesions.,"RESEARCH QUESTION
Intrauterine adhesions (IUA) are primarily caused by trauma to the endometrium, and hysteroscopy is presently the main treatment for IUA. However, high rates of post-operative adhesion re-formation remain a problem. In this study, the combination of an intrauterine device (IUD) with a Foley catheter and the balloon uterine stent were investigated to evaluate their efficacy in preventing adhesion re-formation and the subsequent reproductive outcomes in patients with moderate to severe adhesions.
DESIGN
A prospective randomized controlled study was conducted in a university-affiliated hospital. A total of 171 women with Asherman's syndrome were initially recruited between August 2016 and December 2017 and were randomized to undergo either balloon uterine stent insertion or placement of a contraceptive IUD plus a Foley catheter after hysteroscopic adhesiolysis. Reduction of adhesion scores, incidence of adhesion re-formation, changes in menstrual flow and reproductive outcomes were analysed.
RESULTS
A total of 118 participants were eligible for analysis. The American Fertility Society (AFS) scores were not significantly different between groups before hysteroscopic adhesiolysis. At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively). There were no statistically significant differences in pregnancy and live birth rates between the two groups.
CONCLUSIONS
The combination of an IUD and a Foley balloon catheter had better efficacy in preventing adhesion re-formation than the balloon uterine stent alone; however, it did not produce better reproductive outcomes.",2020,"At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively).","[""171 women with Asherman's syndrome were initially recruited between August 2016 and December 2017"", 'patients with moderate to severe adhesions', 'university-affiliated hospital', '118 participants were eligible for analysis']","['balloon uterine stent insertion or placement of a contraceptive IUD plus a Foley catheter', 'Foley balloon catheter', 'intrauterine device (IUD) with a Foley catheter and the balloon uterine stent']","['AFS scores and adhesion recurrence rates', 'American Fertility Society (AFS) scores', 'pregnancy and live birth rates', 'Reduction of adhesion scores, incidence of adhesion re-formation, changes in menstrual flow and reproductive outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156372', 'cui_str': 'Asherman syndrome'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",171.0,0.291661,"At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively).","[{'ForeName': 'Xiao-Wan', 'Initials': 'XW', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Meng-Meng', 'Initials': 'MM', 'LastName': 'Lin', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Hong-Qin', 'Initials': 'HQ', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Powell', 'Affiliation': 'Nottingham University Affiliated Hospital, Nottingham Treatment Centre, Nottingham NG7 2FT, UK.'}, {'ForeName': 'Yuan-Qiu', 'Initials': 'YQ', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Ru-Ru', 'Initials': 'RR', 'LastName': 'Zheng', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Laura Burney', 'Initials': 'LB', 'LastName': 'Ellis', 'Affiliation': 'Lister Hospital, Stevenage, Chelsea Bridge Road, London SW1W8RH, UK.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Xia', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China. Electronic address: 891225063@qq.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China. Electronic address: lin801026@163.com.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.02.013']
108,32376347,A pragmatic randomized trial of cardiopulmonary resuscitation training for families of cardiac patients before hospital discharge using a mobile application.,"AIM OF THE STUDY
Since over 80% of sudden cardiac arrests occur in the home, cardiopulmonary resuscitation (CPR) training for family members of high-risk cardiac patients represents a promising intervention. The use of mobile application-based (mApp) CPR training may facilitate this approach, but evidence regarding its efficacy is lacking.
METHODS
We conducted a multicenter, pragmatic, cluster-randomized trial assessing CPR training for family members of cardiac patients. The interventions were mApp (video, no manikin) and VSI (video + manikin). CPR skills were evaluated 6-months post-training. We hypothesized that chest compression (CC) rate from training with an mApp would be no worse than 5 compressions per minute (CPM) lower compared to VSI.
RESULTS
From 01/2016 to 01/2018, we enrolled 1325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white). CPR skills were evaluated 6-months post-training in 541 participants (275 VSI, 266 mApp). Mean rate was 84.6 CPM (95% CI: 80.4, 88.6) in VSI, compared to 82.7 CPM (95% CI: 76.2, 89.1) in the mApp, and mean depth was 42.1 mm (95% CI: 40.3, 43.8) in VSI, compared to 38.9 mm (95% CI: 36.2, 41.6) in the mApp. After adjustment, the mean difference in CC rate was -2.3 CPM (95% CI -9.4, 4.8, p = 0.25, non-inferiority) and CC depth was -3.2 mm (95% CI -5.9, 0.1, p = 0.056).
CONCLUSION
In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality. Future work is required to understand additional approaches to improve CPR skill retention.
CLINICAL TRIAL REGISTRATION
URL: ClinicalTrials.gov, Identifier: NCT02548793.",2020,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","['1,325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white', 'family members of cardiac patients', 'family members of high-risk cardiac patients', 'families of cardiac patients before hospital discharge using a mobile application']","['CPR training', 'cardiopulmonary resuscitation (CPR) training', 'cardiopulmonary resuscitation training', 'mobile application-based (mApp) CPR training']","['CPR skills', 'CC rate', 'Mean rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1325.0,0.173811,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","[{'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Blewer', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA. Electronic address: Audrey.blewer@duke.edu.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Putt', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Shaun K', 'Initials': 'SK', 'LastName': 'McGovern', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA.'}, {'ForeName': 'Raina M', 'Initials': 'RM', 'LastName': 'Merchant', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Resuscitation,['10.1016/j.resuscitation.2020.04.026']
109,32382714,"A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in Mycobacterium tuberculosis -uninfected adolescents in Cape Town, South Africa.","Background
Tuberculosis (TB) remains the leading cause of infectious disease-related death. Recently, a trial of BCG revaccination and vaccination with H4:IC31, a recombinant protein vaccine, in South African adolescents (Aeras C-040-404) showed efficacy in preventing sustained QuantiFERON (QFT) conversion, a proxy for Mycobacterium tuberculosis ( M.tb ) infection. A phase 1b trial of 84 South African adolescents was conducted, concurrent with Aeras C-040-404, to assess the safety and immunogenicity of H4:IC31, H56:IC31 and BCG revaccination, and to identify and optimize immune assays for identification of candidate correlates of protection in efficacy trials.
Methods
Two doses of H4:IC31 and H56:IC31 vaccines were administered intramuscularly (IM) 56 days apart, and a single dose of BCG (2-8 × 10 5 CFU) was administered intradermally (ID). T-cell and antibody responses were measured using intracellular cytokine staining and binding antibody assays, respectively. Binding antibodies and CD4+/CD8+ T-cell responses to H4- and H56-matched antigens were measured in samples from all participants. The study was designed to characterize safety and immunogenicity and was not powered for group comparisons. (Clinicaltrials.gov NCT02378207).
Findings
In total, 481 adolescents (mean age 13·9 years) were screened; 84 were enrolled (54% female). The vaccines were generally safe and well-tolerated, with no reported severe adverse events related to the study vaccines. H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies. The highest vaccine-induced CD4+ T-cell response rates were for those recognizing Ag85B in the H4:IC31 and H56:IC31 vaccinated groups. BCG revaccination elicited robust, polyfunctional BCG-specific CD4+ T cells, with no increase in H4- or H56-specific IgG binding antibodies. There were few antigen-specific CD8+ T-cell responses detected in any group.
Interpretation
BCG revaccination administered as a single dose ID and both H4:IC31 and H56:IC31 administered as 2 doses IM had acceptable safety profiles in healthy, QFT-negative, previously BCG-vaccinated adolescents. Characterization of the assays and the immunogenicity of these vaccines may help to identify valuable markers of protection for upcoming immune correlates analyses of C-040-404 and future TB vaccine efficacy trials.
Funding
NIAID and Aeras.",2020,H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies.,"['Mycobacterium tuberculosis -uninfected adolescents in Cape Town, South Africa', '84 South African adolescents', 'South African adolescents', '481 adolescents (mean age 13·9 years) were screened; 84 were enrolled (54% female']","['H4:IC31, H56:IC31, and BCG revaccination', 'H4:IC31 and H56:IC31 vaccines', 'H4:IC31 and H56:IC31', 'H4:IC31, a recombinant protein vaccine']","['antigen-specific CD8+ T-cell responses', 'severe adverse events', 'highest vaccine-induced CD4+ T-cell response rates', 'T-cell and antibody responses', 'BCG revaccination elicited robust, polyfunctional BCG-specific CD4+ T cells', 'safety and immunogenicity', 'safe and well-tolerated', 'H4- or H56-specific']","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034861', 'cui_str': 'Recombinant protein'}]","[{'cui': 'C0456981', 'cui_str': 'Specific antigen'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",84.0,0.0974093,H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies.,"[{'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Dintwe', 'Affiliation': 'Cape Town HVTN Immunology Laboratory, Cape Town, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fiore-Gartland', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Middelkoop', 'Affiliation': 'The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'April K', 'Initials': 'AK', 'LastName': 'Randhawa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Ruhwald', 'Affiliation': 'Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kromann', 'Affiliation': 'Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Andersen', 'Affiliation': 'Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, United States.'}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Rutkowski', 'Affiliation': 'Aeras, Rockville, MD, United States.'}, {'ForeName': 'Dereck', 'Initials': 'D', 'LastName': 'Tait', 'Affiliation': 'Aeras, Cape Town, South Africa.'}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Andersen-Nissen', 'Affiliation': 'Cape Town HVTN Immunology Laboratory, Cape Town, South Africa.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Seaton', 'Affiliation': 'Duke Human Vaccine Institute, Departments of Surgery, Immunology, and Molecular Genetics and Microbiology, Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Departments of Surgery, Immunology, and Molecular Genetics and Microbiology, Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ginsberg', 'Affiliation': 'Aeras, Rockville, MD, United States.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100313']
110,32383337,Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial.,"OBJECTIVE
The aim of this article is to describe the incidence and characteristics of pregnancy-related death in low- and middle-resource settings, in relation to the availability of key obstetric resources.
DESIGN
This is a secondary analysis of a stepped-wedge cluster randomised controlled trial.
SETTING
This trial was undertaken at ten sites across eight low- and middle-income countries in sub-Saharan Africa, India and Haiti.
POPULATION
Institutional-level consent was obtained and all women presenting for maternity care were eligible for inclusion.
METHODS
Pregnancy-related deaths were collected prospectively from routine data sources and active case searching.
MAIN OUTCOME MEASURES
Pregnancy-related death, place, timing and age of maternal death, and neonatal outcomes in women with this outcome.
RESULTS
Over 20 months, in 536 233 deliveries there were 998 maternal deaths (18.6/10 000, range 28/10 000-630/10 000). The leading causes of death were obstetric haemorrhage (36.0%, n = 359), hypertensive disorders of pregnancy (20.6%, n = 206), sepsis (14.1%, n = 141) and other (26.5%, n = 264). Approximately a quarter of deaths occurred prior to delivery (28.4%, n = 283), 35.7% (n = 356) occurred on the day of delivery and 35.9% (n = 359) occurred after delivery. Half of maternal deaths (50.6%; n = 505) occurred in women aged 20-29 years, 10.3% (n = 103) occurred in women aged under 20 years, 34.5% (n = 344) occurred in women aged 30-39 years and 4.6% (n = 46) occurred in women aged ≥40 years. There was no measured association between the availability of key obstetric resources and the rate of pregnancy-related death.
CONCLUSIONS
The large variation in the rate of pregnancy-related death, irrespective of resource availability, emphasises that inequality and inequity in health care persists.
TWEETABLE ABSTRACT
Inequality and inequity in pregnancy-related death persists globally, irrespective of resource availability.",2020,"Approximately a quarter of deaths occurred prior to delivery (28.4%, n=283), 35.7% on the day of delivery (n=356) and 35.9% after delivery (n=359).","['Pregnancy-related deaths were prospectively collected from routine data sources and active case finding', '10 sites across eight low and middle-income countries in sub-Saharan Africa, India and Haiti', 'Half of maternal deaths (50.6%; n=505) occurred in women aged 20-29, 10.3% under 20 years (n=103), 34.5% aged 30-39 (n=344) and 4.6% (n=46) aged ≥40', 'women presenting for maternity care were eligible for inclusion']",[],"['Incidence and characteristics of pregnancy-related death', '998 maternal deaths', 'availability of key obstetric resources and the rate of pregnancy-related death', 'Pregnancy-related death, place, timing and age of maternal death and neonatal outcomes', 'sepsis', 'hypertensive disorders of pregnancy']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011001', 'cui_str': 'Data Sources'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}]",,0.351709,"Approximately a quarter of deaths occurred prior to delivery (28.4%, n=283), 35.7% on the day of delivery (n=356) and 35.9% after delivery (n=359).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Holmes', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Gidiri', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chinkoyo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ndola Teaching Hospital, Ndola, Zambia.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Kumsa', 'Affiliation': 'Maternity Worldwide, Brighton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Maternity Worldwide, Brighton, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Charantimath', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bellad', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nakimuli', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16309']
111,32379608,The Impact of Childhood Maltreatment on Long-Term Outcomes in Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression.,"BACKGROUND
Childhood maltreatment (CM) predicted poorer outcomes in acute depression treatment with CBT, IPT and Supportive Psychotherapy (SP). The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) fared well in patients with chronic depression and CM during acute treatment, yet there is a considerable lack of empirical evidence for long-term outcomes.
METHODS
We analyzed one and two-year follow-up data of 268 patients randomized to 24 sessions (20 weeks) of acute and 8 sessions (28 weeks) of extended treatment with CBASP or SP. Primary outcome was the number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE). Secondary outcomes included self- and clinician-rated depression symptoms. We investigated this moderating effect for any CM and for specific subtypes of CM.
RESULTS
Intent-to-treat analyses revealed that the presence of CM did not significantly moderate long-term effects of CBASP compared to SP. The analysis of trauma subtypes revealed that patients with childhood emotional abuse had statistically significant worse outcomes than patients without (main effect, p=.015) and that the advantage of CBASP over SP was larger in patients with childhood emotional abuse than in patients without (interaction effect, p=.045) after 1 year. No significant effects were found for other trauma subtypes.
LIMITATIONS
The measurement of CM was limited to retrospective self-assessment.
CONCLUSIONS
The presence of CM did not significantly moderate long-term treatment effects of CBASP compared to SP. When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.",2020,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","['Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression', 'patients with chronic depression and CM during acute treatment']","['CBT, IPT and Supportive Psychotherapy (SP', 'Psychotherapy (CBASP', 'CBASP', 'CBASP or SP']","['number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE', 'self- and clinician-rated depression symptoms']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",268.0,0.144678,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bausch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: paul.bausch@gmx.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fangmeier', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Meister', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Elsaeßer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Zobel', 'Affiliation': 'Psychology School at the Fresenius University of Applied Sciences Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.164']
112,32379667,Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19.,"BACKGROUND
Patients with Coronavirus Disease 2019(COVID-19) will experience high levels of anxiety and low sleep quality due to isolation treatment. Some sleep-improving drugs may inhibit the respiratory system and worsen the condition. Prolonged bedside instruction may increase the risk of medical infections.
OBJECTIVE
To investigate the effect of progressive muscle relaxation on anxiety and sleep quality of COVID-19.
METHODS
In this randomized controlled clinical trial, a total of 51 patients who entered the isolation ward were included in the study and randomly divided into experimental and control groups. The experimental group used progressive muscle relaxation (PMR) technology for 30 min per day for 5 consecutive days. During this period, the control group received only routine care and treatment. Before and after the intervention, the Spielberger State-Trait Anxiety Scale (STAI) and Sleep State Self-Rating Scale (SRSS) were used to measure and record patient anxiety and sleep quality. Finally, data analysis was performed using SPSS 25.0 software.
RESULTS
The average anxiety score (STAI) before intervention was not statistically significant (P = 0.730), and the average anxiety score after intervention was statistically significant (P < 0.001). The average sleep quality score (SRSS) of the two groups before intervention was not statistically significant (P = 0.838), and it was statistically significant after intervention (P < 0.001).
CONCLUSION
Progressive muscle relaxation as an auxiliary method can reduce anxiety and improve sleep quality in patients with COVID-19.",2020,"The average anxiety score (STAI) before intervention was not statistically significant (P = 0.730), and the average anxiety score after intervention was statistically significant (P < 0.001).","['patients with COVID-19', '51 patients who entered the isolation ward', 'Patients with Coronavirus Disease 2019(COVID-19']","['progressive muscle relaxation (PMR) technology', 'progressive muscle relaxation', 'Prolonged bedside instruction']","['anxiety and sleep quality', 'average sleep quality score (SRSS', 'average anxiety score (STAI', 'anxiety and sleep quality of COVID-19', 'patient anxiety and sleep quality', 'Spielberger State-Trait Anxiety Scale (STAI) and Sleep State Self-Rating Scale (SRSS', 'sleep quality', 'average anxiety score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",51.0,0.0217776,"The average anxiety score (STAI) before intervention was not statistically significant (P = 0.730), and the average anxiety score after intervention was statistically significant (P < 0.001).","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Health Care Center, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China. Electronic address: hmliukai@163.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Laboratory, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}, {'ForeName': 'Duozhi', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Health Care Center, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}, {'ForeName': 'Ruzheng', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of General Practice, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}, {'ForeName': 'Zaisheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of General Practice, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}, {'ForeName': 'Liqing', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'Department of General Practice, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101132']
113,32388857,"Assisted breastfeeding technique to improve knowledge, attitude, and practices of mothers with cleft lip- and palate-affected infants: A randomized trial.","BACKGROUND
Cleft lip and palate is one of the most common developmental anomalies affecting the craniofacial region leading to an array of problems including the inability to feed properly.
OBJECTIVES
This study aimed to compare the effectiveness of specially designed audio-visual module over traditional instructional module in improving the assisted breastfeeding habits.
METHODOLOGY
Sixteen patients received training regarding the feeding practices through the traditional instructional method, and 16 subjects received training through audio-visual module. Infants in both the groups received the standard care. These infants were followed up longitudinally for 6 months. During the follow up period, the growth parameters were recorded monthly. The knowledge, attitude, and practices of the mothers regarding feeding practices were assessed using KAP questionnaire.
RESULTS
There was significant improvement in the knowledge of the mothers from baseline to 6 months, however, the practices indicated that the mothers belonging to the audio-visual module group showed better understating of the condition and earlier adaptation of the breastfeeding practices. Correspondingly, the growth parameters also showed significant difference.
CONCLUSION
The custom-made audio-visual module would help the mothers adapt better to the stressful situation following the birth of the infant affected with cleft lip and palate.",2020,"There was significant improvement in the knowledge of the mothers from baseline to 6 months, however, the practices indicated that the mothers belonging to the audio-visual module group showed better understating of the condition and earlier adaptation of the breastfeeding practices.","['Sixteen patients received', 'mothers with cleft lip- and palate-affected infants']","['training regarding the feeding practices through the traditional instructional method, and 16 subjects received training through audio-visual module', 'specially designed audio-visual module over traditional instructional module', 'Assisted breastfeeding technique']",[],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],16.0,0.0277095,"There was significant improvement in the knowledge of the mothers from baseline to 6 months, however, the practices indicated that the mothers belonging to the audio-visual module group showed better understating of the condition and earlier adaptation of the breastfeeding practices.","[{'ForeName': 'Prashanth Sadashiva', 'Initials': 'PS', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}, {'ForeName': 'Srinivasa', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatrics, JSS Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12464']
114,32389013,mRNA expression disturbance of complement system related genes in acute arterial thrombotic and paroxysmal atrial fibrillation patients.,"BACKGROUND
This study aimed to compare the characteristics of mRNA expression of genes in complement system between acute arterial thrombotic patients and paroxysmal atrial fibrillation (PAF) patients.
METHODS
Twenty acute myocardial infarction (AMI) patients and 20 PAF patients were assigned into the experiment groups, and 20 stable angina pectoris (SAP) patients were enrolled in the control group.
RESULTS
When compared with the control group, mRNA expression of C1QA, C1QB, C1QC, C1R, CFP, C5, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CD46, CD55 and CD59 genes was significantly upregulated, and CR2 gene significantly downregulated in the AMI group (P<0.05); while mRNA expression of CFD, MBL2, MASP2, C5, C6, C8B, C9, C5AR1, CR2, CFI, CFHR1, CD46, CD55, VTN and CD59 genes was significantly downregulated in PAF patients (P<0.05). Results of the comparison between the AMI and PAF group showed that mRNA expression of C1QA, C1QB, C1QC, C1R, CFB, CFD, CFP, MBL2, MASP2, C5, C6, C8B, C9, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CFI, CFHR1, CD46, CD55, CLU, VTN and CD59 genes was significantly upregulated in the AMI group (P<0.05).
CONCLUSIONS
Taken SAP patients as controls, the complement system is in a high-intensive disturbance with simultaneous activation and inhibition in AMI patients, indicating that the cascade response of complement system is disturbed, and then the membrane attack complex (MAC) cannot form finally. The mRNA expression of related genes in the complement system is under a status of downregulation in PAF patients, indicating that the functions of cascade response in the complement system decreased significantly in PAF patients, leading to significantly decreased MAC functions.",2020,"When compared with the control group, mRNA expression of C1QA, C1QB, C1QC, C1R, CFP, C5, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CD46, CD55 and CD59 genes was significantly upregulated, and CR2 gene significantly downregulated in the AMI group (P<0.05); while mRNA expression of CFD, MBL2, MASP2, C5, C6, C8B, C9, C5AR1, CR2, CFI, CFHR1, CD46, CD55, VTN and CD59 genes was significantly downregulated in PAF patients (P<0.05).","['acute arterial thrombotic patients and paroxysmal atrial fibrillation (PAF) patients', 'Twenty acute myocardial infarction (AMI) patients and 20 PAF patients were assigned into the experiment groups, and 20 stable angina pectoris (SAP) patients were enrolled in the control group', 'acute arterial thrombotic and paroxysmal atrial fibrillation patients']",[],"['CR2 gene', 'mRNA expression of C1QA, C1QB, C1QC, C1R, CFB, CFD, CFP, MBL2, MASP2, C5, C6, C8B, C9, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CFI, CFHR1, CD46, CD55, CLU, VTN and CD59 genes', 'mRNA expression of CFD, MBL2, MASP2, C5, C6, C8B, C9, C5AR1, CR2, CFI, CFHR1, CD46, CD55, VTN and CD59 genes', 'mRNA expression of C1QA, C1QB, C1QC, C1R, CFP, C5, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CD46, CD55 and CD59 genes', 'MAC functions']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0056184', 'cui_str': 'Lymphocyte antigen CD21'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0009002', 'cui_str': 'Clofibrate'}, {'cui': 'C1562113', 'cui_str': 'Fleck corneal dystrophy'}, {'cui': 'C0055162', 'cui_str': 'CFP protocol'}, {'cui': 'C0056182', 'cui_str': 'Complement receptor CRI'}, {'cui': 'C1701032', 'cui_str': 'ITGAM protein, human'}, {'cui': 'C0055288', 'cui_str': 'Chemotaxis factor inhibitor'}, {'cui': 'C0285488', 'cui_str': 'Lymphocyte antigen CD46'}, {'cui': 'C0108793', 'cui_str': 'Decay accelerating factor'}, {'cui': 'C0054966', 'cui_str': 'Lymphocyte antigen CD59'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",20.0,0.0171834,"When compared with the control group, mRNA expression of C1QA, C1QB, C1QC, C1R, CFP, C5, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CD46, CD55 and CD59 genes was significantly upregulated, and CR2 gene significantly downregulated in the AMI group (P<0.05); while mRNA expression of CFD, MBL2, MASP2, C5, C6, C8B, C9, C5AR1, CR2, CFI, CFHR1, CD46, CD55, VTN and CD59 genes was significantly downregulated in PAF patients (P<0.05).","[{'ForeName': 'Siwan', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Cardiology, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China.'}, {'ForeName': 'Lemin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China. wanglemin2003@163.com.'}]",Annals of palliative medicine,['10.21037/apm.2020.04.18']
115,32389050,Necessity of Interfragmentary Lag Screws in Precontoured Lateral Locking Plate Fixation for Supination-External Rotation Lateral Malleolar Fractures.,"BACKGROUND
Interfragmentary lag screws, protected by a plate, have been applied for many years in the treatment of supination-external rotation (SER) ankle fractures. Recently, similar biomechanical stability was found between fixation completed with a plate and lag screw and a plate alone. The aim of this study was to determine whether interfragmentary lag screws are necessary during precontoured lateral locking plate fixation for SER lateral malleolar fractures.
METHODS
A prospective randomized controlled trial of 76 patients with unilateral Lauge-Hansen SER lateral malleolar fractures was conducted. The patients were randomly treated either with or without the use of interfragmentary lag screws with precontoured lateral locking plate fixation. Clinical outcomes were assessed using the Olerud-Molander Ankle Score and a visual analog scale for pain. Radiologic outcomes were assessed based on the Kellgren and Lawrence scale score, incongruity of the ankle joint, and type of fracture healing. Sixty-nine patients completed 12 months of follow-up.
RESULTS
There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery. All patients in both groups achieved primary bone healing.
CONCLUSION
The results of this study suggest that with precontoured lateral locking plate fixation, the use of interfragmentary lag screw is not essential in the treatment SER lateral malleolar fractures.
LEVEL OF EVIDENCE
Level I, prospective randomized study.",2020,There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery.,"['76 patients with unilateral Lauge-Hansen SER lateral malleolar fractures', 'Sixty-nine patients completed 12 months of follow-up', 'Supination-External Rotation Lateral Malleolar Fractures']","['precontoured lateral locking plate fixation', 'Interfragmentary Lag Screws in Precontoured Lateral Locking Plate Fixation', 'interfragmentary lag screws with precontoured lateral locking plate fixation']","['Radiologic outcomes', 'biomechanical stability', 'Olerud-Molander Ankle Score and a visual analog scale for pain', 'Kellgren and Lawrence scale score, incongruity of the ankle joint, and type of fracture healing', 'primary bone healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023343', 'cui_str': 'Leprosy'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1096630', 'cui_str': 'Malleolar fracture'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}]",76.0,0.0331161,There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery.,"[{'ForeName': 'Young Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Cho', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Gi Won', 'Initials': 'GW', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Ansan Hospital, Seoul, Korea.'}, {'ForeName': 'Hak Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}]",Foot & ankle international,['10.1177/1071100720917645']
116,32389679,Randomized controlled trial evaluating an intervention supporting implementation of sun safety policies in California public elementary schools.,"Solar ultraviolet radiation (UV) exposure is the primary risk factor for skin cancer and children receive about one-quarter of lifetime UV exposure before age 18. Thus, skin cancer prevention is essential for children. The objective of this study was to test an intervention to facilitate implementation of district sun safety policies. Elementary schools (N = 118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school. Elementary schools were randomly assigned to receive the 20-month Sun Safe Schools intervention (N = 58) or to a minimal informational control condition (N = 60). Principals were 47.8 and teachers 44.3 years of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2%). The 20-month Sun Safe Schools intervention was delivered to principals and included a coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program. The principal (N = 118) and a teacher (N = 113) at each school reported on school sun protection practices 20-months post-baseline. The schools were diverse in student characteristics (M = 64.1% free/reduced price meals; M = 54.5% Hispanic). Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control M = 0.4, intervention M = 0.9, p = .005). Principals and teachers combined replicated these findings and also reported implementing more practices present in the district policy (control M = 0.9, intervention M = 1.3, p = .005). In sum, the intervention increased sun safety practices in public elementary schools. Trial Registration. This study is registered in ClinicalTrials.gov, www.clinicaltrials.gov, with the identification number of NCT03243929.",2020,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","['Principals were 47.8 and teachers 44.3\u202fyears of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2', 'California public elementary schools', 'Elementary schools (N\u202f=\u202f118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school', 'Elementary schools']","['Solar ultraviolet radiation (UV) exposure', '20-month Sun Safe Schools intervention (N\u202f=\u202f58) or to a minimal informational control condition', 'coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program']","['sun safety practices', 'sun safety practices overall']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0636129,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","[{'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Reynolds', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA. Electronic address: Kim.Reynolds@cgu.edu.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Massie', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Ashley', 'Affiliation': 'Sun Safety for Kids, 2625 W. Alameda Ave., Suite 517, Burbank, CA 91505, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR 97227, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106125']
117,32389735,Preoperative Gabapentin for Minimally Invasive Hysterectomy: A Randomized Controlled Trial.,"STUDY OBJECTIVE
To evaluate whether a single dose of gabapentin given preoperatively reduces narcotic use 24 hours after minimally invasive hysterectomy (MIH).
DESIGN
Randomized controlled trial.
SETTING
Single academic-affiliated community hospital.
PATIENTS
Women undergoing MIH for benign indications between June 2016 and June 2017.
INTERVENTIONS
Subjects were randomized to receive a preoperative regimen of acetaminophen, celecoxib, and gabapentin versus acetaminophen and celecoxib alone.
MEASUREMENTS AND MAIN RESULTS
The primary outcome assessed was the total amount of narcotics used at 24 hours after surgery. Secondary outcomes included adverse effects from gabapentin use, total narcotics used, and pain scores at 2 weeks after surgery. A total of 129 women were randomized and eligible for analysis in the gabapentin study arm (n = 68) or the control arm (n = 61). Demographic characteristics and surgical details were similar between groups. Narcotics used at 24 hours after surgery totaling 168 versus 161 oral morphine milligram equivalents in the gabapentin and control groups, respectively, did not significantly differ between groups (p = .60). Total narcotics used and pain scores at 2 weeks after surgery and the rates of adverse effects from gabapentin were also similar between study arms.
CONCLUSION
Single-dose, preoperative gabapentin for women undergoing benign MIH does not reduce total opioid use 24 hours after surgery.",2020,"Single-dose, preoperative gabapentin for women undergoing benign minimally invasive hysterectomy does not reduce total opioid use 24 hours after surgery.","['A total of 129 women were randomized and eligible for analysis in the gabapentin study arm (n=68) or the control arm (n=61', 'Single academic-affiliated community hospital', 'Women undergoing MIH for benign indications between June 2016 and June 2017', 'women undergoing benign minimally invasive hysterectomy', 'minimally invasive hysterectomy (MIH']","['morphine milliequivalents', 'gabapentin', 'acetaminophen, celecoxib, and gabapentin versus acetaminophen and celecoxib alone', 'preoperative gabapentin']","['total amount of narcotic', 'Total narcotic use and pain scores', 'Demographic characteristics and surgical details', 'adverse effects from gabapentin use, total narcotic use, and pain scores', 'rates of adverse effects']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439152', 'cui_str': 'mEq'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]",129.0,0.29268,"Single-dose, preoperative gabapentin for women undergoing benign minimally invasive hysterectomy does not reduce total opioid use 24 hours after surgery.","[{'ForeName': 'Terri Q', 'Initials': 'TQ', 'LastName': 'Huynh', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecology, Christiana Care Health Systems, Newark, Delaware (Drs. Huynh, Patel, and Makai); Department of Epidemiology and Biostatistics, Drexel University Dornsife School of Public Health, Philadelphia, Pennsylvania (Dr. Goldstein). Electronic address: terri.huynh@christianacare.org.'}, {'ForeName': 'Nima R', 'Initials': 'NR', 'LastName': 'Patel', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecology, Christiana Care Health Systems, Newark, Delaware (Drs. Huynh, Patel, and Makai); Department of Epidemiology and Biostatistics, Drexel University Dornsife School of Public Health, Philadelphia, Pennsylvania (Dr. Goldstein).'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Goldstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecology, Christiana Care Health Systems, Newark, Delaware (Drs. Huynh, Patel, and Makai); Department of Epidemiology and Biostatistics, Drexel University Dornsife School of Public Health, Philadelphia, Pennsylvania (Dr. Goldstein).'}, {'ForeName': 'Gretchen E', 'Initials': 'GE', 'LastName': 'Makai', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecology, Christiana Care Health Systems, Newark, Delaware (Drs. Huynh, Patel, and Makai); Department of Epidemiology and Biostatistics, Drexel University Dornsife School of Public Health, Philadelphia, Pennsylvania (Dr. Goldstein).'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.04.040']
118,32353573,Sick days in general hospital patients two years after brief alcohol intervention: Secondary outcomes from a randomized controlled trial.,"Little is known about the long-term impact of brief alcohol interventions (BAIs) on health and on sick days in particular. The aim was to investigate whether BAIs reduce sick days in general hospital patients over two years, and whether effects depend on how BAIs are delivered; either through in-person counseling (PE) or computer-generated written feedback (CO). To investigate this, secondary outcome data from a three-arm randomized controlled trial with 6-, 12-, 18- and 24-month follow-ups were used. The sample included 960 patients (18-64 years) with at-risk alcohol use identified through systematic screening on 13 hospital wards. Patients with particularly severe alcohol problems were excluded. Participants were allocated to PE, CO and assessment only (AO). Both interventions were tailored according to behavior change theory and included three contacts. Self-reported number of sick days in the past 6 months was assessed at all time-points. A zero-inflated negative binomial latent growth model adjusted for socio-demographics, substance use related variables and medical department was calculated. In comparison to AO, PE (OR = 2.18, p = 0.047) and CO (OR = 2.08, p = 0.047) resulted in statistically significant increased odds of reporting no sick days 24 months later. Differences between PE and CO, and concerning sick days when any reported, were non-significant. This study provides evidence for the long-term efficacy of BAIs concerning health, and concerning sick days in particular. BAIs have the potential to reduce the occurrence of sick days over 2 years, independent of whether they are delivered through in-person counseling or computer-generated written feedback.",2020,"In comparison to AO, PE (OR = 2.18, p = 0.047) and CO (OR = 2.08, p = 0.047) resulted in statistically significant increased odds of reporting no sick days 24 months later.","['960 patients (18-64\u202fyears) with at-risk alcohol use identified through systematic screening on 13 hospital wards', 'general hospital patients two years after brief', 'Patients with particularly severe alcohol problems', 'general hospital patients over two years']","['BAIs', 'alcohol interventions (BAIs', 'person counseling (PE) or computer-generated written feedback (CO', 'alcohol intervention']",['CO'],"[{'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",960.0,0.0902359,"In comparison to AO, PE (OR = 2.18, p = 0.047) and CO (OR = 2.08, p = 0.047) resulted in statistically significant increased odds of reporting no sick days 24 months later.","[{'ForeName': 'Jennis', 'Initials': 'J', 'LastName': 'Freyer-Adam', 'Affiliation': 'Institute for Medical Psychology, University Medicine Greifswald, Greifswald, Germany; German Center for Cardiovascular Research, Site Greifswald, Greifswald, Germany. Electronic address: Jennis.Freyer-Adam@med.uni-greifswald.de.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'German Center for Cardiovascular Research, Site Greifswald, Greifswald, Germany; Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany; Institute and Policlinic of Occupational and Social Medicine, Faculty of Medicine, Technische Universität Dresden, Germany.'}, {'ForeName': 'Gallus', 'Initials': 'G', 'LastName': 'Bischof', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'John', 'Affiliation': 'German Center for Cardiovascular Research, Site Greifswald, Greifswald, Germany; Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Gaertner', 'Affiliation': 'Department of Epidemiology and Health Monitoring, Robert Koch Institute Berlin, Berlin, Germany.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106106']
119,32371183,Optimization of CT windowing for diagnosing invasiveness of adenocarcinoma presenting as sub-solid nodules.,"PURPOSE
To evaluate the optimal window setting to diagnose the invasiveness of lung adenocarcinoma in sub-solid nodules (SSNs).
METHODS
We retrospectively included 437 SSNs and randomly divided them 3:1 into a training group (327) and a testing group (110). The presence of a solid component was regarded as indicator of invasiveness. At fixed window level (WL) of 35 Hounsfield Units (HU), two readers adjusted the window width (WW) in the training group and recorded once a solid component appeared or disappeared on CT images acquired at 120 kVp. The optimal WW cut-off value to differentiate between invasive and pre-invasive lesions, based on the receiver operating characteristic (ROC) curve, was defined as ""core"" WW. The diagnostic performances of the mediastinal window setting (WW/WL, 350/35 HU) and core window setting were then compared in the testing group.
RESULTS
Of the 437 SSNs, 88 were pre-invasive [17 atypical adenomatous hyperplasia (AAH) and 71 adenocarcinoma in situ (AIS)], 349 were invasive [233 minimally invasive adenocarcinoma (MIA), 116 invasive adenocarcinoma (IA)]. In training group, the core WW of 1175 HU was the optimal cut-off to detect solid components of SSNs (AUC:0.79). In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
CONCLUSION
At 120 kVp, core window setting (WW/WL, 1175/35 HU) outperformed the traditional mediastinal window setting to diagnose the invasiveness of SSNs.",2020,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","['lung adenocarcinoma in sub-solid nodules (SSNs', 'Of the 437 SSNs, 88 were pre-invasive [17 atypical adenomatous hyperplasia (AAH) and 71 adenocarcinoma in situ (AIS', '437 SSNs', ' 349 were invasive [233 minimally invasive adenocarcinoma (MIA), 116 invasive adenocarcinoma (IA']",['CT'],"['sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness']","[{'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0334001', 'cui_str': 'Atypical glandular hyperplasia'}, {'cui': 'C0334000', 'cui_str': 'Glandular hyperplasia'}, {'cui': 'C0334276', 'cui_str': 'Adenocarcinoma in situ'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1301821', 'cui_str': 'Social security number'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}]",233.0,0.0224966,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","[{'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China; University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.""}, {'ForeName': 'Shuxuan', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Marjolein A', 'Initials': 'MA', 'LastName': 'Heuvelmans', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands; Medisch Spectrum Twente, Department of Pulmonology, Enschede, the Netherlands.'}, {'ForeName': 'Daiwei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Yingru', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands.'}, {'ForeName': 'Monique D', 'Initials': 'MD', 'LastName': 'Dorrius', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'Institute for Diagnostic Accuracy (iDNA) BV, Groningen, the Netherlands; University of Groningen, Faculty of Medical Sciences, Groningen, the Netherlands.'}, {'ForeName': 'Geertruida H', 'Initials': 'GH', 'LastName': 'de Bock', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Vliegenthart', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Zhaoxiang', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China. Electronic address: yezhaoxiang@163.com.""}]",European journal of radiology,['10.1016/j.ejrad.2020.108981']
120,32371199,Clinical assessment of AF pattern is poorly correlated with AF burden and post ablation outcomes: A CIRCA-DOSE sub-study.,"BACKGROUND
Contemporary guidelines recommend that atrial fibrillation (AF) be classified into paroxysmal and persistent AF based on clinical assessment, with these categorizations forming the basis of therapeutic recommendations. While pragmatic, clinical assessment may introduce misclassification errors, which may impact treatment decisions. We sought to determine the relationship between AF classification, baseline AF burden, and post-ablation arrhythmia outcomes.
DESIGN
The current study is a sub-analysis of a prospective, parallel-group, multicenter, single-blinded randomized clinical trial. All 346 patients enrolled in CIRCA-DOSE received an implantable cardiac monitor a median of 72 days prior to ablation. AF was classified as low burden paroxysmal, high burden paroxysmal, or persistent based on clinical assessment prior to device implantation. Prior to ablation patients were re-classified using the same definitions based on device monitoring data. Correlation between classifications, AF burden, and post-ablation arrhythmia outcomes were assessed.
RESULTS
There was poor agreement between clinical and device-based AF classification (Cohen's kappa: 0.192). AF classification derived from pre-ablation continuous monitoring reflected baseline and post-ablation AF burden with greater accuracy and with less overlap between the AF classes (P < 0.01 for all categorical comparisons). Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
CONCLUSIONS
Classification of AF pattern based on pre-ablation continuous cardiac rhythm monitoring better predicted AF burden and freedom from recurrent AF post ablation. Despite the use of standardized definitions, classification of AF based on clinical assessment did not predict baseline AF burden, post ablation AF burden, or freedom from recurrent AF post ablation.
TRIAL REGISTRATION
ClinicalTrials.govNCT01913522.",2020,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
",['346 patients enrolled in'],"['implantable cardiac monitor', 'CIRCA-DOSE']","['AF burden, and post-ablation arrhythmia outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3879681', 'cui_str': 'Implantable cardiac monitor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",346.0,0.0501133,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada; Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada. Electronic address: Jason.andrade@vch.ca.'}, {'ForeName': 'Robert R J', 'Initials': 'RRJ', 'LastName': 'Yao', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Hawkins', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Rizkallah', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Umjeet', 'Initials': 'U', 'LastName': 'Jolly', 'Affiliation': ""St. Mary's Hospital, Kitchener, Canada.""}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'St. Boniface Hospital, Winnipeg, Canada.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Raymond', 'Affiliation': 'Centre Hospitalier Universitaire de Montreal, Université de Montréal, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKinney', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Steinberg', 'Affiliation': 'Department of Medicine, Université Laval, Quebec, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ha', 'Affiliation': 'Toronto General Hospital, University of Toronto, Toront006F, Canada.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Luong', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Glover', 'Affiliation': 'Sunnybrook Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.008']
121,32491923,Administration of rectal cytotec versus rectal buscopan before hysteroscopy.,"Introduction: Our objective was to compare the effect of rectal misoprostol (Cytotec) versus rectal hyoscine-n-butyl bromide (Buscopan) on patients undergoing hysteroscopy. We hypothesised that HBB may have a role in cervical priming. Material and methods: This trial was conducted at Bezmialem Vakif University Hospital. Women of reproductive age between 18-50 years who were scheduled for operative hysteroscopy indicated by type 1 submucous myoma or endometrial polyps were recruited for the study. Ninety patients were divided randomly into three groups. Group 1 received placebo treatment. Group 2 received rectal 200 mcg misoprostol and Group 3 received rectal 20 mg hyoscine-n-butyl bromide two hours before the procedure. Procedures were performed using a bipolar 26 F (9 mm) continuous-flow rigid resectoscope with a 30° lens. The outcome measures included cervical dilation width and time, ease of cervical dilation, procedure time and operative complications. Postoperative self-rated pain was assessed one hour after the procedure. Results: Thirteen patients (43. 3%) in the placebo treatment group, 11 patients (36.7%) in the misoprostol group and four patients (13.3%) in the hyoscine-n-butyl bromide group needed analgesics postoperatively ( p = .02). The mean duration of cervical dilation time was longest in Group 1 and shortest in Group 3, however this difference did not reach statistical significance ( p =.11). There was no difference with regard to other studied parameters. Summary: HBB reduced the need for pain medication compared to placebo. Larger studies are needed to further investigate the role of HBB in facilitating pre-operative cervical priming.",2020,"The mean duration of cervical dilation time was longest in Group 1 and shortest in Group 3, however this difference did not reach statistical significance ( p =.11).","['Bezmialem Vakif University Hospital', 'patients undergoing hysteroscopy', 'Women of reproductive age between 18-50\u2009years who were scheduled for operative hysteroscopy indicated by type 1 submucous myoma or endometrial polyps were recruited for the study', 'Ninety patients']","['bipolar 26\u2009F (9\u2009mm) continuous-flow rigid resectoscope with a 30° lens', 'rectal 20\u2009mg hyoscine-n-butyl bromide', 'hyoscine', 'misoprostol', 'rectal misoprostol (Cytotec) versus rectal hyoscine-n-butyl bromide (Buscopan', 'rectal 200\u2009mcg misoprostol', 'rectal cytotec versus rectal buscopan', 'placebo']","['mean duration of cervical dilation time', 'Postoperative self-rated pain', 'cervical dilation width and time, ease of cervical dilation, procedure time and operative complications', 'pain medication']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0156369', 'cui_str': 'Polyp of corpus uteri'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0626372', 'cui_str': 'butyl bromide'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0701019', 'cui_str': 'Buscopan'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0591321', 'cui_str': 'Cytotec'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",90.0,0.156477,"The mean duration of cervical dilation time was longest in Group 1 and shortest in Group 3, however this difference did not reach statistical significance ( p =.11).","[{'ForeName': 'Ayse Filiz', 'Initials': 'AF', 'LastName': 'Gokmen Karasu', 'Affiliation': 'Department of Obstetrics and Gynecology, Bezmialem Vakif University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Aydin', 'Affiliation': 'Department of Obstetrics and Gynecology, Bezmialem Vakif University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Ates', 'Affiliation': 'Department of Obstetrics and Gynecology, Bezmialem Vakif University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Takmaz', 'Affiliation': 'Department of Obstetrics and Gynecology, Bezmialem Vakif University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Comba', 'Affiliation': 'Department of Gynecologic Oncology, Bakirkoy Sadi Konuk Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}]",Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy,['10.1080/13645706.2020.1748059']
122,32375722,Is body image a predictor of women's depression and anxiety in postmenopausal women?,"BACKGROUND
Women in perimenopausal and postmenopausal period are at increased risk of depression and anxiety. Physiologic changes in menopause can change body's appearance and function that may disturb body and then lead to anxiety and depression. This study aims to assess the relationship between body image with anxiety and depression among postmenopausal women.
METHODS
This descriptive study was performed on 307 women attending to the health centers in Tehran- Iran. Sampling was performed by a multi-staged randomized method. Data were collected by using Beck Depression questionnaire, Spielberger Anxiety Questionnaire, Fisher Body Image Questionnaire and Socio-demographic questionnaires. Data were analyzed by SPSS 21 and using t-test, Pearson and Spearman correlation tests and multiple linear regression methods.
RESULTS
The average age of the participants was 55.19 ± 4.034 years. Mean scores for body image, anxiety and depression were 163.26 ± 20.38, 12.00 ± 7.71 and 42.70 ± 8.40 respectively. Fifty five percent of women had mild to severe depression and 83.7% of them had mild to severe anxiety. Total score and all domains of body image had a negative correlation with depression and anxiety scores (P < 0.001). Multiple linear correlation showed that body image is a predictor for depression and anxiety (P < 0.001).
CONCLUSIONS
Body image of women can be effective on occurrence of depression and anxiety in menopause. Therefore, women's health policies should consider body image to control cognitive problems including depression and anxiety in menopause.",2020,Total score and all domains of body image had a negative correlation with depression and anxiety scores (P < 0.001).,"['postmenopausal women', ""women's depression and anxiety in postmenopausal women"", '307 women attending to the health centers in Tehran- Iran']",[],"['Total score', 'severe depression', 'severe anxiety', 'Mean scores for body image, anxiety and depression', 'depression and anxiety scores', 'Beck Depression questionnaire, Spielberger Anxiety Questionnaire, Fisher Body Image Questionnaire and Socio-demographic questionnaires', 'depression and anxiety']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",307.0,0.0537412,Total score and all domains of body image had a negative correlation with depression and anxiety scores (P < 0.001).,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Simbar', 'Affiliation': 'Midwifery and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Nazarpour', 'Affiliation': 'Department of Midwifery, Chalous Branch, Islamic Azad University, Chalous, Iran. sn_9547@yahoo.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alavi Majd', 'Affiliation': 'Department of Biostatistics, School of Paramedicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Dodel Andarvar', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Jafari Torkamani', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Alsadat Rahnemaei', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC psychiatry,['10.1186/s12888-020-02617-w']
123,32383680,"Efficacy and Impact of Digital HIV Care Navigation in Young People Living With HIV in San Francisco, California: Prospective Study.","BACKGROUND
Young people are disproportionately impacted by HIV infection and exhibit poor HIV care continuum outcomes. Mobile health (mHealth) interventions are promising approaches to meet the unique needs of young people living with HIV. Youth-focused interventions are needed to improve HIV care continuum outcomes.
OBJECTIVE
This study assessed the preliminary efficacy and impact of a digital HIV care navigation intervention among young people living with HIV in San Francisco. Health electronic navigation (eNavigation or eNav) is a 6-month, text message-based, digital HIV care navigation intervention, in which young people living with HIV are connected to their own HIV care navigator through text messaging to improve engagement in HIV primary care.
METHODS
This study had a single-arm, prospective, pre-post design. The analysis included 120 young men who have sex with men or transwomen living with HIV aged between 18 and 34 years. We analyzed self-reported sociobehavioral information pre- and postintervention at baseline and 6 months, which was collected using computer-assisted self-interviewing surveys. We characterized the sample and built generalized estimating equation (GEE) models to assess differences in HIV care continuum outcomes at baseline and 6 months.
RESULTS
The characteristics according to the intervention completion status were not different from those of the overall sample. The mean age of the participants was 27.75 years (SD 4.07). Most participants (103/120, 85.8%) identified as men, and the sample was racially/ethnically diverse. At baseline, majority (99/120, 82.5%) of the participants had recently received primary HIV care, yet this was more likely in those who completed the intervention than in those who did not (54/60, 90% vs 45/60, 75%; χ 2 1 =4.68, P=.03). More than half of the sample reported taking antiretroviral therapy (92/120, 76.7%) and having an undetectable viral load (65/120, 54.2%). The 6-month follow-up surveys were completed by 73.3% (88/120) of participants, and these participants were not characteristically different from the overall sample at baseline. GEE models indicated that participants had increased odds of viral suppression at 6 months as compared with baseline. No relevant additive or multiplicative interactions were noted on comparing outcome effects over time according to intervention completion.
CONCLUSIONS
Digital HIV care navigation fills a critical gap in public health and HIV care systems, making these systems more responsive and accountable to the needs of the most vulnerable individuals. Our intervention bridges the time between primary care visits with interactive, tailored, personalized, and peer-delivered social support; information; and motivational interviewing to scaffold behavioral change. This study is part of the next wave of system-informed mHealth intervention research that will offer potentially disruptive solutions to traditional in-person delivered interventions and improve the health of the most vulnerable individuals.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/16406.",2020,Mobile health (mHealth) interventions are promising approaches to meet the unique needs of young people living with HIV.,"['young people living with HIV in San Francisco', 'young people living with HIV', 'Young People Living With HIV in San Francisco, California', '120 young men who have sex with men or transwomen living with HIV aged between 18 and 34 years', 'Most participants (103/120, 85.8%) identified as men, and the sample was racially/ethnically diverse']","['Health electronic navigation (eNavigation or eNav', 'Digital HIV Care Navigation', 'Mobile health (mHealth) interventions', 'digital HIV care navigation intervention']",['viral suppression'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",120.0,0.0756441,Mobile health (mHealth) interventions are promising approaches to meet the unique needs of young people living with HIV.,"[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Arayasirikul', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Dillon', 'Initials': 'D', 'LastName': 'Trujillo', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Victory', 'Initials': 'V', 'LastName': 'Le', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Wilson', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/18597']
124,32383682,Combining Web-Based Attentional Bias Modification and Approach Bias Modification as a Self-Help Smoking Intervention for Adult Smokers Seeking Online Help: Double-Blind Randomized Controlled Trial.,"BACKGROUND
Automatically activated cognitive motivational processes such as the tendency to attend to or approach smoking-related stimuli (ie, attentional and approach bias) have been related to smoking behaviors. Therefore, these cognitive biases are thought to play a role in maintaining smoking behaviors. Cognitive biases can be modified with cognitive bias modification (CBM), which holds promise as an easy-access and low-cost online intervention. However, little is known about the effectiveness of online interventions combining two varieties of CBM. Targeting multiple cognitive biases may improve treatment outcomes because these biases have been shown to be relatively independent.
OBJECTIVE
This study aimed to test the individual and combined effects of two web-based CBM varieties-attentional bias modification (AtBM) and approach bias modification (ApBM)-in a double-blind randomized controlled trial (RCT) with a 2 (AtBM: active versus sham) × 2 (ApBM: active versus sham) factorial design.
METHODS
A total of 504 adult smokers seeking online help to quit smoking were randomly assigned to 1 of 4 experimental conditions to receive 11 fully automated CBM training sessions. To increase participants' intrinsic motivation to change their smoking behaviors, all participants first received brief, automated, tailored feedback. The primary outcome was point prevalence abstinence during the study period. Secondary outcomes included daily cigarette use and attentional and approach bias. All outcomes were repeatedly self-assessed online from baseline to the 3-month follow-up. For the examination of training effects on outcome changes, an intention-to-treat analysis with a multilevel modeling (MLM) approach was adopted.
RESULTS
Only 10.7% (54/504) of the participants completed all 11 training sessions, and 8.3% (42/504) of the participants reached the 3-month follow-up assessment. MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001).
CONCLUSIONS
This RCT provides no support for the effectiveness of combining AtBM and ApBM in a self-help web-based smoking cessation intervention. However, this study had a very high dropout rate and a very low frequency of training usage, indicating an overall low acceptability of the intervention, which precludes any definite conclusion on its efficacy. We discuss how this study can inform future designs and settings of online CBM interventions.
TRIAL REGISTRATION
Netherlands Trial Register NTR4678; https://www.trialregister.nl/trial/4678.",2020,"MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001).
","['504 adult smokers seeking online help to quit smoking', 'Adult Smokers Seeking Online Help']","['two web-based CBM varieties-attentional bias modification (AtBM) and approach bias modification (ApBM)-in', 'MLM', '2 (AtBM: active versus sham', '11 fully automated CBM training sessions', 'Combining Web-Based Attentional Bias Modification and Approach Bias Modification as a Self-Help Smoking Intervention']","['daily cigarette use and attentional and approach bias', 'prevalence abstinence', 'prevalence abstinence rates', 'AtBM or ApBM', 'changes in daily cigarette use', 'attentional bias']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",504.0,0.312757,"MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001).
","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Larsen', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marilisa', 'Initials': 'M', 'LastName': 'Boffo', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus University Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Raoul P P P', 'Initials': 'RPPP', 'LastName': 'Grasman', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pronk', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Joeri B G', 'Initials': 'JBG', 'LastName': 'van Wijngaarden', 'Affiliation': 'Max Planck Institute for Brain Research, Frankfurt, Germany.'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}]",JMIR mental health,['10.2196/16342']
125,32379992,"Reduction of Halitosis by a Tablet Containing Weissella cibaria CMU: A Randomized, Double-Blind, Placebo-Controlled Study.","Halitosis is referred to as an unpleasant odor coming from the mouth. Recently, probiotics have been studied as an alternative prevention for halitosis. The aim of this study was to evaluate the effects of probiotic bacterium Weissella cibaria Chonnam Medical University (CMU)-containing tablets (1 × 10 8 colony forming units [CFU]/g) on oral malodor. The randomized, double-blind, placebo-controlled trial was conducted in 92 healthy adults (20-39 years of age) with bad breath. All subjects were randomly assigned to a test (probiotic, n = 49) or control (placebo, n = 43) group after dental scaling and root planing. The tablets were taken once daily for 8 weeks. Measurements included an organoleptic test (OLT), volatile sulfur compounds (VSC), bad breath improvement (BBI) scores, and the oral colonization of W. cibaria CMU. This study also assessed safety variables of adverse reactions, vital signs, and the findings of hematology and blood chemistry. Most of the variables were measured at baseline, 4, and 8 weeks. Safety-related variables were measured at baseline and 8 weeks. At week 4, a significant decrease in OLT and VSC results was observed in the test group while BBI scores were significantly reduced at week 8 ( P < .05). Statistically significant intergroup differences were observed for changes in W. cibaria number at weeks 4 and 8. No safety issues were encountered in either group. These results indicate that W. cibaria CMU tablets could be a safe and useful oral care product for controlling bad breath.",2020,"At week 4, a significant decrease in OLT and VSC results was observed in the test group while BBI scores were significantly reduced at week 8 ( P < .05).","['92 healthy adults (20-39 years of age) with bad breath', 'Weissella cibaria Chonnam Medical University (CMU)-containing tablets (1\u2009×']","['probiotic bacterium', 'test (probiotic, n \u2009=\u200949) or control (placebo, n \u2009=\u200943) group after dental scaling and root planing', 'Placebo', 'placebo']","['OLT and VSC results', 'BBI scores', 'organoleptic test (OLT), volatile sulfur compounds (VSC), bad breath improvement (BBI) scores, and the oral colonization of W. cibaria CMU']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C1066567', 'cui_str': 'Weissella cibaria'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0038776', 'cui_str': 'Sulfur compound'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",92.0,0.428105,"At week 4, a significant decrease in OLT and VSC results was observed in the test group while BBI scores were significantly reduced at week 8 ( P < .05).","[{'ForeName': 'Dong-Suk', 'Initials': 'DS', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, Kangwon National University, Chuncheon, Korea.'}, {'ForeName': 'Seung-Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, Kangwon National University, Chuncheon, Korea.'}, {'ForeName': 'Myoungsuk', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'School of Nursing, Kangwon National University, Chuncheon, Korea.'}, {'ForeName': 'Seoul-Hee', 'Initials': 'SH', 'LastName': 'Nam', 'Affiliation': 'Department of Dental Hygiene, School of Health Science, Kangwon National University, Samcheok, Korea.'}, {'ForeName': 'Mi-Sun', 'Initials': 'MS', 'LastName': 'Kang', 'Affiliation': 'R&D Department, Research Institute, OraPharm, Inc., Seoul, Korea.'}]",Journal of medicinal food,['10.1089/jmf.2019.4603']
126,32380001,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30243-7.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30243-7'],[],[],[],[],,0.0193234,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30368-6']
127,32380119,Exposure to harmful and potentially harmful constituents decreased in smokers switching to Carbon-Heated Tobacco Product.,"BACKGROUND
""Heat-not-burn"" tobacco products are designed to heat processed tobacco instead of combusting it, thus significantly reducing the formation of harmful and potentially harmful constituents (HPHCs) found in cigarette smoke, and ultimately reducing the risk of smoking-related diseases. The Carbon-Heated Tobacco Product (CHTP), a heat-not-burn tobacco product similar in appearance and use ritual to cigarettes, has been developed for smokers who would otherwise continue smoking as an alternative to cigarettes. To evaluate reduced risk of harm potential of CHTP, it is critical to quantify exposure to HPHCs and consequent biological pathway disturbances involved in disease onset in smokers who switch to CHTP.
METHODS
In this 2-arm, parallel-group study, adult healthy smokers, not willing to quit, were randomized to switch to CHTP 1.2 (n = 80) or to continue using cigarettes (n = 40) for 5 days in confinement followed by 85 days in an ambulatory setting. Endpoints included biomarkers of exposure (BoExp) to HPHCs, and to nicotine, urinary excretion of mutagenic constituents (Ames assay), CYP1A2 activity, biomarkers of effect, and safety.
RESULTS
In switchers to CHTP, BoExp were 40%-95% lower compared to smokers after 5 days of product use, with sustained reductions (36%-93%) observed on Day 90. Urine mutagenicity and CYP1A2 activity were also lower in the CHTP group. Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day 90. Favorable changes in some biomarkers of effect were observed in the CHTP group showing reductions in white blood cell count, soluble intracellular adhesion molecule-1, and 11-dehydro-thromboxane B2, respectively, indicative of reduced inflammation, endothelial dysfunction, and platelet activation.
CONCLUSIONS
Switching from cigarettes to CHTP resulted in significantly reduced exposure to HPHCs and was associated with observed improvements in some biomarkers of effect representative of pathomechanistic pathways underlying the development of smoking-related diseases.",2020,"Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day90.","['smokers who switch to CHTP', 'adult healthy smokers, not willing to quit']","['CHTP', 'Carbon-Heated Tobacco Product (CHTP']","['white blood cell count, soluble intracellular adhesion molecule-1, and 11-dehydro-thromboxane B2 respectively indicative of reduced inflammation, endothelial dysfunction, and platelet activation', 'biomarkers of exposure (BoExp) to HPHCs, and to nicotine, urinary excretion of mutagenic constituents (Ames assay), CYP1A2 activity, biomarkers of effect, and safety', 'Urine mutagenicity and CYP1A2 activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0600109', 'cui_str': 'Willing'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0044728', 'cui_str': '11-dehydro-thromboxane B2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0207509', 'cui_str': 'Cytochrome p450 CYP1A2 enzyme'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",,0.0196296,"Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day90.","[{'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Bosilkovska', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland. Electronic address: Marija.Bosilkovska@contracted.pmi.com.'}, {'ForeName': 'Cam Tuan', 'Initials': 'CT', 'LastName': 'Tran', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'de La Bourdonnaye', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Brindusa', 'Initials': 'B', 'LastName': 'Taranu', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Benzimra', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}]",Toxicology letters,['10.1016/j.toxlet.2020.04.013']
128,32380132,Is a two-step impression mandatory for complete denture fabrication on the severely resorbed mandible? A randomized trial on patient perception and denture quality.,"OBJECTIVES
To evaluate the effectiveness of CCDs produced by two impression procedures for the mandibular ridge, in patients with severe mandibular atrophy.
METHODS
Fifty-two completely edentulous patients with severely resorbed mandibles were randomly allocated into two groups according to the impression procedure of the mandibular ridge: SI - single impression (stock tray and irreversible hydrocolloid); TI - two-step impression (custom tray, border molding with compound, and polyether). Assessments of oral health related quality of life (OHRQoL, primary outcome) and denture satisfaction were performed by using validated questionnaires. Denture quality was evaluated by means of functional tests.
RESULTS
Regardless of the technique, participants reported better OHRQoL (P < 0.001) in both follow-up periods (3 and 6 months after denture delivery), and groups resulted in similar OHIP-EDENT scores in its different domains (P > 0.05). Between-group differences were insignificant for general satisfaction (3 months, P = 0.699, 6 months, P = 0.392), as well as for aspects such as esthetics, comfort, mastication, speech, and prosthesis retention (P > 0.05). Overall clinical quality of the CCDs (P = 0.383) was similar between-group, as well as in specific aspects - interocclusal distance, occlusion, articulation, retention of the maxillary denture, and stability of both maxillary and mandibular dentures (P > 0.05).
CONCLUSIONS
Mandibular CCDs based on a single impression technique showed quality levels comparable to those generated by a two-step impression, both from the patient and clinician perspective.
CLINICAL SIGNIFICANCE
A simplified impression technique which eliminates the secondary impression can provide CCDs of good clinical quality, which influences the OHRQoL, and satisfaction in the same extent they would by a two-step procedure, even for patients with severely reabsorbed mandibular ridges. (ClinicalTrials.gov: NCT02339194).",2020,"Regardless of the technique, participants reported better OHRQoL","['patients with severely reabsorbed mandibular ridges', 'patients with severe mandibular atrophy.\nMETHODS\n\n\nFifty-two completely edentulous patients with severely resorbed mandibles']","['impression procedure of the mandibular ridge: SI - single impression (stock tray and irreversible hydrocolloid); TI - two-step impression (custom tray, border molding with compound, and polyether', 'CCDs']","['patient perception and denture quality', 'oral health related quality of life (OHRQoL, primary outcome) and denture satisfaction', 'specific aspects - interocclusal distance, occlusion, articulation, retention of the maxillary denture, and stability of both maxillary and mandibular dentures', 'Overall clinical quality of the CCDs', 'quality levels', 'Denture quality', 'general satisfaction', 'OHRQoL', 'similar OHIP-EDENT scores', 'esthetics, comfort, mastication, speech, and prosthesis retention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0020266', 'cui_str': 'Hydrocolloid'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0426103', 'cui_str': 'Fetal head molding'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C3178965', 'cui_str': 'Prosthesis Retention'}]",52.0,0.0541727,"Regardless of the technique, participants reported better OHRQoL","[{'ForeName': 'Ivo S', 'Initials': 'IS', 'LastName': 'Albuquerque', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Rômulo R', 'Initials': 'RR', 'LastName': 'Regis', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil. Electronic address: romuloregis@hotmail.com.'}, {'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, 2001 McGill College Ave, Suite 500, Montreal, Quebec. Canada.'}, {'ForeName': 'Kelvin F', 'Initials': 'KF', 'LastName': 'Gurgel', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Paulo Gb', 'Initials': 'PG', 'LastName': 'Silva', 'Affiliation': 'Department of Dental Clinic, Division of Oral Pathology, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Livia M S', 'Initials': 'LMS', 'LastName': 'Pinto-Fiamengui', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Karina M', 'Initials': 'KM', 'LastName': 'Freitas-Pontes', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103356']
129,32380135,Measurement of eroded dentine tubule patency and roughness following novel dab-on or brushing abrasion.,"OBJECTIVES
To investigate the effect of dab-on or brushing of stannous-fluoride SnF2 or sodium-fluoride NaF dentifrice on eroded dentine tubule patency, surface and inter-tubular dentine roughness, using Confocal-Laser-Scanning-Microscopy (CLSM), Atomic-Force-Microscopy (AFM), Energy-Dispersive-X-ray-Spectroscopy (EDX), Scanning-Electron-Microscopy (SEM) and Contact-Profilometry (CP).
METHODS
75-polished human dentine samples were prepared and eroded in agitated 6% citric acid to expose patent tubules and 'initiate' DH. Samples were randomly allocated into 5 intervention groups; artificial saliva control (1); electric tooth-brushing with NaF (2) or SnF2 (3), and dab-on application of NaF (4) or SnF2 (5). Samples underwent three cycles of intervention followed by further acid challenge. Patent tubules, likely to cause DH clinically, were measured using validated biocomputational methods with CLSM images of dentine surfaces taken baseline and post-intervention. Randomised samples (n = 15, 20 %) were investigated using AFM, EDX and SEM to study surface and sub-surface tubular occlusion. Dentine surface and inter-tubular roughness were measured using CP and AFM respectively.
RESULTS
At baseline, mean tubule patency in all samples was 216 (SD 58) with no significant inter-group differences. Post-intervention, the mean patency was 220 (40) and 208 (35) in groups 1 and 2 respectively (p ≥ 0.06), but decreased to 62 (41), 62 (21) and 63 (19) in groups 3, 4 and 5 respectively (p < 0.0001). Patency was confirmed using AFM, SEM and EDX. SnF2 interventions created greater sub-surface occlusion (p < 0.01), and increased CP surface roughness (p = 0.015). Significant negative correlation (-0.6) existed between CP surface roughness and tubule patency (p = 0.009).
CONCLUSIONS
Dab-on with NaF and SnF2 or brushing with SnF2 reduces DH in eroded dentine with ongoing acid challenges. Contacting surface roughness measures indicate risk of DH.
CLINICAL SIGNIFICANCE
Dab-on is a convenient supplementary method of dentifrice application to reduce DH; it beneficially avoids brushing post-erosion or overzealous brushing, enables re-establishment of an appropriate brushing regime post-DH and supports oral health. Significant modes of action of SnF2 in reducing DH are revealed. Finally, CP roughness measures provide indication of dentine lesions that may cause DH clinically.",2020,"SnF2 interventions created greater sub-surface occlusion (p < 0.01), and CP surface roughness (p = 0.015).",['75-polished human dentine samples were prepared and eroded in agitated 6'],"[""citric acid to expose patent tubules and 'initiate' DH"", 'NaF dentifrice', 'stannous-fluoride SnF2 or sodium-fluoride', 'artificial saliva control (1); electric tooth-brushing with NaF (2) or SnF2 (3), and dab-on application of NaF (4) or SnF2 (5']","['CP surface roughness and tubule patency', 'mean patency', 'eroded dentine tubule patency, surface and inter-tubular dentine roughness, using Confocal-Laser-Scanning-Microscopy (CLSM), Atomic-Force-Microscopy (AFM), Energy-Dispersive-X-ray-Spectroscopy (EDX), Scanning-Electron-Microscopy (SEM) and Contact-Profilometry (CP', 'sub-surface occlusion', 'mean tubule patency', 'CP surface roughness', 'Dentine surface and inter-tubular roughness']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}]","[{'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0012411', 'cui_str': '4-dimethylaminoazobenzene'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}, {'cui': 'C0242849', 'cui_str': 'Atomic Force Microscopy'}, {'cui': 'C2699997', 'cui_str': 'Energy Dispersive X-Ray Fluorescence Spectroscopy'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",,0.0311758,"SnF2 interventions created greater sub-surface occlusion (p < 0.01), and CP surface roughness (p = 0.015).","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Olley', 'Affiliation': 'Cardiff University, School of Dentistry, University Hospital Wales, Heath Park, Cardiff CF14 4XY, UK; Faculty of Dentistry, Oral and Craniofacial Sciences, Kings College London, London, UK. Electronic address: olleyr1@cardiff.ac.uk.'}, {'ForeName': 'Basim M', 'Initials': 'BM', 'LastName': 'Mohsen', 'Affiliation': 'Dental School, University of Dundee, Dundee, UK. Electronic address: bmmohsen1@sheffield.ac.uk.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Alhaij', 'Affiliation': 'Dental School, University of Dundee, Dundee, UK. Electronic address: s.alhaij@dundee.ac.uk.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Appleton', 'Affiliation': 'School of Life Sciences, University of Dundee, Dundee, UK. Electronic address: P.L.Appleton@dundee.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103358']
130,32380138,Reduced tactile acuity in chronic low back pain is linked with structural neuroplasticity in primary somatosensory cortex and is modulated by acupuncture therapy.,"Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N = 50) and a large sample of cLBP patients (N = 102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P = 0.01) over the low back, but not finger (P = 0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P < 0.05). GMV in cLBP correlated with greater 2PDT-back scores (ρ = 0.27, P = 0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (ρ = 0.52, P = 0.03) and increased S1-back adjacent white matter FA (ρ = -0.56, P = 0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.",2020,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","['patients suffering from chronic Low Back Pain (cLBP', 'healthy control adults (HC, N=50) and a large sample of cLBP patients (N=102) with']","['acupuncture', 'structural brain imaging (T1-weighted MRI for Voxel Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT', 'verum acupuncture', 'sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control']","['tactile acuity', 'S1-back adjacent white matter FA', '2PDT-back scores', 'Fractional Anisotropy (FA', 'tactile acuity over the back was improved (reduced 2PDT', 'reduced S1-back GMV', 'reduced acuity', 'Gray Matter Volume (GMV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",102.0,0.102659,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","[{'ForeName': 'Hyungjun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ishtiaq', 'Initials': 'I', 'LastName': 'Mawla', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jeungchan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Marco L', 'Initials': 'ML', 'LastName': 'Loggia', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies & Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ""Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA. Electronic address: vitaly@mgh.harvard.edu.""}]",NeuroImage,['10.1016/j.neuroimage.2020.116899']
131,32380239,Effects of Partial Sleep Deprivation on Braking Response of Drivers in Hazard Scenarios.,"This study aimed at modeling the Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD). Fifty male participants drove the driving simulator in three experimental conditions: two test sessions and a baseline. The two test sessions were conducted after one and two nights of PSD (sleep = 4.25 ± 0.5 h), respectively. Sleep reduction was recorded using a wrist-worn Actiwatch. The baseline session was conducted after full rest (7-8 h sleep/day for a week). The order of test sessions and baseline was randomized. Each test included two hazard events: 1) pedestrians crossing a road and 2) parked vehicles merging into a roadway. Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings were also recorded during each drive. Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events. The models were chosen with clustered heterogeneity to account for intra-group heterogeneity due to repeated measures across tests. In the case of pedestrians crossing event, RT increased by 10% in the first test session and no significant effect observed on RT in the second test session. The overall TBT reduced by 25% and 28% during the first and second PSD sessions, respectively. In the case of vehicle merging event, both response time and total braking time delayed by 44% and 17% respectively after PSD. Other factors such as age, experience, work-rest hours, KSS and SSQ rating, often exercising, approaching speed and braking force were also found significant in the analysis. The parametric AFT approach adopted in this study showed the change in 'response time' and 'total braking time' concerning the type of hazard scenario and partial sleep-deprivation.",2020,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"['Fifty male participants', 'Drivers in Hazard Scenarios']",['Partial Sleep Deprivation'],"['Sleep reduction', 'response time and total braking time delayed', 'pedestrians crossing a road and 2) parked vehicles merging into a roadway', 'Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings', 'overall TBT', 'Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",50.0,0.023591,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Mahajan', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India.'}, {'ForeName': 'Nagendra R', 'Initials': 'NR', 'LastName': 'Velaga', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India. Electronic address: n.r.velaga@iitb.ac.in.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105545']
132,32380260,Methodological and reporting issues in a randomised controlled trial: Comment on de la Fuente et al (2020).,,2020,,[],[],[],[],[],[],,0.0693986,,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast BT9 7BL, United Kingdom. Electronic address: p.ohalloran@qub.ac.uk.""}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103585']
133,32393092,Laughter yoga reduces the cortisol response to acute stress in healthy individuals.,"Stress is one of the foremost contributors to the development of psychiatric diseases. Since the prevalence of stress-related complaints is increasing, we are in need for affordable and effective treatment alternatives. Laughter yoga (LY), a popular method encouraging participants to simulate laughter and participate in yogic breathing exercises, is hypothesized to buffer negative effects of stress. Although widely practiced, empirical evidence for beneficial effects of LY is scarce. We investigated the acute effects of a single 30-min LY session on the autonomic, endocrine and psychological response to a standardized psychosocial stressor. Thirty-five healthy subjects (51% female) were randomly assigned to experience either a LY ( n = 11), a relaxation breathing ( n = 12) or a (non-intervention) control ( n = 12) session prior to their exposure to the Trier Social Stress Test for Groups (TSST-G). Salivary cortisol, salivary alpha amylase, and subjective stress were assessed repeatedly throughout the experiment. We expected that LY and relaxation breathing group each show a downregulation of stress response indices compared to the control group. Further, we expected that LY has beneficial effects compared to relaxation breathing. The groups did not differ in salivary cortisol, alpha amylase or subjective stress reactivity during the 30-min intervention. However, in response to the TSST-G, the LY, but neither the relaxation breathing, nor the control condition, showed an attenuated cortisol stress response. These findings highlight the potential of LY to buffer the endocrine stress response. Therefore, LY could be used as a cheap and easily-to-implement add-on to more traditional stress interventions.LAY SUMMARYIn recent years, more and more people have reported to feel stressed. Although our body is well equipped to deal with acute stress, chronic stress can tire our system and contribute to illness in the long run. Therefore, we need affordable and effective measures to reduce stress. In this study we have investigated whether a single laughter yoga session can help us to deal with acute stress. Although laughter yoga did not change how stressful a situation was perceived, it reduced the amount of stress hormones that were released in response to the situation. As such, laughter yoga might be a cheap and easily-to-implement add-on to more traditional stress reduction interventions.",2020,"Although laughter yoga did not change how stressful a situation was perceived, it reduced the amount of stress hormones that were released in response to the situation.","['Thirty-five healthy subjects (51% female', 'healthy individuals']","['Laughter yoga (LY', 'single laughter yoga session', 'Laughter Yoga', 'relaxation breathing ( n \u2009=\u200912) or a (non-intervention) control ( n \u2009=\u200912) session prior to their exposure to the Trier Social Stress Test for Groups (TSST-G']","['cortisol stress response', 'Salivary cortisol, salivary alpha amylase, and subjective stress', 'cortisol response', 'salivary cortisol, alpha amylase or subjective stress reactivity', 'autonomic, endocrine and psychological response']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4045984', 'cui_str': 'Laughter Yoga'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",35.0,0.0113006,"Although laughter yoga did not change how stressful a situation was perceived, it reduced the amount of stress hormones that were released in response to the situation.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wirz', 'Affiliation': 'Department of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Dickinson', 'Affiliation': ""Centre de recherche de l'Institut universitaire de gériatrie de Montréal, Canada.""}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Department of Psychology, University of Constance, Constance, Germany.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2020.1766018']
134,32393099,Budesonide vs Saline Nasal Irrigation in Allergic Rhinitis: A Randomized Placebo-Controlled Trial.,"OBJECTIVES
Budesonide nasal irrigation is currently widely used in the treatment of chronic sinusitis typically following endoscopic sinus surgery to improve inflammatory control. Its application in treatment of allergic rhinitis has not been previously studied. This study assesses the subjective and clinical response to budesonide buffered hypertonic saline nasal irrigation and hypertonic saline nasal irrigation in patients with allergic rhinitis.
STUDY DESIGN
This is a prospective, single-center, double-blind, randomized placebo-controlled trial.
SETTING
Tertiary care hospital.
SUBJECTS AND METHODS
Fifty-two patients diagnosed with allergic rhinitis were randomized into 2 groups to receive either buffered hypertonic saline nasal irrigation with a placebo respule or buffered hypertonic saline nasal irrigation with a budesonide respule. Patients were assessed at baseline and 4 weeks subjectively using the Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire and visual analog scale (VAS). Clinical assessment was done using the modified Lund-Kennedy score.
RESULTS
The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P < .001). The budesonide irrigation group was found to have significantly better improvement than the saline nasal irrigation group with the SNOT-22 scores ( P = .012) and VAS scores ( P = .007). However, the difference in the clinical response between the 2 groups was not significant ( P = .268).
CONCLUSION
This study adds evidence to the use of saline nasal irrigation in allergic rhinitis but also demonstrates efficacy of the addition of budesonide to irrigations. Budesonide nasal irrigation thus appears to be a viable treatment option for allergic rhinitis.",2020,"The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P < .001).","['Allergic Rhinitis', 'Fifty-two patients diagnosed with allergic rhinitis', 'Tertiary care hospital', 'patients with allergic rhinitis']","['Placebo', 'budesonide irrigation', 'budesonide buffered hypertonic saline nasal irrigation and hypertonic saline nasal irrigation', 'hypertonic saline nasal irrigation with a placebo respule or buffered hypertonic saline nasal irrigation with a budesonide respule', 'Budesonide', 'Saline Nasal Irrigation', 'saline nasal irrigation', 'Budesonide nasal irrigation', 'placebo']","['Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire and visual analog scale (VAS', 'clinical response', 'average SNOT-22, VAS, and modified Lund-Kennedy scores', 'SNOT-22 scores', 'VAS scores']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0360546', 'cui_str': 'Budesonide-containing product in nasal dose form'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",52.0,0.0682754,"The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P < .001).","[{'ForeName': 'Nikitha', 'Initials': 'N', 'LastName': 'Periasamy', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Kailesh', 'Initials': 'K', 'LastName': 'Pujary', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Ajay M', 'Initials': 'AM', 'LastName': 'Bhandarkar', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Naveen D', 'Initials': 'ND', 'LastName': 'Bhandarkar', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.'}, {'ForeName': 'Balakrishnan', 'Initials': 'B', 'LastName': 'Ramaswamy', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820919363']
135,32394350,Carboplatin plus taxanes are non-inferior to epirubicin plus cyclophosphamide followed by taxanes as adjuvant chemotherapy for early triple-negative breast cancer.,"PURPOSE
Platinum plays an important role in the treatment of triple-negative breast cancer (TNBC) in neoadjuvant and metastatic settings. However, its role in an adjuvant setting remains unclear.
METHODS
In this non-inferior randomized phase 2 trial, we randomly assigned 308 chemotherapy-naive patients with histologically confirmed TNBC after primary surgery to receive either six cycles of TP (docetaxel: 75 mg/m 2 or paclitaxel 175 mg/m 2 d1; carboplatin AUC = 5, day 1), or four cycles of EC (epirubicin: 90 mg/m 2 ; cyclophosphamide: 600 mg/m 2 , day 1) followed by four cycles of T (docetaxel: 75 mg/m 2 or paclitaxel 175 mg/m 2 , day 1). The primary end point was the disease-free survival (DFS) rate at 5 years. Both regimens were repeated every 3 weeks. The prognostic and predictive value of germline breast cancer gene mutations and programmed death ligand-1 (PD-L1) expression was evaluated.
RESULTS
At a median follow-up of 66.9 months, the 5-year DFS rate was 85.8% in the EC-T arm, and 84.4% in the TP arm (p non-inferiority = 0.034, p log-rank = 0.712). The 5-year overall survival (OS) rate was 94.4% in the EC-T arm and 93.5% in the TP arm (p = 0.770). Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1-4 thrombocytopenia than those in the EC-T arm. Patients with PD-L1 expressing tumors showed significantly improved DFS and OS.
CONCLUSIONS
This study indicates that carboplatin plus taxanes could be a feasible adjuvant chemotherapy for patients with early TNBC who are cannot tolerate intensive chemotherapy with anthracycline.",2020,"Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1-4 thrombocytopenia than those in the EC-T arm.","['patients with early TNBC who are cannot tolerate intensive chemotherapy with', 'early triple-negative breast cancer', '308 chemotherapy-naive patients with histologically confirmed TNBC after primary surgery']","['carboplatin plus taxanes', 'cyclophosphamide', 'TP (docetaxel: 75\xa0mg/m 2 or paclitaxel 175\xa0mg/m 2 d1; carboplatin AUC', 'T (docetaxel: 75\xa0mg/m 2 or paclitaxel', 'epirubicin plus cyclophosphamide', 'Carboplatin plus taxanes', 'EC (epirubicin', 'anthracycline']","['5-year DFS rate', '5-year overall survival (OS) rate', 'frequencies of G3/4 neutrocytopenia and G3/4 alopecia', 'rates of G1-4 thrombocytopenia', 'DFS and OS', 'disease-free survival (DFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",308.0,0.0638024,"Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1-4 thrombocytopenia than those in the EC-T arm.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Du', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Wenmiao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shandong Cancer Hospital/Institute, Jinan, 250117, Shandong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Beijing Luhe Hospital, Capital Medical University, Beijing, 101100, China.'}, {'ForeName': 'Anjie', 'Initials': 'A', 'LastName': 'Zhu', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Todorovic', 'Affiliation': 'Clinical Centre of MontenegroClinic for Oncology and Radiotherapy, Podgorica, Montenegro.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. yuanpeng01@hotmail.com.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. xubingheBM@163.com.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05648-9']
136,32396131,A Sexual Health Promotion App for Transgender Women (Trans Women Connected): Development and Usability Study.,"BACKGROUND
HIV severely impacts the transgender communities in the United States, and transgender women have the highest HIV incidence rates among any identified risk group. Guided by formative research with transgender women and by an expert advisory panel of transgender women, we designed a prototype mobile app to promote HIV prevention among transgender women.
OBJECTIVE
This study aimed to develop and test the usability and acceptability of the prototype Trans Women Connected mobile app.
METHODS
We engaged in a 3-phase prototype development process. After conducting formative research about the health needs of this population, we outlined a theory-based app framework and developed three prototype activities (ie, a vision board, a pre-exposure prophylaxis [PrEP] education activity, and an interactive map). We then tested the usability and acceptability of the mobile app and activities with 16 transgender women using pre- and posttests, think-aloud protocols, and open-ended questions.
RESULTS
Participants reported high acceptability for the mobile app; the mean rating across all usability and likability questions was 5.9 out of 7. Service utilization intention, goal setting, and social support increased at posttest compared with pretest. Increases in self-efficacy in finding lesbian, gay, bisexual, transgender, and queer-friendly services; intention to seek online social support; and PrEP knowledge were statistically significant. Participants described the app as attractive and useful and perceived all three activities positively.
CONCLUSIONS
This study describes the development and usability and acceptability evaluation of a prototype mobile app designed for and with transgender women for HIV prevention. The usability testing findings provided important insights toward refining and the further development of the Trans Women Connected mobile app. The results suggest that a mobile health intervention can support positive changes. The remaining development and efficacy randomized trial of the Trans Women Connected mobile app is currently underway.",2020,"Service utilization intention, goal setting, and social support increased at posttest compared with pretest.","['transgender women for HIV prevention', 'Transgender Women (Trans Women Connected']","['prototype Trans Women Connected mobile app', 'mobile health intervention']","['mean rating across all usability and likability questions', 'Service utilization intention, goal setting, and social support', 'usability and acceptability', 'self-efficacy']","[{'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",16.0,0.0849745,"Service utilization intention, goal setting, and social support increased at posttest compared with pretest.","[{'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Sun', 'Affiliation': 'School of Public Health, Oregon Health & Science University-Portland State University, Portland, OR, United States.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Anderson', 'Affiliation': 'School of Public Health, Oregon Health & Science University-Portland State University, Portland, OR, United States.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Kuhn', 'Affiliation': 'dfusion, Scotts Valley, CA, United States.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Mayer', 'Affiliation': 'Department of Anthropology, Portland State University, Portland, OR, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Klein', 'Affiliation': 'Department of Anthropology, Portland State University, Portland, OR, United States.'}]",JMIR mHealth and uHealth,['10.2196/15888']
137,32396179,Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.,"Importance
Humeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend.
Objective
To compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures.
Design, Setting, and Participants
Randomized clinical trial conducted at 2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019. A total of 82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion. Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma.
Interventions
Patients were randomly assigned to surgical treatment with open reduction and internal plate fixation (n = 38) or to nonsurgical treatment with functional bracing (n = 44).
Main Outcome and Measure
The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 12 months (range, 0 to 100 points, 0 denotes no disability and 100 extreme disability; minimal clinically important difference, 10 points).
Results
Among 82 patients who were randomized (mean age, 48.9 years; 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial. Thirteen (30%) of the patients assigned to functional bracing underwent surgery during the 12-month follow-up period to promote healing of the fracture. At 12 months, the mean DASH score was 8.9 (95% CI, 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group (between-group difference, -3.1 points; 95% CI, -9.6 to 3.3; P = .34). Eleven patients (25%) allocated to functional bracing developed fracture nonunion. Three patients (8%) allocated to surgery developed a temporary radial nerve palsy.
Conclusions and Relevance
Among patients with closed humeral shaft fracture, internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months. However, the substantial amount of treatment crossover from nonoperative to surgical treatment should be considered when interpreting the trial results.
Trial Registration
ClinicalTrials.gov Identifier: NCT01719887.",2020,"The primary outcome was Disabilities of Arm, Shoulder and Hand","['closed humeral shaft fractures', 'patients with closed humeral shaft fracture, internal fixation surgery', ' 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial', 'Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma', 'Patients', '2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019', '82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion', 'With Closed Displaced Humeral Shaft Fractures', '82 patients who were randomized (mean age, 48.9 years']","['surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing', 'Surgery vs Functional Bracing', 'surgical treatment with open reduction and internal plate fixation (n\u2009=\u200938) or to nonsurgical treatment with functional bracing (n\u2009=\u200944']","['mean DASH score', 'Disabilities of Arm, Shoulder and Hand', 'DASH) score', 'functional outcomes', 'fracture nonunion']","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016665', 'cui_str': 'Fracture, ununited'}]",82.0,0.141729,"The primary outcome was Disabilities of Arm, Shoulder and Hand","[{'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Rämö', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Bakir O', 'Initials': 'BO', 'LastName': 'Sumrein', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Lepola', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Lähdeoja', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Mdas AB, Ystad, Sweden.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.3182']
138,32396180,Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.,"Importance
Individually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear.
Objective
To assess the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up.
Design, Setting, and Participants
Randomized clinical trial conducted at a Swiss university hospital. Participants (N = 220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017. The last participant visit occurred on August 15, 2017.
Interventions
Participants were randomized to biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n = 111) or to control footwear (n = 109) that had visible outsole pods that were not adjustable and did not create a convex walking surface.
Main Outcomes and Measures
The primary outcome was knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms). The secondary outcomes included WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms) at 24 weeks of follow-up, and serious adverse events.
Results
Among the 220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up. At 24 weeks of follow-up, the mean standardized WOMAC pain subscore improved from 4.3 to 1.3 in the biomechanical footwear group and from 4.0 to 2.6 in the control footwear group (between-group difference in scores at 24 weeks of follow-up, -1.3 [95% CI, -1.8 to -0.9]; P < .001). The results were consistent for WOMAC physical function subscore (between-group difference, -1.1 [95% CI, -1.5 to -0.7]), WOMAC stiffness subscore (between-group difference, -1.4 [95% CI, -1.9 to -0.9]), and WOMAC global score (between-group difference, -1.2 [95% CI, -1.6 to -0.8]) at 24 weeks of follow-up. Three serious adverse events occurred in the biomechanical footwear group compared with 9 in the control footwear group (2.7% vs 8.3%, respectively); none were related to treatment.
Conclusions and Relevance
Among participants with knee pain from osteoarthritis, use of biomechanical footwear compared with control footwear resulted in an improvement in pain at 24 weeks of follow-up that was statistically significant but of uncertain clinical importance. Further research would be needed to assess long-term efficacy and safety, as well as replication, before reaching conclusions about the clinical value of this device.
Trial Registration
ClinicalTrials.gov Identifier: NCT02363712.",2020,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","['Swiss university hospital', 'Participants (N\u2009=\u2009220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017', '220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up', 'People With Knee Osteoarthritis', 'people with symptomatic knee osteoarthritis', 'participants with knee pain from osteoarthritis']","['Biomechanical Footwear', 'biomechanical footwear therapy', 'calibrated biomechanical footwear therapy', 'biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n\u2009=\u2009111) or to control footwear (n\u2009=\u2009109) that had visible outsole pods that were not adjustable and did not create a convex walking surface']","['pain and physical function', 'WOMAC physical function subscore', 'WOMAC stiffness subscore', 'Knee Pain', 'serious adverse events', 'pain', 'knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms', 'mean standardized WOMAC pain subscore', 'WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms', 'WOMAC global score']","[{'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",220.0,0.172357,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Reichenbach', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, England.'}, {'ForeName': 'Cesar A', 'Initials': 'CA', 'LastName': 'Hincapié', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heldner', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Lenz', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Harald M', 'Initials': 'HM', 'LastName': 'Bonel', 'Affiliation': 'Department for Diagnostic, Interventional, and Pediatric Radiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Jones', 'Affiliation': 'Centre for Health Sciences Research, School of Health Sciences, University of Salford Manchester, Manchester, England.'}, {'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': 'Hawker', 'Affiliation': 'Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}]",JAMA,['10.1001/jama.2020.3565']
139,32338001,Urine Metabolome Profiling Reveals Imprints of Food Heating Processes after Dietary Intervention with Differently Cooked Potatoes.,"Heat treatment is a widely used method for food processing, and the compounds formed by heat processes may serve as biomarkers of heated food intake in nutrition studies. Therefore, we aimed to characterize the differential metabolic signatures resulting from intake of different potato products and identify potential intake biomarkers. In a randomized, controlled, crossover meal study, healthy volunteers consumed boiled rice, boiled potatoes, and two deep-fried potato products, potato chips and French fries. The urine metabolome was acquired by LC-MS-based untargeted metabolomics. Twenty-two selected metabolites were found for deep-fried potatoes, two for potato intake in general, and one for boiled rice. Fourteen of the 22 selected metabolites were tentatively identified as furan-, pyrrole- and pyrazine-derived compounds indicative of Maillard reactions. With further validation, these candidate biomarkers will be important tools to investigate the influence of heated foods on human health.",2020,"Fourteen of the 22 selected metabolites were tentatively identified as furan-, pyrrole- and pyrazine- derived compounds indicative of Maillard reactions.",['healthy volunteers consumed'],"['boiled rice, boiled potatoes, and 2 deep-fried potato products, potato chips and French fries']",['urine metabolome'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242301', 'cui_str': 'Furuncle'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0453152', 'cui_str': 'Boiled potato'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0349380', 'cui_str': 'Potato chips'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}]",22.0,0.0175233,"Fourteen of the 22 selected metabolites were tentatively identified as furan-, pyrrole- and pyrazine- derived compounds indicative of Maillard reactions.","[{'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg 1958, Denmark.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Ulaszewska', 'Affiliation': ""Department of Food Quality and Nutrition, Fondazione Edmund Mach, Research and Innovation Centre, San Michele all'Adige 38010, Italy.""}, {'ForeName': 'Cătălina', 'Initials': 'C', 'LastName': 'Cuparencu', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg 1958, Denmark.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'De Gobba', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg 1958, Denmark.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Vázquez-Manjarrez', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg 1958, Denmark.'}, {'ForeName': 'Gözde', 'Initials': 'G', 'LastName': 'Gürdeniz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg 1958, Denmark.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Food Science and Technology, School of Food Science and Technology, Jiangnan University, Wuxi 214122, China.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Mattivi', 'Affiliation': ""Department of Food Quality and Nutrition, Fondazione Edmund Mach, Research and Innovation Centre, San Michele all'Adige 38010, Italy.""}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg 1958, Denmark.'}]",Journal of agricultural and food chemistry,['10.1021/acs.jafc.0c01136']
140,32396972,Effect of Sodium Bicarbonate Mouth Wash on Salivary pH and Interleukin-1β Levels among Smokers.,"OBJECTIVE
Smoking induces changes in salivary pH and inflammatory biomarker levels associated with oral diseases. This study examined the effect of alkaline oral rinse to modify this effect of smoking on salivary study parameters.
MATERIALS AND METHODS
A double-blind randomized controlled trial (RCT) on systemically healthy smokers was conducted. A total of 78 smokers, aged 18 to 40 years, were enrolled as per exclusion/inclusion criteria. An alkaline mouthwash was provided to the intervention group and a placebo to control group. Salivary pH and inflammatory biomarker interleukin (IL)-1β levels were evaluated at baseline and at follow-up (14 ± 2 days).
STATISTICAL ANALYSIS
Chi-squared test, independaent t -test, and paired t -test were used to observe the changes in parameters among and between groups before and after intervention using SPSS v16 with a significance level of p ≤0.050.
RESULTS
Sixty eight salivary samples were analyzed. All study parameters of the study sample were statistically insignificant between both intervention and control groups at baseline. pH level was 6.56 ± 0.53 at baseline and 6.62 ± 0.45 at follow-up in the intervention group; respective values for control group were 6.70 ± 0.36 and 6.83 ± 0.44 and the changes were not significant ( p ≥0.071). IL-1β level was 9.39 ± 10.23 pg/µL at baseline and 5.40 ± 6.62 pg/µL at a follow-up in the intervention group and the change was significant ( p = 0.001); respective values for the control group were 10.63 ± 11.50, and 9.33 ± 11.73 and the difference was nonsignificant ( p = 0.076).
CONCLUSION
This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.",2020,This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.,"['78 smokers, aged 18 to 40 years, were enrolled as per exclusion/inclusion criteria', 'systemically healthy smokers', 'Smokers']","['alkaline oral rinse', 'Sodium Bicarbonate Mouth Wash', 'sodium bicarbonate mouth rinse', 'placebo']","['IL)-1β levels', 'Salivary pH and inflammatory biomarker interleukin', 'IL-1β levels', 'IL-1β level', 'Salivary pH and Interleukin-1β Levels', 'pH level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1304686', 'cui_str': 'pH - finding'}]",78.0,0.107795,This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.,"[{'ForeName': 'Syed Ameer', 'Initials': 'SA', 'LastName': 'Hamza', 'Affiliation': 'Department of Oral Medicine, College of Dentistry, The University of Faisalabad, Faisalabad, Pakistan.'}, {'ForeName': 'Arsalan', 'Initials': 'A', 'LastName': 'Wahid', 'Affiliation': 'Department of Pathology, College of Dentistry, The University of Faisalabad, Faisalabad, Pakistan.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Afzal', 'Affiliation': 'Department of Immunology, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Asif', 'Affiliation': 'Department of Periodontology, University Sains Malaysia, Kelantan, Malaysia.'}, {'ForeName': 'Mian Farrukh', 'Initials': 'MF', 'LastName': 'Imran', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, The University of Faisalabad, Faisalabad, Pakistan.'}, {'ForeName': 'Zohaib', 'Initials': 'Z', 'LastName': 'Khurshid', 'Affiliation': 'Department of Prosthodontics and Dental Implantology, College of Dentistry, King Faisal University, Al-Ahsa, Kingdom of Saudi Arabia.'}, {'ForeName': 'Syed Akhtar Hussain', 'Initials': 'SAH', 'LastName': 'Bokhari', 'Affiliation': 'Department of Preventive Dental Sciences, College of Dentistry, King Faisal University, Al-Ahsa, Kingdom of Saudi Arabia.'}]",European journal of dentistry,['10.1055/s-0040-1709896']
141,32383050,Effect of mirtazapine on pruritus in patients on hemodialysis: a cross-over pilot study.,"BACKGROUND
Uremic pruritus (UP) is a highly prevalent and disturbing problem in patients with advanced chronic kidney disease (CKD); however, treatment of UP is largely unsatisfactory. The present study was designed to investigate the effectiveness of mirtazapine, an atypical antidepressant agent with potent antagonistic activity against serotonin (5HT2, 5HT3) and histamine (H1) receptors, in the treatment of pruritus in hemodialysis (HD) patients.
METHODS
An 8-week long, prospective, open-label, and cross-over randomized clinical trial study was conducted on 77 HD patients with chronic pruritus. After a 2-week washout period, eligible patients were randomly assigned either to the mirtazapine (15 mg per day) or gabapentin (100 per day) for 2 weeks. Following 2 weeks washout period, subjects crossed over to the other treatment arm for 2 more weeks. The severity of pruritus was measured seven times during each treatment period using the visual analogue scale (VAS). Furthermore, at the end of the study, patients also were blindly asked which treatment (first or last in the sequential course of the study) they preferred.
RESULTS
Sixty-one patients completed two treatment periods of the study. Although, compared to baseline, both gabapentin and mirtazapine treatment resulting in significant improvement in VAS scores, decreasing in pruritus severity was significantly greater in the mirtazapine treatment period compared with the gabapentin treatment period (P < 0.001). Furthermore, although side effects such as drowsiness and dry mouth more reported in the mirtazapine treatment period, overall higher percentage of the study patients preferred mirtazapine over gabapentin for the treatment of their pruritus symptoms.
CONCLUSIONS
Although preliminary, our study provides evidence that mirtazapine can be an effective therapy for UP in patients who are on maintenance HD. However, further studies would be necessary to confirm effectiveness as well as the safety of mirtazapine in the long-term management of chronic pruritus.",2020,"Although, compared to baseline, both gabapentin and mirtazapine treatment resulting in significant improvement in VAS scores, decreasing in pruritus severity was significantly greater in the mirtazapine treatment period compared with the gabapentin treatment period (P < 0.001).","['77 HD patients with chronic pruritus', 'patients who are on maintenance HD', 'pruritus in hemodialysis (HD) patients', 'patients with advanced chronic kidney disease (CKD', 'patients on hemodialysis', 'Sixty-one patients completed two treatment periods of the study']","['gabapentin', 'mirtazapine']","['visual analogue scale (VAS', 'severity of pruritus', 'pruritus severity', 'VAS scores']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",77.0,0.0178438,"Although, compared to baseline, both gabapentin and mirtazapine treatment resulting in significant improvement in VAS scores, decreasing in pruritus severity was significantly greater in the mirtazapine treatment period compared with the gabapentin treatment period (P < 0.001).","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Gholyaf', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Sheikh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yasrebifar', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, 6517838678, Hamadan, Iran.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Mohammadi', 'Affiliation': 'Modeling of Non-Communicable Diseases Research Center, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mahtabalsadat', 'Initials': 'M', 'LastName': 'Mirjalili', 'Affiliation': 'Clinical Pharmacy Resident, Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mehrpooya', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, 6517838678, Hamadan, Iran. m_mehrpooya2003@yahoo.com.'}]",International urology and nephrology,['10.1007/s11255-020-02473-3']
142,32383100,Télépied Study: A Single-Centre Trial in Diabetic Subjects Comparing Total Duration of Hospitalization Over a 1-Year Period Required for Complete Healing of a Foot Ulcer Using Telemedicine Management and a Referral Nurse Versus the Standard Care Pathway.,"PURPOSE
The aim of this study is to demonstrate that the total number of days in hospital required for healing of a de novo diabetes-related foot ulcer (DFU) is lower in patients followed up using a telemedicine platform (Télépied Follow-Up group [Group 2]) than in patients followed up using standard care (Standard Follow-Up control group [Group 1]). Patients are assigned to either Group 1 or Group 2 depending on whether their first inclusion visit is during an even or odd week. Patients included in Group 1 are to be followed at spaced intervals during day hospital visits by the investigator assisted by a specialized referral nurse as part of the regular follow-up procedure (dressing changes + ulcer monitoring). Between visits, an independent nurse (IN) provides local care on a daily basis. Patients included in Group 2 have their DFU treated by a referral nurse trained at the diabetic foot unit of the investigating centre, and they are also followed up by an IN under the supervision of a referral nurse. In Group 2, monitoring of lesions is performed weekly by the referral nurse using photos of the DFU with planimetry taken by the IN and sent to the referral nurse via telemedicine software. The referral nurse can, in turn, provide guidance to the IN on the care to be provided and/or decide that a further hospital visit is needed. Both treatment groups are to be followed for 12 months or until complete healing of the ulcer.
RESULTS
Recruitment for the study began in March 2017 and ended in May 2019, with the final study visit scheduled for May 2020.
CONCLUSION
The aim of the Télépied study is to assess the impact of ambulatory foot ulcer management in diabetics over a 1-year period by a non-specialized IN working under the supervision of a referral nurse via telemedicine follow-up versus standard follow-up by an IN alone. The primary endpoint is the total duration of hospitalization required until full healing of the ulcer.",2020,Patients are assigned to either Group 1 or Group 2 depending on whether their first inclusion visit is during an even or odd week.,"['diabetics over a 1-year period by a non-specialized IN working under the supervision of a referral nurse via', 'Patients included in Group 2 have their DFU treated by a referral nurse trained at the diabetic foot unit of the investigating centre, and they are also followed up by an IN under the supervision of a referral nurse', 'Diabetic Subjects']","['telemedicine follow-up versus standard follow-up by an IN alone', 'investigator assisted by a specialized referral nurse as part of the regular follow-up procedure (dressing changes\u2009+\u2009ulcer monitoring']","['Complete Healing of a Foot Ulcer', 'total duration of hospitalization required until full healing of the ulcer']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",,0.0168346,Patients are assigned to either Group 1 or Group 2 depending on whether their first inclusion visit is during an even or odd week.,"[{'ForeName': 'Dured', 'Initials': 'D', 'LastName': 'Dardari', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France. dured.dardari@gmail.com.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Franc', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Bobony', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Demangeon', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bouly', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Ilham', 'Initials': 'I', 'LastName': 'Xhaard', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alhajj', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Kadijatou Ly', 'Initials': 'KL', 'LastName': 'Sall', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Randazzo', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00821-1']
143,32380917,Effects of combined physical and cognitive training on fall prevention and risk reduction in older persons with mild cognitive impairment: a randomized controlled study.,"OBJECTIVE
The aim of this study is to investigate the effects of combined physical and cognitive training on fall rate and risks of falling in older adults with mild cognitive impairment.
DESIGN
The design of this study was an assessor-blinded, randomized controlled trial.
SETTING
The setting for this study is the community from Manila, Philippines.
SUBJECTS
In total, 92 community-dwelling older persons with mild cognitive impairment (aged 60-83) were randomly allocated to three intervention groups and one waitlist control group.
INTERVENTIONS
The physical training, cognitive training, and combined physical and cognitive training intervention programs were delivered for 60 to 90 minutes, one to three times per week for 12 weeks with six-month follow-up.
MAIN MEASURES
Participants were assessed at baseline, 12 weeks after baseline, and 36 weeks after baseline for fall incidence, overall fall risk, dynamic balance, walking speed, and lower limb strength.
RESULTS
No significant difference was observed across time and groups on fall incidence rate at 12 weeks ( P = 0.152) and at 36 weeks ( P = 0.954). The groups did not statistically differ in other measures except for a significant improvement in dynamic balance based on Timed Up and Go Test in the combined physical and cognitive training group (9.0 seconds with P = 0.001) and in the cognitive training alone group (8.6 seconds with P = 0.012) compared to waitlist group (11.1 seconds) at 36 weeks.
CONCLUSION
There was no significant difference among groups on fall rate and risks of falling post-intervention. Dynamic balance was improved with combined physical and cognitive training and cognitive training alone. Further research with a larger sample size is needed to establish whether or not the interventions are effective.",2020,"The groups did not statistically differ in other measures except for a significant improvement in dynamic balance based on Timed Up and Go Test in the combined physical and cognitive training group (9.0 seconds with P = 0.001) and in the cognitive training alone group (8.6 seconds with P = 0.012) compared to waitlist group (11.1 seconds) at 36 weeks.
","['community from Manila, Philippines', 'older persons with mild cognitive impairment', 'older adults with mild cognitive impairment', '92 community-dwelling older persons with mild cognitive impairment (aged 60-83']","['combined physical and cognitive training and cognitive training alone', 'combined physical and cognitive training', 'waitlist control group', 'physical training, cognitive training, and combined physical and cognitive training intervention programs']","['dynamic balance based on Timed Up and Go Test', 'fall rate and risks of falling', 'fall rate and risks of falling post-intervention', 'fall prevention and risk reduction', 'Dynamic balance', 'fall incidence rate', 'fall incidence, overall fall risk, dynamic balance, walking speed, and lower limb strength']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",92.0,0.0203484,"The groups did not statistically differ in other measures except for a significant improvement in dynamic balance based on Timed Up and Go Test in the combined physical and cognitive training group (9.0 seconds with P = 0.001) and in the cognitive training alone group (8.6 seconds with P = 0.012) compared to waitlist group (11.1 seconds) at 36 weeks.
","[{'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Lipardo', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'William Wn', 'Initials': 'WW', 'LastName': 'Tsang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}]",Clinical rehabilitation,['10.1177/0269215520918352']
144,32381495,Video observed therapy (VOT) and medication adherence for TB patients: RCT in Moldova.,"INTRODUCTION
The effectiveness of Video Observed Therapy (VOT) for treating Tuberculosis (TB) has not been measured in low and middle-income countries (LMICs), where more than 95% of TB cases and deaths occur. In this study, we analyse the effectiveness, and patient cost-difference, of VOT compared to clinic-based Directly Observed Therapy (DOT) in improving medication adherence in Moldova, a LMIC in Eastern Europe.
METHODS
The study was a 2-arm individually randomised trial with 197 TB patients (n=99 in DOT control group; 98 in VOT treatment group, MDR-TB cases were excluded). The primary outcome was observed medication adherence, measured by the number of days that a patient failed to be observed adhering to medication for every two-week period during the course of their treatment RESULTS: VOT significantly decreased non-adherence by 4 days (95% CI, 3.35 to 4.67 days; p<0.01) per two-week period: 5.24 days missed per two-week period for DOT and 1.29 days for VOT. VOT patients spent 504 Moldovan Leu (MDL) (approximately €25; 95% CI, 277 to 730 MDL; p<0.01) and 58 h (95% CI, 48 to 68 h; p<0.01) less on their treatment. VOT also increased self-reported satisfaction with treatment. We found no significant results pertaining to treatment success, patient well-being or patient employment status and some evidence of an increase in side effects.
DISCUSSION
In this trial, Video Observed Therapy (VOT) increased observed medication adherence for tuberculosis patients in Moldova, a LMIC, when compared to clinic-based Directly Observed Therapy (DOT). VOT also significantly reduced the time and money patients spent on their treatment.",2020,"We found no significant results pertaining to treatment success, patient well-being or patient employment status and some evidence of an increase in side effects.
","['Moldova, a LMIC in Eastern Europe', '197 TB patients (n=99 in DOT control group; 98 in VOT treatment group, MDR-TB cases were excluded', 'TB patients: RCT in Moldova']","['Video observed therapy (VOT', 'Video Observed Therapy (VOT', 'clinic-based Directly Observed Therapy (DOT', 'VOT']","['medication adherence', 'number of days that a patient failed to be observed adhering to medication', 'VOT', 'VOT patients spent 504 Moldovan Leu (MDL', 'side effects']","[{'cui': 'C0026374', 'cui_str': 'Moldavia'}, {'cui': 'C0015177', 'cui_str': 'East European country'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206526', 'cui_str': 'Multidrug resistant tuberculosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",197.0,0.085522,"We found no significant results pertaining to treatment success, patient well-being or patient employment status and some evidence of an increase in side effects.
","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Ravenscroft', 'Affiliation': 'Behavioural Insights Team, London, England luke.ravenscroft@bi.team.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Kettle', 'Affiliation': 'Behavioural Insights Team, London, England.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Persian', 'Affiliation': 'Behavioural Insights Team, London, England.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ruda', 'Affiliation': 'Behavioural Insights Team, London, England.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Severin', 'Affiliation': 'Act For Involvement, Chișinău, Moldova.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Doltu', 'Affiliation': 'Act For Involvement, Chișinău, Moldova.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Schenck', 'Affiliation': 'Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Carnegie Mellon University, Pittsburgh, PA, USA.'}]",The European respiratory journal,['10.1183/13993003.00493-2020']
145,32383767,"Effect of oral consumption of capsules containing Lactobacillus paracasei LPC-S01 on the vaginal microbiota of healthy adult women: a randomized, placebo-controlled, double-blind crossover study.","Oral consumption of probiotics is practical and can be an effective solution to preserve vaginal eubiosis. Here, we studied the ability of orally administered Lactobacillus paracasei LPC-S01 (DSM 26760) to affect the composition of the vaginal microbiota and colonize the vaginal mucosa in nondiseased adult women. A total of 40 volunteers took oral probiotic (24 billion CFU) or placebo capsules daily for 4 weeks, and after a 4-week washout, they switched to placebo or probiotic capsules according to the crossover design. A total of 23 volunteers completed the study according to the protocol. Before and after capsule ingestion, vaginal swabs were collected for qPCR quantification to detect L. paracasei LPC-S01 and for 16S rRNA gene sequencing. Vaginal swabs were grouped according to their bacterial taxonomic structure into nine community state types (CSTs), four of which were dominated by lactobacilli. Lactobacillus paracasei LPC-S01 was detected in the vagina of two participants. Statistical modeling (including linear mixed-effects model analysis) demonstrated that daily intake of probiotic capsules reduced the relative abundance of Gardnerella spp. Quantitative PCR with Gardnerella vaginalis primers confirmed this result. Considering the pathogenic nature of G. vaginalis, these results suggest a potential positive effect of this probiotic capsule on the vaginal microbial ecosystem.",2020,"Before and after capsule ingestion, vaginal swabs were collected for qPCR quantification to detect L. paracasei LPC-S01 and for 16S rRNA gene sequencing.","['healthy adult women', 'Twenty-three volunteers completed the study according to the protocol', 'nondiseased adult women', 'Forty volunteers took']","['oral probiotic (24 billion CFU) or placebo', 'Lactobacillus paracasei LPC-S01 (DSM26760', 'oral consumption of capsules containing Lactobacillus paracasei LPC-S01', 'placebo']","['relative abundance of Gardnerella spp', 'L. paracasei LPC-S01', 'vaginal microbiota']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",40.0,0.149525,"Before and after capsule ingestion, vaginal swabs were collected for qPCR quantification to detect L. paracasei LPC-S01 and for 16S rRNA gene sequencing.","[{'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Koirala', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gargari', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Arioli', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Taverniti', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiore', 'Affiliation': 'Sofar S.p.A., Via Firenze 40, 20060, Trezzano Rosa (MI), Trezzano Rosa, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Grossi', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Unit of Obstetrics and Gynecology, ASST Fatebenefratelli Sacco University Hospital, University of Milan, Via Giovanni Battista Grassi 74, 20157, Milan, Italy.'}, {'ForeName': 'Gaia Maria', 'Initials': 'GM', 'LastName': 'Anelli', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Unit of Obstetrics and Gynecology, ASST Fatebenefratelli Sacco University Hospital, University of Milan, Via Giovanni Battista Grassi 74, 20157, Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cetin', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Unit of Obstetrics and Gynecology, ASST Fatebenefratelli Sacco University Hospital, University of Milan, Via Giovanni Battista Grassi 74, 20157, Milan, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Guglielmetti', 'Affiliation': 'Division of Food Microbiology and Bioprocesses, Department of Food, Environmental and Nutritional Sciences, University of Milan, via Luigi Mangiagalli 25, 20133, Milan, Italy.'}]",FEMS microbiology ecology,['10.1093/femsec/fiaa084']
146,32383985,"Correction: A comparative, single-blind, randomized study on quetiapine and aripiperazole augmentation in treatment of selective serotonin reuptake inhibitor refractory obsessive-compulsive disorder.",,2020,,[],['quetiapine and aripiperazole augmentation'],[],[],"[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]",[],,0.0158538,,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Talaei', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Farhad Farid', 'Initials': 'FF', 'LastName': 'Hosseini', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Aghili', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Asadpour', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Neema John', 'Initials': 'NJ', 'LastName': 'Mehramiz', 'Affiliation': 'The University of Arizona, College of Medicine, Tucson, AZ 85724, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Forouzanfar', 'Affiliation': 'Neuroscience Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Canadian journal of physiology and pharmacology,['10.1139/cjpp-2020-0207']
147,32384175,Testosterone replacement therapy: Pre-treatment sex hormone-binding globulin levels and age may identify clinical subgroups.,"BACKGROUND
Testosterone replacement therapy (TRT) improves health in some but not all men with type 2 diabetes (T2DM) and adult-onset testosterone deficiency (TD). Such heterogeneity is compatible with the concept of patient subgroups that respond differently to therapy.
OBJECTIVES
Use baseline SHBG and age to identify putative subgroups that demonstrate different responses in variables such as waist circumference and HbA1c following TRT.
MATERIALS AND METHODS
A randomized double-blind trial approach was used to recruit and randomize men with T2DM and adult-onset TD into placebo and TRT-treated groups. Multiple regression was used to study differences between groups.
RESULTS
Baseline SHBG and change in SHBG (∆SHBG) were inversely related in the TRT group. Both median values of SHBG and age mediated the effect of TRT on ∆SHBG depending on whether baseline values were ≤ or>median (28.1 nmol/L, 63 years, respectively). In men with both SHBG ≤ 28.1 nmol/L and age ≤ 63 years (subgroup 1), TRT was positively associated with ∆SHBG (c = 4.67, 95%CI 1.17-8.16, P = .010) while in those with SHBG > 28.1 nmol/L and age > 63.1 years (subgroup 4) the association was inverse (c = -7.07, 95%CI -11.64 to -2.49, P = .003). The association between TRT and change (∆) in waist circumference, HbA1c and International Index of Erectile Function (IIEF) score differed between subgroups; in subgroup 4 but not subgroup 1, the therapy was significantly associated with ∆waist circumference, ∆HbA1c and ∆IIEF.
DISCUSSION
Though the mechanism remains unclear, our finding of different responses to TRT in terms of change in waist circumference, HbA1c and IIEF score supports the concept of subgroups in men with T2DM and adult-onset TD.
CONCLUSION
Our approach may provide a basis for identifying men who will or will not derive benefit from TRT though a larger study is required.",2020,"Both median values of SHBG and age mediated the effect of TRT on ∆SHBG depending on whether baseline values were ≤ or >median (28.1nmol/l, 63 years respectively).","['randomise men with T2DM and adult onset TD into placebo and TRT treated groups', 'men with type 2 diabetes (T2DM) and adult onset testosterone deficiency (TD']","['Testosterone replacement therapy (TRT', 'Testosterone replacement therapy: Pre-treatment sex hormone binding globulin levels', 'TRT']","['TRT and change (∆) in waist circumference, HbA1c and International Index of Erectile Function (IIEF) score', 'waist circumference, HbA1c and IIEF score', 'Baseline SHBG and change in SHBG (∆SHBG']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1963961', 'cui_str': 'Testosterone deficiency'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C2959364', 'cui_str': 'International index of erectile function score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.239468,"Both median values of SHBG and age mediated the effect of TRT on ∆SHBG depending on whether baseline values were ≤ or >median (28.1nmol/l, 63 years respectively).","[{'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Health Sciences, University Hospitals of North Midlands, Staffordshire University, Stoke-on-Trent, UK.'}, {'ForeName': 'Geoffrey I', 'Initials': 'GI', 'LastName': 'Hackett', 'Affiliation': 'School of Health and Life Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Strange', 'Affiliation': 'Institute for Science and Technology in Medicine, Keele University, Keele, UK.'}]",Andrology,['10.1111/andr.12813']
148,32322972,[Pain physicians should not turn a blind eye: what happens when a medical product manufacturer ceases providing equipment?],,2020,,[],[],[],[],[],[],,0.032341,,"[{'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'May', 'Affiliation': 'Institut für Systemische Neurowissenschaften, Universitätsklinikum Hamburg-Eppendorf, Martinistraße\xa052, 20246, Hamburg, Deutschland. a.may@uke.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Evers', 'Affiliation': 'Neurologische Klinik, Krankenhaus Lindenbrunn, 1120, 31861, Coppenbrügge, Deutschland.'}]","Schmerz (Berlin, Germany)",['10.1007/s00482-020-00470-0']
149,32384495,"A simple, efficient, and safe way of finding recurrent laryngeal nerve beneficial for PTC patients.","BACKGROUND
More surgeons have known the importance of parathyroid grand and recurrent laryngeal nerve protection in the surgery, but there is still plenty of scope to improve the surgical techniques. This study aims at investigating whether the improved method of finding recurrent laryngeal nerve (RLN) can protect parathyroid grand and RLN.
METHODS
One hundred fifty-eight patients were enrolled and divided randomly into the test and control group according to different methods of finding RLN in the surgery. In the experimental group the author could quickly find the laryngeal recurrent nerve in the lower part of the neck and separate along the surface of the recurrent laryngeal nerve to the point where the recurrent laryngeal nerve gets into the larynx close to the thyroid gland named lateral approach, while in the control group the author severed the middle and lower thyroid vein and raised the lower thyroid pole to look for the RLN near the trachea by the blunt separation.
RESULTS
The author identified 152 and 159 parathyroid glands in the test and control group, respectively and there were a lower ratio of auto-transplantation and less operative time in the test group compared with that in the control group. The author also found that the parathyroid hormone level (1 day and 2 months) in the test group was higher than that in the control group. There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
CONCLUSION
The improved method of finding RLN is a simple, efficient and safe way, and easy to implement.",2020,"There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
",['One hundred fifty-eight patients'],[],"['metastatic LN and recurrent laryngeal nerve palsy', 'parathyroid hormone level', 'lower ratio of auto-transplantation and less operative time']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0542142', 'cui_str': 'Vagus nerve laryngeal paralysis'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",158.0,0.0184314,"There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
","[{'ForeName': 'Shouyi', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}]",Medicine,['10.1097/MD.0000000000020138']
150,32384500,Multiple versus single doses of dexamethasone in total hip arthroplasty: A protocol of randomized controlled trial.,"BACKGROUND
Reduction of post-operative pain, nausea, and vomiting in patients undergoing total hip arthroplasty (THA) may facilitate earlier discharge from hospital and reduce healthcare costs. The recommended dose regimen of dexamethasone in THA has not been determined. The purpose of this study was performed to compare the efficiency of multiple versus single doses of dexamethasone for early postoperative pain treatment after THA.
METHODS
This study was a randomized controlled trial which conducted in our hospital. Informed consent for participation in this trial was obtained from each patient before surgery. Two hundred patients undergoing THA received 1 dose of intravenous dexamethasone and 1 dose of normal saline (Group A), or 2 doses of intravenous dexamethasone (Group B). The primary outcome was visual analog scale pain scores in the immediate postoperative period. Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
RESULTS
This clinical trial might provide some insights to estimate the safety of dexamethasone.
TRIAL REGISTRATION
This study protocol was registered in Research Registry (researchregistry5460).",2020,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
","['Two hundred patients undergoing', 'early postoperative pain treatment after THA', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['dexamethasone', 'normal saline', 'intravenous dexamethasone', 'THA']","['postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion', 'visual analog scale pain scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",200.0,0.478323,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
","[{'ForeName': 'Bangjian', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Shaoqiong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Operation room, Panzhihua Central Hospital.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Sheng', 'Affiliation': 'Department of Anesthesiology, West China Second University Hospital, Sichuan University, Sichuan Province, China.'}]",Medicine,['10.1097/MD.0000000000020147']
151,32384502,Comparison of high tone therapy and transcutaneous electrical nerve stimulation therapy in chemotherapy-induced polyneuropathy.,"INTRODUCTION
Chemotherapy-induced peripheral neuropathy (CIPN) is a worldwide concern in patients receiving neurotoxic agents for cancer therapy. High tone external muscle stimulation is a promising therapeutic approach to alleviate symptoms of CIPN.
METHODS
This pilot study aims to investigate whether the application of home-based high-tone external muscle stimulation therapy (HTEMS) improves symptoms of CIPN. The trial is planned as a therapist- and assessor-blinded, 1:1 randomized controlled study. A total of 50 patients with chemotherapy-induced peripheral polyneuropathy will be included. All patients will perform therapy at home. Study participants will be allocated randomly to the HTEMS therapy (intervention group) or to the transcutaneous electrical nerve stimulation (TENS, control group), respectively, following a standardized therapy schedule. Compliance of participants can be verified by reading out the tool box. Outcomes will be evaluated at baseline and after 8 weeks of home-based therapy. The primary outcome includes improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire. Secondary outcomes are the patient-reported change in health-related quality of life and clinician-reported changes of vibration sensibility, tendon reflexes, temperature sensibility, perception of touch, and strength of the lower leg muscles. Further a safety- and process evaluation will be performed.
DISCUSSION
This pilot RCT aims to evaluate the impact of home-based HTEMS as compared to TENS in CIPN. There is a need for an effective treatment for CIPN and the results of this study are expected to possibly identify a novel and effective treatment strategy in the future.",2020,The primary outcome includes improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire.,"['chemotherapy-induced polyneuropathy', '50 patients with chemotherapy-induced peripheral polyneuropathy', 'patients receiving neurotoxic agents for cancer therapy']","['HTEMS therapy (intervention group) or to the transcutaneous electrical nerve stimulation (TENS, control group', 'home-based high-tone external muscle stimulation therapy (HTEMS', 'Chemotherapy-induced peripheral neuropathy (CIPN', 'high tone therapy and transcutaneous electrical nerve stimulation therapy', 'High tone external muscle stimulation']","['improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire', 'patient-reported change in health-related quality of life and clinician-reported changes of vibration sensibility, tendon reflexes, temperature sensibility, perception of touch, and strength of the lower leg muscles']","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0034943', 'cui_str': 'Peripheral reflex'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C2350522', 'cui_str': 'Touch perception'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",50.0,0.0546638,The primary outcome includes improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire.,"[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schaffler-Schaden', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sassmann', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Johansson', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Gampenrieder', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR).'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rinnerthaler', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR).'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Lampl', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Herfert', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Lenzhofer', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'Landkammer', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rieder', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR).'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flamm', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}]",Medicine,['10.1097/MD.0000000000020149']
152,32384504,Efficacy of baby shampoo and commercial eyelid cleanser in patients with meibomian gland dysfunction: A randomized controlled trial.,"BACKGROUND
To compare the efficacy between Johnson's baby shampoo top-to-toe (No More Tears formula) and OCuSOFT Lid Scrub Original Foaming Eyelid Cleanser (OSO) in patients with grade 2 meibomian gland dysfunction (MGD).
METHODS
Sixty participants with grade 2 MGD were enrolled and analyzed based on intention to treat basis in a prospective, randomized, single-blind trial for eye scrub using either diluted baby shampoo or OSO. The data collection included the Ocular Surface Disease Index (OSDI) questionnaire, compliance, and complications. The eye examinations were according to the Tear Film and Ocular Surface Society at baseline and at post-treatment weeks 4 and 12.
RESULTS
The mean (±SD) age of the 60 patients who presented with grade 2 MGD was 48.0 ± 13.8 years and 75.0% were females. The OSDI scores of these participants between pre-treatment and post-treatment weeks 4 and 12 improved significantly in both groups (all P < .001). The mean (±SD) differences of the improvement of OSDI score from baseline were not statistically significantly different between the baby shampoo and OSO groups at post-treatment weeks 4 and 12 (P = .57 and P = .54, respectively). The compliance and complications were also not statistically significant between the 2 groups.
CONCLUSIONS
Eyelid scrub using either baby shampoo or OSO and warm compresses could significantly reduce eye irritability and uncomfortable symptoms in grade 2 MGD patients. In this study, the efficacy, compliance, and complications between the 2 groups were not statistically significantly different.",2020,The OSDI scores of these participants between pre-treatment and post-treatment weeks 4 and 12 improved significantly in both groups (all P < .001).,"['patients with meibomian gland dysfunction', '60 patients who presented with grade 2 MGD was 48.0\u200a±\u200a13.8 years and 75.0% were females', 'grade 2 MGD patients', 'patients with grade 2 meibomian gland dysfunction (MGD', 'Sixty participants with grade 2 MGD']","['baby shampoo and commercial eyelid cleanser', 'OCuSOFT Lid Scrub Original Foaming Eyelid Cleanser (OSO', 'diluted baby shampoo or OSO']","['OSDI scores', 'eye irritability and uncomfortable symptoms', 'OSDI score', 'Ocular Surface Disease Index (OSDI) questionnaire, compliance, and complications', 'compliance and complications', 'efficacy, compliance, and complications', 'Tear Film and Ocular Surface Society']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150765', 'cui_str': 'Shampoo'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0722230', 'cui_str': 'Ocusoft'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",60.0,0.0646905,The OSDI scores of these participants between pre-treatment and post-treatment weeks 4 and 12 improved significantly in both groups (all P < .001).,"[{'ForeName': 'Orapan', 'Initials': 'O', 'LastName': 'Aryasit', 'Affiliation': ''}, {'ForeName': 'Yuwarat', 'Initials': 'Y', 'LastName': 'Uthairat', 'Affiliation': ''}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Singha', 'Affiliation': ''}, {'ForeName': 'Orasa', 'Initials': 'O', 'LastName': 'Horatanaruang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020155']
153,32384509,To explore the clinical efficacy of Traditional Chinese Medicine bath in the treatment of psoriasis vulgaris with blood-heat syndrome and its effect on related cytokines based on different temperature and different concentration.,"BACKGROUND
Chinese herbal bath has long been used in the curative treatment of psoriasis vulgaris. However, there is no unified standard protocol for Chinese herbal bath. Many factors affect the curative effect of Chinese herbal bath, such as water temperature, bath concentration, and soaking time. Most studies involving Chinese herbal bath has described the bath generally, and few studies have investigated the factors that might contribute to the efficacy of Chinese herbal bath. Here we describe a protocol to evaluate the efficacy and safety of various bathwater temperatures and herbal concentrations on psoriasis vulgaris, and their effect on serum vascular endothelial growth factor (VEGF), tumor necrosis factor α (TNF-α), interleukin 23 (IL-23), and interleukin 17 (IL-17). These data could be useful for optimizing Chinese herbal bath treatments.
METHODS
In this randomized controlled trial, we planned to recruit 288 hospitalized atients with psoriasis vulgaris aged 18 to 65 years. All participants who meet the inclusion criteria will be randomly assigned to the observation group, the control group, or the basic treatment group. The observation group will be divided into 6 sub-groups according to water temperatures and bath concentrations, designated as observation groups 1 to 6. Thirty-six participants will be assigned to each group. The basic treatment group will be given co-qingdai capsule, po 2 g tid; compound glycyrrhizin tablet, po 75 mg tid; AA Skincare jojoba Oil, us.ext qd. The observation group will be given a Chinese herbal bath at the same time as the basic treatment. The control group will be given ozone hydrotherapy at the same time as the basic treatment. The entire treatment course will last for 2 weeks. The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
CONCLUSION
This study will evaluate the efficacy and safety of various Chinese herbal bath conditions (water temperatures and herbal concentrations) on the treatment of psoriasis vulgaris, which will provide an important reference for the operation of Chinese herbal bath.
TRIAL REGISTRATION NUMBER
ChiCTR1900027468.",2020,"The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
","['288 hospitalized atients with psoriasis vulgaris aged 18 to 65 years', 'psoriasis vulgaris with blood-heat syndrome']","['Traditional Chinese Medicine bath', 'glycyrrhizin tablet, po 75\u200amg tid; AA Skincare jojoba Oil, us.ext qd', 'ozone hydrotherapy', 'various Chinese herbal bath conditions (water temperatures and herbal concentrations']","['efficacy and safety', 'serum vascular endothelial growth factor (VEGF), tumor necrosis factor α (TNF-α), interleukin 23 (IL-23), and interleukin 17 (IL-17', 'psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0061751', 'cui_str': 'Glycyrrhizic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0064161', 'cui_str': 'jojoba wax'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",36.0,0.0598044,"The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
","[{'ForeName': 'Wenxia', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yuesi', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Chengdu Yinkang Psoriasis Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Chengdu Yinkang Psoriasis Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Mingling', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020172']
154,32385134,Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES
There are no US Food and Drug Administration-approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates. However, randomized studies have not been performed. Our objectives were to study the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment of neonatal seizures.
METHODS
The study was a multicenter, randomized, blinded, controlled, phase IIb trial investigating the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment for neonatal seizures of any cause. The primary outcome measure was complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists.
RESULTS
Eighty percent of patients (24 of 30) randomly assigned to phenobarbital remained seizure free for 24 hours, compared with 28% of patients (15 of 53) randomly assigned to levetiracetam ( P < .001; relative risk 0.35 [95% confidence interval: 0.22-0.56]; modified intention-to-treat population). A 7.5% improvement in efficacy was achieved with a dose escalation of levetiracetam from 40 to 60 mg/kg. More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
CONCLUSIONS
In this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed.",2020,"More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
","['Neonatal Seizures', 'neonatal seizures of any cause', 'older patients']","['levetiracetam', 'phenobarbital', 'Phenobarbital and phenytoin', 'Levetiracetam', 'Levetiracetam Versus Phenobarbital']","['complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists', 'phenobarbital remained seizure free', 'efficacy and safety', 'efficacy', 'adverse effects']","[{'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.327532,"More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant).
","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Sharpe', 'Affiliation': ""Department of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Reiner', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Davis', 'Affiliation': ""Department of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nespeca', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Gold', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Maynard', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'San Diego Neonatology Inc and.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kuperman', 'Affiliation': ""Pediatric Neurology, University of California, San Francisco Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Harbert', 'Affiliation': 'Department of Neurosciences, School of Medicine, University of California, San Diego and Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': ""Division of Pediatric Neurology, Department of Pediatrics, Loma Linda University Children's Hospital, Loma Linda, California.""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Joe', 'Affiliation': 'Division of Neonatology, Departments of Pediatrics and.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Neggy', 'Initials': 'N', 'LastName': 'Rismanchi', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California.""}, {'ForeName': 'Ngoc Minh', 'Initials': 'NM', 'LastName': 'Le', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mower', 'Affiliation': ""Department of Neurology, Children's Hospital of Orange County, Orange, California.""}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of NeoNatology, Departments of Pediatrics and.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'Battin', 'Affiliation': 'Department of Neonatology, Auckland District Health Board, Auckland, New Zealand; and.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lane', 'Affiliation': ""Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Honold', 'Affiliation': ""Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Knodel', 'Affiliation': ""Division of Neonatology, Departments of Pediatrics, University of California, San Diego and Rady Children's Hospital San Diego, San Diego, California.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Arnell', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Bridge', 'Affiliation': 'Division of NeoNatology, Departments of Pediatrics and.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Neurosciences, School of Medicine, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ernstrom', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Raman', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Haas', 'Affiliation': ""Department of Neurosciences, School of Medicine, University of California, San Diego and Rady Children's Hospital-San Diego, San Diego, California; rhaas@health.ucsd.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2019-3182']
155,32320845,Hybrid type 1 randomized controlled trial of a tablet-based application to improve quality of care in child mental health treatment.,"The quality of child mental health care is highly variable in community practice settings. Innovative technology-based solutions may be leveraged to improve quality of care and, in turn, treatment outcomes. This is a protocol paper that describes an innovative study design in which we rigorously evaluate the effectiveness of a tablet-assisted intervention, Supporting Providers and Reaching Kids (SPARK). SPARK consists of a collection of interactive games and activities that are designed to improve provider fidelity and child engagement in evidence-based psychotherapies. The methodology also allows us to explore the implementation and sustainability of a technology-enhanced intervention in more than two dozen community practice settings. This paper includes a description and justification for sample selection and recruitment procedures, selection of assessment measures and methods, design of the intervention, and statistical evaluation of critical outcomes. Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context. Challenges related to the implementation of a technology-enhanced intervention in existing mental health clinics are discussed, as well as implications for future research and practice.",2020,Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context.,['child mental health treatment'],['tablet-based application'],"['provider fidelity and child engagement', 'quality of care']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}]",,0.040181,Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context.,"[{'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Anton', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America. Electronic address: antonm@musc.edu.'}, {'ForeName': 'Leigh E', 'Initials': 'LE', 'LastName': 'Ridings', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Hanson', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Davidson', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'Department of Psychological Science, University of Vermont, John Dewey Hall, Rm 248, 2 Colchester Ave., Burlington, VM 05405, United States of America.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Kmett Danielson', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Chu', 'Affiliation': 'Graduate School of Applied and Professional Psychology, Rutgers University, 152 Frelinghuysen Rd., Piscataway, NJ 08854, United States of America.'}, {'ForeName': 'Clara E', 'Initials': 'CE', 'LastName': 'Dismuke', 'Affiliation': 'Health Economics Resource Center (HERC), VA Palo Alto Health Care System, 795 Willow Road (152-MPD), Menlo Park, CA 94025, United States of America.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, School of Medicine, Indiana University, 410 West 10th Street, Indianapolis, IN 46202, United States of America.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ruggiero', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106010']
156,32335900,"The impact of respiratory protective equipment on difficult airway management: a randomised, crossover, simulation study.","The current international COVID-19 health crisis underlines the importance of adequate and suitable personal protective equipment for clinical staff during acute airway management. This study compares the impacts of standard air-purifying respirators and powered air-purifying respirators during simulated difficult airway scenarios. Twenty-five anaesthetists carried out four different standardised difficult intubation drills, either unprotected (control), or wearing a standard or a powered respirator. Treatment times and wearer comfort were determined and compared. In the wearer comfort evaluation form, operators rated mobility, noise, heat, vision and speech intelligibility. All anaesthetists accomplished the treatment objectives of all study arms without adverse events. Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™; 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope; 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope; and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard tracheal intubation by direct laryngoscopy, respectively. Videolaryngoscopy allowed the shortest intubation times regardless of the respiratory protective device used. Anaesthetists rated heat and vision significantly higher in the powered respirator group; however, noise levels were perceived to be significantly lower than in the standard respirator group. We conclude that standard and powered respirators do not significantly prolong simulated advanced intubation procedures.",2020,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.",[],"['standard air purifying respirators and powered air purifying respirators', 'respiratory protective equipment', 'standardised difficult intubation drills, either unprotected (control), or wearing a standard, or a powered respirator', 'Videolaryngoscopy']","['Total mean (SD) intubation times', 'Anaesthetists rated heat and vision', 'operators rated mobility, noise, heat, vision, and speech intelligibility', 'Treatment times and wearer comfort', 'noise levels']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0549401', 'cui_str': 'Difficult intubation'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.0444717,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Arlidge', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dudley', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sicinski', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}]",Anaesthesia,['10.1111/anae.15102']
157,32278195,Cardiorespiratory responses to fine particles during ambient PM 2.5 pollution waves: Findings from a randomized crossover trial in young healthy adults.,"BACKGROUND
PM 2.5 pollution waves (PPWs) are severe air pollution events with extremely high-level concentration of ambient PM 2.5 . PPWs, such as haze days, were suggested to be associated with increased cardiopulmonary mortality and morbidity. However, the biological mechanism response to ambient PM 2.5 during PPWs is still unclear.
METHODS
A randomized crossover trial was conducted on 29 healthy young adults. Repeated health measurements were performed before, during and after two typical PPWs under filtered and sham indoor air purification, with a washout interval of at least 2 weeks. Health parameters including blood pressure (BP), pulmonary function, fractional exhaled nitric oxide (FeNO) and circulating biomarkers which reflect platelet activation, blood coagulation and systematic oxidative stress were measured.
RESULTS
Ambient PM 2.5 levels elevated apparently during PPWs. Under sham purification, significant increase in FeNO and soluble P-selectin (sP-selectin) and decreases in pulmonary function were observed from pre-PPWs period to during-PPWs period. The changes in health biomarkers as mentioned above became attenuated and insignificant under filtered condition. For instance, sP-selectin increased by 12.0% (95% CI: 3.8%, 20.8%) during-PPWs periods compared with pre-PPWs periods under sham purification, while non-significant change was observed under filtered condition. Significant associations between time-weighted personal PM 2.5 exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
CONCLUSION
PPWs could affect cardiopulmonary health through systematic oxidative stress, platelet activation and respiratory inflammation in healthy adults, and short-term indoor air purification could alleviate the adverse cardiopulmonary effects.",2020,"Significant associations between time-weighted personal PM 2.5 exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","['healthy adults', 'young healthy adults', '29 healthy young adults']",[],"['blood pressure (BP), pulmonary function, fractional exhaled nitric oxide (FeNO) and circulating biomarkers which reflect platelet activation, blood coagulation and systematic oxidative stress', 'levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α', 'FeNO and soluble P-selectin (sP-selectin', 'cardiopulmonary mortality and morbidity', 'health biomarkers', 'Cardiorespiratory responses', 'sP-selectin', 'pulmonary function']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",29.0,0.0335382,"Significant associations between time-weighted personal PM 2.5 exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Kou', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Zemin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: jing_huang@bjmu.edu.cn.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: guoxb@bjmu.edu.cn.'}]",Environment international,['10.1016/j.envint.2020.105590']
158,32305093,"Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial.","BACKGROUND
Acalabrutinib is a selective, covalent Bruton tyrosine-kinase inhibitor with activity in chronic lymphocytic leukaemia. We compare the efficacy of acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab in patients with treatment-naive chronic lymphocytic leukaemia.
METHODS
ELEVATE TN is a global, phase 3, multicentre, open-label study in patients with treatment-naive chronic lymphocytic leukaemia done at 142 academic and community hospitals in 18 countries. Eligible patients had untreated chronic lymphocytic leukaemia and were aged 65 years or older, or older than 18 years and younger than 65 years with creatinine clearance of 30-69 mL/min (calculated by use of the Cockcroft-Gault equation) or Cumulative Illness Rating Scale for Geriatrics score greater than 6. Additional criteria included an Eastern Cooperative Oncology Group performance status score of 2 or less and adequate haematologic, hepatic, and renal function. Patients with significant cardiovascular disease were excluded, and concomitant treatment with warfarin or equivalent vitamin K antagonists was prohibited. Patients were randomly assigned (1:1:1) centrally via an interactive voice or web response system to receive acalabrutinib and obinutuzumab, acalabrutinib monotherapy, or obinutuzumab and oral chlorambucil. Treatments were administered in 28-day cycles. To reduce infusion-related reactions, acalabrutinib was administered for one cycle before obinutuzumab administration. Oral acalabrutinib was administered (100 mg) twice a day until progressive disease or unacceptable toxic effects occurred. In the acalabrutinib-obinutuzumab group, intravenous obinutuzumab was given on days 1 (100 mg), 2 (900 mg), 8 (1000 mg), and 15 (1000 mg) of cycle 2 and on day 1 (1000 mg) of cycles 3-7. In the obinutuzumab-chlorambucil group, intravenous obinutuzumab was given on days 1 (100 mg), 2 (900 mg), 8 (1000 mg), and 15 (1000 mg) of cycle 1 and on day 1 (1000 mg) of cycles 2-6. Oral chlorambucil was given (0·5 mg/kg) on days 1 and 15 of each cycle, for six cycles. The primary endpoint was progression-free survival between the two combination-therapy groups, assessed by independent review committee. Crossover to acalabrutinib was allowed in patients who progressed on obinutuzumab-chlorambucil. Safety was assessed in all patients who received at least one dose of treatment. Enrolment for this trial is complete, and the study is registered at ClinicalTrials.gov, NCT02475681.
FINDINGS
Between Sept 14, 2015, and Feb 8, 2017, we recruited 675 patients for assessment. 140 patients did not meet eligibility criteria, and 535 patients were randomly assigned to treatment. 179 patients were assigned to receive acalabrutinib-obinutuzumab, 179 patients were assigned to receive acalabrutinib monotherapy, and 177 patients were assigned to receive obinutuzumab-chlorambucil. At median follow-up of 28·3 months (IQR 25·6-33·1), median progression-free survival was longer with acalabrutinib-obinutuzumab and acalabrutinib monotherapy, compared with obinutuzumab-chlorambucil (median not reached with acalabrutinib and obinutuzumab vs 22·6 months with obinutuzumab, hazard ratio [HR] 0·1; 95% CI 0·06-0·17, p<0·0001; and not reached with acalabrutinib monotherapy vs 22·6 months with obinutuzumab, 0·20; 0·13-0·3, p<0·0001). Estimated progression-free survival at 24 months was 93% with acalabrutinib-obinutuzumab (95% CI 87-96%), 87% with acalabrutinib monotherapy (81-92%), and 47% with obinutuzumab-chlorambucil (39-55%). The most common grade 3 or higher adverse event across groups was neutropenia (53 [30%] of 178 patients in the acalabrutinib-obinutuzumab group, 17 [9%] of 179 patients in the acalabrutinib group, and 70 [41%] of 169 patients in the obinutuzumab-chlorambucil group). All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients). Grade 3 or higher infections occurred in 37 (21%) patients given acalabrutinib-obinutuzumab, 25 (14%) patients given acalabrutinib monotherapy, and 14 (8%) patients given obinutuzumab-chlorambucil. Deaths occurred in eight (4%) patients given acalabrutinib-obinutuzumab, 12 (7%) patients given acalabrutinib, and 15 (9%) patients given obinutuzumab-chlorambucil.
INTERPRETATION
Acalabrutinib with or without obinutuzumab significantly improved progression-free survival over obinutuzumab-chlorambucil chemoimmunotherapy, providing a chemotherapy-free treatment option with an acceptable side-effect profile that was consistent with previous studies. These data support the use of acalabrutinib in combination with obinutuzumab or alone as a new treatment option for patients with treatment-naive symptomatic chronic lymphocytic leukaemia.
FUNDING
Acerta Pharma, a member of the AstraZeneca Group, and R35 CA198183 (to JCB).",2020,All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients).,"['Eligible patients had untreated chronic lymphocytic leukaemia and were aged 65 years or older, or older than 18 years and younger than 65 years with creatinine clearance of 30-69 mL/min (calculated by use of the Cockcroft-Gault equation) or Cumulative Illness Rating Scale for Geriatrics score greater than 6', '140 patients did not meet eligibility criteria, and 535 patients', '675 patients for assessment', 'patients with treatment-naive chronic lymphocytic leukaemia', 'Between Sept 14, 2015, and Feb 8, 2017', 'Patients with significant cardiovascular disease', 'patients who progressed on obinutuzumab-chlorambucil', ' and 177 patients', '179 patients', 'patients with treatment-naive symptomatic chronic lymphocytic leukaemia', 'treatment-naive chronic lymphocytic leukaemia (ELEVATE TN', 'Additional criteria included an Eastern Cooperative Oncology Group performance status score of 2 or less and adequate haematologic, hepatic, and renal function', 'chronic lymphocytic leukaemia', 'patients with treatment-naive chronic lymphocytic leukaemia done at 142 academic and community hospitals in 18 countries']","['acalabrutinib-obinutuzumab', 'centrally via an interactive voice or web response system to receive acalabrutinib and obinutuzumab, acalabrutinib monotherapy, or obinutuzumab and oral chlorambucil', 'intravenous obinutuzumab', 'acalabrutinib monotherapy', 'Oral chlorambucil', 'warfarin or equivalent vitamin K antagonists', 'acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab', 'Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab', 'obinutuzumab-chlorambucil chemoimmunotherapy', 'obinutuzumab', 'obinutuzumab-chlorambucil']","['Estimated progression-free survival', 'median progression-free survival', 'Deaths', 'Safety', 'Grade 3 or higher infections', 'progression-free survival', 'neutropenia']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",179.0,0.186592,All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients).,"[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': 'Willamette Valley Cancer Institute/US Oncology, Eugene, OR, USA.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Egyed', 'Affiliation': 'Department of Hematology, Somogy County Mór Kaposi General Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie National Institute of Oncology, Kraków, Poland.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Skarbnik', 'Affiliation': 'Department of Medicine, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA; Lymphoproliferative Disorders Program, Novant Health Cancer Institute, Charlotte NC, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pagel', 'Affiliation': 'Swedish Cancer Institute, Center for Blood Disorders and Stem Cell Transplantation, Seattle, WA, USA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute, Tennessee Oncology Nashville, Nashville, TN, USA.'}, {'ForeName': 'Manali', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Division of Hematology, Hematologic Malignancies and Stem Cell Transplantation, University of Colorado Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Talha', 'Initials': 'T', 'LastName': 'Munir', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's Institute of Oncology, Leeds, UK.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Walewska', 'Affiliation': 'Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Corbett', 'Affiliation': 'Department of Medicine, Tauranga Hospital, Tauranga, New Zealand.'}, {'ForeName': 'Laura Maria', 'Initials': 'LM', 'LastName': 'Fogliatto', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Herishanu', 'Affiliation': 'Department of Hematology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Banerji', 'Affiliation': 'Departments of Internal Medicine, Biochemistry & Medical Genetics, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Research Institute in Oncology and Hematology, CancerCare Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Coutre', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Follows', 'Affiliation': ""Department of Haematology, Addenbrooke's Hospital NHS Trust, Cambridge, UK.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Walker', 'Affiliation': 'Peninsula Health, and Peninsula Private Hospital, Frankston, Victoria, Australia; Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Karlsson', 'Affiliation': 'Department of Haematology, Oncology and Radiophysics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Hematology Department, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Cymbalista', 'Affiliation': 'Bobigny: Hématologie, CHU Avicennes, Bobigny, France.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Woyach', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center and Division of Hematology, Columbus, OH, USA.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': ""Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d'Hématologie Clinique, Pierre-Bénite, France.""}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Min Hui', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center and Division of Hematology, Columbus, OH, USA. Electronic address: john.byrd@osumc.edu.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30262-2']
159,32315965,Baduanjin mind-body exercise improves logical memory in long-term hospitalized patients with schizophrenia: A randomized controlled trial.,"Neurocognitive impairment is one of the core symptoms in schizophrenia and poses a great challenge to effective treatment. Sixty-one long-term hospitalized patients with schizophrenia were recruited and randomly assigned to two groups: Baduanjin exercise and brisk walking. Patients in the Baduanjin group received 24 weeks of Baduanjin training (5 days/week, 40 min/day), while patients in the brisk walking group received 24 weeks of brisk walking (5 days/week, 40 min/day). Scores on the Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale were used to evaluate the logical memory (LM), processing speed, and clinical symptoms of all participants, while the score of Trail Making Test-A (TMT-A) was applied to assess the visual attention and graphomotor speed, at baseline and the 16th week and 24th week of intervention. The one-way repeated measures analysis of variance (ANOVA) was used to test the differences in neurocognitive changes between the two groups. Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328). A significant effect of time was also detected in the LM immediate (F=10.24, p = 0.000) and LM delayed (F=4.93, p = 0.009) scores and in the completion time of the TMT-A (F=33.10, p = 0.000), but not in the DSST scores (F=2.12, p = 0.122). Baduanjin exercise could improve logical memory in the long-term hospitalized patients with schizophrenia.",2020,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","['long-term hospitalized patients with schizophrenia', 'hospitalized patients with schizophrenia', 'Sixty-one long-term hospitalized patients with schizophrenia']","['Baduanjin exercise', 'Baduanjin training', 'brisk walking group received 24 weeks of brisk walking', 'Baduanjin exercise and brisk walking', 'Baduanjin mind-body exercise']","['LM immediate', 'logical memory (LM), processing speed, and clinical symptoms', 'neurocognitive changes', 'LM delayed', 'logical memory', 'visual attention and graphomotor speed', 'completion time of the TMT-A', 'Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale', 'DSST scores']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0321369,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","[{'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Mental Health Center and Psychiatric Laboratory, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China; The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: limingli0517@qq.com.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Yusubujiang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: 577827619@qq.com.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102046']
160,32328115,"Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy.","Background
Previous proof-of-concept studies have shown that a short course of omalizumab can safely accelerate the oral immunotherapy schedule for multiple allergens simultaneously. Considering the high cost of medication, the dose-related efficacy of omalizumab at decreasing the duration of oral immunotherapy up-dosing phase must be objectively quantified before cost-benefit analyses can be performed. The primary objective of this trial will be to compare the efficacy of 2 omalizumab dosages to placebo at decreasing time-to-maintenance dose during a symptom-driven multi-food OIT protocol.
Methods
A total of 90 participants aged 6 to 25 with multiple food allergies (3 or more) will be enrolled at four sites in Canada. Participants will be randomized to: (A) Omalizumab 8 mg/kg per month (n = 36); (B) Omalizumab 16 mg/kg per month (n = 36); or (C) Placebo (n = 18). Study drug will be administered at full dosage for 12 weeks, then progressively tapered at 50% dosage (8 mg/kg vs 4 mg/kg vs placebo) for 4 weeks and at 25% dosage (4 mg/kg vs 2 mg/kg vs placebo) for another 4 weeks. After a pre-treatment period of 8 weeks, participants will undergo an initial food escalation (IFE) to an OIT mix containing 3 allergens and start daily home dosing with biweekly increases until a target daily maintenance of 1500 mg protein is achieved. The amount escalated at each visit will vary based on treatment tolerance according to a standardized up-dosing algorithm. Participants will be followed for at least 12 months following the initial food escalation. The primary endpoint will be time from IFE to the target maintenance dose of 1500 mg protein. Time-to-event analytic methods, including the log-rank test, will be used to compare the 3 arms.
Discussion
This trial uses a novel pragmatic approach to compare OIT with omalizumab to OIT without omalizumab in a blinded manner, which allows to single out the effect of this anti-IgE medication on treatment effectiveness speed without the recourse to predetermined schedules. The innovative patient-centered up-dosing algorithm allows to maximise treatment effectiveness speed without compromising patient safety, regardless of whether the patient is on omalizumab or not. This study will also provide novel prospective data to inform on the optimal and most cost-effective dosage for this indication. Trial registration ClinicalTrials.gov, NCT04045301, Registered 5 August 2019, https://clinicaltrials.gov/ct2/show/NCT04045301.",2020,"The innovative patient-centered up-dosing algorithm allows to maximise treatment effectiveness speed without compromising patient safety, regardless of whether the patient is on omalizumab or not.",['90 participants aged 6 to 25 with multiple food allergies (3 or more) will be enrolled at four sites in Canada'],"['Placebo', 'omalizumab', 'placebo', 'Omalizumab']",['time from IFE to the target maintenance dose of 1500\xa0mg protein'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",90.0,0.391398,"The innovative patient-centered up-dosing algorithm allows to maximise treatment effectiveness speed without compromising patient safety, regardless of whether the patient is on omalizumab or not.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlois', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Lavergne', 'Affiliation': '3Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Leroux', 'Affiliation': '3Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Killer', 'Affiliation': '3Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Azzano', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Paradis', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Samaan', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lacombe-Barrios', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Mâsse', 'Affiliation': '3Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Des Roches', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bégin', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}]","Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology",['10.1186/s13223-020-00419-z']
161,32330764,Preventing college student nonmedical prescription stimulant use: Development of vested interest theory-based persuasive messages.,"Vested interest theory (VIT) predicts that perceived importance and hedonic relevance of an expected behavioral outcome affects attitude-behavior consistency. Applied to college students' nonmedical use of prescription stimulants (NUPS), the theory posits that persuasive information that weakens vested perceptions regarding assumed advantages of stimulant misuse will reduce usage intentions. The current study developed and experimentally assessed persuasive messages that targeted perceptions of vested interest (VI), and examined if message effectiveness varied as a function of users' risk status. Appeals that focused on the physical harms of misuse served as the comparison condition. College student participants (N = 282) were randomly assigned to one of four message conditions. To examine group differences, data were analyzed in a 2 (VIT-based message: yes, no) × 2 (Physical harms emphasized: yes, no) × 3 (User status: resolute, vulnerable, user) between-subjects factorial design. Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005. In vulnerable nonusers, these messages also decreased NUPS intentions p = .006. The effect of exposure to the physical harm communication was not significant. Findings support the potential of VIT-guided messages in NUPS prevention, and the lack of effect of messages focused on physical consequences of misuse.",2020,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"['College student participants (N\xa0=\xa0282', 'college students']","['Vested interest theory (VIT', 'NUPS', 'nonmedical use of prescription stimulants (NUPS']",['cognitive functioning'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",282.0,0.0167375,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"[{'ForeName': 'Candice D', 'Initials': 'CD', 'LastName': 'Donaldson', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Candice.Donaldson@cgu.edu.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Jason.Siegel@cgu.edu.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Crano', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: William.Crano@cgu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106440']
162,32179149,Greater optimisation of pharmacokinetic/pharmacodynamic parameters through a loading dose of intravenous colistin in paediatric patients.,"Use of colistin in children is rising in line with the increase of multidrug-resistant Gram-negative bacteria (MDR-GNB). In adults, a colistin loading dose is recommended to achieve therapeutic concentrations within 12-24 h. Here we aimed to describe the pharmacokinetic (PK) parameters of a loading dose versus a recommended initial dose of intravenous colistimethate sodium (CMS) in paediatric patients. A prospective, open-label, PK study was conducted in paediatric patients (age 2-18 years) with normal renal function. Patients (n = 20) were randomly assigned to receive either a CMS loading dose (LD group) of 4 mg of colistin base activity (CBA)/kg/dose or a standard initial dose (NLD group) of 2.5 mg (12-h interval) or 1.7 mg (8-h interval) of CBA/kg/dose. Serial blood samples were collected. Plasma concentrations of formed colistin were measured by LC-MS/MS. PK parameters were reported. Acute kidney injury (AKI) was monitored by serum creatinine and urine NGAL. The median (interquartile range) age and body weight were 8.5 (3.5-11.3) years and 21.5 (13.5-20.0) kg. The mean (standard deviation) of first-dose PK parameters of the LD group versus the NLD group were: C max , 6.1 (2.4) vs. 4.1 (1.3) mg/L; AUC 0- t , 26.5 (12.5) vs. 13.5 (3.6) mg/L·h; V d , 0.7 (0.4) vs. 0.6 (0.3) L/kg; and t 1/2 , 2.9 (0.6) vs. 2.6 (0.4) h. No patient developed AKI by serum creatinine criteria. A CMS loading dose is beneficial for improvement of colistin exposure without increased AKI. A higher daily dose of CMS should be considered, especially for MDR-GNB treatment.",2020,"The mean (standard deviation) of first-dose PK parameters of the LD group vs the NLD group were C max 6.1 (2.4) vs 4.1 (1.3) mg/L, AUC 0-t 26.5 (12.5) vs 13.5 (3.6) mg/L*h, Vd 0.7 (0.4) vs 0.6 (0.3) L/kg, and t 1/2 2.9 (0.6) vs 2.6 (0.4) h.","['Pediatric Patients', 'pediatric patients aged 2 - 18 years with normal renal function', 'Twenty children were enrolled', 'pediatric patients']","['open-label', 'CMS', 'CMS loading dose (LD group) of 4 mg of colistin base activity (CBA)/kg/dose or standard initial dose (NLD', 'intravenous colistimethate sodium (CMS']","['Acute kidney injury (AKI', 'Plasma concentration of formed colistin', 'median (interquartile range) age and body weight']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0110462', 'cui_str': 'Colistimethate sodium'}]","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",20.0,0.0285904,"The mean (standard deviation) of first-dose PK parameters of the LD group vs the NLD group were C max 6.1 (2.4) vs 4.1 (1.3) mg/L, AUC 0-t 26.5 (12.5) vs 13.5 (3.6) mg/L*h, Vd 0.7 (0.4) vs 0.6 (0.3) L/kg, and t 1/2 2.9 (0.6) vs 2.6 (0.4) h.","[{'ForeName': 'Noppadol', 'Initials': 'N', 'LastName': 'Wacharachaisurapol', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: Noppadol.W@chula.ac.th.'}, {'ForeName': 'Chayapa', 'Initials': 'C', 'LastName': 'Phasomsap', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Warumphon', 'Initials': 'W', 'LastName': 'Sukkummee', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Weeraya', 'Initials': 'W', 'LastName': 'Phaisal', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ankanee', 'Initials': 'A', 'LastName': 'Chanakul', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Supeecha', 'Initials': 'S', 'LastName': 'Wittayalertpanya', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pajaree', 'Initials': 'P', 'LastName': 'Chariyavilaskul', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.105940']
163,32179241,Anthocyanin supplementation improves anti-oxidative and anti-inflammatory capacity in a dose-response manner in subjects with dyslipidemia.,"BACKGROUND
Anthocyanins, one of the major plant bioactive substances, possess anti-oxidative and anti-inflammatory capacity. However, their dose-response relationship has remained unclear. The present study investigated the dose-response relationship of anthocyanins with oxidative stress and inflammation in subjects with dyslipidemia.
DESIGN
and Participants: A total of 169 participants with dyslipidemia were randomly assigned to placebo (n = 43), anthocyanins 40 mg/day (n = 44), 80 mg/day (n = 40), or 320 mg/day (n = 42) groups. Urine 8-iso-prostaglandin F 2 α (8-iso-PGF 2 α ), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and serum malonaldehyde (MDA), total superoxide dismutase (T-SOD), UA (uric acid), interleukin (IL)-6, IL-10, tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP) were measured at baseline, at 6 weeks, and at 12 weeks.
RESULTS
Anthocyanin supplementation (320 mg/day) for 6 weeks significantly improved T-SOD versus baseline (P < 0.05). A slight reduction in serum IL-6, TNF-α, and urine 8-iso-PGF 2 α from the baseline was observed at 12 weeks in the group receiving 40 mg/day anthocyanins. Anthocyanins (80 mg/day) significantly reduced serum IL-6 (-20%), TNF-α (-11%) and urine 8-iso-PGF 2 α (-27%) versus baseline (P < 0.05). Moreover, 320 mg/day anthocyanin supplementation reduced serum IL-6 (-40%), TNF-α (-21%), MDA (-20%) and urine 8-iso-PGF 2 α (-37%) and 8-OHdG (-36%) than 80 mg/day and 40 mg/day anthocyanins, P value < 0.05. Anthocyanin supplementation has dose-response relationships with decreased inflammatory cytokines IL-6, TNF-α and oxidative stress biomarkers 8-iso-PGF 2 α , 8-OHdG and MDA (P for trend, <0.05). Furthermore, a strong positive correlation was observed between the changes in the urine 8-iso-PGF 2 α , 8-OHdG levels and serum IL-6 levels in subjects from anthocyanin groups after 12 weeks of treatment.
CONCLUSIONS
Supplementation of anthocyanins for 12 weeks positively improved the anti-oxidative and anti-inflammatory capacity in a dose-response manner in individuals with dyslipidemia.",2020,"Anthocyanin supplementation has dose-response relationships with decreased inflammatory cytokines IL-6, TNF-α and oxidative stress biomarkers 8-iso-PGF 2 α , 8-OHdG and MDA (P for trend, <0.05).","['subjects with dyslipidemia', '169 participants with dyslipidemia', 'individuals with dyslipidemia', 'and Participants']","['Anthocyanins', 'Anthocyanin supplementation', 'anthocyanins 40\xa0mg/day', 'placebo', 'anthocyanins']","['serum IL-6, TNF-α, and urine 8-iso-PGF 2 α', ""Urine 8-iso-prostaglandin F 2 α (8-iso-PGF 2 α ), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and serum malonaldehyde (MDA), total superoxide dismutase (T-SOD), UA (uric acid), interleukin (IL)-6, IL-10, tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP"", 'TNF-α', 'serum IL-6', 'inflammatory cytokines IL-6, TNF-α and oxidative stress biomarkers 8-iso-PGF 2 α , 8-OHdG and MDA', 'T-SOD', 'urine 8-iso-PGF 2 α , 8-OHdG levels and serum IL-6 levels', 'anti-oxidative and anti-inflammatory capacity']","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanins'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0042037'}, {'cui': 'C1528569', 'cui_str': '8-isoprostaglandin PGF2beta'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0033561', 'cui_str': 'PGF'}, {'cui': 'C0050078', 'cui_str': ""2'-deoxy-8-oxo-7,8-dihydroguanosine""}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",169.0,0.105368,"Anthocyanin supplementation has dose-response relationships with decreased inflammatory cytokines IL-6, TNF-α and oxidative stress biomarkers 8-iso-PGF 2 α , 8-OHdG and MDA (P for trend, <0.05).","[{'ForeName': 'Hanyue', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: zhanghy97@mail2.sysu.edu.cn.'}, {'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: xuzhliang3@mail2.sysu.edu.cn.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: zhaohw5@mail2.sysu.edu.cn.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: wangxu25@mail2.sysu.edu.cn.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: pangj7@mail2.sysu.edu.cn.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China. Electronic address: liqing45@mail2.sysu.edu.cn.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, Guangdong Province, PR China; Department of Nutrition, School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, Guangdong Province, PR China. Electronic address: yangyan3@mail.sysu.edu.cn.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, PR China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, Guangdong Province, PR China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, Guangdong Province, PR China. Electronic address: lingwh@mail.sysu.edu.cn.'}]",Redox biology,['10.1016/j.redox.2020.101474']
164,32244170,Endogenous in-session cortisol during exposure therapy predicts symptom improvement: Preliminary results from a scopolamine-augmentation trial.,"The purpose of this study was to explore whether individual differences in glucocorticoid concentrations were associated with symptom improvement following exposure therapy for patients with social anxiety disorder. To do this, 60 participants with social anxiety disorder completed a randomized-controlled trial of exposure therapy, where participants were randomized to receive scopolamine-augmentation or placebo during their 7 exposure sessions. Scopolamine is an antimuscarinic which blocks the effects of acetylcholine and reduces autonomic arousal. During sessions 1, 4, 7, and during the post-treatment extinction assessment, participants provided up to 16 saliva samples (4 in each session). Pre-treatment, post-treatment, and at 1-month follow-up, participants completed the Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms. Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up. The association between elevated endogenous in-session cortisol and attenuated symptom change was not moderated by scopolamine treatment condition. Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy. This is the first study, to our knowledge, to examine whether endogenous in-session cortisol concentrations predict symptom changes following exposure therapy for the treatment of social anxiety disorder. More investigation of non-invasive and reliable biological markers that explain variability in responses to effective treatments are needed.",2020,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"['patients with social anxiety disorder', 'social anxiety disorder', '60 participants with social anxiety disorder', 'Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy']","['acetylcholine', 'Scopolamine', 'scopolamine', 'scopolamine-augmentation or placebo', 'exposure therapy']","['Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms', 'symptom improvement', 'autonomic arousal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",60.0,0.01704,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"[{'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Kuhlman', 'Affiliation': 'Department of Psychological Science, University of California Irvine, Irvine, CA, 92697, United States; Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Institute for Interdisciplinary Salivary Bioscience, University of California Irvine, Irvine, CA, 92697, United States. Electronic address: krkuhl@uci.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Imbriano', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Department of Psychology, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104657']
165,32247156,Association between delirium prediction scores and days spent with delirium.,"PURPOSE
To determine the correlation and discriminative value of the E-PRE-DELIRIC and PRE-DELIRIC scores with delirium exposure to evaluate the prognostic value of both models.
METHODS
A secondary analysis of a randomized clinical trial enrolling 1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2 days. Days spent with delirium (≥1 positive CAM-ICU) or coma (≥1 RASS ≤-4) in the 28-days after ICU admission were calculated. Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium.
RESULTS
The correlation between the overall E-PRE-DELIRIC and PRE-DELIRIC scores and days spent with delirium were: R = 0.08 (P = .005) and R = 0.26 (P < .001), respectively. The correlation between both prediction scores and days spent with coma or delirium were R = 0.21 (P < .0001) and R = 0.46 (P < .0001), respectively. The highest Area Under the Receiver Operating Characteristic for both E-PRE-DELIRIC [0.57 (95% CI:0.51-0.62)] and PRE-DELIRIC [0.58 (95% CI:0.53-0.62)] was found in the long delirium exposure group.
CONCLUSION
The E-PRE-DELIRIC and PRE-DELIRIC model each poorly correlate and discriminate with days spent with delirium in the 28 days after ICU admission.",2020,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"['1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2\xa0days', 'Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium']",[],"['overall E-PRE-DELIRIC and PRE-DELIRIC scores', 'prediction scores and days spent with coma or delirium']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",1506.0,0.138306,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"[{'ForeName': 'Hidde', 'Initials': 'H', 'LastName': 'Heesakkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'School of Pharmacy, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Arjen J C', 'Initials': 'AJC', 'LastName': 'Slooter', 'Affiliation': 'Department of Intensive Care Medicine and UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van den Boogaard', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands. Electronic address: Mark.vandenBoogaard@radboudumc.nl.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.008']
166,32387012,Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in ≥56-year-olds: A Phase III randomized study.,"BACKGROUND
Invasive meningococcal disease has a high mortality rate in individuals aged ≥56 years, but no vaccine is currently licensed in the USA for this age group. This study assessed the safety and immunogenicity of an investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT) compared with a meningococcal quadrivalent polysaccharide vaccine (MPSV4) in this age group.
METHODS
This was a Phase III, modified double-blind, randomized, non-inferiority study (NCT02842866) across 35 clinical sites in the USA and Puerto Rico in individuals aged ≥56 years. A single dose of the MenACYW-TT (n = 451) or MPSV4 vaccine (n = 455) was administered on Day 0. A serum bactericidal assay with human (hSBA) and baby rabbit (rSBA) complement was used to measure antibodies against serogroups A, C, W, and Y test strains at baseline and Day 30. Safety data were collected up to six months post-vaccination.
RESULTS
The seroresponse to MenACYW-TT was non-inferior to MPSV4 for each of the serogroups (A: 58.2% vs. 42.5%; C: 77.1% vs. 49.7%; W: 62.6% vs. 44.8%, Y: 74.4% vs. 43.4%, respectively). At Day 30, participants achieving hSBA titers ≥1:8 were higher for all serogroups after MenACYW-TT vs. MPSV4 (77.4-91.7 vs. 63.1-84.2%, respectively). No safety concerns were identified for either vaccine.
CONCLUSION
MenACYW-TT was well-tolerated and immunogenic in ≥56-year-olds, offering the potential to replace MPSV4 in this age group.",2020,"The seroresponse to MenACYW-TT was non-inferior to MPSV4 for each of the serogroups (A: 58.2% vs. 42.5%; C: 77.1% vs. 49.7%; W: 62.6% vs. 44.8%, Y: 74.4% vs. 43.4%, respectively).","['≥56-year-olds', 'individuals aged ≥56\xa0years', '35 clinical sites in the USA and Puerto Rico in individuals aged ≥56\xa0years']","['quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT', 'meningococcal quadrivalent polysaccharide vaccine (MPSV4', 'investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT', 'MPSV4 vaccine', 'human (hSBA) and baby rabbit (rSBA']","['Immunogenicity and safety', 'hSBA titers ≥1:8', 'safety and immunogenicity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.257761,"The seroresponse to MenACYW-TT was non-inferior to MPSV4 for each of the serogroups (A: 58.2% vs. 42.5%; C: 77.1% vs. 49.7%; W: 62.6% vs. 44.8%, Y: 74.4% vs. 43.4%, respectively).","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Esteves-Jaramillo', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: Alex.Esteves@sanofi.com.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Koehler', 'Affiliation': 'Heartland Research Associates, LLC, Wichita, KS, USA. Electronic address: tmk@heartlandresearch.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeanfreau', 'Affiliation': 'MedPharmics LLC, Metairie, LA, USA. Electronic address: robertjeanfreau@medpharmics.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Neveu', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: david.neveu@sanofi.com.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: emilia.jordanov@sanofi.com.'}, {'ForeName': 'Mandeep', 'Initials': 'M', 'LastName': 'Singh Dhingra', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: mandeepsingh.dhingra@sanofi.com.'}]",Vaccine,['10.1016/j.vaccine.2020.04.067']
167,32387014,[Repurposing of chlorpromazine in COVID-19 treatment: the reCoVery study].,"OBJECTIVES
The ongoing COVID-19 pandemic comprises a total of more than 2,350,000 cases and 160,000 deaths. The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking. Urgent action is needed to fight this fatal coronavirus infection by reducing the number of infected people along with the infection contagiousness and severity. Since the beginning of the COVID-19 outbreak several weeks ago, we observe in GHU PARIS Psychiatrie & Neurosciences (Sainte-Anne hospital, Paris, France) a lower prevalence of symptomatic and severe forms of COVID-19 infections in psychiatric patients (∼4%) compared to health care professionals (∼14%). Similar observations have been noted in other psychiatric units in France and abroad. Our hypothesis is that psychiatric patients could be protected from severe forms of COVID-19 by their psychotropic treatments. Chlorpromazine (CPZ) is a phenothiazine derivative widely used in clinical routine in the treatment of acute and chronic psychoses. This first antipsychotic medication has been discovered in 1952 by Jean Delay and Pierre Deniker at Sainte-Anne hospital. In addition, to its antipsychotic effects, several in vitro studies have also demonstrated a CPZ antiviral activity via the inhibition of clathrin-mediated endocytosis. Recently, independent studies revealed that CPZ is an anti-MERS-CoV and an anti-SARS-CoV-1 drug. In comparison to other antiviral drugs, the main advantages of CPZ lie in its biodistribution: (i) preclinical and clinical studies have reported a high CPZ concentration in the lungs (20-200 times higher than in plasma), which is critical because of the respiratory tropism of SARS-CoV-2; (ii) CPZ is highly concentrated in saliva (30-100 times higher than in plasma) and could therefore reduce the contagiousness of COVID-19; (iii) CPZ can cross the blood-brain barrier and could therefore prevent the neurological forms of COVID-19.
METHODS
Our hypothesis is that CPZ could decrease the unfavorable evolution of COVID-19 infection in oxygen-requiring patients without the need for intensive care, but also reduce the contagiousness of SARS-CoV-2. At this end, we designed a pilot, phase III, multicenter, single blind, randomized controlled clinical trial. Efficacy of CPZ will be assessed according to clinical, biological and radiological criteria. The main objective is to demonstrate a shorter time to response (TTR) to treatment in the CPZ+standard-of-care (CPZ+SOC) group, compared to the SOC group. Response to treatment is defined by a reduction of at least one level of severity on the WHO-Ordinal Scale for Clinical Improvement (WHO-OSCI). The secondary objectives are to demonstrate in the CPZ+SOC group, compared to the SOC group: (A) superior clinical improvement; (B) a greater decrease in the biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia); (D) a greater decrease in parenchymal involvement (chest CT) on the seventh day post-randomization; (E) to define the optimal dosage of CPZ and its tolerance; (F) to evaluate the biological parameters of response to treatment, in particular the involvement of inflammatory cytokines. Patient recruitment along with the main and secondary objectives are in line with WHO 2020 COVID-19 guidelines.
CONCLUSION
This repositioning of CPZ as an anti-SARS-CoV-2 drug offers an alternative and rapid strategy to alleviate the virus propagation and the infection severity and lethality. This CPZ repositioning strategy also avoids numerous developmental and experimental steps and can save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easy to manage side effects. Indeed, CPZ is an FDA-approved drug with an excellent tolerance profile, prescribed for around 70 years in psychiatry but also in clinical routine in nausea and vomiting of pregnancy, in advanced cancer and also to treat headaches in various neurological conditions. The broad spectrum of CPZ treatment - including antipsychotic, anxiolytic, antiemetic, antiviral, immunomodulatory effects along with inhibition of clathrin-mediated endocytosis and modulation of blood-brain barrier - is in line with the historical French commercial name for CPZ, i.e. LARGACTIL, chosen as a reference to its ""LARGe ACTion"" properties. The discovery of those CPZ properties, as for many other molecules in psychiatry, is both the result of serendipity and careful clinical observations. Using this approach, the field of mental illness could provide innovative therapeutic approaches to fight SARS-CoV-2.",2020,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,['psychiatric patients'],"['Chlorpromazine (CPZ', 'CPZ', 'chlorpromazine', 'phenothiazine derivative']","['biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia', 'parenchymal involvement (chest CT', 'shorter time to response (TTR']","[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}]","[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0622901,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France. Electronic address: m.plaze@ghu-paris.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Physics for medicine Paris, Inserm, ESPCI Paris, CNRS, PSL Research university, université Paris Diderot, Sorbonne Paris Cite, Paris, France.'}, {'ForeName': 'A-C', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 evolutionary genomics of RNA viruses, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': ""Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France; Université de Paris, Laboratoire de Psychologie du développement et de l'Éducation de l'Enfant, CNRS, Paris, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France; GHU PARIS Psychiatrie et Neurosciences, site Sainte-Anne, service de Neuropathologie, Paris, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.04.010']
168,32387091,The clinical utility of apoB versus LDL-C/non-HDL-C.,"BACKGROUND
The ESC/EAS Guidelines and the EAS/EFLM consensus reports state that apoB is a more accurate marker of cardiovascular risk than LDL-C or non-HDL-C and that apoB can be measured accurately and precisely than LDL-C or non-HDL-C. Nevertheless, EAS/EFLM called for a randomized clinical trial and a cost-effective analysis before widespread implementation of apoB.
OBJECTIVE
To analyse these issues from the perspective of clinical utility as clinical utility would be considered by an informed patient and physician.
METHODS AND RESULTS
We highlight the biological inaccuracies as well as the laboratory inaccuracies of LDL-C/non-HDL-C versus apoB. We demonstrate why the biological variance in the cholesterol loading per apoB particle makes it impossible to design a randomized clinical trial to compare apoB to LDL-C/non-HDL-C. We further demonstrate that even in the context of the United States, adding apoB to a lipid panel would have only a trivial effect on costs.
CONCLUSION
We submit that no informed patient or physician would choose a less accurate test over a more accurate test if the more accurate test added only trivially to the total cost of care. For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",2020,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",[],['apoB versus LDL-C/non-HDL-C'],[],[],"[{'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",[],,0.0221709,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.","[{'ForeName': 'Ciaran N', 'Initials': 'CN', 'LastName': 'Kohli-Lynch', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA; Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thanassoulis', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Sniderman', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada. Electronic address: allansniderman@hotmail.com.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.05.001']
169,32387531,The effect of presenting relative calorie information on calories ordered.,"In this research, we tested the effect of a novel method of presenting calorie information-highlighting relative differences in calories among ingredients. We conducted an online hypothetical food choice experiment where 633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables. Each participant was randomly assigned to one of four calorie information conditions: 1) a condition in which no information about calories was provided, 2) a condition in which calorie information was provided for each ingredient, 3) a condition in which calorie information was presented relative to the highest calorie item, and 4) a condition in which calorie information was presented relative to the lowest calorie item. Participants in the high- and low-calorie reference conditions ordered between 32 and 36 fewer calories per sandwich than participants in the no-calorie information control condition (p ≤ 0.04). Calories ordered by participants in the per-item calorie condition were not significantly different than the control. Presenting relative calorie or other nutritional information to make health-related trade-offs more salient may guide consumers to make healthier choices.",2020,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"['633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables']","['condition in which no information about calories was provided, 2) a condition in which calorie information']",[],"[{'cui': 'C4543503', 'cui_str': 'Sandwich'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",[],633.0,0.0417974,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gustafson', 'Affiliation': 'Department of Agricultural Economics, University of Nebraska-Lincoln, 314A Filley Hall, Lincoln, NE, 68583, USA. Electronic address: cgustafson6@unl.edu.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Zeballos', 'Affiliation': 'USDA Economic Research Service, Food Economic Division, Washington, D.C, USA. Electronic address: eliana.zeballos@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104727']
170,32289353,Risk of contamination when planning psychological therapy trials can be assessed using a simple framework.,"OBJECTIVES
The objective of this study was to develop and pilot a standard framework that could be used to assess risk of contamination in psychological therapy trials, at the protocol development stage.
STUDY DESIGN AND SETTING
We developed and piloted a risk of contamination framework on a sample of 100 psychological therapy trial protocols registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry (www.isrctn.com). We assessed all protocols as being low or high risk via three possible sources of contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm.
RESULTS
Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%). We identified 14 studies that had a potentially high risk for contamination. Most of these (N = 10) were identified as risk of contamination arising from a therapist in the intervention arm.
CONCLUSION
The risk of contamination framework we piloted in this study could be a helpful tool for researchers aiming to identify and manage risk of contamination in their trial protocol development. We found that the risk of contamination was relatively low in the psychological therapy trials we sampled for this study, as measured by our framework, and could usually be mitigated through reasonable adjustments to the study design.",2020,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","['contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm']",[],['risk of contamination'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}]",10.0,0.109149,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': ""Department of Psychology, University of Bath, Bath BA2 7AY; King's College London, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London SE5 8AF. Electronic address: p.c.jacobsen@bath.ac.uk.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Acute and Rehabilitation Directorate Psychology Team, North East London NHS Foundation Trust, Goodmayes Hospital, Barley Lane, Ilford IG3 8XJ; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road W1T 7DN.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.04.005']
171,32388179,Do menopausal status and APOE4 genotype alter the long-term effects of intensive lifestyle intervention on cognitive function in women with type 2 diabetes mellitus?,"In the Look AHEAD trial, randomization to Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE) did not result in differences in cognitive outcomes. However, menopause and APOE genotype are factors that affect the response to this intervention. The effect of this intervention on a single cognitive assessment was examined in 3 groups of women: premenopausal or <5 years postmenopausal (N = 594), within 5-10 years (n = 388), and ≥10 years postmenopausal (n = 963), and as a function of continuous years since menopause. The late postmenopausal group in the ILI had worse composite z-scores compared to those in the DSE, whereas the younger premenopausal or early postmenopausal women in the ILI had better composite z-scores than the DSE. A significant interaction between years since menopause and intervention arm, but not baseline age, was observed on executive function domains. ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause. These findings emphasize the importance of assessing menopause and APOE status to understand how weight loss impacts cognition.",2020,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"['women with type 2 diabetes mellitus', '3 groups of women: premenopausal or <5\xa0years postmenopausal (N\xa0= 594), within 5-10\xa0years (n\xa0= 388), and ≥10\xa0years postmenopausal (n\xa0= 963), and as a function of continuous years since menopause']","['Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE', 'intensive lifestyle intervention']","['cognitive function', 'composite z-scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.020602,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"[{'ForeName': 'Hussein N', 'Initials': 'HN', 'LastName': 'Yassine', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address: hyassine@usc.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Brinton', 'Affiliation': 'Departments of Pharmacology and Neurology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Carmichael', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Hoscheidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Hugenschmidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Keller', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}]",Neurobiology of aging,['10.1016/j.neurobiolaging.2020.03.020']
172,32388198,Cost-Effectiveness Analysis of Xpert MTB/RIF for Multi-Outcomes of Patients With Presumptive Pulmonary Tuberculosis in Thailand.,"OBJECTIVES
The cost-effectiveness of screening adult patients for pulmonary tuberculosis is not clear. As such, this study aims to identify the cost-effectiveness between the Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear. Multi-outcomes were correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs).
METHODS
A decision tree model was constructed to reveal a possible clinical pathway of tuberculosis diagnosis. The researchers used a clinical study to establish the probability of all clinical pathways for input into this model. The sample size was calculated following the correct diagnosis. Participants were randomly divided into 2 groups. A structural questionnaire and the Thai version of quality of life (EQ-5D-5L) were used for interviewing.
RESULTS
The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear. Both the correct diagnosis and QALYs of the base case analysis presented the Xpert MTB/RIF method as dominant. A Monte Carlo model, which analyzed the Xpert MTB/RIF method, revealed that the average number of patients who were correctly diagnosed was 673, the QALYs were 945.85 years, and the total cost was $143 110.64. For the sputum AFB smear method, the average number who received a correct diagnosis was 592, the QALYs were 940.40 years, and the total cost was $196 666.84. Probabilistic and one-way sensitivity analysis confirmed that the Xpert MTB/RIF remained dominant.
CONCLUSIONS
These results provide useful information for the National Strategic Plan to screen all adult patients for pulmonary tuberculosis.",2020,The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear.,"['Presumptive Pulmonary Tuberculosis Patients in Thailand', 'adult patients for pulmonary tuberculosis']","['Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear', 'Xpert MTB/RIF']","['total cost', 'correct diagnosis', 'quality of life (EQ-5D-5L', 'cost-effectiveness', 'correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs']","[{'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1318720', 'cui_str': 'Acid fast stain'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0222549,The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear.,"[{'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Khumsri', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand; Department of Preventive and Social Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Piya', 'Initials': 'P', 'LastName': 'Hanvoravongchai', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand; Thailand Research Center for Health Services System, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Narin', 'Initials': 'N', 'LastName': 'Hiransuthikul', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand. Electronic address: nhiransu@yahoo.com.'}, {'ForeName': 'Charoen', 'Initials': 'C', 'LastName': 'Chuchottaworn', 'Affiliation': 'Department of Medical Services, Central Chest Institute of Thailand, Ministry of Public Health, Nonthaburi, Thailand.'}]",Value in health regional issues,['10.1016/j.vhri.2019.09.010']
173,32388274,Effects of seafood consumption on mercury exposure in Norwegian pregnant women: A randomized controlled trial.,"BACKGROUND
Seafood provides nutrients that are important for optimal development of the unborn child. However, seafood is also a source of contaminants including mercury (Hg) and methylmercury (MeHg) that may have adverse effects on neurodevelopment of the fetus. Humans are predominantly exposed to MeHg through seafood consumption, however, levels of MeHg vary considerably between species.
OBJECTIVES
Investigate, in a randomized controlled trial (RCT) during pregnancy, if an increased intake of Atlantic cod (Gadus morhua), a fish species with relatively low levels of MeHg contamination, influences total hair Hg (THHg) concentrations in humans.
METHODS
Pregnant women (n = 137) were enrolled in the RCT ""Mommy's Food"" (2016-2017), which was designed to increase iodine status. Participants were randomly assigned to intervention (400 g of cod fillets per week) or control (continued habitual diet) groups for 16 weeks (gestational week 20-36). THHg concentrations were measured at baseline and post-intervention using thermal decomposition, amalgamation, and atomic absorption spectrophotometry (US EPA method 7473). The trial is registered in ClinicalTrials.gov, NCT02610959.
RESULTS
Post-intervention, the intervention group had median (inter-quartile range) THHg concentrations of 554 (392-805) µg/kg, and the control group 485 (341-740) µg/kg (p = 0.186). When adjusting for baseline THHg concentrations, there was a significant difference between the groups in those participants with baseline THHg concentrations below 534 µg/kg. Post-intervention, 8% of the study population exceeded the US EPA reference dose in hair (1,000 µg/kg) (intervention group: n = 6, control group: n = 4).
CONCLUSION
THHg concentrations were generally low in both study groups of pregnant women, despite the relatively high seafood intake. While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.",2020,"While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.","['Pregnant women (n\u202f=\u202f137', 'Norwegian pregnant women', 'humans']","['RCT', 'seafood consumption', 'intervention (400\xa0g of cod fillets per week) or control (continued habitual diet']","['total hair Hg (THHg) concentrations', 'iodine status', 'THHg concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0184934', 'cui_str': 'Filleting'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",7473.0,0.204374,"While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.","[{'ForeName': 'Synnøve', 'Initials': 'S', 'LastName': 'Næss', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway. Electronic address: synnoeve.naess@hi.no.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Kjellevold', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Ive', 'Initials': 'I', 'LastName': 'Nerhus', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Lisa Kolden', 'Initials': 'LK', 'LastName': 'Midtbø', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Bank', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway; University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Josef D', 'Initials': 'JD', 'LastName': 'Rasinger', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Maria Wik', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}]",Environment international,['10.1016/j.envint.2020.105759']
174,32389606,Patient-Reported Receipt of Goal-Concordant Care Among Seriously Ill Outpatients-Prevalence and Associated Factors.,"CONTEXT
Goal-concordant care is an important indicator of high-quality care in serious illness.
OBJECTIVES
To estimate the prevalence of patient-reported receipt of goal-concordant care among seriously ill outpatients and identify factors associated with the absence of patient-reported goal concordance.
METHODS
Analysis of enrollment surveys from a multicenter cluster-randomized trial of outpatients with serious illness. Patients reported their prioritized health care goal and the focus of their current medical care; these items were matched to define receipt of goal-concordant care.
RESULTS
Of 405 patients with a prioritized health care goal, 58% reported receipt of goal-concordant care, 17% goal-discordant care, and 25% were uncertain of the focus of their care. Patient-reported receipt of goal concordance differed by patient goal. For patients who prioritized extending life, 86% reported goal-concordant care, 2% goal-discordant care, and 12% were uncertain of the focus of their care. For patients who prioritized relief of pain and discomfort, 51% reported goal-concordant care, 21% goal-discordant care, and 28% were uncertain of the focus of their care. Patients who prioritized a goal of relief of pain and discomfort were more likely to report goal-discordant care than patients who prioritized a goal of extending life (relative risk ratio 22.20; 95% CI 4.59, 107.38).
CONCLUSION
Seriously ill outpatients who prioritize a goal of relief of pain and discomfort are less likely to report receipt of goal-concordant care than patients who prioritize extending life. Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.",2020,Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.,"['patients who prioritize relief of pain and discomfort and promoting care aligned with that goal', 'Analysis of enrollment surveys from a multi-center cluster-randomized trial of outpatients with serious illness', '405 patients with a prioritized healthcare goal']",[],['pain and discomfort'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",405.0,0.0464339,Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.,"[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Modes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA. Electronic address: modes@uw.edu.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Heckbert', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Engelberg', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Nielsen', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA; Department of Bioethics and Humanities, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Kross', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.04.026']
175,32390133,Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis.,"BACKGROUND
Malnutrition is common in patients with chronic kidney disease (CKD) on dialysis. Oral protein-based nutritional supplements are often provided to patients whose oral intake is otherwise insufficient to meet their energy and protein needs. Evidence for the effectiveness of oral protein-based nutritional supplements in this population is limited.
OBJECTIVES
The aims of this review were to determine the benefits and harms of using oral protein-based nutritional supplements to improve the nutritional state of patients with CKD requiring dialysis.
SEARCH METHODS
We searched the Cochrane Kidney and Transplant Register of Studies up to 12 December 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of patients with CKD requiring dialysis that compared oral protein-based nutritional supplements to no oral protein-based nutritional supplements or placebo.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed studies for eligibility, risk of bias, and extracted data from individual studies. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference and 95% CI for continuous outcomes.
MAIN RESULTS
Twenty-two studies (1278 participants) were included in this review. All participants were adults on maintenance dialysis of whom 79% were on haemodialysis (HD) and 21% peritoneal dialysis. The follow-up period ranged from one to 12 months. The majority of studies were at unclear risk of selection, performance, and reporting bias. The detection bias was high for self-reported outcomes. Oral protein-based nutritional supplements probably lead to a higher mean change in serum albumin compared to the control group (16 studies, 790 participants: MD 0.19 g/dL, 95% CI 0.05 to 0.33; moderate certainty evidence), although there was considerable heterogeneity in the combined analysis (I 2 = 84%). The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect). Oral protein-based nutritional supplements also probably leads to a higher mean serum albumin at the end of the intervention (14 studies, 715 participants: MD 0.14 g/dL, 95% CI 0 to 0.27; moderate certainty evidence), however heterogeneity was again high (I 2 = 80%). Again the increase was more evident in HD participants (9 studies, 498 participants: MD 0.21 g/dL, 95% CI 0.03 to 0.38; P = 0.02 for overall effect) and malnourished participants (7 studies, 377 participants: MD 0.25 g/dL, 95% CI 0.02 to 0.47; P = 0.03 for overall effect). Compared to placebo or no supplement, low certainty evidence showed oral protein-based nutritional supplements may result in a higher serum prealbumin (4 studies, 225 participants: MD 2.81 mg/dL, 95% CI 2.19 to 3.43), and mid-arm muscle circumference (4 studies, 216 participants: MD 1.33 cm, 95% CI 0.24 to 2.43) at the end of the intervention. Compared to placebo or no supplement, oral protein-based nutritional supplements may make little or no difference to weight (8 studies, 365 participants: MD 2.83 kg, 95% CI -0.43 to 6.09; low certainty evidence), body mass index (9 studies, 368 participants: MD -0.04 kg/m 2 , 95% CI -0.74 to 0.66; moderate certainty evidence) and lean mass (5 studies, 189 participants: MD 1.27 kg, 95% CI -1.61 to 4.51; low certainty evidence). Due to very low quality of evidence, it is uncertain whether oral protein-based nutritional supplements affect triceps skinfold thickness, mid-arm circumference, C-reactive protein, Interleukin 6, serum potassium, or serum phosphate. There may be little or no difference in the risk of developing gastrointestinal intolerance between participants who received oral protein-based nutritional supplements compared with placebo or no supplement (6 studies, 426 participants: RR 2.81, 95% CI 0.58 to 13.65, low certainty evidence). It was not possible to draw conclusions about cost or quality of life, and deaths were not reported as a study outcome in any of the included studies.
AUTHORS' CONCLUSIONS
Overall, it is likely that oral protein-based nutritional supplements increase both mean change in serum albumin and serum albumin at end of intervention and may improve serum prealbumin and mid-arm muscle circumference. The improvement in serum albumin was more evident in haemodialysis and malnourished participants. However, it remains uncertain whether these results translate to improvement in nutritional status and clinically relevant outcomes such as death. Large well-designed RCTs in this population are required.",2020,"The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect).","['patients with CKD requiring dialysis', 'Twenty-two studies (1278 participants', 'patients with CKD requiring dialysis that compared', '365 participants: MD 2.83 kg, 95% CI -0.43 to 6.09; low certainty evidence), body mass index (9 studies, 368 participants', 'people with chronic kidney disease requiring dialysis', 'All participants were adults on maintenance dialysis of whom 79% were on haemodialysis (HD) and 21% peritoneal dialysis', 'patients with chronic kidney disease (CKD) on dialysis']","['Oral protein-based nutritional supplements', 'placebo or no supplement, oral protein-based nutritional supplements', 'Oral protein-based supplements versus placebo', 'oral protein-based nutritional supplements', 'oral protein-based nutritional supplements to no oral protein-based nutritional supplements or placebo', 'placebo']","['serum albumin', 'moderate certainty evidence) and lean mass', 'serum prealbumin and mid-arm muscle circumference', 'cost or quality of life, and deaths', 'mean serum albumin', 'serum albumin and serum albumin', 'risk of developing gastrointestinal intolerance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0562347', 'cui_str': 'Mid arm muscle circumference'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}]",,0.257445,"The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect).","[{'ForeName': 'Jia Yee', 'Initials': 'JY', 'LastName': 'Mah', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Suet Wan', 'Initials': 'SW', 'LastName': 'Choy', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Roberts', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Desai', 'Affiliation': 'Department of Dietetics/Renal, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Corken', 'Affiliation': 'Department of Dietetics/Renal, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Gwini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Clayton, Australia.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'McMahon', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012616.pub2']
176,32393980,Afternoon distraction: a high-saturated-fat meal and endotoxemia impact postmeal attention in a randomized crossover trial.,"BACKGROUND
Saturated-fat intake and endotoxemia can impair cognition. However, their acute impact on cognitive performance is unknown.
OBJECTIVE
This study assessed the impact of 2 high-fat meals and endotoxemia on attention.
METHODS
In this double-blind, randomized crossover trial, 51 women (n = 32 breast cancer survivors, n = 19 noncancer controls; mean ± SD age: 53 ± 8 y) completed the Continuous Performance Test (CPT) and had their blood drawn to assess endotoxemia markers LPS binding protein (LBP), soluble CD14 (sCD14), and the LBP to sCD14 ratio 1 h prior to eating either a high-saturated-fat meal or a high-oleic-sunflower-oil meal. Women again completed the CPT 5 h postmeal. At 1 to 4 wk later, women completed the same protocol but consumed the other meal.
RESULTS
In adjusted models, women had more difficulty distinguishing target stimuli from distractors after consuming the high-saturated-fat meal than they did after the oleic-sunflower-oil meal (B = 4.44, SE = 1.88, P = 0.02). Women with higher baseline LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04). Those with higher LBP and LBP:sCD14 were less able to sustain their attention throughout the entire CPT, as reflected by their progressively slower (B = 0.002, SE = 0.0006, P = 0.003; and B = 2.43, SE = 0.090, P = 0.008, respectively) and more erratic (B = 0.003, SE = 0.0008, P < 0.0001; and B = 3.29, SE = 1.17, P = 0.006, respectively) response times. Additionally, women with higher baseline LBP or sCD14 were less able to maintain or increase response speeds at higher interstimulus intervals (B = 0.002, SE = 0.0006, P = 0.02; and B = 0.006, SE = 0.003, P = 0.03, respectively), indicating greater difficulty adapting to changing task demands. Significant meal type by LBP and LBP:sCD14 interactions emerged (P < 0.05), such that high LBP and LBP:sCD14 erased between-meal cognitive differences, uniformly impairing performance.
CONCLUSIONS
These results suggest that higher LBP, sCD14, and LBP:sCD14 and saturated-fat intake individually and jointly influence attention. Endotoxemia may override the relative cognitive benefit of healthier oil choices.This trial is registered at clinicaltrials.gov as NCT04247763.",2020,"LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04).","['Women with higher baseline', '51 women (n\xa0=\xa032 breast cancer survivors, n\xa0=\xa019 noncancer controls; mean ± SD age: 53 ± 8 y']","['Afternoon distraction', 'LBP', 'Continuous Performance Test (CPT', 'LBP to sCD14 ratio 1 h prior to eating either a high-saturated-fat meal or a high-oleic-sunflower-oil meal']","['endotoxemia markers LPS binding protein (LBP), soluble CD14 (sCD14', 'cognitive performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0376618', 'cui_str': 'Endotoxemia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}]",51.0,0.151899,"LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04).","[{'ForeName': 'Annelise A', 'Initials': 'AA', 'LastName': 'Madison', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Belury', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Andridge', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'M Rosie', 'Initials': 'MR', 'LastName': 'Shrout', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Renna', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Malarkey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Bailey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Janice K', 'Initials': 'JK', 'LastName': 'Kiecolt-Glaser', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa085']
177,32395750,To trigger or not to trigger ovulation in a natural cycle for frozen embryo transfer: a randomized controlled trial.,"STUDY QUESTION
Is the clinical pregnancy rate (CPR) following a frozen embryo transfer (FET) in a natural cycle (NC) higher after spontaneous ovulation than after triggered ovulation [natural cycle frozen embryo transfer (NC-FET) versus modified NC-FET]?
SUMMARY ANSWER
The CPR did not vary significantly between the two FET preparation protocols.
WHAT IS KNOWN ALREADY
Although the use of FET is continuously increasing, the most optimal endometrial preparation protocol is still under debate. For transfer in the NC specifically, conflicting results have been reported in terms of the outcome following spontaneous or triggered ovulation.
STUDY DESIGN, SIZE, DURATION
In a tertiary hospital setting, subjects were randomized with a 1:1 allocation into two groups between January 2014 and January 2019. Patients in group A underwent an NC-FET, while in group B, a modified NC-FET was performed with a subcutaneous hCG injection to trigger ovulation. In neither group was additional luteal phase support administered. All embryos were vitrified-warmed on Day 3 and transferred on Day 4 of embryonic development. The primary outcome was CPR at 7 weeks. All patients were followed further until 10 weeks of gestation when the ongoing pregnancy rate (OPR) was defined by the observation of foetal cardiac activity on ultrasound scan. Other secondary outcomes included biochemical pregnancy rate, early pregnancy loss and the number of visits, blood samples and ultrasonographic examinations prior to FET.
PARTICIPANTS/MATERIALS, SETTING, METHODS
A total of 260 patients (130 per study arm) were randomized, of whom 12 withdrew consent after study arm allocation. A total of 3 women conceived spontaneously before initiating the study cycle and 16 did not start for personal or medical reasons. Of the 229 actually commencing monitoring for the study FET cycle, 7 patients needed to be switched to a hormonal replacement treatment protocol due to the absence of follicular development, 12 had no embryo available for transfer after warming and 37 had a spontaneous LH surge before the ovulation trigger could be administered, although they were allocated to group B. Given the above, an intention-to-treat (ITT) analysis was performed taking into account 248 patients (125 in group A and 123 in group B), as well as a per protocol (PP) analysis on a subset of 173 patients (110 in group A and 63 in group B).
MAIN RESULTS AND THE ROLE OF CHANCE
Demographic features were evenly distributed between the study groups, as were the relevant fresh and frozen ET cycle characteristics. According to the ITT analysis, the CPR and OPR in group A (33.6% and 27.2%, respectively) and group B (29.3% and 24.4%, respectively) did not vary significantly [relative risk (RR) 0.87, 95% CI (0.60;1.26), P = 0.46 and RR 0.90, 95% CI (0.59;1.37), P = 0.61, respectively]. Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups. In contrast, more clinic visits and blood samplings for cycle monitoring were required in the NC-FET group (4.05 ± 1.39) compared with the modified NC-FET group (3.03 ± 1.16, P = <0.001), while the number of ultrasound scans performed were comparable (1.70 ± 0.88 in group A versus 1.62 ± 1.04 in group B). The additional PP analysis was in line with the ITT results: CPR in group A was 36.4% versus 38.1% in group B [RR 1.05, 95% CI (0.70;1.56), P = 0.82].
LIMITATIONS, REASONS FOR CAUTION
The results are limited by the high drop-out rate for the PP analysis in the modified NC-FET group as more than one-third of the subjects allocated to this group ovulated spontaneously before ovulation triggering. Nonetheless, this issue is inherent to routine clinical practice and is an important observation of an event that can only be avoided by performing a very extensive monitoring that limits the practical advantages associated with modified NC-FET. Furthermore, although this is the largest randomized controlled trial (RCT) investigating this specific research question so far, a higher sample size would allow smaller differences in clinical outcome to be detected, since currently they may be left undetected.
WIDER IMPLICATIONS OF THE FINDINGS
This RCT adds new high-quality evidence to the existing controversial literature concerning the performance of NC-FET versus modified NC-FET. Based on our results showing no statistically significant differences in clinical outcomes between the protocols, the treatment choice may be made according to the patient's and treating physician's preferences. However, the modified NC-FET strategy reduces the need for hormonal monitoring and may therefore be considered a more patient-friendly and potentially cost-effective approach.
STUDY FUNDING/COMPETING INTEREST(S)
No specific funding was available for this study. None of the authors have a conflict of interest to declare with regard to this study.
TRIAL REGISTRATION NUMBER
NCT02145819.
TRIAL REGISTRATION DATE
8 January 2014.
DATE OF FIRST PATIENT’S ENROLMENT
21 January 2014.",2020,Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups.,"['’S ENROLMENT\n\n\n21 January 2014', '3 women conceived spontaneously before initiating the study cycle and 16 did not start for personal or medical reasons', '7 patients needed to be switched to a hormonal replacement treatment protocol due to the absence of follicular development, 12 had no embryo available for transfer after warming and 37 had a', '260 patients (130 per study arm']","['FET', 'triggered ovulation [natural cycle frozen embryo transfer (NC-FET) versus modified NC-FET', 'NC-FET', 'frozen embryo transfer (FET']","['clinical pregnancy rate (CPR', 'biochemical pregnancy rate, early pregnancy loss and the number of visits, blood samples and ultrasonographic examinations prior to FET', 'CPR', 'pregnancy rate (OPR', 'spontaneous LH surge', 'Biochemical pregnancy rate and early pregnancy loss', 'clinic visits and blood samplings for cycle monitoring', 'number of ultrasound scans']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",3.0,0.159805,Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stubbe', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santos-Ribeiro', 'Affiliation': 'Valencian Institute of Infertility Reproductive Medicine Associates (IVI-RMA) Lisboa, Avenida Infante Dom Henrique 333 H 1-9, 1800-282 Lisbon, Portugal.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Van Landuyt', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Racca', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roelens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Camus', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Vos', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van de Vijver', 'Affiliation': 'Fertiliteit, AZ Sint-Jan, Ruddershove 10, 8000 Brugge, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blockeel', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa026']
178,32406284,Prophylaxis of Radiation-Induced Dermatitis in Patients With Breast Cancer Using Herbal Creams: A Prospective Randomized Controlled Trial.,"Radiation-induced toxicity is a major limiting factor for prescribing radiation dose in cancer radiotherapy. Skin reaction to radiation is one of the primary concerns, which could affect quality of life of the patients both physically and mentally. Reviews of the literature show limited number of effective reagents for its prophylaxis. In this study, we attempted to determine whether prophylactic treatment of the 3 different herbal creams containing Centella asiatica , Cucumis sativus , and Thunbergia laurifolia extracts as well as a commercial moisturizing cream could reduce acute skin reaction in breast cancer patients undergoing radiotherapy. A total of 153 breast cancer patients undergoing radiotherapy were randomly assigned into 5 different groups with one group receiving no treatment. The patients were instructed to apply their designated creams once daily from their first radiotherapy session until 1-month post-irradiation. Their skins were graded by a radiation oncologist on a weekly basis until 1-month post-irradiation to identify any skin reactions. The results showed that the administration of the herbal creams or the moisturizing cream could neither reduce the severity nor delay the onset of dermatitis compared with the no treatment group. However, despite the limited benefits from the prophylaxis, the Cucumis sativus cream was shown to help with the skin recovery post-irradiation. These results suggested that breast cancer patients undergoing radiotherapy should be advised to apply moisturizing cream to the area of irradiated skin.",2020,The results showed that the administration of the herbal creams or the moisturizing cream could neither reduce the severity nor delay the onset of dermatitis compared with the no treatment group.,"['breast cancer patients undergoing radiotherapy', '153 breast cancer patients undergoing', 'Patients', 'breast cancer patients undergoing']","['Herbal Creams', 'moisturizing cream', 'radiotherapy']","['acute skin reaction', 'severity nor delay the onset of dermatitis']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}]",153.0,0.0204777,The results showed that the administration of the herbal creams or the moisturizing cream could neither reduce the severity nor delay the onset of dermatitis compared with the no treatment group.,"[{'ForeName': 'Saengrawee', 'Initials': 'S', 'LastName': 'Thanthong', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Rattanaporn', 'Initials': 'R', 'LastName': 'Nanthong', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Sirikorn', 'Initials': 'S', 'LastName': 'Kongwattanakul', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Kanyanee', 'Initials': 'K', 'LastName': 'Laebua', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Pornwaree', 'Initials': 'P', 'LastName': 'Trirussapanich', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Supaporn', 'Initials': 'S', 'LastName': 'Pitiporn', 'Affiliation': 'Chaopraya Abhaibhubejhr Hospital; Chaopraya Abhaiphubejhr Hospital Foundation, Prachinburi, Thailand.'}, {'ForeName': 'Danupon', 'Initials': 'D', 'LastName': 'Nantajit', 'Affiliation': 'HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.'}]",Integrative cancer therapies,['10.1177/1534735420920714']
179,32399130,A Clinical Randomized Controlled Trial of Acupuncture Treatment of Gastroparesis Using Different Acupoints.,"Objective
To explore the effect of ""selecting acupoints by site"" on the synergy effect of ""acupoint compatibility"" according to the clinical efficacy of acupuncture treatment of patients with gastroparesis.
Methods
A total of 99 patients who met the diagnostic criteria for gastroparesis were enrolled in 3 clinical centers and randomly divided into group A (33 cases), group B (33 cases, 1 case of shedding), and group C (33 cases, 1 case of shedding). In group A, acupuncture was performed at Zhongwan (CV 12) and Zusanli (ST 36); in group B, acupuncture was performed at Neiguan (PC 6) and Zusanli (ST 36); in group C, acupuncture was performed at nonacupoint and Zusanli (ST 36). Treatment was performed for 30 minutes every day, 5 days as a course of treatment. There were 2 days off between courses and three courses in total. Differences in a main symptom index of gastroparesis (GCSI) scores, 9 symptom scores, and a health questionnaire (SF-36) were compared between each group before and after treatment and 4 weeks after the end of treatment. The difference of gastric emptying rate was compared before and after treatment.
Results
The GCSI scores of each group after treatment and at follow-up were significantly lower than those before treatment ( P < 0.01), and the reduction in group A was greater than that of groups B and C ( P < 0.01). The score of each symptom was meaningfully lower than that before treatment ( P < 0.01 or P < 0.05). The effect was best in group A, followed by group B. After treatment, the barium meal in the stomach of the three groups was significantly reduced compared with before treatment ( P < 0.01). There was no statistical difference between the groups. The results of SF-36 showed that acupuncture treatment can improve health status, to a certain extent, and there was no significant difference in the three groups.
Conclusion
(1) Acupuncture is an effective method for the treatment of gastroparesis. (2) The combination of Zhongwan (CV 12) with Zusanli (ST 36) showed the most promising effect on relief of the symptoms in patients with gastroparesis. (3) ""Selecting acupoints by site"" is the key factor affecting the synergy effect of ""acupoint compatibility."" This trial was registered with the International Center for Clinical Trials (registration no. NCT02594397).",2020,The score of each symptom was meaningfully lower than that before treatment ( P < 0.01 or P < 0.05).,"['99 patients who met the diagnostic criteria for gastroparesis were enrolled in 3 clinical centers', 'patients with gastroparesis']","['acupuncture', 'Acupuncture']","['gastric emptying rate', 'GCSI scores', 'score of each symptom', 'health status', 'main symptom index of gastroparesis (GCSI) scores, 9 symptom scores, and a health questionnaire (SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0967114', 'cui_str': 'goblet cell silencer inhibitor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",99.0,0.0357108,The score of each symptom was meaningfully lower than that before treatment ( P < 0.01 or P < 0.05).,"[{'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Xuefen', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ping', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Xiaoli', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Zenghui', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}]",Pain research & management,['10.1155/2020/8751958']
180,32334033,Acute Toxicity and Quality of Life of Hypofractionated Radiation Therapy for Breast Cancer.,"PURPOSE
To assess the acute toxicity and quality of life (QOL) of hypofractionation compared with conventional fractionation for whole breast irradiation (WBI) after breast-conserving surgery.
METHODS AND MATERIALS
Women with node-negative breast cancer who had undergone breast-conserving surgery with clear margins were randomly assigned to conventional WBI of 5000 cGy in 25 fractions over 35 days or hypofractionated WBI of 4256 cGy in 16 fractions over 22 days. Acute skin toxicity and QOL were assessed at baseline and 2, 4, 6, and 8 weeks from the start of treatment for a subgroup of patients. QOL was assessed at baseline and 4 weeks posttreatment for all patients. In the acute toxicity substudy, repeated measures modeling was used to investigate treatment by time interactions over the 8-week period for acute toxicity and QOL mean change score. QOL mean change score from baseline to 4 weeks posttreatment was compared for all patients.
RESULTS
In the acute toxicity substudy, 161 patients participated. In the main trial, 1152 patients participated. Acute skin toxicity was initially similar between groups but was less with hypofractionation compared with conventional fractionation toward the end of the 8-week period (P < .001). QOL at 6 weeks from the start of treatment was improved with hypofractionation for the skin side effects, breast side effects, fatigue, attractiveness, and convenience domains (all P < .05). In the main trial, hypofractionation resulted in improved overall QOL and QOL attributed to skin side effects, breast side effects, and attractiveness (all P < .01).
CONCLUSIONS
Hypofractionated WBI compared with conventional WBI resulted in less acute toxicity and improved QOL. This further supports the benefits of hypofractionation.",2020,"QOL at 6 weeks from the start of treatment was improved with hypofractionation for the skin side effects, breast side effects, fatigue, attractiveness and convenience domains (all p < 0.05).","['1152 patients participated', 'Breast Cancer', 'Women with node negative breast cancer who had undergone BCS with clear margins']","['Hypofractionated Radiotherapy', 'conventional WBI', 'conventional fractionation for whole breast irradiation (WBI) following breast conserving surgery (BCS', 'conventional WBI of 5000 cGy in 25 fractions over 35 days or hypofractionated WBI']","['skin side effects, breast side effects, fatigue, attractiveness and convenience domains', 'acute toxicity and improved QOL', 'acute toxicity and QOL mean change score', 'QOL mean change score', 'Acute skin toxicity', 'QOL attributed to skin side effects, breast side effects, and attractiveness', 'QOL', 'Acute Toxicity and Quality of Life', 'Acute skin toxicity and QOL', 'overall QOL', 'acute toxicity and quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C1709157', 'cui_str': 'Tumor-Free Margins'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0556645', 'cui_str': 'cGy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1152.0,0.104901,"QOL at 6 weeks from the start of treatment was improved with hypofractionation for the skin side effects, breast side effects, fatigue, attractiveness and convenience domains (all p < 0.05).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Arsenault', 'Affiliation': 'Department of Radiation Oncology, Dr. Léon Richard Oncology Centre, Moncton, New Brunswick, Canada.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Parpia', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Goldberg', 'Affiliation': 'Division of Radiation Oncology, Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Rakovitch', 'Affiliation': 'Department of Radiation Oncology, University of Toronto and Odette Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Reiter', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Department of Radiation Oncology, University of Toronto and Odette Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Himu', 'Initials': 'H', 'LastName': 'Lukka', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sussman', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Whelan', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada. Electronic address: twhelan@hhsc.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.049']
181,32335316,Development and Evaluation of an SBAR-based Fall Simulation Program for Nursing Students.,"PURPOSE
The purpose of this study was to develop an Situation-Background-Assessment-Recommendation (SBAR) fall simulation program for Korean nursing students and to evaluate its effectiveness.
METHODS
This study used a single-blind randomized control pretest-posttest design. The 54 nursing students in their third semester at a college in Korea were selected through convenience sampling (SBAR group 26, handoff group 28). The SBAR-based program was provided to the experimental group, while the general handoff-based program was given to the control group. The program was designed for a total of three sessions each and no more than 120 minutes each. Measurement variables included the knowledge, skill, attitude, communication ability, and its clarity related to falls. The data were analyzed with x 2 test, t test, and repeated measures of ANOVA using the SPSS 18.0 program.
RESULTS
The SBAR group showed the improved fall-related skill and communication clarity compared with the handoff group. There was a significant difference in the fall-related knowledge only in a time-dependent manner before and after intervention, while there was no statistically significant difference in the attitude and communication ability related to falls.
CONCLUSIONS
SBAR-based simulation program revealed positive results in terms of patient safety of nursing college students compared with the general handoff-based method. Therefore, the SBAR-based simulation program is expected to be used as an educational intervention for nursing students not only to improve abilities in reporting and communication but to prevent or handle patient safety accidents efficiently.",2020,"There was a significant difference in the fall-related knowledge only in a time-dependent manner before and after intervention while there was no statistically significant difference in the attitude and communication ability related to falls.
","['Korean nursing students', 'nursing college students', '54 nursing students in their third semester at a college in Korea were selected through convenience sampling (SBAR group 26, handoff group 28', 'Nursing Students']","['SBAR fall simulation program', 'SBAR-based Fall Simulation Program', 'SBAR-based simulation program']","['fall-related knowledge', 'fall-related skill and communication clarity', 'attitude and communication ability related to falls', 'knowledge, skill, attitude, communication ability and its clarity related to falls']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0565998', 'cui_str': 'Ability to communicate'}]",,0.0136002,"There was a significant difference in the fall-related knowledge only in a time-dependent manner before and after intervention while there was no statistically significant difference in the attitude and communication ability related to falls.
","[{'ForeName': 'Jeong Hee', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Nursing, Daedong College, Busan, Republic of Korea.'}, {'ForeName': 'Eun Jeong', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Dong-A University, Busan, Republic of Korea. Electronic address: vividness@hanmail.net.'}]",Asian nursing research,['10.1016/j.anr.2020.04.004']
182,32335343,"Safety and efficacy of memantine for multiple sclerosis-related fatigue: A pilot randomized, double-blind placebo-controlled trial.","BACKGROUND
Fatigue is one of the most common symptoms in patients with multiple sclerosis (MS). Currently, there is no approved medication for MS-related fatigue.
OBJECTIVE
In this study, we aim to evaluate the safety and efficacy of memantine for improving fatigue in patients with MS.
METHODS
This was a pilot randomized, double-blind, placebo-controlled clinical trial. Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria were randomized to receive either memantine (20 mg/day) or placebo and were assessed at baseline and three months after treatment. The change in the severity of fatigue was determined by the Modified Fatigue Impact Scale (MFIS).
RESULTS
Sixty-four patients were randomly allocated to the memantine (n = 32) and placebo (n = 32) groups. Sixteen patients in the memantine group and 24 patients in the placebo group completed the study. The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702). No serious adverse events were reported, except for dizziness and sedation in four patients in the experimental arm, which resulted in discontinuation.
CONCLUSION
This trial failed to prove any clinical efficacy of memantine for the management of MS-related fatigue. Although memantine was generally well-tolerated, adverse events were among the major causes of dropout in this study.",2020,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","['multiple sclerosis-related fatigue', 'Sixteen patients in the memantine group and 24 patients in the', 'patients with MS', 'Sixty-four patients', 'patients with multiple sclerosis (MS', 'Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria']","['placebo', 'memantine']","['MFIS scores', 'tolerated, adverse events', 'Safety and efficacy', 'serious adverse events', 'safety and efficacy', 'severity of fatigue', 'dizziness and sedation', 'Modified Fatigue Impact Scale (MFIS']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960438', 'cui_str': 'Fatigue impact scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}]",64.0,0.542728,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Falsafi', 'Affiliation': 'Department of Neurology, Alavi Hospital, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tafakhori', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mojarrad', 'Affiliation': 'School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Dehghani', 'Affiliation': 'Molecular Immunology Research Center, School of Medicine, Tehran University of Medical Science, Tehran 1419783151, Iran; Network of Immunity in Infection, Malignancy, and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Los Angeles, CA 90001, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghaffarpour', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ghafarpour@tums.ac.ir.'}, {'ForeName': 'Vajiheh', 'Initials': 'V', 'LastName': 'Aghamollaii', 'Affiliation': 'Department of Neurology, Roozbeh Hospital, Tehran University of Medical Sciences, Roozbeh Hospital, Tehran, Iran.'}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Mousavi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fouladi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Pourghaz', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pargol', 'Initials': 'P', 'LastName': 'Balali', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Harirchian', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: harirchm@tums.ac.ir.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116844']
183,32334176,"The RESPECT trial-Replacement of peripheral intravenous catheters according to clinical reasons or every 96 h: A randomized, controlled, non-inferiority trial.","BACKGROUND
Peripheral intravenous catheters are widely used for infusion therapy. To prevent phlebitis, routine catheter replacement at 72 or 96 h remains widely practiced.
OBJECTIVE
To investigate the non-inferiority of clinically indicated peripheral intravenous catheter replacement compared with routine replacement every 96 h to prevent phlebitis. Phlebitis severity, catheter indwelling time, and other catheter failure types were also compared.
SETTING
Multi-center trial in wards at two hospitals in Sao Paulo, Brazil.
DESIGN
The REplacement of PEripheral intravenous CaTheters according to clinical signs or every 96 h (RESPECT) trial was a Randomized, non-blinded, controlled, non-inferiority trial.
PARTICIPANTS
1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96 h; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided. Exclusion criteria were: bloodstream infection and/or sepsis, neutrophil count of ≤1000/mm 3 , and simultaneous use of more than one peripheral intravenous catheter. Recruitment occurred within 96 h of peripheral intravenous catheter insertion. Randomization was performed using a computer-generated, concealed list.
METHODS
As intervention, clinically indicated replacement group patients underwent peripheral intravenous catheter removal only at the end of therapy or in the presence of phlebitis, infiltration, occlusion, displacement, accidental removal, or bloodstream infection. Routine 96-h replacement group patients (control) had their catheters replaced every 96-h, unless clinical reasons required earlier replacement. The primary outcome was Phlebitis and the analyses were carried out on intention-to-treat and per-protocol bases.
RESULTS
Demographic and clinical variables were similar between groups, with the exception to type of admission (p = 0.025) more frequent in clinically indicated patients and surgical on routine replacement group. Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis. Phlebitis/1000 catheter-days, was 14.9 in the clinically indicated group and 23.8 in the routine replacement group (p = 0.006). The survival analysis showed no significant between-group difference in the occurrence of the first phlebitis episode.
CONCLUSIONS
Clinically indicated peripheral intravenous catheter replacement was not inferior to routine (96 h) replacement regarding phlebitis occurrence, and was associated with significantly less phlebitis per 1000 days.
TRIAL REGISTRATION
Registered with www.clinicaltrials.gov (NCT02568670).",2020,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","['Multi-center trial in wards at two hospitals in Sao Paulo, Brazil', '1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96\xa0h; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided']","['peripheral intravenous catheters', 'peripheral intravenous catheter replacement', 'peripheral intravenous catheter removal']","['Phlebitis', 'phlebitis', 'intention-to-treat and per-protocol bases', 'Phlebitis severity, catheter indwelling time, and other catheter failure types']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",1319.0,0.175394,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Vendramim', 'Affiliation': 'Specialist in pediatric intensive care, M.Sc., Ph.D. in Health Science of Federal University of Sao Paulo, 258 Aimberê, St. Sao Paulo, Brazil. Electronic address: patvendramim@gmail.com.'}, {'ForeName': 'Ariane Ferreira Machado', 'Initials': 'AFM', 'LastName': 'Avelar', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: ariane.machado@unifesp.br.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Griffith University - Australia, Australia. Electronic address: c.rickard@griffith.edu.au.'}, {'ForeName': 'Mavilde da Luz Gonçalves', 'Initials': 'MDLG', 'LastName': 'Pedreira', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: mpedreira@unifesp.br.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.103504']
184,31219152,Depressive Symptoms Assessed Near the End of Pregnancy Predict Differential Response to Postpartum Smoking Relapse Prevention Intervention.,"BACKGROUND
Depressive symptoms are prevalent during pregnancy and the postpartum period and affect risk for smoking relapse. Whether and how depression affects response to postpartum interventions designed to sustain smoking abstinence is unknown.
PURPOSE
We examined end-of-pregnancy depressive symptoms as a moderator of response to two postpartum-adapted smoking relapse prevention interventions.
METHODS
Women (N = 300) who quit smoking during pregnancy were randomized to receive either a postpartum intervention focused on psychosocial factors linked to postpartum smoking (Strategies to Avoid Returning to Smoking [STARTS]) or an attention-controlled comparison intervention (SUPPORT). Women completed the Edinburgh Postnatal Depression Scale at the end of pregnancy. Smoking status was biochemically assessed at the end of pregnancy and at 12, 24, and 52 weeks postpartum.
RESULTS
End-of-pregnancy depressive symptoms moderated response to postpartum smoking relapse prevention interventions (χ2 = 10.18, p = .001). After controlling for variables previously linked to postpartum smoking relapse, women with clinically significant end-of-pregnancy depressive symptoms (20%) were more likely to sustain abstinence through 52 weeks postpartum if they received STARTS. In contrast, women with few end-of-pregnancy depressive symptoms were more likely to sustain abstinence through 52 weeks postpartum if they received SUPPORT. Changes in the psychosocial factors addressed in the STARTS intervention did not mediate this moderation effect.
CONCLUSION
Assessment of end-of-pregnancy depressive symptoms may help determine success following postpartum smoking relapse prevention interventions. Women with elevated end-of-pregnancy depressive symptoms benefited from postpartum relapse prevention intervention tailored to their psychosocial needs, while those with few symptoms were more successful in postpartum intervention that used standard behavioral components.
CLINICAL TRIAL REGISTRATION
NCT00757068.",2020,"Women with elevated end-of-pregnancy depressive symptoms benefited from postpartum relapse prevention intervention tailored to their psychosocial needs, while those with few symptoms were more successful in postpartum intervention that used standard behavioral components.
","['Women with elevated end-of-pregnancy depressive symptoms', 'Women (N = 300) who quit smoking during pregnancy']",['postpartum intervention focused on psychosocial factors linked to postpartum smoking (Strategies to Avoid Returning to Smoking [STARTS]) or an attention-controlled comparison intervention (SUPPORT'],"['Edinburgh Postnatal Depression Scale', 'pregnancy depressive symptoms', 'Smoking status']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",300.0,0.0865372,"Women with elevated end-of-pregnancy depressive symptoms benefited from postpartum relapse prevention intervention tailored to their psychosocial needs, while those with few symptoms were more successful in postpartum intervention that used standard behavioral components.
","[{'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Levine', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Emery', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Kolko Conlon', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Marsha D', 'Initials': 'MD', 'LastName': 'Marcus', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Germeroth', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Salk', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Statistics and Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz026']
185,32387716,Hypertension During Diabetic Ketoacidosis in Children.,"OBJECTIVES
To characterize hemodynamic alterations occurring during diabetic ketoacidosis (DKA) in a large cohort of children and to identify clinical and biochemical factors associated with hypertension.
STUDY DESIGN
This was a planned secondary analysis of data from the Pediatric Emergency Care Applied Research Network (PECARN) Fluid Therapies Under Investigation in DKA (FLUID) Study, a randomized clinical trial of fluid resuscitation protocols for children in DKA. Hemodynamic data (heart rate, blood pressure) from children with DKA were assessed in comparison with normal values for age and sex. Multivariable statistical modeling was used to explore clinical and laboratory predictors of hypertension.
RESULTS
Among 1258 DKA episodes, hypertension was documented at presentation in 154 (12.2%) and developed during DKA treatment in an additional 196 (15.6%), resulting in a total of 350 DKA episodes (27.8%) in which hypertension occurred at some time. Factors associated with hypertension at presentation included more severe acidosis, (lower pH and lower PCO 2 ), and stage 2 or 3 Acute Kidney Injury (AKI). More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
CONCLUSIONS
Despite dehydration, hypertension occurs in a substantial number of children with DKA. Factors associated with hypertension include greater severity of acidosis, lower PCO 2 and lower GCS scores during DKA treatment, suggesting that hypertension might be centrally mediated.",2020,"More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
","['children with DKA', 'children in DKA', 'Hypertension During Diabetic Ketoacidosis in Children']",[],"['severity of acidosis, lower PCO 2 and lower GCS scores', 'Hemodynamic data (heart rate, blood pressure', 'severe acidosis and lower Glasgow Coma Scale (GCS) scores', 'hypertension']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.0665684,"More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'DePiero', 'Affiliation': 'Division of Emergency Medicine, Department of Pediatrics, Nemours/A.I. DuPont Hospital for Children, Sidney Kimmel Medical College at Thomas Jefferson University.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, University of California Davis Health, University of California Davis, School of Medicine; Department of Pediatrics, University of California Davis Health, University of California Davis, School of Medicine.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's National Medical Center, The George Washington School of Medicine and Health Sciences.""}, {'ForeName': 'Jeff E', 'Initials': 'JE', 'LastName': 'Schunk', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'McManemy', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine.""}, {'ForeName': 'Arleta', 'Initials': 'A', 'LastName': 'Rewers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Colorado Children's Hospital, University of Colorado-Denver School of Medicine.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Stoner', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University School of Medicine.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tzimenatos', 'Affiliation': 'Department of Emergency Medicine, University of California Davis Health, University of California Davis, School of Medicine.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Garro', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, Rhode Island Hospital, The Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Sage R', 'Initials': 'SR', 'LastName': 'Myers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania.""}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Quayle', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine in St. Louis.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Trainor', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine.""}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Kwok', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, New York Presbyterian Morgan Stanley Children's Hospital, Columbia University College of Physicians and Surgeons.""}, {'ForeName': 'Lise E', 'Initials': 'LE', 'LastName': 'Nigrovic', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School.""}, {'ForeName': 'Cody S', 'Initials': 'CS', 'LastName': 'Olsen', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Ghetti', 'Affiliation': 'Department of Psychology, University of California Davis.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Glaser', 'Affiliation': 'Department of Pediatrics, University of California Davis Health, University of California Davis, School of Medicine. Electronic address: nsglaser@ucdavis.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.066']
186,32387962,"Long-term treatment of chronic orofacial, pudendal, and central neuropathic limb pain with repetitive transcranial magnetic stimulation of the motor cortex.","OBJECTIVE
To assess the long-term analgesic effects of high-frequency repetitive transcranial magnetic stimulation (rTMS) of the motor cortex in patients with chronic pain syndrome.
METHODS
The study included 57 patients (orofacial pain, n = 26, pudendal neuralgia, n = 18, and neuropathic limb pain, n = 13) with an ""induction phase"" of 12 daily rTMS sessions for 3 weeks, followed by a ""maintenance phase"" of bi-monthly sessions for the next five months.
RESULTS
All pain measures significantly decreased from baseline to the end of the induction phase. Analgesic response, defined as pain intensity decrease ≥ 30% compared to baseline, was observed in 39 patients (68%), who could be differentiated from non-responders from the 7th rTMS session. At the end of the maintenance phase (D180), 27 patients (47%) were still responders. Anxio-depressive symptoms and quality of life also improved. The analgesic response at the end of the induction phase was associated with lower pain score at baseline, and the response at the end of the maintenance phase was associated with lower anxio-depressive score at baseline.
CONCLUSION
The analgesic efficacy of motor cortex rTMS can be maintained in the long term in various chronic pain conditions. Patients with high pain level and severe anxio-depressive symptoms may have a less favorable profile to respond to the procedure.
SIGNIFICANCE
The overall impact of rTMS treatment on daily life requires a multidimensional evaluation that goes beyond the analgesic effect that can be achieved.",2020,All pain measures significantly decreased from baseline to the end of the induction phase.,"['patients with chronic pain syndrome', '57 patients (orofacial pain, n\xa0=\xa026, pudendal neuralgia, n\xa0=\xa018, and neuropathic limb pain, n\xa0=\xa013) with an ""induction phase"" of 12 daily rTMS sessions for 3\xa0weeks, followed by a ""maintenance phase"" of bi-monthly sessions for the next five months', 'Patients with high pain level and severe anxio-depressive symptoms']","['high-frequency repetitive transcranial magnetic stimulation (rTMS', 'repetitive transcranial magnetic stimulation', 'rTMS', 'motor cortex rTMS']","['pain intensity decrease\xa0≥', 'anxio-depressive score', 'Anxio-depressive symptoms and quality of life', 'analgesic response', 'lower pain score', 'Analgesic response', 'All pain measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1298685', 'cui_str': 'Chronic pain syndrome'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C1997249', 'cui_str': 'Pudendal neuralgia'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",57.0,0.0662332,All pain measures significantly decreased from baseline to the end of the induction phase.,"[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Hodaj', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France. Electronic address: HHodaj@chu-grenoble.fr.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France.'}, {'ForeName': 'Enkelejda', 'Initials': 'E', 'LastName': 'Hodaj', 'Affiliation': ""Centre d'Investigation Clinique, CHU Grenoble Alpes, F-38000 Grenoble, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dumolard', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Maindet', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Cracowski', 'Affiliation': ""Centre d'Investigation Clinique, CHU Grenoble Alpes, F-38000 Grenoble, France.""}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Delon-Martin', 'Affiliation': 'Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France.'}, {'ForeName': 'Jean-Pascal', 'Initials': 'JP', 'LastName': 'Lefaucheur', 'Affiliation': 'EA 4391, Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor, Université Paris Est Créteil, Créteil, France.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.03.022']
187,32389006,Effectiveness of a comprehensive post-operative health education program in improving quality of life after gastric cancer surgery.,"BACKGROUND
Patients with gastric cancer often experience postoperative problems such as dumping syndrome, abdominal cramps, and nausea, which have profound effects on their mental health and quality of life. Earlier studies have shown that comprehensive health education can dramatically improve the quality of life of cancer patients after surgery. Thus, in this study, we conducted a health education intervention program in patients who had undergone surgical treatment for gastric cancer and evaluated the effectiveness of this program in improving the postoperative quality of life, with an attempt to offer evidence for better postoperative management of gastric cancer patients.
METHODS
Totally, 80 patients with gastric cancer who underwent surgery at our center from February 2018 to February 2019 were equally divided into an observation group and control group according to the random number table method. The observation group was offered with interventions regarding health education, including disease awareness-raising, instructions on behavior and lifestyle, rehabilitation management, and mental health counseling, and the control group received the routine nursing intervention. The quality of life one month before and after surgery was assessed by using the Chinese version of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-STO22.
RESULTS
The baseline data and quality of life showed no significant differences between the observation group and the control group one month before surgery (both P>0.05). One month after the surgery, the scores of dysphagia, pain/discomfort, reflux symptoms, and emotional issues and overall score in the observation group decreased significantly (34.86±2.170, 38.66±3.08, 32.26±2.76, 49.55±4.20, and 54.26±7.03, respectively), which were also significantly lower than those in the control group (36.33±3.10, 44.29±3.72, 33.64±3.10, 53.56±3.25, and 60.17±7.28, respectively; all P<0.05).
CONCLUSIONS
The comprehensive health education intervention program can effectively improve the quality of life in patients after gastric cancer surgery and deserves further application in clinical settings.",2020,The baseline data and quality of life showed no significant differences between the observation group and the control group one month before surgery (both P>0.05).,"['patients who had undergone surgical treatment for gastric cancer', '80 patients with gastric cancer who underwent surgery at our center from February 2018 to February 2019', 'gastric cancer patients', 'Patients with gastric cancer', 'after gastric cancer surgery', 'patients after gastric cancer surgery', 'cancer patients after surgery']","['health education intervention program', 'interventions regarding health education, including disease awareness-raising, instructions on behavior and lifestyle, rehabilitation management, and mental health counseling, and the control group received the routine nursing intervention', 'comprehensive post-operative health education program']","['quality of life', 'scores of dysphagia, pain/discomfort, reflux symptoms, and emotional issues and overall score', 'baseline data and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",80.0,0.0296071,The baseline data and quality of life showed no significant differences between the observation group and the control group one month before surgery (both P>0.05).,"[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Second Ward, Department of Gastrointestinal Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Second Ward, Department of Gastrointestinal Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hou', 'Affiliation': 'Second Ward, Department of Gastrointestinal Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Lixiu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Second Ward, Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China. lihuiyanlhyy@sina.com.'}]",Annals of palliative medicine,['10.21037/apm.2020.04.14']
188,32389012,Efficacy and safety of Qinzhuliangxue decoction for treating atopic eczema: a randomized controlled trial.,"BACKGROUND
Atopic eczema is the most common type of skin disorder in both children and adults. It is characterized by erythema, pruritus, papules, xeransis, and lichenification. Qinzhuliangxue decoction (QZLXD), a Chinese herbal medicine (CHM) prepared with several ingredients that are used to treat eczema, was formulated according to the traditional Chinese medicine (TCM) theory. This study aimed to investigate the efficacy and safety of QZLXD administration for treating atopic eczema compared to those of Runzaozhiyang capsules (RZZYC).
METHODS
A total of 176 patients were enrolled at the Shanghai Yueyang Hospital and were randomly assigned to the QZLXD treatment group (n=82) or the RZZYC control group (n=86). The differences in Eczema Area and Severity Index (EASI), Dermatology Life Quality Index, itching score, recurrence rate, and adverse events (AEs) were compared between the groups.
RESULTS
The EASI score (x2=14.181, P=0.003), recurrence rate (x2=7.398, P=0.007), and itching score (F=-3.427, P=0.001) were lower in the QZLXD group than in the RZZYC group. Incidence of AEs was similar between the RZZYC and QZLXD groups (P=0.434).
CONCLUSIONS
QZLXD is recommended for the treatment of subacute atopic eczema because QZLXD showed good efficiency with low recurrence rate and tolerable AEs.",2020,"Incidence of AEs was similar between the RZZYC and QZLXD groups (P=0.434).
","['176 patients were enrolled at the Shanghai Yueyang Hospital', 'atopic eczema']","['Qinzhuliangxue decoction (QZLXD', 'Runzaozhiyang capsules (RZZYC', 'Qinzhuliangxue decoction', 'RZZYC control', 'QZLXD', 'Chinese herbal medicine (CHM']","['Efficacy and safety', 'efficacy and safety', 'Eczema Area and Severity Index (EASI), Dermatology Life Quality Index, itching score, recurrence rate, and adverse events (AEs', 'Incidence of AEs', 'itching score', 'recurrence rate', 'EASI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",176.0,0.111501,"Incidence of AEs was similar between the RZZYC and QZLXD groups (P=0.434).
","[{'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Department of Surgery of Traditional Chinese Medicine, Xiangshan Traditional Chinese Medicine Hospital, Shanghai 200020, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China. xuwenbin@shyueyanghospital.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China. 13661956326@163.com.'}]",Annals of palliative medicine,['10.21037/apm.2020.04.17']
189,32389740,Administration of commensal Shewanella sp. MR-7 ameliorates lipopolysaccharide-induced intestine dysfunction in turbot (Scophthalmus maximus L.).,"This study was designed to evaluate whether the administration of commensal Shewanella sp. MR-7 (MR-7) could ameliorate lipopolysaccharide (LPS)-induced intestine dysfunction in turbot. Fish (body weight: 70.00 ± 2.00 g) were randomly divided into three groups including the control group treated with dough, the LPS group treated with dough plus LPS, and the LPS+MR-7 (LMR) group treated with dough plus LPS and MR-7. These three groups with 24 fish each were force-fed with 1 g dough daily for 7 continuous days. The results revealed that MR-7 administration ameliorated LPS-induced intestinal injury, showing higher intestinal villus and microvillus height. Further results showed that MR-7 could inhibit LPS-induced activation of TLR-NF-κB signaling thus maintaining the normal expression levels of cytokines and finally ameliorate the intestinal inflammatory response in turbot. Compared with the LPS group, LMR group had less goblet cells and lower mucin-2 expression level. Moreover, MR-7 restored LPS-induced down-regulation of tight junction protein-related gene expression (zonula occluden-1, occludin, tricellulin and claudin-3). Further investigations indicated that MR-7 partially counteracted LPS-induced changes in gut microbiota composition, enhanced the beneficial bacteria Lactobacillus and reduced the Pseudomonas, thus maintaining the overall microbiota balance. Taken together, the administration of MR-7 could effectively restore LPS-induced intestine function disorder in turbot by ameliorating inflammatory response, mucosal barrier dysfunction and microbiota dysbiosis.",2020,"Moreover, MR-7 restored LPS-induced down-regulation of tight junction protein-related gene expression (zonula occluden-1, occludin, tricellulin and claudin-3).",[],"['control group treated with dough, the LPS group treated with dough plus LPS, and the LPS+MR-7 (LMR) group treated with dough plus LPS and MR-7', 'commensal Shewanella sp. MR-7', 'LPS', 'LMR', 'MR-7']","['gut microbiota composition', 'overall microbiota balance', 'intestinal villus and microvillus height', 'goblet cells and lower mucin-2 expression level']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0542329', 'cui_str': 'Commensal parasite'}, {'cui': 'C0579220', 'cui_str': 'Shewanella'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0227266', 'cui_str': 'Intestinal villus'}, {'cui': 'C0026049', 'cui_str': 'Microvillus'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0506994', 'cui_str': 'Goblet Cells'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1528289', 'cui_str': 'MUC2 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.019845,"Moreover, MR-7 restored LPS-induced down-regulation of tight junction protein-related gene expression (zonula occluden-1, occludin, tricellulin and claudin-3).","[{'ForeName': 'Beili', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Chaoqun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Chengdong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Kangsen', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China; Laboratory for Marine Fisheries Science and Food Production Processes, Qingdao National Laboratory for Marine Science and Technology, Qingdao, 266237, China. Electronic address: hegen@ouc.edu.cn.'}]",Fish & shellfish immunology,['10.1016/j.fsi.2020.04.068']
190,32389808,Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial.,"INTRODUCTION
Maternal obesity increases neonatal risk for obesity and metabolic syndrome later in life. Prior attempts to break this intergenerational obesity cycle by limiting excessive gestational weight gain have failed to reduce neonatal adiposity. Alternatively, pre-conception lifestyle interventions may improve the in utero metabolic milieu during early pregnancy leading to improved fetal outcomes. This randomized controlled trial (RCT) is evaluating whether a lifestyle intervention to reduce weight and improve maternal metabolism in preparation for pregnancy (LIPP) attenuates neonatal adiposity, compared to standard medical advice.
MATERIAL AND METHODS
Overweight/class 1 obese women after a previous pregnancy, ~12 weeks postpartum, preparing for a subsequent pregnancy, will be block randomized (1:1) to either LIPP or standard of care in a parallel design. Randomization is stratified by lactation status and overweight vs. class 1 obesity. The LIPP program consists of intensive short-term weight loss followed by weight maintenance until conception using supervised exercise and a low glycemic Mediterranean diet.
PRIMARY OUTCOMES
Group differences in neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism.
SECONDARY OUTCOMES
Group differences in maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life. Exploratory outcomes include umbilical cord blood insulin resistance, lipid profile and inflammation.
DISCUSSION
This RCT will determine the efficacy of maternal weight loss prior to pregnancy on reducing neonatal adiposity. Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
CLINICAL TRIAL REGISTRATION
NCT03146156.",2020,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","['pregnancy (LIPP', 'Overweight/class 1 obese women after a previous pregnancy, ~12', 'women planning for pregnancy']","['LIPP', 'lifestyle intervention']","['umbilical cord blood insulin resistance, lipid profile and inflammation', 'maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life', 'utero metabolic milieu', 'neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",1.0,0.119724,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America; Department of Translational Services, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gordesky', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Barkoukis', 'Affiliation': 'Department of Nutrition, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""O'Tierney-Ginn"", 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, 711 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America. Electronic address: John.Kirwan@pbrc.edu.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Catalano', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America. Electronic address: pcatalano@tuftsmedicalcenter.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106024']
191,32392863,The Effect of Mind Subtraction Meditation Intervention on Smartphone Addiction and the Psychological Wellbeing among Adolescents.,"As the smartphone has become an indispensable device in modern lives, consequential psychosocial problems such as smartphone addiction have been getting attention worldwide, especially regarding adolescents. Based on its positive effect on young individuals' mental health, mind subtraction meditation has been widely applied to many school-based programs in South Korea. This study aims to identify the effects of a school program based on mind subtraction on the smartphone addiction of adolescents. A total of 49 high school sophomores, 24 from the experimental group (mean age = 16), and 25 from the control group (mean age = 16) are included in this case-control study. The experimental group is given the meditation program sessions in the morning, two times a week for 20 min per session, for a total of 12 weeks. The experimental group shows improvements regarding the 'smartphone addiction' section ( p < 0.001), for instant satisfaction ( p < 0.001) and long-term satisfaction ( p < 0.001). Concerning the 'self-control' section and decreasing stress ( p < 0.001), problem focusing ( p < 0.001), and social support navigation ( p = 0.018), there are improvements in these 'stress coping strategies' sections. This study directly shows the positive effect of mind subtraction meditation on smartphone addiction in adolescents and, thus, provides guidance to the future development of smartphone addiction prevention programs for young individuals.",2020,"The experimental group shows improvements regarding the 'smartphone addiction' section ( p < 0.001), for instant satisfaction (","['Adolescents', ""young individuals' mental health"", 'young individuals', 'A total of 49 high school sophomores, 24 from the experimental group (mean age = 16), and 25 from the control group (mean age = 16) are included in this case-control study', 'adolescents']","['meditation program sessions', 'Mind Subtraction Meditation Intervention', 'mind subtraction meditation', 'school program based on mind subtraction']","['Smartphone Addiction and the Psychological Wellbeing', ""smartphone addiction' section"", 'long-term satisfaction', 'instant satisfaction ', 'social support navigation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",49.0,0.016192,"The experimental group shows improvements regarding the 'smartphone addiction' section ( p < 0.001), for instant satisfaction (","[{'ForeName': 'Eun-Hi', 'Initials': 'EH', 'LastName': 'Choi', 'Affiliation': 'Department of Nursing, Eulji University, Daejeon 34824, Korea.'}, {'ForeName': 'Min Young', 'Initials': 'MY', 'LastName': 'Chun', 'Affiliation': ""Department of Global Medical Science, Sungshin Women's University, Seoul 02844, Korea.""}, {'ForeName': 'Insoo', 'Initials': 'I', 'LastName': 'Lee', 'Affiliation': 'Department of Paramedic Science, Korea National University of Transportation, Chungcheongbuk-do 27909, Korea.'}, {'ForeName': 'Yang-Gyeong', 'Initials': 'YG', 'LastName': 'Yoo', 'Affiliation': 'Department of Nursing, Kunsan National University, Jeollabuk-do 54150, Korea.'}, {'ForeName': 'Min-Jae', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': ""Research Institute of Basic Science, Sungshin Women's University, Seoul 02844, Korea.""}]",International journal of environmental research and public health,['10.3390/ijerph17093263']
192,32394650,[Significance and operation mode of moxibustion intervention for the group under quarantine after close contact with COVID-19].,"On the base of the idea of traditional Chinese medicine as ""disease prevention"", the mode and the protocol of the moxibustion intervention for the group under quarantine after close contact with coronavirus disease 2019 (COVID-19) were explored. The group under quarantine after close contact with COVID-19 was taken as the subjects. By the non-contact physician-patient communication network platform co-developed by China Association of Acupuncture-Moxibustion, Hunan Provincial Association of Acupuncture-Moxibustion, Data Center of China Academy of Chinese Medical Sciences and Yuge Medicine Company, an exploratory randomized controlled trial was designed. A total of 100 cases were included and randomized into a moxibustion group and a conventional intervention group, 50 cases in each one. In the moxibustion group, moxibustion intervention was used. In the conventional intervention group, the conventional observation was adopted without moxibusiton intervention applied. The outcomes included the symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc. The results were evaluated before intervention, in 14 days of intervention and 2 weeks after intervention separately. In this research, on the base of internet plus technology and with the internet communication platform adopted, through mobile phone WeChat App, it was to implement the subject screen, the random allocation and the instruction of moxibustion intervention as well as the quality control of patient's diary and data collection. It is anticipated that the significance and the implementation mode of moxibustion intervention can be assessed preliminarily for the group under quarantine after close contact with COVID-19.",2020,"The outcomes included the symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc.",['A total of 100 cases'],"['moxibustion intervention', 'moxibustion', 'conventional intervention']","['symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013985', 'cui_str': 'Emotional Disturbances'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",100.0,0.0282429,"The outcomes included the symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc.","[{'ForeName': 'Mai-Lan', 'Initials': 'ML', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Ai', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Guo-Bin', 'Initials': 'GB', 'LastName': 'Dai', 'Affiliation': 'Business School of Central South University.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'First Affiliated Hospital of Hunan University of CM.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Chang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Bao-Yan', 'Initials': 'BY', 'LastName': 'Liu', 'Affiliation': 'China Academy of Chinese Medical Sciences, Beijing 100700.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200224-k0004']
193,32399578,"Zinc Oxide Inhibits Axillary Colonization by Members of the Genus Corynebacterium and Attenuates Self-perceived Malodour: A Randomized, Double-blind, Placebo-controlled Trial.","Malodour from the axilla is commonly caused by specific microbes, and may be inhibited by zinc oxide. The aim of this study was to determine the effects of zinc oxide on the axillary microbiota, odour and pH in a randomized, double-blind, placebo-controlled trial in 30 healthy volunteers. In each participant 1 axilla was treated with zinc oxide and the other with a placebo for 13 days. The microbiota and pH were analysed before and during treatment. At the final visit, the participants judged their own axillary odour for comparison. With zinc oxide treatment total bacterial growth and, specifically, that of odour-producing Corynebacterium spp. and Staphylococcus hominis, decreased (p < 0.05), despite an increase (p < 0.0005) in skin-surface pH. Compared with the placebo, zinc oxide treatment reduced (p = 0.005) self-perceived malodour. In vitro, Corynebacterium spp. (19 isolated strains) survival was reduced (p < 0.0005) at pH 5.0 compared with pH 6.0; growth inhibition by zinc oxide occurred at ≤ 400 mg/l, and cell death occurred at ≤ 10,000 mg/l for 12 (63%) of the strains. In conclusion, application of zinc oxide reduced malodour and the counts of causative bacteria, but increased the pH of the axilla.",2020,"and Staphylococcus hominis, decreased (p < 0.05), despite an increase (p < 0.0005) in skin-surface pH. Compared with the placebo, zinc oxide treatment reduced (p = 0.005) self-perceived malodour.","['Members of the Genus Corynebacterium and Attenuates Self-perceived Malodour', '30 healthy volunteers']","['Placebo', 'placebo, zinc oxide', 'zinc oxide', 'Zinc Oxide', 'placebo']","['cell death', 'growth inhibition by zinc oxide', 'microbiota and pH', 'counts of causative bacteria']","[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0010148', 'cui_str': 'Corynebacterium'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043491', 'cui_str': 'Zinc Oxide'}]","[{'cui': 'C0007587', 'cui_str': 'Cell death'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0043491', 'cui_str': 'Zinc Oxide'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",30.0,0.376573,"and Staphylococcus hominis, decreased (p < 0.05), despite an increase (p < 0.0005) in skin-surface pH. Compared with the placebo, zinc oxide treatment reduced (p = 0.005) self-perceived malodour.","[{'ForeName': 'Magnus S', 'Initials': 'MS', 'LastName': 'Ågren', 'Affiliation': 'Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital, University of Copenhagen, DK-2400 Copenhagen NV, Denmark. E-mail: magnusspagren@gmail.com.'}, {'ForeName': 'Khaled S A', 'Initials': 'KSA', 'LastName': 'Ghathian', 'Affiliation': ''}, {'ForeName': 'Amalie K S', 'Initials': 'AKS', 'LastName': 'Frederiksen', 'Affiliation': ''}, {'ForeName': 'Morten J', 'Initials': 'MJ', 'LastName': 'Bjerrum', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Calum', 'Affiliation': ''}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Danielsen', 'Affiliation': ''}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Menon', 'Affiliation': ''}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Hædersdal', 'Affiliation': ''}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jorgensen', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3499']
194,32336148,Composite active range of motion (CX A ) and relationship with active function in upper and lower limb spastic paresis.,"OBJECTIVE
The aim of this study is to evaluate a novel composite measure of active range of motion (X A ) and determine whether this measure correlates with active function.
DESIGN
Post hoc analysis of two randomized, placebo-controlled, double-blind studies with open-label extensions exploring changes in active function with abobotulinumtoxinA.
SETTING
Tertiary rehabilitation centers in Australia, Europe, and the United States.
SUBJECTS
Adults with upper ( n = 254) or lower ( n = 345) limb spastic paresis following stroke or brain trauma.
INTERVENTIONS
AbobotulinumtoxinA (⩽5 treatment cycles) in the upper or lower limb.
MAIN MEASURES
X A was used to calculate a novel composite measure (CX A ), defined as the sum of X A against elbow, wrist, and extrinsic finger flexors (upper limb) or soleus and gastrocnemius muscles (lower limb). Active function was assessed by the Modified Frenchay Scale and 10-m comfortable barefoot walking speed in the upper limb and lower limb, respectively. Correlations between CX A and active function at Weeks 4 and 12 of open-label cycles were explored.
RESULTS
CX A and active function were moderately correlated in the upper limb ( P < 0.0001-0.0004, r = 0.476-0.636) and weakly correlated in the lower limb ( P < 0.0001-0.0284, r = 0.186-0.285) at Weeks 4 and 12 of each open-label cycle. Changes in CX A and active function were weakly correlated only in the upper limb (Cycle 2 Week 12, P = 0.0160, r = 0.213; Cycle 3 Week 4, P = 0.0031, r = 0.296). Across cycles, CX A improvements peaked at Week 4, while functional improvements peaked at Week 12.
CONCLUSION
CX A is a valid measure for functional impairments in spastic paresis. CX A improvements following abobotulinumtoxinA injection correlated with and preceded active functional improvements.",2020,"A and active function were moderately correlated in the upper limb ( P < 0.0001-0.0004, r = 0.476-0.636) and weakly correlated in the lower limb ( P < 0.0001-0.0284, r = 0.186-0.285) at Weeks 4 and 12 of each open-label cycle.","['upper and lower limb spastic paresis', 'Adults with upper ( n \u2009=\u2009254) or lower ( n \u2009=\u2009345) limb spastic paresis following stroke or brain trauma', 'spastic paresis', 'Tertiary rehabilitation centers in Australia, Europe, and the United States']","['abobotulinumtoxinA injection', 'CX', 'AbobotulinumtoxinA', 'Composite active range of motion (CX A ', 'placebo']","['Active function', 'active functional improvements', 'active function']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0747265', 'cui_str': 'Spastic paresis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0630058,"A and active function were moderately correlated in the upper limb ( P < 0.0001-0.0004, r = 0.476-0.636) and weakly correlated in the lower limb ( P < 0.0001-0.0284, r = 0.186-0.285) at Weeks 4 and 12 of each open-label cycle.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bayle', 'Affiliation': 'EA 7377 BIOTN, Service de Rééducation Neurolocomotrice, Université Paris-Est Créteil, Hospital Albert Chenevier-Henri Mondor, Créteil, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Maisonobe', 'Affiliation': 'Biometry, Ipsen Pharma, Boulogne-Billancourt, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Raymond', 'Affiliation': 'Biostatistics, Ividata, Levallois-Perret, France.'}, {'ForeName': 'Jovita', 'Initials': 'J', 'LastName': 'Balcaitiene', 'Affiliation': 'Global Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Gracies', 'Affiliation': 'EA 7377 BIOTN, Service de Rééducation Neurolocomotrice, Université Paris-Est Créteil, Hospital Albert Chenevier-Henri Mondor, Créteil, France.'}]",Clinical rehabilitation,['10.1177/0269215520911970']
195,32289571,A picture is worth a thousand words: The effect of viewing celebrity Instagram images with disclaimer and body positive captions on women's body image.,"Research has shown that exposure to Instagram images is harmful for women's body image. Although Instagram consists of photos of both peers and celebrities, the top followed Instagram accounts are held by thin and attractive female celebrities. The present study aimed to experimentally investigate whether two forms of Instagram caption could mitigate the detrimental effect of celebrity images on women's body image. Participants were 256 female undergraduate students who were assigned to view a set of celebrity images with either no caption, a disclaimer caption, or a body positive caption, or a control set of travel images. Results showed that exposure to celebrity images, in comparison to travel images, increased body dissatisfaction and decreased body appreciation. However, there was no significant effect of either form of caption. The effect of celebrity images was mediated by state appearance comparison and moderated by trait appearance comparison. It was concluded that the addition of disclaimer or body positive captions by attractive celebrities does not serve to improve women's body image.",2020,"Results showed that exposure to celebrity images, in comparison to travel images, increased body dissatisfaction and decreased body appreciation.","['Participants were 256 female undergraduate students', ""women's body image""]","['celebrity images with either no caption, a disclaimer caption, or a body positive caption, or a control set of travel images']",['body dissatisfaction and decreased body appreciation'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040802', 'cui_str': 'Travel'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",256.0,0.0238411,"Results showed that exposure to celebrity images, in comparison to travel images, increased body dissatisfaction and decreased body appreciation.","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Brown', 'Affiliation': 'Flinders University, Australia. Electronic address: zoe.brown@flinders.edu.au.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Flinders University, Australia.'}]",Body image,['10.1016/j.bodyim.2020.03.003']
196,32289741,Dulaglutide reduces binge episodes in type 2 diabetic patients with binge eating disorder: A pilot study.,"AIMS
Binge eating disorder (BED) is the most common eating disorder in the United States and Europe and is associated with obesity and type 2 diabetes (T2D). Presence and severity of BED have been associated with worse metabolic control and greater BMI in T2D patients. Glucagon Like Peptide-1 (GLP1) receptors are present in central nervous system areas involved in appetite regulation and treatment with GLP-1 receptor agonists modulates appetite and reward-related brain areas in humans. We evaluated the effects of treatment with dulaglutide on eating behavior in T2D outpatients with BED.
METHODS
This was a pilot open label, prospective controlled study. Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED. Patients were randomly assigned to receive either Dulaglutide 1,5 mg/sett or Gliclazide 60 mg for 12 weeks. We evaluated baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes after treatment. A multivariate linear regression model was used to verify the association between Δ BES from baseline with Δ Hba1c and variation of anthropometric parameters after treatment.
RESULTS
After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide. Reduction in BES was associated with reduction in body weight (p < 0.0001) and HbA1c (p = 0.033).
CONCLUSION
Dulaglutide treatment reduces binge eating behaviour in T2D patients with BED.",2020,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","['T2D patients', 'type 2 diabetic patients with binge eating disorder', 'T2D outpatients with BED', 'Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED', 'T2D patients with BED']","['Dulaglutide 1,5 mg/sett or Gliclazide', 'Dulaglutide treatment', 'dulaglutide', 'Dulaglutide', 'gliclazide']","['BMI', 'percentage fat mass', 'binge eating behaviour', 'binge episodes', 'baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes', 'Reduction in BES', 'eating behavior', 'body weight']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451027', 'cui_str': 'Binge eating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0375975,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Da Porto', 'Affiliation': 'Internal Medicine, University of Udine, Italy. Electronic address: daporto.andrea@gmail.com.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Casarsa', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Catena', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cavarape', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Sechi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.03.009']
197,32315869,Quality of life after switching from well-controlled vitamin K antagonist to direct oral anticoagulant: Little to GAInN.,"BACKGROUND
Direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA) prevent thromboembolism in atrial fibrillation (AF). DOAC have a fixed dosing regimen and obviate INR monitoring. Therefore, DOAC presumably affect quality of life (QoL) less than VKA. However, some VKA users appreciate the monitoring. A high time in the therapeutic range (TTR) leads to a lower impact on QoL. We assessed the influence of switching from well-controlled VKA to a DOAC on QoL.
METHODS
In the GAInN study, 241 patients with AF, a TTR ≥ 70%, and neither bleeding nor thrombosis while on VKA were randomised to switching to DOAC (n = 121) or continuing VKA (n = 120). Health-related (SF-36) and anticoagulation-related QoL (PACT-Q) was assessed at baseline and after six and twelve months of follow-up.
RESULTS AND CONCLUSION
SF-36 development did not differ between groups. After one year, average PACT-Q Convenience improvement was 2.5 (0.3-4.7) higher on DOAC. DOAC users were 6percentage points (95%CI -4-16) more likely to improve >5 points on Convenience; 22 pp. (95%CI 1-43) in patients who scored <95/100 at baseline. The probability to meaningfully improve on PACT-Q Satisfaction was 12 pp. (95%CI 0-25) higher on DOAC. However, 5 (4.1%) and 4 (3.3%) DOAC users resumed VKA because of side-effects and patient preference. Switching from well-controlled VKA to DOAC for AF leads to a higher probability of improved PACT-Q convenience and satisfaction, but also to a higher risk of side-effects. Arguably only patients who are not satisfied with VKA should switch, because they have more to gain by switching.",2020,DOAC users were 6percentage points (95%CI -4-16) more likely to improve >5 points on Convenience; 22 pp.,"['241 patients with AF, a TTR\xa0≥\xa070%, and neither bleeding nor thrombosis while on VKA']","['vitamin K antagonist to direct oral anticoagulant', 'continuing VKA', 'Direct oral anticoagulants (DOAC) and vitamin K antagonists (VKA']","['Health-related (SF-36) and anticoagulation-related QoL (PACT-Q', 'average PACT-Q Convenience improvement', 'quality of life (QoL', 'Quality of life', 'probability to meaningfully improve on PACT-Q Satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",241.0,0.12822,DOAC users were 6percentage points (95%CI -4-16) more likely to improve >5 points on Convenience; 22 pp.,"[{'ForeName': 'Jasper H A', 'Initials': 'JHA', 'LastName': 'van Miert', 'Affiliation': 'Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands. Electronic address: j.h.a.van.miert@umcg.nl.'}, {'ForeName': 'Hilde A M', 'Initials': 'HAM', 'LastName': 'Kooistra', 'Affiliation': 'Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands; Currently: Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Nic J G M', 'Initials': 'NJGM', 'LastName': 'Veeger', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Westerterp', 'Affiliation': 'Certe Thrombosis Service, Groningen, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Piersma-Wichers', 'Affiliation': 'Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Certe Thrombosis Service, Groningen, the Netherlands.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Meijer', 'Affiliation': 'Department of Hematology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]",Thrombosis research,['10.1016/j.thromres.2020.04.007']
198,32171422,"Rifampicin and clarithromycin (extended release) versus rifampicin and streptomycin for limited Buruli ulcer lesions: a randomised, open-label, non-inferiority phase 3 trial.","BACKGROUND
Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifampicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions.
METHODS
We did an open-label, non-inferiority, randomised (1:1 with blocks of six), multicentre, phase 3 clinical trial comparing fully oral RC8 with RS8 in patients with early, limited Buruli ulcer lesions. There were four trial sites in hospitals in Ghana (Agogo, Tepa, Nkawie, Dunkwa) and one in Benin (Pobè). Participants were included if they were aged 5 years or older and had typical Buruli ulcer with no more than one lesion (caterories I and II) no larger than 10 cm in diameter. The trial was open label, and neither the investigators who took measurements of the lesions nor the attending doctors were masked to treatment assignment. The primary clinical endpoint was lesion healing (ie, full epithelialisation or stable scar) without recurrence at 52 weeks after start of antimicrobial therapy. The primary endpoint and safety were assessed in the intention-to-treat population. A sample size of 332 participants was calculated to detect inferiority of RC8 by a margin of 12%. This study was registered with ClinicalTrials.gov, NCT01659437.
FINDINGS
Between Jan 1, 2013, and Dec 31, 2017, participants were recruited to the trial. We stopped recruitment after 310 participants. Median age of participants was 14 years (IQR 10-29) and 153 (52%) were female. 297 patients had PCR-confirmed Buruli ulcer; 151 (51%) were assigned to RS8 treatment, and 146 (49%) received oral RC8 treatment. In the RS8 group, lesions healed in 144 (95%, 95% CI 91 to 98) of 151 patients, whereas lesions healed in 140 (96%, 91 to 99) of 146 patients in the RC8 group. The difference in proportion, -0·5% (-5·2 to 4·2), was not significantly greater than zero (p=0·59), showing that RC8 treatment is non-inferior to RS8 treatment for lesion healing at 52 weeks. Treatment-related adverse events were recorded in 20 (13%) patients receiving RS8 and in nine (7%) patients receiving RC8. Most adverse events were grade 1-2, but one (1%) patient receiving RS8 developed serious ototoxicity and ended treatment after 6 weeks. No patients needed surgical resection. Four patients (two in each study group) had skin grafts.
INTERPRETATION
Fully oral RC8 regimen was non-inferior to RS8 for treatment of early, limited Buruli ulcer and was associated with fewer adverse events. Therefore, we propose that fully oral RC8 should be the preferred therapy for early, limited lesions of Buruli ulcer.
FUNDING
WHO with additional support from MAP International, American Leprosy Missions, Fondation Raoul Follereau France, Buruli ulcer Groningen Foundation, Sanofi-Pasteur, and BuruliVac.",2020,"Most adverse events were grade 1-2, but one (1%) patient receiving RS8 developed serious ototoxicity and ended treatment after 6 weeks.","['patients receiving RS8 and in nine (7%) patients receiving RC8', 'early Buruli ulcer lesions', '310 participants', 'patients with early, limited Buruli ulcer lesions', '297 patients had PCR-confirmed Buruli ulcer; 151 (51', 'Median age of participants was 14 years (IQR 10-29) and 153 (52%) were female', 'limited Buruli ulcer lesions', 'Participants were included if they were aged 5 years or older and had typical Buruli ulcer with no more than one lesion (caterories I and II) no larger than 10 cm in diameter', 'Between Jan 1, 2013, and Dec 31, 2017, participants were recruited to the trial', '332 participants', 'hospitals in Ghana (Agogo, Tepa, Nkawie, Dunkwa) and one in Benin (Pobè']","['rifampicin 10 mg/kg plus clarithromycin', 'RS8', 'oral rifampicin 10 mg/kg plus intramuscular streptomycin', 'Rifampicin and clarithromycin', 'oral RC8 treatment', 'rifampicin and streptomycin']","['efficacy and tolerability', 'adverse events', 'serious ototoxicity', 'lesion healing (ie, full epithelialisation or stable scar) without recurrence', 'intention-to-treat population', 'surgical resection', 'lesions healed', 'skin grafts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0085568', 'cui_str': 'Mycobacterium ulcerans Infection'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0442983', 'cui_str': 'Agogo (qualifier value)'}, {'cui': 'C0039533', 'cui_str': 'TEPA'}, {'cui': 'C0005005', 'cui_str': 'Dahomey'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235280', 'cui_str': 'Ototoxicity (disorder)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization (morphologic abnormality)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}]",332.0,0.107647,"Most adverse events were grade 1-2, but one (1%) patient receiving RS8 developed serious ototoxicity and ended treatment after 6 weeks.","[{'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Phillips', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi Centre for Collaborative Research in Tropical Medicine, Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Robert', 'Affiliation': ""Centre d'immunologie et des maladies infectieuses, Inserm, Sorbonne Université, Bactériologie site Pitié, AP-HP Sorbonne Université, Centre National de Référence des Mycobactéries, Paris, France.""}, {'ForeName': 'Kabiru Mohamed', 'Initials': 'KM', 'LastName': 'Abass', 'Affiliation': 'Agogo Presbyterian Hospital, Agogo, Ghana.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Thompson', 'Affiliation': 'Agogo Presbyterian Hospital, Agogo, Ghana.'}, {'ForeName': 'Fred Stephen', 'Initials': 'FS', 'LastName': 'Sarfo', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi Centre for Collaborative Research in Tropical Medicine, Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Tuah', 'Initials': 'T', 'LastName': 'Wilson', 'Affiliation': 'Nkawie-Toaso Government Hospital, Ghana.'}, {'ForeName': 'Godfred', 'Initials': 'G', 'LastName': 'Sarpong', 'Affiliation': 'Dunkwa Government Hospital, Dunkwa-on-Offin, Ghana.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gateau', 'Affiliation': ""Centre de diagnostic et de traitement de la lèpre et de l'Ulcère de Buruli Madeleine et Raoul Follereau, Ouémé-Plateau, Pobè, Bénin.""}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Chauty', 'Affiliation': ""Centre de diagnostic et de traitement de la lèpre et de l'Ulcère de Buruli Madeleine et Raoul Follereau, Ouémé-Plateau, Pobè, Bénin.""}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Omollo', 'Affiliation': 'Drugs for Neglected Diseases initiative, Africa Regional Office, Nairobi, Kenya.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ochieng Otieno', 'Affiliation': 'Drugs for Neglected Diseases initiative, Africa Regional Office, Nairobi, Kenya.'}, {'ForeName': 'Thaddaeus W', 'Initials': 'TW', 'LastName': 'Egondi', 'Affiliation': 'Drugs for Neglected Diseases initiative, Africa Regional Office, Nairobi, Kenya.'}, {'ForeName': 'Edwin O', 'Initials': 'EO', 'LastName': 'Ampadu', 'Affiliation': 'National Buruli ulcer Control Programme, Ghana Health Service, Accra, Ghana.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Agossadou', 'Affiliation': ""Programme National de Lutte contre la lèpre et l'Ulcère de Buruli, Cotonou, Benin.""}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Marion', 'Affiliation': ""Centre de recherche en cancérologie et immunologie Nantes-Angers, French National Institute of Health and Medical Research, Université d'Angers, Angers, France.""}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Ganlonon', 'Affiliation': ""Centre de diagnostic et de traitement de la lèpre et de l'Ulcère de Buruli Madeleine et Raoul Follereau, Ouémé-Plateau, Pobè, Bénin.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wansbrough-Jones', 'Affiliation': ""Institute of Infection and Immunity, St George's University of London, London, UK.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Grosset', 'Affiliation': 'Center for Tuberculosis Research, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Macdonald', 'Affiliation': 'Department of Dermatology & Cutaneous Surgery, Miller School of Medicine, University of Miami, Miami, FL, USA; Hospital Bernard Meys Project Medishare, Port-au-Prince, Haiti.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Treadwell', 'Affiliation': 'Institute for Advanced Wound Care, Montgomery, AL, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Saunderson', 'Affiliation': 'American Leprosy Missions, Greenville, SC, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Paintsil', 'Affiliation': 'Reconstructive and Plastic Surgery Unit, Korle-BU Teaching Hospital, Accra, Ghana.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Lehman', 'Affiliation': 'American Leprosy Missions, Greenville, SC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frimpong', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi Centre for Collaborative Research in Tropical Medicine, Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Nanaa Francisca', 'Initials': 'NF', 'LastName': 'Sarpong', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi Centre for Collaborative Research in Tropical Medicine, Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Saizonou', 'Affiliation': 'WHO, Country Office for Benin, Cotonou, Benin.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Tiendrebeogo', 'Affiliation': 'WHO, Regional Office for Africa, Brazzaville, Republic of the Congo.'}, {'ForeName': 'Sally-Ann', 'Initials': 'SA', 'LastName': 'Ohene', 'Affiliation': 'WHO, Country Office for Ghana, Accra, Ghana.'}, {'ForeName': 'Ymkje', 'Initials': 'Y', 'LastName': 'Stienstra', 'Affiliation': 'Department of Medicine/Infectious Diseases, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Kingsley B', 'Initials': 'KB', 'LastName': 'Asiedu', 'Affiliation': 'Department of Neglected Tropical Diseases, WHO, Geneva, Switzerland.'}, {'ForeName': 'Tjip S', 'Initials': 'TS', 'LastName': 'van der Werf', 'Affiliation': 'Department of Medicine/Infectious Diseases, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands. Electronic address: t.s.van.der.werf@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30047-7']
199,32392700,Evaluation of the Stomatognathic System before and after Osteopathic Manipulative Treatment in 120 Healthy People by Using Surface Electromyography.,"Objective: To investigate the action of osteopathic manipulative treatment on the muscular activity of the stomatognathic apparatus by using surface electromyography (sEMG). Material and Methods: Surface electromyography (sEMG) was performed on the masseter and anterior temporalis muscles of 120 subjects (73 F; 47 M), both at time T0 and T2. The sample was divided into three randomized groups of 40 subjects each: control, placebo, and osteopathic manipulative treatment (OMT). In the T1 interval between the two evaluations, the control group was not treated, the placebo group underwent a placebo treatment, and the OMT group underwent manipulative treatment. The mean value of each measurement and its coefficient of variation, between time T0 and T2, were calculated for both the intragroup (OMT, placebo, control) and the intergroup (OMT-placebo, OMT-control). Outcomes: In 40% of the subjects, statistically significant improvements were highlighted in the OMT. Whereas, the statistically significant results of the placebo and control groups were 7.5% and 17.5%, respectively, of which more than 75% moved away from the physiological range, showing a worsening of the muscular activity. This analysis showed statistically significant variations ( p ≤ 0.05) in the OMT group compared to the placebo and the control groups. Conclusions: OMT determines variations of the activity of masticatory muscles.",2020,This analysis showed statistically significant variations ( p ≤ 0.05) in the OMT group compared to the placebo and the control groups. ,"['120 Healthy People by Using Surface Electromyography', '40 subjects each']","['control, placebo, and osteopathic manipulative treatment (OMT', 'Surface electromyography (sEMG', 'OMT', 'osteopathic manipulative treatment', 'placebo']",['OMT'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}]",[],120.0,0.05336,This analysis showed statistically significant variations ( p ≤ 0.05) in the OMT group compared to the placebo and the control groups. ,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Manzotti', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Viganoni', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Lauritano', 'Affiliation': 'Department of Medicine and Surgery, Centre of Neuroscience of Milan, University of Milano-Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bernasconi', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Paparo', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Rachele', 'Initials': 'R', 'LastName': 'Risso', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Nanussi', 'Affiliation': 'Department of Medicine and Surgery, Centre of Neuroscience of Milan, University of Milano-Bicocca, 20126 Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17093250']
200,32394723,"Effects of Depot Medroxyprogesterone Acetate, Copper Intrauterine Devices, and Levonorgestrel Implants on Early HIV Disease Progression.","Limited data exist on the effects of contraceptives on HIV disease progression. We studied the association between intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (IUD), and the levonorgestrel (LNG) implant on markers of HIV disease progression at the time of HIV detection and 3 months postdetection and time from detection to CD4 count <350 cells/mm 3 . Among women initiating antiretroviral therapy (ART), we studied the effect of contraceptive group on time from ART initiation to viral load (VL) <40 copies/mL. We included women 16-35 years randomized to DMPA-IM, copper IUD, or LNG implant with incident HIV infection during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial ( n = 382). We analyzed HIV VL and CD4 cell count according to participants' randomized method and also conducted a ""continuous use"" analysis that excluded follow-up time after method discontinuation. We used adjusted linear models to compare mean VL and CD4 cell levels by contraceptive group up to the time of ART initiation. We compared time from HIV detection to CD4 count <350 cells/mm 3 and, following ART initiation, time to viral suppression (VL <40 copies/mL) using Cox proportional hazards models. At HIV detection, women allocated to DMPA-IM had lower VL relative to copper IUD (-0.28 log 10 copies/mL; 95% confidence interval [CI]: -0.55 to -0.01) and LNG implant (-0.27, CI: -0.55 to 0.02) and higher mean CD4 than copper IUD users by 66 cells/mm 3 (CI: 11-121). In continuous use analyses women allocated to DMPA-IM progressed to CD4 < 350 cells/mm 3 slower than copper IUD users (hazard ratio [HR] = 0.6, CI: 0.3-1.1), whereas copper IUD users progressed faster than LNG implant users (HR = 1.8, CI: 1.0-3.3). Time to viral suppression was faster for DMPA-IM than copper IUD (HR = 1.5, CI: 1.0-2.3) and LNG implant 1.4 (CI: 0.9-2.2) users. We found no evidence of more rapid early HIV disease progression among women using DMPA-IM than among women using copper IUD or LNG implant. Our finding of more rapid progression among copper IUD compared with DMPA-IM users should be interpreted cautiously.",2020,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","['women using DMPA-IM', 'women 16-35 years randomized to']","['DMPA-IM, copper IUD, or levonorgestrel implant', 'DMPA-IM, the copper IUD and levonorgestrel (LNG) implant', 'depot medroxyprogesterone acetate, copper intrauterine devices, and levonorgestrel implants']","['mean viral load and CD4 cell levels', 'time to viral suppression', 'VL relative to copper IUD', 'HIV viral load and CD4 cell count', 'early HIV disease progression', 'time to CD4 count <350 cells/mm3 and viral suppression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0039215', 'cui_str': 'T lymphocyte positive for CD4 antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}]",382.0,0.424447,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","[{'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Morrison', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'G Justus', 'Initials': 'GJ', 'LastName': 'Hofmeyr', 'Affiliation': 'Effective Care Research Unit, Department of Obstetrics and Gynaecology, University of Witwatersrand/Fort Hare/Walter Sisulu, East London, South Africa.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rees', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), University of Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Philip', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), University of Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nanda', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Gonasagrie', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': 'Emavundleni Research Center, Capetown, South Africa.'}, {'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'KEMRI-RCTP Study Center, Kisumu, Kenya.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mastro', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Vinodh', 'Initials': 'V', 'LastName': 'Edward', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Deese', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynecology, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Beesham', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynecology, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Center, Soshanguve, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS research and human retroviruses,['10.1089/AID.2020.0015']
201,32392381,Early parenting intervention promotes 24-month psychomotor development in preterm children.,"AIM
Although parenting is key to promoting healthy development of at-risk preterm infants, parents have often restricted access to neonatal intensive care units (NICUs). This study aimed to assess the effect of an early parenting intervention on the psychomotor outcome in preterm children at 24 months of corrected age.
METHODS
Forty-two preterm children and their parents were consecutively recruited at a level III NICU in Northern Italy and randomly allocated to early intervention (two educational peer-group sessions and four individual infant observation sessions) or care as usual (no educational or infant observation sessions). During NICU stay, parents provided information on daily holding and skin-to-skin. Psychomotor development was measured at 24 months of corrected age using the Griffith Mental Development Scales.
RESULTS
There were no significant differences in socio-demographic and clinical variables between early intervention (n = 21; 13 females) and care as usual (n = 21; 12 females) groups. At 24 months of corrected age, children in the early intervention arm had greater scores for global psychomotor development as well as for Hearing-Speech and Personal-Social sub-scales, compared to those in the care as usual group.
CONCLUSION
The present NICU parenting intervention was found to be associated with better psychomotor outcomes in preterm children at 24-month age. The effects were especially evident for domains related to language and socio-emotional functioning. Results are promising and should be retested with more heterogeneous and representative preterm sample.",2020,There were no significant differences in socio-demographic and clinical variables between early intervention (n = 21; 13 females) and care as usual (n = 21; 12 females) groups.,"['preterm children at 24 months corrected age', 'preterm children at 24-month-age', 'Forty-two preterm children and their parents were consecutively recruited at a level III NICU in Northern Italy and randomly allocated to', 'preterm children']","['NICU parenting intervention', 'early parenting intervention', 'Early parenting intervention', 'early intervention (two educational peer-group sessions and four individual infant observation sessions) or care as usual (no educational or infant observation sessions']","['socio-demographic and clinical variables', 'global psychomotor development as well as for Hearing-Speech and Personal-Social sub-scales', 'language and socio-emotional functioning', 'Psychomotor development']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392358', 'cui_str': 'Psychomotor development'}, {'cui': 'C0423539', 'cui_str': 'Finding of ability to hear voice'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",42.0,0.0345804,There were no significant differences in socio-demographic and clinical variables between early intervention (n = 21; 13 females) and care as usual (n = 21; 12 females) groups.,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Pisoni', 'Affiliation': 'NICU, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Provenzi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Moncecchi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Caporali', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Naboni', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Stronati', 'Affiliation': 'NICU, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Montirosso', 'Affiliation': '0-3 Center for the at-Risk Infant, Scientific Institute IRCCS E. Medea, Lecco, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Borgatti', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Orcesi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15345']
202,32396510,[Surgical Treatment of Clavicle Midshaft Fractures - Prospective Randomized Trial].,"PURPOSE OF THE STUDY Comparison of the outcomes of clavicle midshaft fractures using two different surgical techniques, namely intramedullar osteosynthesis using elastic stable intramedullary nailing (ESIN) with medial cap and extramedullar plate osteosynthesis. MATERIAL AND METHODS The prospective randomized trial was conducted at the Department of Trauma Surgery of the Department of Surgery of the University Hospital Hradec Králové in the Czech Republic at the Level I Trauma Center between 2014 and 2018 and compared two types of osteosynthesis of clavicle midshaft fractures. 60 patients were enrolled in the study and were randomly assigned to one of the two groups. In Group 1, the participants were treated by ESIN and in Group 2 by plate osteosynthesis. The operative technique was chosen by the sealed envelope method. According to the randomization list created by a specialised statistical company, every envelope was marked with a unique number and contained the intramedullar ""IM"", or the extramedullar ""EM"" sign. RESULTS The observation of statistical parameters by unpaired t test detected significantly different results: a shorter incision using ESIN osteosynthesis (median = 2.9 cm) compared with plate osteosynthesis (median 14 cm, p < 0.001), longer X-ray exposure using ESIN (median = 325 s) compared with plate osteosynthesis (median = 16.5 s, p < 0.001) and radiation dose using ESIN (median = 996 cGy/cm2) compared with plate osteosynthesis (median = 4 cGy/cm2, p < 0.001). The difference in other parameters such as operative time, in-patient length of stay and duration of rehabilitation was not statistically significant. The time to clavicle fracture repair was comparable in both the surgical arms, i.e. approximately 3 months. Also, the duration of incapacity for work was not statistically different. Functional Constant Shoulder Score at a one-year followup is comparable in both the two arms (p = 0.268). The Dunn s method necessitated a longer operative time when treating multifragmental midshaft clavicle fracture by the ESIN compared to simple fractures. No statistically significant difference was detected in the operative time of different procedures and in the number of bone fragments. The functional outcome was excellent in 25 patients (83%) in each method. DISCUSSION Most midshaft clavicle fractures are still treated non-operatively with good outcomes. The indication for surgical treatment is the dislocation of fragments greater than the width of the clavicle bone, the shortening of fragments greater than 2 cm and the angulation of more than 30°. Patient after operative treatment profits from bone healing by absolute or relative stability. In recent years, new intramedullar techniques other than open plate reduction and fixation have emerged. For example, elastic stable intramedullary titan nailing. Both the methods are full-fledged without functional differences in longterm follow-up. CONCLUSIONS We consider the intramedullar osteosynthesis to be the most appropriate surgical approach for simple midshaft spiral, oblique and transverse clavicle fractures and also wedge oblique fractures. Plate osteosynthesis is useful for all types of fractures. No statistically significant difference in the rate of bone healing was observed after intramedullar or extramedullar ostesynthesis, but multifragmentary fractures healed faster when plate osteosynthesis was used. The determining factor for the received radiation dose is solely the surgical method, not the type of fracture. There is a statistically significant difference in shorter X-ray exposure and lower received radiation dose in plate fixation and reduction. The complication rate is comparable in both the methods. Key words: elastic stable intramedullary nailing, midshaft clavicle fracture, ESIN, TEN, titan elastic nail, clavicle plate osteosynthesis, 3.5 LCP clavicular plate, indication for midshaft fracture treatment.",2020,"No statistically significant difference in the rate of bone healing was observed after intramedullar or extramedullar ostesynthesis, but multifragmentary fractures healed faster when plate osteosynthesis was used.","['Department of Trauma Surgery of the Department of Surgery of the University Hospital Hradec Králové in the Czech Republic at the Level', '60 patients were enrolled in the study']","['surgical techniques, namely intramedullar osteosynthesis using elastic stable intramedullary nailing (ESIN) with medial cap and extramedullar plate osteosynthesis', 'ESIN', 'elastic stable intramedullary titan nailing', 'Plate osteosynthesis']","['operative time, in-patient length of stay and duration of rehabilitation', 'bone healing by absolute or relative stability', 'rate of bone healing', 'Functional Constant Shoulder Score', 'duration of incapacity for work', 'time to clavicle fracture repair', 'operative time', 'complication rate', 'number of bone fragments', 'shorter X-ray exposure']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4727954', 'cui_str': 'Plate osteosynthesis'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0242756', 'cui_str': 'Titan'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3698366', 'cui_str': 'Bone fragment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",60.0,0.0237448,"No statistically significant difference in the rate of bone healing was observed after intramedullar or extramedullar ostesynthesis, but multifragmentary fractures healed faster when plate osteosynthesis was used.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Šimek', 'Affiliation': 'Katedra vojenské chirurgie, Fakulta vojenského zdravotnictví, Univerzita obrany v Brně, Hradec Králové.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Šmejkal', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frank', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hyšpler', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dědek', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Páral', 'Affiliation': ''}]",Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca,[]
203,32334332,The effects of consecutive sessions of anodal transcranial direct current stimulation over the primary motor cortex on hand function in healthy older adults.,"BACKGROUND
With advancing age, changes in the central nervous system may lead to motor functional deficits. Non-invasive brain stimulation techniques are suggested to help modifying brain function.
OBJECTIVES
The aim of the current study was to investigate the effect of using multi session anodal transcranial Direct Current Stimulation (a-tDCS) over the primary motor cortex (M1) on the hand function in healthy older adults.
METHOD
In this randomized, double-blinded, sham-controlled study 32 participants received active or sham a-tDCS (1 mA, 20 min, for five consecutive days) and performed the Purdue Pegboard Test (PPT) on the first day before tDCS application, immediately (T1), 30 min (T2), and one week after the last session (5th day) (T3) of the stimulation.
RESULTS
There was a significant improvement for PPT (p < 0.05) in a-tDCS group at all post-test values except for PPT for left hand (PPTL) at T1. Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
CONCLUSION
The current findings suggest a-tDCS can be considered as a promising stand-alone technique in the intervention of the age-related decline of manual dexterity for improving hand function.",2020,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","['32 participants received', 'healthy older adults']","['multi session anodal transcranial Direct Current Stimulation (a-tDCS', 'active or sham a-tDCS', 'anodal transcranial direct current stimulation']","['PPT', 'PPT subtests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}]",32.0,0.0611213,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: zmosallanezhad@yahoo.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Speech Therapy Department, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Health and Rehabilitation Sciences Program, University of Western Ontario, London, Canada.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104063']
204,32336211,Effects of a High-Intensity Progressive-Cycle Program on Quality of Life and Motor Symptomatology in a Parkinson's Disease Population: A Pilot Randomized Controlled Trial.,"The benefits of aerobic exercise in persons with Parkinson's disease (PD) have been widely studied. Recent studies support the use of high-intensity aerobic exercise to improve oxidative stress values and functional performance in PD patients. The aim of this study is ascertain whether high-intensity aerobic training with lower extremity cycle ergometers and balance training can improve motor symptoms and quality of life in a PD population of Hoehn and Yahr disability score 1-3. The intervention took place in rehabilitation centers in secondary care. A pilot randomized controlled trial was carried out with 14 outpatients participated in the 8-week study. They were composed of a control group (CG; n = 7) that followed a balance protocol and an experimental group (EG; n = 7) that performed high-intensity (70% heart rate reserve) aerobic workout using a lower extremity cycle ergometer and a balance protocol once a week. The primary outcome measures included the 8-Foot Up-and-Go test, 6-Minute Walk test, 2-Minute Step test, Parkinson's Disease Questionnaire (PDQ39), Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Tinetti test. Significant improvements in the PDQ39 ( F 1.23 = 3.102; sig = 0.036), the MDS-UPDRS III ( F 1.23 = 4.723; sig = 0.033), and MDS-UPDRS Total ( F 1.23 = 4.117; sig = 0.047) were observed in the EG as against the CG. After taking into account the number of subjects in each group, the results suggest that the PD population can withstand high-intensity aerobic workouts with a lower extremity cycle ergometer. This exercise is a beneficial therapy for them because it reduces motor symptoms of the disease and furthermore increases and improves patient's quality of life.",2020,"RESULTS
Significant improvements in the PDQ39 (F1.23= 3.102; sig=0.036), the MDS-UPDRS III (F1.23= 4.723; sig=0.033) and total","['a PD population of Hoehn &Yahr (H&Y) disability score 1-3', 'Rehabilitation centers in secondary care', 'A total of 14 outpatients participated in the 8-week study', ""a Parkinson's disease population"", ""persons with Parkinson's disease (PD""]","['high-intensity aerobic exercise', 'aerobic exercise', 'high-intensity aerobic training with lower extremity cycle ergometers and balance training', 'high-intensity progressive-cycle program', 'balance protocol and an experimental group (n=7) that performed high-intensity (70% heart rate reserve) aerobic workout using an lower extremity cycle ergometer and a balance protocol once a week']","['PDQ39', 'motor symptoms and quality of life', ""8-Foot Up and Go test, 6-minute walk test, 2-minute step test, Parkinson Disease Questionnaire-39 (PDQ39), Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Tinetti test"", 'quality of life and motor symptomatology', 'oxidative stress values and functional performance']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",14.0,0.0704685,"RESULTS
Significant improvements in the PDQ39 (F1.23= 3.102; sig=0.036), the MDS-UPDRS III (F1.23= 4.723; sig=0.033) and total","[{'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Cancela', 'Affiliation': 'Faculty of Education and Sport Science, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'Irimia', 'Initials': 'I', 'LastName': 'Mollinedo', 'Affiliation': 'Faculty of Education and Sport Science, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Montalvo', 'Affiliation': 'Faculty of Education and Sport Science, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'María Elena', 'Initials': 'ME', 'LastName': 'Vila Suárez', 'Affiliation': 'Faculty of Education and Sport Science, University of Vigo, Pontevedra, Spain.'}]",Rejuvenation research,['10.1089/rej.2019.2267']
205,32299024,"A double-blind, randomized controlled trial of duloxetine for pain in Parkinson's disease.","BACKGROUND
Duloxetine proved effective for treating pain in people with Parkinson's disease in a single-arm, open-label study.
OBJECTIVE
To evaluate the efficacy of duloxetine in a double-blind, randomized, placebo-controlled trial.
METHODS
We randomly assigned 46 patients with Parkinson's disease with pain to either the duloxetine 40 mg/day arm or the placebo arm. After 10 weeks, we tested the change from baseline in 24-hour average pain severity measured by a visual analogue scale.
RESULTS
We could not confirm the effect of duloxetine on pain. Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
CONCLUSIONS
The study failed to provide evidence for the use of duloxetine for treating pain in people with Parkinson's disease.",2020,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[""people with Parkinson's disease in a single-arm, open-label study"", ""pain in Parkinson's disease"", ""people with Parkinson's disease"", ""46 patients with Parkinson's disease with pain to either the""]","['duloxetine', 'placebo', 'Duloxetine', 'duloxetine 40\xa0mg/day arm or the placebo']","['24-hour average pain severity measured by a visual analogue scale', ""Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39"", 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1576942', 'cui_str': 'duloxetine 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",46.0,0.692206,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Laboratory of Neurogenetics, National Institute on Aging, National Institute of Health, MD, USA; Data Tecnica International, MD, USA.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tada', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neurology, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Tsujii', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Miyaue', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nagai', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Imabari Hospital, Ehime, Japan. Electronic address: nomoto1492@nifty.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116833']
206,32193169,Visual and cognitive processing of thin-ideal Instagram images containing idealized or disclaimer comments.,"Recent studies have demonstrated that exposure to thin-ideal social media content is associated with decreased body satisfaction, and disclaimer comments have been a proposed intervention. This experiment uses eye-tracking methods to explore the effect of disclaimer comments on participants' processing of thin-ideal Instagram images. Women ages 18-35 (N = 181) were randomly assigned to view thin-ideal Instagram images paired with one of two caption types: traditional comments that idealized the images, or disclaimer comments that critiqued the images as unrealistic. Participants' eye movements were tracked during viewing. Following exposure, participants reported their anxiety about specific body regions, as well as their perceptions of social pressure for thinness. Post-test body anxiety and perceived pressure for thinness did not differ based on experimental condition. Results indicated some differences in message processing, with similar visual attention to the model across conditions but greater attention to the comment in the disclaimer condition. Attention to the model's thighs was associated with increased body anxiety about the thighs in both conditions, whereas attention to the model's waist was associated with increased body anxiety about the waist only in the Idealized Comment condition. This indicates that the disclaimer comments were somewhat, but not entirely, effective.",2020,"Results indicated some differences in message processing, with similar visual attention to the model across conditions but greater attention to the comment in the disclaimer condition.","['Women ages 18-35 (N = 181', ""participants' processing of thin-ideal Instagram images""]","['view thin-ideal Instagram images paired with one of two caption types: traditional comments that idealized the images, or disclaimer comments that critiqued the images as unrealistic']","['Visual and cognitive processing', 'body anxiety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0282411', 'cui_str': 'Commentary'}, {'cui': 'C0010341', 'cui_str': 'Critique'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",181.0,0.0172846,"Results indicated some differences in message processing, with similar visual attention to the model across conditions but greater attention to the comment in the disclaimer condition.","[{'ForeName': 'Amelia C', 'Initials': 'AC', 'LastName': 'Couture Bue', 'Affiliation': 'Communication Studies, University of Michigan, United States. Electronic address: ameliacc@umich.edu.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Communication Studies, University of Michigan, United States.'}]",Body image,['10.1016/j.bodyim.2020.02.014']
207,32208176,The effects of short-term moderate intensity aerobic exercise and long-term detraining on electrocardiogram indices and cardiac biomarkers in postmenopausal women.,"OBJECTIVE
The purpose of this study was to investigate the effects of 12-week of moderate-intensity aerobic exercise and 5-month detraining on electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P) in postmenopausal women (PMWs).
MATERIALS AND METHODS
Thirty-one PMWs (aged 50-70 yrs) were randomized to exercise (EX, n = 16) and control (C, n = 15) groups. EX group performed of 12-week of warm up- walking/jogging moderate intensity aerobic exercise training program- recovery (60 min/day, 3 days/week at 70% of maximal heart rate reserve), and then 5-month detraining remained. C group maintain their normal lifestyle during 8 months. The ECG indices and cardiac serum levels were measured at baseline, after 12-week exercise, and after 5-month detraining.
RESULTS
After 12-week exercise intervention, P-R interval, serum PTH and serum Vit D were significantly increased in the EX group compared to the C group (P = 0.020, P = 0.001 and P = 0.001, respectively). After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
CONCLUSIONS
The results suggested that 12-week of moderate intensity aerobic exercise increased the P-R interval, PTH and Vit D, as severe Vit D deficiency status (below 10 ng/ml) improved to Vit D deficiency status (between 10 and 20 ng/ml) in PMWs. Also, long-term positive adaptations to aerobic exercise such as increased Vit D were observed even after 5-month detraining. In addition, P-R segment and S-T interval decreased after 5-month detraining in sedentary PMWs, which may be a sign of atrial positive adaptations to aerobic exercise.",2020,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
","['postmenopausal women (PMWs', 'postmenopausal women', 'Thirty-one PMWs (aged 50-70\xa0yrs']","['warm up- walking/jogging moderate intensity aerobic exercise training program- recovery', 'exercise (EX', 'short-term moderate intensity aerobic exercise and long-term detraining', 'moderate-intensity aerobic exercise and 5-month detraining', 'moderate intensity aerobic exercise']","['Vit D', 'electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P', 'ECG indices and cardiac serum levels', 'electrocardiogram indices and cardiac biomarkers', 'P-R interval, serum PTH and serum Vit D', 'serum Vit D', 'Vit D deficiency status', 'P-R segment and S-T interval', 'P-R interval, PTH and Vit D, as severe Vit D deficiency status']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0596235', 'cui_str': 'Ca 2+'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0520879', 'cui_str': 'P-R segment, function (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0251744,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Malandish', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: malandish@gmail.com.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Exercise Physiology, Department of Sport Injuries & Corrective Exercises, Faculty of Physical Education & Sport Sciences, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sheikhlou', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Afsargharehbagh', 'Affiliation': 'Fellowship of Balloon Angioplasty, Department of Interventional Cardiology, Shohada Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Clinical Biochemistry, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.004']
208,31002955,Randomized trial evaluating the role of weight loss in overweight and obese men with early stage prostate Cancer on active surveillance: Rationale and design of the Prostate Cancer Active Lifestyle Study (PALS).,"Active surveillance (AS) is increasingly used to monitor patients with low-risk prostate cancer; however, approximately 50% of AS patients experience disease reclassification requiring definitive treatment and little is known about patient characteristics that modify the risk of reclassification. Obesity may be one of the major contributing factors. The Prostate Cancer Active Lifestyle Study (PALS) is a clinical trial evaluating the impact of weight loss among overweight/obese (Body Mass Index (BMI) ≥ 25 kg/m 2 ) men with clinically localized prostate cancer on AS. Two hundred participants will be randomized to either the PALS intervention, a 6-month structured diet and exercise program adapted from the Diabetes Prevention Program followed by 6 months of maintenance, or control (general diet and physical activity guidelines delivered in a single session). The PALS intervention involves one-on-one instruction with a registered dietitian and exercise physiologist to achieve the study goal of loss of 7% of baseline weight. Participation is coordinated so that the 6-month time point coincides with the participants' standard-of-care AS prostate biopsy. Primary outcomes will evaluate the intervention effects on circulating and tissue markers of glucose and insulin regulation, health-related quality of life and pathologic upgrading on follow-up prostate biopsies. Additional analyses will determine whether changes in weight and glucose regulation can be sustained for 6 months after the end of instruction. Findings from this trial may have wide reaching implications for men diagnosed with clinically-localized prostate cancer by providing an active lifestyle-based approach to improve prostate cancer patient outcomes.",2019,Findings from this trial may have wide reaching implications for men diagnosed with clinically-localized prostate cancer by providing an active lifestyle-based approach to improve prostate cancer patient outcomes.,"['≥\u202f25\u202fkg/m 2 ) men with clinically localized prostate cancer on AS', 'overweight/obese (Body Mass Index (BMI', 'men diagnosed with clinically-localized prostate cancer', 'overweight and obese men with early stage prostate Cancer on active surveillance', 'Two hundred participants', 'patients with low-risk prostate cancer']","['structured diet and exercise program adapted from the Diabetes Prevention Program followed by 6\u202fmonths of maintenance, or control (general diet and physical activity guidelines delivered in a single session', 'PALS intervention']","['weight and glucose regulation', 'weight loss', 'circulating and tissue markers of glucose and insulin regulation, health-related quality of life and pathologic upgrading on follow-up prostate biopsies']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0301563', 'cui_str': 'General diet (finding)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",200.0,0.0499012,Findings from this trial may have wide reaching implications for men diagnosed with clinically-localized prostate cancer by providing an active lifestyle-based approach to improve prostate cancer patient outcomes.,"[{'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Schenk', 'Affiliation': 'Fred Hutchinson Cancer Research Center, United States. Electronic address: jschenk@fredhutch.org.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Fred Hutchinson Cancer Research Center, United States.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Beatty', 'Affiliation': 'Fred Hutchinson Cancer Research Center, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'VanDoren', 'Affiliation': 'Fred Hutchinson Cancer Research Center, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Lin', 'Affiliation': 'Fred Hutchinson Cancer Research Center, United States; University of Washington, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Porter', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System, United States; University of Washington, United States.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Gore', 'Affiliation': 'University of Washington, United States.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Gulati', 'Affiliation': 'Fred Hutchinson Cancer Research Center, United States.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Plymate', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System, United States.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Wright', 'Affiliation': 'Fred Hutchinson Cancer Research Center, United States; Veterans Affairs Puget Sound Health Care System, United States; University of Washington, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.04.004']
209,32338468,Randomized Controlled Trial: The effects of Short Message Service on mothers' oral health knowledge and practice.,"OBJECTIVE
Mobile health has provided an effective means to educate, empower, and provide access to health services for individuals and groups. This study aimed to compare the effects of gain-frame and loss-frame SMS on the knowledge and practice of mothers with children under the age of six years regarding pediatric oral health.
RESEARCH DESIGN
This randomized controlled trial was conducted in kindergartens and preschool centers of Shiraz, Iran in 2016. There were 71 mothers in the gain-frame group, 66 in the loss-frame group and 74 in the control group. The data were collected before and three-four weeks after the intervention. Data analysis used descriptive statistics, independent t-test, ANOVA, Pearson correlation test, ANCOVA, and post-hoc LSD test (Least Significant Difference).
RESULTS
There was a significant difference between the control (8.83±2.03) and gain-frame (11.8±2.17, p⟨0.001) and loss-frame (12.09±1.94, p⟨0.001) groups for post-test knowledge scores. A difference was also observed between the control group (56.27±11.53) and gain-frame (60.8±7.77, p⟨0.001) and loss-frame (60.25±8.96, p⟨0.001) groups for post-test practice scores. No difference was found between the gain-frame and loss-frame groups for the post-test scores (p=0.69).
CONCLUSION
Gain-frame and loss-frame SMS had similar impacts on the mothers' knowledge and practices about their children's oral health. However, both improved the mothers' knowledge and practice. Therefore, regardless of the style of text message framing, this method may be useful for educating mothers.",2020,"No difference was found between the gain-frame and loss-frame groups for the post-test scores (p=0.69).
","[""mothers' oral health knowledge and practice"", 'kindergartens and preschool centers of Shiraz, Iran in 2016', 'mothers with children under the age of six years regarding pediatric oral health', '71 mothers in the gain-frame group, 66 in the loss-frame group and 74 in the control group']","['Short Message Service', 'gain-frame and loss-frame SMS']","['loss-frame', 'gain-frame']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]","[{'cui': 'C0080089', 'cui_str': 'Reading Frames'}]",,0.124533,"No difference was found between the gain-frame and loss-frame groups for the post-test scores (p=0.69).
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Khademian', 'Affiliation': 'PhD Candidate, Student Research Committee, School of Management and Medical Informatics, Department of Health Information Management, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rezaee', 'Affiliation': 'Associate Professor, Clinical Education Research Center, Health Human Resources Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Pournik', 'Affiliation': 'MD, MPH, MBA, PhD of Health Informatics Psychosocial Health Research Institute, Iran University of Medical Sciences, Tehran, Iran; Department of Community Medicine, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]",Community dental health,['10.1922/CDH_4642Rezaee07']
210,31157881,Multiple Health Risk Behaviors in Young Adult Smokers: Stages of Change and Stability over Time.,"BACKGROUND
Health risk behaviors (HRBs) are common, yet not well understood in young adult smokers.
PURPOSE
We examined HRB profiles over 12 months in young adult smokers participating in a Facebook smoking cessation intervention clinical trial.
METHODS
Participants (N = 500; age M = 20.9 years; 54.6% women) were recruited online and randomized to receive either a 3-month Facebook smoking cessation intervention or referral to Smokefree.gov (control). A Health Risk Assessment determined risk for 10 behaviors at baseline and 3, 6, and 12 months. Latent class analysis (LCA) and latent transition analysis (LTA) were used to identify patterns of HRBs and changes over time.
RESULTS
At baseline, participants reported an average of 5.4 (standard deviation [SD] = 1.7) risk behaviors, including smoking (100%), high-fat diet (84.8%), poor sleep hygiene (71.6%), and low fruit and vegetable intake (69.4%). A 3-class model fit the data best at baseline and all follow-up time points: low risk (28.8% at baseline) with low likelihood of risk on all behaviors except smoking, substance use risk (14.0% at baseline) characterized by heavy episodic drinking, cannabis use, and other illicit drug use, and metabolic risk (57.2% at baseline), with a high percentage of members at risk for a low fruit and vegetable intake, high-fat diet, inactivity, stress, and poor sleep hygiene. Classes were very stable at 3, 6, and 12 months, with few participants transitioning between classes.
CONCLUSIONS
Most young adult smokers engaged in multiple risk behaviors, with meaningful clustering of behaviors, and demonstrated stability over a year's time. In addition to smoking, targets for intervention are co-occurring substance use and metabolic risk behaviors.
CLINICAL TRIALS REGISTRATION
NCT02207036.",2020,"CONCLUSIONS
Most young adult smokers engaged in multiple risk behaviors, with meaningful clustering of behaviors, and demonstrated stability over a year's time.","['Young Adult Smokers', 'young adult smokers', 'Participants (N = 500; age M = 20.9 years; 54.6% women', 'young adult smokers participating in a Facebook smoking cessation intervention clinical trial']",['Facebook smoking cessation intervention or referral to Smokefree.gov (control'],"['poor sleep hygiene', 'heavy episodic drinking, cannabis use, and other illicit drug use, and metabolic risk', 'Latent class analysis (LCA) and latent transition analysis (LTA', 'Multiple Health Risk Behaviors']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0281875', 'cui_str': 'Illicit drug use (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2729610', 'cui_str': 'LTA'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C4505097', 'cui_str': 'Health Risk Behaviors'}]",500.0,0.0288638,"CONCLUSIONS
Most young adult smokers engaged in multiple risk behaviors, with meaningful clustering of behaviors, and demonstrated stability over a year's time.","[{'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, Suite, San Francisco, CA, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Vogel', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, Suite, San Francisco, CA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, Suite, San Francisco, CA, USA.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz025']
211,32151992,#Loveyourbody: The effect of body positive Instagram captions on women's body image.,"One increasing trend on social media is the posting of body positive content that aims to challenge narrow beauty ideals and instead promote acceptance and appreciation of all bodies. The aim of the present study was to experimentally investigate the effect of body positive captions attached to Instagram images on young women's body image. Participants were 384 women aged 18-30 years randomly assigned to view Instagram images of thin or average-sized women containing either body positive captions or no captions. In contrast to prediction, the body positive captions had no effect on body dissatisfaction or body appreciation. There was a significant effect of image type, whereby the average images resulted in less body dissatisfaction and greater body appreciation than the thin images. A significant three-way interaction indicated that for women high on thin-ideal internalisation, body positive captions on average images led to greater body appreciation, but lower body appreciation when attached to thin images. The results suggest that the visual imagery of an Instagram post is a more potent contributor to body image than any accompanying text. Presenting a more diverse array of women's bodies on social media is likely a more effective way to foster body satisfaction and appreciation.",2020,"There was a significant effect of image type, whereby the average images resulted in less body dissatisfaction and greater body appreciation than the thin images.","['Participants were 384 women aged 18-30 years randomly assigned to', ""young women's body image"", ""women's body image""]","['body positive captions attached to Instagram images', 'Loveyourbody', 'view Instagram images of thin or average-sized women containing either body positive captions or no captions', 'body positive Instagram captions']","['body dissatisfaction and greater body appreciation', 'body dissatisfaction or body appreciation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",384.0,0.0408839,"There was a significant effect of image type, whereby the average images resulted in less body dissatisfaction and greater body appreciation than the thin images.","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Flinders University, Australia. Electronic address: Marika.Tiggemann@flinders.edu.au.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Anderberg', 'Affiliation': 'Flinders University, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Brown', 'Affiliation': 'Flinders University, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.015']
212,32155576,Effect of intensive self-management education on seizure frequency and quality of life in epilepsy patients with prodromes or precipitating factors.,"PURPOSE
To explore the impact of an intensive self-management education strategy on seizure frequency and quality of life in patients with epileptic seizures with prodromes or precipitating factors. The intensive self-management education included monthly education sessions on prodromes and precipitating factors aiming to help patients to adopt self-management strategies.
METHODS
Adult patients with epilepsy (PWE) able to identify prodromes or precipitating factors of their seizures were randomly assigned to an intensive education group (IEG) (n = 45) or a regular education group(REG) (n = 47). All patients received a single face-to-face self-management education session at the time of enrollment. Both groups of patients received monthly telephone follow-up for 1 year. PWE in the IEG received intensive education during each follow-up call. Primary outcomes were seizure frequency, quality of life(Quality of life in epilepsy-31 inventory scores, QOLIE 31), and drug adherence(Morisky medication adherence scale,MMAS).
RESULTS
At the end of the 1-year follow-up period, seizure frequency in the IEG was significantly lower than at baseline (p < 0.001), but not in the REG(p = 0.085). Quality of life had improved significantly in the IEG (p < 0.001), but not in the REG (p = 0.073). Drug adherence was better in the IEG than in the REG (p = 0.003), and there were fewer accidental injuries in the IEG than the REG (p = 0.031).
CONCLUSIONS
In PWE aware of seizure prodromes or precipitating factors, intensive self-management education may reduce seizure frequency, improve quality of life, increase adherence with antiepileptic medication and reduce accidental injuries caused by seizures.",2020,"Quality of life had improved significantly in the IEG (p < 0.001), but not in the REG (p = 0.073).","['Adult patients with epilepsy (PWE) able to identify prodromes or precipitating factors of their seizures', 'patients with epileptic seizures with prodromes or precipitating factors', 'epilepsy patients with prodromes or precipitating factors']","['intensive self-management education strategy', 'intensive education group (IEG) (n = 45) or a regular education group(REG', 'intensive self-management education']","['seizure frequency in the IEG', 'seizure frequency and quality of life', 'Drug adherence', 'quality of life', 'accidental injuries', 'seizure frequency, quality of life(Quality of life in epilepsy-31 inventory scores, QOLIE 31), and drug adherence(Morisky medication adherence scale,MMAS', 'Quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0240805', 'cui_str': 'Prodrome'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C4317109', 'cui_str': 'Epileptic Seizures'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0151736', 'cui_str': 'Accidental injury (disorder)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0222045'}]",47.0,0.0654244,"Quality of life had improved significantly in the IEG (p < 0.001), but not in the REG (p = 0.073).","[{'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China.""}, {'ForeName': 'Chenqi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China.""}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China.""}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China. Electronic address: shb1369@aliyun.com.""}]",Seizure,['10.1016/j.seizure.2020.03.003']
213,32330694,Loading modality and age influence teriparatide-induced bone formation in the human femoral neck.,"Teriparatide (TPTD) reduces risk of both vertebral and nonvertebral fracture, but increases bone mineral density (BMD) much more at the spine than the hip. TPTD and mechanical loading may have a synergistic anabolic effect on BMD, which may help explain these site-specific differences. Under normal daily activity, the femoral neck (FN) is under bending, placing one side under tension and the other under compression. We sought to further understand the relationship between mechanical loading and TPTD at the hip by investigating the effect of tensile versus compressive loading on TPTD stimulated bone formation indices in the human FN. Thirty-eight patients receiving total hip replacements for osteoarthritis were randomized to receive placebo (PBO) or TPTD for a mean treatment duration of 6 weeks prior to surgery, and double tetracycline labeling was administered to allow assessment of bone formation. The FN was harvested during surgery and analyzed for dynamic bone formation indices in the compressive and tensile regions of the endocortical and periosteal envelopes. Regression models relating outcome measures to patient characteristics including sex, age, body weight, and FN geometry were also analyzed. Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface. The level of bone formation in both TPTD and placebo groups was greater on the tensile endocortical surface and the compressive periosteal surface. There was a trend toward decreased endocortical eroded surface with TPTD in the compressive but not the tensile region. Patient age and sex explained the greatest variability in endocortical bone formation, and patient body mass and sex explained the greatest variability in periosteal bone formation. Our data represent the first dynamic comparison of teriparatide treatment under two loading modalities in human FN samples. Future work could determine whether specific hip loading intervention could amplify the benefits of teriparatide on the hip in clinical settings.",2020,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","['Thirty-eight patients receiving total hip replacements for osteoarthritis', 'human femoral neck', 'human FN']","['teriparatide', 'TPTD versus placebo', 'placebo', 'tetracycline labeling', 'teriparatide-induced bone formation', 'Teriparatide (TPTD', 'placebo (PBO) or TPTD']","['level of bone formation', 'bone mineral density (BMD', 'tensile endocortical surface', 'bone formation', 'patient characteristics including sex, age, body weight, and FN geometry']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}]",38.0,0.027878,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Rooney', 'Affiliation': 'Nancy E. and Peter C. Meinig School of Biomedical Engineering, Cornell University, 101 Weill Hall, Ithaca, NY 14853, USA. Electronic address: amr427@cornell.edu.'}, {'ForeName': 'Mathias P G', 'Initials': 'MPG', 'LastName': 'Bostrom', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA. Electronic address: BostromM@hss.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dempster', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Pathology, Columbia University, 630 West 168th St., New York, NY 10025, USA.'}, {'ForeName': 'Jeri W', 'Initials': 'JW', 'LastName': 'Nieves', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA; Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Epidemiology, Columbia University, 722 West 168th St., New York, NY 10032, USA. Electronic address: jwn5@cumc.columbia.edu.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA. Electronic address: zhouh@helenhayeshosp.org.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, 622 West 168th St., New York, NY 10032, USA. Electronic address: fc14@cumc.columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115373']
214,31939839,Anesthetic Management Using Multiple Closed-loop Systems and Delayed Neurocognitive Recovery: A Randomized Controlled Trial.,"BACKGROUND
Cognitive changes after anesthesia and surgery represent a significant public health concern. We tested the hypothesis that, in patients 60 yr or older scheduled for noncardiac surgery, automated management of anesthetic depth, cardiac blood flow, and protective lung ventilation using three independent controllers would outperform manual control of these variables. Additionally, as a result of the improved management, patients in the automated group would experience less postoperative neurocognitive impairment compared to patients having standard, manually adjusted anesthesia.
METHODS
In this single-center, patient-and-evaluator-blinded, two-arm, parallel, randomized controlled, superiority study, 90 patients having noncardiac surgery under general anesthesia were randomly assigned to one of two groups. In the control group, anesthesia management was performed manually while in the closed-loop group, the titration of anesthesia, analgesia, fluids, and ventilation was performed by three independent controllers. The primary outcome was a change in a cognition score (the 30-item Montreal Cognitive Assessment) from preoperative values to those measures 1 week postsurgery. Secondary outcomes included a battery of neurocognitive tests completed at both 1 week and 3 months postsurgery as well as 30-day postsurgical outcomes.
RESULTS
Forty-three controls and 44 closed-loop patients were assessed for the primary outcome. There was a difference in the cognition score compared to baseline in the control group versus the closed-loop group 1 week postsurgery (-1 [-2 to 0] vs. 0 [-1 to 1]; difference 1 [95% CI, 0 to 3], P = 0.033). Patients in the closed-loop group spent less time during surgery with a Bispectral Index less than 40, had less end-tidal hypocapnia, and had a lower fluid balance compared to the control group.
CONCLUSIONS
Automated anesthetic management using the combination of three controllers outperforms manual control and may have an impact on delayed neurocognitive recovery. However, given the study design, it is not possible to determine the relative contribution of each controller on the cognition score.",2020,There was a difference in the cognition score compared to baseline in the control group versus the closed-loop group 1 week postsurgery (-1 [-2 to 0] vs. 0,"['90 patients having noncardiac surgery under general anesthesia', 'patients 60 yr or older scheduled for noncardiac surgery, automated management of anesthetic depth, cardiac blood flow, and protective lung ventilation using three independent controllers would outperform manual control of these variables']",['Anesthetic Management Using Multiple Closed-loop Systems'],"['battery of neurocognitive tests', 'change in a cognition score (the 30-item Montreal Cognitive Assessment', 'postoperative neurocognitive impairment', 'cognition score', '30-day postsurgical outcomes', 'fluid balance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0554804', 'cui_str': 'Ventilation assistance'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3496286'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}]",90.0,0.136412,There was a difference in the cognition score compared to baseline in the control group versus the closed-loop group 1 week postsurgery (-1 [-2 to 0] vs. 0,"[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Joosten', 'Affiliation': 'From the Department of Anesthesiology (A.J., A.B., V.J., L.V.O, L.B.) Department of Clinical and Cognitive Neuropsychology (H.S.) Erasme Hospital, and Department of Anesthesiology, Brugmann Hospital (P.V.d.L.), Université Libre de Bruxelles, Brussels, Belgium Department of Anesthesiology and Intensive Care, University of Paris-Saclay, Bicetre Hospital, Le Kremlin-Bicêtre, Paris, France (A.J.) Department of Anesthesiology and Perioperative Care, University of California, Irvine, Irvine, California (J.R.) Department of Anesthesiology, University of California, San Diego, San Diego, California (B.A.) Department of Anesthesiology and Perioperative Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California (M.C., S.V.) Department of Anesthesiology, Foch Hospital, Suresnes, Paris, France (N.L.) Outcome Research Consortium, Cleveland Clinic, Cleveland, Ohio (N.L.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rinehart', 'Affiliation': ''}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Bardaji', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van der Linden', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Jame', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Obbergh', 'Affiliation': ''}, {'ForeName': 'Brenton', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': ''}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Cannesson', 'Affiliation': ''}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Vacas', 'Affiliation': ''}, {'ForeName': 'Ngai', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Hichem', 'Initials': 'H', 'LastName': 'Slama', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Barvais', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003014']
215,31939849,Postoperative Pain and Analgesic Requirements in the First Year after Intraoperative Methadone for Complex Spine and Cardiac Surgery.,"BACKGROUND
Methadone is a long-acting opioid that has been reported to reduce postoperative pain scores and analgesic requirements and may attenuate development of chronic postsurgical pain. The aim of this secondary analysis of two previous trials was to follow up with patients who had received a single intraoperative dose of either methadone or traditional opioids for complex spine or cardiac surgical procedures.
METHODS
Preplanned analyses of long-term outcomes were conducted for spinal surgery patients randomized to receive 0.2 mg/kg methadone at the start of surgery or 2 mg hydromorphone at surgical closure, and for cardiac surgery patients randomized to receive 0.3 mg/kg methadone or 12 μg/kg fentanyl intraoperatively. A pain questionnaire assessing the weekly frequency (the primary outcome) and intensity of pain was mailed to subjects 1, 3, 6, and 12 months after surgery. Ordinal data were compared with the Mann-Whitney U test, and nominal data were compared using the chi-square test or Fisher exact probability test. The criterion for rejection of the null hypothesis was P < 0.01.
RESULTS
Three months after surgery, patients randomized to receive methadone for spine procedures reported the weekly frequency of chronic pain was less (median score 0 on a 0 to 4 scale [less than once a week] vs. 3 [daily] in the hydromorphone group, P = 0.004). Patients randomized to receive methadone for cardiac surgery reported the frequency of postsurgical pain was less at 1 month (median score 0) than it was in patients randomized to receive fentanyl (median score 2 [twice per week], P = 0.004).
CONCLUSIONS
Analgesic benefits of a single dose of intraoperative methadone were observed during the first 3 months after spinal surgery (but not at 6 and 12 months), and during the first month after cardiac surgery, when the intensity and frequency of pain were the greatest.",2020,"Patients randomized to receive methadone for cardiac surgery reported the frequency of postsurgical pain was less at 1 month (median score 0) than it was in patients randomized to receive fentanyl (median score 2 [twice per week], P = 0.004).
","['patients who had received a single intraoperative dose of either', 'for complex spine or cardiac surgical procedures']","['hydromorphone', 'fentanyl', 'methadone or 12 μg/kg fentanyl intraoperatively', 'methadone or traditional opioids', 'methadone', 'Methadone']","['intensity of pain', 'weekly frequency of chronic pain', 'frequency of postsurgical pain', 'Postoperative Pain and Analgesic Requirements', 'intensity and frequency of pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0018821', 'cui_str': 'Surgical Procedures, Heart'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.218647,"Patients randomized to receive methadone for cardiac surgery reported the frequency of postsurgical pain was less at 1 month (median score 0) than it was in patients randomized to receive fentanyl (median score 2 [twice per week], P = 0.004).
","[{'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Murphy', 'Affiliation': 'From the Department of Anesthesiology, NorthShore University HealthSystem, University of Chicago Pritzker School of Medicine, Evanston, Illinois (G.S.M., S.B.G., T.D.S., M.A.D., D.D., S.B., J.B., C.E.M., G.J.T., K.J.T., J.W.S.) the Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (M.J.A.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Avram', 'Affiliation': ''}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Greenberg', 'Affiliation': ''}, {'ForeName': 'Torin D', 'Initials': 'TD', 'LastName': 'Shear', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Deshur', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dickerson', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bilimoria', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Benson', 'Affiliation': ''}, {'ForeName': 'Colleen E', 'Initials': 'CE', 'LastName': 'Maher', 'Affiliation': ''}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Trenk', 'Affiliation': ''}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Teister', 'Affiliation': ''}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Szokol', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003025']
216,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND
To assess the efficacy of combined 5FU and Avastin injections in the treatment of primary pterygium METHODS: Sixteen eyes with primary pterygium received intralesional 5 fluorouracil and Avastin (2.5-5 mg) injections every 2 weeks for a maximum of five injections. Fourteen eyes of 14 patients received five injections, one eye received three injections and one eye received two injections. All eyes were followed at monthly intervals for 3 months after last injection. Tissue was obtained by surgical excision of primary pterygium from four eyes who received injections and three eyes with primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I.
RESULTS
Pterygium progression was arrested in all patients. Sixty-two percent of patients had improvement of redness while 89% had reduced thickness of the lesion. VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
CONCLUSIONS
The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0']
217,32334146,Impact of viewing body image health promotion videos in adult men and women: Comparison of narrative and informational approaches.,"Body dissatisfaction is a serious public health issue, however, low awareness of its seriousness, and stigma, may inhibit treatment seeking. Social marketing videos using narrative-entertainment or documentary-informational style approaches may enhance awareness but little research has evaluated their impact, particularly potentially harmful effects. The current study addressed this gap. Men (n = 226) and women (n = 229), were randomly allocated to view one of four videos; (1) Narrative, (2) Narrative plus persuasive appeal, (3) Informational, and (4) Informational plus persuasive appeal. Outcome variables were assessed before and after viewing. A time-by-video interaction indicated an increase in perception of the importance of body dissatisfaction as a public health problem following informational, but not narrative videos. Time by gender interactions showed that women, but not men, experienced increased body weight satisfaction and reduced intentions to engage in body-talk after video viewing. Time main effects revealed improvements in perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison. Findings suggest that social marketing can increase awareness of body dissatisfaction without inadvertently causing harm. Results from this study provide preliminary support for dissemination through social marketing.",2020,"Time main effects revealed improvements in perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison.","['adult men and women', 'Men (n\u202f=\u202f226) and women (n\u202f=\u202f229']","['Narrative plus persuasive appeal, (3) Informational, and (4) Informational plus persuasive appeal', 'social marketing', 'viewing body image health promotion videos']","['body weight satisfaction and reduced intentions to engage in body-talk', 'perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison', 'awareness of body dissatisfaction', 'perception of the importance of body dissatisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0312284,"Time main effects revealed improvements in perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison.","[{'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'McLean', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Australia; Institute for Health and Sport, Victoria University, Melbourne, Australia. Electronic address: s.mclean@latrobe.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.04.001']
218,32335287,Isradipine enhancement of virtual reality cue exposure for smoking cessation: Rationale and study protocol for a double-blind randomized controlled trial.,"Cigarette smoking remains a leading cause of preventable death in the United States, contributing to over 480,000 deaths each year. Although significant strides have been made in the development of effective smoking cessation treatments, most established interventions are associated with high relapse rates. One avenue for increasing the effectiveness of smoking cessation interventions is to design focused, efficient, and rigorous experiments testing engagement of well-defined mechanistic targets. Toward this aim, the current protocol will apply a pharmacologic augmentation strategy informed by basic research in animal models of addiction. Our goal is to evaluate the enhancing effect of isradipine, an FDA-approved calcium channel blocker, on the extinction of craving-a key mechanism of drug relapse after periods of abstinence. To activate craving robustly in human participants, we will use multimodal smoking cues including novel 360° video environments developed for this project and delivered through consumer virtual reality headsets. Adult smokers will take either isradipine or placebo and complete the cue exposure protocol in a double-blind randomized control trial. In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo. The study will be implemented in a primary care setting where adult smokers receive healthcare, and smoking behavior will be tracked throughout the trial with ecological momentary assessment.",2020,"In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo.","['human participants', 'Adult smokers', 'smoking cessation']","['isradipine', 'Isradipine', 'isradipine or placebo']",[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.135599,"In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA. Electronic address: spapini@utexas.edu.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Young', 'Affiliation': 'School of Nursing, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Gebhardt', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Perrone', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Morikawa', 'Affiliation': 'Department of Neuroscience, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106013']
219,32302930,"Attentional prioritization in dual-task walking: Effects of stroke, environment, and instructed focus.","BACKGROUND
The impact of high distraction, real-world environments on dual-task interference and flexibility of attentional prioritization during dual-task walking in people with stroke is unknown.
RESEARCH QUESTION
How does a real-world environment affect dual-task performance and flexible task prioritization during dual-task walking in adults with and without stroke?
METHODS
Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated. Single and dual-task walking were examined in two different environments (lab hallway, hospital lobby). Two different dual-task combinations were assessed (Stroop-gait, speech-gait). Each dual-task was performed first without explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction in randomized order.
RESULTS
People with stroke had significantly slower dual-task gait speed (Stroop only) in the lobby than the lab, but the effect was not clinically meaningful. Stroop reaction time for all participants was also slower in the lobby than the lab. All participants slowed their walking speed while generating spontaneous speech, but this effect was not influenced by environment. The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
SIGNIFICANCE
Although dual-tasking slows walking speed and verbal responses to auditory stimuli in people with stroke, the effects are not considerably impacted by a more complex, distracting environment. Adults with and without stroke may have difficulty overriding the preferred attention allocation strategy during dual-task walking, especially for habitual dual-tasks such as walking while speaking. It may also be that the cognitive control strategy governing task prioritization is influenced by degree of cognitive engagement.",2020,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","['Adults with and without stroke', 'adults with and without stroke', 'Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated', 'people with stroke']",['explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction'],"['walking speed while generating spontaneous speech', 'Stroop reaction time', 'dual-task gait speed']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",23.0,0.0469792,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","[{'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Plummer', 'Affiliation': 'Department of Physical Therapy, MGH Institute of Health Professions, 36 1st Avenue, Boston, MA, 02129, United States. Electronic address: pplummer@mghihp.edu.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Altmann', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Feld', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, NC, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zukowski', 'Affiliation': 'Department of Physical Therapy, High Point University, High Point, NC, United States.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Najafi', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Giuliani', 'Affiliation': 'Department of Allied Health Sciences, University of North Carolina at Chapel Hill, NC, United States.'}]",Gait & posture,['10.1016/j.gaitpost.2020.03.013']
220,32305825,Effect of pregnancy and exclusive breastfeeding on multiple sclerosis relapse rate and degree of disability within two years after delivery.,"OBJECTIVES
Pregnancy and lactation are important issues for women with multiple sclerosis (MS). The purpose of this study was to investigate the effect of pregnancy and exclusive breastfeeding on the rate of relapse and degree of disability within two years after delivery among patients with relapsing remitting multiple sclerosis (RRMS).
PATIENTS AND METHODS
30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017. Each patient was examined every three months for 33 months. In the study group, patients were examined at the beginning of pregnancy, and then every three months till 24th months after delivery.
RESULTS
In the study group, Expanded Disability Status Scale (EDSS) during the third trimester of pregnancy, between four to nine month after delivery, and the last 6 months of the study were significantly lower than the control group (p < 0.05). At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05). Also, EDSS during the second and third trimesters of pregnancy were significantly lower than the EDSS before pregnancy (p < 0.05). The mean number of relapses in the second and third trimesters of pregnancy, between four to six months after delivery, and the total number of relapses were significantly lower than the control group.
CONCLUSION
Pregnancy and exclusive breastfeeding can have a positive effect in reducing relapse rate and disability. This effect will continue until the 24th month after childbirth.",2020,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","['patients with relapsing remitting multiple sclerosis (RRMS', '30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017', 'women with multiple sclerosis (MS']",['pregnancy and exclusive breastfeeding'],"['total number of relapses', 'Expanded Disability Status Scale (EDSS', 'relapse rate and disability', 'mean EDSS', 'multiple sclerosis relapse rate and degree of disability', 'rate of relapse and degree of disability', 'mean number of relapses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0139494,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ghiasian', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Nouri', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Abdorreza Naser', 'Initials': 'AN', 'LastName': 'Moghadasi', 'Affiliation': 'Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Ghaffari', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: m.ghaffari@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105829']
221,32325415,Whole-body vibration and stretching enhances dorsiflexion range of motion in individuals with chronic ankle instability.,"OBJECTIVE
The purpose of this study was to determine if WBV performed concurrently with static stretching was more effective than static stretching alone to increase dorsiflexion ROM (DFROM) in individuals with chronic ankle instability (CAI).
DESIGN
Controlled laboratory study.
PARTICIPANTS
Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score) were divided into 3 groups (normative (N), static stretch (SS), and static stretch with vibration (SV)). Participants stretched the triceps surae 4 days/wk for 3 wks. Vibration was imposed at 34 Hz and 1.8 mm.
MAIN OUTCOME MEASURES
DFROM was assessed in a straight and bent-leg position.
RESULTS
No differences were detected at any time in the N or SS group, however SS did exhibit large effect sizes with 95% confidence intervals (CI) that did not cross zero from baseline to 3 weeks for both measures. The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
CONCLUSIONS
Static stretching with WBV increases DFROM in participants with CAI more effectively than static stretching alone.",2020,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","['participants with CAI', 'individuals with chronic ankle instability', 'Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score', 'individuals with chronic ankle instability (CAI']","['static stretch (SS), and static stretch with vibration (SV', 'static stretching', 'static stretching alone']","['DFROM', 'dorsiflexion ROM (DFROM', 'DFROM was assessed in a straight and bent-leg position']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",39.0,0.0500288,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","[{'ForeName': 'Feland', 'Initials': 'F', 'LastName': 'Jb', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: brent_feland@byu.edu.'}, {'ForeName': 'Thalman', 'Initials': 'T', 'LastName': 'Lesley', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: lesleyabigail@gmail.com.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'I', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: iain_hunter@byu.edu.'}, {'ForeName': 'Cochrane', 'Initials': 'C', 'LastName': 'Dj', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand. Electronic address: D.Cochrane@massey.ac.nz.'}, {'ForeName': 'Hopkins', 'Initials': 'H', 'LastName': 'Jt', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: tyhopkins@byu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.001']
222,32328440,Internet-based self-help intervention aimed at increasing social self-efficacy among internal migrants in Poland: Study protocol for a randomized controlled trial.,"Background
Migration is a challenging life transition that may be a source of various problems related to well-being and mental health. However, the psychological adaptation of migrants may be potentially facilitated by social self-efficacy-the beliefs in one's ability to initiate and maintain interpersonal relationships. Previous research suggests that social self-efficacy is positively related to adjustment and negatively related to loneliness, depression, and psychological distress. Research also confirms that self-efficacy beliefs can be effectively enhanced using Internet-based interventions. These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to sources of self-efficacy beliefs: mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states. Users complete increasingly challenging tasks that encourage them to interact with their environment. The aim of this trial was to investigate the efficacy of the New in Town intervention.
Methods
The efficacy of the New in Town intervention will be tested in a two-arm randomized controlled trial with a waitlist control group. Social self-efficacy will be the primary outcome. Secondary outcomes will include loneliness, perceived social support, and satisfaction with life. Additionally, we will measure user experience among participants allocated to the experimental group. We aim to recruit a total of N = 280 participants aged at least 18 years who have changed their place of residence in the last 6 months and have an Internet connection. Participants will be assessed at baseline, 3-week post-test, and 8-week follow-up.
Discussion
The trial will provide insights into the efficacy of Internet-based self-help interventions in increasing social self-efficacy. Given that the intervention works, New in Town could provide an easily accessible support option for internal migrants in Poland.
Trial registration
The trial was registered with ClinicalTrials.gov (identifier: NCT04088487) on 11th September 2019.",2020,"These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy.",['total of N \u202f=\u202f280 participants aged at least 18\u202fyears who have changed their place of residence in the last 6\u202fmonths and have an Internet connection'],"['Internet-based self-help intervention', 'Internet-based self-help interventions']","['Social self-efficacy', 'loneliness, perceived social support, and satisfaction with life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449379', 'cui_str': 'Connection'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",280.0,0.0703208,"These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rogala', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Szczepaniak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Internet interventions,['10.1016/j.invent.2020.100322']
223,32330775,Treatment with intravenous immunoglobulin increases the level of small EVs in plasma of pregnant women with recurrent pregnancy loss.,"Extracellular vesicles (EVs), which are small cell-derived compartments, take part in numerous different physiological processes. The contents of EVs reveal the cell of origin and indicates pathophysiological states in different diseases. In pregnancy disorders, changes have been reported in the composition, bioactivity and concentration of placental and non-placental EVs. The purpose of this study was to monitor the effects on EVs in patients receiving intravenous immunoglobulin (IVIG) or placebo (albumin) treatment due to recurrent pregnancy loss (RPL). In a placebo-controlled trial study of IVIG treatment, plasma collected from 39 women with RPL were investigated using the Extracellular Vesicle Array (EV Array). Plasma was sampled consecutively (from gestational week (GW) 5) and the protein phenotypes of the smaller EVs (sEVs) were analyzed for the presence of 34 markers. The levels of sEVs or changes in their levels in early pregnancy were correlated with treatment. There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo. In conclusion, the treatment with high-doses of IVIG clearly boosted the production and release of sEVs to the circulation; however, the biological role of this boost remains to be clarified in further studies.",2020,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"['pregnant women with recurrent pregnancy loss', '39 women with RPL', 'patients receiving']","['placebo', 'intravenous immunoglobulin', 'intravenous immunoglobulin (IVIG) or placebo (albumin']","['levels of sEVs or changes in their levels in early pregnancy', 'level of small EVs', 'levels of sEVs']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0560135', 'cui_str': 'eV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}]",39.0,0.0521941,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"[{'ForeName': 'Malene Møller', 'Initials': 'MM', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark. Electronic address: maljoe@rn.dk.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Bæk', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Sloth', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Varming', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Ole Bjarne', 'Initials': 'OB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Nadja Emilie', 'Initials': 'NE', 'LastName': 'Ditlevsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rajaratnam', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103128']
224,32199197,Evolving role of regorafenib for the treatment of advanced cancers.,"Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib. Regorafenib was initially approved for mCRC based on improved overall survival (OS) in the randomized, placebo-controlled, phase 3 CORRECT trial, which was confirmed in an expanded population of Asian patients in the randomized, placebo-controlled phase 3 CONCUR trial. Approvals in GIST, and more recently in HCC, were based on the results from the randomized, placebo-controlled, phase 3 GRID and RESORCE trials, respectively. In this review, we provide a comprehensive summary of the clinical evidence for approval of regorafenib in mCRC, GIST, and HCC, present emerging evidence of regorafenib activity in other tumor types (namely, gastroesophageal cancer, sarcomas, biliary tract cancer, and glioblastoma), and discuss trials in progress within the context of regorafenib's mechanism of action. We describe recent advances and key lessons learned with regorafenib, including the importance of managing common drug-related toxicities using dose-optimization strategies, the search for biomarkers to predict response to treatment, and highlight some of the unaddressed questions and future directions for regorafenib across tumors.",2020,"Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib.","['advanced cancers', 'refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on']","['regorafenib', 'placebo', 'sorafenib', 'Regorafenib', 'oral tyrosine kinase inhibitor (TKI']",['overall survival (OS'],"[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.175471,"Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': 'West Cancer Center, Germantown, TN, USA. Electronic address: agrothey@westclinic.com.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Léon Bérard Centre and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Royal North Shore Hospital, St Leonards, Australia.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Bruix', 'Affiliation': 'BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Barcelona, Spain.'}]",Cancer treatment reviews,['10.1016/j.ctrv.2020.101993']
225,32199333,Effect of pre-term birth on oxidative stress responses to normoxic and hypoxic exercise.,"Pre-term birth is a major health concern that occurs in approximately 10% of births worldwide. Despite high incidence rate, long-term consequences of pre-term birth remain unclear. Recent evidence suggests that elevated oxidative stress observed in pre-term born infants could persist into adulthood. Given that oxidative stress is known to play an important role in response to physical activity and hypoxia, we investigated whether oxidative stress responses to acute exercise in normoxia and hypoxia may be differently modulated in pre-term vs. full-term born adults. Twenty-two pre-term born and fifteen age-matched full-term born controls performed maximal incremental cycling tests in both normoxia (FiO2: 0.21) and normobaric hypoxia (FiO2: 0.13; simulated altitude of 3800 m) in blinded and randomized manner. Plasma levels of oxidative stress (advanced oxidation protein products [AOPP] and malondialdehyde), antioxidant (ferric reducing antioxidant power, glutathione peroxidase, catalase [CAT] and superoxide dismutase [SOD]) and nitrosative stress markers (nitrotyrosine, nitrite and total nitrite and nitrate [NOx]) were measured before and immediately after each test. AOPP (+24%, P<0.001), CAT (+38%, P<0.001) and SOD (+12%, P=0.018) and NOx (+17%, P=0.024) significantly increased in response to exercise independently of condition and birth status. No difference in response to acute exercise in normoxia was noted between pre-term and full-term born adults in any of measured markers. Hypoxic exposure during exercise resulted in significant increase in AOPP (+45%, P=0.008), CAT (+55%, P=0.019) and a trend for an increase in nitrite/nitrate content (+35%, P=0.107) only in full-term and not pre-term born individuals. These results suggest that prematurely born adult individuals exhibit higher resistance to oxidative stress response to exercise in hypoxia.",2020,"Hypoxic exposure during exercise resulted in significant increase in AOPP (+45%, P=0.008), CAT (+55%, P=0.019) and a trend for an increase in nitrite/nitrate content (+35%, P=0.107) only in full-term and not pre-term born individuals.",['Twenty-two pre-term born and fifteen age-matched full-term born controls performed'],"['maximal incremental cycling tests in both normoxia (FiO2: 0.21) and normobaric hypoxia (FiO2', 'normoxic and hypoxic exercise']","['ferric reducing antioxidant power, glutathione peroxidase, catalase [CAT] and superoxide dismutase [SOD]) and nitrosative stress markers (nitrotyrosine, nitrite and total nitrite and nitrate [NOx', 'elevated oxidative stress', 'Plasma levels of oxidative stress (advanced oxidation protein products [AOPP] and malondialdehyde), antioxidant ', 'NOx ', 'response to acute exercise in normoxia', 'CAT', 'nitrite/nitrate content', 'SOD', 'AOPP']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C4517437', 'cui_str': '0.21 (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C4505047', 'cui_str': 'Nitrosative Stress'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1976991', 'cui_str': 'AOPPs'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",,0.074492,"Hypoxic exposure during exercise resulted in significant increase in AOPP (+45%, P=0.008), CAT (+55%, P=0.019) and a trend for an increase in nitrite/nitrate content (+35%, P=0.107) only in full-term and not pre-term born individuals.","[{'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': ""Univ Lyon, Université Claude Bernard Lyon 1, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine Rockefeller, 69008 Lyon, France; Univ Lyon, Université Jean Monet Saint-Etienne, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine, Campus Santé Innovation, 10 rue de la Marandière10 rue de la Marandière, Saint-Priest-en-Jarez, France; Univ Lyon, Université Claude Bernard Lyon 1, Master BioSciences, Department of Biology, École Normale Supérieure of Lyon, 46 allée d'Italie, 69364 LYON CEDEX 07, Lyon, France. Electronic address: agnes.martin@ens-lyon.org.""}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Millet', 'Affiliation': 'ISSUL, Institute of Sport Sciences, Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland. Electronic address: gregoire.millet@unil.ch.'}, {'ForeName': 'Damjan', 'Initials': 'D', 'LastName': 'Osredkar', 'Affiliation': ""Department of Pediatric Neurology, University Children's Hospital Ljubljana, Ljubljana, Slovenia. Electronic address: damjan.osredkar@kclj.si.""}, {'ForeName': 'Minca', 'Initials': 'M', 'LastName': 'Mramor', 'Affiliation': 'Faculty of Sport, University of Ljubljana, Ljubljana, Slovenia. Electronic address: minca.mramor@ukclj.si.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Faes', 'Affiliation': 'Univ Lyon, Université Claude Bernard Lyon 1, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine Rockefeller, 69008 Lyon, France; Laboratory of Excellence GR-Ex, Paris, France. Electronic address: camille.faes@univ-lyon1.fr.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Gouraud', 'Affiliation': 'Univ Lyon, Université Claude Bernard Lyon 1, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine Rockefeller, 69008 Lyon, France; Laboratory of Excellence GR-Ex, Paris, France. Electronic address: etienne.gouraud@univ-lyon1.fr.'}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Debevec', 'Affiliation': ""Faculty of Sport, University of Ljubljana, Ljubljana, Slovenia; Department of Pediatric Emergency, University Children's Hospital Ljubljana, Ljubljana, Slovenia; Department of Automation, Biocybernetics and Robotics, Jozef Stefan Institute, Ljubljana, Slovenia. Electronic address: tadej.debevec@fsp.uni-lj.si.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pialoux', 'Affiliation': 'Univ Lyon, Université Claude Bernard Lyon 1, Laboratoire Interuniversitaire de Biologie de la Motricité EA 7424, Faculté de Médecine Rockefeller, 69008 Lyon, France; Laboratory of Excellence GR-Ex, Paris, France; Institut Universitaire de France, France. Electronic address: vincent.pialoux@univ-lyon1.fr.'}]",Redox biology,['10.1016/j.redox.2020.101497']
226,32220760,Performance of PI-RADS v2 assessment categories assigned prior to MR-US fusion biopsy in a new fusion biopsy program.,"OBJECTIVE
To validate the performance of PI-RADS v2 for detection of clinically significant prostate cancer (csPca, Gleason ≥7) within the context of a new fusion biopsy program.
MATERIAL AND METHODS
Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified. Diagnostic performance of PI-RADS v2 was calculated using fusion biopsy results as reference standard using receiver operating characteristic curve analysis. Patient and lesion characteristics were analyzed with one-way ANOVA and Wilcoxon rank sum test.
RESULTS
Of 83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7. csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001). For prediction of csPCa, patient-level AUC was 0.68 and lesion-level AUC was 0.77. Biopsy threshold of PI-RADS ≥3 was 92.6% sensitive and 22.1% specific. A threshold of PI-RADS ≥4 was 87.2% sensitive and 58.1% specific. Rate of csPca detection on concurrent standard 12 core biopsy only was 6.7%.
CONCLUSION
PI-RADS v2 assessment categories assigned prior to biopsy predict pathologic outcome reasonably well in a new prostate fusion biopsy program. Biopsy threshold of PI-RADS ≥3 is highly sensitive. A threshold of ≥4 increases specificity but misses some csPCa.",2020,"csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001).","['Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified', '83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7']",['MR-US fusion biopsy'],"['csPCa rates', 'Diagnostic performance of PI-RADS', 'Rate of csPca detection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}]",83.0,0.0252138,"csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001).","[{'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Trent', 'Affiliation': 'University of Maryland School of Medicine, 655 W Baltimore Street, Baltimore, MD 21201, United States of America. Electronic address: Graham.Trent@somalumni.umaryland.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ye', 'Affiliation': 'University of Maryland School of Medicine, 655 W Baltimore Street, Baltimore, MD 21201, United States of America. Electronic address: Nancy.y.ye@kp.org.'}, {'ForeName': 'Jasleen', 'Initials': 'J', 'LastName': 'Chopra', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 100 North Greene Street, Suite 411, Baltimore, MD 21201, United States of America. Electronic address: rchen@umm.edu.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Wong-You-Cheong', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America. Electronic address: jwong@umm.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Naslund', 'Affiliation': 'University of Maryland School of Medicine, Department of Urology, 419 W. Redwood Street, Suite 320, Baltimore, MD 21201, United States of America. Electronic address: mnaslund@som.umaryland.edu.'}, {'ForeName': 'Mohummad M', 'Initials': 'MM', 'LastName': 'Siddiqui', 'Affiliation': 'University of Maryland School of Medicine, Department of Urology, 419 W. Redwood Street, Suite 320, Baltimore, MD 21201, United States of America. Electronic address: msiddiqui@som.umaryland.edu.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Wnorowski', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America. Electronic address: AmeliaWnorowski@umm.edu.'}]",Clinical imaging,['10.1016/j.clinimag.2020.03.004']
227,32232698,Long-term (up to 16 months) health-related quality of life after adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy in women with high-risk early breast cancer.,"PURPOSE
To prospectively compare HRQoL effects of two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16 months after random assignment.
METHODS
The open-label, randomized, Phase 3 ""Panther trial"" was conducted between February 2007 and September 2011. 760 women, aged 65 years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer were randomized 1:1 to the experimental group (four cycles of tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2 weeks followed by four cycles of tailored dose-dense docetaxel/2 weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3 weeks followed by three cycles of docetaxel/3 weeks). HRQoL was assessed at all Swedish centres using EORTC QLQ-C30 and EORTC QLQ-BR23 at six points during 16 months before randomization.
RESULTS
Response rates to questionnaires were highest at baseline 728/780 (93%) and lowest 16 months after randomization, 557/750 (74%). HRQoL declined during treatment in both groups. At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects. No differences were found for emotional functioning, body image, and arm and breast symptoms. There were no statistically significant differences between the groups at the first follow-up and at subsequent assessments. HRQoL levels at the 16-month follow-up were similar to baseline values.
CONCLUSIONS
Negative HRQoL impact of the dose-dense and tailored strategy appears to be prominent during treatment, but HRQoL recover once treatment ends.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00798070; isrctn.org Identifier: ISRCTN39017665.",2020,"At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects.","['two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16\xa0months after random assignment', '760 women, aged 65\xa0years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer', 'women with high-risk early breast cancer']","['tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2\xa0weeks followed by four cycles of tailored dose-dense docetaxel/2\xa0weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3', 'adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy']","['HRQoL levels', 'emotional functioning, body image, and arm and breast symptoms', 'HRQoL', 'HRQoL effects', 'health-related quality of life', 'global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects']","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",760.0,0.0933665,"At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Brandberg', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. yvonne.brandberg@ki.se.'}, {'ForeName': 'Hemming', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Möbus', 'Affiliation': 'Department of Gynecology and Obstetrics, Goethe University Frankfurt/M, Frankfurt, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Medical Department, Medical University Hospital, Salzburg, Austria.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Foukakis', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-020-05602-9']
228,31168085,Mucosal lactoferrin response to genital tract infections is associated with iron and nutritional biomarkers in young Burkinabé women.,"BACKGROUND/OBJECTIVES
The iron-binding affinity of vaginal lactoferrin (Lf) reduces iron available to genital pathogens. We describe host reproductive, nutritional, infection and iron biomarker profiles affecting vaginal Lf concentration in young nulliparous and primigravid women in Burkina Faso.
SUBJECTS/METHODS
Vaginal eluates from women who had participated in a randomized, controlled periconceptional iron supplementation trial were used to measure Lf using a competitive double-sandwich ELISA. For this analysis samples from both trial arms were combined and pregnant and non-pregnant cohorts compared. Following randomization Lf was measured after 18 months (end assessment) for women remaining non-pregnant, and at two antenatal visits for those becoming pregnant. Associations between log Lf levels and demographic, anthropometric, infection and iron biomarker variables were assessed using linear mixed models.
RESULTS
Lf samples were available for 712 non-pregnant women at end assessment and for 303 women seen at an antenatal visit. Lf concentrations of pregnant women were comparable to those of non-pregnant, sexually active women. Lf concentration increased with mid-upper-arm circumference, (P = 0.047), body mass index (P = 0.018), Trichomonas vaginalis (P < 0.001) infection, bacterial vaginosis (P < 0.001), serum C-reactive protein (P = 0.048) and microbiota community state types III/IV. Adjusted Lf concentration was positively associated with serum hepcidin (P = 0.047), serum ferritin (P = 0.018) and total body iron stores (P = 0.042). There was evidence that some women maintained persistently high or low Lf concentrations from before, and through, pregnancy.
CONCLUSION
Lf concentrations increased with genital infection, higher BMI, MUAC, body iron stores and hepcidin, suggesting nutritional and iron status influence homeostatic mechanisms controlling vaginal Lf responses.",2019,"Lf concentration increased with mid-upper-arm circumference, (P = 0.047), body mass index (P = 0.018), Trichomonas vaginalis (P < 0.001) infection, bacterial vaginosis (P < 0.001), serum C-reactive protein (P = 0.048) and microbiota community state types III/IV.","['young nulliparous and primigravid women in Burkina Faso', '712 non-pregnant women at end assessment and for 303 women seen at an antenatal visit', 'pregnant women', 'young Burkinabé women', 'Vaginal eluates from women who had participated']",[],"['Lf concentration', 'Adjusted Lf concentration', 'log Lf levels and demographic, anthropometric, infection and iron biomarker variables', 'Mucosal lactoferrin response', 'Lf concentrations', 'Lf concentrations increased with genital infection, higher BMI, MUAC, body iron stores and hepcidin, suggesting nutritional and iron status influence homeostatic mechanisms controlling vaginal Lf responses', 'serum hepcidin', 'serum C-reactive protein', 'serum ferritin', 'body mass index', 'total body iron stores', 'Trichomonas vaginalis']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0301870', 'cui_str': 'Eluate'}]",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0729552', 'cui_str': 'Infectious disease of genitopelvic system'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1561987', 'cui_str': 'Homeostatic mechanism'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0040922', 'cui_str': 'Trichomonas vaginalis'}]",,0.0939264,"Lf concentration increased with mid-upper-arm circumference, (P = 0.047), body mass index (P = 0.018), Trichomonas vaginalis (P < 0.001) infection, bacterial vaginosis (P < 0.001), serum C-reactive protein (P = 0.048) and microbiota community state types III/IV.","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Roberts', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, Faculty of Biology, Medicine and Health, School of Medical Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Brabin', 'Affiliation': 'Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Diallo', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gies', 'Affiliation': 'Department of Biomedical Sciences, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium and Medical Mission Institute, Würzburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nelson', 'Affiliation': 'Faculty of Health and Life Sciences, University of Northumbria, Northumberland Building, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Swinkels', 'Affiliation': 'Department of Laboratory Medicine (TLM 830), Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Geurts-Moespot', 'Affiliation': 'Department of Laboratory Medicine (TLM 830), Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kazienga', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ouedraogo', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit (MRC), Fajara, The Gambia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Brabin', 'Affiliation': 'Liverpool School of Tropical Medicine, and Institute of Infection and Global Health, University of Liverpool, Liverpool, UK. b.j.brabin@liverpool.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0444-7']
229,31891694,Lung Volume Reduction Surgery: Reinterpreted With Longitudinal Data Analyses Methodology.,"BACKGROUND
The largest randomised controlled trial evaluating results of lung volume reduction surgery (LVRS) was conducted by the National Emphysema Treatment Trial (NETT) that published a series of reports for outcomes up to 24 months. However, patient outcomes were difficult to interpret due to limitations in and the presentation of conventional statistical analyses applied to longitudinal data. We reevaluated the NETT results using longitudinal data methodology to report longer-term outcomes to facilitate interpretation by clinicians and patients who are considering LVRS for emphysema management.
METHODS
Trial data were released by the United States National Institutes of Health and the National Heart, Lung, and Blood Institute and analyzed using a mixed-effects model. Data on the difference in lung function variables between patients receiving LVRS vs medical care out to 5 years were estimated and are presented.
RESULTS
The 5-year differences in patients randomised to LVRS were a small but sustained improvement in lung function indicators of forced expiratory volume in 1 second, forced vital capacity, and residual volume of +1.4% (P < .001), +3.44% (P < .001) and -19.49% (P < .001) of the predicted values, respectively. With regards to physiological function, the 5-year difference in patients randomised to LVRS was an overall 0.89 W improvement in maximum workload (P = .069), -4.12 improvement in shortness of breath score (P < .001), and 0.088 improvement in quality of well-being score (P = .102).
CONCLUSIONS
Our results suggest that LVRS continues to have an important role in the treatment of patients with severe emphysema, with long-term benefits to lung function variables and a sustained improvement to the relief of dyspnea.",2020,"The five-year differences in patients randomised to LVRS was a small but sustained improvement in lung function parameters of FEV1, FVC and RV of +1.4% (P<0.001), +3.44% ((P<0.001) and -19.49% (P<0.001) of the predicted values respectively.","['Trial data was released by the United States National Institute of Health and the United States National Heart, Lung and Blood Institute, and analysed using a mixed effects model', 'clinicians and patients who are considering LVRS for emphysema management']","['LVRS', 'lung volume reduction surgery (LVRS', 'Lung Volume Reduction Surgery']","['shortness of breath score', 'maximum workload', 'quality of well-being score', 'lung function parameters of FEV1, FVC and RV', 'lung function parameters']","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0005768'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}]","[{'cui': 'C0375931', 'cui_str': 'Lung volume reduction surgery'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0426106,"The five-year differences in patients randomised to LVRS was a small but sustained improvement in lung function parameters of FEV1, FVC and RV of +1.4% (P<0.001), +3.44% ((P<0.001) and -19.49% (P<0.001) of the predicted values respectively.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'Imperial College and the Academic Division of Thoracic Surgery, Royal Brompton Hospital, London, United Kingdom. Electronic address: e.lim@rbht.nhs.uk.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Sousa', 'Affiliation': 'Department of Health and Medicine, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': 'Imperial College and Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Diggle', 'Affiliation': 'Department of Health and Medicine, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Goldstraw', 'Affiliation': 'Imperial College and the Academic Division of Thoracic Surgery, Royal Brompton Hospital, London, United Kingdom.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.11.018']
230,32179059,Oxytocin increases the social salience of the outgroup in potential threat contexts.,"A growing body of literature suggests that OT administration may affect not only prosocial outcomes, but also regulate adversarial responses in the context of intergroup relations. However, recent reports have challenged the view of a fixed role of OT in enhancing ingroup favoritism and outgroup derogation. Studying the potential effects of OT in modulating threat perception in a context characterized by racial miscegenation (Brazil) may thus afford additional clarification on the matter. In a double-blind, placebo-controlled study, White Brazilian participants completed a first-person shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members. OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets). In summary, our results indicate that a single dose of OT may promote accurate behavioral responses to potential threat from members of a racial outgroup, thus offering support to the social salience hypothesis.",2020,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).",['White Brazilian participants completed a firstperson shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members'],"['OT', 'Oxytocin', 'placebo']",['social salience'],"[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3875150', 'cui_str': 'Towards'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.040038,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).","[{'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Egito', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nevat', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Simone G', 'Initials': 'SG', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Ana Alexandra C', 'Initials': 'AAC', 'LastName': 'Osório', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil. Electronic address: ana.osorio@mackenzie.br.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104733']
231,32304734,Cetirizine inhibits gender-specific blood cell dynamics upon allergen contact in allergic rhinitis.,"IgE-mediated inflammatory responses upon allergen contact in allergic rhinitis (AR) are associated with rapid alterations of circulating blood cell numbers detectable in a complete blood count (CBC). Aim of this study was to evaluate whether intake of antihistamines may modulate allergen-induced CBC dynamics in male and female patients. A total of N = 112 specific allergen challenges were performed in otherwise healthy AR subjects. Seventy-two (n = 72) subjects received placebo and forty (n = 40) received cetirizine (H1-receptor antagonist) per os prior to allergen exposure in a randomized, double-blind trial at the Vienna Challenge Chamber (VCC); a subgroup of twenty-five (n = 25) subjects received cetirizine and placebo on different study days (parallel group). Blood samples and symptom scores were taken at baseline and immediately after 6 h of airway challenge simulating ambient allergen contact. Female sex was associated with a pronounced circulating monocyte increase (p < .01) and male sex with an eosinophil decrease (p < .05) in the placebo group, but not in cetirizine treated subjects. The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes. A more prominent thrombocyte increase in female subjects (p < .05) was noted upon allergen exposure, regardless of prior cetirizine intake. Cetirizine inhibited the mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers, but did not affect thrombocyte increase upon allergen challenge. It further diminished gender-specific blood cell dynamics. Overall, as reflected in a simple CBC, cetirizine critically diminished immediate and late innate immune responses subsequent to allergen exposure.",2020,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"['allergic rhinitis', 'Seventy-two (n\u202f=\u202f72) subjects received', 'allergic rhinitis (AR', 'male and female patients', 'otherwise healthy AR subjects']","['cetirizine (H1-receptor antagonist) per os prior to allergen exposure', 'cetirizine and placebo', 'Cetirizine', 'antihistamines', 'placebo', 'cetirizine']","['circulating erythrocytes', 'segmented neutrophils', 'Blood samples and symptom scores', 'mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers', 'circulating monocyte increase']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0034814', 'cui_str': 'Histamine H1 receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0229640', 'cui_str': 'Segmented neutrophil'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0553698', 'cui_str': 'Monocyte count increased'}]",72.0,0.125116,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jordakieva', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria. Electronic address: galateja.jordakieva@meduniwien.ac.at.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Department of Environmental Health, Medical University of Vienna, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jensen-Jarolim', 'Affiliation': 'Institute of Pathophysiology and Allergy Research, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Austria; The Interuniversity Messerli Research Institute, Medical University Vienna, University of Veterinary Medicine Vienna, University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Crevenna', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2020.108422']
232,32227756,Management of Coronary Disease in Patients with Advanced Kidney Disease.,"BACKGROUND
Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease.
METHODS
We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
RESULTS
At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P = 0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
CONCLUSIONS
Among patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","['777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an', 'patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease', 'patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia', 'Patients with Advanced Kidney Disease']",['initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy'],"['risk of death or nonfatal myocardial infarction', '3-year event rate', 'composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'composite of death or nonfatal myocardial infarction', 'death or initiation of dialysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]",777.0,0.32092,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","[{'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Evgeny I', 'Initials': 'EI', 'LastName': 'Kretov', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Mazurek', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Roy O', 'Initials': 'RO', 'LastName': 'Mathew', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Pracon', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Herzog', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915925']
233,31148589,Dietary micronutrient intakes among women of reproductive age in Mumbai slums.,"OBJECTIVES
To (1) describe micronutrient intakes among women of reproductive age living in Mumbai slums; (2) assess the adequacy of these intakes compared with reference values; (3) identify important dietary sources of micronutrients.
SUBJECTS/METHODS
Participants were 6426 non-pregnant women aged 16-39 years, registered in a randomised controlled trial of a food-based intervention set in the Bandra, Khar and Andheri areas of Mumbai, India. Cross-sectional quantified food frequency questionnaire (FFQ) data were collected. Vitamin (n = 9) and mineral (n = 6) intakes were calculated and analysed in relation to dietary reference values (DRVs). Important dietary sources were identified for each micronutrient.
RESULTS
Median intakes of all micronutrients, except vitamin E, were below the FAO/WHO reference nutrient intake (RNI). Intakes of calcium, iron, vitamin A and folate were furthest from the RNI. For seven of the micronutrients, over half of the women had intakes below the lower reference nutrient intake (LRNI); this figure was over 75% for calcium and riboflavin. The majority of women (93%) had intakes below the EAR for 5 or more micronutrients, and 64% for 10 or more. Adolescents had lower intakes than women aged >19 years. Less than 1% of adult women and no adolescents met the EAR for all micronutrients. Animal source foods and micronutrient-rich fruit and vegetables were consumed infrequently.
CONCLUSIONS
These women had low intakes of multiple micronutrients, increasing their risk of insufficiency. There is a need to determine the factors causing poor intakes, to direct interventions that improve diet quality and nutritional sufficiency.",2019,"RESULTS
Median intakes of all micronutrients, except vitamin E, were below the FAO/WHO reference nutrient intake (RNI).","['women of reproductive age living in Mumbai slums', 'Adolescents had lower intakes than women aged >19 years', 'women of reproductive age in Mumbai slums', 'Participants were 6426 non-pregnant women aged 16-39 years']","['Vitamin', 'riboflavin']","['Intakes of calcium, iron, vitamin A and folate', 'Cross-sectional quantified food frequency questionnaire (FFQ) data']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0373720', 'cui_str': 'Vitamin B2'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",6426.0,0.0580757,"RESULTS
Median intakes of all micronutrients, except vitamin E, were below the FAO/WHO reference nutrient intake (RNI).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Nunn', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Kehoe', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK. sk@mrc.soton.ac.uk.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Chopra', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Sirazul A', 'Initials': 'SA', 'LastName': 'Sahariah', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Di Gravio', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Patsy J', 'Initials': 'PJ', 'LastName': 'Coakley', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Cox', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Harshad', 'Initials': 'H', 'LastName': 'Sane', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Shivshankaran', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Marley-Zagar', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Barrie M', 'Initials': 'BM', 'LastName': 'Margetts', 'Affiliation': 'Public Health Nutrition, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Jackson', 'Affiliation': 'National Institute for Health Research, Southampton Biomedical Research Centre, Southampton, UK.'}, {'ForeName': 'Ramesh D', 'Initials': 'RD', 'LastName': 'Potdar', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Caroline H D', 'Initials': 'CHD', 'LastName': 'Fall', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0429-6']
234,32086189,A cluster randomized controlled trial of the SoMe social media literacy body image and wellbeing program for adolescent boys and girls: Study protocol.,"Youth spend substantial time on social media, which can foster self-critical processes that increase risk of body dissatisfaction, disordered eating, and depressed mood. To date, there have been few investigations of interventions to decrease the negative impacts of social media engagement in adolescent boys and girls. This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles. The RCT will be conducted with grades 7-8 students from Australian secondary schools. Using block randomization, grade levels within schools will be assigned to either the SoMe program (intervention) or health lessons as usual (control). Primary outcomes will be body satisfaction, dietary restraint, and strategies to increase muscles. Secondary outcomes will be self-esteem and depressed mood. Participants will complete assessments on four occasions - baseline, five-weeks post-baseline, and six- and 12-month post-baseline. Analyses will compare outcomes in the intervention compared to the control group. This study will be the first to implement a RCT design to evaluate the impact of a school-based social media literacy program designed to mitigate negative impacts of social media.",2020,"This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles.","['grades 7-8 students from Australian secondary schools', 'adolescent boys and girls']","['SoMe program (intervention) or health lessons as usual (control', 'SoMe social media literacy body image and wellbeing program']","['body satisfaction, dietary restraint, and strategies to increase muscles', 'self-esteem and depressed mood']","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}]",,0.0798022,"This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles.","[{'ForeName': 'Chloe S', 'Initials': 'CS', 'LastName': 'Gordon', 'Affiliation': 'La Trobe University, Victoria, Australia. Electronic address: c.gordon@latrobe.edu.au.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Rodgers', 'Affiliation': 'Northeastern University, Boston, MA, USA; Department of Psychiatric Emergency & Acute Care, Lapeyronie Hospital, CHRU, Montpellier, France.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Slater', 'Affiliation': 'Centre for Appearance Research, University of West of England, Bristol, England, United Kingdom.'}, {'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'McLean', 'Affiliation': 'La Trobe University, Victoria, Australia; Victoria University, Australia.'}, {'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Jarman', 'Affiliation': 'La Trobe University, Victoria, Australia.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Paxton', 'Affiliation': 'La Trobe University, Victoria, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.003']
235,31484659,"A Randomized, Placebo-Controlled, Double-Blind, Dose Escalation, Single Dose, and Steady-State Pharmacokinetic Study of 9cUAB30 in Healthy Volunteers.","9cUAB30 is a synthetic analogue of 9-cis retinoic acid with chemoprevention activity in cell lines and animal models. The purpose of this phase I placebo-controlled, double-blinded, dose escalation study of 9cUAB30 was to evaluate its safety, pharmacokinetics, and determine a dose for future phase II studies. Participants received a single dose of study drug (placebo or 9cUAB30) on day 1 followed by a 6-day drug-free period and then 28 days of continuous daily dosing starting on day 8. Fifty-three healthy volunteers were enrolled into five dose cohorts (20, 40, 80, 160, and 240 mg). Participants were randomized within each dose level to receive either 9cUAB30 ( n = 8) or placebo ( n = 2). 9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol. Treatment-emergent grade 3 hypertension occurred in 1 of 8 participants at the 20 mg dose level and in 2 of 8 at the 240 mg dose level, all considered unlikely related to study agent; no other grade 3 adverse events were observed. The AUC increased, as expected, between day 1 (single dose) and day 36 (steady state). Pharmacokinetics were linear in dose escalation through 160 mg. 9cUAB30 administered by daily oral dosing has a favorable safety and pharmacokinetic profile. On the basis of the observed safety profile and lack of linearity in pharmacokinetics at doses greater than 160 mg, the recommended phase II dose with the current formulation is 160 mg once daily.",2019,"9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol.","['Healthy Volunteers', 'Fifty-three healthy volunteers']","['placebo', 'Placebo', '9cUAB30', 'drug (placebo or 9cUAB30']","['grade 3 adverse events', 'serum triglycerides or cholesterol', 'grade 3 hypertension']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1311390', 'cui_str': '(9Z)-UAB30'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",53.0,0.180973,"9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol.","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Kolesar', 'Affiliation': 'College of Pharmacy, University of Kentucky, Lexington, Kentucky. jill.kolesar@uky.edu hhb@medicine.wisc.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Andrews', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Green', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Tom C', 'Initials': 'TC', 'LastName': 'Havighurst', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Barbara W', 'Initials': 'BW', 'LastName': 'Wollmer', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Katina', 'Initials': 'K', 'LastName': 'DeShong', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Laux', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Krontiras', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'Muccio', 'Affiliation': 'Biochemistry and Molecular Genetics, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Grubbs', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'House', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Parnes', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Brandy M', 'Initials': 'BM', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Bailey', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin. jill.kolesar@uky.edu hhb@medicine.wisc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0310']
236,31699604,Family-Based Mental Health Promotion for Somali Bantu and Bhutanese Refugees: Feasibility and Acceptability Trial.,"PURPOSE
There are disparities in mental health of refugee youth compared with the general U.S.
POPULATION
We conducted a pilot feasibility and acceptability trial of the home-visiting Family Strengthening Intervention for refugees (FSI-R) using a community-based participatory research approach. The FSI-R aims to promote youth mental health and family relationships. We hypothesized that FSI-R families would have better psychosocial outcomes and family functioning postintervention compared with care-as-usual (CAU) families. We hypothesized that FSI-R would be feasible to implement and accepted by communities.
METHODS
A total of 40 Somali Bantu (n = 103 children, 58.40% female; n = 43 caregivers, 79.00% female) and 40 Bhutanese (n = 49 children, 55.30% female; n = 62 caregivers, 54.00% female) families were randomized to receive FSI-R or CAU. Refugee research assistants conducted psychosocial assessments pre- and post-intervention, and home visitors delivered the preventive intervention. Multilevel modeling assessed the effects of FSI-R. Feasibility was measured from retention, and acceptability was measured from satisfaction surveys.
RESULTS
The retention rate of 82.50% indicates high feasibility, and high reports of satisfaction (81.50%) indicate community acceptance. Across communities, FSI-R children reported reduced traumatic stress reactions, and caregivers reported fewer child depression symptoms compared with CAU families (β = -.42; p = .03; β = -.34; p = .001). Bhutanese FSI-R children reported reduced family arguing (β = -1.32; p = .04) and showed fewer depression symptoms and conduct problems by parent report (β = -9.20; p = .04; β = -.92; p = .01) compared with CAU. There were no significant differences by group on other measures.
CONCLUSIONS
A family-based home-visiting preventive intervention can be feasible and acceptable and has promise for promoting mental health and family functioning among refugees.",2020,We hypothesized that FSI-R families would have better psychosocial outcomes and family functioning postintervention compared with care-as-usual (CAU) families.,"['A total of 40 Somali Bantu (n\xa0= 103 children, 58.40% female; n\xa0= 43 caregivers, 79.00% female) and 40 Bhutanese (n\xa0= 49 children, 55.30% female; n\xa0= 62 caregivers, 54.00% female) families', 'Family-Based Mental Health Promotion for Somali Bantu and Bhutanese Refugees']","['FSI-R or CAU', 'home-visiting Family Strengthening Intervention']","['FSI-R. Feasibility', 'child depression symptoms', 'retention rate', 'depression symptoms and conduct problems', 'traumatic stress reactions']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337847', 'cui_str': 'Somalis (ethnic group)'}, {'cui': 'C0337826', 'cui_str': 'Bantu (ethnic group)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0337894', 'cui_str': 'Bhutanese (ethnic group)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",103.0,0.150707,We hypothesized that FSI-R families would have better psychosocial outcomes and family functioning postintervention compared with care-as-usual (CAU) families.,"[{'ForeName': 'Theresa S', 'Initials': 'TS', 'LastName': 'Betancourt', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts. Electronic address: theresa.betancourt@bc.edu.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Berent', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Rochelle L', 'Initials': 'RL', 'LastName': 'Frounfelker', 'Affiliation': 'Division of Social and Transcultural Psychiatry, Department of Psychiatry, McGill University, Montreal, Canada.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Brennan', 'Affiliation': ""Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts; Women's Studies Research Center, Brandeis University, Waltham, Massachusetts.""}, {'ForeName': 'Saida', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': ""Refugee Trauma and Resilience Center, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Maalim', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Abdirahman', 'Initials': 'A', 'LastName': 'Abdi', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Tej', 'Initials': 'T', 'LastName': 'Mishra', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Bhuwan', 'Initials': 'B', 'LastName': 'Gautam', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Creswell', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, St. Ann Arbor, Michigan; College of Education and Human Services, University of Nebraska-Lincoln, Lincoln, Nebraska.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Beardslee', 'Affiliation': ""College of Education and Human Services, University of Nebraska-Lincoln, Lincoln, Nebraska; Judge Baker Children's Center, Harvard University, Boston, Massachusetts.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.08.023']
237,30870159,Intravenous Lidocaine Does Not Improve Neurologic Outcomes after Cardiac Surgery: A Randomized Controlled Trial.,"BACKGROUND
Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest that intravenous lidocaine may confer protection in the setting of neurologic injury. It was hypothesized that lidocaine administration would reduce cognitive decline after cardiac surgery compared to placebo.
METHODS
After institutional review board approval, 478 patients undergoing cardiac surgery were enrolled into this multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group trial. Subjects were randomized to lidocaine 1 mg/kg bolus after the induction of anesthesia followed by a continuous infusion (48 μg · kg · min for the first hour, 24 μg · kg · min for the second hour, and 10 μg · kg · min for the next 46 h) or saline with identical volume and rate changes to preserve blinding. Cognitive function was assessed preoperatively and at 6 weeks and 1 yr postoperatively using a standard neurocognitive test battery. The primary outcome was change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type.
RESULTS
Among the 420 allocated subjects who returned for 6-week follow-up (lidocaine: N = 211; placebo: N = 209), there was no difference in the continuous cognitive score change (adjusted mean difference [95% CI], 0.02 (-0.05, 0.08); P = 0.626). Cognitive deficit (greater than 1 SD decline in at least one cognitive domain) at 6 weeks occurred in 41% (87 of 211) in the lidocaine group versus 40% (83 of 209) in the placebo group (adjusted odds ratio [95% CI], 0.94 [0.63, 1.41]; P = 0.766). There were no differences in any quality of life outcomes between treatment groups. At the 1-yr follow-up, there continued to be no difference in cognitive score change, cognitive deficit, or quality of life.
CONCLUSIONS
Intravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks.",2019,This multicenter trial of intravenous lidocaine administered during and after cardiac surgery did not show an effect on cognition at 6 weeks postoperatively BACKGROUND:: Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients.,"['after Cardiac Surgery', '478 patients undergoing cardiac surgery', 'surgical patients at risk of neurologic compromise']","['lidocaine', 'Intravenous Lidocaine', 'placebo']","['continuous cognitive score change', 'cognitive score change, cognitive deficit, or quality of life', 'postoperative cognitive decline', 'Cognitive function', 'quality of life outcomes', 'Neurologic Outcomes', 'Cognitive deficit', 'change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type', 'cognitive decline']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0034380'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0455713', 'cui_str': 'Procedure type (qualifier value)'}]",478.0,0.728607,This multicenter trial of intravenous lidocaine administered during and after cardiac surgery did not show an effect on cognition at 6 weeks postoperatively BACKGROUND:: Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients.,"[{'ForeName': 'Rebecca Y', 'Initials': 'RY', 'LastName': 'Klinger', 'Affiliation': 'From the Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina (R.Y.K., M.C., T.B., N.T., M.B., M.V.P., M.S.-S., J.P.M.) the Department of Anesthesiology, University of Kentucky School of Medicine, Lexington, Kentucky (M.F.N.).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cooter', 'Affiliation': ''}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Bisanar', 'Affiliation': ''}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Terrando', 'Affiliation': ''}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': ''}, {'ForeName': 'Mihai V', 'Initials': 'MV', 'LastName': 'Podgoreanu', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stafford-Smith', 'Affiliation': ''}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Mathew', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000002668']
238,32317873,Efficacy of erector spinae plane block for postoperative analgesia in total mastectomy and axillary clearance: A randomized controlled trial.,"Background
The erector spinae plane block is a newer technique of analgesia to the chest wall.
Objective
The study was carried out to establish the efficacy and safety of this block in patients undergoing total mastectomy and axillary clearance.
Design
Prospective randomized controlled study.
Setting
Single tertiary care center, the study was conducted over a period of 1 year.
Patients
65 patients were included; final analysis was done for 60 female patients undergoing total mastectomy and axillary clearance under general anesthesia were randomly allocated to two groups.
Intervention
Group B (block group) received ultrasound-guided erector spinae plane block at T5 level with ropivacaine (0.5%, 0.4 mL/kg) while the control group did not receive any intervention. Postoperatively, patients in both groups received morphine via intravenous patient-controlled analgesia device. Patients were followed up for 24 h postoperatively.
Main Outcome Measures
The 24-hour morphine consumption was considered as the primary outcome and secondary outcomes included time to first rescue analgesia, pain scores at 0, ½, 1, 2, 4, 6, 8, 12, and 24 h and characteristics and complications associated with block procedure.
Results
The 24-hour morphine consumption was 42% lower in block group compared to control group [mean (SD), 2.9 (2.5) mg vs 5.0 (2.1) mg in group B and group C, respectively, P = 0.01]. The postoperative pain score was lower in group B vs group C at 0, 1/2, 1, 2, 4, 6, 12, and 24 h ( P < 0.05). 26 patients in group C against 14 in group B used rescue analgesia within 1 h of surgery ( P = 0.01).
Conclusion
Erector spinae block may prove to be a safe and reliable technique of analgesia for breast surgery. Further studies comparing this technique with other regional techniques are required to identify the most appropriate technique.",2020,"The postoperative pain score was lower in group B vs group C at 0, 1/2, 1, 2, 4, 6, 12, and 24 h ( P < 0.05).","['patients undergoing total mastectomy and axillary clearance', 'total mastectomy and axillary clearance', 'Patients\n\n\n65 patients were included; final analysis was done for 60 female patients undergoing total mastectomy and axillary clearance under general anesthesia']","['Intervention\n\n\nGroup B (block group) received ultrasound-guided erector spinae plane block at T5 level with ropivacaine', 'control group did not receive any intervention', 'morphine via intravenous patient-controlled analgesia device', 'erector spinae plane block']","['postoperative pain score', 'efficacy and safety', 'rescue analgesia', 'time to first rescue analgesia, pain scores at 0, ½, 1, 2, 4, 6, 8, 12, and 24 h and characteristics and complications associated with block procedure', '24-hour morphine consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960429', 'cui_str': 'Total mastectomy and axillary clearance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0446423', 'cui_str': 'Level of the fifth thoracic vertebra'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",65.0,0.0788328,"The postoperative pain score was lower in group B vs group C at 0, 1/2, 1, 2, 4, 6, 12, and 24 h ( P < 0.05).","[{'ForeName': 'Shashikant', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh, India.'}, {'ForeName': 'Anudeep', 'Initials': 'A', 'LastName': 'Jafra', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh, India.'}, {'ForeName': 'Gurpreet', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_625_19']
239,32317876,Is video laryngoscopy easier than direct laryngoscopy for intubation in patients with contracture neck?,"Background and Objective
Postburn contracture (PBC) of the neck is commonly seen after acute burn in the face and neck region. Managing the airway is a challenge due to functional and anatomical deformities. We compared the ease of intubation using video and direct laryngoscopes.
Material and Methods
Eighty patients, 18-60 years of age with ASA physical status I/II with Onah's types 1 and 2 contracture of the neck were randomized in this study. Group DL were intubated by direct laryngoscopy (DL) using Macintosh blade and Group VL by video laryngoscopy (VL) using King Vision. The outcome measures were ease of intubation (EOI), Cormack-Lehane (CL) grading, and associated complications if any.
Results
EOI score was significantly lower in group VL (0.42 ± 0.84) as compared to group DL (0.85 ± 1.21) ( P = 0.048) as was the use of external maneuvers (group VL: 17.5%; group DL: 42.5%; P = 0.015), and the use of stylet (group VL: 0%; group DL: 20%, P = 0.005). CL grading improved significantly in group VL ( P < 0.001). Occurrence of complications was negligible in both the groups. A single failure in group DL needed rescue intubation.
Conclusion
Intubation with a video laryngoscope was easier than with DL in patients with mild-to-moderate contracture neck with mouth opening >3 cm and MPG I/II.",2020,"Results
EOI score was significantly lower in group VL (0.42 ± 0.84) as compared to group DL (0.85 ± 1.21) (","[""Eighty patients, 18-60 years of age with ASA physical status I/II with Onah's types"", 'acute burn in the face and neck region', 'patients with contracture neck']","['direct laryngoscopy', 'video laryngoscope', 'direct laryngoscopy (DL) using Macintosh blade and Group VL by video laryngoscopy (VL) using King Vision']","['EOI score', 'CL grading', 'ease of intubation (EOI), Cormack-Lehane (CL) grading, and associated complications if any', 'Occurrence of complications']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}]","[{'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",80.0,0.0665881,"Results
EOI score was significantly lower in group VL (0.42 ± 0.84) as compared to group DL (0.85 ± 1.21) (","[{'ForeName': 'Roopali', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Ameeta', 'Initials': 'A', 'LastName': 'Sahni', 'Affiliation': 'Department of Anesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_808_19']
240,31826336,"Early High-Dose Vitamin D 3 for Critically Ill, Vitamin D-Deficient Patients.","BACKGROUND
Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study.
METHODS
We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D 3 supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D 3 or matched placebo. The primary end point was 90-day all-cause, all-location mortality.
RESULTS
A total of 1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population. The mean day 3 level of 25-hydroxyvitamin D was 46.9±23.2 ng per milliliter (117±58 nmol per liter) in the vitamin D group and 11.4±5.6 ng per milliliter (28±14 nmol per liter) in the placebo group (difference, 35.5 ng per milliliter; 95% confidence interval [CI], 31.5 to 39.6). The 90-day mortality was 23.5% in the vitamin D group (125 of 531 patients) and 20.6% in the placebo group (109 of 528 patients) (difference, 2.9 percentage points; 95% CI, -2.1 to 7.9; P = 0.26). There were no clinically important differences between the groups with respect to secondary clinical, physiological, or safety end points. The severity of vitamin D deficiency at baseline did not affect the association between the treatment assignment and mortality.
CONCLUSIONS
Early administration of high-dose enteral vitamin D 3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients. (Funded by the National Heart, Lung, and Blood Institute; VIOLET ClinicalTrials.gov number, NCT03096314.).",2019,"Early administration of high-dose enteral vitamin D 3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients.","['critically ill, vitamin D-deficient patients who were at high risk for death', 'Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population', '1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization', 'critically ill, vitamin D-deficient patients', 'Critically Ill, Vitamin D-Deficient Patients', 'critically ill patients']","['single enteral dose of 540,000 IU of vitamin D 3 or matched placebo', 'vitamin D supplementation', 'placebo', 'early vitamin D 3 supplementation', 'vitamin D']","['90-day mortality', '90-day mortality or other, nonfatal outcomes', '90-day all-cause, all-location mortality', 'mean day 3 level of 25-hydroxyvitamin D', 'severity of vitamin D deficiency']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]",1360.0,0.763031,"Early administration of high-dose enteral vitamin D 3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Caterino', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Finck', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Colin K', 'Initials': 'CK', 'LastName': 'Grissom', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hayden', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hyzy', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Levitt', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ringwood', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Emanuel P', 'Initials': 'EP', 'LastName': 'Rivers', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Talmor', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}]",The New England journal of medicine,['10.1056/NEJMoa1911124']
241,31643041,Effect of Simvastatin on Permeability in Cerebral Cavernous Malformation Type 1 Patients: Results from a Pilot Small Randomized Controlled Clinical Trial.,,2020,,['Cerebral Cavernous Malformation Type 1 Patients'],['Simvastatin'],[],"[{'cui': 'C2919945', 'cui_str': 'Familial Cavernous Malformation'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}]",[],,0.177976,,"[{'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Mabray', 'Affiliation': 'Department of Radiology, University of New Mexico Health Sciences Center, University of New Mexico, MSC 10 5530, 1 University of New Mexico, Albuquerque, NM, 87131, USA. mamabray@salud.unm.edu.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Caprihan', 'Affiliation': 'Mind Research Network, Albuquerque, NM, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, University of New Mexico Health Sciences Center, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Blaine L', 'Initials': 'BL', 'LastName': 'Hart', 'Affiliation': 'Department of Radiology, University of New Mexico Health Sciences Center, University of New Mexico, MSC 10 5530, 1 University of New Mexico, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Department of Neurology, University of New Mexico Health Sciences Center, University of New Mexico, Albuquerque, NM, USA.'}]",Translational stroke research,['10.1007/s12975-019-00737-4']
242,32062021,"The effect of Instagram #fitspiration images on young women's mood, body image, and exercise behaviour.","The present study experimentally examined the effects of viewing Instagram images of fitspiration on body dissatisfaction, mood, and exercise behaviour among young women. Further, the study investigated if exercise engagement following exposure to fitspiration images could mitigate any negative effects from image exposure. Participants were 108 women, aged 17-25 years, who were randomly assigned to a 2 (image type: fitspiration, travel inspiration) × 2 (activity type: exercise, quiet rest) between groups design. State body dissatisfaction and mood were assessed at baseline, following image exposure, and following participation in 10 min of walking or quiet rest. Results demonstrated that exposure to fitspiration images led to significantly higher negative mood and body dissatisfaction relative to exposure to travel images. There was no difference in actual exercise behaviour according to image type. However, participants who exercised following exposure to fitspiration images were significantly more likely to report higher subjective exertion ratings. Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition. These findings provide further evidence highlighting fitspiration as a potentially harmful online trend.",2020,"Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition.","[""young women's mood, body image, and exercise behaviour"", 'Participants were 108 women, aged 17-25 years', 'young women']","['2 (image type: fitspiration, travel inspiration']","['actual exercise behaviour', 'body dissatisfaction, mood, and exercise behaviour', 'Overall, negative mood and body dissatisfaction', 'subjective exertion ratings']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0429689', 'cui_str': 'Exertion rating (staging scale)'}]",108.0,0.0528909,"Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition.","[{'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Prichard', 'Affiliation': 'Health & Exercise Sciences, College of Nursing & Health Sciences, Flinders University, Adelaide, South Australia, Australia; SHAPE Research Centre, Flinders University, Adelaide, South Australia, Australia. Electronic address: ivanka.prichard@flinders.edu.au.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Kavanagh', 'Affiliation': 'Psychology, College of Education, Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Maroochydore, Australia.'}, {'ForeName': 'Megan S C', 'Initials': 'MSC', 'LastName': 'Lim', 'Affiliation': 'Burnet Institute, 85 Commercial Rd, Melbourne, Australia; School of Population Health and Preventive Medicine, Monash University, Melbourne, Australia; Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Psychology, College of Education, Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.002']
243,32145674,"A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents.","AIM
The aim of this study was to determine the efficacy and safety of cranial electrotherapy stimulation (CES) as an add-on treatment for TD.
METHODS
A randomized, double-blind, sham-controlled trial was conducted at an outpatient, single-center academic setting. A total of 62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled. Patients were divided randomly into 2 groups and given 4 weeks' treatment, including 30 min sessions of active CES (500 μA-2 mA) or sham CES (lower than 100 μA) per day for 40 d on weekdays. Change in Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety Scale-14 items (HAMA-14) were performed at baseline, week 2, week 4. Adverse events (AEs) were also evaluated.
RESULTS
53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group. Both groups showed clinical improvement in tic severities compared to baseline respectively at week 4. Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
CONCLUSION
Four-week's treatment of CES for children and adolescents with TD is effective and safe, but the improvement for tic severity may be related to placebo effect.",2020,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[""62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled"", 'tic disorders in children and adolescents', '53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group']","['cranial electrotherapy stimulation', 'active CES', 'cranial electrotherapy stimulation (CES', 'active CES (500\u2009μA-2\u2009mA) or sham CES']","['clinical improvement in tic severities', 'Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety', 'efficacy and safety', 'Adverse events (AEs', 'YGTSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.38816,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[{'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: wenjun104@126.com.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: fgx995@163.com.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: caimin@fmmu.edu.cn.""}, {'ForeName': 'Yi-Huan', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: 182368179@qq.com.""}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Zhou', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: zch4610@126.com.""}, {'ForeName': 'Hua-Ning', 'Initials': 'HN', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: xskzhu@fmmu.edu.cn.""}, {'ForeName': 'Long-Biao', 'Initials': 'LB', 'LastName': 'Cui', 'Affiliation': ""Department of Clinical Psychology, School of Medical Psychology, Fourth Military Medical University, 169 # West Changle Road, Xi'an, 710032, China. Electronic address: lbcui@fmmu.edu.cn.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.101992']
244,32145825,"Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial.","BACKGROUND
Urothelial carcinomas of the upper urinary tract (UTUCs) are rare, with poorer stage-for-stage prognosis than urothelial carcinomas of the urinary bladder. No international consensus exists on the benefit of adjuvant chemotherapy for patients with UTUCs after nephroureterectomy with curative intent. The POUT (Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer) trial aimed to assess the efficacy of systemic platinum-based chemotherapy in patients with UTUCs.
METHODS
We did a phase 3, open-label, randomised controlled trial at 71 hospitals in the UK. We recruited patients with UTUC after nephroureterectomy staged as either pT2-T4 pN0-N3 M0 or pTany N1-3 M0. We randomly allocated participants centrally (1:1) to either surveillance or four 21-day cycles of chemotherapy, using a minimisation algorithm with a random element. Chemotherapy was either cisplatin (70 mg/m 2 ) or carboplatin (area under the curve [AUC]4·5/AUC5, for glomerular filtration rate <50 mL/min only) administered intravenously on day 1 and gemcitabine (1000 mg/m 2 ) administered intravenously on days 1 and 8; chemotherapy was initiated within 90 days of surgery. Follow-up included standard cystoscopic, radiological, and clinical assessments. The primary endpoint was disease-free survival analysed by intention to treat with a Peto-Haybittle stopping rule for (in)efficacy. The trial is registered with ClinicalTrials.gov, NCT01993979. A preplanned interim analysis met the efficacy criterion for early closure after recruitment of 261 participants.
FINDINGS
Between June 19, 2012, and Nov 8, 2017, we enrolled 261 participants from 57 of 71 open study sites. 132 patients were assigned chemotherapy and 129 surveillance. One participant allocated chemotherapy withdrew consent for data use after randomisation and was excluded from analyses. Adjuvant chemotherapy significantly improved disease-free survival (hazard ratio 0·45, 95% CI 0·30-0·68; p=0·0001) at a median follow-up of 30·3 months (IQR 18·0-47·5). 3-year event-free estimates were 71% (95% CI 61-78) and 46% (36-56) for chemotherapy and surveillance, respectively. 55 (44%) of 126 participants who started chemotherapy had acute grade 3 or worse treatment-emergent adverse events, which accorded with frequently reported events for the chemotherapy regimen. Five (4%) of 129 patients managed by surveillance had acute grade 3 or worse emergent adverse events. No treatment-related deaths were reported.
INTERPRETATION
Gemcitabine-platinum combination chemotherapy initiated within 90 days after nephroureterectomy significantly improved disease-free survival in patients with locally advanced UTUC. Adjuvant platinum-based chemotherapy should be considered a new standard of care after nephroureterectomy for this patient population.
FUNDING
Cancer Research UK.",2020,"Adjuvant chemotherapy significantly improved disease-free survival (hazard ratio 0·45, 95% CI 0·30-0·68; p=0·0001) at a median follow-up of 30·3 months (IQR 18·0-47·5).","['261 participants from 57 of 71 open study sites', 'patients with UTUCs after nephroureterectomy with curative intent', '132 patients were assigned chemotherapy and 129 surveillance', 'patients with locally advanced UTUC', 'Between June 19, 2012, and Nov 8, 2017', 'patients with UTUCs.\nMETHODS', 'upper tract urothelial carcinoma', 'patients with UTUC after nephroureterectomy staged as either', '261 participants', '71 hospitals in the UK']","['Chemotherapy', 'systemic platinum-based chemotherapy', 'surveillance or four 21-day cycles of chemotherapy', 'Adjuvant chemotherapy', 'AUC]4·5/AUC5', 'Adjuvant platinum-based chemotherapy', 'carboplatin (area under the curve', 'gemcitabine', 'POUT (Peri-Operative chemotherapy', 'Gemcitabine-platinum combination chemotherapy', 'cisplatin', 'pT2-T4 pN0-N3 M0 or pTany N1-3 M0']","['glomerular filtration rate', 'acute grade 3 or worse treatment-emergent adverse events', 'disease-free survival', '3-year event-free estimates', 'acute grade 3 or worse emergent adverse events', 'disease-free survival analysed by intention to treat with a Peto-Haybittle stopping rule for (in)efficacy']","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027732', 'cui_str': 'Ureteronephrectomy'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4042485', 'cui_str': 'Pt(acac)2'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]",261.0,0.473338,"Adjuvant chemotherapy significantly improved disease-free survival (hazard ratio 0·45, 95% CI 0·30-0·68; p=0·0001) at a median follow-up of 30·3 months (IQR 18·0-47·5).","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK; University of Manchester, Manchester, UK. Electronic address: alison.birtle@lthtr.nhs.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chester', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dolling', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Bryan', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Patient and Public Involvement Representative, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Winterbottom', 'Affiliation': 'Patient and Public Involvement Representative, Fight Bladder Cancer, Chinnor, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Blacker', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Prabir', 'Initials': 'P', 'LastName': 'Chakraborti', 'Affiliation': 'Derby Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul Anthony', 'Initials': 'PA', 'LastName': 'Elliott', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'French', 'Affiliation': 'Southend University Hospital NHS Foundation Trust, Southend, UK.'}, {'ForeName': 'Satinder', 'Initials': 'S', 'LastName': 'Jagdev', 'Affiliation': 'The Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Jenkins', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Francis Xavier', 'Initials': 'FX', 'LastName': 'Keeley', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'Singleton Hospital, Swansea, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Todd', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30415-3']
245,31377868,"The effects of Tiszasüly and Kolop mud pack therapy on knee osteoarthritis: a double-blind, randomised, non-inferiority controlled study.","The aim of this non-inferiority study was to evaluate and compare the effects of Tiszasüly and Kolop mud pack therapy on pain, function and quality of life in patients with knee osteoarthritis. In this double-blind, randomised, follow-up study, 60 patients with knee osteoarthritis were treated with either Tiszasüly hot mud pack (group 1) or with Kolop hot mud pack (group 2) on 10 occasions for 2 weeks (10 working days). One hundred millimetre visual analogue scale (VAS) for knee pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Lequesne Index for physical function and EuroQoL-5D for quality-of-life measurements were recorded at baseline, at the end of treatment (week 2) and 3 months later (week 12). In both groups, all measured parameters improved significantly from the baseline until the end of treatment and during the follow-up period (p < 0.05). There were no significant differences between the groups in terms of the WOMAC, KOOS, EQ-5D and Lequesne Index at any visits. Knee pain improved in both groups at week 2 and week 12; the only significant difference visible between the groups was at the end of the treatment in favour of the Tiszasüly mud pack group (p = 0.009). Tiszasüly and Kolop mud packs both have a favourable effect on knee pain, physical function and quality of life in patients with knee osteoarthritis. Our results proved non-inferiority of Tiszasüly mud pack.",2020,"There were no significant differences between the groups in terms of the WOMAC, KOOS, EQ-5D and Lequesne Index at any visits.","['patients with knee osteoarthritis', '60 patients with knee osteoarthritis', 'knee osteoarthritis']","['Tiszasüly and Kolop mud pack therapy', 'Tiszasüly hot mud pack (group 1) or with Kolop hot mud pack']","['WOMAC, KOOS, EQ-5D and Lequesne Index', 'pain, function and quality of life', 'millimetre visual analogue scale (VAS) for knee pain, the Western Ontario and McMaster Universities Arthritis Index', 'knee pain, physical function and quality of life', 'Lequesne Index for physical function and EuroQoL-5D for quality-of-life measurements', 'Knee pain', 'WOMAC), the Knee injury and Osteoarthritis Outcome Score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0949364', 'cui_str': 'Mud Packs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0439200', 'cui_str': 'mm'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0480853,"There were no significant differences between the groups in terms of the WOMAC, KOOS, EQ-5D and Lequesne Index at any visits.","[{'ForeName': 'Márta', 'Initials': 'M', 'LastName': 'Király', 'Affiliation': 'Petz Aladár County Teaching Hospital, Híd u.2., Győr, H-9025, Hungary.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Kővári', 'Affiliation': 'School of PhD Studies, Semmelweis University, Üllői út 26., Budapest, H-1085, Hungary.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Hodosi', 'Affiliation': 'Medical and Health Science Center, University of Debrecen, Nagyerdei körút 98., Debrecen, H-4012, Hungary.'}, {'ForeName': 'Péter V', 'Initials': 'PV', 'LastName': 'Bálint', 'Affiliation': '3rd Rheumatology Department, National Institute of Rheumatology and Physiotherapy, Frankel L. u. 25-29., Budapest, H-1023, Hungary.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Bender', 'Affiliation': 'Polyclinic of Hospitaller Brothers of St. John of God, Árpád fejedelem útja 7., Budapest, H-1023, Hungary. bender.tamas@irgalmas.hu.'}]",International journal of biometeorology,['10.1007/s00484-019-01764-4']
246,32194251,Slow release oral morphine versus methadone for opioid use disorder in the fentanyl era (pRESTO): Protocol for a non-inferiority randomized clinical trial.,"BACKGROUND
North America is facing an unprecedented public health crisis of opioid-related morbidity and mortality, increasingly as a result of the introduction of illicitly manufactured fentanyl into the street drug market. Although the treatment of opioid use disorder (OUD) is a key element in the response to the opioid overdose epidemic, currently available pharmacotherapies (e.g., methadone, buprenorphine) may not be acceptable to or effective in all patients. Available evidence suggests that slow-release oral morphine (SROM) has similar efficacy rates as methadone with respect to promoting abstinence, and with improvements in a number of patient-reported outcomes among persons using heroin. However, little is known about the relative effectiveness and acceptability of SROM compared to methadone in the context of fentanyl use. This study aims to address this research gap.
METHODS
pRESTO is a 24-week, open-label, two arm, non-inferiority, randomized controlled trial comparing SROM versus methadone for the treatment of OUD. Participants will be 298 clinically stable, non-pregnant adults with OUD, recruited from outpatient clinics in Vancouver, Canada, where the majority of the illicit opioids are contaminated with fentanyl. The primary outcome is suppression of illicit opioid use, measured by bi-weekly urine drug screens. Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
DISCUSSION
pRESTO will be among the first studies to evaluate treatment options for individuals primarily using synthetic street opioids, providing important evidence to guide treatment strategies for this population.",2020,"Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
","['Participants will be 298 clinically stable, non-pregnant adults with OUD, recruited from outpatient clinics in Vancouver, Canada, where the majority of the illicit opioids are contaminated with fentanyl']","['methadone, buprenorphine', 'methadone', 'morphine', 'morphine (SROM']","['suppression of illicit opioid use, measured by bi-weekly urine drug screens', 'efficacy rates', ' treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205279', 'cui_str': 'Contaminated (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",298.0,0.110341,"Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
","[{'ForeName': 'M Eugenia', 'Initials': 'ME', 'LastName': 'Socias', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada. Electronic address: bccsu-es@bccsu.ubc.ca.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Huiru', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Rupinder', 'Initials': 'R', 'LastName': 'Brar', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Paxton', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Fairbairn', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105993']
247,31499528,Menopausal Estrogen-Alone Therapy and Health Outcomes in Women With and Without Bilateral Oophorectomy: A Randomized Trial.,"Background
Whether health outcomes of menopausal estrogen therapy differ between women with and without bilateral salpingo-oophorectomy (BSO) is unknown.
Objective
To examine estrogen therapy outcomes by BSO status, with additional stratification by 10-year age groups.
Design
Subgroup analyses of the randomized Women's Health Initiative Estrogen-Alone Trial. (ClinicalTrials.gov: NCT00000611).
Setting
40 U.S. clinical centers.
Participants
9939 women aged 50 to 79 years with prior hysterectomy and known oophorectomy status.
Intervention
Conjugated equine estrogens (CEE) (0.625 mg/d) or placebo for a median of 7.2 years.
Measurements
Incidence of coronary heart disease and invasive breast cancer (the trial's 2 primary end points), all-cause mortality, and a ""global index"" (these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture) during the intervention phase and 18-year cumulative follow-up.
Results
The effects of CEE alone did not differ significantly according to BSO status. However, age modified the effect of CEE in women with prior BSO. During the intervention phase, CEE was significantly associated with a net adverse effect (hazard ratio for global index, 1.42 [95% CI, 1.09 to 1.86]) in older women (aged ≥70 years), but the global index was not elevated in younger women (P trend by age = 0.016). During cumulative follow-up, women aged 50 to 59 years with BSO had a treatment-associated reduction in all-cause mortality (hazard ratio, 0.68 [CI, 0.48 to 0.96]), whereas older women with BSO had no reduction (P trend by age = 0.034). There was no significant association between CEE and outcomes among women with conserved ovaries, regardless of age.
Limitations
The timing of CEE in relation to BSO varied; several comparisons were made without adjustment for multiple testing.
Conclusion
The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age. Among women with prior BSO, in those aged 70 years or older, CEE led to adverse effects during the treatment period, whereas women randomly assigned to CEE before age 60 seemed to derive mortality benefit over the long term.
Primary Funding Source
The WHI program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and U.S. Department of Health and Human Services. Wyeth Ayerst donated the study drugs.",2019,"The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age.","['women with prior BSO', 'women aged 50 to 79 years with prior hysterectomy and known oophorectomy status', 'Participants\n\n\n9939', 'women with and without bilateral salpingo-oophorectomy (BSO', 'women with prior BSO, in those aged 70 years or older, CEE', 'Women']","['Intervention\n\n\nConjugated equine estrogens (CEE', 'Bilateral Oophorectomy', 'Menopausal Estrogen-Alone Therapy', 'CEE', 'placebo', 'menopausal estrogen therapy']","['global index', 'cause mortality', 'BSO status', 'coronary heart disease and invasive breast cancer', 'mortality benefit', 'cause mortality, and a ""global index"" (these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0029936', 'cui_str': 'Oophorectomy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0046018', 'cui_str': 'CEES'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C0278321', 'cui_str': 'Castration, Female'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279494'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}]",,0.296687,"The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age.","[{'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (J.E.M., S.S.B.).""}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (A.K.A., G.L.A., R.L.P.).'}, {'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Bassuk', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (J.E.M., S.S.B.).""}, {'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'City of Hope National Medical Center, Duarte, and Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California (R.T.C.).'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (A.K.A., G.L.A., R.L.P.).'}, {'ForeName': 'Jacques E', 'Initials': 'JE', 'LastName': 'Rossouw', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, Maryland (J.E.R.).'}, {'ForeName': 'Barbara V', 'Initials': 'BV', 'LastName': 'Howard', 'Affiliation': 'MedStar Health Research Institute, Bonita Springs, Florida, and Georgetown-Howard Universities, Washington, DC (B.V.H.).'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'Mel & Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona (C.A.T.).'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Stanford Prevention Research Center, Stanford, California (M.L.S.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida (A.M.K.).'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Crandall', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California (C.J.C.).'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Eaton', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island (C.B.E., S.L.).'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Henderson', 'Affiliation': 'Stanford University, Stanford, California (V.W.H.).'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island (C.B.E., S.L.).'}, {'ForeName': 'Juhua', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Brown University, Providence, Rhode Island; Indiana University, Bloomington, Indiana (J.L.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rohan', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York (T.R.).'}, {'ForeName': 'Aladdin H', 'Initials': 'AH', 'LastName': 'Shadyab', 'Affiliation': 'University of California, San Diego School of Medicine, La Jolla, California (A.H.S.).'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'University of Kentucky, Lexington, Kentucky (G.W.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'University at Buffalo, the State University of New York, Buffalo, New York (J.W.).'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (A.K.A., G.L.A., R.L.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-0274']
248,32331937,EPO treatment does not alter acute serum profiles of GFAP and S100B after TBI: A brief report on the Australian EPO-TBI clinical trial.,"PURPOSE
To determine the diagnostic and prognostic value of glial fibrillary acidic protein (GFAP) and S100B after traumatic brain injury (TBI) in an Erythropoietin (EPO) clinical trial and examine whether EPO therapy reduces biomarker concentrations.
MATERIALS AND METHODS
Forty-four patients with moderate-to-severe TBI were enrolled to a sub-study of the EPO-TBI trial. Patients were randomized to either Epoetin alfa 40,000 IU or 1 ml sodium chloride 0.9 as subcutaneous injection within 24 h of TBI.
RESULTS
GFAP and S100B were measured in serum by ELISA from D0 (within 24 h of injury, prior to EPO/vehicle administration) to D5. Biomarker concentrations were compared between injury severities, diffuse vs. focal TBI, 6-month outcome scores (GOS-E) and EPO or placebo treatments. At D0 GFAP was significantly higher than S100B (951 pg/mL vs. 476 pg/mL, p = 0.018). ROC analysis of S100B at 1D post-injury distinguished favorable vs. unfavorable outcomes (area under the curve = 0.73; p = 0.01). EPO did not reduce concentration of either biomarker.
CONCLUSIONS
Elevated serum concentrations of GFAP and S100B after TBI reflect a robust, acute glial response to injury. Consistent with lack of improved outcome in TBI patients treated with EPO and prior findings on neuronal and axonal markers, glial biomarker concentrations and acute profiles were not affected by EPO.",2020,At D0 GFAP was significantly higher than S100B,['Forty-four patients with moderate-to-severe TBI were enrolled to a sub-study of the EPO-TBI trial'],"['S100B', 'EPO', 'EPO therapy', 'Epoetin alfa 40,000\xa0IU or 1\xa0ml sodium chloride', 'glial fibrillary acidic protein (GFAP']","['Biomarker concentrations', 'neuronal and axonal markers, glial biomarker concentrations and acute profiles']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0199970', 'cui_str': 'Erythropoietin therapy'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",44.0,0.140683,At D0 GFAP was significantly higher than S100B,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Hellewell', 'Affiliation': 'University of Sydney, Sydney, Australia; Department of Surgery, Alfred Hospital, Melbourne, Australia; Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia. Electronic address: sarah.hellewell@sydney.edu.au.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conquest', 'Affiliation': 'Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Little', 'Affiliation': 'Australian New Zealand Intensive Care Research Centre, Melbourne, Australia.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Vallance', 'Affiliation': 'Department of Intensive Care, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Board', 'Affiliation': 'Department of Intensive Care, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Department of Intensive Care Research, Austin Health, Melbourne, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cooper', 'Affiliation': 'Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Australian New Zealand Intensive Care Research Centre, Melbourne, Australia; Department of Intensive Care, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Morganti-Kossmann', 'Affiliation': 'Australian New Zealand Intensive Care Research Centre, Melbourne, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.04.081']
249,32329309,Baclofen-induced Changes in the Resting Brain Modulate Smoking Cue Reactivity: A Double-blind Placebo-controlled Functional Magnetic Resonance Imaging Study in Cigarette Smokers.,"Objective
Smoking cue-(SC) elicited craving can lead to relapse in SC-vulnerable individuals. Thus, identifying treatments that target SC-elicited craving is a top research priority. Reduced drug cue neural activity is associated with recovery and is marked by a profile of greater tonic (resting) activation in executive control regions, and increased connectivity between executive and salience regions. Evidence suggests the GABA-B agonist baclofen can reduce drug cue-elicited neural activity, potentially through its actions on the resting brain. Based on the literature, we hypothesize that baclofen's effects in the resting brain can predict its effects during SC exposure.
Methods
In this longitudinal, double blind, placebo-controlled neuropharmacological study 43 non-abstinent, sated treatment-seeking cigarette smokers (63% male) participated in an fMRI resting-state scan and a SC-reactivity task prior to (T1) and 3 weeks following randomization (T2; baclofen: 80 mg/day; n = 21). Subjective craving reports were acquired before and after SC exposure to explicitly examine SC-induced craving.
Results
Whole-brain full-factorial analysis revealed a group-by-time interaction with greater resting brain activation of the right dorsolateral prefrontal cortex (dlPFC) at T2 in the baclofen group (BAC) ( p FWEcorr = 0.02), which was associated with reduced neural responses to SCs in key cue-reactive brain regions; the anterior ventral insula and ventromedial prefrontal cortex ( p FWEcorr < 0.01). BAC, but not the placebo group reported decreased SC-elicited craving ( p = 0.02).
Conclusion
Results suggest that baclofen mitigates the reward response to SCs through an increase in tonic activation of the dlPFC, an executive control region. Through these mechanisms, baclofen may offer SC-vulnerable smokers protection from SC-induced relapse.",2020,"BAC, but not the placebo group reported decreased SC-elicited craving ( p = 0.02).
","['study 43 non-abstinent, sated treatment-seeking cigarette smokers (63% male) participated in an', 'Cigarette Smokers', 'SC-vulnerable individuals']","['fMRI resting-state scan and a SC-reactivity task prior to (T1', 'Placebo', 'placebo', 'placebo-controlled neuropharmacological']","['SC-elicited craving', 'Resting Brain Modulate Smoking Cue Reactivity', 'resting brain activation of the right dorsolateral prefrontal cortex (dlPFC', 'tonic activation', 'Subjective craving reports']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.126419,"BAC, but not the placebo group reported decreased SC-elicited craving ( p = 0.02).
","[{'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Ketcherside', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Kanchana', 'Initials': 'K', 'LastName': 'Jagannathan', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Sudipto', 'Initials': 'S', 'LastName': 'Dolui', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hager', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Spilka', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Chaela', 'Initials': 'C', 'LastName': 'Nutor', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Hengyi', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Franklin', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Reagan', 'Initials': 'R', 'LastName': 'Wetherill', 'Affiliation': 'The Center for Studies of Addiction, The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2020.18.2.289']
250,30926955,"Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial.","BACKGROUND
Some weight loss medications, including liraglutide 3.0 mg, are thought to facilitate weight loss by improving appetite control. However, no studies have evaluated their long-term appetitive effects.
SUBJECTS/METHODS
This study examined changes in appetite in a subsample of 113 adults with obesity (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m 2 ) who participated in a 52-week trial. Participants were randomized to intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0 mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). Participants rated their hunger, fullness after meals, liking of meals, and food preoccupation (all as experienced over the past week) using visual analogue scales (0-100 mm). Ratings were completed at baseline and eight subsequent visits over the year.
RESULTS
At week 52, participants treated by IBT-alone lost 6.2 ± 1.6% of baseline weight, compared with 11.8 ± 1.6% and 12.1 ± 1.5% in the IBT-liraglutide and Multi-component groups, respectively. Compared to IBT-alone, IBT-liraglutide participants reported larger reductions at week 6 in hunger (-0.3 ± 4.2 vs -16.8 ± 4.0 mm, p = .005) and food preoccupation (+0.2 ± 3.7 vs -16.3 ± 3.6 mm, p = .002) and larger increases in fullness (-5.1 ± 3.2 vs +9.8 ± 3.0 mm, p = .001). These significant differences persisted at all assessments through week 24. There were no differences between IBT-alone and IBT-liraglutide in meal liking. IBT-alone and Multi-component participants differed in hunger at week 6, and in food preoccupation at all assessments through week 24. Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively. There were no other differences among any groups at week 52.
CONCLUSIONS
Consistent with short-term studies, IBT-liraglutide participants reported greater improvements in hunger, fullness, and food preoccupation than those assigned to IBT-alone. Differences in appetite persisted for 24 weeks but were not maintained at week 52, despite the relatively greater weight losses in the liraglutide-treated participants at the trial's end.",2020,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","['113 adults with obesity (76.1% female, 55.8% white, BMI\u2009=\u200938.8\u2009±\u20094.8\u2009kg/m 2 ) who participated in a 52-week trial']","['intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0\u2009mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'IBT-alone, IBT-liraglutide', 'IBT-alone and Multi-component', 'IBT-liraglutide', 'liraglutide']","['hunger, fullness, and food preoccupation', 'liking of meals relative', 'hunger, fullness after meals, liking of meals, and food preoccupation', 'fullness', 'weight losses', 'food preoccupation', 'appetite', 'visual analogue scales', 'appetite, food preoccupation, and food liking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",113.0,0.0597185,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","[{'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Zayna M', 'Initials': 'ZM', 'LastName': 'Bakizada', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0348-6']
251,30919942,Risk of hospitalised bleeding in comparisons of oral anticoagulant options for the primary treatment of venous thromboembolism.,"Understanding of the comparative bleeding risks of oral anticoagulant (OAC) therapies for the primary treatment of venous thromboembolism (VTE) is limited. Therefore, among anticoagulant-naïve VTE patients, we conducted comparisons of apixaban, rivaroxaban and warfarin on the rate of hospitalised bleeding within 180 days of OAC initation. MarketScan databases for the time-period from 2011 to 2016 were used and, for each OAC comparison, new users were matched with up to five initiators of a different OAC. The final analysis included 83 985 VTE patients, who experienced 1944 hospitalised bleeding events. In multivariable-adjusted Cox regression models, rate of hospitalised bleeding was lower among new users of apixaban when compared to new users of rivaroxaban [hazard ratio (95% confidence interval) 0·58 (0·41-0·80)] or warfarin [0·68 (0·50-0·92)]. Overall, the hospitalised bleeding rate was similar when comparing new users of rivaroxaban to new users of warfarin [0·98 (0·68-1·11)], though there was some suggestion that rivaroxaban was associated with lower bleeding risk among younger individuals. Findings from this large real-world population concur with results from the randomised trial which found lower bleeding risk with apixaban versus warfarin and, for the first time, reveal a lower risk of bleeding in a comparison of apixaban versus rivaroxaban.",2019,"Overall, the hospitalised bleeding rate was similar when comparing new users of rivaroxaban to new users of warfarin [0·98 (0·68-1·11)], though there was some suggestion that rivaroxaban was associated with lower bleeding risk among younger individuals.","['within 180\xa0days of OAC initation', '83\xa0985 VTE patients, who experienced 1944 hospitalised bleeding events']","['apixaban, rivaroxaban and warfarin', 'oral anticoagulant (OAC) therapies', 'rivaroxaban', 'apixaban versus warfarin', 'warfarin']","['bleeding risk', 'hospitalised bleeding', 'hospitalised bleeding rate', 'rate of hospitalised bleeding']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",83985.0,0.0992347,"Overall, the hospitalised bleeding rate was similar when comparing new users of rivaroxaban to new users of warfarin [0·98 (0·68-1·11)], though there was some suggestion that rivaroxaban was associated with lower bleeding risk among younger individuals.","[{'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Lutsey', 'Affiliation': 'Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Zakai', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine & Department of Pathology and Laboratory Medicine, Larner College of Medicine at the University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'MacLehose', 'Affiliation': 'Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Faye L', 'Initials': 'FL', 'LastName': 'Norby', 'Affiliation': 'Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Rob F', 'Initials': 'RF', 'LastName': 'Walker', 'Affiliation': 'Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Roetker', 'Affiliation': 'Chronic Disease Research Group, Hennepin Healthcare Research Institute, Minneapolis, MN, USA.'}, {'ForeName': 'Terrence J', 'Initials': 'TJ', 'LastName': 'Adam', 'Affiliation': 'Department of Pharmaceutical Care and Health Systems, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}]",British journal of haematology,['10.1111/bjh.15857']
252,31144265,Breast cancer survivors reduce accelerometer-measured sedentary time in an exercise intervention.,"PURPOSE
Cancer survivors are highly sedentary and have low physical activity. How physical activity interventions impact sedentary behavior remains unclear. This secondary analysis examined changes in sedentary behavior among breast cancer survivors participating in a physical activity intervention that significantly increased moderate-to-vigorous physical activity (MVPA).
METHODS
Insufficiently active breast cancer survivors were randomized to a 12-week physical activity intervention (exercise arm) or control arm. The intervention focused solely on increasing MVPA with no content targeting sedentary behavior. Total sedentary behavior, light physical activity (LPA), and MVPA were measured at baseline and 12 weeks (ActiGraph GT3X+ accelerometer). Separate linear mixed-effects models tested intervention effects on sedentary behavior, intervention effects on LPA, the relationship between change in MVPA and change in sedentary behavior, and potential moderators of intervention effects on sedentary behavior.
RESULTS
The exercise arm had significantly greater reductions in sedentary behavior than the control arm (mean - 24.9 min/day (SD = 5.9) vs. - 4.8 min/day (SD = 5.9), b = - 20.1 (SE = 8.4), p = 0.02). Larger increases in MVPA were associated with larger decreases in sedentary behavior (b = - 1.9 (SE = 0.21), p < 0.001). Women farther out from surgery had significantly greater reductions in sedentary behavior than women closer to surgery (b = - 0.91 (SE = 0.5), p = 0.07). There was no significant group difference in change in LPA from baseline to 12 weeks (b = 5.64 (SE = 7.69), p = 0.48).
CONCLUSIONS
Breast cancer survivors in a physical activity intervention reduced total sedentary time in addition to increasing MVPA.
IMPLICATIONS FOR CANCER SURVIVORS
Both increasing physical activity and reducing sedentary behavior are needed to promote optimal health in cancer survivors. These results show that MVPA and sedentary behavior could be successfully targeted together, particularly among longer-term cancer survivors.
CLINICAL TRIAL REGISTRATION
This study is registered at www.ClinicalTrials.gov (NCT02332876).",2019,"The exercise arm had significantly greater reductions in sedentary behavior than the control arm (mean - 24.9 min/day (SD = 5.9) vs. - 4.8 min/day (SD = 5.9), b = - 20.1 (SE = 8.4), p = 0.02).","['breast cancer survivors participating in a', 'Insufficiently active breast cancer survivors', 'FOR CANCER SURVIVORS', 'Breast cancer survivors']","['physical activity intervention', 'exercise intervention', 'MVPA with no content targeting sedentary behavior', 'physical activity intervention (exercise arm) or control arm']","['total sedentary time', 'change in LPA', 'moderate-to-vigorous physical activity (MVPA', 'Total sedentary behavior, light physical activity (LPA), and MVPA', 'sedentary behavior', 'MVPA']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]",,0.0394997,"The exercise arm had significantly greater reductions in sedentary behavior than the control arm (mean - 24.9 min/day (SD = 5.9) vs. - 4.8 min/day (SD = 5.9), b = - 20.1 (SE = 8.4), p = 0.02).","[{'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Weiner', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Godbole', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Sandahl H', 'Initials': 'SH', 'LastName': 'Nelson', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Dorothy D', 'Initials': 'DD', 'LastName': 'Sears', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, San Diego, CA, USA. sjhartman@ucsd.edu.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00768-8']
253,32328709,"Correction to: A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.","The article A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor, was originally published Online First without Open Access.",2020,"The article A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor, was originally published Online First without Open Access.",[],"['drospirenone-only pill 4\xa0mg over nine cycles in comparison with desogestrel 0.075\xa0mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor', 'desogestrel 0.075\xa0mg', 'drospirenone']",[],[],"[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1306692', 'cui_str': 'Desogestrel 0.075 MG'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",[],,0.264965,"The article A multicenter, double-blind, randomized trial on the bleeding profle of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg, written by Santiago Palacios, Enrico Colli and Pedro-Antonio Regidor, was originally published Online First without Open Access.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Instituto Palacios, Salud Y Medicina de La Mujer, C/Antonio Acuña, 28009, Madrid, Spain.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, C/ Manuel Pombo Angulo 28, 4th Floor, 28050, Madrid, Spain.'}, {'ForeName': 'Pedro-Antonio', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Adalperostr. 84, 85737, Ismaning, Germany. pedro-antonio.regidor@exeltis.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05544-z']
254,30169797,"Evaluation of a Randomized Clinical Trial Comparing the Effectiveness of a Culturally Targeted and Nontargeted Smoking Cessation Intervention for Lesbian, Gay, Bisexual, and Transgender Smokers.","PURPOSE
To examine the benefits of a culturally targeted compared with a nontargeted smoking cessation intervention on smoking cessation outcomes among lesbian, gay, bisexual, and transgender (LGBT) smokers.
METHODS
A prospective randomized design was used to evaluate the added benefits of an LGBT culturally targeted Courage to Quit (CTQ-CT) smoking cessation treatment (N = 172) compared with the standard intervention (CTQ; N = 173). The smoking cessation program consisted of six treatment sessions combined with 8 weeks of nicotine replacement therapy. The primary smoking cessation outcome was 7-day point prevalence quit rates. Secondary outcomes examined included changes in nicotine dependence, nicotine withdrawal, cigarettes per day, smoking urges, self-efficacy, and readiness to quit.
RESULTS
Overall quit rates were 31.9% at 1 month, 21.1% at 3 months, 25.8% at 6 months, and 22.3% at 12 months. Quit rates did not differ between treatment groups [1 month OR = 0.81 (0.32, 2.09), 3 months OR = 0.65 (0.23, 1.78), 6 months OR = 0.45 (0.17, 1.21), 12 months OR = 0.70 (0.26, 1.91)]. Compared with baseline levels, all secondary smoking cessation outcomes measured were improved at 1 month and were maintained at 12-month follow-up. Compared with the CTQ, the CTQ-CT intervention was more highly rated on program effectiveness (d = 0.2, p = .011), intervention techniques (d = 0.2, p = .014), the treatment manual (d = 0.3, p < .001), and being targeted to the needs of LGBT smokers (d = 0.5, p < .0001).
CONCLUSIONS
LGBT smokers receiving the CTQ intervention achieved smoking cessation outcomes in the range reported for other demographic groups. Cultural targeting improved the acceptability of the intervention but did not confer any additional benefit for smoking cessation outcomes.
IMPLICATIONS
Study results have implications for understanding the benefits of culturally targeted compared with nontargeted smoking cessation interventions for improving smoking cessation outcomes among LGBT smokers. Shorter and longer term 7-day point prevalence quit rates associated with the targeted and nontargeted interventions were modest but comparable with other group-based interventions delivered in a community setting. Although cultural targeting improved the overall acceptability of the intervention, no added benefits were observed for the culturally targeted intervention on either the primary or secondary outcomes.",2019,Short and longer-term 7-day point prevalence quit rates associated with the targeted and non-targeted interventions were modest but comparable to other group based interventions delivered in a community setting.,"['lesbian, gay, bisexual and transgender (LGBT) smokers', 'LGBT smokers']","['nicotine replacement therapy', 'CTQ intervention', 'culturally targeted compared to a non-targeted smoking cessation intervention', 'CTQ-CT intervention', 'standard intervention (CTQ', 'LGBT culturally targeted Courage to Quit (CTQ-CT) smoking cessation treatment', 'culturally targeted and non-targeted smoking cessation intervention']","['7-day point prevalence quit rates', 'smoking cessation outcomes', 'Overall quit rates', 'secondary smoking cessation outcomes', 'program effectiveness', 'nicotine dependence, nicotine withdrawal, cigarettes per day, smoking urges, self-efficacy and readiness to quit', 'Quit rates', 'overall acceptability']","[{'cui': 'C1533642', 'cui_str': 'Women Who Have Sex With Women'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0870365', 'cui_str': 'Heroism'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0033334', 'cui_str': 'Program Effectiveness'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0236477,Short and longer-term 7-day point prevalence quit rates associated with the targeted and non-targeted interventions were modest but comparable to other group based interventions delivered in a community setting.,"[{'ForeName': 'Alicia K', 'Initials': 'AK', 'LastName': 'Matthews', 'Affiliation': 'Department of Health Systems Sciences, College of Nursing, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Alana D', 'Initials': 'AD', 'LastName': 'Steffen', 'Affiliation': 'Department of Health Systems Sciences, College of Nursing, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Raymond A', 'Initials': 'RA', 'LastName': 'Ruiz', 'Affiliation': 'College of Medicine, Center for Clinical and Translational Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Nat A', 'Initials': 'NA', 'LastName': 'Ross', 'Affiliation': 'Department of Research, Howard Brown Health Center, Chicago, IL.'}, {'ForeName': 'Larisa A', 'Initials': 'LA', 'LastName': 'Burke', 'Affiliation': 'Department of Health Systems Sciences, College of Nursing, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Chien Ching', 'Initials': 'CC', 'LastName': 'Li', 'Affiliation': 'Department of Health Services Research, Rush University, Chicago, IL.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty184']
255,32151146,Reducing HIV stigma among healthcare providers in India using a partly tablet-administered intervention: the DriSti trial.,"HIV stigma has long been recognized as a significant barrier in the worldwide fight against HIV. Across cultures, stigma has been shown to cause psychological distress and act as a barrier to engagement in care. Health professionals can serve as a crucial source of HIV stigma, with drivers that include fears and transmission misconceptions and pre-existing negative attitudes towards marginalized groups. To increase their impact, stigma reduction interventions need to be scalable and sustainable as well as adaptable to different cultural contexts. The DriSti intervention was designed to meet these needs through an easily adaptable, mostly tablet-administered, interactive intervention delivered to ward staff ( n = 1,557) and nursing students ( n = 1,625) in 62 Indian institutions, using a cRCT design, with wait-list controls. Six-month outcome analyses, showed significant reductions in misconceptions ( p < .001) and worry about acquiring HIV at work ( p < .001). Intervention participants also reported significantly greater reductions in endorsement of coercive policies ( p < .001) and in the number of situations in which they intended to discriminate against PLWH ( p < .001) than control participants. This brief, scaleable intervention could be adapted for similar populations in the region, using different mHealth platforms and thus has important implications for current global stigma reduction initiatives and training curricula.",2020,"Six-month outcome analyses, showed significant reductions in misconceptions ( p < .001) and worry about acquiring HIV at work ( p < .001).",[],[],"['HIV stigma', 'endorsement of coercive policies', 'misconceptions']",[],[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]",,0.0337234,"Six-month outcome analyses, showed significant reductions in misconceptions ( p < .001) and worry about acquiring HIV at work ( p < .001).","[{'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'Division of Prevention Sciences, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Raj', 'Affiliation': ""Division of Medical Informatics, St. John's Research Institute, Bangalore, India.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Heylen', 'Affiliation': 'Division of Prevention Sciences, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nyblade', 'Affiliation': 'Global Health Division, International Development Group, RTI International, USA.'}, {'ForeName': 'Dhinagaran', 'Initials': 'D', 'LastName': 'Devdass', 'Affiliation': ""Division of Medical Informatics, St. John's Research Institute, Bangalore, India.""}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': ""Division of Medical Informatics, St. John's Research Institute, Bangalore, India.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mazur', 'Affiliation': 'Division of Prevention Sciences, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health and Neurosciences, Department of Psychiatry, St. John's Research Institute, Bangalore, India.""}]",AIDS care,['10.1080/09540121.2020.1739221']
256,32293191,Mid-position treatment strategy for locally advanced lung cancer: a dosimetric study.,"OBJECTIVE
The internal target volume (ITV) strategy generates larger planning target volumes (PTVs) in locally advanced non-small cell lung cancer (LA-NSCLC) than the Mid-position (Mid-p) strategy. We investigated the benefit of the Mid-p strategy regarding PTV reduction and dose to the organs at risk (OARs).
METHODS
44 patients with LA-NSCLC were included in a randomized clinical study to compare ITV and Mid-p strategies. GTV were delineated by a physician on maximum intensity projection images and on Mid-p images from four-dimensional CTs. CTVs were obtained by adding 6 mm uniform margin for microscopic extension. CTV to PTV margins were calculated using the van Herk's recipe for setup and delineation errors. For the Mid-p strategy, the mean target motion amplitude was added as a random error. For both strategies, three-dimensional conformal plans delivering 60-66 Gy to PTV were performed. PTVs, dose-volume parameters for OARs (lung, esophagus, heart, spinal cord) were reported and compared.
RESULTS
With the Mid-p strategy, the median of volume reduction was 23.5 cm 3 ( p = 0.012) and 8.8 cm 3 ( p = 0.0083) for PTV T and PTV N respectively; the median mean lung dose reduction was 0.51 Gy ( p = 0.0057). For 37.1% of the patients, delineation errors led to smaller PTV with the ITV strategy than with the Mid-p strategy.
CONCLUSION
PTV and mean lung dose were significantly reduced using the Mid-p strategy. Delineation uncertainty can unfavorably impact the advantage.
ADVANCES IN KNOWLEDGE
To the best of our knowledge, this is the first dosimetric comparison study between ITV and Mid-p strategies for LA-NSCLC.",2020,"For 37.1% of the patients, delineation errors led to smaller PTV with the ITV strategy than with the Mid-p strategy.
","['44 patients with LA-NSCLC', 'locally advanced lung cancer']","['Mid-position treatment strategy', 'internal target volume (ITV) strategy generates larger planning target volumes (PTVs']","['mean target motion amplitude', 'median of volume reduction', 'PTVs, dose-volume parameters for OARs (lung, esophagus, heart, spinal cord']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}]",44.0,0.0337473,"For 37.1% of the patients, delineation errors led to smaller PTV with the ITV strategy than with the Mid-p strategy.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ayadi', 'Affiliation': 'Radiotherapy and Physics Department, Leon Berard Cancer Center, 28, rue Laennec F-69373, Lyon, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Baudier', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bouilhol', 'Affiliation': 'Department of Radiotherapy, Hartmann Radiotherapy Center, American Hospital of Paris, Neuilly, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dupuis', 'Affiliation': 'Radiotherapy and Physics Department, Leon Berard Cancer Center, 28, rue Laennec F-69373, Lyon, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Boissard', 'Affiliation': 'Radiotherapy and Physics Department, Leon Berard Cancer Center, 28, rue Laennec F-69373, Lyon, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pinho', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Krason', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rit', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Claude', 'Affiliation': 'Radiotherapy and Physics Department, Leon Berard Cancer Center, 28, rue Laennec F-69373, Lyon, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sarrut', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}]",The British journal of radiology,['10.1259/bjr.20190692']
257,29541464,Comparison of surgical outcomes and complications between the Harmonic FOCUS and conventional surgery for open thyroidectomy.,"The aim of the present study was to evaluate the potential advantages of the ultrasonic scalpel compared with the conventional technique in thyroid surgery. Patients with resectable thyroid cancer and Basedow's disease were assigned to ultrasonic scalpel or conventional technique (knot-tying and electrocoagulation). The present study used the Harmonic FOCUS ® (HF) as an ultrasonic scalpel. Between February 2013 and May 2016, 45 patients were enrolled into the study. Duration of the surgery was significantly decreased in the HF group compared with the conventional surgery (CS) group (median 142 vs. 151 min; P=0.0406). Intraoperative blood loss and total volume of drainage fluid were significantly decreased in the HF group compared with the CS group (median 40 vs. 125 ml; P=0.0054, and median 120 vs. 175.5 ml; P=0.0490). Duration of drain placement and length of hospitalization stay were similar in the two groups. Furthermore, the overall incidence of postoperative complications did not differ between the two groups. Overall, the present study suggests that open thyroidectomy using the HF is safe and effective and not associated with any increase in complications.",2018,"Intraoperative blood loss and total volume of drainage fluid were significantly decreased in the HF group compared with the CS group (median 40 vs. 125 ml; P=0.0054, and median 120 vs. 175.5 ml; P=0.0490).","['Between February 2013 and May 2016, 45 patients were enrolled into the study', ""Patients with resectable thyroid cancer and Basedow's disease""]","['Harmonic FOCUS ® (HF', 'ultrasonic scalpel or conventional technique (knot-tying and electrocoagulation', 'ultrasonic scalpel', 'conventional surgery (CS', 'Harmonic FOCUS and conventional surgery', 'conventional technique']","['overall incidence of postoperative complications', 'Intraoperative blood loss and total volume of drainage fluid', 'Duration of the surgery', 'complications', 'Duration of drain placement and length of hospitalization stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C0018213', 'cui_str': 'Graves Disease'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",45.0,0.0362551,"Intraoperative blood loss and total volume of drainage fluid were significantly decreased in the HF group compared with the CS group (median 40 vs. 125 ml; P=0.0054, and median 120 vs. 175.5 ml; P=0.0490).","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Namikawa', 'Affiliation': 'Department of Surgery, Kochi Medical School, Kochi 783-8505, Japan.'}, {'ForeName': 'Kazune', 'Initials': 'K', 'LastName': 'Fujisawa', 'Affiliation': 'Department of Surgery, Kochi Medical School, Kochi 783-8505, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Munekage', 'Affiliation': 'Department of Surgery, Kochi Medical School, Kochi 783-8505, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Munekage', 'Affiliation': 'Department of Surgery, Kochi Medical School, Kochi 783-8505, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Oki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kochi Medical School, Kochi 783-8505, Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Maeda', 'Affiliation': 'Cancer Treatment Center, Kochi Medical School Hospital, Kochi 783-8505, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Surgery, Kochi Medical School, Kochi 783-8505, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ueta', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kochi Prefectural Hata Kenmin Hospital, Kochi 783-8505, Japan.'}, {'ForeName': 'Michiya', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Cancer Treatment Center, Kochi Medical School Hospital, Kochi 783-8505, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hanazaki', 'Affiliation': 'Department of Surgery, Kochi Medical School, Kochi 783-8505, Japan.'}]",Molecular and clinical oncology,['10.3892/mco.2018.1567']
258,32187404,Modulation of experimental facial pain via somatosensory stimuli targeting sensations of different valence.,"BACKGROUND
Knowledge of pain modulation from oro-facial somatosensory stimuli with different valence (pleasant-unpleasant) is limited.
OBJECTIVES
To investigate (a) the modulatory effects of painful, pleasant and unpleasant somatosensory stimuli on two models of experimental facial pain, (b) whether modulation could be changed by blocking peripheral nerves via application of a local anaesthetic, EMLA, or blocking endogenous opioid receptors via naltrexone and (c) whether pain ratings were significantly correlated with participant psychological profiles.
METHODS
Thirty-eight healthy women received experimental facial skin burning pain or jaw myalgia for four randomised sessions on different days. The painful region was stimulated with mechanical or thermal painful, pleasant, unpleasant and control stimuli, with ratings recorded before and during stimulation. Sessions differed in pre-treatment: EMLA/naltrexone/placebo tablet/cream.
RESULTS
Significant effects of thermal or mechanical stimuli (P < .017), but not session (P > .102), were found on pain ratings for both models. In myalgia, painful cold resulted in a greater reduction in pain ratings than unpleasant cold, pleasant cold, control and pleasant warmth (P < .004). Decreases in pain ratings from painful, unpleasant and pleasant mechanical stimuli were greater than control (P < .002). In burning pain, painful cold resulted in a greater reduction in pain ratings than all but one of the other thermal stimuli (P < .033). The pleasant mechanical stimulus reduced pain ratings more than all other mechanical stimuli (P ≤ .003). There were no significant correlations between pain and psychometrics.
CONCLUSION
Valence-targeted thermal and mechanical stimuli modulated experimental myalgia and skin burning pain (P < .017). Partially blocking peripheral afferents or opioid receptors did not affect modulation.",2020,"Decreases in pain ratings from painful, unpleasant and pleasant mechanical stimuli was greater than control (P<0.002).",['38 healthy women received'],"['experimental facial skin burning pain or jaw myalgia', 'painful, pleasant and unpleasant somatosensory stimuli', 'EMLA/naltrexone/placebo tablet/cream']","['myalgia and skin burning pain', 'pain ratings from painful, unpleasant and pleasant mechanical stimuli', 'pain and psychometrics', 'pain ratings']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0234230', 'cui_str': 'Pain, Burning'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0234230', 'cui_str': 'Pain, Burning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}]",38.0,0.0493908,"Decreases in pain ratings from painful, unpleasant and pleasant mechanical stimuli was greater than control (P<0.002).","[{'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Taneja', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Olausson', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Trulsson', 'Affiliation': 'Scandinavian Centre for Orofacial Neurosciences (SCON), Aarhus, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Baad-Hansen', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}]",Journal of oral rehabilitation,['10.1111/joor.12963']
259,32192020,Impact of 12-Month Smartphone Breathing Meditation Program upon Systolic Blood Pressure among Non-Medicated Stage 1 Hypertensive Adults.,"(1) Background: Hypertension (HTN) affects ~50% of adults and is a major risk factor for stroke and cardiovascular disease. In 2017, the SPRINT trial outcomes led to lowering of HTN cutoffs by the American College of Cardiology (ACC) and American Heart Association (AHA). The Joint National Committee (JNC8) and National High BP Education Program recommend that lifestyle modifications be used as first-line HTN treatment. Chronic stress is a risk factor for HTN and cardiovascular disease. A recently completed 12 month randomized controlled trial (RCT) of a breathing meditation smart phone app (Tension Tamer, TT) involving JNC8 designated pre-HTN adults provided an opportunity to examine its impact upon individuals now classified as having stage 1 HTN. The TT app captures continuous real-time heart rate (HR) from a user's fingertip placed over a video camera lens during sessions. Users receive immediate feedback graphs after each session, showing their HR changes. They also receive motivational and social reinforcement SMS text messages the following day based upon levels of adherence. We conducted ancillary analyses of a 2-arm, 12-month, small-scale efficacy RCT among a subgroup of our total sample of participants, who are now classified as having stage 1 non-medicated systolic HTN. Primary outcome was change in resting systolic blood pressure (SBP). Secondary outcomes were change in resting diastolic blood pressure, adherence to the TT protocol, and perceived stress levels. (2) Methods: 30 adults (mean age: 45.0 years; 15 males; 16 White; 14 Black) with ACC/AHA 2017 defined systolic HTN (130-139 mmHg) on 3 consecutive sessions (mean SBP: 132.6 mmHg) were randomly assigned to TT or lifestyle education program delivered via smartphone (SPCTL). Each group received a twice-daily dosage schedule of TT or walking (month 1: 15 min; months 2 and 3: 10 min; months 4-12: 5 min). (3) Results: Mixed modeling results revealed a significant group x time effect for SBP (p<.01). The TT group showed greater SBP reductions at months 3 (-8.0 vs. -1.9), 6 (-10.0 vs. -0.7), and 12: (-11.6 vs. -0.4 mmHg; all p -values <0.04). (4) Conclusion: The TT app was beneficial in reducing SBP levels among adults with stage 1 systolic HTN. The TT app may be a promising, scalable first-line tactic for stage 1 HTN. Preparations are underway for an efficacy RCT involving uncontrolled stage 1 HTN patients.",2020,"The TT group showed greater SBP reductions at months 3 (-8.0 vs. -1.9), 6","['2) Methods: 30 adults (mean age: 45.0 years; 15 males; 16 White; 14 Black) with ACC/AHA 2017 defined systolic HTN (130-139 mmHg) on 3 consecutive sessions (mean SBP: 132.6 mmHg', 'Non', 'a subgroup of our total sample of participants, who are now classified as having stage 1 non-medicated systolic HTN', 'adults with stage 1 systolic HTN', 'Medicated Stage 1 Hypertensive Adults']","['breathing meditation smart phone app (Tension Tamer, TT) involving JNC8 designated pre-HTN adults', 'Smartphone Breathing Meditation Program', 'TT or lifestyle education program delivered via smartphone (SPCTL']","['SBP levels', 'lowering of HTN cutoffs by the American College of Cardiology (ACC) and American Heart Association (AHA', 'resting systolic blood pressure (SBP', 'Systolic Blood Pressure', 'SBP reductions', 'resting diastolic blood pressure, adherence to the TT protocol, and perceived stress levels']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0150277'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",,0.0940947,"The TT group showed greater SBP reductions at months 3 (-8.0 vs. -1.9), 6","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Sox', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Kinsey', 'Initials': 'K', 'LastName': 'Kellam', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Neely', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Nemeth', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Treiber', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17061955']
260,31424460,Temporary Stoppages and Burden of Treatment in Patients With Cancer.,"OBJECTIVES
To examine the effect of burden of treatment and multimorbidity on the relationship between baseline characteristics and oral oncolytic agent (OOA) temporary stoppages.
SAMPLE & SETTING
272 patients newly prescribed OOAs at six National Cancer Institute-designated comprehensive cancer centers.
METHODS & VARIABLES
Patients were randomly assigned to an adherence and symptom management group or a usual care/control group. Temporary OOA stoppages, symptom interference, OOA regimen complexity, and multimorbidities were explored. Data were collected at four-week intervals for 12 weeks.
RESULTS
Burden of treatment variables and multimorbidity had no significant effect on OOA temporary stoppages. Women and those prescribed kinase inhibitors were significantly more likely to experience a temporary stoppage.
IMPLICATIONS FOR NURSING
Oncology nurses are in a crucial position to educate patients on self-management of OOAs and symptoms. Nurses should be aware of patients who may be more susceptible to severe symptoms, including those with multimorbidities. Future research is needed to better understand OOA stoppages and factors associated with preventing stoppages.",2019,"RESULTS
Burden of treatment variables and multimorbidity had no significant effect on OOA temporary stoppages.","['AMP', '272 patients newly prescribed OOAs at six National Cancer Institute-designated comprehensive cancer centers', 'Patients With Cancer']",['adherence and symptom management group or a usual care/control group'],"['Temporary OOA stoppages, symptom interference, OOA regimen complexity, and multimorbidities']","[{'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",272.0,0.0547763,"RESULTS
Burden of treatment variables and multimorbidity had no significant effect on OOA temporary stoppages.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vachon', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Given', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Given', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'University of Illinois.'}]",Oncology nursing forum,['10.1188/19.ONF.E135-E144']
261,32328953,Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c ≤ 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials.,"INTRODUCTION
Clinical guidelines suggest a glycated hemoglobin A1c (HbA1c) target of ≤ 6.5% for type 2 diabetes patients with short duration of disease, few comorbidities and/or long life expectancy-provided this goal can be achieved safely. We explored whether initial combination treatment with the dipeptidyl peptidase-4 inhibitor linagliptin and metformin could provide better glycemic control (HbA1c ≤ 6.5%) than metformin alone without increasing hypoglycemia.
METHODS
We pooled and analyzed individual patient data from two randomized clinical trials of early combination therapy with linagliptin and metformin versus metformin monotherapy. The primary outcome in both trials was the change in HbA1c from baseline to week 24. We evaluated the percentage of patients who achieved HbA1c ≤ 6.5% at week 24 and the incidence of adverse events.
RESULTS
Most (> 70%) of the 1160 patients analyzed were treatment naive, and more than half had had diabetes for ≤ 1 year; mean baseline HbA1c was approximately 8.7%. Combination therapy with linagliptin and metformin resulted in more patients achieving HbA1c ≤ 6.5% than metformin alone, both for a metformin dose of 500 mg (40.1 vs. 22.9%, respectively, odds ratio [OR] 2.84, 95% confidence interval [CI] 1.87-4.32) and 1000 mg (49.5 vs. 35.4%, respectively, OR 2.28, 95% CI 1.54-3.40). Hypoglycemia occurred in < 3% of patients, with a comparable incidence between treatment groups. Other adverse events were also balanced between groups.
CONCLUSION
Early combination treatment with linagliptin and metformin can improve the chances of achieving tight glycemic control (HbA1c ≤ 6.5%) without increasing the risk of hypoglycemia or other adverse events.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT00798161 and NCT01708902.",2020,"Early combination treatment with linagliptin and metformin can improve the chances of achieving tight glycemic control (HbA1c ≤ 6.5%) without increasing the risk of hypoglycemia or other adverse events.
",['People with Type 2 Diabetes Improves Glycemic Control to HbA1c\u2009≤\u20096.5% without Increasing Hypoglycemia'],"['linagliptin and metformin', 'dipeptidyl peptidase-4 inhibitor linagliptin and metformin', 'linagliptin and metformin versus metformin monotherapy', 'Linagliptin and Metformin', 'metformin']","['Hypoglycemia', 'incidence of adverse events', 'chances of achieving tight glycemic control']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.174094,"Early combination treatment with linagliptin and metformin can improve the chances of achieving tight glycemic control (HbA1c ≤ 6.5%) without increasing the risk of hypoglycemia or other adverse events.
","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Endocrinology, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Miao', 'Affiliation': 'Lilly (Shanghai) Management Co. Ltd, Shanghai, China.'}, {'ForeName': 'Binqi', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, China.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Schepers', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Plat', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Endocrinology, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China. young.stone@163.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00819-9']
262,32324238,Azithromycin Treatment vs Placebo in Children With Respiratory Syncytial Virus-Induced Respiratory Failure: A Phase 2 Randomized Clinical Trial.,"Importance
Despite a high disease burden, there is no effective treatment for respiratory syncytial virus (RSV) infection.
Objectives
To determine whether administration of azithromycin (AZM) to children with RSV-induced respiratory failure is safe and to define the effect of AZM therapy on nasal matrix metalloproteinase 9 (MMP-9) levels.
Design, Setting, and Participants
This randomized, double-blind, placebo-controlled phase 2 trial was conducted at a single tertiary pediatric intensive care unit from February 2016 to February 2019. The study included children with RSV infection who were admitted to the pediatric intensive care unit and required respiratory support via positive pressure ventilation (invasive and noninvasive). A total of 147 children were screened; 90 were excluded for not meeting inclusion criteria, having an absent legal guardian, lacking pharmacy support, or having a language barrier and 9 declined participation, resulting in 48 patients enrolled in the study.
Intervention
Receipt of standard dose AZM (10 mg/kg/d), high-dose AZM (20 mg/kg/d), or a matching placebo of normal saline intravenously for 3 days.
Main Outcomes and Measures
Nasal and endotracheal samples were collected at baseline as well as at 24 hours and 48 hours after start of treatment. The secondary outcome was to determine treatment effect on clinical outcome measures, including days of positive pressure ventilation and length of hospital stay.
Results
A total of 48 patients were enrolled in the trial, with a median (range) age at randomization of 12 (1 to 125) months; 36 participants (75.0%) were younger than 2 years. Overall, 26 participants (54.2%) were boys, and 29 (60.4%) had a comorbidity. A total of 16 patients were randomized into each trial group (ie, placebo, standard-dose AZM, and high-dose AZM). Baseline demographic characteristics were comparable among the 3 groups. Both doses of AZM were safe, with no adverse events observed. No difference in nasal MMP-9 levels were observed between treatment groups. Among those who required mechanical ventilation and received high-dose AZM, endotracheal active and total MMP-9 levels were lower on day 3. Compared with baseline, active and total MMP-9 levels in endotracheal aspirates were 1.0 log lower in the high-dose AZM group (active MMP-9: 99.8% CI, -1.28 to -0.64; P < .001; total MMP-9: 99.8% CI, -1.37 to -0.57; P < .001). Patients who received high-dose AZM had fewer median (interquartile range) hospital days compared with those receiving the placebo (8 [6-14] days vs 11 [8-20] days; mean ratio estimate, 0.57; 95% CI, 0.38-0.87; P = .01).
Conclusions and Relevance
In this phase 2 randomized clinical trial, both doses of AZM were safe. While nasal MMP-9 levels were unchanged among treatment groups, endotracheal MMP-9 levels were lower among those who received high-dose AZM. The positive secondary clinical outcome, while exploratory, provides insight for end points in a multicenter randomized trial.
Trial Registration
ClinicalTrials.gov Identifier: NCT02707523.",2020,"While nasal MMP-9 levels were unchanged among treatment groups, endotracheal MMP-9 levels were lower among those who received high-dose AZM.","['single tertiary pediatric intensive care unit from February 2016 to February 2019', 'children with RSV-induced respiratory failure', 'children with RSV infection who were admitted to the pediatric intensive care unit and required respiratory support via positive pressure ventilation (invasive and noninvasive', '16 patients', 'A total of 147 children were screened; 90 were excluded for not meeting inclusion criteria, having an absent legal guardian, lacking pharmacy support, or having a language barrier and 9 declined participation, resulting in 48 patients enrolled in the study', 'Children With Respiratory Syncytial Virus-Induced Respiratory Failure', '48 patients were enrolled in the trial, with a median (range) age at randomization of 12 (1 to 125) months; 36 participants (75.0%) were younger than 2 years', '26 participants (54.2%) were boys, and 29 (60.4%) had a comorbidity']","['placebo of normal saline intravenously for 3 days', 'AZM therapy', 'azithromycin (AZM', 'standard dose AZM', 'placebo, standard-dose AZM, and high-dose AZM', 'high-dose AZM', 'placebo', 'Azithromycin Treatment vs Placebo', 'AZM']","['endotracheal MMP-9 levels', 'active and total MMP-9 levels', 'days of positive pressure ventilation and length of hospital stay', 'Measures\n\n\nNasal and endotracheal samples', 'endotracheal active and total MMP-9 levels', 'Baseline demographic characteristics', 'nasal MMP-9 levels']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0035235', 'cui_str': 'Respiratory syncytial virus infection'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0237167', 'cui_str': 'Language barrier'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",147.0,0.764452,"While nasal MMP-9 levels were unchanged among treatment groups, endotracheal MMP-9 levels were lower among those who received high-dose AZM.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Kong', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Wei Wei', 'Initials': 'WW', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sewell', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gorman', 'Affiliation': 'McWhorter School of Pharmacy, Samford University, Birmingham, Alabama.'}, {'ForeName': 'Hui-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Aban', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Whitley', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.3482']
263,32311627,Women's experience of induction of labor using PGE2 as an inpatient versus balloon catheter as an outpatient.,"OBJECTIVE
Induction of labor (IOL) typically involves cervical priming in an inpatient setting. Outpatient cervical priming may be a safe and cost-effective alternative. However, little is known about women's preference and the impact of outpatient cervical priming on their healthcare experience. The objective was to compare women's healthcare experiences following IOL using a balloon catheter and going home, versus prostaglandin (PG) and remaining an inpatient.
STUDY DESIGN
A randomized controlled trial was undertaken across eight Australian maternity hospitals. Between September 2015 and October 2018, 695 women with uncomplicated term singleton pregnancies were randomized. Of these, 215 and 233 women in the balloon-outpatient and PG-inpatient groups, respectively, received the allocated intervention. The PG group received Dinoprostone gel or controlled-release tape. The balloon group had a double-balloon catheter inserted and went home. Experiential and quality-of-life outcomes were measured via written questionnaire after birth. The primary outcome was a composite neonatal measure. Women's healthcare experience, health-state (EQ-5D-3 L) and pain scores are reported here.
RESULTS
Questionnaire data were available for 366 (81.7 %) women enrolled who received their treatment allocation. More women in the balloon-outpatient group reported they would choose IOL next pregnancy (49.2 % vs 38.4 %; p = 0.037) and desire the same method (72.4 % vs 61.1 %; p = 0.022). The balloon-outpatient group experienced higher pain scores at the start of IOL (median (IQR) 3(2-5) vs 2(1-4); p = 0.002) but lower scores at time of rupture of membranes (3(1-5) vs 4(2-6); p = 0.007). The EQ-5D-3 L health-utility index did not differ significantly between the groups (0.77 vs 0.78; p = 0.899).
CONCLUSIONS
Women report similar healthcare experiences following balloon-outpatient compared to PG-impatient IOL, but are more likely to desire the same method next pregnancy if IOL is required. If both options are available, then differences in experience should be shared with women, alongside differences in clinical outcomes as part of their decision-making process.",2020,"The EQ-5D-3 L health-utility index did not differ significantly between the groups (0.77 vs 0.78; p = 0.899).
","['215 and 233 women in the balloon-outpatient and PG-inpatient groups', 'Questionnaire data were available for 366 (81.7 %) women enrolled who received their treatment allocation', 'Between September 2015 and October 2018, 695 women with uncomplicated term singleton pregnancies', 'eight Australian maternity hospitals']","['double-balloon catheter inserted and went home', 'IOL using a balloon catheter and going home, versus prostaglandin (PG) and remaining an inpatient', 'Dinoprostone gel or controlled-release tape']","['EQ-5D-3 L health-utility index', 'IOL next pregnancy', ""Women's healthcare experience, health-state (EQ-5D-3 L) and pain scores"", 'Experiential and quality-of-life outcomes', 'composite neonatal measure', 'pain scores']","[{'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",695.0,0.164063,"The EQ-5D-3 L health-utility index did not differ significantly between the groups (0.77 vs 0.78; p = 0.899).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': 'Mater Health, Queensland, Australia; University of Queensland, School of Medicine, Queensland, Australia; Mater Research, The University of Queensland, Queensland, Australia. Electronic address: Michael.Beckmann@mater.org.au.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Acreman', 'Affiliation': 'Mater Health, Queensland, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Schmidt', 'Affiliation': 'Mater Health, Queensland, Australia.'}, {'ForeName': 'Katharina M D', 'Initials': 'KMD', 'LastName': 'Merollini', 'Affiliation': 'University of the Sunshine Coast, School of Health and Sport Sciences, Queensland, Australia.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Miller', 'Affiliation': 'Queensland University of Technology, Queensland, Australia.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.03.031']
264,31867650,Effects of 6-Week Use of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.,"INTRODUCTION
The US Food and Drug Administration is considering implementing a reduced-nicotine standard for cigarettes. Given the high rate of smoking among people with serious mental illness (SMI), it is important to examine the responses of these smokers to very low nicotine content (VLNC) cigarettes.
METHODS
This trial compared the effects of VLNC (0.4 mg nicotine/g tobacco) and normal nicotine content cigarettes (15.8 mg/g) over a 6-week period in non-treatment-seeking smokers with schizophrenia, schizoaffective disorder, or bipolar disorder (n = 58). Linear regression was used to examine the effects of cigarette condition on cigarettes per day, subjective responses, nicotine and tobacco toxicant exposure, craving, withdrawal symptoms, and psychiatric symptoms.
RESULTS
At week 6, participants in the VLNC condition smoked fewer cigarettes per day, had lower breath carbon monoxide levels, lower craving scores, and rated their study cigarettes lower in satisfaction, reward, enjoyment, and craving reduction than those in the normal nicotine content condition (ps < .05). Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05). There were no differences across conditions on total nicotine exposure, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, withdrawal symptoms, or responses to abstinence.
CONCLUSIONS
These results suggest that a reduced-nicotine standard for cigarettes would reduce smoking among smokers with SMI. However, the lack of effect on total nicotine exposure indicates VLNC noncompliance, suggesting that smokers with SMI may respond to a reduced-nicotine standard by substituting alternative forms of nicotine.
IMPLICATIONS
Results from this trial suggest that a reduced-nicotine standard for cigarettes would reduce smoking rates and smoke exposure in smokers with SMI, without increasing psychiatric symptoms. However, noncompliance with VLNC cigarettes was observed, suggesting that these smokers might respond to a reduced-nicotine standard by substituting alternative forms of nicotine.",2019,"Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05).","['Smokers With Serious Mental Illness', 'people with serious mental illness (SMI', 'smokers with SMI', 'non-treatment-seeking smokers with schizophrenia, schizoaffective disorder, or bipolar disorder (n = 58']","['Very Low Nicotine Content Cigarettes', 'nicotine/g tobacco) and normal nicotine content cigarettes', 'VLNC']","['smoking rates and smoke exposure', 'total nicotine exposure, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, withdrawal symptoms, or responses to abstinence', 'lower breath carbon monoxide levels, lower craving scores, and rated their study cigarettes lower in satisfaction, reward, enjoyment, and craving reduction', 'cigarettes per day, subjective responses, nicotine and tobacco toxicant exposure, craving, withdrawal symptoms, and psychiatric symptoms', 'extrapyramidal symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign (finding)'}]",,0.0162502,"Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05).","[{'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Cassidy', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Swift', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rubin', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz133']
265,31017637,"Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial.","Importance
Whether anticoagulation benefits patients with heart failure (HF) in sinus rhythm is uncertain. The COMMANDER HF randomized clinical trial evaluated the effects of adding low-dose rivaroxaban to antiplatelet therapy in patients with recent worsening of chronic HF with reduced ejection fraction, coronary artery disease (CAD), and sinus rhythm. Although the primary end point of all-cause mortality, myocardial infarction, or stroke did not differ between rivaroxaban and placebo, there were numerical advantages favoring rivaroxaban for myocardial infarction and stroke.
Objective
To examine whether low-dose rivaroxaban was associated with reduced thromboembolic events in patients enrolled in the COMMANDER HF trial.
Design, Setting, and Participants
Post hoc analysis of the COMMANDER HF multicenter, randomized, double-blind, placebo-controlled trial in patients with CAD and worsening HF. The trial randomized 5022 patients postdischarge from a hospital or outpatient clinic after treatment for worsening HF between September 2013 and October 2017. Patients were required to be receiving standard care for HF and CAD and were excluded for a medical condition requiring anticoagulation or a bleeding history. Patients were randomized in a 1:1 ratio. Analysis was conducted from June 2018 and January 2019.
Intervention
Patients were randomly assigned to receive 2.5 mg of rivaroxaban given orally twice daily or placebo in addition to their standard therapy.
Main Outcomes and Measures
For this post hoc analysis, a thromboembolic composite was defined as either (1) myocardial infarction, ischemic stroke, sudden/unwitnessed death, symptomatic pulmonary embolism, or symptomatic deep venous thrombosis or (2) all of the previous components except sudden/unwitnessed deaths because not all of these are caused by thromboembolic events.
Results
Of 5022 patients, 3872 (77.1%) were men, and the overall mean (SD) age was 66.4 (10.2) years. Over a median (interquartile range) follow-up of 19.6 (11.7-30.8) months, fewer patients assigned to rivaroxaban compared with placebo had a thromboembolic event including sudden/unwitnessed deaths: 328 (13.1%) vs 390 (15.5%) (hazard ratio, 0.83; 95% CI, 0.72-0.96; P = .01). When sudden/unwitnessed deaths were excluded, the results analyzing thromboembolic events were similar: 153 (6.1%) vs 190 patients (7.6%) with an event (hazard ratio, 0.80; 95% CI, 0.64-0.98; P = .04).
Conclusions and Relevance
In this study, thromboembolic events occurred frequently in patients with HF, CAD, and sinus rhythm. Rivaroxaban may reduce the risk of thromboembolic events in this population, but these events are not the major cause of morbidity and mortality in patients with recent worsening of HF for which rivaroxaban had no effect. While consistent with other studies, these results require confirmation in prospective randomized clinical trials.
Trial Registration
ClinicalTrials.gov identifier: NCT01877915.",2019,"Although the primary end point of all-cause mortality, myocardial infarction, or stroke did not differ between rivaroxaban and placebo, there were numerical advantages favoring rivaroxaban for myocardial infarction and stroke.
","['patients with recent worsening of chronic HF with reduced ejection fraction, coronary artery disease (CAD), and sinus rhythm', 'patients with heart failure (HF', '5022 patients postdischarge from a hospital or outpatient clinic after treatment for worsening HF between September 2013 and October 2017', '5022 patients, 3872 (77.1%) were men, and the overall mean (SD) age was 66.4 (10.2) years', 'Patients were required to be receiving standard care for HF and CAD and were excluded for a medical condition requiring anticoagulation or a bleeding history', 'Patients With Heart Failure, Coronary Disease, and Sinus Rhythm', 'patients with CAD and worsening HF', 'patients enrolled in the COMMANDER HF trial']","['rivaroxaban given orally twice daily or placebo', 'rivaroxaban', 'placebo', 'Rivaroxaban']","['thromboembolic composite was defined as either (1) myocardial infarction, ischemic stroke, sudden/unwitnessed death, symptomatic pulmonary embolism, or symptomatic deep venous thrombosis or (2) all of the previous components except sudden/unwitnessed deaths', 'thromboembolic event including sudden/unwitnessed deaths', 'risk of thromboembolic events', 'thromboembolic events', 'myocardial infarction and stroke', 'cause mortality, myocardial infarction, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C4521843', 'cui_str': 'CDR'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1276802', 'cui_str': 'Sudden onset'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",5022.0,0.382181,"Although the primary end point of all-cause mortality, myocardial infarction, or stroke did not differ between rivaroxaban and placebo, there were numerical advantages favoring rivaroxaban for myocardial infarction and stroke.
","[{'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'Cardiology Division, Department of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies, Berlin, Germany.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Byra', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Hsiaowei', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'Janssen Research and Development, Spring House, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'La Police', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Nessel', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Research and Development, Pharmaceuticals, Thrombosis and Hematology Therapeutic Area, Bayer US, Whippany, New Jersey.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Vanden Boom', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Universite de Lorraine, INSERM Unite 1116, Vandoeuvre les Nancy, France.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1049']
266,30628813,Naltrexone and alcohol effects on craving for cigarettes in heavy drinking smokers.,"Naltrexone has been extensively studied for the treatment of alcohol use disorder. However, less is known about the effects of naltrexone on smoking outcomes in the context of alcohol use among East Asian individuals who have been suggested to differ in response to alcohol and to naltrexone. The present study is a secondary analysis that used a double-blind placebo-controlled design (n = 31) to examine the (a) effects of alcohol on basal craving for cigarettes, (b) effects of naltrexone on cigarette craving and alcohol craving during alcohol administration, and (c) relationship between craving for alcohol and cigarettes. Heavy drinking smokers of East Asian descent completed two counterbalanced intravenous alcohol administration sessions, one after taking naltrexone (50 mg) for five days and one after taking a placebo for five days. Self-reported subjective craving for cigarettes and for alcohol was recorded during each experimental session. Craving for cigarettes and alcohol increased significantly throughout the intravenous alcohol administration. A significant breath alcohol concentration (BrAC) × Medication interaction revealed that naltrexone blunted cigarette craving during alcohol administration, compared to placebo. Naltrexone significantly reduced craving for alcohol during alcohol administration in this group of heavy drinking smokers. Alcohol craving significantly predicted cigarette craving, however this effect did not vary across rising alcohol administration or by medication. These findings demonstrate that naltrexone reduces the urge to smoke and to drink during alcohol administration. Clinical studies are needed to further ascertain whether naltrexone may be of benefit to this distinct subgroup of heavy drinking smokers. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,Naltrexone significantly reduced craving for alcohol during alcohol administration in this group of heavy drinking smokers.,"['heavy drinking smokers', 'Heavy drinking smokers of East Asian descent', 'East Asian individuals who have been suggested to differ in response to alcohol and to']","['alcohol', 'naltrexone', 'Naltrexone', 'placebo']","['breath alcohol concentration (BrAC', 'cigarette craving and alcohol craving', 'cigarette craving', 'Craving for cigarettes and alcohol', 'craving for alcohol']","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",,0.0141006,Naltrexone significantly reduced craving for alcohol during alcohol administration in this group of heavy drinking smokers.,"[{'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Bujarski', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000252']
267,32203675,Comparison of Tendon Lengthening With Traditional Versus Accelerated Rehabilitation After Achilles Tendon Repair: A Prospective Randomized Controlled Trial.,"BACKGROUND
Early weightbearing protocols after Achilles tendon repair promote mobilization, yet little is known about their effect on tendon lengthening.
PURPOSE
To evaluate tendon lengthening after Achilles tendon repair with accelerated rehabilitation.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 1.
METHODS
Patients undergoing primary repair for acute Achilles tendon ruptures consented to have tantalum beads placed within the tendon. Patients were randomized into either a traditional (weightbearing at 6 weeks) or accelerated (graduated weightbearing at 2 weeks) rehabilitation group. The primary outcome of the study was postoperative tendon elongation as measured by radiostereometric beads. Secondary outcomes included Achilles Tendon Total Rupture Score (ATRS) and Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (PROMIS PI-SF) score.
RESULTS
All 18 patients included in the final analysis were found to have significant tendon lengthening after surgery, with a mean lengthening of 15.9 mm. No significant differences were found in overall lengthening between the traditional and accelerated rehabilitation groups (15.3 ± 4.5 vs 16.4 ± 4.7 mm, respectively; P = .33) at final follow-up. The repair site in each group was found to lengthen more than the intratendinous site (traditional group, 13.2 vs 2.1 mm; accelerated group, 16.8 vs -0.4 mm); however, no difference in lengthening was seen between groups ( P = .82 and P = .31, respectively). The greatest amount of lengthening occurred between 2 and 6 weeks, and the least amount of lengthening occurred between 6 and 12 weeks, with no difference between the traditional and accelerated groups at these time points ( P = .84 and P = .38, respectively). No differences were noted in ankle range of motion (dorsiflexion, P = .16; plantarflexion, P = .08) or outcome scores (ATRS, P = .56; PROMIS PI-SF, P = .54).
CONCLUSION
This study's findings demonstrate that all patients undergoing operative repair of Achilles tendon ruptures had lengthening after surgery. No difference was found in tendon lengthening (repair site or intratendinous) at any time point between patients undergoing traditional versus accelerated rehabilitation postoperatively. The greatest amount of lengthening was found to occur between 2 and 6 weeks postoperatively, and tendon lengthening decreased significantly after 6 weeks.
REGISTRATION
NCT04050748 (ClinicalTrials.gov identifier).",2020,"No differences were noted in ankle range of motion (dorsiflexion, P = .16; plantarflexion, P = .08) or outcome scores (ATRS, P = .56; PROMIS PI-SF, P = .54).
","['Patients undergoing primary repair for acute Achilles tendon ruptures consented to have tantalum beads placed within the tendon', 'patients undergoing operative repair of Achilles tendon ruptures had lengthening after surgery', 'After Achilles Tendon Repair']","['Lengthening With Traditional Versus Accelerated Rehabilitation', 'traditional (weightbearing at 6 weeks) or accelerated (graduated weightbearing at 2 weeks) rehabilitation group', 'tendon lengthening after Achilles tendon repair with accelerated rehabilitation', 'Tendon']","['ankle range of motion (dorsiflexion', 'tendon lengthening (repair site or intratendinous', 'greatest amount of lengthening', 'least amount of lengthening', 'Achilles Tendon Total Rupture Score (ATRS) and Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (PROMIS PI-SF) score', 'overall lengthening', 'postoperative tendon elongation', 'tendon lengthening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0263970', 'cui_str': 'Rupture of Achilles tendon'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0039297', 'cui_str': 'Tantalum'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0407029', 'cui_str': 'Repair of tendo achilles (procedure)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0565350', 'cui_str': 'Repair of tendon (procedure)'}]","[{'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1318107', 'cui_str': 'Loadbearing'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0407029', 'cui_str': 'Repair of tendo achilles (procedure)'}]","[{'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C0441593', 'cui_str': 'Tendon Lengthening'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}]",18.0,0.140827,"No differences were noted in ankle range of motion (dorsiflexion, P = .16; plantarflexion, P = .08) or outcome scores (ATRS, P = .56; PROMIS PI-SF, P = .54).
","[{'ForeName': 'Kelechi R', 'Initials': 'KR', 'LastName': 'Okoroha', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Najib', 'Initials': 'N', 'LastName': 'Ussef', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Toufic R', 'Initials': 'TR', 'LastName': 'Jildeh', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Lafi S', 'Initials': 'LS', 'LastName': 'Khalil', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Laith', 'Initials': 'L', 'LastName': 'Hasan', 'Affiliation': 'Tulane University Medical School, New Orleans, Louisiana, USA.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Bench', 'Affiliation': 'Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Ferras', 'Initials': 'F', 'LastName': 'Zeni', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Eller', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Moutzouros', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}]",The American journal of sports medicine,['10.1177/0363546520909389']
268,32320639,Prevalence of Pre-Existing Hearing Loss Among Patients With Drug-Resistant Tuberculosis in South Africa.,"Purpose Hearing loss, resulting from aminoglycoside ototoxicity, is common among patients with drug-resistant tuberculosis (DR-TB). Those with pre-existing hearing loss are at particular risk of clinically important hearing loss with aminoglycoside-containing treatment than those with normal hearing at baseline. This study aimed to identify factors associated with pre-existing hearing loss among patients being treated for DR-TB in South Africa. Method Cross-sectional analysis nested within a cluster-randomized trial data across 10 South African TB hospitals. Patients ≥ 13 years old received clinical and audiological evaluations before DR-TB treatment initiation. Results Of 936 patients, average age was 35 years. One hundred forty-two (15%) reported pre-existing auditory symptoms. Of 482 patients tested by audiometry, 290 (60%) had pre-existing hearing loss. The prevalence of pre-existing hearing loss was highest among patients ≥ 50 years (adjusted prevalence ratio [aPrR] for symptoms 5.53, 95% confidence interval (CI) [3.63, 8.42]; aPrR for audiometric hearing loss 1.63, 95% CI [1.31, 2.03] compared to age 13-18 years) and among those with a prior history of second-line TB treatment (aPrR for symptoms 1.73, 95% CI [1.66, 1.80]; PrR for audiometric hearing loss 1.33, 95% CI [1.03, 1.73]). Having HIV with cluster of differentiation 4 cell count < 200 cells/mm 3 and malnutrition were risk factors but did not reach statistical significance in adjusted analyses. Conclusion Pre-existing hearing loss is common among patients presenting for DR-TB treatment in South Africa, and those older than the age of 50 years or who had prior second-line TB treatment history were at highest risk.",2020,"The prevalence of pre-existing hearing loss was highest among patients ≥ 50 years (adjusted prevalence ratio [aPrR] for symptoms 5.53, 95% confidence interval (CI) [3.63, 8.42]; aPrR for audiometric hearing loss 1.63, 95% CI [1.31, 2.03] compared to age 13-18 years) and among those with a prior history of second-line TB treatment (aPrR for symptoms 1.73, 95% CI [1.66, 1.80]; PrR for audiometric hearing loss 1.33, 95% CI [1.03, 1.73]).","['patients presenting for DR-TB treatment in South Africa, and those older than the age of 50 years or who had prior second-line TB treatment history were at highest risk', 'Patients With Drug-Resistant Tuberculosis in South Africa', '482 patients tested by audiometry, 290 (60%) had pre-existing hearing loss', 'Patients ≥ 13 years old received clinical and audiological evaluations before DR-TB treatment initiation', 'patients being treated for DR-TB in South Africa', '936 patients', '10 South African TB hospitals', 'patients with drug-resistant tuberculosis (DR-TB']",['Pre-Existing Hearing Loss'],"['prevalence of pre-existing hearing loss', 'audiometric hearing loss', 'pre-existing auditory symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206525', 'cui_str': 'Drug resistant tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004286', 'cui_str': 'Audiometric test'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0200297', 'cui_str': 'Audiological evaluation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",936.0,0.114216,"The prevalence of pre-existing hearing loss was highest among patients ≥ 50 years (adjusted prevalence ratio [aPrR] for symptoms 5.53, 95% confidence interval (CI) [3.63, 8.42]; aPrR for audiometric hearing loss 1.63, 95% CI [1.31, 2.03] compared to age 13-18 years) and among those with a prior history of second-line TB treatment (aPrR for symptoms 1.73, 95% CI [1.66, 1.80]; PrR for audiometric hearing loss 1.33, 95% CI [1.03, 1.73]).","[{'ForeName': 'Hyejeong', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Departments of Epidemiology and International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Divisions of Clinical Pharmacology and Infectious Disease, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Francis', 'Affiliation': 'Division of Head and Neck Surgery and Communication Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Chakra', 'Initials': 'C', 'LastName': 'Budhathoki', 'Affiliation': 'The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'Hae-Ra', 'Initials': 'HR', 'LastName': 'Han', 'Affiliation': 'The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Farley', 'Affiliation': 'The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}]",American journal of audiology,['10.1044/2020_AJA-19-00103']
269,32319313,Animal-Assisted Activity in Critically Ill Older Adults: A Randomized Pilot and Feasibility Trial.,"BACKGROUND
Limited evidence suggests the efficacy of animal-assisted activities (AAA) in improving biobehavioral stress responses in older patients in intensive care units (ICUs).
OBJECTIVES
To assess the feasibility of an AAA (dog) intervention for improving biobehavioral stress response, measured by self-reported stress and anxiety and salivary cortisol, C-reactive protein, and interleukin-1β in older ICU patients, we examined enrollment, attrition, completion, data collection, and biobehavioral stress responses.
METHODS
ICU patients ≥60 years old were randomly assigned to a 10-min AAA intervention or control/usual ICU care. Attitudes toward pets were assessed before the intervention. Self-reported stress and anxiety and salivary stress biomarkers were collected before and after the intervention and the usual care condition.
RESULTS
The majority of patients were ineligible due to lack of decisional capacity, younger age, inability to provide saliva specimens, or critical illness. Though 15 participants were randomly allocated (AAA = 9; control = 6), only 10 completed the study. All participants completed the questionnaires; however, saliva specimens were significantly limited by volume. AAA was associated with decreases in stress and anxiety. Biomarker results were variable and revealed no specific trends associated with stress responses. Conclusions : Barriers to recruitment included an insufficient number of patients eligible for AAA based on hospital policy, difficulty finding patients who met study eligibility criteria, and illness-related factors. Recommendations for future studies include larger samples, a stronger control intervention such as a visitor without a dog, greater control over the AAA intervention, and use of blood from indwelling catheters for biomarkers.",2020,"METHODS
ICU patients ≥60 years old were randomly assigned to a 10-min AAA intervention or control/usual ICU care.","['older ICU patients', 'older patients in intensive care units (ICUs', 'Critically Ill Older Adults', '15 participants were randomly allocated (AAA = 9; control = 6), only 10 completed the study', 'ICU patients ≥60 years old']","['10-min AAA intervention or control/usual ICU care', 'AAA (dog) intervention', 'animal-assisted activities (AAA', 'AAA']","['biobehavioral stress responses', 'stress and anxiety', 'biobehavioral stress response, measured by self-reported stress and anxiety and salivary cortisol, C-reactive protein, and interleukin-1β', 'Self-reported stress and anxiety and salivary stress biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",15.0,0.0547544,"METHODS
ICU patients ≥60 years old were randomly assigned to a 10-min AAA intervention or control/usual ICU care.","[{'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Branson', 'Affiliation': 'Cizik School of Nursing, The University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Boss', 'Affiliation': 'Cizik School of Nursing, The University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Shannan', 'Initials': 'S', 'LastName': 'Hamlin', 'Affiliation': 'Houston Methodist Hospital, TX, USA.'}, {'ForeName': 'Nikhil S', 'Initials': 'NS', 'LastName': 'Padhye', 'Affiliation': 'Cizik School of Nursing, The University of Texas Health Science Center at Houston, TX, USA.'}]",Biological research for nursing,['10.1177/1099800420920719']
270,32071052,Early Bactericidal Activity Trial of Nitazoxanide for Pulmonary Tuberculosis.,"This study was conducted in treatment-naive adults with drug-susceptible pulmonary tuberculosis in Port-au-Prince, Haiti, to assess the safety, bactericidal activity, and pharmacokinetics of nitazoxanide (NTZ). This was a prospective phase II clinical trial in 30 adults with pulmonary tuberculosis. Twenty participants received 1 g of NTZ orally twice daily for 14 days. A control group of 10 participants received standard therapy over 14 days. The primary outcome was the change in time to culture positivity (TTP) in an automated liquid culture system. The most common adverse events seen in the NTZ group were gastrointestinal complaints and headache. The mean change in TTP in sputum over 14 days in the NTZ group was 3.2 h ± 22.6 h and was not statistically significant ( P = 0.56). The mean change in TTP in the standard therapy group was significantly increased, at 134 h ± 45.2 h ( P < 0.0001). The mean NTZ MIC for Mycobacterium tuberculosis isolates was 12.3 μg/ml; the mean NTZ maximum concentration ( C max ) in plasma was 10.2 μg/ml. Negligible NTZ levels were measured in sputum. At the doses used, NTZ did not show bactericidal activity against M. tuberculosis Plasma concentrations of NTZ were below the MIC, and its negligible accumulation in pulmonary sites may explain the lack of bactericidal activity. (This study has been registered at ClinicalTrials.gov under identifier NCT02684240.).",2020,"The mean change in TTP in the standard therapy group was significantly increased, at 134 hours ± 45.2 (p<0.0001).","['30 adults with pulmonary tuberculosis', 'pulmonary tuberculosis', 'naïve adults with drug-susceptible pulmonary tuberculosis in Port-au-Prince, Haiti']","['nitazoxanide', 'nitazoxanide (NTZ).DesignThis', 'standard therapy', 'NTZ']","['safety, bactericidal activity and pharmacokinetics', 'mean change in TTP', 'mean NTZ plasma C max', 'mean change in TTP in sputum', 'change in time to culture positivity in an automated liquid culture system', 'gastrointestinal complaints and headache', 'mean NTZ minimum inhibitory concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}]","[{'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1436435', 'cui_str': 'NTZ'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity (observable entity)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C1436435', 'cui_str': 'NTZ'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}]",30.0,0.0719608,"The mean change in TTP in the standard therapy group was significantly increased, at 134 hours ± 45.2 (p<0.0001).","[{'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Walsh', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA kfw2001@med.cornell.edu.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McAulay', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Vilbrun', 'Affiliation': ""Groupe Haïtien d'Étude du Sarcome de Kaposi et des Infectieuses Opportunistes, Port-au-Prince, Haiti.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mathurin', 'Affiliation': ""Groupe Haïtien d'Étude du Sarcome de Kaposi et des Infectieuses Opportunistes, Port-au-Prince, Haiti.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jean Francois', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Phoenix, Arizona, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zimmerman', 'Affiliation': 'Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, New Jersey, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kaya', 'Affiliation': 'The Public Health Research Institute at the International Center for Public Health, New Jersey Medical School-Rutgers, The State University of New Jersey, Newark, New Jersey, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Department of Microbiology and Immunology, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ocheretina', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Savic', 'Affiliation': 'Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, New Jersey, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Dartois', 'Affiliation': 'The Public Health Research Institute at the International Center for Public Health, New Jersey Medical School-Rutgers, The State University of New Jersey, Newark, New Jersey, USA.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': ""Groupe Haïtien d'Étude du Sarcome de Kaposi et des Infectieuses Opportunistes, Port-au-Prince, Haiti.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nathan', 'Affiliation': 'Department of Microbiology and Immunology, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Fitzgerald', 'Affiliation': 'Center for Global Health, Weill Cornell Medicine, New York, New York, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01956-19']
271,31687831,Physiological Comparison of High-Flow Nasal Cannula and Helmet Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure.,"Rationale: High-flow nasal cannula (HFNC) and helmet noninvasive ventilation (NIV) are used for the management of acute hypoxemic respiratory failure. Objectives: Physiological comparison of HFNC and helmet NIV in patients with hypoxemia. Methods: Fifteen patients with hypoxemia with Pa O 2 /Fi O 2 < 200 mm Hg received helmet NIV (positive end-expiratory pressure ≥ 10 cm H 2 O, pressure support = 10-15 cm H 2 O) and HFNC (50 L/min) in randomized crossover order. Arterial blood gases, dyspnea, and comfort were recorded. Inspiratory effort was estimated by esophageal pressure (Pes) swings. Pes-simplified pressure-time product and transpulmonary pressure swings were measured. Measurements and Main Results: As compared with HFNC, helmet NIV increased Pa O 2 /Fi O 2 (median [interquartile range]: 255 mm Hg [140-299] vs. 138 [101-172]; P = 0.001) and lowered inspiratory effort (7 cm H 2 O [4-11] vs. 15 [8-19]; P = 0.001) in all patients. Inspiratory effort reduction by NIV was linearly related to inspiratory effort during HFNC ( r = 0.84; P < 0.001). Helmet NIV reduced respiratory rate (24 breaths/min [23-31] vs. 29 [26-32]; P = 0.027), Pes-simplified pressure-time product (93 cm H 2 O ⋅ s ⋅ min -1 [43-138] vs. 200 [168-335]; P = 0.001), and dyspnea (visual analog scale 3 [2-5] vs. 8 [6-9]; P = 0.002), without affecting Pa CO 2 ( P = 0.80) and comfort ( P = 0.50). In the overall cohort, transpulmonary pressure swings were not different between treatments (NIV = 18 cm H 2 O [14-21] vs. HFNC = 15 [8-19]; P = 0.11), but patients exhibiting lower inspiratory effort on HFNC experienced increases in transpulmonary pressure swings with helmet NIV. Higher transpulmonary pressure swings during NIV were associated with subsequent need for intubation. Conclusions: As compared with HFNC in hypoxemic respiratory failure, helmet NIV improves oxygenation, reduces dyspnea, inspiratory effort, and simplified pressure-time product, with similar transpulmonary pressure swings, Pa CO 2 , and comfort.",2020,"As compared to HFNC in hypoxemic respiratory failure, helmet NIV improves oxygenation, reduces dyspnea, inspiratory effort and simplified pressure-time product, with similar transpulmonary pressure swings, PaCO2 and comfort.","['Acute Hypoxemic Respiratory Failure', 'hypoxemic patients', 'Fifteen hypoxemic patients with PaO2/FiO2<200 mmHg received']","['High-Flow Nasal Cannula and Helmet Noninvasive Ventilation', 'HFNC and helmet NIV', 'HFNC', 'flow nasal cannula (HFNC) and helmet noninvasive ventilation (NIV', 'helmet NIV (PEEP≥10 cmH2O, pressure support=10-15 cmH2O) and HFNC']","['respiratory rate', 'PES simplified pressure-time product and transpulmonary pressure swings', 'hypoxemic respiratory failure, helmet NIV improves oxygenation, reduces dyspnea, inspiratory effort and simplified pressure-time product, with similar transpulmonary pressure swings, PaCO2 and comfort', 'transpulmonary pressure swings', 'Arterial blood gases, dyspnea and comfort', 'lowered inspiratory effort', 'PaO2/FiO2', 'PES simplified pressure-time product', 'dyspnea (visual analog scale']","[{'cui': 'C4039867', 'cui_str': 'Acute type 1 respiratory failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0018884', 'cui_str': 'Helmets'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach (qualifier value)'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia (disorder)'}, {'cui': 'C0018884', 'cui_str': 'Helmets'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",335.0,0.371386,"As compared to HFNC in hypoxemic respiratory failure, helmet NIV improves oxygenation, reduces dyspnea, inspiratory effort and simplified pressure-time product, with similar transpulmonary pressure swings, PaCO2 and comfort.","[{'ForeName': 'Domenico Luca', 'Initials': 'DL', 'LastName': 'Grieco', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Luca S', 'Initials': 'LS', 'LastName': 'Menga', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Raggi', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Bongiovanni', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Gian Marco', 'Initials': 'GM', 'LastName': 'Anzellotti', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Eloisa S', 'Initials': 'ES', 'LastName': 'Tanzarella', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Bocci', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Mercurio', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Antonio M', 'Initials': 'AM', 'LastName': ""Dell'Anna"", 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Eleuteri', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bello', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Maviglia', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}, {'ForeName': 'Salvatore Maurizio', 'Initials': 'SM', 'LastName': 'Maggiore', 'Affiliation': ""Department of Medical, Oral and Biotechnological Sciences, School of Medicine and Health Sciences, Section of Anesthesia, Analgesia, Perioperative and Intensive Care, SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Antonelli', 'Affiliation': ""Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.""}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201904-0841OC']
272,32268795,Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial.,"BACKGROUND
Palliative care improves quality of life in patients with heart failure. Whether men and women with heart failure derive similar benefit from palliative care interventions remains unknown.
METHODS
In a secondary analysis of the PAL-HF trial (Palliative Care in Heart Failure), we analyzed differences in quality of life among men and women with heart failure and assessed for differential effects of the palliative care intervention by sex. Differences in clinical characteristics and quality-of-life metrics were compared between men and women at serial time points. The primary outcome was change in Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks.
RESULTS
Among the 71 women and 79 men, there was a significant difference in baseline Kansas City Cardiomyopathy Questionnaire (24.5 versus 36.2, respectively; P =0.04) but not Functional Assessment of Chronic Illness Therapy-Palliative Care scale (115.7 versus 120.3; P =0.27) scores. Among those who received the palliative care intervention (33 women and 42 men), women's quality-of-life score remained lower than that of men after enrollment. Treated men's scores were significantly higher than those untreated (6-month Kansas City Cardiomyopathy Questionnaire, 68.0 [interquartile range, 52.6-85.7] versus 41.1[interquartile range, 32.0-78.3]; P =0.047), whereas the difference between treated and untreated women was not significantly different ( P =0.39). Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.
CONCLUSIONS
In the PAL-HF trial, women with heart failure experienced a greater symptom burden and poorer quality of life as compared with men. The change in treated men's Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks was significantly higher than those untreated; this trend was not observed in women. Thus, there may be a sex disparity in response to palliative care intervention, suggesting that sex-specific approaches to palliative care may be needed to improve outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT0158960.",2020,"Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.
","['patients with heart failure', 'Patients With Advanced Heart Failure', '71 women and 79 men', 'men and women with heart failure']",['palliative care intervention'],"['Kansas City Cardiomyopathy Questionnaire score', 'Quality of Life and Clinical Outcomes', 'baseline Kansas City Cardiomyopathy Questionnaire', 'Rates of death and rehospitalization', 'quality of life', 'change in Kansas City Cardiomyopathy Questionnaire score', ""women's quality-of-life score"", 'symptom burden and poorer quality of life', 'Functional Assessment of Chronic Illness Therapy-Palliative Care scale', 'clinical characteristics and quality-of-life metrics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",71.0,0.195253,"Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.
","[{'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Truby', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA (C.O.).'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Bradi', 'Initials': 'B', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pagidipati', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rymer', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lowenstern', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tulsky', 'Affiliation': ""Division of Palliative Medicine, Department of Medicine, Dana Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA (J.T.).""}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Rogers', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006134']
273,30592991,"A phase II, randomised study of mFOLFOX6 with or without the Akt inhibitor ipatasertib in patients with locally advanced or metastatic gastric or gastroesophageal junction cancer.","BACKGROUND
Akt activation is common in gastric/gastroesophageal junction cancer (GC/GEJC) and is associated with chemotherapy resistance. Treatment with ipatasertib, a pan-Akt inhibitor, may potentiate the efficacy of chemotherapy in GC/GEJC.
PATIENTS AND METHODS
In this randomised, double-blind, placebo-controlled, multicentre, phase II trial, patients with locally advanced or metastatic GC/GEJC not amenable to curative therapy were randomised 1:1 to receive ipatasertib or placebo, plus mFOLFOX6 (modified regimen of leucovorin, bolus and infusional 5-fluorouracil [5-FU], and oxaliplatin). The co-primary end-point was progression-free survival (PFS) in the intent-to-treat (ITT) population and in phosphatase and tensin homolog (PTEN)-low patients. Secondary end-points included PFS in patients with PI3K/Akt pathway-activated tumours; overall survival, investigator-assessed objective response rate and duration of response in the ITT population; and safety assessments.
RESULTS
In 153 enrolled patients, the median PFS (ITT) was 6.6 months (90% confidence interval [CI], 5.7-7.5) with ipatasertib/mFOLFOX6 versus 7.5 months (90% CI, 6.2-8.1) with placebo/mFOLFOX6 (hazard ratio, 1.12; 90% CI, 0.81-1.55; P = 0.56). No statistically significant PFS benefit was observed in biomarker-selected patient subgroups (PTEN-low and PI3K/Akt pathway-activated tumours) with ipatasertib/mFOLFOX6 versus placebo/mFOLFOX6. Other secondary end-points did not favour the ipatasertib/mFOLFOX6 treatment arm. The percentages of patients with ≥1 adverse event (AE, 100% versus 98%) and grade ≥3 AEs (79% versus 74%) were similar between arms. Higher rates of AEs leading to treatment withdrawal (16% versus 6%) and serious AEs were reported in the ipatasertib arm (54% versus 43%). Thirty-nine and 29 deaths occurred in the ipatasertib and placebo arms, respectively.
CONCLUSIONS
Ipatasertib/mFOLFOX6 compared with placebo/mFOLFOX6 did not improve PFS in unselected or biomarker-selected patients. No unexpected safety concerns were observed.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT01896531).",2019,Higher rates of AEs leading to treatment withdrawal (16% versus 6%) and serious AEs were reported in the ipatasertib arm (54% versus 43%).,"['patients with locally advanced or metastatic gastric or gastroesophageal junction cancer', 'patients with locally advanced or metastatic GC/GEJC not amenable to curative therapy']","['ipatasertib or placebo, plus mFOLFOX6 (modified regimen of leucovorin, bolus and infusional 5-fluorouracil [5-FU], and oxaliplatin', 'placebo/mFOLFOX6', 'mFOLFOX6 with or without the Akt inhibitor ipatasertib', 'placebo']","['progression-free survival (PFS', 'PFS', 'PFS benefit', 'median PFS (ITT', 'grade ≥3 AEs', 'PFS in patients with PI3K/Akt pathway-activated tumours; overall survival, investigator-assessed objective response rate\xa0and duration of response\xa0in the ITT population; and safety assessments']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",153.0,0.549442,Higher rates of AEs leading to treatment withdrawal (16% versus 6%) and serious AEs were reported in the ipatasertib arm (54% versus 43%).,"[{'ForeName': 'Y-J', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu Seoul 03080, South Korea. Electronic address: bangyj@snu.ac.kr.'}, {'ForeName': 'Y-K', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, South Korea. Electronic address: ykkang@amc.seoul.kr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ng', 'Affiliation': 'National Cancer Centre Singapore, Singapore. Electronic address: matthew.ng.c.h@singhealth.com.sg.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System, Yonsei-ro 50-1 Seodaemun-gyu Shinchon-dong 134 Seoul 03722, South Korea. Electronic address: unchung8@yuhs.ac.'}, {'ForeName': 'Z A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA. Electronic address: ZWainberg@mednet.ucla.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gendreau', 'Affiliation': 'Genentech, Inc., South San Francisco, CA 94080, USA. Electronic address: gendreau.steven@gene.com.'}, {'ForeName': 'W Y', 'Initials': 'WY', 'LastName': 'Chan', 'Affiliation': 'Genentech, Inc., South San Francisco, CA 94080, USA. Electronic address: wychan4@gmail.com.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Genentech, Inc., South San Francisco, CA 94080, USA. Electronic address: xu.na@gene.com.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Maslyar', 'Affiliation': 'Genentech, Inc., South San Francisco, CA 94080, USA. Electronic address: dmaslyar@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Meng', 'Affiliation': 'Genentech, Inc., South San Francisco, CA 94080, USA. Electronic address: meng.raymond@gene.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom SM2 5PT UK. Electronic address: ian.chau@rmh.nhs.Uk.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ajani', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. Electronic address: jajani@mdanderson.org.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.11.017']
274,32122898,Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients.,"Dalbavancin offers a possible treatment option for infectious peritonitis associated with peritoneal dialysis (PD) due to its coverage of Gram-positive bacteria and pharmacokinetic properties. We aimed to evaluate the clinical pharmacokinetics (PK) and pharmacodynamics of dalbavancin in a prospective, randomized, open-label, crossover PK study of adult patients with end-stage renal disease ESRD who were receiving PD. Sampling occurred prior to a single 30-min infusion of dalbavancin at 1,500 mg and at 1, 2, 3, 4, and 6 h and 7 and 14 days postadministration. Concentration-time data were analyzed via noncompartmental analysis. Pharmacodynamic parameters against common infectious peritonitis-causing pathogens were evaluated. Ten patients were enrolled. Patients were a median of 55 years old and had a median weight of 78.2 kg, 50% were female, and 70% were Caucasian. The terminal plasma half-life of dalbavancin was 181.4 ± 35.5 h. The day 0 to day 14 dalbavancin mean area under the curve (AUC) was 40,573.2 ± 9,800.3 mg·h/liter. The terminal-phase half-life of dalbavancin within the peritoneal fluid was 4.309 × 10 8 ± 1.140 × 10 9 h. The day 0 to day 14 dalbavancin mean peritoneal fluid AUC was 2,125.0 ± 1,794.3 mg·h/liter. The target plasma AUC/MIC was attained with the intravenous dose in all 10 patients for all Staphylococcus and Streptococcus species at the recommended MIC breakpoints. The intraperitoneal arm of the study was stopped early, because the first 3 patients experienced moderate to severe pain and bloating within 1 h following the administration of dalbavancin. Dalbavancin at 1,500 mg administered intravenously can be utilized without dose adjustment in peritoneal dialysis patients and will likely achieve the necessary peritoneal fluid concentrations to treat peritonitis caused by typical Gram-positive pathogens.",2020,AUC/MIC was attained with the intravenous dose in all 10 patients for all Staphylococcus and Streptococcus species at recommended MIC breakpoints.,"['Ten patients were enrolled', 'Patients were a median of 55 years old, 78.2 kg, 50% female, and 70% Caucasian', 'patients receiving PD', 'adult patients with ESRD who were receiving PD', 'peritoneal dialysis patients']","['dalbavancin', 'Dalbavancin']","['L. Target plasma', 'clinical pharmacokinetics (PK) and pharmacodynamics', 'Concentration-time data', 'AUC/MIC', 'severe pain and bloating']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}]","[{'cui': 'C1172636', 'cui_str': 'dalbavancin'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",10.0,0.0301617,AUC/MIC was attained with the intravenous dose in all 10 patients for all Staphylococcus and Streptococcus species at recommended MIC breakpoints.,"[{'ForeName': 'E T', 'Initials': 'ET', 'LastName': 'Van Matre', 'Affiliation': 'Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center College of Pharmacy, Memphis, Tennessee, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Teitelbaum', 'Affiliation': 'Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Kiser', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, Colorado, USA Ty.Kiser@ucdenver.edu.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02089-19']
275,32320061,Effects of acupuncture versus cognitive behavioral therapy on cognitive function in cancer survivors with insomnia: A secondary analysis of a randomized clinical trial.,"BACKGROUND
Cancer-related cognitive impairment is a prevalent, disruptive condition potentially exacerbated by sleep disturbances. The current study was performed to evaluate the effects of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on objective and subjective cognitive function in cancer survivors with insomnia.
METHODS
Using data from a randomized clinical trial (160 survivors) that compared acupuncture versus CBT-I for insomnia occurring in cancer survivors, the authors analyzed cognitive outcomes and their relationship to insomnia symptoms. Analysis was limited to 99 patients who reported baseline cognitive difficulties. Interventions were delivered over 8 weeks. Objective attention, learning, and memory were evaluated using the Buschke Selective Reminding Test. Subjective cognitive function was assessed using the Brown Attention-Deficit Disorder Scales. Insomnia symptoms were assessed using the Insomnia Severity Index. All outcomes were collected at baseline, week 8, and week 20.
RESULTS
From baseline to week 8, acupuncture produced statistically significant within-group improvements in objective attention (Cohen D, 0.29), learning (Cohen D, 0.31), and memory (Cohen D, 0.33) that persisted to week 20 (all P < .05), whereas CBT-I produced a statistically significant within-group improvement in objective attention from baseline to week 20 (Cohen D, 0.50; P < .05); between-group differences were not statistically significant. Both interventions produced statistically significant within-group improvements in subjective cognitive function at weeks 8 and 20 compared with baseline (all P < .001); between-group differences were not statistically significant. In the acupuncture group, patients with clinically meaningful responses with regard to insomnia symptoms demonstrated a significantly greater improvement in subjective cognitive function compared with those without clinically meaningful insomnia responses (P = .006).
CONCLUSIONS
Among cancer survivors with insomnia, both acupuncture and CBT-I produced significant improvements in objective and subjective cognitive function. However, the effect sizes varied and only survivors in the acupuncture group demonstrated a significant relationship between cognitive and sleep outcomes. These preliminary findings warrant further investigation to guide the personalized management of patients with cancer-related cognitive impairment.",2020,Both interventions produced statistically significant within-group improvements in subjective cognitive function at weeks 8 and 20 compared with baseline (all P < .001); between-group differences were not statistically significant.,"['patients with cancer-related cognitive impairment', '99 patients who reported baseline cognitive difficulties', 'cancer survivors with insomnia']","['acupuncture', 'cognitive behavioral therapy', 'acupuncture versus cognitive behavioral therapy']","['subjective cognitive function', 'Brown Attention-Deficit Disorder Scales', 'objective attention', 'cognitive and sleep outcomes', 'Insomnia symptoms', 'objective and subjective cognitive function', 'Subjective cognitive function', 'Objective attention, learning, and memory', 'Insomnia Severity Index', 'cognitive function', 'meaningful insomnia responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",160.0,0.120503,Both interventions produced statistically significant within-group improvements in subjective cognitive function at weeks 8 and 20 compared with baseline (all P < .001); between-group differences were not statistically significant.,"[{'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Liou', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Root', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Q Susan', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Cancer,['10.1002/cncr.32847']
276,32324082,Efficacy and safety of ertugliflozin across racial groups in patients with type 2 diabetes mellitus.,"Objective: To assess the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor ertugliflozin across racial groups in patients with type 2 diabetes mellitus (T2DM). Methods: Pooled analysis of data from randomized, double-blind studies in the ertugliflozin phase III development program. Seven placebo- and comparator-controlled studies were used to assess safety ( N = 4859) and three placebo-controlled studies were used to assess efficacy ( N = 1544). Least-squares (LS) mean change from baseline was calculated for glycated hemoglobin (HbA1c), body weight and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs). Results: At Week 26, ertugliflozin provided a greater reduction in HbA1c, body weight and SBP versus placebo in all racial subgroups. The placebo-adjusted LS mean change (95% confidence interval) from baseline in HbA1c was -0.8% (-1.0, -0.7) and -1.0% (-1.1, -0.8) with ertugliflozin 5 mg and 15 mg, respectively, in the White subgroup, -0.7% (-1.2, -0.2) and -0.8% (-1.3, -0.3) in the Black subgroup, and -0.8% (-1.1, -0.5) and -1.0% (-1.3, -0.8) in the Asian subgroup. The incidences of overall AEs, serious AEs and AEs leading to discontinuation from study medication were similar between the ertugliflozin 5 mg, 15 mg and non-ertugliflozin groups within each racial subgroup. The incidence of female genital mycotic infection (GMI) was higher with ertugliflozin than non-ertugliflozin across all racial subgroups. The incidence of male GMI was higher with ertugliflozin than non-ertugliflozin in the White sub-group; however, there were few male GMI events in the non-White subgroups. Conclusions: In patients with T2DM, treatment with ertugliflozin improved HbA1c, body weight and SBP across all racial subgroups. Ertugliflozin had a generally similar safety profile across racial subgroups and was generally well tolerated. Clinicaltrials.gov identifiers: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.",2020,"At Week 26, ertugliflozin provided a greater reduction in HbA1c, body weight and SBP versus placebo in all racial subgroups.","['patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['Ertugliflozin', 'sodium-glucose cotransporter 2 inhibitor ertugliflozin', 'placebo', 'ertugliflozin']","['incidence of female genital mycotic infection (GMI', 'efficacy and safety', 'tolerated', 'glycated hemoglobin (HbA1c), body weight, and systolic blood pressure (SBP', 'HbA1c, body weight, and SBP', 'HbA1c, body weight and SBP', 'incidence of male GMI', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017421', 'cui_str': 'Female genital'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",,0.166963,"At Week 26, ertugliflozin provided a greater reduction in HbA1c, body weight and SBP versus placebo in all racial subgroups.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tarasenko', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1760228']
277,32175593,Topical benzoyl peroxide for acne.,"BACKGROUND
Acne is a common, economically burdensome condition that can cause psychological harm and, potentially, scarring. Topical benzoyl peroxide (BPO) is a widely used acne treatment; however, its efficacy and safety have not been clearly evaluated.
OBJECTIVES
To assess the effects of BPO for acne.
SEARCH METHODS
We searched the following databases up to February 2019: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of relevant randomised controlled trials (RCTs) and systematic reviews.
SELECTION CRITERIA
We included RCTs that compared topical BPO used alone (including different formulations and concentrations of BPO) or as part of combination treatment against placebo, no treatment, or other active topical medications for clinically diagnosed acne (used alone or in combination with other topical drugs not containing BPO) on the face or trunk.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as expected by Cochrane. Primary outcome measures were 'participant global self-assessment of acne improvement' and 'withdrawal due to adverse events in the whole course of a trial'. 'Percentage of participants experiencing any adverse event in the whole course of a trial' was a key secondary outcome.
MAIN RESULTS
We included 120 trials (29,592 participants randomised in 116 trials; in four trials the number of randomised participants was unclear). Ninety-one studies included males and females. When reported, 72 trials included participants with mild to moderate acne, 26 included participants with severe acne, and the mean age of participants ranged from 18 to 30 years. Our included trials assessed BPO as monotherapy, as add-on treatment, or combined with other active treatments, as well as BPO of different concentrations and BPO delivered through different vehicles. Comparators included different concentrations or formulations of BPO, placebo, no treatment, or other active treatments given alone or combined. Treatment duration in 80 trials was longer than eight weeks and was only up to 12 weeks in 108 trials. Industry funded 50 trials; 63 trials did not report funding. We commonly found high or unclear risk of performance, detection, or attrition bias. Trial setting was under-reported but included hospitals, medical centres/departments, clinics, general practices, and student health centres. We reported on outcomes assessed at the end of treatment, and we classified treatment periods as short-term (two to four weeks), medium-term (five to eight weeks), or long-term (longer than eight weeks). For 'participant-reported acne improvement', BPO may be more effective than placebo or no treatment (risk ratio (RR) 1.27, 95% confidence interval (CI) 1.12 to 1.45; 3 RCTs; 2234 participants; treatment for 10 to 12 weeks; low-certainty evidence). Based on low-certainty evidence, there may be little to no difference between BPO and adapalene (RR 0.99, 95% CI 0.90 to 1.10; 5 RCTs; 1472 participants; treatment for 11 to 12 weeks) or between BPO and clindamycin (RR 0.95, 95% CI 0.68 to 1.34; 1 RCT; 240 participants; treatment for 10 weeks) (outcome not reported for BPO versus erythromycin or salicylic acid). For 'withdrawal due to adverse effects', risk of treatment discontinuation may be higher with BPO compared with placebo or no treatment (RR 2.13, 95% CI 1.55 to 2.93; 24 RCTs; 13,744 participants; treatment for 10 to 12 weeks; low-certainty evidence); the most common causes of withdrawal were erythema, pruritus, and skin burning. Only very low-certainty evidence was available for the following comparisons: BPO versus adapalene (RR 1.85, 95% CI 0.94 to 3.64; 11 RCTs; 3295 participants; treatment for 11 to 24 weeks; causes of withdrawal not clear), BPO versus clindamycin (RR 1.93, 95% CI 0.90 to 4.11; 8 RCTs; 3330 participants; treatment for 10 to 12 weeks; causes of withdrawal included local hypersensitivity, pruritus, erythema, face oedema, rash, and skin burning), erythromycin (RR 1.00, 95% CI 0.07 to 15.26; 1 RCT; 60 participants; treatment for 8 weeks; withdrawal due to dermatitis), and salicylic acid (no participants had adverse event-related withdrawal; 1 RCT; 59 participants; treatment for 12 weeks). There may be little to no difference between these groups in terms of withdrawal; however, we are unsure of the results because the evidence is of very low certainty. For 'proportion of participants experiencing any adverse event', very low-certainty evidence leaves us uncertain about whether BPO increased adverse events when compared with placebo or no treatment (RR 1.40, 95% CI 1.15 to 1.70; 21 RCTs; 11,028 participants; treatment for 10 to 12 weeks), with adapalene (RR 0.71, 95% CI 0.50 to 1.00; 7 RCTs; 2120 participants; treatment for 11 to 24 weeks), with erythromycin (no participants reported any adverse events; 1 RCT; 89 participants; treatment for 10 weeks), or with salicylic acid (RR 4.77, 95% CI 0.24 to 93.67; 1 RCT; 41 participants; treatment for 6 weeks). Moderate-certainty evidence shows that the risk of adverse events may be increased for BPO versus clindamycin (RR 1.24, 95% CI 0.97 to 1.58; 6 RCTs; 3018 participants; treatment for 10 to 12 weeks); however, the 95% CI indicates that BPO might make little to no difference. Most reported adverse events were mild to moderate, and local dryness, irritation, dermatitis, erythema, application site pain, and pruritus were the most common.
AUTHORS' CONCLUSIONS
Current evidence suggests that BPO as monotherapy or add-on treatment may be more effective than placebo or no treatment for improving acne, and there may be little to no difference between BPO and either adapalene or clindamycin. Our key efficacy evidence is based on participant self-assessment; trials of BPO versus erythromycin or salicylic acid did not report this outcome. For adverse effects, the evidence is very uncertain regarding BPO compared with adapalene, erythromycin, or salicylic acid. However, risk of treatment discontinuation may be higher with BPO compared with placebo or no treatment. Withdrawal may be linked to tolerability rather than to safety. Risk of mild to moderate adverse events may be higher with BPO compared with clindamycin. Further trials should assess the comparative effects of different preparations or concentrations of BPO and combination BPO versus monotherapy. These trials should fully assess and report adverse effects and patient-reported outcomes measured on a standardised scale.",2020,Primary outcome measures were 'participant global self-assessment of acne improvement' and 'withdrawal due to adverse events in the whole course of a trial'. ',"['Ninety-one studies included males and females', '120 trials (29,592 participants randomised in 116 trials; in four trials the number of randomised participants was unclear', 'clinically diagnosed acne (used alone or in combination with other topical drugs not containing BPO) on the face or trunk', '72 trials included participants with mild to moderate acne, 26 included participants with severe acne, and the mean age of participants ranged from 18 to 30 years', 'Trial setting was under-reported but included hospitals, medical centres/departments, clinics, general practices, and student health centres']","['BPO and combination BPO versus monotherapy', 'BPO versus adapalene', 'adapalene, erythromycin, or salicylic acid', 'clindamycin', 'adapalene', 'erythromycin or salicylic acid', 'Topical benzoyl peroxide', 'placebo', 'salicylic acid', 'erythromycin', 'BPO, placebo', 'Topical benzoyl peroxide (BPO']","['adverse events', 'withdrawal included local hypersensitivity, pruritus, erythema, face oedema, rash, and skin burning), erythromycin', 'erythema, pruritus, and skin burning', 'local dryness, irritation, dermatitis, erythema, application site pain, and pruritus', ""participant global self-assessment of acne improvement' and 'withdrawal due to adverse events""]","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C0165631', 'cui_str': 'adapalene'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0036080', 'cui_str': 'Salicylic Acids'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0542571', 'cui_str': 'Edema of face (finding)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0521491', 'cui_str': 'Application site pain (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]",29592.0,0.366858,Primary outcome measures were 'participant global self-assessment of acne improvement' and 'withdrawal due to adverse events in the whole course of a trial'. ',"[{'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""School of Clinical Medicine, University of Cambridge, Primary Care Unit, Department of Public Health and Primary Care, Strangeways Research Laboratory, 2 Worts' Causeway, Cambridge, UK, CB1 8RN.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'McMaster University, Department of Health Research Methods, Evidence, and Impact, 1280 Main Street West, Hamilton, ON, Canada, L8S 4K1.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Lazic Mosler', 'Affiliation': 'Catholic University of Croatia, Department of Nursing, Ilica 242, Zagreb, Croatia, 10000.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'School of Public Health, Peking University, Centre for Evidence Based Medicine and Clinical Research, Department of Epidemiology and Biostatistics, Beijing, China, 100191.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Peking University First Hospital, Department of Dermatology and Venereology, 8 Xishiku Main Street, Beijing, Xicheng District, China, 100034.'}, {'ForeName': 'Yanchang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Yale School of Public Health, Department of Chronic Disease Epidemiology, 367 Cedar ST RM 704, New Haven, Connecticut, USA, 06510.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Xuanwu Hospital, Capital Medical University, Department of Neurology, Changchun Street 45, Beijing, China, 100053.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""The University of Nottingham, c/o Cochrane Skin Group, A103, King's Meadow Campus, Lenton Lane, Nottingham, UK, NG7 2NR.""}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011154.pub2']
278,32321767,Quality of life of locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial): a randomized phase II trial.,"OBJECTIVE
The CIRCE trial (NCT01973101) investigated the efficacy, safety, and quality of life of the addition of neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation for locally advanced cervical cancer (stages IIB-IVA). The impact of both treatment arms on quality of life is reported in the present study.
METHODS
Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment. Linear mixed models were fitted to analyze differences in quality of life over time and between groups. Differences in mean quality of life scales >10 points and p<0.05 were considered clinically relevant and statistically significant, respectively. Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire. Excluded were patients who did not complete any quality of life questionnaire. Relevant exclusion criteria for the CIRCE trial included Eastern Cooperative Oncology Group performance status >2 and peripheral neuropathy >2. Mann-Whitney U tests were performed to assess differences between groups in quality of life at baseline. To evaluate differences between treatment arms, linear mixed models were fitted using the transformed quality of life scores as a dependent variable and time of follow-up and study arm as factors.
RESULTS
A total of 107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm). Quality of life compliance rates were higher for the chemoradiation group at every assessment time (ranging from 75-86.5% in the chemoradiation arm vs 55-81.8% in the neoadjuvant chemotherapy arm). For quality of life results at baseline, no statistically significant difference between the groups was seen. For both groups, most scales showed improvements over time, except for worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms. For chemoradiation, body image was lower (p<0.001) and patients presented more lymphedema (p<0.001) and sexual worry (p<0.001) at 12 months compared with baseline. Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01). At 12 months, clinical differences were seen only for body image and menopausal symptoms scale, with neoadjuvant chemotherapy presenting better body image scores and a lower burden of menopausal symptoms.
CONCLUSION
After treatment for locally advanced cervical cancer, patients improved in most quality of life aspects. However, worsening was observed in sexual enjoyment, peripheral neuropathy, and menopausal symptoms. To improve patients' quality of life, efforts should be made to prevent and treat these long term effects of locally advanced cervical cancer treatment.",2020,"Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01).","['Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire', 'locally advanced cervical cancer (stages IIB-IVA', '107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm', 'Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment', 'locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial']","['neoadjuvant chemotherapy', 'neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation']","['Quality of life', 'sexual/vaginal functioning', 'Quality of life compliance rates', 'menopausal symptoms scale', 'quality of life questionnaire', 'mean quality of life scales', 'body image and menopausal symptoms scale', 'worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms', 'sexual enjoyment, peripheral neuropathy, and menopausal symptoms', 'quality of life', 'lymphedema (p<0.001) and sexual worry', 'efficacy, safety, and quality of life']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424403', 'cui_str': 'Erotic feeling'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",107.0,0.0959925,"Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01).","[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Nunes de Arruda', 'Affiliation': 'Sao Paulo University Faculty of Medicine, Sao Paulo, Brazil fernanda.arruda@fm.usp.br.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'da Costa', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Bonadio', 'Affiliation': 'Oncology, Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Abraão', 'Initials': 'A', 'LastName': 'Dornellas', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pereira', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Geertruida H', 'Initials': 'GH', 'LastName': 'de Bock', 'Affiliation': 'Epidemiology, University of Groningen Faculty of Medical Sciences, Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Pilar Estevez Diz', 'Affiliation': 'Radiology and Oncology, Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001134']
279,32319154,Cost-effectiveness of a specialist smoking cessation package compared with standard smoking cessation services for people with severe mental illness in England: a trial-based economic evaluation from the SCIMITAR+ study.,"AIMS
To evaluate the cost-effectiveness of a specialist smoking cessation package for people with severe mental illness DESIGN: Incremental cost-effectiveness analysis was undertaken from the UK National Health Service and Personal Social Services perspective over a 12-month time horizon. Total costs, including smoking cessation, health-care and social services costs and quality-adjusted life years (QALYs), derived from the five-level EuroQol 5-dimension (EQ-5D-5 L), collected from a randomized controlled trial, were used as outcome measures. The bootstrap technique was employed to assess the uncertainty.
SETTING
Sixteen primary care and 21 secondary care mental health sites in England.
PARTICIPANTS
Adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses (n = 526).
INTERVENTION AND COMPARATOR
A bespoke smoking cessation (BSC) package for people with severe mental illness offered up to 12 individual sessions with a mental health smoking cessation practitioner versus usual care (UC). Of the participants who were randomized, 261 were in UC group and 265 were in BSC group.
MEASUREMENTS
BSC intervention cost was estimated from the treatment log. Costs of UC, health-care and social services and EQ-5D-5 L were collected at baseline, 6- and 12-month follow-ups. Incremental costs and incremental QLAYs were estimated using regression adjusting for respective baseline values and other baseline covariates.
FINDINGS
The mean total cost in the BSC group was £270 [95% confidence interval (CI) = -£1690 to £1424] lower than in the UC group, while the mean QALYs were 0.013 (95% CI = -0.008 to 0.045) higher, leading to BSC dominating UC (76% probability of cost-effective at £20 000/QALY).
CONCLUSIONS
A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.",2020,A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.,"['Adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses (n=526', 'Sixteen primary care and 21 secondary care mental health sites in England PARTICIPANTS', 'people with severe mental illness', 'people with severe mental illness in England', 'participants who were randomised, 261 were in UC group and 265 were in BSC group']","['BSC) package', 'mental health smoking cessation practitioner versus usual care (UC', 'bespoke smoking cessation package', 'AND COMPARATOR\n\n\nA bespoke smoking cessation', 'standard smoking cessation services', 'specialist smoking cessation package']","['BSC intervention cost', 'mean total cost', 'cost-effectiveness', 'Incremental costs and incremental QLAYs', 'Cost-effectiveness', 'Total costs, including smoking cessation, healthcare and social services costs, and quality-adjusted life years (QALYs), derived from EQ-5D-5L', 'Costs of UC, healthcare and social services, and EQ-5D-5L']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.132121,A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.,"[{'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heron', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Crosland', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Addiction (Abingdon, England)",['10.1111/add.15086']
280,32071051,"In Vitro Activity of Ceftazidime-Avibactam against Isolates from Respiratory and Blood Specimens from Patients with Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia, in a Phase 3 Clinical Trial.","Nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP), is increasingly associated with multidrug-resistant Gram-negative pathogens. This study describes the in vitro activity of ceftazidime-avibactam, ceftazidime, and relevant comparator agents against bacterial pathogens isolated from patients with NP, including VAP, enrolled in a ceftazidime-avibactam phase 3 trial. Gram-positive pathogens were included if coisolated with a Gram-negative pathogen. In vitro susceptibility was determined at a central laboratory using Clinical and Laboratory Standards Institute broth microdilution methods. Of 817 randomized patients, 457 (55.9%) had ≥1 Gram-negative bacterial pathogen(s) isolated at baseline, and 149 (18.2%) had ≥1 Gram-positive pathogen(s) coisolated. The most common isolated pathogens were Klebsiella pneumoniae (18.8%), Pseudomonas aeruginosa (15.8%), and Staphylococcus aureus (11.5%). Ceftazidime-avibactam was highly active in vitro against 370 isolates of Enterobacteriaceae , with 98.6% susceptible (MIC 90 , 0.5 μg/ml) compared with 73.2% susceptible for ceftazidime (MIC 90 , >64 μg/ml). The percent susceptibility values for ceftazidime-avibactam and ceftazidime against 129 P. aeruginosa isolates were 88.4% and 72.9% (MIC 90 values of 16 μg/ml and 64 μg/ml), respectively. Among ceftazidime-nonsusceptible Gram-negative isolates, ceftazidime-avibactam percent susceptibility values were 94.9% for 99 Enterobacteriaceae and 60.0% for 35 P. aeruginosa MIC 90 values for linezolid and vancomycin (permitted per protocol for Gram-positive coverage) were within their respective MIC susceptibility breakpoints against the Gram-positive pathogens isolated. This analysis demonstrates that ceftazidime-avibactam was active in vitro against the majority of Enterobacteriaceae and P. aeruginosa isolates from patients with NP, including VAP, in a phase 3 trial. (This study has been registered at ClinicalTrials.gov under identifier NCT01808092.).",2020,"Ceftazidime-avibactam was highly active in vitro against 370 isolates of Enterobacteriaceae , with 98.6% susceptible (","['patients with NP, including VAP, enrolled in a', 'Of 817 randomized patients, 457 (55.9%) had ≥1 Gram-negative bacterial pathogen isolated at baseline, and 149 (18.2%) had ≥1 Gram-positive pathogen co-isolated', 'Patients with Nosocomial Pneumonia, including Ventilator-Associated Pneumonia']","['ceftazidime', 'ceftazidime (MIC 90 ', 'ceftazidime-avibactam, ceftazidime', 'linezolid and vancomycin', 'Ceftazidime-avibactam', 'Ceftazidime-Avibactam', 'ceftazidime-avibactam and ceftazidime', 'ceftazidime-avibactam']","['Nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1443237', 'cui_str': 'Nosocomial Pneumonia'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C3656596', 'cui_str': 'avibactam / Ceftazidime'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C1443237', 'cui_str': 'Nosocomial Pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",817.0,0.30059,"Ceftazidime-avibactam was highly active in vitro against 370 isolates of Enterobacteriaceae , with 98.6% susceptible (","[{'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Stone', 'Affiliation': 'Pfizer, Groton, Connecticut, USA GregoryG.Stone@pfizer.com.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Bradford', 'Affiliation': 'AstraZeneca Pharmaceuticals, Waltham, Massachusetts, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tawadrous', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'TaylorMade Health, Ltd, Warrington, United Kingdom.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Cadatal', 'Affiliation': 'Pfizer, Manila, Philippines.'}, {'ForeName': 'Zhangjing', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'AstraZeneca, Shanghai, China.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Chow', 'Affiliation': 'Pfizer, Collegeville, Pennsylvania, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02356-19']
281,32127394,Patient-Reported Outcomes from the Phase III Randomized IMmotion151 Trial: Atezolizumab + Bevacizumab versus Sunitinib in Treatment-Naïve Metastatic Renal Cell Carcinoma.,"PURPOSE
Patient-reported outcomes (PRO) were evaluated in the phase III IMmotion151 trial (NCT02420821) to inform overall treatment/disease burden of atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (mRCC).
PATIENTS AND METHODS
Patients were randomized 1:1 to receive atezolizumab 1,200 mg intravenous (i.v.) infusions every 3 weeks (q3w) plus bevacizumab 15 mg/kg i.v. q3w or sunitinib 50 mg per day orally 4 weeks on/2 weeks off. Patients completed the MD Anderson Symptom Inventory (MDASI), National Comprehensive Cancer Network Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19), and Brief Fatigue Inventory (BFI) at baseline, q3w during treatment, at end of treatment, and during survival follow-up. Longitudinal and time to deterioration (TTD) analyses for core and RCC symptoms and their interference with daily life, treatment side-effect bother, and health-related quality of life (HRQOL) were evaluated.
RESULTS
The intent-to-treat population included 454 and 461 patients in the atezolizumab plus bevacizumab and sunitinib arms, respectively. Completion rates for each instrument were 83% to 86% at baseline and ≥ 70% through week 54. Milder symptoms, less symptom interference and treatment side-effect bother, and better HRQOL at most visits were reported with atezolizumab plus bevacizumab versus sunitinib. The TTD HR (95% CI) favored atezolizumab plus bevacizumab for core (HR, 0.50; 0.40-0.62) and RCC symptoms (HR, 0.45; 0.37-0.55), symptom interference (HR, 0.56; 0.46-0.68), and HRQOL (HR, 0.68; 0.58-0.81).
CONCLUSIONS
PROs in IMmotion151 suggest lower overall treatment burden with atezolizumab plus bevacizumab compared with sunitinib in patients with treatment-naïve mRCC and provide further evidence for clinical benefit of this regimen.",2020,"Milder symptoms, less symptom interference and treatment side-effect bother, and better HRQOL at most visits were reported with atezolizumab plus bevacizumab versus sunitinib.","['Patients', 'The ITT population included 454 and 461 patients in the', 'patients with treatment-naive mRCC', 'patients with previously untreated metastatic renal cell carcinoma (mRCC', 'treatment-naive metastatic renal cell carcinoma']","['atezolizumab + bevacizumab vs sunitinib', 'atezolizumab plus bevacizumab and sunitinib', 'atezolizumab plus bevacizumab versus sunitinib', 'atezolizumab 1200 mg IV q3w plus bevacizumab 15 mg/kg IV q3w or sunitinib 50 mg PO QD 4 weeks', 'atezolizumab plus bevacizumab']","['Longitudinal and time to deterioration (TTD) analyses for core and RCC symptoms and their interference with daily life, treatment side-effect bother, and health-related quality of life (HRQOL', 'Milder symptoms, less symptom interference and treatment side-effect bother, and better HRQOL', 'RCC symptoms', 'MD Anderson Symptom Inventory (MDASI), National Comprehensive Cancer Network Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19), and Brief Fatigue Inventory (BFI', 'symptom interference', 'Completion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1696717', 'cui_str': 'sunitinib 50 MG [Sutent]'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.171924,"Milder symptoms, less symptom interference and treatment side-effect bother, and better HRQOL at most visits were reported with atezolizumab plus bevacizumab versus sunitinib.","[{'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia. mba41@georgetown.edu.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute and the Royal Free Hospital, Queen Mary University of London, London, UK.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suarez', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Azienda Ospedaliera Santa Maria, Terni, Italy.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'The University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Paris Descartes University, Paris, France.'}, {'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Elaine T', 'Initials': 'ET', 'LastName': 'Lam', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Grüllich', 'Affiliation': 'National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Caroleen', 'Initials': 'C', 'LastName': 'Quach', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Susheela', 'Initials': 'S', 'LastName': 'Carroll', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Beiying', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Qian Cindy', 'Initials': 'QC', 'LastName': 'Zhu', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Piault-Louis', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schiff', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2838']
282,31449805,Hypnotherapy or medications: a randomized noninferiority trial in urgency urinary incontinent women.,"BACKGROUND
Urgency urinary incontinence afflicts many adults, and most commonly affects women. Medications, a standard treatment, may be poorly tolerated, with poor adherence. This warrants investigation of alternative interventions. Mind-body therapies such as hypnotherapy may offer additional treatment options for individuals with urgency urinary incontinence.
OBJECTIVE
To evaluate hypnotherapy's efficacy compared to medications in treating women with urgency urinary incontinence.
MATERIALS AND METHODS
This investigator-masked, noninferiority trial compared hypnotherapy to medications at an academic center in the southwestern United States, and randomized women with non-neurogenic urgency urinary incontinence to weekly hypnotherapy sessions for 2 months (and continued self-hypnosis thereafter) or to medication and weekly counseling for 2 months (and medication alone thereafter). The primary outcome was the between-group comparison of percent change in urgency incontinence on a 3-day bladder diary at 2 months. Important secondary outcomes were between-group comparisons of percent change in urgency incontinence at 6 and 12 months. Outcomes were analyzed based on noninferiority margins of 5% for between group differences (P < 0.025) (that is, for between group difference in percentage change in urgency incontinence, if the lower bound of the 95% confidence interval was greater than -5%, noninferiority would be proved).
RESULTS
A total of 152 women were randomized to treatment between April 2013 and October 2016. Of these women, 142 (70 hypnotherapy, 72 medications) had 3-day diary information at 2 months and were included in the primary outcome analysis. Secondary outcomes were analyzed for women with diary data at the 6-month and then 12-month time points (138 women [67 hypnotherapy, 71 medications] at 6 months, 140 women [69 hypnotherapy, 71 medications] at 12 months. There were no differences between groups' urgency incontinence episodes at baseline: median (quartile 1, quartile 3) for hypnotherapy was 8 (4, 14) and medication was 7 (4, 11) (P = .165). For the primary outcome, although both interventions showed improvement, hypnotherapy did not prove noninferior to medication at 2 months. Hypnotherapy's median percent improvement was 73.0% (95% confidence interval, 60.0-88˖9%), whereas medication's improvement was 88.6% (95% confidence interval, 78.6-100.0%). The median difference in percent change between groups was 0% (95% confidence interval, -16.7% to 0.0%); because the lower margin of the confidence interval did not meet the predetermined noninferiority margin of greater than -5%, hypnotherapy did not prove noninferior to medication. In contrast, hypnotherapy was noninferior to medication for the secondary outcomes at 6 months (hypnotherapy, 85.7% improvement, 95% confidence interval, 75.0-100%; medications, 83.3% improvement, 95% confidence interval, 64.7-100%; median difference in percent change between groups of 0%, 95% confidence interval, 0.0-6.7%) and 12 months (hypnotherapy, 85.7% improvement, 95% confidence interval, 66.7-94.4%; medications, 80% improvement, 95% confidence interval, 54.5-100%; median difference in percent change between groups of 0%, 95% confidence interval, -4.2% to -9.5%).
CONCLUSION
Both hypnotherapy and medications were associated with substantially improved urgency urinary incontinence at all follow-up. The study did not prove the noninferiority of hypnotherapy compared to medications at 2 months, the study's primary outcome. Hypnotherapy proved noninferior to medications at longer-term follow-up of 6 and 12 months. Hypnotherapy is a promising, alternative treatment for women with UUI.",2020,"For the primary outcome, while both interventions showed improvement, hypnotherapy did not prove non-inferior to medication at 2 months.","['Urgency Urinary Incontinent Women', 'One hundred fifty-two women were randomized to treatment between April 2013-October 2016', 'women with UUI', 'women with urgency urinary incontinence', 'at a Southwestern U.S. academic center and randomized women with non-neurogenic urgency urinary incontinence to weekly', 'One-hundred forty-two women (70 hypnotherapy, 72 medications) had']","['hypnotherapy to medications', 'hypnotherapy', 'Hypnotherapy or Medications', 'Hypnotherapy', 'hypnotherapy sessions']","[""medication's improvement"", 'urgency incontinence on 3-day bladder diary', '3-day diary information', 'urgency incontinence episodes', 'urgency incontinence', 'urgency urinary incontinence']","[{'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0231238', 'cui_str': 'Incontinent (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}]","[{'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]",152.0,0.358084,"For the primary outcome, while both interventions showed improvement, hypnotherapy did not prove non-inferior to medication at 2 months.","[{'ForeName': 'Yuko M', 'Initials': 'YM', 'LastName': 'Komesu', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM. Electronic address: ykomesu@salud.unm.edu.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Schrader', 'Affiliation': 'University of New Mexico Clinical and Translational Science Center, Albuquerque, NM.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM; University of Texas Dell Medical School, Austin, TX.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sapien', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Mayer', 'Affiliation': 'Mind Research Network, Albuquerque, NM.'}, {'ForeName': 'Loren H', 'Initials': 'LH', 'LastName': 'Ketai', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.08.025']
283,31641214,Preoperative liking and wanting for sweet beverages as predictors of body weight loss after Roux-en-Y gastric bypass and sleeve gastrectomy.,"BACKGROUND/OBJECTIVES
Patients who receive Roux-en-Y gastric bypass (RYGB) lose more weight than those who receive vertical sleeve gastrectomy (VSG). RYGB and VSG alter hedonic responses to sweet flavor, but whether baseline differences in hedonic responses modulate weight loss after RYGB or VSG remains untested.
PARTICIPANTS/METHODS
Male and female candidates (n = 66) for RYGB or VSG were recruited and tested for their subjective liking and wanting ratings of sucrose solutions and flavored beverages sweetened with aspartame. Participants were classified by unsupervised hierarchical clustering for their liking and wanting ratings of sucrose and aspartame. Participant liking ratings were also used in a supervised classification using pre-established categories of liking ratings (liker, disliker, and inverted u-shape). Effects of categories obtained from unsupervised or supervised classification on body weight loss and their interaction with surgery type were analyzed separately at 3 and 12 months after surgery using linear models corrected for sex and age.
RESULTS
RYGB participants lost more body weight compared with VSG participants at 3 and 12 months after surgery (P < 0.001 for both time points). Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame. RYGB participants in high-wanting clusters based on sucrose, but not aspartame, lost more weight than VSG at both 3 (P = 0.01) and 12 months (P = 0.03), yielding a significant cluster by surgery interaction. Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
CONCLUSIONS
Classification of patients into high/low-wanting ratings for sucrose before surgery can predict differential body weight loss after RYGB or VSG in adults and could be used to advise on surgery type.",2020,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","['Patients who receive', 'Male and female candidates (n\u2009=\u200966) for RYGB or VSG']","['Roux-en-Y gastric bypass and sleeve gastrectomy', 'Preoperative liking and wanting for sweet beverages', 'RYGB and VSG', 'Roux-en-Y gastric bypass (RYGB', 'vertical sleeve gastrectomy (VSG', 'sucrose solutions and flavored beverages sweetened with aspartame', 'Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame']","['Participant liking ratings', 'body weight', 'body weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0158572,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","[{'ForeName': 'Claudio E', 'Initials': 'CE', 'LastName': 'Perez-Leighton', 'Affiliation': 'Department of Physiology, School of Biological Sciences, Pontificia Universidad Católica, Santiago, Chile.'}, {'ForeName': 'Jeon D', 'Initials': 'JD', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Shoran', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Laferrère', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Xavier Pi-Sunyer', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Albu', 'Affiliation': ""Mt. Sinai St. Luke's Hospital, New York, NY, USA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'NutriSci Incorporated, Mt. Kisco, NY, USA.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Kissileff', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA. Harry.Kissileff2@mountsinai.org.'}]",International journal of obesity (2005),['10.1038/s41366-019-0474-1']
284,32320844,Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers.,"INTRODUCTION
Persons living with Alzheimer's disease and related dementias (ADRD) frequently experience pain and behavioral and psychological symptoms of dementia (BPSD) which decrease quality of life (QOL) and influence caregiver burden. Home healthcare professionals however may underrecognize or lack the ability to manage BPSD.
INTERVENTION
This protocol describes an ADRD palliative quality assurance performance improvement program for home healthcare, Aliviado Dementia Care-Home Health Edition. It includes training, mentoring, and a toolbox containing intervention strategies.
METHODS
This embedded pragmatic clinical trial will utilize a multi-site, cluster randomized control design. Recruitment will occur from three home healthcare agencies located in New Jersey, Utah, and Florida. At each agency, care teams will be randomized as clusters and assigned to either the Aliviado Dementia Care program or usual care. We plan to enroll 345 persons living with ADRD and their informal caregiver dyads. The primary outcome will be to measure QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions. Secondary outcomes in the person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use. Secondary outcomes in caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization.
CONCLUSION
This study will be the first large-scale embedded pragmatic clinical trial in home healthcare focused on care quality and outcomes in addressing QOL in ADRD. If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
TRIAL REGISTRATION
Clinical Trials.gov: NCT03255967.",2020,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[""Persons living with Alzheimer's disease and related dementias (ADRD"", '345 persons living with ADRD and their informal caregiver dyads', 'persons living with dementia and their informal caregivers']","['Aliviado Dementia Care', 'Aliviado Dementia Care program or usual care']","['caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization', 'person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use', 'quality of life (QOL', 'quality of life', 'QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.117164,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[{'ForeName': 'Alycia A', 'Initials': 'AA', 'LastName': 'Bristol', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Convery', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sotelo', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Schneider', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Shih-Yin', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fletcher', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Rupper', 'Affiliation': 'University of Utah School of Medicine, United States; George E. Wahlen Department of Veterans Affairs Medical Center, VA Salt Lake City Health Care System, Geriatric Research, Education and Clinical Center, Salt Lake City, UT, United States.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Galvin', 'Affiliation': 'Comprehensive Center for Brain Health, University of Miami Miller School of Medicine, United States.'}, {'ForeName': 'Abraham A', 'Initials': 'AA', 'LastName': 'Brody', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States. Electronic address: Ab.Brody@nyu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106005']
285,32094127,Comparison of Treatment Outcomes between Analysis Populations in the RESTORE-IMI 1 Phase 3 Trial of Imipenem-Cilastatin-Relebactam versus Colistin plus Imipenem-Cilastatin in Patients with Imipenem-Nonsusceptible Bacterial Infections.,"The RESTORE-IMI 1 phase 3 trial demonstrated the efficacy and safety of imipenem-cilastatin (IMI) combined with relebactam (REL) for treating imipenem-nonsusceptible infections. The objective of this analysis was to compare the outcomes among patients meeting eligibility requirements based on central laboratory susceptibility versus local laboratory susceptibility. Patients with serious infections caused by imipenem-nonsusceptible, colistin-susceptible, and imipenem-REL-susceptible pathogens were randomized 2:1 to IMI-REL plus placebo or colistin plus IMI for 5 to 21 days. The primary endpoint was a favorable overall response. Key endpoints included the clinical response and all-cause mortality. We compared outcomes between the primary microbiological modified intent-to-treat (mMITT) population, where eligibility was based on central laboratory susceptibility testing, and the supplemental mMITT (SmMITT) population, where eligibility was based on local, site-level testing. The SmMITT ( n = 41) and MITT ( n = 31) populations had similar baseline characteristics, including sex, age, illness severity, and renal function. In both analysis populations, favorable overall response rates in the IMI-REL treatment group were >70%. Favorable clinical response rates at day 28 were 71.4% for IMI-REL and 40.0% for colistin plus IMI in the mMITT population, whereas they were 75.0% for IMI-REL and 53.8% for colistin plus IMI in the SmMITT population. Day 28 all-cause mortality rates were 9.5% for IMI-REL and 30.0% for colistin plus IMI in the mMITT population, whereas they were 10.7% for IMI-REL and 23.1% for colistin plus IMI in the SmMITT population. The outcomes in the SmMITT population were generally consistent with those in the mMITT population, suggesting that outcomes may be applicable to the real-world use of IMI-REL for treating infections caused by imipenem-nonsusceptible Gram-negative pathogens. (This study has been registered at ClinicalTrials.gov under identifier NCT02452047.).",2020,Day 28 all-cause mortality rates were 9.5% for IMI/REL and 30.0% for colistin plus IMI in mMITT compared with 10.7% for IMI/REL and 23.1% for colistin plus IMI in SmMITT.,"['patients meeting eligibility requirements based on central laboratory susceptibility versus local laboratory susceptibility', 'Patients With Imipenem-Nonsusceptible Bacterial Infections', 'Patients with serious infections caused by imipenem-nonsusceptible, colistin-susceptible, and imipenem/REL-susceptible pathogens']","['IMI/REL plus placebo or colistin plus IMI', 'Imipenem/Cilastatin/Relebactam Versus Colistin Plus Imipenem/Cilastatin', 'primary microbiological modified intent-to-treat population (mMITT', 'imipenem/cilastatin (IMI) combined with relebactam (REL']","['efficacy and safety', 'clinical response and all-cause mortality', 'Favorable clinical response rates', 'favorable overall response', 'mortality rates', 'overall response rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0008777', 'cui_str': 'Cilastatin'}, {'cui': 'C4317244'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",,0.0957439,Day 28 all-cause mortality rates were 9.5% for IMI/REL and 30.0% for colistin plus IMI in mMITT compared with 10.7% for IMI/REL and 23.1% for colistin plus IMI in SmMITT.,"[{'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Boucher', 'Affiliation': 'Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Brown', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Aggrey', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Ireen', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Hee-Koung', 'Initials': 'HK', 'LastName': 'Joeng', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Tipping', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Jiejun', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Young', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Butterton', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Paschke', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA amanda.paschke@merck.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02203-19']
286,32311751,Influence of Antagonist Material on Fatigue and Fracture Resistance of Zirconia Crowns.,"OBJECTIVE
This study investigates the influence of the most commonly used indenter materials on fatigue survival and fracture resistance of zirconia crowns.
MATERIALS AND METHODS
A total of 40 zirconia crowns were prepared using computer-aided design (CAD)/computer-aided manufacturing (CAM) technology: 30 crowns were divided into three experimental groups of 10 specimens and the last 10 specimens acted as the control group. The experimental groups were subjected to chewing simulation with simultaneous thermocycling. Three indenter materials (steatite ceramic, stainless steel, and tungsten carbide) with identical diameter were used to load the specimens. All crowns were then subjected to single load to fracture test in universal testing machine. Load was applied vertically with a crosshead speed of 1 mm/min until failure, and fracture load was recorded.
STATISTICAL ANALYSIS
Normal distribution of data was confirmed using the Shapiro-Wilk test. Descriptive statistics including means and standard deviations were determined for all groups. Differences between groups were tested using Dunnett's test and paired sample t -test.
RESULTS
Chewing simulation for 1.2 million cycles resulted in 100% survival. The highest mean fracture load was recorded for the control group and the lowest one was for the group fatigued with stainless steel indenter. Chewing simulation statistically significantly ( p < 0.05) reduced the mean fracture load of the crowns fatigued with stainless steel and steatite ceramic indenter. However, the mean fracture load for the crowns fatigued with tungsten carbide was not significantly different from that of the control group.
CONCLUSION
Steatite ceramic and stainless steel indenters produced close results and significantly reduced fracture load of zirconia crowns. However, tungsten carbide indenter caused nonsignificant reduction in the fracture load of zirconia crowns.",2020,Chewing simulation statistically significantly ( p < 0.05) reduced the mean fracture load of the crowns fatigued with stainless steel and steatite ceramic indenter.,"['30 crowns', '40 zirconia crowns', 'Zirconia Crowns']","['Antagonist Material', 'computer-aided design (CAD)/computer-aided manufacturing (CAM) technology']","['Fatigue and Fracture Resistance', 'fatigue survival and fracture resistance', 'survival', 'fracture load of zirconia crowns', 'highest mean fracture load', 'mean fracture load']","[{'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}]","[{'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0162516', 'cui_str': 'Computer-Assisted Manufacturing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",30.0,0.0230117,Chewing simulation statistically significantly ( p < 0.05) reduced the mean fracture load of the crowns fatigued with stainless steel and steatite ceramic indenter.,"[{'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Nawafleh', 'Affiliation': 'Department of Applied Dental Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Abdel Raheem', 'Initials': 'AR', 'LastName': 'Bibars', 'Affiliation': 'Department of Applied Dental Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Al Twal', 'Affiliation': 'Department of Applied Dental Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Öchsner', 'Affiliation': 'Faculty of Mechanical Engineering, Esslingen University of Applied Sciences, Esslingen, Germany.'}]",European journal of dentistry,['10.1055/s-0040-1708228']
287,30672067,Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study.,"In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre-randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow-up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post-study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.",2019,Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects.,"['Two hundred and seven received', 'patients who worsen after IVIG withdrawal', 'patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG', '22 subjects who did not achieve', 'chronic inflammatory demyelinating polyneuropathy', '245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12\u2009weeks']","['IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg']","['CIDP stability', 'clinical stability']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0393819', 'cui_str': 'Inflammatory Polyradiculopathy, Chronic'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C2342400', 'cui_str': 'Privigen'}, {'cui': 'C2350568', 'cui_str': 'Prussia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}]","[{'cui': 'C0393819', 'cui_str': 'Inflammatory Polyradiculopathy, Chronic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",9.0,0.0650261,Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects.,"[{'ForeName': 'Orell', 'Initials': 'O', 'LastName': 'Mielke', 'Affiliation': 'CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Cornblath', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'John-Philip', 'Initials': 'JP', 'LastName': 'Lawo', 'Affiliation': 'CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Medical Statistics, Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Ingemar S J', 'Initials': 'ISJ', 'LastName': 'Merkies', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Sobue', 'Affiliation': 'Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Durn', 'Affiliation': 'CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.'}, {'ForeName': 'Amgad', 'Initials': 'A', 'LastName': 'Shebl', 'Affiliation': 'CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.'}, {'ForeName': 'Ivo N', 'Initials': 'IN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the peripheral nervous system : JPNS,['10.1111/jns.12303']
288,30672091,Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies.,"Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].",2019,"No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21).","['population of mainly pre-treated subjects with CIDP', 'immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235', 'CIDP', 'chronic inflammatory demyelinating polyneuropathy (CIDP']","['Intravenous immunoglobulin (IVIG', 'IVIG IgPro10 (Privigen']","['adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score', 'Adverse drug reactions (ADRs) and ADRs/infusion', 'Adjusted INCAT response rate', 'Efficacy and safety', 'INCAT response rate']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0393819', 'cui_str': 'Inflammatory Polyradiculopathy, Chronic'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2746518', 'cui_str': 'Hizentra'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C2342400', 'cui_str': 'Privigen'}]","[{'cui': 'C0270933', 'cui_str': 'Inflammatory neuropathy (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",207.0,0.121427,"No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21).","[{'ForeName': 'Ingemar S J', 'Initials': 'ISJ', 'LastName': 'Merkies', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Ivo N', 'Initials': 'IN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Léger', 'Affiliation': 'National Referral Center for Rare Neuromuscular Diseases, Hôpital Pitié-Salpêtrière and University Paris VI, Paris, France.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Sobue', 'Affiliation': 'Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'John-Philip', 'Initials': 'JP', 'LastName': 'Lawo', 'Affiliation': 'CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.'}, {'ForeName': 'Billie L', 'Initials': 'BL', 'LastName': 'Durn', 'Affiliation': 'CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Cornblath', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'De Bleecker', 'Affiliation': 'Department of Neurology, AZ St-Lucas, Ghent, Belgium.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sommer', 'Affiliation': 'Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Robberecht', 'Affiliation': 'Department of Neurosciences, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Saarela', 'Affiliation': 'Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Kamienowski', 'Affiliation': 'Dolnośląski Szpital Specjalistyczny, Wrocław, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Stelmasiak', 'Affiliation': 'Department of Neurology, Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Tackenberg', 'Affiliation': 'Department of Neurology, Philipps University, Marburg, Germany.'}, {'ForeName': 'Orell', 'Initials': 'O', 'LastName': 'Mielke', 'Affiliation': 'CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the peripheral nervous system : JPNS,['10.1111/jns.12302']
289,32374959,Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke.,"BACKGROUND
In acute ischemic stroke, there is uncertainty regarding the benefit and risk of administering intravenous alteplase before endovascular thrombectomy.
METHODS
We conducted a trial at 41 academic tertiary care centers in China to evaluate endovascular thrombectomy with or without intravenous alteplase in patients with acute ischemic stroke. Patients with acute ischemic stroke from large-vessel occlusion in the anterior circulation were randomly assigned in a 1:1 ratio to undergo endovascular thrombectomy alone (thrombectomy-alone group) or endovascular thrombectomy preceded by intravenous alteplase, at a dose of 0.9 mg per kilogram of body weight, administered within 4.5 hours after symptom onset (combination-therapy group). The primary analysis for noninferiority assessed the between-group difference in the distribution of the modified Rankin scale scores (range, 0 [no symptoms] to 6 [death]) at 90 days on the basis of a lower boundary of the 95% confidence interval of the adjusted common odds ratio equal to or larger than 0.8. We assessed various secondary outcomes, including death and reperfusion of the ischemic area.
RESULTS
Of 1586 patients screened, 656 were enrolled, with 327 patients assigned to the thrombectomy-alone group and 329 assigned to the combination-therapy group. Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P = 0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%). Mortality at 90 days was 17.7% in the thrombectomy-alone group and 18.8% in the combination-therapy group.
CONCLUSIONS
In Chinese patients with acute ischemic stroke from large-vessel occlusion, endovascular thrombectomy alone was noninferior with regard to functional outcome, within a 20% margin of confidence, to endovascular thrombectomy preceded by intravenous alteplase administered within 4.5 hours after symptom onset. (Funded by the Stroke Prevention Project of the National Health Commission of the People's Republic of China and the Wu Jieping Medical Foundation; DIRECT-MT ClinicalTrials.gov number, NCT03469206.).",2020,"Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P = 0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%).","['1586 patients screened, 656 were enrolled, with 327 patients assigned to the thrombectomy-alone group and 329 assigned to the combination-therapy group', 'Patients with acute ischemic stroke from large-vessel occlusion in the anterior circulation', 'Acute Stroke', 'patients with acute ischemic stroke', '41 academic tertiary care centers in China to evaluate', 'Chinese patients with acute ischemic stroke']","['Endovascular Thrombectomy with or without Intravenous Alteplase', 'endovascular thrombectomy with or without intravenous alteplase', 'endovascular thrombectomy alone (thrombectomy-alone group) or endovascular thrombectomy preceded by intravenous alteplase']","['Mortality', 'death and reperfusion of the ischemic area', 'distribution of the modified Rankin scale scores', 'overall successful reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",656.0,0.189257,"Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P = 0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%).","[{'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yongxin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Wenhuo', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jiyue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Shouchun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Congguo', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hongchao', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Xincan', 'Initials': 'X', 'LastName': 'Yue', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lou', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hansheng', 'Initials': 'H', 'LastName': 'Shu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Dianjing', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Kaifu', 'Initials': 'K', 'LastName': 'Ke', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Haicheng', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Huaizhang', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Tianxiao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Zifu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xing', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Qinghai', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Laixing', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yansheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Xihua', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Longde', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Benqiang', 'Initials': 'B', 'LastName': 'Deng', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2001123']
290,31752517,Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease: Results From the EXSCEL Trial.,"BACKGROUND
Recent trials have identified anti-diabetes mellitus agents that lower major adverse cardiovascular event (MACE) rates, although some increase rates of lower-extremity amputation (LEA). Patients with peripheral artery disease (PAD) have greater incidence of diabetes mellitus and risk for LEA, prompting this investigation of clinical outcomes in patients with diabetes mellitus and PAD in the EXSCEL trial (Exenatide Study of Cardiovascular Event Lowering).
METHODS
EXSCEL evaluated the effects of once-weekly exenatide (a GLP-1 [glucagon-like peptide-1] receptor agonist) versus placebo on the rates of the primary composite MACE end point (cardiovascular death, myocardial infarction, or stroke) among patients with type 2 diabetes mellitus. In this post hoc analysis, we assessed the association of baseline PAD with rates of MACE, LEA, and the effects of exenatide versus placebo in patients with and without PAD.
RESULTS
EXSCEL included 2800 patients with PAD (19% of the trial population). These individuals had higher unadjusted and adjusted rates of MACE compared with patients without PAD (13.6% versus 11.4%, respectively) as well as a higher adjusted hazard ratio (adjusted hazard ratio, 1.13 [95% CI, 1.00-1.27]; P =0.047). Patients with PAD had higher all-cause mortality (adjusted hazard ratio 1.38 [95% CI, 1.20-1.60]; P <0.001) and more frequent LEA (adjusted hazard ratio 5.48 [95% CI, 4.16-7.22]; P <0.001). Patients treated with exenatide or placebo had similar rates of MACE and LEA, regardless of PAD status.
CONCLUSIONS
EXSCEL participants with PAD had higher rates of all-cause mortality and LEA compared with those without PAD. There were no differences in MACE or LEA rates with exenatide versus placebo. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01144338.",2019,"Patients with PAD had higher all-cause mortality (adjusted hazard ratio 1.38 [95% CI, 1.20-1.60]; P <0.001) and more frequent LEA (adjusted hazard ratio 5.48 [95% CI, 4.16-7.22]; P <0.001).","['patients with diabetes mellitus and PAD in the EXSCEL trial (Exenatide Study of Cardiovascular Event Lowering', 'Patients with peripheral artery disease (PAD', '2800 patients with PAD (19% of the trial population', 'patients with type 2 diabetes mellitus', 'Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease', 'patients with and without PAD']","['exenatide (a GLP-1 [glucagon-like peptide-1] receptor agonist) versus placebo', 'placebo', 'exenatide or placebo', 'exenatide', 'exenatide versus placebo']","['rates of MACE and LEA, regardless of PAD status', 'rates of the primary composite MACE end point (cardiovascular death, myocardial infarction, or stroke', 'cause mortality', 'frequent LEA', 'MACE or LEA rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C4517680', 'cui_str': 'Two thousand eight hundred'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}]",2800.0,0.527936,"Patients with PAD had higher all-cause mortality (adjusted hazard ratio 1.38 [95% CI, 1.20-1.60]; P <0.001) and more frequent LEA (adjusted hazard ratio 5.48 [95% CI, 4.16-7.22]; P <0.001).","[{'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Badjatiya', 'Affiliation': 'Department of Internal Medicine (A.B.), Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute (P.M., N.J.P., A.F.H., R.J.M., M.R.P. W.S.J.), Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology, University of North Carolina School of Medicine, Chapel Hill (J.B.B.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD (B.K.).'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': ''}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute (P.M., N.J.P., A.F.H., R.J.M., M.R.P. W.S.J.), Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow (N.S.).'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology, and Metabolism, University of Oxford, United Kingdom (R.R.H.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute (P.M., N.J.P., A.F.H., R.J.M., M.R.P. W.S.J.), Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute (P.M., N.J.P., A.F.H., R.J.M., M.R.P. W.S.J.), Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute (P.M., N.J.P., A.F.H., R.J.M., M.R.P. W.S.J.), Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke Clinical Research Institute (P.M., N.J.P., A.F.H., R.J.M., M.R.P. W.S.J.), Duke University School of Medicine, Durham, NC.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008018']
291,31270967,Intravenous iron delivers a sustained (8-week) lowering of pulmonary artery pressure during exercise in healthy older humans.,"In older individuals, pulmonary artery pressure rises markedly during exercise, probably due in part to increased pulmonary vascular resistance and in part to an increase in left-heart filling pressure. Older individuals also show more marked pulmonary vascular response to hypoxia at rest. Treatment with intravenous iron reduces the rise in pulmonary artery pressure observed during hypoxia. Here, we test the hypothesis that intravenous iron administration may also attenuate the rise in pulmonary artery pressure with exercise in older individuals. In a randomized double-blind placebo-controlled physiology study in 32 healthy participants aged 50-80 years, we explored the hypothesis that iron administration would deliver a fall in systolic pulmonary artery pressure (SPAP) during moderate cycling exercise (20 min duration; increase in heart rate of 30 min -1 ) and a change in maximal cycling exercise capacity ( V ˙ O 2 m a x ). Participants were studied before, and at 3 h to 8 weeks after, infusion. SPAP was measured using Doppler echocardiography. Iron administration resulted in marked changes in indices of iron homeostasis over 8 weeks, but no significant change in hemoglobin concentration or inflammatory markers. Resting SPAP was also unchanged, but SPAP during exercise was lower by ~3 mmHg in those receiving iron (P < 0.0001). This effect persisted for 8 weeks. Although V ˙ O 2 m a x remained unaffected in the iron-replete healthy participants studied here, this study demonstrates for the first time the ability of intravenous iron supplementation to reduce systolic pulmonary artery pressure during exercise.",2019,"Resting SPAP was also unchanged, but SPAP during exercise was lower by ~3 ","['32 healthy participants aged 50-80\xa0years', 'older individuals', 'healthy older humans', 'Older individuals']","['intravenous iron supplementation', 'Intravenous iron delivers a sustained (8-week) lowering of pulmonary artery pressure during exercise', 'placebo']","['systolic pulmonary artery pressure', 'systolic pulmonary artery pressure (SPAP', 'heart rate of 30\xa0min -1 ) and a change in maximal cycling exercise capacity ( V', 'pulmonary artery pressure', 'hemoglobin concentration or inflammatory markers', 'Resting SPAP', 'pulmonary artery pressure rises', 'indices of iron homeostasis', 'pulmonary vascular resistance', 'SPAP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}]",32.0,0.151895,"Resting SPAP was also unchanged, but SPAP during exercise was lower by ~3 ","[{'ForeName': 'Hung-Yuan', 'Initials': 'HY', 'LastName': 'Cheng', 'Affiliation': 'Department of Physiology, Anatomy & Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Frise', 'Affiliation': 'Department of Physiology, Anatomy & Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'M Kate', 'Initials': 'MK', 'LastName': 'Curtis', 'Affiliation': 'Department of Physiology, Anatomy & Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Bart', 'Affiliation': 'Department of Physiology, Anatomy & Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nayia', 'Initials': 'N', 'LastName': 'Petousi', 'Affiliation': 'Department of Physiology, Anatomy & Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nick P', 'Initials': 'NP', 'LastName': 'Talbot', 'Affiliation': 'Department of Physiology, Anatomy & Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Balanos', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Robbins', 'Affiliation': 'Department of Physiology, Anatomy & Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Dorrington', 'Affiliation': 'Department of Physiology, Anatomy & Genetics, University of Oxford, Oxford, United Kingdom.'}]",Physiological reports,['10.14814/phy2.14164']
292,31279324,Effects of hydrocortisone on autobiographical memory retrieval in patients with posttraumatic stress disorder and borderline personality disorder: the role of childhood trauma.,"In a previous study, we found that patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD) showed better autobiographical memory (AM) retrieval after hydrocortisone administration than after placebo administration. Here we investigate the neural correlates of AM retrieval after hydrocortisone administration in patients with PTSD or BPD. We recruited 78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication). All participants received an oral placebo or 10 mg hydrocortisone in a randomized order before performing an AM task. Neural activity was monitored during the task by functional magnetic resonance imaging. Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake. Multiple regression analysis revealed that Childhood Trauma Questionnaire scores correlated positively with hydrocortisone effects on activation in the anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum. These results suggest that hydrocortisone-induced neural activation pattern during AM retrieval is related to childhood trauma. Previously described effects in the hippocampus, which were absent in the current study, might be related to PTSD caused by trauma in adulthood. The effects of hydrocortisone on brain activation and how these effects are influenced by childhood trauma, trauma in adulthood, and PTSD symptoms should be determined in future studies.",2019,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","['patients with PTSD or BPD', 'patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD', '78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication', 'patients with posttraumatic stress disorder and borderline personality disorder']","['oral placebo', 'hydrocortisone']","['Neural activation', 'autobiographical memory retrieval', 'Childhood Trauma Questionnaire scores', 'autobiographical memory (AM) retrieval', 'anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum', 'brain activation', 'Neural activity', 'neural activation pattern']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",78.0,0.0472001,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany. sophie.metz@charite.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Gärnter', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Golde', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0459-8']
293,32305379,Sensorimotor performance is improved by targeted memory reactivation during a daytime nap in healthy older adults.,"Sensorimotor consolidation occurs during sleep. However, the benefit of sleep-based consolidation decreases with age due to decreased sleep quality and quantity. This study aimed to enhance sensorimotor performance through repetitive delivery of task-based auditory cues during sleep, known as targeted memory reactivation (TMR). Healthy older adults performed a non-dominant arm throwing task before and after a 1 h nap. While napping, half of participants received TMR throughout the hour. Participants who received TMR during sleep demonstrated a greater overall change in throwing accuracy from the start of the first to the end of the second throwing task session. However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task. Findings support the use of TMR during sleep to enhance task-specific sensorimotor performance in healthy older adults despite age-related decreases in sleep quality and quantity. Future research is needed to evaluate the effects of TMR on rehabilitation protocols.",2020,"However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task.","['Healthy older adults', 'healthy older adults']","['task-based auditory cues', 'TMR']",['sleep quality and quantity'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",,0.0188997,"However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task.","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Johnson', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Maryland School of Medicine, 100 Penn Street, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Scharf', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland Medical Center, 827 Linden Ave, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Avelino C', 'Initials': 'AC', 'LastName': 'Verceles', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland Medical Center, 827 Linden Ave, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Westlake', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Maryland School of Medicine, 100 Penn Street, Baltimore, MD, 21201, United States. Electronic address: kwestlake@som.umaryland.edu.'}]",Neuroscience letters,['10.1016/j.neulet.2020.134973']
294,32319673,"Neuronavigation-Guided rTMS for the Treatment of Depressive Patients With Suicidal Ideation: A Double-Blind, Randomized, Sham-Controlled Trial.","During the last decade, the problem of suicide has become more serious in individuals with depression. Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder (MDD). This study aims to investigate the efficacy of magnetic resonance imaging (MRI)-based neuronavigation-guided daily high-dose rTMS for rapidly improving suicidal ideation in treatment-naive patients with MDD. In the present 1-week double-blind study, 42 treatment-naive patients with MDD with suicidal ideation were randomly assigned to the treatment of escitalopram oxalate tablets (10 mg/d) in combination with either active (n = 21) or sham (n = 21) rTMS. The TMS coil was positioned over a specified target location (-44, 40, and 29) in left dorsolateral prefrontal cortex based on MRI data. The severity of suicidal ideation was measured by the Beck Scale for Suicide Ideation (BSI). The 24-item Hamilton Depression Rating Scale (HAMD-24) and Montgomery-Åsberg Depression Rating Scale (MADRS) were utilized to assess the severity of depression. The Wisconsin Card Sorting Test, Continuous Performance Test, and Stroop Color-Word Test were adopted to assess executive function. In contrast to the sham group, the active rTMS group showed a significantly greater BSI score reduction at the third day and the seventh day (P < 0.001). Moreover, the active rTMS group showed a significantly greater HAMD (P < 0.001) and MADRS (P < 0.001) score reduction at the seventh day in comparison to the sham group. The present findings suggested that the neuronavigation-guided high-dose rTMS may be a novel method to rapidly reduce suicidal ideation and mitigate depressive symptoms.",2020,"Moreover, the active rTMS group showed a significantly greater HAMD (p < 0.001) and MADRS (p < 0.001) score reduction at the seventh day in comparison with the sham group.","['major depressive disorder (MDD', '42 treatment-naive MDD patients with suicidal ideation', 'individuals with depression', 'depressive patients with suicidal ideation', 'treatment-naive MDD patients']","['Repetitive transcranial magnetic stimulation (rTMS', 'MRI-based neuronavigation-guided daily high-dose rTMS', 'escitalopram oxalate tablets (10 mg/d) in combination with either active (n = 21) or sham (n = 21) rTMS', 'Neuronavigation-guided rTMS']","['HAMD', 'suicidal ideation', 'severity of suicidal ideation', 'Wisconsin Card Sorting Test (WCST), Continuous Performance Test (CPT) and Stroop Color-Word Test (SCWT', '24-item Hamilton Depression Rating Scale (HAMD-24) and Montgomery-Asberg Depression Rating Scale (MADRS', 'Beck Scale for Suicide Ideation', 'BSI score reduction', 'MADRS', 'suicidal ideation and mitigate depressive symptom']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136207', 'cui_str': 'Frameless Stereotaxy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1170746', 'cui_str': 'Escitalopram oxalate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582675', 'cui_str': 'Stroop neuropsychological screening test'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582614', 'cui_str': 'Beck scale for suicide ideation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",42.0,0.0772028,"Moreover, the active rTMS group showed a significantly greater HAMD (p < 0.001) and MADRS (p < 0.001) score reduction at the seventh day in comparison with the sham group.","[{'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'JianPing', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jinkai', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shangda', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wei', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Desheng', 'Initials': 'D', 'LastName': 'Shang', 'Affiliation': ""Department of Radiology, First Affiliated Hospital, College of Medicine, The Key Laboratory of Mental Disorder's Management of Zhejiang Province, Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1858']
295,32041717,"Safety and Pharmacokinetic Characterization of Nacubactam, a Novel β-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers.","Nacubactam is a novel β-lactamase inhibitor with dual mechanisms of action as an inhibitor of serine β-lactamases (classes A and C and some class D) and an inhibitor of penicillin binding protein 2 in Enterobacteriaceae The safety, tolerability, and pharmacokinetics of intravenous nacubactam were evaluated in single- and multiple-ascending-dose, placebo-controlled studies. Healthy participants received single ascending doses of nacubactam of 50 to 8,000 mg, multiple ascending doses of nacubactam of 1,000 to 4,000 mg every 8 h (q8h) for up to 7 days, or nacubactam of 2,000 mg plus meropenem of 2,000 mg q8h for 6 days after a 3-day lead-in period. Nacubactam was generally well tolerated, with the most frequently reported adverse events (AEs) being mild to moderate complications associated with intravenous access and headache. There was no apparent relationship between drug dose and the pattern, incidence, or severity of AEs. No clinically relevant dose-related trends were observed in laboratory safety test results. No serious AEs, dose-limiting AEs, or deaths were reported. After single or multiple doses, nacubactam pharmacokinetics appeared linear, and exposure increased in an approximately dose-proportional manner across the dose range investigated. Nacubactam was excreted largely unchanged into urine. Coadministration of nacubactam with meropenem did not significantly alter the pharmacokinetics of either drug. These findings support the continued clinical development of nacubactam and demonstrate the suitability of meropenem as a potential β-lactam partner for nacubactam. (The studies described in this paper have been registered at ClinicalTrials.gov under NCT02134834 [single ascending dose study] and NCT02972255 [multiple ascending dose study].).",2020,"No serious AEs, dose-limiting AEs, or deaths were reported.","['Healthy participants received', 'Healthy Volunteers']","['meropenem', 'placebo', 'single ascending doses of nacubactam 50 to 8,000 mg, multiple ascending doses of nacubactam 1,000 to 4,000 mg every 8 hours (q8h) for up to 7 days, or nacubactam 2,000 mg plus meropenem', 'Nacubactam, a Novel β-Lactamase Inhibitor, Alone and in Combination with Meropenem']","['safety, tolerability, and pharmacokinetics of intravenous nacubactam', 'pattern, incidence, or severity of AEs', 'Nacubactam', 'No serious AEs, dose-limiting AEs, or deaths']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0585326', 'cui_str': 'Every eight hours (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0405137,"No serious AEs, dose-limiting AEs, or deaths were reported.","[{'ForeName': 'Navita L', 'Initials': 'NL', 'LastName': 'Mallalieu', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Winter', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Fettner', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Roche Innovation Center, Welwyn, United Kingdom.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Zwanziger', 'Affiliation': 'Roche Innovation Center, Basel, Switzerland.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Attley', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Rodriguez', 'Affiliation': 'Roche Innovation Center, New York, New York, USA.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kano', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Sameeh M', 'Initials': 'SM', 'LastName': 'Salama', 'Affiliation': 'Fedora Pharmaceuticals, Inc., Edmonton, Alberta, Canada.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Bentley', 'Affiliation': 'Roche Innovation Center, Welwyn, United Kingdom.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Geretti', 'Affiliation': 'Roche Innovation Center, Basel, Switzerland anna_maria.geretti@roche.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02229-19']
296,32042166,An electroencephalographic signature predicts antidepressant response in major depression.,"Antidepressants are widely prescribed, but their efficacy relative to placebo is modest, in part because the clinical diagnosis of major depression encompasses biologically heterogeneous conditions. Here, we sought to identify a neurobiological signature of response to antidepressant treatment as compared to placebo. We designed a latent-space machine-learning algorithm tailored for resting-state electroencephalography (EEG) and applied it to data from the largest imaging-coupled, placebo-controlled antidepressant study (n = 309). Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment. This sertraline-predictive EEG signature generalized to two depression samples, wherein it reflected general antidepressant medication responsivity and related differentially to a repetitive transcranial magnetic stimulation treatment outcome. Furthermore, we found that the sertraline resting-state EEG signature indexed prefrontal neural responsivity, as measured by concurrent transcranial magnetic stimulation and EEG. Our findings advance the neurobiological understanding of antidepressant treatment through an EEG-tailored computational model and provide a clinical avenue for personalized treatment of depression.",2020,Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment.,['major depression'],"['placebo', 'latent-space machine-learning algorithm tailored for resting-state electroencephalography (EEG']","['sertraline resting-state EEG signature indexed prefrontal neural responsivity', 'Symptom improvement']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0002045'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.035978,Symptom improvement was robustly predicted in a manner both specific for the antidepressant sertraline (versus placebo) and generalizable across different study sites and EEG equipment.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'School of Automation Science and Engineering, South China University of Technology, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Molly V', 'Initials': 'MV', 'LastName': 'Lucas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Camarin E', 'Initials': 'CE', 'LastName': 'Rolle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, the Netherlands.'}, {'ForeName': 'Carena A', 'Initials': 'CA', 'LastName': 'Cornelssen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Russell T', 'Initials': 'RT', 'LastName': 'Toll', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Hersh M', 'Initials': 'HM', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Monuszko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Trevor L', 'Initials': 'TL', 'LastName': 'Caudle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kamron', 'Initials': 'K', 'LastName': 'Sarhadi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, the Netherlands.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}]",Nature biotechnology,['10.1038/s41587-019-0397-3']
297,31163106,A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease.,"OBJECTIVE
Studies of depressed psychiatric patients have suggested that antidepressant efficacy can be increased by adding eicosapentaenoic acid (EPA), one of the omega-3 fatty acids found in fish oils. The purpose of this study was to determine whether the addition of EPA improves the response to sertraline in depressed patients with or at high risk for coronary heart disease (CHD).
METHODS
Between May 2014 and June 2018, 144 patients with DSM-5 major depressive disorder seen at the Washington University School of Medicine with or at high risk for CHD were randomized to receive either 50 mg/d of sertraline and 2 g/d of EPA or 50 mg/d of sertraline and corn oil placebo capsules for 10 weeks. The Beck Depression Inventory II (BDI-II) was the primary outcome measure.
RESULTS
After 10 weeks of treatment, there were no differences between the arms on the mean baseline-adjusted BDI-II (placebo, 10.3; EPA, 12.1; P = .22), the 17-item Hamilton Depression Rating Scale (placebo, 7.2; EPA, 8.0; P = .40), or the 10-week remission rate (BDI-II score ≤ 8: placebo, 50.6%; EPA, 46.7%; odds ratio = 0.85; 95% CI, 0.43 to 1.68; P = .63).
CONCLUSIONS
Augmentation of sertraline with 2 g/d of EPA for 10 weeks did not result in greater improvement in depressive symptoms compared to sertraline and corn oil placebo in patients with major depressive disorder and CHD or CHD risk factors. Identifying the characteristics of cardiac patients whose depression may benefit from omega-3 and clarifying the pathways linking omega-3 to improvement in depression symptoms are important directions for future research.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02021669; FDA IND registration number: 121107.",2019,"After 10 weeks of treatment, there were no differences between the arms on the mean baseline-adjusted BDI-II (placebo, 10.3; EPA, 12.1; P = .22), the 17-item Hamilton Depression Rating Scale (placebo, 7.2; EPA, 8.0; P = .40), or the 10-week remission rate (BDI-II score ≤ 8: placebo, 50.6%; EPA, 46.7%; odds ratio = 0.85; 95% CI, 0.43 to 1.68; P = .63).
","['patients with major depressive disorder and CHD or CHD risk factors', 'depressed patients with or at high risk for coronary heart disease (CHD', 'depressed psychiatric patients', 'Between May 2014 and June 2018', 'Depressed Patients With or at Risk for Coronary Heart Disease', '144 patients with DSM-5 major depressive disorder seen at the Washington University School of Medicine with or at high risk for CHD']","['sertraline and 2 g/d of EPA or 50 mg/d of sertraline and corn oil placebo', 'sertraline', 'Placebo', 'EPA', 'sertraline and corn oil placebo', 'eicosapentaenoic acid (EPA', 'Omega-3 and Sertraline']","['depressive symptoms', '17-item Hamilton Depression Rating Scale', '10-week remission rate', 'Beck Depression Inventory II (BDI-II']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",144.0,0.516158,"After 10 weeks of treatment, there were no differences between the arms on the mean baseline-adjusted BDI-II (placebo, 10.3; EPA, 12.1; P = .22), the 17-item Hamilton Depression Rating Scale (placebo, 7.2; EPA, 8.0; P = .40), or the 10-week remission rate (BDI-II score ≤ 8: placebo, 50.6%; EPA, 46.7%; odds ratio = 0.85; 95% CI, 0.43 to 1.68; P = .63).
","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': 'Behavioral Medicine Center, Washington University School of Medicine, 4320 Forest Park Ave, Ste 301, St. Louis, MO 63108. carneyr@wustl.edu.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Freedland', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Eugene H', 'Initials': 'EH', 'LastName': 'Rubin', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Rich', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Steinmeyer', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harris', 'Affiliation': 'Department of Internal Medicine, University of South Dakota and OmegaQuant, LLC, Sioux Falls, South Dakota, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12742']
298,32317100,Outcomes of Patients With Coronary Arterial Bifurcation Narrowings Undergoing Provisional 1-Stent Treatment (from the BIONICS Trial).,"Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (p interaction = 0.61). In conclusion, patients with bifurcation lesions treated and a provisional strategy experienced similar outcomes as those with nonbifurcation lesions. RES performed as well as ZES in bifurcation and nonbifurcation lesions.",2020,"In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%.","['Patients With Coronary Arterial Bifurcation Narrowings Undergoing Provisional 1-Stent Treatment (from the BIONICS Trial', 'patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial', '159 patients with angiographic follow-up', 'Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment']",['ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES'],"['rate of target lesion failure', 'Rates of target lesion failure', 'safety and efficacy', 'rate of binary restenosis', 'Procedural success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005549', 'cui_str': 'Bionics'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C2713007', 'cui_str': 'ridaforolimus'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191070', 'cui_str': '686'}]","[{'cui': 'C2713007', 'cui_str': 'ridaforolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1700035', 'cui_str': 'Zotarolimus'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}]",159.0,0.065132,"In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%.","[{'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Konigstein', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Tel-Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Love', 'Affiliation': 'University of Manitoba, St. Boniface General Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Banai', 'Affiliation': 'Tel-Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Golomb', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gidon Y', 'Initials': 'GY', 'LastName': 'Perlman', 'Affiliation': 'Hadassah Hebrew University Medical Center, Jerusalem, Israel; Medinol Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Melek Ozgu', 'Initials': 'MO', 'LastName': 'Ozan', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gstone@crf.org.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.04.002']
299,32312065,Early enteral feeding on esophageal cancer patients after esophageal resection and reconstruction.,"BACKGROUND
In patients under esophagectomy, early postoperative oral feeding has traditionally been contraindicated to minimize the risk of anastomotic leaks. Because early oral feeding preserves the integrity and function of gut mucosa, the aim of this study was to investigate the impact of postoperative early oral feeding on esophagectomy.
METHODS
Between Oct 2013 and Jan 2016, 41 consecutive patients with esophageal carcinoma (stages I- III), who had undergone minimally invasive Ivor-Lewis surgery, were enrolled in this study. The patients were randomly arranged into the early oral feeding (EOF) group (21 cases) and the simple tube feeding (STF) group (20 cases). The nutritional goal for both groups was 25 kcal/(kg·day). The patients in the EOF group were tube-fed with enteral nutrition and orally fed with 5% glucose in normal saline during the first 4 postoperative days, after that the patients were placed on a liquid diet. The patients in the STF group were postoperatively tube-fed with enteral nutrition for 7 days before being switched to liquid diet. The length of the postoperative hospital stay, rate of perioperative complications, and overall mortality were recorded. Preoperative and postoperative levels of serum albumin (ALB), prealbumin (PA), transferrin (TP), and C reactive protein (CRP) were also monitored.
RESULTS
There were no significant differences of the incidence of postoperative complications and overall mortality between the EOF group and the STF group, but the duration of hospital stay, interval until the first liquid food, and time of ambulation in the EOF group were lower than those of the STF group (P<0.05). EOF patients also showed significantly lower CRP levels compared with the STF group (P<0.05).
CONCLUSIONS
EOF might reduce the duration of hospital stays and CRP levels in esophageal cancer patients who underwent esophagectomy while the mortality and complications were not affected.",2020,"There were no significant differences of the incidence of postoperative complications and overall mortality between the EOF group and the STF group, but the duration of hospital stay, interval until the first liquid food, and time of ambulation in the EOF group were lower than those of the STF group (P<0.05).","['Between Oct 2013 and Jan 2016, 41 consecutive patients with esophageal carcinoma (stages I- III), who had undergone minimally invasive Ivor-Lewis surgery', 'esophageal cancer patients', 'esophageal cancer patients after esophageal resection and reconstruction']","['enteral nutrition', 'simple tube feeding (STF', 'enteral nutrition and orally fed with 5% glucose in normal saline', 'STF', 'early oral feeding (EOF']","['length of the postoperative hospital stay, rate of perioperative complications, and overall mortality', 'incidence of postoperative complications and overall mortality', 'CRP levels', 'duration of hospital stay, interval until the first liquid food, and time of ambulation', 'duration of hospital stays and CRP levels', 'Preoperative and postoperative levels of serum albumin (ALB), prealbumin (PA), transferrin (TP), and C reactive protein (CRP']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152018', 'cui_str': 'Carcinoma of esophagus'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0432292', 'cui_str': 'Familial expansile osteolysis'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}]",41.0,0.0165861,"There were no significant differences of the incidence of postoperative complications and overall mortality between the EOF group and the STF group, but the duration of hospital stay, interval until the first liquid food, and time of ambulation in the EOF group were lower than those of the STF group (P<0.05).","[{'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': ""Guangdong Key Lab for Diagnosis & Treatment of Emerging Infectious Diseases, Department of Thoracic Surgery, Shenzhen Third People' s Hospital, Shenzhen 518112, China.""}, {'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': ""Department of Thoracic Surgery, Shenzhen Third People' s Hospital, Shenzhen 518112, China.""}, {'ForeName': 'Pilai', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': ""Department of Thoracic Surgery, Shenzhen Third People' s Hospital, Shenzhen 518112, China.""}, {'ForeName': 'Qinlang', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': ""Department of Thoracic Surgery, Shenzhen Third People' s Hospital, Shenzhen 518112, China.""}, {'ForeName': 'Hanwei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Shenzhen Third People' s Hospital, Shenzhen 518112, China.""}, {'ForeName': 'Renliang', 'Initials': 'R', 'LastName': 'He', 'Affiliation': ""Department of Thoracic Surgery, Shenzhen Third People' s Hospital, Shenzhen 518112, China.""}, {'ForeName': 'Mingwen', 'Initials': 'M', 'LastName': 'Bao', 'Affiliation': ""Department of Ultrasonic Diagnosis, Shenzhen Third People' s Hospital, Shenzhen 518112, China.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Qiao', 'Affiliation': ""Department of Thoracic Surgery, Shenzhen Third People' s Hospital, Shenzhen 518112, China. szqiaokun@163.com.""}]",Annals of palliative medicine,['10.21037/apm.2020.04.13']
300,28392237,"Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial.","BACKGROUND
Respiratory virus infection is a common cause of hospitalisation in adults. Rapid point-of-care testing (POCT) for respiratory viruses might improve clinical care by reducing unnecessary antibiotic use, shortening length of hospital stay, improving influenza detection and treatment, and rationalising isolation facility use; however, insufficient evidence exists to support its use over standard clinical care. We aimed to assess the effect of routine POCT on a broad range of clinical outcomes including antibiotic use.
METHODS
In this pragmatic, parallel-group, open-label, randomised controlled trial, we enrolled adults (aged ≥18 years) within 24 h of presenting to the emergency department or acute medical unit of a large UK hospital with acute respiratory illness or fever higher than 37·5°C (≤7 days duration), or both, over two winter seasons. Patients were randomly assigned (1:1), via an internet-based allocation sequence with random permuted blocks, to have a molecular POC test for respiratory viruses or routine clinical care. The primary outcome was the proportion of patients who received antibiotics while hospitalised (up to 30 days). Secondary outcomes included duration of antibiotics, proportion of patients receiving single doses or brief courses of antibiotics, length of stay, antiviral use, isolation facility use, and safety. Analysis was by modified intention to treat, excluding patients who declined intervention or were withdrawn for protocol violations. This study is registered with ISRCTN, number 90211642, and has been completed.
FINDINGS
Between Jan 15, 2015, and April 30, 2015, and between Oct 1, 2015, and April 30, 2016, we enrolled 720 patients (362 assigned to POCT and 358 to routine care). Six patients withdrew or had protocol violations. 301 (84%) of 360 patients in the POCT group received antibiotics compared with 294 (83%) of 354 controls (difference 0·6%, 95% CI -4·9 to 6·0; p=0·84). Mean duration of antibiotics did not differ between groups (7·2 days [SD 5·1] in the POCT group vs 7·7 days [4·9] in the control group; difference -0·4, 95% CI -1·2 to 0·4; p=0·32). 50 (17%) of 301 patients treated with antibiotics in the POCT group received single doses or brief courses of antibiotics (<48 h) compared with 26 (9%) of 294 patients in the control group (difference 7·8%, 95% CI 2·5 to 13·1; p=0·0047; number needed to test=13). Mean length of stay was shorter in the POCT group (5·7 days [SD 6·3]) than in the control group (6·8 days [7·7]; difference -1·1, 95% CI -2·2 to -0·3; p=0·0443). Appropriate antiviral treatment of influenza-positive patients was more common in the POCT group (52 [91%] of 57 patients) than in the control group (24 [65%] of 37 patients; difference 26·4%, 95% CI 9·6 to 43·2; p=0·0026; number needed to test=4). We found no differences in adverse outcomes between the groups (77 [21%] of 360 patients in the POCT group vs 88 [25%] of 354 patients in the control group; -3·5%, -9·7 to 2·7; p=0·29).
INTERPRETATION
Routine use of molecular POCT for respiratory viruses did not reduce the proportion of patients treated with antibiotics. However, the primary outcome measure failed to capture differences in antibiotic use because many patients were started on antibiotics before the results of POCT could be made available. Although POCT was not associated with a reduction in the duration of antibiotics overall, more patients in the POCT group received single doses or brief courses of antibiotics than did patients in the control group. POCT was also associated with a reduced length of stay and improved influenza detection and antiviral use, and appeared to be safe.
FUNDING
University of Southampton.",2017,"We found no differences in adverse outcomes between the groups (77 [21%] of 360 patients in the POCT group vs 88 [25%] of 354 patients in the control group; -3·5%, -9·7 to 2·7; p=0·29).
","['adults presenting to hospital with acute respiratory illness (ResPOC', 'Between Jan 15, 2015, and April 30, 2015, and between Oct 1, 2015, and April 30, 2016', '720 patients (362 assigned to POCT and 358 to routine care', 'Six patients withdrew or had protocol violations', 'enrolled adults (aged ≥18 years) within 24 h of presenting to the emergency department or acute medical unit of a large UK hospital with acute respiratory illness or fever higher than 37·5°C (≤7 days duration), or both, over two winter seasons', 'adults']","['Rapid point-of-care testing (POCT', 'POCT', 'Routine molecular point-of-care testing', 'routine POCT']","['adverse outcomes', 'proportion of patients who received antibiotics while hospitalised', 'duration of antibiotics overall', 'duration of antibiotics, proportion of patients receiving single doses or brief courses of antibiotics, length of stay, antiviral use, isolation facility use, and safety', 'Mean duration of antibiotics', 'Mean length of stay', 'reduced length of stay and improved influenza detection and antiviral use']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2717465', 'cui_str': 'HAD protocol'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1319069', 'cui_str': 'Point-of-Care Testing'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}]",720.0,0.178594,"We found no differences in adverse outcomes between the groups (77 [21%] of 360 patients in the POCT group vs 88 [25%] of 354 patients in the control group; -3·5%, -9·7 to 2·7; p=0·29).
","[{'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Brendish', 'Affiliation': 'NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ahalya K', 'Initials': 'AK', 'LastName': 'Malachira', 'Affiliation': 'Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Armstrong', 'Affiliation': 'Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Houghton', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Aitken', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Nyimbili', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Ewings', 'Affiliation': 'Southampton Statistical Sciences Research Institute, University of Southampton, Southampton, UK.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Lillie', 'Affiliation': 'Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Tristan W', 'Initials': 'TW', 'LastName': 'Clark', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK. Electronic address: T.W.Clark@soton.ac.uk.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(17)30120-0']
301,30153737,A Pilot Clinical Trial of Smoking Cessation Services Implemented in the Workplace for Service Industry Employees.,"PURPOSE
Evaluate the feasibility and preliminary efficacy of implementing evidence-based tobacco treatment at the workplace for service industry employees.
DESIGN
Randomized trial using 6 paired worksites (3 test and 3 delayed intervention control sites).
SETTING
US Northeast city.
PARTICIPANTS
Employees were recruited from university food service settings.
INTERVENTION
Comprehensive smoking treatment was provided at the workplace including individual counseling, free pharmacotherapy (dual nicotine replacement therapy or varenicline), and 5 weeks of contingency management that reinforced abstinence or reductions in smoking to encourage progress toward quitting.
MEASURES
Primary measures included a smoking status survey administered at the end of treatment at the test sites and before treatment began at the delayed intervention control sites.
ANALYSIS
Analyses compared rates of quit attempts and successful abstinence for at least 24 hours between the test and delayed intervention control sites.
RESULTS
Twenty-five employees were enrolled in treatment. The majority were single (12/25), black (16/25), and reported their educational attainment as high school or less (18/25). Employees in the test (vs delayed intervention control) sites reported higher rates of quit attempts (66.7% vs 12.5%, P = .02) and success quitting for at least 24 hours (53.3% vs 12.5%, P = .08). Participants rated the treatment as very helpful overall.
CONCLUSION
Findings support the feasibility and efficacy of providing workplace-based smoking cessation services and may inform strategies to increase access to treatment.",2019,"Employees in the test (vs delayed intervention control) sites reported higher rates of quit attempts (66.7% vs 12.5%, P = .02) and success quitting for at least 24 hours (53.3% vs 12.5%, P = .08).","['Employees were recruited from university food service settings', 'Service Industry Employees', 'US Northeast city', '6 paired worksites (3 test and 3 delayed intervention control sites', 'Twenty-five employees were enrolled in treatment']","['implementing evidence-based tobacco treatment', 'Comprehensive smoking treatment was provided at the workplace including individual counseling, free pharmacotherapy (dual nicotine replacement therapy or varenicline']","['rates of quit attempts', 'smoking status survey administered at the end of treatment at the test sites and before treatment began at the delayed intervention control sites', 'success quitting', 'rates of quit attempts and successful abstinence']","[{'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0016490', 'cui_str': 'Food Services'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",25.0,0.021216,"Employees in the test (vs delayed intervention control) sites reported higher rates of quit attempts (66.7% vs 12.5%, P = .02) and success quitting for at least 24 hours (53.3% vs 12.5%, P = .08).","[{'ForeName': 'Krysten W', 'Initials': 'KW', 'LastName': 'Bold', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kimmel', 'Affiliation': '2 Being Well at Yale, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Tess H', 'Initials': 'TH', 'LastName': 'Hanrahan', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Romano', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Alana M', 'Initials': 'AM', 'LastName': 'Rojewski', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Fucito', 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': '1 Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117118795987']
302,32305492,Probiotics and fructo-oligosaccharide intervention modulate the microbiota-gut brain axis to improve autism spectrum reducing also the hyper-serotonergic state and the dopamine metabolism disorder.,"The prevalence of autism spectrum disorders (ASD) is increasing, but its etiology remains elusive and hence an effective treatment is not available. Previous research conducted on animal models suggests that microbiota-gut-brain axis may contribute to ASD pathology and more human research is needed. This study was divided into two stages,.At the discovery stage, we compared the differences in gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters (using UHPLC-MS/MS) of 26 children with ASD and 24 normal children. All 26 children with ASD participated in the intervention stage, and we measured the gut microbiota profiles, SCFAs and neurotransmitters before and after probiotics + FOS (n = 16) or placebo supplementation (n = 10). We found that gut microbiota was in a state of dysbiosis and significantly lower levels of Bifidobacteriales and Bifidobacterium longum were observed at the discovery stage in children with ASD. An increase in beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium) emerged after probiotics + FOS intervention, with significant reduction in the severity of autism and gastrointestinal symptoms. Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD. Interestingly, the above SCFAs in children with autism significantly elevated after probiotics + FOS intervention and approached those in the control group. In addition, our data demonstrated that decreased serotonin and increased homovanillic acid emerged after probiotics + FOS intervention. However, the above-mentioned changes did not appear in the placebo group for ASD children. Probiotics + FOS intervention can modulate gut microbiota, SCFAs and serotonin in association with improved ASD symptoms, including a hyper-serotonergic state and dopamine metabolism disorder.",2020,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","['26 children with ASD', '26 children with ASD and 24 normal children', 'autism', 'autism spectrum disorders (ASD', 'children with ASD']","['Probiotics and fructo-oligosaccharide intervention', 'placebo supplementation', 'Probiotics\u2009+\u2009FOS intervention', 'placebo']","['gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters', 'hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid', 'severity of autism and gastrointestinal symptoms', 'acetic acid, propionic acid and butyric acid', 'homovanillic acid', 'beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0087140', 'cui_str': 'v-fos Oncogenes'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0024868', 'cui_str': 'Chromatography, Gas-Mass Spectrometry'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019903', 'cui_str': 'Homovanillic acid'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C0006523', 'cui_str': 'Butanoic Acids'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C1037103', 'cui_str': 'Bifidobacteriales'}, {'cui': 'C1564227', 'cui_str': 'Longum'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}]",26.0,0.0229384,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China; State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: wangyingying67@163.com.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 754520623@qq.com.""}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'College of Life Science, Qilu Normal University, Jinan, Shandong, China. Electronic address: microbiota@foxmail.com.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Zhao', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: jnzhaodongmei@163.com.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China. Electronic address: binchen23@163.com.""}, {'ForeName': 'Guo-Qing', 'Initials': 'GQ', 'LastName': 'Zhang', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: gqzhang@picb.ac.cn.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Shenzhen Institute of Synthetic Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China; CAS Key Laboratory of Quantitative Engineering Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China. Electronic address: shuo.chen1@siat.ac.cn.'}, {'ForeName': 'Rui-Fang', 'Initials': 'RF', 'LastName': 'Cao', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: caoruifang@picb.ac.cn.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: yuhan_1991@163.com.""}, {'ForeName': 'Chang-Ying', 'Initials': 'CY', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1163310981@qq.com.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1295163749@qq.com.""}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Ge', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1305358934@qq.com.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: liuyi-ly@126.com.""}, {'ForeName': 'Le-Hai', 'Initials': 'LH', 'LastName': 'Zhang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: zlh6813@126.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: hw_1@sdu.edu.cn.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China; Microbiome Research Center, Shandong Institutes for Food and Drug Control, Shandong Institute of Industrial Technology for Health Sciences and Precision Medicine, Jinan, Shandong, China. Electronic address: microbiome@foxmail.com.""}, {'ForeName': 'Zhong-Tao', 'Initials': 'ZT', 'LastName': 'Gai', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: gzt@etyy.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.104784']
303,32306296,Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.,"INTRODUCTION
The safety and efficacy of exenatide once weekly (EQW) is overall well established. EQW is primarily renally eliminated. In this study, the efficacy and renal and gastrointestinal tolerability of EQW were summarised in participants with type 2 diabetes and chronic kidney disease stage 3 (CKD3; moderate renal impairment; estimated glomerular filtration rate [eGFR] ≥ 30 to < 60 mL/min/1.73 m 2 ) or CKD stage 2 (CKD2; mild renal impairment; eGFR ≥ 60 to < 90 mL/min/1.73 m 2 ).
METHODS
Data on participants with type 2 diabetes and baseline CKD3 or CKD2 from eight phase 3, double-blind or open-label studies with 26- or 28-week controlled treatment periods were pooled. Participants received EQW or a placebo/non-glucagon-like peptide-1 receptor agonist comparator (sitagliptin, metformin, pioglitazone, dapagliflozin and insulin).
RESULTS
Participants with baseline CKD3 (N = 182) or CKD2 (N = 772) receiving EQW differed in a number of baseline characteristics, such as age < 65 years, race, mean body mass index and mean type 2 diabetes duration, whereas mean blood pressure and glycated haemoglobin (HbA 1c ) were similar. Mean reductions in HbA 1c , body weight and systolic blood pressure from baseline to week 26/28 in participants receiving EQW were similar between the CKD subgroups. The proportions of participants (CKD3 and CKD2) with any adverse event (AE) were 81% and 72%, respectively, for EQW and 74% and 68%, respectively, for all comparators; those for serious AEs were 2.7% and 3.4%, respectively, for EQW and 6% and 5%, respectively, for all comparators. Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar. There were no dehydration events; one participant in each treatment group had a serious AE of acute kidney injury (EQW with CKD3, n = 1; pioglitazone with CKD2, n = 1).
CONCLUSION
Exenatide once weekly was well tolerated and demonstrated similar efficacy in participants with type 2 diabetes with mild and moderate renal impairment.
TRIAL REGISTRATION
ClinicalTrials.gov identifiers: NCT00637273, NCT00676338, NCT02229383, NCT02229396, NCT00641056, NCT01652729, NCT00935532, NCT01003184.",2020,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","['Participants with baseline', 'participants with type 2 diabetes and chronic kidney disease stage 3 (CKD3; moderate renal impairment; estimated glomerular filtration rate [eGFR]\u2009≥\u200930 to\u2009<\u200960\xa0mL', 'participants with type 2 diabetes and', 'participants with type 2 diabetes with mild and moderate renal impairment', 'Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease']","['EQW', 'exenatide', 'pioglitazone', 'Exenatide', 'CKD3', 'EQW or a placebo/non-glucagon-like peptide-1 receptor agonist comparator (sitagliptin, metformin, pioglitazone, dapagliflozin and insulin']","['Safety and Efficacy', 'mean blood pressure and glycated haemoglobin (HbA 1c ', 'safety and efficacy', 'nausea and vomiting', 'Gastrointestinal AE rates', 'efficacy and renal and gastrointestinal tolerability', 'adverse event (AE', 'serious AE of acute kidney injury', 'Mean reductions in HbA 1c , body weight and systolic blood pressure']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.191815,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': '""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania. cristian.guja@b.astral.ro.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frías', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Suchower', 'Affiliation': 'Kelly Services, Gaithersburg, MD, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Marr', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00815-z']
304,32320002,How oro-sensory exposure and eating rate affect satiation and associated endocrine responses-a randomized trial.,"BACKGROUND
Longer oral processing decreases food intake. This can be attributed to greater oro-sensory exposure (OSE) and a lower eating rate (ER). How these factors contribute to food intake, and the underlying physiological mechanisms, remain unclear.
OBJECTIVES
We aimed to determine the independent and simultaneous effects of OSE and ER on satiation and associated endocrine responses.
METHODS
Forty participants in study 1 [mean ± SD age: 24 ± 4 y; BMI (in kg/m2): 22 ± 2] and 20 in study 2 (mean ± SD age: 23 ± 3 y; BMI: 23 ± 2) participated in a 2 × 2 randomized trial. In both studies, participants ate chocolate custard with added caramel sauce (low OSE) or caramel fudge (high OSE) and with short (fast ER) or long breaks (slow ER) in between bites, until fullness. In study 2, endocrine responses were measured during the meal.
RESULTS
In study 1, participants ate (mean ± SEM) 42 ± 15 g less in the slow- than in the fast-ER condition, only within the high-OSE condition (P = 0.04). In study 2, participants ate 66 ± 21 g less in the high- than in the low-OSE condition and there were no intake differences between slow and fast ER (P = 0.35). Eight minutes after starting to eat, insulin concentrations increased by 42%-65% in all treatments compared with the control. At the end of the meal, insulin concentrations were 81% higher in the high-OSE, slow-ER than in the low-OSE, fast-ER condition (P = 0.049). Pancreatic polypeptide (PP) increased by 62%, 5 min after meal onset in the low-OSE, fast-ER condition (P = 0.005). Ghrelin concentrations did not change.
CONCLUSIONS
Greater OSE increases insulin responsiveness. In contrast, PP responses are stronger when OSE is reduced and ER is fast. Insulin and PP responses may mediate the independent effects of OSE and ER on food intake. These may be beneficial eating strategies, particularly for type 2 diabetic patients, to control food intake and maintain glucose homeostasis.This trial was registered at trialregister.nl as NL6544.",2020,"Eight minutes after starting to eat, insulin concentrations increased by 42%-65% in all treatments compared with the control.","['participants ate (mean\xa0±\xa0SEM) 42\xa0±\xa015 g less in the slow- than in the fast-ER condition, only within the high-OSE condition (P\xa0=\xa00.04', 'SD age: 24\xa0±\xa04\xa0y', 'Forty participants in study 1 [mean\xa0±', ' BMI: 23\xa0±\xa02) participated in a 2\xa0×\xa02 randomized trial']","['chocolate custard with added caramel sauce (low OSE) or caramel fudge (high OSE) and with short (fast ER) or long breaks (slow ER', 'OSE', 'OSE and ER']","['Ghrelin concentrations', 'insulin concentrations', 'BMI', 'eating rate (ER', 'Insulin and PP responses', 'OSE increases insulin responsiveness', 'Pancreatic polypeptide (PP']","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4517407', 'cui_str': '0.04'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0453512', 'cui_str': 'Custard'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0108509', 'cui_str': 'Caramel'}, {'cui': 'C0453357', 'cui_str': 'Sauce'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0458193', 'cui_str': 'Fudge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]","[{'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic peptide'}]",,0.0776592,"Eight minutes after starting to eat, insulin concentrations increased by 42%-65% in all treatments compared with the control.","[{'ForeName': 'Marlou', 'Initials': 'M', 'LastName': 'Lasschuijt', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Mars', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'de Graaf', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Paul A M', 'Initials': 'PAM', 'LastName': 'Smeets', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa067']
305,32320024,Effect of chicory inulin-type fructan-containing snack bars on the human gut microbiota in low dietary fiber consumers in a randomized crossover trial.,"BACKGROUND
The low intake of dietary fiber compared to recommended amounts has been referred to as the dietary fiber gap. The addition of fiber to snack foods could favorably alter gut microbiota and help individuals meet intake recommendations.
OBJECTIVES
Our objective was to examine the effect of low- and moderate-dose fiber-containing snack bars, comprising mainly chicory root inulin-type fructans (ITF), on gut microbiota in healthy adults with habitual low dietary fiber intake using 16S ribosomal RNA-based approaches.
METHODS
In 2 separate 4-wk, placebo-controlled, double-blind, crossover trials, 50 healthy adults with low dietary fiber intake were randomly assigned to receive isocaloric snack bars of either moderate-dose fiber (7 g/d) or control in Trial 1 (n = 25) or low-dose fiber (3 g/d) or control in Trial 2 (n = 25), with 4-wk washout periods. Fecal microbiota composition and inferred function, fecal SCFA concentration, gastrointestinal (GI) symptoms, dietary intake, and quality of life were measured.
RESULTS
Compared with the control group, the moderate-dose group showed significant differences across multiple microbial taxa, most notably an increased relative abundance of the Bifidobacterium genus from (mean ± SEM) 5.3% ± 5.9% to 18.7% ± 15.0%. With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium. Predictive functional profiling identified changes in predicted function after intake of the moderate- but not the low-dose bar. Fecal SCFAs were affected by time but not treatment. There were no between-group differences in GI symptoms. Importantly, fiber intake increased significantly with the moderate- and low-dose bars.
CONCLUSIONS
In healthy adults, adding 3 or 7 g ITF to snack bars increased Bifidobacterium, a beneficial member of the gut microbial community. The addition of ITF to food products could help reduce the dietary fiber gap prevalent in modern life.This trial was registered at clinicaltrials.gov as NCT03042494.",2020,"With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium.","['healthy adults', '50 healthy adults with low dietary fiber intake', 'healthy adults with habitual low dietary fiber intake using 16S ribosomal RNA-based approaches']","['isocaloric snack bars of either moderate-dose fiber (7 g/d) or control in Trial 1 (n\xa0=\xa025) or low-dose fiber', 'chicory inulin-type fructan-containing snack bars', 'low- and moderate-dose fiber-containing snack bars, comprising mainly chicory root inulin-type fructans (ITF', 'placebo']","['relative abundance', 'Fecal SCFAs', 'fiber intake', 'GI symptoms', 'Fecal microbiota composition and inferred function, fecal SCFA concentration, gastrointestinal (GI) symptoms, dietary intake, and quality of life', 'Bifidobacterium']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0242868', 'cui_str': 'Chicory'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3537684', 'cui_str': 'chicory root extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",50.0,0.151477,"With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium.","[{'ForeName': 'Raylene A', 'Initials': 'RA', 'LastName': 'Reimer', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Soto-Vaca', 'Affiliation': 'General Mills Bell Institute of Health and Nutrition, Golden Valley, MN, USA.'}, {'ForeName': 'Alissa C', 'Initials': 'AC', 'LastName': 'Nicolucci', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Shyamchand', 'Initials': 'S', 'LastName': 'Mayengbam', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Heekuk', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Madsen', 'Affiliation': 'Division of Gastroenterology, Centre of Excellence for Gastrointestinal Inflammation and Immunity Research, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Menon', 'Affiliation': 'General Mills Bell Institute of Health and Nutrition, Golden Valley, MN, USA.'}, {'ForeName': 'Elaine E', 'Initials': 'EE', 'LastName': 'Vaughan', 'Affiliation': 'Sensus BV (Royal Cosun), Roosendaal, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa074']
306,32311455,"Disposition of two highly permeable drugs in the upper gastrointestinal lumen of healthy adults after a standard high-calorie, high-fat meal.","OBJECTIVES
To quantify the presence of two model highly permeable drugs, paracetamol and danazol, in the upper gastrointestinal lumen under conditions simulating the situation after disintegration of immediate release dosage forms administered in bioavailability/bioequivalence studies in the fed state. To understand the drug transfer process from the antral contents through the upper small intestine based on luminal drug data.
METHODS
8 healthy male adult volunteers participated in a randomized, single dose, two-phase, crossover study. After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube. The drugs were administered in solution form (Phase I) and in suspension form (Phase II) with a glass of tap water to the antrum of the stomach, 30 min after the initiation of meal administration. Samples were aspirated from the antrum and the upper small intestine up to 4 hours post drug administration.
RESULTS
Apparent concentrations in the aqueous contents of the antrum were higher than apparent concentrations in the micellar contents of the upper small intestine for paracetamol; the opposite was observed for danazol. Based on total drug amount per volume data in contents of the upper gastrointestinal lumen, the transfer of paracetamol (aqueous solution or suspension) and danazol (aqueous suspension) through the upper small intestine could be described as an apparent first-order process. Transfer of a long-chain triglyceride solution of danazol was highly variable.
CONCLUSIONS
Concentrations in the aqueous/micellar phase of luminal contents and values of parameters controlling the transfer from bulk gastric contents through the upper small intestine after a high-calorie, high-fat meal, were reported for the first time for highly permeable drugs. Data are expected to enhance the development of biorelevant in vitro and physiologically based biopharmaceutics modelling methodologies.",2020,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.",['8 healthy male adult volunteers'],"['paracetamol and danazol', 'danazol', 'paracetamol (aqueous solution or suspension) and danazol (aqueous suspension']",[],"[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]",[],8.0,0.0387024,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105351']
307,32312727,Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial.,"INTRODUCTION
Diabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence.
METHODS AND ANALYSIS
A multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks.
ETHICS AND DISSEMINATION
Ethics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals.
TRIAL REGISTRATION NUMBER
ISRCTN64926597; registered on 6 June 2017.",2020,"Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation.","['patients with a hard-to-heal DFU, with blinded outcome assessment', '447 participants will be randomised (245 participants in phase II and 202 participants in phase III']","['TAU alone', 'hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy']","['index ulcer area', 'healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0085565', 'cui_str': 'Outcome Assessment (Health Care)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",447.0,0.157794,"Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK medsbro@leeds.ac.uk.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Nixon', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Myka', 'Initials': 'M', 'LastName': 'Ransom', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gilberts', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Dewhirst', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McGinnis', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Longo', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Game', 'Affiliation': 'Derby Teaching Hospitals NHS Fundation Trust, Derby, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bojke', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chadwick', 'Affiliation': 'College of Podiatry, London, UK.'}, {'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Chandrasekar', 'Affiliation': 'NHS Blood and Transplant, Liverpool, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chetter', 'Affiliation': 'University of Hull, Hull, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Collier', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Shervanthi', 'Initials': 'S', 'LastName': 'Homer-Vanniasinkam', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Jude', 'Affiliation': 'Tameside General Hospital, Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Leigh', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lomas', 'Affiliation': 'NHS Blood and Transplant, Liverpool, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vowden', 'Affiliation': 'Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sharples', 'Affiliation': 'Department of Medical Statistics, London Schoool of Hygience and Tropical Medicine, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035947']
308,31122493,"Safety and efficacy of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo-controlled trial.","BACKGROUND
Dopamine is a key modulator of striatal function and learning and might improve motor recovery after stroke. Previous small trials of dopamine agonists after stroke provide equivocal evidence of effectiveness on improving motor recovery. We aimed to assess the safety and efficacy of co-careldopa plus routine occupational and physical therapy during early rehabilitation after stroke.
METHODS
This double-blind, multicentre, randomised controlled trial of co-careldopa versus placebo in addition to routine NHS occupational and physical therapy was done at 51 UK NHS acute inpatient stroke rehabilitation services. We recruited patients with new or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 5-42 days before randomisation, who were unable to walk 10 m or more, had a score of less than 7 points on the Rivermead Mobility Index, were expected to need rehabilitation, and were able to access rehabilitation after discharge from hospital. Participants were assigned (1:1) using stratified random blocks to receive 6 weeks of oral co-careldopa or matched placebo in addition to routine NHS physiotherapy and occupational therapy. The initial two doses of co-careldopa were 62·5 mg (50 mg of levodopa and 12·5 mg of carbidopa) and the remaining doses were 125 mg (100 mg of levodopa and 25 mg of carbidopa). Participants were required to take a single oral tablet 45-60 min before physiotherapy or occupational therapy session. The primary outcome was ability to walk independently, defined as a Rivermead Mobility Index score of 7 or more, at 8 weeks. Primary and safety analyses were done in the intention-to-treat population. The trial is registered on the ISRCTN registry, number ISRCTN99643613.
FINDINGS
Between May 30, 2011, and March 28, 2014, of 1574 patients found eligible, 593 (mean age 68·5 years) were randomly assigned to either the co-careldopa group (n=308) or to the placebo group (n=285), on an average 18 days after stroke onset. Primary outcome data were available for all 593 patients. We found no evidence that the ability to walk independently improved with co-careldopa (125 [41%] of 308 patients) compared with placebo (127 [45%] of 285 patients; odds ratio 0·78 [95% CI 0·53-1·15]) at 8 weeks. Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]). Serious adverse events were largely similar between groups. Vomiting during therapy sessions, after taking the study drug, was the most frequent adverse event and was more frequent in the co-careldopa group than the placebo group (19 [6·2%] vs 9 [3·2%]).
INTERPRETATION
Co-careldopa in addition to routine occupational and physical therapy does not seem to improve walking after stroke. Further research might identify subgroups of patients with stroke who could benefit from dopaminergic therapy at different doses or times after stroke with more intensive motor therapy.
FUNDING
Medical Research Council.",2019,Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]).,"['51 UK NHS acute inpatient stroke rehabilitation services', 'patients after stroke (DARS', 'Between May 30, 2011, and March 28, 2014, of 1574 patients found eligible, 593 (mean age 68·5 years', 'patients with new or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 5-42 days before randomisation, who were unable to walk 10 m or more, had a score of less than 7 points on the Rivermead Mobility Index, were expected to need rehabilitation, and were able to access rehabilitation after discharge from hospital']","['oral co-careldopa or matched placebo in addition to routine NHS physiotherapy and occupational therapy', 'placebo', 'single oral tablet 45-60 min before physiotherapy or occupational therapy session', 'co-careldopa', 'routine NHS occupational and physical therapy', 'co-careldopa versus placebo', 'co-careldopa plus routine occupational and physical therapy', 'levodopa and 25 mg of carbidopa', 'levodopa and 12·5 mg of carbidopa']","['Mortality', 'safety and efficacy', 'ability to walk independently improved with co-careldopa', 'ability to walk independently, defined as a Rivermead Mobility Index score', 'Vomiting', 'Serious adverse events', 'Safety and efficacy']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0993159', 'cui_str': 'Oral Tablet'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.5157,Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]).,"[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, University of Oxford, Oxford, UK. Electronic address: gary.ford@ouh.nhs.uk.'}, {'ForeName': 'Bipin B', 'Initials': 'BB', 'LastName': 'Bhakta', 'Affiliation': 'The Academic Department of Rehabilitation Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Cozens', 'Affiliation': 'NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Holloway', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pearn', 'Affiliation': 'The Academic Department of Rehabilitation Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Ruddock', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sackley', 'Affiliation': ""School of Population and Environmental Sciences, Faculty of Life Science and Medicine, King's College London, London, UK.""}, {'ForeName': 'Eirini-Christina', 'Initials': 'EC', 'LastName': 'Saloniki', 'Affiliation': 'Centre for Health Services Studies and Personal Social Services Research Unit, University of Kent, Canterbury, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Santorelli', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Marion F', 'Initials': 'MF', 'LastName': 'Walker', 'Affiliation': 'Rehabilitation and Ageing, Queens Medical Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30147-4']
309,31421635,Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo-control study.,"Increasing evidence supports a rapid antidepressant and antisuicidal effect of a single subanesthetic dose of ketamine infusion for treatment-resistant depression (TRD). Maintaining the initial clinical response after ketamine infusion in TRD is a crucial next-step challenge. D-cycloserine (DCS), a partial agonist of the glycine co-agonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, is potentially effective as a depression augmentation treatment. However, whether DCS maintains the antidepressant and antisuicidal effects of ketamine infusion remains unknown. In all, 32 patients with TRD (17 with major depression and 15 with bipolar depression) who responded to ketamine infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47 ± 4.11 at baseline were randomly divided to 6-week DCS treatment (250 mg for 2 days, 500 mg for 2 days, 750 mg for 3 days, and 1000 mg for 5 weeks) and placebo groups. Depression symptoms were rated at timepoints of dose titration and weekly. During the 6-week treatment, the total scores of HAMD did not differ between the DCS and placebo groups. The results remained consistent when stratified by disorder. A mixed model analysis indicated that the DCS group exhibited lower scores of HAMD item 3 (suicide) compared with the placebo group throughout the follow-up period (p = 0.01). A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group. DCS may be therapeutically beneficial for patients with TRD who responded to ketamine infusion but have a residual suicidal risk.",2019,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"['32 patients with TRD (17 with major depression and 15 with bipolar depression', 'infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47\u2009±\u20094.11 at baseline', 'patients with treatment-resistant depression who responded to low-dose ketamine infusion', 'patients with TRD']","['DCS treatment', 'placebo', 'DCS', 'ketamine', 'D-cycloserine (DCS', 'D-cycloserine']","['total scores of HAMD', 'Depression symptoms', 'HAMD item 3 (suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.143272,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. john.krystal@yale.edu.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. tomsu0402@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0480-y']
310,32308190,Testing the efficacy of and parents' preferences for nutrition labels on children's menus from a full-service chain restaurant: results of an online experiment.,"OBJECTIVE
Test the efficacy and perceived effectiveness of nutrition labels on children's menus from a full-service chain restaurant in an online study.
DESIGN
Using a between-groups experiment, parents were randomised to view children's menus displaying one of five children's nutrition labelling conditions: (i) No Nutrition Information (control); (ii) Calories Only; (iii) Calories + Contextual Statement (CS); (iv) Calories, Sodium + CS; or (v) Calories and Sodium in Traffic Lights + CS. Parents hypothetically ordered up to one entrée, side, beverage and dessert for their child, then rated and ranked all five labelling conditions on the level of perceived effectiveness.
SETTING
Online survey.
PARTICIPANTS
998 parents with a 3-12 year old child.
RESULTS
Parents exposed to menus displaying 'Calories, Sodium + CS' selected significantly fewer calories 'overall' (entrées + side + dessert + beverage) compared to parents exposed to the control condition (-53·1 calories, P < 0·05). Parents selected 'entrees' with significantly fewer calories and lower sodium when exposed to menus with 'Calories + CS' (-24·3 calories, P < 0·05); 'Calories, Sodium + CS' (-25·4 calories, -56·1 mg sodium, P < 0·05 for both); and 'Calories and Sodium in Traffic Lights + CS' (-29·1 calories, -58·6 mg sodium, P < 0·05 for both). Parents exposed to menus with 'Calories, Sodium + CS' and 'Calories and Sodium in Traffic Lights + CS' were more likely to notice and understand nutrition information compared to other nuntrition labelling conditions. Parents perceived the menu with 'Calories and Sodium in Traffic Lights + CS' as most effective (P < 0·05).
CONCLUSIONS
Menus disclosing calories, sodium and a contextual statement increased the proportion of parents who noticed and understood nutrition information, and resulted in parents selecting lower calorie and sodium entrées for their children in the hypothetical purchase task.",2020,"RESULTS
Parents exposed to menus displaying 'Calories, Sodium + CS' selected significantly fewer calories 'overall' (entrées + side + dessert + beverage) compared to parents exposed to the control condition (-53·1 calories, P < 0·05).","['998 parents with a 3-12 year old child', ""children's menus from a full-service chain restaurant in an online study"", ""children's menus from a full-service chain restaurant""]","['Calories + Contextual Statement (CS', 'nutrition labels', 'Nutrition Information (control', 'iv) Calories, Sodium + CS; or (v) Calories and Sodium in Traffic Lights + CS', ""view children's menus displaying one of five children's nutrition labelling conditions: (i"", ""Calories, Sodium + CS' and 'Calories and Sodium in Traffic Lights + CS""]","[""calories 'overall""]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1720755', 'cui_str': 'Child nutrition'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",998.0,0.0175147,"RESULTS
Parents exposed to menus displaying 'Calories, Sodium + CS' selected significantly fewer calories 'overall' (entrées + side + dessert + beverage) compared to parents exposed to the control condition (-53·1 calories, P < 0·05).","[{'ForeName': 'Rachel J L', 'Initials': 'RJL', 'LastName': 'Prowse', 'Affiliation': 'Public Health Ontario, 480 University Ave, Suite 300, Toronto, ONM5G 1V2, Canada.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave West, Waterloo, ONN2L 3G1, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Public Health Ontario, 480 University Ave, Suite 300, Toronto, ONM5G 1V2, Canada.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond St., Toronto, ONM5B 1W8, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave West, Waterloo, ONN2L 3G1, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hobin', 'Affiliation': 'Public Health Ontario, 480 University Ave, Suite 300, Toronto, ONM5G 1V2, Canada.'}]",Public health nutrition,['10.1017/S1368980019004488']
311,24852376,"Effect of nitazoxanide in adults and adolescents with acute uncomplicated influenza: a double-blind, randomised, placebo-controlled, phase 2b/3 trial.","BACKGROUND
Influenza is an important cause of morbidity and mortality worldwide. Treatment options are scarce, and new drugs with novel mechanisms of action are needed. We aimed to assess the efficacy and safety of nitazoxanide, a thiazolide anti-infective, for treatment of acute uncomplicated influenza.
METHODS
We did a double-blind, randomised, placebo-controlled, phase 2b/3 trial in 74 primary care clinics in the USA between Dec 27, 2010, and April 30, 2011. We enrolled participants aged 12-65 years with fever, at least one respiratory symptom, and one constitutional symptom of influenza within 48 h of symptom onset. We randomly assigned participants to receive either nitazoxanide 600 mg, nitazoxanide 300 mg, or placebo twice daily for 5 days, (ratio 1:1:1) and followed them up for 28 days. Randomisation lists were computer generated and done in blocks of three. Sponsor, investigators, study monitors, patients, and laboratory personnel were all masked to treatment allocation in the study. The primary endpoint was the time from first dose to alleviation of symptoms. The primary analysis was by intention-to-treat for participants with influenza infection confirmed by RT-PCR or culture at baseline. This trial is registered with ClinicalTrials.gov, number NCT01227421.
FINDINGS
Of 650 participants screened, 624 (96%) were enrolled. Of these, 212 were randomly assigned to receive placebo twice a day, 201 to receive nitazoxanide 300 mg twice a day, and 211 to receive nitazoxanide 600 mg a day. The median duration of symptoms for participants receiving placebo was 116·7 h (95% CI 108·1-122·1) compared with 95·5 h (84·0-108·0; p=0·0084) for those receiving 600 mg nitazoxanide and 109·1 h (96·1-129·5, p=0·52) for those receiving 300 mg nitazoxanide. Adverse events were similar between the three groups, the most common being headache reported by 24 (11%) of 212 patients enrolled in placebo group, 12 (6%) of 201 patients in the low-dose group, and 17 (8%) of 211 patients in the high-dose group, or diarrhoea, reported by seven (3%) patients in the placebo group, four (2%) patients enrolled in the low-dose group, and 17 (8%) patients in the high-dose group.
INTERPRETATION
Treatment with nitazoxanide 600 mg twice daily for 5 days was associated with a reduction of the duration of symptoms in participants with acute uncomplicated influenza. Further studies are warranted to confirm these findings and to assess efficacy of the drug alone or in combination with existing drugs in seriously ill patients and those at risk of influenza complications.
FUNDING
Romark Laboratories LC.",2014,"Adverse events were similar between the three groups, the most common being headache reported by 24 (11%) of 212 patients enrolled in placebo group, 12 (6%) of 201 patients in the low-dose group, and 17 (8%) of 211 patients in the high-dose group, or diarrhoea, reported by seven (3%) patients in the placebo group, four (2%) patients enrolled in the low-dose group, and 17 (8%) patients in the high-dose group.
","['Of 650 participants screened, 624 (96%) were enrolled', '74 primary care clinics in the USA between Dec 27, 2010, and April 30, 2011', 'enrolled participants aged 12-65 years with fever, at least one respiratory symptom, and one constitutional symptom of influenza within 48 h of symptom onset', 'participants with acute uncomplicated influenza', 'adults and adolescents with acute uncomplicated influenza']","['placebo', 'nitazoxanide 600 mg, nitazoxanide 300 mg, or placebo', 'nitazoxanide']","['diarrhoea', 'Adverse events', 'efficacy and safety', 'time from first dose to alleviation of symptoms', 'median duration of symptoms']","[{'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts (observable entity)'}]",74.0,0.718026,"Adverse events were similar between the three groups, the most common being headache reported by 24 (11%) of 212 patients enrolled in placebo group, 12 (6%) of 201 patients in the low-dose group, and 17 (8%) of 211 patients in the high-dose group, or diarrhoea, reported by seven (3%) patients in the placebo group, four (2%) patients enrolled in the low-dose group, and 17 (8%) patients in the high-dose group.
","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Haffizulla', 'Affiliation': 'Sunrise Medical Research, Lauderdale Lakes, FL, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hartman', 'Affiliation': 'Virginia Research Center, Midlothian, VA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Hoppers', 'Affiliation': 'Clinical Research Solutions, Jackson, TN, USA.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Resnick', 'Affiliation': 'R D Clinical Research, Lake Jackson, TX, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Samudrala', 'Affiliation': 'Clinical Research Solutions, Franklin, TN, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ginocchio', 'Affiliation': 'BARC USA, Lake Success, NY, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bardin', 'Affiliation': 'Romark Laboratories, Tampa, FL, USA.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Rossignol', 'Affiliation': 'Romark Laboratories, Tampa, FL, USA. Electronic address: jrossignol@romark.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(14)70717-0']
312,31411082,Effect of Blood Pressure Control on Long-Term Risk of End-Stage Renal Disease and Death Among Subgroups of Patients With Chronic Kidney Disease.,"Background Our objective was to explore the effect of intensive blood pressure (BP) control on kidney and death outcomes among subgroups of patients with chronic kidney disease divided by baseline proteinuria, glomerular filtration rate, age, and body mass index. Methods and Results We included 840 MDRD (Modification of Diet in Renal Disease) trial and 1067 AASK (African American Study of Kidney Disease and Hypertension) participants. We used Cox models to examine whether the association between intensive BP control and risk of end-stage renal disease (ESRD) or death is modified by baseline proteinuria (≥0.44 versus <0.44 g/g), glomerular filtration rate (≥30 versus <30 mL/min per 1.73 m 2 ), age (≥40 versus <40 years), or body mass index (≥30 versus <30 kg/m 2 ). The median follow-up was 14.9 years. Strict (versus usual) BP control was protective against ESRD (hazard ratio [HR] ESRD , 0.77; 95% CI, 0.64-0.92) among those with proteinuria ≥0.44 g/g but not proteinuria <0.44 g/g. Strict (versus usual) BP control was protective against death (HR death , 0.73; 95% CI, 0.59-0.92) among those with glomerular filtration rate <30 mL/min per 1.73 m 2 but not glomerular filtration rate ≥30 mL/min per 1.73 m 2 (HR death , 0.98; 95% CI, 0.84-1.15). Strict (versus usual) BP control was protective against ESRD among those ≥40 years (HR ESRD , 0.82; 95% CI, 0.71-0.94) but not <40 years. Strict (versus usual) BP control was also protective against ESRD among those with body mass index ≥30 kg/m 2 (HR ESRD , 0.75; 95% CI, 0.61-0.92) but not body mass index <30 kg/m 2 . Conclusions The ESRD and all-cause mortality benefits of intensive BP lowering may not be uniform across all subgroups of patients with chronic kidney disease. But intensive BP lowering was not associated with increased risk of ESRD or death among any subgroups that we examined.",2019,"BP control was protective against death (HR death , 0.73","['840 MDRD (Modification of Diet in Renal Disease) trial and 1067 AASK (African American Study of Kidney Disease and Hypertension) participants', 'Subgroups of Patients With Chronic\xa0Kidney Disease', 'patients with chronic kidney disease', 'subgroups of patients with chronic kidney disease divided by baseline proteinuria, glomerular filtration rate, age, and body mass index']","['intensive blood pressure (BP) control', 'Blood Pressure Control']","['protective against ESRD (hazard ratio [HR', 'protective against death (HR death', 'glomerular filtration rate', 'glomerular filtration rate ≥30', 'intensive BP control and risk of end-stage renal disease (ESRD) or death', 'Long-Term Risk of End-Stage Renal Disease and Death', 'risk of ESRD or death']","[{'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C3839656', 'cui_str': 'Modification of diet in renal disease formula'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",840.0,0.143448,"BP control was protective against death (HR death , 0.73","[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Ku', 'Affiliation': 'Division of Nephrology Department of Medicine University of California San Francisco San Francisco, CA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology Department of Medicine Tufts University Boston Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics University of California, San Francisco San Francisco CA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology and Biostatistics University of California, San Francisco San Francisco CA.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Smogorzewski', 'Affiliation': 'Division of Nephrology and Hypertension Department of Medicine University of Southern California Los Angeles CA.'}, {'ForeName': 'Chi-Yuan', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology Department of Medicine University of California San Francisco San Francisco, CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012749']
313,31423869,Effect of Baseline Kidney Function on the Risk of Recurrent Stroke and on Effects of Intensive Blood Pressure Control in Patients With Previous Lacunar Stroke: A Post Hoc Analysis of the SPS3 Trial (Secondary Prevention of Small Subcortical Strokes).,"Background We conducted a post hoc analysis of the SPS3 (Secondary Prevention of Small Subcortical Strokes) Trial to examine the association of chronic kidney disease (CKD) with recurrent stroke, and to assess whether baseline renal function modifies the effects of intensive systolic blood pressure control in patients with previous stroke. Methods and Results A total of 3020 patients with recent magnetic resonance imaging-defined symptomatic lacunar infarctions were randomized to a systolic blood pressure target of <130 mm Hg versus 130 to 149 mm Hg. Predefined primary outcomes were (all-recurrent) stroke and a composite of stroke, acute myocardial infarction, or all-cause death; secondary outcomes were acute myocardial infarction, all-cause death, and intracerebral hemorrhage individually. Among 3017 patients with baseline estimated glomerular filtration rate measurements, we evaluated, using Cox proportional hazards models, the association of CKD with recurrent stroke and effects of the blood pressure targets on outcomes using baseline estimated glomerular filtration rate both as a categorical and linear variable. Regardless of the randomized treatment, CKD at baseline was significantly associated with an increased risk of the primary cardiovascular composite outcome (hazard ratio, 1.7; 95% CI, 1.4-2.1), and all-recurrent stroke (1.5; 1.1-2.0). However, the effects of the lower systolic blood pressure intervention on the primary outcome were not influenced by baseline CKD status (P for interaction=0.62). Conclusions CKD increases the risk of recurrent stroke by 50% in patients with previous lacunar stroke. We found no definitive evidence that renal dysfunction modifies the effects of systolic blood pressure control in patients with previous stroke. Conclusive evidence for this will require adequately powered studies with moderate-to-advanced CKD. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059306.",2019,"Regardless of the randomized treatment, CKD at baseline was significantly associated with an increased risk of the primary cardiovascular composite outcome (hazard ratio, 1.7; 95% CI, 1.4-2.1), and all-recurrent stroke (1.5; 1.1-2.0).","['3017 patients with baseline estimated', 'patients with previous stroke', '3020 patients with recent magnetic resonance imaging-defined symptomatic lacunar infarctions', 'Patients With Previous Lacunar Stroke']","['systolic blood pressure target of <130\xa0mm', 'Baseline Kidney Function', 'intensive systolic blood pressure control', 'Intensive Blood Pressure Control']","['systolic blood pressure intervention', 'recurrent) stroke and a composite of stroke, acute myocardial infarction, or all-cause death; secondary outcomes were acute myocardial infarction, all-cause death, and intracerebral hemorrhage individually', 'risk of recurrent stroke', 'systolic blood pressure control', 'glomerular filtration rate measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0333559', 'cui_str': 'Infarct, Lacunar'}, {'cui': 'C3178801', 'cui_str': 'Lacunar Syndrome'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",3020.0,0.273342,"Regardless of the randomized treatment, CKD at baseline was significantly associated with an increased risk of the primary cardiovascular composite outcome (hazard ratio, 1.7; 95% CI, 1.4-2.1), and all-recurrent stroke (1.5; 1.1-2.0).","[{'ForeName': 'Adhish', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Division of Nephrology and Hypertension University of Utah Salt Lake City UT.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension University of Utah Salt Lake City UT.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Nephrology and Hypertension University of Utah Salt Lake City UT.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Cho', 'Affiliation': 'Division of Nephrology and Hypertension University of Utah Salt Lake City UT.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Division of Nephrology and Hypertension University of Utah Salt Lake City UT.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013098']
314,30848096,Protein supplementation improves lean body mass in physically active older adults: a randomized placebo-controlled trial.,"BACKGROUND
An inadequate protein intake may offset the muscle protein synthetic response after physical activity, reducing the possible benefits of an active lifestyle for muscle mass. We examined the effects of 12 weeks of daily protein supplementation on lean body mass, muscle strength, and physical performance in physically active older adults with a low habitual protein intake (<1.0 g/kg/day).
METHODS
A randomized double-blinded controlled trial was performed among 116 physically active older adults [age 69 (interquartile range: 67-73) years, 82% male] who were training for a 4 day walking event of 30, 40, or 50 km/day. Participants were randomly allocated to either 31 g of milk protein or iso-caloric placebo supplementation for 12 weeks. Body composition (dual-energy X-ray absorptiometry), strength (isometric leg extension and grip strength), quadriceps contractile function, and physical performance [Short Physical Performance Battery, Timed Up-and-Go test, and cardiorespiratory fitness (Åstrand-Rhyming submaximal exercise test)] were measured at baseline and after 12 weeks. We assessed vitamin D status and markers of muscle damage and renal function in blood and urine samples before and after intervention.
RESULTS
A larger increase in relative lean body mass was observed in the protein vs. placebo group (∆0.93 ± 1.22% vs. ∆0.44 ± 1.40%, P Interaction = 0.046). Absolute and relative fat mass decreased more in the protein group than in the placebo group (∆-0.90 ± 1.22 kg vs. ∆-0.31 ± 1.28 kg, P Interaction = 0.013 and ∆-0.92 ± 1.19% vs. ∆-0.39 ± 1.36%, P Interaction = 0.029, respectively). Strength and contractile function did not change in both groups. Gait speed, chair-rise ability, Timed Up-and-Go, and cardiorespiratory fitness improved in both groups (P < 0.001), but no between-group differences were observed. Serum urea increased in the protein group, whereas no changes were observed in the placebo group (P Interaction < 0.001). No between-group differences were observed for vitamin D status, muscle damage, and renal function markers.
CONCLUSIONS
In physically active older adults with relatively low habitual dietary protein consumption, an improvement in physical performance, an increase in lean body mass, and a decrease in fat mass were observed after walking exercise training. A larger increase in relative lean body mass and larger reduction in fat mass were observed in participants receiving 12 weeks of daily protein supplementation compared with controls, whereas this was not accompanied by differences in improvements between groups in muscle strength and physical performance.",2019,"Gait speed, chair-rise ability, Timed Up-and-Go, and cardiorespiratory fitness improved in both groups (P < 0.001), but no between-group differences were observed.","['116 physically active older adults [age 69 (interquartile range: 67-73) years, 82% male] who were training for a 4\xa0day walking event of 30, 40, or 50\xa0km/day', 'physically active older adults with relatively low habitual dietary protein consumption', 'physically active older adults with a low habitual protein intake (<1.0\xa0g/kg/day', 'physically active older adults']","['31\xa0g of milk protein or iso-caloric placebo supplementation', 'Protein supplementation', 'placebo', 'daily protein supplementation']","['Gait speed, chair-rise ability, Timed Up-and-Go, and cardiorespiratory fitness', 'vitamin D status and markers of muscle damage and renal function in blood and urine samples', 'muscle strength and physical performance', 'Serum urea', 'Strength and contractile function', 'relative lean body mass', 'lean body mass, muscle strength, and physical performance', 'fat mass', 'Absolute and relative fat mass', 'vitamin D status, muscle damage, and renal function markers', 'Body composition (dual-energy X-ray absorptiometry), strength (isometric leg extension and grip strength), quadriceps contractile function, and physical performance [Short Physical Performance Battery, Timed Up-and-Go test, and cardiorespiratory fitness (Åstrand-Rhyming submaximal exercise test', 'lean body mass', 'physical performance']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}]","[{'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2607857'}, {'cui': 'C0856666', 'cui_str': 'Serum urea'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}]",116.0,0.350734,"Gait speed, chair-rise ability, Timed Up-and-Go, and cardiorespiratory fitness improved in both groups (P < 0.001), but no between-group differences were observed.","[{'ForeName': 'Dominique S M', 'Initials': 'DSM', 'LastName': 'Ten Haaf', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, Nijmegen, The Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, Nijmegen, The Netherlands.'}, {'ForeName': 'Coen C W G', 'Initials': 'CCWG', 'LastName': 'Bongers', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, Nijmegen, The Netherlands.'}, {'ForeName': 'Astrid M H', 'Initials': 'AMH', 'LastName': 'Horstman', 'Affiliation': 'FrieslandCampina, Amersfoort, The Netherlands.'}, {'ForeName': 'Silvie', 'Initials': 'S', 'LastName': 'Timmers', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, Nijmegen, The Netherlands.'}, {'ForeName': 'Lisette C P G M', 'Initials': 'LCPGM', 'LastName': 'de Groot', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Maria T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, Nijmegen, The Netherlands.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12394']
315,32273271,A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial.,"OBJECTIVE
The role of U300 glargine insulin for the inpatient management of type 2 diabetes (T2D) has not been determined. We compared the safety and efficacy of glargine U300 versus glargine U100 in noncritically ill patients with T2D.
RESEARCH DESIGN AND METHODS
This prospective, open-label, randomized clinical trial included 176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c 9.5 ± 2.2%), treated with oral agents or insulin before admission. Patients were treated with a basal-bolus regimen with glargine U300 ( n = 92) or glargine U100 ( n = 84) and glulisine before meals. We adjusted insulin daily to a target BG of 70-180 mg/dL. The primary end point was noninferiority in the mean difference in daily BG between groups. The major safety outcome was the occurrence of hypoglycemia.
RESULTS
There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74). There were no differences in the proportion of patients with BG <70 mg/dL (8.7% vs. 9.5%, P > 0.99), but glargine U300 resulted in significantly lower rates of clinically significant hypoglycemia (<54 mg/dL) compared with glargine U100 (0% vs. 6.0%, P = 0.023).
CONCLUSIONS
Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.",2020,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74).","['type 2 diabetes (T2D', 'Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial', '176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c 9.5 ± 2.2%), treated with oral agents or insulin before admission', 'noncritically ill patients with T2D.\nMETHODS']","['Glargine U300 and Glargine U100', 'U300 glargine insulin', 'glargine U300 versus glargine', 'glargine U100', 'glargine U300']","['percentage of readings within target BG', 'safety and efficacy', 'rates of clinically significant hypoglycemia', 'length of stay', 'hospital complications', 'occurrence of hypoglycemia']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",176.0,0.187812,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74).","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Lansang', 'Affiliation': 'The Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Khowaja', 'Affiliation': 'Hennepin County Medical Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'M Agustina', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Migdal', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA geumpie@emory.edu.'}]",Diabetes care,['10.2337/dc19-1940']
316,30371767,Timing of revascularization in patients with transient ST-segment elevation myocardial infarction: a randomized clinical trial.,"Aims
Patients with acute coronary syndrome who present initially with ST-elevation on the electrocardiogram but, subsequently, show complete normalization of the ST-segment and relief of symptoms before reperfusion therapy are referred to as transient ST-segment elevation myocardial infarction (STEMI) and pose a therapeutic challenge. It is unclear what the optimal timing of revascularization is for these patients and whether they should be treated with a STEMI-like or a non-ST-segment elevation myocardial infarction (NSTEMI)-like invasive approach. The aim of the study is to determine the effect of an immediate vs. a delayed invasive strategy on infarct size measured by cardiac magnetic resonance imaging (CMR).
Methods and results
In a randomized clinical trial, 142 patients with transient STEMI with symptoms of any duration were randomized to an immediate (STEMI-like) [0.3 h; interquartile range (IQR) 0.2-0.7 h] or a delayed (NSTEMI-like) invasive strategy (22.7 h; IQR 18.2-27.3 h). Infarct size as percentage of the left ventricular myocardial mass measured by CMR at day four was generally small and not different between the immediate and the delayed invasive group (1.3%; IQR 0.0-3.5% vs. 1.5% IQR 0.0-4.1%, P = 0.48). By intention to treat, there was no difference in major adverse cardiac events (MACE), defined as death, reinfarction, or target vessel revascularization at 30 days (2.9% vs. 2.8%, P = 1.00). However, four additional patients (5.6%) in the delayed invasive strategy required urgent intervention due to signs and symptoms of reinfarction while awaiting angiography.
Conclusion
Overall, infarct size in transient STEMI is small and is not influenced by an immediate or delayed invasive strategy. In addition, short-term MACE was low and not different between the treatment groups.",2019,"By intention to treat, there was no difference in major adverse cardiac events (MACE), defined as death, reinfarction, or target vessel revascularization at 30 days (2.9% vs. 2.8%, P = 1.00).","['Patients with acute coronary syndrome who present initially with ST-elevation on the electrocardiogram but, subsequently, show complete normalization of the ST-segment and relief of symptoms before reperfusion therapy are referred to as transient ST-segment elevation myocardial infarction (STEMI) and pose a therapeutic challenge', '142 patients with transient STEMI with symptoms of any duration', 'patients with transient ST-segment elevation myocardial infarction']",['cardiac magnetic resonance imaging (CMR'],"['Infarct size as percentage of the left ventricular myocardial mass', 'major adverse cardiac events (MACE), defined as death, reinfarction, or target vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",142.0,0.199712,"By intention to treat, there was no difference in major adverse cardiac events (MACE), defined as death, reinfarction, or target vessel revascularization at 30 days (2.9% vs. 2.8%, P = 1.00).","[{'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, VU University, De Boelelaan 1089a, Amsterdam, the Netherlands.'}, {'ForeName': 'Koen M J', 'Initials': 'KMJ', 'LastName': 'Marques', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Yolande E A', 'Initials': 'YEA', 'LastName': 'Appelman', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels J W', 'Initials': 'NJW', 'LastName': 'Verouden', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis P', 'Initials': 'CP', 'LastName': 'Allaart', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Stijn L', 'Initials': 'SL', 'LastName': 'Brinckman', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Rijksstraatweg 1, Blaricum, the Netherlands.'}, {'ForeName': 'Colette E', 'Initials': 'CE', 'LastName': 'Saraber', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Rijksstraatweg 1, Blaricum, the Netherlands.'}, {'ForeName': 'Koos J', 'Initials': 'KJ', 'LastName': 'Plomp', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Rijksstraatweg 1, Blaricum, the Netherlands.'}, {'ForeName': 'Jorik R', 'Initials': 'JR', 'LastName': 'Timmer', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dokter van Heesweg 2, Zwolle, the Netherlands.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dokter van Heesweg 2, Zwolle, the Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Dokter van Heesweg 2, Zwolle, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Molengracht 21, Breda, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Schaap', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Molengracht 21, Breda, the Netherlands.'}, {'ForeName': 'Arno P', 'Initials': 'AP', 'LastName': 'van der Weerdt', 'Affiliation': 'Department of Cardiology, Medical Center Leeuwarden, Henri Dunantweg 2, Leeuwarden, the Netherlands.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, VU University Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.'}]",European heart journal,['10.1093/eurheartj/ehy651']
317,30578883,Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis.,"BACKGROUND
In a recent phase III trial (NCT02020889) 53% of mepolizumab-treated versus 19% of placebo-treated patients with eosinophilic granulomatosis with polyangiitis (EGPA) achieved protocol-defined remission.
OBJECTIVE
We sought to investigate post hoc the clinical benefit of mepolizumab in patients with EGPA using a comprehensive definition of benefit encompassing remission, oral glucocorticoid (OGC) dose reduction, and EGPA relapses.
METHODS
The randomized, placebo-controlled, double-blind, parallel-group trial recruited patients with relapsing/refractory EGPA receiving stable OGCs (prednisolone/prednisone, ≥7.5-50 mg/d) for 4 or more weeks. Patients received 300 mg of subcutaneous mepolizumab or placebo every 4 weeks for 52 weeks. Clinical benefit was defined post hoc as follows: remission at any time (2 definitions used), 50% or greater OGC dose reduction during weeks 48 to 52, or no EGPA relapses. The 2 remission definitions were Birmingham Vasculitis Activity Score of 0 plus OGC dose of 4 mg/d or less (remission 1/clinical benefit 1) or 7.5 mg/d or less (remission 2/clinical benefit 2). Clinical benefit was assessed in all patients and among subgroups with a baseline blood eosinophil count of less than 150 cells/μL, baseline OGC dosage of greater than 20 mg/d, or weight of greater than 85 kg.
RESULTS
With mepolizumab versus placebo, 78% versus 32% of patients experienced clinical benefit 1, and 87% versus 53% of patients experienced clinical benefit 2 (both P < .001). Significantly more patients experienced clinical benefit 1 with mepolizumab versus placebo in the blood eosinophil count less than 150 cells/μL subgroup (72% vs 43%, P = .033) and weight greater than 85 kg subgroup (68% vs 23%, P = .005); in the OGC greater than 20 mg/d subgroup, results were not significant but favored mepolizumab (60% vs 36%, P = .395).
CONCLUSION
When a comprehensive definition of clinical benefit was applied to data from a randomized controlled trial, 78% to 87% of patients with EGPA experienced benefit with mepolizumab.",2019,"Significantly more patients experienced clinical benefit 1 with mepolizumab versus placebo in the blood eosinophil count less than 150 cells/μL subgroup (72% vs 43%, P = .033) and weight greater than 85 kg subgroup (68% vs 23%, P = .005); in the OGC greater than 20 mg/d subgroup, results were not significant but favored mepolizumab (60% vs 36%, P = .395).
","['treated patients with eosinophilic granulomatosis with polyangiitis (EGPA', ' ≥7.5-50\xa0mg/d) for 4 or more weeks', 'all patients and among subgroups with a baseline blood eosinophil count of less than 150\xa0cells/μL, baseline OGC dosage of greater than 20\xa0mg/d, or weight of greater than 85\xa0kg', 'patients with eosinophilic granulomatosis with polyangiitis', 'patients with EGPA using a comprehensive definition of benefit encompassing remission, oral glucocorticoid (OGC) dose reduction, and EGPA relapses', 'patients with relapsing/refractory EGPA receiving stable']","['mepolizumab', 'OGCs (prednisolone/prednisone', 'subcutaneous mepolizumab or placebo', 'placebo']","['Birmingham Vasculitis Activity Score', 'blood eosinophil count']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008728', 'cui_str': 'Allergic Granulomatosis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2609436', 'cui_str': 'Vasculitis (SMQ)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.433684,"Significantly more patients experienced clinical benefit 1 with mepolizumab versus placebo in the blood eosinophil count less than 150 cells/μL subgroup (72% vs 43%, P = .033) and weight greater than 85 kg subgroup (68% vs 23%, P = .005); in the OGC greater than 20 mg/d subgroup, results were not significant but favored mepolizumab (60% vs 36%, P = .395).
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Steinfeld', 'Affiliation': 'Respiratory TAU & Flexible Discovery Unit, GlaxoSmithKline, Philadelphia, Pa.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Bradford', 'Affiliation': 'Respiratory Therapeutic Area, GlaxoSmithKline, Research Triangle Park, NC.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Research and Development, Immuno-Inflammation TAU, Uxbridge, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Mallett', 'Affiliation': 'Research & Development, Statistics, Programming and Data Standards, GlaxoSmithKline, Stockley Park West, Uxbridge, United Kingdom.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Yancey', 'Affiliation': 'Respiratory Therapeutic Area, GlaxoSmithKline, Research Triangle Park, NC.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Akuthota', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of California San Diego, La Jolla, Calif.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Cid', 'Affiliation': ""Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Gleich', 'Affiliation': 'Departments of Dermatology and Medicine, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Paneez', 'Initials': 'P', 'LastName': 'Khoury', 'Affiliation': 'Human Eosinophil Section, Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Langford', 'Affiliation': 'Department of Rheumatic and Immunologic Diseases, Center for Vasculitis Care and Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'Division of Rheumatology, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Moosig', 'Affiliation': 'Rheumazentrum, Schleswig-Holstein Mitte, Neumünster, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Weller', 'Affiliation': 'Divisions of Allergy and Infectious Diseases, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colo. Electronic address: wechslerm@njhealth.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.11.041']
318,32312616,Hydroxychloroquine for colchicine-resistant glucocorticoid-dependent idiopathic recurrent pericarditis: A pilot observational prospective study.,"BACKGROUND
Glucocorticoid (GC)-dependent, colchicine-resistant idiopathic recurrent pericarditis (IRP) remains a clinical challenge. We assessed for the first time the efficacy and safety of hydroxychloroquine (HCQ) in IRP.
METHODS AND RESULTS
This is a post hoc analysis of prospectively collected data of 15 patients with refractory to standard therapy (colchicine plus either GC or anakinra) IRP (≥3 recurrences, disease duration ≥12 months and inability to wean off treatment) treated with HCQ (400 mg/day). These patients were matched 1:1 for age, sex, and treatment type to IRP patients receiving standard-of-care treatment (control group, n = 15). Pericarditis recurrence, the time to 1st flare, the % of patients able to achieve a ≥50% reduction of baseline GC dose and the % reduction of GC dose, were compared between groups. HCQ did not reduce pericarditis recurrence risk as almost all patients (n = 29) but one in the HCQ group (14/15) relapsed during follow-up. However, HCQ treatment was associated with an increased median time of flare-free survival (increase by 4 weeks compared to controls) and reduced hazard ratio for flare in survival analysis (HR = 0.36, 95% CI 0.16-0.77, p = 0.009). HCQ was also associated with a higher proportion of patients obtaining a ≥50% dose reduction of GCs (33.3% vs. 0% in the control group, p = 0.037) and reduced GC dose (HCQ: -43.5% vs. control: -4.5%, p < 0.001). No differences in CRP levels at flare was detected (p = 0.615).
CONCLUSIONS
In this prospective study, HCQ depicted a GC-sparing effect and an increased flare-free survival period in patients with colchicine resistant GC-dependent IRP.",2020,"However, HCQ treatment was associated with an increased median time of flare-free survival (increase by 4 weeks compared to controls) and reduced hazard ratio for flare in survival analysis (HR = 0.36, 95% CI 0.16-0.77, p = 0.009).","['dependent idiopathic recurrent pericarditis', 'patients were matched 1:1 for age, sex, and treatment type to IRP patients receiving standard-of-care treatment (control group, n\xa0=\xa015', 'patients with colchicine resistant GC-dependent IRP', '15 patients with refractory to standard therapy ']","['Glucocorticoid (GC)-dependent, colchicine', 'HCQ', 'colchicine-resistant glucocorticoid', 'colchicine plus either GC or anakinra', 'Hydroxychloroquine', 'IRP', 'hydroxychloroquine (HCQ']","['hazard ratio for flare in survival analysis', 'CRP levels at flare', 'GCs', 'median time of flare-free survival', 'pericarditis recurrence risk', 'Pericarditis recurrence']","[{'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C4707790', 'cui_str': 'Idiopathic recurrent pericarditis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C4707790', 'cui_str': 'Idiopathic recurrent pericarditis'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",15.0,0.0343907,"However, HCQ treatment was associated with an increased median time of flare-free survival (increase by 4 weeks compared to controls) and reduced hazard ratio for flare in survival analysis (HR = 0.36, 95% CI 0.16-0.77, p = 0.009).","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Lazaros', 'Affiliation': '1st Cardiology Clinic, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital, Athens, Greece. Electronic address: glaz35@hotmail.com.'}, {'ForeName': 'Alexios S', 'Initials': 'AS', 'LastName': 'Antonopoulos', 'Affiliation': '1st Cardiology Clinic, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital, Athens, Greece.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Antonatou', 'Affiliation': '2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Skendros', 'Affiliation': 'First Department of Internal Medicine, Democritus University of Thrace, University Hospital of Alexandroupolis, Alexandroupolis, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Ritis', 'Affiliation': 'First Department of Internal Medicine, Democritus University of Thrace, University Hospital of Alexandroupolis, Alexandroupolis, Greece.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Hadziyannis', 'Affiliation': '2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital Athens, Greece.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Lazarou', 'Affiliation': '1st Cardiology Clinic, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Leontsinis', 'Affiliation': '1st Cardiology Clinic, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital, Athens, Greece.'}, {'ForeName': 'Spiros', 'Initials': 'S', 'LastName': 'Simantiris', 'Affiliation': '1st Cardiology Clinic, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital, Athens, Greece.'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Vlachopoulos', 'Affiliation': '1st Cardiology Clinic, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital, Athens, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': '1st Cardiology Clinic, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Vassilopoulos', 'Affiliation': '2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, National and Kapodistrian University of Athens, School of Medicine, Hippokration General Hospital Athens, Greece.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.03.069']
319,30767253,Effects of dapagliflozin vs vildagliptin on cardiometabolic parameters in diabetic patients with coronary artery disease: a randomised study.,"AIMS
Sodium glucose co-transporter-2 inhibitors have been shown to reduce cardiovascular events and heart failure in type 2 diabetic (T2D) patients with high cardiovascular risk. Dipeptidyl peptidase-4 inhibitors showed neutral effects and may increase risk of heart failure. We aimed to compare cardiometabolic effects of dapagliflozin and vildagliptin in T2D patients with coronary artery disease (CAD).
METHODS
Forty-nine T2D patients with CAD were randomly assigned to dapagliflozin (n = 25) or vildagliptin (n = 24) for 6 months in a double-blind fashion. Cardiometabolic parameters were collected at baseline and at the end of treatments.
RESULTS
Mean age was 63.2 ± 7.9 years (female 46.9%). Baseline characteristics did not differ between two groups. At 6 months, HbA 1C significantly decreased in both dapaglifozin and vildagliptin groups (0.6 ± 1.0% vs 0.8 ± 1.4%, P = 0.22, respectively). There was no difference between the changes in lipid profiles. Body mass index decreased in patients receiving dapagliflozin, whereas it increased in those receiving vildagliptin (-1.27 [95% confidence interval -2.01, -0.53] vs 1.72 [0.72, 2.72] kg, P < 0.001). The reduction in systolic blood pressure and high-sensitivity troponin T was observed in the dapagliflozin group (-9.87 [-18.00, -1.15] mmHg and 2.49 [-4.50, -0.47] pg/mL) but not in vildagliptin group (-1.97 [-9.42, 5.48] mmHg and 1.98 [-0.02, 3.97] pg/mL). The mean haemoglobin increased in the dapagliflozin group, whereas the mean platelet volume increased in the vildagliptin group. There was no significant change in the inflammatory markers in both the groups.
CONCLUSIONS
The extraglycaemic effects of dapagliflozin and vildagliptin on cardiometabolic parameters in T2D with CAD were different. The more favourable effects of dapagliflozin compared to vildagliptin may have explained the cardiovascular benefits observed only in sodium glucose co-transporter-2 inhibitors.",2019,"At 6 months, HbA 1C significantly decreased in both dapaglifozin and vildagliptin groups (0.6 ± 1.0% vs 0.8 ± 1.4%, P = 0.22, respectively).","['type 2 diabetic (T2D) patients with high cardiovascular risk', 'T2D with CAD', 'Mean age was 63.2\xa0±\xa07.9\xa0years (female 46.9', 'patients with CAD', 'diabetic patients with coronary artery disease', 'Forty-nine', 'T2D patients with coronary artery disease (CAD']","['dapagliflozin vs vildagliptin', 'Dipeptidyl peptidase-4 inhibitors', 'T2D', 'vildagliptin', 'dapagliflozin', 'dapaglifozin and vildagliptin', 'dapagliflozin and vildagliptin', 'Sodium glucose co-transporter-2 inhibitors']","['Body mass index', 'mean haemoglobin', 'mean platelet volume', 'cardiovascular events and heart failure', 'Cardiometabolic parameters', 'lipid profiles', 'cardiometabolic parameters', 'risk of heart failure', 'systolic blood pressure and high-sensitivity troponin T', 'inflammatory markers']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0200665', 'cui_str': 'Mean Platelet Volume'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}]",49.0,0.0810709,"At 6 months, HbA 1C significantly decreased in both dapaglifozin and vildagliptin groups (0.6 ± 1.0% vs 0.8 ± 1.4%, P = 0.22, respectively).","[{'ForeName': 'Arintaya', 'Initials': 'A', 'LastName': 'Phrommintikul', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Wanwarang', 'Initials': 'W', 'LastName': 'Wongcharoen', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sirinart', 'Initials': 'S', 'LastName': 'Kumfu', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Thidarat', 'Initials': 'T', 'LastName': 'Jaiwongkam', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Siriluck', 'Initials': 'S', 'LastName': 'Gunaparn', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Siriporn', 'Initials': 'S', 'LastName': 'Chattipakorn', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nipon', 'Initials': 'N', 'LastName': 'Chattipakorn', 'Affiliation': 'Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",British journal of clinical pharmacology,['10.1111/bcp.13903']
320,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND
Multiple androgens drive prostate cancer progression and higher pre-treatment levels of androgens, even within the castrate range, have been previously shown to be associated with an improved overall survival (OS) in mCRPC. Docetaxel impairs microtubules, has androgen receptor (AR) inhibitory effects and is used in both the castration resistant and sensitive settings, where androgen dynamics may impact outcome. The present analysis evaluates the association of decline in serum androgen levels (Testosterone (T), Androstenedione (A) and DHEA in docetaxel-treated mCRPC patients with OS.
METHODS
Data from 1050 men treated on CALGB 90401 with docetaxel, prednisone and either bevacizumab or placebo were evaluated. Eligibility required progressive mCRPC and no prior chemotherapy. Pre-treatment, 6 week and progression serum assays for T, A and DHEA were performed via tandem Liquid Chromatography-Mass Spectrometry (LC-MS/MS). Changes in T, A and DHEA levels from baseline to 6 weeks were calculated as the ratio of 6-week over baseline. The proportional hazards model was used to assess the prognostic significance of changes in T, A, and DHEA from baseline to 6 weeks in predicting OS adjusting for known prognostic factors.
RESULTS
Median baseline values for T, A, and, DHEA were 1.0, 13.5, and 8.1 ng/dL respectively while 6 week levels were 0.64, 7.0, and 6.8 ng/dL respectively. Median OS for low testosterone decline is 20.9 months vs 26.3 months for high testosterone decline. In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001). Decline in A and DHEA were not significant predictors of OS. In multivariable analysis change in the serum changes did not predict PFS however the ratio of T at 6-weeks over baseline was prognostic of ≥50% decline in PSA with an odds ratio of 0.93 (95% CI = 0.85-0.98, p-value = 0.039).
CONCLUSIONS
Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
321,30456899,"IqYmune® is an effective maintenance treatment for multifocal motor neuropathy: A randomised, double-blind, multi-center cross-over non-inferiority study vs Kiovig®-The LIME Study.","Intravenous immunoglobulin (IVIg) is the gold-standard for maintenance treatment of multifocal motor neuropathy (MMN). This phase III, randomised, double-blind, multi-centre, active-control, crossover study, aimed to evaluate the non-inferiority of IqYmune® relative to Kiovig®, primarily based on efficacy criteria. Twenty-two adult MMN patients, treated with any brand of IVIg (except Kiovig® or IqYmune®) at a stable maintenance dose within the range of 1 to 2 g/kg every 4 to 8 weeks, were randomised to receive either Kiovig® followed by IqYmune®, or IqYmune® followed by Kiovig®. Each product was administered for 24 weeks. The primary endpoint was the difference between IqYmune® and Kiovig® in mean assessments of modified Medical Research Council (MMRC) 10 sum score (strength of 5 upper-limb and 5 lower-limb muscle groups, on both sides, giving a score from 0 to 100) during the evaluation period (non-inferiority margin of Δ = 2). A linear mixed model analysis demonstrated the non-inferiority of IqYmune® relative to Kiovig®, independently of the covariates (value at baseline, treatment period, and treatment sequence). The estimated ""IqYmune® - Kiovig®"" difference was -0.01, with a 95% confidence interval (CI) -0.51 to 0.48. The number of adverse reactions (ARs) and the percentage of patients affected were similar for the two products: 39 ARs in 10 patients with IqYmune® vs 32 ARs in 11 patients with Kiovig®. No thromboembolic events nor haemolysis nor renal impairment were observed. In this first clinical trial comparing two IVIg brands for maintenance treatment of MMN, efficacy and tolerability of both brands were similar.",2019,"A linear mixed model analysis demonstrated the non-inferiority of IqYmune® relative to Kiovig®, independently of the covariates (value at baseline, treatment period, and treatment sequence).","['Twenty-two adult MMN patients, treated with any brand of IVIg (except Kiovig® or IqYmune®) at a stable maintenance dose within the range of 1 to 2 g/kg every 4 to 8 weeks', 'multifocal motor neuropathy']","['Intravenous immunoglobulin (IVIg', 'IqYmune®', 'Kiovig® followed by IqYmune®, or IqYmune® followed by Kiovig®']","['number of adverse reactions (ARs', 'MMN, efficacy and tolerability', 'IqYmune® and Kiovig® in mean assessments of modified Medical Research Council (MMRC) 10 sum score (strength of 5 upper-limb', 'thromboembolic events nor haemolysis nor renal impairment']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block (disorder)'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",10.0,0.179156,"A linear mixed model analysis demonstrated the non-inferiority of IqYmune® relative to Kiovig®, independently of the covariates (value at baseline, treatment period, and treatment sequence).","[{'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Léger', 'Affiliation': 'National Referral Center for Neuromuscular Diseases, University Hospital Pitié-Salpétrière, Paris, France.'}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Alfa Cissé', 'Affiliation': 'Global Medical Affairs, LFB, Les Ulis, France.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Department of Neurosciences, Molinette Hospital, Università degli Studi di Torino, Torino, Italy.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Grouin', 'Affiliation': 'Department of Statistics, Rouen University, Rouen, France.'}, {'ForeName': 'Haider', 'Initials': 'H', 'LastName': 'Katifi', 'Affiliation': 'Wessex Neurological Centre, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Nobile-Orazio', 'Affiliation': 'Neuromuscular and Neuroimmunology Service, Humanitas Clinical and Research Center, Milan University, Milan, Italy.'}, {'ForeName': 'Rabye', 'Initials': 'R', 'LastName': 'Ouaja', 'Affiliation': 'Global Medical Affairs, LFB, Les Ulis, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Pouget', 'Affiliation': 'National Referral Center for Neuromuscular Diseases, University Hospital La Timone, Marseille, France.'}, {'ForeName': 'Yusuf A', 'Initials': 'YA', 'LastName': 'Rajabally', 'Affiliation': 'School of Life and Health Sciences, Aston Brain Centre, Aston University, Birmingham, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sevilla', 'Affiliation': 'Neurology Department, La Fe University Hospital, Centro de investigación Biomédica en red de enfermedades raras (CIBERER), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Ingemar S J', 'Initials': 'ISJ', 'LastName': 'Merkies', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}]",Journal of the peripheral nervous system : JPNS,['10.1111/jns.12291']
322,31287199,Cost-effectiveness of combination therapy (Mechanical Diagnosis and Treatment and Transforaminal Epidural Steroid Injections) among patients with an indication for a Lumbar Herniated Disc surgery: Protocol of a randomized controlled trial.,"OBJECTIVES
The general consensus is that surgical treatment is advised when conservative methods fail in patients with lumbosacral radicular syndrome (LRS). Preliminary evidence from our pilot study indicates that combination therapy (mechanical diagnosis therapy and transforaminal epidural injections) can prevent surgical treatment in patients on the waiting list for surgery. The pilot study lacked a control group, and therefore, firm conclusions pertaining to effects could not be made. This study aims to determine if combination therapy, performed while being on the waiting list for lumbar herniated disc surgery, is effective and cost-effective compared with usual care (i.e., no intervention while being on the waiting list) among patients with a magnetic resonance imaging (MRI)-confirmed indication for a lumbar herniated disc surgery.
METHODS
A randomized controlled trial will be conducted with an economic evaluation. Patients aged 18 and above with incapacitating LRS, with leg pain and an MRI confirmed indication for lumbar disc hernia surgery, will be recruited from seven Dutch hospitals. While being on the waiting list for lumbar herniated disc surgery, patients will be randomized to either the combination therapy or usual care group. The primary outcome measure is the number of patients undergoing lumbar disc surgery during 12-month follow-up. Secondary outcomes include back and leg pain intensity (numeric pain rating scale), physical functioning (Roland Morris Disability Questionnaires-23), self-perceived recovery (global perceived effect), and health-related quality of life (EuroQol Five Dimensions Health Questionnaire (EQ-5D-5L) and 12-Item Short Form Health Survey (SF-12)). For the economic evaluation, societal and health care costs will be measured. Measurements moments are baseline, 1, 2, 4, 6, 9, and 12 months. Data will be analysed according to the intention-to-treat principle.
CONCLUSION
No randomized controlled trials have evaluated the effectiveness and cost-effectiveness of combination therapy compared with usual care in patients with an indication for lumbar herniated disc surgery, which emphasizes the importance of this study.",2020,"Secondary outcomes include back and leg pain intensity (numeric pain rating scale), physical functioning (Roland Morris Disability Questionnaires-23), self-perceived recovery (global perceived effect), and health-related quality of life (EuroQol Five Dimensions Health Questionnaire (EQ-5D-5L) and 12-Item Short Form Health Survey (SF-12)).","['patients with a magnetic resonance imaging (MRI)-confirmed indication for a lumbar herniated disc surgery', 'patients with lumbosacral radicular syndrome (LRS', 'patients with an indication for lumbar herniated disc surgery', 'Patients aged 18 and above with incapacitating LRS, with leg pain and an MRI confirmed indication for lumbar disc hernia surgery, will be recruited from seven Dutch hospitals', 'patients on the waiting list for surgery', 'patients with an indication for a Lumbar Herniated Disc surgery']","['combination therapy (Mechanical Diagnosis and Treatment and Transforaminal Epidural Steroid Injections', 'combination therapy (mechanical diagnosis therapy and transforaminal epidural injections', 'combination therapy']","['back and leg pain intensity (numeric pain rating scale), physical functioning (Roland Morris Disability Questionnaires-23), self-perceived recovery (global perceived effect), and health-related quality of life (EuroQol Five Dimensions Health Questionnaire (EQ-5D-5L) and 12-Item Short Form Health Survey (SF-12', 'number of patients undergoing lumbar disc surgery', 'effectiveness and cost-effectiveness', 'Cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0021818', 'cui_str': 'Disc, Herniated'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral (qualifier value)'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection (procedure)'}, {'cui': 'C0021486', 'cui_str': 'Extradural Injections'}]","[{'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.159189,"Secondary outcomes include back and leg pain intensity (numeric pain rating scale), physical functioning (Roland Morris Disability Questionnaires-23), self-perceived recovery (global perceived effect), and health-related quality of life (EuroQol Five Dimensions Health Questionnaire (EQ-5D-5L) and 12-Item Short Form Health Survey (SF-12)).","[{'ForeName': 'Elizabeth N', 'Initials': 'EN', 'LastName': 'Mutubuki', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van Helvoirt', 'Affiliation': 'Stichting Rugpoli, Delden, The Netherlands.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Carmen L A', 'Initials': 'CLA', 'LastName': 'Vleggeert-Lankamp', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Frank J P M', 'Initials': 'FJPM', 'LastName': 'Huygen', 'Affiliation': 'Department of Anesthesiology, Centre of Pain Medicine, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hanneke A H J', 'Initials': 'HAHJ', 'LastName': 'Klopper-Kes', 'Affiliation': 'Stichting Rugpoli, Delden, The Netherlands.'}, {'ForeName': 'Raymond W J G', 'Initials': 'RWJG', 'LastName': 'Ostelo', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1796']
323,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND
Monotherapy with immune checkpoint inhibitors has generally been unsuccessful in men with advanced prostate cancer. Preclinical data support the notion that cryotherapy may improve immune-mediated and anti-tumor responses. The objective of this study was to assess the safety and feasibility of whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation in men with oligometastatic hormone-sensitive prostate cancer.
METHODS
This single-institution, pilot trial recruited 12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016. Patients underwent whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab (6 doses). The primary clinical endpoints were the number of patients with a PSA level of <0.6 ng/mL at one year and the frequency of adverse events. Other outcome measures included progression-free survival and systemic therapy-free survival. Exploratory analyses included PD-L1 protein expression.
RESULTS
Forty two percent (5/12) of patients had a PSAs of <0.6 ng/mL at one year though only 2 of these patients had recovered their testosterone at this time point. Median progression-free survival was 14 months, and median systemic therapy-free survival was 17.5 months. PD-L1 expression was not detectable by IHC in patients with evaluable tissue. All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
CONCLUSIONS
Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8']
324,32298870,The effects of transcranial direct current stimulation on within- and cross-paradigm transfer following multi-session backward recall training.,"Transcranial direct current stimulation (tDCS) has been shown to enhance the efficacy and generalisation of working memory (WM) training, but there has been little systematic investigation into how coupling task-specific WM training with stimulation impacts more specifically on transfer to untrained tasks. This randomised controlled trial investigated the boundary conditions to transfer by testing firstly whether the benefits of training on backward digit recall (BDR) extend to untrained backward recall tasks and n-back tasks with different materials, and secondly which, if any, form of transfer is enhanced by tDCS. Forty-eight participants were allocated to one of three conditions: BDR training with anodal (10 min, 1 mA) or sham tDCS, or visual search training with sham tDCS, applied over the left dorsolateral prefrontal cortex. Transfer was assessed on within- (backward recall with digits, letters, and spatial locations) and cross-paradigm (n-back with digits and letters) transfer tests following three sessions of training and stimulation. On-task training gains were found, with transfer to other backward span but not n-back tasks. There was little evidence that tDCS enhanced on-task training or transfer. These findings indicate that training enhances paradigm-specific processes within WM, but that tDCS does not enhance these gains.",2020,"Transcranial direct current stimulation (tDCS) has been shown to enhance the efficacy and generalisation of working memory (WM) training, but there has been little systematic investigation into how coupling task-specific WM training with stimulation impacts more specifically on transfer to untrained tasks.",['Forty-eight participants'],"['transcranial direct current stimulation', 'Transcranial direct current stimulation (tDCS', 'BDR training with anodal (10\u202fmin, 1\u202fmA) or sham tDCS, or visual search training with sham tDCS']","['backward digit recall (BDR', 'tDCS enhanced on-task training or transfer']","[{'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",48.0,0.0236361,"Transcranial direct current stimulation (tDCS) has been shown to enhance the efficacy and generalisation of working memory (WM) training, but there has been little systematic investigation into how coupling task-specific WM training with stimulation impacts more specifically on transfer to untrained tasks.","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Byrne', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, 15 Chaucer Road, University of Cambridge, Cambridge CB2 7EF, UK. Electronic address: emb72@cam.ac.uk.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Ewbank', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, 15 Chaucer Road, University of Cambridge, Cambridge CB2 7EF, UK. Electronic address: m.ewbank@iesohealth.com.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Gathercole', 'Affiliation': 'Department of Psychiatry, Douglas House, 18b Trumpington Road, University of Cambridge, Cambridge CB2 8AH, UK. Electronic address: seg57@cam.ac.uk.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Holmes', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, 15 Chaucer Road, University of Cambridge, Cambridge CB2 7EF, UK. Electronic address: joni.holmes@mrc-cbu.cam.ac.uk.'}]",Brain and cognition,['10.1016/j.bandc.2020.105552']
325,32306021,[Effect of concentrated growth factors combined with guided tissue regeneration in treatment of classII furcation involvements of mandibular molars].,"OBJECTIVE
Tissues loss due to periodontal disease is typically treated by a variety of regenerative treatment modalities, including bone grafts, guided tissue regeneration (GTR) and growth factors, to reform the supporting tissues of teeth. Concentrated growth factors (CGF) are produced by centrifuging blood samples at alternating and controlled speeds using a special centrifuge. The purpose of this study was to evaluate whether GTR could improve the effect of CGF combined with bone graft in the treatment of classII furcations of mandibular molars.
METHODS
In the present study, thirty-five classII furcation involvements were included and randomly divided into two groups. The experimental group (n=17) accepted GTR combined with CGF and bone graft therapy, and the controlled group (n=18) accepted CGF combined with bone graft therapy. The clinical examinations and cone beam computed tomography (CBCT) were performed at baseline and 1 year post-surgery. Comparisons of clinical and CBCT data before and after operation between the experimental group and the control group were made.
RESULTS
The clinical and CBCT data of both groups were not statistically different at baseline (P>0.05). At the end of 1 year post-surgery, the clinical parameters of both groups were significantly improved (P<0.001). The probing depths of the experimental group were (4.81±1.95) mm and (3.56±1.94) mm, respectively, significantly higher than the changes of the control group (P<0.001). The vertical and horizontal attachment gains of the experimental group were (4.11±1.98) mm and (3.84±1.68) mm, respectively, significantly higher than the changes of the control group (P<0.001). At the end of 1 year post-surgery, the experimental group showed significantly higher bone gain at vertical and horizontal directions compared with those of the control group: (3.84±1.68) and (3.88±2.12) mm, respectively (P<0.001).
CONCLUSION
Within the limitation of the present study, GTR showed positive role in the effect of CGF combined with bone graft in the treatment of classII furcation involvements of mandibular molars.",2020,"At the end of 1 year post-surgery, the experimental group showed significantly higher bone gain at vertical and horizontal directions compared with those of the control group: (3.84±1.68) and (3.88±2.12) mm, respectively (P<0.001).
","['classII furcation involvements of mandibular molars', 'thirty-five classII furcation involvements', 'classII furcations of mandibular molars']","['GTR combined with CGF and bone graft therapy', 'concentrated growth factors combined with guided tissue regeneration', 'CGF combined with bone graft therapy', 'Concentrated growth factors (CGF', 'GTR', 'cone beam computed tomography (CBCT', 'CGF combined with bone graft']","['bone gain at vertical and horizontal directions', 'vertical and horizontal attachment gains']","[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0085147', 'cui_str': 'Regeneration, Guided Tissue'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",35.0,0.0415352,"At the end of 1 year post-surgery, the experimental group showed significantly higher bone gain at vertical and horizontal directions compared with those of the control group: (3.84±1.68) and (3.88±2.12) mm, respectively (P<0.001).
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Duan', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
326,32306085,Balneotherapy for knee osteoarthritis in S. Jorge: a randomized controlled trial.,"Osteoarthritis of the knee joint is a public health concern with considerable social impacts and related-costs. Among the treatments available, several benefits of bathing in natural mineral water have been proposed: (1) to identify possible health benefits (in terms of effects on dimensions of pain, functionality, emotional and social aspects, and quality of life) of a 3-week balneotherapy intervention in patients with knee osteoarthritis; (2) to assess the clinical relevance of any benefits detected; and (3) to determine if these effects persist. Participants of this randomized controlled trial (RCT) were 120 patients randomly assigned to (1) an experimental group (3 weeks of balneotherapy consisting of daily whirlpool baths, hydrokinesitherapy sessions, and knee shower/massages) or (2) control group in which no form of treatment apart from their usual analgesia medication was given. Treatment benefits were assessed using the following tools: (1) visual analogue scale (VAS) of pain, (2) Timed Up & Go Test (TUG), (3) WOMAC osteoarthritis questionnaire, and (4) SF 36 health survey questionnaire. In the experimental group, these tests were conducted immediately before treatment, immediately after treatment, and at 3 months of follow-up. Patients assigned to the control group were assessed at the study start and 3 months later. Data processing and statistical analysis were performed using the SPSS (Statistical Package for Social Science) version 22.0. Out of 60 patients in the experimental group, 45 were found to benefit from the treatment intervention in terms of pain relief among other aspects, and also when test scores were compared to those obtained in the control group. Improvements were often clinical relevant and in most patients persisted 3 months after treatment onset.",2020,"Out of 60 patients in the experimental group, 45 were found to benefit from the treatment intervention in terms of pain relief among other aspects, and also when test scores were compared to those obtained in the control group.",['patients with knee osteoarthritis'],"['Balneotherapy', 'balneotherapy intervention', 'balneotherapy consisting of daily whirlpool baths, hydrokinesitherapy sessions, and knee shower/massages) or (2) control group in which no form of treatment apart from their usual analgesia medication']","['pain relief', 'pain, functionality, emotional and social aspects, and quality of life', 'Timed Up & Go Test (TUG), (3) WOMAC osteoarthritis questionnaire, and (4) SF 36 health survey questionnaire', 'visual analogue scale (VAS) of pain, (2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0085867', 'cui_str': 'Balneotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0220792', 'cui_str': 'Whirlpool bath'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0541748', 'cui_str': 'Shower'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",120.0,0.0430787,"Out of 60 patients in the experimental group, 45 were found to benefit from the treatment intervention in terms of pain relief among other aspects, and also when test scores were compared to those obtained in the control group.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cantista', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar (ICBAS-UP), Universidade do Porto, Rua Jorge Viterbo Ferreira 228, 4050-313, Porto, Portugal. pedro.cantista@gmail.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Maraver', 'Affiliation': 'Professional School of Medical Hydrology, Faculty of Medicine, Universidad Complutense de Madrid, 28040, Madrid, Spain.'}]",International journal of biometeorology,['10.1007/s00484-020-01911-2']
327,32067096,"Ultra-high-fidelity virtual reality mastoidectomy simulation training: a randomized, controlled trial.","PURPOSE
Ultra-high-fidelity (UHF) graphics in virtual reality (VR) simulation might improve surgical skill acquisition in temporal bone training. This study aims to compare UHF VR simulation training with conventional, screen-based VR simulation training (cVR) with respect to performance and cognitive load (CL).
METHODS
In a randomized trial with a cross-over design, 24 students completed a total of four mastoidectomies in a VR temporal bone surgical simulator: two performances under UHF conditions using a digital microscope and two performances under conventional conditions using screen-based VR simulation. Performances were assessed by two blinded raters using an established assessment tool. In addition, CL was estimated as the relative change in secondary-task reaction time during simulation when compared with individual baseline measurements. Data were analyzed using linear mixed model analysis for repeated measurements.
RESULTS
The mean final-product performance score was significantly lower in UHF VR simulation compared to cVR simulation [mean difference 1.0 points out of 17 points, 95% CI (0.2-1.7), p = 0.02]. The most important factor for performance during UHF simulation was the ability to achieve stereovision (mean difference = 3.4 points, p < 0.001). Under the UHF VR condition, CL was significantly higher than during cVR (28% vs. 18%, respectively, p < 0.001).
CONCLUSION
UHF graphics in VR simulation training reduced performance and induced a higher CL in novices than conventional, screen-based VR simulation training. Consequently, UHF VR simulation training should be preceded by cVR training and might be better suited for the training of intermediates or experienced surgeons.",2020,The mean final-product performance score was significantly lower in UHF VR simulation compared to cVR ,['24 students completed a total of four mastoidectomies\xa0in a VR temporal bone surgical simulator: two performances under UHF conditions using a'],"['UHF VR simulation training with conventional, screen-based VR simulation training (cVR', 'digital microscope and two performances under conventional conditions using screen-based VR simulation', 'UHF graphics', 'cVR', 'Ultra-high-fidelity (UHF) graphics in virtual reality (VR) simulation', 'UHF VR simulation training', 'Ultra-high-fidelity virtual reality mastoidectomy simulation training']",['mean final-product performance score'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0198154', 'cui_str': 'Mastoidectomy'}, {'cui': 'C0039484', 'cui_str': 'Temporal Bone'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0181839', 'cui_str': 'Microscope, device (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0198154', 'cui_str': 'Mastoidectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0683758,The mean final-product performance score was significantly lower in UHF VR simulation compared to cVR ,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Frithioff', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Rigshospitalet, HovedOrtoCentret, Blegdamsvej 9, 2100, Copenhagen, Denmark. Andreasfrit@hotmail.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Frendø', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Rigshospitalet, HovedOrtoCentret, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Peter Trier', 'Initials': 'PT', 'LastName': 'Mikkelsen', 'Affiliation': 'The Alexandra Institute, Aarhus, Denmark.'}, {'ForeName': 'Mads Sølvsten', 'Initials': 'MS', 'LastName': 'Sørensen', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Rigshospitalet, HovedOrtoCentret, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Steven Arild Wuyts', 'Initials': 'SAW', 'LastName': 'Andersen', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Rigshospitalet, HovedOrtoCentret, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-05858-3']
328,32113972,Pressure and Traction Technique Improves Postural Control More Than Tactile Stimulation in Foot Plantar Fascia: A Randomized Single-Blind Trial.,"OBJECTIVE
To check the acute effects of manual pressure and traction technique on balance and plantar footprint variables.
DESIGN
A single-blind clinical study with 2 groups.
SETTING
Private practice.
PARTICIPANTS
Healthy participants (N=40; 28 female and 12 male) were recruited to carry out a single-blind study.
INTERVENTIONS
Experimental group performed a bilateral plantar fascia manual pressure and traction technique. Control group performed a tactile stimulation. The position of the participant, the therapist, and the time of application of the techniques (5min) were the same for both interventions.
MAIN OUTCOME MEASURES
We measured stabilometry variables and static footprint. The footprint variables were divided in rear, middle, and front foot areas.
RESULTS
Significant differences were found in stabilometry variables. There was an improvement in experimental group at X displacement with eyes open (P=.014) and surface eyes closed (P=.046) variables.
CONCLUSIONS
After technique the experimental group improved the stabilometry variables, specifically surface with eyes closed and X displacement with eyes open. The static footprint variables have not shown differences after the technique compared with the control group.",2020,"There was an improvement in experimental group at X displacement with eyes open (p=0.014) and surface eyes closed (p=0.046) variables.
","['Forty healthy participants (28 females and 12 males', 'foot plantar fascia']","['Pressure and Traction technique improve Postural Control more than tactile stimulation', 'bilateral plantar fascia manual pressure and traction technique', 'tactile stimulation', 'manual pressure and traction technique']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1562800', 'cui_str': 'Traction technique (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}]",[],40.0,0.0202167,"There was an improvement in experimental group at X displacement with eyes open (p=0.014) and surface eyes closed (p=0.046) variables.
","[{'ForeName': 'Eva María', 'Initials': 'EM', 'LastName': 'Martínez-Jiménez', 'Affiliation': 'Faculty of Physiotherapy and Nursing, Castilla la Mancha University, Toledo, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Becerro-de-Bengoa-Vallejo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Marta Elena', 'Initials': 'ME', 'LastName': 'Losa-Iglesias', 'Affiliation': 'Faculty of Health Sciences, Universidad Rey Juan Carlos, Alcorcon, Spain.'}, {'ForeName': 'José Ignacio', 'Initials': 'JI', 'LastName': 'Díaz-Velázquez', 'Affiliation': 'Rehabilitación Premium Madrid, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Palomo-López', 'Affiliation': 'Department of Nursing, University Center of Plasencia, Plasencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain. Electronic address: davidrodriguezsanz@ucm.es.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-López', 'Affiliation': 'Research, Health and Podiatry Group, Department of Health Sciences, Faculty of Nursing and Podriarty, Universidade da Coruña, Ferrol, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.01.017']
329,31814511,Impact of Tailored Interventions on Receipt of a Preference-Concordant Colorectal Cancer Screening Test.,"Background. Individuals at average risk for colorectal cancer (CRC) have multiple test options. Preference for a specific test modality may affect decision making about CRC screening. The current study examined 1) the sociodemographic and health belief characteristics of average-risk participants with a test preference for stool blood test (SBT) versus those with a preference of colonoscopy, and following receipt of a tailored CRC screening intervention, 2) the percentage of participants who completed a preference-concordant CRC screening test, and 3) the sociodemographic, health care experience, and health belief characteristics and intervention group(s) associated with completion of a preference-concordant screening test. Methods. Participants ( N = 603) were female, aged 50 to 75 years, at average CRC risk, not currently up-to-date with CRC screening recommendations, had Internet access, and were randomized to receive 1 of 3 tailored CRC screening promotion interventions. Multivariable logistic regression analyses were conducted. Results. Most women (64%) preferred SBT, whereas 36% preferred colonoscopy. There were significant differences in test preference by age, stage of change for the specific tests, perceived benefits of CRC screening, perceived barriers to both tests, and self-efficacy for colonoscopy. Two hundred thirty participants completed CRC screening at 6 months post-intervention. Of those, most (84%) completed a test concordant with their preference. Multivariable analyses revealed that compared with participants completing a preference-discordant test, those completing a preference-concordant test were older ( P = 0.01), had health insurance ( P < 0.05), and were in the phone counseling-only group ( P < 0.01). Conclusions. High levels of completion of preference-concordant CRC screening can be achieved by educating average-risk patients about the multiple screening test options, soliciting their preferences, and offering testing that is concordant with their preference.",2020,"There were significant differences in test preference by age, stage of change for the specific tests, perceived benefits of CRC screening, perceived barriers to both tests, and self-efficacy for colonoscopy.","['average-risk participants with a test preference for stool blood test (SBT) versus those with a preference of colonoscopy, and following receipt of a tailored CRC screening intervention, 2) the percentage of participants who completed a preference-concordant CRC screening test, and 3) the sociodemographic, health care experience, and health belief characteristics and intervention group(s) associated with completion of a preference-concordant screening test', 'Individuals at average risk for colorectal cancer (CRC', 'Participants ( N = 603) were female, aged 50 to 75 years, at average CRC risk, not currently up-to-date with CRC screening recommendations, had Internet access', 'Two hundred thirty participants completed']","['CRC screening promotion interventions', 'Tailored Interventions']","['health insurance', 'specific tests, perceived benefits of CRC screening, perceived barriers to both tests, and self-efficacy', 'CRC screening']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",603.0,0.0240923,"There were significant differences in test preference by age, stage of change for the specific tests, perceived benefits of CRC screening, perceived barriers to both tests, and self-efficacy for colonoscopy.","[{'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Christy', 'Affiliation': 'Department of Health Outcomes and Behavior, Division of Population Science, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine and Richard M. Fairbanks School of Public Health, Indianapolis, IN, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Stump', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rawl', 'Affiliation': 'Indiana University Simon Cancer Center, Indianapolis, IN, USA.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University Simon Cancer Center, Indianapolis, IN, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X19890603']
330,32303784,Comparison of types 2 and 3 quadratus lumborum muscle blocks : Open inguinal hernia surgery in patients with spinal anesthesia.,"OBJECTIVE
The efficacy of quadratus lumborum muscle block (QLB) in abdominal surgery is known; however, the efficacy of different QLB types is unclear. The objective of this study was to investigate the effects of ultrasound-guided QLB type 2 and type 3 on postoperative opioid consumption and pain scores in patients undergoing inguinal hernia surgery.
MATERIAL AND METHODS
In this study 60 patients undergoing open inguinal hernia surgery were randomly assigned to 3 groups. Group QLB2 received ultrasound-guided QLB type 2 and group QLB3 received ultrasound-guided QLB type 3 with 0.25% 20 mL bupivacaine. In the control group (group C) no intervention was performed. Postoperative analgesia was performed intravenously with 1000 mg paracetamol every 6 h and patient-controlled analgesia with fentanyl. Postoperative visual analog scale scores (VAS), opioid consumption, and first analgesic requirement time were evaluated.
RESULTS
Fentanyl consumption was significantly higher in group C compared to the other groups at all time intervals (p < 0.05). Fentanyl consumption was significantly higher in group QLB2 compared to QLB3 at the 4-8 h, 8-24 h, and total 24 h. Passive VAS 4h and 8 h, active VAS 4h, 8h, and 12 h were significantly lower in group QLB3 compared to QLB2 (p < 0.05). The first analgesic time was significantly later in group QLB2 compared to group C (280.52 ± 89.20 min and 183.75 ± 42.79 min, respectively) and even later in group QLB3 compared to the other two groups (463.42 ± 142.43 min, p < 0.05).
CONCLUSION
The use of QLB2 and QLB3 decreased postoperative opioid consumption and pain scores in patients undergoing inguinal hernia surgery. Furthermore, QLB3 provided more effective and longer lasting postoperative analgesia and lower opioid consumption compared to QLB2.",2020,The use of QLB2 and QLB3 decreased postoperative opioid consumption and pain scores in patients undergoing inguinal hernia surgery.,"['patients undergoing inguinal hernia surgery', 'patients with spinal anesthesia', '60 patients undergoing open inguinal hernia surgery']","['QLB2 and QLB3', 'types 2 and 3 quadratus lumborum muscle blocks : Open inguinal hernia surgery', 'quadratus lumborum muscle block (QLB', 'bupivacaine', 'ultrasound-guided QLB type 2 and type 3', 'paracetamol every 6\u202fh and patient-controlled analgesia with fentanyl', 'QLB3', 'ultrasound-guided QLB type 2 and group']","['analgesic time', 'effective and longer lasting postoperative analgesia and lower opioid consumption', 'Postoperative visual analog scale scores (VAS), opioid consumption, and first analgesic requirement time', 'postoperative opioid consumption and pain scores', 'Fentanyl consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]",60.0,0.0368686,The use of QLB2 and QLB3 decreased postoperative opioid consumption and pain scores in patients undergoing inguinal hernia surgery.,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bagbanci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kursad', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey. m_yayik@hotmail.com.'}, {'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Karadeniz', 'Affiliation': 'Department of General Surgery, Ataturk University School of Medicine, Erzurum, Turkey.'}]",Der Anaesthesist,['10.1007/s00101-020-00766-x']
331,30957240,Tailored interventions by community pharmacists and general practitioners improve adherence to statins in a Spanish randomized controlled trial.,"OBJECTIVE
To evaluate the impact of health professionals' intervention on adherence to statins, the influence on total cholesterol levels, and lifestyle patterns in patients with hypercholesterolemia and analyze the differences according to the center of recruitment.
STUDY SETTING
Forty-six community pharmacies and 50 primary care centers of Spain.
STUDY DESIGN
Randomized controlled trial design (n = 746). Patients were assigned into adherent (ADH) or nonadherent group depending on their initial adherence to statins. Nonadherent patients were randomly assigned to intervention (INT) or nonintervention (NOINT) group. Patients enrolled in the INT group received an intervention depending on the cause of nonadherence. Patients in the ADH and NOINT groups received usual care. Intention-to-treat (ITT) analysis was performed with multiple imputation to replace the missing data.
DATA COLLECTION
Adherence, total cholesterol levels, and lifestyle behaviors.
FINDINGS
The odds of becoming adherent during the 6 months was higher in the INT group compared to the NOINT group (OR = 1,49; 95% CI: 1.30-1.76; P < 0.001), especially in the community pharmacy group (OR = 2.34; 95% CI: 1.81-3.03; P < 0.001). Adherent patients showed lower values of total cholesterol compared with nonadherent patients at baseline (ADH: 200.3 mg/dL vs NOADH: 216.7 mg/dL; P < 0.001) and at the endpoint (ADH: 197.3 mg/dL vs NOADH: 212.2 mg/dL; P < 0.001). More patients enrolled in the INT group practices exercise at the end of the study (INT: +26.6 percent; P = 0.002), and a greater number of patients followed a diet to treat hypercholesterolemia (+30.2 percent; P < 0.001).
CONCLUSIONS
The intervention performed by health professionals, especially by community pharmacists, improved adherence to statins by hypercholesterolemic patients, and this improvement in adherence was accompanied by a reduction in total cholesterol levels and a healthier lifestyle.",2019,Adherent patients showed lower values of total cholesterol compared with nonadherent patients at baseline (ADH: 200.3 mg/,"['patients with hypercholesterolemia', 'Forty-six community pharmacies and 50 primary care centers of Spain', 'Nonadherent patients']","[""health professionals' intervention"", 'dL vs NOADH', 'intervention (INT) or nonintervention (NOINT', 'usual care']","['Adherence, total cholesterol levels, and lifestyle behaviors', 'total cholesterol', 'total cholesterol levels, and lifestyle patterns', 'total cholesterol levels and a healthier lifestyle']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]",746.0,0.0480278,Adherent patients showed lower values of total cholesterol compared with nonadherent patients at baseline (ADH: 200.3 mg/,"[{'ForeName': 'Ainhoa', 'Initials': 'A', 'LastName': 'Oñatibia-Astibia', 'Affiliation': 'Official Pharmacist Association of Gipuzkoa, Donostia/San Sebastián, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Malet-Larrea', 'Affiliation': 'Official Pharmacist Association of Gipuzkoa, Donostia/San Sebastián, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Larrañaga', 'Affiliation': 'Official Pharmacist Association of Gipuzkoa, Donostia/San Sebastián, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Gastelurrutia', 'Affiliation': 'Pharmaceutical Care Research Group, Faculty of Pharmacy, University of Granada, Granada, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Calvo', 'Affiliation': 'Pharmaceutical Technology Department, Faculty of Pharmacy, University of the Basque Country, Vitoria, Spain.'}, {'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Ramírez', 'Affiliation': 'Treatment Adherence Observatory, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cantero', 'Affiliation': 'Treatment Adherence Observatory, Madrid, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Garay', 'Affiliation': 'Official Pharmacist Association of Gipuzkoa, Donostia/San Sebastián, Spain.'}, {'ForeName': 'Estibaliz', 'Initials': 'E', 'LastName': 'Goyenechea', 'Affiliation': 'Official Pharmacist Association of Gipuzkoa, Donostia/San Sebastián, Spain.'}]",Health services research,['10.1111/1475-6773.13152']
332,32305222,Prognostic Usefulness of Myocardial Work in Patients With Heart Failure and Reduced Ejection Fraction Treated by Sacubitril/Valsartan.,"The noninvasive assessment of myocardial work (MW) by pressure-strain loops analysis (PSL) is a relative new tool for the evaluation of myocardial performance. Sacubitril/Valsartan is a treatment for heart failure with reduced ejection fraction (HFrEF) which has a spectacular effect on the reduction of cardiovascular events (major adverse cardiovascular events [MACEs]). This study aimed to evaluate the short- and medium-term effect of Sacubitril/Valsartan treatment on MW parameters and the prognostic value of MW in this specific group of patients. Seventy-nine patients with HFrEF (mean age: 66 ± 12 years; LV ejection fraction: 28% ± 9%) were prospectively included in the study and treated with Sacubitril/Valsartan. Echocardiographic examination was performed at baseline, and after 6- and 12-month of therapy with Sacubitril/Valsartan. Sacubitril/Valsartan significantly increased myocardial constructive work (CW) (1023 ± 449 vs 1424 ± 484 mm Hg%, p <0.0001) and myocardial work efficiency (WE) [87 (78to 90) vs 90 (86 to 95), p <0.0001]. During FU (2.6 ± 0.9 years), MACEs occurred in 13 (16%) patients. After correction for LV size, LV ejection fraction and WE, global myocardial constructive work (CW) was the only predictor of MACEs [hazard ratio [HR] 0.99 (0.99 to 1.00), p = 0.04]. A CW <910 mm Hg identified patients at particularly increase risk of MACEs [HR 11.09 (1.45 to 98.94), p = 0.002, log-rank test p <0.0001]. In conclusion, in patients with HFrEF who receive a comprehensive background beta-blocker and mineral-corticoid receptor antagonist therapy, Sacubitril/Valsartan induces a significant improvement of myocardial CW and WE. In this population, the estimation of CW before the initiation of Sacubitril/Valsartan allows the prediction of MACEs.",2020,"After correction for LV size, LV ejection fraction and WE, global myocardial constructive work (CW) was the only predictor of MACEs [hazard ratio [HR] 0.99 (0.99 to 1.00), p = 0.04].","['patients', 'Patients With Heart Failure and Reduced Ejection Fraction Treated by', 'Seventy-nine patients with HFrEF (mean age: 66 ± 12 years; LV ejection fraction: 28% ± 9%) were prospectively included in the study and treated with', 'patients with HFrEF who receive a']","['pressure-strain loops analysis (PSL', 'Sacubitril/Valsartan', 'comprehensive background beta-blocker and mineral-corticoid receptor antagonist therapy']","['myocardial CW and WE', 'Echocardiographic examination', 'MACEs', 'myocardial constructive work (CW', 'myocardial work efficiency', 'LV size, LV ejection fraction and WE, global myocardial constructive work (CW']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",79.0,0.0223874,"After correction for LV size, LV ejection fraction and WE, global myocardial constructive work (CW) was the only predictor of MACEs [hazard ratio [HR] 0.99 (0.99 to 1.00), p = 0.04].","[{'ForeName': 'Yanis', 'Initials': 'Y', 'LastName': 'Bouali', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Donal', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Alban', 'Initials': 'A', 'LastName': 'Gallard', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Laurin', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Hubert', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Auriane', 'Initials': 'A', 'LastName': 'Bidaut', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Galli', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France. Electronic address: elena.galli@chu-rennes.fr.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.03.031']
333,32305223,Characteristics and Outcome of Patients ≥75 Years of Age With Prior Coronary Artery Bypass Grafting Admitted for an Acute Coronary Syndrome.,"The prognostic role of previous coronary artery bypass (CABG) in elderly patients admitted to hospital for an acute coronary syndrome (ACS) is unclear. Therefore, the aim of this study was to compare the prognosis of patients aged ≥75 years admitted for an ACS with or without previous history of CABG. The primary outcome of the study was a composite of overall mortality, recurrent nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 1-year follow-up. We included 2,253 ACS patients, aged 81 (78 to 85) years enrolled in 3 multicenter studies (the Italian Elderly ACS study, the LADIES ACS study, and the Elderly ACS 2 randomised trial) - 178 (7.9%) with previous CABG, 2,075 (92.1%) without. Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission. However, both at univariate analysis and after adjustment for the most relevant covariates (sex, age, previous myocardial infarction, type of ACS, left ventricular ejection fraction, and serum creatinine on admission), previous CABG did not show any statistically significant association with 1-year outcome (adjusted hazard ratio 0.85; 95% confidence interval 0.61 to 1.19; p = 0.353). In conclusion, our study suggests that elderly ACS patients with previous CABG have worse basal clinical characteristics. Nevertheless, in a broad cohort of patients mostly treated with percutaneous coronary intervention during the index event, previous CABG did not confer independent additional risk of major adverse cardiovascular events at 1-year follow-up.",2020,"Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission.","['Patients ≥75 Years of Age', 'patients aged ≥75 years admitted for an ACS with or without previous history of CABG', '2,253 ACS patients, aged 81 (78 to 85) years enrolled in 3 multicenter studies (the Italian Elderly ACS study, the LADIES ACS study, and the Elderly ACS 2 randomised trial', 'elderly ACS patients with previous CABG', 'elderly patients admitted to hospital for an acute coronary syndrome (ACS']","['percutaneous coronary intervention', 'coronary artery bypass (CABG']","['composite of overall mortality, recurrent nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 1-year follow-up', 'cardiovascular risk factors, lower ejection fraction', 'myocardial infarction, type of ACS, left ventricular ejection fraction, and serum creatinine on admission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0457453', 'cui_str': 'On admission'}]",2253.0,0.0523231,"Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission.","[{'ForeName': 'Nuccia', 'Initials': 'N', 'LastName': 'Morici', 'Affiliation': 'Unità di Cure Intensive Cardiologiche, De Gasperis Cardio-Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy; Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milano, Italy. Electronic address: nuccia.morici@ospedaleniguarda.it.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'De Rosa', 'Affiliation': 'Cardiology Unit, Cardiovascular and Thoracic Department, University Hospital ""San Giovanni di Dio e Ruggi d\'Aragona"", Salerno, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Crimi', 'Affiliation': 'Interventional Cardiology Unit, Cardio Thoraco Vascular Department, IRCCS Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'De Luca', 'Affiliation': 'Division of Cardiology, S. Giovanni Evangelista Hospital, Rome, Italy.'}, {'ForeName': 'Luca A', 'Initials': 'LA', 'LastName': 'Ferri', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lenatti', 'Affiliation': 'Division of Cardiology, Ospedale Manzoni, Lecco, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Piatti', 'Affiliation': 'Division of Cardiology, Ospedale Manzoni, Lecco, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Tortorella', 'Affiliation': 'Division of Cardiology, Ospedale Vaio, Fidenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Grosseto', 'Affiliation': 'Division of Cardiology, Ospedale Infermi, Rimini, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Division of Cardiology, Ospedale Infermi, Rimini, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bossi', 'Affiliation': 'Unità di Cure Intensive Cardiologiche, De Gasperis Cardio-Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Montalto', 'Affiliation': 'Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Antonicelli', 'Affiliation': 'Center of Clinical Pathology and Innovative Therapy, Italian National Research Center on Aging (IRCCS INRCA), Ancona, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Alicandro', 'Affiliation': 'Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': 'Cardiovascular Department, Ospedale ""Maggiore della Carità"", Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'De Servi', 'Affiliation': 'University of Pavia, Pavia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Savonitto', 'Affiliation': 'Division of Cardiology, Ospedale Manzoni, Lecco, Italy.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.03.021']
334,32179067,"Emerging From the Haze: A Multicenter, Controlled Pilot Study of a Multidimensional, Psychoeducation-Based Cognitive Rehabilitation Intervention for Breast Cancer Survivors Delivered With Telehealth Conferencing.","OBJECTIVE
To quantify the effect of a psychoeducation-based cognitive rehabilitation intervention on breast cancer survivors' self-report of cognitive function and investigate the feasibility of accrual, adherence, and multisite program delivery using secure telehealth conferencing.
DESIGN
Prospective, nonblinded, wait-list controlled pilot study.
SETTING
Nonprofit academic medical center and university medical center with associated community practice affiliates.
PARTICIPANTS
Adult female survivors of stage I-III breast cancer reporting cognitive complaints 2 months to 5 years after chemotherapy (N=61). Ongoing endocrine and/or anti-HER-2 therapy was allowed. Patients were excluded for history of other conditions involving impaired cognitive function. Combination referred and volunteered sample. In total, 107 women were screened, 61 consented, and 52 analyzed. No attrition due to adverse events. Group allocation was based on consent timing and next scheduled cohort to minimize wait time for wait-list controls.
INTERVENTION
Psychoeducation-based cognitive rehabilitation intervention delivered in a group setting during 6 weekly 2.5-hour classes. Included presentation, class exercises, discussion, and homework exercises. Provided in-person and virtually by Health Insurance Portability and Accountability Act compliant and encrypted telehealth conferencing.
MAIN OUTCOME MEASURES
Primary: self-report of perceived cognitive function (PCF) was compared between the intervention group (n=27) and wait-list controls (n=28) with the Functional Assessment of Cancer Therapy-Cognition perceived cognitive impairment subscale. Secondary: feasibility for multisite delivery via teleconferencing was measured by total accrual, percent adherence to 4 of the 6 weeks of content, and participant satisfaction ratings.
RESULTS
The intervention group demonstrated improvement in PCF both at the conclusion of the intervention and 1 month later (P<.01). Within-group improvement in PCF was maintained at 6 and 12 months (P<.01).
CONCLUSION
These study results provide further preliminary evidence of the efficacy of psychoeducation-based cognitive rehabilitation as an intervention for decreased PCF in breast cancer survivors with cognitive complaints after chemotherapy. Feasibility for accrual, adherence, and participant satisfaction with secure telehealth conferencing was demonstrated. These positive pilot study results will inform future work.",2020,"Within-group improvement in PCF was maintained at 6- and 12-months (p<0.01).
","['Non-profit academic medical center and university medical center with associated community practice affiliates', 'breast cancer survivors', 'breast cancer survivors with cognitive complaints following chemotherapy', '107 women screened, 61 consented, 52 analyzed', 'Adult female survivors of stage I-III breast cancer reporting cognitive complaints 2-months-5-years after chemotherapy']","['Primary: Self-report of perceived cognitive function (PCF', 'psycho-education-based cognitive rehabilitation', 'psycho-education-based cognitive rehabilitation intervention', 'Psycho-education-based cognitive rehabilitation intervention', 'multi-dimensional, psycho-education-based cognitive rehabilitation intervention', 'telehealth conferencing']","['PCF', 'Cancer Therapy-Cognition Perceived Cognitive Impairment Subscale', 'Included presentation, class exercises, discussion, and homework exercises']","[{'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}]",107.0,0.0283218,"Within-group improvement in PCF was maintained at 6- and 12-months (p<0.01).
","[{'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Myers', 'Affiliation': 'University of Kansas School of Nursing, Kansas City, KS.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Cook-Wiens', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Baynes', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Mi-Yeoung', 'Initials': 'MY', 'LastName': 'Jo', 'Affiliation': 'Independent Practice, Sherman Oaks, CA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Krigel', 'Affiliation': 'Midwest Cancer Alliance at the University of Kansas Medical Center, Westwood, KS.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Klemp', 'Affiliation': 'University of Kansas Cancer Center, Westwood, KS.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Asher', 'Affiliation': 'Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, CA. Electronic address: arash.asher@cshs.org.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.01.021']
335,31013363,MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial).,"Aramchol, an oral stearoyl-coenzyme-A-desaturase-1 inhibitor, has been shown to reduce hepatic fat content in patients with primary nonalcoholic fatty liver disease (NAFLD); however, its effect in patients with human immunodeficiency virus (HIV)-associated NAFLD is unknown. The aramchol for HIV-associated NAFLD and lipodystrophy (ARRIVE) trial was a double-blind, randomized, investigator-initiated, placebo-controlled trial to test the efficacy of 12 weeks of treatment with aramchol versus placebo in HIV-associated NAFLD. Fifty patients with HIV-associated NAFLD, defined by magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) ≥5%, were randomized to receive either aramchol 600 mg daily (n = 25) or placebo (n = 25) for 12 weeks. The primary endpoint was a change in hepatic fat as measured by MRI-PDFF in colocalized regions of interest. Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI. The mean (± standard deviation) of age and body mass index were 48.2 ± 10.3 years and 30.7 ± 4.6 kg/m 2 , respectively. There was no difference in the reduction in mean MRI-PDFF between the aramchol group at -1.3% (baseline MRI-PDFF 15.6% versus end-of-treatment MRI-PDFF 14.4%, P = 0.24) and the placebo group at -1.4% (baseline MRI-PDFF 13.3% versus end-of-treatment MRI-PDFF 11.9%, P = 0.26). There was no difference in the relative decline in mean MRI-PDFF between the aramchol and placebo groups (6.8% versus 1.1%, P = 0.68). There were no differences in MRE-derived and VCTE-derived liver stiffness and whole-body (fat and muscle) composition analysis by MRI or DXA. Compared to baseline, end-of-treatment aminotransferases were lower in the aramchol group but not in the placebo arm. There were no significant adverse events. Conclusion: Aramchol, over a 12-week period, did not reduce hepatic fat or change body fat and muscle composition by using MRI-based assessment in patients with HIV-associated NAFLD (clinicaltrials.gov ID:NCT02684591).",2019,"Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI.","['Fifty patients with HIV-associated NAFLD, defined by magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) ≥5', 'patients with primary nonalcoholic fatty liver disease (NAFLD', 'HIV-associated NAFLD']","['placebo', 'Aramchol, an oral stearoyl-coenzyme-A-desaturase-1 inhibitor', 'aramchol 600 mg daily (n\xa0=\xa025) or placebo', 'aramchol versus placebo', 'Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor']","['hepatic fat or change body fat and muscle composition', 'MRE-derived and VCTE-derived liver stiffness and whole-body (fat and muscle) composition analysis by MRI or DXA', 'change in hepatic fat', 'changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI', 'mean (± standard deviation) of age and body mass index', 'mean MRI-PDFF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1122583', 'cui_str': '(3beta,5beta,7alpha,12alpha)-7,12-dihydroxy-3-(icosanoylamino)cholan-24-oic acid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0075202', 'cui_str': 'stearyl-CoA'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1518156', 'cui_str': 'Magnetic Resonance Elastography'}, {'cui': 'C3854624', 'cui_str': 'Vibration controlled transient elastography'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1142375', 'cui_str': 'Magnetic resonance imaging of whole body'}, {'cui': 'C0412692', 'cui_str': 'Magnetic resonance imaging of heart'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",50.0,0.376089,"Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI.","[{'ForeName': 'Veeral H', 'Initials': 'VH', 'LastName': 'Ajmera', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cachay', 'Affiliation': 'Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ramers', 'Affiliation': 'Family Health Center, San Diego, CA.'}, {'ForeName': 'Irine', 'Initials': 'I', 'LastName': 'Vodkin', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Bassirian', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Mangla', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Richele', 'Initials': 'R', 'LastName': 'Bettencourt', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Jeannette L', 'Initials': 'JL', 'LastName': 'Aldous', 'Affiliation': 'San Ysidro Health, San Diego, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'San Ysidro Health, San Diego, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Adrija', 'Initials': 'A', 'LastName': 'Mamidipalli', 'Affiliation': 'Liver Imaging Group, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Boehringer', 'Affiliation': 'Liver Imaging Group, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Aslam', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Olof Dahlqvist', 'Initials': 'OD', 'LastName': 'Leinhard', 'Affiliation': 'AMRA Medical AB, Linköping, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Richards', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Sirlin', 'Affiliation': 'Liver Imaging Group, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30674']
336,30829460,Effects of a physical activity programme to prevent physical performance decline in onco-geriatric patients: a randomized multicentre trial.,"BACKGROUND
Older adults with cancer experience negative long-term functional effects of both cancer and treatments. Exercise may minimize their age-related and cancer-related functional decline.
METHODS
We conducted a multicentre open-label 12 month randomized clinical trial with two parallel arms including participants aged ≥70 years with lymphoma or carcinoma requiring curative treatment. The study started at the beginning of any phase of cancer treatment (surgery, chemotherapy, or radiotherapy). The usual care group (UCG) received the current national recommendations in physical activity (a guideline without specific counselling). The intervention group (IG) received 1 year phoned physical activity advice individually adapted to physical assessment (twice a month during the first 6 months and then monthly). The primary outcome was the proportion of subjects with a 1 year decreased short physical performance battery (SPPB) score of 1 point or more. Physical, cognitive, and clinical secondary outcomes were also investigated.
RESULTS
We allocated 301 participants (age 76.7 ± 5.0, female 60.6%) to each group. At baseline, the median SPPB was 10/12 in both groups. Breast was the most frequent tumour site (35.7%). After 1 year, 14.0% of participants in the UCG and 18.7% in the IG had a decrease in SPPB score of 1 point or more (P = 0.772). At 2 years, there was no difference in SPPB, gait speed, International Physical Activity Questionnaire score, and verbal fluency. Subgroup analyses after 2 years showed a decline in SPPB for 29.8% of UCG and 5.0% of IG breast cancer participants (P = 0.006), in 21.7% of UCG and 6.2% of IG female participants (P = 0.019), and in 24.5% of UCG and 11.1% of IG normal nutritional status participants (P = 0.009). Falls, hospitalization, institutionalization, and death rates were similar in both groups.
CONCLUSIONS
Personalized phoned physical activity advice had not reduced functional decline at 1 year but provided preliminary evidence that may prevent physical performance decline at 2 years in older adults with breast cancer.",2019,"At 2 years, there was no difference in SPPB, gait speed, International Physical Activity Questionnaire score, and verbal fluency.","['301 participants (age 76.7\xa0±\xa05.0, female 60.6%) to each group', 'onco-geriatric patients', 'Older adults with cancer', 'participants aged ≥70\xa0years with lymphoma or carcinoma requiring curative treatment', 'older adults with breast cancer']","['cancer treatment (surgery, chemotherapy, or radiotherapy', 'physical activity programme', 'intervention group (IG) received 1\xa0year phoned physical activity advice individually adapted to physical assessment', 'usual care group (UCG) received the current national recommendations in physical activity (a guideline without specific counselling']","['proportion of subjects with a 1\xa0year decreased short physical performance battery (SPPB) score of 1 point or more', 'SPPB, gait speed, International Physical Activity Questionnaire score, and verbal fluency', 'physical performance decline', 'decline in SPPB', 'Falls, hospitalization, institutionalization, and death rates', 'SPPB score', 'median SPPB']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score (observable entity)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0021629', 'cui_str': 'Institutionalization'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",301.0,0.113944,"At 2 years, there was no difference in SPPB, gait speed, International Physical Activity Questionnaire score, and verbal fluency.","[{'ForeName': 'Haritz', 'Initials': 'H', 'LastName': 'Arrieta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Bizkaia, Spain.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Astrugue', 'Affiliation': ""Pole de Santé Publique, Service d'Information Médicale, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique, CHU de Bordeaux, Bordeaux, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Regueme', 'Affiliation': 'Pôle de gérontologie clinique, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Durrieu', 'Affiliation': 'Pôle de gérontologie clinique, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Maillard', 'Affiliation': ""Pole de Santé Publique, Service d'Information Médicale, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique, CHU de Bordeaux, Bordeaux, France.""}, {'ForeName': 'Alban', 'Initials': 'A', 'LastName': 'Rieger', 'Affiliation': 'Pôle de gérontologie clinique, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Terrebonne', 'Affiliation': 'Pôle appareil digestif, endocrinologie et nutrition, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Laurent', 'Affiliation': 'Pôle appareil digestif, endocrinologie et nutrition, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Maget', 'Affiliation': 'CLCC Reims, Institut Jean Godinot, Reims, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Servent', 'Affiliation': 'CLCC Lille, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lavau-Denès', 'Affiliation': 'CHU de Limoges, Limoges Cedex, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Dauba', 'Affiliation': 'CH Mont de Marsan, Mont-de-Marsan, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Fonck', 'Affiliation': 'CLCC Bordeaux, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': ""Pole de Santé Publique, Service d'Information Médicale, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique, CHU de Bordeaux, Bordeaux, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Bourdel-Marchasson', 'Affiliation': 'CNRS, RMSB, UMR 5536, Bordeaux, France.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12382']
337,32300812,"Letter to the Editor: ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],['High Diet-Induced Thermogenesis'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]",[],,0.0175443,,"[{'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa208']
338,32301407,Effect of Daily Consumption of Cranberry Beverage on Insulin Sensitivity and Modification of Cardiovascular Risk Factors in Obese Adults: A Pilot Randomized Placebo-Controlled Study.,"Cranberries are high in polyphenols and epidemiologic studies have shown a high polyphenol diet may reduce risk factors for diabetes and cardiovascular disease. This study aimed to determine if short term cranberry beverage consumption would improve insulin sensitivity and other cardiovascular risk factors. Thirty-five obese individuals with elevated fasting glucose or impaired glucose tolerance participated in a randomized, double blind, placebo controlled, parallel designed pilot trial. Participants consumed 450 mL of low-calorie cranberry beverage or placebo daily for 8 weeks. Changes in insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, resting metabolic rate, glucose tolerance, lipid profiles, and oxidative stress biomarkers were evaluated. Change in insulin sensitivity via hyperinsulinemic euglycemic clamp was not different between the two groups. Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02). When stratified by baseline C-reactive protein (CRP) levels, participants with high CRP levels (> 4 mg/L) benefited more from cranberry consumption. In this group, significant differences in the mean change from baseline between the cranberry (n=10) and the placebo groups (n=7) in levels of triglyceride (-13.75% vs +10.32%; p=0.04), nitrate (+3.26 µM/L vs -6.28 µM/L; p=0.02), and 8-isoprostane (+0.32 pg/mL vs +30.8 pg/mL; p=0.05) were observed. These findings indicate that 8 weeks of daily cranberry beverage consumption may not impact insulin sensitivity but may be helpful in lowering triglycerides and changing certain oxidative stress biomarkers in obese individuals with a proinflammatory state.",2020,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","['Thirty-five obese individuals with elevated fasting glucose or impaired glucose tolerance participated', 'Obese Adults', 'obese individuals with a proinflammatory state']","['low-calorie cranberry beverage or placebo', 'polyphenol diet', 'placebo', 'Daily Consumption of Cranberry Beverage', 'Placebo']","['Insulin Sensitivity and Modification of Cardiovascular Risk Factors', 'Levels of 8-isoprostane (biomarker of lipid peroxidation', 'insulin sensitivity via hyperinsulinemic euglycemic clamp', 'insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, resting metabolic rate, glucose tolerance, lipid profiles, and oxidative stress biomarkers', 'insulin sensitivity and other cardiovascular risk factors', 'levels of triglyceride']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.644559,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA70808.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Zhang', 'Affiliation': 'Ocean Spray Cranberries, Inc., One Ocean Spray Drive, Lakeville-Middleboro, MA02349.'}, {'ForeName': 'Robbie S', 'Initials': 'RS', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA70808.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA70808.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'Ocean Spray Cranberries, Inc., One Ocean Spray Drive, Lakeville-Middleboro, MA02349.'}]",The British journal of nutrition,['10.1017/S0007114520001336']
339,32302709,Dietary Therapies Induce Rapid Response and Remission in Pediatric Patients With Active Crohn's Disease.,"BACKGROUND & AIMS
Dietary therapies based on exclusion of usual dietary elements induce remission in children with Crohn's disease (CD), whereas re-exposure induces rebound inflammation. We investigated whether a short trial of dietary therapy, to identify patients with and without a rapid response or remission on the diet (DiRe), can be used to predict success or failure of long-term dietary therapy.
METHODS
We collected data from the multicenter randomized trial of the CD exclusion diet (CDED). We analyzed data from 73 children with mild to moderate CD (mean age, 14.2 ± 2.7 y) randomly assigned to groups given either exclusive enteral nutrition (EEN, n = 34) or the CDED with 50% (partial) enteral nutrition (n = 39). Patients were examined at baseline and at weeks 3 and 6 of the diet. Remission was defined as CD activity index scores below 10 and response was defined as a decrease in score of 12.5 points or clinical remission. Inflammation was assessed by measurement of C-reactive protein.
RESULTS
At week 3 of the diet, 82% of patients in the CDED group and 85% of patients in the EEN group had a DiRe. Median serum levels of C-reactive protein had decreased from 24 mg/L at baseline to 5.0 mg/L at week 3 (P < .001). Among the 49 patients in remission at week 6, 46 patients (94%) had a DiRe and 81% were in clinical remission by week 3. In multivariable analysis, remission at week 3 increased odds of remission by week 6 (odds ratio, 6.37; 95% CI, 1.6-25; P = .008) whereas poor compliance reduced odds of remission at week 6 (odds ratio, 0.75; 95% CI, 0.012-0.46; P = .006).
CONCLUSIONS
For pediatric patients with active CD, dietary therapies (CDED and EEN) induce a rapid clinical response (by week 3). Identification of patients with and without a rapid response to diet might help identify those who, with compliance, will be in clinical remission by week 6 of the diet. ClinicalTrials.gov no: NCT01728870.",2020,"In multivariable analysis, remission at week 3 increased odds of remission by week 6 (odds ratio, 6.37; 95% CI, 1.6-25; P=.008) whereas poor compliance reduced odds of remission at week 6 (odds ratio, 0.75; 95% CI, 0.012-0.46; P=.006).
","[""children with Crohn's disease (CD"", 'pediatric patients with active CD', '73 children with mild to moderate CD (mean age, 14.2±2.7 y', 'patients with and without a rapid response or remission on the diet (DiRe', ""Pediatric Patients With Active Crohn's Disease""]","['dietary therapy', 'CD exclusion diet (CDED', 'dietary therapies (CDED and EEN', 'exclusive enteral nutrition (EEN, n=34) or the CDED with 50% (partial) enteral nutrition']","['Inflammation', 'Median serum levels of C-reactive protein', 'CD activity index scores', 'clinical remission', 'DiRe']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0452376', 'cui_str': 'Elimination diet'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",73.0,0.0844188,"In multivariable analysis, remission at week 3 increased odds of remission by week 6 (odds ratio, 6.37; 95% CI, 1.6-25; P=.008) whereas poor compliance reduced odds of remission at week 6 (odds ratio, 0.75; 95% CI, 0.012-0.46; P=.006).
","[{'ForeName': 'Rotem', 'Initials': 'R', 'LastName': 'Sigall Boneh', 'Affiliation': 'Wolfson Medical Center, Pediatric Gastroenterology, Holon, Israel; The Sackler Faculty of medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Van Limbergen', 'Affiliation': ""Emma Children's Hospital, Amsterdam University Medical Centers - location AMC, Amsterdam, the Netherlands.""}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Wine', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Assa', 'Affiliation': 'The Sackler Faculty of medicine, Tel Aviv University, Tel Aviv, Israel; Schneider Hospital, Petach Tikva, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Shaoul', 'Affiliation': 'Meyer Hospital, Haifa, Israel.'}, {'ForeName': 'Peri', 'Initials': 'P', 'LastName': 'Milman', 'Affiliation': 'Hadassah Hospital, Jerusalem, Israel.'}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': '""Dana-Dwek"" Children\'s Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kori', 'Affiliation': 'Kaplan Hospital, Rehovot, Israel.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Peleg', 'Affiliation': 'HaEmek Hospital, Afula, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'On', 'Affiliation': 'Poriah Hospital, Tiberias, Israel.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Shamaly', 'Affiliation': 'French Hospital, Nazareth, Israel.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Abramas', 'Affiliation': 'Wolfson Medical Center, Pediatric Gastroenterology, Holon, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': 'Wolfson Medical Center, Pediatric Gastroenterology, Holon, Israel; The Sackler Faculty of medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: arie.levine.dr@gmail.com.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.04.006']
340,31439812,Phase I Pharmacokinetic Study of Niraparib in Chinese Patients with Epithelial Ovarian Cancer.,"LESSONS LEARNED
Pharmacokinetics characteristics of niraparib in Chinese patients were similar to those in white patients. Niraparib could be well tolerated by Chinese patients, and adverse events were manageable in this study. Population pharmacokinetics analysis indicated that baseline body weight had a modest impact on pharmacokinetics parameters of niraparib; however, it was not considered clinically important.
BACKGROUND
This randomized, open-label, single-arm, phase I study was designed to investigate the pharmacokinetics (PK) and safety of niraparib in Chinese patients with epithelial ovarian cancer.
METHODS
Eligible patients were randomized in a 1:1:1 ratio to receive 100, 200, or 300 mg of niraparib once daily. PK parameters were analyzed after single and multiple dose administrations.
RESULTS
Thirty-six Chinese patients were enrolled in total. Niraparib was rapidly absorbed after administration, and median time-to-peak (T max ) was 3 hours. The long terminal elimination half-life (T 1/2 ∼ 35 hours) supports once-daily dosing regimen. The exposure to niraparib showed linear and dose-proportional pharmacokinetics, whereas other PK parameters such as T max , T 1/2 , and accumulation ratio were dose independent. Population PK analysis indicated that there was no effect of race on niraparib PK parameters, whereas baseline body weight had a modest impact on niraparib exposure. Grade 3/4 treatment-emergent adverse events (TEAEs; reported in ≥10% of patients) included platelet count decreased (a total of five patients who were all from the 300-mg group) and neutrophil count decreased. The TEAEs were manageable after dose modification.
CONCLUSION
The PK profile of niraparib in Chinese patients is consistent with that in white patients. Niraparib is safe and well tolerated in Chinese patients with ovarian cancer.",2020,"Niraparib was rapidly absorbed after administration, and median time-to-peak (T max ) was 3 hours.","['Chinese Patients with Epithelial Ovarian Cancer', 'Eligible patients', 'Chinese patients with ovarian cancer', 'Chinese patients with epithelial ovarian cancer', 'Thirty-six Chinese patients were enrolled in total', 'Chinese patients']",['Niraparib'],"['niraparib PK parameters', 'pharmacokinetics (PK) and safety of niraparib', 'PK parameters', 'platelet count', 'neutrophil count']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",,0.0839464,"Niraparib was rapidly absorbed after administration, and median time-to-peak (T max ) was 3 hours.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ""Department of Gynecology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Yunong', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Gynecology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Lou', 'Affiliation': ""Department of Gynecology, Harbin Medical University Cancer Hospital, Harbin, People's Republic of China.""}, {'ForeName': 'Rutie', 'Initials': 'R', 'LastName': 'Yin', 'Affiliation': ""Department of Gynecology and Obstetrics, West China Second Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Ji', 'Affiliation': ""Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Gynecology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Bairong', 'Initials': 'B', 'LastName': 'Xia', 'Affiliation': ""Department of Gynecology, Harbin Medical University Cancer Hospital, Harbin, People's Republic of China.""}, {'ForeName': 'Danqing', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Gynecology and Obstetrics, West China Second Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Jianmei', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': ""Department of Research and Development, Zai Lab, Shanghai, People's Republic of China.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Research and Development, Zai Lab, Shanghai, People's Republic of China.""}, {'ForeName': 'Yongjiang', 'Initials': 'Y', 'LastName': 'Hei', 'Affiliation': ""Department of Research and Development, Zai Lab, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhi-Yi', 'Initials': 'ZY', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology, TESARO Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Milton', 'Affiliation': 'Clinical Pharmacology, TESARO Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.""}]",The oncologist,['10.1634/theoncologist.2019-0565']
341,32300382,Pain Relieving Effect of Intraoperative Chemical Splanchnicectomy of Celiac Ganglions in Patients with Resectable Pancreatic or Gastric Masses: A Randomized Clinical Trial.,"Background
Trials of intraoperative chemical splanchnicectomy during resection of pancreatic and gastric masses resulted in significant difference in a patient's postoperative pain. This study aims to determine if splanchnicectomy by alcohol neurolysis can relieve postoperative pain after gastrectomy and Whipple surgery. The study explores differences in outcomes at first four months after surgery.
Methods
Fifty-eight patients with gastric and 60 patients with pancreatic resectable masses were included (28 were lost to follow-up). Each randomized in control and intervention subgroups. Intervention subgroups underwent chemical blockage of celiac ganglions by ethanol injection at both sides of suprapancreatic aorta. Participants were asked to report their pain intensity according to the Visual Analogue Scale (VAS) at specific times.
Result
The overall postoperative pain of injected Whipple and gastrectomy subgroups was lower than the noninjected Whipple and gastrectomy subgroups ( p < 0.001). The pain-modifying effect of the injection was not different between Whipple and gastrectomy groups ( p =0.125).
Conclusion
Splanchnicectomy is recommended for pain reduction after abdominal operations. Perspective . This article presents positive effect of intraoperative chemical splanchnicectomy during resection of pancreatic and gastric masses on postoperative pain. This is an easy, effective, safe, and inexpensive procedure recommended for all operable gastric or pancreatic masses to palliate the pain degree.",2020,"The pain-modifying effect of the injection was not different between Whipple and gastrectomy groups ( p =0.125).
","['Methods\n\n\nFifty-eight patients with gastric and 60 patients with pancreatic resectable masses', 'Patients with Resectable Pancreatic or Gastric Masses', 'after gastrectomy and Whipple surgery']","['Intraoperative Chemical Splanchnicectomy of Celiac Ganglions', 'chemical blockage of celiac ganglions by ethanol injection', 'intraoperative chemical splanchnicectomy', 'splanchnicectomy by alcohol neurolysis', 'Splanchnicectomy']","['overall postoperative pain of injected Whipple and gastrectomy subgroups', 'postoperative pain', 'pain-modifying effect', 'pain intensity according to the Visual Analogue Scale (VAS) at specific times', 'pain reduction']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0196673', 'cui_str': 'Splanchnicectomy'}, {'cui': 'C0007571', 'cui_str': 'Celiac ganglion structure'}, {'cui': 'C4307245', 'cui_str': 'Ethanol Injection'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0196878', 'cui_str': 'Neurolysis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",58.0,0.0557455,"The pain-modifying effect of the injection was not different between Whipple and gastrectomy groups ( p =0.125).
","[{'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Vahedian', 'Affiliation': 'Iran University of Medical Sciences, Firoozgar Hospital, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Saraee', 'Affiliation': 'Iran University of Medical Sciences, Firoozgar Hospital, Tehran, Iran.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Baghai Wadji', 'Affiliation': 'Iran University of Medical Sciences, Firoozgar Hospital, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Safari', 'Affiliation': 'Iran University of Medical Sciences, Firoozgar Hospital, Tehran, Iran.'}, {'ForeName': 'Abdolhamid', 'Initials': 'A', 'LastName': 'Chavoshi Khamneh', 'Affiliation': 'Tehran University of Medical Sciences, Shariati Hospital, Tehran, Iran.'}]",Pain research & management,['10.1155/2020/2675940']
342,32306153,High dietary sodium augments vascular tone and attenuates low-flow mediated constriction in salt-resistant adults.,"INTRODUCTION
Low-flow mediated constriction (L-FMC) has emerged as a valuable and complementary measure of flow-mediated dilation (FMD) for assessing endothelial function non-invasively. High dietary sodium has been shown to impair FMD independent of changes in blood pressure (BP), but its effects on L-FMC are unknown.
PURPOSE
To test the hypothesis that high dietary sodium would attenuate brachial artery L-FMC in salt-resistant adults.
METHODS
Fifteen healthy, normotensive adults (29 ± 6 years) participated in a controlled feeding study. Following a run-in diet, participants completed a 7-day low sodium (LS; 20 mmol sodium/day) and 7-day high sodium (HS; 300 mmol sodium/day) diet in randomized order. On the last day of each diet, 24 h urine was collected and assessments of 24 h ambulatory BP and L-FMC were performed. Salt-resistance was defined as a change in 24 h ambulatory mean arterial pressure (MAP) between the LS and HS diets of ≤ 5 mmHg. Resting vascular tone and L-FMC were calculated from ultrasound-derived arterial diameters.
RESULTS
High dietary sodium increased serum sodium and urinary sodium excretion (p < 0.001 for both), but 24 h MAP was unchanged (p = 0.16) by design. High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008).
CONCLUSION
These findings in salt-resistant adults provide additional evidence that dietary sodium has adverse vascular effects independent of changes in BP.",2020,"High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008).
","['Fifteen healthy, normotensive adults (29\u2009±\u20096\xa0years', 'salt-resistant adults']","['Low-flow mediated constriction (L-FMC', '7-day low sodium (LS; 20\xa0mmol sodium/day) and 7-day high sodium (HS; 300\xa0mmol sodium/day) diet', 'High dietary sodium']","['vascular tone', 'Salt-resistance', 'blood pressure (BP', 'Resting vascular tone and L-FMC', 'ambulatory mean arterial pressure (MAP', 'serum sodium and urinary sodium excretion', 'brachial artery L-FMC']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}]",15.0,0.0307452,"High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008).
","[{'ForeName': 'Ninette', 'Initials': 'N', 'LastName': 'Shenouda', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA. dge@udel.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04370-0']
343,32306762,The effects of a supportive-educational intervention on women with type 2 diabetes and diabetic peripheral neuropathy: a randomized controlled trial.,"PURPOSE
To determine the effect of a supportive educational intervention based on the Orem self-care model on women with type 2 diabetes and diabetic peripheral neuropathy.
DESIGN
A randomized controlled trial.
SETTING
Hospital outpatient diabetes clinic.
SUBJECTS
Adult women with type 2 diabetes and mild-to-moderate diabetic peripheral neuropathy. Out of 410 patients, 120 diabetic patients were recruited and randomly assigned to trial group ( N = 60) and control group ( N = 60).
INTERVENTION
The trial group received a designed intervention consist of one-month supportive educational program with three months of follow-up (totally four months), based on self-care requisites according to the Orem self-care regarding diabetic peripheral neuropathy. The control group only received a routine care program in the diabetes clinic.
MAIN MEASUREMENTS
The main outcomes were symptoms and severity of diabetic neuropathy. Further outcomes were fasting blood sugar and glycosylated hemoglobin.
RESULTS
By the end of the intervention, the number of participants reduced from 60 to 58 in the trial group and to 57 in the control group (totally 115). The intervention significantly decreased mean score of diabetic neuropathy symptoms (trial group: 3.26 vs. control group: 9.57, P = 0.001), severity (trial group: 5.86 vs. control group: 9.02, P = 0.001), fasting blood sugar (trial group: 151 vs. control group: 204, P = 0.001), and glycosylated hemoglobin (trial group: 7.85 vs. control group: 8.62, P = 0.004).
CONCLUSION
Delivering a supportive-educational intervention based on the Orem self-care model on outpatient diabetes clinic can decrease the symptoms and severity of diabetic peripheral neuropathy.
TRIAL REGISTRATION
It was registered in the Iranian Registry of Clinical Trials (IRCT2015021521095N1).",2020,"The intervention significantly decreased mean score of diabetic neuropathy symptoms (trial group: 3.26 vs. control group: 9.57, P = 0.001), severity (trial group: 5.86 vs. control group: 9.02, P = 0.001), fasting blood sugar (trial group: 151 vs. control group: 204, P = 0.001), and glycosylated hemoglobin (trial group: 7.85 vs. control group: 8.62, P = 0.004).
","['women with type 2 diabetes and diabetic peripheral neuropathy', 'Hospital outpatient diabetes clinic', 'Adult women with type 2 diabetes and mild-to-moderate diabetic peripheral neuropathy', '410 patients, 120 diabetic patients']","['supportive-educational intervention', 'designed intervention consist of one-month supportive educational program with three months of follow-up (totally four months), based on self-care requisites according to the Orem self-care regarding diabetic peripheral neuropathy', 'supportive educational intervention', 'routine care program']","['symptoms and severity of diabetic neuropathy', 'mean score of diabetic neuropathy symptoms', 'fasting blood sugar and glycosylated hemoglobin', 'glycosylated hemoglobin']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",410.0,0.0649206,"The intervention significantly decreased mean score of diabetic neuropathy symptoms (trial group: 3.26 vs. control group: 9.57, P = 0.001), severity (trial group: 5.86 vs. control group: 9.02, P = 0.001), fasting blood sugar (trial group: 151 vs. control group: 204, P = 0.001), and glycosylated hemoglobin (trial group: 7.85 vs. control group: 8.62, P = 0.004).
","[{'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Ahrary', 'Affiliation': 'Bohlool Hospital, Gonabad University of Medical Sciences, Gonabad, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Khosravan', 'Affiliation': 'Department of Community Health Nursing & Management Nursing, School of Nursing, Social Determinants of Health Research Center, Gonabad University of Medical Sciences, Gonabad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alami', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Social Determinants of Health Research Center, Gonabad University of Medical Sciences, Gonabad, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Najafi Nesheli', 'Affiliation': 'Department of Medical Sciences, Islamic Azad University, Qom, Iran.'}]",Clinical rehabilitation,['10.1177/0269215520914067']
344,32006721,Nebulized Inhaled Corticosteroids in Asthma Treatment in Children 5 Years or Younger: A Systematic Review and Global Expert Analysis.,"Although nebulized corticosteroids (NebCSs) are a key treatment option for young children with asthma or viral-induced wheezing (VIW), there are no uniform recommendations on their best use. This systematic review aimed to clarify the role of NebCSs in children 5 years or younger for the management of acute asthma exacerbations, asthma maintenance therapy, and the treatment of VIW. Electronic databases were used to identify relevant English language articles with no date restrictions. Studies reporting efficacy data in children 5 years or younger, with a double-blind, placebo- or open-controlled, randomized design, and inclusion of 40 or more participants (no lower patient limit for VIW) were included. Ten articles on asthma exacerbation, 9 on asthma maintenance, and 7 on VIW were identified. Results showed NebCSs to be at least as efficacious as oral corticosteroids in the emergency room for the management of mild to moderate asthma exacerbations. In asthma maintenance, nebulized budesonide, the agent of focus in all trials analyzed, significantly reduced the risk of further asthma exacerbations compared with placebo, cromolyn sodium, and montelukast. Intermittent NebCS treatment of VIW was as effective as continuous daily treatment. In summary, NebCSs are effective and well tolerated in patients 5 years or younger for the management of acute and chronic asthma.",2020,Results showed NebCS to be at least as efficacious as oral corticosteroids in the emergency room (ER) for the management of mild-to-moderate asthma exacerbations.,"['children aged ≤5 years', 'Ten articles on asthma exacerbation, 9 on asthma maintenance, and 7 on VIW were identified', 'Children ≤5 Years of Age', 'patients aged ≤5 years for the management of acute and chronic asthma', '≥40 participants (no lower patient limit for VIW) were included', 'young children with asthma or viral-induced wheezing (VIW', 'children aged ≤5 years for the management of acute asthma exacerbations, asthma maintenance therapy and for the treatment of VIW']","['Nebulized Inhaled Corticosteroids', 'NebCS', 'placebo, cromolyn sodium, and montelukast', 'nebulized budesonide', 'placebo', 'nebulized corticosteroids (NebCS']","['effective and well tolerated', 'risk of further asthma exacerbations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0582415', 'cui_str': 'Acute asthma (disorder)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012694', 'cui_str': 'Cromolyn Sodium'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",,0.16524,Results showed NebCS to be at least as efficacious as oral corticosteroids in the emergency room (ER) for the management of mild-to-moderate asthma exacerbations.,"[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Murphy', 'Affiliation': 'Boys Town National Research Hospital, Omaha, Neb. Electronic address: Kevin.Murphy@boystown.org.'}, {'ForeName': 'Jian Guo', 'Initials': 'JG', 'LastName': 'Hong', 'Affiliation': 'Department of Pediatrics, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Wandalsen', 'Affiliation': 'Division of Allergy and Clinical Immunology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'Larenas-Linnemann', 'Affiliation': 'Hospital Médica Sur Clinical Foundation and Hospital, Mexico City, Mexico.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El Beleidy', 'Affiliation': 'Cairo University, Cairo, Egypt.'}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Zaytseva', 'Affiliation': 'Department of Pediatrics, Moscow State University of Medicine and Dentistry named after A.I. Evdokimov Moscow, Russia.'}, {'ForeName': 'Søren E', 'Initials': 'SE', 'LastName': 'Pedersen', 'Affiliation': 'University of Southern Denmark, Odense, Denmark; Department of Pediatrics, Kolding Hospital, Kolding, Denmark.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.01.042']
345,32095843,Effect of prilocaine and its combination with tramadol on anxiety and pain during nasal packing removal.,"PURPOSE
To investigate the effect of local usage of prilocaine and ıts combination with tramadol on the pain and anxiety levels of patients during nasal packing removal.
METHODS
A total of 117 patients who were treated with the Merocel nasal packing after septoplasty were included in the study. Patients whose Merocel nasal packings infiltrated with prilocaine (P group), prilocaine combined with tramadol 1 mg/kg (P + T1 group), prilocaine combined with tramadol 2 mg/kg (P + T2 group), or normal saline solution (Control group) before nasal packing removal were compared for their pain, sedation, and anxiety related to this removal procedure. The visual analog scale (VAS), Ramsay sedation scale (RSS), and State-Trait Anxiety Inventory (STAI) scale were assessed to evaluate the pain, sedation, and anxiety levels of the patients.
RESULTS
Groups were found similar according to sex, age, and preoperative STAI scores. The VAS score was significantly lower in P, P + T1, and P + T2 than control group during nasal packing removal (p < 0.001, p < 0.001, and p < 0.001, respectively). However, state anxiety inventory (STAI-S) and RSS were found significantly improved only in P + T1 and P + T2 (STAI-S: p = 0.032, RSS: p = 0.002, STAI-S: p = 0.000, RSS: p < 0.001, respectively). In the comparison of P + T1 and P + T2, no significant difference was found in VAS, RSS, and STAI-S (p = 0.604, p = 0.154, and p = 0.264, respectively).
CONCLUSION
The combined infiltration of prilocaine and tramadol 1 mg/kg into the nasal packing is effective in reducing the pain and anxiety of patients during nasal packing removal.",2020,"The VAS score was significantly lower in P, P + T1, and P + T2 than control group during nasal packing removal (p < 0.001, p < 0.001, and p < 0.001, respectively).","['patients during nasal packing removal', '117 patients who were treated with the Merocel nasal packing after septoplasty were included in the study']","['prilocaine combined with tramadol 2\xa0mg/kg (P\u2009+\u2009T2 group), or normal saline solution (Control group) before nasal packing removal', 'prilocaine combined with tramadol', 'prilocaine', 'prilocaine and tramadol', 'tramadol']","['VAS score', 'pain and anxiety levels', 'state anxiety inventory (STAI-S) and RSS', 'pain, sedation, and anxiety levels of the patients', 'anxiety and pain', 'visual analog scale (VAS), Ramsay sedation scale (RSS), and State-Trait Anxiety Inventory (STAI) scale', 'VAS, RSS, and STAI-S ', 'pain and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2699011', 'cui_str': 'Really Simple Syndication'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0222045'}]",117.0,0.0296082,"The VAS score was significantly lower in P, P + T1, and P + T2 than control group during nasal packing removal (p < 0.001, p < 0.001, and p < 0.001, respectively).","[{'ForeName': 'Kamil Gokce', 'Initials': 'KG', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balıkesir University Health Practice and Research Hospital, Cagis, 10440, Balikesir, Turkey. ktulaci@gmail.com.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balıkesir University Health Practice and Research Hospital, Cagis, 10440, Balikesir, Turkey.'}, {'ForeName': 'Rıza Gokcer', 'Initials': 'RG', 'LastName': 'Tulaci', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Hasmet', 'Initials': 'H', 'LastName': 'Yazici', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balıkesir University Health Practice and Research Hospital, Cagis, 10440, Balikesir, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-05863-6']
346,31423921,Epoetin Beta and C-Terminal Fibroblast Growth Factor 23 in Patients With Chronic Heart Failure and Chronic Kidney Disease.,"Background In patients with chronic heart failure and chronic kidney disease, correction of anemia with erythropoietin-stimulating agents targeting normal hemoglobin levels is associated with an increased risk of cardiovascular morbidity and mortality. Emerging data suggest a direct effect of erythropoietin on fibroblast growth factor 23 (FGF23), elevated levels of which have been associated with adverse outcomes. We investigate effects of erythropoietin-stimulating agents in patients with both chronic heart failure and chronic kidney disease focusing on FGF23. Methods and Results In the EPOCARES (Erythropoietin in CardioRenal Syndrome) study, we randomized 56 anemic patients (median age 74 [interquartile range 69-80] years, 66% male) with both chronic heart failure and chronic kidney disease into 3 groups, of which 2 received epoetin beta 50 IU/kg per week for 50 weeks, and the third group served as control. Measurements were performed at baseline and after 2, 26, and 50 weeks. Data were analyzed using linear mixed-model analysis. After 50 weeks of erythropoietin-stimulating agent treatment, hematocrit and hemoglobin levels increased. Similarly, C-terminal FGF23 levels, in contrast to intact FGF23 levels, rose significantly due to erythropoietin-stimulating agents as compared with the controls. During median follow-up for 5.7 (2.0-5.7) years, baseline C-terminal FGF23 levels were independently associated with increased risk of mortality (hazard ratio 2.20; 95% CI, 1.35-3.59; P=0.002). Conclusions Exogenous erythropoietin increases C-terminal FGF23 levels markedly over a period of 50 weeks, elevated levels of which, even at baseline, are significantly associated with an increased risk of mortality. The current results, in a randomized trial setting, underline the strong relationship between erythropoietin and FGF23 physiology in patients with chronic heart failure and chronic kidney disease. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00356733.",2019,"Conclusions Exogenous erythropoietin increases C-terminal FGF23 levels markedly over a period of 50 weeks, elevated levels of which, even at baseline, are significantly associated with an increased risk of mortality.","['patients with chronic heart failure and chronic kidney disease', '56 anemic patients (median age 74 [interquartile range 69-80] years, 66% male) with both chronic heart failure and chronic kidney disease into 3 groups, of which 2 received', 'patients with chronic heart failure and chronic kidney disease, correction of anemia with erythropoietin-stimulating agents targeting normal hemoglobin levels', 'Patients With Chronic Heart Failure and Chronic Kidney Disease', 'patients with both chronic heart failure and chronic kidney disease focusing on FGF23']","['erythropoietin', 'Epoetin Beta and C-Terminal Fibroblast Growth Factor 23', 'erythropoietin-stimulating agents', 'epoetin beta 50\xa0IU/kg per week for 50\xa0weeks, and the third group served as control']","['hematocrit and hemoglobin levels', 'C-terminal FGF23 levels', 'risk of mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0357131', 'cui_str': 'epoetin beta'}, {'cui': 'C1829744', 'cui_str': 'Fibroblast growth factor, C-terminal'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",56.0,0.0316504,"Conclusions Exogenous erythropoietin increases C-terminal FGF23 levels markedly over a period of 50 weeks, elevated levels of which, even at baseline, are significantly associated with an increased risk of mortality.","[{'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Eisenga', 'Affiliation': 'Division of Nephrology Department of Internal Medicine University of Groningen University Medical Center Groningen Groningen the Netherlands.'}, {'ForeName': 'Mireille E', 'Initials': 'ME', 'LastName': 'Emans', 'Affiliation': 'Department of Cardiology Ikazia Hospital Rotterdam the Netherlands.'}, {'ForeName': 'Karien', 'Initials': 'K', 'LastName': 'van der Putten', 'Affiliation': 'Department of Nephrology Tergooi Hospital Hilversum the Netherlands.'}, {'ForeName': 'Maarten J', 'Initials': 'MJ', 'LastName': 'Cramer', 'Affiliation': 'Department of Cardiology University of Utrecht University Medical Center Utrecht Utrecht the Netherlands.'}, {'ForeName': 'Adry', 'Initials': 'A', 'LastName': 'Diepenbroek', 'Affiliation': 'Division of Nephrology Department of Internal Medicine University of Groningen University Medical Center Groningen Groningen the Netherlands.'}, {'ForeName': 'Birgitta K', 'Initials': 'BK', 'LastName': 'Velthuis', 'Affiliation': 'Department of Radiology University of Utrecht University Medical Center Utrecht Utrecht the Netherlands.'}, {'ForeName': 'Pieter A', 'Initials': 'PA', 'LastName': 'Doevendans', 'Affiliation': 'Department of Cardiology University of Utrecht University Medical Center Utrecht Utrecht the Netherlands.'}, {'ForeName': 'Marianne C', 'Initials': 'MC', 'LastName': 'Verhaar', 'Affiliation': 'Department of Nephrology and Hypertension University of Utrecht University Medical Center Utrecht Utrecht the Netherlands.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension University of Utrecht University Medical Center Utrecht Utrecht the Netherlands.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Division of Nephrology Department of Internal Medicine University of Groningen University Medical Center Groningen Groningen the Netherlands.'}, {'ForeName': 'Ilja M', 'Initials': 'IM', 'LastName': 'Nolte', 'Affiliation': 'Department of Epidemiology University of Groningen University Medical Center Groningen Groningen the Netherlands.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Braam', 'Affiliation': 'Division of Nephrology and Immunology Department of Medicine University of Alberta Edmonton Canada.'}, {'ForeName': 'Carlo A J M', 'Initials': 'CAJM', 'LastName': 'Gaillard', 'Affiliation': 'Department of Internal Medicine and Dermatology University of Utrecht University Medical Center Utrecht Utrecht the Netherlands.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.011130']
347,32307251,"Pasireotide administration after pancreaticoduodenectomy may decrease clinically relevant postoperative pancreatic fistula in high-risk patients with small pancreatic ducts, soft pancreatic parenchyma and cystic or neuroendocrine neoplasia.","OBJECTIVES
Post-operative pancreatic fistula (POPF) is a feared complication after a pancreaticoduodenectomy. Previously in a randomized trial found fewer clinically relevant fistulas (CR-POPF) accompanying administration of perioperative pasireotide. Our hospital previously found that the risk for CR-POPF reached 7% in pancreaticoduodenectomy patients. Here, we aimed to determine the CR-POPF rate accompanying prophylactic pasireotide in patients with a normal pancreas at resection level.
METHODS
In this clinical study, perioperative pasireotide was administered to pancreaticoduodenectomy patients treated between 1 July 2014 and 30 April 2016. High-risk individuals were defined preoperatively by the surgeon based on the following: no dilatation of the pancreatic duct, suspected soft pancreas and a cystic or neuroendocrine tumor at the head of the pancreas. If the pancreas was considered hard at surgery, thereby carrying a lower risk for fistula, pasireotide was discontinued following one preoperative 900-μg dose. Among high-risk patients, pasireotide was continued for one week or until discharge from the hospital.
RESULTS
During the study period, 153/215 pancreatic operations were pancreaticoduodenectomies, 58 (38%) of which were considered high risk for developing clinically significant pancreatic fistula. Among these, 4 (2.6%) developed a grade B or C fistula: 2 in the pasireotide group [3.5%, 95% confidence interval (CI) 0.4-11.9%], 1 in the low-risk group (1.2%, 95% CI 0.0-6.4%; difference: 2.3%, 95% CI -6.4-17.3%) and 1 in the discontinued group (10%).
CONCLUSION
We found similar rates of CR-POPF among high- and low-risk patients undergoing pancreaticoduodenectomy when using prophylactic perioperative pasireotide in high-risk patients.",2020,We found similar rates of CR-POPF among high- and low-risk patients undergoing pancreaticoduodenectomy when using prophylactic perioperative pasireotide in high-risk patients.,"['high-risk patients', 'patients treated between 1 July 2014 and 30 April 2016', 'high-risk patients with small pancreatic ducts, soft pancreatic parenchyma and cystic or neuroendocrine neoplasia', 'patients with a normal pancreas at resection level']","['pancreaticoduodenectomy', 'Pasireotide administration after pancreaticoduodenectomy']","['rates of CR-POPF', 'grade B or C fistula', 'CR-POPF rate accompanying prophylactic pasireotide', 'CR-POPF']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0441806', 'cui_str': 'Grade B'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]",,0.105048,We found similar rates of CR-POPF among high- and low-risk patients undergoing pancreaticoduodenectomy when using prophylactic perioperative pasireotide in high-risk patients.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vuorela', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. Electronic address: tiina.a.vuorela@hus.fi.'}, {'ForeName': 'Mustonen', 'Initials': 'M', 'LastName': 'Harri', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kokkola', 'Initials': 'K', 'LastName': 'Arto', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Haglund', 'Initials': 'H', 'LastName': 'Caj', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Seppänen', 'Initials': 'S', 'LastName': 'Hanna', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.03.010']
348,32147873,Application of inter-professional care model in patients with aneurysmal subarachnoid haemorrhage.,"OBJECTIVE
To explore the feasibility and effect of the inter-professional care model in patients with aneurysmal subarachnoid haemorrhage.
METHODS
A convenient sampling method was used to recruit inpatients of a hospital as subjects from July 2016 to July 2018. According to the even/odd attribute of admission number, subjects were divided into a control group and an observation group. The number of recruited subjects was 311: the control group comprised 135 participants and the observation group 176. The average length of hospital stay, hospital fees, quality of life, and satisfaction with the quality of nursing were compared between the two groups. SPIRIT checklist was completed (see File S1).
RESULTS
After intervention, patients in the observation group had shorter average hospital stay (15.98 ± 2.7), lower hospital fees (81,018 ± 1.3), higher satisfaction with the quality of nursing (98.3%), lower incidence of complications (19.89%), improved ability to perform activities of daily living, and lower rate of disease outcome and re-admission, with statistically significant differences from the control group (p < .05).
CONCLUSION
The application of inter-professional care model in single disease patients with aneurysmal subarachnoid haemorrhage can shorten the average hospital stay, reduce hospital fees, improve the quality of life of patients, and increase patients' satisfaction with the quality of nursing, which is worthy of clinical promotion and application.
IMPLICATIONS FOR NURSING MANAGEMENT SECTION
Nursing managers can use this model to improve the ability to ensure coordination between medical professionals and integrate the ability of nursing problems, the ability to make rational distribution of nursing human resources, and the ability of critical thinking. It can be used as reference to improve the nursing management of all kinds of single diseases.",2020,"After intervention, patients in the observation group had shorter average hospital stay (15.98±2.7), lower hospital fees (81018±1.3), higher satisfaction with the quality of nursing (98.3%), lower incidence of complications (19.89%), improved ability to perform activities of daily living , and lower rate of disease outcome and re-admission, with statistically significant differences from the control group (p < 0.05).
","['patients with aneurysmal subarachnoid hemorrhage', 'single disease patients with aneurysmal subarachnoid hemorrhage', 'recruit inpatients of a hospital as subjects from July 2016 to July 2018', '176']",['observation group'],"['incidence of complications', 'lower hospital fees', 'ability to perform activities of daily living , and lower rate of disease outcome and re-admission', 'average length of hospital stay, hospital fees, quality of life, and satisfaction with the quality of nursing', 'shorter average hospital stay', 'higher satisfaction with the quality of nursing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0158111,"After intervention, patients in the observation group had shorter average hospital stay (15.98±2.7), lower hospital fees (81018±1.3), higher satisfaction with the quality of nursing (98.3%), lower incidence of complications (19.89%), improved ability to perform activities of daily living , and lower rate of disease outcome and re-admission, with statistically significant differences from the control group (p < 0.05).
","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Shanxi People's Hospital, Taiyuan, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Graduate School of Shanxi, University of Traditional Chinese Medicine, Taiyuan, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Shanxi People's Hospital, Taiyuan, China.""}]",Journal of nursing management,['10.1111/jonm.12993']
349,32200051,What type of exercise is most effective for people with knee osteoarthritis and co-morbid obesity?: The TARGET randomized controlled trial.,"OBJECTIVE
Different exercise types may yield different outcomes in osteoarthritis (OA) subgroups. The objective was to directly compare effectiveness of two exercise programs for people with medial knee OA and co-morbid obesity.
DESIGN
We performed a participant- and assessor-blinded randomized controlled trial. 128 people ≥50 years with medial knee OA and body mass index ≥30 kg/m 2 were recruited from the community. Interventions were home-based non-weight bearing (NWB) quadriceps strengthening or weight bearing (WB) functional exercise for 12 weeks. Primary outcomes were change in overall knee pain (numeric rating scale, range 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 12 weeks. Secondary outcomes included other pain measures, physical function, quality-of-life, global changes, physical performance, and lower-limb muscle strength.
RESULTS
123 (96%) participants were retained. There was no evidence of a between-group difference in change in pain (mean difference 0.73 units (95% confidence intervals (0.05,1.50)) or function (2.80 units (-1.17,6.76)), with both groups reporting improvements. For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98). Although adverse events were minor, more NWB group participants reported ≥1 adverse event (26/66 (39%) vs 14/62 (23%), p = 0.04).
CONCLUSIONS
Both exercise types similarly improved primary outcomes of pain and function and can be recommended for people with knee OA and obesity. WB exercise may be preferred given fewer adverse events and potential additional benefits on some secondary outcomes.
REGISTRATION
Prospectively registered (Australian New Zealand Clinical Trials Registry #12617001013358, 14/7/2017).",2020,"For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98).","['123 (96', 'OA subgroups', 'people with knee OA and obesity', 'people with medial knee OA and co-morbid obesity', '128 people ≥50 years with medial knee OA and body mass index ≥30 kg/m 2 were recruited from the community', 'people with knee osteoarthritis and co-morbid obesity']","['WB exercise', 'exercise programs', 'home-based non-weight bearing (NWB) quadriceps strengthening or weight bearing (WB) functional exercise']","['overall knee pain (numeric rating scale, range 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68', 'adverse events', 'quality-of-life', 'adverse event', 'pain and function', 'change in pain', 'pain measures, physical function, quality-of-life, global changes, physical performance, and lower-limb muscle strength']","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing (finding)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",128.0,0.215058,"For secondary outcomes, the WB group had greater improvement in quality-of-life (-0.043 units (-0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98).","[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: k.bennell@unimelb.edu.au.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Nelligan', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: rachel.nelligan@unimelb.edu.au.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Kimp', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: alexander.kimp@unimelb.edu.au.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: sarah.schwartz@unimelb.edu.au.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia. Electronic address: jessica.kasza@monash.edu.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Wrigley', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: timw@unimelb.edu.au.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Metcalf', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: b.metcalf@unimelb.edu.au.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Hodges', 'Affiliation': 'The University of Queensland, Centre for Clinical Research Excellence in Spinal Pain, Injury and Health, School of Health and Rehabilitation Sciences, QLD, Australia. Electronic address: p.hodges@uq.edu.au.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'The University of Melbourne, Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Melbourne, VIC, Australia. Electronic address: ranash@unimelb.edu.au.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.02.838']
350,31129681,Maternal anemia type during pregnancy is associated with anemia risk among offspring during infancy.,"BACKGROUND
We evaluated the association between etiology of maternal anemia and iron status throughout infancy.
METHODS
Samples from a study designed to examine Praziquantel treatment during pregnancy were used (n = 359). All women were infected with schistosomiasis and randomized to Praziquantel or placebo at 16 ± 2 weeks' gestation. Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood. The relationship between both maternal Praziquantel treatment and etiology of anemia and infant iron status was evaluated.
RESULTS
Maternal iron-deficiency anemia was associated with increased risk of infant anemia at 6 months of age. Infants of mothers with the lowest levels of circulating hepcidin during gestation, likely a marker for iron deficiency, had higher sTfR:SF levels and lower hemoglobin levels, particularly at 12 months of age. Maternal non-iron-deficiency anemia (NIDA) did not impact infant anemia risk or iron status. Maternal treatment for schistosomiasis had no effect on infant hematologic status.
CONCLUSIONS
Maternal iron deficiency anemia was associated with an increased risk for anemia or iron deficiency during late infancy. We did not observe an association between maternal NIDA and increased risk for iron deficiency during infancy.",2019,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.",['All women were infected with schistosomiasis and randomized to'],"['Praziquantel or placebo', 'Praziquantel']","['sTfR', 'SF levels and lower hemoglobin levels', 'risk of infant anemia', 'Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6', 'Maternal anemia type', 'etiology of anemia and infant iron status', 'Maternal iron-deficiency anemia', 'Maternal non-iron-deficiency anemia (NIDA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}]",,0.133641,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.","[{'ForeName': 'Ajibola I', 'Initials': 'AI', 'LastName': 'Abioye', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'McDonald', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sangshin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA. spark@uos.ac.kr.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ripp', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Bennett', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hannah W', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sunthorn', 'Initials': 'S', 'LastName': 'Pond-Tor', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Sagliba', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Amabelle J', 'Initials': 'AJ', 'LastName': 'Amoylen', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Palmera I', 'Initials': 'PI', 'LastName': 'Baltazar', 'Affiliation': 'Remedios Trinidad Romualdez Hospital, Tacloban City, Leyte, The Philippines.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kurtis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Pediatric research,['10.1038/s41390-019-0433-5']
351,32301681,Changes in countermovement jump performance and subjective readiness-to-train scores following a simulated soccer match.,"The study investigated whether countermovement jump (CMJ) metrics and subjective responses to a readiness-to-train questionnaire (RTT-Q) tracked simulated match-induced acute fatigue. This was a randomized cross-over repeated measures study. Participants were assigned into one of two groups; CONTROL or LIST. The LIST group performed the Loughborough Intermittent Shuttle Run (LIST), which was designed to simulate the demands of a soccer match. The CONTROL performed light physical activity at an intensity of <65% of maximal heart rate. Each group performed three CMJ's and completed an RTT-Q before (PRE), and again at 24 and 48 h after the LIST and/or CONTROL interventions. At 24 h there were significant differences in RTT-Q answers between the Pre and 24 h for the LIST group for questions; ""Do you feel physically strong today?"" and ""Do you have muscle soreness today?"" ( p = 0.02 and 0.0008, respectively). The questions ""Do you feel mentally strong today?"" and "" Do you have muscle soreness today ?"" ( p = 0.02 and p = 0.0001 respectively) were the only questions that had a significant difference between Pre and 48 h for the LIST group. None of the CMJ metrics (LIST or CONTROL) changed significantly at any stage of the experiment. Although fatigue was detected by changes in the RTT-Q at 24 and 48 h after the LIST, none of the CMJ metrics changed. These findings suggest that subjective measures are more sensitive to low-level fatigue than objective measures, thus effective monitoring should include both.",2020,"At 24 h there were significant differences in RTT-Q answers between the Pre and 24 h for the LIST group for questions; "" Do you feel physically strong today ?"" and "" Do you have muscle soreness today ?""",[],"['countermovement jump (CMJ) metrics and subjective responses to a readiness-to-train questionnaire (RTT-Q', 'Loughborough Intermittent Shuttle Run (LIST', 'LIST']","['RTT-Q answers', 'countermovement jump performance and subjective readiness-to-train scores']",[],"[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.043078,"At 24 h there were significant differences in RTT-Q answers between the Pre and 24 h for the LIST group for questions; "" Do you feel physically strong today ?"" and "" Do you have muscle soreness today ?""","[{'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Lombard', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Starling', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wewege', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lambert', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}]",European journal of sport science,['10.1080/17461391.2020.1757764']
352,32298717,Acceptability of oral dimethandrolone undecanoate in a 28-day placebo-controlled trial of a hormonal male contraceptive prototype.,"OBJECTIVE
To determine men's satisfaction with and acceptability of a once-daily, oral regimen of dimethandrolone undecanoate (DMAU) versus placebo when used for 28 days.
STUDY DESIGN
After a Phase I double-blind, randomized, placebo-controlled, dose-escalating trial of oral DMAU for 28-days, 57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen. In the trial, participants were randomized to receive up to 4 DMAU capsules daily versus placebo and instructed to ingest them within 30 min of consuming a high fat meal. Pharmacokinetic and pharmacodynamic profiles were performed, followed by a 6-week recovery phase. Participants were counseled that they could not rely on the drug for contraception.
RESULTS
Fifty-seven participants were offered acceptability surveys (39 DMAU, 18 placebo). Most respondents, 80% (45/56), reported satisfaction with the method; 77% (44/57) would recommend it. 54% (31/57), reported that, if available, they would use the method as their primary contraceptive. More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p = 0.05). Most respondents, 91% (52/57), reported no difficulty with having to take up to 4 pills within 30 min of ingesting a high-fat meal.
CONCLUSION
Most participants reported that the study method, daily oral DMAU or placebo, was satisfactory and acceptable. Having to take the drug after a high-fat meal did not detract from acceptability.
IMPLICATIONS
Most participants in a 4-week trial of daily DMAU capsules would recommend and use the method. High satisfaction among DMAU and placebo groups affirms acceptability of a daily male contraceptive pill, warranting further study of oral DMAU.",2020,More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p=0.05).,"['hormonal male contraceptive prototype', '57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen', 'Participants were counseled that they could not rely on the drug for contraception', 'Fifty-seven participants']","['oral dimethandrolone undecanoate', 'DMAU capsules daily versus placebo', 'placebo', 'oral DMAU', 'dimethandrolone undecanoate (DMAU) versus placebo', 'DMAU and placebo']",['satisfaction with active DMAU'],"[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009881', 'cui_str': 'Contraceptives, Male'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2974168', 'cui_str': 'dimethandrolone-undecanoate'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2974168', 'cui_str': 'dimethandrolone-undecanoate'}]",57.0,0.422798,More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p=0.05).,"[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Obstetrics & Gynecology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA; The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA. Electronic address: nguyenbt@usc.edu.'}, {'ForeName': 'Maritza T', 'Initials': 'MT', 'LastName': 'Farrant', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Anawalt', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Yuen', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Arthi', 'Initials': 'A', 'LastName': 'Thirumalai', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Amory', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Bremner', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}]",Contraception,['10.1016/j.contraception.2020.04.006']
353,32302665,Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial.,"AIMS
Hypoglycemia is one of the most important complications associated with Ramadan fasting in people with type 2 diabetes. LixiRam (NCT02941367) was the first randomized trial comparing safety and efficacy of lixisenatide + basal insulin (BI) vs. sulphonylurea + BI in people with type 2 diabetes who fast during Ramadan. This post hoc analysis focuses on the LixiRam study population from India.
METHODS
Adults with type 2 diabetes insufficiently controlled with sulphonylurea + BI ± another oral anti-hyperglycemic drug were randomized 1:1 to receive lixisenatide + BI or to continue sulphonylurea + BI treatment.
RESULTS
In total, 150 participants were randomized in India. One participant (1.3%) with lixisenatide + BI vs. 5 participants (6.8%) with sulphonylurea + BI experienced ≥1 documented symptomatic hypoglycemic event during the Ramadan fast (odds ratio [OR]: 0.22; 95% confidence interval [CI]: 0.02-1.93). Incidence of any hypoglycemia was numerically lower with lixisenatide + BI vs. sulphonylurea + BI during Ramadan fasting (1.3% [1/75] vs. 14.7% [11/75], respectively; OR: 0.09; 95% CI: 0.01-0.69). No new safety signals were identified.
CONCLUSIONS
A combination of lixisenatide prandial GLP1-RA + BI may be a suitable treatment option for people with type 2 diabetes who elect to fast during Ramadan. Clinical Trial Registry: clinicaltrials.gov (NCT02941367).",2020,Incidence of any hypoglycemia was numerically lower with lixisenatide + BI vs. sulphonylurea + BI during Ramadan fasting (1.3% [1/75],"['people with type 2 diabetes who fast during Ramadan', 'Indian people with type 2 diabetes mellitus during Ramadan fast', 'Adults with type 2 diabetes insufficiently controlled with sulphonylurea + BI ± another oral anti-hyperglycemic drug', 'people with type 2 diabetes', '150 participants were randomized in India', 'people with type 2 diabetes who elect to fast during Ramadan']","['lixisenatide + basal insulin (BI) vs. sulphonylurea + BI', 'lixisenatide prandial GLP1-RA + BI', 'lixisenatide + BI vs. sulphonylurea + BI', 'lixisenatide plus basal insulin treatment regimen', 'lixisenatide + BI or to continue sulphonylurea + BI treatment']","['symptomatic hypoglycemic event', 'Incidence of any hypoglycemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C2350813', 'cui_str': 'EHMT1 protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",150.0,0.0907296,Incidence of any hypoglycemia was numerically lower with lixisenatide + BI vs. sulphonylurea + BI during Ramadan fasting (1.3% [1/75],"[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Sahay', 'Affiliation': 'Department of Endocrinology, Osmania Medical College, Hyderabad, India. Electronic address: sahayrk@gmail.com.'}, {'ForeName': 'Khadijah', 'Initials': 'K', 'LastName': 'Hafidh', 'Affiliation': 'Rashid Hospital, Dubai, United Arab Emirates.'}, {'ForeName': 'Khier', 'Initials': 'K', 'LastName': 'Djaballah', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Coudert', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Azar', 'Affiliation': 'American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Shehadeh', 'Affiliation': 'Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Hanif', 'Affiliation': 'University Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hassanein', 'Affiliation': 'Dubai Hospital, Dubai, United Arab Emirates.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108148']
354,31396983,Polyethylene glycol loxenatide (PEX168) in subjects with renal impairment: A pharmacokinetic study.,"AIMS
Type 2 diabetes mellitus (T2DM) is commonly complicated by renal impairment. Polyethylene glycol loxenatide (PEX168) is a novel long-acting glucagon-like peptide-1 receptor agonist for T2DM. PEX168 pharmacokinetics was studied to identify requirements for dose-modification in T2DM complicated by renal impairment.
METHODS
This was a single-centre, open-labelled, parallel-group, single-dose, phase I clinical trial of patients with mild and moderate renal impairment, and with or without T2DM. Age-, sex- and body mass index-matched subjects with normal renal function, and with or without T2DM were recruited as controls. Subjects received a single abdominal subcutaneous injection of PEX168 200 μg. Pharmacokinetic samples were taken at 0, 24, 48, 72, 96, 120, 144, 216, 312, 480, 648 and 720 hours.
RESULTS
Twenty-three patients were included in the pharmacokinetics analysis. Vz/F and CL/F were lower in the moderate impairment group than in the other groups. The mean t 1/2 (163 hours) in the moderate impairment group was prolonged compared to the mild impairment (117 hours) and normal (121 hours) groups. AUC 0-inf increased by 13 and 100.7% in patients with mild and moderate renal impairment, respectively. Most adverse events were mild gastrointestinal disorders, with only 1 serious adverse event observed.
CONCLUSION
A single dose of 200 μg of PEX168 was in general well tolerated in patients with renal impairment. The in vivo clearance rate of PEX168 in patients with moderate renal impairment is slower than in patients with mild renal impairment and normal renal function and dose adjustment might be required (ClinicalTrials.org #NCT02467790).",2019,Vz/F and CL/F were lower in the moderate impairment group than in the other groups.,"['patients with mild and moderate renal impairment, and with or without T2DM', 'subjects with renal impairment', 'patients with renal impairment', 'Twenty-three patients were included in the pharmacokinetics analysis', 'Age-, sex-, and body mass index (BMI)-matched subjects with normal renal function, and with or without T2DM were recruited as controls', 'patients with moderate renal impairment', 'patients with mild and moderate renal impairment']","['PEX168 pharmacokinetics (PK', 'Polyethylene glycol loxenatide (PEX168', 'PEX168']","['AUC 0-inf', 'Vz/F and CL/F']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4079755', 'cui_str': 'PEX168'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4077947', 'cui_str': 'polyethylene glycol loxenatide'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.0813867,Vz/F and CL/F were lower in the moderate impairment group than in the other groups.,"[{'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xianming', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yi', 'Affiliation': 'Department of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jishi', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xingfei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",British journal of clinical pharmacology,['10.1111/bcp.14091']
355,32198079,Improved monitoring of adherence with patching treatment using a microsensor and Eye Patch Assistant.,"BACKGROUND
Use of a microsensor has been suggested to monitor patching adherence. Application has been limited because the microsensor's small size makes it easy to lose and a swallowing risk. We designed the Eye Patch Assistant (EPA) to hold the small microsensor in place and reduce the risk of loss or swallowing. This study reports the accuracy, precision, ease of use, and comfort for patching with EPA (patch+EPA) to monitor adherence.
METHODS
Adults (N = 13) wore an adhesive patch alone or a patch+EPA for 2 hours each, recorded wear time, and completed an ease of use/comfort questionnaire; 30 children wore a patch or patch+EPA and completed the questionnaire. Sensor sampling interval was every 5 minutes or every 1 minute. Sensor accuracy and precision were evaluated by Bland-Altman analysis and 95% limits of agreement, and questionnaire scores compared by Wilcoxon tests.
RESULTS
With 5-minute sampling, we found excellent accuracy for adults (mean actual vs recorded time difference, 1.4 minutes) and children (mean difference, -0.9 min). We found high precision for both adults and children (95% limits of agreement half widths of 6.4 minutes and 1.9 minutes, respectively). In adults, the ease of use score for the patch+EPA was lower than the patch (P < 0.01), but the comfort score for the patch+EPA was higher (P < 0.01). For children, scores did not differ significantly. The patch+EPA functioned well between 45° and 82°F.
CONCLUSIONS
The patch+EPA was well accepted and monitored adherence accurately and precisely.",2020,"In adults, the ease of use score for the patch+EPA was lower than the patch (P < 0.01), but the comfort score for the patch+EPA was higher (P < 0.01).",['Adults (N = 13) wore an'],"['Eye Patch Assistant (EPA', 'adhesive patch alone or a patch+EPA for 2 hours each, recorded wear time, and completed an ease of use/comfort questionnaire; 30 children wore a patch or patch+EPA']","['comfort score', 'risk of loss or swallowing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}]",,0.0380849,"In adults, the ease of use score for the patch+EPA was lower than the patch (P < 0.01), but the comfort score for the patch+EPA was higher (P < 0.01).","[{'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Salus University Pennsylvania College of Optometry, Elkins Park, Pennsylvania. Electronic address: jingyun.wang@gmail.com.'}, {'ForeName': 'Hongxin', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Panorama Windows Ltd. New York, New York.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'De La Cruz', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Morale', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Leske', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2020.01.006']
356,31718297,Baseline Predictors of Low-Density Lipoprotein Cholesterol and Systolic Blood Pressure Goal Attainment After 1 Year in the ISCHEMIA Trial.,"BACKGROUND
Risk factor control is the cornerstone of managing stable ischemic heart disease but is often not achieved. Predictors of risk factor control in a randomized clinical trial have not been described.
METHODS AND RESULTS
The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) randomized individuals with at least moderate inducible ischemia and obstructive coronary artery disease to an initial invasive or conservative strategy in addition to optimal medical therapy. The primary aim of this analysis was to determine predictors of meeting trial goals for LDL-C (low-density lipoprotein cholesterol, goal <70 mg/dL) or systolic blood pressure (SBP, goal <140 mm Hg) at 1 year post-randomization. We included all randomized participants in the ISCHEMIA trial with baseline and 1-year LDL-C and SBP values by January 28, 2019. Among the 3984 ISCHEMIA participants (78% of 5179 randomized) with available data, 35% were at goal for LDL-C, and 65% were at goal for SBP at baseline. At 1 year, the percent at goal increased to 52% for LDL-C and 75% for SBP. Adjusted odds of 1-year LDL-C goal attainment were greater with older age (odds ratio [OR], 1.11 [95% CI, 1.03-1.20] per 10 years), lower baseline LDL-C (OR, 1.19 [95% CI, 1.17-1.22] per 10 mg/dL), high-intensity statin use (OR, 1.30 [95% CI, 1.12-1.51]), nonwhite race (OR, 1.32 [95% CI, 1.07-1.63]), and North American enrollment compared with other regions (OR, 1.32 [95% CI, 1.06-1.66]). Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]). Adjusted odds of 1-year SBP goal attainment were greater with lower baseline SBP (OR, 1.27 [95% CI, 1.22-1.33] per 10 mm Hg) and with North American enrollment (OR, 1.35 [95% CI, 1.04-1.76]).
CONCLUSIONS
In ISCHEMIA, older age, male sex, high-intensity statin use, lower baseline LDL-C, and North American location predicted 1-year LDL-C goal attainment, whereas lower baseline SBP and North American location predicted 1-year SBP goal attainment. Future studies should examine the effects of sex disparities, international practice patterns, and provider behavior on risk factor control.",2019,"Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]).",['individuals with at least moderate inducible ischemia and obstructive coronary artery disease to an initial invasive or conservative strategy in addition to optimal medical therapy'],"['LDL-C (low-density lipoprotein cholesterol, goal <70 mg/dL']","['1-year SBP goal attainment', 'Low-Density Lipoprotein Cholesterol and Systolic Blood Pressure Goal Attainment', '1-year LDL-C goal', '1-year LDL-C goal attainment', 'systolic blood pressure']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",5179.0,0.447978,"Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]).","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': 'New York University School of Medicine (J.D.N., J.S.H.).'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., X.G., S.M.O.).'}, {'ForeName': 'Xiangqiong', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., X.G., S.M.O.).'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., X.G., S.M.O.).'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA New England Healthcare System, Boston, MA (W.E.B.).'}, {'ForeName': 'Sajeev C', 'Initials': 'SC', 'LastName': 'Govindan', 'Affiliation': 'Government Medical College, Kerala, India (S.C.G.).'}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, United Kingdom (R.S.).'}, {'ForeName': 'Nagaraja', 'Initials': 'N', 'LastName': 'Moorthy', 'Affiliation': 'Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, Karnataka, India (N.M.).'}, {'ForeName': 'Paulo C', 'Initials': 'PC', 'LastName': 'Rezende', 'Affiliation': 'Heart Instituto do Coracao, University of Sao Paulo, Brazil (P.C.R.).'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': 'Coronary and Structural Heart Diseases Department, Institute of Cardiology, Warsaw, Poland (M.D.).'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz, Idipaz, Madrid, Spain (J.L.L.-S.).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': 'National Research Center for Cardiovascular Surgery, Moscow, Russia (O.B.).'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Pandit', 'Affiliation': 'Ram Manohar Lohia Hospital, Delhi, India (N.P.).'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': 'Montreal Heart Institute, QC, Canada (G.G.).'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Stone', 'Affiliation': ""Brigham and Women's Hospital, MA (P.H.S.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Saint Luke's Mid America Heart Institute/UMKC, MO (J.A.S.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Columbia University Medical Center and the Cardiovascular Research Foundation, NY (J.W.S.).'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Institute of Health, NHLBI, MD (J.L.F.).'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'New York University School of Medicine (J.D.N., J.S.H.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Stanford University School of Medicine, CA (D.J.M.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006002']
357,32244111,Glucocorticoids and cortical decoding in the phobic brain.,"Glucocorticoids reduce phobic fear in anxiety disorders and enhance psychotherapy, possibly by reducing the retrieval of fear memories and enhancing the consolidation of new corrective memories. Glucocorticoid signaling in the basolateral amygdala can influence connected fear and memory-related cortical regions, but this is not fully understood. Previous studies investigated specific pathways moderated by glucocorticoids, for example, visual-temporal pathways; however, these analyses were limited to a-priori selected regions. Here, we performed whole-brain pattern analysis to localize phobic stimulus decoding related to the fear-reducing effect of glucocorticoids. We reanalyzed functional magnetic resonance imaging (fMRI) data from a previously published study with spider-phobic patients and healthy controls. The patients received glucocorticoids or a placebo before the exposure to spider images. There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls. Decoding in the ACC and the right insula showed strong evidence for correlation with experienced fear. Patients with cortisol reported a reduction of fear by 10-13%; however, there was only weak evidence for changes in neural decoding compared to placebo which was found in the precuneus, the opercular cortex, and the left cerebellum.",2020,There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls.,['spider-phobic patients and healthy controls'],"['placebo', 'glucocorticoids', 'Glucocorticoids', 'glucocorticoids or a placebo', 'functional magnetic resonance imaging (fMRI']","['neural decoding', 'reduction of fear']","[{'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0236284,There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schwab', 'Affiliation': 'Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, Nuffield Department of Population Health, University of Oxford, United Kingdom; Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland. Electronic address: simon.schwab@uzh.ch.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Federspiel', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Morishima', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland; Japan Science and Technology Agency, PRESTO, Saitama, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Nakataki', 'Affiliation': 'Department of Psychiatry, University of Tokushima, Tokushima, Japan.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Strik', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wiest', 'Affiliation': 'Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Dept. of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany; Freiburg Brain Imaging Center, University Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Quervain', 'Affiliation': 'Division of Cognitive Neuroscience, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Leila M', 'Initials': 'LM', 'LastName': 'Soravia', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111066']
358,31390907,Polyunsaturated Fatty Acid Impact on Clinical Outcomes in Acute Coronary Syndrome Patients With Dyslipidemia: Subanalysis of HIJ-PROPER.,"Background This study aimed to examine the impact of baseline eicosapentaenoic acid (EPA) to arachidonic acid (AA) ratio on clinical outcomes of patients with acute coronary syndrome. Methods and Results In the HIJ-PROPER (Heart Institute of Japan Proper Level of Lipid Lowering With Pitavastatin and Ezetimibe in Acute Coronary Syndrome) study, 1734 patients with acute coronary syndrome and dyslipidemia were randomly assigned to pitavastatin+ezetimibe therapy or pitavastatin monotherapy. We divided the patients into 2 groups based on EPA/AA ratio on admission (cutoff 0.34 μg/mL as median of baseline EPA/AA ratio) and examined their clinical outcomes. The primary end point comprised all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina pectoris, or ischemia-driven revascularization. Percentage reduction of low-density lipoprotein cholesterol and triglyceride from baseline to follow-up was similar regardless of baseline EPA/AA ratio. Despite the mean low-density lipoprotein cholesterol level during follow-up being similar between the low- and high-EPA/AA groups, the mean triglyceride levels during follow-up were significantly higher in the low- than in the high-EPA/AA group. After 3 years of follow-up, the cumulative incidence of the primary end point in patients with low EPA/AA was 27.2% in the pitavastatin+ezetimibe group compared with 36.6% in the pitavastatin-monotherapy group (hazard ratio 0.69; 95% CI, 0.52-0.93; P=0.015). However, there was no effect of pitavastatin+ezetimibe therapy on the primary end point in patients with high EPA/AA (hazard ratio 0.92; 95% CI, 0.70-1.20; P=0.52). Conclusions Among acute coronary syndrome patients who have dyslipidemia and low EPA/AA ratio, adding ezetimibe to statin decreases the risk of cardiovascular events compared with statin monotherapy. Clinical Trial Registration URL: http://www.umin.ac.jp/ctr. Unique identifier: UMIN000002742.",2019,Percentage reduction of low-density lipoprotein cholesterol and triglyceride from baseline to follow-up was similar regardless of baseline EPA/AA ratio.,"['Acute Coronary Syndrome', 'Acute Coronary Syndrome Patients', 'patients with acute coronary syndrome', '1734 patients with acute coronary syndrome and dyslipidemia', 'acute coronary syndrome patients who have dyslipidemia and low EPA/AA ratio']","['Polyunsaturated Fatty Acid Impact', 'baseline eicosapentaenoic acid (EPA) to arachidonic acid (AA) ratio', 'pitavastatin+ezetimibe', 'Pitavastatin and Ezetimibe', 'pitavastatin-monotherapy', 'pitavastatin+ezetimibe therapy or pitavastatin monotherapy']","['all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina pectoris, or ischemia-driven revascularization', 'cumulative incidence', 'mean triglyceride levels', 'mean low-density lipoprotein cholesterol level', 'low-density lipoprotein cholesterol and triglyceride']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",1734.0,0.16066,Percentage reduction of low-density lipoprotein cholesterol and triglyceride from baseline to follow-up was similar regardless of baseline EPA/AA ratio.,"[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology The Heart Institute of Japan Tokyo Women's Medical University Tokyo Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology The Heart Institute of Japan Tokyo Women's Medical University Tokyo Japan.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology The Heart Institute of Japan Tokyo Women's Medical University Tokyo Japan.""}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Koyanagi', 'Affiliation': ""Department of Cardiology The Heart Institute of Japan Tokyo Women's Medical University Tokyo Japan.""}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Sekiguchi', 'Affiliation': ""Department of Cardiology The Heart Institute of Japan Tokyo Women's Medical University Tokyo Japan.""}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Mori', 'Affiliation': 'National Hospital Organization Yokohama Medical Center Kanagawa Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Haruta', 'Affiliation': ""Tokyo Women's Medical University Yachiyo Medical Center Chiba Japan.""}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Ishii', 'Affiliation': 'Ogikubo Hospital Tokyo Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Murasaki', 'Affiliation': 'Tama Hokubu Medical Center Tokyo Japan.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Kosei Hospital Tokyo Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Sagamino Hospital Kanagawa Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology The Heart Institute of Japan Tokyo Women's Medical University Tokyo Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology The Heart Institute of Japan Tokyo Women's Medical University Tokyo Japan.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.012953']
359,32304829,Study Protocol: A randomized controlled trial of suicide risk reduction in the year following jail release (the SPIRIT Trial).,"PURPOSE
This article describes the protocol for a randomized effectiveness and cost-effectiveness trial of Stanley and Brown's Safety Planning Intervention (SPI) during pretrial jail detention to reduce post-release suicide events (suicide attempts, suicide behaviors, and suicide-related hospitalizations).
BACKGROUND
With 10 million admissions per year and short stays (often days), U.S. jails touch many individuals at risk for suicide, providing an important opportunity for suicide prevention that is currently being missed. This study (N = 800) is the first randomized evaluation of an intervention to reduce suicide risk in the vulnerable year after jail release. Given that roughly 10% of all suicides in the U.S. with known circumstances occur in the context of a criminal legal stressor, reducing suicide risk in the year after arrest and jail detention could have a noticeable impact on national suicide rates.
DESIGN
Pretrial jail detainees at risk for suicide were randomized to SPI during jail detention plus post-release phone follow-up or to enhanced Standard Care. Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness. Methods accommodate short jail stays and maximize trial safety and follow-up in a large sample with severe suicide risk, access to lethal means including substances and firearms, high rates of psychiatric illness, and unstable circumstances.
CONCLUSION
Adequate funding was important to create the infrastructure needed to run this large trial cleanly. We encourage funders to provide adequate resources to ensure clean, well-run trials.",2020,"Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness.","['Pretrial jail detainees at risk for suicide', 'With 10 million admissions per year and short stays (often days']","[""Stanley and Brown's Safety Planning Intervention (SPI"", 'SPI during jail detention plus post-release phone follow-up or to enhanced Standard Care']","['suicide risk', 'suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.211819,"Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness.","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Johnson', 'Affiliation': 'Michigan State University College of Human Medicine, 200 East 1(st) St Room 366, Flint, MI 48503, United States of America. Electronic address: JJohns@msu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Brown University Warren Alpert Medical School, 700 Butler Drive, Providence, RI 02906, United States of America. Electronic address: Richard_Jones@brown.edu.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation, 11720 Beltsville Drive, Suite 909, Calverton, MD 20705, United States of America. Electronic address: Miller@pire.org.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Miller', 'Affiliation': 'Brown University Warren Alpert Medical School, 345 Blackstone Blvd, Providence, RI 02906, United States of America. Electronic address: Ivan_Miller_iii@brown.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Columbia University, 1051 Riverside Drive, Unit 42, New York, NY 10032, United States of America. Electronic address: Bhs2@columbia.edu.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 3535 Market Street, Room 2032, Philadelphia, PA 19104, United States of America. Electronic address: gregbrow@mail.med.upenn.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Arias', 'Affiliation': 'Brown University Warren Alpert Medical School and Butler Hospital, 345 Blackstone Blvd, Providence, RI 02906, United States of America.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Cerbo', 'Affiliation': 'Rhode Island Department of Corrections, 1375 Pontiac Avenue, Cranston, RI 029020, United States of America. Electronic address: Louis.Cerbo@bhddh.ri.gov.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Rexroth', 'Affiliation': 'Genesee County Jail and Corizon Health, 1002 South Saginaw Street, Flint, MI 48502, United States of America. Electronic address: Julie.Rexroth@corizonhealth.com.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Fitting', 'Affiliation': 'The Providence Center, 528 N. Main Street, Providence, RI, 02904, United States of America. Electronic address: hfitting@provctr.org.'}, {'ForeName': 'Danis', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Genesee Health System, 420 West 5(th) Avenue, Flint, MI 48503, United States of America. Electronic address: drussell@ghs.org.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Kubiak', 'Affiliation': 'Wayne State University School of Social Work, 5447 Woodward Avenue, Detroit, MI 48202, United States of America. Electronic address: spk@wayne.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Boston University, 715 Albany Street, Talbot Building T2W, Boston, MA 02118, United States of America. Electronic address: mdstein@bu.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Matkovic', 'Affiliation': 'Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903, United States of America. Electronic address: Christopher_Matkovic@brown.edu.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Brown University Warren Alpert Medical School, 700 Butler Drive, Providence, RI 02906, United States of America. Electronic address: Shirley_Yen_PhD@brown.edu.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Gaudiano', 'Affiliation': 'Brown University Warren Alpert Medical School and Butler Hospital, 345 Blackstone Blvd, Providence, RI 02906, United States of America. Electronic address: Brandon_Gaudiano@brown.edu.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Weinstock', 'Affiliation': 'Brown University Warren Alpert Medical School, 700 Butler Drive, Providence, RI 02906, United States of America. Electronic address: Lauren_Weinstock@brown.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106003']
360,31825647,Lung Screen Uptake Trial (LSUT): Randomized Controlled Clinical Trial Testing Targeted Invitation Materials.,"Rationale: Low uptake of low-dose computed tomography (LDCT) lung cancer screening, particularly by current smokers of a low socioeconomic position, compromises effectiveness and equity. Objectives: To compare the effect of a targeted, low-burden, and stepped invitation strategy versus control on uptake of hospital-based Lung Health Check appointments offering LDCT screening. Methods: In a two-arm, blinded, between-subjects, randomized controlled trial, 2,012 participants were selected from 16 primary care practices using these criteria: 1 ) aged 60 to 75 years, 2 ) recorded as a current smoker within the last 7 years, and 3 ) no prespecified exclusion criteria contraindicating LDCT screening. Both groups received a stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments. The key manipulation was the accompanying leaflet. The intervention group's leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport's annual vehicle test (""M.O.T. For Your Lungs""). Measurements and Main Results: Uptake was 52.6%, with no difference between intervention (52.3%) and control (52.9%) groups in unadjusted (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.82-1.16) or adjusted (OR, 0.98; 95% CI, 0.82-1.17) analyses. Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers. Socioeconomic deprivation was significantly associated with lower uptake for the control group only ( P < 0.01). Conclusions: The intervention did not improve uptake. Regardless of trial arm, uptake was considerably higher than previous clinical and real-world studies, particularly given that the samples were predominantly lower socioeconomic position smokers. Strategies common to both groups, including a Lung Health Check approach, could represent a minimum standard.Clinical trial registered with www.clinicaltrials.gov (NCT02558101) and registered prospectively with the International Standard Registered Clinical/Social Study (N21774741).",2020,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","['Lung Screen Uptake Trial (LSUT', '2,012 participants were selected from 16 primary care practices using these criteria: 1 ) aged 60 to 75 years, 2 ) recorded as a current smoker within the last 7 years, and 3 ']","['low-dose computed tomography (LDCT) lung cancer screening', 'stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments', 'intervention group\'s leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport\'s annual vehicle test (""M.O.T. For Your Lungs']","['Socioeconomic deprivation', 'uptake']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]",2012.0,0.164682,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Ruparel', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dickson', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Beeken', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'McEwen', 'Affiliation': 'National Centre for Smoking Cessation and Training, Dorchester, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Angshu', 'Initials': 'A', 'LastName': 'Bhowmik', 'Affiliation': 'Department of Thoracic Medicine, Homerton University Hospital, London, United Kingdom.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Department of Thoracic Medicine, University College London Hospital, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sennett', 'Affiliation': 'Killick Street Health Centre, London, United Kingdom.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom; and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wardle', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-0946OC']
361,31507001,Recurrent atrial fibrillation/flutter detection after ablation or cardioversion using the AliveCor KardiaMobile device: iHEART results.,"OBJECTIVE
This study evaluated the impact of daily ECG (electrocardiogram) self-recordings on time to documented recurrent atrial fibrillation (AF) or atrial flutter (AFL) and time to treatment of recurrent arrhythmia in patients undergoing catheter radiofrequency ablation (RFA) or direct current cardioversion (DCCV) for AF/AFL.
BACKGROUND
AF recurrence rates after RFA and DCCV are 20% to 45% and 60% to 80%, respectively. Randomized trials comparing mobile ECG devices to standard of care have not been performed in an AF/AFL population after treatment.
METHODS
Of 262 patients consented, 238 were randomized to either standard of care (123) or to receive the iHEART intervention (115). Patients in the intervention group were provided with and trained to use an AliveCor KardiaMobile ECG monitor, and were instructed to take and transmit daily ECG recordings. Data were collected from transmitted ECG recordings and patients' electronic health records.
RESULTS
In a multivariate Cox model, the likelihood of recurrence detection was greater in the intervention group (hazard ratio = 1.56, 95% confidence interval [CI]: 1.06-2.30, P = .024). Hazard ratios did not differ significantly for RFA and DCCV procedures. Recurrence during the first month after ablation strongly predicted later recurrence (hazard ratio = 4.53, 95% CI: 2.05-10.00, P = .0006). Time from detection to treatment was shorter for the control group (hazard ratio = 0.33, 95% CI: 0.57-2.92, P < .0001).
CONCLUSIONS
The use of mobile ECG self-recording devices allows for earlier detection of AF/AFL recurrence and may empower patients to engage in shared health decision-making.",2019,"Time from detection to treatment was shorter for the control group (hazard ratio = 0.33, 95% CI: 0.57-2.92, P < .0001).
","['patients undergoing', 'Of 262 patients consented, 238 were randomized to either standard of care (123) or to receive the']","['mobile ECG devices', 'AliveCor KardiaMobile ECG monitor, and were instructed to take and transmit daily ECG recordings', 'daily ECG (electrocardiogram) self-recordings', 'iHEART intervention', 'catheter radiofrequency ablation (RFA) or direct current cardioversion (DCCV', 'mobile ECG self-recording devices']","['likelihood of recurrence detection', 'Hazard ratios', 'recurrent atrial fibrillation (AF) or atrial flutter (AFL', 'Recurrence', 'later recurrence', 'Recurrent atrial fibrillation/flutter detection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0303719', 'cui_str': 'Americium-238 (substance)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0542380', 'cui_str': 'Direct current cardioversion (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0741282', 'cui_str': 'Recurrent atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}]",238.0,0.117432,"Time from detection to treatment was shorter for the control group (hazard ratio = 0.33, 95% CI: 0.57-2.92, P < .0001).
","[{'ForeName': 'Isaac L', 'Initials': 'IL', 'LastName': 'Goldenthal', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Sciacca', 'Affiliation': 'Columbia University School of Nursing, New York, New York.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Riga', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bakken', 'Affiliation': 'Columbia University School of Nursing, New York, New York.'}, {'ForeName': 'Maurita', 'Initials': 'M', 'LastName': 'Baumeister', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Biviano', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Dizon', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine - Cardiology, White Plains Hospital, New York, New York.'}, {'ForeName': 'Ketty C', 'Initials': 'KC', 'LastName': 'Wang', 'Affiliation': 'Columbia University School of Nursing, New York, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Whang', 'Affiliation': 'Department of Medicine - Cardiology, Icahn School of Medicine, New York, New York.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Hickey', 'Affiliation': 'Columbia University School of Nursing, New York, New York.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Garan', 'Affiliation': 'Department of Medicine - Cardiology, Columbia University Irving Medical Center, New York, New York.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14160']
362,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES
The objective of this study is to evaluate the progression and new onset of macular retinoschisis (MRS) in the patients treated with intravitreal Conbercept injections for myopic choroidal neovascularization (mCNV).
METHODS
Post-hoc analysis of 160 mCNV patients included in SHINY study was performed to evaluate the impact of Conbercept injection on MRS in patients with mCNV undergoing intravitreal Conbercept injections. The patients were 3:1 randomized to the study group (three loading dose and thereafter pro re nata [PRN]) and the control group (3 months' sham injection, then one Conbercept injection at month 4 and thereafter PRN). MRS was assessed with optical coherence tomography by masked graders.
RESULTS
At baseline, 28 of 122 eyes in study group and 10 of 38 eyes in control group had MRS. At month 3, two patients showed MRS progression and one patient had new onset MRS in study group. No MRS progression nor new onset MRS was found in the control group. At final visit, the cumulative incidence of MRS was 1.3% (2/160). Both Spearman's correlation and multiple logistic regression demonstrated no association between the progression and new onset of MRS and intravitreal injection frequency (correlation coefficient = 0.017, P = 0.851 and odds ratio = 0.996, P = 0.982). In addition, baseline vitreoretinal adhesion was the most likely potential risk factor resulting in MRS progression (odds ratio = 4.566, P = 0.027). Furthermore, MRS progression was more likely to take place in outer retinal layers.
CONCLUSIONS
The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x']
363,32298143,Randomized Controlled Trial of a Novel Peer Concussion-Education Program for Collegiate Athletes.,"CONTEXT
The National Collegiate Athletic Association and US Department of Defense have called for educational programs to change the culture of concussion reporting, increase reporting behavior, and enhance the safety of players and service members.
OBJECTIVE
To evaluate the effects of a novel peer concussion-education program (PCEP) in changing knowledge, attitudes, and norms about concussion reporting among collegiate student-athletes and assess program implementation.
DESIGN
Randomized controlled trial and qualitative analysis of interviews.
SETTING
National Collegiate Athletic Association athletic teams from randomly selected colleges or universities.
PATIENTS OR OTHER PARTICIPANTS
A total of 1614 male and female student-athletes from 60 teams at 10 colleges and universities and 8 athletic trainers.
INTERVENTION(S)
The PCEP intervention trains 2 peer concussion educators to provide 2 education modules to their teammates. Knowledge, attitudes (oneself and teammates), and concussion occurrence or reporting were assessed at baseline, postintervention, and 1 month later. Eight athletic trainers were interviewed about program implementation.
RESULTS
Compared with the control group, the intervention group showed greater increases occurred postintervention and at 1 month in concussion knowledge ( F 1,2648 = 51.3, P < .0001), intention to report (oneself, F 2,2633 = 82.3, P < .0001; teammates, F 2,2624 = 53.9, P < .0001), return-to-play protocol knowledge, ( F 2,2632 = 28.4, P < .0001), direct subjective norms (oneself, F 2,2625 = 51.7, P < .0001; teammates, F 2,2644 = 40.6, P < .0001), direct perceived behavioral control (oneself, F 2,2628 = 53.7, P < .0001; teammates, F 2,2615 = 68.2, P < .0001), and indirect attitudes (oneself, F 2,2626 = 47.1, P < .001; teammates, F 2,2623 = 40.9, P < .0001). Peer concussion-education program participants discussed concussion more often with a teammate ( F 1,1396 = 13.96, P < .0001) or athletic staff ( F 1,1396 = 6.62, P < .001). Qualitative program analysis revealed both positive aspects of the PCEP and areas for improvement.
CONCLUSIONS
The PCEP showed promise in increasing concussion knowledge, intention to report concussion, reporting a teammate's concussion, and facilitating attitudinal changes that support reporting among student-athletes.",2020,"Compared with the control group, the intervention group showed greater increases occurred postintervention and at 1 month in concussion knowledge ( F 1,2648 = 51.3, P < .0001), intention to report (oneself, F 2,2633 = 82.3, P < .0001; teammates, F 2,2624 = 53.9, P < .0001), return-to-play protocol knowledge, ( F 2,2632 = 28.4, P < .0001), direct subjective norms (oneself, F 2,2625 = 51.7, P < .0001; teammates, F 2,2644 = 40.6, P < .0001), direct perceived behavioral control (oneself, F 2,2628 = 53.7, P < .0001; teammates, F 2,2615 = 68.2, P < .0001) and indirect attitudes (oneself, F 2,2626 ","['1614 male and female student-athletes from 60 teams at 10 colleges and universities and 8 athletic trainers', 'Eight athletic trainers', 'National Collegiate Athletic Association athletic teams from randomly selected colleges or universities', 'Collegiate Athletes']","['novel peer concussion-education program (PCEP', 'Novel Peer Concussion-Education Program', 'PCEP']","['indirect attitudes (oneself, F 2,2626', 'return-to-play protocol knowledge', 'concussion knowledge', 'Knowledge, attitudes (oneself and teammates), and concussion occurrence or reporting', 'athletic staff', 'direct subjective norms']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]",1614.0,0.0448974,"Compared with the control group, the intervention group showed greater increases occurred postintervention and at 1 month in concussion knowledge ( F 1,2648 = 51.3, P < .0001), intention to report (oneself, F 2,2633 = 82.3, P < .0001; teammates, F 2,2624 = 53.9, P < .0001), return-to-play protocol knowledge, ( F 2,2632 = 28.4, P < .0001), direct subjective norms (oneself, F 2,2625 = 51.7, P < .0001; teammates, F 2,2644 = 40.6, P < .0001), direct perceived behavioral control (oneself, F 2,2628 = 53.7, P < .0001; teammates, F 2,2615 = 68.2, P < .0001) and indirect attitudes (oneself, F 2,2626 ","[{'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Kneavel', 'Affiliation': 'School of Nursing and Health Sciences, La Salle University, Philadelphia, PA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ernst', 'Affiliation': 'Center for Concussion Education and Research, Chestnut Hill College, Philadelphia, PA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'McCarthy', 'Affiliation': 'Center for Concussion Education and Research, Chestnut Hill College, Philadelphia, PA.'}]",Journal of athletic training,['10.4085/1062-6050-0182.19']
364,31701593,"Activated clotting time on the day of atrial fibrillation ablation for minimally interrupted and uninterrupted direct oral anticoagulation therapy: Sequential changes, differences among direct oral anticoagulants, and ablation safety outcomes.","BACKGROUND
Activated clotting time (ACT)-guided heparinization is used during atrial fibrillation (AF) ablation. Differences in sensitivity to ACT assays have been identified among different direct oral anticoagulants (DOACs).
OBJECTIVE
We aimed to examine ACT just before ablation (pre-ACT) for different ablation start times (9:00, 11:00, 13:00, or 15:00) and ablation safety outcomes in minimally interrupted (min-Int) and uninterrupted (Unint) DOAC regimens and examine differences in pre-ACT values among four DOACs.
METHODS
Consecutive patients were randomized into the min-Int (n = 307) or Unint (n = 277) groups. DOACs examined were apixaban, dabigatran, edoxaban, and rivaroxaban.
RESULTS
No sequential changes in pre-ACT values were observed for each DOAC used and for all four DOACs combined in the min-Int and Unint groups. There was no meaningful difference in pre-ACT at each ablation start time between the groups. Clinically significant differences in overall pre-ACT were not obtained between the groups (138 ± 24 vs 142 ± 23 seconds). The pre-ACT (baseline) value for dabigatran was on average 29 seconds higher than that for the other three DOACs. The min-Int and Unint groups showed similar thromboembolic (0% vs 0%) and bleeding event rates (major, 1% vs 0%; all, 3.5% vs 2.5%).
CONCLUSION
The pre-ACT did not show a sequential change in the min-Int and Unint groups. No notable differences in the time-dependent change in pre-ACT between the groups were observed. Variations in baseline ACT suggest the need for moderate adjustment of ACT for adequate modification of heparin dose for the other three DOACs. Both regimens provided similar acceptable AF ablation safety outcomes.",2019,Clinically significant differences in overall pre-ACT were not obtained between the groups (138±24 vs 142±23 s).,['Consecutive patients were randomized into the min-Int (n=307) or Unint (n=277) groups'],"['apixaban, dabigatran, edoxaban']","['bleeding event rates', 'similar thromboembolic', 'ablation safety outcomes', 'pre-ACT values', 'overall pre-ACT', 'time-dependent change in pre-ACT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0288874,Clinically significant differences in overall pre-ACT were not obtained between the groups (138±24 vs 142±23 s).,"[{'ForeName': 'Hirosuke', 'Initials': 'H', 'LastName': 'Yamaji', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Hina', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Shunich', 'Initials': 'S', 'LastName': 'Higashiya', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawamura', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Shigeshi', 'Initials': 'S', 'LastName': 'Kamikawa', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hirohata', 'Affiliation': 'Department of Medical Technology, Graduate School of Health Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Kusachi', 'Affiliation': 'Department of Medical Technology, Graduate School of Health Sciences, Okayama University, Okayama, Japan.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14260']
365,31916660,"Understanding the impact of complicated grief on combat related posttraumatic stress disorder, guilt, suicide, and functional impairment in a clinical trial of post-9/11 service members and veterans.","BACKGROUND
Complicated grief (CG) is a bereavement-specific syndrome distinct from but commonly comorbid with posttraumatic stress disorder (PTSD). While bereavement is common among military personnel (Simon et al., 2018), there is little research on the impact of CG comorbidity on PTSD treatment outcomes.
METHODS
To evaluate the impact of comorbid CG on PTSD treatment outcomes we analyzed data from a randomized trial comparing prolonged exposure, sertraline, and their combination in veterans with a primary diagnosis of combat-related PTSD (n = 194). Assessment of PTSD, trauma-related guilt, functional impairment, and suicidal ideation and behavior occurred at baseline and weeks 6, 12, and 24 during the 24-week trial.
RESULTS
CG was associated with lower PTSD treatment response (odds ratio (OR) = 0.29, 95% confidence interval (CI) [0.12, 0.69], p = 0.005) and remission (OR = 0.28, 95% CI [0.11, 0.71], p = 0.007). Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint. In addition, those with CG were more likely to experience suicidal ideation during the study (CG: 35%, 14/40 vs. no CG 15%, 20/130; OR = 3.01, 95% CI [1.29, 7.02], p = 0.011).
CONCLUSIONS
Comorbid CG is associated with elevated PTSD severity and independently associated with poorer endpoint treatment outcomes in veterans with combat-related PTSD, suggesting that screening and additional intervention for CG may be needed.",2020,Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint.,"['post-9/11 service members and veterans', 'veterans with a primary diagnosis of combat-related PTSD (n\u2009=\u2009194']",['sertraline'],"['remission', 'trauma-related guilt', 'severity of PTSD', 'Assessment of PTSD, trauma-related guilt, functional impairment, and suicidal ideation and behavior', 'PTSD treatment response', 'experience suicidal ideation']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0594661,Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint.,"[{'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Lubin', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Robinaugh', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Malgaroli', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'National Center for PTSD, White River Junction, Vermont.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'Mental Health Service Line, Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Goetter', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Samantha N', 'Initials': 'SN', 'LastName': 'Hellberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Charney', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Amanda W', 'Initials': 'AW', 'LastName': 'Baker', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, Decatur, Georgia.'}]",Depression and anxiety,['10.1002/da.22911']
366,31309627,In situ antioxidant activity of a dermo-cosmetic product: A randomized controlled clinical study.,"Ultraviolet light enhances the generation of reactive oxygen species that are responsible for skin photoageing. The aim of this randomized, vehicle- and active-controlled double-blind, intra-individual monocentric study was to evaluate in situ the antioxidant activity of a dermo-cosmetic product in photoaged skin. Twenty healthy volunteers had defined skin areas randomized to receive a topical product containing 3 antioxidants (pre-tocopheryl ® , retinaldehyde and glycylglycine ole-amide), its vehicle and a positive antioxidant control cream. The products were applied daily for 30-day period. The skin areas were exposed to a controlled dose of UVA rays, and the skin oxidative status was evaluated 4 and 24 hours post-UVA exposure at D0 (basal value) and after 15 and 30 days of product application. Skin layers were collected by stripping, and antioxidant capacity was measured using the ferric reducing ability of a plasma assay. Lipid peroxidation (LPO) was assessed using the malonyldialdehyde test. The tested product significantly improved the skin antioxidant capacity after 15 and 30 days and significantly decreased the basal level of the skin LPO. The skin LPO level significantly decreased 4 and 24 hours after UVA exposure at 15 and 30 days. These findings were comparable to positive control treated sites and were significantly different from the vehicle and untreated sites. This minimally invasive methodology enabled a quantitative evaluation of potent antioxidant activity in situ in the stratum corneum reflecting real-life skin conditions and confirming the benefits of the topical application of a product containing 3 antioxidants in the prevention of UVA-induced oxidative damage.",2019,The tested product significantly improved the skin antioxidant capacity after 15 and 30 days and significantly decreased the basal level of the skin LPO.,"['Twenty healthy volunteers had defined skin areas', 'photoaged skin']","['topical product containing 3 antioxidants (pre-tocopheryl ® , retinaldehyde and glycylglycine ole-amide), its vehicle and a positive antioxidant control cream']","['Lipid peroxidation (LPO', 'skin oxidative status', 'Skin layers', 'skin LPO level', 'basal level of the skin LPO', 'skin antioxidant capacity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C3205659', 'cui_str': 'Topical Product'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1669538', 'cui_str': 'pretocopheryl'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0017984', 'cui_str': 'Glycylglycine'}, {'cui': 'C0002482', 'cui_str': 'Amides'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1282402', 'cui_str': 'Skin layer'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",20.0,0.0699519,The tested product significantly improved the skin antioxidant capacity after 15 and 30 days and significantly decreased the basal level of the skin LPO.,"[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Ribet', 'Affiliation': 'Clinical Skin Research Center, Pierre Fabre Dermo-Cosmetics, Toulouse, France.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Nobile', 'Affiliation': 'Complife Italia, San Martino Siccomario (PV), Italy.'}, {'ForeName': 'Ana Beatris', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Clinical Skin Research Center, Pierre Fabre Dermo-Cosmetics, Toulouse, France.'}]",Experimental dermatology,['10.1111/exd.14005']
367,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE
To determine the utility of the dexamethasone implant (IVD) as an alternative to systemic steroids as prophylaxis against cystoid macular edema (CMO) in patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery.
METHODS
This was a randomized, parallel design, and clinical trial. Patients with IU/PU and cataract scheduled for cataract surgery were randomly assigned to receive the IVD concurrently with cataract surgery (Group 1: 20 patients) or systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care. Patients with glaucoma/contraindications to steroids were excluded. All patients were followed up for 6 months.
OUTCOME MEASURE
Primary-incidence of postoperative CMO. Secondary-the change in BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications. Appropriate statistical analysis was done.
RESULTS
The median age was 47.3 ± 4.23 years (group 1) and 49.12 ± 5.32 years (Group 2). One patient (Group 1) and two (Group 2) developed CMO. The BCVA improved significantly in both groups (p = 0.013). The CST change was insignificant. Four patients (Group 1) required intraocular pressure (IOP) lowering medications. Three patients (Group 2) required early steroid taper.
CONCLUSIONS
IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8']
368,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES
This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
SUBJECTS/METHODS
Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
RESULTS
Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
CONCLUSIONS
Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z']
369,31074178,Appetite and food intake results from phase I studies of anamorelin.,"BACKGROUND
Loss of appetite and body weight are potentially devastating, highly prevalent cancer complications. The ghrelin receptor is a mediator of appetite and metabolism, and anamorelin is a novel, orally administered ghrelin receptor agonist. Effects on appetite and food intake may influence body-weight gain but can be difficult to measure in multi-site studies. Here, we summarize two single-centre trials.
METHODS
Both trials were phase I, randomized, double-blind, placebo-controlled, partly/wholly crossover studies of healthy young adults. Study 102 tested single anamorelin doses of 1-20 mg. Assessments included post-dose self-ratings on 100 mm visual analogue scales for hunger, anticipated eating pleasure, and anticipated quantity of food consumption. Study 101 tested single 10, 25, and 50 mg doses. Assessments included the same scales plus caloric intake beginning 4 h post-dose.
RESULTS
Study 102 treated 16 male subjects (mean age, 26.3 years). Mean hunger scores generally increased after all treatments, with significant differences from placebo (P < 0.05) in the 5 mg anamorelin group at 0.5 and 1 h post-dose (+8.2 and +13.2 mm). Results for other scales were similar. Study 101 treated nine male subjects (mean age, 26.3 years). Pooled findings for anamorelin 25 and 50 mg vs. placebo showed significant mean increases in hunger scores at all but 1 pre-prandial time point, including the first assessment, 0.5 h post-dose (+10.9 vs. +0.7 mm, P = 0.0077), and the last assessment, 4 h post-dose (+32.7 vs. +7.0 mm, P = 0.0170), with a significant mean 18.4% increase vs. placebo in caloric intake (P = 0.0148).
CONCLUSIONS
In single-centre studies of healthy adults, single anamorelin doses of 1-20 mg elicited modest increases in hunger, and single doses of 25 and 50 mg achieved significant increases in hunger and caloric intake. The findings are consistent with dose-related weight gain reported in a prior phase I study as well as multi-centre findings in cachectic cancer patients and expand the evidence supporting anamorelin as a potential intervention.",2019,"Mean hunger scores generally increased after all treatments, with significant differences from placebo (P < 0.05) in the 5 mg anamorelin group at 0.5 and 1 h post-dose (+8.2 and +13.2 mm).","['cachectic cancer patients', 'Study 102 treated 16 male subjects (mean age, 26.3 years', 'Study 101 treated nine male subjects (mean age, 26.3 years', 'healthy adults', 'healthy young adults']",['placebo'],"['post-dose self-ratings on 100 mm visual analogue scales for hunger, anticipated eating pleasure, and anticipated quantity of food consumption', 'hunger and caloric intake', 'caloric intake', 'Mean hunger scores', 'hunger scores', 'weight gain']","[{'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517668', 'cui_str': 'Twenty-six point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439568', 'cui_str': 'Post-dose (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",9.0,0.375845,"Mean hunger scores generally increased after all treatments, with significant differences from placebo (P < 0.05) in the 5 mg anamorelin group at 0.5 and 1 h post-dose (+8.2 and +13.2 mm).","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Blum', 'Affiliation': 'Buffalo Clinical Research Center, LLC, Buffalo, NY, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Mair', 'Affiliation': 'Formerly, Inveresk Research, Edinburgh, UK.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Duus', 'Affiliation': 'Formerly, Helsinn Therapeutics (US), Incorporated, Iselin, NJ, USA.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12439']
370,32298418,A randomized trial of contact force in atrial flutter ablation.,"AIMS
Contact force (CF) sensing has emerged as a tool to guide and improve outcomes for catheter ablation (CA) for cardiac arrhythmias. The clinical benefit on patient outcomes remains unknown. To study whether CF-guided CA for typical atrial flutter (AFL) is superior to CA not guided by CF.
METHODS AND RESULTS
In a double-blinded controlled superiority trial, we randomized patients 1:1 to receive CA for typical AFL guided by CF (intervention group) or blinded to CF (control group). In the intervention group, a specific value of the lesion size index (LSI), estimating ablation lesions size was targeted for each ablation lesion. Patients underwent electrophysiological study (EPS) after 3 months to assess occurrence of the primary endpoint of re-conduction across the cavo-tricuspid isthmus (CTI). We included 156 patients with typical AFL, median age was 68 [interquartile range (IQR) 61-74] years and 120 (77%) patients were male. At index procedure median LSI was higher in the intervention group [6.4 (IQR 5.1-7) vs. 5.6 (IQR 4.5-6.9), P < 0.0001]. After 3 months, 126 patients (58 in intervention group) underwent EPS for primary endpoint assessment. Thirty (24%) patients had CTI re-conduction, distributed with 15 patients in each treatment group (P = 0.62). We observed no difference between treatment groups with regard to fluoroscopy, ablation, or procedure times, nor peri-procedural complications.
CONCLUSION
Contact force-guided ablation does not reduce re-conduction across the CTI after 3 months, nor does CF-guided ablation shorten fluoroscopy, ablation, or total procedure times.",2020,"We observed no difference between treatment groups with regard to fluoroscopy, ablation, or procedure times, nor peri-procedural complications.
","['156 patients with typical AFL, median age was 68 [interquartile range (IQR) 61-74] years and 120 (77%) patients were male', 'atrial flutter ablation']","['CF-guided CA', 'CA for typical AFL guided by CF (intervention group) or blinded to CF (control group', 'Contact force-guided ablation']","['re-conduction across the cavo-tricuspid isthmus (CTI', 'specific value of the lesion size index (LSI), estimating ablation lesions size', 'index procedure median LSI', 'fluoroscopy, ablation, or procedure times, nor peri-procedural complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3264370', 'cui_str': 'Typical atrial flutter'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0221799', 'cui_str': 'Intravascular guiding catheter'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C3264370', 'cui_str': 'Typical atrial flutter'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid'}, {'cui': 'C0229583', 'cui_str': 'Structure of isthmus of thyroid gland'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}]",156.0,0.102359,"We observed no difference between treatment groups with regard to fluoroscopy, ablation, or procedure times, nor peri-procedural complications.
","[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Giehm-Reese', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Mads Brix', 'Initials': 'MB', 'LastName': 'Kronborg', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lukac', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Steen Buus', 'Initials': 'SB', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Henrik Kjærulf', 'Initials': 'HK', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerdes', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Jan Møller', 'Initials': 'JM', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}, {'ForeName': 'Jens Cosedis', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa049']
371,32302791,"A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol.","This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762). This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk.",2020,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","['chronic pain', '300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study']","['Structural equation modeling (SEM', 'telehealth group sessions of CT, MM, or AS', 'chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS', 'cognitive, behavioral and mindfulness-based psychosocial treatments']","['Pain Interference scale', 'cognitive content, cognitive process, and/or activity level', 'PROMIS 5-item']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",300.0,0.103487,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia. Electronic address: m.day@uq.edu.au.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Friedly', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mendoza', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Battalio', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Borckardt', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106000']
372,31492766,A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities.,"BACKGROUND
The efficacy of epidermal growth factor (EGF) receptor (EGFR) inhibitors in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC), or colorectal cancer (CRC) has been demonstrated. However, dermatological reactions to these inhibitors can cause significant physical and psychosocial discomfort. The objective of the present study was to evaluate the efficacy of EGF ointment for EGFR inhibitor-related skin adverse events (ERSEs).
MATERIALS AND METHODS
This placebo-controlled, double-blind, multicenter, pilot phase III trial enrolled patients with NSCLC, PC, or CRC treated with EGFR inhibitors. Patients with grade ≥2 ERSEs were included. Patients were randomized to three treatment arms: arm 1, placebo; arm 2, 1 ppm of EGF ointment; and arm 3, 20 ppm of EGF ointment. Patients applied ointment to their skin lesions twice daily.
RESULTS
Efficacy evaluation was available for 80 patients (9 for PC, 28 for NSCLC, and 43 for CRC). Responses were 44.4% in arm 1, 61.5% in arm 2, and 77.8% in arm 3. There was a linear correlation between EGF concentrations and responses (p = .012). Quality of life (QoL) was assessed for 74 patients. Maximum changes in composite scores by Skindex-16 after treatment were significantly different among arms (mean ± SD: -5.2 ± 8.6 for arm 1, -11.7 ± 14.2 for arm 2, and - 18.6 ± 17.7 for arm 3; p = .008). EGF arms showed significant improvement in emotions (p = .005) and functioning (p = .044) scores over the placebo arm.
CONCLUSION
EGF ointment is effective for managing ERSEs. It can also improve patients' QoL compared with placebo. Clinical trial identification number. NCT02284139 IMPLICATIONS FOR PRACTICE: Patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer who are treated with epidermal growth factor (EGF) receptor (EGFR) inhibitors may experience dermatologic reactions to their treatment. This study investigated the benefit of an EGF ointment in the treatment of these adverse events and observed the ointment to be effective in managing EGFR inhibitor-related skin adverse events.",2020,"EGF arms showed significant improvement in emotions ( p = .005) and functioning ( p = .044) scores over the placebo arm.
","['80 patients (9 for PC, 28 for NSCLC, and 43 for CRC', 'Patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer who are treated with', 'enrolled patients with NSCLC, PC, or CRC treated with EGFR inhibitors', 'Patients with grade ≥2 ERSEs were included', '74 patients', 'patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC), or colorectal cancer (CRC']","['EGF ointment', 'EGF', 'placebo', 'Epidermal Growth Factor Ointment', 'epidermal growth factor (EGF) receptor (EGFR) inhibitors']","['Quality of life (QoL', 'EGF concentrations and responses', 'Maximum changes in composite scores', 'emotions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0034380'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",80.0,0.0868472,"EGF arms showed significant improvement in emotions ( p = .005) and functioning ( p = .044) scores over the placebo arm.
","[{'ForeName': 'Young Saing', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': 'Division of Hematology-Oncology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.'}, {'ForeName': 'Sung Yong', 'Initials': 'SY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Suee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Seok Jae', 'Initials': 'SJ', 'LastName': 'Huh', 'Affiliation': 'Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Ki-Hoon', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Choon Hee', 'Initials': 'CH', 'LastName': 'Son', 'Affiliation': 'Department of Pulmonology, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Mee Sook', 'Initials': 'MS', 'LastName': 'Roh', 'Affiliation': 'Department of Pathology, Dong-A University College of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Gyeong Won', 'Initials': 'GW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Tae', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Chan Kyu', 'Initials': 'CK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Joung Soon', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'In Gyu', 'Initials': 'IG', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Kyung', 'Initials': 'HK', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Lee Chun', 'Initials': 'LC', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Kosin University College of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.'}, {'ForeName': 'Seong-Geun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.'}, {'ForeName': 'Sang-Cheol', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Hospital Cheonan, Cheonan, Republic of Korea.'}, {'ForeName': 'Do-Hyoung', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea.'}, {'ForeName': 'Soon Il', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea.'}, {'ForeName': 'Jung Hun', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.'}]",The oncologist,['10.1634/theoncologist.2019-0221']
373,30756406,Working with parents to counteract bullying: A randomized controlled trial of an intervention to improve parent-school cooperation.,"This study examined the effectiveness of an intervention aimed at improving parent-school cooperation in counteracting bullying. Using a randomized controlled trial, data of teachers, parents of non-victimized children, and children themselves were collected at 13 intervention and 14 control schools (grades 3-6, N at post-assessment: teachers = 83, parents = 153, children = 2,510) at two time points (time lag about 6 months). Results showed positive effects of the intervention for some aspects of the primary outcomes: parents' and teachers' attitudes and efforts, whereas no effects were found of teachers' or parents' competences in counteracting bullying. No intervention effects were found for secondary outcomes: children's self-reported bullying, victimization, well-being, and self-esteem. The findings indicate that, due to the intervention, teachers and parents were more aligned and able to cooperate, even within the short time of the intervention: one school year. This is the first essential step to systematically addressing parents' role in tackling bullying; future research is needed to examine the long-term effects of parent and school interventions in enhancing the effectiveness of anti-bullying programs.",2020,"No intervention effects were found for secondary outcomes: children's self-reported bullying, victimization, well-being, and self-esteem.","['teachers, parents of non-victimized children, and children themselves were collected at 13 intervention and 14 control schools (grades 3-6, N at post-assessment: teachers\xa0=\xa083, parents\xa0', '153, children\xa0=\xa02,510) at two time points']",[],"[""secondary outcomes: children's self-reported bullying, victimization, well-being, and self-esteem""]","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",[],"[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",,0.03064,"No intervention effects were found for secondary outcomes: children's self-reported bullying, victimization, well-being, and self-esteem.","[{'ForeName': 'Coby', 'Initials': 'C', 'LastName': 'van Niejenhuis', 'Affiliation': 'Department of Sociology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Huitsing', 'Affiliation': 'Department of Sociology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Veenstra', 'Affiliation': 'Department of Sociology, University of Groningen, Groningen, The Netherlands.'}]",Scandinavian journal of psychology,['10.1111/sjop.12522']
374,32240909,Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial.,"BACKGROUND
Preoperative chemoradiotherapy (CRT) followed by total mesorectal excision is widely accepted as the standard of care for high-risk rectal cancer. Adjuvant chemotherapy is advised in several international guidelines, although the survival benefit remains unclear and compliance is poor. The current multidisciplinary approach has led to major improvements in local control, yet the occurrence of distant metastases has not decreased accordingly. The combination of short-course radiotherapy (SCRT) and chemotherapy in the waiting period before surgery might have several benefits, including higher compliance, downstaging and better effect of systemic therapy.
METHODS
This is an investigator-initiated, international multicentre randomized phase III trial. High-risk rectal cancer patients were randomized to SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy (25-28 × 2-1.8 Gy) with concomitant capecitabine followed by surgery and optional postoperative chemotherapy (8 cycles CAPOX or 12 cycles FOLFOX4) according to local institutions' policy. The primary endpoint is time to disease-related treatment failure. Here, we report the compliance, toxicity and postoperative complications in both study groups.
FINDINGS
Between June 2011 and June 2016, 920 patients were enrolled. Of these, 901 were evaluable (460 in the experimental arm and 441 in the standard arm). All patients in the experimental arm received 5 × 5 Gy radiotherapy, and 84% of all patients received at least 75% of the prescribed chemotherapy. In the standard arm, the compliance for CRT was 94% and 57% for postoperative chemotherapy. Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy. No statistically significant differences in surgical procedures or postoperative complications were observed.
INTERPRETATION
High compliance (84%) of preoperative systemic treatment could be achieved with the experimental approach. Although considerable toxicity was observed during preoperative therapy, this did not lead to differences in surgical procedures or postoperative complications. Longer follow-up time is needed to assess the primary endpoint and related outcomes.",2020,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","['High-risk rectal cancer patients', 'high-risk rectal cancer ', 'Between June 2011 and June 2016, 920 patients were enrolled', '901 were evaluable (460 in the experimental arm and 441 in the standard arm']","['short-course radiotherapy', '5\xa0×\xa05 Gy radiotherapy', 'preoperative chemotherapy and surgery', 'short-course radiotherapy (SCRT) and chemotherapy', 'Adjuvant chemotherapy', 'Preoperative chemoradiotherapy (CRT', 'SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy', 'concomitant capecitabine followed by surgery and optional postoperative chemotherapy']","['Toxicity ≥grade 3', 'time to disease-related treatment failure', 'Compliance and tolerability', 'compliance, toxicity and postoperative complications', 'toxicity', 'surgical procedures or postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",920.0,0.114836,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","[{'ForeName': 'Maxime J M', 'Initials': 'MJM', 'LastName': 'van der Valk', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands. Electronic address: mvandervalk@lumc.nl.'}, {'ForeName': 'Corrie A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Radiotherapy, Leiden University Medical Center, The Netherlands; Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Esmée A', 'Initials': 'EA', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Hilling', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Annet G H', 'Initials': 'AGH', 'LastName': 'Roodvoets', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Renu R', 'Initials': 'RR', 'LastName': 'Bahadoer', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Fokstuen', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert Jan', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': 'Department of Medical Oncology, Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO). Barcelona, Spain.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Edhemovic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology Ljubljana, Slovenia.'}, {'ForeName': 'Andrès M R', 'Initials': 'AMR', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Derk Jan A', 'Initials': 'DJA', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Per J', 'Initials': 'PJ', 'LastName': 'Nilsson', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Sweden.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Geke A P', 'Initials': 'GAP', 'LastName': 'Hospers', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands. Electronic address: g.a.p.hospers@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.03.011']
375,31042813,"The association of early linear growth and haemoglobin concentration with later cognitive, motor, and social-emotional development at preschool age in Ghana.","It is important to identify the periods during childhood when exposure to environmental risk factors results in long-term neurodevelopmental deficits. Stunting and anaemia may be sensitive indicators of exposure to such risks. In a prospective cohort enrolled before birth, we investigated the association of developmental scores at 4-6 years with (a) birth length and linear growth during three postnatal periods and (2) haemoglobin (Hb) concentration at three time points. Children were participants in a follow-up study of a randomized controlled trial of nutritional supplementation in Ghana. At 4-6 years, cognitive, motor, and social-emotional developments were assessed using standard tests adapted for this population. We estimated the associations of length-for-age z-score (LAZ) at birth and postnatal linear growth (n = 710) and Hb (n = 617) with developmental scores in regression models, using multistage least squares analysis to calculate uncorrelated residuals for postnatal growth. Cognitive development at 4-6 years was significantly associated with LAZ at birth (β = 0.12, 95% CI = 0.05, 0.19), ΔLAZ from 6 to 18 months (β = 0.16, 95% CI = 0.04, 0.28), and Hb at 18 months (β = 0.13, 95% CI = 0.06, 0.20), but not with ΔLAZ during 0-6 months, ΔLAZ from 18 months to 4-6 years, Hb at 6 months, or Hb at 4-6 years. No evidence of associations with motor or social-emotional development were found. These results suggest that in similar contexts, the earlier periods prior to birth and up to 18 months are more sensitive to risk factors for long-term cognitive development associated with LAZ and Hb compared with later childhood. This may inform the optimal timing of interventions targeting improved cognitive development.",2019,No evidence of associations with motor or social-emotional development were found.,['at preschool age in Ghana'],"['ΔLAZ', 'nutritional supplementation']","['Cognitive development', 'cognitive, motor, and social-emotional developments', 'early linear growth and haemoglobin concentration with later cognitive, motor, and social-emotional development', 'motor or social-emotional development']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}]",710.0,0.0414439,No evidence of associations with motor or social-emotional development were found.,"[{'ForeName': 'Maku E', 'Initials': 'ME', 'LastName': 'Ocansey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Sika M', 'Initials': 'SM', 'LastName': 'Kumordzie', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Young', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Solace M', 'Initials': 'SM', 'LastName': 'Tamakloe', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Brietta M', 'Initials': 'BM', 'LastName': 'Oaks', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, Rhode Island, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Arimond', 'Affiliation': 'Intake - Center for Dietary Assessment, FHI 360, Washington, DC, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12834']
376,30884006,Optimizing ablation duration using dormant conduction to reveal incomplete isolation with the second generation cryoballoon: A randomized controlled trial.,"INTRODUCTION
Efficacy of cryoballoon ablation depends on balloon-tissue contact and ablation duration. Prolonged duration may increase extracardiac complications. The aim of this study is to determine the optimal additional ablation duration after acute pulmonary vein isolation (PVI).
METHODS
Consecutive patients with paroxysmal AF were randomized to three groups according to additional ablation duration (90, 120, or 150 seconds) after acute PVI (time-to-isolation). Primary outcome was reconnection/dormant conduction (DC) after a 30 minutes waiting period. If present, additional 240 seconds ablations were performed. Ablations without time-to-isolation <90 seconds, esophageal temperature <18°C or decreased phrenic nerve capture were aborted. Patients were followed with 24-hour Holter monitoring at 3, 6, and 12 months.
RESULTS
Seventy-five study patients (60 ± 11 years, 48 male) were included. Reconnection/DC per vein significantly decreased (22%, 6% and 4%) while aborted ablations remained stable (respectively 4, 5, and 7%) among the 90, 120, and 150 seconds groups. A shorter cryo-application time, longer time-to-isolation, higher balloon temperature and unsuccessful ablations predicted reconnection/DC. Freedom of atrial fibrillation was, respectively, 52, 56, and 72% in 90, 120, and 150 seconds groups ( P = 0.27), while repeated procedures significantly decreased from 36% to 4% ( P = 0.041) in the longer duration group compared to shorter duration group (150 seconds vs 90 seconds group). In multivariate Cox-regression only reconnection/DC predicted recurrence.
CONCLUSION
Prolonging ablation duration after time-to-isolation significantly decreased reconnection/DC and repeated procedures, while recurrences and complications rates were similar. In a time-to-isolation approach, an additional ablation of 150 seconds ablation is the most appropriate.",2019,"Reconnection/DC per vein significantly decreased (22%, 6% and 4%) while aborted ablations remained stable (respectively 4, 5, and 7%) among the 90, 120, and 150 seconds groups.","['Consecutive patients with paroxysmal AF', 'Seventy-five study patients (60\u2009±\u200911 years, 48 male) were included']",['cryoballoon ablation'],"['extracardiac complications', 'balloon-tissue contact and ablation duration', 'reconnection/dormant conduction (DC', 'phrenic nerve capture', 'cryo-application time, longer time-to-isolation, higher balloon temperature and unsuccessful ablations predicted reconnection/DC', 'Reconnection/DC per vein', 'Freedom of atrial fibrillation', 'recurrences and complications rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C0031774', 'cui_str': 'Phrenic Nerve'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",75.0,0.056165,"Reconnection/DC per vein significantly decreased (22%, 6% and 4%) while aborted ablations remained stable (respectively 4, 5, and 7%) among the 90, 120, and 150 seconds groups.","[{'ForeName': 'Fehmi', 'Initials': 'F', 'LastName': 'Keçe', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'de Riva', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Naruse', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alizadeh Dehnavi', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Adrianus P', 'Initials': 'AP', 'LastName': 'Wijnmaalen', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Schalij', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Zeppenfeld', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Trines', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13913']
377,30903806,Linear growth faltering and the role of weight attainment: Prospective analysis of young children recovering from severe wasting in Niger.,"Efforts to reduce the impact of stunting have been largely independent of interventions to reduce the impact of wasting, despite the observation that the conditions can coexist in the same child and increase risk of death. To optimize the management of malnourished children-who can be wasted, stunted, or both-the relationship between stunting and wasting should be elaborated. We aimed to describe the relationship between concurrent weight and height gain during and after rehabilitation from severe wasting. We conducted a secondary analysis of a randomized trial for the outpatient treatment of severe wasting, including 1,542 children who recovered and were followed for 12 weeks. We described the overlap of stunting and severe wasting and the change in stunting over time. We showed the relationship between concurrent weight and height gain using adjusted generalized estimating equations and calculated the mean rate of change in weight-for-height z score (WHZ) and height-for-age z score (HAZ) during and after rehabilitation. At baseline, 79% (n = 1,223/1,542) and 49% (n = 757/1,542) of children were stunted and severely stunted, respectively. Prevalence increased over time among children <24 months. During rehabilitation when weight was not yet fully recovered, we found rapid WHZ gain but limited HAZ gain. Following successful rehabilitation, WHZ gain slowed. The rate of HAZ gain was negative after rehabilitation but increased relative to the period during treatment. The potential relationship between weight and height gain calls for increased coverage of wasting treatment to not only prevent child mortality but also reduce linear growth faltering.",2019,Prevalence increased over time among children <24 months.,"['young children recovering from severe wasting in Niger', 'outpatient treatment of severe wasting, including 1,542 children who recovered and were followed for 12\xa0weeks', 'malnourished children']",[],"['rate of HAZ gain', 'mean rate of change in weight-for-height z score (WHZ) and height-for-age z score (HAZ', 'concurrent weight and height gain', 'weight attainment']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0424670', 'cui_str': 'Weight for height (observable entity)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",1542.0,0.0423152,Prevalence increased over time among children <24 months.,"[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Isanaka', 'Affiliation': 'Departments of Nutrition and Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, United States.'}, {'ForeName': 'Matt D T', 'Initials': 'MDT', 'LastName': 'Hitchings', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, United States.'}, {'ForeName': 'Fatou', 'Initials': 'F', 'LastName': 'Berthé', 'Affiliation': 'Epicentre, Niger.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': 'Center for Child Health Research, University of Tampere School of Medicine, Tampere, Finland.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Grais', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}]",Maternal & child nutrition,['10.1111/mcn.12817']
378,30879731,The Protective Effect of Prenatal Social Support on Infant Adiposity in the First 18 Months of Life.,"OBJECTIVE
To determine whether prenatal social support was associated with infant adiposity in the first 18 months of life in a low-income, Hispanic sample, known to be at high risk of early child obesity.
STUDY DESIGN
We performed a longitudinal analysis of 262 low-income, Hispanic mother-infant pairs in the control group of the Starting Early child obesity prevention trial. Prenatal social support was measured using an item from the Maternal Social Support Index. We used multilevel modeling to predict weight-for-length z-score trajectories from birth to age 18 months and logistic regression to predict macrosomia and overweight status at ages 6, 12, and 18 months.
RESULTS
High prenatal social support was independently associated with lower infant adiposity trajectories from birth to age 18 months (B = -0.40; 95% CI, -0.63 to -0.16), a lower odds of macrosomia (aOR = 0.35; 95% CI, 0.15-0.80), and a lower odds of overweight at ages 12 (aOR = 0.28; 95% CI, 0.10-0.74) and 18 months (aOR = 0.35; 95% CI, 0.14-0.89). Prenatal social support was not significantly associated with overweight status at age 6 months.
CONCLUSIONS
Prenatal social support may protect against excessive infant adiposity and overweight in low-income, Hispanic families. Further research is needed to elucidate mechanisms underlying these associations and to inform preventive strategies beginning in pregnancy.",2019,"Prenatal social support was not significantly associated with overweight status at age 6 months.
","['262 low-income, Hispanic mother-infant pairs in the control group of the Starting Early child obesity prevention trial']",['Prenatal Social Support'],"['lower infant adiposity trajectories', 'Infant Adiposity', 'Prenatal social support']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",262.0,0.0244526,"Prenatal social support was not significantly associated with overweight status at age 6 months.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Katzow', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY. Electronic address: michelle.katzow@nyumc.org.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Scott', 'Affiliation': 'Department of Applied Statistics, Social Science, and Humanities, New York University Steinhardt School of Culture, Education, and Human Development, New York, NY.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.02.017']
379,31093657,Cardiovascular biomarkers in patients with acute decompensated heart failure randomized to sacubitril-valsartan or enalapril in the PIONEER-HF trial.,"AIMS
Circulating high-sensitivity cardiac troponin (hsTn) and soluble ST2 (sST2) reflect myocardial stress in patients with heart failure (HF). Production of cyclic guanosine 3'5' monophosphate (cGMP) in response to activation of natriuretic peptide receptors reduces cardiac afterload and preload. We assessed the effects of sacubitril/valsartan on these biomarkers in patients with reduced ejection fraction and acute decompensated HF (ADHF).
METHODS AND RESULTS
PIONEER-HF was a randomized, double-blind trial of sacubitril/valsartan vs. enalapril in hospitalized patients with ADHF following haemodynamic stabilization. We measured circulating hsTnT, sST2, and urinary cGMP at baseline, 1, 2 (sST2, cGMP), 4, and 8 weeks (n = 694 with all baseline biomarkers). Ratios of geometric means (timepoint/baseline) were determined and compared as a ratio for sacubitril/valsartan vs. enalapril. Compared with enalapril, sacubitril/valsartan led to a significantly greater decline in hsTnT and sST2. This effect emerged as early as 1 week for sST2 and was significant for both at 4 weeks with a 16% greater reduction in hsTnT (P < 0.001) and 9% greater reduction in sST2 (P = 0.0033). Serial urinary cGMP increased with sacubitril/valsartan compared with enalapril (P < 0.001, 1 week). The significant differences between treatment groups for each biomarker were sustained at 8 weeks. In an exploratory multivariable-adjusted analysis of cardiovascular death or HF-rehospitalization, the concentrations of hsTnT, sST2 at week 1 were significantly associated with subsequent outcome.
CONCLUSION
Biomarkers of myocardial stress are elevated in patients with ADHF and associated with outcome. Compared with enalapril, sacubitril/valsartan reduces myocardial injury and haemodynamic stress as reflected by biomarkers, with an onset that is apparent within 1-4 weeks.
CLINICAL TRIALS REGISTRATION
NCT02554890 clinical.trials.gov.",2019,"Serial urinary cGMP increased with sacubitril/valsartan compared with enalapril (P < 0.001, 1 week).","['patients with ADHF', 'patients with acute decompensated heart failure randomized to', 'patients with heart failure (HF', 'patients with reduced ejection fraction and acute decompensated HF (ADHF', 'hospitalized patients with ADHF following haemodynamic stabilization']","['sensitivity cardiac troponin (hsTn) and soluble ST2 (sST2', 'sacubitril/valsartan vs. enalapril', 'enalapril', ""cyclic guanosine 3'5' monophosphate (cGMP"", 'sacubitril-valsartan or enalapril', 'enalapril, sacubitril/valsartan', 'sacubitril/valsartan', 'valsartan vs. enalapril']","['Serial urinary cGMP', 'Cardiovascular biomarkers', 'circulating hsTnT, sST2, and urinary cGMP', 'decline in hsTnT and sST2', 'myocardial injury and haemodynamic stress', 'sST2', 'cardiovascular death or HF-rehospitalization, the concentrations of hsTnT, sST2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0450499', 'cui_str': 'ST2 (body structure)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0018330', 'cui_str': 'Guanosine'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.203051,"Serial urinary cGMP increased with sacubitril/valsartan compared with enalapril (P < 0.001, 1 week).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': 'TIMI Study Group, 75 Francis Street, Boston, MA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, 333 Cedar Street, New Haven, CT 06520-8056, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 2400 Pratt St, Durham, NC, USA.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Prescott', 'Affiliation': 'Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': 'TIMI Study Group, 75 Francis Street, Boston, MA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McCague', 'Affiliation': 'Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rocha', 'Affiliation': 'Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': 'TIMI Study Group, 75 Francis Street, Boston, MA, USA.'}]",European heart journal,['10.1093/eurheartj/ehz240']
380,31369090,Overeating Saturated Fat Promotes Fatty Liver and Ceramides Compared With Polyunsaturated Fat: A Randomized Trial.,"CONTEXT
Saturated fatty acid (SFA) vs polyunsaturated fatty acid (PUFA) may promote nonalcoholic fatty liver disease by yet unclear mechanisms.
OBJECTIVE
To investigate if overeating SFA- and PUFA-enriched diets lead to differential liver fat accumulation in overweight and obese humans.
DESIGN
Double-blind randomized trial (LIPOGAIN-2). Overfeeding SFA vs PUFA for 8 weeks, followed by 4 weeks of caloric restriction.
SETTING
General community.
PARTICIPANTS
Men and women who are overweight or have obesity (n = 61).
INTERVENTION
Muffins, high in either palm (SFA) or sunflower oil (PUFA), were added to the habitual diet.
MAIN OUTCOME MEASURES
Lean tissue mass (not reported here). Secondary and exploratory outcomes included liver and ectopic fat depots.
RESULTS
By design, body weight gain was similar in SFA (2.31 ± 1.38 kg) and PUFA (2.01 ± 1.90 kg) groups, P = 0.50. SFA markedly induced liver fat content (50% relative increase) along with liver enzymes and atherogenic serum lipids. In contrast, despite similar weight gain, PUFA did not increase liver fat or liver enzymes or cause any adverse effects on blood lipids. SFA had no differential effect on the accumulation of visceral fat, pancreas fat, or total body fat compared with PUFA. SFA consistently increased, whereas PUFA reduced circulating ceramides, changes that were moderately associated with liver fat changes and proposed markers of hepatic lipogenesis. The adverse metabolic effects of SFA were reversed by calorie restriction.
CONCLUSIONS
SFA markedly induces liver fat and serum ceramides, whereas dietary PUFA prevents liver fat accumulation and reduces ceramides and hyperlipidemia during excess energy intake and weight gain in overweight individuals.",2019,"SFA had no differential effect on the accumulation of visceral fat, pancreas fat or total body fat compared with PUFA.","['General community', 'overweight and obese humans', 'Participants: n=61 overweight or obese men and women']","['Saturated fat (SFA) versus polyunsaturated fat (PUFA', 'Overeating saturated fat promotes fatty liver and ceramides', 'Muffins high in either palm (SFA)- or sunflower oil (PUFA', 'Overfeeding SFA vs PUFA']","['liver fat or liver enzymes', 'blood lipids', 'SFA', 'body weight gain', 'liver and ectopic fat depots', 'Lean tissue mass', 'accumulation of visceral fat, pancreas fat or total body fat', 'liver fat content', 'adverse metabolic effects of SFA']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C2362518', 'cui_str': 'Polyunsaturated fat (substance)'}, {'cui': 'C0020505', 'cui_str': 'Polyphagia'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0452660', 'cui_str': 'Muffin (substance)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.090904,"SFA had no differential effect on the accumulation of visceral fat, pancreas fat or total body fat compared with PUFA.","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Rosqvist', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Kullberg', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ståhlman', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cedernaes', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Heurling', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Hans-Erik', 'Initials': 'HE', 'LastName': 'Johansson', 'Affiliation': 'Department of Public Health and Caring Sciences, Geriatrics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Iggman', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Wilking', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Eriksson', 'Affiliation': 'Antaros Medical AB, BioVenture Hub, Mölndal, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Straniero', 'Affiliation': 'Metabolism Unit, Endocrinology, Metabolism and Diabetes, and Integrated CardioMetabolic Center, Department of Medicine, Karolinska Institutet at Karolinska University Hospital, Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Rudling', 'Affiliation': 'Metabolism Unit, Endocrinology, Metabolism and Diabetes, and Integrated CardioMetabolic Center, Department of Medicine, Karolinska Institutet at Karolinska University Hospital, Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Antoni', 'Affiliation': 'Department of Medicinal Chemistry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lubberink', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Marju', 'Initials': 'M', 'LastName': 'Orho-Melander', 'Affiliation': 'Department of Clinical Sciences in Malmö, Lund University Diabetes Centre, Lund University, Malmö, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Borén', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ahlström', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Risérus', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00160']
381,32297449,Angiotensin receptor neprilysin inhibition versus individualized RAAS blockade: design and rationale of the PARALLAX trial.,"AIMS
Although the effect of the angiotensin receptor blocker neprilysin inhibitor (ARNI) sacubitril/valsartan on heart failure (HF) hospitalizations and cardiovascular death has been evaluated, its effects on functional capacity in patients with HF and ejection fraction (EF) >40% has yet to be determined. In addition, no prior studies have compared sacubitril/valsartan with angiotensin-converting enzyme inhibitor therapy. We sought to compare the effect of ARNI to background-medication-based individualized comparators (BMICs) on N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity [6 min walk distance (6MWD)], symptoms, and quality of life [Kansas City Cardiomyopathy Questionnaire (KCCQ)] in patients with HF and EF >40% in a randomized clinical trial.
METHODS
PARALLAX is a prospective, randomized, controlled, double-blind multicentre clinical trial in patients with chronic symptomatic HF with EF >40%, New York Heart Association (NYHA) class II-IV symptoms, elevated natriuretic peptides, and evidence of structural heart disease. Eligible patients are randomized to sacubitril/valsartan vs. BMIC for cardiovascular and related co-morbidities. BMIC includes (i) enalapril, (ii) valsartan, and (iii) placebo depending on the type of medical therapy prior to enrolment. The primary endpoints are the change in plasma NT-proBNP concentration from baseline to 12 weeks and the change from baseline in 6MWD distance at 24 weeks. The secondary endpoints assess quality of life and symptom burden.
CONCLUSIONS
PARALLAX will determine if sacubitril/valsartan compared with standard medical therapy for co-morbidities improves NT-proBNP levels, exercise capacity, quality of life, and symptom burden in HF patients with EF >40%.",2020,The primary endpoints are the change in plasma NT-proBNP concentration from baseline to 12 weeks and the change from baseline in 6MWD distance at 24 weeks.,"['patients with chronic symptomatic HF with EF >40%, New York Heart Association (NYHA) class II-IV symptoms, elevated natriuretic peptides, and evidence of structural heart disease', 'patients with HF and ejection fraction (EF) >40', 'patients with HF and EF']","['angiotensin receptor blocker neprilysin inhibitor (ARNI) sacubitril/valsartan', 'enalapril, (ii) valsartan, and (iii) placebo', 'sacubitril/valsartan vs. BMIC', 'ARNI to background-medication-based individualized comparators (BMICs']","['N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity [6 min walk distance (6MWD)], symptoms, and quality of life [Kansas City Cardiomyopathy Questionnaire (KCCQ', 'change in plasma NT-proBNP concentration', 'quality of life and symptom burden', 'NT-proBNP levels, exercise capacity, quality of life, and symptom burden']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.292114,The primary endpoints are the change in plasma NT-proBNP concentration from baseline to 12 weeks and the change from baseline in 6MWD distance at 24 weeks.,"[{'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Cowie', 'Affiliation': 'Faculty of Medicine, National Heart & Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szecsödy', 'Affiliation': 'Novartis, Basel, Switzerland.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis, East Hanover EastHanover NJ, USA.'}, {'ForeName': 'Ghionul', 'Initials': 'G', 'LastName': 'Ibram', 'Affiliation': 'Novartis, East Hanover EastHanover NJ, USA.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Novartis, Shanghai, China.'}, {'ForeName': 'Jianjian', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Novartis, East Hanover EastHanover NJ, USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Klebs', 'Affiliation': 'Novartis Pharma GmbH, Nuremberg, Germany.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin, Berlin, Germany.'}]",ESC heart failure,['10.1002/ehf2.12694']
382,32204554,Comparison between Acupuncture and Nutraceutical Treatment with Migratens ® in Patients with Fibromyalgia Syndrome: A Prospective Randomized Clinical Trial.,"OBJECTIVES
Fibromyalgia syndrome (FMS) is a chronic clinical condition characterized by pain, fatigue, altered sleep, and cognitive disturbances. The purpose of this study was to compare two alternative treatments (nutraceutical and acupuncture) in FMS patients through a randomized clinical trial.
RESEARCH METHODS
A total of 60 FMS female patients were randomized for treatment with a nutritional combination containing coenzyme Q10, vitamin D, alpha-lipoic acid, magnesium, and tryptophan (Migratens ® Group) or acupuncture treatment (Acupuncture Group) performed according the principles of traditional Chinese medicine (TCM), both for 3 months. Changes in pain and in quality of life (QoL) measured with a Fibromyalgia Impact Questionnaire Score-Revised (FIQ-R) and the Fibromyalgia Severity Scale (FSS) were performed at 1, 3, and 6 months after the start of treatments.
RESULTS
A total of 55 patient completed the study (21 in the Migratens ® Group and 34 in the Acupuncture Group). Migratens ® treatment shows a statistically significant reduction of pain 1 month after the start of therapy (T1, p = 0.025), strengthened after 3 months with maintenance of treatment (p = 0.012). The efficacy in reducing pain was apparent in the Acupuncture Group at all post-treatment determinations and at follow-up (T1 and T2 p = <0.001). Regarding QoL, improvement in FIQ-R and FSS values was revealed in both groups.
CONCLUSION
The nutraceutical approach with Migratens ® seems to be an effective option to for patients with FMS. Our experience confirmed also the validity of acupuncture in these patients. Considering the complexity of the management of FMS patients, our results suggest a cyclical and sequential, or even concurrent treatment with different approaches, to improve the efficacy and the compliance of patients to long-term treatment.",2020,The efficacy in reducing pain was apparent in the Acupuncture Group at all post-treatment determinations and at follow-up (T1 and T2 p = <0.001).,"['FMS patients', 'A total of 55 patient completed the study (21 in the Migratens ® Group and 34 in the Acupuncture Group', 'Fibromyalgia syndrome (FMS', 'Patients with Fibromyalgia Syndrome', 'patients with FMS', 'A total of 60 FMS female patients']","['nutritional combination containing coenzyme Q10, vitamin D, alpha-lipoic acid, magnesium, and tryptophan (Migratens ® Group) or acupuncture treatment (Acupuncture Group) performed according the principles of traditional Chinese medicine (TCM', 'alternative treatments (nutraceutical and acupuncture', 'Acupuncture and Nutraceutical Treatment with Migratens ®']","['pain', 'FIQ-R and FSS values', 'Fibromyalgia Impact Questionnaire Score-Revised (FIQ-R) and the Fibromyalgia Severity Scale (FSS', 'Changes in pain and in quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}]",60.0,0.0699422,The efficacy in reducing pain was apparent in the Acupuncture Group at all post-treatment determinations and at follow-up (T1 and T2 p = <0.001).,"[{'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Schweiger', 'Affiliation': 'Department of Surgery, Odontostomatology and Maternal Sciences, Fibromyalgia Diagnosis and Treatment Centre, University of Verona, 37134 Verona, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Secchettin', 'Affiliation': 'Department of Surgery and Oncology, General and Pancreatic Surgery, Pancreas Institute, University of Verona Hospital Trust, 37134 Verona, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Castellani', 'Affiliation': 'Department of Medicine, Regional Specialized Centre for Biomolecular and Histomorphometric Research on Skeletal and Degenerative Diseases, University of Verona, 37134 Verona, Italy.'}, {'ForeName': 'Alvise', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Department of Surgery, Odontostomatology and Maternal Sciences, Fibromyalgia Diagnosis and Treatment Centre, University of Verona, 37134 Verona, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Mazzocchi', 'Affiliation': 'Department of Medicine, Regional Specialized Centre for Biomolecular and Histomorphometric Research on Skeletal and Degenerative Diseases, University of Verona, 37134 Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, Neuromotor and Cognitive Rehabilitation Research Sciences, University of Verona, 37134 Verona, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Polati', 'Affiliation': 'Department of Surgery, Odontostomatology and Maternal Sciences, Fibromyalgia Diagnosis and Treatment Centre, University of Verona, 37134 Verona, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Donadello', 'Affiliation': 'Department of Surgery, Odontostomatology and Maternal Sciences, Fibromyalgia Diagnosis and Treatment Centre, University of Verona, 37134 Verona, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Valenti', 'Affiliation': 'Department of Medicine, Regional Specialized Centre for Biomolecular and Histomorphometric Research on Skeletal and Degenerative Diseases, University of Verona, 37134 Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dalle Carbonare', 'Affiliation': 'Department of Medicine, Regional Specialized Centre for Biomolecular and Histomorphometric Research on Skeletal and Degenerative Diseases, University of Verona, 37134 Verona, Italy.'}]",Nutrients,['10.3390/nu12030821']
383,31810378,Impact of Sleep Deprivation on Respiratory Motor Output and Endurance. A Physiological Study.,"Rationale: Sleep deprivation can alter endurance of skeletal muscles, but its impact on respiratory command is unknown. Objectives: We aimed to assess the effect of sleep deprivation on respiratory motor output and inspiratory endurance. Methods: Inspiratory endurance was investigated twice in random order, following a normal sleep night and a sleepless night. Healthy participants were asked to breathe as long as possible until task failure against a moderate inspiratory threshold constraint. Transdiaphragmatic pressure and diaphragm electrical activity were measured throughout the trial to assess pressure output of the diaphragm and overall respiratory motor output. Cortical contribution to respiratory motor output was assessed by measurement of preinspiratory motor potential amplitude and by cervical magnetic simulation. Measurements and Main Results: Twenty healthy male participants were studied. Time to task failure was significantly shorter after sleep deprivation than after normal sleep: (30 min [interquartile range [IQR], 17-41] vs. 60 min [IQR, 45-60], P = 0.002). At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4], P = 0.02) and correlated significantly with the duration of the endurance trial. In the sleep-deprivation condition, preinspiratory motor potential amplitude, electrical activity of the diaphragm, pressure output of the diaphragm, and Vt decreased and the respiratory rate increased significantly from the beginning to the end of the trial. Such decreases did not occur in the normal-sleep condition. Conclusions: One night of sleep deprivation reduces respiratory motor output by altering its cortical component with subsequent reduction of inspiratory endurance by half. These results suggest that altered sleep triggers severe brain dysfunctions that could precipitate respiratory failure.",2020,"At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4], P = 0.02) and correlated significantly with the duration of the endurance trial.","['Healthy participants', 'Twenty healthy male participants']","['Sleep Deprivation', 'sleep deprivation']","['sleep-deprivation condition', 'Time to task failure', 'Transdiaphragmatic pressure and diaphragm electrical activity', 'respiratory motor output and inspiratory endurance', 'Respiratory Motor Output and Endurance', 'sleep-deprivation condition, preinspiratory motor potential amplitude, electrical activity of the diaphragm, pressure output of the diaphragm, and Vt decreased and the respiratory rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0429441', 'cui_str': 'Motor-potential'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",20.0,0.107918,"At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4], P = 0.02) and correlated significantly with the duration of the endurance trial.","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Rault', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Sangaré', 'Affiliation': 'Service de Neurophysiologie Clinique.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Raux', 'Affiliation': 'Sorbonne Universités, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Similowski', 'Affiliation': 'Sorbonne Universités, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Drouot', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201904-0819OC']
384,30814669,Influence of training protocols on text input speed on a computer in individuals with cervical spinal cord injury: a randomised controlled trial.,"STUDY DESIGN
Randomised controlled trial.
OBJECTIVES
To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective.
SETTING
Rehabilitation department, Garches, France.
METHODS
Participants with neurological levels between C6 and C8 were allocated to one of three different groups. The REHAB group underwent training with an occupational therapist. The SELF group carried out a standardised home self-training with a written training guide. The CONTROL group had no training. Participants were assessed at day 15 (D15) and day 30 (D30). The primary outcome was a copying task with and without WPS (WITH and WITHOUT).
RESULTS
Forty-two participants (mean age ± SD of 39.8 ± 12) were included and 38 completed the study. At D30, the mean (95% confidence interval) difference in TIS between the CONTROL and SELF groups was 3.8 [-1.7 to 9.4] characters per minute (cpm) (p = 0.23), between the REHAB and SELF groups was 12.9 [7.4 to 18.4] cpm (p < 0.001), and between the REHAB and CONTROL groups was 9.1 [3.5 to 14.6] cpm (p < 0.001).
CONCLUSIONS
The results of this study showed that occupational therapist-supervised training improved TIS but word prediction software did not increase TIS. These results suggest that supervised training should be provided to all individuals who are prescribed with devices and systems to facilitate computer access in order to increase their TIS.",2019,"To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective.
","['Participants with neurological levels between C6 and C8', 'individuals with cervical spinal cord injury', 'people with tetraplegia', 'Forty-two participants (mean age\u2009±\u2009SD of 39.8\u2009±\u200912) were included and 38 completed the study', 'Rehabilitation department, Garches, France']","['training protocols', 'word prediction software (WPS) training protocols', 'standardised home self-training with a written training guide', 'training with an occupational therapist']","['TIS', 'text input speed (TIS', 'copying task with and without WPS (WITH and WITHOUT']","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}]",,0.0702357,"To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective.
","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'New Technologies Plate-Form, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France. samuel.pouplin@aphp.fr.'}, {'ForeName': 'Djamel', 'Initials': 'D', 'LastName': 'Bensmail', 'Affiliation': 'New Technologies Plate-Form, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vaugier', 'Affiliation': 'Clinical Innovations Centre 1429, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Axelle', 'Initials': 'A', 'LastName': 'Gelineau', 'Affiliation': 'New Technologies Plate-Form, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pottier', 'Affiliation': 'Clinical Innovations Centre 1429, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular Diseases, University of Versailles, St-Quentin-en-Yvelines, France.'}]",Spinal cord,['10.1038/s41393-019-0265-5']
385,31121022,Effects of alirocumab on types of myocardial infarction: insights from the ODYSSEY OUTCOMES trial.,"AIMS
The third Universal Definition of Myocardial Infarction (MI) Task Force classified MIs into five types: Type 1, spontaneous; Type 2, related to oxygen supply/demand imbalance; Type 3, fatal without ascertainment of cardiac biomarkers; Type 4, related to percutaneous coronary intervention; and Type 5, related to coronary artery bypass surgery. Low-density lipoprotein cholesterol (LDL-C) reduction with statins and proprotein convertase subtilisin-kexin Type 9 (PCSK9) inhibitors reduces risk of MI, but less is known about effects on types of MI. ODYSSEY OUTCOMES compared the PCSK9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome (ACS) and elevated LDL-C (≥1.8 mmol/L) despite intensive statin therapy. In a pre-specified analysis, we assessed the effects of alirocumab on types of MI.
METHODS AND RESULTS
Median follow-up was 2.8 years. Myocardial infarction types were prospectively adjudicated and classified. Of 1860 total MIs, 1223 (65.8%) were adjudicated as Type 1, 386 (20.8%) as Type 2, and 244 (13.1%) as Type 4. Few events were Type 3 (n = 2) or Type 5 (n = 5). Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77-0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77-0.99; P = 0.032) and Type 2 (0.77, 0.61-0.97; P = 0.025), but not Type 4 MI.
CONCLUSION
After ACS, alirocumab added to intensive statin therapy favourably impacted on Type 1 and 2 MIs. The data indicate for the first time that a lipid-lowering therapy can attenuate the risk of Type 2 MI. Low-density lipoprotein cholesterol reduction below levels achievable with statins is an effective preventive strategy for both MI types.",2019,"Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77-0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77-0.99; P = 0.032) and Type 2 (0.77, 0.61-0.97; P = 0.025), but not Type 4 MI.
CONCLUSION
","['18\xa0924 patients with recent acute coronary syndrome (ACS) and elevated LDL-C (≥1.8\u2009mmol/L) despite intensive statin therapy', 'spontaneous; Type 2, related to oxygen supply/demand imbalance; Type 3, fatal without ascertainment of cardiac biomarkers; Type 4, related to percutaneous coronary intervention; and Type 5, related to coronary artery bypass surgery', 'Median follow-up was 2.8\u2009years']","['alirocumab', 'alirocumab with placebo', 'PCSK9 inhibitor', 'lipid-lowering therapy']",['myocardial infarction'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441732', 'cui_str': 'Type 4 (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0457499', 'cui_str': 'Type 5 (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",18924.0,0.0929233,"Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77-0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77-0.99; P = 0.032) and Type 2 (0.77, 0.61-0.97; P = 0.025), but not Type 4 MI.
CONCLUSION
","[{'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, 5 Park Road, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), an F-CRIN network, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université Paris-Diderot, Sorbonne Paris-Cité, INSERM U-1148, 46 rue Henri Huchard, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'Department of Epidemiology and Biostatistics, SUNY Downstate Medical Center School of Public Health, 450 Clarkson Avenue, Brooklyn, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, 75 Francis Street, Boston, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, 701 19th Street South - LHRB 310, Birmingham, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Paraguay 160, Rosario, Santa Fe, Argentina.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'Sanofi, 55 Corporate Drive, Bridgewater, USA.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, University of Latvia, Pilsonu Street 13, Riga, Latvia.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, 2-132 Li Ka Shing Centre for Health Research Innovation University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hanotin', 'Affiliation': 'Sanofi, 54-56 Rue la Boétie, Paris, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, 300 Pasteur Drive, S-102, Stanford, CA, USA.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, RC Leiden, The Netherlands.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, 200 Morris Street, Durham, NC, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Grant S-102, Stanford, CA, USA.'}, {'ForeName': 'Angele', 'Initials': 'A', 'LastName': 'Moryusef', 'Affiliation': 'Sanofi, 55 Corporate Drive, Bridgewater, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, 777 Old Saw Mill River Road, Tarrytown, NY, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, 200 Morris Street, Durham, NC, USA.'}, {'ForeName': 'Piyamitr', 'Initials': 'P', 'LastName': 'Sritara', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Ramathibodi Hospital/Mahidol University, Rama VI Road, Thailand.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Tricoci', 'Affiliation': 'CSL Behring, 1100 N Miami Blvd Ste 613, Durham, NC, USA.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Theodor-Stern-Kai 7, Frankfurt am Main, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, 1700 N. Wheeling Street, Aurora, CO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehz299']
386,31612956,Cannabis and Alcohol Co-Use in a Smoking Cessation Pharmacotherapy Trial for Adolescents and Emerging Adults.,"INTRODUCTION
The co-use of cannabis and alcohol among tobacco-using youth is common. Alcohol co-use is associated with worse tobacco cessation outcomes, but results are mixed regarding the impact of cannabis on tobacco outcomes and if co-use leads to increased use of non-treated substances. This secondary analysis from a youth smoking cessation trial aimed to (1) evaluate the impact of cannabis or alcohol co-use on smoking cessation, (2) examine changes in co-use during the trial, and (3) explore secondary effects of varenicline on co-use.
METHODS
The parent study was a 12-week, randomized clinical trial of varenicline for smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White). Daily cigarette, cannabis, and alcohol use data were collected via daily diaries during treatment and Timeline Follow-back for 14 weeks post-treatment.
RESULTS
Baseline cannabis co-users (68%) had double the odds of continued cigarette smoking throughout the trial compared with noncannabis users, which was pronounced in males and frequent cannabis users. Continued smoking during treatment was associated with higher probability of concurrent cannabis use. Baseline alcohol co-users (80%) did not have worse smoking outcomes compared with nonalcohol users, but continued smoking was associated with higher probability of concurrent drinking. Varenicline did not affect co-use.
CONCLUSIONS
Inconsistent with prior literature, results showed that alcohol co-users did not differ in smoking cessation, whereas cannabis co-users had poorer cessation outcomes. Youth tobacco treatment would benefit from added focus on substance co-use, particularly cannabis, but may need to be tailored appropriately to promote cessation.
IMPLICATIONS
Among youth cigarette smokers enrolled in a pharmacotherapy evaluation clinical trial, alcohol and/or cannabis co-use was prevalent. The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation. Reductions in smoking were accompanied by concurrent reductions in alcohol or cannabis use. Substance co-use does not appear to affect all youth smokers in the same manner and treatment strategies may need to be tailored appropriately for those with lower odds of smoking cessation.",2019,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","['youth cigarette smokers', 'Adolescents and Emerging Adults', 'smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White']","['varenicline', 'cannabis or alcohol co-use', 'Varenicline']",['cigarette smoking'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}]",,0.0318818,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Squeglia', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz170']
387,30608521,"Ambulatory heart rate reduction after catheter-based renal denervation in hypertensive patients not receiving anti-hypertensive medications: data from SPYRAL HTN-OFF MED, a randomized, sham-controlled, proof-of-concept trial.","AIMS
The randomized sham-controlled SPYRAL HTN-OFF MED trial demonstrated that renal denervation (RDN) using a multi-electrode catheter lowers ambulatory blood pressure (BP) in non-medicated hypertensive patients. The current report describes the effects of RDN on heart rate (HR) in this population.
METHODS AND RESULTS
Patients were enrolled with an office systolic BP (SBP) of ≥150 mmHg and <180 mmHg, office diastolic BP (DBP) of ≥90 mmHg, and a mean ambulatory SBP of ≥140 mmHg and <170 mmHg. Patients were drug naïve or removed from their anti-hypertensive medications. Eighty patients were randomized 1:1 to RDN or sham procedure. This post hoc analysis examines the effect at 3 months of RDN on HR and of high baseline 24-h HR on BP and HR changes. There was a significant reduction in 24-h HR at 3 months for the RDN group (-2.5 b.p.m.) compared with sham (-0.2 b.p.m.), P = 0.003 (analysis of covariance). Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026). RDN patients with baseline 24-h HR above the median (73.5 b.p.m.) had significant reductions in average ambulatory SBP (-10.7 mmHg difference, P = 0.001) and DBP (-7.5 mmHg, P < 0.001), whereas BP changes in RDN patients with below-median HRs were not significant.
CONCLUSION
Average and minimum morning HR were significantly reduced at 3 months for RDN compared with sham patients. A baseline 24-h HR above the median predicted greater BP reductions and may allow physicians to select patients likely to respond to the procedure.",2019,"Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026).","['Eighty patients', 'Patients were drug naïve or removed from their anti-hypertensive medications', 'hypertensive patients not receiving anti-hypertensive medications', 'Patients were enrolled with an office systolic BP (SBP) of ≥150\u2009mmHg and <180\u2009mmHg, office diastolic BP (DBP) of ≥90\u2009mmHg, and a mean ambulatory SBP of ≥140\u2009mmHg and <170\u2009mmHg', 'non-medicated hypertensive patients']","['RDN or sham procedure', 'RDN', 'renal denervation (RDN) using a multi-electrode catheter', 'catheter-based renal denervation']","['average ambulatory SBP', 'DBP', 'Average and minimum morning HR', 'heart rate (HR', 'Ambulatory heart rate reduction', 'BP and HR changes', '24-h HR', 'minimum morning HR', 'ambulatory blood pressure (BP', 'BP reductions', 'BP changes']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1292747', 'cui_str': 'Removes from'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.100608,"Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Kirrberger Street 1, Homburg/Saar, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Kirrberger Street 1, Homburg/Saar, Germany.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Department of Interventional Cardiology, Piedmont Heart Institute, 275 Collier Rd NW #500, Atlanta, GA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel St, Bloomsbury, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ukena', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Kirrberger Street 1, Homburg/Saar, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'Department of Medicine, SUNY Downstate College of Medicine, 450 Clarkson Ave, Brooklyn, NY, USA.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hoshide', 'Affiliation': 'Department of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Tochigi-ken, Japan.'}, {'ForeName': 'Manesh', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiology, Duke University Medical Center, 2301 Erwin Road, Durham, NC, USA.'}, {'ForeName': 'Crystal C', 'Initials': 'CC', 'LastName': 'Tyson', 'Affiliation': 'Department of Internal Medicine, Duke University Medical Center, 2301 Erwin Road, Durham, NC, USA.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Weil', 'Affiliation': 'Department of Cardiology, Sana Cardiomed Heart Center, Kronsforder Allee 71, Lübeck, Germany.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Agdirlioglu', 'Affiliation': 'Department of Cardiology, Sana Cardiomed Heart Center, Kronsforder Allee 71, Lübeck, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fahy', 'Affiliation': 'Medtronic PLC, Santa Rosa, CA, USA.'}, {'ForeName': 'Kazuomo', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Department of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Tochigi-ken, Japan.'}]",European heart journal,['10.1093/eurheartj/ehy871']
388,31942688,Weight Loss and Vomiting 1 Year After Banded Versus Non-banded One Anastomosis Gastric Bypass: a Prospective Randomized Trial.,"BACKGROUND
The weight loss outcomes after banded one-anastomosis gastric bypass (OAGB) remain to be determined.
OBJECTIVE
To compare weight loss and vomiting 1 year after banded versus non-banded OAGB.
METHODS
This is a prospective, open-label, randomized study, which evaluated 33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12 months. Weight loss (percentages of total weight loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting were assessed and compared before surgery and after 6 and 12 months.
RESULTS
At baseline, there were no differences between groups in regard to age, gender, and body mass index (BMI). At 6 and 12 months post-op, and the overall mean %TWL regardless of band use was 22.4 ± 7% and 29 ± 6.9%, respectively, and the overall average %EWL regardless of band use was 66.8 ± 22.9% and 86.3 ± 24%, respectively. %TWL did not differ between the banded and non-banded groups at 6 (21.8 ± 6.8% vs. 23.1 ± 7.4%; p = 0.7) and 12 months post-op (27.5 ± 6.6% vs. 30.4 ± 7.1%; p = 0.3), as well as %EWL at 6 (67 ± 22.9% vs. 67.6 ± 23.6%; p = 0.6) and 12 months post-op (83.5 ± 24.4% vs. 89 ± 24.1%; p = 0.4). The occurrence of vomiting did not significantly differ between banded and non-banded OAGB at 6 (12.5% vs. 11.8%; p = 0.9) and 12 months post-op (12.5% vs. 5.9%; p = 0.5).
CONCLUSION
OAGB led to an overall satisfactory weight loss after 1 year, regardless of band use. Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.",2020,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"['33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12\xa0months']","['OAGB', 'Banded Versus Non-banded One Anastomosis Gastric Bypass']","['weight loss and vomiting 1\xa0year', 'overall satisfactory weight loss', 'weight loss nor more vomiting', 'Weight Loss and Vomiting 1 Year', 'occurrence of vomiting', 'Weight loss (percentages of total weight', 'loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0252491,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"[{'ForeName': 'Everton', 'Initials': 'E', 'LastName': 'Cazzo', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil. notrevezzo@yahoo.com.'}, {'ForeName': 'Laísa Simakawa', 'Initials': 'LS', 'LastName': 'Jimenez', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Felipe Gilberto', 'Initials': 'FG', 'LastName': 'Valerini', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Tiago Bezerra', 'Initials': 'TB', 'LastName': 'de Freitas Diniz', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Elinton Adami', 'Initials': 'EA', 'LastName': 'Chaim', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04393-8']
389,32125522,Effect of music on labor and delivery in nulliparous singleton pregnancies: a randomized clinical trial.,"BACKGROUND
Women's experience of pain during labor varies greatly, and pain control is a major concern for obstetricians. Several methods have been studied for pain management for women in labor, including drug and non-drug interventions.
OBJECTIVE
To test the hypothesis that in nulliparous women with singleton pregnancies at term, listening to music would reduce the pain level during labor.
METHODS
Parallel group non-blinded randomized clinical trial conducted at a single center in Italy. Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted in labor and delivery room between 37 0/7 and 42 0/7 weeks of gestation for active phase of labor were eligible, and were randomized in a 1:1 ratio to receive music during labor or no music during labor. Music in labor was defined listening to music from the randomization until the delivery of the baby. The primary endpoint was the pain level during the active phase of labor, recorded using the visual analogue scale (VAS) for pain, ranging from 0 (no pain) to 10 (unbearable pain). The effect of music use during labor on each outcome was quantified as the mean difference (MD) with 95% confidence interval (CI).
RESULTS
During the study period, 30 women agree to take part in the study, underwent randomization, and were enrolled and followed up. 15 women were randomized in the music group, and 15 in the control group. No patients were lost to follow up for the primary outcome. Pain level during the active phase of labor was scored 8.8 ± 0.9 in the music group, and 9.8 ± 0.3 in the control group (MD - 1.00 point, 95% CI - 1.48 to - 0.52; P < 0.01). Music during labor and delivery was also associated with a decreased pain at 1 h postpartum (MD - 2.40 points, 95% CI - 4.30 to - 0.50), and decreased anxiety level during active phase of labor (MD - 19.90 points, 95% CI - 38.72 to - 1.08), second stage of labor (MD - 49.40 points, 95% CI - 69.44 to - 29.36), and at 1 h postpartum (MD - 27.00 points, 95% CI - 47.37 to - 6.63).
CONCLUSION
In nulliparous women with singleton pregnancies at term, listening to music reduces the pain level, and the anxiety level during labor.
TRIAL REGISTRATION
Clinicaltrials.gov NCT03779386.",2020,"In nulliparous women with singleton pregnancies at term, listening to music reduces the pain level, and the anxiety level during labor.
","['nulliparous singleton pregnancies', 'nulliparous women with singleton pregnancies', 'Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted in labor and delivery room between 37 0/7 and 42 0/7\xa0weeks of gestation for active phase of labor were eligible', '15 women', '30 women agree to take part in the study, underwent randomization, and were enrolled and followed up']","['music', 'music during labor or no music during labor']","['pain level, and the anxiety level', 'anxiety level', 'pain level', 'pain level during the active phase of labor, recorded using the visual analogue scale (VAS) for pain, ranging from 0 (no pain) to 10 (unbearable pain', 'Pain level', 'pain']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0233260', 'cui_str': 'Vertex presentation (finding)'}, {'cui': 'C0011212', 'cui_str': 'Centers, Hospital Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0234225', 'cui_str': 'No pain'}]",15.0,0.413189,"In nulliparous women with singleton pregnancies at term, listening to music reduces the pain level, and the anxiety level during labor.
","[{'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Buglione', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mas', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Raffone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy. anton.raffone@gmail.com.'}, {'ForeName': 'Lavinia', 'Initials': 'L', 'LastName': 'Di Meglio', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'di Meglio', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Toscano', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Travaglino', 'Affiliation': 'Pathology Unit, Department of Woman and Child Health, Agostino Gemelli University Polyclinic, Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Zapparella', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Marzia', 'Initials': 'M', 'LastName': 'Duval', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Zullo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Mariavittoria', 'Initials': 'M', 'LastName': 'Locci', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05475-9']
390,31391297,Effects of Exercise on Chemotherapy Completion and Hospitalization Rates: The OptiTrain Breast Cancer Trial.,"BACKGROUND
Exercise during chemotherapy is suggested to provide clinical benefits, including improved chemotherapy completion. Despite this, few randomized controlled exercise trials have reported on such clinical endpoints. From the OptiTrain trial we previously showed positive effects on physiological and health-related outcomes after 16 weeks of supervised exercise in patients with breast cancer undergoing chemotherapy. Here, we examined the effects of exercise on rates of chemotherapy completion and hospitalization, as well as on blood cell concentrations during chemotherapy.
PATIENTS AND METHODS
Two hundred forty women scheduled for chemotherapy were randomized to 16 weeks of resistance and high-intensity interval training (RT-HIIT), moderate-intensity aerobic and high-intensity interval training (AT-HIIT), or usual care (UC). Outcomes included chemotherapy completion, hospitalization, hemoglobin, lymphocyte, thrombocyte, and neutrophil concentrations during chemotherapy.
RESULTS
No significant between-groups differences were found in the proportion of participants who required dose reductions (RT-HIIT vs. UC: odds ratio [OR], 1.08; AT-HIIT vs. UC: OR, 1.39), or average relative dose intensity of chemotherapy between groups (RT-HIIT vs. UC: effect size [ES], 0.08; AT-HIIT vs. UC: ES, -0.07). A significantly lower proportion of participants in the RT-HIIT group (3%) were hospitalized during chemotherapy compared with UC (15%; OR, 0.20). A significantly lower incidence of thrombocytopenia was found for both RT-HIIT (11%) and AT-HIIT (10%) versus UC (30%; OR, 0.27; OR, 0.27).
CONCLUSION
No beneficial effects of either RT-HIIT or AT-HIIT on chemotherapy completion rates were found. However, combined resistance training and high-intensity interval training were effective to reduce hospitalization rates, and both exercise groups had a positive effect on thrombocytopenia. These are important findings with potential positive implications for the health of women with breast cancer and costs associated with treatment-related complications.
IMPLICATIONS FOR PRACTICE
Completing the prescribed chemotherapy regimen is strongly associated with a good prognosis for patients with primary breast cancer. Despite this, treatment-induced side effects make it necessary to reduce or alter the treatment regimen and can also lead to hospitalization. Exercise during chemotherapy is suggested to provide clinical benefits, including improved chemotherapy completion. This study showed that combined resistance and high-intensity interval training during chemotherapy resulted in lower hospitalization rates and a lower incidence of thrombocytopenia in women with breast cancer undergoing chemotherapy. However, no beneficial effects of either exercise program on chemotherapy completion rates were found, which is in contrast to previous findings in this population. The findings reported in the current article have positive implications for the health of women with breast cancer and costs associated with treatment-related complications.",2020,"A significantly lower incidence of thrombocytopenia was found for both RT-HIIT (11%) and AT-HIIT (10%) versus UC (30%; OR, 0.27; OR, 0.27).
","['patients with breast cancer undergoing chemotherapy', 'patients with primary breast cancer', 'Two hundred forty women scheduled for', 'women with breast cancer undergoing chemotherapy']","['supervised exercise', 'resistance and high-intensity interval training (RT-HIIT), moderate-intensity aerobic and high-intensity interval training (AT-HIIT), or usual care (UC', 'combined resistance training and high-intensity interval training', 'Exercise', 'exercise program', 'chemotherapy']","['chemotherapy completion, hospitalization, hemoglobin, lymphocyte, thrombocyte, and neutrophil concentrations during chemotherapy', 'blood cell concentrations', 'thrombocytopenia', 'hospitalization rates', 'chemotherapy completion rates', 'Chemotherapy Completion and Hospitalization Rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005773', 'cui_str': 'Blood Corpuscles'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",240.0,0.0961471,"A significantly lower incidence of thrombocytopenia was found for both RT-HIIT (11%) and AT-HIIT (10%) versus UC (30%; OR, 0.27; OR, 0.27).
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mijwel', 'Affiliation': 'Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Bolam', 'Affiliation': 'Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Gerrevall', 'Affiliation': 'Department of Cell and Molecular Biology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Foukakis', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Rundqvist', 'Affiliation': 'Department of Cell and Molecular Biology, Karolinska Institutet, Stockholm, Sweden.'}]",The oncologist,['10.1634/theoncologist.2019-0262']
391,32212983,"Efficacy and safety of coenzyme A versus fenofibrate in patients with hyperlipidemia: a multicenter, double-blind, double-mimic, randomized clinical trial.","Background: We investigated the lipid-lowering efficacy and safety of coenzyme A (CoA) versus fenofibrate in Chinese patients with moderate dyslipidemia. Methods: A total of 417 subjects (aged 18-75 years) diagnosed with moderate dyslipidemia (triglyceride 2.3-6.5 mmol/L) from 13 large cardiovascular centers in China were recruited and randomly divided into a fenofibrate group ( n = 207), which received 200 mg of fenofibrate orally once daily, and a CoA group ( n = 210), which received 400 mg of CoA orally once a day. Blood lipoproteins, liver and renal function, creatine kinase, and blood glucose were measured at baseline, and after 4 and 8 weeks of treatment. Results: The baseline triglyceride (TG) level in the fenofibrate group and the CoA group was 3.39 ± 0.99 mmol/L and 3.60 ± 1.11 mmol/L, respectively. After treatment for 4 and 8 weeks with fenofibrate, TG was reduced by 31.62% and 33.13%. In the CoA group, TG was reduced by 17.29% and 23.80%. Compared with baseline, total cholesterol (TC) was significantly decreased in both groups after either 4 or 8 weeks of treatment ( p < .05). CoA increased high-density lipoprotein cholesterol (HDL-C) after 4 weeks of treatment, whereas it had no significant effect on HDL-C after 8 weeks of treatment. Low-density lipoprotein cholesterol (LDL-C) was not modified in either group. The incidence of side effects was significantly lower in the CoA group compared with the fenofibrate group ( p < .05). Conclusions: Compared with fenofibrate, CoA has less effect on reducing plasma TG levels in subjects with moderate dyslipidemia. However, it has fewer adverse effects.",2020,"Compared with baseline, total cholesterol (TC) was significantly decreased in both groups after either 4 or 8 weeks of treatment (P < 0.05).","['patients with hyperlipidemia', 'subjects with moderate dyslipidemia', '417 subjects (aged 18-75 years) diagnosed with moderate dyslipidemia (triglyceride, 2.3-6.5\u2009mmol/L) from 13 large cardiovascular centers in China', 'Chinese patients with moderate dyslipidemia']","['fenofibrate, CoA', 'Coenzyme A versus fenofibrate', 'coenzyme A (CoA) versus fenofibrate', 'fenofibrate']","['Efficacy and safety', 'Blood lipoproteins, liver and renal function, creatine kinase, and blood glucose', 'high-density lipoprotein cholesterol (HDL-C', 'total cholesterol (TC', 'TG', 'baseline triglyceride (TG) level', 'Low-density lipoprotein cholesterol (LDL-C', 'HDL-C', 'plasma TG levels', 'incidence of side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0009226', 'cui_str': 'Coenzyme A'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005768'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",417.0,0.203314,"Compared with baseline, total cholesterol (TC) was significantly decreased in both groups after either 4 or 8 weeks of treatment (P < 0.05).","[{'ForeName': 'Ya-Qin', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Shui-Ping', 'Initials': 'SP', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hui-Jun', 'Initials': 'HJ', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Current medical research and opinion,['10.1080/03007995.2020.1747416']
392,31765640,Impact of treatment for fecal incontinence on constipation symptoms.,"OBJECTIVE
Defecatory symptoms, such as a sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence. Treatments for fecal incontinence, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for fecal incontinence with education only, loperamide, anal muscle exercises with biofeedback or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and nonresponders to fecal incontinence treatment.
STUDY DESIGN
This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for fecal incontinence in a 2 × 2 factorial design. Women with at least monthly fecal incontinence and normal stool consistency were randomized to 4 groups: (1) oral placebo plus education only, (2) oral loperamide plus education only, (3) placebo plus anorectal manometry-assisted biofeedback, and (4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms questionnaire at baseline, 12 weeks, and 24 weeks. The Patient Assessment of Constipation Symptoms consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to fecal incontinence treatment were defined as women with a minimally important clinical improvement of ≥5 points on the St Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in Patient Assessment of Constipation Symptoms scores from baseline through 24 weeks.
RESULTS
At 24 weeks, there were small changes in Patient Assessment of Constipation Symptoms global scores in all 4 groups: oral placebo plus education (-0.3; 95% confidence interval, -0.5 to -0.1), loperamide plus education (-0.1, 95% confidence interval, -0.3 to0.0), oral placebo plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2), and loperamide plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2). No differences were observed in change in Patient Assessment of Constipation Symptoms scores between women randomized to placebo plus education and those randomized to loperamide plus education (P = .17) or placebo plus biofeedback (P = .82). Change in Patient Assessment of Constipation Symptoms scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in Patient Assessment of Constipation Symptoms scores than nonresponders (-0.4; 95% confidence interval, -0.5 to -0.3 vs -0.2; 95% confidence interval, -0.3 to -0.0, P < .01, mean difference, 0.2, 95% confidence interval, 0.1-0.4).
CONCLUSION
Change in constipation symptoms following treatment of fecal incontinence in women are small and are not significantly different between groups. Loperamide treatment for fecal incontinence does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in fecal incontinence symptoms report greater improvement in constipation symptoms.",2020,No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82).,"['Women with at least monthly FI and normal stool consistency', 'Fecal Incontinence on Constipation Symptoms', 'women with fecal incontinence (FI', 'women undergoing treatment for FI with education only', 'women with normal consistency stool']","['placebo', 'placebo plus biofeedback', 'loperamide, anal muscle exercises with biofeedback, or both loperamide and biofeedback', 'combination loperamide plus biofeedback therapy', 'oral placebo plus education only, 2) oral loperamide plus education only, 3) placebo plus anorectal manometry-assisted biofeedback and 4) loperamide plus biofeedback']","['PAC-SYM scores', 'PAC-SYM global scores', 'constipation symptoms', 'loperamide plus biofeedback', 'FI symptoms', 'loperamide plus education', 'Constipation Symptoms (PAC-SYM) questionnaire', 'global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps', ""St. Mark's (Vaizey) scale"", 'Defecatory symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332530', 'cui_str': 'Normal consistency (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3652856', 'cui_str': 'loperamide, combinations'}, {'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0426739', 'cui_str': 'Stool size'}, {'cui': 'C0558921', 'cui_str': 'Rectal symptoms (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0222045'}]",,0.676002,No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82).,"[{'ForeName': 'Uduak U', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA. Electronic address: uduakumoh.andy@uphs.upenn.edu.'}, {'ForeName': 'J Eric', 'Initials': 'JE', 'LastName': 'Jelovsek', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Isuzu', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Keisha Y', 'Initials': 'KY', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': ""Department of Women's Health, Dell Medical School, University of Texas at Austin. Austin, TX; University of New Mexico Health Sciences Center, Albuquerque, NM.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Korbly', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Sassani', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.11.1256']
393,32166877,Effect of adding azithromycin to the antimalarials used for seasonal malaria chemoprevention on the nutritional status of African children.,"OBJECTIVES
Mass administration of azithromycin has reduced mortality in children in sub-Saharan Africa but its mode of action is not well characterised. A recent trial found that azithromycin given alongside seasonal malaria chemoprevention was not associated with a reduction in mortality or hospital admissions in young children. We investigated the effect of azithromycin on the nutritional status of children enrolled in this study.
METHODS
A total of 19 578 children in Burkina Faso and Mali were randomised to receive either azithromycin or placebo alongside seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine monthly for three malaria transmission seasons (2014-2016). After each transmission season, anthropometric measurements were collected from approximately 4000 randomly selected children (2000 per country) at a cross-sectional survey and used to derive nutritional status indicators. Binary and continuous outcomes between treatment arms were compared by Poisson and linear regression.
RESULTS
Nutritional status among children was poor in both countries with evidence of acute and chronic malnutrition (24.9-33.3% stunted, 15.8-32.0% underweight, 7.2-26.4% wasted). There was a suggestion of improvement in nutritional status in Burkina Faso and deterioration in Mali over the study period. At the end of each malaria transmission season, nutritional status of children did not differ between treatment arms (seasonal malaria chemoprevention plus azithromycin or placebo) in either the intention-to-treat or per-protocol analyses (only children with at least three cycles of SMC in the current intervention year).
CONCLUSIONS
The addition of azithromycin to seasonal malaria chemoprevention did not result in an improvement of nutritional outcomes in children in Burkina Faso and Mali.",2020,The addition of azithromycin to seasonal malaria chemoprevention did not result in an improvement of nutritional outcomes in children in Burkina Faso and Mali.,"['African Children', '19,578 children in Burkina Faso and Mali', 'children in Burkina Faso and Mali', 'young children', 'children enrolled in this study']","['azithromycin', 'Azithromycin', 'azithromycin or placebo', 'sulfadoxine-pyrimethamine plus amodiaquine']","['nutritional outcomes', 'acute and chronic malnutrition', 'mortality or hospital admissions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",19578.0,0.0562404,The addition of azithromycin to seasonal malaria chemoprevention did not result in an improvement of nutritional outcomes in children in Burkina Faso and Mali.,"[{'ForeName': 'Georgia R', 'Initials': 'GR', 'LastName': 'Gore-Langton', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cairns', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Yves Daniel', 'Initials': 'YD', 'LastName': 'Compaoré', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Mariken M', 'Initials': 'MM', 'LastName': 'de Wit', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Barry', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Nikiema', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'R Serge', 'Initials': 'RS', 'LastName': 'Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Rosemonde M', 'Initials': 'RM', 'LastName': 'Guissou', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Ouedraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13390']
394,31088784,"Does soccer headgear reduce the incidence of sport-related concussion? A cluster, randomised controlled trial of adolescent athletes.","BACKGROUND
There have been no large randomised controlled trials to determine whether soccer headgear reduces the incidence or severity of sport-related concussion (SRC) in US high school athletes.
OBJECTIVE
We aimed to determine whether headgear reduces the incidence or severity (days out from soccer) of SRCs in soccer players.
METHODS
2766 participants (67% female, age 15.6±1.2) (who undertook 3050 participant years) participated in this cluster randomised trial. Athletes in the headgear (HG) group wore headgear during the season, while those in the no headgear (NoHG) group did not. Staff recorded SRC and non-SRC injuries and soccer exposures. Multivariate Cox proportional hazards models were used to examine time-to-SRC between groups, while severity was compared with a Wilcoxon rank-sum test.
RESULTS
130 participants (5.3% female, 2.2% male) sustained an SRC. The incidence of SRC was not different between the HG and NoHG groups for males (HR: 2.00 (0.63-6.43) p=0.242) and females (HR: 0.86 (0.54-1.36) p=0.520). Days lost from SRC were not different (p=0.583) between the HG group (13.5 (11.0-018.8) days) and the NoHG group (13.0 (9.0-18.8) days).
CONCLUSIONS
Soccer headgear did not reduce the incidence or severity of SRC in high school soccer players.
TRIAL REGISTRATION NUMBER
NCT02850926.",2020,"Days lost from SRC were not different (p=0.583) between the HG group (13.5 (11.0-018.8) days) and the NoHG group (13.0 (9.0-18.8) days).
","['adolescent athletes', 'soccer players', '2766', 'participants (67% female, age 15.6±1.2) (who undertook 3050 participant years', '130 participants (5.3% female, 2.2% male) sustained an SRC']",[],"['incidence of SRC', 'incidence or severity of SRC']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",2766.0,0.255826,"Days lost from SRC were not different (p=0.583) between the HG group (13.5 (11.0-018.8) days) and the NoHG group (13.0 (9.0-18.8) days).
","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McGuine', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Wisconsin Madison, Madison, Wisconsin, USA mcguine@ortho.wisc.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Post', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Adam Yakuro', 'Initials': 'AY', 'LastName': 'Pfaller', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hetzel', 'Affiliation': 'Biostatistics and Medical Informatics, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Schwarz', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'M Alison', 'Initials': 'MA', 'LastName': 'Brooks', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Kliethermes', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Wisconsin Madison, Madison, Wisconsin, USA.'}]",British journal of sports medicine,['10.1136/bjsports-2018-100238']
395,32087337,N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial.,"Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone. Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. The study described in this paper addresses this knowledge gap by testing the efficacy of N-acetylcysteine (NAC) in reducing alcohol use and PTSD symptoms. Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. NAC is a cysteine pro-drug that stimulates the cystine-glutamate exchanger, normalizes glial glutamate transporters, and restores glutamatergic tone on presynaptic receptors in reward regions of the brain. Moreover, NAC is available over-the-counter, has a long-established safety record, and does not require titration to achieve the target dose. This paper describes the rationale, study design, and methodology of a 12-week, randomized, double-blind, placebo-controlled trial of NAC (2400 mg/day) among adults with co-occurring AUD and PTSD. Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS) are utilized to investigate the neural circuitry and neurochemistry underlying comorbid AUD/PTSD and identify predictors of treatment outcome. This study is designed to determine the efficacy of NAC in the treatment of co-occurring AUD/PTSD and provide new information regarding mechanisms of action implicated in co-occurring AUD/PTSD.",2020,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"['adults with co-occurring AUD and PTSD', 'comorbid alcohol use disorder and posttraumatic stress disorder']","['placebo', 'NAC', 'N-acetylcysteine', 'Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS', 'N-acetylcysteine (NAC']",['alcohol use and PTSD symptoms'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0324161,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Santa Ana', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: santaana@musc.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jonjen@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jarnecka@musc.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: priscian@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: browdg@musc.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Taimina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: taimina@musc.edu.'}, {'ForeName': 'Ebele', 'Initials': 'E', 'LastName': 'Compean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: malcolmr@musc.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Kalivas', 'Affiliation': 'Department of Neuroscience, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kalivasp@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105961']
396,32291607,Effect of Thick-Needle Therapy in Patients with Bell's Palsy at Recovery Stage: A Multi-center Randomized Controlled Trial.,"OBJECTIVE
To compare the clinical effects of thick-needle therapy (TNT) and acupuncture therapy (AT) on patients with Bell's palsy (BP) at the recovery stage.
METHODS
A total of 146 eligible participants from 3 hospitals in China were randomized into the TNT group (73 cases) and the AT group (73 cases) using a central randomization. Both groups received Western medicine thrice a day for 4 weeks. Moreover, patients in the TNT group received subcutaneous insertion of a thick needle into Shendao (GV 11) acupoint, while patients in the AT group received AT at acupoints of Cuanzhu (BL 2), Yangbai (GB 14), Dicang (ST 4), Xiaguan (ST 7), Jiache (ST 6), Yingxiang (LI 20) and Hegu (LI 4), 4 times a week, for 4 weeks. Both groups received 2 follow-up visits, which were arranged at 1 month and 3 months after treatment, respectively. The primary outcome measure was House-Brackmann Facial Nerve Grading System (HBFNGS) grade. And the clinical recovery rates of both groups were evaluated according to the HBFNGS grades after treatment. The secondary outcome measures included the facial disability index (FDI) and electroneurogram (EnoG). The adverse events were observed and recorded in both groups.
RESULTS
Three cases withdrew from the trial, 2 in the TNT group and 1 in the AT group. There was no signifificant difference in the clinical recovery rates between the TNT and AT groups after 4-week treatment [40.85% (29/71) vs. 34.72% (25/72), P>0.05]. At the 2nd follow-up visit, more patients in the TNT group showed reduced HBFNGS grades than those in the AT group (P<0.01). No significant difference was observed between the two groups in FDI score, EnoG latency and maximum amplitude ratio at all time points (all P>0.05).
CONCLUSION
The clinical effect of TNT was equivalent to that of AT in patients with BP at recovery stage, while the post-treatment effect of TNT was superior to that of AT. (Registration No. ChiCTR-INR-16008409).",2020,"No significant difference was observed between the two groups in FDI score, EnoG latency and maximum amplitude ratio at all time points (all P>0.05).
","['146 eligible participants from 3 hospitals in China', ""Patients with Bell's Palsy at Recovery Stage"", ""patients with Bell's palsy (BP) at the recovery stage"", 'patients with BP at recovery stage']","['TNT', 'Western medicine', 'subcutaneous insertion of a thick needle into Shendao (GV 11) acupoint', 'thick-needle therapy (TNT) and acupuncture therapy (AT', 'Thick-Needle Therapy', 'AT at acupoints of Cuanzhu (BL 2), Yangbai (GB 14), Dicang (ST 4), Xiaguan (ST 7), Jiache (ST 6), Yingxiang (LI 20) and Hegu']","['adverse events', 'clinical recovery rates', 'facial disability index (FDI) and electroneurogram (EnoG', 'reduced HBFNGS grades', 'FDI score, EnoG latency and maximum amplitude ratio', 'House-Brackmann Facial Nerve Grading System (HBFNGS) grade']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",146.0,0.0739477,"No significant difference was observed between the two groups in FDI score, EnoG latency and maximum amplitude ratio at all time points (all P>0.05).
","[{'ForeName': 'Bin-Yan', 'Initials': 'BY', 'LastName': 'Yu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310000, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Hong-Cai', 'Initials': 'HC', 'LastName': 'Shang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, 100700, China.'}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Yi-Jia', 'Initials': 'YJ', 'LastName': 'Wan', 'Affiliation': 'Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310000, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'The Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Xuan', 'Affiliation': 'Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310000, China. xlh1083@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3081-z']
397,32294940,"Effects of a Traditional versus an Alternative Strengthening Exercise Program on Shoulder Pain, Function and Physical Performance in Individuals with Subacromial Shoulder Pain: A Randomized Controlled Trial.","A manual shoulder-training device may represent an alternative training device to improve symptoms and function in patients with subacromial shoulder pain by strengthening the external rotators. Thus, we examined the effects of a traditional versus an alternative strengthening exercise program on shoulder pain/function and physical performance in individuals with subacromial shoulder pain. Fifty-six adults with subacromial shoulder pain were randomly assigned to a passive control group (CON; n = 20), a traditional training group (TRA; n = 19), or an alternative training group (ALT; n = 17). Both training groups conducted a progressive home-based strengthening exercise program for the external rotators for eight weeks using elastic bands only (TRA group) or in combination with the shoulder-training device (Schulterhilfe®) (ALT group). Pre- and post-training assessment included measures of shoulder pain/function (i.e., shoulder pain and disability index (SPADI)) and physical performance (i.e., shoulder flexibility, maximal isometric strength, and strength endurance). We found significant test × group interactions in most of the investigated variables. Post hoc analyses showed significant training-related improvements for proxies of shoulder pain/function, shoulder flexibility, maximal isometric strength, and strength endurance in favor of the ALT and TRA group in comparison to the CON group. Further, larger and more frequent effects were found for the ALT compared to the TRA group. Measures of shoulder pain/function and physical performance can be significantly improved by both training regimens in individuals with subacromial shoulder pain. However, strength training using elastic bands with the manual shoulder device (ALT group) as compared to elastic bands (TRA group) only was more effective and may thus be a recommendable alternative in order to mitigate subacromial shoulder pain.",2020,"Post hoc analyses showed significant training-related improvements for proxies of shoulder pain/function, shoulder flexibility, maximal isometric strength, and strength endurance in favor of the ALT and TRA group in comparison to the CON group.","['Fifty-six adults with subacromial shoulder pain', 'patients with subacromial shoulder pain by strengthening the external rotators', 'Individuals with Subacromial Shoulder Pain', 'individuals with subacromial shoulder pain']","['elastic bands only (TRA group) or in combination with the shoulder-training device (Schulterhilfe®) (ALT group', 'ALT', 'passive control group (CON; n = 20), a traditional training group (TRA; n = 19), or an alternative training group (ALT', 'CON', 'TRA', 'traditional versus an alternative strengthening exercise program', 'progressive home-based strengthening exercise program', 'Traditional versus an Alternative Strengthening Exercise Program']","['shoulder pain/function (i.e., shoulder pain and disability index (SPADI)) and physical performance (i.e., shoulder flexibility, maximal isometric strength, and strength endurance', 'shoulder pain/function and physical performance', 'proxies of shoulder pain/function, shoulder flexibility, maximal isometric strength, and strength endurance', 'Shoulder Pain, Function and Physical Performance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}]",56.0,0.0230212,"Post hoc analyses showed significant training-related improvements for proxies of shoulder pain/function, shoulder flexibility, maximal isometric strength, and strength endurance in favor of the ALT and TRA group in comparison to the CON group.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schedler', 'Affiliation': 'Division of Movement and Training Sciences/Biomechanics of Sports, University of Duisburg-Essen, 45141 Essen, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Brueckner', 'Affiliation': 'Division of Movement and Training Sciences/Biomechanics of Sports, University of Duisburg-Essen, 45141 Essen, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Hagen', 'Affiliation': 'Division of Movement and Training Sciences/Biomechanics of Sports, University of Duisburg-Essen, 45141 Essen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muehlbauer', 'Affiliation': 'Division of Movement and Training Sciences/Biomechanics of Sports, University of Duisburg-Essen, 45141 Essen, Germany.'}]","Sports (Basel, Switzerland)",['10.3390/sports8040048']
398,32056676,Long-term effects of web-based pedometer-mediated intervention on COPD exacerbations.,"BACKGROUND
Technology-based physical activity (PA) interventions have been shown to improve daily step counts and health-related quality of life, but their effect on long-term clinical outcomes like acute exacerbations (AEs) is unknown in persons with COPD.
METHODS
U.S. Veterans with stable COPD were randomized (1:1) to either pedometer alone (control) or pedometer plus a website with feedback, goal-setting, disease education, and a community forum (intervention) for 3 months. AEs were assessed every 3 months over a follow-up period of approximately 15 months. Pedometer-assessed daily step counts, health-related quality-of-life (HRQL), and self-efficacy were assessed at baseline, end-of-intervention at 3 months, and during follow-up approximately 6 and 12 months after enrollment. Zero-inflated Poisson models assessed the effect of the intervention on risk for AEs, compared to controls. Generalized linear mixed-effects models for repeated measures examined between-group and within-group changes in daily step count, HRQL, and self-efficacy.
RESULTS
There were no significant differences in age, FEV 1 % predicted, baseline daily step count, AEs the year prior to enrollment, or duration of follow-up between the intervention (n = 57) and control (n = 52) groups. The intervention group had a significantly reduced risk of AEs (rate ratio = 0.51, [95%CI 0.31-0.85]), compared to the control group. There were no significant between-group differences in change in average daily step count, HRQL, or self-efficacy at 6 and 12 months after enrollment.
CONCLUSIONS
A 3-month internet-mediated, pedometer-based PA intervention was associated with reduced risk for AEs of COPD over 12-15 months of follow-up. ClinicalTrials.gov identifier: NCT01772082.",2020,"There were no significant between-group differences in change in average daily step count, HRQL, or self-efficacy at 6 and 12 months after enrollment.
","['U.S. Veterans with stable COPD', 'persons with COPD']","['Technology-based physical activity (PA) interventions', 'pedometer alone (control) or pedometer plus a website with feedback, goal-setting, disease education, and a community forum (intervention', 'web-based pedometer-mediated intervention']","['daily step count, HRQL, and self-efficacy', 'average daily step count, HRQL, or self-efficacy', 'Pedometer-assessed daily step counts, health-related quality-of-life (HRQL), and self-efficacy', 'COPD exacerbations', 'reduced risk for AEs of COPD', 'risk of AEs']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]",57.0,0.125038,"There were no significant between-group differences in change in average daily step count, HRQL, or self-efficacy at 6 and 12 months after enrollment.
","[{'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Wan', 'Affiliation': ""Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA; Channing Division of Network Medicine, Brigham & Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kantorowski', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Kadri', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gagnon', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA; Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Garshick', 'Affiliation': ""Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA; Channing Division of Network Medicine, Brigham & Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: marilyn.moy@va.gov.'}]",Respiratory medicine,['10.1016/j.rmed.2020.105878']
399,30952510,Evaluating the Use of a Decision Aid for Parents Facing Extremely Premature Delivery: A Randomized Trial.,"OBJECTIVE
To assess decisional conflict and knowledge about prematurity among mothers facing extreme premature delivery when the counseling clinicians were randomized to counsel using a validated decision aid compared with usual counseling.
STUDY DESIGN
In this randomized trial, clinicians at 5 level III neonatal intensive care units in the US were randomized to supplement counseling using the decision aid or to counsel mothers in their usual manner. We enrolled mothers with threatened premature delivery at 22 0/7 to 25 6/7 weeks of gestation within 7 days of their counseling. The primary outcome was the Decisional Conflict Scale (DCS) score. One hundred mothers per group were enrolled to detect a clinically relevant effect size of 0.4 in the Decisional Conflict Scale. Secondary outcomes included knowledge about prematurity; scores on the Preparedness for Decision Making scale; and acceptability.
RESULTS
Ninety-two clinicians were randomized and 316 mothers were counseled. Of these, 201 (64%) mothers were enrolled. The median gestational age was 24.1 weeks (IQR 23.7-24.9). In both groups, DCS scores were low (16.3 ± 18.2 vs 16.8 ± 17, P = .97) and Preparedness for Decision Making scores were high (73.4 ± 28.3 vs 70.5 ± 31.1, P = .33). There was a significantly greater knowledge score in the decision aid group (66.2 ± 18.5 vs 57.2 ± 18.8, P = .005). Most clinicians and parents found the decision aid useful.
CONCLUSIONS
For parents facing extremely premature delivery, use of a decision aid did not impact maternal decisional conflict, but it significantly improved knowledge of complex information. A structured decision aid may improve comprehension of complex information.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT01713894.",2019,"For parents facing extremely premature delivery, use of a decision aid did not impact maternal decisional conflict, but it significantly improved knowledge of complex information.","['Ninety-two clinicians were randomized and 316 mothers were counseled', 'clinicians at 5 level III neonatal intensive care units in the US', 'Parents Facing Extremely Premature Delivery', 'mothers facing extreme premature delivery when the counseling clinicians', 'enrolled mothers with threatened premature delivery at 22 0/7 to 25 6/7 \xa0weeks of gestation within 7\xa0days of their counseling', 'One hundred mothers per group', '201 (64%) mothers were enrolled']",['supplement counseling using the decision aid or to counsel mothers in their usual manner'],"['knowledge about prematurity; scores on the Preparedness for Decision Making scale; and acceptability', 'median gestational age', 'knowledge score', 'Decisional Conflict Scale (DCS) score', 'DCS scores', 'Preparedness for Decision Making scores']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0441927', 'cui_str': 'Level III (tumor staging)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0222045'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}]",92.0,0.140622,"For parents facing extremely premature delivery, use of a decision aid did not impact maternal decisional conflict, but it significantly improved knowledge of complex information.","[{'ForeName': 'Úrsula', 'Initials': 'Ú', 'LastName': 'Guillén', 'Affiliation': 'Division of Neonatology, Christiana Care Health System, Newark, DE. Electronic address: uguillen@christianacare.org.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Mackley', 'Affiliation': 'Division of Neonatology, Christiana Care Health System, Newark, DE.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Laventhal', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kukora', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Christ', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Derrick', 'Affiliation': 'Division of Neonatology, NorthShore University Health System, Evanston, IL.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Batza', 'Affiliation': 'Division of Neonatology, NorthShore University Health System, Evanston, IL.'}, {'ForeName': 'Sarvin', 'Initials': 'S', 'LastName': 'Ghavam', 'Affiliation': 'Division of Neonatology, Virtua Voorhees Hospital, Voorhees Township, NJ.'}, {'ForeName': 'Haresh', 'Initials': 'H', 'LastName': 'Kirpalani', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.02.023']
400,32250707,Improving Notifiable Disease Case Reporting Through Electronic Information Exchange-Facilitated Decision Support: A Controlled Before-and-After Trial.,"OBJECTIVE
Outbreak detection and disease control may be improved by simplified, semi-automated reporting of notifiable diseases to public health authorities. The objective of this study was to determine the effect of an electronic, prepopulated notifiable disease report form on case reporting rates by ambulatory care clinics to public health authorities.
METHODS
We conducted a 2-year (2012-2014) controlled before-and-after trial of a health information exchange (HIE) intervention in Indiana designed to prepopulate notifiable disease reporting forms to providers. We analyzed data collected from electronic prepopulated reports and ""usual care"" (paper, fax) reports submitted to a local health department for 7 conditions by using a difference-in-differences model. Primary outcomes were changes in reporting rates, completeness, and timeliness between intervention and control clinics.
RESULTS
Provider reporting rates for chlamydia and gonorrhea in intervention clinics increased significantly from 56.9% and 55.6%, respectively, during the baseline period (2012) to 66.4% and 58.3%, respectively, during the intervention period (2013-2014); they decreased from 28.8% and 27.5%, respectively, to 21.7% and 20.6%, respectively, in control clinics ( P < .001). Completeness improved from baseline to intervention for 4 of 15 fields in reports from intervention clinics ( P < .001), although mean completeness improved for 11 fields in both intervention and control clinics. Timeliness improved for both intervention and control clinics; however, reports from control clinics were timelier (mean, 7.9 days) than reports from intervention clinics (mean, 9.7 days).
CONCLUSIONS
Electronic, prepopulated case reporting forms integrated into providers' workflow, enabled by an HIE network, can be effective in increasing notifiable disease reporting rates and completeness of information. However, it was difficult to assess the effect of using the forms for diseases with low prevalence (eg, salmonellosis, histoplasmosis).",2020,"Completeness improved from baseline to intervention for 4 of 15 fields in reports from intervention clinics ( P < .001), although mean completeness improved for 11 fields in both intervention and control clinics.",['Indiana designed to prepopulate notifiable disease reporting forms to providers'],"['health information exchange (HIE) intervention', 'Electronic Information Exchange-Facilitated Decision Support']","['mean completeness', 'changes in reporting rates, completeness, and timeliness between intervention and control clinics', 'chlamydia and gonorrhea in intervention clinics']","[{'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C3849995', 'cui_str': 'Medical Information Exchange'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}]",,0.0402737,"Completeness improved from baseline to intervention for 4 of 15 fields in reports from intervention clinics ( P < .001), although mean completeness improved for 11 fields in both intervention and control clinics.","[{'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Dixon', 'Affiliation': '10668 Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Zuoyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': '50826 Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, IN, USA.'}, {'ForeName': 'Janet N', 'Initials': 'JN', 'LastName': 'Arno', 'Affiliation': '12250 School of Medicine, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Revere', 'Affiliation': '7284 School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joseph Gibson', 'Affiliation': '4059 Marion County Public Health Department, Indianapolis, IN, USA.'}, {'ForeName': 'Shaun J', 'Initials': 'SJ', 'LastName': 'Grannis', 'Affiliation': '50826 Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, IN, USA.'}]","Public health reports (Washington, D.C. : 1974)",['10.1177/0033354920914318']
401,32227753,Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease.,"BACKGROUND
In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients.
METHODS
We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency.
RESULTS
At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina).
CONCLUSIONS
In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","['Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease', 'patients with stable ischemic heart disease and moderate or severe ischemia']",['invasive treatment strategy (2295 participants) or a conservative strategy'],"['angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ', 'SAQ summary score (scores range', 'SAQ summary scores', 'angina-related health status']","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",,0.248293,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Jones', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Weintraub', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Khaula', 'Initials': 'K', 'LastName': 'Baloch', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916370']
402,32295808,Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial.,"OBJECTIVE
To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).
RESEARCH DESIGN AND METHODS
In this phase 3, open-label, multicenter trial, 321 patients with HbA 1c ≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA 1c at week 26.
RESULTS
Change in HbA 1c from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference -1.07% [-11.7 mmol/mol], P < 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA 1c <7% (53 mmol/mol) (65.2% vs. 19.4%; P < 0.0001), and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference -2.29 mmol/L [-41.23 mg/dL], P < 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.
CONCLUSIONS
This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.",2020,"This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.","['Japanese patients with T2DM', 'insulin-naïve Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs', 'Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs', '321 patients with HbA 1c ≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL']","['1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide', 'iGlarLixi or Lixi', 'insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi', 'iGlarLixi']","['Efficacy and Safety', 'FPG reductions', 'change in HbA 1c', 'rates of treatment-emergent adverse events', 'Incidence of documented symptomatic hypoglycemia', 'efficacy and safety', 'severe hypoglycemic events', 'Incidence of gastrointestinal events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4293375', 'cui_str': 'insulin glargine and lixisenatide'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",321.0,0.0516409,"This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan hwatada@juntendo.ac.jp.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Takami', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spranger', 'Affiliation': 'Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Amano', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}]",Diabetes care,['10.2337/dc19-2452']
403,32291277,Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes.,"OBJECTIVE
To determine the effect of tirzepatide, a dual agonist of glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 receptors, on biomarkers of nonalcoholic steatohepatitis (NASH) and fibrosis in patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS
Patients with T2DM received either once weekly tirzepatide (1, 5, 10, or 15 mg), dulaglutide (1.5 mg), or placebo for 26 weeks. Changes from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST), keratin-18 (K-18), procollagen III (Pro-C3), and adiponectin were analyzed in a modified intention-to-treat population.
RESULTS
Significant ( P < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks. Decreases with tirzepatide were significant compared with placebo for K-18 (10 mg) and Pro-C3 (15 mg) and with dulaglutide for ALT (10, 15 mg). Adiponectin significantly increased from baseline with tirzepatide compared with placebo (10, 15 mg).
CONCLUSIONS
In post hoc analyses, higher tirzepatide doses significantly decreased NASH-related biomarkers and increased adiponectin in patients with T2DM.",2020,"RESULTS
Significant ( P < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks.","['patients with T2DM', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes mellitus (T2DM', 'Patients with T2DM received either once weekly']","['tirzepatide', 'placebo', 'dulaglutide', 'Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide', 'AST']","['NASH-related biomarkers and increased adiponectin', 'alanine aminotransferase (ALT), aspartate aminotransferase (AST), keratin-18 (K-18), procollagen III (Pro-C3), and adiponectin', 'Adiponectin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0071997', 'cui_str': 'Pro-Complement 3'}]",,0.0602816,"RESULTS
Significant ( P < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks.","[{'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hartman', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN hartman_mark_l@lilly.com.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, Department of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Wilson', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nikooienejad', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Bray', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Chrisanthi A', 'Initials': 'CA', 'LastName': 'Karanikas', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Duffin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Robins', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haupt', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}]",Diabetes care,['10.2337/dc19-1892']
404,32071118,Results of a Randomized Phase IIb Trial of Nelipepimut-S + Trastuzumab versus Trastuzumab to Prevent Recurrences in Patients with High-Risk HER2 Low-Expressing Breast Cancer.,"PURPOSE
Preclinical data provide evidence for synergism between HER2-targeted peptide vaccines and trastuzumab. The efficacy of this combination was evaluated in patients with HER2 low-expressing breast cancer in the adjuvant setting.
PATIENTS AND METHODS
A phase IIb, multicenter, randomized, single-blinded, controlled trial enrolled disease-free patients after standard therapy completion (NCT01570036). Eligible patients were HLA-A2, A3, A24, and/or A26+, and had HER2 IHC 1+/2+, FISH nonamplified breast cancer, that was node positive and/or hormone receptor-negative [triple-negative breast cancer (TNBC)]. Patients received trastuzumab for 1 year and were randomized to placebo (GM-CSF, control) or nelipepimut-S (NPS) with GM-CSF. Primary outcome was 24-month disease-free survival (DFS). Secondary outcomes were 36-month DFS, safety, and immunologic response.
RESULTS
Overall, 275 patients were randomized; 136 received NPS with GM-CSF, and 139 received placebo with GM-CSF. There were no clinicopathologic differences between groups. Concurrent trastuzumab and NPS with GM-CSF was safe with no additional overall or cardiac toxicity compared with control. At median follow-up of 25.7 (interquartile range, 18.4-32.7) months, estimated DFS did not significantly differ between NPS and control [HR, 0.62; 95% confidence interval (CI), 0.31-1.25; P = 0.18]. In a planned exploratory analysis of patients with TNBC, DFS was improved for NPS versus control (HR, 0.26; 95% CI, 0.08-0.81, P = 0.01).
CONCLUSIONS
The combination of NPS with trastuzumab is safe. In HER2 low-expressing breast cancer, no significant difference in DFS was seen in the intention-to-treat analysis; however, significant clinical benefit was seen in patients with TNBC. These findings warrant further investigation in a phase III randomized trial.",2020,"In HER2 low-expressing breast cancer, no significant difference in DFS was seen in the intention-to-treat analysis; however, significant clinical benefit was seen in TNBC patients.","['high-risk HER2 low-expressing breast cancer patients', '275 patients were randomized; 136 received', 'HER2 low-expressing breast cancer patients in the adjuvant setting', 'Eligible patients were HLA-A2, A3, A24, and/or A26+, and had HER2 immunohistochemistry 1+/2+, FISH nonamplified breast cancer, that was node positive and/or hormone receptor negative (triple negative breast cancer [TNBC']","['placebo with GM-CSF', 'NPS with trastuzumab', 'NPS with GM-CSF', 'nelipepimut-S + trastuzumab vs trastuzumab', 'placebo (granulocyte-macrophage colony-stimulating factor [GM-CSF], control) or nelipepimut-S (NPS) with GM-CSF', 'trastuzumab', 'Concurrent trastuzumab and NPS with GM-CSF']","['DFS', '24-month disease-free survival (DFS', 'cardiac toxicity', '36-month DFS, safety, and immunologic response', 'estimated DFS']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0019733', 'cui_str': 'HLA-A2'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0876994', 'cui_str': 'Cardiac Toxicity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",275.0,0.140496,"In HER2 low-expressing breast cancer, no significant difference in DFS was seen in the intention-to-treat analysis; however, significant clinical benefit was seen in TNBC patients.","[{'ForeName': 'G Travis', 'Initials': 'GT', 'LastName': 'Clifton', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hale', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Vreeland', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Annelies T', 'Initials': 'AT', 'LastName': 'Hickerson', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Gheath', 'Initials': 'G', 'LastName': 'Alatrash', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rashmi K', 'Initials': 'RK', 'LastName': 'Murthy', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Qiao', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Philips', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Lukas', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle Cancer Care Alliance, Issaquah, Washington.'}, {'ForeName': 'Jarrod P', 'Initials': 'JP', 'LastName': 'Holmes', 'Affiliation': 'Department of Medical Oncology, St. Joseph Health Cancer Center, Santa Rosa, California.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Peoples', 'Affiliation': 'Department of Surgery, Uniformed Services Health University, Bethesda, Maryland. emittendorf@bwh.harvard.edu gpeoples@cancerinsight.com.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. emittendorf@bwh.harvard.edu gpeoples@cancerinsight.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2741']
405,31981043,Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,"BACKGROUND
Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC).
OBJECTIVE
Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC.
METHODS
A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain.
RESULTS
Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14 months of follow-up with a crossover at 6 months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
CONCLUSION
Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.",2020,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","['After Gastric Bypass Surgery', 'Forty-two patients']","['Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation', 'APC', 'SHAM']","['quality of life', 'satiety and greater weight loss', 'weight loss', 'EQ5D VAS scale', 'effectiveness and safety', 'total mean weight loss', 'weight loss, the return of early satiation', 'relapse of obesity occurs', 'Weight Regain']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034380'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0222045'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",42.0,0.0503247,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04414-6']
406,32289804,A Single Motivational Lecture Can Promote Modest Weight Loss: A Randomized Controlled Trial.,"BACKGROUND
Obesity is a public health problem worldwide. To widely disseminate weight-loss interventions across the target population, a cost-effective approach is needed.
OBJECTIVE
We aimed to test whether a single motivational lecture could promote weight loss.
METHODS
Our study was a 3-month randomized controlled trial, and we recruited participants via local newspaper advertisements in 3 cities in Ibaraki Prefecture, Japan, and randomly assigned them to a control group (no intervention) and an intervention group, who attended a single motivational lecture lasting approximately 2 h. No other lectures or textbooks were provided. The eligibility criteria included an age of 40-64 years, a body mass index (BMI) of 25-40 kg/m2, and the presence of at least 1 component of metabolic syndrome. The primary outcome was body weight change at 3 months.
RESULTS
We enrolled 145 eligible participants with a mean age of 53.8 ± 7.1 years and a BMI of 28.5 ± 3.1 kg/m2. The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively. The between-group difference was 1.83 kg (95% CI 1.15-2.51).
CONCLUSIONS
The significant difference suggested that a single motivational lecture is an effective option to promote modest weight loss in the short term.",2020,"The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively.","['participants via local newspaper advertisements in 3 cities in Ibaraki Prefecture, Japan', '145 eligible participants with a mean age of 53.8 ± 7.1 years and a BMI of 28.5 ± 3.1 kg/m2', 'The eligibility criteria included an age of 40-64 years, a body mass index (BMI) of 25-40 kg/m2, and the presence of at least 1 component of metabolic syndrome']","['Motivational Lecture', 'control group (no intervention) and an intervention group, who attended a single motivational lecture lasting approximately 2 h', 'single motivational lecture']","['body weight change at 3 months', 'Modest Weight Loss', 'weight loss', '3-month body weight change']","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",145.0,0.202298,"The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively.","[{'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan, nakata.yoshio.gn@u.tsukuba.ac.jp.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasai', 'Affiliation': 'Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Tsujimoto', 'Affiliation': 'Faculty of Human Sciences, Shimane University, Matsue, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}]",Obesity facts,['10.1159/000506813']
407,32291608,Clinical Efficacy and Transcriptomic Analysis of Congrong Shujing Granules () in Patients with Parkinson's Disease and Syndrome of Shen (Kidney) Essence Deficiency.,"OBJECTIVE
To evaluate the clinical efficacy and safety of Congrong Shujing Granules ( , CSGs) in treating patients with Parkinson's disease (PD) and Chinese medicine (CM) syndrome of Shen (Kidney) essence deficiency, and to investigate the potential mechanism involving efficacy through a transcriptome sequencing approach.
METHODS
Eligible PD patients with syndrome of Shen essence defificiency were randomly assigned to a treatment group or a control group by a random number table, and were treated with CSGs combined with Western medicine (WM), or placebo combined with WM, respectively. Both courses of treatment lasted for 12 weeks. The Unifified Parkinson's Disease Rating Scale (UPDRS) score, the PD Question-39 (PDQ-39) score, CM Syndrome Scale score, and drug usage of all patients were evaluated before and after treatment. Safety was evaluated by clinical laboratory tests and electrocardiographs. Blood samples from 6 patients in each group were collected before and after the trial and used for transcriptomic analysis by gene ontology analysis and Kyoto Encyclopedia of Genes and Genomes pathway analysis. Differentially expressed genes were validated using reverse transcription-polymerase chain reaction.
RESULTS
A total of 86 PD patients were selected from the Third Affifiliated People's Hospital of Fujian University of Traditional Chinese Medicine between January 2017 and December 2017. Finally, 72 patients completed the trial, including 35 in the treatment group and 37 in the control group. When compared with the control group after treatment, patients in the treatment group showed signifificant decreases in UPDRS sub-II score, PDQ-39 score, CM syndrome score, and Levodopa equivalent dose (P<0.05). During the treatment course, no signifificant changes were observed in safety indicators between the two groups (P>0.05). A possible mechanism of clinical effificacy was proposed that involved regulating cell metabolism-related processes and ribosome-related pathways. Treatment with CSGs had shown to affect relevant gene loci for PD, including AIDA, ANKRD36BP2, BCL2A1, BCL2L11, FTH1P2, GCH1, HPRT1, NFE2L2, RMRP, RPS7, TGFBR1, WIPF2, and COX7B.
CONCLUSIONS
CSGs combined with WM can be used to treat PD patients with CM syndrome of Shen essence defificiency with a good safety. The possible mechanism of action and relevant gene loci were proposed. (Registration No. ChiCTR-IOR-16008394).",2020,"During the treatment course, no signifificant changes were observed in safety indicators between the two groups (P>0.05).","['Eligible PD patients with syndrome of Shen essence defificiency', '72 patients completed the trial, including 35 in the treatment group and 37 in the control group', ""86 PD patients were selected from the Third Affifiliated People's Hospital of Fujian University of Traditional Chinese Medicine between January 2017 and December 2017"", ""Patients with Parkinson's Disease and Syndrome of Shen (Kidney) Essence Deficiency"", ""patients with Parkinson's disease (PD) and Chinese medicine (CM) syndrome of Shen (Kidney) essence deficiency""]","['Congrong Shujing Granules ', 'Congrong Shujing Granules ( , CSGs', 'control group by a random number table, and were treated with CSGs combined with Western medicine (WM), or placebo combined with WM, respectively']","['safety indicators', 'UPDRS sub-II score, PDQ-39 score, CM syndrome score, and Levodopa equivalent dose', ""Unifified Parkinson's Disease Rating Scale (UPDRS) score, the PD Question-39 (PDQ-39) score, CM Syndrome Scale score, and drug usage""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",,0.0598657,"During the treatment course, no signifificant changes were observed in safety indicators between the two groups (P>0.05).","[{'ForeName': 'Shi-Ya', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': ""Geriatrics Department, the Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.""}, {'ForeName': 'Shao-Jian', 'Initials': 'SJ', 'LastName': 'Xiao', 'Affiliation': ""Geriatrics Department, the Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.""}, {'ForeName': 'You-Ning', 'Initials': 'YN', 'LastName': 'Lin', 'Affiliation': ""Geriatrics Department, the Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.""}, {'ForeName': 'Xi-Yu', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': ""Geriatrics Department, the Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'College of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Sha-Sha', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'College of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.'}, {'ForeName': 'Lian-Hong', 'Initials': 'LH', 'LastName': 'Huang', 'Affiliation': 'College of Medical Technology and Engineering, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, 350001, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': ""Geriatrics Department, the Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China. caij1@163.com.""}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3080-0']
408,32291634,The videoscopic view may not be significantly superior to the directly sighted peroral view during Macintosh-style videolaryngoscopy: a randomized equivalence cadaver trial.,"PURPOSE
Videolaryngoscopy is widely believed to give a superior view to that obtained by direct laryngoscopy. Published literature suggests this benefit extends to both hyper-angulated and Macintosh-style videolaryngoscopes. Notwithstanding, our clinical experience shows that the videoscopic view with a Macintosh-style videolaryngoscope is often no different or only marginally better than the directly sighted peroral view.
METHODS
A human cadaver equivalence study was performed in which four experienced laryngoscopists obtained pre-assigned laryngeal views by direct sighting using the single-use Macintosh blades of the GlideScope® Spectrum™ (GS) DirectView Macintosh (DVM) and C-MAC®S videolaryngoscopes. Blinded to the laryngoscopist's view, two independent observers rated the videoscopic view presented on the proximal video monitor at the same time. Directly sighted and videoscopic views obtained by the laryngoscopist and video scorers were recorded on a visual analogue scale (VAS) for each device as the primary outcome measures and compared.
RESULTS
On the VAS, the C-MAC®S videoscopic view revealed only approximately 0.9% more (99% confidence interval [CI], -2.5% to 4.3%) of the laryngeal inlet than the directly sighted view. Using GS DVM, the videoscopic view revealed 6.7% (99% CI, 2.3% to 11.0%) more of the laryngeal inlet than the directly sighted view. Although results for the GS DVM achieved statistical significance, neither device gave a clinically significantly improved videoscopic view compared with the directly sighted peroral view.
CONCLUSION
This study failed to corroborate previously published findings of a clinically significantly improved videoscopic view compared with direct peroral sighting using Macintosh-style videolaryngoscopes. Further study of this class of device is warranted in human subjects.",2020,"Although results for the GS DVM achieved statistical significance, neither device gave a clinically significantly improved videoscopic view compared with the directly sighted peroral view.
","['human subjects', 'A human cadaver equivalence study was performed in which four experienced laryngoscopists obtained pre-assigned laryngeal views by direct sighting using the single-use Macintosh blades of the']",['GlideScope® Spectrum™ (GS) DirectView Macintosh (DVM) and C-MAC®S videolaryngoscopes'],['visual analogue scale (VAS'],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2948008', 'cui_str': 'Blade'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0353383,"Although results for the GS DVM achieved statistical significance, neither device gave a clinically significantly improved videoscopic view compared with the directly sighted peroral view.
","[{'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Malpas', 'Affiliation': 'Department of Adult and Emergency Anesthesia, Level 8, Auckland City Hospital, Auckland District Health Board, 2 Park Road, Grafton, Auckland, 1023, New Zealand. gmalpas@icloud.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kovacs', 'Affiliation': 'Department of Emergency Medicine, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Mackinnon', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Hung', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Phipps', 'Affiliation': ""Department of Anesthesia, Hawke's Bay Hospital, Camberley, Hastings, New Zealand.""}, {'ForeName': 'J Adam', 'Initials': 'JA', 'LastName': 'Law', 'Affiliation': 'Department of Anesthesia, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, NS, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01647-y']
409,32097932,The Effect of Drug-Eluting Stents on Target Lesion Revascularization in Native Coronary Arteries: Results from the NORSTENT Randomized Study.,"BACKGROUND
The NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) or bare-metal stent (BMS) with 5-year follow-up. No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularizations, which were reduced by DES. We report the occurrence of target lesion revascularization (TLR) in time and across demographic and clinical subgroups in patients with lesions in native coronary arteries (n = 8,782).
RESULTS
Clinically driven TLR was performed on 488 (5.6%) of the 8,782 patients during 5 years of follow-up. Male gender, older age, visible thrombus in the lesion, and larger stent diameter were associated with less TLR; multivessel disease and longer stents were associated with a higher risk of TLR. There was a substantial and highly significant reduction of the risk of any TLR after 5 years in the DES group (hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.36-0.52], p < 0.001). The effect of DES on TLR was limited in time to the first 2 years in the study with no evidence of a later rebound effect. The reduction in TLR after DES insertion was consistent across subgroups defined by gender, age, diabetes status, renal function, and lesion and stent characteristics. The number needed to treat with DES (vs. BMS) to prevent 1 TLR ranged from 4 to 110 across clinically relevant subgroups.
CONCLUSION
DES have a time-limited effect on the rate of TLR, but with a substantial and highly significant reduction in the first 2 years after the procedure. This effect was found to be consistent across all important clinical subgroups.",2020,No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up.,"['patients with lesions in native coronary arteries (n = 8,782', '9,013 patients to', 'Native Coronary Arteries']","['DES', 'percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) or bare-metal stent (BMS', 'Drug-Eluting Stents', 'target lesion revascularization (TLR']","['risk of any TLR', 'death from any cause and nonfatal spontaneous myocardial infarction', 'rate of TLR', 'reduction in TLR', 'repeat revascularizations, which were reduced by DES']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",9013.0,0.208977,No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up.,"[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Mølstad', 'Affiliation': 'Department of Cardiology, LHL Clinics Gardermoen, Jessheim, Norway, PerMorten.Molstad@lhl.no.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Nordrehaug', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Steigen', 'Affiliation': 'University Hospital of North Norway and UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Lasse Melvaer', 'Initials': 'LM', 'LastName': 'Giil', 'Affiliation': 'Department of Internal Medicine, Haraldsplass Deaconess Hospital, Bergen, Norway.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wilsgaard', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': ""Clinic of Cardiology, St. Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Kaare H', 'Initials': 'KH', 'LastName': 'Bønaa', 'Affiliation': ""Clinic of Cardiology, St. Olav's University Hospital, Trondheim, Norway.""}]",Cardiology,['10.1159/000506042']
410,31852462,The BE GONE trial study protocol: a randomized crossover dietary intervention of dry beans targeting the gut microbiome of overweight and obese patients with a history of colorectal polyps or cancer.,"BACKGROUND
Mouse and human studies support the promise of dry beans to improve metabolic health and to lower cancer risk. In overweight/obese patients with a history of colorectal polyps or cancer, the Beans to Enrich the Gut microbiome vs. Obesity's Negative Effects (BE GONE) trial will test whether and how an increase in the consumption of pre-cooked, canned dry beans within the context of usual diet and lifestyle can enhance the gut landscape to improve metabolic health and reduce cancer risk.
METHODS/DESIGN
This randomized crossover trial is designed to characterize changes in (1) host markers spanning lipid metabolism, inflammation, and obesity-related cancer risk; (2) compositional and functional profiles of the fecal microbiome; and (3) host and microbial metabolites. With each subject serving as their own control, the trial will compare the participant's usual diet with (intervention) and without (control) dry beans. Canned, pre-cooked dry beans are provided to participants and the usual diet continually assessed and monitored. Following a 4-week run-in and equilibration period, each participant provides a total of 5 fasting blood and 6 stool samples over a total period of 16 weeks. The intervention consists of a 2-week ramp-up of dry bean intake to 1 cup/d, which is then continued for an additional 6 weeks. Intra- and inter-individual outcomes are assessed across each crossover period with consideration of the joint or modifying effects of the usual diet and baseline microbiome.
DISCUSSION
The BE GONE trial is evaluating a scalable dietary prevention strategy targeting the gut microbiome of high-risk patients to mitigate the metabolic and inflammatory effects of adiposity that influence colorectal cancer risk, recurrence, and survival. The overarching scientific goal is to further elucidate interactions between diet, the gut microbiome, and host metabolism. Improved understanding of the diet-microbiota interplay and effective means to target these relationships will be key to the future of clinical and public health approaches to cancer and other major diet- and obesity-related diseases.
TRIAL REGISTRATION
This protocol is registered with the U.S. National Institutes of Health trial registry, ClinicalTrials.gov, under the identifier NCT02843425. First posted July 25, 2016; last verified January 25, 2019.",2019,"trial will test whether and how an increase in the consumption of pre-cooked, canned dry beans within the context of usual diet and lifestyle can enhance the gut landscape to improve metabolic health and reduce cancer risk.
","['overweight and obese patients with a history of colorectal polyps or cancer', ""overweight/obese patients with a history of colorectal polyps or cancer, the Beans to Enrich the Gut microbiome vs. Obesity's Negative Effects (BE GONE""]","['dry beans targeting', 'usual diet with (intervention) and without (control) dry beans']",['metabolic health'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]","[{'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0348368,"trial will test whether and how an increase in the consumption of pre-cooked, canned dry beans within the context of usual diet and lifestyle can enhance the gut landscape to improve metabolic health and reduce cancer risk.
","[{'ForeName': 'Xiaotao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1340, Houston, TX, TX 77030, USA.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Browman', 'Affiliation': 'Department of Epidemiology, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1340, Houston, TX, TX 77030, USA.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Siu', 'Affiliation': 'Department of Epidemiology, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1340, Houston, TX, TX 77030, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Basen-Engquist', 'Affiliation': 'Department of Behavioral Science, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Samir M', 'Initials': 'SM', 'LastName': 'Hanash', 'Affiliation': 'Department of Clinical Cancer Prevention, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Hoffman', 'Affiliation': 'Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Pablo C', 'Initials': 'PC', 'LastName': 'Okhuysen', 'Affiliation': 'Department of Infectious Diseases, Infection Control, and Employee Health, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Scheet', 'Affiliation': 'Department of Epidemiology, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1340, Houston, TX, TX 77030, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Petrosino', 'Affiliation': 'Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kopetz', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Daniel', 'Affiliation': 'Department of Epidemiology, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1340, Houston, TX, TX 77030, USA. CDaniel@mdanderson.org.'}]",BMC cancer,['10.1186/s12885-019-6400-z']
411,30496493,"Differential effects of endurance, interval, and resistance training on telomerase activity and telomere length in a randomized, controlled study.","Aims
It is unknown whether different training modalities exert differential cellular effects. Telomeres and telomere-associated proteins play a major role in cellular aging with implications for global health. This prospective training study examines the effects of endurance training, interval training (IT), and resistance training (RT) on telomerase activity and telomere length (TL).
Methods and results
One hundred and twenty-four healthy previously inactive individuals completed the 6 months study. Participants were randomized to three different interventions or the control condition (no change in lifestyle): aerobic endurance training (AET, continuous running), high-intensive IT (4 × 4 method), or RT (circle training on 8 devices), each intervention consisting of three 45 min training sessions per week. Maximum oxygen uptake (VO2max) was increased by all three training modalities. Telomerase activity in blood mononuclear cells was up-regulated by two- to three-fold in both endurance exercise groups (AET, IT), but not with RT. In parallel, lymphocyte, granulocyte, and leucocyte TL increased in the endurance-trained groups but not in the RT group. Magnet-activated cell sorting with telomerase repeat-ampliflication protocol (MACS-TRAP) assays revealed that a single bout of endurance training-but not RT-acutely increased telomerase activity in CD14+ and in CD34+ leucocytes.
Conclusion
This randomized controlled trial shows that endurance training, IT, and RT protocols induce specific cellular pathways in circulating leucocytes. Endurance training and IT, but not RT, increased telomerase activity and TL which are important for cellular senescence, regenerative capacity, and thus, healthy aging.",2019,"Endurance training and IT, but not RT, increased telomerase activity and TL which are important for cellular senescence, regenerative capacity, and thus, healthy aging.",['One hundred and twenty-four healthy previously inactive individuals completed the 6\u2009months study'],"['endurance training, IT, and RT protocols', 'endurance, interval, and resistance training', 'control condition (no change in lifestyle): aerobic endurance training (AET, continuous running), high-intensive IT (4\u2009×\u20094 method), or RT (circle training', 'endurance training, interval training (IT), and resistance training (RT']","['lymphocyte, granulocyte, and leucocyte TL', 'Telomerase activity in blood mononuclear cells', 'telomerase activity and TL', 'telomerase activity and telomere length (TL', 'telomerase activity and telomere length', 'Maximum oxygen uptake (VO2max']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0629582', 'cui_str': 'AETS'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake (observable entity)'}]",124.0,0.0185942,"Endurance training and IT, but not RT, increased telomerase activity and TL which are important for cellular senescence, regenerative capacity, and thus, healthy aging.","[{'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Werner', 'Affiliation': 'Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universität und Universitätsklinikum des Saarlandes, Geb. 41.1/IMED, Homburg/Saar, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hecksteden', 'Affiliation': 'Institut für Sport und Präventivmedizin, Universität des Saarlandes, Campus, B8 2, Saarbrücken, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Morsch', 'Affiliation': 'Deutsche Hochschule für Prävention und Gesundheitsmanagement, Hermann-Neuberger-Sportschule 3, Saarbrücken, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Zundler', 'Affiliation': 'Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universität und Universitätsklinikum des Saarlandes, Geb. 41.1/IMED, Homburg/Saar, Germany.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wegmann', 'Affiliation': 'Institut für Sport und Präventivmedizin, Universität des Saarlandes, Campus, B8 2, Saarbrücken, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kratzsch', 'Affiliation': 'Institut für Labormedizin, Klinische Chemie und Molekulare Diagnostik, Universitätsklinikum, Liebigstr. 20, Leipzig, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Thiery', 'Affiliation': 'Institut für Labormedizin, Klinische Chemie und Molekulare Diagnostik, Universitätsklinikum, Liebigstr. 20, Leipzig, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hohl', 'Affiliation': 'Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universität und Universitätsklinikum des Saarlandes, Geb. 41.1/IMED, Homburg/Saar, Germany.'}, {'ForeName': 'Jörg Thomas', 'Initials': 'JT', 'LastName': 'Bittenbring', 'Affiliation': 'Klinik für Innere Medizin I, Onkologie, Hämatologie, Klinische Immunologie und Rheumatologie, Universitätsklinikum des Saarlandes, Geb. 41.1/IMED, Homburg/Saar, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Neumann', 'Affiliation': 'Klinik für Innere Medizin I, Onkologie, Hämatologie, Klinische Immunologie und Rheumatologie, Universitätsklinikum des Saarlandes, Geb. 41.1/IMED, Homburg/Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universität und Universitätsklinikum des Saarlandes, Geb. 41.1/IMED, Homburg/Saar, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Institut für Sport und Präventivmedizin, Universität des Saarlandes, Campus, B8 2, Saarbrücken, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, Leipzig, Germany.'}]",European heart journal,['10.1093/eurheartj/ehy585']
412,31034622,"Genes, Roommates, and Residence Halls: A Multidimensional Study of the Role of Peer Drinking on College Students' Alcohol Use.","BACKGROUND
Peer drinking is one of the most robust predictors of college students' alcohol use and can moderate students' genetic risk for alcohol use. Peer effect research generally suffers from 2 problems: selection into peer groups and relying more on perceptions of peer alcohol use than peers' self-report. The goal of the present study was to overcome those limitations by capitalizing on a genetically informed sample of randomly assigned college roommates to examine multiple dimensions of peer influence and the interplay between peer effects and genetic predisposition on alcohol use, in the form of polygenic scores.
METHODS
We used a subsample (n = 755) of participants from a university-wide, longitudinal study at a large, diverse, urban university. Participants reported their own alcohol use during fall and spring and their perceptions of college peers' alcohol use in spring. We matched individuals into their rooms and residence halls to create a composite score of peer-reported alcohol use for each of those levels. We examined multiple dimensions of peer influence and whether peer influence moderated genetic predisposition to predict college students' alcohol use using multilevel models to account for clustering at the room and residence hall level.
RESULTS
We found that polygenic scores (β = 0.12), perceptions of peer drinking (β = 0.37), and roommates' self-reported drinking (β = 0.10) predicted alcohol use (all ps < 0.001), while average alcohol use across residence hall did not (β = -0.01, p = 0.86). We found no evidence for interactions between peer influence and genome-wide polygenic scores for alcohol use.
CONCLUSIONS
Our findings underscore the importance of genetic predisposition on individual alcohol use and support the potentially causal nature of the association between peer influence and alcohol use.",2019,"We found no evidence for interactions between peer influence and genome-wide polygenic scores for alcohol use.
","['subsample (n\xa0=\xa0755) of participants from a university-wide, longitudinal study at a large, diverse, urban university', ""College Students' Alcohol Use""]",[],"['perceptions of peer drinking', 'Genes, Roommates, and Residence Halls']","[{'cui': 'C4517872', 'cui_str': 'Seven hundred and fifty-five'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C2356088', 'cui_str': 'Halls'}]",,0.0149602,"We found no evidence for interactions between peer influence and genome-wide polygenic scores for alcohol use.
","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Salvatore', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Fazil', 'Initials': 'F', 'LastName': 'Aliev', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Neale', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barr', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Dick', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14037']
413,32159882,Safety and efficacy of first-line dacomitinib in Japanese patients with advanced non-small cell lung cancer.,"In a subgroup of Japanese patients in the ARCHER 1050 randomized phase 3 trial, we evaluated the efficacy and safety and determined the effects of dose modifications on adverse events (AE) and therapy management of first-line oral dacomitinib 45 mg compared with oral gefitinib 250 mg, each once daily in 28-d cycles, in patients with EGFR-activating mutation-positive (EGFR-positive; exon 19 deletion or exon 21 L858R substitution mutations) advanced non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS; RECIST, version 1.1, by blinded independent review). In 81 Japanese patients (40 dacomitinib, 41 gefitinib), PFS was longer with dacomitinib compared with gefitinib (hazard ratio [HR], 0.544 [95% confidence interval {CI}, 0.307-0.961]; 2-sided P = .0327; median 18.2 for dacomitinib [95% CI, 11.0-31.3] mo, 9.3 [95% CI, 7.4-14.7] mo for gefitinib). The most common Grade 3 AEs were dermatitis acneiform with dacomitinib (27.5%) and increased alanine aminotransferase with gefitinib (12.2%). A higher proportion of patients receiving dacomitinib (85.0%) compared with gefitinib (24.4%) had AEs leading to dose reduction. Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction. Our results confirmed the efficacy and safety of first-line dacomitinib in Japanese patients with EGFR-positive advanced NSCLC.",2020,"Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction.","['81 Japanese patients', 'Japanese patients with EGFR-positive advanced NSCLC', 'Japanese patients with advanced non-small cell lung cancer']","['first-line dacomitinib', 'oral gefitinib', 'EGFR-activating mutation-positive (EGFR-positive; exon 19 deletion or exon 21 L858R substitution mutations) advanced non-small cell lung cancer (NSCLC']","['Safety and efficacy', 'progression-free survival', 'efficacy and safety', 'alanine aminotransferase', 'Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia', 'dermatitis acneiform with dacomitinib']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2987430'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0234894', 'cui_str': 'Dermatitis acneiform'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C2987430'}]",81.0,0.130685,"Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Niho', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Kaneda', 'Affiliation': 'Department of Clinical Oncology, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wilner', 'Affiliation': 'Pfizer Oncology, La Jolla, CA, USA.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Isozaki', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Wada', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Fumito', 'Initials': 'F', 'LastName': 'Tsuji', 'Affiliation': 'SFJ Pharma Japan, Osaka, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}]",Cancer science,['10.1111/cas.14384']
414,31517677,Guiding Opioid Administration by 3 Different Analgesia Nociception Monitoring Indices During General Anesthesia Alters Intraoperative Sufentanil Consumption and Stress Hormone Release: A Randomized Controlled Pilot Study.,"BACKGROUND
This pilot study investigated the effect of sufentanil titration by 3 different analgesia monitoring devices or clinical signs during general anesthesia.
METHODS
Forty-eight patients undergoing radical retropubic prostatectomy with sevoflurane/sufentanil anesthesia were randomly assigned into 4 groups and received sufentanil guided either by 1 of 3 analgesia monitoring devices (Surgical Pleth Index [SPI], Pupillary Pain Index [PPI], Nociception Level [NoL]) or by clinical judgment (control). The primary end point was intraoperative sufentanil consumption. Adrenocorticotropic hormone (ACTH) and cortisol were measured at 4 time points during the day of surgery. Data were analyzed by Kruskal-Wallis and Mann-Whitney U tests and by mixed model and area under the curve (AUC) analyses for group comparisons and time effects of stress hormones.
RESULTS
The total amount of sufentanil administration (μg·kg·minute·10) differed between the groups (median [quartiles]: control = 5.6 [4.4-6.4], SPI = 7.2 [4.8-8.4], PPI = 2.0 [1.8-2.9], NoL = 3.8 [3.3-5.1]; PPI versus SPI, -5.1 [-6.6 to -1.3], P < .001; NoL versus SPI, -3.0 [-5.2 to 0.2], P = .024; control versus SPI, -1.6 [-3.7 to 1.7], P = .128; NoL versus PPI, 1.7 [0.6-3.4], P < .001; control versus PPI, 3.4 [2.0-4.6], P < .001; control versus NoL, 1.6 [-0.2 to 3.3], P = .017) (Hodges-Lehmann estimator [99% confidence interval {CI}], P values). The AUC analysis indicated differences among groups in cumulative ACTH levels (ng·liter·minute, natural logarithm (ln)-transformed data) of NoL versus PPI (-1.079 [-1.950 to -0.208], P = .001) and PPI versus SPI (1.192 [0.317-2.068], P= .001), as well as differences in cortisol levels (µg·liter·minute) for PPI versus SPI (46,710 [21,145-72,274], P < .001), NoL versus SPI (27,645 [3163-52,126], P = .003), and control versus SPI (31,824 [6974-56,675], P = .001) (differences in means [99% CI], P value). Secondary end points (postoperative recovery, pain level, and analgesia medication) showed no differences.
CONCLUSIONS
The type of analgesia nociception monitoring affected the total amount of sufentanil administered. Lower sufentanil doses in the PPI group were associated with an increased endocrine stress response. Titration by SPI caused no opioid reduction compared to the control but was associated with a reduced endocrine stress response.",2020,"control versus NoL, 1.6 [-0.2 to 3.3], P = .017)",['Forty-eight patients undergoing'],"['radical retropubic prostatectomy with sevoflurane/sufentanil anesthesia', 'sufentanil guided either by 1 of 3 analgesia monitoring devices (Surgical Pleth Index [SPI], Pupillary Pain Index [PPI], Nociception Level [NoL]) or by clinical judgment (control', 'sufentanil titration']","['endocrine stress response', 'intraoperative sufentanil consumption', 'cortisol levels (µg·liter·minute', 'Adrenocorticotropic hormone (ACTH) and cortisol', 'cumulative ACTH levels (ng·liter·minute, natural logarithm (ln)-transformed data) of NoL versus PPI', 'points (postoperative recovery, pain level, and analgesia medication', 'PPI', 'Intraoperative Sufentanil Consumption and Stress Hormone Release', 'total amount of sufentanil administration (μg·kg·minute·10']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194825', 'cui_str': 'Radical retropubic prostatectomy (procedure)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",48.0,0.142204,"control versus NoL, 1.6 [-0.2 to 3.3], P = .017)","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Funcke', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans O', 'Initials': 'HO', 'LastName': 'Pinnschmidt', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wesseler', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Brinkmann', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Beyer', 'Affiliation': 'Martini-Klinik, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Virginija', 'Initials': 'V', 'LastName': 'Jazbutyte', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph R', 'Initials': 'CR', 'LastName': 'Behem', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Trepte', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Nitzschke', 'Affiliation': 'From the Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004388']
415,32291095,"A randomized half-body, double blind, controlled trial on the effects of a pH-modified moisturizer vs. standard moisturizer in mild to moderate atopic dermatitis.","BACKGROUND
Higher skin pH in atopic dermatitis contributes to impaired epidermal barrier. A moisturizer compatible with physiological pH could improve atopic dermatitis.
OBJECTIVE
To determine the effect of a physiologically compatible pH moisturizer in atopic dermatitis.
METHODS
A randomized half body, double blind, controlled trial involving patients with stable atopic dermatitis was performed. pH-modified moisturizer and standard moisturizer were applied to half body for 6 weeks.
RESULTS
A total of 6 (16.7%) males and 30 (83.3%) females participated. Skin pH reductions from week 0, week 2 and 6 were significant at the forearms (5.315 [0.98] to 4.85 [0.54] to 5.04 [0.78], p=0.02) and abdomen (5.25 [1.01], 4.82 [0.64], 5.01 [0.59], p=0.00) but not at the shins (5.01 [0.80], 4.76 [0.49], 4.85 [0.79], p=0.09) with pH-modified moisturizer. Transepidermal water loss (TEWL) at the forearms decreased (4.60 [2.55] to 3.70 [3.10] to 3.00 [3.55], p=0.00), abdomen (3.90 [2.90] to 2.40 [3.45] to 2.70 [2.25], p=0.046). SCORAD improved from 14.1±12.75 to 10.5±13.25 to 7±12.25, p=0.00. In standard moisturizer group, pH reductions were significant at the forearms (5.29 [0.94] to 4.84 [0.55] to 5.02 [0.70], p=0.00) and abdomen (5.25 [1.09], 4.91 [0.63], 5.12 [0.66], p=0.00). TEWL at the forearm were (4.80 [2.95], 4.10 [2.15], 4.60 [3.40], p=0.67), shins (3.80 [1.40], 3.50 [2.35], 4.00 [2.50], p=0.91) and abdomen (3.70 [2.45], 4.10 [3.60], 3.40 [2.95], p=0.80). SCORAD improved from 14.2±9.1 to 10.9±10.65 to 10.5±11, p=0.00. Reduction in pH was observed with both moisturizers while TEWL significantly improved with pH-modified moisturizer. pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.
STUDY LIMITATION
Skin hydration was not evaluated.
CONCLUSION
Moisturization is beneficial for atopic dermatitis; use of physiologically compatible pH moisturizer is promising.",2020,"pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.
","['patients with stable atopic dermatitis', 'atopic dermatitis', 'mild to moderate atopic dermatitis', 'A total of 6 (16.7%) males and 30 (83.3%) females participated']","['Moisturization', 'pH-modified moisturizer vs. standard moisturizer', 'pH-modified moisturizer and standard moisturizer']","['greater pH, TEWL and SCORAD improvements', 'Reduction in pH', 'pH reductions', 'SCORAD', 'atopic dermatitis', 'Transepidermal water loss (TEWL', 'Skin pH reductions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0232445', 'cui_str': 'Acid mantle'}]",,0.11098,"pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.
","[{'ForeName': 'Siew Wen', 'Initials': 'SW', 'LastName': 'Goh', 'Affiliation': 'Dermatology Unit, Medical Department, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia; Dermatology Unit, Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Adawiyah', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia; Dermatology Unit, Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia. Electronic address: adda_jamil@yahoo.com.'}, {'ForeName': 'Nazarudin', 'Initials': 'N', 'LastName': 'Safian', 'Affiliation': 'Department of Community Health, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Norazirah', 'Initials': 'N', 'LastName': 'Md Nor', 'Affiliation': 'Dermatology Unit, Medical Department, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia; Dermatology Unit, Department of Medicine, University Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Norliza', 'Initials': 'N', 'LastName': 'Muhammad', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nur Liyana', 'Initials': 'NL', 'LastName': 'Saharudin', 'Affiliation': 'Department of Pharmacy, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}]",Anais brasileiros de dermatologia,['10.1016/j.abd.2019.11.007']
416,32108686,Prophylactic Intrathecal Morphine and Prevention of Post-Dural Puncture Headache: A Randomized Double-blind Trial.,"BACKGROUND
Prophylactic epidural morphine administration after unintentional dural puncture with a large-bore needle has been shown to decrease the incidence of post-dural puncture headache. The authors hypothesized that prophylactic administration of intrathecal morphine would decrease the incidence of post-dural puncture headache and/or need for epidural blood patch after unintentional dural puncture.
METHODS
Parturients with an intrathecal catheter in situ after unintentional dural puncture with a 17-g Tuohy needle during intended epidural catheter placement for labor analgesia were enrolled in this randomized, double-blind trial. After delivery, subjects were randomized to receive intrathecal morphine 150 µg or normal saline. The primary outcome was the incidence of post-dural puncture headache. Secondary outcomes included onset, duration, and severity of post-dural puncture headache, the presence of cranial nerve symptoms and the type of treatment the patient received.
RESULTS
Sixty-one women were included in the study. The incidence of post-dural puncture headache was 21 of 27 (78%) in the intrathecal morphine group and 27 of 34 (79%) in the intrathecal saline group (difference, -1%; 95% CI, -25% to 24%). There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms. Epidural blood patch was administered to 10 of 27 (37%) of subjects in the intrathecal morphine and 11 of 21 (52%) of the intrathecal saline group (difference 15%; 95% CI, -18% to 48%).
CONCLUSIONS
The present findings suggest that a single prophylactic intrathecal morphine dose of 150 µg administered shortly after delivery does not decrease the incidence or severity of post-dural puncture headache after unintentional dural puncture. This study does not support the clinical usefulness of prophylactic intrathecal morphine after an unintentional dural puncture.",2020,"There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms.","['unintentional dural puncture', 'Sixty-one women were included in the study', 'Post-Dural Puncture Headache', 'Parturients with an intrathecal catheter in situ after unintentional dural puncture with a 17-g Tuohy needle during intended epidural catheter placement for labor analgesia']","['prophylactic intrathecal morphine', 'intrathecal morphine', 'intrathecal saline', 'Epidural morphine', 'intrathecal morphine 150 µg or normal saline', 'Prophylactic Intrathecal Morphine']","['onset, duration, or severity of headache, or presence of cranial nerve symptoms', 'incidence or severity of post-dural puncture headache', 'onset, duration, and severity of post-dural puncture headache, the presence of cranial nerve symptoms and the type of treatment the patient received', 'Epidural blood patch', 'incidence of post-dural puncture headache']","[{'cui': 'C0919916', 'cui_str': 'Unintentional dural puncture'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}, {'cui': 'C2584606', 'cui_str': 'Intrathecal catheter'}, {'cui': 'C0444498', 'cui_str': 'In situ (qualifier value)'}, {'cui': 'C0050288', 'cui_str': 'A 17'}, {'cui': 'C0184186', 'cui_str': 'Tuohy epidural needle'}, {'cui': 'C3665866', 'cui_str': 'Epidural catheter placement'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0010268', 'cui_str': 'Cranial Nerves'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162649', 'cui_str': 'Patchs, Epidural Blood'}]",61.0,0.677125,"There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms.","[{'ForeName': 'Feyce M', 'Initials': 'FM', 'LastName': 'Peralta', 'Affiliation': 'From the Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (F.M.P., N.H., P.T., M.J.J.) Department of Anesthesia, University of Iowa Carver College of Medicine, Iowa City, Iowa (C.A.W.) Department of Anesthesiology, Rush University Medical Center, Chicago, Illinois (R.J.M.).'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Toledo', 'Affiliation': ''}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'McCarthy', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003206']
417,31989162,Frontal alpha asymmetry in alcohol-related intimate partner violence.,"Electroencephalographic (EEG) frontal alpha asymmetry (FAA) has been associated with differences in the experience and expression of emotion, motivation and anger in normal and clinical populations. The current study is the first to investigate FAA in alcohol-related intimate partner violence. EEG was recorded from 23 distressed violent (DV) and 15 distressed nonviolent (DNV) partners during a placebo-controlled alcohol administration and emotion-regulation study. The State-Trait Anger Expression Inventory 2 was used to evaluate anger experiences and was collected from both participants and their partners. During baseline, acute alcohol intoxication DV partners had significantly greater right FAA, whereas DNV partners showed greater left FAA. Both partner types demonstrated significantly greater right FAA during the placebo beverage condition of the emotion-regulation task when viewing evocative partner displays of contempt, belligerence, criticism, defensiveness and stonewalling, but greater left FAA during acute alcohol intoxication. Although no group differences were found in the emotion-regulation task, partner self-reported anger experiences accounted for 67% of the variance in the FAA of DV participants when intoxicated and viewing evocative stimuli, suggesting dyadic processes are important in understanding alcohol-related IPV. These findings suggest that FAA could index the affective and motivational determinants through which alcohol is related to IPV.",2019,During baseline acute alcohol intoxication DV partners had significantly greater right FAA whereas DNV partners showed greater left FAA.,['Alcohol-Related Intimate Partner Violence'],"['placebo', 'Electroencephalographic (EEG) frontal alpha asymmetry (FAA', 'FAA']","['left FAA', 'right FAA', 'emotion-regulation task, partner self-reported anger experiences']","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}]",,0.0141401,During baseline acute alcohol intoxication DV partners had significantly greater right FAA whereas DNV partners showed greater left FAA.,"[{'ForeName': 'Brandi C', 'Initials': 'BC', 'LastName': 'Fink', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Breannan C', 'Initials': 'BC', 'LastName': 'Howell', 'Affiliation': 'Department of Psychology, The University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Salway', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cavanagh', 'Affiliation': 'Department of Psychology, The University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Derek A', 'Initials': 'DA', 'LastName': 'Hamilton', 'Affiliation': 'Department of Psychology, The University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Claus', 'Affiliation': 'Mind Research Network, Albuquerque, NM, USA.'}, {'ForeName': 'Madeline E', 'Initials': 'ME', 'LastName': 'Frost', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of New Mexico, Albuquerque, NM 87131, USA.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsz101']
418,31103018,Neural and behavioral effects of oxytocin administration during theory of mind in schizophrenia and controls: a randomized control trial.,"Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical importance, current medications do not improve these deficits. The current study investigated the hypothesis that oxytocin, a neuropeptide implicated in social behavior, would normalize neural abnormalities in schizophrenia during ToM, and that this normalization would correlate improvement in ToM behavior. In this cross-over, double-blind, and placebo-controlled functional magnetic resonance imaging study, a single dose of 40 IU of oxytocin was administered via nasal spray to male individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n = 23) and healthy controls (n = 25). Participants completed two ToM tasks in the scanner, the False Belief and Person Description tasks. During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls. Oxytocin, relative to placebo, significantly increased accuracy and rTPJ activation for ToM but not control stories in schizophrenia. Furthermore, a significant positive correlation was found between oxytocin induced increases in rTPJ activity and accuracy, indicating that oxytocin improved rTPJ activity in schizophrenia predicted behavioral improvement. Oxytocin also significantly improved connectivity between rTPJ and mPFC in schizophrenia. These findings suggest that rTPJ activity during ToM might be a potential neural target for the treatment of social cognitive deficits in schizophrenia.",2019,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","['schizophrenia and controls', 'male\xa0individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n\u2009=\u200923) and healthy controls (n\u2009=\u200925']","['Oxytocin', 'placebo', 'oxytocin']","['rTPJ activity and accuracy', 'accuracy and rTPJ activation', 'Social cognitive impairments, including theory of mind (ToM', 'connectivity', 'reduced accuracy, hypo-activity', 'rTPJ activity']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",,0.12082,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","[{'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'University of California, San Francisco, CA, USA. josh.woolley@ucsf.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0417-5']
419,31323685,High-intensity interval training modulates retinal microvascular phenotype and DNA methylation of p66Shc gene: a randomized controlled trial (EXAMIN AGE).,"AIMS
Impairments of retinal vessel diameter are associated with major adverse cardiovascular (CV) events. Promoter DNA methylation is a repressor of the mitochondrial adaptor p66Shc gene transcription, a key driver of ageing-induced reactive oxygen species. The study aimed to investigate whether high-intensity interval training (HIIT) affects retinal microvascular phenotype as well as p66Shc expression and oxidative stress in ageing subjects with increased CV risk from the EXAMIN AGE cohort.
METHODS AND RESULTS
Eighty-four sedentary subjects (mean age 59.4 ± 7.0 years) with ≥2 CV risk factors were randomized into either a 12-week HIIT or standard physical activity recommendations. Retinal arteriolar and venular diameters were measured by use of a retinal vessel analyser. As a marker of oxidative stress plasma 3-nitrotyrosine (3-NT) level was determined by ELISA. Gene expression of p66Shc and DNA methylation were assessed in mononuclear cells by RT-qPCR and methylated-DNA capture (MethylMiner Enrichment Kit) coupled with qPCR, respectively. High-intensity interval training reduced body mass index, fat mass, low-density lipoprotein and increased muscle mass, as well as maximal oxygen uptake (VO2max). Moreover, HIIT restored microvascular phenotype by inducing retinal arteriolar widening (pre: 175 ± 14 µm vs. post: 181 ± 13 µm, P = 0.001) and venular narrowing (pre: 222 ± 14 µm vs. post: 220 ± 14 µm, P = 0.007). After HIIT, restoration of p66Shc promoter methylation (P = 0.034) reduced p66Shc gene expression (P = 0.037) and, in turn, blunted 3-NT plasma levels (P = 0.002).
CONCLUSION
High-intensity interval training rescues microvascular dysfunction in ageing subjects at increased CV risk. Exercise-induced reprogramming of DNA methylation of p66Shc gene may represent a putative mechanistic link whereby exercise protects against age-related oxidative stress.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov: NCT02796976 (https://clinicaltrials.gov/ct2/show/NCT02796976).",2020,"High-intensity interval training reduced body mass index, fat mass, low-density lipoprotein and increased muscle mass, as well as maximal oxygen uptake (VO2max).","['ageing subjects with increased CV risk from the EXAMIN AGE cohort', 'Eighty-four sedentary subjects (mean age 59.4\u2009±\u20097.0\u2009years) with ≥2 CV risk factors', 'p66Shc gene']","['high-intensity interval training (HIIT', 'High-intensity interval training', 'HIIT or standard physical activity recommendations']","['oxidative stress plasma 3-nitrotyrosine (3-NT) level', 'blunted 3-NT plasma levels', 'p66Shc expression and oxidative stress', 'venular narrowing', 'restoration of p66Shc promoter methylation', 'body mass index, fat mass, low-density lipoprotein and increased muscle mass, as well as maximal oxygen uptake (VO2max', 'Retinal arteriolar and venular diameters', 'retinal arteriolar widening', 'p66Shc gene expression', 'Gene expression of p66Shc and DNA methylation']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}]",84.0,0.175054,"High-intensity interval training reduced body mass index, fat mass, low-density lipoprotein and increased muscle mass, as well as maximal oxygen uptake (VO2max).","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Streese', 'Affiliation': 'Department of Sport, Exercise and Health, Medical Faculty, University of Basel, Birsstrasse 320 B, 4052 Basel, Switzerland.'}, {'ForeName': 'Abdul Waheed', 'Initials': 'AW', 'LastName': 'Khan', 'Affiliation': 'Cardiology Unit, Department of Medicine Solna, Karolinska Institute, Karolinska Universitetssjukhuset, Solna S1:02 171 76 Stockholm, Sweden.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Deiseroth', 'Affiliation': 'Department of Sport, Exercise and Health, Medical Faculty, University of Basel, Birsstrasse 320 B, 4052 Basel, Switzerland.'}, {'ForeName': 'Shafaat', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Cardiology Unit, Department of Medicine Solna, Karolinska Institute, Karolinska Universitetssjukhuset, Solna S1:02 171 76 Stockholm, Sweden.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Suades', 'Affiliation': 'Cardiology Unit, Department of Medicine Solna, Karolinska Institute, Karolinska Universitetssjukhuset, Solna S1:02 171 76 Stockholm, Sweden.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Tiaden', 'Affiliation': 'Department of Rheumatology, University Hospital, University of Basel, Spitalstrasse 21/ Petersgraben 4, 4031 Basel, Switzerland.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Kyburz', 'Affiliation': 'Department of Rheumatology, University Hospital, University of Basel, Spitalstrasse 21/ Petersgraben 4, 4031 Basel, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Cardiology Unit, Department of Medicine Solna, Karolinska Institute, Karolinska Universitetssjukhuset, Solna S1:02 171 76 Stockholm, Sweden.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Department of Sport, Exercise and Health, Medical Faculty, University of Basel, Birsstrasse 320 B, 4052 Basel, Switzerland.'}]",European heart journal,['10.1093/eurheartj/ehz196']
420,32167976,Effects of Inhaled Iloprost on Lung Mechanics and Myocardial Function During One-Lung Ventilation in Chronic Obstructive Pulmonary Disease Patients Combined With Poor Lung Oxygenation.,"BACKGROUND
The ventilation/perfusion mismatch in chronic obstructive pulmonary disease (COPD) patients can exacerbate cardiac function as well as pulmonary oxygenation. We hypothesized that inhaled iloprost can ameliorate pulmonary oxygenation with lung mechanics and myocardial function during one-lung ventilation (OLV) in COPD patients combined with poor lung oxygenation.
METHODS
A total of 40 patients with moderate to severe COPD, who exhibited the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FIO2) <150 mm Hg 30 minutes after initiating OLV, were enrolled in this study. Patients were randomly allocated into either ILO group (n = 20) or Control group (n = 20), in which iloprost (20 μg) and saline were inhaled, respectively. The PaO2/FIO2 ratio, dead space, dynamic compliance, and tissue Doppler imaging with myocardial performance index (MPI) were assessed 30 minutes after initiating OLV (pre-Tx) and 30 minutes after completion of drug inhalation (post-Tx). Repeated variables were analyzed using a linear mixed-model between the groups.
RESULTS
At pre-Tx, no differences were observed in measured parameters between the groups. At post-Tx, PaO2/FIO2 ratio (P < .001) and dynamic compliance (P = .023) were significantly higher and dead space ventilation was significantly lower (P = .001) in iloprost group (ILO group) compared to Control group. Left (P = .003) and right ventricular MPIs (P < .001) significantly decreased in ILO group compared to Control group.
CONCLUSIONS
Inhaled iloprost improved pulmonary oxygenation, lung mechanics, and cardiac function simultaneously during OLV in COPD patients with poor lung oxygenation.",2020,"Left (P = .003) and right ventricular MPIs (P < .001) significantly decreased in ILO group compared to Control group.
","['COPD patients combined with poor lung oxygenation', 'COPD patients with poor lung oxygenation', 'chronic obstructive pulmonary disease (COPD) patients', '40 patients with moderate to severe COPD, who exhibited the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FIO2) <150 mm', 'Chronic Obstructive Pulmonary Disease Patients Combined With Poor Lung Oxygenation', 'Hg 30 minutes after initiating OLV']","['ILO', 'iloprost', 'Inhaled Iloprost', 'inhaled iloprost', 'Inhaled iloprost', 'iloprost (20 μg) and saline']","['Lung Mechanics and Myocardial Function', 'right ventricular MPIs', 'pulmonary oxygenation, lung mechanics, and cardiac function simultaneously', 'pulmonary oxygenation with lung mechanics and myocardial function', 'PaO2/FIO2 ratio', 'PaO2/FIO2 ratio, dead space, dynamic compliance, and tissue Doppler imaging with myocardial performance index (MPI', 'dead space ventilation', 'dynamic compliance']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}]","[{'cui': 'C0079594', 'cui_str': 'Iloprost'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance (observable entity)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]",40.0,0.0179437,"Left (P = .003) and right ventricular MPIs (P < .001) significantly decreased in ILO group compared to Control group.
","[{'ForeName': 'Namo', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Su Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei Sarang Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Youngeun', 'Initials': 'Y', 'LastName': 'Joe', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Taelim', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heesoo', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Jun', 'Initials': 'YJ', 'LastName': 'Oh', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004733']
421,30959514,Neurophysiological signature of gamma-hydroxybutyrate augmented sleep in male healthy volunteers may reflect biomimetic sleep enhancement: a randomized controlled trial.,"Gamma-hydroxybutyrate (GHB) is an endogenous GHB/GABA B receptor agonist, which has demonstrated potency in consolidating sleep and reducing excessive daytime sleepiness in narcolepsy. Little is known whether GHB's efficacy reflects the promotion of physiological sleep mechanisms and no study has investigated its sleep consolidating effects under low sleep pressure. GHB (50 mg/kg p.o.) and placebo were administered in 20 young male volunteers at 2:30 a.m., the time when GHB is typically given in narcolepsy, in a randomized, double-blinded, crossover manner. Drug effects on sleep architecture and electroencephalographic (EEG) sleep spectra were analyzed. In addition, current source density (CSD) analysis was employed to identify the effects of GHB on the brain electrical sources of neuronal oscillations. Moreover, lagged-phase synchronization (LPS) analysis was applied to quantify the functional connectivity among sleep-relevant brain regions. GHB prolonged slow-wave sleep (stage N3) at the cost of rapid eye movement (REM) sleep. Furthermore, it enhanced delta-theta (0.5-8 Hz) activity in NREM and REM sleep, while reducing activity in the spindle frequency range (13-15 Hz) in sleep stage N2. The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex. Theta power was particularly increased in the prefrontal cortex and both temporal poles. Moreover, the brain areas that showed increased theta power after GHB also exhibited increased lagged-phase synchronization among each other. Our study in healthy men revealed distinct similarities between GHB-augmented sleep and physiologically augmented sleep as seen in recovery sleep after prolonged wakefulness. The promotion of the sleep neurophysiological mechanisms by GHB may thus provide a rationale for GHB-induced sleep and waking quality in neuropsychiatric disorders beyond narcolepsy.",2019,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","['20 young male volunteers', 'healthy men', 'male healthy volunteers']","['gamma-hydroxybutyrate augmented sleep', 'placebo', 'GHB', 'Gamma-hydroxybutyrate (GHB']","['sleep architecture and electroencephalographic (EEG) sleep spectra', 'delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex', 'biomimetic sleep enhancement', 'GHB prolonged slow-wave sleep (stage N3', 'Theta power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228243', 'cui_str': 'Gyrus Fusiformis'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0872312', 'cui_str': 'Biomimicry Engineering'}, {'cui': 'C0184578', 'cui_str': 'Sleep/wake cycle facilitation'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",20.0,0.0596478,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland. dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0382-z']
422,31386610,Phase II Trial of Cediranib in Combination With Cisplatin and Pemetrexed in Chemotherapy-Naïve Patients With Unresectable Malignant Pleural Mesothelioma (SWOG S0905).,"PURPOSE
Antiangiogenic agents combined with chemotherapy have efficacy in the treatment of unresectable malignant pleural mesothelioma (MPM). Cediranib (AstraZeneca, Cheshire, United Kingdom), a vascular endothelial growth factor receptor and platelet-derived growth factor receptor inhibitor, demonstrated therapeutic potential in a prior phase I trial. We evaluated a phase II trial for efficacy.
PATIENTS AND METHODS
SWOG S0905 (ClinicalTrials.gov identifier: NCT01064648) randomly assigned cediranib or placebo with platinum-pemetrexed for six cycles followed by maintenance cediranib or placebo in unresectable chemotherapy-naïve patients with MPM of any histologic subtype. Primary end point was Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 progression-free survival (PFS). Secondary end points included overall survival, PFS by modified RECIST v1.1, response (modified RECIST and RECIST v1.1), disease control, and safety/toxicity. The trial was designed to detect a difference in RECIST v1.1 PFS at the one-sided 0.1 level using a stratified log-rank test.
RESULTS
Ninety-two eligible patients were enrolled (75% epithelioid and 25% biphasic or sarcomatoid). The cediranib arm had more grade 3 and 4 diarrhea, dehydration, hypertension, and weight loss. Cediranib improved PFS by RECIST v1.1 (hazard ratio, 0.71; 80% CI, 0.54 to 0.95; P = .062; 7.2 months v 5.6 months) and increased modified RECIST v1.1 response (50% v 20%; P = .006). By modified RECIST v1.1, cediranib numerically increased PFS (hazard ratio, 0.77; 80% CI, 0.59 to 1.02; P = .12; median, 6.9 months v 5.6 months). No significant difference in overall survival was observed.
CONCLUSION
The addition of cediranib to platinum-pemetrexed improved PFS by RECIST v1.1 and response rate by modified RECIST in patients with unresectable MPM. Whereas adding antiangiogenics to chemotherapy has been a successful strategy for some patients, the cediranib toxicity profile and small incremental survival benefit precludes additional development in MPM.",2019,"By modified RECIST v1.1, cediranib numerically increased PFS (hazard ratio, 0.77; 80% CI, 0.59 to 1.02; P = .12; median, 6.9 months v 5.6 months).","['Ninety-two eligible patients were enrolled (75% epithelioid and 25% biphasic or sarcomatoid', 'patients with unresectable MPM', 'unresectable chemotherapy-naïve patients with MPM of any histologic subtype', 'unresectable malignant pleural mesothelioma (MPM', 'Chemotherapy-Naïve Patients With Unresectable Malignant Pleural Mesothelioma (SWOG S0905']","['cediranib or placebo', 'Cediranib', 'cediranib or placebo with platinum-pemetrexed', 'Cisplatin and Pemetrexed', 'chemotherapy', 'Cediranib (AstraZeneca, Cheshire, United Kingdom']","['grade 3 and 4 diarrhea, dehydration, hypertension, and weight loss', 'modified RECIST v1.1 response', 'PFS', 'overall survival', 'Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 progression-free survival (PFS', 'overall survival, PFS by modified RECIST v1.1, response (modified RECIST and RECIST v1.1), disease control, and safety/toxicity']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}]","[{'cui': 'C1698364', 'cui_str': '4-((4-Fluoro-2-methyl-1H-indol-5-yl)oxy)-6-methoxy-7-(3-(pyrrolidin-1-yl)propoxy)quinazoline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0454844', 'cui_str': 'Cheshire (geographic location)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",92.0,0.171406,"By modified RECIST v1.1, cediranib numerically increased PFS (hazard ratio, 0.77; 80% CI, 0.59 to 1.02; P = .12; median, 6.9 months v 5.6 months).","[{'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Ignacio I', 'Initials': 'II', 'LastName': 'Wistuba', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'US Oncology Comprehensive Cancer Centers of Nevada, Las Vegas, NV.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Frank V', 'Initials': 'FV', 'LastName': 'Fossella', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mario R', 'Initials': 'MR', 'LastName': 'Velasco', 'Affiliation': 'Cancer Care Specialists of Illinois, Decatur, IL.'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Box-Noriega', 'Affiliation': 'Kaiser Permanente, Fresno, CA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Hueftle', 'Affiliation': 'Montana Cancer Consortium, Billings, MT.'}, {'ForeName': 'Shirish', 'Initials': 'S', 'LastName': 'Gadgeel', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, CA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00269']
423,32286687,Patient-reported outcomes from KATHERINE: A phase 3 study of adjuvant trastuzumab emtansine versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2-positive breast cancer.,"BACKGROUND
The phase 3 KATHERINE trial demonstrated significantly improved invasive disease-free survival with adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab in patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy.
METHODS
Patients who received taxane- and trastuzumab-containing neoadjuvant therapy (with/without anthracyclines) and had residual invasive disease (breast and/or axillary nodes) at surgery were randomly assigned to 14 cycles of adjuvant T-DM1 (3.6 mg/kg intravenously every 3 weeks) or trastuzumab (6 mg/kg intravenously every 3 weeks). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and breast cancer module (QLQ-BR23) were completed at screening, at day 1 of cycles 5 and 11, within 30 days after study drug completion, and at 6- and 12-month follow-up visits.
RESULTS
Of patients who were randomly assigned to T-DM1 (n = 743) and trastuzumab (n = 743), 612 (82%) and 640 (86%), respectively, had valid baseline and ≥1 postbaseline assessments. No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm. More patients receiving T-DM1 reported clinically meaningful deterioration at any assessment point in role functioning (49% vs 41%), appetite loss (38% vs 28%), constipation (47% vs 38%), fatigue (66% vs 60%), nausea/vomiting (39% vs 30%), and systemic therapy side effects (49% vs 36%). These differences were no longer apparent at the 6-month follow-up assessment, except for role functioning (23% vs 16%).
CONCLUSION
These data suggest that health-related quality of life was generally maintained in both study arms over the course of treatment.",2020,No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm.,"['Patients who received', 'patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2-positive breast cancer', 'patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy', 'with/without anthracyclines) and had residual invasive disease (breast and/or axillary nodes) at surgery']","['adjuvant trastuzumab emtansine versus trastuzumab', 'adjuvant T-DM1', 'adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab', 'taxane- and trastuzumab-containing neoadjuvant therapy', 'trastuzumab']","['meaningful deterioration', 'appetite loss', 'mean QLQ-C30 and QLQ-BR23 scores', 'invasive disease-free survival', 'systemic therapy side effects', 'Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and breast cancer module (QLQ-BR23', 'fatigue', 'constipation', 'quality of life', 'nausea/vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",743.0,0.0808795,No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm.,"[{'ForeName': 'PierFranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'DiSCOG, University of Padova and Division of Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'GBG, Neu-Isenburg, Germany.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NSABP Foundation and Orlando Health University of Florida Health Cancer Center, Orlando, Florida.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'GBG, Neu-Isenburg, Germany.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Mano', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'AGO-B and HELIOS Klinikum Berlin Buch, Berlin, Germany.'}, {'ForeName': 'Chiun-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation and University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NSABP Foundation and University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': ""D'Hondt"", 'Affiliation': 'Institut Régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Redondo', 'Affiliation': 'Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Ljiljana', 'Initials': 'L', 'LastName': 'Stamatovic', 'Affiliation': 'Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Bonnefoi', 'Affiliation': 'Institut Bergonié Unicancer and Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Castro-Salguero', 'Affiliation': 'Grupo Medico Angeles, Guatemala City, Guatemala.'}, {'ForeName': 'Hans H', 'Initials': 'HH', 'LastName': 'Fischer', 'Affiliation': 'GBG and Evangelische Kliniken Gelsenkirchen, Gelsenkirchen, Germany.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Wahl', 'Affiliation': 'Swedish Cancer Institute, Issaquah, Washington.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boulet', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trask', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NSABP Foundation and Houston Methodist Cancer Center, Houston, Texas.'}]",Cancer,['10.1002/cncr.32873']
424,32247517,A Bidirectional Analysis of Feeding Practices and Eating Behaviors in Parent/Child Dyads from Low-Income and Minority Households.,"OBJECTIVE
To prospectively examine the bidirectional relationship between parental feeding practices (eg, instrumental feeding, encouragement to eat) and child eating behaviors (eg, food responsiveness, emotional eating) in low-income, ethnically diverse preschool children over a 3-year period.
STUDY DESIGN
Parent/child (age 2-4 years at baseline) pairs (n = 222 non-Hispanics; n = 312 Hispanics) participated in NET-Works (Now Everybody Together for Amazing and Healthful Kids), a randomized controlled trial carried out in community and in-home settings in urban areas of Minnesota. Data were collected at baseline and 12, 24, and 36 months. The present study is a secondary data analysis using cross-lagged models to identify bidirectional associations between parental feeding practices and child eating behaviors.
RESULTS
Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety. Model 1 showed significant bidirectional temporal paths, whereas models 2 and 3 showed significant unidirectional temporal paths from parental feeding practices to child eating behaviors.
CONCLUSIONS
Parental instrumental and emotional feeding practices prospectively influence child food responsiveness and satiety. This study demonstrates causal temporality between parental feeding practices and child eating behaviors. Heath care providers may want to use findings regarding parent feeding practices as part of their anticipatory guidance during well-child visits with parents of preschoolers.",2020,"RESULTS
Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety.","['Parent/child (age 2-4\xa0years at baseline) pairs (n\xa0=\xa0222 non-Hispanics; n\xa0=\xa0312 Hispanics) participated in', 'low-income, ethnically diverse preschool children over a 3-year period', 'Parent/Child Dyads from Low-Income and Minority Households', 'parental feeding practices and child eating behaviors', 'community and in-home settings in urban areas of Minnesota']",['NET-Works '],"['parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety', 'child eating behaviors (eg, food responsiveness, emotional eating']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0322418,"RESULTS
Three models showed significant cross-lagged effects (P < .05): model 1, parental instrumental feeding influencing later child food responsiveness; model 2, parental emotional feeding influencing later child food responsiveness; and model 3, parental emotional feeding influencing later child eating satiety.","[{'ForeName': 'Jerica M', 'Initials': 'JM', 'LastName': 'Berge', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN. Electronic address: jberge@umn.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Veblen-Mortenson', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Kunin-Batson', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Sherwood', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'French', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.001']
425,31081862,Association of Intensive Blood Pressure Reduction With Risk of Hematoma Expansion in Patients With Deep Intracerebral Hemorrhage.,"Importance
Hypertension is the strongest risk factor for spontaneous intracerebral hemorrhage (ICH) involving deep brain regions, but it appears to be unknown if intensive blood pressure reduction in the acute care setting decreases hematoma expansion or improves outcomes in patients with deep ICH.
Objective
To determine whether intensive blood pressure reduction is associated with decreased risk of hematoma expansion and changes in 90-day modified Rankin Scale scores and if these associations are modified by the specific deep-brain nuclei involved.
Design, Setting, and Participants
This study is an exploratory analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage-2 international, multicenter randomized clinical trial, which was conducted from May 2011 to September 2015, enrolled eligible patients with primary ICH, and followed up with them for 90 days. Patients who had ICH and complete neuroimaging data were included in the analysis. Data analysis was completed from July 2018 to December 2018.
Exposures
Participants were randomized to either intensive treatment (with a systolic blood pressure target of 110-139 mm Hg) or standard treatment (with a systolic blood pressure target of 140-179 mm Hg).
Main Outcomes and Measures
The main outcome was hematoma expansion, defined as an increase greater than 33% in hematoma volume between baseline and 24 hours. Functional outcome was evaluated 90 days after the ICH via the modified Rankin Scale.
Results
Of 1000 trial participants, 870 (87.0%) had deep ICH, of whom 780 (89.7%) had complete neuroimaging data (of 336 thalamic and 444 basal ganglia hemorrhages). The baseline characteristics of the intensive and standard treatment groups remained balanced in this subgroup of the original study. Intensive treatment was associated with a decreased risk of hematoma expansion in univariable analysis (odds ratio [OR], 0.62 [95% CI, 0.43-0.87]; P = .006) and multivariable analysis (OR, 0.61 [95% CI, 0.42-0.88]; P = .009). This association was modified by the specific deep location of the ICH (OR, 0.44 [95% CI, 0.22-0.96]; interaction P = .02), with stratified analyses showing a reduction in risk of hematoma expansion with intensive vs standard treatment among basal ganglia ICH (OR, 0.44 [95% CI, 0.27-0.72]; P = .001) but not thalamic ICH (OR, 0.91 [95% CI, 0.51-0.64]; P = .76). Intensive treatment was not associated with an improvement in the modified Rankin Scale score distribution.
Conclusions and Relevance
Compared with standard treatment, intensive blood pressure treatment was associated with reduced hematoma expansion in deep ICH, specifically among basal ganglia hemorrhages.",2019,"Intensive treatment was not associated with an improvement in the modified Rankin Scale score distribution.
","['2011 to September 2015, enrolled eligible patients with primary ICH, and followed up with them for 90 days', 'Patients who had ICH and complete neuroimaging data were included in the analysis', '1000 trial participants, 870 (87.0%) had deep ICH, of whom 780 (89.7%) had complete neuroimaging data (of 336 thalamic and 444 basal ganglia hemorrhages', 'Patients With Deep Intracerebral Hemorrhage', 'patients with deep ICH']",['intensive treatment (with a systolic blood pressure target of 110-139 mm Hg) or standard treatment (with a systolic blood pressure target of 140-179 mm Hg'],"['risk of hematoma expansion', 'hematoma volume', 'hematoma expansion', 'modified Rankin Scale score distribution', '90-day modified Rankin Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.222201,"Intensive treatment was not associated with an improvement in the modified Rankin Scale score distribution.
","[{'ForeName': 'Audrey C', 'Initials': 'AC', 'LastName': 'Leasure', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, St Cloud, Minnesota.'}, {'ForeName': 'Santosh B', 'Initials': 'SB', 'LastName': 'Murthy', 'Affiliation': 'Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Kamel', 'Affiliation': 'Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Woo', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Ziai', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Matouk', 'Affiliation': 'Department of Neurosurgery, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Sansing', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, Connecticut.'}]",JAMA neurology,['10.1001/jamaneurol.2019.1141']
426,31083074,"A Randomized Cross-over Trial Comparing a Pressure-free, Adhesive to a Conventional Bone Conduction Hearing Device.","OBJECTIVES
The main aim of this study was to compare the average daily wearing time of a conventional bone conduction device with a pressure-free, adhesive bone conduction device. Further, audiologic and quality-of-life outcome parameters were evaluated.
METHODS
An academic, prospective, randomized cross-over trial was performed at a single center.Thirteen subjects between 12 and 63 years with conductive hearing loss were included.Average daily wearing time and subjective observations were assessed in a diary. Sound field audiometry, Freiburg monosyllables word test, and Oldenburg sentence test in quiet and in noise were carried out after 2 weeks of habituation to each device. AQoL-8D and SSQ-12 questionnaires were completed at baseline and after a 2-week test interval.
RESULTS
Median wearing time of the devices was 8.1 hours (5.8-10.2 interquartile range) for the adhesive and 4.3 hours (2.7-7.1) for the conventional bone conduction device, the difference was statistically significant (p = 0.033). There were no statistically significant differences in sound field audiometry, Freiburg monosyllables word test, and Oldenburg sentence test when comparing the two devices. AQoL-8D and SSQ-12 showed a significant improvement with the devices in comparison with baseline, with no significant difference between devices in the total scores. Ten subjects reported pain using the conventional device, two subjects reported skin irritations using the adhesive device.
CONCLUSION
For patients with mixed or conductive hearing loss, the adhesive device is a valuable alternative with a significantly longer daily wearing time.",2019,"AQoL-8D and SSQ-12 showed a significant improvement with the devices in comparison with baseline, with no significant difference between devices in the total scores.","['patients with mixed or conductive hearing loss', 'Thirteen subjects between 12 and 63 years with conductive hearing loss were included']","['Sound field audiometry, Freiburg monosyllables word test, and Oldenburg sentence test in quiet and in noise', 'conventional bone conduction device with a pressure-free, adhesive bone conduction device']","['AQoL-8D and SSQ-12 questionnaires', 'skin irritations', 'sound field audiometry, Freiburg monosyllables word test, and Oldenburg sentence test', 'Average daily wearing time and subjective observations', 'Median wearing time of the devices']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss (disorder)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0004286', 'cui_str': 'Audiometry'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0005935', 'cui_str': 'Bone Conduction Hearing'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0004286', 'cui_str': 'Audiometry'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",,0.0937828,"AQoL-8D and SSQ-12 showed a significant improvement with the devices in comparison with baseline, with no significant difference between devices in the total scores.","[{'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Dahm', 'Affiliation': 'Department of Otorhinolaryngology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Auinger', 'Affiliation': ''}, {'ForeName': 'Rudolfs', 'Initials': 'R', 'LastName': 'Liepins', 'Affiliation': ''}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Baumgartner', 'Affiliation': ''}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Riss', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Arnoldner', 'Affiliation': ''}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002184']
427,31083077,"Efficacy and Safety of AM-111 in the Treatment of Acute Unilateral Sudden Deafness-A Double-blind, Randomized, Placebo-controlled Phase 3 Study.","OBJECTIVE
To confirm the efficacy and safety of AM-111 (brimapitide), a cell-penetrating c-Jun N-terminal Kinase (JNK) inhibitor, in patients suffering from severe to profound acute unilateral idiopathic sudden sensorineural hearing loss (ISSNHL).
STUDY DESIGN
Prospective, double-blind, randomized, placebo-controlled phase 3 study with follow-up visits on Days 3, 7, 28, and 91.
SETTING
Fifty-one European and Asian sites (tertiary referral centers, private ENT practices).
PATIENTS
Two hundred fifty-six patients aged 18 to 65 years presenting within 72 hours following ISSNHL onset with mean hearing loss ≥ 40 dB and mean threshold ≥ 60 dB at the 3 worst affected contiguous test frequencies.
INTERVENTIONS
Single-dose intratympanic injection of AM-111 (0.4 or 0.8 mg/ml) or placebo; oral prednisolone as reserve therapy if hearing improvement < 10 dB at Day 7.
MAIN OUTCOME MEASURES
Hearing improvement to Day 28 was the primary efficacy endpoint; complete hearing recovery, frequency of reserve therapy used, complete tinnitus remission, improvement in word recognition were secondary endpoints. Safety was evaluated by the frequency of clinically relevant hearing deterioration and adverse events.
RESULTS
While the primary efficacy endpoint was not met in the overall study population, post-hoc analysis showed a clinically relevant and nominally significant treatment effect for AM-111 0.4 mg/ml in patients with profound ISSNHL. The study drug and the administration procedure were well tolerated.
CONCLUSIONS
AM-111 provides effective otoprotection in case of profound ISSNHL. Activation of the JNK stress kinase, AM-111's pharmacologic target, seems to set in only following pronounced acute cochlear injury associated with large hearing threshold shifts.",2019,"While the primary efficacy endpoint was not met in the overall study population, post-hoc analysis showed a clinically relevant and nominally significant treatment effect for AM-111 0.4 mg/ml in patients with profound ISSNHL.","['patients suffering from severe to profound acute unilateral idiopathic sudden sensorineural hearing loss (ISSNHL', 'Acute Unilateral Sudden Deafness', 'Fifty-one European and Asian sites (tertiary referral centers, private ENT practices', 'Two hundred fifty-six patients aged 18 to 65 years presenting within 72\u200ahours following ISSNHL onset with mean hearing loss ≥']","['placebo', 'AM-111', 'Placebo', 'placebo; oral prednisolone', 'AM-111 (brimapitide), a cell-penetrating c-Jun N-terminal Kinase (JNK) inhibitor']","['Efficacy and Safety', 'hearing recovery, frequency of reserve therapy used, complete tinnitus remission, improvement in word recognition', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439808', 'cui_str': 'Profundis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss (disorder)'}, {'cui': 'C1148477', 'cui_str': 'Deafness, Sudden'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C1274038', 'cui_str': 'Ear, nose and throat surgery'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2003373', 'cui_str': 'AM111 peptide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205321', 'cui_str': 'Penetrating (qualifier value)'}, {'cui': 'C0248813', 'cui_str': 'JNK Mitogen-Activated Protein Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}]",256.0,0.425813,"While the primary efficacy endpoint was not met in the overall study population, post-hoc analysis showed a clinically relevant and nominally significant treatment effect for AM-111 0.4 mg/ml in patients with profound ISSNHL.","[{'ForeName': 'Hinrich', 'Initials': 'H', 'LastName': 'Staecker', 'Affiliation': 'Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas, U.S.A.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Jokovic', 'Affiliation': 'ENT Hospital ""Dr Dragiša MIšović-Dedinje"", Belgrade, Serbia.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Karpishchenko', 'Affiliation': 'ENT Department, Pavlov First Saint Petersburg State Medical University, St Petersburg, Russia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kienle-Gogolok', 'Affiliation': 'Private ENT practice, Bad Schönborn, Germany.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Krzyzaniak', 'Affiliation': 'Department of ENT, 10th Military Hospital, Bydgoszcz, Poland.'}, {'ForeName': 'Chia-Der', 'Initials': 'CD', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Navratil', 'Affiliation': 'Private ENT practice, Olomouc, Czech Republic.'}, {'ForeName': 'Ventzislav', 'Initials': 'V', 'LastName': 'Tzvetkov', 'Affiliation': 'Department of Otolaryngology, Military Medical Academy, Sofia, Bulgaria.'}, {'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Wright', 'Affiliation': 'Department of Otolaryngology, Thammasat University Hospital, Pathum Thani, Thailand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Auris Medical AG, Basel, Switzerland.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002229']
428,32179197,Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial.,"OBJECTIVES
To investigate the effects of lower limb strength training in addition to neuromuscular exercise and education (ST + NEMEX-EDU) compared to neuromuscular exercise and education alone (NEMEX-EDU) on self-reported physical function in patients with knee osteoarthritis (KOA).
DESIGN
Patient-blinded, parallel-group randomized controlled trial (RCT).
METHODS
The trial included 90 patients in secondary care with radiographic and symptomatic KOA, ineligible for knee replacement. Both groups exercised twice weekly for 12 weeks. Additional strength training consisted of a single, fatiguing knee extension set (30-60RM) before four sets of leg-press (8-12RM). Primary outcome was the between-group difference on the subscale activities of daily living from the Knee Injury and Osteoarthritis Outcome Score (KOOS ADL ) at 12 weeks. Secondary outcomes included KOOS symptoms, pain, function in sport and recreation, and quality of life, 40 m walk, stair climb, leg extension power, EuroQol-5D-5L, pain medication usage, and adverse events.
RESULTS
There was no statistically significant between-group difference in KOOS ADL at 12-weeks; adjusted mean difference -1.15 (-6.78 to 4.48). Except for the stair climb test, which demonstrated an adjusted mean difference of 1.15 (0.09-2.21) in favor of ST + NEMEX-EDU, all other outcomes showed no statistically significant between-group differences. Neither group improved leg extension power.
CONCLUSION
The addition of lower-limb strength training, using a low-dose approach, to neuromuscular exercise and education carried no additional benefits on self-reported physical function or on most secondary outcomes. Both groups displayed similar improvements at 12-week follow-up. Hence, the current low-dose strength training approach provided no additional clinical value in this group of KOA patients. Trial identifier (ClinicalTrials.gov): NCT03215602.",2020,There was no statistically significant between-group difference in KOOS ADL at 12-weeks; adjusted mean difference,"['patients with knee osteoarthritis (KOA', '90 patients in secondary care with radiographic and symptomatic KOA, ineligible for knee replacement', 'patients with knee osteoarthritis in secondary care ']","['neuromuscular exercise and education (ST+NEMEX-EDU', 'Low-dose strength training', 'lower limb strength training', 'neuromuscular exercise and education', 'neuromuscular exercise and education alone (NEMEX-EDU']","['KOOS ADL', 'KOOS symptoms, pain, function during sport and recreation, and quality of life, 40m walk, stair climb, leg extension power, EuroQol-5D-5L, pain medication usage, and adverse events', 'subscale activities of daily living from the Knee Injury and Osteoarthritis Outcome Score (KOOS ADL ', 'leg extension power']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2927798', 'cui_str': 'Nemex'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0034380'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",90.0,0.118503,There was no statistically significant between-group difference in KOOS ADL at 12-weeks; adjusted mean difference,"[{'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Holm', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Slagelse & Næstved, Denmark. Electronic address: pamh@regionsjaelland.dk.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Schrøder', 'Affiliation': 'Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals, Næstved, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wernbom', 'Affiliation': 'Center for Health and Performance, Department of Food and Nutrition and Sport Science, University of Gothenburg, Gothenburg, Sweden; Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Slagelse & Næstved, Denmark.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.02.839']
429,31577356,Effect of a Novel Transition Program on Disability After Stroke: A Trial Protocol.,"Importance
A gap in care for stroke survivors exists at the point of transition from inpatient rehabilitation to home, when survivors encounter new environmental barriers because of the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have the potential to significantly improve stroke survivors' long-term morbidity.
Objective
To investigate the efficacy and safety of a novel enhanced rehabilitation transition program to reduce environmental barriers and improve daily activity performance and community participation among stroke survivors.
Design, Setting, and Participants
This is a phase 2b, single-blind, parallel-group, randomized clinical trial. Participants will be randomized using a 1:1 allocation ratio, stratified by Functional Independence Measure and age, to either attentional control or the intervention. Community Participation Transition After Stroke (COMPASS) is a complex intervention that uses 2 complementary evidence-based interventions: home modifications and strategy training delivered in the home. Community participation after stroke, measured by the Reintegration to Normal Living Index, is the primary outcome. Secondary outcomes include quality of life after stroke, measured by the Stroke Impact Scale, and daily activity performance and magnitude of environmental barriers in the home, both measured by the In-Home Occupational Performance Evaluation. An intention-to-treat analysis will be used. A total of 180 participants, who are 50 years or older, were independent in activities of daily living prior to stroke, and are undergoing inpatient rehabilitation following stroke with a plan to be discharged home, will be included in the study.
Discussion
Stroke is a leading cause of serious long-term disability in the United States. The COMPASS study is ongoing. To date, 99 participants have been recruited and 77 randomized, with 37 in the treatment group and 40 in the control group. Resumption of previous activities immediately after discharge can improve immediate and long-term community participation. Results from this study will fill a critical gap in stroke rehabilitation evidence by providing important information about the long-term community participation and daily activity performance among stroke survivors as well as environmental barriers in their homes.
Trial Registration
ClinicalTrials.gov identifier: NCT03485820.",2019,"A total of 180 participants, who are 50 years or older, were independent in activities of daily living prior to stroke, and are undergoing inpatient rehabilitation following stroke with a plan to be discharged home, will be included in the study.
","['99 participants have been recruited and 77 randomized, with 37 in the treatment group and 40 in the control group', '180 participants, who are 50 years or older, were independent in activities of daily living prior to stroke, and are undergoing inpatient rehabilitation following stroke with a plan to be discharged home, will be included in the study']","['Novel Transition Program', 'novel enhanced rehabilitation transition program']","['quality of life after stroke, measured by the Stroke Impact Scale, and daily activity performance and magnitude of environmental barriers in the home, both measured by the In-Home Occupational Performance Evaluation', 'efficacy and safety', 'daily activity performance', 'Disability']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0034380'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",180.0,0.161571,"A total of 180 participants, who are 50 years or older, were independent in activities of daily living prior to stroke, and are undergoing inpatient rehabilitation following stroke with a plan to be discharged home, will be included in the study.
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Somerville', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Minor', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Keglovits', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stark', 'Affiliation': 'School of Medicine, Washington University in St Louis, St Louis, Missouri.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.12356']
430,32283078,Is There a Difference in Volumetric Change and Effectiveness Comparing Pedicled Buccal Fat Pad and Abdominal Fat When Used as Interpositional Arthroplasty in the Treatment of Temporomandibular Joint Ankylosis?,"PURPOSE
There is limited evidence in the literature about fat grafting in the management of temporomandibular joint ankylosis (TMJA). The purpose was to investigate which interpositional fat grafting technique is superior in the operative management of TMJA. The specific aim was to compare the volumetric change and maximal mouth opening (MIO) when pedicled buccal fat or abdominal fat is interposed in patients being treated for TMJA.
PATIENTS AND METHODS
A randomized controlled trial was conducted on TMJA patients divided into 2 groups: Pedicled buccal fat pad was used for interposition in group A, whereas abdominal fat was used in group B. At the end of 1 year, the volumetric change in fat was analyzed by comparing immediate postoperative and 1-year follow-up magnetic resonance imaging (MRI). MIO and re-ankylosis were recorded. Categorical variables were analyzed by the χ 2 test or Fisher exact test. Continuous variables were compared using the t test and Wilcoxon signed rank test. Linear regression analysis was performed.
RESULTS
A total of 36 patients (51 joints [15 bilateral and 21 unilateral]) were included, comprising 18 in group A and 18 in group B. The mean preoperative MIO measured 6.8 mm in group A and 4.2 mm in group B. The mean immediate postoperative MRI fat volume was 4.3 cm 3 in group A and 10.8 cm 3 in group B. One-year follow-up MRI showed a fat retention rate of 32.44% in group A and 58.17% in group B. The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001). Analysis of variance showed a statistically significant difference between volumetric shrinkage and both treatment groups (P < .001). MIO improved to 30.6 mm in the pedicled buccal fat pad group (group A) and 41.9 mm in the abdominal fat group (group B) (P < .001). No re-ankylosis occurred in either group at 1-year follow-up.
CONCLUSIONS
Our study results suggest that the percentage of retention of interposed abdominal fat at 1 year is more than that of pedicled buccal fat pad. Volumetric shrinkage is greater with buccal fat pad, which is a paradox considering the pedicled blood supply. Abdominal fat is better than pedicled buccal fat pad when used for interposition in TMJA treatment.",2020,The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001).,"['36 patients (51 joints [15 bilateral and 21 unilateral', 'patients being treated for TMJA', 'TMJA patients divided into 2 groups']",['Pedicled buccal fat pad was used for interposition'],"['fat retention rate', 'mean preoperative MIO', 'Volumetric Change and Effectiveness Comparing Pedicled Buccal Fat Pad and Abdominal Fat', 'MIO', 'percentage of retention of interposed abdominal fat', 'mean immediate postoperative MRI fat volume', 're-ankylosis', 'volumetric shrinkage', 'volumetric change and maximal mouth opening (MIO', 'Volumetric shrinkage', 'MIO and re-ankylosis', 'volumetric change in fat', 'rate of volumetric shrinkage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2931375', 'cui_str': 'Ankylosis of temporomandibular joint'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",36.0,0.055982,The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001).,"[{'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Department of Oral & Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi, India. Electronic address: ajoyroy@hotmail.com.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'Ex-Junior Resident, Department of Oral & Maxillofacial surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Department of Oral & Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Seith Bhalla', 'Affiliation': 'Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Manchanda', 'Affiliation': 'Associate Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Professor and Head, Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.03.006']
431,30901755,Postoperative structured rehabilitation in patients undergoing surgery for cervical radiculopathy: a 2-year follow-up of a randomized controlled trial.,"OBJECTIVE
Information about postoperative rehabilitation for cervical radiculopathy (CR) is scarce. The aim of this study was to investigate the additional benefits of structured postoperative rehabilitation (SPT), which was performed in all patients, compared with a pragmatic standard postoperative approach (SA), in which rehabilitation was used as needed and patients sought physiotherapy on their own without a referral, in patients with MRI evidence of disc herniation and concomitant clinical signs who underwent surgery for CR.
METHODS
Patients (n = 202) were randomized to receive SPT or SA. Included key variables in the present study were primary and selected secondary outcomes of a prospective randomized controlled multicenter study. The main outcome was the Neck Disability Index (NDI) score. The NDI score, pain variables, self-efficacy, and health-related quality of life were investigated at baseline and 3, 6, 12, and 24 months postoperatively.
RESULTS
SPT provided no additional benefits over SA (p = 0.08 to p = 0.99) at the postoperative 2-year follow-up. Both groups improved over time (p < 0.0001), with no reported adverse effects.
CONCLUSIONS
One can conclude that SPT offered no additional benefits over SA; however, patients tolerated postoperative neck exercises without any negative side effects. These findings are important for the development of future active and neck-specific postoperative rehabilitation interventions for patients with CR.Clinical trial registration no.: NCT01547611 (clinicaltrials.gov).",2019,SPT provided no additional benefits over SA (p = 0.08 to p = 0.99) at the postoperative 2-year follow-up.,"['patients undergoing surgery for cervical radiculopathy', 'Patients (n = 202', 'patients with MRI evidence of disc herniation and concomitant clinical signs who underwent surgery for CR']","['Postoperative structured rehabilitation', 'pragmatic standard postoperative approach (SA', 'structured postoperative rehabilitation (SPT', 'SPT', 'SPT or SA']","['adverse effects', 'NDI score, pain variables, self-efficacy, and health-related quality of life', 'tolerated postoperative neck exercises', 'Neck Disability Index (NDI) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0454347', 'cui_str': 'Neck exercises (regime/therapy)'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}]",202.0,0.266221,SPT provided no additional benefits over SA (p = 0.08 to p = 0.99) at the postoperative 2-year follow-up.,"[{'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Peolsson', 'Affiliation': '1Department of Medical and Health Sciences, Physiotherapy, Linköping University, Linköping.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Löfgren', 'Affiliation': '2Neuro-Orthopedic Center, Ryhov Hospital, Region Jönköping County, Jönköping.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Dedering', 'Affiliation': '3Allied Health Professionals Function, Function Area Occupational Therapy and Physiotherapy, Karolinska University Hospital, Stockholm.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Öberg', 'Affiliation': '1Department of Medical and Health Sciences, Physiotherapy, Linköping University, Linköping.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zsigmond', 'Affiliation': '5Department of Neurosurgery, Linköping University Hospital, Linköping; and.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hedevik', 'Affiliation': '1Department of Medical and Health Sciences, Physiotherapy, Linköping University, Linköping.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Wibault', 'Affiliation': '1Department of Medical and Health Sciences, Physiotherapy, Linköping University, Linköping.'}]",Journal of neurosurgery. Spine,['10.3171/2018.12.SPINE181258']
432,32286132,Enhanced Attention Using Head-mounted Virtual Reality.,"Some evidence suggests that experiencing a given scenario using virtual reality (VR) may engage greater attentional resources than experiencing the same scenario on a 2D computer monitor. However, the underlying neural processes associated with these VR-related effects, especially those pertaining to current consumer-friendly head-mounted displays of virtual reality (HMD-VR), remain unclear. Here, two experiments were conducted to compare task performance and EEG-based neural metrics captured during a perceptual discrimination task presented on two different viewing platforms. Forty participants (20-25 years old) completed this task using both an HMD-VR and traditional computer monitor in a within-group, randomized design. Although Experiment I ( n = 20) was solely behavioral in design, Experiment II ( n = 20) utilized combined EEG recordings to interrogate the neural correlates underlying potential performance differences across platforms. These experiments revealed that (1) there was no significant difference in the amount of arousal measured between platforms and (2) selective attention abilities in HMD-VR environment were enhanced from both a behavioral and neural perspective. These findings suggest that the allocation of attentional resources in HMD-VR may be superior to approaches more typically used to assess these abilities (e.g., desktop/laptop/tablet computers with 2D screens).",2020,"These findings suggest that the allocation of attentional resources in HMD-VR may be superior to approaches more typically used to assess these abilities (e.g., desktop/laptop/tablet computers with 2D screens).",['Forty participants (20-25 years old'],['HMD-VR and traditional computer monitor'],"['amount of arousal measured between platforms and (2) selective attention abilities in HMD-VR environment', 'attentional resources']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",40.0,0.0169519,"These findings suggest that the allocation of attentional resources in HMD-VR may be superior to approaches more typically used to assess these abilities (e.g., desktop/laptop/tablet computers with 2D screens).","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shanghai Jiao Tong University.'}, {'ForeName': 'Joaquin A', 'Initials': 'JA', 'LastName': 'Anguera', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Samirah V', 'Initials': 'SV', 'LastName': 'Javed', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Muḥammad Adeel', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Shanghai Jiao Tong University.'}, {'ForeName': 'Guoxing', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Shanghai Jiao Tong University.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'University of California, San Francisco.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01560']
433,31467447,"Parents of newborns in the NICU enrolled in genome sequencing research: hopeful, but not naïve.","PURPOSE
In 2014, our institution launched a randomized controlled trial (RCT) comparing rapid genome sequencing (GS) to standard clinical evaluations of infants with suspected genetic disorders. This study aimed to understand parental response to the use of GS for their newborn babies.
METHODS
Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information. We also collected information about participants' genetic literacy, genetic knowledge, numeracy, and symptoms of anxiety and depression.
RESULTS
The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial. The 12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information. Some reported the diagnosis led to changes in medical care. Participants showed understanding of some of the psychological risks of GS. For example, 21 (91.3%) agreed or strongly agreed that genetic testing could reveal disturbing results.
CONCLUSIONS
Parents who enrolled their newborn in a RCT of GS demonstrated awareness of a psychological risk, but generally held positive beliefs about GS and perceived the benefits outweighed the risk.",2020,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"['infants with suspected genetic disorders', 'Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information', 'Parents of newborns in the NICU enrolled in genome sequencing research', ""12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information""]",[],['psychological risks of GS'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0035168'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",128.0,0.0537586,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Berrios', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA. cdberrios@cmh.edu.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Koertje', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Noel-MacDonnell', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Soden', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lantos', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0644-5']
434,32151708,Changes in serum estrogenic activity during neoadjuvant therapy with letrozole and exemestane.,"The aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®), are widely used to treat estrogen receptor (ER) positive breast cancer in postmenopausal patients. In the setting of metastatic breast cancer, these drugs may be used after another causing new responses in selected patients after progressing on the first choice. The precise explanation for this ""lack of cross resistance"" is still missing. NEOLETEXE is a neoadjuvant, randomized, open-label, cross-over trial. Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled. All patients were randomized to treatment starting with either letrozole or exemestane for at least 2 months followed by another 2 months on the alternative AI. The total estrogenic activities in blood samples were determined using the AroER tri-screen assay developed in the Chen laboratory. Using this highly sensitive assay, estrogenic activity was detected at three time points for all patients. Importantly, a significantly higher total estrogenic activity was found during therapy with exemestane compared to letrozole in 21 out of 26 patients. When letrozole was included in the AroER tri-screen assay, the estrogenic activities in most samples collected during exemestane treatment were further reduced, suggesting that low levels of androgens remained in specimens obtained after exemestane treatment. Our results suggest the AroER tri-screen to be a very sensitive method to estimate the overall estrogen-mediated activity in human samples even during therapy with highly potent aromatase inhibitors. In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.",2020,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","['postmenopausal patients', 'Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled']","['letrozole', 'letrozole and exemestane', 'aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®', 'letrozole or exemestane', 'exemestane']","['total estrogenic activities in blood samples', 'serum estrogenic activity', 'estrogenic activity', 'serum estrogen activity', 'total estrogenic activity', 'estrogenic activities']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0876723', 'cui_str': 'Aromasin'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}]",26.0,0.0127101,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kanaya', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Torill', 'Initials': 'T', 'LastName': 'Sauer', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway.'}, {'ForeName': 'Daehoon', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Loeng', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Gravdehaug', 'Affiliation': 'Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Shiuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Geisler', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway. Electronic address: juergen.geisler@medisin.uio.no.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105641']
435,32145280,Effects of High-Intensity Interval Training After Stroke (the HIIT-Stroke Study): A Multicenter Randomized Controlled Trial.,"OBJECTIVE
To examine if 8 weeks of high-intensity interval training (HIIT) in addition to standard care would increase and maintain peak oxygen uptake (Vo 2peak ) more than standard care alone in patients with stroke.
DESIGN
This was a single-blind, multicenter, parallel group, randomized controlled trial.
SETTING
Specialized rehabilitation units at 3 Norwegian hospitals.
PARTICIPANTS
Participants (N=70), 3 months to 5 years after first-ever stroke, were randomly assigned to the intervention group (n=36) or the control group (n=34); 42% were women, mean age was 57.6±9.3 years, mean time post stroke was 26.4±14.5 months.
INTERVENTION
The intervention was 8 weeks: 3 times a week with HIIT treadmill training with work periods of 4 × 4 minutes at 85%-95% of peak heart rate interspersed with 3 minutes of active recovery at 50%-70% of peak heart rate. The control group received standard care according to national guidelines.
OUTCOMES
The primary outcome, analyzed by intention-to-treat, was Vo 2peak measured as liters per minute 12 months after inclusion. Secondary outcome measures were blood pressure and blood profile.
RESULTS
Mean baseline Vo 2peak was 2.63±1.08 L·min -1 vs 2.87±0.71 L·min -1 , while at 12 months Vo 2peak was 2.70±1.00 L·min -1 vs 2.67±0.76 L·min -1 (P=.068) in the intervention and control groups, respectively. There was a significant and greater improvement in the intervention group compared with the control group at 12 months in 3 of 6 secondary outcomes from the peak test but no significant differences for blood pressure or blood profile.
CONCLUSIONS
The HIIT intervention, which was well-tolerated in this sample of well-functioning survivors of stroke, was not superior to standard care in improving and maintaining Vo 2peak at the 12-month follow-up. However, secondary results from the peak test showed a significant improvement from before to immediately after the intervention.",2020,"There was a significant and greater improvement in the intervention group compared to the control group at 12 months in three out of six secondary outcomes from the peak test, but no significant differences for the blood pressure or blood profile.
","['n=34), 42% women, mean (SD) age was 57.6 (9.3) years and 26.4 (14.5) months post-stroke', 'Participants, three months to five years after first-ever stroke', 'Specialized rehabilitation units at three Norwegian hospitals', 'patients with stroke']","['control group', 'standard care according to national guidelines', 'high-intensity interval training (HIIT', 'High-Intensity Interval Training']","['blood pressure or blood profile', 'blood pressure and blood profile', 'Mean (SD) baseline VO 2peak', 'maintain peak oxygen uptake (VO 2peak ', 'intention-to-treat, was VO 2peak measured as liters per minute']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005768'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0702093', 'cui_str': '/min'}]",,0.153526,"There was a significant and greater improvement in the intervention group compared to the control group at 12 months in three out of six secondary outcomes from the peak test, but no significant differences for the blood pressure or blood profile.
","[{'ForeName': 'Tor Ivar', 'Initials': 'TI', 'LastName': 'Gjellesvik', 'Affiliation': ""Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Physical Medicine and Rehabilitation, St Olav's University Hospital, Trondheim, Norway. Electronic address: tor.i.gjellesvik@ntnu.no.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Becker', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Faculty of Medicine, Oslo, Norway.'}, {'ForeName': 'Arnt Erik', 'Initials': 'AE', 'LastName': 'Tjønna', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; NeXt Move, NTNU, Trondheim, Norway.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Indredavik', 'Affiliation': ""Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Stroke Unit, Department of Internal Medicine, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Halvard', 'Initials': 'H', 'LastName': 'Nilsen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ålesund Hospital, Ålesund, Norway.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Brurok', 'Affiliation': ""Department of Physical Medicine and Rehabilitation, St Olav's University Hospital, Trondheim, Norway; Centre for Elite Sports Research, Department of Neuromedicine and Movement Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Tørhaug', 'Affiliation': ""Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Physical Medicine and Rehabilitation, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Busuladzic', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Torunn', 'Initials': 'T', 'LastName': 'Askim', 'Affiliation': ""Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Stroke Unit, Department of Internal Medicine, St Olav's University Hospital, Trondheim, Norway.""}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.006']
436,30744430,Bronchoalveolar fluid and plasma inflammatory biomarkers in contemporary ARDS patients.,"Purpose: Bronchoalveolar fluid (BALF) and plasma biomarkers are often endpoints in early phase randomized trials (RCTs) in acute respiratory distress syndrome (ARDS). With ARDS mortality decreasing, we analyzed baseline biomarkers in samples from contemporary ARDS patients participating in a prior RCT and compared these to historical controls. Materials and methods: Ninety ARDS adult patients enrolled in the parent trial. BALF and blood were collected at baseline, day 4 ± 1, and day 8 ± 1. Interleukins-8/-6/-1β/-1 receptor antagonist/-10; granulocyte colony stimulating factor; monocyte chemotactic protein-1; tumour necrosis factor-α; surfactant protein-D; von Willebrand factor; leukotriene B 4 ; receptor for advanced glycosylation end products; soluble Fas ligand; and neutrophil counts were measured. Results: Compared to historical measurements, our values were generally substantially lower, despite our participants being similar to historical controls. For example, our BALF IL-8 and plasma IL-6 were notably lower than in a 1999 RCT of low tidal volume ventilation and a 2007 biomarker study, respectively. Conclusions: Baseline biomarker levels in current ARDS patients are substantially lower than 6-20 years before collection of these samples. These findings, whether from ICU care changes resulting in less inflammation or from variation in assay techniques over time, have important implications for design of future RCTs with biomarkers as endpoints.",2019,"Compared to historical measurements, our values were generally substantially lower, despite our participants being similar to historical controls.","['acute respiratory distress syndrome (ARDS', 'Ninety ARDS adult patients enrolled in the parent trial', 'contemporary ARDS patients']",['Bronchoalveolar fluid (BALF'],"['BALF and blood', 'BALF IL-8 and plasma IL-6', 'Bronchoalveolar fluid and plasma inflammatory biomarkers']","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]","[{'cui': 'C0005768'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",90.0,0.12953,"Compared to historical measurements, our values were generally substantially lower, despite our participants being similar to historical controls.","[{'ForeName': 'Renee D', 'Initials': 'RD', 'LastName': 'Stapleton', 'Affiliation': 'a Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Vermont College of Medicine , Burlington , VT , USA.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Suratt', 'Affiliation': 'a Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Vermont College of Medicine , Burlington , VT , USA.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Neff', 'Affiliation': 'b Department of Medicine , Stanford University , Palo Alto , CA , USA.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Wurfel', 'Affiliation': 'c Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Washington , Seattle , WA , USA.'}, {'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Ware', 'Affiliation': 'd Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine , Vanderbilt University , Nashville , TN , USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Ruzinski', 'Affiliation': 'c Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Washington , Seattle , WA , USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Caldwell', 'Affiliation': 'c Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Washington , Seattle , WA , USA.'}, {'ForeName': 'Teal S', 'Initials': 'TS', 'LastName': 'Hallstrand', 'Affiliation': 'c Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Washington , Seattle , WA , USA.'}, {'ForeName': 'Polly E', 'Initials': 'PE', 'LastName': 'Parsons', 'Affiliation': 'a Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Vermont College of Medicine , Burlington , VT , USA.'}]","Biomarkers : biochemical indicators of exposure, response, and susceptibility to chemicals",['10.1080/1354750X.2019.1581840']
437,30822774,"Randomized, double-blind, placebo-controlled study of F17464, a preferential D 3 antagonist, in the treatment of acute exacerbation of schizophrenia.","F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.",2019,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","['acute exacerbation of schizophrenia', 'patients with acute exacerbation of schizophrenia']",['placebo'],"['weight gain, no extrapyramidal disorder except rare akathisia', 'insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective', 'PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria', 'adverse events (AEs', 'PANSS total score reduction', 'therapeutic efficacy', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015371', 'cui_str': 'Extrapyramidal Disorders'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0852908', 'cui_str': 'Drug ineffective'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",134.0,0.307203,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","[{'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa u.6, Budapest, 1083, Hungary.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York Presbyterian Hospital - Columbia University Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Gaudoux', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sokoloff', 'Affiliation': 'PSAdvice, Impasse Larosa, Ile-aux-Moines, 56780, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Groc', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': ""Galderma, Rue D'Entre-deux-Villes 10, La Tour de Peilz, 1814, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delsol', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Barthe', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Brunner', 'Affiliation': 'IRIS Servier, 50 rue Carot, Suresnes Cedex, 92284, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Fagard', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Tonner', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France. francoise.tonner@pierre-fabre.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0355-2']
438,32279919,Impact of left ventricular assist device implantation on mitral regurgitation: An analysis from the MOMENTUM 3 trial.,"BACKGROUND
Mitral regurgitation (MR) determines pathophysiology and outcome in advanced heart failure. The impact of left ventricular assist device (LVAD) placement on clinically significant MR and its contribution to long-term outcomes has been sparsely evaluated.
METHODS
We evaluated the effect of clinically significant MR on patients implanted in the MOMENTUM 3 trial with either the HeartMate II (HMII) or the HeartMate 3 (HM3) at 2 years. Clinical significance was defined as moderate or severe grade MR determined by site-based echocardiograms.
RESULTS
Of 927 patients with LVAD implants without a prior or concomitant mitral valve procedure, 403 (43.5%) had clinically significant MR at baseline. At 1-month of support, residual MR was present in 6.2% of patients with HM3 and 14.3% of patients with HMII (relative risk = 0.43; 95% CI, 0.22-0.84; p = 0.01) with a low rate of worsening at 2 years. Residual MR at 1-month post-implant did not impact 2-year mortality for either the HM3 (hazard ratio [HR],1.41; 95% CI, 0.52-3.89; p = 0.50) or HMII (HR, 0.91; 95% CI, 0.37-2.26; p = 0.84) LVAD. The presence or absence of baseline MR did not influence mortality (HM3 HR, 0.86; 95% CI, 0.56-1.33; p = 0.50; HMII HR, 0.81; 95% CI, 0.54-1.22; p = 0.32), major adverse events or functional capacity. In multivariate analysis, severe baseline MR (p = 0.001), larger left ventricular dimension (p = 0.002), and implantation with the HMII instead of the HM3 LVAD (p = 0.05) were independently associated with an increased likelihood of persistent MR post-implant.
CONCLUSIONS
Hemodynamic unloading after LVAD implantation improves clinically significant MR early, sustainably, and to a greater extent with the HM3 LVAD. Neither baseline nor residual MR influence outcomes after LVAD implantation.",2020,"Residual MR at 1-month post-implant did not impact 2-year mortality for either the HM3 (hazard ratio [HR],1.41; 95% CI, 0.52-3.89; p = 0.50) or HMII (HR, 0.91; 95% CI, 0.37-2.26; p = 0.84) LVAD.","['advanced heart failure', '927 patients with LVAD implants', 'mitral regurgitation']","['left ventricular assist device implantation', 'LVAD implantation', 'left ventricular assist device (LVAD) placement']","['larger left ventricular dimension', 'severe baseline MR', 'residual MR', 'major adverse events or functional capacity', 'Residual MR', 'moderate or severe grade MR']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",927.0,0.19855,"Residual MR at 1-month post-implant did not impact 2-year mortality for either the HM3 (hazard ratio [HR],1.41; 95% CI, 0.52-3.89; p = 0.50) or HMII (HR, 0.91; 95% CI, 0.37-2.26; p = 0.84) LVAD.","[{'ForeName': 'Manreet K', 'Initials': 'MK', 'LastName': 'Kanwar', 'Affiliation': 'Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Keshava', 'Initials': 'K', 'LastName': 'Rajagopal', 'Affiliation': ""The University of Texas Health Science Center at Houston and Memorial Hermann Hospital's Heart & Vascular Institute, Houston, Texas.""}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Itoh', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Silvestry', 'Affiliation': 'AdventHealth Transplant Institute, Orlando, Florida.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cleveland', 'Affiliation': 'University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Salerno', 'Affiliation': 'St Vincent Heart Center, Indianapolis, Indiana.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Horstmanshof', 'Affiliation': 'INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Montefiore Einstein Center for Heart and Vascular Care, New York, New York.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Naka', 'Affiliation': 'Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Igor D', 'Initials': 'ID', 'LastName': 'Gregoric', 'Affiliation': ""The University of Texas Health Science Center at Houston and Memorial Hermann Hospital's Heart & Vascular Institute, Houston, Texas.""}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Chuang', 'Affiliation': 'Abbott, Abbott Park, Illinois.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Abbott, Abbott Park, Illinois.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts. Electronic address: mmehra@bwh.harvard.edu.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.03.003']
439,32105353,Impact and Lessons From the Lifestyle Interventions and Independence for Elders (LIFE) Clinical Trials of Physical Activity to Prevent Mobility Disability.,"BACKGROUND
Walking independently is basic to human functioning. The Lifestyle Interventions and Independence for Elders (LIFE) studies were developed to assess whether initiating physical activity could prevent major mobility disability (MMD) in sedentary older adults.
METHODS
We review the development and selected findings of the LIFE studies from 2000 through 2019, including the planning phase, the LIFE-Pilot Study, and the LIFE Study.
RESULTS
The planning phase and the LIFE-Pilot provided key information for the successful implementation of the LIFE Study. The LIFE Study, involving 1635 participants randomized at eight sites throughout the United States, showed that compared with health education, the physical activity program reduced the risk of the primary outcome of MMD (inability to walk 400 m: hazard ratio = 0.82; 95% confidence interval = 0.69-0.98; P = .03), and that the intervention was cost-effective. There were no significant effects on cognitive outcomes, cardiovascular events, or serious fall injuries. In addition, the LIFE studies provided relevant findings on a broad range of other outcomes, including health, frailty, behavioral outcomes, biomarkers, and imaging. To date, the LIFE studies have generated a legacy of 109 peer-reviewed publications, 19 ancillary studies, and 38 independently funded grants and clinical trials, and advanced the development of 59 early career scientists. Data and biological samples of the LIFE Study are now publicly available from a repository sponsored by the National Institute on Aging (https://agingresearchbiobank.nia.nih.gov).
CONCLUSIONS
The LIFE studies generated a wealth of important scientific findings and accelerated research in geriatrics and gerontology, benefiting the research community, trainees, clinicians, policy makers, and the general public. J Am Geriatr Soc 68:872-881, 2020.",2020,"There were no significant effects on cognitive outcomes, cardiovascular events, or serious fall injuries.","['sedentary older adults', 'Elders (LIFE', '109 peer-reviewed publications, 19 ancillary studies, and 38 independently funded grants and clinical trials, and advanced the development of 59 early career scientists']",[],"['health, frailty, behavioral outcomes, biomarkers, and imaging', 'cost-effective', 'major mobility disability (MMD', 'cognitive outcomes, cardiovascular events, or serious fall injuries', 'Mobility Disability']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0030768', 'cui_str': 'Peer Review'}, {'cui': 'C0034036', 'cui_str': 'Publications'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0402112', 'cui_str': 'Scientist (occupation)'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1301836', 'cui_str': 'Falling injury (disorder)'}]",1635.0,0.0923591,"There were no significant effects on cognitive outcomes, cardiovascular events, or serious fall injuries.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Guralnik', 'Affiliation': 'Division of Gerontology, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Blair', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': 'ACAP Health Consulting, Dallas, Texas.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Groessl', 'Affiliation': 'VA San Diego Healthcare System and Department of Family and Preventive Medicine, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Health Research and Policy (Epidemiology) and of Medicine (Stanford Prevention Research Center), Stanford University, School of Medicine, Stanford, California.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': ""Department of Internal Medicine and the Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.""}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""Department of Internal Medicine and the Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.""}]",Journal of the American Geriatrics Society,['10.1111/jgs.16365']
440,32194148,Prior event rate ratio adjustment produced estimates consistent with randomized trial: a diabetes case study.,"OBJECTIVES
Electronic health records (EHR) provide a valuable resource for assessing drug side-effects, but treatments are not randomly allocated in routine care creating the potential for bias. We conduct a case study using the Prior Event Rate Ratio (PERR) Pairwise method to reduce unmeasured confounding bias in side-effect estimates for two second-line therapies for type 2 diabetes, thiazolidinediones, and sulfonylureas.
STUDY DESIGN AND SETTINGS
Primary care data were extracted from the Clinical Practice Research Datalink (n = 41,871). We utilized outcomes from the period when patients took first-line metformin to adjust for unmeasured confounding. Estimates for known side-effects and a negative control outcome were compared with the A Diabetes Outcome Progression Trial (ADOPT) trial (n = 2,545).
RESULTS
When on metformin, patients later prescribed thiazolidinediones had greater risks of edema, HR 95% CI 1.38 (1.13, 1.68) and gastrointestinal side-effects (GI) 1.47 (1.28, 1.68), suggesting the presence of unmeasured confounding. Conventional Cox regression overestimated the risk of edema on thiazolidinediones and identified a false association with GI. The PERR Pairwise estimates were consistent with ADOPT: 1.43 (1.10, 1.83) vs. 1.39 (1.04, 1.86), respectively, for edema, and 0.91 (0.79, 1.05) vs. 0.94 (0.80, 1.10) for GI.
CONCLUSION
The PERR Pairwise approach offers potential for enhancing postmarketing surveillance of side-effects from EHRs but requires careful consideration of assumptions.",2020,"When on metformin, patients later prescribed thiazolidinediones had greater risks of oedema, HR 95%CI 1.38 (1.13,1.68) and gastrointestinal (GI) side-effects 1.47 (1.28,1.68), suggesting the presence of unmeasured confounding.",[],"['metformin', 'ADOPT']","['risks of oedema, HR 95%CI', 'Prior Event Rate Ratio (PERR']",[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1842073', 'cui_str': 'Prolonged Electroretinal Response Suppression'}]",,0.0505379,"When on metformin, patients later prescribed thiazolidinediones had greater risks of oedema, HR 95%CI 1.38 (1.13,1.68) and gastrointestinal (GI) side-effects 1.47 (1.28,1.68), suggesting the presence of unmeasured confounding.","[{'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Rodgers', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK. Electronic address: L.R.Rodgers@exeter.ac.uk.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Dennis', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Beverley M', 'Initials': 'BM', 'LastName': 'Shields', 'Affiliation': 'NIHR Exeter Clinical Research Facility, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Mounce', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fisher', 'Affiliation': 'IQVIA, London UK.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Henley', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.03.007']
441,32278779,"Association of Guideline-Recommended COPD Inhaler Regimens With Mortality, Respiratory Exacerbations, and Quality of Life: A Secondary Analysis of the Long-Term Oxygen Treatment Trial.","BACKGROUND
Although inhaled therapy reduces exacerbations among patients with COPD, the effectiveness of providing inhaled treatment per risk stratification models remains unclear.
RESEARCH QUESTION
Are inhaled regimens that align with the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy associated with clinically important outcomes?
STUDY DESIGN AND METHODS
We conducted secondary analyses of Long-term Oxygen Treatment Trial (LOTT) data. The trial enrolled patients with COPD with moderate resting or exertional hypoxemia between 2009 and 2015. Our exposure was the patient-reported inhaled regimen at enrollment, categorized as either aligning with, undertreating, or potentially overtreating per the 2017 GOLD strategy. Our primary composite outcome was time to death or first hospitalization for COPD. Additional outcomes included individual components of the composite outcome and time to first exacerbation. We generated multivariable Cox proportional hazard models across strata of GOLD-predicted exacerbation risk (high vs low) to estimate between-group hazard ratios for time to event outcomes. We adjusted models a priori for potential confounders, clustered by site.
RESULTS
The trial enrolled 738 patients (73.4% men; mean age, 68.8 years). Of the patients, 571 (77.4%) were low risk for future exacerbations. Of the patients, 233 (31.6%) reported regimens aligning with GOLD recommendations; most regimens (54.1%) potentially overtreated. During a 2.3-year median follow-up, 332 patients (44.9%) experienced the composite outcome. We found no difference in time to composite outcome or death among patients reporting regimens aligning with recommendations compared with undertreated patients. Among patients at low risk, potential overtreatment was associated with higher exacerbation risk (hazard ratio, 1.42; 95% CI, 1.09-1.87), whereas inhaled corticosteroid treatment was associated with 64% higher risk of pneumonia (incidence rate ratio, 1.64; 95% CI, 1.01-2.66).
INTERPRETATION
Among patients with COPD with moderate hypoxemia, we found no difference in clinical outcomes between inhaled regimens aligning with the 2017 GOLD strategy compared with those that were undertreated. These findings suggest the need to reevaluate the effectiveness of risk stratification model-based inhaled treatment strategies.",2020,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"['COPD patients with moderate hypoxemia', 'enrolled COPD patients with moderate resting or exertional hypoxemia between 2009-2015', 'and Methods', 'COPD patients', '571 patients (77.4%) were low-risk for future exacerbations', '738 patients; 73.4% were male with mean age 68.8 years']",[],"['individual components of the composite outcome and time-to first exacerbation', 'exacerbation risk', 'COPD Inhaler Regimenswith Mortality, Respiratory Exacerbations, and Quality of Life', 'risk of pneumonia', 'time-to composite outcome or death', 'time-to death or first hospitalization for COPD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",738.0,0.234867,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA. Electronic address: tlk33@uw.edu.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Spece', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Donovan', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Coggeshall', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Bryant', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'J Allen', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'Birmingham VA Medical Center and the Lung Health Center, University of Alabama Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Temple University School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Phillip T', 'Initials': 'PT', 'LastName': 'Diaz', 'Affiliation': '201 Heart Lung Institute, Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Fuhlbrigge', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gay', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, MI.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Kanner', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Panos', 'Affiliation': 'Cincinnati VA Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shade', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sternberg', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stibolt', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Stoller', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Yusen', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Feemster', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}]",Chest,['10.1016/j.chest.2020.02.073']
442,30037818,"Randomized Phase II Study Evaluating Akt Blockade with Ipatasertib, in Combination with Abiraterone, in Patients with Metastatic Prostate Cancer with and without PTEN Loss.","PURPOSE
PI3K-Akt-mTOR and androgen receptor (AR) signaling are commonly aberrantly activated in metastatic castration-resistant prostate cancer (mCRPC), with PTEN loss associating with poor prognosis. We therefore conducted a phase Ib/II study of the combination of ipatasertib, an Akt inhibitor, with the CYP17 inhibitor abiraterone in patients with mCRPC. Patients and Methods: Patients were randomized 1:1:1 to ipatasertib 400 mg, ipatasertib 200 mg, or placebo, with abiraterone 1,000 mg orally. Coprimary efficacy endpoints were radiographic progression-free survival (rPFS) in the intent-to-treat population and in patients with PTEN-loss tumors.
RESULTS
rPFS was prolonged in the ipatasertib cohort versus placebo, with similar trends in overall survival and time-to-PSA progression. A larger rPFS prolongation for the combination was demonstrated in PTEN-loss tumors versus those without. The combination was well tolerated, with no treatment-related deaths.
CONCLUSIONS
In mCRPC, combined blockade with abiraterone and ipatasertib showed superior antitumor activity to abiraterone alone, especially in patients with PTEN-loss tumors. See related commentary by Zhang et al., p. 901 .",2019,"The combination was well tolerated, with no treatment-related deaths.
","['patients with PTEN-loss tumors', 'patients with mCRPC', 'Patients with Metastatic Prostate Cancer with and without PTEN Loss']","['ipatasertib 400 mg, ipatasertib 200 mg, or placebo, with abiraterone 1,000 mg orally', 'CYP17 inhibitor abiraterone', 'Abiraterone', 'placebo']","['rPFS prolongation', 'superior antitumor activity', 'overall survival and time-to-PSA progression', 'radiographic progression-free survival (rPFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0038302', 'cui_str': 'Cytochrome P-450(17 alpha)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0575214,"The combination was well tolerated, with no treatment-related deaths.
","[{'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'The Royal Marsden/Institute of Cancer Research, London, United Kingdom. Johann.DeBono@icr.ac.uk.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Daniel Nava', 'Initials': 'DN', 'LastName': 'Rodrigues', 'Affiliation': 'The Royal Marsden/Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Massard', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Medical Oncology, Ospedale San Donato, Azienda USL Toscana Sud-Est, Istituto Toscano Tumori, Arezzo, Italy.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Font', 'Affiliation': ""Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Jose Angel', 'Initials': 'JA', 'LastName': 'Arranz Arija', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Kent C', 'Initials': 'KC', 'LastName': 'Shih', 'Affiliation': 'Tennessee Oncology, Nashville, Tennessee.'}, {'ForeName': 'George Daniel', 'Initials': 'GD', 'LastName': 'Radavoi', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Wai Y', 'Initials': 'WY', 'LastName': 'Chan', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gendreau', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Riisnaes', 'Affiliation': 'The Royal Marsden/Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Premal H', 'Initials': 'PH', 'LastName': 'Patel', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Maslyar', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Viorel', 'Initials': 'V', 'LastName': 'Jinga', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-0981']
443,32279518,A 12-hour comprehensive nutrition care benefits blood glucose level and weight gain and improves outcomes in pregnant women with gestational diabetes mellitus.,"BACKGROUND
Gestational diabetes mellitus (GDM) is associated with adverse outcomes and neonatal complications. Its prevalence has been rapidly increasing over the last decade; it is estimated that one in six pregnant women are diagnosed with GDM. Thus, an effective management approach is necessary for women with GDM. This study investigated the effect of a 12-h comprehensive nutrition care (12h-HNC) on the metabolism and outcomes of pregnant women with GDM and neonatal birth weight and hypoglycemia.
METHODS
The study included 312 pregnant women with GDM at 24-28 weeks of gestation who were treated in our department from January 2014 to December 2016. They were randomly assigned to receive a 12h-HNC (12h-HNC group, n=158) or traditional one-time nutrition guidance (control group, n=154). Maternal blood glucose levels and weight gain, as well as maternal and neonatal outcomes were evaluated and compared between the groups.
RESULTS
Compared to those in the control group, patients in the 12h-HNC group had significantly lower 2-h postprandial glucose levels (P<0.05), lower average weight increase (P<0.05), and better outcomes (P<0.05). Neonatal birth weight and incidence of macrosomia were significantly lower in the 12h-HNC group. The incidence of cesarean section was similar in the two groups (P>0.05).
CONCLUSIONS
The 12h-HNC enabled better blood glucose and weight increase control, improving both maternal and neonatal outcomes in women with GDM. This comprehensive nutrition intervention may achieve favorable effects in clinical practice.",2020,"The 12h-HNC enabled better blood glucose and weight increase control, improving both maternal and neonatal outcomes in women with GDM.","['pregnant women with GDM and neonatal birth weight and hypoglycemia', 'Gestational diabetes mellitus (GDM', 'pregnant women with gestational diabetes mellitus', 'six pregnant women are diagnosed with GDM', 'women with GDM', '312 pregnant women with GDM at 24-28 weeks of gestation who were treated in our department from January 2014 to December 2016']","['12h-HNC (12h-HNC group, n=158) or traditional one-time nutrition guidance (control', 'comprehensive nutrition care (12h-HNC']","['blood glucose and weight increase control, improving both maternal and neonatal outcomes', 'Neonatal birth weight and incidence of macrosomia', 'Maternal blood glucose levels and weight gain, as well as maternal and neonatal outcomes', 'incidence of cesarean section', 'average weight increase', '2-h postprandial glucose levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1258068', 'cui_str': 'Nutrition management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",312.0,0.0273275,"The 12h-HNC enabled better blood glucose and weight increase control, improving both maternal and neonatal outcomes in women with GDM.","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yuan', 'Affiliation': 'Nursing Department, The Fourth Hospital of Shijiazhuang, Shijiazhuang 050011, China.'}, {'ForeName': 'Haoyuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'School of Basic Medical Sciences, Hebei Medical University, Shijiazhuang 050017, China.'}, {'ForeName': 'Yujia', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Basic Medical Sciences, Hebei Medical University, Shijiazhuang 050017, China.'}, {'ForeName': 'Sijie', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'School of Basic Medical Sciences, Hebei Medical University, Shijiazhuang 050017, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, The First Hospital of Hebei Medical University, Shijiazhuang 050000, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Emergency Department, The Fourth Hospital of Shijiazhuang, Shijiazhuang 050011, China.'}, {'ForeName': 'Shuqing', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Nutrition, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Medical Record Department, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Nutrition, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China. w1420174542@126.com.'}]",Annals of palliative medicine,['10.21037/apm.2020.03.16']
444,32276098,Phase 3 Study of Palonosetron IV Infusion Vs. IV Bolus for Chemotherapy-Induced Nausea and Vomiting Prophylaxis After Highly Emetogenic Chemotherapy.,"CONTEXT
Palonosetron (PALO) is one of the two active components of NEPA, the fixed-combination antiemetic comprising netupitant (oral)/fosnetupitant (IV) and PALO. To increase the convenience of NEPA administration, especially for patients with swallowing difficulties, an IV NEPA formulation has been developed, where PALO is administered as a 30-minute infusion instead of the approved 30-second bolus.
OBJECTIVES
To determine the efficacy and safety of the PALO component used in IV NEPA.
METHODS
Noninferiority, double-blind, and randomized Phase 3 trial in chemotherapy-naive adult patients with cancer requiring highly emetogenic chemotherapy. Patients were randomized to receive a single dose of PALO 0.25 mg administered IV either as a 30-minute infusion or as a 30-second bolus before highly emetogenic chemotherapy. The primary objective was to demonstrate noninferiority of the 30-minute infusion vs. 30-second bolus in terms of complete response (CR; no emesis and no rescue medication) in the acute phase. Secondary efficacy endpoints were CR in the delayed and overall phases and no emesis and no rescue medication in all phases. Safety was a secondary endpoint.
RESULTS
Overall, 440 patients received study treatment. In the infusion group, 186 (82.7%) patients reported CR in the acute phase vs. 186 (86.5%) patients in the bolus group, demonstrating the noninferiority of PALO infusion vs. bolus (P < 0.001). Secondary endpoints showed similar results between the two treatment groups.
CONCLUSION
PALO 0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase. These results support the use of PALO 0.25 mg as a component of IV NEPA.",2020,0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase.,"['naive adult cancer patients requiring highly emetogenic chemotherapy (HEC', '440 patients received study treatment', 'patients with swallowing difficulties']","['chemotherapy', 'palonosetron intravenous (IV) infusion versus IV bolus for chemotherapy', 'PALO']","['CR in the delayed and overall phases, and no emesis and no rescue medication', 'complete response (CR; no emesis, no rescue medication', 'nausea and vomiting prophylaxis', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.119251,0.25-mg 30-minute IV infusion was noninferior to 30-second IV bolus in terms of CR rate in the acute phase.,"[{'ForeName': 'Meinolf', 'Initials': 'M', 'LastName': 'Karthaus', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Neuperlach/Klinikum Harlaching, Munich, Germany. Electronic address: meinolf.karthaus@klinikum-muenchen.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Voisin', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland; Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Ciuleanu', 'Affiliation': 'Institute of Oncology Prof. Dr. Ion Chiricuţã and UMF Iuliu Haţieganu, Cluj-Napoca, Romania.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.03.034']
445,30144099,"Effects of a State- and Use-Dependent Nav1.7 Channel Blocker on Ambulatory Blood Pressure: A Randomized, Controlled Crossover Study.","Vixotrigine is a state- and use-dependent Nav1.7 channel blocker being investigated for the treatment of neuropathic pain conditions. This randomized, double-blind, placebo-controlled crossover trial was designed to evaluate changes in blood pressure with the administration of vixotrigine using ambulatory blood pressure monitoring (ABPM). Eligible participants were healthy adults 18 to 65 years of age without evidence of baseline systolic blood pressure (SBP) persistently > 140 mm Hg or diastolic blood pressure (DBP) persistently > 90 mm Hg. Vixotrigine (400 mg [men], 300 mg [women]) or placebo was administered orally twice daily for 36 days. Following a 7-day washout period, participants crossed over to the other treatment. Each dosing period was preceded by 1 inpatient visit and 1 outpatient baseline visit. Two 14-hour inpatient ABPM sessions occurred on days 14 and 35, with a return to the clinic the morning of days 15 and 36 for initiation of outpatient ABPM, which assessed blood pressure and heart rate every 15 minutes. Adverse events were collected throughout the study. The primary end point was the change from baseline in 24-hour mean SBP and DBP on day 36. Sixty participants were enrolled; 10 withdrew from the study owing to adverse events, investigator discretion, or withdrawal of consent. From baseline to day 36, mean changes in average SBP and DBP (vixotrigine treated) were -0.33 and 0.20 mm Hg, respectively. Adverse event rates were comparable for vixotrigine and placebo; the most common adverse events were headache, dizziness, and nausea. Vixotrigine administration is not associated with a clinically important increase in blood pressure.",2019,Vixotrigine administration is not associated with a clinically important increase in blood pressure.,"['Sixty participants were enrolled; 10 withdrew from the study owing to adverse events, investigator discretion, or withdrawal of consent', 'Eligible participants were healthy adults 18 to 65\xa0years of age without evidence of baseline systolic blood pressure (SBP) persistently ']","['State- and Use-Dependent Nav1.7 Channel Blocker', 'placebo', 'vixotrigine using ambulatory blood pressure monitoring (ABPM', 'channel blocker', 'Vixotrigine']","['diastolic blood pressure (DBP', 'Adverse events', 'blood pressure', 'blood pressure and heart rate', 'average SBP and DBP', '24-hour mean SBP and DBP', 'Ambulatory Blood Pressure', 'Adverse event rates', 'headache, dizziness, and nausea']","[{'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",60.0,0.290932,Vixotrigine administration is not associated with a clinically important increase in blood pressure.,"[{'ForeName': 'Regan', 'Initials': 'R', 'LastName': 'Fong', 'Affiliation': 'Immunovant, Inc., Durham, NC, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Ballow', 'Affiliation': 'Buffalo Clinical Research Center, LLC, Buffalo, NY, USA.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Naik', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Deb', 'Initials': 'D', 'LastName': 'Steiner', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Freelance Clinical Scientist, Oakham, UK.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1298']
446,32279184,Educational Video Addition to the Bariatric Surgery Informed Consent Process: a Randomized Controlled Trial.,"OBJECTIVE
Bariatric surgery is not a risk-free procedure and requires lifelong patient compliance in the postoperative period. Although the risks involved in bariatric surgery and the importance of lifelong follow-ups in the postoperative period are explained to patients in detail through verbal and written informed consent, the strong desire for weight loss can sometimes cause patients and their families to be ignorant of the mentioned issues preoperatively. The objective of this study is to evaluate the effectiveness of preoperative informational videos at improving the comprehension of informed consent content in bariatric surgery candidates.
MATERIALS AND METHODS
A total of 74 bariatric surgery candidates were randomized into two groups. The first group was given a usual verbal-written informed consent. The second group got an additional informing video presentation informed consent, in addition to the usual verbal-written informed consent. Then, both groups got a questionnaire evaluating their knowledge of bariatric surgery informed consent. The correct response scores and their relationship with patient demographics were analyzed.
RESULTS
Both groups had similar demographic features. Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001). Subgroup analysis showed that health care workers (12.5 ± 1.9 versus 10.3 ± 2.2, p = 0.005) and university graduates (11.6 ± 2.4 versus 10.1 ± 2.1, p = 0.03) got better results in the questionnaire. In multivariate analysis, video-assisted informing was found to be the only independent variable for high questionnaire scores (p = 0.0001).
CONCLUSIONS
This study showed that video-assisted informed consent improves patients' comprehension prior to bariatric surgery. We recommend routine preoperative video-assisted informing for bariatric surgery candidates in addition to usual verbal-written informed consent.",2020,"Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001).","['74 bariatric surgery candidates', ""patients' comprehension prior to bariatric surgery""]","['usual verbal-written informed consent', 'additional informing video presentation informed consent, in addition to the usual verbal-written informed consent', 'video-assisted informed consent', 'preoperative informational videos']","['health care workers', 'high questionnaire scores']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.0360758,"Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001).","[{'ForeName': 'Kutay', 'Initials': 'K', 'LastName': 'Saglam', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey. saglamk@gmail.com.'}, {'ForeName': 'Cuneyt', 'Initials': 'C', 'LastName': 'Kayaalp', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey.'}, {'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Aktas', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Sumer', 'Affiliation': 'Department of Gastrointestinal Surgery, Inonu University, 44315, Malatya, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04552-x']
447,32276980,A Mediterranean Diet Intervention Reduces the Levels of Salivary Periodontopathogenic Bacteria in Overweight and Obese Subjects.,"The human oral cavity is a complex ecosystem, and the alterations in salivary microbial communities are associated with both oral and nonoral diseases. The Mediterranean diet (MD) is a healthy dietary pattern useful for both prevention and treatment of several diseases. To further explore the effects of the MD on human health, in this study, we investigated the changes in the salivary microbial communities in overweight/obese subjects after an individually tailored MD-based nutritional intervention. Healthy overweight and obese subjects were randomized between two intervention groups. The MD group (Med-D group) increased their MD adherence during 8 weeks of intervention while the control diet (control-D) group did not change their dietary habits. The salivary microbiota was assessed at baseline and after 4 and 8 weeks of intervention. Despite no observed changes in the overall salivary microbiota composition, we found a significant decrease in the relative abundances of species-level operational taxonomic units annotated as Porphyromonas gingivalis , Prevotella intermedia , and Treponema denticola in the Med-D group compared to that in the control-D group after 8 weeks of intervention, which are known to be associated with periodontal disease. Such variations were significantly linked to dietary variables such as MD adherence rates and intakes of animal versus vegetable proteins. In addition, increased levels of Streptococcus cristatus were observed in the Med-D group, which has been reported as an antagonistic taxon inhibiting P. gingivalis gene expression. Our findings suggest that an MD-based nutritional intervention may be implicated in reducing periodontal bacteria, and an MD may be a dietary strategy supportive of oral homeostasis. IMPORTANCE Changes in dietary behavior with increased adherence to a Mediterranean diet can determine a reduction of periodontopathogenic bacterial abundances in the saliva of overweight subjects with cardiometabolic risk due to an unhealthy lifestyle, without any change in individual energy intake, nutrient intake, and physical activity.",2020,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"['overweight and obese subjects', 'Healthy overweight and obese subjects', 'overweight/obese subjects after an individually tailored MD-based nutritional intervention']","['Mediterranean diet intervention', 'Mediterranean diet (MD', 'MD']","['salivary microbiota', 'overall salivary microbiota composition', 'salivary periodontopathogenic bacteria', 'levels of Streptococcus cristatus', 'MD adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0318141', 'cui_str': 'Streptococcus cristatus'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0139182,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"[{'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Laiola', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Filippis', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Ercolini', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy ercolini@unina.it.'}]",Applied and environmental microbiology,['10.1128/AEM.00777-20']
448,31604814,Closed-Loop Acoustic Stimulation Enhances Sleep Oscillations But Not Memory Performance.,"Slow oscillations and spindle activity during non-rapid eye movement sleep have been implicated in memory consolidation. Closed-loop acoustic stimulation has previously been shown to enhance slow oscillations and spindle activity during sleep and improve verbal associative memory. We assessed the effect of closed-loop acoustic stimulation during a daytime nap on a virtual reality spatial navigation task in 12 healthy human subjects in a randomized within-subject crossover design. We show robust enhancement of slow oscillation and spindle activity during sleep. However, no effects on behavioral performance were observed when comparing real versus sham stimulation. To explore whether memory enhancement effects were task specific and dependent on nocturnal sleep, in a second experiment with 19 healthy subjects, we aimed to replicate a previous study that used closed-loop acoustic stimulation to enhance memory for word pairs. The methods used were as close as possible to those used in the original study, except that we used a double-blind protocol, in which both subject and experimenter were unaware of the test condition. Again, we successfully enhanced slow oscillation and spindle power, but again did not strengthen associative memory performance with stimulation. We conclude that enhancement of sleep oscillations may be insufficient to enhance memory performance in spatial navigation or verbal association tasks, and provide possible explanations for lack of behavioral replication.",2019,Closed-loop acoustic stimulation has previously been shown to enhance slow oscillations and spindle activity during sleep and improve verbal associative memory.,"['19 healthy subjects', '12 healthy human subjects']","['Closed-loop acoustic stimulation', 'closed-loop acoustic stimulation']","['verbal associative memory', 'verbal memory performance', 'behavioral performance', 'memory performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}]",12.0,0.199326,Closed-loop acoustic stimulation has previously been shown to enhance slow oscillations and spindle activity during sleep and improve verbal associative memory.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Henin', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016 Anli.liu@nyulangone.org simon.henin@nyulangone.org.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Borges', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shankar', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Cansu', 'Initials': 'C', 'LastName': 'Sarac', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Melloni', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Friedman', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Adeen', 'Initials': 'A', 'LastName': 'Flinker', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Parra', 'Affiliation': 'Department of Biomedical Engineering, City College of New York, New York, New York 10031.'}, {'ForeName': 'Gyorgy', 'Initials': 'G', 'LastName': 'Buzsaki', 'Affiliation': 'New York University Langone Health, New York, NY 10016.'}, {'ForeName': 'Orrin', 'Initials': 'O', 'LastName': 'Devinsky', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016.'}, {'ForeName': 'Anli', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'NYU Comprehensive Epilepsy Center, New York, New York 10016 Anli.liu@nyulangone.org simon.henin@nyulangone.org.'}]",eNeuro,['10.1523/ENEURO.0306-19.2019']
449,32276257,Biomechanical analysis of occipitocervical stabilization techniques: emphasis on integrity of osseous structures at the occipital implantation sites.,"OBJECTIVE
The objective of the current study was to quantify and compare the multidirectional flexibility properties of occipital anchor fixation with conventional methods of occipitocervical screw fixation using nondestructive and destructive investigative methods.
METHODS
Fourteen cadaveric occipitocervical specimens (Oc-T2) were randomized to reconstruction with occipital anchors or an occipital plate and screws. Using a 6-degree-of-freedom spine simulator with moments of ± 2.0 Nm, initial multidirectional flexibility analysis of the intact and reconstructed conditions was performed followed by fatigue loading of 25,000 cycles of flexion-extension (x-axis, ± 2.0 Nm), 15,000 cycles of lateral bending (z-axis, ± 2.0 Nm), and 10,000 cycles of axial rotation (y-axis, ± 2.0 Nm). Fluoroscopic images of the implantation sites were obtained before and after fatigue testing and placed on an x-y coordinate system to quantify positional stability of the anchors and screws used for reconstruction and effect, if any, of the fatigue component. Destructive testing included an anterior flexural load to construct failure. Quantification of implant, occipitocervical, and atlantoaxial junction range of motion is reported as absolute values, and peak flexural failure moment in Newton-meters (Nm).
RESULTS
Absolute value comparisons between the intact condition and 2 reconstruction groups demonstrated significant reductions in segmental flexion-extension, lateral bending, and axial rotation motion at the Oc-C1 and C1-2 junctions (p < 0.05). The average bone mineral density at the midline keel (1.422 g/cm3) was significantly higher compared with the lateral occipital region at 0.671 g/cm3 (p < 0.05). There were no significant differences between the occipital anchor and plate treatments in terms of angular rotation (degrees; p = 0.150) or x-axis displacement (mm; p = 0.572), but there was a statistically significant difference in y-axis displacement (p = 0.031) based on quantitative analysis of the pre- and postfatigue fluoroscopic images (p > 0.05). Under destructive anterior flexural loading, the occipital anchor group failed at 90 ± 31 Nm, and the occipital plate group failed at 79 ± 25 Nm (p > 0.05).
CONCLUSIONS
Both reconstructions reduced flexion-extension, lateral bending, and axial rotation at the occipitocervical and atlantoaxial junctions, as expected. Flexural load to failure did not differ significantly between the 2 treatment groups despite occipital anchors using a compression-fit mechanism to provide fixation in less dense bone. These data suggest that an occipital anchor technique serves as a biomechanically viable clinical alternative to occipital plate fixation.",2020,Flexural load to failure did not differ significantly between the 2 treatment groups despite occipital anchors using a compression-fit mechanism to provide fixation in less dense bone.,['Fourteen cadaveric occipitocervical specimens (Oc-T2'],"['occipitocervical screw fixation', 'reconstruction with occipital anchors or an occipital plate and screws']","['Quantification of implant, occipitocervical, and atlantoaxial junction range of motion', 'angular rotation', 'Flexural load to failure', 'flexion-extension, lateral bending, and axial rotation at the occipitocervical and atlantoaxial junctions', 'average bone mineral density', 'y-axis displacement', 'segmental flexion-extension, lateral bending, and axial rotation motion']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0450192', 'cui_str': 'Atlantoaxial'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0439748', 'cui_str': 'Flexural'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",,0.0359906,Flexural load to failure did not differ significantly between the 2 treatment groups despite occipital anchors using a compression-fit mechanism to provide fixation in less dense bone.,"[{'ForeName': 'Bryan W', 'Initials': 'BW', 'LastName': 'Cunningham', 'Affiliation': '1Musculoskeletal Education Center, Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, Baltimore, Maryland.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Mueller', 'Affiliation': '2Department of Neurosurgery, Georgetown University Medical Center, Washington, DC; and.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Mullinix', 'Affiliation': '1Musculoskeletal Education Center, Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, Baltimore, Maryland.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': '3Department of Orthopaedic Surgery, Tianjin Hospital, Tianjin, China.'}, {'ForeName': 'Faheem A', 'Initials': 'FA', 'LastName': 'Sandhu', 'Affiliation': '2Department of Neurosurgery, Georgetown University Medical Center, Washington, DC; and.'}]",Journal of neurosurgery. Spine,['10.3171/2020.1.SPINE191331']
450,31591483,Role of appetitive phenotype trajectory groups on child body weight during a family-based treatment for children with overweight or obesity.,"OBJECTIVE
Emerging evidence suggests that individual appetitive traits may usefully explain patterns of weight loss in behavioral weight loss treatments for children. The objective of this study was to identify trajectories of child appetitive traits and the impact on child weight changes over time.
METHODS
Secondary data analyses of a randomized noninferiority trial conducted between 2011 and 2015 evaluated children's appetitive traits and weight loss. Children with overweight and obesity (mean age = 10.4; mean BMI z = 2.0; 67% girls; 32% Hispanic) and their parent (mean age = 42.9; mean BMI = 31.9; 87% women; 31% Hispanic) participated in weight loss programs and completed assessments at baseline, 3, 6,12, and 24 months. Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories. Linear mixed-effects models were used to identify the impact of group trajectory on child BMIz change over time.
RESULTS
One hundred fifty children and their parent enrolled in the study. The three-group trajectory model was the most parsimonious and included a high satiety responsive group (HighSR; 47.4%), a high food responsive group (HighFR; 34.6%), and a high emotional eating group (HighEE; 18.0%). Children in all trajectories lost weight at approximately the same rate during treatment, however, only the HighSR group maintained their weight loss during follow-ups, while the HighFR and HighEE groups regained weight (adjusted p-value < 0.05).
CONCLUSIONS
Distinct trajectories of child appetitive traits were associated with differential weight loss maintenance. Identified high-risk subgroups may suggest opportunities for targeted intervention and maintenance programs.",2019,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","['children', 'children with overweight or obesity', 'Children with overweight and obesity (mean age\u2009', 'One hundred fifty children and their parent enrolled in the study', ""2011 and 2015 evaluated children's appetitive traits and weight loss""]",['appetitive phenotype trajectory'],"['child body weight', 'differential weight loss maintenance', 'child BMIz change over time', 'weight loss', 'child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",150.0,0.0200187,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","[{'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA. kboutelle@ucsd.edu.'}, {'ForeName': 'D Eastern', 'Initials': 'DE', 'LastName': 'Kang Sim', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manzano', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, La Jolla, CA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0463-4']
451,31939785,"Family Care Rituals in the ICU to Reduce Symptoms of Post-Traumatic Stress Disorder in Family Members-A Multicenter, Multinational, Before-and-After Intervention Trial.","OBJECTIVES
To assess the feasibility and efficacy of implementing ""Family Care Rituals"" as a means of engaging family members in the care of patients admitted to the ICU with a high risk of ICU mortality on outcomes including stress-related symptoms in family members.
DESIGN
Prospective, before-and-after intervention evaluation.
SETTING
Two U.S. academic medical ICU's, and one Italian academic medical/surgical ICU.
SUBJECTS
Family members of patients who had an attending predicted ICU mortality of greater than 30% within the first 24 hours of admission.
INTERVENTIONS
A novel intervention titled ""Family Care Rituals"" during which, following a baseline observation period, family members enrolled in the intervention phase were given an informational booklet outlining opportunities for engagement in care of the patient during their ICU stay.
MEASUREMENTS AND MAIN RESULTS
Primary outcome was symptoms of post-traumatic stress disorder in family members 90 days after patient death or ICU discharge. Secondary outcomes included symptoms of depression, anxiety, and family satisfaction. At 90-day follow-up, 131 of 226 family members (58.0%) responded preintervention and 129 of 226 family members (57.1%) responded postintervention. Symptoms of post-traumatic stress disorder were significantly higher preintervention than postintervention (39.2% vs 27.1%; unadjusted odds ratio, 0.58; p = 0.046). There was no significant difference in symptoms of depression (26.5% vs 25.2%; unadjusted odds ratio, 0.93; p = 0.818), anxiety (41.0% vs 45.5%; unadjusted odds ratio, 1.20; p = 0.234), or mean satisfaction scores (85.1 vs 89.0; unadjusted odds ratio, 3.85; p = 0.052) preintervention versus postintervention 90 days after patient death or ICU discharge.
CONCLUSIONS
Offering opportunities such as family care rituals for family members to be involved with providing care for family members in the ICU was associated with reduced symptoms of post-traumatic stress disorder. This intervention may lessen the burden of stress-related symptoms in family members of ICU patients.",2020,"Symptoms of post-traumatic stress disorder were significantly higher preintervention than postintervention (39.2% vs 27.1%; unadjusted odds ratio, 0.58; p = 0.046).","[""Two U.S. academic medical ICU's, and one Italian academic medical/surgical ICU.\nSUBJECTS"", 'Family Members', 'family members of ICU patients', 'engaging family members in the care of patients admitted to the ICU with a high risk of ICU mortality on outcomes including stress-related symptoms in family members']","['implementing ""Family Care Rituals']","['symptoms of depression, anxiety, and family satisfaction', 'symptoms of depression', 'mean satisfaction scores', 'symptoms of post-traumatic stress disorder in family members 90 days after patient death or ICU discharge', 'ICU mortality', 'Symptoms of post-traumatic stress disorder', 'anxiety']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2945764', 'cui_str': 'Ritual (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0360186,"Symptoms of post-traumatic stress disorder were significantly higher preintervention than postintervention (39.2% vs 27.1%; unadjusted odds ratio, 0.58; p = 0.046).","[{'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Amass', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care & Sleep, Brown University, Providence, RI.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Villa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'OMahony', 'Affiliation': 'Department of Internal Medicine, Palliative Medicine Section, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Badger', 'Affiliation': 'Department of Psychiatry, Brown University, Providence, RI.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'McFadden', 'Affiliation': 'Department of Internal Medicine, Palliative Medicine Section, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Rhode Island Hospital, Research Division of Pulmonary, Critical Care & Sleep, Providence, RI.'}, {'ForeName': 'Tanis', 'Initials': 'T', 'LastName': 'Caine', 'Affiliation': 'Rhode Island Hospital, Research Division of Pulmonary, Critical Care & Sleep, Providence, RI.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'McGuirl', 'Affiliation': 'Rhode Island Hospital, Research Division of Pulmonary, Critical Care & Sleep, Providence, RI.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Palmisciano', 'Affiliation': 'Rhode Island Hospital, Research Division of Pulmonary, Critical Care & Sleep, Providence, RI.'}, {'ForeName': 'Mei-Ean', 'Initials': 'ME', 'LastName': 'Yeow', 'Affiliation': 'Center for Palliative Care, Mayo Clinic, Rochester, NY.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Gaudio', 'Affiliation': 'Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Mitchell M', 'Initials': 'MM', 'LastName': 'Levy', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care & Sleep, Brown University, Providence, RI.'}]",Critical care medicine,['10.1097/CCM.0000000000004113']
452,32086551,Neural responses in the pain matrix when observing pain of others are unaffected by testosterone administration in women.,"There is evidence of testosterone having deteriorating effects on cognitive and affective empathic behaviour in men and women under varying conditions. However, whether testosterone influences empathy for pain has not yet been investigated. Therefore, we tested neural responses to witnessing others in pain in a within-subject placebo-controlled testosterone administration study in healthy young women. Using functional magnetic resonance imaging, we provide affirming evidence that an empathy-inducing paradigm causes changes in the activity throughout the pain circuitry, including the bilateral insula and anterior cingulate cortex. Administration of testosterone, however, did not influence these activation patterns in the pain matrix. Testosterone has thus downregulating effects on aspects of empathic behaviour, but based on these data does not seem to influence neural responses during empathy for others' pain. This finding gives more insight into the role of testosterone in human empathy.",2020,There is evidence of testosterone having deteriorating effects on cognitive and affective empathic behaviour in men and women under varying conditions.,"['men and women under varying conditions', 'healthy young women']","['placebo-controlled testosterone', 'Testosterone', 'testosterone']",['cognitive and affective empathic behaviour'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]",[],,0.324285,There is evidence of testosterone having deteriorating effects on cognitive and affective empathic behaviour in men and women under varying conditions.,"[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Heany', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Terburg', 'Affiliation': 'Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'van Honk', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Bos', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, Leiden, The Netherlands. p.a.bos@fsw.leidenuniv.nl.'}]",Experimental brain research,['10.1007/s00221-020-05749-3']
453,32227755,Initial Invasive or Conservative Strategy for Stable Coronary Disease.,"BACKGROUND
Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain.
METHODS
We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction.
RESULTS
Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32).
CONCLUSIONS
Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","['patients with stable coronary disease and moderate or severe ischemia', 'Stable Coronary Disease', '5179 patients with moderate or severe ischemia to an']","['initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed', 'invasive intervention plus medical therapy']","['death from cardiovascular causes or myocardial infarction', 'risk of ischemic cardiovascular events or death', 'definition of myocardial infarction', 'procedural myocardial infarctions of uncertain clinical importance', 'composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'cumulative event rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",5179.0,0.217237,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'López-Sendón', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Ruzyllo', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mangalath N', 'Initials': 'MN', 'LastName': 'Krishnan', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Nagaraja', 'Initials': 'N', 'LastName': 'Moorthy', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Whady A', 'Initials': 'WA', 'LastName': 'Hueb', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Peteiro', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Miller', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szwed', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Doerr', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Kirby', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Neal O', 'Initials': 'NO', 'LastName': 'Jeffries', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'T Bruce', 'Initials': 'TB', 'LastName': 'Ferguson', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Williams', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915922']
454,32096852,Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening.,"Importance
Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.
Objective
To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Design, Setting, and Participants
Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
Exposures
All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
Main Outcomes and Measures
The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Results
Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).
Conclusions and Relevance
Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.
Trial Registration
ClinicalTrials.gov Identifier: NCT02933489.",2020,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","['Women With Dense Breasts Undergoing Screening', 'women with dense breasts', '17 women with invasive cancer and 2 of 6 women with DCIS', '1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis', 'Breast Cancer Detection', 'Participants\n\n\nCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening', '17 women with invasive cancer and 5 of 6 women with DCIS']","['abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT', 'Abbreviated Breast MRI vs Digital Breast Tomosynthesis']","['additional imaging recommendation rate', 'PPV', 'No interval cancers', 'sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS', 'invasive cancer detection rate', 'rate of invasive breast cancer detection', 'specificity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",1516.0,0.363375,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Comstock', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Newstead', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Snyder', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ilana F', 'Initials': 'IF', 'LastName': 'Gareen', 'Affiliation': 'Center for Statistical Sciences, Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Bergin', 'Affiliation': 'UW Cancer Center at ProHealth Care, Waukesha, Wisconsin.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Rahbar', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Sung', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'West Michigan Cancer Center, Kalamazoo.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Harvey', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Nicholson', 'Affiliation': 'Community Hospital, Munster, Indiana.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Ward', 'Affiliation': 'Rhode Island Hospital, Providence.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Holt', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prather', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Schnall', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christiane K', 'Initials': 'CK', 'LastName': 'Kuhl', 'Affiliation': 'University Hospital of RWTH Aachen, Aachen, Germany.'}]",JAMA,['10.1001/jama.2020.0572']
455,32268328,Effect of Lifestyle Interventions in Obese Pregnant Women on the Neurocognitive Development and Anthropometrics of Preschool Children.,"INTRODUCTION
Maternal obesity and excessive gestational weight gain are related to adverse outcomes in women and children. Lifestyle interventions during pregnancy showed positive effects on decreasing weight gain during pregnancy, but effects on offspring's health and wellbeing are unclear. We aimed to assess the effect of lifestyle intervention programmes on offspring mental health, temperament, eating habits and anthropometric and cardiovascular measures.
METHODS
Ninety-six offspring of pregnant women with a body mass index (BMI) ≥29 kg/m2 who were randomly assigned to 3 intervention groups during pregnancy (routine antenatal care, a brochure group or a prenatal session group) and 77 offspring of pregnant women with a normal BMI (between 18.5 and 24.9 kg/m2) were used as an additional control group in this analysis. When the children were between 3 and 7 years old, anthropometric and cardiovascular measurements were conducted and various questionnaires about offspring mental health, temperament and eating habits were filled out.
RESULTS
Children of mothers who received a brochure-based lifestyle intervention programme showed significantly less surgency/extraversion compared to children of mothers who received routine antenatal care (contrast estimate = -0.36, SE = 0.15, p = 0.02, 95% CI [-6.66, -0.06]) and prenatal lifestyle intervention sessions (contrast estimate = -0.46, SE = 0.14, p < 0.01, 95% CI [-0.74, -0.18]) after adjusting for child's age, sex, offspring birth weight and mother's educational level. The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics. Children of mothers with a normal BMI showed less emotional problems (F(1, 156) = 5.42, p = 0.02) and internalizing (F(1, 156) = 3.04, p = 0.08) and externalizing problems (F(1, 156) = 6.10, p = 0.02) when compared to children of mothers in the obese group.
DISCUSSION/CONCLUSION
The results suggest that a brochure-based lifestyle intervention programme can affect the offspring temperament. Future follow-up studies need to investigate how these temperament-related effects may influence obesity development later in life.",2020,"The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics.","['and 77 offspring of pregnant women with a normal BMI (between 18.5 and 24.9 kg/m2', 'Ninety-six offspring of pregnant women with a body mass index (BMI) ≥29 kg/m2 who', 'Children of mothers with a normal BMI', 'Obese Pregnant Women on the Neurocognitive Development and Anthropometrics of Preschool Children', 'women and children']","['Lifestyle Interventions', 'brochure-based lifestyle intervention programme', 'lifestyle intervention programmes', '3 intervention groups during pregnancy (routine antenatal care, a brochure group or a prenatal session group']","['prenatal lifestyle intervention sessions', 'offspring mental health, eating habits and anthropometric and cardiovascular characteristics', 'offspring mental health, temperament, eating habits and anthropometric and cardiovascular measures', 'surgency/extraversion', 'externalizing problems', 'emotional problems', 'weight gain']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0015382', 'cui_str': 'Extroversion, Psychological'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.064488,"The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics.","[{'ForeName': 'Marijke Anne Katrien Alberta', 'Initials': 'MAKA', 'LastName': 'Braeken', 'Affiliation': 'Research Unit Resilient People, Faculty of Health and Social Work, University Colleges Leuven-Limburg, Diepenbeek, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium, annick.bogaerts@kuleuven.be.'}]",Obesity facts,['10.1159/000506690']
456,31095423,Hybrid Closed-Loop Control Is Safe and Effective for People with Type 1 Diabetes Who Are at Moderate to High Risk for Hypoglycemia.,"Background: Typically, closed-loop control (CLC) studies excluded patients with significant hypoglycemia. We evaluated the effectiveness of hybrid CLC (HCLC) versus sensor-augmented pump (SAP) in reducing hypoglycemia in this high-risk population. Methods: Forty-four subjects with type 1 diabetes, 25 women, 37 ± 2 years old, HbA1c 7.4% ± 0.2% (57 ± 1.5 mmol/mol), diabetes duration 19 ± 2 years, on insulin pump, were enrolled at the University of Virginia ( N = 33) and Stanford University ( N = 11). Eligibility: increased risk of hypoglycemia confirmed by 1 week of blinded continuous glucose monitor (CGM); randomized to 4 weeks of home use of either HCLC or SAP. Primary/secondary outcomes: risk for hypoglycemia measured by the low blood glucose index (LBGI)/CGM-based time in ranges. Results: Values reported: mean ± standard deviation. From baseline to the final week of study: LBGI decreased more on HCLC (2.51 ± 1.17 to 1.28 ± 0.5) than on SAP (2.1 ± 1.05 to 1.79 ± 0.98), P < 0.001; percent time below 70 mg/dL (3.9 mmol/L) decreased on HCLC (7.2% ± 5.3% to 2.0% ± 1.4%) but not on SAP (5.8% ± 4.7% to 4.8% ± 4.5%), P = 0.001; percent time within the target range 70-180 mg/dL (3.9-10 mmol/L) increased on HCLC (67.8% ± 13.5% to 78.2% ± 10%) but decreased on SAP (65.6% ± 12.9% to 59.6% ± 16.5%), P < 0.001; percent time above 180 mg/dL (10 mmol/L) decreased on HCLC (25.1% ± 15.3% to 19.8% ± 10.1%) but increased on SAP (28.6% ± 14.6% to 35.6% ± 17.6%), P = 0.009. Mean glucose did not change significantly on HCLC (144.9 ± 27.9 to 143.8 ± 14.4 mg/dL [8.1 ± 1.6 to 8.0 ± 0.8 mmol/L]) or SAP (152.5 ± 24.3 to 162.4 ± 28.2 [8.5 ± 1.4 to 9.0 ± 1.6]), P = ns. Conclusions: Compared with SAP therapy, HCLC reduced the risk and frequency of hypoglycemia, while improving time in target range and reducing hyperglycemia in people at moderate to high risk of hypoglycemia.",2019,"Mean glucose did not change significantly on HCLC (144.9 ± 27.9 to 143.8 ± 14.4 mg/dL [8.1 ± 1.6 to 8.0 ± 0.8 mmol/L]) or SAP (152.5 ± 24.3 to 162.4 ± 28.2 [8.5 ± 1.4 to 9.0 ± 1.6]), P = ns. ","['People with Type 1 Diabetes', 'patients with significant hypoglycemia', 'Methods: Forty-four subjects with type 1 diabetes, 25 women, 37\u2009±\u20092 years old, HbA1c 7.4%\u2009±\u20090.2% (57\u2009±\u20091.5\u2009mmol/mol), diabetes duration 19\u2009±\u20092 years, on insulin pump, were enrolled at the University of Virginia ( N \u2009=\u200933) and Stanford University ( N \u2009=\u200911']","['HCLC or SAP', 'SAP therapy', 'hybrid CLC (HCLC) versus sensor-augmented pump (SAP', 'closed-loop control', 'Hybrid Closed-Loop Control']","['hypoglycemia', 'risk and frequency of hypoglycemia', 'hyperglycemia', 'Mean glucose', 'HCLC', 'SAP', 'mean\u2009±\u2009standard deviation', 'risk of hypoglycemia', 'hypoglycemia measured by the low blood glucose index (LBGI)/CGM-based time in ranges']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",44.0,0.0310865,"Mean glucose did not change significantly on HCLC (144.9 ± 27.9 to 143.8 ± 14.4 mg/dL [8.1 ± 1.6 to 8.0 ± 0.8 mmol/L]) or SAP (152.5 ± 24.3 to 162.4 ± 28.2 [8.5 ± 1.4 to 9.0 ± 1.6]), P = ns. ","[{'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': '1 Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': '2 Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': '1 Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Robic', 'Affiliation': '1 Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Barnett', 'Affiliation': '1 Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Wakeman', 'Affiliation': '1 Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Oliveri', 'Affiliation': '1 Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': '1 Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Trang T', 'Initials': 'TT', 'LastName': 'Ly', 'Affiliation': '2 Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Clinton', 'Affiliation': '2 Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Liana J', 'Initials': 'LJ', 'LastName': 'Hsu', 'Affiliation': '2 Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Kingman', 'Affiliation': '2 Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Norlander', 'Affiliation': '2 Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Loebner', 'Affiliation': '2 Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Reuschel-DiVirglio', 'Affiliation': '2 Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Boris P', 'Initials': 'BP', 'LastName': 'Kovatchev', 'Affiliation': '1 Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0018']
457,32273317,Community-based weight loss programme targeting overweight Chinese adults with pre-diabetes: study protocol of a randomised controlled trial.,"INTRODUCTION
Type 2 diabetes mellitus (T2DM) is one of the world's fastest growing health problems. Asians have a strong ethnic predisposition for T2DM, developing T2DM at a lower degree of obesity and at younger ages than other ethnic groups. T2DM has a gradual onset, with most individuals progressing through a pre-diabetic state, providing an opportunity to prevent T2DM and its complications. This study aims to evaluate the effectiveness of a community-based lifestyle intervention programme on weight loss and improvements in insulin sensitivity and cardiometabolic profiles in Chinese adults with pre-diabetes.
METHODS AND ANALYSIS
This study is a 12-month, assessor-blinded randomised controlled trial. Adults with pre-diabetes (aged 40-64 years, n=180) with pre-diabetes are randomised into either an intervention group (receiving group-based lifestyle interventions) or a control group (receiving text messages containing health information). The intervention programme targets a weight loss of 5% during the first 6 months by restricting caloric intake and increasing physical activity. Participants in the intervention group will attend six group sessions and two individual face-to-face diet counselling sessions during the first 6 months, followed by monthly telephone support during the 6-month maintenance phase. Participants in the control group will receive monthly text messages containing general health information only. The primary outcome is weight loss (%). Secondary outcomes include insulin sensitivity (assessed using fasting insulin level and homeostatic model assessment of insulin resistance), glycaemic control (assessed using glycated haemoglobin level), lipid profile, blood pressure, carotid artery thickness, dietary intake and level of physical activity. Intention-to-treat analysis will be conducted using a generalised linear mixed effects model with a logit link and linear mixed models.
ETHICS AND DISSEMINATION
This study has been approved by the relevant research ethics committee. The results will be disseminated through peer-reviewed journals and scientific presentations.
TRIAL REGISTRATION NUMBER
NCT03609697.",2020,"This study aims to evaluate the effectiveness of a community-based lifestyle intervention programme on weight loss and improvements in insulin sensitivity and cardiometabolic profiles in Chinese adults with pre-diabetes.
METHODS AND ANALYSIS
","['Chinese adults with pre-diabetes', 'Adults with pre-diabetes (aged 40-64 years, n=180) with pre-diabetes', 'overweight Chinese adults with pre-diabetes']","['T2DM', 'community-based lifestyle intervention programme', 'intervention group (receiving group-based lifestyle interventions) or a control group (receiving text messages containing health information', 'monthly text messages containing general health information only', 'Community-based weight loss programme']","['insulin sensitivity (assessed using fasting insulin level and homeostatic model assessment of insulin resistance), glycaemic control (assessed using glycated haemoglobin level), lipid profile, blood pressure, carotid artery thickness, dietary intake and level of physical activity', 'insulin sensitivity and cardiometabolic profiles', 'weight loss']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.110396,"This study aims to evaluate the effectiveness of a community-based lifestyle intervention programme on weight loss and improvements in insulin sensitivity and cardiometabolic profiles in Chinese adults with pre-diabetes.
METHODS AND ANALYSIS
","[{'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, University of Hong Kong Li Ka Shing Faculty of Medicine, Pokfulam, Hong Kong mandyho1@hku.hk.'}, {'ForeName': 'Pui Hing', 'Initials': 'PH', 'LastName': 'Chau', 'Affiliation': 'School of Nursing, University of Hong Kong Li Ka Shing Faculty of Medicine, Pokfulam, Hong Kong.'}, {'ForeName': 'Esther Yee Tak', 'Initials': 'EYT', 'LastName': 'Yu', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong Li Ka Shing Faculty of Medicine, Pokfulam, Hong Kong.'}, {'ForeName': 'Michael Tin-Cheung', 'Initials': 'MT', 'LastName': 'Ying', 'Affiliation': 'Department of Health Technology and Informatics, Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Cindy Lo Kuen', 'Initials': 'CLK', 'LastName': 'Lam', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong Li Ka Shing Faculty of Medicine, Pokfulam, Hong Kong.'}]",BMJ open,['10.1136/bmjopen-2019-035196']
458,31805787,Randomized Trial of an Intervention to Improve Blood Pressure Control in Stroke Survivors.,"BACKGROUND
We conducted the first-of-its kind randomized stroke trial in Africa to test whether a THRIVES (Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke) intervention improved blood pressure (BP) control among patients with stroke.
METHODS AND RESULTS
Intervention comprised a patient global risk factor control report card, personalized phone text-messaging, and educational video. Four hundred patients recruited from 4 distinct medical facilities in Nigeria, aged ≥18 years with stroke-onset within one-year, were randomized to THRIVES intervention and control group. The control group also received text messages, and both groups received modest financial incentives. The primary outcome was mean change in systolic BP (SBP) at 12 months. There were 36.5% females, 72.3% with ischemic stroke; mean age was 57.2±11.7 years; 93.5% had hypertension and mean SBP was 138.33 (23.64) mm Hg. At 12 months, there was no significant difference in SBP reduction from baseline in the THRIVES versus control group (2.32 versus 2.01 mm Hg, P =0.82). In an exploratory analysis of subjects with baseline BP >140/90 mm Hg (n=168), THRIVES showed a significant mean SBP (diastolic BP) decrease of 11.7 (7.0) mm Hg while control group showed a significant mean SBP (diastolic BP) decrease of 11.2 (7.9) mm Hg at 12 months.
CONCLUSIONS
THRIVES intervention did not significantly reduce SBP compared with controls. However, there was similar significant decrease in mean BP in both treatment arms in the subgroup with baseline hypertension. As text-messaging and a modest financial incentive were the common elements between both treatment arms, further research is required to establish whether these measures alone can improve BP control among stroke survivors.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01900756.",2019,"At 12 months, there was no significant difference in SBP reduction from baseline in the THRIVES versus control group (2.32 versus 2.01 mm Hg, P =0.82).","['patients with stroke', 'Stroke Survivors', 'Four hundred patients recruited from 4 distinct medical facilities in Nigeria, aged ≥18 years with stroke-onset within one-year']","['text messages, and both groups received modest financial incentives', 'patient global risk factor control report card, personalized phone text-messaging, and educational video']","['SBP', 'mean SBP (diastolic BP', 'Blood Pressure Control', 'mean change in systolic BP (SBP', 'SBP reduction', 'blood pressure (BP) control', 'mean BP', 'hypertension and mean SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",400.0,0.14993,"At 12 months, there was no significant difference in SBP reduction from baseline in the THRIVES versus control group (2.32 versus 2.01 mm Hg, P =0.82).","[{'ForeName': 'Mayowa O', 'Initials': 'MO', 'LastName': 'Owolabi', 'Affiliation': 'Department of Medicine, University College Hospital and University of Ibadan, Nigeria and Center for Genomic and Precision Medicine, College of Medicine (M.O.O., R.O.A.), University of Ibadan, Nigeria.'}, {'ForeName': 'Mulugeta', 'Initials': 'M', 'LastName': 'Gebregziabher', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Public Health Sciences (M.G.), Medical University of South Carolina.'}, {'ForeName': 'Rufus O', 'Initials': 'RO', 'LastName': 'Akinyemi', 'Affiliation': 'Department of Medicine, University College Hospital and University of Ibadan, Nigeria and Center for Genomic and Precision Medicine, College of Medicine (M.O.O., R.O.A.), University of Ibadan, Nigeria.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Akinyemi', 'Affiliation': 'Department of Epidemiology and Medical Statistics (J.O.A., O. Akpa), University of Ibadan, Nigeria.'}, {'ForeName': 'Onoja', 'Initials': 'O', 'LastName': 'Akpa', 'Affiliation': 'Department of Epidemiology and Medical Statistics (J.O.A., O. Akpa), University of Ibadan, Nigeria.'}, {'ForeName': 'Olanrewaju', 'Initials': 'O', 'LastName': 'Olaniyan', 'Affiliation': 'Department of Economics (O.O.), University of Ibadan, Nigeria.'}, {'ForeName': 'Babatunde L', 'Initials': 'BL', 'LastName': 'Salako', 'Affiliation': 'Department of Medicine (B.L.S., E.U., A.F.), University of Ibadan, Nigeria.'}, {'ForeName': 'Oyedunni', 'Initials': 'O', 'LastName': 'Arulogun', 'Affiliation': 'Department of Health Promotion and Education (O. Arulogun), University of Ibadan, Nigeria.'}, {'ForeName': 'Raelle', 'Initials': 'R', 'LastName': 'Tagge', 'Affiliation': 'Department of Neurosciences (R.T.), Medical University of South Carolina.'}, {'ForeName': 'Ezinne', 'Initials': 'E', 'LastName': 'Uvere', 'Affiliation': 'Department of Medicine (B.L.S., E.U., A.F.), University of Ibadan, Nigeria.'}, {'ForeName': 'Adekunle', 'Initials': 'A', 'LastName': 'Fakunle', 'Affiliation': 'Department of Medicine (B.L.S., E.U., A.F.), University of Ibadan, Nigeria.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Ovbiagele', 'Affiliation': 'Department of Neurology, University of California, San Francisco (B.O.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005904']
459,30901302,"Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non-Germinal Center B-Cell Diffuse Large B-Cell Lymphoma.","PURPOSE
Ibrutinib has shown activity in non-germinal center B-cell diffuse large B-cell lymphoma (DLBCL). This double-blind phase III study evaluated ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in untreated non-germinal center B-cell DLBCL.
PATIENTS AND METHODS
Patients were randomly assigned at a one-to-one ratio to ibrutinib (560 mg per day orally) plus R-CHOP or placebo plus R-CHOP. The primary end point was event-free survival (EFS) in the intent-to-treat (ITT) population and the activated B-cell (ABC) DLBCL subgroup. Secondary end points included progression-free survival (PFS), overall survival (OS), and safety.
RESULTS
A total of 838 patients were randomly assigned to ibrutinib plus R-CHOP (n = 419) or placebo plus R-CHOP (n = 419). Median age was 62.0 years; 75.9% of evaluable patients had ABC subtype disease, and baseline characteristics were balanced. Ibrutinib plus R-CHOP did not improve EFS in the ITT (hazard ratio [HR], 0.934) or ABC (HR, 0.949) population. A preplanned analysis showed a significant interaction between treatment and age. In patients age younger than 60 years, ibrutinib plus R-CHOP improved EFS (HR, 0.579), PFS (HR, 0.556), and OS (HR, 0.330) and slightly increased serious adverse events (35.7% v 28.6%), but the proportion of patients receiving at least six cycles of R-CHOP was similar between treatment arms (92.9% v 93.0%). In patients age 60 years or older, ibrutinib plus R-CHOP worsened EFS, PFS, and OS, increased serious adverse events (63.4% v 38.2%), and decreased the proportion of patients receiving at least six cycles of R-CHOP (73.7% v 88.8%).
CONCLUSION
The study did not meet its primary end point in the ITT or ABC population. However, in patients age younger than 60 years, ibrutinib plus R-CHOP improved EFS, PFS, and OS with manageable safety. In patients age 60 years or older, ibrutinib plus R-CHOP was associated with increased toxicity, leading to compromised R-CHOP administration and worse outcomes. Further investigation is warranted.",2019,"Ibrutinib plus R-CHOP did not improve EFS in the ITT (hazard ratio [HR], 0.934) or ABC (HR, 0.949) population.","['untreated non-germinal center B-cell DLBCL', '838 patients', 'Non-Germinal Center B-Cell Diffuse Large B-Cell Lymphoma', 'Patients', 'patients age younger than 60 years']","['Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone', 'placebo plus R-CHOP', 'Ibrutinib plus R-CHOP', 'ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'ibrutinib plus R-CHOP', 'ibrutinib (560 mg per day orally) plus R-CHOP or placebo plus R-CHOP']","['EFS', 'event-free survival (EFS) in the intent-to-treat (ITT) population and the activated B-cell (ABC) DLBCL subgroup', 'serious adverse events', 'progression-free survival (PFS), overall survival (OS), and safety', 'EFS, PFS, and OS with manageable safety']","[{'cui': 'C0282491', 'cui_str': 'Germinal Center'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",838.0,0.298288,"Ibrutinib plus R-CHOP did not improve EFS in the ITT (hazard ratio [HR], 0.934) or ABC (HR, 0.949) population.","[{'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': '1 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': '2 BC Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': '3 University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': '4 ""Seràgnoli"" University of Bologna, Bologna, Italy.'}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': ""5 Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""6 Peking University Cancer Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Patti', 'Affiliation': '7 Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': '8 Charles University, Hradec Králové, Czech Republic.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Samoilova', 'Affiliation': '10 Regional Clinical Hospital, Nizhny Novgorod, Russian Federation.'}, {'ForeName': 'Cheolwon', 'Initials': 'C', 'LastName': 'Suh', 'Affiliation': '11 University of Ulsan, Seoul, Republic of Korea.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Leppä', 'Affiliation': '12 Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': '14 Kindai University, Osakasayama, Japan.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Turgut', 'Affiliation': '15 Ondokuz Mayis University, Samsun, Turkey.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': '16 Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Cheung', 'Affiliation': '17 Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Gurion', 'Affiliation': '18 Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Su-Peng', 'Initials': 'SP', 'LastName': 'Yeh', 'Affiliation': '20 China Medical University Hospital, Taichung, Republic of China.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Lopez-Hernandez', 'Affiliation': ""21 University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dührsen', 'Affiliation': '22 University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': '23 Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Carlos Sergio', 'Initials': 'CS', 'LastName': 'Chiattone', 'Affiliation': '25 Santa Casa Medical School, São Paulo, Brazil.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Balasubramanian', 'Affiliation': '26 Janssen Research and Development, San Diego, CA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Carey', 'Affiliation': '27 Janssen Research and Development, Spring House, PA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': '28 Janssen Research and Development, Raritan, NJ.'}, {'ForeName': 'S Martin', 'Initials': 'SM', 'LastName': 'Shreeve', 'Affiliation': '26 Janssen Research and Development, San Diego, CA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': '28 Janssen Research and Development, Raritan, NJ.'}, {'ForeName': 'Sen Hong', 'Initials': 'SH', 'LastName': 'Zhuang', 'Affiliation': '28 Janssen Research and Development, Raritan, NJ.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': '29 Janssen Research and Development, Leiden, the Netherlands.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Staudt', 'Affiliation': '30 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Wyndham', 'Initials': 'W', 'LastName': 'Wilson', 'Affiliation': '30 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02403']
460,30969323,"Visit-to-Visit Blood Pressure Variability, Coronary Atheroma Progression, and Clinical Outcomes.","Importance
Visit-to-visit blood pressure variability (BPV) is associated with cardiovascular events, but mechanisms and therapeutic implications underlying this association are not well understood.
Objective
To examine the association of intraindividual BPV, coronary atheroma progression, and clinical outcomes using serial intravascular ultrasonography.
Design, Setting, and Participants
Post hoc patient-level analysis of 7 randomized clinical trials conducted from 2004 to 2016 involving 3912 patients in multicenter, international, clinic-based primary and tertiary care centers. Adult patients with coronary artery disease who underwent serial intravascular ultrasonography in the setting of a range of medical therapies were included. Data were analyzed between November 2017 and March 2019.
Exposures
Visit-to-visit BPV measured using intraindividual standard deviation over 3, 6, 12, 18, and 24 months.
Main Outcomes and Measures
Percent atheroma volume (PAV) progression and major adverse cardiovascular events (defined as death, myocardial infarction, stroke, urgent revascularization for acute coronary syndrome, and hospitalization for unstable angina).
Results
Of 3912 patients, the mean (SD) age was 58 (9) years, 1093 (28%) were women, and 3633 (93%) were white . Continuous change in PAV was significantly associated with systolic BPV (β, .049; 95% CI, 0.021-0.078; P = .001), diastolic BPV (β, .031; 95% CI, 0.002-0.059; P = .03), and pulse pressure variability (β, .036; 95% CI, 0.006-0.067; P = .02), without a signal for differential effect greater than or less than a mean BP of 140/90 mm Hg. The PAV progression as a binary outcome was significantly associated with systolic BPV (odds ratio, 1.09; 95% CI, 1.01-1.17; P = .02) but not diastolic BPV (odds ratio, 1.04; 95% CI, 0.97-1.11; P = .30) or pulse pressure variability (odds ratio, 1.03; 95% CI, 0.96-1.10; P = .47). Survival curves revealed a significant stepwise association between cumulative major adverse cardiovascular events and increasing quartiles of systolic BPV (Kaplan-Meier estimates for quartiles 1-4: 6.1% vs 8.5% vs 10.1% vs 12.0%, respectively; log-rank P <.001). These distinct stepwise associations were not seen with diastolic BPV or pulse pressure variability.
Conclusions and Relevance
Greater BPV, particularly systolic BPV, is significantly associated with coronary atheroma progression and adverse clinical outcomes. These data suggest maintaining stable blood pressure levels may be important to further improve outcomes in patients with coronary disease.",2019,"The PAV progression as a binary outcome was significantly associated with systolic BPV (odds ratio, 1.09; 95% CI, 1.01-1.17; P = .02) but not diastolic BPV (odds ratio, 1.04; 95% CI, 0.97-1.11; P = .30) or pulse pressure variability (odds ratio, 1.03; 95% CI, 0.96-1.10; P = .47).","['patients with coronary disease', '3912 patients', 'Adult patients with coronary artery disease who underwent serial intravascular ultrasonography in the setting of a range of medical therapies were included', '2004 to 2016 involving 3912 patients in multicenter, international, clinic-based primary and tertiary care centers', 'the mean (SD) age was 58 (9) years, 1093 (28%) were women, and 3633 (93%) were white ']",[],"['pulse pressure variability', 'systolic BPV', 'Visit-to-Visit Blood Pressure Variability, Coronary Atheroma Progression, and Clinical Outcomes', 'atheroma volume (PAV) progression and major adverse cardiovascular events (defined as death, myocardial infarction, stroke, urgent revascularization for acute coronary syndrome, and hospitalization for unstable angina', 'diastolic BPV or pulse pressure variability', 'diastolic BPV', 'quartiles of systolic BPV (Kaplan-Meier estimates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0206520', 'cui_str': 'Ultrasonography, Intravascular'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],"[{'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0264683', 'cui_str': 'Coronary artery atheroma (disorder)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0264956', 'cui_str': 'Atheromatous Plaques'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}]",3912.0,0.127504,"The PAV progression as a binary outcome was significantly associated with systolic BPV (odds ratio, 1.09; 95% CI, 1.01-1.17; P = .02) but not diastolic BPV (odds ratio, 1.04; 95% CI, 0.97-1.11; P = .30) or pulse pressure variability (odds ratio, 1.03; 95% CI, 0.96-1.10; P = .47).","[{'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Mississippi Medical Center, Jackson.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'St John', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Mohamed B', 'Initials': 'MB', 'LastName': 'Elshazly', 'Affiliation': 'Division of Cardiology, Department of Medicine, Weill Cornell Medical College-Qatar, Education City, Doha, Qatar.'}, {'ForeName': 'Haitham M', 'Initials': 'HM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Khraishah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA cardiology,['10.1001/jamacardio.2019.0751']
461,30969342,Effect of Developmentally Adapted Cognitive Processing Therapy for Youth With Symptoms of Posttraumatic Stress Disorder After Childhood Sexual and Physical Abuse: A Randomized Clinical Trial.,"Importance
Despite the high prevalence, evidence-based treatments for abuse-related posttraumatic stress disorder (PTSD) in adolescents have rarely been studied.
Objective
To examine whether developmentally adapted cognitive processing therapy (D-CPT) is more effective than a wait-list condition with treatment advice (WL/TA) among adolescents with PTSD related to childhood abuse.
Design, Setting, and Participants
This rater-blinded, multicenter, randomized clinical trial (stratified by center) enrolled treatment-seeking adolescents and young adults (aged 14-21 years) with childhood abuse-related PTSD at 3 university outpatient clinics in Germany from July 2013 to June 2015, with the last follow-up interview conducted by May 2016. Of 194 patients, 88 were eligible for randomization.
Interventions
Participants received D-CPT or WL/TA. Cognitive processing therapy was enhanced by a motivational and alliance-building phase, by including emotion regulation and consideration of typical developmental tasks, and by higher session frequency in the trauma-focused core CPT phase. In WL/TA, participants received treatment advice with respective recommendations of clinicians and were offered D-CPT after 7 months.
Main Outcomes and Measures
All outcomes were assessed before treatment (baseline), approximately 8 weeks after the start of treatment, after the end of treatment (posttreatment), and at the 3-month follow-up. The primary outcome, PTSD symptom severity, was assessed in clinical interview (Clinician-Administered PTSD Scale for Children and Adolescents for DSM-IV [CAPS-CA]). Secondary outcomes were self-reported PTSD severity, depression, borderline symptoms, behavior problems, and dissociation.
Results
The 88 participants (75 [85%] female) had a mean age of 18.1 years (95% CI, 17.6-18.6 years). In the intention-to-treat analysis, the 44 participants receiving D-CPT (39 [89%] female) demonstrated greater improvement than the 44 WL/TA participants (36 [82%] female) in terms of PTSD severity (mean CAPS-CA scores, 24.7 [95% CI, 16.6-32.7] vs 47.5 [95% CI, 37.9-57.1]; Hedges g = 0.90). This difference was maintained through the follow-up (mean CAPS-CA scores, 25.9 [95% CI, 16.2-35.6] vs 47.3 [95% CI, 37.8-56.8]; Hedges g = 0.80). Treatment success was greatest during the trauma-focused core phase. The D-CPT participants also showed greater and stable improvement in all secondary outcomes, with between-groups effect sizes ranging from 0.65 to 1.08 at the posttreatment assessment (eg, for borderline symptoms, 14.1 [95% CI, 8.0-20.2] vs 32.0 [95% CI, 23.8-40.2]; Hedges g = 0.91).
Conclusions and Relevance
Adolescents and young adults with abuse-related PTSD benefited more from D-CPT than from WL/TA. Treatment success was stable at the follow-up and generalized to borderline symptoms and other comorbidities.
Trial Registration
German Clinical Trials Register identifier: DRKS00004787.",2019,"This difference was maintained through the follow-up (mean CAPS-CA scores, 25.9 [95% CI, 16.2-35.6] vs 47.3 [95% CI, 37.8-56.8];","['88 participants (75 [85%] female) had a mean age of 18.1 years (95% CI, 17.6-18.6 years', 'adolescents with PTSD related to childhood abuse', 'After Childhood Sexual and Physical Abuse', 'center) enrolled treatment-seeking adolescents and young adults (aged 14-21 years) with childhood abuse-related PTSD at 3 university outpatient clinics in Germany from July 2013 to June 2015, with the last follow-up interview conducted by May 2016', '194 patients, 88 were eligible for randomization', 'Youth With Symptoms of Posttraumatic Stress Disorder']","['adapted cognitive processing therapy (D-CPT', 'Cognitive processing therapy', 'Developmentally Adapted Cognitive Processing Therapy', 'D-CPT or WL/TA']","['PTSD symptom severity', 'clinical interview (Clinician-Administered PTSD Scale for Children and Adolescents for DSM-IV [CAPS-CA', 'PTSD severity', 'self-reported PTSD severity, depression, borderline symptoms, behavior problems, and dissociation']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C1621955', 'cui_str': 'Physical Maltreatment'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0086168', 'cui_str': 'Dissociation'}]",,0.13041,"This difference was maintained through the follow-up (mean CAPS-CA scores, 25.9 [95% CI, 16.2-35.6] vs 47.3 [95% CI, 37.8-56.8];","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Rosner', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Rimane', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Frick', 'Affiliation': 'Hochschule Döpfer, University of Applied Sciences, Research Centre, University of Applied Sciences, Köln, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Gutermann', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hagl', 'Affiliation': 'Freelance researcher in München, Germany.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Renneberg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Freie Universitaet of Berlin, Berlin, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Schreiber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Steil', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Frankfurt am Main, Germany.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2018.4349']
462,32271182,Comparison of Adductor Canal Block and Femoral Triangle Block for Total Knee Arthroplasty.,"OBJECTIVES
Adductor canal block (ACB) could provide effective postoperative pain control for patients after total knee arthroplasty (TKA). However, some authors pointed out that the ACB as originally described may be more similar to a femoral triangle block (FTB). Recent neuroanatomic evidences made the authors conjecture that the ""true"" ACB would provide superior analgesia compared with FTB. Therefore, the study was designed to determine the hypothesis that postoperative analgesia after TKA could be improved by a ""true"" ACB compared with FTB.
MATERIALS AND METHODS
Patients undergoing unilateral, primary TKA were randomized into the ACB group or FTB group. The primary outcome was postoperative pain during active flexion at 8 hours after surgery measured by the visual analog scale (VAS). In addition, pain scores at other time points, quadriceps strength, morphine consumption, satisfaction of the patient, and side effects of morphine were also evaluated.
RESULTS
Sixty participants completed the research. The VAS scores were lower in the ACB group than the FTB group at 8 and 24 hours at rest (P<0.05). The VAS scores were lower in the ACB group than the FTB group at 4, 8, 24, and 48 hours during active flexion (P<0.05). The quadriceps strength was superior in the ACB group than the FTB group at 4, 8, and 24 hours (P<0.05). The consumption of morphine was lower in the ACB group than the FTB group (P<0.05). However, there were no significant differences for both patient satisfaction and the incidence of adverse reactions (P>0.05).
DISCUSSION
ACB can provide superior analgesia and preserve more quadriceps strength than FTB. ACB facilitates functional recovery in the early stages and is compatible with the highly recognized concept of rapid rehabilitation, which should be promoted in the clinic.",2020,"However, there were no significant differences for both patient satisfaction and incidence of adverse reaction (P>0.05).
","['Sixty subjects completed the research', 'Subjects undergoing unilateral, primary TKA', 'patients following total knee arthroplasty (TKA', 'Total Knee Arthroplasty']","['TKA', 'Adductor Canal Block and Femoral Triangle Block', 'Adductor canal block (ACB', 'FTB', 'ACB']","['consumption of morphine', 'quadriceps strength', 'postoperative pain during active flexion at 8 hours after surgery measured by visual analogue scale (VAS', 'quadriceps strength, morphine consumption, satisfactions of patient and side effects of morphine', 'pain scores', 'patient satisfaction and incidence of adverse reaction', 'VAS scores']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0225265', 'cui_str': 'Femoral triangle structure'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0224440', 'cui_str': 'Structure of quadriceps femoris muscle'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0422618,"However, there were no significant differences for both patient satisfaction and incidence of adverse reaction (P>0.05).
","[{'ForeName': 'Chun-Guang', 'Initials': 'CG', 'LastName': 'Wang', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'Ding', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': 'Medical Ultrasonics.'}, {'ForeName': 'Jia-Yun', 'Initials': 'JY', 'LastName': 'Liu', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Orthopedics, The First Center Hospital of Baoding, Baoding, Hebei, China.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000833']
463,32271183,"Efficacy and Safety of Single and Multiple Doses of a Fixed-dose Combination of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: Results From 2 Phase 3, Randomized, Parallel-group, Double-blind, Placebo-controlled Studies.","OBJECTIVES
A previous pilot study demonstrated that various fixed-dose combinations (FDCs) of ibuprofen (IBU) and acetaminophen (APAP) provided analgesic efficacy comparable to a higher dose of IBU, with the same safety profile. These studies further evaluated the chosen FDC IBU/APAP 250/500 mg formulation.
MATERIALS AND METHODS
Two phase 3 dental pain studies enrolled healthy young patients with ≥moderate pain after ≥3 third molar extractions who received single-dose FDC IBU/APAP 250/500 mg, IBU 250 mg, APAP 650 mg, or placebo evaluated over 12 hours (study 1) or multiple-dose FDC or placebo every 8 hours, evaluated over 48 hours (study 2). Time-weighted sum of pain intensity differences over 8 (SPID[11]0-8) and 24 (SPID[11]0-24) hours were primary outcomes, respectively. Time to meaningful pain relief and duration of pain relief were assessed; tolerability was evaluated by adverse events.
RESULTS
Five hundred sixty-eight patients were randomized in study 1; 123 in study 2. Study 1: SPID[11]0-8 favored FDC significantly over placebo, IBU, and APAP (P<0.001, P=0.008, and P<0.001, respectively); study 2: SPID[11]0-24 significantly favored FDC over placebo (P<0.001), with sustained efficacy during multiple dosing. Time to meaningful pain relief occurred within 1 hour; pain relief duration was >8 hours in both studies. Adverse event rates were lowest with the FDC.
DISCUSSION
FDC IBU/APAP 250/500 mg provides superior analgesic efficacy to individual monocomponents (IBU 250 mg and APAP 650 mg), a rapid onset of action, >8-hour duration of pain relief, is generally well tolerated, and may provide an additional nonopioid treatment option for acute pain.",2020,▒mg provides superior analgesic efficacy to individual monocomponents,"['568 patients were randomized in Study 1; 123 in Study 2', 'Two phase 3 dental pain studies enrolled healthy young patients with ≥moderate pain after ≥3 third molar extractions who received', 'Postsurgical Dental Pain']","['FDC over placebo', 'individual monocomponents', 'ibuprofen (IBU) and acetaminophen (APAP', 'Placebo', 'single-dose FDC IBU/APAP 250▒mg/500▒mg, IBU 250▒mg, APAP 650▒mg, or placebo', 'Ibuprofen and Acetaminophen', 'multiple-dose FDC or placebo']","['Time to meaningful pain relief (TMPR) and duration of pain relief', 'TMPR', 'analgesic efficacy', 'Time-weighted sum of pain intensity differences', 'pain relief duration', 'Efficacy and Safety', 'AE rates', 'FDC significantly over placebo, IBU, and APAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]",568.0,0.336205,▒mg provides superior analgesic efficacy to individual monocomponents,"[{'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Searle', 'Affiliation': 'PRA Health Sciences.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Muse', 'Affiliation': 'Jean Brown Research Inc., Salt Lake City, UT.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Paluch', 'Affiliation': 'Independent Consultant.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Leyva', 'Affiliation': 'Pfizer Consumer Healthcare, Madison.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'DePadova', 'Affiliation': 'Pfizer Consumer Healthcare, Madison.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cruz-Rivera', 'Affiliation': 'Rx-to-OTC Switch, Sanofi Consumer Health Care, Bridgewater, NJ.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kellstein', 'Affiliation': 'Independent Consultant.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000828']
464,31860104,Effect of a Motivational Interviewing-Based Intervention on Initiation of Mental Health Treatment and Mental Health After an Emergency Department Visit Among Suicidal Adolescents: A Randomized Clinical Trial.,"Importance
Emergency department (ED) visits present opportunities to identify and refer suicidal youth for outpatient mental health care, although this practice is not routine.
Objective
To examine whether a motivational interviewing-based intervention increases linkage of adolescents to outpatient mental health services and reduces depression symptoms and suicidal ideation in adolescents seeking emergency care for non-mental health-related concerns who screen positive for suicide risk.
Design, Setting, and Participants
In this randomized clinical trial, adolescents aged 12 to 17 years who screened positive on the Ask Suicide Screening Questions (ASQ) during a nonpsychiatric ED visit at 2 academic pediatric EDs in Ohio were recruited from April 2013 to July 2015. Intention-to-treat analyses were performed from September 2018 to October 2019.
Interventions
The Suicidal Teens Accessing Treatment After an Emergency Department Visit (STAT-ED) intervention included motivational interviewing to target family engagement, problem solving, referral assistance, and limited case management. The enhanced usual care (EUC) intervention consisted of brief mental health care consultation and referral.
Main Outcomes and Measures
Primary outcomes were mental health treatment initiation and attendance within 2 months of ED discharge and suicidal ideation (assessed by the Suicidal Ideation Questionnaire JR) and depression symptoms (assessed by the Center for Epidemiologic Studies-Depression scale) at 2 and 6 months. Exploratory outcomes included treatment initiation and attendance and suicide attempts at 6 months.
Results
A total of 168 participants were randomized and 159 included in the intention-to-treat analyses (mean [SD] age, 15.0 [1.5] years; 126 [79.2%] female; and 80 [50.3%] white). Seventy-nine participants were randomized to receive the STAT-ED intervention and 80 to receive EUC. At 2 months, youth in the STAT-ED group had similar rates of mental health treatment initiation compared with youth in the EUC group as assessed by parent report (29 [50.9%] vs 22 [34.9%]; adjusted odds ratio [OR], 2.08; 95% CI, 0.97-4.45) and administrative data from mental health care agencies (19 [29.7%] vs 11 [19.3%]; adjusted OR, 1.77; 95% CI, 0.76-4.15). At 2 months, youth in the STAT-ED group and the EUC group had similar rates of treatment attendance (1 appointment: 6 [9.7%] vs 2 [3.6%]; adjusted OR, 2.97; 95% CI, 0.56-15.73; ≥2 appointments: 10 [16.1%] vs 7 [12.7%]; adjusted OR, 1.43; 95% CI, 0.50-4.11). There were no significant group × time differences in suicidal ideation (F = 0.28; P = .72) and depression symptoms (F = 0.49; P = .60) during the 6-month follow-up period. In exploratory analyses, at 6 months, STAT-ED participants had significantly higher rates of agency-reported mental health treatment initiation (adjusted OR, 2.48; 95% CI, 1.16-5.28) and more completed appointments (t99.7 = 2.58; P = .01).
Conclusions and Relevance
This study's findings indicate that no differences were found on any primary outcome by study condition. However, STAT-ED was more efficacious than EUC at increasing mental health treatment initiation and attendance at 6 months.
Trial Registration
ClinicalTrials.gov identifier: NCT01779414.",2019,There were no significant group × time differences in suicidal ideation (F = 0.28; P = .72) and depression symptoms (F = 0.49; P = .60) during the 6-month follow-up period.,"['adolescents seeking emergency care for non-mental health-related concerns who screen positive for suicide risk', 'adolescents to outpatient mental health services', 'A total of 168 participants were randomized and 159 included in the intention-to-treat analyses (mean [SD] age, 15.0 [1.5] years; 126 [79.2%] female; and 80 [50.3%] white', 'adolescents aged 12 to 17 years who screened positive on the Ask Suicide Screening Questions (ASQ) during a nonpsychiatric ED visit at 2 academic pediatric EDs in Ohio were recruited from April 2013 to July 2015', 'Suicidal Teens Accessing Treatment', 'Seventy-nine participants', 'Suicidal Adolescents']","['Emergency Department Visit (STAT-ED) intervention included motivational interviewing to target family engagement, problem solving, referral assistance, and limited case management', 'motivational interviewing-based intervention', 'EUC', 'STAT-ED intervention and 80 to receive EUC', 'Motivational Interviewing-Based Intervention', 'enhanced usual care (EUC) intervention consisted of brief mental health care consultation and referral']","['rates of treatment attendance', 'mental health treatment initiation and attendance within 2 months of ED discharge and suicidal ideation (assessed by the Suicidal Ideation Questionnaire JR) and depression symptoms (assessed by the Center for Epidemiologic Studies-Depression scale', 'Initiation of Mental Health Treatment and Mental Health', 'rates of mental health treatment initiation', 'rates of agency-reported mental health treatment initiation', 'suicidal ideation', 'treatment initiation and attendance and suicide attempts at 6 months', 'depression symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1527398', 'cui_str': 'Emergency Care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0205548', 'cui_str': 'Stat (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0034928', 'cui_str': 'Referral and Consultation'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}]",79.0,0.222037,There were no significant group × time differences in suicidal ideation (F = 0.28; P = .72) and depression symptoms (F = 0.49; P = .60) during the 6-month follow-up period.,"[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Grupp-Phelan', 'Affiliation': ""Division of Pediatric Emergency Medicine, UCSF (University of California, San Francisco) Benioff Children's Hospitals, San Francisco, California.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': ""Department of Pediatrics, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Boyd', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Cohen', 'Affiliation': ""Division of Emergency Medicine, Nationwide Children's Hospital, The Ohio State University, Columbus.""}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Ammerman', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Liddy-Hicks', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Heck', 'Affiliation': ""Department of Pediatrics, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Marcus', 'Affiliation': 'University of Pennsylvania School of Social Policy and Practice, Philadelphia.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Stone', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Campo', 'Affiliation': 'Department of Behavioral Medicine and Psychiatry, West Virginia University and the Rockefeller Neuroscience Institute, Morgantown.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Bridge', 'Affiliation': ""Department of Pediatrics, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.17941']
465,32271671,Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx.,"PURPOSE
Cancer-related cognitive impairment (CRCI) is common during adjuvant chemotherapy and may persist. TAILORx provided a novel opportunity to prospectively assess patient-reported cognitive impairment among women with early breast cancer who were randomly assigned to chemoendocrine therapy (CT+E) versus endocrine therapy alone (E), allowing us to quantify the unique contribution of chemotherapy to CRCI.
METHODS
Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX were randomly assigned to CT+E or E. Cognitive impairment was assessed among a subgroup of 552 evaluable women using the 37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire, administered at baseline, 3, 6, 12, 24, and 36 months. The FACT-Cog included the 20-item Perceived Cognitive Impairment (PCI) scale, our primary end point. Clinically meaningful changes were defined a priori and linear regression was used to model PCI scores on baseline PCI, treatment, and other factors.
RESULTS
FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups. The magnitude of PCI change scores was greater for CT+E than E at 3 months, the prespecified primary trial end point, and at 6 months, but not at 12, 24, and 36 months. Tests of an interaction between menopausal status and treatment were nonsignificant.
CONCLUSION
Adjuvant CT+E is associated with significantly greater CRCI compared with E at 3 and 6 months. These differences abated over time, with no significant differences observed at 12 months and beyond. These findings indicate that chemotherapy produces early, but not sustained, cognitive impairment relative to E, providing reassurance to patients and clinicians in whom adjuvant chemotherapy is indicated to reduce recurrence risk.",2020,"RESULTS
FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","['Women', '552 evaluable women using the', 'women with early breast cancer', 'Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX']","['37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire', 'chemoendocrine therapy (CT+E) versus endocrine therapy alone (E', 'Endocrine Therapy', 'Chemoendocrine Therapy', 'Adjuvant CT+E', 'CT+E', 'TAILORx']","['FACT-Cog PCI scores', '20-item Perceived Cognitive Impairment (PCI) scale', 'Cognitive Impairment', 'PCI change scores', 'CRCI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",552.0,0.0961332,"RESULTS
FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","[{'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'ECOG-ACRIN Cancer Research Group Biostatistics Center, Boston, MA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'McMaster University, Canadian Cancer Trials Group, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'University of Wisconsin Madison, Carbone Cancer Center, Madison, WI.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kathleen I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Virginia Commonwealth University Massey Cancer Center Minority/Underserved National Cancer Institute Community Oncology Research Program, Richmond, VA.'}, {'ForeName': 'E Claire', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Worta J', 'Initials': 'WJ', 'LastName': 'McCaskill-Stevens', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01866']
466,31163974,Renal Effects of Intensive Volume Removal in Heart Failure Patients With Preexisting Worsening Renal Function.,"Background The relationship between intensive volume removal in acute decompensated heart failure patients with preexisting worsening renal function (WRF) and renal tubular injury, postdischarge renal function, and clinical outcomes is unknown. Methods and Results We used data from the multicenter CARRESS-HF trial (Cardiorenal Rescue Study in Acute Decompensated Heart Failure) that randomized patients with acute decompensated heart failure and preexisting WRF to intensive volume removal with stepped pharmacological therapy or fixed rate ultrafiltration. Patients in the urinary renal tubular injury biomarker substudy (NAG [N-acetyl-b-D-glucosaminidase], KIM-1 [kidney injury molecule-1], and NGAL [neutrophil gelatinase-associated lipocalin]) were evaluated (N=105). The severity of prerandomization WRF was unrelated to baseline renal tubular injury biomarkers ( r=0.14; P=0.17). During randomized intensive volume removal, creatinine further worsened in 53% of patients. Despite a small to moderate magnitude increase in creatinine in most of these patients, postrandomization WRF was strongly associated with worsening in renal tubular injury biomarkers (odds ratio, 12.6; P=0.004). This observation did not differ by mode of volume removal (stepped pharmacological therapy versus ultrafiltration, P interaction =0.46). Increase in renal tubular injury biomarkers was associated with a higher incidence of hemoconcentration (odds ratio, 3.1; P=0.015), and paradoxically, better recovery of creatinine at 60 days ( P=0.01). Conclusions In acute decompensated heart failure patients with preexisting WRF, intensive volume removal resulted in a further worsening of creatinine approximately half of the time, a finding associated with a rise in tubular injury biomarkers. However, decongestion and renal function recovery at 60 days were superior in patients with increased tubular injury markers. These data suggest that the benefits of decongestion may outweigh any modest or transient increases in serum creatinine or tubular injury markers that occur during intensive volume removal. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00608491.",2019,"Increase in renal tubular injury biomarkers was associated with a higher incidence of hemoconcentration (odds ratio, 3.1; P=0.015), and paradoxically, better recovery of creatinine at 60 days ( P=0.01).","['acute decompensated heart failure patients with preexisting worsening renal function (WRF) and renal tubular injury, postdischarge renal function', 'Heart Failure Patients With Preexisting Worsening Renal Function', 'Acute Decompensated Heart Failure) that randomized patients with acute decompensated heart failure and preexisting WRF to intensive volume removal with stepped pharmacological therapy or fixed rate ultrafiltration']",['Intensive Volume Removal'],"['renal tubular injury biomarkers', 'tubular injury biomarkers', 'decongestion and renal function recovery', 'severity of prerandomization WRF', 'hemoconcentration']","[{'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C4324374', 'cui_str': 'Renal tubular injury'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C4324374', 'cui_str': 'Renal tubular injury'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0854379', 'cui_str': 'Haemoconcentration'}]",,0.0997049,"Increase in renal tubular injury biomarkers was associated with a higher incidence of hemoconcentration (odds ratio, 3.1; P=0.015), and paradoxically, better recovery of creatinine at 60 days ( P=0.01).","[{'ForeName': 'Veena S', 'Initials': 'VS', 'LastName': 'Rao', 'Affiliation': 'Sections of Cardiovascular Medicine (V.S.R., T.A., D.D.M., E.J.V., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Sections of Cardiovascular Medicine (V.S.R., T.A., D.D.M., E.J.V., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Brisco-Bacik', 'Affiliation': 'Cardiology Division, Lewis Katz School of Medicine at Temple University, Philadelphia, PA (M.A.B.-B.).'}, {'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Bonventre', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Boston. MA (J.V.B.).""}, {'ForeName': 'F Perry', 'Initials': 'FP', 'LastName': 'Wilson', 'Affiliation': 'Nephrology (F.P.W.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Siew', 'Affiliation': 'Division of Nephrology and Hypertension, Vanderbilt Center for Kidney Disease (VCKD) and Integrated Program for AKI (VIP-AKI), Department of Medicine, Vanderbilt University Medical Center, Nashville, TN (E.D.S.).'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke University Medical Center and Duke Clinical Research Institute, Durham, NC (G.M.F., K.K.A.).'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Anstrom', 'Affiliation': 'Duke University Medical Center and Duke Clinical Research Institute, Durham, NC (G.M.F., K.K.A.).'}, {'ForeName': 'Devin D', 'Initials': 'DD', 'LastName': 'Mahoney', 'Affiliation': 'Sections of Cardiovascular Medicine (V.S.R., T.A., D.D.M., E.J.V., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Bart', 'Affiliation': 'Division of Cardiology, Hennepin County Medical Center, Minneapolis, MN (B.A.B.).'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Section of Heart Failure and Cardiac Transplantation, Cleveland Clinic, OH (W.H.W.T.).'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Sections of Cardiovascular Medicine (V.S.R., T.A., D.D.M., E.J.V., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': 'Sections of Cardiovascular Medicine (V.S.R., T.A., D.D.M., E.J.V., J.M.T.), Yale University School of Medicine, New Haven, CT.'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.118.005552']
467,31207561,Health-related quality of life in remitted psychotic depression ✰ .,"BACKGROUND
Some patients with major depression continue to demonstrate deficits in health-related quality of life (HRQL) following remission. No data exist, however, regarding HRQL in remitted psychotic depression. In this study, we aimed to characterize HRQL in patients with psychotic depression receiving controlled pharmacotherapy.
METHODS
This is a secondary analysis of a randomized controlled trial studying continuation pharmacotherapy of psychotic depression. We compared participants' HRQL (measured using the SF-36) between baseline and remission and to population norms. We also compared SF-36 scores stratified by age and gender and examined the correlation between SF-36 scores and medical burden, depression score and neuropsychological performance in remission.
RESULTS
SF-36 scores were significantly lower than population norms at baseline, but improved following remission to the level of population norms. Neither SF-36 scores nor magnitude of SF-36 improvement differed substantially between genders or between younger and older participants. In remission, depression scores were correlated with most SF-36 scales and medical burden was correlated with SF-36 scales measuring physical symptoms. Neuropsychological measures were generally not correlated with SF-36 scores.
LIMITATIONS
This study was a secondary analysis not powered specifically to measure HRQL as an outcome variable and the SF-36 was the only HRQL measure used.
CONCLUSIONS
Participants with remitted psychotic depression demonstrated levels of HRQL comparable to population norms, despite marked impairment in HRQL when acutely ill. This finding suggests that, when treated in a rigorous manner, many patients with this severe illness improve significantly from a clinical and HRQL perspective.",2019,Neither SF-36 scores nor magnitude of SF-36 improvement differed substantially between genders or between younger and older participants.,"['patients with major depression', 'psychotic depression', 'patients with psychotic depression receiving controlled pharmacotherapy', 'remitted psychotic depression ✰ ']",['HRQL'],"['SF-36 scores nor magnitude of SF-36 improvement', 'SF-36 scales and medical burden', 'Neuropsychological measures', 'SF-36 scores and medical burden, depression score and neuropsychological performance in remission', 'remission, depression scores', 'SF-36 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.132489,Neither SF-36 scores nor magnitude of SF-36 improvement differed substantially between genders or between younger and older participants.,"[{'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Bingham', 'Affiliation': 'University of Toronto, Department of Psychiatry, Toronto, ON, Canada. Electronic address: kathleen.bingham@uhn.ca.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Whyte', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, Pittsburgh, PA, United States.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'University of Toronto, Department of Psychiatry, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School, Department of Psychiatry, Worcester, MA, United States.'}, {'ForeName': 'Matthew V', 'Initials': 'MV', 'LastName': 'Rudorfer', 'Affiliation': 'National Institute of Mental Health, Rockville, MD, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marino', 'Affiliation': 'Weill Cornell Medical College, Department of Psychiatry, New York, NY, United States.'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Weill Cornell Medical College, Department of Biostatistics and Epidemiology, New York, NY, United States.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, Pittsburgh, PA, United States.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Medicine, New York-Presbyterian/Westchester Division, White Plains, NY, United States.'}, {'ForeName': 'Barnett S', 'Initials': 'BS', 'LastName': 'Meyers', 'Affiliation': 'Weill Cornell Medicine, New York-Presbyterian/Westchester Division, White Plains, NY, United States.'}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Flint', 'Affiliation': 'University of Toronto, Department of Psychiatry, Toronto, ON, Canada; University Health Network, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of affective disorders,['10.1016/j.jad.2019.05.068']
468,32271184,Pressure Pain Tolerance Predicts the Success of Emotional Awareness and Expression Therapy in Patients With Fibromyalgia.,"OBJECTIVES
Quantitative sensory testing may help predict treatment responses in individuals with chronic pain. Our objective was to determine whether evoked pain sensitivity at baseline predicted preferential treatment responses to either emotional awareness and expression therapy (EAET) or cognitive behavioral therapy (CBT) in individuals with fibromyalgia (FM).
METHODS
This was a secondary analysis of a previous randomized clinical trial, in which individuals with FM were randomized to EAET, CBT, or Education as a control intervention. Only females who completed baseline and post-treatment assessments were analyzed (n=196). The primary outcome was change in overall clinical pain severity from pretreatment to posttreatment, and the primary predictor of interest was pressure pain tolerance at baseline.
RESULTS
Among patients with low pain tolerance at baseline (n=154), both EAET and CBT led to small but significant improvements in clinical pain severity (CBT mean=0.66, 95% confidence interval [0.24-1.07]; EAET mean=0.76 [0.34-1.17]). Conversely, in patients with normal pain tolerance (n=42), there was no significant improvement in clinical pain after CBT (0.13 [-0.88 to 1.14]), a small improvement after FM Education (0.81 [0.14-1.48]), but a much larger and statistically significant improvement after EAET (2.14 [1.23-3.04]).
DISCUSSION
Normal levels of pressure pain tolerance at baseline predicted greater improvement in clinical pain severity after EAET than CBT. Quantitative sensory testing may provide insights about individual responses to psychologically based therapies for individuals with chronic pain.",2020,"Conversely, in patients with normal pain tolerance (n=42), there was no significant improvement in clinical pain after CBT (0.13","['Patients with Fibromyalgia', 'individuals with chronic pain', 'individuals with fibromyalgia']","['Quantitative sensory testing (QST', 'QST', 'emotional awareness and expression therapy (EAET) or cognitive behavioral therapy (CBT']","['clinical pain severity', 'normal pain tolerance', 'overall clinical pain severity', 'pressure pain tolerance', 'low pain tolerance', 'clinical pain', 'evoked pain sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",,0.337402,"Conversely, in patients with normal pain tolerance (n=42), there was no significant improvement in clinical pain after CBT (0.13","[{'ForeName': 'Tiffany R', 'Initials': 'TR', 'LastName': 'Bellomo', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schrepf', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'Grant H', 'Initials': 'GH', 'LastName': 'Kruger', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Providence Park Hospital, Ascension Health, Novi.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Clauw', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Harte', 'Affiliation': 'Department of Anesthesiology, Chronic Pain and Fatigue Research Center.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000829']
469,32213509,"Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial.","OBJECTIVE
To assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura.
DESIGN
Multicentre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician.
SETTING
Seven hospitals in China, 5 June 2016 to 15 November 2018.
PARTICIPANTS
150 acupuncture naive patients with episodic migraine without aura.
INTERVENTIONS
20 sessions of manual acupuncture at true acupuncture points plus usual care, 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care, or usual care alone over 8 weeks.
MAIN OUTCOME MEASURES
Change in migraine days and migraine attacks per four weeks during weeks 1-20 after randomisation compared with baseline (four weeks before randomisation).
RESULTS
Among 150 randomised patients (mean age 36.5 (SD 11.4) years; 123 (82%) women), 147 were included in the full analysis set. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham (adjusted difference -1.4, 95% confidence interval -2.4 to -0.3; P=0.005) at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham (adjusted difference -2.1, -2.9 to -1.2; P<0.001) at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham (adjusted difference -1.0, -1.5 to -0.5; P<0.001). No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%; P=0.891).
CONCLUSIONS
Twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.
TRIAL REGISTRATION
Clinicaltrials.gov NCT02765581.",2020,"CONCLUSIONS
Twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura.","['acupuncture naive patients with episodic migraine without aura', '150 randomised patients (mean age 36.5 (SD 11.4) years; 123 (82%) women), 147 were included in the full analysis set', 'Seven hospitals in China, 5 June 2016 to 15 November 2018', '150 acupuncture naive patients with episodic migraine without aura']","['Manual acupuncture versus sham acupuncture and usual care', 'manual acupuncture at true acupuncture points plus usual care, 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care, or usual care alone over 8 weeks', 'manual acupuncture', 'sham acupuncture, manual acupuncture']","['migraine attacks', 'migraine days', 'mean number of attacks', 'mean number of migraine days', 'severe adverse events', 'proportion of patients perceiving needle penetration', 'Change in migraine days and migraine attacks']","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0338480', 'cui_str': 'Migraine without Aura'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.414558,"CONCLUSIONS
Twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura.","[{'ForeName': 'Shabei', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China.'}, {'ForeName': 'Minghuan', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Wuhan No.1 Hospital / Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, Hubei, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Scientific Research Management, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, Hubei, China.'}, {'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': ""Department of Neurology, Xiangyang No.1 People's Hospital, Hubei University of Medicine, Xiangyang, Hubei, China.""}, {'ForeName': 'Huitao', 'Initials': 'H', 'LastName': 'Jing', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Hospital of Huangshi, Huangshi, Hubei, China.'}, {'ForeName': 'Guangying', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Fengxia', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibustion, Wuhan 430065, Hubei, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibustion, Wuhan 430065, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m697']
470,31515154,"Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostate cancers: a randomised, open-label, phase 1-2 trial.","BACKGROUND
Taxane-platinum combinations have shown promising activity in metastatic castration-resistant prostate cancers in single-group clinical studies but not in randomised trials. Distinct biological subsets of the disease might derive the greatest benefit from the addition of platinum. We aimed to determine whether adding carboplatin to cabazitaxel would improve the outcomes of men with metastatic castration-resistant prostate cancer.
METHODS
We did a phase 1-2, open label, randomised study at two centres in men with progressive metastatic castration-resistant prostate cancer. In phase 1, patients received intravenous cabazitaxel 20-25 mg/m 2 and intravenous carboplatin area under the curve (AUC) 3-4 mg/mL per min every 21 days. The maximum tolerated dose was defined as the highest dose cohort studied in which one of six or fewer patients experienced a dose-limiting toxicity. In phase 2, patients were randomly assigned (1:1) centrally by a computerised algorithm to intravenous cabazitaxel 25 mg/m 2 with or without intravenous carboplatin AUC 4 mg/mL per min. All patients received growth factor support and oral prednisone 10 mg daily. The primary endpoints were the maximum tolerated dose of the combination in phase 1 and investigator-assessed progression-free survival in phase 2. This trial is registered at ClinicalTrials.gov, number NCT01505868.
FINDINGS
Between Aug 17, 2012, and May 11, 2015, nine patients completed phase 1 as planned, and 160 were randomly assigned to cabazitaxel (n=79) or cabazitaxel plus carboplatin (n=81) in phase 2. During phase I, grade 3 adverse events were anaemia (n=2), fatigue (n=1), thrombocytopenia (n=1), hypomagnesaemia (n=1), diarrhoea (n=1), hypokalaemia (n=1), anorexia (n=1), and dehydration (n=1), and no grade 4 adverse events occurred. No dose-limiting toxicities were observed, therefore, a maximum tolerated dose of cabazitaxel of 25 mg/m 2 and carboplatin of AUC 4 mg/mL per min was selected for phase 2. At a median follow-up of 31·0 months (IQR 20·5-37·1), the combination improved the median progression-free survival from 4·5 months (95% CI 3·5-5·7) to 7·3 months (95% CI 5·5-8·2; hazard ratio 0·69, 95% CI 0·50-0·95, p=0·018). In the phase 2 study, the most common grade 3-5 adverse events were fatigue (7 [9%] of 79 in the cabazitaxel group vs 16 [20%] of 81 in the combination group), anaemia (3 [4%] vs 19 [23%]), neutropenia (3 [4%] vs 13 [16%]), and thrombocytopenia (1 [1%] vs 11 [14%]). There were no treatment-related deaths.
INTERPRETATION
Carboplatin added to cabazitaxel showed improved clinical efficacy compared with cabazitaxel alone for men with metastatic castration-resistant prostate cancer. Although adverse events were more common with the combination, the treatment was safe and generally well tolerated. Our data suggest that taxane-platinum combinations have a clinically beneficial role in advanced prostate cancer and a randomised phase 3 study is planned.
FUNDING
Sanofi Genzyme, University of Texas MD Anderson Cancer Center Prostate Cancer Moon Shot Program, and Solon Scott III Prostate Cancer Research Fund.",2019,"There were no treatment-related deaths.
","['men with metastatic castration-resistant prostate cancer', 'Between Aug 17, 2012, and May 11, 2015', 'men with progressive metastatic castration-resistant prostate cancer', 'men with metastatic castration-resistant prostate cancers']","['Taxane-platinum combinations', 'Carboplatin', 'Cabazitaxel plus carboplatin', 'cabazitaxel', 'cabazitaxel plus carboplatin', 'taxane-platinum combinations', 'intravenous cabazitaxel 20-25 mg/m 2 and intravenous carboplatin', 'carboplatin to cabazitaxel', 'cabazitaxel alone', 'cabazitaxel 25 mg/m 2 with or without intravenous carboplatin AUC 4 mg/mL per min', 'growth factor support and oral prednisone']","['clinical efficacy', 'safe and generally well tolerated', 'thrombocytopenia', 'anaemia', 'anaemia (n=2), fatigue (n=1), thrombocytopenia (n=1), hypomagnesaemia (n=1), diarrhoea (n=1), hypokalaemia (n=1), anorexia (n=1), and dehydration (n=1), and no grade 4 adverse events', 'neutropenia', 'median progression-free survival', 'maximum tolerated dose of the combination in phase 1 and investigator-assessed progression-free survival', 'maximum tolerated dose']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]",,0.212863,"There were no treatment-related deaths.
","[{'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elisabeth I', 'Initials': 'EI', 'LastName': 'Heath', 'Affiliation': 'Department of Oncology, Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Ramesh', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Sei', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Li-Ning-Tapia', 'Affiliation': 'Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shi-Ming', 'Initials': 'SM', 'LastName': 'Tu', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Subudhi', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Thompson', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Troncoso', 'Affiliation': 'Department of Anatomical Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Navin', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Logothetis', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Aparicio', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: aaparicio@mdanderson.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30408-5']
471,31551824,Effects of Naltrexone on Large-Scale Network Interactions in Methamphetamine Use Disorder.,"Naltrexone attenuates craving, and the subjective effects of methamphetamine and extended-release naltrexone (XR-NTX) reduces functional connectivity between regions of the striatum and limbic cortex. Naltrexone modulates neural activity at dopaminergic synapses; however, it is unclear whether naltrexone has an effect on large-scale brain networks. Functional networks interact to coordinate behavior, and as substance-use disorders are associated with an imbalance between reward and cognitive control networks, treatment approaches that target interactive brain systems underlying addiction may be a useful adjunct for behavioral therapies. The objective of this study was to examine the effect of XR-NTX on large-scale brain networks and to determine whether changes in network relationships attenuate drug use, craving, and addiction severity. Thirty-nine participants in or seeking treatment for methamphetamine-use disorder were enrolled in a clinical trial of XR-NTX between May 2013 and March 2015 (Clinicaltrials.gov NCT01822132). Functional magnetic resonance imaging (fMRI) and questionnaires were conducted before and after double-blinded randomization to a 4-week injection of XR-NTX or placebo. In the XR-NTX group, methamphetamine use was reduced along with a decrease in the coupling between executive control (ECN) and default mode (DMN) networks. As decoupling of ECN and DMN networks was associated with change in the severity of dependence, the results suggest that XR-NTX may modulate and enhance ECN attentional resources and suppress DMN self-referential and emotional processing. This study identifies the effect of naltrexone on changes in the intrinsic functional coupling of large-scale brain networks and provides a more systematic understanding of how large-scale networks interact to promote behavioral change in methamphetamine-use disorder.",2019,"In the XR-NTX group, methamphetamine use was reduced along with a decrease in the coupling between executive control (ECN) and default mode (DMN) networks.","['Methamphetamine Use Disorder', 'Thirty-nine participants in or seeking treatment for methamphetamine-use disorder']","['Naltrexone', 'naltrexone', 'XR-NTX or placebo', 'methamphetamine and extended-release naltrexone (XR-NTX', 'methamphetamine', 'XR-NTX', 'Functional magnetic resonance imaging (fMRI']","['ECN attentional resources and suppress DMN self-referential and emotional processing', 'coupling between executive control (ECN) and default mode (DMN) networks', 'network relationships attenuate drug use, craving, and addiction severity', 'Large-Scale Network Interactions']","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0760481', 'cui_str': '(3beta,5alpha,17beta)-17-hydroxyestrane-3-carbonitrile'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",39.0,0.0731272,"In the XR-NTX group, methamphetamine use was reduced along with a decrease in the coupling between executive control (ECN) and default mode (DMN) networks.","[{'ForeName': 'Milky', 'Initials': 'M', 'LastName': 'Kohno', 'Affiliation': 'Department of Psychiatry, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Angelica M', 'Initials': 'AM', 'LastName': 'Morales', 'Affiliation': 'Department of Psychiatry, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Dennis', 'Affiliation': 'Department of Psychiatry, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'McCready', 'Affiliation': 'Department of Psychiatry, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Hoffman', 'Affiliation': 'Department of Psychiatry, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Section of Addiction Medicine, Oregon Health and Science University, Portland, OR, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2019.00603']
472,32267102,Impact of simultaneous subthalamic and nigral stimulation on dysphagia in Parkinson's disease.,"OBJECTIVES
Dysphagia is a frequent and highly relevant symptom in Parkinson's disease (PD) due to high associated morbidity and mortality. To compare the effect of simultaneous stimulation of the subthalamic nucleus (STN) and substantia nigra (SNr) with conventional STN-stimulation on swallowing function in Parkinson's disease.
METHODS
In this controlled, randomized, double-blind, cross-over clinical trial, 15 PD patients were assessed with DBS switched off (STIM OFF), STN-DBS, STN + SNr-DBS. Patients and 32 age-matched healthy controls were examined clinically and by flexible-endoscopic evaluation of swallowing (FEES) to evaluate the swallowing function. The primary endpoint was the assessment of residues, secondary endpoints were penetration/aspiration, leakage, retained pharyngeal secretions, drooling, and assessments of the patient's self-perception of swallowing on a visual analog scale.
RESULTS
Compared with healthy controls PD patients showed significantly more pharyngeal residues in STIM OFF and both DBS modes. Residues or aspiration events were found in 80% of the patients under STN-stimulation. Simultaneous STN + SNr-stimulation had no additional positive effect on objective dysphagia and self-reported swallowing function compared to STN-DBS.
INTERPRETATION
Simultaneous STN + SNr-stimulation seems to have no additional beneficial effects on dysphagia when compared with conventional STN-stimulation, but did not deteriorate the swallowing function. If STN + SNr-stimulation is planned to be applied for the improvement of axial symptoms and gait disorders in PD patients, it can be considered safe in terms of dysphagia.",2020,"Simultaneous STN + SNr-stimulation had no additional positive effect on objective dysphagia and self-reported swallowing function compared to STN-DBS.
","['PD patients', ""dysphagia in Parkinson's disease"", '15 PD patients', 'Patients and 32 age-matched healthy controls', ""Parkinson's disease""]","['simultaneous subthalamic and nigral stimulation', 'flexible-endoscopic evaluation of swallowing (FEES', 'simultaneous stimulation of the subthalamic nucleus (STN) and substantia nigra (SNr) with conventional STN-stimulation']","['objective dysphagia and self-reported swallowing function', 'swallowing function', ""assessment of residues, secondary endpoints were penetration/aspiration, leakage, retained pharyngeal secretions, drooling, and assessments of the patient's self-perception of swallowing on a visual analog scale"", 'Residues or aspiration events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0038590', 'cui_str': 'Substantia nigra structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038427', 'cui_str': 'Bruneomycin'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0227143', 'cui_str': 'Pharyngeal mucus'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",15.0,0.0491266,"Simultaneous STN + SNr-stimulation had no additional positive effect on objective dysphagia and self-reported swallowing function compared to STN-DBS.
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pflug', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Nienstedt', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gulberti', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Eik', 'Initials': 'E', 'LastName': 'Vettorazzi', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Jana-Christiane', 'Initials': 'JC', 'LastName': 'Koseki', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Niessen', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Flügel', 'Affiliation': 'Department of Voice, Speech and Hearing Disorders, Center for Clinical Neurosciences, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Hidding', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Buhmann', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Centre of Neurology, Department for Neurodegenerative Diseases and Hertie-Institute for Clinical Brain Research, Tübingen, 72076, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hamel', 'Affiliation': 'Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Christian K E', 'Initials': 'CKE', 'LastName': 'Moll', 'Affiliation': 'Department of Neurophysiology and Pathophysiology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Pötter-Nerger', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, 20246, Germany.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51027']
473,32267205,"Efficacy and safety of lower dose tenofovir disoproxil fumarate and efavirenz versus standard dose in HIV-infected, antiretroviral-naive adults: a multicentre, randomized, noninferiority trial.","Reduced doses of antiretroviral (ARV) drugs may lower toxicity while preserving efficacy. We aimed to evaluate the efficacy of reduced doses of both tenofovir disoproxil fumarate (TDF) and efavirenz for the treatment of HIV-1 infection. In this open-label, non-inferiority trial, HIV-1-infected antiretroviral-naive adults were randomly assigned to receive either a lower dose anti-retroviral regimen comprised of TDF (200 mg), efavirenz (400 mg), and standard dose lamivudine (300 mg) or the standard dose regimen. The primary endpoint was the proportion of participants with HIV-1 RNA≤ 50 copies/mL at week 48 using a non-inferiority margin of -10%. At week 48, 79 of 92 (85.9%) participants in the lower dose regimen group and 78 of 92 (84.8%) in the standard dose regimen group achieved HIV-1 RNA≤ 50 copies/mL (treatment difference 1.1%, 95% CI -9.1 to 11.3) in the intention-to-treat analysis. Drug-related adverse events occurred more frequently in the participants receiving the standard dose regimen compared with the lower dose one (63.0% vs 80.4%). Changes in estimated glomerular filtration rate and bone mineral density were comparable between the two groups. The non-inferior efficacy and better safety profile of the lower dose ARV regimen support its use as alternative initial therapy for HIV-1 infected patients.",2020,Drug-related adverse events occurred more frequently in the participants receiving the standard dose regimen compared with the lower dose one (63.0% vs 80.4%).,"['HIV-infected, antiretroviral-naive adults', 'patients with HIV-1 infection', 'HIV-1 infection in antiretroviral-naive adults', 'HIV-1-infected antiretroviral-naive adults from 3 centers in China']","['TDF', 'lamivudine', 'tenofovir disoproxil fumarate (TDF) and efavirenz', 'lower-dose tenofovir disoproxil fumarate and efavirenz', 'antiretroviral (ARV', 'efavirenz']","['glomerular filtration rate and bone mineral density', 'Efficacy and safety', 'Drug-related adverse events']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.347007,Drug-related adverse events occurred more frequently in the participants receiving the standard dose regimen compared with the lower dose one (63.0% vs 80.4%).,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Yinzhong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ""Department of Infectious Disease, The Second Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, People's Republic of China.""}, {'ForeName': 'Xicheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Yunnan AIDS Care Center (YNACC), Yunnan Provincial Infectious Disease Hospital, Kunming, People's Republic of China.""}, {'ForeName': 'Renfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhiliang', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': ""Department of Infectious Disease, The Second Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, People's Republic of China.""}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': ""Yunnan AIDS Care Center (YNACC), Yunnan Provincial Infectious Disease Hospital, Kunming, People's Republic of China.""}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Yunnan AIDS Care Center (YNACC), Yunnan Provincial Infectious Disease Hospital, Kunming, People's Republic of China.""}, {'ForeName': 'Jiangrong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Tangkai', 'Initials': 'T', 'LastName': 'Qi', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhenyan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': ""Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai, People's Republic of China.""}]",Emerging microbes & infections,['10.1080/22221751.2020.1752609']
474,32253789,Extending inferences from a randomized trial to a new target population.,"When treatment effect modifiers influence the decision to participate in a randomized trial, the average treatment effect in the population represented by the randomized individuals will differ from the effect in other populations. In this tutorial, we consider methods for extending causal inferences about time-fixed treatments from a trial to a new target population of nonparticipants, using data from a completed randomized trial and baseline covariate data from a sample from the target population. We examine methods based on modeling the expectation of the outcome, the probability of participation, or both (doubly robust). We compare the methods in a simulation study and show how they can be implemented in software. We apply the methods to a randomized trial nested within a cohort of trial-eligible patients to compare coronary artery surgery plus medical therapy versus medical therapy alone for patients with chronic coronary artery disease. We conclude by discussing issues that arise when using the methods in applied analyses.",2020,"In this tutorial, we consider methods for extending causal inferences about time-fixed treatments from a trial to a new target population of nonparticipants, using data from a completed randomized trial and baseline covariate data from a sample from the target population.",['patients with chronic coronary artery disease'],['coronary artery surgery plus medical therapy versus medical therapy alone'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]",[],,0.209977,"In this tutorial, we consider methods for extending causal inferences about time-fixed treatments from a trial to a new target population of nonparticipants, using data from a completed randomized trial and baseline covariate data from a sample from the target population.","[{'ForeName': 'Issa J', 'Initials': 'IJ', 'LastName': 'Dahabreh', 'Affiliation': 'Center for Evidence Synthesis in Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Robertson', 'Affiliation': 'Center for Evidence Synthesis in Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Steingrimsson', 'Affiliation': 'Department of Biostatistics, School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stuart', 'Affiliation': 'Departments of Mental Health, Biostatistics, and Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}]",Statistics in medicine,['10.1002/sim.8426']
475,30928823,Rationale and design of the Mechanistic Substudy of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE): Effects of pitavastatin on coronary artery disease and inflammatory biomarkers.,"BACKGROUND
People with HIV (PWH) have increased cardiovascular events, inflammation, and high-risk coronary atherosclerosis. Statin therapy has been shown to lower the risk of cardiovascular disease (CVD) in the general population, but whether this results from reductions in coronary atherosclerosis and is mediated by decreased inflammation remains unknown.
METHODS
REPRIEVE is a randomized, placebo-controlled trial of pitavastatin calcium (4 mg/day) vs. placebo enrolling at least 7500 PWH between 40-75 years, on antiretroviral therapy (ART), with low to moderate traditional CVD risk. The Mechanistic Substudy of REPRIEVE (A5333s) is co-enrolling 800 participants from 31 US sites. These participants undergo serial contrast enhanced coronary computed tomography angiography (CCTA) and measurements of biomarkers of inflammation and immune activation at baseline and after 2 years of follow-up. The primary objectives are to determine the effects of pitavastatin on noncalcified coronary atherosclerotic plaque (NCP) volume, low attenuation plaque, and positive remodeling and on changes in immune activation and inflammation and to assess relationships between the two. Changes in CAD will be assessed in a standardized fashion by a core lab with expert readers blinded to time points and participant information; immune activation and inflammation assessment is also performed centrally.
RESULTS
To date the Mechanistic Substudy has completed planned enrollment, with 805 participants.
CONCLUSION
This study represents the first large, randomized, CCTA-based assessment of the effects of a primary prevention strategy for CVD on high-risk CAD, immune activation and inflammation among PWH. The study will assess pitavastatin's effects on coronary plaque, and the interrelationship of these changes with biomarkers of immune activation and inflammation in PWH to determine mechanisms of CVD prevention and improved outcomes in this population.",2019,"Statin therapy has been shown to lower the risk of cardiovascular disease (CVD) in the general population, but whether this results from reductions in coronary atherosclerosis and is mediated by decreased inflammation remains unknown.
","['People with HIV (PWH', '805 participants', 'enrolling at least 7500 PWH between 40-75 years, on antiretroviral therapy (ART), with low to moderate traditional CVD risk', '800 participants from 31 US sites']","['Statin therapy', 'pitavastatin', 'pitavastatin calcium', 'placebo']","['noncalcified coronary atherosclerotic plaque (NCP) volume, low attenuation plaque, and positive remodeling and on changes in immune activation and inflammation', 'coronary computed tomography angiography (CCTA) and measurements of biomarkers of inflammation and immune activation', 'coronary artery disease and inflammatory biomarkers']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4517869', 'cui_str': 'Seven thousand five hundred'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C2720023', 'cui_str': 'pitavastatin calcium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2936350', 'cui_str': 'Plaque, Atherosclerotic'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]",800.0,0.237223,"Statin therapy has been shown to lower the risk of cardiovascular disease (CVD) in the general population, but whether this results from reductions in coronary atherosclerosis and is mediated by decreased inflammation remains unknown.
","[{'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA. Electronic address: uhoffmann@mgh.harvard.edu.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Devvora', 'Initials': 'D', 'LastName': 'Olalere', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Adami', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Osborne', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ivanov', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'John Sukumar', 'Initials': 'JS', 'LastName': 'Aluru', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Saeyun', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Arifovic', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Edgar Turner', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, AL.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Alston-Smith', 'Affiliation': 'DAIDS, NIAID, NIH, Bethesda, MD.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Klingman', 'Affiliation': 'DAIDS, NIAID, NIH, Bethesda, MD.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Waclawiw', 'Affiliation': 'National Institutes of Health/National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Tricia H', 'Initials': 'TH', 'LastName': 'Burdo', 'Affiliation': 'Department of Neuroscience, Temple University School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Williams', 'Affiliation': 'Department of Biology, Boston College, Chestnut Hill, MA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'MGH Program in Nutritional Metabolism and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Institutes of Health/National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Cooper-Arnold', 'Affiliation': 'National Institutes of Health/National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'MGH Program in Nutritional Metabolism and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'MGH Program in Nutritional Metabolism and Harvard Medical School, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2019.02.011']
476,30928825,Rationale and design of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE).,"BACKGROUND
Cardiovascular disease (CVD) is more frequent among people with HIV (PWH) and may relate to traditional and nontraditional factors, including inflammation and immune activation. A critical need exists to develop effective strategies to prevent CVD in this population.
METHODS
The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) (A5332) is a prospective, randomized, placebo-controlled trial of a statin strategy for the primary prevention of major adverse cardiovascular events (MACE) in PWH with low to moderate traditional risk. At least 7,500 PWH, 40-75 years of age, on stable antiretroviral therapy, will be randomized to pitavastatin calcium (4 mg/d) or identical placebo and followed for up to 8 years. Participants are enrolled based on the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk score and low-density lipoprotein cholesterol (LDL-C) level with a goal to identify a low- to moderate-risk population who might benefit from a pharmacologic CVD prevention strategy. Potential participants with a risk score ≤ 15% were eligible based on decreasing LDL-C thresholds for increasing risk score >7.5% (LDL-C <190 mg/dL for risk score <7.5%, LDL-C <160 mg/dL for risk score 7.6%-10%, and LDL-C<130 mg/dL for risk score 10.1%-15%). The primary objective is to determine effects on a composite end point of MACE. Formal and independent adjudication of clinical events will occur using standardized criteria. Key secondary end points include effects on MACE components, all-cause mortality, specified non-CVD events, AIDS and non-AIDS events, and safety.
RESULTS
To date, REPRIEVE has enrolled >7,500 participants at approximately 120 sites across 11 countries, generating a diverse and representative population of PWH to investigate the primary objective of the trial.
CONCLUSIONS
REPRIEVE is the first trial investigating a primary CVD prevention strategy in PWH. REPRIEVE will inform the field of the efficacy and safety of a statin strategy among HIV-infected participants on antiretroviral therapy and provide critical information on CVD mechanisms and non-CVD events in PWH.",2019,"(A5332) is a prospective, randomized, placebo-controlled trial of a statin strategy for the primary prevention of major adverse cardiovascular events (MACE) in PWH with low to moderate traditional risk.","['Potential participants with a risk score ≤ 15% were eligible based on decreasing', 'people with HIV (PWH', 'HIV (REPRIEVE', 'Participants are enrolled based on the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk score and low-density lipoprotein cholesterol (LDL-C) level with a goal to identify a low- to moderate-risk population who might benefit from a pharmacologic CVD prevention strategy', 'has enrolled >7,500 participants at approximately 120 sites across 11 countries, generating a diverse and representative population of PWH to investigate the primary objective of the trial', 'primary prevention of major adverse cardiovascular events (MACE) in PWH with low to moderate traditional risk']","['MACE', 'pitavastatin calcium', 'identical placebo', 'placebo']","['LDL-C thresholds for increasing risk score', 'MACE components, all-cause mortality, specified non-CVD events, AIDS and non-AIDS events, and safety']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C2720023', 'cui_str': 'pitavastatin calcium'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.199733,"(A5332) is a prospective, randomized, placebo-controlled trial of a statin strategy for the primary prevention of major adverse cardiovascular events (MACE) in PWH with low to moderate traditional risk.","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'MGH Program in Nutritional Metabolism and Harvard Medical School, Boston, MA. Electronic address: sgrinspoon@mgh.harvard.edu.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'MGH Program in Nutritional Metabolism and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Edgar Turner', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, AL.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'MGH Program in Nutritional Metabolism and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles, Division of Infectious Diseases, Los Angeles, CA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Inc., Montgomery, AL.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Waclawiw', 'Affiliation': 'National Institutes of Health/National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Alston-Smith', 'Affiliation': 'DAIDS, NIAID, NIH, Bethesda, MD.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Cooper-Arnold', 'Affiliation': 'National Institutes of Health/National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Klingman', 'Affiliation': 'DAIDS, NIAID, NIH, Bethesda, MD.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Institutes of Health/National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2018.12.016']
477,30920878,"Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma: An Open-Label, Multicenter, Phase III Randomized Trial.","PURPOSE
Prophylactic irradiation to the chest wall after diagnostic or therapeutic procedures in patients with malignant pleural mesothelioma (MPM) has been a widespread practice across Europe, although the efficacy of this treatment is uncertain. In this study, we aimed to determine the efficacy of prophylactic radiotherapy in reducing the incidence of chest wall metastases (CWM) after a procedure in MPM.
METHODS
After undergoing a chest wall procedure, patients with MPM were randomly assigned to receive prophylactic radiotherapy (within 42 days of the procedure) or no radiotherapy. Open thoracotomies, needle biopsies, and indwelling pleural catheters were excluded. Prophylactic radiotherapy was delivered at a dose of 21 Gy in three fractions over three consecutive working days, using a single electron field adapted to maximize coverage of the tract from skin surface to pleura. The primary outcome was the incidence of CWM within 6 months from random assignment, assessed in the intention-to-treat population. Stratification factors included epithelioid histology and intention to give chemotherapy.
RESULTS
Between July 30, 2012, and December 12, 2015, 375 patients were recruited from 54 centers and randomly assigned to receive prophylactic radiotherapy (n = 186) or no prophylactic radiotherapy (n = 189). Participants were well matched at baseline. No significant difference was seen in the incidence of CWM at 6 months between the prophylactic radiotherapy and no radiotherapy groups (no. [%]: 6 [3.2] v 10 [5.3], respectively; odds ratio, 0.60; 95% CI, 0.17 to 1.86; P = .44). Skin toxicity was the most common radiotherapy-related adverse event in the prophylactic radiotherapy group, with 96 patients (51.6%) receiving grade 1; 19 (10.2%), grade 2; and 1 (0.5%) grade 3 radiation dermatitis (Common Terminology Criteria for Adverse Events, version 4.0).
CONCLUSION
There is no role for the routine use of prophylactic irradiation to chest wall procedure sites in patients with MPM.",2019,"No significant difference was seen in the incidence of CWM at 6 months between the prophylactic radiotherapy and no radiotherapy groups (no. [%]: 6 [3.2] v 10 [5.3], respectively; odds ratio, 0.60; 95% CI, 0.17 to 1.86; P = .44).","['Between July 30, 2012, and December 12, 2015, 375 patients were recruited from 54 centers', 'patients with malignant pleural mesothelioma (MPM', 'patients with MPM', 'chest wall metastases (CWM) after a procedure in MPM', 'After undergoing a chest wall procedure, patients with MPM', 'Patients With Malignant Pleural Mesothelioma']","['Prophylactic Irradiation of Tracts', 'prophylactic radiotherapy (n = 186) or no prophylactic radiotherapy', 'Prophylactic radiotherapy', 'prophylactic radiotherapy', 'no radiotherapy']","['incidence of CWM', 'grade 3 radiation dermatitis', 'intention-to-treat population', 'Skin toxicity']","[{'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}, {'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0405907', 'cui_str': 'Chest wall procedure (procedure)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",375.0,0.117238,"No significant difference was seen in the incidence of CWM at 6 months between the prophylactic radiotherapy and no radiotherapy groups (no. [%]: 6 [3.2] v 10 [5.3], respectively; odds ratio, 0.60; 95% CI, 0.17 to 1.86; P = .44).","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Bayman', 'Affiliation': '1 The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Appel', 'Affiliation': '2 Lancashire Teaching Hospitals National Health Service Foundation Trust, Preston, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ashcroft', 'Affiliation': '1 The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': '3 Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': '4 University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Darlison', 'Affiliation': '5 University Hospitals of Leicester National Health Service Trust, Leicester, United Kingdom.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Edwards', 'Affiliation': '6 Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Veni', 'Initials': 'V', 'LastName': 'Ezhil', 'Affiliation': '7 Royal Surrey County Hospital, National Health Service Foundation Trust, Guildford, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gilligan', 'Affiliation': '8 Cambridge University Hospital National Health Service Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hatton', 'Affiliation': '6 Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Apurna', 'Initials': 'A', 'LastName': 'Jegannathen', 'Affiliation': '9 University Hospitals of North Midlands National Health Service Trust, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Talal', 'Initials': 'T', 'LastName': 'Mansy', 'Affiliation': '10 South Tees Hospitals National Health Service Foundation Trust, Middlesbrough, United Kingdom.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Peake', 'Affiliation': '5 University Hospitals of Leicester National Health Service Trust, Leicester, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pemberton', 'Affiliation': '1 The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Rintoul', 'Affiliation': '11 Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Snee', 'Affiliation': '12 Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom.'}, {'ForeName': 'W David', 'Initials': 'WD', 'LastName': 'Ryder', 'Affiliation': '1 The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': '13 Manchester University National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': '1 The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01678']
478,31001264,Field Testing Integrated Interventions for Schistosomiasis Elimination in the People's Republic of China: Outcomes of a Multifactorial Cluster-Randomized Controlled Trial.,"Despite significant progress, China faces the challenge of re-emerging schistosomiasis transmission in currently controlled areas due, in part, to the presence of a range of animal reservoirs, notably water buffalo and cattle, which can harbor Schistosoma japonicum infections. Environmental, ecological and social-demographic changes in China, shown to affect the distribution of oncomelanid snails, can also impact future schistosomiasis transmission. In light of their importance in the S. japonicum , lifecycle, vaccination has been proposed as a means to reduce the excretion of egg from cattle and buffalo, thereby interrupting transmission from these reservoir hosts to snails. A DNA-based vaccine (SjCTPI) our team developed showed encouraging efficacy against S. japonicum in Chinese water buffaloes. Here we report the results of a double-blind cluster randomized trial aimed at determining the impact of a combination of the SjCTPI bovine vaccine (given as a prime-boost regimen), human mass chemotherapy and snail control on the transmission of S. japonicum in 12 selected administrative villages around the Dongting Lake in Hunan province. The trial confirmed human praziquantel treatment is an effective intervention at the population level. Further, mollusciciding had an indirect ~50% efficacy in reducing human infection rates. Serology showed that the SjCTPI vaccine produced an effective antibody response in vaccinated bovines, resulting in a negative correlation with bovine egg counts observed at all post-vaccination time points. Despite these encouraging outcomes, the effect of the vaccine in preventing human infection was inconclusive. This was likely due to activities undertaken by the China National Schistosomiasis Control Program, notably the treatment, sacrifice or removal of bovines from trial villages, over which we had no control; as a result, the trial design was compromised, reducing power and contaminating outcome measures. This highlights the difficulties in undertaking field trials of this nature and magnitude, particularly over a long period, and emphasizes the importance of mathematical modeling in predicting the potential impact of control intervention measures. A transmission blocking vaccine targeting bovines for the prevention of S. japonicum with the required protective efficacy would be invaluable in tandem with other preventive intervention measures if the goal of eliminating schistosomiasis from China is to become a reality.",2019,A DNA-based vaccine (SjCTPI) our team developed showed encouraging efficacy against S. japonicum in Chinese water buffaloes.,['12 selected administrative villages around the Dongting Lake in Hunan province'],"['human mass chemotherapy and snail control', 'Field Testing Integrated Interventions', 'SjCTPI bovine vaccine', 'SjCTPI vaccine', 'vaccine', 'DNA-based vaccine (SjCTPI']","['effective antibody response', 'human infection rates']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3853310', 'cui_str': 'Snail'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",12.0,0.0627481,A DNA-based vaccine (SjCTPI) our team developed showed encouraging efficacy against S. japonicum in Chinese water buffaloes.,"[{'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Williams', 'Affiliation': 'School of Public Health, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Yue-Sheng', 'Initials': 'YS', 'LastName': 'Li', 'Affiliation': 'Molecular Parasitology Laboratory, Infectious Diseases Division, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Darren J', 'Initials': 'DJ', 'LastName': 'Gray', 'Affiliation': 'School of Public Health, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Zheng-Yuan', 'Initials': 'ZY', 'LastName': 'Zhao', 'Affiliation': 'World Health Organisation Collaborating Centre for Research and Control of Schistosomiasis in Lake Region, Hunan Institute of Parasitic Diseases, Yueyang, China.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Harn', 'Affiliation': 'Department of Infectious Diseases, College of Veterinary Medicine and Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, GA, United States.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Shollenberger', 'Affiliation': 'Department of Biological Sciences, Old Dominion University, Norfolk, VA, United States.'}, {'ForeName': 'Sheng-Ming', 'Initials': 'SM', 'LastName': 'Li', 'Affiliation': 'World Health Organisation Collaborating Centre for Research and Control of Schistosomiasis in Lake Region, Hunan Institute of Parasitic Diseases, Yueyang, China.'}, {'ForeName': 'Xinglin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'World Health Organisation Collaborating Centre for Research and Control of Schistosomiasis in Lake Region, Hunan Institute of Parasitic Diseases, Yueyang, China.'}, {'ForeName': 'Zeng', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Chinese Centre for Disease Control and Prevention, National Institute of Parasitic Diseases, Shanghai, China.'}, {'ForeName': 'Jia-Gang', 'Initials': 'JG', 'LastName': 'Guo', 'Affiliation': 'World Health Organisation Collaborating Centre for Research and Control of Schistosomiasis in Lake Region, Hunan Institute of Parasitic Diseases, Yueyang, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'World Health Organisation Collaborating Centre for Research and Control of Schistosomiasis in Lake Region, Hunan Institute of Parasitic Diseases, Yueyang, China.'}, {'ForeName': 'Yu-Lan', 'Initials': 'YL', 'LastName': 'Dong', 'Affiliation': 'World Health Organisation Collaborating Centre for Research and Control of Schistosomiasis in Lake Region, Hunan Institute of Parasitic Diseases, Yueyang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Centre of Cell and Molecular Biology Experiment, Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'School of Public Health, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Driguez', 'Affiliation': 'Molecular Parasitology Laboratory, Infectious Diseases Division, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Harvie', 'Affiliation': 'Molecular Parasitology Laboratory, Infectious Diseases Division, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Molecular Parasitology Laboratory, Infectious Diseases Division, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Allen G', 'Initials': 'AG', 'LastName': 'Ross', 'Affiliation': 'Menzies Health Institute, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'McManus', 'Affiliation': 'Molecular Parasitology Laboratory, Infectious Diseases Division, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}]",Frontiers in immunology,['10.3389/fimmu.2019.00645']
479,32256621,Comparison of the Effect of High and Low Doses of Adrenocorticotropic Hormone (ACTH) in the Management of Infantile Spasms.,"Objectives
Infantile spasms can have irrecoverable adverse effects on a child's brain. Adrenocorticotropic hormone (ACTH) is the most common first-line medication for the treatment of infantile spasms. However, the suitable dose and duration of treatment continue to be debated among specialists. Since high doses of ACTH, which are commonly used, can produce more side effects, lower doses are preferred. The aim of this study was to determine the effect and extent of complications caused by high and low doses of ACTH in children with infantile spasms.
Materials & Methods
This clinical trial was performed on 32 infants with infantile spasms, aged 1.5-18 months. The subjects were divided into high- and low-dose ACTH groups. Treatment continued for two months. The therapeutic effects and complications were then compared over 18 months.
Results
The results indicated no significant difference between the groups in terms of the short-term prognosis of convulsions, final prognosis of patients with spasm relapse, EEG changes after treatment, and post-treatment development of hypertension. On the other hand, there was a significant difference in the frequency distribution of restlessness intensity and becoming Cushingoid, which were more frequent in the high-dose group.
Conclusion
The results indicated that high- and low-dose ACTH are equally effective in controlling spasms, yet the low dose causes fewer side effects.",2020,"The results indicated no significant difference between the groups in terms of the short-term prognosis of convulsions, final prognosis of patients with spasm relapse, EEG changes after treatment, and post-treatment development of hypertension.","['Infantile Spasms', 'children with infantile spasms', '32 infants with infantile spasms, aged 1.5-18 months']","['Adrenocorticotropic hormone (ACTH', 'High and Low Doses of Adrenocorticotropic Hormone (ACTH', 'ACTH']","['therapeutic effects and complications', 'frequency distribution of restlessness intensity', 'short-term prognosis of convulsions, final prognosis of patients with spasm relapse, EEG changes']","[{'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",32.0,0.0271126,"The results indicated no significant difference between the groups in terms of the short-term prognosis of convulsions, final prognosis of patients with spasm relapse, EEG changes after treatment, and post-treatment development of hypertension.","[{'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Fayyazi', 'Affiliation': 'Department of Pediatrics Neurology, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Reihane', 'Initials': 'R', 'LastName': 'Eslamian', 'Affiliation': 'Department of Pediatrics Neurology, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khajeh', 'Affiliation': 'Department of Pediatrics Neurology, Children and Adolescents Health Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Instructor of Pediatrics Nursing, Nahavand School of Allied Medical Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Iranian journal of child neurology,[]
480,32256625,Levetiracetam (levebel) Versus Carbamazepine Monotherapy for Focal Epilepsy in Children: A randomized clinical trial.,"Objective
This study aimed at comparing the effect of a newly approved drug leveitiracetam (LEV) versus carbamazepine (CBZ) in the treatment of childhood focal epilepsy.
Methods & Materials
The study population included newly diagnosed children with focal epilepsy (1-16 years old) referring to the Pediatric Neurology Ward of Quaem Hospital, Mashhad, Iran from May 2013 to March 2014. The subjects were randomly treated with LEV or CBZ. Patients were followed for seizure control and drug side effects throughout six months. We assessed liver function and complete blood count for all patients through one month and they were asked about significant side effects, such as drowsiness، restlessness, and skin reaction. Eventually, they were assigned in two groups (n=25) receiving LEV and CBZ.
Results
In our study, two cases in the LEV group were excluded because of severe agitation. Relapsing seizures were observed in 3 (13%) and 10 (40%) patients in LEV and CBZ groups, respectively. The seizure was not repeated in 15 cases (60%) in the CBZ group and 20 cases (87%) in the LEV group. The results of the Chi-squared test showed significant differences in the responses to treatment between the groups ( P =0.03). Agitation was the most prevalent complication in the LEV group, whereas drowsiness was more common in the CBZ group. Fortunately, liver enzyme dysfunction and blood cell disturbances were not observed in the subjects.
Conclusion
According to the findings, there were significant differences in controlling seizures between two groups that indicated the effectiveness of LEV (87%) in the suppression of focal seizure.",2020,"Agitation was the most prevalent complication in the LEV group, whereas drowsiness was more common in the CBZ group.","['newly diagnosed children with focal epilepsy (1-16 years old) referring to the Pediatric Neurology Ward of Quaem Hospital, Mashhad, Iran from May 2013 to March 2014', 'Focal Epilepsy in Children', 'childhood focal epilepsy']","['Carbamazepine Monotherapy', 'LEV or CBZ', 'newly approved drug leveitiracetam (LEV) versus carbamazepine (CBZ', 'CBZ', 'LEV and CBZ', 'Levetiracetam (levebel']","['severe agitation', 'drowsiness، restlessness, and skin reaction', 'liver enzyme dysfunction and blood cell disturbances', 'seizure', 'drowsiness', 'controlling seizures', 'Relapsing seizures', 'liver function and complete blood count']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0279167', 'cui_str': 'Pediatric neurology'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0023556', 'cui_str': 'Levamisole'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0005773', 'cui_str': 'Blood cell'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}]",,0.04721,"Agitation was the most prevalent complication in the LEV group, whereas drowsiness was more common in the CBZ group.","[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Akhondian', 'Affiliation': 'Department Of Pediatric Neurology , Quaem Hospital ,Mashad University of Medical Sciences ,Mashad ,Iran.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Ashrafzadeh', 'Affiliation': 'Department Of Pediatric Neurology , Quaem Hospital ,Mashad University of Medical Sciences ,Mashad ,Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Eslamiyeh', 'Affiliation': 'Department Of of Pediatric Neurology, Shahid Sadoughi University of Medical Science ,Yazd, Iran.'}]",Iranian journal of child neurology,[]
481,31006815,Neonatal Vitamin A Supplementation and Vitamin A Status Are Associated with Gut Microbiome Composition in Bangladeshi Infants in Early Infancy and at 2 Years of Age.,"BACKGROUND
Infancy is a crucial period for establishing the intestinal microbiome. This process may be influenced by vitamin A (VA) status because VA affects intestinal immunity and epithelial integrity, factors that can, in turn, modulate microbiome development.
OBJECTIVES
The aim of this study was to determine if neonatal VA supplementation (VAS) affected the abundance of Bifidobacterium, a beneficial commensal, or of Proteobacteria, a phylum containing enteric pathogens, in early (6-15 wk) or late (2 y) infancy. Secondary objectives were to determine if VAS affected the abundance of other bacterial taxa, and to determine if VA status assessed by measuring plasma retinol was associated with bacterial abundance.
METHODS
Three hundred and six Bangladeshi infants were randomized by sex and birthweight status (above/below median) to receive 1 VA dose (50,000 IU) or placebo within 48 h of birth. Relative abundance at the genus level and above was assessed by 16S rRNA gene sequencing. A terminal restriction fragment-length polymorphism assay was used to identify Bifidobacterium species and subspecies at 6 wk.
RESULTS
Linear regression showed that Bifidobacterium abundance in early infancy was lower in boys (median, 1st/3rd quartiles; 0.67, 0.52/0.78) than girls (0.73, 0.60/0.80; P = 0.003) but that boys receiving VAS (0.69, 0.55/0.78) had higher abundance than boys receiving placebo (0.65, 0.44/0.77; P = 0.039). However this difference was not seen in girls (VAS 0.71, 0.54/0.80; placebo 0.75, 0.63/0.81; P = 0.25). VAS did not affect Proteobacteria abundance. Sex-specific associations were also seen for VA status, including positive associations of plasma retinol with Actinobacteria (the phylum containing Bifidobacterium) and Akkermansia, another commensal with possible health benefits, for girls in late infancy.
CONCLUSIONS
Better VA status in infancy may influence health both in infancy and later in life by promoting the establishment of a healthy microbiota. This postulated effect of VA may differ between boys and girls. This trial was registered at clinicaltrials.gov as NCT02027610.",2019,"However this difference was not seen in girls (VAS 0.71, 0.54/0.80; placebo 0.75, 0.63/0.81; P = 0.25).","['Three hundred and six Bangladeshi infants', 'Bangladeshi Infants in Early Infancy and at 2 Years of Age']","['Neonatal Vitamin A Supplementation and Vitamin A', 'neonatal VA supplementation (VAS', 'placebo', 'VAS']",['Bifidobacterium abundance'],"[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",306.0,0.466046,"However this difference was not seen in girls (VAS 0.71, 0.54/0.80; placebo 0.75, 0.63/0.81; P = 0.25).","[{'ForeName': 'M Nazmul', 'Initials': 'MN', 'LastName': 'Huda', 'Affiliation': 'Nutrition Department.'}, {'ForeName': 'Shaikh M', 'Initials': 'SM', 'LastName': 'Ahmad', 'Affiliation': 'Immunobiology, Nutrition and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology.'}, {'ForeName': 'Diana H', 'Initials': 'DH', 'LastName': 'Taft', 'Affiliation': 'Department of Food Science and Technology.'}, {'ForeName': 'Md J', 'Initials': 'MJ', 'LastName': 'Alam', 'Affiliation': 'Immunobiology, Nutrition and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Afsana', 'Initials': 'A', 'LastName': 'Khanam', 'Affiliation': 'Immunobiology, Nutrition and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Rubhana', 'Initials': 'R', 'LastName': 'Raqib', 'Affiliation': 'Immunobiology, Nutrition and Toxicology Laboratory, Infectious Diseases Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Stephensen', 'Affiliation': 'Nutrition Department.'}]",The Journal of nutrition,['10.1093/jn/nxz034']
482,31150315,Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12.,"PURPOSE
Total neoadjuvant therapy is a new paradigm for rectal cancer treatment. Optimal scheduling of preoperative chemoradiotherapy (CRT) and chemotherapy remains to be established.
PATIENTS AND METHODS
We conducted a multicenter, randomized, phase II trial using a pick-the-winner design on the basis of the hypothesis of an increased pathologic complete response (pCR) of 25% after total neoadjuvant therapy compared with standard 15% after preoperative CRT. Patients with stage II or III rectal cancer were assigned to group A for induction chemotherapy using three cycles of fluorouracil, leucovorin, and oxaliplatin before fluorouracil/oxaliplatin CRT (50.4 Gy) or to group B for consolidation chemotherapy after CRT. Secondary end points included toxicity, compliance, and surgical morbidity.
RESULTS
Of the 311 patients enrolled, 306 patients were evaluable (156 in group A and 150 in group B). CRT-related grade 3 or 4 toxicity was lower (37% v 27%) and compliance with CRT higher in group B (91%, 78%, and 76% v 97%, 87%, and 93% received full-dose radiotherapy, concomitant fluorouracil, and concomitant oxaliplatin in groups A and B, respectively); 92% versus 85% completed all induction/consolidation chemotherapy cycles, respectively. The longer interval between completion of CRT and surgery in group B (median 90 v 45 days in group A) did not increase surgical morbidity. A pCR in the intention-to-treat population was achieved in 17% in group A and in 25% in group B. Thus, only group B ( P < .001), but not group A ( P = .210), fulfilled the predefined statistical hypothesis.
CONCLUSION
Up-front CRT followed by chemotherapy resulted in better compliance with CRT but worse compliance with chemotherapy compared with group A. Long-term follow-up will assess whether improved pCR in group B translates to better oncologic outcome.",2019,"B. Thus, only group B ( P < .001), but not group A ( P = .210), fulfilled the predefined statistical hypothesis.
","['311 patients enrolled', 'Patients with stage II or III rectal cancer', 'Locally Advanced Rectal Cancer', '306 patients were evaluable']","['chemotherapy', 'induction chemotherapy', 'fluorouracil, leucovorin, and oxaliplatin before fluorouracil/oxaliplatin CRT', 'radiotherapy, concomitant fluorouracil, and concomitant oxaliplatin', 'Chemoradiotherapy Plus Induction or Consolidation Chemotherapy', 'preoperative chemoradiotherapy (CRT) and chemotherapy']","['CRT-related grade 3 or 4 toxicity', 'toxicity, compliance, and surgical morbidity', 'surgical morbidity', 'pathologic complete response (pCR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",311.0,0.0747186,"B. Thus, only group B ( P < .001), but not group A ( P = .210), fulfilled the predefined statistical hypothesis.
","[{'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Allgäuer', 'Affiliation': 'Barmherzige Brüder Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Polat', 'Affiliation': 'University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Klautke', 'Affiliation': 'Poliklinik Chemnitz, Chemnitz, Germany.'}, {'ForeName': 'Gerhard G', 'Initials': 'GG', 'LastName': 'Grabenbauer', 'Affiliation': 'DiaCura, Klinikum Coburg, Coburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuhnt', 'Affiliation': 'University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brunner', 'Affiliation': 'University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Anca-Ligia', 'Initials': 'AL', 'LastName': 'Grosu', 'Affiliation': 'University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Wolff', 'Initials': 'W', 'LastName': 'Schmiegel', 'Affiliation': 'Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Jacobasch', 'Affiliation': 'Praxis of Haematology and Oncology, Dresden, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': 'German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Schlenska-Lange', 'Affiliation': 'German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Flentje', 'Affiliation': 'University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christoph-Thomas', 'Initials': 'CT', 'LastName': 'Germer', 'Affiliation': 'University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwarzbach', 'Affiliation': 'Klinikum Frankfurt Höchst, Frankfurt, Germany.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Paolucci', 'Affiliation': 'Ketteler Krankenhaus, Offenbach, Germany.'}, {'ForeName': 'Wolf O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00308']
483,32067625,Propranolol Reduces Portal Vein Diameter in Schistosomal Liver Disease with Portal Hypertension: A Prospective Cohort Study.,"Hepatosplenic schistosomiasis (HSS) complicates portal hypertension, leading to life-threatening variceal bleeding. Variceal bleeding is associated with increased portal vein diameter (PVD). Beta-blockers prevent variceal bleeding. It is unclear whether beta-blockers such as propranolol can reduce PVD in HSS. We aimed to explore the effect of propranolol on PVD in HSS. A longitudinal study was conducted at the University Teaching Hospital, Zambia, as an extension of a clinical trial of rifaximin undertaken to test the hypothesis that rifaximin could reduce bacterial translocation in HSS. We randomized 85 adults to either rifaximin and standard care, or propranolol-based standard care only for 42 days. We then followed up all the patients on propranolol up to day 180. We used ultrasound to measure PVD at baseline and day 180. The primary outcome was reduction in PVD. Beta-blockade and splenic size reduction were secondary outcomes. Portal vein diameter reduced after 180 days of propranolol therapy from median 12 mm (interquartile range (IQR): 11-14) to median 10 mm (IQR: 9-13) ( P < 0.001). The pulse rate reduced from baseline median 70 beats/minute (IQR: 66-80) to 65 beats/minute (IQR: 60-70) by day 180 ( P = 0.006). Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6-11) to 12 g/dL (10-14) ( P < 0.001). Splenic size remained unchanged. Propranolol led to the reduction in PVD over 180 days. This suggests that ultrasound could be useful in monitoring response and compliance to beta-blockers, especially in resource-constraint areas where portal hypertension measurement facilities are unavailable.",2020,Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6-11) to 12 g/dL (10-14) ( P < 0.001).,"['Schistosomal Liver with Portal Hypertension', '85 adults to either']","['Propranolol', 'rifaximin and standard care, or propranolol-based standard care', 'Beta-blockers', 'propranolol']","['reduction in PVD', 'Portal vein diameter', 'Hemoglobin levels', 'Beta-blockade and splenic size reduction', 'portal vein diameter (PVD', 'Splenic size', 'variceal bleeding', 'Variceal bleeding', 'Portal Vein Diameter', 'pulse rate']","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}]",85.0,0.142688,Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6-11) to 12 g/dL (10-14) ( P < 0.001).,"[{'ForeName': 'Edford', 'Initials': 'E', 'LastName': 'Sinkala', 'Affiliation': 'Department of Internal Medicine, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vinikoor', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Kanekwa', 'Initials': 'K', 'LastName': 'Zyambo', 'Affiliation': 'Department of Internal Medicine, Tropical Gastroenterology and Nutritional Group, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Besa', 'Affiliation': 'Department of Internal Medicine, Tropical Gastroenterology and Nutritional Group, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bright', 'Initials': 'B', 'LastName': 'Nsokolo', 'Affiliation': 'Department of Internal Medicine, Tropical Gastroenterology and Nutritional Group, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine, Queen Mary University of London, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0452']
484,32151879,Redundant visual signals reduce the intensity of alcohol impairment.,"BACKGROUND
Humans interact with multiple stimuli across several modalities each day. The ""redundant signal effect"" refers to the observation that individuals respond more quickly to stimuli when information is presented as multisensory, redundant stimuli (e.g., aurally and visually), rather than as a single stimulus presented to either modality alone. Studies of alcohol effects on human performance show that alcohol induced impairment is reduced when subjects respond to redundant multisensory stimuli. However, redundant signals do not need to involve multisensory stimuli to facilitate behavior as studies have shown facilitating effects by redundant unisensory signals that are delivered to the ""same sensory"" (e.g., two visual or two auditory signals).
METHODS
The current study examined the degree to which redundant visual signals would reduce alcohol impairment and compared the magnitude of this effect with that produced by redundant multisensory signals. On repeated test sessions, participants (n = 20) received placebo or 0.65 g/kg alcohol and performed a two-choice reaction time task that measured how quickly participants responded to four different signal conditions. The four conditions differed by the modality of the target presentation: visual, auditory, multisensory, and unisensory.
RESULTS
Alcohol slowed performance in all conditions and reaction times were generally faster in the redundant signal conditions. Both multisensory and unisensory redundant signals reduced the impairing effects of alcohol compared with single signals.
CONCLUSIONS
These findings indicate that the ability of redundant signals to counteract alcohol impairment does not require multisensory input. Duplicate signals to the same modality can also reduce alcohol impairment.",2020,"RESULTS
Alcohol slowed performance in all conditions and reaction times were generally faster in the redundant signal conditions.",[],['placebo'],"['modality of the target presentation: visual, auditory, multisensory, and unisensory', 'alcohol impairment', 'intensity of alcohol impairment']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.0208763,"RESULTS
Alcohol slowed performance in all conditions and reaction times were generally faster in the redundant signal conditions.","[{'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': ""D'Agostino"", 'Affiliation': 'Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fillmore', 'Affiliation': 'Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY, 40506-0044, USA. Electronic address: fillmore@uky.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107945']
485,31831167,Effect of patient education on palliative care knowledge and acceptability of outpatient palliative care services among gynecologic oncology patients: A randomized controlled trial.,"OBJECTIVES
A randomized control trial (RCT) to estimate the effect of an interventional video on improving palliative care knowledge, acceptability and attendance to outpatient services in gynecologic oncology patients.
METHODS
Women receiving treatment for gynecologic malignancy recruited at an academic tertiary care center were randomized to: palliative care educational video or non-directive cancer center video. The primary outcome was referral to palliative care. Function and knowledge were assessed using the Functional Assessment of Cancer Therapy and the Palliative Care Knowledge Scale. Data analyses were performed using t-tests, Wilcoxon rank sum or Fisher's exact tests with significance level of α = 0.05.
RESULTS
111 women were enrolled. Demographic characteristics were equally distributed between groups with respect to age, race, cancer, and stage. There was no statistical difference in knowledge scores or in referral to palliative care between the patients that watched the educational versus control video (29% vs. 27%; p = .79). Secondary analysis showed a statistically significant increase in utilization of palliative care services compared to historic institutional data (8.8% to 31.5%; p ≤.001). Further, those referred had significantly worse baseline functional scores.
CONCLUSIONS
Use of a palliative care educational video did not increase knowledge or acceptability of palliative services within this RCT. However, the rate of patients referred to palliative care tripled compared to historic rates. Further studies should investigate whether discussion regarding palliative care services alone may increase desire for referral, and if use of Fact-G scores may identify patients in greatest need of services.",2020,There was no statistical difference in knowledge scores or in referral to palliative care between the patients that watched the educational versus control video (29% vs. 27%; p = .79).,"['111 women were enrolled', 'gynecologic oncology patients', 'Women receiving treatment for gynecologic malignancy recruited at an academic tertiary care center']","['interventional video', 'outpatient palliative care services', 'patient education', 'palliative care educational video or non-directive cancer center video']","['knowledge or acceptability of palliative services', 'palliative care knowledge, acceptability and attendance to outpatient services', 'knowledge scores', 'referral to palliative care', 'utilization of palliative care services']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service (qualifier value)'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0086751', 'cui_str': 'Outpatient Services'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service (qualifier value)'}]",111.0,0.104673,There was no statistical difference in knowledge scores or in referral to palliative care between the patients that watched the educational versus control video (29% vs. 27%; p = .79).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Graul', 'Affiliation': ""Department of Gynecologic Oncology, St. Luke's University Health System, Bethlehem, PA, United States of America. Electronic address: Ashley.graul@sluhn.org.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Haggerty', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stickley', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Palliative Care, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bogner', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ko', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.11.023']
486,32213484,Computerised speech and language therapy can help people with aphasia find words following a stroke.,"The studyPalmer R, Dimairo M, Cooper C, et al. Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multicentre, single-blinded, randomised controlled trial. Lancet Neurol 2019;18:821-33.This project was funded by the NIHR Health Technology Assessment Programme (project number 12/21/01) and the Tavistock Trust for Aphasia.To read the full NIHR Signal, go to: https://discover.dc.nihr.ac.uk/content/signal-000864/after-a-stroke-computerised-speech-and-language-therapy-can-help-people-find-words.",2020,"Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multicentre, single-blinded, randomised controlled trial. ",['patients with chronic aphasia post-stroke'],"['Lancet Neurol', 'Computerised speech and language therapy', 'usual care or attention control (Big CACTUS', 'Self-managed, computerised speech and language therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0777169', 'cui_str': 'Lancet (physical object)'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0330340', 'cui_str': 'Cactus'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",[],,0.0723576,"Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multicentre, single-blinded, randomised controlled trial. ","[{'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Cook', 'Affiliation': 'Bazian, Economist Intelligence Unit healthcare, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Davidson', 'Affiliation': 'Wessex Institute, University of Southampton, Southampton, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Bazian, Economist Intelligence Unit healthcare, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m520']
487,31269007,High-Intensity Interval Training Is Feasible in Women at High Risk for Breast Cancer.,"PURPOSE
This trial aimed to demonstrate the feasibility of high-intensity interval training (HIIT) in postmenopausal, overweight/obese women at high risk of invasive breast cancer and to explore HIIT on changes in cardiorespiratory fitness (CRF), body weight, and body mass index (BMI) compared with moderate-intensity continuous training (MICT) and usual care (UC).
METHODS
Forty-four women were randomized to HIIT, MICT, or UC for a 12-wk, thrice weekly, supervised exercise intervention. HIIT included a 5-min warm-up at 50%-70% HRpeak, four cycles of 4 min at 90%-100% HRpeak, followed by 3 min at 50%-70% HRpeak. MICT consisted of 41 min at 60%-70% HRpeak. Feasibility was assessed by consent, adherence, compliance, and retention rates. CRF, body weight, and BMI were measured at baseline and end of study. Repeated-measures linear mixed models were used to assess within- and between-group differences.
RESULTS
Average age was 63.9 ± 8.8 yr. BMI was 30.9 ± 5.7 kg·m. Participants completed 90% and 89% of HIIT and MICT workouts, respectively, with 100% compliance to the exercise prescriptions. No serious adverse events were reported. Compared with MICT and UC, HIIT exhibited improvements in change in treadmill time (101 s greater than MICT, and 125 s greater than UC, respectively, P < 0.001). Compared with UC, HIIT exhibited improvement in changes in absolute and relative V˙O2peak (a 0.15-L·min increase, P = 0.005, and a 2.3-mL·kg⋅min increase, P = 0.004). There were no significant differences between groups for body weight or BMI (P > 0.05).
CONCLUSIONS
HIIT is feasible, safe, and seems to promote greater improvements in CRF compared with MICT and UC in women at high risk for breast cancer.",2019,"Compared to MICT and UC, HIIT exhibited improvements in change in treadmill time (101 seconds greater than MICT, and 125 seconds greater than UC, respectively, p<0.001).","['Women at High Risk for Breast Cancer', 'post-menopausal, overweight/obese women at high-risk of invasive breast cancer', 'women at high risk for breast cancer', 'Forty-four women']","['MICT', 'high-intensity interval training (HIIT', 'moderate-intensity continuous training (MICT) and usual care (UC', 'High-Intensity Interval Training', 'supervised exercise intervention', 'HIIT, MICT or UC']","['body weight or BMI (p>0.05', 'BMI', 'cardiorespiratory fitness (CRF), body weight, and body mass index (BMI', 'CRF, body weight and BMI', 'consent, adherence, compliance and retention rates', 'treadmill time', 'serious adverse events', 'absolute and relative VO2peak']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4047809', 'cui_str': 'At high risk for breast cancer'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",44.0,0.0702456,"Compared to MICT and UC, HIIT exhibited improvements in change in treadmill time (101 seconds greater than MICT, and 125 seconds greater than UC, respectively, p<0.001).","[{'ForeName': 'Adriana M', 'Initials': 'AM', 'LastName': 'Coletta', 'Affiliation': 'Cancer Control and Population Sciences Program, Huntsman Cancer Institute, Salt Lake City, UT.'}, {'ForeName': 'Abenaa M', 'Initials': 'AM', 'LastName': 'Brewster', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Minxing', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Therese B', 'Initials': 'TB', 'LastName': 'Bevers', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basen-Engquist', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Gilchrist', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002048']
488,31600598,A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.,"OBJECTIVES
Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.
METHODS
The study was performed in 60 healthy adults. In Part 1, eight non-SA carriers were randomised to groups of four subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel or 2.0mg/g 2% gel. In Part 2, 52 persistent SA carriers were randomised to groups of 13 subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel, 2.0mg/g 2% gel, 0.5mg/g 4% gel or 4% viscosified placebo gel. Plasma pharmacokinetic and pharmacodynamic studies were performed. Antistaphylococcal activity was assessed as the presence/absence of SA and by quantification of colonisation using a semiquantitative scale (SA score).
RESULTS
56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the pharmacokinetic population and 48/60 the pharmacodynamic population. There was no measurable systemic absorption of XF-73. XF-73 treatment was associated with rapid reduction in SA score in all subjects. The most common treatment-emergent adverse events (TEAEs) were rhinorrhoea and nasal dryness (15.5% each in Parts 1 and 2). TEAEs were mild and resolved spontaneously.
CONCLUSION
XF-73 was well tolerated with minimal side effects at doses of 0.5mg/g 2% gel and 2.0mg/g 2% gel. These findings support further development of XF-73.",2019,"CONCLUSION
XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","['2 dosing cohorts, and enrolled 60 healthy adults', '56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population', '52 healthy persistent SA carriers', 'Staphylococcus aureus', 'healthy volunteers']","['XF-73 in concentrations of 0.5\u2009mg/g 2% gel and 2\u2009mg/g 2% gel, respectively', 'XF-73', 'XF-73 (0.5\u2009mg/g 2% gel, 2\u2009mg/g 2% gel and 0.5\u2009mg/g 4% gel) or a 4% viscosified placebo gel']","['systemic absorption of XF-73', 'safety and local tolerability', 'Anti-staphylococcal activity', 'rhinorrhea and nasal dryness', 'SA scores', 'Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3850076', 'cui_str': 'Systemic Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0287411,"CONCLUSION
XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Yendewa', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. Electronic address: gay7@case.edu.'}, {'ForeName': 'J McLeod', 'Initials': 'JM', 'LastName': 'Griffiss', 'Affiliation': 'ClinicalRM, Hinckley, OH, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pathology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Fulton', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': ""O'Riordan"", 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Department of Pediatrics, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin and Associates, Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.09.017']
489,31165754,Effects of system response delays on elderly humans' cognitive performance in a virtual training scenario.,"Observed influences of system response delay in spoken human-machine dialogues are rather ambiguous and mainly focus on perceived system quality. Studies that systematically inspect effects on cognitive performance are still lacking, and effects of individual characteristics are also often neglected. Building on benefits of cognitive training for decelerating cognitive decline, this Wizard-of-Oz study addresses both issues by testing 62 elderly participants in a dialogue-based memory training with a virtual agent. Participants acquired the method of loci with fading instructional guidance and applied it afterward to memorizing and recalling lists of German nouns. System response delays were randomly assigned, and training performance was included as potential mediator. Participants' age, gender, and subscales of affinity for technology (enthusiasm, competence, positive and negative perception of technology) were inspected as potential moderators. The results indicated positive effects on recall performance with higher training performance, female gender, and less negative perception of technology. Additionally, memory retention and facets of affinity for technology moderated increasing system response delays. Participants also provided higher ratings in perceived system quality with higher enthusiasm for technology but reported increasing frustration with a more positive perception of technology. Potential explanations and implications for the design of spoken dialogue systems are discussed.",2019,Observed influences of system response delay in spoken human-machine dialogues are rather ambiguous and mainly focus on perceived system quality.,"[""elderly humans' cognitive performance in a virtual training scenario"", '62 elderly participants in a dialogue-based memory training with a virtual agent']",['cognitive training'],['recall performance'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729377', 'cui_str': 'Memory Training'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}]",[],62.0,0.0196474,Observed influences of system response delay in spoken human-machine dialogues are rather ambiguous and mainly focus on perceived system quality.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wirzberger', 'Affiliation': 'Max Planck Research Group ""Rationality Enhancement"", Max Planck Institute for Intelligent Systems, Max-Planck-Ring 4, 72076, Tübingen, Germany. maria.wirzberger@tuebingen.mpg.de.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmidt', 'Affiliation': 'Computer Engineering, Faculty of Computer Science, TU Chemnitz, Straße der Nationen 62, 09111, Chemnitz, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Georgi', 'Affiliation': 'Information Science, Faculty of Languages, Literature and Culture, University of Regensburg, Universitätsstraße 31, 93053, Regensburg, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Hardt', 'Affiliation': 'Computer Engineering, Faculty of Computer Science, TU Chemnitz, Straße der Nationen 62, 09111, Chemnitz, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Brunnett', 'Affiliation': 'Computer Graphics and Visualization, Faculty of Computer Science, TU Chemnitz, Straße der Nationen 62, 09111, Chemnitz, Germany.'}, {'ForeName': 'Günter Daniel', 'Initials': 'GD', 'LastName': 'Rey', 'Affiliation': 'Psychology of Learning with Digital Media, Faculty of Humanities, TU Chemnitz, Straße der Nationen 12, 09111, Chemnitz, Germany.'}]",Scientific reports,['10.1038/s41598-019-44718-x']
490,30922733,"Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study.","BACKGROUND
Despite improvements in multidisciplinary management, patients with biliary tract cancer have a poor outcome. Only 20% of patients are eligible for surgical resection with curative intent, with 5-year overall survival of less than 10% for all patients. To our knowledge, no studies have described a benefit of adjuvant therapy. We aimed to determine whether adjuvant capecitabine improved overall survival compared with observation following surgery for biliary tract cancer.
METHODS
This randomised, controlled, multicentre, phase 3 study was done across 44 specialist hepatopancreatobiliary centres in the UK. Eligible patients were aged 18 years or older and had histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer who had undergone a macroscopically complete resection (which includes liver resection, pancreatic resection, or, less commonly, both) with curative intent, and an Eastern Cooperative Oncology Group performance status of less than 2. Patients who had not completely recovered from previous surgery or who had previous chemotherapy or radiotherapy for biliary tract cancer were also excluded. Patients were randomly assigned 1:1 to receive oral capecitabine (1250 mg/m 2 twice daily on days 1-14 of a 21-day cycle, for eight cycles) or observation commencing within 16 weeks of surgery. Treatment was not masked, and allocation concealment was achieved with a computerised minimisation algorithm that stratified patients by surgical centre, site of disease, resection status, and performance status. The primary outcome was overall survival. As prespecified, analyses were done by intention to treat and per protocol. This study is registered with EudraCT, number 2005-003318-13.
FINDINGS
Between March 15, 2006, and Dec 4, 2014, 447 patients were enrolled; 223 patients with biliary tract cancer resected with curative intent were randomly assigned to the capecitabine group and 224 to the observation group. The data cutoff for this analysis was March 6, 2017. The median follow-up for all patients was 60 months (IQR 37-60). In the intention-to-treat analysis, median overall survival was 51·1 months (95% CI 34·6-59·1) in the capecitabine group compared with 36·4 months (29·7-44·5) in the observation group (adjusted hazard ratio [HR] 0·81, 95% CI 0·63-1·04; p=0·097). In a protocol-specified sensitivity analysis, adjusting for minimisation factors and nodal status, grade, and gender, the overall survival HR was 0·71 (95% CI 0·55-0·92; p=0·010). In the prespecified per-protocol analysis (210 patients in the capecitabine group and 220 in the observation group), median overall survival was 53 months (95% CI 40 to not reached) in the capecitabine group and 36 months (30-44) in the observation group (adjusted HR 0·75, 95% CI 0·58-0·97; p=0·028). In the intention-to-treat analysis, median recurrence-free survival was 24·4 months (95% CI 18·6-35·9) in the capecitabine group and 17·5 months (12·0-23·8) in the observation group. In the per-protocol analysis, median recurrence-free survival was 25·9 months (95% CI 19·8-46·3) in the capecitabine group and 17·4 months (12·0-23·7) in the observation group. Adverse events were measured in the capecitabine group only, and of the 213 patients who received at least one cycle, 94 (44%) had at least one grade 3 toxicity, the most frequent of which were hand-foot syndrome in 43 (20%) patients, diarrhoea in 16 (8%) patients, and fatigue in 16 (8%) patients. One (<1%) patient had grade 4 cardiac ischaemia or infarction. Serious adverse events were observed in 47 (21%) of 223 patients in the capecitabine group and 22 (10%) of 224 patients in the observation group. No deaths were deemed to be treatment related.
INTERPRETATION
Although this study did not meet its primary endpoint of improving overall survival in the intention-to-treat population, the prespecified sensitivity and per-protocol analyses suggest that capecitabine can improve overall survival in patients with resected biliary tract cancer when used as adjuvant chemotherapy following surgery and could be considered as standard of care. Furthermore, the safety profile is manageable, supporting the use of capecitabine in this setting.
FUNDING
Cancer Research UK and Roche.",2019,"No deaths were deemed to be treatment related.
","['patients with resected biliary tract cancer', 'patients with biliary tract cancer', 'resected biliary tract cancer (BILCAP', '44 specialist hepatopancreatobiliary centres in the UK', 'Between March 15, 2006, and Dec 4, 2014, 447 patients were enrolled; 223 patients with biliary tract cancer resected with curative intent', 'Eligible patients were aged 18 years or older and had histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer who had undergone a macroscopically complete resection (which includes liver resection, pancreatic resection, or, less commonly, both) with curative intent, and an Eastern Cooperative Oncology Group performance status of less than 2', 'Patients who had not completely recovered from previous surgery or who had previous chemotherapy or radiotherapy for biliary tract cancer', 'registered with EudraCT, number 2005-003318-13']","['capecitabine', 'Capecitabine', 'oral capecitabine ', 'adjuvant capecitabine']","['Adverse events', '5-year overall survival', 'diarrhoea', 'grade 4 cardiac ischaemia or infarction', 'median overall survival', 'grade 3 toxicity', 'overall survival', 'median recurrence-free survival', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocellular Carcinoma'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0153452', 'cui_str': 'Cancer of Gallbladder'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}]",447.0,0.426977,"No deaths were deemed to be treatment related.
","[{'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Primrose', 'Affiliation': 'Department of Surgery, University of Southampton, Southampton, UK. Electronic address: j.n.primrose@soton.ac.uk.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Fox', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'University of Liverpool and Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'Hassan Z', 'Initials': 'HZ', 'LastName': 'Malik', 'Affiliation': 'Aintree University Hospital, Liverpool, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Prasad', 'Affiliation': 'Department of Surgery, University of Leeds, Leeds, UK.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Mirza', 'Affiliation': ""University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Women's Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anthony', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Corrie', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'University of Bristol Hospitals NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Finch-Jones', 'Affiliation': 'University of Bristol Hospitals NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Imperial Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ross', 'Affiliation': ""Guys and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wall', 'Affiliation': 'Lothian University Hospitals NHS Trust, Edinburgh, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Jeff T R', 'Initials': 'JTR', 'LastName': 'Evans', 'Affiliation': 'Department of Oncology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Stocken', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Raaj', 'Initials': 'R', 'LastName': 'Praseedom', 'Affiliation': 'Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Yuk Ting', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Department of General Surgery, University College London Hospital, London, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Neoptolemos', 'Affiliation': 'Department of Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'University Hospitals Southampton, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'Health Economics Analysis Team, University of Southampton, Southampton, UK.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Health Economics Analysis Team, University of Southampton, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden NHS Trust, London, UK.'}, {'ForeName': 'O James', 'Initials': 'OJ', 'LastName': 'Garden', 'Affiliation': 'Department of Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Stubbs', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, University College London, London, UK. Electronic address: j.bridgewater@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30915-X']
491,32253895,Effect of acupuncture in physiological parameters and endurance running performance.,"BACKGROUND
Few studies have examined the effect of acupuncture (AC) treatment in aerobic capacity and endurance performance in healthy adults. Thus, the aim of the present study was to evaluate the effects of AC on selected physiological parameters and 3 km running performance.
METHODS
Twenty-four healthy subjects with low to moderate aerobic capacity participated in the study and randomly assigned in two groups: AC group (ACG - N.=14) and control group (CG - N.=10). The subjects completed an incremental test to exhaustion and a 3 km race on a treadmill to evaluate their physiological responses and endurance running performance respectively, prior and after 4 weeks (8 sessions, twice a week) of acupuncture treatment.
RESULTS
AC treatment had a significant main effect in T3km [F(1, 21)=7.173, P=0.014, partial η2=0.255], as well as in VT [F(1, 21)=8.476, P=0.008, partial η2=0.288] and HRmax@3km [F(1, 21)=4.930, P=0.038, partial η2=0.190], after controlling for the effect of the pre-test, while no other significant main effects were detected.
CONCLUSIONS
Healthy physically active adults significantly improved their endurance running performance after 4 weeks of AC treatment. This is mainly due to the enhancement of the speed corresponding with VT, comparing with their baseline values.",2020,"RESULTS
AC treatment had a significant main effect in T3km [F(1, 21)=7,173, p=0,014, partial η2=0,255], as well as in VT [F(1, 21)=8,476, p=0,008, partial η2=0,288] and HRmax@3km [F(1, 21)=4,930, p=0,038, partial η2=0,190], after controlling for the effect of the pre-test, while no other significant main effects were detected.
","['healthy adults', 'Healthy physically active adults', 'Twenty four healthy subjects with low to moderate aerobic capacity participated in the study and randomly assigned in two groups']","['AC group (ACG - N=14) and control group (CG - N=10', 'acupuncture treatment', 'acupuncture', 'acupuncture (AC']","['physiological parameters and endurance running performance', 'endurance running performance', 'aerobic capacity and endurance performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0050397', 'cui_str': 'acceleratory factor from growth hormone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",24.0,0.0638065,"RESULTS
AC treatment had a significant main effect in T3km [F(1, 21)=7,173, p=0,014, partial η2=0,255], as well as in VT [F(1, 21)=8,476, p=0,008, partial η2=0,288] and HRmax@3km [F(1, 21)=4,930, p=0,038, partial η2=0,190], after controlling for the effect of the pre-test, while no other significant main effects were detected.
","[{'ForeName': 'Angela Α', 'Initials': 'AΑ', 'LastName': 'Tsopanidou', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece - angelatsopanidou@hotmail.com.'}, {'ForeName': 'Prokopios Ε', 'Initials': 'PΕ', 'LastName': 'Chatzakis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece.'}, {'ForeName': 'Panagiotis V', 'Initials': 'PV', 'LastName': 'Drimalas', 'Affiliation': 'Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania.'}, {'ForeName': 'Ioannis S', 'Initials': 'IS', 'LastName': 'Stavridis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece.'}, {'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Dallas', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece.'}, {'ForeName': 'Elias G', 'Initials': 'EG', 'LastName': 'Zacharogiannis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10325-6']
492,32253896,Effects of different multicomponent training methods on functional parameters in physically-active older women.,"BACKGROUND
Negative functionality changes are among the effects of aging. The multicomponent training performed on conventional machines or with new implements and features directed to daily activities is strongly recommended among attenuation strategies. However, the efficiency of both types of training is not yet clear in the recent literature. The aim was to compare the effects of different multicomponent training methods on functional parameters in older women.
METHODS
Thirty-seven volunteers were randomly selected into the functional multicomponent training (MFT: N.=15), traditional multicomponent training (MTT: N.=14) and control group (CG: N.=8). They were assessed in the tests: Six-Minute Walk Test (6MWT), Ten-Minute Fast Walking Test (10FWT), Timed Up and Go test (TUG), Functional Reach Test (FRT), Ankle Test (AKT), Sit To Stand Modified test (STSM), and quality of life (QOL). ANOVA (3×2) followed by the Bonferroni post-hoc was used, adopting P≤0.05 for statistical significance.
RESULTS
When compared pre-post values, MFT showed significant differences in all functional tests evaluated (AKT: P<0.01; STSM: P<0.01; FRT: P<0.01; QOF: P<0.01; 10FWT: P<0.01; 6MWT: P<0.01; TUG: P<0.05). In the same comparison, MTT showed a significant change in all tests (AKT: P<0.01; STSM: P<0.01; FRT: P<0.01; QOF: P<0.05; 6MWT: P≤0.05; TUG: P<0.05) except 10FWT. When compared to CG, MFT showed a significant difference in all walking tests and MTT showed a better performance in 10FWT and TUG.
CONCLUSIONS
Both experimental protocols were effective to improve functional parameters in older women. However, the MFT was performed better in most tests that required efficiency in gait ability.",2020,"When compared to CG, MFT showed a significant difference in all walking tests and MTT showed a better performance in 10FWT and TUG.
","['Thirty-seven volunteers', 'older women', 'physically active older women']","['multicomponent training methods', 'MFT', 'functional multicomponent training (MFT: n=15), traditional multicomponent training (MTT: n=14) and control group (CG']","['tests: 6-minute walk test (6MWT), 10-minute fast walking test (10FWT), time up and go (TUG), functional reach test (FRT), ankle test (AKT), sit to stand modified (STSM) and quality of life (QOF', 'functional parameters']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0647210', 'cui_str': 'monooxyethylene trimethylolpropane tristearate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",37.0,0.0254339,"When compared to CG, MFT showed a significant difference in all walking tests and MTT showed a better performance in 10FWT and TUG.
","[{'ForeName': 'Leandro H', 'Initials': 'LH', 'LastName': 'Brandão', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil - leeo.henriquee01@gmail.com.'}, {'ForeName': 'Antônio G', 'Initials': 'AG', 'LastName': 'Resende-Neto', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil.'}, {'ForeName': 'Iohanna G', 'Initials': 'IG', 'LastName': 'Fernandes', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Vasconcelos', 'Affiliation': 'Postgraduate Program of Physiology, Federal University of Sergipe, São Cristovão, Brazil.'}, {'ForeName': 'Albernon C', 'Initials': 'AC', 'LastName': 'Nogueira', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil.'}, {'ForeName': 'Marzo E', 'Initials': 'ME', 'LastName': 'Da Silva-Grigoletto', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10327-X']
493,32187417,"An examination of changes in skeletal muscle thickness, echo intensity, strength and soreness following resistance exercise.","It is suggested that changes in echo intensity (EI) measured through ultrasound can detect muscle swelling. However, changes in EI have never been examined relative to a non-exercise control following naïve exposure to exercise.
PURPOSE
Examine the changes in muscle thickness (MT), EI and isometric strength (ISO) before, immediately after, and 24, and 48 hr following biceps curls.
METHODS
Twenty-seven non-resistance-trained individuals visited the laboratory four times. During visit 1, paperwork was completed and strength was measured. During visit 2, MT and ISO were measured before four sets of curls. Additional measures were taken immediately after exercise, as well as 24 and 48 hr post. Results are displayed as means (SD).
RESULTS
For MT, there was an interaction (p < .001). For the experimental condition, MT increased from pre [2.88(0.64) cm] to post [3.27(0.67) cm] and remained elevated 48 hr post. There were no changes for MT in the control arm. In the experimental arm, EI increased from pre [22.9(9.6) AU] to post [29.1(12.3) AU] exercise and returned to baseline by 24 hr. For the control condition, EI was different between pre [24.8(10.2) AU] and 48 hr [21.5(10.7) AU]. The change in EI in the experimental condition was greater than the control condition immediately post (p = .039) and at 48 hr (p = .016). For ISO, there was an interaction (p < .001). In the experimental condition, ISO decreased from pre [40.6(14.7) Nm)] to post [24.8(9.4) Nm] and remained depressed.
CONCLUSIONS
Exercise produced a swelling response, which was elevated 48 hr post. Despite a sustained increase in MT, EI was only elevated immediately post exercise.",2020,The change in EI in the experimental condition was greater than the control condition immediately post (p = .039) and at 48 hr (p = .016).,['27 non-resistance trained individuals visited the laboratory 4 times'],[],"['swelling response', 'muscle thickness (MT), EI and isometric strength (ISO', 'Skeletal Muscle Thickness, Echo Intensity, Strength, and Soreness Following Resistance Exercise', 'MT, EI']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",[],"[{'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0690848,The change in EI in the experimental condition was greater than the control condition immediately post (p = .039) and at 48 hr (p = .016).,"[{'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Yitzchaki', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Wenyuan G', 'Initials': 'WG', 'LastName': 'Zhu', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Tayla E', 'Initials': 'TE', 'LastName': 'Kuehne', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Ecaterina', 'Initials': 'E', 'LastName': 'Vasenina', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Dankel', 'Affiliation': 'Exercise Physiology Laboratory, Department of Health and Exercise Science, Rowan University, Glassboro, NJ, USA.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Buckner', 'Affiliation': 'USF Muscle Lab, Exercise Science Program, University of South Florida, Tampa, FL, USA.'}]",Clinical physiology and functional imaging,['10.1111/cpf.12630']
494,31169651,Bilateral subcostal transversus abdominis plane block does not improve the postoperative analgesia provided by multimodal analgesia after laparoscopic cholecystectomy: A randomised placebo-controlled trial.,"BACKGROUND
Laparoscopic cholecystectomy might be considered minor surgery, but it may result in severe postoperative pain. Subcostal transversus abdominis plane (TAP) block, which produces long-lasting supra-umbilical parietal analgesia, might improve analgesia after laparoscopic cholecystectomy.
OBJECTIVE
We investigated whether subcostal TAP block would reduce opioid consumption and pain after laparoscopic cholecystectomy in patients provided with multimodal analgesia.
DESIGN
A randomised, placebo-controlled, double-blind study.
SETTING
The study was conducted at a university teaching hospital from December 2017 to June 2018.
PATIENTS
Sixty patients scheduled for laparoscopic cholecystectomy were included. Anaesthesia and postoperative analgesia (etoricoxib, paracetamol, ketamine and dexamethasone) were standardised.
INTERVENTION
After induction of anaesthesia, patients were allocated into two groups: ultrasound-guided bilateral subcostal TAP block with 20 ml of levobupivacaine 0.375% and epinephrine 5 μg ml or 0.9% saline with epinephrine 5 μg ml.
MAIN OUTCOME MEASURES
Opioid consumption in the recovery room and during the first 24 h after surgery were recorded. Postoperative somatic and visceral pain scores, fatigue and nausea were measured. Intra-operative end-tidal concentrations of sevoflurane (FETSEVO) were also recorded.
RESULTS
Twenty-four hour postoperative opioid consumption were similar in both groups: 21.2 mg (95% CI 15.3 to 27.1) vs. 25.2 (95% CI 15.1 to 35.5) oral morphine equivalent in the levobupivacaine and 0.9% saline groups, respectively; P = 0.48. No significant between-group differences were observed with regards to parietal (P = 0.56) and visceral (P = 0.50) pain scores, fatigue and nausea. FETSEVO was slightly lower in the levobupivacaine group (P < 0.01).
CONCLUSION
Subcostal TAP block does not improve the analgesia provided by multimodal analgesia after laparoscopic cholecystectomy. It allows for a small reduction in intra-operative sevoflurane requirements.
TRIAL REGISTRATION
NCT0339153.",2019,"No significant between-group differences were observed with regards to parietal (P = 0.56) and visceral (P = 0.50) pain scores, fatigue and nausea.","['Sixty patients scheduled for', 'The study was conducted at a university teaching hospital from December 2017 to June 2018', 'patients provided with multimodal analgesia']","['Bilateral subcostal transversus abdominis plane block', 'placebo', 'sevoflurane (FETSEVO', 'levobupivacaine', 'subcostal TAP block', 'laparoscopic cholecystectomy', 'Subcostal transversus abdominis plane (TAP) block', 'Laparoscopic cholecystectomy', 'Anaesthesia and postoperative analgesia (etoricoxib, paracetamol, ketamine and dexamethasone', 'ultrasound-guided bilateral subcostal TAP block with 20\u200aml of levobupivacaine 0.375% and epinephrine 5\u200aμg\u200aml or 0.9% saline with epinephrine 5\u200aμg\u200aml', 'Subcostal TAP block']","['postoperative opioid consumption', 'Opioid consumption in the recovery room and during the first 24\u200ah after surgery', 'pain scores, fatigue and nausea', 'opioid consumption and pain', 'Postoperative somatic and visceral pain scores, fatigue and nausea']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0442184', 'cui_str': 'Subcostal (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517455', 'cui_str': '0.375 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234245', 'cui_str': 'Visceral Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.590609,"No significant between-group differences were observed with regards to parietal (P = 0.56) and visceral (P = 0.50) pain scores, fatigue and nausea.","[{'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Houben', 'Affiliation': 'From the Department of Anaesthesiology (AMH, A-SJM, AK, JLJ), Service of Abdominal Surgery, CHU Liège, University of Liège, Domaine du Sart Tilman, Liège, Belgium (OMD).'}, {'ForeName': 'Anne-Sophie J', 'Initials': 'AJ', 'LastName': 'Moreau', 'Affiliation': ''}, {'ForeName': 'Olivier M', 'Initials': 'OM', 'LastName': 'Detry', 'Affiliation': ''}, {'ForeName': 'Abdourahamane', 'Initials': 'A', 'LastName': 'Kaba', 'Affiliation': ''}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Joris', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001028']
495,32270722,"Reply: Re: Yildiz BP, Bayraktaroglu M, Gunen H. Bronchodilator efficacy of tiotropium/formoterol (18/12 μg once daily via a discair inhaler), tiotropium alone (18 μg by handihaler) or combined with formoterol (12 μg twice daily by aerolizer) in adults with moderate-to-severe stable COPD. Curr Med Res Opin. 2019;35(12):2187-2196.",,2020,,['adults with moderate-to-severe stable COPD'],"['tiotropium/formoterol ', 'tiotropium alone (18\u2009μg by Handihaler) or combined with formoterol']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",[],,0.195448,,"[{'ForeName': 'Birsen Pinar', 'Initials': 'BP', 'LastName': 'Yildiz', 'Affiliation': 'Department of Pulmonary Medicine, University of Health Sciences, Yedikule Research and Training Centre for Chest Diseases and Thoracic Surgery Istanbul, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Bayraktaroglu', 'Affiliation': 'Department of Pulmonary Medicine, University of Health Sciences, Yedikule Research and Training Centre for Chest Diseases and Thoracic Surgery Istanbul, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Gunen', 'Affiliation': 'Sureyyapasa Training and Research Centre for Chest Diseases and Thoracic Surgery, Istanbul, Turkey.'}]",Current medical research and opinion,['10.1080/03007995.2020.1754187']
496,32270774,Comparison of the effect of 1-day and 2-day low residue diets on the quality of bowel preparation before colonoscopy.,"Background/Aim
Low residue diet (LRD) has a similar quality of bowel preparation with clear liquid diet before colonoscopy, but improved patient tolerance. However, the optimal LRD duration is still controversial. In this study, we have compared the effect of a 1-day LRD and 2-day LRD on the quality of bowel preparation and patient tolerance.
Patients and Methods
Our prospective, randomized, single-blind trial, single-blind, trial compared two dietary regimens administered the day before colonoscopy. All patients were administered PEG-ES and simethicone for bowel preparation. The primary outcome measure was bowel preparation quality. The secondary outcome measures were insertion time, withdrawal time, polyp detection rate, patient tolerance, and willingness to use the same diet for bowel preparation again. Bowel preparation quality was evaluated using the Boston bowel preparation scale (BBPS). Patient tolerance was evaluated using a hunger-comfort scale.
Results
There was no significant difference in bowel preparation quality between the 2 groups. The 1-day LRD group had a BBPS score of 6.48 ± 1.59 points, while the 2-day LRD group had a score of 6.42 ± 1.06 points (P > 0.05). The groups reported similar colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores). The numbers of patients who reported that compliance as easy or very easy were 126 (78.2%) in the 1-day group versus 88 (55.0%) in the 2 day group (P < 0.05) and the numbers who were willing to use the diet again in the future were 154 (95.7%) in the 1-day group versus 131 (81.9%) in the 2 day group (P < 0.05).
Conclusion
LRD duration (1 day or 2 days) had no significant effect on bowel preparation quality. Patients in the 1-day LRD group had higher tolerance and satisfaction levels than patients in the 2-day LRD group. However, overall satisfaction was higher with the 1-day LRD group than with the 2-day LRD group.",2020,"The groups reported similar colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores).",[],"['Low residue diet (LRD', '1-day and 2-day low residue diets', '1-day LRD and 2-day LRD']","['overall satisfaction', 'Boston bowel preparation scale (BBPS', 'BBPS score', 'insertion time, withdrawal time, polyp detection rate, patient tolerance, and willingness to use the same diet for bowel preparation again', 'Patient tolerance', 'colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores', 'bowel preparation quality', 'tolerance and satisfaction levels', 'quality of bowel preparation', 'Bowel preparation quality']",[],"[{'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0180022', 'cui_str': 'Colonoscope'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.099055,"The groups reported similar colonoscope insertion times, withdrawal times, polyp detection rates and patient tolerance scores (hunger-comfort scores).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association,['10.4103/sjg.SJG_471_19']
497,31037789,Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care.,"OBJECTIVE
Adolescents and young adults (AYAs) with cancer are at high risk of negative psychosocial outcomes. Promoting Resilience in Stress Management (PRISM), a novel, brief, skill-based intervention, has demonstrated efficacy in improving psychosocial well-being for AYAs. We utilized data from a recent randomized trial of PRISM versus usual care (UC) to categorize and explore group differences in change trajectories of patient reported outcomes (PROs) over time.
METHODS
One hundred English-speaking AYAs (aged 12-25 years old) with cancer were randomized to PRISM versus UC. At enrollment and 6 months later, AYAs completed validated PROs measuring resilience (Connor-Davidson Resilience Scale [CDRISC-10]), hope (Hope Scale), benefit finding (Benefit and Burden Scale for Children), cancer-specific quality of life (Pediatric Quality of Life [PedsQL] Cancer Module), and distress (Kessler-6). Patient response trajectories were categorized as ""improved,"" ""consistently well,"" ""consistently at risk,"" or ""deteriorated"" using minimal clinically important differences (MCIDs) or established measure cutoffs for all PROs. Positive response trajectories consisted of the first two categories (""improved"" and ""consistently well""), and negative response trajectories consisted of the latter two categories (""consistently at risk"" and ""deteriorated"").
RESULTS
Across all PROs, more patients in the PRISM arm ""improved"" in psychosocial well-being over time, and fewer PRISM recipients ""deteriorated"" over time. Across all PROs, a greater proportion of PRISM participants (vs UC) experienced positive response trajectories. Across all PROs, a greater proportion of UC participants experienced negative response trajectories.
CONCLUSIONS
PRISM shows evidence of both a prevention effect and an intervention effect. Thus, PRISM may serve as a viable prevention and early intervention model for psychosocial care.",2019,"Across all PROs, more patients in the PRISM arm ""improved"" in psychosocial well-being over time, and fewer PRISM recipients ""deteriorated"" over time.","['Adolescents and young adults (AYAs) with cancer', 'One hundred English-speaking AYAs (aged 12-25 years old) with cancer']","['PRISM versus UC', 'PRISM versus usual care (UC']","['PROs measuring resilience (Connor-Davidson Resilience Scale [CDRISC-10]), hope (Hope Scale), benefit finding (Benefit and Burden Scale for Children), cancer-specific quality of life (Pediatric Quality of Life [PedsQL] Cancer Module), and distress (Kessler-6']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",100.0,0.0429357,"Across all PROs, more patients in the PRISM arm ""improved"" in psychosocial well-being over time, and fewer PRISM recipients ""deteriorated"" over time.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lau', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Steineck', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Junkins', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McCauley', 'Affiliation': 'Division of Child Psychiatry, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}]",Psycho-oncology,['10.1002/pon.5098']
498,32265240,"Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial.","INTRODUCTION
Acute kidney injury (AKI) is a frequent complication after cardiac surgery with adverse short-term and long-term outcomes. Although prevention of AKI (PrevAKI) is strongly recommended, the optimal strategy is uncertain. The Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommended a bundle of supportive measures in high-risk patients. In a single-centre trial, we recently demonstrated that the strict implementation of the KDIGO bundle significantly reduced the occurrence of AKI after cardiac surgery. In this feasibility study, we aim to evaluate whether the study protocol can be implemented in a multicentre setting in preparation for a large multicentre trial.
METHODS AND ANALYSIS
We plan to conduct a prospective, observational survey followed by a randomised controlled, multicentre, multinational clinical trial including 280 patients undergoing cardiac surgery with cardiopulmonary bypass. The purpose of the observational survey is to explore the adherence to the KDIGO recommendations in routine clinical practice. The second phase is a randomised controlled trial. The objective is to investigate whether the trial protocol is implementable in a large multicentre, multinational setting. The primary endpoint of the interventional part is the compliance rate with the protocol. Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes.
ETHICS AND DISSEMINATION
The PrevAKI multicentre study has been approved by the leading Research Ethics Committee of the University of Münster and the respective Research Ethics Committee at each participating site. The results will be used to design a large, definitive trial.
TRIAL REGISTRATION NUMBER
NCT03244514.",2020,"Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes.
ETHICS AND DISSEMINATION
","['patients after cardiac surgery (PrevAKI-multicentre', 'high-risk patients', 'Kidney Disease', '280 patients undergoing cardiac surgery with cardiopulmonary bypass']",[],"['occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality', 'combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes.\nETHICS AND DISSEMINATION', 'occurrence of AKI', 'compliance rate with the protocol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]",[],"[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",280.0,0.211025,"Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes.
ETHICS AND DISSEMINATION
","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Küllmar', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Massoth', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Campos', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Grau Novellas', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Thomson', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haffner', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Arndt', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care, University Hospital Marburg, Marburg, UK.'}, {'ForeName': 'Hinnerk', 'Initials': 'H', 'LastName': 'Wulf', 'Affiliation': 'Anesthesiology & Intensive Care Medicine, Philipps-Universitat Marburg Fachbereich Medizin, Marburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Irqsusi', 'Affiliation': 'Department of Cardiothoracic Surgery, Philipps-Universitat Marburg Fachbereich Medizin, Marburg, Germany.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': 'Intensive Care and Anesthesia Unit, Scientific Institute San Raffaele, Milano, Italy.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Di Prima', 'Affiliation': 'Intensive Care and Anesthesia Unit, Scientific Institute San Raffaele, Milano, Italy.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Garcia Alvarez', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Italiano', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Cegarra SanMartin', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Kunst', 'Affiliation': ""Department of Anesthesia, Critical Care and Pain, King's College London, London, UK.""}, {'ForeName': 'Shrijit', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': ""Department of Anesthesia, Critical Care and Pain, King's College London, London, UK.""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': ""L'Acqua"", 'Affiliation': 'Department of Anesthesia and Critical Care, Centro Cardiologico Monzino IRCCS, Milano, Lombardia, Italy.'}, {'ForeName': 'Eric A J', 'Initials': 'EAJ', 'LastName': 'Hoste', 'Affiliation': 'ICU, Universiteit Gent, Gent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Vandenberghe', 'Affiliation': 'ICU, Universiteit Gent, Gent, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Honore', 'Affiliation': 'Department of Intensive Care, CHU Brugmann, Brussels, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kellum', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lui', 'Initials': 'L', 'LastName': 'Forni', 'Affiliation': 'Department of Intensive Care Medicine, Royal Surrey County Hospital NHS Trust, Guildford, Surrey, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grieshaber', 'Affiliation': 'Department of Cardiac Surgery, Justus Liebig Universität Giessen Fachbereich Medizin, Giessen, Hessen, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Department of Anaesthesiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gerss', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfälische Wilhelms-Universität Münster, Münster, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Wempe', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany zarbock@uni-muenster.de.'}]",BMJ open,['10.1136/bmjopen-2019-034201']
499,32251792,The Efficacy and Safety of High-dose Daptomycin in the Treatment of Complicated Skin and Soft Tissue Infections in Asians.,"OBJECTIVE
To compare the efficacy and safety of standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin in complicated skin and soft tissue infections (cSSTIs) in an Asian population.
MATERIALS AND METHODS
Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system. Patients included in the analysis were divided into two groups: those who received daptomycin at doses ≥ 6 mg/kg (HD group) and those receiving 4 mg/kg (SD group). The demographics and clinical treatment information were analyzed.
RESULTS
Overall, 155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group. The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005). Compared with the SD group, the HD group had statistically significant early clinical stabilization (72.34% vs 52.78%, P = 0.023). The results of the multivariate analysis indicated that HD daptomycin was an independent effector for early clinical stabilization (HR=0.394, P < 0.001). The rate of drug-related adverse events was equally distributed in the HD and SD groups (36.17% vs. 26.85%, P = 0.243).
CONCLUSION
Compared with SD daptomycin, HD daptomycin increased the rate of early clinical stabilization in Asian patients with cSSTIs, whereas the incidence of adverse events did not increase.",2020,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","['complicated skin and soft tissue infections (cSSTIs) in an Asian population', '155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group', 'Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system', 'Complicated Skin and Soft Tissue Infections in Asians']","['daptomycin at doses ≥ 6\u2009mg/kg (HD group) and those receiving 4\u2009mg/kg (SD group', 'High-dose Daptomycin', 'standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin']","['clinical stabilization', 'rate of early clinical stabilization', 'incidence of adverse events', 'rate of drug-related adverse events', 'rate of healthcare-associated infections', 'efficacy and safety']","[{'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",155.0,0.0449794,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","[{'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Dong', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Yong-Yuan', 'Initials': 'YY', 'LastName': 'Yao', 'Affiliation': ""Department of Intensive Care Medicine, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Guan', 'Affiliation': ""Department of Infectious Diseases, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Qing-Yan', 'Initials': 'QY', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Feng-Zhe', 'Initials': 'FZ', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China. Electronic address: clinicalpaper@163.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.03.060']
500,31669738,Enhanced recovery after surgery at cesarean delivery to reduce postoperative length of stay: a randomized controlled trial.,"OBJECTIVE
Our objective was to determine whether an enhanced recovery after surgery pathway at the time of cesarean birth would permit a reduction in postoperative length of stay and improve postoperative patient satisfaction compared to standard perioperative care.
MATERIALS AND METHODS
Patients undergoing nonemergent cesarean delivery at ≥37 weeks of gestation were randomized to enhanced recovery after surgery or standard care. Enhanced recovery after surgery involved multiple evidence-based interventions bundled into 1 protocol. The primary outcome was discharge on postoperative day 2. Secondary outcome variables included pain medication requirements, breastfeeding rates, and various measures of patient satisfaction.
RESULTS
From September 27, 2017, to May 2, 2018, a total of 58 women were randomized to enhanced recovery after surgery and 60 women to standard care. The groups were similar in medical comorbidities and in demographic and perioperative characteristics. Enhanced recovery after surgery was not associated with a significantly increased rate of postoperative day 2 discharges when compared with standard care (8.6% vs 3.3%, respectively; odds ratio, 2.74; 95% confidence interval, 0.51-14.70), but it was associated with a significantly reduced postoperative length of stay when compared with standard care, with a median length of stay of 73.5 hours (interquartile range, 71.08-76.62) vs 75.5 hours (interquartile range, 72.86-76.84) from surgery, difference in median length of stay (-1.92; 95% confidence interval, -3.80 to -0.29). Enhanced recovery after surgery was not associated with a reduction in postoperative narcotic use (117.16 ± 54.17 vs 119.38 ± 47.98 morphine milligram equivalents; mean difference, -2.22; 95% confidence interval, -20.86 to 16.42). More subjects randomized to the enhanced recovery after surgery protocol reported breastfeeding at discharge (67.2% vs 48.3%; P = .046). When patients were surveyed 6 weeks postpartum, those in the enhanced recovery after surgery group were more likely to feel that their expectations were met and that they had achieved their postoperative milestones earlier, and to report continued breastfeeding.
CONCLUSION
Enhanced recovery after surgery at cesarean delivery was not associated with an increase in the number of women discharged on postoperative day 2, but that may have been related to factors other than patients' medical readiness for discharge. Evidence that enhanced recovery after surgery at cesarean delivery may have the potential to improve outcomes such as day of discharge is suggested by the observed reduction in overall postoperative length of stay, improved patient satisfaction, and an increase in breastfeeding rates. Even better results may accrue with more provider and patient experience with enhanced recovery after surgery.",2020,"ERAS was not associated with a reduction in postoperative narcotic use, 117.16 ± 54.17 vs. 119.38 ± 47.98 morphine milligram equivalents (Mean difference: -2.22, 95% CI -20.86-16.42).","['Patients undergoing nonemergent cesarean delivery at ≥ 37 weeks of gestation', 'From September 27, 2017 to May 2, 2018, 58 women']","['ERAS or SC', 'ERAS']","['discharge on postoperative day 2 (POD#2', 'postoperative length of stay (LOS', 'Postoperative Length of Stay', 'pain medication requirements, breastfeeding rates and various measures of patient satisfaction', 'rate of POD#2 discharges', 'breastfeeding rates', 'median LOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",58.0,0.216052,"ERAS was not associated with a reduction in postoperative narcotic use, 117.16 ± 54.17 vs. 119.38 ± 47.98 morphine milligram equivalents (Mean difference: -2.22, 95% CI -20.86-16.42).","[{'ForeName': 'Nickolas C', 'Initials': 'NC', 'LastName': 'Teigen', 'Affiliation': 'Georgia Perinatal Consultants, Atlanta, GA. Electronic address: nickolas.teigen@gmail.com.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sahasrabudhe', 'Affiliation': 'Department of Obstetrics & Gynecology, Kaiser Permanente Southern California, Downey, CA.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Doulaveris', 'Affiliation': ""Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.""}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Abdissa', 'Initials': 'A', 'LastName': 'Negassa', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Anesthesia, New York University, New York, NY.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Bernstein', 'Affiliation': ""Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.10.009']
501,29059273,"A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy.","Background
This phase II study was conducted to assess clinical efficacy of tasquinimod maintenance therapy in patients with metastatic castrate-resistant prostate cancer not progressing during first-line docetaxel-based therapy.
Patients and methods
Patients were randomly assigned (1 : 1) to receive tasquinimod (0.25-1.0 mg/day orally) or placebo. The primary end point was radiologic progression-free survival (rPFS); secondary efficacy end points included: overall survival (OS); PFS on next-line therapy (PFS 2) and symptomatic PFS, assessed using the Brief Pain Inventory (BPI) questionnaire and analgesic use. Quality of life was measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and by the EuroQol-5 Dimension Quality of Life Instrument (EQ-5D). Adverse events were recorded.
Results
A total of 219 patients were screened and 144 patients randomized. The median duration of treatment was 18.7 weeks (range 0.6-102.7 weeks) for the tasquinimod arm and 19.2 weeks (range 0.4-80.0 weeks) for the placebo arm. Median (90% CI) rPFS was 31.7 (24.3-53.7) and 22.7 (16.1-25.9) weeks in the tasquinimod and placebo arms, respectively [HR (90% CI) 0.6 (0.4-0.9), P = 0.0162]. The median OS was not reached because only 14 deaths occurred by the cut-off date. No statistically significant differences between treatment arms were noted for symptomatic PFS, PFS 2, BPI score, FACT-P score, or EQ-5D. The incidence of any treatment emergent adverse event (TEAE) was similar in the tasquinimod and placebo arms (97.2% versus 94.3%, respectively), whereas severe TEAEs (NCI-CTC Grade 3-5) incidence was higher in the tasquinimod group (50.7% versus 27.1%).
Conclusions
Randomized trials testing new drugs as maintenance can be successfully conducted after chemotherapy in castrate-resistant prostate cancer. Maintenance tasquinimod therapy significantly reduced the risk of rPFS by 40%.
ClinicalTrials
gov identifier NCT01732549.",2017,"No statistically significant differences between treatment arms were noted for symptomatic PFS, PFS 2, BPI score, FACT-P score, or EQ-5D. The incidence of any treatment emergent adverse event (TEAE) was similar in the tasquinimod and placebo arms (97.2% versus 94.3%, respectively), whereas severe TEAEs (NCI-CTC Grade 3-5) incidence was higher in the tasquinimod group (50.7% versus 27.1%).
","['patients with metastatic castrate-resistant prostate cancer not progressing during first-line docetaxel-based therapy', 'Patients and methods\n\n\nPatients', 'castrate-resistant prostate cancer', '219 patients were screened and 144 patients randomized', 'patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy']","['tasquinimod', 'placebo', 'tasquinimod maintenance therapy']","['symptomatic PFS, PFS 2, BPI score, FACT-P score, or EQ-5D. The incidence of any treatment emergent adverse event (TEAE', 'severe TEAEs (NCI-CTC Grade 3-5) incidence', 'Adverse events', 'Quality of life', 'Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and by the EuroQol-5 Dimension Quality of Life Instrument (EQ-5D', 'risk of rPFS', 'clinical efficacy', 'median OS', 'median duration of treatment', 'radiologic progression-free survival (rPFS); secondary efficacy end points included: overall survival (OS); PFS on next-line therapy (PFS 2) and symptomatic PFS, assessed using the Brief Pain Inventory (BPI) questionnaire and analgesic use']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1956491', 'cui_str': 'tasquinimod'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment (qualifier value)'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",219.0,0.477906,"No statistically significant differences between treatment arms were noted for symptomatic PFS, PFS 2, BPI score, FACT-P score, or EQ-5D. The incidence of any treatment emergent adverse event (TEAE) was similar in the tasquinimod and placebo arms (97.2% versus 94.3%, respectively), whereas severe TEAEs (NCI-CTC Grade 3-5) incidence was higher in the tasquinimod group (50.7% versus 27.1%).
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, Université Paris-Saclay, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ulys', 'Affiliation': 'National Cancer Institute, Vilnius, Lithuania.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sengeløv', 'Affiliation': 'Department of Oncology, Herlev Hospital, Herlev.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moe', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ladoire', 'Affiliation': 'Department of Medical Oncology, Centre Georges François Leclerc, Dijon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': 'INSERM, UMR1098, Besançon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Flechon', 'Affiliation': 'Medicine, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guida', 'Affiliation': 'Department of Oncology & Hematology, Azienda University Hospital, Modena, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, USA.""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Climent', 'Affiliation': 'Department of Medical Oncology, Instituto Valenciano de Oncología, Valencia, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dumez', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven; KU Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Matouskova', 'Affiliation': 'Urocentrum, Prague, Czech Republic.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'General Oncology Department, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Liutkauskiene', 'Affiliation': 'Lithuanian University of Health Sciences Hospital, Kaunas, Lithuania.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stachurski', 'Affiliation': 'Gabinet Urologiczny, Gdynia, Gdańsk, Poland.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Baton', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Germann', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Daugaard', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx487']
502,32266500,Evaluation of low-volume post-dilution online hemodiafiltration with Japanese high-performance hemodiafilters.,"PURPOSE
To assess the removal performance of low-volume post-hemodiafiltration (HDF) with Japanese hemodiafilters and the removal performance with 20 % reduction in the total dialysate flow rate (Q d total).
METHODS
Subjects were 8 patients undergoing pre-HDF. Study 1: Post-HDF was performed at a blood flow rate (Q b ) of 250 mL/min and a total volume of substitution fluid (Vs) of 12 L/session(s) for 4 hrs using Fineflux-210Seco (FIX), ABH-21PA (ABH), and NVF-21H (NVF). We assessed removal efficiency of small molecular solutes, low-molecular-weight-proteins and the amount of albumin loss. Study 2: Post-HDF was performed at Vs of 12 L/s under G-1, Q d total of 500 and Q b of 250 mL/min; G-2, Q d total of 400 and Q b of 250 mL/min; and G-3, Q d total of 400 and Q b of 300 mL/min. Removal efficiency was compared and analyzed between these conditions.
RESULTS
Study 1: The results using FIX, ABH and NVF are shown in order. The Kt/V were 1.8, 1.9 and 1.8. The β 2 -Microglobulin (MG) removal rate (RR) (%) were 81.2, 83.1 and 82.8, and the α 1 -MG RR were 37.4, 40.2 and 38.5, respectively. Study 2: The results in G-1, 2 and 3 are shown in order. The Kt/V and the RR of small solutes, were significantly higher in G-3. The β 2 -MG RR (%) were 81.2, 80.1 and 81.0, and the α 1 -MG RR were 37.4, 37.5 and 38.0, respectively.
CONCLUSIONS
Low-volume post-HDF performed at Q b of 250 mL/min with Japanese high-performance hemodiafilters exhibited favorable removal efficiency for all solutes. Even with 20 % reduction in Q d total, the removal performance was also favorable.",2020,"The β 2 -Microglobulin (MG) removal rate (RR) (%) were 81.2, 83.1 and 82.8, and the α 1 -MG RR were 37.4, 40.2 and 38.5, respectively.",['with Japanese high-performance hemodiafilters'],"['low-volume post-hemodiafiltration (HDF', 'Japanese high-performance hemodiafilters', 'low-volume post-dilution online hemodiafiltration', 'Fineflux-210Seco (FIX), ABH-21PA (ABH), and NVF-21H (NVF']","['total dialysate flow rate (Q d total', 'removal performance', 'Removal efficiency', 'removal efficiency', 'Microglobulin\xa0(MG) removal rate (RR']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445431', 'cui_str': 'After the filter'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",8.0,0.0543162,"The β 2 -Microglobulin (MG) removal rate (RR) (%) were 81.2, 83.1 and 82.8, and the α 1 -MG RR were 37.4, 40.2 and 38.5, respectively.","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakurai', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan. ssakurai@peach.ocn.ne.jp.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Hosoya', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Fumi', 'Initials': 'F', 'LastName': 'Yamauchi', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Kurosawa', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan. saito@hashicli.jp.'}]",Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs,['10.1007/s10047-020-01167-y']
503,30958508,Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation: Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial.,"Importance
The NAVIGATE ESUS randomized clinical trial found that 15 mg of rivaroxaban per day does not reduce stroke compared with aspirin in patients with embolic stroke of undetermined source (ESUS); however, it substantially reduces stroke risk in patients with atrial fibrillation (AF).
Objective
To analyze whether rivaroxaban is associated with a reduction of recurrent stroke among patients with ESUS who have an increased risk of AF.
Design, Setting, and Participants
Participants were stratified by predictors of AF, including left atrial diameter, frequency of premature atrial contractions, and HAVOC score, a validated scheme using clinical features. Treatment interactions with these predictors were assessed. Participants were enrolled between December 2014 and September 2017, and analysis began March 2018.
Intervention
Rivaroxaban treatment vs aspirin.
Main Outcomes and Measures
Risk of ischemic stroke.
Results
Among 7112 patients with a mean (SD) age of 67 (9.8) years, the mean (SD) HAVOC score was 2.6 (1.8), the mean (SD) left atrial diameter was 3.8 (1.4) cm (n = 4022), and the median (interquartile range) daily frequency of premature atrial contractions was 48 (13-222). Detection of AF during follow-up increased for each tertile of HAVOC score: 2.3% (score, 0-2), 3.0% (score, 3), and 5.8% (score, >3); however, neither tertiles of the HAVOC score nor premature atrial contractions frequency impacted the association of rivaroxaban with recurrent ischemic stroke (P for interaction = .67 and .96, respectively). Atrial fibrillation annual incidence increased for each tertile of left atrial diameter (2.0%, 3.6%, and 5.2%) and for each tertile of premature atrial contractions frequency (1.3%, 2.9%, and 7.0%). Among the predefined subgroup of patients with a left atrial diameter of more than 4.6 cm (9% of overall population), the risk of ischemic stroke was lower among the rivaroxaban group (1.7% per year) compared with the aspirin group (6.5% per year) (hazard ratio, 0.26; 95% CI, 0.07-0.94; P for interaction = .02).
Conclusions and Relevance
The HAVOC score, left atrial diameter, and premature atrial contraction frequency predicted subsequent clinical AF. Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.",2019,"Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.","['patients with atrial fibrillation (AF', 'patients with ESUS and moderate or severe left atrial enlargement', '7112 patients with a mean (SD) age of 67 (9.8) years, the mean (SD) HAVOC score was 2.6\u2009(1.8), the mean (SD) left atrial diameter was 3.8\u2009(1.4) cm (n\u2009=\u20094022), and the median (interquartile range) daily frequency of premature atrial contractions was 48 (13-222', 'patients with ESUS who have an increased risk of AF.\nDesign, Setting, and Participants\n\n\nParticipants', 'patients with embolic stroke of undetermined source (ESUS', 'Participants were enrolled between December 2014 and September 2017, and analysis began March 2018']","['aspirin', 'Rivaroxaban', 'Aspirin', 'rivaroxaban', 'Rivaroxaban treatment vs aspirin']","['Detection of AF', 'recurrent stroke', 'Atrial fibrillation annual incidence', 'premature atrial contractions frequency', 'risk of ischemic stroke', 'Measures\n\n\nRisk of ischemic stroke', 'HAVOC score nor premature atrial contractions frequency', 'HAVOC score, left atrial diameter, and premature atrial contraction frequency', 'stroke risk', 'recurrent ischemic stroke', 'left atrial diameter']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0741276'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0033036', 'cui_str': 'Premature Atrial Contractions'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0033036', 'cui_str': 'Premature Atrial Contractions'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]",7112.0,0.0790898,"Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.","[{'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Division of Cardiology, Hamilton Health Sciences, Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gladstone', 'Affiliation': 'Division of Neurology and Hurvitz Brain Sciences Program, Sunnybrook Health Sciences Centre and Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Balakumar', 'Initials': 'B', 'LastName': 'Swaminathan', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eckstein', 'Affiliation': 'Department of Internal Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Epstein', 'Affiliation': 'Electrophysiology Section, Cardiovascular Division University of Pennsylvania, Cardiology Section, Philadelphia VA Medical Center, Philadelphia.'}, {'ForeName': 'Karl Georg', 'Initials': 'KG', 'LastName': 'Haeusler', 'Affiliation': 'Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulik', 'Affiliation': ""International Clinical Research Center and Neurology Department, St. Anne's University Hospital and Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Toni', 'Affiliation': 'Department of Human Neurosciences, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arauz', 'Affiliation': 'Instituto Nacional de Neurologia y Neurocirugia, Mexico D.F., Mexico City, Mexico.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'Department of Medicine, University of Thesally, Larissa, Greece.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'UWA Medical School, University of Western Australia, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Kanjana', 'Initials': 'K', 'LastName': 'Perera', 'Affiliation': 'McMaster University/Population Health Research Institute, Department of Medicine (Neurology), Hamilton, Ontario, Canada.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pagola', 'Affiliation': ""Unitat d'Ictus, Servei de Neurologia, Hospital Universitari Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Shuaib', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Lutsep', 'Affiliation': 'Department of Neurology, OHSU, VA Portland Health Care System, Portland, Oregon.'}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'International University of Health and Welfare, Sanno Hospital and Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Klinik für Neurologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Shelagh B', 'Initials': 'SB', 'LastName': 'Coutts', 'Affiliation': 'Department of Clinical Neurosciences, Radiology, and Community Health Sciences, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Karlinski', 'Affiliation': 'Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Czlonkowska', 'Affiliation': '2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': 'Department of Pharmacology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Santo', 'Affiliation': 'Neurology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer US LLC, Pharmaceuticals Clinical Development Thrombosis, Whippany, New Jersey.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Division of Cardiology, Hamilton Health Sciences, Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA neurology,['10.1001/jamaneurol.2019.0617']
504,30958514,Effects of Mindfulness Yoga vs Stretching and Resistance Training Exercises on Anxiety and Depression for People With Parkinson Disease: A Randomized Clinical Trial.,"Importance
Clinical practice guidelines support exercise for patients with Parkinson disease (PD), but to our knowledge, no randomized clinical trials have tested whether yoga is superior to conventional physical exercises for stress and symptom management.
Objective
To compare the effects of a mindfulness yoga program vs stretching and resistance training exercise (SRTE) on psychological distress, physical health, spiritual well-being, and health-related quality of life (HRQOL) in patients with mild-to-moderate PD.
Design, Setting, and Participants
An assessor-masked, randomized clinical trial using the intention-to-treat principle was conducted at 4 community rehabilitation centers in Hong Kong between December 1, 2016, and May 31, 2017. A total of 187 adults (aged ≥18 years) with a clinical diagnosis of idiopathic PD who were able to stand unaided and walk with or without an assistive device were enrolled via convenience sampling. Eligible participants were randomized 1:1 to mindfulness yoga or SRTE.
Interventions
Mindfulness yoga was delivered in 90-minute groups and SRTE were delivered in 60-minute groups for 8 weeks.
Main Outcomes and Measures
Primary outcomes included anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale. Secondary outcomes included severity of motor symptoms (Movement Disorder Society Unified Parkinson's Disease Rating Scale [MDS-UPDRS], Part III motor score), mobility, spiritual well-being in terms of perceived hardship and equanimity, and HRQOL. Assessments were done at baseline, 8 weeks (T1), and 20 weeks (T2).
Results
The 138 participants included 65 men (47.1%) with a mean (SD) age of 63.7 (8.7) years and a mean (SD) MDS-UPDRS score of 33.3 (15.3). Generalized estimating equation analyses revealed that the yoga group had significantly better improvement in outcomes than the SRTE group, particularly for anxiety (time-by-group interaction, T1: β, -1.79 [95% CI, -2.85 to -0.69; P = .001]; T2: β, -2.05 [95% CI, -3.02 to -1.08; P < .001]), depression (T1: β, -2.75 [95% CI, -3.17 to -1.35; P < .001]); T2: β, -2.75 [95% CI, -3.71 to -1.79; P < .001]), perceived hardship (T1: β, -0.92 [95% CI, -1.25 to -0.61; P < .001]; T2: β, -0.76 [95% CI, -1.12 to -0.40; P < .001]), perceived equanimity (T1: β, 1.11 [95% CI, 0.79-1.42; P < .001]; T2: β, 1.19 [95% CI, 0.82-1.56; P < .001]), and disease-specific HRQOL (T1: β, -7.77 [95% CI, -11.61 to -4.38; P < .001]; T2: β, -7.99 [95% CI, -11.61 to -4.38; P < .001]).
Conclusions and Relevance
Among patients with mild-to-moderate PD, the mindfulness yoga program was found to be as effective as SRTE in improving motor dysfunction and mobility, with the additional benefits of a reduction in anxiety and depressive symptoms and an increase in spiritual well-being and HRQOL.
Trial Registration
Centre for Clinical Research and Biostatistics identifier: CUHK_CCRB00522.",2019,"Generalized estimating equation analyses revealed that the yoga group had significantly better improvement in outcomes than the SRTE group, particularly for anxiety (time-by-group interaction, T1: β,","['patients with Parkinson disease (PD', '187 adults (aged ≥18 years) with a clinical diagnosis of idiopathic PD who were able to stand unaided and walk with or without an assistive device were enrolled via convenience sampling', '138 participants included 65 men (47.1%) with a mean (SD) age of 63.7 (8.7) years and a mean (SD) MDS-UPDRS score of 33.3 (15.3', 'People With Parkinson Disease', '4 community rehabilitation centers in Hong Kong between December 1, 2016, and May 31, 2017', 'Eligible participants', 'patients with mild-to-moderate PD']","['mindfulness yoga program vs stretching and resistance training exercise (SRTE', 'Mindfulness Yoga vs Stretching and Resistance Training Exercises', 'mindfulness yoga or SRTE']","['disease-specific HRQOL ', 'psychological distress, physical health, spiritual well-being, and health-related quality of life (HRQOL', ""severity of motor symptoms (Movement Disorder Society Unified Parkinson's Disease Rating Scale [MDS-UPDRS], Part III motor score), mobility, spiritual well-being in terms of perceived hardship and equanimity, and HRQOL"", 'anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale', 'Anxiety and Depression', 'anxiety and depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0560884', 'cui_str': 'Able to stand (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0036605', 'cui_str': 'Assistive Technology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517716', 'cui_str': 'Thirty-three point three'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",187.0,0.193096,"Generalized estimating equation analyses revealed that the yoga group had significantly better improvement in outcomes than the SRTE group, particularly for anxiety (time-by-group interaction, T1: β,","[{'ForeName': 'Jojo Y Y', 'Initials': 'JYY', 'LastName': 'Kwok', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Jackie C Y', 'Initials': 'JCY', 'LastName': 'Kwan', 'Affiliation': 'The Hong Kong Society for Rehabilitation, Hong Kong Special Administrative Region.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Auyeung', 'Affiliation': 'Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong Special Administrative Region.'}, {'ForeName': 'Vincent C T', 'Initials': 'VCT', 'LastName': 'Mok', 'Affiliation': 'Department of Medicine and Therapeutics, Therese Pei Fong Chow Research Center for Prevention of Dementia, Gerald Choa Neuroscience Centre, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Claire K Y', 'Initials': 'CKY', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong Special Administration Region.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Helen Y L', 'Initials': 'HYL', 'LastName': 'Chan', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.'}]",JAMA neurology,['10.1001/jamaneurol.2019.0534']
505,32142961,Effectiveness of myAirCoach: A mHealth Self-Management System in Asthma.,"BACKGROUND
Self-management programs have beneficial effects on asthma control, but their implementation in clinical practice is poor. Mobile health (mHealth) could play an important role in enhancing self-management.
OBJECTIVE
To assess the clinical effectiveness and technology acceptance of myAirCoach-supported self-management on top of usual care in patients with asthma using inhalation medication.
METHODS
Patients were recruited in 2 separate studies. The myAirCoach system consisted of an inhaler adapter, an indoor air-quality monitor, a physical activity tracker, a portable spirometer, a fraction exhaled nitric oxide device, and an app. The primary outcome was asthma control; secondary outcomes were exacerbations, quality of life, and technology acceptance. In study 1, 30 participants were randomized to either usual care or myAirCoach support for 3 to 6 months; in study 2, 12 participants were provided with the myAirCoach system in a 3-month before-after study.
RESULTS
In study 1, asthma control improved in the intervention group compared with controls (Asthma Control Questionnaire difference, 0.70; P = .006). A total of 6 exacerbations occurred in the intervention group compared with 12 in the control group (hazard ratio, 0.31; P = .06). Asthma-related quality of life improved (mini Asthma-related Quality of Life Questionnaire difference, 0.53; P = .04), but forced expiratory volume in 1 second was unchanged. In study 2, asthma control improved by 0.86 compared with baseline (P = .007) and quality of life by 0.16 (P = .64). Participants reported positive attitudes toward the system.
DISCUSSION
Using the myAirCoach support system improves asthma control and quality of life, with a reduction in severe asthma exacerbations. Well-validated mHealth technologies should therefore be further studied.",2020,"Asthma related quality of life improved (m-AQLQ difference 0.53, p= 0.04), but FEV1 was unchanged.","['asthma', 'asthma patients using inhalation medication ', '30 participants', 'Patients were recruited in two separate studies']","['myAirCoach supported self-management', 'usual care or myAirCoach support', 'myAirCoach support system', 'myAirCoach']","['Asthma related quality of life', 'six exacerbations', 'quality of life', 'asthma control', 'severe asthma exacerbations', 'FEV1', 'exacerbations, quality of life, and technology acceptance', 'asthma control and quality of life']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",30.0,0.0768581,"Asthma related quality of life improved (m-AQLQ difference 0.53, p= 0.04), but FEV1 was unchanged.","[{'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Khusial', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: R.J.Khusial@lumc.nl.'}, {'ForeName': 'Persijn J', 'Initials': 'PJ', 'LastName': 'Honkoop', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Usmani', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Soares', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, NIHR Manchester Biomedical Research Centre (BRC), University of Manchester, Manchester, United Kingdom; Manchester University NHS Foundation Trust - Wythenshawe Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, NIHR Manchester Biomedical Research Centre (BRC), University of Manchester, Manchester, United Kingdom; Manchester University NHS Foundation Trust - Wythenshawe Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Biddiscombe', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Meah', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bonini', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Lalas', 'Affiliation': 'Information Technologies Institute, Centre for Research and Technology - Hellas (CERTH), Thessaloniki, Greece.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Polychronidou', 'Affiliation': 'Information Technologies Institute, Centre for Research and Technology - Hellas (CERTH), Thessaloniki, Greece.'}, {'ForeName': 'Julia G', 'Initials': 'JG', 'LastName': 'Koopmans', 'Affiliation': 'Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Moustakas', 'Affiliation': 'Electrical and Computer Engineering Department, University of Patras, Rion-Patras, Greece.'}, {'ForeName': 'Jiska B', 'Initials': 'JB', 'LastName': 'Snoeck-Stroband', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Ortmann', 'Affiliation': 'IHP - Leibniz-Institut für innovative Mikroelektronik, Frankfurt (Oder), Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Votis', 'Affiliation': 'Information Technologies Institute, Centre for Research and Technology - Hellas (CERTH), Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tzovaras', 'Affiliation': 'Information Technologies Institute, Centre for Research and Technology - Hellas (CERTH), Thessaloniki, Greece.'}, {'ForeName': 'Kian Fan', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton and Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fowler', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, NIHR Manchester Biomedical Research Centre (BRC), University of Manchester, Manchester, United Kingdom; Manchester University NHS Foundation Trust - Wythenshawe Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Jacob K', 'Initials': 'JK', 'LastName': 'Sont', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.02.018']
506,31185369,Loving-kindness meditation slows biological aging in novices: Evidence from a 12-week randomized controlled trial.,"Combinations of multiple meditation practices have been shown to reduce the attrition of telomeres, the protective caps of chromosomes (Carlson et al., 2015). Here, we probed the distinct effects on telomere length (TL) of mindfulness meditation (MM) and loving-kindness meditation (LKM). Midlife adults (N = 142) were randomized to be in a waitlist control condition or to learn either MM or LKM in a 6-week workshop. Telomere length was assessed 2 weeks before the start of the workshops and 3 weeks after their termination. After controlling for appropriate demographic covariates and baseline TL, we found TL decreased significantly in the MM group and the control group, but not in the LKM group. There was also significantly less TL attrition in the LKM group than the control group. The MM group showed changes in TL that were intermediate between the LKM and control groups yet not significantly different from either. Self-reported emotions and practice intensity (duration and frequency) did not mediate these observed group differences. This study is the first to disentangle the effects of LKM and MM on TL and suggests that LKM may buffer telomere attrition.",2019,The MM group showed changes in TL that were intermediate between the LKM and control groups yet not significantly different from either.,"['Midlife adults (N\u2009=\u2009142', 'novices']","['waitlist control condition or to learn either MM or LKM', 'LKM', 'Loving-kindness meditation']","['TL attrition', 'telomere length (TL) of mindfulness meditation (MM) and loving-kindness meditation (LKM', 'Telomere length', 'Self-reported emotions and practice intensity (duration and frequency', 'TL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0150277'}]","[{'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0441567,The MM group showed changes in TL that were intermediate between the LKM and control groups yet not significantly different from either.,"[{'ForeName': 'Khoa D', 'Initials': 'KD', 'LastName': 'Le Nguyen', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, CB #3270, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Biochemistry & Biophysics, University of California, 600 16th St, San Francisco, CA, 94158, USA.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Algoe', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, CB #3270, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Brantley', 'Affiliation': 'Duke Integrative Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sumi L', 'Initials': 'SL', 'LastName': 'Kim', 'Affiliation': 'Office of Religious Life, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Brantley', 'Affiliation': 'Duke Integrative Medicine, Duke University, Durham, NC, USA; Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Salzberg', 'Affiliation': 'Insight Meditation Society, Barre, MA, USA.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Fredrickson', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, CB #3270, Chapel Hill, NC, 27599, USA. Electronic address: blf@unc.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.05.020']
507,32251139,Education Increases Disposal of Unused Opioids After Total Joint Arthroplasty: A Cluster-Randomized Controlled Trial.,"BACKGROUND
Unused opioid pills are a danger to patients and their loved ones as they may be diverted for abuse or misuse. The purpose of this study was to determine the baseline rate of proper disposal of unused opioids among patients undergoing total joint arthroplasty and to determine how education impacts disposal rates.
METHODS
In this study, 563 patients undergoing primary total joint arthroplasty (183 patients undergoing total hip arthroplasty, 293 patients undergoing total knee arthroplasty, and 87 patients undergoing unicompartmental knee arthroplasty) were cluster-randomized to groups that received no education, educational pamphlets, or educational pamphlets plus text messages. Patients were randomized by education class and were blinded to participation to avoid behavioral modifications. Patients were surveyed at 6 weeks postoperatively to determine if they disposed of their unused opioid pills using a U.S. Food and Drug Administration-recommended method, which was the primary outcome. Assuming a 15% difference in opioid disposal rates as clinically relevant, power analysis determined that 76 patients with unused opioids were required per group (228 total). An as-treated analysis was conducted with the Fisher exact text and analysis of variance with alpha = 0.05.
RESULTS
A total of 539 patients (95.7%) completed the survey, and 342 patients (63.5%) had unused opioid pills at 6 weeks postoperatively: 89 patients in the no education group, 128 patients in the pamphlet group, and 125 patients in the pamphlet and text message group. Of these 342 patients, 9.0% of patients in the no education group, 32.8% of patients in the pamphlet group, and 38.4% of patients in the pamphlet and text message group properly disposed of their unused opioids (p = 0.001 for each educational intervention compared with no education). Unused opioid pills were kept by 82.0% of patients in the no education group, 64.1% of patients in the pamphlet group, and 54.4% of patients in the pamphlet and text message group (p < 0.001 for the no education group compared with either educational strategy group). Patients who underwent total hip arthroplasty were more likely to properly dispose of their unused opioids compared with those who underwent total knee arthroplasty (odds ratio, 2.1; p = 0.005). There were no demographic differences between groups, including inpatient opioid use, refills, and preoperative opioid use, other than sex (41.5% male patients in the no education group, 55.0% male patients in the pamphlet group, and 37.4% male patients in the pamphlet and text message group; p = 0.001), suggesting appropriate randomization.
CONCLUSIONS
The rate of opioid disposal is very low after total joint arthroplasty. Education on opioid disposal more than triples opioid disposal rates compared with no education. To help to prevent diversion of unused opioid pills, all patients who undergo total joint arthroplasty should be educated on the proper disposal of unused opioids.",2020,"Unused opioid pills were kept by 82.0% of patients in the no education group, 64.1% of patients in the pamphlet group, and 54.4% of patients in the pamphlet and text message group (p < 0.001 for the no education group compared with either educational strategy group).","['539 patients (95.7%) completed the survey, and 342 patients (63.5%) had unused opioid pills at 6 weeks postoperatively: 89 patients in the no education group, 128 patients in the pamphlet group, and 125 patients in the pamphlet and text message group', 'patients undergoing total joint arthroplasty', '563 patients undergoing primary total joint arthroplasty (183 patients undergoing total hip arthroplasty, 293 patients undergoing total knee arthroplasty, and 87 patients undergoing unicompartmental knee arthroplasty']","['no education, educational pamphlets, or educational pamphlets plus text messages']","['rate of opioid disposal', 'inpatient opioid use, refills, and preoperative opioid use', 'opioid disposal rates', 'Education Increases Disposal of Unused Opioids']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0445107', 'cui_str': 'Not used'}]",563.0,0.0723599,"Unused opioid pills were kept by 82.0% of patients in the no education group, 64.1% of patients in the pamphlet group, and 54.4% of patients in the pamphlet and text message group (p < 0.001 for the no education group compared with either educational strategy group).","[{'ForeName': 'Cindy R', 'Initials': 'CR', 'LastName': 'Nahhas', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Hannon', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'JaeWon', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Tad L', 'Initials': 'TL', 'LastName': 'Gerlinger', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01166']
508,32173628,Long-term effect of patient decision aids on use of joint replacement and health care costs.,"OBJECTIVE
Shared decision-making supported by patient decisions aids may improve care and reduce healthcare costs for persons considering total joint replacement. Observational studies and randomized controlled trials (RCTs) have evaluated the short-term impact of decision aids on uptake of surgery and costs, however the long-term effects are unclear. This analysis aimed to evaluate the effect of patient decision aids on 1) use of joint replacement up to 7-years of follow-up, and 2) osteoarthritis-related health system costs.
METHODS
324 participants in a Canadian RCT with 2-years follow-up who were randomized to either a decision aid (n = 161) or usual care (n = 163) had their trial and health administrative data linked. The proportion undergoing surgery up to 7-years were compared using cumulative incidence plots and competing risk regression. Mean per-patient costs were compared using two sample t-tests.
RESULTS
At 2-years, 119 of 161 (73.9%) patients in the decision aid arm and 129 of 163 (79.1%) patients in the usual care arm had surgery. Between two and 7-years, 17 additional patients in both the decision aid (of 42, 40.4%) and usual care (of 34, 50.0%) arms underwent surgery. At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care.
CONCLUSIONS
This is the first study to assess the long-term impact of decision aids on use of joint replacement and healthcare costs. These results are not conclusive but can inform future trial design.
CLINICAL TRIAL REGISTRATION
The full trial protocol is available at ClinicalTrials.Gov (NCT00911638).",2020,"At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care.
","['324 participants in a Canadian RCT with 2-years follow-up who were randomized to either a decision aid (n\xa0=\xa0161) or usual care (n\xa0=\xa0163) had their trial and health administrative data linked', 'persons considering total joint replacement']","['patient decision aids', 'decision aids']","['usual care', 'mean per-patient costs', 'Mean per-patient costs', 'likelihood of undergoing surgery']","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",,0.137968,"At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trenaman', 'Affiliation': 'University of British Columbia, Vancouver, Canada; Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bryan', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Payne', 'Affiliation': 'The University of Manchester, Manchester, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hawker', 'Affiliation': 'The University of Toronto, Toronto, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bansback', 'Affiliation': 'University of British Columbia, Vancouver, Canada; Centre for Health Evaluation and Outcome Sciences, Vancouver, Canada. Electronic address: nick.bansback@ubc.ca.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.01.019']
509,28950289,"An exploratory, open-label, randomized, multicenter study to investigate the pharmacodynamics of a glycoengineered antibody (imgatuzumab) and cetuximab in patients with operable head and neck squamous cell carcinoma.","Background
In addition to inhibiting epidermal growth factor receptor (EGFR) signaling, anti-EGFR antibodies of the IgG1 'subtype' can induce a complementary therapeutic effect through the induction of antibody-dependent cell-mediated cytotoxicity (ADCC). Glycoengineering of therapeutic antibodies increases the affinity for the Fc-gamma receptor, thereby enhancing ADCC.
Patients and methods
We investigated the changes in immune effector cells and EGFR pathway biomarkers in 44 patients with operable, advanced stage head and neck squamous cell carcinoma treated with two preoperative doses of either glycoengineered imgatuzumab (GA201; 700 or 1400 mg) or cetuximab (standard dosing) in a neoadjuvant setting with paired pre- and post-treatment tumor biopsies.
Results
Significant antitumor activity was observed with both antibodies after just two infusions. Metabolic responses were seen in 23 (59.0%) patients overall. One imgatuzumab-treated patient (700 mg) achieved a 'pathological' complete response. An immediate and sustained decrease in peripheral natural killer cells was consistently observed with the first imgatuzumab infusion but not with cetuximab. The functionality of the remaining peripheral natural killer cells was maintained. Similarly, a pronounced increase in circulating cytokines was seen following the first infusion of imgatuzumab but not cetuximab. Overall, tumor-infiltrating CD3+ cell counts increased following treatment with both antibodies. A significant increase from baseline in CD3+/perforin+ cytotoxic T cells occurred only in the 700-mg imgatuzumab group (median 95% increase, P < 0.05). The most prominent decrease of EGFR-expressing cells was recorded after treatment with imgatuzumab (700 mg, -34.6%; 1400 mg, -41.8%). The post-treatment inflammatory tumor microenvironment was strongly related to baseline tumor-infiltrating immune cell density, and baseline levels of EGFR and pERK in tumor cells most strongly predicted therapeutic response.
Conclusions
These pharmacodynamic observations and relationship with efficacy are consistent with the proposed mode of action of imgatuzumab combining efficient EGFR pathway inhibition with ADCC-related immune antitumor effects.
Clinical trial registration number
NCT01046266 (ClinicalTrials.gov).",2017,"A significant increase from baseline in CD3+/perforin+ cytotoxic T cells occurred only in the 700-mg imgatuzumab group (median 95% increase, P < 0.05).","['44 patients with operable, advanced stage head and neck squamous cell carcinoma treated with two preoperative doses of either', 'patients with operable head and neck squamous cell carcinoma']","['glycoengineered antibody (imgatuzumab) and cetuximab', 'glycoengineered imgatuzumab (GA201; 700 or 1400\u2009mg) or cetuximab (standard dosing) in a neoadjuvant setting with paired pre- and post-treatment tumor biopsies', 'imgatuzumab']","['Metabolic responses', 'EGFR-expressing cells', 'Overall, tumor-infiltrating CD3+\u2009cell counts', 'antitumor activity', 'peripheral natural killer cells', 'circulating cytokines', 'CD3+/perforin+\u2009cytotoxic T cells']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0882828', 'cui_str': 'Cell positive for CD3 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",44.0,0.0308754,"A significant increase from baseline in CD3+/perforin+ cytotoxic T cells occurred only in the 700-mg imgatuzumab group (median 95% increase, P < 0.05).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Temam', 'Affiliation': 'Department of Head and Neck Surgical Oncology, Institut Gustave Roussy, Villejuif, France. Electronic address: stephane.temam@gustaveroussy.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spicer', 'Affiliation': 'Division of Cancer Studies.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Farzaneh', 'Affiliation': ""Department of Haematological Medicine, King's College London, London, UK.""}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Soria', 'Affiliation': 'DITEP (Drug Development Department), Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Oppenheim', 'Affiliation': ""Department of Haematological Medicine, King's College London, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'McGurk', 'Affiliation': ""Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hollebecque', 'Affiliation': 'DITEP (Drug Development Department), Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sarini', 'Affiliation': 'Department of Surgery, Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hussain', 'Affiliation': ""Head and Neck Surgery, King's College London, Guy's Hospital Campus, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Soehrman Brossard', 'Affiliation': 'Roche Innovation Center Basel, Basel.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Manenti', 'Affiliation': 'Roche Innovation Center Zurich, Schlieren, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Evers', 'Affiliation': 'Roche Innovation Center Zurich, Schlieren, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Delmar', 'Affiliation': 'Roche Innovation Center Basel, Basel.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Di Scala', 'Affiliation': 'Roche Innovation Center Basel, Basel.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mancao', 'Affiliation': 'Roche Innovation Center Basel, Basel.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Feuerhake', 'Affiliation': 'Institute for Pathology, Hannover Medical School, Hannover; Institute for Neuropathology, University Hospital Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Andries', 'Affiliation': 'HistoGeneX, Antwerpen, Belgium.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Ott', 'Affiliation': 'Roche Innovation Center Basel, Basel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Passioukov', 'Affiliation': 'Roche Innovation Center Zurich, Schlieren, Switzerland.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Clinical Research Unit, Institut Claudius Regaud, Toulouse, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx489']
510,32248256,Does 3D stereoscopy support anatomical education?,"PURPOSE
The teaching of anatomy in medical education has historically been based on lectures, cadaveric dissections, and illustrated books for students. Stereoscopic 3D videos are now easily accessible via smartphone and affordable for students. This study aimed to investigate whether a 3D stereoscopic instruction video could improve learning over 2D video.
METHODS
A prospective controlled study on a single-site was conducted at the University of Angers. Content knowledge was assessed, followed by the presentation of an instructional neuroanatomy video. Participants watched the video in either 3D or 2D format, then they completed an anatomy written test. Pre-video and post-video performances were analyzed with independent t tests on total score, fundamental anatomical knowledge, anatomical relationships and reasoning.
RESULTS
175 subjects completed the study. At baseline, the 3D (n = 91) and 2D (n = 86) groups were similar, in age and class level. 3D and 2D scores were similar in the pre-test session and in the fundamental knowledge post-test (mean 73.2% vs 74.4%, p = 0.37). Average scores for the 3D group were better for the post-test regarding anatomical relationships (mean 86.4% vs. 63.5%, p = 0.004), clinical inference/reasoning (mean 76.8% vs. 67.6%, p = 0.023) and total note (mean 76.8% vs. 67.6%, p = 0.07). Regarding the 3D student's satisfaction questionnaire (n = 91), 70 students (77%) agreed that the stereoscopic video allowed good 3D visualization of anatomical structures. The student enjoyed using the stereoscopic video (n = 75, 82.5%). Most students supported the use of this kind of stereoscopic 3D video in their normal teaching as a complementary tool (n = 78, 85%).
CONCLUSIONS
The incorporation of 3D videos as ancillary teaching into curricula could be of interest to improve the knowledge of anatomical relationships and reasoning among students.",2020,"Average scores for the 3D group were better for the post-test regarding anatomical relationships (mean 86.4% vs. 63.5%, p = 0.004), clinical inference/reasoning (mean 76.8% vs. 67.6%, p = 0.023) and total note (mean 76.8% vs. 67.6%, p = 0.07).",['175 subjects completed the study'],['3D stereoscopic instruction video'],"['3D and 2D scores', 'total note', 'total score, fundamental anatomical knowledge, anatomical relationships and reasoning', 'Content knowledge', 'Average scores', 'clinical inference/reasoning']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",175.0,0.0297147,"Average scores for the 3D group were better for the post-test regarding anatomical relationships (mean 86.4% vs. 63.5%, p = 0.004), clinical inference/reasoning (mean 76.8% vs. 67.6%, p = 0.023) and total note (mean 76.8% vs. 67.6%, p = 0.07).","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Bernard', 'Affiliation': 'Laboratory of Anatomy, Faculté de Médecine, 49100, Angers, France. bernardflorian.bf@gmail.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richard', 'Affiliation': '3D-Lab University of Angers, Angers, France.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Kahn', 'Affiliation': 'Laboratory of Anatomy, Faculté de Médecine, 49100, Angers, France.'}, {'ForeName': 'Henri-Dominique', 'Initials': 'HD', 'LastName': 'Fournier', 'Affiliation': 'Laboratory of Anatomy, Faculté de Médecine, 49100, Angers, France.'}]",Surgical and radiologic anatomy : SRA,['10.1007/s00276-020-02465-z']
511,32005747,Predictive Biomarkers for Adjuvant Capecitabine Benefit in Early-Stage Triple-Negative Breast Cancer in the FinXX Clinical Trial.,"PURPOSE
Recent studies have demonstrated a benefit of adjuvant capecitabine in early breast cancer, particularly in patients with triple-negative breast cancer (TNBC). However, TNBC is heterogeneous and more precise predictive biomarkers are needed.
EXPERIMENTAL DESIGN
Tumor tissues collected from TNBC patients in the FinXX trial, randomized to adjuvant anthracycline-taxane-based chemotherapy with or without capecitabine, were analyzed using a 770-gene panel targeting multiple biological mechanisms and additional 30-custom genes related to capecitabine metabolism. Hypothesis-generating exploratory analyses were performed to assess biomarker expression in relation to treatment effect using the Cox regression model and interaction tests adjusted for multiplicity.
RESULTS
One hundred eleven TNBC samples were evaluable (57 without capecitabine and 54 with capecitabine). The median follow-up was 10.2 years. Multivariate analysis showed significant improvement in recurrence-free survival (RFS) favoring capecitabine in four biologically important genes and metagenes, including cytotoxic cells [hazard ratio (HR) = 0.38; 95% confidence intervals (CI), 0.16-0.86, P -interaction = 0.01], endothelial (HR = 0.67; 95% CI, 0.20-2.22, P -interaction = 0.02), mast cells (HR = 0.78; 95% CI, 0.49-1.27, P -interaction = 0.04), and PDL2 (HR = 0.31; 95% CI, 0.12-0.81, P -interaction = 0.03). Furthermore, we identified 38 single genes that were significantly associated with capecitabine benefit, and these were dominated by immune response pathway and enzymes involved in activating capecitabine to fluorouracil, including TYMP . However, these results were not significant when adjusted for multiple testing.
CONCLUSIONS
Genes and metagenes related to antitumor immunity, immune response, and capecitabine activation could identify TNBC patients who are more likely to benefit from adjuvant capecitabine. Given the reduced power to observe significant findings when correcting for multiplicity, our findings provide the basis for future hypothesis-testing validation studies on larger clinical trials.",2020,"Multivariate analysis showed significant improvement in RFS favoring capecitabine in four biologically-important genes and metagenes, including cytotoxic cells (HR=0.38, 95%CI 0.16-0.86, P -interaction=0.01), endothelial (HR=0.67, 95%CI 0.20-2.22, P -interaction=0.02), mast cells (HR=0.78, 95%CI 0.49-1.27, P -interaction=0.04), and PDL2 (HR=0.31, 95%CI 0.12-0.81, P -interaction=0.03).","['patients with triple negative breast cancer (TNBC', 'early stage triple negative breast cancer in the FinXX clinical trial', 'Tumor tissues collected from TNBC patients in the FinXX trial, randomized to']","['capecitabine', 'adjuvant anthracycline-taxane based chemotherapy with or without capecitabine', 'TNBC']","['cytotoxic cells', 'mast cells', 'RFS favoring capecitabine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0024880', 'cui_str': 'Basophils, Tissue'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]",,0.0580373,"Multivariate analysis showed significant improvement in RFS favoring capecitabine in four biologically-important genes and metagenes, including cytotoxic cells (HR=0.38, 95%CI 0.16-0.86, P -interaction=0.01), endothelial (HR=0.67, 95%CI 0.20-2.22, P -interaction=0.02), mast cells (HR=0.78, 95%CI 0.49-1.27, P -interaction=0.04), and PDL2 (HR=0.31, 95%CI 0.12-0.81, P -interaction=0.03).","[{'ForeName': 'Karama', 'Initials': 'K', 'LastName': 'Asleh', 'Affiliation': 'Genetic Pathology Evaluation Centre, Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Heather Ann', 'Initials': 'HA', 'LastName': 'Brauer', 'Affiliation': 'NanoString Technologies Inc., Seattle, Washington.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Sullivan', 'Affiliation': 'NanoString Technologies Inc., Seattle, Washington.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Lauttia', 'Affiliation': 'Laboratory of Molecular Oncology, Biomedicum Helsinki, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Lindman', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Torsten O', 'Initials': 'TO', 'LastName': 'Nielsen', 'Affiliation': 'Genetic Pathology Evaluation Centre, Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Joensuu', 'Affiliation': 'Laboratory of Molecular Oncology, Biomedicum Helsinki, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'E Aubrey', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Department of Cancer Biology, Mayo Clinic Comprehensive Cancer Center, Jacksonville, Florida.'}, {'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Robert and Monica Jacoby Center for Breast Health, Mayo Clinic, Jacksonville, Florida. chumsri.saranya@mayo.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1945']
512,32144974,Long-term effects of intra-articular oxygen-ozone therapy versus hyaluronic acid in older people affected by knee osteoarthritis: A randomized single-blind extension study.,"BACKGROUND
There is little evidence on intra-articular (IA) treatment in knee osteoarthritis (KOA) and there is a lack of long-term follow-up studies.
OBJECTIVE
To assess the long-term effectiveness and safety of IA oxygen-ozone (O2O3) and hyaluronic acid (HA) in terms of functioning in KOA patients over a 31-week period.
METHODS
Patients aged ⩾ 60 years with KOA were randomly allocated to receive 4 IA knee injections (1/week) of O2O3 or HA (T0-T3) and a follow-up visit 4 weeks after the fourth injection (T4). In this extension study we assessed VAS and safety in patients with Visual Analogue Scale (VAS) ⩾ 4 at the at 6-month follow-up visit (T5), undergoing a second treatment cycle (T5-T8) and 1-month follow-up visit (T9).
RESULTS
Forty-two patients (aged 70.5 ± 5.8 years) were randomly allocated to O2O3 (n= 22) or HA group (n= 20). Twenty-three underwent another IA cycle: 12 (54.6%) in the O2O3 group and 11 (55.0%) in the HA group. Both groups showed significant reduction in VAS (p< 0.013) compared to baseline during both cycles. At follow-up visits (T4 and T9), VAS was significantly lower in the HA group (p< 0.013). There were no differences in adverse events occurrence between groups.
CONCLUSIONS
IA O2O3 might be comparable to HA in terms of effectiveness and safety in reducing pain in KOA patients, although at both follow-up visits (T4 and T9) VAS was significantly lower in the HA group.",2020,"At follow-up visits (T4 and T9), VAS was significantly lower in the HA group (p< 0.013).","['Patients aged ⩾ 60 years with KOA', 'older people affected by knee osteoarthritis', 'Forty-two patients (aged 70.5 ± 5.8 years', 'KOA patients over a 31-week period', 'patients with Visual Analogue Scale (VAS) ⩾ 4 at the at 6-month follow-up visit (T5), undergoing a second treatment cycle (T5-T8) and 1-month follow-up visit (T9']","['intra-articular oxygen-ozone therapy versus hyaluronic acid', '4 IA knee injections (1/week) of O2O3 or HA (T0-T3', 'IA oxygen-ozone (O2O3) and hyaluronic acid (HA']","['VAS', 'VAS and safety', 'adverse events occurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0537561', 'cui_str': '4-iodoacridine, I125-labeled'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.0870579,"At follow-up visits (T4 and T9), VAS was significantly lower in the HA group (p< 0.013).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'de Sire', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Stagno', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}, {'ForeName': 'Marco Alessandro', 'Initials': 'MA', 'LastName': 'Minetto', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cisari', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Baricich', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Invernizzi', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181294']
513,29799105,The Effect of Spiritual Self-care Training on the Quality of Life of Mothers of Preterm Infants: A Randomized Controlled Trial.,"The present study was carried out with the aim of determining the effect of spiritual self-care training on the quality of life of mothers of preterm infants. This trial was carried out on 60 mothers with premature infants. Mothers were randomly divided into two intervention and control groups. Training for increasing awareness about the condition of the infants was carried out in both groups. In the intervention group, spiritual self-care training was also done. Data were completed in both groups before, immediately after, and two weeks after the intervention by using the standard WHO quality of life questionnaire. Data were analysed using statistical tests, including ANOVA and Repeated Measures. The results showed that the average quality of life of mothers under study was significantly different at different points of measurement in the intervention group (first, second, and third time-points) (P = 0.016). An increase was observed in the intervention group at the second time-point compared to the first time-point (84.2-88.4, P < 0.001) and in the third time-point compared to the first time-point, (87.9), which was also statistically significant (P < 0.001). According to the results of post hoc tests, there was a decrease in quality of life in the control group at the second time-point compared to the first time-point and the average score of mothers decreased from 82.9 to 75.3, which was statistically significant (P < 0.001). Spiritual self-care training can increase the quality of life and can be used as a form of holistic nursing care for mothers with premature infants in neonatal intensive care units.",2020,"According to the results of post hoc tests, there was a decrease in quality of life in the control group at the second time-point compared to the first time-point and the average score of mothers decreased from 82.9 to 75.3, which was statistically significant (P < 0.001).","['Mothers of Preterm Infants', 'mothers of preterm infants', '60 mothers with premature infants', 'mothers with premature infants in neonatal intensive care units']","['Spiritual Self-care Training', 'Spiritual self-care training', 'spiritual self-care training']","['Quality of Life', 'standard WHO quality of life questionnaire', 'quality of life', 'average quality of life of mothers under study']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0034380'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0231232,"According to the results of post hoc tests, there was a decrease in quality of life in the control group at the second time-point compared to the first time-point and the average score of mothers decreased from 82.9 to 75.3, which was statistically significant (P < 0.001).","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Sekhavatpour', 'Affiliation': 'Department of Anesthesiology, School of Paramedicine, Dezful University of Medical Sciences, Dezful, Iran.'}, {'ForeName': 'Tayebe', 'Initials': 'T', 'LastName': 'Reyhani', 'Affiliation': 'Nursing Faculty, Mashhad University of Medical Sciences, Doctora St, Mashhad, Iran. ReyhaniT@mums.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Heidarzade', 'Affiliation': 'Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seied Mehdi', 'Initials': 'SM', 'LastName': 'Moosavi', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Seied Reza', 'Initials': 'SR', 'LastName': 'Mazlom', 'Affiliation': 'Nursing Faculty, Mashhad University of Medical Sciences, Doctora St, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Dastoorpoor', 'Affiliation': 'Air Pollution and Respiratory Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mansoure', 'Initials': 'M', 'LastName': 'Karimollahi', 'Affiliation': 'Faculty of Nursing and Midwifery, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Khanjani', 'Affiliation': 'Neurology Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}]",Journal of religion and health,['10.1007/s10943-018-0620-4']
514,30218372,The Effect of Religious Intervention Using Prayer for Quality of Life and Psychological Status of Patients with Permanent Pacemaker.,"The development of heart disease, followed by the pacemaker implantation, has reduced the quality and psychological problems for patients. Thus, the present study was conducted to determine the effect of prayer on the quality of life and the psychological status of patients with permanent pacemaker. This is a quasi-experimental study in which 75 patients were assigned to experimental and control groups. Religious intervention was conducted for the experimental group, including the Tavasol prayer and four recommended (mustahab) remembrances in 7 sessions. Before and after the intervention, the patients were provided with the quality of life questionnaire and psychological status. Then, the questionnaires were analyzed using descriptive and analytical tests. Before intervention, there was no difference between quality of life status and psychological status of patients, but after intervention, their quality of life increased and their psychological status improved significantly. The implementation of religious intervention based on prayer positively affects the quality of life and psychological status of patients; thus, implementing this intervention is necessary for patients.",2020,"Before intervention, there was no difference between quality of life status and psychological status of patients, but after intervention, their quality of life increased and their psychological status improved significantly.","['Patients with Permanent Pacemaker', 'patients with permanent pacemaker', '75 patients']","['Religious Intervention', 'Religious intervention']","['quality of life status and psychological status', 'quality and psychological problems', 'quality of life questionnaire and psychological status', 'quality of life and psychological status', 'Quality of Life and Psychological Status', 'quality of life increased and their psychological status', 'quality of life and the psychological status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}]","[{'cui': 'C0557075', 'cui_str': 'Has religious belief (finding)'}]","[{'cui': 'C0034380'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",75.0,0.0148155,"Before intervention, there was no difference between quality of life status and psychological status of patients, but after intervention, their quality of life increased and their psychological status improved significantly.","[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Naimi', 'Affiliation': 'Department of Public Health, Faulty of Health, Yasuj University of Medical Science, Yasuj, Iran.'}, {'ForeName': 'Owrang', 'Initials': 'O', 'LastName': 'Eilami', 'Affiliation': 'School of Medicine Social, Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Babuei', 'Affiliation': 'Deputy of Development of Management, Yasuj University of Medical Science, Yasuj, Iran.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Rezaei', 'Affiliation': 'Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Moslem', 'Initials': 'M', 'LastName': 'Moslemirad', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Yasuj University of Medical Sciences, Yasuj, Iran. moslemi.moslem2016@yahoo.com.'}]",Journal of religion and health,['10.1007/s10943-018-0698-8']
515,32114185,Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial.,"IMPORTANCE
Extant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design.
DESIGN
2-arm randomized controlled efficacy-effectiveness trial.
SETTING
A large non-profit health maintenance organization.
PARTICIPANTS
165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider.
INTERVENTIONS
Two sleep interventions, each 6-7 sessions, both overlaying ""treatment as usual"" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI).
CONCLUSIONS AND RELEVANCE
If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
TRIAL REGISTRATION
clinicaltrials.gov, NCT02290496, https://clinicaltrials.gov/ct2/show/NCT02290496.",2020,"If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
","['youth', 'A large non-profit health maintenance organization', '165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider']","['cognitive behavioral therapy', 'overlaying ""treatment as usual"" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI', 'SSRI antidepressants']",['depression outcomes'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018720', 'cui_str': 'Prepaid Group Health Organizations'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035168'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0565959', 'cui_str': 'New episode (qualifier value)'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0444456', 'cui_str': 'Overlay (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",165.0,0.0962211,"If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
","[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Greg.Clarke@kpchr.org.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Sheppler', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Christina.R.Sheppler@kpchr.org.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Firemark', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Alison.J.Firemark@kpchr.org.'}, {'ForeName': 'Andreea M', 'Initials': 'AM', 'LastName': 'Rawlings', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Andreea.M.Rawlings@kpchr.org.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dickerson', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: John.F.Dickerson@kpchr.org.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Michael.C.Leo@kpchr.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105967']
516,32114186,Feasibility and preliminary effects of a peer-led motivationally-embellished workplace walking intervention: A pilot cluster randomized trial (the START trial).,"Walking interventions can be effective in increasing physical activity amongst physically inactive employees. However, despite their promising potential regarding sustainability and scalability, peer-led workplace walking interventions have not been tested. We evaluated a peer-led workplace group walking intervention designed to engage physically inactive employees. A 16-week pilot cluster randomized controlled trial consisted of enhanced (5 worksites; n = 50 participants) and minimal treatment (3 worksites; n = 47) conditions. All participants were provided with a Fitbit Zip and information on health benefits of walking. Enhanced treatment participants had access to a mobile phone app incorporating behavior change techniques, were trained on principles of autonomous motivation, and had a peer leader trained in a motivationally supportive communication style. Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only). Outcomes assessed included movement-related behaviors (assessed via activPAL devices), cardio-metabolic risk factors, motivation to walk, and well-being, and these measures were taken at baseline and post-intervention. The results supported intervention feasibility. Preliminary efficacy evidence was mixed. Markers of cardio-metabolic risk improved in the enhanced treatment only. Autonomous motivation increased in both conditions. There were no changes in step counts, standing, and sitting time, or well-being. Further fine tuning is needed before a definitive RCT. Australian and New Zealand Clinical Trials Registry: ACTRN12618000807257.",2020,"Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only).",['Australian and New Zealand'],"['enhanced (5 worksites; n\u202f=\u202f50 participants) and minimal treatment (3 worksites; n\u202f=\u202f47) conditions', 'peer-led workplace group walking intervention', 'peer-led motivationally-embellished workplace walking intervention', 'Walking interventions']","['step counts, standing, and sitting time, or well-being', 'Markers of cardio-metabolic risk', 'Autonomous motivation', 'movement-related behaviors (assessed via activPAL devices), cardio-metabolic risk factors, motivation to walk, and well-being, and these measures', 'Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0043016', 'cui_str': 'Walkers'}]",50.0,0.113263,"Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia. Electronic address: c.thogersen@curtin.edu.au.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Smith', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nicholas', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, Australia.'}, {'ForeName': 'S A M', 'Initials': 'SAM', 'LastName': 'Fenton', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, England.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Charles Perkins Centre, School of Public Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Centre for Transformative Work Design, Future of Work Institute, Curtin University, Perth, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105969']
517,32087340,"The OaSiS trial: A hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer.","INTRODUCTION
When the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guidelines for Treating Tobacco Use and Dependence during CT screening for lung cancer.
METHODS AND DESIGN
OaSiS was implemented using a pragmatic effectiveness-implementation hybrid design in 26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP). The 26 sites selected for participation in the OaSiS trial were randomized to receive either a compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care. Usual care sites were given the option to receive the full compendium of implementation strategies at the conclusion of data collection. We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
DISCUSSION
The OaSiS trial was designed to identify opportunities for implementing evidence-based smoking cessation into LDCT lung cancer screening imaging facilities and to establish the effectiveness of these services. We report our study design and evaluation, including strengths of the pragmatic design and the inclusion of a diverse range of screening programs. Establishing these tobacco cessation services will be critical to reducing smoking related morbidity and mortality.",2020,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","['patients undergoing LDCT screening', ""26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP"", '26 sites selected for participation in the OaSiS trial', 'for lung cancer']","['compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care', 'smoking cessation during CT screening']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035168'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],26.0,0.0444411,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","[{'ForeName': 'Kristie Long', 'Initials': 'KL', 'LastName': 'Foley', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America. Electronic address: kfoley@wakehealth.edu.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Weaver', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Sutfin', 'Affiliation': 'Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'W Jeffrey', 'Initials': 'WJ', 'LastName': 'Petty', 'Affiliation': 'Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bellinger', 'Affiliation': 'Pulmonology and Critical Care, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spangler', 'Affiliation': 'Family and Community Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stone', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lawler', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Davis', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dressler', 'Affiliation': 'Biostatistics and Data Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Lesser', 'Affiliation': 'Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chiles', 'Affiliation': 'Radiology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105963']
518,32087342,"The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight.","BACKGROUND
Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors.
PURPOSE
Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older.
METHODS
Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months.
CONCLUSIONS
If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs.",2020,"We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol.","['530 adults, ages 18 and older']","['1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM\u202f+\u202fFB, where participants self-monitor and receive real-time, tailored feedback (FB']",['weight loss'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",530.0,0.0361057,"We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol.","[{'ForeName': 'Lora E', 'Initials': 'LE', 'LastName': 'Burke', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America. Electronic address: lbu100@pitt.edu.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Bambang', 'Initials': 'B', 'LastName': 'Parmanto', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Britney', 'Initials': 'B', 'LastName': 'Beatrice', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Cajita', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'India', 'Initials': 'I', 'LastName': 'Loar', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'I Wayan', 'Initials': 'IW', 'LastName': 'Pulantara', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Kariuki', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Cedillo', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'University of Pittsburgh, Graduate School of Public Health, Department of Epidemiology, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105958']
519,32092321,"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide at a Dose of 30 μg/kg Ideal Body Weight/hr in Subjects at Risk of Pulmonary Hypertension Associated With Pulmonary Fibrosis Receiving Oxygen Therapy.","BACKGROUND
The interstitial lung diseases include a variety of disorders, many of which are characterized by fibrotic changes (fILD). Of the fILDs, Idiopathic pulmonary fibrosis is the most common. Pulmonary hypertension (PH) frequently complicates fILD and is associated with impaired functional capability, lower physical activity, and significantly reduced life expectancy. There is no proven treatment for patients with fILD-PH. We report results from the first cohort of a phase 2b/3 trial with pulsed inhaled nitric oxide (iNO) in patients with fILD-PH.
METHODS
Subjects in cohort 1 were randomized to iNO 30 μg/kg ideal body weight/hr (iNO30) or placebo for 8 weeks of blinded treatment; subjects then transitioned to open-label extension (OLE) on iNO30 followed by dose escalation to iNO45 then iNO75. Activity monitoring was used to assess changes in daily activity. Safety and efficacy were evaluated.
RESULTS
Twenty-three patients were randomized to iNO30 and 18 to placebo. During blinded treatment, iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity. Placebo subjects showed an average drop of 26% in MVPA and a 12% drop in overall activity. The iNO group had an improvement in oxygen saturation. During OLE, subjects maintained their activity levels including placebo subjects who transitioned from a decline to a maintenance in all activity parameters. Inhaled nitric oxide at all doses (30, 45, and 75) was safe and well tolerated.
CONCLUSIONS
Treatment with iNO30 demonstrated clinically and statistically significant benefit in MVPA and clinically significant benefit in overall activity. In the OLE, higher doses of iNO were also safe and well tolerated while showing maintenance in activity parameters.",2020,During blinded treatment iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity.,"['subjects at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF) receiving Oxygen Therapy', 'patients with fILD-PH', 'patients with fILD-PH.\nMETHODS\n\n\nSubjects in Cohort 1']","['iNO 30 mcg/kg IBW/hr (iNO30) or placebo', 'placebo', 'pulsed, inhaled nitric oxide (iNO', 'pulsed iNO', 'Placebo']","['safety and efficacy', 'overall activity', 'activity levels', 'Safety and efficacy', 'oxygen saturation', 'safe and well tolerated', 'moderate/vigorous physical activity (MVPA']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0034069', 'cui_str': 'Pulmonary Fibrosis'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",23.0,0.139946,During blinded treatment iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity.,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'Advanced Lung Disease and Transplant Program, Inova Heart and Vascular Institute, Inova Fairfax Hospital, Richmond, VA; Virginia Commonwealth University, Richmond, VA. Electronic address: steven.nathan@inova.org.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Marilyn K', 'Initials': 'MK', 'LastName': 'Glassberg', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'the University of Arizona College of Medicine - Phoenix and Banner; University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Swigris', 'Affiliation': 'Department of Medicine, National Jewish, Denver, CO.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Alvarez', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ettinger', 'Affiliation': 'The Lung Research Center-Missouri, Chesterfield, MO.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Loyd', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fernandes', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Gillies', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lancaster', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}]",Chest,['10.1016/j.chest.2020.02.016']
520,29045520,"Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma.","Background
Primary analysis of the double-blind, phase III Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (EXAM) trial demonstrated significant improvement in progression-free survival with cabozantinib versus placebo in patients with progressive medullary thyroid cancer (MTC). Final analysis of overall survival (OS), a key secondary endpoint, was carried out after long-term follow-up.
Patients and methods
EXAM compared cabozantinib with placebo in 330 patients with documented radiographic progression of metastatic MTC. Patients were randomized (2:1) to cabozantinib (140 mg/day) or placebo. Final OS and updated safety data are reported.
Results
Minimum follow-up was 42 months. Kaplan-Meier analysis showed a 5.5-month increase in median OS with cabozantinib versus placebo (26.6 versus 21.1 months) although the difference did not reach statistical significance [stratified hazard ratio (HR), 0.85; 95% confidence interval (CI), 0.64-1.12; P = 0.24]. In an exploratory assessment of OS, progression-free survival, and objective response rate, cabozantinib appeared to have a larger treatment effect in patients with RET M918T mutation-positive tumors compared with patients not harboring this mutation. For patients with RET M918T-positive disease, median OS was 44.3 months for cabozantinib versus 18.9 months for placebo [HR, 0.60; 95% CI, 0.38-0.94; P = 0.03 (not adjusted for multiple subgroup analyses)], with corresponding values of 20.2 versus 21.5 months (HR, 1.12; 95% CI, 0.70-1.82; P = 0.63) in the RET M918T-negative subgroup. Median treatment duration was 10.8 months with cabozantinib and 3.4 months with placebo. The safety profile for cabozantinib remained consistent with that of the primary analysis.
Conclusion
The secondary end point was not met in this final OS analysis from the trial of cabozantinib in patients with metastatic, radiographically progressive MTC. A statistically nonsignificant increase in OS was observed for cabozantinib compared with placebo. Exploratory analyses suggest that patients with RET M918T-positive tumors may experience a greater treatment benefit with cabozantinib.
Trial Registration Number
NCT00704730.",2017,"Kaplan-Meier analysis showed a 5.5-month increase in median OS with cabozantinib versus placebo (26.6 versus 21.1 months) although the difference did not reach statistical significance [stratified hazard ratio (HR), 0.85; 95% confidence interval (CI), 0.64-1.12; P = 0.24].","['patients with RET M918T-positive tumors', 'patients with radiographically progressive medullary thyroid carcinoma', 'Advanced Medullary Thyroid Cancer (EXAM', '330 patients with documented radiographic progression of metastatic MTC', 'patients with progressive medullary thyroid cancer (MTC']","['XL184 (Cabozantinib', 'cabozantinib versus placebo', 'placebo', 'cabozantinib']","['OS, progression-free survival, and objective response rate', 'Median treatment duration', 'OS', 'progression-free survival', 'median OS', 'overall survival (OS', 'Overall survival analysis of EXAM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0238462', 'cui_str': 'Medullary thyroid cancer (MTC)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}]",330.0,0.52668,"Kaplan-Meier analysis showed a 5.5-month increase in median OS with cabozantinib versus placebo (26.6 versus 21.1 months) although the difference did not reach statistical significance [stratified hazard ratio (HR), 0.85; 95% confidence interval (CI), 0.64-1.12; P = 0.24].","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schlumberger', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy and University Paris-Saclay, Villejuif, France. Electronic address: martin.schlumberger@gustaveroussy.fr.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Elisei', 'Affiliation': 'Endocrine Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Department of General Medical Oncology, KU Leuven, Leuven; Laboratory of Experimental Oncology at the University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brose', 'Affiliation': 'Department of Otorhinolaryngology: Head and Neck Surgery, Abramson Cancer Center of the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'IRCCS Foundation, National Cancer Institute, Milan; University of Milan, Milan, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krajewska', 'Affiliation': 'Maria Skłodowska-Curie Memorial Institute - Cancer Center Gliwice Branch, Gliwice, Poland.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Kreissl', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Niederle', 'Affiliation': 'Division of Surgical Endocrinology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'E E W', 'Initials': 'EEW', 'LastName': 'Cohen', 'Affiliation': 'University of California San Diego Moores Cancer Center, La Jolla.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wirth', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Henry Ford Health System, Detroit.'}, {'ForeName': 'D O', 'Initials': 'DO', 'LastName': 'Clary', 'Affiliation': 'Exelixis, Inc, South San Francisco.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yaron', 'Affiliation': 'Exelixis, Inc, South San Francisco.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mangeshkar', 'Affiliation': 'Exelixis, Inc, South San Francisco.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ball', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Nelkin', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine, Baltimore.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'Department of Endocrine Neoplasia and Hormonal Disorders, University of Texas MD Anderson Cancer Center, Houston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx479']
521,29045529,Impact of genetic variations in the MAPK signaling pathway on outcome in metastatic colorectal cancer patients treated with first-line FOLFIRI and bevacizumab: data from FIRE-3 and TRIBE trials.,"Background
The MAPK-interacting kinase 1 (MKNK1) is localized downstream of the RAS/RAF/ERK and the MAP3K1/MKK/p38 signaling pathway. Through phosphorylation MKNK1 regulates the function of eukaryotic translation initiation factor 4E, a key player in translational control, whose expression is often upregulated in metastatic colorectal cancer patients (mCRC). Preclinical data suggest that MKNK1 increases angiogenesis by upregulating angiogenic factors. We therefore hypothesize that variations in the MKNK1 gene predict outcome in mCRC patients treated with first-line FOLFIRI and bevacizumab (bev).
Patients and methods
A total of 567 patients with KRAS wild-type mCRC in the randomized phase III FIRE-3 and TRIBE trials treated with first-line FOLFIRI/bev (discovery and validation cohorts) or FOLFIRI and cetuximab (cet) (control cohort) were included in this study. Five single-nucleotide polymorphisms in the MAPK signaling pathway were analyzed.
Results
AA genotype carriers of the MKNK1 rs8602 single-nucleotide polymorphism treated with FOLFIRI/bev in the discovery cohort (FIRE-3) had a shorter progression-free survival (PFS) than those harboring any C (7.9 versus 10.3 months, Hazard ratio (HR) 1.73, P = 0.038). This association could be confirmed in the validation cohort (TRIBE) in multivariable analysis (PFS 9.0 versus 11.0 months, HR 3.04, P = 0.029). Furthermore, AA carriers in the validation cohort had a decreased overall response rate (25% versus 66%, P = 0.049). Conversely, AA genotype carriers in the control group receiving FOLFIRI/cet did not show a shorter PFS. By combining both FOLFIRI/bev cohorts the worse outcome among AA carriers became more significant (PFS 9.0 versus 10.5 months) in univariable (HR 1.74, P = 0.015) and multivariable analysis (HR 1.76, P = 0.022). Accordingly, AA carriers did also exhibit an inferior overall response rate compared with those harboring any C (36% versus 65%, P = 0.005).
Conclusion
MKNK1 polymorphism rs8602 might serve as a predictive marker in KRAS wild-type mCRC patients treated with FOLFIRI/bev in the first-line setting. Additionally, MKNK1 might be a promising target for drug development.",2017,"Conversely, AA genotype carriers in the control group receiving FOLFIRI/cet did not show a shorter PFS.","['metastatic colorectal cancer patients treated with first-line FOLFIRI and', '567 patients with KRAS wild-type mCRC', 'metastatic colorectal cancer patients (mCRC']","['first-line FOLFIRI/bev (discovery and validation cohorts) or FOLFIRI and cetuximab (cet) (control cohort', 'MKNK1', 'bevacizumab']","['Hazard ratio (HR', 'overall response rate', 'shorter progression-free survival (PFS', 'inferior overall response rate']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}]",567.0,0.0761289,"Conversely, AA genotype carriers in the control group receiving FOLFIRI/cet did not show a shorter PFS.","[{'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Berger', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sunakawa', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Matsusaka', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Okazaki', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Suenaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Soni', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'U.O. Oncologia Medica, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, USA;. Electronic address: lenz@usc.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx412']
522,29045553,Randomized controlled trial of S-1 versus docetaxel in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy (East Asia S-1 Trial in Lung Cancer).,"Background
Chemotherapy remains a viable option for the management of advanced non-small-cell lung cancer (NSCLC) despite recent advances in molecular targeted therapy and immunotherapy. We evaluated the efficacy of oral 5-fluorouracil-based S-1 as second- or third-line therapy compared with standard docetaxel therapy in patients with advanced NSCLC.
Patients and methods
Patients with advanced NSCLC previously treated with ≥1 platinum-based therapy were randomized 1 : 1 to docetaxel (60 mg/m2 in Japan, 75 mg/m2 at all other study sites; day 1 in a 3-week cycle) or S-1 (80-120 mg/day, depending on body surface area; days 1-28 in a 6-week cycle). The primary endpoint was overall survival. The non-inferiority margin was a hazard ratio (HR) of 1.2.
Results
A total of 1154 patients (577 in each arm) were enrolled, with balanced patient characteristics between the two arms. Median overall survival was 12.75 and 12.52 months in the S-1 and docetaxel arms, respectively [HR 0.945; 95% confidence interval (CI) 0.833-1.073; P = 0.3818]. The upper limit of 95% CI of HR fell below 1.2, confirming non-inferiority of S-1 to docetaxel. Difference in progression-free survival between treatments was not significant (HR 1.033; 95% CI 0.913-1.168; P = 0.6080). Response rate was 8.3% and 9.9% in the S-1 and docetaxel arms, respectively. Significant improvement was observed in the EORTC QLQ-C30 global health status over time points in the S-1 arm. The most common adverse drug reactions were decreased appetite (50.4%), nausea (36.4%), and diarrhea (35.9%) in the S-1 arm, and neutropenia (54.8%), leukocytopenia (43.9%), and alopecia (46.6%) in the docetaxel arm.
Conclusion
S-1 is equally as efficacious as docetaxel and offers a treatment option for patients with previously treated advanced NSCLC.
Clinical trial number
Japan Pharmaceutical Information Center, JapicCTI-101155.",2017,Significant improvement was observed in the EORTC QLQ-C30 global health status over time points in the S-1 arm.,"['East Asia S-1 Trial in Lung Cancer', '1154 patients (577 in each arm) were enrolled, with balanced patient characteristics between the two arms', 'patients with non-small-cell lung cancer previously treated with', 'patients with previously treated advanced NSCLC', 'Patients and methods\n\n\nPatients with advanced NSCLC previously treated with\u2009≥1 platinum-based therapy', 'patients with advanced NSCLC']","['oral 5-fluorouracil-based S-1 as second- or third-line therapy', 'platinum-based chemotherapy', '\n\n\nChemotherapy', 'standard docetaxel therapy', 'docetaxel', 'S-1 versus docetaxel']","['nausea', 'EORTC QLQ-C30 global health status', 'progression-free survival', 'leukocytopenia', 'neutropenia', 'Response rate', 'appetite', 'diarrhea', 'Median overall survival', 'overall survival', 'alopecia']","[{'cui': 'C0015631', 'cui_str': 'East Asia'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0023530', 'cui_str': 'Leukocytopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}]",1154.0,0.183693,Significant improvement was observed in the EORTC QLQ-C30 global health status over time points in the S-1 arm.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nokihara', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai.'}, {'ForeName': 'T S K', 'Initials': 'TSK', 'LastName': 'Mok', 'Affiliation': 'Department of Clinical Oncology, State Key Laboratory in Oncology in South China, The Chinese University of Hong Kong, Hong Kong, China. Electronic address: tony@clo.cuhk.edu.hk.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'Department of Hematology-Oncology, National University Hospital, Cancer Science Institute of Singapore, Singapore.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maemondo', 'Affiliation': 'Department of Thoracic Oncology, Miyagi Cancer Center, Miyagi.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ichinose', 'Affiliation': 'Department of Cancer Information Research, National Kyushu Cancer Center, Clinical Research Institute, Fukuoka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Lim', 'Affiliation': 'Department of Medical Oncology, National Cancer Center Singapore, Singapore.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': ""Thoracic Center, St Luke's International Hospital, Tokyo, Japan.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx419']
523,32231293,Dose-dense adjuvant chemotherapy in early breast cancer patients: 15-year results of the Phase 3 Mammella InterGruppo (MIG)-1 study.,"BACKGROUND
Adjuvant chemotherapy is the standard of care in high-risk early breast cancer patients. Dose-dense should be the preferred schedule of administration. However, its long-term benefit is unknown.
METHODS
In the Italian multicentre Phase 3 randomised MIG-1 trial, node-positive and high-risk node- negative breast cancer patients were randomised to receive six cycles of adjuvant fluorouracil, epirubicin and cyclophosphamide regimen administered every 3 (FEC21) or 2 (FEC14) weeks. The primary endpoint was overall survival (OS), and the secondary endpoint was event-free survival (EFS).
RESULTS
From 1992 to 1997, 1214 patients were included. Median follow-up was 15.8 years. In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25). In all, 15-year EFS was 47% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.87; p = 0.18). In a pre-planned subgroup analysis, among patients with hormone receptor-negative tumours, 15-year OS was 70% and 65% in the FEC14 and FEC21 groups, respectively (HR = 0.73; 95% CI: 0.51-1.06); 15-year EFS was 58% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.70; 95% CI: 0.51-0.96).
CONCLUSIONS
Updated results from the MIG-1 study are numerically in favour of dose-dense chemotherapy, and suggest a long-term benefit of this approach in high-risk early breast cancer patients.",2020,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","['From 1992 to 1997, 1214 patients were included', 'node-positive and high-risk node- negative breast cancer patients', 'high-risk early breast cancer patients', 'early breast cancer patients']","['adjuvant fluorouracil, epirubicin and cyclophosphamide', 'Dose-dense adjuvant chemotherapy']","['15-year OS', 'overall survival (OS), and the secondary endpoint was event-free survival (EFS', '15-year EFS']","[{'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",1214.0,0.167571,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Blondeaux', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Michelotti', 'Affiliation': 'Department of Oncology, Transplants and new Technologies U.O. Oncologia Medica I, Ospedale S. Chiara, Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 56100, Pisa, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Medical Oncology, Ospedale San Paolo, Via Genova 30, 17100, Savona, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dellepiane', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bighin', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pastorino', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Levaggi', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': ""Alessia D'"", 'Initials': 'A', 'LastName': 'Alonzo', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Buzzatti', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Molinelli', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Fregatti', 'Affiliation': 'Department of Integrated Diagnostic Surgical Sciences, U.O. Clinica di chirurgia senologica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bertoglio', 'Affiliation': 'Department of Surgical Sciences (DISC), University of Genova, Largo Rosanna Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy. lucia.delmastro@hsanmartino.it.'}]",British journal of cancer,['10.1038/s41416-020-0816-8']
524,32064639,"Combining whole-school and targeted programs for the reduction of bullying victimization: A randomized, effectiveness trial.","Despite the extensive evaluation of school-based interventions for bullying, victimization remains a significant problem in schools. Bullying victimization is significantly predicted by contextual (school-related) factors. As a consequence whole-school programs have been commonly used to prevent and reduce bullying victimization. Evidence also points to individual risk factors (such as emotional distress) in predicting victimization, yet programs to prevent bullying victimization by changing these individual risks are far less developed. Few studies have approximated ""real-world"" implementation conditions in their trials. The current effectiveness trial evaluated the combination of a whole-school program designed to prevent bullying perpetration and victimization together with a targeted intervention for at-risk students, teaching them individual and dyadic strategies to reduce their anxiety and manage victimization, allowing schools some latitude to implement programs as they typically would. Students from Grades 3 and 4 (N = 8,732) across 135 schools were randomly assigned to one of four conditions: combined intervention; whole-school intervention only; individual intervention only; and care as usual. Victimization decreased significantly and similarly across all four conditions at 12 and 24 months following baseline. Similar reductions and failure to discriminate conditions were found on other key constructs: anxiety; bullying perpetration; and depression. Possible reasons for the failure to demonstrate victimization prevention differences and lessons learned from this large, effectiveness trial are considered.",2020,Similar reductions and failure to discriminate conditions were found on other key constructs: anxiety; bullying perpetration; and depression.,"['Students from Grades 3 and 4 (N\u2009=\u20098,732) across 135 schools']",['combined intervention; whole-school intervention only; individual intervention only; and care as usual'],"['Bullying victimization', 'Victimization']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",,0.0274574,Similar reductions and failure to discriminate conditions were found on other key constructs: anxiety; bullying perpetration; and depression.,"[{'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Shaw', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'School of Psychology, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Bussey', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hudson', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin Health Economics, Centre for Population Health Research, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Radom', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cordin', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Epstein', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Cross', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}]",Aggressive behavior,['10.1002/ab.21881']
525,32246229,Feasibility and Efficacy of the Addition of Heart Rate Variability Biofeedback to a Remote Digital Health Intervention for Depression.,"A rise in the prevalence of depression underscores the need for accessible and effective interventions. The objectives of this study were to determine if the addition of a treatment component showing promise in treating depression, heart rate variability-biofeedback (HRV-B), to our original smartphone-based, 8-week digital intervention was feasible and whether patients in the HRV-B (""enhanced"") intervention were more likely to experience clinically significant improvements in depressive symptoms than patients in our original (""standard"") intervention. We used a quasi-experimental, non-equivalent (matched) groups design to compare changes in symptoms of depression in the enhanced group (n = 48) to historical outcome data from the standard group (n = 48). Patients in the enhanced group completed a total average of 3.86 h of HRV-B practice across 25.8 sessions, and were more likely to report a clinically significant improvement in depressive symptom score post-intervention than participants in the standard group, even after adjusting for differences in demographics and engagement between groups (adjusted OR 3.44, 95% CI [1.28-9.26], P = .015). Our findings suggest that adding HRV-B to an app-based, smartphone-delivered, remote intervention for depression is feasible and may enhance treatment outcomes.",2020,"Patients in the enhanced group completed a total average of 3.86 h of HRV-B practice across 25.8 sessions, and were more likely to report a clinically significant improvement in depressive symptom score post-intervention than participants in the standard group, even after adjusting for differences in demographics and engagement between groups (adjusted OR 3.44, 95% CI [1.28-9.26], P = .015).",[],"['HRV-B (""enhanced"") intervention', 'Heart Rate Variability Biofeedback to a Remote Digital Health Intervention']","['treating depression, heart rate variability-biofeedback (HRV-B', 'depressive symptoms', 'depressive symptom score']",[],"[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.101252,"Patients in the enhanced group completed a total average of 3.86 h of HRV-B practice across 25.8 sessions, and were more likely to report a clinically significant improvement in depressive symptom score post-intervention than participants in the standard group, even after adjusting for differences in demographics and engagement between groups (adjusted OR 3.44, 95% CI [1.28-9.26], P = .015).","[{'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Economides', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lehrer', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ranta', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Nazander', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Hilgert', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Raevuori', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gevirtz', 'Affiliation': 'Department of Clinical Psychology, California School of Professional Psychology, Alliant University, San Diego, USA.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Khazan', 'Affiliation': 'Harvard Medical School, Boston Center for Health Psychology and Biofeedback, Boston, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Forman-Hoffman', 'Affiliation': 'Meru Health Inc, Palo Alto, CA, USA. valerie@meruhealth.com.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09458-z']
526,32151753,Design of a home-based intervention for Houston-area African-American adults with asthma: Methods and lessons learned from a pragmatic randomized trial.,"A growing body of evidence demonstrates that home-based, multicomponent interventions can effectively reduce exposures to asthma triggers and decrease asthma symptoms. However, few of these studies have targeted adults. To address this and other research gaps, we designed and implemented a pragmatic randomized clinical trial, the Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans, to assess the effectiveness of a home-based intervention to improve asthma control and quality of life in African-American adults-a population disproportionately affected by asthma. The primary goals were to help participants reduce allergens and irritants in their homes and better manage their disease through knowledge, improved medication use, and behavior change. HIITBAC had two groups: clinic-only and home-visit groups. Both groups received enhanced clinical care, but the home-visit group also received a detailed home assessment and four additional home visits spaced over roughly one year. We recruited 263 participants. Of these, 152 (57.8%) were recruited through electronic health record data, 51 (19.4%) through Emergency Medical Services data, and 60 (22.8%) through other efforts (e.g., emergency departments, community events, outreach). Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group. We describe the HIITBAC methodology and cohort, discuss lessons learned about recruitment and retention, and highlight adaptations we implemented to address these lessons.",2020,"Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group.","['152 (57.8%) were recruited through electronic health record data, 51 (19.4%) through Emergency Medical Services data, and 60 (22.8%) through other efforts (e.g., emergency departments, community events, outreach', 'African-American adults-a population disproportionately affected by asthma', 'HIITBAC had two groups: clinic-only and home-visit groups', 'Houston-area African-American adults with asthma', '263 participants', 'Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group', 'African Americans']","['home-based intervention', 'Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC']","['allergens and irritants in their homes and better manage their disease through knowledge, improved medication use, and behavior change', 'asthma control and quality of life']","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0348027', 'cui_str': 'Irritant (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}]",263.0,0.076198,"Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group.","[{'ForeName': 'Rebecca Jensen', 'Initials': 'RJ', 'LastName': 'Bruhl', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States. Electronic address: Rebecca.J.Bruhl@bcm.edu.'}, {'ForeName': 'William Brett', 'Initials': 'WB', 'LastName': 'Perkison', 'Affiliation': 'Department of Epidemiology, Human Genetics and Environmental Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Lorna H', 'Initials': 'LH', 'LastName': 'McNeill', 'Affiliation': 'Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Abiodun O', 'Initials': 'AO', 'LastName': 'Oluyomi', 'Affiliation': 'Section of Epidemiology and Population Science, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Ellen Baskin', 'Initials': 'EB', 'LastName': 'Fiesinger', 'Affiliation': 'Department of Management, Policy and Community Health, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Abida', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'College of Nursing, Prairie View A&M University, Houston, TX, United States.'}, {'ForeName': 'Winifred J', 'Initials': 'WJ', 'LastName': 'Hamilton', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Butler', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Caldwell', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Crosby', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Cellie', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Galvan', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': ""Frene'"", 'Initials': 'F', 'LastName': 'Lacour-Chestnut', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Shereda', 'Initials': 'S', 'LastName': 'Pannell', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Phipps', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Adriene', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'White', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Boles', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Rangel', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Ritupreet', 'Initials': 'R', 'LastName': 'Virk', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Guffey', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Ramamurthy', 'Affiliation': 'Office of Research Information Technology, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Persse', 'Affiliation': 'Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, United States; Emergency Medical Services, Houston Fire Department, City of Houston, TX, United States.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Maffei', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Wenyaw', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Department of Biostatistics, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Reyes', 'Affiliation': 'U.S. Department of Housing & Urban Development, Washington, DC, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105977']
527,32171937,Movement pattern biofeedback training after total knee arthroplasty: Randomized clinical trial protocol.,"INTRODUCTION
Total knee arthroplasty (TKA) reduces joint symptoms, but habitual movement compensations persist years after surgery. Preliminary research on movement training interventions have signaled initial efficacy for remediating movement compensations and restoring knee joint loading symmetry during dynamic functional tasks after TKA. The purpose of this clinical trial is to determine if physical rehabilitation that includes movement training restores healthy movement patterns after TKA and reduces the risk of osteoarthritis (OA) progression in the contralateral knee.
METHODS/DESIGN
150 participants will be enrolled into this randomized controlled trial. Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL). Movement training will promote between-limb symmetry and surgical knee loading during activity-based exercises. Movement training strategies will include real-time biofeedback using in-shoe pressure sensors and verbal, visual, and tactile cues from the physical therapist. The primary outcome will be change in peak knee extension moment in the surgical knee during walking, from before surgery to six months after surgery. Secondary outcomes will include lower extremity movement symmetry during functional tasks, physical function, quadriceps strength, range of motion, satisfaction, adherence, contralateral knee OA progression, and incidence of contralateral TKA.
DISCUSSION
This study will provide insights into the efficacy of movement training after unilateral TKA, along with mechanisms for optimizing long-term physical function and minimizing negative sequelae of compensatory movement patterns.",2020,Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL).,"['150 participants', 'total knee arthroplasty']","['Movement training', 'standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL', 'TKA', 'Total knee arthroplasty (TKA', 'Movement pattern biofeedback training']","['lower extremity movement symmetry during functional tasks, physical function, quadriceps strength, range of motion, satisfaction, adherence, contralateral knee OA progression, and incidence of contralateral TKA', 'risk of osteoarthritis (OA) progression', 'peak knee extension moment in the surgical knee during walking']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",150.0,0.0895054,Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bade', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America. Electronic address: michael.bade@ucdenver.edu.'}, {'ForeName': 'Jesse C', 'Initials': 'JC', 'LastName': 'Christensen', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Zeni', 'Affiliation': 'Rutgers University, School of Health Professions, Newark, NJ, United States of America.'}, {'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Christiansen', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Dayton', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America.'}, {'ForeName': 'Jeri E', 'Initials': 'JE', 'LastName': 'Forster', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Veterans Affairs Rocky Mountain Mental Illness, Research, Education and Clinical Center, VA Eastern Colorado Healthcare System, Aurora, CO, United States of America.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'Cheuy', 'Affiliation': 'University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapsley', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105973']
528,32092439,Evaluating the effect of individually-targeted food incentives on grocery purchases: The smart cart study protocol for a randomized controlled cross-over trial.,"BACKGROUND/AIMS
Health stakeholders are interested in the promise of healthy food incentives to improve dietary quality. The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
DESIGN
Randomized controlled crossover design of 224 adults who shopped at an independent supermarket for ≥50% of their groceries, participated in the store's loyalty program, and completed validated diet and sociodemographic/behavioral questionnaires. Participants were randomized using 1:1 blocked randomization; all participants received a 5% discount on their purchases with their loyalty card. For the first 13-weeks, the intervention group received individually-targeted weekly coupons (valued up to $10) with brief nutrition education to improve grocery purchase quality. The study team developed healthy food coupons, and the study algorithm allocated targeted coupons to participants' loyalty cards using purchase history, dietary preferences/allergies, and baseline diet quality. Control participants received weekly untargeted nutrition education and occasional generic coupons. Following a 2-4 week washout period, the two groups crossed over. The primary study outcomes were purchases of targeted products and grocery purchase quality measured using the validated Grocery Purchase Quality Index-2016; the study was powered to detect a minimum 3% difference in purchase quality.
CONCLUSIONS
The Smart Cart Study tested a novel application of automated individually-targeted marketing using customer purchase history, dietary quality, and preferences to identify and deliver targeted incentives to improve grocery purchase quality. Future research could scale this program through collaboration between multiple stakeholders, including supermarkets, workplace wellness initiatives and insurance companies.",2020,"The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
","[""224 adults who shopped at an independent supermarket for ≥50% of their groceries, participated in the store's loyalty program, and completed validated diet and sociodemographic/behavioral questionnaires""]","['untargeted nutrition education and occasional generic coupons', 'individually-targeted weekly coupons (valued up to $10) with brief nutrition education']","['purchase quality', 'purchases of targeted products and grocery purchase quality']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0700383', 'cui_str': 'Shop (environment)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",224.0,0.0760648,"The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
","[{'ForeName': 'Maya K', 'Initials': 'MK', 'LastName': 'Vadiveloo', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston, RI, United States of America. Electronic address: Maya_vadiveloo@uri.edu.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Haley W', 'Initials': 'HW', 'LastName': 'Parker', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Perraud', 'Affiliation': 'AgroParis Tech., 75231 Paris, Ile-de-France, France.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Buchanan', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Atlas', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'General Internal Medicine Division, Department of Medicine, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105966']
529,30840084,Randomized Trial of a Positive Psychology Intervention for Adolescents With Type 1 Diabetes.,"OBJECTIVE
To evaluate the effects of a positive psychology intervention for adolescents with type 1 diabetes (T1D) on adherence, glycemic control, and quality of life.
METHODS
Adolescents with T1D (n = 120) and their caregivers were randomized to either an Education (EDU) (n = 60) or Positive Affect (PA) intervention (n = 60). Adolescents in the PA group received the intervention reminders (gratitude, self-affirmation, parental affirmation, and small gifts) via text messages or phone calls over 8 weeks. Questionnaires were completed by adolescents and caregivers and clinical data (glucometer and HbA1c) were collected at baseline 3 and 6 months. Data were analyzed using generalized linear modeling.
RESULTS
After adjusting for covariates, adolescents in the PA group demonstrated significant improvement in quality of life at 3 months, compared to the EDU group, but this was not sustained at 6 months. Similarly, the PA group showed a significant decrease in disengagement coping at 3 months but not at 6 months. There was no significant intervention effect on blood glucose monitoring, but the odds of clinically significantly improvement (checking at least one more time/day) were about twice as high in the PA group as the EDU group. No significant effects were found for glycemic control.
CONCLUSIONS
A positive psychology intervention had initial significant, positive effects on coping and quality of life in adolescents with T1D. A more intensive or longer-lasting intervention may be needed to sustain these effects and to improve adherence and glycemic control.",2019,"After adjusting for covariates, adolescents in the PA group demonstrated significant improvement in quality of life at 3 months, compared to the EDU group, but this was not sustained at 6 months.","['adolescents with T1D', 'Adolescents With Type 1 Diabetes', 'Adolescents with T1D (n\u2009=\u2009120) and their caregivers', 'adolescents with type 1 diabetes (T1D']","['Education (EDU) (n\u2009=\u200960) or Positive Affect (PA) intervention', 'positive psychology intervention', 'intervention reminders (gratitude, self-affirmation, parental affirmation, and small gifts) via text messages or phone calls over 8\u2009weeks', 'Positive Psychology Intervention']","['disengagement coping', 'coping and quality of life', 'glycemic control', 'blood glucose monitoring', 'quality of life', 'adherence, glycemic control, and quality of life']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1136188', 'cui_str': 'Gifts'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]",,0.0449269,"After adjusting for covariates, adolescents in the PA group demonstrated significant improvement in quality of life at 3 months, compared to the EDU group, but this was not sustained at 6 months.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Whittemore', 'Affiliation': 'School of Nursing, Yale University.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Choi', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Nwosu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Russell', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsz006']
530,31241541,ART in HIV-Positive Persons With Low Pretreatment Viremia: Results From the START Trial.,"BACKGROUND
The benefit of immediate antiretroviral therapy (ART) at CD4 >500 cells/μL was established in the Strategic Timing of Antiretroviral Treatment (START) study. The benefits and risks of immediate ART in participants with low pretreatment viremia, including virologic suppressors, were further assessed.
SETTING
Randomized prospective international study.
METHODS
START participants with enrollment viremia <3000 c/mL were included. We compared clinical outcomes (grade 4 adverse events, hospitalizations, or death), plasma viremia, CD4 counts, and changes in biomarkers in immediate versus deferred ART groups.
RESULTS
Participants (N = 1134 including 93 with viremia ≤50 c/mL) had a median age of 37 years, 40% were women, and median CD4 was 713 cells/µL. Ninety-seven percent in the immediate and 29% in the deferred arm initiated ART at a median of 6 and 699 days, respectively. Clinical outcomes were experienced in 64 versus 61 patients in immediate and deferred arms (hazard ratio 1.10, 95% confidence interval: 0.77 to 1.56). The CD4 count difference was 125 cells/µL at 12 and 235 cells/µL at 36 months higher in the immediate versus deferred groups. D-dimer and VCAM levels decreased, and C-reactive protein increased, in the immediate arm at month 8. No significant changes in CD4 counts or biomarkers were observed in persons who maintained spontaneous virologic suppression.
CONCLUSIONS
START participants with low enrollment viremia experienced higher CD4 counts, greater proportion with suppressed viremia, and decreases in D-dimer levels on immediate ART despite the lack of difference in serious clinical outcomes. These data support immediate ART in people with low viremia, although equipoise remains for suppressors.",2019,"D-dimer and VCAM levels decreased, and C-reactive protein increased, in the immediate arm at month 8.","['START participants with enrollment viremia <3000 c/mL were included', 'HIV-Positive Persons With Low Pretreatment Viremia', 'participants with low pretreatment viremia, including virologic suppressors', 'Participants (N = 1134 including 93 with viremia ≤50 c/mL) had a median age of 37 years, 40% were women, and median CD4 was 713 cells/µL. Ninety-seven percent in the immediate and 29% in the deferred arm']",['immediate antiretroviral therapy (ART) at CD4'],"['D-dimer and VCAM levels', 'C-reactive protein', 'CD4 counts or biomarkers', 'CD4 counts', 'clinical outcomes (grade 4 adverse events, hospitalizations, or death), plasma viremia, CD4 counts, and changes in biomarkers in immediate versus deferred ART groups', 'CD4 count difference']","[{'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",,0.406299,"D-dimer and VCAM levels decreased, and C-reactive protein increased, in the immediate arm at month 8.","[{'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Sereti', 'Affiliation': 'HIV Pathogenesis Section, NIAID/NIH, Bethesda, MD.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Gulick', 'Affiliation': 'Infectious Diseases, Weill Cornell Medicine, Weill Cornell Medical College, Cornell University, New York, NY.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': 'HIV Pathogenesis Section, NIAID/NIH, Bethesda, MD.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Migueles', 'Affiliation': 'HIV-Specific Immunity Section, NIAID/NIH, Bethesda, MD.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Palfreeman', 'Affiliation': 'Department of Genitourinary Medicine, Leicester Royal Infirmary, Leicester, United Kingdom.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Touzeau-Römer', 'Affiliation': 'Department of Immunodermatology and Infectious Skin Diseases, University Vienna General Hospital, Vienna, Austria.'}, {'ForeName': 'Waldo H', 'Initials': 'WH', 'LastName': 'Belloso', 'Affiliation': 'CICAL and Infectious Diseases Section, Internal Medicine Service, Hospital Italiano de Buenos Aires Argentina, Buenos Aires, Argentina.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Law', 'Affiliation': 'Faculty of Medicine, Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002052']
531,32250444,A Single-Centre Feasibility Randomised Controlled Trial Comparing the Incidence of Asymptomatic and Symptomatic Deep Vein Thrombosis Between a Neuromuscular Electrostimulation Device and Thromboembolism Deterrent Stockings in Post-Operative Patients Recovering From Elective Total Hip Replacement Surgery.,"BACKGROUND
Total hip replacement is recognised as a major risk factor for deep vein thrombosis (DVT). The aim of this study was to investigate the feasibility of using a novel neuromuscular electrical stimulation device (NMES) for DVT prevention in patients recovering from elective hip replacement surgery.
METHODS
Twenty-eight patients undergoing total hip replacement were randomised to receive postoperative treatment with either the NMES device or compression stockings continually from post-surgery until discharge (day 4). The primary outcome measure was the presence of symptomatic or asymptomatic DVT at 48 hours post-surgery and on the day of discharge from hip replacement surgery, as assessed by Duplex ultrasound. Secondary outcomes included hemodynamic responses to the devices, lower limb oedema, sit-to-stand and timed-up-and-go (TUG) scores, and hip range of motion.
RESULTS
In the compression stockings group, two cases of asymptomatic DVT were identified by Duplex ultrasound at 48 hours post-surgery. No cases were found in the NMES group. Patients in the NMES group demonstrated a general trend of a decrease in leg volume from post-surgery to discharge, whereas leg volume largely remained static for the compression stockings group. In addition, positive hemodynamic effects were found in favour of the NMES group in the non-operated leg. The change in TUG scores also favoured the NMES group (NMES: 150 ± 152%, compression stockings: 363 ± 257% (p=0.03)), whereas no differences in sit-to-stand scores or hip range of motion were observed.
CONCLUSIONS
This study supports the feasibility of NMES as an alternative mechanical prophylaxis worn in the postoperative phase until discharge and provides important findings for clinicians considering novel mechanical prophylaxis options.",2020,"Patients in the NMES group demonstrated a general trend of a decrease in leg volume from post-surgery to discharge, whereas leg volume largely remained static for the compression stockings group.","['Twenty-eight patients undergoing total hip replacement', 'patients recovering from elective hip replacement surgery', 'Post-Operative Patients Recovering From Elective Total Hip Replacement Surgery']","['NMES device or compression stockings', 'compression stockings', 'Neuromuscular Electrostimulation Device and Thromboembolism Deterrent Stockings', 'novel neuromuscular electrical stimulation device (NMES', 'NMES']","['hemodynamic responses to the devices, lower limb oedema, sit-to-stand and timed-up-and-go (TUG) scores, and hip range of motion', 'leg volume', 'asymptomatic DVT', 'presence of symptomatic or asymptomatic DVT', 'sit-to-stand scores or hip range of motion', 'positive hemodynamic effects', 'TUG scores']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0239340', 'cui_str': 'Edema of lower extremity'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",28.0,0.0724381,"Patients in the NMES group demonstrated a general trend of a decrease in leg volume from post-surgery to discharge, whereas leg volume largely remained static for the compression stockings group.","[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Wainwright', 'Affiliation': 'Orthopaedic Research Institute, Bournemouth, UK.'}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Burgess', 'Affiliation': 'Orthopaedic Research Institute, Bournemouth, UK.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Middleton', 'Affiliation': 'Orthopaedic Research Institute, Bournemouth, UK.'}]",Surgical technology international,[]
532,32135126,"Mifepristone pretreatment followed by misoprostol 200 mcg buccal for the medical management of intrauterine fetal death at 14-28 weeks: A randomized, placebo-controlled, double blind trial.","OBJECTIVE
To evaluate whether fetal and placental expulsion is more likely within 48 h if women receive mifepristone pre-treatment vs placebo pre-treatment followed by misoprostol 200 mcg buccally for treatment of fetal death at 14 weeks 0 days to 28 weeks and 6 days gestation.
STUDY DESIGN
We randomized 176 women with a confirmed fetal death between 14 weeks and 0 days to 28 weeks and 6 days to mifepristone 200 mg or placebo; 24 h later all participants received misoprostol 200 mcg buccally every 3 h for up to 16 doses or 48 h. The trial took place in Hanoi, Vietnam and Mexico City in 2015-2018.
RESULTS
Complete expulsion of the fetus and placenta within 48 h of misoprostol administration occurred in 74 of 90 women (82.2%, 95% confidence interval (CI), 72.7%-89.5%) in the mifepristone-misoprostol group and in 70 of 86 women (81.4%, 95% CI, 71.6%-89.0%) in the placebo-misoprostol group (Relative Risk (RR) 1.01, 95%CI 0.87-1.16, p = 0.887). The median time from the start of the misoprostol induction to fetal expulsion was shorter among women who received mifepristone-misoprostol compared to women assigned to placebo-misoprostol (7 h vs ±5 vs 12 ± 13 h; p < 0.001). Women in the mifepristone-misoprostol group were more likely to expel the fetus within 24 h of the start of misoprostol administration (96% vs 78%; RR 1.22 (1.09-1.39) p = 0.009).
CONCLUSION(S)
Mifepristone-misoprostol did not result in a higher rate of complete expulsion of the fetus and the placenta within 48 h of the start of misoprostol administration without any additional surgical intervention or medication (e.g. additional misoprostol doses or oxytocin) than placebo-misoprostol. However, treatment with mifepristone-misoprostol did result in a shorter time to expulsion than placebo misoprostol.
IMPLICATIONS
Pretreatment with mifepristone followed by misoprostol bucally resulted in a shorter treatment time for medical management of fetal death than treatment with misoprostol alone. Pre-treatment with mifepristone may be more acceptable to women and providers by both reducing the length of hospital stay and the amount of misoprostol required.",2020,"Women in the mifepristone-misoprostol group were more likely to expel the fetus within 24 hours of the start of misoprostol administration (96% versus 78%; RR 1.22 (1.09-1.39) p=0.009).
",['176 women with a confirmed fetal death between 14 weeks and 0 days to 28 weeks and 6 days to'],"['misoprostol doses or oxytocin', 'mifepristone 200 mg or placebo', 'mifepristone pre-treatment versus placebo', 'placebo-misoprostol', 'mifepristone-misoprostol', 'Misoprostol 200mcg Buccal', 'placebo misoprostol', 'Mifepristone', 'Mifepristone-misoprostol', 'mifepristone- misoprostol', 'misoprostol', 'Placebo']","['fetal death', 'rate of complete expulsion of the fetus and the placenta', 'fetal expulsion', 'shorter time to expulsion', 'Complete expulsion of the fetus and placenta', 'median time']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1592637', 'cui_str': 'Mifepristone 200 MG [Mifeprex]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}]","[{'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",176.0,0.709479,"Women in the mifepristone-misoprostol group were more likely to expel the fetus within 24 hours of the start of misoprostol administration (96% versus 78%; RR 1.22 (1.09-1.39) p=0.009).
","[{'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Bracken', 'Affiliation': 'Gynuity Health Projects, 220 East 42(nd) Street, Suite #710, New York, NY 10017, United States. Electronic address: hbracken@gynuity.org.'}, {'ForeName': 'Nguyen Thi Nhu', 'Initials': 'NTN', 'LastName': 'Ngoc', 'Affiliation': 'Center for Research and Consultancy in Reproductive Health (CRCRH), 16 D Luy Ban Bich, Tan Thoi Hoa - Tan Phu, Hochiminh City, Viet Nam.'}, {'ForeName': 'Do Quan', 'Initials': 'DQ', 'LastName': 'Ha', 'Affiliation': 'Dept. of Scientific Research and Technology Development, National Obstetrics and Gynecology Hospital, 43, Trang Thi, Hoan Kiem District, Hanoi, Viet Nam.'}, {'ForeName': 'Norberto Reyes', 'Initials': 'NR', 'LastName': 'Paredes', 'Affiliation': 'National Institute of Perinatology (INPer), Montes Urales # 800, Lomas - Virreyes, Lomas de Chapultepec IV Secc, 11000 Mexico City, Mexico. Electronic address: norberto.reyes@inper.gob.mx.'}, {'ForeName': 'Vu Ba', 'Initials': 'VB', 'LastName': 'Quyet', 'Affiliation': 'National Obstetrics and Gynecology Hospital, 43, Trang Thi. Hoan Kiem District, Hanoi, Viet Nam.'}, {'ForeName': 'Nguyen Thi Huyen', 'Initials': 'NTH', 'LastName': 'Linh', 'Affiliation': 'National Obstetrics and Gynecology Hospital, 43, Trang Thi. Hoan Kiem District, Hanoi, Viet Nam.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Ortiz', 'Affiliation': 'National Institute of Perinatology (INPer), Montes Urales # 800, Lomas - Virreyes, Lomas de Chapultepec IV Secc, 11000 Mexico City, Mexico. Electronic address: marco.ortiz@inper.gob.mx.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Bousieguez', 'Affiliation': 'Gynuity Health Projects, 220 East 42(nd) Street, Suite #710, New York, NY 10017, United States. Electronic address: mbousieguez@gynuity.org.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Winikoff', 'Affiliation': 'Gynuity Health Projects, 220 East 42(nd) Street, Suite #710, New York, NY 10017, United States.'}]",Contraception,['10.1016/j.contraception.2020.02.007']
533,32139287,[Cardiovascular risk profile and hypertension in HIV-infected subjects assigned to a health centre: a touch of care].,,2020,,['HIV-infected subjects assigned to a health centre'],[],['Cardiovascular risk profile and hypertension'],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]",[],"[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.0173069,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Albaladejo Blanco', 'Affiliation': 'Centro de Atención Primaria Llefià, Institut Català de la Salut, Badalona, Barcelona, España. Electronic address: carlesalbaladejo@gmail.com.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Canadell Marcos', 'Affiliation': 'Centro de Atención Primaria Llefià, Institut Català de la Salut, Badalona, Barcelona, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bellvert Ríos', 'Affiliation': 'Centro de Atención Primaria Llefià, Institut Català de la Salut, Badalona, Barcelona, España.'}]",Hipertension y riesgo vascular,['10.1016/j.hipert.2020.01.002']
534,32246743,Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation.,"BACKGROUND
Recently, the randomized EINSTEIN-Jr study showed similar efficacy and safety for rivaroxaban and standard anticoagulation for treatment of pediatric venous thromboembolism (VTE). The rivaroxaban dosing strategy was established based on phase 1 and 2 data in children and through pharmacokinetic (PK) modeling.
METHODS
Rivaroxaban treatment with tablets or the newly developed granules-for-oral suspension formulation was bodyweight-adjusted and administered once-daily, twice-daily, or thrice-daily for children with bodyweights of ≥30, ≥12 to <30, and <12 kg, respectively. Previously, these regimens were confirmed for children weighing ≥20 kg but only predicted in those <20 kg. Based on sparse blood sampling, the daily area under the plasma concentration-time curve [AUC (0-24)ss ] and trough [C trough,ss ] and maximum [C max,ss ] steady-state plasma concentrations were derived using population PK modeling. Exposure-response graphs were generated to evaluate the potential relationship of individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events. A taste-and-texture questionnaire was collected for suspension-recipients.
RESULTS
Of the 335 children (aged 0-17 years) allocated to rivaroxaban, 316 (94.3%) were evaluable for PK analyses. Rivaroxaban exposures were within the adult exposure range. No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes. Results were similar for the tablet and suspension formulation. Acceptability and palatability of the suspension were favorable.
DISCUSSION
Based on this analysis and the recently documented similar efficacy and safety of rivaroxaban compared with standard anticoagulation, we conclude that bodyweight-adjusted pediatric rivaroxaban regimens with either tablets or suspension are validated and provide for appropriate treatment of children with VTE.",2020,"No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes.","['pediatric venous thromboembolism', 'children with VTE', 'pediatric venous thromboembolism (VTE', '335 children (aged 0-17 years) allocated to']","['Rivaroxaban', 'rivaroxaban']","['Acceptability and palatability', 'individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events', 'plasma concentration-time curve [AUC (0-24)ss ] and trough [C trough,ss ] and maximum [C max,ss ] steady-state plasma concentrations', 'PK parameters with efficacy, bleeding, or adverse event outcomes']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",335.0,0.0324861,"No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes.","[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': ""Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.""}, {'ForeName': 'Anthonie W A', 'Initials': 'AWA', 'LastName': 'Lensing', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monagle', 'Affiliation': ""Department of Clinical Haematology, Royal Children's Hospital, Haematology Research Murdoch Children's Research Institute, Parkville, Vic., Australia.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Male', 'Affiliation': 'Department of Paediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Thelen', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Palumbo', 'Affiliation': ""Cancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Riten', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ""Nationwide Children's Hospital, The Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Ildar', 'Initials': 'I', 'LastName': 'Nurmeev', 'Affiliation': 'Kazan State Medical University, Kazan, Russia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hege', 'Affiliation': 'Riley Hospital For Children at IU Health, Indianapolis, IN, USA.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Bajolle', 'Affiliation': 'M3C-Necker Enfants malades, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Connor', 'Affiliation': ""The Noah's Ark Children's Hospital for Wales, Cardiff, UK.""}, {'ForeName': 'Hélène L', 'Initials': 'HL', 'LastName': 'Hooimeijer', 'Affiliation': ""Department of Hematology and Oncology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': ""Department of Hematology and Oncology, Cook Children's Medical Center, Fort Worth, TX, USA.""}, {'ForeName': 'Anthony K C', 'Initials': 'AKC', 'LastName': 'Chan', 'Affiliation': ""McMaster Children's Hospital, Hamilton, ON, Canada.""}, {'ForeName': 'Gili', 'Initials': 'G', 'LastName': 'Kenet', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Holzhauer', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Santamaría', 'Affiliation': ""Hemostasis and Thrombosis Unit, Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Amedro', 'Affiliation': 'Paediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Montpellier University Hospital, PhyMedExp, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beyer-Westendorf', 'Affiliation': 'Division of Haematology and Haemostaseology, Department of Medicine I, Department of Haematology, University Hospital ""Carl Gustav Carus"" Dresden, King\'s Thrombosis Service, King\'s College London, London, UK.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Martinelli', 'Affiliation': ""A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'M Patricia', 'Initials': 'MP', 'LastName': 'Massicotte', 'Affiliation': 'Department of Paediatrics, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Smith', 'Affiliation': 'Bayer U.S., LLC, Whippany, NJ, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Whippany, NJ, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, OR, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Price', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, Dalhousie University, IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Prins', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Kubitza', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14813']
535,32184197,A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP).,"Lung cancer screening with low-dose computed tomography (LDCT) reduces lung cancer mortality, yet few eligible high-risk patients receive it annually. This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways. This study uses a stepped-wedge implementation design. Screening centers are randomized by readiness level to enter the intervention phase in three-month ""steps"" with pre-intervention data serving as the control. The primary outcome is whether delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings. Six participating centers will identify 10 practices and reach 2-3 providers per practice to train them to use the Toolkit. The Toolkit will address known barriers to screening and referral at the patient and provider levels and provide support for required elements of screening. Toolkit components include adaptable evidence-based interventions to maximize compatibility with workflows. We hypothesize that after nine months of intervention delivery, the number of initial screening per center will double. Involving 60 practices achieves 80% power at 5% level of significance. Implementation outcomes such as adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs. LDCT for lung cancer screening currently reaches a small fraction of eligible adults. To reach the full potential to reduce mortality, primary care practices are an important venue for increasing appropriate referrals. This multidisciplinary trial will encourage acceptability and sustainability by using local knowledge and promoting partnership between providers and patients. Trial registration: ClinicalTrials.gov, NCT03958253.",2020,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,[],"['LDCT', 'Lung cancer screening with low-dose computed tomography (LDCT', 'community-partnered intervention (Toolkit) designed to support primary care practices', 'community intervention']","['adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs', 'delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings', 'lung cancer mortality']",[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.158435,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,"[{'ForeName': 'Ana S', 'Initials': 'AS', 'LastName': 'Salazar', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: a.salaza@wustl.edu.'}, {'ForeName': 'Subhjit', 'Initials': 'S', 'LastName': 'Sekhon', 'Affiliation': 'University of Missouri-Kansas City, USA. Electronic address: sks3t4@mail.umkc.edu.'}, {'ForeName': 'Karthik W', 'Initials': 'KW', 'LastName': 'Rohatgi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: karthik.rohatgi@wustl.edu.'}, {'ForeName': 'Akua', 'Initials': 'A', 'LastName': 'Nuako', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aanuako@wustl.edu.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: esther@wustl.edu.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Harriss', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: courtney.harriss@wustl.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: ellen.brennan@bjc.org.'}, {'ForeName': 'Dareld', 'Initials': 'D', 'LastName': 'LaBeau', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: dareld.labeau@bjc.org.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdalla', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: ibrahim.abdalla@coxhealth.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Schulze', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: chris.schulze@coxhealth.com.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Muenks', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: jackie.muenks@coxhealth.com.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Overlot', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: daveo@dmhhs.org.'}, {'ForeName': 'Jeri Ann', 'Initials': 'JA', 'LastName': 'Higgins', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: jerih@dmhhs.org.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Jones', 'Affiliation': 'Regional Cancer Center, Memorial Health System, 701 N 1(st), Springfield, IL 62781, USA. Electronic address: jones.linda@mhsil.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Swick', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: cswick@sblhs.org.'}, {'ForeName': 'Stacia', 'Initials': 'S', 'LastName': 'Goings', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: sgoings@sblhs.org.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Badiu', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: jennifer.badiu@sih.net.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: Justin.Walker@sih.net.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: colditzg@wustl.edu.'}, {'ForeName': 'Aimee S', 'Initials': 'AS', 'LastName': 'James', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aimeejames@wustl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105991']
536,32184198,The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans.,"Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD). This paper describes the rationale for and methods of a randomized controlled trial comparing the efficacy and efficiency of written exposure therapy versus imaginal exposure for PTSD delivered in a novel online and variable length format. Participants will be 300 Veterans seeking treatment for clinically significant symptoms of PTSD. Participants will be randomly assigned to either written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists. Treatment is terminated before session 8 if the PTSD symptom improvement criterion is met. Assessments will be conducted at baseline, post-treatment, and at 3-month follow-up. The primary hypotheses are that written exposure therapy will be noninferior to imaginal exposure with respect to treatment efficacy and efficiency. Secondary hypotheses relate to identifying and comparing potential mediators of PTSD treatment outcome, including trauma-related cognitions and emotion regulation.",2020,Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD).,"['posttraumatic stress disorder', 'Veterans with posttraumatic stress disorder (PTSD', '300 Veterans seeking treatment for clinically significant symptoms of PTSD', 'Veterans']","['written exposure therapy versus imaginal exposure for PTSD', 'written exposure therapy versus imaginal exposure delivered online', 'written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists']",['trauma-related cognitions and emotion regulation'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",300.0,0.026439,Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD).,"[{'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA; Stanford University, Department of Psychiatry and Behavioral Sciences, School of Medicine, 401 Quarry Road, Stanford, CA 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Miller', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gengler', 'Affiliation': 'Prevail Health Solutions, LLC, 105 W Chicago Ave #203, Chicago, IL 60642, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Prevail Health Solutions, LLC, 105 W Chicago Ave #203, Chicago, IL 60642, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sloan', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA 02130, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105990']
537,30967424,"Low-Dose Anti-Thymocyte Globulin Preserves C-Peptide, Reduces HbA 1c , and Increases Regulatory to Conventional T-Cell Ratios in New-Onset Type 1 Diabetes: Two-Year Clinical Trial Data.","A three-arm, randomized, double-masked, placebo-controlled phase 2b trial performed by the Type 1 Diabetes TrialNet Study Group previously demonstrated that low-dose anti-thymocyte globulin (ATG) (2.5 mg/kg) preserved β-cell function and reduced HbA 1c for 1 year in new-onset type 1 diabetes. Subjects ( N = 89) were randomized to 1 ) ATG and pegylated granulocyte colony-stimulating factor (GCSF), 2 ) ATG alone, or 3 ) placebo. Herein, we report 2-year area under the curve (AUC) C-peptide and HbA 1c , prespecified secondary end points, and potential immunologic correlates. The 2-year mean mixed-meal tolerance test-stimulated AUC C-peptide, analyzed by ANCOVA adjusting for baseline C-peptide, age, and sex ( n = 82) with significance defined as one-sided P < 0.025, was significantly higher in subjects treated with ATG versus placebo ( P = 0.00005) but not ATG/GCSF versus placebo ( P = 0.032). HbA 1c was significantly reduced at 2 years in subjects treated with ATG ( P = 0.011) and ATG/GCSF ( P = 0.022) versus placebo. Flow cytometry analyses demonstrated reduced circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1 + CD4 + T cells following low-dose ATG and ATG/GCSF. Low-dose ATG partially preserved β-cell function and reduced HbA 1c 2 years after therapy in new-onset type 1 diabetes. Future studies should determine whether low-dose ATG might prevent or delay the onset of type 1 diabetes.",2019,"Flow cytometry analyses demonstrated reduced circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1 + CD4 + T cells following low-dose ATG and ATG/GCSF.","['New-Onset Type 1 Diabetes', 'Subjects ( N = 89) were randomized to 1 ']","['ATG and pegylated granulocyte colony-stimulating factor (GCSF), 2 ', 'placebo', 'Low-Dose Anti-Thymocyte Globulin', 'low-dose anti-thymocyte globulin (ATG) (2.5 mg/kg) preserved β-cell function and reduced HbA 1c', 'ATG versus placebo']","['2-year mean mixed-meal tolerance test-stimulated AUC C-peptide', 'β-cell function', 'HbA 1c', 'circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1 + CD4 + T cells']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",89.0,0.279078,"Flow cytometry analyses demonstrated reduced circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1 + CD4 + T cells following low-dose ATG and ATG/GCSF.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Haller', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL hallemj@peds.ufl.edu.'}, {'ForeName': 'S Alice', 'Initials': 'SA', 'LastName': 'Long', 'Affiliation': 'Benaroya Research Institute, Seattle, WA.'}, {'ForeName': 'J Lori', 'Initials': 'JL', 'LastName': 'Blanchfield', 'Affiliation': 'Benaroya Research Institute, Seattle, WA.'}, {'ForeName': 'Desmond A', 'Initials': 'DA', 'LastName': 'Schatz', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Skyler', 'Affiliation': 'Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Bundy', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Geyer', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Megan V', 'Initials': 'MV', 'LastName': 'Warnock', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Miller', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Atkinson', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL.'}, {'ForeName': 'Dorothy J', 'Initials': 'DJ', 'LastName': 'Becker', 'Affiliation': 'Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Baidal', 'Affiliation': 'Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'DiMeglio', 'Affiliation': 'Indiana University, Indianapolis, IN.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gitelman', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Gottlieb', 'Affiliation': 'University of Colorado Barbara Davis Center for Childhood Diabetes, Aurora, CO.'}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Marks', 'Affiliation': 'Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Moran', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rodriguez', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Russell', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Darrell M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Greenbaum', 'Affiliation': 'Benaroya Research Institute, Seattle, WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0057']
538,31373271,Oral versus intravenous antibiotics for bone and joint infections: the OVIVA non-inferiority RCT.,"BACKGROUND
Management of bone and joint infection commonly includes 4-6 weeks of intravenous (IV) antibiotics, but there is little evidence to suggest that oral (PO) therapy results in worse outcomes.
OBJECTIVE
To determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating bone and joint infection.
DESIGN
Parallel-group, randomised (1 : 1), open-label, non-inferiority trial. The non-inferiority margin was 7.5%.
SETTING
Twenty-six NHS hospitals.
PARTICIPANTS
Adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤ 7 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively).
INTERVENTIONS
Participants were centrally computer-randomised to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy was permitted in either arm.
MAIN OUTCOME MEASURE
The primary outcome was the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation assessed health resource use and quality-of-life data.
RESULTS
Out of 1054 participants (527 in each arm), end-point data were available for 1015 (96.30%) participants. Treatment failure was identified in 141 out of 1015 (13.89%) participants: 74 out of 506 (14.62%) and 67 out of 509 (13.16%) of those participants randomised to IV and PO therapy, respectively. In the intention-to-treat analysis, using multiple imputation to include all participants, the imputed risk difference between PO and IV therapy for definitive treatment failure was -1.38% (90% confidence interval -4.94% to 2.19%), thus meeting the non-inferiority criterion. A complete-case analysis, a per-protocol analysis and sensitivity analyses for missing data each confirmed this result. With the exception of IV catheter complications [49/523 (9.37%) in the IV arm vs. 5/523 (0.96%) in the PO arm)], there was no significant difference between the two arms in the incidence of serious adverse events. PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial.
LIMITATIONS
The OVIVA (Oral Versus IntraVenous Antibiotics) trial was an open-label trial, but bias was limited by assessing all potential end points by a blinded adjudication committee. The population was heterogenous, which facilitated generalisability but limited the statistical power of subgroup analyses. Participants were only followed up for 1 year so differences in late recurrence cannot be excluded.
CONCLUSIONS
PO antibiotic therapy is non-inferior to IV therapy when used during the first 6 weeks in the treatment for bone and joint infection, as assessed by definitive treatment failure within 1 year of randomisation. These findings challenge the current standard of care and provide an opportunity to realise significant benefits for patients, antimicrobial stewardship and the health economy.
FUTURE WORK
Further work is required to define the optimal total duration of therapy for bone and joint infection in the context of specific surgical interventions. Currently, wide variation in clinical practice suggests significant redundancy that likely contributes to the excess and unnecessary use of antibiotics.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN91566927.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 38. See the NIHR Journals Library website for further project information.",2019,"PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial.
","['Twenty-six NHS hospitals', '1054 participants (527 in each arm', 'Adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤\u20097 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively']","['Oral versus intravenous antibiotics', 'PO antibiotic therapy', 'OVIVA (Oral Versus IntraVenous Antibiotics']","['incidence of serious adverse events', 'cost-effectiveness evaluation assessed health resource use and quality-of-life data', 'quality-adjusted life-years', 'proportion of participants experiencing treatment failure within 1 year', 'Treatment failure']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0162643'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1054.0,0.198083,"PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Scarborough', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Ho Kwong', 'Initials': 'HK', 'LastName': 'Li', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Rombach', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rhea', 'Initials': 'R', 'LastName': 'Zambellas', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'McNally', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Atkins', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kümin', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Lipsky', 'Affiliation': 'Green Templeton College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hughes', 'Affiliation': 'Department of Microbiology and Public Health, University Hospital of Wales, Public Health Wales, Cardiff, Wales.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Bose', 'Affiliation': 'Department of Orthopaedic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Warren', 'Affiliation': 'Infectious Diseases and Microbiology, Royal National Orthopaedic Hospital NHS Trust, Stanmore, UK.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Mack', 'Affiliation': 'Infectious Diseases and Microbiology, Royal National Orthopaedic Hospital NHS Trust, Stanmore, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Folb', 'Affiliation': 'Department of Microbiology, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Moore', 'Affiliation': 'Infectious Diseases and Microbiology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jenkins', 'Affiliation': 'Infectious Diseases, Heart of England NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': 'Infectious Diseases and Microbiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Seaton', 'Affiliation': 'Infectious Diseases and Microbiology, Gartnaval General Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hemsley', 'Affiliation': ""Department of Microbiology and Infectious Diseases, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sandoe', 'Affiliation': 'Department of Microbiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Ila', 'Initials': 'I', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': 'Infectious Diseases, Northumbria Healthcare NHS Foundation Trust, Cramlington, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Infectious Diseases Unit, Regional Infectious Diseases Unit, Western General Hospital, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Geue', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McMeekin', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Scarborough', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'National Infection Service, Public Health England, Horsham, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Cooke', 'Affiliation': 'Division of Infectious Diseases, Imperial College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bostock', 'Affiliation': ""Patient and Public Representative, Division of Health and Social Care Research, King's College London, , London, UK.""}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khatamzas', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Wong', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brent', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lomas', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Matthews', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Gundle', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Bejon', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23380']
539,31789541,Iwankapiya American Indian pilot clinical trial: Historical trauma and group interpersonal psychotherapy.,"American Indians face pervasive trauma exposure, collective histories of communal suffering, and elevated risk for depression and posttraumatic stress disorder. In addition to socioeconomic barriers, access to culturally responsive treatment is limited, which may compromise treatment engagement. The Iwankapiya study piloted the Historical Trauma and Unresolved Grief Intervention (HTUG), combined with Group Interpersonal Psychotherapy (IPT), to reduce symptoms of depression and related trauma and grief. The study hypothesized that HTUG + IPT would lead to greater group engagement and decreased depression and related symptoms compared with IPT-Only. American Indian adults ( n = 52) were randomized into one of two 12-session interventions, HTUG + IPT or IPT-Only, at two tribal sites: one Northern Plains reservation ( n = 26) and one Southwest urban clinic ( n = 26). Standardized measures assessed depression, posttraumatic stress disorder, grief, trauma, and substance use. Data were collected at screening, baseline, end of intervention, and 8 weeks postintervention; depression and group engagement measures were also collected at Weeks 4 and 8 of the intervention. Depression scores significantly decreased for both treatments, but there were no significant differences in depression between the two groups: IPT-Only (30.2 ± 6.4 at baseline to 16.7 ± 12.1 at follow-up) and HTUG + IPT (30.2 ± 8.1 at baseline to 19.9 ± 8.8 at follow-up). However, HTUG + IPT participants demonstrated significantly greater group engagement. Postintervention, clinicians expressed preference for HTUG + IPT based upon qualitative observations of greater perceived gains among participants. Given the degree of trauma exposure in tribal communities, these findings in a relatively small sample suggest HTUG should be further examined in context of treatment engagement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Depression scores significantly decreased for both treatments, but there were no significant differences in depression between the two groups: IPT-Only (30.2 ± 6.4 at baseline to 16.7 ± 12.1 at follow-up) and HTUG + IPT (30.2 ± 8.1 at baseline to 19.9 ± 8.8 at follow-up).",['American Indian adults ( n = 52'],"['HTUG + IPT or IPT', 'HTUG + IPT', 'Historical Trauma and Unresolved Grief Intervention (HTUG), combined with Group Interpersonal Psychotherapy (IPT']","['depression, posttraumatic stress disorder, grief, trauma, and substance use', 'depression', 'Depression scores']","[{'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0443342', 'cui_str': 'Unresolved (qualifier value)'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",2019.0,0.0347707,"Depression scores significantly decreased for both treatments, but there were no significant differences in depression between the two groups: IPT-Only (30.2 ± 6.4 at baseline to 16.7 ± 12.1 at follow-up) and HTUG + IPT (30.2 ± 8.1 at baseline to 19.9 ± 8.8 at follow-up).","[{'ForeName': 'Maria Yellow Horse', 'Initials': 'MYH', 'LastName': 'Brave Heart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Chase', 'Affiliation': 'Department of Social Work, Oglala Lakota College.'}, {'ForeName': 'Orrin', 'Initials': 'O', 'LastName': 'Myers', 'Affiliation': 'Department of Family and Community Medicine, University of New Mexico.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Elkins', 'Affiliation': 'School of Social Work, University of Georgia.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Skipper', 'Affiliation': 'Department of Family and Community Medicine, University of New Mexico.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Schmitt', 'Affiliation': 'Department of Family and Community Medicine, University of New Mexico.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mootz', 'Affiliation': 'New York State Psychiatric Institute, Columbia University.'}, {'ForeName': 'V Ann', 'Initials': 'VA', 'LastName': 'Waldorf', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000267']
540,32242241,Comment on Li et al.: Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study.,,2020,,['high tibial osteotomy'],[' Drainage relieves pain without increasing post-operative blood loss'],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",[],,0.0521105,,"[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'The Third Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China. helloyh2008@126.com.'}]",International orthopaedics,['10.1007/s00264-020-04555-4']
541,32166831,Pharmacokinetics of an intravenous bolus dose of clonidine in children undergoing surgery.,"BACKGROUND
Clonidine is used off-label in children but only limited pediatric pharmacokinetic data are available for intravenously administered clonidine.
OBJECTIVES
To determine pharmacokinetic parameter estimates of clonidine in healthy children undergoing surgery and to investigate age-related differences. Furthermore, to investigate possible pharmacokinetic differences of clonidine between this group of children and a cohort with cardiac diseases.
METHODS
In a randomized placebo-controlled trial (The PREVENT AGITATION trial), blood samples for clonidine pharmacokinetic analysis were collected in a proportion of the enrolled patients. Healthy children with ASA score 1-2 in the age-groups 1 to <2 years and 2-5 years were randomized for blood sampling. Clonidine was administered as a single intravenous bolus of 3 µg/kg intraoperatively. Blood samples were drawn at baseline, 5, 10, 15, 30, 60 minutes after dosing and additionally every hour until discharge from the PACU. Clonidine analysis was performed on liquid chromatography-mass spectrometry.
RESULTS
Data form eighteen children were available for pharmacokinetic analysis (ASA I; male/female: 17/1; age: 1-5 years; weight 8.7-24 kg). Population parameter estimates for the 2-compartment model were similar to previous published data for children who underwent cardiac surgery. A pooled analysis including data from 59 children indicated clearance of 14.4 L h -1 70 kg -1 and volume of distribution of 192.6 L 70 kg -1 . No age-related pharmacokinetic differences and no difference in time from administration of study medication to awakening were found. Children 1 to <2 years had a shorter PACU stay than children 2-5 years (mean difference 17% 95% CI:3%-34%, P = .02).
CONCLUSION
Pharmacokinetic parameter estimates were similar for children undergoing general surgery and cardiac surgery given a single dose of intravenous clonidine. These results indicated that no dose reduction is needed in children aged 1 to <2 years compared with those 2-5 years, which was supported by pharmacodynamic observations.",2020,"Children 1 to <2 years had a shorter PACU stay than children 2 to 5 years (mean difference 17% 95% CI:3-34%, p=0.02).
","['children who underwent cardiac surgery', 'children and a cohort with cardiac diseases', 'proportion of the enrolled patients', 'children undergoing general surgery and cardiac surgery', 'eighteen children were available for pharmacokinetic analysis (ASA I; male/female: 17/1; age: 1 to 5 years; weight 8.7-24 kg', 'children undergoing surgery', '59 children indicated clearance of 14.4 L.h -1 .70kg -1 and volume of distribution of 192.6 L.70 kg -1 ', 'healthy children undergoing surgery and to investigate age-related differences', 'Healthy children with ASA score 1-2 in the age-groups 1 to <2 years and 2 to 5 years']","['Clonidine', 'placebo', 'clonidine']",['shorter PACU stay'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}]",18.0,0.418842,"Children 1 to <2 years had a shorter PACU stay than children 2 to 5 years (mean difference 17% 95% CI:3-34%, p=0.02).
","[{'ForeName': 'Bettina N', 'Initials': 'BN', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Anaesthesiology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Falcon', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Steen W', 'Initials': 'SW', 'LastName': 'Henneberg', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Lauritsen', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lomstein', 'Affiliation': 'Center for Laboratory, Food and Environmental Technology, The Business Academy Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Ydemann', 'Affiliation': 'Department of Neuroanaethestesiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Afshari', 'Affiliation': 'Department of Anaesthesia, The Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",Paediatric anaesthesia,['10.1111/pan.13856']
542,32245746,Dapagliflozin Versus Placebo on Left Ventricular Remodeling in Patients With Diabetes and Heart Failure: The REFORM Trial.,"OBJECTIVE
To determine the effects of dapagliflozin in patients with heart failure (HF) and type 2 diabetes mellitus (T2DM) on left ventricular (LV) remodeling using cardiac MRI.
RESEARCH DESIGN AND METHODS
We randomized 56 patients with T2DM and HF with LV systolic dysfunction to dapagliflozin 10 mg daily or placebo for 1 year, on top of usual therapy. The primary end point was difference in LV end-systolic volume (LVESV) using cardiac MRI. Key secondary end points included other measures of LV remodeling and clinical and biochemical parameters.
RESULTS
In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling. However, it reduced diastolic blood pressure and loop diuretic requirements while increasing hemoglobin, hematocrit, and ketone bodies. There was a trend toward lower weight.
CONCLUSIONS
We were unable to determine with certainty whether dapagliflozin in patients with T2DM and HF had any effect on LV remodeling. Whether the benefits of dapagliflozin in HF are due to remodeling or other mechanisms remains unknown.",2020,"In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling.","['56 patients with T2DM and HF with LV systolic dysfunction to', 'patients with heart failure (HF) and type 2 diabetes mellitus (T2DM', 'Patients With Diabetes and Heart Failure']","['dapagliflozin 10 mg daily or placebo', 'Dapagliflozin Versus Placebo', 'dapagliflozin']","['diastolic blood pressure and loop diuretic requirements', 'lower weight', 'Left Ventricular Remodeling', 'LV remodeling', 'hemoglobin, hematocrit, and ketone bodies', 'LV end-systolic volume (LVESV) using cardiac MRI', 'LV remodeling and clinical and biochemical parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0412692', 'cui_str': 'Cardiac MRI'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",56.0,0.196478,"In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling.","[{'ForeName': 'Jagdeep S S', 'Initials': 'JSS', 'LastName': 'Singh', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Ify R', 'Initials': 'IR', 'LastName': 'Mordi', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Keeran', 'Initials': 'K', 'LastName': 'Vickneson', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Mohapradeep', 'Initials': 'M', 'LastName': 'Mohan', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Anna Maria J', 'Initials': 'AMJ', 'LastName': 'Choy', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, NHS Tayside, Dundee, U.K.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Faisel', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'J Graeme', 'Initials': 'JG', 'LastName': 'Houston', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K. c.c.lang@dundee.ac.uk.'}]",Diabetes care,['10.2337/dc19-2187']
543,32087336,Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness.,"BACKGROUND
Cardiovascular (CV) disease is the leading cause of death for people with serious mental illness (SMI), but clinicians are often slow to address this risk.
METHODS/DESIGN
78 Midwestern primary care clinics were randomized to receive or not receive access to a clinical decision support (CDS) tool. Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Psychiatrists received CDS alerts during their next visit with an eligible patient with SMI that alerted them to an elevated body mass index or recent weight gain and the presence of an obesogenic SMI medication. Study outcomes include total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications.
DISCUSSION
This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI. Effectiveness will be assessed using an intent-to-treat analysis, and outcomes will be assessed largely through electronic health record data harvested by the CDS tool itself. In total, 10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit. Analyses are ongoing, and trial results are expected in mid-2020.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02451670.",2020,This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI.,"['patients with SMI', '10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit', 'Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal', 'people with serious mental illness', 'people with serious mental illness (SMI', '78 Midwestern primary care clinics']",['clinical decision support (CDS) tool'],"['CV risk', 'total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications', 'cardiovascular risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",10347.0,0.266181,This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI.,"[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Rossom', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America. Electronic address: rebecca.c.rossom@healthpartners.com.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'A Lauren', 'Initials': 'AL', 'LastName': 'Crain', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Waring', 'Affiliation': 'Essentia Health, Duluth, MN, United States of America.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Ohnsorg', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'Allise', 'Initials': 'A', 'LastName': 'Taran', 'Affiliation': 'Essentia Health, Duluth, MN, United States of America.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Kopski', 'Affiliation': 'HealthPartners Medical Group, Minneapolis, MN, United States of America.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105964']
544,32087338,The impact of financial incentives on utilization and outcomes of diabetes prevention programs among Medicaid managed care adults in New York state.,"Diabetes prevalence has risen rapidly and has become a global health challenge. The Diabetes Prevention Program (DPP) has been shown to prevent or delay the development of diabetes among individuals with prediabetes. Yet, diabetes prevention studies within the Medicaid population are limited and results are mixed. This study aimed to evaluate the impact of different financial incentive strategies on the utilization of the DPP for Medicaid managed care adults in New York State. A four-arm randomized controlled trial was conducted among Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity. Study participants were offered a 16-week DPP with various incentive strategies based on class attendance and weight loss as follows: Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss. A control group was offered DPP with no incentives for attendance or weight loss. We evaluated the impact of incentives on achievement of the program completion and weight-loss milestone. Participants who received incentives for the Attendance-Only class were least likely to be lost to follow-up, more likely to complete the program, and had two times higher percentage of meeting the weight-loss milestone compared to the control group. Results for the other incentive cohorts were mixed. A strong positive association was observed for participants who attended 9 or more classes and weight-loss regardless of incentive strategies. Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone. However, the results from this study indicate that participant enrollment and retention remained challenges despite the incentives.",2020,Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone.,"['Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity', 'individuals with prediabetes', 'Medicaid managed care adults in New York State', 'Medicaid managed care adults in New York state']","['Diabetes Prevention Program (DPP', 'DPP with various incentive strategies based on class attendance and weight loss as follows']","['weight-loss milestone', 'Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss']","[{'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0283401,Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone.,"[{'ForeName': 'Jo-Yu', 'Initials': 'JY', 'LastName': 'Chin', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: Jo-Yu.Chin@health.ny.gov.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Matson', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: jacqueline.matson@health.ny.gov.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McCauley', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: susan.mccauley@health.ny.gov.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Anarella', 'Affiliation': 'Albany, NY, USA. Electronic address: joeanarella@gmail.com.'}, {'ForeName': 'Foster', 'Initials': 'F', 'LastName': 'Gesten', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: fgesten@nycap.rr.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roohan', 'Affiliation': 'MVP Health Care, Schenectady, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105960']
545,32087339,"Treatment for anxiety: Mindfulness meditation versus escitalopram (TAME): Design of a randomized, controlled non-inferiority trial.","Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia) are common, distressing, and impairing. While pharmacotherapy and psychotherapy are first-line treatment strategies for anxiety disorders, many patients are reluctant to take psychiatric medication, and many prefer to avoid any kind of mental health treatment due to stigma or distrust of traditional medical care. We present the trial protocol for the first study comparing first-line medication treatment with Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program, for the treatment of anxiety disorders. We will use a non-inferiority, comparative effectiveness trial design, in which individuals with diagnosed anxiety disorders will be randomized to either pharmacotherapy with escitalopram or MBSR for 8 weeks of treatment. Treatment outcome will be based on gold standard symptom severity measures assessed by trained independent evaluators blind to treatment allocation. Secondary outcomes will include key symptom and function measures, as well as tolerability and satisfaction with treatment. Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.",2020,"Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.","['anxiety disorders', 'individuals with diagnosed anxiety disorders']","['Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program', 'anxiety: Mindfulness meditation versus escitalopram (TAME', 'pharmacotherapy with escitalopram or MBSR']","['Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia', 'key symptom and function measures, as well as tolerability and satisfaction with treatment']","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0150277'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0287433,"Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hoge', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA. Electronic address: eah103@georgetown.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mihriye', 'Initials': 'M', 'LastName': 'Mete', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA; MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Philip', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gabriel', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Meredith J', 'Initials': 'MJ', 'LastName': 'Ward', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Suzuki', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Dutton', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York University School of Medicine, New York, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105965']
546,32032641,Birth Control Connect: A randomized trial of an online group to disseminate contraceptive information.,"OBJECTIVE
We sought to test whether participation in an online group including IUD users influenced IUD-related knowledge, attitudes, and behavior among IUD non-users, as a proof-of-concept evaluation of information dissemination for less commonly used or novel contraceptives.
STUDY DESIGN
We conducted a blinded, randomized controlled trial on the effect of online communication with IUD users within an online program called Birth Control Connect. Participants were women age 18-45 living in the United States who had never used an IUD. We invited participants randomized to the intervention to join two-week, nine-member discussion groups including four satisfied IUD users and five IUD non-users; we invited control participants to groups including nine IUD non-users. We performed chi-squared tests on IUD knowledge, information-seeking, informational support and use in immediate post-surveys, and t-tests comparing change in IUD attitudes and frequency of logins to discussion groups.
RESULTS
We invited 488 IUD non-users and enrolled them into 70 groups between October 2015 and April 2016. We found increased positive attitudes towards the IUD in the intervention arm (0.65-point increase between pre- and post-surveys, versus 0.05 mean change for control arm, p = 0.03 for hormonal IUD, with a trend in the same direction for the non-hormonal IUD). Informational support also increased, with 70.3% of intervention arm participants self-reporting that they gained a better idea of what the IUD would be like, compared to 51.3% in control arm (p < 0.01). Of intervention participants, 63.3% versus 51.3% of control participants reported gaining new information from their group (p = 0.03). There were no differences in correct responses to knowledge items or information-seeking between groups.
CONCLUSIONS
Online exposure to IUD users increased positive attitudes toward the IUD and informational support for decision-making about the IUD among non-users.
IMPLICATIONS STATEMENT
Online spaces provide a promising environment for the exchange of accurate, useful contraceptive information based on real user experiences. Interventions aiming to harness social communication through structured online conversations (e.g., on existing social media platforms) about user experiences with lesser-known contraceptive methods such as the IUD may be worthwhile.",2020,"Of intervention participants, 63.3% versus 51.3% of control participants reported gaining new information from their group (p=0.03).","['Participants were women age 18-45 living in the United States who had never used an IUD', '488 IUD non-users and enrolled them into 70 groups between October 2015 and April 2016']",['nine-member discussion groups including four satisfied IUD users and five IUD non-users; we invited control participants to groups including nine IUD non-users'],"['gaining new information', 'correct responses to knowledge items or information-seeking', 'positive attitudes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205455', 'cui_str': '9'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}]",488.0,0.257525,"Of intervention participants, 63.3% versus 51.3% of control participants reported gaining new information from their group (p=0.03).","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dehlendorf', 'Affiliation': 'University of California, San Francisco, Department of Family & Community Medicine, Person-Centered Reproductive Health Program, 1001 Potrero Ave., San Francisco, CA 94110, USA; University of California, San Francisco, Department of Obstetrics, Gynecology, & Reproductive Sciences, 1001 Potrero Ave., San Francisco, CA 94110, USA; University of California, San Francisco, Department of Epidemiology and Biostatistics, 1001 Potrero Ave., San Francisco, CA 94110, USA. Electronic address: christine.dehlendorf@ucsf.edu.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fox', 'Affiliation': 'University of California, San Francisco, Department of Family & Community Medicine, Person-Centered Reproductive Health Program, 1001 Potrero Ave., San Francisco, CA 94110, USA. Electronic address: edith.fox@ucsf.edu.'}, {'ForeName': 'Anjana E', 'Initials': 'AE', 'LastName': 'Sharma', 'Affiliation': 'University of California, San Francisco, Department of Family & Community Medicine, Person-Centered Reproductive Health Program, 1001 Potrero Ave., San Francisco, CA 94110, USA. Electronic address: anjana.sharma@ucsf.edu.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, Network Dynamics Group, 3620 Walnut Street, Philadelphia, PA 19104, USA; University of California, Davis, Department of Communication, One Shields Avenue, Davis, CA 95616, USA. Electronic address: jwzzhang@ucdavis.edu.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, Network Dynamics Group, 3620 Walnut Street, Philadelphia, PA 19104, USA. Electronic address: sijia.yang@asc.penn.edu.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Centola', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, Network Dynamics Group, 3620 Walnut Street, Philadelphia, PA 19104, USA. Electronic address: dcentola@asc.penn.edu.'}]",Contraception,['10.1016/j.contraception.2020.01.014']
547,32242400,Effect of plum-blossom needling versus tropicamide eye drops on adolescent myopia: protocol for a randomized crossover trial.,"OBJECTIVE
Myopia is the most common eye problem and affects an estimated 28.3% of the global population. Its incidence is increasing annually. Myopia treatment is limited to correcting visual acuity. Acupuncture is one of the main therapies in traditional Chinese medicine and includes plum-blossom needling, which has been widely used for both the prevention and treatment of adolescent myopia. We hypothesized that plum-blossom needling would be effective in treating myopia compared with a tropicamide eye drops control.
METHODS
This is a crossover randomized controlled trial involving adolescents with myopia. Participants will be randomized 1∶1 to plum-blossom needle or tropicamide eye drops arms. Subjects in each arm will be treated for 20 d, followed by a 1-month washout period and treatment change for another 20 d. The primary outcome is uncorrected distance and cycloplegic refractive errors. The secondary outcomes comprise corneal curvature, lens thickness, axial length, ciliary body thickness, accommodation amplitude, the NRA/PRA (negative/positive relative accommodation), flexible adjustment, and near point of convergence. The outcome measures will be assessed at baseline, after the first treatment course (the first month), at the end of the washout period (the second month), after the second treatment course (the third month), and at follow-up (the sixth month).
DISCUSSION
The results of the trial will help to provide evidence for the efficacy of plum-blossom needling for myopia in China.",2020,"The secondary outcomes comprise corneal curvature, lens thickness, axial length, ciliary body thickness, accommodation amplitude, the NRA/PRA (negative/positive relative accommodation), flexible adjustment, and near point of convergence.","['adolescent myopia', 'adolescents with myopia']","['plum-blossom needle or tropicamide', 'Acupuncture', 'plum-blossom needling versus tropicamide eye drops', 'tropicamide', 'plum-blossom needling']","['corneal curvature, lens thickness, axial length, ciliary body thickness, accommodation amplitude, the NRA/PRA (negative/positive relative accommodation), flexible adjustment, and near point of convergence', 'uncorrected distance and cycloplegic refractive errors']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}]","[{'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C1299693', 'cui_str': 'Lens thickness'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0008779', 'cui_str': 'Ciliary body structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0633231', 'cui_str': 'S100A6 protein, human'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0429572', 'cui_str': 'Ocular accommodation near point'}, {'cui': 'C0443193', 'cui_str': 'Convergence'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}]",,0.147703,"The secondary outcomes comprise corneal curvature, lens thickness, axial length, ciliary body thickness, accommodation amplitude, the NRA/PRA (negative/positive relative accommodation), flexible adjustment, and near point of convergence.","[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Physical Medicine and Rehabilitation, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Yuanbo', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Clinical and Epidemiological Research Center, Eye Hospital of Wenzhou Medical University, Wenzhou 325027, China.'}, {'ForeName': 'Meiping', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Amblyopia and Strabismus, Eye Hospital of Wenzhou Medical University, Wenzhou 325027, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Clinical and Epidemiological Research Center, Eye Hospital of Wenzhou Medical University, Wenzhou 325027, China.'}, {'ForeName': 'Huanyun', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Amblyopia and Strabismus, Eye Hospital of Wenzhou Medical University, Wenzhou 325027, China.'}, {'ForeName': 'Lewei', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Physical Medicine and Rehabilitation, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
548,32119926,A comparative effectiveness trial of an information technology enhanced peer-integrated collaborative care intervention versus enhanced usual care for US trauma care systems: Clinical study protocol.,"Annually approximately 2-3 million Americans are so severely injured that they require inpatient hospitalization. The study team, which includes patients, clinical researchers, front-line provider and policy maker stakeholders, has been working together for over a decade to develop interventions that target improvements for US trauma care systems nationally. This pragmatic randomized trial compares a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care. The peer-integrated collaborative care intervention will be supported by a novel emergency department exchange health information technology platform. A total of 424 patients will be randomized to peer-integrated collaborative care (n = 212) and surgical team notification (n = 212) conditions. The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification. These four primary outcomes will be followed-up at 1- 3-, 6-, 9- and 12-months after injury for all patients. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) method will be used to assess implementation processes. Data from the primary outcome analysis and implementation process assessment will be used to inform an end-of-study policy summit with the American College of Surgeons Committee on Trauma. The policy summit will facilitate acute care practice changes related to patient-centered care transitions over the course of a single 5-year funding cycle. Trial registration: (Clinicaltrials.govNCT03569878).",2020,"The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification.","['424 patients will be randomized to peer-integrated collaborative care (n\u202f=\u202f212) and surgical team notification (n\u202f=\u202f212) conditions', 'integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care']","['information technology enhanced peer-integrated collaborative care intervention', 'peer integrated collaborative care intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}]",[],424.0,0.135098,"The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Scheuer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: hscheuer@uw.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Engstrom', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: alliengs@uw.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'Powers Pyles Sutter & Verville PC, 501 M Street, NW, Seventh Floor, Washington, DC 20005, United States of America. Electronic address: Peter.Thomas@PowersLaw.com.'}, {'ForeName': 'Rddhi', 'Initials': 'R', 'LastName': 'Moodliar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: rddhim@uw.edu.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Moloney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: kmoloney@uw.edu.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Walen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: marylouw@uw.edu.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: peej23@uw.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: saraseo@uw.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Vaziri', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: nvaziri@uw.edu.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: alvmarti@uw.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, 410 9th Ave., Seattle, WA 98104, United States of America. Electronic address: ronmaier@uw.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: jerusso@uw.edu.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Sieber', 'Affiliation': 'Molecular Genomics Core/Microarray Group, National Institute of Environmental Health Sciences, P.O. Box 12233, Mail Drop D2-04, Durham, N.C 27709, United States of America. Electronic address: sieber@niehs.nih.gov.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Anziano', 'Affiliation': 'Shepherd Center, 2020 Peachtree Road NW, Atlanta, GA 30309-1465, United States of America. Electronic address: Pete.Anziano@shepherd.org.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America; The Koshka Foundation, United States of America. Electronic address: kanderson@koshkafoundation.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bulger', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, 410 9th Ave., Seattle, WA 98104, United States of America. Electronic address: ebulger@uw.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whiteside', 'Affiliation': 'Department of Emergency Medicine, University of Washington School of Medicine, 325 9th Ave., Seattle, WA 98104, United States of America. Electronic address: laurenkw@uw.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington School of Public Health, 1705 NE Pacific St., Seattle, WA 98195, United States of America. Electronic address: heagerty@uw.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Palinkas', 'Affiliation': 'Department of Children, Youth and Families, USC Suzanne Dworak-Peck School of Social Work, 669 W 34(th) St., Los Angeles, CA 90089, United States of America. Electronic address: palinkas@usc.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Zatzick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: dzatzick@uw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105970']
549,32124514,CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.,"OBJECTIVES
To evaluate the activity of intravesical mitomycin-C (MMC) to ablate recurrent low-risk non-muscle-invasive bladder cancer (NMIBC) and assess whether it may enable patients to avoid surgical intervention for treatment of recurrence.
PATIENTS AND METHODS
CALIBER is a phase II feasibility study. Participants were randomized (2:1) to treatment with four once-weekly MMC 40-mg intravesical instillations (chemoablation arm) or to surgical management. The surgical group was included to assess the feasibility of randomization. The primary endpoint was complete response to intravesical MMC in the chemoablation arm at 3 months, reported with exact 95% confidence intervals (CIs). Secondary endpoints included time to subsequent recurrence, summarized by Kaplan-Meier methods.
RESULTS
Between February 2015 and August 2017, 82 patients with visual diagnosis of recurrent low-risk NMIBC were enrolled from 24 UK hospitals (chemoablation, n = 54; surgical management, n =28). The median follow-up was 24 months. Complete response at 3 months was 37.0% (20/54; 95% CI 24.3-51.3) with chemoablation and 80.8% (21/26; 95% CI 60.6-93.4) with surgical management. Amongst patients with complete response at 3 months, a similar proportion was recurrence-free by 12 months in both groups (84%). Amongst those with residual disease at 3 months, the 12-month recurrence-free proportion was lower in the surgical management group (40.0%) than in the chemoablation group (84%). Recruitment stopped early as chemoablation did not meet the prespecified threshold of 45% complete responses at 3 months.
CONCLUSION
Intravesical chemoablation in low-risk NMIBC is feasible and safe, but did not demonstrate sufficient response in the present trial. After chemoablation there may be a reduction in recurrence rate, even in non-responders, that is greater than with surgery alone. Further research is required to investigate the role and optimal schedule of neoadjuvant intravesical chemotherapy prior to surgery for NMIBC.",2020,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","['Between February 2015 and August 2017', 'low risk non-muscle invasive bladder cancer', '82 patients with visual diagnosis of recurrent low risk NMIBC were enrolled from 24 UK hospitals (54 chemoablation, 28 surgical management']","['intravesical mitomycin C (MMC', 'mitomycin', 'MMC 40mg intravesical instillations (chemoablation arm) or surgical management']","['recurrence rate', 'Complete response', 'time to subsequent recurrence, summarised by Kaplan-Meier methods', '12-month recurrence-free proportion', 'complete response to intravesical MMC', 'recurrence-free']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}]",82.0,0.125464,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","[{'ForeName': 'A Hugh', 'Initials': 'AH', 'LastName': 'Mostafid', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cresswell', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Thomas R L', 'Initials': 'TRL', 'LastName': 'Griffiths', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Kelly', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Penegar', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Davenport', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Campain', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cooke', 'Affiliation': 'Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Shikohe', 'Initials': 'S', 'LastName': 'Masood', 'Affiliation': 'Medway NHS Foundation Trust, Gillingham, UK.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Knowles', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feber', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Action Bladder Cancer UK, Gloucestershire, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Institute of Cancer Research, London, UK.'}]",BJU international,['10.1111/bju.15038']
550,32145440,Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.,"BACKGROUND
Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD.
METHODS
We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 μg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up.
CONCLUSION
GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.",2020,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"['176 patients', 'patients with PAD experience claudication despite adequate medical and/or surgical management', 'patients with lower extremity PAD']","['GM-CSF', 'placebo', 'Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF', 'granulocyte-macrophage colony stimulating factor', 'placebo group receive matching placebo injections', 'placebo injections']",['change in 6-min walk distance between baseline and 6-month follow-up'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.40022,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Rogers', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Devinder S', 'Initials': 'DS', 'LastName': 'Dhindsa', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cydney', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Risha', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Martini', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mahadev', 'Initials': 'M', 'LastName': 'Prasad', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mokhtari', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Iraj G', 'Initials': 'IG', 'LastName': 'Hesaroieh', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Frohwein', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Kutner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Harzand', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Wells', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Duwayri', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Olamide', 'Initials': 'O', 'LastName': 'Alabi', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Rajani', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Brewster', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Winship Cancer Institute, Department of Hematology and Oncology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. Electronic address: Aquyyum@Emory.Edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105975']
551,31914147,"Generalizing findings from a randomized controlled trial to a real-world study of the iLookOut, an online education program to improve early childhood care and education providers' knowledge and attitudes about reporting child maltreatment.","In recent years, real-world studies (RWS) are gaining increasing interests, because they can generate more realistic and generalizable results than randomized controlled clinical trials (RCT). In 2017, we published a RCT in 741 early childhood care and education providers (CCPs). It is the Phase I of our iLookOut for Child Abuse project (iLookOut), an online, interactive learning module about reporting suspected child maltreatment. That study demonstrated that in a RCT setting, the iLookOut is efficient at improving CCPs' knowledge of and attitudes towards child maltreatment reporting. However, the generalizability of that RCT's results in a RWS setting remains unknown. To address this question, we design and conduct this large RWS in 11,065 CCPs, which is the Phase II of the iLookOut. We hypothesize replication of the earlier RCT findings, i.e., the iLookOut can improve CCPs' knowledge of and attitudes toward child maltreatment reporting in a real world setting. In addition, this RWS also explores whether demographic factors affect CCPs' performance. Results of this RWS confirmed the generalizability of the previous RCT's results in a real world setting. It yielded similar effect sizes for knowledge and attitudes as were found in the earlier RCT. Cohen's d for knowledge improvement was 0.95 in that RCT, 0.96 in this RWS; Cohen's d for attitude improvement was 0.98 in that RCT, 0.80 in this RWS. Also, we found several significant differences in knowledge and attitude improvement with regard to age, race, education, and employment status. In conclusion, iLookOut improves knowledge and attitudes of CCPs about child maltreatment prevention and reporting in a real-world setting. The generalizability of the initial RCT findings to this RWS provides strong evidence that the iLookout will be effective in other real world settings. It can be a useful model for other interventions aimed at preventing child maltreatment. Clinical trial registration for the original RCT: NCT02225301 (ClinicalTrials.gov Identifier).",2020,"In conclusion, iLookOut improves knowledge and attitudes of CCPs about child maltreatment prevention and reporting in a real-world setting.",['741 early childhood care and education providers (CCPs'],[],"['knowledge and attitude improvement with regard to age, race, education, and employment status', 'attitude improvement', 'knowledge improvement']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242271', 'cui_str': 'Employment status (observable entity)'}]",741.0,0.0405628,"In conclusion, iLookOut improves knowledge and attitudes of CCPs about child maltreatment prevention and reporting in a real-world setting.","[{'ForeName': 'Chengwu', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Health Promotion, New York University College of Dentistry, New York City, New York, United States of America.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Panlilio', 'Affiliation': 'Department of Educational Psychology, Counseling and Special Education, Pennsylvania State University, University Park, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Verdiglione', 'Affiliation': 'Departments of Humanities, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Lehman', 'Affiliation': 'Departments of Population Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hamm', 'Affiliation': 'Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fiene', 'Affiliation': 'Departments of Psychology & Human Development Research Center, Pennsylvania State University, Middletown, Pennsylvania, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dore', 'Affiliation': 'Departments of Humanities, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Bard', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Grable', 'Affiliation': 'Departments of Psychology & Human Development Research Center, Pennsylvania State University, Middletown, Pennsylvania, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Levi', 'Affiliation': 'Departments of Humanities & Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0227398']
552,32037592,A randomized controlled trial of a physiology-guided percutaneous coronary intervention optimization strategy: Rationale and design of the TARGET FFR study.,"Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis. There are currently limited data available to determine how often it is possible to improve an angiographically acceptable but physiologically suboptimal result. A physiology-guided optimization strategy can achieve a clinically meaningful increase in the proportion of patients achieving a final post-PCI FFR ≥0.90 compared to standard care. Following angiographically successful PCI procedures, 260 patients will be randomized (1:1) to receive either a physiology-guided incremental optimization strategy (intervention group) or blinded post-PCI coronary physiology measurements (control group). Patients undergoing successful, standard-of-care PCI for either stable angina or non-ST-segment-elevation myocardial infarction who meet the study's inclusion and exclusion criteria will be eligible for randomization. The primary endpoint is defined as the proportion of patients with a final post-PCI FFR result ≥0.90. Secondary endpoints include change from baseline in Seattle Angina Questionnaire and EQ-5D-5L scores at 3 months and the rate of target vessel failure and its components (cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalization with target vessel revascularization) at 3 months and 1 year. 260 individual patients were successfully randomized between March 2018 and November 2019. Key baseline demographics of the study population are reported within. TARGET FFR is an investigator-initiated, prospective, single-center, randomized controlled trial of an FFR-guided PCI optimization strategy. The study has completed recruitment and is now in clinical follow-up. It is anticipated that primary results will be presented in Autumn 2020. ClinicalTrials.gov Identifier: NCT03259815. [Correction added on Apr 3 2020, after first online publication: Clinical Trials identifier added.].",2020,Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis.,"['260 patients', ""Patients undergoing successful, standard-of-care PCI for either stable angina or non-ST-segment-elevation myocardial infarction who meet the study's inclusion and exclusion criteria will be eligible for randomization"", '260 individual patients were successfully randomized between March 2018 and November 2019']","['physiology-guided percutaneous coronary intervention', 'FFR', 'physiology-guided incremental optimization strategy (intervention group) or blinded post-PCI coronary physiology measurements (control group']","['proportion of patients with a final post-PCI FFR result ≥0.90', 'change from baseline in Seattle Angina Questionnaire and EQ-5D-5L scores at 3 months and the rate of target vessel failure and its components (cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalization with target vessel revascularization']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",260.0,0.129999,Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis.,"[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Collison', 'Affiliation': 'West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'McClure', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.'}]",Clinical cardiology,['10.1002/clc.23342']
553,30707210,Early Protocolized Versus Usual Care Rehabilitation for Pediatric Neurocritical Care Patients: A Randomized Controlled Trial.,"OBJECTIVE
s: Few feasibility, safety, and efficacy data exist regarding ICU-based rehabilitative services for children. We hypothesized that early protocolized assessment and therapy would be feasible and safe versus usual care in pediatric neurocritical care patients.
DESIGN
Randomized controlled trial.
SETTING
Three tertiary care PICUs in the United States.
PATIENTS
Fifty-eight children between the ages of 3-17 years with new traumatic or nontraumatic brain insult and expected ICU admission greater than 48 hours.
INTERVENTIONS
Early protocolized (consultation of physical therapy, occupational therapy, and speech and language therapy within 72 hr ICU admission, n = 26) or usual care (consultation per treating team, n = 32).
MEASUREMENTS AND MAIN RESULTS
Primary outcomes were consultation timing, treatment type, and frequency of deferrals and safety events. Secondary outcomes included patient and family functional and quality of life outcomes at 6 months. Comparing early protocolized (n = 26) and usual care groups (n = 32), physical therapy was consulted during the hospital admission in 26 of 26 versus 28 of 32 subjects (p = 0.062) on day 2.4 ± 0.8 versus 7.7 ± 4.8 (p = 0.001); occupational therapy in 26 of 26 versus 23 of 32 (p = 0.003), on day 2.3 ± 0.6 versus 6.9 ± 4.8 (p = 0.001); and speech and language therapy in 26 of 26 versus 17 of 32 (p = 0.011) on day 2.3 ± 0.7 versus 13.0 ± 10.8 (p = 0.026). More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001). Eleven sessions were discontinued early: nine during physical therapy and two during occupational therapy, none impacting patient outcome. There were no group differences in functional or quality of life outcomes.
CONCLUSIONS
A protocol for early personalized rehabilitation by physical therapy, occupational therapy, and speech and language therapy in pediatric neurocritical care patients could be safely implemented and led to more ICU-based treatment sessions, accelerating the temporal profile and changing composition of interventions versus usual care, but not altering the total dose of rehabilitation.",2019,More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001).,"['children', 'Pediatric Neurocritical Care Patients', 'Fifty-eight children between the ages of 3-17 years with new traumatic or nontraumatic brain insult and expected ICU admission greater than 48 hours', 'Three tertiary care PICUs in the United States', 'pediatric neurocritical care patients']","['Early Protocolized Versus Usual Care Rehabilitation', 'physical therapy, occupational therapy, and speech and language therapy', 'Early protocolized (consultation of physical therapy, occupational therapy, and speech and language therapy within 72\u2009hr ICU admission, n = 26) or usual care (consultation per treating team, n = 32', 'ICU-based rehabilitative services']","['functional or quality of life outcomes', 'consultation timing, treatment type, and frequency of deferrals and safety events', 'patient and family functional and quality of life outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C1046445', 'cui_str': 'Picus'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",58.0,0.0556068,More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001).,"[{'ForeName': 'Ericka L', 'Initials': 'EL', 'LastName': 'Fink', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, PA.""}, {'ForeName': 'Sue R', 'Initials': 'SR', 'LastName': 'Beers', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Houtrow', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Rudolph', 'Initials': 'R', 'LastName': 'Richichi', 'Affiliation': 'Statistical Analysis and Measurement Consultants Inc., Lanexa, VA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Burns', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Doughty', 'Affiliation': ""Division of Critical Care Medicine, Department of Psychiatry, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ortiz-Aguayo', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Madurski', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, PA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Valenta', 'Affiliation': 'Professional Practice and Education, Jefferson Hospital, Jefferson Hills, PA.'}, {'ForeName': 'Maddie', 'Initials': 'M', 'LastName': 'Chrisman', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Golightly', 'Affiliation': ""Audiology Communications Disorders, Department of Audiology and Speech-Language Pathology, UPMC Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kiger', 'Affiliation': ""Division of Occupational Therapy and Physical Therapy, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Patrick', 'Affiliation': ""Departments of Occupational and Physical Therapy, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Amery', 'Initials': 'A', 'LastName': 'Treble-Barna', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Pollon', 'Affiliation': 'Special Needs Child Advocate and Study Stakeholder, Pittsburgh, PA.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Smith', 'Affiliation': ""Division of Critical Care, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kochanek', 'Affiliation': ""Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, PA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001881']
554,30795852,Increased production and reduced urinary buffering of acid in uric acid stone formers is ameliorated by pioglitazone.,"Idiopathic uric acid nephrolithiasis is characterized by an overly acidic urine pH caused by the combination of increased acid production and inadequate buffering of urinary protons by ammonia. A large proportion of uric acid stone formers exhibit features of the metabolic syndrome. We previously demonstrated that thiazolidinediones improved the urinary biochemical profile in an animal model of the metabolic syndrome. In this proof-of-concept study, we examined whether the thiazolidinedione pioglitazone can also ameliorate the overly acidic urine in uric acid stone formers. Thirty-six adults with idiopathic uric acid nephrolithiasis were randomized to pioglitazone 30 mg/day or matching placebo for 24 weeks. At baseline and study end, participants underwent collection of blood and 24-hour urine in an inpatient research unit while consuming a fixed metabolic diet, followed by assessment of the ammoniagenic response to an acute oral acid load. Twenty-eight participants completed the study. Pioglitazone treatment improved features of the metabolic syndrome. Pioglitazone also reduced net acid excretion and increased urine pH (5.37 to 5.59), the proportion of net acid excreted as ammonium, and ammonium excretion in response to an acute acid load, whereas these parameters were unchanged with placebo. Treatment of patients with idiopathic uric acid nephrolithiasis with pioglitazone for 24 weeks led to a reduction in the acid load presented to the kidney and a more robust ammoniagenesis and ammonium excretion, resulting in significantly higher urine pH. Future studies should consider the impact of this targeted therapy on uric acid stone formation.",2019,"Pioglitazone also reduced net acid excretion and increased urine pH (5.37 to 5.59), the proportion of net acid excreted as ammonium, and ammonium excretion in response to an acute acid load, whereas these parameters were unchanged with placebo.","['patients with idiopathic uric acid nephrolithiasis with', 'Thirty-six adults with idiopathic uric acid nephrolithiasis', 'Twenty-eight participants completed the study']","['thiazolidinedione pioglitazone', 'Pioglitazone', 'placebo', 'pioglitazone', 'pioglitazone 30 mg/day or matching placebo', 'thiazolidinediones']","['metabolic syndrome', 'net acid excretion and increased urine pH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0558595', 'cui_str': 'Uric acid renal calculus (disorder)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1127433', 'cui_str': 'pioglitazone 30 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0042044', 'cui_str': 'Urine pH test (procedure)'}]",36.0,0.0409921,"Pioglitazone also reduced net acid excretion and increased urine pH (5.37 to 5.59), the proportion of net acid excreted as ammonium, and ammonium excretion in response to an acute acid load, whereas these parameters were unchanged with placebo.","[{'ForeName': 'Naim M', 'Initials': 'NM', 'LastName': 'Maalouf', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Poindexter', 'Affiliation': 'Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Adams-Huet', 'Affiliation': 'Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Orson W', 'Initials': 'OW', 'LastName': 'Moe', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Department of Physiology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Sakhaee', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA. Electronic address: Khashayar.sakhaee@utsouthwestern.edu.'}]",Kidney international,['10.1016/j.kint.2018.11.024']
555,31157964,Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer.,"BACKGROUND
Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostate cancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival in men with metastatic, hormone-sensitive prostate cancer.
METHODS
In this open-label, randomized, phase 3 trial, we assigned patients to receive testosterone suppression plus either open-label enzalutamide or a standard nonsteroidal antiandrogen therapy (standard-care group). The primary end point was overall survival. Secondary end points included progression-free survival as determined by the prostate-specific antigen (PSA) level, clinical progression-free survival, and adverse events.
RESULTS
A total of 1125 men underwent randomization; the median follow-up was 34 months. There were 102 deaths in the enzalutamide group and 143 deaths in the standard-care group (hazard ratio, 0.67; 95% confidence interval [CI], 0.52 to 0.86; P = 0.002). Kaplan-Meier estimates of overall survival at 3 years were 80% (based on 94 events) in the enzalutamide group and 72% (based on 130 events) in the standard-care group. Better results with enzalutamide were also seen in PSA progression-free survival (174 and 333 events, respectively; hazard ratio, 0.39; P<0.001) and in clinical progression-free survival (167 and 320 events, respectively; hazard ratio, 0.40; P<0.001). Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively). Fatigue was more common in the enzalutamide group; seizures occurred in 7 patients in the enzalutamide group (1%) and in no patients in the standard-care group.
CONCLUSIONS
Enzalutamide was associated with significantly longer progression-free and overall survival than standard care in men with metastatic, hormone-sensitive prostate cancer receiving testosterone suppression. The enzalutamide group had a higher incidence of seizures and other toxic effects, especially among those treated with early docetaxel. (Funded by Astellas Scientific and Medical Affairs and others; ENZAMET (ANZUP 1304) ANZCTR number, ACTRN12614000110684; ClinicalTrials.gov number, NCT02446405; and EU Clinical Trials Register number, 2014-003190-42.).",2019,"Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively).","['men with castration-resistant prostate cancer', 'Metastatic Prostate Cancer', 'men with metastatic, hormone-sensitive prostate cancer receiving testosterone suppression', 'men with metastatic, hormone-sensitive prostate cancer', 'A total of 1125 men']","['enzalutamide', 'Enzalutamide with Standard First-Line Therapy', 'testosterone suppression plus either open-label enzalutamide or a standard nonsteroidal antiandrogen therapy (standard-care group', 'docetaxel']","['seizures and other toxic effects', 'progression-free survival as determined by the prostate-specific antigen (PSA) level, clinical progression-free survival, and adverse events', 'adverse events', 'seizures', 'PSA progression-free survival', 'progression-free and overall survival', 'Fatigue', 'overall survival', 'clinical progression-free survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1320169', 'cui_str': 'AntiAndrogens, Nonsteroidal'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",1125.0,0.118426,"Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively).","[{'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Martin', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Begbie', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Xanthi', 'Initials': 'X', 'LastName': 'Coskinas', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Wendy E', 'Initials': 'WE', 'LastName': 'Hague', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Horvath', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Lawrence', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McCaffrey', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'McDermott', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McJannett', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'North', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Parnis', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Parulekar', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Pook', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'M Neil', 'Initials': 'MN', 'LastName': 'Reaume', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Shahneen K', 'Initials': 'SK', 'LastName': 'Sandhu', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'T Hsiang', 'Initials': 'TH', 'LastName': 'Tan', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Thomson', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Tu', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Vera-Badillo', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Yip', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Alison Y', 'Initials': 'AY', 'LastName': 'Zhang', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Zielinski', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': ""From Monash University (I.D.D., M.F., D.W.P.), Eastern Health (I.D.D.), Australian Urology Associates (M.F.), Monash Health (D.W.P.), and the Peter MacCallum Cancer Centre and the University of Melbourne (S.K.S., S.G.W.), Melbourne, VIC, the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (A.J.M., M.R.S., X.C., W.E.H., E.T., S.Y., A.Y.Z.), the Chris O'Brien Lifehouse (M.R.S., L.G.H., A.Y.Z.), the University of Sydney (L.G.H., G.M.), Royal Prince Alfred Hospital (L.G.H.), Kinghorn Cancer Centre, St. Vincent's Hospital, and Garvan Institute of Medical Research (A.M.J.), Macquarie University (A.Y.Z.), and Western Sydney University (R.R.Z.), Sydney, Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (M.R.S.), Port Macquarie Base Hospital and Mid North Coast Cancer Institute Port Macquarie, Port Macquarie, NSW (S.B.), Sydney Adventist Hospital, Wahroonga, NSW (G.M.), the ANZUP Cancer Trials Group, Camperdown, NSW (M.M.), the Adelaide Cancer Centre and the University of Adelaide (F.P.) and the Royal Adelaide Hospital (T.H.T.), Adelaide, SA, and Orange Health Service, Central West Cancer Care Centre, Orange, NSW (R.R.Z.) - all in Australia; BC Cancer and the University of British Columbia, Vancouver (K.N.C.), the Cross Cancer Institute and the University of Alberta, Edmonton (S.A.N.), Canadian Cancer Trials Group, Queen's University (W.P., F.V.-B.), and the Kingston Health Sciences Center (F.V.-B.), Kingston, ON, and the University of Ottawa and the Ottawa Hospital Research Institute, Ottawa (M.N.R.) - all in Canada; Guy's and St. Thomas' NHS Foundation Trust Biomedical Research Centre, Cancer Research UK and King's College London, and Sarah Cannon Research UK, London (S.C.), and the Royal Cornwall Hospital, Truro (A. Thomson) - all in the United Kingdom; Auckland City Hospital, Auckland (N.J.L.), and the Waikato District Health Board, Hamilton (A. Tan) - both in New Zealand; Cancer Trials Ireland (J.M., R.M.), Mater Misericordiae University Hospital (J.M.), and St. Vincent's University Hospital and University College Dublin (R.M.D.) - all in Dublin; and Dana-Farber Cancer Institute and Harvard Medical School (C.J.S.) - both in Boston.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1903835']
556,32145441,A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings.,"INTRODUCTION
Equitable delivery of advance care planning and symptom management among patients is crucial to improving cancer care. Existing interventions to improve the uptake of these services have predominantly occurred in clinic settings and are limited in their effectiveness, particularly among low-income and minority populations.
METHODS
The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings. The intervention provides a lay health worker to all patients newly diagnosed with cancer and aims to educate and activate patients to engage in advance care planning and symptom management with their oncology providers. In this randomized clinical trial, we will evaluate the effect on quality of life (primary outcome) using the validated Functional Assessment of Cancer Therapy - General Survey, at enrollment, 4- and 12- months post-enrollment. We will examine between-group differences on our secondary outcomes of patient activation, patient satisfaction with healthcare decision-making, and symptom burden (at enrollment, 4- and 12-months post-enrollment), and total healthcare use and healthcare costs (at 12-months post-enrollment).
DISCUSSION
Multilevel approaches are urgently needed to improve cancer care delivery among low-income and minority patients diagnosed with cancer in community settings. The current study describes the LEAPS intervention, the study design, and baseline characteristics of the community centers participating in the study. ClinicalTrials.gov Registration #NCT03699748.",2020,"METHODS
The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings.","['community centers participating in the study', 'minority patients diagnosed with cancer in community settings', 'low-income and minority employees diagnosed with cancer in outpatient community settings', 'and minority hourly-wage workers with cancer, in two community settings', 'The ""Lay health worker Educates Engages and Activates Patients to', 'patients newly diagnosed with cancer']","['advance care planning and symptom management among low-income', 'LEAPS intervention', 'Share (LEAPS)"" intervention', 'multi-level intervention']","['quality of life', 'total healthcare use and healthcare costs', 'patient activation, patient satisfaction with healthcare decision-making, and symptom burden']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.104465,"METHODS
The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings.","[{'ForeName': 'Manali I', 'Initials': 'MI', 'LastName': 'Patel', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America; Medical Services, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, United States of America; Center for Primary Care and Outcomes Research/Health Research and Policy, Stanford University School of Medicine, Stanford, CA, United States of America. Electronic address: manalip@stanford.edu.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Khateeb', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America.'}, {'ForeName': 'Tumaini', 'Initials': 'T', 'LastName': 'Coker', 'Affiliation': ""Seattle Children's Research Institute, Seattle, WA, United States of America; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105971']
557,32147571,A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures.,"BACKGROUND
Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue.
METHODS
A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12-60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored.
DISCUSSION
This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.",2020,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","['Disease-free breast cancer survivors (n\xa0=\xa0422) who completed', 'Cancer-related fatigue', 'University of Rochester Medical Center (URMC']","['bupropion', 'placebo', 'chemotherapy', 'Behavioral interventions include exercise and cognitive-behavioral therapy']","['efficacy and tolerability', 'cognition and symptomatology', 'fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F', 'cancer-related fatigue', 'quality of life, depression, and drug tolerability']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",422.0,0.134713,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","[{'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA. Electronic address: heather.jim@moffitt.org.'}, {'ForeName': 'Aasha I', 'Initials': 'AI', 'LastName': 'Hoogland', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Hyo Sook', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Heckler', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Janelsins', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Williams', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Julienne', 'Initials': 'J', 'LastName': 'Bower', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Zeruesenay', 'Initials': 'Z', 'LastName': 'Desta', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Margarita Bobonis', 'Initials': 'MB', 'LastName': 'Babilonia', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Morrow', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Peppone', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105976']
558,32061969,Athletes for life: Rationale and methodology of a community- and family-based randomized controlled trial to promote cardiovascular fitness among primarily Latino families.,"BACKGROUND
Community-based programs have had modest success in combating obesity in Latino populations. Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs. Because improvements in cardiorespiratory fitness confer health benefits, regardless of weight, they offer an alternative to obesity-focused approaches. We describe the rationale and design of Athletes for Life (AFL), a community- and family-based intervention for Latino families.
METHODS/DESIGN
This two-group randomized controlled trial will test the efficacy of AFL for improving cardiorespiratory fitness and diet in 6- to 11-year-old children (N = 160) and their parents, relative to a wait-list control group. Children will participate in 12 weeks of semiweekly sports skill programing and nutrition sessions. Concurrently, parents will participate in sports-focused activity and behavior change sessions that focus on nutrition, chronic disease prevention, and healthy eating. Cardiovascular fitness will be measured by the 1-mile run and 3-min step-test for both parents and children. Secondary outcomes include changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein).
DISCUSSION
AFL, implemented with a strong community partnership, will provide a test of the efficacy of culturally tailored intervention programming to promote positive health behaviors and improve health outcomes in Latino families. Intervention content, structure, and messaging will provide guidance for future methods to engage Latino families in health promotion programs that highlight their cultural norms, and beliefs.
TRIAL REGISTRATION
Clinicaltrials.gov Identifier NCT03761589 (12/3/2018).",2020,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","['Latino families', '6- to 11-year-old children (N\u202f=\u202f160) and their parents, relative to a wait-list control group', 'Latino populations', 'Athletes for Life (AFL), a community- and family-based intervention for Latino families', 'primarily Latino families']","['semiweekly sports skill programing and nutrition sessions', 'AFL']","['changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein', 'cardiorespiratory fitness and diet', 'health outcomes', 'Cardiovascular fitness']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.040074,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Szeszulski', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; The University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research, 7000 Fannin Street, #1200, Houston, TX 77030, USA; The University of Texas Health Science Center at Houston, Austin Campus, Michael Susan Dell Center for Healthy Living, 1616 Guadalupe Street, Suite 6.300, Austin, TX 78701, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Arizona State University, Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service & Community Solutions, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Arizona State University, Edson College of Nursing and Health Innovation, 550 North 3rd Street, Suite 301, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ray', 'Affiliation': 'City of Phoenix Parks and Recreation, 212 East Alta Vista Rd, Phoenix, AZ 85042, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Behar', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Eckert', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Mays Cancer Center at UT Health San Antonio MD Anderson, 7979 Wurzbach Rd, San Antonio, TX 78229, USA.'}, {'ForeName': 'Anabell', 'Initials': 'A', 'LastName': 'Lorenzo-Quintero', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Hartmann Manrique', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA. Electronic address: ncrespo@sdsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105956']
559,32064987,Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels.,"In the randomized, phase 3, MDS-005 study (NCT01029262), lenalidomide-induced red blood cell transfusion independence (RBC-TI) in 27% of transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes (MDS) ineligible for or refractory to erythropoiesis-stimulating agents. To determine the influence of erythropoietin (EPO) level on response, 155 patients treated with lenalidomide in MDS-005 were categorized into four groups by baseline EPO level. The EPO >500 mU/mL group had higher RBC transfusion burden and the lowest proportion of patients with ring sideroblasts ≥15% versus lower EPO groups. Achievement of RBC-TI ≥8 weeks inversely correlated with EPO level, ranging from 42.5 to 15.5%. EPO level did not affect erythroid hematologic improvement response (36.2-44.4%). This analysis suggests patients with lower EPO levels experience the strongest benefit from lenalidomide. Although meaningful improvements were observed in some patients with EPO level >500 mU/mL, new treatments are needed for this population.",2020,The EPO >500 mU/mL group had higher RBC transfusion burden and the lowest proportion of patients with ring sideroblasts ≥15% versus lower EPO groups.,"['red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes', '27% of transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes (MDS) ineligible for or refractory to erythropoiesis-stimulating agents', '155 patients treated with lenalidomide in MDS-005']",['erythropoietin (EPO'],"['RBC transfusion burden', 'red blood cell transfusion independence (RBC-TI', 'erythroid hematologic improvement response', 'Achievement of RBC-TI', 'EPO level']","[{'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0133243,The EPO >500 mU/mL group had higher RBC transfusion burden and the lowest proportion of patients with ring sideroblasts ≥15% versus lower EPO groups.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Santini', 'Affiliation': 'MDS Unit, Hematology, AOU Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Almeida', 'Affiliation': 'Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon, Portugal.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Marien Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Skikne', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Beach', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Tu', 'Affiliation': 'Formerly Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': ""Service d'Hématologie Séniors, Hôpital Saint-Louis, Université Paris 7, Paris, France.""}]",Leukemia & lymphoma,['10.1080/10428194.2020.1719088']
560,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
561,32242395,"""Efficacy and safety of Liangxue Jiedu decoction for the treatment of progressive psoriasis vulgaris: a multicenter, randomized, controlled study"".","OBJECTIVE
To determine the clinical efficacy and safety of Liangxue Jiedu decoction (LJD) for the treatment of progressive psoriasis vulgaris and to provide the basis for the development of a standardized treatment protocol for psoriasis vulgaris.
METHODS
In this multicenter, randomized, controlled study, patients with blood-heat type psoriasis were randomly assigned to receive either Chinese herbal medicine (LJD; treatment group) or Western Medicine (cetirizine hydrochloride, vitamin C, and vitamin B complex; control group). Psoriasis Area and Severity Index (PASI) scores were calculated in addition to the number of patients who achieved ≥ 50% or ≥ 75% improvement in PASI score from baseline. The change in symptoms of Chinese medicine (color of rash, burning sensation, itchiness, severity of irritation, and anger) was evaluated and safety was assessed as adverse events and laboratory analysis. t test, independent sample non-parametric test and χ2 test were used to analyze the results.
RESULTS
A total of 238 participants were included in the study [treatment group, n = 122 (PP analysis 117); control group, n = 116 (PP analysis 104)]. LJD treatment was associated with a significant improvement in skin lesions and symptoms compared with Western Medicine treatment. At the end of the 8-week treatment period, 23.77% (PP analysis 24.79%) of patients in the treatment group had achieved PASI75 and 57.38% (PP analysis 58.97%) had achieved PASI50; the corresponding figures in the control group were 9.48% (9.62%) and 25.00% (25.00%), respectively. The between-group differences were statistically significant (P < 0.05).
CONCLUSION
Treatment of psoriasis vulgaris of the blood-heat type using LJD was associated with significantly better outcomes compared with those achieved using standard Western Medicine.",2020,"CONCLUSION
Treatment of psoriasis vulgaris of the blood-heat type using LJD was associated with significantly better outcomes compared with those achieved using standard Western Medicine.","['A total of 238 participants were included in the study [treatment group, n = 122 (PP analysis 117); control group, n = 116 (PP analysis 104', 'psoriasis vulgaris', 'patients with blood-heat type psoriasis', 'progressive psoriasis vulgaris']","['Liangxue Jiedu decoction (LJD', 'Chinese herbal medicine (LJD; treatment group) or Western Medicine (cetirizine hydrochloride, vitamin C, and vitamin B complex; control group', 'Liangxue Jiedu decoction', 'LJD']","['PASI50', 'Psoriasis Area and Severity Index (PASI) scores', 'Efficacy and safety', 'PASI score', 'change in symptoms of Chinese medicine (color of rash, burning sensation, itchiness, severity of irritation, and anger', 'skin lesions and symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0700480', 'cui_str': 'Cetirizine hydrochloride'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}]",238.0,0.0877539,"CONCLUSION
Treatment of psoriasis vulgaris of the blood-heat type using LJD was associated with significantly better outcomes compared with those achieved using standard Western Medicine.","[{'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Ulcer Vascular Surgery, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Xiumin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Dermatology Department, Beijing Tong Ren Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Dermatology Department, Beijing Tong Ren Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Dermatology Department, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Dermatology Department, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Dermatology Department, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Dermatology Department, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Chunguan', 'Initials': 'C', 'LastName': 'Tong', 'Affiliation': 'Dermatology Department, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Chu', 'Affiliation': 'Dermatology Department, Beijing Anzhen Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Dermatology Department, Beijing Anzhen Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Dermatology Department, Beijing Xuanwu Hospital Affiliated to Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Xuying', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Ulcer Vascular Surgery, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
562,32242398,"""Efficacy and safety of the Qiguiyin formula in severe pneumonia: study protocol for a randomized, double-blind, placebo-controlled clinical trial"".","OBJECTIVE
To evaluate the clinical efficacy and safety of Qiguiyin (QGY) formula in patients with severe pneumonia in China compared with a placebo.
METHODS
This is a multicenter double-blind, placebo-controlled, randomized clinical trial with two parallel arms. There will be 530 patients enrolled and randomized into either the experimental group (QGY formula) or the control group (placebo). Therapies for patients in the two groups above will be based on the conventional therapy. The primary outcome is 28-day mortality. Secondary outcomes include: (a) duration of hospital stay; (b) duration of time in the intensive care unit (ICU) stays; (c) duration of mechanical ventilation; (d) antibiotic DDD value(which means the doses of antibotics during the treatment period); (e) serum procalcitonin (PCT) level; (f) serum C-reactive protein (CRP) level; (g) Pneumonia severity index (PSI) score; (h) Sequential Organ Failure Assessment (SOFA) score; (i) sputum culture results; (j) blood routine examination results; (k) routine urine test results; (l) stool routine examination results; (m) electrocardiogram results; (n) alanine aminotransferase levels; (o) aspartate amino transferase levels; (p) total bilirubin; (q) creatinine levels; (r) urea nitrogen levels; and (s) adverse events.
ETHICS AND DISSEMINATION
The protocol has been approved by the Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine, Affiliated with Capital Medical University (2018BL- 053-02). This trial aims to provide evidence for QGY formula combined with conventional therapy in treating patients with severe bacterial pneumonia, and to verify the clinical effectiveness and safety of QGY formula in China compared with placebo. Additionally, this trial will reveal the effect of QGY formula on delaying/reversing the characteristics of drug-resistant bacteria.",2020,Secondary outcomes include: (a) duration of hospital stay; (b) duration of time in the intensive care unit (ICU) stays; (c) duration of mechanical ventilation; (d,"['patients with severe bacterial pneumonia', 'Beijing Hospital of Traditional Chinese Medicine, Affiliated with Capital Medical University (2018BL- 053-02', '530 patients enrolled', 'patients with severe pneumonia in China compared with a placebo', 'severe pneumonia']","['QGY formula combined with conventional therapy', 'Qiguiyin (QGY) formula', 'placebo', 'Qiguiyin formula', 'control group (placebo']","['Efficacy and safety', 'e) serum procalcitonin (PCT) level; (f) serum C-reactive protein (CRP) level; (g) Pneumonia severity index (PSI) score; (h) Sequential Organ Failure Assessment (SOFA) score; (i) sputum culture results; (j) blood routine examination results; (k) routine urine test results; (l) stool routine examination results; (m) electrocardiogram results; (n) alanine aminotransferase levels; (o) aspartate amino transferase levels; (p) total bilirubin; (q) creatinine levels; (r) urea nitrogen levels; and (s) adverse events', ' (a) duration of hospital stay; (b) duration of time in the intensive care unit (ICU) stays; (c) duration of mechanical ventilation', '28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C1321595', 'cui_str': 'Pneumonia severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0040676', 'cui_str': 'Transferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",530.0,0.679175,Secondary outcomes include: (a) duration of hospital stay; (b) duration of time in the intensive care unit (ICU) stays; (c) duration of mechanical ventilation; (d,"[{'ForeName': 'Po', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Emergency Medicine, Beijing Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Emergency Medicine, Beijing Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Laboratory of Infection and Immunity, Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Laboratory of Infection and Immunity, Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency Medicine, Beijing Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Beijing Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
563,32239306,Cognitive load in 3d and 2d minimally invasive colorectal surgery.,"BACKGROUND
Three-dimensional (3d) laparoscopy has been introduced to enhance depth perception and facilitate surgical operations. The aim of this study was to compare cognitive load during 3d and 2d laparoscopic procedures.
METHODS
Two subjective questionnaires (the Simulator Sickness Questionnaire and the NASA task load index) were used to prospectively collect data regarding cognitive load in surgeons performing 2d and 3d laparoscopic colorectal resections. Moreover, the perioperative results of 3d and 2d laparoscopic operations were analyzed.
RESULTS
A total of 313 patients were included: 82 in the 2d group and 231 in the 3d group. The NASA TLX results did not reveal significantly major cognitive load differences in the 3d group compared with the 2d group; the SSQ results were better in the 3d group than in the 2d group in terms of general discomfort, whereas difficulty concentrating, difficulty focusing, and fatigue were more frequent in 3d operations than in 2d operations (p = 0.001-0.038). The results of age, sex, and ASA score were comparable between the two groups (p = 0.299-0.374). The median operative time showed no statistically significant difference between the 3d and 2d groups (median, IQR, 2d 150 min [120-180]-3d 160 min [130-190] p = 0.611). There was no statistically significant difference in the risk of severe complications between patients in the 3d group and in the 2d group (2d 7 [8.54%] vs 3d 21 [9.1%], p = 0.271). The median hospitalization time and the reoperation rate showed no difference between the 2d and 3d operations (p = 0.417-0.843).
CONCLUSION
The NASA TLX did not reveal a significant difference in cognitive load between the 2d and 3d groups, whereas data reported by the SSQ showed a mild risk of cognitive load in the 3d group. Furthermore, 3d laparoscopic surgery revealed the same postoperative results as 2d standard laparoscopy.",2020,"The NASA TLX results did not reveal significantly major cognitive load differences in the 3d group compared with the 2d group; the SSQ results were better in the 3d group than in the 2d group in terms of general discomfort, whereas difficulty concentrating, difficulty focusing, and fatigue were more frequent in 3d operations than in 2d operations (p = 0.001-0.038).","['Cognitive load in 3d and 2d minimally invasive colorectal surgery', 'A total of 313 patients were included: 82 in the 2d group and 231 in the 3d group']",[],"['cognitive load', 'mild risk of cognitive load', 'ASA score', 'general discomfort', 'median operative time', 'median hospitalization time and the reoperation rate', 'risk of severe complications', 'difficulty concentrating, difficulty focusing, and fatigue', 'major cognitive load differences']","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0332165', 'cui_str': 'Mild risk of'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0858924', 'cui_str': 'General discomfort'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0278210', 'cui_str': 'Problem of visual accommodation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",313.0,0.0371449,"The NASA TLX results did not reveal significantly major cognitive load differences in the 3d group compared with the 2d group; the SSQ results were better in the 3d group than in the 2d group in terms of general discomfort, whereas difficulty concentrating, difficulty focusing, and fatigue were more frequent in 3d operations than in 2d operations (p = 0.001-0.038).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Inama', 'Affiliation': 'General and Mininvasive Surgery Department, Pederzoli Hospital, Via Monte Baldo 24, Peschiera del Garda, 37019, Verona, Italy. inama.marco@gmail.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Spolverato', 'Affiliation': 'Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padova, Italy.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Impellizzeri', 'Affiliation': 'General and Mininvasive Surgery Department, Pederzoli Hospital, Via Monte Baldo 24, Peschiera del Garda, 37019, Verona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bacchion', 'Affiliation': 'General and Mininvasive Surgery Department, Pederzoli Hospital, Via Monte Baldo 24, Peschiera del Garda, 37019, Verona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Creciun', 'Affiliation': 'General and Mininvasive Surgery Department, Pederzoli Hospital, Via Monte Baldo 24, Peschiera del Garda, 37019, Verona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Casaril', 'Affiliation': 'General and Mininvasive Surgery Department, Pederzoli Hospital, Via Monte Baldo 24, Peschiera del Garda, 37019, Verona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Moretto', 'Affiliation': 'General and Mininvasive Surgery Department, Pederzoli Hospital, Via Monte Baldo 24, Peschiera del Garda, 37019, Verona, Italy.'}]",Surgical endoscopy,['10.1007/s00464-020-07524-5']
564,30946442,Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial.,"Importance
Ibuprofen is an effective analgesic after tonsillectomy alone or tonsillectomy with adenoidectomy, but concerns remain about whether it increases postoperative hemorrhage.
Objective
To investigate the effect of ibuprofen compared with acetaminophen on posttonsillectomy bleeding (PTB) requiring surgical intervention in children.
Design, Setting, and Participants
A multicenter, randomized, double-blind noninferiority trial was conducted at 4 tertiary medical centers (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center, San Diego, California; Naval Medical Center, Portsmouth, Virginia; Madigan Army Medical Center, Tacoma, Washington). A total of 1832 children were assessed for eligibility (presence of sleep-disordered breathing or obstructive sleep apnea, adenotonsillar hypertrophy, or infectious tonsillitis undergoing extracapsular tonsillectomy by electrocautery). Of these, 1091 were excluded because they did not meet eligibility criteria (n = 681) or refused to participate (n = 410); thus, 741 children aged 2 to 18 years undergoing tonsillectomy alone or tonsillectomy with adenoidectomy were enrolled between May 3, 2012, and January 20, 2017.
Interventions
Participants were randomized to receive ibuprofen, 10 mg/kg (n = 372), or acetaminophen, 15 mg/kg (n = 369), every 6 hours for the first 9 postoperative days.
Main Outcomes and Measures
Rate and severity of posttonsillectomy bleeding were recorded using a postoperative bleeding severity scale: type 1 (bleeds that were observed at home or evaluated in the emergency department without further intervention), type 2 (bleeds that required readmission for observation), and type 3 (bleeds that required a return to the operating room for control of hemorrhage). Type 3 bleeding was the main outcome measure. The noninferiority margin was set at 3%, and modified intention-to-treat analysis was used.
Results
Of the 741 children enrolled, 688 children (92.8%) (median [interquartile range] age, 5 [4] years; 366 boys [53.2%]) received the study medication and were included in a modified intention-to-treat analysis. The rate of bleeding requiring operative intervention was 1.2% in the acetaminophen group and 2.9% in the ibuprofen group (difference, 1.7%; 97.5% CI upper limit, 3.8%; P = .12 for noninferiority). There were no significant adverse events or deaths.
Conclusions and Relevance
This study could not exclude a higher rate of severe bleeding in children receiving ibuprofen after tonsillectomy alone or tonsillectomy with adenoidectomy. This finding should be considered when selecting a postoperative analgesic regimen. Further studies are needed to understand if bleeding risk is affected when ibuprofen is used for a shorter duration or in combination with acetaminophen for postoperative analgesia.
Trial Registration
ClinicalTrials.gov identifier: NCT01605903.",2019,This study could not exclude a higher rate of severe bleeding in children receiving ibuprofen after tonsillectomy alone or tonsillectomy with adenoidectomy.,"['children', 'children receiving', '1091 were excluded because they did not meet eligibility criteria (n\u2009=\u2009681) or refused to participate (n\u2009=\u2009410); thus, 741 children aged 2 to 18 years undergoing tonsillectomy alone or tonsillectomy with adenoidectomy were enrolled between May 3, 2012, and January 20, 2017', ' 366 boys [53.2%]) received the study medication and were included in a modified intention-to-treat analysis', '1832 children were assessed for eligibility (presence of sleep-disordered breathing or obstructive sleep apnea, adenotonsillar hypertrophy, or infectious tonsillitis undergoing extracapsular tonsillectomy by electrocautery', '741 children enrolled, 688 children (92.8%) (median [interquartile range] age, 5 [4] years', '4 tertiary medical centers (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center, San Diego, California; Naval Medical Center, Portsmouth, Virginia; Madigan Army Medical Center, Tacoma, Washington', 'After Pediatric Tonsillectomy']","['Ibuprofen vs Acetaminophen', 'ibuprofen', 'acetaminophen', 'Ibuprofen', 'tonsillectomy alone or tonsillectomy with adenoidectomy']","['adverse events or deaths', 'type 2 (bleeds that required readmission for observation), and type 3 (bleeds that required a return to the operating room for control of hemorrhage', 'Severe Bleeding Risk', 'rate of bleeding requiring operative intervention', 'postoperative bleeding severity scale: type 1 (bleeds', 'Measures\n\n\nRate and severity of posttonsillectomy bleeding']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040425', 'cui_str': 'Tonsillitis'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4305419', 'cui_str': 'Complication of tonsil surgery with bleeding'}]",741.0,0.273179,This study could not exclude a higher rate of severe bleeding in children receiving ibuprofen after tonsillectomy alone or tonsillectomy with adenoidectomy.,"[{'ForeName': 'Gillian R', 'Initials': 'GR', 'LastName': 'Diercks', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Comins', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'Bennett Statistical Consulting Inc, Ballston Lake, New York.'}, {'ForeName': 'Thomas Q', 'Initials': 'TQ', 'LastName': 'Gallagher', 'Affiliation': 'Department of Otolaryngology, Naval Medical Center Portsmouth, Portsmouth, Virginia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Brigger', 'Affiliation': 'Department of Otolaryngology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boseley', 'Affiliation': 'Department of Otolaryngology, Madigan Army Medical Center, Tacoma, Washington.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Gaudreau', 'Affiliation': 'Department of Otolaryngology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Rogers', 'Affiliation': 'Department of Otolaryngology, Madigan Army Medical Center, Tacoma, Washington.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Setlur', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Keamy', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hartnick', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0269']
565,31261168,Complex effects of continuous vasopressor infusion on fluid responsiveness during liver resection: A randomised controlled trial.,"BACKGROUND
Fluid responsiveness is an important factor to consider for fluid volume loading during major surgery. The effect of continuous vasopressor infusion on fluid responsiveness during prolonged major surgery is a concern.
OBJECTIVE
We hypothesised that continuous vasopressor infusion during major surgery might not exert significant effects on changes in stroke volume variation (SVV) following fluid bolus infusion, and thereby on fluid responsiveness.
DESIGN
Randomised controlled trial.
SETTING
University hospital from April 2014 to August 2016.
PATIENTS
Patients undergoing liver resection who were randomised to receive continuous intravenous infusion of phenylephrine (P group), norepinephrine (N group), or no vasopressor (C group) (n=17/group). Exclusion criteria were cardiac arrhythmia and severe cardiac, pulmonary or renal dysfunction.
INTERVENTION
Patients received 4 ml kg fluid boluses of 6% hydroxyethyl starch solution when SVV was at least 12%. Vasopressors were administered continuously to maintain the systemic vascular resistance index at more than 1900 dyn s cm m.
MAIN OUTCOME MEASURES
Cardiac index and SVV were measured using the FloTrac/Vigileo system (Version 4.00). The number of fluid boluses with fluid responsiveness (i.e. >15% increase in cardiac index) was compared between groups using multilevel logistic regression analysis.
RESULTS
Numbers of fluid responsive boluses in the C, P and N groups were 12 (14%), 22 (34%) and 19 (27%), respectively. Odds ratios on fluid responsiveness for phenylephrine and norepinephrine compared with the control were 3.65 (97.5% confidence interval, 1.15 to 11.6; P = 0.012) and 2.56 (97.5% confidence interval, 0.82 to 8.00; P = 0.064), respectively. Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively).
CONCLUSION
Continuous administration of phenylephrine increased fluid responsiveness during liver resection, suggesting complex effects of continuous vasopressor infusion involving changes in cardiac preload and afterload.
TRIAL REGISTRATION
UMIN000011024.",2019,"Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively).
","['University hospital from April 2014 to August 2016', 'Patients undergoing liver resection', 'liver resection']","['continuous vasopressor infusion', 'phenylephrine', 'phenylephrine (P group), norepinephrine (N group), or no vasopressor (C group) (n=17/group', '4\u200aml\u200akg fluid boluses of 6% hydroxyethyl starch solution', 'phenylephrine and norepinephrine']","['stroke volume variation (SVV', 'number of fluid boluses with fluid responsiveness', 'cardiac index', 'SVV', 'systemic vascular resistance index', 'Odds ratios on fluid responsiveness', 'Cardiac index and SVV', 'cardiac arrhythmia and severe cardiac, pulmonary or renal dysfunction', 'fluid responsiveness']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index (observable entity)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",,0.56142,"Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively).
","[{'ForeName': 'Shiroh', 'Initials': 'S', 'LastName': 'Nakamoto', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan (SN, TT, TO, MH).'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Tatara', 'Affiliation': ''}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': ''}, {'ForeName': 'Munetaka', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001046']
566,32240629,Once-weekly rifapentine and isoniazid for tuberculosis prevention in patients with HIV taking dolutegravir-based antiretroviral therapy: a phase 1/2 trial.,"BACKGROUND
Short-course preventive therapy with 12 doses of once-weekly rifapentine (900 mg) plus isoniazid (900 mg) could greatly improve tuberculosis control, especially in areas with high co-endemicity with HIV. However, a small previous trial of such therapy with dolutegravir in healthy, HIV-negative adults was halted early after two of the four patients developed serious adverse events. Because of the potential use of this therapy, and variable safety outcomes of tuberculosis drugs seen in patients with and without HIV, we aimed to characterise safety, pharmacokinetics, and virological suppression in adults who are HIV positive.
METHODS
DOLPHIN was a phase 1/2, single-arm trial done at The Aurum Institute (Tembisa Clinical Research Site, Tembisa, South Africa), with pharmacokinetic visits done at VxPharma (Pretoria, South Africa). Adults (≥18 years) with HIV infection and undetectable viral load (<40 copies per mL) after at least 8 weeks of efavirenz-based or dolutegravir-based regimens were recruited in three consecutive groups, subject to approval by the independent safety monitoring committee. Participants received 50 mg of daily dolutegravir in place of efavirenz for 8 weeks, then began once-weekly rifapentine (900 mg)-isoniazid (900 mg) for 12 weeks. Groups 1A (n=12) and 1B (n=18) had intensive dolutegravir pharmacokinetic sampling at week 8 (before rifapentine-isoniazid), at week 11 (after the third dose of rifapentine)-isoniazid and at week 16 after the eighth dose. Group 2 (n=30) were treated with the same schedule and had sparse dolutegravir pharmacokinetic sampling at weeks 8, 11, and 16. Participants were followed 4 weeks after completion of prophylactic tuberculosis treatment. HIV viral loads were measured at baseline and at weeks 11 and 24. Primary endpoints were adverse events (grade 3 or higher) and dolutegravir population pharmacokinetics, assessed in participants who began rifapentine-isoniazid. This trial was registered at ClinicalTrials.gov, NCT03435146.
FINDINGS
Between Jan 24, 2018, and Nov 25, 2018, 61 participants were enrolled into three groups; one participant withdrew (from group 1A). 43 (70%) of 60 participants were women and all participants were black African. Median age was 40 years (IQR 35-48), CD4 cell count was 683 cells per μL (447-935), and body-mass index was 28·9 kg/m 2 (24·0-32·9). Three grade 3 adverse events occurred; two elevated creatinine and one hypertension. Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve. Overall geometric mean ratio of trough concentrations with versus without rifapentine-isoniazid was 0·53 (90% CI 0·49-0·56) though this ratio varied by day after rifapentine-isoniazid dose. All but one trough value was above the 90% maximal inhibitory concentration for dolutegravir and HIV viral loads were less than 40 copies per mL in all patients.
INTERPRETATION
Our results suggest 12 doses of once-weekly rifapentine-isoniazid can be given for tuberculosis prophylaxis to patients with HIV taking dolutegravir-based antiretroviral therapy, without dose adjustments. Further exploration of the pharmacokinetics, safety, and efficacy in children and pharmacodynamics in individuals naive to antiretroviral therapy is needed.
FUNDING
UNITAID.",2020,Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve.,"['43 (70%) of 60 participants were women and all participants were black African', 'patients with HIV taking dolutegravir-based antiretroviral therapy', 'Adults (≥18 years) with HIV infection and undetectable viral load (<40 copies per mL) after at least 8 weeks of', 'Median age was 40 years (IQR 35-48), CD4 cell count was 683 cells per μL (447-935), and body-mass index was 28·9 kg/m 2 (24·0-32·9', 'DOLPHIN was a phase 1/2, single-arm trial done at The Aurum Institute (Tembisa Clinical Research Site, Tembisa, South Africa), with pharmacokinetic visits done at VxPharma (Pretoria, South Africa', 'adults who are HIV positive', 'Between Jan 24, 2018, and Nov 25, 2018, 61 participants were enrolled into three groups; one participant withdrew (from group 1A', 'children and pharmacodynamics in individuals naive to antiretroviral therapy', 'patients with and without HIV', 'areas with high co-endemicity with HIV']","['Rifapentine-isoniazid', 'daily dolutegravir in place of efavirenz', 'rifapentine-isoniazid', 'rifapentine and isoniazid', 'rifapentine', 'isoniazid', 'efavirenz-based or dolutegravir-based regimens', 'rifapentine)-isoniazid']","['dolutegravir and HIV viral loads', 'dolutegravir clearance', 'Overall geometric mean ratio of trough concentrations', 'dolutegravir area', 'intensive dolutegravir pharmacokinetic sampling', 'HIV viral loads', 'adverse events (grade 3 or higher) and dolutegravir population pharmacokinetics', 'serious adverse events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013005', 'cui_str': 'Dolphin'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0441862', 'cui_str': 'Group 1A'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",61.0,0.385174,Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve.,"[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kdooley1@jhmi.edu.'}, {'ForeName': 'Radojkam', 'Initials': 'R', 'LastName': 'Savic', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Gupte', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Vinodh A', 'Initials': 'VA', 'LastName': 'Edward', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa; School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Environmental Health Sciences, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wolf', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Modulakgotla', 'Initials': 'M', 'LastName': 'Sebe', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Morongwe', 'Initials': 'M', 'LastName': 'Likoti', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Fyvie', 'Affiliation': 'Vx Pharma, Pretoria, South Africa.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Shibambo', 'Affiliation': 'Vx Pharma, Pretoria, South Africa.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Beattie', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Churchyard', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30032-1']
567,30860943,Patient-Centered Preference Assessment to Improve Satisfaction With Care Among Patients With Localized Prostate Cancer: A Randomized Controlled Trial.,"PURPOSE
To study the effectiveness of the Patient Preferences for Prostate Cancer Care (PreProCare) intervention in improving the primary outcome of satisfaction with care and secondary outcomes of satisfaction with decision, decision regret, and treatment choice among patients with localized prostate cancer.
METHODS
In this multicenter randomized controlled study, we randomly assigned patients with localized prostate cancer to the PreProCare intervention or usual care. Outcomes were satisfaction with care, satisfaction with decision, decision regret, and treatment choice. Assessments were performed at baseline and at 3, 6, 12, and 24 months, and were analyzed using repeated measures. We compared treatment choice across intervention groups by prostate cancer risk categories.
RESULTS
Between January 2014 and March 2015, 743 patients with localized prostate cancer were recruited and randomly assigned to receive PreProCare (n = 372) or usual care (n = 371). For the general satisfaction subscale, improvement at 24 months from baseline was significantly different between groups ( P < .001). For the intervention group, mean scores at 24 months improved by 0.44 (SE, 0.06; P < .001) from baseline. This improvement was 0.5 standard deviation, which was clinically significant. The proportion reporting satisfaction with decision and no regret increased over time and was higher for the intervention group, compared with the usual care group at 24 months ( P < .05). Among low-risk patients, a higher proportion of the intervention group was receiving active surveillance, compared with the usual care group ( P < .001).
CONCLUSION
Our patient-centered PreProCare intervention improved satisfaction with care, satisfaction with decision, reduced regrets, and aligned treatment choice with risk category. The majority of our participants had a high income, with implications for generalizability. Additional studies can evaluate the effectiveness of PreProCare as a mechanism for improving clinical and patient-reported outcomes in different settings.",2019,"For the general satisfaction subscale, improvement at 24 months from baseline was significantly different between groups ( P < .001).","['patients with localized prostate cancer to the', 'patients with localized prostate cancer', 'Between January 2014 and March 2015, 743 patients with localized prostate cancer', 'Patients With Localized Prostate Cancer', 'Prostate Cancer Care', 'n = 372) or usual care (n = 371']","['PreProCare intervention', 'PreProCare intervention or usual care', 'Care', 'PreProCare) intervention', 'PreProCare']","['satisfaction with decision, decision regret, and treatment choice', 'Satisfaction', 'satisfaction with care, satisfaction with decision, decision regret, and treatment choice', 'satisfaction with care, satisfaction with decision, reduced regrets', 'mean scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",743.0,0.0767047,"For the general satisfaction subscale, improvement at 24 months from baseline was significantly different between groups ( P < .001).","[{'ForeName': 'Ravishankar', 'Initials': 'R', 'LastName': 'Jayadevappa', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Chhatre', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Gallo', 'Affiliation': '3 Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Wittink', 'Affiliation': '4 University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Lee', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Guzzo', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Vapiwala', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Yu-Ning', 'Initials': 'YN', 'LastName': 'Wong', 'Affiliation': '5 Temple University, Philadelphia, PA.'}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Van Arsdalen', 'Affiliation': '2 Corporal Michael J. Crescenz Veterans Administration Medical Center, Philadelphia, PA.'}, {'ForeName': 'S Bruce', 'Initials': 'SB', 'LastName': 'Malkowicz', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'J Sanford', 'Initials': 'JS', 'LastName': 'Schwartz', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01091']
568,32243100,Impact of adjunctive tolvaptan on sympathetic activity in acute heart failure with preserved ejection fraction.,"AIMS
Acute decompensated heart failure (ADHF) is generally treated by decongestion using diuretic therapy. However, the use of loop diuretics is associated with increased cardiac sympathetic nerve activity (CSNA). We aimed to evaluate the effect of adjunctive tolvaptan therapy on CSNA in ADHF patients with preserved left ventricular ejection fraction (LVEF).
METHODS AND RESULTS
We enrolled 51 consecutive ADHF patients with LVEF ≥45%. Patients were randomly assigned to receive either tolvaptan add-on (n = 25) or conventional diuretic therapy (n = 26). Cardiac iodine-123 metaiodobenzylguanidine (MIBG) imaging was performed after stabilisation of heart failure symptoms, and the cardiac MIBG heart-to-mediastinum ratio (HMR) and washout rate (WR) were calculated. There were no significant differences in the body weight change and total urine volume during 2 days after randomisation or in the HMR on delayed image (HMR(d)) and WR between the tolvaptan and conventional groups. After stratification based on the median change in body weight, the patients with higher weight reduction had a significantly lower HMR(d) (P = 0.0128) and tended to have a higher WR (P = 0.0786) in the conventional group, whereas the cardiac MIBG imaging results were not influenced by body weight reduction in the tolvaptan group.
CONCLUSIONS
Adjunctive tolvaptan therapy may provide rapid decongestion without a harmful effect on CSNA in ADHF patients with preserved LVEF.",2020,There were no significant differences in the body weight change and total urine volume during 2 days after randomisation or in the HMR on delayed image (HMR(d)) and WR between the tolvaptan and conventional groups.,"['acute heart failure with preserved ejection fraction', 'ADHF patients with preserved left ventricular ejection fraction (LVEF', '51 consecutive ADHF patients with LVEF ≥45', 'ADHF patients with preserved LVEF']","['adjunctive tolvaptan', 'adjunctive tolvaptan therapy', 'Cardiac iodine-123 metaiodobenzylguanidine (MIBG', 'tolvaptan add-on (n\xa0=\xa025) or conventional diuretic therapy']","['cardiac MIBG heart-to-mediastinum ratio (HMR) and washout rate (WR', 'cardiac sympathetic nerve activity (CSNA', 'delayed image (HMR(d)) and WR', 'median change in body weight', 'body weight reduction', 'sympathetic activity', 'HMR(d', 'body weight change and total urine volume']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1609524', 'cui_str': 'ADHF'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C2346581', 'cui_str': 'IOBENGUANE SULFATE I-123'}, {'cui': 'C0047506', 'cui_str': '3-Iodobenzylguanidine'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0047506', 'cui_str': '3-Iodobenzylguanidine'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0228992', 'cui_str': 'Structure of middle cardiac nerve'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}]",51.0,0.0274829,There were no significant differences in the body weight change and total urine volume during 2 days after randomisation or in the HMR on delayed image (HMR(d)) and WR between the tolvaptan and conventional groups.,"[{'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Tamaki', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kawasaki', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kikuchi', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Kawai', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Seo', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Kiyomi', 'Initials': 'K', 'LastName': 'Kayama', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Kawahira', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Kunpei', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Tamura', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masatake', 'Initials': 'M', 'LastName': 'Fukunami', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}]",ESC heart failure,['10.1002/ehf2.12690']
569,32222042,Effects of enhanced cutaneous sensory input on interlimb strength transfer of the wrist extensors.,"The relative contribution of cutaneous sensory feedback to interlimb strength transfer remains unexplored. Therefore, this study aimed to determine the relative contribution of cutaneous afferent pathways as a substrate for cross-education by directly assessing how ""enhanced"" cutaneous stimulation alters ipsilateral and contralateral strength gains in the forearm. Twenty-seven right-handed participants were randomly assigned to 1-of-3 training groups and completed 6 sets of 8 repetitions 3x/week for 5 weeks. Voluntary training (TRAIN) included unilateral maximal voluntary contractions (MVCs) of the wrist extensors. Cutaneous stimulation (STIM), a sham training condition, included cutaneous stimulation (2x radiating threshold; 3sec; 50Hz) of the superficial radial (SR) nerve at the wrist. TRAIN + STIM training included MVCs of the wrist extensors with simultaneous SR stimulation. Two pre- and one posttraining session assessed the relative increase in force output during MVCs of isometric wrist extension, wrist flexion, and handgrip. Maximal voluntary muscle activation was simultaneously recorded from the flexor and extensor carpi radialis. Cutaneous reflex pathways were evaluated through stimulation of the SR nerve during graded ipsilateral contractions. Results indicate TRAIN increased force output compared with STIM in both trained (85.0 ± 6.2 Nm vs. 59.8 ± 6.1 Nm) and untrained wrist extensors (73.9 ± 3.5 Nm vs. 58.8 Nm). Providing 'enhanced' sensory input during training (TRAIN + STIM) also led to increases in strength in the trained limb compared with STIM (79.3 ± 6.3 Nm vs. 59.8 ± 6.1 Nm). However, in the untrained limb no difference occurred between TRAIN + STIM and STIM (63.0 ± 3.7 Nm vs. 58.8 Nm). This suggests when 'enhanced' input was provided independent of timing with active muscle contraction, interlimb strength transfer to the untrained wrist extensors was blocked. This indicates that the sensory volley may have interfered with the integration of appropriate sensorimotor cues required to facilitate an interlimb transfer, highlighting the importance of appropriately timed cutaneous feedback.",2020,Providing 'enhanced' sensory input during training (TRAIN + STIM) also led to increases in strength in the trained limb compared with STIM (79.3 ± 6.3 Nm vs. 59.8 ± 6.1 Nm).,"['wrist extensors', 'Twenty-seven right-handed participants']","['Voluntary training (TRAIN) included unilateral maximal voluntary contractions (MVCs) of the wrist extensors', 'enhanced cutaneous sensory input']","['untrained wrist extensors', 'Maximal voluntary muscle activation', 'superficial radial (SR) nerve at the wrist', 'force output during MVCs of isometric wrist extension, wrist flexion, and handgrip']","[{'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0034518', 'cui_str': 'Radial Nerve'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",27.0,0.0242219,Providing 'enhanced' sensory input during training (TRAIN + STIM) also led to increases in strength in the trained limb compared with STIM (79.3 ± 6.3 Nm vs. 59.8 ± 6.1 Nm).,"[{'ForeName': 'Trevor S', 'Initials': 'TS', 'LastName': 'Barss', 'Affiliation': 'Rehabilitation Neuroscience Laboratory, University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Klarner', 'Affiliation': 'Rehabilitation Neuroscience Laboratory, University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Rehabilitation Neuroscience Laboratory, University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Inouye', 'Affiliation': 'Rehabilitation Neuroscience Laboratory, University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'E Paul', 'Initials': 'EP', 'LastName': 'Zehr', 'Affiliation': 'Rehabilitation Neuroscience Laboratory, University of Victoria, Victoria, BC, Canada.'}]",Physiological reports,['10.14814/phy2.14406']
570,31904995,Outcomes Six Months after Delivering 100% or 70% of Enteral Calorie Requirements during Critical Illness (TARGET). A Randomized Controlled Trial.,"Rationale: The long-term effects of delivering approximately 100% of recommended calorie intake via the enteral route during critical illness compared with a lesser amount of calories are unknown. Objectives: Our hypotheses were that achieving approximately 100% of recommended calorie intake during critical illness would increase quality-of-life scores, return to work, and key life activities and reduce death and disability 6 months later. Methods: We conducted a multicenter, blinded, parallel group, randomized clinical trial, with 3,957 mechanically ventilated critically ill adults allocated to energy-dense (1.5 kcal/ml) or routine (1.0 kcal/ml) enteral nutrition. Measurements and Main Results: Participants assigned energy-dense nutrition received more calories (percent recommended energy intake, mean [SD]; energy-dense: 103% [28] vs. usual: 69% [18]). Mortality at Day 180 was similar (560/1,895 [29.6%] vs. 539/1,920 [28.1%]; relative risk 1.05 [95% confidence interval, 0.95-1.16]). At a median (interquartile range) of 185 (182-193) days after randomization, 2,492 survivors were surveyed and reported similar quality of life (EuroQol five dimensions five-level quality-of-life questionnaire visual analog scale, median [interquartile range]: 75 [60-85]; group difference: 0 [95% confidence interval, 0-0]). Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work ( n = 818). There was no observed difference in disability ( n = 1,208) or participation in key life activities ( n = 705). Conclusions: The delivery of approximately 100% compared with 70% of recommended calorie intake during critical illness does not improve quality of life or functional outcomes or increase the number of survivors 6 months later.",2020,Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work (n=818).,['3957 mechanically ventilated critically ill adults allocated to'],['energy-dense (1.5 kcal/ml) or routine (1.0 kcal/ml) enteral nutrition'],"['quality of life (EuroQol five dimensions five-level quality of life questionnaire visual analogue scale, median [IQR', 'quality of life scores, return to work and key life activities and reduce death and disability six months later', 'Mortality', 'quality of life, or functional outcomes', 'disability (n=1208) or participation in key life activities']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0560598', 'cui_str': 'kcal/mL'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]","[{'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.628334,Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work (n=818).,"[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Medicine and Radiology, Melbourne Medical School, Royal Melbourne Hospital and.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Little', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, Melbourne Medical School, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Chapman', 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Davies', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Suzie', 'Initials': 'S', 'LastName': 'Ferrie', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Camperdown, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hurford', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': ""O'Connor"", 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Peake', 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Presneill', 'Affiliation': 'Department of Medicine and Radiology, Melbourne Medical School, Royal Melbourne Hospital and.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Ridley', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Medical School, Australian National University, Canberra, Australia; and.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Discipline of Acute Care Medicine and.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Iwashyna', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201909-1810OC']
571,31945300,Early Bactericidal Activity of Different Isoniazid Doses for Drug Resistant TB (INHindsight): A Randomized Open-label Clinical Trial.,"RATIONALE
High-dose isoniazid is recommended in short-course regimens for multidrug-resistant TB (MDR-TB). The optimal dose of isoniazid and its individual contribution to efficacy against TB strains with inhA or katG mutations are unknown.
OBJECTIVE
Define the optimal dose of isoniazid for patients with isoniazid-resistant TB mediated by inhA mutations.
METHODS
AIDS Clinical Trials Group A5312 is a Phase 2A, open-label trial in which individuals with smear-positive pulmonary TB with isoniazid resistance mediated by an inhA mutation were randomized to receive isoniazid 5, 10 or 15 mg/kg daily for 7 days (inhA group), and controls with drug-sensitive TB received standard dose (5 mg/kg/day). Overnight sputum cultures were collected daily. The 7-day early bactericidal activity of isoniazid was estimated as the average daily change in log10 colony forming units on solid media (EBACFU0-7) or as time to positivity in liquid media in hours (EBATTP0-7) using nonlinear mixed effects models.
MEASUREMENTS AND MAIN RESULTS
Fifty-nine participants, 88% with cavitary disease, 20% HIV-positive, 16 with isoniazid-sensitive and 41 with isoniazid mono-resistant or MDR TB, were enrolled at one site in South Africa. Mean EBACFU0-7 at doses of 5, 10 and 15 mg/kg in the inhA group was 0.07, 0.17 and 0.22 log10CFU/mL/day, respectively, and 0.16 log10CFU/mL/day in controls. EBATTP0-7 patterns were similar. There were no drug-related Grade >3 adverse events.
CONCLUSIONS
Isoniazid 10-15 mg/kg daily had similar activity against TB strains with inhA mutations as 5 mg/kg against drug-sensitive strains. The activity of high-dose isoniazid against strains with katG mutations will be explored next. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT01936831.",2020,"There were no drug-related Grade >3 adverse events.
","['Fifty-nine participants, 88% with cavitary disease, 20% HIV-positive, 16 with isoniazid-sensitive and 41 with isoniazid mono-resistant or MDR TB, were enrolled at one site in South Africa', 'individuals with smear-positive pulmonary TB with isoniazid resistance mediated by an inhA mutation', 'Drug Resistant TB (INHindsight', 'patients with isoniazid-resistant TB mediated by inhA mutations']","['Isoniazid', 'isoniazid']",[],"[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}]",[],59.0,0.319838,"There were no drug-related Grade >3 adverse events.
","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University, Medicine, Baltimore, Maryland, United States; kdooley1@jhmi.edu.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Groote-Bidlingmaier', 'Affiliation': 'Stellenbosch University Faculty of Medicine and Health Sciences, 121470, TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hafner', 'Affiliation': 'National Institutes of Health, Division of AIDS, Bethesda, Maryland, United States.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Rosenkranz', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Elisa H', 'Initials': 'EH', 'LastName': 'Ignatius', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Nuermberger', 'Affiliation': 'Johns Hopkins University, Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moran', 'Affiliation': 'Social & Scientific Systems Inc, 43740, Silver Spring, Maryland, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'Frontier Science and Technology Research Foundation, 2402, Boston, Massachusetts, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'Nebraska Medicine, 21039, Omaha, Nebraska, United States.'}, {'ForeName': 'Naadira', 'Initials': 'N', 'LastName': 'Vanker', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Diacon', 'Affiliation': 'University of Stellenbosch, Internal Medicine, Tygerberg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-1960OC']
572,32233080,Short-term echocardiographic evaluation by global longitudinal strain in patients with heart failure treated with sacubitril/valsartan.,"AIMS
The angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan reduces mortality and hospitalizations in patients with heart failure and reduced ejection fraction (HFrEF). Favourable effects on haemodynamic and functional parameters have been observed in patients with HFrEF undergoing ARNI therapy, using standard transthoracic echocardiography. Global longitudinal strain (GLS) assessment uses a semi-automatic procedure to provide a reliable and repeatable method that improves the detection of early changes of contractile function. We aimed to assess the effects of ARNI on GLS and myocardial mechanics in patients with HFrEF.
METHODS AND RESULTS
Thirty patients with New York Heart Association class II-III HFrEF were treated with ARNI and monitored using standard echocardiographic examination and GLS measurements at baseline, 3 months, and 6 months. ARNI therapy resulted in a significant reduction of ventricular volumes and a significant increase in left ventricular ejection fraction at 6 months but not 3 months by standard transthoracic echocardiography (left ventricular ejection fraction from 28 ± 8% at baseline to 34 ± 12% at 6 months, P < 0.001). Non-significant differences in the size of the left atrium, right ventricular function, and pulmonary pressures were found at 6 months. By using GLS, there was a progressive improvement of all strain parameters by 3 months. The improvement showed a progressive trend over time and maintained significance at 6 months: GLS 4ch -7.2 ± 4.8% at baseline vs. -7.5 ± 3.9% at 3 months (P = 0.025) and - 9.2 ± 5.2% at 6 months (P = 0.0001); AVG GLS -6.9 ± 4.3 at baseline vs. -7.9 ± 4.2 at 3 months (P = 0.04) and - 8.8 ± 4.4 at 6 months (P = 0.035); GLS endo 8.2 ± 4.8 at baseline vs. -9.0 ± 4.8 at 3 months (P = 0.05) and - 10.1 ± 5.1 at 6 months (P = 0.001).
CONCLUSIONS
Sacubitril/valsartan induces an early benefit on left ventricular remodelling, which is captured by myocardial strain and not by standard echocardiography. Strain method represents a practical tool to assess early and minimal variations of left ventricular systolic function.",2020,"ARNI therapy resulted in a significant reduction of ventricular volumes and a significant increase in left ventricular ejection fraction at 6 months but not 3 months by standard transthoracic echocardiography (left ventricular ejection fraction from 28 ± 8% at baseline to 34 ± 12% at 6 months, P ","['patients with heart failure and reduced ejection fraction (HFrEF', 'patients with heart failure treated with', 'Thirty patients with New York Heart Association class II-III HFrEF were treated with', 'patients with HFrEF', 'patients with HFrEF undergoing ARNI therapy, using standard transthoracic echocardiography']","['ARNI', 'ARNI and monitored using standard echocardiographic examination and GLS measurements', 'sacubitril/valsartan', 'Sacubitril/valsartan', 'angiotensin receptor neprilysin inhibitor (ARNI']","['ventricular volumes', 'left ventricular ejection fraction', 'mortality and hospitalizations', 'size of the left atrium, right ventricular function, and pulmonary pressures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}]","[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0376784', 'cui_str': 'Atrium (drug)'}, {'cui': 'C0080311', 'cui_str': 'Ventricular Function, Right'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",30.0,0.0246605,"ARNI therapy resulted in a significant reduction of ventricular volumes and a significant increase in left ventricular ejection fraction at 6 months but not 3 months by standard transthoracic echocardiography (left ventricular ejection fraction from 28 ± 8% at baseline to 34 ± 12% at 6 months, P ","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Mazzetti', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Scifo', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Abete', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Margonato', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Chioffi', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rossi', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pisani', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Passafaro', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Grillo', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Poggio', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mortara', 'Affiliation': 'Department of Clinical Cardiology, Policlinico di Monza, Via Amati, 111, 20900, Monza, MB, Italy.'}]",ESC heart failure,['10.1002/ehf2.12656']
573,32229186,Ten-year disease progression and mortality rates in men who experience biochemical recurrence versus persistence after radical prostatectomy and undergo salvage radiation therapy: A post-hoc analysis of RTOG 9601 trial data.,"PURPOSE
To compare local/metastatic disease progression and overall mortality rates in men with node-negative prostate cancer at radical prostatectomy (RP) that experience biochemical recurrence vs. persistence postoperatively and undergo salvage radiation therapy (sRT).
MATERIALS AND METHODS
Data on 760 men who participated in the RTOG 9601 trial were extracted using the NCTN data archive platform. Patients were stratified into biochemical recurrence (nadir-PSA ≤0.4 ng/ml) or persistence (nadir-PSA >0.4 ng/ml) groups, based on the cut-off reported in the original trial. Inverse probability of treatment weighting (IPTW) methodology was utilized to minimize the baseline differences among groups. Competing-risk and Kaplan-Meier analyses estimated the impact of prostate-specific antigen (PSA) persistence vs. recurrence on local and metastatic disease progression and overall-mortality in the IPTW-adjusted model; a 2-sided P < 0.05 was considered significant.
RESULTS
All patients received sRT, and about 50% of the patients in either group received concomitant antiandrogen therapy (P = 0.951). The median follow-up was 12 years. After IPTW, the 2 groups were well-matched with standardized mean differences ∼10%. In the IPTW-adjusted cohort, the 10-year local and metastatic disease occurrence rates were 3.2% vs. 1.4% (Gray's P = 0.0001) and 28.6% vs. 10.1% (Gray's P < 0.0001) in patients with persistent vs. recurrent PSA, respectively. Similarly, the 10-year overall-mortality rates were 24.9% vs. 11.9% (Log-rank P = 0.029), respectively.
CONCLUSIONS
Patients with biochemical persistence after RP are approximately 2.5 times more likely to experience local/metastatic failure and death, compared to patients with biochemical recurrence after RP, despite equivalent sRT with/without antiandrogen therapy use. These data may facilitate patient counseling and shared treatment selection.",2020,"CONCLUSIONS
Patients with biochemical persistence after RP are approximately 2.5 times more likely to experience local/metastatic failure and death, compared to patients with biochemical recurrence after RP, despite equivalent sRT with/without antiandrogen therapy use.","['Data on 760 men who participated in the RTOG 9601 trial were extracted using the NCTN data archive platform', 'men with node-negative prostate cancer at']","['salvage radiation therapy (sRT', 'concomitant antiandrogen therapy', 'radical prostatectomy and undergo salvage radiation therapy', 'radical prostatectomy (RP']","['10-year local and metastatic disease occurrence rates', 'mortality rates', '10-year overall-mortality rates', 'prostate-specific antigen (PSA) persistence vs. recurrence on local and metastatic disease progression and overall-mortality', 'overall mortality rates']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0003738'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.133824,"CONCLUSIONS
Patients with biochemical persistence after RP are approximately 2.5 times more likely to experience local/metastatic failure and death, compared to patients with biochemical recurrence after RP, despite equivalent sRT with/without antiandrogen therapy use.","[{'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI. Electronic address: asood1@hfhs.org.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Keeley', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Palma-Zamora', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Deepansh', 'Initials': 'D', 'LastName': 'Dalela', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Olson', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Hanna', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cotter', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Wooju', 'Initials': 'W', 'LastName': 'Jeong', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elshaikh', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Rogers', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Peabody', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Menon', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Abdollah', 'Affiliation': 'VCORE - Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation, Henry Ford Hospital, Detroit, MI; Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI.'}]",Urologic oncology,['10.1016/j.urolonc.2020.02.024']
574,25922328,A cluster-randomised controlled trial to test the efficacy of facemasks in preventing respiratory viral infection among Hajj pilgrims.,"BACKGROUND
Cost-effective interventions are needed to control the transmission of viral respiratory tract infections (RTIs) in mass gatherings. Facemasks are a promising preventive measure, however, previous studies on the efficacy of facemasks have been inconclusive. This study proposes a large-scale facemask trial during the Hajj pilgrimage in Saudi Arabia and presents this protocol to illustrate its feasibility and to promote both collaboration with other research groups and additional relevant studies.
METHODS/DESIGN
A cluster-randomised controlled trial is being conducted to test the efficacy of standard facemasks in preventing symptomatic and proven viral RTIs among pilgrims during the Hajj season in Mina, Mecca, Saudi Arabia. The trial will compare the 'supervised use of facemasks' versus 'standard measures' among pilgrims over several Hajj seasons. Cluster-randomisation will be done by accommodation tents with a 1:1 ratio. For the intervention tents, free facemasks will be provided to be worn consistently for 7days. Data on flu-like symptoms and mask use will be recorded in diaries. Nasal samples will be collected from symptomatic recruits and tested for nucleic acid of respiratory viruses. Data obtained from questionnaires, diaries and laboratory tests will be analysed to examine whether mask use significantly reduces the frequency of laboratory-confirmed respiratory viral infection and syndromic RTI as primary outcomes.
CONCLUSIONS
This trial will provide valuable evidence on the efficacy of standard facemask use in preventing viral respiratory tract infections at mass gatherings. This study is registered at the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12613001018707 (http://www.anzctr.org.au).",2015,This trial will provide valuable evidence on the efficacy of standard facemask use in preventing viral respiratory tract infections at mass gatherings.,"['pilgrims during the Hajj season in Mina, Mecca, Saudi Arabia', 'Hajj pilgrimage in Saudi Arabia', 'Hajj pilgrims']",[],[],"[{'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0036243', 'cui_str': 'Kingdom of Saudi Arabia'}]",[],[],,0.103017,This trial will provide valuable evidence on the efficacy of standard facemask use in preventing viral respiratory tract infections at mass gatherings.,"[{'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.""}, {'ForeName': 'Osamah', 'Initials': 'O', 'LastName': 'Barasheed', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia. Electronic address: osamah.barasheed@health.nsw.gov.au.""}, {'ForeName': 'Harunor', 'Initials': 'H', 'LastName': 'Rashid', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Booy', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Australia.""}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'El Bashir', 'Affiliation': 'Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Haworth', 'Affiliation': 'Menzies Research Institute Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Ridda', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.""}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Holmes', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Dominic E', 'Initials': 'DE', 'LastName': 'Dwyer', 'Affiliation': 'Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Australia; Centre for Infectious Diseases and Microbiology Laboratory Services (CIDMLS), Westmead Hospital, NSW, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Nguyen-Van-Tam', 'Affiliation': 'Division of Epidemiology and Public Health, University of Nottingham (World Health Organization Collaborating Centre for Pandemic Influenza and Research), UK.'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Memish', 'Affiliation': 'Ministry of Health and College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Heron', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.""}]",Journal of epidemiology and global health,['10.1016/j.jegh.2014.08.002']
575,32227774,"Effect of acupressure on postpartum low back pain, salivary cortisol, physical limitations, and depression: a randomized controlled pilot study.","OBJECTIVE
To investigate the effect of acupressure on postpartum low back pain (LBP), salivary cortisol, physical limitations, and postpartum depression.
METHODS
Participants were 70 postpartum women who were randomly assigned to either an intervention (n = 35) or a control (n = 35) group. The intervention group received 10 acupressure sessions (1 session per day, 5 d per week). The control group received 10 sham acupressure sessions. Outcomes were assessed using a visual analogue scale (LBP intensity), salivary cortisol values (LBP biomarker), and Chinese versions of the Roland-Morris Disability Questionnaire (daily activity limitations), Oswestry Disability Index (physical activity limitations), and the Edinburgh Postnatal Depression Scale (postpartum depression).
RESULTS
Participants in the intervention group had significantly lower levels of LBP intensity, daily activity limitations, physical activity limitations, and postpartum depression than those in the control group. There was no significant between-group difference in salivary cortisol.
CONCLUSION
Acupressure may reduce postpartum LBP intensity and limitations in daily and physical activity, and alleviate postpartum depressive symptoms. Acupressure should be offered in postpartum care settings as an alternative treatment for postpartum women with LBP.",2020,"RESULTS
Participants in the intervention group had significantly lower levels of LBP intensity, daily activity limitations, physical activity limitations, and postpartum depression than those in the control group.","['Participants were 70 postpartum women who were randomly assigned to either an intervention (n = 35) or a control (n = 35) group', 'postpartum women with LBP']","['Acupressure', '10 acupressure sessions', 'acupressure', '10 sham acupressure sessions']","['postpartum low back pain, salivary cortisol, physical limitations, and depression', 'postpartum LBP intensity and limitations in daily and physical activity', 'visual analogue scale (LBP intensity), salivary cortisol values (LBP biomarker), and Chinese versions of the Roland-Morris Disability Questionnaire (daily activity limitations), Oswestry Disability Index (physical activity limitations), and the Edinburgh Postnatal Depression Scale (postpartum depression', 'LBP intensity, daily activity limitations, physical activity limitations, and postpartum depression', 'salivary cortisol', 'postpartum low back pain (LBP), salivary cortisol, physical limitations, and postpartum depression']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}]",70.0,0.0853547,"RESULTS
Participants in the intervention group had significantly lower levels of LBP intensity, daily activity limitations, physical activity limitations, and postpartum depression than those in the control group.","[{'ForeName': 'Hsuesh-Yu', 'Initials': 'HY', 'LastName': 'Cheng', 'Affiliation': 'Department of Nursing, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 80830, Taiwan China.'}, {'ForeName': 'Shieh', 'Initials': 'S', 'LastName': 'Carol', 'Affiliation': 'Department of Community and Health Systems, Indiana University School of Nursing, Indiana 600, USA.'}, {'ForeName': 'BeiYu', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 80830, Taiwan China.'}, {'ForeName': 'Yu-Fen', 'Initials': 'YF', 'LastName': 'Cheng', 'Affiliation': 'Department of Nursing, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 80830, Taiwan China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
576,30942842,Effect of a Multifaceted Quality Improvement Intervention on the Prescription of Evidence-Based Treatment in Patients at High Cardiovascular Risk in Brazil: The BRIDGE Cardiovascular Prevention Cluster Randomized Clinical Trial.,"Importance
Studies have found that patients at high cardiovascular risk often fail to receive evidence-based therapies in community practice.
Objective
To evaluate whether a multifaceted quality improvement intervention can improve the prescription of evidence-based therapies.
Design, Setting, and Participants
In this 2-arm cluster randomized clinical trial, patients with established atherothrombotic disease from 40 public and private outpatient clinics (clusters) in Brazil were studied. Patients were recruited from August 2016 to August 2017, with follow-up to August 2018. Data were analyzed in September 2018.
Interventions
Case management, audit and feedback reports, and distribution of educational materials (to health care professionals and patients) vs routine practice.
Main Outcomes and Measures
The primary end point was prescription of evidence-based therapies (ie, statins, antiplatelet therapy, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) using the all-or-none approach at 12 months after the intervention period in patients without contraindications.
Results
Of the 1619 included patients, 1029 (63.6%) were male, 1327 (82.0%) had coronary artery disease (843 [52.1%] with prior acute myocardial infarction), 355 (21.9%) had prior ischemic stroke or transient ischemic attack, and 197 (12.2%) had peripheral vascular disease, and the mean (SD) age was 65.6 (10.5) years. Among randomized clusters, 30 (75%) were cardiology sites, 6 (15%) were primary care units, and 26 (65%) were teaching institutions. Among eligible patients, those in intervention clusters were more likely to receive a prescription of evidence-based therapies than those in control clusters (73.5% [515 of 701] vs 58.7% [493 of 840]; odds ratio, 2.30; 95% CI, 1.14-4.65). There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes). Rates of education for smoking cessation were higher among current smokers in the intervention group than in the control group (51.9% [364 of 701] vs 18.2% [153 of 840]; odds ratio, 11.24; 95% CI, 2.20-57.43). The rate of cardiovascular mortality, acute myocardial infarction, and stroke was 2.6% for patients from intervention clusters and 3.4% for those in the control group (hazard ratio, 0.76; 95% CI, 0.43-1.34).
Conclusions and Relevance
Among Brazilian patients at high cardiovascular risk, a quality improvement intervention resulted in improved prescription of evidence-based therapies.
Trial Registration
ClinicalTrials.gov identifier: NCT02851732.",2019,"There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes).","['Patients at High Cardiovascular Risk in Brazil', '1619 included patients, 1029 (63.6%) were male, 1327 (82.0%) had coronary artery disease (843 [52.1%] with prior acute myocardial infarction), 355 (21.9%) had prior ischemic stroke or transient ischemic attack, and 197 (12.2%) had peripheral vascular disease, and the mean (SD) age was 65.6 (10.5) years', 'Patients were recruited from August 2016 to August 2017, with follow-up to August 2018', 'Brazilian patients at high cardiovascular risk', 'patients with established atherothrombotic disease from 40 public and private outpatient clinics (clusters) in Brazil were studied']","['Multifaceted Quality Improvement Intervention', 'multifaceted quality improvement intervention']","['Rates of education for smoking cessation', 'rate of cardiovascular mortality, acute myocardial infarction, and stroke', 'risk factor control (ie, hyperlipidemia, hypertension, or diabetes', 'prescription of evidence-based therapies (ie, statins, antiplatelet therapy, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0085096', 'cui_str': 'Peripheral Angiopathies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}]",,0.173161,"There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes).","[{'ForeName': 'M Julia', 'Initials': 'MJ', 'LastName': 'Machline-Carrion', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rafael Marques', 'Initials': 'RM', 'LastName': 'Soares', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Viviane Bezerra', 'Initials': 'VB', 'LastName': 'Campos', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Sampaio', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Francisco H', 'Initials': 'FH', 'LastName': 'Fonseca', 'Affiliation': 'Federal University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Izar', 'Affiliation': 'Federal University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Amodeo', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Octávio Marques', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana Yamashita', 'Initials': 'JY', 'LastName': 'Santos', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Samara Pinheiro do Carmo', 'Initials': 'SPDC', 'LastName': 'Gomes', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Francisco Kerr', 'Initials': 'JFK', 'LastName': 'Saraiva', 'Affiliation': 'Hospital e Maternidade Celso Pierro, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ramacciotti', 'Affiliation': 'Hospital e Maternidade Christóvão da Gama, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Pedro Gabriel de Melo', 'Initials': 'PGM', 'LastName': 'Barros E Silva', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nilton', 'Initials': 'N', 'LastName': 'Brandão da Silva', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Hélio Penna', 'Initials': 'HP', 'LastName': 'Guimarães', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Piegas', 'Affiliation': 'Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Airton T', 'Initials': 'AT', 'LastName': 'Stein', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Otávio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.0649']
577,32014806,Picking up the Pace: Decreasing Platelet Administration Safely and Effectively.,"BACKGROUND
Hematology-oncology patients often require blood and blood product transfusions, including platelets (PLTs), to maintain stability. Administering PLTs in a shorter timeframe may prove beneficial by possibly raising platelet counts to a higher level faster, and allowing patients to be disconnected from IV pumps sooner.
OBJECTIVE
To evaluate the optimal (safe and effective) transfusion time by comparing standard administration of PLTs over 2-4 h to the investigational administration of PLTs over 30-45 min in the pediatric hematology-oncology inpatient population.
METHODOLOGY
A pilot trial was conducted using a convenience sample of hematology-oncology children. Children prescribed a PLT transfusion while admitted to an inpatient unit were eligible. If randomized to the intervention group, the nurse administered the PLTs over 30-45 min. If randomized to the standard group, the nurse administered the PLTs over 2-4 h. Post transfusion PLTcount was drawn 30 min after completion. The child was monitored closely for adverse reactions.
RESULTS
Eleven participants were enrolled in the study and 20 PLT infusions administered. No adverse events were noted. There was not a significant difference in changes in PLT counts by group (post minus pre), p = 0.082. There was not a significant difference in post infusion PLT counts, p = 0.727. There was a significant difference in the rate of change in PLT counts by groups, p = 0.003.
NURSING IMPLICATIONS
This pilot study provides preliminary evidence that PLTs may be safely and effectively administered over 30-45 min in pediatric hematology-oncology patients. With quicker PLT administration, patients can be disconnected from IV pumps sooner.",2020,"There was a significant difference in the rate of change in PLT counts by groups, p = 0.003.
","['pediatric hematology-oncology patients', 'PLTs over 30-45\xa0min in the pediatric hematology-oncology inpatient population', 'Children prescribed a PLT transfusion while admitted to an inpatient unit were eligible', 'Eleven participants were enrolled in the study and 20 PLT infusions administered', 'convenience sample of hematology-oncology children']",['PLTs'],"['PLT counts', 'optimal (safe and effective) transfusion time', 'post infusion PLT counts', 'adverse events', 'rate of change in PLT counts']","[{'cui': 'C1690538', 'cui_str': 'Pediatric hematology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}]","[{'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}]","[{'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",11.0,0.0523126,"There was a significant difference in the rate of change in PLT counts by groups, p = 0.003.
","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Steck', 'Affiliation': 'University of Virginia Medical Center, Charlottesville, VA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller-Davis', 'Affiliation': 'University of Virginia Medical Center, Charlottesville, VA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conaway', 'Affiliation': 'University of Virginia School of Medicine, VA, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Quatrara', 'Affiliation': 'University of Virginia School of Nursing, VA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Letzkus', 'Affiliation': 'University of Virginia Medical Center, Charlottesville, VA, USA; University of Virginia School of Nursing, VA, USA. Electronic address: lmc8c@virginia.edu.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.01.014']
578,31397726,A cluster randomized controlled trial to evaluate a resilience-based intervention for caregivers of HIV-affected children in China.,"OBJECTIVES
The Child-Caregiver-Advocacy Resilience (ChildCARE) intervention aims to enhance the psychosocial wellbeing of children affected by parental HIV by providing programing at three levels: child, caregiver, and community. The objective of the current study was to evaluate the intervention's efficacy in improving mental health and parenting outcomes for participating caregivers.
DESIGN
A cluster randomized controlled trial was used to evaluate initial efficacy of the intervention.
METHODS
A total of 790 caregivers of children affected by parental HIV were recruited from Henan, China. Caregivers and their children were randomly assigned to one-of-four intervention arms (control, child-only, child + caregiver, child + caregiver + community) to evaluate the multiple components of ChildCARE. Those assigned to receive the caregiver intervention participated in five 2-h intervention sessions designed to improve their parenting skills and enhance their ability to cope with daily stressors. Caregivers reported on their mental health and parenting behaviors at baseline, 12, 24, and 36 months, with mixed effect modeling used to examine intervention effects.
RESULTS
Caregivers who participated in the intervention reported decreased anxiety and parental stress at 12 months (P < 0.05). Participants also reported increased use of structured parenting skills (i.e., parental demandingness) at 12 and 24 months (P < 0.05). However, by 36 months, they reported significantly lower levels of parental competence (P < 0.01) than those assigned to the control condition.
CONCLUSION
Preliminary findings suggest that the caregiving component of ChildCARE yields initial improvements in some key parenting and mental health outcomes. However, the challenges of caring for children affected by HIV are complex and may require more intensive intervention to yield marked, positive changes across key caregiver outcomes.",2019,"RESULTS
Caregivers who participated in the intervention reported decreased anxiety and parental stress at 12 months (P < 0.05).","['participating caregivers', 'caregivers of HIV-affected children in China', '790 caregivers of children affected by parental HIV were recruited from Henan, China', 'Caregivers and their children', 'children affected by parental HIV by providing programing at three levels: child, caregiver, and community']","['Child-Caregiver-Advocacy Resilience (ChildCARE) intervention', 'resilience-based intervention', 'caregiver intervention participated in five 2-h intervention sessions designed to improve their parenting skills', 'four intervention arms (control, child-only, child\u200a+\u200acaregiver, child\u200a+\u200acaregiver\u200a+\u200acommunity']","['anxiety and parental stress', 'mental health and parenting behaviors', 'structured parenting skills', 'levels of parental competence', 'mental health and parenting outcomes']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",790.0,0.115828,"RESULTS
Caregivers who participated in the intervention reported decreased anxiety and parental stress at 12 months (P < 0.05).","[{'ForeName': 'Sayward E', 'Initials': 'SE', 'LastName': 'Harrison', 'Affiliation': 'Department of Health Promotion, Education, and Behavior.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Health Promotion, Education, and Behavior.'}, {'ForeName': 'JiaJia', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'International Research Center for Physical and Psychological Health of Vulnerable Populations, College of Educational Sciences, Henan University, Kaifeng.'}, {'ForeName': 'Guoxiang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychology, Henan Normal University, Xinxiang, Henan, China.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002181']
579,32239448,Relaxation training significantly reduced blood glucose levels in patients with type 1 diabetes mellitus.,"PURPOSE/OBJECTIVE
The present study was designed to test whether adding a relaxation training technique to the medical treatment of patients with type 1 diabetes mellitus could, adjusting for the non-specific factors of therapy, lead to an improvement in the patients' condition.
METHOD
Forty-six participants were randomly allocated either to an experimental (intervention) group, receiving weekly sessions of relaxation training, or to a control group (placebo) receiving weekly blood circulation training exercises. Measures included the State and Trait Anxiety Inventory, blood glucose levels, high-density lipoprotein levels, cholesterol levels, body weight, HbA1c levels, the Mood Adjective Checklist (MACL), a diary checklist, and urine glucose levels. Assessment of psychological and physiological parameters was conducted before and upon completion of the intervention (8 weeks).
RESULTS
Trait anxiety and the main metabolic measurement of blood glucose levels and HbA1C revealed significant differences over time, predominantly among patients in the intervention group.
CONCLUSIONS
Relaxation techniques as an adjunct to medical treatment are a useful tool for patients with type 1 diabetes mellitus.",2020,"RESULTS
Trait anxiety and the main metabolic measurement of blood glucose levels and HbA1C revealed significant differences over time, predominantly among patients in the intervention group.
","['Forty-six participants', 'patients with type 1 diabetes mellitus']","['Relaxation training', 'relaxation training technique', 'relaxation training, or to a control group (placebo) receiving weekly blood circulation training exercises']","['Trait anxiety and the main metabolic measurement of blood glucose levels', 'State and Trait Anxiety Inventory, blood glucose levels, high-density lipoprotein levels, cholesterol levels, body weight, HbA1c levels, the Mood Adjective Checklist (MACL), a diary checklist, and urine glucose levels', 'blood glucose levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0451315', 'cui_str': 'Mood adjective checklist'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0004076', 'cui_str': 'Glucose measurement, urine'}]",46.0,0.0116609,"RESULTS
Trait anxiety and the main metabolic measurement of blood glucose levels and HbA1C revealed significant differences over time, predominantly among patients in the intervention group.
","[{'ForeName': 'Antonia A', 'Initials': 'AA', 'LastName': 'Paschali', 'Affiliation': 'Department of Mental Health & Behavioral Sciences, Faculty of Nursing, National & Kapodistrian University of Athens, Athens, Greece. anpascha@nurs.uoa.gr.'}, {'ForeName': 'Lily Εvangelia', 'Initials': 'LΕ', 'LastName': 'Peppou', 'Affiliation': 'Community Mental Health Centre, University Mental Health Research Institute (UMHRI), Athens, Greece.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Benroubi', 'Affiliation': 'Diabetes Centre, General Hospital of Athens Evangelismos-Polikliniki, Athens, Greece.'}]","Hormones (Athens, Greece)",['10.1007/s42000-020-00187-w']
580,32233338,"A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity.","BACKGROUND
Obesity is a chronic disease with limited treatment options in pediatric patients. Liraglutide may be useful for weight management in adolescents with obesity.
METHODS
In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide (3.0 mg) or placebo subcutaneously once daily, in addition to lifestyle therapy. The primary end point was the change from baseline in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) standard-deviation score at week 56.
RESULTS
A total of 125 participants were assigned to the liraglutide group and 126 to the placebo group. Liraglutide was superior to placebo with regard to the change from baseline in the BMI standard-deviation score at week 56 (estimated difference, -0.22; 95% confidence interval [CI], -0.37 to -0.08; P = 0.002). A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%). A greater reduction was observed with liraglutide than with placebo for BMI (estimated difference, -4.64 percentage points) and for body weight (estimated difference, -4.50 kg [for absolute change] and -5.01 percentage points [for relative change]). After discontinuation, a greater increase in the BMI standard-deviation score was observed with liraglutide than with placebo (estimated difference, 0.15; 95% CI, 0.07 to 0.23). More participants in the liraglutide group than in the placebo group had gastrointestinal adverse events (81 of 125 [64.8%] vs. 46 of 126 [36.5%]) and adverse events that led to discontinuation of the trial treatment (13 [10.4%] vs. 0). Few participants in either group had serious adverse events (3 [2.4%] vs. 5 [4.0%]). One suicide, which occurred in the liraglutide group, was assessed by the investigator as unlikely to be related to the trial treatment.
CONCLUSIONS
In adolescents with obesity, the use of liraglutide (3.0 mg) plus lifestyle therapy led to a significantly greater reduction in the BMI standard-deviation score than placebo plus lifestyle therapy. (Funded by Novo Nordisk; NN8022-4180 ClinicalTrials.gov number, NCT02918279.).",2020,"A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%).","['enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone', 'Adolescents with Obesity', 'pediatric patients', 'adolescents with obesity', 'A total of 125 participants']","['Liraglutide', 'liraglutide', 'placebo', 'placebo subcutaneously once daily, in addition to lifestyle therapy']","['body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) standard-deviation score', 'BMI standard-deviation score', 'gastrointestinal adverse events', 'BMI', 'body weight', 'serious adverse events', 'adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",125.0,0.384518,"A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%).","[{'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Kelly', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Auerbach', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Barrientos-Perez', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Gies', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Hale', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Marcus', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Lucy D', 'Initials': 'LD', 'LastName': 'Mastrandrea', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Nandana', 'Initials': 'N', 'LastName': 'Prabhu', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916038']
581,30394541,Examining the nonkin support networks of orphaned adolescents participating in a family-based economic-strengthening intervention in Uganda.,"In this study, we examined the nonkin support networks of orphaned adolescents participating in a family-based economic-strengthening intervention in HIV-impacted communities in Uganda. We analyzed data from a cluster randomized experimental study for orphaned adolescents aged 11-17 years. Participants were randomly assigned to either the control condition, which received bolstered standard of care (BSOC) services, or the treatment condition, which received BSOC services plus an economic-strengthening intervention. We conducted binary logistic regression analyses to examine the effect of the intervention on participants' nonkin support networks. Results indicated that the existing social support networks for orphaned adolescents are small, limited, and usually comprised individuals with similar socioeconomic situations and challenges. Because orphaned adolescents are socially isolated and the threshold for nonkin supportive services is very low, the BSOC services provided to the control condition appeared to be instrumental in their survival and well-being. Availability of personal savings was associated with higher odds of identifying at least one supportive nonkin tie. The extended family system is still the primary and major source of social support to orphaned children in HIV-affected communities. In the absence of public safety nets, building social assets, over and above offering economic opportunities to extended families supporting orphaned children, is critical.",2019,The extended family system is still the primary and major source of social support to orphaned children in HIV-affected communities.,"['orphaned adolescents participating in a family-based economic-strengthening intervention in Uganda', ""participants' nonkin support networks"", 'orphaned adolescents participating in a family-based economic-strengthening intervention in HIV-impacted communities in Uganda', 'orphaned adolescents aged 11-17 years']","['bolstered standard of care (BSOC) services, or the treatment condition, which received BSOC services plus an economic-strengthening intervention']",['Availability of personal savings'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013557', 'cui_str': 'economics'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]",,0.0255059,The extended family system is still the primary and major source of social support to orphaned children in HIV-affected communities.,"[{'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Padgett', 'Affiliation': 'New York University Silver School of Social Work.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Courtney', 'Affiliation': 'The University of Chicago School of Social Service Administration.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Neilands', 'Affiliation': 'University of California San Francisco School of Medicine.'}]",Journal of community psychology,['10.1002/jcop.22139']
582,30702510,Minimal Detectable Change for Gait Speed Depends on Baseline Speed in Individuals With Chronic Stroke.,"BACKGROUND AND PURPOSE
Given the heterogeneity of mobility outcomes after stroke, the purpose of this study was to examine how the minimal detectable change (MDC) for gait speed varies based on an individual's baseline walking speed.
METHODS
Seventy-six participants with chronic stroke and able to walk without therapist assistance participated in 2 visits to record overground self-selected comfortable gait speed (CGS) and fast gait speed (FGS). Based on the CGS at visit 1, participants were assigned to 1 of 3 speed groups: low (<0.4 m/s; n = 32), moderate (0.4-0.8 m/s; n = 29), and high functioning group (>0.8 m/s; n = 15). Participants were then reclassified using updated gait speed cutoffs of 0.49 and 0.93 m/s. For each group, we determined test-retest reliability between visits, and the MDC for CGS and FGS.
RESULTS
Gait speed significantly increased from visit 1 to visit 2 for each group (P < 0.001). The reliability for CGS declined with increasing gait speed, and MDC95 values increased with increasing gait speed (low: 0.10 m/s; moderate: 0.15 m/s; and high: 0.18 m/s). Similar findings were observed for FGS, and when participants were recoded using alternative thresholds.
DISCUSSION AND CONCLUSIONS
Slower walkers demonstrated greater consistency in walking speed from day to day, which contributed to a smaller MDC95 than faster walkers. These data will help researchers and clinicians adjust their expectations and goals when working with individuals with chronic stroke. Expectations for changing gait speed should be based on baseline gait speed, and will allow for more appropriate assessments of intervention outcomes. AVAILABLE: for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A253).",2019,Gait speed significantly increased from visit 1 to visit 2 for each group (P < 0.001).,"['Seventy-six participants with chronic stroke and able to walk without therapist assistance participated in 2', 'Individuals With Chronic Stroke']",['visits to record overground self-selected comfortable gait speed (CGS) and fast gait speed (FGS'],"['gait speed, and MDC95 values', 'Gait speed']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",76.0,0.0223609,Gait speed significantly increased from visit 1 to visit 2 for each group (P < 0.001).,"[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Lewek', 'Affiliation': 'Division of Physical Therapy, Department of Allied Health Sciences, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sykes', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000257']
583,31397288,"Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multicentre, single-blinded, randomised controlled trial.","BACKGROUND
Post-stroke aphasia might improve over many years with speech and language therapy; however speech and language therapy is often less readily available beyond a few months after stroke. We assessed self-managed computerised speech and language therapy (CSLT) as a means of providing more therapy than patients can access through usual care alone.
METHODS
In this pragmatic, superiority, three-arm, individually randomised, single-blind, parallel group trial, patients were recruited from 21 speech and language therapy departments in the UK. Participants were aged 18 years or older and had been diagnosed with aphasia post-stroke at least 4 months before randomisation; they were excluded if they had another premorbid speech and language disorder caused by a neurological deficit other than stroke, required treatment in a language other than English, or if they were currently using computer-based word-finding speech therapy. Participants were randomly assigned (1:1:1) to either 6 months of usual care (usual care group), daily self-managed CSLT plus usual care (CSLT group), or attention control plus usual care (attention control group) with the use of computer-generated stratified blocked randomisation (randomly ordered blocks of sizes three and six, stratified by site and severity of word finding at baseline based on CAT Naming Objects test scores). Only the outcome assessors and trial statistician were masked to the treatment allocation. The speech and language therapists who were doing the outcome assessments were different from those informing participants about which group they were assigned to and from those delivering all interventions. The statistician responsible for generating the randomisation schedule was separate from those doing the analysis. Co-primary outcomes were the change in ability to retrieve personally relevant words in a picture naming test (with 10% mean difference in change considered a priori as clinically meaningful) and the change in functional communication ability measured by masked ratings of video-recorded conversations, with the use of Therapy Outcome Measures (TOMs), between baseline and 6 months after randomisation (with a standardised mean difference in change of 0·45 considered a priori as clinically meaningful). Primary analysis was based on the modified intention-to-treat (mITT) population, which included randomly assigned patients who gave informed consent and excluded those without 6-month outcome measures. Safety analysis included all participants. This trial has been completed and was registered with the ISRCTN, number ISRCTN68798818.
FINDINGS
From Oct 20, 2014, to Aug 18, 2016, 818 patients were assessed for eligibility, of which 278 (34%) participants were randomly assigned (101 [36%] to the usual care group; 97 [35%] to the CSLT group; 80 [29%] to the attention control group). 86 patients in the usual care group, 83 in the CSLT group, and 71 in the attention control group contributed to the mITT. Mean word finding improvements were 1·1% (SD 11·2) in the usual care group, 16·4% (15·3) in the CSLT group, and 2·4% (8·8) in the attention control group. Word finding improvement was 16·2% (95% CI 12·7 to 19·6; p<0·0001) higher in the CSLT group than in the usual care group and was 14·4% (10·8 to 18·1) higher than in the attention control group. Mean changes in TOMs were 0·05 (SD 0·59) in the usual care group (n=84), 0·04 (0·58) in the CSLT group (n=81), and 0·10 (0·61) in the attention control group (n=68); the mean difference in change between the CSLT and usual care groups was -0·03 (-0·21 to 0·14; p=0·709) and between the CSLT and attention control groups was -0·01 (-0·20 to 0·18). The incidence of serious adverse events per year were rare with 0·23 events in the usual care group, 0·11 in the CSLT group, and 0·16 in the attention control group. 40 (89%) of 45 serious adverse events were unrelated to trial activity and the remaining five (11%) of 45 serious adverse events were classified as unlikely to be related to trial activity.
INTERPRETATION
CSLT plus usual care resulted in a clinically significant improvement in personally relevant word finding but did not result in an improvement in conversation. Future studies should explore ways to generalise new vocabulary to conversation for patients with chronic aphasia post-stroke.
FUNDING
National Institute for Health Research, Tavistock Trust for Aphasia.",2019,Word finding improvement was 16·2% (95% CI 12·7 to 19·6; p<0·0001) higher in the CSLT group than in the usual care group and was 14·4% (10·8 to 18·1) higher than in the attention control group.,"['818 patients were assessed for eligibility, of which 278 (34', 'patients with chronic aphasia post-stroke', 'patients were recruited from 21 speech and language therapy departments in the UK', '86 patients in the usual care group, 83 in the CSLT group, and 71 in the attention control group contributed to the mITT', 'From Oct 20, 2014, to Aug 18, 2016', 'Participants were aged 18 years or older and had been diagnosed with aphasia post-stroke at least 4 months before randomisation; they were excluded if they had another premorbid speech and language disorder caused by a neurological deficit other than stroke, required treatment in a language other than English, or if they were currently using computer-based word-finding speech therapy']","['usual care (usual care group), daily self-managed CSLT plus usual care (CSLT group), or attention control plus usual care (attention control group) with the use of computer-generated stratified blocked randomisation', 'usual care or attention control (Big CACTUS', 'self-managed computerised speech and language therapy (CSLT', 'CSLT', 'Self-managed, computerised speech and language therapy', 'CSLT and attention control groups']","['Mean changes in TOMs', 'Mean word finding improvements', 'change in ability to retrieve personally relevant words in a picture naming test', 'conversation', 'functional communication ability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0379152', 'cui_str': 'lethal toxin LT, Clostridium sordellii'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023009', 'cui_str': 'Speech and language disorder (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C0205394', 'cui_str': 'Other (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607943', 'cui_str': 'findings'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0379152', 'cui_str': 'lethal toxin LT, Clostridium sordellii'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0330340', 'cui_str': 'Cactus'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0565998', 'cui_str': 'Communication ability'}]",818.0,0.115065,Word finding improvement was 16·2% (95% CI 12·7 to 19·6; p<0·0001) higher in the CSLT group than in the usual care group and was 14·4% (10·8 to 18·1) higher than in the attention control group.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Palmer', 'Affiliation': 'Deparment of Health Service Research, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Dimairo', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK. Electronic address: c.l.cooper@sheffield.ac.uk.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Enderby', 'Affiliation': 'Deparment of Health Service Research, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Brady', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, The University of Manchester MAHSC, Manchester, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Latimer', 'Affiliation': 'Department of Health Economics and Decision Science, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Julious', 'Affiliation': 'Department of Design, Trials and Statistics, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cross', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abualbishr', 'Initials': 'A', 'LastName': 'Alshreef', 'Affiliation': 'Department of Health Economics and Decision Science, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Deparment of Health Service Research, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bradley', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Witts', 'Affiliation': 'Deparment of Health Service Research, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK; Speech and Language Therapy, Derbyshire Community Health Services NHS Foundation Trust, Chesterfield, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chater', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30192-9']
584,32163845,Using the Engaging Parents in Education for Discharge (ePED) iPad Application to Improve Parent Discharge Experience.,"PURPOSE
The purpose of this study was to evaluate the use of the Engaging Parents in Education for Discharge (ePED) iPad application on parent experiences of hospital discharge teaching and care coordination. Hypotheses were: parents exposed to discharge teaching using ePED will have 1) higher quality of discharge teaching and 2) better care coordination than parents exposed to usual discharge teaching. The secondary purpose examined group differences in the discharge teaching, care coordination, and 30-day readmissions for parents of children with and without a chronic condition.
DESIGN/METHODS
Using a quasi-experimental design, ePED was implemented on one inpatient unit (n = 211) and comparison group (n = 184) from a separate unit at a pediatric academic medical center. Patient experience outcome measures collected on day of discharge included Quality of Discharge Teaching Scale-Delivery (QDTS-D) and care coordination measured by Care Transition Measure (CTM). Thirty-day readmission was abstracted from records.
RESULTS
Parents taught using ePED reported higher QDTS-D scores than parents without ePED (p = .002). No differences in CTM were found between groups. Correlations between QDTS-D and CTM were small for ePED (r = 0.14, p 0.03) and non-ePED (r = 0.29, p < .001) parent groups. CTM was weakly associated with 30-day readmissions in the ePED group.
CONCLUSION
The use of ePED by the discharging nurse enhances parent-reported quality of discharge teaching.
PRACTICE IMPLICATIONS
The ePED app is a theory-based structured conversation guide to engage parents in discharge preparation. Nursing implementation of ePED contributes to optimizing the patient/family healthcare experience.",2020,"RESULTS
Parents taught using ePED reported higher QDTS-D scores than parents without ePED (p = .002).","['Using a quasi-experimental design, ePED was implemented on one inpatient unit (n\xa0=\xa0211) and comparison group (n\xa0=\xa0184) from a separate unit at a pediatric academic medical center', 'Thirty-day readmission was abstracted from records', 'parents of children with and without a chronic condition']","['CTM', 'Engaging Parents in Education for Discharge (ePED) iPad application']","['QDTS-D scores', 'CTM', 'discharge teaching, care coordination, and 30-day readmissions', '30-day readmissions', 'day of discharge included Quality of Discharge Teaching Scale-Delivery (QDTS-D) and care coordination measured by Care Transition Measure (CTM']","[{'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}]",211.0,0.02238,"RESULTS
Parents taught using ePED reported higher QDTS-D scores than parents without ePED (p = .002).","[{'ForeName': 'Stacee M', 'Initials': 'SM', 'LastName': 'Lerret', 'Affiliation': ""Medical College of Wisconsin, Milwaukee, WI, United States of America; Children's Hospital of Wisconsin, Milwaukee, WI, United States of America. Electronic address: slerret@mcw.edu.""}, {'ForeName': 'Norah L', 'Initials': 'NL', 'LastName': 'Johnson', 'Affiliation': ""Children's Hospital of Wisconsin, Milwaukee, WI, United States of America; College of Nursing, Marquette University, Milwaukee, WI, United States of America. Electronic address: norah.johnson@marquette.edu.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Polfuss', 'Affiliation': ""Children's Hospital of Wisconsin, Milwaukee, WI, United States of America; College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, United States of America. Electronic address: MPolfuss@chw.org.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'College of Nursing, Marquette University, Milwaukee, WI, United States of America. Electronic address: marianne.weiss@marquette.edu.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gralton', 'Affiliation': ""Children's Hospital of Wisconsin, Milwaukee, WI, United States of America. Electronic address: KGralton@chw.org.""}, {'ForeName': 'Carol G', 'Initials': 'CG', 'LastName': 'Klingbeil', 'Affiliation': 'College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, United States of America. Electronic address: klingbei@uwm.edu.'}, {'ForeName': 'Cori', 'Initials': 'C', 'LastName': 'Gibson', 'Affiliation': ""Children's Hospital of Wisconsin, Milwaukee, WI, United States of America. Electronic address: cgibson@chw.org.""}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Garnier-Villarreal', 'Affiliation': 'College of Nursing, Marquette University, Milwaukee, WI, United States of America. Electronic address: mauricio.garniervillarreal@marquette.edu.'}, {'ForeName': 'S Iqbal', 'Initials': 'SI', 'LastName': 'Ahamed', 'Affiliation': 'College of Nursing, Marquette University, Milwaukee, WI, United States of America. Electronic address: sheikh.ahamed@marquette.edu.'}, {'ForeName': 'Riddhiman', 'Initials': 'R', 'LastName': 'Adib', 'Affiliation': 'College of Nursing, Marquette University, Milwaukee, WI, United States of America. Electronic address: riddhiman.adib@marquette.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Unteutsch', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, United States of America. Electronic address: runteutsch@mcw.edu.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Pawela', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, United States of America. Electronic address: lpawela@mcw.edu.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'White-Traut', 'Affiliation': ""Children's Hospital of Wisconsin, Milwaukee, WI, United States of America. Electronic address: RWhite-Traut@chw.org.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Sawin', 'Affiliation': ""Children's Hospital of Wisconsin, Milwaukee, WI, United States of America; College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, United States of America. Electronic address: KSawin@chw.org.""}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.02.041']
585,28810394,Adapting evidence-based behavioral weight loss programs for emerging adults: A pilot randomized controlled trial.,"Emerging adults are at high risk of obesity but behavioral weight loss programs do not meet their needs. Emerging adults ( N = 52, age = 22.3 ± 2 years, body mass index = 34.2 ± 5.5 kg/m 2 , 46.2% non-Hispanic White) were randomly assigned to one of three behavioral weight loss programs adapted based on formative work: face-to-face behavioral weight loss, web-based behavioral weight loss, or web plus optional community sessions (Hybrid). Assessments occurred at 0 and 3 months. Engagement and self-monitoring were highest in Hybrid. Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid. Percent achieving ⩾5 percent weight loss was highest in Hybrid (63%). Findings suggest potential for adapted behavioral weight loss to promote engagement and weight loss in emerging adults.",2019,"Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid.","['Emerging adults ( N\u2009=\u200952, age\u2009=\u200922.3\u2009±\u20092\u2009years, body mass index\u2009=\u200934.2\u2009±\u20095.5\u2009kg/m 2 , 46.2% non-Hispanic White', 'emerging adults']","['behavioral weight loss programs adapted based on formative work: face-to-face behavioral weight loss, web-based behavioral weight loss, or web plus optional community sessions (Hybrid']",['weight loss'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0311466,"Intent-to-treat weight losses were -2.8 ± 2.9 percent in face-to-face behavioral weight loss, -2.2 ± 4.5 percent in web-based behavioral weight loss, and 4.8 ± 4.9 percent in Hybrid.","[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': '2 The University of North Carolina at Chapel Hill, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Fava', 'Affiliation': '3 The Miriam Hospital, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': '3 The Miriam Hospital, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Blumenthal', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Caccavale', 'Affiliation': '1 Virginia Commonwealth University, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': '3 The Miriam Hospital, USA.'}]",Journal of health psychology,['10.1177/1359105316688951']
586,32228133,Evaluation of Human Papillomavirus Vaccination After Pharmacist-Led Intervention: A Pilot Project in an Ambulatory Clinic at a Large Academic Urban Medical Center.,"OBJECTIVES
Despite the safety and efficacy of the human papillomavirus (HPV) vaccine, many persons are still not receiving it. The purpose of this pilot project was to evaluate the number of first doses of the 9-valent HPV (9vHPV) vaccination administered after a pharmacist-led intervention in the Adult Family Planning Clinic at Grady Health System (GHS), a large academic urban medical center in Atlanta, Georgia.
METHODS
The pilot project had 3 phases: pre-intervention (November 15, 2016, through March 31, 2017), active intervention (November 15, 2017, through December 29, 2017), and post-intervention (December 30, 2017, through March 31, 2018). The pre-intervention phase was used as a historical control. The active intervention phase consisted of pharmacist interventions in the clinic and patient and health care provider education. The post-intervention phase evaluated the durability of pharmacist-led interventions performed and education provided during the active phase.
RESULTS
Eighty-nine first-dose 9vHPV vaccines (of the 3-dose series) were administered to young adults aged 18-26 during the project period (November 15, 2017, through March 31, 2018); none were administered during the pre-intervention phase. Of 89 patients who received a first 9vHPV vaccine dose, 20 patients also received a second 9vHPV vaccine dose. During the project period, 166 doses of 9vHPV vaccine (first, second, or third doses) were administered.
CONCLUSION
This pharmacist-led intervention led to an increase in the number of young adult patients receiving their first dose of the 9vHPV vaccination series. With the support of other health care providers, pharmacist-led initiatives can expand vaccine-related health literacy and facilitate access to immunization services.",2020,This pharmacist-led intervention led to an increase in the number of young adult patients receiving their first dose of the 9vHPV vaccination series.,"['Adult Family Planning Clinic at Grady Health System (GHS), a large academic urban medical center in Atlanta, Georgia', 'Eighty-nine first-dose 9vHPV vaccines (of the 3-dose series) were administered to young adults aged 18-26 during the project period (November 15, 2017, through March 31, 2018); none were administered during the pre-intervention phase', '89 patients who received a first', 'Human Papillomavirus', 'Ambulatory Clinic at a Large Academic Urban Medical Center']","['9-valent HPV (9vHPV) vaccination', '9vHPV vaccine dose', 'pharmacist interventions', 'human papillomavirus (HPV) vaccine', 'Pharmacist-Led Intervention', '9vHPV vaccine']",['Vaccination'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0352415,This pharmacist-led intervention led to an increase in the number of young adult patients receiving their first dose of the 9vHPV vaccination series.,"[{'ForeName': 'Julianna', 'Initials': 'J', 'LastName': 'Cebollero', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Walton', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Cavendish', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Quairoli', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cwiak', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Kottke', 'Affiliation': '1365 Grady Health System, Atlanta, GA, USA.'}]","Public health reports (Washington, D.C. : 1974)",['10.1177/0033354920914340']
587,31455897,"Body weight, body composition and survival after 1 year: follow-up of a nutritional intervention trial in allo-HSCT recipients.","The role of body weight change in survival among recipients of hematopoietic stem-cell transplantation is controversial. We assessed the effect of optimizing energy and protein intake on 1-year survival, body weight and body composition, and the effect of body weight and body composition on 1-year survival in 117 patients (57 intervention, 60 control) in a randomized controlled trial. Cox regression was used to study effects of the intervention, weight and body composition on death, relapse, and nonrelapse mortality (NRM). We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90). Body weight, fat-free mass index, body fat mass index and total body water changed over time (p < 0.001), similarly in both groups (0.17 ≤ p ≤ 0.98). In multivariable analyses adjusted for group, gender and age, HRs and 95% CIs per one kilo increase in weight were 1.03 (1.01-1.06) and 1.04 (1.01-1.08) for death and NRM after 1 year (p ≤ 0.02), respectively, and 1.08 (1.01-1.15) for relapse after 3 months (p = 0.02). In conclusion, weight gain is possibly due to fluid retention and is an indicator of a complication in HSCT, rather than a marker of improved nutritional status.",2019,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","['allo-HSCT recipients', '117 patients (57 intervention, 60 control', 'recipients of hematopoietic stem-cell transplantation']",['optimizing energy and protein intake'],"['Body weight, body composition and survival', 'relapse', 'weight and body composition on death, relapse, and nonrelapse mortality (NRM', 'weight', 'Body weight, fat-free mass index, body fat mass index and total body water changed over time', 'weight gain', 'death and NRM', 'death hazard ratio', '1-year survival, body weight and body composition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",117.0,0.156154,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Skaarud', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway. kskaarud@ous-hf.no.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Veierød', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lergenmuller', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'European Palliative Care Research Centre, Department of Oncology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}]",Bone marrow transplantation,['10.1038/s41409-019-0638-6']
588,31015198,Phase II Trial of Chemopreventive Effects of Levonorgestrel on Ovarian and Fallopian Tube Epithelium in Women at High Risk for Ovarian Cancer: An NRG Oncology Group/GOG Study.,"A large body of epidemiologic evidence has shown that use of progestin-containing preparations lowers ovarian cancer risk. The purpose of the current study was to gather further preclinical evidence supporting progestins as cancer chemopreventives by demonstrating progestin-activation of surrogate endpoint biomarkers pertinent to cancer prevention in the genital tract of women at increased risk of ovarian cancer. There were 64 women enrolled in a multi-institutional randomized trial who chose to undergo risk-reducing bilateral salpingo-oophorectomy (BSO) and to receive the progestin levonorgestrel or placebo for 4 to 6 weeks prior to undergoing BSO. The ovarian and fallopian tube epithelia (FTE) were compared immunohistochemically for effects of levonorgestrel on apoptosis (primary endpoint). Secondary endpoints included TGFβ isoform expression, proliferation, and karyometric features of nuclear abnormality. In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms. In the ovarian epithelium, treatment with levonorgestrel significantly decreased the proliferation index. The mean ovarian Ki-67 value in the placebo arm was 2.027 per 100 cells versus 0.775 per 100 cells in the levonorgestrel arm (two-sided P value via Mann-Whitney U test = 0.0114). The karyometric signature of nuclei in both the ovarian and FTE deviated significantly from normal controls (women at average risk of ovarian cancer), but was significantly less abnormal in women treated with levonorgestrel. These karyometric data further support the idea that progestins may clear genetically abnormal cells and act as chemopreventive agents against ovarian and fallopian tube cancer.",2019,"In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms.","['Women at High Risk for Ovarian Cancer', '64 women enrolled in a multi-institutional randomized trial who chose to']","['placebo', 'levonorgestrel', 'Levonorgestrel', 'progestin-containing preparations', 'undergo risk-reducing bilateral salpingo-oophorectomy (BSO', 'progestin levonorgestrel or placebo']","['ovarian and fallopian tube epithelia (FTE', 'Ovarian and Fallopian Tube Epithelium', 'proliferation index', 'TGFβ isoform expression, proliferation, and karyometric features of nuclear abnormality', 'mean ovarian Ki-67 value']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}]","[{'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",64.0,0.125864,"In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms.","[{'ForeName': 'Gustavo C', 'Initials': 'GC', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois. grodriguez@northshore.org.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kauderer', 'Affiliation': 'NRG Oncology, Clinical trial Development Division, Biostatistics & Bioinformatics, Roswell Park Cancer Institute; Buffalo, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hunn', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Thaete', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Watkin', 'Affiliation': 'Department of Pathology, NorthShore University Health System, Evanston, Illinois.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Russell', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yozwiak', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Basil', 'Affiliation': 'TriHealth Hospitals, Cincinnati, Ohio.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hurteau', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Shashikant', 'Initials': 'S', 'LastName': 'Lele', 'Affiliation': 'Gynecologic Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Modesitt', 'Affiliation': 'Obstetrics and Gynecology, University of Virginia Health System, Charlottesville, Virginia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Gynecologic Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Hao Helen', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': 'Department of Mathematics, University of Arizona, Department of Mathematics, Phoenix, Arizona.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bartels', 'Affiliation': 'Department of Optical Sciences, University of Arizona, Optical Sciences, Phoenix, Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-18-0383']
589,30650448,"Technology Access, Technical Assistance, and Disparities in Inpatient Portal Use.","BACKGROUND
Disadvantaged populations, including minorities and the elderly, use patient portals less often than relatively more advantaged populations. Limited access to and experience with technology contribute to these disparities. Free access to devices, the Internet, and technical assistance may eliminate disparities in portal use.
OBJECTIVE
To examine predictors of frequent versus infrequent portal use among hospitalized patients who received free access to an iPad, the Internet, and technical assistance.
MATERIALS AND METHODS
This subgroup analysis includes 146 intervention-arm participants from a pragmatic randomized controlled trial of an inpatient portal. The participants received free access to an iPad and inpatient portal while hospitalized on medical and surgical cardiac units, together with hands-on help using them. We used logistic regression to identify characteristics predictive of frequent use.
RESULTS
More technology experience (adjusted odds ratio [OR] = 5.39, p = 0.049), less severe illness (adjusted OR = 2.07, p = 0.077), and private insurance (adjusted OR = 2.25, p = 0.043) predicted frequent use, with a predictive performance (area under the curve) of 65.6%. No significant differences in age, gender, race, ethnicity, level of education, employment status, or patient activation existed between the frequent and infrequent users in bivariate analyses. Significantly more frequent users noticed medical errors during their hospital stay.
DISCUSSION AND CONCLUSION
Portal use was not associated with several sociodemographic characteristics previously found to limit use in the inpatient setting. However, limited technology experience and high illness severity were still barriers to frequent use. Future work should explore additional strategies, such as enrolling health care proxies and improving usability, to reduce potential disparities in portal use.",2019,"RESULTS
More technology experience (adjusted odds ratio [OR] = 5.39, p = 0.049), less severe illness (adjusted OR = 2.07, p = 0.077), and private insurance (adjusted OR = 2.25, p = 0.043) predicted frequent use, with a predictive performance (area under the curve) of 65.6%.","['hospitalized patients who received free access to an iPad, the Internet, and technical assistance']","['free access to an iPad and inpatient portal while hospitalized on medical and surgical cardiac units, together with hands-on help using them']","['private insurance', 'severe illness', 'age, gender, race, ethnicity, level of education, employment status, or patient activation', 'medical errors']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242271', 'cui_str': 'Employment status (observable entity)'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0376531', 'cui_str': 'Medical Mistakes'}]",,0.0320674,"RESULTS
More technology experience (adjusted odds ratio [OR] = 5.39, p = 0.049), less severe illness (adjusted OR = 2.07, p = 0.077), and private insurance (adjusted OR = 2.25, p = 0.043) predicted frequent use, with a predictive performance (area under the curve) of 65.6%.","[{'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Grossman', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, United States.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Masterson Creber', 'Affiliation': 'Department of Healthcare Policy and Research, Weill Cornell Medical College, New York, New York, United States.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Ancker', 'Affiliation': 'Department of Healthcare Policy and Research, Weill Cornell Medical College, New York, New York, United States.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Ryan', 'Affiliation': 'Value Institute, New York-Presbyterian Hospital, New York, New York, United States.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Polubriaginof', 'Affiliation': 'Value Institute, New York-Presbyterian Hospital, New York, New York, United States.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York, United States.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Alarcon', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Restaino', 'Affiliation': 'Department of Medicine, New York-Presbyterian Hospital, New York, New York, United States.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bakken', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, United States.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hripcsak', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, United States.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Vawdrey', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, United States.'}]",Applied clinical informatics,['10.1055/s-0038-1676971']
590,32228379,Acute Exenatide Therapy Attenuates Postprandial Vasodilation in Humans with Prediabetes: A Randomized Controlled Trial.,"Background: The state of prediabetes comprises atherosclerotic changes leading to decreased vascular function in humans. This study examined the effects on incretin mimetics on vascular physiology in the prediabetic postprandial state. Methods: Fifteen obese adults with prediabetes participated in a randomized, crossover, double-blinded trial comparing the postprandial effects of exenatide, saxagliptin, and placebo on peripheral vasodilation. All studies utilized a standardized high-fat meal. Resting and peak forearm blood flow (FBF) were measured via strain gauge venous occlusion plethysmography, and makers of vascular dysfunction were measured in plasma. Results: Exenatide attenuated resting FBF at 3 hr ( P = 0.003) and 6 hr ( P = 0.056) postmeal, compared to placebo. Nonsignificant reductions in resting FBF were observed between saxagliptin and placebo at the same time points. No group differences were observed for peak FBF, plasma nitrotyrosine, and plasma 8-iso-prostaglandin F2alpha. A transient increase in plasma triglyceride was abated in the exenatide group, when compared to saxagliptin and placebo groups. Only exenatide group showed no significant upsurge in plasma insulin. Plasma-free fatty acids significantly declined in all three groups, although less markedly for exenatide. Postmeal glucose increased at 2 hr with placebo and saxagliptin, but simultaneously decreased with exenatide. Conclusions: Acute treatment with exenatide blunted the postprandial vasodilatory effect of a high-fat meal in prediabetes. Exenatide's acute effects derived primarily from multiple endothelium-independent processes. Trial Registration Number: NCT02104739.",2020,"No group differences were observed for peak FBF, plasma nitrotyrosine, and plasma 8-iso-prostaglandin F2alpha.","['Fifteen obese adults with prediabetes participated', 'humans', 'Humans with Prediabetes']","['placebo', 'exenatide', 'placebo and saxagliptin', 'Acute Exenatide Therapy', 'Exenatide', 'saxagliptin and placebo', 'saxagliptin', 'exenatide, saxagliptin, and placebo']","['Plasma-free fatty acids', 'peak FBF, plasma nitrotyrosine, and plasma 8-iso-prostaglandin F2alpha', 'plasma insulin', 'resting FBF', 'Postmeal glucose', 'strain gauge venous occlusion plethysmography, and makers of vascular dysfunction', 'Resting and peak forearm blood flow (FBF', 'Postprandial Vasodilation', 'plasma triglyceride']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0012471', 'cui_str': 'prostaglandin F2 alpha'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0430494', 'cui_str': 'Venous occlusion plethysmography (procedure)'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}]",15.0,0.263025,"No group differences were observed for peak FBF, plasma nitrotyrosine, and plasma 8-iso-prostaglandin F2alpha.","[{'ForeName': 'Vala', 'Initials': 'V', 'LastName': 'Hamidi', 'Affiliation': 'Department of Medicine, Division of Endocrinology, University of California, San Diego, California, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Riggs', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bermudez Saint Andre', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Houston Methodist, Houston, Texas, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Westby', 'Affiliation': 'NASA Johnson Space Center, Houston, Texas, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Coverdale', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Dursteler', 'Affiliation': 'Department of Internal Medicine, University of California Los Angeles-Olive View, Los Angeles, California, USA.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Miller Iii', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Taegtmeyer', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Absalon D', 'Initials': 'AD', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}]",Metabolic syndrome and related disorders,['10.1089/met.2019.0102']
591,32228789,"Effects of Individual and Combined Water, Sanitation, Handwashing, and Nutritional Interventions on Child Respiratory Infections in Rural Kenya: A Cluster-Randomized Controlled Trial.","Poor nutrition and hand hygiene are risk factors for acute respiratory infections (ARIs). Safe drinking water and sanitation can reduce exposure to pathogens and encourage healthy immune responses, reducing the risk of ARIs. Within a trial assessing impacts of water, sanitation, and handwashing (WASH), and nutritional interventions, we evaluated effects on ARIs. The WASH Benefits cluster-randomized trial enrolled pregnant women from Kenyan villages and evaluated health outcomes in children born to enrolled mothers 1 and 2 years after intervention delivery. Geographically adjacent clusters were block-randomized into a passive control (no promotional visits), a double-sized active control (monthly visits to measure mid-upper arm circumference), and six intervention groups: chlorinated drinking water (W), improved sanitation (S), handwashing with soap (H), combined WSH, improved nutrition (N) through counseling and lipid-based nutrient supplementation (LNS), and combined WSHN. The main outcome was the prevalence of ARI symptoms (cough, panting, wheezing, or difficulty breathing) in children younger than 3 years. Masking participants was not possible. Analyses were intention-to-treat. Between November 2012 and May 2014, 702 clusters were enrolled, including 6,960 (year 1) and 7,088 (year 2) children with ARI data. The cluster-level intra-cluster correlation coefficient for ARIs was 0.026 across both years. Water, sanitation, and handwashing interventions with behavior change messaging did not reduce ARIs. Nutrition counseling and LNS modestly reduced ARI symptoms compared with controls in year 1 [prevalence ratio (PR): 0.87, 95% confidence interval (CI): 0.77-0.99], but no effect in the combined WSHN group weakens this finding.",2020,"Safe drinking water and sanitation can reduce exposure to pathogens and encourage healthy immune responses, reducing the risk of ARIs.","['pregnant women from Kenyan villages and evaluated health outcomes in children born to enrolled mothers 1 and 2 years after intervention delivery', 'children younger than 3 years', 'Child Respiratory Infections in Rural Kenya', 'Between November 2012 and May 2014, 702 clusters were enrolled, including 6,960 (year 1) and 7,088 (year 2) children with ARI data']","['passive control (no promotional visits), a double-sized active control (monthly visits to measure mid-upper arm circumference), and six intervention groups: chlorinated drinking water (W), improved sanitation (S), handwashing with soap (H), combined WSH, improved nutrition (N) through counseling and lipid-based nutrient supplementation (LNS), and combined WSHN', 'water, sanitation, and handwashing (WASH), and nutritional interventions', 'Individual and Combined Water, Sanitation, Handwashing, and Nutritional Interventions', 'Nutrition counseling and LNS']","['prevalence of ARI symptoms (cough, panting, wheezing, or difficulty breathing', 'ARI symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0453927', 'cui_str': 'Pants'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.102307,"Safe drinking water and sanitation can reduce exposure to pathogens and encourage healthy immune responses, reducing the risk of ARIs.","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Swarthout', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, Massachusetts.'}, {'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'Epidemiology and Environmental Health, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Holly N', 'Initials': 'HN', 'LastName': 'Dentz', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kalungu', 'Affiliation': 'Innovations for Poverty Action, Nairobi, Kenya.'}, {'ForeName': 'Audrie', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Sammy M', 'Initials': 'SM', 'LastName': 'Njenga', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Null', 'Affiliation': 'Center for International Policy Research and Evaluation, Mathematica Policy Research, Washington, District of Columbia.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, Massachusetts.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0779']
592,30021076,A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest.,"BACKGROUND
Concern about the use of epinephrine as a treatment for out-of-hospital cardiac arrest led the International Liaison Committee on Resuscitation to call for a placebo-controlled trial to determine whether the use of epinephrine is safe and effective in such patients.
METHODS
In a randomized, double-blind trial involving 8014 patients with out-of-hospital cardiac arrest in the United Kingdom, paramedics at five National Health Service ambulance services administered either parenteral epinephrine (4015 patients) or saline placebo (3999 patients), along with standard care. The primary outcome was the rate of survival at 30 days. Secondary outcomes included the rate of survival until hospital discharge with a favorable neurologic outcome, as indicated by a score of 3 or less on the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]).
RESULTS
At 30 days, 130 patients (3.2%) in the epinephrine group and 94 (2.4%) in the placebo group were alive (unadjusted odds ratio for survival, 1.39; 95% confidence interval [CI], 1.06 to 1.82; P=0.02). There was no evidence of a significant difference in the proportion of patients who survived until hospital discharge with a favorable neurologic outcome (87 of 4007 patients [2.2%] vs. 74 of 3994 patients [1.9%]; unadjusted odds ratio, 1.18; 95% CI, 0.86 to 1.61). At the time of hospital discharge, severe neurologic impairment (a score of 4 or 5 on the modified Rankin scale) had occurred in more of the survivors in the epinephrine group than in the placebo group (39 of 126 patients [31.0%] vs. 16 of 90 patients [17.8%]).
CONCLUSIONS
In adults with out-of-hospital cardiac arrest, the use of epinephrine resulted in a significantly higher rate of 30-day survival than the use of placebo, but there was no significant between-group difference in the rate of a favorable neurologic outcome because more survivors had severe neurologic impairment in the epinephrine group. (Funded by the U.K. National Institute for Health Research and others; Current Controlled Trials number, ISRCTN73485024 .).",2018,"There was no evidence of a significant difference in the proportion of patients who survived until hospital discharge with a favorable neurologic outcome (87 of 4007 patients [2.2%] vs. 74 of 3994 patients [1.9%]; unadjusted odds ratio, 1.18; 95% CI, 0.86 to 1.61).","['8014 patients with out-of-hospital cardiac arrest in the United Kingdom, paramedics at five National Health Service ambulance services administered either']","['Epinephrine', 'epinephrine', 'placebo', 'parenteral epinephrine (4015 patients) or saline placebo']","['rate of survival', 'rate of survival until hospital discharge with a favorable neurologic outcome, as indicated by a score of 3 or less on the modified Rankin scale', 'proportion of patients who survived until hospital discharge with a favorable neurologic outcome', 'time of hospital discharge, severe neurologic impairment', 'severe neurologic impairment', 'rate of 30-day survival', 'rate of a favorable neurologic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0030450', 'cui_str': 'Paramedics'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",8014.0,0.663165,"There was no evidence of a significant difference in the proportion of patients who survived until hospital discharge with a favorable neurologic outcome (87 of 4007 patients [2.2%] vs. 74 of 3994 patients [1.9%]; unadjusted odds ratio, 1.18; 95% CI, 0.86 to 1.61).","[{'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Deakin', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Scomparin', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Slowther', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pocock', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'John J M', 'Initials': 'JJM', 'LastName': 'Black', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Fionna', 'Initials': 'F', 'LastName': 'Moore', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Rachael T', 'Initials': 'RT', 'LastName': 'Fothergill', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rees', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': ""O'Shea"", 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Docherty', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Gunson', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Kyee', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Charlton', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Finn', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': ""From the Warwick Clinical Trials Unit (G.D.P., C.J., C.S., S.R., J.L., S.P., S.G., R.L.) and Warwick Medical School (A.S., N.S.), University of Warwick, Coventry, University Hospitals Birmingham (G.D.P.) and the Cancer Research U.K. Clinical Trials Unit, University of Birmingham (S.G.), Birmingham, South Central Ambulance Service NHS Foundation Trust, Otterbourne (C.D.D., H.P., J.J.M.B.), Southampton Respiratory Biomedical Research Unit, National Institute for Health Research, Southampton (C.D.D.), Kingston University and St. George's, University of London (T.Q.), and the London Ambulance Service NHS Trust, (F.M., R.T.F.), London, Bristol Medical School, University of Bristol, Bristol, and Royal United Hospital, Bath (J.P.N.), Oxford University Hospitals NHS Foundation Trust, Oxford (J.J.M.B), South East Coast Ambulance Service, Crawley (F.M.), Welsh Ambulance Services NHS Trust, Swansea (N.R., L.O.), West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill (M.D., I.G.), and North East Ambulance Service NHS Foundation Trust, Newcastle Upon Tyne (K.H., K.C.) - all in the United Kingdom; and Curtin University, Perth, WA (J.F.), and Monash University, Melbourne, VIC (J.F.) - both in Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1806842']
593,32221490,ART with high viscosity GIC and composite restorations in class II cavities: can they thrive in the post-amalgam era?,"Design This study is a parallel group randomised un-blinded trial with equal allocation to evaluate and compare the success of ART with HVGIC and composite restorations in class II cavities in permanent molars. Study population The study populations included 154 participants who were selected from 17 different schools of Bauru and adjoining areas in Sao Paulo, Brazil. Children with good general and oral health and having 1 or 2 class II cavities were chosen. Only one restoration per child which exhibited good occlusal contact was finally chosen for the purpose of study. The participants were then stratified as per DMFT-score and cavity size. After stratifying the participants in four conglomerates, they were randomly allocated to either ART with HVGIC or composite restoration group. Later, the participants were recalled at 6 and 12 months and the restorations were evaluated using ART and modified-USPHS criteria. Data analysis Frequency statistics, which included chi square, chi square for trend and Fisher's exact test, were used for determining the association between restoration type and different baseline variables and for determining the association between distribution of scores obtained with ART and composite restorations for different evaluation criteria. Results With ART criteria, success rates of ART and composite restoration were found to be 98.7% and 100% at 6 months while at 12 months the success rates were observed to be 98.7% and 95.8%, respectively. The distribution of scores at both the time periods was found to be statistically significant (p = 0.033). Same success rates were observed when the restorations were evaluated using modified-USPHS criteria, with statistical difference at the 6 month post-operative recall (p = 0.001), and non-significant difference at the 12 month recall visit (p = 0.310). Survival rates of ART and composite restoration were observed to be 94.8% and 98.7% with no-significant difference in the survival curves (p = 0.173)Conclusions In class II cavities in permanent molars, ART restorations with high viscosity GIC, done in a school setting exhibited similar success rates as composite restoration done in a clinical setting.",2020,The distribution of scores at both the time periods was found to be statistically significant (p = 0.033).,"['class II cavities in permanent molars', 'Study population The study populations included 154 participants who were selected from 17 different schools of Bauru and adjoining areas in Sao Paulo, Brazil', 'Children with good general and oral health and having 1 or 2 class II cavities were chosen', 'class II cavities']",['ART with HVGIC or composite restoration group'],"['Survival rates of ART and composite restoration', 'success rates of ART and composite restoration', 'survival curves', 'Same success rates', 'success rates']","[{'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0029162'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",154.0,0.0934285,The distribution of scores at both the time periods was found to be statistically significant (p = 0.033).,"[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Gugnani', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DAV (C) Dental College, Yamunanagar, Haryana, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gugnani', 'Affiliation': 'Department of Periodontics and Oral Implantology, DAV (C) Dental College Yamunanagar, Haryana, India.'}]",Evidence-based dentistry,['10.1038/s41432-020-0078-6']
594,32221496,Improving orthodontic patients' and parents' information recall with use of audio-visual presentation and mind mapping exercises.,"Design Randomised controlled trial, with blinding of operators and outcome assessors.Study population English-speaking patients aged 10 or older and parents with capacity to consent were given a 45-minute audio-visual presentation and written information on orthodontic treatment in one of three formats, either leaflets from British Orthodontic Society, generic mind map or blank mind maps.Data analysis A 30-item closed-ended questionnaire was used to test knowledge of patients and parents before (T0), at 30 minutes (T1) and 6 weeks (T2) after provision of presentation and written information. Questionnaire scores at T0, T1 and T2 were analysed using box plot, histogram and Shapiro-Wilk test.Results Ninety-three patients and 89 parents were eligible for the study, of which 88 patients (94.6%) and 77 parents (86.5%) have completed questionnaires at T0, T1 and T2. There were no significant differences in scores at T0 between the three groups. After presentation and written information were given, all three participant groups scored higher at T1 and T2. The increase in score was higher in mind map groups.Conclusions Use of audio-visual presentation and written information has improved information recall of patients and parents. The study suggests that mind maps are a superior format of written information than leaflets.",2020,There were no significant differences in scores at T0 between the three groups.,"['patients and parents', 'Study population English-speaking patients aged 10 or older and parents with capacity to consent', 'Results Ninety-three patients and 89 parents were eligible for the study, of which 88 patients (94.6%) and 77 parents (86.5%) have completed questionnaires at T0, T1 and T2']","['audio-visual presentation and mind mapping exercises', '45-minute audio-visual presentation and written information on orthodontic treatment in one of three formats, either leaflets from British Orthodontic Society, generic mind map or blank mind maps']",['Questionnaire scores'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0024779', 'cui_str': 'Map'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",93.0,0.0333612,There were no significant differences in scores at T0 between the three groups.,"[{'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur Gakhal', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Ohsun', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}]",Evidence-based dentistry,['10.1038/s41432-020-0073-y']
595,31615919,Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients.,"OBJECTIVE
To compare the efficacy of secukinumab with that of placebo across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and Outcome Measures in Rheumatology (GRAPPA-OMERACT) individual psoriatic arthritis (PsA) core domains using pooled data from 4 phase III PsA studies and 1 phase III ankylosing spondylitis (AS) study.
METHODS
Data were pooled from 2049 patients with PsA participating in 4 on-label phase III PsA studies (FUTURE 2-5), and the efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient's global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation) was assessed using multiple measures and definitions specific to each domain. The MEASURE 2 study, a phase III clinical trial in patients with AS, was used to assess improvement in spine symptoms at Week 16.
RESULTS
Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16. Notably, among patients treated with secukinumab 300 mg, 34.3% and 19.5% achieved complete resolution of swollen and tender joint counts, respectively; 53.2% and 61.5% achieved complete resolution of enthesitis and dactylitis, respectively; and 33.2% achieved 100% improvement in Psoriasis Area and Severity Index (all p < 0.05 vs placebo); similar improvements were shown for all other core domains.
CONCLUSION
This analysis suggests that secukinumab can benefit people with PsA across the clinical phenotypic spectrum commonly encountered in this disease.",2020,"RESULTS
Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16.","['Psoriatic Arthritis', '2049 patients with PsA participating in 4 on-label phase 3 PsA studies (FUTURE 2-5', '2049 Patients', '4 phase 3 psoriatic arthritis (PsA) studies and 1 phase 3 ankylosing spondylitis (AS) study']","['placebo', 'Secukinumab', 'secukinumab']","['spine symptoms', 'complete resolution of enthesitis and dactylitis', 'efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation', 'Psoriasis Area and Severity Index', 'complete resolution of swollen and tender joint counts']","[{'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis (disorder)'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis (disorder)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}]",2049.0,0.257259,"RESULTS
Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16.","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA. aorbai1@jhmi.edu.""}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'M Elaine', 'Initials': 'ME', 'LastName': 'Husni', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chambenoit', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': ""From the Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Glasgow, Glasgow; University of Oxford, Oxford, UK; Cleveland Clinic, Cleveland, Ohio, USA; Toronto Western Research Institute and University of Toronto, Toronto, Ontario, Canada; Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique; Pitié Salpêtrière Hospital, AP-HP, Paris, France; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.""}]",The Journal of rheumatology,['10.3899/jrheum.190507']
596,32232692,"Prophylactic efficacy of ninjin'yoeito for oxaliplatin-induced cumulative peripheral neuropathy in patients with colorectal cancer receiving postoperative adjuvant chemotherapy: a randomized, open-label, phase 2 trial (HOPE-2).","PURPOSE
Peripheral neuropathy (PN) is an intractable side effect of oxaliplatin, with no effective prophylaxis so far. Ninjin'yoeito (NYT), a Kampo medicine, is protective against oxaliplatin-induced neuronal cell injury in vitro and ameliorates oxaliplatin-induced PN in vivo. Thus, this randomized controlled trial was aimed at clarifying NYT's prophylactic effect for oxaliplatin-induced cumulative PN.
METHODS
52 patients with colorectal cancers of pathological stage 3 received postoperative adjuvant chemotherapy with the CapeOX regimen: eight cycles of capecitabine (2400 mg/m 2 ) plus oxaliplatin (130 mg/m 2 ) at 3-week intervals. They were randomly assigned to NYT administration and non-administration groups. NYT (9.0 g/day) was administered from day 1 of cycle 1 in the NYT group. The NYT was administered orally daily throughout each cycle. The primary endpoint was the grade of cumulative PN at the end of eight cycles. The secondary endpoints included relative dose intensity (RDI) of oxaliplatin, recurrence-free survival (RFS), and overall survival (OS).
RESULTS
40 patients (n = 20 in both groups) completed 8 chemotherapy cycles. The incidence of grade 2 or greater cumulative PN at the 8th chemotherapy cycle was significantly lower in the NYT group (2/20, 10.0%) than in the control group (11/20, 55.0%, P < 0.01). RDI of oxaliplatin was significantly higher in the NYT group than in the control group (P = 0.02). RFS and OS were better in the NYT group than in the control group, but the difference was not significant.
CONCLUSIONS
NYT may reduce the incidence of oxaliplatin-induced cumulative PN and facilitate maintenance of the CapeOX dosing regimen.",2020,"RFS and OS were better in the NYT group than in the control group, but the difference was not significant.
","['52 patients with colorectal cancers of pathological stage 3 received postoperative adjuvant chemotherapy with the CapeOX regimen: eight cycles of', '40 patients (n\u2009=\u200920 in both groups) completed 8 chemotherapy cycles', 'patients with colorectal cancer receiving postoperative adjuvant chemotherapy']","[""ninjin'yoeito for oxaliplatin"", 'oxaliplatin', 'capecitabine (2400\xa0mg/m 2 ) plus oxaliplatin']","['RFS and OS', 'relative dose intensity (RDI) of oxaliplatin, recurrence-free survival (RFS), and overall survival (OS', 'RDI of oxaliplatin', 'incidence of grade 2 or greater cumulative PN', 'grade of cumulative PN']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle (procedure)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",52.0,0.207819,"RFS and OS were better in the NYT group than in the control group, but the difference was not significant.
","[{'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Motoo', 'Affiliation': 'Department of Medical Oncology, Kanazawa Medical University, 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan. motoo@kanazawa-med.ac.jp.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of General and Gastroenterological Surgery, Kanazawa Medical University, 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of General and Gastroenterological Surgery, Kanazawa Medical University, 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01648-3']
597,31749340,"Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy in Patients with Erectile Dysfunction: A Sham-Controlled, Double-Blind, Randomized Prospective Study.","PURPOSE
The aim of the present study was to evaluate the efficacy and safety of the electromagnetic-type low-intensity extracorporeal shock wave therapy (Li-ESWT) in patients with erectile dysfunction (ED).
MATERIALS AND METHODS
The randomized, sham-controlled, double-blind prospective study was performed at two referral hospitals. Participants were randomized in a 1:1 ratio to receive sham or Li-ESWT for 6 weeks. ED was evaluated at screening and at 4 and 7 weeks after treatment. Participants were asked to complete the international index of erectile function-erectile function (IIEF-EF) domain questionnaire, erection hardness scale (EHS), and sexual encounter profile questionnaire (SEPQ 2 and 3). The development of complications was investigated.
RESULTS
Eighty-one of 96 patients completed the study. The median change in the IIEF-EF score in the Li-ESWT and sham groups was 5.1 and -2.2 (p<0.001), respectively, at the 7-week follow-up; 47.4% (18/38) patients had EHS <3, of which 77.8% (14/18) showed significant improvement in virtue of Li-ESWT treatment (p=0.001). A significant improvement was observed in the percentage of ""Yes"" responses to SEPQ 2 and 3 in the Li-ESWT group vs. sham group from baseline to 7-week follow-up (91.3% vs. 69.4%; p=0.008 and 50.0% vs. 14.3%; p=0.002, respectively). No patients reported pain or other adverse events during treatment or follow-up.
CONCLUSIONS
Thus, Li-ESWT could have a role in improving erectile function. Furthermore, it is safe. We believe that Li-ESWT is an attractive new treatment modality for patients with ED.",2020,"The median change in the IIEF-EF score in the Li-ESWT and sham groups was 5.1 and -2.2 (p<0.001), respectively, at the 7-week follow-up; 47.4% (18/38) patients had EHS <3, of which 77.8% (14/18) showed significant improvement in virtue of Li-ESWT treatment (p=0.001).","['Eighty-one of 96 patients completed the study', 'patients with ED', 'patients with erectile dysfunction (ED', 'Patients with Erectile Dysfunction']","['Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy', 'Li-ESWT', 'sham or Li-ESWT', 'electromagnetic-type low-intensity extracorporeal shock wave therapy (Li-ESWT']","['international index of erectile function-erectile function (IIEF-EF) domain questionnaire, erection hardness scale (EHS), and sexual encounter profile questionnaire (SEPQ 2 and 3', 'efficacy and safety', 'percentage of ""Yes"" responses to SEPQ2', 'median change in the IIEF-EF score', 'pain or other adverse events']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",96.0,0.227714,"The median change in the IIEF-EF score in the Li-ESWT and sham groups was 5.1 and -2.2 (p<0.001), respectively, at the 7-week follow-up; 47.4% (18/38) patients had EHS <3, of which 77.8% (14/18) showed significant improvement in virtue of Li-ESWT treatment (p=0.001).","[{'ForeName': 'Kang Sup', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': ""Department of Urology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Jeong', 'Affiliation': 'Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sae Woong', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': ""Department of Urology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Yong Sun', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': ""Department of Urology, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Hyuk Jin', 'Initials': 'HJ', 'LastName': 'Cho', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'U Syn', 'Initials': 'US', 'LastName': 'Ha', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sung Hoo', 'Initials': 'SH', 'LastName': 'Hong', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Ji Youl', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Seung Wook', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sun Tae', 'Initials': 'ST', 'LastName': 'Ahn', 'Affiliation': 'Department of Urology, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Du Geon', 'Initials': 'DG', 'LastName': 'Moon', 'Affiliation': 'Department of Urology, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woong Jin', 'Initials': 'WJ', 'LastName': 'Bae', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sae Woong', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}]",The world journal of men's health,['10.5534/wjmh.190130']
598,30883495,Practice Structure and Locomotor Learning After Stroke.,"BACKGROUND AND PURPOSE
The optimal characteristics of learning to promote recovery of walking have yet to be defined for the poststroke population. We examined characteristics of task practice that limit or promote learning of a novel locomotor pattern.
METHODS
Thirty-two persons with chronic hemiparesis were randomized to 2 conditions (constant and variable practice) and participated in two 15-minute sessions of split-belt treadmill walking. On day 1, subjects in the constant condition walked on the split-belt treadmill at a constant 2:1 speed ratio, while subjects in the variable condition walked on the split-belt treadmill at 3 different speed ratios. On day 2, both groups participated in 15 minutes of split-belt treadmill walking at the 2:1 speed ratio. Step length and limb phase symmetry metrics were measured to assess within-session learning (ie, adaptation) on day 1 and the ability to retain this new pattern of walking (ie, retention) on day 2.
RESULTS
The amount of adaptation on day 1 did not differ depending upon practice structure (constant and variable) for step length or limb phase (a)symmetry. The magnitude of reduction in asymmetry from day 1 to day 2 did not differ between groups for step and limb phase (a)symmetry.
DISCUSSION AND CONCLUSIONS
The results suggest that variable practice utilizing alternating belt speed ratios does not influence the ability of those with chronic stroke to adapt and retain a novel locomotor pattern. The effects of other forms of variable practice within other locomotor learning paradigms should be explored in those with chronic hemiparesis after stroke.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A257).",2019,"The magnitude of reduction in asymmetry from day 1 to day 2 did not differ between groups for step and limb phase (a)symmetry.
",['Thirty-two persons with chronic hemiparesis'],"['split-belt treadmill walking', 'Locomotor Learning']",['Step length and limb phase symmetry metrics'],"[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}]","[{'cui': 'C0452227', 'cui_str': 'Belt, device (physical object)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",32.0,0.0221342,"The magnitude of reduction in asymmetry from day 1 to day 2 did not differ between groups for step and limb phase (a)symmetry.
","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Helm', 'Affiliation': 'Department of Physical Therapy (D.S.R.), Biomechanics and Movement Science Program (E.E.H., D.S.K., D.S.R.), and Biostatistics Core Facility (R.T.P.), University of Delaware, Newark.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': ''}, {'ForeName': 'Devina S', 'Initials': 'DS', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Darcy S', 'Initials': 'DS', 'LastName': 'Reisman', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000260']
599,30557230,Home-based Cognitive Prehabilitation in Older Surgical Patients: A Feasibility Study.,"BACKGROUND
Cognitive training is beneficial in various clinical settings, although its perioperative feasibility and impact remain unknown. The objective of this pilot study was to determine the feasibility of home-based cognitive prehabilitation before major surgery in older adults.
MATERIALS AND METHODS
Sixty-one patients were enrolled, randomized, and allocated to either a home-based preoperative cognitive training regimen or no training before surgery. Outcomes included postoperative delirium incidence (primary outcome; assessed with the 3D-Confusion Assessment Method), perioperative cognitive function based on NIH Toolbox measures, hospital length of stay, and physical therapy session participation. Reasons for declining enrollment were reported, as were reasons for opting out of the training program.
RESULTS
Postoperative delirium incidence was 6 of 23 (26%) in the prehabilitation group compared with 5 of 29 (17%) in the control group (P=0.507). There were no significant differences between groups in NIH Toolbox cognitive function scoring, hospital length of stay, or physical therapy participation rates. Study feasibility data were also collected and reported. The most common reasons for declining enrollment were lack of computer access (n=19), time commitment (n=9), and feeling overwhelmed (n=9). In the training group, only 5 of 29 (17%) included patients were able to complete the prescribed 7 days of training, and 14 of 29 (48%) opted out of training once home. Most common reasons were feeling overwhelmed (n=4) and computer difficulties (n=3).
CONCLUSIONS
Short-term, home-based cognitive training before surgery is unlikely to be feasible for many older patients. Barriers to training include feeling overwhelmed, technical issues with training, and preoperative time commitment.",2019,"There were no significant differences between groups in NIH Toolbox cognitive function scoring, hospital length of stay, or physical therapy participation rates.","['older patients', 'older adults', 'Sixty-one patients', 'Older Surgical Patients']","['home-based preoperative cognitive training regimen or no training before surgery', 'Home-based Cognitive Prehabilitation', 'Cognitive training', 'home-based cognitive prehabilitation before major surgery']","['NIH Toolbox cognitive function scoring, hospital length of stay, or physical therapy participation rates', 'postoperative delirium incidence (primary outcome; assessed with the 3D-Confusion Assessment Method), perioperative cognitive function based on NIH Toolbox measures, hospital length of stay, and physical therapy session participation', 'Postoperative delirium incidence']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",61.0,0.0372792,"There were no significant differences between groups in NIH Toolbox cognitive function scoring, hospital length of stay, or physical therapy participation rates.","[{'ForeName': 'Phillip E', 'Initials': 'PE', 'LastName': 'Vlisides', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Abhijit R', 'Initials': 'AR', 'LastName': 'Das', 'Affiliation': 'Northeast Ohio Medical University, Rootstown, OH.'}, {'ForeName': 'Allie M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Kunkler', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Zierau', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cantley', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'McKinney', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giordani', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, MI.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000569']
600,32227771,Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial.,"OBJECTIVE
To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction (YHJD) on patients with advanced epithelial ovarian cancer (EOC).
METHODS
All 330 enrolled participants diagnosed with stage Ⅲc EOC were randomly divided into two groups that received YHJD or a placebo. The primary end point was health-related quality of life (HRQL) measured by the functional assessment of cancer therapy-ovary cancer (FACT-O) questionnaire. The secondary end point was progression-free survival (PFS).
RESULTS
A total of 299 participants completed the trial with 153 and 146 in YHJD and control groups, respectively. After 6 months of treatment, YHJD increased physical wellbeing (PWB), functional wellbeing (FWB), additional concerns (AC), and the trial outcome index (TOI) (P < 0.05) by various degrees compared with the baseline. YHJD also had notable advantages over the placebo at 3 and 6 months in terms of PWB, FWB, AC (P < 0.05), and TOI (P < 0.01). In addition, YHJD had a significant advantage in terms of PFS compared with the placebo (21 vs 18 months, P < 0.05). No adverse events were reported.
CONCLUSION
YHJD is an effective and safe choice as a complementary therapy to improve HRQL and prolong PFS of stage Ⅲc EOC patients.",2020,"After 6 months of treatment, YHJD increased physical wellbeing (PWB), functional wellbeing (FWB), additional concerns (AC), and the trial outcome index (TOI) (P < 0.05) by various degrees compared with the baseline.","['advanced epithelial ovarian cancer patients', '299 participants completed the trial with 153 and 146 in YHJD and control groups, respectively', 'patients with advanced epithelial ovarian cancer (EOC', 'All 330 enrolled participants diagnosed with stage Ⅲc EOC']","['placebo', 'Yiqi Huoxue Jiedu decoction (YHJD', 'YHJD', 'Yiqi Huoxue Jiedu decoction', 'YHJD or a placebo']","['health-related quality of life (HRQL', 'functional assessment of cancer therapy-ovary cancer (FACT-O) questionnaire', 'adverse events', 'PFS', 'YHJD increased physical wellbeing (PWB), functional wellbeing (FWB), additional concerns (AC), and the trial outcome index (TOI', 'Efficacy and safety', 'progression-free survival (PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078696', 'cui_str': 'Yiqi Huoxue'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",330.0,0.436796,"After 6 months of treatment, YHJD increased physical wellbeing (PWB), functional wellbeing (FWB), additional concerns (AC), and the trial outcome index (TOI) (P < 0.05) by various degrees compared with the baseline.","[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Bifa', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Department of Pain, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Yitong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Juling', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
601,32227772,Effectiveness of Xinglou Chengqi decoction on constipation in patients with acute ischemic stroke: a randomized controlled trial.,"OBJECTIVE
To evaluate the effectiveness of traditional Chinese herbal Xinglouchengqi (XLCQ) decoction for the treatment of constipation in acute ischemic stroke patients, and figure out the role that bowel movements play in the treatment of acute ischemic stroke.
METHODS
A total of 317 eligible patients were recruited and randomized to the XLCQ group (211 patients) or the control group (106 patients). In addition to conventional standard medical care and rehabilitation, participants in the XLCQ group received XLCQ decoction, while the control group received clysis therapy using glycerin enemas or lactulose oral solution. Both groups were given treatment for 3 to 6 d, during which they received daily visits to record defecation features and accompanying symptoms. Neurological assessments using the National Institutes of Health Stroke Scale (NIHSS) were conducted before and 1 month after treatment.
RESULTS
Patients in the XLCQ group had lower aggregate constipation scores compared with the control group on days 3 and 5 (P < 0.05). Spontaneous bowel movements tended to reappear more rapidly after taking the XLCQ decoction than after conventional laxative treatment. Both the average aggregate constipation score and the time taken to achieve spontaneous bowel movements showed positive correlations with NIHSS scores before and 1 month after treatment (P < 0.01).
CONCLUSION
Treatment with XLCQ decoction effectively alleviated the overall symptoms of constipation in acute ischemic stroke patients. The status of bowel movements in acute ischemic stroke can reflect the severity of neurological impairment and predict neurological outcomes at 1 month.",2020,"RESULTS
Patients in the XLCQ group had lower aggregate constipation scores compared with the control group on days 3 and 5 (P < 0.05).","['group (211 patients) or the control group (106 patients', 'patients with acute ischemic stroke', '317 eligible patients', 'acute ischemic stroke patients']","['traditional Chinese herbal Xinglouchengqi (XLCQ) decoction', 'clysis therapy using glycerin enemas or lactulose oral solution', 'XLCQ', 'XLCQ decoction', 'Xinglou Chengqi decoction']","['Spontaneous bowel movements', 'Health Stroke Scale (NIHSS', 'average aggregate constipation score', 'constipation', 'NIHSS scores', 'overall symptoms of constipation', 'aggregate constipation scores']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C1252332', 'cui_str': 'Lactulose Oral Solution'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",317.0,0.0483157,"RESULTS
Patients in the XLCQ group had lower aggregate constipation scores compared with the control group on days 3 and 5 (P < 0.05).","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Hualei', 'Initials': 'H', 'LastName': 'Geng', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Yinping', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Beijing Pinggu Hospital of Traditional Chinese Medicine, Beijing 101200, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Beijing Changping Hospital of Traditional Chinese Medicine, Beijing 102200, China.'}, {'ForeName': 'Jinbin', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Hospital affiliated to Changzhi Academy of Chinese Medical Sciences, Changzhi 046000, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Yahui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Ruyu', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Yihuai', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Neurology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
602,32227773,"Effectiveness of electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate on postherpetic neuralgia: a randomized controlled trial.","OBJECTIVE
To investigate the effectiveness of electroacupuncture at Jiaji acupoints (EX-B 2) plus moxibustion and intermediate frequency on postherpetic neuralgia (PHN).
METHODS
A total of 140 outpatients who satisfied the inclusion criteria and volunteered for this treatment were randomly divided into treatment (n = 70) and control (n = 70) groups. Both groups received a localized lesion area and electroacupuncture treatment combined with moxibustion and intermediate frequency. The treatment group (TG) increased acupuncture at Jiaji acupoints (EX-B 2) and electroacupuncture. Pain and anxiety were assessed before and after 5, 10, 15, and 20 treatments by using visual pain simulation score (VAS) and Hamilton anxiety scale (HAMA), respectively. Clinical efficacy was also evaluated.
RESULTS
The baseline between the two groups did not significantly differ (P > 0.05). The VAS and HAMA scores of the two groups after treatment significantly decreased compared with those of various treatment stages (P > 0.05). The HAMA score (P < 0.01) of TG was lower than that of the control group (CG). The VAS score of TG was lower than that of CG in the 5th and 10th treatments (P < 0.01). In the 15th and 10th scores, CG was also superior to TG (P < 0.05).
CONCLUSION
The combined treatment of electroacupuncture at Jiaji acupoints (EX-B 2), moxibustion, and intermediate frequency can relieve the pain and anxiety symptoms of PHN. The efficacy of the combined treatment was superior to traditional acupuncture.",2020,The HAMA score (P < 0.01) of TG was lower than that of the control group (CG).,"['postherpetic neuralgia', '140 outpatients who satisfied the inclusion criteria and volunteered for this treatment']","['acupuncture at Jiaji acupoints (EX-B 2) and electroacupuncture', 'electroacupuncture at Jiaji acupoints (EX-B 2), moxibustion, and intermediate frequency', 'localized lesion area and electroacupuncture treatment combined with moxibustion and intermediate frequency', 'electroacupuncture at Jiaji acupoints (EX-B 2) plus moxibustion', 'electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate']","['HAMA score', 'visual pain simulation score (VAS) and Hamilton anxiety scale (HAMA', 'VAS score of TG', 'Clinical efficacy', 'pain and anxiety symptoms of PHN', 'VAS and HAMA scores', 'Pain and anxiety']","[{'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia (disorder)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0045550', 'cui_str': 'sodium 2,5-dichloro-4-bromophenol'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",140.0,0.0252876,The HAMA score (P < 0.01) of TG was lower than that of the control group (CG).,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Health and Rehabilitation College, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Jianbing', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Pain, Chengdu First People's Hospital, Chengdu 610000, China.""}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of infectious,the First Affiliated Hospital of Guangxi Medical University, Nanning 530021, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
603,32057988,Arthroscopy-Assisted Reduction in the Management of Isolated Medial Malleolar Fracture.,"PURPOSE
To evaluate the feasibility of arthroscopic reduction percutaneous fixation (ARPF) in the treatment of isolated medial malleolar fracture and compare the results with those of conventional open reduction internal fixation (ORIF).
METHODS
This prospective study enrolled 77 patients with isolated medial malleolar fracture between November 2011 and February 2016. The patients were assigned to the ARPF (n = 34) and ORIF (n = 43) groups. The Olerud-Molander ankle score (OMAS), ankle range of motion (ROM), visual analog scale, and radiographic evaluation were determined at the scheduled follow-up.
RESULTS
In the ARPF group, 11 of 34 patients (32.4%) had chondral lesions. Tears of the deltoid ligament and anterior inferior tibiofibular ligament were noted in 3 (8.8%) and 15 (44.1%) patients, respectively. The mean follow-up was 5 years. The mean OMAS was higher in the ARPF group than in the ORIF group. The differences were statistically significant at 6 months (mean ± standard deviation, 80.2 ± 4.0 for ARPF vs 77.2 ± 4.1 for ORIF, P = .005) and 1 year (92.9 ± 4.9 vs 88.1 ± 4.6, P < .001), but not at the latest follow-up (P = .081). Ankle ROM was markedly improved in the ARPF group, unlike in the ORIF group at 6 months (dorsiflexion, P = .025; plantarflexion, P < .001) and 1 year (dorsiflexion and plantarflexion, P < .001). The improvement remained at the latest follow-up in plantarflexion (P = .001) but not in dorsiflexion (P = .354).
CONCLUSIONS
Arthroscopy-assisted reduction is a feasible alternative modality with superior short-term outcomes for treating isolated medial malleolar fracture, but its superiority may be attenuated in the intermediate term.
LEVEL OF EVIDENCE
Level III, comparative study.",2020,"The improvement remained present at the latest follow-up in plantar flexion (P = 0.001) but not in dorsiflexion (P = 0.354).
","['77 patients with isolated medial malleolar fracture between November 2011 and February 2016', 'isolated medial malleolar fracture']","['arthroscopic reduction percutaneous fixation (ARPF', 'conventional open reduction internal fixation (ORIF', 'ORIF', 'ARPF', 'Arthroscopy-assisted reduction']","['Ankle ROM', 'mean OMAS', 'plantar flexion', 'Olerud-Molander Ankle Score (OMAS), ankle range of motion (ROM), visual analog scale, and radiographic evaluation', 'chondral lesions', 'Tears of the deltoid ligament and anterior inferior tibiofibular ligament']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1096630', 'cui_str': 'Malleolar fracture'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0441551', 'cui_str': 'Percutaneous fixation of bone (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0442012', 'cui_str': 'Chondral (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}, {'cui': 'C3661495', 'cui_str': 'Anterior Inferior Tibiofibular Ligament'}]",77.0,0.0301002,"The improvement remained present at the latest follow-up in plantar flexion (P = 0.001) but not in dorsiflexion (P = 0.354).
","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'Jia-Xing', 'Initials': 'JX', 'LastName': 'You', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'Hai-Feng', 'Initials': 'HF', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'He-Jun', 'Initials': 'HJ', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'Shun-Wu', 'Initials': 'SW', 'LastName': 'Fan', 'Affiliation': 'Key Laboratory of Musculoskeletal System Degeneration and Regeneration Translational Research of Zhejiang Province, Hangzhou 310016, China.'}, {'ForeName': 'Hong-Ye', 'Initials': 'HY', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China. Electronic address: zjuyjx@zju.edu.cn.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.01.053']
604,29390098,"Phase I trial of rituximab, cladribine, and temsirolimus (RCT) for initial therapy of mantle cell lymphoma.",,2019,,['mantle cell lymphoma'],"['rituximab, cladribine, and temsirolimus (RCT']",[],"[{'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}]",[],,0.0148557,,"[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Inwards', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fishkin', 'Affiliation': ''}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'LaPlant', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Drake', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Kurtin', 'Affiliation': ''}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Nikcevich', 'Affiliation': ''}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Wender', 'Affiliation': ''}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Lair', 'Affiliation': ''}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx814']
605,31307055,Continuous Anticoagulation and Cold Snare Polypectomy Versus Heparin Bridging and Hot Snare Polypectomy in Patients on Anticoagulants With Subcentimeter Polyps: A Randomized Controlled Trial.,"Background
Management of anticoagulants for patients undergoing polypectomy is still controversial. Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).
Objective
To compare outcomes between continuous administration of anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP) for subcentimeter colorectal polyps.
Design
Multicenter, parallel, noninferiority randomized controlled trial. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000019355).
Setting
30 Japanese institutions.
Patients
Patients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp.
Intervention
Patients were randomly assigned to undergo HB+HSP or CA+CSP and followed up 28 days after polypectomy.
Measurements
The primary end point was incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis). The prespecified inferiority margin was -5% (CA+CSP vs. HB+HSP).
Results
A total of 184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment. The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group.
Limitation
An open-label trial assessing 2 factors (anticoagulation approach and polypectomy procedure type) simultaneously.
Conclusion
Patients having CA+CSP for subcentimeter colorectal polyps who were receiving oral anticoagulants did not have an increased incidence of polypectomy-related major bleeding, and procedure time and hospitalization were shorter than in those having HB+HSP.
Primary Funding Source
Japanese Gastroenterological Association.",2019,"Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).
","['Patients\n\n\nPatients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp', '184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment', 'patients undergoing polypectomy', 'subcentimeter colorectal polyps', 'Patients on Anticoagulants With Subcentimeter Polyps', 'Setting\n\n\n30 Japanese institutions']","['Continuous Anticoagulation and Cold Snare Polypectomy Versus', 'HB+HSP', 'Heparin Bridging and Hot Snare Polypectomy', 'anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP', 'Cold snare polypectomy (CSP', 'HB+HSP or CA+CSP', 'CA+CSP']","['incidence of polypectomy-related major bleeding, and procedure time and hospitalization', 'incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis', 'incidence of polypectomy-related major bleeding', 'mean procedure time for each polyp and the hospitalization period']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0183362', 'cui_str': 'Snare, device (physical object)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0085148', 'cui_str': 'Hemostasis, Endoscopic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}]",30.0,0.0950026,"Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).
","[{'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan (Y.T.).'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Mabe', 'Affiliation': 'National Hospital Organization Hakodate National Hospital, Hakodate, Japan (K.M.).'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Shimodate', 'Affiliation': 'Kurashiki Central Hospital, Kurashiki, Japan (Y.S.).'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yoshii', 'Affiliation': 'Sapporo Medical Center Nippon Telegraph and Telephone East Corporation, Sapporo, Japan (S.Y.).'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Ishikawa Prefectural Central Hospital, Kanazawa, Japan (S.Y.).'}, {'ForeName': 'Mineo', 'Initials': 'M', 'LastName': 'Iwatate', 'Affiliation': 'Sano Hospital, Kobe, Japan (M.I.).'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Kyoto Second Red Cross Hospital, Kyoto, Japan (T.K.).'}, {'ForeName': 'Kinichi', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Shizuoka Cancer Center, Suntogun, Shizuoka, Japan (K.H.).'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nagaike', 'Affiliation': 'Suita Municipal Hospital, Suita, Japan (K.N.).'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Ikezawa', 'Affiliation': 'Akashi Medical Center, Akashi, Japan (N.I.).'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Yamasaki', 'Affiliation': 'Osaka City General Hospital, Osaka, Japan (T.Y.).'}, {'ForeName': 'Yoriaki', 'Initials': 'Y', 'LastName': 'Komeda', 'Affiliation': 'Kindai University Faculty of Medicine, Osaka-Sayama, Japan (Y.K.).'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Asai', 'Affiliation': 'Tane General Hospital, Osaka, Japan (S.A.).'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Abe', 'Affiliation': 'Utsunomiya Memorial Hospital, Tochigi, Japan (Y.A.).'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Akamatsu', 'Affiliation': 'Japanese Red Cross Society Wakayama Medical Center, Wakayama, Japan (T.A.).'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Sakakibara', 'Affiliation': 'National Hospital Organization Osaka National Hospital, Osaka, Japan (Y.S.).'}, {'ForeName': 'Hisatomo', 'Initials': 'H', 'LastName': 'Ikehara', 'Affiliation': 'Nihon University School of Medicine, Tokyo, Japan (H.I.).'}, {'ForeName': 'Yuzuru', 'Initials': 'Y', 'LastName': 'Kinjo', 'Affiliation': 'Naha City Hospital, Naha, Japan (Y.K.).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ohta', 'Affiliation': 'Kansai Rosai Hospital, Amagasaki, Japan (T.O.).'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kitamura', 'Affiliation': 'Nara City Hospital, Nara, Japan (Y.K.).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shono', 'Affiliation': 'Kumamoto University, Kumamoto, Japan (T.S.).'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Osaka General Medical Center, Osaka, Japan (T.I.).'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Ohda', 'Affiliation': 'Hyogo College of Medicine, Nishinomiya, Japan (Y.O.).'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Tochigi Cancer Center, Utsunomiya, Japan (N.K.).'}, {'ForeName': 'Tokuma', 'Initials': 'T', 'LastName': 'Tanuma', 'Affiliation': 'Teine Keijinkai Hospital, Sapporo, Japan (T.T.).'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Sapporo Higashi Tokushukai Hospital, Sapporo, Japan (R.S.).'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan (T.S.).'}, {'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Harada', 'Affiliation': 'National Hospital Organization Kyushu Medical Center, Fukuoka, Japan (N.H.).'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Chino', 'Affiliation': 'Cancer Institute Hospital, Tokyo, Japan (A.C.).'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Kyoto Prefectural University of Medicine, Osaka, Japan (H.I.).'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Nojima', 'Affiliation': 'The University of Tokyo, Tokyo, Japan (M.N.).'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Uraoka', 'Affiliation': 'National Hospital Organization Tokyo Medical Center, Tokyo, Japan (T.U.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-0026']
606,31842963,Using the Multiphase Optimization Strategy (MOST) framework to test intervention delivery strategies: a study protocol.,"BACKGROUND
Delivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. The importance of clearly delineating delivery strategies within these complex interventions-and furthermore understanding the impact of each strategy on effectiveness-has recently emerged as an important facet of intervention research. Yet, few methodologies exist to prospectively test the effectiveness of delivery strategies and how they impact implementation. In the current paper, we describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST), a novel framework developed to optimize interventions, i.e., to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation.
METHODS/DESIGN
The MOST framework contains three distinct phases: Preparation, Optimization, and Evaluation. The Preparation phase for this study occurred previously. The current study consists of the Optimization and Evaluation phases. Children aged 3-to-12 years old who are detected as ""at-risk"" for behavioral health disorders (n = 304) at a large, urban federally qualified community health center will be referred to a Family Partner-a bicultural, bilingual member of the community with training in behavioral health and systems navigation-who will perform FN. Families will then be randomized to one of 16 possible combinations of FN delivery strategies (2 × 2 × 2× 2 factorial design). The primary outcome measure will be achieving a family-centered goal related to behavioral health services within 90 days of randomization. Implementation data on the fidelity, acceptability, feasibility, and cost of each strategy will also be collected. Results from the primary and secondary outcomes will be reviewed by our team of stakeholders to optimize FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost.
DISCUSSION
In this protocol paper, we describe how the MOST framework can be used to improve intervention delivery. These methods will be useful for future studies testing intervention delivery strategies and their impact on implementation.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03569449. Registered on 26 June 2018.",2019,"We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation.
","['Children aged 3-to-12 years old who are detected as ""at-risk"" for behavioral health disorders (n\u2009=\u2009304) at a large, urban federally qualified community health center will be referred to a Family Partner-a bicultural, bilingual member of the community with training in behavioral health and systems navigation-who will perform FN']","['Multiphase Optimization Strategy (MOST', 'Family Navigation (FN']","['FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost', 'fidelity, acceptability, feasibility, and cost of each strategy', 'achieving a family-centered goal related to behavioral health services']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]",,0.0650254,"We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation.
","[{'ForeName': 'Sarabeth', 'Initials': 'S', 'LastName': 'Broder-Fingert', 'Affiliation': 'Boston Medical Center, 801 Albany Street, Boston, MA, 02114, USA. sarabeth.broder-fingert@bmc.org.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Kuhn', 'Affiliation': 'Boston Medical Center, 801 Albany Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Radley Christopher', 'Initials': 'RC', 'LastName': 'Sheldrick', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chu', 'Affiliation': 'Boston Medical Center, 801 Albany Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Fortuna', 'Affiliation': 'Boston Medical Center, 801 Albany Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Jordan', 'Affiliation': 'DotHouse Health Center, Dorchester, MA, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Rubin', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': 'Boston Medical Center, 801 Albany Street, Boston, MA, 02114, USA.'}]",Trials,['10.1186/s13063-019-3853-y']
607,32222935,Rating of camera navigation skills in colorectal surgery.,"PURPOSE
In advanced minimally invasive surgery the laparoscopic camera navigation (LCN) quality can influence the flow of the operation. This study aimed to investigate the applicability of a scoring system for LCN (SALAS score) in colorectal surgery and whether an adequate scoring can be achieved using a specified sequence of the operation.
METHODS
The score was assessed by four blinded raters using synchronized video and voice recordings of 20 randomly selected laparoscopic colorectal surgeries (group A: assessment of the entire operation; group B: assessment of the 2nd and 3rd quartile). Experience in LCN was defined as at least 100 assistances in complex laparoscopic procedures.
RESULTS
The surgical teams consisted of three residents, three fellows, and two attendings forming 15 different teams. The ratio between experienced and inexperienced camera assistants was balanced (n = 11 vs. n = 9). Regarding the total SALAS score, the four raters discriminated between experienced and inexperienced camera assistants, regardless of their group assignment (group A, p < 0.05; group B, p < 0.05). The score's interrater variability and reliability were proven with an intraclass correlation coefficient of 0.88. No statistically relevant correlation was achieved between operation time and SALAS score.
CONCLUSION
This study presents the first intraoperative, objective, and structured assessment of LCN in colorectal surgery. We could demonstrate that the SALAS score is a reliable tool for the assessment of LCN even when only the middle part (50%) of the procedure is analyzed. Construct validity was proven by discriminating between experienced and inexperienced camera assistants.",2020,The ratio between experienced and inexperienced camera assistants was balanced (n = 11 vs. n = 9).,['colorectal surgery'],"['synchronized video and voice recordings of 20 randomly selected laparoscopic colorectal surgeries', 'camera navigation skills', 'LCN', 'laparoscopic camera navigation (LCN']","['total SALAS score', 'operation time and SALAS score']","[{'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.0358915,The ratio between experienced and inexperienced camera assistants was balanced (n = 11 vs. n = 9).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huettl', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lang', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paschold', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Watzka', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wachter', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hensel', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kneist', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Huber', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany. Tobias.Huber@unimedizin-mainz.de.'}]",International journal of colorectal disease,['10.1007/s00384-020-03543-9']
608,31626572,"Multicenter, Prospective, Phase II and Biomarker Study of High-Dose Bevacizumab as Induction Therapy in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannoma.","PURPOSE
Bevacizumab treatment at 7.5 mg/kg every 3 weeks results in improved hearing in approximately 35%-40% of patients with neurofibromatosis type 2 (NF2) and progressive vestibular schwannomas (VSs). However, the optimal dose is unknown. In this multicenter phase II and biomarker study, we evaluated the efficacy and safety of high-dose bevacizumab in pediatric and adult patients with NF2 with progressive VS.
PATIENTS AND METHODS
Bevacizumab was given for 6 months at 10 mg/kg every 2 weeks, followed by 18 months at 5 mg/kg every 3 weeks. The primary end point was hearing response defined by word recognition score (WRS) at 6 months. Secondary end points included toxicity, radiographic response, quality of life (QOL), and plasma biomarkers.
RESULTS
Twenty-two participants with NF2 (median age, 23 years) with progressive hearing loss in the target ear (median baseline WRS, 53%) were enrolled. Nine (41%) of 22 participants achieved a hearing response at 6 months (1 of 7 children and 8 of 15 adults; P = .08). Radiographic response was seen in 7 (32%) of 22 patients with VS at 6 months (7 of 15 adults and 0 of 7 children; P = .05). Common mild to moderate adverse events included hypertension, fatigue, headache, and irregular menstruation. Improvement in NF2-related QOL and reduction in tinnitus-related distress were reported in 30% and 60% of participants, respectively. Paradoxically, high-dose bevacizumab treatment was not associated with a significant decrease in free vascular endothelial growth factor but was associated with increased carbonic anhydrase IX, hepatocyte growth factor, placental growth factor, stromal cell-derived factor 1α, and basic fibroblast growth factor concentrations in plasma.
CONCLUSION
High-dose bevacizumab seems to be no more effective than standard-dose bevacizumab for treatment of patients with NF2 with hearing loss. In contrast to adults, pediatric participants did not experience tumor shrinkage. However, adult and pediatric participants reported similar improvement in QOL during induction. Novel approaches using bevacizumab should be considered for children with NF2.",2019,"Improvement in NF2-related QOL and reduction in tinnitus-related distress were reported in 30% and 60% of participants, respectively.","['patients with NF2 with hearing loss', 'pediatric and adult patients with NF2 with progressive VS', 'Twenty-two participants with NF2 (median age, 23 years) with progressive hearing loss in the target ear (median baseline WRS, 53%) were enrolled', 'patients with neurofibromatosis type 2 (NF2) and progressive vestibular schwannomas (VSs', 'Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannoma', 'children with NF2']","['high-dose bevacizumab', 'bevacizumab', 'Bevacizumab', 'High-Dose Bevacizumab']","['hearing response defined by word recognition score (WRS', 'Radiographic response', 'hearing', 'efficacy and safety', 'hearing response', 'toxicity, radiographic response, quality of life (QOL), and plasma biomarkers', 'NF2-related QOL and reduction in tinnitus-related distress', 'carbonic anhydrase IX, hepatocyte growth factor, placental growth factor, stromal cell-derived factor 1α, and basic fibroblast growth factor concentrations in plasma', 'QOL', 'free vascular endothelial growth factor', 'hypertension, fatigue, headache, and irregular menstruation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis, Central, NF 2'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0027859', 'cui_str': 'Neurilemmoma, Acoustic'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis, Central, NF 2'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C4255077', 'cui_str': 'CAIX Protein'}, {'cui': 'C0062534', 'cui_str': 'Hepatopoietin'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0156404', 'cui_str': 'Irregular Menses'}]",22.0,0.0664451,"Improvement in NF2-related QOL and reduction in tinnitus-related distress were reported in 30% and 60% of participants, respectively.","[{'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Plotkin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Dan G', 'Initials': 'DG', 'LastName': 'Duda', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'New York University, New York, NY.'}, {'ForeName': 'Jaishri', 'Initials': 'J', 'LastName': 'Blakeley', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Tena', 'Initials': 'T', 'LastName': 'Rosser', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jian L', 'Initials': 'JL', 'LastName': 'Campian', 'Affiliation': 'Washington University, St Louis, MO.'}, {'ForeName': 'D Wade', 'Initials': 'DW', 'LastName': 'Clapp', 'Affiliation': 'Indiana University, Indianapolis, IN.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fisher', 'Affiliation': ""The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonsgard', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ullrich', 'Affiliation': ""Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Coretta', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Korf', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Packer', 'Affiliation': ""Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Matthias A', 'Initials': 'MA', 'LastName': 'Karajannis', 'Affiliation': 'New York University, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01367']
609,32212856,Augmenting Computerized Cognitive Training With Vortioxetine for Age-Related Cognitive Decline: A Randomized Controlled Trial.,"OBJECTIVE
Age-related cognitive decline, the deterioration in functions such as memory and executive function, is faced by most older adults and affects function and quality of life. No approved treatments exist for age-related cognitive decline. Computerized cognitive training has been shown to provide consistent albeit modest improvements in cognitive function as measured by neuropsychological testing. Vortioxetine, an antidepressant medication, has putative procognitive and proneuroplastic properties and therefore may be able to augment cognitive training. In this placebo-controlled study, the authors tested the cognitive benefits of vortioxetine added to cognitive training for adults age 65 or older with age-related cognitive decline.
METHODS
After a 2-week lead-in period of cognitive training, 100 participants were randomly assigned to receive either vortioxetine or placebo in addition to cognitive training for 26 weeks. The primary outcome measure was global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite. The secondary outcome measure was functional cognition, assessed by the UCSD Performance-Based Skills Assessment. All participants received motivational messaging and support from study staff to maximize adherence to the training.
RESULTS
Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training. This separation was significant at week 12 but not at other assessment time points. Both groups showed improvement in the secondary outcome measure of functional cognition, with no significant difference between groups.
CONCLUSIONS
Vortioxetine may be beneficial for age-related cognitive decline when combined with cognitive training. These findings provide new treatment directions for combating cognitive decline in older adults.",2020,"RESULTS
Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","['adults age 65 or older with age-related cognitive decline', '100 participants', 'Age-Related Cognitive Decline', 'older adults']","['vortioxetine added to cognitive training', 'Computerized cognitive training', 'Computerized Cognitive Training With Vortioxetine', 'placebo', 'motivational messaging', 'vortioxetine or placebo', 'vortioxetine with cognitive training', 'Vortioxetine']","['cognitive function', 'global cognitive performance, assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite', 'global cognitive performance', 'functional cognition', 'functional cognition, assessed by the UCSD Performance-Based Skills Assessment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0236848', 'cui_str': 'Age-related cognitive decline (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0729447', 'cui_str': 'Battery fluid (substance)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",100.0,0.154771,"RESULTS
Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Jill D', 'Initials': 'JD', 'LastName': 'Waring', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Vy T', 'Initials': 'VT', 'LastName': 'Pham', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Shimony', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Healthy Mind Lab, Department of Psychiatry (Lenze, Stevens, Pham, Haddad), Department of Radiology (Shimony), and Division of Biostatistics (Miller), Washington University School of Medicine, St. Louis; Department of Psychology, St. Louis University, St. Louis (Waring); and Department of Psychology, Queen's University, Kingston, Ontario (Bowie).""}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.19050561']
610,32151570,A community-based effort to increase the rate of follow-up eye examinations of school-age children who fail vision screening: a randomized clinical trial.,"PURPOSE
To determine whether enhanced follow-up after failed vision screening, involving more communication with parents/guardians than occurs in a standard protocol, would result in a higher rate of post-screening examination by an eye care provider.
METHODS
In a study conducted from January through December 2017, 162 children in first- and third-grade who failed a vision screening in their Wayne County, Michigan, schools were randomly assigned to receive an enhanced or the standard follow-up protocol.
RESULTS
The average age of the children was 7.9 ± 1.1years; 84 (52%) were males. In the enhanced follow-up group, 52 of 80 (65%) had a documented eye examination within 16 weeks of their screening; the rate in those receiving standard follow-up was 48% (39/82). The intergroup difference in follow-up was 17.4% (95% CI, 2.4%-32.5%). The enhanced follow-up group's odds of obtaining a documented eye examination was twice that of the standard follow-up group (OR = 2.05; 95% CI, 1.09-3.85; P = 0.026).
CONCLUSIONS
In this study cohort, methods to enhance communication proved effective in increasing the likelihood that children who failed vision screenings would receive an examination by an eye care provider.",2020,"The intergroup difference in follow-up was 17.4% (95% CI, 2.4%-32.5%).","['school-age children who fail vision screening', 'January through December 2017, 162 children in first- and third-graders who failed a vision screening in their Wayne County, Michigan, schools', 'The average age of the children was 7.9 ± 1.1years; 84 (52%) were males']",[],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042792', 'cui_str': 'Vision Screening'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],[],,0.120289,"The intergroup difference in follow-up was 17.4% (95% CI, 2.4%-32.5%).","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan. Electronic address: dmusch@med.umich.edu.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Andrews', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schumann', 'Affiliation': 'Department of Health and Human Services, State of Michigan, Lansing, Michigan.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': ""Children's Hospital of Michigan, Detroit, Michigan.""}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2019.12.012']
611,31485929,"Surgeon-delivered laparoscopic transversus abdominis plane blocks are non-inferior to anesthesia-delivered ultrasound-guided transversus abdominis plane blocks: a blinded, randomized non-inferiority trial.","BACKGROUND
The transversus abdominis plane (TAP) block is an important non-narcotic adjunct for post-operative pain control in abdominal surgery. Surgeons can use laparoscopic guidance for TAP block placement (LTAP), however, direct comparisons to conventional ultrasound-guided TAP (UTAPs) have been lacking. The aim of this study is to determine if surgeon placed LTAPs were non-inferior to anesthesia placed UTAPs for post-operative pain control in laparoscopic colorectal surgery.
METHODS
This was a prospective, randomized, patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing laparoscopic colorectal surgery. Narcotic consumption and pain scores were compared for LTAP vs. UTAP for 48 h post-operatively.
RESULTS
60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively. There was no significant difference in post-operative narcotic consumption between UTAP and LTAP at the time of PACU discharge (median [IQR] milligrams of morphine, 1.8 [0-4.5] UTAP vs. 0 [0-8.7] LTAP P = .32), 6 h post-operatively (5.4 [1.8-17.1] UTAP vs. 3.6 [0-12.6] LTAP P = .28), at 12 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .51), at 24 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .63), and 48 h post-operatively (39.9 [7.5-70.2] UTAP vs. 22.2 [7.5-63.8] LTAP P = .41). Patient-reported pain scores as well as pre-, intra-, and post-operative course were similar between groups. Non-inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h.
CONCLUSIONS
Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period.
TRIAL REGISTRY
The trial was registered at clinicaltrials.gov Identifier NCT03577912.",2020,"inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h.
CONCLUSIONS
Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period.
","['patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing', '60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively']","['LTAP vs. UTAP', 'Surgeon-delivered laparoscopic transversus abdominis plane blocks', 'laparoscopic guidance for TAP block placement (LTAP', 'conventional ultrasound-guided TAP (UTAPs', 'anesthesia-delivered ultrasound-guided transversus abdominis plane blocks', 'laparoscopic colorectal surgery', 'transversus abdominis plane (TAP) block']","['pain scores', 'time of PACU discharge', 'Narcotic consumption and pain scores', 'post-operative narcotic consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",60.0,0.348947,"inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h.
CONCLUSIONS
Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period.
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wong', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Curran', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Vitaliy Y', 'Initials': 'VY', 'LastName': 'Poylin', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Cataldo', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA. Tcatald1@bidmc.harvard.edu.'}]",Surgical endoscopy,['10.1007/s00464-019-07097-y']
612,32222326,Impacting child health outcomes in congenital heart disease: Cluster randomized controlled trial protocol of in-clinic physical activity counselling.,"BACKGROUND
Most (>90%) children with congenital health defects are not active enough for optimal health. Proactively promoting physical activity during every clinic visit is recommended, but rarely implemented due to a lack of appropriate resources.
METHODS
This cluster randomized controlled trial will implement an evidence-based, multi-faceted physical activity intervention. All eligible patients at small (London, ON), medium (Ottawa, ON) and large (Edmonton, AB) pediatric cardiac clinics will be approached, with randomization to intervention/control by clinic and week. Intervention patients will be counselled with 5 key physical activity messages, have questions about physical activity answered, and have access to a custom web site with personalized activity suggestions and support from a Registered Kinesiologist. The primary outcome is daily physical activity (number of steps, minutes of moderate-to-vigorous activity) assessed via pedometer one week per month for 6-months. Standardized questionnaires assess activity motivation and quality of life at baseline and end of study. Healthcare outcomes will be clinic visit time and contacts for physical activity concerns. Repeated measures ANCOVA will compare control/intervention pedometer outcomes, adjusting for covariates (alpha=0.05).
CONCLUSIONS
This trial aims to determine whether providing resources and protocols enables clinicians to counsel about physical activity as part of every pediatric cardiology appointment. Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics. The impact on physical activity motivation and participation will evaluate the effectiveness of this standardized approach for increasing physical activity in children with congenital heart defects.",2020,"Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics.","['children with congenital health defects', 'Most (>90%) children with congenital health defects', 'all pediatric cardiac clinics', 'All eligible patients at small (London, ON), medium (Ottawa, ON) and large (Edmonton, AB) pediatric cardiac clinics', 'congenital heart disease']",['clinic physical activity counselling'],"['daily physical activity (number of steps, minutes of moderate-to-vigorous activity) assessed via pedometer one week per month for 6-months', 'Standardized questionnaires assess activity motivation and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0034380'}]",,0.168498,"Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics.","[{'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Lemire', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Yaraskavitch', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lougheed', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Stollery Children's Hospital, Department of Pediatrics, Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Norozi', 'Affiliation': ""Department of Pediatrics, Pediatric Cardiology, Schulich School of Medicine and Dentistry, Western University & Children's Health Research Institute, London, Ontario, Canada; Paediatric Cardiology and Intensive Care Medicine, Medical School Hannover, Germany.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Canadian Congenital Heart Alliance, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Willan', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Longmuir', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada. Electronic address: plongmuir@cheo.on.ca.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105994']
613,31722594,Long-term outcome of brain structure in female preterm infants: possible associations of liberal versus restrictive red blood cell transfusions.,"Background: Preterm infants who receive differential red blood cell (RBC) transfusions at birth may show brain structure differences across development, including abnormalities in white matter (WM) structure and organization. This study investigated long-term outcomes of brain structure in female infants born preterm, at an average age of 13 years old, who received red blood cell (RBC) transfusions in the neonatal period according to a liberal or restrictive approach. Results from this study will increase understanding of the effects of transfusion on the developing brain. Study design and methods: This follow-up study included female preterm infants who participated in a clinical trial and had been randomized at birth to either a liberal or restrictive hematocrit threshold. Brain structures were measured in childhood using structural magnetic resonance imaging (MRI) scans. Due to the low number of females in the restrictive transfusion group at follow-up, additional females were recruited for inclusion. Main outcome measures included cerebral and subcortical brain region volumes. Results: Total intracranial volume was significantly decreased in females who were randomized to higher average hematocrit levels at birth. Infants in the liberal transfusion group had proportionately smaller volumes in all measures of regional cerebral WM and subcortical brain volumes, reaching significance for temporal lobe WM and caudate volumes. Conclusion: Female premature infants who received a liberal transfusion threshold at birth had decreased WM volumes, which suggests the potential long-term neurodevelopmental risks associated with liberal transfusion practices.",2019,"Infants in the liberal transfusion group had proportionately smaller volumes in all measures of regional cerebral WM and subcortical brain volumes, reaching significance for temporal lobe WM and caudate volumes.","['female preterm infants', 'Female premature infants who received a liberal transfusion threshold at birth', 'female preterm infants who participated in a clinical trial and had been randomized at birth to either a liberal or restrictive hematocrit threshold', 'female infants born preterm, at an average age of 13\u2009years old, who received red blood cell (RBC) transfusions in the neonatal period according to a liberal or restrictive approach', 'Preterm infants who receive differential red blood cell (RBC) transfusions at birth']",['liberal versus restrictive red blood cell transfusions'],"['WM volumes', 'Total intracranial volume', 'cerebral and subcortical brain region volumes', 'regional cerebral WM and subcortical brain volumes, reaching significance for temporal lobe WM and caudate volumes']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]","[{'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}]",,0.0713592,"Infants in the liberal transfusion group had proportionately smaller volumes in all measures of regional cerebral WM and subcortical brain volumes, reaching significance for temporal lobe WM and caudate volumes.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Benavides', 'Affiliation': 'Department of Psychiatry, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Conrad', 'Affiliation': ""University of Iowa Stead Family Children's Hospital, Iowa City, IA, USA.""}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Brumbaugh', 'Affiliation': 'Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Magnotta', 'Affiliation': 'Department of Radiology, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Bell', 'Affiliation': ""University of Iowa Stead Family Children's Hospital, Iowa City, IA, USA.""}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Nopoulos', 'Affiliation': 'Department of Psychiatry, University of Iowa, Iowa City, IA, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1683157']
614,32220551,Once-weekly dulaglutide versus insulin glargine in the early control of fasting serum glucose and HbA1c.,"AIMS
To determine the early benefit:risk balance of dulaglutide versus insulin glargine in patients with type 2 diabetes mellitus (T2DM).
METHODS
This post hoc analysis used data from a randomized, open-label study (AWARD-2; modified intention-to-treat group) in which suboptimally controlled metformin + glimepiride-treated patients received dulaglutide 1.5 mg (n = 273) or insulin glargine (n = 262). Two composite endpoints were used: for weeks 2-20, fasting serum glucose (FSG) <130 mg/dL (<7.2 mmol/L) without hypoglycemia (blood glucose ≤70 mg/dL [≤3.9 mmol/L] or severe hypoglycemia); at week 26, patients with glycated hemoglobin (HbA1c) <7.0% (<53.0 mmol/mol) or reduction from baseline ≥1.0% (≥10.9 mmol/mol), no hypoglycemia (as defined above) and no weight gain. Odds ratios (ORs) were generated using logistic regression analysis.
RESULTS
The probability of reaching the FSG target without hypoglycemia was higher with dulaglutide than with insulin glargine at weeks 4 (OR 1.78; 95% confidence interval [CI] 1.22-2.60) and 8 (OR 1.69; 95% CI 1.15-2.48). The proportion of patients achieving the 26-week endpoint was higher with dulaglutide (37.4% vs. 10.3%; OR 5.28; 95% CI 3.28-8.48).
CONCLUSIONS
Dulaglutide's balanced efficacy-to-safety profile compares favorably with that of insulin glargine and is apparent soon after treatment initiation and after 6 months of therapy.",2020,The probability of reaching the FSG target without hypoglycemia was higher with dulaglutide than with insulin glargine at weeks 4 (OR 1.78; 95% confidence interval [CI] 1.22-2.60) and 8 (OR 1.69; 95% CI 1.15-2.48).,['patients with type 2 diabetes mellitus (T2DM'],"['insulin glargine', 'metformin\u202f+\u202fglimepiride-treated patients received dulaglutide 1.5\u202fmg (n\u202f=\u202f273) or insulin glargine', 'dulaglutide versus insulin glargine']","['severe hypoglycemia', 'Odds ratios (ORs', 'probability of reaching the FSG target without hypoglycemia', 'dulaglutide', 'no hypoglycemia', 'fasting serum glucose (FSG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}]",,0.128845,The probability of reaching the FSG target without hypoglycemia was higher with dulaglutide than with insulin glargine at weeks 4 (OR 1.78; 95% confidence interval [CI] 1.22-2.60) and 8 (OR 1.69; 95% CI 1.15-2.48).,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Romera', 'Affiliation': 'Eli Lilly and Company, Avenida de la Industria 30, 28108 Alcobendas, Madrid, Spain. Electronic address: romera_irene@lilly.com.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Conget', 'Affiliation': 'Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Carrer de Villarroel 170, 08036 Barcelona, Spain. Electronic address: ICONGET@clinic.cat.'}, {'ForeName': 'Luis Alberto', 'Initials': 'LA', 'LastName': 'Vazquez', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Av. de Valdecilla, s/n. 39008, Santander, Spain.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Gentilella', 'Affiliation': 'Jazz Healthcare Italy s.r.l., Italy.'}, {'ForeName': 'Jeremie', 'Initials': 'J', 'LastName': 'Lebrec', 'Affiliation': 'HaaPACS GmbH, Bahnhofstr. N°19 C, 69198 Schriesheim, Germany. Electronic address: Lebrec_jeremie@network.lilly.com.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Jódar', 'Affiliation': 'Hospital Universitario Quirón Salud, Calle Diego de Velázquez, 1, 28223 Pozuelo de Alarcón, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Reviriego', 'Affiliation': 'Eli Lilly and Company, Avenida de la Industria 30, 28108 Alcobendas, Madrid, Spain. Electronic address: reviriego_jesus@lilly.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107575']
615,27034455,The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.,"BACKGROUND
Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration, and quality of life among patients with symptomatic diabetic peripheral neuropathy.
METHODS
We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. A total of 1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm. In September 2014, we began identification and recruitment of patients assigned to physicians in the intervention group who receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls.
RESULTS
Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of 27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation. We consented and enrolled 1206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age is 67 (standard deviation = 12) years. The racial ethnic make-up is 56% White, 8% Asian, 13% Black or African American, and 19% Hispanic or Latino.
CONCLUSION
Innovative strategies are needed to guide improvements in healthcare delivery for patients with symptomatic diabetic peripheral neuropathy. This trial aims to assess whether real-time collection and clinical feedback of patient treatment experiences can reduce patient symptom burden. Implementation of a clinical trial closely involving clinical care required researchers to partner with clinicians. If successful, this intervention provides a critical information feedback loop that would optimize diabetic peripheral neuropathy medication titration through widely available interactive voice response technology.",2016,We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines.,"['27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation', '1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California', 'Among those enrolled, 53% are women and the mean age is 67 (standard deviation\u2009=\u200912)\u2009years', 'patients with symptomatic diabetic peripheral neuropathy']","['automated interactive voice response', 'three non-interactive automated educational phone calls']",['quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",[{'cui': 'C0034380'}],2078.0,0.0805978,We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines.,"[{'ForeName': 'Alyce S', 'Initials': 'AS', 'LastName': 'Adams', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA Alyce.S.Adams@kp.org.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bayliss', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Altschuler', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dyer', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Neugebauer', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Jaffe', 'Affiliation': 'South San Francisco Medical Center, Kaiser Permanente, South San Francisco, CA, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Oakland Medical Center, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Oakland Medical Center, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Grant', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774516631530']
616,32222135,Rivaroxaban in Peripheral Artery Disease after Revascularization.,"BACKGROUND
Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and safety of rivaroxaban in this context are uncertain.
METHODS
In a double-blind trial, patients with peripheral artery disease who had undergone revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) was a secondary safety outcome.
RESULTS
A total of 6564 patients underwent randomization; 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group; the Kaplan-Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P = 0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07). ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06%; hazard ratio, 1.42; 95% CI, 1.10 to 1.84; P = 0.007).
CONCLUSIONS
In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone. (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.).",2020,"TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07).","['patients with peripheral artery disease who had undergone lower-extremity revascularization', 'patients with peripheral artery disease who had undergone revascularization', '508 patients in the', 'Peripheral Artery Disease after Revascularization', 'Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events', '6564 patients underwent randomization; 3286 were assigned to the']","['aspirin', 'placebo', 'Rivaroxaban', 'aspirin or placebo plus aspirin', 'rivaroxaban']","['composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes', 'efficacy and safety', 'TIMI major bleeding', 'incidence of TIMI major bleeding', 'ISTH major bleeding', 'incidence of ISTH major bleeding', 'acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes', 'Kaplan-Meier estimates of the incidence', 'major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",6564.0,0.574825,"TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07).","[{'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Bauersachs', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'E Sebastian', 'Initials': 'ES', 'LastName': 'Debus', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nehler', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Fanelli', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Warren H', 'Initials': 'WH', 'LastName': 'Capell', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Diao', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jaeger', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Connie N', 'Initials': 'CN', 'LastName': 'Hess', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Akos F', 'Initials': 'AF', 'LastName': 'Pap', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kittelson', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Gudz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Mátyás', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Dainis K', 'Initials': 'DK', 'LastName': 'Krievins', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lloyd P', 'Initials': 'LP', 'LastName': 'Haskell', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}]",The New England journal of medicine,['10.1056/NEJMoa2000052']
617,32219705,Does quality of life feedback promote seeking help for undiagnosed cancer?,"PURPOSE
Diagnosing cancer early is an imperative, as help-seeking delays affect survival. Quality of life (QoL) deteriorates after diagnosis, but decline may start when cancer is suspected at the earliest stage of the pathway to treatment. This study examined whether offering guided feedback about personal QoL to adults with potential cancer symptoms, living in deprived communities, changes QoL and promotes help-seeking in primary care.
METHODS
Visitors to a CRUK mobile cancer roadshow were recruited in 43 sites. A prospective longitudinal (2 × 2) repeated-measures design was applied. Where they presented a potential cancer symptom, and were 'signposted' to a GP, they were allocated to a symptom condition, or a lifestyle condition, if seeking cancer risk advice. Randomisation was to an Intervention group, who received feedback about personal QoL results (WHOQOL-BREF and WHOQOL importance measures), or a Control group who assessed QoL without feedback. Depression was screened.
RESULTS
Of 107 participants, the mean age was 53; 50% were women, 57% were without tertiary education, 66% were unemployed and 45% were currently ill. Over 10 weeks, 54% of all those with symptoms sought help from a medical source and 42% specifically from a GP. Thirty-one completed all three assessments. With symptoms present, psychological, social and environmental QoL were poor, becoming poorer over time. When the symptoms group received feedback, psychological QoL increased, but GP visits were unaffected. However, feedback increased help-seeking from informal social contacts. Lifestyle groups reported consistently good psychological and social QoL.
CONCLUSION
This early cancer research offers practical and theoretical implications for QoL interventions in deprived communities.",2020,"When the symptoms group received feedback, psychological QoL increased, but GP visits were unaffected.","['Visitors to a CRUK mobile cancer roadshow were recruited in 43 sites', 'adults with potential cancer symptoms, living in deprived communities, changes QoL and promotes help-seeking in primary care', '107 participants', 'mean age was 53; 50% were women, 57% were without tertiary education, 66% were unemployed and 45% were currently ill']","['guided feedback about personal QoL', 'feedback about personal QoL results (WHOQOL-BREF and WHOQOL importance measures), or a Control group who assessed QoL without feedback']","['good psychological and social QoL', 'Quality of life (QoL) deteriorates', 'feedback, psychological QoL increased, but GP visits', 'psychological, social and environmental QoL']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",107.0,0.0221673,"When the symptoms group received feedback, psychological QoL increased, but GP visits were unaffected.","[{'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Skevington', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, International Hub for Quality of Life Research, Manchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UK. suzanne.skevington@manchester.ac.uk.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Long', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, International Hub for Quality of Life Research, Manchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gartland', 'Affiliation': 'Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, International Hub for Quality of Life Research, Manchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UK.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02431-7']
618,31504596,Prostate-Specific Antigen Levels During Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial.,"CONTEXT
Prostate-specific antigen (PSA) changes during testosterone treatment of older hypogonadal men have not been rigorously evaluated.
DESIGN
Double-blinded, placebo-controlled trial.
SETTING
Twelve US academic medical centers.
PARTICIPANTS
Seven hundred ninety hypogonadal men ≥65 years of age with average testosterone levels ≤275 ng/dL. Men at high risk for prostate cancer were excluded.
INTERVENTIONS
Testosterone or placebo gel for 12 months.
MAIN OUTCOMES
Percentile changes in PSA during testosterone treatment of 12 months.
RESULTS
Testosterone treatment that increased testosterone levels from 232 ± 63 ng/dL to midnormal was associated with a small but substantially greater increase (P < 0.001) in PSA levels than placebo treatment. Serum PSA levels increased from 1.14 ± 0.86 ng/mL (mean ± SD) at baseline by 0.47 ± 1.1 ng/mL at 12 months in the testosterone group and from 1.25 ± 0.86 ng/mL by 0.06 ± 0.72 ng/mL in the placebo group. Five percent of men treated with testosterone had an increase ≥1.7 ng/mL and 2.5% of men had an increase of ≥3.4 ng/mL. A confirmed absolute PSA >4.0 ng/mL at 12 months was observed in 1.9% of men in the testosterone group and 0.3% in the placebo group. Four men were diagnosed with prostate cancer; two were Gleason 8.
CONCLUSIONS
When hypogonadal older men with normal baseline PSA are treated with testosterone, 5% had an increase in PSA ≥1.7 ng/mL, and 2.5% had an increase ≥3.4 ng/mL.",2019,Serum PSA levels increased from 1.14±0.86 ng/mL (mean ±SD) at baseline by 0.47±1.1 ng/mL at 12 months in the testosterone group and from 1.25±0.86 ng/mL by 0.06±0.72 ng/mL in the placebo group.,"['790 hypogonadal men ≥65 years with average testosterone levels ≤275 ng/dL. Men at high risk for prostate cancer were excluded', 'older hypogonadal men', 'Four men were diagnosed with prostate cancer', 'Twelve United States academic medical centers', 'Hypogonadal Older Men']","['placebo', 'testosterone', 'Testosterone', 'Testosterone or placebo gel']","['testosterone levels', 'PSA levels', 'Serum PSA levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",790.0,0.749418,Serum PSA levels increased from 1.14±0.86 ng/mL (mean ±SD) at baseline by 0.47±1.1 ng/mL at 12 months in the testosterone group and from 1.25±0.86 ng/mL by 0.06±0.72 ng/mL in the placebo group.,"[{'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Cunningham', 'Affiliation': ""Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine, Baylor St. Luke's Medical Center, Houston, Texas.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Alvin M', 'Initials': 'AM', 'LastName': 'Matsumoto', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, Moores Comprehensive Cancer Center, University of California San Diego, San Diego, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preston', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Division of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Kristine E', 'Initials': 'KE', 'LastName': 'Ensrud', 'Affiliation': 'Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, School of Public Health at UAB, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging & Geriatric Research, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molitch', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Cifelli', 'Affiliation': 'Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Diem', 'Affiliation': 'Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00806']
619,30849721,"An inactive control of the 'Trier Social Stress Test' for Youth 10-17 years: Neuroendocrine, cardiac, and subjective responses.","The Trier Social Stress Test for children (TSST-C) adapted from TSST is one of the most commonly used laboratory paradigms for investigating the effects of stress on cognitive, affective and physiological responses in children and adolescents. Considering that laboratory procedures generate a significant amount of stress to children and adolescents, even in the absence of a stress paradigm, it is important to validate TSST-C against an inactive control condition in which the stress components were absent. Using a randomized design, we tested an inactive control condition, which replaced the TSST-C with a benign video clip (nature scenes viewed while standing), thus removing the stress associated components of the TSST-C. Eighty-eight youth between the ages of 10 and 17 years were randomly assigned to complete the TSST-C or the Inactive Control (IC). Subjective anxiety rating, salivary cortisol, systolic and diastolic blood pressure, and heart rate were collected at eight time points. Subjects in the Inactive Control condition showed no significant changes in blood pressure and heart rate, and decreased anxiety rating and salivary cortisol level throughout the study. Subjects in the stress condition (TSST-C) showed increased anxiety ratings, salivary cortisol, systolic and diastolic blood pressure, and heart rate immediately following TSST-C stress induction. Our findings validated that the TSST-C induced a systemic stress response, and that the Inactive Control can be a promising standardized control condition for the TSST-C and a tool for future psychobiological research. Our results also showed that anxiety reactivity decreased with age while HR reactivity increased with age. Cortisol reactivity did not fall in a linear relationship with age but rather via a quadratic curve, suggesting the mid-age adolescents had the highest cortisol responses to stress compared to their younger and older peers, potentially due to a dual factor of pubertal development and self-control and emotion regulation capacity.",2019,"Subjects in the Inactive Control condition showed no significant changes in blood pressure and heart rate, and decreased anxiety rating and salivary cortisol level throughout the study.","['TSST-C. Eighty-eight youth between the ages of 10 and 17 years', 'children and adolescents']","['TSST-C or the Inactive Control (IC', 'TSST-C with a benign video clip (nature scenes viewed while standing']","['HR reactivity', 'Cortisol reactivity', 'anxiety ratings, salivary cortisol, systolic and diastolic blood pressure, and heart rate immediately following TSST-C stress induction', 'anxiety reactivity', 'Subjective anxiety rating, salivary cortisol, systolic and diastolic blood pressure, and heart rate', 'blood pressure and heart rate, and decreased anxiety rating and salivary cortisol level']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",88.0,0.013836,"Subjects in the Inactive Control condition showed no significant changes in blood pressure and heart rate, and decreased anxiety rating and salivary cortisol level throughout the study.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States; Developmental Electrophysiology Laboratory, Yale Child Study Center, New Haven, CT, United States. Electronic address: jia.wu@yale.edu.'}, {'ForeName': 'Tammi-Marie', 'Initials': 'TM', 'LastName': 'Phillip', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Doretto', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Sao Paulo, Brazil.'}, {'ForeName': 'Stefon', 'Initials': 'S', 'LastName': 'van Noordt', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States; Developmental Electrophysiology Laboratory, Yale Child Study Center, New Haven, CT, United States; Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Tara M', 'Initials': 'TM', 'LastName': 'Chaplin', 'Affiliation': 'Department of Psychology, George Mason University, Fairfax, VA, United States.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Hommer', 'Affiliation': 'Genetic Epidemiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Mayes', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States; Developmental Electrophysiology Laboratory, Yale Child Study Center, New Haven, CT, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States; Program for Anxiety Disorders, Yale Child Study Center, New Haven, CT, United States; Developmental Electrophysiology Laboratory, Yale Child Study Center, New Haven, CT, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.02.027']
620,32103160,Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial.,"OBJECTIVE
To examine the effects of 30% oral dextrose on biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress in preterm neonates experiencing a clinically required heel lance.
STUDY DESIGN
Utilizing a prospective study design, preterm neonates that met study criteria (n = 169) were randomized to receive either (1) 30% oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2 min before heel lance. Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance. Pain was measured using the premature infant pain profile-revised (PIPP-R).
RESULTS
Oral dextrose, administered alone or with facilitated tucking, did not alter plasma markers of ATP utilization and oxidative stress.
CONCLUSION
A single dose of 30% oral dextrose, given before a clinically required heel lance, decreased signs of pain without increasing ATP utilization and oxidative stress in premature neonates.",2020,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","['preterm neonates that met study criteria (n\u2009=\u2009169', 'premature neonates', 'preterm neonates', 'preterm neonates experiencing a clinically required heel lance']","['Oral dextrose', 'oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2\u2009min before heel lance', '30% oral dextrose']","['premature infant pain profile-revised (PIPP-R', 'plasma markers of ATP utilization and oxidative stress', 'biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress', 'Pain', 'procedural pain', 'Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C3179031', 'cui_str': 'Facilitated Tucking'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}]",169.0,0.263784,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","[{'ForeName': 'Danilyn M', 'Initials': 'DM', 'LastName': 'Angeles', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA. dangeles@llu.edu.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Boskovic', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Tan', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'School of Public Health, Loma Linda Univeristy, Loma Linda, CA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hoch', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Forde', 'Affiliation': 'School of Nursing, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Raylene M', 'Initials': 'RM', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hopper', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Deming', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Giang', 'Initials': 'G', 'LastName': 'Truong', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Aprille', 'Initials': 'A', 'LastName': 'Febre', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pegis', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Lavery', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Munaf', 'Initials': 'M', 'LastName': 'Kadri', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Anamika', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Mousselli', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Vora', 'Initials': 'V', 'LastName': 'Farha', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Elba', 'Initials': 'E', 'LastName': 'Fayard', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0634-0']
621,31753727,"Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial.","BACKGROUND
Ramucirumab-an IgG1 vascular endothelial growth factor receptor 2 antagonist-plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial.
METHODS
We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m 2 (60 mg/m 2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues.
FINDINGS
Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5-13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months [95% CI 3·3-4·8] vs 2·8 months [2·6-2·9]; HR 0·696 [95% CI 0·573-0·845]; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9-11·4) in the ramucirumab group versus 7·9 months (7·0-9·3) in the placebo group (stratified HR 0·887 [95% CI 0·724-1·086]; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group.
INTERPRETATION
Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population.
FUNDING
Eli Lilly and Company.",2020,Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group).,"['patients with platinum-refractory advanced urothelial carcinoma', 'patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE', '0·887', 'patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy', 'Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries', 'Between July 20, 2015, and April 4, 2017, 530 patients']","['docetaxel', 'ramucirumab plus docetaxel', 'Ramucirumab plus docetaxel', 'placebo', 'interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m 2 (60 mg/m 2 in Korea, Taiwan, and Japan', 'placebo plus docetaxel']","['leading to death', 'Progression-free survival', 'progression-free survival', 'progression-free survival at the overall survival database lock, median progression-free survival', 'overall survival', 'febrile neutropenia', 'neutropenia', 'Median overall survival', 'Serious adverse events', 'Grade 3 or worse treatment-related treatment-emergent adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",530.0,0.755003,Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group).,"[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, Yale University, New Haven, CT, USA. Electronic address: daniel.petrylak@yale.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Drakaki', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'San Camillo and Forlanini Hospitals, Rome, Italy.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Hospital Universitario 12 de Octubre (CiberOnc), Madrid, Spain.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Fléchon', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Evan Y', 'Initials': 'EY', 'LastName': 'Yu', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Michiel S', 'Initials': 'MS', 'LastName': 'van der Heijden', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'P.A. Herzen Moscow Oncological Research Institute, Moscow, Russia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Géczi', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Yen-Chuan', 'Initials': 'YC', 'LastName': 'Ou', 'Affiliation': ""Tungs' Taichung Metro Harbor Hospital, Taichung, Taiwan.""}, {'ForeName': 'Hasan Senol', 'Initials': 'HS', 'LastName': 'Coskun', 'Affiliation': 'Akdeniz University School of Medicine, Antalya, Turkey.'}, {'ForeName': 'Wen-Pin', 'Initials': 'WP', 'LastName': 'Su', 'Affiliation': 'Institute of Clinical Medicine, College of Medicine, National Cheng Kung University & Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'Department of Urology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gakis', 'Affiliation': 'Department of Urology, University of Tübingen, Tübingen, Germany; Pediatric Urology, Julius Maximillians University, Würzburg, Germany.'}, {'ForeName': 'Ivor J', 'Initials': 'IJ', 'LastName': 'Percent', 'Affiliation': 'Florida Cancer Specialists, Port Charlotte, FL, USA.'}, {'ForeName': 'Jae-Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, University of Turin, San Luigi Gonzaga Hospital, Turin, Italy.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Semenov', 'Affiliation': 'RBHI Ivanovo Regional Oncology Dispensary, Ivanovo, Russia.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Laestadius', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Peer', 'Affiliation': 'Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Tortora', 'Affiliation': 'University of Verona and Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Sufia', 'Initials': 'S', 'LastName': 'Safina', 'Affiliation': 'Tatarstan Regional Cancer Center, Kazan, Russia.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Garcia Del Muro', 'Affiliation': ""Institut Català d'Oncologia L'Hospitalet, Institut d'Investigacio Biomedica de Bellvitge, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Alejo', 'Initials': 'A', 'LastName': 'Rodriguez-Vida', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Trakya University, Edirne, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Harputluoglu', 'Affiliation': 'Inonu University, Malatya, Turkey.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Tagawa', 'Affiliation': 'New York-Presbyterian/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Ulka', 'Initials': 'U', 'LastName': 'Vaishampayan', 'Affiliation': 'Karmanos Cancer Institute, Detroit, MI, USA.'}, {'ForeName': 'Jeanny B', 'Initials': 'JB', 'LastName': 'Aragon-Ching', 'Affiliation': 'Inova Schar Cancer Institute, Fairfax, VA, USA.'}, {'ForeName': 'Oday', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Astra M', 'Initials': 'AM', 'LastName': 'Liepa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Wijayawardana', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Russo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Walgren', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Annamaria H', 'Initials': 'AH', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Hozak', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bell-McGuinn', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30668-0']
622,32217792,Real-time ultrasonography-magnetic resonance image fusion navigation for percutaneous transforaminal endoscopic discectomy.,"OBJECTIVE
Percutaneous transforaminal endoscopic discectomy (PTED) is usually performed under fluoroscopic guidance and is associated with a large radiation dose. Ultrasonography (US)-MR image fusion navigation combines the advantages of US and MRI and requires significantly less radiation than fluoroscopy. The purpose of this study was to evaluate the safety and effectiveness of US-MR image fusion navigation for PTED.
METHODS
From January to September 2018, patients with L4-5 lumbar disc herniation requiring PTED were randomized to have the procedure conducted with US-MR image fusion navigation or fluoroscopy. The number of fluoroscopies, radiation dose, duration of imaging guidance, intraoperative visual analog scale (VAS) pain score, intraoperative complications, and clinical outcomes were compared between the groups.
RESULTS
There were 10 patients in the US-MR navigation group and 10 in the fluoroscopy group, and there were no significant differences in age, sex ratio, or BMI between the 2 groups (all p > 0.05). Intraoperatively, the total radiation dose, number of fluoroscopies performed, duration of image guidance, and VAS low-back and leg pain scores were all significantly lower in the US-MRI navigation group than in the fluoroscopy group (all p < 0.05). There were no intraoperative complications in either group. Postoperative improvements in Japanese Orthopaedic Association, Oswestry Disability Index, and VAS pain scale scores were similar between the 2 groups.
CONCLUSIONS
US-MR image fusion navigation is a promising technology for performing PTED and requires significantly less radiation than fluoroscopy.Clinical trial registration no.: NCT03403244 (ClinicalTrials.gov).",2020,"CONCLUSIONS
US-MR image fusion navigation is a promising technology for performing PTED and requires significantly less radiation than fluoroscopy.","['From January to September 2018, patients with L4-5 lumbar disc herniation requiring PTED', 'percutaneous transforaminal endoscopic discectomy']","['Percutaneous transforaminal endoscopic discectomy (PTED', 'US-MR image fusion navigation or fluoroscopy', 'Ultrasonography', 'Real-time ultrasonography-magnetic resonance image fusion navigation']","['age, sex ratio, or BMI', 'total radiation dose, number of fluoroscopies performed, duration of image guidance, and VAS low-back and leg pain scores', 'number of fluoroscopies, radiation dose, duration of imaging guidance, intraoperative visual analog scale (VAS) pain score, intraoperative complications, and clinical outcomes', 'safety and effectiveness', 'Japanese Orthopaedic Association, Oswestry Disability Index, and VAS pain scale scores', 'intraoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc (disorder)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance procedure (procedure)'}, {'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",,0.0343639,"CONCLUSIONS
US-MR image fusion navigation is a promising technology for performing PTED and requires significantly less radiation than fluoroscopy.","[{'ForeName': 'Peigen', 'Initials': 'P', 'LastName': 'Xie', 'Affiliation': '1Departments of Spine Surgery.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': '1Departments of Spine Surgery.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': '2Ultrasound, and.'}, {'ForeName': 'Zihao', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': '1Departments of Spine Surgery.'}, {'ForeName': 'Bingjun', 'Initials': 'B', 'LastName': 'He', 'Affiliation': '3Radiology, The Third Affiliated Hospital of Sun Yat-sen University.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Kang', 'Affiliation': '3Radiology, The Third Affiliated Hospital of Sun Yat-sen University.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'He', 'Affiliation': '1Departments of Spine Surgery.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': '1Departments of Spine Surgery.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': '2Ultrasound, and.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': '2Ultrasound, and.'}, {'ForeName': 'Rongqin', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': '2Ultrasound, and.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Rong', 'Affiliation': '1Departments of Spine Surgery.'}]",Journal of neurosurgery. Spine,['10.3171/2020.1.SPINE191223']
623,31564451,Home-based records and vaccination appointment stickers as parental reminders to reduce vaccination dropout in Indonesia: A cluster-randomized controlled trial.,"INTRODUCTION
Limited evidence is available about the effectiveness of strategies to remind caregivers when to bring children back for future vaccinations in low- and middle-income country settings. We evaluated the effectiveness of two reminder strategies based on home-based vaccination records (HBR) in Indonesia.
METHODS
In this cluster-randomized controlled trial involving 3616 children <1 year of age, 90 health facilities were randomly assigned to either a control group or one of two intervention groups: (1) HBR-only group, where healthcare workers provided an HBR to any child without an HBR during a vaccination visit and instructed the caregiver to keep it at home between visits, or (2) HBR + sticker group, where, in addition to HBR provision, healthcare workers placed vaccination appointment reminder stickers on the HBR. The primary outcome was receipt of the third dose of diphtheria-tetanus-pertussis-containing vaccine (DTPcv3) within 7 months and the secondary outcome was receipt of a timely DTPcv3 dose.
RESULTS
Control group DTPcv3 coverage was 81%. In intention-to-treat analysis, neither intervention group had significantly different DTPcv3 coverage compared with the control group (RR = 0.94, 95% confidence interval [CI] 0.87; 1.02 for HBR-only group; RR = 0.97, 95% CI 0.90; 1.04 for HBR + sticker group) by study end. However, children in the HBR + sticker group were 50% more likely to have received a DTPcv3 vaccination (RR = 1.46, 95% CI 1.02, 2.09) within 60 days of DTPcv1 vaccination, compared with children in the control group; children in the HBR-only group were not more likely to have done so (RR = 1.05, 95% CI 0.71, 1.55).
DISCUSSION
Reminder stickers had an immediate effect on coverage by improving the proportion of children who received a timely DTPcv3 dose but no effect on the proportion who received DTPcv3 after 7 months. Coupling reminder stickers with strategies to address other reasons why children do not return for vaccination visits should be further explored.",2019,"In intention-to-treat analysis, neither intervention group had significantly different DTPcv3 coverage compared with the control group (RR = 0.94, 95% confidence interval [CI] 0.87; 1.02 for HBR-only group; RR = 0.97, 95% CI 0.90; 1.04 for HBR + sticker group) by study end.","['3616 children <1\u202fyear of age, 90 health facilities']","['HBR-only group, where healthcare workers provided an HBR to any child without an HBR during a vaccination visit and instructed the caregiver to keep it at home between visits, or (2) HBR\u202f+\u202fsticker group']","['DTPcv3 coverage', 'receipt of the third dose of diphtheria-tetanus-pertussis-containing vaccine (DTPcv3', 'DTPcv3 vaccination', 'receipt of a timely DTPcv3 dose']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",3616.0,0.191243,"In intention-to-treat analysis, neither intervention group had significantly different DTPcv3 coverage compared with the control group (RR = 0.94, 95% confidence interval [CI] 0.87; 1.02 for HBR-only group; RR = 0.97, 95% CI 0.90; 1.04 for HBR + sticker group) by study end.","[{'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Wallace', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, United States; Global Immunization Division, United States Centers for Disease Control and Prevention, Atlanta, GA, 30333, United States. Electronic address: awallace@cdc.gov.'}, {'ForeName': 'Kenny', 'Initials': 'K', 'LastName': 'Peetosutan', 'Affiliation': 'Maternal and Child Health Team, UNICEF, Jakarta, Indonesia.'}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Untung', 'Affiliation': 'Health Communications Team, Ministry of Health, Jakarta, Indonesia.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Ricardo', 'Affiliation': 'Maternal and Child Health Team, UNICEF, Addis Ababa, Ethiopia.'}, {'ForeName': 'Prima', 'Initials': 'P', 'LastName': 'Yosephine', 'Affiliation': 'National Immunization Program, Ministry of Health, Jakarta, Indonesia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wannemuehler', 'Affiliation': 'Global Immunization Division, United States Centers for Disease Control and Prevention, Atlanta, GA, 30333, United States.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Brown', 'Affiliation': 'Brown Consulting Group International LLC, Cornelius, NC, 28031, United States.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'McFarland', 'Affiliation': 'Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, United States.'}, {'ForeName': 'Walter A', 'Initials': 'WA', 'LastName': 'Orenstein', 'Affiliation': 'Division of Infectious Diseases, School of Medicine, Emory University, Atlanta, GA 30322, United States.'}, {'ForeName': 'Eli S', 'Initials': 'ES', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, University at Albany, State University of New York, Albany 12222, United States.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, United States.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Daniels', 'Affiliation': 'Global Immunization Division, United States Centers for Disease Control and Prevention, Atlanta, GA, 30333, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.09.040']
624,30916714,Efficacy and Tolerability of Adjunctive Intravenous Sodium Nitroprusside Treatment for Outpatients With Schizophrenia: A Randomized Clinical Trial.,"Importance
Antipsychotic medications for the treatment of schizophrenia have limitations, and new treatments are needed. A prior pilot investigation suggested that adjunctive sodium nitroprusside (SNP) administered intravenously had rapid efficacy in the treatment of patients with schizophrenia.
Objective
To determine the efficacy and tolerability of intravenous SNP infused at a rate of 0.5 μg/kg/min for 4 hours in patients with schizophrenia with some degree of treatment resistance.
Design, Setting, and Participants
Multicenter, randomized, double-blind acute treatment study using a sequential parallel comparison design conducted in two 2-week phases at 4 academic medical centers beginning May 20, 2015, and ending March 31, 2017. Participants were adults 18 to 65 years of age with a diagnosis of schizophrenia as confirmed by the Structured Clinical Interview for DSM-IV, taking antipsychotic medication for at least 8 weeks, and had at least 1 failed trial of an antipsychotic medication within the past year. A total of 90 participants consented, 60 participants enrolled, and 52 participants were included in the analyses. A modified intent-to-treat analysis was used.
Interventions
Participants were randomized in a 1:1:1 ratio to 1 of 3 treatment sequences: SNP and SNP, placebo and SNP, and placebo and placebo. The SNP and SNP group received SNP in phase 1 and SNP in phase 2 for the purpose of blinding, but the data from phase 2 were not included in the results. The placebo and SNP group received placebo in phase 1 and SNP in phase 2. If there was no response to placebo in phase 1, data from phase 2 were included in the analyses. The placebo and placebo group received placebo in both phases; if there was no response to placebo in phase 1, data from phase 2 were included in the analyses.
Main Outcomes and Measures
Effectiveness of SNP compared with placebo in improving Positive and Negative Syndrome Scale (PANSS) total, positive, and negative scores across each 2-week phase.
Results
Fifty-two participants (12 women and 40 men) were included in the study. In the SNP and SNP group, the mean (SD) age was 47.1 (10.5) years. In the placebo and SNP group, the mean (SD) age was 45.9 (12.3) years. In the placebo and placebo group, the mean (SD) age was 40.4 (11.0) years. There were no significant differences between the SNP and placebo groups at baseline or in change from baseline for PANSS-total (weighted β = -1.04; z = -0.59; P = .57), PANSS-positive (weighted β = -0.62; z = -0.93; P = .35), or PANSS-negative (weighted β = -0.12; z = -0.19; P = .85) scores. No significant differences in safety or tolerability measures were identified.
Conclusions and Relevance
Although intravenous SNP is well tolerated, it was not an efficacious adjunctive treatment of positive or negative symptoms of psychosis among outpatients with schizophrenia with prior history of treatment resistance.
Trial Registration
ClinicalTrials.gov identifier: NCT02164981.",2019,"There were no significant differences between the SNP and placebo groups at baseline or in change from baseline for PANSS-total (weighted β = -1.04; z = -0.59; P = .57), PANSS-positive (weighted β = -0.62; z = -0.93; P = .35), or PANSS-negative (weighted β = -0.12; z = -0.19; P = .85) scores.","['Fifty-two participants (12 women and 40 men', 'Outpatients With Schizophrenia', 'Participants were adults 18 to 65 years of age with a diagnosis of schizophrenia as confirmed by the Structured Clinical Interview for DSM-IV, taking antipsychotic medication for at least 8 weeks, and had at least 1 failed trial of an antipsychotic medication within the past year', 'outpatients with schizophrenia with prior history of treatment resistance', 'two 2-week phases at 4 academic medical centers beginning May 20, 2015, and ending March 31, 2017', 'A total of 90 participants consented, 60 participants enrolled, and 52 participants were included in the analyses', 'patients with schizophrenia with some degree of treatment resistance', 'patients with schizophrenia']","['placebo', 'adjunctive sodium nitroprusside (SNP', 'Adjunctive Intravenous Sodium Nitroprusside Treatment', 'SNP and SNP, placebo and SNP, and placebo and placebo', 'intravenous SNP', 'SNP']","['safety or tolerability measures', 'Positive and Negative Syndrome Scale (PANSS) total, positive, and negative scores', 'Efficacy and Tolerability', 'efficacy and tolerability']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.278782,"There were no significant differences between the SNP and placebo groups at baseline or in change from baseline for PANSS-total (weighted β = -1.04; z = -0.59; P = .57), PANSS-positive (weighted β = -0.62; z = -0.93; P = .35), or PANSS-negative (weighted β = -0.12; z = -0.19; P = .85) scores.","[{'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Freudenreich', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Xiaoduo', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Psychiatry, UMass Memorial Health Care and UMass Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Stephen O', 'Initials': 'SO', 'LastName': 'Heard', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, UMass Memorial Health Care and UMass Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Goff', 'Affiliation': 'Department of Psychiatry, NYU Langone Medical Center, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Petrides', 'Affiliation': 'Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Harrington', 'Affiliation': 'Department of Psychiatry, UMass Memorial Health Care and UMass Medical School, Worcester, Massachusetts.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Roy H', 'Initials': 'RH', 'LastName': 'Perlis', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.0151']
625,31082417,Feasibility and effects of galantamine on cognition in humans with cannabis use disorder.,"BACKGROUND
As long-term use of medicinal and recreational cannabis becomes more common and concentrations of delta-9-tetrahydrocannabinol (THC) in cannabis increase, it is timely to identify strategies to counteract the cognitive effects of cannabinoids.
OBJECTIVE
Galantamine is an acetylcholinesterase inhibitor approved for the treatment of Alzheimer's disease and other dementias. This study aimed to investigate the feasibility of galantamine administration to individuals with cannabis use disorder (CUD), and the effects of galantamine on cognition. We hypothesized galantamine would be well tolerated and would not have procognitive effects in the absence of acute cannabis intoxication.
METHODS
Thirty individuals with CUD (73.5% male, 26.5% female) participated in a randomized, double-blind, parallel-group trial. Participants completed a baseline session followed by a 10-day outpatient treatment period, during which they received either 8 mg/day of galantamine orally or placebo. Cognitive assessments were conducted at three time points and self-reported measures that may impact cognitive performance (cannabis withdrawal, craving, and mood) were completed at six time points.
RESULTS
There were no significant differences in demographic and baseline variables between groups (galantamine vs. placebo). There were no significant adverse effects from galantamine. Cannabis withdrawal and craving continuously decreased over the study. We saw evidence of a modest improvement in cognitive outcomes during the 10-day period, exemplified by a statistically significant increase in measures of response inhibition (increased median reaction time on the Stop Signal Task), and a trend for improvement in measures of attention (increased RVP A'), for both groups. Analyses did not show, however, a significant main effect for treatment or treatment-by-time interactions.
CONCLUSIONS
The findings of this pilot study support the feasibility of the administration of galantamine for individuals with CUD. Adequately powered, randomized, placebo-controlled trials are required to investigate the potential of galantamine to improve cognitive deficits associated with CUD.",2019,There were no significant adverse effects from galantamine.,"['humans with cannabis use disorder', 'Thirty individuals with CUD (73.5% male, 26.5% female', 'individuals with cannabis use disorder (CUD', 'individuals with CUD']","['delta-9-tetrahydrocannabinol', 'placebo', 'galantamine', 'galantamine orally or placebo', 'Galantamine', 'galantamine vs. placebo']","['cognitive outcomes', 'Cannabis withdrawal and craving continuously', 'response inhibition', 'impact cognitive performance (cannabis withdrawal, craving, and mood']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}]","[{'cui': 'C3840212', 'cui_str': 'Cannabis withdrawal (disorder)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",30.0,0.265107,There were no significant adverse effects from galantamine.,"[{'ForeName': 'Dawn E', 'Initials': 'DE', 'LastName': 'Sugarman', 'Affiliation': 'Division of Alcohol and Drug Abuse, 115 Mill Street, McLean Hospital, Belmont 02478, MA, United States; Harvard Medical School, 25 Shattuck Street, Boston 02115, MA, United States. Electronic address: dsugarman@mclean.harvard.edu.'}, {'ForeName': 'Joao P', 'Initials': 'JP', 'LastName': 'De Aquino', 'Affiliation': 'VA Connecticut Healthcare System, 950 Campbell Ave., Bldg. 36/116A4, West Haven, CT 06516, USA; Yale University School of Medicine, Department of Psychiatry, 300 George St., New Haven, CT 06511, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Poling', 'Affiliation': 'Yale University School of Medicine, Department of Psychiatry, 300 George St., New Haven, CT 06511, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'VA Connecticut Healthcare System, 950 Campbell Ave., Bldg. 36/116A4, West Haven, CT 06516, USA; Yale University School of Medicine, Department of Psychiatry, 300 George St., New Haven, CT 06511, USA.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2019.05.004']
626,31329516,"ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer.","PURPOSE
Enzalutamide, a potent androgen-receptor inhibitor, has demonstrated significant benefits in metastatic and nonmetastatic castration-resistant prostate cancer. We evaluated the efficacy and safety of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC).
METHODS
ARCHES (ClinicalTrials.gov identifier: NCT02677896) is a multinational, double-blind, phase III trial, wherein 1,150 men with mHSPC were randomly assigned 1:1 to enzalutamide (160 mg/day) or placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and prior docetaxel chemotherapy. The primary end point was radiographic progression-free survival.
RESULTS
As of October 14, 2018, the risk of radiographic progression or death was significantly reduced with enzalutamide plus ADT versus placebo plus ADT (hazard ratio, 0.39; 95% CI, 0.30 to 0.50; P < .001; median not reached v 19.0 months). Similar significant improvements in radiographic progression-free survival were reported in prespecified subgroups on the basis of disease volume and prior docetaxel therapy. Enzalutamide plus ADT significantly reduced the risk of prostate-specific antigen progression, initiation of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, and reduced risk of pain progression. More men achieved an undetectable prostate-specific antigen level and/or an objective response with enzalutamide plus ADT ( P < .001). Patients in both treatment groups reported a high baseline level of quality of life, which was maintained over time. Grade 3 or greater adverse events were reported in 24.3% of patients who received enzalutamide plus ADT versus 25.6% of patients who received placebo plus ADT, with no unexpected adverse events.
CONCLUSION
Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.",2019,"Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.","['Men With Metastatic Hormone-Sensitive Prostate Cancer', 'metastatic and nonmetastatic castration-resistant prostate cancer', 'metastatic hormone-sensitive prostate cancer (mHSPC', '1,150 men with mHSPC']","['placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and prior docetaxel chemotherapy', 'enzalutamide plus ADT', 'Enzalutamide plus ADT', 'placebo plus ADT', 'enzalutamide', 'Androgen Deprivation Therapy With Enzalutamide or Placebo', 'Enzalutamide with ADT', 'ARCHES']","['risk of prostate-specific antigen progression, initiation of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, and reduced risk of pain progression', 'undetectable prostate-specific antigen level', 'radiographic progression-free survival', 'risk of metastatic progression or death', 'Grade 3 or greater adverse events', 'efficacy and safety', 'risk of radiographic progression or death', 'high baseline level of quality of life']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0003392', 'cui_str': 'Chemotherapeutic Anticancer Drug'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0034380'}]",1150.0,0.334023,"Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC.'}, {'ForeName': 'Russell Z', 'Initials': 'RZ', 'LastName': 'Szmulewitz', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Holzbeierlein', 'Affiliation': 'The University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Lille University, Lille, France.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Azad', 'Affiliation': 'Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Alcaraz', 'Affiliation': 'Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'Hertzen Moscow Cancer Research Institute, Moscow, Russia.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Iguchi', 'Affiliation': 'Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Rosbrook', 'Affiliation': 'Pfizer, San Diego, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'Astellas Pharma, Northbrook, IL.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Baron', 'Affiliation': 'Astellas Pharma, Leiden, the Netherlands.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Astellas Pharma, Northbrook, IL.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00799']
627,32209798,Effect of 12-Week Interventions Involving Nordic Walking Exercise and a Modified Diet on the Anthropometric Parameters and Blood Lipid Profiles in Overweight and Obese Ex-Coal Miners.,"BACKGROUND
Overweight and obesity after retirement are likely to be caused by unhealthy eating habits and the energy intake exceeding the energy expenditure.
OBJECTIVES
This study was designed to assess the effects of two 12-week interventions involving, respectively, either regular physical activity or a modified lower-calorie diet on the anthropometric parameters and blood lipid profiles in overweight and obese retired miners with lipid disorders.
DESIGN
The study participants (n = 30, aged 58.7 ± 4.1 years, body height 174.8 ± 7.3 cm, body weight 96.6 ± 13.9 kg) were randomly assigned to 2 intervention groups: the Nordic walking group (NW), which exercised with intensity from 60 to 70% of participants' maximal heart rates for 1 h 3 times a week, and the modified diet group (MD). Modification of the diet consisted of reducing the daily energy intake by 30%, increasing the dietary content of mono- and polyunsaturated fatty acids and dietary fiber, and reducing the proportion of saturated fatty acids. The variables assessed at baseline and after 6 and 12 weeks were: anthropometric parameters (body weight, fat mass content [FM], fat percentage [BF], BMI, waist circumference [WC], hip circumference [HC], and waist-to-hip ratio [WHR]) and blood lipid indicators (total cholesterol [TC], triglycerides [TG], low density lipoprotein cholesterol [LDL-C], and high density lip-oprotein cholesterol [HDL-C]).
RESULTS
The body weight of the participants in the NW was lower at week 12 by an average of 5 kg, BMI by 6%, FB by 19%, FM by 15%, WC by 8%, HC by 6%, and WHR by 3%. In the MD, the respective decreases were 8 kg and 8, 25, 20, 6, 2, and 7%. In the MD, the postintervention concentrations of TC and TG were within the reference range.
CONCLUSION
Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.",2020,"Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.","['body weight 96.6 ± 13.9 kg', 'Overweight and Obese Ex-Coal Miners', 'overweight and obese retired miners with lipid disorders', 'The study participants (n = 30, aged 58.7 ± 4.1 years, body height 174.8 ± 7.3 cm']","['Nordic walking group (NW', 'regular physical activity or a modified lower-calorie diet', 'Nordic Walking Exercise and a Modified Diet']","['body weight', 'anthropometric parameters (body weight, fat mass content [FM], fat percentage [BF], BMI, waist circumference [WC], hip circumference [HC], and waist-to-hip ratio [WHR]) and blood lipid indicators (total cholesterol [TC], triglycerides [TG], low density lipoprotein cholesterol [LDL-C], and high density lip-oprotein cholesterol [HDL-C', 'anthropometric parameters and blood lipid profiles', 'postintervention concentrations of TC and TG']","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0341671', 'cui_str': 'Coal miner (occupation)'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0240346', 'cui_str': 'Mineworkers'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005890', 'cui_str': 'Body Height'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0452264', 'cui_str': 'Therapeutic diets (finding)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264657', 'cui_str': 'Mass content'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.014178,"Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.","[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland, e.sadowska-krepa@awf.katowice.pl.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Gdańska', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Rozpara', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Pilch', 'Affiliation': 'Department of Biochemistry and Basic of Cosmetology, University School of Physical Education, Krakow, Poland.'}, {'ForeName': 'Miroslava', 'Initials': 'M', 'LastName': 'Přidalová', 'Affiliation': 'Department of Natural Sciences in Kinanthropology, Faculty of Physical Culture, Palacký University, Olomouc, Czechia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bańkowski', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}]",Obesity facts,['10.1159/000506403']
628,31575423,Comparison of Frequency of Atherosclerotic Cardiovascular Disease Events Among Primary and Secondary Prevention Subgroups of the Systolic Blood Pressure Intervention Trial.,"The Pooled Cohort Equation (PCE) predicts 10-year risk of first-time atherosclerotic cardiovascular disease (ASCVD) events and was incorporated in analyses of a primary and secondary prevention population in the Systolic Blood Pressure Intervention Trial (SPRINT). Whether PCE enhances risk prediction among secondary prevention populations is unknown. We sought to compare ASCVD events by level of PCE-predicted risk among primary and secondary prevention SPRINT populations. SPRINT randomized adults with hypertension and ≥1 CVD risk factor or previous CVD events to systolic blood pressure control targeting <120 mm Hg or 135 to 139 mm Hg. We calculated the hazard ratio (HR) of ASCVD events among secondary versus primary (reference) prevention subgroups overall and by predicted 10-year ASCVD risk categories (<10%, 10% to <20%, 20% to <30%, and ≥30%) and within risk subgroups, comparing to the lowest risk category. Among 8,151 participants, 16% with previous CVD, mean age was 66 years and 35% were women. The HR for ASCVD events overall was 2.51 (1.96, 3.20). HR was 2.97 (1.47, 5.99) among <10% 10-year risk and 2.23 (1.38, 3.59) among ≥30% risk. Within subgroups comparing ≥30% to <10% risk (reference) categories, the HR was 2.85 (1.76, 4.63) for primary and 2.14 (1.07, 4.30) for the secondary prevention. In conclusion, history of previous events was a potent risk factor for subsequent ASCVD events. The PCE does not enhance risk prediction among secondary prevention populations and may differentially underestimate risk in secondary prevention populations with lowest predicted risk.",2019,The PCE does not enhance risk prediction among secondary prevention populations and may differentially underestimate risk in secondary prevention populations with lowest predicted risk.,"['Primary and Secondary Prevention Subgroups of the Systolic Blood Pressure Intervention Trial', '8,151 participants, 16% with previous CVD, mean age was 66 years and 35% were women', 'SPRINT randomized adults with hypertension and ≥1 CVD risk factor or previous CVD events to systolic blood pressure control targeting <120 mm Hg or 135 to 139 mm Hg']",['PCE'],"['hazard ratio (HR) of ASCVD events', '10-year ASCVD risk categories']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C1588205', 'cui_str': 'PCE'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0342558,The PCE does not enhance risk prediction among secondary prevention populations and may differentially underestimate risk in secondary prevention populations with lowest predicted risk.,"[{'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont. Electronic address: Timothy.Plante@uvm.edu.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Zakai', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont; Department Pathology and Laboratory Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Department Pathology and Laboratory Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cushman', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont; Department Pathology and Laboratory Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.08.028']
629,30982604,"Association between testosterone, semen parameters, and live birth in men with unexplained infertility in an intrauterine insemination population.","OBJECTIVE
To determine whether men with unexplained infertility and low total T (TT) have abnormal spermatogenesis and lower fecundity.
DESIGN
Secondary analysis of the prospective, randomized, multicenter clinical trial, Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS).
SETTING
Infertility clinics.
PATIENT(S)
Nine hundred couples with unexplained infertility enrolled in AMIGOS. Semen analysis with an ejaculate of at least 5 million total motile sperm was required for enrollment. For inclusion in this secondary analysis, a fasting TT was required.
INTERVENTION(S)
None.
MAIN OUTCOME MEASURE(S)
Logistic regression, adjusted for age and body mass index, assessed the association between low TT (defined as <264 ng/dL), semen parameters, and pregnancy outcome.
RESULT(S)
Seven hundred eighty-one men (mean age, 34.2 ± 5.7 years) with a median (interquartile range) TT of 411 (318-520) ng/dL were included. Men with TT <264 ng/dL were less likely to have normal (≥4% strict Kruger) morphology (unadjusted odds ratio [OR], 0.56; 95% confidence interval [CI], 0.34, 0.92; adjusted OR, 0.59; 95% CI, 0.35, 0.99). There was no association between low TT and semen volume < 1.5 mL, sperm concentration < 15 × 10 6 /mL, or motility < 40%. Among couples whose male partner had low TT, 21 (18.8%) had a live birth, compared with 184 (27.5%) live births in couples with a male partner having TT > 264 ng/dL. The odds of live birth decreased by 40% in couples whose male partner had low TT (unadjusted OR, 0.60; 95% CI, 0.36, 1.00; adjusted OR, 0.65; 95% CI, 0.38, 1.12).
CONCLUSION(S)
In couples with unexplained infertility, low TT in the male partner was associated with abnormal sperm morphology and lower live birth rates.
CLINICAL TRIAL REGISTRATION NUMBER
NCT01044862.",2019,"There was no association between low TT and semen volume < 1.5 mL, sperm concentration < 15 × 10 6 /mL, or motility < 40%.","['\n\n\nNine hundred couples with unexplained infertility enrolled in AMIGOS', 'men with unexplained infertility and low total T (TT) have abnormal spermatogenesis and lower fecundity', '\n\n\nSeven hundred eighty-one men (mean age, 34.2 ± 5.7\xa0years) with a median (interquartile range', 'Infertility clinics', 'Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS', 'men with unexplained infertility in an intrauterine insemination population', '264']",[],"['live birth', 'odds of live birth', 'sperm concentration', 'abnormal sperm morphology and lower live birth rates']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0520933', 'cui_str': 'Abnormal spermatogenesis (disorder)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3715200', 'cui_str': 'Infertility clinic'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0428011', 'cui_str': 'Sperm morphology (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",900.0,0.54804,"There was no association between low TT and semen volume < 1.5 mL, sperm concentration < 15 × 10 6 /mL, or motility < 40%.","[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Trussell', 'Affiliation': 'Department of Urology, Upstate University Hospital, Syracuse, New York. Electronic address: jctrussell1@verizon.net.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Coward', 'Affiliation': 'Department of Urology, UNC School of Medicine, Chapel Hill, North Carolina; UNC Fertility, Raleigh, North Carolina.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Stetter', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Kunselman', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, Georgia.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology and Molecular Medicine and Genetics, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Heisenleder', 'Affiliation': 'Ligand Assay and Analysis Core, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Steiner', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wild', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Partner of Northeastern Reproductive Medicine, Colchester, Vermont.'}, {'ForeName': 'Cristos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Phildelphia, Pennsylvania.'}, {'ForeName': 'Reuben R', 'Initials': 'RR', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, Women and Infants Hospital, Providence, Rhode Island.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Robinson', 'Affiliation': 'University of Texas Health Science Center, San Antonio, San Antonio, Texas.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Patrizio', 'Affiliation': 'Yale Fertility Center, New Haven, Connecticut.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Lindgren', 'Affiliation': 'Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2019.01.034']
630,31320010,Ablation in Persistent Atrial Fibrillation Using Stochastic Trajectory Analysis of Ranked Signals (STAR) Mapping Method.,"OBJECTIVES
The aim of this study was to demonstrate that a stochastic vector-based mapping approach could guide ablation of atrial fibrillation (AF) drivers as evidenced by ablation response and long-term follow-up outcomes.
BACKGROUND
The optimal method for mapping and ablation of AF drivers is yet to be defined.
METHODS
Patients undergoing persistent AF ablation were recruited. Patients underwent pulmonary vein isolation (PVI) with further ablation guided by the stochastic trajectory analysis of ranked signals (STAR) mapping method. The proportion of the time an electrode's activation was seen to precede its neighboring electrodes activation was used to determine early sites of activation (ESA). A positive ablation response at ESA was defined as AF termination or cycle length slowing of ≥30 ms. Clinical outcome was defined as recurrence of AF/atrial tachycardia (AT) during a follow-up of 12 months.
RESULTS
Thirty-five patients were included (AF duration of 14.4 ± 5.3 months). After PVI, an average of 2.6 ± 0.8 ESA were ablated per patient with study-defined ablation response achieved in all patients. Of the 86 STAR maps created post-PVI, the same ESA was identified on 73.8 ± 26.1% of maps. ESA that resulted in AF termination were more likely to be identified on both pre- and post-PVI maps than those associated with cycle length slowing (23 of 24 vs. 16 of 49; p < 0.001). During a follow-up of 18.5 ± 3.7 months, 28 (80%) patients were free from AF/AT.
CONCLUSIONS
The ablation response at ESA suggests they may be drivers of AF. Ablation guided by STAR mapping produced a favorable clinical outcome and warrants testing through a randomized controlled trial. (Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation [STAR MAPPING]; NCT02950844).",2019,ESA that resulted in AF termination were more likely to be identified on both pre- and post-PVI maps than those associated with cycle length slowing (23 of 24 vs. 16 of 49; p < 0.001).,"['Thirty-five patients were included (AF duration of 14.4 ± 5.3\xa0months', 'Patients undergoing persistent AF ablation were recruited']","['Ablation guided by STAR mapping', 'ESA', 'stochastic vector-based mapping approach', 'pulmonary vein isolation (PVI) with further ablation guided by the stochastic trajectory analysis of ranked signals (STAR) mapping method']","['AF termination', 'recurrence of AF/atrial tachycardia (AT', 'ablation response']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",35.0,0.0341331,ESA that resulted in AF termination were more likely to be identified on both pre- and post-PVI maps than those associated with cycle length slowing (23 of 24 vs. 16 of 49; p < 0.001).,"[{'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Honarbakhsh', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Ross J', 'Initials': 'RJ', 'LastName': 'Hunter', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Ullah', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Keating', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Finlay', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Schilling', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom. Electronic address: richard.schilling@bartshealth.nhs.uk.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.04.007']
631,32215634,"Association of Race and Ethnicity With Late-Life Depression Severity, Symptom Burden, and Care.","Importance
Knowledge gaps persist regarding racial and ethnic variation in late-life depression, including differences in specific depressive symptoms and disparities in care.
Objective
To examine racial/ethnic differences in depression severity, symptom burden, and care.
Design, Setting, and Participants
This cross-sectional study included 25 503 of 25 871 community-dwelling older adults who participated in the Vitamin D and Omega-3 Trial (VITAL), a randomized trial of cancer and cardiovascular disease prevention conducted from November 2011 to December 2017. Data analysis was conducted from June to September 2018.
Exposure
Racial/ethnic group (ie, non-Hispanic white; black; Hispanic; Asian; and other, multiple, or unspecified race).
Main Outcomes and Measures
Depressive symptoms, assessed using the Patient Health Questionnaire-8 (PHQ-8); participant-reported diagnosis, medication, and/or counseling for depression. Differences across racial/ethnic groups were evaluated using multivariable zero-inflated negative binomial regression to compare PHQ-8 scores and multivariable logistic regression to estimate odds of item-level symptom burden and odds of depression treatment among those with diagnosed depression.
Results
There were 25 503 VITAL participants with adequate depression data (mean [SD] age, 67.1 [7.1] years) including 12 888 [50.5%] women, 17 828 [69.9%] non-Hispanic white participants, 5004 [19.6%] black participants, 1001 [3.9%] Hispanic participants, 377 [1.5%] Asian participants, and 1293 participants [5.1%] who were categorized in the other, multiple, or unspecified race group. After adjustment for sociodemographic, lifestyle, and health confounders, black participants had a 10% higher severity level of PHQ-8 scores compared with non-Hispanic white participants (rate ratio [RR], 1.10; 95% CI, 1.04-1.17; P < .001); Hispanic participants had a 23% higher severity level of PHQ-8 scores compared with non-Hispanic white participants (RR, 1.23; 95% CI, 1.10-1.38; P < .001); and participants in the other, multiple, or unspecified group had a 14% higher severity level of PHQ-8 scores compared with non-Hispanic white participants (RR, 1.14; 95% CI, 1.04-1.25; P = .007). Compared with non-Hispanic white participants, participants belonging to minority groups had 1.5-fold to 2-fold significantly higher fully adjusted odds of anhedonia (among black participants: odds ratio [OR], 1.76; 95% CI, 1.47-2.11; among Hispanic participants: OR, 1.96; 95% CI, 1.43-2.69), sadness (among black participants: OR, 1.31; 95% CI, 1.07-1.60; among Hispanic participants: OR, 2.09; 95% CI, 1.51-2.88), and psychomotor symptoms (among black participants: OR, 1.77; 95% CI, 1.31-2.39; among Hispanic participants: OR, 2.12; 95% CI, 1.28-3.50); multivariable-adjusted odds of sleep problems and guilt appeared higher among Hispanic vs non-Hispanic white participants (sleep: OR, 1.24; 95% CI, 1.01-1.52; guilt: 1.84; 95% CI, 1.31-2.59). Among those with clinically significant depressive symptoms (ie, PHQ-8 score ≥10) and/or those with diagnosed depression, black participants were 61% less likely to report any treatment (ie, medications and/or counseling) than non-Hispanic white participants after adjusting for confounders (adjusted OR, 0.39; 95% CI, 0.27-0.56).
Conclusions and Relevance
In this cross-sectional study, significant racial and ethnic differences in late-life depression severity, item-level symptom burden, and depression care were observed after adjustment for numerous confounders. These findings suggest a need for further examination of novel patient-level and clinician-level factors underlying these associations.",2020,"Compared with non-Hispanic white participants, participants belonging to minority groups had 1.5-fold to 2-fold significantly higher fully adjusted odds of anhedonia (among black participants: odds ratio [OR], 1.76; 95% CI, 1.47-2.11; among Hispanic participants: OR, 1.96; 95% CI, 1.43-2.69), sadness (among black participants: OR, 1.31; 95% CI, 1.07-1.60; among Hispanic participants: OR, 2.09; 95% CI, 1.51-2.88), and psychomotor symptoms (among black participants: OR, 1.77; 95% CI, 1.31-2.39; among Hispanic participants: OR, 2.12; 95% CI, 1.28-3.50); multivariable-adjusted odds of sleep problems and guilt appeared higher among Hispanic vs non-Hispanic white participants (sleep: OR, 1.24; 95% CI, 1.01-1.52; guilt: 1.84; 95% CI, 1.31-2.59).","['There were 25\u202f503 VITAL participants with adequate depression data (mean [SD] age, 67.1 [7.1] years) including 12\u202f888 [50.5%] women, 17\u202f828 [69.9%] non-Hispanic white participants, 5004 [19.6%] black participants, 1001 [3.9%] Hispanic participants, 377 [1.5%] Asian participants, and 1293 participants [5.1%] who were categorized in the other, multiple, or unspecified race group', 'Participants\n\n\nThis cross-sectional study included 25\u202f503 of 25\u202f871 community-dwelling older adults who participated in the Vitamin D and Omega-3 Trial (VITAL), a randomized trial of cancer and cardiovascular disease prevention conducted from November 2011 to December 2017']",[],"['late-life depression severity, item-level symptom burden, and depression care', 'severity level of PHQ-8 scores', 'anhedonia', 'Measures\n\n\nDepressive symptoms, assessed using the Patient Health Questionnaire-8 (PHQ-8); participant-reported diagnosis, medication, and/or counseling for depression', 'depression severity, symptom burden, and care', 'psychomotor symptoms', 'depressive symptoms']","[{'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],"[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}]",25503.0,0.25102,"Compared with non-Hispanic white participants, participants belonging to minority groups had 1.5-fold to 2-fold significantly higher fully adjusted odds of anhedonia (among black participants: odds ratio [OR], 1.76; 95% CI, 1.47-2.11; among Hispanic participants: OR, 1.96; 95% CI, 1.43-2.69), sadness (among black participants: OR, 1.31; 95% CI, 1.07-1.60; among Hispanic participants: OR, 2.09; 95% CI, 1.51-2.88), and psychomotor symptoms (among black participants: OR, 1.77; 95% CI, 1.31-2.39; among Hispanic participants: OR, 2.12; 95% CI, 1.28-3.50); multivariable-adjusted odds of sleep problems and guilt appeared higher among Hispanic vs non-Hispanic white participants (sleep: OR, 1.24; 95% CI, 1.01-1.52; guilt: 1.84; 95% CI, 1.31-2.59).","[{'ForeName': 'Chirag M', 'Initials': 'CM', 'LastName': 'Vyas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Macarius', 'Initials': 'M', 'LastName': 'Donneyong', 'Affiliation': 'College of Pharmacy, The Ohio State University, Columbus.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, VA Boston Healthcare System, Brockton, Massachusetts.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Gibson', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Olivia I', 'Initials': 'OI', 'LastName': 'Okereke', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1606']
632,31618129,Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer.,"PURPOSE
We evaluated the addition of bevacizumab, a humanized monoclonal antibody that targets vascular endothelial growth factor, to platinum-based chemotherapy in recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
PATIENTS AND METHODS
Patients with chemotherapy-naïve (or with prior platinum as part of multimodal therapy completed ≥ 4 months earlier) recurrent or metastatic SCCHN were randomly assigned to receive a platinum-based chemotherapy doublet with or without bevacizumab 15 mg/kg given intravenously every 3 weeks until disease progression. Chemotherapy could be discontinued after six cycles if a maximum response was achieved.
RESULTS
The study randomly assigned 403 patients. Median overall survival (OS) was 12.6 months with bevacizumab plus chemotherapy (BC) and 11.0 months with chemotherapy alone (hazard ratio, 0.87; 95% CI, 0.70 to 1.09; P = .22). At 2, 3, and 4 years, the OS rates were 25.2% v 18.1%, 16.4% v 10.0%, and 11.8% v 6.4% for BC versus chemotherapy, respectively. In an analysis of 365 eligible patients who started treatment, the hazard ratio was 0.82 (95% CI, 0.65 to 1.04; P = .10), with a median OS of 14.2 months on BC v 11.1 months on chemotherapy. Median progression-free survival with BC was 6.0 months v 4.3 months with chemotherapy ( P = .0014). Overall response rates were 35.5% with BC and 24.5% with chemotherapy ( P = .016). There was increased toxicity, including a higher rate of treatment-related grade 3 to 5 bleeding events (6.7% v 0.5%; P < .001) and treatment-related deaths (9.3% v 3.5%; P = .022) with BC versus chemotherapy.
CONCLUSION
The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities. These results encourage biomarker-driven studies of angiogenesis inhibitors with better toxicity profiles in select patients with SCCHN.",2019,The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities.,"['403 patients', 'Patients With Recurrent or Metastatic Head and Neck Cancer', 'select patients with SCCHN', 'recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN', 'Patients with chemotherapy-naïve (or with prior platinum as part of multimodal therapy completed ≥ 4 months earlier', 'recurrent or metastatic SCCHN']","['platinum-based chemotherapy', 'platinum-based chemotherapy doublet with or without bevacizumab', 'bevacizumab plus chemotherapy (BC', 'bevacizumab', 'Chemotherapy With or Without Bevacizumab', 'Chemotherapy']","['treatment-related deaths', 'response rate and progression-free survival with increased toxicities', 'higher rate of treatment-related grade 3 to 5 bleeding events', 'toxicity', 'Overall response rates', 'Median overall survival (OS', 'OS rates', 'hazard ratio', 'Median progression-free survival with BC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",403.0,0.094703,The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities.,"[{'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Argiris', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Panayiotis', 'Initials': 'P', 'LastName': 'Savvides', 'Affiliation': 'University of Arizona Cancer Center, Phoenix, AZ.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Ohr', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Marshall A', 'Initials': 'MA', 'LastName': 'Levine', 'Affiliation': 'Greater Baltimore Medical Center, Baltimore, MD.'}, {'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Chakravarti', 'Affiliation': 'The Ohio State University Medical School, Columbus, OH.'}, {'ForeName': 'Missak', 'Initials': 'M', 'LastName': 'Haigentz', 'Affiliation': 'Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Chukwuemeka V', 'Initials': 'CV', 'LastName': 'Ikpeazu', 'Affiliation': 'University of Miami, Miami, FL.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Schneider', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Harlan A', 'Initials': 'HA', 'LastName': 'Pinto', 'Affiliation': 'Stanford University Medical Center, Stanford, CA.'}, {'ForeName': 'Arlene A', 'Initials': 'AA', 'LastName': 'Forastiere', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00555']
633,30919549,Clinical factors related to morbidity and mortality in high-risk heart failure patients: the GUIDE-IT predictive model and risk score.,"BACKGROUND
Most heart failure (HF) risk scores have been derived from cohorts of stable HF patients and may not incorporate up to date treatment regimens or deep phenotype characterization that change baseline risk over the short- and long-term follow-up period. We undertook the current analysis of participants in the GUIDE-IT (Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment) trial to address these limitations.
METHODS AND RESULTS
The GUIDE-IT study randomized 894 high-risk patients with HF and reduced ejection fraction (≤ 40%) to biomarker-guided treatment strategy vs. usual care. We performed risk modelling using Cox proportional hazards models and analysed the relationship between 35 baseline clinical factors and the primary composite endpoint of cardiovascular (CV) death or HF hospitalization, the secondary endpoint of all-cause mortality, and the exploratory endpoint of 90-day HF hospitalization or death. Prognostic relationships for continuous variables were examined and key predictors were identified using a backward variable selection process. Predictive models and risk scores were developed. Over a median follow-up of 15 months, the cumulative number of HF hospitalizations and CV deaths was 328 out of 894 patients (Kaplan-Meier event rate 34.5% at 12 months). Frequency of all-cause deaths was 143 out of 894 patients (Kaplan-Meier event rate 12.2% at 12 months). Outcomes for the primary and secondary endpoints between strategy arms of the study were similar. The most important predictor that was present in all three models was the baseline natriuretic peptide level. Hispanic ethnicity, low sodium and high heart rate were present in two of the three models. Other important predictors included the presence or absence of a device, New York Heart Association class, HF duration, black race, co-morbidities (sleep apnoea, elevated creatinine, ischaemic heart disease), low blood pressure, and a high congestion score.
CONCLUSION
Risk models using readily available clinical information are able to accurately predict short- and long-term CV events and may be useful in optimizing care and enriching patients for clinical trials.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov ID number NCT01685840.",2019,Frequency of all-cause deaths was 143 out of 894 patients (Kaplan-Meier event rate 12.2% at 12 months).,"['high-risk heart failure patients', '894 high-risk patients with HF and reduced ejection fraction (≤ 40%) to biomarker-guided treatment strategy vs. usual care']",[],"['cumulative number of HF hospitalizations and CV deaths', 'Hispanic ethnicity, low sodium and high heart rate', 'presence or absence of a device, New York Heart Association class, HF duration, black race, co-morbidities (sleep apnoea, elevated creatinine, ischaemic heart disease), low blood pressure, and a high congestion score', 'cardiovascular (CV) death or HF hospitalization, the secondary endpoint of all-cause mortality, and the exploratory endpoint of 90-day HF hospitalization or death', 'Frequency of all-cause deaths']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0700148', 'cui_str': 'Congestion (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",894.0,0.0891078,Frequency of all-cause deaths was 143 out of 894 patients (Kaplan-Meier event rate 12.2% at 12 months).,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Fairfax, VA, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Section of Cardiovascular Medicine and Center for Outcomes Research, Yale University School of Medicine New Haven, New Haven, CT, United States.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada; Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kirkwood F', 'Initials': 'KF', 'LastName': 'Adams', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Lawton S', 'Initials': 'LS', 'LastName': 'Cooper', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Department of Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}]",European journal of heart failure,['10.1002/ejhf.1450']
634,31145919,"Food craving, cortisol and ghrelin responses in modeling highly palatable snack intake in the laboratory.","Overeating of highly palatable (HP) foods in the ubiquitous HP food cue environment and under stress is associated with weight gain and contributes to the global obesity epidemic. However, subjective and biobehavioral processes that may increase HP overeating are not clear. Using a novel experimental approach, we examined HP food motivation and intake and neuroendocrine responses in the context of food cues, stress and a control neutral relaxing cue exposure in healthy individuals.
METHODS
Twenty individuals (12 M; 8F; ages 18-45) with body mass index (BMI) in the lean (LN: N = 8; 3/8 female BMI: 18-24.9) or overweight/obese (OW: N = 12; 5/12 female; BMI: 25-37) range were enrolled in a controlled, hospital-based, 3-day laboratory experiment. On each day, subjects were exposed to a brief 5-min individualized guided imagery of stress, food cue or an active neutral-relaxing control cue script, followed by a food snack test (FST), with one imagery condition per day and order of imagery exposure randomized and counterbalanced across subjects. Subjective HP food craving and caloric intake, anxiety, cortisol and total ghrelin was assessed repeatedly during each test day.
RESULTS
Significant condition and condition × group effects for food craving, anxiety and HP calorie intake were observed, with food cue relative to neutral condition increasing HP food craving and intake across all subjects (p < .001), but stress relative to neutral condition increased HP food craving and intake in the OW but not LN group (p < .01). Pre-snack increases in food craving after exposure to food cues and to stress predicted greater subsequent HP food intake (p's < 0.01). Furthermore, ghrelin increased in the food cue and stress conditions (p < .01), but stress-induced increases in ghrelin was associated with HP food intake only in the OW/OB condition (p < .01). Finally, cortisol increased during food cue exposure and increased cortisol responses were associated with greater HP food caving and with intake (p's < 0.05).
CONCLUSIONS
These findings, while preliminary, validate a laboratory model of HP food motivation and intake and identify specific subjective and neuroendocrine responses that may play a role in HP snacking with implications for weight gain and obesity risk. (342 words).",2019,"Furthermore, ghrelin increased in the food cue and stress conditions (p < .01), but stress-induced increases in ghrelin was associated with HP food intake only in the OW/OB condition (p < .01).","['Twenty individuals (12\u202fM; 8F; ages 18-45) with body mass index (BMI) in the lean (LN: N\u202f=\u202f8; 3/8 female BMI: 18-24.9) or overweight/obese (OW: N\u202f=\u202f12; 5/12 female; BMI: 25-37) range were enrolled in a controlled, hospital-based, 3-day laboratory experiment', 'healthy individuals']","['brief 5-min individualized guided imagery of stress, food cue or an active neutral-relaxing control cue script, followed by a food snack test (FST), with one imagery condition per day and order of imagery exposure randomized and counterbalanced across subjects']","['food craving', 'HP overeating', 'food cue and stress conditions', 'HP food craving and intake', 'Food craving, cortisol and ghrelin responses', 'cortisol increased during food cue exposure and increased cortisol responses', 'subsequent HP food intake', 'food craving, anxiety and HP calorie intake', 'Subjective HP food craving and caloric intake, anxiety, cortisol and total ghrelin']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.027216,"Furthermore, ghrelin increased in the food cue and stress conditions (p < .01), but stress-induced increases in ghrelin was associated with HP food intake only in the OW/OB condition (p < .01).","[{'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Yale University School of Medicine, Department of Psychiatry, New Haven, CT 06159, United States of America. Electronic address: Rajita.Sinha@yale.edu.'}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Gu', 'Affiliation': 'Yale University, Yale Center for Analytic Sciences, New Haven, CT 06159, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Yale University School of Medicine, Department of Psychiatry, New Haven, CT 06159, United States of America.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Guarnaccia', 'Affiliation': 'Yale University School of Medicine, Department of Neurology, New Haven, CT 06519, United States of America.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112563']
635,32209645,Continuous Glucose Monitoring in Pregnancy: Importance of Analyzing Temporal Profiles to Understand Clinical Outcomes.,"OBJECTIVE
To determine if temporal glucose profiles differed between 1 ) women who were randomized to real-time continuous glucose monitoring (RT-CGM) or self-monitored blood glucose (SMBG), 2 ) women who used insulin pumps or multiple daily insulin injections (MDIs), and 3 ) women whose infants were born large for gestational age (LGA) or not, by assessing CGM data obtained from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT).
RESEARCH DESIGN AND METHODS
Standard summary metrics and functional data analysis (FDA) were applied to CGM data from the CONCEPTT trial (RT-CGM, n = 100; SMBG, n = 100) taken at baseline and at 24- and 34-weeks' gestation. Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.
RESULTS
FDA revealed that women using RT-CGM had significantly lower glucose (0.4-0.8 mmol/L [7-14 mg/dL]) for 7 h/day (0800 h to 1200 h and 1600 h to 1900 h) compared with those with SMBG. Women using pumps had significantly higher glucose (0.4-0.9 mmol/L [7-16 mg/dL]) for 12 h/day (0300 h to 0600 h, 1300 h to 1800 h, and 2030 h to 0030 h) at 24 weeks with no difference at 34 weeks compared with MDI. Women who had an LGA infant ran a significantly higher glucose by 0.4-0.7 mmol/L (7-13 mg/dL) for 4.5 h/day at baseline, by 0.4-0.9 mmol/L (7-16 mg/dL) for 16 h/day at 24 weeks, and by 0.4-0.7 mmol/L (7-13 mg/dL) for 14 h/day at 34 weeks.
CONCLUSIONS
FDA of temporal glucose profiles gives important information about differences in glucose control and its timing, which are undetectable by standard summary metrics. Women using RT-CGM were able to achieve better daytime glucose control, reducing fetal exposure to maternal glucose.",2020,"Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.
","['temporal glucose profiles differed between 1 ) women who were randomized to', 'Women who had an LGA infant ran a significantly', 'MDIs), and 3 ) women whose infants were born large for gestational age (LGA) or not, by assessing CGM data obtained from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT', 'Pregnancy']","['real-time continuous glucose monitoring (RT-CGM) or self-monitored blood glucose (SMBG), 2 ) women who used insulin pumps or multiple daily insulin injections']","['higher glucose', 'daytime glucose control, reducing fetal exposure to maternal glucose', '24-h glucose profiles']","[{'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",2.0,0.024243,"Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.
","[{'ForeName': 'Eleanor M', 'Initials': 'EM', 'LastName': 'Scott', 'Affiliation': 'Department of Clinical and Population Science, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, U.K. e.m.scott@leeds.ac.uk.'}, {'ForeName': 'Denice S', 'Initials': 'DS', 'LastName': 'Feig', 'Affiliation': 'Department of Medicine, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': ""Division of Maternal Health, St Thomas' Hospital, King's College London, London, U.K.""}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Law', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2527']
636,32023373,Lower versus Traditional Treatment Threshold for Neonatal Hypoglycemia.,"BACKGROUND
Worldwide, many newborns who are preterm, small or large for gestational age, or born to mothers with diabetes are screened for hypoglycemia, with a goal of preventing brain injury. However, there is no consensus on a treatment threshold that is safe but also avoids overtreatment.
METHODS
In a multicenter, randomized, noninferiority trial involving 689 otherwise healthy newborns born at 35 weeks of gestation or later and identified as being at risk for hypoglycemia, we compared two threshold values for treatment of asymptomatic moderate hypoglycemia. We sought to determine whether a management strategy that used a lower threshold (treatment administered at a glucose concentration of <36 mg per deciliter [2.0 mmol per liter]) would be noninferior to a traditional threshold (treatment at a glucose concentration of <47 mg per deciliter [2.6 mmol per liter]) with respect to psychomotor development at 18 months, assessed with the Bayley Scales of Infant and Toddler Development, third edition, Dutch version (Bayley-III-NL; scores range from 50 to 150 [mean {±SD}, 100±15]), with higher scores indicating more advanced development and 7.5 points (one half the SD) representing a clinically important difference). The lower threshold would be considered noninferior if scores were less than 7.5 points lower than scores in the traditional-threshold group.
RESULTS
Bayley-III-NL scores were assessed in 287 of the 348 children (82.5%) in the lower-threshold group and in 295 of the 341 children (86.5%) in the traditional-threshold group. Cognitive and motor outcome scores were similar in the two groups (mean scores [±SE], 102.9±0.7 [cognitive] and 104.6±0.7 [motor] in the lower-threshold group and 102.2±0.7 [cognitive] and 104.9±0.7 [motor] in the traditional-threshold group). The prespecified inferiority limit was not crossed. The mean glucose concentration was 57±0.4 mg per deciliter (3.2±0.02 mmol per liter) in the lower-threshold group and 61±0.5 mg per deciliter (3.4±0.03 mmol per liter) in the traditional-threshold group. Fewer and less severe hypoglycemic episodes occurred in the traditional-threshold group, but that group had more invasive diagnostic and treatment interventions. Serious adverse events in the lower-threshold group included convulsions (during normoglycemia) in one newborn and one death.
CONCLUSIONS
In otherwise healthy newborns with asymptomatic moderate hypoglycemia, a lower glucose treatment threshold (36 mg per deciliter) was noninferior to a traditional threshold (47 mg per deciliter) with regard to psychomotor development at 18 months. (Funded by the Netherlands Organization for Health Research and Development; HypoEXIT Current Controlled Trials number, ISRCTN79705768.).",2020,"RESULTS
Bayley-III-NL scores were assessed in 287 of the 348 children (82.5%) in the lower-threshold group and in 295 of the 341 children (86.5%) in the traditional-threshold group.","['689 otherwise healthy newborns born at 35 weeks of gestation or later and identified as being at risk for hypoglycemia, we compared two threshold values for treatment of asymptomatic moderate hypoglycemia', 'otherwise healthy newborns with asymptomatic moderate hypoglycemia', 'newborns who are preterm, small or large for gestational age, or born to mothers with diabetes']",[],"['mean glucose concentration', 'severe hypoglycemic episodes', 'Serious adverse events', 'Cognitive and motor outcome scores', 'Bayley-III-NL scores', 'Neonatal Hypoglycemia']","[{'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth (finding)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205448', 'cui_str': 'Two'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia (disorder)'}]",689.0,0.0369896,"RESULTS
Bayley-III-NL scores were assessed in 287 of the 348 children (82.5%) in the lower-threshold group and in 295 of the 341 children (86.5%) in the traditional-threshold group.","[{'ForeName': 'Anne A M W', 'Initials': 'AAMW', 'LastName': 'van Kempen', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'P Frank', 'Initials': 'PF', 'LastName': 'Eskes', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Debbie H G M', 'Initials': 'DHGM', 'LastName': 'Nuytemans', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Johanna H', 'Initials': 'JH', 'LastName': 'van der Lee', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Lea M', 'Initials': 'LM', 'LastName': 'Dijksman', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'van Veenendaal', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Flip J P C M', 'Initials': 'FJPCM', 'LastName': 'van der Hulst', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Rob M J', 'Initials': 'RMJ', 'LastName': 'Moonen', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Luc J I', 'Initials': 'LJI', 'LastName': 'Zimmermann', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Ellen P', 'Initials': 'EP', 'LastName': ""van 't Verlaat"", 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Minouche', 'Initials': 'M', 'LastName': 'van Dongen-van Baal', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Ben A', 'Initials': 'BA', 'LastName': 'Semmekrot', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Hélène G', 'Initials': 'HG', 'LastName': 'Stas', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Ron H T', 'Initials': 'RHT', 'LastName': 'van Beek', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'José J', 'Initials': 'JJ', 'LastName': 'Vlietman', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Dijk', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Jacqueline U M', 'Initials': 'JUM', 'LastName': 'Termote', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Rogier C J', 'Initials': 'RCJ', 'LastName': 'de Jonge', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Amerik C', 'Initials': 'AC', 'LastName': 'de Mol', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Marianne W A', 'Initials': 'MWA', 'LastName': 'Huysman', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Joke H', 'Initials': 'JH', 'LastName': 'Kok', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Offringa', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Boluyt', 'Affiliation': ""From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1905593']
637,32272214,Hematoporphyrin monomethyl ether mediated sonodynamic antimicrobial chemotherapy on porphyromonas gingivalis in vitro.,"This study aimed to evaluate the efficacy of hematoporphyrin monomethyl ether (HMME)-mediated sonodynamic antimicrobial chemotherapy (SACT) on Porphyromonas gingivalis (P. gingivalis). P. gingivalis (ATCC 33277) was used in the present study. The bacterial suspension was randomly divided into five groups: Group 1 was incubated for 2 h in the dark with HMME in various concentrations (10, 20, 30 and 40 μg/mL). Then exposed to 1 MHz ultrasound frequency with 3 W/cm 2 ultrasound intensity for 10 min. Group 2 was incubated with 40 μg/mL HMME and then irradiated with 2, 4, 6, 8 and 10 min ultrasonic time. Group 3 received different HMME concentration (10, 20, 30 and 40 μg/mL) treatment alone with no ultrasound as the HMME control group. Group 4 received ultrasound treatment alone in different ultrasonic time (2, 4, 6, 8 and 10 min) with no HMME as the ultrasound control group. Group 5 received no treatment as the no treatment control group. After the SACT, the bactericidal effect was determined by the colony forming unit assay. The intracellular content of reactive oxygen species (ROS) was detected using the laser scanning confocal microscope based on DCFH-DA. 4.7 lg reduction in CFU, When P. gingivalis was treated with ultrasound (3 W/cm 2 for 10 min) at 40 μg/mL HMME concentration (P < 0.01). The intracellular ROS in SDT group had a significant difference in comparison with the no treatment control group (P < 0.01). HMME mediated SACT can be a potential antibacterial therapy to significantly inhibit P. gingivalis growth.",2020,The intracellular ROS in SDT group had a significant difference in comparison with the no treatment control group (P<0.01).,[],"['HMME mediated SACT', 'ultrasound treatment alone', 'hematoporphyrin monomethyl ether (HMME)-mediated sonodynamic antimicrobial chemotherapy (SACT', 'Hematoporphyrin monomethyl ether mediated sonodynamic antimicrobial chemotherapy', 'HMME concentration (10, 20, 30 and 40 μg/mL) treatment alone with no ultrasound as the HMME control group']","['intracellular content of reactive oxygen species (ROS', 'bactericidal effect', 'intracellular ROS']",[],"[{'cui': 'C1530433', 'cui_str': 'hematoporphyrin monomethyl ether'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0198217,The intracellular ROS in SDT group had a significant difference in comparison with the no treatment control group (P<0.01).,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Stomatology, The Fourth Affiliated Hospital, Harbin Medical University, Harbin, 150001, China. Electronic address: zoeyzhang0415@163.com.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Stomatology, The Fourth Affiliated Hospital, Harbin Medical University, Harbin, 150001, China; Department of Restorative Dentistry, Faculty of Dental Medicine and Graduate School of Dental Medicine, Hokkaido University, Sapporo, 0600808, Japan. Electronic address: zhanghongbo606@163.com.'}, {'ForeName': 'Deshu', 'Initials': 'D', 'LastName': 'Zhuang', 'Affiliation': 'Department of Stomatology, The Fourth Affiliated Hospital, Harbin Medical University, Harbin, 150001, China; Faculty of Dentistry, Department of Oral Biological and Medical Sciences, University of British Columbia, Vancouver, BC V6T 1Z3, Canada. Electronic address: stevenchuang88@126.com.'}, {'ForeName': 'Liangjia', 'Initials': 'L', 'LastName': 'Bi', 'Affiliation': 'Department of Stomatology, The Fourth Affiliated Hospital, Harbin Medical University, Harbin, 150001, China. Electronic address: biliangjia6601@126.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Condensed Matter Science and Technology Institute, Harbin Institute of Technology, Harbin, 150080, China. Electronic address: huzheng0010@163.com.'}, {'ForeName': 'Wenwu', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Condensed Matter Science and Technology Institute, Harbin Institute of Technology, Harbin, 150080, China; Department of Mathematics and Materials Research Institute, The Pennsylvania State University, University Park, PA, 16802, USA. Electronic address: caowenwu808@163.com.'}]",Microbial pathogenesis,['10.1016/j.micpath.2020.104192']
638,32403158,"Stenting the ureteroneocystostomy reduces urological complications in kidney transplantation: a noninferiority randomized controlled trial, SPLINT trial.","The role of ureteral stents in living-donor kidney transplantation remains uncertain. In this randomized controlled trial (SPLINT), we compared urological complications in living-donor kidney transplantations performed with or without stents. We included 200 consecutive patients that received living-donor kidney transplantations at the Erasmus MC, University Medical Center, Rotterdam. Patients (124 males, 76 females, mean age 54 ± 13) were randomized for suprapubic externalized single J stents (N = 100) or no stent (N = 100). The primary outcome was the probability of a percutaneous nephrostomy insertion (PCN) during a 12-month follow-up. To assess whether no stenting is noninferior to stenting, we allowed the probability of a PCN to increase by at most 5% (this is the noninferiority margin). Baseline characteristics were comparable between groups. In the no-stent group, there were more PCN insertions, 14% (95% CI 4.3-23.7%); urinary leakages, 12% (95% CI 5.4-21.3%); and surgical re-interventions because of urological complications, 8% (95% CI 1.5-14.5%). The stent group had more hematuria, 26% (95% CI 13.1-38.9%); and graft rejections, 15% (95% CI 2.7-27.3%). Patients in both groups had similar mean GFRs at several time points. Besides a better Euro-Qol-5D in the no-stent group at 2 and 6 weeks postoperative, similar quality of life was reported based on SF-36 and Euro-Qol-5D scores. In this trial, noninferiority has not been demonstrated for no-stent placement in relation to the number urological complications.",2020,The stent group had more hematuria 26% (95%CI 13.1- 38.9%) and graft rejections 15% (95%CI 2.7- 27.3%).,"['kidney transplantation', '200 consecutive patients that received living donor kidney transplantations at the Erasmus MC, University Medical Center Rotterdam', 'Patients (124 males, 76 females, mean age 54 ± 13']","['ureteral stents', 'suprapubic externalized single J stents (N=100) or no stent', 'ureteroneocystostomy', 'living donor kidney transplantations performed with or without stents']","['quality of life', 'urological complications', 'hematuria', 'probability of a percutaneous nephrostomy insertion (PCN', 'graft rejections', 'urinary leakages']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0205498', 'cui_str': 'Suprapubic approach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0194307', 'cui_str': 'Intravesical reimplantation of ureter'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0027724', 'cui_str': 'Percutaneous insertion of nephrostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",200.0,0.322335,The stent group had more hematuria 26% (95%CI 13.1- 38.9%) and graft rejections 15% (95%CI 2.7- 27.3%).,"[{'ForeName': 'Liselotte S S', 'Initials': 'LSS', 'LastName': 'Ooms', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Minnee', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank J M F', 'Initials': 'FJMF', 'LastName': 'Dor', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Diederik J A N', 'Initials': 'DJAN', 'LastName': 'Kimenai', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Khe C K', 'Initials': 'KCK', 'LastName': 'Tran', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Hermien', 'Initials': 'H', 'LastName': 'Hartog', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'van de Wetering', 'Affiliation': 'Department of Nephrology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Sten P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan N M', 'Initials': 'JNM', 'LastName': 'IJzermans', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Turkan', 'Initials': 'T', 'LastName': 'Terkivatan', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13638']
639,32406100,Comparison between minimal fluoroscopy and conventional approaches for visually guided laser balloon pulmonary vein isolation ablation.,"INTRODUCTION
Although balloon-based techniques, such as the laser balloon (LB) ablation have simplified pulmonary vein isolation (PVI), procedural fluoroscopy usage remains higher in comparison to radiofrequency PVI approaches due to limited 3-dimensional mapping system integration.
METHODS
In this prospective study, 50 consecutive patients were randomly assigned in alternating fashion to a low fluoroscopy group (LFG; n = 25) or conventional fluoroscopy group (CFG; n = 25) and underwent de novo PVI procedures using visually guided LB technique.
RESULTS
There was no statistical difference in baseline characteristics or cross-overs between treatment groups. Acute PVI was accomplished in all patients. Mean follow up was 318 ± 69 days. Clinical recurrence of atrial fibrillation after PVI was similar between groups (CFG: 19% vs LFG: 15%; P = .72). Total fluoroscopy time was significantly lower in the LFG than the CFG (1.7 ± 1.4 vs 16.9 ± 5.9 minutes; P < .001) despite similar total procedure duration (143 ± 22 vs 148 ± 22 minutes; P = .42) and mean LA dwell time (63 ± 15 vs 59 ± 10 minutes; P = .28). Mean dose area product was significantly lower in the LFG (181 ± 125 vs 1980 ± 750 μGym 2 ; P < .001). Fluoroscopy usage after transseptal access was substantially lower in the LFG (0.63 ± 0.43 vs 11.70 ± 4.32 minutes; P < .001). Complications rates were similar between both groups (4% vs 2%; P = .57).
CONCLUSIONS
This study demonstrates that LB PVI can be safely achieved using a novel low fluoroscopy protocol while also substantially reducing fluoroscopy usage and radiation exposure in comparison to conventional approaches for LB ablation.",2020,Clinical recurrence of AF after PVI was similar between groups (CFG: 19% vs LFG: 15%; p=0.72).,['50 consecutive patients'],"['Minimal Fluoroscopy and Conventional Approaches for Visually Guided Laser Balloon Pulmonary Vein Isolation Ablation', 'LB PVI', 'LFG', 'laser balloon (LB) ablation', 'low fluoroscopy group (LFG, n=25) or conventional fluoroscopy group (CFG, n=25) and underwent de novo PVI procedures using visually guided LB technique']","['Acute PVI', 'Mean DAP', 'Fluoroscopy usage after transseptal access', 'Clinical recurrence of AF after PVI', 'mean LA dwell time', 'Total fluoroscopy time', 'Complications rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.0493569,Clinical recurrence of AF after PVI was similar between groups (CFG: 19% vs LFG: 15%; p=0.72).,"[{'ForeName': 'Henry D', 'Initials': 'HD', 'LastName': 'Huang', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Serafini', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Macias', 'Affiliation': 'Division of Cardiology, UCLA Cardiac Arrhythmia Center, Ronald Reagan UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Winterfield', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Parikshit S', 'Initials': 'PS', 'LastName': 'Sharma', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Larsen', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Kousik', 'Initials': 'K', 'LastName': 'Krishnan', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Trohman', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14546']
640,31482404,"Acute effect of orange chromatic environment on perceived health status, pain, and vital signs during chemotherapy treatment.","PURPOSE
The study is aimed at assessing the acute effect of orange color and natural light exposure on cancer patients during chemotherapy sessions. Warmer environments and rooms receiving more sunlight hours were expected to impact vital signs, quality of life, and pain symptoms.
METHODS
We used a single-group repeated-measures clinical trial design. For the purpose of the study, chemotherapy rooms were modified based on two experimental factors: color (white vs. orange) and sunlight orientation (south vs. north). On four consecutive sessions, cancer patients were randomly assigned to one of the following conditions: orange-north, orange-south, white-north, and white-south. They received chemotherapy per standard of care. The following outcomes were assessed: blood pressure, body temperature, heart rate, and European Quality of Life Five-Dimension Five-Level Scale Questionnaire (EUROQOL-5D-5L) including the visual analogue scale (EQ-VAS).
RESULTS
Statistically significant beneficial effect of orange color room in self-rated health was found (p = 0.036, d = 0.28). Small differences in other parameters (body temperature, d = 0.34; diastolic blood pressure, d = 0.37; systolic blood pressure, d = 0.28) did not reach statistical significance. No differences were found based on room orientation.
CONCLUSIONS
Compared with a cool-color design, a warm-color living environment could have a positive effect on patients' well-being during chemotherapy sessions. Although the clinical effect size on perceived health status and vital signs could be considered small, the cost-effectiveness analysis would support the use of the proposed configurations. More research is still needed.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03873519.",2020,"Statistically significant beneficial effect of orange color room in self-rated health was found (p = 0.036, d = 0.28).",['cancer patients during chemotherapy sessions'],"['chemotherapy', 'orange chromatic environment', 'orange color and natural light exposure']","['self-rated health', 'diastolic blood pressure', 'impact vital signs, quality of life, and pain symptoms', 'systolic blood pressure', 'blood pressure, body temperature, heart rate, and European Quality of Life Five-Dimension Five-Level Scale Questionnaire (EUROQOL-5D-5L) including the visual analogue scale (EQ-VAS', 'perceived health status, pain, and vital signs']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1313858', 'cui_str': 'Orange color (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",,0.058779,"Statistically significant beneficial effect of orange color room in self-rated health was found (p = 0.036, d = 0.28).","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gómez-Vela', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain.'}, {'ForeName': 'María Fátima', 'Initials': 'MF', 'LastName': 'Hernández Martín', 'Affiliation': 'Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Román', 'Affiliation': 'IOB Institute of Oncology, Quironsalud Group, Juan Bravo 39, 28006, Madrid, Spain.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'Clinical Research Institute, Texas Tech University Health Sciences Center, 3106 4th Street, STOP 8183, Lubbock, TX, 79430, USA. eneko@cop.es.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05064-w']
641,31498030,Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma.,"PURPOSE
Outcome measures that comprehensively capture attributes of immuno-oncology agents, including prolonged treatment-free time and persistent treatment-related adverse events (TRAEs), are needed to complement conventional survival end points.
METHODS
We pooled data from the CheckMate 067 and 069 clinical trials of nivolumab and ipilimumab, as monotherapies or in combination, for patients with advanced melanoma. Treatment-free survival (TFS) was defined as the area between Kaplan-Meier curves for two conventional time-to-event end points, each defined from random assignment: time to immune checkpoint inhibitor (ICI) protocol therapy cessation and time to subsequent systemic therapy initiation or death. TFS was partitioned as time with and without toxicity by a third end point, time to cessation of both ICI therapy and toxicity. Toxicity included persistent and late-onset grade 3 or higher TRAEs. The area under each Kaplan-Meier curve was estimated by the 36-month restricted mean time.
RESULTS
At 36 months, many of the 1,077 patients who initiated ICI therapy were surviving free of subsequent therapy initiation (47% nivolumab plus ipilimumab, 37% nivolumab, 15% ipilimumab). The restricted mean TFS was longer for nivolumab plus ipilimumab (11.1 months) compared with nivolumab (4.6 months; difference, 6.5 months; 95% CI, 5.0 to 8.0 months) or ipilimumab (8.7 months; difference, 2.4 months; 95% CI, 0.8 to 4.1 months); restricted mean TFS represented 31% (3% with and 28% without toxicity), 13% (1% and 11%), and 24% (less than 1% and 23%) of the 36-month period, respectively, in the three treatment groups. TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
CONCLUSION
The analysis of TFS between ICI cessation and subsequent therapy initiation revealed longer TFS without toxicity for patients with advanced melanoma who received nivolumab plus ipilimumab compared with nivolumab or ipilimumab. Regardless of treatment, a small proportion of the TFS involved grade 3 or higher TRAEs.",2019,"TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
","['Patients With Advanced Melanoma', 'patients with advanced melanoma']","['nivolumab plus ipilimumab', 'Immune Checkpoint Inhibition', 'ipilimumab', 'nivolumab or ipilimumab', 'nivolumab and ipilimumab', 'TFS']","['Treatment-free survival (TFS', 'TFS without toxicity', 'surviving free of subsequent therapy initiation', 'mean TFS', 'Treatment-Free Survival', 'Toxicity included persistent and late-onset grade 3 or higher TRAEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",1077.0,0.196501,"TFS without toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ipilimumab (difference, 1.7 months).
","[{'ForeName': 'Meredith M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Werner', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sumati', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gupte-Singh', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'University of Pittsburgh Cancer Institute, Pittsburgh, PA.'}, {'ForeName': 'Harriet M', 'Initials': 'HM', 'LastName': 'Kluger', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Postow', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Ritchings', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Tarhini', 'Affiliation': 'Emory University and Winship Comprehensive Cancer Center, Atlanta, GA.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Harvard Medical School, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00345']
642,31668476,"Randomized, Sham-Controlled Trial of Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Tics in Adolescents With Tourette Syndrome.","BACKGROUND
Activity in the supplementary motor area (SMA) has been associated with tics in Tourette syndrome (TS). The aim of this study was to test a novel intervention-real-time functional magnetic resonance imaging neurofeedback from the SMA-for reduction of tics in adolescents with TS.
METHODS
Twenty-one adolescents with TS were enrolled in a double-blind, randomized, sham-controlled, crossover study involving two sessions of neurofeedback from their SMA. The primary outcome measure of tic severity was the Yale Global Tic Severity Scale administered by an independent evaluator before and after each arm. The secondary outcome was control over the SMA assessed in neuroimaging scans, in which subjects were cued to increase/decrease activity in SMA without receiving feedback.
RESULTS
All 21 subjects completed both arms of the study and all assessments. Participants had significantly greater reduction of tics on the Yale Global Tic Severity Scale after real neurofeedback as compared with the sham control (p < .05). Mean Yale Global Tic Severity Scale Total Tic score decreased from 25.2 ± 4.6 at baseline to 19.9 ± 5.7 at end point in the neurofeedback condition and from 24.8 ± 8.1 to 23.3 ± 8.5 in the sham control condition. The 3.8-point difference is clinically meaningful and corresponds to an effect size of 0.59. However, there were no differences in changes on the secondary measure of control over the SMA.
CONCLUSIONS
This first randomized controlled trial of real-time functional magnetic resonance imaging neurofeedback in adolescents with TS suggests that this neurofeedback intervention may be helpful for improving tic symptoms. However, no effects were found in terms of change in control over the SMA, the hypothesized mechanism of action.",2020,Participants had significantly greater reduction of tics on the Yale Global Tic Severity Scale after real neurofeedback as compared with the sham control (p < .05).,"['Adolescents With Tourette Syndrome', 'Twenty-one adolescents with TS', 'adolescents with TS']",['Real-Time Functional Magnetic Resonance Imaging Neurofeedback'],"['Yale Global Tic Severity Scale administered by an independent evaluator', 'reduction of tics on the Yale Global Tic Severity Scale', 'tic severity', 'control over the SMA assessed in neuroimaging scans', 'Mean Yale Global Tic Severity Scale Total Tic score']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040517', 'cui_str': 'Chronic Motor and Vocal Tic Disorder'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]","[{'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0441633'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",21.0,0.452751,Participants had significantly greater reduction of tics on the Yale Global Tic Severity Scale after real neurofeedback as compared with the sham control (p < .05).,"[{'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Sukhodolsky', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Walsh', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Koller', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Eilbott', 'Affiliation': 'SurveyBott LLC, Brooklyn, New York.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Rance', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Fulbright', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bloch', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Leckman', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Scheinost', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut; Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut; Department of Statistics and Data Science, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hampson', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut; Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut; Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut. Electronic address: michelle.hampson@yale.edu.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.07.035']
643,30939090,Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303.,"PURPOSE
Alliance/CALGB 50303 (NCT00118209), an intergroup, phase III study, compared dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as frontline therapy for diffuse large B-cell lymphoma.
PATIENTS AND METHODS
Patients received six cycles of DA-EPOCH-R or R-CHOP. The primary objective was progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety.
RESULTS
Between 2005 and 2013, 524 patients were registered; 491 eligible patients were included in the final analysis. Most patients (74%) had stage III or IV disease; International Prognostic Index (IPI) risk groups included 26% IPI 0 to 1, 37% IPI 2, 25% IPI 3, and 12% IPI 4 to 5. At a median follow-up of 5 years, PFS was not statistically different between the arms (hazard ratio, 0.93; 95% CI, 0.68 to 1.27; P = .65), with a 2-year PFS rate of 78.9% (95% CI, 73.8% to 84.2%) for DA-EPOCH-R and 75.5% (95% CI, 70.2% to 81.1%) for R-CHOP. OS was not different (hazard ratio, 1.09; 95% CI, 0.75 to 1.59; P = .64), with a 2-year OS rate of 86.5% (95% CI, 82.3% to 91%) for DA-EPOCH-R and 85.7% (95% CI, 81.4% to 90.2%) for R-CHOP. Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively). Five treatment-related deaths (2.1%) occurred in each arm.
CONCLUSION
In the 50303 study population, the more intensive, infusional DA-EPOCH-R was more toxic and did not improve PFS or OS compared with R-CHOP. The more favorable results with R-CHOP compared with historical controls suggest a potential patient selection bias and may preclude generalizability of results to specific risk subgroups.",2019,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","['524 patients were registered; 491 eligible patients were included in the final analysis', 'Between 2005 and 2013', 'diffuse large B-cell lymphoma', 'Patients received six cycles of', 'Diffuse Large B-Cell Lymphoma']","['Dose-Adjusted EPOCH-R Compared With R-CHOP', 'etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'DA-EPOCH-R or R-CHOP']","['febrile neutropenia', 'PFS or OS', 'mucositis', 'stage III or IV disease; International Prognostic Index', 'progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety', 'Grade 3 and 4 adverse events', 'infection', '2-year PFS rate', 'neuropathy', '2-year OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C4520227', 'cui_str': 'Dose-adjusted EPOCH'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",524.0,0.170783,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","[{'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': '4 Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Levi D', 'Initials': 'LD', 'LastName': 'Pederson', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '6 MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': '7 University of Rochester, Rochester, NY.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Staudt', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nina D', 'Initials': 'ND', 'LastName': 'Wagner-Johnston', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': '8 The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Abramson', 'Affiliation': '9 Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Nishitha M', 'Initials': 'NM', 'LastName': 'Reddy', 'Affiliation': '10 Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': '11 Northwestern University, Chicago, IL.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': '12 University of Wisconsin, Madison, WI.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': '13 Univeristy of Washington, Seattle, WA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mathew', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': '15 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Richards', 'Affiliation': '16 University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01994']
644,30941799,A descriptive analysis of gut microbiota composition in differentially reared infant rhesus monkeys (Macaca mulatta) across the first 6 months of life.,"The gastrointestinal microbiome is recognized as a critical component in host immune function, physiology, and behavior. Early life experiences that alter diet and social contact also influence these outcomes. Despite the growing number of studies in this area, no studies to date have examined the contribution of early life experiences on the gut microbiome in infants across development. Such studies are important for understanding the biological and environmental factors that contribute to optimal gut microbial colonization and subsequent health. We studied infant rhesus monkeys (Macaca mulatta) across the first 6 months of life that were pseudo-randomly assigned to one of two different rearing conditions at birth: mother-peer-reared (MPR), in which infants were reared in social groups with many other adults and peers and nursed on their mothers, or nursery-reared (NR), in which infants were reared by human caregivers, fed formula, and given daily social contact with peers. We analyzed the microbiome from rectal swabs (total N = 97; MPR = 43, NR = 54) taken on the day of birth and at postnatal Days 14, 30, 90, and 180 using 16S rRNA gene sequencing. Bacterial composition differences were evident as early as 14 days, with MPR infants exhibiting a lower abundance of Bifidobacterium and a higher abundance of Bacteroides than NR infants. The most marked differences were observed at 90 days, when Bifidobacterium, Lactobacillus, Streptococcus, Bacteroides, Clostridium, and Prevotella differed across rearing groups. By Day 180, no differences in the relative abundances of the bacteria of interest were observed. These novel findings in developing primate neonates indicate that the early social environment as well as diet influence gut microbiota composition very early in life. These results also lay the groundwork for mechanistic studies examining the effects of early experiences on gut microbiota across development with the ultimate goal of understanding the clinical significance of developmental changes.",2019,"The most marked differences were observed at 90 days, when Bifidobacterium, Lactobacillus, Streptococcus, Bacteroides, Clostridium, and Prevotella differed across rearing groups.","['infant rhesus monkeys (Macaca mulatta) across the first 6 months of life that were pseudo-randomly assigned to one of two different rearing conditions at birth: mother-peer-reared (MPR), in which infants were reared in social groups with many other adults and peers and nursed on their mothers, or nursery-reared (NR), in which infants were reared by human caregivers, fed formula, and given daily social contact with peers', 'differentially reared infant rhesus monkeys (Macaca mulatta']",[],"['Bifidobacterium, Lactobacillus, Streptococcus, Bacteroides, Clostridium, and Prevotella', 'Bacterial composition differences', 'relative abundances of the bacteria of interest']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0024400', 'cui_str': 'Rhesus Macaque'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0687744', 'cui_str': 'Social group (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0026447', 'cui_str': 'Monkeys'}]",[],"[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0004661', 'cui_str': 'Bacteroides'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}]",,0.0182344,"The most marked differences were observed at 90 days, when Bifidobacterium, Lactobacillus, Streptococcus, Bacteroides, Clostridium, and Prevotella differed across rearing groups.","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Dettmer', 'Affiliation': 'Laboratory of Comparative Ethology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Poolesville, Maryland.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Allen', 'Affiliation': ""Center for Microbial Pathogenesis, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Jaggers', 'Affiliation': ""Center for Microbial Pathogenesis, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Bailey', 'Affiliation': ""Center for Microbial Pathogenesis, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}]",American journal of primatology,['10.1002/ajp.22969']
645,31112475,Positron Emission Tomography Score Has Greater Prognostic Significance Than Pretreatment Risk Stratification in Early-Stage Hodgkin Lymphoma in the UK RAPID Study.,"PURPOSE
Accurate stratification of patients is an important goal in Hodgkin lymphoma (HL), but the role of pretreatment clinical risk stratification in the context of positron emission tomography (PET) -adapted treatment is unclear. We performed a subsidiary analysis of the RAPID trial to assess the prognostic value of pretreatment risk factors and PET score in determining outcomes.
PATIENTS AND METHODS
Patients with stage IA to IIA HL and no mediastinal bulk underwent PET assessment after three cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine; 143 PET-positive patients (PET score, 3 to 5) received a fourth doxorubicin, bleomycin, vinblastine, and dacarbazine cycle and involved-field radiotherapy, and 419 patients in complete metabolic remission were randomly assigned to receive involved-field radiotherapy (n = 208) or no additional treatment (n = 211). Cox regression was used to investigate the association between PET score and pretreatment risk factors with HL-specific event-free survival (EFS).
RESULTS
High PET score was associated with inferior EFS, before ( P < .001) and after adjustment ( P = .01) for baseline risk stratification. Only patients with a postchemotherapy PET score of 5 (uptake ≥ three times maximum liver uptake) had an increased risk of progression or HL-related death (hazard ratio, 9.4 v score of 3; 95% CI, 2.8 to 31.3 and hazard ratio, 6.7 v score of 4; 95% CI, 1.4 to 31.7). Patients with a PET score of 5 also had inferior progression-free and overall survival. There was no association between European Organisation for Research and Treatment of Cancer or German Hodgkin Study Group risk group and EFS, before or after adjusting for PET score (all P > .4).
CONCLUSION
In RAPID, a positive PET scan did not carry uniform prognostic weight; only a PET score of 5 was associated with inferior outcomes. This suggests that in future trials involving patients without B symptoms or mediastinal bulk, a score of 5 rather than a positive PET result should be used to guide treatment escalation in early-stage HL.",2019,"There was no association between European Organisation for Research and Treatment of Cancer or German Hodgkin Study Group risk group and EFS, before or after adjusting for PET score (all P > .4).
","['Patients with stage IA to IIA HL and no mediastinal bulk underwent PET assessment after three cycles of', '143 PET-positive patients (PET score, 3 to 5) received a fourth', '419 patients in complete metabolic remission']","['doxorubicin, bleomycin, vinblastine, and dacarbazine', 'receive involved-field radiotherapy (n = 208) or no additional treatment', 'doxorubicin, bleomycin, vinblastine, and dacarbazine cycle and involved-field radiotherapy']","['postchemotherapy PET score of 5 (uptake ≥ three times maximum liver uptake', 'inferior progression-free and overall survival', 'Positron Emission Tomography Score', 'risk of progression or HL-related death (hazard ratio', 'PET score and pretreatment risk factors with HL-specific event-free survival (EFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457150', 'cui_str': 'Stage Ia'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",,0.216386,"There was no association between European Organisation for Research and Treatment of Cancer or German Hodgkin Study Group risk group and EFS, before or after adjusting for PET score (all P > .4).
","[{'ForeName': 'Sally F', 'Initials': 'SF', 'LastName': 'Barrington', 'Affiliation': ""1 King's College London and Guy's and St Thomas' PET Centre, Kings College London, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Phillips', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Counsell', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hancock', 'Affiliation': '3 University of Sheffield and Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pettengell', 'Affiliation': ""4 St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': '5 Cancer Research UK Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Townsend', 'Affiliation': '6 University College Hospital London, London, United Kingdom.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Culligan', 'Affiliation': '7 Aberdeen Royal Infirmary, Aberdeen, United Kingdom.'}, {'ForeName': 'Bilyana', 'Initials': 'B', 'LastName': 'Popova', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clifton-Hadley', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McMillan', 'Affiliation': '8 Nottingham City Hospitals National Health Service (NHS) Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoskin', 'Affiliation': '9 Mount Vernon Hospital, Middlesex, United Kingdom.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': ""O'Doherty"", 'Affiliation': ""1 King's College London and Guy's and St Thomas' PET Centre, Kings College London, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Illidge', 'Affiliation': '10 Institute of Cancer Sciences and the Christie NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Radford', 'Affiliation': '10 Institute of Cancer Sciences and the Christie NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01799']
646,32211798,Circulating Insulin-Like Growth Factor-1 Is Positively Associated with Growth and Cognition in 6- to 9-Year-Old Schoolchildren from Ghana.,"BACKGROUND
Milk intake stimulates linear growth and improves cognition in children from low-income countries. These effects may be mediated through insulin-like growth factor-1 (IGF-1).
OBJECTIVE
The objective was to assess the effect of milk supplement on circulating IGF-1 and to assess IGF-1 as a correlate of growth and cognition in children.
METHODS
Secondary data on blood spot IGF-1 from a randomized, double-blind, controlled trial in 6-9-y-old children from rural Ghana were analyzed. Intervention groups received porridge with non-energy-balanced supplements: 8.8 g milk protein/d, 100 kcal/d (Milk8); 4.4 g milk and 4.4 g rice protein/d, 100 kcal/d (Milk/rice); 4.4 g milk protein/d, 48 kcal/d (Milk4); or a control (no protein, 10 kcal/d). IGF-1, length, body composition, and Cambridge Neuropsychological Test Automated Battery (CANTAB) were measured at 3.5 or 8.5 mo. Linear regressions were used to assess the effect of milk interventions on IGF-1 and IGF-1 as a correlate of growth and cognition.
RESULTS
The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3) ng/mL higher in children receiving Milk8 compared with the control. The IGF-1 increases in the isonitrogenous, isoenergetic Milk/rice or the Milk4 groups were not different from the control (P ≥ 0.49). The increase in IGF-1 was associated with improvements in 4 out of 5 CANTAB domains. The strongest associations included reductions in ""mean correct latency"" from Pattern Recognition Memory and ""pre-extradimensional (pre-ED) shift errors"" from Intra/Extradimensional Set Shift (P ≤ 0.005). In addition, change in IGF-1 was positively associated with changes in height, weight, and fat-free mass (P ≤ 0.001).
CONCLUSIONS
Intake of skimmed milk powder corresponding to one, but not half a glass of milk on school days stimulates IGF-1 in 6-9-y-old Ghanian children. IGF-1 seems to mediate the effect of milk intake on growth and cognition. The association between IGF-1 and cognition in relation to milk intake is novel and opens possibilities for dietary interventions to improve cognition.",2020,"The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3)","['6-9-y-old children from rural Ghana were analyzed', 'children', 'children from low-income countries']","['porridge with non-energy-balanced supplements: 8.8\xa0g milk protein', 'milk supplement']","['change in IGF-1', 'IGF-1, length, body composition, and Cambridge Neuropsychological Test Automated Battery (CANTAB', 'IGF-1', 'IGF-1 increases', 'Circulating Insulin-Like Growth Factor-1', 'mean correct latency"" from Pattern Recognition Memory and ""pre-extradimensional (pre-ED) shift errors"" from Intra', 'Growth and Cognition', 'blood spot IGF-1', 'height, weight, and fat-free mass']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}]",,0.0402681,"The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3)","[{'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Grenov', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Larnkjær', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Serena', 'Affiliation': 'Global Nutrition, Arla Foods amba, Skejby, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mølgaard', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University, St Louis, MO, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa075']
647,32211803,"Spices in a High-Saturated-Fat, High-Carbohydrate Meal Reduce Postprandial Proinflammatory Cytokine Secretion in Men with Overweight or Obesity: A 3-Period, Crossover, Randomized Controlled Trial.","BACKGROUND
Postprandial inflammation that occurs concurrently with hyperglycemia and hyperlipidemia after ingestion of a high-saturated-fat, high-carbohydrate meal (HFCM) is a risk factor for cardiovascular disease (CVD). Numerous preclinical and clinical studies demonstrate anti-inflammatory effects of individual spices. However, the effect of consumption of a spice blend on inflammatory mediators has not been examined in a randomized controlled trial.
OBJECTIVES
The objective of this study was to investigate the postprandial effect of a blend of spices in a HFCM on inflammatory cytokine responses.
METHODS
Nonsmoking men (40-65 y old) with overweight/obesity (25 ≤ BMI ≤ 35 kg/m2), elevated waist circumference (≥ 94 cm), and ≥ 1 CVD risk factor were recruited for a 3-period crossover study ( n = 12). In random order, participants consumed the following: a HFCM (∼1000 kcal, 33% kcal from saturated fat and 36% kcal from carbohydrate), a HFCM containing 2 g spice blend, or an HFCM containing 6 g spice blend. The spice blend consisted of basil, bay leaf, black pepper, cinnamon, coriander, cumin, ginger, oregano, parsley, red pepper, rosemary, thyme, and turmeric. Blood was collected before, and hourly for 4 h after the HFCM. Peripheral blood mononuclear cells (PBMCs) were isolated, and the percentage of CD14 +/Human Leukocyte Antigen-DR isotype + (HLA-DR +) monocytes and proinflammatory cytokine concentrations in plasma and LPS-stimulated PBMCs were quantified as secondary outcomes.
RESULTS
There was a significant spice-by-time interaction on IL-1β (P < 0.001), IL-8 (P = 0.020), and TNF-α (P = 0.009) secretion from LPS-stimulated PBMCs. IL-1β secretion from LPS-stimulated PBMCs was significantly reduced (1314%) at 240 min after HFCM consumption containing 6 g, but not 2 g, of spice blend compared with 0 g spice blend.
CONCLUSIONS
A HFCM containing 6 g spice blend attenuated HFCM-induced postprandial IL-1β secretion in men with overweight/obesity.This trial was registered at clinicaltrials.gov as NCT03064958.",2020,There was a significant spice-by-time interaction on IL-1β,"['Men with Overweight or Obesity', 'men with overweight/obesity', 'Nonsmoking men (40-65 y old) with overweight/obesity (25 ≤ BMI ≤ 35\xa0kg/m2), elevated waist circumference (≥ 94\xa0cm), and ≥ 1 CVD risk factor were recruited for a 3-period crossover study ( n\xa0=\xa012']","['HFCM', 'carbohydrate meal (HFCM', 'High-Saturated-Fat, High-Carbohydrate Meal', 'HFCM containing 2\xa0g spice blend, or an HFCM containing 6\xa0g spice blend', 'basil, bay leaf, black pepper, cinnamon, coriander, cumin, ginger, oregano, parsley, red pepper, rosemary, thyme, and turmeric', 'HFCM (∼1000\xa0kcal, 33%\xa0kcal from saturated fat and 36%\xa0kcal from carbohydrate']","['IL-8', 'TNF-α', 'IL-1β secretion from LPS-stimulated PBMCs', 'Postprandial Proinflammatory Cytokine Secretion', 'percentage of CD14 +/Human', 'Peripheral blood mononuclear cells (PBMCs', 'IL-1β', 'postprandial IL-1β secretion', 'Leukocyte Antigen-DR isotype + (HLA-DR +) monocytes and proinflammatory cytokine concentrations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0037910', 'cui_str': 'Spices'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0600402', 'cui_str': 'Basil'}, {'cui': 'C0453244', 'cui_str': 'Bay Leaf'}, {'cui': 'C0162750', 'cui_str': 'Black Pepper'}, {'cui': 'C1112857', 'cui_str': 'Cinnamon'}, {'cui': 'C0162747', 'cui_str': 'Coriander'}, {'cui': 'C0524875', 'cui_str': 'Cumin'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0453263', 'cui_str': 'Oregano'}, {'cui': 'C0994493', 'cui_str': 'Parsley'}, {'cui': 'C0446306', 'cui_str': 'Bell Pepper'}, {'cui': 'C1262899', 'cui_str': 'Rosemary (substance)'}, {'cui': 'C1305848', 'cui_str': 'Thyme'}, {'cui': 'C0041356', 'cui_str': 'Tumeric'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0907223,There was a significant spice-by-time interaction on IL-1β,"[{'ForeName': 'Ester S', 'Initials': 'ES', 'LastName': 'Oh', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Connie J', 'Initials': 'CJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa063']
648,32201572,"Protocol for the Effectiveness of an Anesthesiology Control Tower System in Improving Perioperative Quality Metrics and Clinical Outcomes: the TECTONICS randomized, pragmatic trial.","Introduction: Perioperative morbidity is a public health priority, and surgical volume is increasing rapidly. With advances in technology, there is an opportunity to research the utility of a telemedicine-based control center for anesthesia clinicians that assess risk, diagnoses negative patient trajectories, and implements evidence-based practices. Objectives: The primary objective of this trial is to determine whether an anesthesiology control tower (ACT) prevents clinically relevant adverse postoperative outcomes including 30-day mortality, delirium, respiratory failure, and acute kidney injury. Secondary objectives are to determine whether the ACT improves perioperative quality of care metrics including management of temperature, mean arterial pressure, mean airway pressure with mechanical ventilation, blood glucose, anesthetic concentration, antibiotic redosing, and efficient fresh gas flow. Methods and analysis: We are conducting a single center, randomized, controlled, phase 3 pragmatic clinical trial. A total of 58 operating rooms are randomized daily to receive support from the ACT or not. All adults (eighteen years and older) undergoing surgical procedures in these operating rooms are included and followed until 30 days after their surgery. Clinicians in operating rooms randomized to ACT support receive decision support from clinicians in the ACT. In operating rooms randomized to no intervention, the current standard of anesthesia care is delivered. The intention-to-treat principle will be followed for all analyses. Differences between groups will be presented with 99% confidence intervals; p-values <0.005 will be reported as providing compelling evidence, and p-values between 0.05 and 0.005 will be reported as providing suggestive evidence. Registration: TECTONICS is registered on ClinicalTrials.gov, NCT03923699 ; registered on 23 April 2019.",2019,"With advances in technology, there is an opportunity to research the utility of a telemedicine-based control center for anesthesia clinicians that assess risk, diagnoses negative patient trajectories, and implements evidence-based practices. ",['All adults (eighteen years and older) undergoing surgical procedures in these operating rooms are included and followed until 30 days after their surgery'],"['anesthesiology control tower (ACT', 'Anesthesiology Control Tower System', 'ACT']","['Perioperative Quality Metrics and Clinical Outcomes', 'perioperative quality of care metrics including management of temperature, mean arterial pressure, mean airway pressure with mechanical ventilation, blood glucose, anesthetic concentration, antibiotic redosing, and efficient fresh gas flow', '30-day mortality, delirium, respiratory failure, and acute kidney injury']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C0428716', 'cui_str': 'Fresh gas flow (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}]",,0.307689,"With advances in technology, there is an opportunity to research the utility of a telemedicine-based control center for anesthesia clinicians that assess risk, diagnoses negative patient trajectories, and implements evidence-based practices. ","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'King', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Kannampallil', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Fritz', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Computer Science and Engineering, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Henrichs', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Politi', 'Affiliation': 'Department of Surgery, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Torres', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mickle', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Thaddeus P', 'Initials': 'TP', 'LastName': 'Budelier', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'McKinnon', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gregory', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Kheterpal', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Wildes', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.21016.1']
649,30461315,"Effects of Cognitive Behavioral Therapy for Insomnia on Sleep, Symptoms, Stress, and Autonomic Function Among Patients With Heart Failure.","Background : Insomnia is common among patients with stable heart failure (HF) and associated with inflammation and altered autonomic function. Purpose : The purposes of this study were to examine the effects of cognitive behavioral therapy for insomnia (CBT-I) on the Hypothalamic Pituitary (HPA) Axis, autonomic function, inflammation, and circadian rhythmicity and the associations between these biomarkers and insomnia, sleep characteristics, symptoms, functional performance, and sleep-related cognitions. Methods : We conducted a subanalysis of a pilot randomized controlled trial (RCT, NCT02827799) whose primary aim was to test the effects of CBT-I on insomnia. We randomized 51 patients with stable Class II-IV HF to CBT-I ( n = 30) or attention control ( n = 21). Participants completed wrist actigraphy and self-reported insomnia severity, sleep characteristics, sleep-related cognitions, daytime symptoms, and functional performance. We measured day and nighttime urinary free cortisol, melatonin sulfate, epinephrine, and norepinephrine at baseline, and two weeks after CBT-I and computed general linear models and partial correlations. Results : CBT-I had no effects on the biomarkers, but there were statistically significant negative cross-sectional correlations between the ratio of day and night urinary free cortisol and sleep disturbance, anxiety, fatigue, depression, and negative sleep cognitions. Increases in the ratio between day and night cortisol were associated with statistically significant improvements in fatigue, depression, sleep duration, and sleep-related cognitions. Conclusions : Biomarkers of stress and autonomic function are associated with sleep, sleep-related symptoms, and cognitions among people with chronic HF. Future studies are needed to identify potential causal relationships and the impact of sleep interventions.",2020,"Increases in the ratio between day and night cortisol were associated with statistically significant improvements in fatigue, depression, sleep duration, and sleep-related cognitions.
","['Patients With Heart Failure', 'people with chronic HF', 'patients with stable heart failure (HF', '51 patients with stable Class II-IV HF to CBT-I (n =\xa030) or attention control (n =\xa021']","['Cognitive Behavioral Therapy', 'cognitive behavioral therapy']","['wrist actigraphy and self-reported insomnia severity, sleep characteristics, sleep-related cognitions, daytime symptoms, and functional performance', 'Hypothalamic Pituitary (HPA) Axis, autonomic function, inflammation, and circadian rhythmicity and the associations between these biomarkers and insomnia, sleep characteristics, symptoms, functional performance, and sleep-related cognitions', 'Insomnia on Sleep, Symptoms, Stress, and Autonomic Function', 'nighttime urinary free cortisol, melatonin sulfate, epinephrine, and norepinephrine', 'fatigue, depression, sleep duration, and sleep-related cognitions', 'night urinary free cortisol and sleep disturbance, anxiety, fatigue, depression, and negative sleep cognitions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3853978'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031084', 'cui_str': 'Rhythmicity'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine (procedure)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",51.0,0.03938,"Increases in the ratio between day and night cortisol were associated with statistically significant improvements in fatigue, depression, sleep duration, and sleep-related cognitions.
","[{'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Redeker', 'Affiliation': 'Beatrice Renfield Term Professor of Nursing, Yale School of Nursing, West Haven, Connecticut.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Conley', 'Affiliation': 'Yale School of Nursing, Orange, CT.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Anderson', 'Affiliation': 'Yale Child Study Center, New Haven, CT.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cline', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andrews', 'Affiliation': 'Yale School of Nursing, Orange, CT.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mohsenin', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Yale School of Nursing, Orange, CT.'}]",Behavioral sleep medicine,['10.1080/15402002.2018.1546709']
650,32208960,"Randomized, Phase II Study of Trastuzumab Beyond Progression in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction Cancer: WJOG7112G (T-ACT Study).","PURPOSE
This study evaluated the continuous use of trastuzumab beyond progression (TBP) in human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (G/GEJ) cancer.
PATIENTS AND METHODS
Patients with HER2-positive advanced G/GEJ cancer refractory to first-line chemotherapy with trastuzumab in combination with fluoropyrimidine and platinum were eligible. Patients were randomly assigned to the paclitaxel (80 mg/m 2 , days 1, 8, and 15, every 4 weeks) or paclitaxel with trastuzumab (PT; initially 8 mg/kg followed by 6 mg/kg, every 3 weeks) arms. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), response rate, and safety. Biomarkers such as HER2 expression status in tumor tissue after first-line treatment, HER2 amplification evaluated in serum cell-free DNA, and soluble HER2 levels were analyzed.
RESULTS
Overall, 91 patients were allocated to the paclitaxel (n = 46) and PT (n = 45) arms. The median PFS in the paclitaxel and PT arms was 3.2 and 3.7 months, respectively (hazard ratio [HR], 0.91; 80% CI, 0.67 to 1.22; P = .33), and the median OS in both arms was 10 months (HR, 1.2; 95% CI, 0.75 to 2.0; P = .20). The overall response rates in the paclitaxel and PT arms were 32% and 33%, respectively ( P = 1.00), and safety was comparable between the 2 arms. On exploratory analyses, HER2 positivity of tumor tissues was lost after first-line chemotherapy in 11 (69%) of 16 patients whose tumor tissues were available, and circulating HER2 DNA amplification was detected in 41 (60%) of 68 patients. However, no biomarkers associated with efficacy of TBP were found.
CONCLUSION
The TBP strategy failed to improve PFS in patients with HER2-positive advanced G/GEJ cancer, and no beneficial biomarkers were found.",2020,"The overall response rates in the paclitaxel and PT arms were 32% and 33%, respectively ( P = 1.00), and safety was comparable between the 2 arms.","['patients with HER2-positive advanced G/GEJ cancer', 'human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (G/GEJ) cancer', 'Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction Cancer', 'Patients with HER2-positive advanced G/GEJ cancer refractory to first-line chemotherapy with trastuzumab in combination with fluoropyrimidine and platinum were eligible']","['paclitaxel', 'Trastuzumab', 'trastuzumab beyond progression (TBP', 'paclitaxel with trastuzumab (PT']","['progression-free survival (PFS', 'serum cell-free DNA, and soluble HER2 levels', 'overall response rates', 'overall survival (OS), response rate, and safety', 'safety', 'median OS', 'efficacy of TBP', 'HER2 positivity of tumor tissues', 'circulating HER2 DNA amplification', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0077021', 'cui_str': 'tributyl phosphate'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4289789', 'cui_str': 'Cell-Free Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0077021', 'cui_str': 'tributyl phosphate'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}]",91.0,0.0358433,"The overall response rates in the paclitaxel and PT arms were 32% and 33%, respectively ( P = 1.00), and safety was comparable between the 2 arms.","[{'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka; and Cancer Center, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Sukawa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Kashiwada', 'Affiliation': 'Department of Hematology/Oncology, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kawada', 'Affiliation': 'Department of Surgery, Kaizuka City Hospital, Osaka, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Horie', 'Affiliation': 'Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Kagawa University Faculty of Medicine, Kita-gun, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tanioka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Uchino', 'Affiliation': 'Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of GI Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tsukuda', 'Affiliation': 'Department of Oncology, Izumi City General Hospital, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Gastroenterology, National Health Organization, Mito Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Clinical Trial Coordination Unit and Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Division of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03077']
651,32209529,Help to Overcome Problems Effectively for Cancer Survivors: Development and Evaluation of a Digital Self-Management Program.,"BACKGROUND
People living with cancer face numerous psychosocial challenges, including cancer-related fatigue, fear of recurrence, and depression. There is a lack of digital interventions tailored to the needs of people living with all types of cancer. We developed a 6-week, digital, peer-delivered, self-management program: iHOPE (Help to Overcome Problems Effectively; where 'i' indicates the digital version of the program). The program is underpinned by positive psychology and cognitive behavioral therapy to meet these psychosocial challenges.
OBJECTIVE
This study aimed to assess the feasibility of the iHOPE program among people living with cancer. Program adherence and satisfaction along with changes in psychological distress and positive well-being were measured.
METHODS
A pre-post, acceptability, and feasibility design was used. People living with cancer (N=114) were recruited via a national cancer charity in the United Kingdom and were given access to the iHOPE program. Demographic and other participant characteristics were recorded. Participants completed digital measures at baseline and the end of the 6-week program for depression, anxiety, cancer-related fatigue, cancer worry or fear of cancer recurrence, positive mental well-being, hope, gratitude, and health status. The website's system recorded data on the usage of the program. Satisfaction with the program was also measured.
RESULTS
A total of 114 participants completed the baseline questionnaires. Of these, 70 people (61.4%) participated in all 6 sessions. The mean number of sessions undertaken was 5.0 (SD 1.5). Moreover, 44.7% (51/114) of participants completed at least three sessions and end-of-program outcome measures. A total of 59 participants completed the satisfaction questionnaire, where ≥90% (54/58) of participants reported that the program was easy to navigate and was well managed by the peer facilitators, and that they found the social networking tools useful. Preliminary efficacy testing among the 51 participants who completed baseline and postprogram outcome measures showed that postprogram scores decreased for depression, anxiety, cancer-related fatigue, and fear of recurrence (all P<.001) and increased for positive mental well-being (P<.001), hope (both P<.001), and gratitude (P=.02).
CONCLUSIONS
The feasibility evidence is promising, showing that the peer-delivered digital iHOPE program is acceptable and practical. Implementation of the iHOPE program on a wider scale will incorporate further research and development to maximize the completion rates of the measures. Initial effectiveness data suggest positive impacts on important cancer-related quality of life and mental well-being outcomes. A randomized controlled trial design with a longer follow-up is needed to confirm the potential of the iHOPE program for improving mental and physical health outcomes for cancer survivors.",2020,"Preliminary efficacy testing among the 51 participants who completed baseline and post-programme outcome measures showed that post-programme scores decreased for depression, anxiety, cancer related fatigue and fear of recurrence (all P<.001) and increased for positive mental wellbeing, hope (both P<.001) and gratitude (P=0.015).
","['cancer survivors', 'Cancer Survivors', 'Seventy people (61%) participated in all six sessions', 'people living with cancer', 'People living with cancer (n=114) were recruited via a national cancer charity in the United Kingdom and were given access to the iHOPE programme', 'One hundred and fourteen participants completed baseline questionnaires']",['iHOPE programme'],"['depression, anxiety, cancer-related fatigue, cancer ""worry"" or fear of cancer recurrence, positive mental wellbeing, hope, gratitude and health status', 'important cancer-related quality of life and mental wellbeing outcomes', 'satisfaction questionnaire', 'psychological distress and positive wellbeing', 'depression, anxiety, cancer related fatigue and fear of recurrence', 'mean number of sessions undertaken', 'positive mental wellbeing, hope (both P<.001) and gratitude']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}]",114.0,0.12117,"Preliminary efficacy testing among the 51 participants who completed baseline and post-programme outcome measures showed that post-programme scores decreased for depression, anxiety, cancer related fatigue and fear of recurrence (all P<.001) and increased for positive mental wellbeing, hope (both P<.001) and gratitude (P=0.015).
","[{'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Faculty of Health and Applied Science, University of the West of England, Bristol, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Wright', 'Affiliation': 'Faculty Research Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Moody', 'Affiliation': 'Faculty Research Centre for Arts, Memory and Communities, Faculty of Arts and Humanities, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Whiteman', 'Affiliation': 'UK Early Cancer Detection Consortium, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Clyne', 'Affiliation': 'Hope for The Community, Community Interest Company, The Enterprise Hub, Coventry, United Kingdom.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Pearce', 'Affiliation': 'Faculty of Health and Life Sciences, School of Psychological, Social and Behavioural Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Faculty Research Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}]",Journal of medical Internet research,['10.2196/17824']
652,31414245,CaringGuidance™ after breast cancer diagnosis eHealth psychoeducational intervention to reduce early post-diagnosis distress.,"PURPOSE
Significant cancer-related distress affects 30-60% of women diagnosed with breast cancer. Fewer than 30% of distressed patients receive psychosocial care. Unaddressed distress is associated with poor treatment adherence, reduced quality of life, and increased healthcare costs. This study aimed to evaluate the preliminary efficacy of a new web-based, psychoeducational distress self-management program, CaringGuidance™ After Breast Cancer Diagnosis, on newly diagnosed women's reported distress.
METHODS
One-hundred women, in five states, diagnosed with breast cancer within the prior 3 months, were randomized to 12 weeks of independent use of CaringGuidance™ plus usual care or usual care alone. The primary multidimensional outcome, distress, was measured with the Distress Thermometer (DT), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Impact of Events Scale (IES) at baseline and months 1, 2, and 3. Intervention usage was continually monitored by the data analytic system imbedded within CaringGuidance™.
RESULTS
Although multilevel models showed no significant overall effects, post hoc analysis showed significant group differences in slopes occurring between study months 2 and 3 on distress (F(1,70) = 4.91, p = .03, η 2 = .065) measured by the DT, and depressive symptoms (F(1, 76) = 4.25, p = .043, η 2 = .053) favoring the intervention.
CONCLUSIONS
Results provide preliminary support for the potential efficacy of CaringGuidance™ plus usual care over usual care alone on distress in women newly diagnosed with breast cancer. This analysis supports and informs future study of this self-management program aimed at filling gaps in clinical distress management.",2020,"This study aimed to evaluate the preliminary efficacy of a new web-based, psychoeducational distress self-management program, CaringGuidance™","['women newly diagnosed with breast cancer', 'One-hundred women, in five states, diagnosed with breast cancer within the prior 3\xa0months', 'women diagnosed with breast cancer']","['CaringGuidance™ plus usual care or usual care alone', 'CaringGuidance™ after breast cancer diagnosis eHealth psychoeducational intervention', 'CaringGuidance', 'new web-based, psychoeducational distress self-management program, CaringGuidance™']","['quality of life, and increased healthcare costs', 'distress, was measured with the Distress Thermometer (DT), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Impact of Events Scale (IES', 'DT, and depressive symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0039818', 'cui_str': 'Thermometers'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale (assessment scale)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",100.0,0.0487959,"This study aimed to evaluate the preliminary efficacy of a new web-based, psychoeducational distress self-management program, CaringGuidance™","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Lally', 'Affiliation': 'University at Buffalo School of Nursing, Buffalo, NY, USA. robin.lally@unmc.edu.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kupzyk', 'Affiliation': 'University of Nebraska Medical Center College of Nursing Biostatistician, 985330 Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Bellavia', 'Affiliation': 'Graduate School of Education, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hydeman', 'Affiliation': 'Department of Psychology, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'New York State Center of Excellence in Bioinformatics & Life Sciences, University at Buffalo Center for Computational Research, Buffalo, NY, USA.'}, {'ForeName': 'Vicki S', 'Initials': 'VS', 'LastName': 'Helgeson', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Erwin', 'Affiliation': 'Department of Oncology Health Disparity Research, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Mills', 'Affiliation': 'Nebraska Medicine, Department of Psychology, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Brown', 'Affiliation': 'School of Nursing, University at Buffalo, Buffalo, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05028-0']
653,32491924,Acute kinematics and kinetics changes to wearable resistance during change of direction among soccer players.,"This study determined the acute changes in kinematics and kinetics when an additional load equivalent to 5% body mass was attached to the torso during change of direction (COD). In this within-subject repeated measures study, 14 male soccer players (age: 18.29 ± 0.32 years) volunteered to participate. Subjects performed COD under two conditions in randomized order: (1) no WR, and (2) with WR. No significant differences between the loaded and unloaded conditions in actual COD angle, approach speed, braking time, propulsive time, contact time, COD completion time (all p > 0.05, ES = 0.05-0.11), and all measured kinematic parameters (all p > 0.05, ES = 0-0.18). Nonetheless, ankle plantar/dorsi flexion ROM had possibly small increase in the loaded condition (ES = 0.24). Kinetics analysis has shown that the loaded condition was likely to have small increase in relative peak vertical propulsive ground reaction force (GRF, p = 0.11, ES = 0.41), and possible small increases in relative peak braking GRF (vertical: p = 0.21, ES = 0.42; total: p = 0.22, ES = 0.38), relative peak total propulsive GRF (p = 0.24, ES = 0.26), and relative braking impulse (horizontal, vertical, and total; p = 0.27-0.41, ES = 0.26-0.28). WR did not significantly change the acute movement techniques, meanwhile induced small increases in important kinetic stimuli for potential adaptation in COD.",2020,"No significant differences between the loaded and unloaded conditions in actual COD angle, approach speed, braking time, propulsive time, contact time, COD completion time (all p > 0.05, ES = 0.05-0.11), and all measured kinematic parameters (all p > 0.05, ES = 0-0.18).","['soccer players', '14 male soccer players (age: 18.29\xa0±\xa00.32\xa0years) volunteered to participate']",[],"['kinematic parameters', 'relative braking impulse', 'relative peak total propulsive GRF', 'actual COD angle, approach speed, braking time, propulsive time, contact time, COD completion time']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517448', 'cui_str': '0.32'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]",[],"[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",14.0,0.0515053,"No significant differences between the loaded and unloaded conditions in actual COD angle, approach speed, braking time, propulsive time, contact time, COD completion time (all p > 0.05, ES = 0.05-0.11), and all measured kinematic parameters (all p > 0.05, ES = 0-0.18).","[{'ForeName': 'Xueliang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'China Football College, Beijing Sport University , Beijing, China.'}, {'ForeName': 'Chunman', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'China Football College, Beijing Sport University , Beijing, China.'}, {'ForeName': 'Yixiong', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'AI Sports Engineering Lab, School of Sports Engineering, Beijing Sport University , Beijing, China.'}, {'ForeName': 'Del P', 'Initials': 'DP', 'LastName': 'Wong', 'Affiliation': 'Titi Sport Technology , Shenzhen, China.'}]",Research in sports medicine (Print),['10.1080/15438627.2020.1770761']
654,31553639,Treatment of Childhood Nasopharyngeal Carcinoma With Induction Chemotherapy and Concurrent Chemoradiotherapy: Results of the Children's Oncology Group ARAR0331 Study.,"PURPOSE
The treatment of childhood nasopharyngeal carcinoma has been adapted from adult regimens; pediatric-specific studies are limited. The ARAR0331 study sought to evaluate the impact of induction chemotherapy (IC) and concurrent chemoradiotherapy (CCR).
PATIENTS AND METHODS
Patients with American Joint Committee on Cancer stages IIb to IV were scheduled to receive three cycles of IC with cisplatin and fluorouracil, followed by CCR with three cycles of cisplatin. Patients with complete or partial response to IC received 61.2 Gy to the nasopharynx and neck, and patients with stable disease received 71.2 Gy.
RESULTS
Between February 2006 and January 2012, 111 patients (75 male) were enrolled. Median age was 15 years, and 46.8% of the patients were African American. After a feasibility analysis, the study was amended to reduce cisplatin to two cycles during CCR. The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively. The 5-year EFS for stages IIb, III, and IV were 100%, 82.8%, and 82.7%, respectively. The 5-year cumulative incidence estimates of local, distant, and combined relapse were 3.7%, 8.7%, and 1.8%, respectively. Patients treated with three versus two CCR cycles of cisplatin had improved 5-year postinduction EFS (90.7% v 81.2%, P = .14).
CONCLUSION
Patients in ARAR0331 were characterized by advanced disease and by a high proportion of black children and adolescents. Treatment with IC and CRT resulted in excellent outcomes. A radiation dose reduction is possible for patients responding to IC. Although the outcomes are comparable, we observed a trend toward decreased EFS for patients assigned to receive fewer doses of cisplatin during CCR.",2019,"The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively.","['Childhood Nasopharyngeal Carcinoma', 'Between February 2006 and January 2012, 111 patients (75 male) were enrolled', 'Median age was 15 years, and 46.8% of the patients were African American', 'Patients with American Joint Committee on Cancer stages IIb to IV']","['IC with cisplatin and fluorouracil, followed by CCR with three cycles of cisplatin', 'induction chemotherapy (IC) and concurrent chemoradiotherapy (CCR', 'Induction Chemotherapy and Concurrent Chemoradiotherapy', 'cisplatin', 'IC and CRT']","['5-year cumulative incidence estimates of local, distant, and combined relapse', '5-year event-free survival (EFS) and overall survival estimates', '5-year EFS', '5-year postinduction EFS']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",111.0,0.110512,"The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodriguez-Galindo', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Krailo', 'Affiliation': ""Children's Oncology Group, Monrovia, CA.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Krasin', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Children's Oncology Group, Monrovia, CA.""}, {'ForeName': 'M Beth', 'Initials': 'MB', 'LastName': 'McCarville', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hicks', 'Affiliation': ""Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Pashankar', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Alberto S', 'Initials': 'AS', 'LastName': 'Pappo', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01276']
655,30958012,Mechanisms of behavior change in a brief dual-target motivational intervention: Reduction in alcohol use mediates intervention effects on risky sex.,"To examine the mechanisms underlying the efficacy of a dual-target motivational intervention (MI) to reduce heavy drinking and risky sex. A priori hypotheses were that: increases in alcohol-related readiness to change (RTC) and self-efficacy would mediate the effect of MI on alcohol use; increases in sex-related RTC and self-efficacy would mediate the effect of MI on risky sex; and reductions in alcohol use would mediate reductions in risky sex. Patients in Emergency Departments who screened positive for heavy drinking and risky sex were randomly assigned to receive MI or brief advice. RTC and self-efficacy were assessed at baseline and immediately postintervention. Alcohol use and sexual behavior was assessed at baseline, 3-, 6-, and 9-month follow up. Single- and serial-mediation models were tested. Patients who received MI had higher postintervention RTC and self-efficacy, but neither mechanism mediated the effects of MI on behavioral outcomes. Reduction in heavy drinking mediated the effect of MI on frequency of sex under the influence (SUI). Further, the effect of MI on condomless sex was mediated by an indirect path in which reductions in heavy drinking at 3 months predicted less SUI at 6 months, which in turn predicted reduction in condomless sex at 9-months. Although some effect of dual-target MI on risky sex is independent of drinking, treatment-related reduction in heavy drinking does account for a significant portion of reduction in risky sex, providing support for the utility of this intervention in patient populations where heavy drinking and risky sex co-occur. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Patients who received MI had higher postintervention RTC and self-efficacy, but neither mechanism mediated the effects of MI on behavioral outcomes.",['Patients in Emergency Departments who screened positive for heavy drinking and risky sex'],"['dual-target motivational intervention (MI', 'MI or brief advice']","['heavy drinking and risky sex', 'postintervention RTC and self-efficacy', 'RTC and self-efficacy', 'risky sex', 'Alcohol use and sexual behavior']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.0148183,"Patients who received MI had higher postintervention RTC and self-efficacy, but neither mechanism mediated the effects of MI on behavioral outcomes.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Celio', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, State University of New York.'}, {'ForeName': 'Nancy P', 'Initials': 'NP', 'LastName': 'Barnett', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000461']
656,32162448,Ultrasonographic evaluation of gastric emptying after ingesting carbohydrate-rich drink in young children: A randomized crossover study.,"BACKGROUND
A recent consensus statement in Europe has suggested that the fasting time for clear liquid in children can be shortened to 1 hour before a surgery. However, the study to show that 1-hour fasting time for clear fluids is safe in young children is still lacking. This study aimed to investigate the gastric emptying time for carbohydrate-rich drink and regular 5% glucose solution in children aged 3-7 years.
METHODS
After overnight fasting, individuals were randomly assigned to ingest 5 mL kg -1 of either carbohydrate-rich drink or 5% glucose solution. One week later, the same subjects were asked to ingest the other one. Ultrasonography was performed to examine the gastric contents. Gastric antral cross-sectional area was measured, and the gastric fluid volume was calculated before and after fluid ingestion within 120 minutes. The primary outcome was the gastric emptying time for both the clear fluids calculated using the antral cross-sectional area and logarithms of gastric fluid volume. The degrees of thirst and hunger of two drinks were evaluated using a visual analogue scale as the secondary outcomes.
RESULTS
Data from 16 individuals were analyzed. In the glucose solution group, the antral cross-sectional area and logarithms of gastric fluid volume returned to baseline at 30 minutes after ingestion. However, in the carbohydrate-rich drink group, the median [interquartile range; range] antral cross-sectional area (3.69 [2.64-5.15; 1.83-8.93] cm 2 vs 2.41 [2.10-2.96; 1.81-4.37] cm 2 , P < .001) and mean (95% confidence interval) logarithms of gastric fluid volume (2.54 [2.30-2.79] mL vs 2.12 [1.94-2.30] mL, P = .048) were still higher than at 60 minutes and returned to the baseline values at 90 minutes after ingestion, respectively. The degree of thirst was lower in the glucose solution group than that in the carbohydrate-rich drink group.
CONCLUSIONS
Gastric emptying of carbohydrate-rich drink is slower than that of 5% glucose solution but the residual gastric fluid volume is low one hour after ingestion of 5 mL kg -1 of either fluid.",2020,"In the glucose solution group, the antral cross-sectional area and logarithms of gastric fluid volume returned to baseline at 30 minutes after ingestion.","['children aged 3-7\xa0years', 'young children']","['carbohydrate-rich drink', 'ingest 5\xa0mL\xa0kg -1 of either carbohydrate-rich drink or 5% glucose solution', 'Ultrasonography', 'carbohydrate-rich drink and regular 5% glucose solution']","['gastric emptying time for both the clear fluids calculated using the antral cross-sectional area and logarithms of gastric fluid volume', 'Gastric antral cross-sectional area', 'gastric fluid volume', 'gastric emptying time', 'antral cross-sectional area and logarithms of gastric fluid volume', 'residual gastric fluid volume', 'degree of thirst']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0453847', 'cui_str': 'Clear fluid (substance)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}]",16.0,0.106341,"In the glucose solution group, the antral cross-sectional area and logarithms of gastric fluid volume returned to baseline at 30 minutes after ingestion.","[{'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Qiu', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ru-Ping', 'Initials': 'RP', 'LastName': 'Dai', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Paediatric anaesthesia,['10.1111/pan.13853']
657,30282103,Risk of Ischemic Placental Disease in Relation to Family History of Preeclampsia.,"OBJECTIVE
To assess the risk of ischemic placental disease (IPD) including preeclampsia, small for gestational age (SGA), and abruption, in relation to preeclampsia in maternal grandmother, mother, and sister(s).
STUDY DESIGN
We performed a secondary analysis of data from a randomized trial of vitamins C and E for preeclampsia prevention. Data on family history of preeclampsia were based on recall by the proband. The associations between family history of preeclampsia and the odds of IPD were evaluated from alternating logistic regressions.
RESULTS
Of the 9,686 women who delivered nonmalformed, singleton live births, 17.1% had IPD. Probands provided data on preeclampsia in 55.5% ( n = 5,374) on all three family members, 26.5% ( n = 2,562) in mother and sister(s) only, and 11.6% ( n = 1,125) in sister(s) only. The pairwise odds ratio (pOR) of IPD was 1.16 (95% confidence interval [CI]: 1.00-1.36) if one or more of the female relatives had preeclampsia. The pORs of preeclampsia were 1.54 (95% CI: 1.12-2.13) and 1.35 (95% CI: 1.03-1.77) if the proband's mother or sister(s) had a preeclamptic pregnancy, respectively, but no associations were seen for SGA infant or abruption.
CONCLUSION
This study suggests that IPD may share a predisposition with preeclampsia, suggesting a familial inheritance.",2019,"Probands provided data on preeclampsia in 55.5% ( n = 5,374) on all three family members, 26.5% ( n = 2,562) in mother and sister(s) only, and 11.6% ( n = 1,125) in sister(s) only.","['9,686 women who delivered nonmalformed, singleton live births, 17.1% had IPD']",['vitamins C and E'],"['pairwise odds ratio (pOR) of IPD', 'pORs of preeclampsia', 'preeclampsia', 'preeclamptic pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",[],"[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",9686.0,0.106824,"Probands provided data on preeclampsia in 55.5% ( n = 5,374) on all three family members, 26.5% ( n = 2,562) in mother and sister(s) only, and 11.6% ( n = 1,125) in sister(s) only.","[{'ForeName': 'Cande V', 'Initials': 'CV', 'LastName': 'Ananth', 'Affiliation': 'Department of Obstetrics and Gynecology, Vagelos College of Physicians and Surgeons, Joseph L. Mailman School of Public Health, Columbia University, New York, New York.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Jablonski', 'Affiliation': 'Department of Obstetrics and Gynecology, Biostatistics Center, The George Washington University, Washington, District of Columbia.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Myatt', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Roberts', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Leveno', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Mercer', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Ramin', 'Affiliation': ""Department of Obstetrics and Gynecology, Children's Memorial Hermann Hospital, The University of Texas Health Science Center at Houston, Houston, Texas.""}, {'ForeName': 'Marshall W', 'Initials': 'MW', 'LastName': 'Carpenter', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Samuels', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sciscione', 'Affiliation': 'Department of Obstetrics and Gynecology, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Tolosa', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Sorokin', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0038-1672177']
658,31010875,"Changes in Serum Calcitonin Concentrations, Incidence of Medullary Thyroid Carcinoma, and Impact of Routine Calcitonin Concentration Monitoring in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL).","OBJECTIVE
Increases in serum calcitonin, a tumor marker for medullary thyroid carcinoma (MTC), have been associated with glucagon-like peptide 1 receptor agonist use in some preclinical studies. We report calcitonin changes in exenatide-treated and placebo-administered participants and MTC incidence in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) and consider the impact of within-trial calcitonin monitoring.
RESEARCH DESIGN AND METHODS
EXSCEL participants were randomized 1:1 to once-weekly exenatide 2 mg or placebo. Serum calcitonin was measured at baseline (with trial medication discontinued if >40 ng/L) and annually thereafter (with trial medication discontinued if ≥50 ng/L). Median calcitonin concentrations were calculated at each time point, and thyroid malignancies were collected prospectively. Data regarding follow-up after an elevated calcitonin were collected retrospectively.
RESULTS
At baseline, 52 (30 exenatide and 22 placebo) participants had calcitonin >40 ng/L, and during follow-up an additional 23 participants (15 exenatide and 8 placebo) had calcitonin ≥50 ng/L in the intention-to-treat population. Median calcitonin concentrations were similar between treatment groups at baseline with no increase over time. Confirmed MTC occurred in three participants (2 exenatide and 1 placebo), all of whom had significantly elevated baseline calcitonin values (413, 422, and 655 ng/L).
CONCLUSIONS
During a median 3.2 years' follow-up, no change in serum calcitonin was seen with exenatide therapy. The three confirmed cases of MTC all occurred in participants with markedly elevated baseline calcitonin levels, measured prior to trial medication administration. Regular calcitonin monitoring identified no additional cases of MTC, suggesting no benefit of routine calcitonin monitoring during exenatide treatment.",2019,"At baseline, 52 (30 exenatide and 22 placebo) participants had calcitonin >40 ng/L, and during follow-up an additional 23 participants (15 exenatide and 8 placebo) had calcitonin ≥50 ng/L in the intention-to-treat population.","['EXSCEL participants', '≥50 ng/L in the intention-to-treat population', 'participants had calcitonin >40 ng/L, and during follow-up an additional 23 participants (15']","['exenatide 2 mg or placebo', 'calcitonin', 'placebo', 'exenatide and 22 placebo', 'exenatide and 8 placebo', 'exenatide-treated and placebo']","['Serum calcitonin', 'serum calcitonin', 'Median calcitonin concentrations', 'Serum Calcitonin Concentrations, Incidence of Medullary Thyroid Carcinoma, and Impact of Routine Calcitonin Concentration Monitoring', 'elevated baseline calcitonin values']","[{'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0073994', 'cui_str': 'calcitonin (salmon synthetic)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C4026820', 'cui_str': 'exenatide 2 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073994', 'cui_str': 'calcitonin (salmon synthetic)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0863135', 'cui_str': 'Serum calcitonin measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0073994', 'cui_str': 'calcitonin (salmon synthetic)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0238462', 'cui_str': 'Medullary thyroid cancer (MTC)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.125282,"At baseline, 52 (30 exenatide and 22 placebo) participants had calcitonin >40 ng/L, and during follow-up an additional 23 participants (15 exenatide and 8 placebo) had calcitonin ≥50 ng/L in the intention-to-treat population.","[{'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Rishi A', 'Initials': 'RA', 'LastName': 'Patel', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Vivian P', 'Initials': 'VP', 'LastName': 'Thompson', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gustavson', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ohman', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Gagel', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, TX.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc18-2028']
659,31543516,"Calcium: magnesium intake ratio and colorectal carcinogenesis, results from the prostate, lung, colorectal, and ovarian cancer screening trial.","BACKGROUND
We aimed to evaluate the associations between calcium and various stages of colorectal carcinogenesis and whether these associations are modified by the calcium to magnesium (Ca:Mg) ratio.
METHODS
We tested our hypotheses in the prostate lung, colorectal and ovarian cancer screening trial.
RESULTS
Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend = 0.05). This inverse trend was mainly in participants with Ca:Mg ratios between 1.7 and 2.5 (P- trend = 0.05). No significant associations were observed for metachronous adenoma. Calcium intake was inversely associated with CRC (P- trend = 0.03); the association was primarily present for distal CRC (P- trend = 0.01). The inverse association between calcium and distal CRC was further modified by the Ca:Mg ratio (P- interaction < 0.01); significant dose-response associations were found only in participants with a Ca:Mg ratio between 1.7 and 2.5 (P- trend = 0.04). No associations for calcium were found in the Ca:Mg ratio above 2.5 or below 1.7.
CONCLUSION
Higher calcium intake may be related to reduced risks of incident advanced and/or synchronous adenoma and incident distal CRC among subjects with Ca:Mg intake ratios between 1.7 and 2.5.",2019,"RESULTS
Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend = 0.05).","['subjects with Ca', 'participants with Ca']",['Calcium: magnesium'],"['Calcium intake', 'Mg intake ratios', 'metachronous adenoma']",[],"[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",,0.0314611,"RESULTS
Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend = 0.05).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ayush', 'Initials': 'A', 'LastName': 'Giri', 'Affiliation': 'Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Xiangzhu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Medicine, Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Xingyi', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Ness', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Seidner', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Giovannucci', 'Affiliation': 'Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Todd L', 'Initials': 'TL', 'LastName': 'Edwards', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. qi.dai@vanderbilt.edu.'}]",British journal of cancer,['10.1038/s41416-019-0579-2']
660,32401335,Breast shield design impacts milk removal dynamics during pumping: A randomised controlled non-inferiority trial.,"INTRODUCTION
While many studies have investigated the importance of optimising pumping patterns for milk removal, the influence of breast shield design on milk removal has not been the focus of extensive investigation. This study aimed to determine the effectiveness of breast shields with either a 105° or a 90° flange opening angle on breast drainage and milk volume expressed during pumping.
MATERIAL AND METHODS
This study was a cross-over, randomised controlled non-inferiority trial (Registration; NCT03091985). Mothers (n = 49) of breastfeeding infants participated in the study over two study sessions. Participants were randomly assigned to pump both breasts simultaneously for 15 minutes with either the 105° or 90° breast shield in the first session, and the other shield in the second session. Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields were assessed after 15 minutes of pumping. Intention-to-treat and per protocol analyses were performed to determine if the 105° breast shield was non-inferior to the 90° breast shield for breast drainage and volume expressed. Perceived comfort was assessed via questionnaire.
RESULTS
The 105° breast shield was both non-inferior and superior compared to the standard 90° shield for breast drainage (intention-to-treat, 3.87% (0.01-7.72), P = .049) and volume expressed (intention-to-treat, 9.14 mL (1.37-16.91), P=.02). In addition, the 105° shield was rated as feeling more comfortable (P < .001) and as having an improved fit to the breast (P < .001) compared to the 90° shield.
CONCLUSIONS
Expressing with the 105° breast shield was more efficient, effective and comfortable compared to the 90° shield. Breast shield design can significantly impact pumping outcomes, and an opening angle of 105° improves both the dynamics and comfort of milk removal.",2020,"In addition, the 105° shield was rated as feeling more comfortable (p<.001) and as having an improved fit to the breast (p<.001) compared to the 90° shield.
",['Mothers (n=49) of breastfeeding infants participated in the study over two study sessions'],[],"['Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields', 'feeling more comfortable (p<.001) and as having an improved fit to the breast', 'Perceived comfort']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0222605', 'cui_str': 'Both breasts'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0633338,"In addition, the 105° shield was rated as feeling more comfortable (p<.001) and as having an improved fit to the breast (p<.001) compared to the 90° shield.
","[{'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Sakalidis', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Ivarsson', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Haynes', 'Affiliation': 'Clinical Trials Unit (CTU) Bern, Faculty of Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Jäger', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Nania G', 'Initials': 'NG', 'LastName': 'Schärer-Hernández', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Leon R', 'Initials': 'LR', 'LastName': 'Mitoulas', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Prime', 'Affiliation': 'Medela AG, Baar, Switzerland.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13897']
661,32403062,"The effect of viewing challenging ""reality check"" Instagram comments on women's body image.","One increasing trend on social media is the posting of challenging or ""reality check"" comments about idealized photos of thin and attractive women. The aim of the present study was to experimentally investigate the effect of viewing such reality check comments after a positive appearance comment on young women's body image. Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment. In contrast to prediction, viewing positive appearance comments did not elicit more body dissatisfaction than viewing images with no comments. As predicted, however, adding a reality check comment did reduce body dissatisfaction relative to the positive appearance comment alone. It was concluded that making and viewing reality check comments provides a potential way for women to mitigate some of the negative effect of Instagram imagery.",2020,"Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment.","[""young women's body image"", 'Participants were 192 women aged 17-25 years', ""women's body image""]","['view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment', 'viewing challenging ""reality check"" Instagram comments']",['body dissatisfaction'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]",192.0,0.0251286,"Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment.","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia. Electronic address: Marika.Tiggemann@flinders.edu.au.'}, {'ForeName': 'Vasiliki Georgia', 'Initials': 'VG', 'LastName': 'Velissaris', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia.'}]",Body image,['10.1016/j.bodyim.2020.04.004']
662,32403066,A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors.,"OBJECTIVE
To assess the efficacy of aerobic exercise training to improve controlled attention, information processing speed and neural communication during increasing task load and rest in pediatric brain tumor survivors (PBTS) treated with cranial radiation.
METHODS
Participants completed visual-motor Go and Go/No-Go tasks during magnetoencephalography recording prior to and following the completion of 12-weeks of exercise training. Exercise-related changes in response accuracy and visual-motor latency were evaluated with Linear Mixed models. The Phase Lag Index (PLI) was used to estimate functional connectivity during task performance and rest. Changes in PLI values after exercise training were assessed using Partial Least Squares analysis.
RESULTS
Exercise training predicted sustained (12-weeks) improvement in response accuracy (p<0.05) during No-Go trials. Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials. Significant changes in response latency and resting state connectivity were not detected.
CONCLUSION
These findings support the efficacy of aerobic exercise to improve controlled attention and enhance functional mechanisms under increasing task load in participants.
SIGNIFICANCE
It may be possible to harness the beneficial effects of exercise as therapy to promote cognitive recovery and enhance brain function in PBTS.",2020,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"['pediatric brain tumor survivors (PBTS) treated with cranial radiation', 'Participants completed visual-motor Go and Go', 'pediatric brain tumor survivors']","['exercise training', 'aerobic exercise', 'Exercise training', 'aerobic exercise training']","['PLI values', 'Phase Lag Index (PLI', 'cognition and neural communication', 'response accuracy and visual-motor latency', 'response accuracy', 'Altered functional connectivity', 'response latency and resting state connectivity']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",,0.0354978,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: elizabeth.cox@sickkids.ca.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Bells', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: sonya.bells@sickkids.ca.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, 1200 Main Street W., Hamilton, ON L8N 3Z5, Canada. Electronic address: timmonbw@mcmaster.ca.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, SickKids, 555 University Avenue, Toronto, ON M5G 1X8, Canada. Electronic address: suzanne.laughlin@sickkids.ca.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: eric.bouffet@sickkids.ca.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: cynthia.demedeiros@sickkids.ca.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Beera', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: kirangbeera@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harasym', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: harasyd@mcmaster.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: donald.mabbott@sickkids.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.03.027']
663,32403115,Delayed iron does not alter cognition or behavior among children with severe malaria and iron deficiency.,"BACKGROUND
Malaria and iron deficiency (ID) in childhood are both associated with cognitive and behavioral dysfunction. The current standard of care for children with malaria and ID is concurrent antimalarial and iron therapy. Delaying iron therapy until inflammation subsides could increase iron absorption but also impair cognition.
METHODS
In this study, Ugandan children 18 months to 5 years old with cerebral malaria (CM, n = 79), severe malarial anemia (SMA, n = 77), or community children (CC, n = 83) were enrolled and tested for ID. Children with ID were randomized to immediate vs. 28-day delayed iron therapy. Cognitive and neurobehavioral outcomes were assessed at baseline and 6 and 12 months (primary endpoint) after enrollment.
RESULTS
All children with CM or SMA and 35 CC had ID (zinc protoporphyrin concentration ≥80 μmol/mol heme). No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
CONCLUSIONS
Children with CM or SMA and ID who received immediate vs. delayed iron therapy had similar cognitive and neurobehavioral outcomes at 12-month follow-up.
IMPACT
The optimal time to provide iron therapy in children with severe malaria is not known. The present study shows that delay of iron treatment to 28 days after the malaria episode, does not lead to worse cognitive or behavioral outcomes at 12-month follow-up.The study contributes new data to the ongoing discussion of how best to treat ID in children with severe malaria.",2020,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","['children with severe malaria and iron deficiency', 'Ugandan children 18 months to 5 years old with cerebral malaria (CM, n\u2009=\u200979), severe malarial anemia (SMA, n\u2009=\u200977), or community children (CC, n\u2009=\u200983) were enrolled and tested for ID', 'Children with ID', 'children with severe malaria']",['immediate vs. 28-day delayed iron therapy'],"['cognitive and neurobehavioral outcomes', 'Cognitive and neurobehavioral outcomes', 'cognition or behavior', 'cognitive or behavioral outcomes', 'overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024534', 'cui_str': 'Cerebral malaria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.106877,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': ""Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Ssenkusu', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nakasujja', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kroupina', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bangirana', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA. chjohn@iu.edu.'}]",Pediatric research,['10.1038/s41390-020-0957-8']
664,32401715,"Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial.","BACKGROUND
Effective antiviral therapy is important for tackling the coronavirus disease 2019 (COVID-19) pandemic. We assessed the efficacy and safety of combined interferon beta-1b, lopinavir-ritonavir, and ribavirin for treating patients with COVID-19.
METHODS
This was a multicentre, prospective, open-label, randomised, phase 2 trial in adults with COVID-19 who were admitted to six hospitals in Hong Kong. Patients were randomly assigned (2:1) to a 14-day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international units of interferon beta-1b on alternate days (combination group) or to 14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h (control group). The primary endpoint was the time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT04276688.
FINDINGS
Between Feb 10 and March 20, 2020, 127 patients were recruited; 86 were randomly assigned to the combination group and 41 were assigned to the control group. The median number of days from symptom onset to start of study treatment was 5 days (IQR 3-7). The combination group had a significantly shorter median time from start of study treatment to negative nasopharyngeal swab (7 days [IQR 5-11]) than the control group (12 days [8-15]; hazard ratio 4·37 [95% CI 1·86-10·24], p=0·0010). Adverse events included self-limited nausea and diarrhoea with no difference between the two groups. One patient in the control group discontinued lopinavir-ritonavir because of biochemical hepatitis. No patients died during the study.
INTERPRETATION
Early triple antiviral therapy was safe and superior to lopinavir-ritonavir alone in alleviating symptoms and shortening the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19. Future clinical study of a double antiviral therapy with interferon beta-1b as a backbone is warranted.
FUNDING
The Shaw-Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine.",2020,Adverse events included self-limited nausea and diarrhoea with no difference between the two groups.,"['patients with COVID-19', '127 patients were recruited; 86', 'adults with COVID-19 who were admitted to six hospitals in Hong Kong', 'Between Feb 10 and March 20, 2020', 'patients admitted to hospital with COVID-19', 'patients with mild to moderate COVID-19']","['lopinavir-ritonavir alone', 'lopinavir 400 mg and ritonavir', 'interferon beta-1b, lopinavir-ritonavir, and ribavirin', 'combined interferon beta-1b, lopinavir-ritonavir, and ribavirin', 'lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin', 'lopinavir-ritonavir']","['self-limited nausea and diarrhoea', 'shorter median time', 'efficacy and safety', 'time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population', 'duration of viral shedding and hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0992889', 'cui_str': 'Ritonavir 100 MG'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",127.0,0.118203,Adverse events included self-limited nausea and diarrhoea with no difference between the two groups.,"[{'ForeName': 'Ivan Fan-Ngai', 'Initials': 'IF', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Cheung', 'Initials': 'KC', 'LastName': 'Lung', 'Affiliation': 'Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Eugene Yuk-Keung', 'Initials': 'EY', 'LastName': 'Tso', 'Affiliation': 'Department of Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tom Wai-Hin', 'Initials': 'TW', 'LastName': 'Chung', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Man-Yee', 'Initials': 'MY', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Yuk-Yung', 'Initials': 'YY', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Anthony Raymond', 'Initials': 'AR', 'LastName': 'Tam', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Hoi-Ping', 'Initials': 'HP', 'LastName': 'Shum', 'Affiliation': 'Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alan Ka-Lun', 'Initials': 'AK', 'LastName': 'Wu', 'Affiliation': 'Department of Microbiology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Kit-Man', 'Initials': 'KM', 'LastName': 'Sin', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Shing', 'Initials': 'WS', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Lam', 'Initials': 'WL', 'LastName': 'Law', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'David Christopher', 'Initials': 'DC', 'LastName': 'Lung', 'Affiliation': 'Department of Microbiology, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sin', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Yeung', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Cyril Chik-Yan', 'Initials': 'CC', 'LastName': 'Yip', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Ricky Ruiqi', 'Initials': 'RR', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Agnes Yim-Fong', 'Initials': 'AY', 'LastName': 'Fung', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Erica Yuen-Wing', 'Initials': 'EY', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kit-Hang', 'Initials': 'KH', 'LastName': 'Leung', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Jonathan Daniel', 'Initials': 'JD', 'LastName': 'Ip', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Allen Wing-Ho', 'Initials': 'AW', 'LastName': 'Chu', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Wan-Mui', 'Initials': 'WM', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Anthony Chin-Ki', 'Initials': 'AC', 'LastName': 'Ng', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Microbiology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Microbiology, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tak-Chiu', 'Initials': 'TC', 'LastName': 'Wu', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Johnny Wai-Man', 'Initials': 'JW', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wing-Wah', 'Initials': 'WW', 'LastName': 'Yan', 'Affiliation': 'Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Ming', 'Initials': 'WM', 'LastName': 'Chan', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Jasper Fuk-Woo', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Albert Kwok-Wai', 'Initials': 'AK', 'LastName': 'Lie', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Owen Tak-Yin', 'Initials': 'OT', 'LastName': 'Tsang', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Vincent Chi-Chung', 'Initials': 'VC', 'LastName': 'Cheng', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Tak-Lun', 'Initials': 'TL', 'LastName': 'Que', 'Affiliation': 'Department of Microbiology, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Chak-Sing', 'Initials': 'CS', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Hung', 'Initials': 'KH', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kelvin Kai-Wang', 'Initials': 'KK', 'LastName': 'To', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Yung', 'Initials': 'KY', 'LastName': 'Yuen', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China. Electronic address: kyyuen@hku.hk.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31042-4']
665,32201165,Effectiveness of a Smartphone Application as a Support Tool for Patients Undergoing Breast Cancer Chemotherapy: A Randomized Controlled Trial.,"BACKGROUND
Outpatients undergoing cancer chemotherapy experience anxiety related to adverse drug reactions that they can experience at home. We developed a breast cancer patient support system (BPSS) application (app). The BPSS app chronologically and quantitatively records patients' subjective and objective symptoms during breast cancer chemotherapy, with the goal of providing supportive management for adverse drug reactions. The present study examined whether the BPSS app is an effective tool for supporting patients undergoing chemotherapy.
PATIENTS AND METHODS
A total of 102 patients undergoing chemotherapy at the Showa University Hospital (Tokyo, Japan) were enrolled in the present order- and age-controlled clinical trial and randomized into BPSS or no-BPSS app groups. The patients underwent 4 courses of chemotherapy. The primary outcome was the change in the hospital anxiety and depression scale score, which was assessed directly before and after the 4 courses of chemotherapy. Other outcomes included health literacy (measured using the 14-item health literacy scale (HLS-14), side effects, and app adherence.
RESULTS
Of the 102 patients, 95 completed the present study. No significant improvement was seen in anxiety, depression, or health literacy at the end of treatment between the BPSS and no-BPSS app groups. Overall, 1868 side effects were reported. When the patients' records were compared with the medical staff records, the analysis revealed that the medical staff had underestimated some grade 3 symptoms.
CONCLUSION
The BPSS app is a feasible tool for patients with breast cancer and might be useful as a support tool for information sharing between patients and medical staff in an effort to optimize chemotherapy and deliver suitable patient care and support.",2020,"No significant improvement was seen in anxiety, depression, or health literacy at the end of treatment between the BPSS and no-BPSS app groups.","['Patients Undergoing Breast Cancer Chemotherapy', '102 patients', '102 patients undergoing chemotherapy at the Showa University Hospital (Tokyo, Japan) were enrolled in the present order- and age-controlled clinical trial and randomized into BPSS or no-BPSS app groups', 'patients undergoing chemotherapy', 'Outpatients undergoing cancer chemotherapy experience anxiety', 'patients with breast cancer']","['breast cancer patient support system (BPSS) application (app', 'chemotherapy', 'Smartphone Application']","['anxiety, depression, or health literacy', 'change in the hospital anxiety and depression scale score', 'health literacy (measured using the 14-item health literacy scale (HLS-14), side effects, and app adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",102.0,0.0434565,"No significant improvement was seen in anxiety, depression, or health literacy at the end of treatment between the BPSS and no-BPSS app groups.","[{'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Handa', 'Affiliation': 'Division of Drug Information Analytics, Department of Clinical Pharmacy, Showa University School of Pharmacy, Tokyo, Japan. Electronic address: shanda@pharm.showa-u.ac.jp.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Okuyama', 'Affiliation': 'Department of Breast Surgery, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Drug Information Analytics, Department of Clinical Pharmacy, Showa University School of Pharmacy, Tokyo, Japan.'}, {'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Breast Surgery, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Division of Drug Information Analytics, Department of Clinical Pharmacy, Showa University School of Pharmacy, Tokyo, Japan.'}]",Clinical breast cancer,['10.1016/j.clbc.2020.01.004']
666,31008634,Examining race as a predictor and moderator of treatment outcomes for binge-eating disorder: Analysis of aggregated randomized controlled trials.,"OBJECTIVE
To examine whether race predicted or moderated response to treatments for binge-eating disorder (BED).
METHOD
Participants were 592 adults (n = 113 Black; n = 479 White) with DSM-IV-defined BED who participated in randomized controlled trials (RCTs) at 1 medical center. Data were aggregated from RCTs for BED testing cognitive-behavioral therapy, behavioral weight loss, multimodal treatment, and/or control conditions. Participants had weight and height measured and were assessed using established interviews and self-report measures at baseline, throughout treatment, and post treatment.
RESULTS
Race did not significantly moderate treatment outcomes. Mixed models revealed a main effect of race: Black participants had fewer binge-eating episodes and lower depression than White participants across time points. Race also had a main effect in generalized estimating equations with a significantly greater proportion of Black participants achieving binge-eating remission than White participants. Race did not predict percent weight loss, but a significantly lower proportion of Black participants attained 5% weight loss than White participants. Race did not significantly predict global eating-disorder severity.
CONCLUSION
Despite disparities in treatment-seeking reported in epidemiological and RCT studies, Black individuals appear to have comparable or better treatment outcomes in BED treatment research compared with White individuals, except they were less likely to attain 5% weight loss at post treatment. This suggests that disseminating evidence-based treatments for BED among diverse populations holds promise and treatments may not require further adaptation prior to dissemination. Implementation research is needed to test treatment effectiveness across diverse providers, settings, and patient groups to improve understanding of potential predictors and moderators. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,Mixed models revealed a main effect of race: Black participants had fewer binge-eating episodes and lower depression than White participants across time points.,"['Participants were 592 adults (n = 113 Black; n = 479 White) with DSM-IV-defined BED who participated in randomized controlled trials (RCTs) at 1 medical center', 'binge-eating disorder (BED', 'binge-eating disorder']",[],"['binge-eating episodes and lower depression', 'weight loss', 'binge-eating remission', 'weight and height', 'global eating-disorder severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}]",[],"[{'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",592.0,0.0851234,Mixed models revealed a main effect of race: Black participants had fewer binge-eating episodes and lower depression than White participants across time points.,"[{'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Lydecker', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Masheb', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University.'}, {'ForeName': 'Marney A', 'Initials': 'MA', 'LastName': 'White', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000404']
667,32212335,Forty-year trends in menopausal hormone therapy use and breast cancer incidence among postmenopausal black and white women.,"After reports from the Women's Health Initiative randomized trial evaluating estrogen plus progestin, there was a sudden, substantial, and sustained decrease in all categories of menopausal hormone therapy, and the first reduction in age-adjusted breast cancer incidence in more than 20 years was seen in 2003-2004 among US women 50 years of age or older. Subsequent trends in breast cancer incidence have been described, but most reports have not focused on the postmenopausal age group or fully engaged the potential influence of reduced hormone therapy on breast cancer incidence trends by race/ethnicity. To address this gap, this commentary examines trends for annual age-adjusted breast cancer incidence over a 40-year period from 1975 to 2015 for white and black women on the basis of findings from the Surveillance, Epidemiology, and End Results 9 registries. Overall, the sharp decline in breast cancer incidence seen in 2003-2004 was followed in the subsequent decade by a continued low breast cancer incidence plateau in white women that has largely persisted. In contrast, a new discordance between breast cancer incidence trends in black and white women has emerged. In the 2005-2015 decade, a sustained increase in breast cancer incidence in black women has resulted in annual incidence rates comparable, for the first time, to those in white women. This commentary explores the hypothesis that the over-decade-long and discordant changes in breast cancer incidence rates in postmenopausal black and white women are, to a large extent, associated with changes in hormone therapy use in these 2 groups.",2020,"In the 2005-2015 decade, a sustained increase in breast cancer incidence in black women has resulted in annual incidence rates comparable, for the first time, to those in white women.","['postmenopausal black and white women', 'black and white women', 'annual age-adjusted breast cancer incidence over a 40-year period from 1975 to 2015 for white and black women']","['menopausal hormone therapy', 'estrogen plus progestin']",['breast cancer incidence'],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.0180271,"In the 2005-2015 decade, a sustained increase in breast cancer incidence in black women has resulted in annual incidence rates comparable, for the first time, to those in white women.","[{'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}]",Cancer,['10.1002/cncr.32846']
668,31278414,Validity of bladder volume measurement by ultrasound in women postpartum.,"INTRODUCTION
Vaginal birth increases the risk of urinary retention and overdistention of the bladder. To avoid unnecessary discomfort by catheterization, it is preferable to use ultrasound for diagnosis of these conditions. The aim of this study was to determine the validity of transabdominal ultrasound and a portable ultrasound system, Biocon-700, to measure bladder volume in women postpartum.
METHODS
Fifty women were included in this method comparison study. Within 48 h of giving birth, their bladder volume was measured in randomized order with both transabdominal ultrasound and Biocon-700. After urination, participants were scanned with Biocon-700 to measure residual bladder volume, and finally the bladder was emptied by catheterization. The total bladder volume was calculated as the voided volume plus the catheterized volume.
RESULTS
Biocon-700 measured 43.4 ml ± 117.4 ml (mean ± SD) lower than the total bladder volume, while volumes measured by transabdominal ultrasound were 117.8 ml ± 110.0 ml (mean ± SD) lower. Linear regression showed significant proportional bias in both methods. The Biocon-700 could detect a residual bladder volume > 150 ml with a positive predictive value of 66.7% and a negative predictive value of 100%.
CONCLUSIONS
Neither transabdominal ultrasound nor the portable ultrasound system, Biocon-700, can be used to measure bladder volume precisely after vaginal delivery. However, both ultrasound methods can be used as screening tools to prevent overdistention of the bladder, and Biocon-700 can furthermore be used to screen women for a residual bladder volume > 150 ml.",2020,"The Biocon-700 could detect a residual bladder volume > 150 ml with a positive predictive value of 66.7% and a negative predictive value of 100%.
","['Fifty women', 'women postpartum']","['transabdominal ultrasound and a portable ultrasound system, Biocon-700', 'transabdominal ultrasound and Biocon-700']",['total bladder volume'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429770', 'cui_str': 'Bladder volume (observable entity)'}]",50.0,0.0404696,"The Biocon-700 could detect a residual bladder volume > 150 ml with a positive predictive value of 66.7% and a negative predictive value of 100%.
","[{'ForeName': 'Josefine Tangen', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics and Gynecology, Herlev Hospital, Herlev and Gentofte University Hospital, Copenhagen, Denmark. j.tangenjensen@gmail.com.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Klarskov', 'Affiliation': 'Department of Obstetrics and Gynecology, Herlev Hospital, Herlev and Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jeannet', 'Initials': 'J', 'LastName': 'Lauenborg', 'Affiliation': 'Department of Obstetrics and Gynecology, Herlev Hospital, Herlev and Gentofte University Hospital, Copenhagen, Denmark.'}]",International urogynecology journal,['10.1007/s00192-019-04037-1']
669,32207048,"Effect of the ""Recruitment"" Maneuver on Respiratory Mechanics in Laparoscopic Sleeve Gastrectomy Surgery.","PURPOSE
LSG surgery is used for surgical treatment of morbid obesity. Obesity, anesthesia, and pneumoperitoneum cause reduced pulmoner functions and a tendency for atelectasis. The alveolar ""recruitment"" maneuver (RM) keeps airway pressure high, opening alveoli, and increasing arterial oxygenation. The aim of our study is to research the effect on respiratory mechanics and arterial blood gases of performing the RM in LSG surgery.
MATERIALS AND METHODS
Sixty patients undergoing LSG surgery were divided into two groups (n = 30) Patients in group R had the RM performed 5 min after desufflation with 100% oxygen, 40 cmH 2 O pressure for 40 s. Group C had standard mechanical ventilation. Assessments of respiratory mechanics and arterial blood gases were made in the 10th min after induction (T1), 10th min after insufflation (T2), 5th min after desufflation (T3), and 15th min after desufflation (T4). Arterial blood gases were assessed in the 30th min (T5) in the postoperative recovery unit.
RESULTS
In group R, values at T5, PaO 2 were significantly high, while PaCO 2 were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum. At T4, the compliance in the recruitment group was higher. In both groups, there was an increase in PIP with pneumoperitoneum and after desufflation this was identified to reduce to levels before pneumoperitoneum.
CONCLUSION
Adding the RM to PEEP administration for morbidly obese patients undergoing LSG surgery is considered to be effective in improving respiratory mechanics and arterial blood gas values and can be used safely.",2020,"In group R, values at T5, PaO 2 were significantly high, while PaCO 2 were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","['morbidly obese patients undergoing LSG surgery', 'Laparoscopic Sleeve Gastrectomy Surgery', 'Sixty patients undergoing LSG surgery']","['RM performed 5\xa0min after desufflation with 100% oxygen, 40\xa0cmH 2 O pressure for 40\xa0s. Group C had standard mechanical ventilation', 'Recruitment"" Maneuver']","['Arterial blood gases', 'respiratory mechanics and arterial blood gases', 'PIP with pneumoperitoneum', 'Respiratory Mechanics', 'respiratory mechanics and arterial blood gas values']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0255194,"In group R, values at T5, PaO 2 were significantly high, while PaCO 2 were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Sümer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. isumer@bezmialem.edu.tr.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Topuz', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Alver', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, İstanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Umutoglu', 'Affiliation': 'İstanbul Acıbadem Taksim Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mefkur', 'Initials': 'M', 'LastName': 'Bakan', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Seniyye Ülgen', 'Initials': 'SÜ', 'LastName': 'Zengin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Coşkun', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Salihoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cerrahpasa Faculty of Medicine, İstanbul University Cerrahpasa, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04551-y']
670,32207067,Malignancy Rates in Brodalumab Clinical Studies for Psoriasis.,"BACKGROUND
Brodalumab is a fully human anti-interleukin-17 receptor A monoclonal antibody efficacious for the treatment of adults with moderate-to-severe plaque psoriasis.
OBJECTIVE
This study summarizes malignancy rates in psoriasis clinical studies of brodalumab.
METHODS
Data were pooled from one phase II study and three large, multicenter, phase III randomized studies of brodalumab for the treatment of psoriasis, including two studies with randomization to brodalumab, ustekinumab, or placebo. Data from the 52-week (brodalumab and ustekinumab) and long-term (brodalumab) pools were summarized as exposure-adjusted or follow-up time-adjusted event rates per 100 patient-years (PY).
RESULTS
Exposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4). The exposure-adjusted event rate of adjudicated malignancies in the brodalumab group remained stable in the long-term analysis (0.9 [82 events]).
CONCLUSIONS
Rates of malignancy among brodalumab-treated patients with psoriasis were generally low.
TRIAL REGISTRY
ClinicalTrials.gov identifier NCT00975637; NCT01101100; NCT01708590 (AMAGINE-1); NCT01708603 (AMAGINE-2); NCT01708629 (AMAGINE-3).",2020,"RESULTS
Exposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4).","['adults with moderate-to-severe plaque psoriasis', 'Data were pooled from one phase II study and three large, multicenter, phase III randomized studies of']","['brodalumab', 'brodalumab, ustekinumab, or placebo']",['Malignancy Rates'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",,0.0899439,"RESULTS
Exposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4).","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 10 Union Square East, New York, NY, 10003, USA. alice.gottlieb@mountsinai.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 10 Union Square East, New York, NY, 10003, USA.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Bellevue Dermatology Clinic, Bellevue, WA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Israel', 'Affiliation': 'Bausch Health US, LLC, Bridgewater, NJ, USA.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': 'Ortho Dermatologics, Bridgewater, NJ, USA.'}]",American journal of clinical dermatology,['10.1007/s40257-020-00512-4']
671,32402832,Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial.,"BACKGROUND
In the present paper, we introduce our experience with the novel method during laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE).
METHODS
A prospective randomized controlled trial was performed from June 2016 to May 2019. Patients with upper rectal or sigmoid colon cancer were randomized in a 1:1 ratio to the NOSE group and the non-NOSE group. Preoperative and postoperative clinical variables were analyzed and compared between groups. Postoperative pain was analyzed utilizing a visual analog scale. Postoperative overall survival was analyzed using a Kaplan-Meier curve.
RESULTS
A total of 276 patients were enrolled, of whom 254 were randomly divided into the NOSE group (n = 122) and the conventional laparoscopic group (n = 119). NOSE failed in 22 cases, which were converted to transabdominal specimen extraction. Intention-to-treat analysis was performed, and these 22 cases were included in the NOSE group. The incidence of postoperative complications was significantly lower in the NOSE group (11/122, 9%) than in the non-NOSE group (25/119, 21%). The NOSE group had a longer operation time, less blood loss, and a lower postoperative visual analog scale score than the non-NOSE group. The time for intestinal function recovery (ventilation) and the length of hospital stay were significantly longer in the non-NOSE group. The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
CONCLUSIONS
The novel NOSE method is safe and feasible to use in patients having colorectal cancer. Compared with traditional laparoscopic surgery, the postoperative complication rates of NOSE surgery were lower with an improved short-term clinical recovery.",2020,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","['June 2016 to May 2019', 'patients having colorectal cancer', '22 cases were included in the NOSE group', 'Patients with upper rectal or sigmoid colon cancer', 'A total of 276 patients were enrolled, of whom 254']","['conventional laparoscopic group', 'traditional laparoscopic surgery', 'laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE', 'Transrectal Natural Orifice Specimen Extraction (NOSE', 'NOSE']","['incidence of postoperative complications', 'longer operation time, less blood loss', 'postoperative complication rates of NOSE surgery', 'time for intestinal function recovery (ventilation) and the length of hospital stay', 'disease-free survival rate', 'postoperative visual analog scale score', 'Postoperative overall survival', 'Postoperative pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",276.0,0.0637219,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","[{'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaijing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qixin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: fugang416@126.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.064']
672,32402931,Long-term outcome of perioperative low cardiac output syndrome in cardiac surgery: 1-year results of a multicenter randomized trial.,"PURPOSE
Perioperative myocardial dysfunction occurs frequently in cardiac surgery, and is a risk factor for morbidity and mortality. Levosimendan has been suggested to reduce mortality of patients with perioperative myocardial dysfunction. However, long-term outcome data on its efficacy in cardiac surgery are lacking.
MATERIALS AND METHODS
Cardiac surgery patients with perioperative myocardial dysfunction were randomized to levosimendan or placebo, in addition to standard inotropic care. One-year mortality data were collected.
RESULTS
We randomized 506 patients (248 to levosimendan 258 to placebo). At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60). Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass were independently associated with 1-year mortality.
CONCLUSIONS
Levosimendan administration does not improve 1-year survival in cardiac surgery patients with perioperative myocardial dysfunction. One-year mortality in these patients is 17%. Six predictive factors for long-term mortality were identified.
STUDY REGISTRATION NUMBER
NCT00994825 (ClinicalTrials.gov).",2020,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","['Cardiac surgery patients with perioperative myocardial dysfunction', 'cardiac surgery', 'cardiac surgery patients with perioperative myocardial dysfunction', '506 patients (248 to', 'patients with perioperative myocardial dysfunction']","['Levosimendan', 'perioperative low cardiac output syndrome', 'levosimendan', 'levosimendan 258 to placebo', 'levosimendan or placebo']","['Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass', '1-year survival']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0600177', 'cui_str': 'Low cardiac output syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",506.0,0.403453,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zangrillo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Vladimir V', 'Initials': 'VV', 'LastName': 'Lomivorotov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia; Novosibirsk State University, Novosibirsk, Russia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pisano', 'Affiliation': 'Division of Cardiac Anesthesia and Intensive Care Unit, AORN dei Colli - Monaldi Hospital, Naples, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Calabrò', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Brazzi', 'Affiliation': 'Department of Anesthesia, Intensive Care and Emergency, Città della Salute e della Scienza Hospital, Turin, Italy; Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Grigoryev', 'Affiliation': 'Intensive Care Unit, Scientific Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Guarracino', 'Affiliation': 'Division of Cardiothoracic Anesthesia and Intensive Care, Department of Anesthesia and Critical Care Medicine, AOU Pisana, Pisa, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Department of Anesthesia and Intensive Care, AOU Mater Domini Germaneto, Catanzaro, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crivellari', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Valery V', 'Initials': 'VV', 'LastName': 'Likhvantsev', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia; V. Negovsky Reanimatology Research Institute, Moscow, Russia.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Fominskiy', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Paternoster', 'Affiliation': 'Department of Anesthesia and Intensive Care, San Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Yavorovskiy', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Vadim V', 'Initials': 'VV', 'LastName': 'Pasyuga', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan, Russia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Oriani', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Lembo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bianchi', 'Affiliation': 'Department of Cardiovascular Anesthesia and Intensive Care, AO Ordine Mauriziano, Turin, Italy.'}, {'ForeName': 'A Mara', 'Initials': 'AM', 'LastName': 'Scandroglio', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marat N', 'Initials': 'MN', 'LastName': 'Abubakirov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Di Tomasso', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: landoni.giovanni@hsr.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.04.005']
673,32402953,The effect of swimming program on body composition levels in adolescents with Down syndrome.,"BACKGROUND
Down syndrome has been associated with more than 80 clinical characteristics such as diabetes, cardiovascular problems or obesity.
AIMS
The current study determined the effect of a 36 weeks swimming program on different indicators of body composition in adolescents with Down syndrome.
METHODS AND PROCEDURES OUTCOMES
45 adolescents with Down syndrome were recruited and randomized to two groups (control group vs. exercise group). Adolescents allocated in the control group carried out a recreational swimming program twice a week during 36 weeks meanwhile adolescents allocated in the exercise group did exercise three time a week during 36 weeks. BMI, Waist circumference, waist-to-height ratio, triceps, subscapular, suprailiac and thigh skinfold were measured.
RESULTS
ANCOVA tests were used to evaluate differences between groups in post-test intervention. Repeated measures of ANOVA were performed in order to assess differences in pre-test intervention in each group. t test were carried out to compare the pre-post-intervention differences in physical characteristics and body composition within each group. The exercise group had significant improvements in all variables of body composition (p < 0.05) except in subscapular and thigh skinfold.
CONCLUSIONS AND IMPLICATIONS
The results suggest that a 36 weeks swimming program consisting of 3 sessions of 50 minutes is able to decrease levels of body composition in a sample of adolescents with Down syndrome. The findings indicate that it would be important to generate high intensity sports programs in sports associations in order to obtain positive impact on body composition levels within this population.",2020,"The exercise group had significant improvements in all variables of body composition (p < 0.05) except in subscapular and thigh skinfold.
","['45 adolescents with Down syndrome', 'adolescents with Down syndrome']","['swimming program', 'recreational swimming program']","['body composition levels', 'body composition', 'levels of body composition', 'BMI, Waist circumference, waist-to-height ratio, triceps, subscapular, suprailiac and thigh skinfold', 'subscapular and thigh skinfold']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}]",45.0,0.0627267,"The exercise group had significant improvements in all variables of body composition (p < 0.05) except in subscapular and thigh skinfold.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Suarez-Villadat', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Alfonso X el Sabio University, Madrid, Spain. Electronic address: bsuarvil@uax.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Luna-Oliva', 'Affiliation': 'Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine. Rey Juan Carlos University, Madrid, Spain. Electronic address: laura.luna@urjc.es.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Acebes', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain. Electronic address: carla.acebes@estudiante.uam.es.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Villagra', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain. Electronic address: Ariel.villagra@uam.es.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103643']
674,32405757,Attention-enhancing effects of propranolol and synergistic effects with nicotine.,"Nicotine increases the output of every major neurotransmitter. In previous studies designed to identify the secondary neurotransmitter systems mediating nicotine's attention-enhancing effects in a rat model, the β-adrenoceptor antagonist propranolol blocked these effects. The present study was designed to test whether this mechanism held true in humans, thus guiding development of novel nicotinic agonists for cognitive enhancement. Twenty-six nonsmokers completed a nicotine (7 mg/24 h transdermally) x propranolol (40 mg p.o., body weight-adjusted) interaction study. Over four test days, each participant received double-placebo, nicotine only, propranolol only, and nicotine plus propranolol in randomized sequence before cognitive testing. No drug effects were seen in a visuospatial attention task. In the Rapid Visual Information Processing Task, performed in two 15-min blocks, neither drug alone significantly affected hit rate, but both drugs combined acted synergistically to alleviate its decrement over time in the first block and displayed additive beneficial effects in the second. In a change detection task, propranolol enhanced accuracy and reduced reaction time independent of nicotine presence. Propranolol also enhanced subjective self-reports of vigor. Overall, the findings were contrary to those hypothesized. Propranolol displayed beneficial effects on cognition, especially on sustaining performance over time. β-adrenoceptor activation by nicotine-induced noradrenaline release appeared to limit performance-enhancing effects of nicotine, because they were unmasked by β-adrenoceptor antagonism. The results suggest that cognitive effects of changes in β-adrenoceptor tone are context-dependent; contrary to rodent paradigms, human cognitive paradigms require no physical orienting in space but prolonged periods of remaining stationary while sustaining predictable processing demands.",2020,"In the Rapid Visual Information Processing Task, performed in two 15-min blocks, neither drug alone significantly affected hit rate, but both drugs combined acted synergistically to alleviate its decrement over time in the first block and displayed additive beneficial effects in the second.",['Twenty-six nonsmokers completed a nicotine (7 mg/24 h transdermally'],"['double-placebo, nicotine only, propranolol only, and nicotine plus propranolol', 'nicotine', 'Nicotine', 'Propranolol', 'propranolol']","['visuospatial attention task', 'output of every major neurotransmitter']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}]",,0.0267626,"In the Rapid Visual Information Processing Task, performed in two 15-min blocks, neither drug alone significantly affected hit rate, but both drugs combined acted synergistically to alleviate its decrement over time in the first block and displayed additive beneficial effects in the second.","[{'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA. bhahn@som.umaryland.edu.'}, {'ForeName': 'Cory K', 'Initials': 'CK', 'LastName': 'Olmstead', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Marie B', 'Initials': 'MB', 'LastName': 'Yuille', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Chiappelli', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Ashleigh K', 'Initials': 'AK', 'LastName': 'Wells', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00794-5']
675,31410598,Exploratory analyses of the Danish Palliative Care Trial (DanPaCT): a randomized trial of early specialized palliative care plus standard care versus standard care in advanced cancer patients.,"BACKGROUND
Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials.
OBJECTIVE
To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT).
METHODS
We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve.
RESULTS
In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05).
CONCLUSION
In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group.
TRIAL REGISTRATION
NCT01348048.",2020,"Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05).
CONCLUSION
In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems.","['Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of', 'advanced cancer patients', '145 patients were randomized to early']","['specialized palliative care plus standard care versus 152 to standard care only', 'specialized palliative care plus standard care versus standard care', 'early specialized palliative care plus standard care versus standard care']","['symptoms or problems', 'Cancer Quality of Life Questionnaire (EORTC QLQ-C30', 'satisfied with the health care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]",145.0,0.135597,"Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05).
CONCLUSION
In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems.","[{'ForeName': 'Anna Thit', 'Initials': 'AT', 'LastName': 'Johnsen', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark. atjohnsen@health.sdu.dk.'}, {'ForeName': 'Morten Aagaard', 'Initials': 'MA', 'LastName': 'Petersen', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sjøgren', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Pedersen', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mette Asbjoern', 'Initials': 'MA', 'LastName': 'Neergaard', 'Affiliation': 'Palliative Care Team, Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Damkier', 'Affiliation': 'Palliative Team Fyn, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fayers', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen Medical School, Aberdeen, Scotland, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lindschou', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Annette S', 'Initials': 'AS', 'LastName': 'Strömgren', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jan Bjoern', 'Initials': 'JB', 'LastName': 'Nielsen', 'Affiliation': 'Palliative Team Herning, Herning Hospital, Herning, Denmark.'}, {'ForeName': 'Irene J', 'Initials': 'IJ', 'LastName': 'Higginson', 'Affiliation': ""King's College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, London, UK.""}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Groenvold', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05021-7']
676,32205449,"Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial.","BACKGROUND
The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery. The effect of HIPEC remains undetermined in patients who are candidates for primary cytoreductive surgery.
PRIMARY OBJECTIVE
The primary objective is to evaluate the effect of HIPEC on overall survival in patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm in maximum dimension.
STUDY HYPOTHESIS
We hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer.
TRIAL DESIGN
This international, randomized, open-label, phase III trial will enroll 538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer. Following complete or near-complete (residual disease ≤2.5 mm) primary cytoreduction, patients are randomly allocated (1:1) to receive HIPEC or no HIPEC. All patients will receive six courses of platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab according to current guidelines.
MAJOR ELIGIBILITY CRITERIA
Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery. Patients with resectable umbilical, spleen, or local bowel lesions may be included. Enlarged extra-abdominal lymph nodes should be negative on FDG-PET or fine-needle aspiration/biopsy.
PRIMARY ENDPOINT
The primary endpoint is overall survival.
SAMPLE SIZE
To detect a HR of 0.67 in favor of HIPEC, 200 overall survival events are required. With an expected accrual period of 60 months and 12 months additional follow-up, 538 patients need to be randomized.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
The OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026.
TRIAL REGISTRATION
ClinicalTrials.gov:NCT03772028.",2020,"BACKGROUND
The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery.","['patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5\u2009mm in maximum dimension', 'Patients with resectable umbilical, spleen, or local bowel lesions', 'FIGO stage III epithelial ovarian cancer', '538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer', 'Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery', 'patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery', '538 patients need to be randomized', 'patients who are candidates for primary cytoreductive surgery', 'patients with primary FIGO stage III epithelial ovarian cancer']","['Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC', 'platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab', 'hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery', 'HIPEC', 'HIPEC or no HIPEC']","['recurrence-free and overall survival', 'overall survival', 'overall survival events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1882413', 'cui_str': 'PARP Inhibitors'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",538.0,0.335434,"BACKGROUND
The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Koole', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'van Stein', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Department of Biostatistics, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Barton', 'Affiliation': 'Department of Gynaecological Oncology, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Perrin', 'Affiliation': 'Queensland Centre for Gynaecological Cancer, Herston, Queensland, Australia.'}, {'ForeName': 'Donal', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'Gynaecology Oncology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Department of Gynecologic Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Berit Jul', 'Initials': 'BJ', 'LastName': 'Mosgaard', 'Affiliation': 'Department of Gynaecology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': 'Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Pierre-Emmanuel', 'Initials': 'PE', 'LastName': 'Colombo', 'Affiliation': 'Department of Surgical Oncology, Institut régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'W J van', 'Initials': 'WJV', 'LastName': 'Driel', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands w.v.driel@nki.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001231']
677,32200994,High-flow nasal-oxygenation-assisted fibreoptic tracheal intubation in critically ill patients with COVID-19 pneumonia: a prospective randomised controlled trial.,,2020,,['critically ill patients with COVID-19 pneumonia'],['High-flow nasal-oxygenation-assisted fibreoptic tracheal intubation'],[],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'TS-COV19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",[],,0.33431,,"[{'ForeName': 'Cai-Neng', 'Initials': 'CN', 'LastName': 'Wu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Lin-Zhi', 'Initials': 'LZ', 'LastName': 'Xia', 'Affiliation': 'Wuhan, China.'}, {'ForeName': 'Kun-Hong', 'Initials': 'KH', 'LastName': 'Li', 'Affiliation': 'Wuhan, China.'}, {'ForeName': 'Wu-Hua', 'Initials': 'WH', 'LastName': 'Ma', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Dong-Nan', 'Initials': 'DN', 'LastName': 'Yu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'Guangzhou, China.'}, {'ForeName': 'Bi-Xi', 'Initials': 'BX', 'LastName': 'Li', 'Affiliation': 'Wuhan, China. Electronic address: bxlee@sohu.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Guangzhou, China. Electronic address: yingcao1986@163.com.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.02.020']
678,29741487,Regular drug-eluting stents versus dedicated bifurcation drug-eluting BiOSS stents for coronary bifurcation treatment: four-year results of the randomised POLBOS I and POLBOS II clinical trials.,,2020,"At 48-month there were no statistical differences in terms of MACE (rDES vs BiOSS: 18.8%vs19.8%,p=0.64), TLR (12.1%vs15.3%,p=0.34), MI (4.5%vs2.1%,p=0.72) or cardiac death (2.2%vs1.8%,p=0.81) between rDES and BiOSS groups.","['445 patients with 222 patients in BiOSS group and 223 patients in rDES group were analyzed', 'patients with stable CAD or NSTE-ACS']","['MACE', 'rDES', 'Regular drug-eluting stents versus dedicated bifurcation drug-eluting BiOSS® stents', 'regular DES (rDES']","['MI (4.5%vs2.1%,p=0.72) or cardiac death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}]","[{'cui': 'C0376297', 'cui_str': 'Cardiac Death'}]",445.0,0.0244033,"At 48-month there were no statistical differences in terms of MACE (rDES vs BiOSS: 18.8%vs19.8%,p=0.64), TLR (12.1%vs15.3%,p=0.34), MI (4.5%vs2.1%,p=0.72) or cardiac death (2.2%vs1.8%,p=0.81) between rDES and BiOSS groups.","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gil', 'Affiliation': 'Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Bil', 'Affiliation': ''}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kern', 'Affiliation': ''}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Ingio Garcia', 'Affiliation': ''}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Formuszewicz', 'Affiliation': ''}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Dobrzycki', 'Affiliation': ''}, {'ForeName': 'Dobrin', 'Initials': 'D', 'LastName': 'Vassilev', 'Affiliation': ''}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Segiet', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-18-00172']
679,28965138,Enhancing an oncologist's recommendation to exercise to manage fatigue levels in breast cancer patients: a randomized controlled trial.,"PURPOSE
Fatigue is a troublesome symptom for breast cancer patients, which might be mitigated with exercise. Cancer patients often prefer their oncologist recommend an exercise program, yet a recommendation alone may not be enough to change behavior. Our study determined whether adding an exercise DVD to an oncologist's recommendation to exercise led to better outcomes than a recommendation alone.
METHODS
Ninety breast cancer patients, at varying phases of treatment and stages of disease, were randomized to receive the following: an oncologist verbal recommendation to exercise (REC; n = 43) or REC plus a cancer-specific yoga DVD (REC + DVD; n = 47). Fatigue, vigor, and depression subscales of the Profile of Mood States, and physical activity levels (MET-min/week), exercise readiness, and self-efficacy were assessed at baseline, 4, and 8 weeks. Analyses controlled for age, time since diagnosis, and metastatic disease.
RESULTS
Over 8 weeks, women in REC + DVD used the DVD an average of twice per week. The REC + DVD group had greater reductions in fatigue (- 1.9 ± 5.0 vs. - 1.0 ± 3.5, p = 0.02), maintained exercise readiness (- 0.1 ± 1.1 vs. - 0.3 ± 1.3; p = 0.03), and reported less of a decrease in physical activity (- 420 ± 3075 vs. - 427 ± 5060 MET-min/week, p = 0.06) compared to REC only.
CONCLUSIONS
A low-cost, easily distributed, and scalable yoga-based DVD could be a simple booster to an oncologist's advice that motivates breast cancer patients, even those with advanced disease and/or in treatment, to engage in self-care, e.g., exercise, to manage fatigue.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03120819.",2018,"The REC + DVD group had greater reductions in fatigue (- 1.9 ± 5.0 vs. - 1.0 ± 3.5, p = 0.02), maintained exercise readiness (- 0.1 ± 1.1 vs. - 0.3 ± 1.3; p = 0.03), and reported less of a decrease in physical activity (- 420 ± 3075 vs. - 427 ± ","['Ninety breast cancer patients, at varying phases of treatment and stages of disease', 'breast cancer patients', 'Cancer patients', 'motivates breast cancer patients']",['oncologist verbal recommendation to exercise (REC; n\xa0=\xa043) or REC plus a cancer-specific yoga DVD (REC + DVD; n\xa0=\xa047'],"['fatigue', 'physical activity', 'Fatigue, vigor, and depression subscales of the Profile of Mood States, and physical activity levels (MET-min/week), exercise readiness, and self-efficacy', 'maintained exercise readiness']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449385', 'cui_str': 'Staging of disease (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0418878', 'cui_str': 'Advice to exercise'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",90.0,0.0783117,"The REC + DVD group had greater reductions in fatigue (- 1.9 ± 5.0 vs. - 1.0 ± 3.5, p = 0.02), maintained exercise readiness (- 0.1 ± 1.1 vs. - 0.3 ± 1.3; p = 0.03), and reported less of a decrease in physical activity (- 420 ± 3075 vs. - 427 ± ","[{'ForeName': 'Kerri M', 'Initials': 'KM', 'LastName': 'Winters-Stone', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA. wintersk@ohsu.edu.'}, {'ForeName': 'Esther L', 'Initials': 'EL', 'LastName': 'Moe', 'Affiliation': 'Department of Sports Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Cynthia K', 'Initials': 'CK', 'LastName': 'Perry', 'Affiliation': ""School of Nursing, Oregon Health & Science University, Mailcode: SN-ORD, 3455 SW US Veteran's Hospital Road, Portland, OR, 97239, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Medysky', 'Affiliation': ""School of Nursing, Oregon Health & Science University, Mailcode: SN-ORD, 3455 SW US Veteran's Hospital Road, Portland, OR, 97239, USA.""}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Pommier', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vetto', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Arpana', 'Initials': 'A', 'LastName': 'Naik', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-017-3909-z']
680,32186940,Intravitreal Conbercept Injection as an Adjuvant in Vitrectomy with Silicone Oil Infusion for Severe Proliferative Diabetic Retinopathy.,"Purpose: To assess the clinical effects of preoperative, intraoperative, or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in vitrectomy with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods: Ninety-eight eyes of 98 severe PDR patients undergoing vitrectomy with silicone oil tamponade were randomly assigned to 3 groups: Group 1 (34 eyes) received IVC injections 3 to 5 days before surgery; Group 2 (35 eyes) received IVC injections at the end of surgery; and Group 3 (29 eyes) received IVC injections 3 to 5 days before and at the end of operation. Follow-up examinations were performed for 6 months. Results: The incidence and severity of intraoperative bleeding were not significantly different ( P = 0.233). However, the duration of surgery was significantly shorter in Group 1 and Group 3 compared with Group 2 ( P < 0.001). The incidences of early and late recurrent vitreous hemorrhage (VH) were 32.35%, 28.57%, and 13.80%, respectively. At 6-month follow-up, mean best-corrected visual acuity had significantly increased to 1.25 ± 0.45 logMAR in Group 1, 1.29 ± 0.46 logMAR in Group 2, 1.16 ± 0.44 logMAR in Group 3 (all P < 0.001). The incidence of postoperative VH, neovascular glaucoma, and retinal detachment in Group 3 was slightly lower, however, no significant differences were observed (all P > 0.05). In young patients, similar results were observed and Group 3 had better visual improvements ( P = 0.037). Conclusions: Preoperative IVC injection could be a safe and effective adjunct in pars plana vitrectomy with silicone oil tamponade for severe PDR. Preoperative combined with intraoperative IVC are promising, especially in young patients.",2020,"In young patients, similar results were observed and Group 3 had better visual improvements ( P = 0.037). ","['young patients', 'severe proliferative diabetic retinopathy (PDR', 'Ninety-eight eyes of 98 severe PDR patients undergoing', 'Severe Proliferative Diabetic Retinopathy']","['vitrectomy with silicone oil tamponade', 'Intravitreal Conbercept Injection', 'preoperative, intraoperative, or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in vitrectomy with silicone oil tamponade', 'Preoperative combined with intraoperative IVC', 'IVC injections', 'Silicone Oil Infusion']","['mean best-corrected visual acuity', 'visual improvements', 'incidence of postoperative VH, neovascular glaucoma, and retinal detachment', 'incidence and severity of intraoperative bleeding', 'incidences of early and late recurrent vitreous hemorrhage (VH', 'duration of surgery']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0037111', 'cui_str': 'Silicone Oils'}, {'cui': 'C0579016', 'cui_str': 'Tamponade - action (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0017609', 'cui_str': 'Glaucoma, Neovascular'}, {'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",98.0,0.029451,"In young patients, similar results were observed and Group 3 had better visual improvements ( P = 0.037). ","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhongjing', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yanwei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jili', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Shibei Hospital of Jingan District, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0149']
681,32043763,"Health-Related Quality of Life in MONARCH 2: Abemaciclib plus Fulvestrant in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy.","BACKGROUND
In the phase III MONARCH 2 study (NCT02107703), abemaciclib plus fulvestrant significantly improved progression-free survival (PFS) versus placebo plus fulvestrant in patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer (ABC). This study assessed patient-reported pain, global health-related quality of life (HRQoL), functioning, and symptoms.
MATERIALS AND METHODS
Abemaciclib or placebo (150 p.o. mg twice daily) plus fulvestrant (500 mg, per label) were randomly assigned (2:1). The modified Brief Pain Inventory, Short Form (mBPI-sf); European Organization for Research and Treatment of Cancer (EORTC) QoL Core 30 (QLQ-C30); and Breast Cancer Questionnaire (QLQ-BR23) assessed outcomes. Data were collected at baseline, cycle 2, every two cycles 3-13, thereafter at every three cycles, and 30 days postdiscontinuation. Longitudinal mixed regression and Cox proportional hazards models assessed postbaseline change and time to sustained deterioration (TTSD) by study arm.
RESULTS
On-treatment HRQoL scores were consistently maintained from baseline and similar between arms. Patients in the abemaciclib arm (n = 446) experienced a 4.9-month delay in pain deterioration (mBPI-sf), compared with the control arm (n = 223), and significantly greater TTSD on the mBPI-sf and analgesic use (hazard ratio, 0.76; 95% CI, 0.59-0.98) and QLQ-C30 pain item (hazard ratio, 0.62; 95% CI, 0.48-0.79). TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning. Only diarrhea significantly favored the control arm (hazard ratio, 1.60; 95% CI, 1.20-2.10).
CONCLUSION
HRQoL was maintained on abemaciclib plus fulvestrant. Alongside superior PFS and manageable safety profile, results support treatment with abemaciclib plus fulvestrant in a population of patients with endocrine-resistant HR+, HER2-negative ABC.
IMPLICATIONS FOR PRACTICE
In MONARCH 2, abemaciclib plus fulvestrant demonstrated superior efficacy and a manageable safety profile for patients with in hormone receptor-positive (HR+), HER2-negative (-) advanced breast cancer (ABC). Impact on health-related quality of life (HRQoL) is important to consider, given the palliative nature of ABC treatment. In this study, abemaciclib plus fulvestrant, compared with placebo plus fulvestrant, significantly delayed sustained deterioration of pain and other patient-reported symptoms (including fatigue, nausea, vomiting), and social and cognitive functioning. Combined with demonstrated clinical benefit and tolerability, the stabilization of patient-reported symptoms and HRQoL further supports abemaciclib plus fulvestrant as a desirable treatment option in endocrine resistant, HR+, HER2- ABC.",2020,"TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning.","['patients with endocrine-resistant HR+, HER2-negative ABC', 'patients with in hormone receptor-positive (HR+), HER2-negative (-) advanced breast cancer (ABC', 'patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer (ABC', 'Cancer (EORTC', 'Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer']","['fulvestrant', 'TTSD', 'placebo', 'placebo plus fulvestrant', 'abemaciclib plus fulvestrant', 'Fulvestrant']","['HRQoL scores', 'diarrhea', '4.9-month delay in pain deterioration (mBPI-sf', 'pain, global health-related quality of life (HRQoL), functioning, and symptoms', 'HRQoL', 'progression-free survival (PFS', 'fatigue, nausea and vomiting, and cognitive and social functioning', 'QoL Core 30 (QLQ-C30); and Breast Cancer Questionnaire (QLQ-BR23', 'delayed sustained deterioration of pain and other patient-reported symptoms (including fatigue, nausea, vomiting), and social and cognitive functioning', 'QLQ-C30 pain item', 'health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.172778,"TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning.","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kaufman', 'Affiliation': 'University of Vermont Cancer Center, University of Vermont Medical Center, Burlington, Vermont, USA.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Seoul, Republic of Korea.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': ""Department of Women's Health, University Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Andre', 'Affiliation': 'Eli Lilly and Company, Paris, France.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Stoffregen', 'Affiliation': 'Eli Lilly and Company, Bad Homburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Shekarriz', 'Affiliation': 'Eli Lilly and Company, Bad Homburg, Germany.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Price', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gebra Cuyun', 'Initials': 'GC', 'LastName': 'Carter', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0551']
682,32186326,Long-term dietary intervention reveals resilience of the gut microbiota despite changes in diet and weight.,"BACKGROUND
With the rising rates of obesity and associated metabolic disorders, there is a growing need for effective long-term weight-loss strategies, coupled with an understanding of how they interface with human physiology. Interest is growing in the potential role of gut microbes as they pertain to responses to different weight-loss diets; however, the ways that diet, the gut microbiota, and long-term weight loss influence one another is not well understood.
OBJECTIVES
Our primary objective was to determine if baseline microbiota composition or diversity was associated with weight-loss success. A secondary objective was to track the longitudinal associations of changes to lower-carbohydrate or lower-fat diets and concomitant weight loss with the composition and diversity of the gut microbiota.
METHODS
We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet.
RESULTS
While baseline microbiota composition was not predictive of weight loss, each diet resulted in substantial changes in the microbiota 3-mo after the start of the intervention; some of these changes were diet specific (14 taxonomic changes specific to the healthy low-carbohydrate diet, 12 taxonomic changes specific to the healthy low-fat diet) and others tracked with weight loss (7 taxonomic changes in both diets). After these initial shifts, the microbiota returned near its original baseline state for the remainder of the intervention, despite participants maintaining their diet and weight loss for the entire study.
CONCLUSIONS
These results suggest a resilience to perturbation of the microbiota's starting profile. When considering the established contribution of obesity-associated microbiotas to weight gain in animal models, microbiota resilience may need to be overcome for long-term alterations to human physiology. This trial was registered at clinicaltrials.gov as NCT01826591.",2020,"We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet.
",['49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet'],[],['weight loss'],"[{'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",49.0,0.0217248,"We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet.
","[{'ForeName': 'Gabriela K', 'Initials': 'GK', 'LastName': 'Fragiadakis', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Wastyk', 'Affiliation': 'Department of Bioengineering, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Robinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford School of Medicine, Stanford, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa046']
683,32178568,Influence of Sevoflurane-Based Anesthesia versus Total Intravenous Anesthesia on Intraoperative Neuromonitoring during Thyroidectomy.,"OBJECTIVE
To examine the influence of sevoflurane-based combined intravenous and inhaled anesthesia versus propofol-based total intravenous anesthesia (TIVA) on intraoperative neuromonitoring (IONM) during thyroidectomy.
STUDY DESIGN
A randomized controlled trial.
SETTING
The present study was conducted in a tertiary hospital.
SUBJECTS AND METHODS
Forty patients were randomly assigned to a sevoflurane-based combined intravenous and inhalation group (group S) or a propofol-based total intravenous group (group P). Anesthesia was induced with midazolam, sufentanil, propofol, and cisatracurium in both groups and was maintained with sevoflurane and remifentanil in group S and with TIVA with propofol and remifentanil in group P. IONM was performed intermittently according to the IONM formula standard.
RESULTS
The time until detection of the first positive electromyographic (EMG) signal was significantly longer in group S (median, 41.0 minutes [interquartile range, 37.5-49.3]) than in group P (37.0 minutes [33.3-41.5], P = .028). All patients in group P had a positive EMG signal at initial monitoring, whereas 8 patients (40.0%) in group S did not. The rate of positive EMG signal at initial monitoring was significantly higher in group P than in group S ( P = .006). The amplitude of the evoked potentials at V1, R1, R2, and V2 were similar between the groups.
CONCLUSION
Combined intravenous and inhaled anesthesia based on sevoflurane-remifentanil prolonged the time until detection of a positive EMG signal during IONM as compared with TIVA with propofol-remifentanil in patients undergoing thyroidectomy.",2020,The rate of positive EMG signal at initial monitoring was significantly higher in group P than in group S ( P = .006).,"['The present study was conducted in a tertiary hospital', 'patients undergoing thyroidectomy', 'Forty patients']","['Sevoflurane-Based Anesthesia versus Total Intravenous Anesthesia', 'propofol-remifentanil', 'TIVA with propofol and remifentanil', 'sevoflurane-remifentanil', 'sevoflurane and remifentanil', 'sevoflurane-based combined intravenous and inhalation group', 'propofol-based total intravenous group', 'sevoflurane-based combined intravenous and inhaled anesthesia versus propofol-based total intravenous anesthesia (TIVA', 'midazolam, sufentanil, propofol, and cisatracurium']","['time until detection of the first positive electromyographic (EMG) signal', 'intraoperative neuromonitoring (IONM', 'rate of positive EMG signal at initial monitoring', 'time until detection of a positive EMG signal', 'positive EMG signal']","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",40.0,0.03895,The rate of positive EMG signal at initial monitoring was significantly higher in group P than in group S ( P = .006).,"[{'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Head and Neck Surgery, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jiaonan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820912030']
684,31504461,Causal association between periodontitis and hypertension: evidence from Mendelian randomization and a randomized controlled trial of non-surgical periodontal therapy.,"AIMS
Inflammation is an important driver of hypertension. Periodontitis is a chronic inflammatory disease, which could provide a mechanism for pro-hypertensive immune activation, but evidence of a causal relationship in humans is scarce. We aimed to investigate the nature of the association between periodontitis and hypertension.
METHODS AND RESULTS
We performed a two-sample Mendelian randomization analysis in the ∼750 000 UK-Biobank/International Consortium of Blood Pressure-Genome-Wide Association Studies participants using single nucleotide polymorphisms (SNPs) in SIGLEC5, DEFA1A3, MTND1P5, and LOC107984137 loci GWAS-linked to periodontitis, to ascertain their effect on blood pressure (BP) estimates. This demonstrated a significant relationship between periodontitis-linked SNPs and BP phenotypes. We then performed a randomized intervention trial on the effects of treatment of periodontitis on BP. One hundred and one hypertensive patients with moderate/severe periodontitis were randomized to intensive periodontal treatment (IPT; sub- and supragingival scaling/chlorhexidine; n = 50) or control periodontal treatment (CPT; supragingival scaling; n = 51) with mean ambulatory 24-h (ABPM) systolic BP (SBP) as primary outcome. Intensive periodontal treatment improved periodontal status at 2 months, compared to CPT. This was accompanied by a substantial reduction in mean SBP in IPT compared to the CPT (mean difference of -11.1 mmHg; 95% CI 6.5-15.8; P < 0.001). Systolic BP reduction was correlated to periodontal status improvement. Diastolic BP and endothelial function (flow-mediated dilatation) were also improved by IPT. These cardiovascular changes were accompanied by reductions in circulating IFN-γ and IL-6 as well as activated (CD38+) and immunosenescent (CD57+CD28null) CD8+T cells, previously implicated in hypertension.
CONCLUSION
A causal relationship between periodontitis and BP was observed providing proof of concept for development of clinical trial in a large cohort of hypertensive patients. ClinicalTrials.gov: NCT02131922.",2019,"These cardiovascular changes were accompanied by reductions in circulating IFN-γ and IL-6 as well as activated (CD38+) and immunosenescent (CD57+CD28null) CD8+T cells, previously implicated in hypertension.
","['One hundred and one hypertensive patients with moderate/severe periodontitis', 'hypertensive patients', 'two-sample Mendelian randomization analysis in the ∼750\xa0000']",['intensive periodontal treatment (IPT; sub- and supragingival scaling/chlorhexidine; n\u2009=\u200950) or control periodontal treatment (CPT; supragingival scaling; n\u2009=\u200951) with mean ambulatory 24-h (ABPM) systolic BP (SBP'],"['Diastolic BP and endothelial function (flow-mediated dilatation', 'periodontal status', 'Systolic BP reduction', 'circulating IFN-γ and IL-6 as well as activated (CD38+) and immunosenescent (CD57+CD28null) CD8+T cells', 'blood pressure (BP) estimates']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C2718019', 'cui_str': 'Mendelian Randomization Analysis'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0845079,"These cardiovascular changes were accompanied by reductions in circulating IFN-γ and IL-6 as well as activated (CD38+) and immunosenescent (CD57+CD28null) CD8+T cells, previously implicated in hypertension.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Czesnikiewicz-Guzik', 'Affiliation': 'Department of Periodontology and Oral Sciences Research Group, University of Glasgow Dental School, Glasgow, UK.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Osmenda', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Siedlinski', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Nosalski', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Pelka', 'Affiliation': 'Department of Dental Prophylaxis and Experimental Dentistry, Jagiellonian University Medical College, Krakow, 31-107 Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nowakowski', 'Affiliation': 'Department of Dental Prophylaxis and Experimental Dentistry, Jagiellonian University Medical College, Krakow, 31-107 Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Wilk', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Tomasz P', 'Initials': 'TP', 'LastName': 'Mikolajczyk', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Schramm-Luc', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Furtak', 'Affiliation': 'Department of Dental Prophylaxis and Experimental Dentistry, Jagiellonian University Medical College, Krakow, 31-107 Poland.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Matusik', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Koziol', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Drozdz', 'Affiliation': ""St. Anna's Hospital, 32-200 Miechow, Poland.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Munoz-Aguilera', 'Affiliation': 'Periodontology Unit, UCL Eastman Dental Institute, London, UK.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Tomaszewski', 'Affiliation': 'Division of Cardiovascular Sciences, School of Medical Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Evangelou', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Caulfield', 'Affiliation': 'William Harvey Research Institute, NIHR Biomedical Research Centre at Barts, Queen Mary University of London, London, UK.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Grodzicki', 'Affiliation': 'Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, 31-107 Krakow, Poland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Aiuto"", 'Affiliation': 'Periodontology Unit, UCL Eastman Dental Institute, London, UK.'}, {'ForeName': 'Tomasz J', 'Initials': 'TJ', 'LastName': 'Guzik', 'Affiliation': 'Department of Internal and Agricultural Medicine, Jagiellonian University Medical College, 31-107, Krakow, Poland.'}]",European heart journal,['10.1093/eurheartj/ehz646']
685,31749028,"Impact of a Low-Intensity Resource Referral Intervention on Patients' Knowledge, Beliefs, and Use of Community Resources: Results from the CommunityRx Trial.","BACKGROUND
Connecting patients to community-based resources is now a cornerstone of modern healthcare that supports self-management of health. The mechanisms that link resource information to behavior change, however, remain poorly understood.
OBJECTIVE
To evaluate the impact of CommunityRx, an automated, low-intensity resource referral intervention, on patients' knowledge, beliefs, and use of community resources.
DESIGN
Real-world controlled clinical trial at an urban academic medical center in 2015-2016; participants were assigned by alternating week to receive the CommunityRx intervention or usual care. Surveys were administered at baseline, 1 week, 1 month, and 3 months.
PARTICIPANTS
Publicly insured adults, ages 45-74 years.
INTERVENTION
CommunityRx generated an automated, personalized list of resources, known as HealtheRx, near each participant's home using condition-specific, evidence-based algorithms. Algorithms used patient demographic and health characteristics documented in the electronic health record to identify relevant resources from a comprehensive, regularly updated database of health-related resources in the study area.
MAIN MEASURES
Using intent-to-treat analysis, we examined the impact of HealtheRx referrals on (1) knowledge of the most commonly referred resource types, including healthy eating classes, individual counseling, mortgage assistance, smoking cessation, stress management, and weight loss classes or groups, and (2) beliefs about having resources in the community to manage health.
KEY RESULTS
In a real-world controlled trial of 374 adults, intervention recipients improved knowledge (AOR = 2.15; 95% CI, 1.29-3.58) and beliefs (AOR = 1.68; 95% CI, 1.07-2.64) about common resources in the community to manage health, specifically gaining knowledge about smoking cessation (AOR = 2.76; 95% CI, 1.07-7.12) and weight loss resources (AOR = 2.26; 95% CI 1.05-4.84). Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02).
CONCLUSIONS
In a middle-age and older population with high morbidity, a low-intensity health IT intervention to deliver resource referrals promoted behavior change by increasing knowledge and positive beliefs about community resources for self-management of health.
NIH TRIAL REGISTRY
NCT02435511.",2020,"Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02).
","['urban academic medical center in 2015-2016; participants', 'Publicly insured adults, ages 45-74\xa0years', 'healthy eating classes, individual counseling, mortgage assistance, smoking cessation, stress management, and weight loss classes or groups, and (2)\xa0beliefs about having resources in the community to manage health', '374 adults']","['Low-Intensity Resource Referral Intervention', 'CommunityRx intervention or usual care']","['knowledge', 'weight loss resources']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",374.0,0.0757793,"Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02).
","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Tung', 'Affiliation': 'Section of General Internal Medicine, University of Chicago, Chicago, IL, USA. eliztung@uchicago.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Abramsohn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Boyd', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Makelarski', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Beiser', 'Affiliation': 'Section of Emergency Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Chiahung', 'Initials': 'C', 'LastName': 'Chou', 'Affiliation': 'Department of Health Outcomes Research and Policy, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Elbert S', 'Initials': 'ES', 'LastName': 'Huang', 'Affiliation': 'Section of General Internal Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ozik', 'Affiliation': 'Consortium for Advanced Science and Engineering, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Chaitanya', 'Initials': 'C', 'LastName': 'Kaligotla', 'Affiliation': 'Consortium for Advanced Science and Engineering, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Stacy Tessler', 'Initials': 'ST', 'LastName': 'Lindau', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05530-5']
686,32401221,A Mobile Health App for the Collection of Functional Outcomes After Inpatient Stroke Rehabilitation: Pilot Randomized Controlled Trial.,"BACKGROUND
Monitoring the functional status of poststroke patients after they transition home is significant for rehabilitation. Mobile health (mHealth) technologies may provide an opportunity to reach and follow patients post discharge. However, the feasibility and validity of functional assessments administered by mHealth technologies are unknown.
OBJECTIVE
This study aimed to evaluate the feasibility, validity, and reliability of functional assessments administered through the videoconference function of a mobile phone-based app compared with administration through the telephone function in poststroke patients after rehabilitation hospitalization.
METHODS
A randomized controlled trial was conducted in a rehabilitation hospital in Southeast China. Participants were randomly assigned to either a videoconference follow-up (n=60) or a telephone follow-up (n=60) group. We measured the functional status of participants in each group at 2-week and 3-month follow-up periods. Half the participants in each group were followed by face-to-face home visit assessments as the gold standard. Validity was assessed by comparing any score differences between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Reliability was assessed by computing agreements between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Feasibility was evaluated by the levels of completion, satisfaction, comfort, and confidence in the 2 groups.
RESULTS
Scores obtained from the videoconference follow-up were similar to those of the home visit assessment. However, most scores collected from telephone administration were higher than those of the home visit assessment. The agreement between videoconference follow-up and home visit assessments was higher than that between telephone follow-up and home visit assessments at all follow-up periods. In the telephone follow-up group, completion rates were 95% and 82% at 2-week and 3-month follow-up points, respectively. In the videoconference follow-up group, completion rates were 95% and 80% at 2-week and 3-month follow-up points, respectively. There were no differences in the completion rates between the 2 groups at all follow-up periods (X 2 1 =1.6, P=.21 for 2-week follow-up; X 2 1 =1.9, P=.17 for 3-month follow-up). Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up). The videoconference follow-up group demonstrated higher satisfaction than the telephone follow-up group at 3-month follow-up (X 2 3 =13.9; P=.03).
CONCLUSIONS
The videoconference follow-up assessment of functional status demonstrates higher validity and reliability, as well as higher confidence and satisfaction perceived by patients, than the telephone assessment. The videoconference assessment provides an efficient means of assessing functional outcomes of patients after hospital discharge. This method provides a novel solution for clinical trials requiring longitudinal assessments.
TRIAL REGISTRATION
chictr.org.cn: ChiCTR1900027626; http://www.chictr.org.cn/edit.aspx?pid=44831&htm=4.",2020,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","['patients after hospital discharge', 'rehabilitation hospital in Southeast China', 'poststroke patients after rehabilitation hospitalization']","['videoconference follow-up (n=60) or a telephone follow-up', 'mobile phone-based app compared with administration through the telephone function']","['Reliability', 'completion rates', 'higher satisfaction', 'levels of completion, satisfaction, comfort, and confidence', 'higher confidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0461705,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jingsong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Shanjia', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Guanli', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jinxin', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Chetwyn C H', 'Initials': 'CCH', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, HongKong, Hong Kong.'}, {'ForeName': 'Lidian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Alex W K', 'Initials': 'AWK', 'LastName': 'Wong', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine, St. Louis, MO, United States.'}]",JMIR mHealth and uHealth,['10.2196/17219']
687,32401225,Social Media Interventions for Risky Drinking Among Adolescents and Emerging Adults: Protocol for a Randomized Controlled Trial.,"BACKGROUND
Despite intervention efforts to date, the prevalence of risky drinking among adolescents and emerging adults remains high, increasing the risk for health consequences and the development of alcohol use disorders. Peer influences are particularly salient among this age group, including via social media. Thus, the development of efficacious early interventions for youth, delivered with a broad reach via trained peers on social media, could have an important role in addressing risky drinking and concomitant drug use.
OBJECTIVE
This paper describes the protocol of a randomized controlled trial (RCT) testing the efficacy of a social media intervention among adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]), delivered with and without financial incentives for participation, compared with an attention placebo control condition (ie, entertaining social media content), on alcohol consumption and consequences.
METHODS
This RCT involved recruiting 955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey. Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ≥3 females and ≥4 males; and ages 18-24 years: ≥4 females and ≥5 males) were eligible for the RCT. After providing consent (a waiver of parental consent was obtained for minors), participants completed a web-based baseline survey and several verification procedures, including a selfie photo matched to Facebook profile photos. Participants were then randomized to join invitation-only secret Facebook groups, which were not searchable or viewable by parents, friends, or anyone not recruited by the study. The 3 conditions were social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control. Each condition lasted 8 weeks and consisted of bachelor's-level and master's-level therapist electronic coaches posting relevant content and responding to participants' posts in a manner consistent with Motivational Interviewing. Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions. Follow-ups are ongoing and occur at 3, 6, and 12 months poststart of the groups.
RESULTS
We enrolled 955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT.
CONCLUSIONS
The findings of this study will provide the critical next step in delivering early alcohol interventions to the youth, capitalizing on social media platforms, which could have significant public health impact by altering alcohol use trajectories of adolescents and emerging adults engaged in risky drinking.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02809586; https://clinicaltrials.gov/ct2/show/NCT02809586.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/16688.",2020,Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions.,"['955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey', 'Risky Drinking Among Adolescents and Emerging Adults', '955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT', 'Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ≥3 females and ≥4 males; and ages 18-24 years: ≥4 females and ≥5 males', 'adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C']","['Social Media Interventions', ""bachelor's-level and master's-level therapist electronic coaches posting relevant content and responding to participants' posts in a manner consistent with Motivational Interviewing"", 'social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control', 'social media intervention']",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],955.0,0.0843012,Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions.,"[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Schneeberger', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Bourque', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Bauermeister', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'Department of Informatics, Donald Bren School of Information and Computer Sciences, University of California Irvine, Irvine, CA, United States.'}, {'ForeName': 'Frederic C', 'Initials': 'FC', 'LastName': 'Blow', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amy Sb', 'Initials': 'AS', 'LastName': 'Bohnert', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Zimmerman', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/16688']
688,32403938,Effectiveness of embedding a specialist preventive care clinician in a community mental health service in increasing preventive care provision: A randomised controlled trial.,"OBJECTIVE
Clinical practice guidelines recommend that community mental health services provide preventive care for clients' chronic disease risk behaviours; however, such care is often not routinely provided. This study aimed to assess the effectiveness of offering clients an additional consultation with a specialist clinician embedded within a community mental health service, in increasing client-reported receipt of, and satisfaction with, preventive care.
METHOD
A randomised controlled trial was undertaken in one Australian community mental health service. Participants ( N = 811) were randomised to receive usual care (preventive care in routine consultations; n = 405) or usual care plus the offer of an additional consultation with a specialist preventive care clinician ( n = 406). Blinded interviewers assessed at baseline and 1-month follow-up the client-reported receipt of preventive care (assessment, advice and referral) for four key risk behaviours individually (smoking, poor nutrition, alcohol overconsumption and physical inactivity) and all applicable risks combined, acceptance of referrals and satisfaction with preventive care received.
RESULTS
Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]). For each component of care, there was a significant intervention effect for at least one of the individual risk behaviours. Participants reported high levels of satisfaction with preventive care received, ranging from 77% (assessment) to 87% (referral), with no significant differences between conditions.
CONCLUSION
The intervention had a significant effect on the provision of the majority of recommended elements of preventive care. Further research is needed to maximise its impact, including identifying strategies to increase client uptake.",2020,"RESULTS
Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]).","['one Australian community mental health service', 'Participants ( N \u2009=\u2009811', ""clients' chronic disease risk behaviours""]","['embedding a specialist preventive care clinician', 'preventive care (assessment, advice and referral) for four key risk behaviours individually (smoking, poor nutrition, alcohol overconsumption and physical inactivity', 'usual care (preventive care in routine consultations; n \u2009=\u2009405) or usual care plus the offer of an additional consultation with a specialist preventive care clinician']","['18 preventive care delivery outcomes', 'provision of the majority of recommended elements of preventive care']","[{'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2090905', 'cui_str': 'Specialist consultation'}]","[{'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}]",811.0,0.0905598,"RESULTS
Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]).","[{'ForeName': 'Caitlin Mc', 'Initials': 'CM', 'LastName': 'Fehily', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Bartlem', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Wiggers', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Wye', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Richard V', 'Initials': 'RV', 'LastName': 'Clancy', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Castle', 'Affiliation': 'Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Chris E', 'Initials': 'CE', 'LastName': 'Rissel', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Wutzke', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Hodder', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Colyvas', 'Affiliation': 'School of Mathematical and Physical Sciences, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Fionna', 'Initials': 'F', 'LastName': 'Murphy', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Bowman', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867420914741']
689,32404279,Stimulation of the vagus nerve reduces learning in a go/no-go reinforcement learning task.,"When facing decisions to approach rewards or to avoid punishments, we often figuratively go with our gut, and the impact of metabolic states such as hunger on motivation are well documented. However, whether and how vagal feedback signals from the gut influence instrumental actions is unknown. Here, we investigated the effect of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) vs. sham (randomized cross-over design) on approach and avoidance behavior using an established go/no-go reinforcement learning paradigm in 39 healthy human participants (23 female) after an overnight fast. First, mixed-effects logistic regression analysis of choice accuracy showed that taVNS acutely impaired decision-making, p = .041. Computational reinforcement learning models identified the cause of this as a reduction in the learning rate through taVNS (∆α = -0.092, p boot = .002), particularly after punishment (∆α Pun = -0.081, p boot = .012 vs. ∆α Rew =-0.031, p boot = .22). However, taVNS had no effect on go biases, Pavlovian response biases or response time. Hence, taVNS appeared to influence learning rather than action execution. These results highlight a novel role of vagal afferent input in modulating reinforcement learning by tuning the learning rate according to homeostatic needs.",2020,"First, mixed-effects logistic regression analysis of choice accuracy showed that taVNS acutely impaired decision-making, p = .041.",['39 healthy human participants (23 female) after an overnight fast'],['non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) vs. sham (randomized cross-over design'],"['go biases, Pavlovian response biases or response time']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",39.0,0.0349857,"First, mixed-effects logistic regression analysis of choice accuracy showed that taVNS acutely impaired decision-making, p = .041.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kühnel', 'Affiliation': 'Department of Translational Research in Psychiatry, Max Planck Institute of Psychiatry and International Max Planck Research School for Translational Psychiatry (IMPRS-TP), Munich, Germany. Electronic address: anne_kuehnel@psych.mpg.de.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teckentrup', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany.'}, {'ForeName': 'Monja P', 'Initials': 'MP', 'LastName': 'Neuser', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany.'}, {'ForeName': 'Quentin J M', 'Initials': 'QJM', 'LastName': 'Huys', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom; Max Planck UCL Centre for Computational Psychiatry and Ageing Research, London, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Burrasch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany; Otto-von-Guericke University Magdeburg, Department of Psychiatry and Psychotherapy, Magdeburg, Germany; Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany; Leibniz Institute for Neurobiology, Magdeburg, Germany.'}, {'ForeName': 'Nils B', 'Initials': 'NB', 'LastName': 'Kroemer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstr. 14, 72076 Tübingen, Germany. Electronic address: nils.kroemer@uni-tuebingen.de.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.03.023']
690,32187236,An internet-based mind/body intervention to mitigate distress in women experiencing infertility: A randomized pilot trial.,"OBJECTIVE
To determine if an internet-based mind/body program would lead to participants experiencing infertility (1) being willing to be recruited and randomized and (2) accepting and being ready to engage in a fertility-specific intervention. Secondary exploratory goals were to examine reduced distress over the course of the intervention and increased likelihood to conceive.
METHODS
This was a pilot randomized controlled feasibility trial with a between-groups, repeated measure design. Seventy-one women self-identified as nulliparous and meeting criteria for infertility. Participants were randomized to the internet-based version of the Mind/Body Program for Fertility or wait-list control group and asked to complete pre-, mid- and post-assessments. Primary outcomes include retention rates, number of modules completed, and satisfaction with intervention. Secondary exploratory outcomes sought to provide preliminary data on the impact of the program on distress (anxiety and depression) and self-reported pregnancy rates relative to a quasi-control group.
RESULTS
The retention, adherence, and satisfaction rates were comparable to those reported in other internet-based RCTs. Although time between pre- and post-assessment differed between groups, using intent-to-treat analyses, women in the intervention group (relative to the wait-list group) had significant reduction in distress (anxiety, p = .003; depression, p = .007; stress, p = .041 fertility-social, p = .018; fertility-sexual, p = .006), estimated as medium-to-large effect sizes (ds = 0.45 to 0.86). The odds of becoming pregnant was 4.47 times higher for the intervention group participants as compared to the wait-list group, OR 95% CI [1.56, 12.85], p = .005 and occurred earlier. The findings suggest that the research design and program specific to this population are feasible and acceptable. Replication efforts with an active control group are needed to verify distress reduction and conception promotion findings.",2020,"Participants were randomized to the internet-based version of the Mind/Body Program for Fertility or wait-list control group and asked to complete pre-, mid- and post-assessments.","['Seventy-one women self-identified as nulliparous and meeting criteria for infertility', 'participants experiencing infertility (1) being willing to be recruited and randomized and (2) accepting and being ready to engage in a fertility-specific intervention', 'women experiencing infertility']","['internet-based version of the Mind/Body Program for Fertility or wait-list control group and asked to complete pre-, mid- and post-assessments', 'internet-based mind/body intervention', 'internet-based mind/body program']","['retention rates, number of modules completed, and satisfaction with intervention', 'retention, adherence, and satisfaction rates', 'distress (anxiety', 'distress (anxiety and depression) and self-reported pregnancy rates']","[{'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",,0.0891781,"Participants were randomized to the internet-based version of the Mind/Body Program for Fertility or wait-list control group and asked to complete pre-, mid- and post-assessments.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Clifton', 'Affiliation': 'Department of Psychological Sciences, The University of Vermont, Burlington, Vermont, United States of America.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Parent', 'Affiliation': 'Department of Psychology, Florida International University, Miami, Florida, United States of America.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Seehuus', 'Affiliation': 'Department of Psychological Sciences, The University of Vermont, Burlington, Vermont, United States of America.'}, {'ForeName': 'Garyn', 'Initials': 'G', 'LastName': 'Worrall', 'Affiliation': 'Department of Medicine, Larner College of Medicine at The University of Vermont, Burlington, Vermont, United States of America.'}, {'ForeName': 'Rex', 'Initials': 'R', 'LastName': 'Forehand', 'Affiliation': 'Department of Psychological Sciences, The University of Vermont, Burlington, Vermont, United States of America.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Domar', 'Affiliation': 'Boston IVF, Waltham, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0229379']
691,31230889,Maintenance Following a Randomized Trial of a Clinic and Home-based Behavioral Intervention of Obesity in Preschoolers.,"OBJECTIVE
To assess maintenance of improved weight outcomes in preschoolers with obesity 6 and 12 months following a randomized clinical trial comparing a home- and clinic-based behavioral intervention (Learning about Activity and Understanding Nutrition for Child Health [LAUNCH]) to motivational interviewing and standard care.
STUDY DESIGN
Randomized controlled trial with children between the ages of 2 and 5 years above the 95th percentile for body mass index for age and sex recruited from 27 pediatrician offices across 10 recruitment cycles between March 12, 2012, and June 8, 2015, were followed 6 and 12 months post-treatment. Child and caregiver weight, height, and caloric intake, child physical activity, and home environment were assessed. The primary outcome was maintenance of greater reduction of percent over the 50th percentile body mass index (BMI%50th) by LAUNCH compared with motivational interviewing and standard care at the 6- and 12-month follow-up.
RESULTS
Significantly lower child BMI%50th was maintained for LAUNCH compared with motivational interviewing at 12-month follow-up and to standard care at the 6-month follow-up; however, the effect sizes were maintained for comparison with standard care at 12-month follow-up. LAUNCH had significantly lower daily caloric intake compared with motivational interviewing and standard care at both follow-ups and maintained significantly fewer high-calorie foods in the home compared with standard care at 6 and 12 months and compared with motivational interviewing at 12 months. However, caloric intake increased by 12% from post-treatment. LAUNCH caregivers did not maintain improved BMI at follow-up.
CONCLUSIONS
LAUNCH showed success in reducing weight in preschoolers. However, maintaining treatment gains post-treatment is more difficult. Treatment may need to last longer than 6 months to achieve optimal results.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT01546727.",2019,LAUNCH had significantly lower daily caloric intake compared with motivational interviewing and standard care at both follow-ups and maintained significantly fewer high-calorie foods in the home compared with standard care at 6 and 12 months and compared with motivational interviewing at 12 months.,"['preschoolers with obesity 6 and 12\xa0months', 'Obesity in Preschoolers', 'children between the ages of 2 and 5\xa0years above the 95th percentile for body mass index for age and sex recruited from 27 pediatrician offices across 10 recruitment cycles between March 12, 2012, and June 8, 2015, were followed 6 and 12\xa0months post-treatment']","['motivational interviewing and standard\xa0care', 'LAUNCH', 'home- and clinic-based behavioral intervention (Learning about Activity and Understanding Nutrition for Child Health [LAUNCH', 'Clinic and Home-based Behavioral Intervention']","['maintenance of greater reduction of percent over the 50th percentile body mass index\xa0(BMI%50th', 'weight outcomes', 'BMI', 'Child and caregiver weight, height, and caloric intake, child physical activity, and home environment', 'caloric intake', 'daily caloric intake']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0579991,LAUNCH had significantly lower daily caloric intake compared with motivational interviewing and standard care at both follow-ups and maintained significantly fewer high-calorie foods in the home compared with standard care at 6 and 12 months and compared with motivational interviewing at 12 months.,"[{'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Stark', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH. Electronic address: Lori.Stark@cchmc.org.""}, {'ForeName': 'Stephanie Spear', 'Initials': 'SS', 'LastName': 'Filigno', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Kichler', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bolling', 'Affiliation': 'Pediatric Associates, PSC, Crestview Hills, KY.'}, {'ForeName': 'Megan B', 'Initials': 'MB', 'LastName': 'Ratcliff', 'Affiliation': 'Independent Researcher, Atlanta, GA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Robson', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware, Newark, DE.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Simon', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'McCullough', 'Affiliation': 'Department of Psychology, Suffolk University, Boston, MA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Clifford', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Cathleen Odar', 'Initials': 'CO', 'LastName': 'Stough', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Zion', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Constance A', 'Initials': 'CA', 'LastName': 'Mara', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.05.004']
692,32200381,The Effect of Moderate Weight Loss on a Non-Invasive Biomarker of Liver Fibrosis: A Randomised Controlled Trial.,"BACKGROUND
Referral to weight loss programmes is the only effective treatment for non-alcoholic fatty liver disease (NAFLD). Clinicians should advise weight loss and screen for liver fibrosis using the Enhanced Liver Fibrosis (ELF) score.
AIM
To examine if the ELF score changes with weight loss.
DESIGN AND SETTING
Randomised controlled trial (ISRCTN85485463) in UK primary care during 2007-2008.
METHOD
Adults with a BMI of 27-35 kg/m2 and ≥1 risk factor for obesity-related disease were randomised to attend a community weight loss programme (n = 45) or receive usual weight loss advice from a practice nurse (n = 28). Weight and the ELF score were measured at baseline and 1 year. Analysis of covariance examined mean changes in the ELF score between groups and its relationship with weight loss.
RESULTS
Mean (SD) BMI was 31.10 kg/m2 (2.55) with evidence of moderate levels of liver fibrosis at baseline (mean ELF score: 8.93 [0.99]). There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30). Mean weight loss in the whole cohort was 7.8% (5.9). There was no evidence of an association between weight change and change in ELF; the coefficient for a 5% weight loss was -0.15 (95% CI: -0.30 to 0.0002).
CONCLUSION
We found no evidence that the ELF score changed meaningfully following moderate weight loss. Clinicians should not use the ELF score to measure improvements in NAFLD fibrosis following weight loss programmes.",2020,"There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30).","['Liver Fibrosis', 'Adults with a BMI of 27-35 kg/m2 and ≥1 risk factor for obesity-related disease']",['community weight loss programme (n = 45) or receive usual weight loss advice from a practice nurse'],"['Mean (SD) BMI', 'weight loss', 'ELF score', 'liver fibrosis', 'Weight and the ELF score', 'weight change and change in ELF', 'Mean weight loss']","[{'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse (occupation)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0843843,"There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30).","[{'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Koutoukidis', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom, dimitrios.koutoukidis@phc.ox.ac.uk.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",Obesity facts,['10.1159/000505667']
693,28942587,Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis.,"PURPOSE
The purpose of the study is to compare the efficacy of benzydamine HCl with sodium bicarbonate in the prevention of concurrent chemoradiation-induced oral mucositis in head and neck cancer patients.
METHODS
Sixty locally advanced head and neck cancer patients treated with high-dose radiotherapy concurrently with platinum-based chemotherapy were randomly assigned to receive either benzydamine HCl or sodium bicarbonate from the first day of treatment to 2 weeks after the completion of treatment. The total score for mucositis, based on the Oral Mucositis Assessment Scale (OMAS), was used for the assessment, conducted weekly during the treatment period and at the fourth week of the follow-up. Pain score, all prescribed medications, and tube feeding needs were also recorded and compared.
RESULTS
The median of total OMAS score was statistically significant lower in patients who received benzydamine HCl during concurrent chemo-radiotherapy (CCRT) than in those who received sodium bicarbonate, (p value < 0.001). There was no difference in median pain score, (p value = 0.52). Nineteen percent of patients in sodium bicarbonate arm needed oral antifungal agents whereas none in the benzydamine HCl arm required such medications, (p value = 0.06). Tube feeding needs and the compliance of CCRT were not different between the two study arms.
CONCLUSIONS
For patients undergoing high-dose radiotherapy concurrently with platinum-based chemotherapy, using benzydamine HCl mouthwash as a preventive approach was superior to basic oral care using sodium bicarbonate mouthwash in terms of reducing the severity of oral mucositis and encouraging trend for the less need of oral antifungal drugs.",2018,"There was no difference in median pain score, (p value = 0.52).","['head and neck cancer patients', 'patients undergoing high-dose', 'Sixty locally advanced head and neck cancer patients treated with high-dose radiotherapy concurrently with platinum-based chemotherapy']","['benzydamine HCl during concurrent chemo-radiotherapy (CCRT', 'benzydamine HCl versus sodium bicarbonate', 'radiotherapy', 'platinum-based chemotherapy, using benzydamine HCl mouthwash', 'benzydamine HCl or sodium bicarbonate', 'sodium bicarbonate', 'benzydamine HCl with sodium bicarbonate']","['oral mucositis', 'median of total OMAS score', 'severity of oral mucositis', 'Pain score, all prescribed medications, and tube feeding needs', 'total score for mucositis, based on the Oral Mucositis Assessment Scale (OMAS', 'median pain score', 'oral antifungal agents']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0041281', 'cui_str': 'Tube Feeding'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003308', 'cui_str': 'Fungicides, Therapeutic'}]",60.0,0.0197531,"There was no difference in median pain score, (p value = 0.52).","[{'ForeName': 'Imjai', 'Initials': 'I', 'LastName': 'Chitapanarux', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com.'}, {'ForeName': 'Tharatorn', 'Initials': 'T', 'LastName': 'Tungkasamit', 'Affiliation': 'Division of Radiation Oncology, Udornthani Cancer Hospital, Udon Thani, Thailand.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Petsuksiri', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Danita', 'Initials': 'D', 'LastName': 'Kannarunimit', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kanyarat', 'Initials': 'K', 'LastName': 'Katanyoo', 'Affiliation': 'Radiation Oncology Unit, Department of Radiology, Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand.'}, {'ForeName': 'Chakkapong', 'Initials': 'C', 'LastName': 'Chakkabat', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Setakornnukul', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Somying', 'Initials': 'S', 'LastName': 'Wongsrita', 'Affiliation': 'Division of Radiation Oncology, Maharaj Nakornratchasima Hospital, Nakornratchasima, Thailand.'}, {'ForeName': 'Naruemon', 'Initials': 'N', 'LastName': 'Jirawatwarakul', 'Affiliation': 'Division of Radiation Oncology, Udornthani Cancer Hospital, Udon Thani, Thailand.'}, {'ForeName': 'Chawalit', 'Initials': 'C', 'LastName': 'Lertbusayanukul', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Patumrat', 'Initials': 'P', 'LastName': 'Sripan', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Patrinee', 'Initials': 'P', 'LastName': 'Traisathit', 'Affiliation': 'Department of Statistics, Faculty of Science, Chiang Mai University, Chiang Mai, Thailand.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-017-3904-4']
694,32058976,"International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement.","BACKGROUND
Primary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain.
OBJECTIVE
This study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access to the full-featured study app and will be compared with 2 control groups who have access to fewer app features. Here, we report the trial design, app development, user access, and engagement.
METHODS
On the basis of the practical implications of the previous app-based study, we revised and reengineered the study app and included the ResearchKit (Apple Inc) framework. Behavior change techniques (BCTs) were implemented in the app and validated by expert ratings. User access was estimated by assessing recruitment progress over time. User evolution and baseline survey respondent rate were assessed to evaluate user engagement.
RESULTS
The development of the study app for a 3-armed randomized controlled trial required a multidisciplinary team. The app is accessible for the target population free of charge via the Apple App Store. In Germany, within 9 months, the app was downloaded 1458 times and 328 study participants were recruited using it without external advertising. A total of 98.27% (5157/5248) of the app-based baseline questions were answered. The correct classification of BCTs used in the app required psychological expertise.
CONCLUSIONS
Conducting an innovative app study requires multidisciplinary effort. Easy access and engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of user engagement, optimal BCT application, and potential clinical and self-care scenarios for app use.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ).",2020,A total of 98.27% (5157/5248) of the app-based baseline questions were answered.,"['18- to 34-year-old women with primary dysmenorrhea in a self-care setting', 'Women with Menstrual Pain', 'women of reproductive age']",['specific smartphone app'],"['Behavior change techniques (BCTs', 'menstrual pain']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}]",,0.176992,A total of 98.27% (5157/5248) of the app-based baseline questions were answered.,"[{'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Alizé A', 'Initials': 'AA', 'LastName': 'Rogge', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Armour', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Sydney, Australia.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Sydney, Australia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': ""D'Adamo"", 'Affiliation': 'Center for Integrative Medicine, School of Medicine, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Pischke', 'Affiliation': 'Institute of Medical Sociology, Centre for Health and Society, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Hung-Rong', 'Initials': 'HR', 'LastName': 'Yen', 'Affiliation': 'School of Chinese Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Mei-Yao', 'Initials': 'MY', 'LastName': 'Wu', 'Affiliation': 'Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Ari Ojeda Ocampo', 'Initials': 'AOO', 'LastName': 'Moré', 'Affiliation': 'Integrative Medicine and Acupuncture Division, University Hospital, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Witt', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pach', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}]",JMIR mHealth and uHealth,['10.2196/14661']
695,32181609,Long-term dentoskeletal changes of class II growing patients' treatment with the propulseur universal light appliance. A prospective controlled study.,"BACKGROUND
Class II is one of the most common malocclusions. The prevailing aspect in Class II patients is a mandibular deficiency. Various removable and fixed functional therapies are used in order to enhance the mandibular growth or position. The aim of this prospectively controlled study was to evaluate long-term dentoskeletal changes obtained by a functional appliance for Class II.
METHODS
Prospective controlled study, based on a sample size calculation. 26 Class II Division 1 patients (11.8±1.5 years) were consecutively treated with the propulseur universal light (PUL) appliance and a multi bracket appliance (PG), they were compared to a sample of 26 Class II untreated patients (11.5±0.8 years) (CG). Lateral cephalograms were taken before and after the PUL therapy, and after multibracket treatment. Interaction analysis was carried out to test whether the PUL parameters in treatment groups were different according to the acquisition times, using the Linear Mixed-Effects Model.
RESULTS
Significant ANB, Overjet and WITS differences existed in treatment groups according to the time. In particular, comparing to T1 vs. T0, the relative difference (RD) means in the control group were -0.34, -0.31 and 0.17 for ANB, Overjet and WITS, respectively. The corresponding RD means in the treated group PG were -1.58, -4.27 and -2.38. Comparing to T2 vs. T0, the RD means in the control group were -0.36, -0.51 and 0.63 for ANB, Overjet and WITS, respectively. While the corresponding RD means in the treated group were -2.08, -5.12 and -2.50.
CONCLUSIONS
The PUL appliance successfully corrected class II malocclusion. The long term correction was mainly due to dentoalveolar effects: therapy success was 91% for overjet correction and 76% for ANB correction. During the post functional appliance period, overjet was stable in 77% of the treated subjects, and ANB in 74% of the treated subjects.",2020,The long term correction was mainly due to dentoalveolar effects: therapy success was 91% for overjet cor- rection and 76% for ANB correction.,['26 Class II Divi- sion 1 patients (11.8 ± 1.5 years) were consecutively treated with the'],['PUL appliance and a multi bracket appliance (PG'],['dentoalveolar effects: therapy success'],"[{'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0449197', 'cui_str': 'PUL (body structure)'}, {'cui': 'C0243112'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0140321,The long term correction was mainly due to dentoalveolar effects: therapy success was 91% for overjet cor- rection and 76% for ANB correction.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Migliorati', 'Affiliation': 'Department of Orthodontics, School of Dentistry, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Drago', 'Affiliation': 'Department of Orthodontics, School of Dentistry, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Calzolari', 'Affiliation': 'Department of Orthodontics, School of Dentistry, University of Genoa, Genoa, Italy - chiara.calzo@hotmail.it.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Gallo', 'Affiliation': 'Section of Biostatistics, Department of Health Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Dalessandri', 'Affiliation': 'Department of Orthodontics, School of Dentistry, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Orsini', 'Affiliation': 'Department of Orthodontics, School of Dentistry, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Silvestrini-Biavati', 'Affiliation': 'Department of Orthodontics, School of Dentistry, University of Genoa, Genoa, Italy.'}]",Minerva stomatologica,['10.23736/S0026-4970.19.04283-3']
696,31756675,Elevated levels of IL-6 and IGFBP-1 predict low serum IGF-1 levels during continuous infusion of rhIGF-1/rhIGFBP-3 in extremely preterm infants.,"OBJECTIVE
Steady state insulin-like growth factor-1 (IGF-1) levels vary significantly during continuous intravenous infusion of recombinant human insulin-like growth factor-1/recombinant human insulin-like growth factor binding protein-3 (rhIGF-1/rhIGFBP-3) in the first weeks of life in extremely preterm infants. We evaluated interleukin-6 (IL-6) and insulin-like growth factor binding protein-1 (IGFBP-1) levels as predictors of low IGF-1 levels.
METHODS
Nineteen extremely preterm infants were enrolled in a trial, 9 received rhIGF-1/rhIGFBP-3 and 10 received standard neonatal care. Blood samples were analyzed daily for IGF-1, IL-6 and IGFBP-1 during intervention with rhIGF-1/rhIGFBP-3.
RESULTS
Thirty seven percent of IGF-1 values during active treatment were <20 μg/L. Among treated infants, higher levels of IL-6, one and two days before sampled IGF-1, were associated with IGF-1 < 20 μg/L, gestational age adjusted OR 1.30 (95% CI 1.03-1.63), p = .026, and 1.57 (95% CI 1.26-1.97), p < .001 respectively. Higher levels of IGFBP-1 one day before sampled IGF-1 was also associated with IGF-1 < 20 μg/L, gestational age adjusted OR 1.74 (95% CI 1.19-2.53), p = .004.
CONCLUSION
In preterm infants receiving continuous infusion of rhIGF-1/rhIGFBP-3, higher levels of IL-6 and IGFBP-1 preceded lower levels of circulating IGF-1. These findings demonstrate a need to further evaluate if inflammation and/or infection suppress serum IGF-1 levels. The trial is registered at ClinicalTrials.gov (NCT01096784).",2020,"Higher levels of IGFBP-1 one day before sampled IGF-1 was also associated with IGF-1 < 20 μg/L, gestational age adjusted OR 1.74 (95% CI 1.19-2.53), p = .004.
CONCLUSION
In preterm infants receiving continuous infusion of rhIGF-1/rhIGFBP-3, higher levels of IL-6","['Nineteen extremely preterm infants', 'extremely preterm infants']","['rhIGF-1/rhIGFBP-3 and 10 received standard neonatal care', 'rhIGF-1/rhIGFBP-3']","['levels of circulating IGF-1', 'levels of IL-6', 'serum IGF-1 levels', 'IGF-1 values', 'Elevated levels of IL-6', 'interleukin-6 (IL-6) and insulin-like growth factor binding protein-1 (IGFBP-1) levels']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0123256', 'cui_str': 'IGFBP-1'}]",19.0,0.379768,"Higher levels of IGFBP-1 one day before sampled IGF-1 was also associated with IGF-1 < 20 μg/L, gestational age adjusted OR 1.74 (95% CI 1.19-2.53), p = .004.
CONCLUSION
In preterm infants receiving continuous infusion of rhIGF-1/rhIGFBP-3, higher levels of IL-6","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Klevebro', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden. Electronic address: susanna.klevebro@ki.se.'}, {'ForeName': 'Gunnel', 'Initials': 'G', 'LastName': 'Hellgren', 'Affiliation': 'Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden; Institute of Bioscience, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Hansen-Pupp', 'Affiliation': 'Lund University, Skåne University Hospital, Department of Clinical Sciences Lund, Pediatrics, Lund, Sweden.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Wackernagel', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Boubou', 'Initials': 'B', 'LastName': 'Hallberg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Borg', 'Affiliation': 'Former Premacure AB, Uppsala, Sweden.'}, {'ForeName': 'Aldina', 'Initials': 'A', 'LastName': 'Pivodic', 'Affiliation': 'Statistiska konsultgruppen, Gothenburg, Sweden.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': ""Department of Ophthalmology, Boston Children's Hospital, Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ley', 'Affiliation': 'Lund University, Skåne University Hospital, Department of Clinical Sciences Lund, Pediatrics, Lund, Sweden.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hellström', 'Affiliation': 'Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2019.11.001']
697,31356278,Perioperative FOLFOX 4 Versus FOLFOX 4 Plus Cetuximab Versus Immediate Surgery for High-Risk Stage II and III Colon Cancers: A Phase II Multicenter Randomized Controlled Trial (PRODIGE 22).,"BACKGROUND
Perioperative chemotherapy has proven valuable in several tumors, but not in colon cancer (CC).
OBJECTIVE
The aim of this study was to evaluate the efficacy and safety of perioperative chemotherapy in patients with locally advanced nonmetastatic CC.
METHODS
This is a French multicenter randomized phase II trial in patients with resectable high-risk T3, T4, and/or N2 CC on baseline computed tomography (CT) scan. Patients were randomized to receive either 6 months of adjuvant FOLFOX after colectomy (control) or perioperative FOLFOX for 4 cycles before surgery and 8 cycles after (FOLFOX peri-op). In RAS wild-type patients, a third arm testing perioperative FOLFOX-cetuximab was added. Tumor Regression Grade (TRG1) of Ryan et al was the primary endpoint. Secondary endpoints were toxicity, perioperative morbidity, and quality of surgery.
RESULTS
A total of 120 patients were enrolled. At interim analysis, the FOLFOX-cetuximab arm was stopped (lack of efficacy). The remaining 104 patients (control, n = 52; FOLFOX preop n = 52) represented our intention-to-treat population. In the FOLFOX perioperative group, 96% received the scheduled 4 cycles before surgery. R0 resection and complete mesocolic excision rate were 94% and 93%, respectively. Overall mortality and morbidity rates were similar in both groups. Perioperative FOLFOX chemotherapy did not improve major pathological response rate (TRG1 = 8%) but was associated with a significant pathological regression (TRG1-2 = 44% vs 8%, P < 0.001) and a trend to tumor downstaging as compared to the control group. CT scan criteria were associated with a 33% rate of overstaging in control group.
CONCLUSIONS
Perioperative FOLFOX for locally advanced resectable CC is feasible with an acceptable tolerability but is not associated with an increased major pathological response rate as expected. However, perioperative FOLFOX induces pathological regression and downstaging. Better preoperative staging tools are needed to decrease the risk of overtreating patients.",2020,"CONCLUSIONS
Perioperative FOLFOX for locally advanced resectable CC is feasible with an acceptable tolerability but is not associated with an increased major pathological response rate as expected.","['patients with locally advanced nonmetastatic CC', '120 patients were enrolled', 'patients with resectable high-risk T3, T4, and/or N2 CC on baseline computed tomography (CT) scan', 'High-Risk Stage II and III Colon Cancers', '104 patients (control, n = 52; FOLFOX preop n = 52) represented our intention-to-treat population']","['perioperative chemotherapy', 'Perioperative FOLFOX chemotherapy', 'adjuvant FOLFOX after colectomy (control) or perioperative FOLFOX', 'FOLFOX 4 Plus Cetuximab', 'FOLFOX-cetuximab']","['toxicity, perioperative morbidity, and quality of surgery', 'Overall mortality and morbidity rates', 'major pathological response rate', 'R0 resection and complete mesocolic excision rate', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0009274', 'cui_str': 'Large Bowel Resection'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.0466212,"CONCLUSIONS
Perioperative FOLFOX for locally advanced resectable CC is feasible with an acceptable tolerability but is not associated with an increased major pathological response rate as expected.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Karoui', 'Affiliation': 'Medicine Sorbonne University, Paris VI, AP-HP.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rullier', 'Affiliation': 'Department of Pathology, Pellegrin University Hospital, Bordeaux, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Department of Digestive and Oncological Surgery, Lille University Hospital, Lille, France.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Legoux', 'Affiliation': 'Department of Gastroenterology, CHR La Source, Orléans, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Barbier', 'Affiliation': 'Biostatistics, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De Chaisemartin', 'Affiliation': 'Department of Digestive Surgery, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lecaille', 'Affiliation': 'Department of Oncology, Polyclinique Bordeaux Nord, Bordeaux, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bouche', 'Affiliation': 'Department of Medicine-Oncology, CHU Robert Debré, Reims, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ammarguellat', 'Affiliation': 'Department of Medical Oncology, CH Beauvais, Beauvais, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brunetti', 'Affiliation': 'Department of Digestive Surgery, AP-HP, CHU Henri Mondor, Créteil, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Prudhomme', 'Affiliation': 'Department of Digestive Surgery, CHU Carémeau, Nîmes, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Regimbeau', 'Affiliation': 'Department of Digestive Surgery, Amiens University Hospital, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Glehen', 'Affiliation': 'Department of Digestive Surgery, CHU Lyon Sud, Lyon, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lievre', 'Affiliation': 'Department of Gastroenterology, CHU Rennes, Rennes 1 University, Rennes, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Portier', 'Affiliation': 'Department of Digestive Surgery, CHU Purpan, Toulouse, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hartwig', 'Affiliation': 'Department of Gastroenterology, Infirmerie Protestante, Caluire-et-Cuire, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Goujon', 'Affiliation': 'Department of Gastroenterology, Paris VII, AP-HP, BCHU Bichat, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Romain', 'Affiliation': 'Department of Digestive Surgery, CHU Hautepierre, Strasbourg, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Hepatogastroenterology and Digestive Oncology department, CHU Dijon, University of Burgundy and Franche Comté, FFCD, EPICAD INSERM LNC-UMR 1231, Dijon, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Sorbonne Paris Cité, Paris Descartes University, AP-HP.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003454']
698,31083047,Low-Carbohydrate Training Increases Protein Requirements of Endurance Athletes.,"INTRODUCTION
Training with low-carbohydrate (CHO) availability enhances markers of aerobic adaptation and has become popular to periodize throughout an endurance-training program. However, exercise-induced amino acid oxidation is increased with low muscle glycogen, which may limit substrate availability for postexercise protein synthesis. We aimed to determine the impact of training with low-CHO availability on estimates of dietary protein requirements.
METHODS
Eight endurance-trained males (27 ± 4 yr, 75 ± 10 kg, 67 ± 10 mL·kg body mass·min) completed two trials matched for energy and macronutrient composition but with differing CHO periodization. In the low-CHO availability trial (LOW), participants consumed 7.8 g CHO·kg before evening high-intensity interval training (10 × 5 min at 10-km race pace, 1 min rest) and subsequently withheld CHO postexercise (0.2 g·kg). In the high-CHO availability trial (HIGH), participants consumed 3 g CHO·kg during the day before high-intensity interval training, and consumed 5 g CHO·kg that evening to promote muscle glycogen resynthesis. A 10-km run (~80% HRmax) was performed the following morning, fasted (LOW) or 1 h after consuming 1.2 g CHO·kg (HIGH). Whole-body phenylalanine flux and oxidation were determined over 8 h of recovery via oral [C]phenylalanine ingestion, according to standard indicator amino acid oxidation methodology, while consuming sufficient energy, 7.8 g CHO·kg·d, and suboptimal protein (0.93 g·kg·d).
RESULTS
Fat oxidation (indirect calorimetry) during the 10-km run was higher in LOW compared with HIGH (0.99 ± 0.35 g·min vs 0.60 ± 0.26 g·min, P < 0.05). phenylalanine flux during recovery was not different between trials (P > 0.05) whereas phenylalanine oxidation (reciprocal of protein synthesis) was higher in LOW compared with HIGH (8.8 ± 2.7 μmol·kg·h vs 7.9 ± 2.4 μmol·kg·h, P < 0.05), suggesting a greater amino acid requirement to support rates of whole-body protein synthesis.
CONCLUSIONS
Our findings suggest that performing endurance exercise with low-CHO availability increases protein requirements of endurance athletes.",2019,"PheRa during recovery was not different between trials (p>0.05) whereas PheOX (reciprocal of protein synthesis) was higher in LOW compared to HIGH (8.8±2.7 vs. 7.9±2.4 umol·kg·h, p<0.05), suggesting a greater amino acid requirement to support rates of whole-body protein synthesis.
","['Endurance Athletes', 'endurance athletes', 'Eight endurance-trained males (27±4y, 75±10kg, 67±10ml·kg body mass·min) completed two trials matched for energy and macronutrient composition but with differing CHO periodization']","['Low-Carbohydrate Training', 'Training with low-carbohydrate (CHO', 'Whole-body phenylalanine flux (PheRa) and oxidation (PheOx', 'endurance exercise with low-CHO availability']","['PheOX (reciprocal of protein synthesis', 'PheRa during recovery', 'Fat oxidation (indirect calorimetry']","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}]",,0.0884978,"PheRa during recovery was not different between trials (p>0.05) whereas PheOX (reciprocal of protein synthesis) was higher in LOW compared to HIGH (8.8±2.7 vs. 7.9±2.4 umol·kg·h, p<0.05), suggesting a greater amino acid requirement to support rates of whole-body protein synthesis.
","[{'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Gillen', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, CANADA.'}, {'ForeName': 'Daniel W D', 'Initials': 'DWD', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Williamson', 'Affiliation': ''}, {'ForeName': 'Hugo J W', 'Initials': 'HJW', 'LastName': 'Fung', 'Affiliation': ''}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Moore', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002036']
699,31107348,Optimal Approach to Load Progressions during Strength Training in Older Adults.,"Progressive resistance training (RT) is one of the most effective interventions for reducing age-related deficits in muscle mass and functional capacity.
PURPOSE
To compare four approaches to load progressions in RT for older adults to determine if an optimal method exists.
METHODS
Eighty-two healthy community-dwelling older adults (71.8 ± 6.2 yr) performed 11 wk of structured RT (2.5 d·wk) in treatment groups differing only by the method used to increase training loads. These included percent one repetition maximum (%1RM): standardized loads based on a percentage of the one repetition maximum (1RM); rating of perceived exertion (RPE): loads increased when perceived difficulty falls below 8/10 on the OMNI-Resistance Exercise Scale perceived exertion scale; repetition maximum (RM): loads increased when a target number of repetitions can be completed with a given load; repetitions in reserve (RiR): identical to RM except subjects must always maintain ≥1 ""repetition in reserve,"" thus avoiding the possibility of training to temporary muscular failure.
RESULTS
Multiple analyses of covariance indicated no significant between-group differences on any strength (chest press 1RM; leg press 1RM) or functional performance outcome (usual walking speed, maximum walking speed, 8-ft timed up-and-go, gallon jug transfer test, 30 s sit-to-stand). The RPE group found the exercise to be significantly more tolerable and enjoyable than subjects in the RiR, RM, and %1RM groups.
CONCLUSION
Given the RM, RPE, %1RM, and RiR methods appear equally effective at improving muscular strength and functional performance in an older population, we conclude that the RPE method is optimal because it is likely to be perceived as the most tolerable and enjoyable, which are two important factors determining older adults' continued participation in RT.",2019,"%1RM, and RiR methods appear equally-effective at improving muscular strength and functional performance in an older population, we conclude that the RPE method is optimal because it is likely to be perceived as the most tolerable and enjoyable, which are two important factors determining older adults' continued participation in RT.","['82 healthy community-dwelling older adults (71.8 + 6.2 y', 'Older Adults', 'older adults']","['Progressive resistance training (RT', 'structured RT']","['repetition maximum (1RM', 'tolerable and enjoyable', ' rating of perceived exertion (RPE', 'muscular strength and functional performance', 'strength (chest press 1RM; leg press 1RM) or functional performance outcome (usual walking speed, maximum walking speed, 8 foot timed up-and-go, gallon jug transfer test, 30 second sit-to-stand', 'exertion scale; repetition maximum (RM): loads']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517820', 'cui_str': '6.2'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1705853', 'cui_str': 'Imperial gallon'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0222045'}]",82.0,0.016822,"%1RM, and RiR methods appear equally-effective at improving muscular strength and functional performance in an older population, we conclude that the RPE method is optimal because it is likely to be perceived as the most tolerable and enjoyable, which are two important factors determining older adults' continued participation in RT.","[{'ForeName': 'Andrew N L', 'Initials': 'ANL', 'LastName': 'Buskard', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, Coral Gables, FL.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Jacobs', 'Affiliation': 'Department of Kinesiology and Sport Sciences, University of Miami, Coral Gables, FL.'}, {'ForeName': 'Moataz M', 'Initials': 'MM', 'LastName': 'Eltoukhy', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, Coral Gables, FL.'}, {'ForeName': 'Keri L', 'Initials': 'KL', 'LastName': 'Strand', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, Coral Gables, FL.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Villanueva', 'Affiliation': 'Department of Kinesiology and Sport Sciences, University of Miami, Coral Gables, FL.'}, {'ForeName': 'Parth P', 'Initials': 'PP', 'LastName': 'Desai', 'Affiliation': 'Department of Kinesiology and Sport Sciences, University of Miami, Coral Gables, FL.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Signorile', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, Coral Gables, FL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002038']
700,31145180,High-Intensity Single-Leg Cycling Improves Cardiovascular Disease Risk Factor Profile.,"INTRODUCTION
Regular exercise can reduce the risk of developing cardiovascular disease through risk factor modification, with high-intensity exercise and more recently small muscle mass training providing alternatives to moderate-intensity exercise.
METHODS
This study randomly assigned 53 healthy middle-age adults (age, 62 ± 6 yr) to complete 24 sessions (8 wk; 3 d·wk) of exercise training, using either high-intensity double-leg cycling (n = 17; HITDL), high-intensity single-leg cycling (n = 18; HITSL), or moderate-intensity double-leg cycling (n = 18; MCTDL). Biomarkers of cardiovascular risk (total cholesterol, triglycerides, HDL-c, LDL-c, apo-B48, and glucose), anthropometry measures (body mass, body mass index, waist circumference, and waist-to-hip ratio), resting blood pressure, and aerobic capacity were assessed pre- and postintervention.
RESULTS
Total work completed was greater (P < 0.01) in MCTDL (5938 ± 1462 kJ) compared with the HITDL (3462 ± 1063 kJ) and HITSL (4423 ± 1875 kJ). Pre- to posttraining differences were observed for waist-to-hip ratio (0.84 ± 0.09 vs 0.83 ± 0.09; P < 0.01), resting systolic blood pressure (129 ± 11 vs 124 ± 12 mm Hg; P < 0.01), total cholesterol (5.87 ± 1.17 vs 5.55 ± 0.98 mmol·L; P < 0.01), and LDL-c (3.70 ± 1.04 vs 3.44 ± 0.84 mmol·L; P < 0.01), with no differences between conditions. In addition, aerobic capacity increased after training (22.3 ± 6.4 vs 24.9 ± 7.6 mL·kg·min; P < 0.01), with no differences between conditions.
CONCLUSION
These findings suggest that all three modes of exercise can be prescribed to achieve cardiovascular risk reduction in an aging population.",2019,"RESULTS
Total work completed was greater (p<0.01) in MCTDL (5938 ± 1462 kJ) compared with the HITDL (3462 ± 1063 kJ) and HITSL (4423 ± 1875 kJ).",['53 healthy middle-aged adults (age: 62 ± 6 y'],"['exercise training, using either high intensity double-leg cycling (n=17; HITDL), high intensity single-leg cycling (n=18; HITSL) or moderate intensity double-leg cycling ', 'High-Intensity Single-Leg Cycling']","['total cholesterol', 'aerobic capacity', 'resting systolic blood pressure', 'cardiovascular risk (total cholesterol, triglycerides, HDL-c, LDL-c, apo-B48, glucose), anthropometry measures (body mass, body mass index, waist circumference, waist-to-hip ratio), resting blood pressure and aerobic capacity', 'cardiovascular risk reduction']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",53.0,0.105455,"RESULTS
Total work completed was greater (p<0.01) in MCTDL (5938 ± 1462 kJ) compared with the HITDL (3462 ± 1063 kJ) and HITSL (4423 ± 1875 kJ).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gordon', 'Affiliation': 'School of Psychology and Exercise Science, Murdoch University, Perth, AUSTRALIA.'}, {'ForeName': 'Chris R', 'Initials': 'CR', 'LastName': 'Abbiss', 'Affiliation': 'Centre for Exercise and Sport Science Research, School of Exercise and Health Science, Edith Cowan University, Joondalup, AUSTRALIA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, AUSTRALIA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'James', 'Affiliation': 'School of Public Health, Curtin University, Perth, AUSTRALIA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'School of Public Health, Curtin University, Perth, AUSTRALIA.'}, {'ForeName': 'Kieran J', 'Initials': 'KJ', 'LastName': 'Marston', 'Affiliation': 'School of Psychology and Exercise Science, Murdoch University, Perth, AUSTRALIA.'}, {'ForeName': 'Jeremiah J', 'Initials': 'JJ', 'LastName': 'Peiffer', 'Affiliation': 'School of Psychology and Exercise Science, Murdoch University, Perth, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002053']
701,32402650,"Task experience eliminates catecholaminergic effects on inhibitory control - A randomized, double-blind cross-over neurophysiological study.","Catecholaminergic neural transmission plays an important role during the inhibition of prepotent responses. Methylphenidate (MPH) is an important drug that modulates the catecholaminergic system. However, theoretical considerations suggest that the effects of drugs (e.g. MPH) on cognitive control may depend on prior learning effects. Here we investigate this in a conflict-modulated Go/Nogo task and evaluate neurophysiological processes associated with this dynamic using EEG signal decomposition methods and source localization analysis. The behavioral data show that prior learning experiences eliminate effects of MPH on response inhibition processes. On a neurophysiological level, we show that MPH modulates specific processes in medial frontal brain regions. Although MPH seems to consistently modulate neurophysiological processes associated with response inhibition, this is no longer sufficient to modulate behavioral performance once learning or task familiarization processes have taken place. An important consequence of this study finding is that it may be important to adjust MPH dosage depending on learning effects in a specific setting to constantly increase cognitive control functions in that setting. This has important implications for clinical practice, since MPH is the first-line pharmacological therapy in attention-deficit hyperactivity disorder (ADHD). Cross-over study designs with constant doses of MPH can mask effects on cognitive functions. The impact of learning needs careful consideration in cross-over study designs examining catecholaminergic drug effects.",2020,"Although MPH seems to consistently modulate neurophysiological processes associated with response inhibition, this is no longer sufficient to modulate behavioral performance once learning or task familiarization processes have taken place.",[],['Methylphenidate (MPH'],"['cognitive control functions', 'cognitive functions', 'catecholaminergic effects']",[],"[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0560393,"Although MPH seems to consistently modulate neurophysiological processes associated with response inhibition, this is no longer sufficient to modulate behavioral performance once learning or task familiarization processes have taken place.","[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Mückschel', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine of the TU Dresden, Schubertstraße 42, D-01309 Dresden, Germany.'}, {'ForeName': 'Veit', 'Initials': 'V', 'LastName': 'Roessner', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine of the TU Dresden, Schubertstraße 42, D-01309 Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine of the TU Dresden, Schubertstraße 42, D-01309 Dresden, Germany. Electronic address: christian.beste@uniklinikum-dresden.de.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.03.013']
702,32272079,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30257-7.,,2020,,[],[],[],[],[],[],,0.0200868,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30283-8']
703,32405071,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).,"Background
Angiotensin-converting enzyme-2 (ACE2) may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 32 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels.
Summary
BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,"Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels.
","['patients with COVID-19', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB', '500 participants at 32 sites in Brazil', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', '\n\n\nAngiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels', 'median days alive and out of the hospital at 30\xa0days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.154131,"Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels.
","[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}]",American heart journal,['10.1016/j.ahj.2020.05.002']
704,32160205,Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial.,"Measuring blood pressure (BP) at home and remote monitoring can improve the patient's adherence to BP control and vascular outcomes. This study evaluated the feasibility of a trial regarding the effects of an intensive mobile BP management strategy versus usual care in acute ischemic stroke patients. A feasibility-testing, randomized, open-labeled controlled trial was conducted. Remote BP measurement, data transmission, storage, and centralized monitoring system were organized through a Bluetooth-equipped sphygmomanometer paired to the participants' smartphones. Participants were randomized equally into intensive management (behavioral intensification to measure BP at home by texting, direct telephone call, or breakthrough visit) and control (usual care) groups. The primary feasibility outcomes were: 1) recruitment time for the pre-specified number of participants, 2) retention of participants, 3) frequency of breakthrough visit calls, 4) response to breakthrough visit call, and 5) proportions satisfying BP measurement criteria. Sixty participants were randomly assigned to the intensive management (n = 31) and control (n = 29) groups, of which 57 participants were included in the primary analysis with comparable baseline characteristics. Recruitment time from the first to the last participant was 350 days, and 95% of randomized participants completed the final visit (intensive, 94%; control, 98%). Eight breakthrough visit calls were made to 7 participants (23%), with complete and immediate responses within 3 ± 4 days. The median of half-day blocks fulfilling the BP measurement criteria per patient were 91% in the intensive group and 83% in the control group (difference, 12.2; 95% confidence interval, 2.2-22.2). No adverse events related to the trial procedures were reported. The intensive monitoring, including remote BP measurement, data transfer, and centralized monitoring system, engaged with behavioral intensification was feasible if the patients complied with the intervention. However, the device utilized would need further improvement prior to a large trial.",2020,No adverse events related to the trial procedures were reported.,"['stroke', 'Sixty participants', 'acute ischemic stroke patients']","['intensive mobile BP management strategy versus usual care', 'intensive management (behavioral intensification to measure BP at home by texting, direct telephone call, or breakthrough visit) and control (usual care) groups', 'intensive management']","['Measuring blood pressure (BP', 'median of half-day blocks fulfilling the BP measurement criteria per patient', 'Remote BP measurement, data transmission, storage, and centralized monitoring system', '1) recruitment time for the pre-specified number of participants, 2) retention of participants, 3) frequency of breakthrough visit calls, 4) response to breakthrough visit call, and 5) proportions satisfying BP measurement criteria']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",57.0,0.095621,No adverse events related to the trial procedures were reported.,"[{'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology and Cerebrovascular Center, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jong-Moo', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Nowon Eulji Medical Center, Department of Neurology, Eulji University, Seoul, Republic of Korea.'}, {'ForeName': 'Tai Hwan', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Seoul Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Joungsim', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology and Cerebrovascular Center, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'JongShill', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Engineering, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Keon-Joo', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology and Cerebrovascular Center, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'JiSung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Chae', 'Affiliation': 'Department of Biostatistics, College of Medicine, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Juneyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, College of Medicine, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Hee-Joon', 'Initials': 'HJ', 'LastName': 'Bae', 'Affiliation': 'Department of Neurology and Cerebrovascular Center, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0229483']
705,30128855,Qigong intervention for breast cancer survivors with complaints of decreased cognitive function.,"PURPOSE
The purpose of this pilot study was to evaluate the feasibility of an 8-week Qigong intervention to improve objectively and subjectively assessed cognitive function in breast cancer survivors who were 2 months to 8 years post completion of chemotherapy and radiation therapy.
METHODS
A randomized, single-blind, three-arm intervention pilot was conducted to compare Qigong to gentle exercise and survivorship support. Feasibility was measured by recruitment, group session attendance, and adherence to home practice for the two exercise groups. Changes in self-report and objectively measured cognitive function were compared between the three groups from baseline (T1) to completion of the intervention (T2) and 4 weeks post intervention (T3).
RESULTS
Fifty participants consented (83% of desired sample) with an overall attrition rate of 28%. Attrition was highest for the gentle exercise group (50%). Group attendance adherence ranged from 44 to 67%. The a priori established rate of 75% weekly attendance was not achieved, nor was the goal of 75% adherence to home practice for the two exercise groups (7 to 41%). Self-report of cognitive function improved most for the Qigong group (p = .01). Improvement was demonstrated for the Trail Making A (gentle exercise, p = .007) and F-A-S verbal fluency (support group, p = .02) tests. Qigong participants reported the most reduction of distress (p = .02).
CONCLUSIONS
The study results suggest that mindfulness-based exercise may be superior to gentle exercise alone or survivorship support for improving self-report of cognitive function and distress after treatment for breast cancer. The mindfulness component may enhance the positive impact of exercise on cognitive function.",2019,"Improvement was demonstrated for the Trail Making A (gentle exercise, p = .007) and F-A-S verbal fluency (support group, p = .02) tests.","['breast cancer survivors who were 2\xa0months to 8\xa0years post completion of chemotherapy and radiation therapy', 'breast cancer survivors with complaints of decreased cognitive function']","['Qigong intervention', 'Qigong to gentle exercise and survivorship support']","['overall attrition rate', 'Changes in self-report and objectively measured cognitive function', 'F-A-S verbal fluency', 'Attrition', 'Self-report of cognitive function', 'distress']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]","[{'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038955'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",50.0,0.0345359,"Improvement was demonstrated for the Trail Making A (gentle exercise, p = .007) and F-A-S verbal fluency (support group, p = .02) tests.","[{'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Myers', 'Affiliation': 'Office of Grants and Research, University of Kansas School of Nursing, MS 4043, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA. jmyers@kumc.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Krigel', 'Affiliation': 'Midwest Cancer Alliance, University of Kansas Medical Center, 4350 Shawnee Mission Parkway, Fairway, KS, 66205, USA.'}, {'ForeName': 'Andreanna', 'Initials': 'A', 'LastName': 'Steinhoff', 'Affiliation': 'Office of Grants and Research, University of Kansas School of Nursing, MS 4043, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Boyce-White', 'Affiliation': 'University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Van Goethem', 'Affiliation': 'Midwest Cancer Alliance, University of Kansas Medical Center, 4350 Shawnee Mission Parkway, Fairway, KS, 66205, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Valla', 'Affiliation': 'North Kansas City Hospital, 2750 Clay Edwards Drive, North Kansas City, MO, 64116, USA.'}, {'ForeName': 'Junqiang', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Jianghua', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'Center for Research and Evaluation, University of Pittsburgh School of Nursing, 3500 Victoria St, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bender', 'Affiliation': 'Nancy Glunt Hoffman Endowed Chair of Oncology Nursing, University of Pittsburgh School of Nursing, 3500 Victoria St, Pittsburgh, PA, 15213, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4430-8']
706,32171600,Effect of Preoperative Intramuscular Injection of Botulinum Toxin A on Pain and Mouth Opening After Surgical Intervention in Temporomandibular Joint Ankylosis Cases: A Controlled Clinical Trial.,"PURPOSE
The aim of the present study was to determine the effect of intramuscular injection of botulinum toxin A (BTX-A) into the masticatory muscles on the physiotherapy pain and mouth opening outcomes after surgical intervention of temporomandibular joint (TMJ) ankylosis and to verify the effects using electromyographic studies.
PATIENTS AND METHODS
The study included 20 patients with TMJ ankylosis. The patients were further subdivided into control and interventional groups. The interventional group was given intramuscular injections of BTX-A in the masticator muscles before surgery. Only saline injections were given to the control group. All 20 patients were evaluated for pain and ease of active physiotherapy at the 1-week and 1-, 3-, and 6-month follow-up visits using a questionnaire. Intergroup comparisons were performed for both groups. Electromyographic (EMG) studies were also performed in the intervention group for each patient. EMG recordings were performed of the individual masticator muscle in each patient before injection and at 1 and 3 months after injection.
RESULTS
The intervention group showed better results with respect to pain during the mouth opening exercises and improvements in mouth opening. All the interventional group patients showed a transient decrease in the microvolt value on the EMG studies of their masticator muscles on injection of BTX-A.
CONCLUSIONS
BTX-A injection can be a straightforward and useful adjunct to surgical treatment of TMJ ankylosis for the reduction of pain during postoperative physiotherapy.",2020,BTX-A injection can be a straightforward and useful adjunct to surgical treatment of TMJ ankylosis for the reduction of pain during postoperative physiotherapy.,"['20 patients with TMJ ankylosis', 'Temporomandibular Joint Ankylosis Cases']","['botulinum toxin A (BTX-A', 'Botulinum Toxin A']","['Pain and Mouth Opening', 'pain and ease of active physiotherapy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}, {'cui': 'C2931375', 'cui_str': 'Temporomandibular ankylosis'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",20.0,0.0250176,BTX-A injection can be a straightforward and useful adjunct to surgical treatment of TMJ ankylosis for the reduction of pain during postoperative physiotherapy.,"[{'ForeName': 'Saatvik', 'Initials': 'S', 'LastName': 'Shandilya', 'Affiliation': 'Postgraduate Student, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India. Electronic address: drsujatam@hotmail.com.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Chaudhary', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Sanchaita', 'Initials': 'S', 'LastName': 'Kohli', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Rudra Deo', 'Initials': 'RD', 'LastName': 'Kumar', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.02.011']
707,32492084,Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial.,"Importance
Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.
Objective
To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.
Design, Setting, and Participants
Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.
Intervention
Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity.
Main Outcomes and Measures
Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.
Results
Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.65 [95% CI, 0.29-1.46]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.93]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.
Conclusion and Relevance
Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.
Trial Registration
Chinese Clinical Trial Registry: ChiCTR2000029757.",2020,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","['patients with COVID-19', 'patients with coronavirus disease 2019 (COVID-19', '60 [58.3%] male), 101 (98.1%) completed the trial', '103 of a planned 200 patients were enrolled', '103 patients who were randomized (median age, 70 years', 'Patients With Severe and Life-threatening COVID-19', '103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation', '7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020']","['Convalescent Plasma Therapy', 'convalescent plasma therapy', 'Intervention\n\n\nConvalescent plasma in addition to standard treatment (n\u2009=\u200952) vs standard treatment alone (control']","['Clinical improvement', 'time to clinical improvement', '28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR', '28-day mortality', 'adverse events', 'efficacy and adverse effects', 'time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale', 'negative conversion rate of viral PCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1299454', 'cui_str': 'Patient discharged alive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",103.0,0.448056,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xunliang', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Hospital, National Respiratory quality control center, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Shangen', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Transfusion, General Hospital of Central Theater Command of PLA, Wuhan, China.'}, {'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Medical Molecular Biology, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & Peking Union, Beijing, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Caiying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Cuihua', 'Initials': 'C', 'LastName': 'Tao', 'Affiliation': 'Department of Blood Transfusion, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Wuhan Blood Center, Wuhan, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Yongpei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Xiaoxiong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Xiong', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Wuhan Pulmonary Hospital, Wuhan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Man', 'Affiliation': 'Department of Respiratory Medicine, Wuhan Asia General Hospital, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deng', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Chenyue', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shisheng', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Global Health and Infectious Diseases, Comprehensive AIDS Research Center, and Beijing Advanced Innovation Center for Structural Biology, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanyun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology, University of Miami, Miami, Florida.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}]",JAMA,['10.1001/jama.2020.10044']
708,32185595,"A prospective randomized trial comparing corifollitropin-α late-start (day 4) versus standard administration (day 2) in expected poor, normal, and high responders undergoing controlled ovarian stimulation for IVF.","OBJECTIVE
To assess whether corifollitropin-α (CFα) late-start administration (day 4) and standard administration (day 2) can obtain similar oocyte yield and live birth rate.
STUDY DESIGN
A randomized controlled trial.
SETTING
University Hospital IVF Unit.
PATIENTS
One hundred thirteen women undergoing IVF.
INTERVENTIONS
Patients distributed in three subgroups (expected poor, normal, or high responders to FSH) were randomized into two treatment arms: (a) CFα late-start: CFα on day 4 + GnRH antagonist from day 8 + (when needed) recFSH from day 11; (b) CFα standard start: CFα on day 2 + GnRH antagonist from day 6 + (when needed) recFSH from day 9. IVF or ICSI was performed as indicated.
RESULTS
Considering the whole study group, the late-start regimen obtained comparable oocyte yield (8.9 ± 5.6 vs. 8.8 ± 6.2; p = n.s.), cPR/started cycle (25% vs. 31.6%, p = n.s.), and cumulative live birth rate (LBR)/ovum pickup (OPU) (29.2% vs. 37.7%, p = n.s.) than the standard regimen. The outcome of the two regimens was comparable in the two subgroups of high and normal responders. Differently, in poor responders, oocyte yield was similar, but LBR/OPU was significantly lower with late-start CFα administration that caused 40% cancellation rate due to monofollicular response. ROC curves showed that the threshold AMH levels associated with cycle cancellation were 0.6 ng/ml for late-start regimen and 0.2 ng/ml for standard regimen.
CONCLUSION
CFα may be administered on either day 2 or day 4 to patients with expected high or normal response to FSH without compromising oocyte yield and/or live birth rate. Differently, late-start administration is not advisable for expected poor responders with AMH ≤ 0.6 ng/ml.
TRIAL REGISTRATION
NCT03816670.",2020,The outcome of the two regimens was comparable in the two subgroups of high and normal responders.,"['One hundred thirteen women undergoing IVF', 'University Hospital IVF Unit']","['IVF or ICSI', 'corifollitropin-α late-start (day 4) versus standard administration', 'corifollitropin-α (CFα) late-start administration (day 4) and standard administration', 'CFα late-start: CFα on day 4 + GnRH antagonist from day 8 + (when needed) recFSH']","['oocyte yield', 'LBR/OPU', 'cumulative live birth rate (LBR)/ovum pickup (OPU', 'cPR/started cycle']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C1272689', 'cui_str': 'Started'}]",113.0,0.17166,The outcome of the two regimens was comparable in the two subgroups of high and normal responders.,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Revelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy. alberto.revelli@unito.it.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gennarelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sestero', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Canosa', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carosso', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Salvagno', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pittatore', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Filippini', 'Affiliation': 'Clinical Statistics, Department of Surgical Sciences, University of Torino, Corso Bramante 88, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Benedetto', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01742-5']
709,31567597,Pilot Study of an Integrated Smartphone and Breathalyzer Contingency Management Intervention for Alcohol Use.,"INTRODUCTION
Monitoring devices provide a platform for assessing alcohol use and implementing alcohol interventions. This pilot study focused on assessing the early-stage feasibility and usability of a smartphone-based application and breathalyzer used in a contingency management intervention for alcohol use.
METHODS
Six nontreatment-seeking participants completed a 9-week ABA within-subjects designed intervention targeting alcohol use. Participants submitted 2 to 8 alcohol breathalyzer samples per day and completed self-report drinking measures and usability assessments. During the A phases (weeks 1-3 and 8-9), participants received reinforces for submitting breathalyzer samples, regardless of their results. During the contingency management, B phase (weeks 4-7), and received reinforcers only when negative breathalyzer samples were submitted. Usability assessment of the application was also conducted during weeks 2 and 9.
RESULTS
Participants in the contingent B phase (49%) were more likely to submit alcohol-negative breathalyzer samples compared with the noncontingent A phases (27%; P < 0.001). Usability assessment of the application varied, and participants noted several technical concerns.
CONCLUSION
The use of smartphones and breathalyzers may be a practical solution to extend the reach of contingency management during and after treatment.",2020,"RESULTS
Participants in the contingent B phase (49%) were more likely to submit alcohol-negative breathalyzer samples compared with the noncontingent A phases (27%; P < 0.001).",['Six nontreatment-seeking participants completed a 9-week ABA within-subjects designed intervention targeting alcohol use'],"['smartphone-based application and breathalyzer', 'Integrated Smartphone and Breathalyzer Contingency Management Intervention']",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],,0.0178718,"RESULTS
Participants in the contingent B phase (49%) were more likely to submit alcohol-negative breathalyzer samples compared with the noncontingent A phases (27%; P < 0.001).","[{'ForeName': 'Oladunni', 'Initials': 'O', 'LastName': 'Oluwoye', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Spokane, WA (OO, HR, JH, KCA, MGM); Elson S. Floyd College of Medicine, Washington State University, Spokane, WA (OO, SM, JR, MGM); Program for Excellence in Addiction Research, Washington State University, Spokane, WA (OO, SM, JR, MGM); Providence Medical Research Center, Providence Health Care, Spokane, WA (SM).'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Reneau', 'Affiliation': ''}, {'ForeName': 'Jalene', 'Initials': 'J', 'LastName': 'Herron', 'Affiliation': ''}, {'ForeName': 'Karl C', 'Initials': 'KC', 'LastName': 'Alcover', 'Affiliation': ''}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roll', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McDonell', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000553']
710,31169794,Ischemic Preconditioning Maintains Performance on Two 5-km Time Trials in Hypoxia.,"PURPOSE
The ergogenic effect of ischemic preconditioning (IPC) on endurance exercise performed in hypoxia remains debated and has never been investigated with successive exercise bouts. Therefore, we evaluated if IPC would provide immediate or delayed effects during two 5-km cycling time trials (TT) separated by ~1 h in hypoxia.
METHODS
In a counterbalanced randomized crossover design, 13 healthy males (27.5 ± 3.6 yr) performed two maximal cycling 5-km TT separated by ~1 h of recovery (TT1 25 min and TT2 2 h post-IPC/SHAM), preceded by IPC (3 × 5 min occlusion 220 mm Hg/reperfusion 0 mm Hg, bilaterally on thighs) or SHAM (20 mm Hg) at normobaric hypoxia (fraction of inspired oxygen [FiO2] of 16%). Performance and physiological (i.e., oxyhemoglobin saturation, heart rate, blood lactate, and vastus lateralis oxygenation) parameters were recorded.
RESULTS
Time to complete (P = 0.011) 5-km TT and mean power output (P = 0.005) from TT1 to TT2 were worse in SHAM, but not in IPC (P = 0.381/P = 0.360, respectively). There were no differences in time, power output, or physiological variables during the two TT between IPC and SHAM. All muscle oxygenation indices differed (P < 0.001) during the IPC/SHAM with a greater deoxygenation in IPC. During the TT, there was a greater concentration of total hemoglobin in IPC than SHAM (P = 0.047) and greater total hemoglobin in TT1 than TT2. Further, the concentration of oxyhemoglobin was lower during TT2 than TT1 (P = 0.005).
CONCLUSION
In moderate hypoxia, IPC allowed maintaining a higher blood volume during a subsequent maximal exercise, mitigating the performance decrement between two consecutive cycling TT.",2019,All muscle oxygenation indices differed (P < 0.001) during the IPC/SHAM with a greater deoxygenation in IPC.,['thirteen healthy males (27.5 ± 3.6 years) performed'],"['two maximal cycling 5 km TTs separated by ~1 h of recovery (TT1 25 min and TT2 2 h post IPC/SHAM', 'ischemic preconditioning (IPC', 'IPC (3 × 5 min occlusion 220 mmHg/reperfusion 0 mmHg, bilaterally on thighs) or SHAM (20 mmHg) at normobaric hypoxia (inspired fraction of oxygen']","['time, power output or in physiological variables', 'concentration of total hemoglobin ([tHb]) in IPC', 'Performance and physiological (i.e., oxyhemoglobin saturation, heart rate, blood lactate, and Vastus Lateralis oxygenation) parameters', 'All muscle oxygenation indices', 'concentration of oxyhemoglobin ([O2Hb']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428648', 'cui_str': 'Inspired oxygen concentration (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1168591', 'cui_str': 'Oxyhaemoglobin'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index'}]",13.0,0.39158,All muscle oxygenation indices differed (P < 0.001) during the IPC/SHAM with a greater deoxygenation in IPC.,"[{'ForeName': 'Gustavo R', 'Initials': 'GR', 'LastName': 'da Mota', 'Affiliation': 'Human Performance and Sport Research Group, Department of Sport Sciences, Institute of Health Sciences, Federal University of Triangulo Mineiro, Uberaba, MG, BRAZIL.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Willis', 'Affiliation': 'Faculty of Biology and Medicine, Institute of Sport Sciences, University of Lausanne, Lausanne, SWITZERLAND.'}, {'ForeName': 'Nelson Dos Santos', 'Initials': 'NDS', 'LastName': 'Sobral', 'Affiliation': 'Faculty of Biology and Medicine, Institute of Sport Sciences, University of Lausanne, Lausanne, SWITZERLAND.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Borrani', 'Affiliation': 'Faculty of Biology and Medicine, Institute of Sport Sciences, University of Lausanne, Lausanne, SWITZERLAND.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Billaut', 'Affiliation': 'Department of Kinesiology, Laval University, Quebec, QC, CANADA.'}, {'ForeName': 'Grégoire P', 'Initials': 'GP', 'LastName': 'Millet', 'Affiliation': 'Faculty of Biology and Medicine, Institute of Sport Sciences, University of Lausanne, Lausanne, SWITZERLAND.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002049']
711,31169795,Dual-Task Walking Capacity Mediates Tai Ji Quan Impact on Physical and Cognitive Function.,"PURPOSE
Emerging evidence indicates exercise training improves mobility and cognition and reduces falls in older adults, but underlying mechanisms are not well understood. This study tested the hypothesis that change in dual-task walking capacity mediates the positive effect of Tai Ji Quan and multimodal exercise on physical performance, activity confidence, global cognition, and falls among community-dwelling older adults at high risk of falling.
METHODS
We conducted a secondary analysis of a 6-month randomized clinical trial comparing Tai Ji Quan: Moving for Better Balance (TJQMBB) and multimodal exercise to stretching exercise in a sample of 670 adults older than 70 yr who had a history of falls or impaired mobility. Distal outcome measures, ascertained at a 12-month follow-up, were the Short Physical Performance Battery, Activities-Specific Balance Confidence, Montreal Cognitive Assessment, and falls. The mediator hypothesized to account for the intervention effects was dual-task cost estimated by calculating changes in gait speed from single-task to dual-task walking from baseline to the end of intervention.
RESULTS
At 12 months, compared with stretching exercise, multimodal exercise significantly improved Short Physical Performance Battery and Activities-Specific Balance Confidence outcomes and reduced the number of falls (P < 0.05). However, it did not lower dual-task cost or mediate the intervention effects on distal outcomes. In contrast, TJQMBB significantly reduced dual-task cost relative to multimodal and stretching exercises (P < 0.05) which in turn resulted in improvements in lower-extremity physical performance, activity confidence, global cognitive function, and reductions in falls (P < 0.05) during follow-up.
CONCLUSIONS
Enhanced dual-task walking capacity as a result of Tai Ji Quan training mediated improvements in physical and cognitive outcomes in older adults at high risk of falling.",2019,"At 12 months, compared with stretching exercise, multimodal exercise significantly improved SPPB and ABC outcomes and reduced the number of falls (P < 0.05).","['community-dwelling older adults at high risk of falling', '670 older adults aged ≥70 years who had a history of falls or impaired mobility', 'older adults at high risk of falling', 'older adults']","['Tai Ji Quan and multimodal exercise', 'exercise training', 'Tai Ji Quan: Moving for Better Balance (TJQMBB) and multimodal exercise to stretching exercise', 'Tai Ji Quan training', 'stretching exercise, multimodal exercise', 'TJQMBB']","['mobility and cognition and reduces falls', 'dual-task cost relative to multimodal and stretching exercises', 'lower-extremity physical performance, activity confidence, global cognitive function, and reductions in falls', 'Physical and Cognitive Function', 'number of falls', 'SPPB and ABC outcomes', 'physical and cognitive outcomes', 'physical performance, activity confidence, global cognition, and falls', 'Short Physical Performance Battery (SPPB), Activities-Specific Balance Confidence (ABC), Montreal Cognitive Assessment (MoCA), and falls']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0518456', 'cui_str': 'Physical mobility impairment'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2607857'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C3496286'}]",670.0,0.0347925,"At 12 months, compared with stretching exercise, multimodal exercise significantly improved SPPB and ABC outcomes and reduced the number of falls (P < 0.05).","[{'ForeName': 'Fuzhong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Harmer', 'Affiliation': 'Department of Exercise and Health Science, Willamette University, Salem, OR.'}, {'ForeName': 'Li-Shan', 'Initials': 'LS', 'LastName': 'Chou', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002051']
712,30915676,Community-Based Cervical Cancer Education: Changes in Knowledge and Beliefs Among Vietnamese American Women.,"Low cervical cancer screening rates among Vietnamese American women have been attributed, in part, to inadequate knowledge about cervical cancer and health beliefs that hinder screening. A community-based educational program was developed to improve knowledge and attitudes toward cervical cancer screening in this underserved population. It was hypothesized that the program would result in increases in knowledge, as well as enhanced health beliefs and self-efficacy toward obtaining cervical cancer screening. Using a group-randomized design, 1488 women from 30 Vietnamese community-based organizations were assigned to either the intervention (n = 816) or control (n = 672) conditions. The intervention group received cervical cancer education delivered by bilingual community health educators. Intervention content addressed individual beliefs and expectancies regarding cervical cancer screening (e.g., perceived risk of developing cervical cancer; perceived benefits and barriers to screening; social and cultural norms regarding screening). The control group received general health education, including information about cancer screening. Knowledge and health beliefs were assessed at baseline and post-intervention. Among women in the intervention group, overall knowledge about cervical cancer and screening guidelines increased from pre- to post-program (30% vs. 88%, p < 0.001), perceived benefits of screening increased (3.50 vs. 4.49, p < 0.001), and perceived barriers to screening decreased (3.13 vs. 2.25, p < 0.001). Changes in knowledge and health beliefs were not observed among women in the control group. A community-based educational program can help increase knowledge about cervical cancer and screening, promote positive changes in women's beliefs about the benefits of cervical cancer screening, and reduce perceived barriers to screening. Such programs may play an important role in addressing health disparities and informing underserved populations about recommended screening tests.",2019,"Among women in the intervention group, overall knowledge about cervical cancer and screening guidelines increased from pre- to post-program (30% vs. 88%, p < 0.001), perceived benefits of screening increased (3.50 vs. 4.49, p < 0.001), and perceived barriers to screening decreased (3.13 vs. 2.25, p < 0.001).","['Vietnamese American Women', '1488 women from 30 Vietnamese community-based organizations', 'Vietnamese American women']","['general health education, including information about cancer screening', 'cervical cancer education delivered by bilingual community health educators']","['overall knowledge about cervical cancer and screening guidelines', 'health beliefs and self-efficacy', 'knowledge and attitudes toward cervical cancer screening', 'perceived benefits of screening', 'knowledge and health beliefs', 'Low cervical cancer screening rates', 'Knowledge and health beliefs']","[{'cui': 'C4505363', 'cui_str': 'Vietnamese Americans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1561452', 'cui_str': 'Vietnamese'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220885', 'cui_str': 'organization'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer (procedure)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",1488.0,0.0239889,"Among women in the intervention group, overall knowledge about cervical cancer and screening guidelines increased from pre- to post-program (30% vs. 88%, p < 0.001), perceived benefits of screening increased (3.50 vs. 4.49, p < 0.001), and perceived barriers to screening decreased (3.13 vs. 2.25, p < 0.001).","[{'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Fang', 'Affiliation': 'Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA, 19111, USA. carolyn.fang@fccc.edu.'}, {'ForeName': 'Minsun', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Ziding', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Biostatistics Program, The Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Fayola', 'Initials': 'F', 'LastName': 'Levine', 'Affiliation': 'Hunter College, New York, NY, USA.'}, {'ForeName': 'Cuc', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Asian Community Health Coalition, Philadelphia, PA, USA.'}, {'ForeName': 'Grace X', 'Initials': 'GX', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Sciences, Center for Asian Health, Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}]",Journal of community health,['10.1007/s10900-019-00645-6']
713,31318750,Fractionated Irradiation in Photobiomodulation Therapy of Ankle Sprain.,"OBJECTIVE
The aim of this study was to test whether fractionated irradiation in photobiomodulation therapy enhances short-term recovery in patients with moderate severity ankle sprain.
DESIGN
Nineteen patients were randomly assigned to one of two groups: one group receiving photobiomodulation therapy combined with the standard rest, icing, compression, and elevation treatment, or a group receiving only standard treatment. Group 1 patients were irradiated using a laser system (635 nm, 15 mW) according to a double-fractionated irradiation scheme consisting of two sessions (4.5 and 9 J/cm) separated by a 30-min time interval. Short-term outcomes (reflectance, pain, and clinical outcomes) were assessed at baseline, 10 days, and 6 wks after treatment.
RESULTS
Reflectance data analysis showed significant changes in group 1 (P = 0.027). There was also an ankle function score improvement more in group 1 than in group 2, with a significant short-term effect (P = 0.011) but without significant long-term effects (P = 0.178). Compared with group 2, group 1 had an immediate effect on pain reduction, but no long-term effect (P = 0.074).
CONCLUSIONS
Combined with standard treatment, fractionated irradiation photobiomodulation therapy has been shown to have favorable short-term effects on the recovery of patients with ankle sprains, but its long-term effects should be improved.",2019,"There was also an ankle function score improvement more in group 1 than in group 2, with a significant short-term effect (P = 0.011) but without significant long-term effects (P = 0.178).","['Nineteen patients', 'patients with ankle sprains', 'patients with moderate severity ankle sprain']","['photobiomodulation therapy combined with the standard rest, icing, compression, and elevation treatment, or a group receiving only standard treatment', 'fractionated irradiation', 'Fractionated Irradiation']","['Short-term outcomes (reflectance, pain, and clinical outcomes', 'ankle function score improvement', 'pain reduction']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0160087', 'cui_str': 'Ankle Sprains'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]","[{'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.112597,"There was also an ankle function score improvement more in group 1 than in group 2, with a significant short-term effect (P = 0.011) but without significant long-term effects (P = 0.178).","[{'ForeName': 'Mihaela Antonina', 'Initials': 'MA', 'LastName': 'Calin', 'Affiliation': 'From the National Institute of Research and Development for Optoelectronics - INOE 2000, Magurele, Romania (MAC, DM, RS); Carol Davila University of Medicine and Pharmacy, Bucharest, Romania (AB, AH, ASN); Emergency University Hospital, Bucharest, Romania (AB); National Institute for Infectious Diseases Prof Dr Matei Bals, Bucharest, Romania (AH); and National Institute of Rehabilitation, Physical Medicine and Balneoclimatology, Bucharest, Romania (ASN).'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Badila', 'Affiliation': ''}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Hristea', 'Affiliation': ''}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Manea', 'Affiliation': ''}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Savastru', 'Affiliation': ''}, {'ForeName': 'Adriana Sarah', 'Initials': 'AS', 'LastName': 'Nica', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001178']
714,32201918,Efficacy of body weight vs body surface area-based prednisolone regimen in nephrotic syndrome.,"BACKGROUND
Prednisolone dosing regimen based on body surface area (BSA) or body weight (BW) in managing uncomplicated nephrotic syndrome (NS) has been a matter of controversy.
METHODS
In this parallel-arm randomized clinical trial, 60 children with uncomplicated NS in relapse were randomized to receive either of two regimens. Children of BW cohort received prednisolone (2 mg/kg/day) till remission (or 6 weeks for first episode); followed by 1.5 mg/kg on alternate days for 4 weeks (or 6 weeks for first episode). Children randomized for BSA cohort received prednisolone (60 mg/m 2 /day) till remission (or 6 week for first episode); followed by 40 mg/m 2 on alternate days for 4 weeks (or 6 weeks for first episode). The primary endpoint was 6-month relapse-free survival in the intention-to-treat population (clinical trial registry of India CTRI/2015/03/005655).
RESULTS
The 6-month relapse-free survival rates were similar for both BSA cohort 73.33% (22/30) and BW cohort 70% (21/30) (p = 1, OR 0.19, 95% CI 0.07-0.52). Requirement of cumulative steroid to achieve initial remission (96.1 ± 57.8 vs 63.58 ± 40.2 mg/kg, p = 0.014) and over 6-month study period (104.34 ± 50.82 vs 73.88 ± 42.95 mg/kg, p = 0.015) were significantly higher in BSA cohort in comparison to BW cohort. However, time taken in achieving remission during enrolment episode in both BSA and BW groups was comparable (7 ± 1.7 vs 6.9 ± 1.4 days, p = 0.81). While both treatments were well tolerated, the number of adverse events was one and half times as common in the BSA group than BW group (37 vs. 22 events).
CONCLUSIONS
In treating children with uncomplicated NS, both BSA and BW regimens were equally effective in achieving initial remission and maintaining disease remission. Due to fewer adverse events and lesser cumulative steroid exposure with BW based regimen, it may be considered as better option over BSA regimen.
CLINICAL TRIAL REGISTRY NAME
Clinical Trial Registry of India (CTRI/2015/03/005655).",2020,"In treating children with uncomplicated NS, both BSA and BW regimens were equally effective in achieving initial remission and maintaining disease remission.","['nephrotic syndrome', '60 children with uncomplicated NS in relapse']","['body weight vs body surface area-based prednisolone regimen', 'Prednisolone', 'prednisolone']","['6-month relapse-free survival', 'initial remission', 'tolerated, the number of adverse events', 'initial remission and maintaining disease remission', '6-month relapse-free survival rates']","[{'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",60.0,0.109569,"In treating children with uncomplicated NS, both BSA and BW regimens were equally effective in achieving initial remission and maintaining disease remission.","[{'ForeName': 'Biswanath', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics, NRS Medical College and Hospital, Kolkata, West Bengal, 700014, India. basuv3000@gmail.com.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Pediatrics, NRS Medical College and Hospital, Kolkata, India.'}, {'ForeName': 'Shilpita', 'Initials': 'S', 'LastName': 'Barua', 'Affiliation': 'Department of Pediatrics, NRS Medical College and Hospital, Kolkata, India.'}, {'ForeName': 'Abhisek', 'Initials': 'A', 'LastName': 'Naskar', 'Affiliation': 'Department of Pediatrics, NRS Medical College and Hospital, Kolkata, India.'}, {'ForeName': 'Birendranath', 'Initials': 'B', 'LastName': 'Roy', 'Affiliation': 'Department of Pediatrics, NRS Medical College and Hospital, Kolkata, India.'}]",Clinical and experimental nephrology,['10.1007/s10157-020-01875-y']
715,32196856,A double-blind placebo-controlled randomized trial on the effect of hyosine n-butyl bromide for improving duration of labor in term pregnancies.,"AIM
To compare the effectiveness of intramuscular hyocine n-butyl bromide (HBB) with placebo for shortening the duration of the first stage of labor in term pregnancies.
METHODS
A double blind placebo-controlled randomized trial of parturients who presented at term in the active phase of labor was conducted. They were randomly (1:1 ratio) given intramuscular injection of either 40 mg (2 mL) of HBB or 2 mL of water for injection as a placebo. The primary outcome measures were the duration of first and second stages of labor. Subgroup analysis of primigravid and multigravid women were also performed for various outcomes. We did intention-to-treat analysis.
RESULTS
Sixty-two women were randomized to each group and none were lost to follow-up. Baseline characteristics were similar between the HBB and placebo groups. The mean duration of first stage of labor was noted to be significantly shorter in the HBB group for both the primigravidas (246.6 ± 21.9 vs 391.8 ± 56.6 min for control; P < 0.001) and for multigravidas (205.9 ± 17.8 vs 323.8 ± 16.0 min for control;P < 0.001).There was also significantly shorter duration of second stage of labor in the HBB group (primigravida: P = 0.013; multigravida: P = 0.016). The duration of third stage of labor, mode of delivery and maternal and/or neonatal outcomes for both classes of parturients were not significantly different.
CONCLUSION
HBB is effective in reducing the first and second stages of labor without adverse maternal or neonatal outcome. HBB does not significantly influence the duration of third stage of labor including mode of delivery. More evidence is needed to further explore the potential useful role of HBB in the active phase of labor.",2020,The mean duration of first stage of labor was noted to be significantly shorter in the HBB group for both the primigravidas (246.6 ± 21.9 vs 391.8 ± 56.6 min for control; P < 0.001) and for multigravidas (205.9 ± 17.8 vs 323.8 ± 16.0 min for control;P < 0.001).There was also significantly shorter duration of second stage of labor in the HBB group,"['parturients who presented at term in the active phase of labor was conducted', 'term pregnancies', 'Sixty-two women']","['placebo', 'HBB', 'hyosine n-butyl bromide', 'intramuscular hyocine n-butyl bromide (HBB) with placebo', 'HBB or 2\u2009mL of water for injection as a placebo']","['duration of third stage of labor including mode of delivery', 'duration of labor', 'mean duration of first stage of labor', 'duration of third stage of labor, mode of delivery and maternal and/or neonatal outcomes', 'duration of first and second stages of labor']","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy (finding)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0626372', 'cui_str': '1-bromobutane'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0474482', 'cui_str': 'Duration of third stage of labor (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0474469', 'cui_str': 'Duration of first stage of labor (observable entity)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}]",62.0,0.275122,The mean duration of first stage of labor was noted to be significantly shorter in the HBB group for both the primigravidas (246.6 ± 21.9 vs 391.8 ± 56.6 min for control; P < 0.001) and for multigravidas (205.9 ± 17.8 vs 323.8 ± 16.0 min for control;P < 0.001).There was also significantly shorter duration of second stage of labor in the HBB group,"[{'ForeName': 'Toochukwu Benjamin', 'Initials': 'TB', 'LastName': 'Ejikeme', 'Affiliation': 'Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'George Uchenna', 'Initials': 'GU', 'LastName': 'Eleje', 'Affiliation': 'Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'Gabriel O', 'Initials': 'GO', 'LastName': 'Igberase', 'Affiliation': 'Department of Obstetrics and Gynaecology, Delta State University, Abraka, Nigeria.'}, {'ForeName': 'Emmanuel Onyebuchi', 'Initials': 'EO', 'LastName': 'Ugwu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Nigeria Enugu Campus, Enugu, Nigeria.'}, {'ForeName': 'David Chibuike', 'Initials': 'DC', 'LastName': 'Ikwuka', 'Affiliation': 'Department of Human Physiology, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Boniface Chukwuneme', 'Initials': 'BC', 'LastName': 'Okpala', 'Affiliation': 'Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14251']
716,32193541,"Utility of major basic protein, eotaxin-3, and mast cell tryptase staining for prediction of response to topical steroid treatment in eosinophilic esophagitis: analysis of a randomized, double-blind, double dummy clinical trial.","Inflammatory factors in eosinophilic esophagitis (EoE), including major basic protein (MBP), eotaxin-3 (EOT3) and mast cell tryptase (TRP), may predict treatment response to topical corticosteroids (tCS). We aimed to determine whether baseline levels of these markers predict response to tCS for EoE. To do this, we analyzed data from a randomized trial comparing two topical steroids for treatment of newly diagnosed EoE (NCT02019758). A pretreatment esophageal biopsy was stained for MBP, EOT3, and TRP to quantify tissue biomarker levels (cells/mm2). Levels were compared between histologic responders (<15 eos/hpf) and nonresponders (the primary outcome), and endoscopic responders (EREFS<2) and nonresponders. Complete histologic response (<1 eos/hpf) was also assessed, and area under the receiver operator characteristic curve (AUC) was calculated. We also evaluated whether baseline staining predicted symptom relapse in the trial's off-treatment observation phase. Baseline samples were evaluable in 110/111 subjects who completed the randomized trial. MBP levels were higher in nonresponders (n = 36) than responders (704 vs. 373 cells/mm2; P = 0.007), but EOT3 and TRP levels were not statistically different. The combination of all three stains had an AUC of 0.66 to predict response. For complete histologic response, baseline TRP levels were higher in nonresponders (n = 69) than responders (370 vs. 268 mast cells/mm2; P = 0.01), with an AUC of 0.65. The AUC for endoscopic response was 0.68. Baseline staining did not predict symptom recurrence after remission. Pretreatment MBP, EOT3, and TRP levels were not strongly or consistently associated with histologic or endoscopic response to topical steroids. While elevated TRP levels may be associated with nonresponse compared with complete response, the magnitude and predictive utilities were modest. Novel methods for predicting steroid response are still required.",2020,"MBP levels were higher in nonresponders (n = 36) than responders (704 vs. 373 cells/mm2; P = 0.007), but EOT3 and TRP levels were not statistically different.","['eosinophilic esophagitis', 'Baseline samples were evaluable in 110/111 subjects who completed the randomized trial']","['major basic protein, eotaxin-3, and mast cell tryptase staining', 'topical steroids']","['MBP levels', 'major basic protein (MBP), eotaxin-3 (EOT3) and mast cell tryptase (TRP', 'elevated TRP levels', 'Complete histologic response', 'Pretreatment MBP, EOT3, and TRP levels', 'EOT3 and TRP levels', 'complete histologic response, baseline TRP levels']","[{'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4476471', 'cui_str': 'Chemokine CCL26'}, {'cui': 'C1704347', 'cui_str': 'Mast Cell Tryptase'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0662675', 'cui_str': '(18F)MBP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4476471', 'cui_str': 'Chemokine CCL26'}, {'cui': 'C1704347', 'cui_str': 'Mast Cell Tryptase'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}]",,0.426272,"MBP levels were higher in nonresponders (n = 36) than responders (704 vs. 373 cells/mm2; P = 0.007), but EOT3 and TRP levels were not statistically different.","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Woosley', 'Affiliation': 'Department of Pathology and Laboratory Medicine; University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'McGee', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Moist', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Shaheen', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}]",Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus,['10.1093/dote/doaa003']
717,32189094,"Delegating Clozapine Monitoring to Advanced Nurse Practitioners: An Exploratory, Randomized Study to Assess the Effect on Prescription and Its Safety.","To test whether: (1) psychiatrists will prescribe clozapine more often if they can delegate the monitoring tasks to an advanced nurse practitioner (ANP), (2) clozapine monitoring by an ANP is at least as safe as monitoring by a psychiatrist. Patients from 23 Dutch outpatient teams were assessed for an indication for clozapine. ANPs affiliated to these teams were randomized to Condition A: clozapine monitoring by an ANP, or Condition B: monitoring by the psychiatrist. The safety of monitoring was evaluated by determining whether the weekly neutrophil measurements were performed. Staff and patients were blinded regarding the first hypothesis. Of the 173 patients with an indication for clozapine at baseline, only seven in Condition A and four in Condition B were prescribed clozapine (Odds Ratio = 2.24, 95% CI 0.61-8.21; p = 0.225). These low figures affected the power of this study. When we considered all patients who started with clozapine over the 15-month period (N = 49), the Odds Ratio was 1.90 (95% CI 0.93-3.87; p = 0.078). With regard to the safety of the monitoring of the latter group of patients, 71.2% of the required neutrophil measurements were performed in condition A and 67.3% in condition B (OR = 0.98; CI = 0.16-3.04; p = 0.98). Identifying patients with an indication for clozapine does not automatically lead to improved prescription rates, even when an ANP is available for the monitoring. Clozapine-monitoring performed by an ANP seemed as safe as that by a psychiatrist.",2020,"Identifying patients with an indication for clozapine does not automatically lead to improved prescription rates, even when an ANP is available for the monitoring.","['Advanced Nurse Practitioners', '173 patients with an indication for', 'Patients from 23 Dutch outpatient teams']","['Clozapine', 'clozapine']",['prescription rates'],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0009079', 'cui_str': 'Clozapine'}]","[{'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",173.0,0.0393801,"Identifying patients with an indication for clozapine does not automatically lead to improved prescription rates, even when an ANP is available for the monitoring.","[{'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'van der Zalm', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands. y.vanderzalm@rivierduinen.nl.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Schulte', 'Affiliation': 'Dutch Clozapine Collaboration Group, Castricum, The Netherlands.'}, {'ForeName': 'J P A M', 'Initials': 'JPAM', 'LastName': 'Bogers', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Termorshuizen', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'M A G B', 'Initials': 'MAGB', 'LastName': 'van Piere', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands.'}, {'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Sommer', 'Affiliation': 'Department of Neuroscience and Department of Psychiatry, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Selten', 'Affiliation': 'Rivierduinen Institute for Mental Health, Leiden, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Administration and policy in mental health,['10.1007/s10488-020-01031-4']
718,31174215,"Including 60 mg Elemental Iron in a Multiple Micronutrient Supplement Blunts the Increase in Serum Zinc after 12 Weeks of Daily Supplementation in Predominantly Anemic, Nonpregnant Cambodian Women of Reproductive Age.","BACKGROUND
Multiple micronutrient (MMN) supplementation may result in interaction effects due to competing absorptive pathways of trace elements.
OBJECTIVES
The aim of this study was to investigate the effect of MMN supplementation with or without iron on serum zinc, selenium, and copper concentrations in Cambodian women.
METHODS
In a 2 × 2 factorial double-blind randomized 12-wk trial, predominantly anemic, nonpregnant women (aged 18-45 y) received daily 60 mg of iron (Fe; n = 201); 14 other micronutrients including zinc (15 mg), selenium (65 μg), and copper (2 mg), but no iron (MMN; n = 202); 60 mg iron plus MMN (Fe + MMN; n = 206); or a placebo (n = 200). Fasting morning blood was collected at baseline and 12 wk from women in 26 villages in Kampong Chhnang province. Serum zinc, selenium, and copper concentrations (secondary outcomes of the randomized controlled trial) were measured using inductively coupled plasma mass spectrometry. Generalized linear regression was used to estimate intervention effects [β coefficient (95% CI)] for Fe (with or without MMN) and MMN (with or without Fe) after testing for the presence of an Fe × MMN interaction.
RESULTS
A total of 760 women completed the trial. Zinc deficiency prevalence at baseline was 45% (inflammation-adjusted serum zinc <10.7 μmol/L). A significant Fe × MMN interaction (P = 0.02) was detected in the 2 × 2 analysis with serum zinc concentration as the outcome: the MMN group had a higher mean serum zinc concentration at 12 wk (12.3 μmol/L; 95% CI: 12.2, 12.4 μmol/L) compared with all other groups, and the Fe + MMN group had a higher mean serum zinc concentration (11.6 μmol/L; 95% CI: 11.5, 11.7 μmol/L) compared with the Fe group (11.0 μmol/L; 95% CI: 10.9, 11.0 μmol/L) and the placebo group (11.2 μmol/L; 95% CI: 11.1, 11.4 μmol/L).
CONCLUSIONS
The inclusion of 60 mg iron in the daily MMN formulation may be interfering with the absorption and/or metabolism of supplemental zinc in Cambodian women. This is of particular concern when MMN supplementation is implemented in populations with risk of zinc deficiency. This trial was registered at clinicaltrials.gov as NCT-02481375.",2019,Zinc deficiency prevalence at baseline was 45% (inflammation-adjusted serum zinc <10.7 μmol/L).,"['Cambodian women', 'populations with risk of zinc deficiency', '760 women completed the trial', 'predominantly anemic, nonpregnant women (aged 18-45 y']","['placebo', 'MMN supplementation', 'Fe (with or without MMN) and MMN', 'MMN', 'daily 60 mg of iron (Fe; n\xa0=\xa0201); 14 other micronutrients including zinc (15 mg), selenium (65 μg), and copper (2 mg), but no iron (MMN; n\xa0=\xa0202); 60 mg iron plus MMN (Fe\xa0+\xa0MMN']","['Fasting morning blood', 'serum zinc, selenium, and copper concentrations', 'mean serum zinc concentration', 'Serum Zinc', 'Serum zinc, selenium, and copper concentrations', 'Zinc deficiency prevalence']","[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency (disorder)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",760.0,0.747151,Zinc deficiency prevalence at baseline was 45% (inflammation-adjusted serum zinc <10.7 μmol/L).,"[{'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Holmes', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Hou', 'Initials': 'H', 'LastName': 'Kroeun', 'Affiliation': 'Helen Keller International, Phnom Penh, Cambodia.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Houghton', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Rosalind S', 'Initials': 'RS', 'LastName': 'Gibson', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kimberly B', 'Initials': 'KB', 'LastName': 'Harding', 'Affiliation': 'Nutrition International, Ottawa, Canada.'}, {'ForeName': 'Luz Maria', 'Initials': 'LM', 'LastName': 'De-Regil', 'Affiliation': 'Nutrition International, Ottawa, Canada.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kraemer', 'Affiliation': 'Sight and Life Foundation, Basel, Switzerland, and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Susan I', 'Initials': 'SI', 'LastName': 'Barr', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz097']
719,32124728,"Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study.","Four formulations of an investigational tetravalent dengue purified inactivated vaccine, administered as two doses one month (M) apart, were previously shown to be immunogenic and well-tolerated up to M13 of the phase I study NCT01702857. Here, we report results of the follow-up from M14 to year (Y) 3. One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed, were randomized 1:1:1:1:1 to receive placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01 E or AS03 B , or aluminum-adjuvanted 4 μg/serotype/dose. No serious adverse events occurred. Two medically-attended potential immune-mediated disease cases, vaccination unrelated, were reported (groups 1 µg+Alum and 1 µg+AS03 B ). Of 14 instances of suspected dengue, none were laboratory confirmed. Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3). All formulations appeared to be safe and immunogenic during the 3-year follow-up.",2020,"Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3).","['One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed', 'Healthy Adults from Puerto Rico']","['placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01 E or AS03 B , or aluminum-adjuvanted 4-μg /serotype/dose', 'Tetravalent Dengue Purified Inactivated Vaccine', 'Placebo']",['Safety and Immunogenicity'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011315', 'cui_str': 'Breakbone Fever Virus'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202311', 'cui_str': 'Aluminum measurement (procedure)'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.0919901,"Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3).","[{'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Diaz', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Luis J', 'Initials': 'LJ', 'LastName': 'Martinez', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lepine', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Vaughn', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Wilson', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Paris', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0461']
720,32172314,Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study.,"PURPOSE
Drainage is a common procedure in high tibial osteotomy (HTO), but the benefits of drainage during HTO remain poorly investigated. This study was designed to investigate the effect of drainage on blood loss and early functional recovery in HTO.
METHODS
Altogether, 80 patients undergoing HTO were analyzed from August 2018 to September 2019. Patients were randomized into two groups: group A (drainage, n = 40) and group B (no drainage, n = 40). There were no intergroup differences in baseline parameters between the two groups, and the same surgical techniques and haemostatic methods were used. The mean follow-up time was 3.2 months. Blood loss and early functional recovery of the knee were examined post-operatively in both groups.
RESULTS
The total post-operative blood loss was 253.34 ± 104.18 ml in group A and 222.51 ± 106.89 ml in group B. This difference was non-significant (p > 0.05). The post-operative haemoglobin and haematocrit differences between groups were also non-significant (p > 0.05). Post-operative visual analogue scale (VAS) pain scores and lower leg swelling were lower in group A than those in group B (p < 0.05), and the early range of motion of the knee joint was higher in group A than that in group B (p < 0.05). Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05). The differences in three month post-operative VAS and knee function scores were non-significant (p > 0.05).
CONCLUSION
Drainage in HTO does not increase patients' total blood loss, but it can promote early knee function recovery by reducing post-operative pain, lower leg swelling, and the incidence of incision complications.
TRIAL REGISTRATION
NCT-03954860.",2020,Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05).,"['high tibial osteotomy (HTO', 'high tibial osteotomy', '80 patients undergoing HTO were analyzed from August 2018 to September 2019']",[],"['operative VAS and knee function scores', 'Post-operative visual analogue scale (VAS) pain scores and lower leg swelling', 'early range of motion of the knee joint', 'total blood loss', 'blood loss and early functional recovery', 'incidence rates of dressing seepage and incision complications', 'Drainage relieves pain', 'total post-operative blood loss', 'Blood loss and early functional recovery of the knee']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",80.0,0.0708681,Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05).,"[{'ForeName': 'Songlin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Laoling Hospital of traditional Chinese Medicine, Dezhou, Shandong, China.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Watson', 'Affiliation': 'Shandong University Cheeloo College of Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Qunshan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Desu', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Peilai', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China. 15634057227@163.com.'}]",International orthopaedics,['10.1007/s00264-020-04530-z']
721,32163323,Examining the Causal Effects of Sleep Deprivation on Emotion Regulation and Its Neural Mechanisms.,"Cognitive reappraisal (CR) is a strategy used to regulate emotions that is thought to be effective but effortful, relying on higher-order cognitive control systems to engage in active regulation. Sleep deprivation is believed to impair the functioning of these control systems, suggesting that it may impede the ability to implement CR effectively. This study tested the causal effects of sleep deprivation on emotional reactivity and the neurobiological systems underlying CR. We employed a within-subject crossover design in which participants underwent fMRI scanning twice, once when fully rested and once after a night of total sleep deprivation. During scans, participants passively viewed or used CR to down-regulate their emotional response to negative and neutral images. Contrary to hypotheses, both self-reported negative affect ratings and neural responses to the images indicated no difference in the way participants implemented CR when sleep deprived and when fully rested. Meanwhile, neural regions that showed distinct reactivity responses to negative relative to neutral images lost this specificity under deprived conditions. Negative affect ratings and heart rate deceleration, a physiological response typically evoked by aversive pictures, exhibited a similar blunting. Together, these results suggest that, although sleep deprivation may reduce the discrimination between emotional reactivity responses to negative and neutral stimuli, it does not impact CR the way it is presently studied.",2020,"Negative affect ratings and heart rate deceleration, a physiological response typically evoked by aversive pictures, exhibited a similar blunting.",[],"['Cognitive reappraisal (CR', 'fMRI scanning']",['Negative affect ratings and heart rate deceleration'],[],"[{'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}]",,0.0247213,"Negative affect ratings and heart rate deceleration, a physiological response typically evoked by aversive pictures, exhibited a similar blunting.","[{'ForeName': 'Maheen', 'Initials': 'M', 'LastName': 'Shermohammed', 'Affiliation': 'Harvard University.'}, {'ForeName': 'Laurel E', 'Initials': 'LE', 'LastName': 'Kordyban', 'Affiliation': 'Harvard University.'}, {'ForeName': 'Leah H', 'Initials': 'LH', 'LastName': 'Somerville', 'Affiliation': 'Harvard University.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01555']
722,31318743,Could the Clinical Effectiveness Be Improved Under the Integration of Orthotic Intervention and Scoliosis-Specific Exercise in Managing Adolescent Idiopathic Scoliosis?: A Randomized Controlled Trial Study.,"OBJECTIVE
The aim of the study was to compare the effectiveness of the integration of orthotic intervention and scoliosis-specific exercise with orthotic intervention only via assessing the spinal deformity, back muscle endurance, and pulmonary function of the patients with adolescent idiopathic scoliosis.
DESIGN
It is a prospective randomized controlled study. Patients who fulfilled the SRS criteria for orthotic intervention were randomly assigned to the orthosis combined with exercise group (combined orthotic and exercise intervention) or the orthotic intervention group (orthotic intervention only). All the subjects were prescribed with a rigid thoracolumbosacral orthosis and scoliosis-specific exercise program was provided to the subjects in the orthosis combined with exercise group. Cobb angle, back muscle endurance, and pulmonary function of subjects were measured at baseline, 1-mo, and 6-mo follow-up visits.
RESULTS
After 6 mos of intervention, the subjects in the orthosis combined with exercise group showed better Cobb angle correction than those in the orthotic intervention group. The back muscle endurance and pulmonary function decreased in the subjects of the orthotic intervention group, whereas some improvement happened in the subjects of the orthosis combined with exercise group. Between-group statistical significance was detected at the 6-mo follow-up among back muscle endurance time and parameters of pulmonary function.
CONCLUSIONS
In this study, orthotic intervention combined with scoliosis-specific exercise offered better Cobb angle correction and improvement of the respiratory parameters and back muscle endurance of the patients with adolescent idiopathic scoliosis as compared with orthotic intervention only.",2019,"Between-group statistical significance was detected at the 6-mo follow-up among back muscle endurance time and parameters of pulmonary function.
","['Patients who fulfilled the SRS criteria for orthotic intervention', 'patients with adolescent idiopathic scoliosis']","['orthotic intervention combined with scoliosis-specific exercise', 'orthotic intervention and scoliosis-specific exercise with orthotic intervention', 'Orthotic Intervention and Scoliosis-Specific Exercise', 'orthosis combined with exercise group (combined orthotic and exercise intervention) or the orthotic intervention group (orthotic intervention only', 'orthotic intervention', 'rigid thoracolumbosacral orthosis and scoliosis-specific exercise program']","['Cobb angle, back muscle endurance, and pulmonary function of subjects', 'Cobb angle correction', 'back muscle endurance and pulmonary function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis (disorder)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0563192', 'cui_str': 'Cobb angle (observable entity)'}, {'cui': 'C0224334', 'cui_str': 'Back Muscles'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",,0.0224633,"Between-group statistical significance was detected at the 6-mo follow-up among back muscle endurance time and parameters of pulmonary function.
","[{'ForeName': 'Chengfei', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'From the Center of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China (CG, CH); Department of Biomedical Engineering, The Hong Kong Polytechnic University, Hong Kong, China (CG, MW); Institute for Disaster Management and Reconstruction, Sichuan University-The Hong Kong Polytechnic University, Chengdu, Sichuan Province, China (CG, CH, MW); Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China (YZ); and Department of Rehabilitation Medicine, Wuxi Rehabilitation Hospital, Wuxi, Jiangsu Province, China (CG, YZ, CF, YY, MW).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Chunjiang', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Chengqi', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Mansang', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001160']
723,31318745,Unilateral Strength Training and Mirror Therapy in Patients With Chronic Stroke: A Pilot Randomized Trial.,"OBJECTIVE
The aim of the study was to investigate the feasibility and potential effectiveness of mirror-aided cross-education compared with cross-education alone in poststroke upper limb recovery.
DESIGN
A pilot randomized controlled parallel group study was carried out. Thirty-two patients with chronic stroke followed a 4-wk isometric strength training program performed with the less-affected upper limb three times per week. Participants in the mirror and strength training group observed the reflection of the exercising arm in the mirror. Participants in the strength training only group exercised without a mirror entirely. Participant compliance, adverse effects, and suitability of outcome measures assessed feasibility. Effectiveness outcomes included maximal isometric strength measured with the Biodex Dynamometer, the Modified Ashworth Scale, and the Chedoke Arm and Hand Activity Inventory.
RESULTS
Compliance was high with no adverse effects. The use of the Biodex Dynamometer must be reviewed. Mirror therapy did not augment the cross-education effect (P > 0.05) in patients with chronic stroke when training isometrically.
CONCLUSIONS
This pilot trial established the feasibility of a randomized controlled trial comparing mirror-aided cross-education with cross-education alone for poststroke upper limb recovery. Mirror therapy did not augment cross-education when training isometrically. However, results indicate that the combination of interventions should be investigated further applying an altered training protocol.",2019,"Mirror therapy did not augment the cross-education effect (P > 0.05) in patients with chronic stroke when training isometrically.
","['Thirty-two patients with chronic stroke', 'patients with chronic stroke', 'Patients With Chronic Stroke']","['mirror-aided cross-education compared with cross-education alone', 'strength training only group exercised without a mirror entirely', 'Mirror therapy', 'mirror and strength training', 'mirror-aided cross-education with cross-education alone', '4-wk isometric strength training program', 'Unilateral Strength Training and Mirror Therapy']","['maximal isometric strength measured with the Biodex Dynamometer, the Modified Ashworth Scale, and the Chedoke Arm and Hand Activity Inventory', 'cross-education effect']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",32.0,0.0363594,"Mirror therapy did not augment the cross-education effect (P > 0.05) in patients with chronic stroke when training isometrically.
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Ehrensberger', 'Affiliation': 'From the Clinical Health & Nutrition Centre (CHANCE), Department of Life Sciences, Institute of Technology, Sligo, Ireland (ME, DS, PB, KM); Physiotherapy & Population Science, University College Dublin, Dublin, Ireland (CB); Faculty of Medicine & Health Sciences, Royal College of Surgeons Ireland, Dublin, Ireland (FH); and University Hospital, Sligo, Ireland (PH, JO).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Broderick', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Blake', 'Affiliation': ''}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Horgan', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Hickey', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'OʼReilly', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Monaghan', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001162']
724,31318748,Randomized Trial on Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Dry Needling in Myofascial Trigger Points.,"OBJECTIVE
The aim of the study was to compare the efficacy of radial extracorporeal shock wave therapy and dry needling in the treatment of myofascial trigger points in the upper trapezius muscle.
DESIGN
A total of 65 patients with myofascial trigger points were randomly divided into extracorporeal shock wave therapy group (n = 32) and dry needling group (n = 33). Patients received 3 wks of treatment at 1-wk intervals (in both groups). Visual analog scale, pressure pain threshold, Neck Disability Index, and shear modulus were evaluated before treatment, immediately after the first therapy, 1 mo, and 3 mos after the completion of the third therapy.
RESULTS
Significant improvements of visual analog scale, pressure pain threshold, and Neck Disability Index scores were observed at all time points after treatment (P < 0.01) in both treatment groups. The shear modulus of myofascial trigger points was reduced in both dry needling group (P < 0.05) and extracorporeal shock wave therapy group (P < 0.01) immediately after the first treatment. Significant reductions in shear modulus were maintained up to 3-mo posttreatment in both groups (P < 0.01). There were no significant differences between the radial extracorporeal shock wave therapy group and dry needling group.
CONCLUSIONS
The extracorporeal shock wave therapy is as effective as dry needling for relieving pain, improving function, and reducing shear modulus for patients with myofascial trigger points after a series of three treatments.",2019,The shear modulus of myofascial trigger points was reduced in both dry needling group (P < 0.05) and extracorporeal shock wave therapy group (P < 0.01) immediately after the first treatment.,['65 patients with myofascial trigger points'],"['dry needling group', 'radial extracorporeal shock wave therapy and dry needling', 'Extracorporeal Shock Wave Therapy and Dry Needling', 'extracorporeal shock wave therapy']","['visual analog scale, pressure pain threshold, and Neck Disability Index scores', 'Visual analog scale, pressure pain threshold, Neck Disability Index, and shear modulus', 'shear modulus', 'shear modulus of myofascial trigger points']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}]","[{'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}]",65.0,0.0211911,The shear modulus of myofascial trigger points was reduced in both dry needling group (P < 0.05) and extracorporeal shock wave therapy group (P < 0.01) immediately after the first treatment.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Luan', 'Affiliation': ""From the Department of Rehabilitation Medicine, Guangdong Second Provincial General Hospital, Southern Medical University, Guangzhou, People's Republic of China (SL); Department of Rehabilitation Medicine, Lianjiang People's Hospital, Guangdong, People's Republic of China (ZZ); Department of Rehabilitation, Sun Yat-Sen Memorial Hospital, Guangzhou, People's Republic of China (SL, C. Lin, SK, C. Liu, SW, CM); Department of Ultrasonic, Sun Yat-Sen Memorial Hospital, Guangzhou, People's Republic of China (JR); and Zhongshan School of Medicine, Sun Yat-Sen University, Guangzhou, People's Republic of China (WX).""}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Jing-Liang', 'Initials': 'JL', 'LastName': 'Ruan', 'Affiliation': ''}, {'ForeName': 'Cai-Na', 'Initials': 'CN', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Song-Jian', 'Initials': 'SJ', 'LastName': 'Ke', 'Affiliation': ''}, {'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Xin', 'Affiliation': ''}, {'ForeName': 'Cui-Cui', 'Initials': 'CC', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Shao-Ling', 'Initials': 'SL', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001173']
725,32162501,Effects of strength vs. endurance training and their combination on physical performance characteristics in female horseback riders.,"BACKGROUND
The purpose of this study was to investigate effects of strength (S), endurance (E) and concurrent strength and endurance (SE) training on neuromuscular and cardiorespiratory characteristics during the 12-week volume-equated protocols in female horseback riders.
METHODS
Subjects (N.=44) (29.4±8.9 yrs) were assigned to S (N.=11), E (N.=11), SE (N.=13) and control (C) (N.=9) groups. Training consisted of progressive S, E or SE training 3x/week and riding exercise 4-6x/week. The measurements included maximal isometric bilateral leg press force (MVCLP) and EMG of VL and BF muscles, rapid isometric force production (0-500ms), maximal force of trunk extensor/flexors (MVCE/MVCF), countermovement-jump (CMJ), maximal oxygen uptake (VO2max), cycling-time (Timemax), blood lactate (L) and heart rate (HR) in the bicycle-ergometer test.
RESULTS
Only group S showed significant increases of 9% in MVCLP (P<0.01) and 3% in MVCE (P<0.05) forces. None of the groups showed significant increases in CMJ, rapid isometric force production or EMG. Timemax in the ergometer test increased significantly in S (P<0.05), SE (P<0.05) and E (P<0.01) with significant increases in VO2max in E (P<0.05) and SE (P<0.01).
CONCLUSIONS
The present strength-training program led to the significant gain in maximal strength in S but not in SE, maybe due to some interference effects produced by the actual endurance training and riding related endurance training. All groups increased significantly Timemax but VO2max increased only in E and SE. It would be useful for female horseback riders to perform combined SE training and to perform S training periodically to insure gains in strength, when needed.",2020,"Timemax in the ergometer test increased significantly in S (p<0.05), SE (p<0.05) and E (p<0.01) with significant increases in VO2max in E (p<0.05) and SE (p<0.01).
","['Subjects (N=44) (29.4±8.9 yrs) were assigned to S (n=11), E (n=11), SE (n=13) and control (C) (n=9) groups', 'female horseback riders']","['strength vs. endurance training', 'MVCLP', 'progressive S, E or SE training 3x/week and riding exercise 4-6x/week', 'strength (S), endurance (E) and concurrent strength and endurance (SE) training']","['physical performance characteristics', 'CMJ, rapid isometric force production or EMG', 'VO2max in E (p<0.05) and SE (p<0.01', 'maximal isometric bilateral leg press force (MVCLP) and EMG of VL and BF muscles, rapid isometric force production (0-500ms), maximal force of trunk extensor/flexors (MVCE/MVCF), countermovement-jump (CMJ), maximal oxygen uptake (VO2max), cycling-time (Timemax), blood lactate (L) and heart rate (HR) in the bicycle- ergometer test', 'Timemax but VO2max']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C2607857'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer, device (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0119964,"Timemax in the ergometer test increased significantly in S (p<0.05), SE (p<0.05) and E (p<0.01) with significant increases in VO2max in E (p<0.05) and SE (p<0.01).
","[{'ForeName': 'Anne-Maarit', 'Initials': 'AM', 'LastName': 'Hyttinen', 'Affiliation': 'Neuromuscular Research Center, Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland - anne.a-m.hyttinen@jyu.fi.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'Neuromuscular Research Center, Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10380-3']
726,32134956,Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy.,"HIV disproportionately affects men who have sex with men (MSM) and transgender women (TW). These populations use alcohol more heavily than the general population, and alcohol use disorders (AUDs) are more prevalent among them. Naltrexone (NTX) has documented efficacy and safety as a medication-assisted therapy for AUD. Its use has not been well-examined in persons with HIV (PWH) newly initiating antiretroviral therapy (ART) where the possibility of hepatotoxicity may be increased when initating multiple new medications. This study assessed the safety of oral NTX treatment (50 mg daily) initiated concomitantly with antiretroviral therapy (ART) in a double-blind randomized placebo-controlled trial of NTX in MSM/TW in Lima, Peru among MSM and TW with AUD (AUDIT score ≥ 8). We analyzed adverse event data from ART-naïve participants (N = 155) who were randomized (2:1) to initiate ART plus NTX (N = 103) or ART plus placebo (N = 52). Participants were monitored for 24 weeks while taking ART plus NTX/placebo, followed by 24 weeks receiving ART alone. Over 48 weeks, 135 grade 2 or 3 adverse events were reported, resulting in 1.3 clinical adverse events per participant equally represented in both treatment and placebo arms. Two serious adverse events occurred among two participants receiving NTX; neither was attributed to the study medication. No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points. These results suggest NTX is safe in MSM/TW PWH with AUD newly initiating ART, as no excess of clinical adverse events or transaminase elevation was associated with NTX use.",2020,No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points.,"['HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy', 'persons with HIV (PWH) newly initiating antiretroviral therapy (ART', 'HIV disproportionately affects men who have sex with men (MSM) and transgender women (TW', 'ART-naïve participants (N = 155) who were randomized (2:1) to']","['oral naltrexone', 'NTX', 'placebo', 'ART plus placebo', 'initiate ART plus NTX', 'Naltrexone (NTX', 'ART plus NTX/placebo', 'oral NTX treatment (50 mg daily) initiated concomitantly with antiretroviral therapy (ART']","['proportion of subjects reporting any adverse events', 'adverse events']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",155.0,0.257235,No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points.,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Grieco', 'Affiliation': 'University of Illinois at Chicago, School of Public Health, Chicago, IL, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'White', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Ding', 'Affiliation': 'University of Washington, School of Medicine, Seattle, WA, United States of America.'}, {'ForeName': 'Rachel Bender', 'Initials': 'RB', 'LastName': 'Ignacio', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Pinto-Santini', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Altice', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Duerr', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}]",PloS one,['10.1371/journal.pone.0228433']
727,32193624,Use of a Discharge Educational Strategy Versus Standard Discharge Care on Reduction of Vascular Risk in Patients with Stroke and Transient Ischemic Attack.,"PURPOSE OF THE REVIEW
The burden of ischemic stroke is disproportionally distributed between ethnic and racial subgroups in the USA, minority populations with lower socioeconomic status being at higher risk. These discrepancies are mirrored in susceptibility, primary care, and post-discharge procedures. Post-discharge strategies are of particular importance as their primary goal is to prevent recurrent stroke, which makes up about 25% of stroke cases per year in US. As disadvantaged minorities have faster growing populations, recurrent stroke poses a significant challenge not only for caretakers but also for the health care system as the whole. A number of educational strategies were employed to inform the general public of major symptoms, risk factors, and preventive measures for recurrent stroke. However, over affected subgroups did not prove responsive to such measures as these did not conform to their cultural and sociological specificities.
RECENT FINDINGS
The Discharge Educational Strategies for Reduction of Vascular Events Intervention (DESERVE) is a randomized control trial with a one year follow up, set out to investigate the possibility that culturally tailored, community-centered post-discharge strategies would improve compliance to therapy and prevention against secondary stroke. The trial targeted African Americans, Hispanic, and non-Hispanic whites, adapting discharge strategies for each individual group. DESERVE accomplished a significant reduction in blood pressure in the Hispanic intervention group by 9.9 mm Hg compared with usual care. The remaining two groups were not susceptible to these measures. DESERVE holds promise for culturally tailored interventions in the future in a battle against stroke and other chronic diseases.",2020,The remaining two groups were not susceptible to these measures.,"['Patients with Stroke and Transient Ischemic Attack', 'African Americans, Hispanic, and non-Hispanic whites, adapting discharge strategies for each individual group']",['Discharge Educational Strategy Versus Standard Discharge Care'],"['blood pressure', 'burden of ischemic stroke', 'Vascular Risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0205169,The remaining two groups were not susceptible to these measures.,"[{'ForeName': 'Anantha R', 'Initials': 'AR', 'LastName': 'Vellipuram', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA. anantha-ramana.vellipuram@ttuhsc.edu.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Hussain', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Rawla', 'Affiliation': 'Department of Internal Medicine/Hospitalist, Sovah Health, Martinsville, VA, 24112, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Maud', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Cruz-Flores', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}]",Current cardiology reports,['10.1007/s11886-020-01283-4']
728,31765604,Combination Therapy with Oral Treprostinil for Pulmonary Arterial Hypertension. A Double-Blind Placebo-controlled Clinical Trial.,"Rationale: Oral treprostinil improves exercise capacity in patients with pulmonary arterial hypertension (PAH), but the effect on clinical outcomes was unknown. Objectives: To evaluate the effect of oral treprostinil compared with placebo on time to first adjudicated clinical worsening event in participants with PAH who recently began approved oral monotherapy. Methods: In this event-driven, double-blind study, we randomly allocated 690 participants (1:1 ratio) with PAH to receive placebo or oral treprostinil extended-release tablets three times daily. Eligible participants were using approved oral monotherapy for over 30 days before randomization and had a 6-minute-walk distance 150 m or greater. The primary endpoint was the time to first adjudicated clinical worsening event: death; hospitalization due to worsening PAH; initiation of inhaled or parenteral prostacyclin therapy; disease progression; or unsatisfactory long-term clinical response. Measurements and Main Results: Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio, 0.74; 95% confidence interval, 0.56-0.97; P = 0.028). Key measures of disease status, including functional class, Borg dyspnea score, and N-terminal pro-brain natriuretic peptide, all favored oral treprostinil treatment at Week 24 and beyond. A noninvasive risk stratification analysis demonstrated that oral treprostinil-assigned participants had a substantially higher mortality risk at baseline but achieved a lower risk profile from Study Weeks 12-60. The most common adverse events in the oral treprostinil group were headache, diarrhea, flushing, nausea, and vomiting. Conclusions: In participants with PAH, addition of oral treprostinil to approved oral monotherapy reduced the risk of clinical worsening.Clinical trial registered with www.clinicaltrials.gov (NCT01560624).",2020,"RESULTS
Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio 0.74; 95% confidence interval [CI], 0.56 to 0.97;","['690 participants (1:1 ratio) with PAH to receive', 'participants with PAH who recently began approved oral monotherapy', 'Pulmonary Arterial Hypertension', 'patients with pulmonary arterial hypertension (PAH', 'Eligible participants were using approved oral monotherapy for >30 days prior to randomization and had a 6-minute walk distance ≥150 m']","['Placebo', 'placebo or oral treprostinil', 'treprostinil', 'Oral Treprostinil', 'placebo', 'oral treprostinil']","['risk of clinical worsening', 'time to first adjudicated clinical worsening event: death, hospitalization due to worsening PAH, initiation of inhaled or parenteral prostacyclin therapy, disease progression, or unsatisfactory long-term clinical response', 'Clinical worsening', 'exercise capacity', 'disease status, including functional class, Borg dyspnea score, and N-terminal-pro-brain natriuretic peptide', 'headache, diarrhea, flushing, nausea, and vomiting', 'mortality risk']","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1145760', 'cui_str': 'Treprostinil'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0205911', 'cui_str': 'Prostaglandins I'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",690.0,0.763053,"RESULTS
Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio 0.74; 95% confidence interval [CI], 0.56 to 0.97;","[{'ForeName': 'R James', 'Initials': 'RJ', 'LastName': 'White', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and the Mary M. Parkes Center, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Jerjes-Sanchez', 'Affiliation': 'Unidad de Investigación Clínica en Medicina, Monterrey, Mexico.'}, {'ForeName': 'Gisela Martina', 'Initials': 'GM', 'LastName': 'Bohns Meyer', 'Affiliation': 'Complexo Hospitalar Santa Casa de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Pulido', 'Affiliation': 'Departamento de Cardioneumología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Sepulveda', 'Affiliation': 'Pontifica Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Kuo Yang', 'Initials': 'KY', 'LastName': 'Wang', 'Affiliation': 'Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Ekkehard', 'Initials': 'E', 'LastName': 'Grünig', 'Affiliation': 'Thoraxclinic at University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Shirish', 'Initials': 'S', 'LastName': 'Hiremath', 'Affiliation': 'Ruby Hall Clinic, Grant Medical Foundation, Pune, India.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Gangcheng', 'Affiliation': 'Wuhan Asia Heart Hospital, Wuhan Shi, China.'}, {'ForeName': 'Wei Luen James', 'Initials': 'WLJ', 'LastName': 'Yip', 'Affiliation': 'Department of Cardiology, National University Heart Centre, Singapore, Singapore.'}, {'ForeName': 'Shuyang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'C Q', 'Initials': 'CQ', 'LastName': 'Deng', 'Affiliation': 'United Therapeutics, Research Triangle Park, North Carolina; and.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Grover', 'Affiliation': 'United Therapeutics, Research Triangle Park, North Carolina; and.'}, {'ForeName': 'Victor F', 'Initials': 'VF', 'LastName': 'Tapson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201908-1640OC']
729,32189116,"Correction to: Surgeon-delivered laparoscopic transversus abdominis plane blocks are non-inferior to anesthesia-delivered ultrasound-guided transversus abdominis plane blocks: a blinded, randomized non-inferiority trial.",The following text should have been included in the Acknowledgments.,2020,The following text should have been included in the Acknowledgments.,[],"['Surgeon-delivered laparoscopic transversus abdominis plane blocks', 'anesthesia-delivered ultrasound-guided transversus abdominis plane blocks']",[],[],"[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]",[],,0.253585,The following text should have been included in the Acknowledgments.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wong', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Curran', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Vitaliy Y', 'Initials': 'VY', 'LastName': 'Poylin', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Cataldo', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA. Tcatald1@bidmc.harvard.edu.'}]",Surgical endoscopy,['10.1007/s00464-020-07505-8']
730,32184082,"Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction.","PURPOSE
To evaluate safety and clinical response of Low-intensity Shockwave Therapy (Li-SWT) for the treatment of erectile dysfunction.
MATERIALS & METHODS
A single-institution, 2 arm, phase II randomized clinical trial was conducted between February 2017 and April 2019. Patients were randomized into 2 groups, with Li-SWT delivering a total of 3,600 shocks over 5 days (720 once a day, Group A) or over 2 weeks (600 once a day, 3 times a week, Group B). Patients were evaluated for the safety of therapy and completed the International Index of Erectile Function-Erectile Function domain and the Erectile Hardness Scale assessment at baseline, and at 1, 3, and 6 months visits.
RESULTS
Among 87 evaluable patients, 45 and 42 were allocated to Groups A and B treatment schedules, respectively, and 80 patients (40 per group) completed the 6-month evaluation. No adverse events were reported during treatment or during follow-up. There were statistically significant (P < .05) improvements in International Index of Erectile Function-Erectile Function score (mean increase of 2.7 [95% CI = 1.2, 4.2] and 2.7 points [95% CI = 1.4, 4.1] for Groups A and B, respectively) and in Erectile Hardness Scale (mean increase of 0.6 points (95% CI = 0.3, 0.8) and 0.5 (95% CI = 0.2, 0.8) for Groups A and B, respectively) at 6 months, with no differences between groups.
CONCLUSION
No difference in outcomes was found when Li-SWT 3,600 shocks were delivered over 1 or 2 weeks at 6 months follow-up and both schedules were safe with no adverse events during or after treatment. Further trials with longer follow-up and sham arm will provide valuable information regarding treatment efficacy and durability. Patel P, Katz J, Lokeshwar SD, et al. Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction. Sex Med 2020;8:214-222.",2020,"There were statistically significant (P < .05) improvements in International Index of Erectile Function-Erectile Function score (mean increase of 2.7 [95% CI = 1.2, 4.2] and 2.7 points [95% CI = 1.4, 4.1] for Groups A and B, respectively) and in Erectile Hardness Scale (mean increase of 0.6 points (95% CI = 0.3, 0.8) and 0.5 (95% CI = 0.2, 0.8) for Groups A and B, respectively) at 6 months, with no differences between groups.
","['87 evaluable patients, 45 and 42', 'Erectile Dysfunction']","['Li-SWT', 'Low-intensity Shockwave Therapy (Li-SWT', 'Low-Intensity Shockwave Therapy']","['adverse events', 'International Index of Erectile Function-Erectile Function domain and the Erectile Hardness Scale assessment', 'International Index of Erectile Function-Erectile Function score', 'Patel P, Katz J, Lokeshwar SD, et', 'Erectile Hardness Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",3600.0,0.0722865,"There were statistically significant (P < .05) improvements in International Index of Erectile Function-Erectile Function score (mean increase of 2.7 [95% CI = 1.2, 4.2] and 2.7 points [95% CI = 1.4, 4.1] for Groups A and B, respectively) and in Erectile Hardness Scale (mean increase of 0.6 points (95% CI = 0.3, 0.8) and 0.5 (95% CI = 0.2, 0.8) for Groups A and B, respectively) at 6 months, with no differences between groups.
","[{'ForeName': 'Premal', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Section of Urology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Soum D', 'Initials': 'SD', 'LastName': 'Lokeshwar', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Molina', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Isildinha M', 'Initials': 'IM', 'LastName': 'Reis', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami, Miller School of Medicine Miami, Miami, FL, USA; Biostatistics and Bioinformatics Shared Resource, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Clavijo', 'Affiliation': 'Department of Urology, University of California, Davis, School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Ranjith', 'Initials': 'R', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, FL, USA. Electronic address: ramasamy@miami.edu.'}]",Sexual medicine,['10.1016/j.esxm.2020.01.010']
731,32186237,Double-blind randomized controlled trial on efficacy of cupulolith repositioning maneuver for treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo.,"Backgrounds: Although various therapeutic maneuvers have been proposed, it is still unclear which maneuver is better to treat apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV). Objectives: This study aimed to assess the therapeutic efficacy of the cupulolith repositioning maneuver (CuRM) in apogeotropic HC-BPPV in comparison with the therapeutic head-shaking maneuver and modified Lempert maneuver. Materials and Method: This is double-blind randomized prospective study. Forty-nine consecutive patients diagnosed with apogeotropic HC-BPPV were allocated randomly to CuRM ( n = 18), therapeutic head-shaking ( n = 16), or modified Lempert maneuver ( n = 15). The presence of nystagmus and vertigo on positional testing were evaluated at 30 min, on 1 day, and 1 week after treatment. Results: There were no significant differences in any clinical characteristics between the three groups at randomization. After a single trial of therapeutic maneuvers on the initial visit day, the CuRM (38.9%) and therapeutic head shaking maneuver (12.5%) did not show differences compared to modified Lempert maneuver (33.3%). The therapeutic effects on the 2nd day and at 1 week after treatment also did not differ between the three groups. Conclusions: Although the CuRM is theoretically considered to be a better therapeutic method, the therapeutic efficacy of CuRM was not statistically different compared to the other two maneuvers.",2020,The therapeutic effects on the 2nd day and at 1 week after treatment also did not differ between the three groups.,"['Forty-nine consecutive patients diagnosed with apogeotropic HC-BPPV', 'apogeotropic horizontal canal benign paroxysmal positional vertigo']","['cupulolith repositioning maneuver (CuRM', 'cupulolith repositioning maneuver', 'CuRM']",['therapeutic efficacy of CuRM'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}]","[{'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]",49.0,0.0402292,The therapeutic effects on the 2nd day and at 1 week after treatment also did not differ between the three groups.,"[{'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kong', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Mee Hyun', 'Initials': 'MH', 'LastName': 'Song', 'Affiliation': 'Department of Otorhinolaryngology, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Jin Wook', 'Initials': 'JW', 'LastName': 'Kang', 'Affiliation': 'Department of Otorhinolaryngology, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Dae Bo', 'Initials': 'DB', 'LastName': 'Shim', 'Affiliation': 'Department of Otorhinolaryngology, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea.'}]",Acta oto-laryngologica,['10.1080/00016489.2020.1736339']
732,32492087,Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial.,"Importance
Abrocitinib, an oral, once-daily Janus kinase 1 selective inhibitor, was effective and well tolerated in a phase 3 monotherapy trial of patients with moderate-to-severe atopic dermatitis (AD).
Objective
To investigate the efficacy and safety of abrocitinib in adolescents and adults with moderate-to-severe AD in an identically designed trial.
Design, Setting, and Participants
This phase 3, double-blinded, placebo-controlled, parallel-group randomized clinical trial included patients 12 years or older with a clinical diagnosis of moderate-to-severe AD for at least 1 year and inadequate response to topical medications given for at least 4 weeks within 6 months. Patients were enrolled from 115 centers in Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, South Korea, Latvia, Poland, United Kingdom, and the United States from June 29, 2018, to August 13, 2019. Data were analyzed from September 13 to October 25, 2019.
Interventions
Patients were randomly assigned (2:2:1) to receive once-daily oral abrocitinib in 200- or 100-mg doses or placebo for 12 weeks.
Main Outcomes and Measures
The coprimary end points were the proportion of patients achieving Investigator Global Assessment (IGA) response (ie, clear [0] or almost clear [1], with improvement of ≥2 grades) and the proportion of patients achieving at least 75% improvement in Eczema Area and Severity Index score (EASI-75) at week 12. Key secondary end points included the proportion of patients achieving a Peak Pruritus Numerical Rating Scale (PP-NRS) response (ie, improvement of ≥4 points) at week 12. Other secondary end points included the proportion of patients achieving at least 90% improvement in EASI score (EASI-90). Safety was assessed via adverse events and laboratory monitoring.
Results
A total of 391 patients (229 male [58.6%]; mean [SD] age, 35.1 [15.1] years) were included in the analysis; of these, 155 received abrocitinib, 200 mg/d; 158, abrocitinib, 100 mg/d; and 78, placebo. Among patients with available data at week 12, greater proportions of patients in the 200- and 100-mg abrocitinib groups vs the placebo group achieved IGA (59 of 155 [38.1%] and 44 of 155 [28.4%] vs 7 of 77 [9.1%]; P < .001) and EASI-75 (94 of 154 [61.0%] and 69 of 155 [44.5%] vs 8 of 77 [10.4%]; P < .001), greater estimated proportions achieved PP-NRS (55.3% [95% CI, 47.2%-63.5%] and 45.2% [95% CI, 37.1%-53.3%] vs 11.5% [95% CI, 4.1%-19.0%]; P < .001), and/or greater proportions achieved EASI-90 (58 of 154 [37.7%] and 37 of 155 [23.9%] vs 3 of 77 [3.9%]) responses. Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group. Decreases in platelet count (2 [1.3%]) and laboratory values indicating thrombocytopenia (5 [3.2%]) were reported in the 200-mg group.
Conclusions and Relevance
Monotherapy with once-daily oral abrocitinib was effective and well tolerated in adolescents and adults with moderate-to-severe AD.
Trial Registration
ClinicalTrials.gov Identifier: NCT03575871.",2020,"Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group.","['patients with moderate-to-severe atopic dermatitis (AD', 'adolescents and adults with moderate-to-severe AD', 'Patients were enrolled from 115 centers in Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, South Korea, Latvia, Poland, United Kingdom, and the United States from June 29, 2018, to August 13, 2019', 'Patients With Moderate-to-Severe Atopic Dermatitis', 'A total of 391 patients (229 male [58.6%]; mean [SD] age, 35.1 [15.1] years) were included in the analysis; of these, 155 received abrocitinib, 200 mg/d; 158, abrocitinib, 100 mg/d; and 78', 'adolescents and adults with moderate-to-severe AD in an identically designed trial', 'patients 12 years or older with a clinical diagnosis of moderate-to-severe AD for at least 1 year and inadequate response to topical medications given for at least 4 weeks within 6 months']","['Abrocitinib', 'abrocitinib', 'receive once-daily oral abrocitinib in 200- or 100-mg doses or placebo', 'placebo']","['Efficacy and Safety', 'platelet count', 'Adverse events', 'proportion of patients achieving a Peak Pruritus Numerical Rating Scale (PP-NRS) response (ie, improvement of ≥4 points', 'EASI-90', 'PP-NRS', 'thrombocytopenia', 'efficacy and safety', 'serious adverse events', 'EASI-75', 'proportion of patients achieving Investigator Global Assessment (IGA) response (ie, clear [0] or almost clear [1], with improvement of ≥2 grades) and the proportion of patients achieving at least 75% improvement in Eczema Area and Severity Index score (EASI-75', 'proportion of patients achieving at least 90% improvement in EASI score (EASI-90', 'IGA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0420210', 'cui_str': 'Medication given'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",391.0,0.644566,"Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group.","[{'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev-Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""SKiN Centre for Dermatology, Queen's University and Probity Medical Research, Peterborough, Ontario, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Feeney', 'Affiliation': 'Pfizer Ltd, Surrey, United Kingdom.'}, {'ForeName': 'Pinaki', 'Initials': 'P', 'LastName': 'Biswas', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Valdez', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'DiBonaventura', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Chudy', 'Initials': 'C', 'LastName': 'Nduaka', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rojo', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.1406']
733,31779928,Impact of Age on Comorbidities and Outcomes in Heart Failure With Reduced Ejection Fraction.,"OBJECTIVES
This study sought to determine whether age modifies the impact of key comorbidities on clinical outcomes for patients with heart failure with reduced ejection fraction (HFrEF).
BACKGROUND
Comorbidities impact outcomes in HFrEF. However, the effect of age on the impact of comorbidities on prognosis is not clearly understood.
METHODS
Cox proportional hazards models were used assessed interactions between age and comorbidities on the primary composite endpoint (all-cause mortality or hospitalization) and secondary endpoints in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) multicenter trial of 2,331 patients with HFrEF.
RESULTS
Age did not significantly modify the effect of any comorbidity on the primary endpoint. However, age significantly modified the effect of body mass index (BMI) on all-cause mortality (interaction p = 0.02). Among patients ≥70 years of age, there was a U-shaped relationship between BMI and 1-year mortality, where BMI of 20 kg/m 2 corresponded to 17.6%; a BMI of 30 kg/m 2 corresponded to 7.0%; and a BMI of 40 kg/m 2 corresponded to 11%. For patients <60 years of age, mortality increased nonsignificantly from 3.2% to 3.7% with increasing BMI. Age also modified the effect of depressive symptoms on all-cause mortality (interaction p = 0.03). Among patients ≥70 years of age, a 1-year mortality rate significantly increased from 7.8% for a Beck Depression Inventory (BDI) score of 5% to 15.6% for BDI of 20. For patients <60 years of age, mortality was nonsignificantly related to BDI. Cumulative comorbidity scores were stronger predictors than age for mortality/hospitalization.
CONCLUSIONS
In chronic HFrEF, age markedly altered the impact of BMI and depressive symptoms on all-cause mortality, with much higher risk in older patients, but was not as strong a predictor of mortality/hospitalizations as cumulative comorbidity score. (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training [HF-ACTION]; NCT00047437).",2019,"Among patients ≥70 years of age, a 1-year mortality rate significantly increased from 7.8% for a Beck Depression Inventory (BDI) score of 5% to 15.6% for BDI of 20.","['patients with heart failure with reduced ejection fraction (HFrEF', 'Heart\xa0Failure', 'Heart Failure', '2,331 patients with HFrEF']",['Exercise Training'],"['mortality', 'Beck Depression Inventory (BDI) score', 'Cumulative comorbidity scores', 'BMI and 1-year mortality', 'body mass index (BMI', '1-year mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score (observable entity)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",2331.0,0.137696,"Among patients ≥70 years of age, a 1-year mortality rate significantly increased from 7.8% for a Beck Depression Inventory (BDI) score of 5% to 15.6% for BDI of 20.","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Regan', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina. Electronic address: jessica.a.regan@duke.edu.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Department of Internal Medicine, Section on Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Forman', 'Affiliation': 'Department of Medicine, University of Pittsburgh and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kishan', 'Initials': 'K', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.09.004']
734,29550314,High-Sensitivity Troponin I and Coronary Computed Tomography in Symptomatic Outpatients With Suspected CAD: Insights From the PROMISE Trial.,"OBJECTIVES
The goal of this study was to examine associations between concentrations of high-sensitivity troponin I (hsTnI) (measured by using a single-molecule counting method) and obstructive coronary artery disease (CAD) in 1,844 stable, symptomatic outpatients with suspected CAD randomized to undergo coronary computed tomography angiography (CTA) in the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) trial.
BACKGROUND
Elevated concentrations of hsTnI are associated with CAD in patients with myocardial infarction. The meaning of hsTnI concentrations in stable symptomatic outpatients is not well understood.
METHODS
Clinical characteristics and CTA results (including coronary artery calcium [CAC] scores) were expressed across hsTnI quartiles. Determinants of hsTnI concentration were identified. Multivariable logistic regression identified independent predictors of obstructive CAD 50 (≥50% stenosis in any vessel) and CAD 70 (≥70% stenosis or ≥50% left main).
RESULTS
The median hsTnI concentration was 1.5 ng/l; nearly all (98.5%) subjects had measurable hsTnI, and 6.1% had concentrations ≥99th percentile concentration for this assay (6 ng/l). Higher CAC scores, as well as more prevalent and diffuse CAD, was seen in upper hsTnI quartiles (all p < 0.001). Independent predictors of hsTnI concentrations included age, sex, and CAC score (all p < 0.05). After adjusting for demographic and clinical characteristics, log-transformed hsTnI concentrations were associated with obstructive CAD 50 (odds ratio: 1.15 per interquartile range; p = 0.02) and CAD 70 (odds ratio: 1.25 per interquartile range; p = 0.001).
CONCLUSIONS
In stable symptomatic outpatients undergoing nonemergent coronary CTA for the diagnosis of suspected CAD, higher concentrations of hsTnI were associated with increasing presence and severity of coronary atherosclerosis. (Prospective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]; NCT01174550).",2019,"Independent predictors of hsTnI concentrations included age, sex, and CAC score (all p < 0.05).","['1,844 stable, symptomatic outpatients with suspected CAD randomized to undergo', 'Symptomatic Outpatients', 'stable symptomatic outpatients undergoing', 'patients with myocardial infarction']","['High-Sensitivity Troponin I and Coronary\xa0Computed Tomography', 'nonemergent coronary CTA', 'coronary computed tomography angiography (CTA']","['Higher CAC scores', 'concentrations of high-sensitivity troponin', 'coronary artery calcium [CAC] scores', 'median hsTnI concentration']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",1844.0,0.129399,"Independent predictors of hsTnI concentrations included age, sex, and CAC score (all p < 0.05).","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: jjanuzzi@partners.org.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Suchindran', 'Affiliation': 'Duke Center for Applied Genomics and Precision Medicine, Durham, North Carolina.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Maros', 'Initials': 'M', 'LastName': 'Ferencik', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Geoffrey S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'Duke Center for Applied Genomics and Precision Medicine, Durham, North Carolina; Department of Medicine, Duke University Medical School, Durham, North Carolina.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Duke University Medical School, Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2018.01.021']
735,31350540,Acute Blood Pressure and Cardiovascular Effects of Near-Roadway Exposures With and Without N95 Respirators.,"BACKGROUND
The risk for cardiovascular events increases within hours of near-roadway exposures. We aimed to determine the traffic-related air pollution (TRAP) and biological mechanisms involved and if reducing particulate matter <2.5 µm (PM2.5) inhalation is protective.
METHODS
Fifty healthy-adults underwent multiple 2-hour near-roadway exposures (Tuesdays to Fridays) in Ann Arbor during 2 separate weeks (randomized to wear an N95 respirator during 1 week). Monday both weeks, participants rested 2 hours in an exam room (once wearing an N95 respirator). Brachial blood pressure, aortic hemodynamics, and heart rate variability were repeatedly measured during exposures. Endothelial function (reactive hyperemia index [RHI]) was measured post-exposures (Thursdays). Black carbon (BC), total particle count (PC), PM2.5, noise and temperature were measured throughout exposures.
RESULTS
PM2.5 (9.3 ± 7.7 µg/m3), BC (1.3 ± 0.6 µg/m3), PC (8,375 ± 4,930 particles/cm3) and noise (69.2 ± 4.2 dB) were higher (P values <0.01) and aortic hemodynamic parameters trended worse while near-roadway (P values<0.15 vs. exam room). Other outcomes were unchanged. Aortic hemodynamics trended towards improvements with N95 respirator usage while near-roadway (P values<0.15 vs. no-use), whereas other outcomes remained unaffected. Higher near-roadway PC and BC exposures were associated with increases in aortic augmentation pressures (P values<0.05) and trends toward lower RHI (P values <0.2). N95 respirator usage did not mitigate these adverse responses (nonsignificant pollutant-respirator interactions). Near-roadway outdoor-temperature and noise were also associated with cardiovascular changes.
CONCLUSIONS
Exposure to real-world combustion-derived particulates in TRAP, even at relatively low concentrations, acutely worsened aortic hemodynamics. Our mixed findings regarding the health benefits of wearing N95 respirators support that further studies are needed to validate if they adequately protect against TRAP given their growing worldwide usage.",2019,"Aortic hemodynamics trended towards improvements with N95-respirator usage while near-roadway (p-values<0.15 versus no-use), whereas other outcomes remained unaffected.",['Fifty healthy-adults underwent multiple 2-hour near-roadway exposures (Tuesdays-Fridays) in Ann Arbor during 2 separate weeks (randomized to wear an N95-respirator during one week'],['particulate matter<2.5 µm (PM2.5) inhalation'],"['Endothelial function (reactive hyperemia index [RHI', 'adverse responses', 'Brachial blood pressure, aortic hemodynamics and heart rate variability', 'Aortic hemodynamics', 'aortic hemodynamic parameters', 'Acute Blood Pressure and Cardiovascular Effects', 'Black carbon (BC), total particle count (PC), PM2.5, noise and temperature', 'aortic augmentation pressures']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0042497', 'cui_str': 'Respirators'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0457784', 'cui_str': 'Particulate (finding)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",50.0,0.0598782,"Aortic hemodynamics trended towards improvements with N95-respirator usage while near-roadway (p-values<0.15 versus no-use), whereas other outcomes remained unaffected.","[{'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Morishita', 'Affiliation': 'Department of Family Medicine, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Speth', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Bard', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Fengyao', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Family Medicine, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Brook', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Rajagopalan', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve Medical School, Cleveland, Ohio, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",American journal of hypertension,['10.1093/ajh/hpz113']
736,31356262,Effect of Remote Ischemic Preconditioning Conducted in Living Liver Donors on Postoperative Liver Function in Donors and Recipients Following Liver Transplantation: A Randomized Clinical Trial.,"OBJECTIVE
This study aimed to assess the effects of remote ischemic preconditioning (RIPC) on liver function in donors and recipients after living donor liver transplantation (LDLT).
BACKGROUND
Ischemia reperfusion injury (IRI) is known to be associated with graft dysfunction after liver transplantation. RIPC is used to lessen the harmful effects of IRI.
METHODS
A total of 148 donors were randomly assigned to RIPC (n = 75) and control (n = 73) groups. RIPC involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to the upper arm, followed by 5-minute reperfusion with cuff deflation. The primary aim was to assess postoperative liver function in donors and recipients and the incidence of early allograft dysfunction and graft failure in recipients.
RESULTS
RIPC was not associated with any differences in postoperative aspartate aminotransferase (AST) and alanine aminotransferase levels after living donor hepatectomy, and it did not decrease the incidence of delayed graft hepatic function (6.7% vs 0.0%, P = 0.074) in donors. AST level on postoperative day 1 [217.0 (158.0, 288.0) vs 259.5 (182.0, 340.0), P = 0.033] and maximal AST level within 7 postoperative days [244.0 (167.0, 334.0) vs 296.0 (206.0, 395.5), P = 0.029) were significantly lower in recipients who received a preconditioned graft. No differences were found in the incidence of early allograft dysfunction (4.1% vs 5.6%, P = 0.955) or graft failure (1.4% vs 5.6%, P = 0.346) among recipients.
CONCLUSIONS
RIPC did not improve liver function in living donor hepatectomy. However, RIPC performed in liver donors may be beneficial for postoperative liver function in recipients after living donor liver transplantation.",2020,"RESULTS
RIPC was not associated with any differences in postoperative aspartate aminotransferase (AST) and alanine aminotransferase levels after living donor hepatectomy, and it did not decrease the incidence of delayed graft hepatic function (6.7% vs 0.0%, P = 0.074) in donors.","['recipients after living donor liver transplantation', 'donors and recipients and the incidence of early allograft dysfunction and graft failure in recipients', 'Donors and Recipients Following Liver Transplantation', 'donors and recipients after living donor liver transplantation (LDLT', 'A total of 148 donors']","['remote ischemic preconditioning (RIPC', 'Remote Ischemic Preconditioning', 'RIPC']","['postoperative aspartate aminotransferase (AST) and alanine aminotransferase levels', 'graft failure', 'liver function', 'maximal AST level', 'Postoperative Liver Function', 'incidence of early allograft dysfunction', 'AST level', 'incidence of delayed graft hepatic function', 'postoperative liver function']","[{'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]",,0.10942,"RESULTS
RIPC was not associated with any differences in postoperative aspartate aminotransferase (AST) and alanine aminotransferase levels after living donor hepatectomy, and it did not decrease the incidence of delayed graft hepatic function (6.7% vs 0.0%, P = 0.074) in donors.","[{'ForeName': 'Kyeo-Woon', 'Initials': 'KW', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Laboratory for Cardiovascular Dynamics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Hye-Mee', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': ''}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'In-Gu', 'Initials': 'IG', 'LastName': 'Jun', 'Affiliation': ''}, {'ForeName': 'Jun-Gol', 'Initials': 'JG', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Gyu-Sam', 'Initials': 'GS', 'LastName': 'Hwang', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003498']
737,31146872,Sex-Based Differences in Outcomes After Mitral Valve Surgery for Severe Ischemic Mitral Regurgitation: From the Cardiothoracic Surgical Trials Network.,"OBJECTIVES
This study investigated sex-based differences in outcomes after mitral valve (MV) surgery for severe ischemic mitral regurgitation (SIMR).
BACKGROUND
Whether differences in outcomes exist between men and women after surgery for SIMR remains unknown.
METHODS
Patients enrolled in a randomized trial comparing MV replacement versus MV repair for SIMR were included and followed for 2 years. Endpoints for this analysis included all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE) (defined as the composite of death, stroke, hospitalization for heart failure, worsening New York Heart Association functional class or MV re-operation), quality of life (QOL), functional status, and percentage of change in left ventricular end-systolic volume index (LVESVI) from baseline through 2 years.
RESULTS
Of 251 patients enrolled in the trial, 96 (38.2%) were women. Compared with men, women had smaller LV volumes and effective regurgitant orifice areas (EROA) but greater EROA/left ventricular (LV) end-diastolic volume ratios. At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02). Women also reported worse QOL and functional status at 2 years. There were no significant differences in the percentage of change over 2 years in LVESVI between women and men (adjβ: -10.4; 95% CI: -23.4 to 2.6; p = 0.12).
CONCLUSIONS
Women with SIMR displayed different echocardiographic features and experienced higher mortality and worse QOL after MV surgery than men. There were no significant differences in the degree of reverse LV remodeling between sexes. (Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation [Severe Ischemic Mitral Regurgitation]; NCT00807040).",2019,"At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02).","['People With Severe Chronic Ischemic Mitral Regurgitation [Severe Ischemic Mitral Regurgitation', 'Severe\xa0Ischemic Mitral Regurgitation', 'severe ischemic mitral regurgitation (SIMR', '251 patients enrolled in the trial, 96 (38.2%) were women', 'men and women after surgery for SIMR remains unknown', 'Patients enrolled']","[""Repairing Versus Replacing the Heart's Mitral Valve"", 'MV replacement versus MV repair for SIMR', 'mitral valve (MV) surgery']","['rates of all-cause mortality', 'smaller LV volumes and effective regurgitant orifice areas (EROA) but greater EROA/left ventricular (LV) end-diastolic volume ratios', 'cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE) (defined as the composite of death, stroke, hospitalization for heart failure, worsening New York Heart Association functional class or MV re-operation), quality of life (QOL), functional status, and percentage of change in left ventricular end-systolic volume index (LVESVI', 'degree of reverse LV remodeling', 'percentage of change over 2 years in LVESVI', 'QOL and functional status', 'mortality and worse QOL']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4087284', 'cui_str': 'Ischaemic mitral regurgitation'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0026264', 'cui_str': 'Bicuspid Valve'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0455833', 'cui_str': 'Left ventricular end diastolic volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0034380'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",251.0,0.277475,"At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02).","[{'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Giustino', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Overbey', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Department of Regenerative Medicine Research, Texas Heart Institute, Houston, Texas.'}, {'ForeName': 'Gorav', 'Initials': 'G', 'LastName': 'Ailawadi', 'Affiliation': 'Division of Thoracic and Cardiovascular Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kirkwood', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'DeRose', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Gillinov', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dagenais', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Mary-Lou', 'Initials': 'ML', 'LastName': 'Mayer', 'Affiliation': 'Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Bagiella', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Grayburn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Smith', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Annetine', 'Initials': 'A', 'LastName': 'Gelijns', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: Annetine.gelijns@mssm.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': ""O'Gara"", 'Affiliation': ""Division of Cardiology, Brigham and Women's' Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Acker', 'Affiliation': 'Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hung', 'Affiliation': 'Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.03.001']
738,31157708,Delayed-Onset Muscle Soreness and Topical Analgesic Alter Corticospinal Excitability of the Biceps Brachii.,"INTRODUCTION
The interactive effect of delayed-onset muscle soreness (DOMS) and a topical analgesic on corticospinal excitability was investigated.
METHODS
Thirty-two participants completed Experiments A (no DOMS) and B (DOMS). For each experiment, participants were randomly assigned to two groups: 1) topical analgesic gel (topical analgesic, n = 8), or 2) placebo gel (placebo, n = 8) group. Before the application of gel (pregel), as well as 5, 15, 30, and 45 min postgel, motor-evoked potential (MEP) area, latency, and silent period, as well as cervicomedullary MEP and maximal compound motor unit action potential areas and latencies were measured. In addition, pressure-pain threshold (PPT) was measured pre-DOMS and at the same timepoints in experiment B.
RESULTS
In experiment A, neither group showed a significant change for any outcome measure. In experiment B, both groups exhibited a significant decrease in PPT from pre-DOMS to pregel. After the application of topical analgesic, but not placebo, there was a significant increase in PPT at 45 min postgel, respectively, compared with pregel and a main effect of time for the silent period to increase compared with pregel. Participants with DOMS had reduced MEP and cervicomedullary MEP areas and increased corticospinal silent periods compared with those who did not have DOMS.
CONCLUSIONS
These findings suggest that DOMS reduced corticospinal excitability and after the administration of menthol-based topical analgesic, there was a reduction in pain, which was accompanied by increased corticospinal inhibition.",2019,"Participants with DOMS had reduced MEP and CMEP areas, and increased corticospinal silent periods compared to those who did not have DOMS.
",['Thirty-two participants completed Experiments A (No DOMS) and B (DOMS'],"['topical analgesic gel (Topical Analgesic, n=8), or 2) placebo gel (Placebo', 'delayed onset muscle soreness (DOMS', 'placebo']","['PPT', 'corticospinal excitability', 'corticospinal silent periods', 'pain', 'corticospinal inhibition', 'pressure-pain threshold (PPT', 'reduced MEP and CMEP areas', 'motor evoked potential (MEP) area, latency, and silent period, as well as cervicomedullary MEP (CMEP) and maximal compound motor unit action potential (Mmax) areas and latencies']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0231503', 'cui_str': 'Muscle motor unit potential, function (observable entity)'}]",32.0,0.202906,"Participants with DOMS had reduced MEP and CMEP areas, and increased corticospinal silent periods compared to those who did not have DOMS.
","[{'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Stefanelli', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL, CANADA.""}, {'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Lockyer', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL, CANADA.""}, {'ForeName': 'Brandon W', 'Initials': 'BW', 'LastName': 'Collins', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL, CANADA.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Snow', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, CANADA.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Crocker', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL, CANADA.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kent', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL, CANADA.""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Power', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL, CANADA.""}, {'ForeName': 'Duane C', 'Initials': 'DC', 'LastName': 'Button', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL, CANADA.""}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002055']
739,31169793,Ultrasound Does Not Detect Acute Changes in Glycogen in Vastus Lateralis of Man.,"PURPOSE
To examine the validity of ultrasound (via cloud-based software that measures pixilation intensity according to a scale of 0-100) to noninvasively assess muscle glycogen in human skeletal muscle.
METHODS
In study 1, 14 professional male rugby league players competed in an 80-min competitive rugby league game. In study 2 (in a randomized repeated measures design), 16 recreationally active males completed an exhaustive cycling protocol to deplete muscle glycogen followed by 36 h of HIGH or LOW carbohydrate intake (8 g·kg vs 3 g·kg body mass). In both studies, muscle biopsies and ultrasound scans were obtained from the vastus lateralis (at 50% of the muscle length) before and after match play in study 1 and at 36 h after glycogen depletion in study 2.
RESULTS
Despite match play reducing (P < 0.01) muscle glycogen concentration (pregame: 443 ± 65; postgame: 271 ± 94 mmol·kg dw, respectively) in study 1, there were no significant changes (P = 0.4) in ultrasound scores (pregame: 47 ± 6, postgame: 49 ± 7). In study 2, muscle glycogen concentration was significantly different (P < 0.01) between HIGH (531 ±129 mmol·kg dw) and LOW (252 ± 64 mmol·kg dw) yet there was no difference (P = 0.9) in corresponding ultrasound scores (HIGH: 56 ± 7, LOW: 54 ± 6). In both studies, no significant correlations (P > 0.05) were present between changes in muscle glycogen concentration and changes in ultrasound scores.
CONCLUSIONS
Data demonstrate that ultrasound (as based on measures of pixilation intensity) is not valid to measure muscle glycogen status within the physiological range (i.e., 200-500 mmol·kg dw) that is applicable to exercise-induced muscle glycogen utilization and postexercise muscle glycogen resynthesis.",2019,"Despite match play reducing (P< 0.01) muscle glycogen concentration (Pre-game: 443 ± 65; Post-game: 271 ± 94 mmol.kg dw, respectively) in Study 1, there were no significant changes (P=0.4) in ultrasound scores","['Vastus Lateralis of Man', '14 professional male rugby league players competed in an 80-minute competitive rugby league game', '16 recreationally active males completed an', 'human skeletal muscle']",['exhaustive cycling protocol to deplete muscle glycogen followed by 36 hours of HIGH or LOW carbohydrate intake'],"['ultrasound scores', 'muscle glycogen concentration', 'muscle glycogen concentration and changes in ultrasound scores']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",14.0,0.038342,"Despite match play reducing (P< 0.01) muscle glycogen concentration (Pre-game: 443 ± 65; Post-game: 271 ± 94 mmol.kg dw, respectively) in Study 1, there were no significant changes (P=0.4) in ultrasound scores","[{'ForeName': 'Harry E', 'Initials': 'HE', 'LastName': 'Routledge', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UNITED KINGDOM.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Bradley', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UNITED KINGDOM.'}, {'ForeName': 'Sam O', 'Initials': 'SO', 'LastName': 'Shepherd', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UNITED KINGDOM.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cocks', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UNITED KINGDOM.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Erskine', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UNITED KINGDOM.'}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Close', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UNITED KINGDOM.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Morton', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002052']
740,32170551,SERPINE-1 Gene Methylation and Protein as Molecular Predictors of Laparoscopic Sleeve Gastrectomy Outcome.,"BACKGROUND
Body weight is subjected to genetic and epigenetic modifiers that might affect the success of weight loss interventions. Because of its possible complications and disparity in patients' response, identification of predictors to the outcome of bariatric surgery is indispensable.
OBJECTIVES
This prospective study aims to investigate serpin peptidase inhibitor type 1 (SERPINE-1) protein and gene methylation as molecular predictors to the outcome of bariatric surgery.
PATIENTS AND METHODS
One hundred participants were enrolled and divided to control group (n = 50) and obese patients who underwent laparoscopic sleeve gastrectomy (LSG) (n = 50). Anthropometric measurements were assessed and blood samples were collected preoperatively and 6 months postoperatively for assessment of SERPINE-1 protein and gene methylation, C-reactive protein (CRP), and homeostatic model assessment of insulin resistance (HOMA-IR). Moreover, subjects were followed for 2 years for weight loss parameters.
RESULTS
Patients with obesity showed high baseline SERPINE-1 protein and gene hypermethylation where LSG was followed by a drop in SERPINE-1 protein level but not gene hypermethylation. Baseline SERPINE-1 gene methylation was negatively related to postoperative weight loss and was the independent predictor to weight loss after LSG. Likewise, postoperative SERPINE-1 protein was negatively related to weight loss with independent expression from its gene methylation state. Furthermore, postoperative SERPINE-1 gene methylation correlated to CRP and HOMA-IR.
CONCLUSION
Baseline SERPINE-1 gene methylation might be a predictor of weight loss after LSG. Meanwhile, postoperative SERPINE-1 protein could be a predictor to weight loss maintenance after LSG. Lastly, postoperative SERPINE-1 gene methylation might serve as an index to postoperative changes in obesity-related comorbidities.",2020,Baseline SERPINE-1 gene methylation was negatively related to postoperative weight loss and was the independent predictor to weight loss after LSG.,['One hundred participants were enrolled and divided to control group (n\u2009=\u200950) and obese patients who underwent'],['laparoscopic sleeve gastrectomy (LSG'],"['weight loss', 'protein and gene methylation, C-reactive protein (CRP), and homeostatic model assessment of insulin resistance (HOMA-IR', 'postoperative weight loss']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",100.0,0.0189398,Baseline SERPINE-1 gene methylation was negatively related to postoperative weight loss and was the independent predictor to weight loss after LSG.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Assem', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Tamer N', 'Initials': 'TN', 'LastName': 'Abdelbaki', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Safaa H', 'Initials': 'SH', 'LastName': 'Mohy-El Dine', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Amel F', 'Initials': 'AF', 'LastName': 'Ketat', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Doaa A', 'Initials': 'DA', 'LastName': 'Abdelmonsif', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Medicine, University of Alexandria, Alexandria, Egypt. doaa.elmonsif@alexmed.edu.eg.'}]",Obesity surgery,['10.1007/s11695-020-04533-0']
741,32170552,The Prognostic Value of the Dutch Sweet Eating Questionnaire on Weight Loss After Metabolic Surgery: a Randomized Controlled Trial.,"BACKGROUND
Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) have shown different weight loss results. These differences might be partly due to dumping after LRYGB, forcing sweet eaters to switch to a healthy diet. The Dutch Sweet Eating Questionnaire (DSEQ) is validated to measure sweet eating. This study aims to investigate if sweet eating measured with the DSEQ influences weight loss.
METHODS
In this multicenter randomized controlled trial, patients were included between 2013 and 2017 in two Dutch high-volume hospitals, and randomized with a 1:1 ratio between LRYGB and LSG. Primary outcome measure was weight loss. Secondary outcome measure was sweet eating behavior, measured with the DSEQ. Data was collected at baseline, 1 year and 2 years postoperatively.
RESULTS
Data was analyzed of 623 patients who underwent LRYGB (n = 308; 49.4%) or LSG (n = 315; 50.6%). Follow-up rates at 2 years postoperative were 67.1% for weight and 35.3% for DSEQ. At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m 2 , p < 0.001), and the percentage of sweet eaters was significantly higher after LSG than LRYGB (respectively 8.6% versus 2.6%, p = 0.049). None of the preoperative sweet eaters were sweet eaters 2 years after LRYGB (0.0%), versus 11.8% 2 years after LSG. No correlation was found between postoperative sweet eating behavior and %EBMIL.
CONCLUSION
No significant correlation was found between preoperative or postoperative sweet eating measured with the DSEQ and weight loss. The decision-making for the procedure type is more complex than weight loss and dietary habits, and should also involve quality of life and presence of comorbidities. These factors should be addressed in future research along with longer term results.
TRIAL REGISTRATION
Dutch Trial Register NTR-4741.",2020,"At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m 2 , p < 0.001), and the percentage of sweet eaters was significantly higher after LSG than LRYGB (respectively 8.6% versus 2.6%, p = 0.049).","['patients were included between 2013 and 2017 in two Dutch high-volume hospitals, and randomized with a 1:1 ratio between LRYGB and LSG', '623 patients who underwent LRYGB (n\u2009=\u2009308; 49.4%) or']","['LSG', 'Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG']","['preoperative or postoperative sweet eating', 'weight loss', 'sweet eating behavior, measured with the DSEQ', 'DSEQ and weight loss', 'Weight Loss', 'postoperative sweet eating behavior and %EBMIL', 'mean BMI', 'percentage of sweet eaters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C3494218', 'cui_str': 'Hospitals, High-Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.124103,"At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m 2 , p < 0.001), and the percentage of sweet eaters was significantly higher after LSG than LRYGB (respectively 8.6% versus 2.6%, p = 0.049).","[{'ForeName': 'L U', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leeman', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands. M.Leeman@Franciscus.nl.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Friskes', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'der Kinderen', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Apers', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dunkelgrun', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Zengerink', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Smulders', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}]",Obesity surgery,['10.1007/s11695-020-04527-y']
742,31256018,"Development of a peer-led, network mapping intervention to improve the health of individuals with severe mental illnesses: protocol for a pilot study.","INTRODUCTION
Adults with severe mental illness (SMI) have reduced life expectancy and many have comorbid physical health conditions. Primary care providers are experiencing increased demands for care for people with SMI. Barriers to accessing physical healthcare have been identified which negatively affect quality of care. We propose that peer support workers (PSWs) could deliver an intervention to service users to promote their physical health by drawing on existing social support. The aim of this research was to pilot a novel PSW-led intervention, including personal well-being network mapping, to improve access to primary care for physical health needs.
METHODS AND ANALYSIS
Twenty-four participants will be recruited from community-based mental health teams in two boroughs of London. Each participant will be offered a six-session intervention. Quantitative data will be collected before and after intervention (at 4-month follow-up). Qualitative interviews will be conducted with PSWs after completion of the intervention and with participants at a 4-month follow-up. Some intervention sessions will be observed by a member of the research team. This is a pilot study with a small sample aiming to assess acceptability and feasibility of an intervention. We aim to use the results to refine the existing theory of change and to optimise the intervention and its evaluation in a future randomised controlled trial. This study is strengthened by its potential clinical importance and origin in previous research where service users engaged with well-being network mapping.
ETHICS AND DISSEMINATION
This study has been approved by the London-Chelsea Regional Ethics Committee (ref: 17/LO/0585). The findings will be disseminated to participants, the National Health Service trusts that we recruited from, primary care mental health leads, commissioners and in peer-reviewed journals and academic conferences.",2019,"The findings will be disseminated to participants, the National Health Service trusts that we recruited from, primary care mental health leads, commissioners and in peer-reviewed journals and academic conferences.","['individuals with severe mental illnesses', 'Adults with severe mental illness (SMI', 'Twenty-four participants will be recruited from community-based mental health teams in two boroughs of London']","['network mapping intervention', 'peer support workers (PSWs']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],24.0,0.108888,"The findings will be disseminated to participants, the National Health Service trusts that we recruited from, primary care mental health leads, commissioners and in peer-reviewed journals and academic conferences.","[{'ForeName': 'Jennifer Rose Deborah', 'Initials': 'JRD', 'LastName': 'Collom', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Davidson', 'Affiliation': 'Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Sweet', 'Affiliation': 'McPin Foundation, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gillard', 'Affiliation': ""Division of Population Health Sciences and Education, St George's University of London, London, UK.""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Pinfold', 'Affiliation': 'McPin Foundation, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': ""King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2018-023768']
743,32182123,The effect of acute dual SGLT1/SGLT2 inhibition on incretin release and glucose metabolism after gastric bypass surgery.,"Enhanced meal-related enteroendocrine secretion, particularly of glucagon-like peptide-1 (GLP-1), contributes to weight-loss and improved glycemia after Roux-en-Y gastric bypass (RYGB). Dietary glucose drives GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) secretion postoperatively. Understanding how glucose triggers incretin secretion following RYGB could lead to new treatments of diabetes and obesity. In vitro, incretin release depends on glucose absorption via sodium-glucose cotransporter 1 (SGLT1). We investigated the importance of SGLT1/SGLT2 for enteropancreatic hormone concentrations and glucose metabolism after RYGB in a randomized, controlled, crossover study. Ten RYGB-operated patients ingested 50 g of oral glucose with and without acute pretreatment with 600 mg of the SGLT1/SGLT2-inhibitor canagliflozin. Paracetamol and 3- O -methyl-d-glucopyranose (3-OMG) were added to the glucose drink to evaluate rates of intestinal entry and absorption of glucose, respectively. Blood samples were collected for 4 h. The primary outcome was 4-h plasma GLP-1 (incremental area-under the curve, iAUC). Secondary outcomes included glucose, GIP, insulin, and glucagon. Canagliflozin delayed glucose absorption (time-to-peak 3-OMG: 50 vs. 132 min, P < 0.01) but did not reduce iAUC GLP-1 (6,067 vs. 7,273·min·pmol -1 ·L -1 , P = 0.23), although peak GLP-1 concentrations were lowered (-28%, P = 0.03). Canagliflozin reduced GIP (iAUC -28%, P = 0.01; peak concentrations -57%, P < 0.01), insulin, and glucose excursions, whereas plasma glucagon (AUC 3,216 vs. 4,160 min·pmol·L -1 , P = 0.02) and amino acids were increased. In conclusion, acute SGLT1/SGLT2-inhibition during glucose ingestion did not reduce 4-h plasma GLP-1 responses in RYGB-patients but attenuated the early rise in GLP-1, GIP, and insulin, whereas late glucagon concentrations were increased. The results suggest that SGLT1-mediated glucose absorption contributes to incretin hormone secretion after RYGB.",2020,"Canagliflozin reduced GIP (iAUC -28%, p=0.01; peak concentrations -57%, p<0.01), insulin and glucose excursions, whereas plasma glucagon (AUC 3216 vs. 4160 min∙pmol/l, p=0.02) and amino acids were increased.",['gastric bypass surgery'],"['acute dual SGLT1/SGLT2 inhibition', 'oral glucose ± acute pretreatment with 600 mg of the SGLT1/SGLT2-inhibitor canagliflozin', 'Paracetamol and 3-O-methyl-D-glucopyranose (3-OMG', 'SGLT1/SGLT2']","['4-h plasma GLP-1 (incremental area-under-the-curve, iAUC', '4-h plasma GLP-1 responses', 'peak GLP-1 concentrations', 'Blood samples', 'incretin release and glucose metabolism', 'glucose absorption via sodium-glucose cotransporter-1 (SGLT1', 'Canagliflozin delayed glucose absorption', 'iAUC GLP-1', 'insulin and glucose excursions', 'plasma glucagon', 'late glucagon concentrations', 'Canagliflozin reduced GIP', 'weight-loss and improved glycemia', 'glucose, GIP, insulin and glucagon', 'amino acids']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0248805', 'cui_str': 'Sodium-Glucose Transporter 1'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]",10.0,0.0401356,"Canagliflozin reduced GIP (iAUC -28%, p=0.01; peak concentrations -57%, p<0.01), insulin and glucose excursions, whereas plasma glucagon (AUC 3216 vs. 4160 min∙pmol/l, p=0.02) and amino acids were increased.","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Martinussen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Veedfald', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Dirksen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Kirstine N', 'Initials': 'KN', 'LastName': 'Bojsen-Møller', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Svane', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Viggo B', 'Initials': 'VB', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Fenger', 'Affiliation': 'Department of Clinical Biochemistry, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00023.2020']
744,32175901,Cemented versus uncemented hemiarthroplasty for displaced femoral neck fractures: A randomized controlled trial with two years follow-up.,"OBJECTIVE
The aim of this prospective randomized trial was to compare cemented (CHA) and uncemented bipolar hemiarthroplasty (UCH) in patients with femoral neck fractures (FNF).
METHODS
The study included 158 patients aged ≥76 years who underwent bipolar HA for displaced FNF. Patients were randomized in two groups: the cemented group (CHA, n=79) was treated with cement and the uncemented group (UCH, n=79) without cement. The groups were compared for operating time, blood loss and peroperative morbidity and mortality rates.
RESULTS
Both the CHA and the UCH group did not differ significantly in terms of age (86±5 vs. 84±4 years), sex (58.3% male vs. 60.7% female), and comorbidities (p=0.49). The CHA group had a significantly longer operating time (p=0.038) and a greater intraoperative blood loss (p=0.024). In the CHA group there were 8 (10.1%) events of intraoperative drop in the oxygen saturation (SaO2), whereas no such events were noted in the UCH group (p=0.009). Despite no significant difference between these two groups, we found that the CHA group was associated with a higher early postoperative mortality (8.8% in the CHA group versus 3.8% in the UCH group, p=0.009). Intraoperative fracture occurred in two patients (2.5%) of the UCH group. Over a 2-year follow-up period there were no significant differences between the groups regarding the rate of dislocation (p=0.56) or rate of postoperative periprosthetic fracture (p=0.56). There was a trend towards a better postoperative functional recovery at 6 week for the CHA group (77.1±13.1 versus 71.3±16.3), although the mean Harris Hip Score (HHS) at the end of 2 years was comparable (p=0.55).
CONCLUSION
Both CHA and UCH are acceptable methods for treating displaced femoral neck fractures. However, based on our results perioperative cardiovascular disturbances are less frequent and resulting in a potential lower early mortality with UCH. Therefore, UCH is particularly appropriate for elderly patients with pre-existing cardiovascular comorbidities.
LEVEL OF EVIDENCE
Level II, Randomized Controlled Trial.",2020,The CHA group had a significantly longer operating time (p=0.038) and a greater intraoperative blood loss (p=0.024).,"['elderly patients with pre-existing cardiovascular comorbidities', '158 patients aged ≥76 years who underwent bipolar HA for displaced FNF', 'displaced femoral neck fractures', 'patients with femoral neck fractures (FNF']","['cemented (CHA) and uncemented bipolar hemiarthroplasty (UCH', 'Cemented versus uncemented hemiarthroplasty', 'cemented group (CHA, n=79) was treated with cement and the uncemented group (UCH, n=79) without cement', 'CHA', 'CHA and UCH', 'UCH']","['early postoperative mortality', 'postoperative functional recovery', 'operating time, blood loss and peroperative morbidity and mortality rates', 'oxygen saturation (SaO2', 'mean Harris Hip Score (HHS', 'rate of dislocation (p=0.56) or rate of postoperative periprosthetic fracture', 'longer operating time', 'intraoperative blood loss', 'Intraoperative fracture']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C2609162', 'cui_str': 'Periprosthetic Fractures'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0436007', 'cui_str': 'Intraoperative fracture (disorder)'}]",158.0,0.0601205,The CHA group had a significantly longer operating time (p=0.038) and a greater intraoperative blood loss (p=0.024).,"[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Movrin', 'Affiliation': 'Department of Traumatology, University Medical Centre Maribor, Maribor, Slovenia.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.01.432']
745,31030606,Effects of Blood Pressure Lowering on Clinical Outcomes According to Baseline Blood Pressure and Cardiovascular Risk in Patients With Type 2 Diabetes Mellitus.,"The optimal blood pressure (BP) goal in patients with diabetes mellitus remains controversial. We examined whether benefits and risks of intensified antihypertensive therapy in diabetes mellitus are influenced by either baseline BP or cardiovascular disease (CVD) risk. We studied 10 948 people with diabetes mellitus, at moderate-to-high risk, in the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation). Cox models were used to determine whether baseline BP category or CVD risk modified the outcomes of combination perindopril-indapamide treatment, compared with placebo. During 4.3 years of follow-up, treatment with perindopril-indapamide versus placebo reduced mortality and major vascular (macrovascular or microvascular) events. There was no evidence of differences in these effects, regardless of baseline systolic BP (evaluated down to <120 mm Hg; P for heterogeneity, 0.85), diastolic BP (evaluated down to <70 mm Hg; P=0.49), or whether 10-year CVD risk was ≥20% or <20% ( P=0.08). The effects of randomized treatment on discontinuation of treatment because of cough or hypotension/dizziness were also statistically consistent across subgroups defined by baseline BP and CVD risk (all P ≥0.08). Adults with diabetes mellitus appear to benefit from more intensive BP treatment even at levels of BP and CVD risk that some guidelines do not currently recommend for intervention. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00751972.",2019,"There was no evidence of differences in these effects, regardless of baseline systolic BP (evaluated down to <120 mm Hg; P for heterogeneity, 0.85), diastolic BP (evaluated down to <70 mm Hg; P=0.49), or whether 10-year CVD risk was ≥20% or <20% ( P=0.08).","['Patients With Type 2 Diabetes Mellitus', 'patients with diabetes mellitus', 'Adults with diabetes mellitus', '948 people with diabetes mellitus, at moderate-to-high risk, in the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation']","['placebo', 'Blood Pressure Lowering', 'intensified antihypertensive therapy', 'perindopril-indapamide', 'perindopril-indapamide versus placebo']","['baseline systolic BP', '10-year CVD risk', 'mortality and major vascular (macrovascular or microvascular) events', 'cough or hypotension/dizziness', 'blood pressure (BP) goal', 'diastolic BP', 'baseline BP and CVD risk', 'baseline BP or cardiovascular disease (CVD) risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C1530300', 'cui_str': 'Preterax'}, {'cui': 'C0678204', 'cui_str': 'Diamicron'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy (procedure)'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",10948.0,0.353346,"There was no evidence of differences in these effects, regardless of baseline systolic BP (evaluated down to <120 mm Hg; P for heterogeneity, 0.85), diastolic BP (evaluated down to <70 mm Hg; P=0.49), or whether 10-year CVD risk was ≥20% or <20% ( P=0.08).","[{'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Rahman', 'Affiliation': 'From the Division of Cardiology, Department of Medicine (F.R.), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'McEvoy', 'Affiliation': 'Department of Medicine, Ciccarone Center for the Prevention of Heart Disease (F.R., J.W.M.), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (T.O., A.R., J.C., M.W.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Marre', 'Affiliation': 'Department of Diabetology, Endocrinology, and Nutrition, Assistance Publique-Hôpitaux de Paris, Bichat Hospital, France (M.M.).'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Hamet', 'Affiliation': ""Montreal Diabetes Research Centre, Centre Hospitalier de l'Université de Montréal, Québec, Canada (P.H.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'The University of Melbourne and Royal Melbourne Hospital, Victoria, Australia (S.H.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'University of Milan-Bicocca, Instituto Auxologico Italiano, Italy (G.M.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (T.O., A.R., J.C., M.W.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Selvin', 'Affiliation': 'Department of Epidemiology, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (J.W.M., E.S., M.W.).'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Sciences, University College London and National Institute of Health Research University College London Hospitals Biomedical Research Centre, United Kingdom (B.W.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham (P.M.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (T.O., A.R., J.C., M.W.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'From the Division of Cardiology, Department of Medicine (F.R.), Johns Hopkins University School of Medicine, Baltimore, MD.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.118.12414']
746,32162204,TrimetaziDine as a Performance-enhancING drug in heart failure with preserved ejection fraction (DoPING-HFpEF): rationale and design of a placebo-controlled cross-over intervention study.,"BACKGROUND
Currently, no specific treatment exists for heart failure with preserved ejection fraction (HFpEF). Left ventricular (LV) relaxation during diastole is a highly energy-demanding process, while energy homeostasis is known to be compromised in HFpEF. We hypothesise that trimetazidine - a fatty acid β‑oxidation inhibitor - improves LV diastolic function in HFpEF, by altering myocardial substrate use and improving the myocardial energy status.
OBJECTIVES
To assess whether trimetazidine improves LV diastolic function by improving myocardial energy metabolism in HFpEF.
METHODS
The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF. The main inclusion criteria are: New York Heart Association functional class II to IV, LV ejection fraction ≥50%, and evidence of LV diastolic dysfunction. Patients are treated with one 20-mg trimetazidine tablet or placebo thrice daily (twice daily in the case of moderate renal dysfunction) for two periods of 3 months separated by a 2-week washout period. The primary endpoint is the change in pulmonary capillary wedge pressure during different intensities of exercise measured by right heart catheterisation. Our key secondary endpoint is the myocardial phosphocreatine (PCr)/ATP ratio measured by phosphorus-31 magnetic resonance spectroscopy and its relation to the primary endpoint. Exploratory endpoints are 6‑min walk distance, N-terminal pro-brain natriuretic peptide levels, and quality of life.
CONCLUSION
The DoPING-HFpEF is a phase-II trial that evaluates the effect of trimetazidine, a metabolic modulator, on diastolic function and myocardial energy status in HFpEF. [EU Clinical Trial Register: 2018-002170-52; NTR registration: NL7830].",2020,"The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF.","['heart failure with preserved ejection fraction (DoPING-HFpEF', '25\xa0patients with stable HFpEF']","['trimetazidine -\xa0a\xa0fatty acid β‑oxidation inhibitor ', 'placebo', 'TrimetaziDine', 'trimetazidine and placebo', 'trimetazidine', 'trimetazidine tablet or placebo']","['myocardial phosphocreatine (PCr)/ATP ratio', '6‑min walk distance, N-terminal pro-brain natriuretic peptide levels, and quality of life', 'LV diastolic function', 'change in pulmonary capillary wedge pressure during different intensities of exercise measured by right heart catheterisation']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C1533071', 'cui_str': 'N-terminal pro-brain natriuretic peptide measurement'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086879', 'cui_str': 'Pulmonary Capillary Wedge Pressure'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart (procedure)'}]",,0.228946,"The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF.","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'van de Bovenkamp', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Bakermans', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Allaart', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Nederveen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'W E M', 'Initials': 'WEM', 'LastName': 'Kok', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam, The Netherlands.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Handoko', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands. ml.handoko@amsterdamumc.nl.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01407-z']
747,30552531,Enhancing coping skills for persons with cancer utilizing mastery enhancement: a pilot randomized clinical trial.,"The purpose of this project was to develop a short-term, theory-based intervention for patients with self-reported limited self-efficacy to perform coping behaviors. Cancer patients with low coping self-efficacy were randomly assigned to a treatment (N = 66) or control condition (N = 68). The treatment, Mastery Enhancement Therapy, was based on self-regulation and self-efficacy theories. Measures of coping self-efficacy, functional status, depression, quality of life, and adjustment were administered at baseline, after session two, after the final (fourth) session, and at 3 months post-treatment. Control participants completed the measures at about the same time intervals. Treatment participants reported highly significant immediate post-treatment improvement in self-efficacy for coping compared to controls, although controls improved by 3 months post-treatment. However, treatment participants with lower levels of functional status benefited more than controls on depression and adjustment at follow-up. Mastery Enhancement Therapy is a time-limited treatment that increases coping efficacy and subsequently adjustment during active medical treatment, and appears to warrant a large-scale RCT with patients with below average coping self-efficacy and moderate to high symptoms.",2019,"Treatment participants reported highly significant immediate post-treatment improvement in self-efficacy for coping compared to controls, although controls improved by 3 months post-treatment.","['Cancer patients with low coping self-efficacy', 'patients with self', 'persons with cancer utilizing mastery enhancement']",[],"['coping self-efficacy, functional status, depression, quality of life, and adjustment', 'Enhancing coping skills', 'self-efficacy']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}]",,0.0149667,"Treatment participants reported highly significant immediate post-treatment improvement in self-efficacy for coping compared to controls, although controls improved by 3 months post-treatment.","[{'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Nairn', 'Affiliation': ', Novi, MI, USA.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Merluzzi', 'Affiliation': 'University of Notre Dame, Notre Dame, IN, 46556, USA. tmerluzz@nd.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-018-0004-y']
748,31543954,Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial.,"Background: Randomised controlled trials (RCTs) often fail to recruit to target, resulting in a lack of generalisability of findings. A wide range of strategies for potentially increasing recruitment have been identified; however, their effectiveness has not been established. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of handwritten personalisation of an invitation letter as part of a trial recruitment pack on recruitment to a host RCT. Methods: A pragmatic, two-armed RCT was conducted, embedded within an existing falls prevention trial (OTIS) in men and women aged 65 years and over living in the community. Participants were randomised 1:1 to receive an OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group). The primary outcome was randomisation into the host trial. Secondary outcomes related to trial eligibility and retention. Analyses were via logistic regression and Cox Proportional Hazards regression. Results: Of the 317 SWAT participants, 12 (3.8%) were randomised into the OTIS trial: 3 (handwritten: 3/159 [1.9%]; printed: 9/158 [5.7%]; difference -3.8%, 95% CI -8.0% to 0.4%). There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09). There were no statistically significant differences between the intervention and control groups on any of the secondary outcomes. Conclusions: There was no evidence that personalisation of invitation letters improved recruitment to the OTIS trial. However, due to the small sample size, the results should be interpreted with caution. These findings need to be replicated across larger studies and wider populations. Registration: ISRCTN22202133.",2019,"There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09).","['317 SWAT participants, 12 (3.8', 'men and women aged 65 years and over living in the community']","['OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group']","['personalisation of invitation letters', 'trial eligibility and retention']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.478752,"There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McCaffery', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cockayne', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rodgers', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Relton', 'Affiliation': 'SCHARR, University of Sheffield, Sheffield, South Yorkshire, S1 4DA, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Torgerson', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.18939.1']
749,31092647,Systematic client feedback to brief therapy in basic mental healthcare: study protocol for a four-centre clinical trial.,"INTRODUCTION
The Partners for Change Outcome Management System (PCOMS) is a client feedback-system built on two brief visual analogue self-report scales. Prior studies of PCOMS have found effects varying from significant positive to negative. Aims of present study are; to test the predicted beneficial impact of PCOMS, while accounting for methodological flaws in prior studies and to clarify under which circumstances the addition of PCOMS to therapy has a beneficial effect.
METHODS AND ANALYSIS
This study focuses on patients applying for brief, time-limited treatments. Four centres will be randomised to either treatment as usual (TAU) or TAU with PCOMS. All participating patients will be assessed four times. The full staff in the experimental condition will be trained in PCOMS. In the second part of this study, all therapists in the PCOMS condition will fill in a questionnaire concerning the influence of regulatory focus, self-efficacy, external or internal feedback orientation and perceived feedback validity of PCOMS. Finally, patients in the PCOMS condition will be asked to give feedback through a structured interview.The primary outcome measure is the Outcome Questionnaire over the period from beginning to end of therapy. The Mental Health Continuum-Short Form and Consumer Quality Index are also completed. In the primary analysis, outcomes of the two treatment conditions on treatment outcome, patient satisfaction, costs, drop-out and duration will be examined with a three-level (within patient, between patients and between therapists) multilevel analysis. The DSM-classification, sex, education level, age of each patient and therapist factors will be included as covariates.
ETHICS AND DISSEMINATION
The Medical Ethics Committee of the University of Twente approved this study (K15-11, METC Twente). Data will be included from 1 January 2016 to 1 July 2019. Study results will be disseminated through peer-reviewed journals and conferences.
TRIAL REGISTRATION NUMBER
NTR5466; Pre-results.",2019,"In the primary analysis, outcomes of the two treatment conditions on treatment outcome, patient satisfaction, costs, drop-out and duration will be examined with a three-level (within patient, between patients and between therapists) multilevel analysis.","['included from 1 January 2016 to 1 July 2019', 'basic mental healthcare']",['usual (TAU) or TAU with PCOMS'],"['treatment outcome, patient satisfaction, costs, drop-out and duration will be examined with a three-level', 'Outcome Questionnaire over the period from beginning to end of therapy', 'Mental Health Continuum-Short Form and Consumer Quality Index']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0085415'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.121993,"In the primary analysis, outcomes of the two treatment conditions on treatment outcome, patient satisfaction, costs, drop-out and duration will be examined with a three-level (within patient, between patients and between therapists) multilevel analysis.","[{'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Bovendeerd', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, Faculty of Behavioural and Social Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'de Jong', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Colijn', 'Affiliation': 'GGZ Center for Mental Health Care, GGZ Delfland, Delft, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'de Groot', 'Affiliation': 'GGZ center for mental health care, Dimence, Deventer, The Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Hafkenscheid', 'Affiliation': 'Outpatient Clinic, Arkin/Sinaï Centre Jewish Mental Health Services, Amersfoort/Amstelveen, The Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Moerbeek', 'Affiliation': 'Department of Methodology and Statistics, University of Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'de Keijser', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, Faculty of Behavioural and Social Sciences, University of Groningen, Groningen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2018-025701']
750,30907624,Cooking and Gardening Behaviors and Improvements in Dietary Intake in Hispanic/Latino Youth.,"Background: School gardening interventions typically include cooking and gardening (CG) components; however, few studies have examined associations between CG psychosocial behaviors (attitudes, self-efficacy, and motivation), dietary intake, and obesity parameters. This study assessed the association between changes in CG behaviors with changes in dietary intake and obesity in participants of the LA Sprouts study, an after-school, 12-week, randomized controlled CG intervention conducted in four inner-city elementary schools in Los Angeles. Methods: Process analysis using data from 290 low-income, primarily Hispanic/Latino third through fifth-grade students who were randomized to either the LA Sprouts intervention ( n = 160) or control group ( n = 130). Height, weight, waist circumference, dietary intake via questionnaire, and CG behaviors were collected at baseline and postintervention. Linear regressions determined whether changes in CG behaviors predicted changes in dietary intake and obesity outcomes. Results: There were no differences in changes in CG psychosocial behaviors between intervention and control groups, therefore groups were combined. Participants were 49% male, 87% Hispanic/Latino, and an average age of nine. Increases in cooking behaviors significantly predicted increases in dietary fiber intake ( p = 0.004) and increases in vegetable intake ( p = 0.03). Increases in gardening behaviors significantly predicted increased intake of dietary fiber ( p = 0.02). Changes in CG behaviors were not associated with changes in BMI z-score or waist circumference. Conclusions: Results from this study suggest that school-based interventions should incorporate CG components, despite their potentially costly and time-intensive nature, as these behaviors may be responsible for improvements in dietary intake of high-risk minority youth.",2019,Increases in cooking behaviors significantly predicted increases in dietary fiber intake ( p = 0.004) and increases in vegetable intake ( p = 0.03).,"['participants of the LA Sprouts study, an after-school, 12-week, randomized controlled CG intervention conducted in four inner-city elementary schools in Los Angeles', 'Hispanic/Latino Youth', '290 low-income, primarily Hispanic/Latino third through fifth-grade students', 'Participants were 49% male, 87% Hispanic/Latino, and an average age of nine']","['School gardening interventions typically include cooking and gardening (CG) components', 'LA Sprouts intervention']","['BMI z-score or waist circumference', 'Height, weight, waist circumference, dietary intake via questionnaire, and CG behaviors', 'CG psychosocial behaviors (attitudes, self-efficacy, and motivation), dietary intake, and obesity parameters', 'dietary fiber intake', 'intake of dietary fiber', 'dietary intake and obesity outcomes', 'vegetable intake', 'Dietary Intake', 'CG psychosocial behaviors', 'CG behaviors', 'cooking behaviors']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0647859', 'cui_str': 'AM49'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake (observable entity)'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}]",290.0,0.019553,Increases in cooking behaviors significantly predicted increases in dietary fiber intake ( p = 0.004) and increases in vegetable intake ( p = 0.03).,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': '1 Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Annie K', 'Initials': 'AK', 'LastName': 'Markowitz', 'Affiliation': '1 Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Asigbee', 'Affiliation': '1 Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gatto', 'Affiliation': '2 School of Community and Global Health, Claremont Graduate University, Claremont, CA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spruijt-Metz', 'Affiliation': '3 Center for Economic and Social Research, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': '1 Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX.'}]",Childhood obesity (Print),['10.1089/chi.2018.0110']
751,31229636,Mild acute stress improves response speed without impairing accuracy or interference control in two selective attention tasks: Implications for theories of stress and cognition.,"Acute stress is generally thought to impair performance on tasks thought to rely on selective attention. This effect has been well established for moderate to severe stressors, but no study has examined how a mild stressor-the most common type of stressor-influences selective attention. In addition, no study to date has examined how stress influences the component processes involved in overall selective attention task performance, such as controlled attention, automatic attentional activation, decision-making, and motor abilities. To address these issues, we randomly assigned 107 participants to a mild acute stress or control condition. As expected, the mild acute stress condition showed a small but significant increase in cortisol relative to the control condition. Following the stressor, we assessed attention with two separate flanker tasks. One of these tasks was optimized to investigate component attentional processes using computational cognitive modeling, whereas the other task employed mouse-tracking to illustrate how response conflict unfolded over time. The results for both tasks showed that mild acute stress decreased response time (i.e., increased response speed) without influencing accuracy or interference control. Further, computational modeling and mouse-tracking analyses indicated that these effects were due to faster motor action execution time for chosen actions. Intriguingly, however, cortisol responses were unrelated to any of the observed effects of mild stress. These results have implications for theories of stress and cognition, and highlight the importance of considering motor processes in understanding the effects of stress on cognitive task performance.",2019,"The results for both tasks showed that mild acute stress decreased response time (i.e., increased response speed) without influencing accuracy or interference control.","['107 participants to a mild acute stress or control condition', 'two selective attention tasks']",[],"['motor action execution time', 'cortisol relative', 'mild acute stress decreased response time', 'cortisol responses']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention (finding)'}]",[],"[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",107.0,0.0161148,"The results for both tasks showed that mild acute stress decreased response time (i.e., increased response speed) without influencing accuracy or interference control.","[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Shields', 'Affiliation': 'Department of Psychology, University of California, Davis, California, USA; Center for Neuroscience, University of California, Davis, California, USA. Electronic address: gsshields@ucdavis.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Rivers', 'Affiliation': 'Department of Psychology, University of British Columbia, Vancouver, CA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Ramey', 'Affiliation': 'Department of Psychology, University of California, Davis, California, USA; Center for Neuroscience, University of California, Davis, California, USA; Center for Mind and Brain, University of California, Davis, California, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Trainor', 'Affiliation': 'Department of Psychology, University of California, Davis, California, USA; Department of Animal Behavior, University of California, Davis, California, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Yonelinas', 'Affiliation': 'Department of Psychology, University of California, Davis, California, USA; Center for Neuroscience, University of California, Davis, California, USA; Center for Mind and Brain, University of California, Davis, California, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.06.001']
752,31008902,The Consequences of Foster Care Versus Institutional Care in Early Childhood on Adolescent Cardiometabolic and Immune Markers: Results From a Randomized Controlled Trial.,"OBJECTIVE
Children exposed to institutional rearing often exhibit problems across a broad array of developmental domains. We compared the consequences of long-term, high-quality foster care versus standard institution-based care, which began in early childhood on cardiometabolic and immune markers assessed at the time of adolescence.
METHODS
The Bucharest Early Intervention Project is a longitudinal investigation of children institutionalized during early childhood (ages 6 to 30 months at baseline) who were subsequently randomized to either high-quality foster care or continued institutional care. At the age of 16 years, 127 respondents participated in a biomarker collection protocol, including 44 institutionalized children randomly assigned to receive care as usual, 41 institutionalized children randomized to be removed from institutional care and placed in high-quality foster care in infancy, and a control group of 42 demographically matched children raised in biological families. Outcomes included body mass index (BMI), systolic and diastolic blood pressure, C-reactive protein, interleukin (IL)-6, IL-8, IL-10, tumor necrosis factor α, glycosylated hemoglobin A1c, and Epstein-Barr virus antibody titers.
RESULTS
Early institutional rearing was not associated with differences in cardiometabolic or immune markers. Randomization to foster care and age of placement into foster care were also unrelated to these markers, with the exception of BMI z-score, where children assigned to care as usual had lower BMI z-scores relative to children assigned to foster care (-0.23 versus 0.08, p = .06), and older age at placement was associated with lower BMI (β = -0.07, p = .03).
CONCLUSIONS
The impact of institutional rearing on measures of cardiometabolic health and immune system functioning is either absent or not evident until later in development. These findings provide new insights into the biological embedding of adversity and how it varies developmentally and across regulatory systems and adversity type.
CLINICAL TRIAL REGISTRATION
NCT00747396.",2019,Early institutional rearing was not associated with differences in cardiometabolic or immune markers.,"['children institutionalized during early childhood (ages 6 to 30 months at baseline) who were subsequently randomized to either', 'At the age of 16 years, 127 respondents participated in a biomarker collection protocol, including 44 institutionalized children randomly assigned to receive care as usual, 41 institutionalized children randomized to be removed from institutional care and placed in high-quality foster care in infancy, and a control group of 42 demographically matched children raised in biological families']","['high-quality foster care or continued institutional care', 'Foster Care Versus Institutional Care']","['body mass index (BMI), systolic and diastolic blood pressure, C-reactive protein, interleukin (IL)-6, IL-8, IL-10, tumor necrosis factor α, glycosylated hemoglobin A1c, and Epstein-Barr virus antibody titers', 'Adolescent Cardiometabolic and Immune Markers', 'cardiometabolic or immune markers', 'cardiometabolic health and immune system functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1292747', 'cui_str': 'Removes from'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0474653', 'cui_str': 'Epstein-Barr virus antibody titre measurement'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0162489', 'cui_str': 'Markers, Immunologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0020962', 'cui_str': 'Immune system'}, {'cui': 'C0031843', 'cui_str': 'function'}]",41.0,0.0738824,Early institutional rearing was not associated with differences in cardiometabolic or immune markers.,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Slopen', 'Affiliation': ""From the Department of Epidemiology and Biostatistics (Slopen), School of Public Health, University of Maryland; Department of Human Development and Quantitative Methodology (Tang, Fox), University of Maryland, College Park; Boston Children's Hospital (Nelson), Harvard Medical School, Boston; Harvard Graduate School of Education (Nelson), Cambridge, Massachusetts; Tulane University School of Medicine (Zeanah), New Orleans, Louisiana; Department of Anthropology and Institute for Policy Research (McDade), Northwestern University, Evanston, Illinois; and Department of Psychology (McLaughlin), Harvard University, Cambridge, Massachusetts.""}, {'ForeName': 'Alva', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': ''}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'McDade', 'Affiliation': ''}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'McLaughlin', 'Affiliation': ''}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000696']
753,31615840,Threat Memory Reminder Under Matrix Metalloproteinase 9 Inhibitor Doxycycline Globally Reduces Subsequent Memory Plasticity.,"Associative memory can be rendered malleable by a reminder. Blocking the ensuing reconsolidation process is suggested as a therapeutic target for unwanted aversive memories. Matrix metalloproteinase-9 (MMP-9) is required for structural synapse remodeling involved in memory consolidation. Inhibiting MMP-9 with doxycycline is suggested to attenuate human threat conditioning. Here, we investigated whether MMP-9 inhibition also interferes with threat memory reconsolidation. Male and female human participants ( N = 78) learned the association between two visual conditioned stimuli (CS + ) and a 50% chance of an unconditioned nociceptive stimulus (US), and between CS - and the absence of US. On day 7, one CS + was reminded without reinforcement 3.5 h after ingesting either 200 mg of doxycycline or placebo. On day 14, retention of CS memory was assessed under extinction by fear-potentiated startle. Contrary to our expectations, we observed a greater CS + /CS - difference in participants who were reminded under doxycycline compared with placebo. Participants who were reminded under placebo showed extinction learning during the retention test, which was not observed in the doxycycline group. There was no difference between the reminded and the nonreminded CS + in either group. In contrast, during relearning after the retention test, the CS + /CS - difference was more pronounced in the placebo group than in the doxycycline group. To summarize, a single dose of doxycycline before threat memory reminder appeared to have no specific impact on reconsolidation, but to globally impair extinction learning, and threat relearning, beyond drug clearance. SIGNIFICANCE STATEMENT Matrix metalloproteinase-9 inhibition appears to attenuate memory consolidation. It could also be a target for blocking reconsolidation. Here, we test this hypothesis in human threat conditioning. We find that doxycycline has no specific impact on a reminded cue, but confers a global reduction in extinction learning and threat learning beyond the clearance of the drug. This may point toward a more long-lasting impact of doxycycline treatment on memory plasticity.",2019,There was no difference between the reminded and the non-reminded CS+ in either group.,['male and female human participants'],"['doxycycline', 'visual conditioned stimuli (CS', 'placebo', 'Matrix metalloproteinase (MMP)-9', 'doxycycline, or placebo']","['memory plasticity', 'subsequent memory plasticity', 'extinction learning']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0165519', 'cui_str': '92-kDa Type IV Collagenase'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]",78.0,0.274568,There was no difference between the reminded and the non-reminded CS+ in either group.,"[{'ForeName': 'Dominik R', 'Initials': 'DR', 'LastName': 'Bach', 'Affiliation': 'Computational Psychiatry Research, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, 8032 Zurich, Switzerland, dominik.bach@uzh.ch.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Näf', 'Affiliation': 'Computational Psychiatry Research, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Deutschmann', 'Affiliation': 'Computational Psychiatry Research, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Shiva K', 'Initials': 'SK', 'LastName': 'Tyagarajan', 'Affiliation': 'Computational Psychiatry Research, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Neuroscience Centre Zurich, University of Zurich, 8057 Zurich, Switzerland.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.1285-19.2019']
754,31269008,Data-informed Intervention Improves Football Technique and Reduces Head Impacts.,"INTRODUCTION
Although sport participation is a key contributor to the physical and mental health of children and youth, exposure to subconcussive head impacts in football has raised concerns about safety for athletes.
PURPOSE
To demonstrate the efficacy of incorporating targeted football drills into a team's practice routine with the goal of improving players' technique and reduce exposure to subconcussive head impacts.
METHODS
Seventy high school football players (age, 16.4 ± 1.1 yr) were tested PRE season using a sport-specific functional assessment. Results from the testing were used to inform the design of a prepractice intervention aimed at improving tackling and blocking techniques while reducing exposure to head impacts. The assessment included drills which evaluated the players' ability to safely tackle, and block while simulating game-like situations. Testing was repeated at MID season (internal control) without an intervention, and again at POST season (experimental), after introduction of the prepractice intervention between these timepoints, administered twice weekly. All testing sessions were recorded, and subsequently reviewed by trained graders based on selected criteria defined by football coaches. A subset of 19 participants wore in-helmet accelerometers to assess the effectiveness of the intervention in decreasing head impacts during practice.
RESULTS
Significant improvements in blocking and tackling techniques were observed after the introduction of the intervention (P < 0.0001). Participating athletes also showed better techniques when evaluated in new game-like situations, postseason, providing evidence for proper acquisition and generalizability of these safer habits. Finally, frequency of head impacts (>15g) per practice was significantly reduced by ~30% after 1 month of training.
CONCLUSION
Our results suggest that data-informed methods can be used to improve coaching practices and promote safer play, which can have a positive public health impact moving forward.",2019,"RESULTS
Significant improvements in blocking and tackling techniques were observed following the introduction of the intervention (P<0.0001).",['Seventy high-school football players (age=16.4±1.1years) were tested PRE-season using a sport-specific functional assessment'],[],"['blocking and tackling techniques', 'frequency of head impacts']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}]",[],"[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",70.0,0.0289266,"RESULTS
Significant improvements in blocking and tackling techniques were observed following the introduction of the intervention (P<0.0001).","[{'ForeName': 'Allen A', 'Initials': 'AA', 'LastName': 'Champagne', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, ON, CANADA.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Distefano', 'Affiliation': 'School of Applied Child Psychology, McGill Connections Lab, Montréal, QC, CANADA.'}, {'ForeName': 'Marie-Michelle', 'Initials': 'MM', 'LastName': 'Boulanger', 'Affiliation': 'School of Applied Child Psychology, McGill Connections Lab, Montréal, QC, CANADA.'}, {'ForeName': 'Blaire', 'Initials': 'B', 'LastName': 'Magee', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, ON, CANADA.""}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Coverdale', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, ON, CANADA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gallucci', 'Affiliation': 'Toronto, ON, CANADA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Guskiewicz', 'Affiliation': 'Matthew Gfeller Sport-Related TBI Research Center, University of North Carolina-Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, ON, CANADA.""}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002046']
755,29608340,The impact of exercise on depressive symptoms in older Hispanic/Latino adults: results from the '¡Caminemos!' study.,"OBJECTIVES
We examined the prospective effects of an evidence-based exercise intervention on depressive symptoms in older Hispanics/Latinos and the potential synergistic effects (if any) of an attribution-retraining component to counter negative ascriptions to the aging process.
METHOD
We analyzed baseline, 1-, 12-, 24-month data collected from Hispanics/Latinos ≥ 60 years participating in an exercise intervention (""¡Caminemos!"") across 27 senior centers (N = 572). All participants were given 4 weekly 1-hour group-based exercise classes targeting strength training, endurance, balance and flexibility. In addition, they were randomly assigned to one of two conditions: a) treatment group-a 1-hour attribution retraining session where participants were taught that aging does not mean one inevitably becomes sedentary, or b) control group-generic health education. The Geriatric Depression Scale was used to assess depressive symptoms. Covariates included age, sex, education, income, marital status, acculturation, and number of chronic conditions.
RESULTS
In prospective analyses, participants in both trial arms displayed lower scores for depressive symptoms at 12- (β1 = -0.17, p = 0.04) and 24-months (β2 = -0.33, p < 0.001) when compared to baseline values.
CONCLUSION
Given expected growth of the older Hispanic/Latino adult population, exercise programs are a promising strategy in promoting favorable mental health.",2019,"24-months (β2 = -0.33, p < 0.001) when compared to baseline values.
","['27 senior centers (N = 572', 'older Hispanic/Latino adults', 'older Hispanics/Latinos']","['exercise', 'evidence-based exercise intervention', 'exercise intervention (""¡', 'treatment group-a 1-hour attribution retraining session where participants were taught that aging does not mean one inevitably becomes sedentary, or b) control group-generic health education']","['depressive symptoms', 'Geriatric Depression Scale']","[{'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018701'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}]",572.0,0.0599515,"24-months (β2 = -0.33, p < 0.001) when compared to baseline values.
","[{'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Hernandez', 'Affiliation': 'a School of Social Work , University of Illinois at Urbana-Champaign , Urbana , IL , United States.'}, {'ForeName': 'Flavia Cristina Drumond', 'Initials': 'FCD', 'LastName': 'Andrade', 'Affiliation': 'b Department of Kinesiology and Community Health , University of Illinois at Urbana-Champaign , Urbana , IL , United States.'}, {'ForeName': 'Lissette M', 'Initials': 'LM', 'LastName': 'Piedra', 'Affiliation': 'a School of Social Work , University of Illinois at Urbana-Champaign , Urbana , IL , United States.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Tabb', 'Affiliation': 'a School of Social Work , University of Illinois at Urbana-Champaign , Urbana , IL , United States.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'a School of Social Work , University of Illinois at Urbana-Champaign , Urbana , IL , United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sarkisian', 'Affiliation': 'c Department of Medicine , David Geffen School of Medicine at UCLA and VA Greater Los Angeles Geriatric Research Education and Clinical Center , Los Angeles , CA , United States.'}]",Aging & mental health,['10.1080/13607863.2018.1450833']
756,32102946,Vitamin D Pathway and Other Related Polymorphisms and Risk of Prostate Cancer: Results from the Prostate Cancer Prevention Trial.,"Vitamin D may influence prostate cancer risk, but evidence is inconsistent. We conducted a nested case-control study in the Prostate Cancer Prevention Trial (PCPT). Cases ( n = 1,128) and controls ( n = 1,205) were frequency matched on age, first-degree relative with prostate cancer, and PCPT treatment arm (finasteride/placebo); African-Americans were oversampled and case/control status was biopsy confirmed. We selected 21 SNPs in vitamin D-related genes (VDR, GC, C10orf88, CYP2R1, CYP24A1, CYP27B1, DHCR7 , and NADSYN1 ) to test genotype and genotype-treatment interactions in relation to prostate cancer. We also tested mean serum 25(OH)D differences by minor allele distributions and tested for serum 25(OH)D-genotype interactions in relation to prostate cancer risk. Log-additive genetic models (Bonferroni-corrected within genes) adjusted for age, body mass index, PSA, and family history of prostate cancer revealed a significant interaction between treatment arm and GC /rs222016 (finasteride OR = 1.37, placebo OR = 0.85; P interaction < 0.05), GC /rs222014 (finasteride OR = 1.36, placebo OR = 0.85; P interaction < 0.05), and CYP27B1 /rs703842 (finasteride OR = 0.76, placebo OR = 1.10; P interaction < 0.05) among Caucasians, and C10orf88 /rs6599638 (finasteride OR = 4.68, placebo OR = 1.39; P interaction < 0.05) among African-Americans. VDR/ rs1544410 and CYP27B1 /rs703842 had significant treatment interactions for high-grade disease among Caucasians (finasteride OR = 0.81, placebo OR = 1.40; P interaction < 0.05 and finasteride OR = 0.70, placebo OR = 1.28; P interaction < 0.05, respectively). Vitamin D-related SNPs influenced serum 25(OH)D, but gene-serum 25(OH)D effect modification for prostate cancer was marginally observed only for CYP24A1 /rs2248359. In conclusion, evidence that vitamin D-related genes or gene-serum 25(OH)D associations influence prostate cancer risk is modest. We found some evidence for gene-finasteride interaction effects for prostate cancer in Caucasians and African-Americans. Results suggest only minimal associations of vitamin D with total or high-grade prostate cancer.",2020,"finasteride OR=4.68, placebo OR=1.39, p-interaction<0.05) among African Americans.","['Cases (n=1,128) and controls (n=1,205) were frequency matched on age, first-degree relative with prostate cancer and', 'African-Americans were oversampled and', 'prostate cancer in Caucasians and African-Americans', 'African Americans']","['placebo', 'Vitamin D-related SNPs', 'PCPT treatment arm (finasteride/placebo', 'Vitamin D', 'finasteride', 'CYP27B1/rs703842 (finasteride OR=0.76, placebo', 'GC/rs222014 (finasteride']",[],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0000340', 'cui_str': '25-Hydroxyvitamin D2 1-hydroxylase'}]",[],1205.0,0.071002,"finasteride OR=4.68, placebo OR=1.39, p-interaction<0.05) among African Americans.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Torkko', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Cathee', 'Initials': 'C', 'LastName': 'Till', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Schenk', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Adrie', 'Initials': 'A', 'LastName': 'van Bokhoven', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus Santa Rosa Hospital-Medical Center, San Antonio, Texas.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington. mneuhous@fredhutch.org.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0413']
757,31168657,"Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension.","Romosozumab, which binds sclerostin, rebuilds the skeletal foundation before transitioning to antiresorptive treatment. This subgroup analysis of an international, randomized, double-blind study in postmenopausal women with osteoporosis showed efficacy and safety outcomes for romosozumab followed by denosumab in Japanese women were generally consistent with those for the overall population.
PURPOSE
In the international, randomized, double-blind, phase 3 FRActure study, in postmenopausal woMen with ostEoporosis (FRAME; NCT01575834), romosozumab followed by denosumab significantly improved bone mineral density (BMD) and reduced fracture risk. This report evaluates Japanese women in FRAME.
METHODS
Postmenopausal women with osteoporosis (T-score - 3.5 to - 2.5 at total hip or femoral neck) received romosozumab 210 mg or placebo subcutaneously monthly for 12 months, then each group received denosumab 60 mg subcutaneously every 6 months for 24 months. The key endpoint for Japanese women was BMD change. Other endpoints included new vertebral, clinical, and nonvertebral fracture; the subgroup analysis did not have adequate power to demonstrate statistically significant reductions.
RESULTS
Of 7180 enrolled subjects, 492 (6.9%) were Japanese (247 romosozumab, 245 placebo). BMD increases from baseline were greater (P < 0.001) for romosozumab-to-denosumab than placebo-to-denosumab at the lumbar spine (36 months, 12.7%), total hip (4.2%), and femoral neck (4.1%). Fracture risk was lower through 36 months for romosozumab-to-denosumab vs placebo-to-denosumab for new vertebral (1.7% vs 4.5%; relative risk reduction (RRR) 63%, P = 0.070), clinical (3.2% vs 7.3%; RRR 53%, P = 0.072), nonvertebral (2.8% vs 6.1%; RRR 50%, P = 0.12), and all other fracture types evaluated. Rates of adverse events and positively adjudicated serious cardiovascular events were generally balanced between groups.
CONCLUSIONS
Efficacy and safety for romosozumab-to-denosumab were similar between Japanese women and the overall population. The sequence of romosozumab to rebuild the skeletal foundation before transitioning to antiresorptive treatment with denosumab is a promising regimen for Japanese postmenopausal women with osteoporosis at high risk of fracture.",2019,"Fracture risk was lower through 36 months for romosozumab-to-denosumab vs placebo-to-denosumab for new vertebral (1.7% vs 4.5%; relative risk reduction (RRR) 63%, P = 0.070), clinical (3.2% vs 7.3%; RRR 53%, P = 0.072), nonvertebral (2.8% vs 6.1%; RRR 50%, P = 0.12), and all other fracture types evaluated.","['Japanese women in FRAME', 'Japanese women', 'Of 7180 enrolled subjects, 492 (6.9%) were Japanese (247 romosozumab, 245 placebo', 'Japanese women and the overall population', 'Postmenopausal women with osteoporosis (T-score -\u20093.5 to -\u20092.5 at total hip or femoral neck', 'Japanese postmenopausal women with osteoporosis at high risk of fracture', 'postmenopausal woMen with ostEoporosis (FRAME', 'postmenopausal women with osteoporosis']","['placebo', 'romosozumab', 'romosozumab-to-denosumab', 'romosozumab 210\xa0mg or placebo', 'denosumab']","['bone mineral density', 'bone mineral density (BMD) and reduced fracture risk', 'total hip', 'femoral neck', 'Fracture risk', 'BMD', 'efficacy and safety outcomes', 'nonvertebral', 'Rates of adverse events and positively adjudicated serious cardiovascular events']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C3661283'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661283'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",7180.0,0.285628,"Fracture risk was lower through 36 months for romosozumab-to-denosumab vs placebo-to-denosumab for new vertebral (1.7% vs 4.5%; relative risk reduction (RRR) 63%, P = 0.070), clinical (3.2% vs 7.3%; RRR 53%, P = 0.072), nonvertebral (2.8% vs 6.1%; RRR 50%, P = 0.12), and all other fracture types evaluated.","[{'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Miyauchi', 'Affiliation': 'Miyauchi Medical Center, Osaka, Japan. akimiyauchi0129@gmail.com.'}, {'ForeName': 'Rajani V', 'Initials': 'RV', 'LastName': 'Dinavahi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daria B', 'Initials': 'DB', 'LastName': 'Crittenden', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Judy C', 'Initials': 'JC', 'LastName': 'Maddox', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hamaya', 'Affiliation': 'Amgen Astellas BioPharma K.K., Tokyo, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Amgen Astellas BioPharma K.K., Tokyo, Japan.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Shimauchi', 'Affiliation': 'Amgen Astellas BioPharma K.K., Tokyo, Japan.'}]",Archives of osteoporosis,['10.1007/s11657-019-0608-z']
758,30448936,The influence of exercise training dose on fasting acylated ghrelin concentration in older women.,"This study investigated if exercise dose affected acylated ghrelin response to exercise training, and how body weight or fat mass changes might affect the responses. Non-obese older women (n = 49) were randomly assigned to 4-month moderate-intensity aerobic exercise of one of two doses (8 or 14 kcal kg -1 body weight weekly). Following exercise training, fasting acylated ghrelin concentrations changed differently between the two groups (p for group × time interaction = 0.050). It decreased in the moderate-dose (Cohen's d = 0.52, p = 0.019), but did not change in the low-dose exercise group. Adjustment for weight or fat changes did not affect these results. Therefore, exercise training dose can have specific effects on acylated ghrelin that are not dependent on weight or fat loss. However, whether the different acylated ghrelin changes are associated with differing degree of subsequent weight maintenance worth further investigation.",2019,"It decreased in the moderate-dose (Cohen's d = 0.52, p = 0.019), but did not change in the low-dose exercise group.","['Non-obese older women (n\u2009=\u200949', 'older women']","['exercise training', 'moderate-intensity aerobic exercise']","['weight or fat changes', 'fasting acylated ghrelin concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",49.0,0.0275274,"It decreased in the moderate-dose (Cohen's d = 0.52, p = 0.019), but did not change in the low-dose exercise group.","[{'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Bowyer', 'Affiliation': 'Department of Exercise Science, University of South Carolina, PHRC 301, 921 Assembly St., Columbia, SC, 29208, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Carson', 'Affiliation': 'Department of Exercise Science, University of South Carolina, PHRC 301, 921 Assembly St., Columbia, SC, 29208, USA.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Exercise Science, University of South Carolina, PHRC 301, 921 Assembly St., Columbia, SC, 29208, USA.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Exercise Science, University of South Carolina, PHRC 301, 921 Assembly St., Columbia, SC, 29208, USA. xwang@sc.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-018-9990-z']
759,31264183,Building a physical activity intervention into clinical care for breast and colorectal cancer survivors in Wisconsin: a randomized controlled pilot trial.,"BACKGROUND
Cancer survivorship care plans (""care plans"") often recommend an active lifestyle yet are rarely accompanied by programs to help patients enact the prescribed behavior change. As a step towards bridging this gap, this trial tested the feasibility of augmenting care planning with a multi-level physical activity intervention.
METHODS
Breast and colorectal cancer survivors were enrolled alongside a self-selected support partner (e.g., spouse, friend). Survivors received a care plan alone (comparison group) versus one augmented with a 12-week physical activity module (intervention group). For the intervention group dyads, both members received a multi-component program including Fitbit trackers, with the survivor's Fitbit linked to his/her electronic health record (EHR). Treating clinicians received periodic updates regarding the survivors' physical activity. The primary outcome was ActiGraph-measured physical activity, analyzed using mixed models. Feedback questionnaires were administered to participants and clinicians at 12 weeks.
RESULTS
Survivors (n = 50) were 54.4 ± 11.2 years of age and 2.0 ± 1.5 years post-diagnosis. Survivors in the intervention group increased moderate-to-vigorous-intensity physical activity (MVPA) by 69 ± 84 min/week vs. a 20 ± 71 min/week decrease in the comparison group (p = .001). Likewise, daily steps increased by 1470 ± 1881 vs. a 398 ± 1751 decrease (P = .002). Among responding clinicians, 100% looked at survivors' activity data within the EHR at least once and 80% said it provided insight into their patients' lifestyles.
CONCLUSIONS
Augmenting a standard care plan with a multi-level, technology-based intervention increased physical activity among cancer survivors.
IMPLICATIONS FOR CANCER SURVIVORS
Technology-based approaches, including activity trackers, can be used by individuals to work towards an active lifestyle after cancer.",2019,Survivors in the intervention group increased moderate-to-vigorous-intensity physical activity (MVPA) by 69 ± 84 min/week vs. a 20 ± 71 min/week decrease in the comparison group (p = .001).,"['Survivors (n\u2009=\u200950) were 54.4\u2009±\u200911.2\xa0years of age and 2.0\u2009±\u20091.5\xa0years post-diagnosis', 'breast and colorectal cancer survivors in Wisconsin', 'Breast and colorectal cancer survivors were enrolled alongside a self-selected support partner (e.g., spouse, friend']","['standard care plan with a multi-level, technology-based intervention', 'physical activity intervention', ""multi-component program including Fitbit trackers, with the survivor's Fitbit linked to his/her electronic health record (EHR"", 'care plan alone (comparison group) versus one augmented with a 12-week physical activity module (intervention group']","['ActiGraph-measured physical activity', 'physical activity', 'moderate-to-vigorous-intensity physical activity (MVPA']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517531', 'cui_str': '11.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.0651691,Survivors in the intervention group increased moderate-to-vigorous-intensity physical activity (MVPA) by 69 ± 84 min/week vs. a 20 ± 71 min/week decrease in the comparison group (p = .001).,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cadmus-Bertram', 'Affiliation': 'Department of Kinesiology, University of Wisconsin - Madison, 2000 Observatory Drive, Madison, WI, 53706, USA. lisa.bertram@wisc.edu.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'Carbone Comprehensive Cancer Center, University of Wisconsin - Madison, Madison, WI, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Sesto', 'Affiliation': 'Carbone Comprehensive Cancer Center, University of Wisconsin - Madison, Madison, WI, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'Carbone Comprehensive Cancer Center, University of Wisconsin - Madison, Madison, WI, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Van Remortel', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin - Madison, Madison, WI, USA.'}, {'ForeName': 'Preshita', 'Initials': 'P', 'LastName': 'Date', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin - Madison, Madison, WI, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00778-6']
760,31342329,Integrating a Medical Home in an Outpatient Dialysis Setting: Effects on Health-Related Quality of Life.,"BACKGROUND
Integrating primary care has been proposed to reduce fragmented care delivery for patients with complex medical needs. Because of their high rates of morbidity, healthcare use, and mortality, patients with end-stage kidney disease (ESKD) may benefit from increased access to a primary care medical home.
OBJECTIVE
To evaluate the effect of integrating a primary care medical home on health-related quality of life (HRQOL) for patients with ESKD receiving chronic hemodialysis.
DESIGN
Before-after intervention trial with repeated measures at two Chicago dialysis centers.
PARTICIPANTS
Patients receiving hemodialysis at either of the two centers.
INTERVENTION
To the standard hemodialysis team (nephrologist, nurse, social worker, dietitian), we added a primary care physician, a pharmacist, a nurse coordinator, and a community health worker. The intervention took place from January 2015 through August 2016.
MAIN MEASURES
Health-related quality of life, using the Kidney Disease Quality of Life (KDQOL) measures.
KEY RESULTS
Of 247 eligible patients, 175 (71%) consented and participated; mean age was 54 years; 55% were men and 97% were African American or Hispanic. In regression analysis adjusted for individual visits with the medical home providers and other factors, there were significant improvements in four of five KDQOL domains: at 12 and 18 months, the Mental Component Score improved from baseline (adjusted mean 49.0) by 2.64 (p = 0.01) and 2.96 (p = 0.007) points, respectively. At 6 and 12 months, the Symptoms domain improved from baseline (adjusted mean = 77.0) by 2.61 (p = 0.02) and 2.35 points (p = 0.05) respectively. The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively. The Physical Component Score improved at 6 months only.
CONCLUSIONS
Integrating primary care and enhancing care coordination in two dialysis facilities was associated with improvements in HRQOL among patients with ESKD who required chronic hemodialysis.",2019,"The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively.","['Patients receiving hemodialysis at either of the two centers', '175 (71%) consented and participated; mean age was 54\xa0years; 55% were men and 97% were African American or Hispanic', 'patients with ESKD who required chronic hemodialysis', 'patients with end-stage kidney disease (ESKD', 'patients with ESKD receiving chronic hemodialysis', '247 eligible patients', 'patients with complex medical needs']",[],"['Physical Component Score', 'Symptoms domain', 'Health-related quality of life, using the Kidney Disease Quality of Life (KDQOL) measures', 'Health-Related Quality of Life', 'Mental Component Score', 'health-related quality of life (HRQOL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",247.0,0.0347094,"The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively.","[{'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Hynes', 'Affiliation': 'College of Public Health and Human Sciences and Center for Genome Research and Biocomputing, Oregon State University, Corvallis, OR, USA. hynesd@oregonstate.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fitzgibbon', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Porter', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Ifeanyi B', 'Initials': 'IB', 'LastName': 'Chukwudozie', 'Affiliation': 'Office of Community Engaged Research and Implementation Science, University of Illinois Cancer Center, Chicago, IL, USA.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Arruda', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Illinois at Chicago, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05154-9']
761,31483785,A cluster-randomized crossover trial of organic diet impact on biomarkers of exposure to pesticides and biomarkers of oxidative stress/inflammation in primary school children.,"Despite suggestive observational epidemiology and laboratory studies, there is limited experimental evidence regarding the effect of organic diet on human health. A cluster-randomized 40-day-organic (vs. 40-day-conventional) crossover trial was conducted among children (11-12 years old) from six schools in Cyprus. One restaurant provided all organic meals, and adherence to the organic diet intervention was measured by parent-provided diet questionnaire/diary data. Biomarkers of pyrethroid and neonicotinoid pesticide exposures were measured using tandem mass spectrometry, and oxidative stress/inflammation (OSI) biomarkers using immunoassays or spectrophotometry. Associations were assessed using mixed-effect regression models including interactions of treatment with time. Seventy-two percent of neonicotinoid biomarkers were non-detectable and modeled as binary (whether detectable). In post-hoc analysis, we considered the outcome of age-and-sex-standardized BMI. Multiple comparisons were handled using Benjamini-Hochberg correction for 58 regression parameters. Outcome data were available for 149 children. Children had lower pesticide exposures during the organic period (pyrethroid geometric mean ratio, GMR = 0.297; [95% confidence interval (95% CI): 0.237, 0.373], Q-value<0.05); odds for detection of neonicotinoids (OR = 0.651; [95% CI: 0.463, 0.917), Q-value<0.05); and decreased OSI biomarker 8-OHdG (GMR = 0.888; [95% CI: 0.808, 0.976], Q-value<0.05). An initial increase was followed by a countervailing decrease over time in the organic period for OSI biomarkers 8-iso-PGF2a and MDA. BMI z-scores were lower at the end of the organic period (β = -0.131; [95% CI: 0.179, -0.920], Q-value<0.05). Energy intake during the conventional period was reported to be higher than the recommended reference levels. The organic diet intervention reduced children's exposure to pyrethroid and neonicotinoid pesticides and, over time lowered biomarkers of oxidative stress/inflammation (8-iso-PGF2a, 8-OHdG and MDA). The several-week organic diet intervention also reduced children's age-and-sex-standardized BMI z-scores, but causal inferences regarding organic diet's physiological benefits are limited by the confounding of the organic diet intervention with caloric intake reduction and possible lifestyle changes during the trial. Trial registration: This trial is registered with ClinicalTrials.gov, number: NCT02998203.",2019,"Children had lower pesticide exposures during the organic period (pyrethroid geometric mean ratio, GMR = 0.297; [95% confidence interval (95% CI): 0.237, 0.373], Q-value<0.05); odds for detection of neonicotinoids (OR = 0.651; [95% CI: 0.463, 0.917), Q-value<0.05); and decreased OSI biomarker 8-OHdG (GMR = 0.888; [95% CI: 0.808, 0.976], Q-value<0.05).","['children (11-12 years old) from six schools in Cyprus', '149 children', 'primary school children']","['organic diet', 'organic diet intervention']","['BMI z-scores', 'OSI biomarker 8-OHdG', 'oxidative stress/inflammation (8-iso-PGF2a, 8-OHdG and MDA', 'lower pesticide exposures', 'Energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0031253', 'cui_str': 'Pesticides'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",149.0,0.138689,"Children had lower pesticide exposures during the organic period (pyrethroid geometric mean ratio, GMR = 0.297; [95% confidence interval (95% CI): 0.237, 0.373], Q-value<0.05); odds for detection of neonicotinoids (OR = 0.651; [95% CI: 0.463, 0.917), Q-value<0.05); and decreased OSI biomarker 8-OHdG (GMR = 0.888; [95% CI: 0.808, 0.976], Q-value<0.05).","[{'ForeName': 'Konstantinos C', 'Initials': 'KC', 'LastName': 'Makris', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Konstantinou', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Xanthi D', 'Initials': 'XD', 'LastName': 'Andrianou', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Charisiadis', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Kyriacou', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland, United Kingdom.'}, {'ForeName': 'Matthew O', 'Initials': 'MO', 'LastName': 'Gribble', 'Affiliation': 'Department of Environmental Health, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'Costas A', 'Initials': 'CA', 'LastName': 'Christophi', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}]",PloS one,['10.1371/journal.pone.0219420']
762,30984388,Using pens as an incentive for trial recruitment of older adults: An embedded randomised controlled trial.,"Background : Meeting recruitment targets for randomised controlled trials is challenging. This trial evaluated the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults into a randomised controlled trial. Methods : This trial was embedded within the Occupational Therapist Intervention Study, a falls-prevention randomised controlled trial. Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices, were randomised to either not receive a pen (n = 1295) or receive a pen (n = 648) with their invitation pack, using a 2:1 ratio. The primary outcome was the likelihood of being randomised, and therefore fully recruited, to the host trial. To be randomised to the host trial, participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar. Secondary outcomes were: the likelihood of returning (and time to return) a screening form; being eligible for the host trial; and remaining in the trial for at least 3 months. Results : The likelihood of being randomised to the host trial did not differ between the pen group (4.5%) and no pen group (4.3%; odds ratio 1.04; 95% confidence interval: 0.65 to 1.67; p = 0.86). There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. Conclusion : Pens may not be an effective incentive for the recruitment of older adults into randomised controlled trials, though future trials are required. Registration: ISRCTN22202133; SWAT 37.",2019,"There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. ","['Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices', 'participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar', 'older adults']",[' '],['likelihood of returning (and time to return) a screening form; being eligible for the host trial'],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Documents'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",648.0,0.391683,"There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. ","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Whiteside', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Flett', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cockayne', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rodgers', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.18300.1']
763,31034032,Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial.,"Importance
Results show the short-term risk of hemorrhage in treating patients with acute transient ischemic attack (TIA) or minor acute ischemic stroke (AIS) with clopidogrel plus aspirin or aspirin alone.
Objective
To characterize the frequency and kinds of major hemorrhages in the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial.
Design, Setting, and Participants
This secondary analysis of the POINT randomized, double-blind clinical trial conducted in 10 countries in North America, Europe, and Australasia included patients with high-risk TIA or minor AIS who were randomized within 12 hours of symptom onset and followed up for 90 days. The total enrollment, which occurred from May 28, 2010, through December 17, 2017, was 4881 and constituted the intention-to-treat group; 4819 (98.7%) were included in the as-treated analysis group. The primary safety analyses were as-treated, classifying patients based on study drug actually received. Intention-to-treat analyses were performed as secondary analyses. Data were analyzed in April 2018.
Interventions
Patients were assigned to receive clopidogrel (600 mg loading dose on day 1 followed by 75 mg daily for days 2-90) or placebo; all patients also received open-label aspirin, 50 to 325 mg/d.
Main Outcomes and Measures
The primary safety outcome was all major hemorrhages. Other safety outcomes included minor hemorrhages.
Results
A total of 269 sites worldwide randomized 4881 patients (median age, 65.0 years [interquartile range, 55-74 years]; 2195 women [45.0%]); the primary results have been published previously. In the as-treated analyses, major hemorrhage occurred in 21 patients (0.9%) receiving clopidogrel plus aspirin and 6 (0.2%) in the aspirin alone group (hazard ratio, 3.57; 95% CI, 1.44-8.85; P = .003; number needed to harm, 159). There were 4 fatal hemorrhages (0.1%; 3 in the clopidogrel plus aspirin group and 1 in the aspirin alone group); 3 of the 4 were intracranial. There were 7 intracranial hemorrhages (0.1%); 5 were in the clopidogrel plus aspirin group and 2 in the aspirin plus placebo group. The most common location of major hemorrhages was in the gastrointestinal tract.
Conclusions and Relevance
The risk for major hemorrhages in patients receiving either clopidogrel plus aspirin or aspirin alone after TIA or minor AIS was low. Nevertheless, treatment with clopidogrel plus aspirin increased the risk of major hemorrhages over aspirin alone from 0.2% to 0.9%.
Trial Registration
ClinicalTrials.gov identifier: NCT00991029.",2019,The risk for major hemorrhages in patients receiving either clopidogrel plus aspirin or aspirin alone after TIA or minor AIS was low.,"['After Transient Ischemic Attack or Minor Ischemic Stroke', 'patients with acute transient ischemic attack (TIA) or minor acute ischemic stroke (AIS) with', 'A total of 269 sites worldwide randomized 4881 patients (median age, 65.0 years [interquartile range, 55-74 years]; 2195 women [45.0', '10 countries in North America, Europe, and Australasia included patients with high-risk TIA or minor AIS who were randomized within 12 hours of symptom onset and followed up for 90 days']","['clopidogrel plus aspirin or aspirin', 'placebo', 'clopidogrel plus aspirin', 'aspirin', 'open-label aspirin', 'aspirin plus placebo', 'Aspirin Alone', 'Clopidogrel and Aspirin', 'clopidogrel']","['major hemorrhages', 'risk of major hemorrhages', 'intracranial hemorrhages', 'fatal hemorrhages', 'major hemorrhage']","[{'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0282279', 'cui_str': 'Oceania'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",4881.0,0.321234,The risk for major hemorrhages in patients receiving either clopidogrel plus aspirin or aspirin alone after TIA or minor AIS was low.,"[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Tillman', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, University of Texas at Austin, Austin.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Farrant', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2019.0932']
764,31034300,"FLT3 Inhibitor Maintenance After Allogeneic Transplantation: Is a Placebo-Controlled, Randomized Trial Ethical?",,2019,,[],"['Placebo', 'FLT3 Inhibitor Maintenance', 'Allogeneic Transplantation']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic Grafting'}]",[],,0.106653,,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Levis', 'Affiliation': '1 Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Yi-Bin', 'Initials': 'YB', 'LastName': 'Chen', 'Affiliation': '2 Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hamadani', 'Affiliation': '3 Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': '3 Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': '1 Johns Hopkins University, Baltimore, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00321']
765,31079082,Effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial protocol.,"INTRODUCTION
The virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.
METHODS AND ANALYSIS
A consecutive sample of 384 stroke survivor-caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors' SE in self-management and survivors' and caregivers' HRQoL. Secondary outcomes include survivors' performance of self-management behaviours, depression and social participation; and caregivers' coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6 months after commencing the intervention. Survivors' and caregivers' satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors' emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred.
DISCUSSION
The results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service.
ETHICS AND DISSEMINATION
This protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.
TRIAL REGISTRATION NUMBER
ChiCTR1800016101; Pre-results.",2019,"This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.
","['A consecutive sample of 384 stroke survivor-caregiver dyads will be recruited from four hospitals', 'community-dwelling stroke survivors and caregivers']","['virtual multidisciplinary stroke care clinic', 'intervention group will receive usual care plus the VMSCC service']","[""Survivors' emergency admissions and length of hospital stay"", 'average total cost incurred', ""survivors' SE in self-management and survivors' and caregivers' HRQoL. Secondary outcomes include survivors' performance of self-management behaviours, depression and social participation; and caregivers' coping strategies, satisfaction with caring and depression"", ""survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay"", 'Effectiveness and cost-effectiveness']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.135411,"This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.
","[{'ForeName': 'Janita Pak Chun', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Suzanne Hoi Shan', 'Initials': 'SHS', 'LastName': 'Lo', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Vivian Wing Yan', 'Initials': 'VWY', 'LastName': 'Lee', 'Affiliation': 'School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Edward Wai Ching', 'Initials': 'EWC', 'LastName': 'Shum', 'Affiliation': 'Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Zevari Sheung Sheung', 'Initials': 'ZSS', 'LastName': 'Hung', 'Affiliation': 'Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Vincent Chung Tong', 'Initials': 'VCT', 'LastName': 'Mok', 'Affiliation': 'Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Elaine Kee Chen', 'Initials': 'EKC', 'LastName': 'Siow', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jessica Yuet Ling', 'Initials': 'JYL', 'LastName': 'Ching', 'Affiliation': 'Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Simon Kwun Yu', 'Initials': 'SKY', 'LastName': 'Lam', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jonas Hon Ming', 'Initials': 'JHM', 'LastName': 'Yeung', 'Affiliation': 'Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, Hong Kong.'}, {'ForeName': 'Siu Hung', 'Initials': 'SH', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, North District Hospital, Hong Kong.'}, {'ForeName': 'Alexander Yuk Lun', 'Initials': 'AYL', 'LastName': 'Lau', 'Affiliation': 'Hong Kong Institute of Integrative Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}]",BMJ open,['10.1136/bmjopen-2018-026500']
766,31079083,"Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial.","INTRODUCTION
Doin therapy is a manual therapy used in Korean rehabilitation medicine. Recently, the use of acupuncture with Doin has increased in clinics and clinical trials have demonstrated its effects. However, well-designed studies examining the efficacy and cost-effectiveness of acupuncture with Doin therapy are rare.
METHODS AND ANALYSIS
This multicentre, assessor-blinded, randomised controlled trial with two parallel groups aims to evaluate the clinical effects and cost-effectiveness of acupuncture with Doin therapy. A total of 124 patients (with a neck pain duration of 6 months or longer and a Numeric Rating Scale ≥5) will be recruited at five Korean medicine hospitals. Patients will be randomly allocated to acupuncture with Doin therapy (n=62) and acupuncture alone (n=62) for 5 weeks of treatment. This study will be carried out with outcome assessor and statistician blinding. The primary outcome measure will consist of improvement in neck pain using the Visual Analogue Scale at 6 weeks. The secondary outcomes including measures of pain, functional disability, health-related quality of life and economic evaluation will be conducted at 6 weeks, and 3, 6, 9 and 12 months after treatment ETHICS AND DISSEMINATION: The project is approved by the Institutional Review Board (IRB) of the Jaseng Hospital of Korean Medicine and the Kyung Hee University Korean Medicine Hospital at Gangdong. Dissemination will occur after the findings from this study are published in other peer reviewed journals.
TRIAL REGISTRATION NUMBERS
NCT03558178; KCT0003068; Pre-results.",2019,A total of 124 patients (with a neck pain duration of 6 months or longer and a Numeric Rating Scale ≥5) will be recruited at five Korean medicine hospitals.,"['124 patients (with a neck pain duration of 6\u2009months or longer and a Numeric Rating Scale ≥5)\u2009will be recruited at five Korean medicine hospitals', 'chronic neck pain', 'Jaseng Hospital of Korean Medicine and the Kyung Hee University Korean Medicine Hospital at Gangdong', 'Korean rehabilitation medicine']","['acupuncture alone', 'acupuncture', 'acupuncture with Doin therapy']","['measures of pain, functional disability, health-related quality of life and economic evaluation', 'clinical effects and cost-effectiveness', 'neck pain using the Visual Analogue Scale', 'Effectiveness and cost-effectiveness', 'efficacy and cost-effectiveness']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",124.0,0.223349,A total of 124 patients (with a neck pain duration of 6 months or longer and a Numeric Rating Scale ≥5) will be recruited at five Korean medicine hospitals.,"[{'ForeName': 'Sook-Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.'}, {'ForeName': 'Jinho', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.'}, {'ForeName': 'Me-Riong', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': 'Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Heung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Koh-Woon', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.'}]",BMJ open,['10.1136/bmjopen-2018-026632']
767,30930034,Evaluation of a plasticity-based cognitive training program in schizophrenia: Results from the eCaesar trial.,"OBJECTIVE
Cognitive impairment in schizophrenia is a core feature of the disorder. Computerized cognitive training has shown promise in pilot studies. A 26-week randomized blinded placebo-controlled trial was conducted to investigate the effect of a novel computerized cognitive training program on cognitive and functional capacity outcomes.
METHOD
The study followed MATRICS guidelines for the evaluation of interventions designed to improve cognitive function in schizophrenia. Participants (N = 150) were randomized to experimental (computerized cognitive training in a game-like format) or active control (computer games) groups. Training was conducted in-clinic, with an intended training schedule of 5 days per week, 1 h per day, for 26 weeks. Co-primary outcome measures were the MATRICS Consensus Cognitive Battery (MCCB) composite score and the UCSD Performance-Based Skills Assessment (UPSA-2) total score, secondary outcome measures included the Cognitive Assessment Interview (CAI) and the Short-Form-12 Mental Composite Score (SF-12 MCS). Target engagement was assessed with task-learning based assessment.
RESULTS
At baseline, the groups were well matched. No significant effect of the experimental treatment was seen on the primary or secondary outcome measures compared to the active control. Review of the task learning/target engagement data suggested inadequate target engagement.
CONCLUSIONS
Results do not support a cognitive or functional capacity benefit from this implementation of a computerized cognitive training program in people with schizophrenia. In future trials, careful consideration is merited of the assessment of task learning/target engagement, the effects of making the cognitive training game-like on motivation, and the implicit effects of trial requirements on participant selection.",2019,No significant effect of the experimental treatment was seen on the primary or secondary outcome measures compared to the active control.,"['people with schizophrenia', 'schizophrenia', 'Participants (N\u202f=\u202f150']","['placebo', 'novel computerized cognitive training program', 'Computerized cognitive training', 'plasticity-based cognitive training program', 'computerized cognitive training program', 'experimental (computerized cognitive training in a game-like format) or active control (computer games']","['cognitive and functional capacity outcomes', 'Consensus Cognitive Battery (MCCB) composite score and the UCSD Performance-Based Skills Assessment (UPSA-2) total score, secondary outcome measures included the Cognitive Assessment Interview (CAI) and the Short-Form-12 Mental Composite Score (SF-12 MCS']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",150.0,0.113283,No significant effect of the experimental treatment was seen on the primary or secondary outcome measures compared to the active control.,"[{'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Mahncke', 'Affiliation': 'Posit Science, United States of America. Electronic address: henry.mahncke@positscience.com.'}, {'ForeName': 'Sarah-Jane', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Posit Science, United States of America.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Rose', 'Affiliation': 'Posit Science, United States of America.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stasio', 'Affiliation': 'Posit Science, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Buckley', 'Affiliation': 'Virginia Commonwealth University, United States of America.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Caroff', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, The Perelman School of Medicine, University of Pennsylvania, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Duncan', 'Affiliation': 'Atlanta Veterans Affairs Medical Center, Emory University, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Yasmin', 'Affiliation': 'Palo Alto Veterans Affairs Medical Center, United States of America.'}, {'ForeName': 'L Fredrik', 'Initials': 'LF', 'LastName': 'Jarskog', 'Affiliation': 'University of North Carolina at Chapel Hill, United States of America.'}, {'ForeName': 'J Steven', 'Initials': 'JS', 'LastName': 'Lamberti', 'Affiliation': 'University of Rochester, United States of America.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Nuechterlein', 'Affiliation': 'University of California, Los Angeles, United States of America.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Strassnig', 'Affiliation': 'University of Miami, United States of America.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Velligan', 'Affiliation': 'University of Texas Health Science Center in Austin, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ventura', 'Affiliation': 'University of California, Los Angeles, United States of America.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Walker', 'Affiliation': 'Duke University, United States of America.'}, {'ForeName': 'T Scott', 'Initials': 'TS', 'LastName': 'Stroup', 'Affiliation': 'Columbia University, United States of America.'}, {'ForeName': 'Richard S E', 'Initials': 'RSE', 'LastName': 'Keefe', 'Affiliation': 'Duke University, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2019.03.006']
768,30932154,Do graphic health warning labels on cigarette packages deter purchases at point-of-sale? An experiment with adult smokers.,"This experiment tested whether the presence of graphic health warning labels on cigarette packages deterred adult smokers from purchasing cigarettes at retail point-of-sale (POS), and whether individual difference variables moderated this relationship. The study was conducted in the RAND StoreLab (RSL), a life-sized replica of a convenience store that was developed to evaluate how changing POS tobacco advertising influences tobacco use outcomes during simulated shopping experiences. Adult smokers (n = 294; 65% female; 59% African-American; 35% White) were assigned randomly to shop in the RSL under one of two experimental conditions: graphic health warning labels present on cigarette packages versus absent on cigarette packages. Cigarette packages in both conditions were displayed on a tobacco power wall, which was located behind the RSL cashier counter. Results revealed that the presence of graphic health warning labels did not influence participants' purchase of cigarettes as a main effect. However, nicotine dependence acted as a significant moderator of experimental condition. Graphic health warning labels reduced the chances of cigarette purchases for smokers lower in nicotine dependence but had no effect on smokers higher in dependence.",2019,Graphic health warning labels reduced the chances of cigarette purchases for smokers lower in nicotine dependence but had no effect on smokers higher in dependence.,"['cigarette packages deterred adult smokers from purchasing cigarettes at retail point-of-sale (POS', 'adult smokers', 'Adult smokers (n = 294; 65% female; 59% African-American; 35% White']","['graphic health warning labels', 'graphic health warning labels present on cigarette packages versus absent on cigarette packages']",[],"[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}]",[],294.0,0.0191404,Graphic health warning labels reduced the chances of cigarette purchases for smokers lower in nicotine dependence but had no effect on smokers higher in dependence.,"[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Shadel', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave., Suite 600, Pittsburgh, PA, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Martino', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave., Suite 600, Pittsburgh, PA, USA.'}, {'ForeName': 'Claude M', 'Initials': 'CM', 'LastName': 'Setodji', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave., Suite 600, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dunbar', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave., Suite 600, Pittsburgh, PA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Scharf', 'Affiliation': 'Department of Psychology, Lakehead University, 955 Oliver Rd., Thunder Bay, Ontario, Canada.'}, {'ForeName': 'Kasey G', 'Initials': 'KG', 'LastName': 'Creswell', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, 5000 Forbes Ave.,Pittsburgh, PA, USA.'}]",Health education research,['10.1093/her/cyz011']
769,30758491,Effect of Augmenting Standard Care for Military Personnel With Brief Caring Text Messages for Suicide Prevention: A Randomized Clinical Trial.,"Importance
Accessible and cost-effective interventions for suicidality are needed to address high rates of suicidal behavior among military service members. Caring Contacts are brief periodic messages that express unconditional care and concern and have been previously shown to prevent suicide deaths, attempts, ideation, and hospitalizations.
Objective
To test the effectiveness of augmenting standard military health care with Caring Contacts delivered via text message to reduce suicidal thoughts and behaviors over 12 months.
Design, Setting, and Participants
This randomized clinical trial was conducted at 3 military installations in the southern and western United States. Soldiers and Marines identified as being at risk of suicide were recruited between April 2013 and September 2016. The final follow-up was in September 2017.
Interventions
Both groups received standard care, and the Caring Contacts group also received consisted of 11 text messages delivered on day 1, at week 1, at months 1, 2, 3, 4, 6, 8, 10, and 12, and on participants' birthdays.
Main Outcomes and Measures
Primary outcomes were current suicidal ideation and suicide risk incidents (hospitalization or medical evacuation). Secondary outcomes were worst-point suicidal ideation, emergency department visits, and suicide attempts. Suicidal ideation was measured by the Scale for Suicide Ideation, suicide risk incidents, and emergency department visits by the Treatment History Interview; attempted suicide was measured by the Suicide Attempt Self-Injury Count.
Results
Among 658 randomized participants (329 randomizely assigned to each group), data were analyzed for 657 individuals (mean [SD] age, 25.2 [6.1] years; 539 men [82.0%]). All participants reported suicidal ideation at baseline, and 291 (44.3%) had previously attempted suicide. Of the 657 participants, 461 (70.2%) were assessed at 12 months. Primary outcomes were nonsignificant. There was no significant effect on likelihood or severity of current suicidal ideation or likelihood of a suicide risk incident; there was also no effect on emergency department visits. However, participants who received Caring Contacts (172 of 216 participants [79.6%]) had lower odds than those receiving standard care alone (179 of 204 participants [87.7%]) of experiencing any suicidal ideation between baseline and follow-up (odds ratio, 0.56 [95% CI, 0.33-0.95]; P = .03) and fewer had attempted suicide since baseline (21 of 233 [9.0%] in the group receiving Caring Contacts vs 34 of 228 [14.9%] in the standard-care group; odds ratio, 0.52 [95% CI, 0.29-0.92]; P = .03).
Conclusions and Relevance
This trial provides inconsistent results on the effectiveness of caring text messages between primary and secondary outcomes, but this inexpensive and scalable intervention offers promise for preventing suicide attempts and ideation in military personnel. Additional research is needed.
Trial Registration
ClinicalTrials.gov identifier: NCT01829620.",2019,There was no significant effect on likelihood or severity of current suicidal ideation or likelihood of a suicide risk incident; there was also no effect on emergency department visits.,"['657 individuals (mean [SD] age, 25.2 [6.1] years', '658 randomized participants (329 randomizely assigned to each group', 'Suicide Prevention', 'Military Personnel', '539 men [82.0', '657 participants, 461 (70.2%) were assessed at 12 months', '3 military installations in the southern and western United States']",[],"['worst-point suicidal ideation, emergency department visits, and suicide attempts', 'likelihood or severity of current suicidal ideation', 'Suicidal ideation', 'attempted suicide since baseline', 'current suicidal ideation and suicide risk incidents (hospitalization or medical evacuation', 'suicidal thoughts and behaviors', 'Scale for Suicide Ideation, suicide risk incidents, and emergency department visits', 'suicidal ideation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention (procedure)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0222045'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}]",658.0,0.195533,There was no significant effect on likelihood or severity of current suicidal ideation or likelihood of a suicide risk incident; there was also no effect on emergency department visits.,"[{'ForeName': 'Katherine Anne', 'Initials': 'KA', 'LastName': 'Comtois', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Kerbrat', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'DeCou', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Atkins', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Justine J', 'Initials': 'JJ', 'LastName': 'Majeres', 'Affiliation': 'Womack Army Medical Center, Fort Bragg, North Carolina.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Baker', 'Affiliation': 'Naval Medical Center Camp Lejeune, Camp Lejeune, North Carolina.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Ries', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, School of Medicine, University of Washington, Seattle.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2018.4530']
770,30807545,Cardiac Arrest Outcomes in Children With Preexisting Neurobehavioral Impairment.,"OBJECTIVES
To describe survival and 3-month and 12-month neurobehavioral outcomes in children with preexisting neurobehavioral impairment enrolled in one of two parallel randomized clinical trials of targeted temperature management.
DESIGN
Secondary analysis of Therapeutic Hypothermia after Pediatric Cardiac Arrest In-Hospital and Out-of-Hospital trials data.
SETTING
Forty-one PICUs in the United States, Canada, and United Kingdom.
PATIENTS
Eighty-four participants (59 in-hospital cardiac arrest and 25 out-of-hospital cardiac arrest), 49 males, 35 females, mean age 4.6 years (SD, 5.36 yr), with precardiac arrest neurobehavioral impairment (Vineland Adaptive Behavior Scales, Second Edition composite score < 70). All required chest compressions for greater than or equal to 2 minutes, were comatose and required mechanical ventilation after return of circulation.
INTERVENTIONS
Neurobehavioral function was assessed using the Vineland Adaptive Behavior Scales, Second Edition at baseline (reflecting precardiac arrest status), and at 3 and 12 months postcardiac arrest, followed by on-site cognitive evaluation. Vineland Adaptive Behavior Scales, Second Edition norms are 100 (mean) ± 15 (SD); higher scores indicate better function. Analyses evaluated survival, changes in Vineland Adaptive Behavior Scales, Second Edition, and cognitive functioning.
MEASUREMENTS AND MAIN RESULTS
Twenty-eight of 84 (33%) survived to 12 months (in-hospital cardiac arrest, 19/59 (32%); out-of-hospital cardiac arrest, 9/25 [36%]). In-hospital cardiac arrest (but not out-of-hospital cardiac arrest) survival rate was significantly lower compared with the Therapeutic Hypothermia after Pediatric Cardiac Arrest group without precardiac arrest neurobehavioral impairment. Twenty-five survived with decrease in Vineland Adaptive Behavior Scales, Second Edition less than or equal to 15 (in-hospital cardiac arrest, 18/59 (31%); out-of-hospital cardiac arrest, 7/25 [28%]). At 3-months postcardiac arrest, mean Vineland Adaptive Behavior Scales, Second Edition scores declined significantly (-5; SD, 14; p < 0.05). At 12 months, Vineland Adaptive Behavior Scales, Second Edition declined after out-of-hospital cardiac arrest (-10; SD, 12; p < 0.05), but not in-hospital cardiac arrest (0; SD, 15); 43% (12/28) had unchanged or improved scores.
CONCLUSIONS
This study demonstrates the feasibility, utility, and challenge of including this population in clinical neuroprotection trials. In children with preexisting neurobehavioral impairment, one-third survived to 12 months and their neurobehavioral outcomes varied broadly.",2019,survival rate was significantly lower compared with the Therapeutic Hypothermia after Pediatric Cardiac Arrest group without precardiac arrest neurobehavioral impairment.,"['Forty-one PICUs in the United States, Canada, and United Kingdom', 'children with preexisting neurobehavioral impairment enrolled in one of two parallel randomized clinical trials of targeted temperature management', 'Eighty-four participants (59 in-hospital cardiac arrest and 25 out-of-hospital cardiac arrest), 49 males, 35 females, mean age 4.6 years (SD, 5.36 yr), with precardiac arrest neurobehavioral impairment', 'Children With Preexisting Neurobehavioral Impairment']",[],"['survival rate', 'mean Vineland Adaptive Behavior Scales, Second Edition scores', 'hospital cardiac arrest', 'Vineland Adaptive Behavior Scales', 'survival, changes in Vineland Adaptive Behavior Scales, Second Edition, and cognitive functioning', 'Vineland Adaptive Behavior Scales, Second Edition declined after out-of-hospital cardiac arrest']","[{'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}]",,0.0285492,survival rate was significantly lower compared with the Therapeutic Hypothermia after Pediatric Cardiac Arrest group without precardiac arrest neurobehavioral impairment.,"[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Christensen', 'Affiliation': 'Department of Pediatric Rehabilitation Medicine, Kennedy Krieger Institute, Baltimore, MD.'}, {'ForeName': 'Beth S', 'Initials': 'BS', 'LastName': 'Slomine', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Faye S', 'Initials': 'FS', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Moler', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, MI.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001897']
771,31164360,"Barriers and facilitators of loaded self-managed exercises and physical activity in people with patellofemoral pain: understanding the feasibility of delivering a multicentred randomised controlled trial, a UK qualitative study.","OBJECTIVES
There is an emergent body of evidence supporting exercise therapy and physical activity in the management of musculoskeletal pain. The purpose of this study was to explore potential barriers and facilitators with patients and physiotherapists with patellofemoral pain involved in a feasibility randomised controlled trial (RCT) study. The trial investigated a loaded self-managed exercise intervention, which included education and advice on physical activity versus usual physiotherapy as the control.
DESIGN
Qualitative study, embedded within a mixed-methods design, using semi-structured interviews.
SETTING
A UK National Health Service physiotherapy clinic in a large teaching hospital.
PARTICIPANTS
Purposively sampled 20 participants within a feasibility RCT study; 10 patients with a diagnosis of patellofemoral pain, aged between 18 and 40 years, and 10 physiotherapists delivering the interventions.
RESULTS
In respect to barriers and facilitators, the five overlapping themes that emerged from the data were: (1) locus of control; (2) belief and attitude to pain; (3) treatment expectations and preference; (4) participants' engagement with the loaded self-managed exercises and (5) physiotherapists' clinical development. Locus of control was one overarching theme that was evident throughout. Contrary to popular concerns relating to painful exercises, all participants in the intervention group reported positive engagement. Both physiotherapists and patients, in the intervention group, viewed the single exercise approach in a positive manner. Participants within the intervention group described narratives demonstrating self-efficacy, with greater internal locus of control compared with those who received usual physiotherapy, particularly in relation to physical activity.
CONCLUSIONS
Implementation, delivery and evaluation of the intervention in clinical settings may be challenging, but feasible with the appropriate training for physiotherapists. Participants' improvements in pain and function may have been mediated, in some part, by greater self-efficacy and locus of control.
TRIAL REGISTRATION NUMBER
ISRCTN35272486; Pre-results.",2019,"Participants within the intervention group described narratives demonstrating self-efficacy, with greater internal locus of control compared with those who received usual physiotherapy, particularly in relation to physical activity.
","['patients and physiotherapists with patellofemoral pain', 'Purposively sampled 20 participants within a feasibility RCT study; 10 patients with a diagnosis of patellofemoral pain, aged between 18 and 40 years, and 10 physiotherapists delivering the interventions', 'A UK National Health Service physiotherapy clinic in a large teaching hospital', 'people with patellofemoral pain']","['loaded self-managed exercises and physical activity', 'loaded self-managed exercise intervention, which included education and advice on physical activity versus usual physiotherapy as the control', 'usual physiotherapy']","['positive engagement', 'pain and function', 'narratives demonstrating self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",10.0,0.110868,"Participants within the intervention group described narratives demonstrating self-efficacy, with greater internal locus of control compared with those who received usual physiotherapy, particularly in relation to physical activity.
","[{'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Smith', 'Affiliation': 'University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Moffatt', 'Affiliation': 'Division of Physiotherapy and Rehabilitation Sciences, School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hendrick', 'Affiliation': 'Division of Physiotherapy and Rehabilitation Sciences, School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bateman', 'Affiliation': 'University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Selfe', 'Affiliation': 'Department of Health Professions, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Michael Skovdal', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Research Unit for General Practice in Aalborg, Department of Clinical Medicine at Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Toby O', 'Initials': 'TO', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Logan', 'Affiliation': 'Division of Rehabilitation and Ageing, School of Medicine, University of Nottingham, Nottingham, UK.'}]",BMJ open,['10.1136/bmjopen-2018-023805']
772,30308287,Daily factors driving daily substance use and chronic pain among older adults with HIV: An exploratory study using ecological momentary assessment.,"BACKGROUND
Adults 50 and older make up approximately 50% of persons living with HIV. Multiple co-morbidities are common among this group, including chronic pain and substance abuse, yet little is known about the daily factors that either enhance or inhibit these experiences or behaviors. This study explored daily drivers of substance use, pain, and relief from pain among older adults living with HIV utilizing ecological momentary assessment (EMA).
METHOD
Participants (N = 55), ages 49-71, completed seven consecutive days of daily EMA online surveys prior to treatment initiation within a randomized controlled trial. Multilevel modeling tested predictors of pain, substance use, and relief from pain by examining within- and between-person relationships.
RESULTS
Results revealed an associational, reciprocal relationship between daily worst pain and daily drinking, where greater worst pain ratings predicted heavier drinking and heavier drinking predicted greater daily and overall pain. Greater happiness and poorer quality of sleep predicted greater daily worst pain. Exercising and overall confidence to cope with pain without medication were associated with lower levels of daily worst pain. Finally, spending less time with a loved one over time and reporting any coping behavior were associated with relief from pain.
CONCLUSION
Investigation of daily factors that drive pain and substance use behaviors among this unique population help inform which daily factors are most risky to their health and well-being. Alcohol use emerged as the only substance associated with both driving pain and responding to pain. Findings suggest key points for prevention and intervention.",2019,"Finally, spending less time with a loved one over time and reporting any coping behavior were associated with relief from pain.
","['Participants (N\xa0=\xa055), ages 49-71, completed seven consecutive days of daily EMA online surveys prior to treatment initiation within a randomized controlled trial', 'Adults 50 and older make up approximately 50% of persons living with HIV', 'older adults living with HIV utilizing ecological momentary assessment (EMA', 'older adults with HIV']",[],"['daily and overall pain', 'Greater happiness and poorer quality of sleep', 'driving pain and responding to pain', 'pain, substance use, and relief from pain', 'levels of daily worst pain', 'associational, reciprocal relationship between daily worst pain and daily drinking']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0268596', 'cui_str': 'Glutaric Acidemia, Type 2'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C4083063', 'cui_str': 'Responds to pain'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",,0.121841,"Finally, spending less time with a loved one over time and reporting any coping behavior were associated with relief from pain.
","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Kuerbis', 'Affiliation': 'Silberman School of Social Work, Hunter College at City University of New York, 2180 Third Avenue, New York 10035, United States. Electronic address: ak1465@hunter.cuny.edu.'}, {'ForeName': 'M Carrington', 'Initials': 'MC', 'LastName': 'Reid', 'Affiliation': 'Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, United States.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Lake', 'Affiliation': 'Division of Infectious Diseases, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Glasner-Edwards', 'Affiliation': 'Integrated Substance Abuse Programs, Department of Psychiatry and Biobehavioral Sciences, School of Nursing, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Jenkins', 'Affiliation': 'Department of Psychiatry and Human Behavior, Charles R. Drew University of Medicine and Science, Los Angeles, CA, United States; Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Liao', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Jury', 'Initials': 'J', 'LastName': 'Candelario', 'Affiliation': 'APAIT, A Division of Special Services for Groups, Los Angeles, CA, United States.'}, {'ForeName': 'Alison A', 'Initials': 'AA', 'LastName': 'Moore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, Los Angeles, CA, United States.'}]","Alcohol (Fayetteville, N.Y.)",['10.1016/j.alcohol.2018.10.003']
773,32039559,"Challenges of calcineurin inhibitor withdrawal following combined pancreas and kidney transplantation: Results of a prospective, randomized clinical trial.","In a phase 2 multicenter open-label randomized trial sponsored by the National Institutes of Health, simultaneous pancreas-kidney (SPK) recipients were randomized to a calcineurin inhibitor (CNI)-based immunosuppressive regimen (tacrolimus) (n = 21), or an investigational arm using low-dose CNI plus costimulation blockade (belatacept) with intended CNI withdrawal (n = 22). Both arms included induction therapy with rabbit ATG, mycophenolate sodium, or mycophenolate mofetil and rapid withdrawal of steroids. Enrollment and CNI withdrawal were stopped after 43/60 planned subjects had been enrolled. At that time, the rate of biopsy-proven acute rejection (BPAR) of the pancreas was low in both groups until CNI was withdrawn, with four of the five pancreas rejections occurring during or after CNI withdrawal. The rate of BPAR of kidney allografts was low in both control (9.5%) and investigational (9.1%) arms. Pancreas graft survival at 52 weeks, defined by insulin independence, was 21 (100%) in the control group and 19 (86%) in the investigational arm. One subject in the investigational arm died with functioning pancreas and kidney grafts. Renal function at week 52 was similar in both arms. Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.",2020,Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.,"['43/60 planned subjects had been enrolled', 'SPK transplants undergoing CNI withdrawal', 'combined pancreas and kidney transplantation', 'National Institutes of Health, simultaneous pancreas-kidney (SPK) recipients']","['rabbit ATG, mycophenolate sodium or mycophenolate mofetil', 'calcineurin inhibitor (CNI) based immunosuppressive regimen (tacrolimus) (n=21) or an investigational arm using low-dose CNI plus co-stimulation blockade (belatacept) with intended CNI withdrawal', 'belatacept', 'calcineurin inhibitor withdrawal']","['Pancreas graft survival', 'Renal function', 'rate of biopsy proven acute rejection (BPAR) of the pancreas', 'rate of BPAR of kidney allografts']","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C1337395', 'cui_str': 'mycophenolate sodium'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}]","[{'cui': 'C0030275', 'cui_str': 'Grafting, Pancreas'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}]",,0.0714917,Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.,"[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Stock', 'Affiliation': 'UCSF, San Francisco, California, USA.'}, {'ForeName': 'Roslyn B', 'Initials': 'RB', 'LastName': 'Mannon', 'Affiliation': 'UAB, Birmingham, Alabama, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Rho Inc., Durham, North Carolina, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Watson', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ikle', 'Affiliation': 'Rho Inc., Durham, North Carolina, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Robien', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Morrison', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Odorico', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fridell', 'Affiliation': 'IU, Indianapolis, Indiana, USA.'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Newell', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15817']
774,32022827,Safety and Efficacy of Exposure-Based Risk Reduction Through Family Therapy for Co-occurring Substance Use Problems and Posttraumatic Stress Disorder Symptoms Among Adolescents: A Randomized Clinical Trial.,"Importance
No empirically supported treatments have been evaluated to address co-occurring substance use problems (SUP) and posttraumatic stress disorder (PTSD) symptoms among adolescents in an integrative fashion. This lack is partially owing to untested clinical lore suggesting that delivery of exposure-based PTSD treatments to youth with SUP might be iatrogenic.
Objective
To determine whether an exposure-based, integrative intervention for adolescents with SUP and PTSD symptoms-risk reduction through family therapy (RRFT)-resulted in improved outcomes relative to a treatment-as-usual (TAU) control condition consisting primarily of trauma-focused cognitive behavioral therapy.
Design, Setting, and Participants
This randomized clinical trial enrolled 124 participants who were recruited from November 1, 2012, through January 30, 2017. Adolescents (aged 13-18 years) who engaged in nontobacco substance use at least once during the past 90 days, experienced at least 1 interpersonal traumatic event, and reported 5 or more PTSD symptoms were enrolled. Blinded assessments were collected at baseline and at 3, 6, 12, and 18 months after baseline. Recruitment and treatment took place in community-based child advocacy centers in the Southeastern United States. Data were analyzed from August 2 through October 4, 2018, and were based on intention to treat.
Interventions
Participants were randomized to receive RRFT (n = 61) or TAU (n = 63).
Main Outcomes and Measures
Primary outcomes focused on number of nontobacco substance-using days measured with the timeline follow-back method and PTSD symptom severity using the UCLA (University of California, Los Angeles) PTSD Reaction Index for DSM-IV completed by adolescents and caregivers. Secondary outcomes focused on marijuana, alcohol, and polysubstance use and PTSD criterion standard (re-experiencing, avoidance, and hyperarousal) symptom severity.
Results
In all, 124 adolescents (mean [SD] age, 15.4 [1.3] years; 108 female [87.1%]) were randomized. For primary outcomes relative to TAU, RRFT yielded significantly greater reductions in substance-using days from baseline to month 12 (event rate [ER], 0.28; 95% CI, 0.12-0.65) and month 18 (ER, 0.10; 95% CI, 0.04-0.24). Significant reductions in PTSD symptoms were observed within groups for RRFT from baseline to months 3 (β = -9.25; 95% CI, -12.95 to -5.55), 6 (β = -16.63; 95% CI = -20.40 to -12.87), 12 (β = -17.51; 95% CI, -21.62 to -13.40), and 18 (β = -19.02; 95% CI, -23.07 to -14.96) and for TAU from baseline to months 3 (β = -9.62; 95% CI, -13.16 to -6.08), 6 (β = -13.73; 95% CI, -17.43 to -10.03), 12 (β = -15.53; 95% CI, -19.52 to -11.55), and 18 (β = -13.88; 95% CI, -17.69 to -10.09); however, between-group differences were not observed.
Conclusions and Relevance
In this study, RRFT and TAU demonstrated within-group improvements in SUP and PTSD symptoms, with greater improvement for substance use and PTSD avoidance and hyperarousal symptoms among adolescents randomized to RRFT compared with TAU. No evidence of the worsening of SUP was observed in either condition. These results suggest that this exposure-based treatment is safe, feasibly delivered by community-based clinicians, and offers an effective approach to inform clinical practice.
Trial Registration
ClinicalTrials.gov Identifier: NCT01751035.",2020,"For primary outcomes relative to TAU, RRFT yielded significantly greater reductions in substance-using days from baseline to month 12 (event rate [ER], 0.28; 95% CI, 0.12-0.65) and month 18 (ER, 0.10; 95% CI, 0.04-0.24).","['124 adolescents (mean [SD] age, 15.4 [1.3] years; 108 female [87.1%]) were randomized', 'community-based child advocacy centers in the Southeastern United States', 'Adolescents (aged 13-18 years) who engaged in nontobacco substance use at least once during the past 90 days, experienced at least 1 interpersonal traumatic event, and reported 5 or more PTSD symptoms were enrolled', 'adolescents with SUP and PTSD symptoms-risk reduction through family', 'Adolescents', '124 participants who were recruited from November 1, 2012, through January 30, 2017']","['treatment-as-usual (TAU) control condition consisting primarily of trauma-focused cognitive behavioral therapy', 'therapy (RRFT)-resulted', 'exposure-based, integrative intervention', 'Exposure-Based Risk Reduction Through Family Therapy', 'TAU', 'RRFT']","['SUP and PTSD symptoms', 'marijuana, alcohol, and polysubstance use and PTSD criterion standard (re-experiencing, avoidance, and hyperarousal) symptom severity', 'worsening of SUP', 'number of nontobacco substance-using days measured with the timeline follow-back method and PTSD symptom severity using the UCLA (University of California, Los Angeles) PTSD Reaction Index for DSM-IV completed by adolescents and caregivers', 'PTSD symptoms', 'substance use and PTSD avoidance and hyperarousal symptoms']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008063', 'cui_str': 'Child Advocacy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",124.0,0.169046,"For primary outcomes relative to TAU, RRFT yielded significantly greater reductions in substance-using days from baseline to month 12 (event rate [ER], 0.28; 95% CI, 0.12-0.65) and month 18 (ER, 0.10; 95% CI, 0.04-0.24).","[{'ForeName': 'Carla Kmett', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, National Crime Victims Research & Treatment Center, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Adams', 'Affiliation': 'Adolescent Behavioral Health Research Program, Department of Psychiatry, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, Eugene.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, National Crime Victims Research & Treatment Center, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Smalling', 'Affiliation': 'Dee Norton Child Advocacy Center, Charleston, South Carolina.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'de Arellano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, National Crime Victims Research & Treatment Center, Medical University of South Carolina, Charleston.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4803']
775,31259767,HIV stigma and viral load among African-American women receiving treatment for HIV.,"OBJECTIVE
African-American women are more likely than other women in the United States to experience poor HIV-related health; HIV stigma may contribute to these outcomes. This study assessed the relationship between HIV stigma and viral load, over time, among a sample of African-American women receiving treatment for HIV, and explored social support and depressive symptoms as mediators.
DESIGN
Secondary analysis of longitudinal data.
METHODS
Data came from a randomized trial of an intervention to reduce HIV stigma among African-American women in HIV care in Chicago, Illinois and Birmingham, Alabama. Sociodemographic and psychosocial data were collected at up to six study visits over 14 months. Viral loads were extracted from medical records during the study period. Generalized linear mixed effects models were used to estimate associations among overall, internalized, and enacted HIV stigma and viral load over time. Mediation analyses were used to estimate indirect effects via social support and depressive symptoms.
RESULTS
Data from 234 women were analyzed. Overall HIV stigma was significantly associated with subsequent viral load (adjusted β = 0.24, P = 0.005). Both between-subject (adjusted β = 0.74, P < 0.001) and within-subject (adjusted β = 0.34, P = 0.005) differences in enacted stigma were associated with viral load. Neither social support nor depressive symptoms were statistically significant mediators.
CONCLUSION
Ongoing experiences of HIV stigmatization may contribute to increased viral load among African-American women in primary HIV care. Interventions should aim to alleviate the consequences of stigma experienced by patients and prevent future stigmatization.",2019,"Overall HIV stigma was significantly associated with subsequent viral load (adjusted β = 0.24, P = 0.005).","['African-American women in HIV care in Chicago, Illinois and Birmingham, Alabama', 'African-American women', 'African-American women in primary HIV care', '234 women were analyzed', 'African-American women receiving treatment for HIV', 'African-American women receiving treatment for HIV, and explored social support and depressive symptoms as mediators']",[],"['Overall HIV stigma', 'enacted stigma', 'Sociodemographic and psychosocial data', 'depressive symptoms', 'HIV stigma', 'overall, internalized, and enacted HIV stigma and viral load over time', 'Viral loads', 'HIV stigma and viral load']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037438'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",234.0,0.0469557,"Overall HIV stigma was significantly associated with subsequent viral load (adjusted β = 0.24, P = 0.005).","[{'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Kemp', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lipira', 'Affiliation': 'Department of Health Services.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'School of Social Work.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Nevin', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Simoni', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Cohn', 'Affiliation': 'Division of Infectious Diseases, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Mieoak', 'Initials': 'M', 'LastName': 'Bahk', 'Affiliation': 'Ruth M. Rothstein CORE Center, Chicago, Illinois.'}, {'ForeName': 'Baiba', 'Initials': 'B', 'LastName': 'Berzins', 'Affiliation': 'Division of Infectious Diseases, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Andrasik', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Rao', 'Affiliation': 'Department of Global Health.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002212']
776,30536713,Comparison of BMD Changes and Bone Formation Marker Levels 3 Years After Bisphosphonate Discontinuation: FLEX and HORIZON-PFT Extension I Trials.,"An ASBMR Task Force recommends a drug holiday for certain women treated for ≥5 years with oral alendronate or ≥3 years with intravenous zoledronic acid, with reassessment 2 to 3 years later. It is not known whether changes in bone mineral density (BMD) or bone turnover markers differ after oral or intravenous therapy. Our goal was to compare changes in BMD and procollagen type I N propeptide (PINP) after oral or intravenous bisphosphonate use. In the Fracture Intervention Trial Long-term Extension (FLEX), women who received a mean 5 years of alendronate were randomized to placebo or continued treatment. In the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly-Pivotal Fracture Trial Extension I (HORIZON-PFT E1), women who received 3 years of zoledronic acid were randomized to placebo or continued treatment. We examined the proportion of participants with BMD loss or PINP gain ≥ least significant change (LSC) and those whose values exceeded a threshold (T-score ≤-2.5 or PINP ≥36.0 ng/mL, a premenopausal median value). After 3 years of placebo, the FLEX group had greater mean total hip BMD decreases (-2.3% versus -1.2% in the HORIZON-PFT E1 group, p < 0.01) and greater rises in PINP (+11.6 ng/mL versus +6.7 ng/mL, p < 0.01). There was a greater proportion of individuals in FLEX with total hip BMD loss and PINP increases that exceeded LSC, and PINP values ≥36.0 ng/mL. In contrast, there were small changes in the proportion of women with femoral neck T-scores ≤-2.5 in both groups. In conclusion, 3 years after bisphosphonate discontinuation, a considerable proportion of former alendronate and zoledronic acid users had meaningful declines in total hip BMD and elevations in PINP. Despite a longer treatment course, alendronate may have a more rapid offset of drug effect than zoledronic acid. © 2018 American Society for Bone and Mineral Research.",2019,It is not known whether changes in bone mineral density (BMD) or bone turnover markers differ after oral or intravenous therapy.,"['3 Years', 'women who received a mean 5 years of', '© 2018 American Society for Bone and Mineral Research', 'women who received 3 years of', 'certain women treated for ≥5 years with oral alendronate or ≥3 years with intravenous', 'participants with BMD loss or PINP gain\u2009≥\u2009least significant change (LSC) and those whose values exceeded a threshold (T-score ≤-2.5 or PINP ≥36.0\u2009ng/mL, a premenopausal median value']","['FLEX', 'term Extension (FLEX', 'placebo', 'Bisphosphonate Discontinuation: FLEX and HORIZON-PFT Extension', 'zoledronic acid', 'Zoledronic Acid', 'alendronate', 'bisphosphonate']","['BMD Changes and Bone Formation Marker Levels', 'total hip BMD and elevations in PINP', 'mean total hip BMD decreases', 'BMD and procollagen type', 'rises in PINP', 'bone mineral density (BMD) or bone turnover markers']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}]",,0.129345,It is not known whether changes in bone mineral density (BMD) or bone turnover markers differ after oral or intravenous therapy.,"[{'ForeName': 'Tiffany Y', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'McNabb', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Schafer', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Clinical Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Black', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3654']
777,31521683,The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation.,"OBJECTIVES
This study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling.
BACKGROUND
Functional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis.
METHODS
In this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham. The pre-specified primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis.
RESULTS
Patients (69.8 ± 9.5 years of age) were randomized to either the treatment (n = 87) or the sham-controlled (n = 33) arm. There were no significant differences in baseline characteristics between the groups. In the treatment group, 73 of 87 (84%) had the device implanted. The primary endpoint was met, with a statistically significant reduction in mitral regurgitant volume in the treatment group compared to the control group (decrease of 7.1 ml/beat [95% confidence interval [CI]: -11.7 to -2.5] vs. an increase of 3.3 ml/beat [95% CI: -6.0 to 12.6], respectively; p = 0.049). Additionally, there was a significant reduction in left ventricular volumes in patients receiving the device versus those in the control group (left ventricular end-diastolic volume decrease of 10.4 ml [95% CI: -18.5 to -2.4] vs. an increase of 6.5 ml [95% CI: -5.1 to 18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2 ml [95% CI: -12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: -1.42 to 13.6]; p = 0.04).
CONCLUSIONS
The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy. (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830).",2019,The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy.,"['symptomatic patients with functional mitral regurgitation receiving optimal medical therapy', '120 patients receiving optimal heart failure medical therapy', 'Patients (69.8 ± 9.5 years of age', 'Annuloplasty in Functional Mitral Regurgitation']","['coronary sinus-based mitral annular reduction approach for FMR or sham', 'Carillon device', 'Percutaneous Mitral']","['mitral regurgitant volume and left ventricular volumes', 'mitral regurgitant volume', 'left ventricular volumes']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation (disorder)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0190165', 'cui_str': 'Reconstruction of annulus of cardiac valve (procedure)'}]","[{'cui': 'C0456944', 'cui_str': 'Coronary Sinus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]",120.0,0.176771,The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy.,"[{'ForeName': 'Klaus K', 'Initials': 'KK', 'LastName': 'Witte', 'Affiliation': 'Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom. Electronic address: k.k.witte@leeds.ac.uk.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Lipiecki', 'Affiliation': 'Clinique Pôle Sanioyté République, Clermont Ferrand, France.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Siminiak', 'Affiliation': 'Poznan University of Medical Sciences, HCP Medical Center, Poznan, Poland.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Meredith', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Malkin', 'Affiliation': 'Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Goldberg', 'Affiliation': 'Tyler Heart Institute at Community Hospital of the Monterey Peninsula, Monterey, California; Cardiac Dimensions, Kirkland, Washington.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Stark', 'Affiliation': 'Cardiac Dimensions, Kirkland, Washington.'}, {'ForeName': 'Ralph Stephan', 'Initials': 'RS', 'LastName': 'von Bardeleben', 'Affiliation': 'Department of Cardiology, University Medical Centre Mainz, Mainz, Germany.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Cremer', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Wael A', 'Initials': 'WA', 'LastName': 'Jaber', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Celermajer', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kaye', 'Affiliation': 'Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Sievert', 'Affiliation': 'CardioVascular Center Sankt Katherinen, Frankfurt, Germany; Anglia Ruskin University, Chelmsford, United Kingdom.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.06.011']
778,31319102,Effect of sleep deprivation and exercise on reaction threshold in adults with peanut allergy: A randomized controlled study.,"BACKGROUND
Peanut allergy causes severe and fatal reactions. Current food allergen labeling does not address these risks adequately against the burden of restricting food choice for allergic patients because of limited data on thresholds of reactivity and the influence of everyday factors.
OBJECTIVE
We estimated peanut threshold doses for a United Kingdom population with peanut allergy and examined the effect of sleep deprivation and exercise.
METHODS
In a crossover study, after blind challenge, participants with peanut allergy underwent 3 open peanut challenges in random order: with exercise after each dose, with sleep deprivation preceding challenge, and with no intervention. Primary outcome was the threshold dose triggering symptoms (in milligrams of protein). Primary analysis estimated the difference between the nonintervention challenge and each intervention in log threshold (as percentage change). Dose distributions were modeled, deriving eliciting doses in the population with peanut allergy.
RESULTS
Baseline challenges were performed in 126 participants, 100 were randomized, and 81 (mean age, 25 years) completed at least 1 further challenge. The mean threshold was 214 mg (SD, 330 mg) for nonintervention challenges, and this was reduced by 45% (95% CI, 21% to 61%; P = .001) and 45% (95% CI, 22% to 62%; P = .001) for exercise and sleep deprivation, respectively. Mean estimated eliciting doses for 1% of the population were 1.5 mg (95% CI, 0.8-2.5 mg) during nonintervention challenge (n = 81), 0.5 mg (95% CI, 0.2-0.8 mg) after sleep, and 0.3 mg (95% CI, 0.1-0.6 mg) after exercise.
CONCLUSION
Exercise and sleep deprivation each significantly reduce the threshold of reactivity in patients with peanut allergy, putting them at greater risk of a reaction. Adjusting reference doses using these data will improve allergen risk management and labeling to optimize protection of consumers with peanut allergy.",2019,Adjusting reference doses using these data will improve allergen risk-management and labelling to optimize protection of peanut-allergic consumers.,"['peanut-allergic adults', '126 subjects, 100 were randomized and 81 (mean age 25y) completed at least one further challenge', 'peanut-allergic participants']","['sleep deprivation and exercise', 'Exercise and sleep deprivation']",['threshold dose triggering symptoms (mg protein'],"[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",100.0,0.275034,Adjusting reference doses using these data will improve allergen risk-management and labelling to optimize protection of peanut-allergic consumers.,"[{'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Dua', 'Affiliation': ""Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom. Electronic address: shelley.dua@addenbrookes.nhs.uk.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ruiz-Garcia', 'Affiliation': 'Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': ""Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'Allergy and Clinical Immunology, Section Inflammation Repair and Development National heart and Lung Institute, Faculty of Medicine, Imperial College, London and Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kimber', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Mills', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'NIHR Southampton Respiratory Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; University of Southampton Faculty of Medicine, Southampton, United Kingdom.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Skypala', 'Affiliation': 'National Heart and Lung Institute, Imperial College London and Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'MRC Biostatistics Unit, Cambridge Institute of Public Health, Cambridge, United Kingdom; Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ewan', 'Affiliation': ""Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Boyle', 'Affiliation': 'Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom; Centre of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': ""Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.06.038']
779,30969846,"Patient-Reported Outcome Results From the Open-Label, Randomized Phase III Myeloma X Trial Evaluating Salvage Autologous Stem-Cell Transplantation in Relapsed Multiple Myeloma.","PURPOSE
Salvage autologous stem-cell transplantation (sASCT) in patients with multiple myeloma (MM) relapsing after a prior autologous stem-cell transplantation leads to increased remission duration and overall survival. We report a comprehensive study on patient-reported outcomes, including quality of life (QoL) and pain in sASCT.
METHODS
Patients were randomly assigned to either sASCT or nontransplantation consolidation (NTC). Pain and QoL were assessed as secondary outcomes using validated QoL instruments (European Organisation for Research and Treatment of Cancer QLQ-C30 and myeloma-specific module, QLQ-MY20; the Brief Pain Inventory [Short Form]; and the Leeds Assessment of Neuropathic Symptoms and Signs [Self-Assessment] scale).
RESULTS
A total of 288 patients (> 96%) consented to the QoL substudy. The median follow-up was 52 months. The European Organisation for Research and Treatment of Cancer QLQ-C30 Global health status scores were higher (better) in the NTC group at 100 days after random assignment ( P = .0496), but not at later time points. Pain interference was higher (worse) in the sASCT group than in the NTC group at 6 months after random assignment ( P = .0267), with patients with sASCT reporting higher scores for Pain interference with daily living for up to 2 years after random assignment. Patients reporting lower concerns about adverse effects of treatment after sASCT had a time to progression advantage.
CONCLUSION
Patients with sASCT with relapsed MM demonstrated a comparative reduction in QoL and greater impact of treatment adverse effects lasting for 6 months and up to 2 years for pain, after which patients who had received sASCT reported better outcomes. Patients who experienced lower adverse effects after sASCT had longer time to progression and overall survival, showing the need to improve symptom management peritransplantation. To our knowledge, this study provides the most comprehensive picture of QoL before and after sASCT in patients with relapsed MM.",2019,"Pain interference was higher (worse) in the sASCT group than in the NTC group at 6 months after random assignment ( P = .0267), with patients with sASCT reporting higher scores for Pain interference with daily living for up to 2 years after random assignment.","['patients with relapsed MM', 'Patients', 'patients with multiple myeloma (MM) relapsing after a prior autologous stem-cell transplantation', '288 patients (> 96%) consented to the QoL substudy']","['Salvage Autologous Stem-Cell Transplantation', 'Salvage autologous stem-cell transplantation (sASCT', 'NTC', 'sASCT', 'sASCT or nontransplantation consolidation (NTC']","['Pain and QoL', 'validated QoL instruments (European Organisation for Research and Treatment of Cancer QLQ-C30 and myeloma-specific module, QLQ-MY20; the Brief Pain Inventory [Short Form]; and the Leeds Assessment of Neuropathic Symptoms and Signs [Self-Assessment] scale', 'remission duration and overall survival', 'Cancer QLQ-C30 Global health status scores', 'longer time to progression and overall survival', 'quality of life (QoL) and pain in sASCT', 'Pain interference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0222045'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034380'}]",288.0,0.108635,"Pain interference was higher (worse) in the sASCT group than in the NTC group at 6 months after random assignment ( P = .0267), with patients with sASCT reporting higher scores for Pain interference with daily living for up to 2 years after random assignment.","[{'ForeName': 'Sam H', 'Initials': 'SH', 'LastName': 'Ahmedzai', 'Affiliation': '1 The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Snowden', 'Affiliation': '2 Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Andrew John', 'Initials': 'AJ', 'LastName': 'Ashcroft', 'Affiliation': '3 Pinderfields Hospital, Mid-Yorks NHS Trust, Wakefield, United Kingdom.'}, {'ForeName': 'David Allan', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': '5 Nottingham City Hospitals, Nottingham City, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hockaday', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Jamie D', 'Initials': 'JD', 'LastName': 'Cavenagh', 'Affiliation': '6 Barts Health NHS Trust and The London NHS Trust, London, United Kingdom.'}, {'ForeName': 'Debo', 'Initials': 'D', 'LastName': 'Ademokun', 'Affiliation': '7 Ipswich Hospital NHS Trust, Ipswich, United Kingdom.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Tholouli', 'Affiliation': '8 Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Allotey', 'Affiliation': '9 Royal Derby Hospital, Derby, United Kingdom.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Dhanapal', 'Affiliation': '10 Medway Maritime Hospital, Gillingham, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jenner', 'Affiliation': '11 University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': '12 University College Hospital, London, United Kingdom.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Cavet', 'Affiliation': '13 The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Hunter', 'Affiliation': '14 Plymouth Hospitals Trust, Plymouth, United Kingdom.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Bird', 'Affiliation': '15 University Hospitals Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Pratt', 'Affiliation': '16 University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Parrish', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Brown', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Treen C M', 'Initials': 'TCM', 'LastName': 'Morris', 'Affiliation': ""17 Queen's University, Belfast, United Kingdom.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01006']
780,30840040,Effectiveness of Training Therapists to Deliver An Individualized Mental Health Intervention for Children With ASD in Publicly Funded Mental Health Services: A Cluster Randomized Clinical Trial.,"Importance
Publicly funded mental health services play an important role in addressing co-occurring mental health problems in children with autism spectrum disorder (ASD); however, therapists report lacking training to effectively serve this complex population.
Objective
To test the effectiveness of training community therapists in An Individualized Mental Health Intervention for ASD (AIM HI) on challenging behaviors across 18 months among children with ASD and identify moderators and mediators of any intervention effects.
Design, Setting, and Participants
Cluster randomized trial conducted in 29 publicly funded outpatient and school-based mental health programs in southern California from 2012 to 2017. Programs were randomized to receive immediate AIM HI training or provide usual care followed by receipt of AIM HI training. Therapist participants were recruited from enrolled programs, and child participants were recruited from participant therapists' caseloads. Data were analyzed from 202 children with ASD who were aged 5 to 13 years.
Interventions
The AIM HI protocol is a package of parent-mediated and child-focused strategies aimed to reduce challenging behaviors in children with ASD who are 5 to 13 years old. It was designed for delivery in publicly funded mental health services based on a systematic assessment of therapist training needs and child clinical needs. The therapist training and consultation process takes approximately 6 months and includes an introductory workshop, 11 structured consultation meetings as the therapist delivers AIM HI with a current client, and case-specific performance feedback from trainers.
Main Outcomes and Measures
Child participants were assessed for challenging behaviors using the Eyberg Child Behavior Inventory (ECBI) and Social Skills Improvement System (SSIS) Competing Problem Behaviors scales based on parent report at baseline and at 6-month intervals for 18 months. Outcomes were analyzed using intent-to-treat models.
Results
In total, 202 children with ASD (mean [SD] age, 9.1 [2.4] years; 170 [84.2%] male; 121 [59.9%] Latinx) were eligible, enrolled, and included in the analyses. Statistically significant group by time interactions for the ECBI Intensity (B = -0.38; P = .02) and ECBI Problem (B = -1.00; P = .005) scales were observed, with significantly larger decreases in ECBI Intensity scores in the AIM HI group (B = -1.36; P < .001) relative to the usual care group (B = -0.98; P < .001) and a significantly larger decrease in ECBI Problem scores in the AIM HI group (B = -1.22; P < .001) relative to the usual care group (B = -0.20; P = .29). Therapist fidelity moderated these intervention effects.
Conclusions and Relevance
The present findings support the effectiveness of training therapists to deliver the AIM HI model to children with ASD receiving publicly funded mental health services.
Trial Registration
ClinicalTrials.gov identifier: NCT02416323.",2019,"Statistically significant group by time interactions for the ECBI Intensity (B = -0.38; P = .02) and ECBI Problem (B = -1.00; P = .005) scales were observed, with significantly larger decreases in ECBI Intensity scores in the AIM HI group (B = -1.36; P < .001) relative to the usual care group (B = -0.98; P < .001) and a significantly larger decrease in ECBI Problem scores in the AIM HI group (B = -1.22; P < .001) relative to the usual care group (B = -0.20; P = .29).","['children with ASD', '202 children with ASD (mean [SD] age, 9.1 [2.4] years; 170 [84.2%] male; 121 [59.9%] Latinx) were eligible, enrolled, and included in the analyses', 'Children With ASD in Publicly Funded Mental Health Services', 'children with autism spectrum disorder (ASD', '29 publicly funded outpatient and school-based mental health programs in southern California from 2012 to 2017', '202 children with ASD who were aged 5 to 13 years', 'children with ASD who are 5 to 13 years old', 'children with ASD receiving publicly funded mental health services', ""Therapist participants were recruited from enrolled programs, and child participants were recruited from participant therapists' caseloads""]","['immediate AIM HI training or provide usual care followed by receipt of AIM HI training', 'training community therapists', 'Training Therapists to Deliver An Individualized Mental Health Intervention']","['ECBI Problem scores', 'ECBI Problem', 'challenging behaviors using the Eyberg Child Behavior Inventory (ECBI) and Social Skills Improvement System (SSIS', 'ECBI Intensity scores', 'ECBI Intensity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",202.0,0.11482,"Statistically significant group by time interactions for the ECBI Intensity (B = -0.38; P = .02) and ECBI Problem (B = -1.00; P = .005) scales were observed, with significantly larger decreases in ECBI Intensity scores in the AIM HI group (B = -1.36; P < .001) relative to the usual care group (B = -0.98; P < .001) and a significantly larger decrease in ECBI Problem scores in the AIM HI group (B = -1.22; P < .001) relative to the usual care group (B = -0.20; P = .29).","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brookman-Frazee', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Roesch', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California.'}, {'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Chlebowski', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Baker-Ericzen', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ganger', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.0011']
781,30725077,Association of the Youth-Nominated Support Team Intervention for Suicidal Adolescents With 11- to 14-Year Mortality Outcomes: Secondary Analysis of a Randomized Clinical Trial.,"Importance
The prevalence of suicide among adolescents is rising, yet little is known about effective interventions. To date, no intervention for suicidal adolescents has been shown to reduce mortality.
Objective
To determine whether the Youth-Nominated Support Team Intervention for Suicidal Adolescents-Version II (YST) is associated with reduced mortality 11 to 14 years after psychiatric hospitalization for suicide risk.
Design, Setting, and Participants
This post hoc secondary analysis of a randomized clinical trial used National Death Index (NDI) data from adolescent psychiatric inpatients from 2 US psychiatric hospitals enrolled in the clinical trial from November 10, 2002, to October 26, 2005. Eligible participants were aged 13 to 17 years and presented with suicidal ideation (frequent or with suicidal plan), a suicide attempt, or both within the past 4 weeks. Participants were randomized to receive treatment as usual (TAU) or YST plus TAU (YST). Evaluators and staff who matched identifying data to NDI records were masked to group. The length of NDI follow-up ranged from 11.2 to 14.1 years. Analyses were conducted between February 12, 2018, and September 18, 2018.
Interventions
The YST is a psychoeducational, social support intervention. Adolescents nominated ""caring adults"" (mean, 3.4 per adolescent from family, school, and community) to serve as support persons for them after hospitalization. These adults attended a psychoeducational session to learn about the youth's problem list and treatment plan, suicide warning signs, communicating with adolescents, and how to be helpful in supporting treatment adherence and positive behavioral choices. The adults received weekly supportive telephone calls from YST staff for 3 months.
Main Outcomes and Measures
Survival 11 to 14 years after index hospitalization, measured by NDI data for deaths (suicide, drug overdose, and other causes of premature death), from January 1, 2002, through December 31, 2016.
Results
National Death Index records were reviewed for all 448 YST study participants (319 [71.2%] identified as female; mean [SD] age, 15.6 [1.3] years; 375 [83.7%] of white race/ethnicity). There were 13 deaths in the TAU group and 2 deaths in the YST group (hazard ratio, 6.62; 95% CI, 1.49-29.35; P < .01). No patients were withdrawn from YST owing to adverse effects.
Conclusions and Relevance
The findings suggest that the YST intervention for suicidal adolescents is associated with reduced mortality. Because this was a secondary analysis, results warrant replication with examination of mechanisms.
Trial Registration
ClinicalTrials.gov identifier: NCT00071617.",2019,"There were 13 deaths in the TAU group and 2 deaths in the YST group (hazard ratio, 6.62; 95% CI, 1.49-29.35; P < .01).","['Eligible participants were aged 13 to 17 years and presented with suicidal ideation (frequent or with suicidal plan), a suicide attempt, or both within the past 4 weeks', 'adolescent psychiatric inpatients from 2 US psychiatric hospitals enrolled in the clinical trial from November 10, 2002, to October 26, 2005', 'Suicidal Adolescents-Version II (YST', 'suicidal adolescents', 'Suicidal Adolescents', 'Results\n\n\nNational Death Index records were reviewed for all 448 YST study participants (319 [71.2%] identified as female; mean [SD] age, 15.6 [1.3] years; 375 [83.7%] of white race/ethnicity', 'Adolescents nominated ""caring adults"" (mean, 3.4 per adolescent from family, school, and community) to serve as support persons for them after hospitalization']","['usual (TAU) or YST plus TAU (YST', 'supportive telephone calls from YST staff', 'YST intervention', 'Youth-Nominated Support Team Intervention', 'YST']","['Measures\n\n\nSurvival 11 to 14 years after index hospitalization, measured by NDI data for deaths (suicide, drug overdose, and other causes of premature death', 'mortality']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0424001', 'cui_str': 'Planning suicide (finding)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric inpatient'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1855073', 'cui_str': 'Death, Premature'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.237827,"There were 13 deaths in the TAU group and 2 deaths in the YST group (hazard ratio, 6.62; 95% CI, 1.49-29.35; P < .01).","[{'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Arango', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Busby', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Czyz', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Cynthia Ewell', 'Initials': 'CE', 'LastName': 'Foster', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Gillespie', 'Affiliation': 'Consulting for Statistics, Computing and Analytics Research at the University of Michigan, Ann Arbor.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA psychiatry,['10.1001/jamapsychiatry.2018.4358']
782,30733169,An integrated neurocognitive and social-cognitive treatment for youth at clinical high risk for psychosis: Cognition for Learning and for Understanding Everyday Social Situations (CLUES).,"BACKGROUND
Cognitive deficits, a core feature contributing to disability in schizophrenia, are present in milder form in individuals at clinical high risk (CHR) for psychosis. This study investigated the feasibility of Cognition for Learning and Understanding Everyday Social Situations (CLUES), an integrated neurocognitive and social cognitive treatment for youth at CHR.
METHOD
This was an open, pilot feasibility trial. Seventeen individuals meeting CHR criteria were assessed prior to and following participation in CLUES for changes in symptoms, social and role functioning, and cognition. Participant attitudes towards CLUES were also examined.
RESULTS
Participants significantly improved in social functioning [t(16) = -4.20, p = .001, d = 1.02], and trended for improvement in reaction time [t(15) = 2.09, p = .054, d = 0.52] from baseline to end of treatment. No other measures significantly changed. No participants transitioned to full psychosis during the treatment and follow up period. Participants reported they generally liked CLUES and found it helpful.
CONCLUSION
While limited by the small sample size and the open label design, our preliminary results indicate that CLUES is feasible and shows promise in improving social functioning. However, further investigation is warranted in order to determine its efficacy. Future directions should include conducting a randomized controlled trial in order to compare the efficacy of CLUES to another intervention.",2019,"RESULTS
Participants significantly improved in social functioning [t(16) = -4.20, p = .001, d = 1.02], and trended for improvement in reaction time [t(15) = 2.09, p = .054, d = 0.52] from baseline to end of treatment.","['youth at CHR', 'youth at clinical high risk for psychosis', 'Seventeen individuals meeting CHR criteria']",['CLUES'],"['full psychosis', 'social functioning']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",[],"[{'cui': 'C0033975', 'cui_str': 'Psychoses'}]",17.0,0.0261051,"RESULTS
Participants significantly improved in social functioning [t(16) = -4.20, p = .001, d = 1.02], and trended for improvement in reaction time [t(15) = 2.09, p = .054, d = 0.52] from baseline to end of treatment.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Friedman-Yakoobian', 'Affiliation': 'Public Psychiatry Division of Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, MA 02115, United States of America. Electronic address: mfriedm3@bidmc.harvard.edu.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Parrish', 'Affiliation': 'Public Psychiatry Division of Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, MA 02115, United States of America.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'University of Alabama Health System, United States of America.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lesser', 'Affiliation': 'Cedars Sinai Medical Center, United States of America.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gnong-Granato', 'Affiliation': 'The Plymouth Center for Behavioral Health, United States of America.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Eack', 'Affiliation': 'University of Pittsburgh School of Social Work and Department of Psychiatry, United States of America.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Keshavan', 'Affiliation': 'Public Psychiatry Division of Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, MA 02115, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2019.01.029']
783,31436162,The Association Between Web-Based or Face-to-Face Lifestyle Interventions on the Perceived Benefits and Barriers to Exercise in Midlife Women: Three-Arm Equivalency Study.,"BACKGROUND
Noncommunicable diseases pose a significant threat to women's health globally, with most diseases being attributed to modifiable risk factors such as physical inactivity. Women perceive a range of benefits and barriers to exercise; however, there is little evidence about the effect of different lifestyle intervention delivery modes on perceptions of exercise.
OBJECTIVE
This study aimed to compare the effect of a multiple health behavior change (MHBC) intervention called the Women's Wellness Program. This intervention was delivered in 3 different modes on perceived exercise benefits, perceived exercise barriers, and actual physical activity and exercise in midlife women.
METHODS
Women aged 45 to 65 years were recruited via the study website. They were assigned in blocks to 3 different treatment groups (A: Web-based independent; B: face-to-face with nurse consultations; and C: Web-based with virtual nurse consultations). All participants received the 12-week intervention that utilizes principles from social-cognitive theory to provide a structured guide to promote healthy lifestyle behaviors with an emphasis on regular exercise and healthy eating. Data were collected using a self-report Web-based questionnaire at baseline (T1) and postintervention (T2) including perceived exercise benefits and barriers and exercise and physical activity. A data analysis examined both within- and between-group changes over time.
RESULTS
Participants in this study (N=225) had a mean age of 50.9 years (SD 5.9) and most were married or living with a partner (83.3%, 185/225). Attrition was 30.2% with 157 participants completing the final questionnaire. Women in all intervention groups reported a significant increase in positive perceptions of exercise (P<.05); a significant increase in exercise and overall physical activity (P<.01) with moderate-to-large effect sizes noted for overall physical activity (d=0.5 to d=0.87). Participants receiving support from registered nurses in the face-to-face and Web-based groups had a greater magnitude of change in benefit perceptions and physical activity than those in the Web-based independent group. There was no significant change in exercise barrier perceptions within or between groups over time.
CONCLUSIONS
The results of this study suggest that the (MHBC) intervention is effective in increasing exercise benefit perceptions, overall physical activity, and exercise in midlife women. Although Web-based programs are cost-effective and flexible and can be delivered remotely, providing a range of options including face-to-face group delivery and personalized electronic health coaching from registered nurses has the potential to enhance participant engagement and motivation.",2019,Women in all intervention groups reported a significant increase in positive perceptions of exercise (P<.05); a significant increase in exercise and overall physical activity (P<.01) with moderate-to-large effect sizes noted for overall physical activity (d=0.5 to d=0.87).,"['midlife women', ""Women's Wellness Program"", 'Midlife Women', 'Women aged 45 to 65 years were recruited via the study website', 'Participants in this study (N=225) had a mean age of 50.9 years (SD 5.9) and most were married or living with a partner (83.3%, 185/225']","['multiple health behavior change (MHBC) intervention', 'MHBC) intervention', 'intervention that utilizes principles from social-cognitive theory to provide a structured guide to promote healthy lifestyle behaviors with an emphasis on regular exercise and healthy eating', '3 different modes on perceived exercise benefits, perceived exercise barriers, and actual physical activity and exercise']","['overall physical activity', 'positive perceptions of exercise', 'exercise and overall physical activity', 'Attrition', 'exercise barrier perceptions', 'benefit perceptions and physical activity', 'exercise benefits and barriers and exercise and physical activity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0555047', 'cui_str': 'Married (finding)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0018687'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",157.0,0.0559089,Women in all intervention groups reported a significant increase in positive perceptions of exercise (P<.05); a significant increase in exercise and overall physical activity (P<.01) with moderate-to-large effect sizes noted for overall physical activity (d=0.5 to d=0.87).,"[{'ForeName': 'Amanda Mary', 'Initials': 'AM', 'LastName': 'McGuire', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Southport, Australia.'}, {'ForeName': 'Charrlotte', 'Initials': 'C', 'LastName': 'Seib', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Southport, Australia.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Porter-Steele', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Southport, Australia.'}, {'ForeName': 'Debra Jane', 'Initials': 'DJ', 'LastName': 'Anderson', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Southport, Australia.'}]",Journal of medical Internet research,['10.2196/10963']
784,30381466,Randomised controlled trial of incentives to improve online survey completion among internet-using men who have sex with men.,"BACKGROUND
HIV prevention research often involves the use of online surveys as data collection instruments. Incomplete responses to these surveys can introduce bias. We aimed to develop and assess innovative methods to incentivise respondents to complete surveys.
METHODS
Adult men who have sex with men (MSM) living in the USA were recruited through banner advertisements on Facebook from 27 April 2015 to 6 May 2015 to participate in an online survey about HIV prevention and risk behaviours. Participants were randomised to one of four conditions: a monetary incentive; a series of altruistic messages highlighting the importance of participating in research; access to a dashboard comparing their responses with statistics from other participants after completion; and no incentive. Kaplan-Meier survival methods and univariate Cox proportional hazard models were used to evaluate survey dropout by incentive group and demographic variables of interest.
RESULTS
There were a total of 1178 participants randomised to the four treatment groups. The rate of survey dropout among participants in the altruistic (HR=0.68, 95% CI 0.49 to 0.93), monetary (HR=0.44, 95% CI 0.32 to 0.61) and dashboard (HR=0.78, 95% CI 0.58 to 1.06) groups was lower than the non-incentivised control group. Regardless of condition, survey dropout was also lower among MSM aged 28-34 (HR=0.67, 95% CI 0.50 to 0.90) compared with those aged 18-22 years old, and MSM who were white (HR=0.78, 95% CI 0.60 to 1.02) compared with non-white participants.
CONCLUSION
Monetary incentives and altruistic messaging can improve survey completion in online behavioural HIV prevention research among MSM.
TRIAL REGISTRATION NUMBER
NCT02139566.",2019,"The rate of survey dropout among participants in the altruistic (HR=0.68, 95% CI 0.49 to 0.93), monetary (HR=0.44, 95% CI 0.32 to 0.61) and dashboard (HR=0.78, 95% CI 0.58 to 1.06) groups was lower than the non-incentivised control group.","['Adult men who have sex with men (MSM) living in the USA were recruited through banner advertisements on Facebook from 27 April 2015 to 6 May 2015 to participate in an online survey about HIV prevention and risk behaviours', '1178 participants randomised to the four treatment groups', 'internet-using men who have sex with men']",['monetary incentive; a series of altruistic messages highlighting the importance of participating in research; access to a dashboard comparing their responses with statistics from other participants after completion; and no incentive'],['rate of survey dropout'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}]",1178.0,0.19664,"The rate of survey dropout among participants in the altruistic (HR=0.68, 95% CI 0.49 to 0.93), monetary (HR=0.44, 95% CI 0.32 to 0.61) and dashboard (HR=0.78, 95% CI 0.58 to 1.06) groups was lower than the non-incentivised control group.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Sanchez', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing and Center for Sexuality and Health Disparities, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Robert Craig', 'Initials': 'RC', 'LastName': 'Sineath', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zlotorzynska', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}]",Journal of epidemiology and community health,['10.1136/jech-2018-211166']
785,32146074,"The Effects of Intraoperative Progressive Muscle Relaxation and Virtual Reality Application on Anxiety, Vital Signs, and Satisfaction: A Randomized Controlled Trial.","PURPOSE
This study aimed to determine the effects of intraoperative progressive muscle relaxation (PMR) and the application of virtual reality (VR) on anxiety, vital signs, and satisfaction levels during a knee arthroscopy operation.
DESIGN
The study was a three-group randomized controlled trial.
METHODS
This study was conducted with 93 patients who consented to participate in the study.
FINDINGS
The State-Trait Anxiety Inventory-S anxiety scale (STAI-S) scores were increased in all the three groups after the surgery. When the preoperative and postoperative STAI-S scores in the group were examined; intragroup STAI-S scores in the PMR and VR groups were statistically significant (P < .05). There was a significant difference between the control group and the PMR and VR groups in mean satisfaction scores (P < .05). The differences between blood pressure and pulse rate were statistically significant in the PMR and VR groups (P < .05).
CONCLUSIONS
Intraoperative PMR and VR can be used as nursing interventions to increase satisfaction and positively affect vital signs in patients who undergo surgery with spinal anesthesia.",2020,"The differences between blood pressure and pulse rate were statistically significant in the PMR and VR groups (P < .05).
","['patients who undergo surgery with spinal anesthesia', '93 patients who consented to participate in the study']","['intraoperative progressive muscle relaxation (PMR', 'virtual reality (VR', 'Intraoperative Progressive Muscle Relaxation and Virtual Reality Application']","['Anxiety, Vital Signs, and Satisfaction', 'anxiety, vital signs, and satisfaction levels', 'mean satisfaction scores', 'preoperative and postoperative STAI-S scores', 'blood pressure and pulse rate', 'State-Trait Anxiety Inventory-S anxiety scale (STAI-S) scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518766'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}]",93.0,0.0197409,"The differences between blood pressure and pulse rate were statistically significant in the PMR and VR groups (P < .05).
","[{'ForeName': 'Gul', 'Initials': 'G', 'LastName': 'Sahin', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Training and Research Hospital, Ankara. Electronic address: sahingl@gmail.com.'}, {'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Basak', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Ankara.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.11.002']
786,31623764,Guiding Therapy by Coronary CT Angiography Improves Outcomes in Patients With Stable Chest Pain.,"BACKGROUND
Within the SCOT-HEART (Scottish COmputed Tomography of the HEART Trial) trial of patients with stable chest pain, the use of coronary computed tomography angiography (CTA) reduced the rate of death from coronary heart disease or nonfatal myocardial infarction (primary endpoint).
OBJECTIVES
This study sought to assess the consistency and mechanisms of the 5-year reduction in this endpoint.
METHODS
In this open-label trial, 4,146 participants were randomized to standard care alone or standard care plus coronary CTA. This study explored the primary endpoint by symptoms, diagnosis, coronary revascularizations, and preventative therapies.
RESULTS
Event reductions were consistent across symptom and risk categories (p = NS for interactions). In patients who were not diagnosed with angina due to coronary heart disease, coronary CTA was associated with a lower primary endpoint incidence rate (0.23; 95% confidence interval [CI]: 0.13 to 0.35 vs. 0.59; 95% CI: 0.42 to 0.80 per 100 patient-years; p < 0.001). In those who had undergone coronary CTA, rates of coronary revascularization were higher in the first year (hazard ratio [HR]: 1.21; 95% CI: 1.01 to 1.46; p = 0.042) but lower beyond 1 year (HR: 0.59; 95% CI: 0.38 to 0.90; p = 0.015). Patients assigned to coronary CTA had higher rates of preventative therapies throughout follow-up (p < 0.001 for all), with rates highest in those with CT-defined coronary artery disease. Modeling studies demonstrated the plausibility of the observed effect size.
CONCLUSIONS
The beneficial effect of coronary CTA on outcomes is consistent across subgroups with plausible underlying mechanisms. Coronary CTA improves coronary heart disease outcomes by enabling better targeting of preventative treatments to those with coronary artery disease. (Scottish COmputed Tomography of the HEART Trial [SCOT-HEART]; NCT01149590).",2019,"Patients assigned to coronary CTA had higher rates of preventative therapies throughout follow-up (p < 0.001 for all), with rates highest in those with CT-defined coronary artery disease.","['Patients', 'patients with stable chest pain', '4,146 participants']","['Coronary CTA', 'coronary computed tomography angiography (CTA', 'coronary CTA', 'Coronary CT Angiography', 'standard care alone or standard care plus coronary CTA']","['symptoms, diagnosis, coronary revascularizations, and preventative therapies', 'rates of coronary revascularization', 'coronary heart disease outcomes', 'rates of preventative therapies']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]",4146.0,0.163119,"Patients assigned to coronary CTA had higher rates of preventative therapies throughout follow-up (p < 0.001 for all), with rates highest in those with CT-defined coronary artery disease.","[{'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Christchurch Heart Institute, University of Otago, Christchurch, New Zealand. Electronic address: philip.adamson@cdhb.health.nz.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Boon', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Daghem', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Moss', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Forbes', 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Timmis', 'Affiliation': 'William Harvey Research Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': ""Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Ahmadi', 'Affiliation': ""Ichan School of Medicine and Mount Sinai Hospital, Mount Sinai Heart, New York, New York; St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Leipsic', 'Affiliation': ""St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jagat', 'Initials': 'J', 'LastName': 'Narula', 'Affiliation': 'Ichan School of Medicine and Mount Sinai Hospital, Mount Sinai Heart, New York, New York.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': ""British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Edinburgh Imaging, Queen's Medical Research Institute University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Roditi', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'McAllister', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.085']
787,32119677,Surgical decision making in the setting of severe traumatic brain injury: A survey of neurosurgeons.,"BACKGROUND
Surgical decision-making in severe traumatic brain injury (TBI) is complex. Neurosurgeons weigh risks and benefits of interventions that have the potential to both maximize the chance of recovery and prolong suffering. Inaccurate prognostication can lead to over- or under-estimation of outcomes and influence treatment recommendations.
OBJECTIVE
To evaluate the impact of evidence-based risk estimates on neurosurgeon treatment recommendations and prognostic beliefs in severe TBI.
METHODS
In a survey-based randomized experiment, a total of 139 neurosurgeons were presented with two hypothetical patient with severe TBI and subdural hematoma; the intervention group received additional evidence-based risk estimates for each patient. The main outcome was neurosurgeon treatment recommendation of non-surgical management. Secondary outcomes included prediction of functional recovery at six months.
RESULTS
In the first patient scenario, 22% of neurosurgeons recommended non-surgical management and provision of evidence-based risk estimates increased the propensity to recommend non-surgical treatment (odds ratio [OR]: 2.81, 95% CI: 1.21-6.98; p = 0.02). Neurosurgeon prognostic beliefs of 6-month functional recovery were variable in both control (median 20%, IQR: 10%-40%) and intervention (30% IQR: 10%-50%) groups and neurosurgeons were less likely to recommend non-surgical management when they believed prognosis was favorable (odds ratio [OR] per percentage point increase in 6-month functional recovery: 0.97, 95% confidence interval [CI]: 0.95-0.99). The results for the second patient scenario were qualitatively similar.
CONCLUSIONS
Our findings show that the provision of evidence-based risk predictions can influence neurosurgeon treatment recommendations and prognostication, but the effect is modest and there remains large variability in neurosurgeon prognostication.",2020,"groups and neurosurgeons were less likely to recommend non-surgical management when they believed prognosis was favorable (odds ratio [OR] per percentage point increase in 6-month functional recovery: 0.97, 95% confidence interval [CI]: 0.95-0.99).","['139 neurosurgeons were presented with two hypothetical patient with severe TBI and subdural hematoma', 'severe traumatic brain injury']",[],"['prediction of functional recovery at six months', 'Neurosurgeon prognostic beliefs of 6-month functional recovery', 'neurosurgeon treatment recommendation of non-surgical management']","[{'cui': 'C0237427', 'cui_str': 'Neurological Surgeons'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0475059', 'cui_str': 'Subdural Hematoma, Traumatic'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0237427', 'cui_str': 'Neurological Surgeons'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",139.0,0.189545,"groups and neurosurgeons were less likely to recommend non-surgical management when they believed prognosis was favorable (odds ratio [OR] per percentage point increase in 6-month functional recovery: 0.97, 95% confidence interval [CI]: 0.95-0.99).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Williamson', 'Affiliation': 'Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Ryser', 'Affiliation': 'Department of Population Health Sciences, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Abdelgadir', 'Affiliation': 'Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Lemmon', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Mary Carol', 'Initials': 'MC', 'LastName': 'Barks', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Rasheedat', 'Initials': 'R', 'LastName': 'Zakare', 'Affiliation': 'Duke School of Medicine, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ubel', 'Affiliation': 'Duke School of Medicine, Duke University, Durham, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0228947']
788,31154425,Clinical determinants of plasma cardiac biomarkers in patients with stable chest pain.,"OBJECTIVE
Troponin and B-type natriuretic peptide (BNP) concentrations are associated with cardiovascular risk in stable patients. Understanding their determinants and identifying modifiable clinical targets may improve outcomes. We aimed to establish clinical and cardiac determinants of these biomarkers.
METHODS
This was a prespecified substudy from the randomised Scottish Computed Tomography of the Heart trial, which enrolled patients 18-75 years with suspected stable angina between 2010 and 2014 (NCT01149590). We included patients from six centres in whom high-sensitivity troponin I and BNP were measured (Singulex Erenna). Patients with troponin >99th centile upper reference limit (10.2 ng/L) or BNP ≥400 ng/L were excluded to avoid inclusion of patients with myocardial injury or heart failure. Multivariable linear regression models were constructed with troponin and BNP as dependent variables.
RESULTS
In total, 885 patients were included; 881 (99%) and 847 (96%) had troponin and BNP concentrations above the limit of detection, respectively. Participants had a slight male preponderance (n=513; 56.1%), and the median age was 59.0 (IQR 51.0-65.0) years. The median troponin and BNP concentrations were 1.4 (IQR 0.90-2.1) ng/L and 29.1 (IQR 14.0-54.0) ng/L, respectively. Age and atherosclerotic burden were independent predictors of both biomarkers. Male sex, left ventricular mass and systolic blood pressure were independent predictors of increased troponin. In contrast, female sex and left ventricular volume were independent predictors of increased BNP.
CONCLUSIONS
Troponin and BNP are associated with coronary atherosclerosis but have important sex differences and distinct and contrasting associations with CT-determined left ventricular mass and volume.
CLINICAL TRIAL REGISTRATION
NCT01149590; Post-results.",2019,"Male sex, left ventricular mass and systolic blood pressure were independent predictors of increased troponin.","['885 patients were included; 881 (99%) and 847 (96%) had troponin and BNP concentrations above the limit of detection, respectively', 'Patients with troponin >99th centile upper reference limit (10.2\u2009ng/L) or BNP ≥400\u2009ng/L were excluded to avoid inclusion of patients with myocardial injury or heart failure', 'stable patients', 'Participants had a slight male preponderance (n=513; 56.1%), and the median age was 59.0 (IQR 51.0-65.0) years', 'patients from six centres in whom high-sensitivity troponin I and BNP were measured (Singulex Erenna', 'patients with stable chest pain', 'enrolled patients 18-75 years with suspected stable angina between 2010 and 2014 (NCT01149590']",[],"['median troponin and BNP concentrations', 'Male sex, left ventricular mass and systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2718050', 'cui_str': 'Limit of Detection'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",885.0,0.138541,"Male sex, left ventricular mass and systolic blood pressure were independent predictors of increased troponin.","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Moss', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'McAllister', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-314892']
789,31655020,Impact of the addition of azithromycin to antimalarials used for seasonal malaria chemoprevention on antimicrobial resistance of Streptococcus pneumoniae.,"OBJECTIVE
A trial was conducted in Burkina Faso and Mali to investigate whether addition of azithromycin to the antimalarials used for seasonal malaria chemoprevention reduces mortality and hospital admissions of children. We tested the sensitivity of nasal isolates of Streptococcus pneumoniae obtained during this trial to azithromycin and other antibiotics.
METHODS
Azithromycin or placebo was administered monthly, in combination with the antimalarials used for seasonal malaria chemoprevention, for four months, over the annual malaria transmission seasons of 2014, 2015, and 2016. Nasopharyngeal swabs were collected from 2773 Burkinabe and 2709 Malian children on seven occasions: in July and December each year prior to and after drug administration, and at a final survey in early 2018. Pneumococci were isolated from nasopharyngeal swabs and tested for sensitivity to azithromycin and other antibiotics.
RESULTS
A total of 5482 samples were collected. In Burkina Faso, the percentage of pneumococcal isolates resistant to azithromycin among children who had received it increased from 4.9% (95% CI: 2.4%, 9.9%) before the intervention to 25.6% (95% CI: 17.6%, 35.7%) afterward. In Mali, the increase was from 7.6% (95% CI: 3.8%, 14.4%) to 68.5% (95% CI: 55.1%, 79.4%). The percentage of resistant isolates remained elevated (17.7% (95% CI: 11.1%, 27.1%) in Burkina Faso and 19.1% (95% CI: 13.5%, 26.3%) in Mali) among children who had received azithromycin 1 year after stopping the intervention. An increase in resistance to azithromycin was also observed in children who had received a placebo but it was less marked.
CONCLUSION
Addition of azithromycin to the antimalarial combination used for seasonal malaria chemoprevention was associated with an increase in resistance of pneumococci to azithromycin and erythromycin, which persisted 1 year after the last administration of azithromycin.",2019,"An increase in resistance to azithromycin was also observed in children who had received a placebo but it was less marked.
","['children', 'Nasopharyngeal swabs were collected from 2773 Burkinabe and 2709 Malian children on seven occasions: in July and December each year prior to and after drug administration, and at a final survey in early 2018']","['placebo', 'azithromycin', 'azithromycin and erythromycin', 'Azithromycin or placebo']","['resistance of pneumococci', 'percentage of resistant isolates', 'antimicrobial resistance of Streptococcus pneumoniae', 'resistance to azithromycin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab (specimen)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",,0.169842,"An increase in resistance to azithromycin was also observed in children who had received a placebo but it was less marked.
","[{'ForeName': 'Soumeya', 'Initials': 'S', 'LastName': 'Hema-Ouangraoua', 'Affiliation': 'Centre MURAZ, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Abdoul', 'Initials': 'A', 'LastName': 'Aziz Maiga', 'Affiliation': 'Centre pour le Développement des Vaccins du Mali, Bamako, Mali.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cairns', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Nikiema', 'Initials': 'N', 'LastName': 'Frédéric', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Rakiswendé', 'Initials': 'R', 'LastName': 'Serge Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Boubou', 'Initials': 'B', 'LastName': 'Tamboura', 'Affiliation': 'Centre pour le Développement des Vaccins du Mali, Bamako, Mali.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Badji', 'Affiliation': 'Centre pour le Développement des Vaccins du Mali, Bamako, Mali.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Gore-Langton', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Centre (MRTC), University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre (MRTC), University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Samba O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Malaria Research and Training Centre (MRTC), University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandrahoman', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bosco Ouedraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13321']
790,31367958,Experimental non-severe hypoglycaemia substantially impairs cognitive function in type 2 diabetes: a randomised crossover trial.,"AIMS/HYPOTHESIS
Previous studies have demonstrated a relationship between cognitive impairment and hypoglycaemia (<3 mmol/l). This study hypothesised that non-severe insulin-induced hypoglycaemia reduces cognitive function in individuals with type 2 diabetes.
METHODS
In this randomised crossover study, 25 participants with type 2 diabetes attended two experimental visits with hyperinsulinaemic glucose clamping: one hypoglycaemic clamp (plasma glucose 3.0 ± 0.2 mmol/l) and one euglycaemic clamp (plasma glucose 6.0 ± 0.2 mmol/l). Participants were eligible if their diabetes was treated with diet or glucose-lowering medications (except sulfonylureas or insulin), age was 35-70 years, BMI was 23-35 kg/m 2 and HbA 1c was below 75 mmol/mol (9%). Cognitive function was assessed with a neurocognitive test battery measuring verbal memory, executive function, sustained attention and psychomotor speed. From the examined cognitive domains, a global cognition score was constructed estimating global cognition. A measurement for psychomotor speed was selected as the primary outcome. Participants and people assessing the outcomes were blinded to group assignment.
RESULTS
Cognitive performance was impaired during hypoglycaemia with a mean score in the primary outcome test, Symbol Digit Modalities Test measuring psychomotor speed, of 48.7 ± 9.8 (hypoglycaemia) vs 56.6 ± 12.0 (euglycaemia); i.e. a change of -7.9 points (95% CI -10.9, -4.9; p < 0.0001). In addition, hypoglycaemia reduced global cognitive score by -0.7 (95% CI -0.9, -0.6; p < 0.0001). A stable glucose plateau was achieved during both experimental visits. For the hypoglycaemic clamp, mean plasma glucose concentration (± SD) during neurocognitive testing was 3.1 (± 0.3) mmol/l. Age, sex, fasting C-peptide, counter-regulatory hormones and the severity of hypoglycaemic symptoms did not influence cognitive function.
CONCLUSIONS/INTERPRETATION
Acute non-severe hypoglycaemia (mean plasma glucose 3.1 mmol/l) has a substantial negative impact on cognitive function in individuals with type 2 diabetes.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03014011.
FUNDING
The study was supported in part by a research grant from the Investigator Initiated Studies Program of Merck Sharp & Dohme Corp (MSD-MA-NORD-007-01). The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp. Funding was also received from Skibsreder Per Henriksen, R. og hustrus Foundation, The Danish Alzheimer Foundation and Savværksejer Jeppe Juhl og hustrus Foundation.",2019,"RESULTS
Cognitive performance was impaired during hypoglycaemia with a mean score in the primary outcome test, Symbol Digit Modalities Test measuring psychomotor speed, of 48.7 ± 9.8 (hypoglycaemia) vs 56.6 ± 12.0 (euglycaemia); i.e. a change of -7.9 points (95% CI -10.9, -4.9; p < 0.0001).","['type 2 diabetes', '25 participants with type 2 diabetes attended two experimental visits with hyperinsulinaemic glucose clamping', 'Participants were eligible if their diabetes was treated with', 'individuals with type 2 diabetes']","['diet or glucose-lowering medications (except sulfonylureas or insulin', 'hypoglycaemic clamp (plasma glucose 3.0\u2009±\u20090.2\xa0mmol/l) and one euglycaemic clamp (plasma glucose 6.0\u2009±\u20090.2\xa0mmol/l']","['hypoglycaemic clamp, mean plasma glucose concentration (± SD', 'hypoglycaemia reduced global cognitive score', 'Cognitive performance', 'neurocognitive test battery measuring verbal memory, executive function, sustained attention and psychomotor speed', 'Cognitive function', 'Symbol Digit Modalities Test measuring psychomotor speed', 'cognitive function']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015159', 'cui_str': 'Glucose Clamping'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}]","[{'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}]",25.0,0.12909,"RESULTS
Cognitive performance was impaired during hypoglycaemia with a mean score in the primary outcome test, Symbol Digit Modalities Test measuring psychomotor speed, of 48.7 ± 9.8 (hypoglycaemia) vs 56.6 ± 12.0 (euglycaemia); i.e. a change of -7.9 points (95% CI -10.9, -4.9; p < 0.0001).","[{'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Endocrinology, Bispebjerg University Hospital, Bispebjerg Bakke 23, 2400, Copenhagen, NV, Denmark. malin.sofia.desiree.nilsson@regionh.dk.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jensen', 'Affiliation': 'Department of Endocrinology, Bispebjerg University Hospital, Bispebjerg Bakke 23, 2400, Copenhagen, NV, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gejl', 'Affiliation': 'Department of Endocrinology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Marianne L', 'Initials': 'ML', 'LastName': 'Bergmann', 'Affiliation': 'Department of Biochemistry and Immunology, University Hospital of Southern Denmark, Vejle, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Storgaard', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Zander', 'Affiliation': 'Department of Endocrinology, Bispebjerg University Hospital, Bispebjerg Bakke 23, 2400, Copenhagen, NV, Denmark.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Miskowiak', 'Affiliation': 'Department of Psychology and Mental Health Services, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Rungby', 'Affiliation': 'Department of Endocrinology, Bispebjerg University Hospital, Bispebjerg Bakke 23, 2400, Copenhagen, NV, Denmark.'}]",Diabetologia,['10.1007/s00125-019-4964-4']
791,31129065,"Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial.","BACKGROUND
Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy.
METHODS
RESTART was a prospective, randomised, open-label, blinded-endpoint, parallel-group trial at 122 hospitals in the UK that assessed whether starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. For this prespecified subgroup analysis, consultant neuroradiologists masked to treatment allocation reviewed brain CT or MRI scans performed before randomisation to confirm participant eligibility and rate features of the intracerebral haemorrhage and surrounding brain. We followed participants for primary (recurrent symptomatic intracerebral haemorrhage) and secondary (ischaemic stroke) outcomes for up to 5 years (reported elsewhere). For this report, we analysed eligible participants with intracerebral haemorrhage according to their treatment allocation in primary subgroup analyses of cerebral microbleeds on MRI and in exploratory subgroup analyses of other features on CT or MRI. The trial is registered with the ISRCTN registry, number ISRCTN71907627.
FINDINGS
Between May 22, 2013, and May 31, 2018, 537 participants were enrolled, of whom 525 (98%) had intracerebral haemorrhage: 507 (97%) were diagnosed on CT (252 assigned to start antiplatelet therapy and 255 assigned to avoid antiplatelet therapy, of whom one withdrew and was not analysed) and 254 (48%) underwent the required brain MRI protocol (122 in the start antiplatelet therapy group and 132 in the avoid antiplatelet therapy group). There were no clinically or statistically significant hazards of antiplatelet therapy on recurrent intracerebral haemorrhage in primary subgroup analyses of cerebral microbleed presence (2 or more) versus absence (0 or 1) (adjusted hazard ratio [HR] 0·30 [95% CI 0·08-1·13] vs 0·77 [0·13-4·61]; p interaction =0·41), cerebral microbleed number 0-1 versus 2-4 versus 5 or more (HR 0·77 [0·13-4·62] vs 0·32 [0·03-3·66] vs 0·33 [0·07-1·60]; p interaction =0·75), or cerebral microbleed strictly lobar versus other location (HR 0·52 [0·004-6·79] vs 0·37 [0·09-1·28]; p interaction =0·85). There was no evidence of heterogeneity in the effects of antiplatelet therapy in any exploratory subgroup analyses (all p interaction >0·05).
INTERPRETATION
Our findings exclude all but a very modest harmful effect of antiplatelet therapy on recurrent intracerebral haemorrhage in the presence of cerebral microbleeds. Further randomised trials are needed to replicate these findings and investigate them with greater precision.
FUNDING
British Heart Foundation.",2019,There were no clinically or statistically significant hazards of antiplatelet therapy on recurrent intracerebral haemorrhage in primary subgroup analyses of cerebral microbleed presence (2 or more) versus absence,"['Between May 22, 2013, and May 31, 2018, 537 participants were enrolled, of whom 525 (98%) had intracerebral haemorrhage: 507 (97%) were diagnosed on CT (252 assigned to start antiplatelet therapy and 255 assigned to avoid antiplatelet therapy, of whom one withdrew and was not analysed) and 254 (48%) underwent the required', 'eligible participants with intracerebral haemorrhage according to their treatment allocation in primary subgroup analyses of cerebral microbleeds on MRI and in exploratory subgroup analyses of other features on CT or MRI', 'intracerebral haemorrhage and cerebral small vessel diseases', '0·13-4·62', 'participants for primary (recurrent symptomatic intracerebral haemorrhage) and secondary (ischaemic stroke) outcomes for up to 5 years (reported elsewhere', '0·004-6·79']","['antiplatelet therapy', 'cerebral microbleed strictly lobar versus other location (HR 0·52', 'brain MRI protocol']","['recurrent intracerebral haemorrhage', 'stroke risk', 'risk of recurrent symptomatic intracerebral haemorrhage']","[{'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C2733158', 'cui_str': 'Cerebral Microangiopathies'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]",537.0,0.211384,There were no clinically or statistically significant hazards of antiplatelet therapy on recurrent intracerebral haemorrhage in primary subgroup analyses of cerebral microbleed presence (2 or more) versus absence,"[{'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK. Electronic address: rustam.al-shahi@ed.ac.uk.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Minks', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Dipayan', 'Initials': 'D', 'LastName': 'Mitra', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK; Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Rodrigues', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Johann C', 'Initials': 'JC', 'LastName': 'du Plessis', 'Affiliation': 'Department of Clinical Neurosciences, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Yogish', 'Initials': 'Y', 'LastName': 'Joshi', 'Affiliation': ""Department of Radiology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Murray', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Peter A G', 'Initials': 'PAG', 'LastName': 'Sandercock', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Division of Clinical Neurosciences, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Stephen', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Cathie L M', 'Initials': 'CLM', 'LastName': 'Sudlow', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Werring', 'Affiliation': 'Stroke Research Group, Department of Brain Repair and Rehabilitation, University College London Queen Square Institute of Neurology, London, UK.'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Whiteley', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Wardlaw', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; UK Dementia Research Institute at the University of Edinburgh, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'White', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK; Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30184-X']
792,31129581,Study protocol for a randomised controlled trial evaluating the effectiveness of strengths model case management (SMCM) with Chinese mental health service users in Hong Kong.,"INTRODUCTION
Strengths-based approaches mobilise individual and environmental resources that can facilitate the recovery of people with mental illness. Strengths model case management (SMCM), developed by Rapp and Goscha through collaborative efforts at the University of Kansas, offers a structured and innovative intervention. As evidence of the effectiveness of strengths-based interventions come from Western studies, which lacked rigorous research design or failed to assure fidelity to the model, we aim to fill these gaps and conduct a randomised controlled trial (RCT) to test the effectiveness of SMCM for individuals with mental illness in Hong Kong.
METHODS AND ANALYSIS
This will be an RCT of SMCM. Assuming a medium intervention effect (Cohen's d=0.60) with 30% missing data (including dropouts), 210 service users aged 18 years or above will be recruited from three community mental health centres. They will be randomly assigned to SMCM groups (intervention) or SMILE groups (control) in a 1:1 ratio. The SMCM groups will receive strengths model interventions from case workers, whereas the SMILE groups will receive generic care from case workers with an attention placebo. The case workers will all be embedded in the community centres and will be required to provide a session with service users in both groups at least once every fortnight. There will be two groups of case workers for the intervention and control groups, respectively. The effectiveness of the SMCM will be compared between the two groups of service users with outcomes at baseline, 6 and 12 months after recruitment. Functional outcomes will also be reported by case workers. Data on working alliances and goal attainment will be collected from individual case workers. Qualitative evaluation will be conducted to identify the therapeutic ingredients and conditions leading to positive outcomes. Trained outcome assessors will be blind to the group allocation.
ETHICS AND DISSEMINATION
Ethical approval from the Human Research Ethics Committee at the University of Hong Kong has been obtained (HRECNCF: EA1703078). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.
TRIAL REGISTRATION NUMBER
12617001435370; Pre-results.",2019,"Assuming a medium intervention effect (Cohen's d=0.60) with 30% missing data (including dropouts), 210 service users aged 18 years or above will be recruited from three community mental health centres.","['210 service users aged 18 years or above will be recruited from three community mental health centres', 'people with mental illness', 'individuals with mental illness in Hong Kong', 'Chinese mental health service users in Hong Kong']","['SMCM', 'placebo', 'strengths model case management (SMCM']",[],"[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}]",[],,0.245971,"Assuming a medium intervention effect (Cohen's d=0.60) with 30% missing data (including dropouts), 210 service users aged 18 years or above will be recruited from three community mental health centres.","[{'ForeName': 'Samson', 'Initials': 'S', 'LastName': 'Tse', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong, HKSAR, China.'}, {'ForeName': 'Sau Man Catalina', 'Initials': 'SMC', 'LastName': 'Ng', 'Affiliation': 'Department of Early Childhood Education, Faculty of Education and Human Development, Education University of Hong Kong, Hong Kong, HKSAR, China.'}, {'ForeName': 'Wing Yan Winnie', 'Initials': 'WYW', 'LastName': 'Yuen', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong, HKSAR, China.'}, {'ForeName': 'Sadaaki', 'Initials': 'S', 'LastName': 'Fukui', 'Affiliation': 'School of Social Work, Indiana University-Purdue University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Goscha', 'Affiliation': 'California Institute for Behavioral Health Solutions, Sacramento, California, USA.'}, {'ForeName': 'Wann Ka Iris', 'Initials': 'WKI', 'LastName': 'Lo', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong, HKSAR, China.'}]",BMJ open,['10.1136/bmjopen-2018-026399']
793,31039759,"Evaluation of the efficacy of an interdialytic ""ethanol 40% v/v - enoxaparin 1000 U/mL"" lock solution to prevent tunnelled catheter infections in chronic hemodialysis patients: a multi-centre, randomized, single blind, parallel group study.","BACKGROUND
Tunnelled dialysis catheter (TC) infections are a major health complication and are associated with increased antibiotic consumption, hospital stays, health costs and mortality. Experimental data provide evidence that Ethenox, a mixture of enoxaparine 1000 U/mL in 40% v/v ethanol, could be a promising lock solution. The aim of the study is to compare an interdialytic lock solution of Ethenox with reference lock solutions, unfractionated heparin (UFH) or citrate 4% for the prevention of TCI in hemodialysis patients.
METHOD
This study will monitor a multicentre, prospective, single blind, randomized, controlled, parallel group trial. The main inclusion criteria are patients > 18 years old with end-stage renal disease, treated with chronic hemodialysis/hemodiafiltration three times a week, with incident or prevalent non-impregnated internal jugular TCs inserted for at least 2 weeks and able to give informed consent. Exclusion criteria are TCI in the previous 4 weeks and anti-infective treatment for TCI in the previous 2 weeks. Patients will be randomized to receive either study treatment Ethenox in the intervention group or reference solutions in the control group, unfractionated heparin (UFH) or citrate 4% w/v according to usual practice. The primary outcome measure will be time to first TCIs assessed by an endpoint adjudication committee blinded to the study arm according to predefined criteria. Patients will receive the study treatment for up to 12 months. Intention-to-treat analysis of the primary endpoint will be performed with a marginal Cox proportional hazard model. Prospective power calculations indicate that the study will have 90% statistical power to detect a clinical significant two-fold increase in median infection-free survival if 200 patients are recruited into each arm over a period of 24 months.
DISCUSSION
Firm evidence of the efficacy of the Ethenox lock in preventing TCI could be of major clinical benefit for patients. The results of this study will allow the development of new guidelines based on a high level of evidence.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03083184 , date of registration March 17 2017 and European Clinical Trials Database Identifier: EudraCT 2016-A00180-51), date of registration July 11 2016.",2019,"DISCUSSION
Firm evidence of the efficacy of the Ethenox lock in preventing TCI could be of major clinical benefit for patients.","['hemodialysis patients', '200 patients', 'chronic hemodialysis patients', 'patients >\u200918\u2009years old with end-stage renal disease, treated with chronic hemodialysis/hemodiafiltration three times a week, with incident or prevalent non-impregnated internal jugular TCs inserted for at least 2\u2009weeks and able to give informed consent']","['unfractionated heparin (UFH) or citrate 4% w/v according to usual practice', 'Tunnelled dialysis catheter (TC', 'interdialytic ""ethanol 40% v/v - enoxaparin 1000\u2009U/mL"" lock solution', 'Ethenox with reference lock solutions, unfractionated heparin (UFH']","['time to first TCIs', 'tunnelled catheter infections', 'antibiotic consumption, hospital stays, health costs and mortality', 'median infection-free survival']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0560267', 'cui_str': 'w/v'}, {'cui': 'C0179747', 'cui_str': 'Dialysis catheter'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0742006', 'cui_str': 'Catheter infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.107849,"DISCUSSION
Firm evidence of the efficacy of the Ethenox lock in preventing TCI could be of major clinical benefit for patients.","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Aniort', 'Affiliation': 'Nephrology, Dialysis and Transplantation Department, Gabriel Montpied University Hospital, 54 rue Montalembert, BP69, 63003, Clermont-Ferrand, Cedex 1, France. janiort@chu-clermontferrand.fr.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Piraud', 'Affiliation': 'Nephrology, Dialysis and Transplantation Department, Gabriel Montpied University Hospital, 54 rue Montalembert, BP69, 63003, Clermont-Ferrand, Cedex 1, France.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Adda', 'Affiliation': 'Medical Intensive Care Unit, Gabriel Montpied University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Perreira', 'Affiliation': 'Biostatistics Unit (DRCI), University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bouiller', 'Affiliation': 'Nephrology and Dialysis Department, Emile Roux Hospital, Le Puy en Velay, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Fourcade', 'Affiliation': 'Nephrology and Dialysis Department, Metropole-Savoie Hospital, Chambery, France.'}, {'ForeName': 'Abdallah', 'Initials': 'A', 'LastName': 'Guerraoui', 'Affiliation': 'Calydial Viennes, Vienne, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Kalbacher', 'Affiliation': 'Nephrology and Dialysis Department, Edouard Herriot University Hospital, Lyon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Krumel', 'Affiliation': 'Nephrology and Dialysis Department, University Hospital, Strasbourg, France.'}, {'ForeName': 'Hélène Leray', 'Initials': 'HL', 'LastName': 'Moragues', 'Affiliation': 'AIDER, Montpellier, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Thibaudin', 'Affiliation': 'Nephrology and Dialysis Department, University Hospital, Saint Etienne, France.'}, {'ForeName': 'Carlos Gustavo', 'Initials': 'CG', 'LastName': 'Vela', 'Affiliation': 'Nephrology and Dialysis Department, Hospital, Perpignan, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Vernin', 'Affiliation': 'AGDUC, La Tronche, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Weclawiak', 'Affiliation': 'Nephrology and Dialysis Department, Médipole Saint-Roch Clinic, Cabestany, France.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'Pharmacy department, Gabriel Montpied University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Anne Elisabeth', 'Initials': 'AE', 'LastName': 'Heng', 'Affiliation': 'Nephrology, Dialysis and Transplantation Department, Gabriel Montpied University Hospital, 54 rue Montalembert, BP69, 63003, Clermont-Ferrand, Cedex 1, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Souweine', 'Affiliation': 'Medical Intensive Care Unit, Gabriel Montpied University Hospital, Clermont-Ferrand, France.'}]",BMC nephrology,['10.1186/s12882-019-1338-6']
794,31892336,Impact of aromatase inhibitor treatment on global gene expression and its association with antiproliferative response in ER+ breast cancer in postmenopausal patients.,"BACKGROUND
Endocrine therapy reduces breast cancer mortality by 40%, but resistance remains a major clinical problem. In this study, we sought to investigate the impact of aromatase inhibitor (AI) therapy on gene expression and identify gene modules representing key biological pathways that relate to early AI therapy resistance.
METHODS
Global gene expression was measured on pairs of core-cut biopsies taken at baseline and at surgery from 254 patients with ER-positive primary breast cancer randomised to receive 2-week presurgical AI (n = 198) or no presurgical treatment (control n = 56) from the POETIC trial. Data from the AI group was adjusted to eliminate artefactual process-related changes identified in the control group. The response was assessed by changes in the proliferation marker, Ki67.
RESULTS
High baseline ESR1 expression associated with better AI response in HER2+ tumours but not HER2- tumours. In HER2- tumours, baseline expression of 48 genes associated with poor antiproliferative response (p < 0.005) including PERP and YWHAQ, the two most significant, and the transcription co-regulators (SAP130, HDAC4, and NCOA7) which were among the top 16 most significant. Baseline gene signature scores measuring cell proliferation, growth factor signalling (ERBB2-GS, RET/GDNF-GS, and IGF-1-GS), and immune activity (STAT1-GS) were significantly higher in poor AI responders. Two weeks of AI caused downregulation of genes involved in cell proliferation and ER signalling, as expected. Signature scores of E2F activation and TP53 dysfunction after 2-week AI were associated with poor AI response in both HER2- and HER2+ patients.
CONCLUSIONS
There is a high degree of heterogeneity in adaptive mechanisms after as little as 2-week AI therapy; however, all appear to converge on cell cycle regulation. Our data support the evaluation of whether an E2F signatures after short-term exposure to AI may identify those patients most likely to benefit from the early addition of CDK4/6 inhibitors.
TRIAL REGISTRATION
ISRCTN, ISRCTN63882543, registered on 18 December 2007.",2019,"In HER2- tumours, baseline expression of 48 genes associated with poor antiproliferative response (p < 0.005) including PERP and YWHAQ, the two most significant, and the transcription co-regulators (SAP130, HDAC4, and NCOA7) which were among the top 16 most significant.","['ER+ breast cancer in postmenopausal patients', 'registered on 18 December 2007', '254 patients with ER-positive primary breast cancer randomised to']","['Endocrine therapy', 'receive 2-week presurgical AI (n\u2009=\u2009198) or no presurgical treatment (control n\u2009=\u200956', 'aromatase inhibitor (AI) therapy', 'aromatase inhibitor treatment']","['breast cancer mortality', 'Baseline gene signature scores measuring cell proliferation, growth factor signalling (ERBB2-GS, RET/GDNF-GS, and IGF-1-GS), and immune activity (STAT1-GS', 'antiproliferative response', 'global gene expression', 'transcription co-regulators (SAP130, HDAC4, and NCOA7', 'PERP and YWHAQ', 'poor AI response', 'Signature scores of E2F activation and TP53 dysfunction', 'AI response']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0207072', 'cui_str': 'Glial Cell Line-Derived Neurotrophic Factor'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",,0.0327853,"In HER2- tumours, baseline expression of 48 genes associated with poor antiproliferative response (p < 0.005) including PERP and YWHAQ, the two most significant, and the transcription co-regulators (SAP130, HDAC4, and NCOA7) which were among the top 16 most significant.","[{'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Breast Cancer Now Research Centre, ICR, London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'López-Knowles', 'Affiliation': 'Breast Cancer Now Research Centre, ICR, London, UK.'}, {'ForeName': 'Maggie Chon U', 'Initials': 'MCU', 'LastName': 'Cheang', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morden', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ribas', 'Affiliation': 'Breast Cancer Now Research Centre, ICR, London, UK.'}, {'ForeName': 'Kally', 'Initials': 'K', 'LastName': 'Sidhu', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Martins', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dodson', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Skene', 'Affiliation': 'Royal Bournemouth Hospital, Castle Lane East, Bournemouth, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Holcombe', 'Affiliation': 'Royal Liverpool University Hospital, 200 London Road, Liverpool, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mallon', 'Affiliation': 'Queen Elizabeth University Hospital Glasgow, Govan, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Poole General Hospital, Longfleet Road, Dorset, UK.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Derby Rd., Nottingham, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Breast Unit, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Lesley-Ann', 'Initials': 'LA', 'LastName': 'Martin', 'Affiliation': 'Breast Cancer Now Research Centre, ICR, London, UK.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'Breast Cancer Now Research Centre, ICR, London, UK. Mitchell.Dowsett@icr.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research : BCR,['10.1186/s13058-019-1223-z']
795,30733268,Clonal evolution in myeloma: the impact of maintenance lenalidomide and depth of response on the genetics and sub-clonal structure of relapsed disease in uniformly treated newly diagnosed patients.,"The emergence of treatment resistant sub-clones is a key feature of relapse in multiple myeloma. Therapeutic attempts to extend remission and prevent relapse include maximizing response and the use of maintenance therapy. We used whole exome sequencing to study the genetics of paired samples taken at presentation and at relapse from 56 newly diagnosed patients, following induction therapy, randomized to receive either lenalidomide maintenance or observation as part of the Myeloma XI trial. Patients included were considered high risk, relapsing within 30 months of maintenance randomization. Patients achieving a complete response had predominantly branching evolutionary patterns leading to relapse, characterized by a greater mutational burden, an altered mutational profile, bi-allelic inactivation of tumor suppressor genes, and acquired structural aberrations. Conversely, in patients achieving a partial response, the evolutionary features were predominantly stable with a similar mutational and structural profile seen at both time points. There were no significant differences between patients relapsing after lenalidomide maintenance versus observation. This study shows that the depth of response is a key determinant of the evolutionary patterns seen at relapse. This trial is registered at clinicaltrials.gov identifier: 01554852 .",2019,"Patients achieving a complete response had predominantly branching evolutionary patterns leading to relapse, characterized by a greater mutational burden, an altered mutational profile, bi-allelic inactivation of tumor suppressor genes, and acquired structural aberrations.","['uniformly treated newly diagnosed patients', '56 newly diagnosed patients']",['lenalidomide maintenance or observation'],[],"[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",[],,0.072599,"Patients achieving a complete response had predominantly branching evolutionary patterns leading to relapse, characterized by a greater mutational burden, an altered mutational profile, bi-allelic inactivation of tumor suppressor genes, and acquired structural aberrations.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Jones', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Weinhold', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Ashby', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Walker', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wardell', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Rasche', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Melchor', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, UK.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Dil B', 'Initials': 'DB', 'LastName': 'Begum', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Sidra', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Sherborne', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Leeds Institute of Cancer and Pathology, University of Leeds, UK.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Kaiser', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology, School of Immunity and Infection, University of Birmingham, UK.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': 'Leeds Institute of Cancer and Pathology, University of Leeds, UK.'}, {'ForeName': 'Graham H', 'Initials': 'GH', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Davies', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Greaves', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Morgan', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA gjmorgan@uams.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Haematologica,['10.3324/haematol.2018.202200']
796,32122153,Active chest tube clearance after aortic valve surgery did not influence amount residual pericardial fluid after aortic valve replacement in a randomised trial.,"Objective. Evaluate if the use of active clearance of chest tubes after aortic valve surgery influenced bleeding and reduced postoperative residual pericardial effusion. Design. Prospective randomised trial comparing PleuraFlow ® 32 F chest tube with FlowGlide™ active clearance to a standard Argyle ® 32 F chest tube in 100 patients undergoing aortic valve surgery. Chest tube outputs and pericardial effusion measurements assessed by two-dimensional transthoracic echocardiography were recorded before hospital discharge. Results. Postoperative chest tube outputs per hour did not differ between the two groups. The median chest tube output was 400 mL for patients who had a PleuraFlow ® chest tube vs . 490 mL for patients with an Argyle ® chest tube ( p = .08). Pericardial effusions ≥ 2 mm were detected in 76% vs. 68% of the patients ( p = .50) and postoperative atrial fibrillation occurred in 42% vs . 34% ( p = .54), respectively. Conclusions. Use of active clearance chest tubes, compared to standard chest tubes after aortic valve surgery did not differ significantly regarding postoperative bleeding or degree of pericardial effusion as measured by echocardiography prior to hospital discharge.",2020,"Use of active clearance chest tubes, compared to standard chest tubes after aortic valve surgery did not differ significantly regarding postoperative bleeding or degree of pericardial effusion as measured by echocardiography prior to hospital discharge.",['100 patients undergoing aortic valve surgery'],['PleuraFlow ® 32\u2009F chest tube with FlowGlide™ active clearance to a standard Argyle ® 32\u2009F chest tube'],"['Postoperative chest tube outputs per hour', 'postoperative atrial fibrillation', 'postoperative bleeding or degree of pericardial effusion', 'median chest tube output']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0349077', 'cui_str': 'Pericardial effusion - noninflammatory (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",100.0,0.0694004,"Use of active clearance chest tubes, compared to standard chest tubes after aortic valve surgery did not differ significantly regarding postoperative bleeding or degree of pericardial effusion as measured by echocardiography prior to hospital discharge.","[{'ForeName': 'Linnéa', 'Initials': 'L', 'LastName': 'Malgerud', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Maret', 'Affiliation': 'Department of Clinical Physiology, Karolinska University Hospital, and Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reitan', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm and Department of Cardiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Ivert', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.'}]",Scandinavian cardiovascular journal : SCJ,['10.1080/14017431.2020.1728373']
797,31142536,Accounting for health literacy and intervention preferences when reducing unhealthy snacking: protocol for an online randomised controlled trial.,"INTRODUCTION
Health literacy describes the cognitive and social skills that individuals use to access, understand and act on health information. Health literacy interventions typically take the 'universal precautions approach' where all consumers are presented with simplified materials. Although this approach can improve knowledge and comprehension, its impact on complex behaviours is less clear. Systematic reviews also suggest that health literacy interventions underuse volitional strategies (such as planning) that play an important role in behaviour change. A recent study found volitional strategies may need to be tailored to the participant's health literacy. The current study aims to replicate these findings in a sample of people who have diabetes and/or are overweight or obese as measured by body mass index, and to investigate the most effective method of allocating an action plan to a participant to reduce unhealthy snacking.
METHODS AND ANALYSIS
We plan to recruit approximately 2400 participants at baseline. Participants will receive one of two alternative online action plans intended to reduce unhealthy snacking ('standard' action plan or 'literacy-sensitive' action plan). Participants will be randomised to a method of allocation to an action plan: (1) random allocation; (2) allocation by health literacy screening tool or (3) allocation by participant selection. Primary outcome is self-reported serves of unhealthy snacks during the previous month. Multiple linear regression will evaluate the impact of health literacy on intervention effectiveness. The analysis will also identify independent contributions of each action plan, method of allocation, health literacy and participant selections on unhealthy snacking at 4-week follow-up.
ETHICS AND DISSEMINATION
This study was approved by the University of Sydney Human Research Ethics Committee (2017/793). Findings will be disseminated through peer-reviewed international journals, conferences and updates with collaborating public health bodies (Diabetes New South Wales (NSW) & Australian Capital Territory (ACT), and Western Sydney Local Health District).
TRIAL REGISTRATION NUMBER
ACTRN12618001409268; Pre-results.",2019,Participants will receive one of two alternative online action plans intended to reduce unhealthy snacking ('standard' action plan or 'literacy-sensitive' action plan).,"['people who have diabetes and/or are overweight or obese', '2400 participants at baseline']","['action plan: (1) random allocation; (2) allocation by health literacy screening tool or (3) allocation by participant selection', ""alternative online action plans intended to reduce unhealthy snacking ('standard' action plan or 'literacy-sensitive' action plan""]",['self-reported serves of unhealthy snacks'],"[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}]","[{'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}]",,0.113128,Participants will receive one of two alternative online action plans intended to reduce unhealthy snacking ('standard' action plan or 'literacy-sensitive' action plan).,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ayre', 'Affiliation': 'Faculty of Medicine and Health, Sydney School of Public Health, Sydney Health Literacy Lab, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cvejic', 'Affiliation': 'Faculty of Medicine and Health, Sydney School of Public Health, Sydney Health Literacy Lab, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Carissa', 'Initials': 'C', 'LastName': 'Bonner', 'Affiliation': 'Faculty of Medicine and Health, Sydney School of Public Health, Sydney Health Literacy Lab, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Turner', 'Affiliation': 'Division of Health Sciences, Biostatistics Unit, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Walter', 'Affiliation': 'Faculty of Health Sciences, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kirsten J', 'Initials': 'KJ', 'LastName': 'McCaffery', 'Affiliation': 'Faculty of Medicine and Health, Sydney School of Public Health, Sydney Health Literacy Lab, The University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-028544']
798,30606789,Six months versus two years of oral anticoagulation after a first episode of unprovoked deep-vein thrombosis. The PADIS-DVT randomized clinical trial.,"The optimal duration of anticoagulation after a first episode of unprovoked deep-vein thrombosis is uncertain. We aimed to assess the benefits and risks of an additional 18 months of treatment with warfarin versus placebo, after an initial 6 months of anticoagulation for a first unprovoked proximal deep-vein thrombosis. We conducted a multicenter, randomized, double-blind, controlled trial comparing an additional 18 months of warfarin with placebo in patients with a unprovoked proximal deep-vein thrombosis initially treated for 6 months (treatment period: 18 months; follow up after treatment period: 24 months). The primary outcome was the composite of recurrent venous thromboembolism or major bleeding at 18 months. Secondary outcomes were the composite at 42 months, as well as each component of the composite, and death unrelated to pulmonary embolism or major bleeding, at 18 and 42 months. All outcomes were centrally adjudicated. A total of 104 patients, enrolled between July 2007 and October 2013 were analyzed on an intention-to-treat basis; no patient was lost to follow-up. During the 18-month treatment period, the primary outcome occurred in none of the 50 patients in the warfarin group and in 16 out of 54 patients (cumulative risk, 29.6%) in the placebo group (hazard ratio, 0.03; 95% confidence interval: 0.01 to 0.09; P <0.001). During the entire 42-month study period, the composite outcome occurred in 14 patients (cumulative risk, 36.8%) in the warfarin group and 17 patients (cumulative risk, 31.5%) in the placebo group (hazard ratio, 0.72; 95% confidence interval: 0.35-1.46). In conclusion, after a first unprovoked proximal deep-vein thrombosis initially treated for 6 months, an additional 18 months of warfarin therapy reduced the composite of recurrent venous thrombosis and major bleeding compared to placebo. However, this benefit was not maintained after stopping anticoagulation. Clinical registration: this trial was registered at www.clinicaltrials.gov as #NCT00740493 .",2019,"During the 18-month treatment period, the primary outcome occurred in none of the 50 patients in the warfarin group and in 16 out of 54 patients (cumulative risk, 29.6%) in the placebo group (hazard ratio, 0.03; 95% confidence interval: 0.01 to 0.09; P <0.001).","['patients with a unprovoked proximal deep-vein thrombosis initially treated for 6 months (treatment period: 18 months; follow up after treatment period: 24 months', '104 patients, enrolled between July 2007 and October 2013 were analyzed on an intention-to-treat basis; no patient was lost to follow-up']","['placebo', 'warfarin with placebo', 'warfarin versus placebo', 'warfarin therapy', 'warfarin']","['composite at 42 months, as well as each component of the composite, and death unrelated to pulmonary embolism or major bleeding', 'composite of recurrent venous thromboembolism or major bleeding', 'composite of recurrent venous thrombosis and major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C4303340', 'cui_str': 'Warfarin therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}]",104.0,0.608676,"During the 18-month treatment period, the primary outcome occurred in none of the 50 patients in the warfarin group and in 16 out of 54 patients (cumulative risk, 29.6%) in the placebo group (hazard ratio, 0.03; 95% confidence interval: 0.01 to 0.09; P <0.001).","[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Départementde Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest francis.couturaud@chu-brest.fr.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pernod', 'Affiliation': 'Département de Médecine Vasculaire, CHU de Grenoble, Université de Grenoble 1, F-CRIN INNOVTE, Grenoble.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Presles', 'Affiliation': 'Unité de Recherche Clinique, Innovation et Pharmacologie, CHU de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, F-CRIN INNOVTE, Saint-Etienne.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Duhamel', 'Affiliation': 'Service de Médecine Interne, Centre Hospitalier Général de Saint-Brieuc, F-CRIN INNOVTE, Saint-Brieuc.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jego', 'Affiliation': 'Service de Médecine Interne, CHU de Rennes, Université de Rennes 1, Rennes.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Provost', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier Général de Lannion, Lannion.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Pan-Petesch', 'Affiliation': ""Service d'Hématologie, Centre Hospitalier Général de Quimper, Quimper.""}, {'ForeName': 'Claire Bal Dit', 'Initials': 'CBD', 'LastName': 'Sollier', 'Affiliation': ""Clinique des Anticoagulants d'Ile de France (C.R.E.A.T.I.F.), CHU de Lariboisière, Paris.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tromeur', 'Affiliation': 'Départementde Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': ""Service d'Echo-Doppler Vasculaire, and EA 3878, CIC INSERM 1412, CHU de Brest, Université de Bretagne Occidentale, F-CRIN INNOVTE, Brest.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bressollette', 'Affiliation': ""Service d'Echo-Doppler Vasculaire, and EA 3878, CIC INSERM 1412, CHU de Brest, Université de Bretagne Occidentale, F-CRIN INNOVTE, Brest.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lorillon', 'Affiliation': 'Pharmacie Centrale, CHU de Brest, Université de Bretagne Occidentale, Brest.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'Département Thoracique, Institut Mutualiste Montsouris, F-CRIN INNOVTE, Paris.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Le Moigne', 'Affiliation': 'Départementde Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Le Hir', 'Affiliation': 'Départementde Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Guégan', 'Affiliation': 'Départementde Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest.'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'Laporte', 'Affiliation': 'Unité de Recherche Clinique, Innovation et Pharmacologie, CHU de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, F-CRIN INNOVTE, Saint-Etienne.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, CHU de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, F-CRIN INNOVTE, Saint-Etienne.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Lacut', 'Affiliation': 'Départementde Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'CIC and UMR CNRS 5525, CHU de Grenoble, Université de Grenoble 1, Grenoble, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bertoletti', 'Affiliation': 'Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, CHU de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, F-CRIN INNOVTE, Saint-Etienne.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sanchez', 'Affiliation': 'CIC and UMR CNRS 5525, CHU de Grenoble, Université de Grenoble 1, Grenoble, France.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'CIC and UMR CNRS 5525, CHU de Grenoble, Université de Grenoble 1, Grenoble, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leroyer', 'Affiliation': 'Départementde Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Mottier', 'Affiliation': 'Départementde Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Haematologica,['10.3324/haematol.2018.210971']
799,30870779,Oxytocin alters patterns of brain activity and amygdalar connectivity by age during dynamic facial emotion identification.,"Aging is associated with increased difficulty in facial emotion identification, possibly due to age-related network change. The neuropeptide oxytocin (OT) facilitates emotion identification, but this is understudied in aging. To determine the effects of OT on dynamic facial emotion identification across adulthood, 46 young and 48 older participants self-administered intranasal OT or a placebo in a randomized, double-blind procedure. Older participants were slower and less accurate in identifying emotions. Although there was no behavioral treatment effect, partial least squares analysis supported treatment effects on brain patterns during emotion identification that varied by age and emotion. For young participants, OT altered the processing of sadness and happiness, whereas for older participants, OT only affected the processing of sadness (15.3% covariance, p = 0.004). Furthermore, seed partial least squares analysis showed that older participants in the OT group recruited a large-scale amygdalar network that was positively correlated for anger, fear, and happiness, whereas older participants in the placebo group recruited a smaller, negatively correlated network (7% covariance, p = 0.002). Advancing the literature, these findings show that OT alters brain activity and amygdalar connectivity by age and emotion.",2019,"Furthermore, seed partial least squares analysis showed that older participants in the OT group recruited a large-scale amygdalar network that was positively correlated for anger, fear, and happiness, whereas older participants in the placebo group recruited a smaller, negatively correlated network (7% covariance, p = 0.002).","['Older participants', 'across adulthood, 46 young and 48 older participants self-administered']","['neuropeptide oxytocin (OT', 'intranasal OT or a placebo', 'OT', 'Oxytocin']","['dynamic facial emotion identification', 'brain activity and amygdalar connectivity', 'anger, fear, and happiness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}]",46.0,0.150374,"Furthermore, seed partial least squares analysis showed that older participants in the OT group recruited a large-scale amygdalar network that was positively correlated for anger, fear, and happiness, whereas older participants in the placebo group recruited a smaller, negatively correlated network (7% covariance, p = 0.002).","[{'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Horta', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, FL, USA. Electronic address: mhorta09@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ziaei', 'Affiliation': 'Centre for Advanced Imaging, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Porges', 'Affiliation': 'Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feifel', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'R Nathan', 'Initials': 'RN', 'LastName': 'Spreng', 'Affiliation': 'Department of Neurology and Neurosurgery, Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada; Departments of Psychology and Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Ebner', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, FL, USA; Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, University of Florida, Gainesville, FL, USA; Department of Aging and Geriatric Research, Institute on Aging, University of Florida, Gainesville, FL, USA.'}]",Neurobiology of aging,['10.1016/j.neurobiolaging.2019.01.016']
800,30871812,Sex-based differences in transfusion need after severe injury: Findings of the PROPPR study.,"BACKGROUND
Women are underrepresented in trauma research, and aggregated results of clinical trials may mask effects that differ by sex. It is unclear whether women respond differently to severe hemorrhage compared with men. We sought to evaluate sex-based differences in outcomes after severe trauma with hemorrhage.
METHODS
We performed a secondary analysis of the Pragmatic Randomized Optimal Platelet and Plasma Ratios trial. Trauma patients predicted to require massive transfusion were randomized to a 1:1:1 vs 1:1:2 plasma to platelet to red blood cell transfusion ratio. Analysis was performed according to sex, controlling for clinical characteristics and transfusion arm.
RESULTS
A total of 134 women and 546 men were analyzed. In multivariable analysis, there was no difference in mortality at 24 hours (hazard ratio for women 0.64, 95% confidence interval 0.34-1.23, P = .18) or in time to hemostasis (hazard ratio 1.10, 95% confidence interval 0.84-1.42, P = .49) by sex. We observed no difference between sexes in volume of blood products transfused during active hemorrhage. However, after anatomic hemostasis, women received lower volumes of all products, with a 38% reduction in fresh frozen plasma (mean ratio 0.62 (95% confidence interval 0.43-0.89, P = .01), 49% reduction in platelets (mean ratio 0.51, 95% confidence interval 0.33-0.79, P < .01) and 49% reduction in volume of red blood cells (mean ratio 0.51, 95% confidence interval 0.33-0.79, P < .01).
CONCLUSION
Mortality and time to hemostasis of trauma patients with hemorrhage did not differ by sex. Although there was no difference in transfusion requirement during active hemorrhage, once hemostasis was achieved, women received fewer units of all blood products than men. Further research is required to determine whether women exhibit differences in coagulation during and after severe traumatic hemorrhage.",2019,"In multivariable analysis, there was no difference in mortality at 24 hours (hazard ratio for women 0.64, 95% confidence interval 0.34-1.23, P = .18) or in time to hemostasis (hazard ratio 1.10, 95% confidence interval 0.84-1.42, P = .49) by sex.","['Trauma patients predicted to require massive transfusion', '134 women and 546 men were analyzed']",[],"['volume of red blood cells', 'transfusion requirement', 'fresh frozen plasma', 'mortality', 'time to hemostasis']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",134.0,0.619464,"In multivariable analysis, there was no difference in mortality at 24 hours (hazard ratio for women 0.64, 95% confidence interval 0.34-1.23, P = .18) or in time to hemostasis (hazard ratio 1.10, 95% confidence interval 0.84-1.42, P = .49) by sex.","[{'ForeName': 'Marta L', 'Initials': 'ML', 'LastName': 'McCrum', 'Affiliation': 'Department of Surgery, University of Utah, Salt Lake City, UT. Electronic address: marta.mccrum@hsc.utah.edu.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leroux', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Tingzhi', 'Initials': 'T', 'LastName': 'Fang', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bulger', 'Affiliation': 'Department of Surgery, University of Washington, Seattle, WA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Arbabi', 'Affiliation': 'Department of Surgery, University of Washington, Seattle, WA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': 'Department of Surgery, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Fox', 'Affiliation': 'Department of Surgery, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Department of Surgery, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Bryce', 'Initials': 'B', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Washington, Seattle, WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Surgery,['10.1016/j.surg.2018.12.023']
801,31043453,Diabetes-Related Emotional Distress Over Time.,"BACKGROUND AND OBJECTIVES
Many adolescents with type 1 diabetes experience diabetes-related distress (DRD; the negative emotional reactions specific to managing diabetes), but most research on DRD among adolescents relies on cross-sectional data. We assess adolescents' longitudinal DRD patterns and predictors of chronic DRD.
METHODS
This secondary analysis of data from a depression prevention clinical trial included 264 adolescents with type 1 diabetes randomly assigned to a resilience or education intervention (mean age: 15.7 ± 1.1 years; 59.8% female). Youth reported their DRD at 5 assessments over 16 months. Using latent class growth analysis, we classified adolescents into trajectory groups according to baseline starting point (intercept) and rate of change (slope) of DRD. We examined bivariate associations between trajectory group membership and demographic and clinical factors. Baseline predictors of chronic DRD were assessed via multiple logistic regression.
RESULTS
Participants were classified into 4 groups: stable high DRD (7.2%; high intercept, flat slope), stable moderate DRD (28.0%; above-average intercept, flat slope), improving DRD (33.7%; average intercept, downward slope), and low DRD (31.1%; below-average intercept, downward slope). Lower hemoglobin A1c, greater adherence, fewer socioemotional difficulties, and more adaptive coping distinguished the improving and low DRD trajectories. Chronic DRD patterns were associated with female sex and higher depressive symptoms and hemoglobin A1c.
CONCLUSIONS
In this study of adolescents' DRD trajectories during and after a psychoeducational intervention, one-third of youth were classified as having chronic, elevated DRD. Links with multiple clinical factors support efforts for routine DRD screening and comprehensive interventions for distressed youth.",2019,"Lower hemoglobin A1c, greater adherence, fewer socioemotional difficulties, and more adaptive coping distinguished the improving and low DRD trajectories.","['distressed youth', '264 adolescents with type 1 diabetes randomly assigned to a resilience or education intervention (mean age: 15.7 ± 1.1 years; 59.8% female', 'Many adolescents with type 1 diabetes experience diabetes-related distress (DRD']",[],"['low DRD', 'Chronic DRD patterns', 'DRD', 'Diabetes-Related Emotional Distress', 'stable high DRD', 'stable moderate DRD', 'Lower hemoglobin A1c, greater adherence, fewer socioemotional difficulties, and more adaptive coping distinguished the improving and low DRD trajectories', 'chronic DRD']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",264.0,0.0272428,"Lower hemoglobin A1c, greater adherence, fewer socioemotional difficulties, and more adaptive coping distinguished the improving and low DRD trajectories.","[{'ForeName': 'Esti', 'Initials': 'E', 'LastName': 'Iturralde', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Rausch', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Weissberg-Benchell', 'Affiliation': ""Department of Psychiatry and Behavioral Sciences, Ann & Robert H. Lurie Children's Hospital of Chicago, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.""}, {'ForeName': 'Korey K', 'Initials': 'KK', 'LastName': 'Hood', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford University, Stanford, California; kkhood@stanford.edu.'}]",Pediatrics,['10.1542/peds.2018-3011']
802,31818831,Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol.,"INTRODUCTION
Anti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidence that adherence to these cardiovascular medications is far from ideal. A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients.
METHODS AND ANALYSIS
The txt2heart study is a pragmatic randomised single-blind controlled trial. The objective is to evaluate the efficacy and safety of an intervention with SMS messages delivered by mobile phones to improve adherence to cardiovascular medications in patients with ASCVD. The intervention consists of behavioural techniques delivered via SMS. The primary outcome is change in blood serum low-density lipoprotein cholesterol levels as an indicator of adherence to statins. Secondary outcomes will include systolic blood pressure as an indicator of adherence to blood-lowering therapies and heart rate as an indicator of adherence to beta-blockers, urine levels of 11 -dehydrothromboxane B2, self-reported adherence to cardiovascular medications and rates of cardiovascular death or hospitalisation due to cardiovascular disease.
ETHICS AND DISSEMINATION
The study will be performed in compliance with the protocol, regulatory requirements, Good Clinical Practice and ethical principles of the Declaration of Helsinki. The Ethics Committee of Fundación Cardiovascular de Colombia evaluated and approved the trial. The txt2heart Colombia trial aims to provide robust evidence to evaluate whether SMS messages delivered through mobile telephones change the behaviour of Colombian patients who have suffered a cardiovascular event. Trial results will be presented to the local health authorities, and if the intervention is effective and safe, we hope this strategy will be implemented quickly because of its low cost and wide-reaching impact on the population.
TRIAL REGISTRATION NUMBER
NCT03098186.",2019,"A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients.
","['secondary prevention', 'ASCVD patients', 'patients with ASCVD', 'patients with atherosclerotic cardiovascular diseases (ASCVD', 'Colombian patients who have suffered a cardiovascular event']","['Short Message Service (SMS) interventions', 'angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins']","['change in blood serum low-density lipoprotein cholesterol levels', 'efficacy and safety', 'systolic blood pressure as an indicator of adherence to blood-lowering therapies and heart rate as an indicator of adherence to beta-blockers, urine levels of 11 -dehydrothromboxane B2, self-reported adherence to cardiovascular medications and rates of cardiovascular death or hospitalisation due to cardiovascular disease']","[{'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C3178909'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0014432', 'cui_str': 'Enzyme Inhibitors'}, {'cui': 'C0003011', 'cui_str': 'Receptor, Angiotensin II'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005768'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0042037'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0044728', 'cui_str': 'Thromboxa-5,13-dien-1-oic acid, 9,15-dihydroxy-11-oxo-, (5Z,9alpha,13E,15S)-'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",,0.279682,"A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients.
","[{'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Bermon', 'Affiliation': 'Research, Fundacion Cardiovascular de Colombia, Floridablanca, Santander, Colombia andersonbermon@fcv.org.'}, {'ForeName': 'Ana Fernanda', 'Initials': 'AF', 'LastName': 'Uribe-Rodríguez', 'Affiliation': 'Faculty of Psychology, Universidad Pontificia Bolivariana - Seccional Bucaramanga, Floridablanca, Santander, Colombia.'}, {'ForeName': 'Paula Fernanda', 'Initials': 'PF', 'LastName': 'Pérez-Rivero', 'Affiliation': 'Faculty of Psychology, Universidad Pontificia Bolivariana - Seccional Bucaramanga, Floridablanca, Santander, Colombia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Prieto-Merino', 'Affiliation': 'EPH LSHTM, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Diana Isabel', 'Initials': 'DI', 'LastName': 'Cáceres Rivera', 'Affiliation': 'Nursing, Universidad Cooperativa de Colombia, Bucaramanga, Santander, Colombia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Guio', 'Affiliation': 'Metabolism and Genoma Laboratory, Fundacion Cardiovascular de Colombia, Floridablanca, Santander, Colombia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Atkins', 'Affiliation': 'University College London Research Department of Epidemiology and Public Health, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'University College London School of Pharmacy, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'University College London Research Department of Primary Care and Population Health, London, UK.'}, {'ForeName': 'Norma Cecilia', 'Initials': 'NC', 'LastName': 'Serrano Díaz', 'Affiliation': 'Direction of Research, Fundación Cardiovascular de Colombia, Bucaramanga, Santander, Colombia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'EPH LSHTM, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Perel', 'Affiliation': 'EPH LSHTM, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Casas', 'Affiliation': 'Research, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2018-028017']
803,31826890,"Prevalence and correlates of depressive symptoms among gay, bisexual and other men who have sex with men in the PROUD randomised clinical trial of HIV pre-exposure prophylaxis.","OBJECTIVES
The aim of this analysis is to: (i) assess the prevalence of clinically significant depressive symptoms at baseline and follow-up for participants in the PROUD trial of HIV pre-exposure prophylaxis (PrEP), examining changes in prevalence over time and (ii) investigate the association of socioeconomic and psychosocial factors with depression.
METHODS
PROUD was an open label randomised trial evaluating the benefit of PrEP for 544 HIV-negative gay, bisexual and other men who have sex with men (GBMSM) in England. Enrolment was between 2012 and 2014, with at least 2 years follow-up. Prevalence of depression (score ≥10 on Patient Health Questionnaire-9) was assessed and compared across time-points (using McNemar's χ 2 tests) and between trial arms (using χ 2 tests). Cross-sectional associations with socioeconomic and psychosocial factors were examined using baseline data in modified Poisson regression models and combined 12 and 24 month follow-up data in generalised estimating equations (GEEs). Prevalence ratios (PRs) were presented as unadjusted PR and adjusted PR (aPR) for age, UK birth, sexual identity, university education, London study clinic site and calendar time (and follow-up time-point in GEEs).
RESULTS
Depression increased significantly from baseline (9.1%; 49/540) to the 12 month (14.4%; 59/410) and 24 month (14.4%; 48/333) follow-ups, possibly explained by underreporting at baseline. The prevalence of depression did not differ by study trial arm, at any time-point. In the baseline analysis, younger age, unemployment and crystal methamphetamine use, was associated with depression. In combined analysis of 12 and 24 month data, measures of intimate partner violence (IPV) (lifetime IPV victimisation aPR 2.57 (95% CI: 1.71 to 3.86)), internalised homophobia (aPR 1.91 (95% CI: 1.29 to 2.83)) and concealment of sexual identity (aPR 1.75 (95% CI: 1.16 to 2.65)), were strongly associated with depression.
CONCLUSIONS
There is a high concomitant burden of psychosocial factors with depression among GBMSM.
TRIAL REGISTRATION NUMBER
ISRCTN (ISRCTN94465371) and ClinicalTrials.gov (NCT02065986).",2019,"RESULTS
Depression increased significantly from baseline (9.1%; 49/540) to the 12 month (14.4%; 59/410) and 24 month (14.4%; 48/333) follow-ups, possibly explained by underreporting at baseline.","['gay, bisexual and other men who have sex with men', '544 HIV-negative gay, bisexual and other men who have sex with men (GBMSM) in England']","['HIV pre-exposure prophylaxis (PrEP', 'PrEP']","['Prevalence ratios (PRs', 'internalised homophobia', 'Depression', 'concealment of sexual identity', 'depressive symptoms', 'prevalence of depression', 'intimate partner violence (IPV', 'Prevalence of depression (score ≥10 on Patient Health Questionnaire-9']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1096319', 'cui_str': 'HIV pre-exposure prophylaxis'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0680423', 'cui_str': 'Anti-Homosexual Bias'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",544.0,0.234697,"RESULTS
Depression increased significantly from baseline (9.1%; 49/540) to the 12 month (14.4%; 59/410) and 24 month (14.4%; 48/333) follow-ups, possibly explained by underreporting at baseline.","[{'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Miltz', 'Affiliation': 'Institute for Global Health, University College London, London, UK Ada.Miltz.11@ucl.ac.uk.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lampe', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'McCormack', 'Affiliation': 'MRC CTU, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunn', 'Affiliation': 'MRC CTU, University College London, London, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'White', 'Affiliation': 'MRC CTU, University College London, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Sherr', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Ann K', 'Initials': 'AK', 'LastName': 'Sullivan', 'Affiliation': 'Chelsea and Westminster Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Reeves', 'Affiliation': 'Homerton University Hospital NHS Trust, London, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Brighton & Sussex University Hospital NHS Trust, Brighton & Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Mitzy', 'Initials': 'M', 'LastName': 'Gafos', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031085']
804,32100468,Cardiomyopathy and kidney function in agalsidase beta-treated female Fabry patients: a pre-treatment vs. post-treatment analysis.,"AIMS
Long-term treatment effect studies in large female Fabry patient groups are challenging to design because of phenotype heterogeneity and lack of appropriate comparison groups, and have not been reported. We compared long-term cardiomyopathy and kidney function outcomes after agalsidase beta treatment with preceding treatment-naive outcomes.
METHODS AND RESULTS
Self-controlled pretreatment and post-treatment comparison (piecewise mixed linear modelling) included Fabry female patients ≥18 years at treatment initiation who received agalsidase beta (0.9-1.1 mg/kg every other week) for ≥2 years, with ≥2 pretreatment and ≥2 post-treatment outcome measurements during 10-year follow-up. Left ventricular posterior wall thickness (LVPWT)/interventricular septal thickness (IVST) and estimated glomerular filtration rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration creatinine equation) analyses included 42 and 86 patients, respectively, aged 50.0 and 46.3 years at treatment initiation, respectively. LVPWT and IVST increased pretreatment (follow-up 3.5 years) but stabilized during 3.6 years of treatment (LVPWT: n = 38, slope difference [95% confidence interval (CI)] = -0.41 [-0.68, -0.15] mm/year, P pre-post difference <0.01; IVST: n = 38, slope difference = -0.32 [-0.67, 0.02] mm/year, P pre-post difference = 0.07). These findings were not modified by renal involvement or antiproteinuric agent use. Compared with the treatment-naive period (follow-up 3.6 years), eGFR decline remained modest and stabilized within normal ranges during 4.1 years of treatment (slope difference, 95% CI: -0.13 [-1.15, 0.89] mL/min/1.73m 2 /year, P pre-post difference = 0.80).
CONCLUSIONS
Cardiac hypertrophy, progressing during pretreatment follow-up, appeared to stabilize during sustained agalsidase beta treatment. eGFR decline remained within normal ranges. This suggests that treatment may prevent further Fabry-related progression of cardiomyopathy in female patients and maintain normal kidney function.",2020,"Compared with the treatment-naive period (follow-up 3.6 years), eGFR decline remained modest and stabilized within normal ranges during 4.1 years of treatment (slope difference, 95% CI: -0.13","['large female Fabry patient groups', 'agalsidase beta-treated female Fabry patients', '42 and 86 patients, respectively, aged 50.0 and 46.3\xa0years at treatment initiation, respectively', 'female patients and maintain normal kidney function', 'Fabry female patients ≥18\xa0years at treatment initiation who received agalsidase beta (0.9-1.1\xa0mg/kg every other week) for ≥2\xa0years, with ≥2 pretreatment and ≥2 post-treatment outcome measurements during 10-year follow-up']","['Self-controlled pretreatment and post-treatment comparison (piecewise mixed linear modelling', 'LVPWT and IVST']","['Left ventricular posterior wall thickness (LVPWT)/interventricular septal thickness (IVST) and estimated glomerular filtration rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration creatinine equation', 'eGFR decline', 'Cardiomyopathy and kidney function']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1137427', 'cui_str': 'agalsidase beta'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0085415'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0442071', 'cui_str': 'Posterior wall (qualifier value)'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0814081,"Compared with the treatment-naive period (follow-up 3.6 years), eGFR decline remained modest and stabilized within normal ranges during 4.1 years of treatment (slope difference, 95% CI: -0.13","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Division of Nephrology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Medical Endocrinology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Jovanovic', 'Affiliation': 'The Mark Holland Unit, Department of Endocrinology and Metabolic Medicine, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Aleš', 'Initials': 'A', 'LastName': 'Linhart', 'Affiliation': '2nd Department of Medicine, Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University, General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Epidemiology & Biostatistics, Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Ponce', 'Affiliation': 'Global Medical Affairs Rare Diseases, Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Brand', 'Affiliation': 'Internal Medicine D, Department of\xa0Nephrology, Hypertension and Rheumatology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Dominique P', 'Initials': 'DP', 'LastName': 'Germain', 'Affiliation': 'French Referral Center for Fabry Disease, Division of Medical Genetics and INSERM U1179, University of Versailles, Paris-Saclay University, Montigny, France.'}, {'ForeName': 'Derralynn A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Lysosomal Storage Disorder Unit, Royal Free London NHS Foundation Trust and, University College London, London, UK.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Jefferies', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Diseases, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Martins', 'Affiliation': 'Department of Paediatrics, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Albina', 'Initials': 'A', 'LastName': 'Nowak', 'Affiliation': 'Department of Internal Medicine, University Hospital of Zürich, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Bojan', 'Initials': 'B', 'LastName': 'Vujkovac', 'Affiliation': 'Department of Internal Medicine, General Hospital Slovenj Gradec, Slovenj Gradec, Slovenia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Weidemann', 'Affiliation': 'Medical Clinic I, Klinikum Vest, Knappschaftskrankenhaus, Recklinghausen, Germany.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'West', 'Affiliation': 'Department of Medicine, Division of Nephrology, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Unidad de Dialisis, IIS-Fundación Jiménez Díaz, UAM, IRSIN, REDINREN, Madrid, Spain.'}]",ESC heart failure,['10.1002/ehf2.12647']
805,31116355,Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial.,"Importance
The PCSK9 inhibitor evolocumab reduced low-density lipoprotein cholesterol and first cardiovascular events in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, but patients remain at high risk of recurrent cardiovascular events.
Objective
To evaluate the effect of evolocumab on total cardiovascular events, given the importance of total number of cardiovascular events to patients, clinicians, and health economists.
Design, Setting, and Participants
Secondary analysis of a randomized, double-blind clinical trial. The FOURIER trial compared evolocumab or matching placebo and followed up patients for a median of 2.2 years. The study included 27 564 patients with stable atherosclerotic disease receiving statin therapy. Data were analyzed between May 2017 and February 2019.
Main Outcomes and Measures
The primary end point (PEP) was time to first cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; the key secondary end point was time to first cardiovascular death, myocardial infarction, or stroke. In a prespecified analysis, total cardiovascular events were evaluated between treatment arms.
Results
The mean age of patients was 63 years, 69% of patients were taking high-intensity statin therapy, and the median LDL-C at baseline was 92 mg/dL (to convert to millimoles per liter, multiply by 0.0259). There were 2907 first PEP events and 4906 total PEP events during the trial. Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85). There were 2192 total primary events in the evolocumab group and 2714 total events in the placebo group. For every 1000 patients treated for 3 years, evolocumab prevented 22 first PEP events and 52 total PEP events. Reductions in total events were driven by fewer total myocardial infarctions (RR, 0.74; 95% CI, 0.65-0.84; P < .001), strokes (RR, 0.77; 95% CI, 0.64-0.93; P = .007), and coronary revascularizations (RR, 0.78; 95% CI, 0.71-0.87; P < .001).
Conclusions and Relevance
The addition of the PCSK9 inhibitor evolocumab to statin therapy improved clinical outcomes, with significant reductions in total PEP events, driven by decreases in myocardial infarction, stroke, and coronary revascularization. More than double the number of events were prevented with evolocumab vs placebo as compared with the analysis of only first events. These data provide further support for the benefit of continuing aggressive lipid-lowering therapy to prevent recurrent cardiovascular events.
Trial Registration
ClinicalTrials.gov identifier: NCT01764633.",2019,"Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85).","['27\u202f564 patients with stable atherosclerotic disease receiving statin therapy', 'Patients With Cardiovascular Disease']","['placebo', 'evolocumab or matching placebo', 'evolocumab', 'PCSK9 Inhibitor Evolocumab', 'evolocumab vs placebo']","['strokes', 'total events', 'total myocardial infarctions', 'total PEP events', 'total cardiovascular events', 'coronary revascularizations', '4906 total PEP events', 'Total Cardiovascular Events', 'low-density lipoprotein cholesterol and first cardiovascular events', 'time to first cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; the key secondary end point was time to first cardiovascular death, myocardial infarction, or stroke', 'myocardial infarction, stroke, and coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",27564.0,0.375442,"Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85).","[{'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Zbigniew A', 'Initials': 'ZA', 'LastName': 'Gaciong', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ceska', 'Affiliation': 'Center for Preventive Cardiology, 3rd Internal Medicine Clinic, University General Hospital and Charles University 1st Medical Faculty, Prague, Czech Republic.'}, {'ForeName': 'Marat V', 'Initials': 'MV', 'LastName': 'Ezhov', 'Affiliation': 'National Cardiology Research Center, Moscow, Russia.'}, {'ForeName': 'Derek L', 'Initials': 'DL', 'LastName': 'Connolly', 'Affiliation': 'Birmingham City and Sandwell Hospitals and the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, England.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Kalman', 'Initials': 'K', 'LastName': 'Toth', 'Affiliation': 'First Department of Medicine, University of Pecs, Medical School, Pecs, Hungary.'}, {'ForeName': 'Matti J', 'Initials': 'MJ', 'LastName': 'Tikkanen', 'Affiliation': 'Folkhälsan Research Center, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kyungah', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'Imperial College London, London, England.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2019.0886']
806,31054484,Evacetrapib reduces preβ-1 HDL in patients with atherosclerotic cardiovascular disease or diabetes.,"BACKGROUND AND AIMS
Cholesteryl ester transfer protein (CETP) inhibitor-mediated induction of HDL-cholesterol has no effect on the protection from cardiovascular disease (CVD). However, the mechanism is still unknown. Data on the effects of this class of drugs on subclasses of HDL are either limited or insufficient. In this study, we investigated the effect of evacetrapib, a CETP inhibitor, on subclasses of HDL in patients with atherosclerotic cardiovascular disease or diabetes.
METHODS
Baseline and 3-month post-treatment samples from atorvastatin 40 mg plus evacetrapib 130 mg (n = 70) and atorvastatin 40 mg plus placebo (n = 30) arms were used for this purpose. Four subclasses of HDL (large HDL, medium HDL, small HDL, and preβ-1 HDL) were separated according to their size and quantified by densitometry using a recently developed native polyacrylamide gel electrophoresis (PAGE) system.
RESULTS
Relative to placebo, while evacetrapib treatment dramatically increased large HDL and medium HDL subclasses, it significantly reduced small HDL (27%) as well as preβ-1 HDL (36%) particles. Evacetrapib treatment reduced total LDL, but also resulted in polydisperse LDL with LDL particles larger and smaller than the LDL subclasses of the placebo group.
CONCLUSION
Evacetrapib reduced preβ-1 HDL and small HDL in patients with ASCVD or diabetes on statin. Preβ-1 HDL and medium HDL are negatively interrelated. The results could give a clue to understand the effect of CETP inhibitors on cardiovascular outcomes.",2019,(CETP) inhibitor-mediated induction of HDL-cholesterol has no effect on the protection from cardiovascular disease (CVD).,"['patients with ASCVD or diabetes on statin', 'patients with atherosclerotic cardiovascular disease or diabetes']","['placebo', 'Cholesteryl ester transfer protein', 'atorvastatin 40\u202fmg plus evacetrapib 130\u202fmg (n\u202f=\u202f70) and atorvastatin', 'Evacetrapib', 'CETP inhibitors', 'evacetrapib, a CETP inhibitor']","['small HDL', 'preβ-1 HDL and small HDL', 'cardiovascular outcomes', 'total LDL', 'large HDL and medium HDL subclasses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol Ester Transport Protein, CETP'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3252279', 'cui_str': 'evacetrapib'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}]",,0.0551246,(CETP) inhibitor-mediated induction of HDL-cholesterol has no effect on the protection from cardiovascular disease (CVD).,"[{'ForeName': 'Yunqin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cell Biology, SUNY Downstate Medical Center, Brooklyn, NY, USA; Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'School of Pharmacy, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaojin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Obstetrics & Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Haozhu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: ge.junbo@zs-hospital.sh.cn.'}, {'ForeName': 'Xian-Cheng', 'Initials': 'XC', 'LastName': 'Jiang', 'Affiliation': 'Department of Cell Biology, SUNY Downstate Medical Center, Brooklyn, NY, USA; School of Pharmacy, Fudan University, Shanghai, China. Electronic address: XJiang@downstate.edu.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2019.04.211']
807,31076476,"TEST (Trial of Eczema allergy Screening Tests): protocol for feasibility randomised controlled trial of allergy tests in children with eczema, including economic scoping and nested qualitative study.","BACKGROUND
Early onset eczema is associated with food allergy, and allergic reactions to foods can cause acute exacerbations of eczema. Parents often pursue dietary restrictions as a way of managing eczema and seek allergy testing for their children to guide dietary management. However, it is unclear whether test-guided dietary management improves eczema symptoms, and whether the practice causes harm through reduced use of conventional eczema treatment or unnecessary dietary restrictions. The aim of the Trial of Eczema allergy Screening Tests Study is to determine the feasibility of conducting a trial comparing food allergy testing and dietary advice versus usual care, for the management of eczema in children.
METHODS AND ANALYSIS
Design: A single centre, two-group, individually randomised, feasibility randomised controlled trial (RCT) with economic scoping and a nested qualitative study.
SETTING
General Practioner (GP) surgeries in the west of England.
PARTICIPANTS
children aged over 3 months and less than 5 years with mild to severe eczema.
INTERVENTIONS
allergy testing (structured allergy history and skin prick tests) or usual care. Sample size and outcome measures: we aim to recruit 80 participants and follow them up using 4-weekly questionnaires for 24 weeks. Nested qualitative study: We will conduct ~20 interviews with parents of participating children, 5-8 interviews with parents who decline or withdraw from the trial and ~10 interviews with participating GPs. Economic scoping: We will gather data on key costs and outcomes to assess the feasibility of carrying out a cost-effectiveness analysis in a future definitive trial.
ETHICS AND DISSEMINATION
The study has been reviewed by the Health Research Authority and given a favourable opinion by the NHS REC (West Midlands - South Birmingham Research Ethics Committee, Reference Number 18/WM/0124). Findings will be submitted for presentation at conferences and written up for publication in peer-reviewed journals, which may include mixed-method triangulation and integration of the quantitative and qualitative findings.
TRIAL REGISTRATION
ISRCTN15397185; Pre-results.",2019,"A single centre, two-group, individually randomised, feasibility randomised controlled trial (RCT) with economic scoping and a nested qualitative study.
","['children with eczema, including economic scoping and nested qualitative study', 'General Practioner (GP) surgeries in the west of England', 'eczema in children', 'children aged over 3 months and less than 5 years with mild to severe eczema', '20 interviews with parents of participating children, 5-8 interviews with parents who decline or withdraw from the trial and ~10 interviews with participating GPs']","['allergy testing (structured allergy history and skin prick tests) or usual care', 'food allergy testing and dietary advice versus usual care', 'Economic scoping']",['eczema symptoms'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}]","[{'cui': 'C0549104', 'cui_str': 'In vivo test of hypersensitivity (procedure)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0013557', 'cui_str': 'economics'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",80.0,0.188155,"A single centre, two-group, individually randomised, feasibility randomised controlled trial (RCT) with economic scoping and a nested qualitative study.
","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ridd', 'Affiliation': 'Population Health, University of Bristol, Bristol, UK.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Edwards', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Santer', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre for Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Waddell', 'Affiliation': 'Nottingham CityCare, Nottingham, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Marriage', 'Affiliation': 'Bristol Royal Hospital for Children, Bristol, UK.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Muller', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Roberts', 'Affiliation': 'Population Health, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Coast', 'Affiliation': 'Health Economics at Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Selman', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Clement', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alison R G', 'Initials': 'ARG', 'LastName': 'Shaw', 'Affiliation': 'Population Health, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Angier', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Centre for Academic Child Health, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Turner', 'Affiliation': 'Health Economics at Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Kai', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Boyle', 'Affiliation': 'Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028428']
808,31806540,"Olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B): a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND
Metastatic castration-resistant prostate cancer is enriched in DNA damage response (DDR) gene aberrations. The TOPARP-B trial aims to prospectively validate the association between DDR gene aberrations and response to olaparib in metastatic castration-resistant prostate cancer.
METHODS
In this open-label, investigator-initiated, randomised phase 2 trial following a selection (or pick-the-winner) design, we recruited participants from 17 UK hospitals. Men aged 18 years or older with progressing metastatic castration-resistant prostate cancer previously treated with one or two taxane chemotherapy regimens and with an Eastern Cooperative Oncology Group performance status of 2 or less had tumour biopsies tested with targeted sequencing. Patients with DDR gene aberrations were randomly assigned (1:1) by a computer-generated minimisation method, with balancing for circulating tumour cell count at screening, to receive 400 mg or 300 mg olaparib twice daily, given continuously in 4-week cycles until disease progression or unacceptable toxicity. Neither participants nor investigators were masked to dose allocation. The primary endpoint of confirmed response was defined as a composite of all patients presenting with any of the following outcomes: radiological objective response (as assessed by Response Evaluation Criteria in Solid Tumors 1.1), a decrease in prostate-specific antigen (PSA) of 50% or more (PSA50) from baseline, or conversion of circulating tumour cell count (from ≥5 cells per 7·5 mL blood at baseline to <5 cells per 7·5 mL blood). A confirmed response in a consecutive assessment after at least 4 weeks was required for each component. The primary analysis was done in the evaluable population. If at least 19 (43%) of 44 evaluable patients in a dose cohort responded, then the dose cohort would be considered successful. Safety was assessed in all patients who received at least one dose of olaparib. This trial is registered at ClinicalTrials.gov, NCT01682772. Recruitment for the trial has completed and follow-up is ongoing.
FINDINGS
711 patients consented for targeted screening between April 1, 2015, and Aug 30, 2018. 161 patients had DDR gene aberrations, 98 of whom were randomly assigned and treated (49 patients for each olaparib dose), with 92 evaluable for the primary endpoint (46 patients for each olaparib dose). Median follow-up was 24·8 months (IQR 16·7-35·9). Confirmed composite response was achieved in 25 (54·3%; 95% CI 39·0-69·1) of 46 evaluable patients in the 400 mg cohort, and 18 (39·1%; 25·1-54·6) of 46 evaluable patients in the 300 mg cohort. Radiological response was achieved in eight (24·2%; 11·1-42·3) of 33 evaluable patients in the 400 mg cohort and six (16·2%; 6·2-32·0) of 37 in the 300 mg cohort; PSA50 response was achieved in 17 (37·0%; 23·2-52·5) of 46 and 13 (30·2%; 17·2-46·1) of 43; and circulating tumour cell count conversion was achieved in 15 (53·6%; 33·9-72·5) of 28 and 13 (48·1%; 28·7-68·1) of 27. The most common grade 3-4 adverse event in both cohorts was anaemia (15 [31%] of 49 patients in the 300 mg cohort and 18 [37%] of 49 in the 400 mg cohort). 19 serious adverse reactions were reported in 13 patients. One death possibly related to treatment (myocardial infarction) occurred after 11 days of treatment in the 300 mg cohort.
INTERPRETATION
Olaparib has antitumour activity against metastatic castration-resistant prostate cancer with DDR gene aberrations, supporting the implementation of genomic stratification of metastatic castration-resistant prostate cancer in clinical practice.
FUNDING
Cancer Research UK, AstraZeneca, Prostate Cancer UK, the Prostate Cancer Foundation, the Experimental Cancer Medicine Centres Network, and the National Institute for Health Research Biomedical Research Centres.",2020,"Confirmed composite response was achieved in 25 (54·3%; 95% CI 39·0-69·1) of 46 evaluable patients in the 400 mg cohort, and 18 (39·1%; 25·1-54·6) of 46 evaluable patients in the 300 mg cohort.","['recruited participants from 17 UK hospitals', '161 patients had DDR gene aberrations, 98 of whom were randomly assigned and treated (49 patients for each olaparib dose), with 92 evaluable for the primary endpoint (46 patients for each olaparib dose', 'Patients with DDR gene aberrations', 'metastatic castration-resistant prostate cancer', 'patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B', 'Men aged 18 years or older with progressing metastatic castration-resistant prostate cancer previously treated with one or two taxane chemotherapy regimens and with an Eastern Cooperative Oncology Group performance status of 2 or less had tumour biopsies tested with targeted sequencing', '711 patients consented for targeted screening between April 1, 2015, and Aug 30, 2018']",['Olaparib'],"['prostate-specific antigen (PSA) of 50% or more (PSA50) from baseline, or conversion of circulating tumour cell count', 'anaemia', 'PSA50 response', 'Radiological response', 'radiological objective response', '19 serious adverse reactions', 'circulating tumour cell count conversion', 'Safety', 'composite response']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0012899', 'cui_str': 'DNA Repair'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",711.0,0.409267,"Confirmed composite response was achieved in 25 (54·3%; 95% CI 39·0-69·1) of 46 evaluable patients in the 400 mg cohort, and 18 (39·1%; 25·1-54·6) of 46 evaluable patients in the 300 mg cohort.","[{'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': ""The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Bianchini', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'McGovern', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Elliott', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow and Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'The Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Ralph', 'Affiliation': ""St James's Institute of Oncology, University of Leeds, Leeds, UK.""}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Queen's University, Belfast, UK.""}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Varughese', 'Affiliation': 'Musgrove Park Hospital, Taunton, UK.'}, {'ForeName': 'Omi', 'Initials': 'O', 'LastName': 'Parikh', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Crabb', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Royal Sussex County Hospital, Brighton, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'McLaren', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Lancaster Infirmary, Lancaster, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Tanguay', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Miranda', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Figueiredo', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Seed', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bertan', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Flohr', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Berni', 'Initials': 'B', 'LastName': 'Ebbs', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Rescigno', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Fowler', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ferreira', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Riisnaes', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Pereira', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Curcean', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chandler', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Gurel', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nava Rodrigues', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter McCallum Cancer Center, Melbourne, VIC, Australia.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Espinasse', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chatfield', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Tunariu', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Carreira', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK. Electronic address: johann.de-bono@icr.ac.uk.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30684-9']
809,30703667,"Two- and three-year follow-up from a gender-specific, web-based drug abuse prevention program for adolescent girls.","INTRODUCTION
Rates of drug use among early adolescent girls meet or exceed rates of their male counterparts. Girls are also vulnerable to differential risk factors for drug use. Yet, expressly designed prevention programs targeting this population are absent. The present study reports 2- and 3-year findings on a web-based drug abuse prevention program for adolescent girls.
METHODS
A sample of adolescent girls (N = 788) were recruited via Facebook. Online, all girls completed pretests; girls were randomly assigned to a 9-session intervention arm or to a measurement-only control arm and all girls completed posttests. All girls also completed 1-, 2-, and 3-year follow-up measurements.
RESULTS
At 2-year follow-up and compared to girls in the control arm, intervention-arm girls reported less past-month cigarette, marijuana, and ""other"" drug use (club drugs, cocaine, ecstasy, hallucinogens, heroin, inhalants, methamphetamines, steroids, prescription drugs), lower rates of peer drug use, and increased scores on drug refusal skills, coping skills, self-esteem, media literacy, and self-efficacy. At 3-year follow-up, and compared to girls in the control arm, intervention-arm girls reported less past-month cigarette and e-cigarette use, lower rates of peer drug use, lower reported anxiety and stress, and increased scores on drug refusal skills, self-esteem, media literacy, self-efficacy, and body image.
CONCLUSIONS
Longitudinal outcome data lend support to the efficacy of a gender-specific, web-based drug abuse prevention program to reduce adolescent girls' drug use rates and associated risk factors.",2019,"At 3-year follow-up, and compared to girls in the control arm, intervention-arm girls reported less past-month cigarette and e-cigarette use, lower rates of peer drug use, lower reported anxiety and stress, and increased scores on drug refusal skills, self-esteem, media literacy, self-efficacy, and body image.
","['early adolescent girls', 'adolescent girls', 'A sample of adolescent girls (N\u202f=\u202f788) were recruited via Facebook']","['9-session intervention arm or to a measurement-only control arm and all girls completed posttests', 'web-based drug abuse prevention program']","['drug refusal skills, coping skills, self-esteem, media literacy, and self-efficacy', 'past-month cigarette and e-cigarette use, lower rates of peer drug use, lower reported anxiety and stress, and increased scores on drug refusal skills, self-esteem, media literacy, self-efficacy, and body image']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1171189', 'cui_str': 'Drug abuse prevention'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]",788.0,0.0291591,"At 3-year follow-up, and compared to girls in the control arm, intervention-arm girls reported less past-month cigarette and e-cigarette use, lower rates of peer drug use, lower reported anxiety and stress, and increased scores on drug refusal skills, self-esteem, media literacy, self-efficacy, and body image.
","[{'ForeName': 'Traci Marie', 'Initials': 'TM', 'LastName': 'Schwinn', 'Affiliation': 'Columbia University School of Social Work, 1255 Amsterdam Ave, NY, NY 10027, USA. Electronic address: tms40@columbia.edu.'}, {'ForeName': 'Steven Paul', 'Initials': 'SP', 'LastName': 'Schinke', 'Affiliation': 'Columbia University School of Social Work, 1255 Amsterdam Ave, NY, NY 10027, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Keller', 'Affiliation': 'Teachers College, Columbia University, 525 West 120th St., New York, NY 10027, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hopkins', 'Affiliation': 'Columbia University School of Social Work, 1255 Amsterdam Ave, NY, NY 10027, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.01.010']
810,31983312,"Orthostatic Hypotension, Cardiovascular Outcomes, and Adverse Events: Results From SPRINT.","Orthostatic hypotension (OH) is frequently observed with hypertension treatment, but its contribution to adverse outcomes is unknown. The SPRINT (Systolic Blood Pressure Intervention Trial) was a randomized trial of adults, age ≥50 years at high risk for cardiovascular disease with a seated systolic blood pressure (BP) of 130 to 180 mm Hg and a standing systolic BP ≥110 mm Hg. Participants were randomized to a systolic BP treatment goal of either <120 or <140 mm Hg. OH was defined as a drop in systolic BP ≥20 or diastolic BP ≥10 mm Hg 1 minute after standing from a seated position. We used Cox models to examine the association of OH with cardiovascular disease or adverse study events by randomized BP goal. During the follow-up period (median 3years), there were 1170 (5.7%) instances of OH among those assigned a standard BP goal and 1057 (5.0%) among those assigned the intensive BP goal. OH was not associated with higher risk of cardiovascular disease events (primary outcome: hazard ratio 1.06 [95% CI, 0.78-1.44]). Moreover, OH was not associated with syncope, electrolyte abnormalities, injurious falls, or acute renal failure. OH was associated with hypotension-related hospitalizations or emergency department visits (hazard ratio, 1.77 [95% CI, 1.11-2.82]) and bradycardia (hazard ratio, 1.94 [95% CI, 1.19-3.15]), but these associations did not differ by BP treatment goal. OH was not associated with a higher risk of cardiovascular disease events, and BP treatment goal had no effect on OH's association with hypotension and bradycardia. Symptomless OH during hypertension treatment should not be viewed as a reason to down-titrate therapy even in the setting of a lower BP goal. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01206062.",2020,"OH was associated with hypotension-related hospitalizations or emergency department visits (hazard ratio, 1.77 [95% CI, 1.11-2.82]) and bradycardia (hazard ratio, 1.94","['adults, age ≥50 years at high risk for cardiovascular disease with a seated systolic blood pressure (BP) of 130 to 180 mm Hg and a standing systolic BP ≥110 mm Hg']",[],"['syncope, electrolyte abnormalities, injurious falls, or acute renal failure', 'Orthostatic Hypotension, Cardiovascular Outcomes, and Adverse Events', 'Orthostatic hypotension (OH', 'systolic BP ≥20 or diastolic BP ≥10 mm', 'hypotension-related hospitalizations or emergency department visits', 'bradycardia', 'cardiovascular disease events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",[],"[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.211047,"OH was associated with hypotension-related hospitalizations or emergency department visits (hazard ratio, 1.77 [95% CI, 1.11-2.82]) and bradycardia (hazard ratio, 1.94","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'From the Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (S.P.J.).'}, {'ForeName': 'Addison A', 'Initials': 'AA', 'LastName': 'Taylor', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center and Department of Medicine, Baylor College of Medicine, Houston, TX (A.A.T.).'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH (J.T.W.).'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Evans', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (G.W.E.).'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD (E.R.M., L.J.A.).'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Larner College of Medicine at The University of Vermont, Burlington (T.B.P.).'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Preventive Medicine Section, Memphis VA Medical Center, Memphis, TN (W.C.C.).'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Gure', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Department of Internal Medicine, The Ohio State University, Columbus (T.R.G.).'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, FL (W.E.H.).'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Moinuddin', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, College of Medicine, IL (I.M.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nord', 'Affiliation': 'Department of Internal Medicine; Salt Lake City VA Medical Center, UT (J.N.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham (S.O.).'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Pedley', 'Affiliation': 'Department of Internal Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC (C.P.).'}, {'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'Institute for Medicine and Public Health, Vanderbilt University Medical Center, VA Geriatric Research Education and Clinical Center, Nashville, TN (C.L.R.).'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Whittle', 'Affiliation': 'Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Wiggers', 'Affiliation': 'Department of Primary Care, Ohio University Heritage College of Osteopathic Medicine, Cleveland (A.W.).'}, {'ForeName': 'Ciarán', 'Initials': 'C', 'LastName': 'Finucane', 'Affiliation': ""Department of Medical Physics, Mercer's Institute for Successful Ageing, St James's Hospital, Dublin, Ireland (C.F.).""}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Anne Kenny', 'Affiliation': ""Mercer's Institute for Successful Ageing, St James's Hospital, Dublin, Ireland (R.A.K.).""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD (E.R.M., L.J.A.).'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania (R.R.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.14309']
811,30196720,Improving Patient-Provider Communication and Therapeutic Practice Through Better Integration of Electronic Health Records in the Exam Room: A Pilot Study.,"BACKGROUND
The rapid proliferation of electronic health records (EHRs) in clinics has had mixed impact on patient-centered communication, yet few evaluated interventions exist to train practicing providers in communication practices.
AIMS
We extended the evidence-based Physician Asthma Care Education (PACE) program with EHR-specific communication strategies, and tested whether training providers with the extended program (EHR-PACE) would improve provider and patient perceptions of provider communication skills and asthma outcomes of patients.
METHOD
A pilot randomized design was used to compare EHR-PACE with usual care. Participants were providers ( n = 18) and their adult patients with persistent asthma ( n = 126). Outcomes were assessed at baseline and 3- and 6-month postintervention, including patient perception of their provider's communication skills and provider confidence in using EHRs during clinical encounters.
RESULTS
Compared with the control group, providers who completed the EHR-PACE program reported significant improvements at 3-month follow-up in their confidence with asthma counseling practices (estimate 0.90, standard error [ SE] 0.4); p < .05) and EHR-specific communication practices (estimate 2.3, SE 0.8; p < .01), and at 6-month follow-up, a significant decrease in perception that the computer interferes with the patient-provider relationship (estimate -1.0, SE 0.3; p < .01). No significant changes were observed in patient asthma outcomes or their perception of their provider's communication skills.
DISCUSSION
Training providers with skills to accommodate EHR use in the exam room increases provider confidence and their perceived skills in maintaining patient-centered communications in the short term.
CONCLUSION
Evidence-supported training initiatives that can increase capacity of busy providers to manage increased computing demands shows promise. More research is needed to fully evaluate EHR-PACE on patients' health status and their perceptions of their provider's care through a large-scale trial.",2019,"No significant changes were observed in patient asthma outcomes or their perception of their provider's communication skills.
","['Participants were providers ( n = 18) and their adult patients with persistent asthma ( n = 126', 'patients']",['training providers with the extended program (EHR-PACE'],"['EHR-specific communication practices', ""patient perception of their provider's communication skills and provider confidence in using EHRs during clinical encounters"", ""patient asthma outcomes or their perception of their provider's communication skills""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",126.0,0.0267886,"No significant changes were observed in patient asthma outcomes or their perception of their provider's communication skills.
","[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': '1 University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': '1 University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Leo', 'Affiliation': '1 University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': '1 University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': '2 University of California Irvine, CA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198118796879']
812,32149378,Effectiveness of Sexual Skills Training Program on Promoting Sexual Intimacy and Satisfaction in Women in Tehran (Iran): A randomized clinical Trial Study.,"PURPOSE
The purpose of this study was to evaluate the effectiveness of sexual skills training on intimacy and sexual satisfaction in women.
MATERIALS AND METHODS
This is a randomized clinical trial study with parallel design. 70 participants (n=35 each) were divided into 2 groups as control and intervention groups. Women were selected in multiple steps. Some requirements for inclusion criteria were: obtaining a standard score of marital satisfaction, women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian. Some factors for exclusion criteria were: women's absence in more than 2 training classes, pregnancy during the study. Data collection was conducted through four questionnaires: demographic characteristics, marital satisfaction, sexual satisfaction and sexual intimacy. Validity and reliability of the questionnaires were measured through content validity and Chronbach Alpha, respectively. The data extracted from the questionnaires were analyzed using SPSS software, version 18.0. For data analysis, descriptive statistics, independent t-test, paired t-test, or non-parametric tests were applied. Significance level of the test was considered p<0.05.
RESULTS
The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
CONCLUSION
In total, the training lessons gave positive views to participants towards their sexual issues so that they formed realistic and positive sexual expectations, healthier sexual behaviors and self-expressions and consequently, gained more sexual knowledge that made them able to experience more intimacy and satisfaction in sexual relationships with their spouses.",2020,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","['women', 'Women in Tehran (Iran', 'women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian', '70 participants (n=35 each']","['Sexual Skills Training Program', 'sexual skills training']","['intimacy and sexual satisfaction', 'sexual satisfaction (p<0.001) and sexual intimacy', 'Sexual Intimacy and Satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",70.0,0.054477,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Salehi Moghaddam', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. fatemehsalehi28@yahoo.com.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'TorkZahrani', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Moslemi', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Arak University of Medical Sciences ,Arak, Iran.'}, {'ForeName': 'Seyyed Ali', 'Initials': 'SA', 'LastName': 'Azin', 'Affiliation': 'MD, MPH, FECSM, Reproductive Biotechnology Research Center, Avicenna Research Institute, \nACECR, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Ozgoli', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Joulaee Rad', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4690']
813,31804680,Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions: A Randomized Clinical Trial.,"Importance
Malignant pleural effusion (MPE) is challenging to manage. Talc pleurodesis is a common and effective treatment. There are no reliable data, however, regarding the optimal method for talc delivery, leading to differences in practice and recommendations.
Objective
To test the hypothesis that administration of talc poudrage during thoracoscopy with local anesthesia is more effective than talc slurry delivered via chest tube in successfully inducing pleurodesis.
Design, Setting, and Participants
Open-label, randomized clinical trial conducted at 17 UK hospitals. A total of 330 participants were enrolled from August 2012 to April 2018 and followed up until October 2018. Patients were eligible if they were older than 18 years, had a confirmed diagnosis of MPE, and could undergo thoracoscopy with local anesthesia. Patients were excluded if they required a thoracoscopy for diagnostic purposes or had evidence of nonexpandable lung.
Interventions
Patients randomized to the talc poudrage group (n = 166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation, while patients randomized to the control group (n = 164) underwent bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry.
Main Outcomes and Measures
The primary outcome was pleurodesis failure up to 90 days after randomization. Secondary outcomes included pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life at 30, 90, and 180 days; all-cause mortality; and percentage of opacification on chest radiograph at drain removal and at 30, 90, and 180 days.
Results
Among 330 patients who were randomized (mean age, 68 years; 181 [55%] women), 320 (97%) were included in the primary outcome analysis. At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]). No statistically significant differences were noted in any of the 24 prespecified secondary outcomes.
Conclusions and Relevance
Among patients with malignant pleural effusion, thoracoscopic talc poudrage, compared with talc slurry delivered via chest tube, resulted in no significant difference in the rate of pleurodesis failure at 90 days. However, the study may have been underpowered to detect small but potentially important differences.
Trial Registration
ISRCTN Identifier: ISRCTN47845793.",2019,"At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]).","['Patients were eligible if they were older than 18 years, had a confirmed diagnosis of MPE, and could undergo thoracoscopy with local anesthesia', 'Patients With Malignant Pleural Effusions', '330 patients who were randomized (mean age, 68 years', 'patients with malignant pleural effusion, thoracoscopic talc poudrage', 'Patients were excluded if they required a thoracoscopy for diagnostic purposes or had evidence of nonexpandable lung', '330 participants were enrolled from August 2012 to April 2018 and followed up until October 2018']","['Talc pleurodesis', 'talc poudrage group (n\u2009=\u2009166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation', 'Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube', 'talc poudrage', 'bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry']","['Pleurodesis Failure Rate', 'pleurodesis failure rate', 'rate of pleurodesis failure', 'pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life', 'pleurodesis failure', 'cause mortality; and percentage of opacification on chest radiograph at drain removal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0405997', 'cui_str': 'Talc pleurodesis (procedure)'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0189476', 'cui_str': 'Tube thoracostomy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449584', 'cui_str': 'Opacification (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}]",330.0,0.381216,"At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]).","[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Bhatnagar', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Hania E G', 'Initials': 'HEG', 'LastName': 'Piotrowska', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Laskawiec-Szkonter', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Brennan C', 'Initials': 'BC', 'LastName': 'Kahan', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Luengo-Fernandez', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Justin C T', 'Initials': 'JCT', 'LastName': 'Pepperell', 'Affiliation': 'Somerset Lung Centre, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, United Kingdom.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Evison', 'Affiliation': 'North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Holme', 'Affiliation': 'North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Al-Aloul', 'Affiliation': 'North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Lungs for Living Research Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Respiratory Medicine, Nottingham University Hospitals NHS Trust, United Kingdom.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Glasgow Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Roberts', 'Affiliation': 'Respiratory Department, Sherwood Forest Hospitals Trust, United Kingdom.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Cox', 'Affiliation': 'Respiratory Department, Sherwood Forest Hospitals Trust, United Kingdom.'}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Downer', 'Affiliation': 'Respiratory Department, Sherwood Forest Hospitals Trust, United Kingdom.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Herre', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Pasupathy', 'Initials': 'P', 'LastName': 'Sivasothy', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Glan Clwyd Hospital, North Wales, United Kingdom.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Munavvar', 'Affiliation': 'Lancashire Teaching Hospitals NHS, Foundation Trust, Preston, United Kingdom.'}, {'ForeName': 'Moe M', 'Initials': 'MM', 'LastName': 'Kyi', 'Affiliation': 'Respiratory Department, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Doncaster, United Kingdom.'}, {'ForeName': 'Liju', 'Initials': 'L', 'LastName': 'Ahmed', 'Affiliation': ""Respiratory Department, Guy's and St Thomas' NHS Trust, London, United Kingdom.""}, {'ForeName': 'Alex G', 'Initials': 'AG', 'LastName': 'West', 'Affiliation': ""Respiratory Department, Guy's and St Thomas' NHS Trust, London, United Kingdom.""}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Harrison', 'Affiliation': 'Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, United Kingdom.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': 'Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, United Kingdom.'}, {'ForeName': 'Gihan', 'Initials': 'G', 'LastName': 'Hettiarachchi', 'Affiliation': 'Medway NHS Foundation Trust, Gillingham, United Kingdom.'}, {'ForeName': 'Biswajit', 'Initials': 'B', 'LastName': 'Chakrabarti', 'Affiliation': 'Aintree University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Ajikumar', 'Initials': 'A', 'LastName': 'Kavidasan', 'Affiliation': 'Milton Keynes University Hospital, Milton Keynes, United Kingdom.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Sutton', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Zahan-Evans', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Jack L', 'Initials': 'JL', 'LastName': 'Quaddy', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Edey', 'Affiliation': 'North Bristol Lung Centre, North Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Amelia O', 'Initials': 'AO', 'LastName': 'Clive', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Walker', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Matthew H R', 'Initials': 'MHR', 'LastName': 'Little', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Xue W', 'Initials': 'XW', 'LastName': 'Mei', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harvey', 'Affiliation': 'North Bristol Lung Centre, North Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Hooper', 'Affiliation': 'Worcester Acute Hospitals NHS Trust, Worcester, United Kingdom.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Davies', 'Affiliation': 'Cardiff and Vale University Health Board, Wales, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Slade', 'Affiliation': 'Department of Respiratory Medicine, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, United Kingdom.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Sivier', 'Affiliation': ''}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}]",JAMA,['10.1001/jama.2019.19997']
814,31155667,Robot Reinforcement and Error-Based Movement Learning in Infants With and Without Cerebral Palsy.,"BACKGROUND
Prone mobility, central to development of diverse psychological and social processes that have lasting effects on life participation, is seldom attained by infants with cerebral palsy (CP) and has no tested interventions. Reinforcement learning (RL) and error-based movement learning (EBL) offer novel intervention possibilities.
OBJECTIVE
This study examined movement learning strategies in infants with or at risk for CP using RL and EBL during acquisition of prone locomotion.
DESIGN
The study was a randomized trial that used repeated measures.
SETTING
The study setting was a university physical therapy clinic in the United States.
PATIENTS
Thirty infants aged 4.5 to 6.5 months participated in the study: 24 had or were at risk for CP, and 6 were typically developing.
INTERVENTION
Infants with and at risk for CP were randomly assigned to a combination of RL and EBL (SIPPC-RE), or RL only (SIPPC-R) conditions. Infants with typical development comprised the RL-only reference group (SIPPC-TD). Infants trained in prone locomotion with the Self-Initiated Prone Progression Crawler (SIPPC) robotic system for three 5-minute trials, twice a week for 12 weeks in their homes or child care. All training sessions were videotaped for behavioral coding.
MEASUREMENTS
The SIPPC gathered robot and infant trunk/limb movement data. Randomized 2-way analysis of variance with repeated measures and Pearson r to analyze the data was used.
RESULTS
Results included the number of arm movements and trial-and-error activity distinguished between the SIPPC-RE and SIPPC-R groups. The mean change in arm movements from baseline for the SIPPC-RE and SIPPC-R groups was 4.8 m and -7.0 m, respectively. The mean differences in rotational amplitude (trial and error) from baseline to the end of the study were 278 degrees and 501 degrees, respectively. These changes were correlated with distance traveled and goal-directed movements. The latter increased over the 12 weeks for the SIPPC-RE and SIPPC-TD groups, but not the SIPPC-R group.
LIMITATIONS
The CP groups were unequal due to reassignment and did not include a typically developing comparison group of a combination of RL and EBL.
CONCLUSION
These findings suggest movement learning and retention in infants with CP is differentially affected by the use of RL and EBL, with a combination of both showing more promise than RL alone. The findings also implicate cognition, type of brain insult, emergence of reaching, and muscle force production, which must be explored in future studies.",2019,"Infants trained in prone locomotion with the Self-Initiated Prone Progression Crawler (SIPPC) robotic system for three 5-minute trials, twice a week for 12 weeks in their homes or child care.","['infants with or at risk for CP using RL and EBL during acquisition of prone locomotion', 'Thirty infants aged 4.5 to 6.5 months participated in the study: 24 had or were at risk for CP, and 6 were typically developing', 'The study setting was a university physical therapy clinic in the United States', 'infants with CP', 'infants with cerebral palsy (CP', 'Infants With and Without Cerebral Palsy']","['Reinforcement learning (RL) and error-based movement learning (EBL', 'combination of RL and EBL (SIPPC-RE), or RL only (SIPPC-R) conditions', 'Robot Reinforcement and Error-Based Movement Learning', 'Self-Initiated Prone Progression Crawler (SIPPC) robotic system']",['number of arm movements and trial-and-error activity'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",30.0,0.0268537,"Infants trained in prone locomotion with the Self-Initiated Prone Progression Crawler (SIPPC) robotic system for three 5-minute trials, twice a week for 12 weeks in their homes or child care.","[{'ForeName': 'Thubi H A', 'Initials': 'THA', 'LastName': 'Kolobe', 'Affiliation': 'Rehabilitation Science, University of Oklahoma Health Sciences Center, 801 NE 13th St, Oklahoma City, OK 73104 (USA).'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Fagg', 'Affiliation': 'Computer Science, University of Oklahoma, Norman, Oklahoma.'}]",Physical therapy,['10.1093/ptj/pzz043']
815,31158087,"Addition of Docetaxel to First-line Long-term Hormone Therapy in Prostate Cancer (STAMPEDE): Modelling to Estimate Long-term Survival, Quality-adjusted Survival, and Cost-effectiveness.","BACKGROUND
Results from large randomised controlled trials have shown that adding docetaxel to the standard of care (SOC) for men initiating hormone therapy for prostate cancer (PC) prolongs survival for those with metastatic disease and prolongs failure-free survival for those without. To date there has been no formal assessment of whether funding docetaxel in this setting represents an appropriate use of UK National Health Service (NHS) resources.
OBJECTIVE
To assess whether administering docetaxel to men with PC starting long-term hormone therapy is cost-effective in a UK setting.
DESIGN, SETTING, AND PARTICIPANTS
We modelled health outcomes and costs in the UK NHS using data collected within the STAMPEDE trial, which enrolled men with high-risk, locally advanced metastatic or recurrent PC starting first-line hormone therapy.
INTERVENTION
SOC was hormone therapy for ≥2 yr and radiotherapy in some patients. Docetaxel (75mg/m 2 ) was administered alongside SOC for six three-weekly cycles.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs).
RESULTS AND LIMITATIONS
The model predicted that docetaxel would extend survival (discounted quality-adjusted survival) by 0.89 yr (0.51) for metastatic PC and 0.78 yr (0.39) for nonmetastatic PC, and would be cost-effective in metastatic PC (ICER £5514/QALY vs SOC) and nonmetastatic PC (higher QALYs, lower costs vs SOC). Docetaxel remained cost-effective in nonmetastatic PC when the assumption of no survival advantage was modelled.
CONCLUSIONS
Docetaxel is cost-effective among patients with nonmetastatic and metastatic PC in a UK setting. Clinicians should consider whether the evidence is now sufficiently compelling to support docetaxel use in patients with nonmetastatic PC, as the opportunity to offer docetaxel at hormone therapy initiation will be missed for some patients by the time more mature survival data are available.
PATIENT SUMMARY
Starting docetaxel chemotherapy alongside hormone therapy represents a good use of UK National Health Service resources for patients with prostate cancer that is high risk or has spread to other parts of the body.",2018,"The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs).
","['enrolled men with high-risk, locally advanced metastatic or recurrent PC starting first-line hormone therapy', 'men with PC starting long-term', 'patients with prostate cancer', 'patients with nonmetastatic PC', 'patients with nonmetastatic and metastatic PC in a UK setting']","['docetaxel', 'Docetaxel to First-line Long-term Hormone Therapy', 'hormone therapy', 'Docetaxel', 'docetaxel chemotherapy alongside hormone therapy', 'SOC was hormone therapy for ≥2 yr and radiotherapy']","['survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'survival (discounted quality-adjusted survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0857722,"The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs).
","[{'ForeName': 'Beth S', 'Initials': 'BS', 'LastName': 'Woods', 'Affiliation': 'Centre for Health Economics, University of York, York, UK. Electronic address: beth.woods@york.ac.uk.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Sideris', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Gannon', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Mymoona', 'Initials': 'M', 'LastName': 'Alzouebi', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'The Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Birtle', 'Affiliation': 'Rosemere Cancer Centre, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Brock', 'Affiliation': 'Dorset Cancer Centre, Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cathomas', 'Affiliation': 'Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland; Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Prabir R', 'Initials': 'PR', 'LastName': 'Chakraborti', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'Gloucestershire Oncology Centre, Cheltenham, UK.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Cross', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'The Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Gale', 'Affiliation': 'Portsmouth Oncology Centre, Queen Alexandra Hospital, Portsmouth, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gibbs', 'Affiliation': 'Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Graham', 'Affiliation': 'Beacon Centre, Musgrove Park Hospital, Taunton, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hughes', 'Affiliation': 'Mount Vernon Group, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Laing', 'Affiliation': ""St Luke's Cancer Centre, Royal Surrey NHS Trust, Guildford, UK.""}, {'ForeName': 'Malcolm D', 'Initials': 'MD', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Matheson', 'Affiliation': 'University of Wolverhampton, Wolverhampton, UK.'}, {'ForeName': 'Duncan B', 'Initials': 'DB', 'LastName': 'McLaren', 'Affiliation': 'Department of Oncology, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Millman', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Joe M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University, Belfast, UK.""}, {'ForeName': 'Omi', 'Initials': 'O', 'LastName': 'Parikh', 'Affiliation': 'Department of Oncology, East Lancashire Hospitals NHS Trust, Burnley, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Peedell', 'Affiliation': 'South Tees NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Protheroe', 'Affiliation': 'Department of Oncology, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Alastair W S', 'Initials': 'AWS', 'LastName': 'Ritchie', 'Affiliation': 'Gloucestershire Royal Hospital Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Sussex Cancer Centre, Royal Sussex County Hospital, Brighton, UK.'}, {'ForeName': 'J Martin', 'Initials': 'JM', 'LastName': 'Russell', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK; Forth Valley Royal Hospital, Larbert, UK.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Simms', 'Affiliation': 'Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Narayanan N', 'Initials': 'NN', 'LastName': 'Srihari', 'Affiliation': 'Shrewsbury and Telford Hospitals NHS Trust, Shrewsbury, UK.'}, {'ForeName': 'Rajaguru', 'Initials': 'R', 'LastName': 'Srinivasan', 'Affiliation': 'Royal Devon & Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Staffurth', 'Affiliation': 'Velindre Cancer Centre, Cardiff and School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Santhanam', 'Initials': 'S', 'LastName': 'Sundar', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'George N', 'Initials': 'GN', 'LastName': 'Thalmann', 'Affiliation': 'Department of Urology, University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Tolan', 'Affiliation': 'Clatterbridge Cancer Centre, Birkenhead, UK.'}, {'ForeName': 'Anna T H', 'Initials': 'ATH', 'LastName': 'Tran', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tsang', 'Affiliation': 'Southend and Basildon Hospitals, Southend, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'Swansea University College of Medicine, Swansea, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Queen Elizabeth Hospital, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sculpher', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}]",European urology oncology,['10.1016/j.euo.2018.06.004']
816,30994898,Effect of a Quality of Care Improvement Initiative in Patients With Acute Coronary Syndrome in Resource-Constrained Hospitals in China: A Randomized Clinical Trial.,"Importance
Prior observational studies suggest that quality of care improvement (QCI) initiatives can improve the clinical outcomes of acute coronary syndrome (ACS). To our knowledge, this has never been demonstrated in a well-powered randomized clinical trial.
Objective
To determine whether a clinical pathway-based, multifaceted QCI intervention could improve clinical outcomes among patients with ACS in resource-constrained hospitals in China.
Design, Setting, Participants
This large, stepped-wedge cluster randomized clinical trial was conducted in nonpercutaneous coronary intervention hospitals across China and included all patients older than 18 years and with a final diagnosis of ACS who were recruited consecutively between October 2011 and December 2014. We excluded patients who died before or within 10 minutes of hospital arrival. We recruited 5768 and 0 eligible patients for the control and intervention groups, respectively, in step 1, 4326 and 1365 in step 2, 3278 and 3059 in step 3, 1419 and 4468 in step 4, and 0 and 5645 in step 5.
Interventions
The intervention included establishing a QCI team, training clinical staff, implementing ACS clinical pathways, sequential site performance assessment and feedback, online technical support, and patient education. The usual care was the control that was compared.
Main Outcomes and Measures
The primary outcome was the incidence of in-hospital major adverse cardiovascular events (MACE), comprising all-cause mortality, reinfarction/myocardial infarction, and nonfatal stroke. Secondary outcomes included 16 key performance indicators (KPIs) and the composite score developed from these KPIs.
Results
Of 29 346 patients (17 639 men [61%]; mean [SD] age for control, 64.1 [11.6] years; mean [SD] age for intervention, 63.9 [11.7] years) who were recruited from 101 hospitals, 14 809 (50.5%) were in the control period and 14 537 (49.5%) were in the intervention period. There was no significant difference in the incidence of in-hospital MACE between the intervention and control periods after adjusting for cluster and time effects (3.9% vs 4.4%; odds ratio, 0.93; 95% CI, 0.75-1.15; P = .52). The intervention showed a significant improvement in the composite KPI score (mean [SD], 0.69 [0.22] vs 0.61 [0.23]; P < .01) and in 7 individual KPIs, including the early use of antiplatelet therapy and the use of appropriate secondary prevention medicines at discharge. No unexpected adverse events were reported.
Conclusions and Relevance
Among resource-constrained Chinese hospitals, introducing a multifaceted QCI intervention had no significant effect on in-hospital MACE, although it improved a few of the care process indicators of evidence-based ACS management.
Trial Registration
ClinicalTrials.gov identifier: NCT01398228.",2019,"The intervention showed a significant improvement in the composite KPI score (mean [SD], 0.69 [0.22] vs 0.61 [0.23]; P < .01) and in 7 individual KPIs, including the early use of antiplatelet therapy and the use of appropriate secondary prevention medicines at discharge.","['mean [SD] age for control, 64.1 [11.6] years; mean', 'nonpercutaneous coronary intervention hospitals across China and included all patients older than 18 years and with a final diagnosis of ACS who were recruited consecutively between October 2011 and December 2014', 'patients who died before or within 10 minutes of hospital arrival', 'We recruited 5768 and 0 eligible patients for the control and intervention groups, respectively, in step 1, 4326 and 1365 in step 2, 3278 and 3059 in step 3, 1419 and 4468 in step 4, and 0 and 5645 in step 5', 'patients with ACS in resource-constrained hospitals in China', 'Patients With Acute Coronary Syndrome in Resource-Constrained Hospitals in China', 'SD] age for intervention, 63.9 [11.7] years) who were recruited from 101 hospitals, 14\u202f809 (50.5%) were in the control period and 14\u202f537 (49.5%) were in the intervention period', 'Results\n\n\nOf 29\u202f346 patients (17\u202f639 men [61', 'acute coronary syndrome (ACS', 'Participants']","['multifaceted QCI intervention', 'Quality of Care Improvement Initiative']","['incidence of in-hospital MACE', 'incidence of in-hospital major adverse cardiovascular events (MACE), comprising all-cause mortality, reinfarction/myocardial infarction, and nonfatal stroke', 'adverse events', 'composite KPI score', '16 key performance indicators (KPIs) and the composite score developed from these KPIs']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301776', 'cui_str': 'Step 1'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",29346.0,0.142285,"The intervention showed a significant improvement in the composite KPI score (mean [SD], 0.69 [0.22] vs 0.61 [0.23]; P < .01) and in 7 individual KPIs, including the early use of antiplatelet therapy and the use of appropriate secondary prevention medicines at discharge.","[{'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Shenshen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'George Institute for Global Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Lingzhi', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Chinese Prevention Medical Association, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Dayi', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Kalipso', 'Initials': 'K', 'LastName': 'Chalkidou', 'Affiliation': 'Global Health and Development, Imperial College, London, United Kingdom.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Cardiovascular Institute and Fuwai Hospital, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.0897']
817,30606884,Impact of Metformin Use and Diabetic Status During Adjuvant Fluoropyrimidine-Oxaliplatin Chemotherapy on the Outcome of Patients with Resected Colon Cancer: A TOSCA Study Subanalysis.,"BACKGROUND
Type 2 diabetes mellitus (T2DM) is associated with increased risk of colon cancer (CC), whereas metformin use seems to be protective. However, the impact of metformin use on the risk of death or disease recurrence after radical surgery for CC remains uncertain.
MATERIALS AND METHODS
This is a substudy conducted in patients with high-risk stage II or stage III CC randomized in the TOSCA trial, which compared 3 versus 6 months of fluoropyrimidine-oxaliplatin adjuvant chemotherapy. Objective of the study was to investigate the impact of metformin exposure during adjuvant chemotherapy on overall survival (OS) and relapse-free survival (RFS). We also evaluated the impact of T2DM or metformin dosage on clinical outcomes.
RESULTS
Out of 3,759 patients enrolled in the TOSCA trial, 133 patients with diabetes (9.2%) and 1,319 without diabetes (90.8%) were recruited in this study. After excluding 13 patients with diabetes without information on metformin exposure, 76 patients with T2DM (63.3%) were defined as metformin users and 44 (36.7%) as metformin nonusers. After a median follow-up of 60.4 months, 26 (21.7%) patients relapsed and 16 (13.3%) died. Metformin use was neither associated with OS (adjusted hazard ratio [HR], 1.51; 95% confidence interval [CI], 0.48-4.77; p = .4781) nor with RFS (HR, 1.56; 95% CI, 0.69-3.54; p = .2881). Similarly, we found no association between T2DM or metformin dosage and OS or RFS.
CONCLUSIONS
Metformin use and T2DM did not impact on OS or RFS in patients with resected CC treated with adjuvant fluoropyrimidine-oxaliplatin chemotherapy. Larger studies and longer follow-up are required to clarify the potential efficacy of metformin in improving the prognosis of patients with CC.
IMPLICATIONS FOR PRACTICE
The role of the antidiabetic drug metformin in colon cancer prevention and treatment is highly debated. While low-dose metformin reduced the incidence of colorectal adenomas in two prospective studies, its effect in patients with already established colon cancer remains unclear. In this study, the potential impact of metformin on the survival of resected colon cancer patients who received adjuvant chemotherapy was investigated in the context of the TOSCA study. We did not find any association between metformin use or dosages and patient survival. Prospective studies are required to draw definitive conclusions about metformin impact on colon cancer recurrence and survival.",2019,"Metformin use was neither associated with OS (adjusted hazard ratio [HR], 1.51; 95% confidence interval [CI], 0.48-4.77; p = .4781) nor with RFS (HR, 1.56; 95% CI, 0.69-3.54; p = .2881).","['patients with already established colon cancer', '3,759 patients enrolled in the TOSCA trial, 133 patients with diabetes (9.2%) and 1,319 without diabetes (90.8%) were recruited in this study', '13 patients with diabetes without information on metformin exposure, 76 patients with T2DM (63.3%) were defined as metformin users and 44 (36.7%) as metformin nonusers', 'Type 2 diabetes mellitus (T2DM', 'patients with resected CC treated with adjuvant', 'resected colon cancer patients who received', 'patients with high-risk stage II or stage III CC randomized in the', 'Patients with Resected Colon Cancer']","['metformin', 'adjuvant chemotherapy', 'fluoropyrimidine-oxaliplatin chemotherapy', 'Fluoropyrimidine-Oxaliplatin Chemotherapy', 'TOSCA', 'T2DM or metformin', 'Metformin', 'antidiabetic drug metformin', 'fluoropyrimidine-oxaliplatin adjuvant chemotherapy']","['Diabetic Status', 'colon cancer recurrence and survival', 'OS or RFS', 'risk of death or disease recurrence', 'T2DM or metformin dosage and OS or RFS', 'incidence of colorectal adenomas', 'overall survival (OS) and relapse-free survival (RFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",133.0,0.0500985,"Metformin use was neither associated with OS (adjusted hazard ratio [HR], 1.51; 95% confidence interval [CI], 0.48-4.77; p = .4781) nor with RFS (HR, 1.56; 95% CI, 0.69-3.54; p = .2881).","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vernieri', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy claudio.vernieri@istitutotumori.mi.it maria.dibartolomeo@istitutotumori.mi.it.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ferrari', 'Affiliation': 'Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': ""Sant'Andrea Hospital, Sapienza University of Rome and IRCCS Istituto Dermopatico dell'Immacolata, Rome, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'IRCCS Istituto Oncologico Veneto, Padua, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Rosario V', 'Initials': 'RV', 'LastName': 'Iaffaioli', 'Affiliation': 'IRCCS Istituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Zampino', 'Affiliation': 'IRCCS Istituto Europeo di Oncologia, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'De Placido', 'Affiliation': 'Università Federico II, Naples, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'IRCCS Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Damiani', 'Affiliation': 'IRCCS San Martino-IST, Genoa, Italy.'}, {'ForeName': 'Daris', 'Initials': 'D', 'LastName': 'Ferrari', 'Affiliation': 'Azienda Ospedaliera San Paolo, Milan, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Ospedale San Carlo, Potenza, Italy.'}, {'ForeName': 'Roberto F', 'Initials': 'RF', 'LastName': 'Labianca', 'Affiliation': 'ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bidoli', 'Affiliation': 'Ospedale San Gerardo dei Tintori, Monza, Italy.'}, {'ForeName': 'Giovanni L', 'Initials': 'GL', 'LastName': 'Frassineti', 'Affiliation': 'IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Nicolini', 'Affiliation': 'Azienda USL Romagna, Cattolica, Rimini, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Pavesi', 'Affiliation': 'Fondazione Salvatore Maugeri, Pavia, Italy.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Tronconi', 'Affiliation': 'Humanitas Clinical and Research Center, Rozzano, Milan, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Buonadonna', 'Affiliation': 'Centro di Riferimento Oncologico, Aviano, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Ferrario', 'Affiliation': 'ASST Fatebenefratelli-Ospedale Luigi Sacco, Milan, Italy.'}, {'ForeName': 'Giovanni Lo', 'Initials': 'GL', 'LastName': 'Re', 'Affiliation': 'Azienda Ospedaliera S. Maria degli Angeli Pordenone, Pordenone, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Adamo', 'Affiliation': 'Dipartimento Universitario di Patologia Umana & Azienda Ospedaliera Papardo, Messina, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Tamburini', 'Affiliation': 'Ospedale degli Infermi, Rimini, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Clerico', 'Affiliation': 'Ospedale degli Infermi, Biella, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giordani', 'Affiliation': 'Ospedale San Salvatore, Pesaro, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Leonardi', 'Affiliation': 'Azienda Ospedaliera Universitaria di Parma, Parma, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Barni', 'Affiliation': 'Ospedale Treviglio Caravaggio Treviglio, Bergamo, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ciarlo', 'Affiliation': 'USL4 Prato, Prato, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Ospedale G. Da Saliceto, Piacenza, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Gori', 'Affiliation': 'Ospedale Sacro Cuore Don Calabria, Verona, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Presidio Ospedaliero Antonio Perrino, Brindisi, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Faedi', 'Affiliation': 'Presidio Ospedaliero Bufalini, Cesena, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Aglietta', 'Affiliation': 'Istituto di Candiolo IRCC, Candiolo Torin, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Antista', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Katia F', 'Initials': 'KF', 'LastName': 'Dotti', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy claudio.vernieri@istitutotumori.mi.it maria.dibartolomeo@istitutotumori.mi.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2018-0442']
818,30615299,The Efficacy of a Lateral Wedge Insole for Painful Medial Knee Osteoarthritis After Prescreening: A Randomized Clinical Trial.,"OBJECTIVE
Lateral wedge shoe insoles decrease medial knee loading, but trials have shown no effect on pain in medial knee osteoarthritis (OA). However, loading effects of insoles are inconsistent, and they can increase patellofemoral loading. We undertook this study to investigate the hypothesis that insoles would reduce pain in preselected patients.
METHODS
Among patients with painful medial knee OA, we excluded those with patellofemoral OA and those with a pain rating of <4 of a possible 10. We further excluded participants who, in a gait analysis using lateral wedges, did not show at least a 2% reduction in knee adduction moment (KAM), compared to wearing their shoes and a neutral insole. We then randomized subjects to lateral wedge versus neutral insole for 8-week periods, separated by an 8-week washout. The primary outcome measure was knee pain (0-10 scale) during the past week, and secondary outcome measures included activity pain and pain rated in the Knee Injury and Osteoarthritis Outcome Score questionnaire. We carried out mixed model analyses adjusted for baseline pain.
RESULTS
Of 83 participants, 21 (25.3%) were excluded from analysis because of insufficient reduction in KAM. In the 62 patients included in analysis, the mean ± SD age was 64.2 ± 9.1 years, and 37.1% were women. Lateral wedge insoles produced a greater reduction in knee pain than neutral insoles (mean difference of 0.7 on 0-10 scale [95% confidence interval 0.1, 1.2]) (P = 0.02). Findings for secondary outcome measures were mixed.
CONCLUSION
In participants prescreened to eliminate those with patellofemoral OA and biomechanical nonresponders, lateral wedge insoles reduced knee pain, but the effect of treatment was small and is likely of clinical significance in only a minority of patients. Targeting patients may identify those who respond to this treatment.",2019,"Lateral wedge insoles produced a greater reduction in knee pain than neutral insoles (mean difference of 0.7 on 0-10 scale [95% confidence interval 0.1, 1.2])","['62 patients included in analysis, the mean ± SD age was 64.2 ± 9.1 years, and 37.1% were women', 'preselected patients', 'Painful Medial Knee Osteoarthritis', 'medial knee osteoarthritis (OA', 'patients with painful medial knee OA']",['Lateral Wedge Insole'],"['knee pain', 'pain', 'knee pain (0-10 scale', 'patellofemoral loading', 'knee adduction moment (KAM', 'activity pain and pain rated in the Knee Injury and Osteoarthritis Outcome Score questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C3873740', 'cui_str': 'Insole'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.294071,"Lateral wedge insoles produced a greater reduction in knee pain than neutral insoles (mean difference of 0.7 on 0-10 scale [95% confidence interval 0.1, 1.2])","[{'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts, and University of Manchester, NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Parkes', 'Affiliation': 'University of Manchester, NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Carter', 'Affiliation': 'University of Manchester, NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anmin', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'University of Salford, Salford, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Callaghan', 'Affiliation': 'University of Manchester, NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, and Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hodgson', 'Affiliation': 'University of Manchester, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bowes', 'Affiliation': 'Imorphics, Ltd., Manchester, UK.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Jones', 'Affiliation': 'University of Salford, Salford, UK.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.40808']
819,31095263,Clinical Performance Evaluation of a Personal Sound Amplification Product vs a Basic Hearing Aid and a Premium Hearing Aid.,"Importance
Hearing loss is a highly prevalent condition with multiple negative associated outcomes, yet few persons with hearing loss have hearing aids (HAs). Personal sound amplification products (PSAPs) could be an alternative low-cost solution to HAs, but data are lacking on the performance of PSAPs.
Objective
To evaluate the clinical efficacy of a PSAP by comparing its performance with that of a basic HA and a premium HA in participants with mild, moderate, and moderately severe hearing impairment.
Design, Setting, and Participants
A prospective, single-institution cohort study was performed with a total of 56 participants, including 19 with mild hearing loss, 20 with moderate hearing loss, and 17 with moderately severe hearing loss. All participants underwent 4 clinical hearing tests with each of the PSAP, basic HA, and premium HA, and all completed an evaluative questionnaire.
Interventions
All hearing devices (PSAP, basic HA, and premium HA) were applied by a clinician to prevent bias and order effects; participants were blinded to the device in use, and sequence of devices was randomized.
Main Outcomes and Measures
The study used the Korean version of the hearing in noise test, the speech intelligibility in noise test, listening effort measurement using a dual-task paradigm, pupillometry, and a self-rating questionnaire regarding sound quality and preference. These tests were administered under the following 4 hearing conditions: unaided hearing, use of PSAP, use of basic HA, and use of premium HA.
Results
The study included 56 participants with a mean age of 56 years (interquartile range, 48-59 years); 29 (52%) were women. In the mild and moderate hearing loss groups, there was no meaningful difference between PSAP, basic HA, and premium HA for speech perception (Cohen d = 0.06-1.05), sound quality (Cohen d = 0.06-0.71), listening effort (Cohen d = 0.10-0.92), and user preference (PSAP, 41%; basic HA, 28%; premium HA, 31%). However, for the patients with moderately severe hearing loss, the premium HA had better performance across most tests (Cohen d = 0.60-1.59), and 70% of participants preferred to use the premium HA.
Conclusions and Relevance
The results indicate that basic and premium HAs were not superior to the PSAP in patients with mild to moderate hearing impairment, which suggests that PSAPs might be used as an alternative to HAs in these patient populations. However, if hearing loss is more severe, then HAs, especially premium HAs, should be considered as an option to manage hearing loss.",2019,"The results indicate that basic and premium HAs were not superior to the PSAP in patients with mild to moderate hearing impairment, which suggests that PSAPs might be used as an alternative to HAs in these patient populations.","['All participants underwent 4 clinical hearing tests with each of the PSAP, basic HA, and premium HA, and all completed an evaluative questionnaire', 'patients with mild to moderate hearing impairment', '56 participants, including 19 with mild hearing loss, 20 with moderate hearing loss, and 17 with moderately severe hearing loss', 'participants with mild, moderate, and moderately severe hearing impairment', '56 participants with a mean age of 56 years (interquartile range, 48-59 years); 29 (52%) were women']","['Personal sound amplification products (PSAPs', 'PSAP', 'Personal Sound Amplification Product vs a Basic Hearing Aid and a Premium Hearing Aid']","['PSAP, basic HA, and premium HA for speech perception', 'sound quality', 'listening effort']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3874334', 'cui_str': 'Severe hearing loss (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}]","[{'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]",56.0,0.0479195,"The results indicate that basic and premium HAs were not superior to the PSAP in patients with mild to moderate hearing impairment, which suggests that PSAPs might be used as an alternative to HAs in these patient populations.","[{'ForeName': 'Young Sang', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Su Yeon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Hearing Research Laboratory, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hye Yoon', 'Initials': 'HY', 'LastName': 'Seol', 'Affiliation': 'Hearing Research Laboratory, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Center for Clinical Epidemiology, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Yang-Sun', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sung Hwa', 'Initials': 'SH', 'LastName': 'Hong', 'Affiliation': 'Hearing Research Laboratory, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Il Joon', 'Initials': 'IJ', 'LastName': 'Moon', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0667']
820,31097078,Manualised cognitive-behavioural therapy in treating depression in advanced cancer: the CanTalk RCT.,"BACKGROUND
With a prevalence of up to 16.5%, depression is one of the commonest mental disorders in people with advanced cancer. Depression reduces the quality of life (QoL) of patients and those close to them. The National Institute for Health and Care Excellence (NICE) guidelines recommend treating depression using antidepressants and/or psychological treatments, such as cognitive-behavioural therapy (CBT). Although CBT has been shown to be effective for people with cancer, it is unclear whether or not this is the case for people with advanced cancer and depression.
OBJECTIVES
To assess the clinical effectiveness and cost-effectiveness of treatment as usual (TAU) plus manualised CBT, delivered by high-level Improving Access to Psychological Therapy (IAPT) practitioners, versus TAU for people with advanced cancer and depression, measured at baseline, 6, 12, 18 and 24 weeks.
DESIGN
Parallel-group, single-blind, randomised trial, stratified by whether or not an antidepressant was prescribed, comparing TAU with CBT plus TAU.
SETTING
Recruitment took place in oncology, hospice and primary care settings. CBT was delivered in IAPT centres or/and over the telephone.
PARTICIPANTS
Patients ( N = 230; n = 115 in each arm) with advanced cancer and depression. Inclusion criteria were a diagnosis of cancer not amenable to cure, a DSM-IV ( Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition) diagnosis of depressive disorder using the Mini-International Neuropsychiatric Interview, a sufficient understanding of English and eligibility for treatment in an IAPT centre. Exclusion criteria were an estimated survival of < 4 months, being at high risk of suicide and receiving, or having received in the last 2 months, a psychological intervention recommended by NICE for treating depression.
INTERVENTIONS
(1) Up to 12 sessions of manualised individual CBT plus TAU delivered within 16 weeks and (2) TAU.
OUTCOME MEASURES
The primary outcome was the Beck Depression Inventory, version 2 (BDI-II) score at 6, 12, 18 and 24 weeks. Secondary outcomes included scores on the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, satisfaction with care, EuroQol-5 Dimensions and the Client Services Receipt Inventory, at 12 and 24 weeks.
RESULTS
A total of 80% of treatments (185/230) were analysed: CBT (plus TAU) ( n = 93) and TAU ( n = 92) for the BDI-II score at all time points using multilevel modelling. CBT was not clinically effective [treatment effect -0.84, 95% confidence interval (CI) -2.76 to 1.08; p = 0.39], nor was there any benefit for other measures. A subgroup analysis of those widowed, divorced or separated showed a significant effect of CBT on the BDI-II (treatment effect -7.21, 95% CI -11.15 to -3.28; p < 0.001). Economic analysis revealed that CBT has higher costs but produces more quality-adjusted life-years (QALYs) than TAU. The mean service costs for participants (not including the costs of the interventions) were similar across the two groups. There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks. There was no statistically significant improvement in QALYs at 24 weeks.
LIMITATIONS
Although all participants satisfied a diagnosis of depression, for some, this was of less than moderate severity at baseline, which could have attenuated treatment effects. Only 64% (74/115) took up CBT, comparable to the general uptake through IAPT.
CONCLUSIONS
Cognitive-behavioural therapy (delivered through IAPT) does not achieve any clinical benefit in advanced cancer patients with depression. The benefit of CBT for people widowed, divorced or separated is consistent with other studies. Alternative treatment options for people with advanced cancer warrant evaluation. Screening and referring those widowed, divorced or separated to IAPT for CBT may be beneficial. Whether or not improvements in this subgroup are due to non-specific therapeutic effects needs investigation.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN07622709.
FUNDING
This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 19. See the NIHR Journals Library website for further project information.",2019,"There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks.","['advanced cancer patients with depression', 'people with cancer', 'Recruitment took place in oncology, hospice and primary care settings', 'people with advanced cancer and depression', '115 in each arm) with advanced cancer and depression', 'people with advanced cancer and depression, measured at baseline, 6, 12, 18 and 24 weeks', 'advanced cancer', 'people with advanced cancer', 'people with advanced cancer warrant evaluation', 'Patients ( N \u2009=\u2009230; n \u2009']","['psychological intervention recommended by NICE', 'CBT', 'usual (TAU) plus manualised CBT, delivered by high-level Improving Access to Psychological Therapy (IAPT) practitioners, versus TAU', 'manualised individual CBT plus TAU', 'CBT (plus TAU', 'Cognitive-behavioural therapy (delivered through IAPT', 'Manualised cognitive-behavioural therapy']","['scores on the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, satisfaction with care, EuroQol-5 Dimensions and the Client Services Receipt Inventory', 'mean service costs', 'EQ-5D median scores', 'clinical effectiveness and cost-effectiveness', 'Beck Depression Inventory, version 2 (BDI-II) score', 'quality of life (QoL']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0303407', 'cui_str': 'In-115 radioisotope'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034380'}]",,0.229638,"There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Serfaty', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Nazareth', 'Affiliation': 'Research Department of Primary Care & Population Health, University College London, London, UK.'}, {'ForeName': 'Stirling', 'Initials': 'S', 'LastName': 'Moorey', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Trefor', 'Initials': 'T', 'LastName': 'Aspden', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tookman', 'Affiliation': 'Marie Curie Hospice, Royal Free Hampstead NHS Trust, London, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mannix', 'Affiliation': 'Palliative Care Service, Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gola', 'Affiliation': 'Research Department of Primary Care & Population Health, University College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Davis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Research Department of Primary Care & Population Health, University College London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23190']
821,31217069,A self-management programme to reduce falls and improve safe mobility in people with secondary progressive MS: the BRiMS feasibility RCT.,"BACKGROUND
Balance, mobility impairments and falls are common problems for people with multiple sclerosis (MS). Our ongoing research has led to the development of Balance Right in MS (BRiMS), a 13-week home- and group-based exercise and education programme intended to improve balance and encourage safer mobility.
OBJECTIVE
This feasibility trial aimed to obtain the necessary data and operational experience to finalise the planning of a future definitive multicentre randomised controlled trial.
DESIGN
Randomised controlled feasibility trial. Participants were block randomised 1 : 1. Researcher-blinded assessments were scheduled at baseline and at 15 and 27 weeks post randomisation. As is appropriate in a feasibility trial, statistical analyses were descriptive rather than involving formal/inferential comparisons. The qualitative elements utilised template analysis as the chosen analytical framework.
SETTING
Four sites across the UK.
PARTICIPANTS
Eligibility criteria included having a diagnosis of secondary progressive MS, an Expanded Disability Status Scale (EDSS) score of between ≥ 4.0 and ≤ 7.0 points and a self-report of two or more falls in the preceding 6 months.
INTERVENTIONS
Intervention - manualised 13-week education and exercise programme (BRiMS) plus usual care. Comparator - usual care alone.
MAIN OUTCOME MEASURES
Trial feasibility, proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls), feasibility of the BRiMS programme (via process evaluation) and economic data.
RESULTS
A total of 56 participants (mean age 59.7 years, standard deviation 9.7 years; 66% female; median EDSS score of 6.0 points, interquartile range 6.0-6.5 points) were recruited in 5 months; 30 were block randomised to the intervention group. The demographic and clinical data were broadly comparable at baseline; however, the intervention group scored worse on the majority of baseline outcome measures. Eleven participants (19.6%) withdrew or were lost to follow-up. Worsening of MS-related symptoms unrelated to the trial was the most common reason ( n = 5) for withdrawal. Potential primary and secondary outcomes and economic data had completion rates of > 98% for all those assessed. However, the overall return rate for the patient-reported falls diary was 62%. After adjusting for baseline score, the differences between the groups (intervention compared with usual care) at week 27 for the potential primary outcomes were MS Walking Scale (12-item) version 2 -7.7 [95% confidence interval (CI) -17.2 to 1.8], MS Impact Scale (29-item) version 2 (MSIS-29vs2) physical 0.6 (95% CI -7.8 to 9) and MSIS-29vs2 psychological -0.4 (95% CI -9.9 to 9) (negative score indicates improvement). After the removal of one outlier, a total of 715 falls were self-reported over the 27-week trial period, with substantial variation between individuals (range 0-93 falls). Of these 715 falls, 101 (14%) were reported as injurious. Qualitative feedback indicated that trial processes and participant burden were acceptable, and participants highlighted physical and behavioural changes that they perceived to result from undertaking BRiMS. Engagement varied, influenced by a range of condition- and context-related factors. Suggestions to improve the utility and accessibility of BRiMS were highlighted.
CONCLUSIONS
The results suggest that the trial procedures are feasible and acceptable, and retention, programme engagement and outcome completion rates were sufficient to satisfy the a priori progression criteria. Challenges were experienced in some areas of data collection, such as completion of daily diaries.
FUTURE WORK
Further development of BRiMS is required to address logistical issues and enhance user-satisfaction and adherence. Following this, a definitive trial to assess the clinical effectiveness and cost-effectiveness of the BRiMS intervention is warranted.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN13587999.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 27. See the NIHR Journals Library website for further project information.",2019,"The results suggest that the trial procedures are feasible and acceptable, and retention, programme engagement and outcome completion rates were sufficient to satisfy the a priori progression criteria.","['56 participants (mean age 59.7 years, standard deviation 9.7 years; 66% female; median EDSS score of 6.0 points, interquartile range 6.0-6.5 points) were recruited in 5 months; 30', 'people with secondary progressive MS', 'Four sites across the UK', 'people with multiple sclerosis (MS', 'Eligibility criteria included having a diagnosis of secondary progressive MS, an Expanded Disability Status Scale (EDSS) score of between ≥\u20094.0 and ≤\u20097.0 points and a self-report of two or more falls in the preceding 6 months']","['Intervention - manualised 13-week education and exercise programme (BRiMS) plus usual care', 'Comparator - usual care alone', 'BRiMS intervention']","['MSIS-29vs2 psychological -0.4', 'safe mobility', 'feasible and acceptable, and retention, programme engagement and outcome completion rates', 'impact of MS, mobility, quality of life and falls), feasibility of the BRiMS programme (via process evaluation) and economic data', 'MS Walking Scale', 'clinical effectiveness and cost-effectiveness', 'utility and accessibility of BRiMS', 'completion rates', 'MS Impact Scale (29-item) version 2 (MSIS-29vs2) physical', 'overall return rate']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0222045'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",715.0,0.122564,"The results suggest that the trial procedures are feasible and acceptable, and retention, programme engagement and outcome completion rates were sufficient to satisfy the a priori progression criteria.","[{'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Gunn', 'Affiliation': 'School of Health Professions, Faculty of Health and Human Sciences, Peninsula Allied Health Centre, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Andrade', 'Affiliation': 'School of Psychology, Faculty of Health and Human Sciences, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Douglas Grant Rehabilitation Unit, Ayrshire Central Hospital, Irvine, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Peninsula Clinical Trials Unit at Plymouth University (PenCTU), Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Stevens', 'Affiliation': 'Medical Statistics Group, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'University of Exeter Medical School, Health Economics Group, University of Exeter, Exeter, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ewings', 'Affiliation': 'National Institute for Health Research (NIHR) Research Design Service (South West), Musgrove Park Hospital, Taunton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'National Institute for Health Research (NIHR) Research Design Service, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Margie', 'Initials': 'M', 'LastName': 'Berrow', 'Affiliation': 'Peninsula Clinical Trials Unit at Plymouth University (PenCTU), Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Vickery', 'Affiliation': 'Peninsula Clinical Trials Unit at Plymouth University (PenCTU), Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Marshall', 'Affiliation': 'Service user representative.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zajicek', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'School of Health Professions, Faculty of Health and Human Sciences, Peninsula Allied Health Centre, University of Plymouth, Plymouth, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23270']
822,31007049,Establishing an electronic health record-supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience.,"AIMS
To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record-supported and conventional recruitment methods.
METHODS
Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record-supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record-supported versus non-electronic health record methods.
RESULTS
In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non-electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record-supported recruitment was adopted by 21 of 22 sites. Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record-supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level.
CONCLUSION
Establishing electronic health record-supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments.",2019,"Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505).","['and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes', 'Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements', '2423 participants were randomized: 1920 from electronic health record (mean age of 60\u2009years, 41% women, 68% White) and 503 from non-electronic health record sources (mean age of 56.9\u2009years, 58% women, 61% White']",['vitamin D'],[],"[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",[],2423.0,0.631977,"Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505).","[{'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': '1 MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Sheehan', 'Affiliation': '3 Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Vickery', 'Affiliation': '3 Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Myrlene A', 'Initials': 'MA', 'LastName': 'Staten', 'Affiliation': '4 KGS for The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': '5 Kaiser Permanente Center for Health Research NW, Portland, OR, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Phillips', 'Affiliation': '6 Atlanta VA Medical Center, Decatur, GA, USA.'}, {'ForeName': 'Irwin G', 'Initials': 'IG', 'LastName': 'Brodsky', 'Affiliation': '8 Maine Medical Center, Scarborough, ME, USA.'}, {'ForeName': 'Chhavi', 'Initials': 'C', 'LastName': 'Chadha', 'Affiliation': '9 HealthPartners, Minneapolis, MN, USA.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Chatterjee', 'Affiliation': '10 Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Miranda G', 'Initials': 'MG', 'LastName': 'Ouellette', 'Affiliation': '11 University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Desouza', 'Affiliation': '13 University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': '3 Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774519839062']
823,31061057,Efficacy of a personalised pelvic floor muscle training programme on urinary incontinence after radical prostatectomy (MaTchUP): protocol for a randomised controlled trial.,"INTRODUCTION
Prostate cancer is the most common cancer in men. Prostatectomy is the most common treatment. Morbidity from prostatectomy is high-80% of men experience urinary incontinence which negatively impacts the quality of life. Postsurgical pelvic floor muscle training is commonly prescribed but recent systematic reviews found no evidence of efficacy. We propose a new treatment that commences preoperatively and targets functional training of specific pelvic floor muscles that contribute to urinary continence. Assessment and biofeedback using transperineal ultrasound imaging assists in training. This will be compared against conventional training (maximal pelvic floor muscle contraction assessed by digital rectal examination) and no training. Embedded physiological studies will allow the investigation of moderation and mediation of the treatment effect on the outcomes.
METHODS AND ANALYSIS
This randomised clinical trial will include 363 men scheduled to undergo radical prostatectomy for prostate cancer. Participants will be randomised into urethral training, conventional training and no training groups. Clinical data will be collected at baseline (1-2 weeks presurgery) and postsurgery after catheter removal, weekly to 3 months (primary endpoint) and monthly to 12 months. Outcomes include 24-hour pad weight test (primary), incontinence, quality of life and cost-effectiveness data. Neuromuscular control measures of pelvic floor muscles will be measured at baseline, postsurgery, 6 weeks, 3 and 12 months. Study assessors and statisticians will be blinded to the group allocation.
ETHICS AND DISSEMINATION
This study is registered with the Australian New Zealand Clinical Trials Registry and has ethical approval from the university and host hospital ethics committees. Trial outcomes will be shared via national/international conference presentations and peer-reviewed journal publications.
TRIAL REGISTRATION NUMBER
ACTRN12617000788370; Pre-results.",2019,"Neuromuscular control measures of pelvic floor muscles will be measured at baseline, postsurgery, 6 weeks, 3 and 12 months.","['urinary incontinence after radical prostatectomy (MaTchUP', '363 men scheduled to undergo radical prostatectomy for prostate cancer']","['urethral training, conventional training and no training groups', 'personalised pelvic floor muscle training programme']","['quality of life', 'Morbidity', '24-hour pad weight test (primary), incontinence, quality of life and cost-effectiveness data']","[{'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0034380'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",363.0,0.162443,"Neuromuscular control measures of pelvic floor muscles will be measured at baseline, postsurgery, 6 weeks, 3 and 12 months.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hodges', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Stafford', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Geoff D', 'Initials': 'GD', 'LastName': 'Coughlin', 'Affiliation': ""Renal Medicine, Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ashton-Miller', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Anne P', 'Initials': 'AP', 'LastName': 'Cameron', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Connelly', 'Affiliation': 'Centre for the Business and Economics of Health, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Hall', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-028288']
824,30845365,Effect of Alendronic Acid on Fracture Healing: A Multicenter Randomized Placebo-Controlled Trial.,"There is a concern that bisphosphonates may impair fracture healing because of their inhibitory effects on bone turnover. Here we evaluated the effects of early bisphosphonate therapy on fracture healing and functional outcome following a fracture of the distal radius. The fracture and bisphosphonates (FAB) trial was a double-blind, randomized, placebo-controlled trial involving 15 trauma centers in the United Kingdom. We enrolled 421 bisphosphonate-naive patients aged ≥50 years with a radiographically confirmed fracture of the distal radius and randomized them in a 1:1 ratio to receive alendronic acid 70 mg once weekly (n = 215) or placebo (n = 206) within 14 days of the fracture. The primary outcome measure was the proportion of fractures that had radiologically united at 4 weeks as assessed by an observer, blinded to treatment allocation. Secondary outcomes included the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire, range of wrist movement and grip strength, pain and analgesia requirements, and the rate of malunion. The mean ± SD age of participants was 63 ± 8.5 years and 362 (86%) were female. At 4 weeks, 48 of 202 (23.8%) fractures had united in the alendronic acid group compared with 52 of 187 (27.8%) in the placebo group (observed absolute proportion difference 4.0%; 95% CI, -4.7% to 12.8%; p = 0.36). The absolute proportion difference between groups based on imputed data was 4.5% (95% CI, -4.7% to 13.8%; p = 0.30). There was no significant difference in the proportion of fractures that had united at any other time point and no differences in the DASH score, pain at the fracture site, grip strength, or any other clinical outcome. We conclude that among patients aged 50 years and above with a distal radius fracture, early administration of alendronic acid does not adversely affect fracture union or clinical outcome. These findings suggest bisphosphonate therapy can be safely commenced early after fracture if clinically indicated. © 2019 American Society for Bone and Mineral Research.",2019,"At 4 weeks, 48 of 202 (23.8%) fractures had united in the alendronic acid group compared with 52 of 187 (27.8%) in the placebo group (observed absolute proportion difference 4.0%; 95% CI, -4.7% to 12.8%; p = 0.36).","['421 bisphosphonate-naive patients aged ≥50 years with a radiographically confirmed fracture of the distal radius and randomized them in a 1:1 ratio to receive', 'patients aged 50 years and above with a distal radius fracture, early administration of', '15 trauma centers in the United Kingdom', '© 2019 American Society for Bone and Mineral Research', 'The mean\u2009±\u2009SD age of participants was 63\u2009±\u20098.5 years and 362 (86%) were female']","['placebo', 'Placebo', 'alendronic acid 70', 'alendronic acid', 'bisphosphonates', 'Alendronic Acid', 'bisphosphonate therapy']","['DASH score, pain at the fracture site, grip strength, or any other clinical outcome', 'fracture healing and functional outcome', 'proportion of fractures that had radiologically united', 'Fracture Healing', 'proportion of fractures', 'Disabilities of the Arm Shoulder and Hand (DASH) questionnaire, range of wrist movement and grip strength, pain and analgesia requirements, and the rate of malunion']","[{'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0771311', 'cui_str': 'Alendronic acid'}, {'cui': 'C4510264', 'cui_str': 'Disphosphonate therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2919270', 'cui_str': 'Disabilities of the arm, shoulder and hand outcome measurement'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",421.0,0.680244,"At 4 weeks, 48 of 202 (23.8%) fractures had united in the alendronic acid group compared with 52 of 187 (27.8%) in the placebo group (observed absolute proportion difference 4.0%; 95% CI, -4.7% to 12.8%; p = 0.36).","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Duckworth', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'McQueen', 'Affiliation': 'Edinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Tuck', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Tobias', 'Affiliation': 'Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jeremy Mark', 'Initials': 'JM', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Leela C', 'Initials': 'LC', 'LastName': 'Biant', 'Affiliation': 'Trauma & Orthopaedic Surgery, University of Manchester, Manchester, UK.'}, {'ForeName': 'Elizabeth Claire', 'Initials': 'EC', 'LastName': 'Pulford', 'Affiliation': 'Oxford University Hospitals National Health Service (NHS) Foundation Trust, Headington, Oxford, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Aldridge', 'Affiliation': 'The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Edwards', 'Affiliation': 'Norfolk and Norwich University Hospital Foundation Trust, Norwich, UK.'}, {'ForeName': 'Chris P', 'Initials': 'CP', 'LastName': 'Roberts', 'Affiliation': 'Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Ramachandran', 'Affiliation': 'Royal London Hospital, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Andrew Richard', 'Initials': 'AR', 'LastName': 'McAndrew', 'Affiliation': 'Royal Berkshire Hospital Foundation Trust, Reading, UK.'}, {'ForeName': 'Kenneth Ck', 'Initials': 'KC', 'LastName': 'Cheng', 'Affiliation': 'NHS Ayrshire & Arran, Ayr, UK.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Johnston', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Nasir H', 'Initials': 'NH', 'LastName': 'Shah', 'Affiliation': 'Warrington & Halton Hospitals NHS Foundation Trust, Warrington, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mathew', 'Affiliation': ""Queen's Hospital, Romford, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Harvie', 'Affiliation': 'Raigmore Hospital, Inverness, UK.'}, {'ForeName': 'Birgit C', 'Initials': 'BC', 'LastName': 'Hanusch', 'Affiliation': 'South Tees, Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Harkess', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Aryelly', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Murray', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Ralston', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3679']
825,31734069,Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial.,"BACKGROUND
Cryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy.
METHODS
We report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1-5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239.
FINDINGS
Between Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital.
INTERPRETATION
Results from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results.
FUNDING
US National Institutes of Health.",2020,"Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31).","['Between Aug 2, 2017, and Jan 15, 2019', '750 participants', 'recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy', 'patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs']","['Thermal ablation versus cryotherapy or loop excision', 'thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation', 'routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA', 'LLETZ']","['treatment success, defined as either human papillomavirus (HPV) type-specific clearance', 'severe pain', 'complication requiring medical consultation or admission to hospital', 'Treatment success']","[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",750.0,0.164652,"Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31).","[{'ForeName': 'Leeya F', 'Initials': 'LF', 'LastName': 'Pinder', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA; Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Groesbeck P', 'Initials': 'GP', 'LastName': 'Parham', 'Affiliation': 'Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia; Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Basu', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France. Electronic address: basup@iarc.fr.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Muwonge', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Namakau', 'Initials': 'N', 'LastName': 'Nyambe', 'Affiliation': 'UNC Global Project-Zambia, Lusaka, Zambia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sauvaget', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Mulindi H', 'Initials': 'MH', 'LastName': 'Mwanahamuntu', 'Affiliation': 'Department of Obstetrics and Gynecology, Women and Newborn Hospital, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Rengaswamy', 'Initials': 'R', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Research Triangle Institute, International-India, Commercial Tower, Pullman Hotel Aerocity, New Delhi, India.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Prendiville', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30635-7']
826,31399845,Canagliflozin and fracture risk in individuals with type 2 diabetes: results from the CANVAS Program.,"AIMS/HYPOTHESIS
An increased risk of fracture with canagliflozin vs placebo was reported from the CANagliflozin cardioVascular Assessment Study (CANVAS) Program, with heterogeneity of findings identified between the two trials that comprise the CANVAS Program, CANVAS and CANVAS-R. The objective of these analyses was to identify reasons for the possibly different effects on fracture observed between CANVAS and CANVAS-R.
METHODS
This study was an analysis of two highly similar trials, CANVAS and CANVAS-R, conducted in 10,142 individuals with type 2 diabetes and history or high risk of cardiovascular disease who received canagliflozin (pooled 100/300 mg once daily) or placebo. Outcomes assessed in this analysis were effects on adjudicated fractures overall and by type, location, association with a fall, dose and follow-up time.
RESULTS
A total of 496 participants recorded ≥1 fracture event during follow-up (15.40 vs 11.93 per 1000 patient-years with canagliflozin vs placebo; HR 1.26 [95% CI 1.04, 1.52]). There was significant heterogeneity in the effects on fracture (p = 0.005) between CANVAS (n = 4330: HR 1.55 [95% CI 1.21, 1.97]) and CANVAS-R (n = 5812: HR 0.86 [95% CI 0.62, 1.19]). The between-study heterogeneity in fracture risk was not clearly explained by differences in baseline characteristics, interactions of randomised treatment with participant characteristics, dose effects, duration of follow-up, metabolic effects, adverse events related to falls or adverse events possibly causing falls.
CONCLUSIONS/INTERPRETATION
There was no evidence to explain clearly the fracture risk observed in the CANVAS Program or the heterogeneity in fracture risk between the two studies. The recently reported null result for fracture in the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial suggests that the observed association in CANVAS is likely to be a chance finding, although an unidentified fall-related mechanism remains a possibility.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01032629, NCT01989754.",2019,"There was significant heterogeneity in the effects on fracture (p = 0.005) between CANVAS (n = 4330: HR 1.55 [95% CI 1.21, 1.97]) and CANVAS-R (n = 5812: HR 0.86 [95% CI 0.62, 1.19]).","['10,142 individuals with type 2 diabetes and history or high risk of cardiovascular disease who received', 'individuals with type 2 diabetes']","['canagliflozin vs placebo', 'Canagliflozin', 'canagliflozin (pooled 100/300\xa0mg once daily) or placebo']","['adjudicated fractures overall and by type, location, association with a fall, dose and follow-up time', 'risk of fracture', 'fracture risk', 'fracture', 'fracture event']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",496.0,0.268013,"There was significant heterogeneity in the effects on fracture (p = 0.005) between CANVAS (n = 4330: HR 1.55 [95% CI 1.21, 1.97]) and CANVAS-R (n = 5812: HR 0.86 [95% CI 0.62, 1.19]).","[{'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Level 5, 1 King St, Newtown, Sydney, NSW, 2042, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Level 5, 1 King St, Newtown, Sydney, NSW, 2042, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Level 5, 1 King St, Newtown, Sydney, NSW, 2042, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'The Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Oh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Simpson', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Nelson B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Level 5, 1 King St, Newtown, Sydney, NSW, 2042, Australia. bneal@georgeinstitute.org.au.'}]",Diabetologia,['10.1007/s00125-019-4955-5']
827,30866672,Improving pragmatic clinical trial design using real-world data.,"BACKGROUND
Pragmatic clinical trials often use automated data sources such as electronic health records, claims, or registries to identify eligible individuals and collect outcome information. A specific advantage that this automated data collection often yields is having data on potential participants when design decisions are being made. We outline how this data can be used to inform trial design.
METHODS
Our work is motivated by a pragmatic clinical trial evaluating the impact of suicide-prevention outreach interventions on fatal and non-fatal suicide attempts in the 18 months after randomization. We illustrate our recommended approaches for designing pragmatic clinical trials using historical data from the health systems participating in this study. Specifically, we illustrate how electronic health record data can be used to inform the selection of trial eligibility requirements, to estimate the distribution of participant characteristics over the course of the trial, and to conduct power and sample size calculations.
RESULTS
Data from 122,873 people with patient health questionnaire (PHQ) responses, recorded in their electronic health records between 1 July 2010 and 31 March 2012, were used to show that the suicide attempt rate in the 18 months following completion of the questionnaire varies by response to item nine of the PHQ. We estimated that the proportion of individuals with a prior recorded elevated PHQ (i.e. history of suicidal ideation) would decrease from approximately 50% at the beginning of a trial to about 5%, 50 weeks later. Using electronic health record data, we conducted simulations to estimate the power to detect a 25% reduction in suicide attempts. Simulation-based power calculations estimated that randomizing 8000 participants per randomization arm would allow 90% power to detect a 25% reduction in the suicide attempt rate in the intervention arm compared to usual care at an alpha rate of 0.05.
CONCLUSIONS
Historical data can be used to inform the design of pragmatic clinical trials, a strength of trials that use automated data collection for randomizing participants and assessing outcomes. In particular, realistic sample size calculations can be conducted using real-world data from the health systems in which the trial will be conducted. Data-informed trial design should yield more realistic estimates of statistical power and maximize efficiency of trial recruitment.",2019,"We estimated that the proportion of individuals with a prior recorded elevated PHQ (i.e. history of suicidal ideation) would decrease from approximately 50% at the beginning of a trial to about 5%, 50 weeks later.","['122,873 people with patient health questionnaire (PHQ) responses, recorded in their electronic health records between 1 July 2010 and 31 March 2012']",[],['suicide attempt rate'],"[{'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}]",122873.0,0.186265,"We estimated that the proportion of individuals with a prior recorded elevated PHQ (i.e. history of suicidal ideation) would decrease from approximately 50% at the beginning of a trial to about 5%, 50 weeks later.","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Shortreed', 'Affiliation': '1 Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Rutter', 'Affiliation': '3 RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Cook', 'Affiliation': '1 Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': '4 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519833679']
828,30738555,"Lithium for the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Discontinuation Study.","OBJECTIVE
This study examined the role of lithium in the maintenance treatment of pediatric patients with bipolar I disorder (BP-I).
METHOD
Participants aged 7 to 17 years who presented with a manic or mixed episode received 24 weeks of lithium treatment in one of two multiphase studies, the Collaborative Lithium Trials (CoLT 1 and CoLT 2). Responders were randomized to continue lithium or to be cross-titrated to placebo for up to 28 weeks. The primary outcome measure was relative risk of study discontinuation for any reason.
RESULTS
A Cox regression analysis found that those who continued treatment with lithium (n = 17) had a lower hazard ratio compared to those who received placebo (n = 14) (p = .015)]. The vast majority of discontinuations were due to mood symptom exacerbations, with most of these occurring in the placebo-treated group. Discontinuation for other reasons occurred at similarly low rates across both group. Most adverse events were mild to moderate in severity, and only one study participant was discontinued from the trial owing to a serious adverse event (aggression). There was no statistically significant difference with respect to weight gain in participants receiving lithium compared to those receiving placebo.
CONCLUSION
This randomized, double-blind, placebo-controlled Discontinuation Trial builds support for the role of lithium as a maintenance treatment in pediatric patients with bipolar disorder and for the safety and tolerability of 28 weeks of maintenance lithium treatment.
CLINICAL TRIAL REGISTRATION INFORMATION
Lithium for the Treatment of Pediatric Mania; https://clinicaltrials.gov/; NCT00442039 (CoLT 1). Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania; https://clinicaltrials.gov/; NCT01166425 (CoLT 2).",2019,"There was no statistically significant difference with respect to weight gain in participants receiving lithium compared to those receiving placebo.
","['Bipolar I Disorder', 'Participants aged 7 to 17 years who presented with a manic or mixed episode received 24 weeks of lithium treatment in one of two multiphase studies, the Collaborative Lithium Trials (CoLT 1 and CoLT 2', 'pediatric patients with bipolar I disorder (BP-I', 'pediatric patients with bipolar disorder and for the safety and tolerability of 28 weeks of maintenance lithium treatment']","['lithium or to be cross-titrated to placebo', 'lithium', 'placebo', 'Placebo', 'Lithium']","['lower hazard ratio', 'relative risk of study discontinuation for any reason', 'weight gain']","[{'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.46334,"There was no statistically significant difference with respect to weight gain in participants receiving lithium compared to those receiving placebo.
","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'The Johns Hopkins University, Baltimore, MD. Electronic address: RFindli1@jhmi.edu.'}, {'ForeName': 'Nora K', 'Initials': 'NK', 'LastName': 'McNamara', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Pavuluri', 'Affiliation': 'The Brain and Wellness Institute, Chicago, IL.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Frazier', 'Affiliation': 'University of Massachusetts Medical School, Boston.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Rynn', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Scheffer', 'Affiliation': 'private practice.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Kafantaris', 'Affiliation': 'The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY.'}, {'ForeName': 'Adelaide', 'Initials': 'A', 'LastName': 'Robb', 'Affiliation': 'George Washington University School of Medicine & Health Sciences, Washington, DC.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'DelBello', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Kowatch', 'Affiliation': 'Ohio State University Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Brieana M', 'Initials': 'BM', 'LastName': 'Rowles', 'Affiliation': 'The Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Lingler', 'Affiliation': 'The EMMES Corporation, Rockville, MD.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'The EMMES Corporation, Rockville, MD.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Clemons', 'Affiliation': 'The EMMES Corporation, Rockville, MD.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Martz', 'Affiliation': 'The EMMES Corporation, Rockville, MD.'}, {'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Anand', 'Affiliation': 'The EMMES Corporation, Rockville, MD.'}, {'ForeName': 'Perdita', 'Initials': 'P', 'LastName': 'Taylor-Zapata', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.07.901']
829,30738706,Long-term outcomes of stenting and endarterectomy for symptomatic carotid stenosis: a preplanned pooled analysis of individual patient data.,"BACKGROUND
The risk of periprocedural stroke or death is higher after carotid artery stenting (CAS) than carotid endarterectomy (CEA) for the treatment of symptomatic carotid stenosis. However, long-term outcomes have not been sufficiently assessed. We sought to combine individual patient-level data from the four major randomised controlled trials of CAS versus CEA for the treatment of symptomatic carotid stenosis to assess long-term outcomes.
METHODS
We did a pooled analysis of individual patient-level data, acquired from the four largest randomised controlled trials assessing the relative efficacy of CAS and CEA for treatment of symptomatic carotid stenosis (Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy trial, International Carotid Stenting Study, and Carotid Revascularization Endarterectomy versus Stenting Trial). The risk of ipsilateral stroke was assessed between 121 days and 1, 3, 5, 7, 9, and 10 years after randomisation. The primary outcome was the composite risk of stroke or death within 120 days after randomisation (periprocedural risk) or subsequent ipsilateral stroke up to 10 years after randomisation (postprocedural risk). Analyses were intention-to-treat, with the risk of events calculated using Kaplan-Meier methods and Cox proportional hazards analysis with adjustment for trial.
FINDINGS
In the four trials included, 4775 patients were randomly assigned, of whom a total of 4754 (99·6%) patients were followed up for a maximum of 12·4 years. 21 (0·4%) patients immediately withdrew consent after randomisation and were excluded. Median length of follow-up across the studies ranged from 2·0 to 6·9 years. 129 periprocedural and 55 postprocedural outcome events occurred in patients allocated CEA, and 206 and 57 for those allocated CAS. After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS. Nonetheless, the periprocedural and postprocedural risks combined favoured CEA, with treatment differences at 1, 3, 5, 7, and 9 years all ranging between 2·8% (1·1-4·4) and 4·1% (2·0-6·3).
INTERPRETATION
Outcomes in the postprocedural period after CAS and CEA were similar, suggesting robust clinical durability for both treatments. Although long-term outcomes (periprocedural and postprocedural risks combined) continue to favour CEA, the similarity of the postprocedural rates suggest that improvements in the periprocedural safety of CAS could provide similar outcomes of the two procedures in the future.
FUNDING
None.",2019,"After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS.","['4775 patients were randomly assigned, of whom a total of 4754 (99·6%) patients were followed up for a maximum of 12·4 years', 'symptomatic carotid stenosis', 'Patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy trial, International Carotid Stenting Study, and Carotid Revascularization Endarterectomy versus Stenting Trial']","['CAS versus CEA', 'stenting and endarterectomy', 'CAS and CEA', 'carotid endarterectomy (CEA', 'CAS', 'carotid artery stenting (CAS', 'symptomatic carotid stenosis (Endarterectomy versus Angioplasty']","['annual rates of ipsilateral stroke per person-year', 'risk of ipsilateral stroke', 'composite risk of stroke or death within 120 days after randomisation (periprocedural risk) or subsequent ipsilateral stroke', 'Median length']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0007282', 'cui_str': 'Carotid Artery Narrowing'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0411287', 'cui_str': 'Percutaneous transluminal balloon angioplasty (procedure)'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3495793', 'cui_str': 'Carotid revascularisation'}]","[{'cui': 'C0014098', 'cui_str': 'Endarterectomy'}, {'cui': 'C0014099', 'cui_str': 'Carotid Endarterectomy'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0007282', 'cui_str': 'Carotid Artery Narrowing'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",4775.0,0.404534,"After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS.","[{'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Brott', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Calvet', 'Affiliation': 'Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, Paris, France.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Howard', 'Affiliation': 'Department of Biostatistics, UAB School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gregson', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Algra', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Becquemin', 'Affiliation': 'Vascular Institute of Paris East, Hôspital Paul D Egine, Champigny-sur-Marne, France.'}, {'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'de Borst', 'Affiliation': 'Department of Vascular Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bulbulia', 'Affiliation': 'Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hans-Henning', 'Initials': 'HH', 'LastName': 'Eckstein', 'Affiliation': 'Department for Vascular and Endovascular Surgery-Vascular Center, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Fraedrich', 'Affiliation': 'Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Jacoba P', 'Initials': 'JP', 'LastName': 'Greving', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Halliday', 'Affiliation': 'Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Hendrikse', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Jansen', 'Affiliation': 'Clinic for Radiology and Neuroradiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Jenifer H', 'Initials': 'JH', 'LastName': 'Voeks', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': 'Department of Neurology, University of Heidelberg Medical School, Heidelberg, Germany.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Mas', 'Affiliation': 'Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, Paris, France.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Brown', 'Affiliation': 'Stroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, University College London, London, UK. Electronic address: martin.brown@ucl.ac.uk.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Bonati', 'Affiliation': 'Stroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, University College London, London, UK; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30028-6']
830,30665714,Impact of baseline early auditory processing on response to cognitive remediation for schizophrenia.,"BACKGROUND
Early auditory processing (EAP) has increasingly become a focus of efforts to identify biomarkers of treatment response in schizophrenia. EAP deficits lead to poor functional outcome via impaired cognition, and treatments that target EAP may drive downstream cognitive improvements. Assessment of baseline need provides an opportunity for cognitive remediation (CR) programs that give EAP training to personalize treatment and optimize its impact. This initial efficacy study examined the differential benefit of EAP training for those with and without baseline EAP deficits as defined by performance on the Tone Matching Test.
METHODS
103 outpatient adults diagnosed with schizophrenia or schizoaffective disorder were classified as having intact (48.5%) or impaired (51.5%) EAP and randomized to a CR program with restorative exercise plans that either included EAP training (N = 49) or did not (N = 54). Cognitive and functional outcomes were measured post-treatment and 3 months later.
RESULTS
Only in EAP impaired participants was there a significant benefit from EAP training on verbal learning. Treatment condition did not significantly impact global cognitive or functional outcomes for either EAP group. Cognitive gains partially mediated the relationship between gains in EAP and functional capacity.
CONCLUSION
These findings support the importance of addressing basic auditory deficits when attempting to remediate higher order auditory impairments such as verbal learning. In addition, they highlight the need for routine assessment of EAP in cognitive remediation participants, as well as the need for more effective programs to reverse these impairments.",2019,Treatment condition did not significantly impact global cognitive or functional outcomes for either EAP group.,"['103 outpatient adults diagnosed with schizophrenia or schizoaffective disorder were classified as having intact (48.5%) or impaired (51.5%) EAP and randomized to a', 'schizophrenia']","['CR program with restorative exercise plans that either included EAP training (N\u202f=\u202f49) or did not (N\u202f=\u202f54', 'baseline early auditory processing', 'EAP training', 'Early auditory processing (EAP']","['impact global cognitive or functional outcomes', 'Cognitive and functional outcomes', 'verbal learning']","[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}]",103.0,0.0333335,Treatment condition did not significantly impact global cognitive or functional outcomes for either EAP group.,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Medalia', 'Affiliation': 'New York State Psychiatric Institute, Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons and New York Presbyterian, New York, NY 10032, USA. Electronic address: Alice.Medalia@columbia.edu.'}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Saperstein', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY 10032, USA. Electronic address: Alice.Saperstein@nyspi.columbia.edu.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'Columbia University Mailman School of Public Health, Department of Biostatistics, New York, NY 10032, USA. Electronic address: mq2158@cumc.columbia.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'New York State Psychiatric Institute, Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY 10032, USA. Electronic address: dcj2113@cumc.columbia.edu.'}]",Schizophrenia research,['10.1016/j.schres.2019.01.012']
831,32151214,A Randomized Controlled Trial of Video Psychoeducation for Electroconvulsive Therapy in the United States.,"OBJECTIVE
Electroconvulsive therapy (ECT) is a highly effective psychiatric treatment that remains largely underutilized. Patient psychoeducation about ECT may improve uptake of this treatment.
METHODS
This randomized controlled trial compared two forms of psychoeducation about ECT: video psychoeducation and an informational brochure. In 2019, a national sample of 556 U.S. adults who screened positive for depression were recruited and randomly assigned to receive one of these educational interventions online. Participant perceptions, knowledge, and willingness to receive ECT were assessed before and after psychoeducation.
RESULTS
Both the video psychoeducation and brochure groups showed significantly more positive perceptions and knowledge about ECT following the intervention, with no significant differences between groups. The proportion of participants who reported being willing to receive ECT increased significantly after receipt of psychoeducation (from 31% to 63% in the video psychoeducation group and from 29% to 56% in the brochure group). Female gender, severity of depression, and comorbid mental and substance use disorders were associated with positive changes in ECT perceptions and increased willingness to receive ECT.
CONCLUSIONS
These findings suggest brief psychoeducation for ECT is needed and may improve acceptance of this robust treatment.",2020,"Both the video psychoeducation and brochure groups showed significantly more positive perceptions and knowledge about ECT following the intervention, with no significant differences between groups.","['In 2019, a national sample of 556 U.S. adults who screened positive for depression']","['ECT', 'educational interventions online', 'Electroconvulsive therapy (ECT', 'psychoeducation about ECT: video psychoeducation and an informational brochure', 'Video Psychoeducation']","['positive perceptions and knowledge about ECT', 'Participant perceptions, knowledge, and willingness to receive ECT']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]",556.0,0.292575,"Both the video psychoeducation and brochure groups showed significantly more positive perceptions and knowledge about ECT following the intervention, with no significant differences between groups.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}, {'ForeName': 'Minda', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rosenheck', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wilkinson', 'Affiliation': 'National Center on Homelessness Among Veterans, U.S. Department of Veterans Affairs (VA), and the VA Connecticut Healthcare System, West Haven, Connecticut (Tsai, Rosenheck); Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut (Tsai, Rosenheck, Wilkinson); Department of Psychology, University of Hartford, West Hartford, Connecticut (Huang).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900448']
832,31199458,Differential Effects of Oral Boluses of Vitamin D2 vs Vitamin D3 on Vitamin D Metabolism: A Randomized Controlled Trial.,"CONTEXT
Vitamin D2 and vitamin D3 have been hypothesized to exert differential effects on vitamin D metabolism.
OBJECTIVE
To compare the influence of administering vitamin D2 vs vitamin D3 on metabolism of vitamin D3.
METHODS
We measured baseline and 4-month serum concentrations of vitamin D3, 25-hydroxyvitamin D3 [25(OH)D3], 25-hydroxyvitamin D2, 24R,25-dihydroxyvitamin D3 [24R,25(OH)2D3], 1α,25-dihydroxyvitamin D3 [1α,25(OH)2D3], and 4β,25-dihydroxyvitamin D3 [4β,25(OH)2D3] in 52 adults randomized to receive a total of four oral bolus doses of 2.5 mg vitamin D2 (n = 28) or vitamin D3 (n = 24) over four months. Metabolite-to-parent compound ratios were calculated to estimate hydroxylase activity. Pairwise before vs after comparisons were made to evaluate effects of vitamin D2 and vitamin D3 on metabolism of vitamin D. Mean postsupplementation metabolite-to-parent ratios were then compared between groups.
RESULTS
Vitamin D2 was less effective than vitamin D3 in elevating total serum 25(OH)D concentration. Vitamin D2 suppressed mean four-month serum concentrations of 25(OH)D3, 24R,25(OH)2D3, 1α,25(OH)2D3, and 4β,25(OH)2D3 and mean ratios of 25(OH)D3 to D3 and 1α,25(OH)2D3 to 25(OH)D3, while increasing the mean ratio of 24R,25(OH)2D3 to 25(OH)D3. Vitamin D3 increased mean four-month serum concentrations of 25(OH)D3, 24R,25(OH)2D3, 1α,25(OH)2D3, and 4β,25(OH)2D3 and the mean ratio of 24R,25(OH)2D3 to 25(OH)D3. Participants receiving vitamin D2 had lower mean postsupplementation ratios of 25(OH)D3 to vitamin D3 and 1α,25(OH)2D3 to 25(OH)D3 than those receiving vitamin D3. Mean postsupplementation ratios of 24R,25(OH)2D3 to 25(OH)D3 and 4β,25(OH)2D3 to 25(OH)D3 did not differ between groups.
CONCLUSIONS
Bolus-dose vitamin D2 is less effective than bolus-dose vitamin D3 in elevating total serum 25(OH)D concentration. Administration of vitamin D2 reduces 25-hydroxylation of vitamin D3 and 1-α hydroxylation of 25(OH)D3, while increasing 24R-hydroxylation of 25(OH)D3.",2019,"Participants receiving vitamin D2 had lower mean post-supplementation ratios of 25(OH)D3-to-vitamin D3 and 1α,25(OH)2D3-to-25(OH)D3 than those receiving vitamin D3.",['52 adults'],"['vitamin D2', 'vitamin D2 versus vitamin D3', 'vitamin D2 and vitamin D3', 'Vitamin D2 and vitamin D3', 'vitamin D2 (n=28) or vitamin D3', 'vitamin D2 vs vitamin D3', 'Vitamin D3', 'vitamin D3']","['vitamin D metabolism', 'total serum 25(OH)D concentration', 'vitamin D3 and 1-alpha hydroxylation of 25(OH)D3', 'mean ratio of 24R,25(OH)2D3-to-25(OH)D3', 'mean post-supplementation ratios of 25(OH)D3-to-vitamin D3 and 1α,25(OH)2D3-to-25(OH)D3', 'mean 4-month serum concentrations of 25(OH)D3, 24R,25(OH)2D3, 1α,25(OH)2D3 and 4β,25(OH)2D3, and the mean ratio of 24R,25(OH)2D3-to-25(OH)D3', 'Mean post-supplementation ratios of 24R,25(OH)2D3-to-25(OH)D3 and 4β,25(OH)2D3-to-25(OH)D3', 'serum concentrations of vitamin D3, 25-hydroxyvitamin D3 (25[OH]D3), 25-hydroxyvitamin D2, 24R,25-dihydroxyvitamin D3 (24R,25[OH]2D3), 1α,25-dihydroxyvitamin D3 (1α,25[OH]2D3) and 4β,25-dihydroxyvitamin D3 (4β,25[OH]2D3', 'Vitamin D2 suppressed mean 4-month serum concentrations of 25(OH)D3, 24R,25(OH)2D3, 1α,25(OH)2D3 and 4β,25(OH)2D3 and mean ratios of 25(OH)D3-to-D3 and 1α,25(OH)2D3-to-25(OH)D3', 'total 25(OH)D concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0020365', 'cui_str': 'Hydroxylation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0000343', 'cui_str': '25-Hydroxycalciferol'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}]",52.0,0.0303026,"Participants receiving vitamin D2 had lower mean post-supplementation ratios of 25(OH)D3-to-vitamin D3 and 1α,25(OH)2D3-to-25(OH)D3 than those receiving vitamin D3.","[{'ForeName': 'Adrian R', 'Initials': 'AR', 'LastName': 'Martineau', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Thummel', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Zhican', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Jolliffe', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Boucher', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Nita G', 'Initials': 'NG', 'LastName': 'Forouhi', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Hitman', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00207']
833,31422789,Vertebral artery stenting to prevent recurrent stroke in symptomatic vertebral artery stenosis: the VIST RCT.,"BACKGROUND
Symptomatic vertebral artery (VA) stenosis has been associated with a markedly increased early risk of recurrent stroke. VA stenosis can be treated with stenting; however, there are few data from randomised controlled trials evaluating the efficacy of this treatment, and recent studies in intracranial stenosis have suggested that stenting may be associated with increased risk.
OBJECTIVE
The Vertebral artery Ischaemia Stenting Trial (VIST) was established to compare the risks and benefits of vertebral angioplasty and stenting with best medical treatment (BMT) alone for recently symptomatic VA stenosis.
DESIGN
VIST was a prospective, randomised, open, parallel, blinded end-point clinical trial.
SETTING
The trial was performed in 14 hospitals in the UK.
PARTICIPANTS
Recruitment began on 23 October 2008 and follow-up ended on 1 March 2016, by which time every patient had been followed up for at least 1 year. Participants had to have symptomatic vertebral stenosis of at least 50% resulting from presumed atheromatous disease. Both patients and clinicians were aware of treatment allocation; however, an independent adjudication committee, masked to treatment allocation, assessed all primary and secondary end points.
INTERVENTIONS
Participants were randomly assigned (1 : 1) to either vertebral angioplasty/stenting plus BMT ( n = 91) or BMT alone ( n = 88). A total of 182 patients were initially enrolled; however, three patients (two who withdrew after randomisation and one who did not attend after the initial randomisation visit) did not contribute any follow-up data and were excluded. None of these three patients had outcome events.
MAIN OUTCOMES AND MEASURES
The primary end point was the occurrence of fatal or non-fatal stroke in any arterial territory during follow-up.
RESULTS
The median follow-up was 3.5 (interquartile range 2.1-4.7) years. Of the 61 patients who were stented, 48 (78.7%) had extracranial stenosis and 13 (21.3%) had intracranial stenosis. No perioperative complications occurred with extracranial stenting; two strokes occurred during intracranial stenting. The primary end point occurred in five patients (including one fatal stroke) in the stent group and in 12 patients (including two fatal strokes) in the medical group (giving a hazard ratio of 0.40, 95% confidence interval 0.14 to 1.13; p = 0.08), with an absolute risk reduction of 25 strokes per 1000 person-years.
LIMITATIONS
The study was underpowered because it failed to reach target recruitment. The high rate of non-confirmation of stenosis in the stented group of the trial was a second limitation.
CONCLUSIONS
The trial found no difference in risk of the primary end point between the two groups.
FUTURE
Post hoc analysis suggested that stenting could be associated with a reduced recurrent stroke risk in symptomatic VA and further studies are now required to confirm these findings, particularly in extracranial VA stenosis where complication rates with stenting were confirmed to be very low.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN95212240.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 41. See the NIHR Journals Library website for further project information. In addition, funding for the pilot phase was provided by the Stroke Association.",2019,"Of the 61 patients who were stented, 48 (78.7%) had extracranial stenosis and 13 (21.3%) had intracranial stenosis.","['symptomatic vertebral artery stenosis', '182 patients were initially enrolled; however, three patients (two who withdrew after randomisation and one who did not attend after the initial randomisation visit) did not contribute any follow-up data and were excluded', 'Recruitment began on 23 October 2008 and follow-up ended on 1 March 2016, by which time every patient had been followed up for at least 1 year', '14 hospitals in the UK']","['Vertebral artery stenting', 'vertebral angioplasty and stenting with best medical treatment (BMT) alone', 'vertebral angioplasty/stenting plus BMT', 'BMT alone']","['symptomatic vertebral stenosis', 'intracranial stenosis', 'one fatal stroke', 'perioperative complications', 'high rate of non-confirmation of stenosis', 'occurrence of fatal or non-fatal stroke', 'extracranial stenosis']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0265103', 'cui_str': 'Vertebral Artery Stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0559294', 'cui_str': 'Not attended'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0042559', 'cui_str': 'Vertebral Artery'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of (contextual qualifier) (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}]",182.0,0.172526,"Of the 61 patients who were stented, 48 (78.7%) had extracranial stenosis and 13 (21.3%) had intracranial stenosis.","[{'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Markus', 'Affiliation': 'Stroke Research Group, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Susanna C', 'Initials': 'SC', 'LastName': 'Larsson', 'Affiliation': 'Stroke Research Group, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dennis', 'Affiliation': 'Patient representative, London, UK.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Kuker', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ursula G', 'Initials': 'UG', 'LastName': 'Schulz', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clifton', 'Affiliation': ""Department of Neuroradiology, St George's Hospital, London, UK.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23410']
834,30710807,Young adults report increased pleasure from using e-cigarettes and smoking tobacco cigarettes when drinking alcohol.,"BACKGROUND
Cigarettes share a high rate of co-use with alcohol, particularly among young adults. Studies have demonstrated greater perceived pleasure from smoking cigarettes when drinking alcohol. However, little is known about co-use of electronic cigarettes (e-cigs) and alcohol. The current study sought to compare extent of use and perceived pleasure from cigarettes and e-cigs when drinking alcohol.
METHODS
Young adult bar patrons in California cities (San Diego, Los Angeles, and San Francisco) were recruited in 2015-16 using randomized time-location sampling. Participants completed cross-sectional surveys in bars, reporting the percent of cigarette smoking/e-cig use that occurred under the influence of alcohol, and reported if pleasure from smoking cigarettes/using e-cigs changed when drinking alcohol. Analyses are limited to participants reporting current (past 30-day) use of cigarettes, e-cigs, and alcohol (N = 269; M age = 24.1; 40.1% female, 36.1% Non-Hispanic White).
RESULTS
Participants reported a greater percentage of cigarette smoking compared to e-cig use under the influence of alcohol (cigarettes M = 63.6%; e-cigs M = 46.7%; p < .001). Participants also reported increased pleasure both from smoking cigarettes (M = 3.9; [compared to midpoint of scale 3 - ""no change""] p < .001) and using e-cigs (M = 3.3; p < .001) when drinking alcohol. The increase in pleasure was more pronounced for cigarettes compared to e-cigs (p < .001).
CONCLUSIONS
Drinking alcohol is associated with increases in perceived rewarding effects of both cigarettes and e-cigs and thus may increase their abuse liability. This effect may be stronger for cigarettes, which could be an important barrier to switching completely from smoking cigarettes to using e-cigs, or quitting both entirely.",2019,M = 63.6%; e-cigs M = 46.7%; p < .001).,"['young adults', 'participants reporting current (past 30-day) use of cigarettes, e-cigs, and alcohol (N\u202f=\u202f269; M age\u202f=\u202f24.1; 40.1% female, 36.1% Non-Hispanic White', 'Young adults', 'Young adult bar patrons in California cities (San Diego, Los Angeles, and San Francisco) were recruited in 2015-16 using randomized time-location sampling', 'Participants completed cross-sectional surveys in bars, reporting the percent of cigarette smoking/e-cig use that occurred under the influence of alcohol, and reported if pleasure from smoking cigarettes/using e-cigs changed when drinking alcohol']",['alcohol (cigarettes'],"['cigarette smoking', 'pleasure both from smoking cigarettes', 'pleasure']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0556297', 'cui_str': 'Current drinker of alcohol (finding)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",,0.0192523,M = 63.6%; e-cigs M = 46.7%; p < .001).,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, United States. Electronic address: jthrul@jhu.edu.'}, {'ForeName': 'Noah R', 'Initials': 'NR', 'LastName': 'Gubner', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, United States; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, United States.'}, {'ForeName': 'Chiara L', 'Initials': 'CL', 'LastName': 'Tice', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, United States.'}, {'ForeName': 'Nadra E', 'Initials': 'NE', 'LastName': 'Lisha', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, United States; Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, United States.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Ling', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, United States; Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.01.011']
835,31135812,Association of Nonfasting vs Fasting Lipid Levels With Risk of Major Coronary Events in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm.,"Importance
Recent guidelines have recommended nonfasting for routine testing of lipid levels based on comparisons of nonfasting and fasting populations. However, no previous study has examined the association of cardiovascular outcomes with fasting vs nonfasting lipid levels measured in the same individuals.
Objective
To compare the association of nonfasting and fasting lipid levels with prospectively ascertained coronary and vascular outcomes and to evaluate whether a strategy of using nonfasting instead of fasting lipid level measurement would result in misclassification of risk for individuals undergoing evaluation for initiation of statin therapy.
Design, Setting, and Participants
This post hoc prospective follow-up of a randomized clinical trial included 8270 of 10 305 participants from the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA) with nonfasting and fasting lipid levels measured 4 weeks apart (including 6855 participants with no prior vascular disease) (median follow-up, 3.3 years; interquartile range, 2.8-3.6 years). Data were collected from February 1, 1998, to December 31, 2002, and analyzed from February 1, 2016, to November 30, 2018. Multivariable Cox models, adjusted for cardiovascular risk factors, were calculated for 40-mg/dL (1-mmol/L) higher values of nonfasting and fasting lipids.
Main Outcomes and Measures
The trial's primary end point consisted of major coronary events (nonfatal myocardial infarction [MI] and fatal coronary heart disease [212 events]). Secondary analyses examined atherosclerotic cardiovascular disease (ASCVD) events (including MI, stroke, and ASCVD death [351 events]).
Results
Among the 8270 participants (82.1% male; mean [SD] age, 63.4 [8.5] years), nonfasting samples had modestly higher triglyceride levels and similar cholesterol levels compared to fasting samples. Associations of nonfasting lipid levels with coronary events were similar to those for fasting lipid levels. For example, adjusted hazard ratios (HRs) per 40-mg/dL of low-density lipoprotein cholesterol were 1.32 (95% CI, 1.08-1.61; P = .007) for nonfasting levels and 1.28 (95% CI, 1.07-1.55; P = .008) for fasting levels. For the primary prevention group, adjusted HRs were 1.42 (95% CI, 1.13-1.78; P = .003) for nonfasting levels and 1.37 (95% CI, 1.11-1.69; P = .003) for fasting levels. Results were consistent by randomized treatment arm (atorvastatin calcium, 10 mg/d, or placebo) and similar for ASCVD events. Concordance of fasting and nonfasting lipid levels for classifying participants into appropriate ASCVD risk categories was high (94.8%).
Conclusions and Relevance
Measurement of nonfasting and fasting lipid levels yields similar results in the same individuals for association with incident coronary and ASCVD events. These results suggest that routine measurement of nonfasting lipid levels may help facilitate ASCVD risk screening and treatment, including consideration of when to initiate statin therapy.",2019,"For the primary prevention group, adjusted HRs were 1.42 (95% CI, 1.13-1.78; P = .003) for nonfasting levels and 1.37 (95% CI, 1.11-1.69; P = .003) for fasting levels.","['individuals undergoing evaluation for initiation of statin therapy', 'Data were collected from February 1, 1998, to December 31, 2002, and analyzed from February 1, 2016, to November 30, 2018', '8270 of 10\u202f305 participants from the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA) with nonfasting and fasting lipid levels measured 4 weeks apart (including 6855 participants with no prior vascular disease) (median follow-up, 3.3 years; interquartile range, 2.8-3.6 years', '8270 participants (82.1% male; mean [SD] age, 63.4 [8.5] years']","['atorvastatin calcium', 'placebo']","['atherosclerotic cardiovascular disease (ASCVD) events (including MI, stroke, and ASCVD death [351 events', 'major coronary events (nonfatal myocardial infarction [MI] and fatal coronary heart disease [212 events', 'Association of Nonfasting vs Fasting Lipid Levels', 'cardiovascular risk factors', 'Concordance of fasting and nonfasting lipid levels', 'low-density lipoprotein cholesterol', 'nonfasting lipid levels', 'triglyceride levels and similar cholesterol levels', 'nonfasting levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0240951', 'cui_str': 'Scandinavian'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2585491', 'cui_str': 'Nonfasting'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0286650', 'cui_str': 'Atorvastatin calcium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2585491', 'cui_str': 'Nonfasting'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",10305.0,0.0492221,"For the primary prevention group, adjusted HRs were 1.42 (95% CI, 1.13-1.78; P = .003) for nonfasting levels and 1.37 (95% CI, 1.11-1.69; P = .003) for fasting levels.","[{'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Center for Lipid Metabolomics, Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'C Lan', 'Initials': 'CL', 'LastName': 'Chang', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'M Vinayaga', 'Initials': 'MV', 'LastName': 'Moorthy', 'Affiliation': ""Center for Lipid Metabolomics, Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0392']
836,30477333,Implementation of Occupational Sun Safety at a 2-Year Follow-Up in a Randomized Trial: Comparison of Sun Safe Workplaces Policy Intervention to Attention Control.,"PURPOSE
Implementation of employer sun safety actions was assessed in a 2-year follow-up to an occupational sun protection policy intervention.
DESIGN
Two-year follow-up assessment in a randomized pretest-posttest controlled design.
SETTING
Local government organizations with workers in public safety, public works, and parks and recreation.
PARTICIPANTS
Sixty-three local government organizations (participation = 64%) and 330 frontline supervisors and 1454 workers.
INTERVENTION
Sun Safe Workplaces (SSW) intervention promoting occupational sun safety policy and education.
MEASURES
Observations of SSW messages and sun safety items and surveys on organizations' communication and actions on sun safety.
ANALYSIS
Comparison between SSW and control groups was conducted using regression models and adjusted for clustering where appropriate, with α criterion set at P = .05 (2-tailed).
RESULTS
At intervention worksites, more SSW messages ( P < .001) and sun safety items ( P = .025) were observed; more frontline supervisors reported organizations provided free/reduced price sunscreen ( P = .005) and communicated about sun safety ( P < .001); and more workers recalled receiving sun safety messages ( P < .001) and sun safety training ( P <.001) compared to control organizations. Implementation was greater at larger than smaller intervention organizations for wide-brimmed hats ( P = .009), long work pants ( P = .017), and shade structures ( P = .036). Older workers received the most written messages ( P = .015).
CONCLUSIONS
Sun Safe Workplaces appeared to produce actions by organizations to support employee sun safety. Large organizations may have processes, communication channels, and slack resources to achieve more implementation.",2019,"Implementation was greater at larger than smaller intervention organizations for wide-brimmed hats ( P = .009), long work pants ( P = .017), and shade structures ( P = .036).","['Local government organizations with workers in public safety, public works, and parks and recreation', 'Older workers', 'Sixty-three local government organizations (participation = 64%) and 330 frontline supervisors and 1454 workers']","['Sun Safe Workplaces (SSW) intervention promoting occupational sun safety policy and education', 'Sun Safe Workplaces Policy Intervention']","['price sunscreen', 'SSW messages', 'sun safety training', 'sun safety', 'sun safety items', ""SSW messages and sun safety items and surveys on organizations' communication and actions on sun safety""]","[{'cui': 'C0026788', 'cui_str': 'Local Government'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}]","[{'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",,0.0351092,"Implementation was greater at larger than smaller intervention organizations for wide-brimmed hats ( P = .009), long work pants ( P = .017), and shade structures ( P = .036).","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': '1 Klein Buendel, Inc, Lakewood, CA, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': '1 Klein Buendel, Inc, Lakewood, CA, USA.'}, {'ForeName': 'Mary Klein', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': '1 Klein Buendel, Inc, Lakewood, CA, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Wallis', 'Affiliation': '2 School of Public Affairs, University of Colorado Denver, Denver, CO, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Andersen', 'Affiliation': '3 School of Communication, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Scott', 'Affiliation': '4 Mikonics, Inc, Santa Fe, NM, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Meenan', 'Affiliation': '5 Kaiser Permanente, Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': '6 Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117118814398']
837,30088145,A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment.,"Intimate partner victimization (IPV) during the perinatal period is associated with adverse outcomes for the woman, her developing fetus, and any children in her care. Maternal mental health concerns, including depression and anxiety, are prevalent during the perinatal period particularly among women experiencing IPV. Screening and interventions for IPV targeting women seeking mental health treatment are lacking. In the current study, we examine the feasibility, acceptability, and the preliminary efficacy of a brief, motivational computer-based intervention, SURE (Strength for U in Relationship Empowerment), for perinatal women with IPV seeking mental health treatment. The study design was a two-group, randomized controlled trial with 53 currently pregnant or within 6-months postpartum women seeking mental health treatment at a large urban hospital-based behavioral health clinic for perinatal women. Findings support the acceptability and feasibility of the SURE across a number of domains including content, delivery, and retention. All participants (100%) found the information and resources in SURE to be helpful. Our preliminary results found the degree of IPV decreased significantly from baseline to the 4-month follow-up for the SURE condition (paired t-test, p < 0.001), while the control group was essentially unchanged. Moreover, there was a significant reduction in emotional abuse for SURE participants (p = 0.023) relative to participants in the control condition. There were also reductions in physical abuse although non-significant (p = 0.060). Future work will test SURE in a larger, more diverse sample. ClinicalTrials.gov Identifier: NCT02370394.",2019,"Moreover, there was a significant reduction in emotional abuse for SURE participants (p = 0.023) relative to participants in the control condition.","['53 currently pregnant or within 6-months postpartum women seeking mental health treatment at a large urban hospital-based behavioral health clinic for perinatal women', 'victimized perinatal women seeking mental health treatment', 'perinatal women with IPV seeking mental health treatment', 'women experiencing IPV']","['Intimate partner victimization (IPV', 'computer-based brief intervention', 'motivational computer-based intervention, SURE (Strength for U in Relationship Empowerment']","['degree of IPV', 'emotional abuse', 'physical abuse']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]","[{'cui': 'C0699756', 'cui_str': 'Intimate (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse (event)'}, {'cui': 'C1621955', 'cui_str': 'Physical Maltreatment'}]",53.0,0.0491485,"Moreover, there was a significant reduction in emotional abuse for SURE participants (p = 0.023) relative to participants in the control condition.","[{'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA. czlotnick@butler.org.'}, {'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': 'Department of Medicine at Women and Infants Hospital, Providence, RI, USA.'}]",Archives of women's mental health,['10.1007/s00737-018-0895-1']
838,32147485,No Difference in Functional Outcomes When Lateral Extra-Articular Tenodesis Is Added to Anterior Cruciate Ligament Reconstruction in Young Active Patients: The Stability Study.,"PURPOSE
To assess the functional outcomes of patients included in the Stability Study randomized controlled trial comparing anterior cruciate ligament reconstruction (ACLR) alone with ACLR with lateral extra-articular tenodesis (LET) at 6, 12, and 24 months postoperatively.
METHODS
Six hundred eighteen patients undergoing ACLR, all under the age of 25 years either returning to contact pivoting sport or displaying signs of high-grade rotatory laxity or generalized ligamentous laxity, were randomly assigned to receive ACLR alone or ACLR plus LET. A total of 356 of these patients were randomized at centers participating in the functional assessments. Our primary outcome was Limb Symmetry Index, calculated using a series of 4-hop tests at 6, 12, and 24 months postoperatively. Secondary outcome measures included pain, patient-reported function, and isokinetic strength testing.
RESULTS
We found no statistically significant difference in the proportion of patients either unwilling or unfit to complete the hop testing in the ACLR alone or ACLR with LET group at 6 months (40 vs 40 respectively; P = 1.00), 12 months (25 vs 27; P = .76), and 24 months (21 vs 23; P = .87). Of those who completed hop testing, there were no statistically significant differences between groups in Limb Symmetry Index at 6, 12, or 24 months. Self-reported function (Lower Extremity Functional Score) significantly favored the ACLR alone group at 3 (P = .01) and 6 months (P = .02) postoperative but was similar by 12 months postoperative. Pain scores (P4) also showed a statistically significant difference in favor of the ACL alone group, but this also resolved by 6 months. Quadriceps peak torque (P = .03) and average power (P = .01) were also significantly different in favor of the ACLR alone group at 6 months postoperative; however, these were similar between groups by 12 months postoperative (P = .11 and P = .32, respectively).
CONCLUSIONS
The addition of a LET to ACLR results in slightly increased pain, a mild reduction in quadriceps strength, and reduced subjective functional recovery up to 6 months postoperatively. However, these differences do not have any impact on objective function as measured by hop test limb symmetry index.
LEVEL OF EVIDENCE
I, Randomized Controlled Trial.",2020,"Quadriceps peak torque (p=0.03) and average power (p=0.01) were also significantly different in favor of the ACLR alone group at 6 months postoperative; however, these were similar between groups by 12 months post-operative (p=0.11and p=0.32 respectively).
","['young active patients', 'Six hundred and eighteen patients undergoing ACLR, all under the age of 25 either returning to contact pivoting sport or displaying signs of high grade rotatory laxity or generalized ligamentous laxity', 'A total of 356 of these patients were randomized at centers participating in the functional assessments']","['anterior cruciate ligament reconstruction (ACLR) alone to ACLR with lateral extra-articular tenodesis (LET', 'ACLR alone or ACLR plus LET', 'Anterior Cruciate Ligament Reconstruction']","['Functional Outcomes', 'quadriceps strength and reduced subjective functional recovery', 'pain', 'Pain scores (P4', 'Self-reported function (Lower Extremity Functional Score', 'Quadriceps peak torque', 'Limb Symmetry Index (LSI', 'pain, patient-reported function and isokinetic strength testing']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular (qualifier value)'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",618.0,0.0864832,"Quadriceps peak torque (p=0.03) and average power (p=0.01) were also significantly different in favor of the ACLR alone group at 6 months postoperative; however, these were similar between groups by 12 months post-operative (p=0.11and p=0.32 respectively).
","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Getgood', 'Affiliation': 'Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada; Lawson Health Research Institute, London, Ontario, Canada; London Health Sciences Centre, London, Ontario, Canada. Electronic address: alan.getgood@uwo.ca.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hewison', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada; Faculty of Health Sciences, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Litchfield', 'Affiliation': 'Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada; Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heard', 'Affiliation': 'Banff Sport Medicine, Banff, Alberta, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Buchko', 'Affiliation': 'Banff Sport Medicine, Banff, Alberta, Canada.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Hiemstra', 'Affiliation': 'Banff Sport Medicine, Banff, Alberta, Canada.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Willits', 'Affiliation': 'Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada; Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Firth', 'Affiliation': 'Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada; Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'MacDonald', 'Affiliation': 'Pan Am Clinic, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.02.015']
839,31422486,The HDL lipidome is widely remodeled by fast food versus Mediterranean diet in 4 days.,"INTRODUCTION
HDL is associated with increased longevity and protection from multiple chronic diseases. The major HDL protein ApoA-I has a half-life of about 4 days, however, the effects of diet on the composition of HDL particles at this time scale have not been studied.
OBJECTIVES
The objective of this study is to investigate the short term dietary effect on HDL lipidomic composition.
METHODS
In this randomized order cross-over study, ten healthy subjects consumed a Mediterranean (Med) and a fast food (FF) diet for 4 days, with a 4-day wash-out between treatments. Lipidomic composition was analyzed in isolated HDL fractions by an untargeted LC-MS method with 15 internal standards.
RESULTS
HDL phosphatidylethanolamine (PE) content was increased by FF diet, and 41 out of 170 lipid species were differentially affected by diet. Saturated fatty acids (FAs) and odd chain FA were enriched after FF diet, while very-long chain FA and unsaturated FA were enriched after Med diet. The composition of phosphatidylcholine (PC), triacylglycerol (TG) and cholesteryl ester (CE) were significantly altered to reflect the FA composition of the diet whereas the composition of sphingomyelin (SM) and ceramides were generally unaffected.
CONCLUSION
Results from this study indicate that the HDL lipidome is widely remodeled within 4 days of diet change and that certain lipid classes are more sensitive markers of diet whereas other lipid classes are better indicators of non-dietary factors.",2019,"RESULTS
HDL phosphatidylethanolamine (PE) content was increased by FF diet, and 41 out of 170 lipid species were differentially affected by diet.",['ten healthy subjects consumed a Mediterranean (Med) and a'],"['fast food (FF) diet', 'Saturated fatty acids (FAs) and odd chain FA']","['Lipidomic composition', 'HDL phosphatidylethanolamine (PE) content', 'composition of phosphatidylcholine (PC), triacylglycerol (TG) and cholesteryl ester (CE']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0031618', 'cui_str': 'Phosphatidylethanolamines'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1959616', 'cui_str': 'Phosphatidyl Cholines'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008387', 'cui_str': 'Cholesteryl Esters'}]",10.0,0.0170777,"RESULTS
HDL phosphatidylethanolamine (PE) content was increased by FF diet, and 41 out of 170 lipid species were differentially affected by diet.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, 95616, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, 95616, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beals', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, 95616, USA.'}, {'ForeName': 'Riley L', 'Initials': 'RL', 'LastName': 'Hughes', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, 95616, USA.'}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'Rhodes', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, 95616, USA.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, 95616, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, 95616, USA. amzivkovic@ucdavis.edu.'}]",Metabolomics : Official journal of the Metabolomic Society,['10.1007/s11306-019-1579-1']
840,31427272,Adaptive current tDCS up to 4 mA.,"BACKGROUND
Higher tDCS current may putatively enhance efficacy, with tolerability the perceived limiting factor.
OBJECTIVE
We designed and validated electrodes and an adaptive controller to provide tDCS up to 4 mA, while managing tolerability. The adaptive 4 mA controller included incremental ramp up, impedance-based current limits, and a Relax-mode where current is transiently decreased. Relax-mode was automatically activated by self-report VAS-pain score >5 and in some conditions by a Relax-button available to participants.
METHODS
In a parallel-group participant-blind design with 50 healthy subjects, we used specialized electrodes to administer 3 daily session of tDCS for 11 min, with a lexical decision task as a distractor, in 5 study conditions: adaptive 4 mA, adaptive 4 mA with Relax-button, adaptive 4 mA with historical-Relax-button, 2 mA, and sham. A tablet-based stimulator with a participant interface regularly queried VAS pain score and also limited current based on impedance and tolerability. An Abort-button provided in all conditions stopped stimulation. In the adaptive 4 mA with Relax-button and adaptive 4 mA with historical-Relax-button conditions, participants could trigger a Relax-mode ad libitum, in the latter case with incrementally longer current reductions. Primary outcome was the average current delivered during each session, VAS pain score, and adverse event questionnaires. Current delivered was analyzed either excluding or including dropouts who activated Abort (scored as 0 current).
RESULTS
There were two dropouts each in the adaptive 4 mA and sham conditions. Resistance based current attenuation was rarely activated, with few automatic VAS pain score triggered relax-modes. In conditions with Relax-button option, there were significant activations often irrespective of VAS pain score. Including dropouts, current across conditions were significantly different from each other with maximum current delivered during adaptive 4 mA with Relax-button. Excluding dropouts, maximum current was delivered with adaptive 4 mA. VAS pain score and adverse events for the sham was only significantly lower than the adaptive 4 mA with Relax-button and adaptive 4 mA with historical-Relax-button. There was no difference in VAS pain score or adverse events between 2 mA and adaptive 4 mA.
CONCLUSIONS
Provided specific electrodes and controllers, adaptive 4 mA tDCS is tolerated and effectively blinded, with acceptability likely higher in a clinical population and absence of regular querying. Indeed, presenting participants with overt controls increases rumination on sensation.",2020,There was no difference in VAS pain score or adverse events between 2 mA and adaptive 4 ,['50 healthy subjects'],"['tDCS for 11\u202fmin, with a lexical decision task as a distractor, in 5 study conditions: adaptive 4\u202fmA, adaptive 4\u202fmA with Relax-button, adaptive 4\u202fmA with historical-Relax-button, 2\u202fmA, and sham']","['VAS pain score', 'VAS pain score or adverse events', 'rumination on sensation', 'VAS pain score and adverse events', 'average current delivered during each session, VAS pain score, and adverse event questionnaires']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0453985', 'cui_str': 'Button, device (physical object)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0487575,There was no difference in VAS pain score or adverse events between 2 mA and adaptive 4 ,"[{'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Khadka', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, CUNY, New York, NY, 10031, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Borges', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, CUNY, New York, NY, 10031, USA.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Paneri', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, CUNY, New York, NY, 10031, USA.'}, {'ForeName': 'Trynia', 'Initials': 'T', 'LastName': 'Kaufman', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, CUNY, New York, NY, 10031, USA.'}, {'ForeName': 'Electra', 'Initials': 'E', 'LastName': 'Nassis', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, CUNY, New York, NY, 10031, USA.'}, {'ForeName': 'Adantchede L', 'Initials': 'AL', 'LastName': 'Zannou', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, CUNY, New York, NY, 10031, USA.'}, {'ForeName': 'Yungjae', 'Initials': 'Y', 'LastName': 'Shin', 'Affiliation': 'Ybrain Inc., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Hyeongseob', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Ybrain Inc., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Seonghoon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Ybrain Inc., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Kiwon', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Ybrain Inc., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York, CUNY, New York, NY, 10031, USA. Electronic address: bikson@ccny.cuny.edu.'}]",Brain stimulation,['10.1016/j.brs.2019.07.027']
841,32146133,Electromyographic Evaluation of the Pelvic Muscles Activity After High-Intensity Focused Electromagnetic Procedure and Electrical Stimulation in Women With Pelvic Floor Dysfunction.,"INTRODUCTION
Impaired coordination, relaxation, and atrophy of pelvic floor muscles (PFMs) may cause various health issues referred to as pelvic floor dysfunction (PFD). In recent years, electromagnetic noninvasive stimulation of the pelvic floor was successfully used to treat PFD symptoms.
AIM
This study aims to compare the effectiveness of electrical and magnetic noninvasive stimulation for the treatment of PFD in postpartum women.
METHODS
2 intervention groups treated with high-intensity focused electromagnetic ([HIFEM]; G1) procedure and electrical stimulation (G2) were established along with the control group (G3). Patients received 10 therapies delivered at the hospital (G1; 2-3 times per week) or self-administered at home (G2; every other day) after initial training. The protocol was identical for both modalities. Functionality of the PFM was examined by surface electromyography measurements (maximal voluntary contraction [MVC]; mean MVC; muscle activity at rest; endurance of contraction) while patient's subjective perception of pelvic floor functionality was assessed by Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) standardized questionnaire. Changes in electromyography values and PFIQ-7 scores were statistically evaluated from baseline to after all treatments.
MAIN OUTCOME MEASURE
The main outcome measure was enhancement of PFM activity.
RESULTS
In total, 95 patients (G1 = 50; G2 = 25; G3 = 20) participated in the study. The MVC, mean MVC, and endurance were lowered in symptomatic patients. After the treatments, these parameters significantly increased (P < .001) and moved toward the values of healthy population. Electrogenesis at relaxation revealed divergent tendencies in the G1 and G2 groups. PFIQ-7 scores significantly improved in treated patients (P < .001). In general, superior results were documented in the HIFEM group as it reached improvement of electromyography parameters from 48% to 59% (electrical stimulation from 7% to 36%) and similarly the improvement of PFIQ-7 score by 57% (electrical stimulation by 32%).
CONCLUSION
This study documented that the HIFEM procedure was significantly more effective than electrical stimulation in treatment of PFD in postpartum women. Both the objective and subjective evaluation indicates more profound effects of magnetic stimulation. Elena S, Dragana Z, Ramina S, et al. Electromyographic Evaluation of the Pelvic Muscles Activity After High-Intensity Focused Electromagnetic Procedure and Electrical Stimulation in Women With Pelvic Floor Dysfunction. Sex Med 2020;8:282-289.",2020,"After the treatments, these parameters significantly increased (P < .001) and moved toward the values of healthy population.","['Women With Pelvic Floor Dysfunction', '95 patients (G1\xa0=\xa050; G2\xa0=\xa025; G3\xa0=\xa020) participated in the study', 'postpartum women']","['high-intensity focused electromagnetic ([HIFEM]; G1) procedure and electrical stimulation (G2', 'Electromagnetic Procedure and Electrical Stimulation', 'electrical and magnetic noninvasive stimulation']","[""surface electromyography measurements (maximal voluntary contraction [MVC]; mean MVC; muscle activity at rest; endurance of contraction) while patient's subjective perception of pelvic floor functionality"", 'MVC, mean MVC, and endurance', 'PFIQ-7 score', 'PFIQ-7 scores', 'enhancement of PFM activity', 'Elena S, Dragana Z, Ramina S, et', 'Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) standardized questionnaire', 'electromyography values and PFIQ-7 scores', 'electromyography parameters', 'Pelvic Muscles Activity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0448421', 'cui_str': 'Skeletal muscle structure of pelvis'}]",95.0,0.0575187,"After the treatments, these parameters significantly increased (P < .001) and moved toward the values of healthy population.","[{'ForeName': 'Silantyeva', 'Initials': 'S', 'LastName': 'Elena', 'Affiliation': 'Hospital Lapino (MD Medical Group), Moscow, Russia. Electronic address: essdoktor@yandex.ru.'}, {'ForeName': 'Zarkovic', 'Initials': 'Z', 'LastName': 'Dragana', 'Affiliation': 'Faculty of Physical Education and Sport, Department of Anatomy and Biomechanics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Soldatskaia', 'Initials': 'S', 'LastName': 'Ramina', 'Affiliation': 'Hospital Lapino (MD Medical Group), Moscow, Russia.'}, {'ForeName': 'Astafeva', 'Initials': 'A', 'LastName': 'Evgeniia', 'Affiliation': 'Hospital Lapino (MD Medical Group), Moscow, Russia.'}, {'ForeName': 'Mekan', 'Initials': 'M', 'LastName': 'Orazov', 'Affiliation': 'Medical Faculty, Department of Obstetrics and Gynecology, RUDN University, Moscow, Russia.'}]",Sexual medicine,['10.1016/j.esxm.2020.01.004']
842,31278102,Clinical trial protocol of doublet therapy and olanzapine for carboplatin-induced nausea and vomiting in patients with thoracic cancer: a multicentre phase II trial.,"INTRODUCTION
Adding neurokinin-1 receptor antagonist (NK 1 RA) to 5-hydroxytryptamine-3 receptor antagonist and dexamethasone (DEX) improved carboplatin (CBDCA)-induced chemotherapy-induced nausea and vomiting (CINV) in patients with thoracic cancer. NK 1 RAs with high-drug cost are raising medical expenses. Olanzapine (OLZ) is less expensive and can be expected to have an excellent effect on CINV. This phase II trial aimed at evaluating the efficacy and safety of 5 mg OLZ plus granisetron (GRN) and DEX in CBDCA combination therapy with area under curve (AUC) ≥5 mg/mL/min for the prevention of nausea and vomiting in patients with thoracic cancer.
METHODS AND ANALYSIS
This is an open-label, single-arm, multicentre, phase II trial. Patients who receive CBDCA-based therapies (AUC ≥5) and have never been administered moderate to high emetogenic chemotherapy will be enrolled. All patients will receive a combination of GRN, DEX and OLZ. The primary endpoint is complete response (CR) rate, defined as the absence of emetic episodes and no use of rescue medication for 120 hours after the initiation of CBDCA. Forty-eight patients are required based on our hypothesis that this regimen can improve CR rate from 65% (null hypothesis) to 80% (alternative hypothesis) with a one-sided type I error of 0.1 and a power of 0.8. We set the target sample size at 50 considering dropouts.
ETHICS AND DISSEMINATION
The study protocol was approved by the institutional review board at each of the participating centres. Data will be presented at international conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
UMIN000031267.",2019,Adding neurokinin-1 receptor antagonist (NK 1 RA) to 5-hydroxytryptamine-3 receptor antagonist and dexamethasone (DEX) improved carboplatin (CBDCA)-induced chemotherapy-induced nausea and vomiting (CINV) in patients with thoracic cancer.,"['Patients who receive CBDCA-based therapies (AUC ≥5) and have never been administered moderate to high emetogenic chemotherapy will be enrolled', 'patients with thoracic cancer']","['GRN, DEX and OLZ', 'OLZ plus granisetron (GRN) and DEX', 'Olanzapine (OLZ', '5-hydroxytryptamine-3 receptor antagonist and dexamethasone (DEX) improved carboplatin (CBDCA)-induced chemotherapy', 'olanzapine']","['nausea and vomiting', 'nausea and vomiting (CINV', 'efficacy and safety', 'complete response (CR) rate, defined as the absence of emetic episodes and no use of rescue medication', 'CR rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4521929', 'cui_str': '5-HT3 receptor antagonist'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0013973', 'cui_str': 'Emetic Agents'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",1.0,0.0935342,Adding neurokinin-1 receptor antagonist (NK 1 RA) to 5-hydroxytryptamine-3 receptor antagonist and dexamethasone (DEX) improved carboplatin (CBDCA)-induced chemotherapy-induced nausea and vomiting (CINV) in patients with thoracic cancer.,"[{'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Iihara', 'Affiliation': 'Department of Pharmacy, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Shimokawa', 'Affiliation': 'Cancer Biostatistics Laboratory, Clinical Research Institute, National Hospital Organization Kyusyu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Takenobu', 'Initials': 'T', 'LastName': 'Gomyo', 'Affiliation': 'Department of Cardiology and Respirology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Yukiyoshi', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Division of Pharmacy, Gunma Prefectural Cancer Center, Ohta, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Respiratory Medicine and Medical Oncology, Gifu Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Funaguchi', 'Affiliation': 'Department of Cardiology and Respirology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Minato', 'Affiliation': 'Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Gifu, Japan.'}, {'ForeName': 'Daizo', 'Initials': 'D', 'LastName': 'Kaito', 'Affiliation': 'Department of Cardiology and Respirology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Osawa', 'Affiliation': 'Department of Pharmacy, Gifu Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Department of Pharmacy, Asahi University Hospital, Gifu, Japan.'}, {'ForeName': 'Chiemi', 'Initials': 'C', 'LastName': 'Hirose', 'Affiliation': 'Department of Pharmacy, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Pharmacy, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ohno', 'Affiliation': 'Department of Cardiology and Respirology, Gifu University Graduate School of Medicine, Gifu, Japan.'}]",BMJ open,['10.1136/bmjopen-2018-028056']
843,31219027,HPV testing compared with routine cytology in cervical screening: long-term follow-up of ARTISTIC RCT.,"BACKGROUND
The National Screening Committee (NSC) based its recommendation that human papillomavirus (HPV) testing should replace cytology in primary cervical screening largely on the 2009 follow-up results of the ARTISTIC trial (A Randomised Trial In Screening To Improve Cytology). The NSC must now decide on screening intervals and triage policy. Options include extending the screening interval up to 10 years for human papillomavirus-negative (HPV-) women, delaying recall for human papillomavirus-positive (HPV+) women with normal cytology (as their infections are usually transient), and basing triage on full HPV typing.
METHODS
In ARTISTIC, 24,510 women were recruited who were attending routine cervical cytology in Greater Manchester in 2001-3. The women were randomly allocated between revealing and concealing their HPV test results and were recalled every 3 years. After 2009, the women returned to routine cytological screening with recall every 3 years for those aged < 50 years, and every 5 years for those aged 50-64 years. We have followed the cohort to 2015 through national cancer registration for CIN3 (cervical intraepithelial neoplasia grade 3) and cancer, and through linkage to the cervical screening call-recall system to obtain lifetime cytology records.
RESULTS
The analysis comprised 24,496 women at round 1 and 13,591 women at round 2 (which was 30-48 months later). Follow-up via local histology laboratories and national cancer registration identified 505 cases of cervical intraepithelial neoplasia grade 3 or cervical cancer (CIN3+) (including 22 invasive cervical cancers). The cumulative CIN3+ risk 10 years after a negative HPV test [0.31%, 95% confidence interval (CI) 0.18% to 0.49%, in the revealed arm] was similar to that 3 years after negative cytology (0.30%, 95% CI 0.23% to 0.41%, in the concealed arm) and fell sharply with age, from 1.1% (95% CI 0.7% to 1.8%) in those women aged < 25 years to 0.08% (95% CI 0.03% to 0.20%) in those women aged > 50 years. The 10-year cumulative CIN3+ risk following a new HPV infection at round 2 was 3.4% (95% CI 2.1% to 5.4%). The highest risks were associated with type-specific persistent infections that, overall, resulted in a 10-year cumulative CIN3+ risk of 20.4% (95% CI 15.6% to 26.4%).
CONCLUSIONS
We found a similar level of protection 10 years after a negative HPV test and 3 years after negative cytology. These data support a considerably longer screening interval after a negative HPV test than after a negative cytology test. About three-quarters of women with HPV infection and normal cytology clear their infections within about 3 years. Their risk of CIN3+ within this time frame is low (1.5%), suggesting that the current policy of annual repeat testing and referral after 2 years may be unnecessarily cautious. Approximately 40% of women who remained HPV+ had cleared their initial infection and acquired a new HPV type. The cumulative CIN3+ risks in women with type-specific persistent infections are about six times higher than in women with new infections. Triage strategies based on HPV persistence would, therefore, reduce unnecessary referral of women with new (and largely transient) infections. HPV assays that identify HPV types 31, 33, 45, 52 and 58 in addition to 16 and 18 could be useful in triage as well as in primary HPV testing. Similar results in recent routine HPV screening suggest that our results are generalisable despite changes in cytology and HPV assay methods. We are continuing to follow the ARTISTIC cohort into the new era of primary HPV screening. Future work will focus on the implications of more sensitive HPV testing for primary HPV screening policy and triage of HPV-positive women. Our results suggest that a more sensitive test is needed to detect occult CIN3 at high risk of progression to cancer, but this would substantially increase the overall HPV detection rate. Tests such as DNA (deoxyribonucleic acid) methylation for distinguishing HPV infection from neoplasia will be evaluated on stored samples and on further samples now being collected from women in the cohort who are still being screened.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 28. See the NIHR Journals Library website for further project information.",2019,"The cumulative CIN3+ risk 10 years after a negative HPV test [0.31%, 95% confidence interval (CI) 0.18% to 0.49%, in the revealed arm] was similar to that 3 years after negative cytology (0.30%, 95% CI 0.23% to 0.41%, in the concealed arm) and fell sharply with age, from 1.1% (95% CI 0.7% to 1.8%) in those women aged < 25 years to 0.08% (95% CI 0.03% to 0.20%) in those women aged > 50 years.","['24,510 women were recruited who were attending routine cervical cytology in Greater Manchester in 2001-3', 'After 2009, the women returned to routine cytological screening with recall every 3 years for those aged <\u200950 years, and every 5 years for those aged 50-64 years', 'women with type-specific persistent infections', 'women in the cohort who are still being screened', '505 cases of cervical intraepithelial neoplasia grade 3 or cervical cancer (CIN3+) (including 22 invasive cervical cancers', '24,496 women at round 1 and 13,591 women at round 2 (which was 30-48 months later']","['routine cytology', 'deoxyribonucleic acid) methylation', 'DNA ']","['10-year cumulative CIN3+ risk', 'cumulative CIN3+ risks', 'overall HPV detection rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0856201', 'cui_str': 'Cervical cytology'}, {'cui': 'C0454856', 'cui_str': 'Greater Manchester (geographic location)'}, {'cui': 'C1723187', 'cui_str': '3-(4-dimethylaminophenyl)-N-hydroxy-2-propenamide'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205471', 'cui_str': 'Cytologic (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1334177', 'cui_str': 'Cancer of uterine cervix, invasive'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",24510.0,0.170757,"The cumulative CIN3+ risk 10 years after a negative HPV test [0.31%, 95% confidence interval (CI) 0.18% to 0.49%, in the revealed arm] was similar to that 3 years after negative cytology (0.30%, 95% CI 0.23% to 0.41%, in the concealed arm) and fell sharply with age, from 1.1% (95% CI 0.7% to 1.8%) in those women aged < 25 years to 0.08% (95% CI 0.03% to 0.20%) in those women aged > 50 years.","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Gilham', 'Affiliation': 'Non-Communicable Disease Epidemiology Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sargent', 'Affiliation': 'Department of Virology, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Kitchener', 'Affiliation': ""School of Cancer and Sciences, University of Manchester, St Mary's Hospital, Manchester, UK.""}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Peto', 'Affiliation': 'Non-Communicable Disease Epidemiology Unit, London School of Hygiene & Tropical Medicine, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23280']
844,31263284,Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study.,"Metabolic syndrome is characterized by a constellation of comorbidities that predispose individuals to an increased risk of developing cardiovascular pathologies as well as type 2 diabetes mellitus 1 . The gut microbiota is a new key contributor involved in the onset of obesity-related disorders 2 . In humans, studies have provided evidence for a negative correlation between Akkermansia muciniphila abundance and overweight, obesity, untreated type 2 diabetes mellitus or hypertension 3-8 . Since the administration of A. muciniphila has never been investigated in humans, we conducted a randomized, double-blind, placebo-controlled pilot study in overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial. The primary end points were safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass). Secondary outcomes were gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition. In this single-center study, we demonstrated that daily oral supplementation of 10 10 A. muciniphila bacteria either live or pasteurized for three months was safe and well tolerated. Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02). Pasteurized A. muciniphila supplementation slightly decreased body weight (-2.27 ± 0.92 kg, P = 0.091) compared to the placebo group, and fat mass (-1.37 ± 0.82 kg, P = 0.092) and hip circumference (-2.63 ± 1.14 cm, P = 0.091) compared to baseline. After three months of supplementation, A. muciniphila reduced the levels of the relevant blood markers for liver dysfunction and inflammation while the overall gut microbiome structure was unaffected. In conclusion, this proof-of-concept study (clinical trial no. NCT02637115 ) shows that the intervention was safe and well tolerated and that supplementation with A. muciniphila improves several metabolic parameters.",2019,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","['overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial', 'overweight and obese human volunteers']","['placebo', 'Akkermansia muciniphila']","['safe and well tolerated', 'insulin sensitivity', 'reduced insulinemia', 'several metabolic parameters', 'body weight', 'fat mass', 'gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition', 'hip circumference', 'safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass', 'levels of the relevant blood markers for liver dysfunction and inflammation', 'plasma total cholesterol']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",40.0,0.293433,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Depommier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Everard', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Druart', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Plovier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Van Hul', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vieira-Silva', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Falony', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Raes', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Maiter', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Barsy', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Loumaye', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Michel P', 'Initials': 'MP', 'LastName': 'Hermans', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Thissen', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'de Vos', 'Affiliation': 'Laboratory of Microbiology, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Patrice D', 'Initials': 'PD', 'LastName': 'Cani', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium. Patrice.cani@uclouvain.be.'}]",Nature medicine,['10.1038/s41591-019-0495-2']
845,31378435,The Finnish Randomized Trial of Adjuvant Radiotherapy Versus Observation After Prostatectomy: Almost a Trial of Adjuvant Versus Late Salvage Radiotherapy.,,2019,,[],"['Adjuvant Radiotherapy Versus Observation', 'Adjuvant Versus Late Salvage Radiotherapy']",[],[],"[{'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],,0.0356717,,"[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA. Electronic address: sprattda@med.umich.edu.'}]",European urology,['10.1016/j.eururo.2019.07.036']
846,30870563,Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial.,"Importance
High-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently.
Objective
To examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes.
Design, Setting, and Participants
A cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat.
Interventions
Tools, training, and system changes.
Main Outcomes and Measures
The coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated.
Results
Data from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups.
Conclusions and Relevance
The results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study.
Trial Registration
ClinicalTrials.gov identifier: NCT01786811.",2019,"Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31).","['Patients with advanced cancer (n\u2009=\u2009278) and oncology clinicians (n\u2009=\u200991) participated between September 1, 2012, and June 30, 2016', 'Outpatient Oncology']","['communication quality-improvement intervention (Serious Illness Care Program', 'Serious Illness Care Program']","['severe anxiety', 'Survival and therapeutic alliance', 'therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival', 'Peacefulness, therapeutic alliance, anxiety, and depression', 'depression symptoms', 'Anxiety reduction', 'anxiety and depression', 'goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire', 'depression reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic) (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",64.0,0.109751,"Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31).","[{'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Hutchings', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Olaf P', 'Initials': 'OP', 'LastName': 'Geerse', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Lakin', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Sanders', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lipsitz', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Atul A', 'Initials': 'AA', 'LastName': 'Gawande', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Block', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0077']
847,30892564,Effectiveness of Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Acrophobia: A Randomized Clinical Trial.,"Importance
Globally, access to evidence-based psychological treatment is limited. Innovative self-help methods using smartphone applications and low-cost virtual reality have the potential to significantly improve the accessibility and scalability of psychological treatments.
Objective
To examine the effectiveness of ZeroPhobia, a fully self-guided app-based virtual reality cognitive behavior therapy (VR CBT) using low-cost (cardboard) virtual reality goggles compared with a wait-list control group and to determine its user friendliness.
Design, Setting, and Participants
In a single-blind randomized clinical trial, participants were enrolled between March 24 and September 28, 2017, and randomly assigned (1:1) by an independent researcher to either VR CBT app or a wait-list control group. A total of 193 individuals aged 18 to 65 years from the Dutch general population with acrophobia symptoms and access to an Android smartphone participated. The 6 animated modules of the VR-CBT app and gamified virtual reality environments were delivered over a 3-week period in participants' natural environment. Assessments were completed at baseline, immediately after treatment, and at 3-month follow-up. Analysis began April 6, 2018, and was intention to treat.
Intervention
Self-guided app-based VR CBT.
Main Outcomes and Measures
The primary outcome measure was the Acrophobia Questionnaire. The hypothesis was formulated prior to data collection.
Results
In total, 193 participants (129 women [66.84%]; mean [SD] age, 41.33 [13.64] years) were randomly assigned to intervention (n = 96) or a wait-list control group (n = 97). An intent-to-treat analysis showed a significant reduction of acrophobia symptoms at posttest at 3 months for the VR-CBT app compared with the controls (b = -26.73 [95% CI, -32.12 to -21.34]; P < .001; d = 1.14 [95% CI, 0.84 to 1.44]). The number needed to treat was 1.7. Sensitivity and robustness analysis confirmed these findings. Pretreatment attrition was 22 of 96 (23%) because of smartphone incompatibility. Of the 74 participants who started using the VR-CBT app, 57 (77%) completed the intervention fully.
Conclusions and Relevance
A low-cost fully self-guided app-based virtual reality cognitive behavioral therapy with rudimentary virtual reality goggles can produce large acrophobia symptom reductions. To our knowledge, this study is the first to show that virtual reality acrophobia treatment can be done at home without the intervention of a therapist.
Trial Registration
Trialregister.nl identifier: NTR6442.",2019,"An intent-to-treat analysis showed a significant reduction of acrophobia symptoms at posttest at 3 months for the VR-CBT app compared with the controls (b = -26.73 [95% CI, -32.12 to -21.34]; P < .001; d = 1.14 [95% CI, 0.84 to 1.44]).","['193 participants (129 women [66.84%]; mean [SD] age,\u200941.33 [13.64] years', '193 individuals aged 18 to 65 years from the Dutch general population with acrophobia symptoms and access to an Android smartphone participated', '74 participants who started using the VR-CBT app, 57 (77%) completed the intervention fully', 'Acrophobia', 'participants were enrolled between March 24 and September 28, 2017, and randomly assigned (1:1) by an independent researcher to either']","['VR CBT app or a wait-list control group', 'Self-guided App-Based Virtual Reality Cognitive Behavior Therapy', 'wait-list control group', 'Intervention\n\n\nSelf-guided app-based VR CBT', 'ZeroPhobia, a fully self-guided app-based virtual reality cognitive behavior therapy (VR CBT) using low-cost (cardboard) virtual reality goggles']","['Pretreatment attrition', 'Acrophobia Questionnaire', 'acrophobia symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0233701', 'cui_str': 'Fear of heights (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0718532', 'cui_str': 'Android'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018020', 'cui_str': 'Goggles'}]","[{'cui': 'C0233701', 'cui_str': 'Fear of heights (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",193.0,0.0841422,"An intent-to-treat analysis showed a significant reduction of acrophobia symptoms at posttest at 3 months for the VR-CBT app compared with the controls (b = -26.73 [95% CI, -32.12 to -21.34]; P < .001; d = 1.14 [95% CI, 0.84 to 1.44]).","[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Donker', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Section Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ilja', 'Initials': 'I', 'LastName': 'Cornelisz', 'Affiliation': 'Department of Education Sciences, Section Methods and Statistics, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'van Klaveren', 'Affiliation': 'Department of Education Sciences, Section Methods and Statistics, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Section Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, University Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Section Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'van Gelder', 'Affiliation': 'Department of Psychology of Conflict, Risk and Safety, University of Twente, Enschede, Amsterdam, the Netherlands.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.0219']
848,30774069,"Ten-year follow-up of a randomised trial of drainage, irrigation and fibrinolytic therapy (DRIFT) in infants with post-haemorrhagic ventricular dilatation.","BACKGROUND
The drainage, irrigation and fibrinolytic therapy (DRIFT) trial, conducted in 2003-6, showed a reduced rate of death or severe disability at 2 years in the DRIFT compared with the standard treatment group, among preterm infants with intraventricular haemorrhage (IVH) and post-haemorrhagic ventricular dilatation.
OBJECTIVES
To compare cognitive function, visual and sensorimotor ability, emotional well-being, use of specialist health/rehabilitative and educational services, neuroimaging, and economic costs and benefits at school age.
DESIGN
Ten-year follow-up of a randomised controlled trial.
SETTING
Neonatal intensive care units (Bristol, Katowice, Glasgow and Bergen).
PARTICIPANTS
Fifty-two of the original 77 infants randomised.
INTERVENTIONS
DRIFT or standard therapy (cerebrospinal fluid tapping).
MAIN OUTCOME MEASURES
Primary - cognitive disability. Secondary - vision; sensorimotor disability; emotional/behavioural function; education; neurosurgical sequelae on magnetic resonance imaging; preference-based measures of health-related quality of life; costs of neonatal treatment and of subsequent health care in childhood; health and social care costs and impact on family at age 10 years; and a decision analysis model to estimate the cost-effectiveness of DRIFT compared with standard treatment up to the age of 18 years.
RESULTS
By 10 years of age, 12 children had died and 13 were either lost to follow-up or had declined to participate. A total of 52 children were assessed at 10 years of age (DRIFT, n = 28; standard treatment, n = 24). Imbalances in gender and birthweight favoured the standard treatment group. The unadjusted mean cognitive quotient (CQ) score was 69.3 points [standard deviation (SD) 30.1 points] in the DRIFT group compared with 53.7 points (SD 35.7 points) in the standard treatment group, a difference of 15.7 points, 95% confidence interval (CI) -2.9 to 34.2 points; p = 0.096. After adjusting for the prespecified covariates (gender, birthweight and grade of IVH), this evidence strengthened: children who received DRIFT had a CQ advantage of 23.5 points ( p = 0.009). The binary outcome, alive without severe cognitive disability, gave strong evidence that DRIFT improved cognition [unadjusted odds ratio (OR) 3.6 (95% CI 1.2 to 11.0; p = 0.026) and adjusted OR 10.0 (95% CI 2.1 to 46.7; p = 0.004)]; the number needed to treat was three. No significant differences were found in any secondary outcomes. There was weak evidence that DRIFT reduced special school attendance (adjusted OR 0.27, 95% CI 0.07 to 1.05; p = 0.059). The neonatal stay (unadjusted mean difference £6556, 95% CI -£11,161 to £24,273) and subsequent hospital care (£3413, 95% CI -£12,408 to £19,234) costs were higher in the DRIFT arm, but the wide CIs included zero. The decision analysis model indicated that DRIFT has the potential to be cost-effective at 18 years of age. The incremental cost-effectiveness ratio (£15,621 per quality-adjusted life-year) was below the National Institute for Health and Care Excellence threshold. The cost-effectiveness results were sensitive to adjustment for birthweight and gender.
LIMITATIONS
The main limitations are the sample size of the trial and that important characteristics were unbalanced at baseline and at the 10-year follow-up. Although the analyses conducted here were prespecified in the analysis plan, they had not been prespecified in the original trial registration.
CONCLUSIONS
DRIFT improves cognitive function when taking into account birthweight, grade of IVH and gender. DRIFT is probably effective and, given the reduction in the need for special education, has the potential to be cost-effective as well. A future UK multicentre trial is required to assess efficacy and safety of DRIFT when delivered across multiple sites.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN80286058.
FUNDING
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 4. See the NIHR Journals Library website for further project information. The DRIFT trial and 2-year follow-up was funded by Cerebra and the James and Grace Anderson Trust.",2019,"There was weak evidence that DRIFT reduced special school attendance (adjusted OR 0.27, 95% CI 0.07 to 1.05; p = 0.059).","['Fifty-two of the original 77 infants randomised', 'infants with post-haemorrhagic ventricular dilatation', '52 children were assessed at 10 years of age (DRIFT, n \u2009=\u200928; standard treatment, n \u2009=\u200924', 'Neonatal intensive care units (Bristol, Katowice, Glasgow and Bergen', 'preterm infants with intraventricular haemorrhage (IVH) and post-haemorrhagic ventricular dilatation', 'By 10 years of age, 12 children had died and 13 were either lost to follow-up or had declined to participate']","['drainage, irrigation and fibrinolytic therapy (DRIFT', 'DRIFT or standard therapy (cerebrospinal fluid tapping']","['cognitive function', 'special school attendance', 'incremental cost-effectiveness ratio', 'cognitive function, visual and sensorimotor ability, emotional well-being, use of specialist health/rehabilitative and educational services, neuroimaging, and economic costs and benefits at school age', 'cognitive disability', 'neonatal stay', 'rate of death or severe disability', 'cost-effectiveness', 'unadjusted mean cognitive quotient (CQ) score', 'alive without severe cognitive disability', 'subsequent hospital care']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0264733', 'cui_str': 'Ventricular dilatation (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0040044', 'cui_str': 'Thrombolysis, Therapeutic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0007807'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0010187', 'cui_str': 'Cost Benefit'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",52.0,0.174903,"There was weak evidence that DRIFT reduced special school attendance (adjusted OR 0.27, 95% CI 0.07 to 1.05; p = 0.059).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Luyt', 'Affiliation': 'Neonatal Neurology, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Jary', 'Affiliation': 'Neonatal Neurology, University of Bristol, Bristol, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lea', 'Affiliation': 'Neonatal Neurology, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Odd', 'Affiliation': 'Neonatal Neurology, University of Bristol, Bristol, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Miller', 'Affiliation': 'Neonatal Neurology, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Kmita', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Paediatric Ophthalmology, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.'}, {'ForeName': 'Aída Moure', 'Initials': 'AM', 'LastName': 'Fernández', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': ""Department of Psychology, Community Children's Health Partnership, Bristol, UK.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Smith-Collins', 'Affiliation': 'Neonatal Neurology, University of Bristol, Bristol, UK.'}, {'ForeName': 'N Jade', 'Initials': 'NJ', 'LastName': 'Thai', 'Affiliation': 'Clinical Research and Imaging Centre, Bristol, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Walker-Cox', 'Affiliation': 'Neonatal Neurology, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Aquilina', 'Affiliation': 'Paediatric Neurosurgery, Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pople', 'Affiliation': 'Paediatric Neurosurgery, University Hospitals Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whitelaw', 'Affiliation': 'Neonatal Neurology, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23040']
849,30477000,Economic Evaluation of Talimogene Laherparepvec Plus Ipilimumab Combination Therapy vs Ipilimumab Monotherapy in Patients With Advanced Unresectable Melanoma.,"Importance
A phase 2 trial comparing talimogene laherparepvec plus ipilimumab vs ipilimumab monotherapy in patients with advanced unresectable melanoma found no differential benefit in progression-free survival (PFS) but noted objective response rates (ORRs) of 38.8% (38 of 98 patients) vs 18.0% (18 of 100 patients), respectively.
Objective
To perform an economic evaluation of talimogene laherparepvec plus ipilimumab combination therapy vs ipilimumab monotherapy.
Design, Setting, and Participants
For PFS, cost-effectiveness and cost-utility analyses using a 2-state Markov model (PFS vs progression or death) was performed. For ORRs, cost-effectiveness analysis of the incremental cost of 1 additional patient achieving objective response was performed. In this setting based on a US payer perspective (2017 US dollars), participants were patients with advanced unresectable melanoma.
Main Outcomes and Measures
The PFS life-years and PFS quality-adjusted life-years were determined, and the associated incremental cost-effectiveness ratios (ICERs) and incremental cost-utility ratios (ICURs) were estimated. Also estimated was the ICER per 1 additional patient (out of 100 treated patients) achieving objective response. Base-case analyses were validated by sensitivity analyses.
Results
In PFS analyses, the cost of talimogene laherparepvec plus ipilimumab ($494 983) exceeded the cost of ipilimumab monotherapy ($132 950) by $362 033. The ICER was $2 129 606 per PFS life-years, and the ICUR was $2 262 706 per PFS quality-adjusted life-year gained. Probabilistic sensitivity analyses yielded an ICER of $1 481 208 per PFS life-year gained and an ICUR of $1 683 191 per PFS quality-adjusted life-year gained. In 1-way sensitivity analyses, the PFS hazard ratio and the utility of response were the most influential parameters. Talimogene laherparepvec plus ipilimumab has a 50% likelihood of being cost-effective at a willingness-to-pay threshold of $1 683 191 per PFS quality-adjusted life-year gained. In ORR analyses, talimogene laherparepvec plus ipilimumab ($474 904) vs ipilimumab alone ($132 810), a $342 094 difference, yielded an ICER of $1 629 019 per additional patient achieving objective response. In subgroup analyses by disease stage and BRAFV600E mutation status, ICERs ranged from $1 069 044 to $17 104 700 per 1 additional patient achieving objective response.
Conclusions and Relevance
The cost to gain 1 additional progression-free quality-adjusted life-year, 1 additional progression-free life-year, or to have 1 additional patient attain objective response is about $1.6 million. This amount may be beyond what payers typically are willing to pay. Combination therapy of talimogene laherparepvec plus ipilimumab does not offer an economically beneficial treatment option relative to ipilimumab monotherapy at the population level. This should not preclude treatment for individual patients for whom this regimen may be indicated.",2019,Combination therapy of talimogene laherparepvec plus ipilimumab does not offer an economically beneficial treatment option relative to ipilimumab monotherapy at the population level.,"['patients with advanced unresectable melanoma', 'Patients With Advanced Unresectable Melanoma', 'participants were patients with advanced unresectable melanoma']","['Talimogene Laherparepvec Plus Ipilimumab Combination Therapy vs Ipilimumab Monotherapy', 'Talimogene laherparepvec plus ipilimumab', 'talimogene laherparepvec plus ipilimumab vs ipilimumab monotherapy']","['PFS hazard ratio and the utility of response', 'PFS life-years and PFS quality-adjusted life-years', 'incremental cost-effectiveness ratios (ICERs) and incremental cost-utility ratios (ICURs', 'progression-free survival (PFS', 'objective response', 'ICER']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C1831828', 'cui_str': 'TALIMOGENE LAHERPAREPVEC'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",100.0,0.144932,Combination therapy of talimogene laherparepvec plus ipilimumab does not offer an economically beneficial treatment option relative to ipilimumab monotherapy at the population level.,"[{'ForeName': 'Abdulaali R', 'Initials': 'AR', 'LastName': 'Almutairi', 'Affiliation': 'Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, The University of Arizona, Tucson.'}, {'ForeName': 'Nimer S', 'Initials': 'NS', 'LastName': 'Alkhatib', 'Affiliation': 'Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, The University of Arizona, Tucson.'}, {'ForeName': 'Mok', 'Initials': 'M', 'LastName': 'Oh', 'Affiliation': 'Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, The University of Arizona, Tucson.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Curiel-Lewandrowski', 'Affiliation': 'Division of Dermatology, Department of Medicine, College of Medicine, The University of Arizona, Tucson.'}, {'ForeName': 'Hani M', 'Initials': 'HM', 'LastName': 'Babiker', 'Affiliation': 'The University of Arizona Cancer Center, Tucson.'}, {'ForeName': 'Lee D', 'Initials': 'LD', 'LastName': 'Cranmer', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'McBride', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, The University of Arizona, Tucson.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Abraham', 'Affiliation': 'Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, The University of Arizona, Tucson.'}]",JAMA dermatology,['10.1001/jamadermatol.2018.3958']
850,29558241,Frontal lesions predict response to prism adaptation treatment in spatial neglect: A randomised controlled study.,"Spatial neglect commonly follows right hemisphere stroke. It is defined as impaired contralesional stimulus detection, response, or action, causing functional disability. While prism adaptation treatment is highly promising to promote functional recovery of spatial neglect, not all individuals respond. Consistent with a primary effect of prism adaptation on spatial movements, we previously demonstrated that functional improvement after prism adaptation treatment is linked to frontal lobe lesions. However, that study was a treatment-only study with no randomised control group. The current study randomised individuals with spatial neglect to receive 10 days of prism adaptation treatment or to receive only standard care (control group). Replicating our earlier results, we found that the presence of frontal lesions moderated response to prism adaptation treatment: among prism-treated patients, only those with frontal lesions demonstrated functional improvements in their neglect symptoms. Conversely, among individuals in the standard care control group, the presence of frontal lesions did not modify recovery. These results suggest that further research is needed on how frontal lesions may predict response to prism adaptation treatment. Additionally, the results help elucidate the neural network involved in spatial movement and could be used to aid decisions about treatment.",2020,"Conversely, among individuals in the standard care control group, the presence of frontal lesions did not modify recovery.",['spatial neglect'],['prism adaptation treatment or to receive only standard care (control group'],[],"[{'cui': 'C0521874', 'cui_str': 'Victim of neglect'}]","[{'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0234771,"Conversely, among individuals in the standard care control group, the presence of frontal lesions did not modify recovery.","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Goedert', 'Affiliation': 'Department of Psychology, Seton Hall University, South Orange, NJ, USA.'}, {'ForeName': 'Peii', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Stroke Rehabilitation Research, Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Foundas', 'Affiliation': 'Department of Psychology, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Barrett', 'Affiliation': 'Stroke Rehabilitation Research, Kessler Foundation, West Orange, NJ, USA.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2018.1448287']
851,30347019,Alisertib in Combination With Weekly Paclitaxel in Patients With Advanced Breast Cancer or Recurrent Ovarian Cancer: A Randomized Clinical Trial.,"Importance
There is an unmet medical need for the treatment of recurrent ovarian cancer, and new approaches are needed to improve progression-free survival (PFS) and overall survival.
Objective
This phase 1/2 study evaluated the activity of alisertib in combination with weekly paclitaxel in patients with breast (phase 1) and ovarian cancer (phase 1 and phase 2).
Design, Setting, and Participants
An open-label phase 1 and randomized phase 2 clinical trial conducted from April 16, 2010, for phase 1 and March 28, 2012, to August 12, 2013, for phase 2 was conducted at 33 sites (United States, France, and Poland). Data are reported from a cutoff date of August 12, 2014, with a median duration of follow-up of 7.2 months in the alisertib plus paclitaxel arm and 4.6 months in the paclitaxel arm. A total of 191 women with advanced breast (phase 1 only) or recurrent ovarian cancer were enrolled, including 142 patients randomized to alisertib plus paclitaxel (n = 73) or paclitaxel alone (n = 69) in the phase 2 study.
Interventions
Patients were randomized 1:1 stratified by platinum-free interval (refractory, 0-6 months, 6-12 months) and prior weekly taxane treatment (yes, no) to receive alisertib 40 mg twice per day orally and 3 days on and 4 days off for 3 weeks, plus paclitaxel (60 mg/m2 intravenously, days 1, 8, and 15), or weekly paclitaxel 80 mg/m2 intravenously in 28-day cycles.
Main Outcomes and Measures
Primary endpoint was PFS; primary efficacy analysis and safety analysis used modified intention to treat (mITT) population (all randomized patients who received ≥1 dose of study drug).
Results
The median age for the 191 patients enrolled in phase 1 was 59 (range, 29-75) years. The median age for the 142 patients enrolled in phase 2 was 63 (range, 30-81) years for patients receiving alisertib plus paclitaxel and 61 (range, 41-81) years for patients receiving paclitaxel. At data cutoff, 107 (75%) patients had a documented PFS event; 52 (71%) in the alisertib plus paclitaxel arm, and 55 (80%) in the paclitaxel arm. Median PFS was 6.7 months with alisertib plus paclitaxel vs 4.7 months with paclitaxel (HR, 0.75; 80% CI, 0.58-0.96; P = .14; 2-sided P value cutoff = .20 to be considered worthy of further investigation). Drug-related grade 3 or higher adverse events were reported in 63 (86%) vs 14 (20%) patients in the alisertib plus paclitaxel and paclitaxel arms, including 56 (77%) vs 7 (10%) neutropenia, 18 (25%) vs 0 stomatitis, and 10 (14%) vs 2 (3%) anemia; 54 (74%) vs 17 (25%) had adverse events leading to dose reductions. Two patients died during the study (1 in each arm); neither death was considered related to study drug.
Conclusions and Relevance
The primary endpoint, PFS, significantly favored alisertib plus paclitaxel over paclitaxel alone. Further investigation is warranted.
Trial Registration
ClinicalTrials.gov identifier: NCT01091428.",2019,"Drug-related grade 3 or higher adverse events were reported in 63 (86%) vs 14 (20%) patients in the alisertib plus paclitaxel and paclitaxel arms, including 56 (77%) vs 7 (10%) neutropenia, 18 (25%) vs 0 stomatitis, and 10 (14%) vs 2 (3%) anemia; 54 (74%) vs 17 (25%) had adverse events leading to dose reductions.","['142 patients enrolled in phase 2 was 63 (range, 30-81) years for patients receiving alisertib plus paclitaxel and 61 (range, 41-81) years for patients receiving', 'Patients With Advanced Breast Cancer or Recurrent Ovarian Cancer', '191 patients enrolled in phase 1 was 59 (range, 29-75) years', 'Participants\n\n\nAn open-label phase 1 and randomized phase 2 clinical trial conducted from April 16, 2010, for phase 1 and March 28, 2012, to August 12, 2013, for phase 2 was conducted at 33 sites (United States, France, and Poland', 'patients with breast (phase 1) and ovarian cancer (phase 1 and phase 2', '191 women with advanced breast (phase 1 only) or recurrent ovarian cancer were enrolled, including 142 patients randomized to']","['paclitaxel 80 mg/m2 intravenously in 28-day cycles', 'Alisertib in Combination With Weekly Paclitaxel', 'paclitaxel', 'paclitaxel alone', 'alisertib plus paclitaxel', 'platinum-free interval (refractory, 0-6 months, 6-12 months) and prior weekly taxane treatment (yes, no) to receive alisertib']","['progression-free survival (PFS) and overall survival', 'death', 'adverse events', 'PFS; primary efficacy analysis and safety analysis used modified intention to treat (mITT) population', 'neutropenia', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2987636'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1096779', 'cui_str': 'Clinical Trial, Phase 2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2987636'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1298907', 'cui_str': 'Yes'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",191.0,0.184268,"Drug-related grade 3 or higher adverse events were reported in 63 (86%) vs 14 (20%) patients in the alisertib plus paclitaxel and paclitaxel arms, including 56 (77%) vs 7 (10%) neutropenia, 18 (25%) vs 0 stomatitis, and 10 (14%) vs 2 (3%) anemia; 54 (74%) vs 17 (25%) had adverse events leading to dose reductions.","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Falchook', 'Affiliation': 'Sarah Cannon Research Institute at HealthONE, Denver, Colorado.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'University of Texas, MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Roszak', 'Affiliation': 'Greater Poland Cancer Centre/University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Behbakht', 'Affiliation': 'Department of Gynecologic Oncology, University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Matulonis', 'Affiliation': 'Gynecologic Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Centre Léon Bérard & University Claude Bernard, Lyon, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Sawrycki', 'Affiliation': 'Department of Oncology and Chemotherapy, L. Rydygiera District Hospital, Torun, Poland.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'University of Virginia Health System, Charlottesville.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tew', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Sharad', 'Initials': 'S', 'LastName': 'Ghamande', 'Affiliation': 'Georgia Cancer Center at Augusta University, Augusta, Georgia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lesoin', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Schwartz', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Buscema', 'Affiliation': 'Arizona Oncology Associates PC, Tucson, Arizona.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Fabbro', 'Affiliation': 'Institut Regional du Cancer, Montpellier, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lortholary', 'Affiliation': 'Centre Catherine de Sienne, Nantes, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Goff', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Razelle', 'Initials': 'R', 'LastName': 'Kurzrock', 'Affiliation': 'San Diego Moores Cancer Center, La Jolla, California.'}, {'ForeName': 'Lainie P', 'Initials': 'LP', 'LastName': 'Martin', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Gray', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'University of Texas, MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sheldon-Waniga', 'Affiliation': 'Millennium Pharmaceuticals Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, Massachusetts.'}, {'ForeName': 'Huamao Mark', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, Massachusetts.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, Massachusetts.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Millennium Pharmaceuticals Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, Massachusetts.'}, {'ForeName': 'E Jane', 'Initials': 'EJ', 'LastName': 'Leonard', 'Affiliation': 'Millennium Pharmaceuticals Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, Massachusetts.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schilder', 'Affiliation': 'Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania.'}]",JAMA oncology,['10.1001/jamaoncol.2018.3773']
852,32144015,Snodgrass vs Snodgraft operation to repair the distal hypospadias in the narrow urethral plate.,"BACKGROUND
Using the Snodgraft technique in patients with urethral plate less than 8 mm to repair distal hypospadias is still debatable. Some authors assume that augmentation may be beneficial. We aimed to compare the outcomes of the Snodgrass vs Snodgraft procedure in patients with a narrow urethral plate less than 8 mm.
METHODOLOGY
This prospective randomized study included 60 children who had been treated by the Snodgrass or Snodgraft procedure for repair of distal penile hypospadias with narrow urethral plate from March 2017 to September 2018. They were randomized into two subgroups. Group 1 (30 patients) underwent tubularized incised plate urethroplasty, whereas the second group (30 patients) underwent the Snodgraft procedure by using the inner prepuce. Operative details, postoperative period, and complications were reported and statistically analyzed using IBM SPSS software package version 20.0.
RESULTS
The operative time was longer for patients who underwent the Snodgraft procedure: 78 (55-95) and 110 (80-140) minutes in groups 1 and 2, respectively. In group 1, there was one case of meatal stenosis which was resolved by urethral dilation using the local anesthetic cream in the outpatient clinic. In addition, there was another case of distal penile fistula. In group 2, there was a case of complete wound disruption and another of distal penile fistula. There was no significant difference in the complication rate in any group.
CONCLUSION
The operative time was longer in group 2 than in group 1 but with comparable outcomes. The Snodgraft procedure is not superior to the Snodgrass operation in the narrow healthy urethral plate.",2020,The operative time was longer in group 2 than in group 1 but with comparable outcomes.,"['patients with urethral plate less than 8\xa0mm to repair distal hypospadias', '60 children who had been treated by the Snodgrass or Snodgraft procedure for repair of distal penile hypospadias with narrow urethral plate from March 2017 to September 2018', 'patients with a narrow urethral plate less than 8\xa0mm']",['Snodgrass vs Snodgraft procedure'],"['complete wound disruption and another of distal penile fistula', 'operative time', 'Operative details, postoperative period, and complications', 'distal penile fistula', 'complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0440785', 'cui_str': 'Urethral plate (substance)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3839553', 'cui_str': 'Distal penile hypospadias (disorder)'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",60.0,0.0213677,The operative time was longer in group 2 than in group 1 but with comparable outcomes.,"[{'ForeName': 'Mosaab', 'Initials': 'M', 'LastName': 'Eldeeb', 'Affiliation': 'Urology Department, Tanta University, Egypt.'}, {'ForeName': 'Salah', 'Initials': 'S', 'LastName': 'Nagla', 'Affiliation': 'Urology Department, Tanta University, Egypt. Electronic address: salahnaglah@yahoo.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abou-Farha', 'Affiliation': 'Urology Department, Tanta University, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Urology Department, Tanta University, Egypt.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.01.006']
853,31709970,"Glycaemic, gastrointestinal, hormonal and appetitive responses to pearl millet or oats porridge breakfasts: a randomised, crossover trial in healthy humans.","Whole-grain cereal breakfast consumption has been associated with beneficial effects on glucose and insulin metabolism as well as satiety. Pearl millet is a popular ancient grain variety that can be grown in hot, dry regions. However, little is known about its health effects. The present study investigated the effect of a pearl millet porridge (PMP) compared with a well-known Scottish oats porridge (SOP) on glycaemic, gastrointestinal, hormonal and appetitive responses. In a randomised, two-way crossover trial, twenty-six healthy participants consumed two isoenergetic/isovolumetric PMP or SOP breakfast meals, served with a drink of water. Blood samples for glucose, insulin, glucagon-like peptide 1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY, gastric volumes and appetite ratings were collected 2 h postprandially, followed by an ad libitum meal and food intake records for the remainder of the day. The incremental AUC (iAUC2h) for blood glucose was not significantly different between the porridges (P > 0·05). The iAUC2h for gastric volume was larger for PMP compared with SOP (P = 0·045). The iAUC2h for GIP concentration was significantly lower for PMP compared with SOP (P = 0·001). Other hormones and appetite responses were similar between meals. In conclusion, the present study reports, for the first time, data on glycaemic and physiological responses to a pearl millet breakfast, showing that this ancient grain could represent a sustainable alternative with health-promoting characteristics comparable with oats. GIP is an incretin hormone linked to TAG absorption in adipose tissue; therefore, the lower GIP response for PMP may be an added health benefit.",2019,The iAUC2h for gastric volume was larger for PMP compared with SOP (P = 0·045).,"['twenty-six healthy participants consumed two isoenergetic/isovolumetric PMP or SOP breakfast meals, served with a drink of water', 'healthy humans']","['pearl millet porridge (PMP', 'pearl millet or oats porridge breakfasts', 'well-known Scottish oats porridge (SOP']","['GIP concentration', 'Blood samples for glucose, insulin, glucagon-like peptide 1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY, gastric volumes and appetite ratings', 'glycaemic, gastrointestinal, hormonal and appetitive responses', 'incremental AUC (iAUC2h) for blood glucose', 'Glycaemic, gastrointestinal, hormonal and appetitive responses']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0331550', 'cui_str': 'Millet, Pearl'}, {'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",26.0,0.111805,The iAUC2h for gastric volume was larger for PMP compared with SOP (P = 0·045).,"[{'ForeName': 'Jaber', 'Initials': 'J', 'LastName': 'Alyami', 'Affiliation': 'Department of Diagnostic Radiology, Faculty of Applied Medical Science, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Whitehouse', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Gleb E', 'Initials': 'GE', 'LastName': 'Yakubov', 'Affiliation': 'Division of Food, Nutrition and Dietetics, School of Biosciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Pritchard', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Hoad', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Blackshaw', 'Affiliation': 'Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Heissam', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Cordon', 'Affiliation': 'School of Life Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'H Frances J', 'Initials': 'HFJ', 'LastName': 'Bligh', 'Affiliation': 'Unilever R&D, Colworth Science Park, Sharnbrook, Bedfordshire, UK.'}, {'ForeName': 'Robin C', 'Initials': 'RC', 'LastName': 'Spiller', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Guruprasad P', 'Initials': 'GP', 'LastName': 'Aithal', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Penny A', 'Initials': 'PA', 'LastName': 'Gowland', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Moira A', 'Initials': 'MA', 'LastName': 'Taylor', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marciani', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, UK.'}]",The British journal of nutrition,['10.1017/S0007114519001880']
854,30370983,Lack of Target Engagement Following Low-Frequency Deep Transcranial Magnetic Stimulation of the Anterior Insula.,"OBJECTIVE
To evaluate the safety and efficacy of low-frequency, inhibitory, deep rTMS with a novel H-coil specifically designed to stimulate the insula.
METHODS
In a randomized, crossover order, 16 healthy volunteers underwent two sessions (sham; active) of 1 Hz repetitive TMS at an intensity of 120% of individual motor threshold, over the right anterior insular cortex localized using a neuronavigation system. Before, immediately after, and one hour after rTMS, subjects performed two tasks that have previously been shown in fMRI experiments to activate insular cortex: A blink suppression task and a forced-choice risk-taking task.
RESULTS
No drop-outs or adverse events occurred. Active deep rTMS did not result in decreased urge to blink compared to sham. Similarly, no significant time × condition interaction on risk-taking behavior was found.
CONCLUSIONS
Low-frequency deep rTMS using a novel H8 coil was shown to be safe but did not affect any of the behavioral markers, also used to investigate modulation of insula activity. Our findings highlight the challenges of modulating the activity of deep brain regions with TMS. Further studies are necessary to identify effective stimulation parameters for deep targets, and to characterize the effects of deep TMS on overlying cortical regions.",2019,"deep rTMS using a novel H8 coil was shown to be safe but did not affect any of the behavioral markers, also used to investigate modulation of insula activity.",['16 healthy volunteers underwent'],['two sessions (sham; active) of 1 Hz repetitive TMS'],"['risk-taking behavior', 'safety and efficacy', 'urge to blink', 'drop-outs or adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",16.0,0.0168752,"deep rTMS using a novel H8 coil was shown to be safe but did not affect any of the behavioral markers, also used to investigate modulation of insula activity.","[{'ForeName': 'Primavera A', 'Initials': 'PA', 'LastName': 'Spagnolo', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Prachaya', 'Initials': 'P', 'LastName': 'Srivanitchapoom', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, IKE, Linkoping University, Linkoping, Sweden.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.12875']
855,31322116,Tranexamic acid to improve functional status in adults with spontaneous intracerebral haemorrhage: the TICH-2 RCT.,"BACKGROUND
Tranexamic acid reduces death due to bleeding after trauma and postpartum haemorrhage.
OBJECTIVE
The aim of the study was to assess if tranexamic acid is safe, reduces haematoma expansion and improves outcomes in adults with spontaneous intracerebral haemorrhage (ICH).
DESIGN
The TICH-2 (Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage) study was a pragmatic, Phase III, prospective, double-blind, randomised placebo-controlled trial.
SETTING
Acute stroke services at 124 hospitals in 12 countries (Denmark, Georgia, Hungary, Ireland, Italy, Malaysia, Poland, Spain, Sweden, Switzerland, Turkey and the UK).
PARTICIPANTS
Adult patients (aged ≥ 18 years) with ICH within 8 hours of onset.
EXCLUSION CRITERIA
Exclusion criteria were ICH secondary to anticoagulation, thrombolysis, trauma or a known underlying structural abnormality; patients for whom tranexamic acid was thought to be contraindicated; prestroke dependence (i.e. patients with a modified Rankin Scale [mRS] score > 4); life expectancy < 3 months; and a Glasgow Coma Scale score of < 5.
INTERVENTIONS
Participants, allocated by randomisation, received 1 g of an intravenous tranexamic acid bolus followed by an 8-hour 1-g infusion or matching placebo (i.e. 0.9% saline).
MAIN OUTCOME MEASURE
The primary outcome was functional status (death or dependency) at day 90, which was measured by the shift in the mRS score, using ordinal logistic regression, with adjustment for stratification and minimisation criteria.
RESULTS
A total of 2325 participants (tranexamic acid, n = 1161; placebo, n = 1164) were recruited from 124 hospitals in 12 countries between 2013 and 2017. Treatment groups were well balanced at baseline. The primary outcome was determined for 2307 participants (tranexamic acid, n = 1152; placebo, n = 1155). There was no statistically significant difference between the treatment groups for the primary outcome of functional status at day 90 [adjusted odds ratio (aOR) 0.88, 95% confidence interval (CI) 0.76 to 1.03; p = 0.11]. Although there were fewer deaths by day 7 in the tranexamic acid group (aOR 0.73, 95% CI 0.53 to 0.99; p = 0.041), there was no difference in case fatality at 90 days (adjusted hazard ratio 0.92, 95% CI 0.77 to 1.10; p = 0.37). Fewer patients experienced serious adverse events (SAEs) after treatment with tranexamic acid than with placebo by days 2 ( p = 0.027), 7 ( p = 0.020) and 90 ( p = 0.039). There was no increase in thromboembolic events or seizures.
LIMITATIONS
Despite attempts to enrol patients rapidly, the majority of participants were enrolled and treated > 4.5 hours after stroke onset. Pragmatic inclusion criteria led to a heterogeneous population of participants, some of whom had very large strokes. Although 12 countries enrolled participants, the majority (82.1%) were from the UK.
CONCLUSIONS
Tranexamic acid did not affect a patient's functional status at 90 days after ICH, despite there being significant modest reductions in early death (by 7 days), haematoma expansion and SAEs, which is consistent with an antifibrinolytic effect. Tranexamic acid was safe, with no increase in thromboembolic events.
FUTURE WORK
Future work should focus on enrolling and treating patients early after stroke and identify which participants are most likely to benefit from haemostatic therapy. Large randomised trials are needed.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN93732214.
FUNDING
This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 35. See the NIHR Journals Library website for further project information. The project was also funded by the Pragmatic Trials, UK, funding call and the Swiss Heart Foundation in Switzerland.",2019,"Fewer patients experienced serious adverse events (SAEs) after treatment with tranexamic acid than with placebo by days 2 ( p = 0.027), 7 ( p = 0.020) and 90 ( p = 0.039).","['Adult patients (aged ≥\u200918 years) with ICH within 8 hours of onset', 'adults with spontaneous intracerebral haemorrhage (ICH', '2307 participants (tranexamic acid, n \u2009=\u20091152; placebo, n \u2009=\u20091155', '2325 participants (tranexamic acid, n \u2009=\u20091161; placebo, n \u2009=\u20091164) were recruited from 124 hospitals in 12 countries between 2013 and 2017', 'Acute stroke services at 124 hospitals in 12 countries (Denmark, Georgia, Hungary, Ireland, Italy, Malaysia, Poland, Spain, Sweden, Switzerland, Turkey and the UK', 'adults with spontaneous intracerebral haemorrhage', '12 countries enrolled participants, the majority (82.1%) were from the UK']","['tranexamic acid bolus followed by an 8-hour 1-g infusion or matching placebo (i.e. 0.9% saline', 'TICH-2 (Tranexamic acid', 'placebo', 'Tranexamic acid', 'tranexamic acid']","['deaths', 'Glasgow Coma Scale score', ""patient's functional status"", 'serious adverse events (SAEs', 'early death', 'thromboembolic events or seizures', 'thromboembolic events', 'functional status (death or dependency', 'functional status']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}]",2325.0,0.738803,"Fewer patients experienced serious adverse events (SAEs) after treatment with tranexamic acid than with placebo by days 2 ( p = 0.027), 7 ( p = 0.020) and 90 ( p = 0.039).","[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Flaherty', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Appleton', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bereczki', 'Affiliation': 'Department of Neurology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Beridze', 'Affiliation': 'The First University Clinic of Tbilisi State Medical University, Tbilisi, Georgia.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Ciccone', 'Affiliation': 'Neurology Unit, Azienda Socio Sanitaria Territoriale di Mantova, Mantua, Italy.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'Stroke Service, Adelaide and Meath Hospital, Tallaght, Ireland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Dineen', 'Affiliation': 'Radiological Sciences, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lelia', 'Initials': 'L', 'LastName': 'Duley', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Egea-Guerrero', 'Affiliation': 'UGC de Medicina Intensiva, Hospital Universitario Virgen del Rocío, IBiS/CSIC/Universidad de Sevilla, Seville, Spain.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & GEM, University of Nottingham, Derby, UK.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Karlinski', 'Affiliation': 'Second Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Kailash', 'Initials': 'K', 'LastName': 'Krishnan', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ann Charlotte', 'Initials': 'AC', 'LastName': 'Laska', 'Affiliation': 'Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Zhe Kang', 'Initials': 'ZK', 'LastName': 'Law', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ovesen', 'Affiliation': 'Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Department of Neurology, Copenhagen, Denmark.'}, {'ForeName': 'Serefnur', 'Initials': 'S', 'LastName': 'Ozturk', 'Affiliation': 'Department of Neurology, Selcuk University Medical Faculty, Konya, Turkey.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Roffe', 'Affiliation': 'Stroke Research, Faculty of Medicine and Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Peters', 'Affiliation': 'Department of Neurology and Stroke Center, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Scutt', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jegan', 'Initials': 'J', 'LastName': 'Thanabalan', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, National University of Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Werring', 'Affiliation': 'Stroke Research Centre, University College London Queen Square Institute of Neurology, Faculty of Brain Sciences of University College London, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Whynes', 'Affiliation': 'School of Economics, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Woodhouse', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23350']
856,30895797,Untargeted Metabolomics Differentiates l-Carnitine Treated Septic Shock 1-Year Survivors and Nonsurvivors.,"l-Carnitine is a candidate therapeutic for the treatment of septic shock, a condition that carries a ≥40% mortality. Responsiveness to l-carnitine may hinge on unique metabolic profiles that are not evident from the clinical phenotype. To define these profiles, we performed an untargeted metabolomic analysis of serum from 21 male sepsis patients enrolled in a placebo-controlled l-carnitine clinical trial. Although treatment with l-carnitine is known to induce changes in the sepsis metabolome, we found a distinct set of metabolites that differentiated 1-year survivors from nonsurvivors. Following feature alignment, we employed a new and innovative data reduction strategy followed by false discovery correction, and identified 63 metabolites that differentiated carnitine-treated 1-year survivors versus nonsurvivors. Following identification by MS/MS and database search, several metabolite markers of vascular inflammation were determined to be prominently elevated in the carnitine-treated nonsurvivor cohort, including fibrinopeptide A, allysine, and histamine. While preliminary, these results corroborate that metabolic profiles may be useful to differentiate l-carnitine treatment responsiveness. Furthermore, these data show that the metabolic signature of l-carnitine-treated nonsurvivors is associated with a severity of illness (e.g., vascular inflammation) that is not routinely clinically detected.",2019,"Following feature alignment, we employed a new and innovative data reduction strategy followed by false discovery correction, and identified 63 metabolites that differentiated carnitine-treated 1-year survivors versus nonsurvivors.",['21 male sepsis patients enrolled in a placebo-controlled l-carnitine clinical trial'],"['l-Carnitine', 'l-carnitine', 'Untargeted Metabolomics Differentiates l-Carnitine Treated Septic Shock', 'carnitine-treated 1-year survivors versus nonsurvivors']",[],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C1328813', 'cui_str': 'Metabolomic'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",[],21.0,0.0935151,"Following feature alignment, we employed a new and innovative data reduction strategy followed by false discovery correction, and identified 63 metabolites that differentiated carnitine-treated 1-year survivors versus nonsurvivors.","[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Karnovsky', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Puskarich', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, and Department of Emergency Medicine, School of Medicine , University of Minnesota , Minneapolis , Minnesota 55455 , United States.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Michailidis', 'Affiliation': 'Department of Statistics, College of Literature, Science and Art , University of Michigan and the Informatics Institute University of Florida , Gainesville , Flordia 32611 , United States.'}, {'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Jones', 'Affiliation': 'Emergency Medicine , University of Mississippi Medical Center , Jackson , Mississippi 39216 , United States.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Stringer', 'Affiliation': ''}]",Journal of proteome research,['10.1021/acs.jproteome.8b00774']
857,30865171,"Religiosity, Social Support, and Ethnic Identity: Exploring ""Resilience Resources"" for African-American Women Experiencing HIV-Related Stigma.","INTRODUCTION
African-American women living with HIV report substantial HIV-related stigma and depression. Resilience resources are strength-based resources that may moderate the effects of HIV-related stigma on poor psychosocial outcomes such as depression.
OBJECTIVE
To evaluate whether religiosity, social support, and ethnic identity moderate the effects of HIV-related stigma on depression among African-American women living with HIV.
METHODS
We used baseline data (May 2013-October 2015) from a randomized controlled trial testing the efficacy of an HIV-related stigma-reduction intervention among African-American women living with HIV in Chicago, IL, and Birmingham, AL, who were older than 18 years and currently receiving HIV services. To assess whether religiosity (7-item Religious Beliefs and Behaviors survey), social support (select subscales from the Medical Outcomes Study Social Support Survey), and ethnic identity (Commitment subscale from the Multigroup Ethnic Identity Measure) modified the relationship between HIV-related stigma (Stigma Scale for Chronic Illness) and depression (8-item Patient Health Questionnaire), we conducted 3 separate moderation analyses using linear regression with interactions between HIV-related stigma and each moderator of interest, adjusted for study site, age, time since diagnosis, and education.
RESULTS
Among 226 African-American women living with HIV, greater levels of HIV-related stigma were associated with greater depression in all 3 models (P < 0.05). Only religiosity modified this association (P = 0.04), with a weaker association among women reporting higher levels of religiosity.
CONCLUSIONS
The protective effects of religiosity may be leveraged in interventions for African-American women living with HIV struggling with HIV-related stigma.",2019,", greater levels of HIV-related stigma were associated with greater depression in all 3 models (P < 0.05).","['African-American women living with HIV struggling with HIV-related stigma', 'African-American women living with HIV report substantial HIV-related stigma and depression', 'African-American women living with HIV', 'African-American women living with HIV in Chicago, IL, and Birmingham, AL, who were older than 18 years and currently receiving HIV services', 'African-American Women Experiencing HIV-Related Stigma', '226 African-American women living with HIV']","['HIV-related stigma', 'HIV-related stigma-reduction intervention']","['levels of HIV-related stigma', 'religiosity (7-item Religious Beliefs and Behaviors survey), social support (select subscales from the Medical Outcomes Study Social Support Survey), and ethnic identity (Commitment subscale from the Multigroup Ethnic Identity Measure) modified the relationship between HIV-related stigma (Stigma Scale for Chronic Illness) and depression (8-item Patient Health Questionnaire', 'Religiosity, Social Support, and Ethnic Identity']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0681189', 'cui_str': 'Religiosity (observable entity)'}, {'cui': 'C0035045', 'cui_str': 'Religious Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0037438'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}]",,0.0562596,", greater levels of HIV-related stigma were associated with greater depression in all 3 models (P < 0.05).","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lipira', 'Affiliation': 'Department of Health Services, Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Williams', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Nevin', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Kemp', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Cohn', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Simoni', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, WA.'}, {'ForeName': 'Michele P', 'Initials': 'MP', 'LastName': 'Andrasik', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutch, Seattle, WA.'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'French', 'Affiliation': 'Stroger Hospital of Cook County, Ruth M. Rothstein CORE Center, Chicago, IL.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'Public Health Sciences Division, Fred Hutch, Seattle, WA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Rao', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002006']
858,30771686,Fish Oil Increases Specialized Pro-resolving Lipid Mediators in PAD (The OMEGA-PAD II Trial).,"BACKGROUND
N-3 polyunsaturated fatty acid (PUFA) supplementation has been associated with reduced mortality and inflammation in patients with cardiovascular disease. There are limited data on the effects of n-3 PUFA supplementation in patients with peripheral artery disease (PAD).
MATERIALS AND METHODS
The OMEGA-PAD II trial was a double-blinded, randomized, placebo-controlled trial to assess the effect of 3 mo of high-dose oral n-3 PUFA supplementation on inflammation, endothelial function, and walking ability in patients with PAD.
RESULTS
Twenty-four patients with claudication received 4.4 g/d of fish oil or placebo for 3 mo. Outcomes measured included high-sensitivity C-reactive protein levels, the omega-3 index, endothelial function as measured via flow-mediated vasodilation, walking impairment questionnaire, and a 6-min walk test. Plasma levels of specialized pro-resolving lipid mediators (SPMs) were measured by liquid-chromatography-tandem mass spectrometry. In patients treated with fish oil, the absolute mean omega-3 index significantly increased from baseline (fish oil: 7.2 ± 1.2%, P < 0.001; placebo: -0.4 ± 0.9%, P = 0.31; between-group P < 0.001). Furthermore, there were significant increases in several pathway markers of SPM biosynthesis, including several mono-hydroxyeicosapentaenoic acids and mono-hydroxydocosahexaenoic acids. We also observed significant increases in the SPM lipoxin A 5 (fish oil: 0.57 ± 0.70 pg/mL, P = 0.05; placebo: 0.01 ± 0.38 pg/mL, P = 0.93; between-group P = 0.04) and resolvin E3 (fish oil: 154 ± 171 pg/mL, P = 0.04; placebo: 32 ± 54 pg/mL, P = 0.08; between-group P = 0.04). There were no significant changes in high-sensitivity C-reactive protein, flow-mediated vasodilation, walking impairment questionnaire, or 6-min walk test in the fish oil group.
CONCLUSIONS
Fish oil increases SPMs in plasma of patients with PAD. Further studies are required to determine whether these early changes translate to clinical improvements in patients with PAD.",2019,"There were no significant changes in high-sensitivity C-reactive protein, flow-mediated vasodilation, walking impairment questionnaire, or 6-min walk test in the fish oil group.
","['patients with PAD', 'patients with peripheral artery disease (PAD', 'patients with cardiovascular disease']","['Fish Oil', 'placebo', 'N-3 polyunsaturated fatty acid (PUFA) supplementation', 'Fish oil', 'fish oil or placebo', 'n-3 PUFA supplementation']","['several pathway markers of SPM biosynthesis, including several mono-hydroxyeicosapentaenoic acids and mono-hydroxydocosahexaenoic acids', 'Plasma levels of specialized pro-resolving lipid mediators (SPMs', 'SPM lipoxin', 'high-sensitivity C-reactive protein, flow-mediated vasodilation, walking impairment questionnaire, or 6-min walk test', 'inflammation, endothelial function, and walking ability', 'absolute mean omega-3 index', 'high-sensitivity C-reactive protein levels, the omega-3 index, endothelial function as measured via flow-mediated vasodilation, walking impairment questionnaire, and a 6-min walk test']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0599689', 'cui_str': 'Lipoxins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",24.0,0.664383,"There were no significant changes in high-sensitivity C-reactive protein, flow-mediated vasodilation, walking impairment questionnaire, or 6-min walk test in the fish oil group.
","[{'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Ramirez', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, California.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Gasper', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, California; Vascular Surgery Section, Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Sukaynah A', 'Initials': 'SA', 'LastName': 'Khetani', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, California; Vascular Surgery Section, Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Zahner', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, California.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Hills', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, California.'}, {'ForeName': 'Pete T', 'Initials': 'PT', 'LastName': 'Mitchell', 'Affiliation': ""Center for Experimental Therapeutics and Reperfusion Injury, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital and Harvard Medical School, Building for Transformative Medicine, Boston, Massachusetts.""}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Sansbury', 'Affiliation': ""Center for Experimental Therapeutics and Reperfusion Injury, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital and Harvard Medical School, Building for Transformative Medicine, Boston, Massachusetts.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Conte', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, California.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Spite', 'Affiliation': ""Center for Experimental Therapeutics and Reperfusion Injury, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital and Harvard Medical School, Building for Transformative Medicine, Boston, Massachusetts.""}, {'ForeName': 'S Marlene', 'Initials': 'SM', 'LastName': 'Grenon', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, California. Electronic address: marlene.grenon@ucsf.edu.'}]",The Journal of surgical research,['10.1016/j.jss.2019.01.038']
859,31029260,Using SNOMED CT-encoded problems to improve ICD-10-CM coding-A randomized controlled experiment.,"OBJECTIVE
Clinical problems in the Electronic Health Record that are encoded in SNOMED CT can be translated into ICD-10-CM codes through the NLM's SNOMED CT to ICD-10-CM map (NLM Map). This study evaluates the potential benefits of using the map-generated codes to assist manual ICD-10-CM coding.
METHODS
De-identified clinic notes taken by the physician during an outpatient encounter were made available on a secure web server and randomly assigned for coding by professional coders with usual coding or map-assisted coding. Map-assisted coding made use of the problem list maintained by the physician and the NLM Map to suggest candidate ICD-10-CM codes to the coder. A gold standard set of codes for each note was established by the coders using a Delphi consensus process. Outcomes included coding time, coding reliability as measured by the Jaccard coefficients between codes from two coders with the same method of coding, and coding accuracy as measured by recall, precision and F-score according to the gold standard.
RESULTS
With map-assisted coding, the average coding time per note reduced by 1.5 min (p = 0.006). There was a small increase in coding reliability and accuracy (not statistical significant). The benefits were more pronounced in the more experienced than less experienced coders. Detailed analysis of cases in which the correct ICD-10-CM codes were not found by the NLM Map showed that most failures were related to omission in the problem list and suboptimal mapping of the problem list terms to SNOMED CT. Only 12% of the failures was caused by errors in the NLM Map.
CONCLUSION
Map-assisted coding reduces coding time and can potentially improve coding reliability and accuracy, especially for more experienced coders. More effort is needed to improve the accuracy of the map-suggested ICD-10-CM codes.",2019,"With map-assisted coding, the average coding time per note reduced by 1.5 min (p = 0.006).",['De-identified clinic notes taken by the physician during an outpatient encounter were made available on a'],['secure web server and randomly assigned for coding by professional coders with usual coding or map-assisted coding'],"['recall, precision and F-score', 'coding reliability and accuracy', 'coding time, coding reliability as measured by the Jaccard coefficients']","[{'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0268354,"With map-assisted coding, the average coding time per note reduced by 1.5 min (p = 0.006).","[{'ForeName': 'Kin Wah', 'Initials': 'KW', 'LastName': 'Fung', 'Affiliation': 'National Library of Medicine, Bethesda, MD, United States. Electronic address: kwfung@nlm.nih.gov.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'National Library of Medicine, Bethesda, MD, United States.'}, {'ForeName': 'S Trent', 'Initials': 'ST', 'LastName': 'Rosenbloom', 'Affiliation': 'Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Campbell', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, United States.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2019.03.002']
860,31048415,Etanercept With IVIg for Acute Kawasaki Disease: A Randomized Controlled Trial.,"OBJECTIVES
Patients with Kawasaki disease can develop life-altering coronary arterial abnormalities, particularly in those resistant to intravenous immunoglobulin (IVIg) therapy. We tested the tumor necrosis factor α receptor antagonist etanercept for reducing both IVIg resistance and coronary artery (CA) disease progression.
METHODS
In a double-blind multicenter trial, patients with Kawasaki disease received either etanercept (0.8 mg/kg; n = 100) or placebo ( n = 101) subcutaneously starting immediately after IVIg infusion. IVIg resistance was the primary outcome with prespecified subgroup analyses according to age, sex, and race. Secondary outcomes included echocardiographic CA measures within subgroups defined by coronary dilation ( z score >2.5) at baseline. We used generalized estimating equations to analyze z score change and a prespecified algorithm for change in absolute diameters.
RESULTS
IVIg resistance occurred in 22% (placebo) and 13% (etanercept) of patients ( P = .10). Etanercept reduced IVIg resistance in patients >1 year of age ( P = .03). In the entire population, 46 (23%) had a coronary z score >2.5 at baseline. Etanercept reduced coronary z score change in those with and without baseline dilation ( P = .04 and P = .001); no improvement occurred in the analogous placebo groups. Etanercept ( n = 22) reduced dilation progression compared with placebo ( n = 24) by algorithm in those with baseline dilation ( P = .03). No difference in the safety profile occurred between etanercept and placebo.
CONCLUSIONS
Etanercept showed no significant benefit in IVIg resistance in the entire population. However, preplanned analyses showed benefit in patients >1 year. Importantly, etanercept appeared to ameliorate CA dilation, particularly in patients with baseline abnormalities.",2019,Etanercept reduced coronary z score change in those with and without baseline dilation ( P = .04 and P = .001); no improvement occurred in the analogous placebo groups.,"['patients with Kawasaki disease', 'Patients with Kawasaki disease', 'Acute Kawasaki Disease']","['placebo', 'Etanercept With IVIg', 'etanercept', 'Etanercept']","['IVIg resistance', 'echocardiographic CA measures within subgroups defined by coronary dilation', 'CA dilation', 'safety profile', 'dilation progression', 'coronary z score change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026691', 'cui_str': 'Kawasaki Syndrome'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.490517,Etanercept reduced coronary z score change in those with and without baseline dilation ( P = .04 and P = .001); no improvement occurred in the analogous placebo groups.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Portman', 'Affiliation': ""Seattle Children's Research Institute, School of Medicine, University of Washington, Seattle, Washington; michael.portman@seattlechildrens.org.""}, {'ForeName': 'Nagib S', 'Initials': 'NS', 'LastName': 'Dahdah', 'Affiliation': 'Sainte Justine University Hospital Center, University of Montreal, Montreal, Canada.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Slee', 'Affiliation': 'Axio Research, Seattle, Washington.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Olson', 'Affiliation': ""Seattle Children's Research Institute, School of Medicine, University of Washington, Seattle, Washington.""}, {'ForeName': 'Nadine F', 'Initials': 'NF', 'LastName': 'Choueiter', 'Affiliation': ""Montefiore Children's Hospital, Albert Einstein College of Medicine, Bronx, New York; and.""}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Soriano', 'Affiliation': ""Seattle Children's Research Institute, School of Medicine, University of Washington, Seattle, Washington.""}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Buddhe', 'Affiliation': ""Seattle Children's Research Institute, School of Medicine, University of Washington, Seattle, Washington.""}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Altman', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2018-3675']
861,31070471,"Group IIA Secretory Phospholipase A 2 , Vascular Inflammation, and Incident Cardiovascular Disease.","Objective- Inflammation is a causal risk factor for cardiovascular disease (CVD). sPLA 2 -IIA (group IIA secretory phospholipase A 2 ) plays an integral role in regulating vascular inflammation. Although studies investigated sPLA 2 -IIA in secondary prevention, we prospectively evaluated sPLA 2 -IIA mass and genetic variants with CVD events in a primary prevention population with chronic inflammation. Approach and Results- The JUPITER trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin) randomized participants with LDL (low-density lipoprotein) <130 mg/dL and hsCRP (high-sensitivity C-reactive protein) ≥2 mg/L to high-intensity rosuvastatin versus placebo. Baseline and 1-year plasma sPLA 2 -IIA mass was measured (N=11 269 baseline; N=9620 1 year). We also identified genetic variants influencing sPLA 2 -IIA using genome-wide association and examined them with CVD. Three hundred thirteen incident CVD events occurred during follow-up. Baseline sPLA 2 -IIA mass (median, 25th-75th percentile: 3.81, 2.49-6.03 ng/mL) was associated with increased risk of CVD: risk factor-adjusted hazard ratio (95% CI; P) per SD increment: 1.22 (1.08-1.38; P=0.002). This remained significant (1.18; 1.04-1.35; P=0.01) after incrementally adjusting for hsCRP. Similar estimates were observed in rosuvastatin and placebo groups ( P treatment interaction>0.05). The rs11573156C variant in PLA2G2A (encoding sPLA 2 -IIA) had the strongest effect on sPLA 2 -II: median (25th-75th percentile, ng/mL) for CC and GG genotypes: 2.79 (1.97-4.01) and 7.38 (5.38-10.19), respectively; and had nonsignificant trend for higher CVD risk (hazard ratio, 1.11; 95% CI, 0.89-1.38; P=0.34). Conclusions- In the JUPITER population recruited on chronic inflammation, sPLA 2 -IIA mass was associated with CVD risk relating to vascular inflammation not fully reflected by hsCRP. Additional studies, including larger functional genetic and clinical studies, are needed to determine whether sPLA 2 -IIA may be a potential pharmacological target for primary prevention of CVD. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00239681.",2019,"The rs11573156C variant in PLA2G2A (encoding sPLA 2 -IIA) had the strongest effect on sPLA 2 -II: median (25th-75th percentile, ng/mL) for CC and GG genotypes: 2.79 (1.97-4.01) and 7.38 (5.38-10.19), respectively; and had nonsignificant trend for higher CVD risk (hazard ratio, 1.11; 95% CI, 0.89-1.38; P=0.34).",['participants with LDL (low-density lipoprotein) <130 mg/dL and hsCRP (high-sensitivity C-reactive protein) ≥2 mg/L to high-intensity'],"['rosuvastatin versus placebo', 'Conclusions', 'Rosuvastatin', 'rosuvastatin and placebo']","['Vascular Inflammation, and Incident Cardiovascular Disease', 'CVD events', 'sPLA 2 -IIA', 'risk of CVD: risk factor-adjusted hazard ratio', 'higher CVD risk', 'Baseline and 1-year plasma sPLA 2 -IIA mass', 'Baseline sPLA 2 -IIA mass']","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0947751', 'cui_str': 'Vascular inflammations'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2756983', 'cui_str': 'SPLA2 Phospholipases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.414481,"The rs11573156C variant in PLA2G2A (encoding sPLA 2 -IIA) had the strongest effect on sPLA 2 -II: median (25th-75th percentile, ng/mL) for CC and GG genotypes: 2.79 (1.97-4.01) and 7.38 (5.38-10.19), respectively; and had nonsignificant trend for higher CVD risk (hazard ratio, 1.11; 95% CI, 0.89-1.38; P=0.34).","[{'ForeName': 'Akintunde O', 'Initials': 'AO', 'LastName': 'Akinkuolie', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Lawler', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Audrey Y', 'Initials': 'AY', 'LastName': 'Chu', 'Affiliation': 'Merck Research Laboratories, Boston, MA (A.Y.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Caulfield', 'Affiliation': 'Department of Endocrinology & CVD, Quest Diagnostics Nichols Institute, San Juan Capistrano, CA (M.C., J.M.).'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Mu', 'Affiliation': 'Department of Endocrinology & CVD, Quest Diagnostics Nichols Institute, San Juan Capistrano, CA (M.C., J.M.).'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Medical Evidence & Observational Research, Global Medical Affairs (B.D., F.N.), AstraZeneca R&D, Mölndal, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Nyberg', 'Affiliation': 'Medical Evidence & Observational Research, Global Medical Affairs (B.D., F.N.), AstraZeneca R&D, Mölndal, Sweden.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hurt-Camejo', 'Affiliation': 'Cardiovascular & Metabolic Diseases, Innovative Medicines (E.H.-C.), AstraZeneca R&D, Mölndal, Sweden.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Chasman', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.118.311894']
862,30939531,Plasma Cystatin C Associates With HIV-Associated Neurocognitive Disorder but Is a Poor Diagnostic Marker in Antiretroviral Therapy-Treated Individuals.,"OBJECTIVE
To examine associations between plasma cystatin C and neurocognitive impairment (NCI) and its performance as a diagnostic marker before and during initial antiretroviral therapy (ART).
METHODS
Multivariable logistic regression and generalized estimating equations examined associations with NCI, determined by neuropsychological measurements, in participants of a 48-week randomized clinical trial of initial ART. Receiver operator characteristic curves examined diagnostic models of NCI.
RESULTS
Cystatin C was associated with NCI before ART [odds ratio (OR) 3.4 (95% CI: 1.2 to 9.4) for each 2-fold increase in baseline levels] and during 48 weeks of ART, in models that excluded baseline measurements [OR 3.0 (1.2 to 7.8) for each 2-fold increase in time-updated levels]. The strength of association increased with more severe impairment using HIV-associated neurocognitive disorder criteria [OR 2.2 (0.8 to 6.0) with asymptomatic NCI and OR 4.0 (1.5 to 11.0) with mild neurocognitive disorder or HIV-associated dementia vs. no impairment, for each 2-fold increase in time-updated levels] or by global development score [OR 2.6 (1.1 to 6.3) with mild impairment and OR 4.6 (1.1 to 18.9) with moderate or severe impairment vs. no impairment]. Cystatin C performed poorly as a diagnostic marker for NCI, however, with an area under the receiver operator characteristic curve of 0.58 at baseline and 0.54 at week 48.
CONCLUSIONS
Higher plasma cystatin C levels were significantly associated with NCI, but these levels did not seem to be useful as a diagnostic marker for this condition.",2019,"Cystatin C performed poorly as a diagnostic marker for NCI, however, with an area under the receiver operator characteristic curve of 0.58 at baseline and 0.54 at week 48.
",[],[],"['plasma cystatin C and neurocognitive impairment (NCI', 'plasma cystatin C levels', 'time-updated levels', 'baseline levels']",[],[],"[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0912158,"Cystatin C performed poorly as a diagnostic marker for NCI, however, with an area under the receiver operator characteristic curve of 0.58 at baseline and 0.54 at week 48.
","[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Kalayjian', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, MetroHealth Med Center, Cleveland, OH.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Robertson', 'Affiliation': 'Department of Neurology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Albert', 'Affiliation': 'Infectious Diseases, Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, OH.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Cincinnati School of Medicine, Cincinnati, OH.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Babafemi O', 'Initials': 'BO', 'LastName': 'Taiwo', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002016']
863,30707756,A randomized study to improve care for young women with breast cancer at community and academic medical oncology practices in the United States: The Young and Strong study.,"BACKGROUND
The authors conducted a cluster randomized study to determine the effect of an exportable educational intervention for young women with breast cancer (YWI) on improving care.
METHODS
Sites were randomized 1:1 to the YWI or a contact time control physical activity intervention (PAI) stratified by academic or community site. Up to 15 women aged ≤45 years with newly diagnosed breast cancer were enrolled at each of 14 academic sites and 10 were enrolled at each of 40 community sites. The primary endpoint, attention to fertility, was ascertained by medical record review. Statistical inferences concerning the effect of the intervention used general estimating equations for clustered data.
RESULTS
A total of 467 patients across 54 sites were enrolled between July 2012 and December 2013. The median age of the patients at the time of diagnosis was 40 years (range, 22-45 years). Attention to fertility by 3 months was observed in 55% of patients in the YWI and 58% of patients in the PAI (P = .88). Rates were found to be strongly correlated with age (P < .0001), and were highest in patients aged <30 years. Attention to genetics was similar (80% in the YWI and 81% in the PAI), whereas attention to emotional health was higher in patients in the YWI (87% vs 76%; estimated odds ratio, 2.63 [95% confidence interval, 1.20-5.76; P = .016]). Patients rated both interventions as valuable in providing education (64% in the YWI and 63% in the PAI).
CONCLUSIONS
The current study failed to demonstrate differences in attention to fertility with an intervention to improve care for women with breast cancer, although attention to fertility was found to be higher than expected in both groups and emotional health was improved in the YWI group. Greater attention to young women with breast cancer in general may promote more comprehensive care for this population.",2019,"Patients rated both interventions as valuable in providing education (64% in the YWI and 63% in the PAI).
","['young women with breast cancer (YWI', 'women with breast cancer', 'young women with breast cancer at community and academic medical oncology practices in the United States', '467 patients across 54 sites were enrolled between July 2012 and December 2013', '15 women aged ≤45\xa0years with newly diagnosed breast cancer were enrolled at each of 14 academic sites and 10 were enrolled at each of 40 community sites', 'young women with breast cancer']","['exportable educational intervention', 'YWI or a contact time control physical activity intervention (PAI) stratified by academic or community site']","['attention to fertility', 'emotional health', 'Attention to fertility', 'attention to emotional health']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}, {'cui': 'C4517784', 'cui_str': '467 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0303135', 'cui_str': '10Be radioisotope'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",15.0,0.047467,"Patients rated both interventions as valuable in providing education (64% in the YWI and 63% in the PAI).
","[{'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Greaney', 'Affiliation': 'Department of Kinesiology, University of Rhode Island at Kingston, Kingston, Rhode Island.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Sprunck-Harrild', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Shoshana M', 'Initials': 'SM', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Baker', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'J Russell', 'Initials': 'JR', 'LastName': 'Hoverman', 'Affiliation': 'Texas Oncology PA, Austin, Texas.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Emmons', 'Affiliation': 'Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.31984']
864,31141104,P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes.,"Importance
Physician behavior in response to knowledge of a patient's CYP2C19 clopidogrel metabolizer status is unknown.
Objective
To investigate the association of mandatory reporting of CYP2C19 pharmacogenomic testing, provided to investigators with no direct recommendations on how to use these results, with changes in P2Y12 inhibitor use, particularly clopidogrel, in the Randomized Trial to Compare the Safety of Rivaroxaban vs Aspirin in Addition to Either Clopidogrel or Ticagrelor in Acute Coronary Syndrome (GEMINI-ACS-1) clinical trial.
Design, Setting, and Participants
The GEMINI-ACS-1 trial compared rivaroxaban, 2.5 mg twice daily, with aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor (provided), in patients with recent acute coronary syndromes (ACS). The trial included 371 clinical centers in 21 countries and 3037 patients with ACS. Data were analyzed between May 2017 and February 2019.
Interventions
Investigators were required to prestipulate their planned response to CYP2C19 metabolizer status. In response to a regulatory mandate, results for all patients were reported to investigators approximately 1 week after randomization.
Main Outcomes and Measures
Reasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events were collected.
Results
Of 3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with clopidogrel. Investigators prestipulated that they would use CYP2C19 metabolizer status to change P2Y12 inhibitor in 48.5% of genotyped clopidogrel-treated patients (n = 642 of 1324) and 5.5% of genotyped ticagrelor-treated patients (n = 93 of 1692). P2Y12 inhibitor switching for any reason occurred in 197 patients and was more common in patients treated with ticagrelor (146 of 1704 [8.6%]) compared with clopidogrel (51 of 1333 [3.8%]). Of patients initially treated with ticagrelor, only 1 (0.1% overall; 0.7% of all who switched) was switched based on CYP2C19 status. Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status. Of 48 patients (3.6%) with reduced metabolizer status treated initially with clopidogrel, 15 (31.3%) were switched based on metabolizer status, including 48.1% (13 of 27) in which switching was prestipulated.
Conclusions and Relevance
Physicians were evenly split on how to respond to knowledge of CYP2C19 metabolizer status in clopidogrel-treated patients. Mandatory provision of this information rarely prompted P2Y12 inhibitor switching overall, including a minority of patients with reduced metabolizer status. These findings highlight the clinical equipoise among physicians regarding use of this information and the reluctance to use information from routine genotyping in the absence of definitive clinical trial data demonstrating the efficacy of this approach.
Clinical Trial Registration
ClinicalTrials.gov identifier: NCT02293395.",2019,"Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status.","['371 clinical centers in 21 countries and 3037 patients with ACS', 'patients with recent acute coronary syndromes (ACS', '3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with', '48 patients (3.6%) with reduced metabolizer status treated initially with', 'Acute Coronary Syndrome']","['CYP2C19 Clopidogrel Metabolizer', 'rivaroxaban', 'ticagrelor', 'Clopidogrel or Ticagrelor', 'aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor', 'Rivaroxaban vs Aspirin', 'clopidogrel']",['Measures\n\n\nReasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events'],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",3037.0,0.0356846,"Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar and Dutch Network for Cardiovascular Research, the Netherlands.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Insituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'DHU FIRE, Université Paris-Diderot, AP-HP and Inserm U-1148, Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'University of Freiburg, Faculty of Medicine, Internal Medicine III, Freiburg, Germany.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alexei N', 'Initials': 'AN', 'LastName': 'Plotnikov', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'PERFUSE Study Group, Beth Israel Deaconess Hospital, Harvard Medical School, Boston, Massachusetts.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1510']
865,30660721,Model-based pain and function outcome trajectory types for patients undergoing knee arthroplasty: a secondary analysis from a randomized clinical trial.,"OBJECTIVE
Knee arthroplasty (KA) is an effective surgical procedure. However, clinical studies suggest that a considerable number of patients continue to experience substantial pain and functional loss following surgical recovery. We aimed to estimate pain and function outcome trajectory types for persons undergoing KA, and to determine the relationship between pain and function trajectory types, and pre-surgery predictors of trajectory types.
DESIGN
Participants were 384 patients who took part in the KA Skills Training randomized clinical trial. Pain and function were assessed at 2-week pre- and 2-, 6-, and 12-months post-surgery. Piecewise latent class growth models were used to estimate pain and function trajectories. Pre-surgery variables were used to predict trajectory types.
RESULTS
There was strong evidence for two trajectory types, labeled as good and poor, for both Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function scores. Model estimated rates of the poor trajectory type were 18% for pain and function. Dumenci's latent kappa between pain and function trajectory types was 0.71 (95% CI: 0.61-0.80). Pain catastrophizing and number of painful body regions were significant predictors of poor pain and function outcomes. Outcome-specific predictors included low income for poor pain and baseline pain and younger age for poor function.
CONCLUSIONS
Among adults undergoing KA, approximately one-fifth continue to have persistent pain, poor function, or both. Although the poor pain and function trajectory types tend to go together within persons, a significant number experience either poor pain or function but not both, suggesting heterogeneity among persons who do not fully benefit from KA.",2019,"There was strong evidence for two trajectory types, labeled as good and poor, for both Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function scores.","['patients undergoing knee arthroplasty', 'persons undergoing KA', 'Participants were 384 patients who took part in the KA Skills Training randomized clinical trial']",['Knee arthroplasty (KA'],"['Pain catastrophizing and number of painful body regions', 'Pain and function', 'low income for poor pain and baseline pain and younger age for poor function', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005898', 'cui_str': 'Body Regions'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",384.0,0.047035,"There was strong evidence for two trajectory types, labeled as good and poor, for both Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function scores.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dumenci', 'Affiliation': 'Department of Epidemiology and Biostatistics, 1301 Cecil B. Moore, Ave., Ritter Annex, Room 939, Temple University, Philadelphia, PA, USA. Electronic address: ldumenci@temple.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Perera', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Pain Prevention and Treatment Research, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Ang', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Slover', 'Affiliation': 'Department of Orthopaedic Surgery, New York University Longone Medical Center, New York, NY, USA.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Riddle', 'Affiliation': 'Departments of Physical Therapy, Orthopaedic Surgery and Rheumatology, Virginia Commonwealth University, Richmond, VA, USA.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2019.01.004']
866,30928279,Acute estradiol treatment reduces skeletal muscle protein breakdown markers in early- but not late-postmenopausal women.,"OBJECTIVES
Menopause and decline in estradiol (E 2 ) may contribute to sarcopenia (i.e., age-related decline in muscle mass and strength) in women. E 2 may directly impact skeletal muscle protein breakdown via estrogen receptor (ER) signaling, primarily ERα. It is not yet known whether: 1) E 2 regulates pathways of skeletal muscle protein breakdown; 2) E 2 -mediated changes in protein breakdown markers are associated with ERα activation and insulin sensitivity; and 3) the effects of E 2 on protein breakdown markers differ by increasing time since menopause.
STUDY DESIGN
We studied 27 women who were ≤6 years past menopause (early postmenopausal, EPM; n = 13) or ≥10 years past menopause (late postmenopausal, LPM; n = 14). Fasted skeletal muscle samples were collected following 1 week of transdermal E 2 or placebo treatment in a randomized cross-over design.
MAIN OUTCOME MEASURES
We analyzed for cytosolic protein content of the: 1) structural proteins myosin heavy chain (MHC) and tropomyosin; and 2) protein regulatory markers: protein kinase B (Akt), muscle-specific ring finger protein1 (MuRF1), atrogin1, and forkhead box O3 (FOXO3) using Western blot.
RESULTS
In response to acute E 2 , FOXO3 activation (dephosphorylation) and MuRF1 protein expression decreased in EPM but increased in LPM women (p < 0.05). ERα activation was not associated with these protein breakdown markers, but FOXO3 activation tended to be inversely correlated (r = -0.318, p = 0.065) to insulin sensitivity.
CONCLUSIONS
These preliminary studies suggest the effects of E 2 on skeletal muscle protein breakdown markers were dependent on time since menopause, which is consistent with our previous study on insulin sensitivity.",2019,"In response to acute E 2 , FOXO3 activation (dephosphorylation) and MuRF1 protein expression decreased in EPM but increased in LPM women (p < 0.05).","['early- but not late-postmenopausal women', '27 women who were ≤6\u202fyears past menopause (early postmenopausal, EPM; n\u202f=\u202f13) or ≥10\u202fyears past menopause (late postmenopausal, LPM; n\u202f=\u202f14']","['placebo', 'Acute estradiol treatment']","['skeletal muscle protein breakdown markers', 'FOXO3 activation', 'FOXO3 activation (dephosphorylation) and MuRF1 protein expression decreased in EPM', 'ERα activation']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",27.0,0.042107,"In response to acute E 2 , FOXO3 activation (dephosphorylation) and MuRF1 protein expression decreased in EPM but increased in LPM women (p < 0.05).","[{'ForeName': 'Young-Min', 'Initials': 'YM', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Keller', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Shauna S', 'Initials': 'SS', 'LastName': 'Runchey', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; VA Eastern Colorado Health Care System, Geriatric Research Education and Clinical Center (GRECC), Denver, CO, USA.'}, {'ForeName': 'Rachael E', 'Initials': 'RE', 'LastName': 'Van Pelt', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; VA Eastern Colorado Health Care System, Geriatric Research Education and Clinical Center (GRECC), Denver, CO, USA.'}, {'ForeName': 'Chounghun', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Physical Education, Inha University, Incheon, South Korea.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Jankowski', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; College of Nursing, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Kerrie L', 'Initials': 'KL', 'LastName': 'Moreau', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; VA Eastern Colorado Health Care System, Geriatric Research Education and Clinical Center (GRECC), Denver, CO, USA. Electronic address: Kerrie.Moreau@ucdenver.edu.'}]",Steroids,['10.1016/j.steroids.2019.03.008']
867,30793698,Different temperature thresholds for antipyretic intervention in critically ill children with fever due to infection: the FEVER feasibility RCT.,"BACKGROUND
Fever accelerates host immune system control of pathogens but at a high metabolic cost. The optimal approach to fever management and the optimal temperature thresholds used for treatment in critically ill children are unknown.
OBJECTIVES
To determine the feasibility of conducting a definitive randomised controlled trial (RCT) to evaluate the clinical effectiveness and cost-effectiveness of different temperature thresholds for antipyretic management.
DESIGN
A mixed-methods feasibility study comprising three linked studies - (1) a qualitative study exploring parent and clinician views, (2) an observational study of the epidemiology of fever in children with infection in paediatric intensive care units (PICUs) and (3) a pilot RCT with an integrated-perspectives study.
SETTING
Participants were recruited from (1) four hospitals in England via social media (for the FEVER qualitative study), (2) 22 PICUs in the UK (for the FEVER observational study) and (3) four PICUs in England (for the FEVER pilot RCT).
PARTICIPANTS
(1) Parents of children with relevant experience were recruited to the FEVER qualitative study, (2) patients who were unplanned admissions to PICUs were recruited to the FEVER observational study and (3) children admitted with infection requiring mechanical ventilation were recruited to the FEVER pilot RCT. Parents of children and clinicians involved in the pilot RCT.
INTERVENTIONS
The FEVER qualitative study and the FEVER observational study had no interventions. In the FEVER pilot RCT, children were randomly allocated (1 : 1) using research without prior consent (RWPC) to permissive (39.5 °C) or restrictive (37.5 °C) temperature thresholds for antipyretics during their PICU stay while mechanically ventilated.
MAIN OUTCOME MEASURES
(1) The acceptability of FEVER, RWPC and potential outcomes (in the FEVER qualitative study), (2) the size of the potentially eligible population and the temperature thresholds used (in the FEVER observational study) and (3) recruitment and retention rates, protocol adherence and separation between groups and distribution of potential outcomes (in the FEVER pilot RCT).
RESULTS
In the FEVER qualitative study, 25 parents were interviewed and 56 clinicians took part in focus groups. Both the parents and the clinicians found the study acceptable. Clinicians raised concerns regarding temperature thresholds and not using paracetamol for pain/discomfort. In the FEVER observational study, 1853 children with unplanned admissions and infection were admitted to 22 PICUs between March and August 2017. The recruitment rate was 10.9 per site per month. The majority of critically ill children with a maximum temperature of > 37.5 °C received antipyretics. In the FEVER pilot RCT, 100 eligible patients were randomised between September and December 2017 at a recruitment rate of 11.1 per site per month. Consent was provided for 49 out of 51 participants in the restrictive temperature group, but only for 38 out of 49 participants in the permissive temperature group. A separation of 0.5 °C (95% confidence interval 0.2 °C to 0.8 °C) between groups was achieved. A high completeness of outcome measures was achieved. Sixty parents of 57 children took part in interviews and/or completed questionnaires and 98 clinicians took part in focus groups or completed a survey. Parents and clinicians found the pilot RCT and RWPC acceptable. Concerns about children being in pain/discomfort were cited as reasons for withdrawal and non-consent by parents and non-adherence to the protocol by clinicians.
LIMITATIONS
Different recruitment periods for observational and pilot studies may not fully reflect the population that is eligible for a definitive RCT.
CONCLUSIONS
The results identified barriers to delivering the definitive FEVER RCT, including acceptability of the permissive temperature threshold. The findings also provided insight into how these barriers may be overcome, such as by limiting the patient inclusion criteria to invasive ventilation only and by improved site training. A definitive FEVER RCT using a modified protocol should be conducted, but further work is required to agree important outcome measures for clinical trials among critically ill children.
TRIAL REGISTRATION
The FEVER observational study is registered as NCT03028818 and the FEVER pilot RCT is registered as Current Controlled Trials ISRCTN16022198.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 5. See the NIHR Journals Library website for further project information.",2019,"Consent was provided for 49 out of 51 participants in the restrictive temperature group, but only for 38 out of 49 participants in the permissive temperature group.","['51 participants in the restrictive temperature group, but only for 38 out of 49 participants in the permissive temperature group', '1853 children with unplanned admissions and infection were admitted to 22 PICUs between March and August 2017', 'critically ill children', 'Participants were recruited from (1) four hospitals in England via social media (for the FEVER qualitative study), (2) 22 PICUs in the UK (for the FEVER observational study) and (3) four PICUs in England (for the FEVER pilot RCT', '100 eligible patients were randomised between September and December 2017 at a recruitment rate of 11.1 per site per month', 'Sixty parents of 57 children took part in interviews and/or completed questionnaires and 98 clinicians took part in focus groups or completed a survey', 'children with infection in paediatric intensive care units (PICUs) and (3) a pilot RCT with an integrated-perspectives study', '25 parents were interviewed and 56 clinicians took part in focus groups', '1) Parents of children with relevant experience were recruited to the FEVER qualitative study, (2) patients who were unplanned admissions to PICUs were recruited to the FEVER observational study and (3) children admitted with infection requiring mechanical ventilation were recruited to the FEVER pilot RCT', 'critically ill children with fever due to infection', 'critically ill children with a maximum temperature of >\u200937.5\u2009°C received']","['research without prior consent (RWPC) to permissive (39.5\u2009°C) or restrictive (37.5\u2009°C) temperature thresholds for antipyretics during their PICU stay while mechanically ventilated', 'antipyretics', 'paracetamol', 'antipyretic intervention']","['recruitment rate', 'acceptability of FEVER, RWPC and potential outcomes']","[{'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450336', 'cui_str': '1853'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C4304689', 'cui_str': 'Fever co-occurrent and due to infection'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}]","[{'cui': 'C0035168'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",1853.0,0.092386,"Consent was provided for 49 out of 51 participants in the restrictive temperature group, but only for 38 out of 49 participants in the permissive temperature group.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Respiratory, Critical Care and Anaesthesia Unit, University College London Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Woolfall', 'Affiliation': 'Department of Psychological Sciences, North West Hub for Trials Methodology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Deja', 'Affiliation': 'Department of Psychological Sciences, North West Hub for Trials Methodology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Wulff', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Alexina', 'Initials': 'A', 'LastName': 'Mason', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Agbeko', 'Affiliation': ""Paediatric Intensive Care Unit, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Draper', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Fenn', 'Affiliation': 'Patient/Parent Representative, London, UK.'}, {'ForeName': 'Doug W', 'Initials': 'DW', 'LastName': 'Gould', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Koelewyn', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Klein', 'Affiliation': 'Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mackerness', 'Affiliation': ""Paediatric Intensive Care Unit, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Lauran', 'Initials': 'L', 'LastName': ""O'Neill"", 'Affiliation': 'Respiratory, Critical Care and Anaesthesia Unit, University College London Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Padmanabhan', 'Initials': 'P', 'LastName': 'Ramnarayan', 'Affiliation': ""Children's Acute Transport Service, Great Ormond Street Hospital, London, UK.""}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Tibby', 'Affiliation': ""Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Lyvonne', 'Initials': 'L', 'LastName': 'Tume', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Watkins', 'Affiliation': 'Patient/Parent Representative, London, UK.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Thorburn', 'Affiliation': ""Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wellman', 'Affiliation': ""Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23050']
868,30782304,Sports Therapy Interventions Following Total Hip Replacement.,"BACKGROUND
Sport rehabilitation is a reimbursable intervention assisting reintegration and self-help. In this study, we measured the effects of sport rehabilitation on muscle strength around the hip joint at 1 year after surgery, as well as cardiopulmonary endurance performance and stability of stance, in patients who had undergone a first implantation of a total hip endoprosthesis (total hip replacement, THR) as a treatment for osteoarthritis of the hip.
METHODS
160 patients were randomly allotted either to an intervention group with intensive sport rehabilitation for the first year or to a control group. At three time points (baseline, six and twelve months after surgery), measurements were made of muscular strength around the hip joint (with isokinetic dynamometry), stability of stance, and endurance performance. The primary endpoint was the change in strength of the hip extensors, abductors, flexors, and adductors at twelve months after surgery.
RESULTS
With respect to the primary endpoint, the results were not significantly better in patients who had received sport rehabilitation than in those who had not. At one year, the patients in the intervention group had less pain as measured by the WOMAC pain score (p = 0.023), though the size of this effect was small (r = 0.27). Health-related quality of life was higher in the intervention group at six months, albeit with a small effect size (p = 0.036, r = 0.25); this was no longer demonstrable at one year. The other parameters studied displayed no significant changes.
CONCLUSION
This trial did not demonstrate any significant benefit of sports rehabilitation on functional outcomes in patients who had undergone total hip replacement. Nonetheless, positive trends after the intervention were seen in some parameters. The unexpectedly high dropout rate had been underestimated in the planning phase of the trial; further trials with larger numbers of patients should be performed.",2019,"Health-related quality of life was higher in the intervention group at six months, albeit with a small effect size (p = 0.036, r = 0.25); this was no longer demonstrable at one year.","['patients who had undergone total hip replacement', 'patients who had undergone a first implantation of a total hip endoprosthesis (total hip replacement, THR) as a treatment for osteoarthritis of the hip', '160 patients']","['intervention group with intensive sport rehabilitation', 'Sports Therapy Interventions', 'Total Hip Replacement', 'sport rehabilitation', 'sports rehabilitation']","['cardiopulmonary endurance performance and stability of stance', 'muscular strength around the hip joint (with isokinetic dynamometry), stability of stance, and endurance performance', 'pain', 'muscle strength', 'change in strength of the hip extensors, abductors, flexors, and adductors at twelve months after surgery', 'Health-related quality of life', 'functional outcomes', 'WOMAC pain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C4704931', 'cui_str': 'Endoprosthesis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0019558', 'cui_str': 'Acetabulofemoral Joint'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",160.0,0.0503402,"Health-related quality of life was higher in the intervention group at six months, albeit with a small effect size (p = 0.036, r = 0.25); this was no longer demonstrable at one year.","[{'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Beck', 'Affiliation': 'University Center of Orthopedic and Trauma Surgery, TU Dresden, Section Sports Medicine and Rehabilitation, Dresden; University Center of Orthopedic and Trauma Surgery, TU Dresden, Dresden.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Beyer', 'Affiliation': ''}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Gering', 'Affiliation': ''}, {'ForeName': 'Klaus-Peter', 'Initials': 'KP', 'LastName': 'Günther', 'Affiliation': ''}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Lützner', 'Affiliation': ''}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Walther', 'Affiliation': ''}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Stiehler', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0001']
869,31036759,A Randomized Trial of Magnesium Oxide and Oral Carbon Adsorbent for Coronary Artery Calcification in Predialysis CKD.,"BACKGROUND
Developing strategies for managing coronary artery calcification (CAC) in patients with CKD is an important clinical challenge. Experimental studies have demonstrated that magnesium inhibits vascular calcification, whereas the uremic toxin indoxyl sulfate aggravates it.
METHODS
To assess the efficacy of magnesium oxide (MgO) and/or the oral carbon adsorbent AST-120 for slowing CAC progression in CKD, we conducted a 2-year, open-label, randomized, controlled trial, enrolling patients with stage 3-4 CKD with risk factors for CAC (diabetes mellitus, history of cardiovascular disease, high LDL cholesterol, or smoking). Using a two-by-two factorial design, we randomly assigned patients to an MgO group or a control group, and to an AST-120 group or a control group. The primary outcome was percentage change in CAC score.
RESULTS
We terminated the study prematurely after an interim analysis with the first 125 enrolled patients (of whom 96 completed the study) showed that the median change in CAC score was significantly smaller for MgO versus control (11.3% versus 39.5%). The proportion of patients with an annualized percentage change in CAC score of ≥15% was also significantly lower for MgO compared with control (23.9% versus 62.0%). However, MgO did not suppress the progression of thoracic aorta calcification. The MgO group's dropout rate was higher than that of the control group (27% versus 17%), primarily due to diarrhea. The percentage change in CAC score did not differ significantly between the AST-120 and control groups.
CONCLUSIONS
MgO, but not AST-120, appears to be effective in slowing CAC progression. Larger-scale trials are warranted to confirm these findings.",2019,"The MgO group's dropout rate was higher than that of the control group (27% versus 17%), primarily due to diarrhea.","['Coronary Artery Calcification in Predialysis CKD', 'enrolling patients with stage 3-4 CKD with risk factors for CAC (diabetes mellitus, history of cardiovascular disease, high LDL cholesterol, or smoking', 'patients with CKD']","['magnesium', 'magnesium oxide (MgO) and/or the oral carbon adsorbent AST-120', 'MgO group or a control group, and to an AST-120 group or a control group', 'Magnesium Oxide and Oral Carbon Adsorbent']","['CAC score', 'median change in CAC score', 'progression of thoracic aorta calcification', 'dropout rate', 'percentage change in CAC score']","[{'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0350056', 'cui_str': 'Adsorbents (product)'}, {'cui': 'C0052561', 'cui_str': 'AST 120'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1522460', 'cui_str': 'Thoracic aorta structure (body structure)'}]",125.0,0.0353884,"The MgO group's dropout rate was higher than that of the control group (27% versus 17%), primarily due to diarrhea.","[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sakaguchi', 'Affiliation': 'Departments of Inter-Organ Communication Research in Kidney Disease.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hamano', 'Affiliation': 'Departments of Inter-Organ Communication Research in Kidney Disease, hamatea@kid.med.osaka-u.ac.jp.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Obi', 'Affiliation': 'Harold Simmons Center for Kidney Disease Research and Epidemiology, Division of Nephrology and Hypertension, University of California Irvine, Orange, California.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Monden', 'Affiliation': 'Department of Internal Medicine, Kisei Hospital, Osaka, Japan; and.'}, {'ForeName': 'Tatsufumi', 'Initials': 'T', 'LastName': 'Oka', 'Affiliation': 'Nephrology.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Nephrology.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Matsui', 'Affiliation': 'Nephrology.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': 'Nephrology.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Matsumoto', 'Affiliation': 'Nephrology.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Nephrology.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Takabatake', 'Affiliation': 'Nephrology.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Nephrology.'}, {'ForeName': 'Jun-Ya', 'Initials': 'JY', 'LastName': 'Kaimori', 'Affiliation': 'Advanced Technology for Transplantation.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Moriyama', 'Affiliation': 'Health Care Division, Health and Counseling Center, Osaka University, Toyonaka, Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Yamamoto', 'Affiliation': 'Health Care Division, Health and Counseling Center, Osaka University, Toyonaka, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Horio', 'Affiliation': 'Functional Diagnostic Science, and.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Isaka', 'Affiliation': 'Nephrology.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2018111150']
870,31047905,Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM).,"BACKGROUND
Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies).
OBJECTIVE
To report participants' sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). UPSTREAM is a randomised controlled trial evaluating whether symptoms are noninferior and surgery rates are lower if UDS is included.
DESIGN, SETTING, AND PARTICIPANTS
A total of 820 men (≥18 yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments.
INTERVENTION
Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary outcome is International Prostate Symptom Score (IPSS) and the key secondary outcome is surgery rates 18 mo after randomisation. International Consultation on Incontinence Questionnaires were captured for MLUTS, sexual function, and UDS satisfaction. Baseline clinical and patient-reported outcome measures (PROMs), and UDS findings were informally compared between arms. Trends across age groups for urinary and sexual PROMs were evaluated with a Cuzick's test, and questionnaire items were compared using Pearson's correlation coefficient.
RESULTS AND LIMITATIONS
Storage LUTS, notably nocturia, and impaired sexual function are prominent in men being assessed for surgery. Sociodemographic and clinical evaluations were similar between arms. Overall mean IPSS and quality of life scores were 18.94 and 4.13, respectively. Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms. Men undergoing UDS testing expressed high satisfaction with the procedure.
CONCLUSIONS
Men being considered for surgery have additional clinical features that may affect treatment decision making and outcomes, notably storage LUTS and impaired sexual function.
PATIENT SUMMARY
We describe initial assessment findings from a large clinical study of the treatment pathway for men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery. We report the patient characteristics and diagnostic test results, including symptom questionnaires, bladder diaries, flow rate tests, and urodynamics.",2019,"Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms.","['men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery', '820 men (≥18\u2009yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments', 'Men undergoing UDS testing expressed high satisfaction with the procedure', 'Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms']","['Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm']","['Overall mean IPSS and quality of life scores', 'International Prostate Symptom Score (IPSS', 'symptom questionnaires, bladder diaries, flow rate tests, and urodynamics', 'incontinence, nocturia, and erectile dysfunction', 'outcome measures (PROMs), and UDS findings', 'daytime frequency and voiding symptoms', 'Storage LUTS, notably nocturia, and impaired sexual function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0042078', 'cui_str': 'Urology Department, Hospital'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}]",820.0,0.17348,"Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Lewis', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chapple', 'Affiliation': 'Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Cathryn M A', 'Initials': 'CMA', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, Scotland, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': ""University of Exeter Medical School, St. Luke's Campus, Exeter, UK.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gordon T', 'Initials': 'GT', 'LastName': 'Taylor', 'Affiliation': 'University of Plymouth, Plymouth, Devon, UK.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Belal', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Davies', 'Affiliation': 'Salisbury NHS Foundation Trust, Salisbury District Hospital, Salisbury, Wiltshire, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Dickinson', 'Affiliation': 'Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Foley', 'Affiliation': 'East and North Hertfordshire NHS Trust, Urology Department, Ashwell Block, Lister Hospital, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Foley', 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Royal Berkshire Hospital, Reading, Berkshire, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fulford', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Mohsen M', 'Initials': 'MM', 'LastName': 'Gammal', 'Affiliation': 'Southport and Ormskirk Hospital NHS Trust, Southport, Merseyside, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Garthwaite', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Mark R E', 'Initials': 'MRE', 'LastName': 'Harris', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Petre C', 'Initials': 'PC', 'LastName': 'Ilie', 'Affiliation': ""The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust, King's Lynn, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Urology Department, Taunton and Somerset NHS Foundation Trust, Musgrove Park Hospital, Taunton, Somerset, UK.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Sabbagh', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, Tooting, London, UK.""}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Mason', 'Affiliation': 'Torbay and South Devon NHS Foundation Trust, Torbay Hospital, Torquay, UK.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'McLarty', 'Affiliation': 'Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Vibhash', 'Initials': 'V', 'LastName': 'Mishra', 'Affiliation': 'Royal Free London NHS Foundation Trust, Royal Free Hospital, London, UK.'}, {'ForeName': 'Jaswant', 'Initials': 'J', 'LastName': 'Mom', 'Affiliation': 'North Cumbria University Hospitals NHS Trust, West Cumberland Hospital, Hensingham, Whitehaven, Cumbria, UK.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Morley', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Natale', 'Affiliation': 'Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Tharani', 'Initials': 'T', 'LastName': 'Nitkunan', 'Affiliation': 'Epsom and St Helier University Hospitals NHS Trust, Carshalton, Surrey, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, High Heaton, Newcastle Upon Tyne, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Payne', 'Affiliation': 'Kettering General Hospital NHS Foundation Trust, Kettering, Northants, UK.'}, {'ForeName': 'Tina G', 'Initials': 'TG', 'LastName': 'Rashid', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Saeb-Parsy', 'Affiliation': 'Urology Department, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Sarb S', 'Initials': 'SS', 'LastName': 'Sandhu', 'Affiliation': 'Kingston Hospital NHS Foundation Trust, Surrey, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Simoes', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Kent and Canterbury Hospital, Canterbury, Kent, UK.'}, {'ForeName': 'Gurpreet', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Southport and Ormskirk Hospital NHS Trust, Southport, Merseyside, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Nuffield Department of Surgical Sciences, Oxford University, Headington, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Headington, Oxford, UK.'}, {'ForeName': 'Heidi V', 'Initials': 'HV', 'LastName': 'Tempest', 'Affiliation': 'Nuffield Department of Surgical Sciences, Oxford University, Headington, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Headington, Oxford, UK.'}, {'ForeName': 'Srinivasa', 'Initials': 'S', 'LastName': 'Viswanath', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Roger M H', 'Initials': 'RMH', 'LastName': 'Walker', 'Affiliation': 'Epsom and St Helier University Hospitals NHS Trust, Carshalton, Surrey, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead Hospital, Bristol, UK. Electronic address: marcus.drake@bui.ac.uk.'}]",European urology focus,['10.1016/j.euf.2019.04.006']
871,31067089,An mHealth SMS intervention on Postpartum Contraceptive Use Among Women and Couples in Kenya: A Randomized Controlled Trial.,"Objectives. To assess the effect of 2-way short message service (SMS) with a nurse on postpartum contraceptive use among individual women and couples. Methods. From 2016 to 2017, we conducted a randomized controlled trial at 2 public hospitals in western Kenya. We assigned eligible pregnant women to receive 2-way SMS with a nurse or no SMS, with the option to include male partners. We delivered automated family planning-focused SMS messages weekly until 6 months postpartum. Women and men receiving SMS could interact with nurses via SMS. In intention-to-treat analysis, we compared highly effective contraceptive (HEC) use at 6 months postpartum between groups using the χ 2 test. We used Poisson regression in adjusted analysis. Results. We randomized 260 women to 2-way SMS or control, and we enrolled 103 male partners. At 6 months postpartum, 69.9% women receiving SMS reported HEC use, compared with 57.4% in control (relative risk = 1.22; 95% confidence interval [CI] = 1.01, 1.47; P = .04). In analysis adjusted for baseline demographic differences, the adjusted relative risk for HEC use in the SMS group was 1.26 (95% CI = 1.04, 1.52; P = .02). Conclusions. Two-way SMS with a nurse, including optional male participation, increased postpartum contraceptive use. Trial Registration. ClinicalTrials.gov; identifier: NCT02781714.",2019,"At 6 months postpartum, 69.9% women receiving SMS reported HEC use, compared with 57.4% in control (relative risk = 1.22; 95% confidence interval [CI] = 1.01, 1.47; P = .04).","['260 women to 2-way SMS or control, and we enrolled 103 male partners', 'Women and men receiving SMS could interact with nurses via SMS', 'individual women and couples', 'eligible pregnant women to receive 2-way SMS with a nurse or no SMS, with the option to include male partners', 'Women and Couples in Kenya', '2 public hospitals in western Kenya']","['mHealth SMS intervention', '2-way short message service (SMS']",['Postpartum Contraceptive Use'],"[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3178909'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",260.0,0.308138,"At 6 months postpartum, 69.9% women receiving SMS reported HEC use, compared with 57.4% in control (relative risk = 1.22; 95% confidence interval [CI] = 1.01, 1.47; P = .04).","[{'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Harrington', 'Affiliation': 'Elizabeth K. Harrington and Jennifer A. Unger are with the Department of Obstetrics & Gynecology, University of Washington, Seattle. Alison L. Drake, Keshet Ronen, Grace John-Stewart, and Jennifer A. Unger are with the Department of Global Health, University of Washington, Seattle. Grace John-Stewart is also with the Departments of Medicine, Pediatrics, and Epidemiology, University of Washington, Seattle. Alfred O. Osoti is with the University of Nairobi, Nairobi, Kenya. Daniel Matemo and John Kinuthia are with the Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Drake', 'Affiliation': 'Elizabeth K. Harrington and Jennifer A. Unger are with the Department of Obstetrics & Gynecology, University of Washington, Seattle. Alison L. Drake, Keshet Ronen, Grace John-Stewart, and Jennifer A. Unger are with the Department of Global Health, University of Washington, Seattle. Grace John-Stewart is also with the Departments of Medicine, Pediatrics, and Epidemiology, University of Washington, Seattle. Alfred O. Osoti is with the University of Nairobi, Nairobi, Kenya. Daniel Matemo and John Kinuthia are with the Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Matemo', 'Affiliation': 'Elizabeth K. Harrington and Jennifer A. Unger are with the Department of Obstetrics & Gynecology, University of Washington, Seattle. Alison L. Drake, Keshet Ronen, Grace John-Stewart, and Jennifer A. Unger are with the Department of Global Health, University of Washington, Seattle. Grace John-Stewart is also with the Departments of Medicine, Pediatrics, and Epidemiology, University of Washington, Seattle. Alfred O. Osoti is with the University of Nairobi, Nairobi, Kenya. Daniel Matemo and John Kinuthia are with the Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Keshet', 'Initials': 'K', 'LastName': 'Ronen', 'Affiliation': 'Elizabeth K. Harrington and Jennifer A. Unger are with the Department of Obstetrics & Gynecology, University of Washington, Seattle. Alison L. Drake, Keshet Ronen, Grace John-Stewart, and Jennifer A. Unger are with the Department of Global Health, University of Washington, Seattle. Grace John-Stewart is also with the Departments of Medicine, Pediatrics, and Epidemiology, University of Washington, Seattle. Alfred O. Osoti is with the University of Nairobi, Nairobi, Kenya. Daniel Matemo and John Kinuthia are with the Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Alfred O', 'Initials': 'AO', 'LastName': 'Osoti', 'Affiliation': 'Elizabeth K. Harrington and Jennifer A. Unger are with the Department of Obstetrics & Gynecology, University of Washington, Seattle. Alison L. Drake, Keshet Ronen, Grace John-Stewart, and Jennifer A. Unger are with the Department of Global Health, University of Washington, Seattle. Grace John-Stewart is also with the Departments of Medicine, Pediatrics, and Epidemiology, University of Washington, Seattle. Alfred O. Osoti is with the University of Nairobi, Nairobi, Kenya. Daniel Matemo and John Kinuthia are with the Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Elizabeth K. Harrington and Jennifer A. Unger are with the Department of Obstetrics & Gynecology, University of Washington, Seattle. Alison L. Drake, Keshet Ronen, Grace John-Stewart, and Jennifer A. Unger are with the Department of Global Health, University of Washington, Seattle. Grace John-Stewart is also with the Departments of Medicine, Pediatrics, and Epidemiology, University of Washington, Seattle. Alfred O. Osoti is with the University of Nairobi, Nairobi, Kenya. Daniel Matemo and John Kinuthia are with the Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Elizabeth K. Harrington and Jennifer A. Unger are with the Department of Obstetrics & Gynecology, University of Washington, Seattle. Alison L. Drake, Keshet Ronen, Grace John-Stewart, and Jennifer A. Unger are with the Department of Global Health, University of Washington, Seattle. Grace John-Stewart is also with the Departments of Medicine, Pediatrics, and Epidemiology, University of Washington, Seattle. Alfred O. Osoti is with the University of Nairobi, Nairobi, Kenya. Daniel Matemo and John Kinuthia are with the Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Unger', 'Affiliation': 'Elizabeth K. Harrington and Jennifer A. Unger are with the Department of Obstetrics & Gynecology, University of Washington, Seattle. Alison L. Drake, Keshet Ronen, Grace John-Stewart, and Jennifer A. Unger are with the Department of Global Health, University of Washington, Seattle. Grace John-Stewart is also with the Departments of Medicine, Pediatrics, and Epidemiology, University of Washington, Seattle. Alfred O. Osoti is with the University of Nairobi, Nairobi, Kenya. Daniel Matemo and John Kinuthia are with the Kenyatta National Hospital, Nairobi, Kenya.'}]",American journal of public health,['10.2105/AJPH.2019.305051']
872,31022003,Feasibility and Outcomes of an Exercise Intervention for Chemotherapy-Induced Heart Failure.,"PURPOSE
Cancer treatment-related heart failure (HF) is an emerging health concern, as the number of survivors is increasing rapidly, and cardiac health issues are a leading cause of mortality in this population. While there is general evidence for the efficacy of exercise rehabilitation interventions, more research is needed on exercise rehabilitation interventions for patients specifically with treatment-induced HF and whether such interventions are safe and well-accepted. This study provides feasibility and health outcomes of a pilot exercise intervention for cancer survivors with chemotherapy-induced HF.
METHODS
Twenty-five participants were randomized to a clinic-based exercise intervention or a wait-list control group or, alternatively, allowed to enroll in a home-based exercise intervention if they declined the randomized study. For purposes of analysis, both types of exercise programs were combined into a single intervention group. Repeated-measures analysis of variance was conducted to assess for significant time and treatment group main effects separately and time × treatment group interaction effects.
RESULTS
Significant improvements in maximum oxygen uptake ((Equation is included in full-text article.)O2max) were observed in the intervention group. Intervention satisfaction and adherence were high for both clinic- and home-based interventions, with no reported serious adverse events. Enrollment was initially low for the clinic-based intervention, necessitating the addition of the home-based program as an intervention alternative.
CONCLUSIONS
Results suggest that exercise rehabilitation interventions are feasible in terms of safety, retention, and satisfaction and have the potential to improve (Equation is included in full-text article.)O2max. To maximize adherence and benefits while minimizing participant burden, an ideal intervention may incorporate elements of both clinic-based supervised exercise sessions and a home-based program.",2019,"Intervention satisfaction and adherence were high for both clinic- and home-based interventions, with no reported serious adverse events.","['Twenty-five participants', 'cancer survivors with chemotherapy-induced HF']","['pilot exercise intervention', 'clinic-based exercise intervention or a wait-list control group or, alternatively, allowed to enroll in a home-based exercise intervention', 'exercise rehabilitation interventions', 'Exercise Intervention']","['safety, retention, and satisfaction', 'maximum oxygen uptake', 'Intervention satisfaction and adherence']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake (observable entity)'}]",25.0,0.063477,"Intervention satisfaction and adherence were high for both clinic- and home-based interventions, with no reported serious adverse events.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Tsai', 'Affiliation': 'Department of Health Promotion & Behavioral Sciences, The University of Texas School of Public Health, Houston (Mr Tsai); Department of Behavioral Science (Mr Tsai, Ms Harrison, and Dr Basen-Engquist), Department of Cardiology, Division of Internal Medicine (Drs Mouhayar and Durand), Department of Biostatistics (Dr Song), Department of Nursing (Dr Fadol), and Clinical Research Support Center (Ms Massey), The University of Texas MD Anderson Cancer Center, Houston; and Cardiovascular Division, Washington University School of Medicine in St Louis, St Louis, Missouri (Dr Lenihan).'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Mouhayar', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lenihan', 'Affiliation': ''}, {'ForeName': 'Jaejoon', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Jean-Bernard', 'Initials': 'JB', 'LastName': 'Durand', 'Affiliation': ''}, {'ForeName': 'Anecita', 'Initials': 'A', 'LastName': 'Fadol', 'Affiliation': ''}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Massey', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basen-Engquist', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000388']
873,30724853,International survey of patients undergoing percutaneous coronary intervention and their attitudes toward pharmacogenetic testing.,"OBJECTIVE
To evaluate perceptions toward pharmacogenetic testing of patients undergoing percutaneous coronary intervention (PCI) who are prescribed dual antiplatelet therapy (DAPT) and whether geographical differences in these perceptions exist.
PARTICIPANTS AND METHODS
TAILOR-PCI is the largest genotype-based cardiovascular clinical trial randomizing participants to conventional DAPT or prospective genotyping-guided DAPT. Enrolled patients completed surveys before and 6 months after randomization.
RESULTS
A total of 1327 patients completed baseline surveys of whom 28, 29, and 43% were from Korea, Canada and the USA, respectively. Most patients (77%) valued identifying pharmacogenetic variants; however, fewer Koreans (44%) as compared with Canadians (91%) and USA (89%) patients identified pharmacogenetics as being important (P<0.001). After adjusting for age, sex, and country, those who were confident in their ability to understand genetic information were significantly more likely to value identifying pharmacogenetic variants (odds ratio: 30.0; 95% confidence interval: 20.5-43.8). Only 21% of Koreans, as opposed to 86 and 77% of patients in Canada and USA, respectively, were confident in their ability to understand genetic information (P<0.001).
CONCLUSION
Although genetically mediated clopidogrel resistance is more prevalent amongst Asians, Koreans undergoing PCI identified pharmacogenetic variants as less important to their healthcare, likely related to their lack of confidence in their ability to understand genetic information. To enable successful implementation of pharmacogenetic testing on a global scale, the possibility of international population differences in perceptions should be considered.",2019,"After adjusting for age, sex, and country, those who were confident in their ability to understand genetic information were significantly more likely to value identifying pharmacogenetic variants (odds ratio: 30.0; 95% confidence interval: 20.5-43.8).","['1327 patients completed baseline surveys of whom 28, 29, and 43% were from Korea, Canada and the USA, respectively', 'patients undergoing percutaneous coronary intervention and their attitudes toward pharmacogenetic testing', 'TAILOR-PCI is the largest genotype-based cardiovascular clinical trial randomizing participants to conventional DAPT or prospective genotyping-guided DAPT', 'patients undergoing']","['percutaneous coronary intervention (PCI', 'dual antiplatelet therapy (DAPT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Testing'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]",[],1327.0,0.154449,"After adjusting for age, sex, and country, those who were confident in their ability to understand genetic information were significantly more likely to value identifying pharmacogenetic variants (odds ratio: 30.0; 95% confidence interval: 20.5-43.8).","[{'ForeName': 'Naveen L', 'Initials': 'NL', 'LastName': 'Pereira', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'So', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa.'}, {'ForeName': 'Jang-Ho', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Department of Interventional Cardiology, Internal Medicine, Division of Cardiology, Konyang University, Nonsan.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Chavez', 'Affiliation': 'Department of Cardiology, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiology, Heart Research Center, Chonnam National University, Gwangju.'}, {'ForeName': 'Sang Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Chung-Ang University Hospital, Seoul, South Korea.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Madan', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': ""Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Fearghas', 'Initials': 'F', 'LastName': ""O'Cochlain"", 'Affiliation': 'Department of Medicine, Mayo Clinic Health System, Eau Claire Hospital Inc., Eau Claire, Wisconsin.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pauley', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Lennon', 'Affiliation': 'Department of Health Sciences Research.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences Research.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Atherothrombosis and Coronary Artrey Disease Department, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Linnea M', 'Initials': 'LM', 'LastName': 'Baudhuin', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'Bell', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Department of Cardiovascular Medicine.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': ""Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Verghese', 'Initials': 'V', 'LastName': 'Mathew', 'Affiliation': 'Department of Medicine, Loyola University, Mayowood, Illinois, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farkouh', 'Affiliation': ""Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Charanjit S', 'Initials': 'CS', 'LastName': 'Rihal', 'Affiliation': 'Department of Cardiovascular Medicine.'}]",Pharmacogenetics and genomics,['10.1097/FPC.0000000000000368']
874,30681719,Predicting asymptomatic cervical dilation in pregnant patients with short mid-trimester cervical length: A secondary analysis of a randomized controlled trial.,"INTRODUCTION
Second trimester asymptomatic cervical dilation is a significant risk factor for early preterm birth. The objective of this study is to evaluate whether transvaginal ultrasound cervical length (CL) predicts asymptomatic cervical dilation on physical exam in women with short cervix (CL ≤25 mm) and no prior preterm birth.
MATERIAL AND METHODS
Secondary analysis of a randomized trial on pessary in asymptomatic singletons without prior preterm birth diagnosed with CL ≤25 mm between 18 +0/7 and 23 +6/7 weeks. Participants had transvaginal ultrasound and physical cervical exam and were randomized to pessary or no pessary with all patients with cervical length ≤20 mm offered vaginal progesterone. The primary outcome was to determine whether CL was predictive of asymptomatic physical cervical dilation ≥1 cm using receiver operating characteristic curve.
RESULTS
In all, 119 women were included. Based on receiver operating characteristic curve, CL ≤11 mm was best predictive of cervical dilation ≥1 cm, with 75% sensitivity, 80% specificity, and area under the curve 0.73 (0.55-0.91), P = 0.009. Cervical length ≤11 mm had increased incidence of cervical dilation ≥1 cm on physical exam (30% vs 3%, odds ratio 12.29 (3.05-49.37) P < 0.001) with a negative predictive value of 97%. Patients with ≥1 cm dilation had increased preterm birth <37 weeks (75% vs 39%, P = 0.03) compared to those not dilated. Women with a CL ≤11 mm had increased preterm birth <37 weeks (77% vs 31%, P < 0.001), preterm birth <34 weeks (63% vs 22%, P < 0.001), and lower birthweight (1552 ± 1047 vs 2560 ± 1072 g, P < 0.001) compared to women with CL >11 mm.
CONCLUSIONS
Among singletons without prior preterm birth diagnosed with short cervix (≤25 mm), CL ≤11 mm may identify a subgroup of patients at high risk for asymptomatic cervical dilation and poor perinatal outcome. Physical exam should be considered and adjunctive preterm birth prevention measures should be studied in singletons with CL ≤11 mm.",2019,"cm dilation had increased preterm birth <37 weeks (75% vs 39%, P = 0.03) compared to those not dilated.","['pregnant patients with short mid-trimester cervical length', 'Patients with ≥1', '1047 vs 2560\xa0±\xa01072', 'asymptomatic singletons without prior preterm birth diagnosed with CL ≤25\xa0mm between 18 +0/7 and 23 +6/7 \xa0weeks', '119 women were included', 'Participants had transvaginal ultrasound and physical cervical exam', 'women with short cervix (CL ≤25\xa0mm) and no prior preterm birth']","['pessary or no pessary with all patients with cervical length ≤20\xa0mm offered vaginal progesterone', 'transvaginal ultrasound cervical length (CL', 'CL']","['incidence of cervical dilation ≥1\xa0cm on physical exam', 'preterm birth', 'asymptomatic cervical dilation', 'asymptomatic physical cervical dilation']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0032982', 'cui_str': 'Pregnancy Trimesters'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}]","[{'cui': 'C0031246', 'cui_str': 'Pessaries'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}]",119.0,0.395901,"cm dilation had increased preterm birth <37 weeks (75% vs 39%, P = 0.03) compared to those not dilated.","[{'ForeName': 'Rupsa C', 'Initials': 'RC', 'LastName': 'Boelig', 'Affiliation': 'Division of Maternal Fetal Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Dugoff', 'Affiliation': 'Division of Maternal Fetal Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Roman', 'Affiliation': 'Division of Maternal Fetal Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Berghella', 'Affiliation': 'Division of Maternal Fetal Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Ludmir', 'Affiliation': 'Division of Maternal Fetal Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13545']
875,31133585,Evidence-based intervention to reduce avoidable hospital admissions in care home residents (the Better Health in Residents in Care Homes (BHiRCH) study): protocol for a pilot cluster randomised trial.,"INTRODUCTION
Acute hospital admission is distressing for care home residents. Ambulatory care sensitive conditions, such as respiratory and urinary tract infections, are conditions that can cause unplanned hospital admission but may have been avoidable with timely detection and intervention in the community. The Better Health in Residents in Care Homes (BHiRCH) programme has feasibility tested and will pilot a multicomponent intervention to reduce these avoidable hospital admissions. The BHiRCH intervention comprises an early warning tool for noting changes in resident health, a care pathway (clinical guidance and decision support system) and a structured method for communicating with primary care, adapted for use in the care home. We use practice development champions to support implementation and embed changes in care.
METHODS AND ANALYSIS
Cluster randomised pilot trial to test study procedures and indicate whether a further definitive trial is warranted. Fourteen care homes with nursing (nursing homes) will be randomly allocated to intervention (delivered at nursing home level) or control groups. Two nurses from each home become Practice Development Champions trained to implement the intervention, supported by a practice development support group. Data will be collected for 3 months preintervention, monthly during the 12-month intervention and 1 month after. Individual-level data includes resident, care partner and staff demographics, resident functional status, service use and quality of life (for health economic analysis) and the extent to which staff perceive the organisation supports person centred care. System-level data includes primary and secondary health services contacts (ie, general practitioner and hospital admissions). Process evaluation assesses intervention acceptability, feasibility, fidelity, ease of implementation in practice and study procedures (ie, consent and recruitment rates).
ETHICS AND DISSEMINATION
Approved by Research Ethics Committee and the UK Health Research Authority. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media (eg, Twitter).
TRIAL REGISTRATION NUMBER
ISRCTN74109734; Pre-results.",2019,"Ambulatory care sensitive conditions, such as respiratory and urinary tract infections, are conditions that can cause unplanned hospital admission but may have been avoidable with timely detection and intervention in the community.","['care home residents', 'care home residents (the Better Health in Residents in Care Homes (BHiRCH) study', 'Fourteen care homes with nursing (nursing homes', 'Residents in Care Homes (BHiRCH) programme']","['Evidence-based intervention', 'BHiRCH intervention']","['intervention acceptability, feasibility, fidelity, ease of implementation in practice and study procedures (ie, consent and recruitment rates', 'avoidable hospital admissions']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",14.0,0.0581889,"Ambulatory care sensitive conditions, such as respiratory and urinary tract infections, are conditions that can cause unplanned hospital admission but may have been avoidable with timely detection and intervention in the community.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Sampson', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Feast', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Blighe', 'Affiliation': 'Centre for Applied Dementia Studies, University of Bradford, Bradford, West Yorkshire, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Froggatt', 'Affiliation': 'International Observatory on End of Life Care, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Dept of Primary Care and Population Health and PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Research Dept of Primary Care and Population Health and PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'McCormack', 'Affiliation': 'School of Health Studies, Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Nurock', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Panca', 'Affiliation': 'Research Dept of Primary Care and Population Health and PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Centre for Applied Dementia Studies, University of Bradford, Bradford, West Yorkshire, UK.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Rait', 'Affiliation': 'Research Dept of Primary Care and Population Health and PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Robinson', 'Affiliation': 'Institute for Health and Society and Newcastle University Institute for Ageing, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Woodward-Carlton', 'Affiliation': 'Centre for Applied Dementia Studies, University of Bradford, Bradford, West Yorkshire, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Institute for Health Research, University of Leeds, Bradford, UK.'}, {'ForeName': 'Murna', 'Initials': 'M', 'LastName': 'Downs', 'Affiliation': 'Centre for Applied Dementia Studies, University of Bradford, Bradford, West Yorkshire, UK.'}]",BMJ open,['10.1136/bmjopen-2018-026510']
876,31088893,Food Insecurity During Pregnancy and Breastfeeding by Low-Income Hispanic Mothers.,"BACKGROUND AND OBJECTIVES
Pregnancy, infancy, and toddlerhood are sensitive times in which families are particularly vulnerable to household food insecurity and when disparities in child obesity emerge. Understanding obesity-promoting infant-feeding beliefs, styles, and practices in the context of food insecurity could better inform both food insecurity and child obesity prevention interventions and policy guidelines.
METHODS
We performed purposive sampling of low-income Hispanic mothers ( n = 100) with infants in the first 2 years of life, all of whom were participants in a randomized controlled trial of an early child obesity prevention intervention called the Starting Early Program. Bilingual English-Spanish interviewers conducted semistructured qualitative interviews, which were audio recorded, transcribed, and translated. By using the constant comparative method, transcripts were coded through an iterative process of textual analysis until thematic saturation was reached.
RESULTS
Three key themes emerged: (1) contributors to financial strain included difficulty meeting basic needs, job instability, and high vulnerability specific to pregnancy, infancy, and immigration status; (2) effects on infant feeding included decreased breastfeeding due to perceived poor maternal diet, high stress, and limiting of healthy foods; and (3) coping strategies included both home- and community-level strategies.
CONCLUSIONS
Stakeholders in programs and policies to prevent poverty-related disparities in child obesity should consider and address the broader context by which food insecurity is associated with contributing beliefs, styles, and practices. Potential strategies include addressing misconceptions about maternal diet and breast milk adequacy, stress management, building social support networks, and connecting to supplemental nutrition assistance programs.",2019,"We performed purposive sampling of low-income Hispanic mothers ( n = 100) with infants in the first 2 years of life, all of whom were participants in a randomized controlled trial of an early child obesity prevention intervention called the Starting Early Program.","['low-income Hispanic mothers ( n = 100) with infants in the first 2 years of life, all of whom were participants']","['Food Insecurity', 'early child obesity prevention intervention called the Starting Early Program']","['difficulty meeting basic needs, job instability, and high vulnerability specific to pregnancy, infancy, and immigration status; (2) effects on infant feeding included decreased breastfeeding due to perceived poor maternal diet, high stress, and limiting of healthy foods; and (3) coping strategies included both home- and community-level strategies']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0020942', 'cui_str': 'Immigration'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",100.0,0.0242997,"We performed purposive sampling of low-income Hispanic mothers ( n = 100) with infants in the first 2 years of life, all of whom were participants in a randomized controlled trial of an early child obesity prevention intervention called the Starting Early Program.","[{'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Divisions of General Pediatrics and rachel.gross@nyulangone.org.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Developmental and Behavioral Pediatrics, Department of Pediatrics, School of Medicine, New York University, New York, New York.'}, {'ForeName': 'Mayela M', 'Initials': 'MM', 'LastName': 'Arana', 'Affiliation': 'Divisions of General Pediatrics and.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Divisions of General Pediatrics and.'}]",Pediatrics,['10.1542/peds.2018-4113']
877,29709061,Fidelity Failures in Brief Strategic Family Therapy for Adolescent Drug Abuse: A Clinical Analysis.,"As evidence-based family treatments for adolescent substance use and conduct problems gain traction, cutting edge research moves beyond randomized efficacy trials to address questions such as how these treatments work and how best to disseminate them to community settings. A key factor in effective dissemination is treatment fidelity, which refers to implementing an intervention in a manner consistent with an established manual. While most fidelity research is quantitative, this study offers a qualitative clinical analysis of fidelity failures in a large, multisite effectiveness trial of Brief Strategic Family Therapy (BSFT) for adolescent drug abuse, where BSFT developers trained community therapists to administer this intervention in their own agencies. Using case notes and video recordings of therapy sessions, an independent expert panel first rated 103 cases on quantitative fidelity scales grounded in the BSFT manual and the broader structural-strategic framework that informs BSFT intervention. Because fidelity was generally low, the panel reviewed all cases qualitatively to identify emergent types or categories of fidelity failure. Ten categories of failures emerged, characterized by therapist omissions (e.g., failure to engage key family members, failure to think in threes) and commissions (e.g., off-model, nonsystemic formulations/interventions). Of these, ""failure to think in threes"" appeared basic and particularly problematic, reflecting the central place of this idea in structural theory and therapy. Although subject to possible bias, our observations highlight likely stumbling blocks in exporting a complex family treatment like BSFT to community settings. These findings also underscore the importance of treatment fidelity in family therapy research.",2019,"Ten categories of failures emerged, characterized by therapist omissions (e.g., failure to engage key family members, failure to think in threes) and commissions (e.g., off-model, nonsystemic formulations/interventions).",['Adolescent Drug Abuse'],['Brief Strategic Family Therapy (BSFT'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}]",[],103.0,0.0419953,"Ten categories of failures emerged, characterized by therapist omissions (e.g., failure to engage key family members, failure to think in threes) and commissions (e.g., off-model, nonsystemic formulations/interventions).","[{'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Lebensohn-Chialvo', 'Affiliation': 'Department of Counseling and Marital and Family Therapy, University of San Diego, San Diego, CA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rohrbaugh', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Brant P', 'Initials': 'BP', 'LastName': 'Hasler', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, George Washington University, Washington, DC.'}]",Family process,['10.1111/famp.12366']
878,29710208,Comparison Between Patient-Perceived Voice Changes and Quantitative Voice Measures in the First Postoperative Year After Thyroidectomy: A Secondary Analysis of a Randomized Clinical Trial.,"Importance
Voice changes after thyroidectomy are typically attributed to recurrent laryngeal nerve injury. However, most postoperative voice changes occur in the absence of clinically evident vocal fold paralysis. To date, no study has compared the prevalence, duration, and consequences of voice-related disability from the patient perspective with use of quantitative vocal measures.
Objectives
To assess the quality-of-life consequences of postthyroidectomy voice change from the perspective of patients with thyroid cancer and to compare patient-perceived voice changes with changes in quantitative vocal variables at 5 time points in the first postoperative year.
Design, Setting, and Participants
This prospective mixed methods observational study within a randomized clinical trial occurred at the University of Wisconsin Hospital and Clinics. Participants were 42 patients with clinically node-negative papillary thyroid cancer without a preexisting vocal cord paralysis who were recruited and enrolled from outpatient clinics between June 6, 2014, and March 6, 2017, as part of the ongoing randomized clinical trial.
Intervention
Total thyroidectomy.
Main Outcomes and Measures
Semistructured interviews, symptom prevalence, and instrumental voice evaluations (laryngoscopy, phonation threshold pressure, Dysphonia Severity Index, and Voice Handicap Index) occurred at baseline (n = 42) and 2-week (n = 42), 6-week (n = 39), 6-month (n = 35), and 1-year (n = 30) postoperative time points.
Results
Participants had a mean age of 48 years (interquartile range, 38-58 years; age range, 22-70 years) and were mostly female (74% [31 of 42]) and of white race/ethnicity (98% [41 of 42]). Impaired communication was the primary theme derived from patient interviews from before thyroidectomy to after thyroidectomy. Voice changes were perceived by 24 participants at 2 weeks after thyroidectomy. After surgery, voice symptoms were prevalent and persisted for 50% (21 of 42) of participants out to at least 1 year of follow-up. Quantitative vocal perturbations were detected in the Dysphonia Severity Index and Voice Handicap Index at the 2-week follow-up but returned to baseline levels by the 6-week follow-up visit.
Conclusions and Relevance
Voice changes are common after surgery for papillary thyroid cancer and affect quality of life for many patients out to 1 year of follow-up. Directly querying patients about postoperative voice changes and questioning whether commonly used aerodynamic and acoustic variables detect meaningful voice changes are important in identifying patients whose quality of life has been affected by postthyroidectomy dysphonia.
Trial Registration
ClinicalTrials.gov Identifier: NCT02138214.",2018,"Quantitative vocal perturbations were detected in the Dysphonia Severity Index and Voice Handicap Index at the 2-week follow-up but returned to baseline levels by the 6-week follow-up visit.
","['Results\n\n\nParticipants had a mean age of 48 years (interquartile range, 38-58 years; age range, 22-70 years) and were mostly female (74% [31 of 42]) and of white race/ethnicity (98% [41 of 42', 'Participants were 42 patients with clinically node-negative papillary thyroid cancer without a preexisting vocal cord paralysis who were recruited and enrolled from outpatient clinics between June 6, 2014, and March 6, 2017, as part of the ongoing randomized clinical trial', 'patients with thyroid cancer', 'University of Wisconsin Hospital and Clinics']","['Thyroidectomy', 'Intervention\n\n\nTotal thyroidectomy']","['Voice changes', 'Quantitative vocal perturbations', 'Voice Changes and Quantitative Voice Measures', 'quality of life', 'voice symptoms', 'Dysphonia Severity Index and Voice Handicap Index', 'Measures\n\n\nSemistructured interviews, symptom prevalence, and instrumental voice evaluations (laryngoscopy, phonation threshold pressure, Dysphonia Severity Index, and Voice Handicap Index']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0238463', 'cui_str': 'Thyroid Cancer, Papillary'}, {'cui': 'C0042928', 'cui_str': 'Total Vocal Cord Paralysis'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy (procedure)'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0031577', 'cui_str': 'Phonation'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",42.0,0.118793,"Quantitative vocal perturbations were detected in the Dysphonia Severity Index and Voice Handicap Index at the 2-week follow-up but returned to baseline levels by the 6-week follow-up visit.
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Kletzien', 'Affiliation': 'Division of Otolaryngology-Head and Neck Cancer, Department of Surgery, School of Medicine and Public Health, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Cameron L', 'Initials': 'CL', 'LastName': 'Macdonald', 'Affiliation': 'Qualitative Health Research Consultants, Madison, Wisconsin.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Orne', 'Affiliation': 'Qualitative Health Research Consultants, Madison, Wisconsin.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Francis', 'Affiliation': 'Division of Otolaryngology-Head and Neck Cancer, Department of Surgery, School of Medicine and Public Health, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Leverson', 'Affiliation': 'Division of Otolaryngology-Head and Neck Cancer, Department of Surgery, School of Medicine and Public Health, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wendt', 'Affiliation': 'Division of Endocrine Surgery, Department of Surgery, School of Medicine and Public Health, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Sippel', 'Affiliation': 'Division of Endocrine Surgery, Department of Surgery, School of Medicine and Public Health, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Nadine P', 'Initials': 'NP', 'LastName': 'Connor', 'Affiliation': 'Division of Otolaryngology-Head and Neck Cancer, Department of Surgery, School of Medicine and Public Health, University of Wisconsin-Madison, Madison.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2018.0309']
879,31009834,Veterans with PTSD and comorbid substance use disorders: Does single versus poly-substance use disorder affect treatment outcomes?,"INTRODUCTION
Substance use disorders (SUD) frequently co-occur with posttraumatic stress disorder (PTSD). Little is known, however, about how individuals with a single SUD diagnosis (relating to only one substance) compare to individuals with poly-SUD diagnoses (relating to more than one substance) on substance use and PTSD treatment outcomes. To address this gap in the literature, we utilized data from a larger study investigating a 12-week integrated, exposure-based treatment (i.e., Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure, or COPE) to examine treatment outcomes by single vs. poly-SUD status.
METHOD
Participants were 54 Veterans (92.6% male, average age = 39.72) categorized as having single SUD (n = 39) or poly-SUD (n = 15). T-tests characterized group differences in baseline demographics and presenting symptomatology. Multilevel models examined differences in treatment trajectories between participants with single vs. poly-SUD.
RESULTS
Groups did not differ on baseline frequency of substance use, PTSD symptoms, or treatment retention; however, individuals with poly-SUD evidenced greater reductions in percent days using substances than individuals with a single SUD, and individuals with a single SUD had greater reductions in PTSD symptoms than individuals with poly-SUD over the course of treatment.
DISCUSSION
The findings from this exploratory study suggest that Veterans with PTSD and co-occurring poly-SUD, as compared to a single-SUD, may experience greater improvement in substance use but less improvement in PTSD symptoms during integrated treatment. Future research should identify ways to enhance treatment outcomes for individuals with poly-SUD, and to better understand mechanisms of change for this population.",2019,"RESULTS
Groups did not differ on baseline frequency of substance use, PTSD symptoms, or treatment retention; however, individuals with poly-SUD evidenced greater reductions in percent days using substances than individuals with a single SUD, and individuals with a single SUD had greater reductions in PTSD symptoms than individuals with poly-SUD over the course of treatment.
","['Veterans with PTSD and comorbid substance use disorders', 'participants with single vs. poly-SUD', 'Participants were 54 Veterans (92.6% male, average age\u2009=\u200939.72) categorized as having single SUD (n\u2009=\u200939) or poly-SUD (n\u2009=\u200915', 'Veterans with PTSD and co-occurring poly-SUD', 'individuals with poly-SUD']",[],"['PTSD symptoms', 'baseline frequency of substance use, PTSD symptoms, or treatment retention']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",54.0,0.0168498,"RESULTS
Groups did not differ on baseline frequency of substance use, PTSD symptoms, or treatment retention; however, individuals with poly-SUD evidenced greater reductions in percent days using substances than individuals with a single SUD, and individuals with a single SUD had greater reductions in PTSD symptoms than individuals with poly-SUD over the course of treatment.
","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Jeffirs', 'Affiliation': 'Department of Behavioral Sciences and Psychiatry, Division of Addiction Sciences, Medical University of South Carolina, 5 Charleston Center Dr., Suite 151, Charleston, SC, 29401 USA. Electronic address: jeffirs@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Behavioral Sciences and Psychiatry, Division of Addiction Sciences, Medical University of South Carolina, 5 Charleston Center Dr., Suite 151, Charleston, SC, 29401 USA.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Behavioral Sciences and Psychiatry, Division of Addiction Sciences, Medical University of South Carolina, 5 Charleston Center Dr., Suite 151, Charleston, SC, 29401 USA.'}, {'ForeName': 'Therese K', 'Initials': 'TK', 'LastName': 'Killeen', 'Affiliation': 'Department of Behavioral Sciences and Psychiatry, Division of Addiction Sciences, Medical University of South Carolina, 5 Charleston Center Dr., Suite 151, Charleston, SC, 29401 USA.'}, {'ForeName': 'Taylor F', 'Initials': 'TF', 'LastName': 'Laffey', 'Affiliation': 'Department of Behavioral Sciences and Psychiatry, Division of Addiction Sciences, Medical University of South Carolina, 5 Charleston Center Dr., Suite 151, Charleston, SC, 29401 USA.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Behavioral Sciences and Psychiatry, Division of Addiction Sciences, Medical University of South Carolina, 5 Charleston Center Dr., Suite 151, Charleston, SC, 29401 USA; Ralph H. Johnson VA Medical Center, 109 Bee St., Charleston, SC, 29401 USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.04.001']
880,31110092,"Sarcome-13/OS2016 trial protocol: a multicentre, randomised, open-label, phase II trial of mifamurtide combined with postoperative chemotherapy for patients with newly diagnosed high-risk osteosarcoma.","INTRODUCTION
The controversial results on the mifamurtide efficacy associated with chemotherapy, issued from the American INT-0133-study, in localised osteosarcomas, and the underpowered analysis performed separately in metastatic patients, should be clarified to homogenise international use of this promising drug. The European Commission has granted a marketing authorisation to mifamurtide combined with postoperative chemotherapy in localised osteosarcomas but not in metastatic patients, while the Food and Drug Administration (FDA) has denied this authorisation.
METHODS AND ANALYSIS
Sarcome-13/OS2016 trial is a multicentre randomised open-label phase II trial evaluating the survival benefit of mifamurtide administered during 36 weeks in combination with postoperative chemotherapy versus chemotherapy alone, in patients >2 and ≤50 years with newly diagnosed high-risk localised or metastatic osteosarcoma. The main objective is to evaluate the impact on event-free survival (EFS) of mifamurtide on intention-to-treat population. The secondary objectives are to evaluate the impact of mifamurtide on overall survival, to evaluate the feasibility and toxicity of the planned treatment, to correlate biology/immunology with the mifamurtide efficacy/toxicity. With a total of 126 enrolled patients and 51 events, the power is 80% if mifamurtide is associated with an 18% improvement of the 3-year EFS (52%vs70%, equivalent to an HR=0.55), with a one-sided logrank test alpha=10%. As relevant historical data are available (aggregate treatment effect from the INT-0133 trial and individual data from the control group of the Sarcome-09/OS2006 trial), a Bayesian analysis is also planned.
ETHICS AND DISSEMINATION
This study was approved by the 'Comité de Protection des Personnes Ile de France I' (12/06/2018), complies with the Declaration of Helsinki and French laws and regulations, and follows the International Conference on Harmonisation E6 Guideline for Good Clinical Practice. The trial results, even if they are inconclusive, as well as biological ancillary studies will be presented at appropriate international congresses and published in international peer-review journals.
TRIAL REGISTRATION NUMBER
EudraCT 2017-001165-24, NCT03643133.",2019,"With a total of 126 enrolled patients and 51 events, the power is 80% if mifamurtide is associated with an 18% improvement of the 3-year EFS (52%vs70%, equivalent to an HR=0.55), with a one-sided logrank test alpha=10%.","['2\u2009and ≤50 years with newly diagnosed high-risk localised or metastatic osteosarcoma', '126 enrolled patients and 51 events', 'patients with newly diagnosed high-risk osteosarcoma', 'patients']","['postoperative chemotherapy versus chemotherapy alone', 'EudraCT', 'mifamurtide combined with postoperative chemotherapy']","['feasibility and toxicity', '3-year EFS', 'mifamurtide efficacy/toxicity', 'survival benefit of mifamurtide', 'overall survival']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0278512', 'cui_str': 'Metastatic osteosarcoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0029463', 'cui_str': 'Sarcoma, Osteogenic'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0129341', 'cui_str': 'muramylNAc-Ala-isoGln-Lys-tripeptide-PE'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0129341', 'cui_str': 'muramylNAc-Ala-isoGln-Lys-tripeptide-PE'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",126.0,0.169213,"With a total of 126 enrolled patients and 51 events, the power is 80% if mifamurtide is associated with an 18% improvement of the 3-year EFS (52%vs70%, equivalent to an HR=0.55), with a one-sided logrank test alpha=10%.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Brard', 'Affiliation': 'CESP, INSERM, Faculté de médecine, Université Paris-Sud, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Piperno-Neumann', 'Affiliation': 'Medical Oncology Department, Institut Curie, Paris, France.'}, {'ForeName': 'Jessy', 'Initials': 'J', 'LastName': 'Delaye', 'Affiliation': 'UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Brugières', 'Affiliation': 'Department of Childhood and Adolescent Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Hampson', 'Affiliation': 'Medicaland Pharmaceutical Statistics Research Unit, Departmentof Mathematics and Statistics, FyldeCollege, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Gwénaël', 'Initials': 'G', 'LastName': 'Le Teuff', 'Affiliation': 'CESP, INSERM, Faculté de médecine, Université Paris-Sud, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'CESP, INSERM, Faculté de médecine, Université Paris-Sud, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Gaspar', 'Affiliation': 'Department of Childhood and Adolescent Oncology, Gustave Roussy, Villejuif, France.'}]",BMJ open,['10.1136/bmjopen-2018-025877']
881,31095004,Brief Report: Cofactors of Mortality Among Hospitalized HIV-Infected Children Initiating Antiretroviral Therapy in Kenya.,"OBJECTIVES
Identifying factors associated with mortality among acutely ill HIV-infected children presenting with advanced HIV disease may help clinicians optimize care for those at highest risk of death.
DESIGN
Using data from a randomized controlled trial (NCT02063880), we determined baseline sociodemographic, clinical, and laboratory cofactors of mortality among HIV-infected children in Kenya.
METHODS
We enrolled hospitalized, HIV-infected, antiretroviral therapy-naive children (0-12 years), initiated antiretroviral therapy, and followed up them for 6 months. We used Cox proportional hazards regression to estimate hazard ratios (HRs) for death and 95% confidence intervals (CIs).
RESULTS
Of 181 enrolled children, 39 (22%) died. Common diagnoses at death were pneumonia or suspected pulmonary tuberculosis [23 (59%)] and gastroenteritis [7 (18%)]. Factors associated with mortality in univariate analysis included age <2 years [HR 3.08 (95% CI: 1.50 to 6.33)], orphaned or vulnerable child (OVC) [HR 2.05 (95% CI: 1.09 to 3.84)], weight-for-age Z score <-2 [HR 2.29 (95% CI: 1.05 to 5.00)], diagnosis of pneumonia with hypoxia [HR 5.25 (95% CI: 2.00 to 13.84)], oral thrush [HR 2.17 (95% CI: 1.15 to 4.09)], persistent diarrhea [HR 3.81 (95% CI: 1.89 to 7.69)], and higher log10 HIV-1 viral load [HR 2.16 (95% CI: 1.35 to 3.46)] (all P < 0.05). In multivariable analysis, age <2 years and OVC status remained significantly associated with mortality.
CONCLUSIONS
Young age and OVC status independently predicted mortality. Hypoxic pneumonia, oral thrush, and persistent diarrhea are important clinical features that predict mortality. Strategies to enhance early diagnosis in children and improve hospital management of critically ill HIV-infected children are needed.",2019,"Factors associated with mortality in univariate analysis included age <2 years [HR 3.08 (95% CI: 1.50 to 6.33)], orphaned or vulnerable child (OVC) [HR 2.05 (95% CI: 1.09 to 3.84)], weight-for-age Z score <-2","['Hospitalized HIV-Infected Children', 'HIV-infected children in Kenya', '181 enrolled children, 39 (22%) died', 'acutely ill HIV-infected children presenting with advanced HIV disease', 'We enrolled hospitalized, HIV-infected, antiretroviral therapy-naive children (0-12 years), initiated antiretroviral therapy, and followed up them for 6 months', 'Kenya']",[],"['mortality', 'persistent diarrhea', 'log10 HIV-1 viral load', 'diagnosis of pneumonia with hypoxia']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1690986', 'cui_str': 'log10'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",181.0,0.363368,"Factors associated with mortality in univariate analysis included age <2 years [HR 3.08 (95% CI: 1.50 to 6.33)], orphaned or vulnerable child (OVC) [HR 2.05 (95% CI: 1.09 to 3.84)], weight-for-age Z score <-2","[{'ForeName': 'Irene N', 'Initials': 'IN', 'LastName': 'Njuguna', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Cranmer', 'Affiliation': ""Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Anjuli D', 'Initials': 'AD', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'LaCourse', 'Affiliation': 'Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mugo', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Benki-Nugent', 'Affiliation': ''}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Stern', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maleche-Obimbo', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Dalton C', 'Initials': 'DC', 'LastName': 'Wamalwa', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002012']
882,30835887,Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial.,"The majority of women experience pain during breastfeeding initiation with few strategies to manage breast and nipple pain. In fact, women cite breast and nipple pain as among the most common reasons for breastfeeding cessation. To address this important issue, we developed a breastfeeding self-management (BSM) intervention, based on the Individual and Family Self-Management Theory Framework. In this framework, self-management is conceptualized as a process in which women use knowledge, beliefs, and social facilitation to achieve breastfeeding goals. The purpose of this longitudinal pilot randomized controlled trial was to test the feasibility, acceptability, and preliminary efficacy of the BSM intervention with women initiating breastfeeding. Recruitment of 60 women intending to breastfeed occurred within 48 hr of delivery and women were randomized to either the intervention or usual care group. The BSM intervention group received BSM education modules that included information of how to manage breast and nipple pain and self-management support through biweekly texting from the study nurse, and were asked to complete a daily breastfeeding journal. Primary outcomes measured at baseline, 1, 2, and 6 weeks will be used to (a) evaluate feasibility, acceptability, and preliminary efficacy of the BSM intervention, and (b) assess the influence of protective and risk factors of breastfeeding pain (including individual genetic polymorphisms related to pain sensitivity) on process variables for self-management of breastfeeding and breastfeeding pain, and on proximal (breastfeeding pain severity and interference, breastfeeding frequency) and distal outcomes (breastfeeding exclusivity and duration and general well-being).",2019,Recruitment of 60 women intending to breastfeed occurred within 48 hr of delivery and women were randomized to either the intervention or usual care group.,"['breast and nipple pain in breastfeeding women', '60 women intending to breastfeed occurred within 48\u2009hr of delivery and women', 'women initiating breastfeeding']","['BSM intervention', 'breastfeeding self-management (BSM) intervention', 'intervention or usual care group', 'BSM education modules']","['feasibility, acceptability, and preliminary efficacy of the BSM intervention, and (b) assess the influence of protective and risk factors of breastfeeding pain (including individual genetic polymorphisms related to pain sensitivity) on process variables for self-management of breastfeeding and breastfeeding pain, and on proximal (breastfeeding pain severity and interference, breastfeeding frequency) and distal outcomes (breastfeeding exclusivity and duration and general well-being']","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0423637', 'cui_str': 'Sore nipple (finding)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing (observable entity)'}]",60.0,0.0585871,Recruitment of 60 women intending to breastfeed occurred within 48 hr of delivery and women were randomized to either the intervention or usual care group.,"[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lucas', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bernier', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Perry', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Evans', 'Affiliation': 'Family Birthing Center, Manchester Memorial Hospital, Manchester, Connecticut.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Ramesh', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Young', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Walsh', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Starkweather', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, Connecticut.'}]",Research in nursing & health,['10.1002/nur.21938']
883,30608961,Longitudinal stability in cigarette smokers of urinary biomarkers of exposure to the toxicants acrylonitrile and acrolein.,"The urinary metabolites cyanoethyl mercapturic acid (CEMA) and 3-hydroxypropyl mercapturic acid (3-HPMA) have been widely used as biomarkers of exposure to acrylonitrile and acrolein, respectively, but there are no published data on their consistency over time in the urine of cigarette smokers. We provided, free of charge over a 20 week period, Spectrum NRC600/601 research cigarettes to cigarette smokers in the control arm of a randomized clinical trial of the reduced nicotine cigarette. Urine samples were collected at weeks 4, 8, 12, 16, and 20 and analyzed for CEMA and 3-HPMA, and total nicotine equivalents (TNE) using validated methods. Creatinine-corrected intra-class correlation coefficients for CEMA, 3-HPMA, and TNE were 0.67, 0.46, and 0.68, respectively, indicating good longitudinal consistency for CEMA, while that of 3-HPMA was fair. A strong correlation between CEMA and TNE values was observed. These data support the use of CEMA as a reliable biomarker of tobacco smoke exposure. This is the first report of the longitudinal stability of the biomarkers of acrylonitrile and acrolein exposure in smokers. The data indicate that CEMA, the biomarker of acrylonitrile exposure, is consistent over time in cigarette smokers, supporting its use. While 3-HPMA levels were less stable over time, this biomarker is nevertheless a useful monitor of human acrolein exposure because of its specificity to this toxicant.",2019,"While 3-HPMA levels were less stable over time, this biomarker is nevertheless a useful monitor of human acrolein exposure because of its specificity to this toxicant.","['cigarette smokers of urinary biomarkers of exposure to the toxicants acrylonitrile and acrolein', 'smokers']","['Spectrum NRC600/601 research cigarettes', 'CEMA']","['CEMA and 3-HPMA, and total nicotine equivalents (TNE', 'Creatinine-corrected intra-class correlation coefficients for CEMA, 3-HPMA, and TNE', 'CEMA and TNE values']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0001223', 'cui_str': 'Vinyl Cyanide'}, {'cui': 'C0001204', 'cui_str': 'Acraldehyde'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0035168'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0063186', 'cui_str': 'hydroxypropyl methacrylate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0130283,"While 3-HPMA levels were less stable over time, this biomarker is nevertheless a useful monitor of human acrolein exposure because of its specificity to this toxicant.","[{'ForeName': 'Menglan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Carmella', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Chistopher', 'Initials': 'C', 'LastName': 'Sipe', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Chap T', 'Initials': 'CT', 'LastName': 'Le', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Sharon S', 'Initials': 'SS', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""al'Absi"", 'Affiliation': 'Behavioral Medicine Laboratories, University of Minnesota Medical School, Duluth, Minnesota, United States of America.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States of America.'}]",PloS one,['10.1371/journal.pone.0210104']
884,30615896,A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds.,"PURPOSE
Two strategies were compared for managing moderate hyperopia without manifest strabismus among 1- and 2-year-old children: (1) immediate prescription of glasses versus (2) observation without glasses unless reduced distance visual acuity (VA), reduced stereoacuity, or manifest strabismus.
DESIGN
Prospective randomized clinical trial.
PARTICIPANTS
A total of 130 children aged 1 to 2 years with hyperopia between +3.00 diopters (D) and +6.00 D spherical equivalent (SE) in at least 1 eye, anisometropia ≤1.50 D SE, and astigmatism ≤1.50 D based on cycloplegic refraction and no manifest strabismus.
METHODS
Participants were randomly assigned to glasses (1.00 D less than full cycloplegic hyperopia) versus observation and followed every 6 months for 3 years. Glasses were prescribed to those assigned to observation if they met prespecified deterioration criteria of distance VA or near stereoacuity below age norms, or development of manifest strabismus.
MAIN OUTCOME MEASURES
At the 3-year primary outcome examination, participants were classified as failing the randomized management regimen if distance VA or stereoacuity was below age norms or manifest strabismus was observed (each with and without correction in trial frames, confirmed by masked retest, irrespective of whether deterioration had occurred previously), or if strabismus surgery had been performed.
RESULTS
Of the 106 participants (82%) completing the 3-year primary outcome examination, failure occurred in 11 (21%) of 53 in the glasses group and 18 (34%) of 53 in the observation group (difference = -13%; 95% confidence interval [CI], -31 to 4; P = 0.14). Sixty-two percent (95% CI, 49-74) in the observation group and 34% (95% CI, 23-48) in the glasses group met deterioration criteria (requiring glasses if not wearing).
CONCLUSIONS
For 1- and 2-year-olds with uncorrected moderate hyperopia (+3.00 D to +6.00 D SE), our estimates of failure, after 3 years of 6-month follow-ups, are inconclusive and consistent with a small to moderate benefit or no benefit of immediate prescription of glasses compared with careful observation (with glasses only if deteriorated).",2019,", failure occurred in 11 (21%) of 53 in the glasses group and 18 (34%) of 53 in the observation group (difference = -13%; 95% confidence interval [CI], -31 to 4; P = 0.14).","['moderate hyperopia without manifest strabismus among 1- and 2-year-old children', 'A total of 130 children aged 1 to 2 years with hyperopia between\xa0+3.00 diopters (D) and\xa0+6.00 D spherical equivalent (SE) in at least 1 eye, anisometropia ≤1.50 D SE, and astigmatism ≤1.50 D based on cycloplegic refraction and no manifest strabismus', 'Of the 106 participants (82%) completing the 3-year primary outcome examination', 'Participants', 'Moderate Hyperopia in 1- and 2-Year-Olds']",[],"['distance visual acuity (VA), reduced stereoacuity, or manifest strabismus']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0020490', 'cui_str': 'Hypermetropia'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}, {'cui': 'C0038379', 'cui_str': 'Phorias'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0855713', 'cui_str': 'Wet refraction'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]",[],"[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}, {'cui': 'C0038379', 'cui_str': 'Phorias'}]",130.0,0.460152,", failure occurred in 11 (21%) of 53 in the glasses group and 18 (34%) of 53 in the observation group (difference = -13%; 95% confidence interval [CI], -31 to 4; P = 0.14).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Marjean T', 'Initials': 'MT', 'LastName': 'Kulp', 'Affiliation': 'College of Optometry, The Ohio State University, Columbus, Ohio. Electronic address: pedig@jaeb.org.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Trevano W', 'Initials': 'TW', 'LastName': 'Dean', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Donny W', 'Initials': 'DW', 'LastName': 'Suh', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Kraker', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wallace', 'Affiliation': 'Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Petersen', 'Affiliation': 'Rocky Mountain Eye Care Associates, Salt Lake City, Utah.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry at Marshall B. Ketchum University, Fullerton, California.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Manny', 'Affiliation': 'University of Houston College of Optometry, Houston, Texas.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Superstein', 'Affiliation': 'Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Tawna L', 'Initials': 'TL', 'LastName': 'Roberts', 'Affiliation': 'Byers Eye Institute, Stanford University, Palo Alto, CA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Avallone', 'Affiliation': 'Ophthalmology Associates of Greater Annapolis, Arnold, Maryland.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Fishman', 'Affiliation': 'Pediatric Eye Associates, Wilmette, Illinois.'}, {'ForeName': 'S Ayse', 'Initials': 'SA', 'LastName': 'Erzurum', 'Affiliation': 'Eye Care Associates, Inc., Poland, Ohio.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Leske', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Christoff', 'Affiliation': 'Wilmer Eye Institute, Baltimore, Maryland.'}]",Ophthalmology,['10.1016/j.ophtha.2018.12.049']
885,30703190,Effect of Adding Docetaxel to Androgen-Deprivation Therapy in Patients With High-Risk Prostate Cancer With Rising Prostate-Specific Antigen Levels After Primary Local Therapy: A Randomized Clinical Trial.,"Importance
Androgen-deprivation therapy (ADT) plus docetaxel is the standard of care in hormone-naive metastatic prostate cancer but is of uncertain benefit in a nonmetastatic, high-risk prostate cancer setting.
Objective
To assess the benefit of ADT plus docetaxel in patients presenting with rising prostate-specific antigen (PSA) levels after primary local therapy and high-risk factors but no evidence of metastatic disease.
Design, Setting, and Participants
This open-label, phase 3, randomized superiority trial comparing ADT plus docetaxel vs ADT alone enrolled patients from 28 centers in France between June 4, 2003, and September 25, 2007; final follow-up was conducted April 12, 2017, and analysis was performed May 2 to July 31, 2017. Patients had undergone primary local therapy for prostate cancer, were experiencing rising PSA levels, and were considered to be at high risk of metastatic disease. Stratification was by prior local therapy and PSA-level doubling time (≤6 vs >6 months), and intention-to-treat analysis was used.
Interventions
Patients were randomly assigned to receive ADT (1 year) plus docetaxel, 70 mg/m2 (every 3 weeks [6 cycles]), or ADT alone (1 year).
Main Outcomes and Measures
The primary outcome was PSA progression-free survival (PSA-PFS). Secondary end points were PSA response, radiologic PFS, overall survival, safety, and quality of life.
Results
Overall, 254 patients were randomized (1:1) to the trial; median age, 64 years in the ADT plus docetaxel arm, 66 years in the ADT alone arm. At a median follow-up of 30.0 months, the median PSA-PFS was 20.3 (95% CI, 19.0-21.6) months in the ADT plus docetaxel arm vs 19.3 (95% CI, 18.2-20.8) months in the ADT alone arm (hazard ratio [HR], 0.85; 95% CI, 0.62-1.16; P = .31). At a median follow-up of 10.5 years, there was no significant between-arm difference in radiologic PFS (HR, 1.03; 95% CI, 0.74-1.43; P = .88). Overall survival data were not mature. The most common grade 3 or 4 hematologic toxic effects in the ADT plus docetaxel arm were neutropenia (60 of 125 patients [48.0%]), febrile neutropenia (10 [8.0%]), and thrombocytopenia (4 [3.0%]). There was no significant between-arm difference in overall quality of life.
Conclusions and Relevance
Compared with ADT alone, combined ADT plus docetaxel therapy with curative intent did not significantly improve PSA-PFS in patients with high-risk prostate cancer and rising PSA levels and no evidence of metastatic disease.
Trial Registration
French Health Products Safety Agency identifier: 030591; ClinicalTrials.gov identifier: NCT00764166.",2019,"There was no significant between-arm difference in overall quality of life.
","['enrolled patients from 28 centers in France between June 4, 2003, and September 25, 2007; final follow-up was conducted April 12, 2017, and analysis was performed May 2 to July 31, 2017', 'Patients had undergone primary local therapy for prostate cancer', 'hormone-naive metastatic prostate cancer', '254 patients were randomized (1:1) to the trial; median age, 64 years in the ADT plus docetaxel arm, 66 years in the ADT alone arm', 'patients with high-risk prostate cancer', 'Patients With High-Risk Prostate Cancer With Rising Prostate-Specific Antigen Levels', 'patients presenting with rising prostate-specific antigen (PSA) levels after primary local therapy and high-risk factors but no evidence of metastatic disease']","['Androgen-deprivation therapy (ADT) plus docetaxel', 'ADT plus docetaxel', 'ADT plus docetaxel vs ADT alone', 'ADT alone, combined ADT plus docetaxel', 'ADT alone (1 year', 'docetaxel', 'Docetaxel to Androgen-Deprivation Therapy', 'ADT']","['radiologic PFS', 'febrile neutropenia', 'median PSA-PFS', 'PSA response, radiologic PFS, overall survival, safety, and quality of life', 'thrombocytopenia', 'PSA progression-free survival (PSA-PFS', 'neutropenia', 'overall quality of life', 'Overall survival data', 'PSA-PFS', 'hematologic toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",254.0,0.224427,"There was no significant between-arm difference in overall quality of life.
","[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Latorzeff', 'Affiliation': 'Department of Oncology Radiotherapy, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Caty', 'Affiliation': 'Department of Medical Oncology, Centre Galilée, Hôpital Privé la Louvière, Lille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Miglianico', 'Affiliation': 'Department of Oncology Radiotherapy, Centre Hospitalier Privé St Grégoire, Rennes, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Sevin', 'Affiliation': 'Department of Medical Oncology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Anne Claire', 'Initials': 'AC', 'LastName': 'Hardy-Bessard', 'Affiliation': ""Department of Medical Oncology, Hôpital Privé des Côtes d'Armor, Plérin, France.""}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Delva', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Angers, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest, St Herblain, France.""}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Mouret', 'Affiliation': 'Department of Medical Oncology, Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Priou', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier de Vendée, La Roche sur Yon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Beuzeboc', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Gwenaelle', 'Initials': 'G', 'LastName': 'Gravis', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Linassier', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Bretonneau, Tours, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gomez', 'Affiliation': 'Department of Oncology Radiotherapy, Centre Joliot Curie, Rouen, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Voog', 'Affiliation': 'Department of Medical Oncology, Clinique Victor Hugo, Institut Inter-régional de Cancérologie, Le Mans, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Muracciole', 'Affiliation': 'Department of Oncology Radiotherapy, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Versailles André Mignot, Le Chesnay, France.'}, {'ForeName': 'Eugeniu', 'Initials': 'E', 'LastName': 'Banu', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Ion Chiricuta, Cluj-Napoca, Romania.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': 'Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology, Hôpital St Andre, Bordeaux, France.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Krakowski', 'Affiliation': 'Department of Medical Oncology, Centre Alexis Vautrin, Vandoeuvre Les Nancy, France.'}, {'ForeName': 'Jean-Léon', 'Initials': 'JL', 'LastName': 'Lagrange', 'Affiliation': 'Department of Medical Oncology, Hôpital Henri Mondor, Creteil, France.'}, {'ForeName': 'Gaël', 'Initials': 'G', 'LastName': 'Deplanque', 'Affiliation': 'Department of Medical Oncology, Fondation Hopital St Joseph, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zylberait', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier de Compiegne, Compiegne, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Bozec', 'Affiliation': 'Department of Medical Oncology, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Houede', 'Affiliation': 'Department of Medical Oncology, Institut Bergonie, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Culine', 'Affiliation': 'Department of Medical Oncology, Hôpital St Louis, Paris, France.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Elaidi', 'Affiliation': 'Association pour la Recherche sur les Thérapeutiques Innovantes en Cancérologie, Paris, France.'}]",JAMA oncology,['10.1001/jamaoncol.2018.6607']
886,30425180,aCGH Analysis of Predictive Biomarkers for Response to Bevacizumab plus Oxaliplatin- or Irinotecan-Based Chemotherapy in Patients with Metastatic Colorectal Cancer.,"BACKGROUND
The randomized phase III study (WJOG4407G) showed equivalent efficacy between FOLFOX and FOLFIRI in combination with bevacizumab as the first-line treatment for metastatic colorectal cancer (mCRC). We studied whole genome copy number profiles using array-based comparative genomic hybridization (aCGH) analysis of tumor tissue samples obtained in this study. The aim of this study was to identify gene copy number alterations that could aid in selecting either FOLFOX or FOLFIRI in combination with bevacizumab for patients with mCRC.
MATERIALS AND METHODS
DNA was purified from 154 pretreatment formalin-fixed paraffin-embedded tissue samples (75 from the FOLFOX arm and 79 from the FOLFIRI arm) of 395 patients enrolled in the WJOG4407G trial and analyzed by aCGH. Genomic regions greater than 1.2-fold were regarded as copy number gain (CNG).
RESULTS
Patient characteristics between the treatment arms were well balanced except for tumor laterality (left side; 64% in FOLFOX arm and 80% in FOLFIRI arm, p = .07). FOLFIRI showed a trend toward better response rate (RR), progression-free survival (PFS) and overall survival (OS) than FOLFOX in the patients with CNG of chromosome 8q24.1 (Fisher's exact test, p = .134 for RR; interaction test, p = .102 for PFS and p = .003 for OS) and 8q24.2 (Fisher's exact test, p = .179 for RR; interaction test, p = .144 for PFS and p = .002 for OS).
CONCLUSION
Chromosome 8q24.1-q24.2 may contain genes that could potentially serve as predictive markers for selecting either FOLFOX or FOLFIRI in combination with bevacizumab for treatment of patients with mCRC.
IMPLICATIONS FOR PRACTICE
Bevacizumab has been used as a standard first-line treatment for patients with metastatic colorectal cancer (mCRC) in combination with either oxaliplatin-based or irinotecan-based chemotherapy. Until now, there has been no predictive marker to choose between the two combination chemotherapies. This array-based comparative genomic hybridization analysis revealed that the difference in therapeutic effect between the two combination chemotherapies is prominent in patients with mCRC with gene copy number gain in chromosome 8p24.1-p24.2. Such patients showed more favorable response and survival when treated with irinotecan-based combination chemotherapy. Overlapping genes commonly found in this region may be predictive biomarkers of the efficacy of the combination chemotherapy with bevacizumab.",2019,"FOLFIRI showed a trend toward better response rate (RR), progression-free survival (PFS) and overall survival (OS) than FOLFOX in the patients with CNG of chromosome 8q24.1 (Fisher's exact test, p = .134 for RR; interaction test, p = .102 for PFS and p = .003 for OS) and 8q24.2 (Fisher's exact test, p = .179 for RR; interaction test, p = .144 for PFS and p = .002 for OS).
","['DNA was purified from 154 pretreatment formalin-fixed paraffin-embedded tissue samples (75 from the FOLFOX arm and 79 from the FOLFIRI arm) of 395 patients enrolled in the WJOG4407G trial and analyzed by aCGH', 'Patients with Metastatic Colorectal Cancer', 'patients with mCRC with gene copy number gain in chromosome 8p24.1-p24.2', 'metastatic colorectal cancer (mCRC', 'patients with metastatic colorectal cancer (mCRC) in combination with either', 'patients with mCRC']","['FOLFOX and FOLFIRI', 'bevacizumab', 'FOLFOX or FOLFIRI in combination with bevacizumab', 'irinotecan-based combination chemotherapy', 'Bevacizumab', 'oxaliplatin-based or irinotecan-based chemotherapy', 'Bevacizumab plus Oxaliplatin- or Irinotecan-Based Chemotherapy']","['favorable response and survival', 'copy number gain (CNG', 'tumor laterality', 'response rate (RR), progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0085185', 'cui_str': 'Paraffin Embedding'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0178655', 'cui_str': 'Gene Copy Number'}, {'cui': 'C0008633', 'cui_str': 'Chromosomes'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332304', 'cui_str': 'Laterality (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",395.0,0.0483479,"FOLFIRI showed a trend toward better response rate (RR), progression-free survival (PFS) and overall survival (OS) than FOLFOX in the patients with CNG of chromosome 8q24.1 (Fisher's exact test, p = .134 for RR; interaction test, p = .102 for PFS and p = .003 for OS) and 8q24.2 (Fisher's exact test, p = .179 for RR; interaction test, p = .144 for PFS and p = .002 for OS).
","[{'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Genome Biology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Taguri', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Sakai', 'Affiliation': 'Department of Genome Biology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsushima', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Michitaka', 'Initials': 'M', 'LastName': 'Nagase', 'Affiliation': 'Department of Clinical Oncology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tamagawa', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Nara Hospital Kindai University Faculty of Medicine, Ikoma, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Tonan Hospital, Sapporo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': 'Department of Surgery, Suita Municipal Hospital, Suita, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Taira', 'Affiliation': 'Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Sadao', 'Initials': 'S', 'LastName': 'Funai', 'Affiliation': 'Department of Surgery, Sakai Hospital Kindai University Faculty of Medicine, Sakai, Japan.'}, {'ForeName': 'Takako Eguchi', 'Initials': 'TE', 'LastName': 'Nakajima', 'Affiliation': 'Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Kochi Health Sciences Center, Kochi, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Division of Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Suyama', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kurimoto', 'Affiliation': 'Department of Gastrointestinal Oncology, Nagoya Kyoritsu Hospital, Nagoya, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.'}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Baba', 'Affiliation': 'Department of Comprehensive Clinical Oncology, Kyushu University Faculty of Medical Sciences, Fukuoka, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Seki', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Ryugasaki Saiseikai Hospital, Ryugasaki, Japan.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Shimura', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Nishio', 'Affiliation': 'Department of Genome Biology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan knishio@med.kindai.ac.jp.'}]",The oncologist,['10.1634/theoncologist.2018-0119']
887,31980214,Comparison between a nurse-led weaning protocol and a weaning protocol based on physician's clinical judgment in ICU patients.,"PURPOSE
The purpose of this study was to compare a nurse-led weaning protocol with a physician-driven weaning protocol in mechanically ventilated (MV) patients.
METHODS
In this quasi-experimental study with a one-group design, a total of 65 ICU patients, requiring MV for more than 72 h, were selected via convenience sampling. In routine practice, the physician's clinical judgment is needed to determine the patient's readiness for liberation from MV. A physician-driven weaning protocol was compared with a nurse-led protocol, using Burn's Weaning Scale (BWS) in three working phases. Descriptive and inferential statistics were measured for data analysis using SPSS version 16.
RESULTS
Based on BWS, the mean MV duration was 111.75±33.46 h in the nurse-led weaning group and 125.12±43.43 h in the physician-driven weaning group. There was a significant difference in terms of MV duration between the two groups (P = 0.000).
CONCLUSION
The present findings showed that nurses' assessment of patient's readiness for weaning from MV (BWS) is a safe approach during the day, which can reduce MV duration more than other typical methods in ICUs.",2020,h in the nurse-led weaning group and 125.12±43.43 h in the physician-driven weaning group.,"['65 ICU patients, requiring MV for more than 72\xa0h, were selected via convenience sampling', 'ICU patients', 'mechanically ventilated (MV) patients']",['nurse-led weaning protocol with a physician-driven weaning protocol'],"['MV duration', 'mean MV duration']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",65.0,0.0500678,h in the nurse-led weaning group and 125.12±43.43 h in the physician-driven weaning group.,"[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Ghanbari', 'Affiliation': 'Social Determinants of Health Research Center, School of Nursing and Midwifery, Guilan University of Medical Science, Rasht, Iran. Electronic address: at_ghanbari@gums.ac.ir.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Mohammad Ebrahimzadeh', 'Affiliation': 'The Heart Hospital of Doctor Heshmat, Guilan University of Medical Science, Rasht, Iran. Electronic address: Aidame64@gmail.com.'}, {'ForeName': 'Ezzat', 'Initials': 'E', 'LastName': 'Paryad', 'Affiliation': 'Social Determinants of Health Research Center(SDHRC), School of Nursing and Midwifery, Guilan University of Medical Science, Rasht, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Atrkar Roshan', 'Affiliation': 'Bio-Statistics, School of Medicine, Guilan University of Medical Science, Rasht, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kazem Mohammadi', 'Affiliation': 'Guilan Province the Social Security Organization, Rasoul Akram Hospital, Rasht, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Mokhtari Lakeh', 'Affiliation': 'School of Nursing and Midwifery, Guilan University of Medical Science, Rasht, Iran.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.01.003']
888,31947735,The Effects of the PLAYTOD Program on Children's Physical Activity at Preschool Playgrounds in a Deprived Urban Area: A Randomized Controlled Trial.,"Interventions to improve children's physical activity in Early Childhood Education and Care (ECEC) settings are needed. This randomized controlled trial examines the effects of a preschool-based playground program for ECEC teachers in a deprived urban area. On intervention preschools, the PLAYgrounds for TODdlers program (PLAYTOD) was performed. It focused on teacher's knowledge and skills in order to create a challenging outdoor environment in which young children (2.5 to 4 years old) are able to practice their motor skills. Observations were performed before and after the program with a modified version of the SOPLAY protocol. The activating role of teachers (score from 0 = inactive to 4 = participating), the number of different physical activities, and the quality of children's physical activity on playgrounds were observed. The latter included the number of performed fundamental movement skills and the estimated physical activity intensity (score from 0 = sedentary to 3 = vigorous). Descriptive statistics and linear regression analyses were used to evaluate the effects of PLAYTOD. After the program, the activating role of teachers on intervention playgrounds improved. Moreover, the program and consecutively the changes made by teachers had a positive effect on the number of different activities and the quality of children's physical activity. The results emphasize an important role for ECEC teachers in improving physical activity in young children.",2020,"Moreover, the program and consecutively the changes made by teachers had a positive effect on the number of different activities and the quality of children's physical activity.","['ECEC teachers in a deprived urban area', 'young children (2.5 to 4 years old', 'young children', ""Children's Physical Activity at Preschool Playgrounds in a Deprived Urban Area""]",['preschool-based playground program'],"['physical activity intensity', ""number of different activities and the quality of children's physical activity"", 'physical activity']","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442596', 'cui_str': 'School playground (environment)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442596', 'cui_str': 'School playground (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.0169922,"Moreover, the program and consecutively the changes made by teachers had a positive effect on the number of different activities and the quality of children's physical activity.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Toussaint', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Dokter Meurerlaan 8, 1067 SM Amsterdam, The Netherlands.'}, {'ForeName': 'Martinette T', 'Initials': 'MT', 'LastName': 'Streppel', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Dokter Meurerlaan 8, 1067 SM Amsterdam, The Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Mul', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Dokter Meurerlaan 8, 1067 SM Amsterdam, The Netherlands.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Fukkink', 'Affiliation': 'Faculty of Child Development and Education, Amsterdam University of Applied Sciences, Wibautstraat 2-4, 1091 GM Amsterdam, The Netherlands.'}, {'ForeName': 'Peter J M', 'Initials': 'PJM', 'LastName': 'Weijs', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Dokter Meurerlaan 8, 1067 SM Amsterdam, The Netherlands.'}, {'ForeName': 'Mirka', 'Initials': 'M', 'LastName': 'Janssen', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Dokter Meurerlaan 8, 1067 SM Amsterdam, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17010329']
889,29920980,"Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Bapineuzumab: A Single-Ascending-Dose Study in Patients With Mild to Moderate Alzheimer Disease.","This study was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending subcutaneous doses of bapineuzumab in patients with mild to moderate Alzheimer disease. Forty patients were randomized across 5 cohorts (5 mg, 10 mg, 20 mg, 40 mg, 80 mg; 8 patients each [bapineuzumab 6; placebo 2]). The incidence of treatment-emergent adverse events (TEAEs) was higher in pooled bapineuzumab cohorts (83%) than in the pooled placebo group (27.7%). Most common TEAEs in the bapineuzumab group were gastrointestinal disorders and musculoskeletal and connective tissue disorders (bapineuzumab 17% each; placebo 0%). Serious TEAEs were observed in 7% of bapineuzumab-treated patients without any deaths or adverse event-related discontinuation. The median times to reach peak measurable concentration (C max ) of bapineuzumab were 14 days for 5-, 10-, and 20-mg cohorts, 11 days for 40-mg, and 7 days for 80-mg cohorts. The apparent volume of distribution of bapineuzumab was 134.29 to 204.68 mL/kg. The total body clearance was consistent at 10 to 80 mg. The average terminal half-life ranged from 26 to 46 days (5- to 80-mg groups). Exposure to bapineuzumab increased dose-proportionally from 10 to 80 mg. There was a positive correlation between C max and area under the concentration-time curve to the last measurable concentration (AUC last ) of plasma amyloid-β, and between the C max and AUC last of serum bapineuzumab.",2019,Serious TEAEs were observed in 7% of bapineuzumab-treated patients without any deaths or adverse event-related discontinuation.,"['patients with mild to moderate Alzheimer disease', 'Forty patients', 'Patients']","['Subcutaneous Bapineuzumab', 'bapineuzumab', 'bapineuzumab 6; placebo']","['median times to reach peak measurable concentration (C max ) of bapineuzumab', 'apparent volume of distribution of bapineuzumab', 'incidence of treatment-emergent adverse events (TEAEs', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'total body clearance', 'C max and area under the concentration-time curve', 'Pharmacokinetics, Pharmacodynamics, and Safety', 'gastrointestinal disorders and musculoskeletal and connective tissue disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C2698328', 'cui_str': 'bapineuzumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2698328', 'cui_str': 'bapineuzumab'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0263660', 'cui_str': 'Musculoskeletal and connective tissue disorder (disorder)'}]",40.0,0.0800573,Serious TEAEs were observed in 7% of bapineuzumab-treated patients without any deaths or adverse event-related discontinuation.,"[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': ""Janssen Alzheimer's Immunotherapy Research & Development, Spring House, PA, USA.""}, {'ForeName': 'H Robert', 'Initials': 'HR', 'LastName': 'Brashear', 'Affiliation': ""Janssen Alzheimer's Immunotherapy Research & Development, Spring House, PA, USA.""}]",Clinical pharmacology in drug development,['10.1002/cpdd.584']
890,29947474,"Comparative Bioavailability of Sildenafil 50-mg Film-Coated Tablets and 50-mg Orally Disintegrating Films in Healthy Mexican Subjects: Results From a Randomized, Open-Label, Crossover Study.","An orally disintegrating film formulation of sildenafil 50 mg (CL Pharm Co, Ltd) was used in this study and compared to the market-available product film coated tablets (Viagra ® , Pfizer, Mexico). The objective was to compare the pharmacokinetic properties of these products after a single-dose administration to 47 healthy male volunteers (aged 19-48 years) in a randomized, open-label, 2-way crossover study. Each subject received a single oral dose of 50 mg of sildenafil test or reference product administered under fasting conditions at each of the 2 study periods according to a crossover design. There was a 3-day washout period between drug administrations. Blood samples for pharmacokinetic analysis were collected predose and at different times postdosing. The maximum plasma concentration and area under the curve from administration to last observed concentration time of test and reference products were compared. Pharmacokinetic parameters shown to be within the confidence interval 80% to 125% for log-transformed data and Shuirmann and Anderson Hauck tests showed a high probability that area under the curve values for the test product were within 80% to 125% (P < .05). Adverse events occurred at similar rates for the 2 formulations (8 for each product), headache being the most prevalent. The results suggest that the 2 sildenafil formulations, orally disintegrating films and film-coated tablets, are similar in terms of bioavailability, making the test product a good alternative to treat erectile dysfunction and improving dosing convenience.",2019,"Adverse events occurred at similar rates for the 2 formulations (8 for each product), headache being the most prevalent.","['Healthy Mexican Subjects', '47 healthy male volunteers (aged 19-48 years']","['sildenafil 50 mg (CL Pharm Co, Ltd', 'sildenafil', 'Sildenafil 50-mg Film-Coated Tablets and 50-mg Orally Disintegrating Films']","['Adverse events', 'maximum plasma concentration and area under the curve', 'headache']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0989894', 'cui_str': 'sildenafil 50 MG'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}, {'cui': 'C4319646', 'cui_str': 'Film'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",47.0,0.0790534,"Adverse events occurred at similar rates for the 2 formulations (8 for each product), headache being the most prevalent.","[{'ForeName': 'Luis García', 'Initials': 'LG', 'LastName': 'Aguirre', 'Affiliation': 'Investigación Farmacológica y Biofarmacéutica (IFaB), Tlalpan, México, DF, Mexico.'}, {'ForeName': 'Isabel Ruiz', 'Initials': 'IR', 'LastName': 'Olmedo', 'Affiliation': 'Investigación Farmacológica y Biofarmacéutica (IFaB), Tlalpan, México, DF, Mexico.'}, {'ForeName': 'Araceli Medina', 'Initials': 'AM', 'LastName': 'Nolasco', 'Affiliation': 'Investigación Farmacológica y Biofarmacéutica (IFaB), Tlalpan, México, DF, Mexico.'}, {'ForeName': 'Yamanqui Ibáñez', 'Initials': 'YI', 'LastName': 'Romo', 'Affiliation': 'Investigación Farmacológica y Biofarmacéutica (IFaB), Tlalpan, México, DF, Mexico.'}, {'ForeName': 'Liz Medina', 'Initials': 'LM', 'LastName': 'Reyes', 'Affiliation': 'Investigación Farmacológica y Biofarmacéutica (IFaB), Tlalpan, México, DF, Mexico.'}, {'ForeName': 'Dolores Adriana Aguilera', 'Initials': 'DAA', 'LastName': 'Hernández', 'Affiliation': 'Comercializadora y Distribuidora en General Jazih, Mexico City, SA de CV, Mexico.'}, {'ForeName': 'Ana Laura Rojas', 'Initials': 'ALR', 'LastName': 'Vargas', 'Affiliation': 'Comercializadora y Distribuidora en General Jazih, Mexico City, SA de CV, Mexico.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.599']
891,29966038,Evaluation of Food and Spherical Carbon Adsorbent Effects on the Pharmacokinetics of Roxadustat in Healthy Nonelderly Adult Male Japanese Subjects.,"Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor in late-stage clinical development for the treatment of anemia in chronic kidney disease. Spherical carbon adsorbent (SCA) is used in patients with chronic kidney disease and has been shown to impact absorption of certain concomitant drugs. Two phase 1, open-label, randomized, crossover studies were conducted in healthy adult Japanese males to investigate the effect of food and SCA on the pharmacokinetics of a single oral dose of roxadustat. Subjects in the food effect study received a single dose of 100-mg roxadustat under fed and fasted conditions. Subjects in the SCA/roxadustat drug-drug interaction study received a single dose of 100-mg roxadustat alone, concomitantly with SCA, and 1 and 2 hours before and after SCA to consider the real-world clinical situation and assess any potential impact of a lag time on the pharmacokinetics of roxadustat. Primary outcomes for both studies were area under the concentration-time curve from the time of dosing extrapolated to infinity and maximum concentration of drug in blood plasma. In the food effect study (N = 16), the geometric mean ratio (fed/fasted) and 90% confidence interval for area under the concentration-time curve from the time of dosing extrapolated to infinity and maximum concentration of roxadustat were 94.44 (89.93-99.18) and 79.88 (72.09-88.52), respectively. In the SCA/roxadustat drug-drug interaction study, all geometric mean ratios and 90% confidence intervals (roxadustat + SCA/roxadustat) were within the no-effect boundaries of 80% and 125%. Roxadustat was generally well tolerated. The effect of food on the pharmacokinetics of roxadustat and the drug-drug interaction between roxadustat and SCA do not appear to be clinically relevant and support the safe use of roxadustat under these conditions.",2019,Roxadustat was generally well tolerated.,"['healthy adult Japanese males', 'Healthy Nonelderly Adult Male Japanese Subjects', 'patients with chronic kidney disease']","['Food and Spherical Carbon Adsorbent', 'Spherical carbon adsorbent (SCA', '100-mg roxadustat under fed and fasted conditions']","['tolerated', 'geometric mean ratio', 'area under the concentration-time curve from the time of dosing extrapolated to infinity and maximum concentration of drug in blood plasma']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0350056', 'cui_str': 'Adsorbents (product)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4310578'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.0446001,Roxadustat was generally well tolerated.,"[{'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Shibata', 'Affiliation': 'Clinical Pharmacology, Development, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Research Program Management, Drug Discovery Research, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Akitsugu', 'Initials': 'A', 'LastName': 'Takada', 'Affiliation': 'Clinical Pharmacology, Development, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Japan-Asia Data Science, Development, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Katashima', 'Affiliation': 'Clinical Pharmacology, Development, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Yazawa', 'Affiliation': 'Medical Co. LTA Sumida Hospital, Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Furihata', 'Affiliation': 'Director, P-One Clinic, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.597']
892,30529244,Concurrent treatment of substance use disorders and PTSD using prolonged exposure: A randomized clinical trial in military veterans.,"OBJECTIVE
A substantial amount of individuals with substance use disorders (SUD) also meet criteria for posttraumatic stress disorder (PTSD). Prolonged Exposure (PE) is an effective, evidence-based treatment for PTSD, but there is limited data on its use among individuals with current alcohol or drug use disorders. This study evaluated the efficacy of an integrated treatment that incorporates PE (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure or COPE) among veterans.
METHOD
Military veterans (N = 81, 90.1% male) with current SUD and PTSD were randomized to 12 sessions of COPE or Relapse Prevention (RP). Primary outcomes included the Clinician Administered PTSD Scale (CAPS), PTSD Checklist-Military version (PCL-M), and the Timeline Follow-back (TLFB).
RESULTS
On average, participants attended 8 out of 12 sessions and there were no group differences in retention. Intent-to-treat analyses revealed that COPE, in comparison to RP, resulted in significantly greater reductions in CAPS (d = 1.4, p < .001) and PCL-M scores (d = 1.3, p = .01), as well as higher rates of PTSD diagnostic remission (OR = 5.3, p < .01). Both groups evidenced significant and comparable reductions in SUD severity during treatment. At 6-months follow-up, participants in COPE evidenced significantly fewer drinks per drinking day than participants in RP (p = .05).
CONCLUSIONS
This study is the first to report on the use of an integrated, exposure-based treatment for co-occurring SUD and PTSD in a veteran sample. The findings demonstrate that integrated, exposure-based treatments are feasible and effective for military veterans with SUD and PTSD. Implications for clinical practice are discussed.",2019,"On average, participants attended 8 out of 12 sessions and there were no group differences in retention.","['individuals with substance use disorders (SUD) also meet criteria for posttraumatic stress disorder (PTSD', 'military veterans', 'Military veterans (N\u202f=\u202f81, 90.1% male) with current SUD and PTSD', 'military veterans with SUD and PTSD', 'individuals with current alcohol or drug use disorders', 'veterans', 'PTSD and Substance Use Disorders']","['Prolonged Exposure (PE', 'Prolonged Exposure or COPE', 'COPE or Relapse Prevention (RP']","['CAPS', 'retention', 'PTSD diagnostic remission', 'Clinician Administered PTSD Scale (CAPS), PTSD Checklist-Military version (PCL-M), and the Timeline Follow-back (TLFB', 'SUD severity', 'PCL-M scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013222', 'cui_str': 'Drug Use Disorders'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}]","[{'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0116944,"On average, participants attended 8 out of 12 sessions and there were no group differences in retention.","[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Christal L', 'Initials': 'CL', 'LastName': 'Badour', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Allan', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, USA.'}, {'ForeName': 'Elizabeth Santa', 'Initials': 'ES', 'LastName': 'Ana', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lozano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Kristina J', 'Initials': 'KJ', 'LastName': 'Korte', 'Affiliation': 'Psychiatry Department, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.11.032']
893,29786959,"Assessment of the Drug Interaction Potential of Ertugliflozin With Sitagliptin, Metformin, Glimepiride, or Simvastatin in Healthy Subjects.","Ertugliflozin, a sodium-glucose cotransporter 2 inhibitor for the treatment of adults with type 2 diabetes mellitus, is expected to be coadministered with sitagliptin, metformin, glimepiride, and/or simvastatin. Four separate open-label, randomized, single-dose, crossover studies were conducted in healthy adults to assess the potential pharmacokinetic interactions between ertugliflozin 15 mg and sitagliptin 100 mg (n = 12), metformin 1000 mg (n = 18), glimepiride 1 mg (n = 18), or simvastatin 40 mg (n = 18). Noncompartmental pharmacokinetic parameters derived from plasma concentration-time data were analyzed using mixed-effects models to assess interactions. Coadministration of sitagliptin, metformin, glimepiride, or simvastatin with ertugliflozin had no effect on area under the plasma concentration-time profile from time 0 to infinity (AUC inf ) or maximum observed plasma concentration (C max ) of ertugliflozin (per standard bioequivalence boundaries, 80% to 125%). Similarly, ertugliflozin did not have any impact on AUC inf or C max of sitagliptin, metformin, or glimepiride. AUC inf for simvastatin (24%) and simvastatin acid (30%) increased slightly after coadministration with ertugliflozin and was not considered clinically relevant. All treatments were well tolerated. The lack of clinically meaningful pharmacokinetic interactions demonstrates that ertugliflozin can be coadministered safely with sitagliptin, metformin, glimepiride, or simvastatin without any need for dose adjustment.",2019,AUC inf for simvastatin (24%) and simvastatin acid (30%) increased slightly after coadministration with ertugliflozin and was not considered clinically relevant.,"['Healthy Subjects', 'healthy adults', 'adults with type 2 diabetes mellitus']","['simvastatin acid', 'Ertugliflozin, a sodium-glucose cotransporter 2 inhibitor', 'metformin', 'glimepiride', 'sitagliptin, metformin, glimepiride, or simvastatin', 'ertugliflozin 15 mg and sitagliptin', 'sitagliptin, metformin, glimepiride, or simvastatin with ertugliflozin', 'simvastatin', 'ertugliflozin', 'Ertugliflozin With Sitagliptin, Metformin, Glimepiride, or Simvastatin', 'sitagliptin, metformin, glimepiride, and/or simvastatin']","['AUC inf or C max of sitagliptin, metformin, or glimepiride', 'area under the plasma concentration-time profile from time 0 to infinity (AUC inf ) or maximum observed plasma concentration (C max ) of ertugliflozin', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0246012', 'cui_str': 'simvastatin acid'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C4535692', 'cui_str': 'ertugliflozin 15 MG [Steglatro]'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}]",,0.0172459,AUC inf for simvastatin (24%) and simvastatin acid (30%) increased slightly after coadministration with ertugliflozin and was not considered clinically relevant.,"[{'ForeName': 'Vikas Kumar', 'Initials': 'VK', 'LastName': 'Dawra', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Cutler', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Alvey', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Saur', 'Affiliation': 'Pfizer Inc., Paris, France.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Sahasrabudhe', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.472']
894,29790196,Rituximab Is Ineffective for Treatment of Fatigue in Primary Biliary Cholangitis: A Phase 2 Randomized Controlled Trial.,"Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease. Half of patients experience debilitating fatigue, which is currently untreatable. Previous studies have shown muscle bioenergetic abnormalities in PBC, including increased muscle acidosis with exercise linked to the antimitochondrial antibody (AMA) diagnostic of the disease, and reduced anaerobic threshold. In this study we addressed the hypothesis that fatigue in PBC is driven by muscle bioenergetic abnormality related to AMA, and that AMA reduction with B-cell depletion therapy will improve fatigue. In our single-center phase 2 randomized controlled trial, 57 participants aged 18 years or older with PBC and moderate to severe fatigue were randomized to receive two doses of either rituximab (1000 mg) or saline (placebo). The primary outcome measure was fatigue severity assessed using the PBC-40 fatigue domain at 3 months. Secondary outcome measures included patient-reported outcomes and immunological and bioenergetics disease parameters. Experimental outcomes included biochemical markers of disease severity. Improvement in fatigue score at 3 months was seen in both arms, with no significant difference (adjusted mean difference -0.9 [95% confidence interval -4.6 to 3.1]). Little difference was observed in other patient-reported outcomes or physical activity. Significant anaerobic threshold improvement was seen in the rituximab group, only but this was not associated with fatigue improvement. No treatment-emergent serious adverse events were seen. Conclusions: Rituximab was safe over the 12-month study period but showed no evidence of effectiveness for the treatment of fatigue in PBC. Anaerobic threshold improvement was seen, potentially linking AMA with muscle bioenergetics dysfunction; however, this was not related to improvement in fatigue. Rituximab had some evidence of a beneficial effect on alkaline phosphatase levels in this largely ursodeoxycholic acid (UDCA)-responding, early-disease stage cohort. (Hepatology 2018; 00:000-000).",2019,"Improvement in fatigue score at 3 months was seen in both arms, with no significant difference (adjusted mean difference -0.9","['57 participants aged 18 years or older with PBC and moderate to severe fatigue', 'Primary Biliary Cholangitis']","['ursodeoxycholic acid', 'Rituximab', 'rituximab (1000 mg) or saline (placebo']","['fatigue', 'biochemical markers of disease severity', 'fatigue improvement', 'fatigue severity assessed using the PBC-40 fatigue domain', 'patient-reported outcomes and immunological and bioenergetics disease parameters', 'Significant anaerobic threshold improvement', 'alkaline phosphatase levels', 'Primary biliary cholangitis (PBC', 'fatigue score']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}]","[{'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0428332', 'cui_str': 'Alkaline phosphatase level - finding'}, {'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",57.0,0.333394,"Improvement in fatigue score at 3 months was seen in both arms, with no significant difference (adjusted mean difference -0.9","[{'ForeName': 'Amardeep', 'Initials': 'A', 'LastName': 'Khanna', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jopson', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bryant', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blamire', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Newton', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Jones', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30099']
895,32144059,"Randomized Prospective Study Evaluating Single-Injection Paravertebral Block, Paravertebral Catheter, and Thoracic Epidural Catheter for Postoperative Regional Analgesia After Video-Assisted Thoracoscopic Surgery.","OBJECTIVE
Video-assisted thoracoscopic surgery (VATS) has improved patient outcomes; however, postoperative pain remains potentially severe. The objective of this study was to compare adjunct analgesic modalities for VATS, including paravertebral nerve blockade (PVB) and thoracic epidural anesthesia (TEA).
DESIGN
Prospective, randomized trial.
SETTING
Large academic hospital, single institution.
PARTICIPANTS
Adult patients undergoing VATS.
INTERVENTIONS
Ultrasound-guided PVB catheter, ultrasound-guided single-injection PVB, or TEA.
MEASUREMENTS AND MAIN RESULTS
Postoperative visual analog scale pain scores (at rest and with knee flexion) and opioid usage were recorded. Pain scores (with movement) for the TEA group were lower than those for either PVB group at 24 hours (p ≤ 0.008) and for the PVB catheter group at 48 hours (p = 0.002). Opioid use in TEA group was lower than that for either PVB group at 24 and 48 hours (p < 0.001) and 72 hours (p < 0.05). Single-injection PVB was faster compared with PVB catheter placement (6 min v 12 min; p < 0.001) but similar to TEA (5 min). Patient satisfaction, nausea, sedation, and 6-month postsurgical pain did not differ between groups.
CONCLUSIONS
TEA led to lower pain scores and opioid requirement for VATS procedures compared with PVB techniques. Single-injection PVB was faster and equally as effective as PVB catheter, and it led to similar patient satisfaction as TEA; therefore, it should be considered in patients who are not ideal candidates for TEA.",2020,"Single-injection PVB was faster and equally as effective as PVB catheter, and it led to similar patient satisfaction as TEA; therefore, it should be considered in patients who are not ideal candidates for TEA.","['patients who are not ideal candidates for TEA', 'Adult patients undergoing VATS', 'Large academic hospital, single institution']","['PVB catheter placement', 'Single-Injection Paravertebral Block, Paravertebral Catheter, and Thoracic Epidural Catheter for Postoperative Regional Analgesia', 'Ultrasound-guided PVB catheter, ultrasound-guided single-injection PVB, or TEA', 'PVB', 'paravertebral nerve blockade (PVB) and thoracic epidural anesthesia (TEA', 'Video-assisted thoracoscopic surgery (VATS', 'TEA', 'Video-Assisted Thoracoscopic Surgery']","['Postoperative visual analog scale pain scores (at rest and with knee flexion) and opioid usage', 'Patient satisfaction, nausea, sedation, and 6-month postsurgical pain', 'Pain scores', 'pain scores and opioid requirement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter, device (physical object)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.110296,"Single-injection PVB was faster and equally as effective as PVB catheter, and it led to similar patient satisfaction as TEA; therefore, it should be considered in patients who are not ideal candidates for TEA.","[{'ForeName': 'Yar Luan', 'Initials': 'YL', 'LastName': 'Yeap', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN. Electronic address: yyeap@iu.edu.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Wolfe', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Backfish-White', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jerry V', 'Initials': 'JV', 'LastName': 'Young', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Duykhanh P', 'Initials': 'DP', 'LastName': 'Ceppa', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Elizabeth A S', 'Initials': 'EAS', 'LastName': 'Moser', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine and Richard M. Fairbanks School of Public Health, Indianapolis, IN.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Birdas', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.01.036']
896,32072685,"Algae-derived hydroxyapatite behavior as bone biomaterial in comparison with anorganic bovine bone: A split-mouth clinical, radiological, and histologic randomized study in humans.","OBJECTIVES
To analyze a modified biphasic phycogenic biomaterial in comparison with anorganic bovine bone in maxillary sinus floor elevation in humans.
MATERIAL AND METHODS
Eight male patients in need of bilateral two-stage sinus floor elevation were consecutively recruited for this randomized split-mouth study. A combination of autogenous cortical bone (ACB, 20%) and anorganic bovine bone (ABB, 80%) (ACB + ABB group) or ACB (20%) and modified biphasic phycogenic material (BP, 80%) (ACB + BP group) were randomly assigned to graft each sinus. Patients were followed up for 6 months post-surgery when bone samples were collected for analysis.
RESULTS
Radiographically, bone height gain was statistically higher in the ACB + ABB versus the ACB + BP group. While the analysis of the biological compartments showed differences in non-mineralized tissue (39.15 ± 20.97% vs. 65.87 ± 28.59%, ACB + ABB vs. ACB + BP respectively; p = .018) and remnant biomaterial particles (22.62 ± 17.01% vs. 7.96 ± 8.57%, respectively; p = .028), the percentage of mineralized tissue (38.23 ± 17.55% vs. 24.14 ± 24.66%, respectively; p = .398) showed no statistically significant difference. In contrast, ACB + ABB biopsies showed higher Musashi-1-positive cells per mm 2 compared to ACB + BP biopsies (811.49 ± 875.30 vs. 236.90 ± 280.81; p < .018), where the fusiform cells corresponded mainly with fibroblasts, as demonstrated by ultrastructural analysis.
CONCLUSION
Both combinations of materials exhibited bone formation after 6 months of healing in the maxillary sinus cavity. However, the combination with biphasic phycogenic biomaterial induced a higher radiographical vertical resorption and graft collapse in comparison with the combination with anorganic bovine bone, possibly due to a higher remodeling of the graft.",2020,"In contrast, ACB+ABB biopsies showed higher Musashi-1 positive cells per mm 2 compared to ACB+BP biopsies (811.49±875.30 vs. 236.90±280.81; p<0.018), where the fusiform cells corresponded mainly with fibroblasts, as demonstrated by ultrastructural analysis.
","['Eight male patients in need of bilateral two-stage sinus floor elevation', 'comparison with anorganic bovine bone in maxillary sinus floor elevation in humans', 'humans']","['autogenous cortical bone (ACB, 20%) and anorganic bovine bone (ABB, 80%) (ACB+ABB group) or ACB (20%) and modified biphasic phycogenic material (BP, 80%) (ACB+BP']","['radiographical vertical resorption and graft collapse', 'bone height gain', 'percentage of mineralized tissue', 'non-mineralized tissue', 'remnant biomaterial particles', 'Musashi-1 positive cells']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone (body structure)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0005479', 'cui_str': 'Biomaterials'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",8.0,0.0959988,"In contrast, ACB+ABB biopsies showed higher Musashi-1 positive cells per mm 2 compared to ACB+BP biopsies (811.49±875.30 vs. 236.90±280.81; p<0.018), where the fusiform cells corresponded mainly with fibroblasts, as demonstrated by ultrastructural analysis.
","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Galindo-Moreno', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Padial-Molina', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Lopez-Chaichio', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Gutiérrez-Garrido', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Martín-Morales', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': ""O'Valle"", 'Affiliation': 'Department of Pathology and IBIMER, School of Medicine, University of Granada, Granada, Spain.'}]",Clinical oral implants research,['10.1111/clr.13590']
897,31518175,Niraparib Maintenance Treatment Improves Time Without Symptoms or Toxicity (TWiST) Versus Routine Surveillance in Recurrent Ovarian Cancer: A TWiST Analysis of the ENGOT-OV16/NOVA Trial.,"PURPOSE
This study estimated time without symptoms or toxicity (TWiST) with niraparib compared with routine surveillance (RS) in the maintenance treatment of patients with recurrent ovarian cancer.
PATIENTS AND METHODS
Mean progression-free survival (PFS) was estimated for niraparib and RS by fitting parametric survival distributions to Kaplan-Meier data for 553 patients with recurrent ovarian cancer who were enrolled in the phase III ENGOT-OV16/NOVA trial. Patients were categorized according to the presence or absence of a germline BRCA mutation-g BRCA mut and non-g BRCA mut cohorts. Mean time with toxicity was estimated based on the area under the Kaplan-Meier curve for symptomatic grade 2 or greater fatigue, nausea, and vomiting adverse events (AEs). Time with toxicity was the number of days a patient experienced an AE post-random assignment and before disease progression. TWiST was estimated as the difference between mean PFS and time with toxicity. Uncertainty was explored using alternative PFS estimates and considering all symptomatic grade 2 or greater AEs.
RESULTS
In the g BRCA mut and non-g BRCA mut cohorts, niraparib treatment resulted in a mean PFS benefit of 3.23 years and 1.44 years, respectively, and a mean time with toxicity of 0.28 years and 0.10 years, respectively, compared with RS. Hence, niraparib treatment resulted in a mean TWiST benefit of 2.95 years and 1.34 years, respectively, compared with RS, which is equivalent to more than four-fold and two-fold increases in mean TWiST between niraparib and RS in the g BRCA mut and non-g BRCA mut cohorts, respectively. This TWiST benefit was consistent across all sensitivity analyses, including modeling PFS over 5-, 10-, and 15-year time horizons.
CONCLUSION
Patients who were treated with niraparib compared with RS experienced increased mean TWiST. Thus, patients who were treated with niraparib in the ENGOT-OV16/NOVA trial experienced more time without symptoms or symptomatic toxicities compared with control.",2019,"In the g BRCA mut and non-g BRCA mut cohorts, niraparib treatment resulted in a mean PFS benefit of 3.23 years and 1.44 years, respectively, and a mean time with toxicity of 0.28 years and 0.10 years, respectively, compared with RS.","['Patients were categorized according to the presence or absence of a germline BRCA mutation-g BRCA mut and non-g BRCA mut cohorts', 'patients with recurrent ovarian cancer', 'Recurrent Ovarian Cancer', '553 patients with recurrent ovarian cancer who were enrolled in the phase III ENGOT-OV16/NOVA trial']","['routine surveillance (RS', 'Niraparib Maintenance', 'TWiST']","['fatigue, nausea, and vomiting adverse events (AEs', 'time without symptoms or symptomatic toxicities', 'time without symptoms or toxicity (TWiST', 'Time with toxicity', 'mean TWiST benefit', 'mean PFS benefit', 'Without Symptoms or Toxicity (TWiST', 'Mean time with toxicity', 'Mean progression-free survival (PFS', 'mean PFS and time with toxicity', 'mean TWiST', 'mean time with toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",553.0,0.0826001,"In the g BRCA mut and non-g BRCA mut cohorts, niraparib treatment resulted in a mean PFS benefit of 3.23 years and 1.44 years, respectively, and a mean time with toxicity of 0.28 years and 0.10 years, respectively, compared with RS.","[{'ForeName': 'Ursula A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Walder', 'Affiliation': 'FIECON, Ltd, St Albans, United Kingdom.'}, {'ForeName': 'Trine J', 'Initials': 'TJ', 'LastName': 'Nøttrup', 'Affiliation': 'Nordic Society of Gynaecological Oncology and Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'PMHC and University of Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Arbeitsgemeinschaft Gynäkologische Onkologie and University of Munich, Munich, Germany.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Gil-Martin', 'Affiliation': ""Grupo Español de Investigación en Cáncer de Ovario and Institut Català d'Oncologia-IDIBELL, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Kalbacher', 'Affiliation': ""Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens and University Hospital Besançon, Besançon, France.""}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'National Cancer Research Institute and University College London Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Woie', 'Affiliation': 'Nordic Society of Gynaecological Oncology and Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Lau', 'Affiliation': 'PMHC and Jewish General Hospital, Montreal, Québec, Canada.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Arbeitsgemeinschaft Gynäkologische Onkologie and Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Casado Herraez', 'Affiliation': 'Grupo Español de Investigación en Cáncer de Ovario and Hospital Universitario San Carlos, Madrid, Spain.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Hardy-Bessard', 'Affiliation': ""Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens and Centre Amoricain D'Oncologie, Paris, France.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'National Cancer Research Institute and The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lindahl', 'Affiliation': 'Nordic Society of Gynaecological Oncology and Linköping University Hospital, Linköping, Sweden.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Benigno', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Buscema', 'Affiliation': 'Arizona Oncology, Tucson, AZ.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Travers', 'Affiliation': 'TESARO: A GSK Company, Waltham, MA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Guy', 'Affiliation': 'FIECON, Ltd, St Albans, United Kingdom.'}, {'ForeName': 'Mansoor R', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology and Copenhagen University Hospital, Copenhagen, Denmark.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00917']
898,31984502,Growing Together-Effects of a school-based intervention promoting positive self-beliefs and social integration in recently immigrated children.,"We present a school-based intervention geared to foster the social integration of recently immigrated (RI) primary school children by creating repeated positive contact situations with classmates brought up in the receiving society. Coaches encouraged groups of tandems, consisting of one RI and one child brought up in Germany each, to engage in cooperative activities designed to strengthen positive self-beliefs and perception of equal status. In a quasi-experimental control-group design (N = 318), we compared the 30 children (12 RI) who participated in our intervention between pre-test and post-test with a reference group. Self-beliefs were measured via self-reports, social integration via sociometric peer-nominations. The reference group (n = 288 children) included all children who did not participate in the intervention between pre-test and post-test: (a) 12 children (7 RI) of a waiting control group and (b) all classmates of both the students of the intervention and the waiting control group. Post-test self-beliefs were more positive in children having participated in the intervention. The intervention did not affect social integration: Neither the number of classmates nominating a student nor the number of peers the respective student nominated increased. Possibly, the intervention initiated self-reinforcing processes which support social integration over longer time periods.",2020,We present a school-based intervention geared to foster the social integration of recently immigrated (RI) primary school children by creating repeated positive contact situations with classmates brought up in the receiving society.,"['30 children (12 RI) who participated in our intervention between pre-test and post-test with a reference group', 'recently immigrated children', 'The reference group (n = 288 children) included all children who did not participate in the intervention between pre-test and post-test: (a) 12 children (7 RI) of a waiting control group and (b) all classmates of both the students of the intervention and the waiting control group']",['school-based intervention'],"['Self-beliefs', 'number of classmates nominating a student nor the number of peers the respective student nominated increased', 'social integration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",288.0,0.015598,We present a school-based intervention geared to foster the social integration of recently immigrated (RI) primary school children by creating repeated positive contact situations with classmates brought up in the receiving society.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hannover', 'Affiliation': 'Fachbereich Erziehungswissenschaft und Psychologie, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Kreutzmann', 'Affiliation': 'Fachbereich Erziehungswissenschaft und Psychologie, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Jannika', 'Initials': 'J', 'LastName': 'Haase', 'Affiliation': 'Fachbereich Erziehungswissenschaft und Psychologie, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Lysann', 'Initials': 'L', 'LastName': 'Zander', 'Affiliation': 'Institut für Erziehungswissenschaft, Leibniz University Hannover, Hanover, Germany.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12653']
899,30577714,"The Faith, Activity, and Nutrition (FAN) Dissemination and Implementation Study, Phase 1: Implementation Monitoring Methods and Results.","Faith-based settings offer opportunities for reaching populations at risk for chronic conditions and are optimal settings for dissemination and implementation (D&I) research. Faith, Activity, and Nutrition (FAN) is an evidence-based program designed to promote physical activity (PA) and healthy eating (HE) through church policy, systems, and environmental change. We report implementation fidelity for Phase 1 of the FAN D&I project, a countywide effort. The group randomized study included pre- and postintervention assessments of core PA and HE components. We compared implementation in early intervention ( n = 35) versus delayed intervention (control, n = 19) churches; assessed individual church implementation; and examined the effects of level of implementation on church member outcomes. Implementation assessments were conducted with the FAN coordinator via telephone survey. Study outcomes were assessed with church members 8 to 12 months following baseline assessment via self-administered surveys. We found significantly higher levels of implementation for PA opportunities, PA and HE guidelines, PA and HE messages, and PA and HE pastor support in intervention versus control churches and showed church-level variation in PA and HE implementation. PA self-efficacy varied by level of implementation; high and low implementers did not differ in proportion of church members physically inactive, although low implementers had fewer members inactive than controls. The high level of implementation in intervention churches shows promise for broader dissemination of FAN.",2019,"PA self-efficacy varied by level of implementation; high and low implementers did not differ in proportion of church members physically inactive, although low implementers had fewer members inactive than controls.",[],"['delayed intervention (control, n = 19) churches; assessed individual church implementation']","['Faith, Activity, and Nutrition (FAN', 'PA self-efficacy', 'Faith, Activity, and Nutrition (FAN) Dissemination']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0329002,"PA self-efficacy varied by level of implementation; high and low implementers did not differ in proportion of church members physically inactive, although low implementers had fewer members inactive than controls.","[{'ForeName': 'Ruth P', 'Initials': 'RP', 'LastName': 'Saunders', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Jake-Schoffman', 'Affiliation': '2 University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kinnard', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Forthofer', 'Affiliation': '3 University of North Carolina at Charlotte, Charlotte, NC, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Kaczynski', 'Affiliation': '1 University of South Carolina, Columbia, SC, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198118818235']
900,31978010,Efficacy and Safety of Sodium Benzoate in The Management of Hyperammonemia in Decompensated Chronic Liver Disease of the Childhood-A Double-blind Randomized Controlled Trial.,"OBJECTIVE
The objective was to evaluate the efficacy and safety of sodium benzoate in the management of hyperammonemia and hepatic encephalopathy (HE) in decompensated chronic liver disease.
METHODS
It was a prospective, interventional, double-blinded randomized controlled trial conducted from August 2017 to December 2018. Children with decompensated chronic liver disease and hyperammonemia were included in the study. Those with ammonia >400 μg/dL, already receiving sodium benzoate or with grade III ascites were excluded. Group A received sodium benzoate (400 mg/kg loading dose followed by 200 mg · kg · daymaintenance for 5 days) along with the standard medical therapy. Group B received standard medical therapy with placebo.
RESULTS
A total of 108 episodes of hyperammonemia occurred in 86 patients of whom 16 were excluded. The final analysis included 46 episodes in each group. The median decrease in ammonia from baseline to day 5 was 52 μg/dL in group A versus 42 μg/dL in group B (P = 0.321). There was a significant decrease in ammonia on days 1 and 2 in group A as compared to group B, but not on subsequent days. There was no significant difference in the resolution of HE (57.1% vs 50%; P = 1), but there was higher, albeit insignificant increase in ascites in group A (15.9% vs 4.5%).
CONCLUSIONS
Addition of sodium benzoate significantly reduced the ammonia levels on the first 2 days of therapy but the effect was not sustained till day 5. The effect of sodium benzoate would probably be more sustained, if higher dosage (400 mg · kg · day) could be used under monitoring of benzoate levels. There was no effect on resolution of HE. Sodium benzoate caused an increasing trend of adverse events with no effect on short-term survival.",2020,"There was no significant difference in the resolution of HE (57.1% vs 50%; P = 1), but there was higher, albeit insignificant increase in ascites in group A (15.9% vs 4.5%).
","['August 2017 to December 2018', 'A total of 108 episodes of hyperammonemia occurred in 86 patients of whom 16 were excluded', 'Children with decompensated chronic liver disease and hyperammonemia', 'decompensated chronic liver disease']","['sodium benzoate', 'sodium benzoate (400\u200amg/kg loading dose followed by 200\u200amg\u200a·\u200akg\u200a·\u200adaymaintenance for 5 days) along with the standard medical therapy', 'standard medical therapy with placebo', 'Sodium Benzoate']","['ammonia', 'Efficacy and Safety', 'resolution of HE', 'ammonia levels', 'median decrease in ammonia', 'adverse events', 'ascites']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0220994', 'cui_str': 'Hyperammonemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}]","[{'cui': 'C0142805', 'cui_str': 'Sodium Benzoate'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201879', 'cui_str': 'Ammonia measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}]",,0.418311,"There was no significant difference in the resolution of HE (57.1% vs 50%; P = 1), but there was higher, albeit insignificant increase in ascites in group A (15.9% vs 4.5%).
","[{'ForeName': 'Pandey', 'Initials': 'P', 'LastName': 'Snehavardhan', 'Affiliation': 'Department of Pediatric Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Bikrant B', 'Initials': 'BB', 'LastName': 'Lal', 'Affiliation': ''}, {'ForeName': 'Vikrant', 'Initials': 'V', 'LastName': 'Sood', 'Affiliation': ''}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': ''}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Alam', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002521']
901,31954066,Probiotics for recurrent idiopathic aphthous stomatitis in adults: a placebo-controlled randomized trial.,,2020,"Sir, recurrent idiopathic aphtosous stomatitis (RIAS) is a frequent disorder that induces a marked alteration of the quality of life of affected individuals.",['recurrent idiopathic aphthous stomatitis in adults'],"['placebo', 'Thalidomide', 'thalidomide', 'Probiotics']",[],"[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0038363', 'cui_str': 'Ulcer, Aphthous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]",[],,0.0574893,"Sir, recurrent idiopathic aphtosous stomatitis (RIAS) is a frequent disorder that induces a marked alteration of the quality of life of affected individuals.","[{'ForeName': 'P-M', 'Initials': 'PM', 'LastName': 'Dugourd', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': ""Centre Hospitalier Universitaire Nice, Délégation à la Recherche Clinique et à l'Innovation, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Velin', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Montaudié', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16199']
902,31586305,"The Prediction Model of Warfarin Individual Maintenance Dose for Patients Undergoing Heart Valve Replacement, Based on the Back Propagation Neural Network.","BACKGROUND AND OBJECTIVE
Because of the narrow therapeutic window and huge inter-individual variation, the individual precision on anticoagulant therapy of warfarin is challenging. In our study, we aimed to construct a Back Propagation Neural Network (BPNN) model to predict the individual warfarin maintenance dose among Chinese patients who have undergone heart valve replacement, and validate its prediction accuracy.
METHODS
In this study, we analyzed 13,639 eligible patients extracted from the Chinese Low Intensity Anticoagulant Therapy after Heart Valve Replacement database, which collected data on patients using warfarin after heart valve replacement from 15 centers all over China. Ten percent of patients who were finally enrolled in the database were used as the external validation, while the remaining were randomly divided into the training and internal validation groups at a ratio of 3:1. Input variables were selected by univariate analysis of the general linear model; 2.0, the mean value of the international normalized ratio (INR) range 1.5-2.5, was used as the mandatory variable. The BPNN model and the multiple linear regression (MLR) model were constructed by the training group and validated through comparisons of the mean absolute error (MAE), mean squared error (MSE), root mean squared error (RMSE), and ideal predicted percentage.
RESULTS
Finally, 10 input variables were selected and a three-layer BPNN model was constructed. In the BPNN model, the value of MAE (0.688 mg/day and 0.740 mg/day in internal and external validation, respectively), MSE (0.580 mg/day and 0.599 mg/day in internal and external validation, respectively), and RMSE (0.761 mg/day and 0.774 mg/day in internal and external validation, respectively) were achieved. Ideal predicted percentages were high in both internal (63.0%) and external validation (59.7%), respectively. Compared with the MLR model, the BPNN model showed a higher ideal prediction percentage in the external validation group (59.7% vs. 56.6%), and showed the best prediction accuracy in the intermediate-dose subgroup (internal validation group: 85.2%; external validation group: 84.7%) and a high predicted percentage in the high-dose subgroup (internal validation group: 36.2%; external validation group: 39.8%), but poor performance in the low-dose subgroup (internal validation group: 0%; external validation group: 0.3%). Meanwhile, the BPNN model showed better ideal prediction percentage in the high-dose group than the MLR model (internal validation: 36.2% vs. 31.6%; external validation: 42.8% vs. 37.8%).
CONCLUSION
The BPNN model shows promise for predicting the warfarin maintenance dose after heart valve replacement.",2020,"Ideal predicted percentages were high in both internal (63.0%) and external validation (59.7%), respectively.","['Patients Undergoing Heart', 'Ten percent of patients who were finally enrolled in the database were used as the external validation, while the remaining', 'Chinese patients who have undergone heart valve replacement', '13,639 eligible patients extracted from the Chinese Low Intensity Anticoagulant Therapy after Heart Valve Replacement database, which collected data on patients using warfarin after heart valve replacement from 15 centers all over China']","['MSE', 'warfarin']","['root mean squared error (RMSE), and ideal predicted percentage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement (procedure)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0172153,"Ideal predicted percentages were high in both internal (63.0%) and external validation (59.7%), respectively.","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Guo Xue Xiang 37#, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Career Development Division, The Fourth Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'Department of Hematology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Nutrition, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, China Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiovascular Surgery, Tianjin Central Hospital, Tianjin, China.'}, {'ForeName': 'WenZhe', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': 'Department of Social Medicine and Health Management, Shandong University, Jinan, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'JiangLong', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Guo Xue Xiang 37#, Chengdu, 610041, Sichuan, China. ebm_chenjin@126.com.'}, {'ForeName': 'Wei-Hong', 'Initials': 'WH', 'LastName': 'Zhang', 'Affiliation': 'Department of Research Laboratory for Human Reproduction, Faculty of Medicine and School of Public Health, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}]",Clinical drug investigation,['10.1007/s40261-019-00850-0']
903,31860172,Randomized controlled trial of a positive affect intervention to reduce HIV viral load among sexual minority men who use methamphetamine.,"INTRODUCTION
In the era of HIV treatment as prevention (TasP), evidence-based interventions that optimize viral suppression among people who use stimulants such as methamphetamine are needed to improve health outcomes and reduce onward transmission risk. We tested the efficacy of positive affect intervention delivered during community-based contingency management (CM) for reducing viral load in sexual minority men living with HIV who use methamphetamine.
METHODS
Conducted in San Francisco, this Phase II randomized controlled trial tested the efficacy of a positive affect intervention for boosting and extending the effectiveness of community-based CM for stimulant abstinence to achieve more durable reductions in HIV viral load. From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use were randomized to receive a positive affect intervention (n = 55) or attention-control condition (n = 55). All individual positive affect intervention and attention-control sessions were delivered during three months of community-based CM where participants received financial incentives for stimulant abstinence. The 5-session positive affect intervention was designed to provide skills for managing stimulant withdrawal symptoms as well as sensitize individuals to natural sources of reward. The attention-control condition consisted of neutral writing exercises and self-report measures.
RESULTS
Men randomized to the positive affect intervention displayed significantly lower log 10 HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition. Men in the positive affect intervention also had significantly lower risk of at least one unsuppressed HIV RNA (≥200 copies/mL) over the 15-month follow-up. There were concurrent, statistically significant intervention-related increases in positive affect as well as decreases in the self-reported frequency of stimulant use at six and twelve months.
CONCLUSIONS
Delivering a positive affect intervention during community-based CM with sexual minority men who use methamphetamine achieved durable and clinically meaningful reductions in HIV viral load that were paralleled by increases in positive affect and decreases in stimulant use. Further clinical research is needed to determine the effectiveness of integrative, behavioural interventions for optimizing the clinical and public health benefits of TasP in sexual minority men who use stimulants such as methamphetamine.",2019,"Men randomized to the positive affect intervention displayed significantly lower log 10 HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition.","['sexual minority men living with HIV who use methamphetamine', 'sexual minority men who use', 'Conducted in San Francisco', 'sexual minority men who use stimulants such as methamphetamine', 'From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use']","['positive affect intervention (n\xa0=\xa055) or attention-control condition', 'methamphetamine', 'positive affect intervention', 'neutral writing exercises and self-report measures', 'community-based contingency management (CM']","['log 10 HIV viral load', 'HIV viral load']","[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}]",,0.110968,"Men randomized to the positive affect intervention displayed significantly lower log 10 HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition.","[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Carrico', 'Affiliation': 'University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Dilworth', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Evans', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gόmez', 'Affiliation': 'Berkeley School of Social Welfare, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Jain', 'Affiliation': 'San Diego School of Medicine, University of California, La Jolla, CA, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Shoptaw', 'Affiliation': 'Departments of Family Medicine and Psychiatry, Los Angeles David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Horvath', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Coffin', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Discepola', 'Affiliation': 'San Francisco AIDS Foundation, San Francisco, CA, USA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'San Francisco AIDS Foundation, San Francisco, CA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Woods', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, CA, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25436']
904,30821866,Development and feasibility of a brief Zero-time Exercise intervention to reduce sedentary behaviour and enhance physical activity: A pilot trial.,"A brief intervention using Zero-time Exercise (ZTEx), a foot-in-the-door approach, was developed to reduce sedentary behaviour and increase physical activity. ZTEx refers to the integration of simple strength- and stamina-enhancing physical activity into daily life, which can be done anytime, anywhere and by anyone. This paper presents the development, feasibility, and preliminary evidence for the effectiveness of this intervention under the Hong Kong Jockey Club FAMILY Project. Needs assessments were conducted with social workers from the Christian Family Services Center(CFSC) and the Social Welfare Department (SWD). This single group prospective ZTEx intervention trial, guided by the Health Action Process Approach, included a 3-hr core session at baseline and a 1-hr booster session at 1-month follow-up. Fifty-six participants (social and service-related workers) from CFSC (n = 28) and SWD (n = 28) received the intervention and completed the self-administered questionnaires at baseline. Forty-nine and 43 participants completed the 1-month and 3-month self-administered questionnaires, respectively. Fifteen participants attended the focus group interviews to share their feedback on ZTEx intervention after implementing their community-based ZTEx activities. Intention-to-treat analysis was conducted with missing data replaced by baseline values. Participants reported significant decreases in sitting time by 27 (2, 52) minutes (mean [95% confidence interval]) and 36 (0.2, 71) minutes on a weekday, increases in physical activity while seated by 0.7 (0.2, 1.4) days and 1.1 (0.6, 1.7) days in a week, and improvements in perceived knowledge, outcome expectancies and plan on doing ZTEx at the 1-month and 3-month follow-up, respectively. Balance and muscle strength significantly improved at the 1-month follow-up. The effect ranged from small to large (Cohen's d: 0.27-1.05, all p < 0.05). The qualitative feedbacks support the quantitative findings. Our findings show early evidence that ZTEx effectively reduced sedentary behaviour and enhanced physical activity and fitness. Further trials on this simple and low-cost intervention as the first step to promote higher intensity exercise are warranted.",2019,"The effect ranged from small to large (Cohen's d: 0.27-1.05, all p < 0.05).",['Fifty-six participants\xa0(social and service-related workers) from CFSC'],"['ZTEx', 'Zero-time Exercise (ZTEx', 'ZTEx intervention', 'brief Zero-time Exercise intervention']","['Balance and muscle strength', 'perceived knowledge, outcome expectancies and plan on doing ZTEx', 'sedentary behaviour and increase physical activity', 'sitting time', 'sedentary behaviour and enhanced physical activity and fitness', 'sedentary behaviour and enhance physical activity', 'physical activity']","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0368678,"The effect ranged from small to large (Cohen's d: 0.27-1.05, all p < 0.05).","[{'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Lai', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Wan', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'Hong Kong Social Welfare Department, Hong Kong, SAR, China.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tse', 'Affiliation': 'Christian Family Service Centre, Hong Kong, SAR, China.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ho', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Tai-Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, SAR, China.'}]",Health & social care in the community,['10.1111/hsc.12728']
905,30540337,Interindividual Variation in Low-Density Lipoprotein Cholesterol Level Reduction With Evolocumab: An Analysis of FOURIER Trial Data.,"Importance
Little is known about the heterogeneity in low-density lipoprotein cholesterol levels (LDL-C) lowering with proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor medications.
Objective
To evaluate the interindividual variability in LDL-C reduction with the PCSK9 inhibitor drug evolocumab.
Design, Setting, and Participants
We examined the percentage change in LDL-C levels from baseline in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, a placebo-controlled randomized clinical trial of the PCSK9 inhibitor evolocumab in patients with stable atherosclerotic cardiovascular disease who were taking statin medications. Patients in either treatment arm who had high baseline LDL-C variability during screening and either did not receive the study drug, altered their background lipid-lowering therapy regimen, or had no LDL-C level sample in week 4 were excluded from the primary analysis. Analyses in the patients were stratified by treatment arm. Data was collected from 2013 to 2016, and data were analyzed from January 2018 to November 2018.
Main Outcomes and Measures
Interindividual variation in percent reduction in LDL-C with evolocumab.
Results
There were 27 564 individuals in the cohort; after exclusions for baseline variability (n = 3524) or alterations in background lipid therapy and other causes (n = 2272), 21 768 patients remained. At week 4, the median percent reduction in LDL-C levels from baseline was 66% (interquartile range, 54%-76%; median [interquartile range] baseline value, 90 [79-105] mg/dL; postchange value, 31 [21-44] mg/dL) with evolocumab. During the first year, a total of 10 325 of 10902 patients in the evolocumab group (94.7%) had a reduction 50% or greater in LDL-C levels, 10 669 of 10 902 (97.9%) had a reduction 30% or more, and 10 849 of 10 902 (99.5%) had any reduction in LDL-C levels. Fifty-three patients (0.5%) had no apparent reduction in LDL-C levels. In the placebo arm, the median LDL-C reduction was 4% (interquartile range, 6% increase to 13% reduction; baseline median [IQR] value, 90 [79-106] mg/dL; postchange value, 87 [74-103] mg/dL) at 4 weeks. Waterfall plots showed notable variability in the top and bottom 5% of patients for both evolocumab and placebo groups, with large changes in LDL-C levels in the placebo group (increases of ≥25%, 531 patients [4.9%]; decreases of ≥25%, 985 patients [9.1%]). At 4 weeks, the placebo-adjusted reductions in LDL-C levels with evolocumab were 50% or greater in 9839 of 10 866 patients (90.5%) and 30% or greater in 10 846 of 10 866 patients (99.8%). Results were consistent across clinically relevant subgroups.
Conclusions and Relevance
There appears to be a highly consistent robust reduction in LDL-C levels with evolocumab use.
Trial Registration
ClinicalTrials.gov identifier: NCT01764633.",2019,"At 4 weeks, the placebo-adjusted reductions in LDL-C levels with evolocumab were 50% or greater in 9839 of 10 866 patients (90.5%) and 30% or greater in 10 846 of 10 866 patients (99.8%).","['There were 27\u202f564 individuals in the cohort; after exclusions for baseline variability (n\u2009=\u20093524) or alterations in background lipid therapy and other causes (n\u2009=\u20092272), 21\u202f768 patients remained', 'Data was collected from 2013 to 2016, and data were analyzed from January 2018 to November 2018', 'patients with stable atherosclerotic cardiovascular disease who were taking statin medications', 'Participants', 'Patients in either treatment arm who had high baseline LDL-C variability during screening and either did not receive the study drug, altered their background lipid-lowering therapy regimen, or had no LDL-C level sample in week 4 were excluded from the primary analysis']","['PCSK9 inhibitor evolocumab', 'Evolocumab', 'placebo']","['median LDL-C reduction', 'LDL-C levels', 'LDL-C levels with evolocumab']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}]",,0.37536,"At 4 weeks, the placebo-adjusted reductions in LDL-C levels with evolocumab were 50% or greater in 9839 of 10 866 patients (90.5%) and 30% or greater in 10 846 of 10 866 patients (99.8%).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Qamar', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wasserman', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2018.4178']
906,30447946,Older Blood Is Associated With Increased Mortality and Adverse Events in Massively Transfused Trauma Patients: Secondary Analysis of the PROPPR Trial.,"STUDY OBJECTIVE
The transfusion of older packed RBCs may be harmful in critically ill patients. We seek to determine the association between packed RBC age and mortality among trauma patients requiring massive packed RBC transfusion.
METHODS
We analyzed data from the Pragmatic, Randomized Optimal Platelet and Plasma Ratios trial. Subjects in the parent trial included critically injured adult patients admitted to 1 of 12 North American Level I trauma centers who received at least 1 unit of packed RBCs and were predicted to require massive blood transfusion. The primary exposure was volume of packed RBC units transfused during the first 24 hours of hospitalization, stratified by packed RBC age category: 0 to 7 days, 8 to 14 days, 15 to 21 days, and greater than or equal to 22 days. The primary outcome was 24-hour mortality. We evaluated the association between transfused volume of each packed RBC age category and 24-hour survival, using random-effects logistic regression, adjusting for total packed RBC volume, patient age, sex, race, mechanism of injury, Injury Severity Score, Revised Trauma Score, clinical site, and trial treatment group.
RESULTS
The 678 patients included in the analysis received a total of 8,830 packed RBC units. One hundred patients (14.8%) died within the first 24 hours. On multivariable analysis, the number of packed RBCs greater than or equal to 22 days old was independently associated with increased 24-hour mortality (adjusted odds ratio [OR] 1.05 per packed RBC unit; 95% confidence interval [CI] 1.01 to 1.08): OR 0.97 for 0 to 7 days old (95% CI 0.88 to 1.08), OR 1.04 for 8 to 14 days old (95% CI 0.99 to 1.09), and OR 1.02 for 15 to 21 days old (95% CI 0.98 to 1.06). Results of sensitivity analyses were similar only among patients who received greater than or equal to 10 packed RBC units.
CONCLUSION
Increasing quantities of older packed RBCs are associated with increased likelihood of 24-hour mortality in trauma patients receiving massive packed RBC transfusion (≥10 units), but not in those who receive fewer than 10 units.",2019,"Increasing quantities of older packed RBCs are associated with increased likelihood of 24-hour mortality in trauma patients receiving massive packed RBC transfusion (≥10 units), but not in those who receive fewer than 10 units.","['678 patients included in the analysis received a total of 8,830 packed RBC units', 'Massively Transfused Trauma Patients', 'trauma patients requiring massive packed RBC transfusion', 'Subjects in the parent trial included critically injured adult patients admitted to 1 of 12 North American Level I trauma centers who received at least 1 unit of packed RBCs and were predicted to require massive blood transfusion', 'critically ill patients', 'trauma patients receiving']",['massive packed RBC transfusion'],"['transfused volume of each packed RBC age category and 24-hour survival', 'volume of packed RBC units transfused', 'sensitivity analyses', '24-hour mortality', 'number of packed RBCs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0456675', 'cui_str': 'Massive blood transfusion (procedure)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",8830.0,0.0670676,"Increasing quantities of older packed RBCs are associated with increased likelihood of 24-hour mortality in trauma patients receiving massive packed RBC transfusion (≥10 units), but not in those who receive fewer than 10 units.","[{'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Jones', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL. Electronic address: arjones3@uab.edu.'}, {'ForeName': 'Rakesh P', 'Initials': 'RP', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, AL; Center for Free Radical Biology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Marisa B', 'Initials': 'MB', 'LastName': 'Marques', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Donnelly', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Griffin', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Pittet', 'Affiliation': 'Department of Anesthesia, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Kerby', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Shannon W', 'Initials': 'SW', 'LastName': 'Stephens', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Stacia M', 'Initials': 'SM', 'LastName': 'DeSantis', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hess', 'Affiliation': 'Department of Laboratory Medicine, Harborview Medical Center, Seattle, WA.'}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of emergency medicine,['10.1016/j.annemergmed.2018.09.033']
907,29659918,Association of dairy intake with weight change in adolescents undergoing obesity treatment.,"BACKGROUND
The role of dairy products in obesity treatment for adolescents is unclear. The study purpose was to assess the association between dairy intake and changes in BMI z-score (zBMI) during adolescent obesity treatment.
METHODS
Observational study nested within a randomized control trial. Linear mixed-effects regression models were adjusted for important non-lifestyle factors then further adjusted for dietary and physical activity variables. In total, 91 adolescents were studied.
RESULTS
Each serving of total dairy (β = -0.0054, P < 0.01), unflavored milk (β = -0.012, P < 0.01), reduced fat (β = -0.0078, P < 0.05), and low fat/fat-free products (β = -0.0149, P < 0.01) was associated with a decrease in zBMI over 12 months. These associations were no longer significant after adjustment for other dietary and physical activity factors. Sugar-sweetened beverage intake was inversely associated with intake of total dairy (β = -0.186, P = 0.001), unflavored milk (β = -0.115, P = 0.003) and low fat/fat-free dairy (β = -0.125, P = 0.001).
CONCLUSIONS
Intakes of total dairy, unflavored milk, reduced fat dairy and low fat/fat-free dairy products are associated with improved obesity treatment outcomes among adolescents. This could be due to co-occurring healthy lifestyle behaviors or to replacement of other food and beverages associated with obesity, such as sugar-sweetened beverages, by dairy products.",2019,"Sugar-sweetened beverage intake was inversely associated with intake of total dairy (β = -0.186, P = 0.001), unflavored milk (β = -0.115, P = 0.003) and low fat/fat-free dairy (β = -0.125, P = 0.001).
","['adolescents undergoing obesity treatment', 'adolescent obesity treatment', '91 adolescents were studied']",[],"['zBMI', 'BMI z-score (zBMI', 'intake of total dairy', 'unflavored milk']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C4317171', 'cui_str': 'Adolescent Obesity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]",91.0,0.0488097,"Sugar-sweetened beverage intake was inversely associated with intake of total dairy (β = -0.186, P = 0.001), unflavored milk (β = -0.115, P = 0.003) and low fat/fat-free dairy (β = -0.125, P = 0.001).
","[{'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Wrotniak', 'Affiliation': 'The Children Hospital of Philadelphia, Philadelphia, PA, USA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Georger', 'Affiliation': ""D'Youville College, 320 Porter Avenue, Buffalo, NY, USA.""}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Hill', 'Affiliation': 'The Children Hospital of Philadelphia, Philadelphia, PA, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'The Children Hospital of Philadelphia, Philadelphia, PA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Stettler', 'Affiliation': 'The Children Hospital of Philadelphia, Philadelphia, PA, USA.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdy064']
908,29885777,Effect of baseline micronutrient and inflammation status on CD4 recovery post-cART initiation in the multinational PEARLS trial.,"BACKGROUND & AIMS
Nutritional deficiency and inflammation may impact CD4+ T cell recovery during combination antiretroviral therapy (cART), particularly in resource-limited settings where malnutrition is prevalent. The aim of this study was to investigate the relationship of micronutrient and inflammation biomarkers to CD4 recovery after cART initiation.
METHODS
We conducted a secondary analysis of a random sub-cohort sample (n = 270) from a multinational randomized trial of cART regimen efficacy among 1571 cART-naïve adults. We measured pre-cART serum levels of micronutrients (Vitamin A, B 6 , B 12 , D, total carotenoids, selenium, and iron) and inflammation (C-reactive protein, soluble CD14 (sCD14), IFNγ, TNFα, Interleukin-6, and C-X-C motif chemokine 10 (CXCL10/IP10), EndoCab (IgM)) biomarkers. Biomarker status (i.e. micronutrient deficiency vs. sufficiency and elevated vs. low inflammation) was defined using established cutoffs or quartiles. Mixed-effects linear regression models were used to determine the association of baseline (pre-cART) concentrations of individual biomarkers with CD4 recovery through 96 weeks post-cART initiation.
RESULTS
In models adjusting for time-dependent viral load and baseline CD4 count, age, sex, body mass index, country, treatment regimen, anemia and hypoalbuminemia status, pre-cART vitamin D deficiency was associated with lower CD4 recovery (-14.9 cells/mm 3 , 95% CI: -27.9, -1.8) compared to sufficiency. In contrast, baseline selenium deficiency (20.8 cells/mm 3 , 95% CI: 3.3, 38.3), vitamin A deficiency (35.9 cells/mm 3 , 95% CI: 17.6, 54.3) and high sCD14 (23.4 cells/mm 3 , 95% CI: 8.9, 37.8) were associated with higher CD4 recovery compared to sufficient/low inflammation status.
CONCLUSIONS
In summary, baseline vitamin D deficiency was associated with diminished CD4 recovery after cART initiation; impaired CD4 recovery may contribute to the poor clinical outcomes recently observed in individuals with vitamin D deficiency. Vitamin A, selenium and sCD14 were associated with CD4 recovery but future studies are needed to further explore these relationships.",2019,"Vitamin A, selenium and sCD14 were associated with CD4 recovery but future studies are needed to further explore these relationships.","['random sub-cohort sample (n\xa0=\xa0270', '1571 cART-naïve adults']","['cART', 'combination antiretroviral therapy (cART']","['CD4 recovery', 'baseline selenium deficiency', 'pre-cART serum levels of micronutrients (Vitamin A, B 6 , B 12 , D, total carotenoids, selenium, and iron) and inflammation (C-reactive protein, soluble CD14 (sCD14), IFNγ, TNFα, Interleukin-6, and C-X-C motif chemokine 10 (CXCL10/IP10), EndoCab (IgM)) biomarkers', 'vitamin A deficiency']","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0238421', 'cui_str': 'Selenium deficiency (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042842', 'cui_str': 'Vitamin A Deficiency'}]",,0.325259,"Vitamin A, selenium and sCD14 were associated with CD4 recovery but future studies are needed to further explore these relationships.","[{'ForeName': 'Rupak', 'Initials': 'R', 'LastName': 'Shivakoti', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: rshivak1@jhmi.edu.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Ewald', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: erewald@gmail.com.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: nikhil_jhumit@yahoo.com.'}, {'ForeName': 'Wei-Teng', 'Initials': 'WT', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: weiteng.yang@gmail.com.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kanyama', 'Affiliation': 'UNC Lilongwe, Lilongwe, Malawi. Electronic address: ckanyama@unclilongwe.org.'}, {'ForeName': 'Sandra W', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clinica Evandro Chagas, Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil. Electronic address: sandra.wagner@ipec.fiocruz.br.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': 'Hospital Nossa Senhora de Conceição, Porto Alegre, Brazil. Electronic address: breno@ghc.com.br.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand. Electronic address: khuanchai@rihes.org.'}, {'ForeName': 'Sharlaa', 'Initials': 'S', 'LastName': 'Badal-Faesen', 'Affiliation': 'Department of Medicine, University of Witwatersrand, Johannesburg, South Africa. Electronic address: sfaesen@witshealth.co.za.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'IMPACT PERU Clinical Trials Unit, Asociacion Civil Impacta Salud y Educacion, Lima, Peru. Electronic address: jrlama@impactaperu.org.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Lalloo', 'Affiliation': 'University of KwaZulu Natal, Nelson R Mandela School of Medicine, Durban, South Africa. Electronic address: umeshlalloo@gmail.com.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Zulu', 'Affiliation': 'Malawi College of Medicine - Johns Hopkins Research Project, Kachere Rehabilitation Centre, Blantyre, Malawi. Electronic address: nez4@cdc.gov.'}, {'ForeName': 'Jyoti S', 'Initials': 'JS', 'LastName': 'Pawar', 'Affiliation': 'National AIDS Research Institute, Pune, India. Electronic address: jyotispawar.pawar@gmail.com.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Riviere', 'Affiliation': 'Les Centres GHESKIO, Port-Au-Prince, Haiti. Electronic address: cynthiariviere@yahoo.com.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'YR Gaitonde Center for AIDS Research and Education, Chennai, India. Electronic address: kumarasamy@yrgcare.org.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe. Electronic address: jhakim@mweb.co.zw.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pollard', 'Affiliation': 'Department of Medicine, University of California Davis, Sacramento, CA, USA. Electronic address: rbpollard@ucdavis.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Detrick', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: bdetrick@jhmi.edu.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Balagopal', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: abalago1@jhmi.edu.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Asmuth', 'Affiliation': 'Department of Medicine, University of California Davis, Sacramento, CA, USA. Electronic address: dasmuth@ucdavis.edu.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Semba', 'Affiliation': 'Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: rdsemba@jhmi.edu.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, CO, USA. Electronic address: Thomas.Campbell@ucdenver.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golub', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: jgolub@jhmi.edu.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA. Electronic address: agupta25@jhmi.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.05.014']
909,30686586,"Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label phase 1 study.","BACKGROUND
mAb114 is a single monoclonal antibody that targets the receptor-binding domain of Ebola virus glycoprotein, which prevents mortality in rhesus macaques treated after lethal challenge with Zaire ebolavirus. Here we present expedited data from VRC 608, a phase 1 study to evaluate mAb114 safety, tolerability, pharmacokinetics, and immunogenicity.
METHODS
In this phase 1, dose-escalation study (VRC 608), conducted at the US National Institutes of Health (NIH) Clinical Center (Bethesda, MD, USA), healthy adults aged 18-60 years were sequentially enrolled into three mAb114 dose groups of 5 mg/kg, 25 mg/kg, and 50 mg/kg. The drug was given to participants intravenously over 30 min, and participants were followed for 24 weeks. Participants were only enrolled into increased dosing groups after interim safety assessments. Our primary endpoints were safety and tolerability, with pharmacokinetic and anti-drug antibody assessments as secondary endpoints. We assessed safety and tolerability in all participants who received study drug by monitoring clinical laboratory data and self-report and direct clinician assessment of prespecified infusion-site symptoms 3 days after infusion and systemic symptoms 7 days after infusion. Unsolicited adverse events were recorded for 28 days. Pharmacokinetic and anti-drug antibody assessments were completed in participants with at least 56 days of data. This trial is registered with ClinicalTrials.gov, number NCT03478891, and is active but no longer recruiting.
FINDINGS
Between May 16, and Sept 27, 2018, 19 eligible individuals were enrolled. One (5%) participant was not infused because intravenous access was not adequate. Of 18 (95%) remaining participants, three (17%) were assigned to the 5 mg/kg group, five (28%) to the 25 mg/kg group, and ten (55%) to the 50 mg/kg group, each of whom received a single infusion of mAb114 at their assigned dose. All infusions were well tolerated and completed over 30-37 min with no infusion reactions or rate adjustments. All participants who received the study drug completed the safety assessment of local and systemic reactogenicity. No participants reported infusion-site symptoms. Systemic symptoms were all mild and present only in four (22%) of 18 participants across all dosing groups. No unsolicited adverse events occurred related to mAb114 and one serious adverse event occurred that was unrelated to mAb114. mAb114 has linear pharmacokinetics and a half-life of 24·2 days (standard error of measurement 0·2) with no evidence of anti-drug antibody development.
INTERPRETATION
mAb114 was well tolerated, showed linear pharmacokinetics, and was easily and rapidly infused, making it an attractive and deployable option for treatment in outbreak settings.
FUNDING
Vaccine Research Center, US National Institute of Allergy and Infectious Diseases, and NIH.",2019,No unsolicited adverse events occurred related to mAb114 and one serious adverse event occurred that was unrelated to mAb114.,"['participants who received study drug by monitoring clinical laboratory data and self-report and direct clinician assessment of prespecified infusion-site symptoms 3 days after infusion and systemic symptoms 7 days after infusion', 'participants with at least 56 days of data', 'Between May 16, and Sept 27, 2018, 19 eligible individuals were enrolled', 'healthy adults aged 18-60 years']",[],"['Systemic symptoms', 'safety and tolerability', 'Unsolicited adverse events', 'safety assessment of local and systemic reactogenicity', 'safety and tolerability, with pharmacokinetic and anti-drug antibody assessments', 'Safety, tolerability, pharmacokinetics, and immunogenicity', 'infusion-site symptoms', 'mAb114 safety, tolerability, pharmacokinetics, and immunogenicity', 'unsolicited adverse events']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",,0.206785,No unsolicited adverse events occurred related to mAb114 and one serious adverse event occurred that was unrelated to mAb114.,"[{'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Gaudinski', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Coates', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Novik', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Widge', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine V', 'Initials': 'KV', 'LastName': 'Houser', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Eugeania', 'Initials': 'E', 'LastName': 'Burch', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'LaSonji A', 'Initials': 'LA', 'LastName': 'Holman', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carter', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Nason', 'Affiliation': 'Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sitar', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Yamshchikov', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Berkowitz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Andrews', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vazquez', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Laurencot', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Misasi', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Arnold', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Carlton', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lawlor', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gall', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McDermott', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Capparelli', 'Affiliation': 'School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Koup', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Sullivan', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: ledgerwood@mail.nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)30036-4']
910,31811950,Genetic Variant Associated with Survival of Patients with Stage II-III Colon Cancer.,"BACKGROUND & AIMS
Many genetic variants have been associated with colorectal cancer risk, although few have been associated with survival times of patients. Identification of genetic variants associated with survival times might improve our understanding of disease progression and aid in outcome prediction. We performed a genome-wide association study to identify variants associated with colon cancer survival time.
METHODS
We performed a post hoc analysis of data from NCCTG N0147 (Alliance), a randomized phase 3 trial of patients with resected stage III colon cancer, and from NSABP C-08 (NRG), a phase 3 trial that compared therapy regimens for patients with resected stage II or III colon cancer. Genotype analyses were performed on DNA from blood samples from 4974 patients. We used Cox proportional hazards regression to evaluate the association of each single nucleotide polymorphism with times of overall survival and disease-free survival, adjusting for age at diagnosis, sex, treatment group, and principal components of genetic ancestry. We performed the analysis for studies N0147 and C-08 separately, and results were combined in a fixed-effects meta-analysis.
RESULTS
A locus on chromosome 7p15.2 was significantly associated with overall survival time (P ≤ 5x10 -08 ). The most significant variant at this locus, rs76766811 (P = 1.6x10 -08 ), is common among African Americans (minor allele frequency, approximately 18%) but rare in European Americans (minor allele frequency <0.1%). Within strata of self-reported ancestry, this variant was associated with times of overall survival and disease-free survival in only African Americans (hazard ratio for overall survival, 2.82; 95% CI, 1.88-4.23; P = 5.0x10 -07 and hazard ratio for disease-free survival, 2.27; 95% CI, 1.62-3.18; P = 1.8x10 -06 ).
CONCLUSIONS
In an analysis of data from 2 trials of patients with stage II or III colon cancer, we identified rs76766811 as a potential prognostic variant in African American patients. This finding should be confirmed in additional study populations. ClinicalTrials.gov Identifiers: NCT00096278 (NSABP C-08) and NCT00079274 (NCCTG N0147).",2019,A locus on chromosome 7p15.2 was significantly associated with overall survival time (P≤5x10 -08 ).,"['African American patients', '4974 patients', 'patients with resected stage III colon cancer, and from NSABP C-08 (NRG), a phase 3 trial that compared therapy regimens for patients with resected stage II or III colon cancer', 'patients with stage II or III colon cancer', 'Patients with Stage II-III Colon Cancer']",[],"['overall survival time', 'overall survival and disease-free survival', 'colon cancer survival time']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]",4974.0,0.294248,A locus on chromosome 7p15.2 was significantly associated with overall survival time (P≤5x10 -08 ).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Penney', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Banbury', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Bien', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Tabitha A', 'Initials': 'TA', 'LastName': 'Harrison', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Amanda I', 'Initials': 'AI', 'LastName': 'Phipps', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Amit D', 'Initials': 'AD', 'LastName': 'Joshi', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Carmen J', 'Initials': 'CJ', 'LastName': 'Allegra', 'Affiliation': 'University of Florida, Gainesville, Florida; NRG Oncology, Pittsburgh, Pennsylvania.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Atkins', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Colangelo', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'George', 'Affiliation': 'University of Florida, Gainesville, Florida; NRG Oncology, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Suresh G', 'Initials': 'SG', 'LastName': 'Nair', 'Affiliation': 'Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota; Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Yothers', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Polly A', 'Initials': 'PA', 'LastName': 'Newcomb', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: achan@mgh.harvard.edu.""}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.11.046']
911,31982219,"Is it feasible ""scoop and run while playing"" resuscitation on a rescue water craft? A randomized simulation study with lifeguards.","OBJECTIVE
Response time is a predictive factor for survival of drowning victims and lifesaving. Rescue Water Craft (RWC) are lifeboats very common in lifeguards operations. The aim of this study was to analyze the feasibility of providing effective mouth-to-mouth ventilations and/or cardiopulmonary resuscitation (CPR) on the RWC while sailing at different speeds.
METHOD
A quasi-experimental cross-over block design was used to test during one minute efforts the effectiveness of Mouth to Mouth ventilation (MM-only) and CRP, at the beach and sailing at two diferents speeds 5 knots(kn) and 10 kn with calm sea. Quality CPR reference were 2015 ERC guidelines.
RESULTS
The data obtained from 13 lifeguards were included, that means that 78 resuscitation test were completed. The MM-only performance skills reached 69.7% ± 40.4 for 5 kn and 60.0% ± 41.8 for 10 kn (p = .59). For full CPR, performance was 74.4% ± 24.2 and 68.5% ± 23.9 respectively. Quality of MM and CPR decreased, not significantly, while sailing at 5 kn and 10 kn [(Q-MM; 5 kn: 59.9% ± 37.8 vs. 10 kn: 43.2% ± 41.4, p = .42)(Q-CPR; 5 kn: 64.8% ± 21.2 and 10 kn: 60.6% ± 21.0, p = .44)]. MM-only and CC variables were significantly worse on RJS when compared with resuscitation at the beach (p < .05). A trend for better results by lifeguards previously training on RJS was observed.
CONCLUSIONS
Resuscitation techniques on board of a RWC are feasible and therefore they could be an option for lifeguards when their training, sea conditions, distance and the victim's characteristics allow it. CPR maneuvers may be highly effective at 10 kn, both for MM-only and CPR, however, the quality of the ventilations dramatically worsen with increasing speed.",2020,"For full CPR, performance was 74.4% ± 24.2 and 68.5% ± 23.9 respectively.","['13 lifeguards were included, that means that 78 resuscitation test were completed']","['mouth ventilations and/or cardiopulmonary resuscitation (CPR', 'Mouth to Mouth ventilation (MM-only) and CRP, at the beach and sailing at two diferents speeds 5 knots(kn) and 10 kn with calm sea', 'Rescue Water Craft (RWC']","['MM-only performance skills', 'Quality of MM and CPR', 'Quality CPR reference']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0331781', 'cui_str': 'Beach (environment)'}, {'cui': 'C0522727', 'cui_str': 'Sailing'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]",,0.0407647,"For full CPR, performance was 74.4% ± 24.2 and 68.5% ± 23.9 respectively.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Barcala-Furelos', 'Affiliation': 'REMOSS Research Group, International Drowning Research Alliance-IDRA (Spain), Faculty of Education and Sport Sciences, Universidade de Vigo, Spain; CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain. Electronic address: roberto.barcala@uvigo.es.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Abelairas-Gomez', 'Affiliation': 'CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain; Faculty of Education, Universidade de Santiago de Compostela, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Aranda-García', 'Affiliation': ""GRAFiS Research Group, Institut Nacional d'Educació Física de Catalunya, Universitat de Barcelona (UB), Barcelona, Spain.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Lorenzo-Martínez', 'Affiliation': 'REMOSS Research Group, International Drowning Research Alliance-IDRA (Spain), Faculty of Education and Sport Sciences, Universidade de Vigo, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Martínez-Isasi', 'Affiliation': 'CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Durán-Álvarez', 'Affiliation': 'Noia Health Center, SERGAS, Noia, A Coruña, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Palacios-Aguilar', 'Affiliation': 'Faculty of Sport Sciences and Physical Activity, Universidade da Coruña, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rodríguez-Núñez', 'Affiliation': 'CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.10.045']
912,29343089,Peer characteristics associated with improved glycemic control in a randomized controlled trial of a reciprocal peer support program for diabetes.,"OBJECTIVE
In a secondary analysis of a randomized controlled trial of diabetes reciprocal peer support, we examined characteristics of peers associated with improvements in their partner's glycemic control.
METHODS
A total of 102 adults with diabetes were randomized to the reciprocal peer support arm (vs. a nurse care management arm). The primary outcome was change in A1c over six months. Intermediate outcomes were insulin initiation and peer engagement. A number of baseline characteristics of peers were hypothesized to influence outcomes for their peer, and concordant characteristics of peer dyads were hypothesized that would influence outcomes for both peer partners.
RESULTS
Improvement in A1c was associated with having a peer older than oneself ( P < .05) or with higher diabetes-related distress ( P < .01). Participants with peers who reported poorer health at baseline had worse glycemic control at follow-up ( P < .01). Hypothesized concordant characteristics were not associated with A1c improvements. Participants whose peers had a more controlled self-regulation style were more likely to initiate insulin ( P < .05).
DISCUSSION
The improved outcomes of peers whose partners were older and reported more diabetes distress at baseline supports the need for further research into the peer characteristics that lead to improved outcomes. This could allow for better matching and more effective partnerships.",2019,Participants with peers who reported poorer health at baseline had worse glycemic control at follow-up ( P < .01).,['102 adults with diabetes'],['reciprocal peer support program'],"['diabetes distress', 'glycemic control', 'controlled self-regulation style', 'insulin initiation and peer engagement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",102.0,0.11209,Participants with peers who reported poorer health at baseline had worse glycemic control at follow-up ( P < .01).,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kaselitz', 'Affiliation': '1 12266 University of Michigan Medical School , Ann Arbor, MI, USA.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': '3 Department of Family and Preventive Medicine, 12239 Emory University School of Medicine , Atlanta, GA, USA.'}, {'ForeName': 'Hwajung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': '4 Department of Internal Medicine, 12266 University of Michigan Medical School , Ann Arbor, MI, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': '1 12266 University of Michigan Medical School , Ann Arbor, MI, USA.'}]",Chronic illness,['10.1177/1742395317753884']
913,31973960,Effects of an Individualized Fasting Program on Fasting Time and Comfort in Infants and Young Children During the Perioperative Period.,"PURPOSE
The study was designed to evaluate the effect of an individualized fasting program on fasting time and comfort in infants and young children during the perioperative period.
DESIGN
A quasiexperimental design was used.
METHODS
The study included 675 children (intervention = 353, control = 322). Data collection tools included Characteristics of Children Form and the Infant Hunger Rating Scale. The fasting program included individualized fasting education and fasting in batches. On the day of the operation, clear liquids were fed 2 hours before surgery and refed after the patient woke after surgery.
FINDINGS
The duration of perioperative fasting and the time to refeeding were shorter, the hunger scores were lower in the intervention group than those in the control group (P < .05). There was no difference in the incidence of vomiting between the two groups (P > .05), and no coughing and bloating occurred.
CONCLUSIONS
The fasting program for infants and young children can shorten the duration of fasting and can reduce the degree of hunger. This program is safe and feasible.",2020,"The duration of perioperative fasting and the time to refeeding were shorter, the hunger scores were lower in the intervention group than those in the control group (P < .05).","['Infants and Young Children', 'infants and young children during the perioperative period', '675 children (intervention\xa0=\xa0353, control\xa0=\xa0322', 'infants and young children']","['individualized fasting program', 'Individualized Fasting Program']","['Infant Hunger Rating Scale', 'incidence of vomiting', 'fasting time and comfort', 'hunger scores', 'duration of perioperative fasting and the time to refeeding', 'coughing and bloating', 'Fasting Time and Comfort']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0222045'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}]",675.0,0.0128534,"The duration of perioperative fasting and the time to refeeding were shorter, the hunger scores were lower in the intervention group than those in the control group (P < .05).","[{'ForeName': 'Canping', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China. Electronic address: 6201005@zju.edu.cn.""}, {'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': ""Department of Respiratory, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Shoujiang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Shuangping', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.08.014']
914,30063297,"A Randomized, Double-Blind, Single-Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants.","Albiglutide, developed for treatment of type 2 diabetes mellitus, is provided in a dual-chamber cartridge (DCC) single-dose pen-injector containing lyophilized drug that must be reconstituted with diluent prior to use. A liquid formulation of albiglutide has been developed that does not require mixing. In this 2-period, randomized, crossover, double-blind, phase I study (NCT02660736) in 59 healthy volunteers, pharmacokinetic parameters were determined and the bioequivalence of the 2 formulations was assessed. Participants received injections from each type of pen-injector, one containing albiglutide 50 mg and one containing placebo, followed by an 8-week washout period between regimens: albiglutide 50-mg liquid formulation from an auto-injector and lyophilized placebo from a DCC pen-injector (Regimen A), or placebo liquid from an auto-injector and lyophilized albiglutide 50 mg from a DCC pen-injector (Regimen B). Geometric mean total exposures (area under the drug concentration-time curve [AUC] (0-t) [1345.4 vs 1426.9 (μg · h/mL)], AUC (0-∞) [1376.2 vs 1454.6 (μg · h/mL)], and maximum concentration of drug in blood plasma [4968.5 vs 5314.7 ng/mL]) were comparable between Regimens A and B. Ratios of geometric least square means (90% confidence interval) were 95.3% (89.49-101.52) for AUC (0-∞) , 95.1% (89.12-101.49) for AUC (0-t) , and 93.2% (86.76-100.17) for maximum concentration of drug in blood plasma, falling within the 90% confidence interval of 0.80 to 1.25 for bioequivalence. No new safety concerns were observed.",2019,No new safety concerns were observed.,"['type 2 diabetes mellitus', 'Healthy Adult Participants', '59 healthy volunteers']","['albiglutide 50\xa0mg and one containing placebo', 'lyophilized placebo from a DCC pen-injector (Regimen A), or placebo liquid from an auto-injector and lyophilized albiglutide 50\xa0mg from a DCC pen-injector (Regimen B']","['Geometric mean total exposures (area under the drug concentration-time curve [AUC', 'maximum concentration of drug in blood plasma']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2607479', 'cui_str': 'albiglutide'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4025916', 'cui_str': 'Pen Injector'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C2984091', 'cui_str': 'Auto-Injector'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",59.0,0.385196,No new safety concerns were observed.,"[{'ForeName': 'Bonnie C', 'Initials': 'BC', 'LastName': 'Shaddinger', 'Affiliation': 'Clinical Development, GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Vlasakakis', 'Affiliation': 'Research and Development, GlaxoSmithKline, London, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Soffer', 'Affiliation': 'Clinical Development, GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Karl M', 'Initials': 'KM', 'LastName': 'Thorpe', 'Affiliation': 'Pharma Research and Development, GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hatch', 'Affiliation': 'Biostatistics, Early Development Services, PPD Development Inc, Wilmington, NC, USA.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Nino', 'Affiliation': 'Clinical Development, GlaxoSmithKline, Collegeville, PA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.606']
915,31548792,Effects of High-Intensity Interval Training Versus Moderate-Intensity Training on Cardiometabolic Health Markers in Individuals With Spinal Cord Injury: A Pilot Study.,"Background: Recent studies in nondisabled individuals have demonstrated that low-volume high-intensity interval training (HIIT) can improve cardiometabolic health similar to moderate-intensity training (MIT) despite requiring 20% of the overall time commitment. To date, there have been no studies assessing the effects of HIIT for improving cardiometabolic health in individuals with SCI. Objectives: The primary purpose of this pilot study was to compare the effects of 6 weeks of low-volume HIIT vs MIT using arm crank ergometer exercise to improve body composition, cardiovascular fitness, glucose tolerance, blood lipids, and blood pressure in a cohort of individuals with longstanding SCI. Methods: Participants were randomized to 6 weeks of HIIT or MIT arm crank exercise training. Aerobic capacity, muscular strength, blood lipids, glucose tolerance, blood pressure, and body composition were assessed at baseline and 6 weeks post training. Results: Seven individuals (6 male, 1 female; n = 3 in MIT and n = 4 in HIIT; mean age 51.3 ± 10.5 years) with longstanding SCI completed the study. The preliminary findings from this pilot study demonstrated that individuals with SCI randomized to either 6 weeks of HIIT or MIT displayed improvements in (a) insulin sensitivity, (b) cardiovascular fitness, and (c) muscular strength ( p < .05). However, MIT led to greater improvements in arm fat percent and chest press strength compared to HIIT ( p < .05). Conclusion: No differences between MIT and HIIT were observed. Both conditions led to improvements in insulin sensitivity, aerobic capacity, muscle strength, and blood lipids in individuals with SCI. Future larger cohort studies are needed to determine if the shorter amount of time required from HIIT is preferable to current MIT exercise recommendations.",2019,"However, MIT led to greater improvements in arm fat percent and chest press strength compared to HIIT ( p < .05). ","['individuals with longstanding SCI', 'Individuals With Spinal Cord Injury', 'individuals with SCI', 'Seven individuals (6 male, 1 female; n = 3 in MIT and n = 4 in HIIT; mean age 51.3 ± 10.5 years) with longstanding SCI completed the study']","['HIIT or MIT', 'HIIT or MIT arm crank exercise training', 'HIIT', 'low-volume HIIT vs MIT using arm crank ergometer exercise', 'High-Intensity Interval Training Versus Moderate-Intensity Training', 'MIT']","['cardiometabolic health', 'Cardiometabolic Health Markers', 'Aerobic capacity, muscular strength, blood lipids, glucose tolerance, blood pressure, and body composition', 'insulin sensitivity, aerobic capacity, muscle strength, and blood lipids', 'insulin sensitivity, (b) cardiovascular fitness, and (c) muscular strength', 'body composition, cardiovascular fitness, glucose tolerance, blood lipids, and blood pressure']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",7.0,0.0662385,"However, MIT led to greater improvements in arm fat percent and chest press strength compared to HIIT ( p < .05). ","[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Graham', 'Affiliation': 'Department of Human Studies, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Yarar-Fisher', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Science, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Science, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'McCully', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, Georgia.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Rimmer', 'Affiliation': 'UAB/Lakeshore Foundation Research Collaborative, Birmingham, Alabama.'}, {'ForeName': 'Danille', 'Initials': 'D', 'LastName': 'Powell', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Science, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'C Scott', 'Initials': 'CS', 'LastName': 'Bickel', 'Affiliation': 'Department of Physical Therapy, Samford University, Birmingham, Alabama.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fisher', 'Affiliation': 'Department of Human Studies, University of Alabama at Birmingham, Birmingham, Alabama.'}]",Topics in spinal cord injury rehabilitation,['10.1310/sci19-00042']
916,31548793,Dual-Task Obstacle Crossing Training Could Immediately Improve Ability to Control a Complex Motor Task and Cognitive Activity in Chronic Ambulatory Individuals With Spinal Cord Injury.,"Background: The effectiveness of dual-task training has been reported in individuals with cognitive impairments. To date, there is no clear evidence on the incorporation of dual-task training in ambulatory individuals with spinal cord injury (SCI) who have intact cognitive functions but have various degrees of sensorimotor dysfunction. Objectives: To compare the immediate effects of dual-task obstacle crossing (DTOC) and single-task obstacle crossing (STOC) training on functional and cognitive abilities in chronic ambulatory participants with SCI. Methods: This is a randomized 2 × 2 crossover design with blinded assessors. Twenty-two participants were randomly trained using a 30-minute DTOC and STOC training program with a 2-day washout period. Outcomes, including 10-Meter Walk Tests (single- and dual-task tests), percent of Stroop Color and Word Test task errors, Timed Up and Go Test (TUG), and five times sit-to-stand test, were measured immediately before and after each training program. Results: Participants showed significant improvement in all outcomes following both training programs ( p < .05), except percent of Stroop Color and Word Test task errors after STOC training. Obvious differences between the training programs were found for the percent of Stroop task errors and TUG ( p s = .014 and .06). Conclusion: Obstacle crossing is a demanding task, thus the obvious improvement was found immediately after both training programs in participants with long post-injury time (approximately 5 years). However, the findings primarily suggest the superior effects of DTOC over STOC on a complex motor task and cognitive activity. A further randomized control trial incorporating a complex dual-task test is needed to strengthen evidence for the benefit of DTOC for these individuals.",2019,"Participants showed significant improvement in all outcomes following both training programs ( p < .05), except percent of Stroop Color and Word Test task errors after STOC training.","['chronic ambulatory participants with SCI. Methods', 'individuals with cognitive impairments', 'Chronic Ambulatory Individuals With Spinal Cord Injury', 'ambulatory individuals with spinal cord injury (SCI']","['dual-task training', '30-minute DTOC and STOC training program', 'dual-task obstacle crossing (DTOC) and single-task obstacle crossing (STOC) training']","['Stroop Color and Word Test task errors', '10-Meter Walk Tests (single- and dual-task tests), percent of Stroop Color and Word Test task errors, Timed Up and Go Test (TUG), and five times sit-to-stand test', 'functional and cognitive abilities', 'complex motor task and cognitive activity']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",22.0,0.0195197,"Participants showed significant improvement in all outcomes following both training programs ( p < .05), except percent of Stroop Color and Word Test task errors after STOC training.","[{'ForeName': 'Sugalya', 'Initials': 'S', 'LastName': 'Amatachaya', 'Affiliation': 'School of Physical Therapy, Khon Kaen University, Maung, Khon Kaen, Thailand.'}, {'ForeName': 'Kitiyawadee', 'Initials': 'K', 'LastName': 'Srisim', 'Affiliation': 'School of Physical Therapy, Khon Kaen University, Maung, Khon Kaen, Thailand.'}, {'ForeName': 'Preeda', 'Initials': 'P', 'LastName': 'Arrayawichanon', 'Affiliation': 'Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thiwabhorn', 'Initials': 'T', 'LastName': 'Thaweewannakij', 'Affiliation': 'School of Physical Therapy, Khon Kaen University, Maung, Khon Kaen, Thailand.'}, {'ForeName': 'Pipatana', 'Initials': 'P', 'LastName': 'Amatachaya', 'Affiliation': 'Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand.'}]",Topics in spinal cord injury rehabilitation,['10.1310/sci18-00038']
917,30818032,"Immune-inflammatory pathways and clinical changes in fibromyalgia patients treated with Mindfulness-Based Stress Reduction (MBSR): A randomized, controlled clinical trial.","Fibromyalgia (FM) is a highly prevalent and disabling syndrome characterized by chronic widespread musculoskeletal pain and a broad range of cognitive and affective symptoms. Up to now, the pathogenesis of FM is unknown although a peripheral and central sensitization involving an imbalance on immune biomarkers appears to have a relevant role in its aetiology. The aim of this study was to extend previous clinical findings of Mindfulness-Based Stress Reduction (MBSR) to both its impact on clinical symptomatology and immune biomarkers (IL-6, CXCL8, IL-10 and hs-CRP), and also to explore the role of biomarkers as predictors of efficacy.
METHODS
A total of 70 female patients with FM were randomly assigned to two treatment modalities, namely Treatment as Usual (TAU) plus MBSR (n = 35) or TAU alone (n = 35). This study is embedded within a larger RCT (n = 225) that includes three study arms (TAU; TAU plus MBSR; and TAU plus the psychoeducative intervention FibroQoL), and a 12-month follow-up (clinical trial registration: NCT02561416). Blood cytokine assays and clinical assessment were conducted at baseline and post-treatment. Treatment effects were analysed using linear mixed models with intention to treat and per protocol analyses. In order to evaluate the balance between pro- and anti-inflammatory pathways, ratios of pro-inflammatory IL-6, CXCL8 and hs-CRP with the anti-inflammatory cytokine IL-10 were calculated (i.e. IL-6/IL-10, CXCL8/IL10 and hs-CRP/IL-10).
RESULTS
The results show that MBSR is an efficacious intervention to reduce clinical severity of patients with FM. MBSR also prevents the tendency of IL-10 to decrease as observed in the TAU group. Higher levels of baseline CXCL8 levels attenuate the beneficial effect of MBSR practice on clinical symptomatology, including pain, energy, stiffness or quality of sleep. Furthermore, higher baseline IL-6/IL-10 and CXCL8/IL-10 ratios were associated with less improvement in psychological inflexibility following MBSR treatment.
DISCUSSION
Our results show that mindfulness training has clinical efficacy in patients with FM. The results suggest that MBSR has significant immune regulatory effects in FM patients, while immune-inflammatory pathways may in part predict the clinical efficacy of MBSR. These cytokines and chemokines may be adequate biomarkers to monitor responsivity to MBSR.",2019,"Higher levels of baseline CXCL8 levels attenuate the beneficial effect of MBSR practice on clinical symptomatology, including pain, energy, stiffness or quality of sleep.","['70 female patients with FM', 'fibromyalgia patients treated with', 'patients with FM']","['namely Treatment as Usual (TAU) plus MBSR (n\u202f=\u202f35) or TAU alone', 'mindfulness training', 'Mindfulness-Based Stress Reduction (MBSR', 'MBSR']","['Blood cytokine assays and clinical assessment', 'clinical efficacy', 'balance between pro- and anti-inflammatory pathways, ratios of pro-inflammatory IL-6, CXCL8 and hs-CRP with the anti-inflammatory cytokine IL-10', 'baseline IL-6/IL-10 and CXCL8/IL-10 ratios', 'clinical symptomatology, including pain, energy, stiffness or quality of sleep', 'clinical symptomatology and immune biomarkers (IL-6, CXCL8, IL-10 and hs-CRP', 'psychological inflexibility']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0005768'}, {'cui': 'C0201576', 'cui_str': 'Cytokine assay'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",70.0,0.0876541,"Higher levels of baseline CXCL8 levels attenuate the beneficial effect of MBSR practice on clinical symptomatology, including pain, energy, stiffness or quality of sleep.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andrés-Rodríguez', 'Affiliation': 'Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain; Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, Spain; Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain; Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Borràs', 'Affiliation': 'Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain; Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, Spain; Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain; Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain. Electronic address: a.feliu@pssjd.org.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Pérez-Aranda', 'Affiliation': 'Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain; Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, Spain; Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Rozadilla-Sacanell', 'Affiliation': 'Department of Rheumatology, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maes', 'Affiliation': 'Department of Psychiatry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain; Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, Spain; Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain. Electronic address: jvluciano@pssjd.org.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.02.030']
918,31013372,Parent and child perception of quality of life in a randomized controlled peanut oral immunotherapy trial.,"BACKGROUND
Improved quality of life (QoL) after oral immunotherapy (OIT) in peanut allergic children is often reported by their parents, while the child's perspective is less clear.
OBJECTIVE
We aimed to explore whether 2 years of OIT improved QoL in children with peanut allergy and to identify factors influencing change in QoL.
METHODS
In the open-labeled TAKE-AWAY peanut OIT trial including children with anaphylaxis to peanuts, 57 were randomized to OIT and 20 to observation. The Pediatric Quality of Life Inventory Version 4.0 was completed by parents and children at enrollment (Y 0 ), after 1 year (end of updosing; Y 1 ) and after 2 years (Y 2 ) of OIT. Minimally clinically important difference (MCID) is ≥5.3. Perceived treatment burden was recorded by visual analogue scales, including adverse events (AEs). An open food challenge (OFC) was performed at Y 2 .
RESULTS
At Y 2 , 18 children had discontinued OIT and 2 of 39 OIT children refused OFC, while 35 of 37 were desensitized to 7500 mg peanut protein. From Y 0 to Y 2, the mean change (95% confidence intervals) in QoL was 4.4 (0.5, 8.3) among child self-reports and twice as large among parental proxy reports (9.3 [4.3, 14.3]; both P < 0.0001), without significant improvement among the controls. The change in QoL was significantly different from the controls for the parental proxy reports only (P = 0.002). Neither treatment burden nor AEs significantly predicted changes in QoL.
CONCLUSION
Two years of OIT improved child-QoL as reported by parents, but not by the children, suggesting that parents may overestimate improvement in child-QoL by OIT.",2019,The change in QoL was significantly different from the controls for the parental proxy-reports only (p=0.002).,"['children with peanut allergy', 'peanut allergic children', 'children with anaphylaxis to peanuts, 57 were randomized to OIT and 20 to observation']",['oral immunotherapy (OIT'],"['child-QoL', 'Parent and child perception of quality of life', 'visual analogue scales, including adverse events (AEs', 'change in QoL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034380'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",18.0,0.143224,The change in QoL was significantly different from the controls for the parental proxy-reports only (p=0.002).,"[{'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Reier-Nilsen', 'Affiliation': 'Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Karin C Lødrup', 'Initials': 'KCL', 'LastName': 'Carlsen', 'Affiliation': 'Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Merethe Melbye', 'Initials': 'MM', 'LastName': 'Michelsen', 'Affiliation': 'Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Drottning', 'Affiliation': 'Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kai-Håkon', 'Initials': 'KH', 'LastName': 'Carlsen', 'Affiliation': 'Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Magnus P', 'Initials': 'MP', 'LastName': 'Borres', 'Affiliation': 'Thermo-Fisher Scientific, Uppsala, Sweden.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Håland', 'Affiliation': 'Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13066']
919,31045329,"Effect of locally produced complementary foods on fat-free mass, linear growth, and iron status among Kenyan infants: A randomized controlled trial.","The impact of quality complementary food products on infant growth and body composition has not been adequately investigated. This study evaluated the effect on fat-free mass (FFM) accrual, linear growth, and iron status of locally produced complementary food products comparing to a standard product. In a randomized, double-blind trial, 499 infants at 6 months received nine monthly rations of (a) WinFood Classic (WFC) comprising germinated amaranth (71%), maize (10.4%), small fish (3%), and edible termites (10%); (b) WinFood Lite (WFL) comprising germinated amaranth (82.5%), maize (10.2%), and multimicronutrient premix; or (c) fortified corn-soy blend plus (CSB+). Primary outcomes were changes in FFM, length, and plasma ferritin and transferrin receptors (TfR). FFM was determined using deuterium dilution. Analysis was by intention to treat, based on available cases. Compared with CSB+, there were no differences in change from 6 to 15 months in FFM for WFC 0.0 kg (95% CI [-0.30, 0.29]) and WFL 0.03 kg (95% CI [-0.25, 0.32]) and length change for WFC -0.3 cm (95% CI [-0.9, 0.4]) and WFL -0.3 cm (95% CI [-0.9, 0.3]). TfR increased in WFC group 3.3 mg L -1 (95% CI [1.7, 4.9]) and WFL group 1.7 mg L -1 (95% CI [0.1, 3.4]) compared with CSB+. Compared with the increase in Hb in CSB+ group, there was a reduction in Hb in WFC of -0.9 g dl -1 (95% CI [-1.3, -0.5]) and a lower increase in WFL -0.4 g dl -1 (95% CI [-0.8, 0.0]). In conclusion, the tested WinFoods had the same effect on FFM and length as CSB+, whereas Hb and iron status decreased, suggesting inhibited iron bioavailability from the amaranth-based WinFoods.",2019,TfR increased in WFC group,"['499 infants at 6\xa0months received', 'Kenyan infants']","['WFC', 'locally produced complementary foods', 'WinFood Lite (WFL', 'g\xa0dl -1', 'WFL', 'multimicronutrient premix; or (c) fortified corn-soy blend plus (CSB', 'nine monthly rations of (a) WinFood Classic (WFC']","['FFM and length as CSB', 'TfR', 'fat-free mass (FFM) accrual, linear growth, and iron status', 'FFM', 'length change for WFC', 'iron bioavailability', 'WFL', 'changes in FFM, length, and plasma ferritin and transferrin receptors (TfR', 'fat-free mass, linear growth, and iron status']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0034845', 'cui_str': 'Transferrin Receptor'}]",499.0,0.502662,TfR increased in WFC group,"[{'ForeName': 'Silvenus O', 'Initials': 'SO', 'LastName': 'Konyole', 'Affiliation': 'Department of Nutritional Sciences, Masinde Muliro University of Science and Technology, Kakamega, Kenya.'}, {'ForeName': 'Selina A', 'Initials': 'SA', 'LastName': 'Omollo', 'Affiliation': 'Institute of Tropical and Infectious Diseases, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Kinyuru', 'Affiliation': 'Department of Food Science and Technology, Jomo Kenyatta University of Agriculture and Technology, Juja, Kenya.'}, {'ForeName': 'Jutta K H', 'Initials': 'JKH', 'LastName': 'Skau', 'Affiliation': 'Department of Paediatrics, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Bethwell O', 'Initials': 'BO', 'LastName': 'Owuor', 'Affiliation': 'Biological Sciences Department, Kisii University, Kisii, Kenya.'}, {'ForeName': 'Benson B', 'Initials': 'BB', 'LastName': 'Estambale', 'Affiliation': 'Division of Research, Innovations and Outreach, Jaramogi Oginga Odinga University of Science and Technology, Bondo, Kenya.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Filteau', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Friis', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Roos', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Victor O', 'Initials': 'VO', 'LastName': 'Owino', 'Affiliation': 'Nutritional and Health Related Environmental Studies Section, International Atomic Energy Agency, Vienna, Austria.'}]",Maternal & child nutrition,['10.1111/mcn.12836']
920,29757375,Establishing the Feasibility of a Tablet-Based Consent Process with Older Adults: A Mixed-Methods Study.,"Purpose of the Study
This mixed-methods study explored the feasibility and acceptability of using a tablet-based research consent process with adults aged ≥65 years.
Design and Methods
In the first phase, focus group participants reported on their perceptions of a tablet-based consent process. In the second phase, older adults were randomized to view either a tablet-based or paper-based consent for a mock clinical trial. Measurements included: time to complete, adverse/unexpected events, user-friendliness, immediate comprehension, and retention at a 1-week delay.
Results
Focus group participants (N = 15) expressed interest in the novel format, cautioning that peers would need comprehensive orientation to use the technology. In the randomized pilot (N = 20), retention was 100% and all participants completed the protocol without the occurrence of adverse/unexpected events. Although the participants took longer to complete the tablet-based consent than the paper-based version, user-friendliness, immediate comprehension, and retention of the tablet-based consent were similar to the paper-based consent.
Discussion and Implications
The findings suggest that a tablet-based consent process is feasible to implement with older adults and acceptable to this population, but we would underscore that efforts to optimize design of tablet-based consent forms for older adults are warranted.",2019,"Measurements included: time to complete, adverse/unexpected events, user-friendliness, immediate comprehension, and retention at a 1-week delay.
","['older adults', 'Older Adults', 'adults aged ≥65 years']",['tablet-based or paper-based consent'],"[' time to complete, adverse/unexpected events, user-friendliness, immediate comprehension, and retention at a 1-week delay']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",,0.0331594,"Measurements included: time to complete, adverse/unexpected events, user-friendliness, immediate comprehension, and retention at a 1-week delay.
","[{'ForeName': 'Nimali', 'Initials': 'N', 'LastName': 'Jayasinghe', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'B Isabel', 'Initials': 'BI', 'LastName': 'Moallem', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Kakoullis', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Mary-Jane', 'Initials': 'MJ', 'LastName': 'Ojie', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Sar-Graycar', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'M Cary', 'Initials': 'MC', 'LastName': 'Reid', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}]",The Gerontologist,['10.1093/geront/gny045']
921,31980416,Is Dual-Axis Rotational Coronary Angiography Radiation Dose Reduction Achievable in a Population with 100% Suspected Coronary Artery Disease? A Randomized Trial.,"BACKGROUND
Previous studies have shown a reduction in radiation dose and contrast volume using dual-axis rotational coronary angiography (DARCA), but this has not been replicated in a population with 100% coronary artery disease (CAD).
OBJECTIVE
To find if DARCA dose reduction is achievable in this population, we sought to compare the radiation dose, contrast volume, and procedure time between DARCA and conventional coronary angiography (CCA) techniques in a setting characterized by a prevalence of 100% suspected coronary artery disease.
METHODS
An all-comer, prospective, randomized, open-label trial was conducted. Cine acquisition dose-area product (DAP), cumulative air kerma (AK), effective dose (E), fluoroscopic time, contrast volume, AK, cine acquisition DAP (CADAP), fluoroscopic DAP (F-DAP), and total DAP were compared between DARCA and CCA groups.
RESULTS
We included 503 consecutive patients with suspected CAD. 252 were assigned to DARCA and 251 to CCA. Stable coronary artery disease was reported in 465 cases and non-ST elevation acute coronary syndrome in 38. Mean age: 61.88 ± 11.2 years, male gender 70.2%. DARCA arm patients showed lower total E dose (6.85 [4.55-10.83] vs. 7.91 [5.58-11.94] Sv; P = .0023), and cine E (3.00 [2.00-4.00] vs. 4.00 [3.00-5.00] Sv; P < .0001). Total DAP was also lower (40.3 [26.8-63.7] vs. 46.5 [32.8-70.2] Gycm 2 ; P = .0023), as a consequence of a lower CADAP (16.3 [10.5-22.9] vs. 23.4 [17.4-32.0] Gycm 2 ; P < .0001), with lower AK (367 [248-1497] vs. 497 [381-1827] mGy; P < .0001), with less contrast medium used (90 [60.0-106.0] vs. 100 [75.0-120.0] mL; P = .014).
CONCLUSION
In a population with 100% suspected coronary artery disease, DARCA provides accurate information required in CAD, is safe, and results in a significant decrease in contrast material volume and radiation dose compared with CCA. The required extra projections did not neutralize the DARCA radiation dose and contrast volume reduction achievements.",2020,"Total DAP was also lower (40.3 [26.8-63.7] vs. 46.5 [32.8-70.2] Gycm 2 ; P = .0023), as a consequence of a lower CADAP (16.3 [10.5-22.9] vs. 23.4","['503 consecutive patients with suspected CAD', 'population with 100% coronary artery disease (CAD', 'Mean age: 61.88 ± 11.2\xa0years, male gender 70.2', '465 cases and non-ST elevation acute coronary syndrome in 38']","['DARCA and conventional coronary angiography (CCA) techniques', 'dual-axis rotational coronary angiography (DARCA', 'DARCA', 'Dual-Axis Rotational Coronary Angiography Radiation']","['Total DAP', 'lower total E dose', 'Cine acquisition dose-area product (DAP), cumulative air kerma (AK), effective dose (E), fluoroscopic time, contrast volume, AK, cine acquisition DAP (CADAP), fluoroscopic DAP (F-DAP), and total DAP', 'Stable coronary artery disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517531', 'cui_str': '11.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0525921', 'cui_str': 'alpha,beta-diacryloxypropionic acid'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]",503.0,0.0401866,"Total DAP was also lower (40.3 [26.8-63.7] vs. 46.5 [32.8-70.2] Gycm 2 ; P = .0023), as a consequence of a lower CADAP (16.3 [10.5-22.9] vs. 23.4","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Szarfer', 'Affiliation': 'Chief Coronary Care Unit, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina. Electronic address: jorge@szarfer.com.ar.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Albornoz', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Analía', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Vielka', 'Initials': 'V', 'LastName': 'Yurko', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Blanco', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Indavere', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Gigena', 'Affiliation': 'Chief Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gagliardi', 'Affiliation': 'Chief Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Alejandro García', 'Initials': 'AG', 'LastName': 'Escudero', 'Affiliation': 'President of Board of Directors, ""Hospital El Cruce"", Buenos Aires, Argentina.'}]",Journal of medical imaging and radiation sciences,['10.1016/j.jmir.2019.12.009']
922,31972848,Health Literacy and Outcomes of a Community-Based Self-Help Intervention: A Case of Korean Americans With Type 2 Diabetes.,"BACKGROUND
Although scientific reports increasingly document the negative impact of inadequate health literacy on health-seeking behaviors, health literacy's effect on health outcomes in patients with diabetes is not entirely clear, owing to insufficient empirical studies, mixed findings, and insufficient longitudinal research.
OBJECTIVE
The aim of this study was to empirically examine underlying mechanisms of health literacy's role in diabetes management among a group of Korean Americans with Type 2 diabetes mellitus.
METHODS
Data from a randomized clinical trial of a health literacy-focused Type 2 diabetes self-management intervention conducted during 2012-2016 in the Korean American community were collected at baseline and at 3, 6, 9, and 12 months. A total of 250 Korean Americans with Type 2 diabetes participated (intervention, 120; control, 130). Participants were first-generation Korean American immigrants. Health literacy knowledge was measured with the original Rapid Estimate of Adult Literacy in Medicine and the diabetes mellitus-specific Rapid Estimate of Adult Literacy in Medicine. Functional health literacy was measured with the numeracy subscale of the Test of Functional Health Literacy in Adults and the Newest Vital Sign screening instrument, which also uses numeracy. Primary outcomes included glucose control and diabetes quality of life. Multivariate analyses included latent variable modeling.
RESULTS
A series of path analyses identified self-efficacy and self-care skills as significant mediators between health literacy and glucose control and quality of life. Education and acculturation were the most significant correlates of health literacy.
DISCUSSION
Despite inconsistent findings in the literature, this study indicates that health literacy may indirectly influence health outcomes through mediators such as self-care skills and self-efficacy. The study highlights the importance of health literacy, as well as underlying mechanisms with which health literacy influences processes and outcomes of diabetes self-management.",2020,A series of path analyses identified self-efficacy and self-care skills as significant mediators between health literacy and glucose control and quality of life.,"['Korean Americans with Type 2 Diabetes', 'patients with diabetes', '250 Korean Americans with type 2 diabetes participated (intervention, 120; control, 130', 'Korean Americans with type 2 diabetes mellitus', 'Participants were first-generation Korean American immigrants']","['health literacy-focused type 2 diabetes self-management intervention', 'Community-Based Self-Help Intervention']","['glucose control and diabetes quality of life', 'health literacy', 'Health literacy knowledge', 'Functional health literacy', 'health literacy and glucose control and quality of life']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0034380'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",250.0,0.0347658,A series of path analyses identified self-efficacy and self-care skills as significant mediators between health literacy and glucose control and quality of life.,"[{'ForeName': 'Miyong T', 'Initials': 'MT', 'LastName': 'Kim', 'Affiliation': 'Miyong T. Kim, PhD, RN, FAAN, is Professor, School of Nursing, The University of Texas at Austin. Kim B. Kim, PhD, is President, Korean Resource Center, Ellicott City, Maryland. Jisook Ko, PhD, RN, is Assistant Professor, The University of Texas Health Science Center at San Antonio. Nicole Murry, RN, PhD, is Assistant Professor, School of Nursing, The University of Texas at Austin. Bo Xie, PhD, is Professor, School of Nursing, The University of Texas at Austin. Kavita Radhakrishnan, RN, PhD, is Associate Professor, School of Nursing, The University of Texas at Austin. Hae-Ra Han, PhD, RN, FAAN, is Professor, Johns Hopkins University School of Nursing, Baltimore, Maryland.'}, {'ForeName': 'Kim B', 'Initials': 'KB', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jisook', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Murry', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Radhakrishnan', 'Affiliation': ''}, {'ForeName': 'Hae-Ra', 'Initials': 'HR', 'LastName': 'Han', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000409']
923,31968988,Effect of electroacupuncture on sedation requirements during colonoscopy: a prospective placebo-controlled randomised trial.,"INTRODUCTION
Propofol provides excellent sedation during colonoscopy. However, its application, namely when used together with an opioid, is associated with cardiopulmonary depression. Acupuncture is used nowadays for the treatment of pain and anxiety, and also to induce sedation. We hypothesised that electroacupuncture (EA) during colonoscopy would have sedative effects, thereby reducing propofol requirements to achieve an adequate level of sedation.
METHOD
The study was designed and conducted as a single centre, patient and observer blinded, sham- and placebo-controlled randomised trial. Patients scheduled for elective colonoscopy under deep propofol/alfentanil sedation were randomly assigned to receive unilateral EA, sham-acupuncture (SA) or placebo-acupuncture (PA) at ST36, PC6 and LI4. The primary outcome parameter was the total dosage of propofol. Secondary outcomes included the patients' and endoscopists' satisfaction levels evaluated by questionnaires.
RESULTS
The dosage of propofol required (median [IQR]) was not significantly different between the three groups (EA group 147 μg/kg/min [109-193] vs SA group 141 μg/kg/min [123- 180] vs PA group 141 μg/kg/min [112-182]; P=0.776). There was also no significant difference in alfentanil consumption (P=0.634). Global satisfaction (median [IQR]) among patients (EA group 6.6 [6.0-7.0] vs SA group 6.8 [6.0-7.0] vs PA group 6.5 [6.0-7.0]; P=0.481) and endoscopists (6.0 [5.0-6.0] for all groups; P=0.773) did not significantly differ between the three groups. There was no significant difference in the number of cardiorespiratory events.
CONCLUSION
For colonoscopy, the applied mode of EA did not show any propofol-sparing sedative effect compared with sham or placebo acupuncture.
TRIAL REGISTRATION
The trial is registered in the Netherland's Trial Registry (NTR4325).",2020,The dosage of propofol required (median [IQR]) was not significantly different between the three groups (EA group 147 μg/kg/min [109-193] vs SA group 141 μg/kg/min [123- 180] vs PA group 141 μg/kg/min [112-182]; P=0.776).,"['Patients scheduled for elective colonoscopy under deep propofol/alfentanil sedation', 'colonoscopy']","['For colonoscopy', 'Acupuncture', 'placebo', 'unilateral EA, sham-acupuncture (SA) or placebo-acupuncture (PA) at ST36, PC6 and LI4', 'propofol', 'electroacupuncture (EA', 'Propofol', 'electroacupuncture', 'placebo acupuncture']","['number of cardiorespiratory events', 'pain and anxiety', 'total dosage of propofol', 'Global satisfaction', 'sedation requirements', 'alfentanil consumption', ""patients' and endoscopists' satisfaction levels evaluated by questionnaires""]","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450533', 'cui_str': 'ST36 (body structure)'}, {'cui': 'C0450694', 'cui_str': 'PC6 (body structure)'}, {'cui': 'C0450480', 'cui_str': 'LI4 (body structure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.381199,The dosage of propofol required (median [IQR]) was not significantly different between the three groups (EA group 147 μg/kg/min [109-193] vs SA group 141 μg/kg/min [123- 180] vs PA group 141 μg/kg/min [112-182]; P=0.776).,"[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eberl', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Monteiro de Olivera', 'Affiliation': 'Department of Anesthesiology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Bourne', 'Affiliation': 'University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Streitberger', 'Affiliation': 'Department of Anesthesiology and Pain Therapy, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fockens', 'Affiliation': 'Department of Gastroenterology & Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Preckel', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1136/acupmed-2017-011459']
924,30944968,"Optimal non-invasive treatment of 1-2.5 cm radiolucent renal stones: oral dissolution therapy, shock wave lithotripsy or combined treatment-a randomized controlled trial.","PURPOSE
To evaluate the efficacy of oral dissolution therapy (ODT), shock wave lithotripsy (SWL), and combined SWL and ODT for medium-sized radiolucent renal stone (RLS).
METHODS
A randomized controlled trial for patients with medium-sized RLS, 1-2.5 cm, ≤ 500 Hounsfield unit (HU). The ODT patients were counseled for oral potassiumsodium-hydrogen citrate (Uralyt-U ® ). The 2nd group underwent SWL and the last group had combined SWL and ODT. The primary outcome, stone-free rate (SFR) at 3 months, was assessed by non-contrast computed tomography (NCCT). We defined complete response (success) if no residual fragment were detected by NCCT; partial response (failure) if there was a decrease in stone size, but presence of residual stones; no response if there was no change or increase in stone size (failure).
RESULTS
150 patients completed follow-up. The SFR at 1st month and 3rd month were, respectively; 16% and 50% in the ODT group, 10% and 46% in the SWL group, and 35% and 72% patients in combined group with (p = 0.03 and 0.003, respectively. The overall SFR for all groups was 66%. Combined treatment and initial response in first month follow-up were independent factors predicting SFR. In addition, combined treatment significantly decreased the overall stone volume (p = 0.03) and the need for additional stone management procedures after 3 months (p = 0.01).
CONCLUSION
Combined ODT and SWL treatment constitutes the most rapid and effective therapeutic approach for medium-sized RLS, decreasing overall stone volume as well as the number of SWL sessions needed in comparison to SWL therapy, alone.",2020,"In addition, combined treatment significantly decreased the overall stone volume (p = 0.03) and the need for additional stone management procedures after 3 months (p = 0.01).
","['1-2.5\xa0cm radiolucent renal stones', 'patients with medium-sized RLS, 1-2.5\xa0cm,\u2009≤\u2009500 Hounsfield unit (HU', '150 patients completed follow-up']","['oral dissolution therapy (ODT), shock wave lithotripsy (SWL), and combined SWL and ODT', 'dissolution therapy, shock wave lithotripsy', 'combined SWL and ODT', 'ODT and SWL']","['overall SFR', 'stone size', 'stone size (failure', 'stone-free rate (SFR', 'overall stone volume']","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0443285', 'cui_str': 'Radiolucent (qualifier value)'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.0506553,"In addition, combined treatment significantly decreased the overall stone volume (p = 0.03) and the need for additional stone management procedures after 3 months (p = 0.01).
","[{'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Elbaset', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abdelwahab', 'Initials': 'A', 'LastName': 'Hashem', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt. abdelwahab_hashem@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Eraky', 'Affiliation': 'Urology Department, Mediclin Muritz Hospital, Waren, Germany.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Badawy', 'Affiliation': 'Radiology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Assmy', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Khaled Z', 'Initials': 'KZ', 'LastName': 'Sheir', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Shokeir', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}]",World journal of urology,['10.1007/s00345-019-02746-2']
925,31696936,Global REACH 2018: The influence of acute and chronic hypoxia on cerebral haemodynamics and related functional outcomes during cold and heat stress.,"KEY POINTS
Thermal and hypoxic stress commonly coexist in environmental, occupational and clinical settings, yet how the brain tolerates these multi-stressor environments is unknown Core cooling by 1.0°C reduced cerebral blood flow (CBF) by 20-30% and cerebral oxygen delivery (CDO 2 ) by 12-19% at sea level and high altitude, whereas core heating by 1.5°C did not reliably reduce CBF or CDO 2 Oxygen content in arterial blood was fully restored with acclimatisation to 4330 m, but concurrent cold stress reduced CBF and CDO 2 Gross indices of cognition were not impaired by any combination of thermal and hypoxic stress despite large reductions in CDO 2 Chronic hypoxia renders the brain susceptible to large reductions in oxygen delivery with concurrent cold stress, which might make monitoring core temperature more important in this context ABSTRACT: Real-world settings are composed of multiple environmental stressors, yet the majority of research in environmental physiology investigates these stressors in isolation. The brain is central in both behavioural and physiological responses to threatening stimuli and, given its tight metabolic and haemodynamic requirements, is particularly susceptible to environmental stress. We measured cerebral blood flow (CBF, duplex ultrasound), cerebral oxygen delivery (CDO 2 ), oesophageal temperature, and arterial blood gases during exposure to three commonly experienced environmental stressors - heat, cold and hypoxia - in isolation, and in combination. Twelve healthy male subjects (27 ± 11 years) underwent core cooling by 1.0°C and core heating by 1.5°C in randomised order at sea level; acute hypoxia ( P ET , O 2 = 50 mm Hg) was imposed at baseline and at each thermal extreme. Core cooling and heating protocols were repeated after 16 ± 4 days residing at 4330 m to investigate any interactions with high altitude acclimatisation. Cold stress decreased CBF by 20-30% and CDO 2 by 12-19% (both P < 0.01) irrespective of altitude, whereas heating did not reliably change either CBF or CDO 2 (both P > 0.08). The increases in CBF with acute hypoxia during thermal stress were appropriate to maintain CDO 2 at normothermic, normoxic values. Reaction time was faster and slower by 6-9% with heating and cooling, respectively (both P < 0.01), but central (brain) processes were not impaired by any combination of environmental stressors. These findings highlight the powerful influence of core cooling in reducing CDO 2 . Despite these large reductions in CDO 2 with cold stress, gross indices of cognition remained stable.",2020,"•Gross indices of cognition were not impaired by any combination of thermal and hypoxic stress despite large reductions in CDO 2 •Chronic hypoxia renders the brain susceptible to large reductions in oxygen delivery with concurrent cold stress, which might make monitoring core temperature more important in this context ABSTRACT: Real-world settings are composed of multiple environmental stressors, yet the majority of research in environmental physiology investigates these stressors in isolation.",['Twelve healthy male subjects (27\xa0±\xa011 years) underwent'],['core cooling by 1.0\xa0°C and core heating by 1.5\xa0°C'],"['CBF with acute hypoxia', 'Reaction time', 'cerebral blood flow (CBF, duplex ultrasound), cerebral oxygen delivery (CDO 2 ), oesophageal temperature, and arterial blood gases during exposure to three commonly experienced environmental stressors - heat, cold and hypoxia - in isolation, and in combination', 'CBF', 'cerebral blood flow (CBF']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0242845', 'cui_str': 'Ultrasonography, Doppler, Duplex'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0220862', 'cui_str': 'isolation'}]",12.0,0.0334794,"•Gross indices of cognition were not impaired by any combination of thermal and hypoxic stress despite large reductions in CDO 2 •Chronic hypoxia renders the brain susceptible to large reductions in oxygen delivery with concurrent cold stress, which might make monitoring core temperature more important in this context ABSTRACT: Real-world settings are composed of multiple environmental stressors, yet the majority of research in environmental physiology investigates these stressors in isolation.","[{'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Gibbons', 'Affiliation': 'School of Physical Education, Sport & Exercise Science, University of Otago, 55/47 Union St W, Dunedin, 9016, New Zealand.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Tymko', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Thomas', 'Affiliation': 'Department of Surgical Sciences, University of Otago, 201 Great King St, Dunedin, 9016, New Zealand.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, University of Otago, 201 Great King St, Dunedin, 9016, New Zealand.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stembridge', 'Affiliation': 'Cardiff Centre for Exercise and Health, Cardiff Metropolitan University, Cyncoed Road, Cardiff, CF23 6XD, UK.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Caldwell', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Howe', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Hoiland', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Akerman', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, 125 University St, Ottawa, Ontario, Canada, K1N 6N5.'}, {'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Dawkins', 'Affiliation': 'Cardiff Centre for Exercise and Health, Cardiff Metropolitan University, Cyncoed Road, Cardiff, CF23 6XD, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Patrician', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Coombs', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gasho', 'Affiliation': 'Division of Pulmonary, Critical Care, Hyperbaric and Sleep Medicine, Loma Linda University School of Medicine, Loma Linda, CA, USA.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Stacey', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, UK.'}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia-Okanagan Campus, School of Health and Exercise Sciences, 3333 University Way, Kelowna, British Columbia, Canada, V1V 1V7.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Cotter', 'Affiliation': 'School of Physical Education, Sport & Exercise Science, University of Otago, 55/47 Union St W, Dunedin, 9016, New Zealand.'}]",The Journal of physiology,['10.1113/JP278917']
926,30963229,Monopolar enucleation versus transurethral resection of the prostate for small- and medium-sized (< 80 cc) benign prostate hyperplasia: a prospective analysis.,"AIM
To assess efficacy and safety of monopolar enucleation of the prostate (MEP) and to compare it with the current treatment standard for medium-sized prostates, < 80 cc, transurethral resection of the prostate (TURP).
METHODS
A prospective analysis patients undergoing a surgical procedure for their diagnosis of BPH (benign prostatic hyperplasia) (IPSS > 20, Q max < 10; prostate volume < 80 cc) was performed. IPSS, Q max were assessed preoperatively, at 6 and 12 months postoperatively. The complications were classified according to the modified Clavien-Dindo grading system.
RESULTS
A total of 134 patients were included in the study: 70 underwent MEP and 64 - TURP for BPH (mean prostate volumes were comparable with p = 0.163). The mean surgery time was 44 min in the TURP group and 48.2 min in the MEP group, (p = 0.026). Catheterization time for MEP was 1.7 and 3.2 days for TURP (p < 0.001). Hospital stay for MEP was 3.2 days vs. 4.8 days for TURP (p < 0.001). Both techniques shown comparable efficiency in benign prostatic obstruction relief with IPSS drop in MEP from 23.1 to 5.9 and in TURP group from 22.8 to 7.3, whereas Q max increased from 8.2 to 20.5 after MEP and from 8.3 and 19.9 after TURP. Urinary incontinence rate after catheter removal in TURP group was 9.0% and 7.8% in MEP group, at 1 year follow-up, it was 1.4% and 3.1% in MEP and TURP, respectively (p = 0.466).
CONCLUSIONS
Our experience demonstrated that MEP is an effective and safe BPH treatment option combining the efficacy of endoscopic enucleation techniques and accessibility of conventional TURP.",2020,Catheterization time for MEP was 1.7 and 3.2 days for TURP (p < 0.001).,"['of the prostate for small- and medium-sized (<\u200980\xa0cc) benign prostate hyperplasia', 'A total of 134 patients were included in the study: 70 underwent', 'patients undergoing a surgical procedure for their diagnosis of BPH (benign prostatic hyperplasia) (IPSS\u2009>\u200920, Q max \u2009<\u200910; prostate volume\u2009<\u200980\xa0cc) was performed']","['MEP', 'TURP', 'Monopolar enucleation versus transurethral resection', 'monopolar enucleation of the prostate (MEP', 'medium-sized prostates,\u2009<\u200980\xa0cc, transurethral resection of the prostate (TURP']","['mean surgery time', 'Catheterization time for MEP', 'Hospital stay for MEP', 'efficacy and safety', 'Q max', 'Urinary incontinence rate after catheter removal', 'IPSS, Q max']","[{'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}]",134.0,0.0191235,Catheterization time for MEP was 1.7 and 3.2 days for TURP (p < 0.001).,"[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Enikeev', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, 2/1 Bolshaya Pirogovskaya St, Moscow, 119991, Russian Federation. dvenikeev@gmail.com.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Rapoport', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, 2/1 Bolshaya Pirogovskaya St, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Magomed', 'Initials': 'M', 'LastName': 'Gazimiev', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, 2/1 Bolshaya Pirogovskaya St, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Allenov', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, 2/1 Bolshaya Pirogovskaya St, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Jasur', 'Initials': 'J', 'LastName': 'Inoyatov', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, 2/1 Bolshaya Pirogovskaya St, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Taratkin', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, 2/1 Bolshaya Pirogovskaya St, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Laukhtina', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, 2/1 Bolshaya Pirogovskaya St, Moscow, 119991, Russian Federation.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Sung', 'Affiliation': 'Department of Urology, University of California, Irvine, USA.'}, {'ForeName': 'Zhamshid', 'Initials': 'Z', 'LastName': 'Okhunov', 'Affiliation': 'Department of Urology, University of California, Irvine, USA.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Glybochko', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, 2/1 Bolshaya Pirogovskaya St, Moscow, 119991, Russian Federation.'}]",World journal of urology,['10.1007/s00345-019-02757-z']
927,29516223,A circadian rhythm-related MTNR1B genetic variant modulates the effect of weight-loss diets on changes in adiposity and body composition: the POUNDS Lost trial.,"PURPOSE
A common variant of the melatonin receptor 1B (MTNR1B) gene has been related to increased signaling of melatonin, a hormone previously associated with body fatness mainly through effects on energy metabolism. We examined whether the MTNR1B variant affects changes of body fatness and composition in response to a dietary weight loss intervention.
METHODS
The MTNR1B rs10830963 variant was genotyped for 722 overweight and obese individuals, who were randomly assigned to one of four diets varying in macronutrient composition. Anthropometric and body composition measurements (DXA scan) were collected at baseline and at 6 and 24 months of follow-up.
RESULTS
Statistically significant interactions were observed between the MTNR1B genotype and low-/high-fat diet on changes in weight, body mass index (BMI), waist circumference (WC) and total body fat (p interaction = 0.01, 0.02, 0.002 and 0.04, respectively), at 6 months of dietary intervention. In the low-fat diet group, increasing number of the sleep disruption-related G allele was significantly associated with a decrease in weight (p = 0.004), BMI (p = 0.005) and WC (p = 0.001). In the high-fat diet group, carrying the G allele was positively associated with changes in body fat (p = 0.03). At 2 years, the associations remained statistically significant for changes in body weight (p = 0.02), BMI (p = 0.02) and WC (p = 0.048) in the low-fat diet group, although the gene-diet interaction became less significant.
CONCLUSIONS
The results suggest that carriers of the G allele of the MTNR1B rs10830963 may have a greater improvement in body adiposity and fat distribution when eating a low-fat diet.",2019,"At 2 years, the associations remained statistically significant for changes in body weight (p = 0.02), BMI (p = 0.02) and WC (p = 0.048) in the low-fat diet group, although the gene-diet interaction became less significant.
",['722 overweight and obese individuals'],"['weight-loss diets', 'MTNR1B']","['BMI', 'Anthropometric and body composition measurements (DXA scan', 'weight, body mass index (BMI), waist circumference (WC) and total body fat', 'body adiposity and fat distribution', 'changes in body fat', 'number of the sleep disruption-related G allele', 'body weight', 'weight']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0012167', 'cui_str': 'Weight Reduction Diet'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1959592', 'cui_str': 'DEXA Scan'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0367088,"At 2 years, the associations remained statistically significant for changes in body weight (p = 0.02), BMI (p = 0.02) and WC (p = 0.048) in the low-fat diet group, although the gene-diet interaction became less significant.
","[{'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Goni', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, Faculty of Pharmacy and Nutrition, University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Dianjianyi', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Tiange', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Epidemiology Domain, Saw Swee Hock School of Public Health and Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, Faculty of Pharmacy and Nutrition, University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Shang', 'Affiliation': ""Children's Hospital New Orleans, New Orleans, LA, USA.""}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Smith', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, 70112, USA. lqi1@tulane.edu.'}]",European journal of nutrition,['10.1007/s00394-018-1660-y']
928,31983494,Oral Ondansetron to Reduce Vomiting in Children Receiving Intranasal Fentanyl and Inhaled Nitrous Oxide for Procedural Sedation and Analgesia: A Randomized Controlled Trial.,"STUDY OBJECTIVE
Intranasal fentanyl and inhaled nitrous oxide are increasingly combined to provide procedural sedation and analgesia in the pediatric emergency setting. This regimen is attractive because of its nonparenteral administration, but is associated with a higher incidence of vomiting than nitrous oxide alone. We seek to assess whether prophylactic oral ondansetron use could reduce the incidence of vomiting associated with intranasal fentanyl and nitrous oxide for procedural sedation compared with placebo.
METHODS
This was a double-blind, randomized controlled trial of oral ondansetron versus placebo conducted at a single tertiary care pediatric emergency department. Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide were randomized to receive oral ondansetron or placebo 30 to 60 minutes before nitrous oxide administration. The primary outcome was early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration. Secondary outcomes included vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups.
RESULTS
We recruited 442 participants and 436 were included for analysis. There was no significant difference in the primary outcome, early vomiting associated with procedural sedation, between the groups: ondansetron 12% versus placebo 16%, with a difference in proportions of -4.6% (95% confidence interval -11% to 2.0%; P=.18). Most sedations were reported as optimal by treating clinicians (91%). Only 2 minor adverse events occurred, both in the placebo group.
CONCLUSION
Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.",2020,Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.,"['442 participants and 436 were included for analysis', 'Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide', 'single tertiary care pediatric emergency department', 'Children Receiving Intranasal Fentanyl and Inhaled Nitrous Oxide for Procedural Sedation and Analgesia']","['fentanyl and inhaled nitrous oxide', 'oral ondansetron or placebo', 'ondansetron', 'Oral ondansetron', 'placebo', 'oral ondansetron', 'Oral Ondansetron', 'inhaled nitrous oxide']","['Vomiting', 'incidence of vomiting', 'vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups', 'early vomiting associated with procedural sedation', 'vomiting', 'adverse events', 'early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",442.0,0.574584,Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.,"[{'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Fauteux-Lamarre', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'Quinn', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia; Melbourne Children's Trials Centre, Melbourne, Victoria, Australia.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Legge', 'Affiliation': ""Department of Pharmacy, The Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia; Melbourne Children's Trials Centre, Melbourne, Victoria, Australia.""}, {'ForeName': 'Greta M', 'Initials': 'GM', 'LastName': 'Palmer', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia. Electronic address: franz.babl@rch.org.au.""}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Hopper', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.""}]",Annals of emergency medicine,['10.1016/j.annemergmed.2019.11.019']
929,31973959,Video Glasses Reduce Preoperative Anxiety Compared With Portable Multimedia Player in Children: A Randomized Controlled Trial.,"PURPOSE
Preoperative anxiety in children is challenging for anesthesia providers and nurses. The use of video glasses (VG), an immersive head mount display, helps conceal the unfamiliar operating room environment from the patient's visual field. The aim of this study was to determine the anxiolytic effect of VG compared with that of a portable multimedia player (PMP) during the preoperative period in children.
DESIGN
Prospective randomized trial.
METHODS
Participants were randomized into VG or PMP groups. Patients watched their favorite animation videos using the allocated device from the time of entering the preanesthetic holding area to the end of anesthetic induction. We evaluated modified Yale Preoperative Anxiety Scale scores during anesthetic induction.
FINDINGS
The modified Yale Preoperative Anxiety Scale score in the VG group was significantly lower than that in the PMP group (P = .001).
CONCLUSIONS
In children, the anxiolytic effect of VG during the preoperative period is larger than that of PMP.",2020,"The modified Yale Preoperative Anxiety Scale score in the VG group was significantly lower than that in the PMP group (P = .001).
","['children', 'Participants were randomized into VG or PMP groups', 'Children']","['PMP', 'Portable Multimedia Player', 'portable multimedia player (PMP', 'video glasses (VG']","['Preoperative Anxiety', 'modified Yale Preoperative Anxiety Scale scores', 'anxiolytic effect of VG', 'modified Yale Preoperative Anxiety Scale score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0017596', 'cui_str': 'Glass'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3179404', 'cui_str': 'Antianxiety Effects'}]",,0.0478107,"The modified Yale Preoperative Anxiety Scale score in the VG group was significantly lower than that in the PMP group (P = .001).
","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Chaki', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan. Electronic address: chakitomohiro0728@yahoo.co.jp.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Hirata', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tokinaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.10.001']
930,31683483,Effect of Chlorogenic Acids on Cognitive Function in Mild Cognitive Impairment: A Randomized Controlled Crossover Trial.,"BACKGROUND
Mild cognitive impairment (MCI) is a global-scale issue, due in large part to the rapidly growing elderly population. The main polyphenol contained in coffee beans, chlorogenic acid (CGA), improves attention in healthy individuals. The utility of CGAs for treating MCI, however, has not been evaluated.
OBJECTIVE
To determine the effects of continuous CGA intake on cognitive function, especially attention, in patients diagnosed with MCI.
METHODS
The study was a randomized controlled crossover trial including 34 patients with MCI. Participants were randomly divided into two groups: Those who first ingested a placebo beverage and those who first ingested an active beverage containing CGAs (553.6 mg/bottle) twice daily for 12 weeks. After a 4-week washout period, the subjects ingested the other beverage (i.e., placebo or active beverage) in the same manner. Endpoint measures included scores on the Japanese version of the Mini-Mental State Examination (MMSE), the Japanese version of the Alzheimer's Disease Assessment Scale-cognitive component (ADAS-cog) testing overall cognitive function, and the Japanese version of the Trail Making Test (TMT-A, TMT-B) testing attention, along with the results of blood tests to evaluate safety.
RESULTS
In the TMT-B test, participants had a significantly reduced number of errors while ingesting the CGA beverage as compared with the placebo beverage (p < 0.05), although there was no difference in test completion time. Scores in the MMSE, ADAS-cog, and TMT-A did not differ significantly between conditions.
CONCLUSION
Continuous intake of CGAs appears to improve attention and executive function among cognitive functions in MCI.",2019,"In the TMT-B test, participants had a significantly reduced number of errors while ingesting the CGA beverage as compared with the placebo beverage (p < 0.05), although there was no difference in test completion time.","['healthy individuals', '34 patients with MCI', 'Mild Cognitive Impairment', 'patients diagnosed with MCI']","['continuous CGA intake', 'CGAs', 'Chlorogenic Acids', 'placebo or active beverage', 'polyphenol contained in coffee beans, chlorogenic acid (CGA', 'placebo beverage and those who first ingested an active beverage containing CGAs']","[""scores on the Japanese version of the Mini-Mental State Examination (MMSE), the Japanese version of the Alzheimer's Disease Assessment Scale-cognitive component (ADAS-cog) testing overall cognitive function, and the Japanese version of the Trail Making Test (TMT-A, TMT-B) testing attention, along with the results of blood tests to evaluate safety"", 'Cognitive Function']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C4518417', 'cui_str': 'Contained in (attribute)'}, {'cui': 'C1440480', 'cui_str': 'Coffee bean'}, {'cui': 'C0008240', 'cui_str': 'Chlorogenic acid'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.104143,"In the TMT-B test, participants had a significantly reduced number of errors while ingesting the CGA beverage as compared with the placebo beverage (p < 0.05), although there was no difference in test completion time.","[{'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Ochiai', 'Affiliation': 'Biological Science Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Saitou', 'Affiliation': 'Health Care Food Research Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Suzukamo', 'Affiliation': 'Biological Science Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Osaki', 'Affiliation': 'Health Care Food Research Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Asada', 'Affiliation': 'Faculty of Medicine, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190757']
931,31964579,"Effects of an educational intervention on heart failure knowledge, self-care behaviors, and health-related quality of life of patients with heart failure: Exploring the role of depression.","OBJECTIVES
To test effects of an educational intervention on patient-reported outcomes among rural heart failure (HF) patients and to examine whether effects differed between patients with and without depression.
METHODS
Patients (N = 614) were randomized to usual care (UC) or 1 of 2 intervention groups. Both intervention groups received face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS). Follow-up lasted 24 months. Statistical analyses included linear mixed models and subgroup analyses by depression status.
RESULTS
Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001). Improvement lasted 24 months only in the PLUS group. Compared to UC, both intervention groups exhibited better self-care at 3 months (LITE-UC, p < 0.001; PLUS-UC, p < 0.001) and 12 months (LITE-UC, p = 0.001; PLUS-UC, p = 0.002). There were no differences in health-related quality of life (HRQOL) among groups. In subgroup analyses, similar effects were found among non-depressed, but not among depressed patients.
CONCLUSION
The educational intervention improved HF knowledge and self-care, but not HRQOL. No intervention effects were observed in patients with depressive symptoms.
PRACTICE IMPLICATIONS
The simple educational intervention is promising to improve HF knowledge and self-care. Additional strategies are needed for depressed patients.",2020,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","['Patients (N\u202f=\u202f614', 'rural heart failure (HF) patients', 'patients with depressive symptoms', 'patients with and without depression', 'patients with heart failure']","['face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS', 'usual care (UC', 'educational intervention']","['HF knowledge', 'HF knowledge and self-care', 'health-related quality of life (HRQOL', 'heart failure knowledge, self-care behaviors, and health-related quality of life', 'self-care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",614.0,0.0257365,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","[{'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Hwang', 'Affiliation': 'College of Nursing & Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea. Electronic address: bhwang@snu.ac.kr.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Pelter', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Moser', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dracup', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.007']
932,31965072,"Liraglutide improves memory in obese patients with prediabetes or early type 2 diabetes: a randomized, controlled study.","BACKGROUND/OBJECTIVES
Diabetic subjects are at increased risk of subtle cognitive impairment since the disease early stages and of dementia later in life. In animal models, glucagon-like peptide-1 receptor agonizts (GLP1-RAs) have been shown to exert neuroprotective effects, expecially in the memory domain. We assessed whether treatment with a GLP1-RA might affect cognitive functions in type 2 diabetic subjects independently on the weight loss it might induce.
SUBJECTS/METHODS
Forty metformin-treated obese subjects with prediabetes or newly diagnosed type 2 diabetes mellitus, received liraglutide (1.8 mg/d) (n = 20) or lifestyle counseling (dietary intervention and exercise training) (n = 20) until achieving a modest and comparable weight loss (-7% of initial body weight).
INTERVENTIONS/METHODS
A detailed neuropsychological assessment before and after weight loss was completed in 16 patients per arm, who were administered a total of seven psychological tests, thus assessing three composite domain z-scores for attention, memory, and executive control.
RESULTS
After comparable weight loss and superimposable glycemic control and insulin sensitivity, a significant increase in short term memory (mean Digit Span Z score from -0.06 to 0.80, p = 0.024) and memory composite z-score (mean memory z-score from -0.67 to 0.032, p = 0.0065) was observed in the liraglutide exposed subjects (between group p = 0.041 and p = 0.033, respectively).
CONCLUSIONS
Liraglutide might slow down memory function decline in diabetic patients in early, and possibly preclinical stages of the disease.",2020,"Liraglutide might slow down memory function decline in diabetic patients in early, and possibly preclinical stages of the disease.","['obese patients with prediabetes or early type 2 diabetes', 'type 2 diabetic subjects', 'Forty metformin-treated obese subjects with prediabetes or newly diagnosed type 2 diabetes mellitus', 'diabetic patients', 'Diabetic subjects']","['lifestyle counseling (dietary intervention and exercise training', 'liraglutide', 'Liraglutide', 'GLP1-RA']","['weight loss and superimposable glycemic control and insulin sensitivity', 'weight loss', 'cognitive functions', 'short term memory (mean Digit Span Z score', 'memory composite z-score']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",,0.0226642,"Liraglutide might slow down memory function decline in diabetic patients in early, and possibly preclinical stages of the disease.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vadini', 'Affiliation': 'Psychoinfectivology Service, Pescara General Hospital, Pescara, Italy.'}, {'ForeName': 'Paola G', 'Initials': 'PG', 'LastName': 'Simeone', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Boccatonda', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Guagnano', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Liani', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Tripaldi', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Di Castelnuovo', 'Affiliation': 'Mediterranea, Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cipollone', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Santilli', 'Affiliation': 'Department of Medicine and Aging, Center of Aging Science and Translational Medicine (CESI-Met), Via Luigi Polacchi, Chieti, Italy. francesca.santilli@unich.it.'}]",International journal of obesity (2005),['10.1038/s41366-020-0535-5']
933,31952657,Is intraperitoneal chemotherapy still an acceptable option in primary adjuvant chemotherapy for advanced ovarian cancer?,"The role of intraperitoneal (i.p.) chemotherapy in treating newly diagnosed advanced epithelial ovarian cancer (EOC) has been the subject of controversy for almost three decades. Three large intergroup phase III trials (GOG 104, 114, 172) have demonstrated a survival benefit associated with i.p. over intravenous (i.v.) therapy in advanced, low-volume EOC. Despite the positive clinical trial results and a subsequent National Cancer Institute alert in 2006, i.p. treatment has not been widely accepted as the standard of care in the United States and is infrequently used in Europe. The hesitancy of clinicians to use i.p. therapy is likely attributed to higher toxicity, inconvenience, catheter complications, and clinical trial design issues. On the other hand, In a long-term follow-up report from these trials, we showed that the effect of i.p. chemotherapy extends beyond 10 years and that the more cycles of i.p. therapy portends for improved survival over similar cycles of i.v. therapy with younger patients having a higher likelihood of completing 6 cycles of i.p. treatment. More recently, a fourth randomized phase III trial, GOG 252, failed to show a survival advantage associated with i.p. cisplatin and i.p. carboplatin over dose-dense i.v. paclitaxel and carboplatin. Since the use of bevacizumab was incorporated in all arms of the study, this anti-vascular agent may have equalized or negated the clinical advantage of i.p. chemotherapy and dose-dense weekly as suggested in GOG 262. We are awaiting the results of the Asian iPocc trial comparing dose-dense paclitaxel to i.p. chemotherapy without bevacizumab, though the differences in the tumor histology and pharmacokinetics in Asian versus non-Asian patients may influence the interpretation of the results worldwide. In this review, we review the polarizing opinions on the relevance of i.p. therapy in today's clinical armamentarium. Never before, have oncologists examined the same datasets with divergent conclusions. This topic is confusing to patients and clinicians alike and has led to inconsistent guidelines and reimbursement. However, it might be time to move on. Now more than ever, we have novel combinations to personalize upfront treatments for advanced ovarian cancer. In addition to i.p. therapy we also need to focus on targeted therapy, biomarkers, survivorship, and the sequencing of therapy.",2017,"Three large intergroup phase III trials (GOG 104, 114, 172) have demonstrated a survival benefit associated with i.p.","['newly diagnosed advanced epithelial ovarian cancer (EOC', 'advanced ovarian cancer', 'Asian versus non-Asian patients']","['cisplatin', 'intraperitoneal (i.p.) chemotherapy', 'paclitaxel and carboplatin', 'chemotherapy without bevacizumab', 'carboplatin', 'bevacizumab', 'chemotherapy']","['survival', 'survival benefit']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0705379,"Three large intergroup phase III trials (GOG 104, 114, 172) have demonstrated a survival benefit associated with i.p.","[{'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph's Hospital, Phoenix;. Electronic address: bradley.monk@usoncology.com.""}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Chan', 'Affiliation': 'Division of Gynecologic Oncology, Palo Alto Medical Foundation, California Pacific Medical Center, Sutter Health Research Institute, San Francisco, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx451']
934,31461581,"Manuka honey sinus irrigations in recalcitrant chronic rhinosinusitis: phase 1 randomized, single-blinded, placebo-controlled trial.","BACKGROUND
Manuka honey (MH) has significant antibiofilm activity in vitro and in vivo against Staphylococcus aureus, methicillin-resistant S aureus (MRSA), and Pseudomonas aeruginosa. This is the first randomized, single-blinded, placebo-controlled phase 1 clinical trial investigating the safety and preliminary efficacy of MH with augmented methylglyoxal (MGO) rinses in recalcitrant chronic rhinosinusitis (CRS).
METHODS
Patients were included after previously undergoing endoscopic sinus surgery and presenting with signs and symptoms of sinus infection with positive bacterial cultures on sinus swabs. Patients were randomized to receive 14 days of twice-daily 16.5% MH + 1.3 mg/mL MGO sinonasal rinses and concurrent 10 days of placebo tablets (MH), or 14 days of twice-daily saline sinonasal rinses and concurrent 10 days of culture-directed antibiotic therapy (CON). Safety observations included the University of Pennsylvania Smell Identification Test (UPSIT) and adverse-event (AE) reporting. Efficacy was assessed comparing microbiology results, Lund-Kennedy scores (LKSs), and symptom scores using the visual analog scale (VAS) and 22-item Sino-Nasal Outcome Test (SNOT-22).
RESULTS
Twenty-five patients completed the study. MH demonstrated a good safety profile with no major AEs and no changes in UPSIT. Six of 10 (60%) MH patients had a reduction in bacterial culture rate with 1 of 10 of those having negative cultures, compared with 12 of 15 (80%) in the control group with 7 of 15 having negative cultures upon completion of the study.
CONCLUSION
This study concludes that twice-daily 16.5% MH augmented with 1.3 mg/mL MGO sinonasal rinses alone for 14 days is safe but not superior to culture-directed oral antibiotics and twice-daily saline rinses.",2019,"Six of 10 (60%) MH patients had a reduction in bacterial culture rate with 1 of 10 of those having negative cultures, compared with 12 of 15 (80%) in the control group with 7 of 15 having negative cultures upon completion of the study.
","['Twenty-five patients completed the study', 'recalcitrant chronic rhinosinusitis (CRS', 'recalcitrant chronic rhinosinusitis', 'Patients were included after previously undergoing endoscopic sinus surgery and presenting with signs and symptoms of sinus infection with positive bacterial cultures on sinus swabs']","['placebo', 'Manuka honey (MH', 'Manuka honey sinus irrigations', 'twice-daily 16.5% MH + 1.3 mg/mL MGO sinonasal rinses and concurrent 10 days of placebo tablets (MH), or 14 days of twice-daily saline sinonasal rinses and concurrent 10 days of culture-directed antibiotic therapy (CON', 'MH with augmented methylglyoxal (MGO) rinses']","['bacterial culture rate', 'microbiology results, Lund-Kennedy scores (LKSs), and symptom scores using the visual analog scale (VAS) and 22-item Sino-Nasal Outcome Test (SNOT-22', 'University of Pennsylvania Smell Identification Test (UPSIT) and adverse-event (AE) reporting']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0037199', 'cui_str': 'Sinus Infections'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture (procedure)'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0034338', 'cui_str': 'Pyruvaldehyde'}]","[{'cui': 'C0430402', 'cui_str': 'Bacterial culture (procedure)'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure (procedure)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.202011,"Six of 10 (60%) MH patients had a reduction in bacterial culture rate with 1 of 10 of those having negative cultures, compared with 12 of 15 (80%) in the control group with 7 of 15 having negative cultures upon completion of the study.
","[{'ForeName': 'Mian Li', 'Initials': 'ML', 'LastName': 'Ooi', 'Affiliation': 'Department of Surgery-Otolaryngology, Head and Neck Surgery, Basil Hetzel Institute for Translational Health Research, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Jothin', 'Affiliation': 'Department of Surgery-Otolaryngology, Head and Neck Surgery, Basil Hetzel Institute for Translational Health Research, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bennett', 'Affiliation': 'Department of Surgery-Otolaryngology, Head and Neck Surgery, Basil Hetzel Institute for Translational Health Research, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Eng H', 'Initials': 'EH', 'LastName': 'Ooi', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Flinders Medical Centre and Flinders University, Bedford Park, Adelaide, SA, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vreugde', 'Affiliation': 'Department of Surgery-Otolaryngology, Head and Neck Surgery, Basil Hetzel Institute for Translational Health Research, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Alkis J', 'Initials': 'AJ', 'LastName': 'Psaltis', 'Affiliation': 'Department of Surgery-Otolaryngology, Head and Neck Surgery, Basil Hetzel Institute for Translational Health Research, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Peter-John', 'Initials': 'PJ', 'LastName': 'Wormald', 'Affiliation': 'Department of Surgery-Otolaryngology, Head and Neck Surgery, Basil Hetzel Institute for Translational Health Research, The University of Adelaide, Adelaide, SA, Australia.'}]",International forum of allergy & rhinology,['10.1002/alr.22423']
935,31932084,Efficacy and Safety of Alirocumab in Patients With Autosomal Dominant Hypercholesterolemia Associated With Proprotein Convertase Subtilisin/Kexin Type 9 Gain-of-Function or Apolipoprotein B Loss-of-Function Mutations.,"Autosomal dominant hypercholesterolemia results from mutations affecting the low-density lipoprotein receptor pathway, including proprotein convertase subtilisin/kexin type 9 (PCSK9) gain-of-function mutations (GoFm) and apolipoprotein B (APOB) loss-of-function mutations (LoFm). This study examined the long-term efficacy and safety of alirocumab in patients with PCSK9 GoFm and APOB LoFm who participated in the open-label extension to a Phase 2 double-blind study (NCT01604824). Of the 23 patients who completed the 14-week double-blind period and 8-week follow-up, 21 opted to continue in the open-label extension (PCSK9 GoFm, n = 15; APOB LoFm, n = 6). Patients received alirocumab 150 mg every 2 weeks from week 32 up to 3 years for PCSK9 GoFm and 2 years for APOB LoFm. Mean duration of alirocumab exposure was 129 weeks (median: 144 weeks). After initiation of alirocumab treatment, low-density lipoprotein cholesterol (LDL-C) decreased in both groups. At week 80, mean percent reduction in LDL-C from baseline was 58.0% and 47.1% for PCSK9 GoFm and APOB LoFm groups, respectively. Treatment-emergent adverse events were reported in 19 patients (90.5%); no patients discontinued treatment due to treatment-emergent adverse events. In patients with autosomal dominant hypercholesterolemia and elevated LDL-C levels despite receiving maximally tolerated lipid-lowering therapies, alirocumab 150 mg every 2 weeks resulted in clinically meaningful reductions in LDL-C, sustained through to 3 years and 2 years for patients with PCSK9 GoFm and APOB LoFm, respectively. Alirocumab was generally well tolerated with no unexpected safety concerns.",2020,"At week 80, mean percent reduction in LDL-C from baseline was 58.0% and 47.1% for PCSK9 GoFm and APOB LoFm groups, respectively.","['patients with autosomal dominant hypercholesterolemia and elevated LDL-C levels', 'patients with PCSK9 GoFm and APOB LoFm who participated in the open-label extension to a Phase 2 double-blind study (NCT01604824', 'Patients With Autosomal Dominant Hypercholesterolemia Associated With Proprotein Convertase Subtilisin/Kexin Type 9', '23 patients']","['alirocumab', 'Alirocumab', 'Apolipoprotein B']","['low-density lipoprotein cholesterol (LDL-C', 'LDL-C', 'Mean duration of alirocumab exposure', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0745103', 'cui_str': 'LDL Receptor Disorder'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0013072', 'cui_str': 'Double-Masked Method'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertases'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'kexin protein, S cerevisiae'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0458937,"At week 80, mean percent reduction in LDL-C from baseline was 58.0% and 47.1% for PCSK9 GoFm and APOB LoFm groups, respectively.","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Krempf', 'Affiliation': 'Clinique Bretéché, Nantes, France. Electronic address: michel.krempf@univ-nantes.fr.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Hopkins', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bruckert', 'Affiliation': 'Hôpital de la Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Donahue', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New Jersey.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.12.028']
936,31926951,Early gestational diabetes screening in obese women: a randomized controlled trial.,"BACKGROUND
Although in 2013 the American College of Obstetricians and Gynecologists recommended early screening for gestational diabetes in obese women, no studies demonstrate an improvement in perinatal outcomes with this strategy.
OBJECTIVE
We sought to determine whether early screening for gestational diabetes improves perinatal outcomes in obese women.
MATERIALS AND METHODS
Randomized controlled trial comparing early gestational diabetes screening (14-20 weeks) to routine screening (24-28 weeks) in obese women (body mass index ≥30 kg/m 2 ) at 2 tertiary care centers in the United States. Screening was performed using a 50-g, 1-hour glucose challenge test followed by a 100-g, 3-hour glucose tolerance test if the initial screen was ≥135 mg/dL. Gestational diabetes was diagnosed using Carpenter-Coustan criteria. Women not diagnosed at 14 to 20 weeks were rescreened at 24 to 28 weeks. Exclusion criteria were pre-existing diabetes, major medical illness, bariatric surgery, and prior cesarean delivery. The primary outcome was a composite of macrosomia (>4000 g), primary cesarean delivery, hypertensive disease of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia (assessed within 48 hours of birth).
RESULTS
A total of 962 women were randomized, and outcomes were available for 922. Of these 922 women, 459 (49.8%) were assigned to early screen and 463 (50.2%) to routine screen. Baseline characteristics were balanced between groups. In the early screening group, 69 (15.0%; 95% confidence interval, 11.9-18.6%) were diagnosed with gestational diabetes: 29 (6.3%; 95% confidence interval, 4.3-8.9%) at <20 weeks and 40 (8.7%; 95% confidence interval, 6.3-11.7%) at >24 weeks. Of those randomized to routine screening, 56 (12.1%; 95% confidence interval, 9.3-15.4%) had gestational diabetes. Early screening did not reduce the incidence of the primary outcome (56.9% in the early screen versus 50.8% in the routine screen, P = .07; relative risk, 1.12; 95% confidence interval, 0.99-1.26).
CONCLUSION
Early screening for gestational diabetes in obese women did not reduce the composite perinatal outcome.",2020,"Early screening did not reduce the incidence of the primary outcome (56.9% in early screen vs 50.8% in routine screen, p=0.07, RR 1.12, 95% CI 0.99-1.26).
","['early gestational diabetes screening (14-20 weeks) to routine screening (24-28 weeks) in obese women (BMI≥30 kg/m 2 ) at two tertiary care centers in the US', 'A total of 962 women', 'Early Gestational Diabetes Screening in Obese Women', 'obese women', 'gestational diabetes in obese women']",[],"['diagnosed with gestational diabetes', 'composite of macrosomia (>4000g), primary cesarean, hypertensive disease of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia (assessed within 48 hours of birth', 'gestational diabetes']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",[],"[{'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0269825', 'cui_str': 'Shoulder girdle dystocia (disorder)'}, {'cui': 'C0857007', 'cui_str': 'Hyperbilirubinemia, Neonatal'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia (disorder)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",962.0,0.519412,"Early screening did not reduce the incidence of the primary outcome (56.9% in early screen vs 50.8% in routine screen, p=0.07, RR 1.12, 95% CI 0.99-1.26).
","[{'ForeName': 'Lorie M', 'Initials': 'LM', 'LastName': 'Harper', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL. Electronic address: lmharper@uabmc.edu.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Jauk', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL.""}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': ""Women's Services Center of Excellence, Ochsner Health System, New Orleans, LA.""}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Biggio', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL; Women's Services Center of Excellence, Ochsner Health System, New Orleans, LA.""}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL.""}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Tita', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.021']
937,31923161,A Randomized Controlled Trial Comparing Short-term Outcomes of Self-Gripping (Progrip) Mesh Versus Fibrin Sealant in Laparoscopic Total Extraperitoneal Hernioplasty.,"BACKGROUND
There are no data comparing the use of self-gripping mesh with standard mesh in total extraperitoneal repair (TEP). In this prospective study we aim to study the incidence of chronic pain between Progrip (PG) and standard mesh fixed by fibrin sealant (FS).
MATERIALS AND METHODS
Under Institutional Review Board approval, from April 2016 to May 2017, patients with primary unilateral or bilateral inguinal hernia eligible for TEP were recruited. Before mesh insertion they were randomized into PG or FS (Tisseel). Demographics, intraoperative, and postoperative data were recorded. Patients were followed up for at least 1 year. Visual Analog Scale was used to record pain scores. Primary outcome was the incidence of chronic pain at 3 months after surgery.
RESULTS
One hundred fifty patients were randomized. Of the 150 patients (193 hernias), 76 were randomized to PG and 74 randomized to FS. Demographic data such as age, presence of comorbidities, smoking history, mean body mass index was comparable in both groups. Bilateral hernias occurred in 25 (32.9%) and 18 (24.3%) patients in PG and FS group, respectively. Mean mesh deployment time was 283.7 seconds (range, 140 to 720 s) in PG group and 301.9 seconds (range, 67 to 1006 s) in FS group (P=0.30). A total of 5 patients were lost at follow-up and they were excluded from subsequent data analysis. Seroma occurred in 15 (20.3%) and 16 (22.5%) patients in PG and FS group, respectively (P=0.45). Mean Visual Analog Scale at 2 weeks (cough) was highest at 1.05 and 1.02 in PG and FS group, respectively (P=0.62). Eight (12.3%) and 15 (23.4%) patients in PG and FG group, respectively, reported pain at 3-month follow-up (P=0.1). Of those who experienced pain, majority was mild pain which did not affect activities of daily living. At a mean follow-up of 13.1±5.4 months, no recurrence was detected.
CONCLUSIONS
There was no significant difference in terms of chronic pain between PG and FS group. The use of PG is effective in TEP.",2020,"Mean mesh deployment time was 283.7 seconds (range, 140 to 720 s) in PG group and 301.9 seconds (range, 67 to 1006 s) in FS group (P=0.30).","['One hundred fifty patients were randomized', '150 patients (193 hernias', 'patients with primary unilateral or bilateral inguinal hernia eligible for TEP were recruited', 'Laparoscopic Total Extraperitoneal Hernioplasty']","['Progrip (PG) and standard mesh fixed by fibrin sealant (FS', 'FS', 'self-gripping mesh with standard mesh in total extraperitoneal repair (TEP', 'Self-Gripping (Progrip) Mesh Versus Fibrin Sealant']","['Mean Visual Analog Scale', 'Seroma', 'Bilateral hernias', 'incidence of chronic pain', 'Demographics, intraoperative, and postoperative data', 'chronic pain', 'pain', 'Mean mesh deployment time', 'Visual Analog Scale']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0267672', 'cui_str': 'Bilateral inguinal hernia (disorder)'}, {'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",150.0,0.176226,"Mean mesh deployment time was 283.7 seconds (range, 140 to 720 s) in PG group and 301.9 seconds (range, 67 to 1006 s) in FS group (P=0.30).","[{'ForeName': 'Tsz Ting', 'Initials': 'TT', 'LastName': 'Law', 'Affiliation': 'Department of Surgery, Tung Wah Hospital, Sheung Wan.'}, {'ForeName': 'Ka Kin', 'Initials': 'KK', 'LastName': 'Ng', 'Affiliation': 'Department of Surgery, Tung Wah Hospital, Sheung Wan.'}, {'ForeName': 'Rockson', 'Initials': 'R', 'LastName': 'Wei', 'Affiliation': 'Department of Surgery, Queen Mary Hospital, the University of Hong Kong, Pok Fu Lam, Hong Kong SAR, China.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Yip', 'Affiliation': 'Department of Surgery, Queen Mary Hospital, the University of Hong Kong, Pok Fu Lam, Hong Kong SAR, China.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Ng', 'Affiliation': 'Department of Surgery, Tung Wah Hospital, Sheung Wan.'}, {'ForeName': 'Kin Yuen', 'Initials': 'KY', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, Tung Wah Hospital, Sheung Wan.'}, {'ForeName': 'Chi Chung', 'Initials': 'CC', 'LastName': 'Foo', 'Affiliation': 'Department of Surgery, Queen Mary Hospital, the University of Hong Kong, Pok Fu Lam, Hong Kong SAR, China.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000756']
938,31860326,Sex-Specific Differential Responses of Circulating Biomarkers in Obstructive Sleep Apnea Treatment. A Post Hoc Analysis of a Randomized Controlled Trial.,"Rationale : Knowledge of sex-specific changes of cardiovascular biomarkers in response to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) is limited. Objectives : We hypothesized a differential sex-specific cardiovascular biomarker response with CPAP therapy for OSA. Methods : Participants with moderate-severe OSA (apnea-hypopnea index, 15 events/h) were randomized to CPAP versus sham and completed polysomnography and collection of biomarkers of inflammation (myeloperoxidase, fibrinogen, paraoxonase, interleukin [IL]-6, IL-6 soluble receptor, aryl esterase, oxidized low-density lipoprotein, lipoprotein A, plasminogen activator inhibitor 1, and F 2 -isoprostane urine/creatinine ratio) and vascular measures at baseline and 8 weeks of therapy with either CPAP ( n = 72) or sham treatment ( n = 70). Post hoc secondary analyses of sex-study arm interaction relative to change in inflammatory biomarkers were evaluated via linear regression with adjustment for baseline biomarker value, age, race, body mass, index, waist circumference, and CPAP adherence. Interactions were further evaluated via sex-stratified analyses. Results : The study sample comprised a total of 149 participants aged 50.8 ± 11.7 years; 55% were male, and 55% were white. Participants had a median apnea-hypopnea index of 26.3 events per hour (interquartile range, 13-37). There were substantial interactions between study arm and sex for myeloperoxidase, paraoxonase, and fibrinogen ( P = 0.03, P = 0.03, and P = 0.08, respectively). No significant interactions were found for the vascular measures. Estimates were similar but with decreased power in sex-stratified analyses, with decreased biomarkers in women and increased biomarkers in men. Conclusions : Differential sex-specific responses to CPAP therapy for OSA were observed for circulating inflammatory biomarkers, which persisted after adjustment for confounders. These findings set the stage for validation studies and, if confirmed, biochemical pathway elucidation to inform sex-specific personalized treatment approaches.Clinical trial registered with www.clinicaltrials.gov (NCT00607893).",2020,"CONCLUSIONS
Differential sex-specific responses to CPAP therapy for OSA were observed for circulating inflammatory biomarkers which persisted after adjustment for confounders.","['Participants with moderate-severe OSA(apnea-hypopnea index, AHI ≥ 15', '149 participants were aged 50.8±11.7 years, 55% male, 55% white with median AHI 26.3 (IQR:13-37', 'Obstructive Sleep Apnea Treatment', 'obstructive sleep apnea (OSA']","['continuous positive airway pressure (CPAP) therapy', 'CPAP', 'CPAP therapy']","['inflammation (myeloperoxidase, fibrinogen, paroxonase, interleukin(IL)-6, IL-6 soluble receptor, aryl esterase, oxidized LDL, lipoprotein A, plasminogen activator inhibitor-1, and F2-isoprostane urine to creatinine ratio) and vascular measures']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517668', 'cui_str': 'Twenty-six point three'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0014894', 'cui_str': 'Esterases'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein Lp(a)'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0949861', 'cui_str': 'F2-Isoprostanes'}, {'cui': 'C0042037'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0429854', 'cui_str': 'Vascular measure'}]",149.0,0.126066,"CONCLUSIONS
Differential sex-specific responses to CPAP therapy for OSA were observed for circulating inflammatory biomarkers which persisted after adjustment for confounders.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, VA Northeast Ohio Healthcare System, Cleveland, Ohio; and.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute.'}, {'ForeName': 'Kingman P', 'Initials': 'KP', 'LastName': 'Strohl', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, VA Northeast Ohio Healthcare System, Cleveland, Ohio; and.'}, {'ForeName': 'Harneet', 'Initials': 'H', 'LastName': 'Walia', 'Affiliation': 'Sleep Disorders Center, Neurologic Institute, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University.'}, {'ForeName': 'Stan L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, and.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Sleep Disorders Center, Neurologic Institute, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201908-593OC']
939,31571295,Trans-tract electrocoagulation can decrease the need for postoperative nephrostomy tube after endoscopic combined intrarenal surgery.,"AIM
To assess the efficacy and safety of trans-tract electrocoagulation at the end of endoscopic combined intrarenal surgery for renal or ureteral stones.
METHODS
The present study included patients who underwent endoscopic combined intrarenal surgery from May 2010 to March 2018. After June 2013, the trans-tract electrocoagulation procedure, to coagulate bleeding from the access tract using a resectscope was carried out at the end of the operation. We compared the patients' background and surgical outcomes between patients with and without trans-tract electrocoagulation.
RESULTS
Between the trans-tract electrocoagulation (n = 225) and non-trans-tract electrocoagulation (n = 72) groups, the stone number was significantly smaller (1:2:3 or more, 126:72:27 vs 59:10:3, P = 0.001) and the initial stone-free rates were significantly higher (80% vs 72%, P = 0.006) in the trans-tract electrocoagulation group than in the non-trans-tract electrocoagulation group. Patients experienced a higher nephrostomy tube-free rate (67% vs 26%, P < 0.0001), shorter postoperative catheterization time (2.8 ± 3.8 vs 5.4 ± 5.0 days, P = 0.002) and shorter hospital stay (6.5 ± 3.6 vs 8.8 ± 5.0 days, P = 0.0001) in the trans-tract electrocoagulation group than in the non-trans-tract electrocoagulation group.
CONCLUSIONS
Trans-tract electrocoagulation in endoscopic combined intrarenal surgery is a safe and efficient procedure that decreases the need for nephrostomy tube placement after surgery.",2019,"Patients experienced a higher nephrostomy tube-free rate (67% vs 26%, P ","['patients who underwent endoscopic combined intrarenal surgery from May 2010 to March 2018', 'patients with and without trans-tract electrocoagulation']","['trans-tract electrocoagulation', 'endoscopic combined intrarenal surgery', 'Trans-tract electrocoagulation']","['shorter postoperative catheterization time', 'efficacy and safety', 'initial stone-free rates', 'shorter hospital stay', 'stone number', 'nephrostomy tube-free rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184149', 'cui_str': 'Nephrostomy tube (physical object)'}]",,0.0349913,"Patients experienced a higher nephrostomy tube-free rate (67% vs 26%, P ","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': 'Department of Urology, Miyazaki University Graduate School of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Hideyasu', 'Initials': 'H', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Urology, Nozaki Higashi Hospital, Miyazaki, Japan.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Miyake', 'Affiliation': 'Department of Urology, Nozaki Higashi Hospital, Miyazaki, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Urology, Nozaki Higashi Hospital, Miyazaki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Department of Urology, Nozaki Higashi Hospital, Miyazaki, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Urology, Miyazaki University Graduate School of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Shitamura', 'Affiliation': 'Department of Urology, Nozaki Higashi Hospital, Miyazaki, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kamimura', 'Affiliation': 'Department of Urology, Miyazaki University Graduate School of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Terada', 'Affiliation': 'Department of Urology, Miyazaki University Graduate School of Medicine, Miyazaki, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Nozaki Higashi Hospital, Miyazaki, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kamoto', 'Affiliation': 'Department of Urology, Miyazaki University Graduate School of Medicine, Miyazaki, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14120']
940,31608447,"Pharmacokinetic assessment of constituents of Boswellia serrata, pine bark extracts, curcumin in combination including methylsulfonylmethane in healthy volunteers.","OBJECTIVES
Dietary supplements are increasingly used by people with osteoarthritis. Boswellia serrata extract, curcumin, pine bark extract and methylsulfonylmethane have been identified as having the largest effects for symptomatic relief in a systematic review. It is important to understand whether any pharmacokinetic interactions are among the major constituents of these supplements so as to provide information when considering the combination use of these supplements. The aim of this study was to investigate the pharmacokinetics of the constituents alone and in combination.
METHODS
This study was a randomized, open-label, single-dose, four-treatment, four-period, crossover study with 1-week washout. The pharmacokinetics of the constituents of these supplements when dosed in combination with methylsulfonylmethane were compared to being administered alone. Plasma samples were obtained over 24 h from 16 healthy participants. Eight major constituents were analysed using a validated ultra-high-performance liquid chromatography-tandem mass spectrometry assay.
KEY FINDINGS
The pharmacokinetics of each constituent was characterized, and there were no significant differences in the pharmacokinetic profiles of the constituents when administered as a combination, relative to the constituents when administered alone (P > 0.05).
CONCLUSIONS
These data suggest that interactions between the major constituents of this supplement combination are unlikely and therefore could be investigated to manage patients with osteoarthritis without significant concerns for possible pharmacokinetic interactions.",2020,"The pharmacokinetics of each constituent was characterized, and there were no significant differences in the pharmacokinetic profiles of the constituents when administered as a combination,","['people with osteoarthritis', '16 healthy participants', 'healthy volunteers']","['methylsulfonylmethane', 'Boswellia serrata, pine bark extracts, curcumin in combination including methylsulfonylmethane']",[],"[{'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0058231', 'cui_str': 'dimethyl sulfone'}, {'cui': 'C2608032', 'cui_str': 'Boswellia serrata'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],,0.0382926,"The pharmacokinetics of each constituent was characterized, and there were no significant differences in the pharmacokinetic profiles of the constituents when administered as a combination,","[{'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Faculty of Medicine and Health, Institute of Bone and Joint Research, The Kolling Institute, Northern Clinical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Faculty of Medicine and Health, Institute of Bone and Joint Research, The Kolling Institute, Northern Clinical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Eyles', 'Affiliation': 'Faculty of Medicine and Health, Institute of Bone and Joint Research, The Kolling Institute, Northern Clinical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'Faculty of Medicine and Health, School of Pharmacy, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jeffry', 'Initials': 'J', 'LastName': 'Adiwidjaja', 'Affiliation': 'Faculty of Medicine and Health, School of Pharmacy, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Shane K', 'Initials': 'SK', 'LastName': 'Eagles', 'Affiliation': 'Faculty of Medicine and Health, School of Pharmacy, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'XiaoSuo', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Faculty of Medicine and Health, Bosch Mass Spectrometry Facility, School of Medical Sciences, The University of Sydney, Sydney, NSW, Australia.'}]",The Journal of pharmacy and pharmacology,['10.1111/jphp.13184']
941,31831529,Furosemide versus mannitol in Japanese patients with thoracic malignancy who received cisplatin-based chemotherapy using short hydration: study protocol for a randomised controlled trial.,"INTRODUCTION
Cisplatin (CDDP) is a key drug for various thoracic malignancies. To avoid renal toxicity of CDDP, mannitol is routinely used, but it sometimes causes phlebitis which damages patients' quality of life. Furosemide is another widely used option for diuresis administered more quickly. To date, previous comparisons of these diuretics have lacked statistical significance owing to study design. We therefore undertake a randomised phase II comparative study of furosemide and mannitol in CDDP-based chemotherapy using short hydration.
METHODS AND ANALYSIS
This is a two-arm, prospective, randomised, single-centre, open-label phase II study. The primary endpoint is set as the proportion of patients who experienced any grade of 'creatinine increase' using the Common Terminology Criteria for Adverse Events V.4.0, during the first cycle. Secondary endpoints are: the proportion of patients who experienced ≥grade 2 of creatinine increase during the first cycle, any grade and ≥grade 2 of creatinine increase after the completion of fourth cycle, and the proportion of patients with phlebitis. Enrolled in this trial will be 105 patients.
ETHICS AND DISSEMINATION
This study was approved by the Wakayama Medical University Institutional Review Board on 30 March 2018 study (approval number: 2258). Patients have been enrolled since May 2018. As the study will complete accrual in March 2021, results will be published by 2021. This study will provide important information about the utility of furosemide compared with mannitol to protect against nephrotoxicity.
TRIAL REGISTRATION NUMBER
UMIN000031910.",2019,"The primary endpoint is set as the proportion of patients who experienced any grade of 'creatinine increase' using the Common Terminology Criteria for Adverse Events V.4.0, during the first cycle.","['105 patients', 'Wakayama Medical University Institutional Review Board on 30 March 2018 study (approval number: 2258', 'Japanese patients with thoracic malignancy who received']","['cisplatin-based chemotherapy', 'Furosemide versus mannitol', 'Furosemide', 'furosemide', 'furosemide and mannitol', 'CDDP, mannitol', 'Cisplatin (CDDP', 'mannitol']","['proportion of patients who experienced ≥grade 2 of creatinine increase during the first cycle, any grade and ≥grade 2 of creatinine increase', ""proportion of patients who experienced any grade of 'creatinine increase""]","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151578', 'cui_str': 'Creatinine increased'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",,0.0744121,"The primary endpoint is set as the proportion of patients who experienced any grade of 'creatinine increase' using the Common Terminology Criteria for Adverse Events V.4.0, during the first cycle.","[{'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Murakami', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Akamatsu', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan h-akamat@wakayama-med.ac.jp.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University Hospital, Wakayama, Japan.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Nursing, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-029057']
942,31843821,DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care.,"INTRODUCTION
Home care clients are increasingly medically complex, have limited access to effective chronic disease management and have very high emergency department (ED) visitation rates. There is a need for more appropriate and targeted supportive chronic disease management for home care clients. We aim to evaluate the effectiveness and preliminary cost effectiveness of a targeted, person-centred cardiorespiratory management model.
METHODS AND ANALYSIS
The Detection of Indicators and Vulnerabilities of Emergency Room Trips (DIVERT) - Collaboration Action Research and Evaluation (CARE) trial is a pragmatic, cluster-randomised, multicentre superiority trial of a flexible multicomponent cardiorespiratory management model based on the best practice guidelines. The trial will be conducted in partnership with three regional, public-sector, home care providers across Canada. The primary outcome of the trial is the difference in time to first unplanned ED visit (hazard rate) within 6 months. Additional secondary outcomes are to identify changes in patient activation, changes in cardiorespiratory symptom frequencies and cost effectiveness over 6 months. We will also investigate the difference in the number of unplanned ED visits, number of inpatient hospitalisations and changes in health-related quality of life. Multilevel proportional hazard and generalised linear models will be used to test the primary and secondary hypotheses. Sample size simulations indicate that enrolling 1100 home care clients across 36 clusters (home care caseloads) will yield a power of 81% given an HR of 0.75.
ETHICS AND DISSEMINATION
Ethics approval was obtained from the Hamilton Integrated Research Ethics Board as well as each participating site's ethics board. Results will be submitted for publication in peer-reviewed journals and for presentation at relevant conferences. Home care service partners will also be informed of the study's results. The results will be used to inform future support strategies for older adults receiving home care services.
TRIAL REGISTRATION NUMBER
NCT03012256.",2019,"The Detection of Indicators and Vulnerabilities of Emergency Room Trips (DIVERT) - Collaboration Action Research and Evaluation (CARE) trial is a pragmatic, cluster-randomised, multicentre superiority trial of a flexible multicomponent cardiorespiratory management model based on the best practice guidelines.","['home care clients', 'home care', 'partnership with three regional, public-sector, home care providers across Canada', 'Home care service partners', 'older adults receiving home care services']",['cardiorespiratory management'],"['patient activation, changes in cardiorespiratory symptom frequencies and cost effectiveness', 'time to first unplanned ED visit (hazard rate']","[{'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0019855', 'cui_str': 'Domiciliary Care'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency (observable entity)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",1100.0,0.121819,"The Detection of Indicators and Vulnerabilities of Emergency Room Trips (DIVERT) - Collaboration Action Research and Evaluation (CARE) trial is a pragmatic, cluster-randomised, multicentre superiority trial of a flexible multicomponent cardiorespiratory management model based on the best practice guidelines.","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Costa', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada acosta@mcmaster.ca.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Schumacher', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Darly', 'Initials': 'D', 'LastName': 'Dash', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Campbell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Junek', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Agarwal', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Chaim M', 'Initials': 'CM', 'LastName': 'Bell', 'Affiliation': 'Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Boscart', 'Affiliation': 'Schlegel Centre for Advancing Seniors Care, Conestoga College Institute of Technology and Advanced Learning, Kitchener, Ontario, Canada.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Bronskill', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feeny', 'Affiliation': 'Department of Economics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Hébert', 'Affiliation': 'Department of Medicine, Universite de Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Heckman', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Hirdes', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'McKelvie', 'Affiliation': 'Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Mitchell', 'Affiliation': 'Home Care, Winnipeg Regional Health Authority, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Sinha', 'Affiliation': 'Departments of Medicine, Family and Community Medicine, and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Information Management, Western Health Care Corp, Corner Brook, Newfoundland, Canada.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Priddle', 'Affiliation': 'Community Support, Western Health Care Corp, Corner Brook, Newfoundland, Canada.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Rose', 'Affiliation': ""Department of Health and Community Services, Government of Newfoundland and Labrador, Saint John's, Newfoundland, Canada.""}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Gillan', 'Affiliation': 'Community Health Services, Island Health, Victoria, British Columbia, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Mills', 'Affiliation': 'Community Health Services, Island Health, Victoria, British Columbia, Canada.'}, {'ForeName': 'Dilys', 'Initials': 'D', 'LastName': 'Haughton', 'Affiliation': 'Hamilton Niagara Haldimand Brant Local Health Integration Network, Hamilton, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-030301']
943,31909725,Efficacy of a Self-Help Web-Based Recovery Training in Improving Sleep in Workers: Randomized Controlled Trial in the General Working Population.,"BACKGROUND
Sleep complaints are among the most prevalent health concerns, especially among workers, which may lead to adverse effects on health and work. Internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) offers the opportunity to deliver effective solutions on a large scale. The efficacy of iCBT-I for clinical samples has been demonstrated in recent meta-analyses, and there is evidence that iCBT-I is effective in the working population with severe sleep complaints. However, to date, there is limited evidence from randomized controlled trials that iCBT-I could also be an effective tool for universal prevention among the general working population regardless of symptom severity. Although increasing evidence suggests that negatively toned cognitive activity may be a key factor for the development and maintenance of insomnia, little is known about how iCBT-I improves sleep by reducing presleep cognitive activity.
OBJECTIVE
This study aimed to examine the efficacy of a self-help internet-delivered recovery training, based on principles of iCBT-I tailored to the work-life domain, among the general working population. General and work-related cognitive activities were investigated as potential mediators of the intervention's effect.
METHODS
A sample of 177 workers were randomized to receive either the iCBT-I (n=88) or controls (n=89). The intervention is a Web-based training consisting of six 1-week modules. As the training was self-help, participants received nothing but technical support via email. Web-based self-report assessments were scheduled at baseline, at 8 weeks, and at 6 months following randomization. The primary outcome was insomnia severity. Secondary outcomes included measures of mental health and work-related health and cognitive activity. In an exploratory analysis, general and work-related cognitive activities, measured as worry and work-related rumination, were investigated as mediators.
RESULTS
Analysis of the linear mixed effects model showed that, relative to controls, participants who received iCBT-I reported significantly lower insomnia severity scores at postintervention (between-group mean difference -4.36; 95% CI -5.59 to - 3.03; Cohen d=0.97) and at 6-month follow-up (between-group difference: -3.64; 95% CI -4.89 to -2.39; Cohen d=0.86). The overall test of group-by-time interaction was significant (P<.001). Significant differences, with small-to-large effect sizes, were also detected for cognitive activity and for mental and work-related health, but not for absenteeism. Mediation analysis demonstrated that work-related rumination (indirect effect: a 1 b 1 =-0.80; SE=0.34; 95% boot CI -1.59 to -0.25) and worry (indirect effect: a 2 b 2 =-0.37; SE=0.19; 95% boot CI -0.85 to -0.09) mediate the intervention's effect on sleep.
CONCLUSIONS
A self-help Web-based recovery training, grounded in the principles of iCBT-I, can be effective in the general working population, both short and long term. Work-related rumination may be a particularly crucial mediator of the intervention's effect, suggesting that tailoring interventions to the workplace, including components to reduce the work-related cognitive activity, might be important when designing recovery interventions for workers.
TRIAL REGISTRATION
German Clinical Trials Register DRKS00007142; https://www.drks.de/DRKS00007142.",2020,"Significant differences, with small-to-large effect sizes, were also detected for cognitive activity and for mental and work-related health, but not for absenteeism.","['Workers', 'working population with severe sleep complaints', 'A sample of 177 workers']","['iCBT', 'self-help internet-delivered recovery training', 'Self-Help Web-Based Recovery Training', 'Internet-delivered cognitive behavioral therapy']","['cognitive activity and for mental and work-related health', 'insomnia severity', 'measures of mental health and work-related health and cognitive activity', 'insomnia severity scores']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",177.0,0.144009,"Significant differences, with small-to-large effect sizes, were also detected for cognitive activity and for mental and work-related health, but not for absenteeism.","[{'ForeName': 'Doerte', 'Initials': 'D', 'LastName': 'Behrendt', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Lueneburg, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Clinical, Neuro- & Developmental Psychology, Free University Amsterdam, Amsterdam, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Spiegelhalder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Lehr', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Lueneburg, Germany.'}]",Journal of medical Internet research,['10.2196/13346']
944,30805618,Using graphic text-messaging to promote smoking cessation among first-generation Chinese and Korean male immigrants.,"First-generation Chinese and Korean male immigrants in the United States are at high risk for tobacco use. This study pilot-tested a graphic, native-language text-messaging intervention to promote smoking cessation among these groups. First-generation Chinese and Korean male immigrant smokers (N = 71) were recruited from the Washington DC area. Participants were randomly assigned to one of four conditions based on a between-subjects 2 (graphic plus text or text-only messages) � 2 (quitline information or quitting tips) design. The text-messaging intervention included 30 text messages in total and lasted one month. Participants completed an expired air carbon monoxide (CO) assessment and self-reported measures at both baseline and follow-up. Results show that, from baseline to follow-up, participants' expired air CO levels decreased significantly (P = 0.001). Attitude toward quitting also became more positive (P = 0.028). Compared with text-only messages, graphic text messages produced greater positive changes in quitting attitudes (P = 0.039) and elicited greater fear response (P = 0.005). Compared with quitting tip messages, quitline information resulted in greater regret (P = 0.016) and fear (P = 0.051). These findings suggest that graphic text-messaging can be an effective method to promote smoking cessation among first-generation Chinese and Korean male immigrants.",2019,"Compared with quitting tip messages, quitline information resulted in greater regret (P = 0.016) and fear (P = 0.051).","['Korean male immigrants', 'first-generation Chinese and Korean male immigrants', 'First-generation Chinese and Korean male immigrant smokers (N = 71) were recruited from the Washington DC area']","['graphic text-messaging to promote smoking cessation', 'subjects 2 (graphic plus text or text-only messages) � 2 (quitline information or quitting tips) design', 'graphic, native-language text-messaging intervention']","['positive changes in quitting attitudes', 'expired air CO levels', 'expired air carbon monoxide (CO) assessment and self-reported measures', 'fear response']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",71.0,0.0427894,"Compared with quitting tip messages, quitline information resulted in greater regret (P = 0.016) and fear (P = 0.051).","[{'ForeName': 'Xiaoquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Communication, George Mason University, 4400 University Drive, Fairfax, VA, USA.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Peterson', 'Affiliation': 'National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD, USA.'}, {'ForeName': 'Kyeung Mi', 'Initials': 'KM', 'LastName': 'Oh', 'Affiliation': 'School of Nursing, George Mason University, 4400 University Drive, Fairfax, VA, USA.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Communication, George Mason University, 4400 University Drive, Fairfax, VA, USA.'}]",Health education research,['10.1093/her/cyz006']
945,29728286,[Effect of a Physical activity program on self-esteem in subjects with chronic diseases. 'Pas a Pas' community intervention trial].,"AIM
To evaluate the effectiveness of a 9 months of supervised Physical Activity (PA) Program with sociocultural activities, on self-esteem and its association on the control of chronic diseases in adult primary care users.
DESIGN
Multicenter, randomized, controlled community intervention.
LOCATION
4 Primary care centers in Reus-Tarragona, Spain.
PARTICIPANTS
364 subjects, randomized to the Control Group (CG=104) and Intervention Group (IG=260).
INTERVENTION
Supervised walking program of 120min/week with sociocultural activities once a month.
MAIN MEASUREMENTS
At baseline and at post-intervention we assessed: PA (IPAQ-S), self-esteem (Rosenberg scale) and cardiovascular indicators: smoking, systolic (SBP) and diastolic (DBP) blood pressure, serum LDL and HDL cholesterol, and serum glucose. Sociodemographic characteristics and diagnostic of chronic diseases are recorded.
RESULTS
The Program increased the PA in the IG (P=.001), while it decreased in the CG (P=.002), and also the self-esteem in the group of participants (1.28 points, P=.006) and in the groups with diagnoses of hypertension (1.60 points, P=.005), dyslipidemia (1.62 points, P=.012), excess weight (1.24 points, P=.011) or anxiety/depression (1.53 points, P=.045), assessed by multivariate statistical models. The increase in self-esteem during the intervention decreased SBP -0.5mmHg (P=.030) in the hypertension group, regardless of baseline SBP and the effect of the intervention.
CONCLUSION
The PA program increased the PA and self-esteem in adult primary care users. The increase of self-esteem improved the control of SBP in hypertensive patients.",2019,"The increase in self-esteem during the intervention decreased SBP -0.5mmHg (P=.030) in the hypertension group, regardless of baseline SBP and the effect of the intervention.
","['subjects with chronic diseases. ', '364 subjects', 'hypertensive patients', 'adult primary care users']","['Physical activity program', 'supervised Physical Activity (PA) Program with sociocultural activities', 'Supervised walking program of 120min/week with sociocultural activities once a month']","['PA and self-esteem', 'dyslipidemia', 'hypertension', 'self-esteem', 'excess weight', 'PA (IPAQ-S), self-esteem (Rosenberg scale) and cardiovascular indicators: smoking, systolic (SBP) and diastolic (DBP) blood pressure, serum LDL and HDL cholesterol, and serum glucose', 'anxiety/depression']","[{'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0222045'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",364.0,0.0235747,"The increase in self-esteem during the intervention decreased SBP -0.5mmHg (P=.030) in the hypertension group, regardless of baseline SBP and the effect of the intervention.
","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Villalobos', 'Affiliation': 'Grupo de investigación en Nutrición y Salud Mental (NUTRISAM), Facultad de Medicina y Ciencias de la Salud, Instituto de Investigación Sanitaria Pere Virgili (IISPV), Universidad Rovira i Virgili, Tarragona, España.'}, {'ForeName': 'Angels', 'Initials': 'A', 'LastName': 'Vinuesa', 'Affiliation': 'Centros de Atención Primaria, Institut Català de la Salut, Reus, Tarragona, España.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'Pedret', 'Affiliation': 'Centros de Atención Primaria, Institut Català de la Salut, Reus, Tarragona, España.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Reche', 'Affiliation': 'Centros de Atención Primaria, Institut Català de la Salut, Reus, Tarragona, España.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Domínguez', 'Affiliation': 'Centros de Atención Primaria, Institut Català de la Salut, Reus, Tarragona, España.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Arija', 'Affiliation': ""Grupo de investigación en Nutrición y Salud Mental (NUTRISAM), Facultad de Medicina y Ciencias de la Salud, Instituto de Investigación Sanitaria Pere Virgili (IISPV), Universidad Rovira i Virgili, Tarragona, España; Unitat de Suport a la Recerca de Tarragona-Reus, Institut d'Investigació en Atenció Primària (IDIAP) Jordi Gol, Barcelona, España. Electronic address: victoria.arija@urv.cat.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Atencion primaria,['10.1016/j.aprim.2017.11.011']
946,31957601,Pilot Test of an Appreciative Inquiry Intervention in Hypertension Self-management.,"We implemented an Appreciative Inquiry (AI) intervention to assist people with hypertension improve diet, physical activity, and blood pressure. In a two-group randomized controlled trial conducted over 12 weeks, 50 participants were recruited at an urban outpatient health care clinic. The intervention used participants' high peak positive experiences to promote behavior change, during two face-to-face individual sessions and three coaching telephone calls. Data were analyzed using test of differences between groups and analysis of covariance controlling for confounding variables. The intervention group had significantly higher levels of ideal self, positive emotions, and self-efficacy for chronic disease management than the control group. No significant group differences in physical activity, diet, or blood pressure. Findings provide empirical evidence about the underlying processes by which AI may promote health behavior change. Future research should examine the effectiveness of this AI intervention in a larger sample of patients and over a longer intervention period.",2020,"No significant group differences in physical activity, diet, or blood pressure.","['50 participants were recruited at an urban outpatient health care clinic', 'Hypertension Self-management']","['Appreciative Inquiry Intervention', 'Appreciative Inquiry (AI) intervention']","['levels of ideal self, positive emotions, and self-efficacy for chronic disease management', 'physical activity, diet, or blood pressure']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",50.0,0.05515,"No significant group differences in physical activity, diet, or blood pressure.","[{'ForeName': 'Oluwatomisin D', 'Initials': 'OD', 'LastName': 'Olayinka', 'Affiliation': 'School of Nursing, MGH Institute of Health Professions, Boston, Massachusetts, USA.'}, {'ForeName': 'Shirley M', 'Initials': 'SM', 'LastName': 'Moore', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Kurt C', 'Initials': 'KC', 'LastName': 'Stange', 'Affiliation': 'Center for Community Health Integration, Case Western Reserve University, Cleveland, Ohio, USA.'}]",Western journal of nursing research,['10.1177/0193945919897077']
947,31957654,Long-term effects of cardiac rehabilitation on sleep apnea severity in patients with coronary artery disease.,"STUDY OBJECTIVES
Sleep apnea (SA) is prevalent among patients with coronary artery disease (CAD) and increases cardiovascular risk. A previous study showed that 1 month of cardiac rehabilitation (CR) reduced severity of SA in patients with CAD by reducing fluid accumulation in the legs during the day and the amount of fluid shifting rostrally into the neck overnight. The aim of this study was to evaluate whether CR will lead to longer-term attenuation of SA in patients with CAD.
METHODS
Fifteen patients with CAD and SA who had participated in a 1-month randomized trial of the effects of exercise training on SA were followed up until they completed 6 months of CR (age: 65 ± 10 years; body mass index: 27.0 ± 3.9 kg/m²; apnea-hypopnea index [AHI]: 39.0 ± 16.7). The AHI was evaluated at baseline by polysomnography and then at 6 months by portable monitoring at home. Cardiorespiratory fitness (VO 2peak ) was evaluated via a graded cardiopulmonary exercise test at baseline and 6 months later. The 6-month CR program included once weekly, 90-minute, in-facility exercise sessions, and 4 days per week at-home exercise sessions.
RESULTS
After 6 months of CR, there was a 54% reduction in the AHI (30.5 ± 15.2 to 14.1 ± 7.5, P < .001). Body mass index remained unchanged, but VO 2peak increased by 27% (20.0 ± 6.1 to 26.0 ± 8.9 mL/kg/min, P = .04).
CONCLUSIONS
Participation in CR is associated with a significant long-term decrease in the severity of SA. This finding suggests that attenuation of SA by exercise could be a mechanism underlying reduced mortality following participation in CR in patients with CAD and SA.
CLINICAL TRIAL REGISTRATION
This study is registered at www.controlled-trials.com with identifier number ISRCTN50108373.",2020,"Body mass index remained unchanged, but VO 2peak increased by 27% (20.0 ± 6.1 to 26.0 ± 8.9 mL/kg/min, P = .04).
","['patients with coronary artery disease (CAD) and increases cardiovascular risk', 'patients with CAD', 'patients with coronary artery disease', 'patients with CAD and SA', 'Fifteen patients with CAD and SA who had participated']","['exercise training', 'cardiac rehabilitation', 'cardiac rehabilitation (CR']","['Body mass index', 'sleep apnea severity', 'Cardiorespiratory fitness (VO 2peak ', 'VO 2peak']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0969035,"Body mass index remained unchanged, but VO 2peak increased by 27% (20.0 ± 6.1 to 26.0 ± 8.9 mL/kg/min, P = .04).
","[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Mendelson', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Inami', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Lyons', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Alshaer', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Marzolini', 'Affiliation': 'Cardiac Rehabilitation and Prevention, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oh', 'Affiliation': 'Cardiac Rehabilitation and Prevention, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'T Douglas', 'Initials': 'TD', 'LastName': 'Bradley', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8124']
948,31883426,Outcomes of patients with detectable CMV DNA at randomization in the phase III trial of letermovir for the prevention of CMV infection in allogeneic hematopoietic cell transplantation.,"Letermovir, a cytomegalovirus (CMV) terminase-complex inhibitor, is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of allogeneic hematopoietic cell transplantation (HCT). In a phase III, double-blind, randomized trial, letermovir significantly reduced the risk of clinically significant CMV infection (CS-CMVi) vs placebo through Week 24 post-HCT. This analysis investigated outcomes in participants with detectable CMV DNA at randomization, who were excluded from the primary efficacy analysis. In total, 70 of 565 randomized participants had detectable CMV DNA at randomization (letermovir 48; placebo 22). Study treatment completion rates were greater in letermovir-treated participants compared with placebo (52.1% vs 9.1%). The incidence of CS-CMVi or imputed primary endpoint events through Week 24 were 64.6% and 90.9% in the letermovir and placebo groups, respectively (treatment difference -26.1%; P = .010). Kaplan-Meier event rates for CS-CMVi onset through Week 14 (end-of-treatment period) were 33.1% for letermovir and 86.6% for placebo (P < .001). Median viral loads at the CS-CMVi events was similar in both treatment arms. All-cause mortality through Week 24 posttransplant was 15.0% for letermovir and 18.2% for placebo; through Week 48, mortality rates were 26.5% and 40.9%, respectively (P = .268). Overall, clinical outcomes were similar to those reported for participants with undetectable CMV DNA at randomization.",2020,"All-cause mortality through Week 24 post-transplantation was 15.0% for letermovir and 18.2% for placebo; through Week 48, mortality rates were 26.5% and 40.9%, respectively (p=0.268).","['participants with detectable CMV DNA at randomization, who were excluded from the primary efficacy analysis', 'adult CMV-seropositive recipients of allogeneic hematopoietic cell transplantation (HCT', 'patients with detectable CMV DNA at randomization in the phase III trial of', 'allogeneic hematopoietic cell transplantation']","['placebo', 'letermovir']","['risk of clinically-significant CMV infection', 'incidence of CS-CMVi', 'Median viral loads', 'mortality rates']","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852938', 'cui_str': 'letermovir'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",565.0,0.611867,"All-cause mortality through Week 24 post-transplantation was 15.0% for letermovir and 18.2% for placebo; through Week 48, mortality rates were 26.5% and 40.9%, respectively (p=0.268).","[{'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Per T', 'Initials': 'PT', 'LastName': 'Ljungman', 'Affiliation': 'Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Roy F', 'Initials': 'RF', 'LastName': 'Chemaly', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, Texas.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Teal', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Butterton', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Wendy W', 'Initials': 'WW', 'LastName': 'Yeh', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Randi Y', 'Initials': 'RY', 'LastName': 'Leavitt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Cyrus S', 'Initials': 'CS', 'LastName': 'Badshah', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15764']
949,31606448,"Transcranial direct current stimulation reduces seizure frequency in patients with refractory focal epilepsy: A randomized, double-blind, sham-controlled, and three-arm parallel multicenter study.","BACKGROUND
Transcranial direct current stimulation (tDCS) has been explored in epilepsy with limited samples, varied parameters, and inconclusive results. We aimed to study the efficacy of tDCS for patients with refractory focal epilepsy.
METHOD
We conducted a randomized, double-blind, sham-controlled, and three-arm (Group 1 (sham), Group 2 (20-min), and Group 3 (2 × 20-min)) tDCS parallel multicenter study. The primary outcome measurement was seizure frequencies (SFs). The study consisted of 28-days baseline, 14-days treatment, and 56-days follow-up. The cathode was placed over the epileptogenic focus, and the current intensity was 2 mA. The generalized estimating equations model, one-way analysis of variance, chi-square and Kruskal-Wallis test were used for analysis.
RESULTS
Of the 82 enrolled patients, 70 patients were included for final analysis (Group 1, n = 21; Group 2, n = 24; and Group 3, n = 25). There was a significant reduction in SFs for both active tDCS groups compared with the sham group. Patients in Group 2 showed a significantly 50.73-21.91% greater reduction in SFs that lasted for 4 weeks (p = 0.008-0.060). Patients in Group 3 showed a significantly 63.19-49.79% greater reduction in SFs compared with the sham group that lasted for 5 weeks (p = 0.011-0.045). Patients in Group 3 had a 64.98-66.32% greater reduction in SFs at W9-W10, when compared with Group 2 (p = 0.021-0.022).
CONCLUSION
Fourteen consecutive days tDCS significantly decreased SFs in patients with refractory focal epilepsy, with 2 × 20-min daily stimulation protocol being superior to 20-min daily stimulation protocol.",2020,Patients in Group 3 showed a significantly 63.19-49.79% greater reduction in SFs compared with the sham group that lasted for 5 weeks (p = 0.011-0.045).,"['82 enrolled patients', '70 patients were included for final analysis (Group 1, n\u202f=\u202f21; Group 2, n\u202f=\u202f24; and Group 3, n\u202f=\u202f25', 'patients with refractory focal epilepsy']","['Transcranial direct current stimulation', 'tDCS', 'Transcranial direct current stimulation (tDCS']","['seizure frequency', 'seizure frequencies (SFs', 'reduction in SFs at W9-W10', 'SFs', 'reduction in SFs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0014547', 'cui_str': 'Focal Seizure Disorder'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",82.0,0.303247,Patients in Group 3 showed a significantly 63.19-49.79% greater reduction in SFs compared with the sham group that lasted for 5 weeks (p = 0.011-0.045).,"[{'ForeName': 'Dongju', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Beijing Key Laboratory of Neuromodulation, Beijing, China; Department of Neurology, Beijing Tiantan Hosipital, Capital Medical University, Beijing, China; China National Clinical Research Center for Neurological Diseases, Beijing, 100070, China; Center of Epilepsy, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Functional Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': ""Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hosipital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Qiaoyi', 'Initials': 'Q', 'LastName': 'Du', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Ruihua', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatric Medicine, Beijing Luhe Hospital, Affiliated to Capital Medical University, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Yicong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Qinlan', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hosipital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hosipital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Pediatric, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Pediatric, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Department of Neurology, Beijing Luhe Hospital, Affiliated to Capital Medical University, China.'}, {'ForeName': 'Yulian', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Qihui', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Qilin', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hosipital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hosipital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': ""Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Huini', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Jishui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Mental Health, Beijing Children's Hospital, Capital Medical University, Beijing, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Geriatric Medicine, Beijing Luhe Hospital, Affiliated to Capital Medical University, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Department of Evidence-Based Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Center of Epilepsy, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China. Electronic address: mdwangyp@sina.cn.'}]",Brain stimulation,['10.1016/j.brs.2019.09.006']
950,31937442,Kinesiotaping for isolated rib fractures in emergency department.,"INTRODUCTION
Rib fractures, which are among the most common injuries in blunt thoracic trauma, are usually encountered in Emergency Departments. Kinesiotape (KT) is a drug-free elastic therapeutic tape used for treating various musculoskeletal problems such as injury, dysfunction and pain. We aimed to investigate whether kinesotaping should be used safely and effectively in rib fractures in emergency setting.
MATERIALS AND METHODS
This was a prospective, randomized controlled study conducted in an Emergency Department of a University Hospital. Patients diagnosed with isolated rib fractures were included in the study. Pain severity of patients assessed with 0-10 cm visual analog scale (VAS), then patients assigned into 2 treatment groups. One of them received treatment with flurbiprofen 200 mg/day and the other group received kinesiotaping in addition to the same oral therapy. On the 4th day of the procedure, both groups were assessed with VAS in the followup visit.
RESULTS
Total of 82 patients presented with rib fractures, 52 of them were excluded. Remaining 30 constituted the study group and randomly allocated to kinesiotaping (n = 16) or control group (n = 14). In both groups, pain intensity on the 4th day was significantly reduced when compared with baseline (p for both<0.01). Additionally, considering the reducing the pain intensity on 4th day, kinesiotaping was significantly superior than the control group (p < 0.01).
CONCLUSION
This study investigated the use of kinesiotaping in emergency departments. When compared to NSAID therapy alone, combined kinesiotaping and NSAID therapy appears to be more effective in terms of pain reduction in rib fractures.",2020,"Additionally, considering the reducing the pain intensity on 4th day, kinesiotaping was significantly superior than the control group (p < 0.01).
","['rib fractures in emergency setting', 'emergency departments', 'Total of 82 patients presented with rib fractures, 52 of them were excluded', 'Patients diagnosed with isolated rib fractures', 'isolated rib fractures in emergency department', 'Emergency Department of a University Hospital']","['NSAID therapy alone, combined kinesiotaping and NSAID therapy', 'Kinesiotape (KT', 'flurbiprofen']","['pain reduction', 'pain intensity', 'Pain severity']","[{'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0016377', 'cui_str': 'Flurbiprofen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",82.0,0.0341479,"Additionally, considering the reducing the pain intensity on 4th day, kinesiotaping was significantly superior than the control group (p < 0.01).
","[{'ForeName': 'Ali Haydar', 'Initials': 'AH', 'LastName': 'Akça', 'Affiliation': 'Yüzüncü Yıl University, Faculty of Medicine, Department of Emergency Medicine, Turkey.'}, {'ForeName': 'Muhammed İkbal', 'Initials': 'Mİ', 'LastName': 'Şaşmaz', 'Affiliation': 'Manisa Celal Bayar University, Faculty of Medicine, Department of Emergency Medicine, Turkey. Electronic address: ikbalsasmaz@hotmail.com.'}, {'ForeName': 'Şeyhmus', 'Initials': 'Ş', 'LastName': 'Kaplan', 'Affiliation': 'Yüzüncü Yıl University, Faculty of Medicine, Department of Sports Medicine, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.11.049']
951,30016404,"Comparison of Energy-Based Tissue Dissection Techniques in Abdominoplasty: A Randomized, Open-Label Study Including Economic Aspects.","BACKGROUND
Abdominoplasty is one of the most common procedures in plastic surgery, and energy-based tissue dissection techniques have become the gold standard. Despite its frequency, abdominoplasty is still associated with high complication rates.
OBJECTIVES
The authors compared clinical and economic data of 4 methods of energy-based tissue dissection in a randomized, open-label study.
METHODS
A total of 57 patients were preoperatively randomized into 4 groups: electrocautery, Ultracision Harmonic Scalpel, argon plasma coagulation, and PEAK-Plasmablade. Demographic and operational data as well as information on the postoperative course and complications were collected. For economic analysis, quotes were obtained from the device companies or official suppliers.
RESULTS
Duration of surgery, drainage quantity, and wound healing complications did not differ significantly between groups. The Ultracision method caused significantly greater blood loss compared with all other techniques (P < 0.01). PEAK and Ultracision devices entailed greater surgical costs compared with APC and electrocautery.
CONCLUSIONS
All methods evaluated can be applied safely and effectively in abdominoplasty procedures. However, these data demonstrate a significantly higher blood loss for the Ultracision Harmonic Scalpel. Considering the clinical data, the higher costs of PEAK and Ultracision methods appear unjustified.
LEVEL OF EVIDENCE: 2
",2019,The Ultracision method caused significantly greater blood loss compared with all other techniques (P < 0.01).,"['57 patients', 'Abdominoplasty']","['Energy-Based Tissue Dissection Techniques', 'energy-based tissue dissection', 'electrocautery, Ultracision Harmonic Scalpel, argon plasma coagulation, and PEAK-Plasmablade']","['blood loss', 'Duration of surgery, drainage quantity, and wound healing complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",57.0,0.054518,The Ultracision method caused significantly greater blood loss compared with all other techniques (P < 0.01).,"[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Duscher', 'Affiliation': 'Department for Plastic Surgery and Hand Surgery, Klinikum rechts der Isar, Technical University of Munich, Germany.'}, {'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Aitzetmüller', 'Affiliation': 'Department for Plastic Surgery and Hand Surgery, Klinikum rechts der Isar, Technical University of Munich, Germany.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Shan', 'Affiliation': 'Kepler University Hospital Linz, Linz, Austria.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Wenny', 'Affiliation': 'Kepler University Hospital Linz, Linz, Austria.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Brett', 'Affiliation': 'Department for Plastic Surgery and Hand Surgery, Klinikum rechts der Isar, Technical University of Munich, Germany.'}, {'ForeName': 'Clement J', 'Initials': 'CJ', 'LastName': 'Staud', 'Affiliation': 'Kepler University Hospital Linz, Linz, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kiesl', 'Affiliation': 'Kepler University Hospital Linz, Linz, Austria.'}, {'ForeName': 'Georg M', 'Initials': 'GM', 'LastName': 'Huemer', 'Affiliation': 'Kepler University Hospital Linz, Linz, Austria.'}]",Aesthetic surgery journal,['10.1093/asj/sjy177']
952,31599079,Validity and reliability of the 6-min step test in individuals with coronary artery disease.,"OBJECTIVE
To assess the validity and reliability of the 6-min step test (6MST) in individuals with coronary artery disease (CAD).
METHODS
In a randomized and crossover design, 35 patients with CAD (65.8 ± 9.6 years), referred by a physician of a cardiology ambulatory, performed two 6MSTs and two 6-min walk tests (6MWTs) in order to assess reliability in patients with arterial coronary disease. The order of performance of the tests was established by a draw.
RESULTS
6MST test-retest reliability was excellent (intraclass correlation coefficient = 0.967; 95% CI: 0.766, 0.989; p < .05). There was an increase of 7.9 ± 8.2 steps from the first to the second 6MST, with a technical error of measurement = 8.0; p < .001. The correlations between distance walked in the 6MWT and number of steps in the 6MST in the first and second tests were 0.6 and 0.7 (p < .001), respectively.
CONCLUSION
The 6MST is a reliable test to measure functional capacity in individuals with CAD. The test is valid when using 6MWT as the gold standard. There is an 88% chance of a subject classified in a given tertile by the 6MWT being in the same tertile in the 6MST.",2020,"RESULTS
6MST test-retest reliability was excellent (intraclass correlation coefficient = 0.967; 95% CI: 0.766, 0.989; p < .05).","['individuals with coronary artery disease (CAD', '35 patients with CAD (65.8 ± 9.6 years), referred by a physician of a cardiology ambulatory, performed two', 'individuals with coronary artery disease', 'patients with arterial coronary disease', 'individuals with CAD']","['6MST', '6MSTs and two 6-min walk tests (6MWTs']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",[],,0.0263178,"RESULTS
6MST test-retest reliability was excellent (intraclass correlation coefficient = 0.967; 95% CI: 0.766, 0.989; p < .05).","[{'ForeName': 'Cristiane de Fátima', 'Initials': 'CF', 'LastName': 'Travensolo', 'Affiliation': 'Physical Education Department, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Juliano Ferreira', 'Initials': 'JF', 'LastName': 'Arcuri', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Marcos Doederlein', 'Initials': 'MD', 'LastName': 'Polito', 'Affiliation': 'Physical Education Department, Londrina State University, Londrina, Brazil.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1810']
953,31823444,"Randomized, double-blind, 6-week non-inferiority study of lurasidone and risperidone for the treatment of schizophrenia.","AIM
The aim of the present study was to evaluate the efficacy and safety of lurasidone for the treatment of Chinese schizophrenic patients.
METHODS
Hospitalized schizophrenia patients aged 18-65 were randomized to 6 weeks of double-blind, double-dummy, flexible-dose treatment with lurasidone (40 or 80 mg/day) or risperidone (2, 4 or 6 mg/day). Efficacy was evaluated using a non-inferiority comparison of lurasidone relative to risperidone based on week 6 change in the Positive and Negative Syndrome Scale (PANSS) total score. Safety assessments included adverse events, clinical laboratory measures, and electrocardiograms.
RESULTS
Four hundred and forty-four patients were screened to obtain an intent-to-treat sample of 384 patients, of whom 54 patients discontinued treatment prior to 6 weeks. Lurasidone met the criteria for non-inferiority versus risperidone on the PANSS total score. Adjusted mean (SE) change at week 6 on the PANSS total score was -31.2 (1.0) and -34.9 (1.0) in the lurasidone and risperidone group, respectively. The mean difference score was 3.7, and the upper boundary of the 95%-confidence interval (1.0-6.3) was less than the prespecified margin of 7.0. No clinically meaningful between-treatment group differences were evident on secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales. The incidence of adverse events was lower for lurasidone vs risperidone for extrapyramidal symptoms (17.0% vs 38.2%), akathisia (7.2% vs 13.6%), prolactin increase (3.1% vs 14.1%), and weight increase (0.5% vs 5.2%).
CONCLUSION
Lurasidone was found to be non-inferior to risperidone on the primary endpoint with minimal effects on weight, metabolic parameters, or prolactin levels.",2020,"No clinically meaningful between-treatment group differences were evident on secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales.","['Four hundred and forty-four patients were screened to obtain an intent-to-treat sample of 384 patients, of whom 54 patients discontinued treatment prior to 6\u2009weeks', 'Hospitalized schizophrenia patients aged 18-65', 'schizophrenia', 'Chinese schizophrenic patients']","['lurasidone and risperidone', 'lurasidone', 'risperidone']","['akathisia', 'efficacy and safety', 'weight increase', 'Efficacy', 'incidence of adverse events', 'adverse events, clinical laboratory measures, and electrocardiograms', 'weight, metabolic parameters, or prolactin levels', 'prolactin increase', 'extrapyramidal symptoms', 'secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0553731', 'cui_str': 'PRL increased'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",444.0,0.0943473,"No clinically meaningful between-treatment group differences were evident on secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Psychiatry, Beijing Anding Hospital, National Clinical Research Center for Mental Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Department of Psychiatry, Xi'an Mental Health Center, Xi'an, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Tianjin Anding Hospital, Tianjin, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Wuxi Mental Health Center, Wuxi, China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Psychiatry, Beijing Huilongguan Hospital, Beijing, China.'}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychiatry, Henan Provincial Mental Hospital, Xinxiang, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Department of Psychiatry, Guangzhou Brain Hospital, Guangzhou, China.'}, {'ForeName': 'Shiping', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Department of Psychiatry, Nanjing Brain Hospital, Nanjing, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Brain Hospital of Hunan Province, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Sixth Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Keqing', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Hebei Mental Health Center, Baoding, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Mental Health Institute, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lehua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Psychiatry, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Medical Division, Sumitomo Pharma(Suzhou)Co., Ltd, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Beijing Anding Hospital, National Clinical Research Center for Mental Disorders, Capital Medical University, Beijing, China.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.12965']
954,31545507,"Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II randomized, double-blind BOLT study.","BACKGROUND
Basal cell carcinomas (BCCs) exhibit aberrant activation of the hedgehog pathway. Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT study [Basal Cell Carcinoma Outcomes with LDE225 (sonidegib) Treatment].
OBJECTIVES
This is the final 42-month analysis of the BOLT study, evaluating the efficacy and safety of sonidegib.
METHODS
Adults with no prior hedgehog pathway inhibitor therapy were randomized in a 1 : 2 ratio to sonidegib 200 mg or 800 mg once daily. Treatment continued for up to 42 months or until disease progression, unacceptable toxicity, death, study termination or withdrawal of consent. The primary efficacy end point was the objective response rate (ORR) by central review, assessed at baseline; weeks 5, 9 and 17; then subsequently every 8 or 12 weeks during years 1 or 2, respectively. Safety end points included adverse event monitoring and reporting.
RESULTS
The study enrolled 230 patients, 79 and 151 in the 200-mg and 800-mg groups, respectively, of whom 8% and 3.3% remained on treatment by the 42-month cutoff, respectively. The ORRs by central review were 56% [95% confidence interval (CI) 43-68] for laBCC and 8% (95% CI 0·2-36) for mBCC in the 200-mg group and 46·1% (95% CI 37·2-55·1) for laBCC and 17% (95% CI 5-39) for mBCC in the 800-mg group. No new safety concerns emerged.
CONCLUSIONS
Sonidegib demonstrated sustained efficacy and a manageable safety profile. The final BOLT results support sonidegib as a viable treatment option for laBCC and mBCC. What's already known about this topic? Basal cell carcinoma (BCC) is usually treatable with surgery or radiation therapy, but there are limited treatment options for patients with advanced BCC. Sonidegib, a hedgehog pathway inhibitor approved for the treatment of advanced BCC, demonstrated clinically relevant efficacy and manageable safety in prior analyses of the phase II randomized, double-blind BOLT study [Basal Cell Carcinoma Outcomes with LDE225 (sonidegib) Treatment]. What does this study add? This final 42-month analysis of BOLT is the longest follow-up available for a hedgehog pathway inhibitor. Clinically relevant efficacy results were sustained from prior analyses, with objective response rates by central review of the approved 200-mg daily dose of 56% in locally advanced BCC and 8% in metastatic BCC. No new safety concerns were raised. The results confirmed sonidegib as a viable long-term treatment option for patients with advanced BCC.",2020,"Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT (Basal Cell Carcinoma Outcomes with LDE225 [sonidegib] Treatment) study.
","['Adults with no prior hedgehog pathway inhibitor therapy', 'patients with advanced basal cell carcinoma', 'The study enrolled 230 patients, 79 and 151 in the 200 mg and 800 mg groups, respectively, of whom 8% and 3% remained on treatment by the 42-month cutoff, respectively']","['sonidegib 200 mg or 800 mg once daily', 'sonidegib']","['adverse event monitoring and reporting', 'unacceptable toxicity, death, study termination, or withdrawal of consent', 'objective response rate (ORR) by central review']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1265465', 'cui_str': 'Subfamily Erinaceinae'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007117', 'cui_str': 'Epithelioma, Basal Cell'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C4047161', 'cui_str': 'sonidegib 200 MG'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3886731', 'cui_str': 'sonidegib'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",230.0,0.123833,"Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT (Basal Cell Carcinoma Outcomes with LDE225 [sonidegib] Treatment) study.
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University of Zürich, Skin Cancer Center, University Hospital, Zürich, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guminksi', 'Affiliation': 'Department of Medical Oncology, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center Hannover, Department of Dermatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Lear', 'Affiliation': 'Manchester Academic Health Science Centre, Manchester University and Salford Royal NHS Trust, Manchester, U.K.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Cancer Center, Anschutz, Aurora, CO, U.S.A.'}, {'ForeName': 'A L S', 'Initials': 'ALS', 'LastName': 'Chang', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, CA, U.S.A.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Combemale', 'Affiliation': 'Department of Dermatology, Hôpitaux Universitaires de Lyon, Université de Lyon, Lyon, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Saint-Augustinus Hospital, Antwerp, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kaatz', 'Affiliation': 'Department of Dermatology, SRH Waldklinikum, Gera, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kudchadkar', 'Affiliation': 'Emory University, Atlanta, GA, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Northern Centre for Cancer Care, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Schulze', 'Affiliation': 'Department of Dermatology, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Stratigos', 'Affiliation': 'First Department of Dermatology-Venereology, National and Kapodistrian University of Athens School of Medicine, Andreas Sygros Hospital for Skin and Venereal Diseases, Athens, Greece.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Trefzer', 'Affiliation': 'Department of Dermatology, University Hospital Charite, Berlin, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Squittieri', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, NJ, U.S.A.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Migden', 'Affiliation': 'Departments of Dermatology and Head and Neck Surgery, The University of Texas-MD Anderson Cancer Center, Houston, TX, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18552']
955,31247117,"A Clinical Drug-Drug Interaction Study Assessing a Novel Drug Transporter Phenotyping Cocktail With Adefovir, Sitagliptin, Metformin, Pitavastatin, and Digoxin.","A new probe drug cocktail containing substrates of important drug transporters was tested for mutual interactions in a clinical trial. The cocktail consisted of (predominant transporter; primary phenotyping metric): 10 mg adefovir-dipivoxil (OAT1; renal clearance (CL R )), 100 mg sitagliptin (OAT3; CL R ), 500 mg metformin (several renal transporters; CL R ), 2 mg pitavastatin (OATP1B1; clearance/F), and 0.5 mg digoxin (intestinal P-gp, renal P-gp, and OATP4C1; peak plasma concentration (C max ) and CL R ). Using a randomized six-period, open change-over design, single oral doses were administrated either concomitantly or separately to 24 healthy male and female volunteers. Phenotyping metrics were evaluated by noncompartmental analysis and compared between periods by the standard average bioequivalence approach (boundaries for ratios 0.80-1.25). Primary metrics supported the absence of relevant interactions, whereas secondary metrics suggested that mainly adefovir was a victim of minor drug-drug interactions (DDIs). All drugs were well tolerated. This cocktail may be another useful tool to assess transporter-based DDIs in vivo.",2019,All drugs were well tolerated.,['24 healthy male and female volunteers'],"['adefovir-dipivoxil (OAT1; renal clearance [CL R ]), 100 mg sitagliptin (OAT3; CL R ), 500 mg metformin (several renal transporters; CL R ), 2 mg pitavastatin (OATP1B1; clearance/F) and 0.5 mg digoxin (intestinal P-gp, renal P-gp and OATP4C1; C max and CL R ', 'Adefovir, Sitagliptin, Metformin, Pitavastatin and Digoxin']",['tolerated'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0540694', 'cui_str': 'adefovir dipivoxil'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0050175', 'cui_str': 'adefovir'}]",[],24.0,0.04956,All drugs were well tolerated.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Trueck', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Chih-Hsuan', 'Initials': 'CH', 'LastName': 'Hsin', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Scherf-Clavel', 'Affiliation': 'Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Schaeffeler', 'Affiliation': 'Dr. Margarete-Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany.'}, {'ForeName': 'Rebekka', 'Initials': 'R', 'LastName': 'Lenssen', 'Affiliation': 'Hospital Pharmacy, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Malaz', 'Initials': 'M', 'LastName': 'Gazzaz', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Gersie', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Taubert', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Quasdorff', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwab', 'Affiliation': 'University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kinzig', 'Affiliation': 'Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Sörgel', 'Affiliation': 'Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Stoffel', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Fuhr', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1564']
956,31893730,Individual predictors of response to biofeedback training for second-language production.,"While recent research suggests that visual biofeedback can facilitate speech production training in clinical populations and second language (L2) learners, individual learners' responsiveness to biofeedback is highly variable. This study investigated the hypothesis that the type of biofeedback provided, visual-acoustic versus ultrasound, could interact with individuals' acuity in auditory and somatosensory domains. Specifically, it was hypothesized that learners with lower acuity in a sensory domain would show greater learning in response to biofeedback targeting that domain. Production variability and phonological awareness were also investigated as predictors. Sixty female native speakers of English received 30 min of training, randomly assigned to feature visual-acoustic or ultrasound biofeedback, for each of two Mandarin vowels. On average, participants showed a moderate magnitude of improvement (decrease in Euclidean distance from a native-speaker target) across both vowels and biofeedback conditions. The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research. Specifically, high phonological awareness and low production variability post-training were associated with better outcomes, although these effects were mediated by vowel target. This line of research could have implications for personalized learning in both L2 pedagogy and clinical practice.",2019,"The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research.","[""individuals' acuity in auditory and somatosensory domains"", 'Sixty female native speakers of English received']","['visual biofeedback', '30\u2009min of training, randomly assigned to feature visual-acoustic or ultrasound biofeedback', 'visual-acoustic versus ultrasound', 'biofeedback training']","['Euclidean distance', 'Production variability and phonological awareness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",60.0,0.0456901,"The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research.","[{'ForeName': 'Joanne Jingwen', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Ayala', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Harel', 'Affiliation': 'Department of Applied Statistics, Social Science, and Humanities, New York University, 246 Greene Street, 3rd Floor, New York, New York 10003, USA.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Shiller', 'Affiliation': ""École d'orthophonie et d'audiologie, Université de Montréal, Case Postale 6128, Succursale Centre-ville, Montréal, Québec, H3C 3J7, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McAllister', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}]",The Journal of the Acoustical Society of America,['10.1121/1.5139423']
957,31870925,A Prospective Randomized Blinded Trial of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery.,"Remote ischemic preconditioning (RIPC) has been proposed as an intervention to protect myocardium and attenuate end-organ dysfunction associated with cardiopulmonary bypass. We investigated the effect of RIPC in children undergoing cardiopulmonary bypass involving clinical outcome, cardiac and end-organ function, inflammatory response, and myocardial gene expression. A prospective, investigator-blinded, randomized, controlled trial was performed. Patients were randomized into RIPC or Control; RIPC consisted of three 5-minute cycles of limb ischemia-reperfusion taking place 1 and 12 hours preoperatively. Clinical outcomes included cardiac function, ICU surveillance, and renal function. In addition, inflammatory markers and myocardial gene expression were evaluated. RIPC patients required shorter ICU stay (days), RIPC: 1.8 (0.94-3.88) vs Control: 4.9 (1.63-7.20), P = 0.029. Echocardiography parameters demonstrated reduced biventricular function following surgery showing no difference between groups. A nonsignificant trend for reduced troponin was observed following RIPC: AUC analysis, RIPC: 393.05 (98.85-1038.73) vs Control: 596.10 (225.38-954.24) P = 0.75. B-type natriuretic peptide and renal function parameters were similar between groups. Postoperative TNF-α was significantly reduced after RIPC, RIPC: 15.42 (7.81-114.86) vs Control: 108.98 (42.28-301.19) P = 0.02. Remaining inflammatory markers demonstrated no significant difference between groups. HSP-60 showed lower myocardial expression following RIPC, RIPC: 3.95 (2.69-6.28) vs Control: 6.83 (4.74-8.81), P = 0.05. Expression of other analyzed genes was not influenced by RIPC. RIPC was associated with shorter ICU stay and reduced TNF-α but did not influence other clinical outcomes, not confer protection against cardiac injury or renal dysfunction. The association between RIPC and ICU stay may be influenced by unaccounted latent variables, including cardiac morphology.",2020,"RIPC was associated with shorter ICU stay and reduced TNF-α but did not influence other clinical outcomes, not confer protection against cardiac injury or renal dysfunction.","['children undergoing CPB involving', 'children undergoing cardiac surgery']","['limb ischemia-reperfusion taking place one and twelve hours pre-operatively', 'RIPC or control; RIPC', 'RIPC', 'Remote ischaemic preconditioning (RIPC', 'Remote Ischaemic Preconditioning']","['cardiac function, ICU surveillance and renal function', 'BNP and renal function parameters', 'reduced Troponin', 'shorter ICU stay', 'clinical outcome, cardiac and end-organ function, inflammatory response and myocardial gene expression', 'shorter ICU stay and reduced TNF-α', 'myocardial expression', 'protection against cardiac injury or renal dysfunction', 'bi-ventricular function', 'inflammatory markers and myocardial gene expression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]",,0.337321,"RIPC was associated with shorter ICU stay and reduced TNF-α but did not influence other clinical outcomes, not confer protection against cardiac injury or renal dysfunction.","[{'ForeName': 'Maribel Carolina', 'Initials': 'MC', 'LastName': 'Verdesoto Rodriguez', 'Affiliation': 'University of Glasgow, Glasgow, United Kingdom. Electronic address: maribelcvr@hotmail.com.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Spenceley', 'Affiliation': ""Royal Children's Hospital, Glasgow, United Kingdom.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ilina', 'Affiliation': ""Royal Children's Hospital, Glasgow, United Kingdom.""}, {'ForeName': 'Mark H D', 'Initials': 'MHD', 'LastName': 'Danton', 'Affiliation': ""Royal Children's Hospital, Glasgow, United Kingdom.""}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2019.12.004']
958,31857014,Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.,"OBJECTIVES
This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation.
BACKGROUND
Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR).
METHODS
This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days.
RESULTS
Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001).
CONCLUSIONS
Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).",2019,"patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = ","['Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California', 'Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n\xa0=\xa0151) or RV (n\xa0=\xa0152) stimulation groups']","['standard right ventricular (RV) stimulation', 'Left Ventricular Rapid Pacing Via', 'LV or RV stimulation', 'Transcatheter Aortic Valve Replacement', 'Via\xa0the Valve Delivery Guide-wire in TAVR', 'left ventricular (LV) stimulation via a guidewire-reduced procedure duration']","['procedural success', 'efficacy, safety, and cost at 30\xa0days', 'procedure duration', '30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement', 'fluoroscopy time', 'Safety of stimulation', 'procedure duration, fluoroscopy time, and cost, with similar efficacy and safety', 'Effective stimulation', 'Mean procedure duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0181089', 'cui_str': 'Catheter guide wire'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",307.0,0.147618,"patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = ","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Faurie', 'Affiliation': 'Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France. Electronic address: faurieb@gmail.com.'}, {'ForeName': 'Géraud', 'Initials': 'G', 'LastName': 'Souteyrand', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Staat', 'Affiliation': 'Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Godin', 'Affiliation': 'Cardiology Department, Clinique Saint Hilaire, Rouen, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caussin', 'Affiliation': 'Cardiology Department, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Département de cardiologie, Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Lille, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Mangin', 'Affiliation': 'Cardiology Department, Centre Hospitalier Annecy Genevois, Epagny, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Meyer', 'Affiliation': 'Cardiology Department, Institut Arnault Tzanck, Saint-Laurent-du-Var, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Cardiology Department, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdellaoui', 'Affiliation': 'Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Monségu', 'Affiliation': 'Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""Cardiology Department, URC-Eco Île de France, Hôpital de l'Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.029']
959,31881995,"Cognitive behavioural therapy for the treatment of late life depression: study protocol of a multicentre, randomized, observer-blinded, controlled trial (CBTlate).","BACKGROUND
Late-life depression (LLD) is one of the most prevalent mental disorders in old age. It is associated with various adverse outcomes and frequent use of health care services thereby remaining a serious public health concern. Compared with depression in early adulthood, most treatment options of LLD are less effective. Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects. Although cognitive behavioural therapy (CBT) is highly established and effective in depression in young and mid-life there is only a limited number of small studies on CBT in LLD. An LLD-specific CBT has not yet been compared to an active, but unspecific supportive psychological intervention in a multicentre trial.
METHODS
Here we present the design of the CBTlate trial, which is a multicentre, randomized, observer-blinded, active-controlled, parallel group trial. CBTlate aims at including 248 patients with LLD of both genders at 7 sites in Germany. The purpose of the study is to test the hypothesis that a 15-session individually-delivered CBT specific for LLD is of superior efficacy in reducing symptoms of depression in comparison with a supportive unspecific intervention (SUI) of the same quantity. The intervention includes 8 weeks of individual treatment sessions twice per week and a follow-up period of 6 months after randomization. The primary end point is the severity of depression at the end of treatment measured by the self-rated 30-item Geriatric Depression Scale (GDS). Secondary endpoints include depressive symptoms at week 5 and at follow-up (6 months after randomization). Additional secondary endpoints include the change of depressive symptoms assessed with a clinician-rating-scale and a patient reported outcome instrument for major depressive disorder, anxiety symptoms, sleep, cognition, quality of life, and overall health status from baseline to end-of treatment and to end of follow-up. Add-on protocols include MRI and the collection of blood samples.
DISCUSSION
This study is the first multicentre trial of a specific CBT intervention for LLD compared to an unspecific supportive psychological intervention administered in a specialist setting. It has important implications for developing and implementing efficient psychotherapeutic strategies for LLD and may be a significant step to broaden treatment options for people suffering from LLD.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT03735576, registered on 24 October 2018); DRKS (DRKS00013769, registered on 28 June 2018).",2019,Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects.,"['248 patients with LLD of both genders at 7 sites in Germany', 'people suffering from LLD', 'late life depression']","['cognitive behavioural therapy (CBT', 'Cognitive behavioural therapy', 'specific CBT intervention', 'Psychotherapy']","['change of depressive symptoms assessed with a clinician-rating-scale and a patient reported outcome instrument for major depressive disorder, anxiety symptoms, sleep, cognition, quality of life, and overall health status from baseline to end-of treatment and to end of follow-up', 'severity of depression at the end of treatment measured by the self-rated 30-item Geriatric Depression Scale (GDS', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0222045'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}]",248.0,0.124931,Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects.,"[{'ForeName': 'Forugh S', 'Initials': 'FS', 'LastName': 'Dafsari', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Kerpener Straße 62, 50931, Cologne, Germany. forugh.salimi-dafsari@uk-koeln.de.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Bewernick', 'Affiliation': 'Department of Neurodegenerative Diseases and Geriatric Psychiatry, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Biewer', 'Affiliation': 'Clinical Trials Centre Cologne, Gleueler Str 269, 50935, Cologne, Germany.'}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Christ', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Kerpener Str 62, 50931, Cologne, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Domschke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 5, 79104, Freiburg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Froelich', 'Affiliation': 'Department of Geriatric Psychiatry Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, 68159, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Kerpener Str 62, 50931, Cologne, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Luppa', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, University of Leipzig, 01403, Leipzig, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Peters', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Ramirez', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Kerpener Straße 62, 50931, Cologne, Germany.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Riedel-Heller', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, University of Leipzig, 01403, Leipzig, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 5, 79104, Freiburg, Germany.'}, {'ForeName': 'Magnus-Sebastian', 'Initials': 'MS', 'LastName': 'Vry', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 5, 79104, Freiburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Department of Neurodegenerative Diseases and Geriatric Psychiatry, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Eberhard Karls University, Schleichstraße 4, 72076, Tuebingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jessen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Kerpener Straße 62, 50931, Cologne, Germany.'}]",BMC psychiatry,['10.1186/s12888-019-2412-0']
960,31487422,The effectiveness of endoscopic sphenopalatine ganglion block in management of postoperative pain after septal surgery.,"BACKGROUND
This study evaluated the effect of bilateral endoscopic sphenopalatine ganglion block (SPGB) for management of postoperative pain in patients undergoing septoplasty.
METHODS
Sixty septoplasty patients (51.7% male, 48.3% female, aged 18 to 45 years) were randomly assigned to general anesthesia (GA) alone (control) (n = 30) or GA plus endoscopic SPGB (n = 30). Demographic data, duration of surgery, blood loss, postoperative visual analogue scale (VAS) pain scores (upon arrival at the postanesthesia care unit [PACU] and 2, 6, 12, and 24 hours after surgery), overall analgesic usage (end of 24 and 168 hours after surgery), overall satisfaction with the pain control (end of 24 and 168 hours after surgery), and complications (bleeding, nausea and vomiting, and visual disturbance) were recorded.
RESULTS
Pain scores upon arrival to the PACU and 2, 6, 12, and 24 hours after surgery were significantly lower in the SPGB group compared to the control group (p < 0.001). Moreover, the SPGB group had significantly lower analgesic requirements and higher satisfaction scores with their pain control at the end of 24 and 168 hours after surgery compared to the control group (p < 0.001). The 2 groups significantly differed in terms of intraoperative blood loss (p = 0.024), and surgery time was longer in the SPGB group compared to the control group (p < 0.001).
CONCLUSION
SPGB with bupivacaine is a safe and effective method to reduce pain after septoplasty, and it is a cost-effective alternative to high doses of analgesics.",2019,"The 2 groups significantly differed in terms of intraoperative blood loss (p = 0.024), and surgery time was longer in the SPGB group compared to the control group (p < 0.001).
","['patients undergoing septoplasty', 'postoperative pain after septal surgery', 'Sixty septoplasty patients (51.7% male, 48.3% female, aged 18 to 45 years']","['general anesthesia (GA) alone (control) (n = 30) or GA plus endoscopic SPGB', 'bilateral endoscopic sphenopalatine ganglion block (SPGB', 'endoscopic sphenopalatine ganglion block', 'bupivacaine', 'SPGB']","['Demographic data, duration of surgery, blood loss, postoperative visual analogue scale (VAS) pain scores (upon arrival at the postanesthesia care unit [PACU] and 2, 6, 12, and 24 hours after surgery), overall analgesic usage', 'pain', 'overall satisfaction with the pain control', 'intraoperative blood loss', 'Pain scores', 'complications (bleeding, nausea and vomiting, and visual disturbance', 'surgery time', 'analgesic requirements and higher satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0394799', 'cui_str': 'Pterygopalatine Ganglion Block'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0547030', 'cui_str': 'Visual disturbance (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0683503,"The 2 groups significantly differed in terms of intraoperative blood loss (p = 0.024), and surgery time was longer in the SPGB group compared to the control group (p < 0.001).
","[{'ForeName': 'Nur Yücel', 'Initials': 'NY', 'LastName': 'Ekici', 'Affiliation': 'Department of Otorhinolaryngology, Adana City Training and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Alagöz', 'Affiliation': 'Department of Otorhinolaryngology, Adana City Training and Research Hospital, Adana, Turkey.'}]",International forum of allergy & rhinology,['10.1002/alr.22411']
961,31925809,Effects of statin therapy and exercise on postprandial triglycerides in overweight individuals with hypercholesterolaemia.,"AIMS
To determine the effects of statins on postprandial lipaemia (PPL) and to study if exercise could enhance statin actions.
METHODS
Ten hypercholesteraemic (blood cholesterol 204 ± 36 mg dL -1 ; low-density lipoprotein-cholesterol 129 ± 32 36 mg dL -1 ) overweight (body mass index 30 ± 4 kg m -2 ), metabolic syndrome individuals chronically medicated with statins (>6 months) underwent 5-hour PPL tests in 4 occasions in a randomized order: (i) substituting their habitual statin medication by placebo for 96 hours (PLAC trial); (ii) taking their habitual statin medicine (STA trial); (iii) placebo combined with a bout of intense aerobic exercise (EXER+PLAC trial); and (iv) combining exercise and statin medicine (EXER+STA trial).
RESULTS
Before the fat meal, statin withdrawal (i.e. PLAC and EXER+PLAC) increased blood triglycerides (TG; 24%), low-density lipoprotein-cholesterol (31%) and total cholesterol (19%; all P < .05) evidencing treatment compliance. After the meal, statin withdrawal increased 5-hour postprandial TG (PPTG) compared to its matched trials (94% higher PLAC vs STA and 45% higher EXER+PLAC vs EXER+STA; P < .05). EXER+PLAC trial did not lower PPTG below PLAC (i.e. incremental AUC of 609 ± 152 vs 826 ± 190 mg dL -1 5 h; P = .09). Adding exercise to statin did not result in larger reductions in PPTG (i.e. EXER+STA vs STA incremental area under the curve of 421 ± 87 vs 421 ± 84 mg dL -1 5 h; P = .99).
CONCLUSION
In hypercholesteraemic metabolic syndrome individuals, chronic statin therapy blunts the elevations in TG after a fat meal (i.e. incremental area under the curve of PPTG) reducing the cardiovascular risk associated to their atherogenic dyslipidaemia. However, a single bout of intense aerobic exercise before the high fat meal, does not reduce PPTG but also does not interfere with the effects of statin treatment.",2020,"EXER+PLAC trial did not lower PPTG below PLAC (i.e., incremental AUC of 609±152 vs 826±190","[' LDL-c 129±32 36 mg·dL -1 ) overweight (BMI 30±4 kg·m -2 ), metabolic syndrome (MetS) individuals chronically medicated with statins (> 6 months', 'overweight individuals with hypercholesterolemia', 'Ten hypercholesterolemic (blood cholesterol', '204±36']","['habitual statin medication by placebo', 'placebo combined with a bout of intense aerobic exercise (EXER+PLAC trial) and d) combining exercise and statin medicine (EXER+STA trial', 'fat meal', 'EXER+PLAC', 'statins therapy and exercise', 'statins']","['postprandial triglycerides', 'blood triglycerides', 'total cholesterol', 'statin withdrawal increased 5-h postprandial TG (PPTG', 'LDL-c', 'mg·dL -1']","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",10.0,0.111124,"EXER+PLAC trial did not lower PPTG below PLAC (i.e., incremental AUC of 609±152 vs 826±190","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}]",British journal of clinical pharmacology,['10.1111/bcp.14217']
962,31913324,Impact of an integrated mother-preterm infant intervention on birth hospitalization charges.,"OBJECTIVE
To examine whether the H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) intervention reduced birth hospitalization charges yielding net savings after adjusting for intervention costs.
STUDY DESIGN
One hundred and twenty-one mother-preterm infant dyads randomized to H-HOPE or a control group had birth hospitalization data. Neonatal intensive care unit costs were based on billing charges. Linear regression, propensity scoring and regression analyses were used to describe charge differences.
RESULTS
Mean H-HOPE charges were $10,185 lower than controls (p = 0.012). Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants. Cost savings increased as hospital charges increased. The mean intervention cost was $680 per infant.
CONCLUSIONS
Lower birth hospitalization charges and the net cost savings of H-HOPE infants support implementation of H-HOPE as the standard of care for preterm infants.",2020,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[""Preterm Infant's Environment"", 'One hundred and twenty-one mother-preterm infant dyads randomized to', 'preterm infants']","['H-HOPE', 'H-HOPE (Hospital to Home', 'integrated mother-preterm infant intervention']","['birth hospitalization data', 'mean intervention cost', 'Mean H-HOPE charges', 'birth hospitalization charges', 'Cost savings']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}]",121.0,0.0351533,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[{'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Vonderheid', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA. vonde@uic.edu.'}, {'ForeName': 'Chang G', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rankin', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Norr', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'White-Traut', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0567-7']
963,31544290,Novel thulium fiber laser for endoscopic enucleation of the prostate: A prospective comparison with conventional transurethral resection of the prostate.,"OBJECTIVE
To compare the efficacy and safety of a novel thulium fiber laser for endoscopic enucleation of the prostate with monopolar transurethral resection of the prostate in patients with smaller glands (<80 cc).
METHODS
A total of 51 patients underwent thulium fiber laser enucleation of the prostate, and 52 patients underwent monopolar transurethral resection of the prostate. All patients were assessed preoperatively, and at 3, 6, and 12 months postoperatively (International Prostate Symptom Score, maximum urine flow rate, International Prostate Symptom Score-quality of life). Preoperative prostate volumes and prostate-specific antigen levels were comparable (P = 0.543 and P = 0.078, respectively). The complications were graded according to the Clavien classification.
RESULTS
Mean surgery time was longer in the thulium fiber laser enucleation of the prostate group (46.6 ± 10.2 vs 39.9 ± 8.6 min, P < 0.001), while catheterization and hospital stay were greater in the transurethral resection of the prostate group (P < 0.001). At 12 months, there were no differences in functional outcomes (International Prostate Symptom Score, maximum urine flow rate). Despite comparable prostate volumes at 12 months (P = 0.864), the prostate-specific antigen level in the thulium fiber laser enucleation of the prostate group (0.5 ± 0.5 ng/mL) was lower than in the transurethral resection of the prostate group (1.1 ± 1.0 ng/mL; P < 0.001). Hemoglobin and serum sodium decrease was lower in the thulium fiber laser enucleation of the prostate group (1.01 ± 0.4 g/dL and 1.1 ± 1.1 mmol/L) than in the transurethral resection of the prostate group (1.8 ± 0.8 g/dL and 4.1 ± 1.1 mmol/L; P < 0.001). Urinary incontinence rates at 12 months were comparable (P = 0.316).
CONCLUSIONS
Thulium fiber laser enucleation of the prostate with novel thulium fiber laser in patients with smaller prostate glands (<80 cc) is comparable to transurethral resection of the prostate in voiding parameters improvement and complication rates. At the same time, the technique allows for a more substantial prostate-specific antigen decrease, indicating more complete removal of adenoma.",2019,"< 0.001), while catheterization and hospital stay were greater in the transurethral resection of the prostate group (P < 0.001).","['patients with smaller glands (<80\xa0cc', '51 patients underwent', 'endoscopic enucleation of the prostate']","['Novel thulium fiber laser', 'conventional transurethral resection of the prostate', 'monopolar transurethral resection of the prostate', 'monopolar transurethral resection', 'novel thulium fiber laser', 'thulium fiber laser enucleation', 'Thulium fiber laser enucleation']","['functional outcomes (International Prostate Symptom Score, maximum urine flow rate', 'efficacy and safety', 'Urinary incontinence rates', 'Preoperative prostate volumes and prostate-specific antigen levels', 'catheterization and hospital stay', 'prostate-specific antigen level', 'Hemoglobin and serum sodium decrease', 'International Prostate Symptom Score, maximum urine flow rate, International Prostate Symptom Score-quality of life', 'Mean surgery time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0042037'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4048754', 'cui_str': 'Serum sodium decreased'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0185111,"< 0.001), while catheterization and hospital stay were greater in the transurethral resection of the prostate group (P < 0.001).","[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Enikeev', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Netsch', 'Affiliation': 'Department of Urology, Asklepios Hospital Barmbek, Hamburg, Germany.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Rapoport', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Magomed', 'Initials': 'M', 'LastName': 'Gazimiev', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Laukhtina', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Olesya', 'Initials': 'O', 'LastName': 'Snurnitsyna', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Alekseeva', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'Department of Urology, Asklepios Hospital Barmbek, Hamburg, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Taratkin', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Glybochko', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14115']
964,31413177,PARP1 Inhibition Radiosensitizes Models of Inflammatory Breast Cancer to Ionizing Radiation.,"Sustained locoregional control of disease is a significant issue in patients with inflammatory breast cancer (IBC), with local control rates of 80% or less at 5 years. Given the unsatisfactory outcomes for these patients, there is a clear need for intensification of local therapy, including radiation. Inhibition of the DNA repair protein PARP1 has had little efficacy as a single agent in breast cancer outside of studies restricted to patients with BRCA mutations; however, PARP1 inhibition (PARPi) may lead to the radiosensitization of aggressive tumor types. Thus, this study investigates inhibition of PARP1 as a novel and promising radiosensitization strategy in IBC. In multiple existing IBC models (SUM-149, SUM-190, MDA-IBC-3), PARPi (AZD2281-olaparib and ABT-888-veliparib) had limited single-agent efficacy (IC 50 > 10 μmol/L) in proliferation assays. Despite limited single-agent efficacy, submicromolar concentrations of AZD2281 in combination with RT led to significant radiosensitization (rER 1.12-1.76). This effect was partially dependent on BRCA1 mutational status. Radiosensitization was due, at least in part, to delayed resolution of double strand DNA breaks as measured by multiple assays. Using a SUM-190 xenograft model in vivo , the combination of PARPi and RT significantly delays tumor doubling and tripling times compared with PARPi or RT alone with limited toxicity. This study demonstrates that PARPi improves the effectiveness of radiotherapy in IBC models and provides the preclinical rationale for the opening phase II randomized trial of RT ± PARPi in women with IBC (SWOG 1706, NCT03598257).",2019,"Inhibition of the DNA repair protein poly adenosine diphosphate-ribose polymerase 1 (PARP1) has had little efficacy as a single agent in breast cancer outside of studies restricted to patients with BRCA mutations; however, PARP1 inhibition (PARPi) may lead to the radiosensitization of aggressive tumor types.","['patients with inflammatory breast cancer (IBC), with local control rates of 80% or less at 5 years']","['radiotherapy', 'PARPi']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278601', 'cui_str': 'Inflammatory Breast Cancer'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],,0.0362699,"Inhibition of the DNA repair protein poly adenosine diphosphate-ribose polymerase 1 (PARP1) has had little efficacy as a single agent in breast cancer outside of studies restricted to patients with BRCA mutations; however, PARP1 inhibition (PARPi) may lead to the radiosensitization of aggressive tumor types.","[{'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Michmerhuizen', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Pesch', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Moubadder', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Chandler', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Wilder-Romans', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Meleah', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Olsen', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Dafydd G', 'Initials': 'DG', 'LastName': 'Thomas', 'Affiliation': 'Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hirsh', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Cassandra L', 'Initials': 'CL', 'LastName': 'Ritter', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Meilan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Nyati', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Jagsi', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Speers', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan. cspeers@med.umich.edu.'}]",Molecular cancer therapeutics,['10.1158/1535-7163.MCT-19-0520']
965,31033133,"Polar lipids from wheat extract oil improve skin damages induced by aging: Evidence from a randomized, placebo-controlled clinical trial in women and an ex vivo study on human skin explant.","BACKGROUND
Polar lipids from wheat (Triticum vulgare/aestivum) extract oil (WEO) are known to improve skin hydration.
AIMS
These studies aimed to assess WEO benefits on the skin appearance of middle-aged women.
METHODS
A double-blind, randomized, placebo-controlled clinical study was carried out on 64 healthy women, aged from 45 to 60 years, to investigate antiaging effects and benefits for the skin. The study lasted 20 weeks including 12 weeks of oral supplementation with WEO or placebo and 8 weeks of follow-up. Wrinkles in the ""crow's-feet"" area were evaluated by the Lemperle score. Skin hydration was measured using a corneometer, while roughness and radiance were determined by clinical scoring. Collagen content was quantified in human skin explants exposed to ultraviolet (UV) irradiations and treated with WEO or vehicle control.
RESULTS
Compared to the placebo group, the Lemperle score was significantly reduced in the WEO group between W0 and W8 to reach a clinically significant 1 grade at W12. Facial hydration was significantly improved in the WEO group from W0 to W12, whereas leg hydration was significantly increased after 4 weeks and lasted throughout the supplementation period. Skin roughness and radiance were also significantly improved from W0 to W8 in the WEO group compared to placebo group. A higher collagen content was measured in the UV-irradiated skin explants treated with WEO compared to the untreated ones.
CONCLUSION
These results confirmed the moisturizing effect of WEO and, for the first time, revealed its potential antiaging properties.",2019,Skin roughness and radiance were also significantly improved from W0 to W8 in the WEO group compared to placebo group.,"['middle-aged women', 'women and an ex vivo study on human skin explant', '64 healthy women, aged from 45 to 60\xa0years']","['placebo', 'Polar lipids from wheat extract oil', 'ultraviolet (UV) irradiations and treated with WEO or vehicle control', 'Polar lipids from wheat (Triticum vulgare/aestivum) extract oil (WEO', 'oral supplementation with WEO or placebo']","['Skin hydration', 'Skin roughness and radiance', 'leg hydration', 'Facial hydration', 'Lemperle score', 'collagen content', 'Collagen content']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1123020', 'cui_str': 'Triticum vulgare'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",64.0,0.197985,Skin roughness and radiance were also significantly improved from W0 to W8 in the WEO group compared to placebo group.,"[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Boisnic', 'Affiliation': 'Gredeco, Paris, France.'}, {'ForeName': 'Mayoura', 'Initials': 'M', 'LastName': 'Keophiphath', 'Affiliation': 'D.I.V.A. Expertise, Toulouse, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Serandour', 'Affiliation': 'SLB Pharma, Rennes, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Branchet', 'Affiliation': 'Gredeco, Paris, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Le Breton', 'Affiliation': 'SLB Pharma, Rennes, France.'}, {'ForeName': 'Irène', 'Initials': 'I', 'LastName': 'Lamour', 'Affiliation': 'Robertet Group, Grasse, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Gaillard', 'Affiliation': 'Robertet Group, Grasse, France.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12967']
966,31862738,Effect of a simple intervention on hand hygiene related diseases in preschools in South Africa: research protocol for an intervention study.,"INTRODUCTION
Hand hygiene (HH) related illnesses such as diarrhoea and respiratory diseases, contribute to the burden of disease and are included in the top five causes of mortality in children under 5 years in South Africa. Children attending preschools are more susceptible to these infections due to the higher number of children in preschools. HH interventions have shown to reduce HH-related diseases by improving HH practices. In South Africa, there are no documented HH interventions or studies in children under 5 years. The purpose of the study is to determine whether an HH intervention can reduce HH-related diseases among 4-5-year-old preschool children and to improve HH practices in these children, their caregivers and their parents.
METHODOLOGY AND ANALYSIS
This is a protocol for a controlled intervention study to be conducted at preschools in Kempton Park, City of Ekurhuleni, Gauteng, South Africa. Preschools will be randomly distributed into control and experimental groups (n=70). The intervention includes interactive simulation learning, educational emails and education and poster reminders obtained from the WHO and the Global Handwashing Day website. Data collection, including the intervention, will take place during the calendar year as this coincides with the school year. Data will be analysed both preintervention and postintervention in the experimental group as well as between the experimental and control group. Data collected by means of questionnaires, observations, disease registers, hygiene inspections, semi-structured interviews and hand swabs will be analysed to determine these outcomes.
ETHICS AND DISSEMINATION
Permission has been obtained from the University of Johannesburg Ethics Committee and Ministerial Consent for Non-Therapeutic Research on Minors from the Department of Health National Ethics Research Council. Permissions for use of copyright protected materials has been obtained. Results of the study will be disseminated through peer-reviewed publications, and feedback within relevant structures through conference proceedings.",2019,Data will be analysed both preintervention and postintervention in the experimental group as well as between the experimental and control group.,"['Children attending preschools', 'children under 5 years in South Africa', 'hand hygiene related diseases in preschools in South Africa', '4-5-year-old preschool children and to improve HH practices in these children, their caregivers and their parents', 'conducted at preschools in Kempton Park, City of Ekurhuleni, Gauteng, South Africa']","['interactive simulation learning, educational emails and education and poster reminders obtained from the WHO and the Global Handwashing Day website', 'HH interventions', 'HH intervention', 'simple intervention']",['HH-related diseases'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376675', 'cui_str': 'Poster'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.036519,Data will be analysed both preintervention and postintervention in the experimental group as well as between the experimental and control group.,"[{'ForeName': 'Samantha Louise', 'Initials': 'SL', 'LastName': 'Lange', 'Affiliation': 'Water and Health Research Centre, Faculty of Health Sciences, University of Johannesburg, Auckland Park, South Africa samlange18@gmail.com.'}, {'ForeName': 'Tobias George', 'Initials': 'TG', 'LastName': 'Barnard', 'Affiliation': 'Water and Health Research Centre, Faculty of Health Sciences, University of Johannesburg, Auckland Park, South Africa.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Naicker', 'Affiliation': 'Environmental Health, Faculty of Health Sciences, University of Johannesburg, Auckland Park, South Africa.'}]",BMJ open,['10.1136/bmjopen-2019-030656']
967,31880796,Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial.,"Importance
Insomnia disorder is prevalent and associated with health risks in older adults; however, efficacy and safety issues with existing treatments create significant unmet needs in this patient population.
Objective
To compare treatment with the orexin receptor antagonist lemborexant with placebo and zolpidem tartrate extended release in participants with insomnia disorder.
Design, Setting, and Participants
The Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) clinical trial was a global randomized double-blind parallel-group placebo-controlled active-comparator phase 3 study conducted at 67 sites in North America and Europe from May 31, 2016, to January 30, 2018. Data analyses were conducted from January 31, 2018, to September 10, 2018. Participants were 55 years and older with insomnia disorder characterized by reported sleep maintenance difficulties and confirmed by sleep history, sleep diary, and polysomnography. Participants could have also had sleep onset difficulties.
Interventions
Participants received placebo, zolpidem tartrate extended release (6.25 mg), or lemborexant (5 mg or 10 mg) for 1 month at bedtime.
Main Outcomes and Measures
Paired polysomnograms were collected at baseline, the first 2 nights, and the last 2 nights of treatment. The primary end point was the change from baseline in latency to persistent sleep for lemborexant therapy vs placebo. Key secondary end points were changes from baseline in sleep efficiency and wake-after-sleep onset compared with placebo, and wake-after-sleep onset in the second half of the night compared with zolpidem therapy.
Results
Among 1006 participants randomized (placebo, n = 208; zolpidem, n = 263; lemborexant 5 mg, n = 266; and lemborexant 10 mg, n = 269), 869 (86.4%) were women and the median age was 63 years (range, 55-88 years). Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001). For nights 29 and 30, as measured using polysomnography, the mean change from baseline in sleep efficiency (LSM treatment difference vs placebo for lemborexant 5 mg, 7.1%; 95% CI, 5.6%-8.5%; P < .001 and for lemborexant 10 mg, 8.0%; 95% CI, 6.6%-9.5%; P < .001) and wake-after-sleep onset (least squares mean treatment ratio vs placebo for lemborexant 5 mg, -24.0 min; 95% CI, -30.0 to -18.0 min; P < .001 and for lemborexant 10 mg, -25.4 min; 95% CI, -31.4 to -19.3 min; P < .001) were significantly greater for both doses of lemborexant therapy compared with placebo. Also, for nights 29 and 30, wake-after-sleep onset in the second half of the night (least squares mean treatment difference vs zolpidem for lemborexant 5 mg, -6.7 min; 95% CI, -11.2 to -2.2 min; P = .004 and for lemborexant 10 mg, -8.0 min; 95% CI, -12.5 to -3.5 min; P < .001) was significantly greater for both doses of lemborexant therapy compared with zolpidem therapy measured using polysomnography. Six participants (4 in the zolpidem group and 2 in the lemborexant 5 mg group) reported serious adverse events; none were treatment-related. Other adverse events were mostly mild or moderate in severity.
Conclusions and Relevance
In this randomized clinical trial, lemborexant therapy significantly improved both sleep onset and sleep maintenance, including in the second half of the night, compared with both placebo and zolpidem measured objectively using polysomnography. Lemborexant therapy was well tolerated.
Trial Registrations
ClinicalTrials.gov identifier: NCT02783729; EudraCT identifier: 2015-001463-39.",2019,"Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001).","['phase 3 study conducted at 67 sites in North America and Europe from May 31, 2016, to January 30, 2018', '1006 participants randomized', 'older adults', '10 mg, n\u2009=\u2009269), 869 (86.4%) were women and the median age was 63 years (range, 55-88 years', 'Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1', 'Older Adults With Insomnia Disorder', 'participants with insomnia disorder', 'Participants were 55 years and older with insomnia disorder characterized by reported sleep maintenance difficulties and confirmed by sleep history, sleep diary, and polysomnography']","['zolpidem', 'placebo and zolpidem', 'orexin receptor antagonist lemborexant with placebo and zolpidem tartrate', 'Lemborexant With Placebo', 'Zolpidem Tartrate', 'placebo, zolpidem tartrate extended release (6.25 mg), or lemborexant', 'zolpidem, n\u2009=\u2009263; lemborexant 5 mg, n\u2009=\u2009266; and lemborexant', 'Lemborexant therapy', 'placebo', 'Lemborexant', 'placebo-controlled active-comparator', 'lemborexant therapy vs placebo', 'lemborexant therapy']","['serious adverse events', 'sleep efficiency', 'objective sleep onset', 'sleep onset difficulties', 'sleep efficiency and wake-after-sleep onset compared with placebo, and wake-after-sleep onset', 'sleep onset and sleep maintenance', 'latency to persistent sleep', 'tolerated']","[{'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]","[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019081', 'cui_str': 'Orexin Receptor Blockers'}, {'cui': 'C0724725', 'cui_str': 'Zolpidem tartrate'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4517821', 'cui_str': '6.25'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",1006.0,0.534433,"Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001).","[{'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'NeuroTrials Research, Atlanta, Georgia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Murphy', 'Affiliation': 'ICON, North Wales, Pennsylvania.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mayleben', 'Affiliation': 'Community Research, Cincinnati, Ohio.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Dhadda', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'LoPresti', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18254']
968,31611264,Dimethyl fumarate decreases neurofilament light chain in CSF and blood of treatment naïve relapsing MS patients.,"OBJECTIVES
In a prospective phase IV trial of the first-line oral treatment dimethyl fumarate (DMF), we examined dynamics of neurofilament light (NFL) chain in serum, plasma and cerebrospinal fluid (CSF) samples collected over 12 months from relapsing-remitting multiple sclerosis (RRMS) patients. NFL changes were related to disease activity.
METHODS
We examined NFL levels by single-molecule array in 88 CSF, 348 plasma and 131 sera from treatment-naïve RRMS patients (n=52), healthy controls (n=23) and a placebo group matched by age, sex and NFL (n=52). Plasma/sera were collected at baseline, and 1, 3, 6 and 12 months after DMF. CSF samples were collected at baseline and 12 months after DMF.
RESULTS
NFL concentration in CSF, plasma and serum correlated highly (p<0.0001 for all), but plasma levels were only 76.9% of paired serum concentration. After 12 months of DMF treatment, NFL concentration decreased by 73%, 69% and 55% in the CSF, serum and plasma (p<0.0001, respectively). Significant reduction in blood was observed after 6 and 12 months treatment compared with baseline (p<0.01 and p<0.0001, respectively) and to placebo (p<0.0001). Patients with NFL above the 807.5 pg/mL cut-off in CSF had 5.0-times relative risk of disease activity (p<0.001).
CONCLUSIONS
This study provides Class II evidence that first-line DMF reduces NFL in both blood and CSF after 6 months and normalises CSF levels in 73% of patients. High NFL concentration in CSF after a year reflected disease activity. NFL levels were higher in serum than in plasma, which should be considered when NFL is used as a biomarker.",2019,"After 12 months of DMF treatment, NFL concentration decreased by 73%, 69% and 55% in the CSF, serum and plasma (p<0.0001, respectively).","['88 CSF, 348 plasma and 131 sera from treatment-naïve RRMS patients (n=52), healthy controls (n=23) and a placebo group matched by age, sex and NFL (n=52', 'relapsing-remitting multiple sclerosis (RRMS) patients']","['placebo', 'Dimethyl fumarate', 'first-line oral treatment dimethyl fumarate (DMF']","['Plasma/sera', 'blood', 'NFL concentration in CSF, plasma and serum', 'neurofilament light (NFL) chain in serum, plasma and cerebrospinal fluid (CSF) samples', 'CSF samples', 'normalises CSF levels', 'plasma levels', 'NFL concentration', 'NFL levels']","[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005768'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C1292530', 'cui_str': 'Cerebrospinal fluid specimen'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",88.0,0.0387063,"After 12 months of DMF treatment, NFL concentration decreased by 73%, 69% and 55% in the CSF, serum and plasma (p<0.0001, respectively).","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Sejbaek', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark Tobias.Sejbaek.Mathiesen@rsyd.dk.'}, {'ForeName': 'Helle Hvilsted', 'Initials': 'HH', 'LastName': 'Nielsen', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Penner', 'Affiliation': 'Value Based Medicine, Biogen Idec Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Plavina', 'Affiliation': 'Value Based Medicine, Biogen Idec Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Mendoza', 'Affiliation': 'Value Based Medicine, Biogen Idec Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nellie Anne', 'Initials': 'NA', 'LastName': 'Martin', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Maria Louise', 'Initials': 'ML', 'LastName': 'Elkjaer', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Mads Henrik', 'Initials': 'MH', 'LastName': 'Ravnborg', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Illes', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-321321']
969,31899529,Effectiveness of Virtual vs In-Person Inhaler Education for Hospitalized Patients With Obstructive Lung Disease: A Randomized Clinical Trial.,"Importance
Many patients who are hospitalized cannot use inhalers correctly, yet education for their use is often not provided. To address the need for an effective intervention feasible for wide-scale implementation, a virtual teach-to-goal intervention was developed to provide tailored patient-directed education using adaptive learning technology.
Objective
To assess whether the virtual teach-to-goal intervention is noninferior to an in-person teach-to-goal intervention for improving inhaler technique.
Design, Setting, and Participants
An equivalence and noninferiority randomized clinical trial took place from January 13, 2016, through September 20, 2017, with analyses conducted between October 25, 2017, and September 23, 2019. Adult inpatients with asthma or chronic obstructive pulmonary disease (COPD) admitted to general inpatient wards were eligible. Enrolled participants were randomized to virtual (n = 61) or in-person (n = 60) educational interventions. Investigators and research assistants were masked to interventions. Initial enrollment, study assessments, and delivery of the educational intervention occurred in the hospital; participants returned at 30 days for a follow-up research visit.
Interventions
Virtual education was a module delivered via handheld tablet with self-assessment questions before demonstration, narrated video demonstration of the correct technique, and self-assessment questions after demonstration; up to 3 rounds were repeated as needed. In-person education participants received iterative rounds of inhaler technique assessment and education by trained staff.
Main Outcomes and Measures
Noninferiority testing of whether virtual vs in-person education achieved an equal percentage with correct inhaler technique after education (>9 of 12 steps correct) against an a priori noninferiority limit of -10%; logistic regression models were used to adjust for differences in baseline technique and health literacy.
Results
Among 118 participants (59 in each group), most were black (114 [97%]) and female (76 [64%]), with a mean (SD) age of 54.5 (13.0) years. Correct technique increased similarly before vs after education in virtual (67%; range, 2%-69%) and in-person (66%; range, 17% to 83%) groups, although the difference after intervention exceeded the noninferiority limit (-14%; 95% CI lower bound, -26%). When adjusting for baseline inhaler technique, the difference was equivalent to the noninferiority limit (-10%; 95% CI lower bound, -22%).
Conclusions and Relevance
The findings suggest that patient-directed virtual education similarly improved the percentage of participants with correct technique compared with in-person education. Future work should confirm whether virtual teach-to-goal education is noninferior to in-person education and whether it is associated with long-term skills retention, medication adherence, and improved health outcomes.
Trial Registration
ClinicalTrials.gov identifier: NCT02611531.",2020,"Correct technique increased similarly before vs after education in virtual (67%; range, 2%-69%) and in-person (66%; range, 17% to 83%) groups, although the difference after intervention exceeded the noninferiority limit (-14%; 95% CI lower bound, -26%).","['Hospitalized Patients With Obstructive Lung Disease', '118 participants (59 in each group', 'Adult inpatients with asthma or chronic obstructive pulmonary disease (COPD) admitted to general inpatient wards were eligible', 'January 13, 2016, through September 20, 2017, with analyses conducted between October 25, 2017, and September 23, 2019']","['person (n\u2009=\u200960) educational interventions', 'Virtual vs In-Person Inhaler Education']","['Correct technique', 'noninferiority limit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600260', 'cui_str': 'Obstructive Pulmonary Diseases'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",118.0,0.201069,"Correct technique increased similarly before vs after education in virtual (67%; range, 2%-69%) and in-person (66%; range, 17% to 83%) groups, although the difference after intervention exceeded the noninferiority limit (-14%; 95% CI lower bound, -26%).","[{'ForeName': 'Valerie G', 'Initials': 'VG', 'LastName': 'Press', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Vineet M', 'Initials': 'VM', 'LastName': 'Arora', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Kelly', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Carey', 'Affiliation': 'Section of Pulmonary and Critical Care Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Steve R', 'Initials': 'SR', 'LastName': 'White', 'Affiliation': 'Section of Pulmonary and Critical Care Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, University of Chicago, Chicago, Illinois.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18205']
970,31860598,Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study.,"BACKGROUND
Tracheal intubation using a double-lumen endobronchial tube (DLT) causes postoperative sore throat.
OBJECTIVE
To determine the effect of two-handed jaw thrust on postoperative sore throat in patients requiring insertion of a DLT.
DESIGN
A randomised study.
SETTING
A tertiary teaching hospital from December 2017 to May 2018.
PATIENTS
One-hundred and six patients undergoing one-lung anaesthesia.
INTERVENTIONS
Patients were allocated to one of two groups (n=53 each). In the jaw thrust group, the two-handed jaw thrust manoeuvre was applied at intubation and advancement of the DLT. In the control group, conventional intubation with a sham jaw thrust was performed.
MAIN OUTCOME MEASURES
Incidence of sore throat at 1, 6 and 24 h postoperatively.
RESULTS
The incidence of sore throat at 6 h postoperatively was higher in the control group than in the jaw thrust group [31 (59%) vs. 14 (26%), risk ratio (95% confidence interval) 0.45 (0.27 to 0.75), P < 0.01]. The overall incidence of sore throat was higher in the control group than in the jaw thrust group [35 (66%) vs. 18 (34%), risk ratio (95% confidence interval) 0.51 (0.34 to 0.78), P < 0.01].
CONCLUSION
The jaw thrust manoeuvre can reduce the incidence of sore throat in patients undergoing DLT insertion for one-lung ventilation.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03331809.",2020,"The incidence of sore throat at 6 h postoperatively was higher in the control group than in the jaw thrust group [31 (59%) vs. 14 (26%), risk ratio (95% confidence interval) 0.45 (0.27 to 0.75), P < 0.01].","['A tertiary teaching hospital from December 2017 to May 2018', 'patients undergoing double-lumen endobronchial intubation', 'One-hundred and six patients undergoing one-lung anaesthesia', 'patients requiring insertion of a DLT']","['placebo', 'conventional intubation', 'Tracheal intubation using a double-lumen endobronchial tube (DLT']","['overall incidence of sore throat', 'Incidence of sore throat at 1, 6 and 24\u200ah postoperatively', 'risk ratio', 'postoperative sore throat', 'incidence of sore throat']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0396632', 'cui_str': 'Endobronchial intubation (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1275736', 'cui_str': 'Endobronchial tube'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",106.0,0.333425,"The incidence of sore throat at 6 h postoperatively was higher in the control group than in the jaw thrust group [31 (59%) vs. 14 (26%), risk ratio (95% confidence interval) 0.45 (0.27 to 0.75), P < 0.01].","[{'ForeName': 'Jeong J', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul (JJP, HH, SZY, H-JL, DYG, JEC, H-CK) and Department of Anaesthesiology and Pain Medicine, College of Medicine, Keimyung University Dongsan Medical Centre, Daegu, South Korea (JL, JP).'}, {'ForeName': 'Hyub', 'Initials': 'H', 'LastName': 'Huh', 'Affiliation': ''}, {'ForeName': 'Seung Z', 'Initials': 'SZ', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Hye-Ja', 'Initials': 'HJ', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Doo Y', 'Initials': 'DY', 'LastName': 'Go', 'Affiliation': ''}, {'ForeName': 'Jang E', 'Initials': 'JE', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jihoon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyun-Chang', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001149']
971,31881954,"Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial - DAiP study.","BACKGROUND
Compulsory admission to psychiatric hospital is rising despite serious ethical concerns. Among measures to reduce compulsory admissions, Psychiatric Advance Directives (PAD) are the most promising, with intensive PAD (i.e. facilitated and shared) being the most effective. The aim of the study is to experiment Psychiatric Advance Directives in France.
METHODS
A multicentre randomized controlled trial and qualitative approach conducted from January 2019 to January 2021 with intent-to-treat analysis.
SETTING
Seven hospitals in three French cities: Lyon, Marseille, and Paris. Research assistants meet each participant at baseline, 6 months and 12 months after inclusion for face-to-face interviews.
PARTICIPANTS
400 persons with a DSM-5 diagnosis of bipolar I disorder (BP1), schizophrenia (SCZ), or schizoaffective disorders (SCZaff), compulsorily admitted to hospital within the last 12 months, with capacity to consent (MacCAT-CR), over 18 years old, and able to understand French.
INTERVENTIONS
The experimental group (PAD) (expected n = 200) is invited to fill in a document describing their crisis plan and their wishes in case of loss of mental capacity. Participants meet a facilitator, who is a peer support worker specially trained to help them. They are invited to nominate a healthcare agent, and to share the document with them, as well as with their psychiatrist. The Usual Care (UC) group (expected n = 200) receives routine care.
MAIN OUTCOMES AND MEASURES
The primary outcome is the rate of compulsory admissions to hospital during the 12-month follow-up. Secondary outcomes include quality of life (S-QoL18), satisfaction (CSQ8), therapeutic alliance (4-PAS), mental health symptoms (MCSI), awareness of disorders (SUMD), severity of disease (ICG), empowerment (ES), recovery (RAS), and overall costs.
DISCUSSION
Implication of peer support workers in PAD, potential barriers of supported-decision making, methodological issues of evaluating complex interventions, evidence-based policy making, and the importance of qualitative evaluation in the context of constraint are discussed.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03630822. Registered 14th August 2018.",2019,The experimental group (PAD) (expected n = 200) is invited to fill in a document describing their crisis plan and their wishes in case of loss of mental capacity.,"['Seven hospitals in three French cities', '400 persons with a DSM-5 diagnosis of bipolar I disorder (BP1), schizophrenia (SCZ), or schizoaffective disorders (SCZaff), compulsorily admitted to hospital within the last 12\u2009months, with capacity to consent (MacCAT-CR), over 18\u2009years old, and able to understand French', 'people living with schizophrenia, bipolar I disorders, or schizoaffective disorders', 'January 2019 to January 2021 with intent-to-treat analysis']","['Psychiatric advance directives', 'Usual Care (UC) group (expected n\xa0=\u2009200) receives routine care']","['quality of life (S-QoL18), satisfaction (CSQ8), therapeutic alliance (4-PAS), mental health symptoms (MCSI), awareness of disorders (SUMD), severity of disease (ICG), empowerment (ES), recovery (RAS), and overall costs', 'rate of compulsory admissions to hospital during the 12-month follow-up']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",400.0,0.0886275,The experimental group (PAD) (expected n = 200) is invited to fill in a document describing their crisis plan and their wishes in case of loss of mental capacity.,"[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Tinland', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France. aurelie.tinland@gmail.com.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Leclerc', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Loubière', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Mougeot', 'Affiliation': 'Centre Max Weber, UMR 5283 - Centre hospitalier Le Vinatier, Lyon, France.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Greacen', 'Affiliation': 'Mental Health and Social Sciences Research Unit, Paris Psychiatry and Neurosciences University Hospital Group, Paris, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Pontier', 'Affiliation': 'Department of Psychiatry, Sainte-Marguerite University Hospital, F-13009, Marseille, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Franck', 'Affiliation': 'Resource center of psychosocial rehabilitation, Centre hospitalier Le Vinatier, UMR 5229, CNRS & Université Claude Bernard Lyon 1, Université de Lyon, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lançon', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Boucekine', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}]",BMC psychiatry,['10.1186/s12888-019-2416-9']
972,31856771,Neurocognitive working mechanisms of the prevention of relapse in remitted recurrent depression (NEWPRIDE): protocol of a randomized controlled neuroimaging trial of preventive cognitive therapy.,"BACKGROUND
Major Depressive Disorder (MDD) is a psychiatric disorder with a highly recurrent character, making prevention of relapse an important clinical goal. Preventive Cognitive Therapy (PCT) has been proven effective in preventing relapse, though not for every patient. A better understanding of relapse vulnerability and working mechanisms of preventive treatment may inform effective personalized intervention strategies. Neurocognitive models of MDD suggest that abnormalities in prefrontal control over limbic emotion-processing areas during emotional processing and regulation are important in understanding relapse vulnerability. Whether changes in these neurocognitive abnormalities are induced by PCT and thus play an important role in mediating the risk for recurrent depression, is currently unclear. In the Neurocognitive Working Mechanisms of the Prevention of Relapse In Depression (NEWPRIDE) study, we aim to 1) study neurocognitive factors underpinning the vulnerability for relapse, 2) understand the neurocognitive working mechanisms of PCT, 3) predict longitudinal treatment effects based on pre-treatment neurocognitive characteristics, and 4) validate the pupil dilation response as a marker for prefrontal activity, reflecting emotion regulation capacity and therapy success.
METHODS
In this randomized controlled trial, 75 remitted recurrent MDD (rrMDD) patients will be included. Detailed clinical and cognitive measurements, fMRI scanning and pupillometry will be performed at baseline and three-month follow-up. In the interval, 50 rrMDD patients will be randomized to eight sessions of PCT and 25 rrMDD patients to a waiting list. At baseline, 25 healthy control participants will be additionally included to objectify cross-sectional residual neurocognitive abnormalities in rrMDD. After 18 months, clinical assessments of relapse status are performed to investigate which therapy induced changes predict relapse in the 50 patients allocated to PCT.
DISCUSSION
The present trial is the first to study the neurocognitive vulnerability factors underlying relapse and mediating relapse prevention, their value for predicting PCT success and whether pupil dilation acts as a valuable marker in this regard. Ultimately, a deeper understanding of relapse prevention could contribute to the development of better targeted preventive interventions.
TRIAL REGISTRATION
Trial registration: Netherlands Trial Register, August 18, 2015, trial number NL5219.",2019,"After 18 months, clinical assessments of relapse status are performed to investigate which therapy induced changes predict relapse in the 50 patients allocated to PCT.
","['25 healthy control participants', '75 remitted recurrent MDD (rrMDD) patients will be included', 'remitted recurrent depression (NEWPRIDE', '50 rrMDD patients']","['Preventive Cognitive Therapy (PCT', 'PCT', 'preventive cognitive therapy']","['pupil dilation response', 'Relapse']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression (disorder)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}]","[{'cui': 'C0026961', 'cui_str': 'Mydriasis'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",75.0,0.120185,"After 18 months, clinical assessments of relapse status are performed to investigate which therapy induced changes predict relapse in the 50 patients allocated to PCT.
","[{'ForeName': 'Rozemarijn S', 'Initials': 'RS', 'LastName': 'van Kleef', 'Affiliation': 'Cognitive Neuroscience Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 2, 9713 AW, Groningen, The Netherlands. r.s.van.kleef@umcg.nl.'}, {'ForeName': 'Claudi L H', 'Initials': 'CLH', 'LastName': 'Bockting', 'Affiliation': 'Department of Psychiatry and Urban Mental Health Institute, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'van Valen', 'Affiliation': 'Department of Geriatrics, Heidelberglaan 100, University Medical Center Utrecht, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Aleman', 'Affiliation': 'Cognitive Neuroscience Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 2, 9713 AW, Groningen, The Netherlands.'}, {'ForeName': 'Jan-Bernard C', 'Initials': 'JC', 'LastName': 'Marsman', 'Affiliation': 'Cognitive Neuroscience Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 2, 9713 AW, Groningen, The Netherlands.'}, {'ForeName': 'Marie-José', 'Initials': 'MJ', 'LastName': 'van Tol', 'Affiliation': 'Cognitive Neuroscience Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 2, 9713 AW, Groningen, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2384-0']
973,31856791,A web-based intervention to promote physical activity in adolescents and young adults with cystic fibrosis: protocol for a randomized controlled trial.,"BACKGROUND
Regular participation in physical activity by people with cystic fibrosis (CF) promotes positive clinical and health outcomes including reduced rate of decline in lung function, fewer hospitalizations and greater wellbeing. However adherence to exercise and activity programs is low, in part due to the substantial daily therapy burden for young people with CF. Strict infection control requirements limit the role of group exercise programs that are commonly used in other clinical groups. Investigation of methods to promote physical activity in this group has been limited. The Active Online Physical Activity in Cystic fibrosis Trial (ActionPACT) is an assessor-blinded, multi-centre, randomized controlled trial designed to compare the efficacy of a novel web-based program (ActivOnline) compared to usual care in promoting physical activity participation in adolescents and young adults with CF.
METHODS
Adolescents and young adults with CF will be recruited on discharge from hospital for a respiratory exacerbation. Participants randomized to the intervention group will have access to a web-based physical activity platform for the 12-week intervention period. ActivOnline allows users to track their physical activity, set goals, and self-monitor progress. All participants in both groups will be provided with standardised information regarding general physical activity recommendations for adolescents and young adults. Outcomes will be assessed by a blinded assessor at baseline, after completion of the intervention, and at 3-months followup. Healthcare utilization will be assessed at 12 months from intervention completion. The primary outcome is change in moderate-to-vigorous physical activity participation measured objectively by accelerometry. Secondary outcomes include aerobic fitness, health-related quality of life, anxiety and depression and sleep quality.
DISCUSSION
This trial will establish whether a web-based application can improve physical activity participation more effectively than usual care in the period following hospitalization for a respiratory exacerbation. The web-based application under investigation can be made readily and widely available to all individuals with CF, to support physical activity and exercise participation at a time and location of the user's choosing, regardless of microbiological status.
TRIAL REGISTRATION
Clinical trial registered on July 13, 2017 with the Australian and New Zealand Clinical Trials Register at (ACTRN12617001009303).",2019,"The web-based application under investigation can be made readily and widely available to all individuals with CF, to support physical activity and exercise participation at a time and location of the user's choosing, regardless of microbiological status.
","['Adolescents and young adults with CF will be recruited on discharge from hospital for a respiratory exacerbation', 'adolescents and young adults', 'adolescents and young adults with cystic fibrosis', 'July 13,\xa02017 with the Australian and New Zealand Clinical Trials Register at (ACTRN12617001009303', 'adolescents and young adults with CF', 'young people with CF', 'people with cystic fibrosis (CF']","['intervention group will have access to a web-based physical activity platform', 'standardised information regarding general physical activity recommendations', 'novel web-based program (ActivOnline', 'ActivOnline']","['aerobic fitness, health-related quality of life, anxiety and depression and sleep quality', 'Healthcare utilization', 'change in moderate-to-vigorous physical activity participation measured objectively by accelerometry']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}]",,0.140989,"The web-based application under investigation can be made readily and widely available to all individuals with CF, to support physical activity and exercise participation at a time and location of the user's choosing, regardless of microbiological status.
","[{'ForeName': 'Narelle S', 'Initials': 'NS', 'LastName': 'Cox', 'Affiliation': 'Monash University, La Trobe University and Institute for Breathing and Sleep, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne, Vic, 3004, Australia. narelle.cox@monash.edu.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Eldridge', 'Affiliation': 'La Trobe University, Level 4, The Alfred Centre, 99 Commercial Road, Melbourne, Vic, 3004, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rawlings', 'Affiliation': ""Monash Children's Hospital Monash University and La Trobe University , 246 Clayton Rd, Clayton, Vic, 3168, Australia.""}, {'ForeName': 'Julianna', 'Initials': 'J', 'LastName': 'Dreger', 'Affiliation': 'Monash University, La Trobe University and Alfred Health, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne, Vic 3004, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Corda', 'Affiliation': ""Physiotherapy Department Royal Children's Hospital, 50 Flemington Road Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hauser', 'Affiliation': 'Tasmanian Adult Cystic Fibrosis Unit, Royal Hobart Hospital, GPO Box 1061, Hobart, Tasmania, 7000, Australia.'}, {'ForeName': 'Brenda M', 'Initials': 'BM', 'LastName': 'Button', 'Affiliation': 'Departments of Physiotherapy and Respiratory Medicine Alfred Health and Department of Medicine, Nursing and Health Sciences, Monash University, 55 Commercial Road, Melbourne, Vic, 3004, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Adult Cystic Fibrosis Service, Westmead Hospital, PO Box 533, Wentworthville, NSW, 2145, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Nichols', 'Affiliation': ""Monash Children's Hospital/Monash Health CF Service, 246 Clayton Rd, Clayton, Victoria, 3168, Australia.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Middleton', 'Affiliation': ""Physiotherapy Department, Children's Hospital at Westmead, Hawkesbury Road, Westmead, NSW, 2145, Australia.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Ward', 'Affiliation': 'Physiotherapy and Cystic Fibrosis Services, 8E055.08, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000, Australia.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Dwyer', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, PO Box 170, Lidcombe, NSW, 1825, Australia.'}, {'ForeName': 'Owen W', 'Initials': 'OW', 'LastName': 'Tomlinson', 'Affiliation': ""Children's Health & Exercise Research Centre (CHERC), Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, Devon, EX1 2LU, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Denford', 'Affiliation': ""Children's Health & Exercise Research Centre (CHERC), Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, Devon, EX1 2LU, UK.""}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Barker', 'Affiliation': ""Children's Health & Exercise Research Centre (CHERC), Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, Devon, EX1 2LU, UK.""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Williams', 'Affiliation': ""Children's Health & Exercise Research Centre (CHERC), Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, Devon, EX1 2LU, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kingsley', 'Affiliation': 'La Trobe Rural Health School, La Trobe University, Bendigo, Vic, 3552, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Bundoora, Vic, 3086, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Monash University La Trobe University, Alfred Health and Institute for Breathing and Sleep, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne, Vic, 3004, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pulmonary medicine,['10.1186/s12890-019-0942-3']
974,31848158,Randomised controlled trial to evaluate the influence of mHealth and eHealth skin cancer prevention education among young organ transplant recipients: the HIPPOlino intervention study.,"OBJECTIVES
To determine whether a multicomponent sun protection intervention programme (mHealth) for young organ transplant recipients (OTR) leads to a higher increase of preventive knowledge and behavioural change than an e-learning education programme (eHealth).
DESIGN
Randomised controlled trial with one preintervention baseline survey and three follow-up surveys after 6 weeks, 6 and 12 months. Comparison of two different intervention schedules with a control group (CG).
SETTING
Multicomponent sun protection trainings in Germany, the Netherlands and Austria between June 2013 and September 2015.
PARTICIPANTS
137 OTRs (5-22 years of age, 61 females/76 males) participated in the study.
INTERVENTIONS
(A) Intervention group 1 (IG1): personal training with subsequent forwarding of individual ultraviolet index-dependent sun protection recommendations via short message service (SMS); (B) intervention group 2 (IG2): e-learning training without SMS; (C) CG: regular information letters, online training after 1 year.
OUTCOME MEASURES
Key questions were used to form a knowledge and a behavioural score. Behavioural strategies and knowledge were quantified through self-administered questionnaires.
RESULTS
Analyses 6 weeks after the intervention showed a higher knowledge increase in both IG compared with the CG (IG1 to CG: OR 12.64, 95% CI 4.20 to 38.20; IG2 to CG: OR 2.59, 95% CI 0.95 to 7.04). Sun protection behaviour improved slightly but not significantly in both IG (IG1 to CG: OR 2.56, 95% CI 0.93 to 7.00; IG2 to CG: OR 1.22, 95% CI 0.45 to 3.32). One year after the intervention, no behavioural changes were observed in either IG compared with the CG. IG1 but not IG2 still scored significantly higher in sun protection knowledge than the CG 1 year after intervention (IG1 to CG: OR 4.46, 95% CI 1.48 to 13.43; IG2 to CG: OR 1.41, 95% CI 0.51 to 3.93).
CONCLUSIONS
This multicomponent sun protection programme provides a promising strategy to increase sun protection knowledge and possibly also protective behaviour in young OTR.
TRIAL REGISTRATION NUMBER
DRKS00011393.",2019,"Sun protection behaviour improved slightly but not significantly in both IG (IG1 to CG: OR 2.56, 95% CI 0.93 to 7.00; IG2 to CG: OR 1.22, 95% CI 0.45 to 3.32).","['young organ transplant recipients', '137 OTRs (5-22 years of age, 61 females/76 males) participated in the study', 'Multicomponent sun protection trainings in Germany, the Netherlands and Austria between June 2013 and September 2015', 'young organ transplant recipients (OTR']","['control group (CG', 'A) Intervention group 1 (IG1', 'CG', 'personal training with subsequent forwarding of individual ultraviolet index-dependent sun protection recommendations via short message service (SMS); (B) intervention group 2 (IG2): e-learning training without SMS; (C) CG: regular information letters, online training after 1\u2009year', 'mHealth and eHealth skin cancer prevention education', 'multicomponent sun protection intervention programme (mHealth']","['behavioural changes', 'sun protection knowledge', 'preventive knowledge and behavioural change', 'Sun protection behaviour']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0524930', 'cui_str': 'Organ Grafts'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C3178909'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]",,0.0819758,"Sun protection behaviour improved slightly but not significantly in both IG (IG1 to CG: OR 2.56, 95% CI 0.93 to 7.00; IG2 to CG: OR 1.22, 95% CI 0.45 to 3.32).","[{'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Leibniz-Institut für Präventionsforschung und Epidemiologie-BIPS, Bremen, Germany boettcher@leibniz-bips.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Buck', 'Affiliation': 'Leibniz-Institut für Präventionsforschung und Epidemiologie-BIPS, Bremen, Germany.'}, {'ForeName': 'Hajo', 'Initials': 'H', 'LastName': 'Zeeb', 'Affiliation': 'Leibniz-Institut für Präventionsforschung und Epidemiologie-BIPS, Bremen, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Laschewski', 'Affiliation': 'Deutscher Wetterdienst, Freiburg, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Hauer', 'Affiliation': 'Bremen Cancer Society, Bremen, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Wagner', 'Affiliation': 'Department of Dermatology, Allergology and Phlebology, Klinikum Bremerhaven Reinkenheide, Bremerhaven, Germany.'}, {'ForeName': 'Michael Max', 'Initials': 'MM', 'LastName': 'Sachse', 'Affiliation': 'Department of Dermatology, Allergology and Phlebology, Klinikum Bremerhaven Reinkenheide, Bremerhaven, Germany.'}]",BMJ open,['10.1136/bmjopen-2018-028842']
975,31867656,Marketing Influences on Perceptions of Reduced Nicotine Content Cigarettes.,"INTRODUCTION
The Food and Drug Administration announced intent to reduce the nicotine content in cigarettes. There is limited evidence on how reduced nicotine content cigarette (RNC) marketing affects product beliefs and use, and research on this is needed to inform regulations.
METHODS
In an online experiment, 426 young adult cigarette smokers (aged 18-30 years) were randomized in a 2 (implicit: red package vs. blue package) × 2 (explicit: corrective message vs. no corrective message) design to view an advertisement for previously commercially available RNCs. Outcomes were advertisement content recall, product beliefs, and use intentions. Participants' responses to open-ended assessment of their beliefs about the stimuli were coded to identify prevailing themes.
RESULTS
Red packaging and corrective messaging were independently associated with greater advertisement content recall (p = .01 and p = .04, respectively). There were no significant main or interaction effects on product beliefs or use intentions. Controlling for condition, advertisement content recall was significantly associated with less favorable product beliefs (p < .001) and favorable product beliefs were associated with intent to use the product (p < .001). Open-ended responses converged on the finding that respondents were interested in RNCs, but expressed skepticism about effectiveness and value.
CONCLUSIONS
Brief exposure to an RNC advertisement with red packaging and corrective messaging were each independently associated with greater advertisement content recall. The results indicate: (1) interest and confusion among young adult smokers regarding RNCs, (2) beliefs about RNCs are influenced by marketing, and (3) beliefs are associated with intention to use RNCs.
IMPLICATIONS
Findings from this study demonstrate the importance of advertising effects on beliefs about RNC products and support the need to regulate advertising and labeling alongside product regulation. More detailed study of advertisement features that affect consumers' beliefs about RNCs and how they impact their processing of explicit messaging about product risks will be important to guide regulatory decision-making.",2019,"Red packaging and corrective messaging were independently associated with greater advertisement content recall (p = .01 and p = .04, respectively).","['cigarettes', '426 young adult cigarette smokers (aged 18-30 years']","['× 2 (explicit: corrective message vs. no corrective message) design to view an advertisement for previously commercially available RNCs', '2 (implicit: red package vs. blue package']","['favorable product beliefs', 'product beliefs or use intentions', 'advertisement content recall, product beliefs, and use intentions', 'Red packaging and corrective messaging', 'advertisement content recall']","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0030176', 'cui_str': 'Packaging'}]",426.0,0.0295965,"Red packaging and corrective messaging were independently associated with greater advertisement content recall (p = .01 and p = .04, respectively).","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'Milken Institute School of Public Health, George Washington University, Washington, DC.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont Larner College of Medicine, Burlington, VT.'}, {'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'Niaura', 'Affiliation': 'New York University College of Global Public Health, New York, NY.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rehberg', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Lilianna', 'Initials': 'L', 'LastName': 'Phan', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mercincavage', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Luta', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz167']
976,31691436,"The effect of posture, exercise, and atrial pacing on atrioventricular conduction in systolic heart failure.","BACKGROUND
Optimization of atrioventricular (AV) intervals for cardiac resynchronization therapy (CRT) programming is typically performed in supine patients at rest, which may not reflect AV timing in other conditions.
OBJECTIVE
To evaluate the effects of posture, exercise, and atrial pacing on intrinsic AV intervals in patients with CRT devices.
METHODS
Rate-dependent A-V delay by exercise was a multicenter, prospective trial of patients in sinus rhythm following CRT implantation. Intracardiac electrograms were recorded to analyze atrial to right ventricular (ARV), atrial to left ventricular (ALV), and RV to LV (VV) time intervals. Heart rate was increased with incremental atrial pacing in different postures, followed by an exercise treadmill test.
RESULTS
This study included 36 patients. At rest, AV intervals changed minimally with posture. With atrial pacing, AV interval immediately increased compared with sinus rhythm, with ARV slopes being 8.1 ± 7.7, 8.8 ± 13.4, and 6.8 ± 6.5 milliseconds per beat per minute (ms/bpm) and ALV slopes being 8.2 ± 7.7, 9.1 ± 12.8, and 7.0 ± 6.5 ms/bpm for supine, standing and sitting positions, respectively. As the paced heart rate increased, ARV and ALV intervals increased more gradually with similar trends. Interventricular conduction times changed less than 0.2 ms/bpm with atrial pacing. During exercise, the direction of change of intrinsic ARV intervals, as heart rate increased, was variable between patients with relatively small overall group changes (0.1 ± 1.4 and 0.2 ± 1.2 ms/bpm for ARV and ALV, respectively).
CONCLUSION
Posture and exercise have a smaller effect on AV timing compared with atrial pacing. However, individualized optimization and dynamic rate related changes may be needed to maintain optimal fusion with left ventricular (LV) stimulation.",2019,"With atrial pacing, AV interval immediately increased compared with sinus rhythm, with ARV slopes being 8.1 ± 7.7, 8.8 ± 13.4, and 6.8 ± ","['patients with CRT devices', 'patients in sinus rhythm following CRT implantation', '36 patients']","['cardiac resynchronization therapy (CRT', 'Posture and exercise', 'posture, exercise, and atrial pacing']","['Interventricular conduction times', 'paced heart rate increased, ARV and ALV intervals', 'atrial to right ventricular (ARV), atrial to left ventricular (ALV), and RV to LV (VV) time intervals', 'Heart rate', 'heart rate', 'Intracardiac electrograms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]","[{'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0729936', 'cui_str': 'Intracardiac (qualifier value)'}]",36.0,0.0287109,"With atrial pacing, AV interval immediately increased compared with sinus rhythm, with ARV slopes being 8.1 ± 7.7, 8.8 ± 13.4, and 6.8 ± ","[{'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Niu', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yinghong', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, St. Paul, Minnesota.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Sturdivant', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'An', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, St. Paul, Minnesota.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14264']
977,31433496,Transplantation in adults with relapsed/refractory acute lymphoblastic leukemia who are treated with blinatumomab from a phase 3 study.,"BACKGROUND
Blinatumomab, a bispecific T-cell-engaging (BiTE®) immuno-oncology therapy, demonstrated superior overall survival versus standard-of-care chemotherapy (SOC) in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL) in the phase 3 TOWER study. Herein, the authors reported clinical features and outcomes for those patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) after treatment with blinatumomab.
METHODS
In the TOWER study, adults with R/R ALL were randomized 2:1 to receive blinatumomab or SOC. Study treatment consisted of 2 cycles of induction with blinatumomab or SOC followed by consolidation and maintenance therapy. At any time after the first cycle, patients who were eligible for HSCT could proceed to HSCT.
RESULTS
Of the 97 patients who underwent HSCT during the study, baseline characteristics generally were comparable and donor types were similar between the patients treated with blinatumomab (65 patients) and those receiving SOC (32 patients). There was no evidence to suggest that the survival benefit of HSCT differed between the patients treated with blinatumomab and those receiving SOC (P = .68). On the basis of descriptive statistics, a survival benefit of HSCT versus no HSCT was not observed in patients who achieved complete remission with full, partial, or incomplete hematologic recovery with blinatumomab (odds ratio, 1.17; 95% CI, 0.54-2.53). The best outcomes were achieved in patients with no prior salvage therapy and with minimal residual disease response to blinatumomab regardless of on-study HSCT status.
CONCLUSIONS
Survival was found to be driven by response to study treatment and by salvage status regardless of on-study HSCT status. These data should be interpreted with caution because the current study was not designed to prospectively assess survival outcomes associated with HSCT after blinatumomab.
LAY SUMMARY
Evidence before this study: Blinatumomab is associated with superior morphologic and molecular response rates and superior overall outcome when compared with standard of care chemotherapy in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Added value of this study: The best outcomes with blinatumomab were observed in patients who achieved minimal residual disease remission in first salvage treatment regardless of subsequent allogeneic stem cell transplantation (HSCT). Implications of all the available evidence: Patients achieving CR/CRh/CRi following blinatumomab can have a durable response with or without HSCT.",2019,"The best outcomes were achieved in patients with no prior salvage therapy and with minimal residual disease response to blinatumomab regardless of on-study HSCT status.
","['97 patients who underwent HSCT during the study', 'patients who achieved minimal residual disease remission in first salvage treatment regardless of subsequent allogeneic stem cell transplantation (HSCT', 'adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia', 'adults with relapsed/refractory acute lymphoblastic leukemia who are treated with blinatumomab from a phase 3 study', 'adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL', 'adults with R/R ALL']","['blinatumomab or SOC followed by consolidation and maintenance therapy', 'standard-of-care chemotherapy (SOC', 'HSCT', 'care chemotherapy', 'blinatumomab or SOC', 'blinatumomab', 'allogeneic hematopoietic stem cell transplantation (HSCT']",['survival benefit of HSCT'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0085405', 'cui_str': 'Salvage Treatment'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3853839', 'cui_str': 'blinatumomab'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C3853839', 'cui_str': 'blinatumomab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}]",65.0,0.0856182,"The best outcomes were achieved in patients with no prior salvage therapy and with minimal residual disease response to blinatumomab regardless of on-study HSCT status.
","[{'ForeName': 'Elias J', 'Initials': 'EJ', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gökbuget', 'Affiliation': 'Department of Medicine, Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Thomas', 'Affiliation': 'Department of Hematology, Lyon-Sud Hospital, Pierre-Benite, France.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Department of Hematology and Oncology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Topp', 'Affiliation': 'Department of Haematology, Wurzburg University, Wurzburg, Germany.'}, {'ForeName': 'Qui', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Franklin', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Forman', 'Affiliation': 'Gehr Family Center for Leukemia Research, City of Hope, Duarte, California.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Stein', 'Affiliation': 'Gehr Family Center for Leukemia Research, City of Hope, Duarte, California.'}]",Cancer,['10.1002/cncr.32335']
978,31796477,The premature closure of ROMPA clinical trial: mortality reduction in septic shock by plasma adsorption.,"OBJECTIVES
Coupled Plasma Filtration and Adsorption (CPFA) use in septic shock remains controversial. The objective is to clarify whether the application of high doses of CPFA in addition to the current clinical practice could reduce hospital mortality in septic shock patients in Intensive Care Units at 28 days and at 90 days follow-up.
DESIGN
We designed a prospective randomised clinical trial, Reducción de la Mortalidad Plasma-Adsorción (ROMPA), to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-β=0.8; n=190 (95×2)).
SETTING
Being aware of the pitfalls associated with previous medical device trials, we developed a training programme to improve CPFA use (especially clotting problems). The protocol was approved by the ethics committees of all participating centres. Circumstances beyond our control produced a change in recruitment conditions unacceptable to ROMPA researchers and the trial was discontinued.
PARTICIPANTS
By closure, five centres from an initial 10 fulfilled the necessary trial criteria, with 49 patients included, 30 in the control group (CG) and 19 in the intervention group (IG).
INTERVENTION
CPFA.
MAIN OUTCOME MEASURES
Hospital mortality at 28 days and 90 days follow-up.
RESULTS
After 28 days, 14 patients died (46.7%) from the CG and 11 (57.9%) from the IG, not reaching statistical significance (p=0.444). At 90 days, 19 patients had died (63.3%) from the CG and 11 patients (57.9%) from the IG, (p=0.878). The adjustment by propensity score or the use of the Kaplan-Meier technique failed to achieve statistical difference, neither by Intention to Treat nor by the Actual Intervention Received.
CONCLUSION
We herewith present the results gained from the prematurely closed trial. The results are inconclusive due to low statistical power but we consider that this data is of interest for the scientific community and potentially necessary for any ensuing debate.
REGISTER
NCT02357433 in clinicaltrials.gov.",2019,"We designed a prospective randomised clinical trial, Reducción de la Mortalidad Plasma-Adsorción (ROMPA), to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-β=0.8; n=190 (95×2)).
","['septic shock patients in Intensive Care Units at 28 days and at 90 days follow-up', 'By closure, five centres from an initial 10 fulfilled the necessary trial criteria, with 49 patients included, 30 in the control group (CG) and 19 in the intervention group (IG']",['CPFA'],"['Hospital mortality', 'hospital mortality']","[{'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",,0.148823,"We designed a prospective randomised clinical trial, Reducción de la Mortalidad Plasma-Adsorción (ROMPA), to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-β=0.8; n=190 (95×2)).
","[{'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Giménez-Esparza', 'Affiliation': 'Intensive Care Unit, Vega Baja Hospital of Orihuela, Orihuela, Alicante, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Portillo-Requena', 'Affiliation': 'Intensive Care Unit, Vega Baja Hospital of Orihuela, Orihuela, Alicante, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Colomina-Climent', 'Affiliation': 'Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Allegue-Gallego', 'Affiliation': 'Intensive Care Unit, General University Santa Lucía Hospital of Cartagena, Cartagena, Murcia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Galindo-Martínez', 'Affiliation': 'Intensive Care Unit, General University Santa Lucía Hospital of Cartagena, Cartagena, Murcia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mollà-Jiménez', 'Affiliation': 'Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Antón-Pascual', 'Affiliation': 'Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Mármol-Peis', 'Affiliation': 'Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Dólera-Moreno', 'Affiliation': 'Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Serra', 'Affiliation': 'Intensive Care Unit, Lluís Alcanyís Hospital of Xàtiva, Xàtiva, Valencia, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Martín-Ruíz', 'Affiliation': 'Intensive Care Unit, Lluís Alcanyís Hospital of Xàtiva, Xàtiva, Valencia, Spain.'}, {'ForeName': 'Pablo Juan', 'Initials': 'PJ', 'LastName': 'Fernández-Arroyo', 'Affiliation': 'Intensive Care Unit, Marina Baixa Hospital of Villajoyosa, Villajoyosa, Alicante, Spain.'}, {'ForeName': 'Eugenia María', 'Initials': 'EM', 'LastName': 'Blasco-Císcar', 'Affiliation': 'Intensive Care Unit, Marina Baixa Hospital of Villajoyosa, Villajoyosa, Alicante, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cánovas-Robles', 'Affiliation': 'Intensive Care Unit, General University Hospital of Alicante, Alicante, Alicante, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'González-Hernández', 'Affiliation': 'Intensive Care Unit, La Plana Hospital of Villarreal, Villarreal, Castellón, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Sánchez-Morán', 'Affiliation': 'Intensive Care Unit, La Plana Hospital of Villarreal, Villarreal, Castellón, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Solera-Suárez', 'Affiliation': 'Intensive Care Unit, Francesc de Borja Hospital of Gandía, Gandía, Valencia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Torres-Tortajada', 'Affiliation': 'Intensive Care Unit, Francesc de Borja Hospital of Gandía, Gandía, Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palazón-Bru', 'Affiliation': 'Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Alicante, Spain antonio.pb23@gmail.com.'}, {'ForeName': 'Vicente F', 'Initials': 'VF', 'LastName': 'Gil-Guillen', 'Affiliation': 'Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Alicante, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-030139']
979,31857298,"Opportunities for antibiotic optimisation and outcome improvement in patients with negative blood cultures: study protocol for a cluster-randomised crossover trial, the NO-BACT study.","INTRODUCTION
Patients with negative blood cultures (BCx) represent 85%-90% of all patients with BCx taken during hospital admission. This population usually includes a heterogeneous group of patients admitted with infectious diseases or febrile syndromes that require a blood culture. There is very little evidence of the clinical characteristics and antibiotic treatment given to these patients.
METHODS AND ANALYSIS
In a preliminary exploratory prospective cohort study of patients with BCx taken, the clinical/therapeutic characteristics and outcomes/antimicrobial stewardship opportunities of a population of patients with negative BCx will be analysed. In the second phase, using a cluster randomised crossover design, the implementation of an antimicrobial stewardship intervention targeting patients with negative BCx will be evaluated in terms of quality of antimicrobial use (duration and de-escalation), length of hospital stay and mortality.
ETHICS AND DISSEMINATION
This study has been and registered with clinicaltrials.gov. The findings of our study may support the implementation in clinical practice of an antimicrobial stewardship intervention to optimise the use of antibiotics in patients with negative BCx. The results of this study will be published in peer-reviewed journals and disseminated at national and international conferences.
TRIAL REGISTRATION NUMBER
NCT03535324.",2019,"In the second phase, using a cluster randomised crossover design, the implementation of an antimicrobial stewardship intervention targeting patients with negative BCx will be evaluated in terms of quality of antimicrobial use (duration and de-escalation), length of hospital stay and mortality.
","['Patients with negative blood cultures (BCx) represent 85%-90% of all patients with BCx taken during hospital admission', 'patients with BCx taken, the clinical/therapeutic characteristics and outcomes/antimicrobial stewardship opportunities of a population of patients with negative BCx', 'patients with negative BCx', 'patients admitted with infectious diseases or febrile syndromes that require a blood culture', 'patients with negative blood cultures']",['antimicrobial stewardship intervention'],"['quality of antimicrobial use (duration and de-escalation), length of hospital stay and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1273849', 'cui_str': 'Infectious Diseases Specialty'}, {'cui': 'C0743841', 'cui_str': 'Febrile syndrome'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0898047,"In the second phase, using a cluster randomised crossover design, the implementation of an antimicrobial stewardship intervention targeting patients with negative BCx will be evaluated in terms of quality of antimicrobial use (duration and de-escalation), length of hospital stay and mortality.
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Jiménez-Jorge', 'Affiliation': 'Clinical Research and Clinical Trials Unit, Hospital Universitario Virgen del Rocío, Seville, Spain silviajimenezjorge@gmail.com.'}, {'ForeName': 'Zaira R', 'Initials': 'ZR', 'LastName': 'Palacios-Baena', 'Affiliation': 'Infectious Diseases and Clinical Microbiology Department, Hospital Universitario Virgen Macarena. Instituto de Biomedicina de Sevilla (IBIS), Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Clara M', 'Initials': 'CM', 'LastName': 'Rosso-Fernández', 'Affiliation': 'Clinical Research and Clinical Trials Unit, Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Girón-Ortega', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Rodriguez-Baño', 'Affiliation': 'Infectious Diseases and Clinical Microbiology Department, Hospital Universitario Virgen Macarena. Instituto de Biomedicina de Sevilla (IBIS), Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Retamar', 'Affiliation': 'Infectious Diseases and Clinical Microbiology Department, Hospital Universitario Virgen Macarena. Instituto de Biomedicina de Sevilla (IBIS), Hospital Universitario Virgen Macarena, Seville, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-030062']
980,31857300,"Multicentre, randomised trial to investigate early nasal high-flow therapy in paediatric acute hypoxaemic respiratory failure: a protocol for a randomised controlled trial-a Paediatric Acute respiratory Intervention Study (PARIS 2).","INTRODUCTION
Acute hypoxaemic respiratory failure (AHRF) in children is the most frequent reason for non-elective hospital admission. During the initial phase, AHRF is a clinical syndrome defined for the purpose of this study by an oxygen requirement and caused by pneumonia, lower respiratory tract infections, asthma or bronchiolitis. Up to 20% of these children with AHRF can rapidly deteriorate requiring non-invasive or invasive ventilation. Nasal high-flow (NHF) therapy has been used by clinicians for oxygen therapy outside intensive care settings to prevent escalation of care. A recent randomised trial in infants with bronchiolitis has shown that NHF therapy reduces the need to escalate therapy. No similar data is available in the older children presenting with AHRF. In this study we aim to investigate in children aged 1 to 4 years presenting with AHRF if early NHF therapy compared with standard-oxygen therapy reduces hospital length of stay and if this is cost-effective compared with standard treatment.
METHODS AND ANALYSIS
The study design is an open-labelled randomised multicentre trial comparing early NHF and standard-oxygen therapy and will be stratified by sites and into obstructive and non-obstructive groups. Children aged 1 to 4 years (n=1512) presenting with AHRF to one of the participating emergency departments will be randomly allocated to NHF or standard-oxygen therapy once the eligibility criteria have been met (oxygen requirement with transcutaneous saturation <92%/90% (dependant on hospital standard threshold), diagnosis of AHRF, admission to hospital and tachypnoea ≥35 breaths/min). Children in the standard-oxygen group can receive rescue NHF therapy if escalation is required. The primary outcome is hospital length of stay. Secondary outcomes will include length of oxygen therapy, proportion of intensive care admissions, healthcare resource utilisation and associated costs. Analyses will be conducted on an intention-to-treat basis.
ETHICS AND DISSEMINATION
Ethics approval has been obtained in Australia (HREC/15/QRCH/159) and New Zealand (HDEC 17/NTA/135). The trial commenced recruitment in December 2017. The study findings will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. Authorship of all publications will be decided by mutual consensus of the research team.
TRIAL REGISTRATION NUMBER
ACTRN12618000210279.",2019,A recent randomised trial in infants with bronchiolitis has shown that NHF therapy reduces the need to escalate therapy.,"['infants with bronchiolitis', 'older children presenting with AHRF', 'Children aged 1 to 4 years (n=1512) presenting with AHRF to one of the participating emergency departments', 'children aged 1 to 4 years presenting with AHRF if early NHF therapy compared with', 'paediatric acute hypoxaemic respiratory failure']","['NHF and standard-oxygen therapy', 'Nasal high-flow (NHF) therapy', 'standard-oxygen therapy', 'early nasal high-flow therapy', 'NHF or standard-oxygen therapy', 'AHRF', 'NHF therapy']","['length of oxygen therapy, proportion of intensive care admissions, healthcare resource utilisation and associated costs', 'hospital length of stay']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia (disorder)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0085559'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.226783,A recent randomised trial in infants with bronchiolitis has shown that NHF therapy reduces the need to escalate therapy.,"[{'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Franklin', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia d.franklin2@uq.edu.au.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Shellshear', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Luregn J', 'Initials': 'LJ', 'LastName': 'Schlapbach', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Oakley', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Borland', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hoeppner', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Acworth', 'Affiliation': 'School of Medicine, The University Of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'McCay', 'Affiliation': 'Paediatrics, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Wallace', 'Affiliation': 'Paediatrics, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Mattes', 'Affiliation': ""Paediatrics, John Hunter Children's Hospital, Hunter Region Mail Centre, New South Wales, Australia.""}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Gangathimn', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wildman', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Fraser', 'Affiliation': 'Adult Intensive Care Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Moloney', 'Affiliation': 'Paediatric Department, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gavranich', 'Affiliation': 'Paediatrics, Ipswich Hospital, Ipswich, Queensland, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Waugh', 'Affiliation': 'Paediatrics, Caboolture Hospital, Caboolture, Queensland, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Hobbins', 'Affiliation': 'Paediatrics, Prince Charles Hospital, Chermside, Queensland, Australia.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Fahy', 'Affiliation': 'Paediatrics, Prince Charles Hospital, Chermside, Queensland, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Grew', 'Affiliation': 'Paediatrics, Redcliffe Hospital, Redcliffe, Queensland, Australia.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Gannon', 'Affiliation': 'The University of Queensland, Centre for Business and Economics of Health, St Lucia Qld, Queensland, Australia.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Gibbons', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Dalziel', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-030516']
981,31567887,Efficacy of Single- Versus Split-dose Polyethylene Glycol for Colonic Preparation in Children: A Randomized Control Study.,"OBJECTIVES
Polyethylene glycol (PEG) is the most effective colon-cleansing agent but volume-related adverse effects are common. Though split-dose PEG is used in adults, no pediatric study so-far has compared split-dose with single-dose PEG. We aimed at comparing the efficacy and tolerability of split-dose versus single-dose PEG for bowel preparation in children.
METHODS
Consecutive children (1-18 years) were randomized into either single-dose or split-dose PEG. Single-dose group received 4000 mL/1.73 m PEG solution day before colonoscopy whereas split-dose group received half dose day before and the remaining half on the day of colonoscopy. Effectiveness of bowel preparation was assessed on Aronchik scale, by the endoscopist who was blinded to the type of preparation. Interobserver variability was analyzed by comparing with independent scoring by the blinded trained endoscopy-nurse. The trial was registered with Clinical Trials Registry of India (Trail number 2017/08/009303).
RESULTS
Of the 220 randomized children, 179 completed the study (split-dose: 93, single-dose: 86). The mean age of the study population was 11.51 (4.82) years (72.6% boys). The efficacy of bowel preparation was better with split-dose (satisfactory preparation:76.34% vs 43.02%, P < 0.001) with almost perfect inter-observer agreement (k = 0.803). Nausea, vomiting, and sleep disturbance were significantly less in split-dose than single-dose group (P < 0.05). Split-dose patients were able to drink PEG solution faster (P = 0.002). Total sleep duration and uninterrupted sleep duration was also better in split-dose group as compared with single-dose (P = 0.001).
CONCLUSIONS
Split-dose PEG is more effective than single-dose regimen for bowel preparation with better tolerability and improved sleep quality in pediatric population.",2020,"The efficacy of bowel preparation was better with split-dose (satisfactory preparation:76.34% vs. 43.02%, p < 0.001) with almost perfect inter-observer agreement (k = 0.803).","['Children', 'children', 'The mean age of the study population was 11.51 (4.82) years (72.6%males', '220 randomized children, 179 completed the study (split-dose: 93, single-dose: 86', 'Consecutive children (1-18 years']","['split-dose versus single-dose PEG', 'Single Versus Split Dose Polyethylene Glycol', '4000\u200amL/1.73mPEG solution', 'single-dose or split-dose PEG', 'Polyethylene glycol (PEG']","['Nausea, vomiting and sleep disturbance', 'sleep quality', 'efficacy of bowel preparation', 'Total sleep duration and uninterrupted sleep duration', 'efficacy and tolerability', 'Aronchik scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0222045'}]",220.0,0.114045,"The efficacy of bowel preparation was better with split-dose (satisfactory preparation:76.34% vs. 43.02%, p < 0.001) with almost perfect inter-observer agreement (k = 0.803).","[{'ForeName': 'Parijat Ram', 'Initials': 'PR', 'LastName': 'Tripathi', 'Affiliation': 'Department of Pediatric Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ujjal', 'Initials': 'U', 'LastName': 'Poddar', 'Affiliation': ''}, {'ForeName': 'Surender Kumar', 'Initials': 'SK', 'LastName': 'Yachha', 'Affiliation': ''}, {'ForeName': 'Moinak Sen', 'Initials': 'MS', 'LastName': 'Sarma', 'Affiliation': ''}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002511']
982,31722024,Effect of Intranasal vs Intramuscular Naloxone on Opioid Overdose: A Randomized Clinical Trial.,"Importance
Previous unblinded clinical trials suggested that the intranasal route of naloxone hydrochloride was inferior to the widely used intramuscular route for the reversal of opioid overdose.
Objective
To test whether a dose of naloxone administered intranasally is as effective as the same dose of intramuscularly administered naloxone in reversing opioid overdose.
Design, Setting, and Participants
A double-blind, double-dummy randomized clinical trial was conducted at the Uniting Medically Supervised Injecting Centre in Sydney, Australia. Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017. Eligible clients were aged 18 years or older with a history of injecting drug use (n = 197). Intention-to-treat analysis was performed for all participants who received both intranasal and intramuscular modes of treatment (active or placebo).
Interventions
Clients were randomized to receive 1 of 2 treatments: (1) intranasal administration of naloxone hydrochloride 800 μg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride 800 μg per 1 mL and intranasal administration of placebo 1 mL.
Main Outcomes and Measures
The primary outcome measure was the need for a rescue dose of intramuscular naloxone hydrochloride (800 μg) 10 minutes after the initial treatment. Secondary outcome measures included time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score greater than or equal to 13.
Results
A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2%) were randomized to intramuscular naloxone dose and 104 (52.8%) to intranasal naloxone dose. Clients randomized to intramuscular naloxone administration were less likely to require a rescue dose of naloxone compared with clients randomized to intranasal naloxone administration (8 [8.6%] vs 24 [23.1%]; odds ratio, 0.35; 95% CI, 0.15-0.66; P = .002). A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone. No major adverse events were reported for either group.
Conclusions and Relevance
This trial showed that intranasally administered naloxone in a supervised injecting facility can reverse opioid overdose but not as efficiently as intramuscularly administered naloxone can, findings that largely replicate those of previous unblinded clinical trials. These results suggest that determining the optimal dose and concentration of intranasal naloxone to respond to opioid overdose in real-world conditions is an international priority.
Trial Registration
anzctr.org.au Identifier: ACTRN12611000852954.",2019,"A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone.","['Eligible clients were aged 18 years or older with a history of injecting drug use (n\u2009=\u2009197', 'Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017', 'A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2', 'Uniting Medically Supervised Injecting Centre in Sydney, Australia']","['anzctr.org.au Identifier', 'intranasal and intramuscular modes of treatment (active or placebo', 'placebo 1 mL.\nMain Outcomes and Measures', 'intramuscular naloxone', 'naloxone hydrochloride 800 μg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride', 'naloxone', 'Intranasal vs Intramuscular Naloxone', 'intranasal naloxone', 'naloxone hydrochloride']","['Opioid Overdose', 'time to respiratory rate', 'time to Glasgow Coma Scale score', 'time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0700549', 'cui_str': 'Naloxone Hydrochloride'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439386', 'cui_str': 'breaths per minute'}]",197.0,0.34555,"A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dietze', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Jauncey', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Salmon', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'van Beek', 'Affiliation': 'South Eastern Sydney Local Health District, New South Wales, Australia.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Justice Health Forensic Mental Health Network, New South Wales Health, Randwick, New South Wales, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kerr', 'Affiliation': 'Centre for Quality and Patient Safety, School of Nursing and Midwifery, Deakin University, Geelong, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14977']
983,31898804,Knee Osteonecrosis: Cell Therapy with Computer-assisted Navigation.,"BACKGROUND
The knee is the second-most common location for osteonecrosis, although it is affected much less often than the hip. Core decompression by precise drilling into ischemic lesions of the femoral condyle while remaining extra-articular is a challenge, particularly in obese patients. For cell therapy, exact localization of the injection point is important to avoid intra-articular injection.
METHODS
The precision of drilling with computer-based navigation was compared to that of conventional fluoroscopy-based drilling. A prospective, randomized study was conducted using both surgical trainees without experience and expert surgeons. First, participants performed the surgical task (core decompression) on a cadaver knee using fluoroscopic guidance or computer-based navigation. Performance was determined by the radiographic analysis of trocar placement. Next, 12 consecutive patients with bilateral symptomatic secondary (corticosteroids) osteonecrosis without collapse were included in a clinical prospective, randomized, controlled study. The 24 knees were treated using conventional fluoroscopy with expert surgeons on one side and computer-based navigation with surgical trainees on the contralateral side. Bone marrow aspirated from the two iliac crests was mixed before concentration. Each side received the same volume of concentrated bone marrow and the same number of cells (95,000 ± 25,000 cells; counted as CFU-F).
RESULTS
In the cadaver tests, the distance to the desired center-point of the lesion in the navigated group (1.6 mm) was significantly less than that in the control group (5.9 mm; p<0.001). Significant differences were also found in the number of drilling corrections (p<0.001), the radiation time needed (p<0.001), the risk of intra-articular penetration, and the risk of ligament injuries. In patients, computer navigation achieved results closer to the ideal position of the trocar, with better trocar placement in terms of tip-to-subchondral distance and ideal center position within the target for injection of stem cells. At the most recent follow-up (5 years), an increase in precision with computer-assisted navigation resulted in less collapse (4 vs. 1) and better volume of repair (11.4 vs 4.2 cm3) for knees treated with the computer-assisted technique. Failures were related to missing the target with intra-articular penetration.
CONCLUSIONS
Computer-assisted navigation improved precision with less radiation. The findings of this study suggest that computer navigation may be safely used in a basic procedure for the injection of stem cells in knee osteonecrosis.",2020,"Significant differences were also found in the number of drilling corrections (p<0.001), the radiation time needed (p<0.001), the risk of intra-articular penetration, and the risk of ligament injuries.","['surgical trainees without experience and expert surgeons', 'obese patients', '12 consecutive patients with bilateral symptomatic secondary (corticosteroids) osteonecrosis without collapse']","['computer navigation', 'conventional fluoroscopy with expert surgeons on one side and computer-based navigation with surgical trainees on the contralateral side', 'conventional fluoroscopy-based drilling', 'Computer-assisted Navigation', 'surgical task (core decompression', 'cadaver knee using fluoroscopic guidance or computer-based navigation']","['radiation time needed (p<0.001), the risk of intra-articular penetration, and the risk of ligament injuries', 'volume of repair', 'number of drilling corrections']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0560563', 'cui_str': 'Fluoroscopic guidance (procedure)'}]","[{'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0435001', 'cui_str': 'Ligament injury (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0213412,"Significant differences were also found in the number of drilling corrections (p<0.001), the radiation time needed (p<0.001), the risk of intra-articular penetration, and the risk of ligament injuries.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Hernigou', 'Affiliation': 'University of Paris Est, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gerber', 'Affiliation': 'Henri-Mondor University Hospital, Créteil, France.'}, {'ForeName': 'Jean Charles', 'Initials': 'JC', 'LastName': 'Auregan', 'Affiliation': 'Hôpital Antoine-Béclère Université Paris-Sud, Clamart, Franc.'}]",Surgical technology international,[]
984,31898965,Relation of White Blood Cell Count to Bleeding and Ischemic Events in Patients With Acute Coronary Syndrome (from the ATLAS ACS 2-TIMI 51 Trial).,"An elevated white blood cell (WBC) count is associated with an increased risk of ischemic events among acute coronary syndrome (ACS) patients, but the association between WBC count and bleeding in ACS patients is not well established. The aim of this analysis was to assess and compare the association between WBC count and the occurrence of short- and long-term bleeding and ischemic events. This was a post hoc analysis of the ATLAS ACS2-TIMI 51 trial. A subset of patients had a WBC count measurement at baseline (n = 14,231, 91.6%). Univariate and multivariable Cox proportional hazard models were constructed to determine if there is an association between WBC count at baseline and a composite outcome of Thrombolysis in Myocardial Infarction (TIMI) major and minor bleeds at 30 days and 1 year. Variables with a p <0.2 in the univariate analysis were included as potential parameters in the backward selection process A similar multivariable model was constructed to assess the association between WBC count and a composite ischemic endpoint of cardiovascular death, myocardial infarction and stroke. An increased risk of bleeding per a 1 × 10 9 /L increase in WBC at baseline was observed at 30 days (Adjusted hazard ratio [HR] 1.08 95% confidence interval [CI] 1.01 to 1.17, p = 0.019) but not at 1 year (Adjusted HR 1.02 95% CI 0.97 to 1.08, p = 0.409). Additionally, an increased risk of ischemia per a 1 × 10 9 /L increase in WBC at baseline was observed at 30 days (Adjusted HR 1.07, 95% CI: 1.03 to 1.12, p = 0.002) and at 1 year (Adjusted HR 1.05 95% CI 1.02 to 1.08, p = 0.001 at 1 year). In conclusion, a higher WBC count at baseline was associated with an increased risk of the composite bleeding endpoint by 30 days but not at 1 year. The association between WBC count and the risk of the composite ischemic endpoint was significant at 30 days and 1 year.",2020,An increased risk of bleeding per a 1 × 10 9 /L increase in WBC at baseline was observed at 30 days (Adjusted hazard ratio [HR],"['acute coronary syndrome (ACS) patients', 'Patients With Acute Coronary Syndrome (from the ATLAS ACS 2-TIMI 51 Trial']",[],"['WBC count measurement', 'WBC', 'elevated white blood cell (WBC) count', 'WBC count and bleeding', 'WBC count and the occurrence of short- and long-term bleeding and ischemic events', 'risk of ischemia', 'WBC count and the risk of the composite ischemic endpoint', 'Myocardial Infarction (TIMI) major and minor bleeds', 'WBC count', 'WBC count and a composite ischemic endpoint of cardiovascular death, myocardial infarction and stroke', 'risk of bleeding']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004171', 'cui_str': 'Atlases'}]",[],"[{'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3160770', 'cui_str': 'Minor bleed'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.0979968,An increased risk of bleeding per a 1 × 10 9 /L increase in WBC at baseline was observed at 30 days (Adjusted hazard ratio [HR],"[{'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Alkhalfan', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Nafee', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Megan K', 'Initials': 'MK', 'LastName': 'Yee', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Chi', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Kalayci', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Plotnikov', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: mgibson@bidmc.harvard.edu.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.12.007']
985,31609692,Psychophysiological Responses in People Living with Dementia after an Art Gallery Intervention: An Exploratory Study.,"The use of existing public spaces by people living with dementia, such as museums and art galleries, are becoming popular due to their ability to facilitate programs which promote social engagement and inclusion. However, few studies have investigated physiological outcomes of art gallery-based programs. Using a quasi-experimental design, the present study aimed to investigate the levels of salivary biomarkers of cortisol and interleukin-6, quality of life (QoL), depressive symptoms, cognition, and wellbeing, after attending the National Gallery of Australia (NGA) Art and Dementia program. Twenty-eight people living with dementia, each supported by a carer or family member, were recruited for a six-week program and were followed up at twelve weeks. In total, 25 participants (17 female; mean age 84.6±7.27 years) completed the study, and 22 provided viable saliva samples. The waking to evening salivary cortisol ratio was higher post-intervention (p = 0.033), and returned to baseline levels at follow-up (p = 1.00), indicating a more dynamic salivary cortisol rhythm in response to the six-week program. Interleukin-6 levels remained unchanged (p = 0.664). No improvements in QoL (DEMQOL-Carer) were observed between baseline and post-intervention (p = 0.076). However, self-reported depressive symptoms decreased post-intervention compared with baseline (p = 0.015), and memory (immediate recall) (p = 0.009) and verbal fluency (p = 0.027) improved between the same timepoints. The NGA Art and Dementia program appears to have quantifiable benefits, including improved hypothalamic-pituitary-adrenal axis function, justifying a need for longer controlled trial inclusive of physiological outcomes.",2019,"The waking to evening salivary cortisol ratio was higher post-intervention (p = 0.033), and returned to baseline levels at follow-up (p = 1.00), indicating a more dynamic salivary cortisol rhythm in response to the six-week program.","['Twenty-eight people living with dementia, each supported by a carer or family member', '25 participants (17 female; mean age 84.6±7.27 years) completed the study, and 22 provided viable saliva samples', 'People Living with Dementia after an Art Gallery Intervention']",[],"['verbal fluency', 'depressive symptoms', 'levels of salivary biomarkers of cortisol and interleukin-6, quality of life (QoL), depressive symptoms, cognition, and wellbeing, after attending the National Gallery of Australia (NGA', 'QoL (DEMQOL-Carer', 'waking to evening salivary cortisol ratio', 'dynamic salivary cortisol rhythm', 'Interleukin-6 levels', 'Psychophysiological Responses']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]",[],"[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0034380'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",25.0,0.0472076,"The waking to evening salivary cortisol ratio was higher post-intervention (p = 0.033), and returned to baseline levels at follow-up (p = 1.00), indicating a more dynamic salivary cortisol rhythm in response to the six-week program.","[{'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': ""D'Cunha"", 'Affiliation': 'Faculty of Health, University of Canberra, Kirinari Street, Bruce, Canberra, ACT, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McKune', 'Affiliation': 'Faculty of Health, University of Canberra, Kirinari Street, Bruce, Canberra, ACT, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Isbel', 'Affiliation': 'Faculty of Health, University of Canberra, Kirinari Street, Bruce, Canberra, ACT, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kellett', 'Affiliation': 'Faculty of Health, University of Canberra, Kirinari Street, Bruce, Canberra, ACT, Australia.'}, {'ForeName': 'Ekavi N', 'Initials': 'EN', 'LastName': 'Georgousopoulou', 'Affiliation': 'Collaborative Research in Bioactives and Biomarkers (CRIBB) Group, Kirinari Street, Bruce, Canberra, ACT, Australia.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Naumovski', 'Affiliation': 'Faculty of Health, University of Canberra, Kirinari Street, Bruce, Canberra, ACT, Australia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190784']
986,31881852,"Leukocyte telomere length and serum polyunsaturated fatty acids, dietary habits, cardiovascular risk factors and features of myocardial infarction in elderly patients.","BACKGROUND
Telomeres are non-coding sequences at the end of eukaryote chromosomes, which in complex with associated proteins serve to protect subtelomeric DNA. Telomeres shorten with each cell division, are regarded as a biomarker for aging and have also been suggested to play a role in atherosclerosis and cardiovascular disease (CVD). The aim of the present study was to explore the associations between leukocyte telomere length and serum polyunsaturated fatty acids, diet, cardiovascular risk factors and features of myocardial infarction (MI) in elderly patients.
METHODS
The material is based upon the first 299 included patients in the OMEMI trial, where patients aged 70-82 years of age are randomized to receive omega-3 supplements or corn oil (placebo) after MI. Patients were included 2-8 weeks after the index MI. DNA was extracted from whole blood, and leukocyte telomere length (LTL) was analyzed by qPCR and reported as a number relative to a reference gene. Serum long chain polyunsaturated fatty acid (LCPUFA) content was analyzed by gas chromatography. Diet was evaluated with the validated SmartDiet food frequency questionnaire. Medical records, patient interviews and clinical examination provided previous medical history and anthropometric data. Non-parametric statistical tests were used.
RESULTS
Median (25, 75 percentile) LTL was 0.55 (0.42, 0.72). Patients had a median age of 75 years, 70.2% were male and 45.2% used omega-3 supplements. There was a weak, but significant correlation between LTL and linoleic acid (r = 0.139, p = 0.017), but not with other LCPUFAs. There was a trend towards longer telomeres with a healthier diet, but this did not reach statistical significance (p = 0.073). No associations were found between LTL and CVD risk factors or features of MI.
CONCLUSIONS
In our population of elderly with a recent myocardial infarction LTL was associated with linoleic acid concentrations, but not with other LCPUFAs. Patients with a healthy diet tended to have longer telomeres. The limited associations may be due to age and the narrow age-span in our population. Further studies, designed to detect longitudinal changes should be performed to explore the role of telomeres in cardiovascular aging.
TRIAL REGISTRATION
Clinical trials no. NCT01841944, registration date April 29, 2013.",2019,"There was a trend towards longer telomeres with a healthier diet, but this did not reach statistical significance (p = 0.073).","['Median (25, 75 percentile', 'Patients had a median age of 75\u2009years, 70.2% were male and 45.2% used omega-3 supplements', 'elderly patients', '299 included patients in the OMEMI trial, where patients aged 70-82\u2009years of age']",['omega-3 supplements or corn oil (placebo'],"['LTL and CVD risk factors or features of MI', 'Serum long chain polyunsaturated fatty acid (LCPUFA) content', 'Leukocyte telomere length and serum polyunsaturated fatty acids, dietary habits, cardiovascular risk factors and features of myocardial infarction', 'LTL and linoleic acid', 'leukocyte telomere length and serum polyunsaturated fatty acids, diet, cardiovascular risk factors and features of myocardial infarction (MI']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",75.0,0.044887,"There was a trend towards longer telomeres with a healthier diet, but this did not reach statistical significance (p = 0.073).","[{'ForeName': 'Are A', 'Initials': 'AA', 'LastName': 'Kalstad', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital, Ullevål, Postboks 4956 Nydalen, 0424, Oslo, Norway. areaka@medisin.uio.no.'}, {'ForeName': 'Sjur', 'Initials': 'S', 'LastName': 'Tveit', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Peder L', 'Initials': 'PL', 'LastName': 'Myhre', 'Affiliation': 'Department of Cardiology, Akershus University Hospital HF, Lørenskog, Norway.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Laake', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital, Ullevål, Postboks 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Trine B', 'Initials': 'TB', 'LastName': 'Opstad', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital, Ullevål, Postboks 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Arnljot', 'Initials': 'A', 'LastName': 'Tveit', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Solheim', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital, Ullevål, Postboks 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Arnesen', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital, Ullevål, Postboks 4956 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital, Ullevål, Postboks 4956 Nydalen, 0424, Oslo, Norway.'}]",BMC geriatrics,['10.1186/s12877-019-1383-9']
987,31814707,"Safety, pharmacokinetics and pharmacodynamics of the selective glucocorticoid receptor modulator AZD7594, following inhalation in healthy Japanese volunteers.","Introduction
AZD7594 is a non-steroidal, selective, glucocorticoid receptor modulator (SGRM), currently in development for the treatment of asthma and chronic obstructive pulmonary disease. This paper reports a randomized placebo-controlled dose escalation study in healthy Japanese male subjects.
Methods
Inhaled AZD7594 was administered as one single dose at day 1 (day 1-4), with subsequent multiple daily doses (day 5-16) via a multiple-dose dry powder inhaler for 12 days of once-daily treatment. At each dose level, subjects were randomized to AZD7594 (n=7) or placebo (n=2). The safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD7594 were evaluated.
Results
Inhaled AZD7594 was safe and well tolerated up to and including the highest dose 1600 µg tested. Plasma exposure suggested dose-proportional PK. The urinary excretion of AZD7594 was negligible (<0.02%). Dose-related effects were observed for 24 hrs plasma cortisol; however, significant cortisol suppression (25%) was only seen at the highest dose level following multiple doses. There were no or only marginal effects on other biomarkers tested (dehydroepiandrosterone sulfate [DHEA-S] and osteocalcin).
Conclusion
In conclusion, the early clinical evaluation of inhaled AZD7594 suggests that this novel SGRM is well tolerated in the dose range investigated and also in a Japanese population. It shows dose-proportional plasma exposure, moderate accumulation and has limited impact on systemic markers of glucocorticoid activity.",2019,"There were no or only marginal effects on other biomarkers tested (dehydroepiandrosterone sulfate [DHEA-S] and osteocalcin).
","['healthy Japanese male subjects', 'healthy Japanese volunteers']","['AZD7594', 'selective glucocorticoid receptor modulator AZD7594', 'placebo', 'Inhaled AZD7594']","['Safety, pharmacokinetics and pharmacodynamics', 'biomarkers tested (dehydroepiandrosterone sulfate [DHEA-S] and osteocalcin', 'safe and well tolerated', 'cortisol suppression', 'safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD7594', 'urinary excretion of AZD7594']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0034809', 'cui_str': 'Glucocorticoid Receptor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0057277', 'cui_str': 'Prasterone Sulfate'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",,0.0817447,"There were no or only marginal effects on other biomarkers tested (dehydroepiandrosterone sulfate [DHEA-S] and osteocalcin).
","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Prothon', 'Affiliation': 'Clinical Pharmacology, ADME, and AI, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wählby Hamrén', 'Affiliation': 'Clinical Pharmacology, ADME, and AI, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Tehler', 'Affiliation': 'Early Product Development, Pharmaceutical Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Yoon', 'Affiliation': 'Early Phase Clinical Unit, PAREXEL, Glendale, CA, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Forsman', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune (RIA), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Arfvidsson', 'Affiliation': 'Clinical Sample and Bioanalytical Science, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune (RIA), BioPharmaceuticals R&D, AstraZeneca, Boston, MA, USA.'}, {'ForeName': 'Yingxue', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Clinical Pharmacology, ADME, and AI, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Boston, MA, USA.'}]","Drug design, development and therapy",['10.2147/DDDT.S215170']
988,31202468,"Safety and efficacy of deferiprone for pantothenate kinase-associated neurodegeneration: a randomised, double-blind, controlled trial and an open-label extension study.","BACKGROUND
Pantothenate kinase-associated neurodegeneration (PKAN) is a rare genetic disorder characterised by progressive generalised dystonia and brain iron accumulation. We assessed whether the iron chelator deferiprone can reduce brain iron and slow disease progression.
METHODS
We did an 18-month, randomised, double-blind, placebo-controlled trial (TIRCON2012V1), followed by a pre-planned 18-month, open-label extension study, in patients with PKAN in four hospitals in Germany, Italy, England, and the USA. Patients aged 4 years or older with a genetically confirmed diagnosis of PKAN, a total score of at least 3 points on the Barry-Albright Dystonia (BAD) scale, and no evidence of iron deficiency, neutropenia, or abnormal hepatic or renal function, were randomly allocated (2:1) to receive an oral solution of either deferiprone (30 mg/kg per day divided into two equal doses) or placebo for 18 months. Randomisation was done with a centralised computer random number generator and with stratification based on age group at onset of symptoms. Patients were allocated to groups by a randomisation team not masked for study intervention that was independent of the study. Patients, caregivers, and investigators were masked to treatment allocation. Co-primary endpoints were the change from baseline to month 18 in the total score on the BAD scale (which measures severity of dystonia in eight body regions) and the score at month 18 on the Patient Global Impression of Improvement (PGI-I) scale, which is a patient-reported interpretation of symptom improvement. Efficacy analyses were done on all patients who received at least one dose of the study drug and who provided a baseline and at least one post-baseline efficacy assessment. Safety analyses were done for all patients who received at least one dose of the study drug. Patients who completed the randomised trial were eligible to enrol in a single-arm, open-label extension study of another 18 months, in which all participants received deferiprone with the same regimen as the main study. The trial was registered on ClinicalTrials.gov, number NCT01741532, and EudraCT, number 2012-000845-11.
FINDINGS
Following a screening of 100 prospective patients, 88 were randomly assigned to the deferiprone group (n=58) or placebo group (n=30) between Dec 13, 2012, and April 21, 2015. Of these, 76 patients completed the study (49 in the deferiprone group and 27 in the placebo group). After 18 months, the BAD score worsened by a mean of 2·48 points (SE 0·63) in patients in the deferiprone group versus 3·99 points (0·82) for patients in the control group (difference -1·51 points, 95% CI -3·19 to 0·16, p=0·076). No subjective change was detected as assessed by the PGI-I scale: mean scores at month 18 were 4·6 points (SE 0·3) for patients in the deferiprone group versus 4·7 points (0·4) for those in the placebo group (p=0·728). In the extension study, patients continuing deferiprone retained a similar rate of disease progression as assessed by the BAD scale (1·9 points [0·5] in the first 18 months vs 1·4 points [0·4] in the second 18 months, p=0·268), whereas progression in patients switching from placebo to deferiprone seemed to slow (4·4 points [1·1] vs 1·4 points [0·9], p=0·021). Patients did not detect a change in their condition after the additional 18 months of treatment as assessed by the PGI-I scale, with mean scores of 4·1 points [0·2] in the deferiprone-deferiprone group and of 4·7 points [0·3] in the placebo-deferiprone group. Deferiprone was well tolerated and adverse events were similar between the treatment groups, except for anaemia, which was seen in 12 (21%) of 58 patients in the deferiprone group, but was not seen in any patients in the placebo group. No patient discontinued therapy because of anaemia, and three discontinued because of moderate neutropenia. There was one death in each group of the extension study and both were secondary to aspiration. Neither of these events was considered related to deferiprone use.
INTERPRETATION
Deferiprone was well tolerated, achieved target engagement (lowering of iron in the basal ganglia), and seemed to somewhat slow disease progression at 18 months, although not significantly, as assessed by the BAD scale. These findings were corroborated by the results of an additional 18 months of treatment in the extension study. The subjective PGI-I scale was largely unchanged during both study periods, indicating that might not be an adequate tool for assessment of disease progression in patients with PKAN. Our trial provides the first indication of a decrease in disease progression in patients with neurodegeneration with brain iron accumulation. The extensive information collected and long follow-up of patients in the trial will improve the definition of appropriate endpoints, increase the understanding of the natural history, and thus help to shape the design of future trials in this ultra-orphan disease.
FUNDING
European Commission, US Food and Drug Administration, and ApoPharma Inc.",2019,"Deferiprone was well tolerated and adverse events were similar between the treatment groups, except for anaemia, which was seen in 12 (21%) of 58 patients in the deferiprone group, but was not seen in any patients in the placebo group.","['patients with PKAN in four hospitals in Germany, Italy, England, and the USA', 'patients with PKAN', 'patients with neurodegeneration with brain iron accumulation', 'pantothenate kinase-associated neurodegeneration', 'Patients aged 4 years or older with a genetically confirmed diagnosis of PKAN, a total score of at least 3 points on the Barry-Albright Dystonia (BAD) scale, and no evidence of iron deficiency, neutropenia, or abnormal hepatic or renal function', 'group (n=30) between Dec 13, 2012, and April 21, 2015', '76 patients completed the study (49 in the deferiprone group and 27 in the placebo group']","['deferiprone', 'oral solution of either deferiprone', 'placebo', 'Deferiprone']","['subjective change', 'subjective PGI-I scale', 'disease progression', 'rate of disease progression', 'tolerated and adverse events', 'Patient Global Impression of Improvement (PGI-I) scale', 'BAD score', 'PGI-I scale: mean scores', 'BAD scale', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2931845', 'cui_str': 'Neurodegeneration with brain iron accumulation (NBIA)'}, {'cui': 'C0070043', 'cui_str': ""ATP-pantothenate 4'-phosphotransferase""}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013421', 'cui_str': 'Muscle Dystonia'}, {'cui': 'C0222045'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement (assessment scale)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.274924,"Deferiprone was well tolerated and adverse events were similar between the treatment groups, except for anaemia, which was seen in 12 (21%) of 58 patients in the deferiprone group, but was not seen in any patients in the placebo group.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klopstock', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany; German Center for Neurodegenerative Diseases, Munich, Germany; Munich Cluster for Systems Neurology, Munich, Germany. Electronic address: thomas.klopstock@med.lmu.de.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Tricta', 'Affiliation': 'ApoPharma Inc, Toronto, ON, Canada.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Neumayr', 'Affiliation': ""Department of Hematology Oncology, UCSF Benioff Children's Hospital and Research Center Oakland, Oakland, CA, USA.""}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Karin', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Zorzi', 'Affiliation': 'Department of Pediatric Neuroscience, Neurological Institute Carlo Besta, Milan, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fradette', 'Affiliation': 'ApoPharma Inc, Toronto, ON, Canada.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kmieć', 'Affiliation': ""Department of Neurology and Epileptology, Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Boriana', 'Initials': 'B', 'LastName': 'Büchner', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Steele', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Horvath', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, UK; Department of Clinical Neurosciences, Cambridge University, Cambridge, UK.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Chinnery', 'Affiliation': 'Department of Clinical Neurosciences, Cambridge University, Cambridge, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Küpper', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Neuhofer', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Kálmán', 'Affiliation': 'Institute of Laboratory Medicine, Szentagothai Research Center, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Dušek', 'Affiliation': 'Charles University, Prague, Czech Republic.'}, {'ForeName': 'Zuhal', 'Initials': 'Z', 'LastName': 'Yapici', 'Affiliation': 'Department of Child Neurology, Istanbul Faculty of Medicine, Turkey.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Wilson', 'Affiliation': 'Institute of Cellular Medicine and Newcastle Magnetic Resonance Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'ApoPharma Inc, Toronto, ON, Canada.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Zibordi', 'Affiliation': 'Department of Pediatric Neuroscience, Neurological Institute Carlo Besta, Milan, Italy.'}, {'ForeName': 'Nardo', 'Initials': 'N', 'LastName': 'Nardocci', 'Affiliation': 'Department of Pediatric Neuroscience, Neurological Institute Carlo Besta, Milan, Italy.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Aguilar', 'Affiliation': ""Pediatric Rehabilitation Department, UCSF Benioff Children's Hospital and Research Center Oakland, Oakland, CA, USA.""}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Hayflick', 'Affiliation': 'Department of Molecular & Medical Genetics, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spino', 'Affiliation': 'ApoPharma Inc, Toronto, ON, Canada.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Blamire', 'Affiliation': 'Institute of Cellular Medicine and Newcastle Magnetic Resonance Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Hogarth', 'Affiliation': 'Department of Molecular & Medical Genetics, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Vichinsky', 'Affiliation': ""Department of Hematology Oncology, UCSF Benioff Children's Hospital and Research Center Oakland, Oakland, CA, USA.""}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30142-5']
989,31127705,The healing effect of Wharton's jelly stem cells seeded on biological scaffold in chronic skin ulcers: A randomized clinical trial.,"BACKGROUND
Chronic wound or nonhealing ulcer is essentially a wound that does not progress normally through the wound healing process. This study assessed the healing effect of umbilical cord Wharton's jelly stem cells seeded on biological scaffold in chronic skin ulcers.
MATERIALS AND METHODS
In a randomized clinical trial, five patients between 30 and 60 years with chronic diabetic wounds were enrolled. To cover the wounds, acellular amniotic membrane seeded with Wharton's jelly mesenchymal stem cells (WJSCs) was used for 9 days, every 3 days with a follow-up of 1 month. The percentage and time of wound healing and the size of wound were recorded for each patient.
RESULTS
In treated patients, the wound healing time and wound size significantly decreased, and after 6 and 9 days, the wound size significantly declined (P < 0.002).
CONCLUSION
As WJSCs seeded on amniotic membrane could significantly accelerate the healing effect in chronic diabetic wounds, they can be an alternative source in tissue engineering and repair of chronic ulcers.",2019,"In treated patients, the wound healing time and wound size significantly decreased, and after 6 and 9 days, the wound size significantly declined (P < 0.002).
","['five patients between 30 and 60\xa0years with chronic diabetic wounds were enrolled', 'chronic skin ulcers']","[""acellular amniotic membrane seeded with Wharton's jelly mesenchymal stem cells (WJSCs"", ""Wharton's jelly stem cells seeded"", ""umbilical cord Wharton's jelly stem cells seeded""]","['percentage and time of wound healing and the size of wound', 'wound healing time and wound size', 'wound size', 'healing effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0157738', 'cui_str': 'Chronic ulcer of skin (disorder)'}]","[{'cui': 'C0002630', 'cui_str': 'Amniotic Membrane'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0230987', 'cui_str': 'Wharton Jelly'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",5.0,0.0385349,"In treated patients, the wound healing time and wound size significantly decreased, and after 6 and 9 days, the wound size significantly declined (P < 0.002).
","[{'ForeName': 'Seyedeh-Sara', 'Initials': 'SS', 'LastName': 'Hashemi', 'Affiliation': 'Burn and Wound Healing Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Mohammadi', 'Affiliation': 'Burn and Wound Healing Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Kabiri', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Hashempoor', 'Affiliation': 'Burn and Wound Healing Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahdokht', 'Initials': 'M', 'LastName': 'Mahmoodi', 'Affiliation': 'Burn and Wound Healing Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Minimal Invasive Laparascopy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Mehrabani', 'Affiliation': 'Burn and Wound Healing Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12931']
990,31811006,Effectiveness and cost-utility of a multifaceted eHealth strategy to improve back pain beliefs of patients with non-specific low back pain: a cluster randomised trial.,"OBJECTIVES
To assess the effectiveness and cost-utility of a multifaceted eHealth strategy compared to usual care in improving patients' back pain beliefs, and in decreasing disability and absenteeism.
DESIGN
Stepped-wedge cluster randomised trial with parallel economic evaluation.
SETTING
Dutch primary healthcare.
PARTICIPANTS
Patients diagnosed with non-specific low back pain by their general practitioner or physiotherapist. Patients with serious comorbidities or confirmed pregnancy were excluded. 779 patients were randomised into intervention group (n=331, 59% female; 60.4% completed study) or control group (n=448, 57% female; 77.5% completed study).
INTERVENTIONS
The intervention consisted of a multifaceted eHealth strategy that included a (mobile) website, digital monthly newsletters, and social media platforms. The website provided information about back pain, practical advice (eg, on self-management), working and returning to work with back pain, exercise tips, and short video messages from healthcare providers and patients providing information and tips. The control consisted of a digital patient information letter. Patients and outcome assessors were blinded to group allocation.
PRIMARY AND SECONDARY OUTCOME MEASURES
The primary outcome was back pain beliefs. Secondary outcome measures were disability and absenteeism, and for the preplanned economic evaluation quality of life and societal costs were measured.
RESULTS
There were no between-group differences in back pain beliefs, disability, or absenteeism. Mean intervention costs were €70- and the societal cost difference was €535-in favour of the intervention group, but no significant cost savings were found. The incremental cost-effectiveness ratio indicated that the intervention dominated usual care and the probability of cost-effectiveness was 0.85 on a willingness-to-pay of €10.000/quality adjusted life year (QALY).
CONCLUSIONS
A multifaceted eHealth strategy was not effective in improving patients' back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs.
TRIAL REGISTRATION NUMBER
NTR4329.",2019,"A multifaceted eHealth strategy was not effective in improving patients' back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs.
","['Patients diagnosed with non-specific low back pain by their general practitioner or physiotherapist', '779 patients were randomised into intervention group (n=331, 59% female; 60.4% completed study) or control group (n=448, 57% female; 77.5% completed study', 'Dutch primary healthcare', 'Patients with serious comorbidities or confirmed pregnancy were excluded', 'patients with non-specific low back pain']","['multifaceted eHealth strategy', 'multifaceted eHealth strategy that included a (mobile) website, digital monthly newsletters, and social media platforms']","['cost savings', 'back pain beliefs, disability, or absenteeism', ""patients' back pain beliefs"", 'Effectiveness and cost-utility', 'probability of cost-effectiveness', 'disability and absenteeism, and for the preplanned economic evaluation quality of life and societal costs', 'Mean intervention costs', 'back pain beliefs', 'incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",779.0,0.179204,"A multifaceted eHealth strategy was not effective in improving patients' back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs.
","[{'ForeName': 'Arnela', 'Initials': 'A', 'LastName': 'Suman', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam UMC - Locatie VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Frederieke G', 'Initials': 'FG', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam UMC - Locatie VUMC, Amsterdam, The Netherlands f.schaafsma@vumc.nl.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Petra J M', 'Initials': 'PJM', 'LastName': 'Elders', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam UMC - Locatie VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Department of Clinical Epidemiology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Anema', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam UMC - Locatie VUMC, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-030879']
991,31811007,"COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial.","INTRODUCTION
Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH). However, the surgery leads to bony defects in the skull with skin depressions above that are frequently considered aesthetically unsatisfactory by the patients. Those defects could be covered by the approved medical devices (burr hole covers), but this is rarely done today. We wish to assess, whether the application of burr hole covers after trepanation for the evacuation of cSDH leads to higher patient satisfaction with the aesthetical result at 90 days postoperative, without worsening disability outcomes or increasing the complication rate.
METHODS AND ANALYSIS
This is a prospective, single-blinded, randomised, controlled, investigator-initiated clinical trial enrolling 80 adult patients with first-time unilateral or bilateral cSDH in Switzerland. The primary outcome is the difference in satisfaction with the aesthetic result of the scar, comparing patients allocated to the intervention (burr hole cover) and control (no burr hole cover) group, measured on the Aesthetic Numeric Analogue scale at 90 days postoperative. Secondary outcomes include differences in the rates of skin depression, complications, as well as neurological, disability and health-related quality of life outcomes until 12 months postoperative.
ETHICS AND DISSEMINATION
The institutional review board (Kantonale Ethikkommission Zürich) approved this study on 29 January 2019 under case number BASEC 2018-01180. This study determines, whether a relatively minor modification of a standard surgical procedure can improve patient satisfaction, without worsening functional outcomes or increasing the complication rate. The outcome corresponds to the value-based medicine approach of modern patient-centred medicine. Results will be published in peer-reviewed journals and electronic patient data will be safely stored for 15 years.
TRIAL REGISTRATION NUMBER
NCT03755349.",2019,"INTRODUCTION
Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH).","['80 adult patients with first-time unilateral or bilateral cSDH in Switzerland', '29 January 2019 under case number BASEC 2018-01180']",[],"['rates of skin depression, complications, as well as neurological, disability and health-related quality of life outcomes until 12 months postoperative', 'complication rate', 'satisfaction with the aesthetic result of the scar', 'Aesthetic Numeric Analogue scale', 'patient satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",[],"[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0222045'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",80.0,0.160525,"INTRODUCTION
Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH).","[{'ForeName': 'Martin N', 'Initials': 'MN', 'LastName': 'Stienen', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland mnstienen@gmail.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Akeret', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Vasella', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Velz', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Jehli', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Scheffler', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Voglis', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bichsel', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Nicolas Roydon', 'Initials': 'NR', 'LastName': 'Smoll', 'Affiliation': 'School of Population and Global Health, University of Melbourne, Melbourne, Sydney, Australia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bozinov', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Regli', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Menno R', 'Initials': 'MR', 'LastName': 'Germans', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-031375']
992,31860366,A week-long outpatient induction onto XR-naltrexone in patients with opioid use disorder.,"BACKGROUND
Extended-release (XR) naltrexone can prevent relapse to opioid use disorder following detoxification. However, one of the barriers to initiating XR-naltrexone is the recommendation for a 7-10-day period of abstinence from opioids prior to the first dose.
OBJECTIVES
The current study evaluated the feasibility of an XR-naltrexone induction protocol that can be implemented over 1 week in the outpatient clinic.
METHODS
Participants (N = 44) were seen in the clinic daily. On Day 1, after abstaining from opioids for at least 12 h, they received buprenorphine 6-8 mg. Adjunctive medications (clonidine, clonazepam, zolpidem, trazodone, and prochlorperazine) were dispensed on Days 2-5, while ascending oral doses of naltrexone were given on Days 3-5 starting with 1 mg dose. An injection of XR-naltrexone was given on Day 5, 1 h after receiving and tolerating naltrexone 24 mg.
RESULTS
Of the 44 participants (38 males), 35 (80%) were heroin users and 9 (20%) used prescription opioids. A total of 26 participants (59%) completed the induction and received their first injection of XR-naltrexone. XR-naltrexone was initiated in 54% (19/35) of heroin users and 78% (7/9) of prescription opioid users.
CONCLUSION
The results support the feasibility of a week-long outpatient induction onto XR-naltrexone with ascending doses of naltrexone and standing doses of adjunctive medications. By circumventing the need for a protracted period of abstinence and mitigating the severity of withdrawal symptoms experienced during naltrexone titration, this strategy has the potential to increase patient acceptability and access to relapse prevention treatment with XR-naltrexone.",2020,XR-naltrexone was initiated in 54% (19/35) of heroin users and 78% (7/9) of prescription opioid users.,"['patients with opioid use disorder', '44 participants (38 males), 35 (80%) were heroin users and 9 (20%) used prescription opioids']","['release (XR) naltrexone', 'XR-naltrexone induction protocol', 'XR-naltrexone', 'buprenorphine', 'Adjunctive medications (clonidine, clonazepam, zolpidem, trazodone, and prochlorperazine', 'naltrexone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0009011', 'cui_str': 'Clonazepam'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}]",[],26.0,0.0269508,XR-naltrexone was initiated in 54% (19/35) of heroin users and 78% (7/9) of prescription opioid users.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sibai', 'Affiliation': 'Department of Psychology, University of Detroit Mercy , Detroit, MI, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Mishlen', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bisaga', 'Affiliation': 'Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2019.1700265']
993,31747035,Augmentation of Positive Valence System-Focused Cognitive Behavioral Therapy by Inaudible High-Frequency Sounds for Anhedonia: A Trial Protocol for a Pilot Study.,"Importance
Recent conceptualizations in Research Domain Criteria have indicated that anhedonia, 1 of 2 core symptoms of depression, which can be treatment resistant, is associated with deficits in the positive valence system, and inaudible high-frequency sound therapy has been shown to enhance reward-related brain circuitry. Hence, cognitive behavioral therapy focusing on the positive valence system enhanced with sound therapy could have a synergistic effect on anhedonia.
Objective
To test the augmentation effect of inaudible high-frequency sounds on the efficacy of positive valence system-focused cognitive behavioral therapy to treat anhedonia.
Design, Setting, and Participants
In this individual-level allocation, exploratory, single-center randomized superiority pilot trial, patients, therapists, and evaluators will be masked to intervention or placebo assignment. The trial will take place at a national psychiatric referral hospital in Tokyo, Japan, among 44 adult patients with clinically significant anhedonia and moderate to severe depression. Outcomes will be analyzed following the intent-to-treat principle using a repeated-measures mixed model.
Intervention
The intervention group will participate in 8 weekly sessions of positive valence system-focused cognitive behavioral therapy with in-session exposure to an inaudible high-frequency sound; the comparison group will undergo cognitive behavioral therapy with in-session exposure to a placebo sound.
Main Outcomes and Measures
The primary outcome is anhedonia assessed using the self-reported Snaith-Hamilton Pleasure Scale. The secondary outcome is anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale.
Discussion
Recruitment for this study began in May 2018, and the projected date of final allocation is January 2020. A total of 21 eligible patients were registered for participation as of May 30, 2019. To date, treatments for depression do not guarantee clinically successful outcomes. This pilot trial will provide preliminary evidence of the augmentation effect of high-frequency inaudible sounds on cognitive behavioral therapy for anhedonia. Overall, exposure to an inaudible high-frequency sounds does not require attentional or cognitive effort from either patients or therapists; therefore, results from a future confirmative trial could indicate that cognitive behavioral therapy can be augmented in an effortless manner.
Trial Registration
umin.ac.jp/ctr Identifier: UMIN000031948.",2019,"The secondary outcome is anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale.
","['44 adult patients with clinically significant anhedonia and moderate to severe depression', 'Anhedonia', '21 eligible patients were registered for participation as of May 30, 2019']","['Positive Valence System', 'positive valence system-focused cognitive behavioral therapy with in-session exposure to an inaudible high-frequency sound; the comparison group will undergo cognitive behavioral therapy with in-session exposure to a placebo sound', 'Focused Cognitive Behavioral Therapy', 'positive valence system-focused cognitive behavioral therapy']","['anhedonia assessed using the self-reported Snaith-Hamilton Pleasure Scale', 'anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0222045'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]",44.0,0.0992092,"The secondary outcome is anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale.
","[{'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Miyamae', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Yokoyama', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Information Medicine, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ueno', 'Affiliation': 'Department of Information Medicine, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Maruo', 'Affiliation': 'University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Asami', 'Initials': 'A', 'LastName': 'Komazawa', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Niwa', 'Affiliation': 'National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Honda', 'Affiliation': 'Department of Information Medicine, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Horikoshi', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.15819']
994,31752370,"Effect of Lactobacillus plantarum TWK10 on Exercise Physiological Adaptation, Performance, and Body Composition in Healthy Humans.","Probiotics have been rapidly developed for health promotion, but clinical validation of the effects on exercise physiology has been limited. In a previous study, Lactobacillus plantarum TWK10 (TWK10), isolated from Taiwanese pickled cabbage as a probiotic, was demonstrated to improve exercise performance in an animal model. Thus, in the current study, we attempted to further validate the physiological function and benefits through clinical trials for the purpose of translational research. The study was designed as a double-blind placebo-controlled experiment. A total of 54 healthy participants (27 men and 27 women) aged 20-30 years without professional athletic training were enrolled and randomly allocated to the placebo, low (3 × 10 10 colony forming units (CFU)), and high dose (9 × 10 10 CFU) TWK10 administration groups ( n = 18 per group, with equal sexes). The functional and physiological assessments were conducted by exhaustive treadmill exercise measurements (85% VO 2max ), and related biochemical indices were measured before and after six weeks of administration. Fatigue-associated indices, including lactic acid, blood ammonia, blood glucose, and creatinine kinase, were continuously monitored during 30 min of exercise and a 90 min rest period using fixed intensity exercise challenges (60% VO 2max ) to understand the physiological adaptation. The systemic inflammation and body compositions were also acquired and analyzed during the experimental process. The results showed that TWK10 significantly elevated the exercise performance in a dose-dependent manner and improved the fatigue-associated features correlated with better physiological adaptation. The change in body composition shifted in the healthy direction for TWK10 administration groups, especially for the high TWK10 dose group, which showed that body fat significantly decreased and muscle mass significantly increased. Taken together, our results suggest that TWK10 has the potential to be an ergogenic aid to improve aerobic endurance performance via physiological adaptation effects.",2019,The results showed that TWK10 significantly elevated the exercise performance in a dose-dependent manner and improved the fatigue-associated features correlated with better physiological adaptation.,"['54 healthy participants (27 men and 27 women) aged 20-30 years without professional athletic training', 'Healthy Humans']","['placebo', 'placebo, low (3 × 10 10 colony forming units (CFU)), and high dose (9 × 10 10 CFU', 'Lactobacillus plantarum', 'TWK10']","['aerobic endurance performance', 'Fatigue-associated indices, including lactic acid, blood ammonia, blood glucose, and creatinine kinase', 'body composition', 'systemic inflammation and body compositions', 'Exercise Physiological Adaptation, Performance, and Body Composition', 'exercise performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}, {'cui': 'C0005768'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001400', 'cui_str': 'Adaptations, Physiologic'}]",54.0,0.0670137,The results showed that TWK10 significantly elevated the exercise performance in a dose-dependent manner and improved the fatigue-associated features correlated with better physiological adaptation.,"[{'ForeName': 'Wen-Ching', 'Initials': 'WC', 'LastName': 'Huang', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei 11219, Taiwan.'}, {'ForeName': 'Mon-Chien', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 33301, Taiwan.'}, {'ForeName': 'Chia-Chia', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Culture Collection & Research Institute, SYNBIO TECH INC., Kaohsiung 82151, Taiwan.'}, {'ForeName': 'Ker-Sin', 'Initials': 'KS', 'LastName': 'Ng', 'Affiliation': 'Culture Collection & Research Institute, SYNBIO TECH INC., Kaohsiung 82151, Taiwan.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 33301, Taiwan.'}, {'ForeName': 'Tsung-Yu', 'Initials': 'TY', 'LastName': 'Tsai', 'Affiliation': 'Department of Food Science, Fu Jen Catholic University, New Taipei City 24205, Taiwan.'}, {'ForeName': 'San-Land', 'Initials': 'SL', 'LastName': 'Young', 'Affiliation': 'Culture Collection & Research Institute, SYNBIO TECH INC., Kaohsiung 82151, Taiwan.'}, {'ForeName': 'Jin-Seng', 'Initials': 'JS', 'LastName': 'Lin', 'Affiliation': 'Culture Collection & Research Institute, SYNBIO TECH INC., Kaohsiung 82151, Taiwan.'}, {'ForeName': 'Chi-Chang', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan 33301, Taiwan.'}]",Nutrients,['10.3390/nu11112836']
995,31771890,Transradial and Transfemoral Uterine Fibroid Embolization Comparative Study: Technical and Clinical Outcomes.,"PURPOSE
To compare clinical and technical outcomes of transradial (TRA) uterine artery embolization (UAE) with those of the transfemoral (TFA) approach.
MATERIALS AND METHODS
Consecutive patients who underwent UAE with TRA and TFA in an academic hospital between May 2014 and June 2018 were included in this study. The ability to perform the procedure as planned, complication rates, and reduction in uterine volume, fibroid enhancement, and symptomatic improvement were compared using descriptive statistics, Student t-test, and chi-square test.
RESULTS
There were 91 patients in the TFA group and 91 patients in the TRA group, with 1 crossover to TFA due to vasospasm (1 of 91; 1%). The tallest patient in the TRA UAE group was 178 cm and 4 patients taller than 178 cm in the TFA UAE group. Larger particles (900-1,200 μm) were more often used in the TFA group than in the TRA group (P < .001). There were similar low rates of minor access site complications. In the TFA group (6 of 91, 7%), 5 patients had groin hematomas, and 2 patients had groin pain compared to the TRA group (5 of 91, 5%): in which 4 patients had transient focal occlusion of the radial artery and 1 patient had focal pain, all of which resolved with conservative management. There were similar rates of uterine volume reduction in 40% ± 17% in the TFA versus 36% ± 16% in the TRA group (P = .22) and no residual enhancement in 49 of 58 [84%] in the TFA group versus 66 of 77 [86%] in the TRA group (P = .84). There were similar reductions in modifying symptoms (60 of 64 [94%] in the TRA group; and 37 of 40 [93%] in the TFA group; P = NS) was noted at follow-up.
CONCLUSIONS
Transradial UAE in women up to 178 cm tall and transfemoral UAE have similar technical and clinical outcomes, with low rates of access site complications.",2020,There were similar rates of uterine volume reduction in 40% ± 17% in the TFA versus 36% ± 16% in the TRA group (P = .22) and no residual enhancement in 49 of 58 [84%] in the TFA group versus 66 of 77 [86%] in the TRA group (P = .84).,['Consecutive patients who underwent UAE with TRA and TFA in an academic hospital between May 2014 and June 2018 were included in this study'],"['TFA', 'Transradial UAE', 'TRA', 'transradial (TRA) uterine artery embolization (UAE', 'TFA UAE', 'TRA UAE']","['groin pain', 'focal pain', 'residual enhancement', 'transient focal occlusion', 'rates of uterine volume reduction', 'modifying symptoms', 'groin hematomas', 'complication rates, and reduction in uterine volume, fibroid enhancement, and symptomatic improvement', 'vasospasm']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0729536', 'cui_str': 'Uterine Artery Embolization'}]","[{'cui': 'C0239783', 'cui_str': 'Inguinal pain (finding)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0085616', 'cui_str': 'Vasospasm (finding)'}]",2018.0,0.0670236,There were similar rates of uterine volume reduction in 40% ± 17% in the TFA versus 36% ± 16% in the TRA group (P = .22) and no residual enhancement in 49 of 58 [84%] in the TFA group versus 66 of 77 [86%] in the TRA group (P = .84).,"[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Nakhaei', 'Affiliation': 'Department of Radiology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215; Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mojtahedi', 'Affiliation': 'Department of Radiology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215; Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Salomao', 'Initials': 'S', 'LastName': 'Faintuch', 'Affiliation': 'Department of Radiology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215; Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Sarwar', 'Affiliation': 'Department of Radiology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215; Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Olga R', 'Initials': 'OR', 'LastName': 'Brook', 'Affiliation': 'Department of Radiology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215; Harvard Medical School, Boston, Massachusetts. Electronic address: obrook@bidmc.harvard.edu.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.08.016']
996,31310038,Fluoroscopy-guided axillary vein access vs cephalic vein access in pacemaker and defibrillator implantation: Randomized clinical trial of efficacy and safety.,"INTRODUCTION
The most widespread venous sites of access for implantation intravenous implantable cardiac electronic device (CIED) are the cephalic and subclavian vein. Fluoroscopy-guided axillary venous access is an alternative, but efficacy and safety have not been studied under equal conditions. The aim of the present study is to compare the efficacy and safety of fluoroscopy-guided axillary vs cephalic vein access in CIED implant.
METHODS AND RESULTS
Two hundred and forty patients were randomized to receive CIED implantation by the fluoroscopy-guided axillary vein access vs cephalic vein access. The implantation success, the procedure times and the complications were recorded. A comparison of the results of operators was made. The success rate of the randomized venous access was superior in the axillary group than in cephalic (98.3% vs 76.7%, P < .001). Time to access (6.8 ± 3.1 minute vs 13.1 ± 5.8 minutes, P < .001) and implantation duration was significantly shorter in the axillary group than in the cephalic group (42.3 ± 11.6 minutes vs 50.5 ± 13.3 minutes, P < .001). There was no difference in the incidence of complication and inter-operator success rate, complications rate and time to access.
CONCLUSION
The fluoroscopy-guided axillary venous access is safe and has a better success rate and faster execution time compared with the cephalic vein access. When the results were compared among the study operators, neither in the axillary nor in the cephalic group there were differences in the success rate, the complication rate, and the time to access.
TRIAL REGISTRATION
www.clinicaltrials.gov, NCT03860090.",2019,The fluoroscopy-guided axillary venous access is safe and has a better success rate and faster execution time compared with the cephalic vein access.,"['pacemaker and defibrillator implantation', 'Two hundred and forty patients']","['fluoroscopy-guided axillary vs cephalic vein access', 'Fluoroscopy-guided axillary venous access', 'CIED implantation by the fluoroscopy-guided axillary vein access vs cephalic vein access', 'Fluoroscopy-guided axillary vein access vs cephalic vein access']","['implantation success, the procedure times and the complications', 'incidence of complication and inter-operator success rate, complications rate and time to access', 'success rate', 'implantation duration', 'efficacy and safety', 'success rate, the complication rate, and the time to access']","[{'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0004456', 'cui_str': 'Axillary Vein'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",240.0,0.115574,The fluoroscopy-guided axillary venous access is safe and has a better success rate and faster execution time compared with the cephalic vein access.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Jiménez-Díaz', 'Affiliation': 'Arrhythmia Unit, Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Higuera-Sobrino', 'Affiliation': 'Arrhythmia Unit, Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Piqueras-Flores', 'Affiliation': 'Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Díaz', 'Affiliation': 'Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'María Arantzazu', 'Initials': 'MA', 'LastName': 'González-Marín', 'Affiliation': 'Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14060']
997,31350765,The effects and cost-effectiveness of an empowerment-based self-care programme in patients with chronic heart failure: A study protocol.,"AIM
This study aims to evaluate the effects of a 12-week empowerment-based self-care programme on the cognitive, psychological and behavioural aspects of self-care, health-related quality of life and unplanned hospital service use of chronic heart failure patients and to estimate its cost-effectiveness in reducing unplanned service use.
STUDY DESIGN
Randomized controlled trial with cost-effectiveness analysis.
METHODS
The study will recruit 236 community-dwelling Chinese patients with chronic heart failure from regional hospitals in Hong Kong. Patients will be randomized in blocks to attend either the 12-week empowerment-based self-care programme or a didactic education programme. Central to the empowerment-based model is that the patients are the primary decision makers in self-care and act autonomously to manage the disease. Collaborative approach and interactive teaching strategies are used to optimize patients' engagement and knowledge translation to real-life practice. Outcome evaluation on self-care maintenance and management, symptom perception, self-care confidence, self-care knowledge, health-related quality of life and health service use will take place at baseline, on completion of the programme and at 12 weeks thereafter. Generalized estimating equations and Cox regression examine the intervention effects. Bootstrapping technique will be conducted to examine the cost-effectiveness of the intervention. The study is formally funded in December 2016.
DISCUSSION
Chronic heart failure is associated with high level of hospital admissions, of which 40% is avoidable through effective self-care. Although self-care confidence is known to improve self-care, no structured educative method has been developed to enhance this attribute. This study addresses this research gap with a stringent application of theory and research design.
IMPACT
The study illustrates the application of the empowerment model for self-care enhancement in patients with chronic heart failure. The findings will inform the ways and values of this care model to enhance the disease management of this expanding clinical cohort.",2019,"Outcome evaluation on self-care maintenance and management, symptom perception, self-care confidence, self-care knowledge, health-related quality of life and health service use will take place at baseline, on completion of the programme and at 12 weeks thereafter.","['236 community-dwelling Chinese patients with chronic heart failure from regional hospitals in Hong Kong', 'patients with chronic heart failure', 'chronic heart failure patients']","['12-week empowerment-based self-care programme', '12-week empowerment-based self-care programme or a didactic education programme', 'empowerment-based self-care programme']","['self-care maintenance and management, symptom perception, self-care confidence, self-care knowledge, health-related quality of life and health service use will take place at baseline, on completion of the programme']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]",236.0,0.0404357,"Outcome evaluation on self-care maintenance and management, symptom perception, self-care confidence, self-care knowledge, health-related quality of life and health service use will take place at baseline, on completion of the programme and at 12 weeks thereafter.","[{'ForeName': 'Doris S F', 'Initials': 'DSF', 'LastName': 'Yu', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Polly W C', 'Initials': 'PWC', 'LastName': 'Li', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Sunny C S', 'Initials': 'SCS', 'LastName': 'Yue', 'Affiliation': 'Department of Medicine and Geriatrics, United Christian Hospital, Kwun Tong, Hong Kong.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Division of Cardiology, Department of Medicine and Geriatrics, Tseung Kwan O Hospital, Tseung Kwan O, Hong Kong.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Kin Keung', 'Initials': 'KK', 'LastName': 'Tsang', 'Affiliation': 'Private Cardiac Clinic, Hong Kong.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, Hong Kong.'}]",Journal of advanced nursing,['10.1111/jan.14162']
998,31739213,The effects of foot reflexology on back pain after coronary angiography: A randomized controlled trial.,"BACKGROUND AND AIMS
Back pain is among the most common complaints of patients during the first hours after coronary angiography (CA), i.e. when they are restricted to complete bed rest. This study aimed to evaluate the effects of foot reflexology on back pain after CA.
METHODS
This randomized controlled trial was conducted in 2018-2019 on patients hospitalized in the post-angiography unit of Razi hospital, Birjand, Iran. Through convenience sampling, 120 patients were recruited and their demographic characteristics and baseline back pain intensity were assessed immediately after angiography using a demographic questionnaire and a visual analogue scale, respectively. Then, patients were randomly allocated to a control (n = 60) and a reflexology (n = 60) group through block randomization. Patients in the reflexology group received 8-min foot reflexology for each foot (16 min for both feet) while their counterparts in the control group solely received routine post-angiography care services. Back pain assessment was repeated for all participants immediately, two, four, and 6 h after the intervention. Data were analyzed using the SPSS software (v. 16.0).
FINDINGS
Back pain intensity significantly increased after angiography in both groups (P < 0.05). Yet, pain intensity in the reflexology group at all post-intervention measurement time points was significantly less than the control group (P < 0.001).
CONCLUSION
Foot reflexology is effective in significantly reducing back pain after CA.",2020,"FINDINGS
Back pain intensity significantly increased after angiography in both groups (P < 0.05).","['2018-2019 on patients hospitalized in the post-angiography unit of Razi hospital, Birjand, Iran', 'back pain after coronary angiography', '120 patients were recruited and their']","['8-min foot reflexology', 'control group solely received routine post-angiography care services', 'foot reflexology', 'reflexology (n\u202f=\u202f60) group through block randomization']","['Back pain assessment', 'demographic characteristics and baseline back pain intensity', 'pain intensity', 'back pain', 'Back pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",120.0,0.0707258,"FINDINGS
Back pain intensity significantly increased after angiography in both groups (P < 0.05).","[{'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Kardan', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Birjand University of Medical Sciences, Birjand, Iran. Electronic address: mo.kardan54@gmail.com.'}, {'ForeName': 'Bahare', 'Initials': 'B', 'LastName': 'Zarei', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Birjand University of Medical Sciences, Birjand, Iran. Electronic address: Baharezarei@bums.ac.ir.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'BahramiTaghanaki', 'Affiliation': 'Department of Chinese and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: Bahramihr@mums.ac.ir.'}, {'ForeName': 'Seyyed Abolfazl', 'Initials': 'SA', 'LastName': 'Vagharseyyedin', 'Affiliation': 'Faculty of Nursing and Midwifery College, Birjand University of Medical Sciences, Birjand, Iran. Electronic address: Waghars@bums.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Azdaki', 'Affiliation': 'Department of Cardiology, School of Medicine, Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran. Electronic address: Nahidazdaki@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2019.101068']
999,31806605,Rituximab versus steroids and cyclophosphamide for the treatment of primary membranous nephropathy: protocol of a pilot randomised controlled trial.,"INTRODUCTION
Primary membranous nephropathy (MN) is a common cause of nephrotic syndrome in adults. The disease may have different long-term outcomes. After 10 years of follow-up, 35%-50% of the untreated patients with persistent nephrotic syndrome may die or progress to end stage renal disease. The 2012 KDIGO (Kidney Disease Improving Global Outcomes) guidelines recommend that initial therapy should consist of alternating steroids and an alkylating agent for 6 months. Recent observational studies showed that the anti-CD20 antibody rituximab may be effective in inducing remission. We designed a pilot multicentre randomised trial to inform the design of a larger trial testing the efficacy and safety of treatment with steroids and cyclophosphamide versus rituximab in patients with primary MN and heavy proteinuria (>3.5 g/24 hours).
METHODS AND ANALYSIS
This pilot, open-label, two-parallel-arm, randomised clinical trial will enrol 70 patients with primary MN and heavy proteinuria. Patients will be randomised in a 1:1 ratio to either the intervention arm (rituximab) or the active comparator arm (corticosteroid/alkylating-agent therapy). The study will provide estimates of the probability of complete remission of proteinuria and risk of serious side effects at 12 months to inform the design of a larger trial. We will also assess the recruitment potential of each participating centre to address study feasibility.
ETHICS AND DISSEMINATION
The trial received ethics approval from the local ethics boards. We will publish pilot data to inform the design of a larger clinical trial.
TRIAL REGISTRATION NUMBERS
NCT03018535; 2011-006115-59.",2019,"We designed a pilot multicentre randomised trial to inform the design of a larger trial testing the efficacy and safety of treatment with steroids and cyclophosphamide versus rituximab in patients with primary MN and heavy proteinuria (>3.5 g/24 hours).
","['patients with primary MN and heavy proteinuria (>3.5\u2009g/24\u2009hours', 'primary membranous nephropathy', '70 patients with primary MN and heavy proteinuria', 'nephrotic syndrome in adults']","['intervention arm (rituximab) or the active comparator arm (corticosteroid/alkylating-agent therapy', 'steroids and cyclophosphamide versus rituximab', 'Rituximab versus steroids and cyclophosphamide']",['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0017665', 'cui_str': 'Membranous Glomerulonephropathy'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0002073', 'cui_str': 'Alkylators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",70.0,0.196113,"We designed a pilot multicentre randomised trial to inform the design of a larger trial testing the efficacy and safety of treatment with steroids and cyclophosphamide versus rituximab in patients with primary MN and heavy proteinuria (>3.5 g/24 hours).
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Scolari', 'Affiliation': 'Dipartimento di Specialità Medico-Chirurgiche, Scienze Radiologiche e Sanità Pubblica, Università di Brescia, Brescia, Italy ceccoscolari@gmail.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dallera', 'Affiliation': 'Dipartimento di Specialità Medico-Chirurgiche, Scienze Radiologiche e Sanità Pubblica, Università di Brescia, Brescia, Italy.'}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Gesualdo', 'Affiliation': 'Division of Nephroplogy, Universita degli Studi di Bari Aldo Moro, Bari, Puglia, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Santoro', 'Affiliation': 'Division of Nephrology, Universita degli Studi di Messina, Messina, Sicilia, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Pani', 'Affiliation': 'Division of Nephrology, Ospedale Brotzu, Cagliari, Italy.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Santostefano', 'Affiliation': ""Division of Nephrology, Ospedale Sant'Orsola-Malpighi, Bologna, Italy.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Feriozzi', 'Affiliation': 'Division of Nephrology, Ospedale di Viterbo, Viterbo, Italy.'}, {'ForeName': 'Laila-Yasmin', 'Initials': 'LY', 'LastName': 'Mani', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital Universitatsspital Bern, Bern, Switzerland.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Boscutti', 'Affiliation': 'Nefrologia e Dialisi, Azienda Sanitaria Universitaria Integrata di Trieste, Trieste, Italy.'}, {'ForeName': 'Piergiorgio', 'Initials': 'P', 'LastName': 'Messa', 'Affiliation': 'Maggiore Hospital and IRCCS Foundation, Milano, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Magistroni', 'Affiliation': 'Universita degli Studi di Modena e Reggio Emilia Dipartimento di Scienze della Vita, Modena, Emilia-Romagna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Quaglia', 'Affiliation': 'Division of Nephrology, Universita degli Studi del Piemonte Orientale Amedeo Avogadro, Vercelli, Piemonte, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Ponticelli', 'Affiliation': 'Division of Nephrology, (past Director), Ospedale Maggiore Policlinico, Milano, Lombardia, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ravani', 'Affiliation': 'Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-029232']
1000,31872408,A controlled randomized trial about using a checklist-based critical appraisal.,"BACKGROUND
the critical appraisal of scientific publications is a mainstay step in the evidence-based-practice. This study aimed to assess the utility of using a checklist in implementing this practice.
METHODS
medical students in the third year that were performing a training period in a department of pathology were randomly assigned to two groups. A computerized random number allocation was used. The same manuscript was given to both groups. All the students spent the same period of training in the department and they received the same training session about critical appraisal of scientific publications. The intervention group (n=26) performed a critical appraisal of the article using the checklist of a Pubmed-indexed journal and the control group (n=25) performed a free critical appraisal. The individual critical appraisal forms were evaluated using a scoring-based-checklist. A one-way ANOVA test was used to compare the scores between both groups using SPSS software (version 11.0).
RESULTS
51 students were enrolled in this study. The mean score of the participants using free appraisal reached 16.5 in men and 13.25 in women. The mean scores in the intervention group reached 14.83 in men and 14.75 in women. The mean scores in the control group reached 13.65 and 14.42 in the intervention group (p=0.61).
CONCLUSION
these results highlighted the absence of significant difference in critical appraisal skills when using or not a checklist. This result has to be taken with caution because all the participants received the same training methods during the same period.",2019,"The mean scores in the control group reached 13.65 and 14.42 in the intervention group (p=0.61).
","['medical students in the third year that were performing a training period in a department of pathology', '51 students']",['critical appraisal of the article using the checklist of a Pubmed-indexed journal and the control group (n=25) performed a free critical appraisal'],['mean scores'],"[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0220932,"The mean scores in the control group reached 13.65 and 14.42 in the intervention group (p=0.61).
","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Mlika', 'Affiliation': ''}, {'ForeName': 'Chadli', 'Initials': 'C', 'LastName': 'Dziri', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ben Khelil', 'Affiliation': ''}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Zakhama', 'Affiliation': ''}, {'ForeName': 'Faouzi', 'Initials': 'F', 'LastName': 'Mezni', 'Affiliation': ''}]",La Tunisie medicale,[]
1001,31744119,Sub-Chronic Consumption of Dark Chocolate Enhances Cognitive Function and Releases Nerve Growth Factors: A Parallel-Group Randomized Trial.,"Previous research has shown that habitual chocolate intake is related to cognitive performance and that frequent chocolate consumption is significantly associated with improved memory. However, little is known about the effects of the subchronic consumption of dark chocolate (DC) on cognitive function and neurotrophins. Eighteen healthy young subjects (both sexes; 20-31 years old) were randomly divided into two groups: a DC intake group ( n = 10) and a cacao-free white chocolate (WC) intake group ( n = 8). The subjects then consumed chocolate daily for 30 days. Blood samples were taken to measure plasma levels of theobromine (a methylxanthine most often present in DC), nerve growth factor (NGF), and brain-derived neurotrophic factor, and to analyze hemodynamic parameters. Cognitive function was assessed using a modified Stroop color word test and digital cancellation test. Prefrontal cerebral blood flow was measured during the tests. DC consumption increased the NGF and theobromine levels in plasma, enhancing cognitive function performance in both tests. Interestingly, the DC-mediated enhancement of cognitive function was observed three weeks after the end of chocolate intake. WC consumption did not affect NGF and theobromine levels or cognitive performance. These results suggest that DC consumption has beneficial effects on human health by enhancing cognitive function.",2019,WC consumption did not affect NGF and theobromine levels or cognitive performance.,['Eighteen healthy young subjects (both sexes; 20-31 years old'],"['DC intake group ( n = 10) and a cacao-free white chocolate (WC) intake group', 'DC consumption', 'Sub-Chronic Consumption of Dark Chocolate Enhances Cognitive Function and Releases Nerve Growth Factors']","['Prefrontal cerebral blood flow', 'cognitive function', 'NGF and theobromine levels or cognitive performance', 'NGF and theobromine levels in plasma, enhancing cognitive function performance', 'nerve growth factor (NGF), and brain-derived neurotrophic factor', 'Cognitive function']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0006622', 'cui_str': 'Cocoa Plant'}, {'cui': 'C0453439', 'cui_str': 'White chocolate (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3853217', 'cui_str': 'Dark chocolate (substance)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}]","[{'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0039763', 'cui_str': 'Theobromine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]",18.0,0.0147324,WC consumption did not affect NGF and theobromine levels or cognitive performance.,"[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Sumiyoshi', 'Affiliation': 'Department of Environmental Physiology, Faculty of Medicine, Shimane University, Izumo 693-8501, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Matsuzaki', 'Affiliation': 'Department of Environmental Physiology, Faculty of Medicine, Shimane University, Izumo 693-8501, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Environmental Physiology, Faculty of Medicine, Shimane University, Izumo 693-8501, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tanabe', 'Affiliation': 'Department of Environmental Physiology, Faculty of Medicine, Shimane University, Izumo 693-8501, Japan.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Hara', 'Affiliation': 'Department of Environmental Physiology, Faculty of Medicine, Shimane University, Izumo 693-8501, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Katakura', 'Affiliation': 'Department of Nutritional Physiology, Faculty of Pharmaceutical Sciences, Josai University, Sakado 350-0295, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Miyamoto', 'Affiliation': 'School of Nursing, Faculty of Medicine, Shimane University, Izumo 693-8501, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Mishima', 'Affiliation': 'Central Clinical Laboratory, Shimane University Hospital, Izumo 693-8501, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Shido', 'Affiliation': 'Department of Environmental Physiology, Faculty of Medicine, Shimane University, Izumo 693-8501, Japan.'}]",Nutrients,['10.3390/nu11112800']
1002,31860110,Effect of Parental Counseling on Infants' Healthy Sleep Habits in Brazil: A Randomized Clinical Trial.,"Importance
Poor sleep during early childhood is associated with adverse outcomes, including obesity, cognitive impairment, and mental and behavioral disorders.
Objective
To assess the efficacy of an educational intervention in the promotion of nighttime sleep duration.
Design, Setting, and Participants
This single-blind, intent-to-treat randomized clinical trial included participants in Pelotas, Brazil, aged 3 months who were followed up until age 24 months. Eligibility criteria included healthy infants aged approximately 3 months who slept less than 15 hours per 24 hours. Infants were randomized to the intervention group or control group.
Interventions
Information on sleep characteristics, improvements in the environment, establishment of a nighttime sleep routine, and waiting before attending nocturnal awakenings was delivered to mothers in the intervention group by trained home-visitors at baseline. The intervention group received a telephone call on the first and second day after the intervention and a home visit on the third day after the intervention. The intervention's content was reinforced at health care visits for ages 6 months and 12 months. Mothers allocated to the control group were counseled on the benefits of breastfeeding for the mother's and child's health and given written material with content on breastfeeding.
Main Outcomes and Measures
Nighttime sleep duration was measured by interview and actigraphy at baseline and ages 6, 12, and 24 months and diaries at baseline and age 6 months. At ages 3 and 6 months, nighttime sleep self-regulation was calculated by subtracting nighttime sleep duration recorded by actigraphy from nighttime sleep duration recorded in the diaries and at ages 12 and 24 months by subtracting nighttime sleep duration recorded by actigraphy from nighttime sleep duration obtained by interview.
Results
Among 1812 mother-infant dyads invited to participate, 798 met the inclusion criteria and 586 agreed to participate. The intervention group included 298 infants (154 [52.9%] boys), and the control group included 288 infants (164 [58.2%] boys). At age 6 months, mean (SD) nighttime sleep duration recorded in diaries was 9.80 (1.85) hours in the intervention group and 9.49 (2.07) hours in the control group, a difference of 19 minutes longer for the intervention group. At age 12 months, mean (SD) nighttime sleep duration based on the Brief Infant Sleep Questionnaire was 8.43 (1.35) hours in the intervention group and 8.52 (1.35) hours in the control group, a difference of 5 minutes shorter for the intervention group. At age 24 months, compared with information from the interview, actigraphy records showed that children in the intervention group stayed awake at night without signalizing for a mean (SD) of 0.52 (2.52) hours, whereas children in the control group stayed awake at night without signalizing for a mean (SD) of 0.23 (2.43) hours. There were no statistically significant difference between groups in any of the sleep parameters investigated.
Conclusions and Relevance
This randomized clinical trial found that the educational intervention did not achieve longer nighttime sleep duration among infants in the intervention group.
Trial Registration
ClinicalTrials.gov identifier: NCT02788630.",2019,"There were no statistically significant difference between groups in any of the sleep parameters investigated.
","['participants in Pelotas, Brazil, aged 3 months who were followed up until age 24 months', '298 infants (154 [52.9%] boys), and the control group included 288 infants (164 [58.2%] boys', '1812 mother-infant dyads invited to participate, 798 met the inclusion criteria and 586 agreed to participate', ""Infants' Healthy Sleep Habits in Brazil"", 'Eligibility criteria included healthy infants aged approximately 3 months who slept less than 15 hours per 24 hours']","['educational intervention', 'intervention group or control group', 'Parental Counseling', ""breastfeeding for the mother's and child's health and given written material with content on breastfeeding"", 'telephone call']","['sleep characteristics, improvements in the environment, establishment of a nighttime sleep routine, and waiting before attending nocturnal awakenings', 'mean (SD) nighttime sleep duration based on the Brief Infant Sleep Questionnaire', 'mean (SD) nighttime sleep duration recorded in diaries', 'nighttime sleep self-regulation', 'Measures\n\n\nNighttime sleep duration', 'nighttime sleep duration']","[{'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0456696', 'cui_str': '/24h'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",1812.0,0.0716626,"There were no statistically significant difference between groups in any of the sleep parameters investigated.
","[{'ForeName': 'Iná S', 'Initials': 'IS', 'LastName': 'Santos', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Del-Ponte', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Tovo-Rodrigues', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Camila S', 'Initials': 'CS', 'LastName': 'Halal', 'Affiliation': ""Nossa Senhora da Conceição Children's Hospital, Brazilian Ministry of Health, Porto Alegre, Brazil.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matijasevich', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Suélen', 'Initials': 'S', 'LastName': 'Cruz', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Anselmi', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Mariângela Freitas', 'Initials': 'MF', 'LastName': 'Silveira', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Pedro R Curi', 'Initials': 'PRC', 'LastName': 'Hallal', 'Affiliation': 'Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Diego G', 'Initials': 'DG', 'LastName': 'Bassani', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, Research Institute, University of Toronto, Toronto, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18062']
1003,31842940,Health-related quality of life during early aggressive treatment in patients with polyarticular juvenile idiopathic arthritis: results from randomized controlled trial.,"BACKGROUND
Juvenile Idiopathic Arthritis (JIA) may cause significant impairment in health-related quality of life (HrQoL), despite effective therapies. The aim of this study was to assess HrQoL during first-year treatment in patients with new-onset polyarticular JIA, and to compare treatment strategies.
METHODS
In ACUTE-JIA Study, 60 patients with new-onset JIA were randomized to receive either infliximab with methotrexate (IFX+MTX); a triple therapy of methotrexate, hydroxychloroquine, and sulfasalazine (Triple); or methotrexate monotherapy (MTX). Efficacy was measured with American College of Rheumatology pediatric (ACRp) score, and juvenile arthritis disease activity score (JADAS). HrQoL was evaluated with Child Health Questionnaire (CHQ), which includes physical and psychosocial summary scores (PhS and PsS). Linear mixed models were utilized to compare groups over time.
RESULTS
In the whole group of 60 patients, mean physical summary score (PhS) improved from 26.2 (SD 8.7) at week 0 to 49.7 (SD 13.2) at week 54 (p=0.046). Mean improvement of PhS was 20.3 (95% CI -15.5 to 56.2); 22.6 (-19.5 to 64.7); and 26.6 (-12.1 to 65.3) in IFX+MTX, Triple, and MTX, respectively. Changes in psychosocial summary score (PsS) were smaller: from 51.0 (SD 8.5) to 54.7 (6.3) (p=0.019) in all patients. No differences between the three treatment groups were detected in either of the measures. In multivariate analyses, Child Health Assessment Questionnaire (CHAQ), pain VAS, and time spent in inactive disease contributed to improvement in PhS; gender and CHAQ to PsS.
CONCLUSIONS
HrQol improved during the first year on therapy for JIA irrespective of the treatment strategy. The timing of change in the different dimensions of HrQoL varied; improvement occurred earlier in physical than psychosocial domains of HrQol.
TRIAL REGISTRATION
This study was registered within the Hospital District of Helsinki and Uusimaa (http://www.hus.fi) clinical trials, number 211864 in October 2002, and later on with ClinicalTrials.gov, number NCT01015547.",2019,Changes in psychosocial summary score (PsS) were smaller: from 51.0 (SD 8.5) to 54.7 (6.3) (p=0.019) in all patients.,"['patients with new-onset polyarticular JIA', '60 patients with new-onset JIA', 'patients with polyarticular juvenile idiopathic arthritis', 'Hospital District of Helsinki and Uusimaa (http://www.hus.fi) clinical trials, number 211864 in October 2002, and later on with ClinicalTrials.gov, number NCT01015547']","['methotrexate, hydroxychloroquine, and sulfasalazine (Triple); or methotrexate monotherapy (MTX', 'infliximab with methotrexate (IFX+MTX']","['Child Health Assessment Questionnaire (CHAQ), pain VAS, and time spent in inactive disease', 'Child Health Questionnaire (CHQ), which includes physical and psychosocial summary scores (PhS and PsS', 'American College of Rheumatology pediatric (ACRp) score, and juvenile arthritis disease activity score (JADAS', 'Mean improvement of PhS', 'psychosocial summary score (PsS', 'Health-related quality of life', 'Efficacy', 'mean physical summary score (PhS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0240789', 'cui_str': 'Polyarticular (qualifier value)'}, {'cui': 'C4521004', 'cui_str': 'Polyarticular juvenile idiopathic arthritis (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3495559', 'cui_str': 'Arthritis, Juvenile Chronic'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",60.0,0.204488,Changes in psychosocial summary score (PsS) were smaller: from 51.0 (SD 8.5) to 54.7 (6.3) (p=0.019) in all patients.,"[{'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Tarkiainen', 'Affiliation': ""Children's Hospital, Helsinki University Central Hospital, Helsinki, Finland. maarit.tarkiainen@helsinki.fi.""}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Tynjälä', 'Affiliation': 'Poison Information Centre, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Vähäsalo', 'Affiliation': 'Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Kröger', 'Affiliation': 'Department of Pediatrics, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Aalto', 'Affiliation': ""Children's Hospital, Helsinki University Central Hospital, Helsinki, Finland.""}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Lahdenne', 'Affiliation': ""Children's Hospital, Helsinki University Central Hospital, Helsinki, Finland.""}]",Pediatric rheumatology online journal,['10.1186/s12969-019-0370-1']
1004,31117149,Electroacupuncture plus on-demand gastrocaine for refractory functional dyspepsia: Pragmatic randomized trial.,"BACKGROUND AND AIM
Treatment options for functional dyspepsia (FD) refractory to pharmacological treatments are limited but the effectiveness of electroacupuncture (EA) is uncertain. We assessed the effectiveness of EA combined with on-demand gastrocaine.
METHODS
We conducted a single-center, assessor-blind, randomized parallel-group 2-arm trial on Helicobacter pylori negative FD patients of the postprandial distress syndrome subtype refractory to proton pump inhibitor, prokinetics, or H 2 antagonists. Enrolled participants were block randomized in a 1:1 ratio, with concealed random sequence. The treatment and control groups both received on-demand gastrocaine for 12 weeks, but only those in treatment group were offered 20 sessions of EA over 10 weeks. The primary endpoint was the between-group difference in proportion of patients achieving adequate relief of symptoms at week 12.
RESULTS
Of 132 participants randomly assigned to EA plus on-demand gastrocaine (n = 66) or on-demand gastrocaine alone (n = 66), 125 (94.7%) completed all follow-up at 12 weeks. The EA group had a compliance rate 97.7%. They had a significantly higher likelihood in achieving adequate symptom relief at 12 weeks, with a clinically relevant number needed to treat (NNT) value of 2.36 (95% CI: 1.74, 3.64). Among secondary outcomes, statistically and clinically significant improvements were observed among global symptom (NNT = 3.85 [95% CI: 2.63, 7.69]); postprandial fullness and early satiation (NNT = 5.00 [95% CI: 2.86, 25.00]); as well as epigastric pain, epigastric burning, and postprandial nausea (NNT = 4.17 [95% CI: 2.56, 11.11]). Adverse events were minimal and nonsignificant.
CONCLUSION
For refractory FD, EA provides significant, clinically relevant symptom relief when added to on-demand gastrocaine (ChiCTR-IPC-15007109).",2019,"They had a significantly higher likelihood in achieving adequate symptom relief at 12 weeks, with a clinically relevant number needed to treat (NNT) value of 2.36 (95% CI: 1.74, 3.64).","['Helicobacter pylori negative FD patients of the postprandial distress syndrome subtype refractory to proton pump inhibitor, prokinetics, or H 2 antagonists', 'refractory functional dyspepsia', '132 participants randomly assigned to']","['Electroacupuncture', 'EA plus on-demand gastrocaine (n\xa0=\xa066) or on-demand gastrocaine alone', 'demand gastrocaine', 'electroacupuncture (EA', 'EA combined with on-demand gastrocaine', 'For refractory FD']","['Adverse events', 'epigastric pain, epigastric burning, and postprandial nausea', 'proportion of patients achieving adequate relief of symptoms', 'global symptom', 'adequate symptom relief', 'postprandial fullness and early satiation']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0061138', 'cui_str': 'Gastrocaine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain (finding)'}, {'cui': 'C0541938', 'cui_str': 'Epigastric burning'}, {'cui': 'C0746783', 'cui_str': 'Postprandial nausea'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}]",132.0,0.322748,"They had a significantly higher likelihood in achieving adequate symptom relief at 12 weeks, with a clinically relevant number needed to treat (NNT) value of 2.36 (95% CI: 1.74, 3.64).","[{'ForeName': 'Vincent Ch', 'Initials': 'VC', 'LastName': 'Chung', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Charlene Hl', 'Initials': 'CH', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Irene Xy', 'Initials': 'IX', 'LastName': 'Wu', 'Affiliation': 'Xiang-Ya School of Public Health, Central South University, Chang-Sha, Hu-Nan, China.'}, {'ForeName': 'Jessica Yl', 'Initials': 'JY', 'LastName': 'Ching', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'William Kw', 'Initials': 'WK', 'LastName': 'Cheung', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Benjamin Hk', 'Initials': 'BH', 'LastName': 'Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Kam Leung', 'Initials': 'KL', 'LastName': 'Chan', 'Affiliation': 'School of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Pui Kuan', 'Initials': 'PK', 'LastName': 'Cheong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Justin Cy', 'Initials': 'JC', 'LastName': 'Wu', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.14737']
1005,31844890,A randomized controlled phase III study of VB-111 combined with bevacizumab vs bevacizumab monotherapy in patients with recurrent glioblastoma (GLOBE).,"BACKGROUND
Ofranergene obadenovec (VB-111) is an anticancer viral therapy that demonstrated in a phase II study a survival benefit for patients with recurrent glioblastoma (rGBM) who were primed with VB-111 monotherapy that was continued after progression with concomitant bevacizumab.
METHODS
This pivotal phase III randomized, controlled trial compared the efficacy and safety of upfront combination of VB-111 and bevacizumab versus bevacizumab monotherapy. Patients were randomized 1:1 to receive VB-111 1013 viral particles every 8 weeks in combination with bevacizumab 10 mg/kg every 2 weeks (combination arm) or bevacizumab monotherapy (control arm). The primary endpoint was overall survival (OS), and secondary endpoints were objective response rate (ORR) by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS).
RESULTS
Enrolled were 256 patients at 57 sites. Median exposure to VB-111 was 4 months. The study did not meet its primary or secondary goals. Median OS was 6.8 versus 7.9 months in the combination versus control arm (hazard ratio, 1.20; 95% CI: 0.91-1.59; P = 0.19) and ORR was 27.3% versus 21.9% (P = 0.26). A higher rate of grades 3-5 adverse events was reported in the combination arm (67% vs 40%), mainly attributed to a higher rate of CNS and flu-like/fever events. Trends for improved survival with combination treatment were seen in the subgroup of patients with smaller tumors and in patients who had a posttreatment febrile reaction.
CONCLUSIONS
In this study, upfront concomitant administration of VB-111 and bevacizumab failed to improve outcomes in rGBM. Change of treatment regimen, with the lack of VB-111 monotherapy priming, may explain the differences from the favorable phase II results.
CLINICAL TRIALS REGISTRATION
NCT02511405.",2020,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"['patients with recurrent glioblastoma (rGBM', 'patients with recurrent glioblastoma (GLOBE', '256 patients were enrolled at 57 sites']","['bevacizumab', 'VB-111 and bevacizumab versus bevacizumab monotherapy', 'VB-111 1013 viral particles q8W in combination with bevacizumab 10mg/Kg q2W (combination arm) or bevacizumab monotherapy (control arm', 'VB-111 and bevacizumab', 'VB-111 combined with bevacizumab vs. bevacizumab monotherapy']","['survival', 'rate of CNS and flu-like/fever events', 'overall survival (OS', 'objective response rate (ORR) by RANO and Progression Free Survival (PFS', 'efficacy and safety', 'ORR', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",256.0,0.111146,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Department of Neurology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brenner', 'Affiliation': 'University of Texas Health San Antonio Cancer Center, San Antonio, Texas, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'de Groot', 'Affiliation': 'Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Butowski', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Leor', 'Initials': 'L', 'LastName': 'Zach', 'Affiliation': 'Oncology Institute, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Jian L', 'Initials': 'JL', 'LastName': 'Campian', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Freedman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Lowenton-Spier', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Rachmilewitz Minei', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Shifra', 'Initials': 'S', 'LastName': 'Fain Shmueli', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",Neuro-oncology,['10.1093/neuonc/noz232']
1006,31794857,Limited effect of a self-management exercise program added to spa therapy for increasing physical activity in patients with knee osteoarthritis: A quasi-randomized controlled trial.,"BACKGROUND
The efficacy of spa therapy in osteoarthritis (OA) has ever been demonstrated, with a good level of evidence for pain and disability. The effect of a self-management program with spa therapy on physical activity (PA) level has never been demonstrated.
OBJECTIVE
This study aimed to assess, at 3 months, the effectiveness of 5 sessions of a self-management exercise program in patients with knee OA (KOA) who benefit from 18 days of spa therapy and received an information booklet (on proposed physical exercises) on improvement in at least one PA level.
METHODS
This was an interventional, multicentre, quasi-randomized controlled trial with a cluster randomized design (1-month period). People 50 to 75 years old with symptomatic knee OA were included in 3 spa therapy centres in France (Bourbon Lancy, Le Mont Dore, Royat). Both groups received conventional spa therapy sessions during 18 days and an information booklet on the benefits of PA practice for KOA. The intervention group additionally received 5 self-management exercise sessions. The main outcome was improvement in at least one PA level according to the International Physical Activity Questionnaire (IPAQ) short-form categorical score (low to moderate or high, or moderate to high) at 3 months. Secondary outcomes were the evolution of PA (MET-min/week), disability, pain, anxiety, depression, self-efficacy, fears and beliefs concerning KOA, barriers to and facilitators of regular PA practice, consumption of painkillers and adherence to physical exercise program at 3 months. Assessors but not participants or caregivers were blinded.
RESULTS
In total, 123 patients were randomized, 54 to the intervention group and 69 to the control group. Considering the main outcome, at 3 months, 37% of patients in the intervention group showed improvement in at least one PA level according to the IPAQ categorical score versus 30.4% in the control group (P=0.44). In the intervention group, 13 (24.1%) patients showed improvement from low to moderate PA level (vs. 8 [11.6%] in the control group), 2 (3.7%) from low to high (vs. 2 [2.9%]) and 5 (9.3%) from moderate to highvs. 11 [15.9%]). Both intervention and control groups showed increased IPAQ continuous scores (MET-min/week) at 3 months, although not significantly. HAD anxiety and depression scores were significantly reduced in the intervention group (P=0.001 and P=0.049, respectively) and the perception of PA was better in the intervention than control group for motivation and barriers scores (P=0.019 and P=0.002, respectively).
CONCLUSIONS
This study showed the lack of impact of a short self-management program on PA level in addition to 18-day spa therapy for KOA, but both intervention and control groups showed improved PA level.",2020,"HAD anxiety and depression scores were significantly reduced in the intervention group (p=0.001 and p=0.049, respectively) and the perception of PA was better in the intervention than control group for motivation and barriers scores (p=0.019 and p=0.002, respectively).
","['patients with knee OA (KOA) who benefit from 18 days of spa therapy and received an', 'patients with knee osteoarthritis', 'People 50 to 75 years old with symptomatic knee OA (KOA', 'osteoarthritis (OA', '123 patients were randomized, 54 to the intervention group and 69 to the control group']","['self-management program with spa therapy', 'conventional spa therapy sessions', 'short self-management program', '5 self-management exercise sessions', 'self-management exercise program', 'information booklet (on proposed physical exercises', 'spa therapy']","['physical activity (PA) level', 'PA level', 'International Physical Activity Questionnaire (IPAQ) short-form categorical score', 'perception of PA', 'moderate PA level', 'IPAQ continuous scores', 'physical activity', 'motivation and barriers scores', 'evolution of PA (MET-min/week), disability, pain, anxiety, depression, self-efficacy, fears and beliefs concerning KOA, barriers to and facilitators of regular PA practice, consumption of painkillers and adherence to physical exercise program', 'IPAQ categorical score', 'HAD anxiety and depression scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",123.0,0.0528879,"HAD anxiety and depression scores were significantly reduced in the intervention group (p=0.001 and p=0.049, respectively) and the perception of PA was better in the intervention than control group for motivation and barriers scores (p=0.019 and p=0.002, respectively).
","[{'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Gay', 'Affiliation': ""Service d'épidémiologie et de santé publique, Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal, 63000 Clermont-Ferrand, France.""}, {'ForeName': 'Candy', 'Initials': 'C', 'LastName': 'Guiguet-Auclair', 'Affiliation': ""Service d'épidémiologie et de santé publique, Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal, 63000 Clermont-Ferrand, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Coste', 'Affiliation': 'Service de Médecine Physique et de Réadaptation, CHU de Clermont Ferrand, INRA, Université Clermont Auvergne, Clermont Ferrand, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Boisseau', 'Affiliation': ""Laboratoire des Adaptations Métaboliques à l'Exercice en condition Physiologiques et Pathologiques (AME2P), Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Gerbaud', 'Affiliation': ""Service d'épidémiologie et de santé publique, Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal, 63000 Clermont-Ferrand, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Délégation Recherche Clinique et Innovation, CHU de Clermont Ferrand, Université Clermont Auvergne, Clermont Ferrand, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coudeyre', 'Affiliation': 'Délégation Recherche Clinique et Innovation, CHU de Clermont Ferrand, Université Clermont Auvergne, Clermont Ferrand, France. Electronic address: ecoudeyre@chu-clermontferrand.fr.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.10.006']
1007,31316314,"Updated Survival Analysis after a Median Follow-up of 12 Years of an Anthracycline-Containing Adjuvant Prospective Multicentre, Randomised Phase III Trial on Dose-Dense Chemotherapy in Primary Node-Positive, High-Risk Breast Cancer Patients.","Purpose
Although dose-dense (dd) chemotherapy plays a fundamental role in the treatment of breast cancer (BC), a variety of trials have presented divergent survival results. Here, we present data of patients with more than 3 positive axillary lymph nodes (+aLN) receiving dd chemotherapy after a median follow-up period of 12.3 years.
Methods
In the years 1996-2000, 231 patients with invasive BC, ≥pN2a and no evidence of distant metastases were recruited to receive treatment A, i.e. dd 3 × epirubicin (E, 90 mg/m2) + paclitaxel (P, 175 mg/m2) every 2 weeks (q2w) followed by 3 × cyclophosphamide (C)/methotrexate/5-fluorouracil (CMF, 600/40/600 mg/m2, q2w), or treatment B, i.e. 4 × E + C (C, 600 mg/m2) q3w followed by 3 × CMF q3w.
Results
113 patients in arm A and 113 patients in arm B were analysed after an updated median follow-up of 12.3 years. The median age was 55 years, with a median number of 6 +aLN, 50.4% had a T2 and 79.2% hormone receptor-positive BC. The disease-free survival (DFS) rate was 53.1% in arm A and 42.5% in arm B (adjusted p = 0.027). The overall survival (OS) rate was 54.9% in arm A and 48.7% in arm B (adjusted p = 0.058). In the multivariable analysis, the tumour burden was a significant predictor for DFS and OS.
Conclusion
The adjuvant use of dd chemotherapy led to a statistically significant improvement of DFS after a follow-up of 12.3 years.",2019,The overall survival (OS) rate was 54.9% in arm A and 48.7% in arm B (adjusted p = 0.058).,"['The median age was 55 years, with a median number of 6 +aLN, 50.4% had a T2 and 79.2% hormone receptor-positive BC', 'Primary Node', 'High-Risk Breast Cancer Patients', 'In the years 1996-2000, 231 patients with invasive BC, ≥pN2a and no evidence of distant metastases', 'patients with more than 3 positive axillary lymph nodes (+aLN) receiving dd chemotherapy after a median follow-up period of 12.3 years']","['cyclophosphamide (C)/methotrexate/5-fluorouracil (CMF', 'dd chemotherapy', 'epirubicin', ' paclitaxel']","['overall survival (OS) rate', 'DFS', 'disease-free survival (DFS) rate']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node structure (body structure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",231.0,0.107195,The overall survival (OS) rate was 54.9% in arm A and 48.7% in arm B (adjusted p = 0.058).,"[{'ForeName': 'Mattea', 'Initials': 'M', 'LastName': 'Reinisch', 'Affiliation': 'Breast Unit, Evangelische Huyssens-Stiftung, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Gluz', 'Affiliation': 'Bethesda Hospital, Breast Center Niederrhein, Mönchengladbach, Germany; West German Study Group, Mönchengladbach, Germany.'}, {'ForeName': 'Beyhan', 'Initials': 'B', 'LastName': 'Ataseven', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Evangelische Huyssens-Stiftung, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Breast Center, Charité Hospital Berlin, Berlin, Germany.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Budner', 'Affiliation': 'Breast Unit, Helios Klinikum, Bad Saarow, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dittmer-Grabowski', 'Affiliation': 'Breast Unit, Evangelische Huyssens-Stiftung, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kohls', 'Affiliation': 'Breast Unit, Evangelisches Krankenhaus Ludwigsfelde-Teltow, Ludwigsfelde-Teltow, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Krocker', 'Affiliation': 'Breast Unit, Sana Klinikum Berlin-Lichtenberg, Berlin, Germany.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Kümmel', 'Affiliation': 'Breast Unit, Evangelische Huyssens-Stiftung, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Hagemann', 'Affiliation': 'Breast Unit, Evangelische Huyssens-Stiftung, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rüland', 'Affiliation': 'Breast Unit, Evangelische Huyssens-Stiftung, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Traut', 'Affiliation': 'Statistician, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Breast Unit, Evangelische Huyssens-Stiftung, Kliniken Essen Mitte, Essen, Germany.'}]","Breast care (Basel, Switzerland)",['10.1159/000491792']
1008,31880795,Single-Nucleotide Polymorphism-Based Genetic Risk Score and Patient Age at Prostate Cancer Diagnosis.,"Importance
Few studies have evaluated the association between a single-nucleotide polymorphism-based genetic risk score (GRS) and patient age at prostate cancer (PCa) diagnosis.
Objectives
To test the association between a GRS and patient age at PCa diagnosis and to compare the performance of a GRS with that of family history (FH) in PCa risk stratification.
Design, Setting, and Participants
A cohort study of 3225 white men was conducted as a secondary analysis of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) chemoprevention trial, a 4-year, randomized, double-blind, placebo-controlled multicenter study conducted from March 2003 to April 2009 to evaluate the safety and efficacy of dutasteride in reducing PCa events. Participants were confirmed to be cancer free by prostate biopsy (6-12 cores) within 6 months prior to the study and underwent 10 core biopsies every 2 years per protocol. The dates for performing data analysis were from July 2016 to October 2019.
Interventions
A well-established, population-standardized GRS was calculated for each participant based on 110 known PCa risk-associated single-nucleotide polymorphisms, which is a relative risk compared with the general population. Men were classified into 3 GRS risk groups based on predetermined cutoff values: low (<0.50), average (0.50-1.49), and high (≥1.50).
Main Outcomes and Measures
Prostate cancer diagnosis-free survival among men of different risk groups.
Results
Among 3225 men (median age, 63 years [interquartile range, 58-67 years]) in the study, 683 (21%) were classified as low risk, 1937 (60%) as average risk, and 605 (19%) as high risk based on GRS alone. In comparison, 2789 (86%) were classified as low or average risk and 436 (14%) as high risk based on FH alone. Men in higher GRS risk groups had a PCa diagnosis-free survival rate that was worse than that of those in the lower GRS risk group (χ2 = 53.3; P < .001 for trend) and in participants with a negative FH of PCa (χ2 = 45.5; P < .001 for trend). Combining GRS and FH further stratified overall genetic risk, indicating that 957 men (30%) were at high genetic risk (either high GRS or positive FH), 1667 men (52%) were at average genetic risk (average GRS and negative FH), and 601 men (19%) were at low genetic risk (low GRS and negative FH). The median PCa diagnosis-free survival was 74 years (95% CI, 73-75 years) for men at high genetic risk, 77 years (95% CI, 75 to >80 years) for men at average genetic risk, and more than 80 years (95% CI, >80 to >80 years) for men at low genetic risk. In contrast, the median PCa diagnosis-free survival was 73 years (95% CI, 71-76 years) for men with a positive FH and 77 years (95% CI, 76-79 years) for men with a negative FH.
Conclusions and Relevance
This study suggests that a GRS is significantly associated with patient age at PCa diagnosis. Combining FH and GRS may better stratify inherited risk than FH alone for developing personalized PCa screening strategies.",2019,Men in higher GRS risk groups had a PCa diagnosis-free survival rate that was worse than that of those in the lower GRS risk group (χ2 = 53.3; P < .001 for trend) and in participants with a negative FH of PCa (χ2 = 45.5; P < .001 for trend).,"['Men were classified into 3 GRS risk groups based on predetermined cutoff values: low (<0.50), average (0.50-1.49), and high (≥1.50', '3225 white men', '3225 men (median age, 63 years [interquartile range, 58-67 years]) in the study, 683 (21%) were classified as low risk, 1937 (60%) as average risk, and 605 (19%) as high risk based on GRS alone', 'Participants were confirmed to be cancer free by prostate biopsy (6-12 cores) within 6 months prior to the study and underwent 10 core biopsies every 2 years per protocol', '75 to >80 years) for men at average genetic risk, and more than 80 years (95% CI, >80 to >80 years) for men at low genetic risk', '957 men (30%) were at high genetic risk (either high GRS or positive FH), 1667 men (52%) were at average genetic risk (average GRS and negative FH), and 601 men (19%) were at low genetic risk (low GRS and negative FH']","['placebo', 'dutasteride']","['PCa events', 'PCa diagnosis-free survival rate', 'median PCa diagnosis-free survival', 'Measures\n\n\nProstate cancer diagnosis-free survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4708909', 'cui_str': '1667 (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",1667.0,0.0845362,Men in higher GRS risk groups had a PCa diagnosis-free survival rate that was worse than that of those in the lower GRS risk group (χ2 = 53.3; P < .001 for trend) and in participants with a negative FH of PCa (χ2 = 45.5; P < .001 for trend).,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Na', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Labbate', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Zhuqing', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Fantus', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Chi-Hsiung', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': 'Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Isaacs', 'Affiliation': 'James Buchanan Brady Urological Institute, Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'S Lilly', 'Initials': 'SL', 'LastName': 'Zheng', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Helfand', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18145']
1009,31892352,The ED 50 and ED 95 of oxytocin infusion rate for maintaining uterine tone during elective caesarean delivery: a dose-finding study.,"BACKGROUND
The 90% effective dose (ED 90 ) of oxytocin infusion has been previously estimated to be 16.2 IU h - 1 . However, bolus administration of oxytocin prior to the infusion may decrease the infusion dose required. The aim of this study was to estimate the ED 95 for oxytocin infusion after a bolus at elective caesarean delivery (CD) in nonlaboring parturients.
METHODS
We performed a randomized, triple blinded study in 150 healthy termparturients scheduled for elective CD under epidural anaesthesia. After delivery of the infant and i.v. administration of 1 IU oxytocin as a bolus, Participants were randomized to receive oxytocin infusion at a rate of 0, 1, 2, 3, 5, or 8 IU h - 1 , to be given for a total of 1 h. Uterine tone assessed by the blinded obstetrician as either adequate or inadequate. Secondary outcomes included estimated blood loss (EBL), requirement for supplemental uterotonic agents, and development of side effects.
RESULTS
The 95% effective dose (ED 95 ) of oxytocin infusion was estimated to be 7.72 IU h - 1 (95% confidence interval 5.80-12.67 IU h - 1 ). With increasing oxytocin infusion rate, the proportion of parturients who needed rescue oxytocin bolus or secondary uterotonic agents decreased. No significant among-group differences in the EBL and oxytocin-related side effects were observed.
CONCLUSIONS
In parturients who receive a 1 IU bolus of oxytocin during elective cesarean delivery, an infusion rate of oxytocin at 7.72 IU h - 1 will produce adequate uterine tone in 95% of parturients. These results suggest that the total dose of oxytocin administered in the postpartum period can be decreased when administered as an infusion after oxytocin bolus.",2019,"No significant among-group differences in the EBL and oxytocin-related side effects were observed.
","['nonlaboring parturients', '150 healthy termparturients scheduled for elective CD under epidural anaesthesia']","['oxytocin', '1\u2009IU oxytocin']","['Uterine tone', 'estimated blood loss (EBL), requirement for supplemental uterotonic agents, and development of side effects', 'EBL and oxytocin-related side effects']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C3653843', 'cui_str': 'Other uterotonics in ATC'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",150.0,0.553315,"No significant among-group differences in the EBL and oxytocin-related side effects were observed.
","[{'ForeName': 'Xiao Wei', 'Initials': 'XW', 'LastName': 'Qian', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, China.""}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Drzymalski', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Chang Cheng', 'Initials': 'CC', 'LastName': 'Lv', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, China.""}, {'ForeName': 'Fei He', 'Initials': 'FH', 'LastName': 'Guo', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, China.""}, {'ForeName': 'Lu Yang', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, China.""}, {'ForeName': 'Xin Zhong', 'Initials': 'XZ', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, China. chenxinz@zju.edu.cn.""}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2692-x']
1010,31786218,Nitinol Stent Versus Bypass in Long Femoropopliteal Lesions: 2-Year Results of a Randomized Controlled Trial.,"OBJECTIVES
This study sought to compare patency rates and clinical outcomes of nitinol stents and primary vein bypass in long femoropopliteal lesions.
BACKGROUND
An endovascular-first strategy for long femoropopliteal lesions is widely recommended without sufficient data comparing it with bypass surgery. Nitinol stents are widely used as the standard endovascular therapy.
METHODS
A single-center randomized controlled trial was performed with the primary endpoints of technical success, primary and secondary patency. Secondary endpoints were limb salvage, survival, complications, and clinical improvement.
RESULTS
A total of 110 limbs (55 per group) in 103 patients were treated. Baseline and lesion characteristics were similar, with a mean lesion length of 276 mm. Critical limb threatening ischemia was the indication for treatment in 49% of limbs in both groups. Technical success was achieved in 87% in the stent group. During a 2-year follow-up, patency rates, limb salvage, survival and complications showed no significant differences between both groups. At 24 months, primary and secondary patency rates for the stent group were 60% and 72% versus 56% and 73% in the bypass group, respectively. Clinical improvement was significantly better in the bypass group.
CONCLUSIONS
There were no significant differences regarding patency rates, limb salvage, survival, or complications after 2 years. Technical success and clinical improvement in the bypass group were significantly better, but the promising results of the stent group suggest that an endovascular-first strategy for femoropopliteal lesions up to 30 cm may be reasonable. Mid- as well as long-term results need to be awaited.",2019,"During a 2-year follow-up, patency rates, limb salvage, survival and complications showed no significant differences between both groups.","['A total of 110 limbs (55 per group) in 103 patients were treated', 'Long Femoropopliteal Lesions']","['Nitinol stents', 'Nitinol Stent Versus Bypass', 'nitinol stents and primary vein bypass']","['patency rates and clinical outcomes', 'technical success, primary and secondary patency', 'Technical success', 'secondary patency rates', 'limb salvage, survival, complications, and clinical improvement', 'patency rates, limb salvage, survival and complications', 'Technical success and clinical improvement', 'patency rates, limb salvage, survival, or complications']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0949591', 'cui_str': 'Limb Salvage'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",103.0,0.129423,"During a 2-year follow-up, patency rates, limb salvage, survival and complications showed no significant differences between both groups.","[{'ForeName': 'Florian K', 'Initials': 'FK', 'LastName': 'Enzmann', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria. Electronic address: f.enzmann@salk.at.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nierlich', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Aspalter', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hitzl', 'Affiliation': 'Research Office (Biostatistics), Paracelsus Medical University, Salzburg, Austria; Department of Ophthalmology and Optometry, Paracelsus Medical University, Salzburg, Austria; Research Program Experimental Ophthalmology and Glaucoma Research, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Dabernig', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hölzenbein', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Ugurluoglu', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Rainald', 'Initials': 'R', 'LastName': 'Seitelberger', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Linni', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.006']
1011,31870438,"AMAFRICA, a patient-navigator program for accompanying lymphoma patients during chemotherapy in Ivory Coast: a prospective randomized study.","BACKGROUND
Previous studies have indicated that accompanying socially underserved cancer patients through Patient Navigator (PN) or PN-derived procedures improves therapy management and reassurance. At the Cancer Institute of Toulouse-Oncopole (France), we have implemented AMA (Ambulatory Medical Assistance), a PN-based procedure adapted for malignant lymphoma (ML) patients under therapy. We found that AMA improves adherence to chemotherapy and safety. In low-middle income countries (LMIC), refusal and abandonment were documented as major adverse factors for cancer therapy. We reasoned that AMA could improve clinical management of ML patients in LMIC.
METHODS
This study was set up in the Abidjan University Medical Center (Ivory Coast) in collaboration with Toulouse. One hundred African patients were randomly assigned to either an AMA or control group. Main criteria of judgment were refusal and abandonment of CHOP or ABVD chemotherapy.
RESULTS
We found that AMA was feasible and had significant impact on refusal and abandonment. However, only one third of patients completed their therapy in both groups. No differences were noted in terms of complete response rate (CR) (16% based on intent-to-treat) and median overall survival (OS) (6 months). The main reason for refusal and abandonment was limitation of financial resources.
CONCLUSION
Altogether, this study showed that PN may reduce refusal and abandonment of treatment. However, due to insufficient health care coverage, its ultimate impact on OS remains limited.",2019,No differences were noted in terms of complete response rate (CR) (16% based on intent-to-treat) and median overall survival (OS) (6 months).,"['Abidjan University Medical Center (Ivory Coast) in collaboration with Toulouse', 'One hundred African patients', 'accompanying lymphoma patients during chemotherapy in Ivory Coast']","['AMA', 'AMA or control group']","['adherence to chemotherapy and safety', 'complete response rate (CR', 'refusal and abandonment', 'median overall survival (OS']","[{'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0022326', 'cui_str': 'Republic of Cote diIvoire'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",100.0,0.0640043,No differences were noted in terms of complete response rate (CR) (16% based on intent-to-treat) and median overall survival (OS) (6 months).,"[{'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Koffi', 'Affiliation': ""Hematology Teaching Hospital of Yopougon University Medical Center, Abidjan, Côte d'Ivoire. guskof1@yahoo.fr.""}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Silué', 'Affiliation': ""Hematology Teaching Hospital of Yopougon University Medical Center, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Laurent', 'Affiliation': 'Hematology Department of Toulouse University Medical Center, Toulouse, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Boidy', 'Affiliation': ""Hematology Teaching Hospital of Yopougon University Medical Center, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koui', 'Affiliation': ""Hematology Teaching Hospital of Yopougon University Medical Center, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Compaci', 'Affiliation': 'Hematology Department of Toulouse University Medical Center, Toulouse, France.'}, {'ForeName': 'Z H', 'Initials': 'ZH', 'LastName': 'Adeba', 'Affiliation': ""Hematology Teaching Hospital of Yopougon University Medical Center, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kamara', 'Affiliation': ""Hematology Teaching Hospital of Yopougon University Medical Center, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Botty', 'Affiliation': ""Hematology Teaching Hospital of Yopougon University Medical Center, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Bognini', 'Affiliation': ""Hematology Teaching Hospital of Yopougon University Medical Center, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sanogo', 'Affiliation': ""Hematology Teaching Hospital of Yopougon University Medical Center, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Despas', 'Affiliation': 'Hematology Department of Toulouse University Medical Center, Toulouse, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Laurent', 'Affiliation': 'Hematology Department of Toulouse University Medical Center, Toulouse, France.'}]",BMC cancer,['10.1186/s12885-019-6478-3']
1012,31669455,Is Ultrasonic Bone Scalpel Useful in Le Fort I Osteotomy?,"PURPOSE
Safety and precision are 2 main goals in research to improve bone cutting in maxillofacial surgery. The aim of this prospective clinical study was to analyze the outcomes using an ultrasonic bone scalpel versus a piezoelectric surgical device and the conventional technique in a Le Fort I osteotomy.
MATERIALS AND METHODS
We designed a prospective, randomized, single-blind cohort study. The predictor variables were the devices used to perform the Le Fort I osteotomy, divided into 3 groups: 1) ultrasonic bone scalpel (BoneScalpel; Misonix, Farmingdale, NY), 2) piezoelectric surgical device, and 3) conventional technique (Lindeman burr and reciprocal saw). The primary outcome of the study was cutting time, whereas secondary outcomes were length of the procedure, total blood loss, intraoperative complications, and postoperative edema. Other variables of interest were age and gender. Data were analyzed using 1-way analysis of variance and the Kruskal-Wallis test.
RESULTS
The study sample was composed of 34 patients with a mean age of 21.5 years, and 63.3% of patients were women. The mean cutting time (P < .001) and length of the procedure (P = .012) were significantly shorter with the bone scalpel than with the other types of surgery. The ultrasonic bone scalpel showed a significant reduction in intraoperative blood loss of up to 45% compared with the piezoelectric surgical device and the conventional technique (P = .038).
CONCLUSIONS
The results of this study suggest that the ultrasonic bone scalpel is an effective ultrasonic bone-cutting instrument in a Le Fort I osteotomy as evidenced by the significant decrease in the cutting time, intraoperative blood loss, and postoperative edema compared with the other techniques.",2020,The mean cutting time (P < .001) and length of the procedure (P = .012) were significantly shorter with the bone scalpel than with the other types of surgery.,"['34 patients with a mean age of 21.5\xa0years, and 63.3% of patients were women']","['ultrasonic bone scalpel (BoneScalpel; Misonix, Farmingdale, NY), 2) piezoelectric surgical device, and 3) conventional technique (Lindeman burr and reciprocal saw', 'ultrasonic bone scalpel', 'ultrasonic bone scalpel versus a piezoelectric surgical device and the conventional technique']","['mean cutting time', 'length of the procedure, total blood loss, intraoperative complications, and postoperative edema', 'cutting time, intraoperative blood loss, and postoperative edema', 'intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0330093', 'cui_str': 'Burr (substance)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.037364,The mean cutting time (P < .001) and length of the procedure (P = .012) were significantly shorter with the bone scalpel than with the other types of surgery.,"[{'ForeName': 'Ahmet Emin', 'Initials': 'AE', 'LastName': 'Demirbas', 'Affiliation': 'Assistant Professor and Department Head, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University, Melikgazi, Turkey. Electronic address: aedemirbas@erciyes.edu.tr.'}, {'ForeName': 'Suheyb', 'Initials': 'S', 'LastName': 'Bilge', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University, Melikgazi, Turkey.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Celebi', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University, Melikgazi, Turkey.'}, {'ForeName': 'Nükhet', 'Initials': 'N', 'LastName': 'Kütük', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Alkan', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Bezmialem Vakif University, Istanbul, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.021']
1013,31283053,The influence of oxytocin on risk-taking in the balloon analogue risk task among women with bulimia nervosa and binge eating disorder.,"Previous theoretical models of bulimia nervosa (BN) and binge eating disorder (BED) have implicated cross-domain risk-taking behaviour as a significant maintenance factor in both disorders. The present study aimed to test this hypothesis by administering the Balloon Analogue Risk Task (BART) to 25 women with BN or BED and 27 healthy comparison women without a history of an eating disorder. Furthermore, we tested the effect of a divided dose of 64 IU of oxytocin on risk-taking behaviour in the BART. Contrary to our hypothesis, women with BN or BED did not exhibit baseline differences in performance on the BART in the placebo condition (t = 1.42, df = 50, P = 0.161, d = 0.39). Oxytocin did not have a main effect on performance in the BART (F = 0.01, df = 1, P = .907, η 2 partial < 0.001); however, there was an interaction, such that participants in the BN/BED participant group, compared to the healthy comparison group, demonstrated safer behaviour on the BART in the oxytocin condition, but not in the placebo condition (F = 4.29, df = 1, P = 0.044, η 2 partial = 0.082). These findings cast doubt on the common assumption that individuals with BN and BED exhibit greater risk-taking behaviour in all domains and add to the evidence that oxytocin plays a functional role in modulating behaviours that entail trade-offs between reward approach and risk in humans. We recommend that future dose-response studies investigate the effect of oxytocin on reward approach behaviour further in women with recurrent binge eating behaviour, as well as the clinical significance of this effect.",2019,"Oxytocin did not have a main effect on performance in the BART (F = 0.01, df = 1, p = .907, η 2 partial < .001); however, there was an interaction such that participants in the BN/BED participant group, compared to the healthy comparison group, demonstrated safer behaviour on the BART specifically in the oxytocin condition, but not in the placebo condition (F = 4.29, df = 1, p = .044, η 2 partial = .082).","['Women with Bulimia Nervosa and Binge Eating Disorder', '25 women with BN or BED and 27 healthy comparison women without history of an eating disorder', 'women with recurrent binge eating behaviour', 'bulimia nervosa (BN) and binge eating disorder (BED']","['64IU oxytocin', 'oxytocin', 'Oxytocin', 'Balloon Analogue Risk Task (BART']","['Risk-Taking in the Balloon Analogue Risk Task', 'risk-taking behaviour', 'safer behaviour']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",25.0,0.122906,"Oxytocin did not have a main effect on performance in the BART (F = 0.01, df = 1, p = .907, η 2 partial < .001); however, there was an interaction such that participants in the BN/BED participant group, compared to the healthy comparison group, demonstrated safer behaviour on the BART specifically in the oxytocin condition, but not in the placebo condition (F = 4.29, df = 1, p = .044, η 2 partial = .082).","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Leslie', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Leppanen', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}, {'ForeName': 'Bruno Palazzo', 'Initials': 'BP', 'LastName': 'Nazar', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""King's College London (KCL), Institute of Psychiatry, Psychology and Neuroscience (IoPPN), London, UK.""}]",Journal of neuroendocrinology,['10.1111/jne.12771']
1014,31337877,Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study.,"BACKGROUND
Retrospective studies suggest that low molecular weight heparin may delay the development of metastasis in patients with resected NSCLC.
METHODS
Multicentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive chemotherapy with or without nadroparin. The main exclusion criteria were R1/2 and wedge/segmental resection. FDG-PET was required. The primary endpoint was recurrence-free survival (RFS).
RESULTS
Among 235 registered patients, 202 were randomised (nadroparin: n = 100; control n = 102). Slow accrual enabled a decrease in the number of patients needed from 600 to 202, providing 80% power to compare RFS with 94 events (α = 0.05; 2-sided). There were no differences in bleeding events between the two groups. The median RFS was 65.2 months (95% CI, 36-NA) in the nadroparin arm and 37.7 months (95% CI, 22.7-NA) in the control arm (HR 0.77 (95% CI, 0.53-1.13, P = 0.19). FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22-0.9, P = 0.05).
CONCLUSIONS
Adjuvant nadroparin did not improve RFS in patients with resected NSCLC. In this study, a high SUVmax predicted a greater likelihood of recurrence in the first year.
CLINICAL TRIAL REGISTRATION
Netherlands Trial registry: NTR1250/1217.",2019,"FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22-0.9, P = 0.05).
","['patients with completely resected non-small-cell lung cancer', '235 registered patients, 202 were randomised (nadroparin: n\u2009=\u2009100; control n\u2009=\u2009102', 'patients with resected NSCLC', 'patients with resected NSCLC.\nMETHODS\n\n\nMulticentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive']","['adjuvant chemotherapy with or without nadroparin', 'chemotherapy with or without nadroparin']","['median RFS', 'RFS', 'recurrence-free survival (RFS', 'bleeding events', 'likelihood of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0206232', 'cui_str': 'Nadroparin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0206232', 'cui_str': 'Nadroparin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",202.0,0.512985,"FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22-0.9, P = 0.05).
","[{'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'Department of Pulmonary Disease, University of Groningen and University Medical Center Groningen, Hanzeplein 1, Box 30.001, 9700 RB, Groningen, Netherlands. h.j.m.groen@umcg.nl.'}, {'ForeName': 'Erik H F M', 'Initials': 'EHFM', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Pulmonary Diseases, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Netherlands.'}, {'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Klinkenberg', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Groningen and University Medical Center Groningen, Hanzeplein 1, Box 30.001, 9700 RB, Groningen, Netherlands.'}, {'ForeName': 'Bonne', 'Initials': 'B', 'LastName': 'Biesma', 'Affiliation': ""Department of Pulmonary Diseases, Jeroen Bosch Hospital, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Aerts', 'Affiliation': 'Department of Pulmonary Diseases, Erasmus Medical Center, Dr Molewaterplein 40, 3015 GD, Rotterdam, Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Verhagen', 'Affiliation': 'Department of Cardiothoracic Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Netherlands.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Kloosterziel', 'Affiliation': 'Department of Pulmonary Diseases, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, Netherlands.'}, {'ForeName': 'Remge', 'Initials': 'R', 'LastName': 'Pieterman', 'Affiliation': 'Department of Pulmonary Diseases, Ommelander Hospital Group, Pastorieweg 1, 9679 BJ, Scheemda, Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'van den Borne', 'Affiliation': 'Department of Pulmonary Diseases, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, Netherlands.'}, {'ForeName': 'Hans J M', 'Initials': 'HJM', 'LastName': 'Smit', 'Affiliation': 'Department of Pulmonary Diseases, Rijnstate Hospital, Wagnerlaan 55, 6815 AD, Arnhem, Netherlands.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Nuclear Medicine, Amsterdam University Medical Center, De Boelelaan 1117, 1081, HVAmsterdam, Netherlands.'}, {'ForeName': 'Frans M N H', 'Initials': 'FMNH', 'LastName': 'Schramel', 'Affiliation': 'Department of Pulmonary Diseases, St Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'van der Noort', 'Affiliation': 'Department of Biometrics, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'Department of Biometrics, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, Netherlands.'}, {'ForeName': 'Egbert F', 'Initials': 'EF', 'LastName': 'Smit', 'Affiliation': 'Department of Thoracic Oncology, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, Netherlands.'}, {'ForeName': 'Anne-Marie C', 'Initials': 'AC', 'LastName': 'Dingemans', 'Affiliation': 'Department of Pulmonary Diseases, Maastricht University Medical Center, P. Debijelaan 25, 6229 HX, Maastricht, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-019-0533-3']
1015,31337448,"Protein supplementation combined with low-intensity resistance training in geriatric medical patients during and after hospitalisation: a randomised, double-blind, multicentre trial.","Sarcopenia (loss of muscle mass/strength) burdens many older adults - hospitalised older adults being particularly vulnerable. Treating the condition, protein supplementation (PrS) and resistance training (RT) may act synergistically. Therefore, this block-randomised, double-blind, multicentre intervention study, recruiting geriatric patients > 70 years from three medical departments, investigated the effect of PrS combined with RT during hospitalisation and 12 weeks after discharge. Participants were randomly allocated (1:1) to receive PrS (totally 27·5 g whey protein/d, about 2000 kJ/d) or isoenergetic placebo-products (< 1·5 g protein/d) divided into two servings per d to supplement the habitual diet. Both groups were engaged in a standardised, progressive low-intensity RT programme for the lower extremities (hospital: supervised daily/after discharge: self-training 4×/week). From April 2016 to September 2017, 2351 patients were screened, 462 were eligible, and 165 included. Fourteen were excluded and ten dropped out, leaving 141 participants in the intention-to-treat analysis. The average total protein intake during hospitalisation/after discharge was 1·0 (interquartile range (IQR) 0·8, 1·3)/1·1 (IQR 0·9, 1·3) g/kg per d (protein-group) and 0·6 (IQR 0·5, 0·8)/0·9 (IQR 0·6, 1·0) g/kg per d (placebo group). Both groups improved significantly for the primary and secondary endpoints of muscle mass/strength, functional measurements and quality of life, but no additional effect of PrS was seen for the primary endpoint (30-s chair stand test, repetitions, median changes from baseline: (standard test: 0 (IQR 0, 5) (protein group) v. 2 (IQR 0, 6) (placebo group) and modified test: 2 (IQR 0, 5) (protein group) v. 2 (IQR -1, 5) (placebo group)) or any secondary endpoints (Mann-Whitney U tests, P > 0·05). In conclusion, PrS increasing the total protein intake by 0·4 and 0·2 g/kg per d during hospitalisation and after discharge, respectively, does not seem to increase the adaptive response to low-intensity RT in geriatric medical patients.",2019,"In conclusion, PrS increasing total protein intake by 0.4 and 0.2 g/kg/d during hospitalization and after discharge, respectively, does not seem to increase the adaptive response to low intensity/volume RT in geriatric medical patients.","['geriatric medical patients during and after hospitalization', 'older adults - hospitalized older adults', 'geriatric patients >70 years from three Medical Departments', 'geriatric medical patients']","['protein-supplementation (PrS) and resistance-training (RT', 'PrS combined with RT', 'Protein supplementation combined with low-intensity resistance training', 'PrS (totally 27.5 g whey protein/day, ≈2000 kJ/day) or iso-energetic placebo']",['total protein intake'],"[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0587450', 'cui_str': 'Medical department (environment)'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0456646', 'cui_str': 'kilojoules/day'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0555903', 'cui_str': 'Total protein measurement'}]",,0.287345,"In conclusion, PrS increasing total protein intake by 0.4 and 0.2 g/kg/d during hospitalization and after discharge, respectively, does not seem to increase the adaptive response to low intensity/volume RT in geriatric medical patients.","[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Gade', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen University, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Beck', 'Affiliation': 'Dietetics and Clinical Nutrition Research Unit, Herlev and Gentofte Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Hanne E', 'Initials': 'HE', 'LastName': 'Andersen', 'Affiliation': 'Medical Department M, Rigshospitalet-Glostrup, 2600 Glostrup, Denmark.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Arla Foods Amba, 8260 Viby, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Rønholt', 'Affiliation': 'Medical Department, Herlev and Gentofte Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Tobias W', 'Initials': 'TW', 'LastName': 'Klausen', 'Affiliation': 'Department of Haematology, Herlev and Gentofte Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Vinther', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy and QD-Research Unit, Herlev and Gentofte Hospital, 2730 Herlev, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen University, 2200 Copenhagen, Denmark.'}]",The British journal of nutrition,['10.1017/S0007114519001831']
1016,31066303,Comparing cervical mucus changes in response to an oral progestin or oestrogen withdrawal in ovarian-suppressed women: a clinical pilot.,"Purpose: Prior studies evaluating the effect of administered progestogens on peak cervical mucus have not controlled for the influence of endogenous hormones. To address this, we treated women with a gonadotropin-releasing hormone (GnRH) agonist to suppress the hypothalamus-pituitary-ovarian (HPO) axis and used transdermal oestradiol replacement to stimulate peak cervical mucus and then evaluated the effects of an oral progestin or oestradiol withdrawal. Materials and methods: We used a crossover design to examine cervical mucus changes in women receiving transdermal oestradiol replacement following intramuscular administration of leuprolide acetate. After increasing oestradiol patches to mid-cycle levels, subjects were assigned to either 0.35 mg oral norethindrone with continuation of the patches (NET) or oestradiol withdrawal by patch removal (E2WD). We collected serum and cervical mucus samples at 0, 2, 4, 6, 22 and 24 h following the intervention. Results: We analysed 12 cycles (6 NET, 6 E2WD) from three subjects. Baseline cervical mucus scores were favourable to sperm penetration [NET median 11, interquartile range (9-12), E2WD 13 (12-13)]. Two hours after removal of oestradiol patch or administration of norethindrone, cervical mucus scores declined [NET 8.5 (4-9), E2WD 10.5 (10-12)]. Low cervical mucus scores persisted at 24 h with NET [8.0 (7-8)] but not E2WD [10.5 (8-11)]. Conclusions: We observed a rapid decline in cervical mucus Insler scores following administration of a single dose of oral norethindrone, and scores remained lower and unfavourable through 24 h. Oestradiol withdrawal did not result in similar unfavourable changes.",2019,Low cervical mucus scores persisted at 24 h with NET [8.0 (7-8)] but not E2WD [10.5 (8-11)]. ,"['women receiving transdermal oestradiol replacement following intramuscular administration of', 'ovarian-suppressed women', 'treated women with a']","['oral norethindrone', 'oral progestin', 'norethindrone with continuation of the patches (NET) or oestradiol withdrawal by patch removal (E2WD', 'gonadotropin-releasing hormone (GnRH) agonist to suppress the hypothalamus-pituitary-ovarian (HPO) axis and used transdermal oestradiol replacement', 'leuprolide acetate', 'progestogens', 'norethindrone']","['Low cervical mucus scores', 'Baseline cervical mucus scores', 'cervical mucus scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement (procedure)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0028356', 'cui_str': 'norethisterone'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement (procedure)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0020663', 'cui_str': 'Preoptico-Hypothalamic Area'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0700596', 'cui_str': 'Leuprolide Acetate'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0007872', 'cui_str': 'Cervical Mucus'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.11359,Low cervical mucus scores persisted at 24 h with NET [8.0 (7-8)] but not E2WD [10.5 (8-11)]. ,"[{'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'a Department of Obstetrics and Gynecology , Oregon Health and Science University , Portland , OR , USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Padua', 'Affiliation': 'a Department of Obstetrics and Gynecology , Oregon Health and Science University , Portland , OR , USA.'}, {'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Hart', 'Affiliation': 'a Department of Obstetrics and Gynecology , Oregon Health and Science University , Portland , OR , USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Edelman', 'Affiliation': 'a Department of Obstetrics and Gynecology , Oregon Health and Science University , Portland , OR , USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'a Department of Obstetrics and Gynecology , Oregon Health and Science University , Portland , OR , USA.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2019.1605503']
1017,31854054,Individualized nutritional treatment for acute stroke patients with malnutrition risk improves functional independence measurement: A randomized controlled trial.,"AIM
The aim of the present study was to investigate the effects of individualized nutritional treatment on the activities of daily living of acute stroke patients.
METHODS
This was a randomized controlled study. The eligibility criteria were acute stroke, age >65 years and the presence of malnutrition risk. Between September 2016 and December 2017, 128 patients were assigned to either the standard or intensive group (individualized nutritional treatment). The intensive group received energy that was calculated using the Harris-Benedict equation. The main outcome measures were the total functional independence measurement gain from the time of assignment to the time of discharge from the recovery hospital or at 3 months after the stroke onset, and motor and cognitive functional independence measurement gains.
RESULTS
Compared with the standard group, the intensive group had significantly higher median energy intake (P < 0.001); significantly greater functional independence measurement gains in the total score (42 vs. 22; P = 0.02) and motor subscore (P = 0.01), but similar cognitive subscore.
CONCLUSION
Individualized nutritional treatment improved the activities of daily living of older acute stroke patients with malnutrition risk. Geriatr Gerontol Int 2019; ••: ••-••.",2020,"Compared with the standard group, the intensive group had significantly higher median energy intake (P < 0.001); significantly greater functional independence measurement gains in the total score (42 vs. 22; P = 0.02) and motor subscore (P = 0.01), but similar cognitive subscore.
","['The eligibility criteria were acute stroke, age >65\u2009years and the presence of malnutrition risk', 'acute stroke patients with malnutrition risk', 'older acute stroke patients with malnutrition risk', 'Between September 2016 and December 2017, 128 patients', 'acute stroke patients']","['individualized nutritional treatment', 'Individualized nutritional treatment', 'standard or intensive group (individualized nutritional treatment']","['median energy intake', 'total functional independence measurement gain from the time of assignment to the time of discharge from the recovery hospital or at 3\u2009months after the stroke onset, and motor and cognitive functional independence measurement gains', 'motor subscore', 'activities of daily living', 'functional independence measurement gains', 'functional independence measurement']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",128.0,0.0832643,"Compared with the standard group, the intensive group had significantly higher median energy intake (P < 0.001); significantly greater functional independence measurement gains in the total score (42 vs. 22; P = 0.02) and motor subscore (P = 0.01), but similar cognitive subscore.
","[{'ForeName': 'Ikuto', 'Initials': 'I', 'LastName': 'Otsuki', 'Affiliation': 'Department of Anesthesia, Otaru General Hospital, Otaru, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Himuro', 'Affiliation': 'Department of Public Health, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Hiroomi', 'Initials': 'H', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Intensive Care Medicine, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Health Science, Hokkaido Chitose College of Rehabilitation, Chitose, Japan.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Niiya', 'Affiliation': 'Department of Neurosurgery, Otaru General Hospital, Otaru, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Kumeta', 'Affiliation': 'Department of Anesthesia, Otaru General Hospital, Otaru, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}]",Geriatrics & gerontology international,['10.1111/ggi.13854']
1018,31339100,Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT.,"BACKGROUND
People with Parkinson's disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life.
OBJECTIVE
To estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson's disease.
DESIGN
A multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses.
SETTING
Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions.
PARTICIPANTS
A total of 474 people with Parkinson's disease (i.e. Hoehn and Yahr scale stages 1-4) were recruited: 238 were assigned to a physiotherapy programme and 236 were assigned to usual care. Random allocation was 50 : 50.
INTERVENTIONS
All participants received routine care; the usual-care group received an information digital versatile disc (DVD) and a single advice session at trial completion. The intervention group had an individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE.
MAIN OUTCOME MEASURES
The primary outcome was the risk of repeat falling, collected by self-report monthly diaries between 0 and 6 months after randomisation. Secondary outcomes included near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson's Disease Questionnaire.
RESULTS
PDSAFE is the largest RCT of falls management among people with Parkinson's disease: 541 patients were screened for eligibility. The average age was 72 years, and 266 out of 474 (56%) participants were men. Of the 474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group. No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR) 1.21, 95% confidence interval (CI) 0.74 to 1.98; p = 0.447]. An analysis of secondary outcomes demonstrated better balance (Mini-BESTest: mean difference 0.95, 95% CI 0.24 to 1.67; p = 0.009), functional strength (CST: p = 0.041) and falls efficacy (Falls Efficacy Scale - International: mean difference 1.6, 95% CI -3.0 to -0.19; p = 0.026) with near-falling significantly reduced with PDSAFE (OR 0.67, 95% CI 0.53 to 0.86; p = 0.001) at 6 months. Prespecified subgroup analysis (i.e. disease severity and FoG) revealed a PDSAFE differing effect; the intervention may be of benefit for people with moderate disease but may increase falling for those in the more severe category, especially those with FoG.
LIMITATIONS
All participants were assessed at primary outcome; only 73% were assessed at 12 months owing to restricted funding.
CONCLUSIONS
PDSAFE was not effective in reducing repeat falling across the range of people with Parkinson's disease in the trial. Secondary analysis demonstrated that other functional tasks and self-efficacy improved and demonstrated differential patterns of intervention impact in accordance with disease severity and FoG, which supports previous secondary research findings and merits further primary evaluation.
FUTURE WORK
Further trials of falls prevention on targeted groups of people with Parkinson's disease are recommended.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN48152791.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 36. See the NIHR Journals Library website for further project information. Sarah E Lamb is funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust, the NIHR Oxford Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust and CLAHRC Oxford. Victoria A Goodwin is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care in the South West Peninsula (PenCLAHRC). Lynn Rochester is supported by the NIHR Newcastle Biomedical Research Centre based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The research was also supported by the NIHR Newcastle Clinical Research Facility Infrastructure funding. Helen C Roberts is supported by CLAHRC Wessex and the NIHR Southampton Biomedical Research Centre.",2019,No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR),"['Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions', ""people with Parkinson's disease"", ""people with Parkinson's"", ""people with Parkinson's disease: 541 patients were screened for eligibility"", ""People with Parkinson's disease"", '474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group', ""A total of 474 people with Parkinson's disease (i.e. Hoehn and Yahr scale stages 1-4) were recruited: 238 were assigned to a"", 'The average age was 72 years, and 266 out of 474 (56%) participants were men']","['Exercise- and strategy-based physiotherapy-delivered intervention', 'physiotherapy programme', 'routine care; the usual-care group received an information digital versatile disc (DVD', 'individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE', 'PDSAFE']","[""near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson's Disease Questionnaire"", 'functional strength', 'functional tasks and self-efficacy', 'risk of repeat falling, collected by self-report monthly diaries', 'falls efficacy', 'repeat falling']","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0303719', 'cui_str': 'Americium-238 (substance)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4274667', 'cui_str': 'Hoehn and Yahr Scale (assessment scale)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}]","[{'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",541.0,0.144848,No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR),"[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ashburn', 'Affiliation': 'Faculty of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pickering', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Hulbert', 'Affiliation': 'Faculty of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Roberts', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'Department of Rehabilitation Sciences, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Kunkel', 'Affiliation': 'Faculty of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Goodwin', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Oxford Clinical Trials Research Unit, University of Oxford Medical Sciences Division, Oxford, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ballinger', 'Affiliation': 'Wessex Public Involvement Network (PIN), University of Southampton, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Kim Chivers', 'Initials': 'KC', 'LastName': 'Seymour', 'Affiliation': 'Faculty of Health Science, University of Southampton, Southampton, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23360']
1019,31302043,Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial.,"OBJECTIVES
This study sought to describe baseline health-related quality of life (HRQL) in the PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF) trial, the largest heart failure with preserved ejection fraction (HFpEF) trial to date.
BACKGROUND
There are limited data characterizing HRQL in patients with HFpEF using validated metrics.
METHODS
The PARAGON-HF trial randomized symptomatic patients with HFpEF (≥45%) ≥50 years of age to either sacubitril/valsartan or valsartan. The study reports comprehensive baseline HRQL using Kansas City Cardiomyopathy Questionnaire (KCCQ) administered at randomization after active run-in period. The study then compares baseline HRQL with patients with heart failure with reduced ejection fraction (HFrEF) (≤40%) enrolled in the PARADIGM-HF (Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. Forward multivariable stepwise regression modeling was performed separately in both trials to identify independent clinical correlates of KCCQ-Overall Summary (KCCQ-OS) score. PARADIGM-HF trial patients <50 years of age were excluded to enable comparison.
RESULTS
In the PARAGON-HF trial, 4,735 of 4,822 patients (mean age 73 ± 8 years; 48% men) completed baseline KCCQ at randomization. Mean KCCQ-OS score was 71. Women had worse mean KCCQ-OS score than men did. Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001). The strongest independent clinical correlates of adverse HRQL in both the PARAGON-HF and PARADIGM-HF trials were New York Heart Association functional class, female gender, lower extremity edema, body mass index, angina, dyspnea, and paroxysmal nocturnal dyspnea. After accounting for these clinical correlates of adverse HRQL that were common to both HFpEF and HFrEF patients, KCCQ-OS score did not differ significantly.
CONCLUSIONS
HRQL was largely worse in women and was similar in HFpEF and HFrEF after accounting for variation in demographics, functional status, and symptom burden. (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF [PARAGON-HF] NCT01920711; Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255).",2019,Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001).,"['HF trial patients', 'Heart Failure', 'patients with heart failure with reduced ejection fraction (HFrEF) (≤40%) enrolled in the PARADIGM-HF (Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart\xa0Failure) trial', '≥50 years of age to either', '50\xa0years of age were excluded to enable comparison', '4,735 of 4,822 patients (mean age 73 ± 8 years; 48% men) completed baseline KCCQ at randomization', 'symptomatic patients with HFpEF (≥45']","['Kansas City Cardiomyopathy Questionnaire (KCCQ', 'HFpEF', 'Fraction', 'sacubitril/valsartan or valsartan']","['KCCQ scores', 'KCCQ-OS score', 'Health-Related Quality of Life in Heart', 'baseline health-related quality of life (HRQL', 'mean KCCQ-OS score', 'Global Mortality and Morbidity', 'Mean KCCQ-OS score', 'adverse HRQL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",4822.0,0.186732,Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001).,"[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adel R', 'Initials': 'AR', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Victor C', 'Initials': 'VC', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Duke-National University of Singapore Medical School, Singapore; George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas; Imperial College London, London, United Kingdom.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine, Cardiology Charité, Universitaetsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany; German Heart Center, Berlin, Germany.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Institut de Cardiologie de Montréal, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Van Veldhuisen', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Inserm CIC 1433, French Clinical Research Infrastructure Network, Investigation Network Initiative Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régionale Universitaire de Nancy, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina; Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: ssolomon@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2019.05.015']
1020,31319427,Effects of Pre- and Post-Exercise Cold-Water Immersion Therapy on Passive Muscle Stiffness.,"BACKGROUND
Cold-water immersion (CWI) has become a popular preventive, regenerative and performance-enhancing intervention in various sports. However, its effects on soft tissue, including changes of intramuscular stiffness, are poorly understood. The purpose of this study was to investigate the effect of CWI on muscle stiffness.
PATIENTS/MATERIAL AND METHODS
Thirty healthy participants were included and divided into the three following groups (n = 10): 1) post-ESU group: exercise and CWI (post-exercise set-up); 2) control group: exercise without CWI (control condition); 3) pre-ESU group: CWI alone (pre-exercise set-up). Acoustic radiation force impulse (ARFI) elastography was conducted to assess tissue stiffness (shear wave velocity, SWV). Values obtained at resting conditions (baseline, t0) were compared to values post-exercise (t1, for post-ESU group and control group), post-CWI (t2, for post-ESU group and pre-ESU group; rest for control group) and to 60-min follow-up time (t3, for all groups). Data were assessed in superficial and deep muscle tissue (rectus femoris muscle, RF; vastus intermedius muscle, VI).
RESULTS
For the post-ESU group (CWI post-exercise), there was no significant difference between the time points of measurements: exercise (t1: RF: 1.63 m/s; VI: 1.54 m/s), CWI (t2: RF: 1.63 m/s; VI: 1.53 m/s) and at 60-min follow-up (t3: RF: 1.72 m/s; VI: 1.61 m/s). In the control group, a significant decrease of SWV was found between baseline conditions at t0 and post-exercise (t1) at VI (VI: 1.37 m/s; p = 0.004; RF: 1.59 m/s; p = 0.084). For t2 and t3, no further significant changes were detected. Regarding the pre-exercise set-up (pre-ESU group), a significant decrease in SWV from baseline to t2 in VI (1.60 m/s to 1.49 m/s; VI: p = 0.027) was found.
CONCLUSION
This study shows varying influences of CWI on muscle stiffness. Overall, we did not detect any significant effects of CWI on muscle stiffness post-exercise. Muscle stiffness-related effects of CWI differ in the context of a pre- or post-exercise condition and have to be considered in the implementation of CWI to ensure its potential preventive and regenerative benefits.",2020,"In the control group, a significant decrease of SWV was found between baseline conditions at t0 and post-exercise (t1) at VI (VI: 1.37 m/s; p = 0.004; RF: 1.59 m/s; p = 0.084).",['Thirty healthy participants'],"['Cold-water immersion (CWI', 'Acoustic radiation force impulse (ARFI) elastography', 'CWI', 'ESU group: exercise and CWI (post-exercise set-up); 2) control group: exercise without CWI (control condition); 3) pre-ESU group: CWI alone (pre-exercise set-up', 'Pre- and Post-Exercise Cold-Water Immersion Therapy']","['tissue stiffness (shear wave velocity, SWV', 'Passive Muscle Stiffness', 'superficial and deep muscle tissue (rectus femoris muscle, RF; vastus intermedius muscle, VI', 'SWV']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C1455736', 'cui_str': 'Acoustic radiations structure'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0584894', 'cui_str': 'Rectus Femoris'}, {'cui': 'C0224448', 'cui_str': 'Vastus Intermedius'}]",30.0,0.060789,"In the control group, a significant decrease of SWV was found between baseline conditions at t0 and post-exercise (t1) at VI (VI: 1.37 m/s; p = 0.004; RF: 1.59 m/s; p = 0.084).","[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Hüttel', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Golditz', 'Affiliation': 'Department of Orthopedic Trauma Surgery, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg Germany, Erlangen, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mayer', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Heiss', 'Affiliation': 'Department of Radiology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lutter', 'Affiliation': 'Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, Germany.'}, {'ForeName': 'Matthias Wilhelm', 'Initials': 'MW', 'LastName': 'Hoppe', 'Affiliation': 'Department of Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Department of Orthopedic, Trauma and Hand Surgery, Klinikum Osnabrück GmbH, Osnabrück, Germany.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Grim', 'Affiliation': 'Department of Orthopedic, Trauma and Hand Surgery, Klinikum Osnabrück GmbH, Osnabrück, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Seehaus', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Forst', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hotfiel', 'Affiliation': 'Department of Orthopedic Surgery, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}]",Sportverletzung Sportschaden : Organ der Gesellschaft fur Orthopadisch-Traumatologische Sportmedizin,['10.1055/a-0854-8302']
1021,31321524,PEG vs. sennosides for opioid-induced constipation in cancer care.,"PURPOSE
This randomized double-blind, double-dummy, 2-treatment, 2-period crossover study aimed to compare the efficacy and tolerability of polyethylene glycol (PEG) and sennosides in ambulatory cancer patients with opioid-induced constipation.
METHODS
Outpatients ≥ 18 years old with cancer, at risk of or already experiencing opioid-induced constipation, were randomly assigned to begin a standard bowel protocol of escalating doses of sennosides or PEG, plus a dummy preparation. After 3 weeks, the patients switched to the alternate active product and dummy preparation. Constipation was assessed using the revised Victoria Bowel Performance Scale (rBPS) at the end of each of the 2 consecutive 21-day study periods for the number of days with a satisfactory bowel movement, the time in days to goal rBPS (G), and the treatment preference of each patient.
RESULTS
Seventy patients were recruited, with 42 completing their first treatment period and 28 completing both treatment periods. For the typical patient, the expected number of days with a satisfactory bowel movement per days of treatment was found to be 1.21 times higher on PEG than on sennosides in a particular period (95% credible interval 0.96 to 1.55). Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94). There was no evidence of a difference in patient preference between laxatives.
CONCLUSION
Our study found weak evidence that PEG is superior to sennosides with respect to overall effectiveness in cancer patients with opioid-induced constipation.",2020,Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94).,"['18\xa0years old with cancer, at risk of or already experiencing opioid-induced constipation', 'Seventy patients were recruited, with 42 completing their first treatment period and 28 completing both treatment periods', 'cancer patients with opioid-induced constipation', 'Outpatients ≥', 'ambulatory cancer patients with opioid-induced constipation']","['polyethylene glycol (PEG) and sennosides', 'standard bowel protocol of escalating doses of sennosides or PEG, plus a dummy preparation', 'PEG']","['revised Victoria Bowel Performance Scale (rBPS', 'Constipation', 'efficacy and tolerability', 'rBPS of G']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3160897'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]","[{'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C3489575', 'cui_str': 'sennosides, USP'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0222045'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",70.0,0.113312,Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94).,"[{'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Hawley', 'Affiliation': 'Pain and Symptom Management/Palliative Care, British Columbia Cancer, 600 W 10th Ave, Vancouver, BC, V5Z 4E6, Canada. phawley@bccancer.bc.ca.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'MacKenzie', 'Affiliation': 'University of British Columbia, 317 - 2194 Health Sciences Mall, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gobbo', 'Affiliation': 'Pain and Symptom Management/Palliative Care, British Columbia Cancer, 600 W 10th Ave, Vancouver, BC, V5Z 4E6, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04944-5']
1022,31324354,Randomized Prospective Comparative Study of Adductor Canal Block vs Periarticular Infiltration on Early Functional Outcome After Unilateral Total Knee Arthroplasty.,"BACKGROUND
Total knee arthroplasty (TKA) is associated with significant postoperative pain. Effective pain relief is essential for early postoperative rehabilitation. Periarticular infiltration (PAI) and adductor canal block (ACB) have become popular modes of pain management after TKA. Our aim is to compare their efficacy and impact on early functional outcome in patients undergoing TKA.
METHODS
A single-blinded randomized controlled trial, 100 patients undergoing unilateral primary TKA for symptomatic osteoarthritis were allocated to either of the 2 groups (50 in each arm): postoperative ultrasound-guided single shot of ACB (group A) or intraoperative PAI (group B). All patients underwent TKA without patella resurfacing under spinal anesthesia. Preoperative workup, surgical technique, and postoperative management were standardized for all the patients. Patients were assessed for pain using visual analogue scale at 6, 12, and 24 hours after surgery; hemoglobin level preoperatively and postoperatively on day 1 to calculate blood loss; hospital stay; tourniquet time; operative time; and postoperative complications by an independent observer blinded to the group allocation.
RESULTS
Patients were matched for age, gender, American Society of Anesthesiologists grade, and deformity. Visual analogue scale (scale 0-10) between PAI and ACB at 6, 12, and 24 hours were significantly different (P < .05) with higher scores seen in patients with ACB at all time points. Tourniquet time and operative time were significantly longer in the PAI than ACB. No significant difference in hospital stay was observed. No complications occurred during the study.
CONCLUSION
PAI achieves better pain control as compared to ACB in patients undergoing unilateral TKA.",2019,Tourniquet time and operative time were significantly longer in the PAI than ACB.,"['patients undergoing unilateral TKA', 'Patients were matched for age, gender, American Society of Anesthesiologists grade, and deformity', '100 patients undergoing unilateral primary TKA for symptomatic osteoarthritis', 'patients undergoing TKA', 'After Unilateral Total Knee Arthroplasty']","['Adductor Canal Block vs Periarticular Infiltration', 'postoperative ultrasound-guided single shot of ACB (group A) or intraoperative PAI', 'ACB', 'Total knee arthroplasty (TKA', 'TKA without patella resurfacing under spinal anesthesia', 'PAI']","['hospital stay', 'Tourniquet time and operative time', 'complications', 'Visual analogue scale', 'pain using visual analogue scale', 'blood loss; hospital stay; tourniquet time; operative time; and postoperative complications', 'Early Functional Outcome', 'Periarticular infiltration (PAI) and adductor canal block (ACB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation (observable entity)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",100.0,0.0627325,Tourniquet time and operative time were significantly longer in the PAI than ACB.,"[{'ForeName': 'Mahesh M', 'Initials': 'MM', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Ankit N', 'Initials': 'AN', 'LastName': 'Dadheech', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Hemant M', 'Initials': 'HM', 'LastName': 'Wakankar', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Niranjan V', 'Initials': 'NV', 'LastName': 'Ganjewar', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Snehal S', 'Initials': 'SS', 'LastName': 'Hedgire', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Hemant G', 'Initials': 'HG', 'LastName': 'Pandit', 'Affiliation': 'LEEDS Institute of Rheumatic and Musculoskeletal Medicine, University of LEEDS, Leeds, UK.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.05.049']
1023,32491941,Effect of computer-assisted-learning and simulation clinics on dental students' cognitive and performance skills: panoramic image errors related to patient's head position.,"OBJECTIVE
To assess dental students' ability to recognize head positioning errors in panoramic (PAN) images after individual learning via computer-assisted-learning (CAL) and in a simulation clinic (SIM). Both cognitive skills and performance in patient examination were assessed.
METHODS AND MATERIALS
Sixty students (mean age 23.25 years) participated in lectures on the relation between PAN-image errors and patient's head position.Immediately after they took a test, based on which they were randomized to three groups: control (CON)group, CAL group, and SIM group (both CAL and training in a simulation clinic with a phantom). Four-to-five weeks after intervention/no intervention, all students individually examined a patient with PAN-exposure. A blinded rater, not knowing group allocation, supervised patient exposure and assessed student's performance (correct/incorrect head position in three planes). One-to-two weeks after, the students scored positioning errors in 40 PAN-images. Differences in cognitive test scores between groups were evaluated by ANOVA and in patient examination by chi-square tests, and within-group differences by sign-tests.
RESULTS
No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p < 0.003). In all groups, several students positioned the patient incorrectly in the Frankfort horizontal plane. All students performed well in the sagittal plane. Students in SIM group positioned the patient more correctly in the coronal plane.
CONCLUSIONS
Training with computer-assisted-learning increased students' cognitive skills compared with a control group. Simulated patient exposure with a phantom increased to some extent their performance skills in examination of patients.",2020,"No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p < 0.003).","[""dental students' cognitive and performance skills"", ""Sixty students (mean age 23.25 years) participated in lectures on the relation between PAN-image errors and patient's head position""]","['control (CON)group, CAL group, and SIM group (both CAL and training in a simulation clinic with a phantom', 'individual learning via computer-assisted-learning (CAL', 'computer-assisted-learning and simulation clinics', 'CON', 'Training with computer-assisted-learning']","[""students' cognitive skills"", 'cognitive test scores']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582540', 'cui_str': 'Head position finding'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0253438,"No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p < 0.003).","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Wenzel', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Louise Hauge', 'Initials': 'LH', 'LastName': 'Matzen', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Spin-Neto', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schropp', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}]",Dento maxillo facial radiology,['10.1259/dmfr.20200154']
1024,31320006,"Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial.","OBJECTIVES
This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation.
BACKGROUND
The vHPSD catheter is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions.
METHODS
QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation.
RESULTS
A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits.
CONCLUSIONS
This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation [QDOT-FAST]; NCT03459196).",2019,"There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects.","['Patients', 'Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits', 'patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation', '52 patients underwent ablation and completed follow-up', 'Patients With Paroxysmal Atrial Fibrillation', 'Temperature-Controlled Lesions']","['novel catheter for very high power-short duration (vHPSD) ablation', 'vHPSD ablation', 'Fast Ablation Mode']","['Pulmonary vein isolation', 'Pulmonary Vein Isolation', 'deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects', 'asymptomatic thromboembolism', 'short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events', 'Procedure and fluoroscopy times']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0340756', 'cui_str': 'Stenosis, Pulmonary Vein'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of (contextual qualifier) (qualifier value)'}, {'cui': 'C0337095', 'cui_str': 'Entrance (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034090', 'cui_str': 'Vein of lung'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0022245', 'cui_str': 'isoprenaline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",90.0,0.0279694,"There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects.","[{'ForeName': 'Vivek Y', 'Initials': 'VY', 'LastName': 'Reddy', 'Affiliation': 'Cardiac Electrophysiology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic. Electronic address: vivek.reddy@mountsinai.org.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Grimaldi', 'Affiliation': 'Department of Cardiology, Ospedale Generale Regionale F. Muilli, Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'De Potter', 'Affiliation': 'Cardiovascular Center, Onze Lieve Vrouwziekenhuis, Hospital, Aalst, Belgium.'}, {'ForeName': 'Johan M', 'Initials': 'JM', 'LastName': 'Vijgen', 'Affiliation': 'Hasselt Heart Center, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Bulava', 'Affiliation': 'Department of Cardiology, Ceske Budejovice Hospital, Faculty of Health and Social Sciences, University of South Bohemia in Ceske Budejovice, Ceske Budejovice, Czech Republic.'}, {'ForeName': 'Mattias Francis', 'Initials': 'MF', 'LastName': 'Duytschaever', 'Affiliation': 'Department of Cardiology, Algemeen Ziekenhuis Sint Jan, Bruges, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Martinek', 'Affiliation': 'Department of Cardiology, Ordensklinikum Linz Elisabethinen, Linz, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natale', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas.""}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Knecht', 'Affiliation': 'Department of Cardiology, Algemeen Ziekenhuis Sint Jan, Bruges, Belgium.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Neuzil', 'Affiliation': 'Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Pürerfellner', 'Affiliation': 'Department of Cardiology, Ordensklinikum Linz Elisabethinen, Linz, Austria.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.04.009']
1025,32491964,"Treatment of myofascial pain with a rapid laser therapy protocol compared to occlusal splint: A double-blind, randomized clinical trial.","OBJECTIVE
To compare the effect of a rapid low-level laser therapy (LLLT) protocol to Michigan occlusal splint in the treatment of myofascial pain, as well as to evaluate their impact on Oral Health-Related Quality of Life (OHRQoL).
METHODS
Thirty participants were randomly allocated into three groups: G1: occlusal splint (n = 11), G2: LLLT (n = 10), and G3: LLLT placebo (n = 9). LLLT and placebo were applied in the points of pain upon palpation.
RESULTS
G1 presented improvement in pain ( p = 0.014) and in the diagnosis of myofascial pain ( p = 0.008), while G2 and G3 did not. Regarding OHRQoL, G1 and G2 presented significant improvement ( p = 0.005, in both), whereas, G3 did not.
CONCLUSION
Michigan occlusal splint was effective in reducing pain and improving OHRQoL. Treatment with the rapid LLLT protocol only provided an improvement in OHRQoL.",2020,"Regarding OHRQoL, G1 and G2 presented significant improvement ( p = 0.005, in both), whereas, G3 did not.
",['Thirty participants'],"['occlusal splint', 'rapid laser therapy protocol', 'G3: LLLT placebo', 'LLLT and placebo', 'G1: occlusal splint (n\xa0=\xa011), G2: LLLT', 'Michigan occlusal splint', 'rapid low-level laser therapy (LLLT) protocol to Michigan occlusal splint']","['Oral Health-Related Quality of Life (OHRQoL', 'pain and improving OHRQoL', 'diagnosis of myofascial pain', 'myofascial pain', 'OHRQoL', 'pain']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}]",30.0,0.398388,"Regarding OHRQoL, G1 and G2 presented significant improvement ( p = 0.005, in both), whereas, G3 did not.
","[{'ForeName': 'Lucas Machado', 'Initials': 'LM', 'LastName': 'Maracci', 'Affiliation': ""Federal University of Santa Maria , Sant'Ana do Livramento, RS, Brazil.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Stasiak', 'Affiliation': ""Federal University of Santa Maria , Sant'Ana do Livramento, RS, Brazil.""}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'de Oliveira Chami', 'Affiliation': 'Dental Sciences, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Gisele Jung', 'Initials': 'GJ', 'LastName': 'Franciscatto', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Milanesi', 'Affiliation': 'Private Practice, Volunteer at Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'Figueiró', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Bernardon', 'Affiliation': 'Department of Stomatology, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Magáli Beck', 'Initials': 'MB', 'LastName': 'Guimarães', 'Affiliation': 'Department of Stomatology, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Marquezan', 'Affiliation': 'Department of Stomatology, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2020.1773661']
1026,31325122,"Intraoral photobiomodulation diminishes pain and improves functioning in women with temporomandibular disorder: a randomized, sham-controlled, double-blind clinical trial : Intraoral photobiomodulation diminishes pain in women with temporomandibular disorder.","The aim of the present study was to evaluate the effect of intraoral photobiomodulation involving super-pulsed laser (905 nm) combined with red (640 nm) and infrared (875 nm) light-emitting diodes on pain, mandibular range of motion, and functioning in women with myogenous temporomandibular disorder. A randomized, sham-controlled, double-blind clinical trial was conducted involving 30 women with myogenous temporomandibular disorder diagnosed using the Research Diagnostic Criteria for Temporomandibular Disorders. The participants were randomly allocated to two groups (active and sham photobiomodulation). The evaluations involved this use of the visual analog scale, digital calipers, and a functional scale. Photobiomodulation was administered intraorally in the region of the pterygoid muscles, bilaterally, in all participants for a total of six sessions. Evaluations were performed on five occasions: prior to the intervention, immediately after the first session, 24 h and 48 h after the first session, and after the six sessions. Significant differences between groups were found regarding pain (p ≤ 0.01) and functioning (p ≤ 0.04). However, no statistically significant difference was found regarding range of mandibular motion. The findings demonstrate that intraoral photobiomodulation involving super-pulsed laser (905 nm) combined with red (640 nm) and infrared (875 nm) light-emitting diodes diminishes pain and improves functioning but does not exert an influence on mandibular range of motion in women with temporomandibular disorder.Trial registration: NCT02839967.",2020,Significant differences between groups were found regarding pain (p ≤ 0.01) and functioning (p ≤ 0.04).,"['30 women with myogenous temporomandibular disorder diagnosed using the Research Diagnostic Criteria for Temporomandibular Disorders', 'women with myogenous temporomandibular disorder', 'women with temporomandibular disorder']","['intraoral photobiomodulation involving super-pulsed laser (905\xa0nm) combined with red (640\xa0nm) and infrared (875\xa0nm) light-emitting diodes', 'Intraoral photobiomodulation']","['pain, mandibular range of motion, and functioning', 'range of mandibular motion', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0035168'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0442119', 'cui_str': 'Intraoral approach (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1289905', 'cui_str': 'Pulsed laser'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C1532326', 'cui_str': 'Infrared'}, {'cui': 'C4517897', 'cui_str': '875'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}]",30.0,0.505167,Significant differences between groups were found regarding pain (p ≤ 0.01) and functioning (p ≤ 0.04).,"[{'ForeName': 'Carolina Marciela', 'Initials': 'CM', 'LastName': 'Herpich', 'Affiliation': 'Department of Physical Therapy, University Nove de Julho, São Paulo, Brazil. carolinaherpich@gmail.com.'}, {'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Department of Postgraduate Program in Rehabilitation Sciences, University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Politti', 'Affiliation': 'Department of Postgraduate Program in Rehabilitation Sciences, University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Cid André Fidelis', 'Initials': 'CAF', 'LastName': 'de Paula Gomes', 'Affiliation': 'Department of Physical Therapy, University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Igor Phillip', 'Initials': 'IP', 'LastName': 'Dos Santos Glória', 'Affiliation': 'Department of Postgraduate Program in Rehabilitation Sciences, University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Maitê de Freitas Rocha', 'Initials': 'MFR', 'LastName': 'de Souza Amaral', 'Affiliation': 'Department of Postgraduate Program in Rehabilitation Sciences, University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Graciela', 'Initials': 'G', 'LastName': 'Herpich', 'Affiliation': 'Department of Postgraduate Program in Rehabilitation Sciences, University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Ludmila Menezes Alves', 'Initials': 'LMA', 'LastName': 'de Azevedo', 'Affiliation': 'Department of Postgraduate Program in Rehabilitation Sciences, University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Tabajara', 'Initials': 'T', 'LastName': 'de Oliveira Gonzalez', 'Affiliation': 'Department of Physical Therapy, University Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'Daniela Aparecida', 'Initials': 'DA', 'LastName': 'Biasotto-Gonzalez', 'Affiliation': 'Department of Postgraduate Program in Rehabilitation Sciences, University Nove de Julho, São Paulo, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02841-1']
1027,30633980,Intrauterine Device Insertion Procedure Duration in Adolescent and Young Adult Women.,"STUDY OBJECTIVE
Intrauterine device (IUD) utilization in the United States is low among adolescent and young adult women. Longer procedure duration has been proposed as one potential barrier to IUD insertion in this population. We hypothesized that procedure duration would be longer in adolescents compared to young adult women.
DESIGN, SETTING, AND PARTICIPANTS
This study was a secondary analysis of a randomized clinical trial comparing the effectiveness of a lidocaine vs sham paracervical nerve block for pain control during levonorgestrel 13.5 mg IUD insertion. Adolescent and young adult women ages 14-22 years were recruited from 3 outpatient academic sites in Philadelphia, Pennsylvania.
INTERVENTIONS AND MAIN OUTCOME MEASURES
Pain scores were recorded at 7 steps during the procedure from speculum insertion through removal. Time stamps associated with each step were used to calculate the overall procedure duration. Cumulative IUD insertion procedure duration was estimated using the Kaplan-Meier method.
RESULTS
Ninety-five women enrolled. Nineteen (19/95, 20%) were ages 14-17 and 76 (76/95, 80%) were ages 18-22 years. The median procedure duration (seconds ± interquartile range) was longer for adolescents than for young adults (555 ± 428 seconds vs 383 ± 196 seconds; P = .008). After adjusting for study site, the difference in expected median procedure duration between age groups was not significant (P = .3832).
CONCLUSION
The difference in duration of IUD insertion procedures in adolescent and young adult women is not clinically or statistically significant. Providers should not withhold IUDs from appropriate adolescent and young adult women on the basis of age alone.",2019,"After adjusting for study site, the difference in expected median procedure duration between age groups was not significant (P = .3832).
","['Adolescent and young adult women ages 14-22\xa0years were recruited from 3 outpatient academic sites in Philadelphia, Pennsylvania', 'Nineteen (19/95, 20%) were ages 14-17 and 76 (76/95, 80%) were ages 18-22\xa0years', 'Adolescent and Young Adult Women', 'Ninety-five women enrolled', 'adolescent and young adult women']","['Intrauterine Device Insertion Procedure Duration', 'lidocaine vs sham paracervical nerve block', 'levonorgestrel 13.5\xa0mg IUD insertion']","['Pain scores', 'median procedure duration (seconds\xa0±\xa0interquartile range', 'duration of IUD insertion procedures', 'Cumulative IUD insertion procedure duration', 'median procedure duration']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C4517906', 'cui_str': '95'}]","[{'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0030401', 'cui_str': 'Paracervical Block'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",95.0,0.379381,"After adjusting for study site, the difference in expected median procedure duration between age groups was not significant (P = .3832).
","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': ""O'Flynn O'Brien"", 'Affiliation': 'Department of Obstetrics and Gynecology, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: katherio@bcm.edu.'}, {'ForeName': 'Aletha Y', 'Initials': 'AY', 'LastName': 'Akers', 'Affiliation': ""Craig Dalsimer Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Perriera', 'Affiliation': 'Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Obstetrics and Gynecology, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'J Felipe', 'Initials': 'JF', 'LastName': 'Garcia-Espana', 'Affiliation': ""Children's Hospital of Philadelphia Research Institute, Philadelphia, Pennsylvania.""}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': 'Department of Obstetrics and Gynecology, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Journal of pediatric and adolescent gynecology,['10.1016/j.jpag.2019.01.002']
1028,32491956,Rapid LLLT protocol for myofascial pain and mouth opening limitation treatment in the clinical practice: An RCT.,"OBJECTIVE
To evaluate the effect of a rapid treatment protocol of low-level laser therapy (LLLT) in patients with myofascial pain and mouth opening limitation.
METHODS
Twenty patients were randomly allocated into the laser group (LG) (n = 10) and the placebo group (PG) (n = 10). Two LLLT sessions or placebo were performed. They were applied to the pain points upon palpation, with a 48-hr interval. Patients were evaluated for spontaneous pain sensitivity during mandibular movements and for oral health-related quality of life, which was assessed using the Oral Health Impact Profile for Temporomandibular Disorders (OHIP/TMD) questionnaire.
RESULTS
Two patients from the placebo group were lost during the study. A significant increase in the maximum mouth opening ( p = 0.04) and improvement in OHIP/TMD scores ( p = 0.003) were observed in the LG after 30 days.
CONCLUSION
Spontaneous pain was reduced in both groups with low-level laser therapy.",2020,"A significant increase in the maximum mouth opening ( p = 0.04) and improvement in OHIP/TMD scores ( p = 0.003) were observed in the LG after 30 days.
","['patients with myofascial pain and mouth opening limitation', 'Twenty patients']","['Rapid LLLT protocol', 'low-level laser therapy (LLLT', 'laser group (LG', 'placebo']","['spontaneous pain sensitivity', 'maximum mouth opening', 'Oral Health Impact Profile for Temporomandibular Disorders (OHIP/TMD) questionnaire', 'Spontaneous pain', 'OHIP/TMD scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.410225,"A significant increase in the maximum mouth opening ( p = 0.04) and improvement in OHIP/TMD scores ( p = 0.003) were observed in the LG after 30 days.
","[{'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'De Oliveira Chami', 'Affiliation': 'Dental Sciences, Federal University of Santa Maria , Santa Maria, Brazil.'}, {'ForeName': 'Lucas Machado', 'Initials': 'LM', 'LastName': 'Maracci', 'Affiliation': 'Dental Sciences, Federal University of Santa Maria , Santa Maria, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Tomazoni', 'Affiliation': 'Department of Physiology, Federal University of Santa Maria , Santa Maria, Brazil.'}, {'ForeName': 'Anna Carolina Teixeira', 'Initials': 'ACT', 'LastName': 'Centeno', 'Affiliation': 'Dental Sciences, Federal University of Santa Maria , Santa Maria, Brazil.'}, {'ForeName': 'André Luiz', 'Initials': 'AL', 'LastName': 'Porporatti', 'Affiliation': 'Department of Dentistry, Federal University of Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Vilmar Antônio', 'Initials': 'VA', 'LastName': 'Ferrazzo', 'Affiliation': 'Department of Stomatology, Federal University of Santa Maria , Santa Maria, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Marquezan', 'Affiliation': 'Department of Stomatology, Federal University of Santa Maria , Santa Maria, Brazil.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2020.1773660']
1029,32492041,Corrected analysis of 'Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial' confirms conclusions.,,2020,,['American Indian adolescents'],[],[],"[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],[],,0.100604,,"[{'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Golzarri-Arroyo', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}, {'ForeName': 'Xiwei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dickinson', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Short', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}]",PloS one,['10.1371/journal.pone.0233273']
1030,31303184,Iron status and inherited haemoglobin disorders modify the effects of micronutrient powders on linear growth and morbidity among young Lao children in a double-blind randomised trial.,"Some studies found that providing micronutrient powder (MNP) causes adverse health outcomes, but modifying factors are unknown. We aimed to investigate whether Fe status and inherited Hb disorders (IHbD) modify the impact of MNP on growth and diarrhoea among young Lao children. In a double-blind controlled trial, 1704 children of age 6-23 months were randomised to daily MNP (with 6 mg Fe plus fourteen micronutrients) or placebo for about 36 weeks. IHbD, and baseline and final Hb, Fe status and anthropometrics were assessed. Caregivers provided weekly morbidity reports. At enrolment, 55·6 % were anaemic; only 39·3 % had no sign of clinically significant IHbD. MNP had no overall impact on growth and longitudinal diarrhoea prevalence. Baseline Hb modified the effect of MNP on length-for-age (LAZ) (P for interaction = 0·082). Among children who were initially non-anaemic, the final mean LAZ in the MNP group was slightly lower (-1·93 (95 % CI -1·88, -1·97)) v. placebo (-1·88 (95 % CI -1·83, -1·92)), and the opposite occurred among initially anaemic children (final mean LAZ -1·90 (95 % CI -1·86, -1·94) in MNP v. -1·92 (95 % CI -1·88, -1·96) in placebo). IHbD modified the effect on diarrhoea prevalence (P = 0·095). Among children with IHbD, the MNP group had higher diarrhoea prevalence (1·37 (95 % CI 1·17, 1·59) v. 1·21 (95 % CI 1·04, 1·41)), while it was lower among children without IHbD who received MNP (1·15 (95 % CI 0·95, 1·39) v. 1·37 (95 % CI 1·13, 1·64)). In conclusion, there was a small adverse effect of MNP on growth among non-anaemic children and on diarrhoea prevalence among children with IHbD.",2019,"Among children with IHbD, the MNP group had higher diarrhea prevalence (1.37 (95%CI: 1.17, 1.59) vs. 1.21 (95%CI: 1.04, 1.41)), while it was lower among children without IHbD who received MNP (1.15 (95%CI: 0.95, 1.39) vs. 1.37 (95%CI: 1.13, 1.64)).","['Young Lao Children', 'children with IHbD', '1704 children ages 6-23mo', 'young Lao children']","['placebo', 'micronutrient powder (MNP', '95%CI', 'daily MNP (with 6mg iron plus 14 micronutrients) or placebo', 'Micronutrient Powders', 'MNP']","['Linear Growth and Morbidity', 'IHbD, and baseline and final hemoglobin (Hb), iron status, and anthropometrics', 'growth and longitudinal diarrhea prevalence', 'growth and diarrhea', 'diarrhea prevalence']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0534702', 'cui_str': 'lanthanum oxide'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",1704.0,0.679542,"Among children with IHbD, the MNP group had higher diarrhea prevalence (1.37 (95%CI: 1.17, 1.59) vs. 1.21 (95%CI: 1.04, 1.41)), while it was lower among children without IHbD who received MNP (1.15 (95%CI: 0.95, 1.39) vs. 1.37 (95%CI: 1.13, 1.64)).","[{'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Sanchaisuriya', 'Affiliation': 'Center for Research and Development of Medical Diagnostic Laboratories, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Brown', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Larson', 'Affiliation': 'Canadian Coalition for Global Health Research, Ottawa, Canada.'}, {'ForeName': 'Supan', 'Initials': 'S', 'LastName': 'Fucharoen', 'Affiliation': 'Center for Research and Development of Medical Diagnostic Laboratories, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}]",The British journal of nutrition,['10.1017/S0007114519001715']
1031,31904578,"A Web- and Mobile App-Based Mental Health Promotion Intervention Comparing Email, Short Message Service, and Videoconferencing Support for a Healthy Cohort: Randomized Comparative Study.","BACKGROUND
The rapid increase in mental health disorders has prompted a call for greater focus on mental health promotion and primary prevention. Web- and mobile app-based interventions present a scalable opportunity. Little is known about the influence of human support on the outcomes of these interventions.
OBJECTIVE
This study aimed to compare the influence of 3 modes of human support on the outcomes (ie, mental health, vitality, depression, anxiety, stress, life satisfaction, and flourishing) of a 10-week, Web- and mobile app-based, lifestyle-focused mental health promotion intervention among a healthy adult cohort.
METHODS
Participants were recruited voluntarily using a combination of online and offline advertising. They were randomized, unblinded into 3 groups differentiated by human support mode: Group 1 (n=201): standard-fully automated emails (S); Group 2 (n=202): standard plus personalized SMS (S+pSMS); and Group 3 (n=202): standard plus weekly videoconferencing support (S+VCS), hosted by 1 trained facilitator. Participants accessed the intervention, including the questionnaire, on a Web-based learning management system or through a mobile app. The questionnaire, administered at pre- and postintervention, contained self-reported measures of mental well-being, including the ""mental health"" and ""vitality"" subscales from the Short Form Health Survey-36, Depression Anxiety and Stress Scale-21, Diener Satisfaction With Life Scale (SWLS), and Diener Flourishing Scale.
RESULTS
Of 605 potential participants, 458 (S: n=157, S+pSMS: n=163, and S+VCS: n=138) entered the study by completing registration and the preintervention questionnaire. At post intervention, 320 out of 458 participants (69.9%; S: n=103, S+pSMS: n=114, and S+VCS: n=103) completed the questionnaire. Significant within-group improvements were recorded from pre- to postintervention in all groups and in every outcome measure (P≤.001). No significant between-group differences were observed for outcomes in any measure: mental health (P=.77), vitality (P=.65), depression (P=.93), anxiety (P=.25), stress (P.57), SWLS (P=.65), and Flourishing Scale (P=.99). Adherence was not significantly different between groups for mean videos watched (P=.42) and practical activity engagement (P=.71). Participation in videoconference support sessions (VCSSs) was low; 37 out of 103 (35.9%) participants did not attend any VCSSs, and only 19 out of 103 (18.4%) attended 7 or more out of 10 sessions. Stratification within the S+VCS group revealed that those who attended 7 or more VCSSs experienced significantly greater improvements in the domains of mental health (P=.006; d=0.71), vitality (P=.005; d=0.73), depression (P=.04; d=0.54), and life satisfaction (P=.046; d=0.50) compared with participants who attended less than 7.
CONCLUSIONS
A Web- and mobile app-based mental health promotion intervention enhanced domains of mental well-being among a healthy cohort, irrespective of human support. Low attendance at VCSSs hindered the ability to make meaningful between-group comparisons. Supplementing the intervention with VCSSs might improve outcomes when attendance is optimized.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ANZCTR): 12619001009101; http://www.anzctr.org.au/ACTRN12619001009101.aspx.",2020,Adherence was not significantly different between groups for mean videos watched (P=.42) and practical activity engagement (P=.71).,"['320 out of 458 participants (69.9%; S: n=103, S+pSMS: n=114, and S+VCS: n=103) completed the questionnaire', 'Healthy Cohort', 'mental health disorders', 'Of 605 potential participants, 458 (S: n=157, S+pSMS: n=163, and S+VCS: n=138) entered the study by completing registration and the preintervention questionnaire', 'healthy adult cohort', 'Participants were recruited voluntarily using a combination of online and offline advertising']","['ANZCTR', 'Web- and Mobile App-Based Mental Health Promotion Intervention', 'Web- and mobile app-based mental health promotion intervention', 'standard-fully automated emails (S); Group 2 (n=202): standard plus personalized SMS (S+pSMS); and Group 3 (n=202): standard plus weekly videoconferencing support (S+VCS), hosted by 1 trained facilitator', 'Web- and mobile app-based, lifestyle-focused mental health promotion intervention']","['vitality', 'practical activity engagement', 'depression', 'measure: mental health', 'Adherence', 'domains of mental health', 'vitality (P=.65), depression (P=.93), anxiety (P=.25), stress (P.57), SWLS (P=.65), and Flourishing Scale', 'outcomes (ie, mental health, vitality, depression, anxiety, stress, life satisfaction, and flourishing', 'life satisfaction', 'mental health"" and ""vitality"" subscales from the Short Form Health Survey-36, Depression Anxiety and Stress Scale-21, Diener Satisfaction With Life Scale (SWLS), and Diener Flourishing Scale']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale (assessment scale)'}]",458.0,0.0875452,Adherence was not significantly different between groups for mean videos watched (P=.42) and practical activity engagement (P=.71).,"[{'ForeName': 'Melanie Elise', 'Initials': 'ME', 'LastName': 'Renfrew', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, New South Wales, Australia.'}, {'ForeName': 'Darren Peter', 'Initials': 'DP', 'LastName': 'Morton', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, New South Wales, Australia.'}, {'ForeName': 'Jason Kyle', 'Initials': 'JK', 'LastName': 'Morton', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, New South Wales, Australia.'}, {'ForeName': 'Jason Scott', 'Initials': 'JS', 'LastName': 'Hinze', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, New South Wales, Australia.'}, {'ForeName': 'Peter James', 'Initials': 'PJ', 'LastName': 'Beamish', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, New South Wales, Australia.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Przybylko', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, New South Wales, Australia.'}, {'ForeName': 'Bevan Adrian', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Lifestyle and Health Research Centre, Avondale University College, Cooranbong, New South Wales, Australia.'}]",Journal of medical Internet research,['10.2196/15592']
1032,31302023,Caring efficacy to improve nurses' caring behavior.,"OBJECTIVE
This study aimed to assess how caring efficacy training influences the nurses' caring behavior of two hospitals in Riau province, Indonesia.
METHOD
A quasi-experimental, pre-posttest with control group design was used in this study. 50 nurses of X hospital were assigned in the intervention group while another cohort of 50 nurses from Y hospital was allocated for the control group. Both groups had a baseline measurement of caring behavior. A training on caring efficacy was given followed by evaluation at two-time points for the intervention group.
RESULTS
There was a significant difference between the caring behavior of the nurses in the intervention and control group after the caring efficacy training (p-value=0.0001). In addition, knowledge was found to be linked with the caring behavior of the nurses (r=0.20, p=0.04).
CONCLUSIONS
Caring efficacy training is likely to be associated with the nurses' caring behavior and knowledge.",2019,There was a significant difference between the caring behavior of the nurses in the intervention and control group after the caring efficacy training (p-value=0.0001).,"[""nurses' caring behavior of two hospitals in Riau province, Indonesia"", '50 nurses of X hospital were assigned in the intervention group while another cohort of 50 nurses from Y hospital was allocated for the control group']",[],['caring behavior'],"[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior'}]",50.0,0.0263421,There was a significant difference between the caring behavior of the nurses in the intervention and control group after the caring efficacy training (p-value=0.0001).,"[{'ForeName': 'Santi', 'Initials': 'S', 'LastName': 'Surbakti', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia; Dumai City Hospital, Dumai, Riau, Indonesia.'}, {'ForeName': 'Enie', 'Initials': 'E', 'LastName': 'Novieastari', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: enie@ui.ac.id.'}, {'ForeName': 'Tuti', 'Initials': 'T', 'LastName': 'Nuraini', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.04.107']
1033,31305281,"Carvedilol Combined With Ivabradine Improves Left Ventricular Diastolic Dysfunction, Clinical Progression, and Survival in Cirrhosis.","BACKGROUND
Left ventricular diastolic dysfunction (LVDD) refers to impaired cardiac diastolic relaxation and may be improved by targeted heart rate reduction (THR). The authors evaluated whether a combination of carvedilol and ivabradine, an If channel blocker that reduces heart rate without affecting blood pressure, could improve LVDD and outcomes in cirrhosis.
PATIENTS AND METHODS
THR was defined as heart rate reduction to 55 to 65 beats per minute. Of 260 patients with cirrhosis, 189 (72%) with LVDD were randomized to THR [group (Gr.)A; n=94; carvedilol±ivabradine)] or standard care (Gr.B; n=95; no β-blockers) and followed for 12 months.
RESULTS
In Gr.A, THR was achieved at 4 weeks in 88 (93%) patients (responders, R): 48 (61.5%) with carvedilol alone and 40 (86.9%) of 46 patients with additional ivabradine. In Gr.A, LVDD reversed in 16 (20.5%) and improved from grade 2 to 1 in 34 (35.4%)], whereas in Gr.B, it progressed from grade 1 to 2 in 10 (10.5%) patients. At 12 months, 21 (11.1%) patients died, 6 (14%) in Gr.A and 15 (18%) in Gr.B (P=0.240), but no mortality was seen in those who had persistent THR at 1 year (n=78; P=0.000). In multivariate analysis, model for end-stage liver disease [hazard ratio (HR), 1.52; 95% confidence interval (CI), 1.22-2.75; P=0.034] and E-wave transmitral/early diastolic mitral annular velocity (HR, 1.28; 95% CI, 1.23-2.42; P=0.048) predicted 1-year mortality. Nonresponders had an increased mortality risk (HR, 1.3; 95% CI, 1.2-1.8; P=0.046) independent of age, gender, and baseline model for end-stage liver disease. Levels of norepinephrine, N terminal brain natriuretic peptide, plasma renin activity, and aldosterone were reduced (P<0.01) in responders. More patients in Gr.B developed acute kidney injury (odds ratio, 4.2; 95% CI, 2.8-10.5; P=0.027) and encephalopathy (odds ratio, 6.6; 95% CI, 1.9-9.7; P=0.040).
CONCLUSIONS
Ivabradine combined with carvedilol improves LVDD, achieves THR more often and reduces risk of encephalopathy, acute kidney injury with improved survival in patients with cirrhosis.",2020,"Levels of norepinephrine, N terminal brain natriuretic peptide, plasma renin activity, and aldosterone were reduced (P<0.01) in responders.","['260 patients with cirrhosis, 189 (72%) with LVDD', 'patients with cirrhosis', '46 patients with additional ivabradine']","['Carvedilol Combined With Ivabradine', 'Ivabradine combined with carvedilol', 'THR', 'carvedilol±ivabradine)] or standard care (Gr.B; n=95; no β-blockers', 'carvedilol', 'carvedilol and ivabradine', 'channel blocker']","['LVDD', 'no mortality', 'E-wave transmitral/early diastolic mitral annular velocity', 'heart rate without affecting blood pressure', 'heart rate reduction', '1-year mortality', 'Levels of norepinephrine, N terminal brain natriuretic peptide, plasma renin activity, and aldosterone', 'THR', 'acute kidney injury', 'mortality risk', 'Left Ventricular Diastolic Dysfunction, Clinical Progression, and Survival in Cirrhosis', 'encephalopathy']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4301608', 'cui_str': 'carvedilol and ivabradine'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1273070', 'cui_str': 'Left ventricular diastolic dysfunction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathies'}]",260.0,0.28365,"Levels of norepinephrine, N terminal brain natriuretic peptide, plasma renin activity, and aldosterone were reduced (P<0.01) in responders.","[{'ForeName': 'Madhumita', 'Initials': 'M', 'LastName': 'Premkumar', 'Affiliation': 'Departments of Hepatology.'}, {'ForeName': 'Devaraja', 'Initials': 'D', 'LastName': 'Rangegowda', 'Affiliation': 'Departments of Hepatology.'}, {'ForeName': 'Tanmay', 'Initials': 'T', 'LastName': 'Vyas', 'Affiliation': 'Departments of Hepatology.'}, {'ForeName': 'Jelen S', 'Initials': 'JS', 'LastName': 'Khumuckham', 'Affiliation': 'Cardiology.'}, {'ForeName': 'Saggere M', 'Initials': 'SM', 'LastName': 'Shasthry', 'Affiliation': 'Departments of Hepatology.'}, {'ForeName': 'Sherin S', 'Initials': 'SS', 'LastName': 'Thomas', 'Affiliation': 'Biochemistry.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Goyal', 'Affiliation': 'Biochemistry.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Epidemiology, Institute of Liver and Biliary Sciences, New Delhi.'}, {'ForeName': 'Shiv K', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Departments of Hepatology.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001219']
1034,30791735,"Long-Term Changes of Symptoms of Anxiety, Depression, and Fatigue in Cancer Patients 6 Months After the End of Yoga Therapy.","BACKGROUND
Symptoms of anxiety, depression, and cancer-related fatigue are commonly associated with cancer. Cancer patients increasingly use complementary and alternative treatments, such as yoga, to cope with psychological and physical impairments. In the present article, long-term changes of anxiety, depression, and fatigue in cancer are examined 6 months after a yoga intervention.
METHOD
We used an observational design based on a randomized controlled study in cancer patients with mixed diagnoses to evaluate long-term changes of symptoms of anxiety, depression, and fatigue 6 months after the end of yoga therapy. We measured anxiety symptoms with the Generalized Anxiety Disorder scale (GAD-7), depressive symptoms with the Patient Health Questionnaire-2 (PHQ-2), and fatigue with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Fatigue Scale (EORTC QLQ-FA13). Yoga therapy was provided in yoga classes of 60 minutes each once a week for 8 weeks in total. The exercises provided contained both body and breathing activities as well as meditation.
RESULTS
A total of 58 patients participated in the study. Six months after the end of yoga therapy, symptoms of anxiety, depression, and fatigue were significantly reduced compared with baseline. However, symptoms of anxiety and fatigue slightly increased during the follow-up period, whereas symptoms of depression remained stable.
CONCLUSION
Our results are promising and support the integration of yoga interventions in supportive cancer treatment concepts but should be confirmed by randomized controlled trials. Long-term effects of yoga therapy on cancer patients should be the subject of further research.",2019,"Six months after the end of yoga therapy, symptoms of anxiety, depression, and fatigue were significantly reduced compared with baseline.","['Cancer Patients 6 Months', '58 patients participated in the study', 'cancer patients', 'cancer patients with mixed diagnoses to evaluate long-term changes of symptoms of anxiety, depression, and fatigue 6 months after the end of yoga therapy', 'Cancer patients']","['Yoga therapy', 'yoga therapy']","['anxiety symptoms with the Generalized Anxiety Disorder scale (GAD-7), depressive symptoms with the Patient Health Questionnaire-2 (PHQ-2), and fatigue with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Fatigue Scale (EORTC QLQ-FA13', 'symptoms of anxiety and fatigue slightly', 'symptoms of anxiety, depression, and fatigue', 'anxiety, depression, and fatigue in cancer', 'Symptoms of Anxiety, Depression, and Fatigue']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",58.0,0.0358128,"Six months after the end of yoga therapy, symptoms of anxiety, depression, and fatigue were significantly reduced compared with baseline.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lundt', 'Affiliation': '1 University Medical Center, Comprehensive Cancer Center Mainfranken, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Jentschke', 'Affiliation': '1 University Medical Center, Comprehensive Cancer Center Mainfranken, University of Würzburg, Würzburg, Germany.'}]",Integrative cancer therapies,['10.1177/1534735418822096']
1035,32133931,Effects of incentivizing viral suppression in previously incarcerated adults living with HIV.,"Background: The amount of HIV in a person's blood can be suppressed to an undetectable level through antiretroviral therapy medications (ART). Adhering to an ART regimen can improve a person's health and reduce HIV transmission. Despite these benefits, many people with HIV do not maintain the level of adherence required to achieve an undetectable viral load. This problem is particularly common among people who have been incarcerated. Objective: To determine effects of incentivizing viral suppression in previously incarcerated adults with HIV. Methods: Adults with HIV (N = 102) and detectable viral load (>200 copies/mL) were randomly assigned to a Usual Care or Incentive group. Usual Care participants did not earn incentives for viral suppression. Incentive participants earned incentives ($10/day maximum) for providing blood samples with a reduced or undetectable (<200 copies/mL) viral load. Assessments were conducted every 3 months. Results collected during the first year were aggregated and compared based on group assignment and incarceration history. Results: Previously incarcerated participants in the Incentive group provided more (OR: 2.9; CI: 1.3-6.8; p <.05) blood samples with an undetectable viral load (69%) than those in the Usual Care group (41%). Never-incarcerated participants in the Incentive group provided more (OR: 6.8; CI: 2.2-21.0; p <.01) blood samples with an undetectable viral load (78%) than those in the Usual Care group (36%). Effects of incentives did not differ by incarceration history. Conclusions: Incentivizing viral suppression can increase viral suppression (undetectable viral load) in people who have been incarcerated.",2020,Never-incarcerated participants in the Incentive group provided more (OR: 6.8; CI: 2.2-21.0; p <.01) blood samples with an undetectable viral load (78%) than those in the Usual Care group (36%).,"['Adults with HIV (N\u2009=\u2009102) and detectable viral load (>200 copies/mL', 'previously incarcerated adults living with HIV', 'previously incarcerated adults with HIV', 'people who have been incarcerated']","['incentivizing viral suppression', 'Usual Care or Incentive group']","[""person's health and reduce HIV transmission"", 'viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",,0.147619,Never-incarcerated participants in the Incentive group provided more (OR: 6.8; CI: 2.2-21.0; p <.01) blood samples with an undetectable viral load (78%) than those in the Usual Care group (36%).,"[{'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pollock', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Rodewald', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fingerhood', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",HIV research & clinical practice,['10.1080/25787489.2020.1735816']
1036,32145206,Evaluation of Efficacy of Low Intensity Pulsed Ultrasound in Facilitating Mandibular Fracture Healing-A Blinded Randomized Controlled Clinical Trial.,"PURPOSE
The aim of the study was to evaluate the role of low intensity pulsed ultrasound (LIPUS) in improving fracture healing in American Society of Anesthesiologists Class II patients with mandibular fractures.
MATERIALS AND METHODS
A randomized controlled clinical trial of 40 patients with mandibular fractures was conducted. The patients were randomly allocated to the study and control groups, with 20 members each. A standardized surgical protocol was followed to manage the fractures by open reduction and internal fixation. After fixation, the study group received LIPUS stimulation (1.5 MHz, 30 mW/cm 2 ) on postoperative days 4, 8, 14, and 20 for 20 minutes daily; the control group received no LIPUS stimulation. The outcome parameters assessed were postoperative pain, wound healing, teeth mobility, and radiographic and ultrasound fracture healing.
RESULTS
The study variables were analyzed using the independent samples t test or Mann-Whitney U test. The pain score was reduced in the study group on all postoperative days (P < .001). The mean amount of wound healing was better in the study group than in the control group on days 5 and 9 (P < .004 and P < .019, respectively). The mean score for the ultrasound assessment of fracture healing was greater in the study group, with a statistically significant difference.
CONCLUSIONS
LIPUS application reduced postoperative pain and facilitated fracture healing in patients with compromised healing potential.",2020,The pain score was reduced in the study group on all postoperative days (P < .001).,"['American Society of Anesthesiologists Class II patients with mandibular fractures', '40 patients with mandibular fractures', 'patients with compromised healing potential']","['low intensity pulsed ultrasound (LIPUS', 'LIPUS stimulation', 'LIPUS application', 'Low Intensity Pulsed Ultrasound', 'control group received no LIPUS stimulation']","['postoperative pain and facilitated fracture healing', 'mean amount of wound healing', 'pain score', 'postoperative pain, wound healing, teeth mobility, and radiographic and ultrasound fracture healing', 'mean score for the ultrasound assessment of fracture healing']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024692', 'cui_str': 'Mandibular Fractures'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C4042796', 'cui_str': 'Low Intensity Pulsed Ultrasound'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0040445', 'cui_str': 'Tooth Mobility'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",40.0,0.0370075,The pain score was reduced in the study group on all postoperative days (P < .001).,"[{'ForeName': 'Aswath', 'Initials': 'A', 'LastName': 'Gopalan', 'Affiliation': 'Postgraduate Trainee, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}, {'ForeName': 'Elavenil', 'Initials': 'E', 'LastName': 'Panneerselvam', 'Affiliation': 'Reader, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India. Electronic address: elavenilomfs@gmail.com.'}, {'ForeName': 'Guruprasad Thulasi', 'Initials': 'GT', 'LastName': 'Doss', 'Affiliation': 'Reader, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}, {'ForeName': 'Keerthana', 'Initials': 'K', 'LastName': 'Ponvel', 'Affiliation': 'Postgraduate Trainee, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}, {'ForeName': 'Krishnakumar', 'Initials': 'K', 'LastName': 'Raja Vb', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.036']
1037,32208397,Safety and Efficacy of Prasugrel in Elderly/Low Body Weight Japanese Patients with Ischemic Stroke: Randomized PRASTRO-II.,"INTRODUCTION
The safety of prasugrel in elderly and/or low body weight Japanese patients with ischemic stroke who have a relatively high bleeding risk with antiplatelet therapy remains unknown.
OBJECTIVE
We aimed to investigate the safety and efficacy of long-term prasugrel monotherapy for stroke prevention compared with clopidogrel in elderly and/or low body weight Japanese patients with non-cardioembolic ischemic stroke.
METHODS
In this randomized, double-blind, comparative, phase III study, elderly (age ≥75 years) and/or low body weight (≤50 kg) Japanese patients with a previous history of non-cardioembolic ischemic stroke were assigned to a prasugrel 3.75 mg (PRA3.75) group, a prasugrel 2.5 mg (PRA2.5) group, or a clopidogrel 50 mg (CLO50) group and followed up for 48 weeks. The primary safety endpoint was the combined incidence of primary safety events, defined as life-threatening, major, and other clinically relevant bleeding. The efficacy endpoint was a composite of ischemic stroke, myocardial infarction, and death from other vascular causes.
RESULTS
A total of 654 patients (age 76.4 ± 7.3 years, body weight 55.6 ± 9.3 kg, women 43.9%) from 74 medical institutions within Japan were enrolled. The combined incidence (95% CI) of primary safety events was 4.2% (1.9-7.8%), 1.9% (0.5-4.7%), and 3.6% (1.6-6.9%) in the PRA3.75 group (n = 216), PRA2.5 group (n = 215), and CLO50 group (n = 223), respectively (hazard ratios [HR] PRA3.75/CLO50, 1.13 [0.44-2.93]; PRA2.5/CLO50, 0.51 [0.15-1.69]). The incidences of bleeding leading to treatment discontinuation (95% CI) were 2.3% (0.8-5.3%), 0.9% (0.1-3.3%), and 2.2% (0.7-5.2%) in the PRA3.75, PRA2.5, and CLO50 groups, respectively (HRs PRA3.75/CLO50, 1.01 [0.29-3.48]; PRA2.5/CLO50, 0.41 [0.08-2.12]). There was no significant difference in all bleeding events between groups. The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
CONCLUSIONS
Elderly and/or low body weight -Japanese patients with previous non-cardioembolic ischemic stroke who received PRA3.75 showed similar results in terms of primary safety endpoint, and a numerically lower incidence of ischemic stroke, myocardial infarction, and death from other vascular causes, compared with those who received CLO50.",2020,"The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
","['Elderly/Low Body Weight Japanese Patients with Ischemic Stroke', '654 patients (age 76.4 ± 7.3 years, body weight 55.6 ± 9.3 kg, women 43.9%) from 74 medical institutions within Japan were enrolled', 'elderly and/or low body weight Japanese patients with non-cardioembolic ischemic stroke', 'elderly and/or low body weight Japanese patients with ischemic stroke who have a relatively high bleeding risk with antiplatelet therapy remains unknown', 'elderly (age ≥75 years) and/or low body weight (≤50 kg) Japanese patients with a previous history of non-cardioembolic ischemic stroke']","['clopidogrel', 'Prasugrel', 'prasugrel 3.75 mg (PRA3.75', 'clopidogrel 50 mg (CLO50', 'PRA3.75', 'prasugrel 2.5\xa0mg (PRA2.5', 'long-term prasugrel monotherapy', 'prasugrel']","['combined incidence of primary safety events, defined as life-threatening, major, and other clinically relevant bleeding', 'Safety and Efficacy', 'composite of ischemic stroke, myocardial infarction, and death from other vascular causes', 'bleeding events', 'incidences of bleeding leading to treatment discontinuation', 'incidence of ischemic stroke, myocardial infarction, and death from other vascular causes', 'ischemic stroke, myocardial infarction, and death', 'safety and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",654.0,0.052672,"The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
","[{'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan, kitagawa.kazuo@twmu.ac.jp.""}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Nishikawa', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Mie, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nanto', 'Affiliation': 'Department of Cardiology, Nishinomiya Municipal Central Hospital, Hyogo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Waseda University Faculty of Science and Engineering, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ogawa', 'Affiliation': 'Department of Neurosurgery, Iwate Medical University, Iwate, Japan.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506825']
1038,31315908,"Oral levosimendan in amyotrophic lateral sclerosis: a phase II multicentre, randomised, double-blind, placebo-controlled trial.","OBJECTIVE
To evaluate the efficacy and safety of oral levosimendan in patients with amyotrophic lateral sclerosis (ALS). This phase II, randomised, double-blind, placebo-controlled, crossover, three-period study with 6 months open-label follow-up enrolled adults with ALS and sitting slow vital capacity (SVC) 60%-90 % of predicted from 11 sites in four countries.
METHODS
Patients received levosimendan 1 mg daily, 1 mg two times a day or placebo during three 14-day crossover periods and levosimendan 1-2 mg daily during open-label follow-up. Primary endpoint was sitting SVC; secondary endpoints included supine SVC, ALS Functional Rating Scale-Revised (ALSFRS-R), tolerability and safety.
RESULTS
Of 66 patients randomised, 59 contributed to the double-blind results and 50 entered open-label follow-up. Sitting SVC was not significantly different between the treatments. In post hoc analysis using period-wise baselines, supine SVC favoured levosimendan over placebo, estimated mean differences from baseline being -3.62% on placebo, +0.77% on levosimendan 1 mg daily (p=0.018) and +2.38% on 1 mg two times a day (p=0.001). Headache occurred in 16.7% of patients during levosimendan 1 mg daily (p=0.030), 28.6% during 1 mg two times a day (p=0.002) and 3.3% during placebo. The respective frequencies for increased heart rate were 5.1% (p=0.337), 18.5% (p=0.018) and 1.7%. No significant differences between the treatments were seen for other adverse events.
CONCLUSIONS
Levosimendan did not achieve the primary endpoint of improving sitting SVC in ALS. Headache and increased heart rate were increased on levosimendan, although it was otherwise well tolerated. A phase III study to evaluate the longer term effects of oral levosimendan in ALS is ongoing.",2019,"Headache occurred in 16.7% of patients during levosimendan 1 mg daily (p=0.030), 28.6% during 1 mg two times a day (p=0.002) and 3.3% during placebo.","['up enrolled adults with ALS and sitting slow vital capacity (SVC) 60%-90 % of predicted from 11 sites in four countries', 'amyotrophic lateral sclerosis', '66 patients randomised', 'patients with amyotrophic lateral sclerosis (ALS']","['oral levosimendan', 'Oral levosimendan', '6 months open-label follow', 'levosimendan', 'placebo', 'Levosimendan', 'levosimendan 1\u2009mg daily, 1\u2009mg two times a day or placebo']","['Sitting SVC', 'tolerated', 'Headache', 'heart rate', 'efficacy and safety', 'Headache and increased heart rate', 'sitting SVC; secondary endpoints included supine SVC, ALS Functional Rating Scale-Revised (ALSFRS-R), tolerability and safety', 'sitting SVC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity (observable entity)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}]",59.0,0.557233,"Headache occurred in 16.7% of patients during levosimendan 1 mg daily (p=0.030), 28.6% during 1 mg two times a day (p=0.002) and 3.3% during placebo.","[{'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Al-Chalabi', 'Affiliation': ""Department of Basic and Clinical Neuroscience, King's College London, Maurice Wohl Clinical Neuroscience Institute, London, UK.""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Shaw', 'Affiliation': 'Sheffield Institute for Translational Neuroscience and NIHR Sheffield Biomedical Research Centre, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'P Nigel', 'Initials': 'PN', 'LastName': 'Leigh', 'Affiliation': 'Department of Neuroscience Brighton and Sussex Medical School, Trafford Centre for Biomedical Science, Falmer, Brighton, UK.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'van den Berg', 'Affiliation': 'Departmentof Neurology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Hardiman', 'Affiliation': 'Academic Unit of Neurology, Trinity Biomedical Sciences Institute, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Ludolph', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Valtteri V', 'Initials': 'VV', 'LastName': 'Aho', 'Affiliation': 'Orion Pharma, Orion Corporation, Turku, Finland valtteri.aho@orionpharma.com.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Sarapohja', 'Affiliation': 'Orion Pharma, Orion Corporation, Espoo, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kuoppamäki', 'Affiliation': 'Orion Pharma, Orion Corporation, Turku, Finland.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2018-320288']
1039,31315799,Superficial Surgical Site Infection Following the Use of Intracutaneous Sutures Versus Staples.,"BACKGROUND
Superficial wound infections after gastrointestinal surgery markedly impair the affected patients' quality of life. As it is still unknown which method of skin closure is best for the reduction of wound infections in elective gastrointestinal sur- gery, we compared the frequency of wound infections after intracutaneous suturing versus skin stapling.
METHODS
In a prospective, randomized, single-center study, patients undergoing elective gastrointestinal surgery were intraoperatively randomized to skin closure either with an intracutaneous suture or with staples. The primary endpoint-the occurrence of a grade A1 wound infection within 30 days of surgery-was evaluated according to the intention-to-treat principle.
RESULTS
Out of a total of 280 patients, 141 were randomized to intracutaneous suturing and 139 to stapling. The groups did not differ significantly with respect to age, sex, or ASA classification. 19 of the 141 patients in the intracutaneous suturing group (13.5%) had a grade A1 wound infection, compared with 23 of 139 in the stapling group (16.6%) (odds ratio [OR]: 0.79; 95% confidence interval: [0.41; 1.52]; p = 0.47). A multiple regression analysis revealed that the type of surgery (colorectal vs. other), the approach, and the incision length were independent risk factors for a grade A1 wound infection. When wound dehiscences were additionally considered, wound complications were found to have arisen significantly more often in the stapling group than in the intracutaneous suturing group (16.3% [23/141] versus 30.2% [42/139], OR: 0.45 [0.25; 0.80]; p = 0.006).
CONCLUSION
In elective gastrointestinal surgery, intracutaneous suturing was not found to be associated with a lower rate of superficial wound infections than skin stapling, but fewer wound dehiscences occurred in the intracutaneous suturing group.",2019,"In elective gastrointestinal surgery, intracutaneous suturing was not found to be associated with a lower rate of superficial wound infections than skin stapling, but fewer wound dehiscences occurred in the intracutaneous suturing group.","['patients undergoing elective gastrointestinal surgery', '280 patients, 141 were randomized to']","['Intracutaneous Sutures Versus Staples', 'intracutaneous suturing and 139 to stapling', 'intracutaneous suturing', 'intracutaneous suturing versus skin stapling', 'skin closure either with an intracutaneous suture or with staples']","['wound complications', 'wound dehiscences', 'Superficial Surgical Site Infection', 'occurrence of a grade A1 wound infection', 'grade A1 wound infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C1096106'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence (morphologic abnormality)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}]",280.0,0.0479287,"In elective gastrointestinal surgery, intracutaneous suturing was not found to be associated with a lower rate of superficial wound infections than skin stapling, but fewer wound dehiscences occurred in the intracutaneous suturing group.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Maurer', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery Universität Gießen und Marburg GmbH, Marburg; Clinica Trials Coordination Center (KKS), Philipps-Universität Marburg, Marburg.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reuss', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Maschuw', 'Affiliation': ''}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Aminossadati', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neubert', 'Affiliation': ''}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': ''}, {'ForeName': 'Detlef K', 'Initials': 'DK', 'LastName': 'Bartsch', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0365']
1040,32492080,Effect of Aspirin vs Placebo on the Prevention of Depression in Older People: A Randomized Clinical Trial.,"Importance
Depression is associated with increased inflammation, which may precede its onset, especially in older people. Some preclinical data suggest potential antidepressant effects of aspirin, supported by limited observational data suggesting lower rates of depression in individuals treated with aspirin. There currently appears to be no evidence-based pharmacotherapies for the primary prevention of depression.
Objective
To determine whether low-dose aspirin (100 mg) reduces the risk of depression in healthy older adults.
Design, Setting, and Participants
This double-blinded, placebo-controlled randomized clinical trial was a substudy of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which examined if aspirin increased healthy life span, defined as survival free of dementia and disability. The prespecified secondary outcome was depression. Individuals of all races/ethnicities older than 70 years in Australia, as well as white individuals older than 70 years and black and Hispanic individuals older than 65 years in the United States, were included.
Interventions
Participants were randomized to aspirin (100 mg daily) or placebo, with a median (interquartile range) follow-up of 4.7 (3.5-5.6) years.
Main Outcomes and Measures
The primary outcome was a proxy measure of major depressive disorder defined as a score of 8 or more on the Center for Epidemiologic Studies Depression 10-item (CES-D-10) scale.
Results
Of the 19 114 participants enrolled in the trial, 9525 received aspirin and 9589 received a placebo. The mean (SD) age was 75.2 (4.0) years in the aspirin group and 75.1 (4.5) years in the placebo group; 9531 (56.4%) were women. Participants' demographics and clinical characteristics at baseline were similar between groups. A total of 79 886 annual CES-D-10 measurements were taken, with a mean of 4.2 measurements per participant. There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups. The incidence rate of new CES-D-10 scores of 8 or more was 70.4 events per 1000 person-years in the aspirin group and 69.1 in the placebo group (hazard ratio, 1.02 [95% CI, 0.96-1.08]; P = .54).
Conclusions and Relevance
Low-dose aspirin did not prevent depression in this large-scale study of otherwise healthy older adults.
Trial Registration
ClinicalTrials.gov Identifier: NCT01038583.",2020,There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups.,"['The mean (SD) age was 75.2\u2009(4.0) years in the aspirin group and 75.1\u2009(4.5) years in the placebo group; 9531 (56.4%) were women', 'otherwise healthy older adults', 'Individuals of all races/ethnicities older than 70 years in Australia, as well as white individuals older than 70 years and black and Hispanic individuals older than 65 years in the United States, were included', '19\u202f114 participants enrolled in the trial, 9525 received', 'healthy older adults', 'Older People']","['Aspirin vs Placebo', 'Aspirin', 'aspirin', 'low-dose aspirin', 'placebo']","['risk of depression', 'healthy life span', 'survival free of dementia and disability', 'depression', 'proxy measure of major depressive disorder defined as a score of 8 or more on the Center for Epidemiologic Studies Depression 10-item', 'incidence rate of new CES-D-10\u2009scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0559741', 'cui_str': 'Item score'}]",19114.0,0.692445,There were no significant differences at annual visits in the proportions of CES-D-10 scores of 8 or more between the aspirin and placebo groups.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Rush Alzheimer's Disease Center, Department of Family Medicine, Rush University Medical Center, Chicago, Illinois.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Fitzgerald', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stocks', 'Affiliation': 'Discipline of General Practice, Adelaide Medical School, University of Adelaide, Australia.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, the Epworth Clinic, Epworth Healthcare, Camberwell, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Agustini', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation Strategy Research Centre, Deakin University School of Medicine, Geelong, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1214']
1041,31301748,"Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis.","BACKGROUND
People severely impaired with progressive multiple sclerosis spend much of their day sitting, with very few options to improve motor function. As a result, secondary physical and psychosocial complications can occur. Effective and feasible self-management strategies are needed to reduce sedentary behaviour and enhance motor function. In this study, we aimed to assess the clinical and cost effectiveness of a home-based, self-managed, standing frame programme.
METHODS
SUMS was a pragmatic, multicentre, randomised controlled superiority trial of people with progressive multiple sclerosis and severe mobility impairment, undertaken in eight centres from two regions in the UK. The study had assessor-blinded outcome assessments with use of clinician-rated and patient-rated measures at baseline, 20 weeks, and 36 weeks. After baseline assessment, participants were randomised (1:1) by computer-generated assignment to either a standing frame programme plus usual care or usual care alone. The intervention consisted of two home-based physiotherapy sessions (60 min each) to set up the standing frame programme, supported by six follow-up telephone calls (15 min per call). Participants were asked to stand for 30 min, three times per week over 20 weeks, and encouraged to continue in the longer term, although no further physiotherapy support was provided. The primary clinical outcome was motor function measured by the Amended Motor Club Assessment (AMCA) score at week 36, analysed in the modified intention-to-treat population (excluding only patients who were deemed ineligible after randomisation, those who withdrew from the trial and were unwilling for their previously collected data to be used, or those who did not provide baseline and week 36 measurements). A 9-point AMCA score change was considered clinically meaningful a priori. Adverse events were collected through a daily preformatted patient diary throughout the 36 weeks and analysed in the modified intention-to-treat population. An economic assessment established the resources required to provide the standing frame programme, estimated intervention costs, and estimate cost effectiveness. This trial is registered with the International Standard Randomised Controlled Trials, number ISRCTN69614598.
FINDINGS
Between Sept 16, 2015, and April 28, 2017, 285 people with progressive multiple sclerosis were screened for eligibility, and 140 were randomly assigned to either the standing frame group (n=71) or the usual care group (n=69). Of these, 122 completed the primary outcome assessment (61 participants in both groups) for the modified intention-to-treat analysis. The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9-7·5; p=0·0014). For adverse events collected through patient diaries, we observed a disparity between the two groups in the frequency of short-term musculoskeletal pain (486 [41%] of 1188 adverse events in the standing frame group vs 160 [22%] of 736 adverse events in the usual care group), which was potentially related to the intervention. The musculoskeletal pain lasted longer than 7 days in five participants (two in the standing frame group and three in the usual care group). No serious adverse events related to the study occurred. The standing frame group had a mean 0·018 (95% CI -0·014 to 0·051) additional quality-adjusted life-years (QALYs) compared with those of the usual care group, and the estimated incremental cost-per-QALY was approximately £14 700.
INTERPRETATION
The standing frame programme significantly increased motor function in people with severe progressive multiple sclerosis, although not to the degree that was considered a priori as clinically meaningful. The standing frame is one of the first physiotherapy interventions to be effective in this population. We suggest that the programme is feasible as a home-based, self-managed intervention that could be routinely implemented in clinical practice in the UK.
FUNDING
UK National Institute of Health Research.",2019,"The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9-7·5; p=0·0014).","['285 people with progressive multiple sclerosis', 'Between Sept 16, 2015, and April 28, 2017', 'people with severe progressive multiple sclerosis', 'people with progressive multiple sclerosis (SUMS', 'people with progressive multiple sclerosis and severe mobility impairment, undertaken in eight centres from two regions in the UK']","['computer-generated assignment to either a standing frame programme plus usual care or usual care alone', 'home-based standing frame programme', 'usual care group', 'two home-based physiotherapy sessions (60 min each) to set up the standing frame programme, supported by six follow-up telephone calls']","['sedentary behaviour and enhance motor function', 'frequency of short-term musculoskeletal pain', 'musculoskeletal pain', 'AMCA score', 'Adverse events', 'motor function', 'motor function measured by the Amended Motor Club Assessment (AMCA) score']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",61.0,0.129963,"The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9-7·5; p=0·0014).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK. Electronic address: jenny.freeman@plymouth.ac.uk.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hendrie', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK; Norwich MS Centre, Norwich, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jarrett', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK; Mardon Neurorehabilitation Centre, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hawton', 'Affiliation': 'University of Exeter Medical School, Health Economics Group, University of Exeter, Exeter, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'NIHR Research Design Service, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dennett', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Medical Statistics Group, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zajicek', 'Affiliation': 'School of Medicine, Medical and Biological Sciences, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Medical Statistics Group, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK; Peninsula Clinical Trials Unit, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30190-5']
1042,31226660,Influence of subliminal intragastric fatty acid infusion on subjective and physiological responses to positive emotion induction in healthy women: A randomized trial.,"BACKGROUND
Subliminal intragastric fatty acid infusion attenuates subjective and brain responses to negative emotion induction. However, the underlying gut-brain signaling mechanisms remain unclear, and it is unknown whether such effect equally applies to positive emotion.
OBJECTIVE
We aimed to investigate the interaction between fatty acid-induced gut-brain signaling and subjective responses to positive emotion, and the potential mediational role of gastrointestinal (GI) hormones.
DESIGN
Twelve fasting healthy women underwent intragastric infusion of 2.5 g lauric acid or saline, after which either positive or neutral emotion was induced for 30 min, in 4 separate visits. Appetite-related sensations, subjective emotional state, and GI hormones were measured at baseline and every 10 min after infusion. Heart rate variability was measured at baseline and at t = 20-30 min to quantify vagal tone (root mean square of successive differences, RMSSD), and sympathovagal balance (low frequency to high frequency ratio, LF/HF).
RESULTS
Fatty acid infusion did not influence appetite-related sensations (as expected), nor emotional state ratings (contrary to expectations). As anticipated, fatty acid stimulated release of CCK at t = 20-40 min (p < 0.001), and GLP1 at t = 30-40 min (p < 0.001), but not PYY. Interestingly, positive emotion induction suppressed plasma octanoylated ghrelin at t = 20-40 min (p = 0.020). Further, both positive emotion and fatty acid attenuated RMSSD (p = 0.012 & 0.0073, respectively). Positive emotion attenuated LF/HF after fatty acid (p = 0.0006), but raised LF/HF after saline (p = 0.004).
CONCLUSIONS
Subliminal fatty acid did not influence subjective responses to positive emotion induction. However, positive emotion induction suppressed octanoylated ghrelin release. Moreover, both positive emotion and subliminal fatty acid decreased cardiac vagal tone. Further, the fatty acid reversed the effect of positive emotion on sympathovagal balance.",2019,"Positive emotion attenuated LF/HF after fatty acid (p = 0.0006), but raised LF/HF after saline (p = 0.004).
","['Twelve fasting healthy women underwent', 'healthy women']","['subliminal intragastric fatty acid infusion', 'intragastric infusion of 2.5\u202fg lauric acid or saline']","['subjective and physiological responses', 'appetite-related sensations', 'positive emotion induction suppressed plasma octanoylated ghrelin', 'Positive emotion attenuated LF/HF after fatty acid', 'Heart rate variability', 'Appetite-related sensations, subjective emotional state, and GI hormones', 'positive emotion and fatty acid attenuated RMSSD', 'emotional state ratings', 'positive emotion and subliminal fatty acid decreased cardiac vagal tone', 'sympathovagal balance']","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0023139', 'cui_str': 'lauric acid'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",12.0,0.114099,"Positive emotion attenuated LF/HF after fatty acid (p = 0.0006), but raised LF/HF after saline (p = 0.004).
","[{'ForeName': 'Dongxing', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Herestraat 49 B701, 3000, Leuven, Belgium; Institute for Diabetes Research and Metabolic Diseases (IDM) of the Helmholtz Center Munich at the University of Tübingen, Oetfried-Mueller-Strasse 47, 72076, Tuebingen, Germany.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Boey', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Herestraat 49 B701, 3000, Leuven, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Weltens', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Herestraat 49 B701, 3000, Leuven, Belgium.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Biesiekierski', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Iven', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Herestraat 49 B701, 3000, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Depoortere', 'Affiliation': 'Gut Peptide Research Lab, Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Herestraat 49 B701, 3000, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Gastrointestinal Sensitivity and Motility Research Group, Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Herestraat 49 B701, 3000, Leuven, Belgium.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Herestraat 49 B701, 3000, Leuven, Belgium. Electronic address: lukas.vanoudenhove@kuleuven.be.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.06.010']
1043,31297582,"Comparison of Topical, Systemic, and Combined Therapy with Steroids on Idiopathic Granulomatous Mastitis: A Prospective Randomized Study.","BACKGROUND
Idiopathic granulomatous mastitis (IGM) is a benign disorder of the breast, for which the optimal treatment modality remains missing.
METHODS
A total of 124 patients with a histopathologically proven diagnosis of IGM were enrolled in a prospective, randomized parallel arm study. Patients were treated with topical steroids in Group T (n: 42), systemic steroids (0.8 mg/kg/day peroral) in Group S (n: 42), and combined steroids (0.4 mg/kg/day peroral + topical) in Group C (n: 40). Compliance with the therapy, response to the therapy, the duration of therapy, side effects and the recurrence rates were compared.
RESULTS
Sixteen patients did not comply with the treatment, and the highest ratio of compliance with therapy was seen in Group T (p < 0.05). Complete clinical regression (CCR) was observed in 90 (83.3%) patients. Response to the treatment (RT) was evaluated radiologically and observed in 89.8% of the patients. There was no statistically significant difference between groups regarding CCR, RT and the recurrence rate. The longest duration of therapy was observed in Group T (22 ± 9.1-week), whereas the shortest was observed in Group S (11.7 ± 5.5-week) (p < 0.001). The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively) (p < 0.001).
CONCLUSIONS
The efficiency of the treatment was similar for all groups, both clinically and radiologically. Although the duration of therapy was longer in Group T, the lack of systemic side effects increased the compliance of the patients with the therapy. Therefore, topical steroids would be among first-line treatment options of IGM.",2019,"The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively)","['Idiopathic Granulomatous Mastitis', '124 patients with a histopathologically proven diagnosis of IGM']","['combined steroids (0.4\xa0mg/kg/day peroral\u2009+\u2009topical', 'systemic steroids', 'topical steroids', 'Topical, Systemic, and Combined Therapy with Steroids']","['highest ratio of compliance with therapy', 'Complete clinical regression (CCR', 'longest duration of therapy', 'duration of therapy, side effects and the recurrence rates', 'systemic side effects', 'CCR, RT and the recurrence rate']","[{'cui': 'C4552494', 'cui_str': 'Idiopathic granulomatous mastitis'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0020861', 'cui_str': 'IgM'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]",124.0,0.0170221,"The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively)","[{'ForeName': 'Kenan', 'Initials': 'K', 'LastName': 'Çetin', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey. drkenancetin@hotmail.com.'}, {'ForeName': 'Hasan E', 'Initials': 'HE', 'LastName': 'Sıkar', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nuri E', 'Initials': 'NE', 'LastName': 'Göret', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Günay', 'Initials': 'G', 'LastName': 'Rona', 'Affiliation': 'Department of Radiology, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nagehan Ö', 'Initials': 'NÖ', 'LastName': 'Barışık', 'Affiliation': 'Department of Pathology, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hasan F', 'Initials': 'HF', 'LastName': 'Küçük', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Bahadır M', 'Initials': 'BM', 'LastName': 'Gulluoglu', 'Affiliation': 'Breast and Endocrine Surgery Unit, Department of General Surgery, Marmara University School of Medicine, 34899, Pendik, Istanbul, Turkey.'}]",World journal of surgery,['10.1007/s00268-019-05084-x']
1044,31290981,Glucocorticoid Replacement Affects Serum Adiponectin Levels and HDL-C in Patients With Secondary Adrenal Insufficiency.,"CONTEXT
Low serum adiponectin and high-density lipoprotein-cholesterol (HDL-C) levels are risk factors for cardiovascular disease. Patients with primary adrenal insufficiency are at higher risk of cardiovascular complications compared with healthy subjects. However, there is no information on the relationship between adiponectin and glucocorticoid replacement therapy in patients with secondary adrenal insufficiency (SAI).
OBJECTIVE
To determine the effects of intrinsic adrenal function and glucocorticoid replacement therapy on serum adiponectin levels and lipid profile in patients with SAI.
DESIGN
Part 1: a cross-sectional study. Part 2: a randomized, double-blind, crossover study.
SETTING
Osaka University Hospital, Osaka, Japan.
PATIENTS
Part 1: 58 patients diagnosed with nonfunctioning pituitary adenoma who underwent insulin tolerance test (ITT) for assessment of adrenal function. Part 2: 12 SAI patients randomly received hydrocortisone replacement therapy at a dose of 10, 20, or 30 mg/d for 4 weeks per term for three terms.
OUTCOME MEASUREMENTS
Part 1: we analyzed the relationship between serum cortisol levels during ITT and serum adiponectin levels and the lipid profile. Part 2: serum adiponectin levels and lipid profile were measured every 4 weeks.
RESULTS
Serum levels of adiponectin and HDL-C correlated significantly with peak cortisol levels after ITT. Serum adiponectin and HDL-C levels were significantly lower in patients with SAI than non-SAI. Serum levels of adiponectin and HDL-C increased in a hydrocortisone dose-dependent manner.
CONCLUSIONS
Glucocorticoid replacement therapy increased serum levels of adiponectin, an adipose-derived anti-atherogenic factor, and HDL-C in patients with SAI.",2019,Serum adiponectin and HDL-C levels were significantly lower in patients with SAI than non-SAI.,"['patients with secondary adrenal insufficiency (SAI', 'Part 1: 58 patients diagnosed with non-functioning pituitary adenoma who underwent insulin tolerance test (ITT) for assessment of adrenal function', 'patients with SAI', 'patients with secondary adrenal insufficiency', 'Patients with primary adrenal insufficiency', 'Osaka University Hospital, Osaka, Japan']","['Glucocorticoid replacement therapy', 'Glucocorticoid replacement', 'hydrocortisone replacement therapy', 'glucocorticoid replacement therapy']","['cardiovascular complications', 'Serum levels of adiponectin and HDL-C', 'serum levels of adiponectin, an adipose-derived anti-atherogenic factor, and HDL-C', 'serum cortisol levels during ITT and serum adiponectin levels and lipid profile', 'Serum adiponectin and HDL-C levels', 'peak cortisol levels', 'serum adiponectin levels and HDL-C', 'serum adiponectin levels and lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271738', 'cui_str': 'Secondary adrenocortical insufficiency'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032000', 'cui_str': 'Pituitary Adenoma'}, {'cui': 'C0236287', 'cui_str': 'Insulin tolerance test (procedure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001403', 'cui_str': 'Hypoadrenalisms, Primary'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",,0.0362271,Serum adiponectin and HDL-C levels were significantly lower in patients with SAI than non-SAI.,"[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Hayashi', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Tamada', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tetsuhiro', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Maeda', 'Affiliation': 'Department of Metabolism and Atherosclerosis, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Otsuki', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00420']
1045,31298350,Observation of curative effect of recombinant human basic fibroblast growth factor combined with compound polymyxin B ointment and local application of insulin on wound healing of deep second-degree burn in diabetes mellitus: a randomized study.,"OBJECTIVE
We aimed at investigating the clinical efficacy of recombinant human basic fibroblast growth factor combined with compound polymyxin B ointment and the local application of insulin on wound healing of deep second-degree burn in diabetes mellitus.
PATIENTS AND METHODS
80 diabetes mellitus patients complicated with deep second-degree burn treated from 2016 to December 2017 were selected and divided into observation group (n=40) and control group (n=40) using the random number method. Patients in control group were treated with compound polymyxin B ointment, while those in observation group were treated with basic fibroblast growth factor based on the treatment in control group. The time of wound pain relief, wound scarring, and wound healing was compared.
RESULTS
The number of positive bacteria in the wound was recorded and the duration of infection was also recorded. Moreover, the changes in the expressions of Advanced Glycation End products (AGEs) and Vascular Endothelial Growth Factor (VEGF) were analyzed. In observation group, the time of wound pain relief, wound scarring, and wound healing was significantly shorter than that in control group (p<0.05). At 3, 14, and 28 days after the treatment, the levels of AGEs in observation group were lower than those in control group, while the levels of VEGF in the observation group were higher than those in control group (p<0.05). The proportions of wound infection, skin necrosis, systemic blood infection, hypoglycemia, and hyperglycemia and the ineffective rate in observation group were significantly lower than that in control group (p<0.05).
CONCLUSIONS
The application of compound polymyxin B ointment and the local application of insulin combined with recombinant human basic fibroblast growth factor in diabetes mellitus patients complicated with a deep second-degree burn can effectively alleviate the pain, reduce the wound infection rate, promote the wound healing, and improve the overall therapeutic effect.",2019,"In observation group, the time of wound pain relief, wound scarring, and wound healing was significantly shorter than that in control group (p<0.05).","['wound healing of deep second-degree burn in diabetes mellitus', 'diabetes mellitus patients', 'deep second-degree burn in diabetes mellitus', '80 diabetes mellitus patients complicated with deep second-degree burn treated from 2016 to December 2017 were selected and divided into observation group (n=40) and control group (n=40) using the random number method']","['insulin combined with recombinant human basic fibroblast growth factor', 'compound polymyxin B ointment', 'recombinant human basic fibroblast growth factor combined with compound polymyxin B ointment and local application of insulin', 'recombinant human basic fibroblast growth factor combined with compound polymyxin B ointment', 'polymyxin B ointment', 'basic fibroblast growth factor']","['expressions of Advanced Glycation End products (AGEs) and Vascular Endothelial Growth Factor (VEGF', 'time of wound pain relief, wound scarring, and wound healing', 'number of positive bacteria', 'levels of AGEs', 'levels of VEGF', 'proportions of wound infection, skin necrosis, systemic blood infection, hypoglycemia, and hyperglycemia and the ineffective rate', 'duration of infection']","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0332687', 'cui_str': 'Second degree burn injury (morphologic abnormality)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0391444', 'cui_str': 'KCB-1 protein, recombinant'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation Endproducts'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0241745', 'cui_str': 'Wound pain (finding)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0564446', 'cui_str': 'Wound scar (disorder)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0151799', 'cui_str': 'Skin necrosis (disorder)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",80.0,0.0189191,"In observation group, the time of wound pain relief, wound scarring, and wound healing was significantly shorter than that in control group (p<0.05).","[{'ForeName': 'J-B', 'Initials': 'JB', 'LastName': 'Zhang', 'Affiliation': 'Department of Burn and Plastic Surgery, Cangzhou Central Hospital, Hebei, China. xueh92@126.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Wang', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201907_18345']
1046,30195831,"Comprehensive effects of left ventricular assist device speed changes on alveolar gas exchange, sleep ventilatory pattern, and exercise performance.","BACKGROUND
Increasing left ventricular assist device (LVAD) pump speed according to the patient's activity is a fascinating hypothesis. This study analyzed the short-term effects of LVAD speed increase on cardiopulmonary exercise test (CPET) performance, muscle oxygenation (near-infrared spectroscopy), diffusion capacity of the lung for carbon monoxide (Dlco) and nitric oxide (Dlno), and sleep quality.
METHODS
We analyzed CPET, Dlco and Dlno, and sleep in 33 patients supported with the Jarvik 2000 (Jarvik Heart Inc., New York, NY). After a maximal CPET (n = 28), patients underwent 2 maximal CPETs with LVAD speed randomly set at 3 or increased from 3 to 5 during effort (n = 15). Then, at LVAD speed randomly set at 2 or 4, we performed (1) constant workload CPETs assessing O 2 kinetics, cardiac output (CO), and muscle oxygenation (n = 15); (2) resting Dlco and Dlno (n = 18); and (3) nocturnal cardiorespiratory monitoring (n = 29).
RESULTS
The progressive pump speed increase raised peak volume of oxygen consumption (12.5 ± 2.5 ml/min/kg vs 11.7 ± 2.8 ml/min/kg at speed 3; p = 0.001). During constant workload, from speed 2 to 4, CO increased (at rest: 3.18 ± 0.76 liters/min vs 3.69 ± 0.75 liters/min, p = 0.015; during exercise: 5.91 ± 1.31 liters/min vs 6.69 ± 0.99 liters/min, p = 0.014), and system efficiency (τ = 65.8 ± 15.1 seconds vs 49.9 ± 14.8 seconds, p = 0.002) and muscle oxygenation improved. At speed 4, Dlco decreased, and obstructive apneas increased despite a significant apnea/hypopnea index and a reduction of central apneas.
CONCLUSIONS
Short-term LVAD speed increase improves exercise performance, CO, O 2 kinetics, and muscle oxygenation. However, it deteriorates lung diffusion and increases obstructive apneas, likely due to an increase of intrathoracic fluids. Self-adjusting LVAD speed is a fascinating but possibly unsafe option, probably requiring a monitoring of intrathoracic fluids.",2018,"During constant workload, from speed 2 to 4, CO increased (at rest: 3.18 ± 0.76 liters/min vs 3.69 ± 0.75 liters/min, p = 0.015; during exercise: 5.91 ± 1.31 liters/min vs 6.69 ± 0.99 liters/min, p = 0.014), and system efficiency (τ = 65.8 ± 15.1 seconds vs 49.9 ± 14.8 seconds, p = 0.002) and muscle oxygenation improved.","['33 patients supported with the Jarvik 2000 (Jarvik Heart Inc., New York, NY']","['LVAD', 'maximal CPET', 'constant workload CPETs assessing O 2 kinetics, cardiac output (CO), and muscle oxygenation (n\u202f=\u202f15); (2) resting Dlco and Dlno (n\u202f=\u202f18); and (3) nocturnal cardiorespiratory monitoring']","['exercise performance, CO, O 2 kinetics, and muscle oxygenation', 'system efficiency', 'alveolar gas exchange, sleep ventilatory pattern, and exercise performance', 'obstructive apneas', 'muscle oxygenation', 'peak volume of oxygen consumption', 'apnea/hypopnea index and a reduction of central apneas', 'cardiopulmonary exercise test (CPET) performance, muscle oxygenation (near-infrared spectroscopy), diffusion capacity of the lung for carbon monoxide (Dlco) and nitric oxide (Dlno), and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0027976', 'cui_str': 'New York'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C3544157', 'cui_str': 'Cardiorespiratory monitoring'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0520680', 'cui_str': 'Ondine Syndrome'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1532326', 'cui_str': 'Infrared'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",33.0,0.0389909,"During constant workload, from speed 2 to 4, CO increased (at rest: 3.18 ± 0.76 liters/min vs 3.69 ± 0.75 liters/min, p = 0.015; during exercise: 5.91 ± 1.31 liters/min vs 6.69 ± 0.99 liters/min, p = 0.014), and system efficiency (τ = 65.8 ± 15.1 seconds vs 49.9 ± 14.8 seconds, p = 0.002) and muscle oxygenation improved.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Apostolo', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Paolillo', 'Affiliation': 'Istituto di Ricerca Diagnostica e Nucleare, Istituto di Ricovero e Cura a Carattere Scientifico, Naples, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Contini', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Vignati', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy; Cardiovascular Section Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Tarzia', 'Affiliation': 'Cardiac Surgery Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Jeness', 'Initials': 'J', 'LastName': 'Campodonico', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Mapelli', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Massetti', 'Affiliation': 'Catholic University, Department of Cardiovascular Sciences, Gemelli Hospital, Rome, Italy.'}, {'ForeName': 'Jonida', 'Initials': 'J', 'LastName': 'Bejko', 'Affiliation': 'Cardiac Surgery Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Righini', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Tomaso', 'Initials': 'T', 'LastName': 'Bottio', 'Affiliation': 'Cardiac Surgery Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Bonini', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Salvioni', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gugliandolo', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'Department of Cardiovascular, Neural and Metabolic Sciences, San Luca Hospital, Istituto Auxologico Italiano, Milan, Italy; Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Lombardi', 'Affiliation': 'Department of Cardiovascular, Neural and Metabolic Sciences, San Luca Hospital, Istituto Auxologico Italiano, Milan, Italy.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Gerosa', 'Affiliation': 'Cardiac Surgery Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Salvi', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Alamanni', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Piergiuseppe', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': 'Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy; Cardiovascular Section Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy. Electronic address: piergiuseppe.agostoni@unimi.it.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2018.07.005']
1047,30595477,Exercise-Induced Changes in Visceral Adipose Tissue Mass Are Regulated by IL-6 Signaling: A Randomized Controlled Trial.,"Visceral adipose tissue is harmful to metabolic health. Exercise training reduces visceral adipose tissue mass, but the underlying mechanisms are not known. Interleukin-6 (IL-6) stimulates lipolysis and is released from skeletal muscle during exercise. We hypothesized that exercise-induced reductions in visceral adipose tissue mass are mediated by IL-6. In this randomized placebo-controlled trial, we assigned abdominally obese adults to tocilizumab (IL-6 receptor antibody) or placebo during a 12-week intervention with either bicycle exercise or no exercise. While exercise reduced visceral adipose tissue mass, this effect of exercise was abolished in the presence of IL-6 blockade. Changes in body weight and total adipose tissue mass showed similar tendencies, whereas lean body mass did not differ between groups. Also, IL-6 blockade increased cholesterol levels, an effect not reversed by exercise. Thus, IL-6 is required for exercise to reduce visceral adipose tissue mass and emphasizes a potentially important metabolic consequence of IL-6 blockade.",2019,"Changes in body weight and total adipose tissue mass showed similar tendencies, whereas lean body mass did not differ between groups.",['abdominally obese adults to'],"['tocilizumab (IL-6 receptor antibody) or placebo', 'bicycle exercise or no exercise', 'placebo', 'Exercise training']","['body weight and total adipose tissue', 'cholesterol levels', 'Interleukin-6 (IL-6) stimulates lipolysis', 'lean body mass', 'visceral adipose tissue mass']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0063717', 'cui_str': 'Receptors, IL-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.293131,"Changes in body weight and total adipose tissue mass showed similar tendencies, whereas lean body mass did not differ between groups.","[{'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Lang Lehrskov', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Christensen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Grit Elster', 'Initials': 'GE', 'LastName': 'Legaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dorph', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Monica Korsager', 'Initials': 'MK', 'LastName': 'Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Natja', 'Initials': 'N', 'LastName': 'Launbo', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Sabrina Ravn', 'Initials': 'SR', 'LastName': 'Fagerlind', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Sidsel Kofoed', 'Initials': 'SK', 'LastName': 'Seide', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Nymand', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ball', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Vinum', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Camilla Noerfelt', 'Initials': 'CN', 'LastName': 'Dahl', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Henneberg', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Janus Damm', 'Initials': 'JD', 'LastName': 'Nybing', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Bispebjerg, 2400 Copenhagen, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, 2000 Copenhagen, Denmark; Department of Rheumatology, Odense University Hospital, 5000 Odense, Denmark.'}, {'ForeName': 'Jaya Birgitte', 'Initials': 'JB', 'LastName': 'Rosenmeier', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Bispebjerg, Copenhagen, 2400 Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Bente Klarlund', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark. Electronic address: helga.ellingsgaard@regionh.dk.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, 2100 Copenhagen, Denmark.'}]",Cell metabolism,['10.1016/j.cmet.2018.12.007']
1048,31285653,The Role of Deconstructive Teaching in the Training of Laparoscopy.,"Background and Objectives
Skills-lab training is crucial for the development of advanced laparoscopic skills. In this study, we examined whether a systematic deconstructive and comprehensive tutoring approach improves training results in laparoscopic suturing and intracorporeal knot tying.
Methods
Sixteen residents in obstetrics and gynecology participating in structured skills-lab laparoscopy training were randomized in 2 equal-sized groups receiving 1-on-1 tutoring either in the traditional method or according to the Peyton's 4-step approach, involving an additional training step, with the trainees instructing the tutor to perform the exercises. A validated assessment tool (revised Objective Structured Assessment of Technical Skills) and the number of completed square knots per training session and the mean time per knot were used to assess the efficacy of training in both groups.
Results
Trainees in Peyton's group achieved significantly higher revised Objective Structured Assessment of Technical Skills scores (28.6 vs 23.9 points; P = .05) and were able to improve their scores during autonomous training repetitions, in contrast to the trainees not in Peyton's group (difference +4.75 vs -4.29 points, P = .02). Additionally, they seemed to be able to perform a greater number of successful knots during the exercise and to complete each knot quicker with the later observations failing to reach the threshold of statistical significance.
Conclusion
Peyton's 4-step approach seemed to be superior for teaching laparoscopic skills to obstetrics and gynecology residents in the skills-lab setting and can be therefore proposed for training curricula.",2019,"Trainees in Peyton's group achieved significantly higher revised Objective Structured Assessment of Technical Skills scores (28.6 vs 23.9 points; P = .05) and were able to improve their scores during autonomous training repetitions, in contrast to the trainees not in Peyton's group (difference +4.75 vs -4.29 points, P = .02).",['Sixteen residents in obstetrics and gynecology participating in structured skills-lab laparoscopy training'],"[""2 equal-sized groups receiving 1-on-1 tutoring either in the traditional method or according to the Peyton's 4-step approach, involving an additional training step, with the trainees instructing the tutor to perform the exercises"", 'laparoscopic suturing and intracorporeal knot tying']","['number of successful knots', 'revised Objective Structured Assessment of Technical Skills scores']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",16.0,0.0315935,"Trainees in Peyton's group achieved significantly higher revised Objective Structured Assessment of Technical Skills scores (28.6 vs 23.9 points; P = .05) and were able to improve their scores during autonomous training repetitions, in contrast to the trainees not in Peyton's group (difference +4.75 vs -4.29 points, P = .02).","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Balafoutas', 'Affiliation': 'University Hospital of Würzburg, Department of Obstetrics and Gynecology, Würzburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Joukhadar', 'Affiliation': 'University Hospital of Würzburg, Department of Obstetrics and Gynecology, Würzburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kiesel', 'Affiliation': 'University Hospital of Würzburg, Department of Obstetrics and Gynecology, Würzburg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Häusler', 'Affiliation': 'University Hospital of Würzburg, Department of Obstetrics and Gynecology, Würzburg, Germany.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Loeb', 'Affiliation': 'University Hospital of Würzburg, Department of Obstetrics and Gynecology, Würzburg, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Woeckel', 'Affiliation': 'University Hospital of Würzburg, Department of Obstetrics and Gynecology, Würzburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Herr', 'Affiliation': 'University Hospital of Würzburg, Department of Obstetrics and Gynecology, Würzburg, Germany.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2019.00020']
1049,31296588,"Effects of vitamin D supplementation on cognitive function and blood Aβ-related biomarkers in older adults with Alzheimer's disease: a randomised, double-blind, placebo-controlled trial.","OBJECTIVE
Our study aimed to assess the effect of a 12-month vitamin D supplementation on cognitive function and amyloid beta (Aβ)-related biomarkers in subjects with Alzheimer's disease (AD). METHODS : This was a randomised, double-blind, placebo-controlled trial. 210 AD patients were randomly divided into intervention and control groups. Participants received 12-month 800 IU/day of vitamin D or starch granules as placebo. Tests of cognitive performance and Aβ-related biomarkers were measured at baseline, 6 months and 12 months. RESULTS : Repeated-measures analysis of variance showed significant improvements in plasma Aβ42, APP, BACE1, APPmRNA, BACE1mRNA (p<0.001) levels and information, arithmetic, digit span, vocabulary, block design and picture arrange scores (p<0.05) in the intervention group over the control group. According to mixed-model analysis, vitamin D group had significant increase in full scale IQ during follow-up period (p<0.001).
CONCLUSIONS
Daily oral vitamin D supplementation (800 IU/day) for 12 months may improve cognitive function and decrease Aβ-related biomarkers in elderly patients with AD. Larger scale longer term randomised trials of vitamin D are needed.
TRIAL REGISTRATION NUMBER
ChiCTR-IIR-16009549.",2019,"Repeated-measures analysis of variance showed significant improvements in plasma Aβ42, APP, BACE1, APPmRNA, BACE1mRNA (p<0.001) levels and information, arithmetic, digit span, vocabulary, block design and picture arrange scores (p<0.05) in the intervention group over the control group.","[""older adults with Alzheimer's disease"", 'elderly patients with AD', '210 AD patients', ""subjects with Alzheimer's disease (AD""]","['vitamin D supplementation', 'vitamin D', 'placebo', 'vitamin D or starch granules as placebo']","['cognitive performance and Aβ-related biomarkers', 'full scale IQ', 'plasma Aβ42, APP, BACE1, APPmRNA, BACE1mRNA (p<0.001) levels and information, arithmetic, digit span, vocabulary, block design and picture arrange scores', 'cognitive function and blood Aβ-related biomarkers', 'cognitive function', 'cognitive function and amyloid beta ']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C3853573', 'cui_str': 'Granules'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0222045'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",,0.755744,"Repeated-measures analysis of variance showed significant improvements in plasma Aβ42, APP, BACE1, APPmRNA, BACE1mRNA (p<0.001) levels and information, arithmetic, digit span, vocabulary, block design and picture arrange scores (p<0.05) in the intervention group over the control group.","[{'ForeName': 'Jingya', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xiaoxu', 'Initials': 'X', 'LastName': 'Huo', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Rujuan', 'Initials': 'R', 'LastName': 'Miao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China mf2002245mf@aliyun.com.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2018-320199']
1050,31293236,Cultural adaptation of an existing children's weight management programme: the CHANGE intervention and feasibility RCT.,"BACKGROUND
Excess weight in children is a continuing health issue. Community-based children's weight management programmes have had some effect in promoting weight loss. Families from minority ethnic communities are less likely to complete these programmes but, to date, no programmes have been culturally adapted to address this.
OBJECTIVES
We aimed to (1) culturally adapt an existing weight management programme for children aged 4-11 years and their families to make it more suited to Pakistani and Bangladeshi communities but inclusive of all families and (2) evaluate the adapted programme to assess its feasibility and acceptability, as well as the feasibility of methods, for a future full-scale trial.
DESIGN
In phase I, a cultural adaptation of a programme that was informed by formative research and guided by two theoretical frameworks was undertaken and in phase II this adapted programme was delivered in a cluster-randomised feasibility study (for which the clusters were the standard and adapted children's weight management programmes).
SETTING
Birmingham: a large, ethnically diverse UK city.
PARTICIPANTS
In phase I, Pakistani and Bangladeshi parents of children with excess weight, and, in phase II, children aged 4-11 years who have excess weight and their families.
INTERVENTIONS
A culturally adapted children's weight management programme, comprising six sessions, which was delivered to children and parents, targeting diet and physical activity and incorporating behaviour change techniques, was developed in phase I and delivered in the intervention arm to 16 groups in phase II. The eight groups in the comparator arm received the standard (unadapted) children's weight management programme.
MAIN OUTCOME MEASURES
The primary outcome was the proportion of Pakistani and Bangladeshi families completing (attending ≥ 60% of) the adapted programme. Secondary outcomes included the proportion of all families completing the adapted programme, the feasibility of delivery of the programme, the programme's acceptability to participants, the feasibility of trial processes and the feasibility of collection of outcome and cost data.
RESULTS
The proportion of Pakistani and Bangladeshi families and all families completing the adapted programme was 78.8% [95% confidence interval (CI) 64.8% to 88.2%] and 76.3% (95% CI 67.0% to 83.6%), respectively. The programme was feasible to deliver with some refinements and was well received. Ninety-two families participated in outcome data collection. Data collection was mostly feasible, but participant burden was high. Data collection on the cost of programme delivery was feasible, but costs to families were more challenging to capture. There was high attrition over the 6-month follow-up period (35%) and differential attrition in the two study arms (29% and 52% in the intervention and comparator arms, respectively).
LIMITATIONS
The study was not designed to address the issue of low participant uptake of children's weight management programmes. The design of a future trial may include individual randomisation and a 'minimal intervention' arm, the acceptability of which has not been evaluated in this study.
CONCLUSIONS
The theoretically informed, culturally adapted children's weight management programme was highly acceptable to children and families of all ethnicities. Consideration should be given to a future trial to evaluate clinical effectiveness and cost-effectiveness of the adapted programme, but the design of a future trial would need to address the logistics of data collection, participant burden and study attrition.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN81798055.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 33. See the NIHR Journals Library website for further project information. Kate Jolly is part-funded by the Collaboration for Leadership in Applied Health Research and Care West Midlands.",2019,"The theoretically informed, culturally adapted children's weight management programme was highly acceptable to children and families of all ethnicities.","['children with excess weight, and, in phase II, children aged 4-11 years who have excess weight and their families', 'Birmingham: a large, ethnically diverse UK city', ""children's weight management programmes"", 'children aged 4-11 years and their families', 'Ninety-two families participated in outcome data collection']","[""standard (unadapted) children's weight management programme""]","['weight loss', 'proportion of Pakistani and Bangladeshi families completing', ""proportion of all families completing the adapted programme, the feasibility of delivery of the programme, the programme's acceptability to participants, the feasibility of trial processes and the feasibility of collection of outcome and cost data"", 'proportion of Pakistani and Bangladeshi families', 'differential attrition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0337814', 'cui_str': 'Pakistani (Urduspeakers) (ethnic group)'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",92.0,0.036364,"The theoretically informed, culturally adapted children's weight management programme was highly acceptable to children and families of all ethnicities.","[{'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Pallan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Griffin', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kiya L', 'Initials': 'KL', 'LastName': 'Hurley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Lancashire', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Blissett', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Griffith', 'Affiliation': 'School of Social Policy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'McGee', 'Affiliation': 'Birmingham Community Nutrition, Birmingham Community Healthcare NHS Trust, Birmingham, UK.'}, {'ForeName': 'Janice L', 'Initials': 'JL', 'LastName': 'Thompson', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jackson', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Paramjit', 'Initials': 'P', 'LastName': 'Gill', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Parry', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23330']
1051,29347888,Patient baseline interpersonal problems as moderators of outcome in two psychotherapies for bulimia nervosa.,"Objective: We tested an aptitude by treatment interaction; namely, whether patients' baseline interpersonal problems moderated the comparative efficacy of cognitive-behavioral therapy (CBT) vs. interpersonal psychotherapy (IPT) for bulimia nervosa (BN). Method: Data derived from a randomized-controlled trial. Patients reported on their interpersonal problems at baseline; purge frequency at baseline, midtreatment, and posttreatment; and global eating disorder severity at baseline and posttreatment. We estimated the rate of change in purge frequency across therapy, and the likelihood of attaining clinically meaningful improvement (recovery) in global eating disorder severity by posttreatment. We then tested the interpersonal problem by treatment interactions as predictors of both outcomes. Results: Patients with more baseline overly communal/friendly problems showed steeper reduction in likelihood of purging when treated with CBT vs. IPT. Patients with more problems of being under communal/cold had similar reductions in likelihood of purging across both treatments. Patients with more baseline problems of being overly agentic were more likely to recover when treated with IPT vs. CBT, whereas patients with more problems of being under agentic were more likely to recover when treated with CBT vs. IPT. Conclusions: Interpersonal problems related to communion and agency may inform treatment fit among two empirically supported therapies for BN.",2019,"Patients with more baseline problems of being overly agentic were more likely to recover when treated with IPT vs. CBT, whereas patients with more problems of being under agentic were more likely to recover when treated with CBT vs. IPT. ","['bulimia nervosa (BN', 'Results: Patients with more baseline overly communal/friendly problems', 'bulimia nervosa']","['IPT vs. CBT', 'CBT vs. IPT', 'cognitive-behavioral therapy (CBT) vs. interpersonal psychotherapy (IPT']",['global eating disorder severity'],"[{'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",2.0,0.0872184,"Patients with more baseline problems of being overly agentic were more likely to recover when treated with IPT vs. CBT, whereas patients with more problems of being under agentic were more likely to recover when treated with CBT vs. IPT. ","[{'ForeName': 'Juan Martin', 'Initials': 'JM', 'LastName': 'Gomez Penedo', 'Affiliation': 'a CONICET & Department of Psychology , Universidad de Buenos Aires , Buenos Aires , Argentina.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'b Department of Psychological and Brain Sciences , University of Massachusetts Amherst , Amherst , MA , USA.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Coyne', 'Affiliation': 'b Department of Psychological and Brain Sciences , University of Massachusetts Amherst , Amherst , MA , USA.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Bernecker', 'Affiliation': 'b Department of Psychological and Brain Sciences , University of Massachusetts Amherst , Amherst , MA , USA.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Smith-Hansen', 'Affiliation': 'c Department of Psychology , Suffolk University , Boston , MA , USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2018.1425931']
1052,29347904,Social skills training and play group intervention for children with oppositional-defiant disorders/conduct disorder: Mediating mechanisms in a head-to-head comparison.,"Objective : Social-cognitive information processing, social skills, and social interactions are problem-maintaining variables for aggressive behavior in children. We hypothesized that these factors may be possible mediators of the mechanism of change in the child-centered treatment of conduct disorders (CDs). The aim of the present study (Clinical trials.gov Identifier: NCT01406067) was to examine putative mechanisms of change for the decrease in oppositional-defiant behavior resulting from child-centered treatment of patients with oppositional-defiant disorder (ODD) or CD. Method : 91 children (age 6-12 years) with ODD/CD were randomized to receive either social skills training or to a resource activating play group. Mediator analyses were conducted using path analyses. Results : The assumed mediating effects were not significant. However, alternative models with the putative mediators and outcome in reversed positions showed significant indirect effects of the oppositional-defiant symptoms as mediator for the decrease of disturbance of social-information processing, social skills, and social interactions. Conclusions : The proposed model for mechanisms of change could not be confirmed, with the results pointing to a reversed causality. Variables other than those hypothesized must be responsible for mediating the effects of the intervention on child oppositional-defiant behavior. Possible mechanisms of change were discussed.",2019,Variables other than those hypothesized must be responsible for mediating the effects of the intervention on child oppositional-defiant behavior.,"['children', 'Method : 91 children (age 6-12 years) with ODD/CD', 'patients with oppositional-defiant disorder (ODD) or CD', 'children with oppositional-defiant disorders/conduct disorder']","['social skills training or to a resource activating play group', 'Social skills training and play group intervention']","['child oppositional-defiant behavior', 'oppositional-defiant symptoms', 'oppositional-defiant behavior', 'disturbance of social-information processing, social skills, and social interactions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct Disorder'}]","[{'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0424348', 'cui_str': 'Defiant behavior (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}]",91.0,0.0232468,Variables other than those hypothesized must be responsible for mediating the effects of the intervention on child oppositional-defiant behavior.,"[{'ForeName': 'Josepha', 'Initials': 'J', 'LastName': 'Katzmann', 'Affiliation': 'a School of Child and Adolescent Behavior Therapy , the University Hospital Cologne , Cologne , Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Goertz-Dorten', 'Affiliation': 'a School of Child and Adolescent Behavior Therapy , the University Hospital Cologne , Cologne , Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hautmann', 'Affiliation': 'a School of Child and Adolescent Behavior Therapy , the University Hospital Cologne , Cologne , Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Doepfner', 'Affiliation': 'a School of Child and Adolescent Behavior Therapy , the University Hospital Cologne , Cologne , Germany.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2018.1425559']
1053,31838589,Personal Approach to Treatment Choices for HIV (PATCH): Randomized Controlled Trial of a Brief Motivational Enhancement Intervention to Improve Medication Adherence in Persons with HIV.,"This pilot randomized controlled trial evaluated the feasibility and efficacy of a brief motivational enhancement intervention to improve adherence to antiretroviral therapy in persons with HIV called Personal Approach to Treatment Choices for HIV (PATCH). We compared PATCH to an active control condition on self-reported adherence, clinical outcomes, and psychosocial outcomes. Participants were 34 individuals (61.8% male, M age = 47.1) receiving HIV-related services who were suboptimally engaged in care. Participants completed baseline measures, participated in either PATCH or a stress reduction skills control intervention, and completed post-treatment and 3-month follow-up assessments. Results revealed no differences between conditions on adherence or clinical outcomes. At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months. Results suggest that motivational enhancement interventions can improve psychosocial outcomes for people with HIV. That some improvements were not maintained at follow-up suggests that effects wane over time and longer treatment may be indicated for lasting effects.",2020,"At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months.","['people with HIV', 'HIV (PATCH', 'Persons with HIV', 'Participants were 34 individuals (61.8% male, M age \u2009=\u200947.1) receiving HIV-related services who were suboptimally engaged in care', 'persons with HIV called Personal Approach to Treatment Choices for HIV (PATCH']","['motivational enhancement intervention', 'Motivational Enhancement Intervention', 'motivational enhancement interventions', 'PATCH or a stress reduction skills control intervention, and completed post-treatment and 3-month follow-up assessments']","['psychosocial outcomes', 'Medication Adherence', 'alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]",34.0,0.0572077,"At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Scharer', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': 'Minds in Focus Psychological Services, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Nichols', 'Affiliation': 'Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Medoff', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Himelhoch', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA. mbennett@som.umaryland.edu.'}]",AIDS and behavior,['10.1007/s10461-019-02759-3']
1054,32118385,The effects of leucine and whey protein supplementation with eight weeks of resistance training on strength and body composition.,"BACKGROUND
In past few decades, supplementation has become very popular within professional and recreational athletes. Most interested among supplements are protein and amino acids. Therefore, the purpose of this study was to examine the effects of leucine supplementation in comparison to whey protein supplementation with placebo group on strength and body composition during 8 weeks of resistance training program.
METHODS
Thirty male college athletes (mean age±SD =23.92±1.54 years) participated in this investigation and were randomly assigned to one of three groups: whey protein (WP, N.=10), leucine (LEU, N.=10) or placebo (PLA, N.=10). The WP, LEU and PLA performed resistance training for 8 weeks. Strength (1RM bench press, squat, shoulder press) and maximum pull-ups and body composition has been assessed and data was analyzed with mixed-design analysis of variance (P≤0.01).
RESULTS
The WP group achieved significantly greater (P≤0.01) increases in 1RM bench press than the LEU and PLA groups (+16 kg for WP; + 7.5 kg for LEU and + 5 kg for PLA). The LEU group achieved significantly greater gains (P≤0.01) in fat free mass, muscle mass and significantly decreases (P≤0.01) in fat mass compared to WP and PLA groups.
CONCLUSIONS
Whey protein supplementation in male collegiate athletes during resistance training achieved greater increase in strength than leucine and placebo groups, and leucine group achieved significantly greater improvement in body composition than whey protein and placebo groups.",2020,The WP group achieved significantly greater (p≤0.01) increases in 1RM bench press than the LEU and PLA groups (+16kg for WP; + 7.5kg for LEU and + 5kg for PLA).,"['Thirty male college athletes (mean age ± SD = 23.92 ± 1.54 years', 'male collegiate athletes']","['placebo', 'LEU', 'leucine supplementation', 'leucine and whey protein supplementation', 'whey protein (WP, n=10), leucine (LEU, n=10) or placebo']","['strength', '1RM bench press', 'Strength (1RM bench press, squat, shoulder press) and maximum pull-ups and body composition', 'body composition', 'strength and body composition']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0454325', 'cui_str': 'Shoulder press (regime/therapy)'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",30.0,0.033423,The WP group achieved significantly greater (p≤0.01) increases in 1RM bench press than the LEU and PLA groups (+16kg for WP; + 7.5kg for LEU and + 5kg for PLA).,"[{'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Obradović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Vukadinović Jurišić', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Dušan', 'Initials': 'D', 'LastName': 'Rakonjac', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad, Serbia - rakonjac992@gmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.09742-X']
1055,31837648,A New Approach to Transcranial Direct Current Stimulation in Improving Cognitive Motor Learning and Hand Function with the Nintendo Switch in Stroke Survivors.,"BACKGROUND Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique designed to improve cognitive and physical function of stroke survivors. There are many studies being conducted in the search for an effective intervention of tDCS. This study focused on cognitive motor learning in relation to hand function of stroke survivors. MATERIAL AND METHODS We enrolled 30 subjects with cognitive and hand function disorders. The participants in each group were inpatients at a hospital in Korea and had undergone neurorehabilitation training (60 min). Groups 1 and 3 had tDCS applied for 20 min, while group 2 received sham tDCS for the same duration. Afterwards, groups 1 and 2 played Nintendo games for 20 min, but group 3 did not. The total intervention period was 40 min/day, 2 days/week, for 8 weeks. The cognitive and hand function of the subjects were assessed using the Trail Making Test (TMT-A, TMT-B), Grip strength, Box and Block Test (BBT), and the Manual Function Test (MFT) before and after intervention. RESULTS The tDCS + Nintendo Switch game group showed significant differences in TMT-A, TMT-B, Grip strength, MFT, and BBT results compared to the other groups between before and after intervention (p<.05). CONCLUSIONS Our results suggest that inclusion of motor tasks with the application of tDCS may be effective in improving cognitive and hand function of stroke survivors.",2019,"The tDCS + Nintendo Switch game group showed significant differences in TMT-A, TMT-B, Grip strength, MFT, and BBT results compared to the other groups between before and after intervention (p<.05).","['30 subjects with cognitive and hand function disorders', 'Stroke Survivors', 'participants in each group were inpatients at a hospital in Korea and had undergone neurorehabilitation training (60 min', 'stroke survivors']","['tDCS', 'Transcranial Direct Current Stimulation', 'Transcranial direct current stimulation (tDCS', 'sham tDCS', 'cognitive motor learning']","['Trail Making Test (TMT-A, TMT-B), Grip strength, Box and Block Test (BBT), and the Manual Function Test (MFT', 'TMT-A, TMT-B, Grip strength, MFT, and BBT results']","[{'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",30.0,0.0208235,"The tDCS + Nintendo Switch game group showed significant differences in TMT-A, TMT-B, Grip strength, MFT, and BBT results compared to the other groups between before and after intervention (p<.05).","[{'ForeName': 'JaeEun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Sahmyook University, Seoul, South Korea.'}, {'ForeName': 'MiYoung', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul, South Korea.'}, {'ForeName': 'JongEun', 'Initials': 'J', 'LastName': 'Yim', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul, South Korea.'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.921081']
1056,31285147,"Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial.","BACKGROUND
Opicinumab is a human monoclonal antibody against LINGO-1, an inhibitor of oligodendrocyte differentiation and axonal regeneration. Previous findings suggested that opicinumab treatment might enhance remyelination in patients with CNS demyelinating diseases. We aimed to assess the safety and efficacy of opicinumab in patients with relapsing multiple sclerosis.
METHODS
We did a randomised, double-blind, placebo-controlled, dose-ranging, phase 2 study (SYNERGY) at 72 sites in 12 countries. Participants (aged 18-58 years) with relapsing multiple sclerosis (relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis with relapses) were randomised in a 1:2:2:2:2 ratio by an interactive voice and web response system to opicinumab 3 mg/kg, 10 mg/kg, 30 mg/kg, or 100 mg/kg, or placebo. An identical volume of study drug was administered intravenously once every 4 weeks. All participants self-administered intramuscular interferon beta-1a as background anti-inflammatory treatment once a week. The primary endpoint was the percentage of participants achieving confirmed disability improvement over 72 weeks, which was a multicomponent endpoint measured by the Expanded Disability Status Scale, the Timed 25-Foot Walk, the Nine-Hole Peg Test, and the 3 s Paced Auditory Serial Addition Test. The primary endpoint was analysed under intention-to-treat principles. This study is registered at ClinicalTrials.gov, number NCT01864148.
FINDINGS
Between Aug 13, 2013, and July 31, 2014, 419 patients were enrolled and randomly assigned either placebo (n=93) or opicinumab 3 mg/kg (n=45), 10 mg/kg (n=95), 30 mg/kg (n=94; one patient did not receive the assigned treatment), or 100 mg/kg (n=92). The last patient visit was on March 29, 2016. Confirmed disability improvement over 72 weeks was seen in 45 (49%) of 91 patients assigned to placebo, 21 (47%) of 45 assigned to opicinumab 3 mg/kg, 59 (63%) of 94 assigned to opicinumab 10 mg/kg, 59 (65%) of 91 assigned to opicinumab 30 mg/kg, and 36 (40%) of 91 assigned to opicinumab 100 mg/kg. A linear dose-response in the probability of confirmed disability improvement was not seen (linear trend test p=0·89). Adverse events occurred in 79 (85%) patients assigned placebo and in 275 (85%) assigned any dose of opicinumab. The most common adverse events of any grade in patients assigned any dose of opicinumab included influenza-like illness (140 [43%] with any dose of opicinumab vs 37 [40%] with placebo), multiple sclerosis relapses (117 [36%] vs 30 [32%]), and headache (51 [16%] vs 23 [25%]). Serious adverse events reported as related to treatment were urinary tract infection in one (1%) participant in the the placebo group, suicidal ideation and intentional overdose in one (1%) participant in the 30 mg/kg opicinumab group, bipolar disorder in one (1%) participant in the 100 mg/kg opicinumab group, and hypersensitivity in four (4%) participants in the 100 mg/kg opicinumab group. One patient in the opicinumab 30 mg/kg group died during the study due to a traffic accident, which was not considered related to study treatment.
INTERPRETATION
Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis. Further studies are needed to investigate whether some subpopulations identified in the study might benefit from opicinumab treatment at an optimum dose.
FUNDING
Biogen.",2019,Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis.,"['patients with relapsing multiple sclerosis', 'patients with relapsing multiple sclerosis (SYNERGY', 'patients with CNS demyelinating diseases', '419 patients', 'Between Aug 13, 2013, and July 31, 2014', '72 sites in 12 countries', 'Participants (aged 18-58 years) with relapsing multiple sclerosis (relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis with relapses']","['opicinumab 3 mg/kg', 'placebo', 'opicinumab']","['Expanded Disability Status Scale, the Timed 25-Foot Walk, the Nine-Hole Peg Test, and the 3 s Paced Auditory Serial Addition Test', 'safety and efficacy', 'under intention-to-treat principles', 'Adverse events', 'disability', 'percentage of participants achieving confirmed disability improvement', 'hypersensitivity', 'urinary tract infection', 'bipolar disorder', 'headache', 'influenza-like illness', 'suicidal ideation and intentional overdose', 'multiple sclerosis relapses', 'disability improvement', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0011303', 'cui_str': 'Demyelinating Disorders'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0751965', 'cui_str': 'Multiple Sclerosis, Secondary Progressive'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C4550038', 'cui_str': 'opicinumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test (assessment scale)'}, {'cui': 'C0589060', 'cui_str': 'Paced Auditory Serial Addition Test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0520804', 'cui_str': 'Intentional drug overdose (disorder)'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]",419.0,0.496337,Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis.,"[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cadavid', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Mellion', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hupperts', 'Affiliation': 'Zuyderland Medical Center, Sittard, Netherlands.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Edwards', 'Affiliation': 'Multiple Sclerosis Center of Northeastern New York, Latham, NY, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Calabresi', 'Affiliation': 'The Johns Hopkins Multiple Sclerosis Center, Baltimore, MD, USA.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Drulović', 'Affiliation': 'Clinic of Neurology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Barts & The London School of Medicine & Dentistry, Queen Mary University, London, UK.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, Montreal, QC, Canada; NeuroRx Research, Montreal, QC, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fisher', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rudick', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Mi', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: bing.zhu@biogen.com.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Ih', 'Initials': 'I', 'LastName': 'Chang', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Deykin', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Sarah I', 'Initials': 'SI', 'LastName': 'Sheikh', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30137-1']
1057,32118387,Thirty-two weeks of randomized interdisciplinary therapy or combined physical training promote similar improvements in anthropometric and biochemical parameters of obese women.,"BACKGROUND
Obesity is a multicausal illness that generates large expenses to health systems and also for the families of obese individuals. It is important to note that obesity disrupts all systems, generating metabolic consequences that may be irreversible. Interdisciplinary therapy is recommended as the primary method for treating obesity. However, the cost of interdisciplinary treatment can be high due to the need for various professionals, from different areas of expertise. This study compares the effects of 32 weeks of physical training combined with interdisciplinary therapy on anthropometric and biochemical parameters in obese women.
METHODS
Seventy-six subjects were randomized into two groups: Group Physical Exercise (EXE) and Group Interdisciplinary Treatment (INTER), being evaluated in the initial moment and after 32 weeks. 30 subjects completed the intervention and were evaluated (EXE: N.=13; INTER: N.=17).
RESULTS
Psychobiological and biochemical variables were measured. EXE and INTER were similar before treatment and both showed significantly improvements in anthropometric and biochemical parameters after interventions, without difference between groups.
CONCLUSIONS
The results confirmed the relevant role of physical training or the interdisciplinary therapy on metabolic profile of obese women. We realized that physical training can be incorporated into public or private health systems as an alternative strategy for obesity control, especially in locations that do not have the possibility of offering a complete interdisciplinary therapy.",2020,"EXE and INTER were similar before treatment and both showed significantly improvements in anthropometric and biochemical parameters after interventions, without difference between groups.
","['obese women', '30 subjects completed the intervention and were evaluated (EXE: n=13; INTER: n=17', '76 subjects']","['physical training combined with interdisciplinary therapy', 'Group Physical Exercise (EXE) and Group Interdisciplinary Treatment (INTER', 'interdisciplinary therapy', 'physical training', 'combined physical training']","['anthropometric and biochemical parameters', 'EXE and INTER']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",76.0,0.0391068,"EXE and INTER were similar before treatment and both showed significantly improvements in anthropometric and biochemical parameters after interventions, without difference between groups.
","[{'ForeName': 'Letícia A', 'Initials': 'LA', 'LastName': 'Cerrone', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil - leticia.ac9@gmail.com.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Caranti', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Fidalgo', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Ricardo B', 'Initials': 'RB', 'LastName': 'Sanches', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Maythe A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Renata R', 'Initials': 'RR', 'LastName': 'Astride', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Vanessa F', 'Initials': 'VF', 'LastName': 'Poli', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'de Campos', 'Affiliation': 'Cellula Mater Laboratory, Santos, SP, Brazil.'}, {'ForeName': 'Lila M', 'Initials': 'LM', 'LastName': 'Oyama', 'Affiliation': 'Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Liu C', 'Initials': 'LC', 'LastName': 'Yi', 'Affiliation': 'Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Dâmaso', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Cauê V', 'Initials': 'CV', 'LastName': 'Teixeira', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Ricardo J', 'Initials': 'RJ', 'LastName': 'Gomes', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10036-7']
1058,31246258,Cognitive Rehabilitation and Exposure/Sorting Therapy for Late-Life Hoarding: Effects on Neuropsychological Performance.,"OBJECTIVES
Hoarding disorder (HD) is characterized by urges to save items, difficulty discarding possessions, and excessive clutter and has been associated with executive functioning deficits. A randomized controlled trial comparing Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) with a care management control condition demonstrated the efficacy of CREST in reducing hoarding symptoms in older adults. The purpose of the current study was to assess whether CREST may also lead to improved executive functioning.
METHOD
All participants were administered a neurocognitive battery at baseline and posttreatment. Linear mixed models with random intercepts were used to evaluate change in global neuropsychological functioning as well as change in individual executive functioning variables.
RESULTS
There was no significant group by time interaction for the Global Deficit score; however, there were significant group by time interactions on two of the executive functioning variables examined, such that participants in the CREST condition demonstrated significant improvement in cognitive flexibility and inhibition over time compared with the participants in the care management condition.
DISCUSSION
Our initial findings support the notion that CREST may be able to improve task switching, an important component of executive functioning, in older adults with HD.",2020,"There was no significant group by time interaction for the Global Deficit score; however, there were significant group by time interactions on two of the executive functioning variables examined, such that participants in the CREST condition demonstrated significant improvement in cognitive flexibility and inhibition over time compared with the participants in the care management condition.
","['older adults with HD', 'Late-Life Hoarding', 'older adults']","['Cognitive Rehabilitation and Exposure/Sorting Therapy', 'Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST', 'CREST']","['cognitive flexibility and inhibition over time', 'Global Deficit score', 'hoarding symptoms', 'global neuropsychological functioning']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0424337', 'cui_str': 'Hoarding'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2948667', 'cui_str': 'Crest'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424337', 'cui_str': 'Hoarding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0444116,"There was no significant group by time interaction for the Global Deficit score; however, there were significant group by time interactions on two of the executive functioning variables examined, such that participants in the CREST condition demonstrated significant improvement in cognitive flexibility and inhibition over time compared with the participants in the care management condition.
","[{'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Ayers', 'Affiliation': 'Mental Healthcare Line, VA San Diego Healthcare System, California.'}, {'ForeName': 'Eliza J', 'Initials': 'EJ', 'LastName': 'Davidson', 'Affiliation': 'Research Service, VA San Diego Healthcare System, California.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Dozier', 'Affiliation': 'Research Service, VA San Diego Healthcare System, California.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Twamley', 'Affiliation': 'Department of Psychiatry, University of California, San Diego School of Medicine, La Jolla.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz062']
1059,31744005,Sixteen-Week Interventional Study to Evaluate the Clinical Effects and Safety of Rivastigmine Capsules in Chinese Patients with Alzheimer's Disease.,"BACKGROUND
Rivastigmine is a cholinesterase inhibitor, approved for the treatment of mild-to-moderate dementia of Alzheimer's type.
OBJECTIVE
To explore the efficacy and safety of the maximal tolerated dose of rivastigmine capsules in Chinese patients with mild-to-moderate Alzheimer's disease (AD).
METHODS
The study was a multicenter, open-label, single-arm, phase IV clinical study in mild-to-moderate drug-naïve AD patients treated with rivastigmine capsules. The primary endpoint was the changes in the total scores of Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) from baseline to week 16. Secondary endpoints included changes in the scores of the following assessment scales and safety: Alzheimer's Disease Cooperative Study; Activities of Daily Living; Mini-Mental Status Examination (MMSE); Neuropsychiatry Index (NPI), and Caregiver Burden Inventory.
RESULTS
222 patients were enrolled. Of these, 136 (75.1%) patients received and maintained the effective dose (≥6 mg/d) of rivastigmine for at least 4 weeks. The ADAS-Cog scale score improved in rivastigmine-treated patients at week 16 compared with baseline (p < 0.001) by 2.0 (95% CI: -3.0 to -1.1) points, which met the pre-defined superiority criteria. NPI-10 and NPI-12 scores improved by 3.6 and 4.0 points at week 16 (p = 0.001, p < 0.001), respectively. A total of 107 patients (59.1%) experienced adverse effects (AEs) during the study; common AEs included nausea (20.5%), vomiting (16.6%), anorexia (7.8%), dizziness (7.7%), and diarrhea (7.2%).
CONCLUSION
This was the first phase IV study on rivastigmine in mainland China. The study preliminarily demonstrated that rivastigmine capsules showed good tolerability and efficacy in mild-to-moderate AD patients with the maximal tolerated dose.",2019,"A total of 107 patients (59.1%) experienced adverse effects (AEs) during the study; common AEs included nausea (20.5%), vomiting (16.6%), anorexia (7.8%), dizziness (7.7%), and diarrhea (7.2%).
","[""mild-to-moderate dementia of Alzheimer's type"", ""Chinese Patients with Alzheimer's Disease"", ""Chinese patients with mild-to-moderate Alzheimer's disease (AD"", 'mild-to-moderate drug-naïve AD patients treated with', '222 patients were enrolled']","['Rivastigmine Capsules', 'rivastigmine capsules', 'rivastigmine']","['ADAS-Cog scale score', 'NPI-10 and NPI-12 scores', 'dizziness', 'diarrhea', ""total scores of Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog"", ""changes in the scores of the following assessment scales and safety: Alzheimer's Disease Cooperative Study; Activities of Daily Living"", 'efficacy and safety', 'Mini-Mental Status Examination (MMSE); Neuropsychiatry Index (NPI), and Caregiver Burden Inventory', 'vomiting', 'tolerability and efficacy', 'adverse effects (AEs', 'anorexia', 'nausea']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0870956', 'cui_str': 'Neuropsychiatry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",222.0,0.274445,"A total of 107 patients (59.1%) experienced adverse effects (AEs) during the study; common AEs included nausea (20.5%), vomiting (16.6%), anorexia (7.8%), dizziness (7.7%), and diarrhea (7.2%).
","[{'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Cognitive Disorder, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'China National Clinical Research Center for Neurological Disease, Beijing, China.'}, {'ForeName': 'Qinyong', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Department of Neurology, The Affiliated Union Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Dantao', 'Initials': 'D', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Kuang', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Department of Psychiatry, Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China.'}, {'ForeName': 'Zhihou', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, Affiliated Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Wenshi', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Geriatrics, Huadong Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yansheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shifu', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': ""Department of Geriatric Psychiatry, Alzheimer's Disease and Related Disorders' Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, China.""}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190791']
1060,31202690,"Low-dose ritonavir-boosted darunavir once daily versus ritonavir-boosted lopinavir for participants with less than 50 HIV RNA copies per mL (WRHI 052): a randomised, open-label, phase 3, non-inferiority trial.","BACKGROUND
Pilot studies suggest that ritonavir-boosted darunavir could show high efficacy at doses below those currently approved. We investigated whether switch to 400 mg of darunavir boosted with 100 mg ritonavir once daily could show equivalent efficacy to continuation of ritonavir-boosted lopinavir (a protease inhibitor commonly used in low-income and middle-income countries) for individuals with HIV RNA suppression.
METHODS
In the WRHI 052 study, a randomised, parallel-group, open-label, non-inferiority phase 3 trial, adults who were HIV-1 positive were enrolled in Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa. Eligible participants were 18 years or older, who tolerated ritonavir-boosted lopinavir in combination with two nucleoside analogues (standard of care) for 6 months or more, and had plasma HIV-1 RNA of less than 50 copies per mL within 60 days of enrolment. We randomly assigned participants (1:1), using a computer-generated randomisation plan, to switch to darunavir (400 mg) boosted with ritonavir (100 mg) once daily or remain on ritonavir-boosted lopinavir (800 mg [plus 200 mg ritonavir]), with nucleoside analogues left unchanged. The primary endpoint was the proportion of patients with less than 50 HIV-1 RNA copies per mL at week 48 (US Food and Drug Administration snapshot algorithm; non-inferiority margin -4%). Primary and safety analyses included participants receiving at least one dose of darunavir boosted with ritonavir. This trial is registered with ClinicalTrials.gov, number NCT02671383.
FINDINGS
Between June 30, 2016, and June 15, 2017, 148 participants were assigned to ritonavir-boosted darunavir 400 mg and 152 continued on their lopinavir-containing regimen. Four (3%) patients in the darunavir group and three (2%) in the lopinavir group discontinued before week 48. At week 48, darunavir was non-inferior to lopinavir for the primary outcome (142 [96%] of 148 participants on darunavir had <50 HIV-1 RNA copies per mL vs 143 [94%] of 152 participants on lopinavir; difference 1·9% [95% CI -3·4 to 7·3]), with a predefined margin of -4%. More participants taking darunavir (30 [20%] participants) had drug-related adverse events than those on lopinavir (eight [5%]), but the adverse events were generally asymptomatic and resolved when switching back to lopinavir. Elevated liver transaminase in three (1%; one symptomatic) darunavir participants led to study withdrawal; all transaminase elevations resolved on restarting lopinavir.
INTERPRETATION
Low-dose ritonavir-boosted darunavir might be a safe and efficacious switch option to maintain HIV suppression for patients on lopinavir. However, an adequately powered and designed study in viraemic participants is needed.
FUNDING
South African Medical Research Council, United States Agency for International Development, and US National Institute of Allergy and Infectious Diseases.",2019,"At week 48, darunavir was non-inferior to lopinavir for the primary outcome (142 [96%] of 148 participants on darunavir had <50 HIV-1 RNA copies per mL vs 143 [94%] of 152 participants on lopinavir; difference 1·9% [95% CI -3·4 to 7·3]), with a predefined margin of -4%.","['Eligible participants were 18 years or older, who tolerated ritonavir-boosted lopinavir in combination with two nucleoside analogues (standard of care) for 6 months or more, and had plasma HIV-1 RNA of less than 50 copies per mL within 60 days of enrolment', 'viraemic participants', 'Between June 30, 2016, and June 15, 2017', '148 participants were assigned to', 'participants with less than 50 HIV RNA copies per mL (WRHI 052', 'adults who were HIV-1 positive were enrolled in Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa', 'low-income and middle-income countries) for individuals with HIV RNA suppression', 'participants receiving at least one dose of darunavir boosted with']","['lopinavir', 'ritonavir-boosted lopinavir', 'ritonavir', 'Low-dose ritonavir-boosted darunavir once daily versus ritonavir-boosted lopinavir', 'darunavir (400 mg) boosted with ritonavir (100 mg) once daily or remain on ritonavir-boosted lopinavir (800 mg [plus 200 mg ritonavir', 'ritonavir-boosted darunavir']","['Elevated liver transaminase', 'adverse events', 'drug-related adverse events', 'proportion of patients with less than 50 HIV-1 RNA']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside Analogs'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",148.0,0.437795,"At week 48, darunavir was non-inferior to lopinavir for the primary outcome (142 [96%] of 148 participants on darunavir had <50 HIV-1 RNA copies per mL vs 143 [94%] of 152 participants on lopinavir; difference 1·9% [95% CI -3·4 to 7·3]), with a predefined margin of -4%.","[{'ForeName': 'Willem D F', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: fventer@wrhi.ac.za.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Moorhouse', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Simiso', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Celicia', 'Initials': 'C', 'LastName': 'Serenata', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ambar', 'Initials': 'A', 'LastName': 'Qavi', 'Affiliation': 'Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Nonkululeko', 'Initials': 'N', 'LastName': 'Mashabane', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Arulappan', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Joel W', 'Initials': 'JW', 'LastName': 'Sim', 'Affiliation': 'Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Phumla Z', 'Initials': 'PZ', 'LastName': 'Sinxadi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lubbe', 'Initials': 'L', 'LastName': 'Wiesner', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ellisha', 'Initials': 'E', 'LastName': 'Maharaj', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Wallis', 'Affiliation': 'BARC, Lancet Laboratories, Johannesburg, South Africa.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Boyles', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ripin', 'Affiliation': 'Clinton Health Access Initiative, Boston, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Stacey', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Division of Infectious Diseases, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Gila', 'Initials': 'G', 'LastName': 'Chitauri', 'Affiliation': 'Division of Infectious Diseases, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30081-5']
1061,31255386,Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial.,"The PDA: TO LEave it alone or Respond And Treat Early trial compared the effects of 2 strategies for treatment of patent ductus arteriosus (PDA) in infants <28 0/7 weeks of gestation; however 137 potentially eligible infants were not recruited and received treatment of their PDA outside the PDA-TOLERATE trial due to ""lack-of-physician-equipoise"" (LPE). Despite being less mature and needing more respiratory support, infants with LPE had lower rates of mortality than enrolled infants. Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01958320.",2019,Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6.,"['Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial', 'patent ductus arteriosus (PDA) in infants <28 0/7 \xa0weeks of gestation; however\xa0137 potentially eligible infants']",['PDA'],"['rates of mortality', 'rates of late respiratory morbidity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}]",137.0,0.0900913,Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Liebowitz', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Katheria', 'Affiliation': 'Department of Pediatrics, Sharp Mary Birch Hospital for Women and Newborns, San Diego, CA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Sauberan', 'Affiliation': 'Department of Pediatrics, Sharp Mary Birch Hospital for Women and Newborns, San Diego, CA.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Department of Pediatrics, University of Chicago, Chicago, IL.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Nelson', 'Affiliation': 'Department of Pediatrics, University of Chicago, Chicago, IL.'}, {'ForeName': 'Denise C', 'Initials': 'DC', 'LastName': 'Hassinger', 'Affiliation': 'Department of Pediatrics, Morristown Medical Center, Morristown, NJ.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Aucott', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kaempf', 'Affiliation': 'Department of Pediatrics, Providence St Vincent Medical Center, Portland, OR.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kimball', 'Affiliation': ""Department of Pediatrics, University of California San Diego and Rady Children's Hospital, San Diego, CA.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Fernandez', 'Affiliation': ""Department of Pediatrics, University of California San Diego and Rady Children's Hospital, San Diego, CA.""}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Carey', 'Affiliation': 'Department of Pediatrics, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Department of Pediatrics, South Miami Hospital/Baptist Health South Florida, Miami, FL.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Serize', 'Affiliation': 'Department of Pediatrics, South Miami Hospital/Baptist Health South Florida, Miami, FL.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wickremasinghe', 'Affiliation': 'Department of Pediatrics, Kaiser Permanente Medical Center, Santa Clara, CA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Pediatrics, Kaiser Permanente Medical Center, Santa Clara, CA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Derrick', 'Affiliation': 'Department of Pediatrics, Northshore University Health System, Evanston, IL.'}, {'ForeName': 'Ilene Sue', 'Initials': 'IS', 'LastName': 'Wolf', 'Affiliation': 'Department of Pediatrics, Northshore University Health System, Evanston, IL.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Heuchan', 'Affiliation': 'Department of Pediatrics, University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Sankar', 'Affiliation': 'Department of Pediatrics, Mednax Medical Group, Good Samaritan Hospital, San Jose, CA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bulbul', 'Affiliation': 'Department of Pediatrics, Sisli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Ronald I', 'Initials': 'RI', 'LastName': 'Clyman', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA; Cardiovascular Research Institute, University of California San Francisco, San Francisco, CA. Electronic address: clymanr@peds.ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.05.049']
1062,30712461,"A Pilot Investigation of Repetitive Transcranial Magnetic Stimulation for Post-Traumatic Brain Injury Depression: Safety, Tolerability, and Efficacy.","Depression following a traumatic brain injury (TBI) is common and difficult to treat using standard approaches. The current study investigated, for the first time, transcranial magnetic stimulation (TMS) for the treatment of post TBI depression. We specifically assessed the safety, tolerability, and efficacy of TMS in this patient population. We also explored cognitive outcomes. Twenty-one patients with a current episode of major depression subsequent to a TBI participated in a randomized double-blind placebo-controlled trial of repetitive TMS (rTMS). Sequential bilateral rTMS (to the left and right dorsolateral prefrontal cortex) was provided in 20 treatments over a period of 4 weeks. Patients were randomly allocated to receive either active or sham stimulation. There were no adverse effects and treatment was well tolerated. There was no significant effect of rTMS on post-TBI depression, with all patients showing a significant improvement in depressive symptoms irrespective of their treatment group ( p = 0.002). There were significant improvements in cognition following active rTMS in the areas of working memory ( p = 0.021) and executive function ( p = 0.029). rTMS was shown to be safe and well tolerated in patients who had developed depression after a TBI. We did not find a therapeutic effect for post-TBI depression; however, this approach may have some utility in improving cognitive function. Future research should focus on alternative rTMS treatment approaches for post-TBI depression and the direct investigation of rTMS as a treatment for cognitive impairment in TBI.",2019,There were significant improvements in cognition following active rTMS in the areas of working memory ( p = 0.021) and executive function ( p = 0.029).,"['Post-Traumatic Brain Injury Depression', 'Twenty-one patients with a current episode of major depression subsequent to a TBI participated', 'patients who had developed depression after a TBI']","['active or sham stimulation', 'placebo', 'TMS', 'transcranial magnetic stimulation (TMS', 'Repetitive Transcranial Magnetic Stimulation', 'Sequential bilateral rTMS', 'repetitive TMS (rTMS', 'rTMS']","['safe and well tolerated', 'tolerated', 'depressive symptoms', 'safety, tolerability, and efficacy', 'executive function', 'post-TBI depression', 'cognition following active rTMS']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",21.0,0.126677,There were significant improvements in cognition following active rTMS in the areas of working memory ( p = 0.021) and executive function ( p = 0.029).,"[{'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McQueen', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Elliot', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Herring', 'Affiliation': '2 Epworth Centre for Innovation in Mental Health, Epworth HealthCare, Camberwell, Victoria, Australia.'}, {'ForeName': 'Jerome J', 'Initials': 'JJ', 'LastName': 'Maller', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': '1 Monash Alfred Psychiatry Research Centre, Monash University and Alfred Health, Central Clinical School, Victoria, Australia.'}]",Journal of neurotrauma,['10.1089/neu.2018.6097']
1063,31278067,"Safety and efficacy of epigallocatechin gallate in multiple system atrophy (PROMESA): a randomised, double-blind, placebo-controlled trial.","BACKGROUND
Multiple system atrophy is a rare neurodegenerative disease characterised by aggregation of α-synuclein in oligodendrocytes and neurons. The polyphenol epigallocatechin gallate inhibits α-synuclein aggregation and reduces associated toxicity. We aimed to establish if epigallocatechin gallate could safely slow disease progression in patients with multiple system atrophy.
METHODS
We did a randomised, double-blind, parallel group, placebo-controlled clinical trial at 12 specialist centres in Germany. Eligible participants were older than 30 years; met consensus criteria for possible or probable multiple system atrophy and could ambulate independently (ie, were at Hoehn and Yahr stages 1-3); and were on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens (if necessary) for at least 1 month. Participants were randomly assigned (1:1) to epigallocatechin gallate or placebo (mannitol) via a web-generated permuted blockwise randomisation list (block size=2) that was stratified by disease subtype (parkinsonism-predominant disease vs cerebellar-ataxia-predominant disease). All participants and study personnel were masked to treatment assignment. Participants were given one hard gelatin capsule (containing either 400 mg epigallocatechin gallate or mannitol) orally once daily for 4 weeks, then one capsule twice daily for 4 weeks, and then one capsule three times daily for 40 weeks. After 48 weeks, all patients underwent a 4-week wash-out period. The primary endpoint was change in motor examination score of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 52 weeks. Efficacy analyses were done in all people who received at least one dose of study medication. Safety was analysed in all people who received at least one dose of the study medication to which they had been randomly assigned. This trial is registered with ClinicalTrials.gov (NCT02008721) and EudraCT (2012-000928-18), and is completed.
FINDINGS
Between April 23, 2014, and Sept 3, 2015, 127 participants were screened and 92 were randomly assigned-47 to epigallocatechin gallate and 45 to placebo. Of these, 67 completed treatment and 64 completed the study (altough one of these patients had a major protocol violation). There was no evidence of a difference in the mean change from baseline to week 52 in motor examination scores on UMSARS between the epigallocatechin gallate (5·66 [SE 1·01]) and placebo (6·60 [0·99]) groups (mean difference -0·94 [SE 1·41; 95% CI -3·71 to 1·83]; p=0·51). Four patients in the epigallocatechin gallate group and two in the placebo group died. Two patients in the epigallocatechin gallate group had to stop treatment because of hepatotoxicity.
INTERPRETATION
48 weeks of epigallocatechin gallate treatment did not modify disease progression in patients with multiple system atrophy. Epigallocatechin gallate was overall well tolerated but was associated with hepatotoxic effects in some patients, and thus doses of more than 1200 mg should not be used.
FUNDING
ParkinsonFonds Deutschland, German Parkinson Society, German Neurology Foundation, Lüneburg Foundation, Bischof Dr Karl Golser Foundation, and Dr Arthur Arnstein Foundation.",2019,There was no evidence of a difference in the mean change from baseline to week 52 in motor examination scores on UMSARS between the epigallocatechin gallate (5·66 [SE 1·01]) and placebo (6·60 [0·99]) groups (mean difference -0·94 [SE 1·41; 95% CI -3·71 to 1·83]; p=0·51).,"['12 specialist centres in Germany', 'patients with multiple system atrophy', '67 completed treatment and 64 completed the study (altough one of these patients had a major protocol violation', 'multiple system atrophy (PROMESA', 'Between April 23, 2014, and Sept 3, 2015, 127 participants were screened and 92 were randomly assigned-47 to epigallocatechin gallate and 45 to', ""Eligible participants were older than 30 years; met consensus criteria for possible or probable multiple system atrophy and could ambulate independently (ie, were at Hoehn and Yahr stages 1-3); and were on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens (if necessary) for at least 1 month"", 'all people who received at least one dose of the study medication to which they had been randomly assigned']","['placebo', 'EudraCT', 'hard gelatin capsule (containing either 400 mg epigallocatechin gallate or mannitol', 'epigallocatechin gallate', 'epigallocatechin gallate treatment', 'epigallocatechin gallate or placebo (mannitol) via a web-generated permuted blockwise randomisation list (block size=2']","['hepatotoxicity', 'toxicity', 'Safety and efficacy', 'hepatotoxic effects', 'change in motor examination score of the Unified Multiple System Atrophy Rating Scale (UMSARS', 'Safety']","[{'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0393571', 'cui_str': 'Multiple System Atrophy Syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0393571', 'cui_str': 'Multiple System Atrophy Syndrome'}, {'cui': 'C0222045'}]",127.0,0.6823,There was no evidence of a difference in the mean change from baseline to week 52 in motor examination scores on UMSARS between the epigallocatechin gallate (5·66 [SE 1·01]) and placebo (6·60 [0·99]) groups (mean difference -0·94 [SE 1·41; 95% CI -3·71 to 1·83]; p=0·51).,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians-University Munich, Munich, Germany; German Center for Neurodegenerative Diseases, Munich, Germany; Munich Cluster for Systems Neurology, Munich, Germany.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Maaß', 'Affiliation': 'German Center for Neurodegenerative Diseases, Munich, Germany; Munich Cluster for Systems Neurology, Munich, Germany; Department of Neurology, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Schuberth', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Giese', 'Affiliation': 'Center for Neuropathology and Prion Research, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Oertel', 'Affiliation': 'Department of Neurology, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurobiology, Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Trenkwalder', 'Affiliation': 'Paracelsus-Elena-Klinik, Kassel, Germany; Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Gregor K', 'Initials': 'GK', 'LastName': 'Wenning', 'Affiliation': 'Department of Neurobiology, Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Südmeyer', 'Affiliation': 'Institute of Clinical Neuroscience and Medical Psychology, Heinrich-Heine-University, Düsseldorf, Germany.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Eggert', 'Affiliation': 'Department of Neurology, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Brit', 'Initials': 'B', 'LastName': 'Mollenhauer', 'Affiliation': 'Paracelsus-Elena-Klinik, Kassel, Germany; Department of Neurology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Lipp', 'Affiliation': 'Department of Neurology, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Löhle', 'Affiliation': 'Department of Neurology, University of Rostock, Rostock, Germany; German Center for Neurodegenerative Diseases, Rostock, Germany; Department of Neurology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Classen', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Münchau', 'Affiliation': 'Institute of Neurogenetics, University of Leipzig, Leipzig Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kassubek', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Gandor', 'Affiliation': 'Movement Disorders Hospital, Beelitz-Heilstätten, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Berg', 'Affiliation': 'Department of Neurodegeneration, Hertie-Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany; Department of Neurology, Christian-Albrechts-University Kiel, Kiel, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Egert-Schwender', 'Affiliation': 'Münchner Studienzentrum, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Eberhardt', 'Affiliation': 'Pharmacy Department, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Max Delbrueck Center for Molecular Medicine, NeuroCure Experimental and Clinical Research Center, Berlin, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Bötzel', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Ertl-Wagner', 'Affiliation': 'Department of Radiology, Ludwig-Maximilians-University Munich, Munich, Germany; Department of Radiology, The Hopsital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Huppertz', 'Affiliation': 'Swiss Epilepsy Clinic, Klinik Lengg, Zurich, Switzerland.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ricard', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Günter U', 'Initials': 'GU', 'LastName': 'Höglinger', 'Affiliation': 'German Center for Neurodegenerative Diseases, Munich, Germany; Department of Neurology, Technical University Munich, Munich, Germany; Department of Neurology, Hanover Medical School, Hanover, Germany. Electronic address: guenter.hoeglinger@dzne.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30141-3']
1064,30312394,A disruptive cue improves handwashing in school children in Zambia.,"Behavioral economics hold great promise in changing patterns of behavior that influence human health. Handwashing with soap is one such behavior that is important in reducing exposure to pathogens, and in school-age children, handwashing helps reduce absenteeism through the prevention of respiratory and diarrheal diseases. However, the gap between knowledge on the importance of handwashing and actual handwashing practice, especially with soap, persists. Many traditional behavior change communication approaches have failed in achieving and sustaining improved handwashing practices. Cognitive psychology research on habits as well as nudge theory, a component of behavioral economics predicated on the idea of making a behavior as easy as possible to do, suggests that introducing a disruptive cue into the environment may be able to interrupt current habitual neurological patterns to effect and then sustain behavior change. We used a participatory process to identify and introduce a locally appropriate disruptive cue to improve handwashing behavior in schools in Zambia. We then utilized a school-randomized controlled trial to test the soap-on-a-rope in 50 government schools in Namwala District of Southern Province. Two outcomes were considered among school children; washing hands with water and using soap while washing hands. Following the intervention, soap use was more likely in intervention schools than control schools [Odds ratio = 7.23, 95% confidence interval = (1.76-29.71)], though both intervention and control schools saw an increase in handwashing without soap. This low-cost intervention could be scaled throughout Zambia and may work well in other countries of similar circumstances.",2019,"Following the intervention, soap use was more likely in intervention schools than control schools [Odds ratio = 7.23, 95% confidence interval = (1.76-29.71)], though both intervention and control schools saw an increase in handwashing without soap.","['50 government schools in Namwala District of Southern Province', 'schools in Zambia', 'school children in Zambia']",['soap-on-a-rope'],['handwashing without soap'],"[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}]","[{'cui': 'C0037392', 'cui_str': 'Soap'}]","[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}]",2.0,0.0206413,"Following the intervention, soap use was more likely in intervention schools than control schools [Odds ratio = 7.23, 95% confidence interval = (1.76-29.71)], though both intervention and control schools saw an increase in handwashing without soap.","[{'ForeName': 'Tabonga', 'Initials': 'T', 'LastName': 'Naluonde', 'Affiliation': 'Akros, Lusaka, Zambia.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wakefield', 'Affiliation': 'Manoff Group, Washington, DC 20008, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Markle', 'Affiliation': 'Akros, Lusaka, Zambia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Akros, Lusaka, Zambia.'}, {'ForeName': 'Chanda', 'Initials': 'C', 'LastName': 'Tresphor', 'Affiliation': 'Ministry of General Education, Lusaka, Zambia.'}, {'ForeName': 'Rim', 'Initials': 'R', 'LastName': 'Abdullah', 'Affiliation': 'Department of Public Health, Food Studies, and Nutrition, Syracuse University, Syracuse 131244, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Larsen', 'Affiliation': 'Department of Public Health, Food Studies, and Nutrition, Syracuse University, Syracuse 131244, USA.'}]",Health promotion international,['10.1093/heapro/day080']
1065,31268223,"Group-based, individualized, comprehensive core stability and balance intervention provides immediate and long-term improvements in walking in individuals with multiple sclerosis: A randomized controlled trial.","OBJECTIVES
Walking impairments are common in individuals with multiple sclerosis. Trunk control is a prerequisite for walking; however, knowledge regarding whether core stability and balance training influence walking is limited. This study aimed to investigate the immediate and long-term effects of a group-based, individualized, comprehensive core stability and balance intervention (GroupCoreDIST) compared with those of standard care on walking.
METHODS
This assessor-blinded, prospective randomized controlled trial included 80 participants (Expanded Disability Status Scale scores 1-6.5) randomly allocated to GroupCoreDIST, conducted in groups of three for 60 min three times per week for 6 weeks (18 sessions) or standard care (n = 40/40). One participant attended no posttests, leaving 79 subjects for intention-to-treat analysis. The assessments were performed at baseline and at Weeks 7, 18, and 30. Outcomes included the 2-min walk test (2MWT), 10-m walk test-preferred/fast/slow speed (10MWT), Multiple Sclerosis Walking Scale-12 (MSWS-12), Patient Global Impression of Change-walking (PGIC-walking), Rivermead Visual Gait Assessment (RVGA), and ActiGraphsWgt3X-BT activity monitors (ActiGraph). The statistical analyses included repeated-measures mixed models performed in IBM SPSS Version 24.
RESULTS
There were no significant between-group differences in the outcome measurements at baseline. The mean differences between groups were significant at all follow-up time points in favour of GroupCoreDIST for the 2MWT, 16.7 m at 7 weeks (95% CI [8.15, 25.25], 15.08 m at 18 weeks (95% CI [6.39, 23.77]) and 16.38 m at 30 weeks (95% CI [7.65, 25.12]; and the PGIC-walking, 0.89 points at 7 weeks (95% CI [1.34, 0.45]), 0.97 points at 18 weeks (95% CI [1.42, 0.52]), and 0.93 points at 30 weeks (95% CI [1.39, 0.48]; all p ≤ .001). The 10MWT-fast speed and the MSWS-12 showed significant between-group differences at 7 and 18 weeks and the RVGA at 7 weeks. No between-group differences were found regarding activity level (ActiGraph) or the 10MWT-preferred or slow speed.
CONCLUSION
Compared with standard care, GroupCoreDIST significantly improved walking immediately after the intervention for up to 24 weeks of follow-up.",2020,The 10MWT-fast speed and the MSWS-12 showed significant between-group differences at 7 and 18 weeks and the RVGA at 7 weeks.,"['individuals with multiple sclerosis', '80 participants (Expanded Disability Status Scale scores 1-6.5) randomly allocated to']","['group-based, individualized, comprehensive core stability and balance intervention (GroupCoreDIST', 'individualized, comprehensive core stability and balance intervention provides immediate and long-term improvements in walking', 'GroupCoreDIST']","['activity level (ActiGraph) or the 10MWT-preferred or slow speed', '2-min walk test (2MWT), 10-m walk test-preferred/fast/slow speed (10MWT), Multiple Sclerosis Walking Scale-12 (MSWS-12), Patient Global Impression of Change-walking (PGIC-walking), Rivermead Visual Gait Assessment (RVGA), and ActiGraphsWgt3X-BT activity monitors (ActiGraph']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]",80.0,0.101518,The 10MWT-fast speed and the MSWS-12 showed significant between-group differences at 7 and 18 weeks and the RVGA at 7 weeks.,"[{'ForeName': 'Ellen Christin', 'Initials': 'EC', 'LastName': 'Arntzen', 'Affiliation': 'Department of Physiotherapy, Nordland Hospital Trust, Bodø, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Straume', 'Affiliation': 'Department of Community Medicine, Faculty of Health Sciences, UiT, The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Odeh', 'Affiliation': 'Institute for Clinical Medicine, Faculty of Health Science, UiT, The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'BIOMED/REVAL, University of Hasselt, Diepenbeek, Belgium.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Normann', 'Affiliation': 'Department of Physiotherapy, Nordland Hospital Trust, Bodø, Norway.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1798']
1066,30174224,The Influence of Auditory Feedback and Vocal Rehabilitation on Prelingual Hearing-Impaired Individuals Post Cochlear Implant.,"OBJECTIVE
To verify changes in the perceptual and acoustic vocal parameters in prelingual hearing-impaired adults with cochlear implants after vocal rehabilitation.
HYPOTHESIS
Auditory feedback restoration alone after cochlear implant is not enough for vocal adjustments. A targeted and specific voice therapy intervention is required.
STUDY DESIGN
Prospective and pre-post repeated measures design.
METHODS
Twenty literate adults with severe to profound prelingual bilateral sensorineural hearing loss participated in the study; individuals were implanted late and were fluent users of oral language. Ages ranged from 17 to 48 years. All individuals presented normal results in laryngoscopy, and hearing thresholds with the cochlear implant were over 40 dB HL. Individuals were randomly distributed into two groups: Group 1 (treatment group) and Group 2 (control group), both with ten patients each, five men and five women, matching mean age and hearing deprivation time before the cochlear implantation. Patients from Group 1 underwent a protocol of vocal therapy including 12 individual sessions with the same clinician. Group 2 only underwent vocal recordings. The vocal recordings occurred before and after the participation in the therapy protocol for Group 1 and after the same period, 3 months later, without any intervention, for Group 2. The recording sessions used the Consensus Auditory-Perceptual Evaluation of Voice protocol sentence reading and emission of sustained vowel /a/. Auditory-perceptual evaluation of voices was performed by three judges, and the acoustical analysis used the Praat program.
RESULTS
Statistically significant reductions in the overall vocal degree, vocal instability, and degree of resonance change were observed after vocal rehabilitation in Group 1. Statistically, individuals from Group 1 did not differ in regard to the modification of acoustic parameters. Group 2 did not present significant changes in any of the analyzed parameters.
CONCLUSIONS
The cochlear implanted adults submitted to vocal rehabilitation presented changes in the auditory-perceptual parameters, with reduction of the overall voice severity, vocal instability, and degree of resonance after vocal intervention. There were no changes in the acoustic parameters in the implanted prelingual hearing-impaired adult subjects.",2019,"The cochlear implanted adults submitted to vocal rehabilitation presented changes in the auditory-perceptual parameters, with reduction of the overall voice severity, vocal instability, and degree of resonance after vocal intervention.","['Twenty literate adults with severe to profound prelingual bilateral sensorineural hearing loss participated in the study; individuals were implanted late and were fluent users of oral language', 'Prelingual Hearing-Impaired Individuals Post Cochlear Implant', 'Ages ranged from 17 to 48 years', 'prelingual hearing-impaired adults with cochlear implants after vocal rehabilitation']","['specific voice therapy intervention', 'protocol of vocal therapy', 'Auditory Feedback and Vocal Rehabilitation', 'vocal rehabilitation']","['acoustic parameters', 'auditory-perceptual parameters', 'overall vocal degree, vocal instability, and degree of resonance change', 'hearing deprivation time', 'overall voice severity, vocal instability, and degree of resonance', 'vocal recordings']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439808', 'cui_str': 'Profundis'}, {'cui': 'C0452138', 'cui_str': 'Sensorineural hearing loss, bilateral (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009199', 'cui_str': 'Auditory Prosthesis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0231881', 'cui_str': 'Resonance, function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",20.0,0.0158725,"The cochlear implanted adults submitted to vocal rehabilitation presented changes in the auditory-perceptual parameters, with reduction of the overall voice severity, vocal instability, and degree of resonance after vocal intervention.","[{'ForeName': 'Maysa Tibério', 'Initials': 'MT', 'LastName': 'Ubrig', 'Affiliation': 'Division of Otorhinolaryngology, University of São Paulo Medical School, Brazil. Electronic address: maysaubrig@gmail.com.'}, {'ForeName': 'Robinson Koji', 'Initials': 'RK', 'LastName': 'Tsuji', 'Affiliation': 'Division of Otorhinolaryngology, University of São Paulo Medical School, Brazil.'}, {'ForeName': 'Raimar', 'Initials': 'R', 'LastName': 'Weber', 'Affiliation': 'Division of Otorhinolaryngology, University of São Paulo Medical School, Brazil.'}, {'ForeName': 'Márcia H Moreira', 'Initials': 'MHM', 'LastName': 'Menezes', 'Affiliation': 'Division of Otorhinolaryngology, University of São Paulo Medical School, Brazil.'}, {'ForeName': 'Viviane M O', 'Initials': 'VMO', 'LastName': 'Barrichelo', 'Affiliation': 'Division of Otorhinolaryngology, University of São Paulo Medical School, Brazil.'}, {'ForeName': 'Maria Gabriela B', 'Initials': 'MGB', 'LastName': 'da Cunha', 'Affiliation': 'Division of Otorhinolaryngology, University of São Paulo Medical School, Brazil.'}, {'ForeName': 'Domingos Hiroshi', 'Initials': 'DH', 'LastName': 'Tsuji', 'Affiliation': 'Division of Otorhinolaryngology, University of São Paulo Medical School, Brazil.'}, {'ForeName': 'Maria Valéria S', 'Initials': 'MVS', 'LastName': 'Goffi-Gomez', 'Affiliation': 'Division of Otorhinolaryngology, University of São Paulo Medical School, Brazil.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2018.07.004']
1067,30178727,Can brief alcohol interventions in general hospital inpatients improve mental and general health over 2 years? Results from a randomized controlled trial.,"BACKGROUND
Little is known about the impact of brief alcohol interventions on mental and general health. The aim was to investigate whether brief interventions for general hospital inpatients with at-risk drinking can improve mental and general health over 2 years; and whether effects are dependent on how they are delivered: in-person or through computer-generated feedback letters (CO).
METHODS
Three-arm randomized controlled trial with 6-, 12-, 18-, and 24-month follow-ups. Data were collected on 13 general hospital wards from four medical departments (internal medicine, surgical medicine, trauma surgery, and ear-nose-throat) of one university hospital in northeastern rural Germany. A consecutive sample of 961 18- to 64-year-old general hospital inpatients with at-risk alcohol use was recruited through systematic screening. Inpatients with particularly severe alcohol problems were excluded. Participants were allocated to: in-person counseling (PE), CO, and assessment only (AO). PE and CO included three contacts: on the ward, 1, and 3 months later. Mental and general health were assessed using the five-item mental health inventory (0-100) and a one-item general health measure (0, poor - 4, excellent).
RESULTS
Latent growth models including all participants revealed: after 24 months and in contrast to AO, mental and general health were improved in PE (change in mean difference, ΔMmental = 5.13, p = 0.002, Cohen's d = 0.51; ΔMgeneral = 0.20, p = 0.005, d = 0.71) and CO (ΔMmental = 6.98, p < 0.001, d = 0.69; ΔMgeneral = 0.24, p = 0.001, d = 0.86). PE and CO did not differ significantly.
CONCLUSIONS
Beyond drinking reduction, PE and CO can improve general hospital inpatients' self-reported mental and general health over 2 years.",2019,"PE and CO did not differ significantly.
","['13 general hospital wards from four medical departments (internal medicine, surgical medicine, trauma surgery, and ear-nose-throat) of one university hospital in northeastern rural Germany', '961 18- to 64-year-old general hospital inpatients with at-risk alcohol use was recruited through systematic screening', 'general hospital inpatients improve mental and general health over 2 years', 'general hospital inpatients with at-risk drinking can improve mental and general health over 2 years', 'Inpatients with particularly severe alcohol problems']","['Beyond drinking reduction', 'PE and CO', 'person counseling (PE), CO, and assessment only (AO', 'alcohol interventions']","['Mental and general health', 'PE and CO', 'AO, mental and general health']","[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0587450', 'cui_str': 'Medical department (environment)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C0230069', 'cui_str': 'Structure of anterior portion of neck'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",13.0,0.0842816,"PE and CO did not differ significantly.
","[{'ForeName': 'Jennis', 'Initials': 'J', 'LastName': 'Freyer-Adam', 'Affiliation': 'Institute for Medical Psychology, University Medicine Greifswald,Greifswald,Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'German Center for Cardiovascular Research,Site Greifswald,Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Haberecht', 'Affiliation': 'German Center for Cardiovascular Research,Site Greifswald,Germany.'}, {'ForeName': 'Gallus', 'Initials': 'G', 'LastName': 'Bischof', 'Affiliation': 'Department of Psychiatry and Psychotherapy,Medical University of Luebeck,Luebeck,Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'German Center for Cardiovascular Research,Site Greifswald,Germany.'}, {'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Rumpf', 'Affiliation': 'Department of Psychiatry and Psychotherapy,Medical University of Luebeck,Luebeck,Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'John', 'Affiliation': 'German Center for Cardiovascular Research,Site Greifswald,Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Gaertner', 'Affiliation': 'Department of Epidemiology and Health Monitoring,Robert Koch Institute Berlin,Berlin,Germany.'}]",Psychological medicine,['10.1017/S0033291718002453']
1068,30180918,The effects of combined oxytocin and cognitive behavioral social skills training on social cognition in schizophrenia.,"BACKGROUND
Individuals with schizophrenia have deficits in social cognition that are associated with poor functional outcome. Unfortunately, current treatments result in only modest improvement in social cognition. Oxytocin, a neuropeptide with pro-social effects, has significant benefits for social cognition in the general population. However, studies examining the efficacy of oxytocin in schizophrenia have yielded inconsistent results. One reason for inconsistency may be that oxytocin has typically not been combined with psychosocial interventions. It may be necessary for individuals with schizophrenia to receive concurrent psychosocial treatment while taking oxytocin to have the context needed to make gains in social cognitive skills.
METHODS
The current study tested this hypothesis in a 24-week (48 session) double-blind, placebo-controlled trial that combined oxytocin and Cognitive-Behavioral Social Skills Training (CBSST), which included elements from Social Cognition and Interaction Training (SCIT). Participants included 62 outpatients diagnosed with schizophrenia (placebo n = 31; oxytocin n = 31) who received 36 IU BID, with supervised administration 45 min prior to sessions on CBSST group therapy days. Participants completed a battery of measures administered at 0, 12, and 24 weeks that assessed social cognition.
RESULTS
CBSST generally failed to enhance social cognition from baseline to end of study, and there was no additive benefit of oxytocin beyond the effects of CBSST alone.
CONCLUSIONS
Findings suggest that combined CBSST and oxytocin had minimal benefit for social cognition, adding to the growing literature indicating null effects of oxytocin in multi-dose trials. Methodological and biological factors may contribute to inconsistent results across studies.",2019,"RESULTS
CBSST generally failed to enhance social cognition from baseline to end of study, and there was no additive benefit of oxytocin beyond the effects of CBSST alone.
","['schizophrenia', 'Participants included 62 outpatients diagnosed with schizophrenia (placebo n = 31; oxytocin n = 31', 'individuals with schizophrenia']","['combined oxytocin and Cognitive-Behavioral Social Skills Training (CBSST), which included elements from Social Cognition and Interaction Training (SCIT', 'placebo', 'combined oxytocin and cognitive behavioral social skills training', 'Oxytocin', 'CBSST and oxytocin', 'oxytocin']",['social cognition'],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",62.0,0.0244618,"RESULTS
CBSST generally failed to enhance social cognition from baseline to end of study, and there was no additive benefit of oxytocin beyond the effects of CBSST alone.
","[{'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology,University of Georgia,Athens, GA,USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Granholm', 'Affiliation': 'VA San Diego Healthcare System, Department of Psychiatry,University of California San Diego School of Medicine,San Diego, CA,USA.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Holden', 'Affiliation': 'VA San Diego Healthcare System, Department of Psychiatry,University of California San Diego School of Medicine,San Diego, CA,USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Ruiz', 'Affiliation': 'Department of Psychology,University of Georgia,Athens, GA,USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': 'Department of Psychiatry,Maryland Psychiatric Research Center, University of Maryland School of Medicine,Baltimore, MD,USA.'}, {'ForeName': 'Deanna L', 'Initials': 'DL', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry,Maryland Psychiatric Research Center, University of Maryland School of Medicine,Baltimore, MD,USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'Department of Psychiatry,Maryland Psychiatric Research Center, University of Maryland School of Medicine,Baltimore, MD,USA.'}]",Psychological medicine,['10.1017/S0033291718002465']
1069,31264766,Novel shampoo reduces hair shedding by contracting the arrector pili muscle via the trace amine-associated receptor.,"BACKGROUND
Approximately 40% of women experience excessive hair shedding when washing their hair. Previously, we have demonstrated that a topically applied α1 adrenergic receptor agonist can be used to contract the arrector pili muscle of the follicular unit (ie, produce ""goose bumps""), increasing the force required to pluck hair by as much as 400%. Subsequently, we reported a topical cosmetic solution containing an α1 adrenergic receptor agonist that reduced hair shedding during brushing by a maximum of 77%.
AIMS
In this communication, we explore a novel mechanism to contract the arrector pili muscle. Trace amine-associated receptors (TAAR) have been shown to regulate smooth muscle tone in blood vessels, but have not been reported to be present in the skin. Here, we report on the anti-shedding efficacy of a shampoo containing a selective TAAR agonist, tyramine hydrochloride.
METHODS
A single-blinded crossover study was designed to test the efficacy of the novel shampoo versus placebo in reducing hairs lost during brushing.
RESULTS
In this study, the novel TAAR shampoo reduced hair shedding during brushing by 31% in a cohort of 24 women with a maximum reduction of 77%.
CONCLUSIONS
A shampoo formulated with a selective TAAR agonist was demonstrated to contract the arrector pili muscle and reduce hair shedding subsequent to washing.",2019,"In this study, the novel TAAR shampoo reduced hair shedding during brushing by 31% in a cohort of 24 women with a maximum reduction of 77%.
",['hairs lost during brushing'],"['shampoo containing a selective TAAR agonist, tyramine hydrochloride', 'novel shampoo versus placebo']",['hair shedding'],"[{'cui': 'C0018494', 'cui_str': 'Hair'}]","[{'cui': 'C1554936', 'cui_str': 'Shampoo - dosing instruction imperative'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0041479', 'cui_str': 'Tyramine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018494', 'cui_str': 'Hair'}]",24.0,0.0394428,"In this study, the novel TAAR shampoo reduced hair shedding during brushing by 31% in a cohort of 24 women with a maximum reduction of 77%.
","[{'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Kovacevic', 'Affiliation': 'Department of Dermatology and Venereology, University Hospital Center ""Sestre milosrdnice"", Zagreb, Croatia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McCoy', 'Affiliation': 'Applied Biology, Irvine, California, USA.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Goren', 'Affiliation': 'Department of Dermatology and Venereology, University Hospital Center ""Sestre milosrdnice"", Zagreb, Croatia.'}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Situm', 'Affiliation': 'Department of Dermatology and Venereology, University Hospital Center ""Sestre milosrdnice"", Zagreb, Croatia.'}, {'ForeName': 'Andrija', 'Initials': 'A', 'LastName': 'Stanimirovic', 'Affiliation': 'Department of Clinical Medicine, University of Applied Health Sciences, Zagreb, Croatia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'General Hospital of Air Force, PLA, Beijing, China.'}, {'ForeName': 'Yimei', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Skin & Cosmetic Research Department, Shanghai Skin Disease Hospital, Shanghai, China.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Vaño-Galvan', 'Affiliation': 'Trichology Unit, Dermatology Department, Ramon y Cajal Hospital, IRYCIS, University of Alcala, Madrid, Spain.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Department of Dermatology, New York University Langone Medical Center, New York, New York, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Sinclair', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13054']
1070,31258108,Short-term impact of sucralose consumption on the metabolic response and gut microbiome of healthy adults.,"Sucralose is an artificial non-nutritive sweetener used in foods aimed to reduce sugar and energy intake. While thought to be inert, the impact of sucralose on metabolic control has shown to be the opposite. The gut microbiome has emerged as a factor shaping metabolic responses after sweetener consumption. We examined the short-term effect of sucralose consumption on glucose homeostasis and gut microbiome of healthy male volunteers. We performed a randomised, double-blind study in thirty-four subjects divided into two groups, one that was administered sucralose capsules (780 mg/d for 7 d; n 17) and a control group receiving placebo (n 17). Before and after the intervention, glycaemic and insulinaemic responses were assessed with a standard oral glucose load (75 g). Insulin resistance was determined using homeostasis model assessment of insulin resistance and Matsuda indexes. The gut microbiome was evaluated before and after the intervention by 16S rRNA sequencing. During the study, body weight remained constant in both groups. Glycaemic control and insulin resistance were not affected during the 7-d period. At the phylum level, gut microbiome was not modified in any group. We classified subjects according to their change in insulinaemia after the intervention, to compare the microbiome of responders and non-responders. Independent of consuming sucralose or placebo, individuals with a higher insulinaemic response after the intervention had lower Bacteroidetes and higher Firmicutes abundances. In conclusion, consumption of high doses of sucralose for 7 d does not alter glycaemic control, insulin resistance, or gut microbiome in healthy individuals. However, it highlights the need to address individual responses to sucralose.",2019,"Independent of consuming sucralose or placebo, individuals with a higher insulinemic response after the intervention had lower Bacteroidetes and higher Firmicutes abundances.","['34 subjects divided into two groups', 'healthy individuals', 'Healthy Adults', 'healthy male volunteers']","['placebo', 'control group receiving placebo', 'sucralose consumption', 'Sucralose Consumption', 'sucralose capsules']","['glycemic and insulinemic responses', 'Insulin resistance', 'Glycemic control and insulin resistance', 'glucose homeostasis', 'glycemic control, insulin resistance, or gut microbiome', 'Metabolic Response and Gut Microbiome']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",34.0,0.0395037,"Independent of consuming sucralose or placebo, individuals with a higher insulinemic response after the intervention had lower Bacteroidetes and higher Firmicutes abundances.","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Thomson', 'Affiliation': 'Department of Chemical and Bioprocess Engineering, School of Engineering, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Santibañez', 'Affiliation': 'Department of Chemical and Bioprocess Engineering, School of Engineering, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Aguirre', 'Affiliation': 'Departamento Ciencias de la Salud, Carrera de Nutrición y Dietética, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Jose E', 'Initials': 'JE', 'LastName': 'Galgani', 'Affiliation': 'Departamento Ciencias de la Salud, Carrera de Nutrición y Dietética, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Garrido', 'Affiliation': 'Department of Chemical and Bioprocess Engineering, School of Engineering, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",The British journal of nutrition,['10.1017/S0007114519001570']
1071,31276178,Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial.,"Importance
Colorectal cancer screening rates are suboptimal, particularly among sociodemographically disadvantaged groups.
Objective
To examine whether guaranteed money or probabilistic lottery financial incentives conditional on completion of colorectal cancer screening increase screening uptake, particularly among groups with lower screening rates.
Design, Setting, and Participants
This parallel, 3-arm randomized clinical trial was conducted from March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington. A total of 838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled.
Interventions
Interventions were (1) mail only (n = 284; up to 3 mailings that included information on the importance of colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n = 270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n = 284; mailings plus a 1 in 10 chance of receiving $50 on screening completion).
Main Outcomes and Measures
The primary outcome was completion of any colorectal cancer screening within 6 months of randomization. Secondary outcomes were FIT or colonoscopy completion within 6 months of randomization. Intervention effects were compared across sociodemographic subgroups and self-reported psychosocial measures.
Results
A total of 838 participants (mean [SD] age, 59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity) were included in the study. Completion of any colorectal screening was not significantly higher for the mail and monetary group (207 of 270 [76.7%]) or the mail and lottery group (212 of 284 [74.6%]) than for the mail only group (203 of 284 [71.5%]) (P = .11). For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group. For patients with Medicaid insurance, the net increase compared with mail only in FIT completion for the mail and monetary or the mail and lottery group was 37.7% (95% CI, 11.0%-64.3%) (34.2% for the mail and monetary group and 40.4% for the mail and lottery group) compared with a net increase of only 5.6% (95% CI, -0.9% to 12.2%) among those not Medicaid insured (test for interaction P = .03).
Conclusions and Relevance
Financial incentives increased FIT uptake but not overall colorectal cancer screening. Financial incentives may decrease screening disparities among some sociodemographically disadvantaged groups.
Trial Registration
ClinicalTrials.gov identifier: NCT00697047.",2019,"For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group.","['59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity', 'March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington', '838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled', '838 participants (mean [SD] age']","['colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n\u2009=\u2009270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n\u2009=\u2009284; mailings plus a 1 in 10 chance of receiving $50 on screening completion']","['completion of any colorectal cancer screening', 'Colorectal Cancer Screening Uptake and Decrease Disparities', 'FIT completion', 'Completion of any colorectal screening', 'FIT or colonoscopy completion']","[{'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517801', 'cui_str': '52.2 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0282599', 'cui_str': 'Integrated Health Care Systems'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",838.0,0.172407,"For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group.","[{'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington, Seattle.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Cook', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chubak', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Fuller', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Kilian J', 'Initials': 'KJ', 'LastName': 'Kimbel', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Kullgren', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Meenan', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Department of Health Promotion and Behavior Sciences, University of Texas School of Public Health, Houston.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.6570']
1072,30362878,Kinematic and Neuromuscular Adaptations in Incomplete Spinal Cord Injury after High- versus Low-Intensity Locomotor Training.,"Recent data demonstrate improved locomotion with high-intensity locomotor training (LT) in individuals with incomplete spinal cord injury (iSCI), although concerns remain regarding reinforcement of abnormal motor strategies. The present study evaluated the effects of LT intensity on kinematic and neuromuscular coordination in individuals with iSCI. Using a randomized, crossover design, participants with iSCI received up to 20 sessions of high-intensity LT, with attempts to achieve 70-85% of age-predicted maximum heart rate (HRmax), or low-intensity LT (50-65% HRmax), following which the other intervention was performed. Specific measures included spatiotemporal variables, sagittal-plane gait kinematics, and neuromuscular synergies from electromyographic (EMG) recordings. Correlation analyses were conducted to evaluate associations between variables. Significant improvements in sagittal-plane joint excursions and intralimb hip-knee coordination were observed following high- but not low-intensity LT when comparing peak treadmill (TM) speed before and after LT. Neuromuscular complexity (i.e., number of synergies to explain >90% of EMG variance) was also increased following high- but not low-intensity LT. Comparison of speed-matched trials confirmed significant improvements in the knee excursion of the less impaired limb and intralimb hip-knee coordination, as well as improvements in neuromuscular complexity following high-intensity LT. These findings suggest greater neuromuscular complexity may be due to LT and not necessarily differences in speeds. Only selected kinematic changes (i.e., weak hip excursion) was correlated to improvements in treadmill speed. In conclusion, LT intensity can facilitate gains in kinematic variables and neuromuscular synergies in individuals with iSCI.",2019,"Comparison of speed-matched trials confirmed significant improvements in the knee excursion of the less impaired limb and intralimb hip-knee coordination, as well as improvements in neuromuscular complexity following high-intensity LT.","['individuals with incomplete spinal cord injury (iSCI', 'individuals with iSCI', 'participants with iSCI']","['intensity locomotor training (LT', 'High- versus Low-Intensity Locomotor Training']","['treadmill speed', 'neuromuscular complexity', 'sagittal-plane joint excursions and intralimb hip-knee coordination', 'spatiotemporal variables, sagittal-plane gait kinematics, and neuromuscular synergies from electromyographic (EMG) recordings', 'Neuromuscular complexity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",,0.058473,"Comparison of speed-matched trials confirmed significant improvements in the knee excursion of the less impaired limb and intralimb hip-knee coordination, as well as improvements in neuromuscular complexity following high-intensity LT.","[{'ForeName': 'Marzieh M', 'Initials': 'MM', 'LastName': 'Ardestani', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Seyed H', 'Initials': 'SH', 'LastName': 'Salehi', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Gordhan B', 'Initials': 'GB', 'LastName': 'Mahtani', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': '2 Department of Physical Medicine and Rehabilitation, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}]",Journal of neurotrauma,['10.1089/neu.2018.5900']
1073,32409485,Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures.,"OBJECTIVE
To evaluate the efficacy and safety of adjunctive cenobamate 200 mg/d in patients with uncontrolled focal (partial-onset) seizures despite treatment with 1 to 3 antiepileptic drugs.
METHODS
In this multicenter, double-blind, placebo-controlled study, adults 18 to 65 years of age with focal seizures were randomized 1:1 (cenobamate:placebo) after an 8-week baseline period. The 12-week double-blind treatment period consisted of a 6-week titration phase and a 6-week maintenance phase. The primary outcome was percent change in seizure frequency (from baseline) per 28 days during double-blind treatment.
RESULTS
Two hundred twenty-two patients were randomized; 113 received cenobamate and 109 received placebo; and 90.3% and 90.8% of patients, respectively, completed double-blind treatment. Median baseline seizure frequency was 6.5 in 28 days (range 0-237). Compared to placebo, cenobamate conferred a greater median percent seizure reduction (55.6% vs 21.5%; p < 0.0001) The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo ( p < 0.0001). Focal seizures with motor component, impaired awareness, and focal to bilateral tonic-clonic seizures were significantly reduced with cenobamate vs placebo. During maintenance, 28.3% of cenobamate-treated and 8.8% of placebo-treated patients were seizure-free. Treatment-emergent adverse events reported in >10% in either group (cenobamate vs placebo) were somnolence (22.1% vs 11.9%), dizziness (22.1% vs 16.5%), headache (12.4% vs 12.8%), nausea (11.5% vs 4.6%), and fatigue (10.6% vs 6.4%).
CONCLUSION
Adjunctive treatment with cenobamate 200 mg/d significantly improved seizure control in adults with uncontrolled focal seizures and was well tolerated.
CLINICALTRIALSGOV IDENTIFIER
NCT01397968.
CLASSIFICATION OF EVIDENCE
This study provides Class I evidence that, for patients with uncontrolled focal seizures, adjunctive cenobamate reduces seizures.",2020,The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo ( p < 0.0001).,"['patients with uncontrolled focal seizures', 'adults 18 to 65 years of age with focal seizures', 'Two hundred twenty-two patients were randomized; 113 received', 'patients with uncontrolled focal (partial-onset) seizures despite treatment with 1 to 3 antiepileptic drugs', 'patients with uncontrolled focal seizures, adjunctive cenobamate reduces seizures']","['adjunctive cenobamate', 'cenobamate vs placebo', 'cenobamate', 'placebo']","['headache', 'Median baseline seizure frequency', 'dizziness', 'responder rate', 'fatigue', 'seizure-free', 'efficacy and safety', 'somnolence', 'Focal seizures with motor component, impaired awareness, and focal to bilateral tonic-clonic seizures', 'nausea', 'percent change in seizure frequency', 'median percent seizure reduction', 'seizure control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",222.0,0.791106,The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo ( p < 0.0001).,"[{'ForeName': 'Steve S', 'Initials': 'SS', 'LastName': 'Chung', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ. steve.chung@bannerhealth.com.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'French', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kowalski', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Maciejowski', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Sperling', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mizne', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kamin', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}]",Neurology,['10.1212/WNL.0000000000009530']
1074,30998063,The modifying effects of social support on psychological outcomes in patients with heart failure.,"OBJECTIVE
We examined the modifying effects of social support on depressive symptoms and health-related quality of life (QoL) in patients receiving coping skills training (CST).
METHOD
We considered the modifying effects of social support in the Coping Effectively with Heart Failure clinical trial, which randomized 179 heart failure (HF) patients to either 4 months of CST or usual care enhanced by HF education (HFE). CST involved training in specific coping techniques, whereas HFE involved education about HF self-management. Social support was assessed by the Enhancing Recovery in Coronary Heart Disease (ENRICHD) Social Support Inventory, QoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), and depression was assessed with the Beck Depression Inventory-II (BDI-II).
RESULTS
Linear regression models revealed a significant Intervention Group × Baseline Social Support interaction for change in KCCQ total scores (p = .006) and BDI-II scores (p < .001). Participants with low social support assigned to the CST intervention showed large improvements in KCCQ scores (M = 11.2, 95% CI [5.7, 16.8]), whereas low-social-support patients assigned to the HFE controls showed no significant change (M = -0.8, 95% CI [-7.2, 5.6]). Similarly, BDI-II scores in participants with low social support in the CST group showed large reductions (M = -8.7, 95% CI [-11.3, -6.1]) compared with low-social-support HFE participants (M = -3.0, 95% CI [-6.0, -0.1]).
CONCLUSIONS
HF patients with low social support benefit substantially from telephone-based CST interventions. Targeting HF patients with low social support for behavioral interventions could prove to be a cost-effective strategy for improving QoL and reducing depression. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Participants with low social support assigned to the CST intervention showed large improvements in KCCQ scores (M = 11.2, 95% CI [5.7, 16.8]), whereas low-social-support patients assigned to the HFE controls showed no significant change (M = -0.8, 95% CI [-7.2, 5.6]).","['patients receiving coping skills training (CST', '179 heart failure (HF) patients to either 4 months of', 'patients with heart failure']","['CST', 'CST intervention', 'social support', 'CST or usual care enhanced by HF education (HFE']","['Coronary Heart Disease (ENRICHD', 'psychological outcomes', 'KCCQ total scores', 'BDI-II scores', 'Kansas City Cardiomyopathy Questionnaire (KCCQ), and depression', 'KCCQ scores', 'depressive symptoms and health-related quality of life (QoL', 'Beck Depression Inventory-II (BDI-II']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training (procedure)'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0037438'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",179.0,0.052609,"Participants with low social support assigned to the CST intervention showed large improvements in KCCQ scores (M = 11.2, 95% CI [5.7, 16.8]), whereas low-social-support patients assigned to the HFE controls showed no significant change (M = -0.8, 95% CI [-7.2, 5.6]).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Yidan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Koch', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Lana L', 'Initials': 'LL', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Hinderliter', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Benson M', 'Initials': 'BM', 'LastName': 'Hoffman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Rogers', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Patricia P', 'Initials': 'PP', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Kristy S', 'Initials': 'KS', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sherwood', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000716']
1075,30978155,Intermittent Versus Continuous PEG-Asparaginase to Reduce Asparaginase-Associated Toxicities: A NOPHO ALL2008 Randomized Study.,"PURPOSE
Asparaginase is an essential drug in childhood acute lymphoblastic leukemia (ALL) therapy and is frequently given for months to obtain continuous asparagine depletion. We randomly assigned patients to continuous versus intermittent pegylated-asparaginase (PEG-asp) treatment, hypothesizing there would be decreased toxicity with unchanged efficacy.
METHODS
Children (median age, 4.2 years) treated for non-high-risk ALL according to the Nordic Society for Pediatric Hematology and Oncology ALL2008 protocol received five intramuscular PEG-asp injections (1,000 IU/m 2 ) every two weeks and were then randomly assigned to additional three doses (6-week intervals [experimental arm], n = 309) versus 10 doses (2-week intervals [standard arm], n = 316). The primary end point was noninferior (6% margin) disease-free survival. Toxicity reduction was a secondary end point. Occurrence of asparaginase-associated hypersensitivity, pancreatitis, osteonecrosis, and thromboembolism were prospectively registered.
RESULTS
After a median follow-up of 4.1 years, the 5-year disease-free survival was 92.2% (95% CI, 88.6 to 95.8) and 90.8% (95% CI, 87.0 to 94.6) in the experimental and standard arms, respectively. The 3-year cumulative incidence of any first asparaginase-associated toxicity (hypersensitivity [n = 13]; osteonecrosis [n = 29]; pancreatitis [n = 24]; thromboembolism [n = 17]) was 9.3% in the experimental arm and 18.1% in the standard arm ( P = .001). Asparaginase-associated toxicity reduction was confirmed in sex- and risk-group-adjusted Cox regression analysis stratified by age (≥ 10 and < 10 years; hazard ratio, 0.48; P = .001). The experimental arm had the lowest incidences of all four toxicities, reaching significance for pancreatitis (6-month risk, 5.8% v 1.3%; P = .002).
CONCLUSION
The excellent cure rates and reduced toxicity risk support the use of intermittent PEG-asp therapy after the first 10 weeks in future childhood ALL trials that apply prolonged PEG-asp therapy.",2019,"The experimental arm had the lowest incidences of all four toxicities, reaching significance for pancreatitis (6-month risk, 5.8% v 1.3%; P = .002).
","['Children (median age, 4.2 years) treated for non-high-risk ALL according to the Nordic Society for Pediatric Hematology and Oncology ALL2008 protocol received five', 'childhood acute lymphoblastic leukemia (ALL']","['intramuscular PEG-asp injections', 'Intermittent Versus Continuous PEG-Asparaginase', 'continuous versus intermittent pegylated-asparaginase (PEG-asp']","['Toxicity reduction', '5-year disease-free survival', '3-year cumulative incidence of any first asparaginase-associated toxicity', 'excellent cure rates and reduced toxicity risk', 'Asparaginase-Associated Toxicities', 'noninferior (6% margin) disease-free survival', 'toxicity with unchanged efficacy', 'Occurrence of asparaginase-associated hypersensitivity, pancreatitis, osteonecrosis, and thromboembolism', 'toxicity reduction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1690538', 'cui_str': 'Pediatric hematology'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0647096', 'cui_str': 'monomethoxypolyethylene glycol-conjugated asparaginase'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}]",,0.0888222,"The experimental arm had the lowest incidences of all four toxicities, reaching significance for pancreatitis (6-month risk, 5.8% v 1.3%; P = .002).
","[{'ForeName': 'Birgitte Klug', 'Initials': 'BK', 'LastName': 'Albertsen', 'Affiliation': '1 Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Grell', 'Affiliation': '2 University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Abrahamsson', 'Affiliation': '4 University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bendik', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': '5 Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Vettenranta', 'Affiliation': '6 Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Ólafur G', 'Initials': 'ÓG', 'LastName': 'Jónsson', 'Affiliation': '7 Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Frandsen', 'Affiliation': '3 Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Benjamin O', 'Initials': 'BO', 'LastName': 'Wolthers', 'Affiliation': '3 Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Heyman', 'Affiliation': '8 Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Schmiegelow', 'Affiliation': '2 University of Copenhagen, Copenhagen, Denmark.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01877']
1076,30969147,Trauma-Informed Personalized Scripts to Address Partner Violence and Reproductive Coercion: Preliminary Findings from an Implementation Randomized Controlled Trial.,"Background: Family planning (FP) providers are in an optimal position to address harmful partner behaviors, yet face several barriers. We assessed the effectiveness of an interactive app to facilitate implementation of patient-provider discussions about intimate partner violence (IPV), reproductive coercion (RC), a wallet-sized educational card, and sexually transmitted infections (STIs). Materials and Methods: We randomized participants (English-speaking females, ages 16-29 years) from four FP clinics to two arms: Trauma-Informed Personalized Scripts (TIPS)-Plus and TIPS-Basic. We developed an app that prompted (1) tailored provider scripts (TIPS-Plus and TIPS-Basic) and (2) psychoeducational messages for patients (TIPS-Plus only). Patients completed pre- and postvisit surveys. We compared mean summary scores of IPV, RC, card, and STI discussions between TIPS-Plus and TIPS-Basic using Wilcoxon rank-sum tests, explored predictors with ordinal regression, and compared implementation with historical data using chi-square. Results: Of the 240 participants, 47.5% reported lifetime IPV, 12.5% recent IPV, and 7.1% recent RC. No statistically significant differences emerged from summary scores between arms for any outcomes. Several significant predictors were associated with higher scores for patient-provider discussions, including race, reason for visit, contraceptive method, and condom nonuse. Implementation of IPV, RC, and STI discussions increased significantly ( p < 0.0001) when compared with historical clinical data for both TIPS-Basic and TIPS-Plus. Conclusions: We did not find an added benefit of patient activation messages in increasing frequency of sensitive discussions. Several patient characteristics appear to influence providers' likelihood of conversations about harmful partner behaviors. Compared with prior data, this pilot study suggests potential benefits of using provider scripts to guide discussions.",2019,"Implementation of IPV, RC, and STI discussions increased significantly ( p < 0.0001) when compared with historical clinical data for both TIPS-Basic and TIPS-Plus. ","['participants (English-speaking females, ages 16-29 years) from four FP clinics to two arms']","[': Family planning (FP', 'Trauma-Informed Personalized Scripts (TIPS)-Plus and TIPS-Basic']","['Implementation of IPV, RC, and STI discussions', 'lifetime IPV', 'mean summary scores of IPV, RC, card, and STI discussions between TIPS-Plus and TIPS-Basic using Wilcoxon rank-sum tests']","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0009861', 'cui_str': 'Family Planning Services'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0242928', 'cui_str': 'Rank-Sum Tests'}]",240.0,0.0980201,"Implementation of IPV, RC, and STI discussions increased significantly ( p < 0.0001) when compared with historical clinical data for both TIPS-Basic and TIPS-Plus. ","[{'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Hill', 'Affiliation': ""1 Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Zachor', 'Affiliation': '2 Department of Obstetrics and Gynecology, The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""1 Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Talis', 'Affiliation': ""1 Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Zelazny', 'Affiliation': '3 Allegheny Health Network Trauma Centers, Allegheny Health Network, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""1 Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}]",Journal of women's health (2002),['10.1089/jwh.2018.7318']
1077,31795162,Comparison of the Acute Postprandial Circulating B-Vitamin and Vitamer Responses to Single Breakfast Meals in Young and Older Individuals: Preliminary Secondary Outcomes of a Randomized Controlled Trial.,"B-vitamin deficiency is common in ageing populations either due to altered dietary habits or altered digestive and metabolic functions. There is limited data on the acute circulating concentrations of B-vitamins and their various forms (vitamers), following ingestion of realistic meals. This study compared the acute circulating B-vitamin and vitamer responses to either an energy-dense (ED) or a nutrient-dense (ND) breakfast meal, consumed in a randomized cross-over sequence, in older and younger adults ( n = 15 and 15, aged 67.3 ± 1.5 and 22.7 ± 0.5 years (mean ± SEM), respectively). Eleven differing B-vitamins and vitamers were determined in plasma samples by ultra-high-performance liquid chromatography-tandem mass spectrometry, in the fasting and postprandial state (hourly for 5 h). While postprandial thiamine concentration increased following both meals, riboflavin increased only following a ND meal in both age groups. Many vitamins including nicotinic acid, pantothenic acid, pyridoxal, pyridoxamine, pyridoxal-5'phosphate, and 4-pyridoxic acid remained unaltered, and flavin mononucleotide (FMN), nicotinamide and nicotinuric acid concentrations reduced following both meals. Biological age and food composition had minimal impact on postprandial B-vitamin concentrations, yet the differences between the ED and ND meals for riboflavin highlight the importance of riboflavin intake to achieve adequacy.",2019,"While postprandial thiamine concentration increased following both meals, riboflavin increased only following a ND meal in both age groups.","['Young and Older Individuals', 'older and younger adults ( n = 15 and 15, aged 67.3 ± 1.5 and 22.7 ± 0.5 years (mean ± SEM), respectively']","['Acute Postprandial Circulating B-Vitamin and Vitamer Responses to Single Breakfast Meals', 'riboflavin', 'energy-dense (ED) or a nutrient-dense (ND) breakfast meal']","['postprandial thiamine concentration', 'postprandial B-vitamin concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0373720', 'cui_str': 'Vitamin B2'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}]",11.0,0.12452,"While postprandial thiamine concentration increased following both meals, riboflavin increased only following a ND meal in both age groups.","[{'ForeName': 'Pankaja', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gillies', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Pundir', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'Chantal A', 'Initials': 'CA', 'LastName': 'Pileggi', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Markworth', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Thorstensen', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland 1023, New Zealand.'}]",Nutrients,['10.3390/nu11122893']
1078,31688331,Preventive effect of dexmedetomidine on postictal delirium after electroconvulsive therapy: A randomised controlled study.,"BACKGROUND
Postictal delirium (PID) is a relatively common complication following electroconvulsive therapy (ECT).
OBJECTIVE
We investigated whether prophylactic dexmedetomidine administration would safely decrease the incidence of PID in psychiatric patients after ECT.
DESIGN
A randomised, double-blind, placebo-controlled trial.
PATIENTS
A total of 223 patients undergoing ECT were randomly allocated to two groups.
INTERVENTIONS
Patients received 0.5 μg kg dexmedetomidine (Dex group, n=111) or 0.9% sodium chloride (Con group, n=112) before ECT. Propofol was used for anaesthesia and succinylcholine for muscle relaxation. The incidence of PID was measured using the Confusion Assessment Method for the Intensive Care Unit.
MAIN OUTCOME MEASURES
The percentage of patients who were diagnosed with PID at any ECT session during the whole treatment.
RESULTS
PID occurred in 76 (67.9%) of 112 patients given saline (0.9% sodium chloride), and in 49 (44.1%) of 111 patients given dexmedetomidine during the whole treatment. There was a significant difference in the incidence of PID between two groups (P < 0.001). Post hoc analyses showed that the incidence of PID was significantly lower in the Dex group than in the Con group from the first to the seventh ECT session (P < 0.005). There were no significant differences in seizure duration or recovery time between the two groups. Heart rate and mean arterial pressure in the Dex group were significantly lower than in the Con group at 0, 5 and 15 min after electrical stimulation. No patients developed bradycardia, hypotension or respiratory depression during recovery.
CONCLUSION
Pretreatment with dexmedetomidine leads to a significant reduction in the incidence of PID with no respiratory depressant effect. Dexmedetomidine might be considered an effective method for the prevention of PID post-ECT.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR-IOR-17012306.",2020,"Heart rate and mean arterial pressure in the Dex group were significantly lower than in the Con group at 0, 5 and 15 min after electrical stimulation.","['psychiatric patients after ECT', '223 patients undergoing ECT']","['dexmedetomidine (Dex group, n=111) or 0.9% sodium chloride (Con group, n=112) before ECT', 'dexmedetomidine', 'prophylactic dexmedetomidine', 'Dexmedetomidine', 'electroconvulsive therapy (ECT', 'placebo', 'succinylcholine', 'Dex', 'Propofol', 'electroconvulsive therapy']","['incidence of PID', 'seizure duration or recovery time', 'PID', 'Heart rate and mean arterial pressure', 'postictal delirium', 'bradycardia, hypotension or respiratory depression']","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0234545', 'cui_str': 'Postseizure delirium'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}]",223.0,0.275714,"Heart rate and mean arterial pressure in the Dex group were significantly lower than in the Con group at 0, 5 and 15 min after electrical stimulation.","[{'ForeName': 'Zhuolin', 'Initials': 'Z', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Shaoli', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Pinjie', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Xiang', 'Affiliation': ''}, {'ForeName': 'Ziqing', 'Initials': 'Z', 'LastName': 'Hei', 'Affiliation': ''}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001113']
1079,31263517,Reduction of the Self-Reference Effect in Younger and Older Adults.,"Relating information to the self improves memory. However, this self-reference effect (SRE) is typically studied through explicit self-judgments on individual trials. The current study assessed whether a self-referential mode of thought, induced through a writing task, also induced an SRE on a later task. The study also tested the effects of aging on the SRE, given that a long-lasting mnemonic strategy may be especially relevant for this group. Ninety-two younger adults and 60 older adults were assigned to different writing conditions and then completed an unrelated SRE task. Across younger and older adults, the classic SRE effect was observed in the narrative writing condition, reduced in the semantic self-reference condition, and further reduced in the episodic self-reference condition. These results support the induction of a self-referential mode of thought, but this mode does not enhance memory. The classic SRE effect can be reduced after thinking about the self by reflecting on autobiographical memories. Results argue for a single shared self-referential mechanism that can be accessed through self-focused writing or the classic SRE task.",2019,"Across younger and older adults, the classic SRE effect was observed in the narrative writing condition, reduced in the semantic self-reference condition, and further reduced in the episodic self-reference condition.","['Younger and Older Adults', 'Ninety-two younger adults and 60 older adults']",[],['classic SRE effect'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",92.0,0.0239585,"Across younger and older adults, the classic SRE effect was observed in the narrative writing condition, reduced in the semantic self-reference condition, and further reduced in the episodic self-reference condition.","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Jackson', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, MA, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Luu', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, MA, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Vigderman', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, MA, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Leshikar', 'Affiliation': 'Department of Psychology, University of Illinois - Chicago, Chicago, IL, USA.'}, {'ForeName': 'Peggy L', 'Initials': 'PL', 'LastName': 'St Jacques', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gutchess', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, MA, USA.'}]",Psychology & neuroscience,['10.1037/pne0000142']
1080,31804108,Randomized clinical trial of capnometry-assisted respiratory training in veterans with posttraumatic stress disorder hyperarousal.,"OBJECTIVE
To investigate whether capnometry-assisted antihyperventilation respiratory training, successful in treating panic, and sleep hygiene instructions would reduce posttraumatic stress disorder (PTSD) hyperarousal symptoms in U.S. military veterans.
METHOD
We conducted a parallel, nonblinded clinical trial and randomized 80 veterans with PTSD hyperarousal into treatment or wait list. Primary treatment outcomes from baseline to 1st follow-up were analyzed using mixed modeling. Baseline physiological measures were compared between the PTSD hyperarousal group and a no-PTSD group ( n = 68).
RESULTS
Baseline respiration rate but not partial-pressure of end-tidal carbon dioxide (PCO₂) was higher in the PTSD hyperarousal group than in the no-PTSD group during 3 min of quiet sitting, indicating no difference in baseline hyperventilation. There was no significant effect of the intervention on PTSD hyperarousal symptoms or hyperventilation compared to wait list, but treatment did lower respiratory rate.
CONCLUSION
This intervention did not reduce PTSD hyperarousal symptoms, perhaps due to differences between underlying mechanisms of PTSD hyperarousal and panic disorder or to differences between veteran and civilian populations. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"There was no significant effect of the intervention on PTSD hyperarousal symptoms or hyperventilation compared to wait list, but treatment did lower respiratory rate.
","['veterans with posttraumatic stress disorder hyperarousal', '80 veterans with PTSD hyperarousal into treatment or wait list', 'U.S. military veterans']","['capnometry-assisted antihyperventilation respiratory training', 'capnometry-assisted respiratory training']","['posttraumatic stress disorder (PTSD) hyperarousal symptoms', 'partial-pressure of end-tidal carbon dioxide (PCO₂', 'PTSD hyperarousal symptoms or hyperventilation', 'PTSD hyperarousal symptoms', 'baseline hyperventilation']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}]",80.0,0.0282812,"There was no significant effect of the intervention on PTSD hyperarousal symptoms or hyperventilation compared to wait list, but treatment did lower respiratory rate.
","[{'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Jamison', 'Affiliation': 'National Center for PTSD.'}, {'ForeName': 'Cindie', 'Initials': 'C', 'LastName': 'Slightam', 'Affiliation': 'National Center for PTSD.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Bertram', 'Affiliation': 'Temple University-Japan Campus.'}, {'ForeName': 'Sunyoung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Walton T', 'Initials': 'WT', 'LastName': 'Roth', 'Affiliation': 'VA Palo Alto Health Care System.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000525']
1081,31254596,Obeticholic acid may increase the risk of gallstone formation in susceptible patients.,"BACKGROUND & AIMS
The nuclear farnesoid X receptor (FXR) agonist obeticholic acid (OCA) has been developed for the treatment of liver diseases. We aimed to determine whether OCA treatment increases the risk of gallstone formation.
METHODS
Twenty patients awaiting laparoscopic cholecystectomy were randomized to treatment with OCA (25 mg/day) or placebo for 3 weeks until the day before surgery. Serum bile acids (BAs), the BA synthesis marker C4 (7α-hydroxy-4-cholesten-3-one), and fibroblast growth factor 19 (FGF19) were measured before and after treatment. During surgery, biopsies from the liver and the whole bile-filled gallbladder were collected for analyses of gene expression, biliary lipids and FGF19.
RESULTS
In serum, OCA increased FGF19 (from 95.0 ± 8.5 to 234.4 ± 35.6 ng/L) and decreased C4 (from 31.4 ± 22.8 to 2.8 ± 4.0 nmol/L) and endogenous BAs (from 1,312.2 ± 236.2 to 517.7 ± 178.9 nmol/L; all p <0.05). At surgery, BAs in gallbladder bile were lower in patients that received OCA than in controls (OCA, 77.9 ± 53.6 mmol/L; placebo, 196.4 ± 99.3 mmol/L; p <0.01), resulting in a higher cholesterol saturation index (OCA, 2.8 ± 1.1; placebo, 1.8 ± 0.8; p <0.05). In addition, hydrophobic OCA conjugates accounted for 13.6 ± 5.0% of gallbladder BAs after OCA treatment, resulting in a higher hydrophobicity index (OCA, 0.43 ± 0.09; placebo, 0.34 ± 0.07, p <0.05). Gallbladder FGF19 levels were 3-fold higher in OCA patients than in controls (OCA, 40.3 ± 16.5 ng/L; placebo, 13.5 ± 13.1 ng/ml; p <0.005). Gene expression analysis indicated that FGF19 mainly originated from the gallbladder epithelium.
CONCLUSIONS
Our results show for the first time an enrichment of FGF19 in human bile after OCA treatment. In accordance with its murine homolog FGF15, FGF19 might trigger relaxation and filling of the gallbladder which, in combination with increased cholesterol saturation and BA hydrophobicity, would enhance the risk of gallstone development.
LAY SUMMARY
Obeticholic acid increased human gallbladder cholesterol saturation and bile acid hydrophobicity, both decreasing cholesterol solubility in bile. Together with increased hepatobiliary levels of fibroblast growth factor 19, our findings suggest that pharmacological activation of the farnesoid X receptor increases the risk of gallstone formation. Clinical trial number: NCT01625026.",2019,"Gallbladder FGF19 was three-fold higher in OCA patients than in controls (OCA, 40.3±16.5 ng/L; placebo, 13.5±13.1 ng/mL;","['susceptible patients', 'Twenty patients awaiting laparoscopic cholecystectomy']","['hydrophobic OCA', 'placebo', 'Obeticholic acid', 'OCA', 'nuclear farnesoid X receptor (FXR) agonist obeticholic acid (OCA']","['serum, OCA increased FGF19', 'Serum bile acids (BAs), the BA synthesis marker C4 (7α-hydroxy-cholest-4-ene-3-one), and fibroblast growth factor 19 (FGF19', 'cholesterol solubility', 'Gallbladder FGF19', 'endogenous BAs', 'risk of gallstone formation', 'cholesterol saturation index', 'BAs in gallbladder bile']","[{'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C4707406', 'cui_str': 'Product containing farnesoid X receptor agonist'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0037628', 'cui_str': 'Solubility'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0947622', 'cui_str': 'Cholecystolithiasis'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005388', 'cui_str': 'Bile'}]",,0.181498,"Gallbladder FGF19 was three-fold higher in OCA patients than in controls (OCA, 40.3±16.5 ng/L; placebo, 13.5±13.1 ng/mL;","[{'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Al-Dury', 'Affiliation': 'Department of Molecular and Clinical Medicine/Wallenberg Laboratory, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Wahlström', 'Affiliation': 'Department of Molecular and Clinical Medicine/Wallenberg Laboratory, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Panzitt', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, Austria.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Thorell', 'Affiliation': 'Karolinska Institutet, Department of Clinical Science, Danderyd Hospital and Department of Surgery, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ståhlman', 'Affiliation': 'Department of Molecular and Clinical Medicine/Wallenberg Laboratory, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fickert', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, Austria.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Bäckhed', 'Affiliation': 'Department of Molecular and Clinical Medicine/Wallenberg Laboratory, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Fändriks', 'Affiliation': 'Department of Gastrosurgical Research and Education, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, Austria.'}, {'ForeName': 'Hanns-Ulrich', 'Initials': 'HU', 'LastName': 'Marschall', 'Affiliation': 'Department of Molecular and Clinical Medicine/Wallenberg Laboratory, Sahlgrenska Academy, University of Gothenburg, Sweden. Electronic address: hanns-ulrich.marschall@gu.se.'}]",Journal of hepatology,['10.1016/j.jhep.2019.06.011']
1082,31206787,Home vs hospital narrowband UVB treatment by a hand-held unit for new-onset vitiligo: A pilot randomized controlled study.,"PURPOSE
To compare the efficacy and safety of narrowband ultraviolet B (NB-UVB) phototherapy in home vs in hospital for the management of limited new-onset vitiligo.
METHODS
Patients with new-onset vitiligo (<3 months) with <5% body surface area involvement were recruited and randomly assigned to either a home-based or a hospital-based treatment group. Both groups were administered NB-UVB phototherapy thrice a week. The body surface area (BSA) involved with vitiligo, Vitiligo Area Scoring Index (VASI), the effectiveness of repigmentation, Vitiligo Quality of Life index (VitiQoL), and the cost of treatment were examined.
RESULTS
A total of 100 patients completed the study. Patients in both groups exhibited improvements demonstrated by BSA and VSAI decrease. No significant differences were found between the two groups in terms of skin repigmentation (P > 0.05). Improvements in the VitiQoL scores were reduced to the greatest degree at week 8 for all patients in both groups. Adverse events, such as painful erythema, burning, blistering, and excessive hyperpigmentation, were more frequently observed in the home-based treatment group than in the hospital-based treatment group. The cost of phototherapy in hospital exceeded the cost of home phototherapy after 7 weeks of treatment.
CONCLUSIONS
Home NB-UVB phototherapy treatment was as effective as treatment in hospital, but exhibited cost-effective and a better compliance. However, the education of the patients should be strengthened to avoid excessive UVB exposure and related adverse events.",2020,No significant differences were found between the two groups in terms of skin repigmentation (P > 0.05).,"['100 patients completed the study', 'Patients with new-onset vitiligo (<3\xa0months) with <5% body surface area involvement']","['Home vs hospital narrowband UVB treatment by a hand-held unit', 'NB-UVB phototherapy', 'narrowband ultraviolet B (NB-UVB) phototherapy', 'home-based or a hospital-based treatment group']","['BSA and VSAI decrease', 'Adverse events, such as painful erythema, burning, blistering, and excessive hyperpigmentation', 'skin repigmentation', 'body surface area (BSA) involved with vitiligo, Vitiligo Area Scoring Index (VASI), the effectiveness of repigmentation, Vitiligo Quality of Life index (VitiQoL), and the cost of treatment', 'efficacy and safety', 'VitiQoL scores']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy (procedure)'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1319688', 'cui_str': 'Blister - unit of product usage'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0162834', 'cui_str': 'Hypermelanosis'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.0273046,No significant differences were found between the two groups in terms of skin repigmentation (P > 0.05).,"[{'ForeName': 'Baoyi', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Dermatology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Zhouwei', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12495']
1083,31801155,"Meningitis, urinary tract, and bloodstream infections in very low birth weight infants enrolled in a heart rate characteristics monitoring trial.","BACKGROUND
Displaying heart rate characteristic (HRC) scores was associated with lower sepsis-associated mortality in very low birth weight (VLBW) infants in a multicenter randomized controlled trial (HeRO trial). The aim of this study was to test whether HRC indices rise before diagnosis of urinary tract infection (UTI) or meningitis, with and without concomitant BSI.
METHODS
Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants. The HRC index was analyzed 12 h prior to positive cultures compared to 36 h prior, using paired signed-rank tests.
RESULTS
UTI, meningitis, and BSI were diagnosed in 10%, 2%, and 24% of infants, respectively. The mean hourly HRC index was significantly higher 12 h prior to diagnosis of UTI and BSI compared to 36 h prior (UTI 2.07 versus 1.81; BSI 2.62 versus 2.25, both p < 0.0001). The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
CONCLUSIONS
In a large cohort of VLBW infants enrolled in the HeRO trial, the HRC index increased in the 24-h period prior to diagnosis of UTI and BSI but not meningitis.",2020,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
","['Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants', 'very low birth weight infants enrolled in a heart rate characteristic monitoring trial']",[],"['HRC index', 'baseline HRC index', 'Meningitis, urinary tract, and bloodstream infections', 'mean hourly HRC index', 'UTI, meningitis, and BSI']","[{'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0430403', 'cui_str': 'Cerebrospinal fluid culture (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0042027'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",,0.151055,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
","[{'ForeName': 'Joern-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA. hendrik.weitkamp@vumc.org.'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Aschner', 'Affiliation': 'Pediatrics, Hackensack Meridian Health School of Medicine, Nutley, NJ, USA.'}, {'ForeName': 'Wallly A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bancalari', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Perez', 'Affiliation': 'Pediatrix Medical Group, Orlando, FL, USA.'}, {'ForeName': 'Cristina T', 'Initials': 'CT', 'LastName': 'Navarrete', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Whit Walker', 'Affiliation': 'USC School of Medicine, Greenville Memorial Hospital, Greenville, SC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Porcelli', 'Affiliation': 'Pediatrics, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Palmer', 'Affiliation': 'Pediatrics, Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Grossarth', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Lake', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Fairchild', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}]",Pediatric research,['10.1038/s41390-019-0701-4']
1084,31227307,"Surgical Safety of Cytoreductive Nephrectomy Following Sunitinib: Results from the Multicentre, Randomised Controlled Trial of Immediate Versus Deferred Nephrectomy (SURTIME).","The European Organisation for Research and Treatment of Cancer SURTIME trial explored timing of sunitinib, a tyrosine kinase inhibitor (TKI), and cytoreductive nephrectomy (CN) in patients with metastatic renal cell carcinoma. Previous retrospective studies suggest increased surgery-related adverse events (AEs) after presurgical TKI. We report surgical safety from a randomised comparison of CN before or after sunitinib. In-hospital mortality, 30-d readmission rate, and intraoperative and 30-d postoperative AEs according to Common Terminology Criteria for Adverse Events version 4 and Clavien-Dindo (CD) were analysed. Patients were randomised 1:1 to immediate CN followed by sunitinib versus sunitinib followed by deferred CN 24h after the last dose of sunitinib. None of the tumours in the deferred arm became unresectable, and only two patients had a sunitinib-related delay of CN of >2wk. AEs related to surgery (all grades) in the immediate and deferred arms occurred in 52% and 53% after CN, respectively, although the number of intraoperative surgery-related AEs was higher in the immediate arm. Postoperative AEs (CD ≥3), 30-d readmission, and in-hospital mortality rates were 6.5%, 13%, and 4.3% in the immediate arm and 2.5%, 7.5%, and 2.5% in the deferred arm, respectively. There were no differences in surgery time, blood loss, and hospital stay. PATIENT SUMMARY: Patients with metastatic kidney cancer do not have more surgical complications irrespective of whether they are treated with systemic therapy before or after surgery.",2019,"AEs related to surgery (all grades) in the immediate and deferred arms occurred in 52% and 53% after CN, respectively, although the number of intraoperative surgery-related AEs was higher in the immediate arm.","['Patients with metastatic kidney cancer', 'patients with metastatic renal cell carcinoma']","['immediate CN followed by sunitinib versus sunitinib', 'cytoreductive nephrectomy (CN', 'Immediate Versus Deferred Nephrectomy', 'CN', 'Cytoreductive Nephrectomy Following Sunitinib']","['surgery time, blood loss, and hospital stay', 'Postoperative AEs (CD ≥3), 30-d readmission, and in-hospital mortality rates', 'hospital mortality, 30-d readmission rate, and intraoperative and 30-d postoperative AEs according to Common Terminology Criteria for Adverse Events version 4 and Clavien-Dindo (CD', 'number of intraoperative surgery-related AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0740457', 'cui_str': 'Cancer of Kidney'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1516728', 'cui_str': 'CTCAE (Common Terminology Criteria for Adverse Events)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.234586,"AEs related to surgery (all grades) in the immediate and deferred arms occurred in 52% and 53% after CN, respectively, although the number of intraoperative surgery-related AEs was higher in the immediate arm.","[{'ForeName': 'Roderick Emile', 'Initials': 'RE', 'LastName': 'De Bruijn', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mulders', 'Affiliation': 'Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Jewett', 'Affiliation': 'Department of Urology, Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'Department of Oncology, Cardiff Hospital, Wales, UK.'}, {'ForeName': 'Johan V', 'Initials': 'JV', 'LastName': 'Van Thienen', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Van Velthoven', 'Affiliation': 'Department of Urology, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Division of Medical Oncology, QEII Health Sciences Center, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Harm E', 'Initials': 'HE', 'LastName': 'van Melick', 'Affiliation': 'Department of Urology, Saint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Maureen J', 'Initials': 'MJ', 'LastName': 'Aarts', 'Affiliation': 'Department of Oncology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Jean B', 'Initials': 'JB', 'LastName': 'Lattouf', 'Affiliation': 'Department of Surgery Urology, University of Montreal Hospital Center, Quebec, Ontario, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Oncology, The Royal Free Hospital and Queen Mary University, London, UK.'}, {'ForeName': 'Igle J', 'Initials': 'IJ', 'LastName': 'De Jong', 'Affiliation': 'Department of Urology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Betrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Department of Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'Department of Statistics, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Collette', 'Affiliation': 'Department of Statistics, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Collette', 'Affiliation': 'Department of Statistics, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Haanen', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bex', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, The Netherlands; Department of Urology, The Royal Free Hospital and University College London, London, UK. Electronic address: a.bex@ucl.ac.uk.'}]",European urology,['10.1016/j.eururo.2019.06.006']
1085,31794625,Effect of Single-Fraction vs Multifraction Radiotherapy on Ambulatory Status Among Patients With Spinal Canal Compression From Metastatic Cancer: The SCORAD Randomized Clinical Trial.,"Importance
Malignant spinal canal compression, a major complication of metastatic cancer, is managed with radiotherapy to maintain mobility and relieve pain, although there is no standard radiotherapy regimen.
Objective
To evaluate whether single-fraction radiotherapy is noninferior to 5 fractions of radiotherapy.
Design, Setting, and Participants
Multicenter noninferiority randomized clinical trial conducted in 42 UK and 5 Australian radiotherapy centers. Eligible patients (n = 686) had metastatic cancer with spinal cord or cauda equina compression, life expectancy greater than 8 weeks, and no previous radiotherapy to the same area. Patients were recruited between February 2008 and April 2016, with final follow-up in September 2017.
Interventions
Patients were randomized to receive external beam single-fraction 8-Gy radiotherapy (n = 345) or 20 Gy of radiotherapy in 5 fractions over 5 consecutive days (n = 341).
Main Outcomes and Measures
The primary end point was ambulatory status at week 8, based on a 4-point scale and classified as grade 1 (ambulatory without the use of aids and grade 5 of 5 muscle power) or grade 2 (ambulatory using aids or grade 4 of 5 muscle power). The noninferiority margin for the difference in ambulatory status was -11%. Secondary end points included ambulatory status at weeks 1, 4, and 12 and overall survival.
Results
Among 686 randomized patients (median [interquartile range] age, 70 [64-77] years; 503 (73%) men; 44% had prostate cancer, 19% had lung cancer, and 12% had breast cancer), 342 (49.8%) were analyzed for the primary end point (255 patients died before the 8-week assessment). Ambulatory status grade 1 or 2 at week 8 was achieved by 115 of 166 (69.3%) patients in the single-fraction group vs 128 of 176 (72.7%) in the multifraction group (difference, -3.5% [1-sided 95% CI, -11.5% to ∞]; P value for noninferiority = .06). The difference in ambulatory status grade 1 or 2 in the single-fraction vs multifraction group was -0.4% (63.9% vs 64.3%; [1-sided 95% CI, -6.9 to ∞]; P value for noninferiority = .004) at week 1, -0.7% (66.8% vs 67.6%; [1-sided 95% CI, -8.1 to ∞]; P value for noninferiority = .01) at week 4, and 4.1% (71.8% vs 67.7%; [1-sided 95% CI, -4.6 to ∞]; P value for noninferiority = .002) at week 12. Overall survival rates at 12 weeks were 50% in the single-fraction group vs 55% in the multifraction group (stratified hazard ratio, 1.02 [95% CI, 0.74-1.41]). Of the 11 other secondary end points that were analyzed, the between-group differences were not statistically significant or did not meet noninferiority criterion.
Conclusions and Relevance
Among patients with malignant metastatic solid tumors and spinal canal compression, a single radiotherapy dose, compared with a multifraction dose delivered over 5 days, did not meet the criterion for noninferiority for the primary outcome (ambulatory at 8 weeks). However, the extent to which the lower bound of the CI overlapped with the noninferiority margin should be considered when interpreting the clinical importance of this finding.
Trial Registration
ISRCTN Identifiers: ISRCTN97555949 and ISRCTN97108008.",2019,"Overall survival rates at 12 weeks were 50% in the single-fraction group vs 55% in the multifraction group (stratified hazard ratio, 1.02","['Patients With Spinal Canal Compression From Metastatic Cancer', '70 [64-77] years; 503 (73%) men; 44% had prostate cancer, 19% had lung cancer, and 12% had breast cancer), 342 (49.8%) were analyzed for the primary end point', '42 UK and 5 Australian radiotherapy centers', 'patients with malignant metastatic solid tumors and spinal canal compression', 'Patients were recruited between February 2008 and April 2016, with final follow-up in September 2017', '686 randomized patients (median [interquartile range] age', 'Eligible patients (n\u2009=\u2009686) had metastatic cancer with spinal cord or cauda equina compression, life expectancy greater than 8 weeks, and no previous radiotherapy to the same area']","['single-fraction radiotherapy', 'external beam single-fraction 8-Gy radiotherapy (n\u2009=\u2009345) or 20 Gy of radiotherapy', 'radiotherapy', 'Single-Fraction vs Multifraction Radiotherapy']","['ambulatory status', 'ambulatory status grade', 'ambulatory status at weeks 1, 4, and 12 and overall survival', 'Ambulatory Status', 'ambulatory status at week 8, based on a 4-point scale and classified as grade 1 (ambulatory without the use of aids and grade 5 of 5 muscle power) or grade 2 (ambulatory using aids or grade 4 of 5 muscle power', 'Overall survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037922', 'cui_str': 'Spinal Canal'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037925', 'cui_str': 'Myelon'}, {'cui': 'C0007458', 'cui_str': 'Cauda Equina'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0222045'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",686.0,0.209207,"Overall survival rates at 12 weeks were 50% in the single-fraction group vs 55% in the multifraction group (stratified hazard ratio, 1.02","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hoskin', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, United Kingdom.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Hopkins', 'Affiliation': 'Bristol Centre for Haematology and Oncology Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Misra', 'Affiliation': 'The Christie Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Holt', 'Affiliation': 'Princess Alexandra Hospital, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Rhona', 'Initials': 'R', 'LastName': 'McMenemin', 'Affiliation': 'The Freeman Hospital, Newcastle, United Kingdom.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Dubois', 'Affiliation': 'Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McKinna', 'Affiliation': 'Royal Sussex County Hospital, Brighton, United Kingdom.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Foran', 'Affiliation': 'Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Krishnaswamy', 'Initials': 'K', 'LastName': 'Madhavan', 'Affiliation': 'Southend University Hospital, United Kingdom.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'MacGregor', 'Affiliation': 'Raigmore Hospital, Inverness, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Southampton General Hospital, Southampton, United Kingdom.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': ""O'Rourke"", 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Lester', 'Affiliation': 'Velindre Cancer Centre, Cardiff, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Sevitt', 'Affiliation': 'Kent Oncology Centre, Maidstone, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Roos', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Castle Hill Hospital, Hull, United Kingdom.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': 'Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Seonaid', 'Initials': 'S', 'LastName': 'Arnott', 'Affiliation': 'Raigmore Hospital, Inverness, United Kingdom.'}, {'ForeName': 'Sharon Shibu', 'Initials': 'SS', 'LastName': 'Thomas', 'Affiliation': 'Southend University Hospital, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Forsyth', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Beare', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Reczko', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}]",JAMA,['10.1001/jama.2019.17913']
1086,31232684,Nocturnal temperature-controlled laminar airflow device for adults with severe allergic asthma: the LASER RCT.,"BACKGROUND
Severe asthma exacerbations are costly to patients and the NHS, and occur frequently in severely allergic patients.
OBJECTIVE
To ascertain whether or not nocturnal temperature-controlled laminar airflow (TLA) device usage over 12 months can reduce severe exacerbations and improve asthma control and quality of life compared with a placebo device, while being cost-effective and acceptable to adults with severe allergic asthma.
DESIGN
A pragmatic, multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial with qualitative interviews. The trial included an internal pilot with qualitative focus groups.
SETTING
Fourteen hospitals in the UK that manage patients with severe asthma.
PARTICIPANTS
Adults (16-75 years) with severe, poorly controlled, exacerbation-prone asthma despite high-intensity treatment, and who are sensitised to a perennial indoor aeroallergen.
INTERVENTION
Nocturnal, home-based TLA treatment using an Airsonett ® (Airsonett AB, Ängelholm, Sweden) device. The comparator was a placebo device that was identical to the active device except that it did not deliver the laminar airflow. Participants were allocated 1 : 1 to TLA therapy or placebo, minimised by site, origin of case, baseline severe exacerbation frequency, maintenance oral corticosteroid use and pre-bronchodilator forced expiratory volume in 1 second.
MAIN OUTCOME MEASURES
Primary outcome - frequency of severe asthma exacerbations occurring within the 12-month follow-up period, defined as worsening of asthma requiring systemic corticosteroids [≥ 30 mg of prednisolone or equivalent daily (or ≥ 50% increase in dose if on maintenance dose of ≥ 30 mg of prednisolone)] for ≥ 3 days. Secondary outcomes - changes in asthma control, lung function, asthma-specific and global quality of life for participants, adherence to the intervention, device acceptability, health-care resource use and cost-effectiveness.
RESULTS
Between May 2014 and January 2016, 489 patients consented to participate in the trial, of whom 249 failed screening and 240 were randomised ( n = 119 in the treatment group and n = 121 in the placebo group); all were analysed. In total, 202 participants (84%) reported use of the device for 9-12 months. Qualitative analyses showed high levels of acceptability. The mean [standard deviation (SD)] rate of severe exacerbations did not differ between groups [active 1.39 (1.57), placebo 1.48 (2.03); risk ratio 0.92, 95% CI 0.66 to 1.27; p = 0.616]. There were no significant differences in secondary outcomes for lung function, except for a reduction in mean daily peak expiratory flow [mean (SD) difference 14.7 l/minute (7.35 l/minute), 95% CI 0.32 to 29.1 l/minute; p = 0.045) for those in the active device group. There were no differences in asthma control or airway inflammation and no serious harms related to the device. No significant difference between the groups in quality-adjusted life-years gained over 1 year was observed. In addition, there was no difference in generic or disease-specific health-related quality of life overall, although statistically significant higher quality of life at month 6 was observed. Increases in quality of life were not sufficient to offset the annual costs associated with use of the TLA device.
LIMITATIONS
Missing outcome data could have resulted in an underestimation of exacerbations and rendered the study inconclusive.
CONCLUSIONS
Within the limits of the data, no consistent benefits of the active device were demonstrated, and the differences observed were not sufficient to make the device cost-effective. The types of patients who may benefit from the TLA device, and the reasons for large reductions in exacerbation frequency in severe asthma trials, which also incorporate other methods of recording exacerbations, need to be explored.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN46346208.
FUNDING
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 29. See the NIHR Journals Library website for further project information.",2019,"The mean [standard deviation (SD)] rate of severe exacerbations did not differ between groups [active 1.39 (1.57), placebo 1.48 (2.03); risk ratio 0.92, 95% CI 0.66 to 1.27; p = 0.616].","['Fourteen hospitals in the UK that manage patients with severe asthma', 'Between May 2014 and January 2016, 489 patients consented to participate in the trial, of whom 249 failed screening and 240 were randomised ( n \u2009=\u2009119 in the treatment group and n', 'Adults (16-75 years) with severe, poorly controlled, exacerbation-prone asthma despite high-intensity treatment, and who are sensitised to a perennial indoor aeroallergen', 'adults with severe allergic asthma']","['Nocturnal, home-based TLA treatment using an Airsonett ® (Airsonett AB, Ängelholm, Sweden) device', 'TLA therapy or placebo, minimised by site, origin of case, baseline severe exacerbation frequency, maintenance oral corticosteroid use and pre-bronchodilator forced expiratory volume in 1 second', 'LASER RCT', 'placebo', 'Nocturnal temperature-controlled laminar airflow device', 'prednisolone']","['lung function', 'generic or disease-specific health-related quality of life overall', 'worsening of asthma requiring systemic corticosteroids [≥', 'quality-adjusted life-years gained over 1 year', 'frequency of severe asthma exacerbations', 'asthma control and quality of life', 'asthma control, lung function, asthma-specific and global quality of life for participants, adherence to the intervention, device acceptability, health-care resource use and cost-effectiveness', 'asthma control or airway inflammation', 'quality of life', 'mean [standard deviation (SD)] rate of severe exacerbations', 'mean daily peak expiratory flow']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0303721', 'cui_str': 'Americium-240 (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen (attribute)'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0232001', 'cui_str': 'Laminar airflow, function (observable entity)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}]",202.0,0.606909,"The mean [standard deviation (SD)] rate of severe exacerbations did not differ between groups [active 1.39 (1.57), placebo 1.48 (2.03); risk ratio 0.92, 95% CI 0.66 to 1.27; p = 0.616].","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Kapoor', 'Affiliation': 'South East Health Technologies Alliance, Henfield, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Storrar', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Respiratory Department, Portsmouth, UK.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Balls', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Respiratory Department, Portsmouth, UK.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Brown', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Respiratory Department, Portsmouth, UK.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Mansur', 'Affiliation': 'Heartlands Hospital, Respiratory Department, Birmingham, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hedley', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Respiratory Department, Portsmouth, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Respiratory Department, Portsmouth, UK.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Shirkey', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Luengo-Fernandez', 'Affiliation': 'Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Dewey', 'Affiliation': 'School of Health Sciences and Social Work, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Marshall', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Respiratory Department, Portsmouth, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Fogg', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Respiratory Department, Portsmouth, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Boughton', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Respiratory Department, Portsmouth, UK.'}, {'ForeName': 'Najib', 'Initials': 'N', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Primary Care Trials Unit, Nuffield Department of Primary Care Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bradding', 'Affiliation': 'Leicester Respiratory Biomedical Research Unit, Leicester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Howarth', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Respiratory Department, Southampton, UK.'}, {'ForeName': 'Anoop J', 'Initials': 'AJ', 'LastName': 'Chauhan', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Respiratory Department, Portsmouth, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23290']
1087,31743998,Effects of a Modified Tai Chi Program on Older People with Mild Dementia: A Randomized Controlled Trial.,"BACKGROUND
Tai Chi exercise is a non-pharmacological therapy that has received increased attention in recent years. A Tai Chi program has been specifically modified for older people with cognitive impairments by the research team.
OBJECTIVE
We aim to assess the effects of this Tai Chi program on mild dementia.
METHODS
Eighty older people with mild dementia were recruited and randomly assigned to a Tai Chi group or a control group. The Tai Chi group practiced the Tai Chi program three times a week for 10 months, while the control group continued receiving routine treatments. All participants were assessed for cognitive function, behavior/mood, and activities of daily living at baseline, 5 months, and 10 months.
RESULTS
The Tai Chi group performed better than the control group. Repeated measures ANOVA revealed a significant group×time interaction in the Montreal Cognitive Assessment (MoCA). Further analysis of sub-items of the MoCA showed a significant time effect in naming and abstraction. It was statistically significant in both main effect of time and group×time interaction in the Neuropsychiatric Inventory (NPI) and Geriatric Depression Scale (GDS). Paired sample t test showed the Tai Chi group scored lower at 5 and 10 months in the NPI and at 10 months in the GDS compared with baseline. The Tai Chi group scored lower than the control group at 10 months in the NPI and GDS.
CONCLUSION
The results suggest this Tai Chi program may help improve cognitive function and mental well-being for older adults with mild dementia.",2019,Paired sample t test showed the Tai Chi group scored lower at 5 and 10 months in the NPI and at 10 months in the GDS compared with baseline.,"['Eighty older people with mild dementia', 'Older People with Mild Dementia', 'older adults with mild dementia', 'mild dementia', 'older people with cognitive impairments']","['control group continued receiving routine treatments', 'Tai Chi exercise', 'Tai Chi program', 'Tai Chi group or a control group', 'Modified Tai Chi Program']","['Neuropsychiatric Inventory (NPI) and Geriatric Depression Scale (GDS', 'cognitive function', 'cognitive function, behavior/mood, and activities of daily living', 'Montreal Cognitive Assessment (MoCA']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C3496286'}]",80.0,0.0516447,Paired sample t test showed the Tai Chi group scored lower at 5 and 10 months in the NPI and at 10 months in the GDS compared with baseline.,"[{'ForeName': 'Nayan', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Xiangjiang', 'Initials': 'X', 'LastName': 'Rong', 'Affiliation': 'School of Kinesiology and Health, Capital University of Physical Education and Sport, Beijing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Champ', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England, Bristol, UK.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Graduate School, Capital University of Physical Education and Sport, Beijing, China.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Mu', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Yueqing', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Zongjuan', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190487']
1088,31230925,Short versus long axis ultrasound guided approach for internal jugular vein cannulations: A prospective randomized controlled trial.,"OBJECTIVES
Ultrasound-guided internal jugular vein cannulation is a standard procedure performed in ICUs worldwide. According to the guidelines, the short-axis approach is recommended over the long-axis approach for IJV cannulation. Double-operator cannulation is more convenient for the said procedure. However, the guidelines favor single-operator cannulation due to limited trials. We hypothesized that double-operator long-axis cannulation will be faster and have fewer complications than double-operator short-axis cannulation.
METHODS
This was a prospective, randomized trial of patients who needed central venous catheterization in the intensive care unit. The eligible patients were randomized into two groups. In one group, the short-axis view by two operators was used for cannulation, and the long-axis view by 2 operators was used in the other group. The time elapsed from skin puncture to guide-wire insertion.
RESULTS
The central venous catheter was placed by ultrasound guidance in all 100 patients. No significant differences were observed in the patient characteristics between the two groups. The mean time of insertion was 74.2 ± 110.1 s with the short-axis approach compared with 70.3 ± 97.3 s with the long-axis approach. The frequency of complications was also significantly lower with the long-axis approach.
DISCUSSION
The long-axis view for IJV cannulation has similar insertion and procedure timings to the short-axis view. However, the complication rate and number of needle punctures required were less with the long-axis view than with those with the short-axis view.",2020,"However, the complication rate and number of needle punctures required were less with the long-axis view than with those with the short-axis view.",['patients who needed central venous catheterization in the intensive care unit'],"['Ultrasound-guided internal jugular vein cannulation', 'Short versus long axis ultrasound guided approach for internal jugular vein cannulations', 'double-operator long-axis cannulation', 'Double-operator cannulation']","['frequency of complications', 'mean time of insertion', 'complication rate and number of needle punctures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0007435', 'cui_str': 'Central Catheterization'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0522487', 'cui_str': 'Long axis (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}]",100.0,0.0343039,"However, the complication rate and number of needle punctures required were less with the long-axis view than with those with the short-axis view.","[{'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Rath', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Shakti Bedanta', 'Initials': 'SB', 'LastName': 'Mishra', 'Affiliation': 'Department of Anaesthesiology, IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India. Electronic address: shaktibedantamishra@soauniversity.ac.in.'}, {'ForeName': 'Bhabani', 'Initials': 'B', 'LastName': 'Pati', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Sanjib Kumar', 'Initials': 'SK', 'LastName': 'Dhar', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Snigdha', 'Initials': 'S', 'LastName': 'Ipsita', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Samal', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Afzal', 'Initials': 'A', 'LastName': 'Azim', 'Affiliation': 'SGPGI, Lucknow 226014, India.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.06.010']
1089,31839368,"Bupivacaine Extended-Release Liposomal Injection Versus Bupivacaine HCl for Early Postoperative Pain Control Following Wrist Operations: A Prospective, Randomized Control Trial.","PURPOSE
This study evaluated pain control after wrist operations using a long-acting local anesthetic, liposomal bupivacaine, compared with the standard local anesthetic, bupivacaine HCl.
METHODS
Patients undergoing elective carpometacarpal joint arthroplasty and proximal row carpectomy were eligible. Those meeting inclusion criteria were enrolled before surgery and were randomized to receive an intraoperative injection of liposomal bupivacaine or bupivacaine HCl. Primary outcomes included intraoperative and postoperative opioid requirements and pain levels. On the first 4 postoperative days, phone contact assessed pain level by numeric rating scale, number of opioids taken in each 24-hour period, and efficacy of anesthesia and opioid side effects with overall benefit of analgesia score.
RESULTS
Postoperative pain scores for 52 patients measured by numeric rating scale demonstrated that liposomal bupivacaine and bupivacaine HCl were similar for pain control. Pain scores and opioid use were similar during the first 4 postoperative days. Opioid use on day 1 was slightly lower with liposomal bupivacaine. There were no statistically significant differences in any postoperative outcome between groups.
CONCLUSIONS
Liposomal bupivacaine and bupivacaine HCl have similar effects in the treatment of early postoperative pain after trapeziometacarpal suspension arthroplasty and proximal row carpectomy. Neither drug demonstrated a clear advantage in this study.
TYPE OF STUDY/LEVEL OF EVIDENCE
Therapeutic II.",2020,"CONCLUSIONS
Liposomal bupivacaine and bupivacaine HCl have similar effects in the treatment of early postoperative pain after trapeziometacarpal suspension arthroplasty and proximal row carpectomy.","['Patients undergoing elective carpometacarpal joint arthroplasty and proximal row carpectomy were eligible', 'early postoperative pain after trapeziometacarpal suspension arthroplasty and proximal row carpectomy', 'Following Wrist Operations']","['intraoperative injection of liposomal bupivacaine or bupivacaine HCl', 'liposomal bupivacaine', 'bupivacaine HCl', 'Bupivacaine', 'Bupivacaine HCl', 'Liposomal bupivacaine']","['pain control', 'pain level by numeric rating scale, number of opioids taken in each 24-hour period, and efficacy of anesthesia and opioid side effects with overall benefit of analgesia score', 'intraoperative and postoperative opioid requirements and pain levels', 'Postoperative pain scores', 'Early Postoperative Pain Control', 'Pain\xa0scores and opioid use', 'postoperative outcome', 'numeric rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0224620', 'cui_str': 'Carpometacarpal Joints'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0408909', 'cui_str': 'Proximal row carpectomy (procedure)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0187064', 'cui_str': 'Operative procedure on wrist'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}]","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0222045'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.296748,"CONCLUSIONS
Liposomal bupivacaine and bupivacaine HCl have similar effects in the treatment of early postoperative pain after trapeziometacarpal suspension arthroplasty and proximal row carpectomy.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Dale', 'Affiliation': 'Department of Plastic Surgery, University of Tennessee College of Medicine, Chattanooga, TN.'}, {'ForeName': 'Chase T', 'Initials': 'CT', 'LastName': 'Kluemper', 'Affiliation': 'Department of Orthopedic Surgery, University of Tennessee College of Medicine, Chattanooga, TN. Electronic address: chasekluemper@gmail.com.'}, {'ForeName': 'S Justin', 'Initials': 'SJ', 'LastName': 'Cowart', 'Affiliation': 'Department of Orthopedic Surgery, University of Tennessee College of Medicine, Chattanooga, TN.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Jemison', 'Affiliation': 'Department of Orthopedic Surgery, University of Tennessee College of Medicine, Chattanooga, TN.'}, {'ForeName': 'J Woody', 'Initials': 'JW', 'LastName': 'Kennedy', 'Affiliation': 'Department of Plastic Surgery, University of Tennessee College of Medicine, Chattanooga, TN.'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Mathematics, University of Tennessee at Chattanooga, Chattanooga, TN.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Brzezienski', 'Affiliation': 'Department of Plastic Surgery, University of Tennessee College of Medicine, Chattanooga, TN.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Department of Plastic Surgery, University of Tennessee College of Medicine, Chattanooga, TN.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2019.10.009']
1090,31160251,"Identification of the optimal combination dosing schedule of neoadjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma (OpACIN-neo): a multicentre, phase 2, randomised, controlled trial.","BACKGROUND
The outcome of patients with macroscopic stage III melanoma is poor. Neoadjuvant treatment with ipilimumab plus nivolumab at the standard dosing schedule induced pathological responses in a high proportion of patients in two small independent early-phase trials, and no patients with a pathological response have relapsed after a median follow up of 32 months. However, toxicity of the standard ipilimumab plus nivolumab dosing schedule was high, preventing its broader clinical use. The aim of the OpACIN-neo trial was to identify a dosing schedule of ipilimumab plus nivolumab that is less toxic but equally effective.
METHODS
OpACIN-neo is a multicentre, open-label, phase 2, randomised, controlled trial. Eligible patients were aged at least 18 years, had a WHO performance status of 0-1, had resectable stage III melanoma involving lymph nodes only, and measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1. Patients were enrolled from three medical centres in Australia, Sweden, and the Netherlands, and were randomly assigned (1:1:1), stratified by site, to one of three neoadjuvant dosing schedules: group A, two cycles of ipilimumab 3 mg/kg plus nivolumab 1 mg/kg once every 3 weeks intravenously; group B, two cycles of ipilimumab 1 mg/kg plus nivolumab 3 mg/kg once every 3 weeks intravenously; or group C, two cycles of ipilimumab 3 mg/kg once every 3 weeks directly followed by two cycles of nivolumab 3 mg/kg once every 2 weeks intravenously. The investigators, site staff, and patients were aware of the treatment assignment during the study participation. Pathologists were masked to treatment allocation and all other data. The primary endpoints were the proportion of patients with grade 3-4 immune-related toxicity within the first 12 weeks and the proportion of patients achieving a radiological objective response and pathological response at 6 weeks. Analyses were done in all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02977052, and is ongoing with an additional extension cohort and to complete survival analysis.
FINDINGS
Between Nov 24, 2016 and June 28, 2018, 105 patients were screened for eligibility, of whom 89 (85%) eligible patients were enrolled and randomly assigned to one of the three groups. Three patients were excluded after randomisation because they were found to be ineligible, and 86 received at least one dose of study drug; 30 patients in group A, 30 in group B, and 26 in group C (accrual to this group was closed early upon advice of the Data Safety Monitoring Board on June 4, 2018 because of severe adverse events). Within the first 12 weeks, grade 3-4 immune-related adverse events were observed in 12 (40%) of 30 patients in group A, six (20%) of 30 in group B, and 13 (50%) of 26 in group C. The difference in grade 3-4 toxicity between group B and A was -20% (95% CI -46 to 6; p=0·158) and between group C and group A was 10% (-20 to 40; p=0·591). The most common grade 3-4 adverse events were elevated liver enzymes in group A (six [20%)]) and colitis in group C (five [19%]); in group B, none of the grade 3-4 adverse events were seen in more than one patient. One patient (in group A) died 9·5 months after the start of treatment due to the consequences of late-onset immune-related encephalitis, which was possibly treatment-related. 19 (63% [95% CI 44-80]) of 30 patients in group A, 17 (57% [37-75]) of 30 in group B, and nine (35% [17-56]) of 26 in group C achieved a radiological objective response, while pathological responses occurred in 24 (80% [61-92]) patients in group A, 23 (77% [58-90]) in group B, and 17 (65% [44-83]) in group C.
INTERPRETATION
OpACIN-neo identified a tolerable neoadjuvant dosing schedule (group B: two cycles of ipilimumab 1 mg/kg plus nivolumab 3 mg/kg) that induces a pathological response in a high proportion of patients and might be suitable for broader clinical use. When more mature data confirm these early observations, this schedule should be tested in randomised phase 3 studies versus adjuvant therapies, which are the current standard-of-care systemic therapy for patients with stage III melanoma.
FUNDING
Bristol-Myers Squibb.",2019,"The most common grade 3-4 adverse events were elevated liver enzymes in group A (six [20%)]) and colitis in group C (five [19%]); in group B, none of the grade 3-4 adverse events were seen in more than one patient.","['macroscopic stage III melanoma (OpACIN-neo', 'Between Nov 24, 2016 and June 28, 2018, 105 patients were screened for eligibility, of whom 89 (85%) eligible patients', 'patients with stage III melanoma', 'Patients were enrolled from three medical centres in Australia, Sweden, and the Netherlands', 'patients with macroscopic stage III melanoma', 'Eligible patients were aged at least 18 years, had a WHO performance status of 0-1, had resectable stage III melanoma involving lymph nodes only, and measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1']","['ipilimumab plus nivolumab', 'ipilimumab 3 mg/kg plus nivolumab', 'neoadjuvant ipilimumab plus nivolumab', 'ipilimumab', 'ipilimumab 1 mg/kg plus nivolumab']","['pathological responses', 'grade 3-4 toxicity', 'radiological objective response, while pathological responses', 'proportion of patients with grade 3-4 immune-related toxicity', 'toxicity', 'grade 3-4 immune-related adverse events', 'radiological objective response and pathological response']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",105.0,0.32307,"The most common grade 3-4 adverse events were elevated liver enzymes in group A (six [20%)]) and colitis in group C (five [19%]); in group B, none of the grade 3-4 adverse events were seen in more than one patient.","[{'ForeName': 'Elisa A', 'Initials': 'EA', 'LastName': 'Rozeman', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Menzies', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Chandra', 'Initials': 'C', 'LastName': 'Adhikari', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Bierman', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Bart A', 'Initials': 'BA', 'LastName': 'van de Wiel', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Scolyer', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Krijgsman', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Eriksson', 'Affiliation': 'Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Annegien', 'Initials': 'A', 'LastName': 'Broeks', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Johannes V', 'Initials': 'JV', 'LastName': 'van Thienen', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Guminski', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Alex Torres', 'Initials': 'AT', 'LastName': 'Acosta', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Ter Meulen', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Anne Miek', 'Initials': 'AM', 'LastName': 'Koenen', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Linda J W', 'Initials': 'LJW', 'LastName': 'Bosch', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Kerwin', 'Initials': 'K', 'LastName': 'Shannon', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Loes M', 'Initials': 'LM', 'LastName': 'Pronk', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gonzalez', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': ""Ch'ng"", 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia; Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Lindsay G', 'Initials': 'LG', 'LastName': 'Grijpink-Ongering', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Stretch', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia; Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Heijmink', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'John B A G', 'Initials': 'JBAG', 'LastName': 'Haanen', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Omgo E', 'Initials': 'OE', 'LastName': 'Nieweg', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia; Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Willem M C', 'Initials': 'WMC', 'LastName': 'Klop', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Zuur', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Robyn P M', 'Initials': 'RPM', 'LastName': 'Saw', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia; Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Winan J', 'Initials': 'WJ', 'LastName': 'van Houdt', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Peeper', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Spillane', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Hansson', 'Affiliation': 'Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Ton N', 'Initials': 'TN', 'LastName': 'Schumacher', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute of Australia, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, Netherlands. Electronic address: c.blank@nki.nl.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30151-2']
1091,31262189,"Phytosterol enhances oral nifedipine treatment in pregnancy-induced preeclampsia: A placebo-controlled, double-blinded, randomized clinical trial.",,2019,,['pregnancy-induced preeclampsia'],"['placebo', 'Phytosterol enhances oral nifedipine']",[],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}]",[],,0.779672,,"[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics and Gynecology, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Huanrong', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': ""Department of Obstetrics and Gynecology, Liaocheng People's Hospital, Liaocheng 252000, China.""}]","Experimental biology and medicine (Maywood, N.J.)",['10.1177/1535370219861574']
1092,31264958,Selective laser trabeculoplasty versus drops for newly diagnosed ocular hypertension and glaucoma: the LiGHT RCT.,"BACKGROUND
Newly diagnosed open-angle glaucoma (OAG) and ocular hypertension (OHT) are habitually treated with intraocular pressure (IOP)-lowering eyedrops. Selective laser trabeculoplasty (SLT) is a safe alternative to drops and is rarely used as first-line treatment.
OBJECTIVES
To compare health-related quality of life (HRQoL) in newly diagnosed, treatment-naive patients with OAG or OHT, treated with two treatment pathways: topical IOP-lowering medication from the outset (Medicine-1st) or primary SLT followed by topical medications as required (Laser-1st). We also compared the clinical effectiveness and cost-effectiveness of the two pathways.
DESIGN
A 36-month pragmatic, unmasked, multicentre randomised controlled trial.
SETTINGS
Six collaborating specialist glaucoma clinics across the UK.
PARTICIPANTS
Newly diagnosed patients with OAG or OHT in one or both eyes who were aged ≥ 18 years and able to provide informed consent and read and understand English. Patients needed to qualify for treatment, be able to perform a reliable visual field (VF) test and have visual acuity of at least 6 out of 36 in the study eye. Patients with VF loss mean deviation worse than -12 dB in the better eye or -15 dB in the worse eye were excluded. Patients were also excluded if they had congenital, early childhood or secondary glaucoma or ocular comorbidities; if they had any previous ocular surgery except phacoemulsification, at least 1 year prior to recruitment or any active treatment for ophthalmic conditions; if they were pregnant; or if they were unable to use topical medical therapy or had contraindications to SLT.
INTERVENTIONS
SLT according to a predefined protocol compared with IOP-lowering eyedrops, as per national guidelines.
MAIN OUTCOME MEASURES
The primary outcome was HRQoL at 3 years [as measured using the EuroQol-5 Dimensions, five-level version (EQ-5D-5L) questionnaire]. Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness and safety.
RESULTS
Of the 718 patients enrolled, 356 were randomised to Laser-1st (initial SLT followed by routine medical treatment) and 362 to Medicine-1st (routine medical treatment only). A total of 652 (91%) patients returned the primary outcome questionnaire at 36 months. The EQ-5D-5L score was not significantly different between the two arms [adjusted mean difference (Laser-1st - Medicine-1st) 0.01, 95% confidence interval (CI) -0.01 to 0.03; p = 0.23] at 36 months. Over 36 months, the proportion of visits at which IOP was within the target range was higher in the Laser-1st arm (93.0%, 95% CI 91.9% to 94.0%) than in the Medicine-1st arm (91.3%, 95% CI 89.9% to 92.5%), with IOP-lowering glaucoma surgery required in 0 and 11 patients, respectively. There was a 97% probability of Laser-1st being more cost-effective than Medicine-1st for the NHS, at a willingness to pay for a quality-adjusted life-year of £20,000, with a reduction in ophthalmology costs of £458 per patient (95% of bootstrap iterations between -£585 and -£345).
LIMITATION
An unmasked design, although a limitation, was essential to capture any treatment effects on patients' perception. The EQ-5D-5L questionnaire is a generic tool used in multiple settings and may not have been the most sensitive tool to investigate HRQoL.
CONCLUSIONS
Compared with medication, SLT provided a stable, drop-free IOP control to 74.2% of patients for at least 3 years, with a reduced need for surgery, lower cost and comparable HRQoL. Based on the evidence, SLT seems to be the most cost-effective first-line treatment option for OAG and OHT, also providing better clinical outcomes.
FUTURE WORK
Longitudinal research into the clinical efficacy of SLT as a first-line treatment will specify the long-term differences of disease progression, treatment intensity and ocular surgery rates between the two pathways.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN32038223.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 31. See the NIHR Journals Library website for further project information.",2019,"There was a 97% probability of Laser-1st being more cost-effective than Medicine-1st for the NHS, at a willingness to pay for a quality-adjusted life-year of £20,000, with a reduction in ophthalmology costs of £458 per patient (95% of bootstrap iterations between -£585 and -£345).
","['Newly diagnosed patients with OAG or OHT in one or both eyes who were aged ≥\u200918 years and able to provide informed consent and read and understand English', 'Six collaborating specialist glaucoma clinics across the UK', '718 patients enrolled', 'newly diagnosed ocular hypertension and glaucoma', 'Patients were also excluded if they had congenital, early childhood or secondary glaucoma or ocular comorbidities; if they had any previous ocular surgery except phacoemulsification, at least 1 year prior to recruitment or any active treatment for ophthalmic conditions; if they were pregnant; or if they were unable to use topical medical therapy or had contraindications to SLT', 'newly diagnosed, treatment-naive patients with OAG or OHT, treated with two treatment pathways: topical IOP-lowering medication from the outset (Medicine-1st) or primary SLT followed by topical medications as required (Laser-1st']","['IOP-lowering eyedrops', 'intraocular pressure (IOP)-lowering eyedrops', 'Selective laser trabeculoplasty', 'Selective laser trabeculoplasty (SLT']","['IOP-lowering glaucoma surgery', 'health-related quality of life (HRQoL', 'EQ-5D-5L score', 'cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness and safety', 'ophthalmology costs', 'HRQoL at 3 years [as measured using the EuroQol-5 Dimensions, five-level version (EQ-5D-5L) questionnaire', 'clinical effectiveness and cost-effectiveness', 'proportion of visits at which IOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0149893', 'cui_str': 'Secondary glaucoma (disorder)'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0558288', 'cui_str': 'prn'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1706188', 'cui_str': 'Glaucoma surgery specialty'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",718.0,0.175425,"There was a 97% probability of Laser-1st being more cost-effective than Medicine-1st for the NHS, at a willingness to pay for a quality-adjusted life-year of £20,000, with a reduction in ophthalmology costs of £458 per patient (95% of bootstrap iterations between -£585 and -£345).
","[{'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Gazzard', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Konstantakopoulou', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garway-Heath', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Vickerstaff', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wormald', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Rubin', 'Affiliation': 'Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Health Research, Institute of Epidemiology and Health Care, University College London, London, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Buszewicz', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23310']
1093,31796472,"Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPG BFM ): protocol for a prospective, randomised, non-controlled, multicentre study.","INTRODUCTION
Portal hypertension (PH) is a severe disease with a poor outcome. Hepatic venous pressure gradient (HVPG), the current gold standard to detect PH, is available only in few hospitals due to its invasiveness and technical difficulty. This study aimed to establish and assess a novel model to calculate HVPG based on biofluid mechanics.
METHODS AND ANALYSIS
This is a prospective, randomised, non-controlled, multicentre trial. A total of 248 patients will be recruited in this study, and each patient will undergo CT, blood tests, Doppler ultrasound and HVPG measurement. The study consists of two independent and consecutive cohorts: original cohort (124 patients) and validation cohort (124 patients). The researchers will establish and improve the HVPG using biofluid mechanics (HVPG BFM )model in the original cohort and assess the model in the validation cohort.
ETHICS AND DISSEMINATION
The study was approved by the Scientific Research Projects Approval Determination of Independent Ethics Committee of Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (approval number 2017-430 T326). Study findings will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER
NCT03470389.",2019,The study consists of two independent and consecutive cohorts: original cohort (124 patients) and validation cohort (124 patients).,"['two independent and consecutive cohorts: original cohort (124 patients) and validation cohort (124 patients', ""Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (approval number 2017-430\u2009T326"", '248 patients']","['hepatic venous pressure gradient using biofluid mechanics (HVPG BFM ', 'Hepatic venous pressure gradient (HVPG']",[],"[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205443', 'cui_str': 'Ninth (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0183964', 'cui_str': 'Tong'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}]",[],248.0,0.0678634,The study consists of two independent and consecutive cohorts: original cohort (124 patients) and validation cohort (124 patients).,"[{'ForeName': 'Jia-Yun', 'Initials': 'JY', 'LastName': 'Lin', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Chi-Hao', 'Initials': 'CH', 'LastName': 'Zhang', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Hong-Jie', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Zhu', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ming-Zhe', 'Initials': 'MZ', 'LastName': 'Huang', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Sun-Hu', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Xiao-Liang', 'Initials': 'XL', 'LastName': 'Qi', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Hai-Zhong', 'Initials': 'HZ', 'LastName': 'Huo', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Hui-Song', 'Initials': 'HS', 'LastName': 'Chen', 'Affiliation': ""Gastroenterology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Xiao-Lou', 'Initials': 'XL', 'LastName': 'Lou', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China luosh9hospital@sina.com lou_xl@163.com.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': ""General Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China luosh9hospital@sina.com lou_xl@163.com.""}]",BMJ open,['10.1136/bmjopen-2018-028518']
1094,31771375,Influence of social support on asthma self-management in adolescents.,"Objective: Adolescents with asthma are influenced by peers and family. The objective was to better understand family social support and test its association with medication adherence, asthma control, and Emergency Department (ED) use. Methods: This study is a cross-sectional secondary data analysis from a randomized controlled trial with urban adolescents from three U.S. cities. Participants (12-20 years old) with asthma completed the Perceived Family Support Scale (PFS) and Horne's Medication Adherence Report Scale (MARS). Data from both tools were classified into 2 categories- high and low (< 25 th percentile) perceived family support and high (total score >10) and low medication adherence, respectively. Chi-square statistic and logistic regression were used for analysis. Results: Of the 371 participants, the majority were young (96% ≤ 17 years), African American or Bi-racial (85%), and Medicaid-insured (72%); over one-third had maternal family history of asthma. Among those on a controller medication ( n = 270), only 37% reported its use ≥8 days over 2 weeks. Asthma control was poor with 50% categorized ""not well controlled,"" 34% ""very poorly controlled."" Participants responded positively to most social support items. One item, providing and receiving social support to and from family members, was less often positively reported. Low medication adherence was significantly associated with lower perceived social support ( p = 0.018). Conclusion: This study underscores the importance of family social support in understanding the extent of adolescents' self-management, particularly medication adherence.",2019,Low medication adherence was significantly associated with lower perceived social support (p = 0.018). ,"['371 participants', 'adolescents', 'urban adolescents from three U.S. cities', 'majority were young (96% ≤ 17 years), African American or Bi-racial (85%), and Medicaid-insured (72%); over one-third had maternal family history of asthma', 'Participants (12-20 years old) with asthma completed the']",['family social support'],"['Low medication adherence', ""Perceived Family Support Scale (PFS) and Horne's Medication Adherence Report Scale (MARS""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1261327', 'cui_str': 'Family history of asthma'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037438'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0150232', 'cui_str': 'Family support (regime/therapy)'}, {'cui': 'C0222045'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",371.0,0.0221786,Low medication adherence was significantly associated with lower perceived social support (p = 0.018). ,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sloand', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Butz', 'Affiliation': 'Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Hyekyun', 'Initials': 'H', 'LastName': 'Rhee', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Walters', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Breuninger', 'Affiliation': 'Primary Care Pediatric Nurse Practitioner, Park Pediatrics, Takoma Park, MD, USA.'}, {'ForeName': 'Rosario Alejandra', 'Initials': 'RA', 'LastName': 'Pozzo', 'Affiliation': 'Pediatric Nurse Practitioner, East Pompano Pediatrics, Pompano Beach, FL, USA.'}, {'ForeName': 'Christina Marie', 'Initials': 'CM', 'LastName': 'Barnes', 'Affiliation': ""Pediatric Nurse Practitioner, Center for Colorectal and Pelvic Reconstruction, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Mona Newsome', 'Initials': 'MN', 'LastName': 'Wicks', 'Affiliation': 'Health Promotion and Disease Prevention Department, University of Tennessee Health Science Center, College of Nursing, Memphis, TN, USA.'}, {'ForeName': 'Laurene', 'Initials': 'L', 'LastName': 'Tumiel-Berhalter', 'Affiliation': 'Department of Family Medicine, Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2019.1698601']
1095,31162529,Association of Quetiapine Overuse Letters With Prescribing by Physician Peers of Targeted Recipients: A Secondary Analysis of a Randomized Clinical Trial.,,2019,,['Overuse Letters With Prescribing by Physician Peers of Targeted Recipients'],['Quetiapine'],[],"[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}]",[],,0.0526203,,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sacarny', 'Affiliation': 'Department of Health Policy and Management, Mailman School of Public Health, Columbia University, New York, New York.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Olenski', 'Affiliation': 'Department of Economics, Columbia University, New York, New York.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Barnett', 'Affiliation': 'Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.1418']
1096,31195244,Safety and efficacy of first-line smoking cessation pharmacotherapies in bipolar disorders: Subgroup analysis of a randomized clinical trial.,"OBJECTIVES
Post hoc analyses of EAGLES data to examine safety and efficacy of first-line smoking cessation pharmacotherapies in smokers with bipolar disorders (BD).
METHODS
Smokers with BD I/II (n = 285; 81.4% with BD I) and a comparison nonpsychiatric cohort (NPC; n = 2794) were randomly assigned to varenicline, bupropion, nicotine replacement therapy (NRT), or placebo for 12 weeks, plus weekly counseling. Primary outcomes were occurrence of moderate to severe neuropsychiatric adverse events (NPSAEs) and Weeks 9-12 biochemically-confirmed continuous abstinence (CA) rates.
RESULTS
For BD smokers, NPSAE risk differences versus placebo were: varenicline, 6.17 (95% CI: -7.84 to 20.18); bupropion, 4.09 (-8.82 to 16.99); NRT, -0.56 (-12.34 to 11.22). ORs for Weeks 9-12 CA, comparing active medication to placebo among BD smokers were: varenicline, 2.61 (0.68-9.95); bupropion, 1.29 (0.31-5.37), NRT, 0.71 (0.14-3.74). Pooling across treatments, NPSAE occurrence was higher (10.7% versus 2.3%; P < 0.001) and CA rates were lower (22.8% versus 13.3%; P = 0.008) in BD than NPC.
LIMITATIONS
Study not powered to detect differences in safety and efficacy in the BD subcohort; generalizability limited to stably treated BD without current substance use disorders.
CONCLUSIONS
Smokers with BD had higher risk of NPSAEs and were less likely to quit overall than NPC smokers. Among smokers with BD, NPSAE risk difference estimates for active treatments versus placebo ranged from 1% lower to 6% higher. Efficacy of varenicline in smokers with BD was similar to EAGLES main outcomes; bupropion and NRT effect sizes were descriptively lower. Varenicline may be a tolerable and effective cessation treatment for smokers with BD.
TRIAL REGISTRATION
ClinicalTrials.gov identifier (https://clinicaltrials.gov/): NCT01456936.",2019,"Pooling across treatments, NPSAE occurrence was higher (10.7% versus 2.3%; P < 0.001) and CA rates were lower (22.8% versus 13.3%; P = 0.008) in BD than NPC.
","['Smokers with BD I/II (n\u202f=\u202f285', 'bipolar disorders', 'smokers with BD', 'For BD smokers', 'smokers with bipolar disorders (BD']","['Varenicline', 'bupropion', 'placebo', 'varenicline', 'first-line smoking cessation pharmacotherapies', 'varenicline, bupropion, nicotine replacement therapy (NRT), or placebo']","['Efficacy', 'safety and efficacy', 'NPSAE occurrence', 'CA rates', 'occurrence of moderate to severe neuropsychiatric adverse events (NPSAEs) and Weeks 9-12 biochemically-confirmed continuous abstinence (CA) rates', 'Safety and efficacy']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0013216', 'cui_str': 'Pharmacotherapy'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]",2794.0,0.13284,"Pooling across treatments, NPSAE occurrence was higher (10.7% versus 2.3%; P < 0.001) and CA rates were lower (22.8% versus 13.3%; P = 0.008) in BD than NPC.
","[{'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-B232; PO Box 19024; Seattle, WA 98109, USA. Electronic address: jheffner@fredhutch.org.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Russ', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Ayers', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Lisa St', 'Initials': 'LS', 'LastName': 'Aubin', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Krishen', 'Affiliation': 'PAREXEL International on behalf of GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'University College, London, UK.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Anthenelli', 'Affiliation': 'University of California, San Diego, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2019.06.008']
1097,31361922,"Prolonged Effect of Zoledronic Acid on Bone Mineral Density and Turnover in HIV-Infected Adults on Tenofovir: A Randomized, Open-Label Study.","Zoledronic acid (ZOL) 5 mg annually was more effective than tenofovir disoproxil fumarate (TDF) switching at increasing bone mineral density (BMD) over 24 months in HIV-infected, osteopenic adults. To determine whether the effects of ZOL would persist without further infusions, we compared changes in left hip and spine BMD over 36 months in participants randomized to ZOL 5 mg at baseline and month 12 (and to continue TDF) or to switch TDF (without receiving ZOL). We also compared changes in the plasma bone turnover markers (BTMs) C-terminal telopeptide of type 1 collagen (CTX; bone resorption), and procollagen type 1 N propeptide (P1NP; bone formation) and determined whether CTX and P1NP changes at month 3 predicted BMD changes at month 36. Changes were compared in the per-protocol populations, which included 32 (74%) of 43 participants randomized to ZOL and 37 (88%) of 42 participants who switched TDF. Despite not receiving ZOL after month 12, mean hip and spine BMD change from baseline were stable and remained greater with ZOL at month 36 than with TDF switching (spine: 7.5% versus 2.7%, mean difference 4.7%, p < 0.001; hip: 5.5% versus 1.5%, mean difference 4.0%, p < 0.001). CTX and P1NP levels declined in both groups but significantly more with ZOL. Only percent changes in P1NP at month 3 correlated inversely with BMD changes at month 36 (spine: rho = -0.442, p < 0.001; hip: rho = -0.373, p = 0.002). Two infusions of ZOL (in the presence of ongoing TDF) yielded sustained BMD increases through month 36 that remained greater than with TDF switching. © 2019 American Society for Bone and Mineral Research.",2019,"Despite not receiving ZOL after Month 12, mean hip and spine BMD change from baseline were stable and remained greater with ZOL at Month 36 than with TDF switching (spine: 7.5% vs 2.7%, mean difference 4.7%,",['HIV-infected adults on'],"['tenofovir', 'ZOL', 'switch TDF (without receiving ZOL', 'tenofovir disoproxil fumarate (TDF) switching', 'Zoledronic acid (ZOL', 'zoledronic acid']","['sustained BMD', 'mean hip and spine BMD change', 'CTX and P1NP levels', 'bone mineral density (BMD', 'BMD changes', 'bone mineral density and turnover', 'left hip and spine BMD', 'plasma bone turnover markers (BTMs']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}]",43.0,0.0517675,"Despite not receiving ZOL after Month 12, mean hip and spine BMD change from baseline were stable and remained greater with ZOL at Month 36 than with TDF switching (spine: 7.5% vs 2.7%, mean difference 4.7%,","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': ""Centre for Applied Medical Research, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kerr', 'Affiliation': ""Centre for Applied Medical Research, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Richardson', 'Affiliation': ""Centre for Applied Medical Research, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pocock', 'Affiliation': ""Department of Nuclear Medicine, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Jhon', 'Initials': 'J', 'LastName': 'Rojas', 'Affiliation': 'Infectious Diseases Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Infectious Diseases Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hoy', 'Affiliation': 'Department of Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3834']
1098,31794624,Association of Receipt of a Housing Voucher With Subsequent Hospital Utilization and Spending.,"Importance
Although neighborhoods are thought to be an important health determinant, evidence for the relationship between neighborhood poverty and health care use is limited, as prior studies have largely used observational data without an experimental design.
Objective
To examine whether housing policies that reduce exposure to high-poverty neighborhoods were associated with differences in long-term hospital use among adults and children.
Design, Setting, and Participants
Exploratory analysis of the Moving to Opportunity for Fair Housing Demonstration Program, a randomized social experiment conducted in 5 US cities. From 1994 to 1998, 4604 families in public housing were randomized to 1 of 3 groups: a control condition, a traditional Section 8 voucher toward rental costs in the private market, or a voucher that could only be used in low-poverty neighborhoods. Participants were linked to all-payer hospital discharge data (1995 through 2014 or 2015) and Medicaid data (1999 through 2009). The final follow-up date ranged from 11 to 21 years after randomization.
Exposures
Receipt of a traditional or low-poverty voucher vs control group.
Main Outcomes and Measures
Rates of hospitalizations and hospital days, and hospital spending.
Results
Among 4602 eligible individuals randomized as adults, 4072 (88.5%) were linked to health data (mean age, 33 years [SD, 9.0 years]; 98% female; median follow-up, 11 years). There were no significant differences in primary outcomes among adults randomized to receive a voucher compared with the control group (unadjusted hospitalization rate, 14.0 vs 14.7 per 100 person-years, adjusted incidence rate ratio [IRR], 0.95 [95% CI, 0.84-1.08; P = .45]; hospital days, 62.8 vs 67.0 per 100 person-years; IRR, 0.93 [95% CI, 0.77-1.13; P = .46]; yearly spending, $2075 vs $1977; adjusted difference, -$129 [95% CI, -$497 to $239; P = .49]). Among 11 290 eligible individuals randomized as children, 9118 (80.8%) were linked to health data (mean age, 8 years [SD, 4.6 years]; 49% female; median follow-up, 11 years). Receipt of a housing voucher during childhood was significantly associated with lower hospitalization rates (6.3 vs 7.3 per 100 person-years; IRR, 0.85 [95% CI, 0.73-0.99; P = .03]) and yearly inpatient spending ($633 vs $785; adjusted difference, -$143 [95% CI, -$256 to -$31; P = .01]) and no significant difference in hospital days (25.7 vs 28.8 per 100 person-years; IRR, 0.92 [95% CI, 0.77-1.11; P = .41]).
Conclusions and Relevance
In this exploratory analysis of a randomized housing voucher intervention, adults who received a housing voucher did not experience significant differences in hospital use or spending. Receipt of a voucher during childhood was significantly associated with lower rates of hospitalization and less inpatient spending during long-term follow-up.",2019,"There were no significant differences in primary outcomes among adults randomized to receive a voucher compared with the control group (unadjusted hospitalization rate, 14.0 vs 14.7 per 100 person-years, adjusted incidence rate ratio [IRR], 0.95 [95% CI, 0.84-1.08; P = .45]; hospital days, 62.8 vs 67.0 per 100 person-years; IRR, 0.93","['Participants were linked to all-payer hospital discharge data (1995 through 2014 or 2015) and Medicaid data (1999 through 2009', 'From 1994 to 1998, 4604 families in public housing', 'Among 11\u202f290 eligible individuals randomized as children, 9118 (80.8%) were linked to health data (mean age, 8 years [SD, 4.6 years]; 49% female; median follow-up, 11 years', '4602 eligible individuals randomized as adults, 4072 (88.5%) were linked to health data (mean age, 33 years [SD, 9.0 years]; 98% female; median follow-up, 11 years', 'adults and children']","['control condition, a traditional Section 8 voucher toward rental costs in the private market, or a voucher that could only be used in low-poverty neighborhoods', 'traditional or low-poverty voucher vs control group']","['hospital days', 'yearly inpatient spending', 'hospitalization rate', 'hospitalization rates', 'Measures\n\n\nRates of hospitalizations and hospital days, and hospital spending', 'hospital use or spending']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0034028', 'cui_str': 'Public Housing'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.183484,"There were no significant differences in primary outcomes among adults randomized to receive a voucher compared with the control group (unadjusted hospitalization rate, 14.0 vs 14.7 per 100 person-years, adjusted incidence rate ratio [IRR], 0.95 [95% CI, 0.84-1.08; P = .45]; hospital days, 62.8 vs 67.0 per 100 person-years; IRR, 0.93","[{'ForeName': 'Craig Evan', 'Initials': 'CE', 'LastName': 'Pollack', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Blackford', 'Affiliation': 'Department of Oncology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Analysis Group, New York, New York.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Deluca', 'Affiliation': 'Department of Sociology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Rachel L J', 'Initials': 'RLJ', 'LastName': 'Thornton', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Herring', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",JAMA,['10.1001/jama.2019.17432']
1099,31237045,Walking with rhythmic auditory stimulation in chronic patients after stroke: A pilot randomized controlled trial.,"OBJECTIVES
There is a lack of studies that evaluate the effects of different gait training (GT) interventions for patients after stroke in an outpatient setting. The aim of the present trial therefore was to evaluate the effects of two different outpatient GT programmes after chronic stroke.
METHODS
We randomly allocated patients into two groups of either a 4-week overground GT with rhythmic auditory stimulation (RAS, n = 6) of 30 min, three times a week over 4 weeks or an overground GT without RAS (GT, n = 6) with same duration and intensity. Primary outcomes were walking velocity and capacity; secondary outcomes were the Berg Balance Scale (BBS) and stride length before and after interventions and at 12 weeks follow-up.
RESULTS
Twelve patients after stroke (nine females; mean [SD] age 67 [9] years; duration of illness 67 [69] months; all left-sided strokes) were included. Patients improved their walking velocity from baseline until the end of GT (RAS: median difference 0.05 m/s [interquartile range, IQR 0.06] and GT: 0.12 m/s [0.29]) and walking capacity (RAS: median difference 14 m [IQR 14] and GT: 41 m [79]). However, RAS and GT did not differ significantly (p = .30 and p = .30, respectively). Patients improved from baseline until the end of intervention in BBS (RAS: median difference 4 points [IQR 4] and GT: 1 point [3]) and stride length (RAS: median difference 6.3 cm [IQR 12.1] and GT: 5.5 cm [8.8]). However, BBS and stride length did not differ significantly between groups (p = .08 and p = .58, respectively).
CONCLUSION
Walking with rhythmic auditory stimulation in chronic patients after stroke does not provide a beneficial effect on walking when compared with walking without rhythmic auditory stimulation.",2020,Walking with rhythmic auditory stimulation in chronic patients after stroke does not provide a beneficial effect on walking when compared with walking without rhythmic auditory stimulation.,"['chronic patients after stroke', 'Twelve patients after stroke (nine females; mean [SD] age 67 [9] years; duration of illness 67 [69] months; all left-sided strokes) were included', 'patients after stroke in an outpatient setting']","['4-week overground GT with rhythmic auditory stimulation (RAS, n\xa0=\xa06) of 30\xa0min, three times a week over 4\xa0weeks or an overground GT without RAS', 'gait training (GT) interventions', 'Walking with rhythmic auditory stimulation']","['walking capacity', 'stride length', 'walking velocity', 'BBS and stride length', 'walking velocity and capacity; secondary outcomes were the Berg Balance Scale (BBS) and stride length']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443246', 'cui_str': 'Left sided (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",,0.279113,Walking with rhythmic auditory stimulation in chronic patients after stroke does not provide a beneficial effect on walking when compared with walking without rhythmic auditory stimulation.,"[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Elsner', 'Affiliation': 'Department of Public Health, Medical School, Technical University Dresden, Dresden, Germany.'}, {'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Schöler', 'Affiliation': 'Department of Physiotherapy, SRH University of Applied Health Sciences, Gera, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kon', 'Affiliation': 'Department of Physiotherapy, SRH University of Applied Health Sciences, Gera, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrholz', 'Affiliation': 'Department of Public Health, Medical School, Technical University Dresden, Dresden, Germany.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1800']
1100,31195357,"Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial.","BACKGROUND
In the phase III CheckMate 227 study, first-line nivolumab + ipilimumab significantly prolonged progression-free survival (co-primary end-point) versus chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) and high tumour mutational burden (TMB; ≥10 mutations/megabase).
AIM
To evaluate patient-reported outcomes (PROs) in this population.
METHODS
Disease-related symptoms and general health status were assessed using the validated PRO questionnaires Lung Cancer Symptom Scale (LCSS) and EQ-5D, respectively. LCSS average symptom burden index (ASBI) and three-item global index (3-IGI) and EQ-5D visual analogue scale (VAS) and utility index (UI) scores and changes from baseline were analysed descriptively. Longitudinal changes were assessed by mixed-effect model repeated measures (MMRMs) and time to first deterioration/improvement analyses.
RESULTS
In the high TMB population, PRO questionnaire completion rates were ∼90% at baseline and >80% for most on-treatment assessments. During treatment, mean changes from baseline with nivolumab + ipilimumab showed early, clinically meaningful improvements in LCSS ASBI/3-IGI and EQ-5D VAS/UI; with chemotherapy, symptoms and health-related quality of life remained stable (LCSS ASBI/3-IGI, EQ-5D UI) or improved following induction (EQ-5D VAS). MMRM-assessed changes in symptom burden were improved with nivolumab + ipilimumab versus chemotherapy. Symptom deterioration by week 12 was lower with nivolumab + ipilimumab versus chemotherapy (22.3% versus 35.0%; absolute risk reduction: 12.7% [95% confidence interval 2.4-22.5]), irrespective of discontinuation. Time to first deterioration was delayed with nivolumab + ipilimumab versus chemotherapy across LCSS and EQ-5D summary measures.
CONCLUSION
First-line nivolumab + ipilimumab demonstrated early, sustained improvements in PROs versus chemotherapy in patients with advanced NSCLC and high TMB.
CLINICAL TRIAL REGISTRATION
NCT02477826.",2019,"Time to first deterioration was delayed with nivolumab + ipilimumab versus chemotherapy across LCSS and EQ-5D summary measures.
","['patients with advanced non-small-cell lung cancer (NSCLC) and high tumour mutational burden (TMB; ≥10 mutations/megabase', 'advanced non-small-cell lung cancer with high tumour mutational burden', 'patients with advanced NSCLC and high TMB']","['Nivolumab plus ipilimumab versus chemotherapy', 'chemotherapy']","['PRO questionnaire completion rates', 'progression-free survival', 'MMRM-assessed changes in symptom burden', 'utility index (UI) scores', 'LCSS ASBI/3-IGI and EQ-5D VAS/UI; with chemotherapy, symptoms and health-related quality of life remained stable (LCSS ASBI/3-IGI, EQ-5D UI', 'Symptom deterioration', 'LCSS average symptom burden index (ASBI) and three-item global index (3-IGI)\xa0and EQ-5D visual analogue scale (VAS) and', 'validated PRO questionnaires Lung Cancer Symptom Scale (LCSS) and EQ-5D, respectively']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1533164', 'cui_str': 'Megabase'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0222045'}]",,0.0904609,"Time to first deterioration was delayed with nivolumab + ipilimumab versus chemotherapy across LCSS and EQ-5D summary measures.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Wöhrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'Centrul de Oncologie Sf Nectarie, 23A Caracal St, Craiova, 200347, Romania. Electronic address: mike_schenker@yahoo.com.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, 776, 1 Sunhwan-ro, Seowon-gu, Cheongju-si, Chungcheonbuk-do, 28644, South Korea. Electronic address: kihlee@chungbuk.ac.kr.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Provencio', 'Affiliation': 'Universidad Autónoma de Madrid, Instituto de Investigación Puerta de Hierro, Hospital Puerta de Hierro de Majadahonda, C / Manuel de Falla 1, Madrid, Majadahonda, 28222, Spain. Electronic address: mprovenciop@gmail.com.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Tokyo, Koto-ku, 135-8550, Japan. Electronic address: mnishio@jfcr.or.jp.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Lesniewski-Kmak', 'Affiliation': 'Oddzial Onkologii Radioterapii Szpital/Gdansk Medical University, UI. Powstania Styczniowego 1, Gdynia, 81-519, Poland. Electronic address: krzychu03@hotmail.com.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Sangha', 'Affiliation': 'Cross Cancer Institute, 11560 University Ave, Edmonton, Alberta, T6G 1Z2, Canada. Electronic address: randeep.sangha@albertahealthservices.ca.'}, {'ForeName': 'Samreen', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Department of Infection, Leicester, Leicestershire, LE1 5WW, UK. Electronic address: samreen.ahmed@uhl-tr.nhs.uk.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Raimbourg', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Centre Rene Gauducheau, Boulevard Jacques Monod, 44805 Nantes-Saint Herblain Cedex, France. Electronic address: judith.raimbourg@ico.unicancer.fr.""}, {'ForeName': 'Kynan', 'Initials': 'K', 'LastName': 'Feeney', 'Affiliation': 'Notre Dame University and Edith Cowan University, 100 Murdoch Drive, Murdoch, Perth, Western Australia, 6150, Australia. Electronic address: kynan@oncowest.com.au.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Corre', 'Affiliation': 'CHU de Rennes, 2 Rue Henri le Guilloux, Rennes, 35033, France. Electronic address: romain.corre@chu-rennes.fr.'}, {'ForeName': 'Fabio Andre', 'Initials': 'FA', 'LastName': 'Franke', 'Affiliation': 'CACON, Hospital de Caridade de Ijuí, Av David Jose Martins, Centro, Ijuí, Rio Grande do Sul, 98700-000, Brazil. Electronic address: ff.oncosite@gmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Richardet', 'Affiliation': 'IONC - Universidad Católica de Córdoba, Parana 560. 2 Piso, Cordoba, 5000, Argentina. Electronic address: eduardorichardet@gmail.com.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Penrod', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA. Electronic address: john.penrod@bms.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA. Electronic address: yong.yuan@bms.com.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Nathan', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA. Electronic address: faith.nathan@bms.com.'}, {'ForeName': 'Prabhu', 'Initials': 'P', 'LastName': 'Bhagavatheeswaran', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA. Electronic address: prabhu.bhagavatheeswaran@bms.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DeRosa', 'Affiliation': 'Adelphi Values, 290 Congress Street 7th Floor, Boston, MA, 02210, USA. Electronic address: michael.derosa@adelphivalues.com.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Taylor', 'Affiliation': 'Adelphi Values, 290 Congress Street 7th Floor, Boston, MA, 02210, USA. Electronic address: fiona.taylor@adelphivalues.com.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Lawrance', 'Affiliation': 'Adelphi Values, Adelphi Mill, Grimshaw Ln, Bollington, Cheshire, SK10 5JB, UK. Electronic address: rachael.lawrance@adelphivalues.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, CRB1-G94, Baltimore, MD, 21287, USA. Electronic address: brahmju@jhmi.edu.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.05.008']
1101,31169862,Patient-Reported Visual Function Outcomes After Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion: Preplanned Secondary Analysis of a Randomized Clinical Trial.,"Importance
Anti-vascular endothelial growth factor (anti-VEGF) therapy is the standard-of-care first-line treatment for macular edema associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), and information is needed to assess the effect of anti-VEGF therapy on patient-reported visual function.
Objective
To investigate the effect of intravitreal aflibercept or bevacizumab on patient-reported visual function in patients with macular edema secondary to CRVO or HRVO.
Design, Setting, and Participants
This preplanned secondary analysis of the Study of Comparative Treatments for Retinal Vein Occlusion 2, a randomized clinical trial, included 346 participants from 66 private practice or academic centers in the United States. Participants had CRVO- or HRVO-associated macular edema and month 6 outcome information. Data were collected from September 17, 2014, through November 18, 2015, and analyzed from February 7, 2018, through February 26, 2019.
Interventions
Eyes were randomly assigned to receive an intravitreal injection of bevacizumab (1.25 mg) or aflibercept (2.0 mg) at baseline and every 4 weeks through month 5.
Main Outcomes and Measures
Difference between treatment arms at month 6 in the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite and subscale scores.
Results
Among the 346 participants (56.1% men; mean [SD] age, 69 [12] years), significant improvements occurred from baseline to month 6 in the NEI VFQ-25 composite score in the aflibercept (mean [SE] change, 7.5 [0.9]; P < .001) and bevacizumab (mean [SE], 6.1 [0.9]; P < .001) arms and in 10 of 12 subscale scores after multiplicity adjustment. No differences were observed at month 6 in NEI VFQ-25 composite or subscale scores between participants randomized to aflibercept or bevacizumab treatment. Weak positive correlations were seen between the change in the study eyes' visual acuity and the changes in the NEI VFQ-25 composite score (r = 0.22; P < .001) and the Distance Activities (r = 0.24; P < .001) and Driving (r = 0.19; P = .03) subscale scores.
Conclusions and Relevance
Significant improvement occurred from baseline to month 6 in patient-reported visual function as assessed by the NEI VFQ-25. The lack of difference in NEI VFQ-25 scores between study participants treated with monthly intravitreal aflibercept and bevacizumab for macular edema due to CRVO or HRVO at month 6 is consistent with the primary outcome finding that showed bevacizumab was noninferior to aflibercept with respect to visual acuity improvement from baseline to month 6.
Trial Registration
ClinicalTrials.gov identifier: NCT01969708.",2019,No differences were observed at month 6 in NEI VFQ-25 composite or subscale scores between participants randomized to aflibercept or bevacizumab treatment.,"['patients with macular edema secondary to CRVO or HRVO', 'Interventions\n\n\nEyes', 'macular edema associated with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO', 'Data were collected from September 17, 2014, through November 18, 2015, and analyzed from February 7, 2018, through February 26, 2019', 'Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion', '346 participants from 66 private practice or academic centers in the United States', '346 participants (56.1% men; mean [SD] age, 69 [12] years']","['intravitreal injection of bevacizumab', 'bevacizumab', 'intravitreal aflibercept or bevacizumab', 'Importance\n\n\nAnti-vascular endothelial growth factor (anti-VEGF) therapy', 'Anti-Vascular Endothelial Growth Factor Therapy', 'aflibercept']","['25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite and subscale scores', 'Visual Function Outcomes', 'visual acuity', 'NEI VFQ-25 composite or subscale scores', 'visual function', 'CRVO- or HRVO-associated macular edema', 'NEI VFQ-25 composite score', 'visual acuity improvement', 'NEI VFQ-25 scores', 'Distance Activities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion (disorder)'}, {'cui': 'C1735356', 'cui_str': 'Hemiretinal vein occlusion'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",346.0,0.218978,No differences were observed at month 6 in NEI VFQ-25 composite or subscale scores between participants randomized to aflibercept or bevacizumab treatment.,"[{'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'VanVeldhuisen', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Barton', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Oden', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Eye Institute, University of California, Los Angeles.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Blodi', 'Affiliation': 'University of Wisconsin Fundus Photograph Reading Center, Madison.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Worrall', 'Affiliation': 'Retina Centers, PC, Tucson, Arizona.'}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Fish', 'Affiliation': 'Texas Retina Associates, Dallas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.1519']
1102,31142530,Auricular points acupressure for insulin resistance in overweight/obese women with polycystic ovary syndrome: protocol for a randomised controlled pilot trial.,"INTRODUCTION
Approximately 5%-20% of reproductive women suffer from polycystic ovary syndrome (PCOS). Auricular points acupressure (AA) may serve as alternative management for PCOS for its benefits in both physical and psychological well-being. However, the effects of AA for insulin resistance (IR) in overweight/obese PCOS women have not been confirmed.
METHODS AND ANALYSIS
The present study is designed as a randomised, placebo-controlled pilot trial to evaluate the effectiveness and safety of AA in treating IR in women with PCOS. A total of 60 eligible PCOS subjects will be randomised into an intervention group (AA group) and a control group (sham AA group) in a ratio of 1:1. Magnetic beads will be taped to the auricular points by the same senior acupuncture specialist from the First Affiliated Hospital, Heilongjiang University of Chinese Medicine. The treatment will last for 12 weeks. Primary outcome measure will be changes in homeostasis model assessment of IR between baseline and after 3 months of AA/sham AA treatment. Secondary outcomes include hormonal profile, weight, waist/hip circumference, body mass index, blood pressure, Ferriman-Gallwey score, acne and the assessment of health-related quality of life. Outcome measures are collected at baseline and the end of treatment visit.
ETHICS AND DISSEMINATION
The protocol has been approved by the ethics committee of the First Affiliated Hospital of Heilongjiang University of Chinese Medicine (HZYLLKY201800301). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.
TRIAL REGISTRATION NUMBER
NCT03546595; Pre-results.",2019,A total of 60 eligible PCOS subjects will be randomised into an intervention group (AA group) and a control group (sham AA group) in a ratio of 1:1.,"['women with PCOS', 'overweight/obese women with polycystic ovary syndrome', 'overweight/obese PCOS women', 'reproductive women suffer from polycystic ovary syndrome (PCOS', '60 eligible PCOS subjects']","['control group (sham AA', 'placebo', 'Auricular points acupressure (AA', 'Auricular points acupressure']","['changes in homeostasis model assessment of IR', 'hormonal profile, weight, waist/hip circumference, body mass index, blood pressure, Ferriman-Gallwey score, acne and the assessment of health-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",60.0,0.352374,A total of 60 eligible PCOS subjects will be randomised into an intervention group (AA group) and a control group (sham AA group) in a ratio of 1:1.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Yingji', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Pharmacy, Harbin Medical University, Harbin, China.'}, {'ForeName': 'Liangzhen', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Meiwei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Zimeng', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Yicheng', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': 'Qiqihar Traditional Chinese Medicine Hospital, Qiqihar, China.'}, {'ForeName': 'Songjiang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}]",BMJ open,['10.1136/bmjopen-2018-027498']
1103,29172862,Comparison of Two Methods: Spinal Anesthesia and Ischiorectal Block on Post Hemorrhoidectomy Pain and Hospital Stay: A Randomized Control Trial.,"OBJECTIVE
Hemorrhoidectomy is one of the most common hemorrhoid surgery. Many areas are innervated by nerves, and this makes the surgery to be very painful. Various anesthetic methods have been proposed, and the number of investigations and procedures demonstrated the absence of a reliable method for reducing pain. This study compares the cavity ischiorectal block with spinal anesthesia in reducing postoperative pain, analgesic consumption, and hospital stay.
RESEARCH DESIGN
This study is a randomized control trial carried out on seventy patients sampled. Thirty-five (35) among them were placed in spinal anesthesia group, and the other 35 were placed in the ischiorectal block group. According to the study, questionnaire was designed in such a way that postoperative variables such as postoperative pain, analgesic consumption, changes in blood pressure, heart rate and hospital stay in both groups were evaluated and compared.
CLINICAL TRIAL REGISTRATION
IRCT2015111616516N3 ( http://en.search.irct.ir/search?query=IRCT2015111616516N3 ) Results: In this study, the pain scores on Visual Analogue Scale (VAS) at 0, 6, 12, and 24 hr for spinal anesthesia group after surgery were 0, 3.08 ± 0.78, 2.05 ± 1.02, 1.11 ± 0.83, respectively (p < 0.05). That of ischiorectal blocks were 0.98 ± 0.25, 1.57 ± 0.81, 0.91 ± 0.91, and 0.63 ± 0.31 respectively, which indicated lesser pain after surgery in the ischiorectal block at 6, 12, and 24 hr. In this study, out of the 35 patients that underwent spinal anesthesia, 28 patients (80%) were hospitalized in the first 6 hr, 13 patients (37.1%) in the second 6 hr, 3 patients (8.6%) in the second 12 hr after surgery. For patients under the ischiorectal block, the number of patients hospitalized were 13 patients (37.1%), in the first 6 hr, 4 patients (11.4%) in the second 6 hr, and 1 (2.9%) were hospitalized in the second 12 hr after surgery (p < 0.05).
CONCLUSION
Ischiorectal blocks causes less pain, require fewer painkillers, and reduces the hospital stay after surgery than spinal anesthesia.",2018,"CONCLUSION
Ischiorectal blocks causes less pain, require fewer painkillers, and reduces the hospital stay after surgery than spinal anesthesia.","['seventy patients sampled', '35 patients that underwent spinal anesthesia, 28 patients (80%) were hospitalized in the first 6\xa0hr, 13 patients (37.1%) in the second 6\xa0hr, 3 patients (8.6%) in the second 12\xa0hr after surgery']","['spinal anesthesia', 'Spinal Anesthesia and Ischiorectal Block']","['pain scores on Visual Analogue Scale (VAS', 'pain', 'Stay', 'hospital stay', 'postoperative pain, analgesic consumption, and hospital stay', 'Post Hemorrhoidectomy Pain and Hospital', 'postoperative pain, analgesic consumption, changes in blood pressure, heart rate and hospital stay']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",70.0,0.0380883,"CONCLUSION
Ischiorectal blocks causes less pain, require fewer painkillers, and reduces the hospital stay after surgery than spinal anesthesia.","[{'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Nadri', 'Affiliation': 'a Department of Anesthesiology , Lorestan University of Medical Sciences , Khorramabad , Iran.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Mahmoudvand', 'Affiliation': 'b Department of Surgery , Lorestan University of Medical Sciences , Khorramabad , Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Rokrok', 'Affiliation': 'c Student of Committee Research, Lorestan University of Medical Sciences , Khorramabad , Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'd Department of Epidemiology and Biostatistics , School of Public Health, Lorestan University of Medical Sciences , Khorramabad , Iran.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2017.1349221']
1104,30891845,Pace capture and adenosine triphosphate provocation are complementary rather than mutually exclusive methods to ensure durable pulmonary vein isolation.,"INTRODUCTION
Adenosine triphosphate (ATP)-provoked dormant conduction (DC) and pacing for unexcitability are used to identify conduction gaps along the ablation lines after circumferential pulmonary vein isolation (CPVI). We aim to determine whether ATP provocation and pacing are interchangeable as endpoints for ablation of paroxysmal atrial fibrillation (PAF).
METHODS AND RESULTS
A total of 107 patients with PAF were randomly divided into two groups after completion of CPVI. In group I (A-P group, n = 53), ATP was administered first. If DC was uncovered, additional ablation was performed until ATP tests were negative. Bipolar pacing along the ablation line was performed subsequently. In group II (P-A group, n = 54), the same protocol was used, but the pacing and the ATP tests were performed in the opposite sequence. The 12-month ablation outcomes of all patients were compared with those of a historical control group of 107 patients with PAF in whom only ATP test was performed. Regardless of which test was performed first, the other modality still identified conduction gaps. In group I, pacing maneuvers identified gaps in 49% (n = 26) of patients who had negative ATP tests. In group II, ATP tests uncovered DC in 18.5% (n = 10) of patients in whom pacing identified no gaps. After 12 months, a higher proportion of patients (91.6%) were free from atrial tachyarrhythmias compared with the historical control group (81.3%; P = 0.031).
CONCLUSION
Pacing along the ablation lines and ATP provocation are complementary tests for evaluating the durability of CPVI and can lead to better long-term outcomes when used in combination.",2019,"In group I, pacing maneuvers identified gaps in 49% (n = 26) of patients who had negative ATP tests.","['107 patients with PAF in whom only ATP test was performed', '107 patients with PAF']","['ATP provocation and pacing', 'Adenosine triphosphate (ATP)-provoked dormant conduction (DC) and pacing', 'CPVI']",['free from atrial tachyarrhythmias'],"[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0449428', 'cui_str': 'Provocation (attribute)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}]","[{'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}]",107.0,0.0150247,"In group I, pacing maneuvers identified gaps in 49% (n = 26) of patients who had negative ATP tests.","[{'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Zeng', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan-Jiang', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xian-Dong', 'Initials': 'XD', 'LastName': 'Yin', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao-Qing', 'Initials': 'XQ', 'LastName': 'Liu', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xin-Chun', 'Initials': 'XC', 'LastName': 'Yang', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xing-Peng', 'Initials': 'XP', 'LastName': 'Liu', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13901']
1105,31170114,Home Biofeedback for the Treatment of Dyssynergic Defecation: Does It Improve Quality of Life and Is It Cost-Effective?,"OBJECTIVES
Biofeedback therapy, whether administered at home or in office settings, is effective for dyssynergic defecation (DD). Whether home biofeedback improves quality of life (QOL) and is cost-effective when compared with office biofeedback is unknown.
METHODS
QOL was assessed in 8 domains (SF-36) at baseline and after treatment (3 months), alongside economic evaluation during a randomized controlled trial (RCT) comparing home and office biofeedback in patients with DD (Rome III). Costs related to both biofeedback programs were estimated from the hospital financial records, study questionnaires, and electronic medical records. A conversion algorithm (Brazier) was used to calculate the patient's quality-adjusted life years (QALYs) from SF-36 responses. Cost-effectiveness was expressed as incremental costs per QALY between the treatment arms.
RESULTS
One hundred patients (96 female patients, 50 in each treatment arm) with DD participated. Six of the 8 QOL domains improved (P < 0.05) in office biofeedback, whereas 4 of the 8 domains improved (P < 0.05) in home biofeedback; home biofeedback was noninferior to office biofeedback. The median cost per patient was significantly lower (P < 0.01) for home biofeedback ($1,112.39; interquartile range (IQR), $826-$1,430) than for office biofeedback ($1,943; IQR, $1,622-$2,369), resulting in a cost difference of $830.11 The median QALY gained during the trial was 0.03 for office biofeedback and 0.07 for home biofeedback (P = NS). The incremental cost-effectiveness ratio was $20,752.75 in favor of home biofeedback.
DISCUSSION
Biofeedback therapy significantly improves QOL in patients with DD regardless of home or office setting. Home biofeedback is a cost-effective treatment option for DD compared with office biofeedback, and it offers the potential of treating many more patients in the community.",2019,"The median cost per patient was significantly lower (P < 0.01) for home biofeedback ($1,112.39; interquartile range (IQR), $826-$1,430) than for office biofeedback ($1,943; IQR, $1,622-$2,369), resulting in a cost difference of $830.11 The median QALY gained during the trial was 0.03 for office biofeedback and 0.07 for home biofeedback (P = NS).","['patients with DD (Rome III', 'One hundred patients (96 female patients, 50 in each treatment arm) with DD participated', 'Dyssynergic Defecation', 'patients with DD regardless of home or office setting']","['Home Biofeedback', 'Biofeedback therapy']","['QOL', 'incremental cost-effectiveness ratio', 'Quality of Life', 'Cost-effectiveness', 'quality of life (QOL', 'median cost per patient']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0493554,"The median cost per patient was significantly lower (P < 0.01) for home biofeedback ($1,112.39; interquartile range (IQR), $826-$1,430) than for office biofeedback ($1,943; IQR, $1,622-$2,369), resulting in a cost difference of $830.11 The median QALY gained during the trial was 0.03 for office biofeedback and 0.07 for home biofeedback (P = NS).","[{'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Augusta University, Medical College of Georgia, Augusta, Georgia, USA.'}, {'ForeName': 'Jorge T', 'Initials': 'JT', 'LastName': 'Go', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Valestin', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City, Iowa, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Avalon Health Economics, LLC, Morristown, New Jersey, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000278']
1106,31658058,Concentration-Dependent Activity of Hydromethylthionine on Cognitive Decline and Brain Atrophy in Mild to Moderate Alzheimer's Disease.,"BACKGROUND
Although hydromethylthionine is a potent tau aggregation inhibitor, no difference was found in either of two Phase III trials in mild to moderate Alzheimer's disease (AD) comparing doses in the range 150-250 mg/day with 8 mg/day intended as a control.
OBJECTIVE
To determine how drug exposure is related to treatment response.
METHODS
A sensitive plasma assay for the drug was used in a population pharmacokinetic analysis of samples from 1,162 of the 1,686 patients who participated in either of the Phase III trials with available samples and efficacy outcome data.
RESULTS
There are steep concentration-response relationships for steady state plasma levels in the range 0.3-0.8 ng/ml at the 8 mg/day dose. Using a threshold based on the lower limit of quantitation of the assay on Day 1, there are highly significant differences in cognitive decline and brain atrophy in patients with above threshold plasma levels, both for monotherapy and add-on therapy, but with effect sizes reduced by half as add-on. Plasma concentrations in the range 4-21 ng/ml produced by the high doses are not associated with any additional benefit.
CONCLUSIONS
Hydromethylthionine has pharmacological activity on brain structure and function at the 8 mg/day dose as monotherapy or as add-on to symptomatic treatments. This combined with a plateau at higher doses is consistent with the lack of dose-response seen in the Phase III trials. Treatment benefit is predicted to be maximal at 16 mg/day as monotherapy. A placebo-controlled trial in mild/moderate AD is now ongoing to confirm efficacy at this dose.",2019,"Plasma concentrations in the range 4-21 ng/ml produced by the high doses are not associated with any additional benefit.
","[""Mild to Moderate Alzheimer's Disease"", 'population pharmacokinetic analysis of samples from 1,162 of the 1,686 patients who participated in either of the Phase III trials with available samples and efficacy outcome data']","['placebo', 'hydromethylthionine', 'Hydromethylthionine']","['steep concentration-response relationships for steady state plasma levels', 'cognitive decline and brain atrophy', 'Plasma concentrations']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}]",1686.0,0.0767765,"Plasma concentrations in the range 4-21 ng/ml produced by the high doses are not associated with any additional benefit.
","[{'ForeName': 'Bjoern O', 'Initials': 'BO', 'LastName': 'Schelter', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Shiells', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Baddeley', 'Affiliation': 'Department of Chemistry, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Rubino', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ganesan', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hammel', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Vuksanovic', 'Affiliation': 'Aberdeen Biomedical Imaging Center, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Roger T', 'Initials': 'RT', 'LastName': 'Staff', 'Affiliation': 'Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Aberdeen Biomedical Imaging Center, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bracoud', 'Affiliation': 'Bioclinica, Lyon, France.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Riedel', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gauthier', 'Affiliation': ""McGill Centre for Studies in Aging, Alzheimer's Disease Research Unit, and Douglas Mental Health University Institute, Montreal, QC, Canada.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Innovation Center for Neurological Disorders, Neurology Department, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kook', 'Affiliation': 'Salamandra LLC, Bethesda, MD, USA.'}, {'ForeName': 'John M D', 'Initials': 'JMD', 'LastName': 'Storey', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Harrington', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Claude M', 'Initials': 'CM', 'LastName': 'Wischik', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190772']
1107,31226213,Platelet reactivity and clinical outcomes in acute coronary syndrome patients treated with prasugrel and clopidogrel: a pre-specified exploratory analysis from the TROPICAL-ACS trial.,"AIMS
The value of platelet function testing (PFT) in predicting clinical outcomes and guiding P2Y12-inhibitor treatment is uncertain. In a pre-specified sub-study of the TROPICAL-ACS trial, we assessed ischaemic and bleeding risks according to high platelet reactivity (HPR) and low platelet reactivity (LPR) to ADP in patients receiving uniform prasugrel vs. PFT-guided clopidogrel or prasugrel.
METHODS AND RESULTS
Acute coronary syndrome patients with PFT done 14 days after hospital discharge were included with prior randomization to uniform prasugrel for 12 months (control group, no treatment modification) vs. early de-escalation from prasugrel to clopidogrel and PFT-guided maintenance treatment (HPR: switch-back to prasugrel, non-HPR: clopidogrel). The composite ischaemic endpoint included cardiovascular death, myocardial infarction, or stroke, while key safety outcome was Bleeding Academic Research Consortium (BARC) 2-5 bleeding, from PFT until 12 months. We identified 2527 patients with PFT results available: 1266 were randomized to the guided and 1261 to the control group. Before treatment adjustment, HPR was more prevalent in the guided group (40% vs. 15%), while LPR was more common in control patients (27% vs. 11%). Compared to control patients without HPR on prasugrel (n = 1073), similar outcomes were observed in guided patients kept on clopidogrel [n = 755, hazard ratio (HR): 1.06 (0.57-1.95), P = 0.86] and also in patients with HPR on clopidogrel switched to prasugrel [n = 511, HR: 0.96 (0.47-1.96), P = 0.91]. In contrast, HPR on prasugrel was associated with a higher risk for ischaemic events in control patients [n = 188, HR: 2.16 (1.01-4.65), P = 0.049]. Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups.
CONCLUSION
Based on this substudy of a randomized trial, selecting prasugrel or clopidogrel based on PFT resulted in similar ischaemic outcomes as uniform prasugrel therapy without HPR. Although infrequent, HPR on prasugrel was associated with increased risk of ischaemic events. Low platelet reactivity was a strong and independent predictor of bleeding both on prasugrel and clopidogrel.",2019,"Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups.
","['acute coronary syndrome patients treated with', '2527 patients with PFT results available: 1266 were randomized to the guided and 1261 to the control group', 'Acute coronary syndrome patients with PFT done 14\u2009days after hospital discharge were included with prior randomization to uniform', 'patients receiving uniform prasugrel vs. PFT-guided clopidogrel or prasugrel']","['clopidogrel', 'prasugrel and clopidogrel', 'prasugrel for 12\u2009months (control group, no treatment modification) vs. early de-escalation from prasugrel to clopidogrel and PFT-guided maintenance treatment (HPR: switch-back to prasugrel, non-HPR: clopidogrel']","['risk of ischaemic events', 'Platelet reactivity and clinical outcomes', 'ischaemic events', 'HPR', 'Low platelet reactivity', 'cardiovascular death, myocardial infarction, or stroke, while key safety outcome was Bleeding Academic Research Consortium (BARC) 2-5 bleeding']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4019284', 'cui_str': 'Uniforms'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299575', 'cui_str': 'Treatment modification'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392386', 'cui_str': 'Platelet count below reference range'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}]",2527.0,0.0460715,"Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups.
","[{'ForeName': 'Dániel', 'Initials': 'D', 'LastName': 'Aradi', 'Affiliation': 'Department of Active Cardiology, Heart Centre Balatonfüred and Heart and Vascular Centre, Semmelweis University Budapest, 2 Gyógy Tér, Balatonfüred, Hungary.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gross', 'Affiliation': 'Department of Cardiology, LMU München, Munich, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Centre Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Geisler', 'Affiliation': 'Department of Cardiology and Cardiovascular Disease, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Department of Cardiology, Heart and Vascular Centre, Semmelweis University Budapest, Budapest, Hungary.'}, {'ForeName': 'Róbert Gábor', 'Initials': 'RG', 'LastName': 'Kiss', 'Affiliation': 'Department of Cardiology, Military Hospital, Budapest, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Komócsi', 'Affiliation': 'Department of Interventional Cardiology, Heart Institute, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Csaba András', 'Initials': 'CA', 'LastName': 'Dézsi', 'Affiliation': 'Department of Cardiology, Petz Aladár County Hospital Győr, Győr, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Ruzsa', 'Affiliation': 'Department of Cardiology, Heart and Vascular Centre, Semmelweis University Budapest, Budapest, Hungary.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Ungi', 'Affiliation': 'Department of Cardiology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Konstantinos D', 'Initials': 'KD', 'LastName': 'Rizas', 'Affiliation': 'Department of Cardiology, LMU München, Munich, Germany.'}, {'ForeName': 'Andreas E', 'Initials': 'AE', 'LastName': 'May', 'Affiliation': 'Department of Cardiology, Innere Medizin I, Klinikum Memmingen, Memmingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mügge', 'Affiliation': 'Department of Cardiology, Katholisches Klinikum Bochum, St. Josef Hospital, Bochum, Germany.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Cardiology, Universitätsklinikum Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Lesca', 'Initials': 'L', 'LastName': 'Holdt', 'Affiliation': 'Institute of Laboratory Medicine, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Medical Department, Cardiology and Intensive Care Medicine, Sigmund Freud Private University, Medical School, Wien, Austria.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Centre Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Koltowski', 'Affiliation': '1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Zenon', 'Initials': 'Z', 'LastName': 'Huczek', 'Affiliation': '1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hadamitzky', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Deutsches Herzzentrum München, Munich, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': 'Department of Cardiology, LMU München, Munich, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'Department of Cardiology, LMU München, Munich, Germany.'}]",European heart journal,['10.1093/eurheartj/ehz202']
1108,31771038,The effectiveness of knee osteoarthritis treatment by arthroscopic microfracture technique in combination with autologous bone marrow stem cells transplantation.,"OBJECTIVE
We aimed to evaluate the efficacy of the treatment of knee osteoarthritis (OA) patients by using microfracture technique in combination with autologous bone marrow stem cell transplantation.
METHODS
A clinical study was conducted between November 2011 and January 2015 and involved 46 patients (aged from 46 to 69) with primary knee OA grade II and III (according to Kellgren-Lawrence classification) at the Orthopedic Trauma Department, Vietnam-Germany Friendship Hospital. Patients were randomly assigned to receive knee arthroscopy and then bone-marrow stem cells from their pelvic bones via injection.
RESULTS
The mean Visual Analogue Scale (VAS) score of present pain decreased from 5.68 before surgery to 1.7 24 months after surgery. The mean preoperative Knee Injury and Osteoarthritis Outcome Score (KOOS) was 36.34 (± 3.13), which increased to 74.62 (± 2.86) 24 months after surgery. On the MRI scans, the average Noyes score decreased from 12 (± 1.46) to 7 (± 1.50). Cartilage volume increased on average from 0.4512 (± 0.26) cm3 to 0.5463 (± 0.29) cm3 12-24 months after surgery.
CONCLUSION
Treatment of osteoarthritis by a combination of arthroscopic microfracture and transplantation of autologous bone-marrow stem cells was an invasive, safe and effective method which showed an improvement in the clinical symptoms (VAS score) and knee functions (KOOS points).",2020,"Cartilage volume increased on average from 0.4512 (± 0.26) cm3 to 0.5463 (± 0.29) cm3 12-24 months after surgery.
","['knee osteoarthritis (OA) patients', 'November 2011 and January 2015 and involved 46 patients (aged from 46 to 69) with primary knee OA grade II and III (according to Kellgren-Lawrence classification) at the Orthopedic Trauma Department, Vietnam-Germany Friendship Hospital']","['knee arthroscopy and then bone-marrow stem cells from their pelvic bones via injection', 'arthroscopic microfracture technique', 'arthroscopic microfracture and transplantation of autologous bone-marrow stem cells', 'microfracture technique in combination with autologous bone marrow stem cell transplantation', 'autologous bone marrow stem cells transplantation']","['average Noyes score', 'clinical symptoms (VAS score) and knee functions (KOOS points', 'mean preoperative Knee Injury and Osteoarthritis Outcome Score (KOOS', 'Cartilage volume', 'mean Visual Analogue Scale (VAS) score of present pain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C3887652', 'cui_str': 'Pelvic Bones'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1265651', 'cui_str': 'Micro Fractures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",46.0,0.0242667,"Cartilage volume increased on average from 0.4512 (± 0.26) cm3 to 0.5463 (± 0.29) cm3 12-24 months after surgery.
","[{'ForeName': 'Duong Dinh', 'Initials': 'DD', 'LastName': 'Toan', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Binh', 'Affiliation': '108 Military Central Hospital, Vietnam.'}, {'ForeName': 'Tran Trung', 'Initials': 'TT', 'LastName': 'Dung', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Luu Quang', 'Initials': 'LQ', 'LastName': 'Thuy', 'Affiliation': 'Viet Duc Hospital, Vietnam.'}, {'ForeName': 'Nguyen Dinh', 'Initials': 'ND', 'LastName': 'Hoa', 'Affiliation': 'Viet Duc Hospital, Vietnam.'}, {'ForeName': 'Nguyen Hoang', 'Initials': 'NH', 'LastName': 'Long', 'Affiliation': 'Viet Duc Hospital, Vietnam.'}, {'ForeName': 'Pham Son', 'Initials': 'PS', 'LastName': 'Tung', 'Affiliation': 'Saint Paul University Hospital, Hanoi, Vietnam.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191665']
1109,31038755,"Fecal Microbial Transplant Capsules Are Safe in Hepatic Encephalopathy: A Phase 1, Randomized, Placebo-Controlled Trial.","Hepatic encephalopathy (HE) can cause major morbidity despite standard of care (SOC; rifaximin/lactulose). Fecal microbial transplant (FMT) enemas postantibiotics are safe, but the effect of FMT without antibiotics using the capsular route requires investigation. The aim of this work was to determine the safety, tolerability, and impact on mucosal/stool microbiota and brain function in HE after capsular FMT in a randomized, single-blind, placebo-controlled clinical trial in Virginia. Patients with cirrhosis with recurrent HE with MELD (Model for End-Stage Liver Disease) <17 on SOC were randomized 1:1 into receiving 15 FMT capsules versus placebo from a single donor enriched in Lachnospiraceae and Ruminococcaceae. Endoscopies with duodenal and sigmoid biopsies, stool analysis, cognition, serum lipopolysaccharide-binding protein (LBP), and duodenal antimicrobial peptide (AMP) expression at baseline were used. Clinical follow-up with SOC maintenance was performed until 5 months. FMT-assigned patients underwent repeat endoscopies 4 weeks postenrollment. Twenty subjects on lactulose/rifaximin were randomized 1:1. MELD score was similar at baseline (9.6 vs. 10.2) and study end (10.2 vs. 10.5). Six patients in the placebo group required hospitalizations compared to 1 in FMT, which was deemed unrelated to FMT. Infection/HE episodes were similar between groups. Baseline microbial diversity was similar in all tissues between groups. Post-FMT, duodenal mucosal diversity (P = 0.01) increased with higher Ruminococcaceae and Bifidobacteriaceae and lower Streptococcaceae and Veillonellaceae. Reduction in Veillonellaceae were noted post-FMT in sigmoid (P = 0.04) and stool (P = 0.05). Duodenal E-cadherin (P = 0.03) and defensin alpha 5 (P = 0.03) increased whereas interleukin-6 (P = 0.02) and serum LBP (P = 0.009) reduced post-FMT. EncephalApp performance improved post-FMT only (P = 0.02). Conclusion: In this phase 1 study, oral FMT capsules are safe and well tolerated in patients with cirrhosis and recurrent HE. FMT was associated with improved duodenal mucosal diversity, dysbiosis, and AMP expression, reduced LBP, and improved EncephalApp performance. Further studies are needed to prove efficacy.",2019,Duodenal E-cadherin (P = 0.03) and defensin alpha 5,"['17 on SOC', 'Twenty subjects on', 'Patients with cirrhosis with recurrent HE with MELD (Model for End-Stage Liver Disease', 'patients with cirrhosis and recurrent HE', 'Hepatic Encephalopathy', 'Virginia']","['lactulose/rifaximin', 'placebo', 'Placebo', 'FMT capsules versus placebo', 'FMT']","['EncephalApp performance improved post-FMT', 'safe and well tolerated', 'Post-FMT, duodenal mucosal diversity', 'hospitalizations', 'Reduction in Veillonellaceae', 'serum LBP', 'higher Ruminococcaceae and Bifidobacteriaceae and lower Streptococcaceae and Veillonellaceae', 'HE episodes', 'Duodenal E-cadherin', 'Baseline microbial diversity', 'safety, tolerability, and impact on mucosal/stool microbiota and brain function', 'interleukin-6', 'MELD score', 'duodenal mucosal diversity, dysbiosis, and AMP expression, reduced LBP, and improved EncephalApp performance', 'Endoscopies with duodenal and sigmoid biopsies, stool analysis, cognition, serum lipopolysaccharide-binding protein (LBP), and duodenal antimicrobial peptide (AMP) expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3826979', 'cui_str': 'MELD-Model for end-stage liver disease'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}]","[{'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042447', 'cui_str': 'Acidaminococcaceae'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C1003847', 'cui_str': 'Family Bifidobacteriaceae'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038394', 'cui_str': 'Streptococcaceae'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042172', 'cui_str': 'Cadherin-1'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0202010', 'cui_str': 'Feces examination - general (procedure)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0065054', 'cui_str': 'LPS-binding protein'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]",20.0,0.423193,Duodenal E-cadherin (P = 0.03) and defensin alpha 5,"[{'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Nita H', 'Initials': 'NH', 'LastName': 'Salzman', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Chathur', 'Initials': 'C', 'LastName': 'Acharya', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Sterling', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'White', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Gavis', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fagan', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayward', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Holtz', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Matherly', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Majdi', 'Initials': 'M', 'LastName': 'Osman', 'Affiliation': 'OpenBiome, Somerville, MA.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'OpenBiome, Somerville, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Puri', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sikaroodi', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, VA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Gillevet', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, VA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30690']
1110,31207908,Low-Fat Diet Designed for Weight Loss But Not Weight Maintenance Improves Nitric Oxide-Dependent Arteriolar Vasodilation in Obese Adults.,"Obesity is associated with microvascular dysfunction. While low-fat diet improves cardiovascular risk, its contributions on microvascular function, independent of weight loss, is unknown. We tested the hypothesis that nitric oxide (NO)-dependent vasodilation in microvessels is improved by low-fat diets designed for weight loss (LFWL) compared to low-fat weight maintenance (LFWM) diet. Obese adults were randomly assigned to either a LFWL diet ( n = 11) or LFWM diet ( n = 10) for six weeks. Microvessels were obtained from gluteal subcutaneous fat biopsies before and after the intervention for vascular reactivity measurements to acetylcholine (Ach) and flow, with and without L-NAME or indomethacin. Vascular and serum NO and C-reactive protein (CRP) were also measured. LFWL diet increased flow-induced (FID) and ACh-induced dilation (AChID); an effect that was inhibited by L-NAME. Conversely, LFWM diet did not affect FID or AChID. Indomethacin improved FID and AChID in the baseline and this effect was minimized in response to both diets. Serum NO or CRP did not change in response to either diet. In conclusion, LFWL diet improves microvascular reactivity compared to LFWM diet and increased vascular NO contribution to the improved microvascular dilation. These data suggest that weight reduction on low fat diet is critical for microvascular health.",2019,LFWL diet increased flow-induced (FID) and ACh-induced dilation (AChID); an effect that was inhibited by L-NAME.,"['Obese adults', 'Obese Adults']","['Indomethacin', 'indomethacin', 'LFWM diet', 'LFWL diet']","['cardiovascular risk', 'FID or AChID', 'Vascular and serum', 'Serum', 'FID and AChID', 'microvascular reactivity', 'Weight Loss', 'microvascular dilation', 'LFWL diet increased flow-induced (FID) and ACh-induced dilation (AChID', 'NO and C-reactive protein (CRP']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.0224217,LFWL diet increased flow-induced (FID) and ACh-induced dilation (AChID); an effect that was inhibited by L-NAME.,"[{'ForeName': 'Abeer M', 'Initials': 'AM', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA. amahmo4@uic.edu.'}, {'ForeName': 'Chueh-Lung', 'Initials': 'CL', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA. clhwang@uic.edu.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Szczurek', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA. mszczurek@uic.edu.'}, {'ForeName': 'Jing-Tan', 'Initials': 'JT', 'LastName': 'Bian', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA. jtbian@uic.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ranieri', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA. craneri@uic.edu.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Gutterman', 'Affiliation': 'Cardiovascular Center, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI 53226, USA. dgutt@mcw.edu.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA. shanep@uic.edu.'}]",Nutrients,['10.3390/nu11061339']
1111,31204031,A randomized clinical trial comparing the McKenzie method and motor control exercises in people with chronic low back pain and a directional preference: 1-year follow-up.,"OBJECTIVE
The primary objective of this study was to compare the long-term (1-year follow-up) effects of the McKenzie method and motor control exercises on trunk muscle thickness in people with chronic low back pain (LBP) and a directional preference.
DESIGN
Randomized controlled trial.
SETTING
A secondary public health facility in Sydney, Australia.
PARTICIPANTS
Seventy adults with greater than 3-month history of LBP and a directional preference.
INTERVENTIONS
Participants were randomized to receive 12 treatments of either the McKenzie method or motor control exercises over 8-weeks.
OUTCOME MEASURES
Muscle thickness of the transversus abdominis, obliquus internus, and obliquus externus measured from ultrasound images. Secondary outcomes included function, perceived recovery, and pain. Outcomes were collected at baseline, post intervention at 8-weeks, and at 1-year follow-up by blinded assessors. The current paper focuses on the 1-year follow-up.
RESULTS
Fifty-eight participants completed data collection for the primary outcome at 1-year. There were no significant between group differences for changes in trunk muscle thickness for any of the three investigated muscles: transversus abdominis [3%, 95% confidence interval (CI): -5%, 11%], obliquus internus [-4%, 95% CI: -9%, 2%] and obliquus externus [3%, 95% CI: -4%, 11%]. Similarly, there were no significant differences between groups for the secondary outcomes of function, perceived recovery and pain.
CONCLUSION
Trunk muscle thickness, function, perceive recovery and pain are similar between patients receiving McKenzie method or motor control exercises at a 1-year follow-up in a population of people with chronic LBP and a directional preference. Clinical Trials Registration number CTRN12611000971932.",2019,"There were no significant between group differences for changes in trunk muscle thickness for any of the three investigated muscles: transversus abdominis [3%, 95% confidence interval (CI): -5%, 11%], obliquus internus [-4%, 95% CI: -9%, 2%] and obliquus externus [3%, 95% CI: -4%, 11%].","['people with chronic low back pain (LBP) and a directional preference', 'Seventy adults with greater than 3-month history of LBP and a directional preference', 'people with chronic low back pain and a directional preference', 'A secondary public health facility in Sydney, Australia']","['McKenzie method or motor control exercises', 'McKenzie method or motor control exercises over 8-weeks', 'McKenzie method and motor control exercises']","['function, perceived recovery and pain', 'function, perceived recovery, and pain', 'Muscle thickness of the transversus abdominis, obliquus internus, and obliquus externus measured from ultrasound images', 'trunk muscle thickness']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0449770', 'cui_str': 'Measured from (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}]",70.0,0.261614,"There were no significant between group differences for changes in trunk muscle thickness for any of the three investigated muscles: transversus abdominis [3%, 95% confidence interval (CI): -5%, 11%], obliquus internus [-4%, 95% CI: -9%, 2%] and obliquus externus [3%, 95% CI: -4%, 11%].","[{'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Halliday', 'Affiliation': 'Concord Repatriation General Hospital, Hospital Rd, Concord, Australia; The University of Sydney, Faculty of Health Sciences, Discipline of Physiotherapy, 75 East St, Lidcombe, Australia. Electronic address: Mark.Halliday@health.nsw.gov.au.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Pappas', 'Affiliation': 'The University of Sydney, Faculty of Health Sciences, Discipline of Physiotherapy, 75 East St, Lidcombe, Australia.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': 'Macquarie University, Faculty of Medicine and Health Science, Herring Rd, North Ryde, Australia.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Clare', 'Affiliation': 'Helen Clare Physiotherapy, 263 Pacific Highway, Crows Nest, Australia.'}, {'ForeName': 'Rafael Z', 'Initials': 'RZ', 'LastName': 'Pinto', 'Affiliation': 'Sao Paulo State University, Department of Physical Therapy, Faculty of Science and Technology, Sao Paulo, Brazil.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Robertson', 'Affiliation': 'Concord Repatriation General Hospital, Hospital Rd, Concord, Australia.'}, {'ForeName': 'Paulo H', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'The University of Sydney, Faculty of Health Sciences, Discipline of Physiotherapy, 75 East St, Lidcombe, Australia.'}]",Physiotherapy,['10.1016/j.physio.2018.12.004']
1112,31195354,High prevalence of severe hypovitaminosis D in patients with advanced gastric cancer treated with first-line chemotherapy with or without anti-EGFR-directed monoclonal antibody (EXPAND trial) showing no prognostic impact.,"PURPOSE
The goal of our analysis was to study pretherapeutic circulating 25-OHD plasma levels in patients with previously untreated advanced gastric cancer treated in the randomised controlled phase III Erbitux (cetuximab) in combination with Xeloda (capecitabine) and cisplatin in advanced esophago-gastric cancer (EXPAND) trial (NCT00678535) and to explore whether low 25-OHD plasma levels are associated with worse prognosis and may compromise the clinical efficacy of cetuximab.
METHODS
Six hundred thirty patients with available pretherapeutic 25-OHD plasma levels and treated with chemotherapy based on capecitabine and cisplatin, or chemotherapy and cetuximab, were included. The Cox proportional hazard regression model was used to analyse the association between low 25-OHD and survival in both treatment arms.
RESULTS
Majority of study patients were found to have severe vitamin D deficiency. No prognostic impact of 25-OHD plasma levels could be found in our patient cohort, and there was no indication of an interference of 25-OHD plasma levels and the efficacy of treatment with the anti-epidermal growth factor receptor monoclonal antibody cetuximab.
CONCLUSIONS
Although majority of patients with advanced gastric cancer show hypovitaminosis D deficiency, there is no proof for a negative impact on survival or reduced treatment response. A prospective study is needed to investigate the potential benefit of vitamin D supplementation in this patient cohort during first-line chemotherapy.",2019,"No prognostic impact of 25-OHD plasma levels could be found in our patient cohort, and there was no indication of an interference of 25-OHD plasma levels and the efficacy of treatment with the anti-epidermal growth factor receptor monoclonal antibody cetuximab.
","['patients with advanced gastric cancer', 'patients with advanced gastric cancer treated with', 'patients with previously untreated advanced gastric cancer', 'Six hundred thirty patients with available pretherapeutic 25-OHD plasma levels and treated with chemotherapy based on', 'patient cohort during first-line chemotherapy']","['capecitabine and cisplatin, or chemotherapy and cetuximab', 'Erbitux (cetuximab) in combination with Xeloda (capecitabine) and cisplatin', 'vitamin D supplementation', 'first-line chemotherapy with or without anti-EGFR-directed monoclonal antibody']","['25-OHD plasma levels', 'severe vitamin D deficiency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1173436', 'cui_str': 'Erbitux'}, {'cui': 'C0724419', 'cui_str': 'Xeloda'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]",630.0,0.0376936,"No prognostic impact of 25-OHD plasma levels could be found in our patient cohort, and there was no indication of an interference of 25-OHD plasma levels and the efficacy of treatment with the anti-epidermal growth factor receptor monoclonal antibody cetuximab.
","[{'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Obermannova', 'Affiliation': 'Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Faculty of Medicine, Masaryk University, Brno, Czech Republic; Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Valik', 'Affiliation': 'Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Laboratory Medicine, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hasenclever', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology, Medical Faculty of University Leipzig, Germany.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Zdrazilova-Dubska', 'Affiliation': 'Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Laboratory Medicine, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hacker', 'Affiliation': '1st Medical Department (Hematology, Cell Therapy, Medical Oncology and Hemostaseology), University Cancer Center Leipzig (UCCL), University Leipzig Medical Center, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Demlova', 'Affiliation': 'Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Selingerova', 'Affiliation': 'Regional Center of Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic; Department of Laboratory Medicine, Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': '1st Medical Department (Hematology, Cell Therapy, Medical Oncology and Hemostaseology), University Cancer Center Leipzig (UCCL), University Leipzig Medical Center, Germany. Electronic address: florian.lordick@medizin.uni-leipzig.de.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.05.011']
1113,31789899,An ultrasound assessment of gastric emptying following tea with milk in pregnancy: A randomised controlled trial.,"BACKGROUND
Peri-operative fasting guidelines allow clear fluids including tea without milk to be consumed up to 2 h before surgery. Recent evidence has shown that a modest amount of milk consumed with clear fluids does not significantly slow gastric emptying.
OBJECTIVES
The aim of this study was to compare the gastric emptying of tea with milk versus water using ultrasonography in fasted pregnant patients.
DESIGN
A randomised controlled trial quantifying gastric emptying in two groups using ultrasonography by an operator blinded to the group allocation.
SETTING
Department of Anaesthesia and Peri-operative Medicine, Coombe Women and Infants University Hospital, Dublin. The study was conducted between October 2018 and June 2019.
PARTICIPANTS
Total 50 nonlabouring pregnant women, more than 36 weeks gestation.
INTERVENTIONS
After a standard overnight fast, women were randomised to either 250 ml of water or 250 ml of tea with milk. All patients underwent a gastric ultrasound assessment at regular intervals for 2 h after consumption of their drink.
MAIN OUTCOME MEASURE
The primary outcome was the difference in gastric antrum cross-sectional area (CSA) at 2 h.
RESULTS
A total of 50 women were recruited to the study. There was no significant difference in the median [IQR] gastric antrum CSA in either group at 2 h: 3.2 cm [2.3 to 3.7] vs. 3.1 cm [2.6 to 3.9]; P = 0.720. The gastric antrum CSA had returned to its baseline measurement in both groups by 90 min.
CONCLUSION
The change of gastric antrum CSA after 250 ml of tea with milk is similar to a corresponding volume of water in fasted pregnant patients. This study could help inform future peri-operative fasting guidelines regarding the use of a modest volume of milk with clear fluids.
TRIAL REGISTRY NUMBER
NCT03694509 ClinicalTrials.gov.",2020,There was no significant difference in the median [IQR] gastric antrum CSA in either group at 2 h: 3.2 cm [2.3 to 3.7] vs. 3.1 cm [2.6 to 3.9]; P = 0.720.,"['Department of Anaesthesia and Peri-operative Medicine, Coombe Women and Infants University Hospital, Dublin', 'gastric emptying following tea with milk in pregnancy', 'A total of 50 women were recruited to the study', 'fasted pregnant patients', 'Total 50 nonlabouring pregnant women, more than 36 weeks gestation', 'October 2018 and June 2019']","['tea with milk versus water using ultrasonography', '250\u200aml of water or 250\u200aml of tea with milk']","['gastric antrum cross-sectional area (CSA', 'gastric antrum CSA', 'median [IQR] gastric antrum CSA']","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0454777', 'cui_str': 'Dublin (geographic location)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0452438', 'cui_str': 'Tea with milk (substance)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0452438', 'cui_str': 'Tea with milk (substance)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0034193', 'cui_str': 'Gastric Antrum'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",50.0,0.286725,There was no significant difference in the median [IQR] gastric antrum CSA in either group at 2 h: 3.2 cm [2.3 to 3.7] vs. 3.1 cm [2.6 to 3.9]; P = 0.720.,"[{'ForeName': 'Ruairi', 'Initials': 'R', 'LastName': 'Irwin', 'Affiliation': 'From the Department of Anaesthesia and Perioperative Medicine (RI, TT) and Department of Obstetrics and Gynaecology, Coombe Women and Infants University Hospital, Dublin, Ireland (IG, BK, NG, SM).'}, {'ForeName': 'Icchya', 'Initials': 'I', 'LastName': 'Gyawali', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Kennedy', 'Affiliation': ''}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Garry', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Milne', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001129']
1114,31779179,"Effects of Vitamin D and Calcium Fortified Yogurts on Gait, Cognitive Performances, and Serum 25-Hydroxyvitamin D Concentrations in Older Community-Dwelling Females: Results from the GAit, MEmory, Dietary and Vitamin D (GAME-D2) Randomized Controlled Trial.","BACKGROUND
Vitamin D 3 fortified food may improve serum vitamin D level, suggesting that the prevention of adverse consequences of hypovitaminosis D is possible with food fortification. The aim of this randomized controlled trial (RCT) was to examine the effects of vitamin D and calcium fortified yogurt on spatiotemporal gait parameters, cognitive performance, handgrip strength, and serum 25OHD levels in healthy older females.
METHODS
Forty older community-dwelling females were recruited in a single-blind, randomized, controlled, superiority clinical trial in two parallel groups (20 participants in the intervention group and 20 in the control group) with intent-to-treat. The intervention group took fortified yogurts daily (i.e., 400 UI of vitamin D 3 and 800 mg calcium) for 3 months. The non-fortified yogurts contained similar proteins, carbohydrates and lipids, as well as a lower dose of calcium (300 mg) and no vitamin D 3 supplementation. Spatiotemporal gait parameters (mean value and coefficient of variation) were assessed using a computerized walkway. Handgrip strength was measured with hydraulic dynamometers. Cognitive performances, including global cognitive functioning assessed with the Mini Mental Status Examination (MMSE) were recorded. All the outcomes were assessed at baseline and at the end of follow-up. The primary outcome was the coefficient of variation of stride time.
RESULTS
The intervention group maintained its global cognitive performance and serum 25OHD concentrations, whereas these outcomes decreased (i.e., worst performance) in the control group. The changes in the MMSE score ( p = 0.022) and serum 25OHD concentrations were different ( p ≤ 0.001) with better values reported in the intervention group compared to the control group. There was no significant change in gait parameters ( p ≥ 0.518) and handgrip strength ( p ≥ 0.600).
CONCLUSIONS
Fortified yogurts with vitamin D (i.e., 200 IU) and calcium (i.e., 400 mg) twice a day maintained global cognitive performance and vitamin D status in older females, but not gait performances, signifying that they mainly prevent hypovitaminosis D-related extra-skeletal disorders.",2019,The changes in the MMSE score ( p = 0.022) and serum 25OHD concentrations were different ( p ≤ 0.001) with better values reported in the intervention group compared to the control group.,"['healthy older females', 'Forty older community-dwelling females', 'Older Community-Dwelling Females', 'older females']","['GAit, MEmory, Dietary and Vitamin D (GAME-D2', 'Vitamin D and Calcium Fortified Yogurts', 'vitamin D and calcium fortified yogurt', 'fortified yogurts daily (i.e., 400 UI of vitamin D 3 and 800 mg calcium']","['global cognitive performance and serum 25OHD concentrations', 'serum 25OHD concentrations', 'serum vitamin D level', 'Spatiotemporal gait parameters (mean value and coefficient of variation', 'coefficient of variation of stride time', 'handgrip strength', 'gait parameters', 'MMSE score', 'spatiotemporal gait parameters, cognitive performance, handgrip strength, and serum 25OHD levels', 'Handgrip strength', 'Gait, Cognitive Performances, and Serum 25-Hydroxyvitamin D Concentrations', 'Cognitive performances, including global cognitive functioning assessed with the Mini Mental Status Examination (MMSE']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",400.0,0.297599,The changes in the MMSE score ( p = 0.022) and serum 25OHD concentrations were different ( p ≤ 0.001) with better values reported in the intervention group compared to the control group.,"[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Beauchet', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis-Jewish General Hospital and Lady Davis Institute for Medical Research, McGill University, Montreal, QC H3T 1E2, Canada.'}, {'ForeName': 'Cyrille P', 'Initials': 'CP', 'LastName': 'Launay', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis-Jewish General Hospital and Lady Davis Institute for Medical Research, McGill University, Montreal, QC H3T 1E2, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Galery', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis-Jewish General Hospital and Lady Davis Institute for Medical Research, McGill University, Montreal, QC H3T 1E2, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vilcocq', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis-Jewish General Hospital and Lady Davis Institute for Medical Research, McGill University, Montreal, QC H3T 1E2, Canada.'}, {'ForeName': 'Flore', 'Initials': 'F', 'LastName': 'Dontot-Payen', 'Affiliation': 'Nutrition & Regulatory Affairs, Yoplait SAS, 92641 Boulogne-Billancourt, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Rousseau', 'Affiliation': 'Nutrition & Regulatory Affairs, Yoplait SAS, 92641 Boulogne-Billancourt, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Benoit', 'Affiliation': 'The Bell Institute of Health and Nutrition, General Mills Inc., Minneapolis, MN 55427, USA.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Allali', 'Affiliation': 'Department of Neurology, Geneva University Hospital and University of Geneva, 1205 Genève, Switzerland.'}]",Nutrients,['10.3390/nu11122880']
1115,31764271,Implementation Science Using Proctor's Framework and an Adaptation of the Multiphase Optimization Strategy: Optimizing a Financial Incentive Intervention for HIV Treatment Adherence in Tanzania.,"BACKGROUND
Ambitious targets have been set to end the HIV epidemic by 2030. Such targets assume that tools to end HIV exist and are successfully being deployed across populations, albeit unequally. Implementation science approaches are needed to understand the drivers of disparities and how to bring effective interventions to those most in need. We describe a hybrid implementation science approach, adapting a strategy to facilitate retention and viral suppression (VS) among people living with HIV/AIDS in Tanzania.
METHODS/DESIGN
We used Proctor framework and the multiphase optimization strategy to optimize a cash transfer to improve antiretroviral therapy adherence and VS among people living with HIV/AIDS in Tanzania. This involved 3 trials. The first trial tested the efficacy of cash and food assistance compared with the standard of care in improving antiretroviral therapy adherence among treatment initiators. Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food. The second trial is dose-finding: identifying the optimal amount of cash for a 20% improvement in VS at 6 months. Before this, components were simplified to maximize reach, align with local policies, and reduce staff time. We assessed implementation science constructs to understand barriers to uptake and sustainability. Trial 3 is a cluster randomized controlled trial, testing the effectiveness of the optimized intervention in multiple settings.
DISCUSSION/IMPLICATIONS
Our process illustrates the utility of applying multiple implementation science frameworks to arrive at an optimal implementation strategy to bridge the know-do gap with data to show efficacy and maximum potential for scalability and sustainability.",2019,"Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food.","['people living with HIV/AIDS in Tanzania', 'HIV Treatment Adherence in Tanzania']","['Financial Incentive Intervention', 'cash and food assistance']",[],"[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C3494395', 'cui_str': 'Food Assistance'}]",[],,0.109746,"Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Packel', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, School of Public Health, Berkeley, CA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Fahey', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, School of Public Health, Berkeley, CA.'}, {'ForeName': 'Prosper', 'Initials': 'P', 'LastName': 'Njau', 'Affiliation': 'Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sandra I', 'Initials': 'SI', 'LastName': 'McCoy', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, School of Public Health, Berkeley, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002196']
1116,31200852,"Re: Arnaud Méjean, Alain Ravaud, Simon Thezenas, et al. Sunitinib Alone or After Nephrectomy in Metastatic Renal-cell Carcinoma. N Engl J Med 2018;379:417-27: CARMENA Trial: Is This the End of Cytoreductive Nephrectomy in Patients with Clear-cell Renal Cell Carcinoma?",,2019,,"['Metastatic Renal-cell Carcinoma', 'Patients with Clear-cell Renal Cell Carcinoma']","['Sunitinib Alone or After Nephrectomy', 'Cytoreductive Nephrectomy']",[],"[{'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}]",[],,0.0203389,,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy. Electronic address: fmassari79@gmail.com.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Di Nunno', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Santoni', 'Affiliation': 'Oncology Unit, Macerata Hospital, Macerata, Italy.'}]",European urology oncology,['10.1016/j.euo.2018.08.002']
1117,31774526,Association of Obesity With Septic Complications After Major Abdominal Surgery: A Secondary Analysis of the RELIEF Randomized Clinical Trial.,"Importance
Body mass index (BMI) has been the most common obesity measure to assess perioperative risk; however, cardiometabolic risk is associated with the burden of visceral fat. Definitive evidence on the association of visceral fat measures, such as waist circumference and waist-to-hip ratio (WHR), with postoperative complications is lacking.
Objective
To compare the value of waist circumference with the value WHR and BMI in predicting adverse outcomes, including major septic complications and persistent disability, following major abdominal surgery.
Design, Setting, and Participants
This planned secondary analysis of the Restrictive vs Liberal Fluid Therapy for Major Abdominal Surgery (RELIEF) randomized clinical trial took place at 47 centers in 7 countries between October 2013 and September 2016, with 90-day follow-up. A total of 2954 adult RELIEF participants were coenrolled in this secondary analysis. Data analysis took place from December 2018 to September 2019.
Exposures
Waist circumference, WHR, and BMI measurements.
Main Outcomes and Measures
The primary outcomes were 30-day major septic complications and 90-day persistent disability or death.
Results
Of 2954 eligible participants, 2755 were included (mean [SD] age, 65.9 [12.9] years; 1426 [51.8%] men) in the final analysis. A total of 564 participants (20.6%) experienced at least 1 major septic complication within 30 days after surgery (sepsis, 265 [9.7%]; surgical site infection, 409 [14.9%]; anastomotic leak, 78 [2.8%]; pneumonia, 104 [3.8%]). Waist circumference had a statistically significantly larger odds ratio (OR) and discrimination indices as well as a smaller prediction error than WHR or BMI for 30-day major septic complications or death (waist circumference: OR, 1.44; 95% CI, 1.28-1.62; P < .001; area under the receiver operating characteristic curve, 0.641; net reclassification index, 0.266; integrated discrimination improvement [score × 104], 152.98; Brier score, 0.162; WHR: OR, 1.15; 95% CI, 1.03-1.28; P = .01; area under the receiver operating characteristic curve, 0.621; net classification index, 0.199; integrated discrimination improvement [score × 104], 28.47; Brier score, 0.164; BMI: OR, 1.33; 95% CI, 1.17-1.50; P < .001; area under the receiver operating characteristic curve, 0.629; net reclassification index, 0.205; integrated discrimination improvement [score × 104], 85.61; Brier score, 0.163) but not for any other outcomes.
Conclusions and Relevance
In this secondary analysis of the RELIEF randomized clinical trial, waist circumference was observed to be superior to other adiposity indices in predicting 30-day major septic complications alone or in conjunction with death following elective major abdominal surgery. Findings suggest that waist circumference is a useful adiposity measure that should be incorporated in preoperative risk assessment for such complications.
Trial Registration
ClinicalTrials.gov identifier: NCT01424150.",2019,"Waist circumference had a statistically significantly larger odds ratio (OR) and discrimination indices as well as a smaller prediction error than WHR or BMI for 30-day major septic complications or death (waist circumference: OR, 1.44; 95% CI, 1.28-1.62; P < .001; area under the receiver operating characteristic curve, 0.641; net reclassification index, 0.266; integrated discrimination improvement [score × 104], 152.98; Brier score, 0.162; WHR: OR, 1.15; 95% CI, 1.03-1.28; P = .01; area under the receiver operating characteristic curve, 0.621; net classification index, 0.199; integrated discrimination improvement [score × 104], 28.47; Brier score, 0.164; BMI: OR, 1.33; 95% CI, 1.17-1.50; P < .001; area under the receiver operating characteristic curve, 0.629; net reclassification index, 0.205; integrated discrimination improvement [score × 104], 85.61; Brier score, 0.163) but not for any other outcomes.
","['2954 eligible participants, 2755 were included (mean [SD] age, 65.9 [12.9] years; 1426 [51.8', 'Major Abdominal Surgery (RELIEF) randomized clinical trial took place at 47 centers in 7 countries between October 2013 and September 2016, with 90-day follow-up', '2954 adult RELIEF participants', 'After Major Abdominal Surgery']",['Restrictive vs Liberal Fluid Therapy'],"['anastomotic leak', 'Waist circumference', 'larger odds ratio (OR) and discrimination indices', 'Obesity With Septic Complications', 'septic complication', 'surgical site infection', 'Exposures\n\n\nWaist circumference, WHR, and BMI measurements', '30-day major septic complications and 90-day persistent disability or death', 'waist circumference and waist-to-hip ratio (WHR']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]","[{'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}]",2954.0,0.302775,"Waist circumference had a statistically significantly larger odds ratio (OR) and discrimination indices as well as a smaller prediction error than WHR or BMI for 30-day major septic complications or death (waist circumference: OR, 1.44; 95% CI, 1.28-1.62; P < .001; area under the receiver operating characteristic curve, 0.641; net reclassification index, 0.266; integrated discrimination improvement [score × 104], 152.98; Brier score, 0.162; WHR: OR, 1.15; 95% CI, 1.03-1.28; P = .01; area under the receiver operating characteristic curve, 0.621; net classification index, 0.199; integrated discrimination improvement [score × 104], 28.47; Brier score, 0.164; BMI: OR, 1.33; 95% CI, 1.17-1.50; P < .001; area under the receiver operating characteristic curve, 0.629; net reclassification index, 0.205; integrated discrimination improvement [score × 104], 85.61; Brier score, 0.163) but not for any other outcomes.
","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Gurunathan', 'Affiliation': 'Department of Anaesthesia and Perfusion Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ivan L', 'Initials': 'IL', 'LastName': 'Rapchuk', 'Affiliation': 'Department of Anaesthesia and Perfusion Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Marilla', 'Initials': 'M', 'LastName': 'Dickfos', 'Affiliation': 'Department of Anaesthesia and Perfusion Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Larsen', 'Affiliation': 'Department of Anaesthesia and Perfusion Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Myles', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Victoria, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.16345']
1118,31580003,Transabdominal versus transvaginal specimen extraction in mini-laparoscopic surgery.,"AIM
The objective of this study was to present our experiences of tissue extraction via the transvaginal (TV) route after a mini-laparoscopic gynecological surgery and compare them with our transabdominal (TA) specimen extraction experiences.
METHODS
This prospective randomized controlled study was conducted in a tertiary care center between July 2014 and February 2016. Fifty-eight women who were undergoing mini-laparoscopy for adnexal mass removal were randomized into two groups according to the surgical specimen removal by the TV route (n = 28) or the TA route (n = 30). The main outcome measures were the postoperative incisional pain, cosmetic outcomes and overall satisfaction rate. The secondary outcome measures were additional blood loss, additional operation duration and the need for morcellation.
RESULTS
The TV group had significantly lower visual analog scale scores than the TA group at 6 and 24 h postoperatively. The morcellation needs were lower in the TV group than in the TA group. Three months after the surgery, the participants scored a higher rate of overall satisfaction in the cosmetic outcomes in the TV group than in the TA group.
CONCLUSION
Tissue extraction through a posterior colpotomy after mini-laparoscopic surgery may be a feasible technique for improving cosmetic results, decreasing postoperative pain and decreasing the need for morcellation when compared to TA specimen retrieval.",2019,"Three months after the surgery, the participants scored a higher rate of overall satisfaction in the cosmetic outcomes in the TV group than in the TA group.
","['tertiary care center between July 2014 and February 2016', 'mini-laparoscopic surgery', 'Fifty-eight women who were undergoing mini-laparoscopy for adnexal mass removal']","['tissue extraction via the transvaginal (TV) route after a mini-laparoscopic gynecological surgery', 'surgical specimen removal by the TV route', 'TA route', 'Transabdominal versus transvaginal specimen extraction']","['postoperative pain', 'additional blood loss, additional operation duration and the need for morcellation', 'morcellation needs', 'postoperative incisional pain, cosmetic outcomes and overall satisfaction rate', 'visual analog scale scores', 'overall satisfaction']","[{'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0149614', 'cui_str': 'Adnexal mass'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",58.0,0.079243,"Three months after the surgery, the participants scored a higher rate of overall satisfaction in the cosmetic outcomes in the TV group than in the TA group.
","[{'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Soyman', 'Affiliation': 'Department of Obstetrics and Gynecology, İstanbul Education and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Sefa', 'Initials': 'S', 'LastName': 'Kelekci', 'Affiliation': 'Department of Obstetrics and Gynecology, İzmir Katip Celebi University, School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Aydogmus', 'Affiliation': 'Department of Obstetrics and Gynecology, İzmir Katip Celebi University, School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Demirel', 'Affiliation': 'Department of Obstetrics and Gynecology, İzmir Katip Celebi University, School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Ekmekci', 'Affiliation': 'Department of Obstetrics and Gynecology, İzmir Katip Celebi University, School of Medicine, Izmir, Turkey.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14134']
1119,31784929,"Evaluation of bradykinin, VEGF, and EGF biomarkers in gingival crevicular fluid and comparison of PhotoBioModulation with conventional techniques in periodontitis: a split-mouth randomized clinical trial.","Periodontal disease is a chronic progressive inflammatory process leading to damage of tooth-supporting tissues. This comparative study assessed the effect of PhotoBioModulation (PBM) versus conventional therapy, and investigated biomarkers involved in the healing process. The test group comprised twenty systemically-healthy non-smoking subjects with chronic periodontitis with the presence of two matched contro-lateral premolar sites (probing depth > 5 mm); twenty subjects without chronic periodontitis (CP) served as control group. Patients were treated at baseline, either with scaling and root planing (SRP group) or with a procedure entailing SRP supported by PBM (PBM group). The laser used was a diode laser operating at 645 nm wavelength, 10 J/cm2, and 0.5 W/cm2 with a 600 μm fiber optic. Crevicular fluid levels of bradykinin (BK), vascular endothelial growth factor (VEGF), and epidermal growth factor z (EGF) were determined at both sites. Crevicular fluid specimens from both groups were analyzed with the ELISA TEST. Clinical differences in analyzed outcomes were observed in favor of PBM treatment. Taking average values as 100%, the reduction in BK concentration was 47.68% with SRP and 68.43% with PBM on day 3; the VEGF concentration decreased by 35.73% with SRP and 48.59% with PBM on day 7; the EGF concentration increased by 55.58% with SRP and by 58.11% with PBM on day 21.Clinical parameters improved significantly in both groups (pooled mean values of probing depth decreased from 5.6 to 4.5 mm; gingival index from 1.92 to 1.1; and bleeding on probing from 49.67 to 23.23) but did not vary significantly between the PBM and the SRP group. The results confirmed that PBM have beneficial effects in the early phases of the healing process playing a role in modulation of BK, EGF, and VEGF in gingival crevicular fluid levels; both groups had significant clinical improvement over control but there was no significant difference between them, only a trend for PBM group. The overall results of the study suggest a potential benefit of PBM in conjunction with SRP in treating chronic periodontitis.",2020,Clinical differences in analyzed outcomes were observed in favor of PBM treatment.,"['periodontitis', 'twenty systemically-healthy non-smoking subjects with chronic periodontitis with the presence of two matched contro-lateral premolar sites (probing depth > 5 mm); twenty subjects without chronic periodontitis (CP) served as control group']","['scaling and root planing (SRP group) or with a procedure entailing SRP supported by PBM (PBM group', 'bradykinin, VEGF, and EGF biomarkers', 'PBM', 'PhotoBioModulation (PBM']","['VEGF concentration', 'EGF concentration', 'gingival index', 'Crevicular fluid levels of bradykinin (BK), vascular endothelial growth factor (VEGF), and epidermal growth factor z (EGF', 'probing depth', 'BK concentration']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0006100', 'cui_str': 'Arg-Pro-Pro-Gly-Phe-Ser-Pro-Phe-Arg'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0006100', 'cui_str': 'Arg-Pro-Pro-Gly-Phe-Ser-Pro-Phe-Arg'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",20.0,0.0273185,Clinical differences in analyzed outcomes were observed in favor of PBM treatment.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Angiero', 'Affiliation': 'Department of Medical Sciences and Diagnostic Integrated, University of Genoa, Genova, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ugolini', 'Affiliation': 'Department of Medical Sciences and Diagnostic Integrated, University of Genoa, Genova, Italy. Alessandro.ugolini@unige.it.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cattoni', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bova', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Blasi', 'Affiliation': 'Department of Medical Sciences and Diagnostic Integrated, University of Genoa, Genova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Gallo', 'Affiliation': 'Section of Biostatistics, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Gianguido', 'Initials': 'G', 'LastName': 'Cossellu', 'Affiliation': ""Department of Biomedical, Surgical and Dental Sciences, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Gherlone', 'Affiliation': 'Dental School, Vita-Salute San Raffaele University, Milan, Italy.'}]",Lasers in medical science,['10.1007/s10103-019-02919-w']
1120,30844048,Febuxostat for Cerebral and CaRdiorenovascular Events PrEvEntion StuDy.,"AIMS
To compare the occurrence of cerebral, cardiovascular, and renal events in patients with hyperuricaemia treated with febuxostat and those treated with conventional therapy with lifestyle modification.
METHODS AND RESULTS
This multicentre, prospective, randomized open-label, blinded endpoint study was done in 141 hospitals in Japan. A total of 1070 patients were included in the intention-to-treat population. Elderly patients with hyperuricaemia (serum uric acid >7.0 to ≤9.0 mg/dL) at risk for cerebral, cardiovascular, or renal disease, defined by the presence of hypertension, Type 2 diabetes, renal disease, or history of cerebral or cardiovascular disease, were randomized to febuxostat and non-febuxostat groups and were observed for 36 months. Cerebral, cardiovascular, and renal events and all deaths were defined as the primary composite event. The serum uric acid level at endpoint (withdrawal or completion of the study) in the febuxostat (n = 537) and non-febuxostat groups (n = 533) was 4.50 ± 1.52 and 6.76 ± 1.45 mg/dL, respectively (P < 0.001). The primary composite event rate was significantly lower in the febuxostat group than in non-febuxostat treatment [hazard ratio (HR) 0.750, 95% confidence interval (CI) 0.592-0.950; P = 0.017] and the most frequent event was renal impairment (febuxostat group: 16.2%, non-febuxostat group: 20.5%; HR 0.745, 95% CI 0.562-0.987; P = 0.041).
CONCLUSION
Febuxostat lowers uric acid and delays the progression of renal dysfunction.
REGISTRATION
ClinicalTrials.gov (NCT01984749).",2019,"The primary composite event rate was significantly lower in the febuxostat group than in non-febuxostat treatment [hazard ratio (HR) 0.750, 95% confidence interval (CI) 0.592-0.950; P = 0.017] and the most frequent event was renal impairment (febuxostat group: 16.2%, non-febuxostat group: 20.5%; HR 0.745, 95% CI 0.562-0.987; P = 0.041).
","['A total of 1070 patients were included in the intention-to-treat population', 'Elderly patients with hyperuricaemia (serum uric acid >7.0 to ≤9.0\u2009mg/dL) at risk for cerebral, cardiovascular, or renal disease, defined by the presence of hypertension, Type 2 diabetes, renal disease, or history of cerebral or cardiovascular disease', '141 hospitals in Japan', 'patients with hyperuricaemia treated with febuxostat and those treated with conventional therapy with lifestyle modification']","['Febuxostat', 'febuxostat and non-febuxostat', 'febuxostat']","['occurrence of cerebral, cardiovascular, and renal events', 'primary composite event rate', 'serum uric acid level', 'Cerebral, cardiovascular, and renal events and all deaths']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1070.0,0.060699,"The primary composite event rate was significantly lower in the febuxostat group than in non-febuxostat treatment [hazard ratio (HR) 0.750, 95% confidence interval (CI) 0.592-0.950; P = 0.017] and the most frequent event was renal impairment (febuxostat group: 16.2%, non-febuxostat group: 20.5%; HR 0.745, 95% CI 0.562-0.987; P = 0.041).
","[{'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Department of General Internal Medicine 3, Kawasaki Medical School General Center, 2-6-1 Nakasange, Kita-ku, Okayama, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of Family, Community, and General Medicine, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Hiramitsu', 'Affiliation': 'Hiramitsu Heart Clinic, 2-35 Shiroshita-cho, Minami-ku, Nagoya, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Hisatome', 'Affiliation': 'Institute of Regenerative Medicine and Biofunction, Tottori University Graduate School of Medical Science, 86 Nishi-machi, Yonago, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Shizuoka City Shizuoka Hospital, 10-93 Ote-machi, Aoi-ku, Shizuoka, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Uchiyama', 'Affiliation': 'Uchiyama Clinic, 1161-1 Shita-machi, Yoshikawa-ku, Joetsu, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Yokota', 'Affiliation': 'Yokota Naika, 642-1 Komuta, Hanagashima-cho, Miyazaki, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Tokutake', 'Affiliation': 'Tokutake Iin, 2-28-1 Asahi, Kawaguchi, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Wakasa', 'Affiliation': 'Wakasa Medical Clinic, 3-16-25 Sainen, Kanazawa, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Jinnouchi Hospital Diabetes Care Center, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Kakuda', 'Affiliation': 'Kakuda Iin, Na 15-1, Takamatsu, Kahoku, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Medical Clinic, 5-22 Nakamozu-cho, Kita-ku, Sakai, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kawai', 'Affiliation': 'Kawai Naika Clinic, 4-9 Tono-machi, Gifu, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Yokohama Sotetsu Bldg Clinic of Internal Medicine, 1-11-5 Kitasaiwai, Nishi-ku, Yokohama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sugawara', 'Affiliation': 'Sugawara Clinic, 3-9-16 Shakujii-machi, Nerima-ku, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Ohya', 'Affiliation': 'Department of Cardiovascular Medicine, Nephrology and Neurology, University of the Ryukyus School of Medicine, 207 Uehara, Nishihara-cho, Okinawa, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, 840 Shijyo-cho, Kashihara, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Japan.'}]",European heart journal,['10.1093/eurheartj/ehz119']
1121,30764736,Impact of aerobic exercise and fatty acid supplementation on global and gene-specific DNA methylation.,"Lifestyle interventions, including exercise and dietary supplementation, can modify DNA methylation and exert health benefits; however, the underlying mechanisms are poorly understood. Here we investigated the impact of acute aerobic exercise and the supplementation of omega-3 polyunsaturated fatty acids (n-3 PUFA) and extra virgin olive oil (EVOO) on global and gene-specific (PPARGC1A, IL6 and TNF) DNA methylation, and DNMT mRNA expression in leukocytes of disease-free individuals. Eight trained male cyclists completed an exercise test before and after a four-week supplementation of n-3 PUFA and EVOO in a double-blind, randomised, repeated measures design. Exercise triggered global hypomethylation (Pre 79.2%; Post 78.7%; p = 0.008), alongside, hypomethylation (Pre 6.9%; Post 6.3%; p < 0.001) and increased mRNA expression of PPARGC1A (p < 0.001). Associations between PPARGC1A methylation and exercise performance were also detected. An interaction between supplement and trial was detected for a single CpG of IL6 indicating increased DNA methylation following n-3 PUFA and decreased methylation following EVOO (p = 0.038). Global and gene-specific DNA methylation associated with markers of inflammation and oxidative stress. The supplementation of EVOO reduced DNMT1 mRNA expression compared to n-3 PUFA supplementation (p = 0.048), whereas, DNMT3a (p = 0.018) and DNMT3b (p = 0.046) mRNA expression were decreased following exercise. In conclusion, we demonstrate that acute exercise and dietary supplementation of n-3 PUFAs and EVOO induce DNA methylation changes in leukocytes, potentially via the modulation of DNMT mRNA expression. Future studies are required to further elucidate the impact of lifestyle interventions on DNA methylation.",2019,"Exercise triggered global hypomethylation (Pre 79.2%; Post 78.7%; p = 0.008), alongside, hypomethylation (Pre 6.9%; Post 6.3%; p < 0.001) and increased mRNA expression of PPARGC1A (p < 0.001).","['Eight trained male cyclists', 'leukocytes of disease-free individuals']","['Lifestyle interventions, including exercise and dietary supplementation', 'n-3 PUFA and EVOO', 'aerobic exercise and fatty acid supplementation', 'acute aerobic exercise and the supplementation of omega-3 polyunsaturated fatty acids (n-3 PUFA) and extra virgin olive oil (EVOO', 'n-3 PUFA supplementation']","['Exercise triggered global hypomethylation', 'mRNA expression of PPARGC1A', 'global and gene-specific DNA methylation', 'global and gene-specific (PPARGC1A, IL6 and TNF) DNA methylation, and DNMT mRNA expression', 'mRNA expression']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",8.0,0.099747,"Exercise triggered global hypomethylation (Pre 79.2%; Post 78.7%; p = 0.008), alongside, hypomethylation (Pre 6.9%; Post 6.3%; p < 0.001) and increased mRNA expression of PPARGC1A (p < 0.001).","[{'ForeName': 'David John', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'a Translational Chemical Biology Research Group, School of Sport, Exercise and Health Sciences , Loughborough University , Loughborough , UK.'}, {'ForeName': 'Lynsey', 'Initials': 'L', 'LastName': 'James', 'Affiliation': 'a Translational Chemical Biology Research Group, School of Sport, Exercise and Health Sciences , Loughborough University , Loughborough , UK.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Hussey', 'Affiliation': 'a Translational Chemical Biology Research Group, School of Sport, Exercise and Health Sciences , Loughborough University , Loughborough , UK.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Wadley', 'Affiliation': 'b National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences , Loughborough University , Loughborough , UK.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Lindley', 'Affiliation': 'a Translational Chemical Biology Research Group, School of Sport, Exercise and Health Sciences , Loughborough University , Loughborough , UK.'}, {'ForeName': 'Sarabjit S', 'Initials': 'SS', 'LastName': 'Mastana', 'Affiliation': 'a Translational Chemical Biology Research Group, School of Sport, Exercise and Health Sciences , Loughborough University , Loughborough , UK.'}]",Epigenetics,['10.1080/15592294.2019.1582276']
1122,30851032,Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction.,"AIMS
The long-term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with bare-metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown.
METHODS AND RESULTS
We performed a 5-year clinical follow-up of 1157 patients (BES: N = 575 and BMS: N = 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95% confidence interval (CI): 0.39-0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95% CI: 0.22-0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95% CI: 0.25-0.66, P < 0.001). Definite stent thrombosis (ST) was recorded in 2.2% and 3.9% (HR 0.57, 95% CI: 0.28-1.16, P = 0.12) with no differences in rates of very late definite ST (1.3% vs. 1.6%, P = 0.77). Optical coherence tomography showed no difference in the frequency of malapposed stent struts at follow-up (BES 0.08% vs. BMS 0.02%, P = 0.10). Uncovered stent struts were rarely observed but more frequent in BES (2.1% vs. 0.15%, P < 0.001). In the IVUS analysis, there was no positive remodelling in either group (external elastic membrane area change BES: -0.63 mm2, 95% CI: -1.44 to 0.39 vs. BMS -1.11 mm2, 95% CI: -2.27 to 0.04, P = 0.07).
CONCLUSION
Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention. At 13 months, vascular healing in treated culprit lesions was almost complete irrespective of stent type.
CLINICAL TRIAL REGISTRATION
http://www.clinicaltrials.gov. Unique identifier: NCT00962416.",2019,"Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention.","['103 patients', 'patients with ST-segment elevation myocardial infarction (STEMI', 'patients with acute ST-segment elevation myocardial infarction', '1157 patients (BES: N\u2009=\u2009575 and BMS: N\u2009=\u2009582', 'patients with STEMI undergoing primary percutaneous coronary intervention']","['bare-metal stent (BMS', 'intravascular ultrasound (IVUS) and optical coherence tomography', 'biodegradable polymer-based biolimus-eluting stents with bare-metal stents', 'biolimus-eluting stents (BESs) with biodegradable polymer']","['Definite stent thrombosis (ST', 'ischaemia-driven target lesion revascularization', 'vascular healing', '5-year rate of MACE', 'risk of major adverse cardiac events', 'rates of very late definite ST', 'frequency of malapposed stent struts', 'BES', 'positive remodelling']","[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",1157.0,0.305327,"Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention.","[{'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Yamaji', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Sygehusvej 10, Roskilde, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Queen Mary University of London, London, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Roffi', 'Affiliation': 'Division of Cardiology, University Hospital, Rue Gabrielle Perret-Gentil 4, Geneva, Switzerland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Koningsplein 1, Enschede, the Netherlands.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Taniwaki', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Moschovitis', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Zaugg', 'Affiliation': 'Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Mittelstrasse 43, Bern, Switzerland.'}, {'ForeName': 'Miodrag', 'Initials': 'M', 'LastName': 'Ostojic', 'Affiliation': 'Cardiology Clinic, Clinical Center of Serbia, Visegradska 26, Belgrade, Serbia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pedrazzini', 'Affiliation': 'Department of Cardiology, Cardiocentro, Via Tesserete 46, Lugano, Switzerland.'}, {'ForeName': 'Dimitrios-Alexios', 'Initials': 'DA', 'LastName': 'Karagiannis-Voules', 'Affiliation': 'Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Mittelstrasse 43, Bern, Switzerland.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Lüscher', 'Affiliation': 'Center for Molecular Cardiology, Schlieren Campus, University of Zurich, Wagistrasse 12, Schlieren, Switzerland.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petach Tikva, Tel Aviv University, Jabotinsky Street 39, Petah Tikwa, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tüller', 'Affiliation': 'Cardiology Department, Triemlispital, Birmensdorferstrasse 497, Zurich, Switzerland.'}, {'ForeName': 'Vladan', 'Initials': 'V', 'LastName': 'Vukcevic', 'Affiliation': 'Cardiology Clinic, Clinical Center of Serbia, Visegradska 26, Belgrade, Serbia.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Mittelstrasse 43, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}]",European heart journal,['10.1093/eurheartj/ehz074']
1123,31221722,"Botulinum neurotoxin treatment in jerky and tremulous functional movement disorders: a double-blind, randomised placebo-controlled trial with an open-label extension.","OBJECTIVE
To study the effect of botulinum neurotoxin (BoNT) treatment in jerky and tremulous functional movement disorders (FMD).
METHODS
Patients with invalidating, chronic (>1 year) symptoms were randomly assigned to two subsequent treatments with BoNT or placebo every 3 months with stratification according to symptom localisation. Improvement on the dichotomised Clinical Global Impression-Improvement scale (CGI-I) (improvement vs no change or worsening) at 4 months, assessed by investigators blinded to the allocated treatment was the primary outcome. Subsequently all patients were treated with BoNT in a ten month open-label phase.
RESULTS
Between January 2011 and February 2015 a total of 239 patients were screened for eligibility of whom 48 patients were included. No difference was found on the primary outcome (BoNT 16 of 25 (64.0%) vs Placebo 13 of 23 patients (56.5%); proportional difference 0.075 (95% CI -0.189 to 0.327; p=0.77). Secondary outcomes (symptom severity, disease burden, disability, quality of life and psychiatric symptoms) showed no between-group differences. The open-label phase showed improvement on the CGI-I in 19/43 (44.2%) of remaining patients, with a total of 35/43 (81.4%) improvement compared with baseline.
CONCLUSIONS
In this double-blind randomised controlled trial of BoNT for chronic jerky and tremulous FMD, we found no evidence of improved outcomes compared with placebo. Motor symptoms improved in a large proportion in both groups which was sustained in the open-label phase. This study underlines the substantial potential of chronic jerky and tremulous FMD patients to recover and may stimulate further exploration of placebo-therapies in these patients.
TRIAL REGISTRATION NUMBER
NTR2478.",2019,Improvement on the dichotomised Clinical Global Impression-Improvement scale (CGI-I),"['jerky and tremulous functional movement disorders', 'jerky and tremulous functional movement disorders (FMD', 'Between January 2011 and February 2015 a total of 239 patients were screened for eligibility of whom 48 patients were included', 'Patients with invalidating, chronic (>1\u2009year']","['botulinum neurotoxin (BoNT', 'BoNT or placebo', 'placebo', 'Botulinum neurotoxin']","['dichotomised Clinical Global Impression-Improvement scale (CGI-I', 'CGI', 'Motor symptoms', 'Secondary outcomes (symptom severity, disease burden, disability, quality of life and psychiatric symptoms']","[{'cui': 'C4273557', 'cui_str': 'Functional movement disorder'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1295507', 'cui_str': 'Botulinum neurotoxin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}]",239.0,0.657225,Improvement on the dichotomised Clinical Global Impression-Improvement scale (CGI-I),"[{'ForeName': 'Yasmine Emma Maria', 'Initials': 'YEM', 'LastName': 'Dreissen', 'Affiliation': 'Neurology and Clinical Neurophysiology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Joke M', 'Initials': 'JM', 'LastName': 'Dijk', 'Affiliation': 'Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Gelauff', 'Affiliation': 'Neurology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Zoons', 'Affiliation': 'Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'van Poppelen', 'Affiliation': 'Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Maria Fiorella', 'Initials': 'MF', 'LastName': 'Contarino', 'Affiliation': 'Neurology, Haga Teaching Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Rodi', 'Initials': 'R', 'LastName': 'Zutt', 'Affiliation': 'Neurology, Universitair Medisch Centrum Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Post', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Munts', 'Affiliation': 'Neurology, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Speelman', 'Affiliation': 'Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Cath', 'Affiliation': 'Department of Clinical and Health Psychology, Altrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'de Haan', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes Htm', 'Initials': 'JH', 'LastName': 'Koelman', 'Affiliation': 'Neurology and Clinical Neurophysiology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marina A J', 'Initials': 'MAJ', 'LastName': 'Tijssen', 'Affiliation': 'Neurology, Universitair Medisch Centrum Groningen, Groningen, The Netherlands m.a.j.de.koning-tijssen@umcg.nl.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2018-320071']
1124,31181244,Simultaneously applying cathodal tDCS with low frequency rTMS at the motor cortex boosts inhibitory aftereffects.,"BACKGROUND
Transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) can modulate cortical excitability. However, the combining effect of tDCS and rTMS at the same motor cortex is unknown.
NEW METHODS
We have recently developed a new stimulation protocol that simultaneously combines two well-documented methods. Eleven right-handed healthy subjects undertook four sessions at the left cortical representation area of right first dorsal interosseous muscle in randomized order, the order was counter balanced. Session one was the sham control without tDCS or rTMS. Session two involved cathodal tDCS with sham rTMS. Session three involved rTMS with sham tDCS. Session four was the combination of cathodal tDCS and rTMS(tDCS-rTMS). Cathodal tDCS was applied at 1 mA, and 1200 rTMS pulses were applied at 1 Hz with 90% resting motor threshold (RMT). All stimulation durations lasted for 20 min. RMT was monitored pre- and post-stimulation immediately after finishing the stimulation. Single pulse TMS induced MEP amplitudes were monitored before and after stimulation for 30 min afterwards.
RESULTS
Neither stimulus modality changed the value of RMT. As compared to sham stimulation, MEP amplitudes decreased in other three conditions. MEP amplitudes in tDCS-rTMS were much more inhibited than either tDCS or rTMS alone.
COMPARISON WITH EXISTING METHODS
We could reproduce inhibitory effect of 1 mA cathodal tDCS and 1 Hz rTMS in concordance with previous literature. The novel simultaneous tDCS-rTMS stimulation protocol can induce enhanced excitability change than either tDCS or rTMS.
CONCLUSIONS
Simultaneous application of cathodal tDCS with low frequency rTMS produces a stronger inhibitory effect.",2019,"As compared to sham stimulation, MEP amplitudes decreased in other three conditions.",['Eleven right-handed healthy subjects'],"['Cathodal tDCS', 'RMT', 'Transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS', 'cathodal tDCS and rTMS(tDCS-rTMS', 'tDCS and rTMS', 'rTMS with sham tDCS', 'cathodal tDCS with sham rTMS', 'tDCS or rTMS', 'sham control without tDCS or rTMS']",['MEP amplitudes'],"[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0277914,"As compared to sham stimulation, MEP amplitudes decreased in other three conditions.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhexue', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Penghui', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qilin', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yicong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. Electronic address: linyc_1@163.com.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Center of Epilepsy, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China. Electronic address: wangyuping01@sina.cn.'}]",Journal of neuroscience methods,['10.1016/j.jneumeth.2019.05.017']
1125,31658994,"Phase II Trial of Ipilimumab with Stereotactic Radiation Therapy for Metastatic Disease: Outcomes, Toxicities, and Low-Dose Radiation-Related Abscopal Responses.","Ipilimumab is effective for patients with melanoma, but not for those with less immunogenic tumors. We report a phase II trial of ipilimumab with concurrent or sequential stereotactic ablative radiotherapy to metastatic lesions in the liver or lung (NCT02239900). Ipilimumab (every 3 weeks for 4 doses) was given with radiotherapy begun during the first dose (concurrent) or 1 week after the second dose (sequential) and delivered as 50 Gy in 4 fractions or 60 Gy in 10 fractions to metastatic liver or lung lesions. In total, 106 patients received ≥1 cycle of ipilimumab with radiation. Median follow-up was 10.5 months. Median progression-free survival time was 2.9 months (95% confidence interval, 2.45-3.40), and median overall survival time was not reached. Rates of clinical benefit of nonirradiated tumor volume were 26% overall, 28% for sequential versus 20% for concurrent therapy ( P = 0.250), and 31% for lung versus 14% for liver metastases ( P = 0.061). The sequential lung group had the highest rate of clinical benefit at 42%. There were no differences in treatment-related adverse events between groups. Exploratory analysis of nontargeted lesions revealed that lesions receiving low-dose radiation were more likely to respond than those that received no radiation (31% vs. 5%, P = 0.0091). This phase II trial of ipilimumab with stereotactic radiotherapy describes satisfactory outcomes and low toxicities, lending support to further investigation of combined-modality therapy for metastatic cancers.",2019,Median progression-free survival time was 2.9 months (95% confidence interval 2.45-3.40) and median overall survival time was not reached.,"['patients with melanoma', 'Metastatic Disease']","['ipilimumab with concurrent or sequential stereotactic ablative radiation therapy', 'Ipilimumab with Stereotactic Radiation Therapy', 'Ipilimumab', 'ipilimumab with radiation']","['treatment-related adverse events', 'highest rate of clinical benefit', 'median overall survival time', 'Median progression-free survival time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C4552093', 'cui_str': 'Stereotactic Radiation Therapy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",106.0,0.0296904,Median progression-free survival time was 2.9 months (95% confidence interval 2.45-3.40) and median overall survival time was not reached.,"[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. jwelsh@mdanderson.org.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'de Groot', 'Affiliation': 'Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Naing', 'Affiliation': 'Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Hess', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Vassiliki A', 'Initials': 'VA', 'LastName': 'Papadimitrakopoulou', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Taylor R', 'Initials': 'TR', 'LastName': 'Cushman', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Subbiah', 'Affiliation': 'Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Joe Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Simon', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rishab', 'Initials': 'R', 'LastName': 'Ramapriyan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Hampartsoum B', 'Initials': 'HB', 'LastName': 'Barsoumian', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Menon', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Maria Angelica', 'Initials': 'MA', 'LastName': 'Cortez', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Erminia', 'Initials': 'E', 'LastName': 'Massarelli', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Padmanee', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Genitouirinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Allison', 'Affiliation': 'Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Diab', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Raju', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Sherif G', 'Initials': 'SG', 'LastName': 'Shaaban', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Dadu', 'Affiliation': 'Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Cabanillas', 'Affiliation': 'Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Clark', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Gomez', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hahn', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ritsuko', 'Initials': 'R', 'LastName': 'Komaki', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hong', 'Affiliation': 'Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Cancer immunology research,['10.1158/2326-6066.CIR-18-0793']
1126,31205329,Clinical Pharmacist Impact on Intensive Care Unit Delirium: Intervention and Monitoring.,"Purpose: The purpose of this study was to determine the impact of pharmacist monitoring with a clinical decision support system (CDSS) on clinical outcomes related to intensive care unit (ICU) delirium. Methods: This was a single-center, before-and-after study. This study compares patient outcomes of the preintervention group, which is the standard of care of pharmacist rounding, and the intervention group of pharmacy rounding with the CDSS rules. Using a CDSS, specific delirium risk factor rules were created to alert pharmacists to patients who have an increased risk of developing ICU delirium. Patients were included in the study if they were ⩾18 years of age, admitted to the trauma intensive care unit (TICU), and had one of the CDSS rule alerts. The CDSS notified pharmacists in real time to patients in the intervention group that met these criteria to provide timely recommendations in an effort to prevent ICU delirium. Results: Compared with the preintervention group receiving the standard of care (n = 28), the intervention CDSS group (n = 33) had a nonsignificant trend in decreased incidence of delirium (33.3% vs 24.1%, P = .45), ICU length of stay (LOS) (10.11 vs 7.55 days, P = .26), and ventilator duration (7.11 vs 5.03 days, P = .26). The intervention group had a significantly shorter hospital LOS (14.74 vs 9.98 days, P = .04). There was a nonsignificant increase in mortality with the intervention group from nondelirium causes (24.2% vs 7%, P = .07). Conclusion: The utilization of a CDSS by clinical pharmacists to monitor for delirium-specific risk factors led to a significantly shorter hospital LOS. Further studies using this model are warranted to see the impact on the ICU population.",2019,"The intervention group had a significantly shorter hospital LOS (14.74 vs 9.98 days, P = .04).","['Patients were included in the study if they were ⩾18 years of age, admitted to the trauma intensive care unit (TICU), and had one of the CDSS rule alerts']",['pharmacist monitoring with a clinical decision support system (CDSS'],"['shorter hospital LOS', 'ICU length of stay (LOS', 'incidence of delirium', 'mortality', 'ventilator duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4047661', 'cui_str': 'Trauma ICU'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",33.0,0.0872783,"The intervention group had a significantly shorter hospital LOS (14.74 vs 9.98 days, P = .04).","[{'ForeName': 'Myaa', 'Initials': 'M', 'LastName': 'Lightfoot', 'Affiliation': 'TriStar Skyline Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sanders', 'Affiliation': 'TriStar Skyline Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Burke', 'Affiliation': 'TriStar Skyline Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Patton', 'Affiliation': 'TriStar Skyline Medical Center, Nashville, TN, USA.'}]",Hospital pharmacy,['10.1177/0018578718778226']
1127,30843441,Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial.,"BACKGROUND
Transvenous embolisation is a promising technique but the benefits remain uncertain. We hypothesised that transvenous embolisation leads to a higher rate of arteriovenous malformation angiographic occlusion than transarterial embolisation.
METHODS
The Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM) is an investigator initiated, multicentre, prospective, phase 2, randomised controlled clinical trial. To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm). The primary endpoint of the trial is complete arteriovenous malformation occlusion, assessed by catheter cerebral angiography. Complete occlusions will be confirmed at 3 months, while incompletely occluded arteriovenous malformations, considered treatment failures, will then be eligible for complementary treatments by surgery, radiation therapy, or even transvenous embolisation. Standard procedural safety outcomes will also be assessed. Patient selection will be validated by a case selection committee, and participating centres with limited experience in transvenous embolisation will be proctored.
DISCUSSION
The TATAM trial is a transparent research framework designed to offer a promising but still unvalidated treatment to selected arteriovenous malformation patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03691870.",2019,"To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm).","['cerebral Arteriovenous Malformations (TATAM', '76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy']","['Transvenous Approach', 'transvenous embolisation', 'transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm']","['complete arteriovenous malformation occlusion, assessed by catheter cerebral angiography']","[{'cui': 'C0917804', 'cui_str': 'Arteriovenous Malformations, Cerebral'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003857', 'cui_str': 'Arteriovenous Malformations'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0522521', 'cui_str': 'Transvenous approach (qualifier value)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C3163695', 'cui_str': 'Transarterial embolization'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0003857', 'cui_str': 'Arteriovenous Malformations'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0007767', 'cui_str': 'Cerebral Angiography'}]",76.0,0.12336,"To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fahed', 'Affiliation': '1 Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France.'}, {'ForeName': 'Tim E', 'Initials': 'TE', 'LastName': 'Darsaut', 'Affiliation': '2 Department of Surgery, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Mounayer', 'Affiliation': '3 Service de Neuroradiologie, CHU Dupuytren, Service de Neuroradiologie, Limoges, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Chapot', 'Affiliation': '4 Department of Neuroradiology, Alfried-Krupp Krankenhaus Hospital, Essen, Germany.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': '1 Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': '1 Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Mendes Pereira', 'Affiliation': '5 Department of Medical Imaging, Toronto Western Hospital, Toronto, Canada.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Abud', 'Affiliation': '6 Division of Interventional Neuroradiology, Medical School of Ribeirão Preto, University of São Paulo, Brazil.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Iancu', 'Affiliation': ""7 Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Weill', 'Affiliation': ""7 Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': ""7 Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Nico', 'Affiliation': ""7 Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Nolet', 'Affiliation': ""8 Interventional Neuroradiology Laboratory, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}, {'ForeName': 'Guylaine', 'Initials': 'G', 'LastName': 'Gevry', 'Affiliation': ""8 Interventional Neuroradiology Laboratory, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': ""7 Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}]","Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences",['10.1177/1591019918821738']
1128,31773444,"Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex: A Secondary Analysis of Clinical Trial Data.","In a sample of people with HIV (PWH) enrolled in an alcohol intervention trial and followed for 12 months, we examined the association of changes in days (i.e., decrease, increase, no change [reference]) of unhealthy drinking (consuming ≥ 4/≥ 5 drinks for women/men) with antiretroviral therapy adherence (≥ 95% adherent), viral suppression (HIV RNA < 75 copies/mL), condomless sex with HIV-negative/unknown status partners, and dual-risk outcome (HIV RNA ≥ 75 copies/mL plus condomless sex). The sample included 566 PWH (96.8% male; 63.1% White; 93.9% HIV RNA < 75 copies/mL) who completed baseline, 6-, and 12-month assessments. Decrease in days of unhealthy drinking was associated with increased likelihood of viral suppression (odds ratio [OR] 3.78; 95% confidence interval [CI] 1.06, 13.51, P = .04) versus no change. Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001). Neither increase nor decrease were associated with adherence or dual-risk outcome. On a continuous scale, for each increase by 1 day of unhealthy drinking in the prior month, the odds of being 95% adherent decreased by 6% (OR 0.94, 95% CI 0.88, 1.00, P = 0.04).",2020,"Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001).","['for women/men) with antiretroviral therapy adherence (≥\u200995% adherent), viral suppression (HIV RNA\u2009<\u200975 copies/mL), condomless sex with HIV-negative/unknown status partners, and dual-risk outcome (HIV RNA\u2009≥\u200975 copies/mL plus condomless sex', 'The sample included 566 PWH (96.8% male; 63.1% White; 93.9% HIV RNA\u2009<\u200975 copies/mL) who completed baseline, 6-, and 12-month assessments', 'people with HIV (PWH']",['unhealthy drinking (consuming\u2009≥\u20094/≥\u20095 drinks'],"['adherence or dual-risk outcome', 'likelihood of viral suppression', 'Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex', 'likelihood of condomless sex']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",566.0,0.042416,"Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001).","[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Varada', 'Initials': 'V', 'LastName': 'Sarovar', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leyden', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Department of Adult and Family Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Catz', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California at Davis, Sacramento, CA, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Williams', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound, Seattle, WA, USA.'}, {'ForeName': 'J Carlo', 'Initials': 'JC', 'LastName': 'Hojilla', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Horberg', 'Affiliation': 'Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, Rockville, MD, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverberg', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02742-y']
1129,31773688,Correlation between gene polymorphism and opioid efficacy in patients with gastric or intestinal cancer.,"OBJECTIVE
To explore the correlation between gene polymorphism and opioid efficacy in patients with gastric or intestinal cancer.
PATIENTS AND METHODS
Fifty-nine patients who underwent laparoscopic surgery for gastric or intestinal cancer under general anesthesia were included and randomly divided into oxycodone (n=30) and sufentanil groups (n=29) by reproducible random number generation method. Single nucleotide polymorphisms (SNPs) of four alleles: μ-opioid receptor gene OPRM1 A118G, cytochrome P450 (CPY450) enzyme system: CPY3A4*1G, CYP3A5*3, and CYP2D6*10 were detected by PCR-pyrosequencing. Patients in sufentanil group received intravenous sufentanil injection during anesthesia induction, intraoperative maintenance, and postoperative analgesia, while those in oxycodone group received oxycodone. Patients' postoperative VAS score, opioid use, and prevalence of adverse reactions were recorded.
RESULTS
The genotype distribution of OPRM1 A118G, CYP3A4*1G, CYP3A5*3, and CYP2D6*10 in Chinese gastric cancer/intestinal cancer patients accorded with the Hardy-Weinberg law (p>0.05). OPRM1 A118G polymorphism correlated with postoperative VAS score and medication dosage, in oxycodone group (p<0.05), while it didn't with those of sufentanil group. The VAS scores in GG group were higher than that in AA group and AG group at T6-T9, (p<0.05); the postoperative pain remedies times in GG group were more than that in the AA and AG groups (p=0.002). CYP3A4*1G polymorphism related to postoperative VAS score, medication dosage and prevalence of adverse reactions in sufentanil group (p<0.05), while it didn't with those of oxycodone group (p>0.05). The total intraoperative medication in AA group was less than that in GG and GA groups (p<0.01), with a higher prevalence of respiratory depression (p=0.01). Nor was there any correlation of CYP3A5*3 and CYP2D6*10 polymorphisms with the efficacy, postoperative VAS score, pain remedies times, postoperative 24 h medication dosage, or prevalence of adverse reactions in oxycodone and sufentanil groups.
CONCLUSIONS
Gene polymorphism affects the efficacy and adverse reactions of opioids in patients undergoing laparoscopic gastric or intestinal cancer surgery.",2019,"The total intraoperative medication in AA group was less than that in GG and GA groups (p<0.01), with a higher prevalence of respiratory depression (p=0.01).","['patients with gastric or intestinal cancer', 'patients undergoing laparoscopic gastric or intestinal cancer surgery', 'Single nucleotide polymorphisms (SNPs) of four alleles', 'Chinese gastric cancer/intestinal cancer patients accorded with the Hardy-Weinberg law (p>0.05', 'for gastric or intestinal cancer under general anesthesia', 'Fifty-nine patients who underwent']","['μ-opioid receptor gene OPRM1 A118G, cytochrome P450 (CPY450) enzyme system', 'oxycodone', 'laparoscopic surgery', 'sufentanil', 'oxycodone group received oxycodone', 'CYP3A4', 'OPRM1', 'intravenous sufentanil injection']","['respiratory depression', 'postoperative pain remedies times', 'postoperative VAS score', 'VAS scores', 'postoperative VAS score, opioid use, and prevalence of adverse reactions', 'total intraoperative medication', 'efficacy, postoperative VAS score, pain remedies times, postoperative 24 h medication dosage, or prevalence of adverse reactions', 'postoperative VAS score, medication dosage and prevalence of adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0220866', 'cui_str': 'laws'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}]","[{'cui': 'C0034801', 'cui_str': 'Receptors, Opiate'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0010762', 'cui_str': 'Cytochrome P-450 Families'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3714798', 'cui_str': 'CYP3A4'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4283241', 'cui_str': 'Sufentanil Injection'}]","[{'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]",59.0,0.0529667,"The total intraoperative medication in AA group was less than that in GG and GA groups (p<0.01), with a higher prevalence of respiratory depression (p=0.01).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, Shanghai, P.R. China. jfjczyy@163.com.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Z-K', 'Initials': 'ZK', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'X-Y', 'Initials': 'XY', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'H-B', 'Initials': 'HB', 'LastName': 'Yuan', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201911_19432']
1130,31679946,"Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial.","BACKGROUND
Cystic fibrosis transmembrane conductance regulator (CFTR) modulators correct the basic defect caused by CFTR mutations. Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508del mutation. The addition of elexacaftor (VX-445), a next-generation CFTR corrector, to tezacaftor plus ivacaftor further improved F508del-CFTR function and clinical outcomes in a phase 2 study in people with cystic fibrosis homozygous for the F508del mutation.
METHODS
This phase 3, multicentre, randomised, double-blind, active-controlled trial of elexacaftor in combination with tezacaftor plus ivacaftor was done at 44 sites in four countries. Eligible participants were those with cystic fibrosis homozygous for the F508del mutation, aged 12 years or older with stable disease, and with a percentage predicted forced expiratory volume in 1 s (ppFEV 1 ) of 40-90%, inclusive. After a 4-week tezacaftor plus ivacaftor run-in period, participants were randomly assigned (1:1) to 4 weeks of elexacaftor 200 mg orally once daily plus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h versus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h alone. The primary outcome was the absolute change from baseline (measured at the end of the tezacaftor plus ivacaftor run-in) in ppFEV 1 at week 4. Key secondary outcomes were absolute change in sweat chloride and Cystic Fibrosis Questionnaire-Revised respiratory domain (CFQ-R RD) score. This study is registered with ClinicalTrials.gov, NCT03525548.
FINDINGS
Between Aug 3 and Dec 28, 2018, 113 participants were enrolled. Following the run-in, 107 participants were randomly assigned (55 in the elexacaftor plus tezacaftor plus ivacaftor group and 52 in the tezacaftor plus ivacaftor group) and completed the 4-week treatment period. The elexacaftor plus tezacaftor plus ivacaftor group had improvements in the primary outcome of ppFEV 1 (least squares mean [LSM] treatment difference of 10·0 percentage points [95% CI 7·4 to 12·6], p<0·0001) and the key secondary outcomes of sweat chloride concentration (LSM treatment difference -45·1 mmol/L [95% CI -50·1 to -40·1], p<0·0001), and CFQ-R RD score (LSM treatment difference 17·4 points [95% CI 11·8 to 23·0], p<0·0001) compared with the tezacaftor plus ivacaftor group. The triple combination regimen was well tolerated, with no discontinuations. Most adverse events were mild or moderate; serious adverse events occurred in two (4%) participants receiving elexacaftor plus tezacaftor plus ivacaftor and in one (2%) receiving tezacaftor plus ivacaftor.
INTERPRETATION
Elexacaftor plus tezacaftor plus ivacaftor provided clinically robust benefit compared with tezacaftor plus ivacaftor alone, with a favourable safety profile, and shows the potential to lead to transformative improvements in the lives of people with cystic fibrosis who are homozygous for the F508del mutation.
FUNDING
Vertex Pharmaceuticals.",2019,Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508del mutation.,"['107 participants were randomly assigned (55 in the', 'Between Aug 3 and Dec 28, 2018, 113 participants were enrolled', 'Eligible participants were those with cystic fibrosis homozygous for the F508del mutation, aged 12 years or older with stable disease, and with a percentage predicted forced expiratory volume in 1 s (ppFEV 1 ) of 40-90%, inclusive', 'people with cystic fibrosis homozygous for the F508del mutation', 'people with cystic fibrosis who are homozygous for the F508del mutation']","['elexacaftor plus tezacaftor plus ivacaftor group and 52 in the tezacaftor plus ivacaftor', 'elexacaftor', 'tezacaftor plus ivacaftor', 'elexacaftor (VX-445', 'elexacaftor 200 mg orally once daily plus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h versus tezacaftor 100 mg orally once daily plus ivacaftor', 'elexacaftor plus tezacaftor plus ivacaftor combination regimen']","['adverse events', 'ppFEV 1 (least squares mean [LSM] treatment difference of 10·0 percentage points', 'Efficacy and safety', 'sweat chloride concentration (LSM treatment difference -45·1 mmol/L', 'absolute change in sweat chloride and Cystic Fibrosis Questionnaire-Revised respiratory domain (CFQ-R RD) score', 'CFQ-R RD score']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4550902', 'cui_str': 'tezacaftor 100 MG'}, {'cui': 'C3264622', 'cui_str': 'ivacaftor 150 MG'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",113.0,0.337851,Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508del mutation.,"[{'ForeName': 'Harry G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': 'Department of Pulmonology, University Medical Center Utrecht, Utrecht, Netherlands. Electronic address: h.g.m.heijerman@umcutrecht.nl.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'McKone', 'Affiliation': ""St Vincent's University Hospital and University College Dublin School of Medicine, Dublin, Ireland.""}, {'ForeName': 'Damian G', 'Initials': 'DG', 'LastName': 'Downey', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Van Braeckel', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tullis', 'Affiliation': ""Division of Respirology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Mall', 'Affiliation': 'Department of Pulmonology, Immunology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; German Center for Lung Research, Berlin, Germany.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Welter', 'Affiliation': 'Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine, New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, WA, USA.""}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'McKee', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Marigowda', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Moskowitz', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waltz', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Sosnay', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Simard', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Fengjuan', 'Initials': 'F', 'LastName': 'Xuan', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Yaohua', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Taylor-Cousar', 'Affiliation': 'Department of Medicine and Pediatrics, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'McCoy', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Ohio State University, Columbus, OH, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32597-8']
1131,30973790,Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia.,"PURPOSE
Tamoxifen administered for 5 years at 20 mg/d is effective in breast cancer treatment and prevention, but toxicity has limited its broad use. Biomarker trials showed that 5 mg/d is not inferior to 20 mg/d in decreasing breast cancer proliferation. We hypothesized that a lower dose given for a shorter period could be as effective in preventing recurrence from breast intraepithelial neoplasia but have a lower toxicity than the standard dose.
PATIENTS AND METHODS
We conducted a multicenter randomized trial of tamoxifen, 5 mg/d or placebo administered for 3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ. The primary end point was the incidence of invasive breast cancer or ductal carcinoma in situ.
RESULTS
Five hundred women 75 years of age or younger were included. After a median follow-up of 5.1 years (interquartile range, 3.9-6.3 years), there were 14 neoplastic events with tamoxifen and 28 with placebo (11.6 v 23.9 per 1,000 person-years; hazard ratio, 0.48; 95% CI, 0.26 to 0.92; P = .02), which resulted in a 5-year number needed to treat of 22 (95% CI, 20 to 27). Tamoxifen decreased contralateral breast events by 75% (three v 12 events; hazard ratio, 0.25; 95% CI, 0.07 to 0.88; P = .02). Patient-reported outcomes were not different between arms except for a slight increase in frequency of daily hot flashes with tamoxifen ( P = .02). There were 12 serious adverse events with tamoxifen and 16 with placebo, including one deep vein thrombosis and one stage I endometrial cancer with tamoxifen and one pulmonary embolism with placebo.
CONCLUSION
Tamoxifen at 5 mg/d for 3 years can halve the recurrence of breast intraepithelial neoplasia with a limited toxicity, which provides a new treatment option in these disorders.",2019,Patient-reported outcomes were not different between arms except for a slight increase in frequency of daily hot flashes with tamoxifen ( P = .02).,"['3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ', 'Five hundred women 75 years of age or younger were included', 'Breast Intraepithelial Neoplasia']","['Tamoxifen', 'Low-Dose Tamoxifen', 'placebo', 'Placebo', 'tamoxifen, 5 mg/d or placebo', 'tamoxifen']","['contralateral breast events', 'breast cancer proliferation', 'deep vein thrombosis and one stage I endometrial cancer', 'frequency of daily hot flashes', 'Local and Contralateral Recurrence', 'incidence of invasive breast cancer or ductal carcinoma in situ']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442834', 'cui_str': 'Atypical ductal hyperplasia (qualifier value)'}, {'cui': 'C0205417', 'cui_str': 'Lobular (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}]",,0.626096,Patient-reported outcomes were not different between arms except for a slight increase in frequency of daily hot flashes with tamoxifen ( P = .02).,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'DeCensi', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Puntoni', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Aliana', 'Initials': 'A', 'LastName': 'Guerrieri-Gonzaga', 'Affiliation': '3 European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Caviglia', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Avino', 'Affiliation': '4 Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cortesi', 'Affiliation': '5 Azienda Ospedaliera-Universitaria Policlinico di Modena, Modena, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Taverniti', 'Affiliation': '6 Azienda Ospedaliera-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pacquola', 'Affiliation': '7 Ospedale SS Antonio e Margherita-ASL AL, Tortona, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Falcini', 'Affiliation': '8 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Gulisano', 'Affiliation': '9 ULSS 6 Vicenza, Vicenza, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Digennaro', 'Affiliation': '10 IRCCS Istituto Tumori ""Giovanni Paolo II"", Bari, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cariello', 'Affiliation': '11 Azienda Unità Sanitaria Locale della Romagna, Ravenna, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Cagossi', 'Affiliation': '12 Ospedale Bernardino Ramazzini, Carpi, Italy.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Pinotti', 'Affiliation': '13 Azienda Socio-Sanitaria Territoriale Sette Laghi, Varese, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lazzeroni', 'Affiliation': '3 European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Serrano', 'Affiliation': '3 European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Branchi', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Campora', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Petrera', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Buttiron Webber', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': '14 Azienda Ospedaliera-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Bonanni', 'Affiliation': '3 European Institute of Oncology IRCCS, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01779']
1132,31386611,Maintaining Outstanding Outcomes Using Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma: A Report From the Children's Oncology Group Study ANBL0531.,"PURPOSE
The primary objective of the Children's Oncology Group study ANBL0531 (ClinicalTrials.gov identifier: NCT00499616) was to reduce therapy for subsets of patients with intermediate-risk neuroblastoma using a biology- and response-based algorithm to assign treatment duration while maintaining a 3-year overall survival (OS) of 95% or more for the entire cohort.
PATIENTS AND METHODS
Children younger than age 12 years with intermediate-risk stage 2A/2B or stage 3 tumors with favorable histology; infants younger than age 365 days with stage 3, 4 or 4S disease; and toddlers from 365 to younger than 547 days with favorable histology, hyperdiploid stage 4, or unfavorable histology stage 3 tumors were eligible. Patients with MYCN -amplified tumors were excluded. Patients were assigned to initially receive two (group 2), four (group 3), or eight (group 4) cycles of chemotherapy with or without surgery on the basis of prognostic markers, including allelic status of chromosomes 1p and 11q; ultimate duration of therapy was determined by overall response.
RESULTS
Between 2007 and 2011, 404 evaluable patients were enrolled. Compared with legacy Children's Oncology Group studies, subsets of patients had a reduction in treatment. The 3-year event-free survival and OS rates were 83.2% (95% CI, 79.4% to 87.0%) and 94.9% (95% CI, 92.7% to 97.2%), respectively. Infants with stage 4 tumors with favorable biology (n = 61) had superior 3-year event-free survival compared with patients with one or more unfavorable biologic features (n = 47; 86.9% [95% CI, 78.3% to 95.4%] v 66.8% [95% CI, 53.1% to 80.6%]; P = .02), with a trend toward OS advantage (95.0% [95% CI, 89.5% to 100%] v 86.7% [95% CI, 76.6% to 96.7%], respectively; P = .08). OS for patients with localized disease was 100%.
CONCLUSION
Excellent survival was achieved with this treatment algorithm, with reduction of therapy for subsets of patients. More-effective treatment strategies still are needed for infants with unfavorable biology stage 4 disease.",2019,"The 3-year event-free survival and OS rates were 83.2% (95% CI, 79.4% to 87.0%) and 94.9% (95% CI, 92.7% to 97.2%), respectively.","['patients with intermediate-risk neuroblastoma using a biology- and response-based algorithm to assign treatment duration while maintaining a 3-year overall survival (OS) of 95% or more for the entire cohort', 'Children younger than age 12 years with intermediate-risk stage 2A/2B or stage 3 tumors with favorable histology; infants younger than age 365 days with stage 3, 4 or 4S disease; and toddlers from 365 to younger than 547 days with favorable histology, hyperdiploid stage 4, or unfavorable histology stage 3 tumors were eligible', 'Between 2007 and 2011, 404 evaluable patients were enrolled', 'Intermediate-Risk Neuroblastoma', ""Children's Oncology Group"", 'Patients with MYCN', 'patients with localized disease was 100', 'infants with unfavorable biology stage 4 disease']","['Response- and Biology-Based Therapy', 'chemotherapy with or without surgery', 'ANBL0531']","['unfavorable biologic features', '3-year event-free survival and OS rates', 'superior 3-year event-free survival', 'OS advantage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0005532', 'cui_str': 'Biology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002045'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0005532', 'cui_str': 'Biology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",404.0,0.130602,"The 3-year event-free survival and OS rates were 83.2% (95% CI, 79.4% to 87.0%) and 94.9% (95% CI, 92.7% to 97.2%), respectively.","[{'ForeName': 'Clare J', 'Initials': 'CJ', 'LastName': 'Twist', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Schmidt', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': 'Sheena C', 'Initials': 'SC', 'LastName': 'Tenney', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Araz', 'Initials': 'A', 'LastName': 'Marachelian', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Natia', 'Initials': 'N', 'LastName': 'Esiashvili', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'E Stanton', 'Initials': 'ES', 'LastName': 'Adkins', 'Affiliation': 'Palmetto Health-USC Medical Group, Columbia, SC.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mattei', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Handler', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Katzenstein', 'Affiliation': ""Nemours Children's Health Center, Jacksonville, FL.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Attiyeh', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hogarty', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gastier-Foster', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wagner', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Matthay', 'Affiliation': ""University of California, San Francisco, School of Medicine, and UCSF Benioff Children's Hospital, San Francisco, CA.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Maris', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Cohn', 'Affiliation': 'The University of Chicago, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00919']
1133,31220365,The Effect of a Screening and Treatment Program for the Prevention of Fractures in Older Women: A Randomized Pragmatic Trial.,"Population screening for fracture risk may reduce the fracture incidence. In this randomized pragmatic trial, the SALT Osteoporosis Study (SOS), we studied whether screening for fracture risk and subsequent treatment in primary care can reduce fractures compared with usual care. A total of 11,032 women aged 65 to 90 years with ≥1 clinical risk factor for fractures were individually randomized to screening (n = 5575) or usual care (n = 5457). Participants in the screening group underwent a screening program, including bone densitometry and vertebral fracture assessment. Participants with a high 10-year fracture probability (FRAX) or a vertebral fracture were offered treatment with anti-osteoporosis medication by their general practitioner. Incident fractures as reported by questionnaires were verified with medical records. Follow-up was completed by 94% of the participants (mean follow-up = 3.7 years). Of the 5575 participants in the screening group, 1417 (25.4%) had an indication for anti-osteoporosis medication. Screening and subsequent treatment had no statistically significant effect on the primary outcome fracture (hazard ratio [HR] = 0.97; 95% confidence interval [CI] 0.87-1.08), nor on the secondary outcomes osteoporotic fractures (HR = 0.91; 95% CI 0.81-1.03), major osteoporotic fractures (HR = 0.91; 95% CI 0.80-1.04), hip fractures (HR = 0.91; 95% CI 0.71-1.15), falls (odds ratio [OR] = 0.91; 95% CI 0.72-1.15), or mortality (HR = 1.03; 95% CI 0.91-1.17). Post hoc explorative finding suggested that screening might be most effective after a recent fracture (HR = 0.65; 95% CI 0.44-0.96 for major osteoporotic fractures and HR = 0.38; 95% CI 0.18-0.79 for hip fractures). The results of this study might have been compromised by nonparticipation and medication nonadherence in the screening group. Overall, this study does not provide sufficient indications to consider screening for fracture prevention. However, we cannot exclude its clinical relevance to reduce (major) osteoporotic fractures and hip fractures because of the relatively small number of women with a treatment indication in the intervention group. © 2019 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals, Inc.",2019,Post-hoc explorative finding suggested that screening might be most effective after a recent fracture (HR=0.65; 95% CI= 0.44-0.96 for major osteoporotic fractures and HR=0.38; 95% CI=0.18-0.79 for hip fractures).,"['11,032 women aged 65-90 years with ≥1 clinical risk factor for fractures', 'older women', 'Participants with a high 10-year fracture probability (FRAX) or a vertebral fracture were offered treatment with anti-osteoporosis medication by their general practitioner']","['screening (n=5,575) or usual care (n=5,457', 'screening and treatment program', 'screening program, including bone densitometry and vertebral fracture assessment']","['secondary outcomes osteoporotic fractures', 'hip fractures', 'mortality', 'major osteoporotic fractures']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0920149', 'cui_str': 'Bone densitometry'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",11032.0,0.0768,Post-hoc explorative finding suggested that screening might be most effective after a recent fracture (HR=0.65; 95% CI= 0.44-0.96 for major osteoporotic fractures and HR=0.38; 95% CI=0.18-0.79 for hip fractures).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Merlijn', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Karin Ma', 'Initials': 'KM', 'LastName': 'Swart', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Natasja M', 'Initials': 'NM', 'LastName': 'van Schoor', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Martijn W', 'Initials': 'MW', 'LastName': 'Heymans', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Babette C', 'Initials': 'BC', 'LastName': 'van der Zwaard', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Amber A', 'Initials': 'AA', 'LastName': 'van der Heijden', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Rutters', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lips', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Internal Medicine, Endocrine Section, Amsterdam, Netherlands.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Niemeijer', 'Affiliation': 'Stichting Artsen Laboratorium en Trombosedienst, Koog aan de Zaan, Netherlands.'}, {'ForeName': 'J Coen', 'Initials': 'JC', 'LastName': 'Netelenbos', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Internal Medicine, Endocrine Section, Amsterdam, Netherlands.'}, {'ForeName': 'Petra Jm', 'Initials': 'PJ', 'LastName': 'Elders', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3815']
1134,31215805,Urine citrate excretion identifies changes in acid retention as eGFR declines in patients with chronic kidney disease.,"Previous studies have shown that acid (H + ) retention in patients with chronic kidney disease (CKD) but without metabolic acidosis increases as the estimated glomerular filtration rate (eGFR) decreases over time. The present study examined whether changes in urine excretion of the pH-sensitive metabolite citrate predicted changes in H + retention over time in similar patients with CKD that were followed for 10 yr. We randomized 120 CKD2 nondiabetic, hypertension-associated nephropathy patients with plasma total CO 2 of >24 mM to receive 0.5 meq·kg body wt -1 ·day -1 NaHCO 3 ([Formula: see text]; n = 40), 0.5 meq·kg body wt -1 ·day -1 NaCl (NaCl; n = 40), or usual care (UC; n = 40). We assessed eGFR (CKD-EPI) and H + retention by comparing the observed with expected plasma total CO 2 increase 2 h after an oral NaHCO 3 bolus (0.5 meq/kg body wt). Although 10 yr versus baseline eGFR was lower for each group, 10-yr eGFR was higher ( P < 0.01) in [Formula: see text] (59.6 ± 4.8 ml·min -1 ·1.73 m -2 ) than NaCl and UC (52.1 ± 5.9 and 52.3 ± 4.1 ml·min -1 ·1.73 m -2 , respectively) groups. Less eGFR preservation was associated with higher 10-yr versus baseline H + retention in the NaCl group (26.5 ± 13.1 vs. 18.2 ± 15.3 mmol, P < 0.01) and UC group (24.8 ± 11.3 vs. 17.7 ± 10.9 mmol, P < 0.01) and with lower 10-yr versus baseline 8-h urine citrate excretion (U citrate V) for the NaCl group (162 ± 47 vs. 196 ± 52 mg, respectively, P < 0.01) and UC group (153 ± 41 vs. 186 ± 42 mg, respectively, P < 0.01). Conversely, better eGFR preservation in the [Formula: see text] group was associated with no differences in 10-yr versus baseline H + retention (14.2 ±13.5 vs. 16.1 ± 15.1 mmol, P = 1.00) or U citrate V (212 ± 45 vs. 203 ± 49 mg, respectively, P = 0.74). An overall generalized linear model for repeated measures showed that U citrate V predicted H + retention ( P < 0.01). Less eGFR preservation in patients with CKD2 without metabolic acidosis was associated with increased H + retention that was predicted by decreased U citrate V.",2019,An overall generalized linear model for repeated measures showed that U citrate V predicted H + retention (p<0.01).,"['patients with chronic kidney disease (CKD) stage 2 eGFR (60-89 ml ', '120 CKD 2 non-diabetic, hypertension-associated nephropathy patients with plasma total CO 2 (PTCO 2 ) > 24 mM to receive 0.5 mEq/kg bw/day NaHCO 3 (HCO 3 - , n=40), 0.5 mEq/kg bw/day NaCl (NaCl, n=40), or Usual Care (UC, n=40', 'patients with chronic kidney disease']",['min-1.73m-2'],"['acid (H + ) retention', 'eGFR preservation', '10-year eGFR', 'eGFR (CKD-EPI) and H + retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2316786', 'cui_str': 'CKD stage 2'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300572', 'cui_str': 'mEq/kg'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}]",120.0,0.0296586,An overall generalized linear model for repeated measures showed that U citrate V predicted H + retention (p<0.01).,"[{'ForeName': 'Nimrit', 'Initials': 'N', 'LastName': 'Goraya', 'Affiliation': 'Baylor Scott and White Health Department of Internal Medicine, Temple, Texas.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Simoni', 'Affiliation': 'Department of Surgery, Texas Tech University Health Sciences Center, Lubbock, Texas.'}, {'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Sager', 'Affiliation': 'Baylor Scott and White Health Department of Biostatistics, Temple, Texas.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, Texas.'}, {'ForeName': 'Nicolaos E', 'Initials': 'NE', 'LastName': 'Madias', 'Affiliation': ""School of Medicine, Department of Medicine, St. Elizabeth's Medical Center and Tufts University, Boston, Massachusetts.""}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Wesson', 'Affiliation': 'Baylor Scott and White Health Department of Internal Medicine, Dallas, Texas.'}]",American journal of physiology. Renal physiology,['10.1152/ajprenal.00044.2019']
1135,30664524,Comparison of pre-oxygenation using spontaneous breathing through face mask and high-flow nasal oxygen: A randomised controlled crossover study in healthy volunteers.,"BACKGROUND
High-flow nasal oxygen (HFNO) therapy has been proposed for pre-oxygenation before intubation, but the end-tidal fraction of oxygen (ETO2) obtained remains unknown.
OBJECTIVE(S)
To compare the ETO2 following a 3 min pre-oxygenation with HFNO and face mask.
SETTING
Operating room in a primary university hospital.
DESIGN
A randomised crossover study.
PARTICIPANTS
Fifty healthy volunteers.
INTERVENTIONS
Participants were randomly pre-oxygenated through spontaneous breathing 100% oxygen in a face mask and with HFNO (mouth closed, heated and humidified gas flow at 60 l min). In the face mask group, the ETO2 was measured continuously. In the HFNO group, the nasal cannula was quickly exchanged with a face mask while the subject held their breath at end inspiration and the ETO2 was measured after a deep expiration. The protocol ended when ETO2 reached 90% or otherwise at 6 min.
MAIN OUTCOME MEASURES
The primary endpoint was the ETO2 after 3 min of pre-oxygenation. Secondary endpoints were the proportion of participants with an ETO2 at least 90% and the time until the ETO2 at least 90%.
RESULTS
The ETO2 after 3 min of pre-oxygenation was 89 (2) % and 77 (12) % in the face mask and HFNO groups [difference 12% (95% confidence interval, 95% CI: 8 to 15]; P < 0.001), respectively. After 3 min of pre-oxygenation, 54 and 4% (P < 0.001) of volunteers had an ETO2 at least 90% in the face-mask and HFNO groups, respectively. After 6 min of pre-oxygenation, 96 and 46% (P < 0.001) of volunteers had an ETO2 at least 90% in the face-mask and HFNO groups, respectively. In the face mask group, the hazard ratio to achieve an ETO2 of 90% was 5.3 (95% CI: 3.2 to 8.9; P < 0.001).
CONCLUSION
Our study demonstrates that pre-oxygenation with HFNO is not a reliable method of pre-oxygenation before the induction of anaesthesia.
TRIAL REGISTRATION
clinical trial NCT03399695.",2019,"After 3 min of pre-oxygenation, 54 and 4% (P < 0.001) of volunteers had an ETO2 at least 90% in the face-mask and HFNO groups, respectively.","['Operating room in a primary university hospital', 'Fifty healthy volunteers', 'healthy volunteers']","['pre-oxygenation using spontaneous breathing through face mask and high-flow nasal oxygen', 'High-flow nasal oxygen (HFNO) therapy', 'Participants were randomly pre-oxygenated through spontaneous breathing 100% oxygen in a face mask and with HFNO (mouth closed, heated and humidified gas flow', 'HFNO']","['ETO2 after 3\u200amin of pre-oxygenation', 'hazard ratio to achieve an ETO2', 'proportion of participants with an ETO2 at least 90% and the time until the ETO2']","[{'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0180823', 'cui_str': 'Face mask (physical object)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0564684', 'cui_str': 'Mouth closed (finding)'}, {'cui': 'C0428715', 'cui_str': 'Gas flow (observable entity)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",50.0,0.114112,"After 3 min of pre-oxygenation, 54 and 4% (P < 0.001) of volunteers had an ETO2 at least 90% in the face-mask and HFNO groups, respectively.","[{'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': 'From the Department of Anaesthesia and Intensive Care Medicine, Caen University Hospital, Caen, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lhermitte', 'Affiliation': ''}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Gérard', 'Affiliation': ''}, {'ForeName': 'Marc Olivier', 'Initials': 'MO', 'LastName': 'Fischer', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000000954']
1136,31785390,Microfractures Versus a Porcine-Derived Collagen-Augmented Chondrogenesis Technique for Treating Knee Cartilage Defects: A Multicenter Randomized Controlled Trial.,"PURPOSE
The purpose of this study was to evaluate the clinical efficacy and safety of treating patients with a cartilage defect of the knee with microfractures and porcine-derived collagen-augmented chondrogenesis technique (C-ACT).
METHODS
One hundred participants were randomly assigned to the control group (n = 48, microfracture) or the investigational group (n = 52, C-ACT). Clinical and magnetic resonance imaging (MRI) outcomes were assessed 12 and 24 months postoperatively for efficacy and adverse events. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment was used to analyze cartilage tissue repair. MRI outcomes for 50% defect filling and repaired tissue/reference cartilage (RT/RC) ratio were quantified using T2 mapping. Clinical outcomes were assessed using the visual analogue scale (VAS) for pain and 20% improvement, minimal clinically important difference (MCID), and patient acceptable symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee score.
RESULTS
MOCART scores in the investigation group showed improved defect repair and filling (P = .0201), integration with the border zone (P = .0062), and effusion (P = .0079). MRI outcomes showed that the odds ratio (OR) for ≥50% defect filling at 12 months was statistically higher in the investigation group (OR 3.984, P = .0377). Moreover, the likelihood of the RT/RC OR becoming ≥1 was significantly higher (OR 11.37, P = .0126) in the investigation group. At 24 months postoperatively, the OR for the VAS 20% improvement rate was significantly higher in the investigational group (OR 2.808, P = .047). Twenty-three patients (52.3%) in the control group and 35 (77.8%) in the investigation group demonstrated more than the MCID of KOOS pain from baseline to 1 year postoperatively, with a significant difference between groups (P = .0116).
CONCLUSION
In this multicenter randomized trial, the addition of C-ACT resulted in better filling of cartilage defect of the knee joint.
LEVEL OF EVIDENCE
Level Ⅰ, Multicenter Randomized Controlled Trial.",2020,"RESULTS
MOCART scores in the investigation group showed improved defect repair and filling (P = 0.0201), integration with the border zone (P = 0.0062) and effusion (P = 0.0079).","['One hundred participants', 'Treating Knee Cartilage Defects', 'patients with a cartilage defect of the knee with microfractures and']","['porcine-derived collagen-augmented chondrogenesis technique (C-ACT', 'Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment', 'C-ACT', 'Microfractures Versus a Porcine derived Collagen-Augmented Chondrogenesis Technique']","['MCID of KOOS pain', 'defect filling and Repaired Tissue/Reference Cartilage (RT/RC) ratio', 'Clinical and magnetic resonance imaging (MRI) outcomes', 'clinical efficacy and safety', 'Magnetic resonance imaging (MRI) outcomes', 'efficacy and adverse events', 'defect repair and filling', 'odds ratio (OR) for ≥ 50% defect filling', 'odds ratio (OR) for the VAS-20% improvement rate', 'visual analogue scale (VAS)-pain, VAS-20% improvement, minimal clinically important difference (MCID), patient acceptable symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee score']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1265651', 'cui_str': 'Micro Fractures'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0598067', 'cui_str': 'Chondrogenesis'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1265651', 'cui_str': 'Micro Fractures'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}]",100.0,0.174962,"RESULTS
MOCART scores in the investigation group showed improved defect repair and filling (P = 0.0201), integration with the border zone (P = 0.0062) and effusion (P = 0.0079).","[{'ForeName': 'Man Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Churl Hong', 'Initials': 'CH', 'LastName': 'Chun', 'Affiliation': 'Department of Orthopaedic Surgery, Wonkwang University Hospital, College of Medicine, Wonkwang University, Iksan, Korea.'}, {'ForeName': 'Joon Ho', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedic Surgery, Samsung Medical Center, College of Medicine, Sungkyunkwan University of School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Goo', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Seoul Paik Hospital, College of Medicine, Inje University, Seoul, Korea.'}, {'ForeName': 'Seung-Baik', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Doo', 'Initials': 'JD', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopaedic Surgery, Ewha Womans University Mokdong Hospital, College of Medicine, Ewha Womans University, Seoul, Korea.'}, {'ForeName': 'Je-Gyun', 'Initials': 'JG', 'LastName': 'Chon', 'Affiliation': 'Department of Orthopaedic Surgery, Daejeon Sun Hospital, Daejeon, Korea.'}, {'ForeName': 'Myung Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Inha University Hospital, College of Medicine, Inha University, Incheon, Korea.'}, {'ForeName': 'Chan Woong', 'Initials': 'CW', 'LastName': 'Moon', 'Affiliation': ""Department of Orthopaedic Surgery, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea.""}, {'ForeName': 'Chong Bum', 'Initials': 'CB', 'LastName': 'Chang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In Soo', 'Initials': 'IS', 'LastName': 'Song', 'Affiliation': 'Department of Orthopaedic Surgery, Daejeon Sun Hospital, Daejeon, Korea.'}, {'ForeName': 'Jeong Ku', 'Initials': 'JK', 'LastName': 'Ha', 'Affiliation': 'Department of Orthopedic Surgery, Seoul Paik Hospital, College of Medicine, Inje University, Seoul, Korea.'}, {'ForeName': 'Nam Yong', 'Initials': 'NY', 'LastName': 'Choi', 'Affiliation': ""Department of Orthopaedic Surgery, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'In', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. Electronic address: iy1000@catholic.ac.kr.""}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.11.110']
1137,31494070,Dopamine depletion effects on cognitive flexibility as modulated by tDCS of the dlPFC.,"BACKGROUND
Recent evidence suggests that transcranial direct current stimulation (tDCS) may interact with the dopaminergic system to affect cognitive flexibility. Objective/hypotheses: We examined whether putative reduction of dopamine levels through the acute phenylalanine/tyrosine depletion (APTD) procedure and excitatory anodal tDCS of the dorsolateral prefrontal cortex (dlPFC) are causally related to cognitive flexibility as measured by task switching and reversal learning.
METHOD
A double-blind, sham-controlled, randomised trial was conducted to test the effects of combining anodal tDCS and depletion of catecholaminergic precursor tyrosine on cognitive flexibility.
RESULTS
Anodal tDCS and tyrosine depletion had a significant effect on task switching, but not reversal learning. Whilst perseverative errors were significantly improved by anodal tDCS, the APTD impaired reaction times. Importantly, the combination of APTD and anodal tDCS resulted in cognitive performance which did not statistically differ to that of the control condition.
CONCLUSIONS
Our results suggest that the effects of tDCS on cognitive flexibility are modulated by dopaminergic tone.",2020,"Importantly, the combination of APTD and anodal tDCS resulted in cognitive performance which did not statistically differ to that of the control condition.
",[],"['transcranial direct current stimulation (tDCS', 'catecholaminergic precursor tyrosine', 'tDCS']","['task switching', 'reversal learning', 'cognitive performance', 'cognitive flexibility']",[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",,0.0422511,"Importantly, the combination of APTD and anodal tDCS resulted in cognitive performance which did not statistically differ to that of the control condition.
","[{'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Borwick', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Reece', 'Initials': 'R', 'LastName': 'Lal', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Lee Wei', 'Initials': 'LW', 'LastName': 'Lim', 'Affiliation': 'School of Biomedical Sciences, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.'}, {'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Stagg', 'Affiliation': 'Oxford Centre for Human Brain Activity, Wellcome Centre for Integrative Neuroimaging, Department of Psychiatry, University of Oxford, Oxford, UK; MRC Brain Network Dynamics Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Aquili', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK. Electronic address: luca.aquili@shu.ac.uk.'}]",Brain stimulation,['10.1016/j.brs.2019.08.016']
1138,31645305,Rational and design of the T-STORHM Study: A prospective randomized trial comparing fresh whole blood to blood components for acutely bleeding trauma patients.,"Massive hemorrhage remains the main cause of preventable death in combat settings and is also the main cause of year loss in developing countries. The management of these patients relies on blood transfusion and surgery. Time is a key factor, related to survival. Recent events highlight the need to be more efficient in the transfusion supply during terror attacks or mass casualties in civilian settings. Blood components therapy with a 1:1:1 ratio is associated with a decrease of mortality but encounters many logistic issues in those circumstances. Whole blood provides in one bag all the blood components in physiologic proportions with minimal amount of additive solution. Whole blood has been implemented in military as well as civilian settings worldwide. However, direct comparisons with component therapy in prospective clinical trials are scarce. Here we present the rational and the design of the T-STORHM (Trauma-Sang TOtal dans les Hémorragies Massives) trial. This prospective randomized multicentric clinical trial will test low titer group O whole blood to components therapy in the in-hospital management of trauma patients with massive hemorrhage. Sample size calculation, primary and secondary endpoints as trial blood products preparations are discussed. The trial is expected to start in 2019 in 6 civilians and military trauma centers. The French Military Health Service is promoting the study in collaboration with the French transfusion public service (Établissementfrançaisdusang).",2019,Recent events highlight the need to be more efficient in the transfusion supply during terror attacks or mass casualties in civilian settings.,"['trauma patients with massive hemorrhage', 'acutely bleeding trauma patients', '2019 in 6 civilians and military trauma centers']","['low titer group O whole blood to components therapy', 'fresh whole blood to blood components']",[],"[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0333279', 'cui_str': 'Massive hemorrhage (morphologic abnormality)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0427626', 'cui_str': 'Group O (qualifier value)'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0450129', 'cui_str': 'Blood component (substance)'}]",[],,0.0568005,Recent events highlight the need to be more efficient in the transfusion supply during terror attacks or mass casualties in civilian settings.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Martinaud', 'Affiliation': 'French Military Blood Institute, 1, rue Raoul-Batany, 92140 Clamart, France. Electronic address: martinaudctsa@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Tiberghien', 'Affiliation': 'French Blood Establishment, 20, avenue du Stade de France, 93218 Saint-Denis, France. Electronic address: pierre.tiberghien@efs.sante.fr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bégué', 'Affiliation': 'French Blood Establishment, 20, avenue du Stade de France, 93218 Saint-Denis, France. Electronic address: stephane.begue@efs.sante.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sailliol', 'Affiliation': 'French Military Biomedical Research, 91220 Brétigny, France. Electronic address: anne.sailliol@intradef.gouv.fr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gross', 'Affiliation': 'French Blood Establishment, 20, avenue du Stade de France, 93218 Saint-Denis, France. Electronic address: sylvie.gross@gmail.com.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pouget', 'Affiliation': 'French Military Blood Institute, 1, rue Raoul-Batany, 92140 Clamart, France. Electronic address: pougethomas@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ausset', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Percy Military Medical Center, 101, avenue Henri-Barbusse, 92140 Clamart, France. Electronic address: sylvain.ausset@gmail.com.'}]",Transfusion clinique et biologique : journal de la Societe francaise de transfusion sanguine,['10.1016/j.tracli.2019.09.004']
1139,31782747,"[Prescribing physical activity after labour, for women diagnosed with gestational diabetes mellitus].","BACKGROUND
The prevalence of gestational diabetes mellitus (GDM) has been rapidly increasing in Iceland and 19% of women who gave birth at Landspítali - University hospital in 2018 were diagnosed with GDM. Women who develop GDM in pregnancy have an increased risk of recurrence in future pregnancies, as well as an increased risk for developing type 2 diabetes mellitus later in life. Obesity and a sedentary lifestyle are known risk factors for the development of GDM. Prescribing physical activity has become an available treatment option in all Icelandic primary healthcare centres. The aim of this study was to examine the effect of prescribing postpartum exercise for women with a history of GDM on their physical activity level, quality of life, BMI and biochemical markers typical for metabolic syndrome.
MATERIALS AND METHODS
Women who delivered from 1st January 2016 to 30th June 2017 and sought prenatal care at healthcare centres within the Primary Health Care of the Capital Area were offered participation in the study. Participants were randomly divided into two groups, with one group being prescribed physical activity for five months while the other group received standard treatment of care. Blood tests (fasting blood sugar, HbA1c, cholesterol and insulin levels), BMI, general activity level and the patient's quality of life were measured at both three and eight months postpartum.
RESULTS
84 women participated, 45 were assigned to the treatment group and 39 to the control group. General activity levels increased significantly in the treatment group, but no significant changes were seen in their blood test values. The treatment suggested an improvement trend in the women's BMI and quality of life, but the results were not significant. Women who breastfed had significantly lower insulin levels than women not breastfeeding. There was a stronger positive correlation between BMI and insulin levels than between fasting blood sugar levels and insulin levels.
CONCLUSION
Prescribing physical activity after delivery for women with a history of GDM significantly increased their general activity level and breastfeeding seems to have a lowering effect on insulin levels.",2019,"The treatment suggested an improvement trend in the women's BMI and quality of life, but the results were not significant.","['women who gave birth at Landspítali - University hospital in 2018 were diagnosed with GDM', 'gestational diabetes mellitus (GDM', 'Women who delivered from 1st January 2016 to 30th June 2017 and sought prenatal care at healthcare centres within the Primary Health Care of the Capital Area were offered participation in the study', 'women diagnosed with gestational diabetes mellitus', '84 women participated, 45 were assigned to the treatment group and 39 to the control group', 'women with a history of GDM on their']","['standard treatment of care', 'prescribing postpartum exercise']","['physical activity level, quality of life, BMI and biochemical markers typical for metabolic syndrome', 'insulin levels', 'risk of recurrence', 'General activity levels', 'BMI and insulin levels', ""Blood tests (fasting blood sugar, HbA1c, cholesterol and insulin levels), BMI, general activity level and the patient's quality of life"", ""women's BMI and quality of life""]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",2018.0,0.0272644,"The treatment suggested an improvement trend in the women's BMI and quality of life, but the results were not significant.","[{'ForeName': 'Thorunn Johanna', 'Initials': 'TJ', 'LastName': 'Juliusdottir', 'Affiliation': 'Primary Health Care of the Capital Area, Reykjavík, Iceland, University of Iceland.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Hrafnkelsson', 'Affiliation': 'Primary Health Care of the Capital Area, Reykjavík, Iceland, University of Iceland.'}, {'ForeName': 'Ragnheidur I', 'Initials': 'RI', 'LastName': 'Bjarnadottir', 'Affiliation': 'Primary Health Care of the Capital Area, Reykjavík, Iceland, University of Iceland, Development Centre for Primary Healthcare in Iceland.'}, {'ForeName': 'Sesselja', 'Initials': 'S', 'LastName': 'Guðmundsdottir', 'Affiliation': 'Development Centre for Primary Healthcare in Iceland.'}, {'ForeName': 'Ragnheidur', 'Initials': 'R', 'LastName': 'Bachmann', 'Affiliation': 'Primary Health Care of the Capital Area, Reykjavík, Iceland, Development Centre for Primary Healthcare in Iceland.'}, {'ForeName': 'Karitas', 'Initials': 'K', 'LastName': 'Ivarsdottir', 'Affiliation': 'Primary Health Care of the Capital Area, Reykjavík, Iceland, Development Centre for Primary Healthcare in Iceland.'}, {'ForeName': 'Jon Steinar', 'Initials': 'JS', 'LastName': 'Jonsson', 'Affiliation': '1Primary Health Care of the Capital Area, Reykjavík, Iceland, 2University of Iceland, 3Development Centre for Primary Healthcare in Iceland.'}]",Laeknabladid,['10.17992/lbl.2019.12.261']
1140,31192699,The Effects of Caressing and Hugging Infants to Manage the Pain during Venipuncture.,"The aim of this study is to investigate the effects of caressing in infants for pain management during venipuncture. This is a randomized control trial, carried out on 120 infants between 2 and 6 months of age, that included 30 males and 30 females in the hugging and control group, respectively. Parameters such as percentage blood saturation of blood, crying, and the duration of pain felt was evaluated. The venipuncture between the control and experimental groups showed that, less pain is felt by females when caressed by their mother. However, this difference does have statistical significance. Overall, caressing in infants had positive effect on pain-relief after venipuncture.",2020,"The venipuncture between the control and experimental groups showed that, less pain is felt by females when caressed by their mother.","['120 infants between 2 and 6\xa0months of age, that included 30 males and 30 females in the hugging and control group, respectively', 'infants for pain management during venipuncture']",[],"['percentage blood saturation of blood, crying, and the duration of pain felt', 'pain-relief', 'pain']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}]",[],"[{'cui': 'C0005768'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",120.0,0.0328552,"The venipuncture between the control and experimental groups showed that, less pain is felt by females when caressed by their mother.","[{'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Beiranvand', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Lorestan University of Medical Sciences , Khorramabad, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Faraji Goodarzi', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Lorestan University of Medical Sciences , Khorramabad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Firouzi', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Lorestan University of Medical Sciences , Khorramabad, Iran.'}]",Comprehensive child and adolescent nursing,['10.1080/24694193.2019.1609129']
1141,10841126,"Cardiotocography only versus cardiotocography plus PR-interval analysis in intrapartum surveillance: a randomised, multicentre trial. FECG Study Group.","BACKGROUND
There is a need to improve the sensitivity and specificity of fetal monitoring during labour. We compared the gold standard, cardiotocography, with cardiotocography plus time-interval analysis of the fetal electrocardiogram in fetal surveillance. The aim was to find out whether time-interval analysis decreased the need for operative intervention due to fetal distress.
METHODS
We did a randomised, prospective trial in five hospitals in the UK, Hong Kong, the Netherlands, and Singapore. 1038 women undergoing high-risk labours were randomly assigned fetal monitoring by cardiotocography alone, or cardiotocography plus fetal electrocardiography (ECG). Outcomes measured were rates of operative intervention, and neonatal outcome. Analysis was by intention to treat.
FINDINGS
515 women were assigned management by cardiotocography, and 523 cardiotocography plus fetal ECG. There was a trend towards fewer operative interventions for presumed fetal distress in the time-interval analysis plus cardiotocography group (63 [13%] vs 78 [16%]), but this was not significant (relative risk 0.80 [95% CI 0.59-1.08], p=0.17). There was no significant difference between groups in the proportion of babies who had an umbilical arterial pH of 7.15 or less (51 [11%] vs 49 [11%]; 1.01 [0.7-1.47]), or in the frequency of unsuspected acidaemia (42 [9%] vs 35 [8%]; 1.17 [0.76-1.79]).
INTERPRETATION
The addition of time-interval analysis of the fetal electrocardiogram during labour did not show a significant benefit in decreasing operative intervention. There was no significant difference in neonatal outcome.",2000,"There was a trend towards fewer operative interventions for presumed fetal distress in the time-interval analysis plus cardiotocography group (63 [13%] vs 78 [16%]), but this was not significant (relative risk 0.80 [95% CI 0.59-1.08], p=0.17).","['1038 women undergoing high-risk labours', '515 women were assigned management by cardiotocography, and 523', 'five hospitals in the UK, Hong Kong, the Netherlands, and Singapore']","['cardiotocography plus fetal ECG', 'Cardiotocography only versus cardiotocography plus PR-interval analysis', 'gold standard, cardiotocography, with cardiotocography plus time-interval analysis of the fetal electrocardiogram', 'cardiotocography alone, or cardiotocography plus fetal electrocardiography (ECG']","['proportion of babies who had an umbilical arterial pH', 'neonatal outcome', 'fetal distress', 'rates of operative intervention, and neonatal outcome', 'frequency of unsuspected acidaemia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0007208', 'cui_str': 'Electronic Fetal Monitoring'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0007208', 'cui_str': 'Electronic Fetal Monitoring'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0278336', 'cui_str': 'Fetal electrocardiogram (procedure)'}, {'cui': 'C0520877', 'cui_str': 'PR interval feature'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1623258', 'cui_str': 'ECG'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring Fetal Status'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0268030', 'cui_str': 'Acidemia (disorder)'}]",1038.0,0.286224,"There was a trend towards fewer operative interventions for presumed fetal distress in the time-interval analysis plus cardiotocography group (63 [13%] vs 78 [16%]), but this was not significant (relative risk 0.80 [95% CI 0.59-1.08], p=0.17).","[{'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Strachan', 'Affiliation': ""Queen's Medical Centre, Nottingham, UK. bryony.strachan@nottingham.ac.uk""}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'van Wijngaarden', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sahota', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'James', 'Affiliation': ''}]","Lancet (London, England)",[]
1142,32410404,"Human Recombinant Apyrase Therapy Protects Against Myocardial Ischemia/Reperfusion Injury and Preserves Left Ventricular Systolic Function in Rats, as Evaluated by 7T Cardiovascular Magnetic Resonance Imaging.","OBJECTIVE
The occurrence of intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO) in myocardial infarction (MI), known as severe ischemia/reperfusion injury (IRI), has been associated with adverse remodeling. APT102, a soluble human recombinant ecto-nucleoside triphosphate diphosphohydrolase-1, can hydrolyze extracellular nucleotides to attenuate their prothrombotic and proinflammatory effects. The purpose of this study was to temporally evaluate the therapeutic effect of APT102 on IRI in rats and to elucidate the evolution of IRI in the acute stage using cardiovascular magnetic resonance imaging (CMRI).
MATERIALS AND METHODS
Fifty-four rats with MI, induced by ligation of the origin of the left anterior descending coronary artery for 60 minutes, were randomly divided into the APT102 (n = 27) or control (n = 27) group. Intravenous infusion of APT102 (0.3 mg/kg) or placebo was administered 15 minutes before reperfusion, and then 24 hours, 48 hours, 72 hours, and on day 4 after reperfusion. CMRI was performed at 24 hours, 48 hours, 72 hours, and on day 5 post-reperfusion using a 7T system and the hearts were collected for histopathological examination. Cardiac function was quantified using cine imaging and IMH/edema using T2 mapping, and infarct/MVO using late gadolinium enhancement.
RESULTS
The extent of infarction ( p < 0.001), edema ( p < 0.001), IMH ( p = 0.013), and MVO ( p = 0.049) was less severe in the APT102 group than in the control group. IMH size at 48 hours was significantly greater than that at 24 hours, 72 hours, and 5 days after reperfusion (all p < 0.001). The left ventricular ejection fraction (LVEF) was significantly greater in the APT102 group than in the control group ( p = 0.006). There was a negative correlation between LVEF and IMH ( r = -0.294, p = 0.010) and a positive correlation between IMH and MVO ( r = 0.392, p < 0.001).
CONCLUSION
APT102 can significantly alleviate damage to the ischemic myocardium and microvasculature. IMH size peaked at 48 hours post reperfusion and IMH is a downstream consequence of MVO. IMH may be a potential therapeutic target to prevent adverse remodeling in MI.",2020,"IMH size at 48 hours was significantly greater than that at 24 hours, 72 hours, and 5 days after reperfusion (all p < 0.001).","['Fifty-four rats with MI, induced by ligation of the origin of the left anterior descending coronary artery for 60 minutes']","['IMH', 'APT102', 'Human Recombinant Apyrase Therapy', 'placebo']","['intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO', 'Cardiac function', 'LVEF and IMH', 'edema', 'IMH', 'Left Ventricular Systolic Function', 'MVO', 'left ventricular ejection fraction (LVEF', 'IMH size']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003652', 'cui_str': 'Apyrase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",54.0,0.0676234,"IMH size at 48 hours was significantly greater than that at 24 hours, 72 hours, and 5 days after reperfusion (all p < 0.001).","[{'ForeName': 'Ziqian', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Kunming Medical College, Kunming, China.'}, {'ForeName': 'Ruzhi', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ridong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'APT Therapeutics Inc., St Louis, MO, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Fabao', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China. gaofabao@wchscu.cn.'}]",Korean journal of radiology,['10.3348/kjr.2019.0853']
1143,31211324,Digoxin-mortality: randomized vs. observational comparison in the DIG trial.,"AIMS
The Digitalis Investigation Group (DIG) trial, the only large randomized trial of digoxin in heart failure, reported a neutral effect on mortality and a significant reduction in heart failure hospitalizations. Recent observational studies reported increased mortality with digoxin treatment. We present further analyses of the DIG trial displaying the inability to control bias in observational treatment comparisons despite extensive statistical adjustments.
METHODS AND RESULTS
Forty-four percent of the 6800 patients in the DIG trial had been treated with digoxin before randomization, and half of them were randomly withdrawn from digoxin treatment. We contrast the main randomization-based result of the DIG trial with the observational non-randomized comparison of patients pre-treated or not pre-treated with digoxin. Mortality [hazard ratio (HR) 1.22, 95% confidence interval (CI) 1.12-1.34; P < 0.001] and heart failure hospitalizations (HR 1.47, 95% CI 1.33-1.61; P < 0.001) were significantly higher in patients pre-treated with digoxin even after adjustment for baseline population differences. The higher risks for both outcomes in those who had previously received digoxin persisted even if they received placebo during the trial (HR 1.24, 95% CI 1.10-1.40; P < 0.001). This sharply contradicts the neutral effect on mortality and the significant reduction in heart failure hospitalizations observed in the randomized comparison.
CONCLUSION
Prescription of digoxin is an indicator of disease severity and worse prognosis, which cannot be fully accounted for by covariate adjustments in the DIG trial where patients were well-characterized. It is unlikely that weaker research approaches (observational studies of administrative data or registries) can provide more reliable estimates of the effects of cardiac glycosides.",2019,"The higher risks for both outcomes in those who had previously received digoxin persisted even if they received placebo during the trial (HR 1.24, 95% CI 1.10-1.40; P < 0.001).","['Forty-four percent of the 6800 patients in the DIG trial had been treated with digoxin before randomization, and half of them were randomly withdrawn from digoxin treatment']","['digoxin', 'placebo']","['Mortality [hazard ratio (HR', 'Digoxin-mortality', 'heart failure hospitalizations']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3181833', 'cui_str': 'Dig(dhd)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",6800.0,0.436592,"The higher risks for both outcomes in those who had previously received digoxin persisted even if they received placebo during the trial (HR 1.24, 95% CI 1.10-1.40; P < 0.001).","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Aguirre Dávila', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Bavendiek', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': 'Statistics Collaborative, Inc., Washington, DC, USA.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover, Germany.'}]",European heart journal,['10.1093/eurheartj/ehz395']
1144,31206607,Prospective randomized trial comparing two doses of rabbit anti-thymocyte globulin in patients with severe aplastic anaemia.,"The treatment of choice for patients with severe aplastic anaemia (SAA) includes immunosuppressive therapy (IST) with anti-thymocyte globulin (ATG) and ciclosporin A. However, the optimal dose for rabbit ATG has yet to be established. We herein report the first prospective, randomized, multicentre study comparing two doses of rabbit ATG in patients with SAA. Patients with SAA who required initial IST in Japan (n = 89), China (n = 85) and Korea (n = 48) were enrolled between May 2012 and October 2017. A 1:1 block randomization was employed for two doses of rabbit ATG. In total, 222 patients were randomized, with 112 patients receiving 2·5 mg/kg and 110 receiving 3·5 mg/kg of rabbit ATG for 5 days. The primary endpoint was the haematological response at day 180. After 6 months, no significant difference in response rates was observed between the 2·5 and 3·5 mg/kg groups (49% vs. 48%, P = 0·894). Overall survival at 3 years was similar between the two groups [85% (95% confidence interval [CI], 76%-91%) vs. 91% (95% CI, 82%-96%); P = 0·107]. The current study revealed no significant differences in the efficacy and safety between the 2·5 and 3·5 mg/kg doses of rabbit ATG in patients with SAA. Trial registration: UMIN000011134.",2019,"Overall survival at 3 years was similar between the two groups [85% (95% confidence interval [CI], 76%-91%) vs. 91% (95% CI, 82%-96%); P = 0·107].","['patients with SAA', '222 patients were randomized, with 112 patients receiving 2·5\xa0mg/kg and 110 receiving 3·5', 'Patients with SAA who required initial IST in Japan (n\xa0=\xa089), China (n\xa0=\xa085) and Korea (n\xa0=\xa048) were enrolled between May 2012 and October 2017', 'patients with severe aplastic anaemia (SAA', 'patients with severe aplastic anaemia']","['rabbit anti-thymocyte globulin', 'rabbit ATG', 'rabbit', 'immunosuppressive therapy (IST) with anti-thymocyte globulin (ATG) and ciclosporin A']","['Overall survival', 'response rates', 'efficacy and safety', 'haematological response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}]","[{'cui': 'C3887509', 'cui_str': 'Rabbits'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",222.0,0.251333,"Overall survival at 3 years was similar between the two groups [85% (95% confidence interval [CI], 76%-91%) vs. 91% (95% CI, 82%-96%); P = 0·107].","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Narita', 'Affiliation': 'Department of Paediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Xiaofan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Muramatsu', 'Affiliation': 'Department of Paediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Jingliao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Jun H', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Department of Haematology Oncology, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Kook', 'Affiliation': 'Department of Paediatrics, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Republic of Korea.'}, {'ForeName': 'Hawk', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Haematology, Gachon University Gil Medical Centre, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Usuki', 'Affiliation': 'Department of Haematology, NTT Medical Centre Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Transfusion Medicine, Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Paediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nakao', 'Affiliation': 'Department of Haematology and Respirology, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Jong', 'Initials': 'J', 'LastName': 'Wook Lee', 'Affiliation': ""Department of Haematology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Department of Paediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of haematology,['10.1111/bjh.16055']
1145,31481504,A Phase I Study of the Combination of Rituximab and Ipilimumab in Patients with Relapsed/Refractory B-Cell Lymphoma.,"PURPOSE
Based on the potential for ipilimumab (I) to augment T-cell activation, we hypothesize that ipilimumab would augment the efficacy of rituximab (R) in patients with relapsed/refractory (R/R) CD20 + non-Hodgkin's lymphoma (NHL). This phase I study aimed to identify a recommended phase 2 dose, document toxicities, and preliminarily assess efficacy and potential predictive biomarkers.
PATIENTS AND METHODS
Thirty-three patients with R/R CD20 + B-cell lymphoma received R at 375 mg/m 2 weekly for 4 weeks and I at 3 mg/kg on day 1 and every 3 weeks for four doses. Responding patients went on to maintenance with each agent given every 12 weeks. To facilitate correlative analysis, the expansion phase randomized patients to simultaneous R+I versus R with I delayed 2 weeks.
RESULTS
Toxicity was manageable; no dose-limiting toxicity was observed at the doses studied. When considering the entire cohort, efficacy was modest, with an objective response rate (ORR) of 24% and median progression-free survival (PFS) of 2.6 months. However, in follicular lymphoma patients, the ORR was 58% with a median PFS of 5.6 months. The randomized comparison of R with R+I demonstrated that R+I resulted in more effective B-cell depletion (BCD). Both B-cell depletion and the ratio of CD45RA - regulatory T cell (Treg) to Treg were associated with response at all time points.
CONCLUSIONS
The combination of R+I has manageable toxicity and encouraging efficacy in R/R follicular lymphoma. The ratio of CD45RA - Tregs to total Tregs, and peripheral BCD should be studied further as potential predictors of response.",2019,"Both B cell depletion and the ratio of CD45RA- Treg to Treg were associated with response at all time points.
","['Thirty-three patients with R/R CD20+ B-cell lymphoma received R at 375mg/m 2 weekly for 4 weeks and', 'patients with relapsed/refractory (R/R) CD20+ NHL', 'Patients with Relapsed/Refractory B-Cell Lymphoma']",['Rituximab and Ipilimumab'],"['median progression-free survival (PFS', 'objective response rate (ORR', 'ORR', 'effective B cell depletion (BCD', 'limiting toxicity']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079731', 'cui_str': 'B-Cell Lymphomas'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",33.0,0.0214727,"Both B cell depletion and the ratio of CD45RA- Treg to Treg were associated with response at all time points.
","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Tuscano', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, California. jtuscano@ucdavis.edu.'}, {'ForeName': 'Emanual', 'Initials': 'E', 'LastName': 'Maverakis', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Groshen', 'Affiliation': 'Biostatistics Core, University of Southern California/Norris Cancer Center, Los Angeles, California.'}, {'ForeName': 'Denice', 'Initials': 'D', 'LastName': 'Tsao-Wei', 'Affiliation': 'Biostatistics Core, University of Southern California/Norris Cancer Center, Los Angeles, California.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Luxardi', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Merleev', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Beaven', 'Affiliation': 'University of North Carolina Comprehensive Cancer Center, Chapel Hill, North Carolina.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'DiPersio', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Popplewell', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kirschbaum', 'Affiliation': 'Taiho Oncology, Princeton, New Jersey.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Schroeder', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Newman', 'Affiliation': 'Division of Molecular Pharmacology, Department of Medical Oncology, City of Hope, Duarte, California, USA.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0438']
1146,31070388,The relationship between social norms and sexual risk-reduction intentions and behavior among men who have sex with men: Findings from an eHealth intervention.,"Normative-based research has found that norms are significant predictors of safe sex behavioral intentions and behavior. Research shows that group identity moderates the relationship between norms and intentions/behavior. The present study used the theory of normative social behavior to evaluate whether identification with characters in an HIV-prevention interactive video moderated the relationship between sexual risk-taking norms and risk reduction intentions/behavior. Participants included 540 men between the ages 18 and 30 enrolled in a randomized controlled trial with a 3-month follow-up. We found support for the hypothesized interaction. At low levels of character identification, the negative relationship between sexual risk-taking norms and risk reduction intentions was strong. However, as character identification increased, the link between norms and intentions became weaker. The mean intentions score of high-risk norm participants was elevated to the level reported by low risk norm participants, demonstrating the favorable effect of character identification on narrative persuasion in entertainment-education. The utility of a social norms approach to health behavior change is discussed in the context of eHealth interventions. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"The mean intentions score of high-risk norm participants was elevated to the level reported by low risk norm participants, demonstrating the favorable effect of character identification on narrative persuasion in entertainment-education.","['Participants included 540 men between the ages 18 and 30 enrolled', 'men who have sex with men']",[],['mean intentions score'],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",540.0,0.0176018,"The mean intentions score of high-risk norm participants was elevated to the level reported by low risk norm participants, demonstrating the favorable effect of character identification on narrative persuasion in entertainment-education.","[{'ForeName': 'Anne-Marie B', 'Initials': 'AB', 'LastName': 'Basaran', 'Affiliation': 'Department of Communication.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Christensen', 'Affiliation': 'Department of Communication.'}, {'ForeName': 'Lynn Carol', 'Initials': 'LC', 'LastName': 'Miller', 'Affiliation': 'Annenberg School for Communication and Journalism.'}, {'ForeName': 'Paul Robert', 'Initials': 'PR', 'LastName': 'Appleby', 'Affiliation': 'Annenberg School for Communication & Journalism.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Read', 'Affiliation': 'Department of Psychology.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000467']
1147,31623760,Sex-Specific Thresholds of High-Sensitivity Troponin in Patients With Suspected Acute Coronary Syndrome.,"BACKGROUND
Major disparities between women and men in the diagnosis, management, and outcomes of acute coronary syndrome are well recognized.
OBJECTIVES
The aim of this study was to evaluate the impact of implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds for myocardial infarction in women and men with suspected acute coronary syndrome.
METHODS
Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge, cluster-randomized controlled trial across 10 hospitals. Myocardial injury was defined as high-sensitivity cardiac troponin I concentration >99th centile of 16 ng/l in women and 34 ng/l in men. The primary outcome was recurrent myocardial infarction or cardiovascular death at 1 year.
RESULTS
A total of 48,282 patients (47% women) were included. Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%. Following implementation, women with myocardial injury remained less likely than men to undergo coronary revascularization (15% vs. 34%) and to receive dual antiplatelet (26% vs. 43%), statin (16% vs. 26%), or other preventive therapies (p < 0.001 for all). The primary outcome occurred in 18% (369 of 2,072) and 17% (488 of 2,919) of women with myocardial injury before and after implementation, respectively (adjusted hazard ratio: 1.11; 95% confidence interval: 0.92 to 1.33), compared with 18% (370 of 2,044) and 15% (513 of 3,325) of men (adjusted hazard ratio: 0.85; 95% confidence interval: 0.71 to 1.01).
CONCLUSIONS
Use of sex-specific thresholds identified 5 times more additional women than men with myocardial injury. Despite this increase, women received approximately one-half the number of treatments for coronary artery disease as men, and outcomes were not improved. (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome [High-STEACS]; NCT01852123).",2019,Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%.,"['Patients', 'women', '48,282 patients (47% women) were included', 'women by 42% and in men by 6', '99th centile of 16', 'women and men with suspected acute coronary syndrome', 'Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge, cluster-randomized controlled trial across 10 hospitals']",['implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds'],"['recurrent myocardial infarction or cardiovascular death', 'coronary revascularization', 'myocardial injury', 'high-sensitivity cardiac troponin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]",,0.486415,Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%.,"[{'ForeName': 'Kuan Ken', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Amy V', 'Initials': 'AV', 'LastName': 'Ferry', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Strachan', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Chapman', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Dorien M', 'Initials': 'DM', 'LastName': 'Kimenai', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands; Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Steven J R', 'Initials': 'SJR', 'LastName': 'Meex', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands; Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Findlay', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cruickshank', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Emergency Medicine Research Group Edinburgh, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Collinson', 'Affiliation': ""Departments of Clinical Blood Sciences and Cardiology, St. George's, University Hospitals NHS Trust and St. George's University of London, London, United Kingdom.""}, {'ForeName': 'Fred S', 'Initials': 'FS', 'LastName': 'Apple', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Hennepin County Medical Center & University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'McAllister', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Donogh', 'Initials': 'D', 'LastName': 'Maguire', 'Affiliation': 'Emergency Medicine Department, Glasgow Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Tuck', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Keerie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom. Electronic address: nick.mills@ed.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.082']
1148,31775396,An Anthocyanin-Rich Mixed-Berry Intervention May Improve Insulin Sensitivity in a Randomized Trial of Overweight and Obese Adults.,"Evidence supports the beneficial effects of berries on glucoregulation, possibly related to flavonoid content, fiber content, or both. The purpose of this study was to assess the potential of mixed berries to improve insulin sensitivity and to identify the potential role of flavonoids and fiber. In a randomized cross-over trial with four treatment periods, overweight/obese men and women were fed a controlled 45% fat diet for one week prior to a meal-based glucose tolerance test. The same base diet was provided during each feeding period with the addition of one of four treatments: whole mixed berries, sugar matched mixed berry juice, sugar matched gelatin, and sugar/fiber matched gelatin. Subjects then completed a meal-based oral glucose tolerance test. Serum glucose, insulin and non-esterified fatty acids were not different between individual treatments. However, in a secondary analysis, the combined berry preparations resulted in a lower serum insulin area under the curve (difference of 0.15 ± 0.066 ln pmol min/mL, mean ± SE, p = 0.0228), compared to the combined gelatin treatments, while the difference for serum glucose did not quite meet statistical significance (difference of 0.17 ± 0.093 ln mg·min/dL, mean ± SE, p = 0.0738). These results suggest the potential for mixed berry preparations to improve post-prandial insulin response.",2019,"Serum glucose, insulin and non-esterified fatty acids were not different between individual treatments.","['Overweight and Obese Adults', 'overweight/obese men and women']","['whole mixed berries, sugar matched mixed berry juice, sugar matched gelatin, and sugar/fiber matched gelatin', 'meal-based oral glucose tolerance test', 'Anthocyanin-Rich Mixed-Berry Intervention']","['serum insulin area', 'insulin sensitivity', 'post-prandial insulin response', 'Serum glucose, insulin and non-esterified fatty acids', 'serum glucose', 'Insulin Sensitivity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0005135', 'cui_str': 'Berries'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}]",,0.0180117,"Serum glucose, insulin and non-esterified fatty acids were not different between individual treatments.","[{'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Solverson', 'Affiliation': 'USDA, ARS, Beltsville Human Nutrition Research Center, Beltsville, MD 20705, USA.'}, {'ForeName': 'Theresa R', 'Initials': 'TR', 'LastName': 'Henderson', 'Affiliation': 'USDA, ARS, Beltsville Human Nutrition Research Center, Beltsville, MD 20705, USA.'}, {'ForeName': 'Hawi', 'Initials': 'H', 'LastName': 'Debelo', 'Affiliation': 'Plants for Human Health Institute, North Carolina State University, Kannapolis, NC 28081, USA.'}, {'ForeName': 'Mario G', 'Initials': 'MG', 'LastName': 'Ferruzzi', 'Affiliation': 'Plants for Human Health Institute, North Carolina State University, Kannapolis, NC 28081, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Baer', 'Affiliation': 'USDA, ARS, Beltsville Human Nutrition Research Center, Beltsville, MD 20705, USA.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Novotny', 'Affiliation': 'USDA, ARS, Beltsville Human Nutrition Research Center, Beltsville, MD 20705, USA.'}]",Nutrients,['10.3390/nu11122876']
1149,31201426,The Impact of Learning Multiple Real-World Skills on Cognitive Abilities and Functional Independence in Healthy Older Adults.,"OBJECTIVE
The natural learning experience from infancy to emerging adulthood, when considerable cognitive and functional growth is observed, mandates learning multiple real-world skills simultaneously. The present studies investigated whether learning multiple real-world skills simultaneously is possible in older adults and also whether it improves both their cognitive abilities (working memory, episodic memory, and cognitive control) and functional independence.
METHOD
Over two studies (15 and 27 participants), older adults learned at least three new skills (e.g., Spanish, drawing, music composition) simultaneously for 3 months. Participants completed cognitive and functional assessments before, during, and after the intervention in both studies. Participants were recruited sequentially for an intervention or no-contact control group in Study 1, and Study 2 included only an intervention group, who also completed assessments 4-6 weeks prior to the start of the intervention (i.e., they served as their own control group).
RESULTS
Results from both studies show that simultaneously learning multiple skills is feasible and potentially beneficial for healthy older adults. Learning multiple skills simultaneously increased cognitive abilities in older adults by midpoint of the intervention, to levels similar to performance in a separate sample of middle-aged adults, 30 years younger.
DISCUSSION
Our findings demonstrate the feasibility and potential of conducting a real-world skill-learning intervention involving learning three novel skills with older adults. Our multiskill intervention may provide broad cognitive gains, akin to the benefits experienced earlier in the life span.",2020,"Learning multiple skills simultaneously increased cognitive abilities in older adults by midpoint of the intervention, to levels similar to performance in a separate sample of middle-aged adults.
","['healthy older adults', 'middle-aged adults', 'older adults']","['intervention or no-contact control', 'learning multiple real-world skills', 'real-world skill learning intervention']","['cognitive abilities (working memory, episodic memory, and cognitive control) and functional independence', 'cognitive abilities', 'cognitive abilities and functional independence']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",3.0,0.0257695,"Learning multiple skills simultaneously increased cognitive abilities in older adults by midpoint of the intervention, to levels similar to performance in a separate sample of middle-aged adults.
","[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Leanos', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Kürüm', 'Affiliation': 'Department of Statistics, University of California, Riverside.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Strickland-Hughes', 'Affiliation': 'Department of Psychology, University of the Pacific, Sacramento, California.'}, {'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Ditta', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Gianhu', 'Initials': 'G', 'LastName': 'Nguyen', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Felix', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Hara', 'Initials': 'H', 'LastName': 'Yum', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Bloomberg School of Public Health and Johns Hopkins Center on Aging and Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz084']
1150,31774519,Follow-up of Intervention to Prevent Dental Caries Among Indigenous Children in Australia: A Secondary Analysis of a Randomized Clinical Trial.,"Importance
For an intervention delivered in early childhood to have meaningful translational effect, long-term follow-up is necessary, especially among underserved indigenous children among whom preventable dental disease is common.
Objectives
To test the long-term effectiveness of an early-childhood dental intervention through a follow-up at age 5 years among Aboriginal children in Australia.
Design, Setting, and Participants
This secondary analysis of a randomized clinical trial followed up on participants of the Baby Teeth Talk Study, a 2-group parallel, outcome assessor-blinded, randomized clinical trial conducted among Aboriginal children in South Australia, Australia. Participants included 448 mother or caregiver-child dyads who were enrolled in the Baby Teeth Talk trial between February 2010 and May 2011 and were randomized in the present trial to the immediate intervention group or the delayed intervention group. Intention-to-treat principles were used for all data analyses to estimate the effect of the intervention on dental caries experience. Data analysis was performed from April 10 to May 27, 2019.
Interventions
The intervention comprised 4 services to participants: (1) dental care to mothers during pregnancy, (2) application of fluoride varnish to children's teeth, (3) anticipatory guidance in the form of oral health educational packages, and (4) motivational interviewing for pregnant mothers and children at ages 6, 12, and 18 months in the immediate intervention group and at ages 24, 30, and 36 months in the delayed intervention group.
Main Outcomes and Measures
The primary outcome was the mean number, in the primary dentition, of decayed, missing, or filled teeth (dmft) at age 5 years. Individual components of the dmft index were examined, as was the prevalence of dmft greater than 0.
Results
Of the 449 Aboriginal mothers and children recruited, 223 (49.7%) were randomized to the immediate intervention group and 225 (50.1%) to the delayed intervention group. The mean dmft at age 5 years was 2.10 (95% CI, 2.04 to 2.16) for children in the immediate intervention group and 2.91 (95% CI, 2.83 to 3.00) for children in the delayed intervention group (adjusted mean difference, -1.02; 95% CI, -1.81 to -0.22). When considering children in nonmetropolitan locations, the differences were stark; the mean dmft was 2.46 (95% CI, 2.38-2.54) for children in the immediate intervention group and 3.65 (95% CI, 3.53 to 3.78) for children in the delayed intervention group, with an adjusted mean difference of -1.52 (95% CI, -2.61 to -0.43). Most of this difference was accounted for by missing teeth, with the mean number of missing teeth of children in the immediate intervention group living in nonmetropolitan locations being 0.29 (95% CI, 0.27 to 0.31) compared with 1.02 (95% CI, 0.96 to 1.07) for their counterparts in the delayed intervention group. A 3-fold difference was observed in the percentage of missing teeth greater than 0 between children in the immediate intervention group and those in the delayed intervention group (10.8 [95% CI, 10.2 to 11.4] vs 31.0 [95% CI, 30.1 to 31.8]).
Conclusions and Relevance
This trial found that a multifaceted initiative to reduce early-childhood caries continued to be efficacious in participating indigenous children aged 5 years, especially those residing in nonmetropolitan locations and with teeth missing because of dental disease.
Trial Registration
anzctr.org.au Identifier: ACTRN12611000111976.",2019,"A 3-fold difference was observed in the percentage of missing teeth greater than 0 between children in the immediate intervention group and those in the delayed intervention group (10.8 [95% CI, 10.2 to 11.4] vs 31.0 [95% CI, 30.1 to 31.8]).
","['participating indigenous children aged 5 years', 'Aboriginal children in South Australia, Australia', '449 Aboriginal mothers and children recruited, 223 (49.7', 'participants of the Baby Teeth Talk Study', 'Participants included 448 mother or caregiver-child dyads who were enrolled in the Baby Teeth Talk trial between February 2010 and May 2011', 'Indigenous Children in Australia', 'Aboriginal children in Australia']","[""4 services to participants: (1) dental care to mothers during pregnancy, (2) application of fluoride varnish to children's teeth, (3) anticipatory guidance in the form of oral health educational packages, and (4) motivational interviewing"", 'early-childhood dental intervention', 'multifaceted initiative', 'delayed intervention group', 'immediate intervention group or the delayed intervention group']","['mean number, in the primary dentition, of decayed, missing, or filled teeth (dmft', 'percentage of missing teeth', 'Dental Caries']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0150134', 'cui_str': 'Anticipatory guidance'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0029162'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0399066', 'cui_str': 'Pack filling'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}]",448.0,0.131019,"A 3-fold difference was observed in the percentage of missing teeth greater than 0 between children in the immediate intervention group and those in the delayed intervention group (10.8 [95% CI, 10.2 to 11.4] vs 31.0 [95% CI, 30.1 to 31.8]).
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jamieson', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Smithers', 'Affiliation': 'School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hedges', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mills', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Kapellas', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Diep', 'Initials': 'D', 'LastName': 'Ha', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Loc', 'Initials': 'L', 'LastName': 'Do', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Xiangqun', 'Initials': 'X', 'LastName': 'Ju', 'Affiliation': 'Australian Research Centre for Population Oral Health, Adelaide Dental School, University of Adelaide, Adelaide, South Australia, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.15611']
1151,31774522,Efficacy and Safety of Gemcitabine With Trastuzumab and Pertuzumab After Prior Pertuzumab-Based Therapy Among Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: A Phase 2 Clinical Trial.,"Importance
Taxanes with trastuzumab and pertuzumab for initial treatment of human epidermal growth factor receptor 2 (ERBB2, formerly HER2)-positive metastatic breast cancer is associated with improved progression-free survival (PFS) and overall survival. While continued use of trastuzumab in therapeutic combinations after disease progression is standard, the efficacy of continuing pertuzumab is unknown.
Objective
To evaluate the efficacy and safety of pertuzumab in combination with gemcitabine and trastuzumab after prior treatment with pertuzumab for ERBB2-positive metastatic breast cancer.
Design, Setting, and Participants
This is a phase 2 single-arm clinical trial of dual anti-ERBB2 therapy after prior treatment with pertuzumab. The study took place at a single academic center from March 2015 to April 2017 among women with ERBB2-positive metastatic breast cancer, prior pertuzumab-based treatment, and 3 or fewer prior chemotherapy regimens. Data were analyzed between January 2019 and March 2019.
Intervention
Treatment consisted of gemcitabine, 1200 mg/m2 (later amended to 1000 mg/m2) on days 1 and 8 every 3 weeks, plus trastuzumab (8-mg/kg loading dose, then 6 mg/kg) and pertuzumab (840-mg loading dose, then 420 mg) once every 3 weeks.
Main Outcomes and Measures
The primary end point was 3-month PFS. Based on prior trials, a target rate of 70% or higher was selected as the promising progression-free rate at 3 months. Secondary outcomes included safety, tolerability, and overall survival.
Results
A total of 45 patients (median [range] age, 57.1 [31.7-77.2] years) were enrolled; 22 (49%) were treated in the second-line setting, and 23 (51%) were treated in the third-line setting or beyond. Of these, 22 (49%) received prior trastuzumab emtansine (T-DM1). At a median (range) follow-up of 27.6 (8.3-36.0) months, 3-month PFS was 73.3% (95% CI, 61.5%-87.5%). Overall, median PFS was 5.5 months (95% CI, 5.4-8.2 months). Treatment was well tolerated, with no occurrences of febrile neutropenia or symptomatic left ventricular systolic dysfunction.
Conclusions and Relevance
In this phase 2 trial, treatment with gemcitabine, trastuzumab, and pertuzumab after prior pertuzumab-based therapy for ERBB2-positive metastatic breast cancer was associated with a 3-month PFS rate of 73.3% and was well tolerated. Continuation of pertuzumab beyond progression was associated with apparent clinical benefit.
Trial Registration
ClinicalTrials.gov identifier: NCT02252887.",2019,"Overall, median PFS was 5.5 months (95% CI, 5.4-8.2 months).","['Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer', 'ERBB2-positive metastatic breast cancer', 'single academic center from March 2015 to April 2017 among women with ERBB2-positive metastatic breast cancer, prior pertuzumab-based treatment, and 3 or fewer prior chemotherapy regimens', 'A total of 45 patients (median [range] age, 57.1 [31.7-77.2] years) were enrolled; 22 (49%) were treated in the second-line setting, and 23 (51%) were treated in the third-line setting or beyond']","['pertuzumab', 'gemcitabine and trastuzumab', 'gemcitabine, trastuzumab, and pertuzumab after prior pertuzumab-based therapy', 'gemcitabine', 'trastuzumab emtansine (T-DM1', 'dual anti-ERBB2 therapy', 'trastuzumab', 'Pertuzumab-Based Therapy', 'Taxanes with trastuzumab and pertuzumab', 'Gemcitabine With Trastuzumab and Pertuzumab']","['tolerated', 'safety, tolerability, and overall survival', 'efficacy and safety', 'progression-free survival (PFS) and overall survival', 'Overall, median PFS', 'Efficacy and Safety', 'febrile neutropenia or symptomatic left ventricular systolic dysfunction', 'PFS rate', '3-month PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708784', 'cui_str': '31.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1277187', 'cui_str': 'Left ventricular systolic dysfunction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0414862,"Overall, median PFS was 5.5 months (95% CI, 5.4-8.2 months).","[{'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Iyengar', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Lillian M', 'Initials': 'LM', 'LastName': 'Smyth', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lake', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Gucalp', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jasmeet C', 'Initials': 'JC', 'LastName': 'Singh', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Traina', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'DeFusco', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Monica N', 'Initials': 'MN', 'LastName': 'Fornier', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Goldfarb', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Jhaveri', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Shanu', 'Initials': 'S', 'LastName': 'Modi', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Troso-Sandoval', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ulaner', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Jochelson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Norton', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Chau T', 'Initials': 'CT', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.16211']
1152,31782930,Cardiorespiratory fitness and muscular endurance responses immediately and 2 months after a whole-body Tabata or vigorous-intensity continuous training intervention.,"Young adults (52 females, 16 males; age = 21 ± 3 years; V̇ O 2peak : 41 ± 6 mL/(kg·min)) were randomized into 3 groups: ( i ) no-exercise control (CTL; n = 15), ( ii ) Tabata ( n = 27), or ( iii ) vigorous-intensity continuous training (VICT; n = 26) groups for a 4-week supervised training period (4 sessions/week). V̇ O 2peak , time-to-fatigue (TTF), 5 km time-trial performance (TT), and muscular endurance were assessed at baseline, post-training (POST), and 2-month follow-up (FU). Response confidence intervals (CI) were used to classify individuals as likely responders (R; CI > 0). Both exercise interventions increased TTF and TT at POST (both p < 0.01), but these benefits were maintained at FU after VICT only ( p < 0.01). Push-up performance was increased at POST and FU (both p < 0.01) after Tabata. VICT resulted in a greater proportion of TTF R versus both groups at POST (CTL: 1/15; VICT: 19/26; Tabata: 9/27) and versus Tabata at FU (3/15; 13/26; 4/27). VICT also had a greater proportion of TT R versus CTL at POST (2/15; 17/26; 10/27). Tabata had a greater proportion of R for maximum push-up repetitions versus both groups at POST (3/15; 6/26; 18/27) and versus CTL at FU (2/15; 10/26; 18/27). Collectively, VICT appears to be more effective for improving cardiorespiratory fitness, whereas whole-body Tabata confers larger improvements in push-up performance following short-term training. Novelty: Vigorous-intensity continuous training elicits larger improvements in cardiorespiratory fitness versus whole-body Tabata. Individual response profiles parallel group-level changes in cardiorespiratory fitness and muscular endurance.",2020,Push-up performance was increased at POST and FU (both p<0.01) after Tabata.,"['Young adults (n=68 [52 F]; age=21±3 y; VO2peak: 41±6 mL/kg/min', 'n=15), Tabata (n=26), or']","['vigorous-intensity continuous training (VICT; n=27) group for a four-week supervised training period', 'VICT', 'whole-body Tabata or vigorous-intensity continuous training intervention', 'no-exercise control (CTL']","['Cardiorespiratory fitness and muscular endurance responses', 'proportion of TTF R', 'cardiorespiratory fitness and muscular endurance', 'Response confidence intervals (CI', 'cardiorespiratory fitness', 'VO2peak, time-to-fatigue (TTF), 5 km time-trial performance (TT), and muscular endurance', 'TTF and TT at POST', 'Novelty bullets']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}]",,0.0254434,Push-up performance was increased at POST and FU (both p<0.01) after Tabata.,"[{'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Islam', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Siemens', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Jennifer B L', 'Initials': 'JBL', 'LastName': 'Matusiak', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sawula', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Bonafiglia', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Preobrazenski', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Jung', 'Affiliation': 'School of Health and Exercise Sciences, The University of British Columbia Okanagan, 1147 Research Road, Kelowna, BC V1V 1V7, Canada.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Gurd', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0492']
1153,31782931,Blood flow restriction impairs the inflammatory adaptations of strength training in overweight men: a clinical randomized trial.,"The aim of this study was to evaluate the impact of high-intensity strength training (ST) or low-intensity strength training with blood flow restriction (ST-BFR) on monocyte subsets, the expression of C-C chemokine receptor 5 (CCR5), and CD16 on monocytes, and tumor necrosis factor alpha (TNF-α) production of overweight men. Thirty overweight men were randomly assigned to conventional ST or ST-BFR. Both groups performed exercises of knee extension and biceps curl with equal volume (3 sessions/week) over 8 weeks, and the peripheral frequency of monocytes (CD14+CD16-, classical monocytes; CD14+CD16+, intermediate monocytes; CD14-CD16+, nonclassical monocytes), the mean fluorescence intensity (MFI) of CCR5 and CD16 on CD14+ monocytes; and the production of TNF-α by lipopolysaccharide (LPS)-stimulated cells were quantified. Eight weeks of ST increased the frequency of CD14+CD16- monocytes ( p = 0.04) and reduced the percentage of CD14-CD16+ ( p = 0.02) and the production of TNF-α by LPS-stimulated cells ( p = 0.03). The MFI of CD16 on CD14+ monocytes decreased after the ST intervention ( p = 0.02). No difference in monocyte subsets, CCR5 or CD16 expression, and TNF-α production were identified after ST-BFR intervention ( p > 0.05). The adoption of ST promotes anti-inflammatory effects on monocyte subsets of overweight men, but this effect was lost when BFR was adopted. Novelty High-intensity strength training reduces the production of TNF-α and the peripheral frequency of CD16+ monocytes in overweight men. Blood flow restriction method blunts the strength training adaptations on monocyte subsets and pro-inflammatory TNF-α production in overweight men.",2020,"No difference in monocyte subsets, CCR5 or CD16 expression and TNF-α production were identified after ST-BFR intervention (p>0.05).","['overweight men', '30 overweight men']","['strength training', 'Blood flow restriction', 'high-intensity strength training (ST) or low-intensity strength training with blood flow restriction (ST-BFR', 'conventional ST or ST-BFR', 'High intensity strength training', 'ST']","['monocyte subsets, the expression of C-C Chemokine Receptor 5 (CCR5) and CD16 on monocytes, and tumor necrosis factor-alpha (TNF-α) production', 'mean fluorescence intensity (MFI) of CCR5 and CD16 on CD14+ monocytes; and the production of TNF-α by lipopolysaccharide (LPS)-stimulated cells', 'monocyte subsets and pro-inflammatory TNF-α production', 'frequency of CD14+CD16- monocytes', 'monocyte subsets, CCR5 or CD16 expression and TNF-α production', 'production of TNF-α and the peripheral frequency of CD16+ monocytes', 'MFI of CD16 on CD14+ monocytes', 'percentage of CD14-CD16', 'Novelty •']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0282552', 'cui_str': 'C-C Chemokines'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0033268'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",30.0,0.0117553,"No difference in monocyte subsets, CCR5 or CD16 expression and TNF-α production were identified after ST-BFR intervention (p>0.05).","[{'ForeName': 'Igor Martins', 'Initials': 'IM', 'LastName': 'da Silva', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}, {'ForeName': 'Maeli Andressa', 'Initials': 'MA', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}, {'ForeName': 'Simone Lunelli', 'Initials': 'SL', 'LastName': 'Galvão', 'Affiliation': 'Research Center. Methodist University Center IPA. Porto Alegre, RS 90420-060, Brazil.'}, {'ForeName': 'Gilson P', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Motricity Sciences, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP 19060-90, Brazil.'}, {'ForeName': 'Pedro R T', 'Initials': 'PRT', 'LastName': 'Romão', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': 'Laboratory of Cellular and Molecular Immunology, Department of Health Basic Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS 90050-170, Brazil.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0700']
1154,31782661,Effects of a person-centred telephone support on fatigue in people with chronic heart failure: Subgroup analysis of a randomised controlled trial.,"INTRODUCTION
Fatigue is a prevalent symptom that is associated with various conditions. In patients with chronic heart failure (CHF), fatigue is one of the most commonly reported and distressing symptoms and it is associated with disease progression. Person-centred care (PCC) is a fruitful approach to increase the patient's ability to handle their illness.
AIM
The aim of this study was to evaluate the effects of PCC in the form of structured telephone support on self-reported fatigue in patients with CHF.
METHOD
This study reports a subgroup analysis of a secondary outcome measure from the Care4Ourselves randomised intervention. Patients ( n =77) that were at least 50 years old who had been hospitalized due to worsening CHF received either usual care ( n =38) or usual care and PCC in the form of structured telephone support ( n =39). Participants in the intervention group created a health plan in partnership with a registered nurse. The plan was followed up and evaluated by telephone. Self-reported fatigue was assessed using the Multidimensional Fatigue Inventory 20 (MFI-20) at baseline and at 6 months. Linear regression was used to analyse the change in MFI-20 score between the groups.
RESULTS
The intervention group improved significantly from baseline to the 6-month follow-up compared with the control group regarding the 'reduced motivation' dimension of the MFI-20 (Δ -1.41 versus 0.38, p =0.046).
CONCLUSION
PCC in the form of structured telephone support shows promise in supporting patients with CHF in their rehabilitation, improve health-related quality of life and reduce adverse events.
TRIAL REGISTRATION
ISRCTN.com ISRCTN55562827.",2020,"The intervention group improved significantly from baseline to the 6-month follow-up compared with the control group regarding the 'reduced motivation' dimension of the MFI-20 (Δ -1.41 versus 0.38, p =0.046).
","['Patients ( n =77) that were at least 50 years old who had been hospitalized due to worsening CHF received either usual care ( n =38) or', 'patients with CHF', 'patients with chronic heart failure (CHF', 'people with chronic heart failure']","['health plan in partnership with a registered nurse', 'person-centred telephone support', 'usual care and PCC in the form of structured telephone support', 'Person-centred care (PCC', 'PCC']","['Self-reported fatigue', ""motivation' dimension of the MFI-20"", 'Multidimensional Fatigue Inventory 20 (MFI-20', 'MFI-20 score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse (occupation)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.103449,"The intervention group improved significantly from baseline to the 6-month follow-up compared with the control group regarding the 'reduced motivation' dimension of the MFI-20 (Δ -1.41 versus 0.38, p =0.046).
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallström', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lilas', 'Initials': 'L', 'LastName': 'Ali', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Ekman', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119891599']
1155,31173551,Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial.,"PURPOSE
In the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier: NCT01847274), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy.
PATIENTS AND METHODS
A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (g BRCA mut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed g BRCA mut (non-g BRCA mut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to g BRCA mut status and response to their last platinum-based therapy. Ovarian cancer-specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy-Ovarian Symptom Index.
RESULTS
Progression-free survival was improved in patients treated with niraparib compared with placebo in both the g BRCA mut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non-g BRCA mut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.
CONCLUSION
Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.",2019,"No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.
","['patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy', 'patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy', 'Patients With Recurrent Ovarian Cancer', '203 patients with a germline BRCA mutation (g BRCA mut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed g BRCA mut (non-g BRCA mut), 173 had a PR and 177 had a CR', 'A total of 553 patients were enrolled in the trial']","['Niraparib Maintenance Therapy', 'Last Platinum-Based Chemotherapy', 'placebo']","['incidence of any-grade and grade 3 or greater adverse events', 'Ovarian cancer-specific symptoms and quality of life', 'Progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",553.0,0.0700869,"No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.
","[{'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Del Campo', 'Affiliation': ""Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Vall d'Hebrón University Hospital, Barcelona, Spain.""}, {'ForeName': 'Ursula A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Malander', 'Affiliation': 'Nordic Society of Gynaecological Oncology (NSGO) and Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Provencher', 'Affiliation': ""Centre Hospitalier de L'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and University Hospital, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Follana', 'Affiliation': ""Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Centre Antoine Lacassagne, Nice, France.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Waters', 'Affiliation': 'National Cancer Research Institute (NCRI) and Kent Oncology Centre, Maidstone Hospital, Kent, United Kingdom.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Berek', 'Affiliation': ""Stanford Women's Cancer Center, Stanford Cancer Institute, Stanford, CA.""}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Woie', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Canzler', 'Affiliation': 'AGO and Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Gil-Martin', 'Affiliation': ""GEICO and Institut Català d'Oncologia-IDIBELL, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lesoin', 'Affiliation': 'GINECO and Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St Joseph's Hospital, Phoenix, AZ.""}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': 'NSGO and Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Gilbert', 'Affiliation': 'McGill University, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Benigno', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'TESARO: A GSK Company, Waltham, MA.'}, {'ForeName': 'Sebastien J', 'Initials': 'SJ', 'LastName': 'Hazard', 'Affiliation': 'TESARO: A GSK Company, Waltham, MA.'}, {'ForeName': 'Mansoor R', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'NSGO and Rigshospitalet-Copenhagen University Hospital, Copenhagen, Denmark.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02238']
1156,31221354,Atrial Remodeling Following Catheter Ablation for Atrial Fibrillation-Mediated Cardiomyopathy: Long-Term Follow-Up of CAMERA-MRI Study.,"OBJECTIVES
This study sought to determine the long-term right atrial (RA) electrical and structural changes in a subgroup from the CAMERA-MRI (Catheter Ablation Versus Medical Rate Control in Atrial Fibrillation and Systolic Dysfunction-Magnetic Resonance Imaging) study.
BACKGROUND
Catheter ablation (CA) is successful in restoring ventricular function in patients with atrial fibrillation (AF) and otherwise unexplained cardiomyopathy, as demonstrated in the randomized study of CA versus rate control (CAMERA-MRI). It is unknown if this is associated with atrial remodeling.
METHODS
Detailed electroanatomical (EA) mapping of the RA using CARTO3 and a force sensing catheter was performed at initial CA and electively at least 12 months after CA in patients with >90% reduction in AF burden following ablation. Bipolar voltage, fractionation, and conduction velocity were collected in 4 segments together with echo and cardiac magnetic resonance imaging.
RESULTS
Fifteen patients (mean age 59.1 ± 6.8 years) underwent repeat RA EA mapping. At a mean follow-up of 23.4 ± 11.9 months, left ventricular (LV) ejection fraction improved from 33.6 ± 3.2% to 54.1 ± 3.2% (p = 0.001), RA area decreased from 28.4 ± 2.0 cm 2 to 20.8 ± 1.2 cm 2 (p < 0.001), and left atrial area decreased from 32.9 ± 2.3 cm 2 to 26.8 ± 1.4 cm 2 (p = 0.007). On EA mapping, RA bipolar voltage increased from 1.6 ± 0.1 mV to 1.9 ± 0.1 mV (p = 0.04). Tissue voltage increased across all regions, which achieved statistical significance at the posterior (p = 0.002) and septal (p = 0.01) segments. There was a significant decrease in complex fractionated electrograms from 21.7 ± 3.5% to 8.3 ± 1.8% (p = 0.002); however, no significant change occurred in global or regional conduction velocities (p = 0.5).
CONCLUSIONS
Recovery of atrial electrical and structural changes was observed following restoration of sinus rhythm and recovery of LV function in patients who underwent CA for persistent AF and LV systolic dysfunction. The randomized CAMERA MRI study demonstrated significant improvement in LV systolic function with AF ablation compared with rate control. The present study demonstrated reverse electrical and structural atrial recovery in concert with recovery of LV systolic function at 2 years post-AF ablation. This may partially explain the long-term success of CA in patients with AF and otherwise unexplained cardiomyopathy.",2019,"Tissue voltage increased across all regions, which achieved statistical significance at the posterior (p = 0.002) and septal (p = 0.01) segments.","['Fifteen patients (mean age 59.1 ± 6.8 years) underwent repeat RA EA mapping', 'patients with atrial fibrillation (AF) and otherwise unexplained cardiomyopathy', 'Cardiomyopathy', 'patients with AF and otherwise unexplained cardiomyopathy']","['Catheter Ablation', 'CAMERA-MRI (Catheter Ablation Versus Medical Rate Control', 'AF ablation', 'Catheter ablation (CA']","['Tissue voltage', 'left ventricular (LV) ejection fraction', 'left atrial area', 'RA bipolar voltage', 'LV systolic function', 'complex fractionated electrograms', 'Bipolar voltage, fractionation, and conduction velocity', 'RA area', 'global or regional conduction velocities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}]","[{'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.0320368,"Tissue voltage increased across all regions, which achieved statistical significance at the posterior (p = 0.002) and septal (p = 0.01) segments.","[{'ForeName': 'Hariharan', 'Initials': 'H', 'LastName': 'Sugumar', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Prabhu', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Voskoboinik', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Gutman', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Geoffrey R', 'Initials': 'GR', 'LastName': 'Wong', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Parameswaran', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chrishan J', 'Initials': 'CJ', 'LastName': 'Nalliah', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'McLellan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Taylor', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Liang-Han', 'Initials': 'LH', 'LastName': 'Ling', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Kalman', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Kistler', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia. Electronic address: peter.kistler@baker.edu.au.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.03.009']
1157,31219919,One Size Does Not Fit All: A Perspective on the American Society of Anesthesiologists Physical Status Classification for Pediatric Patients.,"BACKGROUND
The American Society of Anesthesiologists physical status (ASA-PS) classification system is used worldwide to classify patients based on comorbid conditions before general anesthesia. Despite its popularity, the ASA-PS classification system has been shown to have poor interrater reliability due to its subjective definitions, especially when applied to the pediatric population. We hypothesized that the clarification of ASA-PS definitions to better reflect pediatric conditions would improve the accuracy of ASA-PS applied to this population.
METHODS
A stratified, randomized sample of 120 pediatric surgical cases was collected from a tertiary-care pediatric hospital. A team of senior anesthesiologists reclassified ASA-PS within this patient sample using the suggested pediatric-specific ASA-PS definitions. Interrater reliability was measured using intraclass correlation (ICC) and Fleiss κ statistic. In addition, a qualitative study component using small focus groups of senior anesthesiologists identified areas of ambiguity within the ASA-PS system.
RESULTS
Among the 90 reclassifications within each ASA-PS group, 42.2% (n = 38) of ASA-PS I were upgraded to ASA-PS II, and 36.7% (n = 33) of ASA-PS II were upgraded to ASA-PS III. In addition, 28.9% (n = 26) of ASA-PS III were upgraded to ASA-PS IV, and 24.4% (n = 22) of ASA-PS IV were downgraded to III. ICC across the reclassified ASA-PS categories was 0.77 (95% confidence interval [CI], 0.71-0.83; P < .001) demonstrating strong overall agreement. Fleiss κ statistic was lowest in ASA-PS II and III patients (κ = 0.41 and κ = 0.30, respectively) indicating lower agreement beyond chance within these subgroups. Focus groups revealed common themes such as active sequelae of disease, active versus well-controlled presence of comorbidities, and the possible inclusion of functional limitations as important considerations.
CONCLUSIONS
The ASA-PS classification system has several benefits including ease-of-use, simplicity, and flexibility. However, revising the ASA-PS system to provide better guidance for pediatric patients could be valuable. While this study demonstrates good interrater reliability with the included ASA-PS pediatric definitions, further work is needed to clarify accurate assignment of ASA-PS within the midrange of the scale (ASA-PS II and III) and explore its implementation in other institutions.",2020,"Fleiss κ statistic was lowest in ASA-PS II and III patients (κ = 0.41 and κ = 0.30, respectively) indicating lower agreement beyond chance within these subgroups.","['senior anesthesiologists identified areas of ambiguity within the ASA-PS system', '120 pediatric surgical cases was collected from a tertiary-care pediatric hospital', 'pediatric patients', 'American Society of Anesthesiologists Physical Status Classification for Pediatric Patients']",['ASA-PS'],"['Interrater reliability', 'Fleiss κ statistic']","[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0647347', 'cui_str': 'ASA-PS'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450990', 'cui_str': 'American Society of Anesthesiologists physical status classification'}]","[{'cui': 'C0647347', 'cui_str': 'ASA-PS'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",120.0,0.0557776,"Fleiss κ statistic was lowest in ASA-PS II and III patients (κ = 0.41 and κ = 0.30, respectively) indicating lower agreement beyond chance within these subgroups.","[{'ForeName': 'Lynne R', 'Initials': 'LR', 'LastName': 'Ferrari', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Leahy', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Staffa', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Charis', 'Initials': 'C', 'LastName': 'Crofton', 'Affiliation': ""Complex Care Service, Division of General Pediatrics, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Methot', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Berry', 'Affiliation': ""Complex Care Service, Division of General Pediatrics, Boston Children's Hospital, Boston, Massachusetts.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004277']
1158,31219033,The Postopera tive Quality of Life in Children and Adolescents with Craniopharyngioma.,"BACKGROUND
Craniopharyngioma is a tumor of low histological malignancy resulting from an anomaly of embryonic development. Affected children and adolescents are being studied with respect to their quality of life, progression-free survival, and overall survival in the framework of the ongoing KRANIOPHARYNGEOM 2007 project.
METHODS
This prospective, multicenter project consists of a randomized trial with an adaptive design combined with a purely observational study. The randomized, unblinded trial includes patients whose tumors have been incompletely resected and is intended to compare the outcomes of immediate postoperative radiotherapy versus radiotherapy on progression. Its primary endpoint is quality of life as assessed subjectively by the patients them- selves with the ""Pediatric Quality of Life"" questionnaire (PEDQOL). In exploratory analyses, linear mixed models were used to study the effect of further factors on quality of life.
RESULTS
An interim intention-to-treat analysis of the randomized trial revealed only minor differences between the treatment arms with respect to quality of life (n = 24). The exploratory analyses (n = 131) showed that preoperative involvement of, or operative damage to, the anterior and posterior regions of the hypothalamus was associated with a lower quality of life. Complete resection was followed by a lower quality of life than incomplete resection. Radiotherapy, a common treatment for tumors that progress after incomplete resection, was also associated with a lower quality of life.
CONCLUSION
Hypothalamus-sparing treatment approaches are recommended to optimize the quality of life of children and adolescents with cranio- pharyngioma. The available evidence does not support any recommendation as to when radiotherapy should be performed after incomplete resection so that the best quality of life can be achieved.",2019,"Affected children and adolescents are being studied with respect to their quality of life, progression-free survival, and overall survival in the framework of the ongoing KRANIOPHARYNGEOM 2007 project.
","['Children and Adolescents with Craniopharyngioma', 'children and adolescents with cranio- pharyngioma']","['Radiotherapy', 'radiotherapy versus radiotherapy']","['Postopera tive Quality of Life', 'quality of life, progression-free survival, and overall survival', 'quality of life as assessed subjectively by the patients them- selves with the ""Pediatric Quality of Life"" questionnaire (PEDQOL', 'quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010276', 'cui_str': ""Rathke's Cleft Neoplasm""}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0512248,"Affected children and adolescents are being studied with respect to their quality of life, progression-free survival, and overall survival in the framework of the ongoing KRANIOPHARYNGEOM 2007 project.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Eveslage', 'Affiliation': ""Institute of Biostatistics and Clinical Research, Universtity of Münster; Department of Pediatric Hematology/Oncology, University Children's Hospital Bonn; Department of Interventional and Diagnostic Neuroradiology, Universitiy Hospital Würzburg; Department of Radiation Oncology, University of Leipzig; Department of Radiotherapy, University Hospital Regensburg; Department of Particle Therapy, University Hospital Essen, West German Proton Therapy Centre Essen (WPE); Division of Pediatric Neurosurgery within the Department of Neurosurgery, University Hospital Tübingen; Department of Neurosurgery, University Medical Center Hamburg-Eppendorf (UKE); Institute of Biostatistics and Clinical Research, Universtity of Münster; Department of General Pediatrics, Hematology/Oncology, University Children's Hospital Oldenburg.""}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Calaminus', 'Affiliation': ''}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Warmuth-Metz', 'Affiliation': ''}, {'ForeName': 'Rolf-Dieter', 'Initials': 'RD', 'LastName': 'Kortmann', 'Affiliation': ''}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Pohl', 'Affiliation': ''}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Timmermann', 'Affiliation': ''}, {'ForeName': 'Martin Ulrich', 'Initials': 'MU', 'LastName': 'Schuhmann', 'Affiliation': ''}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Flitsch', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Faldum', 'Affiliation': ''}, {'ForeName': 'Hermann Lothar', 'Initials': 'HL', 'LastName': 'Müller', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0321']
1159,31761447,Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study.,"The safety and efficacy of neuronavigated intermittent theta burst stimulation (iTBS) in patients with bipolar depression has not yet been investigated. We hypothesized the superiority of active iTBS over sham. Twenty-six patients were randomly allocated to receive either active (n=12) or sham (n=14) iTBS. Response and remission rates according to changes in depression MADRS score were high following active iTBS (72% and 42% for response and remission rates, respectively), but no significant difference was found after sham stimulation (42%and 25%). No adverse events were observed. This study revealed the safety and tolerability of twice daily iTBS in patients with bipolar depression. Larger controlled studies are warranted to prove iTBS superiority in treatment-resistant bipolar depression.",2019,"Response and remission rates according to changes in depression MADRS score were high following active iTBS (72% and 42% for response and remission rates, respectively), but no significant difference was found after sham stimulation (42%and 25%).","['patients with bipolar depression', 'Twenty-six patients', 'bipolar depression']","['active (n=12) or sham (n=14) iTBS', 'Twice-daily neuronavigated intermittent theta burst stimulation', 'neuronavigated intermittent theta burst stimulation (iTBS']","['adverse events', 'Response and remission rates', 'depression MADRS score', 'safety and efficacy', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.225988,"Response and remission rates according to changes in depression MADRS score were high following active iTBS (72% and 42% for response and remission rates, respectively), but no significant difference was found after sham stimulation (42%and 25%).","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bulteau', 'Affiliation': 'Clinical Investigation Unit ""Behavioral Addictions/Complex Affective Disorders"", Addictology and Psychiatry Department, CHU de Nantes, 44000 Nantes, France; Inserm U1246, MethodS in Patients-centered outcomes and HEalth Research, University of Nantes, 44000 Nantes, France. Electronic address: samuel.bulteau@chu-nantes.fr.'}, {'ForeName': 'Lysianne', 'Initials': 'L', 'LastName': 'Beynel', 'Affiliation': 'CNRS, UMR5105, Laboratory of Psychology and Neurocognition, Grenoble Alpes University, 38000 Grenoble, France; Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200, Trent Drive, Box 3620 DUMC, NC 27710 Durham, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marendaz', 'Affiliation': 'CNRS, UMR5105, Laboratory of Psychology and Neurocognition, Grenoble Alpes University, 38000 Grenoble, France.'}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': ""Dall'Igna"", 'Affiliation': 'Department of Psychiatry and Neurology, CHU de Grenoble, 38000 Grenoble, France.'}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Peré', 'Affiliation': 'Biostatistic department, CHU de Nantes, 44000 Nantes, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Harquel', 'Affiliation': 'CNRS, UMR5105, Laboratory of Psychology and Neurocognition, Grenoble Alpes University, 38000 Grenoble, France.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Chauvin', 'Affiliation': 'CNRS, UMR5105, Laboratory of Psychology and Neurocognition, Grenoble Alpes University, 38000 Grenoble, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Guyader', 'Affiliation': 'CNRS UMR5216, Grenoble Images Speech Signal and Control, Grenoble Alpes University, 38000 Grenoble, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sauvaget', 'Affiliation': 'Clinical Investigation Unit ""Behavioral Addictions/Complex Affective Disorders"", Addictology and Psychiatry Department, CHU de Nantes, 44000 Nantes, France; Laboratory ""Movement, Interactions, Performance"" (EA 4334), Faculty of Sport Sciences, University of Nantes, Nantes, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Vanelle', 'Affiliation': 'Clinical Investigation Unit ""Behavioral Addictions/Complex Affective Disorders"", Addictology and Psychiatry Department, CHU de Nantes, 44000 Nantes, France.'}, {'ForeName': 'Mircea', 'Initials': 'M', 'LastName': 'Polosan', 'Affiliation': 'Department of Psychiatry and Neurology, CHU de Grenoble, 38000 Grenoble, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Bougerol', 'Affiliation': 'Department of Psychiatry and Neurology, CHU de Grenoble, 38000 Grenoble, France.'}, {'ForeName': 'Jerôme', 'Initials': 'J', 'LastName': 'Brunelin', 'Affiliation': 'Inserm U1028, CNRS UMR5292, Lyon Neuroscience Research Center, PSYR2 Team, University Lyon, 69000 Lyon, France; University Lyon 1, 69000 Villeurbanne, France; Centre hospitalier Le Vinatier, 69678 Bron, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Szekely', 'Affiliation': 'Department of psychiatry, centre hospitalier Princesse-Grace, 98000 Monaco.'}]",Neurophysiologie clinique = Clinical neurophysiology,['10.1016/j.neucli.2019.10.002']
1160,31790279,Impact of resistance training program configuration on the circulating brain-derived neurotrophic factor response.,"This study examined the acute and resting changes of brain-derived neurotrophic factor (BDNF) and inteleukin-6 (IL-6) and if changes in these biomarkers were correlated during resistance training (RT). Fifteen men with ≥2 years of RT experience (age: 23 ± 3 years, body mass: 84.4 ± 12.3 kg) participated. Subjects performed RT 3×/week for 6 weeks in either a high-repetition (HR; n = 8) or low-repetition (LR; n = 7) group. Protocols during week 1 were HR - Monday: 4 (sets) × 12 (repetitions) at 60% of 1-repetition maximum, Wednesday: 4 × 10 at 65%, Friday: 5 × 8 at 70%; LR - Monday: 8 × 6 at 75%, Wednesday 9 × 4 at 80%, Friday: 10 × 2 at 85%. Total volume was equated for the 6 weeks but not for individual sessions. Greater volume and intensity were performed in LR versus HR ( p < 0.01) on Mondays. Plasma was collected immediately before and after exercise of the Monday session. There were no significant interactions or main effects for BDNF ( p > 0.05). There was a moderate between-group effect size (0.57) in favor of LR in week 6, suggesting a potentially greater acute increase in BDNF in LR versus HR. For IL-6, a statistically significant main effect was observed for training ( p < 0.0001), showing an acute increase in IL-6 in both weeks ( p < 0.01); however, no other 3-way or 2-way interactions existed ( p > 0.05). A minimum volume threshold of RT may be needed to induce acute elevations in BDNF. Novelty A minimum RT volume threshold may be needed to elicit BDNF. A close proximity to failure may be needed to elicit BDNF. BDNF and IL-6 did not correlate.",2020,"For IL-6, a statistically significant main effect was observed for training (p<0.0001), showing an acute increase in IL-6 in both weeks (p<0.01), however, no other three-way or two-way interactions existed (p>0.05).","['Fifteen men with ≥2yrs of RT experience (age: 23±3yrs, body mass: 84.4±12.3kg) participated']",['Friday'],"['Circulating Brain-Derived Neurotrophic Factor Response', 'Greater volume and intensity', 'BDNF and IL-6', 'acute increase in IL-6', 'Novelty •', 'Total volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0585029', 'cui_str': 'Friday (qualifier value)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0296483,"For IL-6, a statistically significant main effect was observed for training (p<0.0001), showing an acute increase in IL-6 in both weeks (p<0.01), however, no other three-way or two-way interactions existed (p>0.05).","[{'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Quiles', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Klemp', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Dolan', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Maharaj', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Chun-Jung', 'Initials': 'CJ', 'LastName': 'Huang', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Andy V', 'Initials': 'AV', 'LastName': 'Khamoui', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Trexler', 'Affiliation': 'Stronger By Science, LLC, Raleigh, NC 27604, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Whitehurst', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Zourdos', 'Affiliation': 'Department of Exercise Science and Health Promotion, Muscle Physiology Laboratory, Florida Atlantic University, Boca Raton, FL 33431, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0419']
1161,30474314,Biomechanical changes in the cornea following cataract surgery: A prospective assessment with the Corneal Visualisation Scheimpflug Technology.,"IMPORTANCE
Intraocular pressure (IOP) is often reduced following cataract surgery. Postoperative changes in corneal stiffness are likely to be at least partly responsible for any reduction in IOP measured with applanation tonometry.
BACKGROUND
To determine the effect of cataract surgery and corneal incision size on corneal biomechanics.
DESIGN
Prospective randomized trial.
PARTICIPANTS
One hundred prospectively enrolled patients qualifying for cataract surgery.
METHODS
Participants were randomized to clear corneal incisions with a 2.20 or 2.85 mm keratome. Corneal Visualisation Scheimpflug Technology (Corvis-ST) tonometry and dynamic corneal response measurements were obtained preoperatively, and 3 mo postoperatively. Multiple regression analysis was completed using R software.
MAIN OUTCOME MEASURES
Corvis-ST biomechanical parameters.
RESULTS
Ninety-three eyes of 93 patients were included in the final analysis. Mean Corvis-ST biomechanically corrected IOP decreased by 3.63 mmHg postoperatively (95% confidence interval = 2.97-4.35, P ≤ 0.01), and central pachymetry increased by 6.96 μm (4.33-9.59, P ≤ 0.01). Independent of IOP and pachymetry changes, mean (±SE) corneal first applanation stiffness parameter reduced by 9.761 ± 3.729 (P = 0.01) postoperatively. First applanation velocity increased by 0.007 ± 0.002 ms, second applanation velocity increased by 0.012 ± 0.004 ms (P ≤ 0.01), the first applanation deformation amplitude increased by 0.008 ± 0.002 mm (P ≤ 0.01) and the deflection amplitude at highest concavity increased by 0.030 ± 0.069 (P ≤ 0.01). There were no significant differences between different incision size groups.
CONCLUSIONS AND RELEVANCE
Corneal stiffness is reduced 3 mo following cataract surgery and is associated with falsely low IOP measurements. This finding may be important for glaucoma patients and in particular when assessing the effectivity of minimally invasive glaucoma surgery devices.",2019,"Mean Corvis-ST biomechanically corrected IOP decreased by 3.63 mmHg postoperatively (95% confidence interval = 2.97-4.35, P ≤ 0.01), and central pachymetry increased by 6.96 μm (4.33-9.59, P ≤ 0.01).","['One hundred prospectively enrolled patients qualifying for cataract surgery', 'Ninety-three eyes of 93 patients were included in the final analysis', 'glaucoma patients', 'cornea following cataract surgery', 'Participants were randomized to clear corneal incisions with a 2.20 or 2.85\u2009mm keratome']","['cataract surgery and corneal incision size', 'Corneal Visualisation Scheimpflug Technology ']","['Mean Corvis-ST biomechanically corrected IOP', 'second applanation velocity', 'IOP and pachymetry changes, mean (±SE) corneal first applanation stiffness parameter', 'Corvis-ST) tonometry and dynamic corneal response measurements', 'central pachymetry', 'deflection amplitude at highest concavity', 'Biomechanical changes', 'First applanation velocity', 'first applanation deformation amplitude']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0010031', 'cui_str': 'Cornea'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1827493', 'cui_str': 'Clear corneal incision'}]","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",100.0,0.0635203,"Mean Corvis-ST biomechanically corrected IOP decreased by 3.63 mmHg postoperatively (95% confidence interval = 2.97-4.35, P ≤ 0.01), and central pachymetry increased by 6.96 μm (4.33-9.59, P ≤ 0.01).","[{'ForeName': 'Henry B', 'Initials': 'HB', 'LastName': 'Wallace', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical and Health Sciences, New Zealand National Eye Centre, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Stuti L', 'Initials': 'SL', 'LastName': 'Misra', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical and Health Sciences, New Zealand National Eye Centre, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sunny S', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical and Health Sciences, New Zealand National Eye Centre, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKelvie', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical and Health Sciences, New Zealand National Eye Centre, University of Auckland, Auckland, New Zealand.'}]",Clinical & experimental ophthalmology,['10.1111/ceo.13451']
1162,31129386,"FOLFOX alone or combined with rilotumumab or panitumumab as first-line treatment for patients with advanced gastroesophageal adenocarcinoma (PRODIGE 17-ACCORD 20-MEGA): a randomised, open-label, three-arm phase II trial.","BACKGROUND
Epidermal growth factor receptor (EGFR) and hepatocyte growth factor (HGF)/mesenchymal-epithelial transition (MET) pathways, which promote tumour growth and proliferation, are often deregulated in advanced gastroesophageal adenocarcinomas. We assessed whether adding panitumumab (an EGFR inhibitor) or rilotumumab (a HGF inhibitor) to first-line fluoropyrimidine-based and platinum-based chemotherapy (modified oxaliplatin, leucovorin and fluorouracil [mFOLFOX6]) benefits to patients with advanced gastroesophageal adenocarcinoma.
PATIENTS AND METHODS
This phase II, open-label, randomised, three-arm study enrolled patients ≥18 years, with advanced gastroesophageal adenocarcinoma, Eastern Cooperative Oncology Group performance status 0-1 and no known HER2 overexpression. Patients were randomly assigned (1:1:1) mFOLFOX6 (oxaliplatin 85 mg/m 2 , leucovorin 400 mg/m 2 , 5-fluorouracil 400 mg/m 2 bolus then 2400 mg/m 2 over 46 h) alone or combined with panitumumab (6 mg/kg) or rilotumumab (10 mg/kg) every 2 weeks until limiting toxicity, patient's refusal or disease progression. The primary end-point was the 4-month progression-free survival (PFS) rate. Secondary end-points included overall survival (OS) and tolerance.
RESULTS
The study enrolled 162 patients in 29 French centres. The median follow-up was 23.6 months (interquartile range = 16.4-29.0). The 4-month PFS rate was 71% (95% confidence interval [CI] = 57-82) with chemotherapy alone, 57% (95% CI = 42-71) combined with panitumumab and 61% (95% CI = 47-74) combined with rilotumumab. Median OS was 13.1 months (95% CI = 8.7-16.9) with chemotherapy alone, 8.3 months (95% CI = 6.2-13.2) combined with panitumumab and 11.5 months (95% CI = 7.9-17.1) combined with rilotumumab. Adverse events grade ≥III occurred less frequently with chemotherapy alone (62%) than with panitumumab (83%) and rilotumumab (89%).
CONCLUSIONS
We found no benefit in adding panitumumab or rilotumumab to mFOLFOX6 first-line chemotherapy to treat advanced gastroesophageal adenocarcinoma patients.
TRIAL REGISTRATION
European Clinical Trials Database, number 2009-012797-12.",2019,"Median OS was 13.1 months (95% CI = 8.7-16.9) with chemotherapy alone, 8.3 months (95% CI = 6.2-13.2) combined with panitumumab and 11.5 months (95% CI = 7.9-17.1) combined with rilotumumab.","['162 patients in 29 French centres', 'patients with advanced gastroesophageal adenocarcinoma (PRODIGE 17-ACCORD 20-MEGA', 'patients with advanced gastroesophageal adenocarcinoma', 'advanced gastroesophageal adenocarcinoma patients', 'enrolled patients ≥18 years, with advanced gastroesophageal adenocarcinoma, Eastern Cooperative Oncology Group performance status 0-1 and no known HER2 overexpression']","['FOLFOX alone or combined with rilotumumab or panitumumab', 'panitumumab', 'mFOLFOX6 (oxaliplatin 85\xa0mg/m 2 , leucovorin 400\xa0mg/m 2 , 5-fluorouracil 400', 'mg/m 2 over 46\xa0h) alone or combined with panitumumab', 'panitumumab (an EGFR inhibitor) or rilotumumab (a HGF inhibitor) to first-line fluoropyrimidine-based and platinum-based chemotherapy (modified oxaliplatin, leucovorin and fluorouracil [mFOLFOX6', 'rilotumumab']","['4-month PFS rate', 'Median OS', '4-month progression-free survival (PFS) rate', 'Adverse events grade ≥III', 'overall survival (OS) and tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2743963', 'cui_str': 'rilotumumab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",162.0,0.235601,"Median OS was 13.1 months (95% CI = 8.7-16.9) with chemotherapy alone, 8.3 months (95% CI = 6.2-13.2) combined with panitumumab and 11.5 months (95% CI = 7.9-17.1) combined with rilotumumab.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Malka', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, Université Paris-Saclay, Villejuif, France. Electronic address: david.malka@gustaveroussy.fr.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'François', 'Affiliation': 'Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Penault-Llorca', 'Affiliation': 'Pathology Unit, Centre Jean Perrin, UMR 1240 INSERM IMoST, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Castan', 'Affiliation': ""Biometrics Unit, Institut du Cancer de Montpellier-Val d'Aurelle, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouché', 'Affiliation': 'Department of Hepatogastroenterology and Digestive Oncology, Hôpital Robert Debré, Reims, France.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Bennouna', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest René Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Ghiringhelli', 'Affiliation': 'Department of Medical Oncology, Centre Georges Francois Leclerc, Dijon, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'de la Fouchardière', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Cancer Immunotherapy, INSERM U1098 EFS/BFC, Besançon, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Samalin', 'Affiliation': ""Digestive Oncology Unit, Institut du Cancer de Montpellier-Val d'Aurelle, Montpellier, Université de Montpellier, France.""}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Sorbonne Université, Hôpitaux Universitaires Pitié-Salpétrière, Department of Hepatogastroenterology, APHP, Paris, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Raoul', 'Affiliation': 'Department of Medical Oncology, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Miglianico', 'Affiliation': 'Department of Radiotherapy, Centre Hospitalier Privé Saint Grégoire, Saint Grégoire, France.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Bengrine-Lefèvre', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Dahan', 'Affiliation': 'Department of Digestive Oncology, Centre Hospitalier La Timone, Marseille, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Lecaille', 'Affiliation': 'Department of Hepatogastroenterology, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Aparicio', 'Affiliation': 'Department of Gastroenterology and Digestive Cancerology, Hôpital Avicenne, HUPSSD, Bobigny, Paris 13 University, Sorbonne, Paris Cité, France.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Stanbury', 'Affiliation': 'R&D Unicancer, Paris, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Perrier', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint Joseph, Marseille, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cayre', 'Affiliation': 'Department of Pathology, LBM OncoGenAuvergne, Clermont Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent-Puig', 'Affiliation': 'Université Paris Descartes, Centre de Ressources Biologiques EPIGENETEC, Unité INSERM U775U1147, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': ""Biometrics Unit, Institut du Cancer de Montpellier-Val d'Aurelle, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Emile', 'Affiliation': 'Department of Pathology & EA4340, Hôpital Ambroise Paré & Versailles University, Boulogne Billancourt, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taïeb', 'Affiliation': 'Department of Hepatogastroenterology and Gastrointestinal Oncology, Hôpital Européen Georges Pompidou, Paris, Sorbonne Paris Cité, Paris Descartes University, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.020']
1163,31130429,Stenting for symptomatic vertebral artery stenosis: a preplanned pooled individual patient data analysis.,"BACKGROUND
Symptomatic vertebral artery stenosis is associated with a high risk of recurrent stroke, with higher risks for intracranial than for extracranial stenosis. Vertebral artery stenosis can be treated with stenting with good technical results, but whether it results in improved clinical outcome is uncertain. We aimed to compare vertebral stenting with medical treatment for symptomatic vertebral stenosis.
METHODS
We did a preplanned pooled individual patient data analysis of three completed randomised controlled trials comparing stenting with medical treatment in patients with symptomatic vertebral stenosis. The primary outcome was any fatal or non-fatal stroke. Analyses were performed for vertebral stenosis at any location and separately for extracranial and intracranial stenoses. Data from the intention-to-treat analysis were used for all studies. We estimated hazard ratios (HRs) with 95% CIs using Cox proportional-hazards regression models stratified by trial.
FINDINGS
Data were from 354 individuals from three trials, including 179 patients from VIST (148 with extracranial stenosis and 31 with intracranial stenosis), 115 patients from VAST (96 with extracranial stenosis and 19 with intracranial stenosis), and 60 patients with intracranial stenosis from SAMMPRIS (no patients had extracranial stenosis). Across all trials, 168 participants (46 with intracranial stenosis and 122 with extracranial stenosis) were randomly assigned to medical treatment and 186 to stenting (64 with intracranial stenosis and 122 with extracranial stenosis). In the stenting group, the frequency of periprocedural stroke or death was higher for intracranial stenosis than for extracranial stenosis (ten (16%) of 64 patients vs one (1%) of 121 patients; p<0·0001). During 1036 person-years of follow-up, the hazard ratio (HR) for any stroke in the stenting group compared with the medical treatment group was 0·81% CI 0·45-1·44; p=0·47). For extracranial stenosis alone the HR was 0·63 (95% CI 0·27-1·46) and for intracranial stenosis alone it was 1·06 (0·46-2·42; p interaction =0·395).
INTERPRETATION
Stenting for vertebral stenosis has a much higher risk for intracranial, compared with extracranial, stenosis. This pooled analysis did not show evidence of a benefit for stroke prevention for either treatment. There was no evidence of benefit of stenting for intracranial stenosis. Stenting for extracranial stenosis might be beneficial, but further larger trials are required to determine the treatment effect in this subgroup.
FUNDING
None.",2019,For extracranial stenosis alone the HR was 0·63,"['168 participants (46 with intracranial stenosis and 122 with extracranial stenosis', 'patients with symptomatic vertebral stenosis', 'symptomatic vertebral artery stenosis', '354 individuals from three trials, including 179 patients from VIST (148 with extracranial stenosis and 31 with intracranial stenosis), 115 patients from VAST (96 with extracranial stenosis and 19 with intracranial stenosis), and 60 patients with intracranial stenosis from SAMMPRIS (no patients had extracranial stenosis']","['stenting with medical treatment', 'vertebral stenting with medical treatment']","['frequency of periprocedural stroke or death', 'hazard ratio (HR) for any stroke', 'fatal or non-fatal stroke', 'intracranial stenosis alone']","[{'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0265103', 'cui_str': 'Vertebral Artery Stenosis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",,0.0851326,For extracranial stenosis alone the HR was 0·63,"[{'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Markus', 'Affiliation': 'Stroke Research Group, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK. Electronic address: hsm32@medschl.cam.ac.uk.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Harshfield', 'Affiliation': 'Stroke Research Group, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Compter', 'Affiliation': 'Department of Neurology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Kuker', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'L Jaap', 'Initials': 'LJ', 'LastName': 'Kappelle', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clifton', 'Affiliation': ""Department of Neuroradiology, St George's Hospital, London, UK.""}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rothwell', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Algra', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center, Utrecht University, Utrecht, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30149-8']
1164,31779922,"MRAs in Elderly HF Patients: Individual Patient-Data Meta-Analysis of RALES, EMPAHSIS-HF, and TOPCAT.","OBJECTIVES
This study sought to assess the effect of MRA treatment (vs. placebo) in older patients (≥75 years of age) compared with younger patients (<75 years of age) with heart failure (HF).
BACKGROUND
Mineralocorticoid receptor antagonists (MRAs) have been shown to reduce morbidity and mortality in patients with HF with reduced ejection fraction (HFrEF) and in a subset of patients with HF with preserved EF (HFpEF). Notwithstanding, MRAs are underused, especially in the elderly. Pooling the individual patient data (IPD) provided more statistical power with which to assess the efficacy and safety of MRA treatment in this subpopulation.
METHODS
An IPD meta-analysis was performed using Cox proportional hazards models stratified by trial. A total of 1,756 patients (853 randomized to placebo and 903 to MRA) ≥75 years of age, along with 4,411 patients (2,242 randomized to placebo and 2,169 to MRA) <75 years of age were included. The primary outcome was a composite of death from cardiovascular causes or hospitalization for HF.
RESULTS
The treatment groups were well balanced. Patients ≥75 years of age or older and those 80 years of age, 61% were male, 30% had diabetes, and the mean estimated glomerular filtration rate 59 ml/min. The primary outcome occurred in 331 patients (38.8%) in the placebo group versus 281 (31.1%) in the MRA group (hazard ratio: 0.74; 95% confidence interval: 0.63 to 0.86; p < 0.001; and the heterogeneity p value [heterogeneity p = Cochran's Q p value of treatment effect by study interaction] was 0.52). Cardiovascular death and all-cause death were also reduced by MRAs without significant between-trial or age (younger vs. older) heterogeneity. Worsening renal function and hyperkalemia occurred more frequently in patients taking MRAs (vs. placebo). Compared to younger patients, worsening renal function (but not hyperkalemia) was found more frequently in the elderly.
CONCLUSIONS
MRAs reduced morbidity and mortality in elderly patients with HF, a beneficial effect that is more marked in patients with HFrEF but homogenous across HFrEF and HFpEF. Implementation of measures that increase MRA treatment in this population are warranted.",2019,Cardiovascular death and all-cause death were also reduced by MRAs without significant between-trial or age (younger vs. older) heterogeneity.,"['and 2,169 to MRA)\xa0<75 years of age were included', 'patients with HF with reduced ejection fraction (HFrEF) and in a subset of patients with HF with preserved EF (HFpEF', 'older patients (≥75 years of age) compared with younger patients (<75 years of age) with heart failure (HF', 'elderly patients with HF', 'Patients\xa0≥75 years of age or older and those 80 years of age, 61% were male, 30% had diabetes, and the mean estimated glomerular filtration rate 59\xa0ml/min', 'and 903 to MRA)\xa0≥75 years of age, along with 4,411 patients (2,242 randomized to', 'Elderly HF Patients', '1,756 patients (853 randomized to']","['MRA treatment (vs. placebo', 'placebo', 'MRA', 'Mineralocorticoid receptor antagonists (MRAs']","['composite of death from cardiovascular causes or hospitalization for HF', 'Worsening renal function and hyperkalemia', 'efficacy and safety', 'Cardiovascular death and all-cause death', 'worsening renal function', 'morbidity and mortality']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",853.0,0.200384,Cardiovascular death and all-cause death were also reduced by MRAs without significant between-trial or age (younger vs. older) heterogeneity.,"[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique INSERM 1433, and Cardiovascular and Renal Clinical Trialists, INSERM U1116, CHRU Nancy Brabois, Nancy, France. Electronic address: j.ferreira@chu-nancy.fr.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rossello', 'Affiliation': 'Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain; Department of Cardiology, CIBER de enfermedades Cardio Vasculares, Madrid, Spain.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Eschalier', 'Affiliation': 'Département de Cardiologie, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Cardiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girerd', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique INSERM 1433, and Cardiovascular and Renal Clinical Trialists, INSERM U1116, CHRU Nancy Brabois, Nancy, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique INSERM 1433, and Cardiovascular and Renal Clinical Trialists, INSERM U1116, CHRU Nancy Brabois, Nancy, France.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique INSERM 1433, and Cardiovascular and Renal Clinical Trialists, INSERM U1116, CHRU Nancy Brabois, Nancy, France.""}]",JACC. Heart failure,['10.1016/j.jchf.2019.08.017']
1165,31779923,Influence of Age on Efficacy and Safety of Spironolactone in Heart Failure.,"OBJECTIVES
The authors examined efficacy and safety of spironolactone by age in the Americas region (N = 1,767) of the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial.
BACKGROUND
Heart failure with preserved ejection fraction disproportionately affects older adults who may exhibit changes in physiology and variable pharmacokinetics.
METHODS
TOPCAT enrolled patients with heart failure and a left ventricular ejection fraction ≥45% who were age 50 or older with an estimated glomerular filtration rate ≥30 mL/min/1.73 m 2 and prior heart failure hospitalization or elevated natriuretic peptide levels. Participants were randomized to spironolactone or placebo with a mean follow-up duration of 3.3 years. We assessed treatment effect and safety by protocol-defined age categories (<65, 65 to 74, and ≥75 years).
RESULTS
The mean age was 72 ± 10 years (range 50 to 97 years) with 41% over the age of 75 years. Participants ≥75 years were more commonly women and white and had a lower body mass index and estimated glomerular filtration rate compared with the younger age categories. Spironolactone reduced the primary composite outcome compared with placebo across all age categories (p interaction = 0.42). However, spironolactone was associated with an increased risk of the safety endpoint (hazard ratio: 2.54; 95% confidence interval: 1.91 to 3.37; p < 0.001), particularly in older age groups (p interaction = 0.02). Findings in the whole TOPCAT cohort were consistent with results from the Americas region.
CONCLUSIONS
In this post hoc, exploratory analysis of the TOPCAT trial data from the Americas region, although there was no effect of age on efficacy, there were considerable effects of age on increased rates of adverse safety outcomes. These results should be weighed when considering spironolactone for older heart failure with preserved ejection fraction patients. (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist [TOPCAT]; NCT00094302).",2019,Spironolactone reduced the primary composite outcome compared with placebo across all age categories (p interaction = 0.42).,"['Heart\xa0Failure', 'Americas region (N\xa0=\xa01,767) of the TOPCAT (Treatment of Preserved Cardiac Function Heart\xa0Failure with an', 'older heart failure with preserved ejection fraction patients', 'TOPCAT enrolled patients with heart failure and a left ventricular ejection fraction\xa0≥45% who were age 50 or older with an estimated glomerular filtration rate\xa0≥30', 'The mean age was 72 ± 10 years (range 50 to 97 years) with 41% over the age of 75 years']","['Spironolactone', 'Aldosterone Antagonist', 'placebo', 'spironolactone or placebo', 'Aldosterone Antagonist [TOPCAT', 'spironolactone']","['efficacy and safety', 'glomerular filtration rate', 'risk of the safety endpoint']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3811844'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.113296,Spironolactone reduced the primary composite outcome compared with placebo across all age categories (p interaction = 0.42).,"[{'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Vardeny', 'Affiliation': 'Minneapolis VA Medical Center, Minneapolis, Minnesota; University of Minnesota, Minneapolis, Minnesota. Electronic address: ovardeny@umn.edu.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Beldhuis', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'Institut de Cardiologie de Montreal, Montreal, Quebec, Canada; Université de Montreal, Montreal, Quebec.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Institut de Cardiologie de Montreal, Montreal, Quebec, Canada; Université de Montreal, Montreal, Quebec.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Minneapolis VA Medical Center, Minneapolis, Minnesota; University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Sweitzer', 'Affiliation': 'University of Arizona, Tucson, Arizona.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2019.08.019']
1166,31779925,Heart Failure Prevention in Older Patients Using Intensive Blood Pressure Reduction: Potential Role of Diuretics.,"OBJECTIVES
This study assessed the potential role of differential diuretic drugs in preventing incident acute decompensated heart failure (ADHF) in the SPRINT (Systolic Blood Pressure Intervention Trial) study.
BACKGROUND
SPRINT showed that intensive blood pressure reduction in older patients (50 to 97 years of age) resulted in 36% fewer incident cases of ADHF. However, some investigators have questioned whether this was due merely to intergroup differences in diuretic medications.
METHODS
Detailed use of medication data prospectively collected throughout the trial were examined.
RESULTS
ADHF events occurred in 173 of 9,361 participants. Diuretic medication increased in both arms from screening to baseline visit (from 45% to 50% in the standard arm; and from 43% to 63% in the intensive arm) and then remained steady. The lowest use of diuretic agents was among participants in the standard arm who never had an ADHF event. Withdrawal of diuretic agents at the baseline visit occurred in 6.1% (n = 284) of participants in the standard arm and 2.3% (n = 107) of participants in the intensive arm. Of these, only 11 developed ADHF during the trial (10 in the standard arm, 1 in the intensive arm), and only 1 occurred ≤1 month after diuretic withdrawal. The benefit of ADHF reduction remained significant even after excluding those 11 participants (hazard ratio [HR]: 0.69; 95% confidence interval [CI]: 0.5 to 0.94; p = 0.02). Most ADHF events occurred in participants who were taking prescribed diuretic therapy at the last visit, prior to the ADHF event. There was limited use of loop (<6%) and potassium-sparing diuretic agents (2%). Diuretic use was not a predictor of ADHF (HR: 0.96; 95% CI: 0.66 to 1.40; p = 0.83).
CONCLUSIONS
No evidence was found to suggest that the reduction in new ADHF events in SPRINT was due to differential diuretic use. (Systolic Blood Pressure Intervention Trial [SPRINT]; NCT01206062).",2019,Diuretic medication increased in both arms from screening to baseline visit (from 45% to 50% in the standard arm; and from 43% to 63% in the intensive arm) and then remained steady.,"['older patients (50 to 97 years of age', 'Older Patients Using Intensive Blood Pressure Reduction', 'participants in the standard arm who never had an ADHF event']",['Diuretics'],"['ADHF events', 'new ADHF events', 'Diuretic medication', 'intensive blood pressure reduction', 'ADHF reduction']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",[],"[{'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",11.0,0.0595673,Diuretic medication increased in both arms from screening to baseline visit (from 45% to 50% in the standard arm; and from 43% to 63% in the intensive arm) and then remained steady.,"[{'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Upadhya', 'Affiliation': 'Cardiovascular Medicine Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lovato', 'Affiliation': 'Biostatistics and Data Science, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rocco', 'Affiliation': 'Nephrology Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, Department of Medicine, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Division of Cardiovascular Disease, Department of Medicine, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, Tennessee.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Rodriguez', 'Affiliation': 'Cardiovascular Medicine Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'Cho', 'Affiliation': 'Division of Hypertension and Nephrology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Loretta W', 'Initials': 'LW', 'LastName': 'Cloud', 'Affiliation': 'Biostatistics and Data Science, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Nephrology, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Rosendorff', 'Affiliation': 'Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'James J. Peters Veterans Affairs Medical Center, Bronx, New York. Electronic address: dkitzman@wakehealth.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2019.08.018']
1167,31648845,Patients with pulmonary arterial hypertension with and without cardiovascular risk factors: Results from the AMBITION trial.,"BACKGROUND
The purpose of this study was to compare patients with pulmonary arterial hypertension enrolled in the AMBITION trial with (excluded from the primary analysis set [ex-primary analysis set]) and without (primary analysis set) multiple risk factors for left ventricular diastolic dysfunction.
METHODS
Treatment-naive patients with pulmonary arterial hypertension were randomized to once-daily ambrisentan and tadalafil combination therapy, ambrisentan monotherapy, or tadalafil monotherapy. The primary end point was time from randomization to first adjudicated clinical failure event.
RESULTS
Primary analysis set patients (n = 500), compared with ex-primary analysis set patients (n = 105), were younger (mean, 54.4 vs 62.1 years) with greater baseline 6-minute walk distance (median, 363.7 vs 330.5 meters) and fewer comorbidities (e.g., hypertension and diabetes). Treatment effects of initial combination therapy vs pooled monotherapy were directionally the same for both populations, albeit of a lower magnitude for ex-primary analysis set patients. Initial combination therapy reduced the risk of clinical failure compared with pooled monotherapy in primary analysis set patients (hazard ratio, 0.50; 95% confidence interval, 0.35-0.72), whereas the effect was less clear in ex-primary analysis set patients (hazard ratio, 0.70; 95% confidence interval, 0.35-1.37). Overall, primary analysis set patients had fewer clinical failure events (25% vs 33%), higher rates of satisfactory clinical response (34% vs 24%), and lower rates of permanent study drug withdrawal due to adverse events (16% vs 31%) than ex-primary analysis set patients.
CONCLUSIONS
Efficacy of initial combination therapy vs pooled monotherapy was directionally similar for primary analysis set and ex-primary analysis set patients. However, ex-primary analysis set patients (with multiple risk factors for left ventricular diastolic dysfunction) experienced higher rates of clinical failure events and the response to combination therapy vs monotherapy was attenuated. Tolerability was better in primary analysis set than ex-primary analysis set patients.",2019,"Treatment effects of initial combination therapy vs pooled monotherapy were directionally the same for both populations, albeit of a lower magnitude for ex-primary analysis set patients.","['Primary analysis set patients (n\u202f=\u202f500), compared with ex-primary analysis set patients (n\u202f=\u202f105), were younger (mean, 54.4 vs 62.1 years) with greater baseline 6-minute walk distance (median, 363.7 vs 330.5 meters) and fewer comorbidities (e.g., hypertension and diabetes', 'patients with pulmonary arterial hypertension enrolled in the AMBITION trial with (excluded from the primary analysis set [ex-primary analysis set]) and without (primary analysis set) multiple risk factors for left ventricular diastolic dysfunction', 'Treatment-naive patients with pulmonary arterial hypertension', 'Patients with pulmonary arterial hypertension with and without cardiovascular risk factors']","['daily ambrisentan and tadalafil combination therapy, ambrisentan monotherapy, or tadalafil monotherapy', 'initial combination therapy']","['risk of clinical failure', 'adverse events', 'Tolerability', 'time from randomization to first adjudicated clinical failure event', 'satisfactory clinical response', 'clinical failure events']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",500.0,0.224609,"Treatment effects of initial combination therapy vs pooled monotherapy were directionally the same for both populations, albeit of a lower magnitude for ex-primary analysis set patients.","[{'ForeName': 'Vallerie V', 'Initials': 'VV', 'LastName': 'McLaughlin', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan. Electronic address: vmclaugh@med.umich.edu.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Vachiery', 'Affiliation': 'Cliniques Universitaires de Bruxelles-Hôpital Erasme, Brussels, Belgium.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Oudiz', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Cardiology and Cologne Cardiovascular Research Center, Cologne University Heart Center, Cologne, Germany.'}, {'ForeName': 'Nazzareno', 'Initials': 'N', 'LastName': 'Galiè', 'Affiliation': 'University of Bologna, Bologna, Italy.'}, {'ForeName': 'Joan A', 'Initials': 'JA', 'LastName': 'Barberà', 'Affiliation': ""Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain; Biomedical Research Networking Center on Respiratory Diseases, Madrid, Spain.""}, {'ForeName': 'Adaani E', 'Initials': 'AE', 'LastName': 'Frost', 'Affiliation': 'Houston Methodist Institute for Academic Medicine, Houston, Texas.'}, {'ForeName': 'Hossein-Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'Universities of Giessen and Marburg Lung Center, Giessen, Germany.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Peacock', 'Affiliation': 'Scottish Pulmonary Vascular Unit, Regional Heart and Lung Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Simonneau', 'Affiliation': ""Université Paris Sud, Faculté de Médecine, Le Kremlin Bicêtre, France; AP-HP, Centre de Référence de l'Hypertension Pulmonaire Sévère, Département Hospitalo-Universitaire Thorax Innovation (TORINO), Service de Pneumologie, Hôpital de Bicêtre, Le Kremlin Bicêtre, France; UMR_S 999, Inserm, Laboratoire d'Excellence (LabEx) en Recherche sur le Médicament et l'Innovation Thérapeutique (LERMIT), Centre Chirurgical Marie Lannelongue, Le Plessis Robinson, France.""}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Rubin', 'Affiliation': 'University of California at San Diego, La Jolla, California.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Langley', 'Affiliation': 'GlaxoSmithKline, Uxbridge, United Kingdom.'}, {'ForeName': 'Marius M', 'Initials': 'MM', 'LastName': 'Hoeper', 'Affiliation': 'Hannover Medical School, German Centre for Lung Research, Hannover, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2019.09.010']
1168,30940432,Distribution of a photographic atlas did not reduce postoperative care utilization after pediatric circumcision or the indispensability of the pediatric urology clinic nurse.,"BACKGROUND
Surgery in children is increasingly ambulatory, and caregiver responsibilities for postoperative care can produce anxiety. Prior studies have suggested the distribution of a photographic atlas can mitigate caregiver anxiety and reduce clinic phone calls and in-person presentations after pediatric penile surgery.
OBJECTIVE
A pilot study of the ability of a photographic atlas, distributed to caregivers, was aimed to be conducted to reduce postoperative resource utilization.
STUDY DESIGN
Patients undergoing circumcision or revision circumcision were randomized to standard postoperative instructions vs. standard instructions with a photographic atlas representing appropriate penile appearance at successive time points. Electronic records were reviewed for phone calls or in-person presentations to the clinic or emergency department (ED) within 1 month of surgery.
RESULTS
Fourteen patients (44%) received the atlas, and 18 (56%) did not. Patients who received the atlas did not differ significantly from patients who did not receive it in their rate of clinic phone calls (36% vs 39%, p = 0.85), calls per patient (0.5 vs. 0.7, p = 0.78), ED visits (7% vs. 11%, p = 0.70), calls and visits combined (44% vs. 43%, p = 0.93), or the proportion of calls and emergency room presentations related to concerns about the penile appearance (22% vs. 36%, p = 0.66). Overall, 19 postoperative phone calls were received from 12 patients, and 4 visits to the ED were made by 3 patients. Reasons for calls to the clinic were diverse, and 9 distinct categories of concern were identified apart from wound appearance.
DISCUSSION
The impressive diversity of caregiver concerns prompting postoperative communication may partly underlie the failure of the atlas to reduce resource utilization in this study. Most postoperative calls or visits were unrelated to concern about the penile appearance, which limits the degree to which this or any visual guide to wound healing can reduce the need for postoperative attention.
CONCLUSION
Receipt of the atlas did not significantly reduce postoperative contacts or affect the proportion of contacts represented by concerns about penile appearance. Resources must remain directed toward individualized attention to caregiver concerns, delivered by experienced urologic support staffs, who remain the mainstay of postoperative support.",2019,"Patients who received the atlas did not differ significantly from patients who did not receive it in their rate of clinic phone calls (36% vs 39%,","['Patients undergoing circumcision or revision circumcision', 'Electronic records were reviewed for phone calls or in-person presentations to the clinic or emergency department (ED) within 1 month of surgery']",['standard postoperative instructions vs. standard instructions with a photographic atlas representing appropriate penile appearance at successive time points'],"['rate of clinic phone calls', 'proportion of calls and emergency room presentations related to concerns about the penile appearance', 'postoperative care utilization', 'ED visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0004171', 'cui_str': 'Atlases'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.0332193,"Patients who received the atlas did not differ significantly from patients who did not receive it in their rate of clinic phone calls (36% vs 39%,","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Danzig', 'Affiliation': 'Division of Urology, Department of Surgery, University of Colorado Anschutz Medical Campus, 12631 East 17th Ave., M/S C-319, Aurora, CO, 80045, USA.'}, {'ForeName': 'Trevor T', 'Initials': 'TT', 'LastName': 'Wild', 'Affiliation': 'Division of Urology, Department of Surgery, University of Colorado Anschutz Medical Campus, 12631 East 17th Ave., M/S C-319, Aurora, CO, 80045, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Holbrook', 'Affiliation': ""Department of Urology, Children's Hospital Colorado, 13123 E 16th Ave., Box 463, Aurora, CO, 80045, USA.""}, {'ForeName': 'Duncan T', 'Initials': 'DT', 'LastName': 'Wilcox', 'Affiliation': ""Department of Urology, Children's Hospital Colorado, 13123 E 16th Ave., Box 463, Aurora, CO, 80045, USA. Electronic address: Duncan.wilcox@childrenscolorado.org.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2019.02.016']
1169,31208927,The influence of music therapy on mental well-being among postoperative patients of total knee arthroplasty (TKA).,"OBJECTIVE
The objective of this study was to investigate whether music therapy affects immediate postoperative well-being among patients who had undergone TKA surgery in the recovery unit.
METHOD
A randomized controlled trial was conducted recruiting patients from Hospital Melaka, Malaysia. Postoperative TKA patients with good hearing and visual acuity, fully conscious and prescribed with patients controlled analgesia (PCA) were randomized to either intervention or control groups using a sealed envelope. Patients in the intervention group received usual care with additional music therapy during recovery, while patients in the control group received the usual care provided by the hospital. Two factors identified affecting mental well-being were the pain (measured using numerical rating scale) and anxiety (measured using a visual analog scale) at five different minutes' points (0, 10, 20, 30, and 60).
RESULTS
A total of 56 (control: 28, intervention: 28) postoperative TKA patients consented in the study. There was no difference in baseline characteristics between the two groups (p>0.05). Using Mann-Whitney U tests, patients in music therapy group showed significantly lower numerical pain score at 60min (p=0.045) whereas there was no significant difference between the two groups at all time points for anxiety scores (p>0.05). In the intervention group, Friedman tests showed that there was a significant difference in numerical pain (χ 2 =36.957, df=4, p<0.001) and anxiety score across times (χ 2 =18.545, p=0.001).
CONCLUSIONS
This study found that pain score decreases over time among patients in the music therapy group while no effect is seen for anxiety. It is suggested that music therapy could not affect postoperative TKA patients' mental well-being. Nonetheless, patients reported better pain score despite the small sample.",2019,This study found that pain score decreases over time among patients in the music therapy group while no effect is seen for anxiety.,"['patients from Hospital Melaka, Malaysia', 'Postoperative TKA patients with good hearing and visual acuity, fully conscious and prescribed with patients controlled analgesia (PCA', 'patients who had undergone TKA surgery in the recovery unit', 'A total of 56 (control: 28, intervention: 28) postoperative TKA patients consented in the study', 'postoperative patients of total knee arthroplasty (TKA']","['music therapy', 'usual care provided by the hospital', 'usual care with additional music therapy']","['numerical pain score', 'anxiety score', 'numerical pain', 'anxiety scores', 'pain score', 'pain (measured using numerical rating scale) and anxiety (measured using a visual analog scale', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0424523', 'cui_str': 'Fully conscious (finding)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4075638', 'cui_str': 'Recovery unit (physical object)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",,0.160657,This study found that pain score decreases over time among patients in the music therapy group while no effect is seen for anxiety.,"[{'ForeName': 'Aishairma', 'Initials': 'A', 'LastName': 'Aris', 'Affiliation': 'Department of Nursing, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia. Electronic address: aishairma@ukm.edu.my.'}, {'ForeName': 'Suliza', 'Initials': 'S', 'LastName': 'Sulaiman', 'Affiliation': 'Institut Latihan Kementerian Kesihatan Malaysia (ILKKM), Melaka, Malaysia.'}, {'ForeName': 'Muhammad Kamil', 'Initials': 'MK', 'LastName': 'Che Hasan', 'Affiliation': 'Kulliyyah of Nursing, International Islamic University Malaysia, Pahang, Malaysia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.04.004']
1170,30640244,A comparison of the analgesic efficacy of local infiltration analgesia vs. intrathecal morphine after total knee replacement: A randomised controlled trial.,"BACKGROUND
Local infiltration analgesia (LIA) is an effective pain management technique following total knee arthroplasty (TKA).
OBJECTIVE
To investigate if LIA provides better analgesia for patients undergoing unilateral TKA than intrathecal morphine.
DESIGN
Randomised controlled trial.
SETTING
Single tertiary referral centre.
PATIENTS
Consecutive American Society of Anesthesiologists Physical Status I to III patients scheduled to undergo unilateral TKA were randomised to two groups.
INTERVENTION
The control group received spinal anaesthesia with intrathecal bupivacaine and preservative-free morphine 0.3 mg. The intervention group received opioid-free spinal anaesthesia with bupivacaine, followed by intra-operative infiltration of the knee with levobupivacaine 2 mg kg and adrenaline 0.5 mg diluted to a volume of 100 ml with 0.9% saline. An intra-articular catheter was placed during surgery and used to give a bolus of 15 ml of levobupivacaine 0.5% on the morning of the first postoperative day.
MAIN OUTCOME MEASURES
Visual analogue scale (VAS) scores for pain were assessed repeatedly for 48 h postoperatively, at rest and on passive knee flexion to 30°. The primary outcome was VAS scores for pain at rest and on movement at 24 postoperative hours. Secondary outcomes were VAS scores at rest and on movement at 2, 6, 12 and 48 postoperative hours, opioid consumption, degree of active flexion of operative knee achieved in the first 48 h and the incidence of opioid-related side effects.
RESULTS
Forty three patients completed the study. Mean (± SD) VAS scores for pain at 24 h were lower in the intervention group than the control group at rest; 16.43 (± 20.3) vs. 37.2 (± 33.6), (P = 0.029). VAS scores for pain at 24 h on movement were also lower in the intervention group vs. the control group; 39.1 (± 22.8) vs. 57.0 (± 30.9), (P = 0.037). VAS scores were also lower on movement; 25.9 (± 16.8) vs. 40.5 (± 24.0), (P = 0.028) at 48 h.
CONCLUSION
We conclude that LIA conferred superior analgesia compared with intrathecal morphine 0.3 mg at 24 and 48 h following TKA.
TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT01312415.",2019,"Mean (± SD) VAS scores for pain at 24 h were lower in the intervention group than the control group at rest; 16.43 (± 20.3) vs. 37.2 (± 33.6), (P = 0.029).","['total knee arthroplasty (TKA', 'patients undergoing unilateral TKA than intrathecal morphine', 'Single tertiary referral centre', 'total knee replacement', 'Consecutive American Society of Anesthesiologists Physical Status', 'Forty three patients completed the study', 'III patients scheduled to undergo unilateral TKA']","['LIA', 'levobupivacaine 2\u200amg\u200akg and adrenaline 0.5\u200amg diluted to a volume of 100\u200aml with 0.9% saline', 'opioid-free spinal anaesthesia with bupivacaine', 'intrathecal morphine', 'levobupivacaine', 'local infiltration analgesia vs. intrathecal morphine', 'Local infiltration analgesia (LIA', 'spinal anaesthesia with intrathecal bupivacaine and preservative-free morphine 0.3\u200amg']","['VAS scores at rest and on movement at 2, 6, 12 and 48 postoperative hours, opioid consumption, degree of active flexion of operative knee achieved in the first 48\u200ah and the incidence of opioid-related side effects', 'Visual analogue scale (VAS', 'scores for pain', 'VAS scores', 'VAS scores for pain', 'VAS scores for pain at rest and on movement at 24 postoperative hours', 'Mean (± SD) VAS scores for pain']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.259483,"Mean (± SD) VAS scores for pain at 24 h were lower in the intervention group than the control group at rest; 16.43 (± 20.3) vs. 37.2 (± 33.6), (P = 0.029).","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'From the Department of Anaesthesiology, Cork University Hospital and University College Cork, Cork, Ireland (DM, JM, JG, FL, GS, GI).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McNamara', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Galbraith', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Loughnane', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Shorten', 'Affiliation': ''}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Iohom', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000000943']
1171,31575021,Baseline Serum Vitamin A and D Levels Determine Benefit of Oral Vitamin A&D Supplements to Humoral Immune Responses Following Pediatric Influenza Vaccination.,"Maximizing vaccine efficacy is critical, but previous research has failed to provide a one-size-fits-all solution. Although vitamin A and vitamin D supplementation studies have been designed to improve vaccine efficacy, experimental results have been inconclusive. Information is urgently needed to explain study discrepancies and to provide guidance for the future use of vitamin supplements at the time of vaccination. We conducted a randomized, blinded, placebo-controlled study of influenza virus vaccination and vitamin supplementation among 2 to 8 (inclusive) year old children over three seasons, including 2015-2016 ( n = 9), 2016-2017 ( n = 44), and 2017-2018 ( n = 26). Baseline measurements of vitamins A and D were obtained from all participants. Measurements were of serum retinol, retinol-binding protein (RBP, a surrogate for retinol), and 25-hydroxyvitamin D (25(OH)D). Participants were stratified into two groups based on high and low incoming levels of RBP. Children received two doses of the seasonal influenza virus vaccine on days 0 and 28, either with an oral vitamin supplement (termed A&D; 20,000 IU retinyl palmitate and 2000 IU cholecalciferol) or a matched placebo. Hemagglutination inhibition (HAI) antibody responses were evaluated toward all four components of the influenza virus vaccines on days 0, 28, and 56. Our primary data were from season 2016-2017, as enrollment was highest in this season and all children exhibited homogeneous and negative HAI responses toward the Phuket vaccine at study entry. Responses among children who entered the study with insufficient or deficient levels of RBP and 25(OH)D benefited from the A&D supplement ( p < 0.001 for the day 28 Phuket response), whereas responses among children with replete levels of RBP and 25(OH)D at baseline were unaffected or weakened ( p = 0.02 for the day 28 Phuket response). High baseline RBP levels associated with high HAI titers, particularly for children in the placebo group (baseline RBP correlated positively with Phuket HAI titers on day 28, r = 0.6, p = 0.003). In contrast, high baseline 25(OH)D levels associated with weak HAI titers, particularly for children in the A&D group (baseline 25(OH)D correlated negatively with Phuket HAI titers on day 28, r = -0.5, p = 0.02). Overall, our study demonstrates that vitamin A&D supplementation can improve immune responses to vaccines when children are vitamin A and D-insufficient at baseline. Results provide guidance for the appropriate use of vitamins A and D in future clinical vaccine studies.",2019,"High baseline RBP levels associated with high HAI titers, particularly for children in the placebo group (baseline RBP correlated positively with Phuket HAI titers on day 28, r = 0.6, p = 0.003).","['2 to 8 (inclusive) year old children over three seasons, including 2015-2016 ( n = 9), 2016-2017 ( n = 44), and 2017-2018 ( n = 26', 'Pediatric Influenza Vaccination']","['Oral Vitamin A&D Supplements', 'vitamin A and vitamin D supplementation', 'oral vitamin supplement (termed A&D; 20,000 IU retinyl palmitate and 2000 IU cholecalciferol', 'seasonal influenza virus vaccine', 'placebo', 'influenza virus vaccination and vitamin supplementation', 'vitamin A&D supplementation']","['vaccine efficacy', 'serum retinol, retinol-binding protein (RBP, a surrogate for retinol), and 25-hydroxyvitamin D (25(OH)D', 'High baseline RBP levels', 'Hemagglutination inhibition (HAI) antibody responses', 'HAI titers', 'Phuket HAI titers', 'negative HAI responses']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0681579', 'cui_str': 'Vitamin supplement'}, {'cui': 'C0073115', 'cui_str': 'retinyl palmitate'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4316910', 'cui_str': 'Influenzavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1533658', 'cui_str': 'Vitamin supplement therapy'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C1446172', 'cui_str': 'Retinol binding protein measurement (procedure)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.313418,"High baseline RBP levels associated with high HAI titers, particularly for children in the placebo group (baseline RBP correlated positively with Phuket HAI titers on day 28, r = 0.6, p = 0.003).","[{'ForeName': 'Nehali', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. nehali.patel@stjude.org.""}, {'ForeName': 'Rhiannon R', 'Initials': 'RR', 'LastName': 'Penkert', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. rhiannon.penkert@stjude.org.""}, {'ForeName': 'Bart G', 'Initials': 'BG', 'LastName': 'Jones', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. bart.jones@stjude.org.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sealy', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. bob.sealy@stjude.org.""}, {'ForeName': 'Sherri L', 'Initials': 'SL', 'LastName': 'Surman', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. sherri.surman@stjude.org.""}, {'ForeName': 'Yilun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. yilun.sun@stjude.org.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. li.tang@stjude.org.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'DeBeauchamp', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. jennifer.deBeauchamp@stjude.org.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ashley.webb@stjude.org.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Richardson', 'Affiliation': ""Department of Pharmaceuticals, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. julie.richardson@stjude.org.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Heine', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ryan.heine@stjude.org.""}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Dallas', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ronald.dallas@stjude.org.""}, {'ForeName': 'A Catharine', 'Initials': 'AC', 'LastName': 'Ross', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA 16802, USA. acr6@psu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Webby', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. richard.webby@stjude.org.""}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Hurwitz', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. julia.hurwitz@stjude.org.""}]",Viruses,['10.3390/v11100907']
1172,31188229,Effects of Brimonidine and Timolol on the Progression of Visual Field Defects in Open-angle Glaucoma: A Single-center Randomized Trial.,"PRéCIS:: Instillation of brimonidine or timolol slowed visual field deterioration in patients with open-angle glaucoma; both brimonidine and timolol might improve the mean deviation (MD) slopes.
PURPOSE
The purpose of this study was to investigate and compare the effects of 0.1% brimonidine and 0.5% timolol on the progressing visual field defects in open-angle glaucoma.
PATIENTS AND METHODS
We evaluated 1 eye each of 68 glaucoma patients who were treated with at least 1 prostaglandin analog. Their baseline MD slopes were < -0.5 dB/y based on at least 5 Humphrey field analyzer measurements within 3 years. Eligible eyes were randomly assigned to brimonidine or timolol treatment groups and treatments were administered without the wash-out period. Clinical examinations were performed every 4 months for 2 years. We designated the MD slope as the primary endpoint.
RESULTS
Ultimately, 56 eyes (brimonidine:timolol=26:30) were included in the present study (mean age=65.2 y). Dropout rates of brimonidine and timolol treatment groups were 27.8% and 6.3%, respectively. There were no significant differences in baseline intraocular pressure or MD slopes between brimonidine and timolol groups (12.7 and 12.9 mm Hg, P=0.77, and -1.22 and -1.08 dB/y, P=0.43, respectively). Intraocular pressure decreased significantly in the brimonidine group at 4, 8, 12, and 16 months, and in the timolol group at 4 months, without significant differences between the drugs (P=0.20). MD slopes significantly improved in both groups (brimonidine: -0.38 dB/y, P<0.001; timolol: -0.52 dB/y, P=0.04). Furthermore, there was no significant difference between groups in the primary endpoint (P=0.59).
CONCLUSION
Brimonidine and timolol treatments improved MD slopes in open-angle glaucoma.",2019,MD slopes significantly improved in both groups (brimonidine: -0.38 ,"['Open-angle Glaucoma', '68 glaucoma patients who were treated with at least 1 prostaglandin analog', 'Eligible eyes', 'patients with open-angle glaucoma']","['56 eyes (brimonidine', 'Brimonidine and timolol', 'dB', 'brimonidine', 'brimonidine and timolol', 'timolol', 'Brimonidine and Timolol', 'brimonidine or timolol']","['mean deviation (MD) slopes', 'progressing visual field defects', 'baseline intraocular pressure or MD slopes', 'Progression of Visual Field Defects', 'visual field deterioration', 'Dropout rates', 'baseline MD slopes', 'Intraocular pressure', 'MD slopes']","[{'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin Analogs'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}]","[{'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C3887875', 'cui_str': 'Visual field defect (finding)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}]",,0.0414716,MD slopes significantly improved in both groups (brimonidine: -0.38 ,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Ophthalmology, Tohoku University Hospital.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Public Health, Yamagata University Graduate School of Medical Science, Yamagata.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Ophthalmology, Tohoku University Hospital.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Maekawa', 'Affiliation': 'Departments of Ophthalmology.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Tsuda', 'Affiliation': 'Department of Ophthalmology, Tohoku University Hospital.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Omodaka', 'Affiliation': 'Department of Ophthalmology, Tohoku University Hospital.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Nakazawa', 'Affiliation': 'Departments of Ophthalmology.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001285']
1173,31178639,Comparison of the Effect of Intravenous Tranexamic Acid and Sublingual Misoprostol on Reducing Bleeding After Cesarean Section: A Double-Blind Randomized Clinical Trial.,"Purpose
To evaluate the effects of intravenous tranexamic acid (TA) and sublingual misoprostol on reducing bleeding after cesarean section.
Materials
One hundred and fifty-eight participants with term pregnancies scheduled for cesarean section were randomly divided into two groups. In M group, two sublingual misoprostol pills (400 mg) were administrated, immediately after the delivery. In TA group, ten minutes before skin incision, TA ampoule (1 g) was injected. In both groups, immediately after the delivery, 20 units of oxytocin in 1 L ringer lactate with speed of 1000 CC/h was injected. At the end of the operation, the amount of bleeding was measured based on the number of small and large gauzes, the blood in the suction container and the difference of patient's hemoglobin before and 24 h after surgery.
Results
Hemoglobin level reduction in the TA group was higher than the M group (- 2.45 ± 0.84 vs - 2.14 ± 1.38 g/dL) ( P < 0.001). Furthermore, number of used gauze and blood suction in the TA group was significantly higher compared to sublingual misoprostol (4.67 ± 1.34 vs 3.25 ± 1.31 and 260.25 ± 79.06 vs 193.94 ± 104.79 cc, respectively) ( P < 0.001). Mean blood pressure during the entire duration of surgery in the TA group decreased significantly as compared to the M group ( P < 0.001).
Conclusion
Total bleeding was significantly lower in sublingual misoprostol as compared to the tranexamic acid group. Furthermore, in misoprostol group hemodynamic variables were stabilized greater than tranexamic acid group.
Registration Number
IRCT201708308611N6.",2019,Hemoglobin level reduction in the TA group was higher than the M group (- 2.45 ± 0.84 vs - 2.14 ± 1.38 g/dL),"['After Cesarean Section', 'One hundred and fifty-eight participants with term pregnancies scheduled for cesarean section']","['sublingual misoprostol', 'intravenous tranexamic acid (TA) and sublingual misoprostol', 'tranexamic acid', 'sublingual misoprostol pills', 'misoprostol', 'oxytocin', 'Intravenous Tranexamic Acid and Sublingual Misoprostol']","['Mean blood pressure', 'Bleeding', 'amount of bleeding', 'Hemoglobin level reduction', 'number of used gauze and blood suction', 'Total bleeding']","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy (finding)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C3219623', 'cui_str': 'Misoprostol Pill'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}, {'cui': 'C0005768'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",158.0,0.0386815,Hemoglobin level reduction in the TA group was higher than the M group (- 2.45 ± 0.84 vs - 2.14 ± 1.38 g/dL),"[{'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Pakniat', 'Affiliation': '1Department of Obstetrics and Gynecology, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Chegini', 'Affiliation': '1Department of Obstetrics and Gynecology, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Azarmidokht', 'Initials': 'A', 'LastName': 'Shojaei', 'Affiliation': '2Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Marzieh Beigom', 'Initials': 'MB', 'LastName': 'Khezri', 'Affiliation': '3Department of Anesthesiology, Qazvin University of Medical Sciences, Shahid Bahonar Ave, PO Box 3419759811, Qazvin, Iran.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Ansari', 'Affiliation': '4Shahed University, Tehran, Iran.'}]",Journal of obstetrics and gynaecology of India,['10.1007/s13224-018-1181-x']
1174,31178640,Comparison of Effectiveness of Sublingual and Vaginal Misoprostol for Second-Trimester Abortion.,"Objective
The aim of this study was to compare the efficacy and safety of sublingual and vaginal misoprostol in second-trimester termination of pregnancy in 24 and 48 h.
Study Design
This is a retrospective study of 240 pregnant women seeking termination in second trimester (13-18.5 weeks), in which the patients are subdivided into two groups-first group received 400 mcg of misoprostol sublingually ( n = 120), and second group received 400 mcg of misoprostol vaginally ( n = 120) every 4 h for a maximum of five doses. The course of misoprostol was repeated if the patient did not abort within 24 h.
Results
The mean induction-to-abortion interval was shorter in sublingual group (10.28 ± 3.1 h) versus 14.68 ± 4.2 h in vaginal group in 24 h ( p = 0.0001), and 36.9 ± 4.4 h in sublingual versus 29.7 ± 14 in vaginal group in 48 h ( p = 0.0933). Mean dose requirement for misoprostol by sublingual route was low as compared to vaginal misoprostol (1048 ± 301 mg versus 1250 ± 375 mg; p = 0.0001 in 24 h and 1110 ± 833 mg versus 1325 ± 536 mg; p = 0.0231 in 48 h). No significant difference was found in the success rate (both at 24 and 48 h) and in side effects among the two comparison groups.
Conclusion
Misoprostol as such by any route has been proven as an effective abortifacient in second trimester. Both sublingual and vaginal routes are effective for medical abortion. But shorter induction-to-abortion interval in sublingual route, less dose requirement and higher acceptability makes sublingual route as a better choice.",2019,"No significant difference was found in the success rate (both at 24 and 48 h) and in side effects among the two comparison groups.
","['Second-Trimester Abortion', 'second-trimester termination of pregnancy in 24 and 48\xa0h.\nStudy Design', '240 pregnant women seeking termination in second trimester (13-18.5\xa0weeks']","['vaginal misoprostol', '400\xa0mcg of misoprostol sublingually', '400\xa0mcg of misoprostol', 'Misoprostol', 'misoprostol', 'Sublingual and Vaginal Misoprostol', 'sublingual and vaginal misoprostol']","['mean induction-to-abortion interval', 'side effects', 'success rate', 'efficacy and safety']","[{'cui': 'C0032980', 'cui_str': 'Midtrimester'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",240.0,0.0603979,"No significant difference was found in the success rate (both at 24 and 48 h) and in side effects among the two comparison groups.
","[{'ForeName': 'Alka A', 'Initials': 'AA', 'LastName': 'Mukherjee', 'Affiliation': 'Mukherjee Multispeciality Hospital, Plot 179, Ayurvedic Lay Out, Bhande Plot Square, Umred Road, Nagpur, Maharashtra State India.'}]",Journal of obstetrics and gynaecology of India,['10.1007/s13224-018-1183-8']
1175,31178642,"Can Epidural Dexamethasone Reduce Patient-Controlled Epidural Consumption of Fentanyl and Levobupivacaine in Laboring Women? A Double-Blind, Randomized, Placebo-Controlled Trial.","Background
The efficacy of a single bolus dose of epidural dexamethasone added to levobupivacaine-fentanyl combination for labor analgesia has not been studied. In this randomized double-blind controlled trial, we assessed the effect of epidural dexamethasone in reducing the hourly average consumption of epidural levobupivacaine-fentanyl combination in laboring parturients and to study its effect on pain score, maternal satisfaction, maternal and neonatal outcome.
Methods
Sixty adult ASA I-II single-gestation full-term primigravid laboring parturients with cervical dilation ≤ 5 cm were randomly assigned to two equal-sized groups. Combined spinal-epidural block was performed in all the parturients. After placing the epidural catheter in epidural space, 8 mg of preservative-free dexamethasone was administered to the dexamethasone group, and 0.9% saline to the placebo group. All parturients received continuous background infusion of 5 ml of 0.1% levobupivacaine with 2 μg/ml of fentanyl with the provision of patient-controlled bolus of 5 ml of 0.1% levobupivacaine with 2 μg/ml of fentanyl (lockout interval 15 min). The primary outcome measure was the hourly total consumption of levobupivacaine-fentanyl mixture. The secondary outcome measures were maternal satisfaction, pain score, maternal hemodynamic parameters, fetal heart rate, duration of second stage of labor, mode of delivery, Apgar scores and adverse effects.
Results
Hourly drug consumption and hourly bolus requirement were significantly lower in the dexamethasone group than placebo group (6.97 ml ± 1.22 vs. 8.40 ml ± 2.59 and 0.41 ± 0.26 vs. 0.72 ± 0.55, respectively, P = 0.008 for both). There were no significant differences in other outcome measures.
Conclusion
Epidural dexamethasone significantly decreased average hourly drug consumption and the number of boluses in laboring parturients, thus providing epidural drug dose-sparing effect.",2019,"Results
Hourly drug consumption and hourly bolus requirement were significantly lower in the dexamethasone group than placebo group (6.97 ml ± 1.22 vs. 8.40 ml ± 2.59 and 0.41 ± 0.26 vs. 0.72 ± 0.55, respectively, P = 0.008 for both).","['laboring parturients', 'Laboring Women', 'Methods\n\n\nSixty adult ASA I-II single-gestation full-term primigravid laboring parturients with cervical dilation\u2009≤\u20095\xa0cm']","['epidural dexamethasone', 'Epidural Dexamethasone', 'placebo', 'continuous background infusion of 5\xa0ml of 0.1% levobupivacaine', 'Placebo', 'levobupivacaine', 'fentanyl', 'levobupivacaine-fentanyl combination', 'preservative-free dexamethasone', 'Fentanyl and Levobupivacaine', 'dexamethasone', 'Epidural dexamethasone']","['pain score, maternal satisfaction, maternal and neonatal outcome', 'average hourly drug consumption', 'maternal satisfaction, pain score, maternal hemodynamic parameters, fetal heart rate, duration of second stage of labor, mode of delivery, Apgar scores and adverse effects', 'hourly total consumption of levobupivacaine-fentanyl mixture', 'Hourly drug consumption and hourly bolus requirement']","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018811', 'cui_str': 'Heart Rate, Fetal'}, {'cui': 'C0474477', 'cui_str': 'Duration of second stage of labor (observable entity)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]",60.0,0.750761,"Results
Hourly drug consumption and hourly bolus requirement were significantly lower in the dexamethasone group than placebo group (6.97 ml ± 1.22 vs. 8.40 ml ± 2.59 and 0.41 ± 0.26 vs. 0.72 ± 0.55, respectively, P = 0.008 for both).","[{'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Dhal', 'Affiliation': '1Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector 32, Chandigarh, 160030 India.'}, {'ForeName': 'Sukanya', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': '1Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector 32, Chandigarh, 160030 India.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Saroa', 'Affiliation': '1Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector 32, Chandigarh, 160030 India.'}, {'ForeName': 'Jasveer', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': '1Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector 32, Chandigarh, 160030 India.'}, {'ForeName': 'Reeti', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': '2Department of Obstetrics and Gynaecology, Government Medical College and Hospital, Chandigarh, India.'}]",Journal of obstetrics and gynaecology of India,['10.1007/s13224-018-1189-2']
1176,30659286,Comparison of peak oxygen consumption response to aquatic and robotic therapy in individuals with chronic motor incomplete spinal cord injury: a randomized controlled trial.,"STUDY DESIGN
Randomized dual center controlled clinical trial.
OBJECTIVE
To determine and compare the cardiorespiratory impact of 3 months of aquatic and robotic therapy for individuals with chronic motor incomplete spinal cord injury (CMISCI).
SETTINGS
Two rehabilitation specialty hospitals.
METHODS
Thirty-one individuals with CMISCI with neurological level between C2-T12 at least 1 year post injury were randomized to either aquatic or robotic treadmill therapy for 36 sessions. Customized sessions lasted 40-45 min at 65-75% heart rate reserve intensity with peak oxygen consumption (peak VO 2 ) measured during arm ergometry at baseline and post intervention. Additional peak robotic treadmill VO 2 assessments were obtained before and after training for participants randomized to robotic intervention.
RESULTS
Peak VO 2 measured with arm ergometry was not significantly different with either aquatic intervention (8.1%, p = 0.14, n = 15) or robotic intervention (-0.7%, p = 0.31, n = 17). Peak VO 2 measured with robotic treadmill ergometry demonstrated a statistical improvement (14.7%, p = 0.03, n = 17, two-tailed t-test) across the robotic intervention. Comparison between the two interventions demonstrated a trend favoring aquatic therapy for improving arm ergometry peak VO 2 (ANOVA, p = 0.063).
CONCLUSIONS
Neither 3-month exercise interventions statistically improved arm cycle ergometry peak VO 2 , our cardiorespiratory surrogate marker, although percent improvement was greater in the aquatic exercise condition. Robotic ergometry peak VO 2 did improve for the robotic intervention, confirming previous work. These results suggest that either intervention may hold utility in improving cardiorespiratory fitness in CMISCI, but peak VO 2 measurement technique appears critical in detecting effects.
SPONSORSHIP
DOD CDMRP SCI Research Program Clinical Trial Award SC090147, FY 2009. This study is registered under ClinicalTrials.gov Identifier: NCT01407354.",2019,"Peak VO 2 measured with robotic treadmill ergometry demonstrated a statistical improvement (14.7%, p = 0.03, n = ","['Two rehabilitation specialty hospitals', 'individuals with chronic motor incomplete spinal cord injury', 'Thirty-one individuals with CMISCI with neurological level between C2-T12 at least 1 year post injury', 'individuals with chronic motor incomplete spinal cord injury (CMISCI']","['aquatic and robotic therapy', 'aquatic or robotic treadmill therapy', 'peak oxygen consumption response to aquatic and robotic therapy', 'Robotic ergometry peak VO 2']","['cardiorespiratory fitness', 'Peak VO 2 measured with arm ergometry', 'cycle ergometry peak VO 2 , our cardiorespiratory surrogate marker', 'Peak VO 2 measured with robotic treadmill ergometry']","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0086589', 'cui_str': 'Surrogate Markers'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]",31.0,0.169249,"Peak VO 2 measured with robotic treadmill ergometry demonstrated a statistical improvement (14.7%, p = 0.03, n = ","[{'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gorman', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA. pgorman@umm.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Scott', 'Affiliation': 'University of Maryland Rehabilitation and Orthopaedic Institute, Baltimore, MD, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'VanHiel', 'Affiliation': 'Shepherd Center, Atlanta, GA, USA.'}, {'ForeName': 'Keith E', 'Initials': 'KE', 'LastName': 'Tansey', 'Affiliation': 'Shepherd Center, Atlanta, GA, USA.'}, {'ForeName': 'W Mark', 'Initials': 'WM', 'LastName': 'Sweatman', 'Affiliation': 'Shepherd Center, Atlanta, GA, USA.'}, {'ForeName': 'Paula Richley', 'Initials': 'PR', 'LastName': 'Geigle', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}]",Spinal cord,['10.1038/s41393-019-0239-7']
1177,31175001,"Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial.","BACKGROUND
Patients with relapsed or refractory FLT3 internal tandem duplication (FLT3-ITD)-positive acute myeloid leukaemia have a poor prognosis, including high frequency of relapse, poorer response to salvage therapy, and shorter overall survival than those with FLT3 wild-type disease. We aimed to assess whether single-agent quizartinib, an oral, highly potent and selective type II FLT3 inhibitor, improves overall survival versus salvage chemotherapy.
METHODS
QuANTUM-R is a randomised, controlled, phase 3 trial done at 152 hospitals and cancer centres in 19 countries. Eligible patients aged 18 years or older with ECOG performance status 0-2 with relapsed or refractory (duration of first composite complete remission ≤6 months) FLT3-ITD acute myeloid leukaemia after standard therapy with or without allogeneic haemopoietic stem-cell transplantation were randomly assigned (2:1; permuted block size of 6; stratified by response to previous therapy and choice of chemotherapy via a phone-based and web-based interactive response system) to quizartinib (60 mg [30 mg lead-in] orally once daily) or investigator's choice of preselected chemotherapy: subcutaneous low-dose cytarabine (subcutaneous injection of cytarabine 20 mg twice daily on days 1-10 of 28-day cycles); intravenous infusions of mitoxantrone (8 mg/m 2 per day), etoposide (100 mg/m 2 per day), and cytarabine (1000 mg/m 2 per day on days 1-5 of up to two 28-day cycles); or intravenous granulocyte colony-stimulating factor (300 μg/m 2 per day or 5 μg/kg per day subcutaneously on days 1-5), fludarabine (intravenous infusion 30 mg/m 2 per day on days 2-6), cytarabine (intravenous infusion 2000 mg/m 2 per day on days 2-6), and idarubicin (intravenous infusion 10 mg/m 2 per day on days 2-4 in up to two 28-day cycles). Patients proceeding to haemopoietic stem-cell transplantation after quizartinib could resume quizartinib after haemopoietic stem-cell transplantation. The primary endpoint was overall survival in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02039726, and follow-up is ongoing.
FINDINGS
Between May 7, 2014, and Sept 13, 2017, 367 patients were enrolled, of whom 245 were randomly allocated to quizartinib and 122 to chemotherapy. Four patients in the quizartinib group and 28 in the chemotherapy group were not treated. Median follow-up was 23·5 months (IQR 15·4-32·3). Overall survival was longer for quizartinib than for chemotherapy (hazard ratio 0·76 [95% CI 0·58-0·98; p=0·02]). Median overall survival was 6·2 months (5·3-7·2) in the quizartinib group and 4·7 months (4·0-5·5) in the chemotherapy group. The most common non-haematological grade 3-5 treatment-emergent adverse events (within ≤30 days of last dose or >30 days if suspected to be a treatment-related event) for quizartinib (241 patients) and chemotherapy (94 patients) were sepsis or septic shock (46 patients [19%] for quizartinib vs 18 [19%] for chemotherapy), pneumonia (29 [12%] vs eight [9%]), and hypokalaemia (28 [12%] vs eight [9%]). The most frequent treatment-related serious adverse events were febrile neutropenia (18 patients [7%]), sepsis or septic shock (11 [5%]), QT prolongation (five [2%]), and nausea (five [2%]) in the quizartinib group, and febrile neutropenia (five [5%]), sepsis or septic shock (four [4%]), pneumonia (two [2%]), and pyrexia (two [2%]) in the chemotherapy group. Grade 3 QT prolongation in the quizartinib group was uncommon (eight [3%] by central reading, ten [4%] by investigator report); no grade 4 events occurred. There were 80 (33%) treatment-emergent deaths in the quizartinib group (31 [13%] of which were due to adverse events) and 16 (17%) in the chemotherapy group (nine [10%] of which were due to adverse events).
INTERPRETATION
Treatment with quizartinib had a survival benefit versus salvage chemotherapy and had a manageable safety profile in patients with rapidly proliferative disease and very poor prognosis. Quizartinib could be considered a new standard of care. Given that there are only a few available treatment options, this study highlights the value of targeting the FLT3-ITD driver mutation with a highly potent and selective FLT3 inhibitor.
FUNDING
Daiichi Sankyo.",2019,Overall survival was longer for quizartinib than for chemotherapy (hazard ratio 0·76 [95% CI 0·58-0·98; p=0·02]).,"['Patients proceeding to haemopoietic stem-cell transplantation after quizartinib could resume quizartinib after haemopoietic stem-cell transplantation', 'Eligible patients aged 18 years or older with ECOG performance status 0-2 with relapsed or refractory (duration of first composite complete remission ≤6 months) FLT3-ITD acute myeloid leukaemia after standard therapy with or without allogeneic haemopoietic stem-cell transplantation', 'relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R', 'Between May 7, 2014, and Sept 13, 2017, 367 patients were enrolled, of whom 245 were randomly allocated to quizartinib and 122 to chemotherapy', '152 hospitals and cancer centres in 19 countries', 'Patients with relapsed or refractory FLT3 internal tandem duplication (FLT3-ITD)-positive acute myeloid leukaemia']","['cytarabine', 'mitoxantrone', 'etoposide', 'Quizartinib versus salvage chemotherapy', 'cytarabine (intravenous infusion 2000 mg/m 2 per day on days 2-6), and idarubicin', 'fludarabine', 'intravenous granulocyte colony-stimulating factor', ""chemotherapy via a phone-based and web-based interactive response system) to quizartinib (60 mg [30 mg lead-in] orally once daily) or investigator's choice of preselected chemotherapy: subcutaneous low-dose cytarabine (subcutaneous injection of cytarabine""]","['pyrexia', 'febrile neutropenia', 'treatment-emergent deaths', 'sepsis or septic shock', 'hypokalaemia', 'nausea', 'Overall survival', 'pneumonia', 'QT prolongation', 'Median overall survival', 'overall survival', 'Grade 3 QT prolongation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",367.0,0.408052,Overall survival was longer for quizartinib than for chemotherapy (hazard ratio 0·76 [95% CI 0·58-0·98; p=0·02]).,"[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: jcortes@mdanderson.org.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Khaled', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinelli', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola FC, Italy.'}, {'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Perl', 'Affiliation': 'Abramson Center of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'The University of Kansas Health System, Kansas City, KS, USA.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Russell', 'Affiliation': 'Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Krämer', 'Affiliation': 'Universität Heidelberg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Dombret', 'Affiliation': 'University Paris Diderot, Paris, France.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hogge', 'Affiliation': 'Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Jonas', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Anskar Yu-Hung', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Mehta', 'Affiliation': 'University Hospitals Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitari I Politècnic La Fe, València, Spain; CIBERONC, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Radsak', 'Affiliation': 'University Medical Center of Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Sica', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli-IRCCS, Istituto di Ematologia Università Cattolica Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Arunachalam', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Holmes', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Namuyinga', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Nanxiang', 'Initials': 'N', 'LastName': 'Ge', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Yver', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Yufen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Daiichi Sankyo, Basking Ridge, NJ, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Levis', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30150-0']
1178,31761120,"Sublingual Immunotherapy for Other Indications: Venom Large Local, Latex, Atopic Dermatitis, and Food.","There is some evidence to support the use of sublingual immunotherapy (SLIT) in food allergy, although its role is unclear. One randomized, double-blind, placebo-controlled trial supports the safe and efficacious use of dust mite SLIT in children with mild to moderate atopic dermatitis, but these data have not been confirmed. Although there are several randomized, double-blind, placebo-controlled trials to support the use of SLIT-LATEX, this product is not available in the United States and extrapolation of these effects to latex extracts is unsubstantiated. There is also insufficient evidence to support the use of SLIT for venom hypersensitivity at this time.",2020,"One randomized, double-blind, placebo-controlled trial supports the safe and efficacious use of dust mite SLIT in children with mild to moderate atopic dermatitis, but these data have not been confirmed.",['children with mild to moderate atopic dermatitis'],"['placebo', 'dust mite SLIT', 'sublingual immunotherapy (SLIT', 'Sublingual Immunotherapy']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0026231', 'cui_str': 'Mites'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}]",[],,0.423734,"One randomized, double-blind, placebo-controlled trial supports the safe and efficacious use of dust mite SLIT in children with mild to moderate atopic dermatitis, but these data have not been confirmed.","[{'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Smith', 'Affiliation': 'Department of Allergy/Immunology, Wilford Hall Ambulatory Surgical Center, 1100 Wilford Hall Loop, JBSA- Lackland, San Antonio, TX 78236, USA. Electronic address: derek.m.smith34.mil@mail.mil.'}, {'ForeName': 'Theodore M', 'Initials': 'TM', 'LastName': 'Freeman', 'Affiliation': 'San Antonio Asthma and Allergy Clinic, 2833 Babcock Road, Suite 304, San Antonio, TX 78229, USA.'}]",Immunology and allergy clinics of North America,['10.1016/j.iac.2019.09.011']
1179,31197697,Comparative Perioperative Outcomes by Esophagectomy Surgical Technique.,"INTRODUCTION
Surgical resection is vital in the curative management of patients with esophageal cancer. However, a myriad of surgical procedures exists based on surgeon preference and training. We report on the perioperative outcomes based on esophagectomy surgical technique.
METHODS
A prospectively managed esophagectomy database was queried for patients undergoing esophagectomy from 1996 and 2016. Basic demographics, tumor characteristics, operative details, and post-operative outcomes were recorded and analyzed by comparison of transhiatal vs Ivor-lewis and minimally invasive (MIE) vs open procedures.
RESULTS
We identified 856 patients who underwent esophagectomy. Neoadjuvant therapy was administered in 543 patients (63.4%). There were 504 (58.8%) open esophagectomies and 302 (35.2%) MIE. There were 13 (1.5%) mortalities and this did not differ among techniques (p = 0.6). While there was no difference in overall complications between MIE and open, complications occurred less frequently in patients undergoing RAIL and MIE IVL compared to other techniques (p = 0.003). Pulmonary complications also occurred less frequently in RAIL and MIE IVL (p < 0.001). Anastomotic leaks were less common in patients who underwent IVL compared to trans-hiatal approaches (p = 0.03). MIE patients were more likely to receive neoadjuvant therapy (p = 0.001), have lower blood loss (p < 0.001), have longer operations (p < 0.001), and higher lymph node harvests (p < 0.001) compared to open patients.
CONCLUSION
Minimally invasive and robotic Ivor Lewis techniques demonstrated substantial benefits in post-operative complications. Oncologic outcomes similarly favor MIE IVL and RAIL.",2020,"MIE patients were more likely to receive neoadjuvant therapy (p = 0.001), have lower blood loss (p < 0.001), have longer operations (p < 0.001), and higher lymph node harvests (p < 0.001) compared to open patients.
","['856 patients who underwent esophagectomy', '543 patients (63.4', 'patients undergoing esophagectomy from 1996 and 2016', 'patients with esophageal cancer']","['Esophagectomy Surgical Technique', 'esophagectomy surgical technique', 'MIE IVL and RAIL', 'Neoadjuvant therapy']","['lower blood loss', 'higher lymph node harvests', 'overall complications', 'Anastomotic leaks', 'Basic demographics, tumor characteristics, operative details, and post-operative outcomes', 'Pulmonary complications']","[{'cui': 'C4517894', 'cui_str': '856 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1705114', 'cui_str': 'Rail'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}]",,0.0418486,"MIE patients were more likely to receive neoadjuvant therapy (p = 0.001), have lower blood loss (p < 0.001), have longer operations (p < 0.001), and higher lymph node harvests (p < 0.001) compared to open patients.
","[{'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Meredith', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA. kensurg@hotmail.com.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Maramara', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Blinn', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Huston', 'Affiliation': 'Gastrointestinal Oncology, Florida State University College Of Medicine/Sarasota Memorial Health Care System, 1950 Arlington Street, Suite 101, Sarasota, FL, 34239, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Shridhar', 'Affiliation': 'Radiation Oncology, University of Central Florida, Orlando, FL, USA.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04269-y']
1180,31189497,Basic life support training: Demonstration versus lecture - A randomised controlled trial.,"INTRODUCTION
Basic life support (BLS) and the use of an automated external defibrillator (AED) improve survival from cardiac arrest. The gold standard for teaching BLS/AED is yet to be identified. The aim of this study was to compare the learning outcome of an instructor-led demonstration with a formal lecture for introducing BLS/AED skills. We hypothesized that a demonstration was superior to a lecture.
METHODS
First year-medical students were randomised to either a demonstration or a lecture using PowerPoint® Presentation for skill introduction during European Resuscitation Council BLS/AED courses. Participants were skill-tested after training and required to perform all skills correctly to pass the test. Finally, all participants were asked to state their preferred teaching method.
RESULTS
Overall, 247 participants were included in the analysis (demonstration group: 124, lecture group: 123). Pass rate was 63% in both groups, p = 1.00. Both groups performed median compression rates within guidelines recommendations, p = 0.09. Mean compression depth was 55 mm (10 mm) in the demonstration group compared with 52 mm (10 mm) in the lecture group, p = 0.05. Median tidal volume was 265 (192, 447) ml and 405 (262, 578) ml, p < 0.001, respectively. The lecture group was 3 s faster at initiating BLS, p < 0.001. In total, 226 (91%) participants preferred demonstration on a manikin for introducing BLS/AED.
CONCLUSION
There was no statistically significant difference in pass rate when comparing a demonstration with a lecture for introducing BLS/AED. The lecture group was slightly faster at initiating BLS. Most participants preferred a demonstration as introduction.",2020,There was no statistically significant difference in pass rate when comparing a demonstration with a lecture for introducing BLS/AED.,"['First year-medical students', '247 participants were included in the analysis (demonstration group: 124, lecture group: 123']","['automated external defibrillator (AED', 'demonstration or a lecture using PowerPoint® Presentation']","['Pass rate', 'Median tidal volume', 'Mean compression depth', 'pass rate', 'median compression rates']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",247.0,0.0774313,There was no statistically significant difference in pass rate when comparing a demonstration with a lecture for introducing BLS/AED.,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark; Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark; Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark.'}, {'ForeName': 'Stinne Eika', 'Initials': 'SE', 'LastName': 'Rasmussen', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark.'}, {'ForeName': 'Mette Amalie', 'Initials': 'MA', 'LastName': 'Nebsbjerg', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark.'}, {'ForeName': 'Kasper G', 'Initials': 'KG', 'LastName': 'Lauridsen', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark; Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Bjørnshave Bomholt', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Krogh', 'Affiliation': 'Department of Anesthesia and Intensive Care, Aarhus University Hospital, Palle Juul-Jensens Blvd. 99, 8200 Aarhus, Denmark; Centre for Health Sciences Education, Aarhus University, Palle Juul-Jensens Blvd. 82, INCUBA Skejby building B, 8200 Aarhus, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Løfgren', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark; Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Blvd. 82, INCUBA Skejby building 2, 8200 Aarhus, Denmark; Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 69, 8200 Aarhus, Denmark. Electronic address: bo.loefgren@clin.au.dk.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.06.008']
1181,30904691,Effect of short-term transcutaneous trigeminal nerve stimulation on EEG activity in drug-resistant epilepsy.,"BACKGROUND
Transcutaneous trigeminal nerve stimulation (TNS) has antiepileptic effects in patients with drug-resistant epilepsy (DRE). However, whether and how TNS is able to modulate the electroencephalogram (EEG) background activity in patients with DRE is still unknown.
OBJECTIVES
To investigate the effect of short-term TNS on EEG background activity in DRE by qualitative and quantitative analyses.
METHODS
Twenty-nine DRE patients participated in the study. Twenty-two were randomly divided into a ""sham-TNS"" or ""real-TNS"" group; seven patients underwent stimulation of the median nerve (MNS) at the wrist. Real-TNS was delivered bilaterally to the infraorbital nerve (trains of 1-20 mA, 120 Hz, cyclic modality for 20 min). The sham-TNS protocol mimicked the real-TNS one but at a zero intensity. For MNS, the same parameters as real-TNS were used. EEG was continuously acquired for 40 min: 10' pre, 20' during and 10' post stimulation. EEG was visually inspected for interictal epileptiform discharge (IEDs) changes and processed by spectral analysis for changes in mean frequency and absolute power of each frequency band.
RESULTS
A significant increase of EEG absolute alpha power was observed during real-TNS compared with the sham-TNS (F 34,680 = 1.748; p = 0.006). Conversely, no significant effects were noticed either for quantitative analysis of other frequency bands or for IEDs detection. MNS proved unable to modulate EEG activity.
CONCLUSIONS
Short-term TNS induces an acute and specific effect on background EEG of DRE by increasing the absolute alpha band power. EEG alpha rhythm enhancement may index a cortical functional inhibition and act as a seizure-preventing mechanism.",2019,"A significant increase of EEG absolute alpha power was observed during real-TNS compared with the sham-TNS (F 34,680 = 1.748; p = 0.006).","['Twenty-nine DRE patients participated in the study', 'Twenty-two', 'drug-resistant epilepsy', 'patients with drug-resistant epilepsy (DRE', 'patients with DRE']","['Transcutaneous trigeminal nerve stimulation (TNS', 'short-term transcutaneous trigeminal nerve stimulation', 'short-term TNS', 'sham-TNS"" or ""real-TNS"" group; seven patients underwent stimulation of the median nerve (MNS', 'TNS']","['interictal epileptiform discharge (IEDs) changes', 'EEG activity', 'electroencephalogram (EEG) background activity', 'EEG absolute alpha power']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C1096063', 'cui_str': 'Refractory Epilepsy'}]","[{'cui': 'C0040996', 'cui_str': 'Cranial Nerve V'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0045733', 'cui_str': 'mansic acid'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",22.0,0.0268046,"A significant increase of EEG absolute alpha power was observed during real-TNS compared with the sham-TNS (F 34,680 = 1.748; p = 0.006).","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ginatempo', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Viale San Pietro 43/b, 07100 Sassari, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fois', 'Affiliation': 'Department of Medical, Surgical and Experimental Sciences, University of Sassari, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'De Carli', 'Affiliation': 'Institute of Bioimaging and Molecular Physiology, National Research Council, Genoa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Todesco', 'Affiliation': 'Neurology Unit, A. Segni Hospital - ASL n. 1, Sassari, Italy.'}, {'ForeName': 'Beniamina', 'Initials': 'B', 'LastName': 'Mercante', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Viale San Pietro 43/b, 07100 Sassari, Italy.'}, {'ForeName': 'GianPietro', 'Initials': 'G', 'LastName': 'Sechi', 'Affiliation': 'Department of Medical, Surgical and Experimental Sciences, University of Sassari, Italy.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Deriu', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Viale San Pietro 43/b, 07100 Sassari, Italy. Electronic address: deriuf@uniss.it.'}]",Journal of the neurological sciences,['10.1016/j.jns.2019.03.004']
1182,32410519,Comparison and evaluation of three techniques for treating auricular pseudocyst.,"Background: Auricular pseudocyst is a benign cystic lesion in cartilages of the auricle. Different methods are currently used to manage this disease. In these methods, simple aspiration combined with pressure dressing, local steroid injection and surgery are the most prevalent therapies. Objective: To find the best clinical path for the treatment of auricular pseudocyst. Methods: Eighty-four subjects were randomly allocated into three equal groups (Group A: simple suction combined with pressure dressing; Group B: suction and local steroid injection; and, Group C: surgery). Two otolaryngologists assessed effective rate, sequelae and degree of satisfaction at three-month follow-up. A visual analog scale was used to determine degree of satisfaction. Results: Group A had the lowest effective rate (54%). Group C was highest in terms of effectiveness (100%) but also in incidence of sequelae (71%). Group B had a slightly lower effective rate (86%) than Group C, but the incidence of sequelae was lowest (42%). Degree of satisfaction was highest (7.0 ± 2.7) for Group B. Conclusion: Local steroid injection should be the first choice for the treatment of auricular pseudocyst because of high satisfaction, favorable effectiveness and few sequelae. Where this method is ineffective, surgery should be used.",2020,"Group B had a slightly lower effective rate (86%) than Group C, but the incidence of sequelae was lowest (42%).",['Eighty-four subjects'],"['simple suction combined with pressure dressing; Group B: suction and local steroid injection', 'Local steroid injection']","['Degree of satisfaction', 'incidence of sequelae', 'lowest effective rate', 'effective rate, sequelae and degree of satisfaction', 'effective rate']","[{'cui': 'C4319623', 'cui_str': '84'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1289828', 'cui_str': 'Pressure dressing'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",84.0,0.0604002,"Group B had a slightly lower effective rate (86%) than Group C, but the incidence of sequelae was lowest (42%).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'The First Faculty of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Qianru', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Benling', 'Initials': 'B', 'LastName': 'Guan', 'Affiliation': 'The First Faculty of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Chengfang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Shudong', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Otolaryngology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1770169']
1183,31182181,Does food insulin index in the context of mixed meals affect postprandial metabolic responses and appetite in obese adolescents with insulin resistance? A randomised cross-over trial.,"The food insulin index (II) is a novel classification to rank foods based on their physiological insulin demand relative to an isoenergetic reference food and may be a valid predictor of postprandial insulin responses and appetite. The present study aimed to compare the postprandial metabolic responses and appetite sensations to two macronutrient- and glycaemic index-matched meals with either high or low II in obese adolescents with insulin resistance (IR). A randomised, single-blind and cross-over trial included fifteen obese adolescents aged 12-18 years with IR. All participants were provided with two different breakfasts: low glycaemic index, low insulin index (LGI-LII) and low glycaemic index, high insulin index (LGI-HII), with a 1-week washout period between meals. At time 0 (just before breakfast), 15, 30, 45, 60, 90, 120, 180 and 240 min after the meal, serum glucose, insulin and C-peptide levels and appetite scores were measured. At the end of 4 h, participants were served ad libitum lunch. Early (0-30 min), late (45-240 min) and total (0-240 min) postprandial insulin responses were lowered by 56·1, 34·6 and 35·6 % after the LGI-LII meal v. LGI-HII meal (P < 0·05). The feeling of hunger was also decreased by 25·8 and 27·5 % after the LGI-LII meal v. LGI-HII meal during the late and total responses (P < 0·05). The calculation II of meals or diets may be a useful dietary approach to reduce postprandial hyperinsulinaemia and the perceived hunger in obese adolescents with IR.",2019,The feeling of hunger was also decreased by 25.8% and 27.5% after LGI-LII meal vs. LGI-HII meal during the late and total responses (p<0.05).,"['obese adolescents with insulin resistance', 'obese adolescents with insulin resistance (IR', '15 obese adolescents aged 12-18 years with IR', 'obese adolescents with IR']",['macronutrient- and glycaemic index-matched meals with either high or low II'],"['postprandial hyperinsulinaemia', 'postprandial metabolic responses and appetite sensations', 'feeling of hunger', 'glycaemic index, low insulin index (LGI-LII) and low glycaemic index, high insulin index (LGI-HII', 'postprandial insulin responses', 'serum glucose, insulin and C-peptide levels, and appetite scores']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",15.0,0.0682935,The feeling of hunger was also decreased by 25.8% and 27.5% after LGI-LII meal vs. LGI-HII meal during the late and total responses (p<0.05).,"[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Caferoglu', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Health Sciences, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hatipoglu', 'Affiliation': 'Department of Paediatric Endocrinology, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gokmen Ozel', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}]",The British journal of nutrition,['10.1017/S0007114519001351']
1184,31174710,Brief interventions for young adults who use drugs: The moderating effects of resilience and trauma.,"Among participants in an intervention clinical trial (N = 602), we examined resilience as a moderator of substance use outcomes by intervention condition and between participants with and without severe traumatic stress (STS). Eligibility included men and women ages 18-39 with recent multidrug use; drug treatment enrollees were excluded. Outcome measures were past 90-day frequencies of substance use and abstinence. Putative moderators were measured using the Resilience Research Centre's Adult Resilience Measure (RRC-ARM) and the Traumatic Stress Scale from the Global Appraisal of Individual Needs (GAIN). Analyses employed hierarchical linear models. High resilience predicted better substance use outcomes, and the ordering of intervention effects for high resilience participants was stepwise by intervention condition intensity. Participants with low resilience scores had poorer outcomes, and those outcomes were largely unaffected by intervention condition. Participants without STS experienced the interventions similarly to the overall sample. Regardless of the level of resilience, however, participants with STS did not benefit from the interventions. The findings point to the importance of screening for both resilience and traumatic stress prior to intervention to maximize the impact of brief interventions for substance users, and also to link those needing more intensive approaches to additional services and professional care.",2019,"High resilience predicted better substance use outcomes, and the ordering of intervention effects for high resilience participants was stepwise by intervention condition intensity.","['participants with and without severe traumatic stress (STS', 'young adults who use drugs', 'Eligibility included men and women ages 18-39 with recent multidrug use; drug treatment enrollees were excluded']",[],"['past 90-day frequencies of substance use and abstinence', ""Resilience Research Centre's Adult Resilience Measure (RRC-ARM) and the Traumatic Stress Scale""]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]",[],"[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}]",,0.08346,"High resilience predicted better substance use outcomes, and the ordering of intervention effects for high resilience participants was stepwise by intervention condition intensity.","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Kurtz', 'Affiliation': 'Center for Applied Research on Substance Use and Health Disparities, Nova Southeastern University, 7255 NE 4(th) Avenue, Suite 112, Miami, FL 33138, USA. Electronic address: steven.kurtz@nova.edu.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Pagano', 'Affiliation': 'Department of Psychiatry, Division of Child Psychiatry, Case Western Reserve University, 10524 Euclid Avenue #1155A, Cleveland, OH 44106, USA. Electronic address: Maria.Pagano@case.edu.'}, {'ForeName': 'Mance E', 'Initials': 'ME', 'LastName': 'Buttram', 'Affiliation': 'Center for Applied Research on Substance Use and Health Disparities, Nova Southeastern University, 7255 NE 4(th) Avenue, Suite 112, Miami, FL 33138, USA. Electronic address: mance.buttram@nova.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ungar', 'Affiliation': 'Resilience Research Centre, Dalhousie University, Halifax, Canada. Electronic address: Michael.Ungar@Dal.Ca.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.03.009']
1185,32492126,Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity: A Randomized Clinical Trial.,"Importance
Early-stage chronic kidney disease (CKD) characterized by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease, and early mortality in patients with type 2 diabetes.
Objective
To compare the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) surgery vs best medical treatment in patients with early-stage CKD, type 2 diabetes, and obesity.
Design, Setting, and Participants
For this randomized clinical trial, patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up.
Intervention
A total of 100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomized 1:1 to receive best medical treatment (n = 49) or RYGB (n = 51).
Main Outcomes and Measures
The primary outcome was remission of albuminuria (uACR <30 mg/g). Secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety.
Results
A total of 100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care. Remission of albuminuria occurred in 55% of patients (95% CI, 39%-70%) after best medical treatment and 82% of patients (95% CI, 72%-93%) after RYGB (P = .006), resulting in CKD remission rates of 48% (95% CI, 32%-64%) after best medical treatment and 82% (95% CI, 72%-92%) after RYGB (P = .002). The geometric mean uACRs were 55% lower after RYGB (10.7 mg/g of creatinine) than after best medical treatment (23.6 mg/g of creatinine) (P < .001). No difference in the rate of serious adverse events was observed.
Conclusions and Relevance
After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity.
Trial Registration
ClinicalTrials.gov Identifier: NCT01821508.",2020,"After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity.
","['Patients With Type 2 Diabetes and Obesity', '100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min', '100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care', 'patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up', 'patients with type 2 diabetes', 'patients with early-stage CKD, type 2 diabetes, and obesity']","['RYGB', 'Gastric Bypass vs Best Medical Treatment', 'Roux-en-Y gastric bypass (RYGB) surgery']","['remission of albuminuria (uACR', 'Remission of albuminuria', 'geometric mean uACRs', 'CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety', 'rate of serious adverse events', 'CKD remission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",100.0,0.0885028,"After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity.
","[{'ForeName': 'Ricardo Vitor', 'Initials': 'RV', 'LastName': 'Cohen', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Tiago Veiga', 'Initials': 'TV', 'LastName': 'Pereira', 'Affiliation': ""Applied Health Research Center, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Cristina Mamédio', 'Initials': 'CM', 'LastName': 'Aboud', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Tarissa Beatrice Zanata', 'Initials': 'TBZ', 'LastName': 'Petry', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Lopes Correa', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Carlos Aurélio', 'Initials': 'CA', 'LastName': 'Schiavon', 'Affiliation': 'Research Institute, Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Pompílio', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Fernando Nogueira Quirino', 'Initials': 'FNQ', 'LastName': 'Pechy', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Ana Carolina Calmon', 'Initials': 'ACC', 'LastName': 'da Costa Silva', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Fernanda Lendimuth Gomes', 'Initials': 'FLG', 'LastName': 'de Melo', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Lívia Porto', 'Initials': 'LP', 'LastName': 'Cunha da Silveira', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Pedro Paulo', 'Initials': 'PP', 'LastName': 'de Paris Caravatto', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Halpern', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Frederico de Lima Jacy', 'Initials': 'FLJ', 'LastName': 'Monteiro', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'da Costa Martins', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Kuga', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Thais Mantovani Sarian', 'Initials': 'TMS', 'LastName': 'Palumbo', 'Affiliation': 'The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.'}, {'ForeName': 'Neil Gerard', 'Initials': 'NG', 'LastName': 'Docherty', 'Affiliation': 'Diabetes Complications Research Center, UCD Conway Institute, University College Dublin School of Medicine, Dublin, Ireland.'}, {'ForeName': 'Carel Wynand', 'Initials': 'CW', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Center, UCD Conway Institute, University College Dublin School of Medicine, Dublin, Ireland.'}]",JAMA surgery,['10.1001/jamasurg.2020.0420']
1186,30497999,To Prompt or Not to Prompt? A Microrandomized Trial of Time-Varying Push Notifications to Increase Proximal Engagement With a Mobile Health App.,"BACKGROUND
Mobile health (mHealth) apps provide an opportunity for easy, just-in-time access to health promotion and self-management support. However, poor user engagement with these apps remains a significant unresolved challenge.
OBJECTIVE
This study aimed to assess the effect of sending versus not sending a push notification containing a contextually tailored health message on proximal engagement, measured here as self-monitoring via the app. Secondary aims were to examine whether this effect varies by the number of weeks enrolled in the program or by weekday versus weekend. An exploratory aim was to describe how the effect on proximal engagement differs between weekday versus weekend by the time of day.
METHODS
The study analyzes the causal effects of push notifications on proximal engagement in 1255 users of a commercial workplace well-being intervention app over 89 days. The app employs a microrandomized trial (MRT) design to send push notifications. At 1 of 6 times per day (8:30 am, 12:30 pm, 5:30 pm, 6:30 pm, 7:30 pm, and 8:30 pm; selected randomly), available users were randomized with equal probability to be sent or not sent a push notification containing a tailored health message. The primary outcome of interest was whether the user self-monitored behaviors and feelings at some time during the next 24 hours via the app. A generalization of log-linear regression analysis, adapted for use with data arising from an MRT, was used to examine the effect of sending a push notification versus not sending a push notification on the probability of engagement over the next 24 hours.
RESULTS
Users were estimated to be 3.9% more likely to engage with the app in the next 24 hours when a tailored health message was sent versus when it was not sent (risk ratio 1.039; 95% CI 1.01 to 1.08; P<.05). The effect of sending the message attenuated over the course of the study, but this effect was not statistically significant (P=.84). The effect of sending the message was greater on weekends than on weekdays, but the difference between these effects was not statistically significant (P=.18). When sent a tailored health message on weekends, the users were 8.7% more likely to engage with the app (95% CI 1.01 to 1.17), whereas on weekdays, the users were 2.5% more likely to engage with the app (95% CI 0.98 to 1.07). The effect of sending a tailored health message was greatest at 12:30 pm on weekends, when the users were 11.8% more likely to engage (90% CI 1.02 to 1.13).
CONCLUSIONS
Sending a push notification containing a tailored health message was associated with greater engagement in an mHealth app. Results suggested that users are more likely to engage with the app within 24 hours when push notifications are sent at mid-day on weekends.",2018,"The effect of sending the message attenuated over the course of the study, but this effect was not statistically significant (P=.84).",['1255 users of a commercial workplace well-being intervention app over 89 days'],"['equal probability to be sent or not sent a push notification containing a tailored health message', 'sending versus not sending a push notification containing a contextually tailored health message']",['user self-monitored behaviors and feelings at some time during the next 24 hours via the app'],"[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]",,0.0685337,"The effect of sending the message attenuated over the course of the study, but this effect was not statistically significant (P=.84).","[{'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Bidargaddi', 'Affiliation': 'Personal Health Informatics, College of Medicine & Public Health, Adelaide, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Insitute for Social Research, Michigan University, Ann Arbor, MI, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Department of Statistics, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Insitute for Social Research, Michigan University, Ann Arbor, MI, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kovalcik', 'Affiliation': 'Insitute for Social Research, Michigan University, Ann Arbor, MI, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pituch', 'Affiliation': 'Jool Health, Ann Arbor, MI, United States.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Maaieh', 'Affiliation': 'Jool Health, Ann Arbor, MI, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Strecher', 'Affiliation': 'Jool Health, Ann Arbor, MI, United States.'}]",JMIR mHealth and uHealth,['10.2196/10123']
1187,31188278,"Type-specific HPV prevalence, incident cases, persistence and associated pregnancy outcomes among HIV-infected women in Kenya.","BACKGROUND
Persistent infection with high-risk types of human papillomavirus (HPV) is the pre-eminent factor driving the development of cervical cancer. There are large gaps in knowledge about both the role of pregnancy in the natural history of HPV infection, and the impact of HPV on pregnancy outcomes.
METHODS
This single-site prospective cohort sub-study, nested within an international multi-site randomized controlled trial, assessed prevalence, incident cases and persistence of type-specific HPV infection, and the association between persistence of high-risk HPV infection with pregnancy outcomes among HIV-infected pregnant women in Kenya, including HIV transmission to infants. Type-specific HPV was assessed using a line probe assay in pregnancy and again at 3 months after delivery. HIV status of children was determined using PCR at 6 weeks.
RESULTS
In total, 84.1% of women (206/245) had a high-risk HPV infection at enrolment. Three quarters of these infections persisted postpartum (157/206). Persistence of HPV16 and/or HPV18 types was observed in over half (53.4%; 39/73) of women with this infection at enrolment. Almost two-thirds had an incident high-risk HPV infection postpartum, which was not present in pregnancy (62.5%), most commonly HPV52 (19.0%). After adjustments, no association was detected between persistent high-risk HPV and preterm birth. All mothers of the seven cases of infant HIV infection had persistent HR-HPV infection (P=0.044).
CONCLUSIONS
High levels of high-risk HPV infection and type-specific persistence were documented, heightening the urgency of mass role out of HPV vaccination. The association between HPV persistence and HIV transmission is a novel finding, warranting further study.",2019,"All mothers of the seven cases of infant HIV infection had persistent HR-HPV infection (P=0.044).
","['HIV-infected pregnant women in Kenya, including HIV transmission to infants', 'HIV-infected women in Kenya']",['HPV16'],"['persistent high-risk HPV and preterm birth', 'incident high-risk HPV infection postpartum', 'persistent HR-HPV infection', 'high-risk HPV infection']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]",,0.164114,"All mothers of the seven cases of infant HIV infection had persistent HR-HPV infection (P=0.044).
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Vyankandondera', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Wambua', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Irungu', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Mandaliya', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Temmerman', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mohamed', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Davy', 'Initials': 'D', 'LastName': 'Vanden Broeck', 'Affiliation': 'International Centre for Reproductive Health, Department of Public Health and Primary Care, Ghent University, Belgium.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Verhelst', 'Affiliation': 'Ghent University, Belgium.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Chersich', 'Affiliation': 'International Centre for Reproductive Health, Department of Public Health and Primary Care, Ghent University, Belgium.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001029']
1188,30893254,Effects of intratracheal captopril on severely meconium-injured piglet lungs.,"BACKGROUND
Severe meconium aspiration syndrome (MAS) may cause intractable respiratory failure in neonates. Targeting the renin-angiotensin system may be an effective way to treat such pulmonary dysfunction. Captopril has the potential to mitigate the severity of lung injury by inhibiting angiotensin-converting enzyme.
METHODS
Twelve newborn piglets were intratracheally instilled with human meconium to induce severe MAS and were randomly treated with IT administration of captopril (0.5 mg/kg) (IT-Cap group, n = 6), or sham air instillation (Control group, n = 6). Cardiopulmonary profiles were monitored for a total of 5 hours. Pulmonary history was examined to compare lung injury severity between groups.
RESULTS
There were no significant differences between the two study groups in gas exchange and lung compliance, peak inspiratory pressure, heart rate, and mean arterial blood pressure over the 5-h experimental period, but there were trends toward lower blood pressure and pH in the IT-Cap group. Histopathological examinations revealed significantly higher lung injury scores in the dependent site of the control group than in the nondependent site of the control group and both sites of the IT-Cap group.
CONCLUSION
Intratracheal captopril did not present significant beneficial effects on severe meconium-injured lungs within 5 hours after injury. Further studies with different disease severities and dosing strategies are required.",2019,"Histopathological examinations revealed significantly higher lung injury scores in the dependent site of the control group than in the nondependent site of the control group and both sites of the IT-Cap group.
","['severely meconium-injured piglet lungs', 'Severe meconium aspiration syndrome (MAS', 'Twelve newborn piglets were intratracheally instilled with human meconium to induce severe MAS', 'neonates']","['Captopril', 'captopril', 'IT administration of captopril', 'intratracheal captopril']","['severe meconium-injured lungs', 'gas exchange and lung compliance, peak inspiratory pressure, heart rate, and mean arterial blood pressure', 'blood pressure and pH', 'lung injury scores']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0025047', 'cui_str': 'Meconium'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0025048', 'cui_str': 'Meconium Aspiration Syndrome'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C4521682', 'cui_str': 'Instill (administration method)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal use'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0025047', 'cui_str': 'Meconium'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0024112', 'cui_str': 'Lung Compliance'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0273115', 'cui_str': 'Pulmonary Injury'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",12.0,0.0299742,"Histopathological examinations revealed significantly higher lung injury scores in the dependent site of the control group than in the nondependent site of the control group and both sites of the IT-Cap group.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute of Emergency and Critical Care Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chih-Hsueh', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Nutrition, College of Medical and Health Care, Hungkuang University, Taichung, Taiwan, ROC.'}, {'ForeName': 'Mei-Jy', 'Initials': 'MJ', 'LastName': 'Jeng', 'Affiliation': 'Institute of Emergency and Critical Care Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000044']
1189,30528222,Cabozantinib Versus Mitoxantrone-prednisone in Symptomatic Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial with a Primary Pain Endpoint.,"BACKGROUND
Bone metastases in patients with metastatic castration-resistant prostate cancer (mCRPC) are associated with debilitating pain and functional compromise.
OBJECTIVE
To compare pain palliation as the primary endpoint for cabozantinib versus mitoxantrone-prednisone in men with mCRPC and symptomatic bone metastases using patient-reported outcome measures.
DESIGN, SETTING, AND PARTICIPANTS
A randomized, double-blind phase 3 trial (COMET-2; NCT01522443) in men with mCRPC and narcotic-dependent pain from bone metastases who had progressed after treatment with docetaxel and either abiraterone or enzalutamide.
INTERVENTION
Cabozantinib 60mg once daily orally versus mitoxantrone 12mg/m 2 every 3wk plus prednisone 5mg twice daily orally.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary endpoint was pain response at week 6 confirmed at week 12 (≥30% decrease from baseline in patient-reported average daily worst pain score via the Brief Pain Inventory without increased narcotic use). The planned sample size was 246 to achieve ≥90% power.
RESULTS AND LIMITATIONS
Enrollment was terminated early because cabozantinib did not demonstrate a survival benefit in the companion COMET-1 trial. At study closure, 119 participants were randomized (cabozantinib: N=61; mitoxantrone-prednisone: N=58). Complete pain and narcotic use data were available at baseline, week 6, and week 12 for 73/106 (69%) patients. There was no significant difference in the pain response with cabozantinib versus mitoxantrone-prednisone: the proportions of responders were 15% versus 17%, a -2% difference (95% confidence interval: -16% to 11%, p=0.8). Barriers to accrual included pretreatment requirements for a washout period of prior anticancer therapy and a narcotic optimization period to maximize analgesic dosing.
CONCLUSIONS
Cabozantinib treatment did not demonstrate better pain palliation than mitoxantrone-prednisone in heavily pretreated patients with mCRPC and symptomatic bone metastases. Future pain-palliation trials should incorporate briefer timelines from enrollment to treatment initiation.
PATIENT SUMMARY
Cabozantinib was not better than mitoxantrone-prednisone for pain relief in patients with castration-resistant prostate cancer and debilitating pain from bone metastases.",2019,"There was no significant difference in the pain response with cabozantinib versus mitoxantrone-prednisone: the proportions of responders were 15% versus 17%, a -2% difference (95% confidence interval: -16% to 11%, p=0.8).","['men with mCRPC and narcotic-dependent pain from bone metastases who had progressed after treatment with', 'patients with metastatic castration-resistant prostate cancer (mCRPC', 'Symptomatic Metastatic Castration-resistant Prostate Cancer', 'heavily pretreated patients with mCRPC and symptomatic bone metastases', '119 participants were randomized (cabozantinib: N=61', 'patients with castration-resistant prostate cancer and debilitating pain from bone metastases', 'men with mCRPC and symptomatic bone metastases using patient-reported outcome measures']","['docetaxel and either abiraterone or enzalutamide', 'mitoxantrone-prednisone', 'Cabozantinib Versus Mitoxantrone-prednisone', 'Cabozantinib 60mg once daily orally versus mitoxantrone 12mg/m 2 every 3wk plus prednisone 5mg twice daily orally']","['pain response', 'survival benefit', 'pain palliation', 'pain relief', 'Complete pain and narcotic use data']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C4237943', 'cui_str': 'cabozantinib 60 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1533720', 'cui_str': 'Prednisone 5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",119.0,0.320849,"There was no significant difference in the pain response with cabozantinib versus mitoxantrone-prednisone: the proportions of responders were 15% versus 17%, a -2% difference (95% confidence interval: -16% to 11%, p=0.8).","[{'ForeName': 'Ethan M', 'Initials': 'EM', 'LastName': 'Basch', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA. Electronic address: ebasch@med.unc.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': 'Prostate Oncology Specialists, Marina del Rey, CA, USA.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, England, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'de Souza', 'Affiliation': 'Western Sydney University School of Medicine, Sydney, Australia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Sydney Medical School, University of Sydney and Sydney Adventist Hospital, Wahroonga, Australia.'}, {'ForeName': 'Ulka', 'Initials': 'U', 'LastName': 'Vaishampayan', 'Affiliation': 'Karmanos Cancer Institute, Detroit, MI, USA.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Schwarz', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': 'Belfast City Hospital, Belfast, Northern Ireland, UK.'}, {'ForeName': 'Arash Rezazadeh', 'Initials': 'AR', 'LastName': 'Kalebasty', 'Affiliation': 'Norton Cancer Institute, Louisville, KY, USA.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreicer', 'Affiliation': 'Emily Couric Clinical Cancer Center, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Texas Oncology Sammons Cancer Center, Dallas, TX, USA.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Antonia V', 'Initials': 'AV', 'LastName': 'Bennett', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Dayan', 'Affiliation': 'Department of Medicine, Genitourinary Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Mangeshkar', 'Affiliation': 'Exelixis, Inc., Alameda, CA, USA.'}, {'ForeName': 'Jaymes', 'Initials': 'J', 'LastName': 'Holland', 'Affiliation': 'Exelixis, Inc., Alameda, CA, USA.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Weitzman', 'Affiliation': 'Exelixis, Inc., Alameda, CA, USA.'}, {'ForeName': 'Howard I', 'Initials': 'HI', 'LastName': 'Scher', 'Affiliation': 'Department of Medicine, Genitourinary Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",European urology,['10.1016/j.eururo.2018.11.033']
1190,31764564,Comparison of Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Eustachian Tube Function.,"INTRODUCTION
Adenoidectomy is one of the most common surgical procedures performed in children in otorhinolaryngology practice. This study aims to compare the conventional curettage adenoidectomy (CCA) and the endoscope-assisted coblation adenoidectomy (EACA) in terms of the postoperative Eustachian tube function and the surgical outcomes.
METHODS
A prospective, randomized, controlled study was carried out at a tertiary referral center and private hospital. Seventy-two adenoid hypertrophy patients without middle ear disease were randomly assigned to 2 groups to be operated via CCA and EACA techniques prior to surgery. Parameters including middle ear pressure values (MEPV), operative time, intraoperative hemorrhage, postoperative residual adenoid tissue, and postoperative pain were compared between groups.
RESULTS
In the CCA group for both ears, there was a statistically significant difference between preoperative mean MEPV and mean MEPV of postoperative day 1, while MEPV returned to normal ranges at the postoperative day 7. No statistically significant differences were observed in mean MEPV on preoperatively and 1st and 7th postoperative days in the EACA group for both right and left ears. Mean operative time was significantly higher in the EACA group compared to the CCA group (P < 0.001). Eight (22.2%) out of 36 patients who underwent CCA had a residual adenoid tissue postoperatively, while there was no residual adenoid tissue in any patients who operated via the EACA technique. Mean pain score on postoperative day 1 and 2 and blood loss were significantly less in the EACA group than the CCA group.
CONCLUSION
Endoscope-assisted coblation adenoidectomy may serve a reasonable alternative to conventional curettage adenoidectomy because it provides Eustachian tube functions preserved, decreased intraoperative hemorrhage, complete resection of the adenoid tissue, and lower pain score.",2020,No statistically significant differences were observed in mean MEPV on preoperatively and 1st and 7th postoperative days in the EACA group for both right and left ears.,"['tertiary referral center and private hospital', 'Seventy-two adenoid hypertrophy patients without middle ear disease']","['EACA', 'endoscope-assisted coblation adenoidectomy (EACA', 'CCA', 'Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy', 'conventional curettage adenoidectomy (CCA', 'Endoscope-assisted coblation adenoidectomy', 'CCA and EACA techniques prior to surgery']","['Mean pain score on postoperative day 1 and 2 and blood loss', 'preoperative mean MEPV and mean MEPV of postoperative day 1, while MEPV', 'Postoperative Eustachian Tube Function', 'Mean operative time', 'middle ear pressure values (MEPV), operative time, intraoperative hemorrhage, postoperative residual adenoid tissue, and postoperative pain', 'mean MEPV']","[{'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001428', 'cui_str': 'Pharyngeal Tonsils'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0457584', 'cui_str': 'Eustachian tube function (observable entity)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0457587', 'cui_str': 'Middle ear pressure (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0001428', 'cui_str': 'Pharyngeal Tonsils'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",,0.043658,No statistically significant differences were observed in mean MEPV on preoperatively and 1st and 7th postoperative days in the EACA group for both right and left ears.,"[{'ForeName': 'Secaattin', 'Initials': 'S', 'LastName': 'Gülşen', 'Affiliation': 'Department of Otorhinolaryngology, Dr Ersin Arslan Training And Research Hospital.'}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Çikrikçi', 'Affiliation': 'Department of Otorhinolaryngology, Yozgat State Hospital, Yozgat, Turkey.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006039']
1191,30977904,Mindfulness-Based Relapse Prevention and Transcranial Direct Current Stimulation to Reduce Heavy Drinking: A Double-Blind Sham-Controlled Randomized Trial.,"BACKGROUND
Mindfulness-based relapse prevention (MBRP) and transcranial direct current stimulation (tDCS) have independently shown benefits for treating alcohol use disorder (AUD). Recent work suggests tDCS may enhance mindfulness. The combination of MBRP and tDCS may provide synergistic benefits and may target both behavioral and neurobiological dysfunctions in AUD. The goal of this double-blind sham-controlled randomized trial was to examine the efficacy of a rolling group MBRP treatment combined with tDCS among individuals interested in reducing their drinking.
METHODS
Individuals who were interested in reducing their alcohol use (n = 84; 40.5% female; mean age = 52.3; 98.9% with current AUD) were randomized to receive active (2.0 milliamps) or sham (0.0 milliamps) anodal tDCS (5 cm × 3 cm electrode) of the right inferior frontal gyrus with the 5 cm × 3 cm cathodal electrode applied to the left upper arm, combined with 8 weeks of outpatient MBRP rolling group treatment. Assessments were conducted at baseline, posttreatment, and 2 months following treatment. The primary outcome was drinks per drinking day, and secondary outcomes were percent heavy drinking days, self-reported craving, alcohol cue reactivity in an alcohol cue task, and response inhibition in a stop signal reaction time task.
RESULTS
Results indicated significant reductions in drinks per drinking day over time, B(SE) = -0.535 (0.16), p = 0.001, and a significant dose effect for number of groups attended, B(SE) = -0.259 (0.11), p = 0.01. There were also significant effects of time and dose for number of groups attended on secondary outcomes of percent heavy drinking days and alcohol cue reactivity. There were no effects of active versus sham tDCS on primary or secondary outcomes.
CONCLUSIONS
Findings from the current study provide initial support for the effectiveness of rolling group MBRP as an outpatient treatment for drinking reduction. The current study did not find additive effects of this tDCS protocol in enhancing MBRP among individuals with drinking reduction goals.",2019,"RESULTS
Results indicated significant reductions in drinks per drinking day over time, B(SE) = -0.535 (0.16), p = 0.001, and a significant dose effect for number of groups attended, B(SE) = ","['Heavy Drinking', 'Individuals who were interested in reducing their alcohol use (n\xa0=\xa084; 40.5% female; mean age\xa0=\xa052.3; 98.9% with current AUD', 'individuals with drinking reduction goals']","['active (2.0 milliamps) or sham (0.0 milliamps) anodal tDCS (5\xa0cm', 'sham tDCS', 'Mindfulness-based relapse prevention (MBRP) and transcranial direct current stimulation (tDCS', 'MBRP treatment combined with tDCS', 'MBRP and tDCS', 'tDCS protocol', 'Mindfulness-Based Relapse Prevention and Transcranial Direct Current Stimulation']","['percent heavy drinking days and alcohol cue reactivity', 'drinks per drinking day, and secondary outcomes were percent heavy drinking days, self-reported craving, alcohol cue reactivity in an alcohol cue task, and response inhibition in a stop signal reaction time task', 'drinks per drinking day over time, B(SE']","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0450172', 'cui_str': 'Milliampere (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0556347', 'cui_str': 'Drinking day (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.202883,"RESULTS
Results indicated significant reductions in drinks per drinking day over time, B(SE) = -0.535 (0.16), p = 0.001, and a significant dose effect for number of groups attended, B(SE) = ","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Elena R', 'Initials': 'ER', 'LastName': 'Stein', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Victoria R', 'Initials': 'VR', 'LastName': 'Votaw', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Stevi J', 'Initials': 'SJ', 'LastName': 'Gallegos', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Clark', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Claus', 'Affiliation': 'Mind Research Network, Albuquerque, New Mexico.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14053']
1192,31168243,Prospective Randomized Controlled Study Comparing Primary Surgery Versus Neoadjuvant Chemotherapy Followed by Surgery in Gastric Carcinoma.,"Neoadjuvant chemotherapy in gastric cancer can treat micro metastatic disease and can increase the resectability rate. The trial was to compare early outcomes after primary surgery versus neoadjuvant chemotherapy followed by surgery in gastric adenocarcinoma. The primary aim of the study was to compare resectability and R0 resection rates in upfront surgery v/s chemotherapy followed by surgery arm. A secondary aim was to see if neoadjuvant chemotherapy is well tolerated or not by comparing postoperative morbidity and mortality. The study consisted of 60 consecutive patients of carcinoma stomach randomized into primary surgery and neoadjuvant chemotherapy followed by surgery arms. Morbidity, pathological status, and mortality data were collected and analyzed. Mean operating time in primary surgery arm was 290 ± 46.5 min, while in NACTarm, it was 316.7 ± 56.6 min, respectively. When postop complications were compared between the arms, it was not significant. Comparing the histopathological report of two groups, there was no significant difference between differentiated, T stage, mean lymph node harvest, R0 resection, PNI, and LVI. Neoadjuvant chemotherapy showed a trend towards improving in the R0 resection rate. There is no increase in postoperative morbidity and mortality with neoadjuvant chemotherapy.",2019,"Comparing the histopathological report of two groups, there was no significant difference between differentiated, T stage, mean lymph node harvest, R0 resection, PNI, and LVI.","['gastric adenocarcinoma', 'Gastric Carcinoma', '60 consecutive patients of carcinoma stomach randomized into']","['upfront surgery v/s chemotherapy', 'neoadjuvant chemotherapy', 'Neoadjuvant chemotherapy', 'primary surgery and neoadjuvant chemotherapy', 'Primary Surgery Versus Neoadjuvant Chemotherapy']","['resectability and R0 resection rates', 'R0 resection rate', 'Morbidity, pathological status, and mortality data', 'resectability rate', 'postoperative morbidity and mortality', 'differentiated, T stage, mean lymph node harvest, R0 resection, PNI, and LVI', 'Mean operating time']","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0699791', 'cui_str': 'Carcinoma of stomach (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",60.0,0.0527145,"Comparing the histopathological report of two groups, there was no significant difference between differentiated, T stage, mean lymph node harvest, R0 resection, PNI, and LVI.","[{'ForeName': '', 'Initials': '', 'LastName': 'Ramachandra', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Hospital, Road no 10, Banjara Hills, Hyderabad, India.'}, {'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Hospital, Road no 10, Banjara Hills, Hyderabad, India.'}, {'ForeName': 'Kvvn', 'Initials': 'K', 'LastName': 'Raju', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Hospital, Road no 10, Banjara Hills, Hyderabad, India.'}, {'ForeName': 'T Subramanyeshwar', 'Initials': 'TS', 'LastName': 'Rao', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Hospital, Road no 10, Banjara Hills, Hyderabad, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Patnaik', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Hospital, Road no 10, Banjara Hills, Hyderabad, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Nusrath', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Hospital, Road no 10, Banjara Hills, Hyderabad, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Santa', 'Affiliation': 'Department of Medical Oncology, Basavatarakam Indo American Hospital, Road no 10, Banjara Hills, Hyderabad, India.'}, {'ForeName': 'Sudha', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Pathology, Basavatarakam Indo American Hospital, Road no 10, Banjara Hills, Hyderabad, India.'}]",Indian journal of surgical oncology,['10.1007/s13193-019-00908-7']
1193,32492104,Exercise Electrocardiography and Computed Tomography Coronary Angiography for Patients With Suspected Stable Angina Pectoris: A Post Hoc Analysis of the Randomized SCOT-HEART Trial.,"Importance
Recent European guidance supports a diminished role for exercise electrocardiography (ECG) in the assessment of suspected stable angina.
Objective
To evaluate the utility of exercise ECG in contemporary practice and assess the value of combined functional and anatomical testing.
Design, Setting, and Participants
This is a post hoc analysis of the Scottish Computed Tomography of the Heart (SCOT-HEART) open-label randomized clinical trial, conducted in 12 cardiology chest pain clinics across Scotland for patients with suspected angina secondary to coronary heart disease. Between November 18, 2010, and September 24, 2014, 4146 patients aged 18 to 75 years with stable angina underwent clinical evaluation and 1417 of 1651 (86%) underwent exercise ECG prior to randomization. Statistical analysis was conducted from October 10 to November 5, 2019.
Interventions
Patients were randomized in a 1:1 ratio to receive standard care plus coronary computed tomography (CT) angiography or to receive standard care alone. The present analysis was limited to the 3283 patients who underwent exercise ECG alone or in combination with coronary CT angiography.
Main Outcomes and Measures
The primary clinical end point was death from coronary heart disease or nonfatal myocardial infarction at 5 years.
Results
Among the 3283 patients (1889 men; median age, 57.0 years [interquartile range, 50.0-64.0 years]), exercise ECG had a sensitivity of 39% and a specificity of 91% for detecting any obstructive coronary artery disease in those who underwent subsequent invasive angiography. Abnormal results of exercise ECG were associated with a 14.47-fold (95% CI, 10.00-20.41; P < .001) increase in coronary revascularization at 1 year and a 2.57-fold (95% CI, 1.38-4.63; P < .001) increase in mortality from coronary heart disease death at 5 years or in cases of nonfatal myocardial infarction at 5 years. Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002). The greatest numerical difference in outcome with CT angiography compared with exercise ECG alone was observed for those with inconclusive results of exercise ECG (6 of 283 [2%] vs 18 of 283 [6%]), although this was not statistically significant (log-rank P = .05).
Conclusions and Relevance
This study suggests that abnormal results of exercise ECG are associated with coronary revascularization and the future risk of adverse coronary events. However, coronary CT angiography more accurately detects coronary artery disease and is more strongly associated with future risk compared with exercise ECG.
Trial Registration
ClinicalTrials.gov Identifier: NCT01149590.",2020,"Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002).","['With Suspected Stable Angina Pectoris', 'Between November 18, 2010, and September 24, 2014, 4146 patients aged 18 to 75 years with stable angina underwent clinical evaluation and 1417 of 1651 (86%) underwent', 'Patients', '12 cardiology chest pain clinics across Scotland for patients with suspected angina secondary to coronary heart disease', '3283 patients who underwent', '3283 patients (1889 men; median age, 57.0 years [interquartile range, 50.0-64.0 years]), exercise ECG had a sensitivity of 39% and a specificity of 91% for detecting any obstructive coronary artery disease in those who underwent subsequent invasive angiography']","['coronary CT angiography', 'exercise ECG', 'Exercise Electrocardiography and Computed Tomography Coronary Angiography', 'exercise electrocardiography (ECG', 'exercise ECG alone or in combination with coronary CT angiography', 'CT angiography', 'standard care plus coronary computed tomography (CT) angiography or to receive standard care alone']","['mortality from coronary heart disease death', 'coronary revascularization', 'exercise ECG', 'death from coronary heart disease or nonfatal myocardial infarction at 5 years', '5-year coronary heart disease death or nonfatal myocardial infarction']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",4146.0,0.139474,"Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002).","[{'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Singh', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'Division of Cardiovascular Medicine, University of Virginia, Charlottesville.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}]",JAMA cardiology,['10.1001/jamacardio.2020.1567']
1194,32492105,A Randomized Trial of Convalescent Plasma for COVID-19-Potentially Hopeful Signals.,,2020,,[],[],[],[],[],[],,0.04554,,"[{'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Casadevall', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Liise-Anne', 'Initials': 'LA', 'LastName': 'Pirofski', 'Affiliation': 'Montefiore Medical Center, Division of Infectious Diseases, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York.'}]",JAMA,['10.1001/jama.2020.10218']
1195,29520735,Neonatal outcomes among twins stratified by method of conception: secondary analysis of maternal fetal medicine (MFMU) network database.,"PURPOSE
To investigate whether twin pregnancies conceived by different forms of fertility treatments are associated with adverse neonatal outcomes and to examine the difference in maternal and obstetrical characteristics between patients.
METHODS
Our study was a retrospective analysis of twin pregnancies conceived by fertility treatments from a prospectively collected database. Treatments were stratified into two groups: group 1 (ART) consisted of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), and group 2 (non-ART) included intrauterine insemination (IUI) and ovulation induction (OI). Composite neonatal morbidity included respiratory distress syndrome, intraventricular hemorrhage, leukomalacia, chronic lung disease, and death prior to discharge.
RESULTS
There were 460 neonates in our study; among them, 67% (n = 310) were in group 1, and 33% (n = 150) in group 2. Group 1 patients were more likely to be older (p = 0.004), nulliparous (p = 0.01), delivered twins with lower birth weights (2278 g ± 605 vs. 2427 ± 519, p = 0.009), and had more deliveries < 32 weeks gestation (p = 0.001). In multivariable Poisson regression model, only neonatal intensive care unit admission rate was increased for group 1 twins (aRR = 1.27, 95% CI 1.003-1.60).
CONCLUSIONS
After adjusting for confounders, twins conceived via ART compared to non-ART had similar neonatal outcomes. These data can help when counseling this patient population and assist in planning larger prospective cohorts.",2018,"Group 1 patients were more likely to be older (p = 0.004), nulliparous (p = 0.01), delivered twins with lower birth weights (2278 g ± 605 vs. 2427 ± 519, p = 0.009), and had more deliveries < 32 weeks gestation (p = 0.001).","['twin pregnancies conceived by fertility treatments from a prospectively collected database', '460 neonates in our study; among them, 67% (n\u2009=\u2009310', 'twins stratified by method of conception: secondary analysis of maternal fetal medicine (MFMU) network database', 'twin pregnancies']","['group 1 (ART) consisted of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), and group 2 (non-ART) included intrauterine insemination (IUI) and ovulation induction (OI']","['neonatal intensive care unit admission rate', 'delivered twins with lower birth weights', 'respiratory distress syndrome, intraventricular hemorrhage, leukomalacia, chronic lung disease, and death prior to discharge']","[{'cui': 'C0152150', 'cui_str': 'Pregnancy, Twin'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0029967', 'cui_str': 'Ovulation Induction'}]","[{'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",,0.242173,"Group 1 patients were more likely to be older (p = 0.004), nulliparous (p = 0.01), delivered twins with lower birth weights (2278 g ± 605 vs. 2427 ± 519, p = 0.009), and had more deliveries < 32 weeks gestation (p = 0.001).","[{'ForeName': 'Jaimin S', 'Initials': 'JS', 'LastName': 'Shah', 'Affiliation': 'Department of Obstetrics & Gynecology, McGovern Medical School at the University of Texas Health Science Center, 6431 Fannin St, Suite 3.214, Houston, TX, 77030, USA. Jaimin.Shah@uth.tmc.edu.'}, {'ForeName': 'Susan Hosseini', 'Initials': 'SH', 'LastName': 'Nasab', 'Affiliation': 'Department of Obstetrics & Gynecology, McGovern Medical School at the University of Texas Health Science Center, 6431 Fannin St, Suite 3.214, Houston, TX, 77030, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Chappell', 'Affiliation': 'Department of Reproductive Endocrinology and Infertility, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Han-Yang', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics & Gynecology, McGovern Medical School at the University of Texas Health Science Center, 6431 Fannin St, Suite 3.214, Houston, TX, 77030, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schutt', 'Affiliation': 'Department of Reproductive Endocrinology and Infertility, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Mendez-Figueroa', 'Affiliation': 'Department of Maternal & Fetal Medicine, McGovern Medical School at the University of Texas Health Science Center, Houston, TX, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-018-1149-x']
1196,29536216,An Exploratory Trial of Transdermal Nicotine for Aggression and Irritability in Adults with Autism Spectrum Disorder.,"Nicotinic acetylcholine receptors (nAChRs), particularly the α7 nAChR, are implicated in the pathophysiology of both autism spectrum disorder (ASD) and aggressive behavior. We explored the feasibility, tolerability, and preliminary efficacy of targeting nAChRs using transdermal nicotine to reduce aggressive symptoms in adults with ASD. Eight subjects were randomized in a double-blind crossover trial of 7 mg transdermal nicotine or placebo, each for 1 week. All participants tolerated nicotine treatment well. Five subjects contributed data to the primary outcome, Aberrant Behavior Checklist-Irritability (ABC-I) subscale change from baseline, which was improved by nicotine compared to placebo. Sleep ratings were also improved by nicotine and correlated with ABC-I improvement. These findings support further investigation of nAChR agonists for aggression and sleep in ASD.",2018,"Five subjects contributed data to the primary outcome, Aberrant Behavior Checklist-Irritability (ABC-I) subscale change from baseline, which was improved by nicotine compared to placebo.","['Eight subjects', 'Adults with Autism Spectrum Disorder', 'adults with ASD']","['Transdermal Nicotine', 'placebo', 'Nicotinic acetylcholine receptors (nAChRs', 'transdermal nicotine', 'nAChR agonists', 'transdermal nicotine or placebo']","['Aberrant Behavior Checklist-Irritability (ABC-I) subscale change', 'Sleep ratings', 'Aggression and Irritability', 'aggressive symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034830', 'cui_str': 'Nicotinic Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",8.0,0.153446,"Five subjects contributed data to the primary outcome, Aberrant Behavior Checklist-Irritability (ABC-I) subscale change from baseline, which was improved by nicotine compared to placebo.","[{'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. alan.lewis@yale.edu.'}, {'ForeName': 'Gerrit Ian', 'Initials': 'GI', 'LastName': 'van Schalkwyk', 'Affiliation': 'Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mayra Ortiz', 'Initials': 'MO', 'LastName': 'Lopez', 'Affiliation': 'Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Fred R', 'Initials': 'FR', 'LastName': 'Volkmar', 'Affiliation': 'Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Marina R', 'Initials': 'MR', 'LastName': 'Picciotto', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Sukhodolsky', 'Affiliation': 'Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-018-3536-7']
1197,31764258,Insights for Implementation Science From 2 Multiphased Studies With End-Users of Potential Multipurpose Prevention Technology and HIV Prevention Products.,"BACKGROUND
Lower adherence to biomedical HIV prevention and challenges with persistence among young women underscore the need for methods to identify factors that will achieve higher adoption and use of effective prevention options and inform new approaches.
SETTING
South Africa, Kenya, and Zimbabwe.
METHODS
We synthesized findings from 2 multiphased studies (TRIO and Quatro) conducted with young women aged 18-30 years that included a crossover clinical study with placebo products, a discrete-choice experiment, and qualitative interviews with women, male partners, and health providers. TRIO evaluated 3 products (tablets, ring, and injections), and Quatro compared 4 vaginal products (ring, insert, film, and gel) for HIV prevention. Both were designed to assess product preferences, choice, and use.
RESULTS
Increased experience with placebo products in the crossover study informed young women's product ratings and preferences. Over half changed their mind regarding their most preferred product after trying each one. The integrated qualitative component was vital to understanding what prompted these preference shifts. The discrete choice experiment provided insights on how features not available in placebos, like efficacy and contraception, influence choice and the tradeoffs women may be willing to make to gain a desired product feature.
CONCLUSION
The use of multiple research methods allowed for evaluation of varied dimensions of acceptability, preference, and choice in the context of diverse biomedical HIV prevention delivery forms. Findings elucidated the value of product choice with differences in preference within and across settings. Collectively, the 3 methodologies offered important insights about these products informative to enhanced product design development and future implementation.",2019,"RESULTS
Increased experience with placebo products in the crossover study informed young women's product ratings and preferences.","['young women', 'South Africa, Kenya, and Zimbabwe', 'young women aged 18-30 years that included a crossover clinical study with placebo products, a discrete-choice experiment, and qualitative interviews with women, male partners, and health providers']",['placebo'],[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0417957,"RESULTS
Increased experience with placebo products in the crossover study informed young women's product ratings and preferences.","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Minnis', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Napierala', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Browne', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002215']
1198,30630649,Duration of asymptomatic status and outcomes following carotid endarterectomy and carotid artery stenting in the Carotid Revascularization Endarterectomy vs Stenting Trial.,"BACKGROUND
Most carotid revascularization studies define asymptomatic as symptom-free for more than 180 days; however, it is unknown if intervention carries similar risk among those currently asymptomatic but with previous symptoms (PS) vs those who were always asymptomatic (AA).
METHODS
We compared the periprocedural and 4-year risks of PS vs AA patients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) randomized to carotid endarterectomy (CEA) or carotid artery stenting (CAS)/angioplasty. Proportional hazards models adjusting for age, sex, and treatment were used to assess the risk of periprocedural stroke and/or death (S+D; any S+D during periprocedural period), stroke and death at 4 years (any S+D within the periprocedural period and ipsilateral stroke out to 4 years) and the primary end point at 4 years (any stroke, death, and myocardial infarction within the periprocedural period and ipsilateral stroke out to 4 years). Analysis was performed pooling the CEA-treated and CAS-treated patients, and separately for each treatment.
RESULTS
Of 1181 asymptomatic patients randomized in CREST, 1104 (93%) were AA and 77 (7%) were PS. There was no difference in risk when comparing the AA and PS cohorts in the pooled CAS+CEA population for periprocedural S+D (2.0% vs 1.3%), S+D at 4 years (3.6% vs 3.2%), or the primary end point (5.2% vs 5.8%). There were also no differences among those assigned to CEA (periprocedural S+D, 1.5% vs 0%; S+D at 4 years, 2.7% vs 0%; or primary end point, 5.1% vs 2.4%) or CAS (periprocedural S+D, 2.5% vs 2.8%; S+D at 4 years, 4.4% vs 6.9%; or primary end point, 5.3% vs 9.8%) when analyzed separately.
CONCLUSIONS
In CREST, only a small minority of asymptomatic patients had previous ipsilateral symptoms. The outcomes of periprocedural S+D, periprocedural S+D, and ipsilateral stroke up to 4 years, and the primary end point did not differ for AA patients compared with PS patients.",2019,"There were also no differences among those assigned to CEA (periprocedural S+D, 1.5% vs 0%; S+D at 4 years, 2.7% vs 0%; or primary end point, 5.1% vs 2.4%) or CAS (periprocedural S+D, 2.5% vs 2.8%; S+D at 4 years, 4.4% vs 6.9%; or primary end point, 5.3% vs 9.8%) when analyzed separately.
","['1181 asymptomatic patients randomized in CREST, 1104 (93%) were AA and 77']","['Carotid Revascularization Endarterectomy', 'carotid endarterectomy and carotid artery stenting', 'carotid endarterectomy (CEA) or carotid artery stenting (CAS)/angioplasty']","['stroke, death, and myocardial infarction within the periprocedural period and ipsilateral stroke out to 4\xa0years', 'periprocedural S+D', 'S+D', 'risk of periprocedural stroke and/or death (S+D; any S+D during periprocedural period), stroke and death', 'periprocedural S+D, periprocedural S+D, and ipsilateral stroke up to 4\xa0years']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2948667', 'cui_str': 'Crest'}]","[{'cui': 'C3495793', 'cui_str': 'Carotid revascularisation'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}, {'cui': 'C0014099', 'cui_str': 'Carotid Endarterectomy'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1181.0,0.119004,"There were also no differences among those assigned to CEA (periprocedural S+D, 1.5% vs 0%; S+D at 4 years, 2.7% vs 0%; or primary end point, 5.1% vs 2.4%) or CAS (periprocedural S+D, 2.5% vs 2.8%; S+D at 4 years, 4.4% vs 6.9%; or primary end point, 5.3% vs 9.8%) when analyzed separately.
","[{'ForeName': 'Wesley S', 'Initials': 'WS', 'LastName': 'Moore', 'Affiliation': 'Division of Vascular Surgery, UCLA Medical Center, Los Angeles, Calif.'}, {'ForeName': 'Jenifer H', 'Initials': 'JH', 'LastName': 'Voeks', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Roubin', 'Affiliation': 'Cardiovascular Associates of the Southeast, Birmingham, Ala.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Clark', 'Affiliation': 'Department of Neurology, Oregon Health and Sciences University, Portland, Ore.'}, {'ForeName': 'Virginia J', 'Initials': 'VJ', 'LastName': 'Howard', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Ala.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jones', 'Affiliation': 'Cardiology Associates, Central Baptist Hospital, Lexington, Ky.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Brott', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, Fla; Department of Surgery, New Jersey Medical School, Rutgers University, The State University of New Jersey, Newark, NJ. Electronic address: brott.thomas@mayo.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery,['10.1016/j.jvs.2018.09.054']
1199,31130827,Intensive Motivational Interviewing for Heavy Drinking among Women.,"Objectives
Women suffer more severe consequences related to heavy drinking than men. Relative to men, women who are heavy drinkers experience higher severity of medical, psychiatric, and social problems, even when they have fewer years drinking. Currently there are few gender-specific, evidence-based interventions for heavy drinking among women.
Methods
A randomized clinical trial was conducted with 215 women with alcohol problems. Half were randomly assigned to receive a 9-session, ""Intensive Motivational Interviewing"" (IMI) intervention (N=107) and half were randomly assigned to a standard single session of MI (SMI) along with 8 sessions of nutritional education (N=108) to achieve time equivalence. Both conditions received weekly outpatient group counseling. Follow-up interviews were conducted at 2 months. Primary outcomes included percent drinking days (PDD), percent heavy drinking days (PHDD, 4+ drinks), and the Addiction Severity Index (ASI) Alcohol scale. Longitudinal changes were assessed using generalized estimating equations (GEE).
Results
The sample was predominantly white (83.3 % ), college educated (61.4 % ), and married (53.5%). The mean age was 50.9 ( sd = 11.3). Relative to baseline, both study conditions showed significant reductions in PDD, PHDD, and ASI alcohol severity (p<.001). Among heavy drinkers, defined as women drinking 14+ days to the point of intoxication over the past 30 days at baseline (N=153), those assigned to IMI (n=67) showed larger reductions in PDD (p<.01) and PHDD (p<.05) at 2-months compared to women receiving SMI.
Conclusions
Findings support the efficacy of IMI for heavy drinking among women. Additional studies are needed that assess drinking over longer time periods.",2019,"Relative to baseline, both study conditions showed significant reductions in PDD, PHDD, and ASI alcohol severity (p<.001).","['The sample was predominantly white (83.3 % ), college educated (61.4 % ), and married (53.5', '215 women with alcohol problems', 'heavy drinking among women', 'Heavy Drinking among Women']","['standard single session of MI (SMI) along with 8 sessions of nutritional education', '9-session, ""Intensive Motivational Interviewing"" (IMI) intervention', 'Intensive Motivational Interviewing']","['PDD, PHDD, and ASI alcohol severity', 'percent drinking days (PDD), percent heavy drinking days (PHDD, 4+ drinks), and the Addiction Severity Index (ASI', 'Alcohol scale', 'PDD (p<.01) and PHDD']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0555047', 'cui_str': 'Married (finding)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index (assessment scale)'}, {'cui': 'C0222045'}]",215.0,0.0587213,"Relative to baseline, both study conditions showed significant reductions in PDD, PHDD, and ASI alcohol severity (p<.001).","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Polcin', 'Affiliation': 'Public Health Institute.'}, {'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Korcha', 'Affiliation': 'Public Health Institute.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Pugh', 'Affiliation': 'Public Health Institute.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Witbrodt', 'Affiliation': 'Public Health Institute.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Salinardi', 'Affiliation': 'Public Health Institute.'}, {'ForeName': 'Gantt', 'Initials': 'G', 'LastName': 'Galloway', 'Affiliation': 'Friends Research Institute.'}, {'ForeName': 'Madhabika B', 'Initials': 'MB', 'LastName': 'Nayak', 'Affiliation': 'Public Health Institute.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Nelson', 'Affiliation': 'Public Health Institute.'}]",Addictive disorders & their treatment,['10.1097/ADT.0000000000000152']
1200,31143442,Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial.,"Background: The best method of antimicrobial prophylaxis administration for surgical site infection (SSI) in transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB) remains controversial. The purpose of this study is to compare one-day and two-day cefazolin in a randomized 2 nd -phase study to help establish a protocol with a 95% confidence interval (CI) for SSI prevention. Methods: Patients undergoing HoLEP/TUEB for benign prostate hyperplasia without preoperative pyuria will be enrolled and randomized to receive prophylactic antibiotic administration for HoLEP/TUEB in two groups, 1-day (single dose) cefazolin and 2-day cefazolin. The primary endpoint is the occurrence rate of postoperative urinary tract infection or urogenital infection within 30 days after HoLEP/TUEB with a statistical 95% CI in comparison between those groups. Secondary outcomes include the kind of infectious disease and evidence of diagnosis, day of diagnosis of infectious disease, performance of urine or blood culture, detection of bacteria, treatments, duration of treatments, AEs other than surgical site infection, and drug-induced AEs. Discussion: The results of this study will provide evidence for defining the optimal duration of cefazolin prophylactic antibiotic administration for SSI. Trial registration: This study was registered in the University Hospital Medical Information Network-Clinical Trial Registry ( UMIN000027955) based on recommendations from the International Committee of Medical Journal Editors (ICMJE) on July 1 st 2017.",2019,The best method of antimicrobial prophylaxis administration for surgical site infection (SSI) in transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB) remains controversial.,"['Holmium Laser enucleation of the prostate (HoLEP', 'for benign prostate hyperplasia without preoperative pyuria']","['HoLEP/TUEB', 'cefazolin and 2-day cefazolin', 'cefazolin', '2-day prophylactic antibiotic administration', 'prophylactic antibiotic administration for HoLEP/TUEB', 'transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB']","['kind of infectious disease and evidence of diagnosis, day of diagnosis of infectious disease, performance of urine or blood culture, detection of bacteria, treatments, duration of treatments, AEs other than surgical site infection, and drug-induced AEs', 'occurrence rate of postoperative urinary tract infection or urogenital infection']","[{'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0034359', 'cui_str': 'Pyuria'}]","[{'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C1273849', 'cui_str': 'Infectious Diseases Specialty'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C1261143', 'cui_str': 'Detection of bacteria'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0403709', 'cui_str': 'Postoperative urinary tract infection (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",2.0,0.224909,The best method of antimicrobial prophylaxis administration for surgical site infection (SSI) in transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB) remains controversial.,"[{'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Shigemura', 'Affiliation': 'Department of Urology, Kobe University, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Fukashi', 'Initials': 'F', 'LastName': 'Yamamichi', 'Affiliation': 'Department of Urology, Hara Genitourinary Hospital, Kobe, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Nishimoto', 'Affiliation': 'Department of Public Health, Kobe University Graduate School of Health Science, Kobe, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': 'Division of Advanced Medical Science, Kobe University Graduate School of Science, Technology and Innovation, Kobe, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fujisawa', 'Affiliation': 'Department of Urology, Kobe University, Kobe, Hyogo, 650-0017, Japan.'}]",F1000Research,['10.12688/f1000research.17660.2']
1201,30920620,Disparate Effect of Aromatization on the Central Regulation of GH Secretion by Estrogens in Men and Postmenopausal Women.,"CONTEXT
Estrogen receptor antagonism by tamoxifen inhibits GH secretion in both men and postmenopausal women, suggesting that estrogen, albeit at low concentration, stimulates GH secretion. However, systemic estrogen replacement in postmenopausal women does not enhance GH secretion. To clarify the role of estrogen in mediating GH secretion, we investigated the effect of estrogen deprivation by using aromatase inhibitors.
AIM
To determine whether estrogens mediate GH secretion in men and postmenopausal women.
DESIGN
The effects of letrozole, an aromatase inhibitor, and tamoxifen were compared in an open-label crossover study. Eight men and 14 women received tamoxifen (20 mg/d) and letrozole (2.5 mg/d) for 2 weeks each. The primary endpoints were GH response to arginine stimulation and gonadal steroid levels.
RESULTS
In men, letrozole significantly (P < 0.05) reduced the peak GH response to arginine (mean ± SEM; Δ -49.4% ± 18.1%). Tamoxifen also reduced the mean peak GH, but this did not reach statistical significance. In postmenopausal women, letrozole did not affect peak GH, whereas tamoxifen significantly (P < 0.05) reduced peak GH (Δ -47.3% ± 10%). In men, letrozole reduced circulating estradiol (from 43.1 ± 2.8 to 12.7 ± 1.3 pmol/L; P < 0.001), whereas in women estradiol was undetectable (<11 pmol/L) at baseline and throughout letrozole therapy.
CONCLUSION
Because estrogen deprivation reduced circulating GH, we conclude that estrogens regulate GH secretion in men. In postmenopausal women, the neutral effect of aromatase inhibition is likely explained by pre-existing estrogen deficiency. The inhibition of GH secretion by tamoxifen in menopause suggests a non-estrogen receptor-mediated mechanism of action. In contrast to men, estrogen is unlikely to mediate GH secretion in postmenopausal women.",2019,"In postmenopausal women, letrozole did not affect peak GH, whereas tamoxifen significantly (P < 0.05) reduced peak GH (Δ -47.3% ± 10%).","['men and postmenopausal women', 'postmenopausal women', 'Eight men and 14 women received', 'Men and Postmenopausal Women']","['Tamoxifen', 'tamoxifen', 'estrogens mediate GH secretion', 'letrozole']","['circulating estradiol', 'mean peak GH', 'GH response to arginine stimulation and gonadal steroid levels', 'peak GH response', 'GH secretion', 'peak GH']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",8.0,0.0577525,"In postmenopausal women, letrozole did not affect peak GH, whereas tamoxifen significantly (P < 0.05) reduced peak GH (Δ -47.3% ± 10%).","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Birzniece', 'Affiliation': 'Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McLean', 'Affiliation': 'School of Medicine, Western Sydney University, Penrith, New South Wales, Australia.'}, {'ForeName': 'Navneeta', 'Initials': 'N', 'LastName': 'Reddy', 'Affiliation': 'Department of Diabetes and Endocrinology, Blacktown Hospital, Blacktown, New South Wales, Australia.'}, {'ForeName': 'Ken K Y', 'Initials': 'KKY', 'LastName': 'Ho', 'Affiliation': 'Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00265']
1202,31039052,Addition of Low-Dose Decitabine to Anti-PD-1 Antibody Camrelizumab in Relapsed/Refractory Classical Hodgkin Lymphoma.,"PURPOSE
Anti-programmed death-1 (PD-1) monotherapy induces a high response rate in patients with relapsed/refractory classic Hodgkin lymphoma (cHL), but complete remission (CR) is infrequently observed. As decitabine is known to boost T-cell function, we assessed the safety and efficacy of anti-PD-1 camrelizumab alone versus decitabine-primed camrelizumab in patients with relapsed/refractory cHL.
METHODS
This two-arm, open-label, phase II study enrolled patients with relapsed/refractory cHL who had received at least two lines of previous therapy. Anti-PD-1 treatment-naïve patients were randomly assigned (1:2) to camrelizumab (200 mg) monotherapy or decitabine (10 mg/d, days 1 to 5) plus camrelizumab (200 mg, day 8) combination therapy every 3 weeks. Patients who were previously treated with anti-PD-1 were assigned combination therapy. Primary end point was CR rate and safety.
RESULTS
Overall, 86 patients were enrolled and evaluated for response, with a median follow-up of 14.9 months. In anti-PD-1-naïve patients, CR rate was 32% (six of 19 patients) with camrelizumab monotherapy versus 71% (30 of 42 patients) who were administered decitabine plus camrelizumab ( P = .003). At the time of analysis, the response duration rate at 6 months was 76% on camrelizumab monotherapy versus 100% on decitabine plus camrelizumab. For patients who were previously treated with anti-PD-1, 28% achieved CR and 24% partial response after decitabine plus camrelizumab. Ten patients maintained a response at more than 6 months and 81% of responders were estimated to have a response at more than 1 year. For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting.
CONCLUSION
CR rate in patients with relapsed/refractory cHL who were clinically naïve to PD-1 blockade was significantly higher with decitabine plus camrelizumab than with camrelizumab alone. Decitabine plus camrelizumab may reverse resistance to PD-1 inhibitors in patients with relapsed/refractory cHL.",2019,"For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting.
","['Refractory Classical Hodgkin Lymphoma', 'patients with relapsed/refractory classic Hodgkin lymphoma (cHL', '86 patients were enrolled and evaluated for response, with a median follow-up of 14.9 months', 'Patients who were previously treated with anti-PD-1', 'enrolled patients with relapsed/refractory cHL who had received at least two lines of previous therapy', 'patients with relapsed/refractory cHL', 'Anti-PD-1 treatment-naïve patients']","['decitabine plus camrelizumab', 'Decitabine plus camrelizumab', 'camrelizumab monotherapy', 'open-label', 'camrelizumab', 'camrelizumab (200 mg) monotherapy or decitabine']","['safety and efficacy', 'response duration rate', 'CR rate and safety', 'PD-1 blockade', 'CR rate']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",86.0,0.043294,"For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Chunmeng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Mei', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Ku', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Meixia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'An', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Malcolm V', 'Initials': 'MV', 'LastName': 'Brock', 'Affiliation': '2 John Hopkins University, Baltimore, MD.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02151']
1203,31042410,"Prospective, Multicenter, Randomized Phase III Trial Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in Early Breast Cancer: SenSzi (GBG80) Trial.","PURPOSE
The aim of the current work was to clarify whether a preoperative lymphoscintigraphy (LSG) enhances staging accuracy of sentinel lymph node biopsy (SLNB).
PATIENTS AND METHODS
In a prospective, multicenter, randomized phase III trial, patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB were randomly assigned 1:1 to receive SLNB either with knowledge of the LSG findings or without. As the false-negative rate of SLNB correlates with the number of resected sentinel lymph nodes (SLNs), our primary end point was the mean number of histologically detected SLNs per patient. One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG. Stratified one-sided 95% CI for the difference (without LSG - with LSG) in the mean number of histologically detected SLNs had to be greater than -0.27 (10% noninferiority margin). Stratification was performed according to tumor focality and trial site. Additional predefined secondary end points (rates of node-positive patients and of completion axillary lymph node dissection) were analyzed to rule out differences in the reliable detection of nodal metastases.
RESULTS
Between May 2014 and October 2015, 1,198 patients were randomly assigned in 23 German and Swiss breast centers. Modified intention-to-treat analysis (n = 1,163) showed a mean number of histologically detected SLNs of 2.21 with LSG and 2.26 without LSG (difference 0.05; stratified 95% CI, -0.18 to infinity), thus establishing noninferiority of omitting preoperative LSG. Secondary end points displayed no statistically significant differences.
CONCLUSION
We show that SLNB is equally effective irrespective of the surgeon's knowledge of preoperative LSG results. SLNB without LSG will speed up the preoperative workflow and reduce cost.",2019,One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG.,"['Early Breast Cancer', 'sentinel lymph node biopsy (SLNB', 'One thousand one hundred two evaluable patients', 'Between May 2014 and October 2015, 1,198 patients were randomly assigned in 23 German and Swiss breast centers', 'patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB']","['Lymphoscintigraphy', 'preoperative lymphoscintigraphy (LSG', 'SLNB']",['mean number of histologically detected SLNs'],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}]","[{'cui': 'C0412375', 'cui_str': 'Lymphoscintigraphy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}]",1198.0,0.128431,One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG.,"[{'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kuemmel', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Holtschmidt', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': '2 University of Rostock, Rostock, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Von der Assen', 'Affiliation': '3 Niels-Stensen-Kliniken, Georgsmarienhütte, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': '4 University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Thill', 'Affiliation': '5 Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': '4 University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': '6 University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': '8 Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Lubitz', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Jens Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': '9 Breast Center of the Charité, Berlin, Germany.'}, {'ForeName': 'Mattea', 'Initials': 'M', 'LastName': 'Reinisch', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hötzeldt', 'Affiliation': '11 Brustzentrum Asklepios Harzklinik, Goslar, Germany.'}, {'ForeName': 'Fenja', 'Initials': 'F', 'LastName': 'Seither', 'Affiliation': '10 German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': '10 German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Schwidde', 'Affiliation': '12 Die Frauenärztinnen Mülheim an der Ruhr, Mülheim, Germany.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Uhrhan', 'Affiliation': '13 Zentrum für Nuklearmedizin und Molekulare Bildgebung Essen, Essen, Germany.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Von Minckwitz', 'Affiliation': '10 German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Rezai', 'Affiliation': '14 Luisenkrankenhaus Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Mulowski', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': '10 German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kuehn', 'Affiliation': '15 Clinic Esslingen, Esslingen, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02092']
1204,31062997,Reduced Reward Responsiveness Predicts Change in Depressive Symptoms in Anxious Children and Adolescents Following Treatment.,"Objectives: Reduced reward responsiveness, as measured by the event-related potential (ERP) component, the reward positivity (RewP), has been shown to play a role in the development of internalizing disorders, but implications for treatment remain unclear. In adult patients with anxiety and/or depression, reduced RewP has emerged as a predictor of greater change in symptoms following cognitive behavior therapy (CBT) or selective serotonin reuptake inhibitor (SSRI) treatment. The objectives of this preliminary study were to extend these findings to children and adolescents with anxiety disorders by evaluating RewP to reward as a predictor of change in anxiety severity or depressive symptoms following treatment with CBT or SSRI and to explore whether RewP differentially predicts response to one type of treatment. Methods: Patients (7-19 years old) with social and/or generalized anxiety disorder ( N = 27) completed baseline measures of anxiety severity and depressive symptoms, as well as an ERP monetary reward anticipation and feedback task. RewP was measured in response to reward and breaking even feedback. Patients were then randomly assigned to CBT or SSRI treatment, and completed measures of anxiety and depressive symptom severity at the last treatment session. Results: Reduced reward responsiveness, as measured by RewP to rewards, predicted greater change in depressive symptoms following treatment, adjusting for baseline symptoms, age, and RewP to breaking even. RewP was not a significant predictor of change in anxiety symptoms. Although preliminary, exploratory analyses suggested that among anxious youth, RewP specifically predicted change in depressive symptoms following CBT, rather than SSRI. Conclusion: Results provide preliminary support for the utility of ERP measures of reward responsiveness in predicting treatment response in youth. With further research and standardization, ERP assessments could potentially be implemented in clinical settings to inform prognosis and treatment planning for youth with internalizing disorders.",2019,"Although preliminary, exploratory analyses suggested that among anxious youth, RewP specifically predicted change in depressive symptoms following CBT, rather than SSRI. ","['Anxious Children and Adolescents Following Treatment', 'children and adolescents with anxiety disorders', 'adult patients with anxiety and/or depression', 'Methods: Patients (7-19 years old) with social and/or generalized anxiety disorder ( N \u2009=\u200927', 'youth with internalizing disorders', 'youth']",['CBT or SSRI'],"['reward responsiveness, as measured by the event-related potential (ERP) component, the reward positivity (RewP', 'anxiety severity and depressive symptoms, as well as an ERP monetary reward anticipation and feedback task', 'depressive symptoms', 'anxiety and depressive symptom severity', 'anxiety symptoms', 'Reduced reward responsiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0656652,"Although preliminary, exploratory analyses suggested that among anxious youth, RewP specifically predicted change in depressive symptoms following CBT, rather than SSRI. ","[{'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Kujawa', 'Affiliation': '1 Department of Psychology and Human Development, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Burkhouse', 'Affiliation': '2 Department of Psychiatry, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Karich', 'Affiliation': '2 Department of Psychiatry, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Kate D', 'Initials': 'KD', 'LastName': 'Fitzgerald', 'Affiliation': '3 Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Monk', 'Affiliation': '3 Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': '2 Department of Psychiatry, University of Illinois at Chicago, Chicago, Illinois.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0172']
1205,30848791,Separate and Combined Effects of GIP and GLP-1 Infusions on Bone Metabolism in Overweight Men Without Diabetes.,"CONTEXT
The gut-derived incretin hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) have been suggested to play a role in bone metabolism. Exogenous administration of GIP inhibits bone resorption, but the effect of GLP-1 is less clear. Furthermore, the combined effect of exogenous GIP and GLP-1 on bone metabolism is unknown.
OBJECTIVE
To investigate the effect of separate and combined infusions of the incretin hormones GIP and GLP-1 on bone resorption and formation.
DESIGN
Randomized, double-blinded, placebo-controlled, crossover study including five study days.
PARTICIPANTS
Seventeen overweight/obese men.
INTERVENTIONS
On the first study day, a 50-g oral glucose tolerance test (OGTT) was performed. On the next four study days, isoglycemic IV glucose infusions (IIGI), mimicking the glucose excursions from the OGTT, were performed with concomitant infusions of GIP (4 pmol/kg/min), GLP-1 (1 pmol/kg/min), GIP+GLP-1 (4 and 1 pmol/kg/min, respectively), or placebo, respectively.
PRIMARY OUTCOMES
Changes in bone resorption assessed by measurements of carboxy-terminal type I collagen crosslinks (CTX) and in bone formation as assessed by procollagen type 1 N-terminal propeptide (P1NP) concentrations.
RESULTS
During the OGTT, CTX was significantly lowered by 54 ± 13% from baseline (mean ± SD) compared with 28 ± 12% during IIGI + saline (P < 0.0001). During IIGI+GLP-1 and IIGI+GIP, CTX was lowered by 65 ± 16% and 74 ± 9%, respectively, from baseline, whereas IGII+GIP+GLP-1 lowered CTX by 84 ± 4% from baseline. P1NP levels were unaffected by the interventions.
CONCLUSIONS
Our data suggest that GLP-1, like GIP, may be involved in regulation of bone resorption and that GIP and GLP-1 together have partially additive inhibitory effects.",2019,"P1NP levels were unaffected by the interventions.
","['Overweight Men Without Diabetes', 'Seventeen overweight/obese men']","['GIP', 'placebo', 'GIP+GLP-1', 'exogenous GIP and GLP-1', 'GIP and GLP-1 Infusions']","['P1NP levels', 'Bone Metabolism', 'bone resorption and formation', 'bone resorption assessed by measurements of carboxy-terminal type I collagen crosslinks (CTX) and in bone formation as assessed by procollagen type 1 N-terminal propeptide (P1NP) concentrations']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.259867,"P1NP levels were unaffected by the interventions.
","[{'ForeName': 'Natasha Chidekel', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Lærke Smidt', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Chemistry, Rigshospitalet, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Jessen', 'Affiliation': 'Department of In Vivo Pharmacology, Zealand Pharma A/S, Glostrup, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel Bring', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Filip Krag', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00008']
1206,31169077,Electronic Cigarette Use During a Randomized Trial of Interventions for Smoking Cessation Among Medicaid Beneficiaries with Mental Illness.,"Objective: People with mental illness have high rates of cigarette smoking, but many wish to quit. Electronic cigarette (e-cigarette) use has become increasingly common, especially among smokers who wish to quit, but research on whether this facilitates quitting has been mixed, and little research has examined e-cigarette use among smokers with mental illness. This secondary analysis examined the associations between spontaneous e-cigarette use during cessation treatment and 6-month outcomes within a cessation trial among Medicaid beneficiaries with mental illness. Main outcomes were previously reported. Methods: Adult Medicaid beneficiaries receiving mental health services were recruited between 2012 and 2015. Eligible daily smokers were randomized, using equipoise stratification, to one of six cessation treatment conditions (combinations of prescriber visit for pharmacotherapy, behavioral interventions, and abstinence incentives; e-cigarette use was not a recommended intervention). Presence of any self-reported e-cigarette use, all tobacco product use, quit attempts, and biologically verified abstinence were assessed at 3, 6, 9, and 12 months. The 456 participants who completed the 6-month assessment were included in logistic regressions, adjusting for subject characteristics and treatment condition, examining associations between self-reported, spontaneous e-cigarette use and 6-month outcomes. We evaluated three outcomes: biologically verified abstinence at 6 months, quit attempts over the treatment period, and heavy smoking (≥20 cigarettes per day) at 6 months. Results: Any use of e-cigarettes was reported by 192 participants (42.1%) during the treatment period. Use of pharmacotherapy was not different between those who used e-cigarettes and those who did not use e-cigarettes. A total of 13.5% of participants ( n = 61) had achieved biologically verified abstinence at the 6-month assessment. E-cigarettes were not significantly associated with biologically verified abstinence, use of cessation pharmacotherapy, self-reported quit attempts, or heavy smoking at the 6-month assessment. Conclusions: Spontaneous e-cigarette use during cessation treatment was common among smokers with mental illness and was not associated with positive or negative treatment outcomes. The high rate of naturalistic e-cigarette use in this group suggests that e-cigarettes are an appealing strategy to obtain nicotine during cessation treatment that could be harnessed as a smoking cessation tool or for harm reduction.",2019,"E-cigarettes were not significantly associated with biologically verified abstinence, use of cessation pharmacotherapy, self-reported quit attempts, or heavy smoking at the 6-month assessment. ","['People with mental illness', 'Adult Medicaid beneficiaries receiving mental health services were recruited between 2012 and 2015', 'Medicaid beneficiaries with mental illness', 'Eligible daily smokers', '456 participants who completed the 6-month assessment were included in logistic regressions, adjusting for subject characteristics and treatment condition, examining associations between self-reported, spontaneous e-cigarette use and 6-month outcomes', 'smokers with mental illness']","['Electronic cigarette (e-cigarette', 'pharmacotherapy', 'Electronic cigarette']","['biologically verified abstinence, use of cessation pharmacotherapy, self-reported quit attempts, or heavy smoking']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.0249034,"E-cigarettes were not significantly associated with biologically verified abstinence, use of cessation pharmacotherapy, self-reported quit attempts, or heavy smoking at the 6-month assessment. ","[{'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Bianco', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine, Dartmouth , Hanover , NH , USA.'}, {'ForeName': 'Sarah I', 'Initials': 'SI', 'LastName': 'Pratt', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine, Dartmouth , Hanover , NH , USA.'}, {'ForeName': 'Joelle C', 'Initials': 'JC', 'LastName': 'Ferron', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine, Dartmouth , Hanover , NH , USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Brunette', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine, Dartmouth , Hanover , NH , USA.'}]",Journal of dual diagnosis,['10.1080/15504263.2019.1620400']
1207,31153789,Different weekly frequencies of Pilates did not accelerate pain improvement in patients with chronic low back pain.,"BACKGROUND
Recent evidence recommends Pilates for the treatment of chronic low back pain. However, it is still unknown if different weekly frequencies of Pilates can accelerate the improvement of symptoms in patients with chronic low back pain verified by a daily pain assessment.
OBJECTIVE
To analyze whether different weekly frequencies of Pilates can accelerate pain reduction by 30%, 50%, and 100% in patients with non-specific chronic low back pain and the necessary number of weeks to reach these improvements.
METHODS
Two hundred and twenty-two patients were randomized into three groups: Pilates group 1 received treatment once a week, Pilates group 2 received treatment twice a week, and Pilates group 3 received treatment three times a week. All groups received Pilates for six weeks. Pain intensity was measured daily before and after each intervention session using the Pain Numerical Rating Scale. The assessor was not blind.
RESULTS
The survival analysis showed that all Pilates groups had a pain reduction of 30%, 50%, and 100% at the same speed during treatment. There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05). After the first week of treatment, 44.6% of the patients in Pilates group 3 showed complete pain improvement, followed by 37.8% of the patients in Pilates group 2 and 29.7% in Pilates group 1. After the last week, 71.6% (Pilates group 1), 77% (Pilates group 2), and 78.4% (Pilates group 3) of the patients reported complete improvement of symptoms.
CONCLUSION
Different weekly frequencies of Pilates did not accelerate pain improvement in patients with non-specific chronic low back pain. Registered in Clinical Trials Registry: NCT02241538 (https://clinicaltrials.gov/ct2/show/NCT02241538).",2020,There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05).,"['Two hundred and twenty-two patients', 'patients with chronic low back pain', 'patients with non-specific chronic low back pain', 'chronic low back pain']",[],"['pain improvement', 'pain reduction', 'Pain intensity', 'complete improvement of symptoms', 'survival analysis', 'Pain Numerical Rating Scale', 'complete pain improvement']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0222045'}]",222.0,0.0593448,There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05).,"[{'ForeName': 'Maria Liliane da', 'Initials': 'MLD', 'LastName': 'Silva', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}, {'ForeName': 'Gisela Cristiane', 'Initials': 'GC', 'LastName': 'Miyamoto', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil. Electronic address: gfisio_miyamoto@hotmail.com.""}, {'ForeName': 'Katherinne Ferro Moura', 'Initials': 'KFM', 'LastName': 'Franco', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}, {'ForeName': 'Yuri Rafael Dos Santos', 'Initials': 'YRDS', 'LastName': 'Franco', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}, {'ForeName': 'Cristina Maria Nunes', 'Initials': 'CMN', 'LastName': 'Cabral', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.05.001']
1208,31629570,"Efficacy, safety and immunogenicity of a pneumococcal protein-based vaccine co-administered with 13-valent pneumococcal conjugate vaccine against acute otitis media in young children: A phase IIb randomized study.","BACKGROUND
Native American populations experience a substantial burden of pneumococcal disease despite use of highly effective pneumococcal conjugate vaccines (PCVs). Protein-based pneumococcal vaccines may extend protection beyond the serotype-specific protection elicited by PCVs.
METHODS
In this phase IIb, double-blind, controlled trial, 6-12 weeks-old Native American infants randomized 1:1, received either a protein-based pneumococcal vaccine (dPly/PhtD) containing pneumolysin toxoid (dPly, 10 µg) and pneumococcal histidine triad protein D (PhtD, 10 µg) or placebo, administered along with 13-valent PCV (PCV13) at ages 2, 4, 6 and 12-15 months. Other pediatric vaccines were given per the routine immunization schedule. We assessed vaccine efficacy (VE) against acute otitis media (AOM) and acute lower respiratory tract infection (ALRI) endpoints. Immunogenicity, reactogenicity and unsolicited adverse events were assessed in a sub-cohort and serious adverse events were assessed in all children.
RESULTS
1803 infants were randomized (900 dPly/PhtD; 903 Control). VE against all episodes of American Academy of Pediatrics (AAP)-defined AOM was 3.8% (95% confidence interval: -11.4, 16.9). Point estimates of VE against other AOM outcomes ranged between 2.9% (-9.5, 14.0) and 5.2% (-8.0, 16.8). Point estimates of VE against ALRI outcomes ranged between -4.4% (-39.2, 21.8) and 2.0% (-18.3, 18.8). Point estimates of VE tended to be higher against first than all episodes but the confidence intervals included zero. dPly/PhtD vaccine was immunogenic and had an acceptable reactogenicity and safety profile after primary and booster vaccination in Native American infants.
CONCLUSIONS
The dPly/PhtD vaccine was immunogenic and well tolerated, however, incremental efficacy in preventing AAP-AOM over PCV13 was not demonstrated.
CLINICAL TRIALS REGISTRATION
NCT01545375 (www.clinicaltrials.gov).",2019,"dPly/PhtD vaccine was immunogenic and had an acceptable reactogenicity and safety profile after primary and booster vaccination in Native American infants.
","['young children', 'Native American infants', '1803 infants']","['protein-based pneumococcal vaccine (dPly/PhtD) containing pneumolysin toxoid (dPly, 10\u202fµg) and pneumococcal histidine triad protein D (PhtD, 10\u202fµg) or placebo', 'Protein-based pneumococcal vaccines', 'pneumococcal protein-based vaccine co-administered with 13-valent pneumococcal conjugate vaccine']","['Efficacy, safety and immunogenicity', 'Immunogenicity, reactogenicity and unsolicited adverse events', 'vaccine efficacy (VE) against acute otitis media (AOM) and acute lower respiratory tract infection (ALRI) endpoints', 'acceptable reactogenicity and safety profile']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0071313', 'cui_str': 'plY protein, Streptococcus pneumoniae'}, {'cui': 'C0040555', 'cui_str': 'Toxoids'}, {'cui': 'C0385592', 'cui_str': 'histidine triad protein'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media (disorder)'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection (disorder)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",1803.0,0.433478,"dPly/PhtD vaccine was immunogenic and had an acceptable reactogenicity and safety profile after primary and booster vaccination in Native American infants.
","[{'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Hammitt', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States. Electronic address: LHammitt@JHU.edu.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Campbell', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Weatherholtz', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Reid', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Novalene', 'Initials': 'N', 'LastName': 'Goklish', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Traskine', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'XPE Pharma & Science c/o GSK, Wavre, Belgium.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Swinnen', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Mathuram', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': ""O'Brien"", 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.09.076']
1209,31068270,"Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.","BACKGROUND
Bictegravir co-formulated with emtricitabine and tenofovir alafenamide as a fixed-dose combination is recommended for treatment of HIV-1-infection and might be better tolerated than other integrase inhibitor-based single-tablet regimens, but long-term outcomes data are not available. We assessed the efficacy, safety and tolerability of bictegravir, emtricitabine, and tenofovir alafenamide compared with co-formulated dolutegravir, abacavir, and lamivudine at week 96.
METHODS
This ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial was done at 122 outpatient centres in nine countries. We enrolled adults (aged ≥18 years) living with HIV who were treatment naive and HLA-B*5701 negative, did not have hepatitis B virus infection, and had an estimated glomerular filtration rate of at least 50 mL/min. We randomly assigned participants (1:1) to receive co-formulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (the bictegravir group) or co-formulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg (the dolutegravir group), each with matching placebo, once daily for 144 weeks. Treatment allocation was masked to all participants and investigators. All participants who received at least one dose of study drug were included in primary efficacy and safety analyses. We previously reported the primary endpoint. Here, we report the week 96 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 96 by US Food and Drug Administration snapshot algorithm, with a prespecified non-inferiority margin of -12%. This study was registered with ClinicalTrials.gov, number NCT02607930.
FINDINGS
Between Nov 13, 2015, and July 14, 2016, we screened 739 participants, of whom 108 were excluded and 631 enrolled and randomly assigned to bictegravir, emtricitabine, and tenofovir alafenamide (n=316) or dolutegravir, abacavir, and lamivudine (n=315). Two participants in the bictegravir group did not receive at least one dose of their assigned drug and were excluded from analyses. At week 96, bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to dolutegravir, abacavir, and lamivudine, with 276 (88%) of 314 participants in the bictegravir group versus 283 (90%) of 315 participants in the dolutegravir group achieving HIV-1 RNA less than 50 copies per mL (difference -1·9%; 95% CI -6·9 to 3·1). The most common adverse events were nausea (36 [11%] of 314 for the bictegravir group vs 76 [24%] of 315 for the dolutegravir group), diarrhoea (48 [15%] vs 50 [16%]), and headache (41 [13%] vs 51 [16%]). 36 (11%) participants in the bictegravir group versus 39 (12%) participants in the dolutegravir group had a serious adverse event. Two individuals died in the bictegravir group (recreational drug overdose and suicide, neither of which was treatment related) and none died in the dolutegravir group. No participants discontinued because of adverse events in the bictegravir group compared with five (2%) of 315 in the dolutegravir group. Study drug-related adverse events were reported for 89 (28%) participants in the bictegravir group and 127 (40%) in the dolutegravir group.
INTERPRETATION
These week 96 data support bictegravir, emtricitabine, and tenofovir alafenamide as a safe, well tolerated, and durable treatment for people living with HIV-1 with no emergent resistance.
FUNDING
Gilead Sciences, Inc.",2019,No participants discontinued because of adverse events in the bictegravir group compared with five (2%) of 315 in the dolutegravir group.,"['HIV-1 infection', 'enrolled adults (aged ≥18 years) living with HIV who were treatment naive and HLA-B*5701 negative, did not have hepatitis B virus infection, and had an estimated glomerular filtration rate of at least 50 mL/min', 'people living with HIV-1 with no emergent resistance', 'Between Nov 13, 2015, and July 14, 2016, we screened 739 participants, of whom 108 were excluded and 631 enrolled and randomly assigned to', '122 outpatient centres in nine countries', 'n=315']","['Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine', 'dolutegravir group achieving HIV-1 RNA', 'bictegravir, emtricitabine, and tenofovir alafenamide (n=316) or dolutegravir, abacavir, and lamivudine', 'emtricitabine 200 mg, and tenofovir', 'emtricitabine and tenofovir alafenamide', 'bictegravir', 'bictegravir, emtricitabine, and tenofovir alafenamide compared with co-formulated dolutegravir, abacavir, and lamivudine', 'alafenamide 25 mg (the bictegravir group) or co-formulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg (the dolutegravir group), each with matching placebo']","['serious adverse event', 'efficacy, safety and tolerability', 'adverse events', 'headache', 'diarrhoea', 'proportion of participants with plasma HIV-1 RNA less', 'nausea']","[{'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0440557', 'cui_str': 'B*5701 (substance)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine / tenofovir alafenamide'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C1594209', 'cui_str': 'emtricitabine 200 MG [Emtriva]'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C1629814', 'cui_str': 'abacavir 600 MG'}, {'cui': 'C1166421', 'cui_str': 'Lamivudine 300 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",739.0,0.593634,No participants discontinued because of adverse events in the bictegravir group compared with five (2%) of 315 in the dolutegravir group.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wohl', 'Affiliation': 'Department of Medicine, Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Yazdan', 'Initials': 'Y', 'LastName': 'Yazdanpanah', 'Affiliation': 'Department of Medicine, Paris Diderot University, Paris, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Baumgarten', 'Affiliation': 'Zentrum für Infektiologie Berlin Prenzlauer Berg, Berlin, Germany.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Claude Nicol Centre, Royal Sussex County Hospital, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hagins', 'Affiliation': 'Georgia Department of Public Health, Coastal Health District, Chatham Care Center, Savannah, GA, USA.'}, {'ForeName': 'Moti N', 'Initials': 'MN', 'LastName': 'Ramgopal', 'Affiliation': 'Midway Immunology Center, Fort Pierce, FL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antinori', 'Affiliation': 'National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, Roma, Italy.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Biometrics, Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Acosta', 'Affiliation': 'Department of Virology, Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences Inc, Foster City, CA, USA. Electronic address: sean.collins@gilead.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences Inc, Foster City, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30077-3']
1210,31068272,"Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.","BACKGROUND
The single-tablet regimen consisting of bictegravir, emtricitabine, and tenofovir alafenamide is recommended for treatment of HIV-1 infection on the basis of data from 48 weeks of treatment. Here, we examine the longer-term efficacy, safety, and tolerability of bictegravir, emtricitabine, and tenofovir alafenamide compared with dolutegravir plus co-formulated emtricitabine and tenofovir alafenamide at week 96.
METHODS
This ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial was done at 126 outpatient centres in ten countries. We enrolled treatment-naive adults (aged ≥18 years) with HIV-1 infection who had an estimated glomerular filtration rate of at least 30 mL/min and sensitivity to emtricitabine and tenofovir. People with chronic hepatitis B or C infection, or both, and those who had used antivirals previously for prophylaxis were allowed. We randomly assigned participants (1:1) to receive treatment with either co-formulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (the bictegravir group) or dolutegravir 50 mg with co-formulated emtricitabine 200 mg and tenofovir alafenamide 25 mg (the dolutegravir group), each with matching placebo, once daily for 144 weeks. Treatment allocation was masked to all participants and investigators. All participants who received at least one dose of study drug were included in primary efficacy and safety analyses. We previously reported the primary endpoint. Here, we report the week 96 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 96 by US Food and Drug Administration snapshot algorithm, with a prespecified non-inferiority margin of -12%. This study was registered with ClinicalTrials.gov, number NCT02607956.
FINDINGS
Between Nov 13, 2015, and July 14, 2016, we screened 742 individuals, of whom 657 were enrolled. 327 participants were assigned to the bictegravir group and 330 to the dolutegravir group. Of these, 320 in the bictegravir group and 325 in the dolutegravir group received at least one dose of study drug. At week 96, HIV-1 RNA less than 50 copies per mL was achieved by 269 (84%) of 320 participants in the bictegravir group and 281 (86%) of 325 in the dolutegravir group (difference -2·3%, 95% CI -7·9 to 3·2), demonstrating non-inferiority of the bictegravir regimen compared with the dolutegravir regimen. Both treatments continued to be well tolerated through 96 weeks; 283 (88%) of 320 participants in the bictegravir group and 288 (89%) of 325 in the dolutegravir group had any adverse event and 55 (17%), and 33 (10%) had any serious adverse event. The most common adverse events were diarrhoea (57 [18%] of 320 in the bictegravir group vs 51 [16%] of 325 in the dolutegravir group) and headache (51 [16%] of 320 vs 48 [15%] of 325). Deaths were reported for three (1%) individuals in each group (one cardiac arrest, one gastric adenocarcinoma, and one hypertensive heart disease and congestive cardiac failure in the bictegravir group and one unknown causes, one pulmonary embolism, and one lymphoma in the dolutegravir group); none were considered to be treatment related. Adverse events led to discontinuation in six (2%) participants in the bictegravir group and five (2%) in the dolutegravir group; one of these events in the bictegravir group versus four in the dolutegravir group occurred between weeks 48 and 96. Study drug-related adverse events were reported for 64 (20%) participants in the bictegravir group and 92 (28%) in the dolutegravir group.
INTERPRETATION
These week 96 data support bictegravir, emtricitabine, and tenofovir alafenamide as a safe, well tolerated, and durable treatment for people living with chronic HIV.
FUNDING
Gilead Sciences, Inc.",2019,"Both treatments continued to be well tolerated through 96 weeks; 283 (88%) of 320 participants in the bictegravir group and 288 (89%) of 325 in the dolutegravir group had any adverse event and 55 (17%), and 33 (10%) had any serious adverse event.","['enrolled treatment-naive adults (aged ≥18 years) with HIV-1 infection who had an estimated glomerular filtration rate of at least 30 mL/min and sensitivity to', 'Between Nov 13, 2015, and July 14, 2016, we screened 742 individuals, of whom 657 were enrolled', 'HIV-1 infection', '126 outpatient centres in ten countries', '327 participants were assigned to the bictegravir group and 330 to the dolutegravir group', 'people living with chronic HIV', 'People with chronic hepatitis B or C infection, or both, and those who had used antivirals previously for prophylaxis were allowed']","['alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide', 'emtricitabine and tenofovir', 'co-formulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg (the bictegravir group) or dolutegravir 50 mg with co-formulated emtricitabine 200 mg and tenofovir alafenamide 25 mg (the dolutegravir group), each with matching placebo', 'Co-formulated bictegravir, emtricitabine, and tenofovir', 'dolutegravir plus co-formulated emtricitabine and tenofovir alafenamide', 'bictegravir', 'bictegravir, emtricitabine, and tenofovir alafenamide']","['hypertensive heart disease and congestive cardiac failure', 'serious adverse event', 'Deaths', 'adverse events', 'headache', 'diarrhoea', 'proportion of participants with plasma HIV-1 RNA less', 'longer-term efficacy, safety, and tolerability', 'adverse event']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine / tenofovir alafenamide'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C4551053', 'cui_str': 'bictegravir 50 MG'}, {'cui': 'C1594209', 'cui_str': 'emtricitabine 200 MG [Emtriva]'}, {'cui': 'C4293420', 'cui_str': 'tenofovir alafenamide 25 MG [Vemlidy]'}, {'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}]","[{'cui': 'C0152105', 'cui_str': 'Hypertensive heart disease (disorder)'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",327.0,0.332056,"Both treatments continued to be well tolerated through 96 weeks; 283 (88%) of 320 participants in the bictegravir group and 288 (89%) of 325 in the dolutegravir group had any adverse event and 55 (17%), and 33 (10%) had any serious adverse event.","[{'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Stellbrink', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Department of HIV and Infectious Diseases, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Stephens', 'Affiliation': 'Department of Internal Medicine, Mercer University School of Medicine, Macon, GA, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Albrecht', 'Affiliation': 'Department of Internal Medicine, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Creticos', 'Affiliation': 'Howard Brown Health Center, Chicago, IL, USA.'}, {'ForeName': 'Claudia T', 'Initials': 'CT', 'LastName': 'Martorell', 'Affiliation': 'Infectious Disease and The Research Institute, Springfield, MA, USA.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Acosta', 'Affiliation': 'Department of Virology, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA. Electronic address: sean.collins@gilead.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30080-3']
1211,31758326,Utility of topical agents for radiation dermatitis and pain: a randomized clinical trial.,"PURPOSE
Although topical agents are often provided during radiation therapy, there is limited consensus and evidence for their use prophylactically to prevent or reduce radiation dermatitis.
METHODS
This was a multi-site, randomized, placebo-controlled, blinded study of 191 breast cancer patients to compare the prophylactic effectiveness of three topical agents (Curcumin, HPR Plus™, and Placebo) for reducing radiation dermatitis and associated pain. Patients applied the topical agent to their skin in the radiation area site three times daily starting the first day of radiation therapy (RT) until 1 week after RT completion.
RESULTS
Of the 191 randomized patients, 171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88)). Mean radiation dermatitis severity (RDS) scores did not significantly differ between study arms (Curcumin = 2.68 [2.49, 2.86]; HPR Plus™ = 2.64 [2.45, 2.82]; Placebo = 2.63 [2.44, 2.83]; p = 0.929). Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018). In patients with high breast field separation (≥ 25 cm), RDS scores (Curcumin = 2.70 [2.21, 3.19]; HPR Plus™ = 3.57 [3.16, 4.00]; Placebo = 2.95 [2.60, 3.30]; p = 0.024) and pain scores (Curcumin = 0.52 [- 0.28, 1.33]; HPR Plus™ = 0.55 [- 0.19, 1.30]; Placebo = 1.73 [0.97, 2.50]; p = 0.046) significantly differed at the end of RT.
CONCLUSIONS
Although there were no significant effects of the treatment groups on the overall population, our exploratory subgroup analysis suggests that prophylactic treatment with topical curcumin may be effective for minimizing skin reactions and pain for patients with high breast separation (≥ 25 cm) who may have the worst skin reactions.",2020,Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018).,"['radiation dermatitis and pain', '191 breast cancer patients', '191 randomized patients', '171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88', 'patients with high breast separation (≥ 25 cm) who may have the worst skin reactions']","['placebo', 'topical agents', 'topical agents (Curcumin, HPR Plus™, and Placebo']","['pain scores', 'RDS scores', 'radiation dermatitis severity', 'prophylactic effectiveness', 'Mean radiation dermatitis severity (RDS) scores', 'skin reactions and pain', 'radiation dermatitis and associated pain']","[{'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0423754', 'cui_str': 'Poor skin condition (finding)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",191.0,0.2804,Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018).,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ryan Wolf', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA. julie_ryan@urmc.rochester.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Gewandter', 'Affiliation': 'Department of Anesthesiology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bautista', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Heckler', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Strasser', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark, DE, USA.'}, {'ForeName': 'Pawal', 'Initials': 'P', 'LastName': 'Dyk', 'Affiliation': 'Heartland Cancer Research NCORP, St. Louis, MO, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Columbus NCORP, Columbus, OH, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gross', 'Affiliation': 'Dayton Clinical Oncology Program, Dayton, OH, USA.'}, {'ForeName': 'Tod', 'Initials': 'T', 'LastName': 'Speer', 'Affiliation': 'Metro-Minnesota NCORP, St. Louis Park, MN, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Dolohanty', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bylund', 'Affiliation': 'Department Radiation Oncology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Pentland', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Morrow', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05166-5']
1212,31075323,The beneficial effects of Mediterranean diet over low-fat diet may be mediated by decreasing hepatic fat content.,"BACKGROUND & AIM
It is unclear if a reduction in hepatic fat content (HFC) is a major mediator of the cardiometabolic benefit of lifestyle intervention, and whether it has prognostic significance beyond the loss of visceral adipose tissue (VAT). In the present sub-study, we hypothesized that HFC loss in response to dietary interventions induces specific beneficial effects independently of VAT changes.
METHODS
In an 18-month weight-loss trial, 278 participants with abdominal obesity/dyslipidemia were randomized to low-fat (LF) or Mediterranean/low-carbohydrate (MED/LC + 28 g walnuts/day) diets with/without moderate physical activity. HFC and abdominal fat-depots were measured using magnetic resonance imaging at baseline, after 6 (sub-study, n = 158) and 18 months.
RESULTS
Of 278 participants (mean HFC 10.2% [range: 0.01%-50.4%]), the retention rate was 86.3%. The %HFC substantially decreased after 6 months (-6.6% absolute units [-41% relatively]) and 18 months (-4.0% absolute units [-29% relatively]; p <0.001 vs. baseline). Reductions of HFC were associated with decreases in VAT beyond weight loss. After controlling for VAT loss, decreased %HFC remained independently associated with reductions in serum gamma glutamyltransferase and alanine aminotransferase, circulating chemerin, and glycated hemoglobin (p <0.05). While the reduction in HFC was similar between physical activity groups, MED/LC induced a greater %HFC decrease (p = 0.036) and greater improvements in cardiometabolic risk parameters (p <0.05) than the LF diet, even after controlling for VAT changes. Yet, the greater improvements in cardiometabolic risk parameters induced by MED/LC were all markedly attenuated when controlling for HFC changes.
CONCLUSIONS
%HFC is substantially reduced by diet-induced moderate weight loss and is more effectively reduced by the MED/LC diet than the LF diet, independently of VAT changes. The beneficial effects of the MED/LC diet on specific cardiometabolic parameters appear to be mediated more by decreases in %HFC than VAT loss.
LAY SUMMARY
High hepatic fat content is associated with metabolic syndrome, type 2 diabetes mellitus, and coronary heart disease. In the CENTRAL 18-month intervention trial, a Mediterranean/low-carbohydrate diet induced a greater decrease in hepatic fat content than a low-fat diet, conferring beneficial health effects that were beyond the favorable effects of visceral fat loss. ClinicalTrials.gov Identifier: NCT01530724.",2019,"While the reduction in HFC was similar between physical activity groups, MED/LC induced a greater %HFC decrease (p = 0.036) and greater improvements in cardiometabolic risk parameters (p <0.05) than the LF diet, even after controlling for VAT changes.","['278 participants with abdominal obesity/dyslipidemia', '278 participants']","['Mediterranean/low-carbohydrate diet', 'Mediterranean diet', 'MED/LC diet', 'low-fat (LF) or Mediterranean/low-carbohydrate (MED/LC']","['HFC and abdominal fat-depots', 'Reductions of HFC', 'moderate weight loss', 'VAT beyond weight loss', 'cardiometabolic risk parameters', 'hepatic fat content', 'VAT loss', 'retention rate', 'serum gamma glutamyltransferase and alanine aminotransferase, circulating chemerin, and glycated hemoglobin', 'HFC decrease', 'specific cardiometabolic parameters', 'HFC']","[{'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",278.0,0.0264818,"While the reduction in HFC was similar between physical activity groups, MED/LC induced a greater %HFC decrease (p = 0.036) and greater improvements in cardiometabolic risk parameters (p <0.05) than the LF diet, even after controlling for VAT changes.","[{'ForeName': 'Yftach', 'Initials': 'Y', 'LastName': 'Gepner', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine and Sylvan Adams Sports Institute, Tel Aviv University, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shelef', 'Affiliation': 'Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Komy', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Schwarzfuchs', 'Affiliation': 'Soroka University Medical Center, Beer-Sheva, Israel; Nuclear Research Center-Negev, Dimona, Israel.'}, {'ForeName': 'Nitzan', 'Initials': 'N', 'LastName': 'Bril', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Rein', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Serfaty', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Kenigsbuch', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Yaskolka Meir', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Lilac', 'Initials': 'L', 'LastName': 'Tene', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Avital', 'Initials': 'A', 'LastName': 'Bilitzky', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Yoash', 'Initials': 'Y', 'LastName': 'Chassidim', 'Affiliation': 'Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Sarusy', 'Affiliation': 'Nuclear Research Center-Negev, Dimona, Israel.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Ceglarek', 'Affiliation': 'Department of Medicine, University of Leipzig, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Thiery', 'Affiliation': 'Department of Medicine, University of Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumvoll', 'Affiliation': 'Department of Medicine, University of Leipzig, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Department of Medicine, University of Leipzig, Germany.'}, {'ForeName': 'Meir J', 'Initials': 'MJ', 'LastName': 'Stampfer', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Rudich', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: irish@bgu.ac.il.'}]",Journal of hepatology,['10.1016/j.jhep.2019.04.013']
1213,31755310,Dietary Practices and Meal Patterns among Overweight and Obese School Children in Malaysia: Baseline Data from a School-Based Intervention Study.,"This study aimed to determine dietary practices and meal patterns among Malaysian overweight and obese school children at baseline. This study was part of a school-based obesity intervention study, My Body is Fit and Fabulous at School (MyBFF@school). It involved 1045 primary and 1041 secondary overweight and obese school children from a randomly selected 23 out of 1196 primary and 15 out of 416 secondary government schools in central Peninsular Malaysia. The results showed a significantly higher of adequate intake (4-8 servings/day) of cereals and grains among primary (54.7%) than secondary school children (48.2%). About 28.2% of primary and 32.6% of secondary school children had consumed adequate fruit (2 servings/day), while a very low percentage of both primary (5.0%) and secondary (3.6%) school children consumed adequate vegetables (3 servings/day). As for the meal patterns, school children in both primary and secondary were not taking breakfast regularly (mean±SD for primary: 3.16 ± 2.61 days/week vs secondary: 2.97 ± 2.52 days/week). There was also a significantly higher mean frequency of primary school children brought plain water to school than the secondary school children. In conclusion, urgent actions to address improper dietary practices and meal patterns of overweight and obese school children in Malaysia are warranted.",2020,The results showed a significantly higher of adequate intake (4-8 servings/day) of cereals and grains among primary (54.7%) than secondary school children (48.2%).,"['1045 primary and 1041 secondary overweight and obese school children from a randomly selected 23 out of 1196 primary and 15 out of 416 secondary government schools in central Peninsular Malaysia', 'overweight and obese school children in Malaysia', 'Malaysian overweight and obese school children at baseline', 'Overweight and Obese School Children in Malaysia']",[],['adequate intake'],"[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454750', 'cui_str': 'Peninsular Malaysia (geographic location)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}]",[],"[{'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]",1196.0,0.014681,The results showed a significantly higher of adequate intake (4-8 servings/day) of cereals and grains among primary (54.7%) than secondary school children (48.2%).,"[{'ForeName': 'Rusidah', 'Initials': 'R', 'LastName': 'Selamat', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Junidah', 'Initials': 'J', 'LastName': 'Raib', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Nur Azlina', 'Initials': 'NA', 'LastName': 'Abdul Aziz', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Norlida', 'Initials': 'N', 'LastName': 'Zulkafly', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Ainan Nasrina', 'Initials': 'AN', 'LastName': 'Ismail', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'W Nurul Ashikin', 'Initials': 'WNA', 'LastName': 'W Mohamad', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Nur Izzatun Nasriah', 'Initials': 'NIN', 'LastName': 'Nasruddin', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Muhammad Yazid', 'Initials': 'MY', 'LastName': 'Jalaludin', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Malaya , Kuala Lumpur, Malaysia.'}, {'ForeName': 'Fuziah', 'Initials': 'F', 'LastName': 'Md Zain', 'Affiliation': 'Paediatric Department, Putrajaya Hospital, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Zahari', 'Initials': 'Z', 'LastName': 'Ishak', 'Affiliation': 'Department of Educational Psychology and Counseling, Faculty of Education, University of Malaya , Kuala Lumpur, Malaysia.'}, {'ForeName': 'Abqariyah', 'Initials': 'A', 'LastName': 'Yahya', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya , Kuala Lumpur, Malaysia.'}, {'ForeName': 'Abdul Halim', 'Initials': 'AH', 'LastName': 'Mokhtar', 'Affiliation': 'Department of Sport Sciences, Faculty of Medicine, University of Malaya , Kuala Lumpur, Malaysia.'}]",Ecology of food and nutrition,['10.1080/03670244.2019.1694922']
1214,31669450,Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study.,"BACKGROUND
Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection.
METHODS
The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT.
CONCLUSIONS
This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.",2019,"Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk.","['eight states where 754 HCV-infected PWID', 'people who inject drugs']","['direct-acting antiviral agents (DAAs', 'hepatitis C treatment', 'two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) ', 'PN or mDOT']","['failure to achieve SVR, DAA resistance, and HCV reinfection', 'virologic response (SVR) rates']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0003451', 'cui_str': 'Antiviral Drugs'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205339', 'cui_str': 'Reinfection (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",,0.0854155,"Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk.","[{'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Litwin', 'Affiliation': 'Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, University of South Carolina School of Medicine, Greenville, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA. Electronic address: Alain.Litwin@prismahealth.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jost', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Wagner', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Public Health Sciences, College of Behavioral, Social, and Health Sciences, Clemson University Clemson, SC, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Karasz', 'Affiliation': 'Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Feinberg', 'Affiliation': 'Department of Behavioral Medicine & Psychiatry and Department of Medicine, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Arthur Y', 'Initials': 'AY', 'LastName': 'Kim', 'Affiliation': 'Department of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Lum', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Shruti H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Taylor', 'Affiliation': 'College of Pharmacy, University of Rhode Island, CODAC Behavioral Health, Providence, RI, USA.'}, {'ForeName': 'Judith I', 'Initials': 'JI', 'LastName': 'Tsui', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pericot-Valverde', 'Affiliation': 'Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.105859']
1215,31204198,Effect of single-dose intravenous tranexamic acid on postoperative nasal bleed in septoplasty.,"OBJECTIVE
Postoperative nasal bleeding is a common complication of septoplasty and may lead to painful procedure of nasal packing to stop bleeding. Since Tranexamic acid (TXA) has been reported to reduce bleeding, the purpose of this study is to investigate the effect of single dose of intravenous TXA on postoperative nasal bleed associated with septoplasty.
MATERIALS AND METHODS
This prospective randomized, double-blinded clinical trial consisted of 176 patients aged 18-55 years who underwent septoplasty for symptomatic deviated nasal septum. These participants were randomly divided into 2 groups; 88 patients were given normal saline (Control group) and 88 patients were administered a single shot of intravenous TXA 10mg/kg (TXA group). Operative technique applied was same in all cases. At the end of surgery nasal packs, nasal splints or trans-septal suturing were not done. Nasal bleeding was monitored after surgery and up to 2 weeks postoperatively.
RESULTS
Patients receiving TXA showed significantly less postoperative nasal bleeding compared with controls. Extensive bleeding in terms of number of gauze pads used and duration was also higher in placebo with a statistically significant difference (all P=<0.05). Seven patients required nasal packing in control group to stop bleeding as compared to one patient in TXA group. Adverse reactions to TXA were minimal, and these were easily managed conservatively.
CONCLUSION
Single intravenous dose of TXA is shown to be effective and safe agent in preventing postoperative nasal bleeding after septoplasty therefore avoiding additional techniques of nasal packing, intranasal splint or trans-septal suturing during surgery.",2019,Extensive bleeding in terms of number of gauze pads used and duration was also higher in placebo with a statistically significant difference (all P=<0.05).,"['176 patients aged 18-55 years who underwent septoplasty for symptomatic deviated nasal septum', 'septoplasty']","['tranexamic acid', 'TXA', 'Tranexamic acid (TXA', 'normal saline (Control group) and 88 patients were administered a single shot of intravenous TXA 10mg/kg (TXA', 'surgery nasal packs, nasal splints or trans-septal suturing']","['postoperative nasal bleed', 'postoperative nasal bleeding', 'Adverse reactions', 'nasal packing', 'Nasal bleeding', 'Extensive bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum (disorder)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0490829', 'cui_str': 'Nasal splint'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}]",176.0,0.0392402,Extensive bleeding in terms of number of gauze pads used and duration was also higher in placebo with a statistically significant difference (all P=<0.05).,"[{'ForeName': 'S U', 'Initials': 'SU', 'LastName': 'Zaman', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Liaquat National Hospital & Medical College, Karachi, Pakistan. Electronic address: shakeek_120@hotmail.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Zakir', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Liaquat National Hospital & Medical College, Karachi, Pakistan.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Faraz', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Liaquat National Hospital & Medical College, Karachi, Pakistan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Akhtar', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Liaquat National Hospital & Medical College, Karachi, Pakistan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nawaz', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Liaquat National Hospital & Medical College, Karachi, Pakistan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Adeel', 'Affiliation': 'Department of Head & Neck Surgical Oncology, Shaukat Khanum Memorial Cancer Hospital, Lahore, Pakistan.'}]","European annals of otorhinolaryngology, head and neck diseases",['10.1016/j.anorl.2018.10.019']
1216,31374252,Change in Psychotropic Prescribing Patterns Among Youths in Foster Care Associated With a Peer-to-Peer Physician Consultation Program.,"There has been growing concern about the safety and efficacy of psychotropic prescribing practices for children enrolled in Medicaid and in foster care. 1 In response, accreditation organizations and policymakers have developed standards for optimal use of psychotropic medications among children. 2 In addition, federal legislation has prompted states to implement monitoring programs to address quality and safety issues among vulnerable pediatric subpopulations. 3,4 Here, we report findings from an evaluation of Indiana's program for foster youth, which used outlier case review followed by peer-to-peer consultation between prescribing physicians and child and adolescent psychiatrists. We observed clinically and statistically significant reductions in polypharmacy, off-label prescribing, inpatient hospitalizations, health care costs, and related outcomes among youths randomized to an immediate intervention group compared to no improvements in a waitlist control group.",2019,"We observed clinically and statistically significant reductions in polypharmacy, off-label prescribing, inpatient hospitalizations, health care costs, and related outcomes among youths randomized to an immediate intervention group compared to no improvements in a waitlist control group.","['children enrolled in Medicaid and in foster care', 'children', '3,4', 'Youths in Foster Care']",[],"['polypharmacy, off-label prescribing, inpatient hospitalizations, health care costs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",[],"[{'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C1096117', 'cui_str': 'Off-Label Prescribing'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",,0.022105,"We observed clinically and statistically significant reductions in polypharmacy, off-label prescribing, inpatient hospitalizations, health care costs, and related outcomes among youths randomized to an immediate intervention group compared to no improvements in a waitlist control group.","[{'ForeName': 'Brea', 'Initials': 'B', 'LastName': 'Perry', 'Affiliation': 'Indiana University, Bloomington. Electronic address: blperry@indiana.edu.'}, {'ForeName': 'Kelda Harris', 'Initials': 'KH', 'LastName': 'Walsh', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Plawecki', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Jill C', 'Initials': 'JC', 'LastName': 'Fodstad', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Hillary S', 'Initials': 'HS', 'LastName': 'Blake', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'Purdue University College of Pharmacy, West Lafayette, IN.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rowlison', 'Affiliation': 'Indiana Department of Child Services, Fort Wayne.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'McConnell', 'Affiliation': 'Florida Atlantic University, Boca Raton.'}, {'ForeName': 'Katlyn', 'Initials': 'K', 'LastName': 'Kleimola', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Hulvershorn', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.06.014']
1217,31155169,Comparing intranasal ketamine with intravenous fentanyl in reducing pain in patients with renal colic: A double-blind randomized clinical trial.,"BACKGROUND
Kidney stones are a fairly common problem that manifests itself as symptoms of acute abdominal and flank pains in patients presenting to emergency departments.
OBJECTIVE
The present study was conducted to compare the analgesic effect of intravenous fentanyl with that of intranasal ketamine in renal colic patients.
METHODS
One mg/kg of intranasal ketamine was administered in the first group, and one μg/kg of intravenous fentanyl in the second group. The pain severity was measured in the patients in terms of a visual analogue scale (VAS) score at the beginning of the study and at minutes 5, 15 and 30, and the medication side-effects were evaluated and recorded.
RESULTS
A total of 130 patients were ultimately assessed in two groups of 65. In the ketamine group, the mean severity of pain was 8.72 ± 1.52 at the beginning of the study (P < 0.001), 5.5 ± 2.97 at minute 5 (P < 0.001), 3.38 ± 3.35 at minute 15 (P = 0.004) and 2.53 ± 3.41 at minute 30 (P = 0.449). In the fentanyl group, this severity was 9.66 ± 88.8 in the beginning of the study (P < 0.001), 7.27 ± 1.37 at minute 5 (P < 0.001), 4.61 ± 1.5 at minute 15 (P = 0.004) and 1.24 ± 1.25 at minute 30 (P = 0.449). The general prevalence of the medication side-effects was 10 (15.4%) in the ketamine group and 1 (1.5%) in the fentanyl group (P = 0.009).
CONCLUSIONS
Ketamine was found to be less effective than fentanyl in controlling renal colic-induced pain, and to be associated with a higher prevalence of side-effects; nevertheless, ketamine can be effective in controlling this pain in conjunction with other medications.",2020,"The general prevalence of the medication side-effects was 10 (15.4%) in the ketamine group and 1 (1.5%) in the fentanyl group (P = 0.009).
","['130 patients were ultimately assessed in two groups of 65', 'patients with renal colic', 'patients presenting to emergency departments', 'renal colic patients']","['ketamine', 'fentanyl', 'intranasal ketamine', 'Ketamine', 'intravenous fentanyl']","['visual analogue scale (VAS) score', 'pain', 'mean severity of pain', 'analgesic effect', 'pain severity']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",130.0,0.114413,"The general prevalence of the medication side-effects was 10 (15.4%) in the ketamine group and 1 (1.5%) in the fentanyl group (P = 0.009).
","[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Mozafari', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Maleki Verki', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: drmalaki676@yahoo.com.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Motamed', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sabouhi', 'Affiliation': 'Emergency Medicine Specialist, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Tirandaz', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.05.049']
1218,31152598,Prolonged-Release Tacrolimus Is Less Susceptible to Interaction With the Strong CYP3A Inhibitor Voriconazole in Healthy Volunteers.,"The nature and extent of drug-drug interactions between oral drugs is affected by numerous modulators. The effect of the formulation (prolonged release (PR) vs. immediate release (IR)) of a victim drug during treatment with a CYP3A (cytochrome P450 enzyme 3A4) inhibitor is unknown but expected to be smaller with PR. We studied PR and IR tacrolimus during treatment with the strong CYP3A inhibitor voriconazole in 18 healthy volunteers in a pharmacokinetic, four-phase, crossover trial. The exposure increase was significantly smaller after PR tacrolimus than after IR tacrolimus (AUC (area under the curve) 2.62-fold vs. 6.02-fold, P < 0.001; C max (maximum concentration) 2.02-fold vs. 2.7-fold, P = 0.026) and less variable (AUC increase 1.6 to 4.8-fold vs. 1.8 to 19-fold). CYP3A5 genotype, voriconazole exposure, and CYP3A4 phenotype (determined with a midazolam microdose) were not related to the relative change in tacrolimus exposure. Thus, when considering drug-drug interactions with CYP3A inhibitors, the formulation of orally administered victim drugs should also be considered.",2019,"The exposure increase was significantly smaller after PR tacrolimus than after IR tacrolimus (AUC (area under the curve) 2.62-fold vs. 6.02-fold, P ","['18 healthy volunteers', 'Healthy Volunteers']","['CYP3A inhibitor voriconazole', 'CYP3A Inhibitor Voriconazole', 'PR tacrolimus', 'PR and IR tacrolimus']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850056', 'cui_str': 'CYP3A Inhibitors'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",[],18.0,0.0436131,"The exposure increase was significantly smaller after PR tacrolimus than after IR tacrolimus (AUC (area under the curve) 2.62-fold vs. 6.02-fold, P ","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Huppertz', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Department of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Kathrin I', 'Initials': 'KI', 'LastName': 'Foerster', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Burhenne', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zorn', 'Affiliation': 'Central Laboratory, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Walter E', 'Initials': 'WE', 'LastName': 'Haefeli', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Czock', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1529']
1219,31156083,Sixteen-week versus standard eight-week prednisolone therapy for childhood nephrotic syndrome: the PREDNOS RCT.,"BACKGROUND
The optimal corticosteroid regimen for treating the presenting episode of steroid-sensitive nephrotic syndrome (SSNS) remains uncertain. Most UK centres use an 8-week regimen, despite previous systematic reviews indicating that longer regimens reduce the risk of relapse and frequently relapsing nephrotic syndrome (FRNS).
OBJECTIVES
The primary objective was to determine whether or not an extended 16-week course of prednisolone increases the time to first relapse. The secondary objectives were to compare the relapse rate, FRNS and steroid-dependent nephrotic syndrome (SDNS) rates, requirement for alternative immunosuppressive agents and corticosteroid-related adverse events (AEs), including adverse behaviour and costs.
DESIGN
Randomised double-blind parallel-group placebo-controlled trial, including a cost-effectiveness analysis.
SETTING
One hundred and twenty-five UK paediatric departments.
PARTICIPANTS
Two hundred and thirty-seven children presenting with a first episode of SSNS. Participants aged between 1 and 15 years were randomised (1 : 1) according to a minimisation algorithm to ensure balance of ethnicity (South Asian, white or other) and age (≤ 5 or ≥ 6 years).
INTERVENTIONS
The control group ( n = 118) received standard course (SC) prednisolone therapy: 60 mg/m 2 /day of prednisolone in weeks 1-4, 40 mg/m 2 of prednisolone on alternate days in weeks 5-8 and matching placebo on alternate days in weeks 9-18 (total 2240 mg/m 2 ). The intervention group ( n = 119) received extended course (EC) prednisolone therapy: 60 mg/m 2 /day of prednisolone in weeks 1-4; started at 60 mg/m 2 of prednisolone on alternate days in weeks 5-16, tapering by 10 mg/m 2 every 2 weeks (total 3150 mg/m 2 ).
MAIN OUTCOME MEASURES
The primary outcome measure was time to first relapse [Albustix ® (Siemens Healthcare Limited, Frimley, UK)-positive proteinuria +++ or greater for 3 consecutive days or the presence of generalised oedema plus +++ proteinuria]. The secondary outcome measures were relapse rate, incidence of FRNS and SDNS, other immunosuppressive therapy use, rates of serious adverse events (SAEs) and AEs and the incidence of behavioural change [using Achenbach Child Behaviour Checklist (ACBC)]. A comprehensive cost-effectiveness analysis was performed. The analysis was by intention to treat. Participants were followed for a minimum of 24 months.
RESULTS
There was no significant difference in time to first relapse between the SC and EC groups (hazard ratio 0.87, 95% confidence interval 0.65 to 1.17; log-rank p = 0.3). There were also no differences in the incidence of FRNS (SC 50% vs. EC 53%; p = 0.7), SDNS (44% vs. 42%; p = 0.8) or requirement for other immunosuppressive therapy (56% vs. 54%; p = 0.8). The total prednisolone dose received following completion of study medication was 5475 mg vs. 6674 mg ( p = 0.07). SAE rates were not significantly different (25% vs. 17%; p = 0.1) and neither were AEs, except poor behaviour (yes/no), which was less frequent with EC treatment. There were no differences in ACBC scores. EC therapy was associated with a mean increase in generic health benefit [0.0162 additional quality-adjusted life-years (QALYs)] and cost savings (£4369 vs. £2696).
LIMITATIONS
Study drug formulation may have prevented some younger children who were unable to swallow whole or crushed tablets from participating.
CONCLUSIONS
This trial has not shown any clinical benefit for EC prednisolone therapy in UK children. The cost-effectiveness analysis suggested that EC therapy may be cheaper, with the possibility of a small QALY benefit.
FUTURE WORK
Studies investigating EC versus SC therapy in younger children and further cost-effectiveness analyses are warranted.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN16645249 and EudraCT 2010-022489-29.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 26. See the NIHR Journals Library website for further project information.",2019,"SAE rates were not significantly different (25% vs. 17%; p = 0.1) and neither were AEs, except poor behaviour (yes/no), which was less frequent with EC treatment.","['Participants aged between 1 and 15 years', 'younger children', 'mg vs. 6674', 'UK children', 'childhood nephrotic syndrome', 'Two hundred and thirty-seven children presenting with a first episode of SSNS', 'One hundred and twenty-five UK paediatric departments', 'younger children who were unable to swallow whole or crushed tablets from participating']","['placebo', 'EC therapy', 'standard course (SC) prednisolone therapy: 60\u2009mg/m 2 /day of prednisolone', 'extended course (EC) prednisolone therapy: 60\u2009mg/m 2 /day of prednisolone', 'minimisation algorithm to ensure balance of ethnicity (South Asian, white or other) and age (≤\u20095 or ≥\u20096 years', 'prednisolone therapy', 'prednisolone', 'EC prednisolone therapy']","['relapse rate, incidence of FRNS and SDNS, other immunosuppressive therapy use, rates of serious adverse events (SAEs) and AEs and the incidence of behavioural change [using Achenbach Child Behaviour Checklist (ACBC', 'ACBC scores', 'SDNS', 'incidence of FRNS', 'generic health benefit', 'time to first relapse', 'SAE rates', 'cost savings', 'time to first relapse [Albustix ® (Siemens Healthcare Limited, Frimley, UK)-positive proteinuria +++ or greater for 3 consecutive days or the presence of generalised oedema plus +++ proteinuria', 'relapse rate, FRNS and steroid-dependent nephrotic syndrome (SDNS) rates, requirement for alternative immunosuppressive agents and corticosteroid-related adverse events (AEs), including adverse behaviour and costs']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3874381', 'cui_str': 'Childhood nephrotic syndrome (disorder)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department (environment)'}, {'cui': 'C4048182', 'cui_str': 'Unable to swallow (finding)'}, {'cui': 'C0185060', 'cui_str': 'Crushing - action (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0002045'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C2724205', 'cui_str': '+++'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0151603', 'cui_str': 'Anasarca'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome (disorder)'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",237.0,0.513398,"SAE rates were not significantly different (25% vs. 17%; p = 0.1) and neither were AEs, except poor behaviour (yes/no), which was less frequent with EC treatment.","[{'ForeName': 'Nicholas Ja', 'Initials': 'NJ', 'LastName': 'Webb', 'Affiliation': ""Department of Paediatric Nephrology, University of Manchester, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Woolley', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tosin', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Brettell', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Emma N', 'Initials': 'EN', 'LastName': 'Barsoum', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Trompeter', 'Affiliation': 'Centre for Nephrology, University College London, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Cummins', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23260']
1220,31152658,The Degree of Aminoacidemia after Dairy Protein Ingestion Does Not Modulate the Postexercise Anabolic Response in Young Men: A Randomized Controlled Trial.,"BACKGROUND
Resistance exercise and dietary protein stimulate muscle protein synthesis (MPS). The rate at which proteins are digested and absorbed into circulation alters peak plasma amino acid concentrations and may modulate postexercise MPS. A novel mineral modified milk protein concentrate (mMPC), with identical amino acid composition to standard milk protein concentrate (MPC), was formulated to induce rapid aminoacidemia.
OBJECTIVES
The aim of this study was to determine whether rapid aminoacidemia and greater peak essential amino acid (EAA) concentrations induced by mMPC would stimulate greater postresistance exercise MPS, anabolic signaling, and ribosome biogenesis compared to standard dairy proteins, which induce a small but sustained plasma essential aminoacidemia.
METHODS
Thirty healthy young men (22.5 ± 3.0 y; BMI 23.8 ± 2.7 kg/m2) received primed constant infusions of l-[ring-13C6]-phenylalanine and completed 3 sets of leg presses and leg extensions at 80% of 1 repetition. Afterwards, participants were randomly assigned in a double-blind fashion to consume 25 g mMPC, MPC, or calcium caseinate (CAS). Vastus lateralis biopsies were collected at rest, and 2 and 4 h post exercise.
RESULTS
Plasma EAA concentrations, including leucine, were 19.2-26.6% greater in the mMPC group 45-90 min post ingestion than in MPC and CAS groups (P < 0.001). Myofibrillar fractional synthetic rate from baseline to 4 h was increased by 82.6 ± 64.8%, 137.8 ± 72.1%, and 140.6 ± 52.4% in the MPC, mMPC, and CAS groups, respectively, with no difference between groups (P = 0.548). Phosphorylation of anabolic signaling targets (P70S6KThr389, P70S6KThr421/Ser424, RPS6Ser235/236, RPS6Ser240/244, P90RSKSer380, 4EBP1) were elevated by <3-fold at both 2 and 4 h post exercise in all groups (P < 0.05).
CONCLUSIONS
The amplitude of plasma leucine and EAA concentrations does not modulate the anabolic response to resistance exercise after ingestion of 25 g dairy protein in young men. This trial was registered at http://www.anzctr.org.au/ as ACTRN12617000393358.",2019,The amplitude of plasma leucine and EAA concentrations does not modulate the anabolic response to resistance exercise after ingestion of 25 g dairy protein in young men.,"['Young Men', 'young men', 'Thirty healthy young men (22.5\xa0±']","['primed constant infusions of l-[ring-13C6]-phenylalanine', 'double-blind fashion to consume 25 g mMPC, MPC, or calcium caseinate (CAS', 'Resistance exercise and dietary protein', 'novel mineral modified milk protein concentrate (mMPC), with identical amino acid composition to standard milk protein concentrate (MPC', 'mMPC']","['Plasma EAA concentrations, including leucine', 'Myofibrillar fractional synthetic rate', 'Degree of Aminoacidemia after Dairy Protein Ingestion', 'Postexercise Anabolic Response']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0456638', 'cui_str': '25G (qualifier value)'}, {'cui': 'C0639214', 'cui_str': 'MMPC'}, {'cui': 'C0301465', 'cui_str': 'Calcium caseinate (substance)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0268457', 'cui_str': 'Aminoacidemia'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",30.0,0.312324,The amplitude of plasma leucine and EAA concentrations does not modulate the anabolic response to resistance exercise after ingestion of 25 g dairy protein in young men.,"[{'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Chan', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Randall F', 'Initials': 'RF', 'LastName': ""D'Souza"", 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Beals', 'Affiliation': 'Division of Nutritional Sciences.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zeng', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Utpal', 'Initials': 'U', 'LastName': 'Prodhan', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Fanning', 'Affiliation': 'Fonterra Research and Development Centre, Palmerston North, New Zealand.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Roy J. Carver Biotechnology Center.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Division of Nutritional Sciences.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'Liggins Institute.'}, {'ForeName': 'Cameron J', 'Initials': 'CJ', 'LastName': 'Mitchell', 'Affiliation': 'Liggins Institute.'}]",The Journal of nutrition,['10.1093/jn/nxz099']
1221,30926571,Home Visiting and Antenatal Depression Affect the Quality of Mother and Child Interactions in South Africa.,"OBJECTIVE
To examine whether maternal depressed mood at birth moderated the protective effect of a home-visiting intervention on the quality of caregiving for children growing up in a low- and middle-income country.
METHOD
Almost all pregnant mothers in 24 Cape Town neighborhoods were recruited into a cluster randomized controlled trial matched by neighborhoods to the Philani home-visiting condition (HVC) or the standard care condition (SC). At 3 years after birth, the quality of mother-child interactions between HVC and SC mothers with and without antenatal depressed mood was assessed in a representative subset by rating videotaped observations of mother-child interactions on 10 dimensions of caregiving.
RESULTS
As predicted, maternal depressed mood at birth moderated the effect of the HVC on the quality of mother-child interactions. Among nondepressed mothers, mothers and their children in the HVC scored significantly higher on 5 of the 10 dimensions of the maternal-child interaction scale than mothers in the SC: mothers exhibited more maternal sensitivity, talked more, had more harmonious interactions, and had children who paid more attention and exhibited more positive affect. However, being in the HVC did not significantly affect the mother-child interaction scores among mothers with depressed mood. Among HVC children, those with mothers with depressed mood showed significantly less positive affect and talked less with their mothers than children with nondepressed mothers. SC children with mothers with depressed mood were more responsive and paid attention to their mothers than children with nondepressed mothers.
CONCLUSION
Home visiting resulted in a better quality of caregiving for mothers without depressive symptoms. Future interventions need to specifically target maternal depression and positive mother-child interactions.
CLINICAL TRIAL REGISTRATION INFORMATION
Mentor Mothers: A Sustainable Family Intervention in South African Townships; https://clinicaltrials.gov; NCT00972699; Philani Home-based Nutrition Intervention Program; https://clinicaltrials.gov; NCT00995592.",2019,"SC children with mothers with depressed mood were more responsive and paid attention to their mothers than children with nondepressed mothers.
","['South Africa', 'pregnant mothers in 24 Cape Town neighborhoods', 'children growing up in a low- and middle-income country', 'Mentor Mothers', 'SC children with mothers with depressed mood', 'mothers without depressive symptoms']","['HVC', 'neighborhoods to the Philani home-visiting condition (HVC) or the standard care condition (SC', 'home-visiting intervention']","['maternal sensitivity', 'quality of mother-child interactions', 'quality of caregiving', 'maternal-child interaction scale', 'Quality of Mother and Child Interactions', 'mother-child interaction scores']","[{'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0396728,"SC children with mothers with depressed mood were more responsive and paid attention to their mothers than children with nondepressed mothers.
","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Christodoulou', 'Affiliation': 'Semel Institute, University of California-Los Angeles. Electronic address: jchristodoulou@mednet.ucla.edu.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Semel Institute, University of California-Los Angeles.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Bradley', 'Affiliation': 'Institute for Life Course Health Research, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Stellenbosch University, Stellenbosch, South Africa; School of Nursing and Midwifery, Queens University, Belfast, UK.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.03.016']
1222,31750855,Effect of Supplementation With Marine ω-3 Fatty Acid on Risk of Colorectal Adenomas and Serrated Polyps in the US General Population: A Prespecified Ancillary Study of a Randomized Clinical Trial.,"Importance
Marine ω-3 fatty acid has been suggested to protect against colorectal cancer.
Objective
To assess the effect of daily marine ω-3 fatty acid supplementation on the risk of colorectal cancer precursors, including conventional adenomas and serrated polyps.
Design, Setting, and Participants
This study was a prespecified ancillary study of the placebo-controlled randomized clinical trial VITAL (Vitamin D and Omega-3 Trial). An intention-to-treat analysis was used to examine the effect of daily marine ω-3 supplements among 25 871 adults in the US general population (including 5106 African American persons) free of cancer and cardiovascular disease at enrollment. Randomization was from November 2011 to March 2014, and intervention ended as planned on December 31, 2017.
Interventions
Marine ω-3 fatty acid, 1 g daily (which included eicosapentaenoic acid, 460 mg, and docosahexaenoic acid, 380 mg) and vitamin D3 (2000 IU daily) supplements.
Main Outcomes and Measures
Risk of conventional adenomas (including tubular adenoma, tubulovillous adenoma, villous adenoma, and adenoma with high-grade dysplasia) or serrated polyps (including hyperplastic polyp, traditional serrated adenoma, and sessile serrated polyp). In a subset of participants who reported receiving a diagnosis of polyp on follow-up questionnaires, endoscopic and pathologic records were obtained to confirm the diagnosis. Odds ratios (ORs) and 95% CIs were calculated using logistic regression, after adjusting for age, sex, vitamin D treatment assignment, and use of endoscopy. Secondary analyses were performed according to polyp features and participants' characteristics.
Results
The demographic characteristics of participants at randomization were well balanced between the treatment and placebo groups; for example, 50.6% vs 50.5% were women, and 19.7% vs 19.8% were African American persons were included in each group. The mean (SD) age was 67.1 (7.1) years in the placebo group and 67.2 (7.1) in the ω-3 treatment group. During a median follow-up of 5.3 years (range, 3.8-6.1 years), 294 cases of conventional adenomas were documented in the ω-3 group and 301 in the control group (multivariable OR, 0.98; 95% CI, 0.83-1.15) (1:1 ratio between number of cases and number of participants). In addition, 174 cases of serrated polyps were documented in the ω-3 group and 167 in the control group (OR, 1.05; 95% CI, 0.84-1.29). Null associations were found for polyp subgroups according to size, location, multiplicity, or histology. In secondary analyses, marine ω-3 treatment appeared to be associated with lower risk of conventional adenomas among individuals with low plasma levels of ω-3 index at baseline (OR, 0.76; 95% CI, 0.57-1.02; P = .03 for interaction by ω-3 index). A beneficial association of supplementation was also noted in the African American population (OR, 0.59; 95% CI, 0.35-1.00) but not in other racial/ethnic groups (P = .11 for interaction).
Conclusions and Relevance
Supplementation with marine ω-3 fatty acids, 1 g per day, was not associated with reduced risk of colorectal cancer precursors. A potential benefit of this supplementation for individuals with low baseline ω-3 levels or for African American persons requires further confirmation.
Trial Registration
ClinicalTrials.gov identifier: NCT01169259.",2019,"A beneficial association of supplementation was also noted in the African American population (OR, 0.59; 95% CI, 0.35-1.00) but not in other racial/ethnic groups (P = .11 for interaction).
","['groups; for example, 50.6% vs 50.5% were women, and 19.7% vs 19.8% were African American persons', '25\u202f871 adults in the US general population (including 5106 African American persons) free of cancer and cardiovascular disease at enrollment', 'individuals with low baseline ω-3 levels or for African American persons', 'Colorectal Adenomas and Serrated Polyps in the US General Population']","['fatty acid, 1 g daily (which included eicosapentaenoic acid, 460 mg, and docosahexaenoic acid, 380 mg) and vitamin D3', 'daily marine ω-3 supplements', 'daily marine ω-3 fatty acid supplementation', 'placebo', 'Supplementation With Marine ω-3 Fatty Acid']","['Measures\n\n\nRisk of conventional adenomas (including tubular adenoma, tubulovillous adenoma, villous adenoma, and adenoma with high-grade dysplasia) or serrated polyps (including hyperplastic polyp, traditional serrated adenoma, and sessile serrated polyp', 'Odds ratios (ORs']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0334292', 'cui_str': 'Tubular adenoma, no International Classification of Diseases for Oncology subtype (morphologic abnormality)'}, {'cui': 'C0334307', 'cui_str': 'Tubulovillous adenoma (morphologic abnormality)'}, {'cui': 'C0206674', 'cui_str': 'Adenoma, Villous'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C0333983', 'cui_str': 'Metaplastic polyp (morphologic abnormality)'}, {'cui': 'C1266025', 'cui_str': 'Serrated adenoma'}, {'cui': 'C2732618', 'cui_str': 'Sessile serrated polyp'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",294.0,0.377871,"A beneficial association of supplementation was also noted in the African American population (OR, 0.59; 95% CI, 0.35-1.00) but not in other racial/ethnic groups (P = .11 for interaction).
","[{'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Dushkes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Mongan Institute, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Ogino', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2019.4587']
1223,30914500,n-3 PUFAs improve erythrocyte fatty acid profile in patients with small AAA: a randomized controlled trial.,"Abdominal aortic aneurysm (AAA) is an important cause of death in older adults, which has no current drug therapy. Inflammation and abnormal redox status are believed to be key pathogenic mechanisms for AAA. In light of evidence correlating inflammation with aberrant fatty acid profiles, this study compared erythrocyte fatty acid content in 43 AAA patients (diameter 3.0-4.5 cm) and 52 healthy controls. In addition, the effect of omega-3 PUFA (n-3 PUFA) supplementation on erythrocyte fatty acid content was examined in a cohort of 30 AAA patients as part of a 12 week randomized placebo-controlled clinical trial. Blood analyses identified associations between AAA and decreased linoleic acid (LA), and AAA and increased Δ6-desaturase activity and biosynthesis of arachidonic acid (AA) from LA. Omega-3 PUFA supplementation (1.5 g DHA + 0.3 g EPA/day) decreased red blood cell distribution width (14.8 ± 0.4% to 13.8 ± 0.2%; P = 0.003) and levels of pro-inflammatory n-6 PUFAs (AA, 12.46 ± 0.23% to 10.14 ± 0.3%, P < 0.001; adrenic acid, 2.12 ± 0.13% to 1.23 ± 0.09%; P < 0.001). In addition, Δ-4 desaturase activity increased (DHA/docosapentaenoic acid ratio, 1.85 ± 0.14 to 3.93 ± 0.17; P < 0.001) and elongase 2/5 activity decreased (adrenic acid/AA ratio, 0.17 ± 0.01 to 0.12 ± 0.01; P < 0.01) following supplementation. The findings suggest that n-3 PUFAs improve fatty acid profiles and ameliorate factors associated with inflammation in AAA patients.",2019,"In addition, Δ-4 desaturase activity increased (DHA/docosapentaenoic acid ratio, 1.85 ± 0.14 to 3.93 ± 0.17; P < 0.001) and elongase 2/5 activity decreased (adrenic acid/AA ratio, 0.17 ± 0.01 to 0.12 ± 0.01; P < 0.01) following supplementation.","['43 AAA patients (diameter 3.0-4.5 cm) and 52 healthy controls', 'patients with small AAA', 'older adults']","['Abdominal aortic aneurysm (AAA', 'n-3 PUFAs', 'omega-3 PUFA (n-3 PUFA) supplementation', 'placebo']","['linoleic acid (LA), and AAA and increased Δ6-desaturase activity and biosynthesis of arachidonic acid (AA', 'erythrocyte fatty acid profile', 'red blood cell distribution width', 'levels of pro-inflammatory n-6 PUFAs', 'erythrocyte fatty acid content', 'Δ-4 desaturase activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0162871', 'cui_str': 'Aortic Aneurysm, Abdominal'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",30.0,0.112601,"In addition, Δ-4 desaturase activity increased (DHA/docosapentaenoic acid ratio, 1.85 ± 0.14 to 3.93 ± 0.17; P < 0.001) and elongase 2/5 activity decreased (adrenic acid/AA ratio, 0.17 ± 0.01 to 0.12 ± 0.01; P < 0.01) following supplementation.","[{'ForeName': 'Lara T', 'Initials': 'LT', 'LastName': 'Meital', 'Affiliation': 'GeneCology Research Centre, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Windsor', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Rebecca M L', 'Initials': 'RML', 'LastName': 'Ramirez Jewell', 'Affiliation': 'GeneCology Research Centre, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Technical Services University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schulze', 'Affiliation': 'Sunshine Vascular, Buderim, Queensland, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Magee', 'Affiliation': 'Sunshine Coast University Hospital Birtinya, Queensland, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': ""O'Donnell"", 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Jha', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Perissiou', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golledge', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease College of Medicine and Dentistry, James Cook University and Department of Vascular and Endovascular Surgery, Townsville Hospital, Townsville, Australia; and.'}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Bailey', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brooks', 'Affiliation': 'Centre for Genetics, Ecology, and Physiology, School of Science and Engineering University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Askew', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Fraser D', 'Initials': 'FD', 'LastName': 'Russell', 'Affiliation': 'GeneCology Research Centre, University of the Sunshine Coast, Queensland, Australia frussell@usc.edu.au.'}]",Journal of lipid research,['10.1194/jlr.P093013']
1224,28082323,Second Generation Electronic Nicotine Delivery System Vape Pen Exposure Generalizes as a Smoking Cue.,"Introduction
Second generation electronic nicotine delivery systems (ENDS; also known as e-cigarettes, vaporizers or vape pens) are designed for a customized nicotine delivery experience and have less resemblance to regular cigarettes than first generation ""cigalikes."" The present study examined whether they generalize as a conditioned cue and evoke smoking urges or behavior in persons exposed to their use.
Methods
Data were analyzed in N = 108 young adult smokers (≥5 cigarettes per week) randomized to either a traditional combustible cigarette smoking cue or a second generation ENDS vaping cue in a controlled laboratory setting. Cigarette and e-cigarette urge and desire were assessed pre- and post-cue exposure. Smoking behavior was also explored in a subsample undergoing a smoking latency phase after cue exposure (N = 26).
Results
The ENDS vape pen cue evoked both urge and desire for a regular cigarette to a similar extent as that produced by the combustible cigarette cue. Both cues produced similar time to initiate smoking during the smoking latency phase. The ENDS vape pen cue elicited smoking urge and desire regardless of ENDS use history, that is, across ENDS naїve, lifetime or current users. Inclusion of past ENDS or cigarette use as covariates did not significantly alter the results.
Conclusions
These findings demonstrate that observation of vape pen ENDS use generalizes as a conditioned cue to produce smoking urge, desire, and behavior in young adult smokers. As the popularity of these devices may eventually overtake those of first generation ENDS cigalikes, exposure effects will be of increasing importance.
Implications
This study shows that passive exposure to a second generation ENDS vape pen cue evoked smoking urge, desire, and behavior across a range of daily and non-daily young adult smokers. Smoking urge and desire increases after vape pen exposure were similar to those produced by exposure to a first generation ENDS cigalike and a combustible cigarette, a known potent cue. Given the increasing popularity of ENDS tank system products, passive exposures to these devices will no doubt increase, and may contribute to tobacco use in young adult smokers.",2018,"Smoking urge and desire increases after vape pen exposure were similar to those produced by exposure to a first generation ENDS cigalike and a combustible cigarette, a known potent cue.","['young adult smokers', 'subsample undergoing a smoking latency phase after cue exposure (N = 26', '108 young adult smokers (≥5 cigarettes per week) randomized to either a']","['Introduction\n\n\nSecond generation electronic nicotine delivery systems (ENDS', 'traditional combustible cigarette smoking cue or a second generation ENDS vaping cue']","['Cigarette and e-cigarette urge and desire', 'Smoking behavior']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}]",108.0,0.00981272,"Smoking urge and desire increases after vape pen exposure were similar to those produced by exposure to a first generation ENDS cigalike and a combustible cigarette, a known potent cue.","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago IL.'}, {'ForeName': 'Lia J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago IL.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago IL.'}, {'ForeName': 'Dingcai', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago IL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntw327']
1225,31147972,Intravenous Dexmedetomidine Combined with Ultrasound-Guided Rectus Sheath Block for Open Gastrectomy: a Prospective Randomized Trial.,"PURPOSE
To compare the incidences of positive hemodynamic response (HR > 100 beats min -1 or SBP > 160 mmHg) during abdominal exploration and moderate pain after surgery, when using dexmedetomidine infusion and rectus sheath block.
METHODS
One hundred patients undergoing open gastrectomy were randomized to receive rectus sheath block with ropivacaine (Group B, n = 25), initial loading dose of 0.6 μg kg -1 dexmedetomidine, followed by a continuous infusion of 0.2 μg kg -1 h -1 throughout surgery (Group D, n = 25), both rectus sheath block and dexmedetomidine (Group BD, n = 25), or neither rectus sheath block nor dexmedetomidine (Group C, n = 25). General anesthesia techniques were standardized. HR, SBP, and positive hemodynamic response at peritoneum incision (T PI ), 5 min (T AE-5 ), 10 min (T AE-10 ), and 15 min (T AE-15 ) after the start of abdominal exploration, and incidences of moderate postoperative pain were recorded.
RESULTS
Positive hemodynamic responses during abdominal exploration were more common in Groups B (82%) and C (74%) than in Groups D (14%) and BD (9%) (all P = 0.000). HR and SBP were lower in Groups D and BD, compared with those in Groups C and B (all P < 0.05). Compared with T PI , HR and SBP increased significantly in Groups B and C during abdominal exploration (all P < 0.05) , but not in Group BD (except HR at T AE-15 ). The incidences of moderate pain in Groups B and BD were noticeably lower than in Groups C and D at 1 h, 2 h, and 6 h after surgery (all P < 0.0083).
CONCLUSION
Dexmedetomidine infusion combined with rectus sheath block provided more hemodynamic stability during abdominal exploration and better analgesia after surgery.",2020,"RESULTS
Positive hemodynamic responses during abdominal exploration were more common in Groups B (82%) and C (74%) than in Groups D (14%) and BD (9%)","['One hundred patients undergoing open gastrectomy', 'Open Gastrectomy']","['initial loading dose of 0.6\xa0μg\xa0kg -1 dexmedetomidine, followed by a continuous infusion of 0.2\xa0μg', 'rectus sheath block and dexmedetomidine', 'Dexmedetomidine infusion combined with rectus sheath block', '1 \xa0h -1 throughout surgery ', 'Dexmedetomidine Combined with Ultrasound-Guided Rectus Sheath Block', 'rectus sheath block nor dexmedetomidine', 'dexmedetomidine infusion and rectus sheath block', 'rectus sheath block with ropivacaine']","['positive hemodynamic response', 'HR, SBP, and positive hemodynamic response at peritoneum incision (T PI ), 5\xa0min (T AE-5 ), 10\xa0min (T AE-10 ), and 15\xa0min (T AE-15 ', 'moderate postoperative pain', 'T PI , HR and SBP', 'hemodynamic stability', 'moderate pain', 'HR and SBP']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}]",100.0,0.0376066,"RESULTS
Positive hemodynamic responses during abdominal exploration were more common in Groups B (82%) and C (74%) than in Groups D (14%) and BD (9%)","[{'ForeName': 'Yonghua', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Jiafeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Changhai Hospital, Second Military Medical University, No. 168 Changhai Road, Shanghai, 200433, China.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, No.225 Changhai Road, Shanghai, 200433, China. miaoxuerongdr@126.com.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai, 200003, China. jfjczyy@aliyun.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04249-2']
1226,31026713,Increasing substance use disorder counselors' self-efficacy and skills in talking to patients about sex and HIV risk: A randomized training trial.,"BACKGROUND
People with substance use disorder (SUD) experience increased risk for HIV, Hepatitis C, and sexually transmitted illnesses via risky sex. This high-risk population would benefit from sexual risk reduction interventions integrated into SUD treatment. However, many SUD counselors report lack of skill or confidence in addressing sexual risk with patients.
METHODS
This study was part of a larger nested 2 × 2 factorial repeated measures design, which compared two levels of counselor training (Basic-2 h versus Enhanced-10 h plus ongoing coaching). We determined whether counselors receiving Enhanced training addressing their motivation, confidence and skills (a) increased knowledge about sexual issues; (b) increased self-efficacy to discuss sex with patients; and (c) improved skills in discussing sex as part of SUD treatment, compared with those receiving shorter information-based training. Counselors providing individual therapy at two opioid treatment programs (OTP) and two psychosocial outpatient programs in the United States were eligible. Randomization occurred after Basic training. Measures included self-report (self-efficacy and knowledge) and blinded coding of standardized patient interviews (skill).
RESULTS
Counselors receiving Enhanced training (n = 28) showed significant improvements compared to their Basic training counterparts (n = 32) in self-efficacy, use of reflections, and use of decision-making and communication strategies with standardized patients. These improvements were maintained from post-training to 3-month follow-up. No adverse effects of study participation were reported.
CONCLUSIONS
Results suggest that counselors can improve their knowledge, self-efficacy and skill related to sexual risk conversations with patients based on modest skills-based training.",2019,"We determined whether counselors receiving Enhanced training addressing their motivation, confidence and skills (a) increased knowledge about sexual issues; (b) increased self-efficacy to discuss sex with patients; and (c) improved skills in discussing sex as part of SUD treatment, compared with those receiving shorter information-based training.","['Counselors providing individual therapy at two opioid treatment programs (OTP) and two psychosocial outpatient programs in the United States were eligible', 'People with substance use disorder (SUD) experience increased risk for HIV, Hepatitis C, and sexually transmitted illnesses via risky sex', 'patients about sex and HIV risk']",['counselor training (Basic-2\u2009h versus Enhanced-10\u2009h plus ongoing coaching'],"['self-report (self-efficacy and knowledge) and blinded coding of standardized patient interviews (skill', 'knowledge, self-efficacy and skill related to sexual risk conversations', 'self-efficacy, use of reflections, and use of decision-making and communication strategies', 'knowledge about sexual issues; (b) increased self-efficacy']","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0180655,"We determined whether counselors receiving Enhanced training addressing their motivation, confidence and skills (a) increased knowledge about sexual issues; (b) increased self-efficacy to discuss sex with patients; and (c) improved skills in discussing sex as part of SUD treatment, compared with those receiving shorter information-based training.","[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Hatch-Maillette', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA; Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 1959 NE Pacific St., Seattle, WA, 98105, USA. Electronic address: hatchm@uw.edu.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Harwick', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Baer', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA; VA Puget Sound Healthcare System-Seattle Division, 1660 S. Columbian Way, Seattle, WA, 98108, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Wells', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA; Emeritus, University of Washington School of Social Work, 4101 15th Ave NE, Seattle, WA, 98105, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Masters', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA.'}, {'ForeName': 'Audra', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychology, University of Washington, 119A Guthrie Hall Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Kasie', 'Initials': 'K', 'LastName': 'Cloud', 'Affiliation': 'CODA, Inc., 1027 E. Burnside St., Portland, OR, 97214, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Peavy', 'Affiliation': 'Evergreen Treatment Services, 1700 Airport Way South, Seattle, WA, 98134, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wiest', 'Affiliation': 'CODA, Inc., 1027 E. Burnside St., Portland, OR, 97214, USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dillon', 'Affiliation': 'CODA, Inc., 1027 E. Burnside St., Portland, OR, 97214, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Beadnell', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.02.023']
1227,31130760,A Double-Blind Placebo Controlled Study of Intranasal Oxytocin's Effect on Emotion Recognition and Visual Attention in Outpatients with Emotional Disorders.,"The current study used double-blind, placebo-controlled design to examine the effect of intranasal oxytocin (OT) on emotion recognition (ER) and visual attention in 60 outpatients presenting for assessment and treatment of emotional disorders. Our primary hypothesis was that OT would improve recognition of happy faces in depressed participants. The main effect of OT on ER accuracy, speed, and proportion of fixations in the eye region was not significant. Diagnostic group (i.e., presence/absence of a depressive disorder) moderated the effect of OT on ER, but not as expected: OT significantly slowed ER speed for all emotions in participants with anxiety disorders, but did not affect performance in participants with depressive disorders. Depressed participants fixated significantly less in the eye region of sad faces than anxious participants. Before OT can be used to target ER biases, additional research is needed to explicate the differential impact of OT on ER speed in patients with anxiety versus mood disorders.",2019,"The main effect of OT on ER accuracy, speed, and proportion of fixations in the eye region was not significant.","['participants with depressive disorders', '60 outpatients presenting for assessment and treatment of emotional disorders', 'Outpatients with Emotional Disorders', 'participants with anxiety disorders', 'patients with anxiety versus mood disorders']","['OT', 'placebo', 'Placebo', ""Intranasal Oxytocin's"", 'intranasal oxytocin (OT']","['Emotion Recognition and Visual Attention', 'recognition of happy faces', 'ER accuracy, speed, and proportion of fixations in the eye region', 'emotion recognition (ER) and visual attention']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",60.0,0.197971,"The main effect of OT on ER accuracy, speed, and proportion of fixations in the eye region was not significant.","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Rutter', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, 648 Beacon Street, 6 Floor, Boston, MA 02215.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Norton', 'Affiliation': 'Williams College, 880 Main Street, Williamstown, MA 01267.'}, {'ForeName': 'Bonnie S', 'Initials': 'BS', 'LastName': 'Brown', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, 648 Beacon Street, 6 Floor, Boston, MA 02215.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Brown', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, 648 Beacon Street, 6 Floor, Boston, MA 02215.'}]",Cognitive therapy and research,['10.1007/s10608-018-9974-x']
1228,31748939,A Latent Class Analysis of HIV Risk Factors Among Men and Women with Opioid Use Disorder in Pre-trial Detention.,"Adults entering pre-trial detention who inject drugs are at high risk for acquiring HIV/AIDS. In the current study, we examined pre-incarceration HIV risk behaviors among 114 people with opioid use disorder who inject drugs. Participants were recruited from the Baltimore City Detention Center as part of a randomized controlled trial of pre-release methadone treatment. Using latent class analysis, we found three separate latent classes, which we identified as the sex exchange class (14.2%), drug equipment sharing class (36.8%) and lower risk class (49.0%). Women in the sex exchange class (n = 16) reported having multiple male partners and selling sex for money or drugs; however, this group also reported more consistent condom use and less frequent injection drug and equipment sharing than participants in the drug equipment sharing class. Our findings highlight distinct profiles of jail detainees with OUD based on their risks for HIV, and could inform more targeted interventions for each group.Clinical Trials Registration: Clinicaltrials.gov NCT02334215.",2020,"Women in the sex exchange class (n = 16) reported having multiple male partners and selling sex for money or drugs; however, this group also reported more consistent condom use and less frequent injection drug and equipment sharing than participants in the drug equipment sharing class.","['Adults entering pre-trial detention who inject drugs are at high risk for acquiring HIV/AIDS', '114 people with opioid use disorder who inject drugs', 'Men and Women with Opioid Use Disorder in Pre-trial Detention', 'Participants were recruited from the Baltimore City Detention Center as part of a randomized controlled trial of pre-release']",['methadone treatment'],['HIV Risk Factors'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",114.0,0.105735,"Women in the sex exchange class (n = 16) reported having multiple male partners and selling sex for money or drugs; however, this group also reported more consistent condom use and less frequent injection drug and equipment sharing than participants in the drug equipment sharing class.","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA. mmitchell@friendsresearch.org.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Monico', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02726-y']
1229,30817366,"Effect of high-flow nasal cannula versus conventional facemask ventilation for patients undergoing modified electroconvulsive therapy: A randomised controlled, noninferiority trial.",,2019,,['patients undergoing modified electroconvulsive therapy'],['high-flow nasal cannula versus conventional facemask ventilation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]",[],,0.0691582,,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000000944']
1230,31157819,Evaluation of Economic and Clinical Outcomes Under Centers for Medicare & Medicaid Services Mandatory Bundled Payments for Joint Replacements.,"Importance
In 2016, the Centers for Medicare & Medicaid Services (CMS) launched its first mandatory bundled payment program, the Comprehensive Care for Joint Replacement (CJR) model, by randomizing metropolitan statistical areas (MSAs) into the payment model.
Objective
To evaluate changes in key economic and clinical outcomes associated with the CJR model.
Design, Setting, and Participants
A retrospective, national, population-based analysis of Medicare fee-for-service beneficiaries undergoing lower extremity joint replacement was conducted using 100% Medicare Part A data and 5% Medicare Part B data. Within an intention-to-treat framework, a difference-in-differences approach was used to compare Medicare spending, quality of care, volume of episodes, and patient selection in episodes of lower extremity joint replacements in the first 2 years of the program between propensity score-matched CJR and non-CJR hospitals (episodes initiated from April 1, 2016, through December 31, 2017, with the latter completed by March 31, 2018). Lower extremity joint replacement episodes in MSAs randomly assigned to the CJR model were compared with those in MSAs not assigned to the CJR model.
Exposures
Random assignment of MSAs into the CJR model within prespecified strata.
Main Outcomes and Measures
Spending and its components, quality of care, volume of episodes, and patient characteristics were the main outcomes.
Results
After propensity score matching, there were 157 828 primary lower extremity joint replacement cases across 684 hospitals in the CJR (treatment) group (101 641 [64.4%] women; mean [SD] age, 72.8 [8.9] years) and 180 594 cases across 726 hospitals in the non-CJR (control) group (115 580 women [64.0%] women; mean [SD] age, 72.6 [8.8] years). The CJR was associated with a decrease of $582 per episode in Medicare Part A spending, a 2.5% savings on claims (95% CI, -$873 to -$290; P < .001) driven by a 5.5% decline in 90-day postacute care spending, concentrated in skilled nursing facilities (-4.5% change from baseline; 95% CI, -$460 to -$26; P = .03) and inpatient rehabilitation facilities (-22.9% change from baseline; 95% CI,-$497 to -$176; P < .001). Estimated savings on claims, while consistent with changes in practice patterns, may not have exceeded the reconciliation payments to hospitals reported by CMS to date. No significant changes in hospital length of stay, readmissions, complications, 30- or 90-day mortality, volume of episodes, or patient characteristics relative to control were found.
Conclusions and Relevance
The CJR was associated with reduced Medicare Part A spending on claims over 2 years, largely through lower postacute spending. Mandatory bundled payments may serve as a useful model for policy efforts to change clinicians' and facilities' behavior without harming quality.",2019,"No significant changes in hospital length of stay, readmissions, complications, 30- or 90-day mortality, volume of episodes, or patient characteristics relative to control were found.
","['episodes of lower extremity joint replacements in the first 2 years of the program between propensity score-matched CJR and non-CJR hospitals (episodes initiated from April 1, 2016, through December 31, 2017, with the latter completed by March 31, 2018', '157\u202f828 primary lower extremity joint replacement cases across 684 hospitals in the CJR (treatment) group (101 641 [64.4%] women; mean [SD] age, 72.8 [8.9] years) and 180\u202f594 cases across 726 hospitals in the non-CJR (control) group (115 580 women [64.0%] women; mean [SD] age, 72.6 [8.8] years', 'Participants\n\n\nA retrospective, national, population-based analysis of Medicare fee-for-service beneficiaries undergoing lower extremity joint replacement was conducted using 100% Medicare Part A data and 5% Medicare Part B data']",[],"['skilled nursing facilities', 'Measures\n\n\nSpending and its components, quality of care, volume of episodes, and patient characteristics', 'inpatient rehabilitation facilities', 'hospital length of stay, readmissions, complications, 30- or 90-day mortality, volume of episodes, or patient characteristics relative to control', '90-day postacute care spending']","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0185317', 'cui_str': 'Joint Replacement'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0242816', 'cui_str': 'Fees for Service'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0079817', 'cui_str': 'Medicare Hospital Insurance Program'}, {'cui': 'C0079818', 'cui_str': 'SMI Program'}]",[],"[{'cui': 'C0037265', 'cui_str': 'Extended Care Facilities'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376635', 'cui_str': 'Post-acute Care'}]",,0.0653263,"No significant changes in hospital length of stay, readmissions, complications, 30- or 90-day mortality, volume of episodes, or patient characteristics relative to control were found.
","[{'ForeName': 'Derek A', 'Initials': 'DA', 'LastName': 'Haas', 'Affiliation': 'Avant-garde Health, Boston, Massachusetts.'}, {'ForeName': 'Xiaoran', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Avant-garde Health, Boston, Massachusetts.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kaplan', 'Affiliation': 'Harvard Business School, Boston, Massachusetts.'}, {'ForeName': 'Zirui', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0480']
1231,31122901,"Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial.","BACKGROUND
Atezolizumab (a monoclonal antibody against PD-L1), which restores anticancer immunity, improved overall survival in patients with previously treated non-small-cell lung cancer and also showed clinical benefit when combined with chemotherapy as first-line treatment of non-small-cell lung cancer. IMpower130 aimed to assess the efficacy and safety of atezolizumab plus chemotherapy versus chemotherapy alone as first-line therapy for non-squamous non-small-cell lung cancer.
METHODS
IMpower130 was a multicentre, randomised, open-label, phase 3 study done in 131 centres across eight countries (the USA, Canada, Belgium, France, Germany, Italy, Spain, and Israel). Eligible patients were aged 18 years or older, and had histologically or cytologically confirmed stage IV non-squamous non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0 or 1, and received no previous chemotherapy for stage IV disease. Patients were randomly assigned (2:1; permuted block [block size of six] with an interactive voice or web response system) to receive atezolizumab (1200 mg intravenously every 3 weeks) plus chemotherapy (carboplatin [area under the curve 6 mg/mL per min every 3 weeks] plus nab-paclitaxel [100 mg/m 2 intravenously every week]) or chemotherapy alone for four or six 21-day cycles followed by maintenance therapy. Stratification factors were sex, baseline liver metastases, and PD-L1 tumour expression. Co-primary endpoints were investigator-assessed progression-free survival and overall survival in the intention-to-treat wild-type (ie, EGFR wt and ALK wt ) population. The safety population included patients who received at least one dose of the study drug. This study is registered with ClinicalTrials.gov, number NCT02367781.
FINDINGS
Between April 16, 2015, and Feb 13, 2017, 724 patients were randomly assigned and 723 were included in the intention-to-treat population (one patient died before randomisation, but was assigned to a treatment group; this patient was excluded from the intention-to-treat population) of the atezolizumab plus chemotherapy group (483 patients in the intention-to-treat population and 451 patients in the intention-to-treat wild-type population) or the chemotherapy group (240 patients in the intention-to-treat population and 228 patients in the intention-to-treat wild-type population). Median follow-up in the intention-to-treat wild-type population was similar between groups (18·5 months [IQR 15·2-23·6] in the atezolizumab plus chemotherapy group and 19·2 months [15·4-23·0] in the chemotherapy group). In the intention-to-treat wild-type population, there were significant improvements in median overall survival (18·6 months [95% CI 16·0-21·2] in the atezolizumab plus chemotherapy group and 13·9 months [12·0-18·7] in the chemotherapy group; stratified hazard ratio [HR] 0·79 [95% CI 0·64-0·98]; p=0·033) and median progression-free survival (7·0 months [95% CI 6·2-7·3] in the atezolizumab plus chemotherapy group and 5·5 months [4·4-5·9] in the chemotherapy group; stratified HR 0·64 [95% CI 0·54-0·77]; p<0·0001]). The most common grade 3 or worse treatment-related adverse events were neutropenia (152 [32%] of 473 in the atezolizumab plus chemotherapy group vs 65 [28%] of 232 in the chemotherapy group), anaemia (138 [29%] vs 47 [20%]), and decreased neutrophil count (57 [12%] vs 19 [8%]). Treatment-related serious adverse events were reported in 112 (24%) of 473 patients in the atezolizumab plus chemotherapy group and 30 (13%) of 232 patients in the chemotherapy group. Treatment-related (any treatment) deaths occurred in eight (2%) of 473 patients in the atezolizumab plus chemotherapy group and one (<1%) of 232 patients in the chemotherapy group.
INTERPRETATION
IMpower130 showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations. No new safety signals were identified. This study supports the benefit of atezolizumab, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer.
FUNDING
F. Hoffmann-La Roche.",2019,"INTERPRETATION
IMpower130 showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations.","['patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations', 'Between April 16, 2015, and Feb 13, 2017', '724 patients were randomly assigned and 723 were included in the intention-to-treat population (one patient died before randomisation', 'Eligible patients were aged 18 years or older, and had histologically or cytologically confirmed stage IV non-squamous non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0 or 1, and received no previous chemotherapy for stage IV disease', '0·79', '131 centres across eight countries (the USA, Canada, Belgium, France, Germany, Italy, Spain, and Israel', 'patients with previously treated non-small-cell lung cancer', 'patients who received at least one dose of the study drug', 'metastatic non-squamous non-small-cell lung cancer (IMpower130', 'non-squamous non-small-cell lung cancer', 'group (240 patients in the intention-to-treat population and 228 patients in the intention-to-treat wild-type population']","['atezolizumab plus chemotherapy group (483 patients in the intention-to-treat population and 451 patients in the intention-to-treat wild-type population) or the chemotherapy', 'chemotherapy alone', 'chemotherapy (carboplatin [area under the curve 6 mg/mL per min every 3 weeks] plus nab-paclitaxel [100 mg/m 2 intravenously every week]) or chemotherapy alone', 'platinum-based chemotherapy', 'block [block size of six] with an interactive voice or web response system) to receive atezolizumab', 'carboplatin plus nab-paclitaxel chemotherapy', 'Atezolizumab', 'atezolizumab plus chemotherapy versus chemotherapy', 'atezolizumab', 'atezolizumab plus chemotherapy']","['hazard ratio [HR', 'anaemia', 'efficacy and safety', 'median progression-free survival', 'progression-free survival', 'investigator-assessed progression-free survival and overall survival', 'neutropenia', 'median overall survival', 'serious adverse events', 'overall survival', 'neutrophil count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517866', 'cui_str': 'Seven hundred and twenty-three'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",724.0,0.387435,"INTERPRETATION
IMpower130 showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations.","[{'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'West', 'Affiliation': 'Thoracic Oncology Program, Swedish Cancer Institute, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCleod', 'Affiliation': 'Sarah Cannon Research Institute, Florida Cancer Specialists, Fort Myers, FL, USA.'}, {'ForeName': 'Maen', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Sarah Cannon Research Institute, Florida Cancer Specialists, Leesburg, FL, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': 'Thoracic Medical Oncology, National Cancer Institute, IRCCS Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Rittmeyer', 'Affiliation': 'Department of Thoracic Oncology, Lungenfachklinik Immenhausen, Immenhausen, Germany.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Conter', 'Affiliation': 'Department of Medicine, William Osler Health System, Brampton, ON, Canada.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Robert Bosch Centrum für Tumorerkrankungen, Klinik Schillerhöhe, Stuttgart, Germany.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga, TN, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McCune', 'Affiliation': 'Northwest Georgia Oncology Centers, Marietta, GA, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Mekhail', 'Affiliation': 'Florida Hospital Cancer Institute, Orlando, FL, USA.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Zer', 'Affiliation': 'Thoracic Oncology Unit, Rabin Medical Center, Tel Aviv University, Petah-Tikva, Israel.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Thoracic Oncology, Asklepios Clinics Munich-Gauting, Gauting, Germany.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Sadiq', 'Affiliation': 'Fort Wayne Medical Oncology and Hematology, Fort Wayne, IN, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sandler', 'Affiliation': 'Clinical Science, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Clinical Science, Genentech, South San Francisco, CA, USA; Nektar Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Ochi Lohmann', 'Affiliation': 'PD Oncology, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Venice', 'Initials': 'V', 'LastName': 'Archer', 'Affiliation': 'PD Oncology, Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Lijia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kowanetz', 'Affiliation': 'Oncology Biomarker Development, Genentech, South San Francisco, CA, USA; Biotherapeutics, Inc., Redwood City, CA, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Cappuzzo', 'Affiliation': 'Department of Oncology and Hematology, AUSL Romagna, Ravenna, Italy. Electronic address: f.cappuzzo@gmail.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30167-6']
1232,31439501,Response of obese schoolchildren to high-intensity interval training applied in the school context.,"BACKGROUND
High-intensity interval training (HIIT) has been widely used to fight cardiovascular risk factors in adolescents and adults, but no data are available on its applicability in children.
OBJECTIVES
To assess the effects of HIIT on different anthropometric and cardiovascular parameters of overweight and obese children aged 7-9 years.
MATERIAL AND METHODS
Four groups were formed: 1) an overweight control group (OWCG, n=30, BMI=21.60±3.72kg/m 2 ); 2) an obesity control group (OCG, n=34, BMI=23.92±3.11kg/m 2 ); 3) an overweight intervention group (OWIG, n=69, BMI=20.01±1.88kg/m 2 ), and 4) an obesity intervention group (OIG, n=141, BMI=24.12±2.66kg/m 2 ). BMI, body fat (BF), waist circumference, height-waist ratio, systolic and diastolic blood pressure and cardiorespiratory fitness (CRF) were assessed before and after intervention.
RESULTS
There were significant differences in BMI (P<.001), BF (P<.001), and CRF (P<.001) between the groups (control vs. intervention) before and after intervention (OWCG vs. OWIG and OCG vs. OIG). BMI decreased in the OWIG (BMI, 20.01±1.88 at baseline vs. 19.00±2.02 after HIIT, P<.001) and OIG (BMI, 24.12±2.66 at baseline vs. 23.23±3.23 after HIIT, P<.001) groups. Similarly, BF decreased in the OWIG (BF, 21.84±4.97 at baseline vs. 19.55±4.81% after HIIT, P<.001) and OIG (BF, 30.26±11.49 at baseline vs. 26.81±6.80% after HIIT, P<.001) groups. CRF improved in both intervention groups (P<.001). There was a significant decrease in the prevalence rate of schoolchildren with obesity (from 66.4% to 49.6%) (P<.001).
CONCLUSION
The intervention conducted in the school setting improved the anthropometric and cardiovascular parameters of schoolchildren, and also allowed for reducing the proportion of schoolchildren with obesity.",2019,"There were significant differences in BMI (P<.001), BF (P<.001), and CRF (P<.001) between the groups (control vs. intervention) before and after intervention (OWCG vs. OWIG and OCG vs. OIG).","['Four groups were formed: 1) an', 'overweight and obese children aged 7-9 years', 'adolescents and adults', 'obese schoolchildren']","['overweight control group (OWCG', 'overweight intervention', 'HIIT', 'obesity control group (OCG', 'obesity intervention', 'High-intensity interval training (HIIT']","['BF', 'BMI', 'prevalence rate of schoolchildren with obesity', 'CRF', 'BMI (P<.001), BF (P<.001), and CRF', 'BMI, body fat (BF), waist circumference, height-waist ratio, systolic and diastolic blood pressure and cardiorespiratory fitness (CRF']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0261823,"There were significant differences in BMI (P<.001), BF (P<.001), and CRF (P<.001) between the groups (control vs. intervention) before and after intervention (OWCG vs. OWIG and OCG vs. OIG).","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Espinoza-Silva', 'Affiliation': 'Departamento de Educación Física, Deportes y Recreación, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Pedro Ángel', 'Initials': 'PÁ', 'LastName': 'Latorre-Román', 'Affiliation': 'Departamento de Didáctica de la Expresión Musical, Plástica y Corporal, Universidad de Jaén, Jaén, España.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Párraga-Montilla', 'Affiliation': 'Departamento de Didáctica de la Expresión Musical, Plástica y Corporal, Universidad de Jaén, Jaén, España.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Caamaño-Navarrete', 'Affiliation': 'Facultad de Educación, Universidad Católica de Temuco, Temuco, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jerez-Mayorga', 'Affiliation': 'Facultad de Ciencias de la Rehabilitación, Universidad Andrés Bello, Santiago, Chile.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Delgado-Floody', 'Affiliation': 'Departamento de Educación Física, Deportes y Recreación, Universidad de La Frontera, Temuco, Chile. Electronic address: pedro.delgado@ufrontera.cl.'}]","Endocrinologia, diabetes y nutricion",['10.1016/j.endinu.2019.05.005']
1233,31122158,Healthy Recovery: A Pilot Study of a Smoking and Other Health Behavior Change Intervention for People Attending Residential Alcohol and Other Substance Dependence Treatment.,"Objective: It is common for people attending alcohol and other substance dependence treatment to present with multiple unhealthy lifestyle behaviors such as high rates of smoking, physical inactivity, and poor diet. Healthy lifestyle interventions are increasing in importance in the general population, but have been underexamined within alcohol and other substance use populations. The purpose of the current study was to pilot ""Healthy Recovery,"" a group program that primarily aimed to help people attending alcohol or other substance dependence treatment to reduce or quit smoking. The program also encourages participants to increase physical activity and to eat more servings of fruit and vegetables. Methods: The current study was conducted as a non-randomized controlled pilot trial. All participants were attending residential substance dependence treatment provided by the Australian Salvation Army. In addition to treatment as usual, participants in the treatment condition completed Healthy Recovery ( n = 50) and participants in the control group completed an online depression program ( n = 27). The study examined the health outcomes of participants (i.e., smoking, physical activity, fruit and vegetable intake, and symptom distress) and the feasibility of running the group sessions within the residential facilities. Results: Within-treatment effects demonstrated medium to large positive effects for reductions in smoking and increases in physical activity, servings of fruit, and servings of vegetables for people completing Healthy Recovery. When compared to the control condition, there were medium effects in favor of the Healthy Recovery condition for reductions in smoking and increases in physical activity. There was a small effect for servings of fruit and no effect for servings of vegetables. Conclusions: Results from this study demonstrated that people attending residential substance dependence treatment are willing and capable of engaging in multiple health behavior change interventions.",2019,Results from this study demonstrated that people attending residential substance dependence treatment are willing and capable of engaging in multiple health behavior change interventions.,"['People Attending Residential Alcohol and Other Substance Dependence Treatment', 'Healthy Recovery', 'All participants were attending residential substance dependence treatment provided by the Australian Salvation Army', 'people attending alcohol or other substance dependence treatment to reduce or quit smoking']","['online depression program', 'Smoking and Other Health Behavior Change Intervention']","['physical activity and to eat more servings of fruit and vegetables', 'physical activity', 'physical activity, servings of fruit, and servings of vegetables', 'health outcomes of participants (i.e., smoking, physical activity, fruit and vegetable intake, and symptom distress']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0038580', 'cui_str': 'Substance Dependence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0018687'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",50.0,0.0275394,Results from this study demonstrated that people attending residential substance dependence treatment are willing and capable of engaging in multiple health behavior change interventions.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong , Wollongong , Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle , Callaghan , Australia.'}, {'ForeName': 'Camilla J', 'Initials': 'CJ', 'LastName': 'Townsend', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong , Wollongong , Australia.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Deane', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong , Wollongong , Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle , Wollongong , Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, Faculty of Health and Medicine, University of Newcastle , Wollongong , Australia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Ingram', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong , Wollongong , Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Keane', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong , Wollongong , Australia.'}, {'ForeName': 'Alison K', 'Initials': 'AK', 'LastName': 'Beck', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle , Callaghan , Australia.'}]",Journal of dual diagnosis,['10.1080/15504263.2019.1612537']
1234,31122494,"Dual antiplatelet therapy using cilostazol for secondary prevention in patients with high-risk ischaemic stroke in Japan: a multicentre, open-label, randomised controlled trial.","BACKGROUND
Although dual antiplatelet therapy with aspirin and clopidogrel reduces early recurrence of ischaemic stroke, with long-term use this type of therapy is no longer effective and the risk of bleeding increases. Given that cilostazol prevents stroke recurrence without increasing the incidence of serious bleeding compared with aspirin, we aimed to establish whether dual antiplatelet therapy involving cilostazol is safe and appropriate for long-term use.
METHODS
In a multicentre, open-label, randomised controlled trial across 292 hospitals in Japan, patients with high-risk non-cardioembolic ischaemic stroke identified on MRI were randomly assigned to two groups in a 1:1 ratio to receive monotherapy with either oral aspirin (81 or 100 mg, once per day) or clopidogrel (50 or 75 mg, once per day) alone, or a combination of cilostazol (100 mg, twice per day) with aspirin or clopidogrel. Randomisation was done centrally (using block randomisation with a block size of six per each participating hospital) through a web-based registration system and was done by EPS Corporation. The patients were required to have at least 50% stenosis of a major intracranial or extracranial artery or two or more of the vascular risk factors. Trial medication was continued for half a year or longer, for a maximum of 3·5 years. The primary efficacy outcome was the rate of first recurrence of symptomatic ischaemic stroke. Safety outcomes were severe or life-threatening bleeding; any adverse events; serious adverse events; and any bleeding events. Efficacy analyses were done in the intention-to-treat population and safety analyses were done in the as-treated population. This trial was registered with ClinicalTrials.gov (number NCT01995370) and UMIN Clinical Trials Registry (number 000012180).
FINDINGS
Participants were recruited from Dec 13, 2013, to March 31, 2017. 932 patients assigned to the dual therapy group and 947 patients assigned to the monotherapy group were included in the intention-to-treat analysis. The trial was stopped after the enrolment of 1884 patients of an anticipated 4000 patients because of the delay in recruitment. Ischaemic stroke recurred in 29 (3%) of 932 patients (annualised rate 2·2%) on dual therapy including cilostazol and 64 (7%) of 947 patients (annualised rate 4·5%) on monotherapy during a median 1·4 years follow-up (hazard ratio [HR] 0·49, 95% CI 0·31-0·76, p=0·0010). Severe or life-threatening bleeding occurred in eight patients (annualised rate 0·6%) on dual therapy and 13 patients (annualised rate 0·9%) on monotherapy (HR 0·66, 95% CI 0·27-1·60, p=0·35). Occurrence of any type of adverse event was similar between the groups (255 [28%] of 910 patients in the dual therapy group vs 219 [24%] of 921 patients in the monotherapy group); as was occurrence of serious adverse events (87 [10%] vs 142 [15%]) and bleeding events (38 [4%] vs 33 [4%]). Gastrointestinal bleeding, which affected nine (<1%) of 910 patients in the monotherapy group and nine (<1%) of 921 patients in the dual therapy group, was the most common type of bleeding.
INTERPRETATION
The combination of cilostazol with aspirin or clopidogrel had a reduced incidence of ischaemic stroke recurrence and a similar risk of severe or life-threatening bleeding compared with treatment with aspirin or clopidogrel alone in patients at high risk for recurrent ischaemic stroke.
FUNDING
Otsuka Pharmaceutical.",2019,Ischaemic stroke recurred in 29 (3%) of 932 patients (annualised rate 2·2%) on dual therapy including cilostazol and 64 (7%) of 947 patients (annualised rate 4·5%) on monotherapy during a median 1·4 years follow-up (hazard ratio [HR],"['932 patients assigned to the dual therapy group and 947 patients assigned to the', 'patients were required to have at least 50% stenosis of a major intracranial or extracranial artery or two or more of the vascular risk factors', '292 hospitals in Japan, patients with high-risk non-cardioembolic ischaemic stroke identified on MRI', '1884 patients of an anticipated 4000 patients because of the delay in recruitment', 'patients with high-risk ischaemic stroke in Japan', 'Participants were recruited from Dec 13, 2013, to March 31, 2017']","['cilostazol with aspirin or clopidogrel', 'clopidogrel', 'aspirin', 'aspirin or clopidogrel', 'cilostazol', 'monotherapy with either oral aspirin', 'monotherapy', 'aspirin and clopidogrel', 'Dual antiplatelet therapy using cilostazol']","['Gastrointestinal bleeding', 'severe or life-threatening bleeding', 'stroke recurrence', 'Ischaemic stroke', 'Occurrence of any type of adverse event', 'bleeding', 'ischaemic stroke recurrence', 'rate of first recurrence of symptomatic ischaemic stroke', 'bleeding events', 'Severe or life-threatening bleeding', 'severe or life-threatening bleeding; any adverse events; serious adverse events; and any bleeding events', 'occurrence of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.209276,Ischaemic stroke recurred in 29 (3%) of 932 patients (annualised rate 2·2%) on dual therapy including cilostazol and 64 (7%) of 947 patients (annualised rate 4·5%) on monotherapy during a median 1·4 years follow-up (hazard ratio [HR],"[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Centre, Osaka, Japan. Electronic address: totyoda@ncvc.go.jp.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'Clinical Research Centre for Medicine, International University of Health and Welfare, Tokyo, Japan; Centre for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Centre, Tokyo, Japan.'}, {'ForeName': 'Takenori', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Centre, Osaka, Japan.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Neurological Science, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Hoshino', 'Affiliation': 'Department of Neurology, Tokyo Saiseikai Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Sakai', 'Affiliation': 'Department of Neurosurgery, Kobe City Medical Centre General Hospital, Kobe, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Clinical Research Institute and Department of Cerebrovascular Medicine and Neurology, National Hospital Organisation Kyushu Medical Centre, Fukuoka, Japan.'}, {'ForeName': 'Kortaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Neurology, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Origasa', 'Affiliation': 'Division of Biostatistics and Clinical Epidemiology, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Naritomi', 'Affiliation': 'Department of Neurology, Senri Chuo Hospital, Toyonaka, Japan.'}, {'ForeName': 'Kiyohiro', 'Initials': 'K', 'LastName': 'Houkin', 'Affiliation': 'Department of Neurosurgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Neurology, Ichinomiya Nishi Hospital, Ichinomiya, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Isobe', 'Affiliation': 'Department of Neurosurgery, Kushiro Rosai Hospital, Kushiro, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'Headquarters of the Iseikai Medical Corporation, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30148-6']
1235,31142104,Effects of different exercise modalities on novel hepatic steatosis indices in overweight women with type 2 diabetes.,"BACKGROUND/AIMS
Fatty liver is a clinical and pathologic condition in individuals with type 2 diabetes (T2D). The purpose of this study is to examine the effects of different exercise modalities on non-alcoholic fatty liver indices (fatty liver index [FLI], lipid accumulation product [LAP], hepatic steatosis index [HSI], and Framingham Steatosis Index [FSI]) in women with T2D.
METHODS
Fifty-two women with T2D and a mean age of 55.07±5.92 yrs, body mass index (BMI) 28.94±4.09 kg/m2 , and hemoglobin A1c (HbA1c) 9.41±0.82% were randomized to a sprint interval training (SIT) (n=17), combined aerobic and resistance (A+R) training (n=17), or control group (n=18) for 10 weeks. Two-way repeated analysis of variance (ANOVA) was used to find differences between groups and the effects of time and Time×Group interactions after 10 weeks on non-alcoholic fatty liver indices. After this, ANOVA models were constructed to determine the effects of group allocation and change in non-alcoholic fatty liver indices.
RESULTS
There were significant time interactions for FLI (P<0.001), HSI (P<0.001), and LAP (P<0.001). Also, there were significant Time×Group interactions for fasting blood glucose (P=0.034), and HbA1c (P=0.006).
CONCLUSION
Results highlight that exercise training, independent of mode of training, is an effective strategy to improve some indices related to hepatic steatosis and blood glucose profiles in women with T2D.",2019,"There were significant time interactions for FLI (P<0.001), HSI (P<0.001), and LAP (P<0.001).","['individuals with type 2 diabetes (T2D', 'women with T2D', 'overweight women with type 2 diabetes', 'women with T2D.\nMethods\n\n\nFifty-two women with T2D and a mean age of 55.07±5.92 yrs, body mass index (BMI) 28.94±4.09 kg/m2 , and hemoglobin A1c (HbA1c) 9.41±0.82']","['exercise training', 'combined aerobic and resistance (A+R) training', 'exercise modalities', 'sprint interval training (SIT']","['hepatic steatosis and blood glucose profiles', 'fasting blood glucose', 'non-alcoholic fatty liver indices (fatty liver index [FLI], lipid accumulation product [LAP], hepatic steatosis index [HSI], and Framingham Steatosis Index [FSI', 'time interactions for FLI', 'novel hepatic steatosis indices']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C3658347', 'cui_str': 'Lipid Accumulation Product'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",52.0,0.0566632,"There were significant time interactions for FLI (P<0.001), HSI (P<0.001), and LAP (P<0.001).","[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Faculty of Humanities, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Faculty of Humanities, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Nasiri', 'Affiliation': 'Department of Sport Sciences, Faculty of Humanities, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mardaniyan', 'Affiliation': 'Department of Sport Sciences, Faculty of Humanities, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Rabiee', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Shahid Chamran University of Ahvaz, Ahvaz, Iran.'}]",Clinical and molecular hepatology,['10.3350/cmh.2018.0086']
1236,31078482,Outcomes and Effect of Treatment According to Etiology in HFrEF: An Analysis of PARADIGM-HF.,"OBJECTIVES
The purpose of this study was to compare outcomes (and the effect of sacubitril/valsartan) according to etiology in the PARADIGM-HF (Prospective comparison of angiotensin-receptor-neprilysin inhibitor [ARNI] with angiotensin-converting-enzyme inhibitor [ACEI] to Determine Impact on Global Mortality and morbidity in Heart Failure) trial.
BACKGROUND
Etiology of heart failure (HF) has changed over time in more developed countries and is also evolving in non-Western societies. Outcomes may vary according to etiology, as may the effects of therapy.
METHODS
We examined outcomes and the effect of sacubtril/valsartan according to investigator-reported etiology in PARADIGM-HF. The outcomes analyzed were the primary composite of cardiovascular death or HF hospitalization, and components, and death from any cause. Outcomes were adjusted for known prognostic variables including N terminal pro-B type natriuretic peptide.
RESULTS
Among the 8,399 patients randomized, 5,036 patients (60.0%) had an ischemic etiology. Among the 3,363 patients (40.0%) with a nonischemic etiology, 1,595 (19.0% of all patients; 47% of nonischemic patients) had idiopathic dilated cardiomyopathy, 968 (11.5% of all patients; 28.8% of nonischemic patients) had a hypertensive cause, and 800 (9.5% of all patients, 23.8% of nonischemic patients) another cause (185 infective/viral, 158 alcoholic, 110 valvular, 66 diabetes, 30 drug-related, 14 peripartum-related, and 237 other). Whereas the unadjusted rates of all outcomes were highest in patients with an ischemic etiology, the adjusted hazard ratios (HRs) were not different from patients in the 2 major nonischemic etiology categories; for example, for the primary outcome, compared with ischemic (HR: 1.00), hypertensive 0.87 (95% confidence interval [CI]: 0.75 to 1.02), idiopathic 0.92 (95% CI: 0.82 to 1.04) and other 1.00 (95% CI: 0.85 to 1.17). The benefit of sacubitril/valsartan over enalapril was consistent across etiologic categories (interaction for primary outcome; p = 0.11).
CONCLUSIONS
Just under one-half of patients in this global trial had nonischemic HF with reduced ejection fraction, with idiopathic and hypertensive the most commonly ascribed etiologies. Adjusted outcomes were similar across etiologic categories, as was the benefit of sacubitril/valsartan over enalapril. (Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure; NCT01035255).",2019,"Whereas the unadjusted rates of all outcomes were highest in patients with an ischemic etiology, the adjusted hazard ratios (HRs) were not different from patients in the 2 major nonischemic etiology categories; for example, for the primary outcome, compared with ischemic (HR: 1.00), hypertensive 0.87","['Patients With Chronic Heart\xa0Failure', 'another cause (185 infective/viral, 158 alcoholic, 110 valvular, 66 diabetes, 30 drug-related, 14 peripartum-related, and 237 other', '8,399 patients randomized, 5,036 patients (60.0%) had an ischemic etiology']","['enalapril', 'angiotensin-receptor-neprilysin inhibitor [ARNI', 'Enalapril', 'angiotensin-converting-enzyme inhibitor [ACEI', 'sacubitril/valsartan', 'LCZ696', 'sacubtril/valsartan']","['idiopathic dilated cardiomyopathy', 'hypertensive cause', 'cardiovascular death or HF hospitalization, and components, and death from any cause', 'Morbidity and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0687725', 'cui_str': 'Alcoholics'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2936491', 'cui_str': 'Peripartum'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C1449563', 'cui_str': 'Cardiomyopathy, Dilated, LMNA'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",8399.0,0.177835,"Whereas the unadjusted rates of all outcomes were highest in patients with an ischemic etiology, the adjusted hazard ratios (HRs) were not different from patients in the 2 major nonischemic etiology categories; for example, for the primary outcome, compared with ischemic (HR: 1.00), hypertensive 0.87","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Balmforth', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Adel R', 'Initials': 'AR', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute and University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.02.015']
1237,31120274,The association of maternal alcohol use and paraprofessional home visiting with children's health: A randomized controlled trial.,"OBJECTIVE
This study examines the effect of a home visiting intervention on maternal alcohol use, problematic drinking, and the association of home visiting and alcohol use on children's behavioral, cognitive, and health outcomes at 5 time points over 5 years.
METHOD
We analyzed 5,099 observations of 1,236 mothers and their children from pregnancy to 5 years postbirth, within a longitudinal cluster-randomized trial evaluating the effect of a home visiting intervention on mothers in Cape Town, South Africa. Paraprofessional home visitors coached mothers on coping with multiple risk factors, including a brief, 1-visit intervention on alcohol prevention in pregnancy. We assessed changes in maternal drinking over time in relation to the intervention, and then examined the impact of these drinking patterns on child outcomes over five years.
RESULTS
Drinking increased over the 5 years postbirth, but it was significantly lower in the intervention condition. Compared with abstinence, mothers' problematic drinking was associated with decreased child weight (-0.21 z-units) at all assessments, increased child aggressive behavior (3 to 7 additional symptoms), and decreased child performance on an executive functioning measure (the silly sounds task; odds ratio = .34) at 3 and 5 years. The intervention's effect was associated with increased child aggression (0.25 to 0.75 of 1 additional symptom), but the intervention appeared to decrease the effect of problem drinking on children's aggressive acts and executive functioning.
CONCLUSION
These findings support the need for sustained interventions to reduce alcohol use, especially for mothers who exhibit problematic drinking. Maternal drinking influences children's health and development over time. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"The intervention's effect was associated with increased child aggression (0.25 to 0.75 of 1 additional symptom), but the intervention appeared to decrease the effect of problem drinking on children's aggressive acts and executive functioning.
","['mothers in Cape Town, South Africa', ""with children's health"", 'mothers who exhibit problematic drinking', 'Paraprofessional home visitors coached mothers on coping with multiple risk factors', '1,236 mothers and their children from pregnancy to 5 years postbirth']","['paraprofessional home visiting', 'home visiting intervention']","['Drinking', ""children's aggressive acts and executive functioning"", 'child aggression', 'child aggressive behavior', 'child performance on an executive functioning measure', ""children's behavioral, cognitive, and health outcomes"", 'child weight']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0020043', 'cui_str': 'Home Visits'}]","[{'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0221429,"The intervention's effect was associated with increased child aggression (0.25 to 0.75 of 1 additional symptom), but the intervention appeared to decrease the effect of problem drinking on children's aggressive acts and executive functioning.
","[{'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences.'}, {'ForeName': 'Kodi B', 'Initials': 'KB', 'LastName': 'Arfer', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Christodoulou', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences.'}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Comulada', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychology, Stellenbosch University.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Tubert', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California, Los Angeles.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Psychology, Stellenbosch University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000408']
1238,31120480,The Search for and Conduct of the Elusive Phase 3 Randomized Clinical Trial: Snipe Hunting With the Military.,,2019,,[],[],[],[],[],[],,0.0793877,,"[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Formby', 'Affiliation': 'Department of Communicative Disorders, University of Alabama, Tuscaloosa.'}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0830']
1239,31138501,Morphometric Assessment of Resected Femoral Cut Surface in Korean Knees and Its Fitting With Western-Designed Femoral Components.,"BACKGROUND
This study aimed at assessing the morphometry of resected femurs in Korean patients during total knee arthroplasty (TKA) and comparing these measurements with current Western-designed femoral component dimensions.
METHODS
This single-blind, prospective, randomized, controlled trial involved intraoperative measurements for 271 femoral component implantations from 3 contemporary TKA systems, with 2 systems offering narrow sizing options. The difference between femoral component dimensions and the resected surface of distal femur was measured in millimeters at 5 distinct zones.
RESULTS
Overhang of standard femoral component was common in the anterior-medial condyle and anterior-lateral condyle ranging from 50.8% to 99.0% and 21.5% to 88.0%, respectively. With narrow femoral components, the rate of overhang reduced to 21.5%-30.2% and 9.2%-32.1%. Conversely, underhang rates were higher over the anterior flange width, middle medial-lateral and posterior medial-lateral zones. Standard components displayed higher underhang rates at these zones compared to narrow components. The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%. System with narrow option sizing increases the underhang rates in males, while improving the component fit among females at similar zones with rate ranging from 5.2% to 52.9%.
CONCLUSION
Currently available TKA implant designs may not provide a perfect match for the distal femoral shape of the Korean population. The availability of implants with standard and narrow options can substantially improve the optimal fitting of femoral components in the Korean population.",2019,The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%.,"['271 femoral component implantations from 3 contemporary TKA systems, with 2 systems offering narrow sizing options', 'Korean patients during total knee arthroplasty (TKA']",[],"['femoral component dimensions and the resected surface of distal femur', 'femoral component', 'rate of overhang', 'underhang rates']","[{'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]",[],"[{'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]",271.0,0.0755389,The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%.,"[{'ForeName': 'Teck S', 'Initials': 'TS', 'LastName': 'Fong', 'Affiliation': 'Department of Orthopaedic Surgery, Putrajaya Hospital, Federal Government Administrative Centre, Putrajaya, Malaysia; Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Seong Chan', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Ji Eui', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Eui Soo', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Tae Woo', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Yong Seuk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.061']
1240,31122495,"Safety of the tau-directed monoclonal antibody BIIB092 in progressive supranuclear palsy: a randomised, placebo-controlled, multiple ascending dose phase 1b trial.","BACKGROUND
Progressive supranuclear palsy is a rare neurodegenerative disease associated with dysfunctional tau protein. BIIB092 is a humanised monoclonal antibody that binds to N-terminal tau and is thus being assessed as a potential novel treatment for progressive supranuclear palsy. We aimed to investigate the safety and tolerability of BIIB092 in individuals with progressive supranuclear palsy.
METHODS
This 12-week, double-blind, randomised, placebo-controlled, multiple ascending dose, phase 1b trial was done at 13 outpatient sites in the USA. Participants aged 41-86 years with probable or possible progressive supranuclear palsy with a score of 20 or greater on the Mini-Mental State Examination (MMSE) were enrolled. Three BIIB092 dose escalation cohorts (150 mg, 700 mg, or 2100 mg; eight participants per cohort) were tested sequentially. For each dose cohort, the first two participants were randomly assigned by a computer-generated scheme to receive either BIIB092 or placebo intravenously every 4 weeks for 57 days. After 2 days, the six remaining participants in each cohort were randomly assigned (5:1) to receive BIIB092 or placebo for 57 days. An additional expansion panel of 24 patients was randomly assigned (3:1) to receive 2100 mg or placebo every 4 weeks for 57 days. All participants were followed up to day 85. The primary outcome was safety, which was analysed in the treated population (all enrolled participants who received at least one dose of the study drug). This trial is registered with ClinicalTrials.gov, NCT02460094.
FINDINGS
Between Oct 2, 2015, and Oct 19, 2016, 48 participants were enrolled and randomly assigned to the BIIB092 (n=36) and placebo (n=12) groups. No apparent demographic differences were observed between the two groups at baseline. All 48 participants completed the treatment phase of the study. Adverse events were generally mild to moderate in severity; the most common in the placebo and BIIB092 groups were falls (in two [17%] of 12 patients and in ten [28%] of 36 patients), urinary tract infections (in one [8%] of 12 and in six [17%] of 36), contusions (in one [8%] of 12 and in five [14%] of 36), and headaches (in none and in five [14%] of 36). Four serious adverse events resulting in admission to hospital were reported in three participants who received BIIB092 2100 mg: two severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia. None was considered to be related to the study drug, all were resolved, and no deaths were reported.
INTERPRETATION
Repeated administration of the anti-tau monoclonal antibody BIIB092, at doses of up to 2100 mg, appears to be well tolerated in participants with progressive supranuclear palsy. Results of this phase 1b trial have informed the design of the ongoing phase 2 PASSPORT (NCT03068468) study to examine the efficacy and safety of BIIB092.
FUNDING
Bristol-Myers Squibb, Biogen.",2019,"Four serious adverse events resulting in admission to hospital were reported in three participants who received BIIB092 2100 mg: two severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia.","['Participants aged 41-86 years with probable or possible progressive supranuclear palsy with a score of 20 or greater on the Mini-Mental State Examination (MMSE) were enrolled', 'Between Oct 2, 2015, and Oct 19, 2016, 48 participants were enrolled and randomly assigned to the BIIB092 (n=36) and', 'progressive supranuclear palsy', 'participants with progressive supranuclear palsy', 'individuals with progressive supranuclear palsy', '24 patients', 'All 48 participants completed the treatment phase of the study']","['BIIB092 or placebo', 'placebo', 'tau-directed monoclonal antibody BIIB092']","['Adverse events', 'safety and tolerability', 'severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia', 'headaches', 'urinary tract infections']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0038868', 'cui_str': 'Steele-Richardson-Olszewski Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0032290', 'cui_str': 'Aspiration Pneumonia'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",48.0,0.474552,"Four serious adverse events resulting in admission to hospital were reported in three participants who received BIIB092 2100 mg: two severe adverse events of urinary tract infection, one severe adverse event of change in mental status, and one moderate adverse event of aspiration pneumonia.","[{'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Boxer', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Qureshi', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ahlijanian', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grundman', 'Affiliation': 'Global R&D Partners, LLC, San Diego, CA, USA; University of California, San Diego, CA, USA.'}, {'ForeName': 'Lawrence I', 'Initials': 'LI', 'LastName': 'Golbe', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Litvan', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Honig', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tuite', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nikolaus R', 'Initials': 'NR', 'LastName': 'McFarland', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': ""O'Suilleabhain"", 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xie', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Giridhar S', 'Initials': 'GS', 'LastName': 'Tirucherai', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Bechtold', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Bordelon', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Geldmacher', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Grossman', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': 'Boca Raton Institute for Neurodegenerative Disorders, Boca Raton, FL, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Zesiewicz', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Olsson', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Kumar Kandadi', 'Initials': 'KK', 'LastName': 'Muralidharan', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Graham', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Gorman"", 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Samantha Budd', 'Initials': 'SB', 'LastName': 'Haeberlein', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Tien', 'Initials': 'T', 'LastName': 'Dam', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: tien.dam@biogen.com.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30139-5']
1241,31122717,Short period of high-intensity inspiratory muscle training improves inspiratory muscle strength in patients with chronic kidney disease on hemodialysis: a randomized controlled trial.,"BACKGROUND
Chronic kidney disease is a complex disease that impacts multiple organs and systems (including musculoskeletal and cardiorespiratory) leading to reduction of functional capacity.
OBJECTIVE
The aim of this study was to investigate the effect of a short period of high intensity inspiratory muscle training on maximum inspiratory pressure, functional capacity and endothelial function of chronic kidney disease patients on hemodialysis.
METHODS
This randomized controlled trial enrolled 25 patients who were allocated into two groups: intervention (IMTG=14) and control (CG=11) groups. Intervention patients received the exercise protocol over a period of 5 weeks, 6 times per week, with each session consisting of 5 sets of 10 repetitions with an initial load of 50% progressing to 70% of maximum inspiratory pressure , measured weekly. The primary outcome was inspiratory muscle strength and the secondary outcomes were functional capacity and endothelial function evaluated before and after the training protocol.
RESULTS
The inspiratory muscle training induced a marked improvement in maximum inspiratory pressure which was evident after the training period (mean difference 19.0cmH 2 O - 95%CI 0.4-37.5; IMTG: 102±25.7cmH 2 O vs CG: 83±19.2; p=0.046). The magnitude of maximum inspiratory pressure improvement was 33.5% at the end of the protocol for the IMTG. Functional capacity and endothelial function did not vary between or within groups.
CONCLUSION
A short period of high-intensity inspiratory muscle training for five weeks was able to improve inspiratory muscle strength of chronic kidney disease patients on hemodialysis (ClinicalTrials.gov registration NCT03082404).",2020,A short period of high-intensity inspiratory muscle training for five weeks was able to improve inspiratory muscle strength of chronic kidney disease patients on hemodialysis (ClinicalTrials.gov registration NCT03082404).,"['chronic kidney disease patients', 'patients with chronic kidney disease on hemodialysis', 'chronic kidney disease patients on hemodialysis', '25 patients']","['high intensity inspiratory muscle training', 'high-intensity inspiratory muscle training', 'exercise protocol', 'IMTG']","['inspiratory muscle strength', 'maximum inspiratory pressure improvement', 'maximum inspiratory pressure, functional capacity and endothelial function', 'maximum inspiratory pressure', 'Functional capacity and endothelial function', 'inspiratory muscle strength and the secondary outcomes were functional capacity and endothelial function']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",25.0,0.10348,A short period of high-intensity inspiratory muscle training for five weeks was able to improve inspiratory muscle strength of chronic kidney disease patients on hemodialysis (ClinicalTrials.gov registration NCT03082404).,"[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dipp', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. Electronic address: thdipp@hotmail.com.'}, {'ForeName': 'Fabrício Edler', 'Initials': 'FE', 'LastName': 'Macagnan', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jociane', 'Initials': 'J', 'LastName': 'Schardong', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rafael Oliveira', 'Initials': 'RO', 'LastName': 'Fernandes', 'Affiliation': 'Department of Physiology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Luisa Cioato', 'Initials': 'LC', 'LastName': 'Lemos', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rodrigo Della Méa', 'Initials': 'RDM', 'LastName': 'Plentz', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.04.003']
1242,31753429,The Electrical Isolation of the Left Atrial Posterior Wall in Catheter Ablation of Persistent Atrial Fibrillation.,"OBJECTIVES
This study explored whether complete electrical isolation of the left atrial (LA) posterior wall improves the rhythm outcome of catheter ablation of persistent atrial fibrillation (AF).
BACKGROUND
Although the STAR AF2 (Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II) proved no additional benefit of empirical extra-pulmonary vein (PV) LA ablation, the long-term recurrence rate after circumferential PV isolation (CPVI) alone remains high.
METHODS
We randomly assigned 217 patients with persistent AF (83.1% men, age 58.7 ± 10.8 years, 73.3% long-standing persistent AF) to ablation with CPVI alone (CPVI group) or CPVI with a POsterior wall Box Isolation (POBI group). The endpoint of the POBI group was the elimination of the posterior atrial potentials by roof and posterior inferior lines and touch-up focal ablation.
RESULTS
After a mean follow-up of 16.2 ± 8.8 months, the clinical recurrence rate did not significantly differ between the 2 groups (23.8% vs. 26.5%; p = 0.779) in the CPVI and POBI groups. The recurrence rate for atrial tachycardias (16.0% vs. 11.1%; p = 0.913) and cardioversion rates (6.7% vs. 13.7%; p = 0.093) to control clinical recurrences also did not significantly differ between the 2 groups. At the final follow-up, sinus rhythm was maintained without antiarrhythmic drug in 50.5% and 55.9% in the CPVI and POBI groups, respectively (p = 0.522). No significant difference was found in the major complication rates between the 2 groups, but the total ablation time was significantly longer in the POBI group (4,289 ± 1,837 s vs. 5,365 ± 2,358 s; p < 0.001).
CONCLUSIONS
In patients with persistent AF, an empirical complete POBI did not improve the rhythm outcome of catheter ablation or influence the type of recurrent atrial arrhythmia. (Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial; NCT02721121).",2019,"No significant difference was found in the major complication rates between the 2 groups, but the total ablation time was significantly longer in the POBI group (4,289 ± 1,837 s vs. 5,365 ± 2,358 s;","['Persistent Atrial Fibrillation', '217 patients with persistent AF (83.1% men, age 58.7 ± 10.8 years, 73.3% long-standing persistent AF) to ablation with CPVI alone (CPVI group) or CPVI with a POsterior wall Box Isolation (POBI group']","['Circumferential Pulmonary Vein Isolation', 'Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation', 'STAR AF2 (Substrate and Trigger Ablation']","['cardioversion rates', 'elimination of the posterior atrial potentials by roof and posterior inferior lines and touch-up focal ablation', 'total ablation time', 'major complication rates', 'clinical recurrence rate', 'rhythm outcome of catheter ablation', 'control clinical recurrences', 'recurrence rate for atrial tachycardias']","[{'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442071', 'cui_str': 'Posterior wall (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0220862', 'cui_str': 'isolation'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0878311', 'cui_str': 'AF-2'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]","[{'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}]",217.0,0.0326653,"No significant difference was found in the major complication rates between the 2 groups, but the total ablation time was significantly longer in the POBI group (4,289 ± 1,837 s vs. 5,365 ± 2,358 s;","[{'ForeName': 'Jung Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Kyung Hee University Medical College, Seoul, Republic of Korea.'}, {'ForeName': 'Jaemin', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Korea University Cardiovascular Center, Seoul, Republic of Korea.'}, {'ForeName': 'Junbeom', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Tae', 'Initials': 'HT', 'LastName': 'Yu', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Tae-Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Sun', 'Initials': 'JS', 'LastName': 'Uhm', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Bae', 'Initials': 'JB', 'LastName': 'Kim', 'Affiliation': 'Kyung Hee University Medical College, Seoul, Republic of Korea.'}, {'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Joung', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Moon-Hyoung', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Korea University Cardiovascular Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hui-Nam', 'Initials': 'HN', 'LastName': 'Pak', 'Affiliation': 'Yonsei University Health System, Seoul, Republic of Korea. Electronic address: hnpak@yuhs.ac.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.08.021']
1243,31425224,Is Tube Thermosoftening Helpful for Videolaryngoscope-Guided Nasotracheal Intubation?: A Randomized Controlled Trial.,"BACKGROUND
Thermosoftening of the endotracheal tube (ETT) and telescoping the ETT into a rubber catheter have been suggested as a method for reducing epistaxis during nasotracheal intubation (NTI). However, thermosoftening technique is known to make it difficult to navigate the ETT into trachea without the use of Magill forceps during NTI. The cuff inflation technique has been suggested as an effective alternative to the use of Magill forceps to improve the oropharyngeal navigation of the ETT, irrespective of their stiffness, during direct laryngoscope-guided NTI. We evaluated whether thermosoftening of the ETT telescoped into rubber catheters has an additional benefit in reducing nasal injury. Simultaneously, we also evaluated whether thermosoftening of the ETT worsened orotracheal navigability during cuff inflation-supplemented videolaryngoscope-guided NTI.
METHODS
One hundred forty patients were randomly assigned to 1 of the 2 groups depending on whether the ETT was softened by warming or not. The primary outcome was the incidence of epistaxis during NTI. The secondary outcome was nasotracheal navigability of the ETT, assessed by navigation grade and time required for insertion of ETT in each phase (from nose to oropharynx, from oropharynx to glottic inlet aided by cuff inflation if needed, and from glottic inlet to trachea).
RESULTS
The ETTs were successfully inserted through the selected nostril of all 140 patients. In the thermosoftening group, the incidence and severity of epistaxis was significantly lower (7% vs 51%; difference of 44.2%; 95% confidence interval, 29.9%-56.2%; P < .001), and the ETT passed through the nasal cavity with lower resistance (P = .001) and less time (P < .001) when compared to the control group. No difference was found in the ease of ETT insertion (navigation grade and time required) from the oropharynx to the glottic inlet (P > .99 and P = .054, respectively) and from the glottic inlet to the trachea (P > .99 and P = .750, respectively) between the 2 groups. In both groups, all ETTs could be navigated into the trachea without the use of Magill forceps.
CONCLUSIONS
Supplemented with cuff inflation during videolaryngoscope-guided NTI, thermosoftening of the ETT telescoped into rubber catheters has a substantial benefit because it significantly reduces the incidence of epistaxis without worsening the oropharyngeal navigability of the ETT.",2019,"No difference was found in the ease of ETT insertion (navigation grade and time required) from the oropharynx to the glottic inlet (P > .99 and P = .054, respectively) and from the glottic inlet to the trachea (P > .99 and P = .750, respectively) between the 2 groups.",['One hundred forty patients'],[],"['ease of ETT insertion (navigation grade and time required) from the oropharynx to the glottic inlet', 'nasotracheal navigability of the ETT, assessed by navigation grade and time required for insertion of ETT in each phase (from nose to oropharynx, from oropharynx to glottic inlet aided by cuff inflation if needed, and from glottic inlet to trachea', 'incidence and severity of epistaxis', 'incidence of epistaxis during NTI']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C3179046', 'cui_str': 'Inlets'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0040578', 'cui_str': 'Trachea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}]",140.0,0.0625362,"No difference was found in the ease of ETT insertion (navigation grade and time required) from the oropharynx to the glottic inlet (P > .99 and P = .054, respectively) and from the glottic inlet to the trachea (P > .99 and P = .750, respectively) between the 2 groups.","[{'ForeName': 'Eun Mi', 'Initials': 'EM', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Mi Hwa', 'Initials': 'MH', 'LastName': 'Chung', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Mi Hyeon', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Hongje Nara Pain Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Mi', 'Initials': 'EM', 'LastName': 'Choi', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jung', 'Initials': 'IJ', 'LastName': 'Jun', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Hyung', 'Initials': 'TH', 'LastName': 'Yun', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong Kuk', 'Initials': 'YK', 'LastName': 'Ko', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Hallym University Kangnam Sacred Heart Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Jun', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003822']
1244,31140569,"Home-Based, Adaptive Cognitive Training for Cognitively Normal Older adults: Initial Efficacy Trial.","OBJECTIVES
We examined whether a home-based, adaptive cognitive training (CT) program would lead to cognitive performance changes on a neuropsychological test battery in cognitively normal older adults.
METHOD
Sixty-eight older adults (age = 70.0, SD = 3.74) were randomly assigned to either CT or an active control group (AC, casual computer games). Participants were instructed to train on their assigned programs for 42 min per day, 5 days per week, over 10 weeks (35 hr of total program usage). Participants completed tests of processing speed, working memory, and executive control before and after 10 weeks of training.
RESULTS
Training groups did not differ in performance before training. After training, CT participants out-performed AC participants in the overall cognitive composite score, driven by processing speed and working memory domains.
DISCUSSION
Our results show that a limited dose of home-based CT can drive cognitive improvements as measured with neuropsychological test battery, suggesting potential cognitive health maintenance implications for cognitively normal older adults.",2020,"After training, CT participants out-performed AC participants in the overall cognitive composite score, driven by processing speed and working memory domains.
","['Healthy Older Adults', 'Sixty-eight older adults (age = 70.0, SD=3.74', 'cognitively normal older adults']","['Home-Based, Adaptive Cognitive Training', 'home-based, adaptive cognitive training program', 'cognitive training (CT) or an active control group (AC, casual computer games', 'home-based cognitive training']","['processing speed, working memory, and executive control', 'overall cognitive composite score, driven by processing speed and working memory domains']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}]","[{'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",68.0,0.0209864,"After training, CT participants out-performed AC participants in the overall cognitive composite score, driven by processing speed and working memory domains.
","[{'ForeName': 'Hyun Kyu', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': 'Department of Research and Development, Posit Science Inc., San Francisco, California.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Kent', 'Affiliation': 'Interdisciplinary Graduate Program in Neuroscience, University of Iowa, Iowa.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wendel', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa.'}, {'ForeName': 'Fredric D', 'Initials': 'FD', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Health Management and Policy, College of Public Health, University of Iowa, Iowa.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Foster', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Iowa, Iowa.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Merzenich', 'Affiliation': 'Department of Research and Development, Posit Science Inc., San Francisco, California.'}, {'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Voss', 'Affiliation': 'Interdisciplinary Graduate Program in Neuroscience, University of Iowa, Iowa.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz073']
1245,31125576,Pravastatin combination with sorafenib does not improve survival in advanced hepatocellular carcinoma.,"BACKGROUND & AIMS
Sorafenib is the standard of care for advanced hepatocellular carcinoma (HCC). Combining sorafenib with another treatment, to improve overall survival (OS) within an acceptable safety profile, might be the next step forward in the management of patients with advanced HCC. We aimed to assess whether a combination of sorafenib and a statin improved survival in patients with HCC.
METHODS
The objective of the PRODIGE-11 trial was to compare the respective clinical outcomes of the sorafenib-pravastatin combination (arm A) versus sorafenib alone (arm B) in patients with advanced HCC. Child-Pugh A patients with advanced HCC who were naive to systemic treatment (n = 323) were randomly assigned to sorafenib-pravastatin combination (n = 162) or sorafenib alone (n = 161). The primary endpoint was OS; secondary endpoints were progression-free survival, time to tumor progression, time to treatment failure, safety, and quality of life.
RESULTS
After randomization, 312 patients received at least 1 dose of study treatment. After a median follow-up of 35 months, 269 patients died (arm A: 135; arm B: 134) with no difference in median OS between treatments arms (10.7 months vs. 10.5 months; hazard ratio = 1.00; p = 0.975); no difference was observed in secondary survival endpoints either. In the univariate analysis, the significant prognostic factors for OS were CLIP score, performance status, and quality of life scores. The multivariate analysis showed that the only prognostic factor for OS was the CLIP score. The main toxicity was diarrhea (which was severe in 11% of patients in arm A, and 8.9% in arm B), while severe nausea-vomiting was rare, and no toxicity-related deaths were reported.
CONCLUSION
Adding pravastatin to sorafenib did not improve survival in patients with advanced HCC.
LAY SUMMARY
Sorafenib has proven efficacy for the treatment of patients with advanced hepatocellular carcinoma. However, overall survival remains poor in these patients, so we were interested to see if the addition of a statin, pravastatin, improved outcomes in patients with advanced HCC. This randomized-controlled trial demonstrated that the sorafenib-pravastatin combination did not improve overall survival in this study population compared to sorafenib alone. Clinical trial number: NCT01075555.",2019,"The main toxicity was diarrhea (severe for 11% in arm A, and 8.9% in arm B), while severe nausea-vomiting was rare, and no toxic death was to deplore.
","['patients with advanced HCC', 'advanced Hepatocellular Carcinoma', 'Pugh A patients with advanced HCC who were naive to systemic treatment (n = 323', 'hepatocellular carcinoma (HCC']","['sorafenib-pravastatin combination (arm A) vs sorafenib alone', 'sorafenib-pravastatin combination', 'sorafenib-pravastatin', 'sorafenib alone', 'Pravastatin', 'Sorafenib', 'pravastatin', 'sorafenib']","['survival', 'secondary survival endpoints', 'CLIP score, performance status, and QoL scores', 'toxic death', 'median OS', 'progression-free survival, time to tumor progression, time to treatment failure, safety, and quality of life (QoL', 'overall survival (OS', 'severe nausea-vomiting', 'diarrhea (severe', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression (finding)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",323.0,0.259726,"The main toxicity was diarrhea (severe for 11% in arm A, and 8.9% in arm B), while severe nausea-vomiting was rare, and no toxic death was to deplore.
","[{'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Jouve', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital F. Mitterrand, Dijon, France. Electronic address: jean-louis.jouve@chu-dijon.fr.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Trousseau, Tours, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouché', 'Affiliation': 'Department of Hepato-Gastroenterology, Robert Debré Hospital, Reims, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Barbier', 'Affiliation': 'Fédération Française de Cancérologie Digestive (FFCD), Dijon, France.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Khemissa Akouz', 'Affiliation': 'Department of Hepato-Gastroenterology, Saint-Jean Hospital, Perpignan, France.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'Riachi', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Charles Nicolle, Rouen, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Nguyen Khac', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Nord, Amiens, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ollivier-Hourmand', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Côte de Nacre, Caen, France.'}, {'ForeName': 'Maryline', 'Initials': 'M', 'LastName': 'Debette-Gratien', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Dupuytren, Limoges, France.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'Department of Hepato-Gastroenterology, Les Oudairies Hospital, La Roche-sur-Yon, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Villing', 'Affiliation': 'Department of Medical Oncology, Auxerre Hospital, Auxerre, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Vergniol', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Haut-Lévêque, Pessac, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Ramee', 'Affiliation': 'Department of Medical Oncology, Centre Catherine de Sienne, Nantes, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bronowicki', 'Affiliation': 'INSERM U954, University of Lorraine and University Hospital of Nancy, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': 'Department of Oncology and Hepato-Gastroenterology, University Hospital La Timone, Marseille, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Legoux', 'Affiliation': 'Department of Hepato-Gastroenterology, La Source Hospital, Orléans, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Denis', 'Affiliation': 'Department of Hepato-Gastroenterology, Louise Michel Hospital, Evry, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Manfredi', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital F. Mitterrand, Dijon, France; INSERM U1231, University of Bourgogne - Franche-Comté, Faculté de Médecine, Dijon, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Phelip', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital of Saint-Etienne - Hôpital Nord, Saint-Priest-en-Jarez, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hepatology,['10.1016/j.jhep.2019.04.021']
1246,31262691,Slightly elevated thyrotropin levels in pregnancy in our clinical practice.,"OBJECTIVE
The aim of this study was to assess the incidence of obstetric and neonatal complications in pregnant women with ""normal"" thyroid-stimulating hormone (TSH) levels in the first trimester (group A) and to compare them with those with ""slightly elevated"" TSH (SET) levels treated with levothyroxine (group B2) or not treated (group B1).
METHODS
A total of 2375 women who had been performed laboratory tests in their first trimester of pregnancy were detected at our hospital between April 2015 and August 2017. Of these, 469 patients with SET were prospectively detected and randomized to groups B1 (227) and B2 (242). They were monitored prospectively until 6 months after delivery. Data of the control group (n=1906, group A) were retrospectively reviewed. A total of 1745 women were analyzed. Variables assessed included demographic and clinical characteristics and complications of pregnancy and delivery.
RESULTS
A, B1, and B2 had similar clinical characteristics. There were no statistically significant differences in complications between the three groups during pregnancy, except in that natural deliveries were more common in group A as compared to group B1 (76.8% vs. 68.7%, p 0.017) and group B2 (66.3%), p<0.002). There were more induced deliveries in groups B1 (35.8%), and B2 (36.2%) than in group A (18.4%), p<0.01. Although the recommended TSH level was achieved in the second and third trimesters, no benefit could be found of treatment of SET.
CONCLUSION
Although there were less natural deliveries and more induced deliveries in patients with SET, treatment with levothyroxine could not reverse this situation, despite achievement of levels considered appropriate in the second and third trimester.",2019,"There were no statistically significant differences in complications between the three groups during pregnancy, except in that natural deliveries were more common in group A as compared to group B1 (76.8% vs. 68.7%, p 0.017) and group B2 (66.3%), p<0.002).","['pregnant women with ""normal"" thyroid-stimulating hormone (TSH) levels in the first trimester (group A) and to compare them with those with ""slightly elevated"" TSH (SET) levels treated with', 'group B2) or not treated (group B1', 'A total of 1745 women were analyzed', '469 patients with SET', '2375 women who had been performed laboratory tests in their first trimester of pregnancy were detected at our hospital between April 2015 and August 2017']",['levothyroxine'],"['demographic and clinical characteristics and complications of pregnancy and delivery', 'thyrotropin levels', 'incidence of obstetric and neonatal complications', 'complications', 'TSH level']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0032979', 'cui_str': 'Early Placental Phase'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",2375.0,0.0586457,"There were no statistically significant differences in complications between the three groups during pregnancy, except in that natural deliveries were more common in group A as compared to group B1 (76.8% vs. 68.7%, p 0.017) and group B2 (66.3%), p<0.002).","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Alcázar Lázaro', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain. Electronic address: victoria.alcazar@gmail.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'López Del Val', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'García Lacalle', 'Affiliation': 'Servicio de Análisis Clínicos, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Torres Moreno', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Castillo Carvajal', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.'}, {'ForeName': 'Lucrecia', 'Initials': 'L', 'LastName': 'Vergara Fernández', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Benfdil', 'Affiliation': 'Universidad Alfonso X El Sabio, Villanueva de la Cañada, Madrid, Spain.'}, {'ForeName': 'Covadonga', 'Initials': 'C', 'LastName': 'Torre Carrera', 'Affiliation': 'Universidad Alfonso X El Sabio, Villanueva de la Cañada, Madrid, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'Orizales Lago', 'Affiliation': 'Servicio de Ginecología y Obstetricia, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Ramos Zuñiga', 'Affiliation': 'Servicio de Ginecología y Obstetricia, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.'}]","Endocrinologia, diabetes y nutricion",['10.1016/j.endinu.2019.03.020']
1247,31120533,Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial.,"Importance
Tinnitus retraining therapy (TRT) is an internationally recognized, but controversial, protocol of uncertain efficacy that uses tinnitus-specific educational counseling (TC) and sound therapy (ST) to reduce the patient's tinnitus-evoked negative reaction to, and awareness of, tinnitus.
Objective
To compare the efficacy of TRT and its components, ST and TC, with the standard of care (SoC) in reducing the negative effect of tinnitus on quality of life.
Design, Setting, and Participants
A randomized, placebo-controlled, multicenter phase 3 trial was conducted from August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus. All analyses were based on intention to treat.
Interventions
Central randomized allocation to TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC.
Main Outcomes and Measures
The primary outcome was mean change on the Tinnitus Questionnaire (TQ), assessed longitudinally between baseline and 18 months after start of therapy. The secondary outcomes were changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS).
Results
Among the 151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years), 51 were randomized to receive TRT, 51 to receive partial TRT, and 49 to receive standard of care. Longitudinal analyses showed no difference between partial TRT or TRT compared with SoC, or partial TRT compared with TRT, on TQ, TFI, or THI total scores. Comparison of changes in mean score from baseline to the 18-month visit also showed no difference between treatment groups. Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61). Compared with baseline scores, at 18 months there were reductions in scores by 7 points or more on the TQ score for 86 of 111 participants (77.55%; 95% CI, 69.7%-85.2%), 13 points or more on the TFI for 52 of 111 participants (46.8%; 95% CI, 37.6%-56.1%), 7 points or more on the THI for 63 of 111 participants (56.8%; 95% CI, 47.5%-66.0%), and 2 points or more on the VAS for 45 of 93 participants (48.4%; 95% CI, 38.2%-58.5%).
Conclusions and Relevance
There were few differences between treatment groups. About half of participants showed clinically meaningful reductions in the effect of tinnitus.
Trial Registration
ClinicalTrials.gov identifier: NCT01177137.",2019,"Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61).","['151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years', ""August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus""]","['Tinnitus Retraining Therapy vs Standard of Care', 'TRT', 'placebo', 'tinnitus-specific educational counseling (TC) and sound therapy (ST', 'TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC.\nMain Outcomes and Measures', 'Tinnitus retraining therapy (TRT', 'partial TRT']","['TQ score', 'TQ scores', 'mean change on the Tinnitus Questionnaire (TQ', 'changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS', 'TQ, TFI, or THI total scores', 'quality of life', 'Tinnitus-Related Quality of Life', 'partial TRT']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034380'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",44.0,0.343141,"Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Formby', 'Affiliation': 'Department of Communicative Disorders, University of Alabama, Tuscaloosa.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0821']
1248,30753672,Contribution of Liver Fat to Weight Loss-Induced Changes in Serum Hepatokines: A Randomized Controlled Trial.,"CONTEXT
Hepatokines have emerged as potential mediators of obesity-associated comorbidities, such as type 2 diabetes, cardiovascular disease, fractures, and central hypogonadism.
OBJECTIVE
To assess whether weight loss-induced changes in hepatokines are mediated by intrahepatic triglyceride (IHTG) content.
DESIGN
Cross-sectional study and randomized controlled trial.
SETTING
General community.
PARTICIPANTS
Metabolically healthy, lean men (waist <94 cm; n = 25) and men with abdominal obesity (waist 102 to 110 cm; n = 52).
INTERVENTION
Men with abdominal obesity were randomized to 8-week dietary weight loss or no weight loss.
MAIN OUTCOME MEASURES
IHTG and serum hepatokines, that is, serum IGF1, IGF binding protein 1 (IGFBP1), SHBG, fibroblast growth factor 21 (FGF21), fetuin A, and plasma fetuin B.
RESULTS
All hepatokines, except for fetuin B, were significantly different between lean men and men with obesity. After the weight-loss intervention (-10.3 kg; 95% CI, -11.4 to-9.2), serum IGF1, IGFBP1, SHBG, and fetuin A approached the values observed in lean men. Cross-sectional associations were observed between IHTG and IGF1 (β = -0.51; 95% CI, -0.82 to -0.20), IGFBP1 (β = -4.2; 95% CI, -7.7 to -0.7), and FGF21 (β = 2.1; 95% CI, 1.3 to 2.9) in lean men and men with abdominal obesity combined. Weight loss resulted in a reduction of IHTG (treatment effect, -2.2%; 95% CI, -3.4% to -1.2%) that was associated with a change in IGF1 (β = -0.9; 95% CI, -1.3 to -0.4), IGFBP1 (β = -0.17; 95% CI, -0.31 to -0.03), and SHBG levels (β = -0.18; 95% CI, -0.29 to -0.07). Mediation analyses showed that only the weight loss-induced change in serum IGF1 was mediated by IHTG (mediated effect, 32.7%; 95% CI, 4.6% to 79.2%).
CONCLUSIONS
Dietary weight loss has differential effects on hepatokines. This study shows that the change in serum IGF1 levels after dietary weight loss is mediated by the change in IHTG content.",2019,"Weight loss resulted in a reduction of IHTG (treatment effect, -2.2%; 95% CI, -3.4% to -1.2%) that was associated with a change in IGF1 (β = -0.9; 95% CI, -1.3 to -0.4), IGFBP1","['Men with abdominal obesity', 'General community', 'Metabolically healthy, lean men (waist <94 cm; n = 25) and men with abdominal obesity (waist 102 to 110 cm; n = 52', 'Serum Hepatokines']","['8-week dietary weight loss or no weight loss', 'IGFBP1']","['serum IGF1, IGFBP1, SHBG, and fetuin A', 'Weight loss', 'serum IGF1 levels', 'weight loss-induced change in serum IGF1', 'IHTG and serum hepatokines, that is, serum IGF1, IGF binding protein 1 (IGFBP1), SHBG, fibroblast growth factor 21 (FGF21), fetuin A, and plasma fetuin B', 'SHBG levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0051477', 'cui_str': 'AHSG Protein'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0123256', 'cui_str': 'IGFBP-1'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3203083', 'cui_str': 'Fetuin-Like Protein IRL685'}]",,0.163848,"Weight loss resulted in a reduction of IHTG (treatment effect, -2.2%; 95% CI, -3.4% to -1.2%) that was associated with a change in IGF1 (β = -0.9; 95% CI, -1.3 to -0.4), IGFBP1","[{'ForeName': 'Ine', 'Initials': 'I', 'LastName': 'Telgenkamp', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Yvo H A M', 'Initials': 'YHAM', 'LastName': 'Kusters', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Casper G', 'Initials': 'CG', 'LastName': 'Schalkwijk', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Alfons J H M', 'Initials': 'AJHM', 'LastName': 'Houben', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'M Eline', 'Initials': 'ME', 'LastName': 'Kooi', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Lindeboom', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Judith A P', 'Initials': 'JAP', 'LastName': 'Bons', 'Affiliation': 'Central Diagnostic Laboratory, Maastricht University Medical Center, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'Nicolaas C', 'Initials': 'NC', 'LastName': 'Schaper', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Joris', 'Affiliation': 'Top Institute of Food and Nutrition, Wageningen, Netherlands.'}, {'ForeName': 'Jogchum', 'Initials': 'J', 'LastName': 'Plat', 'Affiliation': 'School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Top Institute of Food and Nutrition, Wageningen, Netherlands.'}, {'ForeName': 'Coen D A', 'Initials': 'CDA', 'LastName': 'Stehouwer', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Martijn C G J', 'Initials': 'MCGJ', 'LastName': 'Brouwers', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, Netherlands.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02378']
1249,31140402,Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT.,"BACKGROUND
Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear.
OBJECTIVES
To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration.
DESIGN
A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation.
SETTING
Secondary care vascular centres in England.
PARTICIPANTS
Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks' and 6 months' duration and an ankle-brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux.
INTERVENTIONS
Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed).
MAIN OUTCOME MEASURES
The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis.
RESULTS
A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240-328] days in the early ablation group and 278 (IQR 175-324) days in the deferred endovenous ablation group ( p = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores ( p < 0.001), EuroQol-5 Dimensions index values ( p = 0.03) and Short Form questionnaire-36 items body pain ( p = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318; p = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs; p = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results.
LIMITATIONS
Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group.
CONCLUSIONS
Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective.
FUTURE WORK
Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN02335796.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 24. See the NIHR Journals Library website for further project information.",2019,"Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001].","['Secondary care vascular centres in England', 'A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation', ""Patients aged ≥\u200918 years with a venous leg ulcer of between 6 weeks' and 6 months' duration and an ankle-brachial pressure index of ≥\u20090.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux"", 'patients with venous ulceration']","['compression therapy with deferred endovenous ablation', 'compression therapy with early endovenous ablation of superficial venous reflux', 'Compression bandaging', 'early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed', 'endovenous ablation of superficial venous reflux']","['Aberdeen Varicose Vein Questionnaire scores', 'ulcer healing rate', 'EuroQol-5 Dimensions index values', 'pain and deep-vein thrombosis', 'Median time to ulcer healing', 'total costs', '24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs', 'technical success', 'Time to ulcer healing', 'time from randomisation to ulcer healing', 'clinical effectiveness and cost-effectiveness', 'healing rates', 'questionnaire-36 items body pain', 'QALY', 'time to healing of venous leg ulcers', 'recurrence rates', 'incremental cost-effectiveness ratio of early ablation', 'Median ulcer-free time']","[{'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C2242647', 'cui_str': 'Endovenous ablation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1276055', 'cui_str': 'ABPI - Ankle brachial pressure index'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0042344', 'cui_str': 'Venous Stasis Ulcers'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2242647', 'cui_str': 'Endovenous ablation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C1533146', 'cui_str': 'Compression bandaging'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}]","[{'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",450.0,0.0803441,"Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001].","[{'ForeName': 'Manjit S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Heatley', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bulbulia', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Cullum', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Epstein', 'Affiliation': 'Department of Applied Economics, University of Granada, Granada, Spain.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Nyamekye', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Poskitt', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renton', 'Affiliation': 'North West London Hospitals NHS Trust, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23240']
1250,31851351,Effect of Concurrent Chemoradiation With Celecoxib vs Concurrent Chemoradiation Alone on Survival Among Patients With Non-Small Cell Lung Cancer With and Without Cyclooxygenase 2 Genetic Variants: A Phase 2 Randomized Clinical Trial.,"Importance
Treatment of locally advanced non-small cell lung cancer (NSCLC) remains challenging. The rationale of combining a cyclooxygenase 2 (COX-2) inhibitor with concurrent chemoradiation (CCRT) was based on results of preclinical research and prospective clinical studies; however, no randomized clinical trial has provided evidence of a direct comparison with CCRT alone.
Objective
To determine the effect of combined selective COX-2 inhibition with standard CCRT on survival among patients with unresectable stage III NSCLC.
Design, Setting, and Participants
A single-center, open-label, randomized phase 2 clinical trial was performed among 96 patients who had histologically and cytologically confirmed unresectable stage III NSCLC. Participants were enrolled from November 2011 to August 2015. Data were analyzed from February to October 2018.
Intervention
Patients were randomized to receive thoracic radiation, 60 Gy, for 6 weeks concurrent with etoposide and cisplatin or the same regimen of CCRT combined with 200 mg of celecoxib, taken twice daily.
Main Outcomes and Measures
The primary end point was overall survival. The secondary end points were the proportion of patients with treatment-related toxic effects, progression-free survival, and overall survival in subgroups with and without the COX-2 genotype.
Results
A total of 100 patients were randomized. Following the exclusion of 4 outliers, 96 participants (96.0%) were analyzed (51 randomized to CCRT alone and 45 randomized to CCRT with celecoxib; mean [SD] age, 60.0 [8.3] years; 73.0 [76.0%] male). The median overall survival time was 32.8 (95% CI, 17.0-48.5) months in the group that received CCRT with celecoxib and 35.5 (95% CI, 25.8-45.2) months in the group that received CCRT alone (P = .88). Celecoxib with CCRT was well tolerated; the incidence of symptomatic radiation pneumonitis was 6.6% (95% CI, 1.4%-18.0%) in the group that received CCRT with celecoxib and 11.8% (95% CI, 4.4%-23.9%) in the group that received CCRT alone (P = .49). Among patients with the high-risk genotype, celecoxib plus CCRT was not associated with higher progression-free survival (hazard ratio, 0.36; 95% CI, 0.13-1.04; P = .05) or overall survival (hazard ratio, 0.50; 95% CI, 0.15-1.72; P = .26) compared with CCRT alone.
Conclusions and Relevance
In unresectable stage III NSCLC, adding celecoxib to concurrent chemoradiation did not improve survival. A smaller, not statistically significant proportion of patients in the CCRT with celecoxib group compared with the CCRT alone group developed symptomatic radiation pneumonitis. Among patients with the high-risk genotype, adding celecoxib to CCRT did not improve overall or progression-free survival.
Trial Registration
ClinicalTrials.gov identifier: NCT01503385.",2019,"Celecoxib with CCRT was well tolerated; the incidence of symptomatic radiation pneumonitis was 6.6% (95% CI, 1.4%-18.0%) in the group that received CCRT with celecoxib and 11.8% (95% CI, 4.4%-23.9%) in the group that received CCRT alone (P = .49).","['patients with unresectable stage III NSCLC', 'Patients With Non-Small Cell Lung Cancer', 'locally advanced non-small cell lung cancer (NSCLC', 'Participants were enrolled from November 2011 to August 2015', '96 participants (96.0%) were analyzed (51 randomized to', 'patients with the high-risk genotype', '100 patients were randomized', '96 patients who had histologically and cytologically confirmed unresectable stage III NSCLC', 'mean [SD] age, 60.0 [8.3] years; 73.0 [76.0%] male']","['celecoxib plus CCRT', 'celecoxib', 'CCRT with celecoxib', 'Concurrent Chemoradiation', 'thoracic radiation', 'CCRT', 'etoposide and cisplatin', 'Celecoxib', 'CCRT combined with 200 mg of celecoxib', 'celecoxib to CCRT', 'combined selective COX-2 inhibition with standard CCRT', 'Cyclooxygenase', 'cyclooxygenase 2 (COX-2) inhibitor with concurrent chemoradiation (CCRT', 'Celecoxib with CCRT']","['progression-free survival', 'proportion of patients with treatment-related toxic effects, progression-free survival, and overall survival', 'median overall survival time', 'overall survival', 'survival', 'symptomatic radiation pneumonitis', 'tolerated; the incidence of symptomatic radiation pneumonitis', 'overall or progression-free survival', 'Survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin H2 Synthetase'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0206063', 'cui_str': 'Pneumonia, Radiation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",96.0,0.39904,"Celecoxib with CCRT was well tolerated; the incidence of symptomatic radiation pneumonitis was 6.6% (95% CI, 1.4%-18.0%) in the group that received CCRT with celecoxib and 11.8% (95% CI, 4.4%-23.9%) in the group that received CCRT alone (P = .49).","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Bi', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zongmei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Dongfu', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhixue', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'QinFu', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhouguang', 'Initials': 'Z', 'LastName': 'Hui', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zefen', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jima', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiaozhen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lipin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Luhua', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center and Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18070']
1251,31743987,"Comparison of ultrasound-guided platelet-rich plasma, prolotherapy, and corticosteroid injections in rotator cuff lesions.","BACKGROUND
Injections are a good alternative to conventional treatment-resistant cases with rotator cuff (RC) lesions before operation. Currently, different injection methods are used in RC lesions.
OBJECTIVE
To evaluate the efficacy of different injection methods (platelet-rich plasma [PRP], corticosteroid [COR] and prolotherapy [PRO]) in RC tendon lesions.
METHODS
One hundred and twenty-nine patients were divided into 4 groups as PRP, COR, PRO and the lidocaine group. Subacromial injection was applied to all groups. They were evaluated using the Visual Analogue Scale (VAS), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), and Western Ontario Rotator Cuff Index (WORC) at 3, 12 and 24 weeks post-injection.
RESULTS
In the COR group in the 3rd week, VAS and WORC scores were significantly lower than the other groups (p< 0.01 and p< 0.05 respectively). In the PRP group in the 24th week, VAS and WORC scores were found to be significantly lower than the COR group (p< 0.01 and p< 0.05 respectively). In the COR group in the 3rd week the ASES score was found to be significantly higher than the PRP and PRO group (p< 0.01).
CONCLUSION
In patients with RC lesions, corticosteroid injection provides short-term relief for pain, function, and quality of life, while PRP injection works for long-term wellbeing. For all types of applied injections, improvement in pain, function and quality of life were observed.",2020,"In the COR group in the 3rd week the ASES score was found to be significantly higher than the PRP and PRO group (p< 0.01).
","['rotator cuff lesions', 'patients with RC lesions', 'One hundred and twenty-nine patients']","['corticosteroid injection', 'lidocaine', 'ultrasound-guided platelet rich plasma, prolotherapy, and corticosteroid injections', 'Subacromial injection', 'injection methods (platelet-rich plasma [PRP], corticosteroid [COR] and prolotherapy [PRO']","['Visual Analogue Scale (VAS), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), and Western Ontario Rotator Cuff Index (WORC', 'pain, function, and quality of life', 'pain, function and quality of life', 'ASES score', 'VAS and WORC scores']","[{'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0500223', 'cui_str': 'Proliferation Therapy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",129.0,0.0147443,"In the COR group in the 3rd week the ASES score was found to be significantly higher than the PRP and PRO group (p< 0.01).
","[{'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Sari', 'Affiliation': 'Erenkoy Physical Therapy and Rehabilitation Hospital, Physical Medicine and Rehabilitation Clinic, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Eroglu', 'Affiliation': 'Erenkoy Physical Therapy and Rehabilitation Hospital, Sports Medicine Clinic, Istanbul, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191519']
1252,31609689,Behavioral Activation for Promoting Well-Being in Mild Dementia: Feasibility and Outcomes of a Pilot Randomized Controlled Trial.,"Engaging in meaningful and enjoyable activities is an important contributor to well-being and maintaining good quality of life. There is a paucity of randomized controlled trials of interventions supporting people with mild dementia to engage in meaningful and purposeful activity. The aim of this study was to assess whether Behavioral Activation (BA) is an acceptable psychological intervention for people with mild dementia and whether a large-scale trial is feasible. Participants were randomly assigned to BA (n = 42) or treatment as usual (TAU) (n = 21). BA aimed at increasing engagement in enjoyable and meaningful activity, and preventing low mood. Follow-up was at 3 and 6 months. Assessors were blind to treatment allocation (trial registration number: ISRCTN75503960). Retention rate was above 80% at both assessment time points. Treatment acceptability and credibility were high. Depressive symptoms remained unchanged in both groups. There was evidence of improvement associated with BA for every day function (-3.92, 95% Confidence Interval (CI) -6.87 to -0.97), and engagement in meaningful and enjoyable activity (5.08, 95% CI 0.99 to 9.16) post-treatment (3 months) in comparison to TAU. Both carer-rated patient health-related quality of life (0.16, 95% CI 0.04 to 0.28) and physical health (11.31, 95% CI 2.03 to 20.59) showed evidence of improvement at 3 months. Improvements in meaningful and enjoyable activity were maintained at 6 months.BA for people with mild dementia is feasible and acceptable and may be associated with clinically significant changes in function and quality of life. A full scale randomized controlled trial of clinical effectiveness is now needed.",2019,"Both carer-rated patient health-related quality of life (0.16, 95% CI 0.04 to 0.28) and physical health (11.31, 95% CI 2.03 to 20.59) showed evidence of improvement at 3 months.","['Mild Dementia', 'people with mild dementia']","['Behavioral Activation (BA', 'Behavioral Activation', 'BA']","['physical health', 'meaningful and enjoyable activity', 'Depressive symptoms', 'quality of life', 'Confidence Interval (CI', 'Retention rate', 'function and quality of life']","[{'cui': 'C3494623', 'cui_str': 'Mild dementia'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.300321,"Both carer-rated patient health-related quality of life (0.16, 95% CI 0.04 to 0.28) and physical health (11.31, 95% CI 2.03 to 20.59) showed evidence of improvement at 3 months.","[{'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Orgeta', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Tuijt', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Phuong', 'Initials': 'P', 'LastName': 'Leung', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Elisabet Sole', 'Initials': 'ES', 'LastName': 'Verdaguer', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Gould', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'University College London, London, UK.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190696']
1253,31609693,Low-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex Enhances Recognition Memory in Alzheimer's Disease.,"BACKGROUND
The lack of effective pharmacological or behavioral interventions for memory impairments associated with Alzheimer's disease (AD) emphasizes the need for the investigation of approaches based on neuromodulation.
OBJECTIVE
This study examined the effects of inhibitory repetitive transcranial magnetic stimulation (rTMS) of prefrontal cortex on recognition memory in AD patients.
METHODS
In a first experiment, 24 mild AD patients received sham and real 1Hz rTMS over the left and right dorsolateral prefrontal cortex (DLPFC), in different sessions, between encoding and retrieval phases of a non-verbal recognition memory task. In a second experiment, another group of 14 AD patients underwent sham controlled repeated sessions of 1Hz rTMS of the right DLPFC across a two week treatment. Non-verbal recognition memory task was performed at baseline, at the end of the two weeks period and at a follow up of 1 month.
RESULTS
Right real rTMS significantly improved memory performance compared to right sham rTMS (p = 0.001). Left real rTMS left the memory performance unchanged as compared with left sham rTMS (p = 0.46). The two sham conditions did not differ between each other (p = 0.24). In the second experiment, AD patients treated with real rTMS showed an improvement of memory performance at the end of the two weeks treatment (p = 0.0009), that persisted at 1-month follow-up (p = 0.002).
CONCLUSION
These findings provide evidence that inhibitory rTMS over the right DLPFC can improve recognition memory function in AD patients. They also suggest the importance of a new approach of non-invasive brain stimulation as a promising treatment in AD.",2019,Left real rTMS left the memory performance unchanged as compared with left sham rTMS (p = 0.46).,"[""Alzheimer's Disease"", '24 mild AD patients received', ""memory impairments associated with Alzheimer's disease (AD"", 'AD patients']","['real rTMS', 'Low-Frequency Repetitive Transcranial Magnetic Stimulation', 'sham and real 1Hz rTMS', 'inhibitory repetitive transcranial magnetic stimulation (rTMS', 'behavioral interventions']","['memory performance', 'recognition memory function']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0479729,Left real rTMS left the memory performance unchanged as compared with left sham rTMS (p = 0.46).,"[{'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Turriziani', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Smirni', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Giuseppa Renata', 'Initials': 'GR', 'LastName': 'Mangano', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Zappalà', 'Affiliation': 'Unità di Neurologia Cognitiva e Riabilitazione, ARNAS Garibaldi, Catania, Italy.'}, {'ForeName': 'Andreina', 'Initials': 'A', 'LastName': 'Giustiniani', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cipolotti', 'Affiliation': 'Department of Neuropsychology, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Oliveri', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190888']
1254,31096064,On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization: A secondary analysis of the His-SYNC Pilot Trial.,"BACKGROUND
The His-SYNC pilot trial was the first randomized comparison between His bundle pacing in lieu of a left ventricular lead for cardiac resynchronization therapy (His-CRT) and biventricular pacing (BiV-CRT), but was limited by high rates of crossover.
OBJECTIVE
To evaluate the results of the His-SYNC pilot trial utilizing treatment-received (TR) and per-protocol (PP) analyses.
METHODS
The His-SYNC pilot was a multicenter, prospective, single-blinded, randomized, controlled trial comparing His-CRT vs BiV-CRT in patients meeting standard indications for CRT (eg, NYHA II-IV patients with QRS >120 ms). Crossovers were required based on prespecified criteria. The primary endpoints analyzed included improvement in QRS duration, left ventricular ejection fraction (LVEF), and freedom from cardiovascular (CV) hospitalization and mortality.
RESULTS
Among 41 patients enrolled (aged 64 ± 13 years, 38% female, LVEF 28%, QRS 168 ± 18 ms), 21 were randomized to His-CRT and 20 to BiV-CRT. Crossover occurred in 48% of His-CRT and 26% of BiV-CRT. The most common reason for crossover from His-CRT was inability to correct QRS owing to nonspecific intraventricular conduction delay (n = 5). Patients treated with His-CRT demonstrated greater QRS narrowing compared to BiV (125 ± 22 ms vs 164 ± 25 ms [TR], P < .001;124 ± 19 ms vs 162 ± 24 ms [PP], P < .001). A trend toward higher echocardiographic response was also observed (80 vs 57% [TR], P = .14; 91% vs 54% [PP], P = .078). No significant differences in CV hospitalization or mortality were observed.
CONCLUSIONS
Patients receiving His-CRT on-treatment demonstrated superior electrical resynchronization and a trend toward higher echocardiographic response than BiV-CRT. Larger prospective studies may be justifiable with refinements in patient selection and implantation techniques to minimize crossovers.",2019,"A trend toward higher echocardiographic response was also observed (80 vs 57% [TR], P = .14; 91% vs 54% [PP], P = .078).","['41 patients enrolled (aged 64 ± 13 years, 38% female, LVEF 28%, QRS 168 ± 18 ms', 'patients meeting standard indications for CRT (eg, NYHA II-IV patients with QRS >120 ms']","['His-CRT vs BiV-CRT', 'His-CRT', 'cardiac resynchronization therapy (His-CRT) and biventricular pacing (BiV-CRT', 'corrective His bundle pacing and biventricular pacing']","['CV hospitalization or mortality', 'QRS narrowing', 'QRS duration, left ventricular ejection fraction (LVEF), and freedom from cardiovascular (CV) hospitalization and mortality', 'echocardiographic response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0079031', 'cui_str': 'BIV'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2936372', 'cui_str': 'Atrio-Biventricular Pacing'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",41.0,0.0705746,"A trend toward higher echocardiographic response was also observed (80 vs 57% [TR], P = .14; 91% vs 54% [PP], P = .078).","[{'ForeName': 'Gaurav A', 'Initials': 'GA', 'LastName': 'Upadhyay', 'Affiliation': 'Center for Arrhythmia Care, The University of Chicago Medicine, Section of Cardiology, Department of Medicine, Pritzker School of Medicine, Chicago, Illinois (Study Coordinating Site).'}, {'ForeName': 'Pugazhendhi', 'Initials': 'P', 'LastName': 'Vijayaraman', 'Affiliation': 'Geisinger Heart Institute, Wilkes Barre, Pennsylvania.'}, {'ForeName': 'Hemal M', 'Initials': 'HM', 'LastName': 'Nayak', 'Affiliation': 'Center for Arrhythmia Care, The University of Chicago Medicine, Section of Cardiology, Department of Medicine, Pritzker School of Medicine, Chicago, Illinois (Study Coordinating Site).'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': 'Section of Cardiology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Gopi', 'Initials': 'G', 'LastName': 'Dandamudi', 'Affiliation': 'Section of Cardiology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Parikshit S', 'Initials': 'PS', 'LastName': 'Sharma', 'Affiliation': 'Section of Cardiology, Department of Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Moeen', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Advocate Heart Institute, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mandrola', 'Affiliation': 'Baptist Health Louisville, Louisville, Kentucky.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Genovese', 'Affiliation': 'Center for Arrhythmia Care, The University of Chicago Medicine, Section of Cardiology, Department of Medicine, Pritzker School of Medicine, Chicago, Illinois (Study Coordinating Site).'}, {'ForeName': 'Jess W', 'Initials': 'JW', 'LastName': 'Oren', 'Affiliation': 'Geisinger Heart Institute, Danville, Pennsylvania.'}, {'ForeName': 'Faiz A', 'Initials': 'FA', 'LastName': 'Subzposh', 'Affiliation': 'Geisinger Heart Institute, Wilkes Barre, Pennsylvania.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Aziz', 'Affiliation': 'Center for Arrhythmia Care, The University of Chicago Medicine, Section of Cardiology, Department of Medicine, Pritzker School of Medicine, Chicago, Illinois (Study Coordinating Site).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Beaser', 'Affiliation': 'Center for Arrhythmia Care, The University of Chicago Medicine, Section of Cardiology, Department of Medicine, Pritzker School of Medicine, Chicago, Illinois (Study Coordinating Site).'}, {'ForeName': 'Dalise', 'Initials': 'D', 'LastName': 'Shatz', 'Affiliation': 'Center for Arrhythmia Care, The University of Chicago Medicine, Section of Cardiology, Department of Medicine, Pritzker School of Medicine, Chicago, Illinois (Study Coordinating Site).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Besser', 'Affiliation': 'Center for Arrhythmia Care, The University of Chicago Medicine, Section of Cardiology, Department of Medicine, Pritzker School of Medicine, Chicago, Illinois (Study Coordinating Site).'}, {'ForeName': 'Roberto M', 'Initials': 'RM', 'LastName': 'Lang', 'Affiliation': 'Center for Arrhythmia Care, The University of Chicago Medicine, Section of Cardiology, Department of Medicine, Pritzker School of Medicine, Chicago, Illinois (Study Coordinating Site).'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Trohman', 'Affiliation': 'Section of Cardiology, Department of Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Bradley P', 'Initials': 'BP', 'LastName': 'Knight', 'Affiliation': 'Section of Cardiology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Tung', 'Affiliation': 'Center for Arrhythmia Care, The University of Chicago Medicine, Section of Cardiology, Department of Medicine, Pritzker School of Medicine, Chicago, Illinois (Study Coordinating Site). Electronic address: rodericktung@uchicago.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Heart rhythm,['10.1016/j.hrthm.2019.05.009']
1255,31110051,Sodium Zirconium Cyclosilicate among Individuals with Hyperkalemia: A 12-Month Phase 3 Study.,"BACKGROUND AND OBJECTIVES
Oral sodium zirconium cyclosilicate (formerly ZS-9) binds and removes potassium via the gastrointestinal tract. Sodium zirconium cyclosilicate-associated restoration and maintenance of normokalemia and adverse events were evaluated in a two-part, open label, phase 3 trial.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS
In the correction phase, adult outpatients with plasma potassium ≥5.1 mmol/L (i-STAT Point-of-Care) received sodium zirconium cyclosilicate 10 g three times daily for 24-72 hours until normokalemic (potassium =3.5-5.0 mmol/L). Qualifying participants entered the ≤12-month maintenance phase and received sodium zirconium cyclosilicate 5 g once daily titrated to maintain normokalemia without dietary or medication restrictions. Prespecified primary end points were restoration of normal serum potassium values (3.5-5.0 mmol/L) during the correction phase and maintenance of serum potassium ≤5.1 mmol/L during the maintenance phase. Adverse events were assessed throughout.
RESULTS
Of 751 participants, 746 (99%) achieved normokalemia during the correction phase (mean serum potassium =4.8 mmol/L; 95% confidence interval, 4.7 to 4.8) and entered the maintenance phase; 466 (63%) participants completed the 12-month trial. Participants were predominantly white, men, and age ≥65 years old; 74% had an eGFR<60 ml/min per 1.73 m 2 , and 65% used renin-angiotensin-aldosterone system inhibitors. Mean time on sodium zirconium cyclosilicate was 286 days. Mean daily sodium zirconium cyclosilicate dose was 7.2 g (SD=2.6). Over months 3-12, mean serum potassium was 4.7 mmol/L (95% confidence interval, 4.6 to 4.7); mean serum potassium values ≤5.1 and ≤5.5 mmol/L were achieved by 88% and 99% of participants, respectively. Of 483 renin-angiotensin-aldosterone system inhibitor users at baseline, 87% continued or had their dose increased; 11% discontinued. Among 263 renin-angiotensin-aldosterone system inhibitor-naïve participants, 14% initiated renin-angiotensin-aldosterone system inhibitor therapy. Overall, 489 (66%) participants experienced adverse events during the maintenance phase, and 22% experienced a serious adverse event. Of eight (1%) deaths, none were considered related to sodium zirconium cyclosilicate. Nine (1%) and 34 (5%) participants experienced serum potassium <3.0 and 3.0-3.4 mmol/L, respectively.
CONCLUSIONS
After achieving normokalemia, individualized once daily sodium zirconium cyclosilicate was associated with maintenance of normokalemia without substantial renin-angiotensin-aldosterone system inhibitor changes for ≤12 months.",2019,"Over months 3-12, mean serum potassium was 4.7 mmol/L (95% confidence interval, 4.6 to 4.7); mean serum potassium values ≤5.1 and ≤5.5 mmol/L were achieved by 88% and 99% of participants, respectively.","['Participants were predominantly white, men, and age ≥65 years old; 74% had an eGFR<60 ml/min per 1.73 m 2 , and 65% used renin-angiotensin-aldosterone system inhibitors', '263 renin-angiotensin-aldosterone system inhibitor-naïve participants, 14% initiated renin-angiotensin-aldosterone system inhibitor therapy', 'Of 751 participants, 746 (99%) achieved normokalemia during the correction phase (mean serum potassium =4.8 mmol/L; 95% confidence interval, 4.7 to 4.8) and entered the maintenance phase; 466 (63%) participants completed the 12-month trial', 'Individuals with Hyperkalemia', 'adult outpatients with plasma potassium ≥5.1 mmol/L (i-STAT Point-of-Care']","['Sodium Zirconium Cyclosilicate', 'sodium zirconium cyclosilicate', 'sodium zirconium cyclosilicate 5 g once daily titrated to maintain normokalemia without dietary or medication restrictions']","['Mean time on sodium zirconium cyclosilicate', 'mean serum potassium values', 'serious adverse event', 'Adverse events', 'adverse events', 'mean serum potassium', 'restoration of normal serum potassium values', 'serum potassium']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0858155', 'cui_str': 'Plasma potassium'}, {'cui': 'C0205548', 'cui_str': 'Stat (qualifier value)'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}]","[{'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]",751.0,0.0312914,"Over months 3-12, mean serum potassium was 4.7 mmol/L (95% confidence interval, 4.6 to 4.7); mean serum potassium values ≤5.1 and ≤5.5 mmol/L were achieved by 88% and 99% of participants, respectively.","[{'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Spinowitz', 'Affiliation': 'Division of Nephrology, Department of Medicine, New York-Presbyterian Queens, New York, New York; bss9001@nyp.org.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, Texas.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Roger', 'Affiliation': 'Renal Research, Gosford, Australia.'}, {'ForeName': 'Edgar V', 'Initials': 'EV', 'LastName': 'Lerma', 'Affiliation': 'Section of Nephrology, Advocate Christ Medical Center, University of Illinois at Chicago, Oak Lawn, Illinois.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, Mississippi.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'von Haehling', 'Affiliation': 'Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Adler', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Bhupinder', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'ZS Pharma, Inc. (part of AstraZeneca), San Mateo, California.'}, {'ForeName': 'Philip T', 'Initials': 'PT', 'LastName': 'Lavin', 'Affiliation': 'Boston Biostatistics Research Foundation, Framingham, Massachusetts.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'McCullough', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Packham', 'Affiliation': 'Melbourne Renal Research Group, Reservoir Private Hospital, Reservoir, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.12651018']
1256,31120118,Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial.,"AIMS
To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban.
METHODS AND RESULTS
We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%).
CONCLUSION
Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.",2020,The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment.,"['From May 2014 through June 2018, consecutive patients were enrolled in seven countries', 'patients with acute low-risk PE (EudraCT Identifier 2013-001657-28', 'patients with acute low-risk PE', 'patients with low-risk pulmonary embolism with the']","['oral factor Xa inhibitor rivaroxaban', 'rivaroxaban', 'Rivaroxaban']","['Major bleeding', 'absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities', 'suffered symptomatic non-fatal VTE recurrence', 'symptomatic recurrent venous thromboembolism (VTE) or PE-related death', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4553708', 'cui_str': 'Factor Xa inhibitor'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0242707', 'cui_str': 'Right Ventricular Dysfunction'}, {'cui': 'C0729936', 'cui_str': 'Intracardiac (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.198423,The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment.,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barco', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schmidtmann', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center Mainz, Obere Zahlbacher Strasse 69, 55131 Mainz, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery, Research Center on Thromboembolic Diseases and Antithrombotic Therapies, University of Insubria, Viale Luigi Borri 57, 21100 Varese, Italy.'}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Vascular Medicine, Klinikum Darmstadt, Grafenstrasse 9, 64283 Darmstadt, Germany.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Becattini', 'Affiliation': 'Internal and Cardiovascular Medicine - Stroke Unit, University of Perugia, Via G. Dottori 1, 06129 Perugia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Bernardi', 'Affiliation': 'Department of Emergency Medicine, ULSS n.7, Via Brigata Bisagno 4, 31015 Conegliano (Treviso), Italy.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beyer-Westendorf', 'Affiliation': 'Thrombosis Research Unit, Division of Hematology, Department of Medicine I, University Hospital ""Carl Gustav Carus"", Fetscherstrasse 74, 01307 Dresden, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bonacchini', 'Affiliation': ""S.C. Medicina d'Urgenza e Pronto Soccorso, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell'Ospedale Maggiore 3, 20162 Milano, Italy.""}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brachmann', 'Affiliation': 'II Medical Department, Coburg Hospital, Ketschendorfer Strasse 33, 96450 Coburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christ', 'Affiliation': 'Emergency Care (Notfallzentrum), Luzerner Kantonsspital, 6000 Luzern, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Czihal', 'Affiliation': 'Division of Vascular Medicine, Hospital of the Ludwig-Maximilians-University, Georgenstrasse 5, 80799 Munich, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duerschmied', 'Affiliation': 'Department of Cardiology and Angiology I, Heart Center, Faculty of Medicine, University of Freiburg, Hugstetter Strasse 55, 79106 Freiburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Empen', 'Affiliation': 'Department of Internal Medicine, University Medical Center, Fleischmannstrasse 6, 17489 Greifswald, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Espinola-Klein', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ficker', 'Affiliation': 'Department of Respiratory Medicine, Nuremberg General Hospital/Paracelsus Medical University, Prof.-Ernst-Nathan-Strasse 1, 90419 Nuremberg, Germany.'}, {'ForeName': 'Cândida', 'Initials': 'C', 'LastName': 'Fonseca', 'Affiliation': 'Department of Internal Medicine, Hospital S. Francisco Xavier/CHLO, NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Campo Mártires da Pátria 130, 1169-056 Lisbon, Portugal.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Genth-Zotz', 'Affiliation': 'Department of Internal Medicine I, Katholisches Klinikum Mainz, An der Goldrube 11, 55131 Mainz, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jiménez', 'Affiliation': 'Respiratory Department, Ramón y Cajal Hospital, Universidad de Alcala, IRYCIS, Ctra. Colmenar Viejo, km. 9, 100, 28034 Madrid, Spain.'}, {'ForeName': 'Veli-Pekka', 'Initials': 'VP', 'LastName': 'Harjola', 'Affiliation': 'Emergency Medicine, University of Helsinki, Department of Emergency Medicine and Services, Helsinki University Hospital, Tukholmankatu 8A, 00290 Helsinki, Finland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Held', 'Affiliation': 'Department of Internal Medicine, Medical Mission Hospital, Academic Teaching Hospital of the Julius-Maximilian University of Wuerzburg, Josef-Schneider-Strasse 2, 97080 Wuerzburg, Germany.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Iogna Prat', 'Affiliation': 'Department of Emergency Medicine, Santa Maria della Misericordia Hospital, Piazzale Santa Maria della Misericordia 15, 33100 Udine, Italy.'}, {'ForeName': 'Tobias J', 'Initials': 'TJ', 'LastName': 'Lange', 'Affiliation': 'Department of Internal Medicine II, Division of Pneumology, University Medical Center Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Manolis', 'Affiliation': ""Department of Cardiology, General Hospital 'Asklepeion Voulas', Leof. Vasileos Pavlou 1, 166 73 Athens, Greece.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Kliniken Maria Hilf, Klinik für Pneumologie, Krankenhaus St. Franziskus, Viersener Str. 450, 41063 Mönchengladbach, Germany.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Mustonen', 'Affiliation': 'Department of Medicine, Keski-Suomi Central Hospital and University of Jyväskylä, Keskussairaalantie 19, 40620 Jyväskylä, Finland.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Rauch-Kroehnert', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin, Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany; German Center for Cardiovascular Research (DZHK), Berlin, Germany.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Ruiz-Artacho', 'Affiliation': 'Emergency Department, Clinico San Carlos Hospital, IdISSC, alle del Prof Martín Lagos, s/n, 28040 Madrid, Spain.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schellong', 'Affiliation': 'Vascular Center, Municipal Hospital of Dresden-Friedrichstadt, Friedrichstraße 41, 01067 Dresden, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schwaiblmair', 'Affiliation': 'Department of Cardiology, Respiratory Medicine and Intensive Care, Klinikum Augsburg, Ludwig-Maximilians-University Munich, Stenglinstrasse 2, 86156 Munich, Germany.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Stahrenberg', 'Affiliation': 'Helios Albert-Schweitzer-Klinik, Albert-Schweitzer-Weg 1, 37154 Northeim, Germany.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Westerweel', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Albert Schweitzerplaats 25, 3318 AT Dordrecht, The Netherlands.'}, {'ForeName': 'Philipp S', 'Initials': 'PS', 'LastName': 'Wild', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': 'Stavros V', 'Initials': 'SV', 'LastName': 'Konstantinides', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Lankeit', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehz367']
1257,31585686,Examining patterns of dose response for clients who do and do not complete cognitive processing therapy.,"Trauma-focused therapies, including Cognitive Processing Therapy (CPT; Resick et al., 2016), are effective at reducing clients' PTSD symptoms. A limitation to these treatments, however, is client completion of them. The current study examined temporal patterns of treatment non-completion and the relationships among non-completion, PTSD, and overall mental health functioning outcomes, among clients in a randomized controlled CPT implementation trial. Two models of symptom change were tested: 1) dose-effect model (i.e., clients uniformly improve with additional sessions at a negatively accelerating rate); and 2) the good-enough level model (i.e., clients remain in therapy until they have achieved sufficient improvement, thus clients who attend fewer sessions improve at quicker rates). Results indicated that 42% of clients did not complete treatment, with most discontinuing between sessions two and five. Data did not fit the dose-effect or good-enough level model. Rather, clients who improved at a greater rate in their PTSD symptoms and overall mental health functioning attended more sessions. The average client had the best outcomes when they completed all 12 sessions. Identifying clients who may be at risk for discontinuing treatment, and making a concerted effort toward retaining them, is imperative to reduce non-completion rates and ultimately improve client outcomes.",2019,"Rather, clients who improved at a greater rate in their PTSD symptoms and overall mental health functioning attended more sessions.",['clients who do and do not complete cognitive processing therapy'],[],['PTSD symptoms and overall mental health functioning'],"[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0194681,"Rather, clients who improved at a greater rate in their PTSD symptoms and overall mental health functioning attended more sessions.","[{'ForeName': 'Samantha C', 'Initials': 'SC', 'LastName': 'Holmes', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, United States; University of Akron, Department of Psychology, United States.'}, {'ForeName': 'Clara M', 'Initials': 'CM', 'LastName': 'Johnson', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, United States.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Suvak', 'Affiliation': 'Suffolk University, Department of Psychology, United States.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Sijercic', 'Affiliation': 'Ryerson University, Department of Psychology, Canada.'}, {'ForeName': 'Candice M', 'Initials': 'CM', 'LastName': 'Monson', 'Affiliation': 'Ryerson University, Department of Psychology, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wiltsey Stirman', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, United States; Stanford University, Department of Psychiatry and Behavioral Sciences, United States. Electronic address: sws1@stanford.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102120']
1258,31136218,High-intensity exercise training enhances mitochondrial oxidative phosphorylation efficiency in a temperature-dependent manner in human skeletal muscle: implications for exercise performance.,"The purpose of the present study was to investigate whether exercise training-induced adaptations in human skeletal muscle mitochondrial bioenergetics are magnified under thermal conditions resembling sustained intense contractile activity and whether training-induced changes in mitochondrial oxidative phosphorylation (OXPHOS) efficiency influence exercise efficiency. Twenty healthy men performed 6 wk of high-intensity exercise training [ i.e. , speed endurance training (SET; n = 10)], or maintained their usual lifestyle ( n = 10). Before and after the intervention, mitochondrial respiratory function was determined ex vivo in permeabilized muscle fibers under experimentally-induced normothermia (35°C) and hyperthermia (40°C) mimicking in vivo muscle temperature at rest and during intense exercise, respectively. In addition, activity and content of muscle mitochondrial enzymes and proteins were quantified. Exercising muscle efficiency was determined in vivo by measurements of leg hemodynamics and blood parameters during one-legged knee-extensor exercise. SET enhanced maximal OXPHOS capacity and OXPHOS efficiency at 40°C, but not at 35°C, and attenuated hyperthermia-induced decline in OXPHOS efficiency. Furthermore, SET increased expression of markers of mitochondrial content and up-regulated content of MFN2, DRP1, and ANT1. Also, SET improved exercise efficiency and capacity. These findings indicate that muscle mitochondrial bioenergetics adapts to high-intensity exercise training in a temperature-dependent manner and that enhancements in mitochondrial OXPHOS efficiency may contribute to improving exercise performance.-Fiorenza, M., Lemminger, A. K., Marker, M., Eibye, K., Iaia, F. M., Bangsbo, J., Hostrup, M. High-intensity exercise training enhances mitochondrial oxidative phosphorylation efficiency in a temperature-dependent manner in human skeletal muscle: implications for exercise performance.",2019,"Furthermore, SET increased expression of markers of mitochondrial content and up-regulated content of MFN2, DRP1, and ANT1.","['human skeletal muscle', 'Twenty healthy men']","['exercise training-induced adaptations', 'intensity exercise training', 'high-intensity exercise training [ i.e. , speed endurance training (SET; n = 10)], or maintained their usual lifestyle (CON', 'High-intensity exercise training']","['Exercising muscle efficiency', 'maximal OXPHOS capacity and OXPHOS efficiency', 'exercise efficiency and capacity', 'expression of markers of mitochondrial content and up-regulated content of MFN2, DRP1, and ANT1']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",20.0,0.0178478,"Furthermore, SET increased expression of markers of mitochondrial content and up-regulated content of MFN2, DRP1, and ANT1.","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Fiorenza', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders K', 'Initials': 'AK', 'LastName': 'Lemminger', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Marker', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Eibye', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'F Marcello', 'Initials': 'FM', 'LastName': 'Iaia', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hostrup', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.201900106RRR']
1259,31048088,Vitamin D supplementation for prevention of cancer: The D2d cancer outcomes (D2dCA) study.,"Evidence on biological plausibility from mechanistic studies and data from observational studies suggest that vitamin D may be linked to risk of several types of cancer. However, evidence from clinical trials evaluating the effect of vitamin D supplementation on cancer risk is limited. The Vitamin D and Type 2 Diabetes (D2d) study is a multi-center, randomized, placebo-controlled clinical trial conducted to examine the causal relationship between oral vitamin D supplementation and development of diabetes among overweight adults with prediabetes. The D2d study provides a unique opportunity to assess the effect of vitamin D supplementation at a higher dose (4000 IU/day) than has been used in other clinical trials with cancer outcomes, in a population at higher than average risk for cancer. This paper provides: Krishnan and Feldman (2011) a) baseline characteristics of the D2d population included in the D2d cancer outcomes secondary study (D2dCA) and comparison to other large trials of vitamin D supplementation and cancer risk; Leyssens et al. (2013) b) description of data that are being collected during the trial and the planned statistical analyses to test whether vitamin D supplementation at a dose of 4000 IU/day has an effect on incident cancer overall, on incidence of certain types of cancer, and on incidence of precancerous lesions. Results of D2dCA will help guide future research and clinical recommendations related to vitamin D and cancer risk.",2019,"The D2d study provides a unique opportunity to assess the effect of vitamin D supplementation at a higher dose (4000 IU/day) than has been used in other clinical trials with cancer outcomes, in a population at higher than average risk for cancer.",['diabetes among overweight adults with prediabetes'],"['vitamin D', 'vitamin D supplementation', 'placebo', 'Vitamin D', 'Vitamin D supplementation', 'oral vitamin D supplementation', 'D2dCA']",[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",[],,0.291078,"The D2d study provides a unique opportunity to assess the effect of vitamin D supplementation at a higher dose (4000 IU/day) than has been used in other clinical trials with cancer outcomes, in a population at higher than average risk for cancer.","[{'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Chatterjee', 'Affiliation': 'Division of General Internal Medicine, 200 Morris Street, 3(rd) Floor, Box 104427, Durham, NC 27701, USA. Electronic address: ranee.chatterjee@duke.edu.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Erban', 'Affiliation': 'Cancer Center, Tufts Medical Center, 800 Washington St, Box 245, Boston, MA 02111, USA. Electronic address: JErban@tuftsmedicalcenter.org.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fuss', 'Affiliation': 'Division of Endocrinology, Tufts Medical Center, 800 Washington Street, Box 268, Boston, MA 02111, USA. Electronic address: pfuss@tuftsmedicalcenter.org.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Dolor', 'Affiliation': 'Division of General Internal Medicine, 200 Morris Street, 3(rd) Floor, Box 104427, Durham, NC 27701, USA. Electronic address: rowena.dolor@duke.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'LeBlanc', 'Affiliation': 'Kaiser Permanente Center for Health Research NW, 3800 N Interstate, Portland, OR 97229, USA. Electronic address: Erin.s.leblanc@kpchr.org.'}, {'ForeName': 'Myrlene', 'Initials': 'M', 'LastName': 'Staten', 'Affiliation': 'Kelly Government Services for the National Institute of Diabetes and Digestive and Kidney Diseases, 6701 Democracy Boulevard, Room 6107, Bethesda, MD 20817, USA. Electronic address: statenm@niddk.nih.gov.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sheehan', 'Affiliation': 'Spaulding Rehabilitation Network, 300 1(st) Ave, Charlestown, MA 02129, USA. Electronic address: prsheehan@partners.org.'}, {'ForeName': 'Anastassios', 'Initials': 'A', 'LastName': 'Pittas', 'Affiliation': 'Division of Endocrinology, Tufts Medical Center, 800 Washington Street, Box 268, Boston, MA 02111, USA. Electronic address: apittas@tuftsmedicalcenter.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.04.015']
1260,31454258,Language Comprehension After Mild Traumatic Brain Injury: The Role of Speed.,"Purpose The aim of this study was to characterize language comprehension in mild traumatic brain injury (mTBI) by testing a speed-based hypothesis. We hypothesized that adults with mTBI would perform worse than a group of adults with orthopedic injuries (OIs) on an experimental language comprehension task. Method The study employed a prospective experimental design. Participants were 19 adults with mTBI and 19 adults with OI ages 18-55 years. Participants completed the Whatdunit task, a sentence agent selection task in speeded and unspeeded conditions. Results In the unspeeded condition, the mTBI group performed with a marginally significant higher accuracy than the OI group. In the speeded condition, the mTBI group performed with lower accuracy than the OI group; however, this difference did not reach statistical significance. There was a marginally significant interaction of Sentence Type × Group for reaction time in the speeded condition. Conclusions While our task might have been sensitive to cognitive processing abilities in both groups (as evidenced by the main effects of condition and sentence type), the task was not specific enough to capture mTBI-related deficits. The similarities in performance between both groups have clinical implications for the treatment of not just brain-related trauma but also trauma in general.",2019,"In the unspeeded condition, the mTBI group performed with a marginally significant higher accuracy than the OI group.","['Participants were 19 adults with mTBI and 19 adults with OI ages 18-55 years', 'After Mild Traumatic Brain Injury', 'adults with mTBI', 'mild traumatic brain injury (mTBI']",[],['Language Comprehension'],"[{'cui': 'C0386744', 'cui_str': 'AM19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}]",[],"[{'cui': 'C0233733', 'cui_str': 'Language comprehension, function (observable entity)'}]",19.0,0.0333262,"In the unspeeded condition, the mTBI group performed with a marginally significant higher accuracy than the OI group.","[{'ForeName': 'Rocío S', 'Initials': 'RS', 'LastName': 'Norman', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin-Madison.'}, {'ForeName': 'Manish N', 'Initials': 'MN', 'LastName': 'Shah', 'Affiliation': 'Berbee Walsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin-Madison.'}, {'ForeName': 'Lyn S', 'Initials': 'LS', 'LastName': 'Turkstra', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin-Madison.'}]",American journal of speech-language pathology,['10.1044/2019_AJSLP-18-0203']
1261,31207232,Guselkumab Efficacy after Withdrawal Is Associated with Suppression of Serum IL-23-Regulated IL-17 and IL-22 in Psoriasis: VOYAGE 2 Study.,"BACKGROUND
Guselkumab selectively inhibits IL-23 and in psoriasis, produces high clinical responses, including durable maintenance after treatment withdrawal in some patients. The relationships between IL-23 blockade, serum markers downstream of IL-23 signaling, and withdrawal were explored with guselkumab in VOYAGE 2.
METHODS
At week 28, patients with ≥90% Psoriasis Area and Severity Index improvement from baseline (PASI 90) were rerandomized to withdrawal and received placebo (n = 182), or maintenance therapy (n = 193). The guselkumab withdrawal group reinitiated guselkumab upon loss of ≥50% of week- 28 PASI improvement or by week 72. Cytokine changes associated with psoriasis recurrence (serum IL-17A, IL-17F, IL-22, and IL-23) after withdrawal were evaluated.
RESULTS
Efficacy in the guselkumab maintenance group was sustained through week 72, whereas efficacy diminished in the guselkumab withdrawal group (PASI 90, 86.0% vs. 11.5%). After 20 weeks of retreatment, 80.4% of guselkumab withdrawal patients achieved PASI 90 responses versus baseline. Maintenance of response after withdrawal was associated with suppression of IL-17A, IL-17F, and IL-22. Increases in cytokine levels had poor predictive power for psoriasis reoccurrence as these increases lagged behind increases in PASI scores.
CONCLUSION
Upon guselkumab withdrawal, most patients lost clinical response and regained responses with retreatment. Correlation of IL-23 signaling serum cytokines increased with disease recurrence, supporting the role of IL-23 in expansion and maintenance of CD4+ T helper type 17, T helper type 22, and related CD8+ T-cell subsets producing IL-17A, IL-17F, and IL-22.",2019,"Maintenance of response following withdrawal was associated with suppression of IL-17A, IL-17F and IL-22.",[],['placebo'],"['psoriasis recurrence (serum IL-17A, IL-17F, IL-22, and IL-23', 'PASI 90 responses', 'PASI scores']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C1705097', 'cui_str': 'Interleukin-17F'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0857612,"Maintenance of response following withdrawal was associated with suppression of IL-17A, IL-17F and IL-22.","[{'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia; Probity Medical Research Inc., Skin & Cancer Foundation Inc., Carlton, Victoria, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Yaung-Kaung', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Ernesto J', 'Initials': 'EJ', 'LastName': 'Muñoz-Elías', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Branigan', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Skinflammation Center, Hamburg, Germany; Dermatologikum Berlin, Berlin, Germany. Electronic address: k.reich@uke.de.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.05.016']
1262,31107324,Can the QuickDASH PROM be Altered by First Completing the Tasks on the Instrument?,"BACKGROUND
Health systems and payers use patient-reported outcome measures (PROMs) to inform quality improvement and value-based payment models. Although it is known that psychosocial factors and priming influence PROMs, we sought to determine the effect of having patients complete functional tasks before completing the PROM questionnaire, which has not been extensively evaluated.
QUESTIONS/PURPOSES
(1) Will QuickDASH scores change after patients complete the tasks on the questionnaire compared with baseline QuickDASH scores? (2) Will the change in QuickDASH score in an intervention (task completion) group be different than that of a control group? (3) Will a higher proportion of patients in the intervention group than those in the control group improve their QuickDASH scores by greater than a minimally clinically important difference (MCID) of 14 points?
METHODS
During a 2-month period, 140 patients presented at our clinic with a hand or upper-extremity problem. We approached patients who spoke and read English and were 18 years old or older. One hundred thirty-two (94%) patients met the inclusion criteria and agreed to participate (mean ± SD age, 52 ± 17 years; 60 men [45%], 72 women [55%]; 112 in the intervention group [85%] and 20 in the control group [15%]). First, all patients who completed the QuickDASH PROM (at baseline) were recruited for participation. Intervention patients completed the functional tasks on the QuickDASH and completed a followup QuickDASH. Control patients were recruited and enrolled after the intervention group completed the study. Participants in the control group completed the QuickDASH at baseline and a followup QuickDASH 5 minutes after (the time required to complete the functional tasks). Paired and unpaired t-tests were used to evaluate the null hypotheses that (1) QuickDASH scores for the intervention group would not change after the tasks on the instrument were completed and (2) the change in QuickDASH score in the intervention group would not be different than that of the control group (p < 0.05). To evaluate the clinical importance of the change in score after tasks were completed, we recorded the number of patients with a change greater than an MCID of 14 points on the QuickDASH. Fisher's exact test was used to evaluate the difference between groups in those reaching an MCID of 14.
RESULTS
In the intervention group, the QuickDASH score decreased after the intervention (39 ± 24 versus 25 ± 19; mean difference, -14 points [95% CI, 12 to 16]; p < 0.001). The change in QuickDASH scores was greater in the intervention group than that in the control group (-14 ± 11 versus -2 ± 9 [95% CI, -17 to -7]; p < 0.001). A larger proportion of patients in the intervention group than in the control group demonstrated an improvement in QuickDASH scores greater than the 14-point MCID ([43 of 112 [38%] versus two of 20 [10%]; odds ratio, 5.4 [95% CI, 1 to 24%]; p = 0.019).
CONCLUSIONS
Reported disability can be reduced, thereby improving PROMs, if patients complete QuickDASH tasks before completing the questionnaire. Modifiable factors that influence PROM scores and the context in which scores are measured should be analyzed before PROMs are broadly implemented into reimbursement models and quality measures for orthopaedic surgery. Standardizing PROM administration can limit the influence of context, such as task completion, on outcome scores and should be used in value-based payment models.
LEVEL OF EVIDENCE
Level II, therapeutic study.",2019,"A larger proportion of patients in the intervention group than in the control group demonstrated an improvement in QuickDASH scores greater than the 14-point MCID ([43 of 112 [38%] versus two of 20 [10%]; odds ratio, 5.4 [95% CI, 1 to 24%]; p = 0.019).
","['One hundred thirty-two (94%) patients met the inclusion criteria and agreed to participate (mean ± SD age, 52 ± 17 years; 60 men [45%], 72 women [55%]; 112 in the intervention group [85%] and 20 in the control group [15', 'Control patients were recruited and enrolled after the intervention group completed the study', '140 patients presented at our clinic with a hand or upper-extremity problem', 'patients who completed the QuickDASH PROM (at baseline) were recruited for participation', 'patients with a change greater than an MCID of 14 points on the QuickDASH', 'patients who spoke and read English and were 18 years old or older']",['QuickDASH'],"['QuickDASH score', 'null hypotheses that (1) QuickDASH scores', 'QuickDASH scores', 'functional tasks', 'change in QuickDASH scores']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1277154', 'cui_str': 'Reads English'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456148', 'cui_str': 'Null (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",140.0,0.0500028,"A larger proportion of patients in the intervention group than in the control group demonstrated an improvement in QuickDASH scores greater than the 14-point MCID ([43 of 112 [38%] versus two of 20 [10%]; odds ratio, 5.4 [95% CI, 1 to 24%]; p = 0.019).
","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Shapiro', 'Affiliation': 'L. M. Shapiro, S. L. Eppler, R. N. Kamal, Stanford University, VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford, CA, USA A. H. S. Harris , Stanford School of Medicine/VA Palo Alto Healthcare System, Department of Surgery, Stanford, CA, USA.'}, {'ForeName': 'Alex H S', 'Initials': 'AHS', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Eppler', 'Affiliation': ''}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000731']
1263,31102438,Longitudinal Clinical Trial Recruitment and Retention Challenges in the Burn Population: Lessons Learned From a Trial Examining a Novel Intervention for Chronic Neuropathic Symptoms.,"Long-term trials are key to understanding chronic symptoms such as pain and itch. However, challenges such as high attrition rates and poor recruitment are common when conducting research. The aim of this work was to explore these issues within a long-term randomized control trial using transcranial direct current stimulation to treat pain and itch. This parallel double blinded, placebo-controlled randomized trial was comprised of 15 transcranial direct current stimulation visits and 7 follow-up visits. Participants were over the age of 18, had a burn injury that occurred at least 3 weeks before enrollment, and reported having pain and/or itch that was moderate to severe in intensity. A total of 31 subjects were randomized into either an active or sham transcranial direct current stimulation groups. There were no significant differences between the groups in terms of age, race, education, baseline depression, or anxiety. The median dropout time was at visit 19 (visit 16 [SE = 1.98] for the sham group and visit 19 [SE = 1.98] for the active group). Analysis showed no differences in the dropout rate between groups [χ2(1) = 0.003, P = .954]. The dropout rate was 46.7% for the sham group and 43.8% for the active group. Overall, 45.2% of the subjects dropped out of the trial. Long-term clinical trials are an essential part of evaluating interventions for symptoms such as chronic pain and itch. However, as seen in this trial, long-term studies in the burn population often face recruitment and adherence challenges.",2019,"Analysis showed no differences in the dropout rate between groups (χ2(1)=0.003, p=0.954).","['31 subjects', 'Participants were over the age of 18, had a burn injury that occurred at least 3 weeks prior to enrollment, and reported having pain']","['15 transcranial direct current stimulation visits and 7 follow-up visits', 'transcranial direct current stimulation', 'placebo', 'active or sham transcranial direct current stimulation groups']","['dropout rate', 'median dropout time', 'age, race, education, baseline depression, or anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",31.0,0.630943,"Analysis showed no differences in the dropout rate between groups (χ2(1)=0.003, p=0.954).","[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Ohrtman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Boston-Harvard Burn Injury Model System, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Zaninotto', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Carvalho', 'Affiliation': 'Neurotherapeutics and Experimental Psychopathology (NEP) Group, Psychological Neuroscience Lab, CiPsi, School of Psychology, University of Minho, Campus de Gualtar, Braga, Portugal.'}, {'ForeName': 'Vivian L', 'Initials': 'VL', 'LastName': 'Shie', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Boston-Harvard Burn Injury Model System, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Leite', 'Affiliation': 'Universidade Portucalense, Portucalense Institute for Human Development - INPP, Oporto, Portugal.'}, {'ForeName': 'Corinne Rose', 'Initials': 'CR', 'LastName': 'Ianni', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lewis E', 'Initials': 'LE', 'LastName': 'Kazis', 'Affiliation': 'Department of Health Law, Policy, and Management, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Zafonte', 'Affiliation': 'Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Ryan', 'Affiliation': 'Massachusetts General Hospital, Shriners Hospitals for Children, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Schneider', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/irz084']
1264,31097405,"Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial.","BACKGROUND
As lenalidomide becomes increasingly established for upfront treatment of multiple myeloma, patients refractory to this drug represent a population with an unmet need. The combination of pomalidomide, bortezomib, and dexamethasone has shown promising results in phase 1/2 trials of patients with relapsed or refractory multiple myeloma. We aimed to assess the efficacy and safety of this triplet regimen in patients with relapsed or refractory multiple myeloma who previously received lenalidomide.
METHODS
We did a randomised, open-label, phase 3 trial at 133 hospitals and research centres in 21 countries. We enrolled patients (aged ≥18 years) with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0-2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles. We randomly assigned patients (1:1) to bortezomib and dexamethasone with or without pomalidomide using a permutated blocked design in blocks of four, stratified according to age, number of previous regimens, and concentration of β 2 microglobulin at screening. Bortezomib (1·3 mg/m 2 ) was administered intravenously until protocol amendment 1 then either intravenously or subcutaneously on days 1, 4, 8, and 11 for the first eight cycles and subsequently on days 1 and 8. Dexamethasone (20 mg [10 mg if age >75 years]) was administered orally on the same days as bortezomib and the day after. Patients allocated pomalidomide received 4 mg orally on days 1-14. Treatment cycles were every 21 days. The primary endpoint was progression-free survival in the intention-to-treat population, as assessed by an independent review committee. Safety was assessed in all patients who received at least one dose of study medication. This trial is registered at ClinicalTrials.gov, number NCT01734928; patients are no longer being enrolled.
FINDINGS
Between Jan 7, 2013, and May 15, 2017, 559 patients were enrolled. 281 patients were assigned pomalidomide, bortezomib, and dexamethasone and 278 were allocated bortezomib and dexamethasone. Median follow-up was 15·9 months (IQR 9·9-21·7). Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11·20 months [95% CI 9·66-13·73] vs 7·10 months [5·88-8·48]; hazard ratio 0·61, 95% CI 0·49-0·77; p<0·0001). 278 patients received at least one dose of pomalidomide, bortezomib, and dexamethasone and 270 patients received at least one dose of bortezomib and dexamethasone, and these patients were included in safety assessments. The most common grade 3 or 4 treatment-emergent adverse events were neutropenia (116 [42%] of 278 patients vs 23 [9%] of 270 patients; nine [3%] vs no patients had febrile neutropenia), infections (86 [31%] vs 48 [18%]), and thrombocytopenia (76 [27%] vs 79 [29%]). Serious adverse events were reported in 159 (57%) of 278 patients versus 114 (42%) of 270 patients. Eight deaths were related to treatment; six (2%) were recorded in patients who received pomalidomide, bortezomib, and dexamethasone (pneumonia [n=2], unknown cause [n=2], cardiac arrest [n=1], cardiorespiratory arrest [n=1]) and two (1%) were reported in patients who received bortezomib and dexamethasone (pneumonia [n=1], hepatic encephalopathy [n=1]).
INTERPRETATION
Patients with relapsed or refractory multiple myeloma who previously received lenalidomide had significantly improved progression-free survival when treated with pomalidomide, bortezomib, and dexamethasone compared with bortezomib and dexamethasone. Adverse events accorded with the individual profiles of pomalidomide, bortezomib, and dexamethasone. This study supports use of pomalidomide, bortezomib, and dexamethasone as a treatment option in patients with relapsed or refractory multiple myeloma who previously received lenalidomide.
FUNDING
Celgene.",2019,"Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11·20 months","['pneumonia [n=2], unknown cause [n=2], cardiac arrest [n=1], cardiorespiratory arrest [n=1]) and two (1%) were reported in patients who received', 'patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM', '133 hospitals and research centres in 21 countries', '559 patients were enrolled', '281 patients were assigned', 'patients with relapsed or refractory multiple myeloma', 'Patients with relapsed or refractory multiple myeloma who previously received', '278 patients received at least one dose of', 'Between Jan 7, 2013, and May 15, 2017', 'pneumonia [n=1], hepatic encephalopathy [n=1', 'patients with relapsed or refractory multiple myeloma who previously received lenalidomide', 'enrolled patients (aged ≥18 years) with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0-2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles']","['Bortezomib', 'Pomalidomide, bortezomib, and dexamethasone', 'bortezomib and dexamethasone with or without pomalidomide', 'Dexamethasone', 'pomalidomide, bortezomib', 'bortezomib and dexamethasone', 'pomalidomide, bortezomib, and dexamethasone', 'bortezomib', 'lenalidomide', 'dexamethasone']","['Adverse events', 'thrombocytopenia', 'progression-free survival', 'neutropenia', 'febrile neutropenia), infections', 'Serious adverse events', 'efficacy and safety', 'Safety']","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0600228', 'cui_str': 'Cardiopulmonary Arrest'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",559.0,0.267835,"Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11·20 months","[{'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: paul_richardson@dfci.harvard.edu.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Oriol', 'Affiliation': ""Institut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain.""}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Università degli studi di Perugia, Perugia, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Unità Operativa di Ematologia, Bergamo, Italy.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, Oslo, Norway; K G Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jindriska', 'Initials': 'J', 'LastName': 'Lindsay', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Kent and Canterbury Hospital, Canterbury, UK.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Dalhousie University and Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'University of Lille, Centre Hospitalier Universitaire Lille, Service des Maladies du Sang, Lille, France.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San Miguel', 'Affiliation': 'Clinica Universidad de Navarra, Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Gorman"", 'Affiliation': 'Department of Haematology, Mater Misericordiae University Hospital, Dublin, Ireland; Cancer Trials Ireland, School of Medicine and Medical Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Semochkin', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Schey', 'Affiliation': ""Department of Hematology, King's College London, London, UK.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Doerr', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Bensmaine', 'Affiliation': 'Celgene International, Boudry, Switzerland.'}, {'ForeName': 'Tsvetan', 'Initials': 'T', 'LastName': 'Biyukov', 'Affiliation': 'Celgene International, Boudry, Switzerland.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Peluso', 'Affiliation': 'Celgene International, Boudry, Switzerland.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Zaki', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30152-4']
1265,31140663,Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects.,"AIM
A previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects.
DESIGN
Three-arm, randomized controlled trial.
SETTING
Ten United States academic institutional sites.
PARTICIPANTS
Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity.
INTERVENTIONS
(1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249).
MEASUREMENTS
Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters.
FINDINGS
No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = -0.11; 95% confidence interval (CI) = -0.18, -0.04, P = 0.004] and normal nicotine control groups (mean difference = - 0.15, 95% CI = -0.23, -0.06, P = 0.001).
CONCLUSION
It remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.",2019,"No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = ","['Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD)\xa0=\xa013.4)] years and smoking 17.1 (SD\xa0=\xa08.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity', 'Ten United States academic institutional sites']","['nicotine', 'normal nicotine content cigarettes', 'immediate versus gradual nicotine']","['concentration time curve (AUC', 'red blood cell size variability', 'inflammation, oxidative stress and hematological parameters']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0427488', 'cui_str': 'Red blood cell size - finding'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0303464,"No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = ","[{'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alisa K', 'Initials': 'AK', 'LastName': 'Heskin', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mei Kuen', 'Initials': 'MK', 'LastName': 'Tang', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Carmella', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Moffitt Cancer Center, Department of Health Outcomes and Behavior, Tampa, FL, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry, Philadelphia, University of Pennsylvania, PA, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""al'Absi"", 'Affiliation': 'Behavioral Medicine Laboratories, University of Minnesota Medical School, Duluth, MN, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Leischow', 'Affiliation': 'Mayo Clinic, Health Sciences Research, Scottsdale, AZ, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Ikuemonisan', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14695']
1266,31111862,"Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial.","Importance
Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce.
Objective
To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents.
Design
This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019.
Main Outcomes and Measures
Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods.
Results
In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis.
Conclusions and Relevance
Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts.
Trial Registration
ClinicalTrials.gov identifier: NCT01674803.",2019,"There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02).","['Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels', 'In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available', '1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included', '4 Dutch centers for cardiac intervention', 'patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents']","['Biodegradable Polymer and Durable Polymer Drug-eluting Stents', 'ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents']","['revascularization rate', 'cardiac death, target vessel myocardial infarction, or stent thrombosis', 'target lesion revascularization rate', 'target lesion revascularizations', 'Main Outcomes and Measures\n\n\nTarget lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods', 'Target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0443202', 'cui_str': 'Dissimilar (qualifier value)'}, {'cui': 'C0457591', 'cui_str': 'Type of drug (attribute)'}]","[{'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",1506.0,0.0929333,"There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02).","[{'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Liefke C', 'Initials': 'LC', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Frits H A F', 'Initials': 'FHAF', 'LastName': 'de Man', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1776']
1267,31740083,A Comparative Trial of the Effectiveness of Nasal Interfaces Used to Deliver Continuous Positive Airway Pressure for a Brief Period in Infants With Transient Tachypnea of the Newborn.,"INTRODUCTION
There is insufficient data on the effectiveness of the interfaces used for nasal continuous airway pressure (nCPAP) in newborn infants. Transpulmonary pressure (PTP) calculated from a measured esophageal pressure (Pes) could be used as a surrogate for the pressure transmitted to the distal airways during nCPAP. We aimed to compare the effectiveness of two nasal interfaces, the nasal mask and bi-nasal short prongs, during a relatively brief period of respiratory support by calculated PTP (cPTP) in infants with transient tachypnea of the newborn (TTN).
METHODS
Newborns with TTN who needed respiratory assistance with nCPAP were randomized to use either bi-nasal short prongs or a nasal mask. Esophageal pressure measurements were done in order to calculate PTP with either interface. The primary outcome was the cPTP transmitted with each nasal interface. Esophageal pressure measurements were recorded and PTP values were calculated from Pes measurements at the 1st, 6th, 12th and 24th hours in each patient as long as the respiratory support lasted.
RESULTS
Sixty-two newborns with TTN and on nCPAP were randomized into two groups: Group 1 to use bi-nasal short prongs (n: 31) and Group 2 to use a nasal mask (n: 31). Inspiratory and expiratory Pes and cPTP values at the 1st, 6th, 12th and 24th hours were similar with the two interfaces (P<.05).
CONCLUSIONS
A nasal mask is similarly effective and safe as bi-nasal short prongs during a brief period of non-invasive respiratory support with nCPAP in late preterm and term neonates with TTN.",2020,There is insufficient data on the effectiveness of the interfaces used for nasal continuous airway pressure (nCPAP) in newborn infants.,"['Sixty-two newborns with TTN and on nCPAP', 'newborn infants', 'infants with transient tachypnea of the newborn (TTN', 'Infants With Transient Tachypnea of the Newborn', 'Newborns with TTN who needed respiratory assistance with nCPAP']","['nasal mask and bi-nasal short prongs, during a relatively brief period of respiratory support by calculated PTP (cPTP', 'Nasal Interfaces Used to Deliver Continuous Positive Airway Pressure', 'bi-nasal short prongs or a nasal mask']","['Transpulmonary pressure (PTP', 'PTP values', 'Inspiratory and expiratory Pes and cPTP values', 'cPTP transmitted with each nasal interface', 'nasal continuous airway pressure (nCPAP', 'Esophageal pressure measurements']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0158940', 'cui_str': 'Transient Tachypnea of the Newborn'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C2711254', 'cui_str': 'Dental mask'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0425946', 'cui_str': 'Short menstrual periods (finding)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure (observable entity)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",62.0,0.0309837,There is insufficient data on the effectiveness of the interfaces used for nasal continuous airway pressure (nCPAP) in newborn infants.,"[{'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Cakir', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Children's Hospital, Ankara University School of Medicine, Ankara, Turkey. Electronic address: drufukcakir@hotmail.com.""}, {'ForeName': 'Duran', 'Initials': 'D', 'LastName': 'Yildiz', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Children's Hospital, Ankara University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Okulu', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Children's Hospital, Ankara University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Kahvecioglu', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Children's Hospital, Ankara University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Alan', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Children's Hospital, Ankara University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Erdeve', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Children's Hospital, Ankara University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Begum', 'Initials': 'B', 'LastName': 'Atasay', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Children's Hospital, Ankara University School of Medicine, Ankara, Turkey.""}, {'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Arsan', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Children's Hospital, Ankara University School of Medicine, Ankara, Turkey.""}]",Archivos de bronconeumologia,['10.1016/j.arbres.2019.07.027']
1268,30870268,Effect of acute maximal exercise on vasodilatory function and arterial stiffness in African-American and white adults.,"INTRODUCTION
African-Americans are at increased risk of cardiovascular disease compared with their white counterparts, potentially due to greater arterial stiffness and reduced vasodilatory capacity. Racial differences also exist in arterial stiffness and blood pressure (BP) following maximal aerobic exercise; African-Americans do not exhibit central post exercise BP reductions. Whether impaired vasodilatory function contributes to the lack of BP response is unknown.
PURPOSE
To evaluate vasodilatory function, arterial stiffness, and hemodynamics following a maximal aerobic exercise test in young, healthy African-American and white adults.
METHODS
Twenty-seven African-American and 35 white adults completed measures at baseline, 15 and 30 min after a maximal exercise test. Measures included vasodilatory capacity of forearm resistance arteries, central pulse wave velocity (PWV), and carotid artery stiffness (β).
RESULTS
Forearm reactive hyperemia was greater in white but increased similarly following exercise in both groups (P < 0.05). Carotid β-stiffness increased at 15 and 30 min (P = 0.03) in both groups, but PWV controlled for mean arterial pressure decreased after maximal exercise (P = 0.03). White exhibited reductions in systolic and mean pressure, whereas no changes were seen for African-Americans (interaction effects: P < 0.05).
CONCLUSION
African-American and white adults had similar decreases in PWV, increases in β-stiffness, and increases in vasodilatory function following maximal exercise. African-American adults, however, did not display reductions in BP and had overall lower vasodilatory function in comparison with white adults. Our results suggest African-Americans exhibit similar vasodilatory function changes following aerobic exercise as their white counterparts, and therefore vasodilatory function likely does not explain the lack of BP response in African-Americans.",2019,"RESULTS
Forearm reactive hyperemia was greater in white but increased similarly following exercise in both groups (P < 0.05).","['African-American and 35 white adults', 'African-American adults', 'African-Americans', 'Twenty-seven', 'young, healthy African-American and white adults', 'African-American and white adults']","['aerobic exercise', 'acute maximal exercise', 'maximal aerobic exercise test']","['vasodilatory function and arterial stiffness', 'Carotid β-stiffness', 'PWV', 'vasodilatory function, arterial stiffness, and hemodynamics', 'vasodilatory function', 'vasodilatory capacity of forearm resistance arteries, central pulse wave velocity (PWV), and carotid artery stiffness (β', 'Forearm reactive hyperemia', 'arterial stiffness and blood pressure (BP', 'systolic and mean pressure', 'mean arterial pressure']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0445074', 'cui_str': 'Mean pressure (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",,0.0595516,"RESULTS
Forearm reactive hyperemia was greater in white but increased similarly following exercise in both groups (P < 0.05).","[{'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Schroeder', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Sushant M', 'Initials': 'SM', 'LastName': 'Ranadive', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, Maryland.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Exercise and Health Sciences, University of Massachusetts Boston, Boston, Massachusetts.'}, {'ForeName': 'Abbi D', 'Initials': 'AD', 'LastName': 'Lane-Cordova', 'Affiliation': 'Department of Exercise Science, University of South Carolina at Columbia, Columbia, South Carolina.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Kappus', 'Affiliation': 'Department of Health and Exercise Science, Appalachian State University, Boone.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Cook', 'Affiliation': 'Department of Human Performance and Leisure Studies, North Carolina A&T State University, Greensboro, North Carolina, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fernhall', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, Illinois.'}]",Journal of hypertension,['10.1097/HJH.0000000000002049']
1269,31029692,A transition care coordinator model reduces hospital readmissions and costs.,"BACKGROUND
The optimal structure and intensity of interventions to reduce hospital readmission remains uncertain, due in part to lack of head-to-head comparison. To address this gap, we evaluated two forms of an evidence-based, multi-component transitional care intervention.
METHODS
A quasi-experimental evaluation design compared outcomes of Transition Care Coordinator (TCC) Care to Usual Care, while controlling for sociodemographic characteristics, comorbidities, readmission risk, and administrative factors. The study was conducted between January 1, 2013 and April 30, 2015 as a quality improvement initiative. Eligible adults (N = 7038) hospitalized with pneumonia, congestive heart failure, or chronic obstructive pulmonary disease were identified for program evaluation via an electronic health record algorithm. Nurse TCCs provided either a full intervention (delivered in-hospital and by post-discharge phone call) or a partial intervention (phone call only).
RESULTS
A total of 762 hospitalizations with TCC Care (460 full intervention and 302 partial intervention) and 6276 with Usual Care was examined. In multivariable models, hospitalizations with TCC Care had significantly lower odds of readmission at 30 days (OR = 0.512, 95% CI 0.392 to 0.668) and 90 days (OR = 0.591, 95% CI 0.483 to 0.723). Adjusted costs were significantly lower at 30 days (difference = $3969, 95% CI $5099 to $2691) and 90 days (difference = $5684, 95% CI $7602 to $3627). The effect was similar whether patients received the full or partial intervention.
CONCLUSION
An evidence-based multi-component intervention delivered by nurse TCCs reduced 30- and 90-day readmissions and associated health care costs. Lower intensity interventions delivered by telephone after discharge may have similar effectiveness to in-hospital programs.",2019,Adjusted costs were significantly lower at 30 days (difference ,"['A total of 762 hospitalizations with TCC Care (460 full intervention and 302 partial intervention) and 6276 with Usual Care was examined', 'Eligible adults (N\u202f=\u202f7038) hospitalized with pneumonia, congestive heart failure, or chronic obstructive pulmonary disease were identified for program evaluation via an electronic health record algorithm']","['Transition Care Coordinator (TCC) Care to Usual Care', 'full intervention (delivered in-hospital and by post-discharge phone call) or a partial intervention (phone call only']","['hospital readmissions and costs', 'Adjusted costs', 'odds of readmission']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1098189', 'cui_str': 'tetrakis(2-amino-5-ethyl-1,3,4-thiadiazole-N3)chlorocopper(II) chloride'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0033336', 'cui_str': 'Program Evaluation'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0002045'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",762.0,0.0673055,Adjusted costs were significantly lower at 30 days (difference ,"[{'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Clinical Quality and Implementation Research, Vanderbilt University Medical Center, USA; Center for Health Services Research, Vanderbilt University Medical Center, USA. Electronic address: sunil.kripalani@vanderbilt.edu.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin - Madison, Madison, WI, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ciampa', 'Affiliation': 'Atrius Health, Center for Healthcare Innovation, Newton, MA, USA.'}, {'ForeName': 'Cecelia', 'Initials': 'C', 'LastName': 'Theobald', 'Affiliation': 'Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Clinical Quality and Implementation Research, Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Aize', 'Initials': 'A', 'LastName': 'Cao', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McBride', 'Affiliation': 'Office of Population Health, Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Dittus', 'Affiliation': 'Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Clinical Quality and Implementation Research, Vanderbilt University Medical Center, USA; Center for Health Services Research, Vanderbilt University Medical Center, USA; Department of Veterans Affairs, Valley Healthcare System Geriatric Research Education and Clinical Center (GRECC), TN, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Speroff', 'Affiliation': 'Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Clinical Quality and Implementation Research, Vanderbilt University Medical Center, USA; Center for Health Services Research, Vanderbilt University Medical Center, USA; Department of Biostatistics & Medical Informatics, University of Wisconsin - Madison, Madison, WI, USA; Department of Veterans Affairs, Valley Healthcare System Geriatric Research Education and Clinical Center (GRECC), TN, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.04.014']
1270,30825454,Effective Tyrosinase Inhibition by Thiamidol Results in Significant Improvement of Mild to Moderate Melasma.,"Melasma is a pigmentary disorder characterized by hyperpigmented patchy skin in sun-exposed areas, especially the face. Treatment of melasma can be challenging because long-term therapy is required, reoccurrence is common, and existing therapies are insufficient and unsatisfactory. To investigate new treatment options, we performed an exploratory double-blinded, randomized split-face study to assess the efficacy of the tyrosinase inhibitor Thiamidol compared to hydroquinone in women with mild to moderate melasma. After 12 weeks, modified Melasma Area and Severity Index scores significantly improved on both the Thiamidol-treated and the hydroquinone-treated sides of the face. Additionally, Thiamidol treatment improved modified Melasma Area and Severity Index scores significantly better than hydroquinone, and more subjects improved following treatment with Thiamidol (79%) compared with hydroquinone (61%). During treatment, no subjects displayed worsening of modified Melasma Area and Severity Index scores on the Thiamidol-treated side, while approximately 10% of the subjects showed a worsening of modified Melasma Area and Severity Index scores on the hydroquinone-treated side. All subjects routinely used sunscreens and consistent results were obtained in low and in high UV ambient conditions. Subjects rated the efficacy of the Thiamidol formulation significantly better with regard to overall decreased intensity of dark spots and their overall appearance throughout the study. Thiamidol was well-tolerated and well-perceived and represents an effective agent to reduce hyperpigmentation.",2019,"Additionally, Thiamidol treatment improved modified Melasma Area and Severity Index scores significantly better than hydroquinone, and more subjects improved following treatment with Thiamidol (79%) compared with hydroquinone (61%).",['women with mild to moderate melasma'],"['hydroquinone', 'tyrosinase inhibitor Thiamidol']","['intensity of dark spots', 'modified Melasma Area and Severity Index scores', 'worsening of modified Melasma Area and Severity Index scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0020307', 'cui_str': 'Quinols'}, {'cui': 'C0041484', 'cui_str': 'Phenol Oxidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",,0.0190578,"Additionally, Thiamidol treatment improved modified Melasma Area and Severity Index scores significantly better than hydroquinone, and more subjects improved following treatment with Thiamidol (79%) compared with hydroquinone (61%).","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Arrowitz', 'Affiliation': 'Beiersdorf Inc, Wilton, Connecticut, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Schoelermann', 'Affiliation': 'Beiersdorf AG, Hamburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Mann', 'Affiliation': 'Beiersdorf AG, Hamburg, Germany.'}, {'ForeName': 'Lily I', 'Initials': 'LI', 'LastName': 'Jiang', 'Affiliation': 'Thomas J. Stephens & Associates, Inc, Richardson, Texas, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Beiersdorf Inc, Wilton, Connecticut, USA.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Kolbe', 'Affiliation': 'Beiersdorf AG, Hamburg, Germany. Electronic address: Ludger.Kolbe@Beiersdorf.com.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.02.013']
1271,31082847,Tendon Subluxation After Surgical Release of the First Dorsal Compartment in De Quervain Disease.,"We aimed to determine whether dorsoulnar incision elevating radial flap and immobilization for the treatment of de Quervain disease have an advantage over simple midline incision and early mobilization, respectively, in terms of tendon subluxation and clinical outcomes. Forty-six patients with de Quervain disease were randomly divided into 2 groups (midline incision vs dorsoulnar incision) and 2 subgroups (immobilization vs early mobilization). Subluxation of intracompartmental tendons was measured in dynamic wrist positions at 12 and 24 weeks using ultrasonography. The DASH (Disabilities of the Arm, Shoulder, and Hand) and visual analog scale scores and grip and pinch strengths were evaluated. At 24 weeks, the tendons were displaced voloradially in wrist volar flexion (1.25 mm in midline incision vs 0.36 mm in dorsoulnar incision, P = 0.001), whereas the tendons were displaced dorsoulnarly in wrist extension (0.95 mm in midline incision vs 1.78 mm in dorsoulnar incision, P = 0.041). There were no significant differences in tendon displacement between early mobilization and immobilization groups. Clinical outcome measures showed no variation between the groups, and no significant correlation occurred with tendon subluxation. Dorsoulnar incision and postoperative immobilization do not have advantage over midline incision and early mobilization, respectively. However, tendon subluxation after release of the first dorsal compartment for de Quervain disease does not affect clinical outcomes.",2019,Subluxation of intracompartmental tendons was measured in dynamic wrist positions at 12 and 24 weeks using ultrasonography.,['Forty-six patients with de Quervain disease'],"['midline incision vs dorsoulnar incision) and 2 subgroups (immobilization vs early mobilization', 'dorsoulnar incision elevating radial flap and immobilization', 'Tendon Subluxation']","['tendon displacement', 'wrist volar flexion', 'wrist extension', 'tendon subluxation', 'DASH (Disabilities of the Arm, Shoulder, and Hand) and visual analog scale scores and grip and pinch strengths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149870', 'cui_str': 'Stenosing Tenosynovitis, De Quervain'}]","[{'cui': 'C0456276', 'cui_str': 'Midline incision (procedure)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C2036883', 'cui_str': 'Tendon subluxation'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C2036883', 'cui_str': 'Tendon subluxation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}]",46.0,0.0306002,Subluxation of intracompartmental tendons was measured in dynamic wrist positions at 12 and 24 weeks using ultrasonography.,"[{'ForeName': 'Ji-Hyo', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Career Education, College of General Education.'}, {'ForeName': 'Seog-Won', 'Initials': 'SW', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine, and.'}, {'ForeName': 'Hee-Jeong', 'Initials': 'HJ', 'LastName': 'Ham', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine, and.'}, {'ForeName': 'Jong-Pil', 'Initials': 'JP', 'LastName': 'Kim', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0000000000001860']
1272,31732133,Physiotherapy for Children with Functional Constipation: A Pragmatic Randomized Controlled Trial in Primary Care.,"OBJECTIVE
To determine the effectiveness of physiotherapy plus conventional treatment compared with conventional treatment alone for the treatment of functional constipation in children age 4-17 years in primary care.
STUDY DESIGN
Pragmatic randomized controlled trial with 8 months follow-up. Primary care physicians recruited children diagnosed with functional constipation (n = 234), and pediatricians recruited newly referred children with a diagnosis of functional constipation (n = 11). Conventional treatment comprised toilet training, nutritional advice, and laxative prescribing, whereas physiotherapy focused on resolving dyssynergic defecation. The primary outcome was treatment success over 8 months, defined as the absence of functional constipation (Rome III criteria) without laxative use. Secondary outcomes included the absence of functional constipation irrespective of continuation of laxative use and global perceived treatment effect.
RESULTS
Children were allocated to conventional treatment plus physiotherapy or conventional treatment alone (67 per group), mean (SD) age was 7.6 (3.5) years. Results of longitudinal analyses in the intention-to-treat population showed that the treatment success percentage was not statistically improved by adding physiotherapy to conventional treatment (adjusted relative risk [aRR] 0.80, 95% CI 0.44-1.30). At 4 months, fewer children receiving physiotherapy had treatment success (17%) than children receiving conventional treatment alone (28%), but this had equalized by 8 months (42% and 41%, respectively). The percentage of children without functional constipation, irrespective of continuation of laxative use, was not statistically different between groups over 8 months (aRR 1.12, 95% CI 0.82-1.34). Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73).
CONCLUSIONS
We find no evidence to recommend physiotherapy for all children with functional constipation in primary care.
TRIAL REGISTRATION
Netherlands Trial Registry: NTR4797.",2020,"Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73).
","['Primary care physicians recruited children diagnosed with functional constipation (n\xa0=\xa0234), and pediatricians recruited newly referred children with a diagnosis of functional constipation (n\xa0=\xa011', 'Children', 'children with functional constipation in primary care', 'Children with Functional Constipation', 'children age 4-17\xa0years in primary care']","['conventional treatment plus physiotherapy or conventional treatment alone', 'physiotherapy plus conventional treatment', 'Physiotherapy', 'toilet training, nutritional advice, and laxative prescribing']","['functional constipation', 'treatment success over 8\xa0months, defined as the absence of functional constipation (Rome III criteria) without laxative use', 'treatment success', 'global symptom improvement', 'percentage of children without functional constipation', 'absence of functional constipation irrespective of continuation of laxative use and global perceived treatment effect']","[{'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0040365', 'cui_str': 'Toilet Training'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}]","[{'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.127033,"Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73).
","[{'ForeName': 'Jojanneke J G T', 'Initials': 'JJGT', 'LastName': 'van Summeren', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands. Electronic address: j.j.g.t.van.summeren@umcg.nl.'}, {'ForeName': 'Gea A', 'Initials': 'GA', 'LastName': 'Holtman', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Boudewijn J', 'Initials': 'BJ', 'LastName': 'Kollen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Lisman-van Leeuwen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Alice H C', 'Initials': 'AHC', 'LastName': 'van Ulsen-Rust', 'Affiliation': 'Pediatric Pelvic Physiotherapy, Pelvicum kinderbekkenfysiotherapie, Groningen, the Netherlands.'}, {'ForeName': 'Merit M', 'Initials': 'MM', 'LastName': 'Tabbers', 'Affiliation': ""Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital/Amsterdam UMC-Location AMC, Amsterdam, the Netherlands.""}, {'ForeName': 'Janny H', 'Initials': 'JH', 'LastName': 'Dekker', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Marjolein Y', 'Initials': 'MY', 'LastName': 'Berger', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.09.048']
1273,31655449,Changes (but not differences) in motion direction fail to capture attention.,"In this study we investigated under what conditions motion direction changes pop out in continuously moving target/distractor environments. Participants were presented with vertically oriented Gabor patches whose carrier components drifted at a constant speed from left to right and then reversed direction. On any given trial, one of these elements was nominated as the target and the remaining elements were distractors. Distractor elements all changed direction simultaneously. The distractors either moved in a homogeneous manner (i.e. all moved in the same direction), or in a heterogeneous manner (i.e. direction was randomized). The target moved with a similar spatio-temporal trajectory as the distractors from left to right (or vice versa), but changed direction asynchronously with respect to the distracting elements. The participants' task was to locate this deviant (target) Gabor patch. We show that a motion direction change pops out (as indicated by the absence of a set size effect) when the surrounding distractors move in a homogeneous direction. When the distractors moved in heterogenous directions, a similar pop out effect was observed when the set size was small (≤5 elements), but not when it was large. This suggests that motion direction changes capture attention only when the change results in a unique direction of motion. Consistent with this finding we also show that a moving target (without direction change) captures attention in cases in which all distractors recently changed direction. This corroborates the idea that, in addition to direction cues, the temporal uniqueness of a change in an object's direction (or absence, thereof) relative to surrounding objects is a cue capable of capturing attention.",2019,"The target moved with a similar spatio-temporal trajectory as the distractors from left to right (or vice versa), but changed direction asynchronously with respect to the distracting elements.",[],[],[],[],[],[],,0.0265601,"The target moved with a similar spatio-temporal trajectory as the distractors from left to right (or vice versa), but changed direction asynchronously with respect to the distracting elements.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Van der Burg', 'Affiliation': 'Department of Experimental and Applied Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; School of Psychology, University of Sydney, Australia; Institute for Brain and Behaviour, Amsterdam, Netherlands. Electronic address: vanderburg.erik@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cass', 'Affiliation': 'School of Social Sciences & Psychology, Western Sydney University, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Theeuwes', 'Affiliation': 'Department of Experimental and Applied Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Institute for Brain and Behaviour, Amsterdam, Netherlands.'}]",Vision research,['10.1016/j.visres.2019.09.008']
1274,30797651,Exercise for Depression: A Feasibility Trial Exploring Neural Mechanisms.,"OBJECTIVE
The aim of this study was to test the feasibility of an exercise augmentation to pharmacotherapy in depressed younger and older adults while exploring neural mechanisms.
METHODS
A randomized, double-blind, controlled clinical trial was conducted in 15 inactive younger (20-39 years) and older (60-79 years) adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for a major depressive episode (https://clinicaltrials.gov/ct2/show/NCT02407704). Participants were randomized to receive a 12-week regimen of venlafaxine XR or venlafaxine XR plus supervised exercise. Cardiorespiratory fitness was assessed using a submaximal Vo 2 test, and neuroimaging assessments were conducted using a Siemans MAGNETOM 7-Tesla magnetic resonance scanner at the University of Pittsburgh.
RESULTS
Attrition was 38% and 14% for the medication and exercise groups, respectively. Attendance was 91% for the exercise intervention. Exploratory analyses revealed an association between improvement in fitness and increased cortical thickness in the anterior cingulate cortex.
CONCLUSION
Exercise augmentation to pharmacotherapy is feasible for depressed younger and older adults and may have neural benefits in a core brain region implicated in depression.",2019,"Exploratory analyses revealed an association between improvement in fitness and increased cortical thickness in the anterior cingulate cortex.
","['depressed younger and older adults', '15 inactive younger (20-39 years) and older (60-79 years) adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for a major depressive episode (https://clinicaltrials.gov/ct2/show/NCT02407704']","['venlafaxine XR or venlafaxine XR plus supervised exercise', 'exercise augmentation to pharmacotherapy']","['Cardiorespiratory fitness', 'Attendance', 'cortical thickness']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.149387,"Exploratory analyses revealed an association between improvement in fitness and increased cortical thickness in the anterior cingulate cortex.
","[{'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Gujral', 'Affiliation': 'VA VISN 4 Mental Illness Research, Education and Clinical Center of Excellence (SG), Pittsburgh; Department of Psychology (SG, GG, KIE), University of Pittsburgh, Pittsburgh; Department of Psychiatry (SG, HA, CFR, MAB, JFK), Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh. Electronic address: shemacha@gmail.com.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Aizenstein', 'Affiliation': 'Department of Psychiatry (SG, HA, CFR, MAB, JFK), Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry (SG, HA, CFR, MAB, JFK), Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'Department of Psychiatry (SG, HA, CFR, MAB, JFK), Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Grove', 'Affiliation': 'Department of Psychology (SG, GG, KIE), University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry (SG, HA, CFR, MAB, JFK), Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh.'}, {'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychology (SG, GG, KIE), University of Pittsburgh, Pittsburgh.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.01.012']
1275,31078475,Financial Incentives to Increase Cardiac Rehabilitation Participation Among Low-Socioeconomic Status Patients: A Randomized Clinical Trial.,"OBJECTIVES
This study sought to examine the efficacy of financial incentives to increase Medicaid patient participation in and completion of cardiac rehabilitation (CR).
BACKGROUND
Participation in CR reduces morbidity, mortality, and hospitalizations while improving quality of life. Lower-socioeconomic status (SES) patients are much less likely to attend and complete CR, despite being at increased risk for recurrent cardiovascular events.
METHODS
A total of 130 individuals enrolled in Medicaid with a CR-qualifying cardiac event were randomized 1:1 to receive financial incentives on an escalating schedule ($4 to $50) for completing CR sessions or to receive usual care. Primary outcomes were CR participation (number of sessions completed) and completion (≥30 sessions completed). Secondary outcomes included changes in sociocognitive measurements (depressive/anxious symptoms, executive function), body composition (waist circumference, body mass index), fitness (peak VO 2 ) over 4 months, and combined number of hospitalizations and emergency department (ED) contacts over 1 year.
RESULTS
Patients randomized to the incentive condition completed more sessions (22.4 vs. 14.7, respectively; p = 0.013) and were almost twice as likely to complete CR (55.4% vs. 29.2%, respectively; p = 0.002) as controls. Incentivized patients were also more likely to experience improvements in executive function (p < 0.001), although there were no significant effects on other secondary outcomes. Patients who completed ≥30 sessions had 47% fewer combined hospitalizations and ED visits (p = 0.014), as reflected by a nonsignificant trend by study condition with 39% fewer hospital contacts in the incentive condition group (p = 0.079).
CONCLUSIONS
Financial incentives improve CR participation among lower-SES patients following a cardiac event. Increasing participation among lower-SES patients in CR is critical for positive longer-term health outcomes. (Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees; NCT02172820).",2019,"Patients who completed ≥30 sessions had 47% fewer combined hospitalizations and ED visits (p = 0.014), as reflected by a nonsignificant trend by study condition with 39% fewer hospital contacts in the incentive condition group (p = 0.079).
","['A total of 130 individuals enrolled in Medicaid with a CR-qualifying cardiac event', 'Low-Socioeconomic Status Patients']",['financial incentives on an escalating schedule ($4 to $50) for completing CR sessions or to receive usual care'],"['hospital contacts', 'CR participation', 'morbidity, mortality, and hospitalizations while improving quality of life', 'CR participation (number of sessions completed) and completion', 'executive function', 'combined hospitalizations and ED visits', 'changes in sociocognitive measurements (depressive/anxious symptoms, executive function), body composition (waist circumference, body mass index), fitness (peak VO 2 ) over 4 months, and combined number of hospitalizations and emergency department (ED) contacts over 1 year']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",130.0,0.103883,"Patients who completed ≥30 sessions had 47% fewer combined hospitalizations and ED visits (p = 0.014), as reflected by a nonsignificant trend by study condition with 39% fewer hospital contacts in the incentive condition group (p = 0.079).
","[{'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont; Department of Psychology, University of Vermont, Burlington, Vermont. Electronic address: dgaalema@uvm.edu.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Elliott', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Savage', 'Affiliation': 'Division of Cardiology, University of Vermont Medical Center, Burlington, Vermont.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Rengo', 'Affiliation': 'Division of Cardiology, University of Vermont Medical Center, Burlington, Vermont.'}, {'ForeName': 'Alex Y', 'Initials': 'AY', 'LastName': 'Cutler', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pericot-Valverde', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Priest', 'Affiliation': 'Department of Medical Biostatistics, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Shepard', 'Affiliation': 'Heller School for Social Policy and Management, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont; Department of Psychology, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Ades', 'Affiliation': 'Division of Cardiology, University of Vermont Medical Center, Burlington, Vermont.'}]",JACC. Heart failure,['10.1016/j.jchf.2018.12.008']
1276,31805614,"Brief mindfulness, mental health, and cognitive processes: A randomized controlled trial.","The present study evaluated the impact of a brief mindfulness training program on emotional regulation, cognitive rumination, psychological well-being, and depressive symptoms. This is an experimental study, through a randomized controlled trial. A total of 103 people enrolled on a voluntary basis, of whom 51 were randomly selected to participate in the experimental group and 52 in the control group without intervention (on the waiting list). It is established that a brief, four-session mindfulness training program significantly increases psychological well-being and significantly reduces the symptoms associated with depression; there was a decrease in emotional suppression and in intrusive and deliberate rumination, and an increase in cognitive reappraisal. Implications of this brief mindfulness program on the symptoms associated with depression, psychological well-being, emotional regulation, and cognitive rumination are analyzed, as are the scope and limitations of the study.",2020,"A total of 103 people enrolled on a voluntary basis, of whom 51 were randomly selected to participate in the experimental group and 52 in the control group without intervention (on the waiting list).","['103 people enrolled on a voluntary basis, of whom 51 were randomly selected to participate in the experimental group and 52 in the']","['mindfulness training program', 'control group without intervention']","['cognitive reappraisal', 'Brief mindfulness, mental health, and cognitive processes', 'emotional suppression and in intrusive and deliberate rumination', 'depression, psychological well-being, emotional regulation, and cognitive rumination', 'emotional regulation, cognitive rumination, psychological well-being, and depressive symptoms']","[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C4505206', 'cui_str': 'Rumination, Cognitive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",103.0,0.0219192,"A total of 103 people enrolled on a voluntary basis, of whom 51 were randomly selected to participate in the experimental group and 52 in the control group without intervention (on the waiting list).","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Cerna', 'Affiliation': 'Universidad de Las Américas [University of the Americas], Concepción, Chile.'}, {'ForeName': 'Felipe E', 'Initials': 'FE', 'LastName': 'García', 'Affiliation': 'Facultad de Ciencias Sociales y Comunicaciones, Universidad Santo Tomás [Saint Thomas University], Chile.'}, {'ForeName': 'Arnoldo', 'Initials': 'A', 'LastName': 'Téllez', 'Affiliation': 'Department of Psychology, Universidad Autónoma de Nuevo León [Autonomous University of Nuevo León], Monterrey, Mexico.'}]",PsyCh journal,['10.1002/pchj.325']
1277,31078459,"Two-view digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening programme (To-Be): a randomised, controlled trial.","BACKGROUND
Digital breast tomosynthesis is an advancement of mammography, and has the potential to overcome limitations of standard digital mammography. This study aimed to compare first-generation digital breast tomo-synthesis including two-dimensional (2D) synthetic mammograms versus digital mammography in a population-based screening programme.
METHODS
BreastScreen Norway offers all women aged 50-69 years two-view (craniocaudal and mediolateral oblique) mammographic screening every 2 years and does independent double reading with consensus. We asked all 32 976 women who attended the programme in Bergen in 2016-17, to participate in this randomised, controlled trial with a parallel group design. A study-specific software was developed to allocate women to either digital breast tomosynthesis or digital mammography using a 1:1 simple randomisation method based on participants' unique national identity numbers. The interviewing radiographer did the randomisation by entering the number into the software. Randomisation was done after consent and was therefore concealed from both the women and the radiographer at the time of consent; the algorithm was not disclosed to radiographers during the recruitment period. All data needed for analyses were complete 12 months after the recruitment period ended. The primary outcome measure was screen-detected breast cancer, stratified by screening technique (ie, digital breast tomosynthesis and digital mammography). A log-binomial regression model was used to estimate the efficacy of digital breast tomosynthesis versus digital mammography, defined as the crude risk ratios (RRs) with 95% CIs for screen-detected breast cancer for women screened during the recruitment period. A per-protocol approach was used in the analyses. This trial is registered at ClinicalTrials.gov, number NCT02835625, and is closed to accrual.
FINDINGS
Between, Jan 14, 2016, and Dec 31, 2017, 44 266 women were invited to the screening programme in Bergen, and 32 976 (74·5%) attended. After excluding women with breast implants and women who did not consent to participate, 29 453 (89·3%) were eligible for electronic randomisation. 14 734 women were allocated to digital breast tomosynthesis and 14 719 to digital mammography. After randomisation, women with a previous breast cancer were excluded (digital breast tomosynthesis group n=314, digital mammography group n=316), women with metastases from melanoma (digital breast tomosynthesis group n=1), and women who informed the radiographer about breast symptoms after providing consent (digital breast tomosynthesis group n=39, digital mammography group n=34). After exclusions, information from 28 749 women were included in the analyses (digital breast tomosynthesis group n=14 380, digital mammography group n=14 369). The proportion of screen-detected breast cancer among the screened women did not differ between the two groups (95 [0·66%, 0·53-0·79] of 14 380 vs 87 [0·61%, 0·48-0·73] of 14 369; RR 1·09, 95% CI 0·82-1·46; p=0·56).
INTERPRETATION
This study indicated that digital breast tomosynthesis including synthetic 2D mammograms was not significantly different from standard digital mammography as a screening tool for the detection of breast cancer in a population-based screening programme. Economic analyses and follow-up studies on interval and consecutive round screen-detected breast cancers are needed to better understand the effect of digital breast tomosynthesis in population-based breast cancer screening.
FUNDING
Cancer Registry of Norway, Department of Radiology at Haukeland University Hospital, University of Oslo, and Research Council of Norway.",2019,This study indicated that digital breast tomosynthesis including synthetic 2D mammograms was not significantly different from standard digital mammography as a screening tool for the detection of breast cancer in a population-based screening programme.,"['Between, Jan 14, 2016, and Dec 31, 2017, 44\u2008266 women were invited to the screening programme in Bergen, and 32\u2008976 (74·5%) attended', '14\u2008734 women', 'After exclusions, information from 28\u2008749 women were included in the analyses (digital breast tomosynthesis group n=14\u2008380, digital mammography group n=14\u2008369', 'women with breast implants and women who did not consent to participate, 29\u2008453 (89·3%) were eligible for electronic randomisation', 'women with a previous breast cancer were excluded (digital breast tomosynthesis group n=314, digital mammography group n=316), women with metastases from melanoma (digital breast tomosynthesis group n=1), and women who informed the radiographer about breast symptoms after providing consent (digital breast tomosynthesis group n=39, digital mammography group n=34', '32\u2008976 women who attended the programme in Bergen in 2016-17', 'BreastScreen Norway offers all women aged 50-69 years two-view (craniocaudal and mediolateral oblique) mammographic screening every 2 years and does independent double reading with consensus']","['digital breast tomosynthesis or digital mammography', 'digital breast tomosynthesis and 14\u2008719 to digital mammography', 'Two-view digital breast tomosynthesis versus digital mammography', 'generation digital breast tomo-synthesis including two-dimensional (2D) synthetic mammograms versus digital mammography', 'standard digital mammography']","['proportion of screen-detected breast cancer', 'screen-detected breast cancer, stratified by screening technique (ie, digital breast tomosynthesis and digital mammography']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C0179412', 'cui_str': 'Breast Prosthesis, Internal'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0402007', 'cui_str': 'Medical radiographer (occupation)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}]","[{'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}]",44266.0,0.0863837,This study indicated that digital breast tomosynthesis including synthetic 2D mammograms was not significantly different from standard digital mammography as a screening tool for the detection of breast cancer in a population-based screening programme.,"[{'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Hofvind', 'Affiliation': 'Department of Breast Screening, Cancer Registry of Norway, Oslo, Norway; Faculty of of Health Sciences, Oslo Metropolitan University, Oslo, Norway. Electronic address: solveig.hofvind@kreftregisteret.no.'}, {'ForeName': 'Åsne S', 'Initials': 'ÅS', 'LastName': 'Holen', 'Affiliation': 'Department of Breast Screening, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Hildegunn S', 'Initials': 'HS', 'LastName': 'Aase', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway; Deparment of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Nehmat', 'Initials': 'N', 'LastName': 'Houssami', 'Affiliation': 'Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Sebuødegård', 'Affiliation': 'Department of Breast Screening, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Tron A', 'Initials': 'TA', 'LastName': 'Moger', 'Affiliation': 'Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ingfrid S', 'Initials': 'IS', 'LastName': 'Haldorsen', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway; Deparment of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Lars A', 'Initials': 'LA', 'LastName': 'Akslen', 'Affiliation': 'Department of Pathology, Haukeland University Hospital, Bergen, Norway; Centre for Cancer Biomarkers, Haukeland University Hospital, Bergen, Norway; Deparment of Clinical Medicine, University of Bergen, Bergen, Norway.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30161-5']
1278,31076365,"Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial.","BACKGROUND
Angiopoietin 1 and 2 regulate angiogenesis and vascular remodelling by interacting with the tyrosine kinase receptor Tie2, and inhibition of angiogenesis has shown promise in the treatment of ovarian cancer. We aimed to assess whether trebananib, a peptibody that inhibits binding of angiopoietin 1 and 2 to Tie2, improved progression-free survival when added to carboplatin and paclitaxel as first-line therapy in advanced epithelial ovarian, primary fallopian tube, or peritoneal cancer in a phase 3 clinical trial.
METHODS
TRINOVA-3, a multicentre, multinational, phase 3, double-blind study, was done at 206 investigational sites (hospitals and cancer centres) in 14 countries. Eligible patients were aged 18 years or older with biopsy-confirmed International Federation of Gynecology and Obstetrics (FIGO) stage III to IV epithelial ovarian, primary peritoneal, or fallopian tube cancers, and an ECOG performance status of 0 or 1. Eligible patients were randomly assigned (2:1) using a permuted block method (block size of six patients) to receive six cycles of paclitaxel (175 mg/m 2 ) and carboplatin (area under the serum concentration-time curve 5 or 6) every 3 weeks, plus weekly intravenous trebananib 15 mg/kg or placebo. Maintenance therapy with trebananib or placebo continued for up to 18 additional months. The primary endpoint was progression-free survival, as assessed by the investigators, in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01493505, and is complete.
FINDINGS
Between Jan 30, 2012, and Feb 25, 2014, 1164 patients were screened and 1015 eligible patients were randomly allocated to treatment (678 to trebananib and 337 to placebo). After a median follow-up of 27·4 months (IQR 17·7-34·2), 626 patients had progression-free survival events (405 [60%] of 678 in the trebananib group and 221 [66%] of 337 in the placebo group). Median progression-free survival did not differ between the trebananib group (15·9 months [15·0-17·6]) and the placebo group (15·0 months [12·6-16·1]) groups (hazard ratio 0·93 [95% CI 0·79-1·09]; p=0·36). 512 (76%) of 675 patients in the trebananib group and 237 (71%) of 336 in the placebo group had grade 3 or worse treatment-emergent adverse events; of which the most common events were neutropenia (trebananib 238 [35%] vs placebo 126 [38%]) anaemia (76 [11%] vs 40 [12%]), and leucopenia (81 [12%] vs 35 [10%]). 269 (40%) patients in the trebananib group and 104 (31%) in the placebo group had serious adverse events. Two fatal adverse events in the trebananib group were considered related to trebananib, paclitaxel, and carboplatin (lung infection and neutropenic colitis); two were considered to be related to paclitaxel and carboplatin (general physical health deterioration and platelet count decreased). No treatment-related fatal adverse events occurred in the placebo group.
INTERPRETATION
Trebananib plus carboplatin and paclitaxel did not improve progression-free survival as first-line treatment for advanced ovarian cancer. The combination of trebananib plus carboplatin and paclitaxel did not produce new safety signals. These results show that trebananib in combination with carboplatin and paclitaxel is minimally effective in this patient population.
FUNDING
Amgen.",2019,"No treatment-related fatal adverse events occurred in the placebo group.
","['advanced ovarian cancer', 'advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001', 'Between Jan 30, 2012, and Feb 25, 2014, 1164 patients were screened and 1015 eligible patients', '206 investigational sites (hospitals and cancer centres) in 14 countries', 'patients who received at least one dose of study treatment', 'advanced epithelial ovarian, primary fallopian tube, or peritoneal cancer in a phase 3 clinical trial', 'Eligible patients', 'Eligible patients were aged 18 years or older with biopsy-confirmed International Federation of Gynecology and Obstetrics (FIGO) stage III to IV epithelial ovarian, primary peritoneal, or fallopian tube cancers, and an ECOG performance status of 0 or 1']","['carboplatin', 'placebo', 'Trebananib plus carboplatin and paclitaxel', 'trebananib 15 mg/kg or placebo', 'trebananib plus carboplatin and paclitaxel', 'carboplatin and paclitaxel', 'Trebananib or placebo plus carboplatin and paclitaxel', 'trebananib or placebo', 'paclitaxel and carboplatin', 'permuted block method (block size of six patients) to receive six cycles of paclitaxel']","['anaemia', 'grade 3 or worse treatment-emergent adverse events', 'progression-free survival', 'progression-free survival events', 'neutropenia', 'trebananib, paclitaxel, and carboplatin (lung infection and neutropenic colitis', 'leucopenia', 'serious adverse events', 'Median progression-free survival', 'fatal adverse events']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0238122', 'cui_str': 'Fallopian Tube Cancer'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660912', 'cui_str': 'trenananib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C3660912', 'cui_str': 'trenananib'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0400823', 'cui_str': 'Neutropenic colitis (disorder)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",1164.0,0.629914,"No treatment-related fatal adverse events occurred in the placebo group.
","[{'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven, Belgium; European Network of Gynaecological Oncological Trial groups (ENGOT), Divison of Gynecologic Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium. Electronic address: ignace.vergote@uzleuven.be.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Multicenter Italian Trials in Ovarian Cancer Society (MITO), Rome, Italy; Fondazione Policlinico Universitario A Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Università Cattolica, Rome, Italy.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Gynecologic Oncology Group, James Comprehensive Cancer Center, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Van Calster', 'Affiliation': 'Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven, Belgium; Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Sang-Yoon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Del Campo', 'Affiliation': ""Grupo Español de Investigación en Cáncer de Ovario (GEICO), Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': 'Arbeitsgemeinschaft Gynaekologische Onkologie Study Group (AGO), Department of Gynecology and Obstetrics, AGO-Germany and Evangelic Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'Department of Clinical Therapeutics, Alexandra Hospital, National & Kapodistrian University of Athens, Athens, Greece; Hellenic Cooperative Oncology Group (HECOG), Athens, Greece.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Mario Negri Gynecologic Oncology Group (MANGO), European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy; Università Milano Bicocca, Milan, Italy.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'Gynecologic Oncology Group, Department of Gynecologic Oncology, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Covens', 'Affiliation': 'Division of Gynecologic Oncology, Toronto Sunnybrook Regional Cancer Center, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marth', 'Affiliation': 'Arbeitsgemeinschaft Gynaekologische Onkologie Study Group (AGO)-Austria, Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Raza Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology (NSGO), Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Dutch Gynecological Oncology Group (DCOG), Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Global Development Oncology, Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Pickett', 'Affiliation': 'Global Development Oncology, Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Gynecologic Oncology Group, Arizona Oncology (US Oncology Network), University of Arizona, Phoenix, AZ, USA; Creighton University, Phoenix, AZ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30178-0']
1279,31060079,Extended Postoperative Prophylactic Antibiotics with First-Generation Cephalosporin Do Not Reduce the Risk of Periprosthetic Joint Infection following Aseptic Revision Total Knee Arthroplasty.,"Postoperative prophylactic antibiotics administered within 24 hours of primary total knee arthroplasty (TKA) have been documented to prevent periprosthetic joint infection (PJI). However, the effectiveness of this regimen is still unclear in aseptic revision TKA. The purpose of this study was to evaluate whether extended postoperative prophylactic antibiotics would reduce the PJI rate compared with the current 24-hour standard postoperative prophylactic antibiotics after aseptic revision TKA. A retrospective review of 236 patients (46 men, 190 women, 252 knees) who underwent aseptic revision TKA between 2005 and 2013 was conducted. Patients who underwent septic revision, had a positive intraoperative culture, or who had less than 2 years of follow-up were excluded. Patients were divided according to the duration of postoperative prophylactic antibiotics to standard group (76 knees, ≤ 24 hours) or extended group (176 knees, > 24 hours). PJI was determined by the Musculoskeletal Infection Society criteria. A multivariate Cox proportional hazards regression analysis was performed. The mean follow-up was 5.2 ± 2.5 years. Patients with extended postoperative prophylactic antibiotics had a lower PJI rate (1.1%) compared with standard group (3.9%), but the difference was not statistically significant ( p = 0.14). Body mass index ≥ 30 kg/m 2 was the only independent risk factor of PJI (adjusted hazard ratio [HR]: 9.59; 95% confidence interval [CI]: 1.07-86.04, p = 0.043). The use of extended postoperative prophylactic antibiotics was not a risk factor for PJI (adjusted HR: 0.34; 95% CI: 0.06-2.04, p = 0.238). After 10 years, the two groups had similar infection-free implant survival rate (95.9 vs. 98.9%, p = 0.15). Our findings demonstrate that extended postoperative prophylactic antibiotics did not reduce PJI rate compared with the standard group in aseptic revision TKA. A further prospective, randomized study with a standardized postoperative antibiotic protocol is necessary to address this topic. Level of evidence is prognostic Level III.",2020,Our findings demonstrate that extended postoperative prophylactic antibiotics did not reduce PJI rate compared with the standard group in aseptic revision TKA.,"['primary total knee arthroplasty (TKA', 'Patients who underwent septic revision, had a positive intraoperative culture, or who had less than 2 years of follow-up were excluded', 'Aseptic Revision Total Knee Arthroplasty', '236 patients (46 men, 190 women, 252 knees) who underwent aseptic revision TKA between 2005 and 2013 was conducted']",['Postoperative prophylactic antibiotics'],"['Periprosthetic Joint Infection', 'PJI rate', 'similar infection-free implant survival rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.152124,Our findings demonstrate that extended postoperative prophylactic antibiotics did not reduce PJI rate compared with the standard group in aseptic revision TKA.,"[{'ForeName': 'Feng-Chih', 'Initials': 'FC', 'LastName': 'Kuo', 'Affiliation': 'Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan.'}, {'ForeName': 'Po-Chun', 'Initials': 'PC', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Bell', 'Affiliation': 'The Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jih-Yang', 'Initials': 'JY', 'LastName': 'Ko', 'Affiliation': 'Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ching-Jen', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan.'}, {'ForeName': 'Jun-Wen', 'Initials': 'JW', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung, Taiwan.'}]",The journal of knee surgery,['10.1055/s-0039-1683889']
1280,31063868,"Rationale, design, and baseline characteristics of WalkIT Arizona: A factorial randomized trial testing adaptive goals and financial reinforcement to increase walking across higher and lower walkable neighborhoods.","Little change over the decades has been seen in adults meeting moderate-to-vigorous physical activity (MVPA) guidelines. Numerous individual-level interventions to increase MVPA have been designed, mostly static interventions without consideration for neighborhood context. Recent technologies make adaptive interventions for MVPA feasible. Unlike static interventions, adaptive intervention components (e.g., goal setting) adjust frequently to an individual's performance. Such technologies also allow for more precise delivery of ""smaller, sooner incentives"" that may result in greater MVPA than ""larger, later incentives"". Combined, these factors could enhance MVPA adoption. Additionally, a central tenet of ecological models is that MVPA is sensitive to neighborhood environment design; lower-walkable neighborhoods constrain MVPA adoption and maintenance, limiting the effects of individual-level interventions. Higher-walkable neighborhoods are hypothesized to enhance MVPA interventions. Few prospective studies have addressed this premise. This report describes the rationale, design, intervention components, and baseline sample of a study testing individual-level adaptive goal-setting and incentive interventions for MVPA adoption and maintenance over 2 years among adults from neighborhoods known to vary in neighborhood walkability. We scaled these evidenced-based interventions and tested them against static-goal-setting and delayed-incentive comparisons in a 2 × 2 factorial randomized trial to increase MVPA among 512 healthy insufficiently-active adults. Participants (64.3% female, M age = 45.5 ± 9.1 years, M BMI = 33.9 ± 7.3 kg/m 2 , 18.8% Hispanic, 84.0% White) were recruited from May 2016 to May 2018 from block groups ranked on GIS-measured neighborhood walkability and socioeconomic status (SES) and classified into four neighborhood types: ""high walkable/high SES,"" ""high walkable/low SES,"" ""low walkable/high SES,"" and ""low walkable/low SES."" Results from this ongoing study will provide evidence for some of the central research questions of ecological models.",2019,"Such technologies also allow for more precise delivery of ""smaller, sooner incentives"" that may result in greater MVPA than ""larger, later incentives"".","['adults from neighborhoods known to vary in neighborhood walkability', '512 healthy insufficiently-active adults', 'adults meeting moderate-to-vigorous physical activity (MVPA) guidelines', 'Participants (64.3% female, M age\u202f=\u202f45.5\u202f±\u202f9.1\u202fyears, M BMI\u202f=\u202f33.9\u202f±\u202f7.3\u202fkg/m 2 , 18.8% Hispanic, 84.0% White) were recruited from May 2016 to May 2018 from block groups ranked on GIS-measured neighborhood walkability and socioeconomic status (SES) and classified into four neighborhood types: ""high walkable/high SES,"" ""high walkable/low SES,"" ""low walkable/high SES,"" and ""low walkable/low SES', 'WalkIT Arizona']",['MVPA'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003787', 'cui_str': 'Arizona'}]",[],[],512.0,0.0312631,"Such technologies also allow for more precise delivery of ""smaller, sooner incentives"" that may result in greater MVPA than ""larger, later incentives"".","[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Adams', 'Affiliation': 'College of Health Solutions, Arizona State University, 425 N. 5(th) Street, Phoenix, AZ 85004, United States of America. Electronic address: Marc.Adams@asu.edu.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Hurley', 'Affiliation': 'College of Health Solutions, Arizona State University, 425 N. 5(th) Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Phillips', 'Affiliation': 'College of Health Solutions, Arizona State University, 425 N. 5(th) Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'College of Nursing and Health Innovations, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Siddhartha S', 'Initials': 'SS', 'LastName': 'Angadi', 'Affiliation': 'College of Health Solutions, Arizona State University, 425 N. 5(th) Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Berardi', 'Affiliation': 'Department of Psychology, Crean School of Health and Behavioral Sciences, Chapman University, One University Drive, Orange, CA 92866, United States of America.'}, {'ForeName': 'Melbourne F', 'Initials': 'MF', 'LastName': 'Hovell', 'Affiliation': 'College of Health and Human Services, San Diego State University, San Diego, CA 92182-4124, United States of America.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hooker', 'Affiliation': 'College of Health and Human Services, San Diego State University, San Diego, CA 92182-4124, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.05.001']
1281,31062207,Effect of Therapeutic Touch on Sleep Quality in Elders Living at Nursing Homes.,"This study was carried out to investigate the effect of therapeutic touch on sleep quality in the elderly people living in the nursing homes. The study is a randomized controlled experimental study (pretest-posttest control group). The sample of the research consisted of 25 elderly people. As a result of the study, although there was a significant increase (p < 0.05) in the sleep quality of each group, no significant difference was found between the groups (p > 0.05). Therapeutic touch is an effective method of improving the sleep quality of the elders living at a nursing home.",2020,"As a result of the study, although there was a significant increase (p < 0.05) in the sleep quality of each group, no significant difference was found between the groups (p > 0.05).","['elderly people living in the nursing homes', 'Elders Living at Nursing Homes', '25 elderly people', 'elders living at a nursing home']",['Therapeutic Touch'],"['Sleep Quality', 'sleep quality']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",25.0,0.0148947,"As a result of the study, although there was a significant increase (p < 0.05) in the sleep quality of each group, no significant difference was found between the groups (p > 0.05).","[{'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Bağcı', 'Affiliation': 'Department of Fundamentals Nursing, Ege University Nursing School, 35000, Izmir, Turkey. hazelbagci@hotmail.com.'}, {'ForeName': 'Şebnem', 'Initials': 'Ş', 'LastName': 'Çınar Yücel', 'Affiliation': 'Department of Fundamentals Nursing, Ege University Nursing School, 35000, Izmir, Turkey.'}]",Journal of religion and health,['10.1007/s10943-019-00831-9']
1282,31734931,"Impact of different modes of school dental health education on oral health-related knowledge, attitude and practice behaviour: an interventional study.","PURPOSE
The study was planned to evaluate the effectiveness of three modes of school dental health education (SDHE) on the oral health-related knowledge, attitude and practice (KAP) behaviour of school children.
METHODS
An interventional study was carried out among 8-9 year old school children from January 2016 to January 2018. Three hundred and sixty children from three schools in Tiruchengode, Tamil Nadu, India participated in this study. Each school was randomly allotted with a mode (drama, modified snake and ladder game, flashcard) of SDHE, which was delivered for 20 min, every 6 months for 2 years. A validated questionnaire with 18 questions was used to record oral health-related KAP behaviour at baseline and after 2 years.
RESULTS
At the end of 2 years, there was an increase in the percentage of correct response for all the nine knowledge questions, in all the three modes. The mean difference in the cumulative knowledge score between baseline and 2 years was 1.39 ± 2.05 for drama mode, 1.8 ± 1.51 for game mode and 1.7 ± 1.5 for flashcard mode of SDHE. There was a significant difference in three knowledge questions and one attitude practice behaviour question between the three groups at the end of 2 years.
CONCLUSIONS
All the three modes were effective in improving the oral health-related KAP behaviour of school children. Game mode made a better impact on the knowledge scores of these children, and it was observed to be more child-friendly and entertaining.",2020,"At the end of 2 years, there was an increase in the percentage of correct response for all the nine knowledge questions, in all the three modes.","['school children', '8-9\xa0year old school children from January 2016 to January 2018', 'Three hundred and sixty children from three schools in Tiruchengode, Tamil Nadu, India participated in this study']","['school dental health education', 'school dental health education (SDHE']","['oral health-related knowledge, attitude and practice behaviour', 'knowledge questions and one attitude practice behaviour question', 'cumulative knowledge score', 'percentage of correct response']","[{'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0337946', 'cui_str': 'Tamils (ethnic group)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018703', 'cui_str': 'Health Education, Dental'}]","[{'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",360.0,0.0152297,"At the end of 2 years, there was an increase in the percentage of correct response for all the nine knowledge questions, in all the three modes.","[{'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'GeethaPriya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, 637215, India. drgppedo@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Asokan', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, 637215, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kandaswamy', 'Affiliation': 'Faculty of Dental Sciences, Sri Ramachandra University, Porur, Chennai, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shyam', 'Affiliation': 'Department of Public Health Dentistry, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu, India.'}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-019-00489-7']
1283,31074333,Design and analysis of stratified clinical trials in the presence of bias.,"BACKGROUND
Among various design aspects, the choice of randomization procedure have to be agreed on, when planning a clinical trial stratified by center. The aim of the paper is to present a methodological approach to evaluate whether a randomization procedure mitigates the impact of bias on the test decision in clinical trial stratified by center.
METHODS
We use the weighted t test to analyze the data from a clinical trial stratified by center with a two-arm parallel group design, an intended 1:1 allocation ratio, aiming to prove a superiority hypothesis with a continuous normal endpoint without interim analysis and no adaptation in the randomization process. The derivation is based on the weighted t test under misclassification, i.e. ignoring bias. An additive bias model combing selection bias and time-trend bias is linked to different stratified randomization procedures.
RESULTS
Various aspects to formulate stratified versions of randomization procedures are discussed. A formula for sample size calculation of the weighted t test is derived and used to specify the tolerated imbalance allowed by some randomization procedures. The distribution of the weighted t test under misclassification is deduced, taking the sequence of patient allocation to treatment, i.e. the randomization sequence into account. An additive bias model combining selection bias and time-trend bias at strata level linked to the applied randomization sequence is proposed. With these before mentioned components, the potential impact of bias on the type one error probability depending on the selected randomization sequence and thus the randomization procedure is formally derived and exemplarily calculated within a numerical evaluation study.
CONCLUSION
The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design. It enables the choice of the best practice procedure. The evaluation stimulates the discussion about the level of evidence resulting in those kind of clinical trials.",2020,The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design.,[],[],['tolerated imbalance'],[],[],[],,0.0810538,The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design.,"[{'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hilgers', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Manolov', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Heussen', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Statistics, George Mason University, Fairfax, VA, USA.'}]",Statistical methods in medical research,['10.1177/0962280219846146']
1284,31734761,Split-face comparison of the picosecond 1064-nm Nd:YAG laser using a microlens array and the quasi-long-pulsed 1064-nm Nd:YAG laser for treatment of photoaging facial wrinkles and pores in Asians.,"Skin photoaging manifests deeper wrinkles and larger pore size. Various lasers have been tried for rejuvenation of photoaging skin, and the quasi-long-pulsed 1064-nm neodymium:yttrium-aluminum-garnet (Nd:YAG) laser is one promising treatment option. New types of laser device are emerging, including devices operating with picosecond pulse duration combined with a microlens array, which are regarded as a new breakthrough for skin rejuvenation. We aimed to evaluate the clinical effectiveness and safety of the picosecond 1064-nm Nd:YAG laser using a microlens array compared with the quasi-long-pulsed 1064-nm Nd:YAG laser in a split-face design. We designed a split-faced, prospective study and enrolled 25 subjects with photoaging facial wrinkles and enlarged pores. Each facial area was randomly assigned to undergo treatment with either the picosecond 1064-nm Nd:YAG laser (Pico-arm) or the quasi-long-pulsed 1064-nm Nd:YAG laser (Quasi-arm). We performed five laser sessions at 2-week intervals, and final results were assessed after 20 weeks after the initial laser session. We used a five-point global assessment scale, wrinkle and pore index derived from 3D camera analysis. We enrolled a total of 25 subjects (24 females and 1 male) with Fitzpatrick skin types III to IV and a mean age of 63.8 ± 5.7 years. After treatment, 54.2% of subjects in the Pico-arm reported at least moderate improvement in visible pores compared with 41.7% of the Quasi-arm (P = 0.001). A total of 12.5% of subjects in the Pico-arm showed moderate improvement in wrinkles versus 4.2% of the Quasi-arm (P = 0.125). There was a 41.3% reduction in the pore index in the Pico-arm compared to a 3.9% increase in the Quasi-arm (P = 0.048). There was a 16.4% reduction in the wrinkle index in the Pico-arm compared with a 0.5% reduction in the Quasi-arm (P = 0.01). Pain assessment score was higher in the Pico-arm than the Quasi-arm (3.65 ± 1.70 vs 1.28 ± 1.28, P = 0.001). No serious adverse events occurred during the study. Our findings suggest that the picosecond 1064-nm Nd:YAG laser with a microlens array is as effective as the quasi-long-pulsed 1064-nm Nd:YAG laser for treatment of photoaging wrinkles and pores.",2020,There was a 16.4% reduction in the wrinkle index in the Pico-arm compared with a 0.5% reduction in the Quasi-arm (P = 0.01).,"['enrolled 25 subjects with photoaging facial wrinkles and enlarged pores', 'photoaging facial wrinkles and pores in Asians', '25 subjects (24 females and 1 male) with Fitzpatrick skin types III to IV and a mean age of 63.8 ± 5.7 years']","['Nd:YAG laser (Pico-arm) or the quasi-long-pulsed 1064-nm', 'neodymium:yttrium-aluminum-garnet', 'YAG laser', 'picosecond 1064-nm Nd:YAG laser using a microlens array compared with the quasi-long-pulsed 1064-nm Nd:YAG laser', 'picosecond 1064-nm Nd:YAG laser using a microlens array and the quasi-long-pulsed 1064-nm', 'Nd:YAG laser', 'Nd:YAG']","['visible pores', 'Pain assessment score', 'moderate improvement in wrinkles', 'pore index', 'wrinkle index', 'serious adverse events']","[{'cui': 'C0263415', 'cui_str': 'Solar degeneration (disorder)'}, {'cui': 'C0262478', 'cui_str': 'Wrinkled face (finding)'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}]","[{'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",25.0,0.0200192,There was a 16.4% reduction in the wrinkle index in the Pico-arm compared with a 0.5% reduction in the Quasi-arm (P = 0.01).,"[{'ForeName': 'Sunmin', 'Initials': 'S', 'LastName': 'Yim', 'Affiliation': 'Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 03181, 29 Saemunan-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Yun Ho', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 03181, 29 Saemunan-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Jun', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 03181, 29 Saemunan-ro, Jongno-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Won-Serk', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 03181, 29 Saemunan-ro, Jongno-gu, Seoul, Republic of Korea. susini@naver.com.'}]",Lasers in medical science,['10.1007/s10103-019-02906-1']
1285,31066177,"Incidence, prevalence, and predictors of treatment-resistant hypertension with intensive blood pressure lowering.","Recent guidelines call for more intensive blood pressure (BP)-lowering and a less-stringent treatment-resistant hypertension (TRH) definition, both of which may increase the occurrence of this high-risk phenotype. We performed a post hoc analysis of 11 784 SPRINT and ACCORD-BP participants without baseline TRH, who were randomized to an intensive (<120 mm Hg) or standard (<140 mm Hg) systolic BP target. Incidence, prevalence, and predictors of TRH were compared using the updated definition (requiring ≥4 drugs to achieve BP < 130/80 mm Hg) during intensive treatment, vs the former definition (requiring ≥4 drugs to achieve BP < 140/90 mm Hg) during standard treatment. Incidence/prevalence of apparent refractory hypertension (RFH; uncontrolled BP despite ≥5 drugs) was similarly compared. Overall, 5702 and 6082 patients were included in the intensive and standard treatment cohorts, respectively. Crude TRH incidence using the updated definition under intensive treatment was 30.3 (95% CI, 29.3-31.4) per 100 patient-years, compared with 9.7 (95% CI, 9.2-10.2) using the prior definition under standard treatment. Point prevalence using the prior TRH definition at 1-year was 7.5% in SPRINT and 14% in ACCORD vs 22% and 36%, respectively, with the updated TRH definition. Significant predictors of incident TRH included number of baseline antihypertensive drugs, having diabetes, baseline systolic BP, and Black race. Incidence of apparent RFH was also significantly greater using the updated vs prior definition (4.5 vs 1.0 per 100 person-years). Implementation of the 2017 hypertension guideline, including lower BP goals for most individuals, is expected to substantially increase treatment burden and incident TRH among the hypertensive population.",2019,Incidence of apparent RFH was also significantly greater using the updated vs prior definition (4.5 vs 1.0 per 100 person-years).,"['5702 and 6082 patients were included in the intensive and standard treatment cohorts, respectively', '11\xa0784 SPRINT and ACCORD-BP participants without baseline TRH, who were randomized to an intensive (<120\xa0mm\xa0Hg) or standard (<140\xa0mm']",[],"['number of baseline antihypertensive drugs, having diabetes, baseline systolic BP, and Black race', 'Incidence, prevalence, and predictors of treatment-resistant hypertension with intensive blood pressure lowering', 'Crude TRH incidence', 'Hg) systolic BP target', 'Incidence of apparent RFH', 'Incidence, prevalence, and predictors of TRH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}]",,0.131972,Incidence of apparent RFH was also significantly greater using the updated vs prior definition (4.5 vs 1.0 per 100 person-years).,"[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacotherapy & Translational Research, College of Pharmacy, Gainesville, Florida.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes & Biomedical Informatics, College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Almut G', 'Initials': 'AG', 'LastName': 'Winterstein', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, Gainesville, Florida.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Cooper-DeHoff', 'Affiliation': 'Department of Pharmacotherapy & Translational Research, College of Pharmacy, Gainesville, Florida.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13550']
1286,31056442,Virtual Reality Simulation Facilitates Resident Training in Total Hip Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND
No study has yet assessed the efficacy of virtual reality (VR) simulation for teaching orthopedic surgery residents. In this blinded, randomized, and controlled trial, we asked if the use of VR simulation improved postgraduate year (PGY)-1 orthopedic residents' performance in cadaver total hip arthroplasty and if the use of VR simulation had a preferentially beneficial effect on specific aspects of surgical skills or knowledge.
METHODS
Fourteen PGY-1 orthopedic residents completed a written pretest and a single cadaver total hip arthroplasty (THA) to establish baseline levels of knowledge and surgical ability before 7 were randomized to VR-THA simulation. All participants then completed a second cadaver THA and retook the test to assess for score improvements. The primary outcomes were improvement in test and cadaver THA scores.
RESULTS
There was no significant difference in the improvement in test scores between the VR and control groups (P = .078). In multivariate regression analysis, the VR cohort demonstrated a significant improvement in overall cadaver THA scores (P = .048). The VR cohort demonstrated greater improvement in each specific score category compared with the control group, but this trend was only statistically significant for technical performance (P = .009).
CONCLUSIONS
VR-simulation improves PGY-1 resident surgical skills but has no significant effect on medical knowledge. The most significant improvement was seen in technical skills. We anticipate that VR simulation will become an indispensable part of orthopedic surgical education, but further study is needed to determine how best to use VR simulation within a comprehensive curriculum.
LEVEL OF EVIDENCE
Level 1.",2019,There was no significant difference in the improvement in test scores between the VR and control groups (P = .078).,"['teaching orthopedic surgery residents', 'Fourteen PGY-1 orthopedic residents completed a', 'Total Hip Arthroplasty', ""postgraduate year (PGY)-1 orthopedic residents' performance in cadaver total hip arthroplasty""]","['virtual reality (VR) simulation', 'written pretest and a single cadaver total hip arthroplasty (THA', 'VR simulation', 'Virtual Reality Simulation Facilitates', 'Resident Training']","['medical knowledge', 'improvement in test and cadaver THA scores', 'specific score category', 'technical skills', 'test scores', 'overall cadaver THA scores', 'technical performance']","[{'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",14.0,0.05656,There was no significant difference in the improvement in test scores between the VR and control groups (P = .078).,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hooper', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Tsiridis', 'Affiliation': 'Aristotle University Medical School, Department of Orthopedic Surgery, Papageorgiou General Hospital, Thessaloniki, Hellas; Center of Orthopaedics and Regenerative Medicine (C.O.RE.)- C.I.R.I.-A.U.Th., Balkan Center, Hellas, Greece.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Schwarzkopf', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Waren', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Long', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'Lazaros', 'Initials': 'L', 'LastName': 'Poultsides', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Macaulay', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.002']
1287,31351667,Re: Multicenter Prospective Phase II Trial of Neoadjuvant Dose-dense Gemcitabine Plus Cisplatin in Patients with Muscle-invasive Bladder Cancer.,,2019,,['Patients with Muscle-invasive Bladder Cancer'],['Neoadjuvant Dose-dense Gemcitabine Plus Cisplatin'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]",[],,0.0142864,,"[{'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Voskuilen', 'Affiliation': 'Department of Surgical Oncology (Urology), Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Michiel S', 'Initials': 'MS', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Bas W G', 'Initials': 'BWG', 'LastName': 'van Rhijn', 'Affiliation': 'Department of Surgical Oncology (Urology), Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands. Electronic address: b.v.rhijn@nki.nl.'}]",European urology,['10.1016/j.eururo.2019.07.019']
1288,31736378,The effect of an mHealth intervention for titration of insulin for type 2 diabetes: A pilot study.,"BACKGROUND
Stabilising blood glucose levels (BGL) after starting or changing insulin and related therapies can be challenging for diabetes services and the patient with type 2 diabetes. Traditionally, a credentialled diabetes educator (CDE) would talk with the patient over the phone to obtain a history of their BGLs over the previous week and provide advice on the insulin dose adjustments as required. This study trialled a smartphone application for sharing BGLs, with the ability to digitally transmit advice back to patients compared with their usual care.
AIMS
The aim of this study was to compare desirability, efficiency and ease of use.
METHODS
Participants were enrolled in either the traditional ( n =50) or Health2Sync (H2S) ( n =42) treatment group by patient preference. All insulin stabilisations were conducted by the CDE. Descriptive statistics were used for analysis.
RESULTS
The average total time taken to titrate patients was similar in both groups ( p >0.05), however there were fewer failure of contacts reported with H2S ( p <0.01) and time per interaction was also lower ( p <0.01). Sensitivity analysis revealed that, excluding the influence of no contacts, H2S patients had a lower average time for titration ( p <0.01). There was no difference in clinical outcomes as measured by HbA 1c between the two groups ( p =0.75).
CONCLUSION
We demonstrated a high acceptance and clinical utility of the H2S application. Clinicians were happy to use H2S and found it easy and convenient for most patients. Importantly, this reduced frequency of contacts with patients, time per interaction and average time for titration ( p <0.01). Patient selection for this communication intervention is important.",2020,"There was no difference in clinical outcomes as measured by HbA 1c between the two groups ( p =0.75).
","['type 2 diabetes', 'Participants were enrolled in either the traditional ( n =50) or Health2Sync (H2S) ( n =42) treatment group by patient preference']",['mHealth intervention'],"['average total time taken', 'time per interaction', 'average time for titration', 'time per interaction and average time for titration', 'clinical outcomes', 'desirability, efficiency and ease of use']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0199689,"There was no difference in clinical outcomes as measured by HbA 1c between the two groups ( p =0.75).
","[{'ForeName': 'Siân E', 'Initials': 'SE', 'LastName': 'Bramwell', 'Affiliation': 'Western Sydney Diabetes (WSD), Integrated and Community Health Directorate, Department of Endocrinology and Diabetes, Blacktown Hospital, Western Sydney Local Health District, Australia.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Meyerowitz-Katz', 'Affiliation': 'Western Sydney Diabetes (WSD), Integrated and Community Health Directorate, Department of Endocrinology and Diabetes, Blacktown Hospital, Western Sydney Local Health District, Australia.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Ferguson', 'Affiliation': 'Western Sydney Nursing & Midwifery Research Centre, Western Sydney Local Health District, Western Sydney University, Australia.'}, {'ForeName': 'Rajini', 'Initials': 'R', 'LastName': 'Jayaballa', 'Affiliation': 'Western Sydney Diabetes (WSD), Integrated and Community Health Directorate, Department of Endocrinology and Diabetes, Blacktown Hospital, Western Sydney Local Health District, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McLean', 'Affiliation': 'Western Sydney Diabetes (WSD), Integrated and Community Health Directorate, Department of Endocrinology and Diabetes, Blacktown Hospital, Western Sydney Local Health District, Australia.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Maberly', 'Affiliation': 'Western Sydney Diabetes (WSD), Integrated and Community Health Directorate, Department of Endocrinology and Diabetes, Blacktown Hospital, Western Sydney Local Health District, Australia.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119889764']
1289,31056229,"Reply to Satoru Taguchi, Tohru Nakagawa, and Hiroshi Fukuhara's Letter to the Editor re: Jürgen E. Gschwend, Matthias M. Heck, Jan Lehmann, et al. Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial. Eur Urol 2019;75:604-11.",,2019,,['Bladder Cancer Patients'],['Radical Cystectomy'],[],"[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]",[],,0.0392024,,"[{'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Department of Urology, Technical University of Munich, Munich, Germany. Electronic address: juergen.gschwend@tum.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Heck', 'Affiliation': 'Department of Urology, Technical University of Munich, Munich, Germany.'}]",European urology,['10.1016/j.eururo.2019.04.032']
1290,30992235,Orally inhaled levodopa (CVT-301) for early morning OFF periods in Parkinson's disease.,"BACKGROUND
CVT-301 (Inbrija) is a self-administered orally inhaled levodopa approved for the intermittent treatment of OFF episodes in patients with Parkinson's disease (PD) treated with carbidopa/levodopa. Prior studies only evaluated CVT-301 after the first ON of the day.
OBJECTIVE AND METHODS
The objective of this study was to evaluate the safety and tolerability of CVT-301 for early morning OFF. Using a randomized, double-blind, 2-way crossover design, eligible patients in the morning OFF state (having not received PD medication overnight) received a single dose of CVT-301 84 mg or placebo on 2 dosing days, immediately after their first morning oral carbidopa/levodopa dose. Safety assessments included treatment-emergent adverse events, vital signs, and patient- and examiner-reported dyskinesia. An exploratory efficacy assessment was examiner-rated time-to-ON with carbidopa/levodopa + CVT-301 vs carbidopa/levodopa + placebo.
RESULTS
Of the 36 patients (mean age 62.9 years) who enrolled and completed the study, 9 (25.0%) reported treatment-emergent adverse events following CVT-301 administration; 4 (11.1%) reported treatment-emergent adverse events following placebo. The most common adverse event was cough (4 [11.1%] for CVT-301 vs 1 [2.8%] for placebo), which was typically mild and transient. Incidence of asymptomatic orthostatic hypotension (CVT-301, 6; placebo, 7) and examiner-rated dyskinesia were similar for both (36-39% mild, 3-6% moderate, and 0% severe). Median time-to-ON was 25.0 min following carbidopa/levodopa + CVT-301 and 35.5 min following carbidopa/levodopa + placebo (P = 0.26). At 30 min, more patients had turned ON following carbidopa/levodopa + CVT-301 administration (66.7%), compared with carbidopa/levodopa + placebo (44.5%) (P = 0.040).
CONCLUSION
Single doses of CVT-301 84 mg administered with oral carbidopa/levodopa for early morning OFF symptoms were well-tolerated, with no notable safety concerns.",2019,"At 30 min, more patients had turned ON following carbidopa/levodopa + CVT-301 administration (66.7%), compared with carbidopa/levodopa + placebo (44.5%) (P = 0.040).
","[""Parkinson's disease"", '36 patients (mean age 62.9 years', 'eligible patients in the morning OFF state (having not received PD medication overnight', ""patients with Parkinson's disease (PD) treated with""]","['CVT-301 84\xa0mg or placebo', 'Orally inhaled levodopa (CVT-301', 'placebo', 'carbidopa/levodopa', 'CVT-301 vs carbidopa/levodopa\xa0+\xa0placebo', 'levodopa', 'carbidopa/levodopa dose', 'CVT-301', 'carbidopa/levodopa\xa0', 'CVT-301 84\u202fmg administered with oral carbidopa/levodopa', 'carbidopa/levodopa\xa0+\xa0placebo']","['safety and tolerability', 'treatment-emergent adverse events', 'Incidence of asymptomatic orthostatic hypotension', 'examiner-rated dyskinesia', 'Median time-to-ON', 'Safety assessments included treatment-emergent adverse events, vital signs, and patient- and examiner-reported dyskinesia']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa / Levodopa'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.590591,"At 30 min, more patients had turned ON following carbidopa/levodopa + CVT-301 administration (66.7%), compared with carbidopa/levodopa + placebo (44.5%) (P = 0.040).
","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida, Tampa, FL, USA. Electronic address: rhauser@health.usf.edu.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ellenbogen', 'Affiliation': 'Quest Research Institute, Bingham Farms, MI, USA.'}, {'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Safirstein', 'Affiliation': 'MD Clinical, Hallandale Beach, FL, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Truong', 'Affiliation': 'The Truong Neuroscience Institute, Orange Coast Memorial Medical Center, Fountain Valley, CA, USA; Department of Psychiatry and Neuroscience, University of California Riverside, Riverside, CA, USA.'}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Komjathy', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': 'Deena M', 'Initials': 'DM', 'LastName': 'Kegler-Ebo', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.03.026']
1291,29960810,Clinical intervention using Bifidobacterium strains in celiac disease children reveals novel microbial modulators of TNF-α and short-chain fatty acids.,"BACKGROUND & AIMS
Celiac disease (CD) is an immune-mediated systemic disease, caused by ingestion of gluten in genetically predisposed individuals. Gut microbiota dysbiosis might play a significant role in pathogenesis of chronic enteropathies and its modulation can be used as an intervention strategy in CD as well. In this study, we aimed to identify correlations between fecal microbiota, serum tumor necrosis factor alpha (TNF-α) and fecal short-chain fatty acids (SCFAs) in healthy children and children with CD after administration of probiotic Bifidobacterium breve BR03 and B632.
METHODS
A double-blind placebo-controlled study enrolled 40 children with CD (CD) and 16 healthy children (HC). CD children were randomly allocated into two groups, of which 20 belonged to the placebo (PL) group and 20 to the Probiotic (PR) group. The PR group received a probiotic formulation containing a mixture of 2 strains, B. breve BR03 (DSM 16604) and B. breve B632 (DSM 24706) in 1:1 ratio for 3 months. Subsequently, for statistical analysis, blood and fecal samples from CD children (on enrolment - T0 and after 3 months, at the end of intervention with probiotic/placebo - T1) and HC children were used. The HC group was sampled only once (T0).
RESULTS
Verrucomicrobia, Parcubacteria and some yet unknown phyla of Bacteria and Archaea may be involved in the disease, indicated by a strong correlation to TNF-α. Likewise, Proteobacteria strongly correlated with fecal SCFAs concentration. The effect of probiotic administration has disclosed a negative correlation between Verrucomicrobia, some unknown phyla of Bacteria, Synergistetes, Euryarchaeota and some SCFAs, turning them into an important target in microbiome restoration process. Synergistetes and Euryarchaeota may have a role in the anti-inflammatory process in healthy human gut.
CONCLUSIONS
Our results highlight new phyla, which may have an important relation to disease-related parameters, CD itself and health.",2019,"The effect of probiotic administration has disclosed a negative correlation between Verrucomicrobia, some unknown phyla of Bacteria, Synergistetes, Euryarchaeota and some SCFAs, turning them into an important target in microbiome restoration process.","['celiac disease children', 'CD children', 'healthy children and children with CD after administration of probiotic Bifidobacterium breve BR03 and B632', 'healthy human gut', '40 children with CD (CD) and 16 healthy children (HC']","['placebo (PL) group and 20 to the Probiotic (PR', 'probiotic formulation', 'placebo']","['fecal SCFAs concentration', 'fecal microbiota, serum tumor necrosis factor alpha (TNF-α) and fecal short-chain fatty acids (SCFAs']","[{'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}]",40.0,0.0307711,"The effect of probiotic administration has disclosed a negative correlation between Verrucomicrobia, some unknown phyla of Bacteria, Synergistetes, Euryarchaeota and some SCFAs, turning them into an important target in microbiome restoration process.","[{'ForeName': 'Maša', 'Initials': 'M', 'LastName': 'Primec', 'Affiliation': 'Department of Microbiology, Biochemistry, Molecular Biology and Biotechnology, Faculty of Agriculture and Life Sciences, University of Maribor, Pivola 10, 2311 Hoče, Slovenia. Electronic address: masa.primec@um.si.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Klemenak', 'Affiliation': 'Department of Pediatrics, University Clinical Center Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia. Electronic address: martina.klemenak@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Di Gioia', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, 40127 Bologna, Italy. Electronic address: diana.digioia@unibo.it.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Aloisio', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, 40127 Bologna, Italy. Electronic address: irene.aloisio@unibo.it.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bozzi Cionci', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, 40127 Bologna, Italy. Electronic address: nicole.bozzicionci@studio.unibo.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Quagliariello', 'Affiliation': 'Human Microbiome Unit, Bambino Gesù Children Hospital, IRCCS, Viale di San Paolo 15, 00146 Rome, Italy. Electronic address: andrea.quagliariello@opbg.net.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gorenjak', 'Affiliation': 'Centre for Human Molecular Genetics and Pharmacogenomics, Department of Biochemistry and Nutrition, Faculty of Medicine, Taborska ulica 8, 2000 Maribor, Slovenia. Electronic address: mario.gorenjak@um.si.'}, {'ForeName': 'Dušanka', 'Initials': 'D', 'LastName': 'Mičetić-Turk', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Maribor, Taborska ulica 8, 2000 Maribor, Slovenia. Electronic address: dusanka.micetic@um.si.'}, {'ForeName': 'Tomaž', 'Initials': 'T', 'LastName': 'Langerholc', 'Affiliation': 'Department of Microbiology, Biochemistry, Molecular Biology and Biotechnology, Faculty of Agriculture and Life Sciences, University of Maribor, Pivola 10, 2311 Hoče, Slovenia. Electronic address: tomaz.langerholc@um.si.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.06.931']
1292,31852355,Year-round treatment initiation for a 6-grasses pollen allergoid in specific immunotherapy of allergic rhinoconjunctivitis and asthma.,"Aim: Allergen immunotherapy (AIT) is an effective treatment for allergic diseases. We investigate whether treatment-initiation during the pollen season is safe. Methods: RCT-IIIb-trial of 6-grass-pollen-allergoid (Allergovit ® ) in grass pollen-allergic patients (18-65 years) with moderate-severe rhinitis/rhinoconjunctivitis (± controlled asthma), randomized 2:1 to treatment-initiation during (Group-A) versus outside the pollen season (Group-B). Results: Of 240 patients (32.8 ± 9.9 years, 19.5% asthma) treated, 84.9% (Group-A) and 86.6% (Group-B) reached maintenance dose without delay. Treatment-emergent adverse events occurred in 108 (68.4%/Group-A) and 41 patients (56.2%/Group-B) leading to premature trial-termination in 11 patients (7%/A) versus 3 (4.1%/B). Across groups, physicians (for 190 patients; 85.2%) and patients (192; 86.1%) rated the tolerability as 'very good'-'good'. Phleum pratense -specific IgG4 increased in both groups (p < 0.0001). Conclusion: Year-round allergen immunotherapy-initiation with this preparation is safe.",2019,IgG4 increased in both groups (p < 0.0001). ,"['grass pollen-allergic patients (18-65 years) with moderate-severe rhinitis/rhinoconjunctivitis (±\xa0controlled asthma', '240 patients (32.8\xa0±\xa09.9 years, 19.5% asthma']","['Phleum pratense -specific', 'Allergen immunotherapy (AIT', '6-grass-pollen-allergoid (Allergovit ® ']",['IgG4'],"[{'cui': 'C0440307', 'cui_str': 'Grass pollen (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C1123001', 'cui_str': 'Phleum pratense (organism)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0162352', 'cui_str': 'Allergen Immunotherapy'}, {'cui': 'C0440307', 'cui_str': 'Grass pollen (substance)'}, {'cui': 'C0051199', 'cui_str': 'Allergoid'}, {'cui': 'C0390079', 'cui_str': 'allergovit'}]","[{'cui': 'C0020860', 'cui_str': 'IgG4'}]",240.0,0.147675,IgG4 increased in both groups (p < 0.0001). ,"[{'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Mahler', 'Affiliation': 'Department of Dermatology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zielen', 'Affiliation': 'Department for Children & Adolescents, Division for Allergology, Pneumology & Cystic Fibrosis, University Hospital Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rosewich', 'Affiliation': 'Department for Children & Adolescents, Division for Allergology, Pneumology & Cystic Fibrosis, University Hospital Goethe University, Frankfurt am Main, Germany.'}]",Immunotherapy,['10.2217/imt-2019-0086']
1293,31860209,Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate and Severe Acne Vulgaris in Females: Effect of Age on Efficacy and Tolerability,"BACKGROUND: While it is generally considered to be a disease of adolescence, acne affects an increasing number of adults, especially women. Although data exist on the use of retinoids in adult females, there is no universal agreement as to the age of onset of adult female acne, or data on the efficacy and tolerability dependent on age. A novel tretinoin 0.05% lotion formulation has been shown to be effective and well-tolerated in acne patients with moderate or severe disease.
OBJECTIVE: To evaluate the safety and efficacy of once-daily tretinoin 0.05% lotion in women with moderate or severe acne categorized into different age groups (13-19, 20-29, and 30+ years).
METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. Women (aged 13-19 years, N=357; 20-29 years, N=352; 30+ years, N=156) with moderate or severe acne were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory/noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and ‘clear’/’almost clear’) and Quality of Life (QoL) using the validated Acne-QoL questionnaire. Safety and adverse events (AEs) where evaluated throughout; cutaneous tolerability assessed at each study visit using a 4-point scale (where 0=none and 3=severe).
RESULTS: At baseline, 91.9% (N=794) of women in the post hoc analysis had moderate (EGSS=3) and 8.1% (N=70) severe (EGSS=4) acne, with the highest proportion of women (11.1%, N=39) having severe acne being aged 20-29 years. Baseline inflammatory lesion counts were similar across the three age ranges, with more comedonal lesions (44.5) in adolescent females (aged 13-19 years). Quality of life at baseline was much better in adolescent females and may be age-related for some domains (self-perception and role-social). At week 12, there appeared to be an age-related improvement in both inflammatory and noninflammatory lesion counts, and treatment success although the differences between groups were not significant. Mean percent reduction in inflammatory and noninflammatory lesion counts for each age group (13-19, 20-29, and 30+ years old respectively) were 55.3% (P=0.019 versus vehicle), 55.8% (P=0.080) and 63.5%; and 47.1% (P<0.001), 55.2% (P=0.002) and 59.0% (P=0.030). Treatment success for the 3 groups was achieved by 23.2% (P=0.023), 21.3%, and 30.7% of patients, respectively, at week 12; differences between age groups were not significant. Quality of Life improved in all age groups, although changes with tretinoin 0.05% lotion were only significant compared with vehicle in adult females aged 20-29 years (self-perception, role-emotional and acne symptoms); improvements in each domain score by week 12 were also greatest in this age group. The majority of AEs were mild and transient; the most common treatment emergent AEs were application site pain and dryness especially in the older adult females (aged 30+ years). Local cutaneous safety and tolerability assessments were generally mild and improved by week 12. There were transient increases in scaling, burning and stinging in the adolescent females, peaking at week 4; all mean scores were ≤0.6 where 1=mild.
CONCLUSIONS: Tretinoin 0.05% lotion was significantly more effective than vehicle in achieving treatment success and reducing inflammatory and comedonal lesions in adult and adolescent females with moderate or severe acne. There appear to be age-related efficacy and tolerability benefits favoring adult females.
J Drugs Dermatol. 2019;18(12):1218-1225.",2019,Tretinoin 0.05% lotion was significantly more effective than vehicle in achieving treatment success and reducing inflammatory and comedonal lesions in adult and adolescent females with moderate or severe acne.,"['older adult females (aged 30+ years', 'acne patients with moderate or severe disease', 'Moderate and Severe Acne Vulgaris in Females', 'adolescent females', 'adult females', 'women with moderate or severe acne categorized into different age groups (13-19, 20-29, and 30+ years', 'adolescent females (aged 13-19 years', 'adult females aged 20-29 years', 'Women (aged 13-19 years, N=357; 20-29 years, N=352; 30+ years, N=156) with moderate or severe acne', 'adult and adolescent females with moderate or severe acne']","['tretinoin 0.05% lotion', 'Tretinoin 0.05% lotion', 'Tretinoin 0.05% Lotion', 'tretinoin 0.05% lotion or vehicle']","['Baseline inflammatory lesion counts', 'baseline inflammatory/noninflammatory lesions and treatment success', 'Evaluator’s Global Severity Score [EGSS] and ‘clear’/’almost clear’) and Quality of Life (QoL) using the validated Acne-QoL questionnaire', 'inflammatory and comedonal lesions', 'efficacy and tolerability', 'Treatment success', 'Quality of Life', 'Efficacy and Tolerability', 'safety and efficacy', 'scaling, burning and stinging', 'Quality of life', 'Safety and adverse events (AEs', 'inflammatory and noninflammatory lesion counts', 'Local cutaneous safety and tolerability assessments']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0222045'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.143762,Tretinoin 0.05% lotion was significantly more effective than vehicle in achieving treatment success and reducing inflammatory and comedonal lesions in adult and adolescent females with moderate or severe acne.,"[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': ''}, {'ForeName': 'David M.', 'Initials': 'DM', 'LastName': 'Pariser', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guenin', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,[]
1294,31732883,Effect of CPP-ACP on Streptococcus mutans in saliva of high caries-risk preschool children: a randomized clinical trial.,"PURPOSE
The aim of this study was to assess the efficacy of CPP-ACP in reducing salivary S. mutans levels and compare its effect as a dentifrice to use of a fluoride dentifrice alone, or with the sequential use of a combination of both agents (fluoride, then CPP-ACP) in three groups of preschool children over a 6-month period.
METHODS
This was a double-blinded clinical trial, the sample (n = 127, age 4.6 ± 0.47 years), with high caries risk, was randomized into three groups which applied different agents twice daily; fluoride toothpaste (500 ppm, n = 50), CPP-ACP (10% w/v, n = 38), and combination group (n = 39) applied fluoride, then CPP-ACP. S. mutans salivary levels were measured by GC Saliva-Check Mutans ™ .
RESULTS
Within groups, a significant decrease in S. mutans-positive children (SMPC) occurred in fluoride and combination groups at 3-months, (P < 0.05), and in all groups at 6-months, (P < 0.05). The highest reduction in SMPC occurred in the CPP-ACP group, however, there were no significant differences in SMPC between groups at all study intervals, (P > 0.05).
CONCLUSION
Although all agents were effective, CPP-ACP showed the highest reduction in SMPC over 6-months.",2020,"Within groups, a significant decrease in S. mutans-positive children (SMPC) occurred in fluoride and combination groups at 3-months, (P < 0.05), and in all groups at 6-months, (P < 0.05).","['sample (n\u2009=\u2009127, age 4.6\u2009±\u20090.47\xa0years), with high caries risk', 'Streptococcus mutans in saliva of high caries-risk preschool children', 'three groups of preschool children over a 6-month period']","['CPP-ACP', 'agents (fluoride, then CPP-ACP', 'fluoride toothpaste', 'fluoride, then CPP-ACP']","['S. mutans-positive children (SMPC', 'salivary S. mutans levels', 'S. mutans salivary levels', 'SMPC']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0337399,"Within groups, a significant decrease in S. mutans-positive children (SMPC) occurred in fluoride and combination groups at 3-months, (P < 0.05), and in all groups at 6-months, (P < 0.05).","[{'ForeName': 'O B', 'Initials': 'OB', 'LastName': 'Al-Batayneh', 'Affiliation': 'Department of Preventive Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, PO Box 3030, Irbid, 22110, Jordan. olabt@just.edu.jo.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Al-Rai', 'Affiliation': 'Department of Preventive Dentistry, Jordan University of Science and Technology, PO Box 3030, Irbid, 22110, Jordan.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Khader', 'Affiliation': 'Department of Public Health and Epidemiology, Faculty of Medicine, Jordan University of Science and Technology, PO Box 3030, Irbid, 22110, Jordan.'}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-019-00490-0']
1295,30747308,Exemestane may be less detrimental than letrozole to bone health in women homozygous for the UGT2B17*2 gene deletion.,"PURPOSE
UGT2B17 gene deletion (UGT2B17*2) has been reported to affect bone health as well as the pharmacokinetics of aromatase inhibitor (AI) drugs such as exemestane. The goal of this study was to assess associations between UGT2B17 gene deletion and bone health prior to and after 24 months of AI treatment in postmenopausal women with hormone receptor positive (HR+) breast cancer.
METHODS
Bone health in women with HR+ breast cancer enrolled on the prospective randomized Exemestane and Letrozole Pharmacogenetics (ELPh) trial was determined by measuring bone turnover markers (BTM) and bone mineral density (BMD) pre-treatment and after 3 BTM and 24 BMD months of treatment with either the steroidal AI exemestane or the nonsteroidal AI letrozole. DNA samples were genotyped for UGT2B17*2.
RESULTS
Of the 455 subjects included in the analyses, 244 (53.6%) carried at least one copy of UGT2B17*2. UGT2B17*2 was associated with lower pre-treatment BMD at the hip (P = 0.01) and spine (P = 0.0076). Letrozole treatment was associated with a greater decrease in BMD of the hip (P = 0.03) and spine (P = 0.03) than exemestane. UGT2B17 genotype was not associated with changes in BMD from 24 months of AI treatment, though in UGT2B17*2 homozygous patients, there was a trend toward greater decreases in BMD of the spine from treatment with letrozole compared with exemestane (P = 0.05).
CONCLUSION
UGT2B17*2 may be associated with lower baseline BMD in women with HR+ breast cancer. Exemestane is less detrimental to bone health than letrozole in postmenopausal women treated with AI, and this effect may be confined to patients carrying UGT2B17*2, though this finding requires independent validation.",2019,Letrozole treatment was associated with a greater decrease in BMD of the hip (P = 0.03) and spine (P = 0.03) than exemestane.,"['Bone health in women with HR+ breast cancer enrolled on the prospective randomized', 'postmenopausal women treated with AI', 'women with HR+ breast cancer', 'postmenopausal women with hormone receptor positive (HR+) breast cancer']","['Letrozole', 'Exemestane', 'steroidal AI exemestane or the nonsteroidal AI letrozole', 'exemestane', 'Exemestane and Letrozole Pharmacogenetics (ELPh', 'letrozole']","['baseline BMD', 'BMD', 'bone health', 'lower pre-treatment BMD', 'bone turnover markers (BTM) and bone mineral density (BMD', 'BMD of the hip']","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]",455.0,0.0274893,Letrozole treatment was associated with a greater decrease in BMD of the hip (P = 0.03) and spine (P = 0.03) than exemestane.,"[{'ForeName': 'Landry K', 'Initials': 'LK', 'LastName': 'Kamdem', 'Affiliation': 'Department of Pharmaceutical Sciences, Harding University College of Pharmacy, Searcy, AR, 72149-2230, USA. lkamdem@harding.edu.'}, {'ForeName': 'Jingyue', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Brandi L', 'Initials': 'BL', 'LastName': 'Clark', 'Affiliation': 'Department of Pharmaceutical Sciences, Harding University College of Pharmacy, Searcy, AR, 72149-2230, USA.'}, {'ForeName': 'Bryana J', 'Initials': 'BJ', 'LastName': 'Gregory', 'Affiliation': 'Department of Pharmaceutical Sciences, Harding University College of Pharmacy, Searcy, AR, 72149-2230, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Storniolo', 'Affiliation': 'Melvin and Bren Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Stearns', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Gersch', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Rae', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hertz', 'Affiliation': 'Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-019-05158-3']
1296,31732558,Cervical Spine Involvement among Patients with Rheumatoid Arthritis Treated Actively with Treat-to-target Strategy: 10-year Results of the NEO-RACo Study.,"OBJECTIVE
To evaluate the development of radiological changes of the cervical spine in patients with rheumatoid arthritis (RA) in the NEO-RACo trial treated with an intensive, remission-targeted combination of conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and additional infliximab (IFX) or placebo (PLA) for the first 6 months.
METHODS
Ninety-nine patients with early, DMARD-naive RA were treated with a triple combination of csDMARD and prednisolone, and randomized to double-blindly receive either IFX (FIN-RACo+IFX) or PLA (FIN-RACo+PLA) infusions during the first 6 months. After 2 years the treatment strategies became unrestricted, but the treatment goal was strict NEO-RACo remission. At the 10-year visit, radiographs of the cervical spine were taken of 85 patients (38 in the FIN-RACo+IFX group and 47 in the FIN-RACo+PLA group). The study was registered at ClinicalTrials.gov (NCT00908089).
RESULTS
There were 4/85 patients (4.7%) with cervical spine involvement (CSI) by 10 years. Atlantoaxial subluxation was found in 2/85 patients (2.4%), both in the FIN-RACo+IFX group, and none in the FIN-RACo+PLA group. Atlantoaxial impaction was found in 1/85 patients (1.2%) in the FIN-RACo+IFX group. Subaxial subluxation was found in 1/85 patients (1.2%).
CONCLUSION
Early and intensive remission-targeted treatment has reduced the incidence of CSI and our results show that intensive treatment also prevents its development in the long run.",2019,Atlantoaxial impaction was found in 1/85 patients (1.2%) in the FIN-RACo+PLA group.,"['Ninety-nine patients with early, DMARD-naïve RA', 'patients with rheumatoid arthritis (RA) treated with intensive, remission-targeted combination of conventional synthetic (cs) disease modifying antirheumatic drugs (DMARDs) and additional', 'Patients with Rheumatoid Arthritis']","['FINRACo+ INFL', 'infliximab or placebo', 'triple combination of csDMARDs and prednisolone', 'infliximab (FIN-RACo+INFL) or placebo (FIN-RACo+PLA']","['Atlantoaxial subluxation', 'Subaxial subluxation', 'Atlantoaxial impaction']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0263905', 'cui_str': 'Subluxation of atlantoaxial joint (disorder)'}, {'cui': 'C0332768', 'cui_str': 'Joint Subluxations'}, {'cui': 'C0450192', 'cui_str': 'Atlantoaxial (qualifier value)'}, {'cui': 'C0333124', 'cui_str': 'Impaction (morphologic abnormality)'}]",99.0,0.0563874,Atlantoaxial impaction was found in 1/85 patients (1.2%) in the FIN-RACo+PLA group.,"[{'ForeName': 'Tia', 'Initials': 'T', 'LastName': 'Sandström', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Vappu', 'Initials': 'V', 'LastName': 'Rantalaiho', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Yli-Kerttula', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Malmi', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Karjalainen', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Uusitalo', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Julkunen', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Oili', 'Initials': 'O', 'LastName': 'Kaipiainen-Seppänen', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Paimela', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Puolakka', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Toini', 'Initials': 'T', 'LastName': 'Uutela', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Möttönen', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Hannonen', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Marjatta', 'Initials': 'M', 'LastName': 'Leirisalo-Repo', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Laasonen', 'Affiliation': 'From the Department of Rheumatology, and the Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki, Helsinki; Centre for Rheumatic Diseases, Tampere University Hospital; Faculty of Medicine and Health Technology, Tampere University, Tampere; Department of Rheumatology, Satakunta Central Hospital, Rauma; Primary Health Care Unit, Kuopio University Hospital, Kuopio; Folkhälsan Research Center, Helsinki; Department of Medicine, Seinäjoki Central Hospital, Seinäjoki; Department of Rheumatology, Oulu University Hospital and University of Oulu, Oulu; Department of Medicine, Hämeenlinna Central Hospital, Hämeenlinna; Department of Medicine, Kuopio University Hospital, Kuopio, Finland; Orton Orthopaedic Hospital, Helsinki; South Karelia Central Hospital, Lappeenranta; Department of Medicine, Lapland Central Hospital, Rovaniemi; School of Medicine, University of Turku, Turku; Department of Rheumatology, Central Hospital of Central Finland, Jyväskylä; Department of Rheumatology, Päijät-Häme Central Hospital, Lahti, Finland. This study was financially supported by the Competitive Research Funding of Tampere University Hospital, the Helsinki University Central Hospital Research Funds, Finska Läkaresällskapet, Liv och Hälsa, and the Finnish Society for Rheumatology. At baseline, an unrestricted grant was provided by Schering-Plough Finland, which was used for the purchase of infliximab. Schering-Plough Finland also provided support for investigator meetings. The funders did not have any role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish. T. Sandström, MD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; V. Rantalaiho, MD, PhD, Centre for Rheumatic Diseases, Tampere University Hospital, and Faculty of Medicine and Health Technology, Tampere University; T. Yli-Kerttula, MD, PhD, Department of Rheumatology, Satakunta Central Hospital; H. Kautiainen, BA, Primary Health Care Unit, Kuopio University Hospital, and Folkhälsan Research Center; T. Malmi, MD, Department of Medicine, Seinäjoki Central Hospital; A. Karjalainen, MD, PhD, Department of Rheumatology, Oulu University Hospital and University of Oulu; T. Uusitalo, MD, Department of Medicine, Hämeenlinna Central Hospital; H. Julkunen, MD, PhD, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; O. Kaipiainen-Seppänen, MD, PhD, Department of Medicine, Kuopio University Hospital; L. Paimela, MD, PhD, Orton Orthopaedic Hospital; K. Puolakka, MD, PhD, South Karelia Central Hospital; T. Uutela, MD, PhD, Department of Medicine, Lapland Central Hospital; T. Möttönen, MD, Professor, School of Medicine, University of Turku; P. Hannonen, MD, Professor, Department of Rheumatology, Central Hospital of Central Finland; M. Leirisalo-Repo, MD, Professor, Department of Rheumatology, Helsinki University Hospital and University of Helsinki; L. Laasonen, MD, PhD, Helsinki Medical Imaging Center, Helsinki University Hospital and University of Helsinki; M. Kauppi, MD, Professor, Faculty of Medicine and Health Technology, Tampere University, and Department of Rheumatology, Päijät-Häme Central Hospital. Address correspondence to Dr. T. Sandström, Department of Rheumatology, Helsinki University Hospital, PO Box 372, 00029 HUS, Finland. E-mail: tia.sandstrom@hus.fi. Accepted for publication November 5, 2019.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Kauppi', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of rheumatology,['10.3899/jrheum.190139']
1297,31553661,"Adjuvant Whole-Brain Radiation Therapy Compared With Observation After Local Treatment of Melanoma Brain Metastases: A Multicenter, Randomized Phase III Trial.","PURPOSE
The brain is a common site of metastasis for patients with high-risk melanoma. Although surgery or stereotactic radiosurgery are highly effective local treatments for a small number of metastases, there is a high risk of developing additional brain metastases. The role of adjuvant whole-brain radiotherapy (WBRT) in reducing new metastases is controversial, with a lack of high-level evidence specifically for melanoma.
METHODS
In this randomized phase III trial, patients who had local treatment of one to three melanoma brain metastases were randomly assigned to WBRT or observation. The primary end point was distant intracranial failure within 12 months, and secondary end points included time to intracranial failure, survival, and time to deterioration in performance status.
RESULTS
Between April 2009 and September 2017, 215 patients were randomly assigned from 24 centers. Median follow-up was 48.1 months (range, 39.6 to 68 months). Forty-two percent of patients in the WBRT group and 50.5% of those in the observation developed distant intracranial failure within 12 months (odds ratio, 0.71; 95% CI, 0.41 to 1.23; P = .22) and the rates over the entire follow-up period were 52.0% and 57.9%, respectively (odds ratio, 0.79; 95% CI, 0.45 to 1.36; P = .39). Local failure rate was lower after WBRT (20.0% v 33.6%; P = .03). At 12 months, 41.5% of patients in the WBRT group and 51.4% of patients in the observation group had died ( P = .28), with no difference in the rate of neurologic death. Median time to deterioration in performance status was 3.8 months after WBRT and 4.4 months with observation ( P = .32). WBRT was associated with more grade 1 to 2 acute toxicity.
CONCLUSION
After local treatment of one to three melanoma brain metastases, adjuvant WBRT does not provide clinical benefit in terms of distant intracranial control, survival, or preservation of performance status.",2019,Local failure rate was lower after WBRT (20.0% v 33.6%; P = .03).,"['patients who had local treatment of one to three melanoma brain metastases', 'patients with high-risk melanoma', 'Melanoma Brain Metastases', 'Between April 2009 and September 2017, 215 patients were randomly assigned from 24 centers']","['Observation', 'Adjuvant Whole-Brain Radiation Therapy', 'WBRT', 'WBRT or observation', 'adjuvant whole-brain radiotherapy (WBRT', 'stereotactic radiosurgery']","['Local failure rate', 'died', 'time to intracranial failure, survival, and time to deterioration in performance status', 'Median time to deterioration in performance status', 'distant intracranial failure', 'rate of neurologic death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",215.0,0.297748,Local failure rate was lower after WBRT (20.0% v 33.6%; P = .03).,"[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Hong', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Gerald B', 'Initials': 'GB', 'LastName': 'Fogarty', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Dolven-Jacobsen', 'Affiliation': 'Oslo University Hospital, The Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'Burmeister', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Serigne N', 'Initials': 'SN', 'LastName': 'Lo', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Haydu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Janette L', 'Initials': 'JL', 'LastName': 'Vardy', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'University of Western Australia, WA, Australia.'}, {'ForeName': 'Haryana M', 'Initials': 'HM', 'LastName': 'Dhillon', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Tasnia', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brindha', 'Initials': 'B', 'LastName': 'Shivalingam', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Menzies', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hruby', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Katharine J', 'Initials': 'KJ', 'LastName': 'Drummond', 'Affiliation': 'Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mandel', 'Affiliation': 'Swinburne University of Technology, Hawthorn, VIC, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'National Institute for Health Research Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Claudius H', 'Initials': 'CH', 'LastName': 'Reisse', 'Affiliation': 'Oslo University Hospital, The Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Paton', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Steel', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Narelle C', 'Initials': 'NC', 'LastName': 'Williams', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Scolyer', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Morton', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Thompson', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01414']
1298,31050809,Characterizing red blood cell age exposure in massive transfusion therapy: the scalar age of blood index (SBI).,"BACKGROUND
The mortality of trauma patients requiring massive transfusion to treat hemorrhagic shock approaches 17% at 24 hours and 26% at 30 days. The use of stored RBCs is limited to less than 42 days, so older RBCs are delivered first to rapidly bleeding trauma patients. Patients who receive a greater quantity of older RBCs may have a higher risk for mortality.
METHODS AND MATERIALS
Characterizing blood age exposure requires accounting for the age of each RBC unit and the quantity of transfused units. To address this challenge, a novel Scalar Age of Blood Index (SBI) that represents the relative distribution of RBCs received is introduced and applied to a secondary analysis of the Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) randomized controlled trial (NCT01545232, https://clinicaltrials.gov/ct2/show/NCT01545232). The effect of the SBI is assessed on the primary PROPPR outcome, 24-hour and 30-day mortality.
RESULTS
The distributions of blood storage ages successfully maps to a parameter (SBI) that fully defines the blood age curve for each patient. SBI was a significant predictor of 24-hour and 30-day mortality in an adjusted model that had strong predictive ability (odds ratio, 1.15 [1.01-1.29], p = 0.029, C-statistic, 0.81; odds ratio, 1.14 [1.02-1.28], p = 0.019, C-statistic, 0.88, respectively).
CONCLUSION
SBI is a simple scalar metric of blood age that accounts for the relative distribution of RBCs among age categories. Transfusion of older RBCs is associated with 24-hour and 30-day mortality, after adjustment for total units and clinical covariates.",2019,"Transfusion of older RBCs is associated with 24-hour and 30-day mortality, after adjustment for total units and clinical covariates.",['trauma patients requiring massive transfusion'],"['SBI', 'stored RBCs']","['Blood Index', '24-hour and 30-day mortality', 'blood index (SBI', 'primary PROPPR outcome, 24-hour and 30-day mortality']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]",[],"[{'cui': 'C0005768'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",,0.092142,"Transfusion of older RBCs is associated with 24-hour and 30-day mortality, after adjustment for total units and clinical covariates.","[{'ForeName': 'Stacia M', 'Initials': 'SM', 'LastName': 'DeSantis', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Jones', 'Affiliation': 'Department of Acute, Chronic and Continuing Care, School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jose-Miguel', 'Initials': 'JM', 'LastName': 'Yamal', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Pittet', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rakesh P', 'Initials': 'RP', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': 'Department of Surgery, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Department of Surgery, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15334']
1299,30846896,"New Crosslinked Hyaluronan Gel, Intrauterine Device, or Both for the Prevention of Intrauterine Adhesions.","Background and Objectives
To compare the efficacy of 3 different techniques for prevention of adhesion reformation after hysteroscopic adhesiolysis in patients with moderate-to-severe intrauterine adhesions. Short-term assisted reproductive outcomes were also compared.
Study Design
Total of 72 cases were randomized to Lippes loop intrauterine device (IUD) only, IUD plus a new crosslinked hyaluronan (NCH) gel, or NCH gel only following hysteroscopic adhesiolysis. All cases received hormonal therapy and a second hysteroscopy was carried out. Endometrial thickness values were measured using transvaginal ultrasonography and American Fertility Society adhesion scores were noted during first and second hysteroscopy in all groups. Reproductive outcomes were also compared for those who received in vitro fertilization treatment.
Results
Transvaginal ultrasonography revealed significantly better endometrial thickness in the IUD+NCH (7.5 mm) and NCH-only groups (6.5 mm) than the IUD-only group (5 mm) ( P < .001). All groups revealed enhanced but comparable American Fertility Society adhesion scores on second-look hysteroscopy. A total of 37 patients received in vitro fertilization treatment after surgical management of adhesions. Ongoing pregnancy rates after in vitro fertilization were 27%, 40%, and 36% in IUD, IUD+NCH, and NCH groups, respectively. However, the difference between the groups did not reach statistically significant difference.
Conclusion
All interventions are of similar efficacy in the prevention of adhesion reformation after hysteroscopic adhesiolysis for moderate to severe intrauterine adhesions. However, better endometrial thickness values were observed in those who received NCH gel either alone or in combination with IUD. Assisted reproductive outcomes of both groups were comparable for ongoing pregnancy rates.",2019,"Ongoing pregnancy rates after in vitro fertilization were 27%, 40%, and 36% in IUD, IUD+NCH, and NCH groups, respectively.","['patients with moderate-to-severe intrauterine adhesions', '37 patients received in', 'Study Design\n\n\nTotal of 72 cases']","['Transvaginal ultrasonography', 'NCH gel either alone or in combination with IUD', 'vitro fertilization treatment', 'IUD+NCH', 'Lippes loop intrauterine device (IUD) only, IUD plus a new crosslinked hyaluronan (NCH) gel, or NCH gel', 'hormonal therapy and a second hysteroscopy']","['transvaginal ultrasonography and American Fertility Society adhesion scores', 'endometrial thickness values', 'American Fertility Society adhesion scores', 'Endometrial thickness values', 'endometrial thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1704274', 'cui_str': 'Intrauterine adhesions (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0813622', 'cui_str': 'Hyaluronan'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",72.0,0.175728,"Ongoing pregnancy rates after in vitro fertilization were 27%, 40%, and 36% in IUD, IUD+NCH, and NCH groups, respectively.","[{'ForeName': 'Emre G', 'Initials': 'EG', 'LastName': 'Pabuçcu', 'Affiliation': 'Department of Obstetrics and Gynecology, Ufuk University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ertuğ', 'Initials': 'E', 'LastName': 'Kovanci', 'Affiliation': 'Aspire Fertility, Houston, TX, USA.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Şahin', 'Affiliation': 'Department of Obstetrics and Gynecology, Ufuk University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Arslanoğlu', 'Affiliation': 'Department of Biostatistics, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Yiğit', 'Initials': 'Y', 'LastName': 'Yıldız', 'Affiliation': 'Department of Obstetrics and Gynecology, Ufuk University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Recai', 'Initials': 'R', 'LastName': 'Pabuçcu', 'Affiliation': 'Department of Obstetrics and Gynecology, Ufuk University School of Medicine, Ankara, Turkey.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2018.00108']
1300,31042551,Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined HF Population: The GENETIC-AF Trial.,"OBJECTIVES
The purpose of this study was to compare the effectiveness of bucindolol with that of metoprolol succinate for the maintenance of sinus rhythm in a genetically defined heart failure (HF) population with atrial fibrillation (AF).
BACKGROUND
Bucindolol is a beta-blocker whose unique pharmacologic properties provide greater benefit in HF patients with reduced ejection fraction (HFrEF) who have the beta 1 -adrenergic receptor (ADRB1) Arg389Arg genotype.
METHODS
A total of 267 HFrEF patients with a left ventricular ejection fraction (LVEF) <0.50, symptomatic AF, and the ADRB1 Arg389Arg genotype were randomized 1:1 to receive bucindolol or metoprolol therapy and were up-titrated to target doses. The primary endpoint of AF or atrial flutter (AFL) or all-cause mortality (ACM) was evaluated by electrocardiogram (ECG) during a 24-week period.
RESULTS
The hazard ratio (HR) for the primary endpoint was 1.01 (95% confidence interval [CI]: 0.71 to 1.42), but trends for bucindolol benefit were observed in several subgroups. Precision therapeutic phenotyping revealed that a differential response to bucindolol was associated with the interval of time from the initial diagnoses of AF and HF to randomization and with the onset of AF relative to that of the initial HF diagnosis. In a cohort whose first AF and HF diagnoses were <12 years prior to randomization, in which AF onset did not precede HF by more than 2 years (n = 196), the HR was 0.54 (95% CI: 0.33 to 0.87; p = 0.011).
CONCLUSIONS
Pharmacogenetically guided bucindolol therapy did not reduce the recurrence of AF/AFL or ACM compared to that of metoprolol therapy in HFrEF patients, but populations were identified who merited further investigation in future phase 3 trials.",2019,"CONCLUSIONS
Pharmacogenetically guided bucindolol therapy did not reduce the recurrence of AF/AFL or ACM compared to that of metoprolol therapy in HFrEF patients, but populations were identified who merited further investigation in future phase 3 trials.","['sinus rhythm in a genetically defined heart failure (HF) population with atrial fibrillation (AF', 'HF patients with reduced ejection fraction (HFrEF) who have the beta 1 -adrenergic receptor (ADRB1', '267 HFrEF patients with a left ventricular ejection fraction (LVEF)\xa0<0.50, symptomatic AF, and the ADRB1']","['bucindolol', 'metoprolol succinate', 'Bucindolol', 'metoprolol', 'bucindolol or metoprolol therapy']","['bucindolol benefit', 'recurrence of AF/AFL or ACM', 'hazard ratio (HR', 'AF or atrial flutter (AFL) or all-cause mortality (ACM']","[{'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0001642', 'cui_str': 'Receptors, Adrenergic, beta-1'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0054196', 'cui_str': 'bucindolol'}, {'cui': 'C0724633', 'cui_str': 'metoprolol succinate'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0054196', 'cui_str': 'bucindolol'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",267.0,0.0335906,"CONCLUSIONS
Pharmacogenetically guided bucindolol therapy did not reduce the recurrence of AF/AFL or ACM compared to that of metoprolol therapy in HFrEF patients, but populations were identified who merited further investigation in future phase 3 trials.","[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina. Electronic address: jonathan.piccini@duke.edu.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Ohio State University Medical Center, Columbus, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dufton', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Carroll', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Sauer', 'Affiliation': 'University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'U.S. Department of Veterans Affairs, Washington, DC.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Wilton', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Aleong', 'Affiliation': 'University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rienstra', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Krueger', 'Affiliation': 'Bryan Heart Institute, Columbus, Nebraska.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ayala-Paredes', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Yaariv', 'Initials': 'Y', 'LastName': 'Khaykin', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Ontario, Canada.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center of the Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Miloradović', 'Affiliation': 'University of Kragujevac and Clinical Center Kragujevac, Kragujevac, Serbia.'}, {'ForeName': 'Jerzy K', 'Initials': 'JK', 'LastName': 'Wranicz', 'Affiliation': 'Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Ilkhanoff', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Ziegler', 'Affiliation': 'Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Emery', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Marshall', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kao', 'Affiliation': 'University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Bristow', 'Affiliation': 'ARCA Biopharma, Inc., Westminster, Colorado; University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2019.04.004']
1301,31838486,"Impact of Cervical Sensory Feedback for Forward Head Posture on Headache Severity and Physiological Factors in Patients with Tension-type Headache: A Randomized, Single-Blind, Controlled Trial.","BACKGROUND Tension-type headache (TTH) decreases the ability to concentrate and function during daily activities in affected patients. As most patients with TTH exhibit forward head posture (FHP). Various interventions have been proposed to resolve TTH. However, research regarding the efficacy of these interventions remains lacking. The present study aimed to investigate the association between FHP and TTH, and to evaluate the efficacy of various intervention methods on headache symptoms and other clinical variables in patients with TTH induced by FHP. MATERIAL AND METHODS Participants were randomly allocated to 3 groups: biofeedback (BF, n₁=21), manual therapy (MT, n₂=20) and, stretching (ST, n₃=21). Interventions were conducted 3 times per week for 4 weeks. Craniovertebral angle (CVA), electroencephalographic findings for attention, stress, and pressure-pain threshold (PPT), headache on activities of daily living (Henry Ford Headache Disability Inventory, HDI), and quality of life (QoL) assessments were obtained pre-intervention, post-intervention, and at the 2-week follow-up. RESULTS The correlation between CVA and HDI after intervention (R²=0.324, P<0.001), and at 2-week follow-up (R²=0.115, P<0.01) are significant. BF was associated with significant improvements in CVA (F₂,₅₉=3.393, P<0.001, η^2/P=0.130), attention (F₂,₅₉=5.186, P<0.01, η^2/P=0.150), stress [skin temperature (F₂,₅₉=6.005, P<0.001, η^2/P=0.169) and skin conductance (F₂,₅₉=4.900, P<0.01, η^2/P=0.142)], PPT (F₂,₅₉=5.050, P<0.01, η^2/P=0.146), HDI (F₂,₅₉=3.303, P<0.01, η^2/P=0.101), and QoL (F₂,₅₉=3.409, P<0.05, η^2/P=0.104). CONCLUSIONS Our findings indicate that BF was more effective than MT and ST in the treatment of TTH due to FHP. Such findings highlight the need to develop and promote a controlled exercise program to facilitate a return to normal daily activities in patients with TTH due to FHP.",2019,"BF was associated with significant improvements in CVA (F₂,₅₉=3.393, P<0.001, η^2/P=0.130), attention (F₂,₅₉=5.186, P<0.01, η^2/P=0.150), stress [skin temperature (F₂,₅₉=6.005, P<0.001, η^2/P=0.169) and skin conductance (F₂,₅₉=4.900, P<0.01, η^2/P=0.142)], PPT (F₂,₅₉=5.050, P<0.01, η^2/P=0.146), HDI (F₂,₅₉=3.303, P<0.01, η^2/P=0.101), and QoL (F₂,₅₉=3.409, P<0.05, η^2/P=0.104).","['Patients with Tension-type Headache', 'patients with TTH due to FHP', 'patients with TTH induced by FHP', 'patients with TTH exhibit forward head posture (FHP']","['Cervical Sensory Feedback for Forward Head Posture', 'biofeedback (BF, n₁=21), manual therapy (MT, n₂=20) and, stretching (ST, n₃=21']","['Headache Severity and Physiological Factors', 'skin conductance', 'headache symptoms', 'stress [skin temperature', 'CVA and HDI', 'Craniovertebral angle (CVA), electroencephalographic findings for attention, stress, and pressure-pain threshold (PPT), headache on activities of daily living (Henry Ford Headache Disability Inventory, HDI), and quality of life (QoL) assessments', 'CVA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033893', 'cui_str': 'Tension-Type Headache'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1262869', 'cui_str': 'Posture'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0178842', 'cui_str': 'Sensory Feedback'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0582517', 'cui_str': 'henry (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0336232,"BF was associated with significant improvements in CVA (F₂,₅₉=3.393, P<0.001, η^2/P=0.130), attention (F₂,₅₉=5.186, P<0.01, η^2/P=0.150), stress [skin temperature (F₂,₅₉=6.005, P<0.001, η^2/P=0.169) and skin conductance (F₂,₅₉=4.900, P<0.01, η^2/P=0.142)], PPT (F₂,₅₉=5.050, P<0.01, η^2/P=0.146), HDI (F₂,₅₉=3.303, P<0.01, η^2/P=0.101), and QoL (F₂,₅₉=3.409, P<0.05, η^2/P=0.104).","[{'ForeName': 'Eunsang', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, The Graduate School of Sahmyook University, Seoul, South Korea.'}, {'ForeName': 'Seungwon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Health and Welfare, Sahmyook University, Seoul, South Korea.'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.918595']
1302,30422094,"The effect of a care program and social support on anxiety level in mothers of late preterm infants in Sistan and Baluchestan, Iran.","Late and moderate preterm (LAMP) neonates are at risk of developing severe complications that can lead to anxiety in mothers. The aim of this study was to determine the effectiveness of a care program on the anxiety level of mothers with LAMP babies and to determine the effectiveness of the care program on the level of anxiety of new mothers in the presence of social support. This quasi-experimental study was conducted on 80 mothers whose late preterm infants were admitted to neonatal intensive care unit at Ali-ibn Abi Talib Hospital, Zahedan. Data were gathered between July 10 and October 13, 2016. The intervention group received the care program. Anxiety and social support were evaluated using the State-Trait Anxiety Inventory and Multidimensional Scale of Perceived Social Support (MSPSS), respectively. After receiving the intervention, the mean MSPSS was higher for the mothers in the intervention group (p = .0025). Additionally, they experienced less state anxiety 72 hours after discharge and 1 month after delivery (p < .0025). Regression analysis showed that mothers with higher social support were 39 percent more likely to be in the ""no to moderate STAI"" (<51) group. Perceived social support can mediate the effect of care programs on diminishing anxiety.",2019,"After receiving the intervention, the mean MSPSS was higher for the mothers in the intervention group (p = .0025).","['80 mothers whose late preterm infants were admitted to neonatal intensive care unit at Ali-ibn Abi Talib Hospital, Zahedan', 'mothers with LAMP babies', 'mothers of late preterm infants in Sistan and Baluchestan, Iran']","['care program and social support', 'care program']","['mean MSPSS', 'State-Trait Anxiety Inventory and Multidimensional Scale of Perceived Social Support (MSPSS', 'Anxiety and social support', 'state anxiety', 'anxiety level']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0037438'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C0037438'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",,0.0318279,"After receiving the intervention, the mean MSPSS was higher for the mothers in the intervention group (p = .0025).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moudi', 'Affiliation': 'a Pregnancy Health Research Center , Zahedan University of Medical Sciences , Zahedan , Iran.'}, {'ForeName': 'Batoul', 'Initials': 'B', 'LastName': 'Molashahi', 'Affiliation': 'a Pregnancy Health Research Center , Zahedan University of Medical Sciences , Zahedan , Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ansari', 'Affiliation': 'd Dept of Epidemiology & Biostatistics, School of Health , Zahedan University of Medical Sciences , Zahedan , Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Imani', 'Affiliation': 'c Dept of Pediatrics , Zahedan University of Medical Science , Zahedan , Iran.'}]",Women & health,['10.1080/03630242.2018.1508540']
1303,31031050,The Impact of Design and Performance in Prostate-Specific Antigen Screening: Differences Between ERSPC Centers.,"The European Randomized study of Screening for Prostate Cancer (ERSPC) has shown a 20% relative reduction in prostate cancer mortality after 16yr [rate ratio (RR) 0.80], but centers varied by attendance, screen interval, biopsy compliance, contamination in the control arm, and treatments. We used a microsimulation model, calibrated to the ERSPC individual-level data, to predict influence of study features on the results. The relative reduction in prostate cancer mortality would have been somewhat larger with improved study features: increased attendance (90% attendance in all volunteer-based and 70% in all population-based centers, resulting in RR 0.77), a 2-yr screen interval (RR 0.75), and an 80% biopsy compliance (RR 0.79). The RR would have been substantially lower with a 30% attendance (RR 0.92), 40% biopsy compliance (RR 0.90), or 100% contamination (RR 0.85). The variations in results by trial center may reflect differences in study design and performance and results of our simulations highlight the effect of quality indicators in prostate-specific antigen screening in different settings. PATIENT SUMMARY: We evaluated the effect of various features of prostate-specific antigen (PSA) screening on its effectiveness. The compliance to PSA testing and those having a biopsy after an elevated PSA substantially influence the prostate cancer mortality.",2019,"The European Randomized study of Screening for Prostate Cancer (ERSPC) has shown a 20% relative reduction in prostate cancer mortality after 16yr [rate ratio (RR) 0.80], but centers varied by attendance, screen interval, biopsy compliance, contamination in the control arm, and treatments.",[],['prostate-specific antigen (PSA) screening'],"['attendance', 'prostate cancer mortality']",[],"[{'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.131505,"The European Randomized study of Screening for Prostate Cancer (ERSPC) has shown a 20% relative reduction in prostate cancer mortality after 16yr [rate ratio (RR) 0.80], but centers varied by attendance, screen interval, biopsy compliance, contamination in the control arm, and treatments.","[{'ForeName': 'Eveline A M', 'Initials': 'EAM', 'LastName': 'Heijnsdijk', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. Electronic address: e.heijnsdijk@erasmusmc.nl.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Adolfsson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'School of Health Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Department of Urology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",European urology,['10.1016/j.eururo.2019.04.007']
1304,31036468,"Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND
Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. In an exploratory study, the combination of tucidinostat with exemestane showed preliminary signs of encouraging anti-tumour activity in patients with advanced hormone receptor-positive breast cancer. To build on these findings, we aimed to assess the efficacy and safety of this combination in a randomised trial in a larger population of postmenopausal patients with advanced, hormone receptor-positive breast cancer.
METHODS
We did the randomised, double-blind, placebo-controlled, phase 3 ACE trial at 22 specialist cancer centres in China. Eligible patients were postmenopausal women (aged ≥60 years or aged <60 years if their serum follicle-stimulating hormone and oestradiol concentrations were within postmenopausal ranges) with hormone receptor-positive, HER2-negative breast cancer, whose disease had relapsed or progressed after at least one endocrine therapy (either in advanced or metastatic or adjuvant setting), and who had at least one measurable lesion, adequate organ function, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate haematological and biochemical parameters. Endocrine therapy did not have to be the most recent therapy before randomisation, but recurrence or progression after the most recent therapy was a prerequisite. Patients were randomly assigned (2:1) by a dynamic randomisation scheme via an interactive web-response system to receive 30 mg oral tucidinostat or placebo twice weekly. All patients in both groups also received 25 mg oral exemestane daily. Randomisation was stratified according to the presence of visceral metastases (yes vs no). Patients, investigators, study site staff, and the sponsor were masked to treatment assignment. The primary endpoint was investigator-assessed progression-free survival. Efficacy analyses were done in the full analysis set population, comprising all patients who received at least one dose of any study treatment, and safety analyses were done in all patients who received at least one dose of any study treatment and for whom at least one safety case report form was available. This study is registered with ClinicalTrials.gov, number NCT02482753. The study has reached the required number of events for final analysis of the primary endpoint. The trial is no longer enrolling patients, but follow-up for investigation of overall survival is ongoing.
FINDINGS
Between July 20, 2015, and June 26, 2017, 365 patients were enrolled and randomly assigned, 244 to the tucidinostat group and 121 to the placebo group. The median duration of follow-up was 13·9 months (IQR 9·8-17·5). Investigator-assessed median progression-free survival was 7·4 months (95% CI 5·5-9·2) in the tucidinostat group and 3·8 months (3·7-5·5) in the placebo group (HR 0·75 [95% CI 0·58-0·98]; p=0·033). The most common grade 3 or 4 adverse events in either group were neutropenia (124 [51%] of 244 patients in the tucidinostat group vs three [2%] of 121 patients in the placebo group), thrombocytopenia (67 [27%] vs three [2%]), and leucopenia (46 [19%] vs three [2%]). Serious adverse events of any cause occurred in 51 (21%) of 244 patients in the tucidinostat group and seven (6%) of 121 patients in the placebo group. No treatment-related deaths were reported.
INTERPRETATION
Tucidinostat plus exemestane improved progression-free survival compared with placebo plus exemestane in patients with advanced, hormone receptor-positive, HER2-negative breast cancer that progressed after previous endocrine therapy. Grade 3-4 haematological adverse events were more common in the tucidinostat plus exemestane group than in the placebo plus exemestane group. Tucidinostat plus exemestane could represent a new treatment option for these patients.
FUNDING
Chipscreen Biosciences.",2019,Grade 3-4 haematological adverse events were more common in the tucidinostat plus exemestane group than in the placebo plus exemestane group.,"['Eligible patients were postmenopausal women (aged ≥60 years or aged <60 years if their serum follicle-stimulating hormone and oestradiol concentrations were within postmenopausal ranges) with hormone receptor-positive, HER2-negative breast cancer, whose disease had relapsed or progressed after at least one endocrine therapy (either in advanced or metastatic or adjuvant setting), and who had at least one measurable lesion, adequate organ function, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate haematological and biochemical parameters', '22 specialist cancer centres in China', 'Between July 20, 2015, and June 26, 2017, 365 patients were enrolled and randomly assigned, 244 to the tucidinostat group and 121 to the', 'postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE', 'postmenopausal patients with advanced, hormone receptor-positive breast cancer', 'patients with advanced, hormone receptor-positive, HER2-negative breast cancer that progressed after previous endocrine therapy', 'patients with advanced hormone receptor-positive breast cancer']","['Tucidinostat plus exemestane', 'placebo plus exemestane', 'placebo', 'Endocrine therapy', 'oral exemestane', 'exemestane', 'dynamic randomisation scheme via an interactive web-response system to receive 30 mg oral tucidinostat or placebo']","['median duration', 'Investigator-assessed median progression-free survival', 'progression-free survival', 'Grade 3-4 haematological adverse events', 'neutropenia', 'efficacy and safety', 'leucopenia', 'investigator-assessed progression-free survival', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",22.0,0.664732,Grade 3-4 haematological adverse events were more common in the tucidinostat plus exemestane group than in the placebo plus exemestane group.,"[{'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'The Fifth Medical Centre of Chinese PLA General Hospital, Beijing, China. Electronic address: jiangzefei@csco.org.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Liaoning Cancer Hospital & Institute, Shenyang, China.'}, {'ForeName': 'Shude', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sun Yat-Sen University Cancer Centre, Guangzhou, China.'}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Cuizhi', 'Initials': 'C', 'LastName': 'Geng', 'Affiliation': 'Tumour Hospital of Hebei Province, Shijiazhuang, China.'}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Yueyin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Third Hospital of Nanchang, Nanchang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Ouyang', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Kangsheng', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': 'The First Affiliated Hospital of Anui Medical University, Hefei, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Beijing University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Fudan University Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Ning', 'Affiliation': 'Chipscreen Biosciences, Shenzhen, China.'}, {'ForeName': 'Xianping', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Chipscreen Biosciences, Shenzhen, China.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30164-0']
1305,30896062,Endocuff Vision-assisted colonoscopy: a randomized controlled trial.,"BACKGROUND
Adenoma detection rate (ADR) has shown to be an independent predictor, to reduce the rate of interval colorectal cancer. Endocuff Vision is a relatively new device that has shown promise to improve the ADR. The primary objective was to conduct a randomized controlled trial to compare Endocuff Vision-assisted colonoscopy (EVAC) with standard colonoscopy (SC). The primary outcome of the study is ADR and the secondary outcomes are caecal intubation rate, terminal ileum intubation rate, scope withdrawal time, quality of bowel preparation and adverse events.
METHODS
A randomized controlled trial was performed to compare EVAC versus SC. All patients who presented to the endoscopy suite at the Queen Elizabeth Hospital were assessed for eligibility. Patients were recruited from 15 June 2016 to 20 January 2017. A total of 360 patients were included; 40 were excluded. The patients were randomized using block randomization; 138 patients were recruited to SC and 182 to EVAC.
RESULTS
A total of 231 polyps were retrieved during the study period. Polyp detection rate (PDR) was high in both groups: 53% in the EVAC group versus 41.1% in SC. This was statistically significant with a P-value of 0.035. ADR was similarly high in both groups: 36.81% in EVAC group versus 28.99% in SC group. ADR did not reach statistical significance.
CONCLUSIONS
EVAC does improve the PDR. Though the ADR did not reach statistical significance, there is a trend towards improved adenoma detection and there is statistical significance in the overall PDR.",2019,Polyp detection rate (PDR) was high in both groups: 53% in the EVAC group versus 41.1% in SC.,"['All patients who presented to the endoscopy suite at the Queen Elizabeth Hospital were assessed for eligibility', 'A total of 231 polyps', '138 patients were recruited to SC and 182 to EVAC', 'Patients were recruited from 15 June 2016 to 20 January 2017', 'A total of 360 patients were included; 40 were excluded']","['EVAC', 'Endocuff Vision-assisted colonoscopy (EVAC) with standard colonoscopy (SC', 'Endocuff Vision-assisted colonoscopy', 'EVAC versus SC']","['ADR', 'PDR', 'rate of interval colorectal cancer', 'caecal intubation rate, terminal ileum intubation rate, scope withdrawal time, quality of bowel preparation and adverse events', 'Polyp detection rate (PDR', 'adenoma detection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0227327', 'cui_str': 'Structure of distal portion of ileum'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",360.0,0.298956,Polyp detection rate (PDR) was high in both groups: 53% in the EVAC group versus 41.1% in SC.,"[{'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Jacob', 'Affiliation': 'Colorectal Surgical Unit, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schafer', 'Affiliation': 'Colorectal Surgical Unit, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Yong', 'Affiliation': 'Colorectal Surgical Unit, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Tonkin', 'Affiliation': 'Colorectal Surgical Unit, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodda', 'Affiliation': 'Colorectal Surgical Unit, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Eteuati', 'Affiliation': 'Colorectal Surgical Unit, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Shanthan', 'Initials': 'S', 'LastName': 'Ganesh', 'Affiliation': 'Colorectal Surgical Unit, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hewett', 'Affiliation': 'Colorectal Surgical Unit, The University of Adelaide, Adelaide, South Australia, Australia.'}]",ANZ journal of surgery,['10.1111/ans.15067']
1306,32407327,How much is enough? Exploring the dose-response relationship between cash transfers and surgical utilization in a resource-poor setting.,"OBJECTIVE
Cash transfers are a common intervention to incentivize salutary behavior in resource-constrained settings. Many cash transfer studies do not, however, account for the effect of the size of the cash transfer in design or analysis. A randomized, controlled trial of a cash-transfer intervention is planned to incentivize appropriate surgical utilization in Guinea. The aim of the current study is to determine the size of that cash transfer so as to maximize compliance while minimizing cost.
METHODS
Data were collected from nine coastal Guinean hospitals on their surgical capabilities and the cost of receiving surgery. These data were combined with publicly available data about the general Guinean population to create an agent-based model predicting surgical utilization. The model was validated to the available literature on surgical utilization. Cash transfer sizes from 0 to 1,000,000 Guinean francs were evaluated, with surgical compliance as the primary outcome.
RESULTS
Compliance with scheduled surgery increases as the size of a cash transfer increases. This increase is asymptotic, with a leveling in utilization occurring when the cash transfer pays for all the costs associated with surgical care. Below that cash transfer size, no other optima are found. Once a cash transfer completely covers the costs of surgery, other barriers to care such as distance and hospital quality dominate.
CONCLUSION
Cash transfers to incentivize health-promoting behavior appear to be dose-dependent. Maximal impact is likely only to occur when full patient costs are eliminated. These findings should be incorporated in the design of future cash transfer studies.",2020,"This increase is asymptotic, with a leveling in utilization occurring when the cash transfer pays for all the costs associated with surgical care.","['Data were collected from nine coastal Guinean hospitals on their surgical capabilities and the cost of receiving surgery', 'Guinea']",['cash-transfer intervention'],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018381', 'cui_str': 'Guinea Republic'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0274983,"This increase is asymptotic, with a leveling in utilization occurring when the cash transfer pays for all the costs associated with surgical care.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Strader', 'Affiliation': 'Program in Global Surgery and Social Change, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Ashby', 'Affiliation': 'Program in Global Surgery and Social Change, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Vervoort', 'Affiliation': 'Program in Global Surgery and Social Change, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Aref', 'Initials': 'A', 'LastName': 'Ebrahimi', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Shoghi', 'Initials': 'S', 'LastName': 'Agbortoko', 'Affiliation': 'Harvard College, Cambridge, MA, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Harvard College, Cambridge, MA, United States of America.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Reiner', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, MA, United States of America.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Zeme', 'Affiliation': 'Harvard College, Cambridge, MA, United States of America.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Shrime', 'Affiliation': 'Program in Global Surgery and Social Change, Harvard Medical School, Boston, MA, United States of America.'}]",PloS one,['10.1371/journal.pone.0232761']
1307,30794143,Increasing Mobility via In-hospital Ambulation Protocol Delivered by Mobility Technicians: A Pilot Randomized Controlled Trial.,"BACKGROUND
Ambulating medical inpatients may improve outcomes, but this practice is often overlooked by nurses who have competing clinical duties.
OBJECTIVE
This study aimed to assess the feasibility and effectiveness of dedicated mobility technician-assisted ambulation in older inpatients.
DESIGN
This study was a single-blind randomized controlled trial.
SETTING
Patients aged ≥60 years and admitted as medical inpatients to a tertiary care center were recruited.
INTERVENTION
Patients were randomized into two groups to participate in the ambulation protocol administered by a dedicated mobility technician. Usual care patients were not seen by the mobility technician but were not otherwise restricted in their opportunity to ambulate.
MEASUREMENTS
Primary outcomes were length of stay and discharge disposition. Secondary outcomes included change in mobility measured by six-clicks score, daily steps measured by Fitbit, and 30-day readmission.
RESULTS
Control (n = 52) and intervention (n = 50) groups were not significantly different at baseline. Of patients randomized to the intervention group, 74% participated at least once. Although the intervention did not affect the primary outcomes, the intervention group took nearly 50% more steps than the control group (P = .04). In the per protocol analysis, the six-clicks score significantly increased (P = .04). Patients achieving ≥400 steps were more likely to go home (71% vs 46%, P = .01).
CONCLUSIONS
Attempted ambulation three times daily overseen by a dedicated mobility technician was feasible and increased the number of steps taken. A threshold of 400 steps was predictive of home discharge. Further studies are needed to establish the appropriate step goal and the effect of assisted ambulation on hospital outcomes.",2019,"Patients achieving ≥400 steps were more likely to go home (71% vs 46%, P = .01).
","['Control (n = 52) and intervention (n = 50', 'Ambulating medical inpatients', 'Patients aged ≥60 years and admitted as medical inpatients to a tertiary care center were recruited', 'older inpatients']","['dedicated mobility technician-assisted ambulation', 'ambulation protocol administered by a dedicated mobility technician']","['number of steps taken', 'six-clicks score', 'feasibility and effectiveness', 'length of stay and discharge disposition', 'change in mobility measured by six-clicks score, daily steps measured by Fitbit, and 30-day readmission']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",,0.128599,"Patients achieving ≥400 steps were more likely to go home (71% vs 46%, P = .01).
","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Hamilton', 'Affiliation': 'Department of Hospital Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stilphen', 'Affiliation': 'Rehabilitation and Sports Therapy, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schramm', 'Affiliation': 'Center for Value-Based Care Research, Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Frost', 'Affiliation': 'Physical Medicine and Rehabilitation, Cleveland Clinic, Cleve-land, Ohio.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': 'Center for Value-Based Care Research, Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Rothberg', 'Affiliation': 'Center for Value-Based Care Research, Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}]",Journal of hospital medicine,['10.12788/jhm.3153']
1308,31642928,Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial.,"Importance
Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations.
Objective
To investigate whether internet-delivered cognitive behavior therapy implemented within a stepped care model is noninferior to, and cost-effective compared with, the gold standard of face-to-face cognitive behavior therapy for pediatric obsessive-compulsive disorder.
Design, Setting, and Participants
Multicenter, single-blind, randomized clinical noninferiority trial implemented at 2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden. Participants are 152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral. Patients will be randomized 1:1 to the stepped care intervention or face-to-face therapy. Blind evaluations will be conducted after treatment and at 3-month and 6-month follow-ups. At the 6-month follow-up (primary end point), noninferiority will be tested and resource use will be compared between the 2 treatment groups. Data will be analyzed according to intention-to-treat principles.
Intervention
Patients randomized to stepped care will first receive internet-delivered cognitive behavior therapy for 16 weeks; patients who are classified as nonresponders 3 months after treatment completion will receive additional face-to-face therapy. The control group will receive 16 weeks of face-to-face cognitive behavior therapy immediately following randomization and nonresponders at the 3-month follow-up will, as in the stepped care group, receive additional face-to-face therapy.
Main Outcomes and Measures
Noninferiority is defined as a 4-point difference on the primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale).
Discussion
Recruitment started October 6, 2017, and was completed May 24, 2019. Results from the primary end point will be available by May 2020. The naturalistic follow-ups (1, 2, and 5 years after the end of treatment) will continue to 2025. There are no interim analyses planned or stopping rules for the trial.
Trial Registration
ClinicalTrials.gov identifier: NCT03263546.",2019,"Importance
Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations.
","['pediatric obsessive-compulsive disorder', '2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden', 'Pediatric Obsessive-Compulsive Disorder', '152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral', 'children and adolescents with obsessive-compulsive disorder']","['stepped care intervention or face-to-face therapy', 'stepped care will first receive internet-delivered cognitive behavior therapy', 'stepped care group, receive additional face-to-face therapy', 'Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy', 'internet-delivered cognitive behavior therapy', 'Importance\n\n\nInternet-delivered cognitive behavior therapy', 'gold standard of face-to-face cognitive behavior therapy']","[""primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale""]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237824', 'cui_str': 'Self-referral (procedure)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}]",152.0,0.0981064,"Importance
Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations.
","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Aspvall', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Lenhard', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Melin', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Norlin', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Child and Adolescent Psychiatry Specialized Unit, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Wallin', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Silverberg-Mörse', 'Affiliation': 'Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Feldman', 'Affiliation': ""Department of Women's and Children's Health, Uppsala Universitet, Uppsala, Sweden.""}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Institute of Environmental Medicine, Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Serlachius', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.13810']
1309,31642929,Association of a Multimodal Educational Intervention for Primary Care Physicians With Prescriptions of Buprenorphine for Opioid Use Disorders.,"Importance
Opioid use disorder (OUD) is a public health crisis in the United States, but only 5% of US physicians have obtained a Drug Addiction Treatment Act (DATA) waiver to prescribe buprenorphine to treat OUD. Increasing the number of primary care physicians (PCPs) who have obtained the waiver and are able to treat patients with OUD is of utmost importance.
Objective
To determine whether a multimodal educational intervention of PCPs is associated with an increase in the number of buprenorphine waivers obtained and patients initiated into treatment in a primary care setting.
Design, Setting, and Participants
This quality improvement study was conducted in primary health care clinics within a large, integrated health care system. Patients included those who had received a diagnosis of OUD, and had Providence Health Plan Medicare or Medicaid insurance. Included PCPs were divided into 2 groups: those who obtained a DATA waiver after an education intervention (uptake PCPs) vs those who did not obtain a DATA waiver (nonuptake PCPs). The study took place between January 1, 2016, and December 31, 2017. Data analyses were conducted from December 2017 to August 2019.
Exposures
Multimodal educational intervention including video, in-person visits to clinical practitioner meetings by physician champions, and a primary care toolkit with training resources and clinic protocols.
Main Outcomes and Measures
The number of new uptake clinics where at least 1 PCP obtained a DATA waiver, the number of new PCPs with DATA waivers, the number of patients receiving a buprenorphine prescription, and the number of patients who received 12 or more weeks of treatment.
Results
Twenty-seven of 41 invited clinics implemented the intervention, and 620 PCPs were included. The number of PCPs with DATA waivers increased from 5 PCPs (0.8%) to 44 PCPs (7.1%), and the number of clinics with at least 1 buprenorphine prescriber increased from 3 clinics (7.3%) to 17 clinics (41.5%). In total, 213 patients underwent buprenorphine treatment, and 140 patients received 12 or more weeks of treatment. A total of 646 patients had Providence Health Plan Medicare or Medicaid insurance and were eligible for the study (mean [SD] age, 61.7 [16.5] years; 410 [63.5%] women). There was a statistically significant difference in treatment with buprenorphine between patients with uptake PCPs vs patients with nonuptake PCPs (23 patients [16.4%] vs 18 patients [3.5%]; odds ratio, 4.61 [95% CI, 2.32-10.51]; P = .01) after the intervention.
Conclusions and Relevance
In this quality improvement study, an educational intervention was associated with an increase in the number of PCPs and clinics that could provide buprenorphine treatment for OUD and with an increase in the patients who were able to access care with medications for OUD.",2019,"To determine whether a multimodal educational intervention of PCPs is associated with an increase in the number of buprenorphine waivers obtained and patients initiated into treatment in a primary care setting.
","['Primary Care Physicians With Prescriptions of Buprenorphine for Opioid Use Disorders', 'Twenty-seven of 41 invited clinics implemented the intervention, and 620 PCPs were included', '646 patients had Providence Health Plan Medicare or Medicaid insurance and were eligible for the study (mean [SD] age, 61.7 [16.5] years; 410 [63.5%] women', '213 patients underwent', 'patients with uptake PCPs vs patients with nonuptake PCPs (23 patients [16.4', 'primary health care clinics within a large, integrated health care system', 'Patients included those who had received a diagnosis of OUD, and had Providence Health Plan Medicare or Medicaid insurance']","['buprenorphine', 'educational intervention', 'Multimodal Educational Intervention']",['number of PCPs with DATA waivers'],"[{'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0282599', 'cui_str': 'Integrated Health Care Systems'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",646.0,0.0278174,"To determine whether a multimodal educational intervention of PCPs is associated with an increase in the number of buprenorphine waivers obtained and patients initiated into treatment in a primary care setting.
","[{'ForeName': 'Brinton', 'Initials': 'B', 'LastName': 'Clark', 'Affiliation': 'Department of Medical Education, Providence Portland Medical Center, Portland, Oregon.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Kai', 'Affiliation': 'Department of Medical Education, Providence Portland Medical Center, Portland, Oregon.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Dix', 'Affiliation': 'Providence Medical Group, Portland, Oregon.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Froedtert & Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Rozenfeld', 'Affiliation': 'Providence St Joseph Health, Portland, Oregon.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Levy', 'Affiliation': 'Department of Medical Education, Providence Portland Medical Center, Portland, Oregon.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Engstrom', 'Affiliation': 'Providence Medical Group, Portland, Oregon.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.13818']
1310,31642930,Effect of Frequency of Changing Point-of-Use Reminder Signs on Health Care Worker Hand Hygiene Adherence: A Cluster Randomized Clinical Trial.,"Importance
Although hand hygiene (HH) is considered the most effective strategy for preventing hospital-acquired infections, HH adherence rates remain poor.
Objective
To examine whether the frequency of changing reminder signs affects HH adherence among health care workers.
Design, Setting, and Participants
This cluster randomized clinical trial in 9 US Department of Veterans Affairs acute care hospitals randomly assigned 58 inpatient units to 1 of 3 schedules for changing signs designed to promote HH adherence among health care workers: (1) no change; (2) weekly; and (3) monthly. Hand hygiene rates among health care workers were documented at entry and exit to patient rooms during the baseline period from October 1, 2014, to March 31, 2015, of normal signage and throughout the intervention period of June 8, 2015, to December 28, 2015. Data analyses were conducted in April 2018.
Interventions
Hospital units were randomly assigned into 3 groups: (1) no sign changes throughout the intervention period, (2) signs changed weekly, and (3) signs changed monthly.
Main Outcomes and Measures
Hand hygiene adherence as measured by covert observation. Interrupted time series analysis was used to examine changes in HH adherence from baseline through the intervention period by group.
Results
Among 58 inpatient units, 19 units were assigned to the no change group, 19 units were assigned to the weekly change group, and 20 units were assigned to the monthly change group. During the baseline period, 9755 HH opportunities were observed at room entry and 10 095 HH opportunities were observed at room exit. During the intervention period, a total of 15 855 HH opportunities were observed at room entry, and 16 360 HH opportunities were observed at room exit. Overall HH adherence did not change from baseline compared with the intervention period at either room entry (4770 HH events [48.9%] vs 3057 HH events [50.1%]; P = .14) or exit (6439 HH events [63.8%] vs 4087 HH events [65.2%]; P = .06). In units that changed signs weekly, HH adherence declined from baseline at room entry (-1.9% [95% CI, -2.7% to -0.8%] per week; P < .001) and exit (-0.8% [95% CI, -1.5% to 0.1%] per week; P = .02). No significant changes in HH adherence were observed in other groups.
Conclusions and Relevance
The frequency of changing reminder signs had no effect on HH rates overall. Units assigned to change signs most frequently demonstrated worsening adherence. Considering the abundance of signs in the acute care environment, the frequency of changing signs did not appear to provide a strong enough cue by itself to promote behavioral change.
Trial Registration
ClinicalTrials.gov Identifier: NCT02223455.",2019,"In units that changed signs weekly, HH adherence declined from baseline at room entry (-1.9% [95% CI, -2.7% to -0.8%] per week; P < .001) and exit (-0.8% [95% CI, -1.5% to 0.1%] per week; P = .02).","[' 19 units were assigned to the no change group, 19 units were assigned to the weekly change group, and 20 units were assigned to the monthly change group', 'health care workers', 'Veterans Affairs acute care hospitals randomly assigned 58 inpatient units to 1 of', 'Interventions\n\n\nHospital units', '58 inpatient units']",['3 schedules for changing signs designed to promote HH adherence among health care workers'],"['HH adherence', 'Overall HH adherence', 'worsening adherence', 'Health Care Worker Hand Hygiene Adherence', 'Measures\n\n\nHand hygiene adherence']","[{'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019988', 'cui_str': 'Hospital Units'}]","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}]",58.0,0.0599596,"In units that changed signs weekly, HH adherence declined from baseline at room entry (-1.9% [95% CI, -2.7% to -0.8%] per week; P < .001) and exit (-0.8% [95% CI, -1.5% to 0.1%] per week; P = .02).","[{'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Eli N', 'Initials': 'EN', 'LastName': 'Perencevich', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Amy M J', 'Initials': 'AMJ', 'LastName': ""O'Shea"", 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Jones', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Vaughan Sarrazin', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'Franciscus', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Cassie Cunningham', 'Initials': 'CC', 'LastName': 'Goedken', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}, {'ForeName': 'Gio J', 'Initials': 'GJ', 'LastName': 'Baracco', 'Affiliation': 'Miami VA Healthcare System, Miami, Florida.'}, {'ForeName': 'Suzanne F', 'Initials': 'SF', 'LastName': 'Bradley', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cadena', 'Affiliation': 'South Texas Veterans Health Care System, San Antonio.'}, {'ForeName': 'Graeme N', 'Initials': 'GN', 'LastName': 'Forrest', 'Affiliation': 'VA Portland Health Care System, Portland, Oregon.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Morgan', 'Affiliation': 'VA Maryland Health Care System, Baltimore.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Rubin', 'Affiliation': 'VA Salt Lake City Health Care System, Salt Lake City, Utah.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Thurn', 'Affiliation': 'Minneapolis VA Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Marvin J', 'Initials': 'MJ', 'LastName': 'Bittner', 'Affiliation': 'Nebraska-Western Iowa Veterans Affairs Health Care System, Omaha, Nebraska.'}, {'ForeName': 'Heather Schacht', 'Initials': 'HS', 'LastName': 'Reisinger', 'Affiliation': 'Center for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.13823']
1311,31007350,The Persistent Effects of Youth Savings Reminders: Experimental Evidence from Text-Message Campaigns in Colombia.,"We report on a nationwide field experiment with a commercial bank in Colombia in which low-income youth (12 years old on average) who open new accounts are randomly assigned immediately after opening the account to control or to receive one of three twelve-month text-messaging campaigns: i) monthly savings reminders, ii) semimonthly reminders, iii) monthly action-oriented financial education messages. Relative to control, monthly and semimonthly reminders groups increase account balances during the campaign as a result of reduced withdrawals, potentially through savings shifts from home to bank accounts. After the campaign youth in both reminders groups continue to use the accounts but do not deplete balances. The financial education campaign had a smaller, not statistically significant, effect on account balances, but some short-term effect on reducing withdrawals, possibly through shifts from home savings.",2019,"The financial education campaign had a smaller, not statistically significant, effect on account balances, but some short-term effect on reducing withdrawals, possibly through shifts from home savings.",['nationwide field experiment with a commercial bank in Colombia in which low-income youth (12 years old on average) who open new accounts'],"['control or to receive one of three twelve-month text-messaging campaigns: i) monthly savings reminders, ii) semimonthly reminders, iii) monthly action-oriented financial education messages']",['account balances'],"[{'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0168255,"The financial education campaign had a smaller, not statistically significant, effect on account balances, but some short-term effect on reducing withdrawals, possibly through shifts from home savings.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Economics, Universidad de los Andes Calle 19A No. 1-37 Este Bloque W, Bogotá (Colombia) cathrodr@uniandes.edu.co.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Saavedra', 'Affiliation': 'Center for Economic and Social Research, University of Southern California 635 Downey Way, Los Angeles, California 90089 and National Bureau of Economic Research juansaav@usc.edu.'}]",Journal of development economics,['10.1016/j.jdeveco.2019.03.001']
1312,31722536,Impact of Autonomic Regulation Therapy in Patients with Heart Failure: ANTHEM-HFrEF Pivotal Study Design.,"BACKGROUND
The ANTHEM-HFrEF (Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction) pivotal study is an adaptive, open-label, randomized, controlled study evaluating whether autonomic regulation therapy will benefit patients with advanced HFrEF. While early-phase studies have supported potential use of vagus nerve stimulation to deliver autonomic regulation therapy for HFrEF, results of larger clinical trials have been inconsistent. The ANTHEM-HFrEF study uses a novel design, with adaptive sample size selection, evaluating effects on morbidity and mortality as well as symptoms and function.
METHODS
The ANTHEM-HFrEF study will randomize patients (2:1) to autonomic regulation therapy plus guideline-directed medical therapy, or guideline-directed medical therapy alone. The morbidity and mortality trial utilizes a conventional frequentist approach for analysis of the primary outcome end point-reduction in the composite of cardiovascular death or first HF hospitalization-and a Bayesian adaptive approach toward sample size selection. Embedded within the ANTHEM-HFrEF study is a second trial evaluating improvement in symptoms and function. Symptom/function success will require meeting 2 risk-related conditions (trend for reduced cardiovascular death/HF hospitalization and sufficient freedom from device-related serious adverse events) and 3 efficacy end point components (changes in left ventricular EF, 6-minute walk distance, and Kansas City Cardiomyopathy Questionnaire overall score).
CONCLUSIONS
Vagus nerve stimulation remains a promising, yet unproven treatment in HFrEF. A successful ANTHEM-HFrEF pivotal study would provide an important advance in HFrEF treatment and offer a model for expediting evaluation of new therapies.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT03425422.",2019,"BACKGROUND
The ANTHEM-HFrEF (Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction)","['Heart Failure with Reduced Ejection Fraction', 'patients with advanced HFrEF', 'Patients with Heart Failure']","['Autonomic Regulation Therapy', 'autonomic regulation therapy plus guideline-directed medical therapy, or guideline-directed medical therapy alone', 'autonomic regulation therapy']","['efficacy end point components (changes in left ventricular EF, 6-minute walk distance, and Kansas City Cardiomyopathy Questionnaire overall score', 'morbidity and mortality']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0928951,"BACKGROUND
The ANTHEM-HFrEF (Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction)","[{'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'The CardioVascular Center at Tufts Medical Center, Boston, MA (M.A.K., J.E.U.).'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'The CardioVascular Center at Tufts Medical Center, Boston, MA (M.A.K., J.E.U.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS (J.B.).'}, {'ForeName': 'Helmut U', 'Initials': 'HU', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, University of Rochester Medical Center, NY (H.U.K.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Parker', 'Affiliation': 'University of Toronto, Mount Sinai Hospital, Division of Cardiology, Sinai Health Systems and University Health Network, Toronto, Canada (J.D.P.).'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California (J.R.T.).'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Wedge', 'Affiliation': 'Cardiovascular Clinical Science Foundation, Boston, MA (P.M.W.).'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants LLC, Austin TX and Department of Biostatistics, Vanderbilt University, Nashville TN (B.R.S.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Ardell', 'Affiliation': 'Neurocardiology Center, University of California, Los Angeles (J.L.A.).'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Libbus', 'Affiliation': 'LivaNova USA Incorporated, Houston, TX (I.L., L.A.D.).'}, {'ForeName': 'Lorenzo A', 'Initials': 'LA', 'LastName': 'DiCarlo', 'Affiliation': 'LivaNova USA Incorporated, Houston, TX (I.L., L.A.D.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.005879']
1313,31021842,Tendon Subluxation After Surgical Release of the First Dorsal Compartment in De Quervain Disease: Are Elevation of Radial Flap Through Dorsoulnar Incision and Immobilization Effective?,"We aimed to determine whether dorsoulnar incision elevating radial flap and immobilization for the treatment of de Quervain disease have an advantage over simple midline incision and early mobilization, respectively, in terms of tendon subluxation and clinical outcomes. Forty-six patients with de Quervain disease were randomly divided into 2 groups (midline incision vs dorsoulnar incision) and 2 subgroups (immobilization vs early mobilization). Subluxation of intracompartmental tendons was measured in dynamic wrist positions at 12 and 24 weeks using ultrasonography. The DASH (Disabilities of the Arm, Shoulder, and Hand) and visual analog scale scores and grip and pinch strengths were evaluated. At 24 weeks, the tendons were displaced voloradially in wrist volar flexion (1.25 mm in midline incision vs 0.36 mm in dorsoulnar incision, P = 0.001), whereas the tendons were displaced dorsoulnarly in wrist extension (0.95 mm in midline incision vs 1.78 mm in dorsoulnar incision, P = 0.041). There were no significant differences in tendon displacement between early mobilization and immobilization groups. Clinical outcome measures showed no variation between the groups, and no significant correlation occurred with tendon subluxation. Dorsoulnar incision and postoperative immobilization do not have advantage over midline incision and early mobilization, respectively. However, tendon subluxation after release of the first dorsal compartment for de Quervain disease does not affect clinical outcomes.",2019,Subluxation of intracompartmental tendons was measured in dynamic wrist positions at 12 and 24 weeks using ultrasonography.,['Forty-six patients with de Quervain disease'],"['midline incision vs dorsoulnar incision) and 2 subgroups (immobilization vs early mobilization', 'dorsoulnar incision elevating radial flap and immobilization', 'Tendon Subluxation']","['tendon displacement', 'wrist volar flexion', 'wrist extension', 'tendon subluxation', 'DASH (Disabilities of the Arm, Shoulder, and Hand) and visual analog scale scores and grip and pinch strengths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149870', 'cui_str': 'Stenosing Tenosynovitis, De Quervain'}]","[{'cui': 'C0456276', 'cui_str': 'Midline incision (procedure)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C2036883', 'cui_str': 'Tendon subluxation'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C2036883', 'cui_str': 'Tendon subluxation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}]",46.0,0.0326615,Subluxation of intracompartmental tendons was measured in dynamic wrist positions at 12 and 24 weeks using ultrasonography.,"[{'ForeName': 'Ji-Hyo', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Career Education, College of General Education.'}, {'ForeName': 'Seog-Won', 'Initials': 'SW', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine, and.'}, {'ForeName': 'Hee-Jeong', 'Initials': 'HJ', 'LastName': 'Ham', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine, and.'}, {'ForeName': 'Jong-Pil', 'Initials': 'JP', 'LastName': 'Kim', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0000000000001860']
1314,28757827,Digital assistance of nasogastric tube insertion in intubated patients under general anesthesia: A single-blinded prospective randomized study.,"BACKGROUND
Nasogastric tube (NGT) insertion may pose a special problem in patients under general anesthesia with first attempt failure rates up to 50%. To increase insertion success rate and decreases related complications, several techniques have been developed. In this study, digital assistance technique is compared to the classic insertion technique in neck flexion.
MATERIALS AND METHODS
In this prospective randomized study, 160 patients were randomly allocated into two groups; control group (Group C, n = 80) where NGT tube will be inserted with the neck in flexion position and digital facilitation group (Group D, n = 80).
RESULTS
Overall success rate and first attempt success were statistically higher in Group D compared to Group C (94% vs. 81%, P = 0.02, 80% vs. 62%, P = 0.01 respectively) with significantly lower insertion time in Group D (13 ± 5 s. vs. 10 ± 3 s., P = 0.00).
CONCLUSIONS
Digital assistance of NGT insertion in the anesthetized or unconscious patient is an effective, fast, and safe method that can be either used as a routine technique or as a rescue in case of failed other methods.",2017,"RESULTS
Overall success rate and first attempt success were statistically higher in Group D compared to Group C (94% vs. 81%, P = 0.02, 80% vs. 62%, P = 0.01 respectively) with significantly lower insertion time in Group D (13 ± 5 s. vs. 10 ± 3 s., P = 0.00).
","['patients under general anesthesia with first attempt failure rates up to 50', 'intubated patients under general anesthesia', '160 patients']","['Nasogastric tube (NGT) insertion', 'Digital assistance of nasogastric tube insertion', 'control group (Group C, n = 80) where NGT tube will be inserted with the neck in flexion position and digital facilitation group']",['Overall success rate and first attempt success'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0204819', 'cui_str': 'Intubation, Nasogastric'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",160.0,0.0629401,"RESULTS
Overall success rate and first attempt success were statistically higher in Group D compared to Group C (94% vs. 81%, P = 0.02, 80% vs. 62%, P = 0.01 respectively) with significantly lower insertion time in Group D (13 ± 5 s. vs. 10 ± 3 s., P = 0.00).
","[{'ForeName': 'Alrefaey', 'Initials': 'A', 'LastName': 'Kandeel', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Elmorhedi', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Usama', 'Initials': 'U', 'LastName': 'Abdalla', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_524_16']
1315,31007657,"Dexmedetomidine versus fentanyl added to bupivacaine for epidural analgesia in combination with general anesthesia for elective lumbar disc operations: A prospective, randomized double-blinded study.","Background
The literature on drugs used for combined general anesthesia and epidural analgesia (CGE) in lumbar operations is scarce. The purpose of the study was to compare the addition of either dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia with regard to efficacy and adverse events in such operations.
Materials and Methods
This prospective, randomized, double-blinded study was conducted on 80 patients who were scheduled for an elective lumbar disc operation, age 20-65 years, of either sex and American Society of Anesthesiologists physical status I or II. They were randomly allocated into one of the two groups - group bupivacaine-dexmedetomidine (BD) ( n = 40): patients who received CGE with 15 mL of bupivacaine 0.20% plus 50 μg of dexmedetomidine and group bupivacaine-fentanyl (BF) ( n = 40): patients who received CGE with 15 mL of bupivacaine 0.20% plus 50 μg fentanyl. The primary outcome was time to first analgesic requirement, whereas the secondary outcomes were the total opioid consumption and pain scores during the first 24 h. The incidence of adverse postoperative (PO) effects related to the study drugs, such as sedation, nausea and vomiting, pruritus, shivering, and respiratory depression, was also documented.
Results
Patients in the BD group experienced a significantly prolonged pain-free period, lower total opioid consumption, and lower pain scores than patients in the BF group ( P < 0.001). Patients in the BD group showed a significantly lower intraoperative heart rate and mean blood pressure ( P < 0.001). Regarding adverse events, there were greater PO sedation scores ( P < 0.001) and less frequent episodes of PO nausea and vomiting in the BD group. In addition, patients in the BD group showed less pruritis and shivering. There were no reported cases of respiratory depression in either group.
Conclusion
CGE with bupivacaine plus dexmedetomidine provided better PO pain control than bupivacaine plus fentanyl, with fewer adverse events overall.",2019,Patients in the BD group showed a significantly lower intraoperative heart rate and mean blood pressure ( P < 0.001).,"[' n = 40): patients who received', '80 patients who were scheduled for an elective lumbar disc operation, age 20-65 years, of either sex and American Society of Anesthesiologists physical status I or II', 'elective lumbar disc operations']","['Dexmedetomidine', 'bupivacaine plus dexmedetomidine', 'CGE with 15 mL of bupivacaine 0.20% plus 50 μg fentanyl', 'bupivacaine', 'combined general anesthesia and epidural analgesia (CGE', 'bupivacaine plus fentanyl', 'bupivacaine-dexmedetomidine (BD', 'CGE with 15 mL of bupivacaine 0.20% plus 50 μg of dexmedetomidine and group bupivacaine-fentanyl (BF', 'dexmedetomidine']","['intraoperative heart rate and mean blood pressure', 'PO pain control', 'PO nausea and vomiting', 'PO sedation scores', 'sedation, nausea and vomiting, pruritus, shivering, and respiratory depression', 'respiratory depression', 'pruritis and shivering', 'total opioid consumption and pain scores', 'time to first analgesic requirement', 'prolonged pain-free period, lower total opioid consumption, and lower pain scores', 'adverse postoperative (PO) effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0662600', 'cui_str': 'CGE(N)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",80.0,0.200891,Patients in the BD group showed a significantly lower intraoperative heart rate and mean blood pressure ( P < 0.001).,"[{'ForeName': 'Amin Mohammed', 'Initials': 'AM', 'LastName': 'Alansary', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Marwa Ahmed Khairy', 'Initials': 'MAK', 'LastName': 'Elbeialy', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_600_18']
1316,31007654,Postoperative analgesia with ropivacaine and dexmedetomidine for ultrasound-guided fascia iliaca compartment block after arthroscopic knee surgery.,"Objective
The objective of this study is to evaluate the postoperative analgesic effect of a combination of ropivacaine and dexmedetomidine for ultrasound-guided fascia iliaca compartment block (FICB) after knee arthroscopy.
Materials and Methods
Forty patients scheduled for knee arthroscopy were randomized to receive either 30 ml of 0.25% ropivacaine alone (Group A, n = 20) or combined with dexmedetomidine 1 μg/kg (Group B, n = 20). Pain intensity was evaluated using the visual analogue scale (VAS), at rest and during activity at 4, 6, 8, 12, and 24 h after surgery. Level of consciousness was evaluated using the Ramsay sedation score. Time to first analgesic request after surgery, the dose of analgesic used in the first 24 h after surgery, variation of heart rate, and adverse reactions were also recorded.
Results
VAS scores at 6 and 12 h after surgery were significantly lower in Group B compared to Group A ( P < 0.05). No significant difference was observed in the Ramsay sedation score or time to first analgesic request after surgery ( P > 0.05). The total dose of analgesic used in the first 24 h after surgery was higher in Group A than in Group B. The incidence of bradycardia was higher in Group B compared to Group A. No adverse reactions were observed in either group.
Conclusion
FICB with a combination of ropivacaine and dexmedetomidine resulted in significant reduction of VAS scores with lower postoperative analgesic requirement after arthroscopic knee surgery. No adverse reactions or complications were noted except for lower heart rate in Group B patients.",2019,No significant difference was observed in the Ramsay sedation score or time to first analgesic request after surgery ( P > 0.05).,"['Forty patients scheduled for knee arthroscopy', 'arthroscopic knee surgery']","['30 ml of 0.25% ropivacaine alone (Group A, n = 20) or combined with dexmedetomidine', 'ropivacaine', 'ropivacaine and dexmedetomidine', 'dexmedetomidine']","['postoperative analgesic effect', 'heart rate', 'Pain intensity', 'variation of heart rate, and adverse reactions', 'incidence of bradycardia', 'adverse reactions', 'Ramsay sedation score or time to first analgesic request', 'VAS scores', 'visual analogue scale (VAS', 'Level of consciousness', 'adverse reactions or complications']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}]","[{'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0234425', 'cui_str': 'Level of consciousness (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",40.0,0.0524958,No significant difference was observed in the Ramsay sedation score or time to first analgesic request after surgery ( P > 0.05).,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital, Affiliated to Southeast University Medical School, Jiangyin, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital, Affiliated to Southeast University Medical School, Jiangyin, China.'}, {'ForeName': 'Laiyou', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital, Affiliated to Southeast University Medical School, Jiangyin, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital, Affiliated to Southeast University Medical School, Jiangyin, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital, Affiliated to Southeast University Medical School, Jiangyin, China.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_533_18']
1317,31031314,Short- and long-term results after laparoscopic floppy Nissen fundoplication in elderly versus non-elderly patients.,"Background
Laparoscopic anti-reflux surgery could be of benefit in a subset of elderly patients with gastroesophageal reflux disease. However, there are few reports that have evaluated the long-term results. This study examined the effects of age on the short- and long-term (for at least 5 years) outcomes after laparoscopic Nissen fundoplication (LNF).
Patients and Methods
Patients were divided into four groups as follows: young (18-49); adult (50-69); and elderly (70-84), and very elderly (85-91). The database (recorded prospectively) included operating duration, conversion, intra- and early post-operative complication and late outcomes. Mean follow-up was 14.5 years (range 5-24 years).
Results
Five hundred and sixty-nine patients met the inclusion criteria: young n = 219 (38.4%); adult n = 248 (43.5%); elderly n = 91 (16.0%) and very elderly n = 11 (1.9%). Hiatal hernia (type I and III) was significantly less frequent in young and adult patients (P < 0.0001). The operation was significantly longer in elderly and very elderly patients (P < 0.001); the use of drains (P < 0.001) and grafts (P < 0.0001) for hiatal hernia repair was less in young and adult patients. The hospital stay, conversion (5.4%), intra-operative and early post-operative complications were not influenced by age. Dysphagia was evenly distributed among the groups. Forty-eight (8.4%) patients had recurrence: 15 in the young group (6.8%), 18 in the adult group (7.2%), 11 in the elderly group (12%) and 4 in the very elderly group (36.3%) (P < 0.0001).
Conclusions
Age does not influence short- and long-term outcomes following LNF. Control of reflux in the elderly is worse than adult patients. Therefore, ageing is a relative contraindication to LNF.",2020,The operation was significantly longer in elderly and very elderly patients (P < 0.001); the use of drains (P < 0.001) and grafts (P < 0.0001) for hiatal hernia repair was less in young and adult patients.,"['Five hundred and sixty-nine patients met the inclusion criteria: young n = 219 (38.4%); adult n = 248 (43.5%); elderly n = 91 (16.0%) and very elderly n = 11 (1.9', 'elderly patients with gastroesophageal reflux disease', 'elderly versus non-elderly patients', 'young (18-49); adult (50-69); and elderly (70-84), and very elderly (85-91']","['LNF', '\n\n\nLaparoscopic anti-reflux surgery', 'laparoscopic Nissen fundoplication (LNF', 'laparoscopic floppy Nissen fundoplication']","['Hiatal hernia (type I and III', 'hiatal hernia repair', 'operating duration, conversion, intra- and early post-operative complication and late outcomes', 'hospital stay, conversion (5.4%), intra-operative and early post-operative complications', 'recurrence', 'Dysphagia']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}]","[{'cui': 'C0399651', 'cui_str': 'Antireflux operation (procedure)'}, {'cui': 'C3887679', 'cui_str': 'Nissen Operation'}, {'cui': 'C0857516', 'cui_str': 'Floppy'}]","[{'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",569.0,0.0250195,The operation was significantly longer in elderly and very elderly patients (P < 0.001); the use of drains (P < 0.001) and grafts (P < 0.0001) for hiatal hernia repair was less in young and adult patients.,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Schietroma', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Colozzi', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Romano', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Pessia', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Giuliani', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Vicentini', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Carlo Luigi', 'Initials': 'CL', 'LastName': 'Recchia', 'Affiliation': 'Department of Surgery, Hospital SS. Trinità, Sora, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carlei', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_269_18']
1318,31031325,A prospective randomized controlled trial comparing conventional Intuitive® procedure card recommended port placement with the modified Indian (Manipal) technique.,"Introduction
The da Vinci ® X hybrid systems (Intuitive Surgical ® , Sunnyvale CA) provides standard sites recommendations for port placement during robotic surgery; including that for colorectal procedures. The author's encountered challenges while adhering to the provided instructions, such as clash of instruments and arms and need for additional ports, and hence to overcome these challenges attempted a few innovative technical modifications. The surgical results as well as merits of the revised Indian (Manipal) port placement with single docking technique are presented here.
Methods
Twenty patients underwent robotic rectal resection at the Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, India, between December 2017 and June 2018. A randomised controlled study was conducted to compare the two techniques. Ten patients were operated using hybrid da Vinci ® 'X' system using the manufacturer's recommendations and 10 by the modified Indian (Manipal) port placement with a single docking technique.
Result and Conclusions
The Indian (Manipal) modifications of port placements are optimal for colorectal procedures such as low anterior resection as well as for ultralow anterior resections. The intraoperative parameters compared between the recommendations of the Intuitive ® (da Vinci ® systems) and attempted modifications demonstrated statistically significant advantages with the use of the revised techniques. The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.",2020,"The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.","['Twenty patients underwent robotic rectal resection at the Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, India, between December 2017 and June 2018']","[""hybrid da Vinci ® 'X' system using the manufacturer's recommendations and 10 by the modified Indian (Manipal) port placement with a single docking technique"", 'conventional Intuitive® procedure card recommended port placement with the modified Indian (Manipal) technique']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1515090', 'cui_str': 'Surgical Oncology'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",[],10.0,0.0180383,"The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.","[{'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Somashekhar', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Deshpande', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Ashwin', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gangasani', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_18_19']
1319,31023190,Randomized Controlled Trial of an Internet-Based Educational Intervention for Mothers With Mental Illnesses: An 18-Month Follow-Up.,"OBJECTIVE
A randomized controlled trial was conducted to examine the effectiveness of an Internet-based educational intervention plus a peer support-moderated listserv for improving parenting skills and coping and reducing parental stress among mothers with serious mental illnesses. The analyses examined whether positive results achieved immediately after the intervention were improved upon during the 18-month postbaseline period.
METHODS
Mothers with serious mental illnesses (N=131) were randomly assigned to an experimental or an active control condition. Outcomes were assessed over time by using a repeated-measures analysis of variance.
RESULTS
Participants in the experimental condition experienced statistically greater reduction in parental stress at the 18-month follow-up than those in the active control condition.
CONCLUSIONS
This relatively low-cost intervention, along with the Internet's advantages of accessibility, anonymity, and insulation from child care issues, suggests potential utility for reducing parenting stress for busy mothers. These results provide a foundation for enhancing this intervention to achieve other targeted outcomes related to parenting.",2019,"RESULTS
Participants in the experimental condition experienced statistically greater reduction in parental stress at the 18-month follow-up than those in the active control condition.
","['mothers with serious mental illnesses', 'Mothers with serious mental illnesses (N=131', 'busy mothers', 'Mothers With Mental Illnesses']","['Internet-Based Educational Intervention', 'Internet-based educational intervention plus a peer support-moderated listserv']","['parenting skills and coping and reducing parental stress', 'parental stress']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",131.0,0.095038,"RESULTS
Participants in the experimental condition experienced statistically greater reduction in parental stress at the 18-month follow-up than those in the active control condition.
","[{'ForeName': 'Amber', 'Initials': 'A', 'LastName': ""O'Shea"", 'Affiliation': ""Department of Educational Psychology, Counseling, and Special Education, Pennsylvania State University, University Park (O'Shea); Collaborative on Community Inclusion of Individuals With Psychiatric Disabilities (Kaplan) and Department of Rehabilitation Sciences (Salzer), Temple University, Philadelphia; Department of Research, Social Policy, and Practice, University of Pennsylvania, Philadelphia (Solomon).""}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Kaplan', 'Affiliation': ""Department of Educational Psychology, Counseling, and Special Education, Pennsylvania State University, University Park (O'Shea); Collaborative on Community Inclusion of Individuals With Psychiatric Disabilities (Kaplan) and Department of Rehabilitation Sciences (Salzer), Temple University, Philadelphia; Department of Research, Social Policy, and Practice, University of Pennsylvania, Philadelphia (Solomon).""}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Solomon', 'Affiliation': ""Department of Educational Psychology, Counseling, and Special Education, Pennsylvania State University, University Park (O'Shea); Collaborative on Community Inclusion of Individuals With Psychiatric Disabilities (Kaplan) and Department of Rehabilitation Sciences (Salzer), Temple University, Philadelphia; Department of Research, Social Policy, and Practice, University of Pennsylvania, Philadelphia (Solomon).""}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Salzer', 'Affiliation': ""Department of Educational Psychology, Counseling, and Special Education, Pennsylvania State University, University Park (O'Shea); Collaborative on Community Inclusion of Individuals With Psychiatric Disabilities (Kaplan) and Department of Rehabilitation Sciences (Salzer), Temple University, Philadelphia; Department of Research, Social Policy, and Practice, University of Pennsylvania, Philadelphia (Solomon).""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800391']
1320,30996552,The Direction of Double-Jaw Surgery Relapse for Correction of Skeletal Class III Deformity: Bilateral Sagittal Split Versus Intraoral Vertical Ramus Setback Osteotomies.,"Objectives
This prospective comparative clinical trial study aims to investigate the postoperative stability of the double-jaw surgical treatment of skeletal Class III deformity and to compare two different mandibular surgical approaches. The study goal is to locate the relapsing direction of both the maxilla and the distal segment after either bilateral sagittal split ramus osteotomy (BSSO), or intraoral vertical ramus osteotomy (IVRO).
Methods
Twenty-two (22) patients with skeletal Class III were included in this study. The patients were treated with double-jaw surgery by LeFort I osteotomy combined with either BSSO or IVRO. Lateral cephalograms taken before (T0), immediately after (T1), and 1 year after the surgery (T2) were studied and analyzed.
Result
The mean mandibular setback and maxillary advancement in the BSSO group were 6.22 mm at B Point and 2.93 mm at A point with relapse percentages of 24.9 and 26.6%, respectively, while the mean mandibular setback and maxillary advancement in the IVRO group were 2.55 mm at B point and 5.89 mm at A point with relapse percentages of 22.1 and 23.5%, respectively. The magnitude of the setback significantly accounted for the relapse.
Conclusion
One-year follow-up revealed that the maxilla would be displaced posteriorly and inferiorly in both groups. Regarding the direction of the mandibular relapse, the mandible in BSSO surgical group was displaced forward and upward, while in IVRO surgical group, the directions were completely different in which the mandible is displaced backward and downward.",2019,"Conclusion
One-year follow-up revealed that the maxilla would be displaced posteriorly and inferiorly in both groups.",['Methods\n\n\nTwenty-two (22) patients with skeletal Class III were included in this study'],"['BSSO or IVRO', 'Sagittal Split Versus Intraoral Vertical Ramus Setback Osteotomies', 'double-jaw surgery by LeFort', 'bilateral sagittal split ramus osteotomy (BSSO), or intraoral vertical ramus osteotomy (IVRO']",['mean mandibular setback and maxillary advancement'],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0616096', 'cui_str': 'BSSO'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0407713', 'cui_str': 'Jaw Surgery'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}]",,0.02986,"Conclusion
One-year follow-up revealed that the maxilla would be displaced posteriorly and inferiorly in both groups.","[{'ForeName': ""Ra'ed Mohammed Ayoub"", 'Initials': 'RMA', 'LastName': 'Al-Delayme', 'Affiliation': '1Eastman Institute for Oral Health, University of Rochester, School of Medicine and Dentistry, New York, USA.'}, {'ForeName': 'Ali Arkan Redha', 'Initials': 'AAR', 'LastName': 'Alsagban', 'Affiliation': '2Faculty of Dentistry, Dijlah University College, Baghdad, Iraq.'}, {'ForeName': 'Fires Taha', 'Initials': 'FT', 'LastName': 'Ahmed', 'Affiliation': 'Oral and Maxillofacial Department, Al-Shaheed Ghazi Al-Hariri Specialized Surgeries, Baghdad, Iraq.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Farag', 'Affiliation': '5University of Vermont Health Network - AHMC, Malone, NY USA.'}, {'ForeName': 'Tumouh', 'Initials': 'T', 'LastName': 'Al-Allaq', 'Affiliation': 'Chesapeake Health Care, Princess Anne, Maryland, USA.'}, {'ForeName': 'Parveen', 'Initials': 'P', 'LastName': 'Virdee', 'Affiliation': '1Eastman Institute for Oral Health, University of Rochester, School of Medicine and Dentistry, New York, USA.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Alnajjar', 'Affiliation': 'Chesapeake Health Care, Princess Anne, Maryland, USA.'}, {'ForeName': 'Sufian Alaa Ibraheem', 'Initials': 'SAI', 'LastName': 'Alsamaraie', 'Affiliation': 'Romo dental, Chicago, Illinois USA.'}, {'ForeName': 'Salih', 'Initials': 'S', 'LastName': 'Elnashef', 'Affiliation': '1Eastman Institute for Oral Health, University of Rochester, School of Medicine and Dentistry, New York, USA.'}, {'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Arab', 'Affiliation': '8Oral and Maxillofacial Surgery Department, University of Washington, Seattle, USA.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Yassin', 'Affiliation': '9Graduate Periodontics Department, University of Washington, Seattle, USA.'}, {'ForeName': 'Moutaz', 'Initials': 'M', 'LastName': 'Al-Khen', 'Affiliation': '10Oral and Maxillofacial Department, Damascus Hospital, Damascus, Syria.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-018-1127-y']
1321,31502354,Immediate effects of Mulligan's techniques on pain and functional mobility in individuals with knee osteoarthritis: A randomized control trial.,"BACKGROUND AND PURPOSE
Mulligan's mobilization with movement was shown to be effective when implemented in multimodal therapy for knee osteoarthritis. However, no study has evaluated the Mulligan's technique in isolation and compared the relative effectiveness with sham-controlled interventions. Hence, the present study examined the immediate effects of Mulligan's techniques with sham mobilization on the numerical pain rating scale (NPRS) and timed up and go (TUG) test in individuals with knee osteoarthritis.
METHODS
Thirty participants (mean age: 55.3 ± 8.3 years) with symptoms at the knee and radiographic diagnosis of knee osteoarthritis were randomized into sham (n = 15) and intervention (n = 15) groups. The intervention (I) group received Mulligan's mobilization glides that resulted in relative pain relief for three sets of 10 repetitions. For the sham (S) group, the therapist's hand was placed over the joint surfaces mimicking the pain-relieving glides, without providing the gliding force. The outcome measures NPRS and TUG were recorded by a blinded assessor pre- and post-intervention.
RESULTS
Statistically significant differences were identified between the groups in post-intervention median (interquartile range) NPRS (I group: 4.00 [2.00-5.00]; S group: 6.00 [4.00-7.00]) and TUG scores (I group: 10.9 [9.43-10.45]; S group: 13.18 [10.38-16.00]) with the intervention group demonstrating better outcomes (p < .05). Within-group, the post-intervention scores of NPRS and TUG were significantly lower (p < .05) compared to the pre-intervention scores in the intervention group. In the sham group, a statistically significant pre-post change was noticed only in the NPRS scores but not in the TUG scores.
CONCLUSION
Mulligan's techniques were effective in improving pain and functional mobility in individuals with knee osteoarthritis. The underlying mechanisms for observed effects must be examined further, as participants reported pain relief following sham mobilization.",2020,"Within-group, the post-intervention scores of NPRS and TUG were significantly lower (p < .05) compared to the pre-intervention scores in the intervention group.","['individuals with knee osteoarthritis', 'Thirty participants (mean age: 55.3 ± 8.3 years) with symptoms at the knee and radiographic diagnosis of knee osteoarthritis']","[""therapist's hand was placed over the joint surfaces mimicking the pain-relieving glides, without providing the gliding force"", ""Mulligan's techniques"", ""Mulligan's mobilization glides""]","['numerical pain rating scale (NPRS) and timed up and go (TUG) test', 'NPRS scores', 'relative pain relief', 'TUG scores', 'NPRS and TUG', 'pain relief', 'pain and functional mobility']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",30.0,0.0393228,"Within-group, the post-intervention scores of NPRS and TUG were significantly lower (p < .05) compared to the pre-intervention scores in the intervention group.","[{'ForeName': 'Madhura', 'Initials': 'M', 'LastName': 'Bhagat', 'Affiliation': 'Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Y V Raghava', 'Initials': 'YVR', 'LastName': 'Neelapala', 'Affiliation': 'Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Ranganath', 'Initials': 'R', 'LastName': 'Gangavelli', 'Affiliation': 'Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1812']
1322,30449328,"Does memantine improve memory in subjects with focal-onset epilepsy and memory dysfunction? A randomized, double-blind, placebo-controlled trial.","OBJECTIVE
Excitotoxic injury involving N-methyl-d-aspartate (NMDA) receptor hyperactivity contributes to epilepsy-related memory dysfunction (ERMD). Current treatment strategies for ERMD have limited efficacy and fail to target the underlying pathophysiology. The present pilot study evaluated the efficacy of memantine, an NMDA receptor antagonist, for the treatment of ERMD in adults with focal-onset seizures.
METHODS
Subjects underwent cognitive testing at baseline, after a 13-week randomized, parallel-group, double-blinded phase (of memantine titrated to 10 mg bid or placebo), and following a 13-week open-label extension phase (of memantine titrated to 10 mg bid). The selective reminding test (SRT) continuous long-term retrieval (CLTR) score and 7/24 Spatial Recall Test learning score served as the primary outcome measures. Secondary measures included tests of attention span, fluency, visual construction, and response inhibition, as well as assessments of quality of life, depression, sleepiness, and side effects.
RESULTS
Seventeen subjects contributed data to the blinded phase (n = 8 memantine, n = 9 placebo). No significant differences were seen between groups on the primary or secondary outcome measures. Pooled data at the end of the open-label phase from 10 subjects (initially randomized to memantine n = 3 or placebo n = 7) demonstrated statistically significant improvement from baseline in CLTR score, memory-related quality of life, spatial span, and response inhibition. No significant changes were evident in depression, sleepiness, side effects, or seizure frequency throughout the trial.
SIGNIFICANCE
Results demonstrated no significant effect of memantine on cognition when assessed at the end of the blinded period. Pooled data at the end of the open-label phase showed significant improvement over baseline performance in measures of verbal memory, frontal-executive function, and memory-related quality of life. These improvements, however, may be due to practice effects and should be interpreted cautiously. Findings suggest a favorable safety profile of memantine in the setting of epilepsy.",2018,No significant differences were seen between groups on the primary or secondary outcome measures.,"['Subjects underwent cognitive testing at baseline', 'subjects with focal-onset epilepsy and memory dysfunction', 'adults with focal-onset seizures']","['memantine titrated to 10\u202fmg bid or placebo', 'memantine', 'placebo', 'N-methyl-d-aspartate (NMDA) receptor hyperactivity']","['CLTR score, memory-related quality of life, spatial span, and response inhibition', 'verbal memory, frontal-executive function, and memory-related quality of life', 'selective reminding test (SRT) continuous long-term retrieval (CLTR) score and 7/24 Spatial Recall Test learning score', 'tests of attention span, fluency, visual construction, and response inhibition, as well as assessments of quality of life, depression, sleepiness, and side effects', 'depression, sleepiness, side effects, or seizure frequency']","[{'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C3887551', 'cui_str': 'Memory dysfunction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0557033', 'cui_str': 'Reminding (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",17.0,0.429504,No significant differences were seen between groups on the primary or secondary outcome measures.,"[{'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Leeman-Markowski', 'Affiliation': 'Research Service, VA New York Harbor Healthcare System, New York, NY, USA; Department of Neurology, New York University Langone Medical Center, New York, NY, USA. Electronic address: beth.leeman-markowski@nyumc.org.'}, {'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology & Neurological Sciences, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Moo', 'Affiliation': 'Geriatric Research Education and Clinical Center, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA; Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cole', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Hoch', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Garcia', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA; Newton-Wellesley Neurology Associates, PC, Newton Lower Falls, MA, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Schachter', 'Affiliation': 'Harvard Medical School, Boston, MA, USA; Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2018.06.047']
1323,30891688,Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment.,"BACKGROUND
Primary care-based digital health weight loss interventions offer promise for addressing obesity in underserved populations.
OBJECTIVES
To determine if primary care providers' weight counseling is associated with weight change during a weight loss intervention.
DESIGN
This is a secondary analysis of a randomized clinical trial testing a 12-month primary care-based digital health weight loss intervention.
PARTICIPANTS
Participants were community health center patients with body mass indexes of 30-44.9 kg/m 2 .
INTERVENTIONS
The weight loss intervention included tailored behavioral goal setting; weekly goal monitoring via text messaging or interactive voice response calls; counseling calls; skills training material; and participant-tailored recommendations for provider counseling.
MAIN MEASURES
At 6 and 12 months, participants' weight was measured and they reported if their provider delivered weight counseling (general or intervention-specific) at their most recent visit and their perception of providers' empathy. Providers' documentation of weight counseling was extracted from health records.
KEY RESULTS
Participants (n = 134-141) were predominantly female (70%) and African American (55%) with a mean age of 51 years and BMI of 36 kg/m 2 . Participant-reported provider weight counseling was not associated with weight change. However, participants whose providers documented intervention-specific counseling at any point during the intervention (n = 35) lost 3.1 kg (95% CI 0.4 to 5.7 kg) more than those whose providers documented only general weight counseling (n = 82) and 4.0 kg (95% CI 0.1 to 7.9 kg) more than those whose providers did not document weight counseling (n = 17). Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03).
CONCLUSIONS
Provider counseling that focuses specifically on engagement in a weight loss intervention may enhance weight loss outcomes relative to more general weight loss advice. Counseling that enhances patients' perceptions of empathy may be most beneficial for patients' weight loss.
TRIAL REGISTRATION
NCT01827800.",2019,"Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03).
","['134-141) were predominantly female (70%) and African American (55%) with a mean age of 51\xa0years and BMI of 36\xa0kg/m 2 ', 'Participants (n\u2009', 'Participants were community health center patients with body mass indexes of 30-44.9\xa0kg/m 2 ']",['goal monitoring via text messaging or interactive voice response calls; counseling calls; skills training material; and participant-tailored recommendations for provider counseling'],"['general weight counseling', 'weight loss']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",141.0,0.0414384,"Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03).
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McVay', 'Affiliation': 'Department of Health Education and Behavior, University of Florida, Gainesville, FL, USA. Megan.mcvay@ufl.edu.'}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Steinberg', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Askew', 'Affiliation': 'Duke Global Digital Health Science Center, Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Duke Global Digital Health Science Center, Duke Global Health Institute, Duke University, Durham, NC, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04944-5']
1324,30810700,Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial.,"Importance
It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia.
Objective
To describe baseline characteristics of participants enrolled and randomized in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate whether qualification by stress imaging or nonimaging exercise tolerance test (ETT) influenced risk profiles.
Design, Setting, and Participants
The ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing. Blinded coronary computed tomography angiography was performed in most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (<50% for imaging stress test and <70% for ETT). The study included 341 enrolling sites (320 randomizing) in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing. Data presented were extracted on December 17, 2018.
Main Outcomes and Measures
Enrolled, excluded, and randomized participants' baseline characteristics. No clinical outcomes are reported.
Results
A total of 8518 patients were enrolled, and 5179 were randomized. Common reasons for exclusion were core laboratory determination of insufficient ischemia, unprotected left main stenosis of at least 50%, or no stenosis that met study obstructive CAD criteria on study coronary computed tomography angiography. Randomized participants had a median age of 64 years, with 1168 women (22.6%), 1726 nonwhite participants (33.7%), 748 Hispanic participants (15.5%), 2122 with diabetes (41.0%), and 4643 with a history of angina (89.7%). Among the 3909 participants randomized after stress imaging, core laboratory assessment of ischemia severity (in 3901 participants) was severe in 1748 (44.8%), moderate in 1600 (41.0%), mild in 317 (8.1%) and none or uninterpretable in 236 (6.0%), Among the 1270 participants who were randomized after nonimaging ETT, core laboratory determination of ischemia severity (in 1266 participants) was severe (an eligibility criterion) in 1051 (83.0%), moderate in 101 (8.0%), mild in 34 (2.7%) and none or uninterpretable in 80 (6.3%). Among the 3912 of 5179 randomized participants who underwent coronary computed tomography angiography, 79.0% had multivessel CAD (n = 2679 of 3390) and 86.8% had left anterior descending (LAD) stenosis (n = 3190 of 3677) (proximal in 46.8% [n = 1749 of 3739]). Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging.
Conclusions and Relevance
The ISCHEMIA trial randomized an SIHD population with moderate or severe ischemia on stress testing, of whom most had multivessel CAD.
Trial Registration
ClinicalTrials.gov Identifier: NCT01471522.",2019,"Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging.
","['Participants\n\n\nThe ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing', 'most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (<50% for imaging stress test and <70% for ETT', '341 enrolling sites (320 randomizing) in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing', '3912 of 5179 randomized participants who underwent coronary computed tomography angiography, 79.0% had multivessel CAD (n\u2009=\u20092679 of 3390) and 86.8% had left anterior descending (LAD) stenosis (n\u2009=\u20093190 of 3677) (proximal in 46.8% [n\u2009=\u20091749 of 3739', 'Randomized participants had a median age of 64 years, with 1168 women (22.6%), 1726 nonwhite participants (33.7%), 748 Hispanic participants (15.5%), 2122 with diabetes (41.0%), and 4643 with a history of angina (89.7', 'A total of 8518 patients were enrolled, and 5179 were randomized', 'patients with stable ischemic heart disease (SIHD', 'SIHD population with moderate or severe ischemia on stress testing, of whom most had multivessel CAD', '3909 participants randomized after', '1270 participants who were randomized after nonimaging ETT, core laboratory determination of ischemia severity (in 1266 participants) was severe (an eligibility criterion) in 1051 (83.0%), moderate in 101 (8.0%), mild in 34 (2.7%) and none or uninterpretable in 80 (6.3']","['coronary computed tomography angiography', 'qualification by stress imaging or nonimaging exercise tolerance test (ETT']","['stress imaging, core laboratory assessment of ischemia severity', 'frequency of 3-vessel CAD, LAD, and proximal LAD stenosis']","[{'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0441998', 'cui_str': 'Left anterior (qualifier value)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0450319', 'cui_str': '1051'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C4319697', 'cui_str': '6.3'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1304755', 'cui_str': 'Exercise electrocardiogram'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",8518.0,0.382172,"Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging.
","[{'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'Cardiovascular Clinical Research Center, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'Cardiovascular Clinical Research Center, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': 'Cardiovascular Clinical Research Center, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA New England Healthcare System Boston, Boston, Massachusetts.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz, Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland Hospital, Auckland, New Zealand.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy.'}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': 'St Louis University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Cyr', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': 'All India Institutes of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Ruzyllo', 'Affiliation': 'The Cardinal Stefan Wyszyński Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Gurpreet S', 'Initials': 'GS', 'LastName': 'Wander', 'Affiliation': 'Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Chernyavskiy', 'Affiliation': 'E. Meshalkin National Medical Research Center, Ministry of Health of the Russian Federation, Novosibirsk, Russia.'}, {'ForeName': 'Yves D', 'Initials': 'YD', 'LastName': 'Rosenberg', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.0014']
1325,31002578,Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study.,"PURPOSE
To evaluate the impact of two different intraperitoneal (IP) chemotherapy regimens on progression-free survival (PFS) among women with newly diagnosed advanced ovarian carcinoma.
METHODS
Eligible patients were randomly assigned to six cycles of IV paclitaxel 80 mg/m 2 once per week with intravenous (IV) carboplatin area under the curve 6 (IV carboplatin) versus IV paclitaxel 80 mg/m 2 once per week with IP carboplatin area under the curve 6 (IP carboplatin) versus once every 3 weeks IV paclitaxel 135 mg/m 2 over 3 hours day 1, IP cisplatin 75 mg/m 2 day 2, and IP paclitaxel 60 mg/m 2 day 8 (IP cisplatin). All participants received bevacizumab 15 mg/kg IV every 3 weeks in cycles 2 to 22.
RESULTS
A total of 1,560 participants were enrolled and had 84.8 months of follow-up. The median PFS duration was 24.9 months in the IV carboplatin arm, 27.4 months in the IP carboplatin arm, and 26.2 months in the IP cisplatin arm. For the subgroup of 1,380 patients with stage II/III and residual disease of 1 cm or less, median PFS was 26.9 (IV-carboplatin), 28.7 (IP-carboplatin), and 27.8 months (IP cisplatin), respectively. Median PFS for patients with stage II/III and no residual disease was 35.9, 38.8, and 35.5 months, respectively. Median overall survival for all enrolled was 75.5, 78.9, and 72.9 months, respectively, and median overall survival for stage II/III with no gross residual disease was 98.8 months, 104.8 months, and not reached. Mean patient-reported Functional Assessment of Cancer Therapy neurotoxicity scores (Gynecologic Oncology Group) were similar for all arms, but the mean Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary scores during chemotherapy were statistically worse in the IP cisplatin arm.
CONCLUSION
Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.",2019,"Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.","['1,560 participants were enrolled and had 84.8 months of follow-up', 'women with newly diagnosed advanced ovarian carcinoma', 'Advanced Ovarian Carcinoma', 'Eligible patients', '1,380 patients with stage II/III and residual disease of 1 cm or less']","['intraperitoneal (IP) chemotherapy regimens', 'bevacizumab', 'IV paclitaxel 80 mg/m 2 once per week with intravenous (IV) carboplatin area under the curve 6 (IV carboplatin) versus IV paclitaxel 80 mg/m 2 once per week with IP carboplatin area under the curve 6 (IP carboplatin', 'Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab', 'paclitaxel 135 mg/m 2 over 3 hours day 1, IP cisplatin 75 mg/m 2 day 2, and IP paclitaxel', 'IP cisplatin']","['Mean patient-reported Functional Assessment of Cancer Therapy neurotoxicity scores', 'progression-free survival (PFS', 'mean Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary scores', 'median PFS duration', 'duration of PFS', 'median overall survival', 'median PFS', 'Median overall survival', 'Median PFS']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029925'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1560.0,0.234568,"Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.","[{'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Walker', 'Affiliation': '1 University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': '2 Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Lari', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': '3 University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': '4 The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': '2 Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': '5 Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': '6 Saitama Medical University International Medical Center, Hidaka-Shi, Japan.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': '7 The University of Arizona Cancer Center, Tucson, AZ.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': '8 The University of Arizona, Tucson, AZ.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': '3 University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cohn', 'Affiliation': '9 The Ohio State University, Columbus, OH.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Powell', 'Affiliation': '10 Washington University in St Louis, St Louis, MO.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Le', 'Affiliation': '11 University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Davidson', 'Affiliation': '12 University of Colorado, Aurora, CO.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Gray', 'Affiliation': '13 University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Rose', 'Affiliation': '14 Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': '15 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Tashanna', 'Initials': 'T', 'LastName': 'Myers', 'Affiliation': '16 University of Connecticut, Storrs, CT.'}, {'ForeName': 'Angeles', 'Initials': 'A', 'LastName': 'Alvarez Secord', 'Affiliation': '17 Duke University Health System, Durham, NC.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Rubin', 'Affiliation': '18 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': '1 University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01568']
1326,30996539,Correlation Between Clinical Course and Biochemical Analysis in Odontogenic Space Infections.,"Objective
To correlate the clinical course and biochemical analysis in odontogenic space infections.
Methods
A randomized prospective study was undertaken in 50 patients presenting with infections of odontogenic origin. The data were subjected to statistical analysis to co-relate the values of CRP, WBC count and ESR with the clinical course of odontogenic infections. The statistical analysis was carried out using SPSS Version 17.0 clinical parameters included pain, swelling, mouth opening, dyspnea, dysphagia, hoarseness, body temperature, active discharge, length of hospital stay and number of fascial spaces involved.
Results
There was a significant correlation between all the clinical parameters and biochemical markers preoperatively as well as on various postoperative days.
Conclusion
According to the percentage rate of fall, CRP was considered as the best indicator of clinical course/recovery of the patient, followed by WBC count and ESR, respectively.",2019,"The statistical analysis was carried out using SPSS Version 17.0 clinical parameters included pain, swelling, mouth opening, dyspnea, dysphagia, hoarseness, body temperature, active discharge, length of hospital stay and number of fascial spaces involved.
",['50 patients presenting with infections of odontogenic origin'],[],"['pain, swelling, mouth opening, dyspnea, dysphagia, hoarseness, body temperature, active discharge, length of hospital stay and number of fascial spaces involved']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]",50.0,0.0264393,"The statistical analysis was carried out using SPSS Version 17.0 clinical parameters included pain, swelling, mouth opening, dyspnea, dysphagia, hoarseness, body temperature, active discharge, length of hospital stay and number of fascial spaces involved.
","[{'ForeName': 'Amreen', 'Initials': 'A', 'LastName': 'Kaur', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, Amritsar, Punjab 143006 India.'}, {'ForeName': 'Amneet', 'Initials': 'A', 'LastName': 'Sandhu', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, Amritsar, Punjab 143006 India.'}, {'ForeName': 'Tejinder', 'Initials': 'T', 'LastName': 'Kaur', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, Amritsar, Punjab 143006 India.'}, {'ForeName': 'Ramandeep Singh', 'Initials': 'RS', 'LastName': 'Bhullar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, Amritsar, Punjab 143006 India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dhawan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, Amritsar, Punjab 143006 India.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, Amritsar, Punjab 143006 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-018-1132-1']
1327,30996547,Bite Force as a Parameter for Comparison Between Three-Dimensional and Standard Titanium Miniplates for the Management of Anterior Mandibular Fractures: A Prospective Randomized Double-Blinded Clinical Trial.,"Background and Objectives
To compare the efficacy of three-dimensional (3D) miniplates with standard miniplates in the osteosynthesis of anterior mandibular fractures on the basis of bite force recordings and other clinical parameters.
Methods
A prospective randomized double-blinded clinical trial was carried out for the treatment of anterior mandibular fractures. In total, 20 patients were randomly divided into two groups of 2-mm 3D and standard titanium miniplates. The assessment of patients was done at weekly intervals for 6 weeks using bite force recordings and other clinical parameters.
Results
A statistically significant difference was found in the duration of surgery which was less in group A as compared to group B ( p = 0.03). No significant difference was found in other clinical parameters.
Interpretation and Conclusion
The clinical outcome of both the 3D and standard miniplate systems in the present study was similar; however, the following advantages with the use of 3D miniplates can be highlighted:Relatively lesser operating time.Three-dimensional stability of the fracture site and simultaneous stabilization at superior and inferior borders in the fixation of mandibular fractures.",2019,A statistically significant difference was found in the duration of surgery which was less in group A as compared to group B ( p = 0.03).,"['Anterior Mandibular Fractures', 'anterior mandibular fractures', '20 patients']",['standard titanium miniplates'],['duration of surgery'],"[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0024692', 'cui_str': 'Mandibular Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",20.0,0.0848763,A statistically significant difference was found in the duration of surgery which was less in group A as compared to group B ( p = 0.03).,"[{'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': '1Department of Oral and Maxillofacial Surgery, Sri Hasanamba Dental College and Hospital, Hassan, Karnataka 573201 India.'}, {'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Kerur', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Inderprastha Dental College and Hospital, Sahibabad, Ghaziabad, Uttar Pradesh 201010 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-018-1091-6']
1328,30996548,Comparative Study Between Oral Lorazepam and Diazepam as Sedation in Oral and Maxillofacial Surgery.,"Purpose
The aim of the study was to compare the efficacy of oral lorazepam as night sedation and premedication with diazepam.
Methods
A prospective, randomized, and double-blind study was done in 50 healthy patients in each drug group. The impacted third molar impaction was taken as the study model. Study was carried out after giving bioequivalent doses of respective drugs for either side. All the patients were assessed for quality of sleep, sedation, recall of visual stimuli, cooperation shown by patient and recovery postoperatively.
Results
The study concluded that lorazepam showed more advantages than diazepam as well as patient's preference and satisfaction. However, postoperative recovery with lorazepam was longer than diazepam.",2019,"However, postoperative recovery with lorazepam was longer than diazepam.",['50 healthy patients in each drug group'],"['diazepam', 'lorazepam', 'Lorazepam and Diazepam']","['quality of sleep, sedation, recall of visual stimuli, cooperation shown by patient and recovery postoperatively', 'postoperative recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",50.0,0.030056,"However, postoperative recovery with lorazepam was longer than diazepam.","[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': '1Oral and Maxillofacial Surgery, National Dental College, Derabassi, Punjab India.'}, {'ForeName': 'Amaninder', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': '1Oral and Maxillofacial Surgery, National Dental College, Derabassi, Punjab India.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': '1Oral and Maxillofacial Surgery, National Dental College, Derabassi, Punjab India.'}, {'ForeName': 'Simranjeet', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Conservative and Endodontics, National Dental College and Hospital, Derabassi, Punjab India.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Zutshi', 'Affiliation': '1Oral and Maxillofacial Surgery, National Dental College, Derabassi, Punjab India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-018-1096-1']
1329,31502387,Immediate effect of horse riding simulator on adductor spasticity in children with cerebral palsy: A randomized controlled trial.,"BACKGROUND
Spastic cerebral palsy (CP) is the most common type of CP. Hip adductor spasticity leads to discomfort, stiffness, and difficulties in doing physical activities such as sitting, transfer, and walking. Management of hip adductor spasticity is still a challenge in the field of rehabilitation. Horse riding simulator (HRS) has been reported to have beneficial effects on spasticity, postural control, and motor function in children with spastic CP.
OBJECTIVE
The aim of the study was to determine the immediate effect of HRS on adductor spasticity in children with CP.
METHODS
Twenty-four children with CP were selected and were divided into two groups: experimental and control (12 children in each group). Experimental group was exposed to HRS and control group to the corner seat placement. Adductor tone and passive hip abduction range of motion were measured before and after the intervention.
RESULTS
Post intervention scores in the group of HRS show significant reduction in adductor spasticity and improvement in hip abduction range of motion, whereas no difference have been reported in the control group. HRS has positive effects on reducing spasticity and improving range of motion in hip joint in spastic CP.
CONCLUSION
It was concluded that immediate effect of HRS is successful in reducing the adductor spasticity and improving abduction range of motion in hip, which could be incorporated with regular physiotherapy intervention.",2020,"It was concluded that immediate effect of HRS is successful in reducing the adductor spasticity and improving abduction range of motion in hip, which could be incorporated with regular physiotherapy intervention.","['children with CP', 'children with spastic CP', 'Spastic cerebral palsy (CP', 'children with cerebral palsy', 'Twenty-four children with CP']","['HRS', 'Horse riding simulator (HRS', 'horse riding simulator']","['adductor spasticity and improving abduction range of motion in hip', 'hip abduction range of motion', 'adductor spasticity', 'Adductor tone and passive hip abduction range of motion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0242616', 'cui_str': 'Equidae'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]",24.0,0.0314659,"It was concluded that immediate effect of HRS is successful in reducing the adductor spasticity and improving abduction range of motion in hip, which could be incorporated with regular physiotherapy intervention.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hemachithra', 'Affiliation': 'Division of PM&R, RMMC&H, Annamalai University, Annamalai Nagar, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Meena', 'Affiliation': 'Division of PM&R, RMMC&H, Annamalai University, Annamalai Nagar, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Pediatrics, RMMC&H, Annamalai University, Annamalai Nagar, India.'}, {'ForeName': 'A J W', 'Initials': 'AJW', 'LastName': 'Felix', 'Affiliation': 'Community Medicine, RMMC, Annamalai University, Annamalai Nagar, India.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1809']
1330,30998125,"Effects of short-term sprint interval and moderate-intensity continuous training on liver fat content, lipoprotein profile, and substrate uptake: a randomized trial.","Type 2 diabetes (T2D) and increased liver fat content (LFC) alter lipoprotein profile and composition and impair liver substrate uptake. Exercise training mitigates T2D and reduces LFC, but the benefits of different training intensities in terms of lipoprotein classes and liver substrate uptake are unclear. The aim of this study was to evaluate the effects of moderate-intensity continuous training (MICT) or sprint interval training (SIT) on LFC, liver substrate uptake, and lipoprotein profile in subjects with normoglycemia or prediabetes/T2D. We randomized 54 subjects (normoglycemic group, n = 28; group with prediabetes/T2D, n = 26; age = 40-55 yr) to perform either MICT or SIT for 2 wk and measured LFC with magnetic resonance spectroscopy, lipoprotein composition with NMR, and liver glucose uptake (GU) and fatty acid uptake (FAU) using PET. At baseline, the group with prediabetes/T2D had higher LFC, impaired lipoprotein profile, and lower whole body insulin sensitivity and aerobic capacity compared with the normoglycemic group. Both training modes improved aerobic capacity ( P < 0.001) and lipoprotein profile (reduced LDL and increased large HDL subclasses; all P < 0.05) with no training regimen (SIT vs. MICT) or group effect (normoglycemia vs. prediabetes/T2D). LFC tended to be reduced in the group with prediabetes/T2D compared with the normoglycemic group posttraining ( P = 0.051). When subjects were divided according to LFC (high LFC, >5.6%; low LFC, <5.6%), training reduced LFC in subjects with high LFC ( P = 0.009), and only MICT increased insulin-stimulated liver GU ( P = 0.03). Short-term SIT and MICT are effective in reducing LFC in subjects with fatty liver and in improving lipoprotein profile regardless of baseline glucose tolerance. Short-term MICT is more efficient in improving liver insulin sensitivity compared with SIT. NEW & NOTEWORTHY In the short term, both sprint interval training and moderate-intensity continuous training (MICT) reduce liver fat content and improve lipoprotein profile; however, MICT seems to be preferable in improving liver insulin sensitivity.",2019,Both training modes improved aerobic capacity ( P < 0.001) and lipoprotein profile (reduced LDL and increased large HDL subclasses; all P < 0.05) with no training regimen (SIT vs. MICT) or group effect (normoglycemia vs. prediabetes/T2D).,"['54 subjects (normoglycemic group, n = 28; group with prediabetes/T2D, n = 26; age\u2009=\u200940-55 yr', 'subjects with normoglycemia or prediabetes']","['short-term sprint interval and moderate-intensity continuous training', 'sprint interval training and moderate-intensity continuous training (MICT', 'moderate-intensity continuous training (MICT) or sprint interval training (SIT', 'MICT or SIT']","['Type 2 diabetes (T2D) and increased liver fat content (LFC) alter lipoprotein profile and composition and impair liver substrate uptake', 'LFC, liver substrate uptake, and lipoprotein profile', 'lipoprotein composition with NMR, and liver glucose uptake (GU) and fatty acid uptake (FAU', 'LFC', 'aerobic capacity', 'liver insulin sensitivity', 'lipoprotein profile (reduced LDL and increased large HDL subclasses', 'MICT increased insulin-stimulated liver GU', 'liver fat content, lipoprotein profile, and substrate uptake', 'higher LFC, impaired lipoprotein profile, and lower whole body insulin sensitivity and aerobic capacity']","[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}]",54.0,0.0301251,Both training modes improved aerobic capacity ( P < 0.001) and lipoprotein profile (reduced LDL and increased large HDL subclasses; all P < 0.05) with no training regimen (SIT vs. MICT) or group effect (normoglycemia vs. prediabetes/T2D).,"[{'ForeName': 'Kumail K', 'Initials': 'KK', 'LastName': 'Motiani', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Savolainen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Toivanen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Jari-Joonas', 'Initials': 'JJ', 'LastName': 'Eskelinen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Yli-Karjanmaa', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Kirsi A', 'Initials': 'KA', 'LastName': 'Virtanen', 'Affiliation': 'Turku PET Centre, Turku University Hospital , Turku , Finland.'}, {'ForeName': 'Virva', 'Initials': 'V', 'LastName': 'Saunavaara', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Heiskanen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Parkkola', 'Affiliation': 'Department of Radiology, Turku University Hospital , Turku , Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Haaparanta-Solin', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Solin', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Savisto', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku , Turku , Finland.'}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Knuuti', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Nuutila', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Kari K', 'Initials': 'KK', 'LastName': 'Kalliokoski', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Jarna C', 'Initials': 'JC', 'LastName': 'Hannukainen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00900.2018']
1331,30993478,Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC) in Men Who have Sex with Men with a History of Childhood Sexual Abuse: A Randomized Controlled Trial.,"To address childhood sexual abuse (CSA) related distress and HIV risk in men who have sex with men (MSM) using cognitive-behavioral therapy for trauma and self-care (CBT-TSC), which is a novel intervention integrating HIV risk reduction with modified cognitive and behavioral therapy strategies for post-traumatic stress. We compared CBT-TSC to HIV voluntary counseling and testing (VCT)-only in an initial 2-arm RCT in 43 HIV-negative MSM at with a history of CSA and HIV risk. Serodiscordant condomless anal/vaginal sex (CAS; CAS with HIV-postive or HIV unknown status partners) and posttraumatic stress disorder (PTSD) symptoms (Davidson Trauma Scale: total score and avoidance, intrusions, hyperarousal subscales) were outcomes immediately post-treatment, and at 6- and 9-month follow-up. At post-treatment, CBT-TSC had decreased odds (approximately 60%) of any CAS and greater reductions in CAS compared to VCT-only. Additionally, the CBT-TSC condition experienced greater reductions in total PTSD and avoidance symptoms. At the follow-up visits, CBT-TSC condition had significant reductions in the odds of any CAS and reductions in CAS. However, for PTSD symptoms, only the avoidance subscale remained significantly different compared to VCT-only. CBT-TSC is a potentially efficacious approach to address HIV risk in MSM with a CSA history, with replication and extension in a larger trial needed. This proof-of-concept trial is the first to integrate the treatment of a commonly occurring mental-health syndemic problem in MSM with a health psychology approach to self-care in MSM.Trial Registration Clinicaltrials.gov NCT01266122.",2019,"At post-treatment, CBT-TSC had decreased odds (approximately 60%) of any CAS and greater reductions in CAS compared to VCT-only.","['Who have Sex with Men with a History of Childhood Sexual Abuse', 'men who have sex with men (MSM) using cognitive-behavioral therapy for trauma and self-care (CBT-TSC', 'Men']","['CBT-TSC', 'Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC']","['CAS', 'posttraumatic stress disorder (PTSD) symptoms (Davidson Trauma Scale: total score and avoidance, intrusions, hyperarousal subscales', 'avoidance subscale', 'total PTSD and avoidance symptoms']","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4280883', 'cui_str': 'History of childhood sexual abuse'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}]",,0.0225121,"At post-treatment, CBT-TSC had decreased odds (approximately 60%) of any CAS and greater reductions in CAS compared to VCT-only.","[{'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 7th Floor, Boston, MA, 02114, USA. cocleirigh@mgh.harvard.edu.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'The Fenway Institute of Fenway Health, Boston, MA, USA.'}, {'ForeName': 'S Wade', 'Initials': 'SW', 'LastName': 'Taylor', 'Affiliation': 'The Fenway Institute of Fenway Health, Boston, MA, USA.'}, {'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'Goshe', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 7th Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'C Andres', 'Initials': 'CA', 'LastName': 'Bedoya', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 7th Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Marquez', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 7th Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Boroughs', 'Affiliation': 'Department of Psychology, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Jillian C', 'Initials': 'JC', 'LastName': 'Shipherd', 'Affiliation': 'VA Boston Healthcare System, Boston, MA, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02482-z']
1332,31721026,"Effects of Metformin on Left Ventricular Size and Function in Hypertensive Patients with Type 2 Diabetes Mellitus: Results of a Randomized, Controlled, Multicenter, Phase IV Trial.","BACKGROUND
Metformin is the most widely used oral antihyperglycemic agent for patients with type 2 diabetes mellitus (T2DM). Despite the possible benefits of metformin on diabetes mellitus (DM) and heart failure (HF), acute or unstable HF remains a precaution for its use.
OBJECTIVE
The aim of the present prospective randomized controlled trial was to assess whether metformin treatment has beneficial effects on patients with T2DM with hypertension without overt HF.
METHODS
A total of 164 patients (92 males, 72 females; median age 66 years) were included in this study. Patients with T2DM with a history of hypertension were randomized 1:1 to treatment for 1 year with either metformin (metformin-treated group) or other hypoglycemic agents (control group). The primary endpoints were changes in brain natriuretic peptide (BNP) levels, left ventricular (LV) mass index, and indicators of LV diastolic function. We also evaluated changes in both clinical findings and blood laboratory examination data.
RESULTS
We observed no significant changes between baseline and 1-year post-treatment in LV mass index, BNP levels, or E/e' (early diastolic transmitral flow velocity/early diastolic mitral annular velocity; an indicator of LV diastolic function) in either the metformin-treated (n = 83) or the control (n = 81) groups. The metformin-treated group had a significant reduction of body mass index (BMI) and low-density lipoprotein cholesterol (LDL-C), but the control group did not. We determined that renal function, including serum creatinine and estimated glomerular filtration rate, deteriorated significantly in the control group but not in the metformin-treated group.
CONCLUSION
LV mass and diastolic function were not affected after 1 year of metformin treatment in patients with T2DM. However, we observed benefits in terms of reductions in both BMI and LDL-C levels and preservation of renal function.
TRIAL REGISTRATION
UMIN000006504. Registered 7 October 2011.",2020,"We observed no significant changes between baseline and 1-year post-treatment in LV mass index, BNP levels, or E/e' (early diastolic transmitral flow velocity/early diastolic mitral annular velocity; an indicator of LV diastolic function) in either the metformin-treated (n = 83) or the control (n = 81) groups.","['patients with T2DM with hypertension without overt HF.\nMETHODS\n\n\nA total of 164 patients (92 males, 72 females; median age 66\xa0years', 'Patients with T2DM with a history of hypertension', 'patients with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'Hypertensive Patients with Type 2 Diabetes Mellitus']","['metformin (metformin-treated group) or other hypoglycemic agents (control group', 'metformin', 'Metformin']","[""LV mass index, BNP levels, or E/e' (early diastolic transmitral flow velocity/early diastolic mitral annular velocity; an indicator of LV diastolic function"", 'body mass index (BMI) and low-density lipoprotein cholesterol (LDL-C', 'LV mass and diastolic function', 'changes in brain natriuretic peptide (BNP) levels, left ventricular (LV) mass index, and indicators of LV diastolic function', 'renal function, including serum creatinine and estimated glomerular filtration rate', 'Left Ventricular Size and Function', 'diabetes mellitus (DM) and heart failure (HF', 'BMI and LDL-C levels and preservation of renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C3811844'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",164.0,0.0466242,"We observed no significant changes between baseline and 1-year post-treatment in LV mass index, BNP levels, or E/e' (early diastolic transmitral flow velocity/early diastolic mitral annular velocity; an indicator of LV diastolic function) in either the metformin-treated (n = 83) or the control (n = 81) groups.","[{'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Ono', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan. kohono@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Wada', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Satoh-Asahara', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Hitoki', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiology, National Hospital Organization Hokkaido Cancer Center, 2-3-54, Kikusuishijyo, Shiraishi-ku, Sapporo, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Uehara', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Tochigi Medical Center, 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi, 3208580, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Funada', 'Affiliation': 'Department of Cardiology, National Hospital Organization Ehime Medical Center, 366 Yokogawara, Toon, Ehime, 791-0281, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ogo', 'Affiliation': 'Department of Metabolism and Endocrinology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Horie', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Department of Cardiovascular Medicine, Uji Hospital, Uji, Kyoto, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimatsu', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-019-00381-1']
1333,31721053,Tinzaparin Sodium Pharmacokinetics in Patients with Chronic Kidney Disease: Practical Implications.,"Low-molecular-weight heparins (LMWHs) are the mainstay of the prophylaxis and treatment of venous thromboembolism (VTE). Due to their renal elimination, the risk of accumulation with the related bleeding risk may represent a limitation for the use of LMWHs in patients with chronic kidney disease (CKD) as the risk of major bleeding is increased in patients with creatinine clearance (CrCl) < 30 mL/min, especially in patients with cancer. LMWH structure and molecular weight (MW) are heterogeneous among available agents. The elimination of tinzaparin, which has the highest mean MW among LMWHs, is less dependent on renal function as it is also metabolized through the reticuloendothelial system. A subcutaneous therapeutic dose of tinzaparin (175 IU/kg) once daily has been shown to cause no accumulation of anti-factor Xa activity in patients with CrCl ≥ 20 mL/min. Clinical experience from randomized controlled studies has shown no significant impact of CKD on bleeding risk in cancer patients receiving treatment doses of tinzaparin. This suggests that in these patients the use of treatment doses of tinzaparin does not require anticoagulation monitoring or dose adjustment.",2020,"The elimination of tinzaparin, which has the highest mean MW among LMWHs, is less dependent on renal function as it is also metabolized through the reticuloendothelial system.","['patients with chronic kidney disease (CKD', 'patients with creatinine clearance (CrCl) ', 'Patients with Chronic Kidney Disease', 'patients with CrCl ≥', 'patients with cancer', 'cancer patients receiving treatment doses of']","['Tinzaparin Sodium Pharmacokinetics', 'CKD', 'tinzaparin', 'Low-molecular-weight heparins (LMWHs']","['LMWH structure and molecular weight (MW', 'bleeding risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0354599', 'cui_str': 'Tinzaparin sodium'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0216278', 'cui_str': 'tinzaparin'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0136101,"The elimination of tinzaparin, which has the highest mean MW among LMWHs, is less dependent on renal function as it is also metabolized through the reticuloendothelial system.","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Helfer', 'Affiliation': 'Hôpital Louis-Mourier, Service de Médecine Interne (APHP), Université Paris Diderot, Université de Paris, Colombes, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Siguret', 'Affiliation': ""Service d'Hématologie biologique, Hôpital Lariboisière (APHP), Paris, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mahé', 'Affiliation': 'Hôpital Louis-Mourier, Service de Médecine Interne (APHP), Université Paris Diderot, Université de Paris, Colombes, France. isabelle.mahe@aphp.fr.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-019-00382-0']
1334,25392618,Comparing the da Vinci si single console and dual console in teaching novice surgeons suturing techniques.,"BACKGROUND AND OBJECTIVES
Robot-assisted laparoscopic surgery is often taught with the surgical mentor at the surgeon console and the trainee at the patient's bedside. The da Vinci dual console (Intuitive Surgical, Sunnyvale, California) allows a surgical mentor to teach with both the mentor and the trainee working at a surgeon console simultaneously. The purpose of this study is to evaluate the effectiveness of the dual console versus the single console for teaching medical students robotic tasks.
METHODS
Forty novice medical students were randomized to either the da Vinci single-console or dual-console group and were taught 4 knot-tying techniques by a surgical mentor. The students were timed while performing the tasks.
RESULTS
No statistically significant differences in mean task times were observed between the single- and dual-console groups: interrupted stitch with a 2-handed knot (300 seconds for single vs 294 seconds for dual, P=.59), interrupted stitch with a 1-handed knot (198 seconds for single vs 212 seconds for dual, P=.88), figure-of-8 stitch with a 2-handed knot (261 seconds for single vs 219 seconds for dual, P=.20), and figure-of-8 stitch with a 1-handed knot (200 seconds for single vs 199 seconds for dual, P=.53).
CONCLUSION
No significant difference was observed in performance time when teaching knot-tying techniques to medical students using the da Vinci dual console compared with the single console. More research needs to be performed on the utility of the da Vinci dual console in surgical training.",2014,No significant difference was observed in performance time when teaching knot-tying techniques to medical students using the da Vinci dual console compared with the single console.,['Forty novice medical students'],"['Robot-assisted laparoscopic surgery', 'da Vinci single-console or dual-console group and were taught 4 knot-tying techniques by a surgical mentor', 'interrupted stitch with a 1-handed knot']","['mean task times', 'performance time']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3873699', 'cui_str': 'Console'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0230497,No significant difference was observed in performance time when teaching knot-tying techniques to medical students using the da Vinci dual console compared with the single console.,"[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Crusco', 'Affiliation': 'College of Medicine, University of Central Florida, Orlando, FL, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Jackson', 'Affiliation': 'Florida Hospital Celebration Health, Celebration, FL, USA.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Advincula', 'Affiliation': 'Florida Hospital Celebration Health, Celebration, FL, USA.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
1335,31628507,Effects of the monoamine stabilizer (-)OSU6162 on cognitive function in alcohol dependence.,"INTRODUCTION
Alcohol dependence (AD) is associated with a dysregulated mesolimbocortical dopamine system-a pathway which is also implicated in both reward and cognition. The monoamine stabilizer (-)-OSU6162 (OSU) is a novel pharmacological compound with the ability to reduce ethanol intake and ethanol seeking in long-term drinking rats as well as reducing alcohol craving in AD patients. Dopaminergic drugs can both impair and improve cognitive functions, and the aim of the current study was to investigate the effect of OSU treatment on cognitive functioning in AD patients.
METHOD
In a randomized double-blind placebo-controlled study, 56 individuals with AD received 14 days of OSU or placebo treatment. Neuropsychological tasks from the Cambridge Automated Neuropsychological Test Battery (CANTAB®) and other tasks were used to evaluate treatment effect on executive function/impulsivity, working memory, attention, emotional recognition, and divergent thinking.
RESULTS
Treatment with OSU did not impair neuropsychological function in any of the cognitive domains investigated (all p > 0.1). In fact, OSU treatment did, compared to placebo, improve future planning ability (F (1,46) = 6.9; p = 0.012; Cohen's d = 0.54), verbal divergent thinking (F (1,44) = 10.1; p = 0.003; d = 0.96), and response time for emotional recognition (F (1,47) = 6.7; p = 0.013; d = 0.44).
CONCLUSION
OSU treatment did not cause short-term cognitive side effects, further supporting the potential of OSU as a clinically feasible pharmacological treatment in AD patients. OSU treatment might improve future planning, verbal divergent thinking, and emotional recognition latency, which in turn may have a beneficial impact on alcohol use outcomes. Future studies are needed to confirm these preliminary findings.",2020,"RESULTS
Treatment with OSU did not impair neuropsychological function in any of the cognitive domains investigated (all p > 0.1).","['AD patients', '56 individuals with AD received 14\xa0days of', 'alcohol dependence']","['OSU', 'placebo', 'OSU or placebo', 'monoamine stabilizer (-)OSU6162', 'monoamine stabilizer (-)-OSU6162 (OSU']","['executive function/impulsivity, working memory, attention, emotional recognition, and divergent thinking', 'future planning ability', 'response time for emotional recognition', 'alcohol craving', 'cognitive functioning', 'neuropsychological function', 'cognitive functions', 'verbal divergent thinking']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0966482', 'cui_str': '(-)-OSU6162'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}]",56.0,0.075321,"RESULTS
Treatment with OSU did not impair neuropsychological function in any of the cognitive domains investigated (all p > 0.1).","[{'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Khemiri', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden. lotfi.khemiri@ki.se.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Steensland', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Guterstam', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Örjan', 'Initials': 'Ö', 'LastName': 'de Manzano', 'Affiliation': 'Department of Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Franck', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Jayaram-Lindström', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}]",Psychopharmacology,['10.1007/s00213-019-05345-6']
1336,30985861,Assessment of Inpatient Time Allocation Among First-Year Internal Medicine Residents Using Time-Motion Observations.,"Importance
The United States spends more than $12 billion annually on graduate medical education. Understanding how residents balance patient care and educational activities may provide insights into how the modern physician workforce is being trained.
Objective
To describe how first-year internal medicine residents (interns) allocate time while working on general medicine inpatient services.
Design, Setting, and Participants
Direct observational secondary analysis, including 6 US university-affiliated and community-based internal medicine programs in the mid-Atlantic region, of the Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, a cluster-randomized trial comparing different duty-hour policies. A total of 194 weekday shifts were observed and time motion data were collected, sampled by daytime, nighttime, and call shifts in proportion to the distribution of shifts within each program from March 10 through May 31, 2016. Data were analyzed from June 1, 2016, through January 5, 2019.
Main Outcomes and Measures
Mean time spent in direct and indirect patient care, education, rounds, handoffs, and miscellaneous activities within a 24-hour period and in each of four 6-hour periods (morning, afternoon, evening, and night). Time spent multitasking, simultaneously engaged in combinations of direct patient care, indirect patient care, or education, and in subcategories of indirect patient care were tracked.
Results
A total of 80 interns (55% men; mean [SD] age, 28.7 [2.3] years) were observed across 194 shifts, totaling 2173 hours. A mean (SD) of 15.9 (0.7) hours of a 24-hour period (66%) was spent in indirect patient care, mostly interactions with the patient's medical record or documentation (mean [SD], 10.3 [0.7] hours; 43%). A mean (SD) of 3.0 (0.1) hours was spent in direct patient care (13%) and 1.8 (0.3) hours in education (7%). This pattern was consistent across the 4 periods of the day. Direct patient care and education frequently occurred when interns were performing indirect patient care. Multitasking with 2 or more indirect patient care activities occurred for a mean (SD) of 3.8 (0.4) hours (16%) of the day.
Conclusions and Relevance
This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities. These findings provide an essential baseline measure for future efforts designed to improve the workday structure and experience of internal medicine trainees, without making a judgment on the current allocation of time.
Trial Registration
ClinicalTrials.gov identifier: NCT02274818.",2019,"This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities.","['Participants\n\n\nDirect observational secondary analysis, including 6 US university-affiliated and community-based internal medicine programs in the mid-Atlantic region', 'A total of 80 interns (55% men; mean [SD] age, 28.7 [2.3] years) were observed across 194 shifts, totaling 2173 hours']",[],"['indirect patient care activities', 'time motion data', 'Measures\n\n\nMean time spent in direct and indirect patient care, education, rounds, handoffs, and miscellaneous activities within a 24-hour period and in each of four 6-hour periods (morning, afternoon, evening, and night', 'Time spent multitasking, simultaneously engaged in combinations of direct patient care, indirect patient care, or education, and in subcategories of indirect patient care']","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026053', 'cui_str': 'Middle Atlantic States'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]",[],"[{'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0017313'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]",,0.0475539,"This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities.","[{'ForeName': 'Krisda H', 'Initials': 'KH', 'LastName': 'Chaiyachati', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Manqing', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Bellini', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'C Jessica', 'Initials': 'CJ', 'LastName': 'Dine', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Sternberg', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Yevgeniy', 'Initials': 'Y', 'LastName': 'Gitelman', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Yeager', 'Affiliation': 'Department of Medicine, Yale-New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Asch', 'Affiliation': 'Department of Emergency Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sanjay V', 'Initials': 'SV', 'LastName': 'Desai', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0095']
1337,30292847,Comparing Two Imaging Methods for Follow-Up of Lung Cancer Treatment: A Randomized Pilot Study.,"BACKGROUND
Scientific data on the image modality to be used in postcurative treatment surveillance of non-small cell lung cancer patients are scarce. This prospective randomized pilot trial compared the performance of integrated 18 F-fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) and contrast-enhanced computed tomography (CE-CT).
METHODS
After termination of curative-intent treatment, patients were randomly assigned to the PET-CT or the CE-CT group. Imaging was performed every 6 months for 2 years. If suspicious radiologic findings were detected or patients became symptomatic, a diagnostic workup was initiated. Sensitivity, specificity, and positive predictive value for detecting cancer recurrence were calculated for both imaging procedures.
RESULTS
The study enrolled 96 patients. In 14 of 50 patients (28%) in the PET-CT group and in 14 of 46 patients (30%) in the CE-CT group, a suspicious radiologic finding was confirmed as cancer recurrence after diagnostic workup. False-positive findings were detected in 11 patients (22%) of the PET-CT group and in 8 patients (17%) of the CE-CT group. The sensitivity, specificity, and positive predictive value for detecting cancer recurrence (95% confidence interval) were 0.88 (0.62 to 0.98), 0.62 (0.42 to 0.79), and 0.56 (0.35 to 0.76) for PET-CT and 0.93 (0.68 to 1.00), 0.72 (0.53 to 0.87), and 0.64 (0.41to 0.83) for CE-CT, respectively.
CONCLUSIONS
The results of our study suggest that PET-CT is not superior to CE-CT in detecting cancer recurrence during 2 years after curative-intent treatment of non-small cell lung cancer.",2019,"The sensitivity, specificity, and positive predictive value for detecting cancer recurrence (95% confidence interval) were 0.88 (0.62 to 0.98), 0.62 (0.42 to 0.79), and 0.56 (0.35 to 0.76) for PET-CT and 0.93 (0.68 to 1.00), 0.72 (0.53 to 0.87), and 0.64 (0.41to 0.83) for CE-CT, respectively.
","['non-small cell lung cancer patients', 'enrolled 96 patients']","['CE-CT', 'PET-CT', 'integrated 18 F-fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) and contrast-enhanced computed tomography (CE-CT', 'PET-CT or the CE-CT']","['sensitivity, specificity, and positive predictive value for detecting cancer recurrence', 'Sensitivity, specificity, and positive predictive value for detecting cancer recurrence', 'cancer recurrence', 'False-positive findings']","[{'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}]",96.0,0.0815965,"The sensitivity, specificity, and positive predictive value for detecting cancer recurrence (95% confidence interval) were 0.88 (0.62 to 0.98), 0.62 (0.42 to 0.79), and 0.56 (0.35 to 0.76) for PET-CT and 0.93 (0.68 to 1.00), 0.72 (0.53 to 0.87), and 0.64 (0.41to 0.83) for CE-CT, respectively.
","[{'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Gambazzi', 'Affiliation': 'Clinic of Thoracic Surgery, Cantonal Hospital Aarau, Aarau, Switzerland. Electronic address: franco.gambazzi@ksa.ch.'}, {'ForeName': 'Lukas D', 'Initials': 'LD', 'LastName': 'Frey', 'Affiliation': 'Institute of Nuclear Medicine and PET-Center, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bruehlmeier', 'Affiliation': 'Institute of Nuclear Medicine and PET-Center, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Janthur', 'Affiliation': 'Clinic of Oncology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Sereina M', 'Initials': 'SM', 'LastName': 'Graber', 'Affiliation': 'Anthropological Institute and Museum, University of Zurich-Irchel, Zurich, Switzerland.'}, {'ForeName': 'Juerg', 'Initials': 'J', 'LastName': 'Heuberger', 'Affiliation': 'Clinic of Radio-Oncology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Oliver S', 'Initials': 'OS', 'LastName': 'Springer', 'Affiliation': 'Department of Radiology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zweifel', 'Affiliation': 'Institute of Pathology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Boerner', 'Affiliation': 'Clinic of Pulmonary and Sleep Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Gabrielo M', 'Initials': 'GM', 'LastName': 'Tini', 'Affiliation': 'Clinic of Pulmonary and Sleep Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Sarosh', 'Initials': 'S', 'LastName': 'Irani', 'Affiliation': 'Clinic of Pulmonary and Sleep Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2018.08.015']
1338,30938914,Effect of cryoballoon and radiofrequency ablation for pulmonary vein isolation on left atrial function in patients with nonvalvular paroxysmal atrial fibrillation: A prospective randomized study (Cryo-LAEF study).,"BACKGROUND
Isolation of the pulmonary veins (PVI) has become a mainstay in atrial fibrillation (AFib) therapy. Lesions in left atrial tissue lead to scar formation and this may affect left atrial function.
METHODS
Patients with paroxysmal AFib were randomly assigned in a 1:2 allocation scheme to radiofrequency (RF) ablation or cryoballoon. Real-time three-dimensional echocardiography was performed (under sinus rhythm in all cases) before ablation and at 1 and 3 months to evaluate the left atrial functional indices. The primary outcome measure was change in left atrial ejection fraction (LAEF) at 1 month.
RESULTS
120 patients were randomized (80 to cryoballoon, 40 to RF). The absolute change in LAEF at 1 month was 4.0 (Q1-Q3, -0.1to 7.6)% in the cryoballoon group and -0.8 (Q1-Q3, -1.9 to 0.9)% in the RF group (P < 0.001 for the comparison between groups). At 3 months, the corresponding changes were 6.7 (Q1-Q3, 3.4-11.2)% and 0.7 (Q1-Q3, -0.7 to 3.5)%, respectively (P < 0.001). Overall, the rate of patients with lower LAEF at 3 months compared to baseline was 2.5% in the cryoballoon group and 32.5% in the RF group (P < 0.001). AFib recurrence rate at 6 months was higher in patients with decreased LAEF (odds ratio, 6.2; 95% confidence interval, 2.0-19.5; P = 0.002).
CONCLUSION
The Cryo-LAEF study prospectively compared the effects of RF and cryoballoon ablation on left atrial function. Both at 1 and 3 months postablation, LAEF was either improved or stable in both ablation groups.",2019,"AFib recurrence rate at 6 months was higher in patients with decreased LAEF (odds ratio, 6.2; 95% confidence interval, 2.0-19.5; P = 0.002).
","['patients with nonvalvular paroxysmal atrial fibrillation', '120 patients', 'Patients with paroxysmal AFib']","['RF and cryoballoon ablation', 'cryoballoon and radiofrequency ablation', 'radiofrequency (RF) ablation or cryoballoon']","['rate of patients with lower LAEF', 'AFib recurrence rate', 'absolute change in LAEF', 'change in left atrial ejection fraction (LAEF', 'left atrial function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0078995', 'cui_str': 'Atrial Function, Left'}]",120.0,0.058323,"AFib recurrence rate at 6 months was higher in patients with decreased LAEF (odds ratio, 6.2; 95% confidence interval, 2.0-19.5; P = 0.002).
","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giannopoulos', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Kossyvakis', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Vrachatis', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Constadina', 'Initials': 'C', 'LastName': 'Aggeli', 'Affiliation': '1st Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsitsinakis', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Letsas', 'Affiliation': '2nd Department of Cardiology, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tsiachris', 'Affiliation': 'Athens Heart Center, Athens Medical Center, Marousi, Greece.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Tsoukala', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Efremidis', 'Affiliation': '2nd Department of Cardiology, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Dimosthenis', 'Initials': 'D', 'LastName': 'Katritsis', 'Affiliation': '2nd Department of Cardiology, Hygeia Hospital, Marousi, Greece.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Deftereos', 'Affiliation': '1st Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13933']
1339,30987939,"Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial.","BACKGROUND
In the interim analyses of the LATITUDE study, the addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) led to a significant improvement in overall survival and radiographic progression-free survival compared with placebos plus ADT in men with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (mCSPC). Here, we present long-term survival outcomes and safety of abiraterone acetate plus prednisone and ADT from the final analysis of the LATITUDE study.
METHODS
This is a multicentre, randomised, double-blind, phase 3 trial done at 235 sites in 34 countries. Eligible patients (men aged ≥18 years) had newly diagnosed, histologically or cytologically confirmed prostate cancer with metastases, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and at least two of the three high-risk prognostic factors (Gleason score of ≥8, presence of three or more lesions on bone scan, or presence of measurable visceral metastasis except lymph node metastasis). Patients were randomly assigned (1:1) to receive abiraterone acetate (1000 mg) once daily orally plus prednisone (5 mg) once daily orally and ADT (abiraterone acetate plus prednisone group) or matching placebos plus ADT (placebo group); each treatment cycle was 28 days. Randomisation was done by a centralised interactive web response system in a country-by-country scheme using permuted block randomisation, stratified by presence of visceral disease and ECOG performance status. The coprimary endpoint of overall survival was assessed in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT01715285 and is complete.
FINDINGS
Between Feb 12, 2013, and Dec 11, 2014, 1209 patients were screened, of whom ten were ineligible because of study site violations. 1199 patients were randomly assigned to either the abiraterone acetate plus prednisone group (n=597) or placebo group (n=602). After the results of the first interim analysis (cutoff date Oct 31, 2016), the study was unmasked to patients and investigators, and patients in the placebo group were allowed to cross over to receive abiraterone acetate and prednisone plus ADT treatment as per a protocol amendment (Feb 15, 2017) in an open-label extension phase of the study (up to 18 months from the protocol amendment). This final analysis (data cutoff Aug 15, 2018) was done after a median follow-up of 51·8 months (IQR 47·2-57·0) and 618 deaths (275 [46%] of 597 in the abiraterone acetate plus prednisone group and 343 [57%] of 602 in the placebo group). Overall survival was significantly longer in the abiraterone acetate plus prednisone group (median 53·3 months [95% CI 48·2-not reached]) than in the placebo group (36·5 months [33·5-40·0]), with a hazard ratio of 0·66 (95% CI 0·56-0·78; p<0·0001). The most common grade 3-4 adverse events were hypertension (125 [21%] in the abiraterone acetate plus prednisone group vs 60 [10%] in the placebo group vs three [4%] in the 72 patients who crossed over from placebo to abiraterone acetate plus prednisone) and hypokalaemia (70 [12%] vs ten [2%] vs two [3%]). Serious adverse events of any grade occurred in 192 (32%) of 597 patients in the abiraterone acetate plus prednisone group, 151 (25%) of 602 in the placebo group, and four (6%) of 72 in the crossover group. The most common treatment-related serious adverse event was hypokalaemia (four [1%] patients in the abiraterone acetate plus prednisone group and none in the other groups). Treatment-related deaths occurred in three (<1%) patients each in the abiraterone acetate plus prednisone group (gastric ulcer perforation, sudden death, and cerebrovascular accident) and the placebo group (sudden death, cerebrovascular accident, and pneumonia), with none in the crossover group.
INTERPRETATION
The combination of abiraterone acetate plus prednisone with ADT was associated with significantly longer overall survival than placebos plus ADT in men with newly diagnosed high-risk mCSPC and had a manageable safety profile. These findings support the use of abiraterone acetate plus prednisone as a standard of care in patients with high-risk mCSPC.
FUNDING
Janssen Research & Development.",2019,"Overall survival was significantly longer in the abiraterone acetate plus prednisone group (median 53·3 months [95% CI 48·2-not reached]) than in the placebo group (36·5 months [33·5-40·0]), with a hazard ratio of 0·66 (95% CI 0·56-0·78; p<0·0001).","['men with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (mCSPC', 'men with newly diagnosed high-risk mCSPC', '235 sites in 34 countries', 'patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE', 'Eligible patients (men aged ≥18 years) had newly diagnosed, histologically or cytologically confirmed prostate cancer with metastases, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and at least two of the three high-risk prognostic factors (Gleason score of ≥8, presence of three or more lesions on bone scan, or presence of measurable visceral metastasis except lymph node metastasis', 'Between Feb 12, 2013, and Dec 11, 2014, 1209 patients were screened, of whom ten were ineligible because of study site violations', 'patients with high-risk mCSPC', '1199 patients']","['placebos plus ADT', 'placebo to abiraterone acetate plus prednisone', 'abiraterone acetate plus prednisone', 'prednisone (5 mg) once daily orally and ADT (abiraterone acetate plus prednisone group) or matching placebos plus ADT (placebo', 'placebo', 'abiraterone acetate plus prednisone with ADT', 'abiraterone acetate and prednisone plus ADT', 'abiraterone acetate', 'abiraterone acetate plus prednisone and ADT', 'Abiraterone acetate plus prednisone', 'abiraterone acetate plus prednisone to androgen deprivation therapy (ADT']","['hypokalaemia', 'Overall survival', 'sudden death, cerebrovascular accident, and pneumonia', 'gastric ulcer perforation, sudden death, and cerebrovascular accident', 'overall survival and radiographic progression-free survival', 'deaths', 'overall survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0341163', 'cui_str': 'Gastric ulcer with perforation'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1199.0,0.662238,"Overall survival was significantly longer in the abiraterone acetate plus prednisone group (median 53·3 months [95% CI 48·2-not reached]) than in the placebo group (36·5 months [33·5-40·0]), with a hazard ratio of 0·66 (95% CI 0·56-0·78; p<0·0001).","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.'}, {'ForeName': 'NamPhuong', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Janssen Research and Development, Los Angeles, CA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Fein', 'Affiliation': 'Instituto de Oncologia de Rosário, Rosário, Argentina.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Rodriguez-Antolin', 'Affiliation': '12 de Octubre University Hospital, Madrid, Spain.'}, {'ForeName': 'Boris Y', 'Initials': 'BY', 'LastName': 'Alekseev', 'Affiliation': 'PA Hertsen Moscow Cancer Research Institute, Moscow, Russia.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Cerrahpaşa Medical Faculty, Istanbul University Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Studienpraxis Urologie, Nürtingen, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Protheroe', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Giri', 'Initials': 'G', 'LastName': 'Sulur', 'Affiliation': 'Janssen Research and Development, Los Angeles, CA, USA.'}, {'ForeName': 'Yesenia', 'Initials': 'Y', 'LastName': 'Luna', 'Affiliation': 'Janssen Research and Development, Los Angeles, CA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Mundle', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer Agency-Vancouver Centre, Vancouver, BC, Canada.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30082-8']
1340,30392112,"A supportive care intervention for people with metastatic melanoma being treated with immunotherapy: a pilot study assessing feasibility, perceived benefit, and acceptability.","INTRODUCTION
Increasing numbers of metastatic melanoma (MM) patients are receiving immunotherapy treatment, including pembrolizumab, and the impact on their well-being is underexplored.
OBJECTIVES
To assess the feasibility of a multimodal supportive care program to MM patients being treated with pembrolizumab.
METHODS
This pre-post-test feasibility cohort study recruited MM participants treated with pembrolizumab: (i) supportive care intervention with usual care and (ii) usual care. The intervention comprised comprehensive medical assessment by supportive care physician (SCP), exercise physiologist (EP), and dietitian then a tailored supportive care program. Programs included exercise, dietary advice, non-invasive complementary therapies, and psychology consultation. Outcome measures included adherence, patient-reported symptoms, anxiety and depression, and toxicity. Descriptive data are reported.
RESULTS
We recruited 28 participants: 13 intervention and 15 control; three did not complete the study. Most were male, with median age 66 (range 42-85) years. All intervention participants completed baseline assessments with SCP, EP, and dietitian. Two missed follow-up with EP or dietitian. Symptoms most troubling at baseline were as follows: fatigue (n = 6), sleep (n = 6), general aches and pains (n = 5), and memory (n = 4). All intervention participants were prescribed 16 exercise sessions; 8 (50%) completed all; overall exercise adherence was 85%. Integrative therapies were accessed by 85% (11) participants. Immunotherapy-related adverse event rates were low and SCP consultation identified symptoms not captured by CTCAE 4.0.
CONCLUSIONS
A holistic supportive care intervention tailored to individual needs is feasible. The symptom burden in MM patients was low. Further investigation of the intervention is warranted, focused on populations with higher symptom burden to improve outcomes.",2019,"Symptoms most troubling at baseline were as follows: fatigue (n = 6), sleep (n = 6), general aches and pains (n = 5), and memory (n = 4).","['MM patients being treated with pembrolizumab', 'people with metastatic melanoma being treated with', 'Most were male, with median age 66 (range 42-85) years', '28 participants: 13 intervention and 15 control; three did not complete the study']","['pembrolizumab: (i) supportive care intervention with usual care and (ii) usual care', 'immunotherapy', 'exercise, dietary advice, non-invasive complementary therapies, and psychology consultation', 'supportive care intervention', 'comprehensive medical assessment by supportive care physician (SCP), exercise physiologist (EP), and dietitian then a tailored supportive care program', 'multimodal supportive care program']","['general aches and pains', 'overall exercise adherence', 'adherence, patient-reported symptoms, anxiety and depression, and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0936077', 'cui_str': 'Complementary therapy (regime/therapy)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0260141', 'cui_str': 'Physiologist (occupation)'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",28.0,0.10366,"Symptoms most troubling at baseline were as follows: fatigue (n = 6), sleep (n = 6), general aches and pains (n = 5), and memory (n = 4).","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Lacey', 'Affiliation': ""Chris O'Brien Lifehouse Comprehensive Cancer Centre, Missenden Rd, Camperdown, NSW, Australia. Judith.Lacey@lh.org.au.""}, {'ForeName': 'Anna J', 'Initials': 'AJ', 'LastName': 'Lomax', 'Affiliation': ""Chris O'Brien Lifehouse Comprehensive Cancer Centre, Missenden Rd, Camperdown, NSW, Australia.""}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse Comprehensive Cancer Centre, Missenden Rd, Camperdown, NSW, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marthick', 'Affiliation': ""Chris O'Brien Lifehouse Comprehensive Cancer Centre, Missenden Rd, Camperdown, NSW, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': ""Chris O'Brien Lifehouse Comprehensive Cancer Centre, Missenden Rd, Camperdown, NSW, Australia.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kao', 'Affiliation': ""Chris O'Brien Lifehouse Comprehensive Cancer Centre, Missenden Rd, Camperdown, NSW, Australia.""}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Nielsen', 'Affiliation': ""Chris O'Brien Lifehouse Comprehensive Cancer Centre, Missenden Rd, Camperdown, NSW, Australia.""}, {'ForeName': 'Haryana M', 'Initials': 'HM', 'LastName': 'Dhillon', 'Affiliation': 'Centre for Medical Psychology and Evidence-Based Decision-Making, School of Psychology, University of Sydney, Sydney, NSW, Australia.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4524-3']
1341,30987844,Re: Effect of Adding Docetaxel to Androgen-Deprivation Therapy in Patients with High-risk Prostate Cancer with Rising Prostate-specific Antigen Levels After Primary Local Therapy A Randomized Clinical Trial.,,2019,,['Patients with High-risk Prostate Cancer with Rising Prostate-specific Antigen Levels'],['Docetaxel to Androgen-Deprivation Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]",[],,0.0676478,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kretschmer', 'Affiliation': 'Department of Urology, University Hospital Munich, Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Tilki', 'Affiliation': 'Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. Electronic address: dtilki@me.com.'}]",European urology,['10.1016/j.eururo.2019.03.031']
1342,31948661,Insulin Resistance Modifies the Effects of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction (from the OMEGA-REMODEL Randomized Clinical Trial).,"Insulin resistance early after acute myocardial infarction is associated with increased heart failure and mortality. OMEGA-REMODEL was a prospective double-blind 1:1 randomized control trial of patients with AMI. We reported that 6-month treatment with omega-3 fatty acid (O-3FA) 4 g/day attenuated cardiac remodeling accompanied by reduction in inflammation. We hypothesized that insulin resistance modifies the therapeutic effect of O-3FA on post-MI cardiac remodeling. The OMEGA-REMODEL study group was dichotomized according to cohort- and gender-specific median cutoff value of leptin-to-adiponectin ratio (LAR) at baseline (LAR-Hi vs LAR-Lo). Mixed model regression analyses were used to evaluate effect modification of O-3FA on reduction of left ventricular end-systolic volume index (LVESVI) by LAR status. Baseline LAR was evaluated on 325 patients (59 ± 11 years, 81% male). A total of 168 patients were categorized in LAR-Lo, and 157 in LAR-Hi. O-3FA treatment resulted in significant LVESVI reduction in patients with LAR-Lo but not with LAR-Hi (p = 0.0002 vs 0.66, respectively). Mixed model regression analysis showed significant modification of LAR on O-3FA's treatment effect in attenuating LVESVI (p = 0.021). In conclusion, this post-hoc efficacy analysis suggests that LAR status significantly modified O-3FA's treatment effect in attenuating cardiac remodeling. During the convalescent phase of acute infarct healing, patients with lower insulin resistance estimated by LAR appear to derive more therapeutic response from O-3FA toward improvement of LVESVI.",2020,"O-3FA treatment resulted in significant LVESVI reduction in patients with LAR-Lo but not with LAR-Hi (p = 0.0002 vs 0.66, respectively).","['patients with AMI', '325 patients (59 ± 11 years, 81% male', '168 patients were categorized in LAR-Lo, and 157 in LAR-Hi']","['omega-3 fatty acid (O-3FA', 'O-3FA', 'Omega-3 Acid Ethyl Esters']","['reduction of left ventricular end-systolic volume index (LVESVI', 'heart failure and mortality', 'LVESVI reduction', 'Left Ventricular Remodeling', 'leptin-to-adiponectin ratio (LAR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517714', 'cui_str': 'Three hundred and twenty-five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1532673', 'cui_str': 'Omega-3 Acid Ethyl Esters (USP)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",325.0,0.0365851,"O-3FA treatment resulted in significant LVESVI reduction in patients with LAR-Lo but not with LAR-Hi (p = 0.0002 vs 0.66, respectively).","[{'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Fujikura', 'Affiliation': 'Advanced Cardiovascular Imaging Laboratory, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Bobak', 'Initials': 'B', 'LastName': 'Heydari', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': ""Noninvasive Cardiovascular Imaging Section, Department of Radiology and Cardiovascular Division of the Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Kaneko', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Showa University Hospital, Tokyo, Japan.'}, {'ForeName': 'Shuaib', 'Initials': 'S', 'LastName': 'Abdullah', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harris', 'Affiliation': 'Department of Internal Medicine, Sanford School of Medicine, University of South Dakota, Sioux Falls, South Dakota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jerosch-Herold', 'Affiliation': ""Noninvasive Cardiovascular Imaging Section, Department of Radiology and Cardiovascular Division of the Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""Noninvasive Cardiovascular Imaging Section, Department of Radiology and Cardiovascular Division of the Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: rykwong@bwh.harvard.org.""}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.032']
1343,31000477,"Safety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial.","BACKGROUND
HIV-1-specific broadly neutralising antibodies such as VRC01 could promote HIV remission by halting viral replication and clearing infected cells. We investigated whether VRC01 could promote sustained viral control off antiretroviral therapy (ART) in adults who initiated ART during acute HIV infection.
METHODS
We did a randomised, double-blind, placebo-controlled trial at the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. Eligible participants were aged 20-50 years, had initiated ART during acute infection (ie, Fiebig stages I-III), had been taking ART for more than 24 months, had fewer than 50 HIV-1 RNA copies per mL on three consecutive measurements, had more than 400 CD4 cells per μL, had fewer than ten copies of integrated HIV-1 DNA per 10 6 peripheral blood mononuclear cells, and were in generally good health. Eligible participants were randomly assigned (3:1) based on computer-generated lists with a blocking factor of 4 to receive VRC01 (40 mg/kg) or placebo (saline) intravenously every 3 weeks for up to 24 weeks during analytic interruption of ART, followed by continued observation off all therapies. Randomisation was stratified by Fiebig stage (I vs II vs III) at HIV diagnosis. Participants were monitored closely and resumed ART if 1000 or more HIV-1 RNA copies were detected per mL of plasma. The primary outcomes were the frequency of serious adverse events and the proportion of participants with fewer than 50 HIV-1 RNA copies per mL 24 weeks after treatment interruption. Efficacy analyses included all participants who received at least one full dose of study product, and safety analyses included all participants exposed to any study product. The trial was registered with ClinicalTrials.gov, number NCT02664415. This trial is completed.
FINDINGS
Between Aug 8, 2016, and Jan 9, 2017, 19 men were randomly assigned, 14 to the VRC01 group and five to the placebo group. One participant in the VRC01 group received a partial infusion without undergoing treatment interruption. The other 18 participants all received at least one full study infusion and underwent ART interruption. No serious adverse events were reported in either group. Only one participant in the VRC01 group achieved the primary efficacy endpoint of viral suppression 24 weeks after ART interruption. The other 17 restarted ART because of a confirmed recording of 1000 or more HIV-1 RNA copies per mL before 24 weeks.
INTERPRETATION
VRC01 monotherapy in individuals who initiated ART during acute HIV infection was well tolerated but did not significantly increase the number of participants with viral suppression 24 weeks after ART interruption. Further development of VRC01 and other immunotherapies for HIV will probably occur as part of combination regimens that include several treatments directed against unique therapeutic targets.
FUNDING
US Department of the Army, US National Institutes of Health, and the Thai Red Cross AIDS Research Centre.",2019,No serious adverse events were reported in either group.,"['adults who initiated ART during acute HIV infection', 'Thai Red Cross AIDS Research Centre in Bangkok, Thailand', 'adults with acutely treated HIV (RV397', 'Eligible participants were aged 20-50 years, had initiated ART during acute infection (ie, Fiebig stages I-III), had been taking ART for more than 24 months, had fewer than 50 HIV-1', 'participants who received at least one full dose of study product, and safety analyses included all participants exposed to any study product', 'Between Aug 8, 2016, and Jan 9, 2017, 19 men', 'Eligible participants', '18 participants all received at least one full study infusion and underwent ART interruption']","['VRC01', 'placebo', 'placebo (saline', 'computer-generated lists with a blocking factor of 4 to receive VRC01', 'partial infusion without undergoing treatment interruption', 'antiretroviral therapy (ART']","['serious adverse events', 'frequency of serious adverse events', 'Safety and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0343752', 'cui_str': 'Acute human immunodeficiency virus seroconversion illness'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0034907', 'cui_str': 'Red Crescent'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0275518', 'cui_str': 'Acute infectious disease (disorder)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0053851', 'cui_str': 'blocking factor'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",19.0,0.746782,No serious adverse events were reported in either group.,"[{'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Crowell', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. Electronic address: tcrowell@hivresearch.org.'}, {'ForeName': 'Donn J', 'Initials': 'DJ', 'LastName': 'Colby', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Suteeraporn', 'Initials': 'S', 'LastName': 'Pinyakorn', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Sacdalan', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Pagliuzza', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Jintana', 'Initials': 'J', 'LastName': 'Intasan', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Khunthalee', 'Initials': 'K', 'LastName': 'Benjapornpong', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Kamonkan', 'Initials': 'K', 'LastName': 'Tangnaree', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Nitiya', 'Initials': 'N', 'LastName': 'Chomchey', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Eugène', 'Initials': 'E', 'LastName': 'Kroon', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'de Souza', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Sodsai', 'Initials': 'S', 'LastName': 'Tovanabutra', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Rolland', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Eller', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Paquin-Proulx', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Bolton', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Tokarev', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Rasmi', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takata', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Trautmann', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Shelly J', 'Initials': 'SJ', 'LastName': 'Krebs', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Adrian B', 'Initials': 'AB', 'LastName': 'McDermott', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Doria-Rose', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bijal', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gorelick', 'Affiliation': 'AIDS and Cancer Virus Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.'}, {'ForeName': 'Brandie A', 'Initials': 'BA', 'LastName': 'Fullmer', 'Affiliation': 'AIDS and Cancer Virus Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schuetz', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Pornsuk V', 'Initials': 'PV', 'LastName': 'Grandin', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': ""O'Connell"", 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Tressler', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Chomont', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Nittaya', 'Initials': 'N', 'LastName': 'Phanuphak', 'Affiliation': 'SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Jintanat', 'Initials': 'J', 'LastName': 'Ananworanich', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; SEARCH, the Thai Red Cross AIDS Research Center, Bangkok, Thailand; Department of Global Health, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30053-0']
1344,30945297,Effect of pomegranate seed oil supplementation on the GLUT-4 gene expression and glycemic control in obese people with type 2 diabetes: A randomized controlled clinical trial.,"Abnormality in glucose transporter type 4 (GLUT-4) function and insulin secretion are the main causes of type 2 diabetes mellitus (T2DM). Due to adverse effects of antidiabetic drugs, nowadays, nutraceuticals have been of much interest to investigators. The aim of the present study was to determine the effect of pomegranate seed oil (PSO) on the GLUT-4 gene expression and glycemic control in obese people with T2DM. This randomized clinical trial was conducted on 52 obese type 2 diabetic patients for 8 weeks in Tabriz, Iran, in 2018. Patients were divided into the intervention group (n = 26; who consumed daily three capsules containing 1 g PSO) and the placebo group (n = 26; the same amounts paraffin). GLUT-4 gene expression and glycemic indices were evaluated by standard methods. GLUT-4 gene expression was increased significantly in the PSO group. Within-group changes in fasting blood sugar (FBS) and quantitative insulin sensitivity check index were significant in the PSO group. After adjusting the age, gender, and baseline values, FBS was significantly decreased. Insulin concentration, HbA1C, HOMA-IR, and HOMA-β did not manifest significant changes. PSO increased the GLUT-4 gene expression in diabetic patients without any side effects. However, future clinical studies are needed to confirm the obtained results.",2019,"Insulin concentration, HbA1C, HOMA-IR, and HOMA-β did not manifest significant changes.","['52 obese type 2 diabetic patients for 8 weeks in Tabriz, Iran, in 2018', 'obese people with T2DM', 'obese people with type 2 diabetes', 'diabetic patients']","['pomegranate seed oil supplementation', 'placebo', 'consumed daily three capsules containing 1\u2009g PSO', 'pomegranate seed oil (PSO', 'PSO']","['quantitative insulin sensitivity check index', 'fasting blood sugar (FBS', 'GLUT-4 gene expression and glycemic indices', 'GLUT-4 gene expression', 'Insulin concentration, HbA1C, HOMA-IR, and HOMA-β', 'GLUT-4 gene expression and glycemic control']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3256645', 'cui_str': 'POMEGRANATE SEED OIL'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",52.0,0.0660053,"Insulin concentration, HbA1C, HOMA-IR, and HOMA-β did not manifest significant changes.","[{'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Khajebishak', 'Affiliation': 'Talented Student Center, Student Research Committee, Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Payahoo', 'Affiliation': 'Department of Nutrition, Maragheh University of Medical Sciences, Maragheh, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Alivand', 'Affiliation': 'Department of Medical Genetics, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Hamishehkar', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Endocrinology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Vahide', 'Initials': 'V', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Department of Nutrition, Maragheh University of Medical Sciences, Maragheh, Iran.'}, {'ForeName': 'Mahdiye', 'Initials': 'M', 'LastName': 'Alipour', 'Affiliation': 'Dental and Periodontal Research Center, Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Beitollah', 'Initials': 'B', 'LastName': 'Alipour', 'Affiliation': 'Department of Community Nutrition, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of cellular physiology,['10.1002/jcp.28561']
1345,30975627,"Erlotinib plus bevacizumab versus erlotinib alone in patients with EGFR-positive advanced non-squamous non-small-cell lung cancer (NEJ026): interim analysis of an open-label, randomised, multicentre, phase 3 trial.","BACKGROUND
Resistance to first-generation or second-generation EGFR tyrosine kinase inhibitor (TKI) monotherapy develops in almost half of patients with EGFR-positive non-small-cell lung cancer (NSCLC) after 1 year of treatment. The JO25567 phase 2 trial comparing erlotinib plus bevacizumab combination therapy with erlotinib monotherapy established the activity and manageable toxicity of erlotinib plus bevacizumab in patients with NSCLC. We did a phase 3 trial to validate the results of the JO25567 study and report here the results from the preplanned interim analysis.
METHODS
In this prespecified interim analysis of the randomised, open-label, phase 3 NEJ026 trial, we recruited patients with stage IIIB-IV disease or recurrent, cytologically or histologically confirmed non-squamous NSCLC with activating EGFR genomic aberrations from 69 centres across Japan. Eligible patients were at least 20 years old, and had an Eastern Cooperative Oncology Group performance status of 2 or lower, no previous chemotherapy for advanced disease, and one or more measurable lesions based on Response Evaluation Criteria in Solid Tumours (1.1). Patients were randomly assigned (1:1) to receive oral erlotinib 150 mg per day plus intravenous bevacizumab 15 mg/kg once every 21 days, or erlotinib 150 mg per day monotherapy. Randomisation was done by minimisation, stratified by sex, smoking status, clinical stage, and EGFR mutation subtype. The primary endpoint was progression-free survival. This study is ongoing; the data cutoff for this prespecified interim analysis was Sept 21, 2017. Efficacy was analysed in the modified intention-to-treat population, which included all randomly assigned patients who received at least one dose of treatment and had at least one response evaluation. Safety was analysed in all patients who received at least one dose of study drug. The trial is registered with the University Hospital Medical Information Network Clinical Trials Registry, number UMIN000017069.
FINDINGS
Between June 3, 2015, and Aug 31, 2016, 228 patients were randomly assigned to receive erlotinib plus bevacizumab (n=114) or erlotinib alone (n=114). 112 patients in each group were evaluable for efficacy, and safety was evaluated in 112 patients in the combination therapy group and 114 in the monotherapy group. Median follow-up was 12·4 months (IQR 7·0-15·7). At the time of interim analysis, median progression-free survival for patients in the erlotinib plus bevacizumab group was 16·9 months (95% CI 14·2-21·0) compared with 13·3 months (11·1-15·3) for patients in the erlotinib group (hazard ratio 0·605, 95% CI 0·417-0·877; p=0·016). 98 (88%) of 112 patients in the erlotinib plus bevacizumab group and 53 (46%) of 114 patients in the erlotinib alone group had grade 3 or worse adverse events. The most common grade 3-4 adverse event was rash (23 [21%] of 112 patients in the erlotinib plus bevacizumab group vs 24 [21%] of 114 patients in the erlotinib alone group). Nine (8%) of 112 patients in the erlotinib plus bevacizumab group and five (4%) of 114 patients in the erlotinib alone group had serious adverse events. The most common serious adverse events were grade 4 neutropenia (two [2%] of 112 patients in the erlotinib plus bevacizumab group) and grade 4 hepatic dysfunction (one [1%] of 112 patients in the erlotinib plus bevacizumab group and one [1%] of 114 patients in the erlotinib alone group). No treatment-related deaths occurred.
INTERPRETATION
The results of this interim analysis showed that bevacizumab plus erlotinib combination therapy improves progression-free survival compared with erlotinib alone in patients with EGFR-positive NSCLC. Future studies with longer follow-up, and overall survival and quality-of-life data will be required to further assess the efficacy of this combination in this setting.
FUNDING
Chugai Pharmaceutical.",2019,The most common grade 3-4 adverse event was rash (23 [21%] of 112 patients in the erlotinib plus bevacizumab group vs 24 [21%] of 114 patients in the erlotinib alone group).,"['patients with stage IIIB-IV disease or recurrent, cytologically or histologically confirmed non-squamous NSCLC with activating EGFR genomic aberrations from 69 centres across Japan', 'patients with EGFR-positive NSCLC', '112 patients in the combination therapy group and 114 in the monotherapy group', 'patients with NSCLC', 'patients with EGFR-positive advanced non-squamous non-small-cell lung cancer (NEJ026', 'Eligible patients were at least 20 years old, and had an Eastern Cooperative Oncology Group performance status of 2 or lower, no previous chemotherapy for advanced disease, and one or more measurable lesions based on Response Evaluation Criteria in Solid Tumours (1.1', 'Between June 3, 2015, and Aug 31, 2016, 228 patients']","['bevacizumab', 'Erlotinib plus bevacizumab', 'erlotinib alone', 'oral erlotinib 150 mg per day plus intravenous bevacizumab', 'erlotinib 150 mg per day monotherapy', 'erlotinib plus bevacizumab', 'bevacizumab plus erlotinib combination therapy']","['Efficacy', 'grade 3 or worse adverse events', 'median progression-free survival', 'serious adverse events', 'progression-free survival', 'grade 4 hepatic dysfunction', 'activity and manageable toxicity', 'efficacy, and safety', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303405', 'cui_str': '114In radioisotope'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517491', 'cui_str': 'One point one'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2978152', 'cui_str': 'erlotinib 150 MG [Tarceva]'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",228.0,0.181871,The most common grade 3-4 adverse event was rash (23 [21%] of 112 patients in the erlotinib plus bevacizumab group vs 24 [21%] of 114 patients in the erlotinib alone group).,"[{'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Furuya', 'Affiliation': 'St Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Shunichiro', 'Initials': 'S', 'LastName': 'Iwasawa', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsunezuka', 'Affiliation': 'Ishikawa Prefectural Central Hospital, Kanazawa, Japan.'}, {'ForeName': 'Ou', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Yoshimori', 'Affiliation': 'Fukujuji Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakachi', 'Affiliation': 'Saiseikai Utsunomiya Hospital, Utsunomiya, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Gemma', 'Affiliation': 'Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Kurume University, Kurume, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Kurimoto', 'Affiliation': 'Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Tsubata', 'Affiliation': 'Shimane University, Shimane, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Nagashima', 'Affiliation': 'Iwate Medical University School of Medicine, Morioka, Japan.'}, {'ForeName': 'Gyo', 'Initials': 'G', 'LastName': 'Asai', 'Affiliation': 'Aichi Cancer Center Aichi Hospital, Okazaki, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Miyazaki', 'Affiliation': 'Suita Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nukiwa', 'Affiliation': 'Tohoku University, Miyagi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Maemondo', 'Affiliation': 'Iwate Medical University School of Medicine, Morioka, Japan. Electronic address: maemondo-ma693@aioros.ocn.ne.jp.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30035-X']
1346,30907035,Effect of acupuncture at Neiguan point combined with amiodarone therapy on early recurrence after pulmonary vein electrical isolation in patients with persistent atrial fibrillation.,"OBJECTIVE
Early atrial fibrillation (AF) recurrences are common and have been shown to predict AF recurrences late after AF ablation during follow-up. Neiguan point acupuncture has been recognized to be therapeutic in treating AF in clinical practice.
METHODS AND RESULTS
Eighty-five patients were enrolled in succession due to persistent AF. All patients were randomized divided into control group and acupuncture group. In the control group (n = 45), amiodarone was orally taken from the first day after pulmonary vein isolation (PVI). In the acupuncture group (n = 40), patients were treated with Neiguan point acupuncture for 7 days and amiodarone was prescribed as same as the control group after PVI. The levels of inflammatory factors were analyzed before operation, 1 week after the operation and 3 months later. After 3 months, the acupuncture group had a lower rate of early recurrences than the control group (5/40 [12.5%] vs 15/45 [33.3%], P = 0.039). The inflammatory factors level in the two groups were significantly increased after ablation. However, compared with the control group, the levels of TNF-α, IL-6, CRP, TGF-β1, MMP2 in the acupuncture group significantly lower (P < 0.05). In a multivariate analysis, acupuncture was an independent factor associated with a lower rate of early recurrences during the blanking period (odds ratio, 0.17; 95% confidence interval, 0.05-0.63; P = 0.008).
CONCLUSION
Neiguan point acupuncture combined with amiodarone is superior to amiodarone alone in reducing early recurrences of patients with persistent AF after PVI. The efficacy of Neiguan acupuncture therapy on the early recurrence is associated with the decreased inflammation factors.",2019,"In a multivariate analysis, acupuncture was an independent factor associated with a lower rate of early recurrences during the blanking period (odds ratio, 0.17; 95% confidence interval, 0.05-0.63; P = 0.008).
","['Eighty-five patients were enrolled in succession due to persistent AF', 'patients with persistent AF after PVI', 'Early atrial fibrillation', 'patients with persistent atrial fibrillation']","['amiodarone', 'Neiguan point acupuncture', 'Neiguan acupuncture therapy', 'acupuncture', 'amiodarone therapy']","['levels of TNF-α, IL-6, CRP, TGF-β1, MMP2', 'inflammatory factors level', 'levels of inflammatory factors', 'rate of early recurrences']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C4303555', 'cui_str': 'Amiodarone therapy (procedure)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",85.0,0.0451316,"In a multivariate analysis, acupuncture was an independent factor associated with a lower rate of early recurrences during the blanking period (odds ratio, 0.17; 95% confidence interval, 0.05-0.63; P = 0.008).
","[{'ForeName': 'Junkui', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Shengbo', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Weihai Municipal Hospital, Weihai, Henan.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, Fuwai Central China Cardiovascular Hospital, Henan Provincial Peoples Hospital, Zhengzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhibing', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Huangfen', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Congxin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13924']
1347,31542243,Sorafenib Versus Observation Following Radical Metastasectomy for Clear-cell Renal Cell Carcinoma: Results from the Phase 2 Randomized Open-label RESORT Study.,"BACKGROUND
In selected metastatic renal cell carcinoma (mRCC) patients, radical metastasectomy followed by observation is a potential strategy. It is still to be defined whether systemic therapy should be administered following metastasectomy.
OBJECTIVE
To assess the potential benefit of postoperative treatment with sorafenib compared with observation alone after radical metastasectomy in mRCC patients.
DESIGN, SETTING, AND PARTICIPANTS
The RESORT trial was a multicenter, randomized, open-label, phase 2 study conducted between November 2012 and November 2017 in Italy. Patients with clear-cell mRCC pretreated with nephrectomy and undergoing radical metastasectomy (three or fewer lesions) were eligible for the study. Patients were randomized (1:1) within 12 wk from metastasectomy to sorafenib (standard dose 400 mg twice daily) or observation for a maximum of 52 wk. Stratification factors were interval from nephrectomy, site, and number of lesions. Overall, 76 patients were screened and 69 were randomized: 33 were assigned to sorafenib and 36 to observation. The primary endpoint was recurrence-free survival (RFS). Secondary endpoints were overall survival and the safety profile.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
RFS curves were estimated with the Kaplan-Meier method, and the log-rank test was used to statistically compare the curves.
RESULTS AND LIMITATIONS
At a median follow-up of 38 mo, median RFS was 37 mo (95% confidence interval [CI] 20-not available [NA]) in the observation arm versus 21 mo (95% CI 11-NA) in the sorafenib arm (log-rank test p = 0.404), with 12-, 24-, and 36-mo RFS probability of 74% versus 63%, 59% versus 49%, and 50% versus 41%, respectively, in the observation versus the sorafenib arm. Any-grade adverse event (AE) rates were 84% in the sorafenib arm and 31% in the observation arm; grade ≥3 AE rates were 22% and 3% in the sorafenib and the observation arm, respectively, with a rate of treatment discontinuation for AEs of 19% in the sorafenib arm.
CONCLUSIONS
This prospective study showed that systemic treatment with sorafenib did not increase RFS as compared with observation in mRCC patients following radical metastasectomy.
PATIENT SUMMARY
This article reports the clinical outcome of patients with metastatic renal cell carcinoma treated with sorafenib or managed with an observation-alone strategy after the radical surgery of metastases. We found that sorafenib did not improve the patient outcome in terms of relapse-free survival in this selected population.",2019,"This prospective study showed that systemic treatment with sorafenib did not increase RFS as compared with observation in mRCC patients following radical metastasectomy.
","['patients with metastatic renal cell carcinoma treated with sorafenib or managed with an observation-alone strategy after the radical surgery of metastases', 'Clear-cell Renal Cell Carcinoma', 'mRCC patients following radical metastasectomy', '76 patients were screened and 69 were randomized: 33 were assigned to', 'selected metastatic renal cell carcinoma (mRCC) patients', 'Patients with clear-cell mRCC pretreated with nephrectomy and undergoing radical metastasectomy (three or fewer lesions) were eligible for the study', 'November 2012 and November 2017 in Italy', 'mRCC patients']","['sorafenib', 'Sorafenib Versus Observation Following Radical Metastasectomy']","['RFS', 'relapse-free survival', 'median RFS', 'Any-grade adverse event (AE) rates', 'RFS probability', 'recurrence-free survival (RFS', 'overall survival and the safety profile', 'grade ≥3\u202fAE rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",76.0,0.256367,"This prospective study showed that systemic treatment with sorafenib did not increase RFS as compared with observation in mRCC patients following radical metastasectomy.
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Procopio', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: giuseppe.procopio@istitutotumori.mi.it.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Apollonio', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cognetti', 'Affiliation': 'Medical Oncology Department, Istituto Nazionale Tumori Regina Elena, Rome, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Department of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Milella', 'Affiliation': 'Medical Oncology Department, Istituto Nazionale Tumori Regina Elena, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Mosca', 'Affiliation': 'Department of Oncology, Maggiore Della Carità University Hospital, Novara, Italy.'}, {'ForeName': 'Vincenzo Emanuele', 'Initials': 'VE', 'LastName': 'Chiuri', 'Affiliation': 'Medical Oncology Department, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bearz', 'Affiliation': 'Medical Oncology Department, National Cancer Institute, Aviano, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Morelli', 'Affiliation': 'Medical Oncology Department, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': 'Medical Oncology Department, Istituto per la Ricerca e la Cura del Cancro di Candiolo, Torino, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Atzori', 'Affiliation': 'Medical Oncology Department, University Hospital, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Donini', 'Affiliation': 'Medical Oncology Department, Ospedale di Cremona, Cremona, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Ratta', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Claps', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Capitanio', 'Affiliation': 'Division of Experimental Oncology, Urological Research Institute, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Filippo G', 'Initials': 'FG', 'LastName': 'de Braud', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Cappelletti', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verzoni', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",European urology oncology,['10.1016/j.euo.2019.08.011']
1348,30948242,Effect of using a wearable device on clinical decision-making and motor symptoms in patients with Parkinson's disease starting transdermal rotigotine patch: A pilot study.,"BACKGROUND
Feedback from wearable biosensors may help assess motor function in Parkinson's disease (PD) patients and titrate medication. Kinesia 360 continuously monitors motor symptoms via wrist and ankle sensors.
METHODS
PD0049 was a 12-week pilot study to investigate whether using Kinesia 360 at home could improve motor symptom management in PD patients starting transdermal dopamine agonist rotigotine. Adults with PD and insufficiently controlled motor symptoms (prescribed rotigotine) were randomized 1:1 to Control Group (CG) or Experimental Group (EG) before starting rotigotine. Motor symptoms were assessed in all patients at baseline and Week 12 (W12) using Unified PD Rating Scale (UPDRS) III and Kinesia ONE, which measures standardized motor tasks via a sensor on the index finger. Between baseline and W12, EG used Kinesia 360 at home; clinicians used the data to supplement standard care in adjusting rotigotine dosage.
RESULTS
At W12, least squares mean improvements in UPDRS II (-2.1 vs 0.5, p = 0.004) and UPDRS III (-5.3 vs -1.0, p = 0.134) were clinically meaningfully greater, and mean rotigotine dosage higher (4.8 vs 3.9 mg/24 h) in EG (n = 19) vs CG (n = 20). Mean rotigotine dosage increase (+2.8 vs + 1.9 mg/24 h) and mean number of dosage changes (2.8 vs 1.8) during the study were higher in EG vs CG. Tolerability and retention rates were similar.
CONCLUSION
Continuous, objective, motor symptom monitoring using a wearable biosensor as an adjunct to standard care may enhance clinical decision-making, and may improve outcomes in PD patients starting rotigotine.",2019,"At W12, least squares mean improvements in UPDRS II (-2.1 vs 0.5, p = 0.004) and UPDRS III (","['Adults with PD and insufficiently controlled motor symptoms (prescribed', ""patients with Parkinson's disease starting transdermal rotigotine patch"", 'PD patients starting', 'PD patients starting rotigotine', ""Parkinson's disease (PD) patients and titrate medication""]","['Control Group (CG) or Experimental Group (EG) before starting rotigotine', 'rotigotine', 'transdermal dopamine agonist rotigotine']","['clinical decision-making and motor symptoms', 'UPDRS II', 'Tolerability and retention rates', 'Motor symptoms', 'motor symptom management', 'UPDRS III ', 'Mean rotigotine dosage increase', 'mean number of dosage changes', 'Unified PD Rating Scale (UPDRS) III and Kinesia ONE']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0178601', 'cui_str': 'Dopaminergic Agonists'}]","[{'cui': 'C4042877', 'cui_str': 'Medical Decision-Making'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}]",,0.0249048,"At W12, least squares mean improvements in UPDRS II (-2.1 vs 0.5, p = 0.004) and UPDRS III (","[{'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center of Boca Raton, Boca Raton, FL, USA. Electronic address: isaacson@ParkinsonsCenter.org.""}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Boroojerdi', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: babak.boroojerdi@ucb.com.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Waln', 'Affiliation': 'Houston Methodist Neurological Institute, Houston, TX, USA. Electronic address: owaln@houstonmethodist.org.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'McGraw', 'Affiliation': 'Central Dupage Hospital/Northwestern Medicine, Winfield, IL, USA. Electronic address: martha.mcgraw@nm.org.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kreitzman', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Long Island, Commack, NY, USA. Electronic address: ParkinsonsCenterLI@gmail.com.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Klos', 'Affiliation': 'Movement Disorder Clinic of Oklahoma, Tulsa, OK, USA. Electronic address: kevin.klos@mdcok.com.'}, {'ForeName': 'Fredy J', 'Initials': 'FJ', 'LastName': 'Revilla', 'Affiliation': 'Greenville Health System, Greenville, SC, USA; Division of Neurology, University of South Carolina School of Medicine Greenville, Greenville, SC, USA. Electronic address: frevilla@ghs.org.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Heldman', 'Affiliation': 'Great Lakes NeuroTechnologies, Cleveland, OH, USA. Electronic address: dheldman@glneurotech.com.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'Great Lakes NeuroTechnologies, Cleveland, OH, USA. Electronic address: maureen.phillips@intel.com.'}, {'ForeName': 'Dolors', 'Initials': 'D', 'LastName': 'Terricabras', 'Affiliation': 'UCB Pharma, Slough, UK. Electronic address: terricabras.dolors@gmail.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Markowitz', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA. Electronic address: michael.markowitz@ucb.com.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Woltering', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: franz.woltering@ucb.com.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Carson', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA. Electronic address: stan.carson@ucb.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Truong', 'Affiliation': ""Parkinson's and Movement Disorder Institute, Fountain Valley, CA, USA. Electronic address: dtruong@pmdi.org.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.01.025']
1349,30955478,The effect of educational text message based on health belief model on osteoporosis preventive behaviors in women: a randomized controlled clinical trial.,"The purpose of this study was to investigate the effect of educational text messages, based on the health belief model, on osteoporosis preventive behaviors among women aged 30-45 years. This trial was conducted on 121 women from November until September 2017 in Shabestar, Iran. The intervention group received a daily educational text message about osteoporosis for one month, and the control group received educational text messages on frequently occurring cancers in women. Two months after the training, data were collected using the osteoporosis health belief scale, a food frequency questionnaire and the International Physical Activity Questionnaire. No significant differences were observed at baseline between the two groups, except for the perceived benefits construct. After the intervention, controlling for baseline score and adjusting for educational level, a statistically significant difference was observed between the two groups in HBM structures and nutrition performance, while no significant difference was observed in physical activity between the two groups. This study showed that educational text messages can be effective in increasing awareness, perceived susceptibility and severity, and nutritional behavior change related to risk of osteoporosis.",2019,"This study showed that educational text messages can be effective in increasing awareness, perceived susceptibility and severity, and nutritional behavior change related to risk of osteoporosis.","['121 women from November until September 2017 in Shabestar, Iran', 'women aged 30-45\xa0years', 'women']","['daily educational text message about osteoporosis for one month, and the control group received educational text messages', 'educational text messages', 'educational text message']","['HBM structures and nutrition performance', 'physical activity', 'osteoporosis health belief scale, a food frequency questionnaire and the International Physical Activity Questionnaire']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0222045'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",121.0,0.0321182,"This study showed that educational text messages can be effective in increasing awareness, perceived susceptibility and severity, and nutritional behavior change related to risk of osteoporosis.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Parandeh', 'Affiliation': ""Department of Midwifery, Students' Research Committee, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Fahimeh Sehhati', 'Initials': 'FS', 'LastName': 'Shafaie', 'Affiliation': 'Nursing and Midwifery Faculty, Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Malakouti', 'Affiliation': 'Nursing and Midwifery Faculty, Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Nursing and Midwifery Faculty, Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Biostatistics, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Women & health,['10.1080/03630242.2019.1590495']
1350,31711874,A pilot study to examine the acceptability and health effects of electronic cigarettes in HIV-positive smokers.,"INTRODUCTION
Some HIV-positive smokers report ambivalence about quitting. Switching to electronic cigarettes (ECs) may be a viable option to reduce the negative health effects for smokers who are unable or unwilling to quit smoking combustible cigarettes (CCs). This study examined the acceptability and health-related effects of ECs in HIV-positive smokers who were not seeking smoking cessation treatment.
METHODS
HIV-positive smokers (N = 19) were enrolled and followed for 12 weeks. Cartridge-based ECs were provided at baseline, and E-liquid was provided weekly for 8 weeks. At baseline, weeks 1-8, and week 12, EC and CC use, cardiopulmonary function, respiratory symptoms, and carbon monoxide (CO) levels were measured.
RESULTS
At week 8, cigarettes per day (CPD) were reduced by more than 80%, with reduction maintained at week 12 (p's < .001). Cigarette dependence scores were 40% lower at week 8 than at baseline (p < .001). Seven (36.8%) participants reported transitioning completely from CCs to ECs. Mean CO decreased significantly from BL to week 8 (p < .05) and remained significantly lower at week 12 (p < .001). Intention to quit increased significantly over time.
CONCLUSIONS
Switching from CCs to ECs in HIV-positive smokers who are not ready to quit smoking in the next 30 days appears to be feasible. Beneficial effects were seen, such as reduced CPD, reduced CO and CC dependence, and increased motivation to quit. ECs may be promising as a harm reduction approach among HIV-positive smokers who are unable or unwilling to quit smoking.",2020,Mean CO decreased significantly from BL to week 8 (p < .05) and remained significantly lower at week 12 (p < .001).,"['smokers who are unable or unwilling to quit smoking combustible cigarettes (CCs', 'HIV-positive smokers who were not seeking smoking cessation treatment', 'HIV-positive smokers (N\u202f=\u202f19) were enrolled and followed for 12 weeks', 'HIV-positive smokers', 'HIV-positive smokers who are unable or unwilling to quit smoking']","['electronic cigarettes (ECs', 'electronic cigarettes', 'ECs']","['Cigarette dependence scores', 'Beneficial effects', 'reduced CPD, reduced CO and CC dependence, and increased motivation to quit', 'cardiopulmonary function, respiratory symptoms, and carbon monoxide (CO) levels', 'Mean CO', 'acceptability and health effects', 'Intention to quit increased significantly over time']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0558080', 'cui_str': 'Unwilling (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0520939', 'cui_str': 'Increased motivation (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0650687,Mean CO decreased significantly from BL to week 8 (p < .05) and remained significantly lower at week 12 (p < .001).,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA. Electronic address: Patricia_Cioe@brown.edu.'}, {'ForeName': 'Alana N', 'Initials': 'AN', 'LastName': 'Mercurio', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lechner', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, OH, USA.'}, {'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Costantino', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Department of Psychology and Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107678']
1351,31058714,Trios-OSCE-based simulation course enhances the subcompetency of emergency-stabilization for postgraduate year-1 residents.,"BACKGROUND
For patient safety, this study aims to evaluate the effectiveness of additional objective structured clinical examination (OSCE)-based medical simulation courses to establish the ""emergency-stabilization"" subcompetency of postgraduate first year (PGY-1) residents.
METHODS
In the simulation course, trainees were randomly divided into three groups: intervention, regular, and control group as Trios-OSCE trainees, Single-OSCE trainees, or OSCE observers (feedback-givers) after attending the pre-OSCE common simulation workshop. Three PGY-1 residents rotated through the Trios OSCE long-station together, while single PGY-1 residents rotated through regular OSCE alone and the control group gave feedback after observation of their peers' OSCE performance. Using Queen's simulation assessment tool, either in Trios-OSCE or Single-OSCE, performance levels were rated as either inferior, novice, competent, advanced or superior in the ""therapeutic actions"" and ""communication"" domains. The ""overall performances"" of all trainees were graded by qualified assessors, experienced facilitators, and standardized senior nurse.
RESULTS
The proportion of ""overall performance"" of trainee's, rated by an experienced facilitator as ""above competent level,"" was significantly higher in intervention group A than in regular group B. After training, the degree of increase in self-efficacy scores was higher among the intervention group than the regular and control groups. In the follow-up stage, a trend of increasing self-efficacy scores was noted in both the interventional and regular groups. For all trainees among the three groups, high postcourse value scores confirm that the new Trios-OSCE model meets the needs of trainees and also motivates the self-directed learning and self-reflection of trainees.
CONCLUSION
Our results provide initial evidence that the new emergency-stabilization-enhanced Trios-OSCE-based medical simulation course including the additional training capacity offered by adding an observer group had positive effects on PGY-1 residents' self-efficacy and clinical transfer.",2019,"In the follow-up stage, a trend of increasing self-efficacy scores was noted in both the interventional and regular groups.","['emergency-stabilization"" subcompetency of postgraduate first year (PGY-1) residents']","['intervention, regular, and control group as Trios-OSCE trainees, Single-OSCE trainees, or OSCE observers (feedback-givers) after attending the pre-OSCE common simulation workshop']",['self-efficacy scores'],"[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",3.0,0.024601,"In the follow-up stage, a trend of increasing self-efficacy scores was noted in both the interventional and regular groups.","[{'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Su', 'Affiliation': 'Department of Medical Education, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Sheng-Wei', 'Initials': 'SW', 'LastName': 'Pan', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ling-Ju', 'Initials': 'LJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Education, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shinn-Jang', 'Initials': 'SJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chiao-Lin', 'Initials': 'CL', 'LastName': 'Chuang', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ching-Chih', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shou-Yen', 'Initials': 'SY', 'LastName': 'Kao', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Fa-Yauh', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000089']
1352,30852136,"Reduced-dose combination chemotherapy (S-1 plus oxaliplatin) versus full-dose monotherapy (S-1) in older vulnerable patients with metastatic colorectal cancer (NORDIC9): a randomised, open-label phase 2 trial.","BACKGROUND
Older or vulnerable patients with metastatic colorectal cancer are seldom included in randomised trials. The multicentre NORDIC9 trial evaluated reduced-dose combination chemotherapy compared with full-dose monotherapy in older, vulnerable patients.
METHODS
This randomised, open-label phase 2 trial was done in 23 Nordic oncology clinics and included patients aged 70 years or older with previously untreated metastatic colorectal cancer who were not candidates for full-dose combination chemotherapy. Patients were block randomised (1:1) using a web-based tool to full-dose S-1 (30 mg/m 2 orally twice daily on days 1-14 every 3 weeks) followed by second-line treatment at progression with irinotecan (250 mg/m 2 intravenously on day 1 every 3 weeks or 180 mg/m 2 intravenously on day 1 every 2 weeks) or reduced-dose combination chemotherapy with S-1 (20 mg/m 2 orally twice daily on days 1-14) and oxaliplatin (100 mg/m 2 intravenously on day 1 every 3 weeks) followed by second-line treatment at progression with S-1 (20 mg/m 2 orally twice daily on days 1-14) and irinotecan (180 mg/m 2 intravenously on day 1 every 3 weeks). Use of bevacizumab (7·5 mg/kg intravenously on day 1 of each cycle) was optional. Treatment allocation was not masked and randomisation was stratified for institution and bevacizumab. The primary outcome was progression-free survival. Survival analyses were by intention to treat and safety analyses were done on the treated population. This trial is registered with EudraCT, number 2014-000394-39, and is closed to new participants.
FINDINGS
From March 9, 2015, to Oct 11, 2017, 160 patients with a median age of 78 years (IQR 76-81) were randomly assigned to full-dose monotherapy (n=83) or reduced-dose combination chemotherapy (n=77). At data cutoff (Sept 1, 2018; median follow-up 23·8 months [IQR 18·8-30·9]), 81 (98%) patients in the full-dose monotherapy group and 71 (92%) patients in the reduced-dose combination group had progressed or died. Median progression-free survival was significantly longer with reduced-dose combination chemotherapy (6·2 months [95% CI 5·3-8·3]) than with full-dose monotherapy (5·3 months [4·1-6·8]; hazard ratio [HR] 0·72 [95% CI 0·52-0·99]; p=0·047). Toxicity was evaluated in 157 patients who received treatment. Significantly more patients in the full-dose monotherapy group (51 [62%] of 82 patients) experienced at least one grade 3-4 adverse event than in the reduced-dose combination group (32 [43%] of 75 patients; p=0·014). Grade 3-4 diarrhoea (12 [15%] vs two [3%]; p=0·018), fatigue (ten [12%] vs three [4%]; p=0·083), and dehydration (five [6%] vs none; p=0·060) were more frequent in the full-dose monotherapy group than in the reduced-dose combination group. Treatment-related deaths occurred in three patients during first-line treatment and three patients during second-line treatment (two in the full-dose monotherapy group vs one in the reduced-dose combination group in both cases).
INTERPRETATION
Reduced-dose combination chemotherapy with S-1 and oxaliplatin for older, vulnerable patients with metastatic colorectal cancer was more effective and resulted in less toxicity than full-dose monotherapy with S-1. Reduced-dose combination chemotherapy could be a preferred treatment for this population.
FUNDING
Taiho Pharmaceuticals, Nordic Group, the Danish Cancer Society, the Swedish Cancer Society, Academy of Geriatric Research (AgeCare), and Region of Southern Denmark.",2019,Median progression-free survival was significantly longer with reduced-dose combination chemotherapy (6·2 months [95% CI 5·3-8·3]) than with full-dose monotherapy (5·3 months [4·1-6·8]; hazard ratio [HR] 0·72,"['older, vulnerable patients', '157 patients who received treatment', 'Older or vulnerable patients with metastatic colorectal cancer', 'older vulnerable patients with metastatic colorectal cancer (NORDIC9', 'older, vulnerable patients with metastatic colorectal cancer', '160 patients with a median age of 78 years', '23 Nordic oncology clinics and included patients aged 70 years or older with previously untreated metastatic colorectal cancer who were not candidates for full-dose combination chemotherapy']","['bevacizumab', 'S-1 and oxaliplatin', 'reduced-dose combination chemotherapy with S-1', 'monotherapy (n=83) or reduced-dose combination chemotherapy', 'full-dose monotherapy (S-1', 'oxaliplatin', 'irinotecan', 'combination chemotherapy', 'combination chemotherapy (S-1 plus oxaliplatin']","['fatigue', 'Grade 3-4 diarrhoea', 'dehydration', 'progressed or died', 'progression-free survival', 'toxicity', 'Toxicity', 'deaths', 'Median progression-free survival']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",160.0,0.341383,Median progression-free survival was significantly longer with reduced-dose combination chemotherapy (6·2 months [95% CI 5·3-8·3]) than with full-dose monotherapy (5·3 months [4·1-6·8]; hazard ratio [HR] 0·72,"[{'ForeName': 'Stine Braendegaard', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Liposits', 'Affiliation': 'Department of Oncology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Halla', 'Initials': 'H', 'LastName': 'Skuladottir', 'Affiliation': 'Department of Oncology, Regional Hospital West Jutland, Herning, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hofsli', 'Affiliation': 'Department of Oncology, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Carl-Henrik', 'Initials': 'CH', 'LastName': 'Shah', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Laurids Østergaard', 'Initials': 'LØ', 'LastName': 'Poulsen', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Ryg', 'Affiliation': 'Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Osterlund', 'Affiliation': 'Department of Oncology, Tampere University Hospital, Tampere University, Tampere, Finland; Department of Oncology, Helsinki University Hospital, Helsinki University, Finland.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Berglund', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Qvortrup', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Halfdan', 'Initials': 'H', 'LastName': 'Sorbye', 'Affiliation': 'Department of Oncology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark. Electronic address: per.pfeiffer@rsyd.dk.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30041-X']
1353,30945798,Effectiveness of single- vs dual-coil implantable defibrillator leads: An observational analysis from the SIMPLE study.,"INTRODUCTION
Dual-coil leads (DC-leads) were the standard of choice since the first nonthoracotomy implantable cardioverter/defibrillator (ICD). We used contemporary data to determine if DC-leads offer any advantage over single-coil leads (SC-leads), in terms of defibrillation efficacy, safety, clinical outcome, and complication rates.
METHODS AND RESULTS
In the Shockless IMPLant Evaluation study, 2500 patients received a first implanted ICD and were randomized to implantation with or without defibrillation testing. Two thousand and four hundred seventy-five patients received SC-coil or DC-coil leads (SC-leads in 1025/2475 patients; 41.4%). In patients who underwent defibrillation testing (n = 1204), patients with both lead types were equally likely to achieve an adequate defibrillation safety margin (88.8% vs 91.2%; P = 0.16). There was no overall effect of lead type on the primary study endpoint of ""failed appropriate shock or arrhythmic death"" (adjusted HR 1.18; 95% CI, 0.86-1.62; P = 0.300), and on all-cause mortality (SC-leads: 5.34%/year; DC-leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94-1.43; P = 0.168). However, among patients without prior heart failure (HF), and SC-leads had a significantly higher risk of failed appropriate shock or arrhythmic death (adjusted HR 7.02; 95% CI, 2.41-20.5). There were no differences in complication rates.
CONCLUSION
In this nonrandomized evaluation, there was no overall difference in defibrillation efficacy, safety, outcome, and complication rates between SC-leads and DC-leads. However, DC-leads were associated with a reduction in the composite of failed appropriate shock or arrhythmic death in the subgroup of non-HF patients. Considering riskier future lead extraction with DC-leads, SC-leads appears to be preferable in the majority of patients.",2019,"There was no overall effect of lead type on the primary study endpoint of ""failed appropriate shock or arrhythmic death"" (adjusted HR 1.18; 95% CI, 0.86-1.62; P = 0.300), and on all-cause mortality (SC-leads: 5.34%/year; DC-leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94-1.43; P = 0.168).","['Two thousand and four hundred seventy-five patients received', '2500 patients received a first implanted ICD']","['single- vs dual-coil implantable defibrillator leads', 'implantation with or without defibrillation testing', 'SC-coil or DC-coil leads (SC-leads']","['complication rates', 'defibrillation efficacy, safety, outcome, and complication rates', 'defibrillation efficacy, safety, clinical outcome, and complication rates', 'arrhythmic death', 'failed appropriate shock or arrhythmic death', 'adequate defibrillation safety margin', 'risk of failed appropriate shock or arrhythmic death']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0181588', 'cui_str': 'Implantable defibrillator leads'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2500.0,0.0913834,"There was no overall effect of lead type on the primary study endpoint of ""failed appropriate shock or arrhythmic death"" (adjusted HR 1.18; 95% CI, 0.86-1.62; P = 0.300), and on all-cause mortality (SC-leads: 5.34%/year; DC-leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94-1.43; P = 0.168).","[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Neuzner', 'Affiliation': 'Klinikum Kassel, Kassel, Germany.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Cardiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Glikson', 'Affiliation': 'Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dietze', 'Affiliation': 'Ambulantes Herzzentrum Kassel, Kassel, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Mabo', 'Affiliation': 'Centre Hospitalier Universitaire, Rennes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vinolas', 'Affiliation': 'Hospital de Santa Creu I Saint Pau, Barcelona, Spain.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Kautzner', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': ""O'Hara"", 'Affiliation': 'Institute Universitaire de Cardiologie et de Pneumologie de, Quebec, QC, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lawo', 'Affiliation': 'Elisabeth Krankenhaus, Recklinghausen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brachmann', 'Affiliation': 'Regiomed Kliniken, Coburg, Germany.'}, {'ForeName': 'Liselot', 'Initials': 'L', 'LastName': 'VanErven', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Gadler', 'Affiliation': 'Karolinska Hospital, Stockholm, Sweden.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Appl', 'Affiliation': 'Boston Scientific, Minneapolis, Minnesota.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Population Health Research Institute, Hamilton, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Mc Master University, Hamilton, Canada.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, Hamilton, Canada.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13943']
1354,30946150,Effects on immune system and viral reservoir of a short-cycle antiretroviral therapy in virologically suppressed HIV-positive patients.,"BACKGROUND
Atripla dose reduction decreases subclinical toxicity and maintains viral suppression in HIV+ individuals but the virological efficacy and immunological safety of this strategy needs to be further confirmed.
METHODS
Virologically suppressed HIV-infected adults on Atripla once-daily were randomized 1 : 1 to reduce therapy to 3 days a week (3W, n = 30) or to maintain it unchanged (once-daily, n = 31). HIV-1 reservoir (total and integrated HIV-1 DNA in CD4 cells) and immunological cell activation (CD38 and HLA-DR), senescence (CD57 and CD28), apoptosis (annexinV) as well as T-naive, effector memory (TEM) (CCR7, CD45RA) and stem cell memory (TSCM) (CD954 and CD27) populations were measured at baseline, 24 and 48 weeks.
RESULTS
No differences on activation, senescence or apoptosis of both CD4 and CD8 T cells were observed on follow-up. Nave CD4 T-cell proportion showed a significant decrease in the 3W group (mean ± SD): 24.6 ± 13.7 vs. 20.5 ± 12.9 (P = 0.002). No differences in both plasma viral load and HIV reservoir were detected on follow-up. CD4 TSCM levels at 48 weeks correlated with basal integrated HIV-1 DNA in the 3W group but not in the once-daily group. A post hoc analysis of data prior to the study entry revealed a higher viral load zenith and a trend to lower CD4 nadir in 3W vs. once-daily group.
CONCLUSION
No significant immunological or viral changes were induced in the 3W group confirming the virological efficacy and immunogical safety of this strategy. In-depth virological and immunological analyses are useful in providing additional information in antiretroviral switching studies (Clinical Trials.gov: NCT01778413).",2019,"No differences on activation, senescence or apoptosis of both CD4 and CD8 T cells were observed on follow-up.","['Virologically suppressed HIV-infected adults on Atripla once-daily', 'virologically suppressed HIV-positive patients', 'HIV+ individuals']",[],"['HIV-1 reservoir (total and integrated HIV-1 DNA in CD4 cells) and immunological cell activation (CD38 and HLA-DR), senescence (CD57 and CD28), apoptosis (annexinV) as well as T-naive, effector memory (TEM) (CCR7, CD45RA) and stem cell memory (TSCM) ', 'Nave CD4 T-cell proportion', 'CD4 TSCM levels', 'immunological or viral changes', 'CD4 nadir', 'plasma viral load and HIV reservoir', 'activation, senescence or apoptosis of both CD4 and CD8 T cells', 'immune system and viral reservoir', 'subclinical toxicity', 'virological efficacy and immunogical safety']","[{'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1724016', 'cui_str': 'Atripla'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0442537', 'cui_str': 'Reservoir (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0231337', 'cui_str': 'Senescence'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C4543203', 'cui_str': 'Effector (disposition)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0020962', 'cui_str': 'Immune system'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.167999,"No differences on activation, senescence or apoptosis of both CD4 and CD8 T cells were observed on follow-up.","[{'ForeName': 'Alberto C', 'Initials': 'AC', 'LastName': 'Guardo', 'Affiliation': ""Laboratory of Retrovirology and Viral Immunopathology, AIDS Research Group, Hospital Clínic- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS).""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Zarama', 'Affiliation': ""Laboratory of Retrovirology and Viral Immunopathology, AIDS Research Group, Hospital Clínic- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS).""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'González', 'Affiliation': ""Laboratory of Retrovirology and Viral Immunopathology, AIDS Research Group, Hospital Clínic- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS).""}, {'ForeName': 'Manel Enric', 'Initials': 'ME', 'LastName': 'Bargalló', 'Affiliation': ""Laboratory of Retrovirology and Viral Immunopathology, AIDS Research Group, Hospital Clínic- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rojas', 'Affiliation': 'Infectious Diseases Unit, Hospital Clínic, IDIBAPS, University of Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Infectious Diseases Unit, Hospital Clínic, IDIBAPS, University of Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Plana', 'Affiliation': ""Laboratory of Retrovirology and Viral Immunopathology, AIDS Research Group, Hospital Clínic- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS).""}, {'ForeName': 'Sonsoles', 'Initials': 'S', 'LastName': 'Sánchez-Palomino', 'Affiliation': ""Laboratory of Retrovirology and Viral Immunopathology, AIDS Research Group, Hospital Clínic- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS).""}]","AIDS (London, England)",['10.1097/QAD.0000000000002169']
1355,30936043,Training gains and transfer effects after mnemonic strategy training in mild cognitive impairment: A fMRI study.,"Prior work has revealed that mnemonic strategy training (MST) can enhance memory for specific content and engages regions in the frontoparietal cognitive control network. Evidence of transfer to novel content is less clear. Here, we provide secondary analysis of functional magnetic resonance imaging (fMRI) data acquired during a randomized controlled trial that compared MST to an active education control condition in patients with amnestic mild cognitive impairment (a-MCI). In the trial, thirty participants with a-MCI were randomized to the education program (EP) or MST, where they learned to apply the technique to face-name associations during four intervening hour long training sessions. Participants underwent pre- and post-training fMRI scans, during which they encoded both the trained (i.e., those used during the four training sessions) and untrained ('novel') face-name associations. The primary cognitive outcome measures revealed significantly improved memory for both trained and novel stimuli - effects supporting near transfer of MST. Relative to pre-training, there were significant and highly similar increases in activation for both trained and novel stimuli, especially in regions associated with the frontoparietal cognitive control network bilaterally, but also in temporal areas related to social cognition and emotional processing. Critically, this pattern of activation was notably different from the EP group. Thus, the changes in activation were consistent with the strategies trained and, combined with the cognitively-based near transfer effects, suggest that MST focused on face-name association enhances performance by engaging cognitive control and social/emotional processing. Finally, our data indicated that our MST is a relevant and efficient intervention to a-MCI.",2019,"Relative to pre-training, there were significant and highly similar increases in activation for both trained and novel stimuli, especially in regions associated with the frontoparietal cognitive control network bilaterally, but also in temporal areas related to social cognition and emotional processing.","['thirty participants with a-MCI', 'patients with amnestic mild cognitive impairment (a-MCI', 'mild cognitive impairment']","['mnemonic strategy training', 'MST', 'education program (EP) or MST', 'mnemonic strategy training (MST']","['memory for both trained and novel stimuli - effects supporting near transfer of MST', 'social cognition and emotional processing']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",30.0,0.0303448,"Relative to pre-training, there were significant and highly similar increases in activation for both trained and novel stimuli, especially in regions associated with the frontoparietal cognitive control network bilaterally, but also in temporal areas related to social cognition and emotional processing.","[{'ForeName': 'Sharon S', 'Initials': 'SS', 'LastName': 'Simon', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil. Electronic address: sharon.sanzsimon@gmail.com.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Hampstead', 'Affiliation': 'Division of Neuropsychology, Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA; VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Mariana P', 'Initials': 'MP', 'LastName': 'Nucci', 'Affiliation': 'Neuroimagem funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Fábio L S', 'Initials': 'FLS', 'LastName': 'Duran', 'Affiliation': 'Laboratory of Psychiatric Neuroimaging (LIM-21), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciana M', 'Initials': 'LM', 'LastName': 'Fonseca', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria da Graça M', 'Initials': 'MDGM', 'LastName': 'Martin', 'Affiliation': 'Neuroimagem funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ávila', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fábio H G', 'Initials': 'FHG', 'LastName': 'Porto', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sônia M D', 'Initials': 'SMD', 'LastName': 'Brucki', 'Affiliation': 'Department of Neurology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Camila B', 'Initials': 'CB', 'LastName': 'Martins', 'Affiliation': 'Department of Preventive Medicine, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lyssandra S', 'Initials': 'LS', 'LastName': 'Tascone', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil; Laboratory of Psychiatric Neuroimaging (LIM-21), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Amaro', 'Affiliation': 'Neuroimagem funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Geraldo F', 'Initials': 'GF', 'LastName': 'Busatto', 'Affiliation': 'Laboratory of Psychiatric Neuroimaging (LIM-21), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cássio M C', 'Initials': 'CMC', 'LastName': 'Bottino', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.03.014']
1356,30948288,"Intravenous vs Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty: A Randomized, Blinded Trial.","BACKGROUND
Multimodal analgesia including acetaminophen is increasingly popular for analgesia after total hip arthroplasty (THA). Intravenous (IV) administration of acetaminophen has pharmacokinetic benefits, but unclear clinical advantages. The authors hypothesized that IV acetaminophen would reduce pain with activity, opioid usage, or opioid-related side effects, compared to oral acetaminophen.
METHODS
In this double-blinded, randomized, controlled trial, 154 THA patients received either IV or oral acetaminophen as part of a comprehensive opioid-sparing multimodal analgesia strategy. Primary outcomes were pain with physical therapy on postoperative day (POD) 1, opioid side effects (POD 1), and cumulative opioid use.
RESULTS
There was no difference in opioid side effects, pain scores, or opioid use between the groups.
CONCLUSION
Patients in both groups had low pain scores, minimal opioid side effects, and limited opioid usage (corresponding to 6 doses of tramadol 100 mg over 3 days). This highlights multimodal analgesia as an effective method of pain control for THA.",2019,"There was no difference in opioid side effects, pain scores, or opioid use between the groups.
","['After Total Hip Arthroplasty', '154 THA patients', 'total hip arthroplasty (THA']","['tramadol', 'comprehensive opioid-sparing multimodal analgesia strategy', 'Intravenous vs Oral Acetaminophen', 'IV or oral acetaminophen', 'acetaminophen']","['pain with physical therapy on postoperative day (POD', 'opioid side effects (POD 1), and cumulative opioid use', 'opioid side effects, pain scores, or opioid use', 'pain with activity, opioid usage, or opioid-related side effects', 'low pain scores, minimal opioid side effects']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]",154.0,0.485813,"There was no difference in opioid side effects, pain scores, or opioid use between the groups.
","[{'ForeName': 'Geoffrey H', 'Initials': 'GH', 'LastName': 'Westrich', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Birch', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Ahava R', 'Initials': 'AR', 'LastName': 'Muskat', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Padgett', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Enrique A', 'Initials': 'EA', 'LastName': 'Goytizolo', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Mathias P', 'Initials': 'MP', 'LastName': 'Bostrom', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mayman', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Jacques T', 'Initials': 'JT', 'LastName': 'YaDeau', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.030']
1357,30885505,"Feasibility and economic assessment of chromocolonoscopy for detection of proximal serrated neoplasia within a population-based colorectal cancer screening programme (CONSCOP): an open-label, randomised controlled non-inferiority trial.","BACKGROUND
Most post-colonoscopy interval colorectal cancers are proximal; serrated polyps are often precursors to these cancers and are considered difficult to detect. We assessed the safety, feasibility, and economic effect of chromocolonoscopy on detection of proximal serrated neoplasia.
METHODS
We did an open-label, multicentre, randomised, controlled non-inferiority trial including patients from Bowel Screening Wales centres. Participants who tested positive for faecal occult blood and who were eligible for and considered fit to have colonoscopy (patients with known cases of polyposis syndromes, Lynch syndrome, and chronic inflammatory disease were excluded) were randomly assigned (1:1; with the use of minimisation, stratified by centre with an 80:20 random element) to either standard white light colonoscopy (standard group) or chromocolonoscopy (indigo carmine dye [0·2%]; chromocolonoscopy group) using a secure, internet-based, computerised, randomisation system that used centralised, dynamic allocation. Participants were followed up for 1 year and data from index colonoscopies and associated clearance procedures were analysed. All proximal polyps were reviewed by an expert pathologist panel. The main outcome on which power was based was time taken to perform the colonoscopy procedure, defined as from the time when the scope was inserted to withdrawal from the anus, assessed in the per-protocol population. The non-inferiority margin was 15 min. This trial is complete and is registered with ClinicalTrials.gov, number NCT01972451.
FINDINGS
Between Nov 20, 2014, and June 16, 2016, 741 (72%) of 1031 patients screened were eligible and consented: 360 were randomly assigned to white light colonoscopy and 381 to chromocolonoscopy. In the chromocolonoscopy group, the procedure took a mean of 36·8 min (SD 15·0), compared with a mean of 30·6 min (13·7) in the standard group (mean difference 6·3 min [95% CI 4·2-8·4] longer with chromocolonoscopy than in the standard group). The mean difference was within the prespecified non-inferiority margin. Detection rates for proximal serrated lesions were significantly higher in the chromocolonoscopy group than in the control group (45 [12%] of 381 patients vs 23 [6%] of 360 patients; odds ratio 1·96 [95% CI 1·16-3·32]; p=0·012). Serious adverse events (four cases of postpolypectomy bleeding [two in each group], and one case of anxiety and hyperventilation [in the chromocolonoscopy group]), colonoscopy quality measures, comfort scores, and sedation were similar between groups.
INTERPRETATION
Chromocolonoscopy is feasible within a population-based colorectal cancer screening programme, is safe, and has significantly increased detection of proximal serrated neoplasia and other polyp types compared with standard colonoscopy. Larger randomised trials of chromocolonoscopy, powered for improved detection of significant serrated polyps and for longer-term follow-up to investigate the effect on reduction of interval cancers within screening populations, are warranted.
FUNDING
Health and Care Research Wales (RfPPB-1021).",2019,Detection rates for proximal serrated lesions were significantly higher in the chromocolonoscopy group than in the control group (45 [12%] of 381 patients vs 23 [6%] of 360 patients; odds ratio 1·96 [95% CI 1·16-3·32]; p=0·012).,"['Between Nov 20, 2014, and June 16, 2016, 741 (72%) of 1031 patients screened were eligible and consented: 360', 'Participants who tested positive for faecal occult blood and who were eligible for and considered fit to have colonoscopy (patients with known cases of polyposis syndromes, Lynch syndrome, and chronic inflammatory disease were excluded', 'patients from Bowel Screening Wales centres']","['white light colonoscopy', 'standard white light colonoscopy (standard group) or chromocolonoscopy (indigo carmine dye [0·2%]; chromocolonoscopy group) using a secure, internet-based, computerised, randomisation system that used centralised, dynamic allocation', 'chromocolonoscopy', 'colorectal cancer screening programme (CONSCOP']","['Serious adverse events', 'Detection rates for proximal serrated lesions', 'colonoscopy quality measures, comfort scores, and sedation', 'safety, feasibility, and economic effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps (morphologic abnormality)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4552100', 'cui_str': 'Lynch Syndrome'}, {'cui': 'C1290886', 'cui_str': 'Chronic inflammatory disorder'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021219', 'cui_str': 'indigotindisulfonate sodium'}, {'cui': 'C0013343', 'cui_str': 'Dyes'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.28329,Detection rates for proximal serrated lesions were significantly higher in the chromocolonoscopy group than in the control group (45 [12%] of 381 patients vs 23 [6%] of 360 patients; odds ratio 1·96 [95% CI 1·16-3·32]; p=0·012).,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hurt', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rajeswari', 'Initials': 'R', 'LastName': 'Ramaraj', 'Affiliation': 'Division of Population Medicine, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Farr', 'Affiliation': 'College of Human and Health Sciences, Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Meleri', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Department of Pathology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Namor', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Department of Pathology, Abertawe Bro Morgannwg University Health Board, Port Talbot, UK.'}, {'ForeName': 'Ceri J', 'Initials': 'CJ', 'LastName': 'Philips', 'Affiliation': 'College of Human and Health Sciences, Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Geraint T', 'Initials': 'GT', 'LastName': 'Williams', 'Affiliation': 'Department of Pathology, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Gardner', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sampson', 'Affiliation': 'Division of Cancer and Genetics, Department of Medical Genetics, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Hillier', 'Affiliation': 'Screening Division, Public Health Wales, Cardiff, UK.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Heard', 'Affiliation': 'Bowel Screening Wales, Public Health Wales, Llantrisant, UK.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Dolwani', 'Affiliation': 'Division of Population Medicine, Cardiff University School of Medicine, Cardiff, UK. Electronic address: dolwanis@cardiff.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30035-4']
1358,30941442,Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS
The aim of this study was to evaluate the effectiveness of perineal massage, pelvic floor muscle training (PFMT) and a pelvic floor dysfunction (PFD) prevention educational program in pregnant women above the age of 35 years to prevent perineal tear and episiotomy.
METHODS
A randomized parallel assignment study involved two groups of pregnant women at the obstetrics outpatient clinic 4 weeks prior to their due date. The first group (n = 200) was educated to do digital perineal massage and pelvic floor muscle training and received an educational PFD prevention program. The second group (n = 200) received only the prevention education program. Occurrence of perineal laceration was reported at time of delivery as a primary outcome. Statistical analysis was done using the IBM SPSS computer program (Statistical Package for the Social Sciences; IBM Corp, Armonk, NY, USA), release 22 for Microsoft Windows.
RESULTS
Delivery was significantly less complicated by perineal tear, episiotomy and postnatal pain in the first than in the second group (p < 0.05). Grades of perineal tear were mostly of first and second degree in the first group compared with the second group. We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively).
CONCLUSIONS
Performing antenatal digital perineal massage and PFMT in addition to health education is recommended to reduce perineal complications.",2020,"We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively).
","['pregnant women above the age of 35 years to prevent perineal tear and episiotomy', 'two groups of pregnant women at the obstetrics outpatient clinic 4\xa0weeks prior to their due date', 'pregnant women older than 35\xa0years']","['prevention education program', 'perineal massage, pelvic floor muscle training (PFMT) and a pelvic floor dysfunction (PFD) prevention educational program', 'digital perineal massage and pelvic floor muscle training and received an educational PFD prevention program', 'Perineal massage and training reduce perineal trauma']","['Grades of perineal tear', 'Occurrence of perineal laceration', 'perineal tear, episiotomy and postnatal pain', 'hospital stay']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C2825543', 'cui_str': 'Estimated date of delivery (observable entity)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction (disorder)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0341226,"We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively).
","[{'ForeName': 'Amira S', 'Initials': 'AS', 'LastName': 'Dieb', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt. amirasaied2026@gmail.com.'}, {'ForeName': 'Amira Y', 'Initials': 'AY', 'LastName': 'Shoab', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Nabil', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Gabr', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Abdallah', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Shaban', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Attia', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}]",International urogynecology journal,['10.1007/s00192-019-03937-6']
1359,30948276,"Gene-expression profiling of bortezomib added to standard chemoimmunotherapy for diffuse large B-cell lymphoma (REMoDL-B): an open-label, randomised, phase 3 trial.","BACKGROUND
Biologically distinct subtypes of diffuse large B-cell lymphoma can be identified using gene-expression analysis to determine their cell of origin, corresponding to germinal centre or activated B cell. We aimed to investigate whether adding bortezomib to standard therapy could improve outcomes in patients with these subtypes.
METHODS
In a randomised evaluation of molecular guided therapy for diffuse large B-cell lymphoma with bortezomib (REMoDL-B), an open-label, adaptive, randomised controlled, phase 3 superiority trial, participants were recruited from 107 cancer centres in the UK (n=94) and Switzerland (n=13). Eligible patients had previously untreated, histologically confirmed diffuse large B-cell lymphoma with sufficient diagnostic material from initial biopsies for gene-expression profiling and pathology review; were aged 18 years or older; had ECOG performance status of 2 or less; had bulky stage I or stage II-IV disease requiring full-course chemotherapy; had measurable disease; and had cardiac, lung, renal, and liver function sufficient to tolerate chemotherapy. Patients initially received one 21-day cycle of standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP; rituximab 375 mg/m 2 , cyclophosphamide 750 mg/m 2 , doxorubicin 50 mg/m 2 , and vincristine 1·4 mg/m 2 [to a maximum of 2 mg total dose] intravenously on day 1 of the cycle, and prednisolone 100 mg orally once daily on days 1-5). During this time, we did gene-expression profiling using whole genome cDNA-mediated annealing, selection, extension, and ligation assay of tissue from routine diagnostic biopsy samples to determine the cell-of-origin subtype of each participant (germinal centre B cell, activated B cell, or unclassified). Patients were then centrally randomly assigned (1:1) via a web-based system, with block randomisation stratified by international prognostic index score and cell-of-origin subtype, to continue R-CHOP alone (R-CHOP group; control), or with bortezomib (RB-CHOP group; experimental; 1·3 mg/m 2 intravenously or 1·6 mg/m 2 subcutaneously) on days 1 and 8 for cycles two to six. If RNA extracted from the diagnostic tissues was of insufficient quality or quantity, participants were given R-CHOP as per the control group. The primary endpoint was 30-month progression-free survival, for the germinal centre and activated B-cell population. The primary analysis was on the modified intention-to-treat population of activated and germinal centre B-cell population. Safety was assessed in all participants who were given at least one dose of study drug. We report the progression-free survival and safety outcomes for patients in the follow-up phase after the required number of events occurred. This study was registered at ClinicalTrials.gov, number NCT01324596, and recruitment and treatment has completed for all participants, with long-term follow-up ongoing.
FINDINGS
Between June 2, 2011, and June 10, 2015, 1128 eligible patients were registered, of whom 918 (81%) were randomly assigned to receive treatment (n=459 to R-CHOP, n=459 to RB-CHOP), comprising 244 (26·6%) with activated B-cell disease, 475 (51·7%) with germinal centre B cell disease, and 199 (21·7%) with unclassified disease. At a median follow-up of 29·7 months (95% CI 29·0-32·0), we saw no evidence for a difference in progression-free survival in the combined germinal centre and activated B-cell population between R-CHOP and RB-CHOP (30-month progression-free survival 70·1%, 95% CI 65·0-74·7 vs 74·3%, 69·3-78·7; hazard ratio 0·86, 95% CI 0·65-1·13; p=0·28). The most common grade 3 or worse adverse event was haematological toxicity, reported in 178 (39·8%) of 447 patients given R-CHOP and 187 (42·1%) of 444 given RB-CHOP. However, RB-CHOP was not associated with increased haematological toxicity and 398 [87·1%] of 459 participants assigned to receive RB-CHOP completed six cycles of treatment. Grade 3 or worse neuropathy occurred in 17 (3·8%) patients given RB-CHOP versus eight (1·8%) given R-CHOP. Serious adverse events occurred in 190 (42·5%) patients given R-CHOP, including five treatment-related deaths, and 223 (50·2%) given RB-CHOP, including four treatment-related deaths.
INTERPRETATION
This is the first large-scale study in diffuse large B-cell lymphoma to use real-time molecular characterisation for prospective stratification, randomisation, and subsequent analysis of biologically distinct subgroups of patients. The addition of bortezomib did not improve progression-free survival.
FUNDING
Janssen-Cilag, Bloodwise, and Cancer Research UK.",2019,"The primary endpoint was 30-month progression-free survival, for the germinal centre and activated B-cell population.","['patients with these subtypes', 'diffuse large B-cell lymphoma with', 'Eligible patients had previously untreated, histologically confirmed diffuse large B-cell lymphoma with sufficient diagnostic material from initial biopsies for gene-expression profiling and pathology review; were aged 18 years or older; had ECOG performance status of 2 or less; had bulky stage', 'Between June 2, 2011, and June 10, 2015, 1128 eligible patients were registered, of whom 918 (81', 'all participants, with long-term follow-up ongoing', 'participants were recruited from 107 cancer centres in the UK (n=94) and Switzerland (n=13', 'participants who were given at least one dose of study drug']","['bortezomib (REMoDL-B', 'standard chemoimmunotherapy', 'continue R-CHOP alone (R-CHOP group; control), or with bortezomib (RB-CHOP group; experimental; 1·3 mg/m 2 intravenously or 1·6', 'bortezomib', 'standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP; rituximab 375 mg/m 2 , cyclophosphamide 750 mg/m 2 , doxorubicin 50 mg/m 2 , and vincristine 1·4', 'prednisolone', 'molecular guided therapy']","['progression-free survival and safety outcomes', 'Grade 3 or worse neuropathy', 'progression-free survival', 'measurable disease; and had cardiac, lung, renal, and liver function sufficient to tolerate chemotherapy', '30-month progression-free survival, for the germinal centre and activated B-cell population', 'haematological toxicity', 'Serious adverse events', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0752248', 'cui_str': 'Gene Expression Monitoring'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1128.0,0.275044,"The primary endpoint was 30-month progression-free survival, for the germinal centre and activated B-cell population.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Cancer Research UK Centre, University of Southampton, Southampton, UK; Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Cummin', 'Affiliation': 'Cancer Research UK Centre, University of Southampton, Southampton, UK; Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Barrans', 'Affiliation': 'Haematological Malignancy Diagnostic Service, Leeds Cancer Centre, Leeds Teaching Hospitals, Leeds, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Maishman', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mamot', 'Affiliation': 'Medical Oncology, Cantonal Hospital Aarau, Switzerland.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Novak', 'Affiliation': 'Department of Medical Oncology, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Caddy', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Stanton', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Kazmi-Stokes', 'Affiliation': 'Centre for Drug Development, Cancer Research UK, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McMillan', 'Affiliation': 'Department of Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fields', 'Affiliation': ""Department of Haematology, Guy's and St Thomas' Hospitals NHS Trust, Kings Health Partners, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pocock', 'Affiliation': 'Department of Haematology, East Kent Hospitals University Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Collins', 'Affiliation': 'Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stephens', 'Affiliation': 'National Cancer Research Institute Consumer Forum, London, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cucco', 'Affiliation': 'Department of Pathology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Clipson', 'Affiliation': 'Department of Pathology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Chulin', 'Initials': 'C', 'LastName': 'Sha', 'Affiliation': 'School of Molecular and Cellular Biology, Faculty of Biological Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Tooze', 'Affiliation': 'Haematological Malignancy Diagnostic Service, Leeds Cancer Centre, Leeds Teaching Hospitals, Leeds, UK; Section of Experimental Haematology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Care', 'Affiliation': 'Section of Experimental Haematology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ming-Qing', 'Initials': 'MQ', 'LastName': 'Du', 'Affiliation': 'Department of Pathology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Westhead', 'Affiliation': 'School of Molecular and Cellular Biology, Faculty of Biological Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Burton', 'Affiliation': 'Haematological Malignancy Diagnostic Service, Leeds Cancer Centre, Leeds Teaching Hospitals, Leeds, UK.'}, {'ForeName': 'Peter W M', 'Initials': 'PWM', 'LastName': 'Johnson', 'Affiliation': 'Cancer Research UK Centre, University of Southampton, Southampton, UK. Electronic address: johnsonp@soton.ac.uk.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30935-5']
1360,30948626,Long-term follow-up in an open-label trial of triheptanoin in GLUT1 deficiency syndrome: a sustained dramatic effect.,,2019,,['GLUT1 deficiency syndrome'],['triheptanoin'],[],"[{'cui': 'C1847501', 'cui_str': 'Glut1 Deficiency Syndrome'}]","[{'cui': 'C2604598', 'cui_str': 'triheptanoin'}]",[],,0.0194047,,"[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Hainque', 'Affiliation': 'Department of Neurology, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France.'}, {'ForeName': 'Domitille', 'Initials': 'D', 'LastName': 'Gras', 'Affiliation': 'Department of Child Neurology, Hopital Universitaire Robert-Debre, Paris, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Meneret', 'Affiliation': 'Department of Neurology, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Atencio', 'Affiliation': 'UMR S 1127, Inserm U 1127, and CNRS UMR 7225, and Institut du Cerveau et de la Moëlle épinière, Paris, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Luton', 'Affiliation': 'UMR S 1127, Inserm U 1127, and CNRS UMR 7225, and Institut du Cerveau et de la Moëlle épinière, Paris, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Barbier', 'Affiliation': 'UMR S 1127, Inserm U 1127, and CNRS UMR 7225, and Institut du Cerveau et de la Moëlle épinière, Paris, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Doulazmi', 'Affiliation': 'Sorbonne Universités, UPMC Paris 06, CNRS UMR8256, Institut de Biologie Paris Seine, Adaptation Biologique et vieillissement, Paris, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Habarou', 'Affiliation': 'Department of Biochemistry, Hopital universitaire Necker-Enfants malades, Paris, France.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ottolenghi', 'Affiliation': 'Department of Biochemistry, Hopital universitaire Necker-Enfants malades, Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Roze', 'Affiliation': 'Department of Neurology, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Mochel', 'Affiliation': 'UMR S 1127, Inserm U 1127, and CNRS UMR 7225, and Institut du Cerveau et de la Moëlle épinière, Paris, France fanny.mochel@upmc.fr.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2018-320283']
1361,30942862,Influences of Hypoxia Exercise on Whole-Body Insulin Sensitivity and Oxidative Metabolism in Older Individuals.,"CONTEXT
Aging is a primary risk factor for most chronic diseases, including type 2 diabetes. Both exercise and hypoxia regulate pathways that ameliorate age-associated metabolic muscle dysfunction.
OBJECTIVE
We hypothesized that the combination of hypoxia and exercise would be more effective in improving glucose metabolism than normoxia exercise.
DESIGN AND PARTICIPANTS
We randomized 29 older sedentary individuals (62 ± 6 years; 14 women, 15 men) to bicycle exercise under normobaric hypoxia (fraction of inspired oxygen = 15%) or normoxia (fraction of inspired oxygen = 21%).
INTERVENTION
Participants trained thrice weekly for 30 to 40 minutes over 8 weeks at a heart rate corresponding to 60% to 70% of peak oxygen update.
MAIN OUTCOME MEASURES
Insulin sensitivity measured by hyperinsulinemic-euglycemic glucose clamp and muscle protein expression before and after hyperinsulinemic-euglycemic glucose clamp.
RESULTS
Heart rate and perceived exertion during training were similar between groups, with lower oxygen saturation when exercising under hypoxia (88.7 ± 1.5 vs 96.2 ± 1.2%, P < 0.01). Glucose infusion rate after 8 weeks increased in both the hypoxia (5.7 ± 1.1 to 6.7 ± 1.3 mg/min/kg; P < 0.01) and the normoxia group (6.2 ± 2.1 to 6.8 ± 2.1 mg/min/kg; P = 0.04), with a mean difference between groups of -0.44 mg/min/kg; 95% CI, -1.22 to 0.34; (P = 0.25). Markers of mitochondrial content and oxidative capacity in skeletal muscle were similar after training in both groups. Changes in Akt phosphorylation and glucose transporter 4 under fasting and insulin-stimulated conditions were not different between groups over time.
CONCLUSIONS
Eight weeks of hypoxia endurance training led to similar changes in insulin sensitivity and markers of oxidative metabolism compared with normoxia training. Normobaric hypoxia exercise did not enhance metabolic effects in sedentary older women and men beyond exercise alone.",2019,"Changes in Akt (Ser473) phosphorylation and GLUT4 under fasting and insulin-stimulated conditions were not different between groups over time.
","['Older Individuals', 'sedentary older women and men beyond exercise alone', '29 older sedentary individuals (62±6 years, 14 women, 15 men) to']","['Normobaric hypoxia exercise', 'Hypoxia Exercise', 'hypoxia and exercise', 'bicycle exercise under normobaric hypoxia (FIO2=15%) or normoxia (FIO2=21', 'hypoxia endurance training']","['Glucose infusion rate', 'Heart rate and perceived exertion', 'insulin sensitivity and markers of oxidative metabolism', 'metabolic effects', 'Insulin sensitivity measured by hyperinsulinemic-euglycemic glucose clamp (HEGC), and muscle protein expression before and after HEGC', 'hypoxia', 'Changes in Akt (Ser473) phosphorylation and GLUT4 under fasting and insulin-stimulated conditions', 'Whole Body Insulin Sensitivity and Oxidative Metabolism']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015159', 'cui_str': 'Glucose Clamping'}, {'cui': 'C0026832', 'cui_str': 'Muscle Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}]",29.0,0.0958138,"Changes in Akt (Ser473) phosphorylation and GLUT4 under fasting and insulin-stimulated conditions were not different between groups over time.
","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Chobanyan-Jürgens', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Renate J', 'Initials': 'RJ', 'LastName': 'Scheibe', 'Affiliation': 'Institute of Cell Biochemistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Arne B', 'Initials': 'AB', 'LastName': 'Potthast', 'Affiliation': 'Department of Pediatrics, Pediatric Metabolic Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Institute of Biometry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freund', 'Affiliation': 'Institute of Cell Biochemistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Anibh M', 'Initials': 'AM', 'LastName': 'Das', 'Affiliation': 'Department of Pediatrics, Pediatric Metabolic Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Engeli', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Haufe', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00411']
1362,31816103,Using stakeholder perspectives to guide systematic adaptation of an autism mental health intervention for Latinx families: A qualitative study.,"Embedded within a Hybrid Type 1 randomized effectiveness-implementation trial in publicly funded mental health services, the current study identified stakeholder recommendations to inform cultural adaptations to An Individualized Mental Health Intervention for Autism Spectrum Disorder (AIM HI) for Latinx and Spanish-speaking families. Recommendations were collected through focus groups with therapists (n = 17) and semi-structured interviews with Latinx parents (n = 29). Relevant themes were identified through a rapid assessment analysis process and thematic coding of interviews. Adaptations were classified according to the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to facilitate fit, acceptability, and sustained implementation of AIM HI and classify the content, nature, and goals of the adaptations. Recommended adaptations were classified through FRAME as tailoring training and intervention materials, changing packaging or materials, extending intervention pacing, and integrating supplemental training strategies. Goals for adaptations included improving fit for stakeholders, increasing parent engagement, and enhancing intervention effectiveness. The current study illustrates the process of embedding an iterative process of intervention adaptation within a hybrid effectiveness-implementation trial. The next steps in this study are to integrate findings with implementation process data from the parent trial to develop a cultural enhancement to AIM HI and test the enhancement in a Hybrid Type 3 implementation-effectiveness trial.",2020,"Embedded within a Hybrid Type 1 randomized effectiveness-implementation trial in publicly funded mental health services, the current study identified stakeholder recommendations to inform cultural adaptations to An Individualized Mental Health Intervention for Autism Spectrum Disorder (AIM HI) for Latinx and Spanish-speaking families.","['publicly funded mental health services', 'autism mental health intervention for Latinx families']",['Individualized Mental Health Intervention'],[],"[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],,0.0324744,"Embedded within a Hybrid Type 1 randomized effectiveness-implementation trial in publicly funded mental health services, the current study identified stakeholder recommendations to inform cultural adaptations to An Individualized Mental Health Intervention for Autism Spectrum Disorder (AIM HI) for Latinx and Spanish-speaking families.","[{'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Chlebowski', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Hurwich-Reiss', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California.'}, {'ForeName': 'Blanche', 'Initials': 'B', 'LastName': 'Wright', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brookman-Frazee', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California.'}]",Journal of community psychology,['10.1002/jcop.22296']
1363,30929004,"Corrigendum to: Ambulatory heart rate reduction after catheter-based renal denervation in hypertensive patients not receiving anti-hypertensive medications: data from SPYRAL HTN-OFF MED, a randomized, sham-controlled, proof-of-concept trial.",,2019,,['hypertensive patients not receiving anti-hypertensive medications'],['Corrigendum to: Ambulatory heart rate reduction after catheter-based renal denervation'],[],"[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}]",[],,0.0220129,,[],European heart journal,['10.1093/eurheartj/ehz184']
1364,31714582,Efficacy of α-Blockers on Hemodynamic Control during Pheochromocytoma Resection: A Randomized Controlled Trial.,"CONTEXT
Pretreatment with α-adrenergic receptor blockers is recommended to prevent hemodynamic instability during resection of a pheochromocytoma or sympathetic paraganglioma (PPGL).
OBJECTIVE
To determine which type of α-adrenergic receptor blocker provides the best efficacy.
DESIGN
Randomized controlled open-label trial (PRESCRIPT; ClinicalTrials.gov NCT01379898).
SETTING
Multicenter study including 9 centers in The Netherlands.
PATIENTS
134 patients with nonmetastatic PPGL.
INTERVENTION
Phenoxybenzamine or doxazosin starting 2 to 3 weeks before surgery using a blood pressure targeted titration schedule. Intraoperative hemodynamic management was standardized.
MAIN OUTCOME MEASURES
Primary efficacy endpoint was the cumulative intraoperative time outside the blood pressure target range (ie, SBP >160 mmHg or MAP <60 mmHg) expressed as a percentage of total surgical procedure time. Secondary efficacy endpoint was the value on a hemodynamic instability score.
RESULTS
Median cumulative time outside blood pressure targets was 11.1% (interquartile range [IQR]: 4.3-20.6] in the phenoxybenzamine group compared to 12.2% (5.3-20.2)] in the doxazosin group (P = .75, r = 0.03). The hemodynamic instability score was 38.0 (28.8-58.0) and 50.0 (35.3-63.8) in the phenoxybenzamine and doxazosin group, respectively (P = .02, r = 0.20). The 30-day cardiovascular complication rate was 8.8% and 6.9% in the phenoxybenzamine and doxazosin group, respectively (P = .68). There was no mortality after 30 days.
CONCLUSIONS
The duration of blood pressure outside the target range during resection of a PPGL was not different after preoperative treatment with either phenoxybenzamine or doxazosin. Phenoxybenzamine was more effective in preventing intraoperative hemodynamic instability, but it could not be established whether this was associated with a better clinical outcome.",2020,"The 30-day cardiovascular complication rate was 8.8% and 6.9% in the phenoxybenzamine and doxazosin group, respectively (P=0.68).","['134 patients with non-metastatic PPGL', 'Multicenter study including 9 centers in The Netherlands']","['phenoxybenzamine', 'Phenoxybenzamine', 'doxazosin', 'α-blockers', 'phenoxybenzamine or doxazosin', 'α-adrenergic receptor blockers', 'phenoxybenzamine and doxazosin']","['mortality', '30-day cardiovascular complication rate', 'cumulative intraoperative time outside the blood pressure target range (i.e., SBP >160 mmHg or MAP <60 mmHg) expressed as a percentage of total surgical procedure time', 'duration of blood pressure', 'hemodynamic instability score', 'intraoperative hemodynamic instability', 'Median cumulative time outside blood pressure targets']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0031441', 'cui_str': 'Phenoxybenzamine'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",134.0,0.097698,"The 30-day cardiovascular complication rate was 8.8% and 6.9% in the phenoxybenzamine and doxazosin group, respectively (P=0.68).","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Buitenwerf', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Thamara E', 'Initials': 'TE', 'LastName': 'Osinga', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henri J L M', 'Initials': 'HJLM', 'LastName': 'Timmers', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jacques W M', 'Initials': 'JWM', 'LastName': 'Lenders', 'Affiliation': 'Department of Internal Medicine, Section of Vascular Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Feelders', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Elisabeth M W', 'Initials': 'EMW', 'LastName': 'Eekhoff', 'Affiliation': 'Department of Internal Medicine, Endocrinology Section, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Harm R', 'Initials': 'HR', 'LastName': 'Haak', 'Affiliation': 'Department of Internal Medicine, Máxima Medical Center, Eindhoven, The Netherlands.'}, {'ForeName': 'Eleonora P M', 'Initials': 'EPM', 'LastName': 'Corssmit', 'Affiliation': 'Department of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Peter H L T', 'Initials': 'PHLT', 'LastName': 'Bisschop', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerlof D', 'Initials': 'GD', 'LastName': 'Valk', 'Affiliation': 'Department of Endocrine Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Ronald Groote', 'Initials': 'RG', 'LastName': 'Veldman', 'Affiliation': 'Department of Internal Medicine, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Robin P F', 'Initials': 'RPF', 'LastName': 'Dullaart', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Thera P', 'Initials': 'TP', 'LastName': 'Links', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Magiel F', 'Initials': 'MF', 'LastName': 'Voogd', 'Affiliation': 'Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Götz J K G', 'Initials': 'GJKG', 'LastName': 'Wietasch', 'Affiliation': 'Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Michiel N', 'Initials': 'MN', 'LastName': 'Kerstens', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz188']
1365,31711168,Effect of Electronic Health Record-Based Coaching on Weight Maintenance: A Randomized Trial.,"Background
Weight regain after intentional loss is common. Most evidence-based weight management programs focus on short-term loss rather than long-term maintenance.
Objective
To evaluate the benefit of coaching in an electronic health record (EHR)-based weight maintenance intervention.
Design
Randomized controlled trial. (ClinicalTrials.gov: NCT01946191).
Setting
Practices affiliated with an academic medical center.
Participants
Adult outpatients with body mass index (BMI) of 25 kg/m2 or higher, intentional weight loss of at least 5% in the previous 2 years, and no bariatric procedures in the previous 5 years.
Intervention
Participants were randomly assigned to EHR tools (tracking group) versus EHR tools plus coaching (coaching group). The EHR tools included weight, diet, and physical activity tracking flow sheets; standardized surveys; and reminders. The coaching group received 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.
Measurements
The primary outcome was weight change at 24 months. Secondary outcomes included 5% weight loss maintenance and changes in BMI, waist circumference, number of steps per day, health-related quality of life, physical function, blood pressure, and satisfaction.
Results
Among 194 randomly assigned participants (mean age, 53.4 years [SD, 12.2]; 143 [74%] women; 171 [88%] white), 157 (81%) completed the trial. Mean baseline weight and BMI were 85.8 kg (SD, 19.1) and 30.4 kg/m2 (SD, 5.9). At 24 months, mean weight regain (± SE) was 2.1 ± 0.62 kg and 4.9 ± 0.63 kg in the coaching and tracking groups, respectively. The between-group difference in weight change at 24 months was significant (-2.86 kg [95% CI, -4.60 to -1.11 kg]) in the linear mixed model. At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%.
Limitation
Single-site trial, which limits generalizability.
Conclusion
Among adults with intentional weight loss of at least 5%, use of EHR tools plus coaching resulted in less weight regain than EHR tools alone.
Primary Funding Source
Agency for Healthcare Research and Quality and National Institutes of Health.",2019,"At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%.
","['adults with', '194 randomly assigned participants (mean age, 53.4 years [SD, 12.2', '143 [74%] women; 171 [88%] white), 157 (81%) completed the trial', 'Participants\n\n\nAdult outpatients with body mass index (BMI) of 25 kg/m2 or higher, intentional weight loss of at least 5% in the previous 2 years, and no bariatric procedures in the previous 5 years', 'Setting\n\n\nPractices affiliated with an academic medical center']","['Electronic Health Record-Based Coaching', 'EHR tools (tracking group) versus EHR tools plus coaching (coaching group', 'personalized coaching through the EHR patient portal, with 24 scheduled contacts']","['weight change', 'Mean baseline weight and BMI', '5% weight loss maintenance and changes in BMI, waist circumference, number of steps per day, health-related quality of life, physical function, blood pressure, and satisfaction', 'mean weight regain (±\xa0SE', 'weight loss', 'intentional weight loss', 'weight regain', 'Weight Maintenance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}]",194.0,0.154702,"At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%.
","[{'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'University of Utah, Salt Lake City, Utah (M.B.C., R.H.).'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Bryce', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tudorascu', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Bethany Barone', 'Initials': 'BB', 'LastName': 'Gibbs', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Arnold', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Comer', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hess', 'Affiliation': 'University of Utah, Salt Lake City, Utah (M.B.C., R.H.).'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Laurey R', 'Initials': 'LR', 'LastName': 'Simkin-Silverman', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Fischer', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}]",Annals of internal medicine,['10.7326/M18-3337']
1366,31363961,Does Lifestyle Intervention After Gastric Bypass Surgery Prevent Weight Regain? A Randomized Clinical Trial.,"BACKGROUND
Weight regain after bariatric surgery often starts after 1-2 y, but studies evaluating strategies to prevent weight regain are lacking. The aim of this intervention was to evaluate the efficacy of a 2-y-group-based lifestyle intervention starting approximately 2 y after Roux-en-Y gastric bypass (RYGB) compared with usual care on weight regain and related metabolic risk factors.
METHODS
A total of 165 patients with a mean of 21 months (range 14-32) after RYGB were randomized to a lifestyle intervention group (LIG) or a usual care group (UCG). Of the 165 participants 86% completed the study. The LIG was offered 16 group meetings over 2 y with focus on healthy diet, physical activity, and behavioural strategies to prevent weight regain, in addition to usual care.
RESULTS
Mean (SD) total weight loss at study start was 30.1 ± 8.2%, while weight regain during the intervention was 4.9 ± 7.4 and 4.6 ± 9.2% in the LIG and UCG, respectively (P = 0.84). There were no differences in metabolic risk factors between the groups. The LIG participants attended 8 ± 4 group meetings, with no difference in weight regain between participants with high compared to lower participation. In all the participants, a positive association between weight increase from nadir to study start and weight regain during the intervention was found. Participants who reported physical activity ≥ 150 min/wk had smaller % weight regain compared with less active participants (β = - 5.2 [SE 2.0, 95% CI - 9.1 to - 1.4]).
CONCLUSION
We found no difference in weight regain between LIG and UCG.",2019,"150 min/wk had smaller % weight regain compared with less active participants (β = - 5.2 [SE 2.0, 95% CI - 9.1 to - 1.4]).
","['165 participants 86% completed the study', 'Participants who reported physical activity\u2009≥', '165 patients with a mean of 21\xa0months (range 14-32) after RYGB']","['2-y-group-based lifestyle intervention starting approximately 2\xa0y after Roux-en-Y gastric bypass (RYGB', 'lifestyle intervention group (LIG) or a usual care group (UCG', 'Lifestyle Intervention']","['Mean (SD) total weight loss', 'metabolic risk factors', 'weight regain']","[{'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",165.0,0.0321828,"150 min/wk had smaller % weight regain compared with less active participants (β = - 5.2 [SE 2.0, 95% CI - 9.1 to - 1.4]).
","[{'ForeName': 'Susanna E', 'Initials': 'SE', 'LastName': 'Hanvold', 'Affiliation': 'Section of Nutrition and Dietetics, Department of Clinical Service, Division of Medicine, Oslo University Hospital, Oslo, Norway. susanna@hanvold.no.'}, {'ForeName': 'Kathrine J', 'Initials': 'KJ', 'LastName': 'Vinknes', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Elin B', 'Initials': 'EB', 'LastName': 'Løken', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Hjartåker', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Klungsøyr', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department for Research and Education, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Birkeland', 'Affiliation': 'Section of Nutrition and Dietetics, Department of Clinical Service, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Risstad', 'Affiliation': 'Department of Endocrinology, Morbid Obesity and Preventive Medicine, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hanne L', 'Initials': 'HL', 'LastName': 'Gulseth', 'Affiliation': 'Department of Endocrinology, Morbid Obesity and Preventive Medicine, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Refsum', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Aas', 'Affiliation': 'Section of Nutrition and Dietetics, Department of Clinical Service, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}]",Obesity surgery,['10.1007/s11695-019-04109-7']
1367,30939096,"Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.","PURPOSE
The Adjuvant Paclitaxel and Trastuzumab trial was designed to address treatment of patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The primary analysis of the Adjuvant Paclitaxel and Trastuzumab trial demonstrated a 3-year disease-free survival (DFS) of 98.7%. In this planned secondary analysis, we report longer-term outcomes and exploratory results to characterize the biology of small HER2-positive tumors and genetic factors that may predispose to paclitaxel-induced peripheral neuropathy (TIPN).
PATIENTS AND METHODS
In this phase II study, patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received paclitaxel (80 mg/m 2 ) with trastuzumab for 12 weeks, followed by trastuzumab for 9 months. The primary end point was DFS. Recurrence-free interval (RFI), breast cancer-specific survival, and overall survival (OS) were also analyzed. In an exploratory analysis, intrinsic subtyping by PAM50 (Prosigna) and calculation of the risk of recurrence score were performed on the nCounter analysis system on archival tissue. Genotyping was performed to investigate TIPN.
RESULTS
A total of 410 patients were enrolled from October 2007 to September 2010. After a median follow-up of 6.5 years, there were 23 DFS events. The 7-year DFS was 93% (95% CI, 90.4 to 96.2) with four (1.0%) distant recurrences, 7-year OS was 95% (95% CI, 92.4 to 97.7), and 7-year RFI was 97.5% (95% CI, 95.9 to 99.1). PAM50 analyses (n = 278) showed that most tumors were HER2-enriched (66%), followed by luminal B (14%), luminal A (13%), and basal-like (8%). Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437 , associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
CONCLUSION
With longer follow-up, adjuvant paclitaxel and trastuzumab is associated with excellent long-term outcomes. Distribution of PAM50 intrinsic subtypes in small HER2-positive tumors is similar to that previously reported for larger tumors.",2019,"Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437, associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
","['patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received', '410 patients were enrolled from October 2007 to September 2010', 'patients with grade 2 or greater TIPN (10.4', 'patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer']","['adjuvant paclitaxel and trastuzumab', 'trastuzumab', 'paclitaxel']","['distant recurrences, 7-year OS', 'Recurrence-free interval (RFI), breast cancer-specific survival, and overall survival (OS', '7-year RFI', '3-year disease-free survival (DFS', 'DFS', '7-year DFS', 'risk of TIPN']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",410.0,0.0620248,"Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437, associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Dillon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Ritterhouse', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': '5Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': '5Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Fuhrman', 'Affiliation': 'NanoString Technologies, Seattle, WA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baltay', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Chau T', 'Initials': 'CT', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': '9Sarah Cannon Cancer Center, Nashville, TN.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Moy', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'P Kelly', 'Initials': 'PK', 'LastName': 'Marcom', 'Affiliation': 'Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Baylor Clinic Lester and Sue Smith Breast Center, Houston, TX.'}, {'ForeName': 'Iuliana', 'Initials': 'I', 'LastName': 'Shapira', 'Affiliation': 'Hofstra North Shore-LIJ School of Medicine, New Hyde Park, NY.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Overmoyer', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Harold J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00066']
1368,30924165,Pharmacokinetic and pharmacodynamic study of lenograstim for hematopoietic stem cell mobilization: a prospective randomized study for optimal apheresis.,"BACKGROUND
This study evaluated the correlation between the pharmacokinetics and pharmacodynamics of granulocyte colony-stimulating factor (lenograstim) and the impact of initiation time of apheresis on stem cell mobilization in patients with multiple myeloma.
STUDY DESIGN AND METHODS
Twenty-four patients with multiple myeloma were randomized into one of the two groups (early vs. late). Lenograstim at 10 μg/kg/day once daily was injected for at least 4 consecutive days. Apheresis was initiated 2 hours after the fourth dose of lenograstim in the early collection group and 16 hours after the fourth dose of lenograstim in the late collection group. Blood sampling for pharmacokinetics was performed within 30 minutes before, and 1, 2, 6, and 24 hours after the fourth dose of lenograstim.
RESULTS
Overall, the two groups (early vs. late, n = 10 vs. 14) exhibited similar baseline characteristics including age, sex, subtype of myeloma, stage distribution, and myeloma-associated symptoms. No correlation was found between plasma lenograstim concentration and peripheral blood (PB) CD34+ cell counts or hematopoietic progenitor cells. In the late collection group, the median number of apheresis procedures for minimal collection was significantly lower (early vs. late: 2 vs. 1; p = 0.04) and there was a higher number of total collected PB CD34+ cells in a single session of apheresis (1.4 vs. 3.1; p = 0.06). There were no differences in median overall PB stem cell collection efficiency.
CONCLUSION
Late collection positively impacted the number of apheresis procedures for minimal collection, with numerically improved PB stem cell collection efficiency at first apheresis in patients with multiple myeloma.",2019,"Late collection positively impacted the number of apheresis procedures for minimal collection, with numerically improved PB stem cell collection efficiency at first apheresis in patients with multiple myeloma.","['Twenty-four patients with multiple myeloma', 'hematopoietic stem cell mobilization', 'patients with multiple myeloma']","['granulocyte colony-stimulating factor (lenograstim', 'Lenograstim', 'lenograstim']","['PB stem cell collection efficiency', 'plasma lenograstim concentration and peripheral blood (PB) CD34+ cell counts or hematopoietic progenitor cells', 'median number of apheresis procedures for minimal collection', 'median overall PB stem cell collection efficiency', 'total collected PB CD34+ cells']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0524864', 'cui_str': 'Stem Cell Mobilization'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0218640', 'cui_str': 'lenograstim'}]","[{'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0218640', 'cui_str': 'lenograstim'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",24.0,0.0502225,"Late collection positively impacted the number of apheresis procedures for minimal collection, with numerically improved PB stem cell collection efficiency at first apheresis in patients with multiple myeloma.","[{'ForeName': 'Jihoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung Yong', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dok Hyun', 'Initials': 'DH', 'LastName': 'Yoon', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyu-Pyo', 'Initials': 'KP', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung Min', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung Sun', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Cheolwon', 'Initials': 'C', 'LastName': 'Suh', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}]",Transfusion,['10.1111/trf.15265']
1369,30920880,"Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial.","PURPOSE
This trial aimed to assess the efficacy and safety of the paclitaxel plus fluorouracil regimen versus the cisplatin plus fluorouracil regimen in definitive concurrent chemoradiotherapy (dCRT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC).
PATIENTS AND METHODS
Patients with locally advanced ESCC were enrolled and randomly assigned to either the paclitaxel plus fluorouracil group or the cisplatin plus fluorouracil group. The patients in the paclitaxel plus fluorouracil group were treated with paclitaxel and fluorouracil one cycle per week in dCRT for five cycles followed by paclitaxel and fluorouracil one cycle per month in consolidation chemotherapy for two cycles. The patients in the cisplatin/5-fluorouracil group were treated with cisplatin and fluorouracil one cycle per month in dCRT for two cycles followed by two cycles in consolidation chemotherapy. The radiotherapy dose was 61.2 Gy delivered in 34 fractions. The primary end point was 3-year overall survival (OS).
RESULTS
Four hundred thirty-six patients with ESCC in six centers were recruited at a 1:1 ratio between April 2012 and July 2015. The median follow-up of the surviving patients was 48.7 months (interquartile range, 42.6-60.9). The 3-year OS was 55.4% in the paclitaxel plus fluorouracil group and 51.8% in the cisplatin plus fluorouracil group (hazard ratio, 0.905 [95% CI, 0.698 to 1.172]; P = .448). The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7% v 45.5%, respectively; hazard ratio, 0.973 [95% CI, 0.762 to 1.243]; P = .828). Compared with the cisplatin plus fluorouracil group, the paclitaxel plus fluorouracil group had significantly lower incidences of acute grade 3 or higher anemia, thrombocytopenia, anorexia, nausea, vomiting, and fatigue ( P < .05), but higher incidences of acute grade 3 or higher leukopenia, radiation dermatitis, and radiation pneumonitis ( P < .05).
CONCLUSION
The paclitaxel plus fluorouracil regimen did not significantly prolong the OS compared with the standard cisplatin plus fluorouracil regimen in dCRT in patients with locally advanced ESCC.",2019,"The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7% v 45.5%, respectively; hazard ratio, 0.973","['Four hundred thirty-six patients with ESCC in six centers were recruited at a 1:1 ratio between April 2012 and July 2015', 'Locally Advanced Esophageal Squamous Cell Cancer', 'patients with locally advanced ESCC', 'patients with locally advanced esophageal squamous cell carcinoma (ESCC', 'Patients with locally advanced ESCC']","['paclitaxel plus fluorouracil', 'cisplatin/5-fluorouracil', 'chemoradiotherapy (dCRT', 'Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil', 'radiotherapy', 'standard cisplatin plus fluorouracil', 'cisplatin plus fluorouracil regimen', 'paclitaxel and fluorouracil', 'Chemoradiotherapy', 'cisplatin plus fluorouracil', 'cisplatin and fluorouracil']","['OS', '3-year OS', '3-year progression-free survival', '3-year overall survival (OS', 'efficacy and safety', 'acute grade 3 or higher anemia, thrombocytopenia, anorexia, nausea, vomiting, and fatigue', 'acute grade 3 or higher leukopenia, radiation dermatitis, and radiation pneumonitis']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0206063', 'cui_str': 'Pneumonia, Radiation'}]",436.0,0.0572158,"The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7% v 45.5%, respectively; hazard ratio, 0.973","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jinjun', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': '2 Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Zhengfei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': '3 Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Chaoyang', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""4 Zhenjiang First People's Hospital, Zhenjiang, China.""}, {'ForeName': 'Huarong', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': ""4 Zhenjiang First People's Hospital, Zhenjiang, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': '5 The First Affiliated Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': '6 Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China.'}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': '6 Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': '7 Fujian Provincial Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Saiquan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Kuaile', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02122']
1370,29912723,Balanced Crystalloids Versus Saline for Perioperative Intravenous Fluid Administration in Children Undergoing Neurosurgery: A Randomized Clinical Trial.,"BACKGROUND
Balanced crystalloid solutions induce less hyperchloremia than normal saline, but their role as primary fluid replacement for children undergoing surgery is unestablished. We hypothesized that balanced crystalloids induce less chloride and metabolic derangements than 0.9% saline solutions in children undergoing brain tumor resection.
METHODS
In total, 53 patients (age range, 6 mo to 12 y) were randomized to receive balanced crystalloid (balanced group) or 0.9% saline solution (saline group) during and after (for 24 h) brain tumor resection. Serum electrolyte and arterial blood gas analyses were performed at the beginning of surgery (baseline), after surgery, and at postoperative day 1. The primary trial outcome was the absolute difference in serum chloride concentrations (post-preopΔCl) measured after surgery and at baseline. Secondary outcomes included the post-preopΔ of other electrolytes and base excess (BE); hyperchloremic acidosis incidence; and the brain relaxation score, a 4-point scale evaluated by the surgeon for assessing brain edema.
RESULTS
Saline infusion increased post-preopΔCl (6 [3.5; 8.5] mmol/L) compared with balanced crystalloid (0 [-1.0; 3.0] mmol/L; P<0.001). Saline use also resulted in increased post-preopΔBE (-4.4 [-5.0; -2.3] vs. -0.4 [-2.7; 1.3] mmol/L; P<0.001) and hyperchloremic acidosis incidence (6/25 [24%] vs. 0; P=0.022) compared with balanced crystalloid. Brain relaxation score was comparable between groups.
CONCLUSIONS
In children undergoing brain tumor resection, saline infusion increased variation in serum chloride compared with balanced crystalloid. These findings support the use of balanced crystalloid solutions in children undergoing brain tumor resection.",2019,"Brain relaxation score was comparable between groups.
","['Children Undergoing Neurosurgery', 'children undergoing surgery', 'children undergoing brain tumor resection', '53 patients (age range, 6\u2009mo to 12\u2009y']","['balanced crystalloid solutions', 'saline infusion', 'Balanced Crystalloids Versus Saline', 'balanced crystalloid (balanced group) or 0.9% saline solution (saline']","['Brain relaxation score', 'absolute difference in serum chloride concentrations (post-preopΔCl', 'Serum electrolyte and arterial blood gas analyses', 'post-preopΔBE', 'post-preopΔ of other electrolytes and base excess (BE); hyperchloremic acidosis incidence; and the brain relaxation score, a 4-point scale evaluated by the surgeon for assessing brain edema', 'hyperchloremic acidosis incidence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0006118', 'cui_str': 'Brain Tumors'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0036787', 'cui_str': 'Serum chloride'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0201985', 'cui_str': 'Base excess - observation'}, {'cui': 'C0085569', 'cui_str': 'Metabolic acidosis, NAG, acidifying salts'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0222045'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1527311', 'cui_str': 'Intracranial Edema'}]",53.0,0.519548,"Brain relaxation score was comparable between groups.
","[{'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Lima', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Iuri S', 'Initials': 'IS', 'LastName': 'Neville', 'Affiliation': 'Neurosurgery, Hospital das Clínicas, University of São Paulo.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Cavalheiro', 'Affiliation': 'Department of Neurosurgery, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Dafne C', 'Initials': 'DC', 'LastName': 'Bourguignon', 'Affiliation': 'Pediatric Intensive Care Unit, Instituto de Oncologia Pediátrica.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, Genoa, Italy.'}, {'ForeName': 'Luiz M S', 'Initials': 'LMS', 'LastName': 'Malbouisson', 'Affiliation': 'Departments of Anesthesiology.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000515']
1371,30928620,"Patient-reported outcomes in patients with resected, high-risk melanoma with BRAF V600E or BRAF V600K mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial.","BACKGROUND
In the phase 3 COMBI-AD study, patients with resected, stage III melanoma with BRAF V600E or BRAF V600K mutations received adjuvant dabrafenib plus trametinib or placebo. The primary analysis showed that dabrafenib plus trametinib significantly improved relapse-free survival at 3 years. These results led to US Food and Drug Administration approval of dabrafenib plus trametinib as adjuvant treatment for patients with resected stage III melanoma with BRAF V600E or BRAF V600K mutations. Here, we report the patient-reported outcomes from COMBI-AD.
METHODS
COMBI-AD was a randomised, double-blind, placebo-controlled, phase 3 study done at 169 sites in 25 countries. Study participants were aged 18 years or older and had complete resection of stage IIIA (lymph node metastases >1 mm), IIIB, or IIIC cutaneous melanoma as per American Joint Committee on Cancer 7th edition criteria, with BRAF V600E or BRAF V600K mutations, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1) via an interactive voice response system, stratified by mutation type and disease stage, to receive oral dabrafenib (150 mg twice daily) plus oral trametinib (2 mg once daily) or matching placebos for 12 months. Patients, physicians, and the investigators who analysed the data were masked to treatment allocation. The primary endpoint was relapse-free survival, reported elsewhere. Health-related quality of life, reported here, was a prespecified exploratory endpoint, and was assessed with the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire in the intention-to-treat population. We used a mixed-model repeated-measures analysis to assess differences in health-related quality of life between groups. This study is registered with ClinicalTrials.gov, number NCT01682083. The trial is ongoing, but is no longer recruiting participants.
FINDINGS
Between Jan 31, 2013, and Dec 11, 2014, 870 patients were enrolled and randomly assigned to receive dabrafenib plus trametinib (n=438) or matching placebos (n=432). Data were collected until the data cutoff for analyses of the primary endpoint (June 30, 2017). The median follow-up was 34 months (IQR 28-39) in the dabrafenib plus trametinib group and 33 months (20·5-39) in the placebo group. During the 12-month treatment phase, there were no significant or clinically meaningful changes from baseline between groups in EQ-5D-3L visual analogue scale (EQ-VAS) or utility scores. During treatment, there were no clinically meaningful differences in VAS scores or utility scores in the dabrafenib plus trametinib group between patients who did and did not experience the most common adverse events. During long-term follow-up (range 15-48 months), VAS and utility scores were similar between groups and did not differ from baseline scores. At recurrence, there were significant decreases in VAS scores in both the dabrafenib plus trametinib group (mean change -6·02, SD 20·57; p=0·0032) and the placebo group (-6·84, 20·86; p<0·0001); the mean change in utility score also differed significantly at recurrence for both groups (dabrafenib plus trametinib -0·0626, 0·1911, p<0·0001; placebo -0·0748, 0·2182, p<0·0001).
INTERPRETATION
These findings show that dabrafenib plus trametinib did not affect patient-reported outcome scores during or after adjuvant treatment, and suggest that preventing or delaying relapse with adjuvant therapy could be beneficial in this setting.
FUNDING
Novartis.",2019,"During long-term follow-up (range 15-48 months), VAS and utility scores were similar between groups and did not differ from baseline scores.","['COMBI-AD', '169 sites in 25 countries', 'Study participants were aged 18 years or older and had complete resection of stage IIIA (lymph node metastases >1 mm), IIIB, or IIIC cutaneous melanoma as per American Joint Committee on Cancer 7th edition criteria, with BRAF V600E or BRAF V600K mutations, and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'Between Jan 31, 2013, and Dec 11, 2014, 870 patients', 'patients with resected, stage III melanoma with BRAF V600E or BRAF V600K mutations received', 'patients with resected stage III melanoma with BRAF V600E or BRAF V600K mutations', 'patients with resected, high-risk melanoma with BRAF V600E or BRAF V600K mutations treated with']","['dabrafenib plus trametinib (n=438) or matching placebos', 'placebo', 'interactive voice response system, stratified by mutation type and disease stage, to receive oral dabrafenib (150 mg twice daily) plus oral trametinib (2 mg once daily) or matching placebos', 'adjuvant dabrafenib plus trametinib (COMBI-AD', 'adjuvant dabrafenib plus trametinib or placebo']","['VAS scores or utility scores', 'European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire', 'relapse-free survival', 'VAS scores', 'EQ-5D-3L visual analogue scale (EQ-VAS) or utility scores', 'mean change in utility score', 'health-related quality of life', 'VAS and utility scores']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0034380'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",870.0,0.791105,"During long-term follow-up (range 15-48 months), VAS and utility scores were similar between groups and did not differ from baseline scores.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santinami', 'Affiliation': 'Fondazione Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, QLD, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Papa Giovanni XXIII Cancer Center Hospital, Bergamo, Italy.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'The Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institute Gustave Roussy, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'Université de Lille, INSERM U 1189, Lille, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lesimple', 'Affiliation': 'Medical Oncology Department, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schachter', 'Affiliation': 'Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Kohinoor', 'Initials': 'K', 'LastName': 'Dasgupta', 'Affiliation': 'Novartis Healthcare, Hyderabad, India.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Manson', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Koruth', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Bijoyesh', 'Initials': 'B', 'LastName': 'Mookerjee', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia; Melanoma Institute Australia, Sydney, NSW, Australia; Westmead Hospital, Sydney, NSW, Australia; The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital Zürich Skin Cancer Center, Zürich, Switzerland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, Sydney, NSW, Australia; The University of Sydney, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia; Mater Hospital, Sydney, NSW, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30940-9']
1372,30937667,Why Content and Cognition Matter: Integrating Conceptual Knowledge to Support Simulation-Based Procedural Skills Transfer.,"BACKGROUND
Curricular constraints require being selective about the type of content trainees practice in their formal training. Teaching trainees procedural knowledge about ""how"" to perform steps of a skill along with conceptual knowledge about ""why"" each step is performed can support skill retention and transfer (i.e., the ability to adapt knowledge to novel problems). However, how best to organize how and why content for procedural skills training is unknown.
OBJECTIVES
We examined the impact of different approaches to integrating why and how content on trainees' skill retention and transfer of simulation-based lumbar puncture (LP).
DESIGN AND PARTICIPANTS
We randomized medical students (N = 66) to practice LP for 1 h using one of three videos. One video presented only the how content for LP (Procedural Only). Two other videos presented how and why content (e.g., anatomy) in two ways: Integrated in Sequence, with why content followed by how content, or Integrated for Causation, with how and why content integrated throughout.
MAIN MEASURES
Pairs of blinded raters scored participants' retention and transfer LP performances on a global rating scale (GRS), and written tests assessed participants' procedural and conceptual knowledge.
KEY RESULTS
Simple mediation regression analyses showed that participants receiving an integrated instructional video performed significantly better on transfer through their intervention's positive impact on conceptual knowledge (all p < 0.01). Further, the Integrated for Causation group performed significantly better on transfer than the Integrated in Sequence group (p < 0.01), again mediated by improved conceptual knowledge. We observed no mediation of participants' skill retention (all p > 0.01).
CONCLUSIONS
When teaching supports cognitive integration of how and why content, trainees are able to transfer learning to new problems because of their improved conceptual understanding. Instructional designs for procedural skills that integrate how and why content can help educators optimize what trainees learn from each repetition of practice.",2019,"KEY RESULTS
Simple mediation regression analyses showed that participants receiving an integrated instructional video performed significantly better on transfer through their intervention's positive impact on conceptual knowledge (all p < 0.01).",['We randomized medical students (N\u2009=\u200966) to'],"['simulation-based lumbar puncture (LP', 'practice LP']","["" retention and transfer LP performances on a global rating scale (GRS), and written tests assessed participants' procedural and conceptual knowledge"", ""participants' skill retention"", 'conceptual knowledge']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0158405,"KEY RESULTS
Simple mediation regression analyses showed that participants receiving an integrated instructional video performed significantly better on transfer through their intervention's positive impact on conceptual knowledge (all p < 0.01).","[{'ForeName': 'Jeffrey J H', 'Initials': 'JJH', 'LastName': 'Cheung', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada. jeffreyjcheung@gmail.com.'}, {'ForeName': 'Kulamakan M', 'Initials': 'KM', 'LastName': 'Kulasegaram', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Woods', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Brydges', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada.'}]",Journal of general internal medicine,['10.1007/s11606-019-04959-y']
1373,30921274,Non-inferiority of Preservative-free versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients with Open-angle Glaucoma or Ocular Hypertension.,"PRECIS
Non-inferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared to a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension.
PURPOSE
To compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension.
METHODS
Phase III,randomizedd, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged ≥18 years with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7±2.4▒mm Hg overall prior to inclusion) were randomised at Day 0 with no washout period to receive the preservative-free alternative T2347 (N=127) or remain on the preserved comparator (N=115) for 84 days. Intraocular pressure changes from Day 0 were measured at 9:00 am (+/-1 hour) on Day 42 and Day 84, and non-inferiority of T2347 to the preserved comparator wasanalyzedd statistically at Day 84. Safety parameters were also reported.
RESULTS
The mean change in intraocular pressure from baseline to Day 84 was -0.49±1.80▒mm Hg for preservative-free T2347 and -0.49±2.25▒mm Hg for the preserved comparator. These results met the non-inferiority limits. Similar results were observed at Day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at Day 84 (45.9%/44.3%/9.8% patients with improvement/no change/worsening versus 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001) and itching (P<0.01) on Day 84.
CONCLUSION
Preservative-free latanoprost-timolol fixed combination T2347 showed non-inferior efficacy compared to the preserved comparator and was well tolerated.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/.",2019,"The total ocular symptoms score was better for T2347 than BPLT upon instillation at Day 84 (45.9%/44.3%/9.8% patients with improvement/no change/worsening versus 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001) and itching (P<0.01) on Day 84.
","['Phase III,randomizedd, parallel-group, investigator-masked study in 10 countries', '15.7±2.4▒mm Hg overall prior to inclusion', '242 patients aged ≥18 years with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved', 'Patients with Open-angle Glaucoma or Ocular Hypertension', 'patients with open-angle glaucoma or ocular hypertension']","['preservative-free alternative T2347 (N=127) or remain on the preserved comparator', 'Preservative-free latanoprost-timolol', 'preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination', 'latanoprost-timolol fixed combination', 'Preservative-free versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops']","['inferior efficacy', 'incidence of adverse events or ocular signs', 'tolerated', 'Intraocular pressure changes', 'individual symptoms such as irritation/burning/stinging', 'mean change in intraocular pressure', 'total ocular symptoms score', 'intraocular pressure and safety']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}]","[{'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0005026', 'cui_str': 'Benzalkonium Chloride'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}]","[{'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",242.0,0.120456,"The total ocular symptoms score was better for T2347 than BPLT upon instillation at Day 84 (45.9%/44.3%/9.8% patients with improvement/no change/worsening versus 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001) and itching (P<0.01) on Day 84.
","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Aptel', 'Affiliation': 'CHU de Grenoble/University Hospital of Grenoble, Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Ophthalmology, Mainz University Medical Center, Mainz, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schmickler', 'Affiliation': 'Augen-Zentrum-Nordwest, Augenpraxis Ahaus, Ahaus, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Cosme', 'Initials': 'C', 'LastName': 'Lavín-Dapena', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Moreno-Montañés', 'Affiliation': 'Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Żarnowski', 'Affiliation': 'Department of Diagnostics and Microsurgery of Glaucoma, Medical University, Lublin, Poland.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Csutak', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Jugaste', 'Affiliation': 'Clinic of Ophthalmology, Tallinn, Estonia.'}, {'ForeName': 'Lāsma', 'Initials': 'L', 'LastName': 'Volksone', 'Affiliation': ""Dr. Volksone's Practice in Ophthalmology, Lavolks Ltd, Rīga, Latvia.""}, {'ForeName': 'Yury S', 'Initials': 'YS', 'LastName': 'Astakhov', 'Affiliation': 'Department of Ophthalmology, Academician I.P. Pavlov First St. Petersburg State Medical University, St. Petersburg, Russia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Coupier', 'Affiliation': ""Centre Hospitalier du Pays d'Aix, Service Ophtalmologie, Aix-en-Provence, France.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Nordmann', 'Affiliation': 'Ophthalmology, CHNO des Quinze-Vingts, Paris, France.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Stalmans', 'Affiliation': 'University Hospitals UZ Leuven, Ophthalmology Department, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001248']
1374,30919899,Cardiovascular outcomes and achieved blood pressure in patients with and without diabetes at high cardiovascular risk.,"AIMS
Studies have shown a non-linear relationship between systolic blood pressure (SBP) and diastolic blood pressure (DBP) and outcomes, with increased risk observed at both low and high blood pressure (BP) levels. We hypothesized that the BP-risk association is different in individuals with and without diabetes at high cardiovascular risk.
METHODS AND RESULTS
We identified patients with (N = 11 487) or without diabetes (N = 19 450), from 30 937 patients, from 133 centres in 44 countries with a median follow-up of 56 months in the ONTARGET/TRANSCEND studies. Patients had a prior history of stroke, myocardial infarction (MI), peripheral artery disease, or were high-risk diabetics. Patients in ONTARGET had been randomized to ramipril 10 mg daily, telmisartan 80 mg daily, or the combination of both. Patients in TRANSCEND were ACE intolerant and randomized to telmisartan 80 mg daily or matching placebo. We analysed the association of mean achieved in-trial SBP and DBP with the composite outcome of cardiovascular death, MI, stroke and hospitalization for congestive heart failure (CHF), the components of the composite, and all-cause death. Data were analysed by Cox regression and restricted cubic splines, adjusting for risk markers including treatment allocation and accompanying cardiovascular treatments. In patients with diabetes, event rates were higher across the whole spectrum of SBP and DBP compared with those without diabetes (P < 0.0001 for the primary composite outcome, P < 0.01 for all other endpoints). Mean achieved in-trial SBP ≥160 mmHg was associated with increased risk for the primary outcome [diabetes/no diabetes: adjusted hazard ratio (HR) 2.31 (1.93-2.76)/1.66 (1.36-2.02) compared with non-diabetics with SBP 120 to <140 mmHg], with similar findings for all other endpoints in patients with diabetes, and for MI and stroke in patients without diabetes. In-trial SBP <120 mmHg was associated with increased risk for the combined outcome in patients with diabetes [HR 1.53 (1.27-1.85)], and for cardiovascular death and all-cause death in all patients. In-trial DBP ≥90 mmHg was associated with increased risk for the primary outcome [diabetes/no diabetes: HR 2.32 (1.91-2.82)/1.61 (1.35-1.93) compared with non-diabetics with DBP 70 to <80 mmHg], with similar findings for all other endpoints, but not for CHF hospitalizations in patients without diabetes. In-trial DBP <70 mmHg was associated with increased risk for the combined outcome in all patients [diabetes/no diabetes: HR 1.77 (1.51-2.06)/1.30 (1.16-1.46)], and also for all other endpoints except stroke.
CONCLUSION
High on treatment BP levels (≥160 or ≥90 mmHg) are associated with increased risk of cardiovascular outcomes and death. Also low levels (<120 or <70 mmHg) are associated with increased cardiovascular outcomes (except stroke) and death. Patients with diabetes have consistently higher risks over the whole BP range, indicating that achieving optimal BP goals is most impactful in this group. These data favour guidelines taking lower BP boundaries into consideration, in particular in diabetes.
CLINICAL TRIAL REGISTRATION
http://clinicaltrials.gov.Unique identifier: NCT00153101.",2019,In-trial DBP <70 mmHg was associated with increased risk for the combined outcome in all patients,"['patients with (N\u2009=\u200911\xa0487) or without diabetes (N\u2009=\u200919\xa0450), from 30\xa0937 patients, from 133 centres in 44 countries with a median follow-up of 56\u2009months in the ONTARGET/TRANSCEND studies', 'Patients with diabetes', 'patients with and without diabetes at high cardiovascular risk', 'individuals with and without diabetes at high cardiovascular risk', 'Patients had a prior history of stroke, myocardial infarction (MI), peripheral artery disease, or were high-risk diabetics']","['telmisartan 80\u2009mg daily or matching placebo', 'ramipril 10\u2009mg daily, telmisartan']","['blood pressure', 'cardiovascular death, MI, stroke and hospitalization for congestive heart failure (CHF), the components of the composite, and all-cause death', 'treatment BP levels', 'blood pressure (BP) levels', 'cardiovascular death and all-cause death', 'risk of cardiovascular outcomes and death', 'cardiovascular outcomes (except stroke) and death', 'systolic blood pressure (SBP) and diastolic blood pressure (DBP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C1607513', 'cui_str': 'telmisartan 80 MG [Micardis]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1617547', 'cui_str': 'Ramipril 10 MG [Altace]'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",30937.0,0.0882535,In-trial DBP <70 mmHg was associated with increased risk for the combined outcome in all patients,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Saarland University Medical Center, Kirrberger Str. 1, Homburg/Saar, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schumacher', 'Affiliation': 'Statistical Consultant, Ingelheim, Germany.'}, {'ForeName': 'Koon K', 'Initials': 'KK', 'LastName': 'Teo', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Lonn', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Klinik für Innere Medizin III, Saarland University Medical Center, Kirrberger Str. 1, Homburg/Saar, Germany.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Centre, Menzinger Str. 44, München, Germany and Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University, Schlossplatz 4, Erlangen, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': ""University of Milano-Bicocca, Istituto Clinico Universitario Policlinico di Monza, Piazza dell'Ateneo Nuovo, 1, Milano, Italy.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Redon', 'Affiliation': 'Hypertension Unit, Hospital CIínico Universitario, University of Valencia, Av. de Blasco Ibáñez, 13, València, Spain.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University, Erlangen, Nuremberg, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine, University Hospital RWTH Aachen, Pauwelsstraße 30, Aachen, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'Faculty of Health Sciences, Hatter Institute for Cardiovascular Research in Africa & IIDMM, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'Downstate College of Medicine, State University of New York, 450 Clarkson Ave, Brooklyn, NY, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'University College London (UCL), Institute of Cardiovascular Science, National Institute for Health Research (NIHR), UCL Hospitals Biomedical Research Centre, 149 Tottenham Court Road, London, UK.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}]",European heart journal,['10.1093/eurheartj/ehz149']
1375,30726693,Phase 1 Trial of an RNA Interference Therapy for Acute Intermittent Porphyria.,"BACKGROUND
Induction of delta aminolevulinic acid synthase 1 ( ALAS1) gene expression and accumulation of neurotoxic intermediates result in neurovisceral attacks and disease manifestations in patients with acute intermittent porphyria, a rare inherited disease of heme biosynthesis. Givosiran is an investigational RNA interference therapeutic agent that inhibits hepatic ALAS1 synthesis.
METHODS
We conducted a phase 1 trial of givosiran in patients with acute intermittent porphyria. In part A of the trial, patients without recent porphyria attacks (i.e., no attacks in the 6 months before baseline) were randomly assigned to receive a single subcutaneous injection of one of five ascending doses of givosiran (0.035, 0.10, 0.35, 1.0, or 2.5 mg per kilogram of body weight) or placebo. In part B, patients without recent attacks were randomly assigned to receive once-monthly injections of one of two doses of givosiran (0.35 or 1.0 mg per kilogram) or placebo (total of two injections 28 days apart). In part C, patients who had recurrent attacks were randomly assigned to receive injections of one of two doses of givosiran (2.5 or 5.0 mg per kilogram) or placebo once monthly (total of four injections) or once quarterly (total of two injections) during a 12-week period, starting on day 0. Safety, pharmacokinetic, pharmacodynamic, and exploratory efficacy outcomes were evaluated.
RESULTS
A total of 23 patients in parts A and B and 17 patients in part C underwent randomization. Common adverse events included nasopharyngitis, abdominal pain, and diarrhea. Serious adverse events occurred in 6 patients who received givosiran in parts A through C combined. In part C, all 6 patients who were assigned to receive once-monthly injections of givosiran had sustained reductions in ALAS1 messenger RNA (mRNA), delta aminolevulinic acid, and porphobilinogen levels to near normal. These reductions were associated with a 79% lower mean annualized attack rate than that observed with placebo (exploratory efficacy end point).
CONCLUSIONS
Once-monthly injections of givosiran in patients who had recurrent porphyria attacks resulted in mainly low-grade adverse events, reductions in induced ALAS1 mRNA levels, nearly normalized levels of the neurotoxic intermediates delta aminolevulinic acid and porphobilinogen, and a lower attack rate than that observed with placebo. (Funded by Alnylam Pharmaceuticals; ClinicalTrials.gov number, NCT02452372 .).",2019,"These reductions were associated with a 79% lower mean annualized attack rate than that observed with placebo (exploratory efficacy end point).
","['Acute Intermittent Porphyria', '23 patients in parts A and B and 17 patients in part C underwent randomization', 'patients who had recurrent attacks', 'patients with acute intermittent porphyria', 'patients without recent porphyria attacks (i.e., no attacks in the 6 months before baseline', 'patients without recent attacks']","['RNA Interference Therapy', 'givosiran', 'placebo']","['ALAS1 messenger RNA (mRNA), delta aminolevulinic acid, and porphobilinogen levels to near normal', 'nasopharyngitis, abdominal pain, and diarrhea', 'recurrent porphyria attacks', 'Safety, pharmacokinetic, pharmacodynamic, and exploratory efficacy outcomes', 'induced ALAS1 mRNA levels', 'attack rate', 'mean annualized attack rate', 'Serious adverse events']","[{'cui': 'C0162565', 'cui_str': 'Acute Porphyria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0032708', 'cui_str': 'Porphyrias'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1136031', 'cui_str': 'Posttranscriptional Gene Silencing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0032704', 'cui_str': '1H-Pyrrole-3-propanoic acid, 5-(aminomethyl)-4-(carboxymethyl)-'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0032708', 'cui_str': 'Porphyrias'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.403633,"These reductions were associated with a 79% lower mean annualized attack rate than that observed with placebo (exploratory efficacy end point).
","[{'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Sardh', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Harper', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Stein', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rees', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'D Montgomery', 'Initials': 'DM', 'LastName': 'Bissell', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Desnick', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Herbert L', 'Initials': 'HL', 'LastName': 'Bonkovsky', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Vassiliou', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Penz', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chan-Daniels', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Querbes', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fitzgerald', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Jae B', 'Initials': 'JB', 'LastName': 'Kim', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Vaishnaw', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Simon', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}, {'ForeName': 'Karl E', 'Initials': 'KE', 'LastName': 'Anderson', 'Affiliation': ""From the Porphyria Centre Sweden, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); Icahn School of Medicine at Mount Sinai, New York (M.B., R.D.); King's College Hospital, London (P.S., D.R.); University of California, San Francisco, San Francisco (D.M.B.); University of Utah, Salt Lake City (C. Parker, J.P.); Wake Forest University, Winston-Salem, NC (H.L.B.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, A.C.-D., Q.H., W.Q., K.F., J.B.K., P.G., A.V., A.R.S.); and the University of Texas Medical Branch at Galveston, Galveston (K.E.A.).""}]",The New England journal of medicine,['10.1056/NEJMoa1807838']
1376,30925539,Cervical Spine Movement During Awake Orotracheal Intubation With Fiberoptic Scope and McGrath Videolaryngoscope in Patients Undergoing Surgery for Cervical Spine Instability: A Randomized Control Trial.,"BACKGROUND
Cervical spine movement during intubation with direct laryngoscopy can predispose to new-onset neurological deficits in patients with cervical spine instability. While fiberoptic-guided intubation (FGI) is mostly preferred in such patients, this is not always possible. Videolaryngoscopy results in less cervical spine movement than direct laryngoscopy and may be an alternative to FGI in patients with cervical spine instability. The objective of this study was to compare cervical spine movement during awake FGI with those during awake McGrath videolaryngoscope-guided intubation (VGI) in patients undergoing surgery for cervical spine instability.
METHODS
Forty-six adult patients with upper cervical spine instability scheduled for stabilization surgery were randomized to awake FGI or awake VGI. Cervical spine movement during intubation was assessed by changes in lateral fluoroscopic-measured angles (α and β at C1/C2 and C3 levels, respectively) at 3 time points: T1, preintubation; T2, during intubation; T3, postintubation. Motor power was assessed before and after intubation.
RESULTS
Patient demographics and airway characteristics were similar between the 2 groups. Cervical spine motion (in degrees) during intubation was significantly greater with VGI than FGI at C1/C2 (T3-T1, -8.02±8.11 vs. -1.47±3.31; P<0.001) but not at C3 (T3-T1, -2.17±5.16 vs. -1.85±3.29; P=0.960). No patient developed new-onset motor deficits following intubation in either group.
CONCLUSIONS
Compared with FGI, VGI results in a greater degree of cervical spine movement at C1/C2 but not at C3.",2020,"during intubation was significantly greater with VGI than FGI at C1/C2 (T3-T1, -8.02±8.11 vs. -1.47±3.31; P<0.001) but not at C3 (T3-T1, -2.17±5.16 vs. -1.85±3.29; P=0.960).","['Forty-six adult patients with upper cervical spine instability scheduled for stabilization surgery', 'Patients Undergoing Surgery for Cervical Spine Instability', 'patients undergoing surgery for cervical spine instability', 'patients with cervical spine instability']","['Awake Orotracheal Intubation With Fiberoptic Scope and McGrath Videolaryngoscope', 'Videolaryngoscopy', 'direct laryngoscopy', 'awake FGI with those during awake McGrath videolaryngoscope-guided intubation (VGI', 'fiberoptic-guided intubation (FGI', 'awake FGI or awake VGI']","['Cervical Spine Movement', 'Motor power', 'Cervical spine movement', 'Cervical spine motion (in degrees', 'new-onset motor deficits', 'cervical spine movement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0410652', 'cui_str': 'Cervical spine instability (disorder)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope (physical object)'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}]",46.0,0.205591,"during intubation was significantly greater with VGI than FGI at C1/C2 (T3-T1, -8.02±8.11 vs. -1.47±3.31; P<0.001) but not at C3 (T3-T1, -2.17±5.16 vs. -1.85±3.29; P=0.960).","[{'ForeName': 'Kaustuv', 'Initials': 'K', 'LastName': 'Dutta', 'Affiliation': 'Departments of Neuroanaesthesia and Neurocritical Care.'}, {'ForeName': 'Kamath', 'Initials': 'K', 'LastName': 'Sriganesh', 'Affiliation': 'Departments of Neuroanaesthesia and Neurocritical Care.'}, {'ForeName': 'Dhritiman', 'Initials': 'D', 'LastName': 'Chakrabarti', 'Affiliation': 'Departments of Neuroanaesthesia and Neurocritical Care.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Pruthi', 'Affiliation': 'Neurosurgery, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, India.'}, {'ForeName': 'Madhusudan', 'Initials': 'M', 'LastName': 'Reddy', 'Affiliation': 'Departments of Neuroanaesthesia and Neurocritical Care.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000595']
1377,31092152,Estimated treatment effect of ticagrelor versus aspirin by investigator-assessed events compared with judgement by an independent event adjudication committee in the SOCRATES trial.,"BACKGROUND
Adjudication of endpoints is a standard procedure in cardiovascular clinical trials. However, several studies indicate that the benefit of adjudication in estimating treatment effect may be limited.
AIMS
This post hoc analysis of SOCRATES (NCT01994720) compared the treatment effects and investigated the agreement of clinical event assessment by site investigators and independent adjudicators.
METHODS
SOCRATES compared ticagrelor and aspirin in 13,199 patients with acute minor stroke or high-risk transient ischemic attack. The primary endpoint was stroke, myocardial infarction, or death. Stroke was the major component of the primary endpoint and a secondary endpoint. The endpoints were adjudicated by a blinded independent committee. We compared the treatment effect on the primary endpoint and stroke alone based on the investigators' and adjudicators' assessments, and investigated the agreement rate on the stroke endpoint and major hemorrhages.
RESULTS
The hazard ratios (95% confidence interval) for ticagrelor versus aspirin therapy for the primary endpoint were 0.89 (0.78-1.01) when calculated on adjudicator-assessed events and 0.88 (0.78-1.00) for investigator-assessed events. The hazard ratios (95% confidence intervals) for stroke were 0.86 (0.75-0.99) based on the adjudicators' diagnoses and 0.85 (0.75-0.97) based on the investigators' diagnoses. The overall agreement between adjudicator- and investigator-diagnosed stroke was 91%, and for major hemorrhages was 88%.
CONCLUSIONS
In SOCRATES, there was no clinically meaningful difference in the estimated treatment effect, on either the primary endpoint or stroke, by using investigator- or adjudicator-assessed events. Double-blind treatment outcome studies with stroke endpoints may not benefit from adjudication.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01994720.",2019,The hazard ratios (95% confidence intervals) for stroke were 0.86 (0.75-0.99) based on the adjudicators' diagnoses and 0.85 (0.75-0.97) based on the investigators' diagnoses.,"['13,199 patients with acute minor stroke or high-risk transient ischemic attack']","['ticagrelor versus aspirin', 'ticagrelor', 'ticagrelor and aspirin']","['major hemorrhages', 'stroke, myocardial infarction, or death', 'hazard ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",13199.0,0.482332,The hazard ratios (95% confidence intervals) for stroke were 0.86 (0.75-0.99) based on the adjudicators' diagnoses and 0.85 (0.75-0.97) based on the investigators' diagnoses.,"[{'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco, USA.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Denison', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Evans', 'Affiliation': 'Biostatistics Center, George Washington University, Washington, USA.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knutsson', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Centre, Bichat Hospital, Paris University, Paris, France.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University, Stanford, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ladenvall', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Ks Lawrence', 'Initials': 'KL', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine & Therapeutics, Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, University of Texas at Austin, Austin, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019851282']
1378,30794084,Low-Dose Testosterone and Evoked Resistance Exercise after Spinal Cord Injury on Cardio-Metabolic Risk Factors: An Open-Label Randomized Clinical Trial.,"The purpose of the work is to investigate the effects of low-dose testosterone replacement therapy (TRT) and evoked resistance training (RT) on body composition and metabolic variables after spinal cord injury (SCI). Twenty-two individuals with chronic motor complete SCI (ages 18-50 years) were randomly assigned to either TRT+RT ( n = 11) or TRT ( n = 11) for 16 weeks following a 4 -week delayed entry period. TRT+RT men underwent twice weekly progressive RT using electrical stimulation with ankle weights. TRT was administered via testosterone patches (2-6 mg/day). Body composition was tested using anthropometrics, dual energy x-ray absorptiometry, and magnetic resonance imaging. After an overnight fast, basal metabolic rate (BMR), lipid panel, serum testosterone, adiponectin, inflammatory and anabolic biomarkers (insulin-like growth factor-1 and insulin-like growth factor-binding protein 3 [IGFBP-3]), glucose effectiveness (Sg), and insulin sensitivity (Si) were measured. Total body lean mass (LM; 2.7 kg, p < 0.0001), whole muscle ( p < 0.0001), and whole muscle knee extensor cross-sectional areas (CSAs; p < 0.0001) increased in the TRT+RT group, with no changes in the TRT group. Visceral adiposity decreased ( p = 0.049) in the TRT group, with a trend in the TRT+RT ( p = 0.07) group. There was a trend ( p = 0.050) of a 14-17% increase in BMR following TRT+RT. Sg showed a trend ( p = 0.07) to improvement by 28.5-31.5% following both interventions. IGFBP-3 increased ( p = 0.0001) while IL-6 decreased ( p = 0.039) following both interventions, and TRT+RT suppressed adiponectin ( p = 0.024). TRT+RT resulted in an increase in LM and whole thigh and knee extensor muscle CSAs, with an increase in BMR and suppressed adiponectin. Low-dose TRT may mediate modest effects on visceral adipose tissue, Sg, IGFBP-3, and IL-6, independent of changes in LM.",2019,"IGFBP-3 increased (p = 0.0001) while IL-6 decreased (p = 0.039) following both interventions, and TRT+RT suppressed adiponectin (p = 0.024).","['after Spinal Cord Injury on Cardio-Metabolic Risk Factors', 'Twenty-two individuals with chronic motor complete SCI (ages 18-50 years', 'after spinal cord injury (SCI']","['TRT', 'TRT+RT', 'low-dose testosterone replacement therapy (TRT) and evoked resistance training (RT', 'Low-Dose Testosterone and Evoked Resistance Exercise', 'TRT was administered via testosterone patches']","['Body composition', 'whole muscle knee extensor cross-sectional areas', 'basal metabolic rate (BMR), lipid panel, serum testosterone, adiponectin, inflammatory and anabolic biomarkers (insulin-like growth factor-1 and insulin-like growth factor-binding protein 3 [IGFBP-3]), glucose effectiveness (Sg), and insulin sensitivity (Si', 'visceral adipose tissue, Sg, IGFBP-3, and IL-6', 'TRT+RT suppressed adiponectin', 'body composition and metabolic variables', 'BMR and suppressed adiponectin', 'IL-6', 'IGFBP-3', 'Total body lean mass', 'BMR', 'LM and whole thigh and knee extensor muscle CSAs', 'Visceral adiposity']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate (observable entity)'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'IGF-Binding Protein 3'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}]",22.0,0.0758576,"IGFBP-3 increased (p = 0.0001) while IL-6 decreased (p = 0.039) following both interventions, and TRT+RT suppressed adiponectin (p = 0.024).","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}, {'ForeName': 'Ranjodh', 'Initials': 'R', 'LastName': 'Gill', 'Affiliation': 'Endocrinology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gater', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Lavis', 'Affiliation': 'Spinal Cord Injury and Disorders Center, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cardozo', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, New York.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Service, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.'}]",Journal of neurotrauma,['10.1089/neu.2018.6136']
1379,31887222,Treatment effect of oil-based contrast is related to experienced pain at HSG: a post-hoc analysis of the randomised H2Oil study.,"STUDY QUESTION
Does pain or volume of used contrast medium impact the effectiveness of oil-based contrast during hysterosalpingography (HSG)?
SUMMARY ANSWER
In women who report moderate to severe pain during HSG, the use of oil-based contrast resulted in more ongoing pregnancies compared to the use of water-based contrast, whereas in women who reported mild or no pain, no difference in ongoing pregnancies was found.
WHAT IS KNOWN ALREADY
We recently showed that in infertile women undergoing HSG, the use of oil-based contrast results in more ongoing pregnancies within 6 months as compared to the use of water-based contrast. However, the underlying mechanism of this fertility-enhancing effect remains unclear.
STUDY DESIGN, SIZE, DURATION
We performed a post-hoc analysis of the H2Oil study, a multicentre randomised controlled trial (RCT) evaluating the therapeutic effect of oil- and water-based contrast at HSG. Here, we evaluated the impact of pain experienced at HSG and volume of used contrast media during HSG on ongoing pregnancy.
PARTICIPANTS/MATERIALS, SETTING, METHODS
In a subset of 400 participating women, pain during HSG by means of the Visual Analogue Scale (VAS) (range: 0.0-10.0 cm) was reported, while in 512 women, we registered the volume of used contrast (in millilitres). We used logistic regression analyses to assess whether pain and volume of used contrast media modified the effect of oil-based contrast on ongoing pregnancy rates. Data were analysed according to intention-to-treat principle.
MAIN RESULTS AND THE ROLE OF CHANCE
In 400 women in whom pain scores were reported, the overall median pain score was 5.0 (Interquartile range (IQR) 3.0-6.8) (oil group (n = 199) 4.8 (IQR 3.0-6.4); water group (n = 201) 5.0 (IQR 3.0-6.7); P-value 0.28). There was a significant interaction between pain (VAS ≤5 versus VAS ≥6) and the primary outcome ongoing pregnancy (P-value 0.047). In women experiencing pain (VAS ≥6), HSG with oil-based contrast resulted in better 6-month ongoing pregnancy rates compared to HSG with water-based contrast (49.4% versus 29.6%; RR 1.7; 95% CI, 1.1-2.5), while in women with a pain score ≤5, 6-month ongoing pregnancy rates were not significantly different between the use of oil- (28.8%) versus water-based contrast (29.2%) (RR 0.99; 95% CI, 0.66-1.5). In the 512 women in whom we recorded contrast, median volume was 9.0 ml (IQR 5.7-15.0) in the oil group versus 8.0 ml (IQR 5.9-13.0) in the water group, respectively (P-value 0.72). Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23).
LIMITATIONS, REASONS FOR CAUTION
This was a post-hoc analysis that should be considered as hypothesis generating. The RCT was restricted to infertile ovulatory women, younger than 39 years of age and with a low risk for tubal pathology. Therefore, our results should not be generalised to infertile women who do not share these features.
WIDER IMPLICATIONS OF THE FINDINGS
The underlying mechanism of the fertility-enhancing effect induced by HSG with the use of oil-based contrast remains unclear. However, these findings suggest a possible mechanistic pathway, that is increasing intrauterine pressure occurring prior to dislodging pregnancy hindering debris or mucus plugs from the proximal part of otherwise normal fallopian tubes. This information might help in the search of the underlying fertility-enhancing mechanism found by using oil-based contrast during HSG.
STUDY FUNDING/COMPETING INTEREST(S)
The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (AMC and VUmc) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and interpretation of the data. K.D. reports consultancy for Guerbet. H.V. reports consultancy fees from Ferring. C.B.L. reports speakers' fees from Ferring and research grants from Ferring, Merck and Guerbet. V.M. reports receiving travel and speakers fees as well as research grants from Guerbet. B.W.M. is supported by an NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. The other authors do not report conflict of interests.
TRIAL REGISTRATION NUMBER
The H2Oil study was registered at the Netherlands Trial Registry (NTR 3270).
TRIAL REGISTRATION DATE
1 February 2012.
DATE OF FIRST PATIENT’S ENROLMENT
3 February 2012.",2019,"Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23).
","['infertile women who do not share these features', 'infertile women undergoing', 'infertile ovulatory women, younger than 39\xa0years of age and with a low risk for tubal pathology', '400 participating women, pain during HSG by means of the Visual Analogue Scale (VAS) (range: 0.0-10.0 cm) was reported, while in 512 women']","['oil-based contrast', 'oil- and water-based contrast at HSG', 'oil-based contrast during hysterosalpingography (HSG', 'HSG']","['median volume', 'pain scores', 'pain score', 'overall median pain score', '6-month ongoing pregnancy rates', 'severe pain']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",512.0,0.128665,"Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Verhoeve', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, Amsterdam 1091 AC, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam 1105 AZ, The Netherlands.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Nap', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem 6815 AD, The Netherlands.'}, {'ForeName': 'J M J', 'Initials': 'JMJ', 'LastName': 'Smeenk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elisabeth-TweeSteden Hospital, Tilburg 5022 GC, The Netherlands.'}, {'ForeName': 'M A F', 'Initials': 'MAF', 'LastName': 'Traas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Hospital, Apeldoorn 7334 DZ, The Netherlands.'}, {'ForeName': 'H G M', 'Initials': 'HGM', 'LastName': 'Rijnsaardt-Lukassen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Albert Schweitzer Hospital, Dordrecht 3318 AT, The Netherlands.'}, {'ForeName': 'A J C M', 'Initials': 'AJCM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hospital Gelderse Vallei, Ede 6716 RP, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bourdrez', 'Affiliation': 'Department of Obstetrics and Gynaecology, VieCuri Medical Centre, Venlo 5912 BL, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's Hertogenbosch 5223 GZ, The Netherlands.""}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Sluijmer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Wilhelmina Hospital, Assen 9401 RK, The Netherlands.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Gijsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elkerliek Hospital, Helmond 5707 HA, The Netherlands.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC 3800, Australia.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez206']
1380,31411768,Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial.,"In the randomized, placebo-controlled, double-blind phase 3 ACTIVE study (NCT01343004), 18 months of abaloparatide 80 μg daily (subcutaneous injection) in postmenopausal women at risk of osteoporotic fracture significantly reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and significantly increased bone mineral density (BMD) versus placebo regardless of baseline risk factors. Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months. This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups. Baseline risk subgroups included BMD T-score at the lumbar spine, total hip, and femoral neck (≤ - 2.5 versus > - 2.5 and ≤ -3.0 versus > - 3.0), history of nonvertebral fracture (yes/no), prevalent vertebral fracture (yes/no), and age (<65 versus 65 to <75 versus ≥75 years). Forest plots display treatment effect. Treatment-by-subgroup interactions were tested using the Breslow-Day test, Cox proportional hazards model, and ANCOVA model. After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups. BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group. No clinically meaningful interaction between treatment assignment and any baseline risk variable was observed. The sequence of abaloparatide for 18 months followed by alendronate for up to 24 months appears to be an effective treatment option for a wide range of postmenopausal women at risk for osteoporotic fractures. © 2019 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc.",2019,"BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group.","['postmenopausal women at risk for osteoporotic fractures', 'Patients Treated With Abaloparatide Followed by', 'postmenopausal women at risk of osteoporotic fracture']","['abaloparatide/alendronate', 'placebo', 'alendronate', 'Alendronate', 'abaloparatide 80 μg daily (subcutaneous injection', 'sequential, open-label monotherapy with alendronate', 'placebo/alendronate', 'abaloparatide and placebo']","['relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures', 'BMD gains at the lumbar spine, total hip, and femoral neck', 'Fracture and Bone Mineral Density Response', 'BMD T-score at the lumbar spine, total hip, and femoral neck', 'bone mineral density (BMD', 'history of nonvertebral fracture', 'fracture risk reductions and BMD gains']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1272017', 'cui_str': 'At risk of osteoporotic fracture'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.115049,"BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group.","[{'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Zapalowski', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Ming-Yi', 'Initials': 'MY', 'LastName': 'Hu', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'School of Medicine, University of California at Davis, Sacramento, CA, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Singer', 'Affiliation': 'Medstar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Dore', 'Affiliation': 'David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3848']
1381,30922731,"Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer: an interim analysis of a multicentre, open-label, single-arm, phase 2 trial.","BACKGROUND
Lenvatinib is a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3, and other receptor tyrosine kinases. Pembrolizumab, an antibody targeting PD-1, has moderate efficacy in biomarker-unselected endometrial cancer. We aimed to assess the combination of lenvatinib plus pembrolizumab in patients with advanced endometrial carcinoma, after establishing the maximum tolerated dose in a phase 1b study.
METHODS
In this open-label, single-arm, phase 2 study done at 11 centres in the USA, eligible patients were aged 18 years or older and had metastatic endometrial cancer (unselected for microsatellite instability or PD-L1), had an Eastern Cooperative Oncology Group performance status of 0 or 1, had received no more than two previous systemic therapies, had measurable disease according to the immune-related Response Evaluation Criteria In Solid Tumors (irRECIST), and had a life expectancy of 12 weeks or longer. Patients received 20 mg oral lenvatinib daily plus 200 mg intravenous pembrolizumab every 3 weeks. Treatment continued until disease progression, development of unacceptable toxic effects, or withdrawal of consent. The primary endpoint of this interim analysis was the proportion of patients with an objective response at week 24 as assessed by investigators according to irRECIST in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT02501096.
FINDINGS
Between Sept 10, 2015, and July 24, 2017, 54 patients were enrolled, 53 of whom were included in the analysis. At the cutoff date for anti-tumour activity data (Dec 15, 2017), median study follow-up was 13·3 months (IQR 6·7-20·1). 21 (39·6% [95% CI 26·5-54·0]) patients had an objective response at week 24. Serious treatment-related adverse events occurred in 16 (30%) patients, and one treatment-related death was reported (intracranial haemorrhage). The most frequently reported any-grade treatment-related adverse events were hypertension (31 [58%]), fatigue (29 [55%]), diarrhoea (27 [51%]), and hypothyroidism (25 [47%]). The most common grade 3 treatment-related adverse events were hypertension (18 [34%]) and diarrhoea (four [8%]). No grade 4 treatment-related adverse events were reported. Five (9%) patients discontinued study treatment because of treatment-related adverse events.
INTERPRETATION
Lenvatinib plus pembrolizumab showed anti-tumour activity in patients with advanced recurrent endometrial cancer with a safety profile that was similar to those previously reported for lenvatinib and pembrolizumab monotherapies, apart from an increased frequency of hypothyroidism. Lenvatinib plus pembrolizumab could represent a new potential treatment option for this patient population, and is being investigated in a randomised phase 3 study.
FUNDING
Eisai and Merck.",2019,"Serious treatment-related adverse events occurred in 16 (30%) patients, and one treatment-related death was reported (intracranial haemorrhage).","['patients with advanced endometrial carcinoma, after establishing the maximum tolerated dose in a phase 1b study', 'patients with advanced endometrial cancer', '54 patients were enrolled, 53 of whom were included in the analysis', 'patients with advanced recurrent endometrial cancer', '11 centres in the USA, eligible patients were aged 18 years or older and had metastatic endometrial cancer (unselected for microsatellite instability or PD-L1), had an Eastern Cooperative Oncology Group performance status of 0 or 1, had received no more than two previous systemic therapies, had measurable disease according to the immune-related Response Evaluation Criteria In Solid Tumors (irRECIST), and had a life expectancy of 12 weeks or longer', 'Between Sept 10, 2015, and July 24, 2017']","['Pembrolizumab', 'lenvatinib plus pembrolizumab', 'Lenvatinib plus pembrolizumab', '20 mg oral lenvatinib daily plus 200 mg intravenous pembrolizumab']","['fatigue', 'proportion of patients with an objective response', 'adverse events', 'diarrhoea', 'objective response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0920269', 'cui_str': 'Microsatellite Instability'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",54.0,0.368983,"Serious treatment-related adverse events occurred in 16 (30%) patients, and one treatment-related death was reported (intracranial haemorrhage).","[{'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Makker', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: makkerV@mskcc.org.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Rasco', 'Affiliation': 'START, San Antonio, TX, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada and US Oncology Research, Las Vegas, NV, USA.'}, {'ForeName': 'Marcia S', 'Initials': 'MS', 'LastName': 'Brose', 'Affiliation': 'Perelman Center for Advanced Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Allen L', 'Initials': 'AL', 'LastName': 'Cohn', 'Affiliation': 'Rocky Mountain Cancer Center and US Oncology Research, Denver, CO, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mier', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Di Simone', 'Affiliation': 'Arizona Oncology Associates and US Oncology Research, Tucson, AZ, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hyman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Stepan', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Emmett V', 'Initials': 'EV', 'LastName': 'Schmidt', 'Affiliation': 'Merck, Kenilworth, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Sachdev', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shumaker', 'Affiliation': 'Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30020-8']
1382,30918861,Diets along with interval training regimes improves inflammatory & anti-inflammatory condition in obesity with type 2 diabetes subjects.,"Background
Different physical activities and diets change the regulation of inflammations in both type 2 diabetes (T2D) patients and obese individuals, but the effect of both (Physical activity and diet) on pro/anti-inflammations has remained unknown. We investigated pro/anti-inflammations control, cardiovascular function, and total physiological parameters before and after 24 weeks of low volume high intensity interval training (HIIT) on a cycle ergometer along with four dietary regimes in obesity with T2D patients.
Methods
33 non-active obesity T2D patients (BMI ≥ 30) midges (47 yrs. ± 5) were volunteered to participate and randomly divided into three experimental( n = 11) [(1) LCD = low Carbohydrate Diet, (2) LFD = Low Fat Diet and (3) HFD = High Fat Diet)] and one control ( n = 9) [ND = normal diet] groups. The whole groups performed underwent 8-week dietary regimes and then performed 3 days/weeks (3 set 10 × 60 s) HIIT on a cycle ergometer for 12 weeks, which followed by a 4-week diet period again. Also, prior to and after 8 weeks diet-12 weeks High Intensity Interval Training (HIIT) and 4 weeks diet 2-h oral glucose tolerance test (OGTT), resting blood pressure, incremental maximal oxygen uptake (VO2peak) cycle ergometer test and blood sample was collected from the subjects in order to measure pro/anti-inflammatory cytokines (IL-6, TNF-α, leptin, resistin, adiponectin, and FGF21).
Results
After 24 weeks of intervention, the results indicated that the highest improvement in the percentage of changes in glucose happened in LCD (-34.76), insulin in ND (+16.43), cholesterol in LCD (-33.35), LDL in LFD (-9.14), HDL in LCD (+41.81), TG in LCD (-40.71), weight in LCD (-12.49) and HOMA-IR in HFD (-6.82). The results also indicated that after 24 weeks of HIIT and diet interventions, highest benefit percentage change IL-6, resistin and leptin occurred in LCD (-32.10, -28.29 and - 53.92, respectively), TNF-α, FGF21 and adiponectin in LFD (-48.06, +55.30 and + 42.32, respectively). However, these changes were observed in other groups.
Conclusions
These results demonstrated that HIIT along with low carbohydrate regimes improves overall cardiovascular parameters and reduce pro-inflammatory markers and increase anti-inflammatory markers in type 2 diabetic patients. Additionally, as with HIIT along with low carbohydrate, HIIT coupled with low fat would improve inflammation markers, though these effects were less significant. These findings suggest that HIIT along with low carbohydrate is a beneficial exercise and dietary strategy in T2D patients.",2018,"The results also indicated that after 24 weeks of HIIT and diet interventions, highest benefit percentage change IL-6, resistin and leptin occurred in LCD (-32.10, -28.29 and - 53.92, respectively), TNF-α, FGF21 and adiponectin in LFD (-48.06, +55.30 and + 42.32, respectively).","['T2D patients (BMI\u2009≥\u200930) midges (47\xa0yrs', 'type 2 diabetes (T2D) patients and obese individuals', 'Methods\n\n\n33 non-active obesity', '±\u20095) were volunteered to participate and randomly divided into three experimental( n \u2009=\u200911', 'T2D patients', 'type 2 diabetic patients', 'obesity with T2D patients', 'obesity with type 2 diabetes subjects']","['High Intensity Interval Training (HIIT) and 4\xa0weeks', 'low volume high intensity interval training (HIIT']","['overall cardiovascular parameters and reduce pro-inflammatory markers and increase anti-inflammatory markers', 'percentage of changes in glucose happened in LCD (-34.76), insulin in ND (+16.43), cholesterol in LCD (-33.35), LDL in LFD (-9.14), HDL in LCD (+41.81), TG in LCD (-40.71), weight in LCD (-12.49) and HOMA-IR', 'diet 2-h oral glucose tolerance test (OGTT), resting blood pressure, incremental maximal oxygen uptake (VO2peak) cycle ergometer test and blood sample', 'TNF-α, FGF21 and adiponectin in LFD', 'pro/anti-inflammatory cytokines (IL-6, TNF-α, leptin, resistin, adiponectin, and FGF21', 'inflammation markers', 'IL-6, resistin and leptin occurred in LCD', 'inflammatory & anti-inflammatory condition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026074', 'cui_str': 'Midge (organism)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0065190', 'cui_str': 'low density lipoprotein inhibitor'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.0129392,"The results also indicated that after 24 weeks of HIIT and diet interventions, highest benefit percentage change IL-6, resistin and leptin occurred in LCD (-32.10, -28.29 and - 53.92, respectively), TNF-α, FGF21 and adiponectin in LFD (-48.06, +55.30 and + 42.32, respectively).","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Asle Mohammadi Zadeh', 'Affiliation': '1Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Hezar Jerib Street, P.O. Box 81746-7344, Isfahan, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Kargarfard', 'Affiliation': '1Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Hezar Jerib Street, P.O. Box 81746-7344, Isfahan, Iran.'}, {'ForeName': 'Syed Mohamad', 'Initials': 'SM', 'LastName': 'Marandi', 'Affiliation': '1Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Hezar Jerib Street, P.O. Box 81746-7344, Isfahan, Iran.'}, {'ForeName': 'Abdolhamid', 'Initials': 'A', 'LastName': 'Habibi', 'Affiliation': '2Department of Physical Education and Sport Sciences, Shahid Chamran University, Ahwaz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-018-0368-0']
1383,29088393,"Exercise, Manual Therapy, and Booster Sessions in Knee Osteoarthritis: Cost-Effectiveness Analysis From a Multicenter Randomized Controlled Trial.",,2018,,['Knee Osteoarthritis'],"['Exercise, Manual Therapy, and Booster Sessions']",[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C1697762', 'cui_str': 'Booster'}]",[],,0.106947,,"[{'ForeName': 'Allyn M', 'Initials': 'AM', 'LastName': 'Bove', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, 100 Technology Drive, Suite 210, Pittsburgh PA 15219.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Smith', 'Affiliation': 'Section of Decision Sciences, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Bise', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Fritz', 'Affiliation': 'Department of Physical Therapy, College of Health, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Childs', 'Affiliation': 'Evidence in Motion, San Antonio, and Doctoral Program in Physical Therapy, Baylor University, Waco, Texas.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Brennan', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, Utah.'}, {'ForeName': 'J Haxby', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'G Kelley', 'Initials': 'GK', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh.'}]",Physical therapy,['10.1093/ptj/pzx104']
1384,30907230,Cost-Effectiveness of Erythropoietin in Traumatic Brain Injury: A Multinational Trial-Based Economic Analysis.,"The EPO-TBI multi-national randomized controlled trial found that erythropoietin (EPO), when compared to placebo, did not affect 6-month neurological outcome, but reduced illness severity-adjusted mortality in patients with traumatic brain injury (TBI), making the cost-effectiveness of EPO in TBI uncertain. The current study uses patient-level data from the EPO-TBI trial to evaluate the cost-effectiveness of EPO in patients with moderate or severe TBI from the healthcare payers' perspective. We addressed the issue of transferability in multi-national trials by estimating costs and effects for specific geographical regions of the study (Australia/New Zealand, Europe, and Saudi Arabia). Unadjusted mean quality-adjusted life-years (QALYs; 95% confidence interval [CI]) at 6 months were 0.027 (0.020-0.034; p < 0.001) higher in the EPO group, with an adjusted QALY increment of 0.014 (0.000-0.028; p = 0.04). Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144; p = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693; p = 0.64). For a willingness-to-pay threshold of $US50,000 per QALY, 71.8% of replications were considered cost-effective. Therefore, we did not find evidence that EPO was significantly cost-effective in the treatment of moderate or severe TBI at 6-month follow-up.",2019,"Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144; p = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693; p = 0.64).","['Traumatic Brain Injury', ""patients with moderate or severe TBI from the healthcare payers' perspective"", 'patients with traumatic brain injury (TBI']","['EPO', 'Erythropoietin', 'placebo', 'erythropoietin (EPO']","['baseline IMPACT-TBI score and regional heterogeneity', 'Mean unadjusted costs', 'Unadjusted mean quality-adjusted life-years (QALYs']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2348942', 'cui_str': 'Healthcare payer'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",,0.182648,"Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144; p = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693; p = 0.64).","[{'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Knott', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'French', 'Affiliation': 'Western Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Little', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Haddad', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Presneill', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'D James', 'Initials': 'DJ', 'LastName': 'Cooper', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Duranteau', 'Affiliation': ""Département d'Anesthésie-Réanimation, Hôpital de Bicêtre, Assistance Publique des Hopitaux de Paris, Hôpitaux Universitaires Paris-Sud, Université Paris-Sud, Paris, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Huet', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mak', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Vallance', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Varma', 'Affiliation': 'The Alfred, Melbourne, Victoria, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Wills', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}]",Journal of neurotrauma,['10.1089/neu.2018.6229']
1385,31860606,A single-dose of stellate ganglion block for the prevention of postoperative dysrhythmias in patients undergoing thoracoscopic surgery for cancer: A randomised controlled double-blind trial.,"BACKGROUND
New-onset arrhythmias and sleep disturbances are frequently observed during the postoperative period in patients undergoing thoracic surgery.
OBJECTIVE
We evaluated the effectiveness of a single-dose stellate ganglion block (SGB) to prevent the occurrence of arrhythmias in patients undergoing thoracic surgery for cancer.
DESIGN
Randomised controlled double-blind study.
SETTING
Single university hospital.
PATIENTS
Ninety patients with lung cancer or oesophagal cancer scheduled for elective video-assisted thoracoscopic surgery were randomly randomised into one of two equal groups (the SGB group and control group, n = 40 each).
INTERVENTIONS
Patients received a single dose of 5 ml of 0.5% ropivacaine during ultrasound-guided SGB before induction of general anaesthesia in the SGB group.
MAIN OUTCOME MEASURES
Holter ECG was continuously monitored during the first 48 postoperative hours, and sleep state was monitored during the first two postoperative nights.
RESULTS
The incidences of postoperative supraventricular tachycardias were lower in the SGB group compared with the control group during the first 48 postoperative hours; 11.6 (5/43) vs. 31.8% (14/44), respectively, P = 0.023 (odds ratio 0.28, 95% confidence interval 0.09 to 0.87). The SGB also prolonged the total sleep time and increased the sleep efficiency during the first two postoperative nights. The duration of stage N2 sleep was longer in the SGB group compared with the control group [28 (interquartile range, 14 to 58) to 94 (interquartile range, 69 to 113) min, P = 0.016] on the first postoperative night. There were no differences in the duration of stage N1 and N3 sleep (P = 0.180, 0.086, respectively) on the first postoperative night, and the duration of stage N1, N2 and N3 sleep (P = 0.194, 0.057, 0.405, respectively) on the second postoperative night between the groups.
CONCLUSION
A pre-operative SGB effectively prevented the occurrence of postoperative supraventricular tachycardias and improves the objective sleep quality in patients undergoing thoracic surgery for cancer.
TRIAL REGISTRATION NUMBER
ChiCTR-1900023064.",2020,"There were no differences in the duration of stage N1 and N3 sleep (P = 0.180, 0.086, respectively) on the first postoperative night, and the duration of stage N1, N2 and N3 sleep (P = 0.194, 0.057, 0.405, respectively) on the second postoperative night between the groups.
","['patients undergoing thoracoscopic surgery for cancer', 'Ninety patients with lung cancer or oesophagal cancer scheduled for', 'patients undergoing thoracic surgery', 'Single university hospital', 'patients undergoing thoracic surgery for cancer']","['single dose of 5\u200aml of 0.5% ropivacaine', 'elective video-assisted thoracoscopic surgery', 'SGB group and control group, n\u200a=\u200a40 each', 'single-dose stellate ganglion block (SGB', 'stellate ganglion block']","['sleep efficiency', 'incidences of postoperative supraventricular tachycardias', 'duration of stage N2 sleep', 'Holter ECG was continuously monitored during the first 48 postoperative hours, and sleep state', 'duration of stage N1 and N3 sleep', 'total sleep time', 'duration of stage N1, N2 and N3 sleep', 'objective sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038246', 'cui_str': 'Cervicothoracic Ganglion'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4704917', 'cui_str': 'NREM Stage 2'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",90.0,0.152478,"There were no differences in the duration of stage N1 and N3 sleep (P = 0.180, 0.086, respectively) on the first postoperative night, and the duration of stage N1, N2 and N3 sleep (P = 0.194, 0.057, 0.405, respectively) on the second postoperative night between the groups.
","[{'ForeName': 'Cai-Neng', 'Initials': 'CN', 'LastName': 'Wu', 'Affiliation': ""From the Department of Anaesthesiology, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou (C-NW, W-HM), Department of Anesthesiology, Peking University Shenzhen Hospital, Shenzhen (W-HW), Department of Anesthesiology, Guangdong Provincial People's Hospital (D-NY), Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou University of Chinese Medicine (C-HS) and Department of Cardiovascular Pharmacology, School of Pharmacological Science, Southern Medical University, Guangzhou, China (YC).""}, {'ForeName': 'Xin-Hai', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Dong-Nan', 'Initials': 'DN', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Wu-Hua', 'Initials': 'WH', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Chun-Hui', 'Initials': 'CH', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001137']
1386,30852235,Central and Peripheral Determinants of Exercise Capacity in Heart Failure Patients With Preserved Ejection Fraction.,"OBJECTIVES
This study sought to discern which central (e.g., heart rate, stroke volume [SV], filling pressure) and peripheral factors (e.g., oxygen use by skeletal muscle, body mass index [BMI]) during exercise were most strongly associated with the presence of heart failure and preserved ejection fraction (HFpEF) as compared with healthy control subjects exercising at the same workload.
BACKGROUND
The underlying mechanisms limiting exercise capacity in patients with HFpEF are not fully understood.
METHODS
In patients with HFpEF (n = 108), the hemodynamic response at peak exercise was measured using right-sided heart catheterization and was compared with that in healthy control subjects (n = 42) at matched workloads to reveal hemodynamic differences that were not attributable to the workload performed. The patients studied were prospectively included in the REDUCE-LAP HF (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) trials and HemReX (Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans) study. Univariable and multivariable logistic regression models were used to analyze variables associated with HFpEF versus control subjects.
RESULTS
Compared with healthy control subjects, pulmonary capillary wedge pressure (PCWP) and SV were the only independent hemodynamic variables that were associated with HFpEF, a finding explaining 66% (p < 0.0001) of the difference between the groups. When relevant baseline characteristics were added to the base model, only BMI emerged as an additional independent variable, in total explaining of 90% of the differences between groups (p < 0.0001): PCWP (47%), BMI (31%), and SV (12%).
CONCLUSIONS
The study identified 3 key variables (PCWP, BMI, and SV) that independently correlate with the presence of patients with HFpEF compared with healthy control subjects exercising at the same workload. Therapies that decrease left-sided heart filling pressures could improve exercise capacity and possibly prognosis.",2019,"Compared with healthy control subjects, pulmonary capillary wedge pressure (PCWP) and SV were the only independent hemodynamic variables that were associated with HFpEF, a finding explaining 66% (p < 0.0001) of the difference between the groups.","['patients with HFpEF', 'Heart Failure Patients With Preserved Ejection Fraction', 'Patients With Heart Failure) trials and HemReX (Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans) study']",[],"['hemodynamic response at peak exercise', 'pulmonary capillary wedge pressure (PCWP) and SV', 'BMI', 'heart rate, stroke volume [SV], filling pressure) and peripheral factors (e.g., oxygen use by skeletal muscle, body mass index [BMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086879', 'cui_str': 'Pulmonary Capillary Wedge Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0305348,"Compared with healthy control subjects, pulmonary capillary wedge pressure (PCWP) and SV were the only independent hemodynamic variables that were associated with HFpEF, a finding explaining 66% (p < 0.0001) of the difference between the groups.","[{'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Wolsk', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. Electronic address: wolsk@dadlnet.dk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaye', 'Affiliation': 'Baker IDI Heart and Diabetes Research Institute, Melbourne, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Komtebedde', 'Affiliation': 'DC Devices, Boston, Massachusetts.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic and Foundation, Rochester, Minnesota.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burkhoff', 'Affiliation': 'Cardiovascular Research Foundation, Orangeburg, New York.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Singapore, Singapore; Duke-National University of Singapore, Singapore; Department of Cardiology, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'National Heart Centre Singapore, Singapore, Singapore; Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Medical University and Centre for Heart Diseases, Military Hospital, Wrocław, Poland.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.01.006']
1387,30707360,Live birth rates after different endometrial preparation methods in frozen cleavage-stage embryo transfer cycles: a randomized controlled trial.,"PURPOSE
This study aimed to compare the clinical outcomes in different endometrial preparation methods prior to frozen embryo transfer (FET) in women with normal menstrual cycles.
METHODS
A total of 471 eligible patients were randomly allocated into four groups of endometrial preparation prior to FET: natural cycle with spontaneous ovulation (n = 120), natural cycle with human chorionic gonadotropin (hCG) for ovulation induction (n = 117), hormone replacement cycle (HRC) (n = 113) and HRC with pre-treatment with GnRH-a (n = 121). Natural cycle with hCG also received hCG in luteal phase. The primary outcome was live birth rate. The secondary outcomes included implantation, biochemical and clinical pregnancy, ongoing pregnancy, and late miscarriage rates. Data analysis included t test, ANOVA and χ 2 .
RESULTS
There were no statistically significant differences in the mean age (p = 0.31), duration (p = 0.43) and cause of infertility (p = 0.77) and the number (p = 0.33) and quality (p = 0.21) of embryos transferred between the groups. No significant differences regarding the implantation rates per embryo transfer (p = 0.97) and biochemical pregnancy rates (p = 0.90) were observed between the groups. The rates of clinical pregnancy were 34.2%, 32.5%, 31% and 36.4% in the natural cycle, natural with hCG, HRC and HRC with GnRH-a groups, respectively (p = 0.83). Ongoing pregnancy (p = 0.89) and miscarriage (p = 0.33) rates were comparable between groups. The rate of live birth was 30.8% in the natural group, 30% in the natural with hCG, 27.4% in the HRC and 31.4% in the HRC with GnRH-a groups (p = 0.91).
CONCLUSION
Four different types of endometrial preparation methods for FET cycles appear to be equally effective in terms of implantation, pregnancy, miscarriage and live birth rates in women with normal menstrual cycles.
CLINICAL TRIAL REGISTRATION NUMBER
NCT02251925.",2019,"Four different types of endometrial preparation methods for FET cycles appear to be equally effective in terms of implantation, pregnancy, miscarriage and live birth rates in women with normal menstrual cycles.
","['471 eligible patients', 'frozen cleavage-stage embryo transfer cycles', 'women with normal menstrual cycles']","['endometrial preparation prior to FET: natural cycle with spontaneous ovulation (n\u2009=\u2009120), natural cycle with human\xa0chorionic\xa0gonadotropin\xa0(hCG) for ovulation induction (n\u2009=\u2009117), hormone replacement cycle (HRC) (n\u2009=\u2009113) and HRC with pre-treatment with GnRH-a', 'frozen embryo transfer (FET', 'hCG']","['rates of clinical pregnancy', 'Live birth rates', 'miscarriage', 'live birth rate', 'rate of live birth', 'implantation rates per embryo transfer', 'implantation, biochemical and clinical pregnancy, ongoing pregnancy, and late miscarriage rates', 'cause of infertility', 'implantation, pregnancy, miscarriage and live birth rates', 'biochemical pregnancy rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}]","[{'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C0029967', 'cui_str': 'Ovulation Induction'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer (procedure)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C4324509', 'cui_str': 'Late miscarriage'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy (finding)'}]",471.0,0.371999,"Four different types of endometrial preparation methods for FET cycles appear to be equally effective in terms of implantation, pregnancy, miscarriage and live birth rates in women with normal menstrual cycles.
","[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Madani', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, No 12, East Hafez Avenue, Banihashem Street, Resalat Highway, P.O Box: 19395-4644, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ramezanali', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, No 12, East Hafez Avenue, Banihashem Street, Resalat Highway, P.O Box: 19395-4644, Tehran, Iran.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Yahyaei', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, No 12, East Hafez Avenue, Banihashem Street, Resalat Highway, P.O Box: 19395-4644, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hasani', 'Affiliation': 'Department of Embryology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Bagheri Lankarani', 'Affiliation': 'Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Mohammadi Yeganeh', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, No 12, East Hafez Avenue, Banihashem Street, Resalat Highway, P.O Box: 19395-4644, Tehran, Iran. ladankh2004@yahoo.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05062-7']
1388,31887225,"A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 12-week efficacy, safety and speed of response from a randomized, double-blinded trial.","BACKGROUND
Patients with psoriasis value rapid and complete skin clearance. No head-to-head studies have focused on early responses to interleukin (IL)-17 vs. IL-23 inhibitors.
OBJECTIVES
To compare early and complete skin clearance by the IL-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab.
METHODS
IXORA-R, a 24-week, randomized, double-blinded study, enrolled adults with moderate-to-severe plaque psoriasis [static Physician's Global Assessment of Disease (sPGA) score of ≥ 3, Psoriasis Area and Severity Index (PASI) ≥ 12, and ≥ 10% body surface area]. Patients were randomized (1 : 1) to receive the approved dose of subcutaneous ixekizumab or guselkumab. Primary end point was 100% improvement in PASI (PASI 100) at week 12. Major secondary end points included other levels of improved PASI and sPGA at different time points. Comparisons were made using the Cochran-Mantel-Haenszel test with a multiple testing strategy. Nonresponder imputation was used for missing data. After the completion of the study, the final secondary end point (PASI 100 at 24 weeks) and safety data through week 24 will be reported.
RESULTS
In total, 1027 patients were randomized. The primary end point PASI 100 at week 12 was met [215/520 ixekizumab (41%); 126/507 guselkumab (25%); P < 0·001]. All major secondary end points measured up to week 12 were met, including PASI 50 at week 1 and PASI 75 at week 2. Serious adverse event frequency was 3% for each group; no new safety signals were identified.
CONCLUSIONS
Ixekizumab was superior to guselkumab for rapidly improving signs and symptoms in patients with moderate-to-severe plaque psoriasis by week 12. Adverse events were similar to previous ixekizumab and guselkumab studies. Compared with the IL-23 inhibitor guselkumab, ixekizumab can offer complete skin clearance more rapidly to patients with moderate-to-severe plaque psoriasis. What's already known about this topic? Patients with plaque psoriasis desire both high levels of clearance and rapid onset of treatment effects. Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, has demonstrated greater and faster skin clearance than etanercept and ustekinumab, with consistent long-term efficacy, safety and durability of response. Clinical trial data and systematic reviews have suggested that IL-17 inhibitors can improve a patient's psoriasis more rapidly than IL-23 inhibitors. What does this study add? The head-to-head study design directly compares the efficacy and speed of response of ixekizumab and the IL-23 inhibitor guselkumab in moderate-to-severe plaque psoriasis. The primary end point was met, showing superiority of ixekizumab over guselkumab for achieving complete skin clearance at week 12. The safety profile of ixekizumab was consistent with previous studies. Ixekizumab can deliver patients complete skin clearance and improved quality of life more rapidly than guselkumab.",2020,"No head-to-head studies have focused on early responses to interleukin (IL)-17 versus IL-23 inhibitors.
","['Patients with psoriasis value rapid and complete skin clearance', 'patients with moderate-to-severe plaque psoriasis', 'Patients with Moderate-to-Severe Plaque Psoriasis', ""enrolled adults with moderate-to-severe plaque psoriasis (static Physician's Global Assessment of Disease [sPGA] score of ≥3, Psoriasis Area and Severity Index [PASI] ≥12, and ≥10% body surface area"", '1027 patients were randomised']","['Ixekizumab Versus Guselkumab', 'IL-23 inhibitor guselkumab, ixekizumab', 'subcutaneous ixekizumab or guselkumab', 'Ixekizumab']","['levels of improved PASI and sPGA', 'PASI', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1027.0,0.26019,"No head-to-head studies have focused on early responses to interleukin (IL)-17 versus IL-23 inhibitors.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Inc., Waterloo, Ontario, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jarell', 'Affiliation': 'Northeast Dermatology Associates, Portsmouth, NH, U.S.A.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, U.S.A.'}, {'ForeName': 'L K', 'Initials': 'LK', 'LastName': 'Ferris', 'Affiliation': 'Department of Dermatology, University of Pittsburgh, Pittsburgh, PA, U.S.A.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': 'Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tada', 'Affiliation': 'Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Lima', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Elmaraghy', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Renda', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, U.S.A.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.18851']
1389,30916379,Adalimumab medium-term dosing strategy in moderate-to-severe hidradenitis suppurativa: integrated results from the phase III randomized placebo-controlled PIONEER trials.,"BACKGROUND
Weekly adalimumab (Humira ® ) is approved for the treatment of hidradenitis suppurativa (HS) based on the 12-week placebo-controlled periods of the two phase III PIONEER trials.
OBJECTIVES
Using PIONEER integrated trial results, we aimed to evaluate the optimal medium-term adalimumab maintenance dosing strategy for moderate-to-severe HS.
METHODS
Each trial had two double-blind periods; 12-week Period A and 24-week Period B. Patients randomized to adalimumab 40 mg every week (ADAew) (Period A), were rerandomized in Period B to ADAew (ADAew/ew), ADA every other week (ADAew/eow), or placebo (ADAew/pbo). Placebo-randomized patients were reassigned in Period B to ADAew (PIONEER I) or placebo (PIONEER II). The primary outcome was HS Clinical Response (HiSCR). Patients who lost response during Period B were discontinued from the study and offered an option to enter the open-label extension (OLE) to receive ADAew. Results are reported across the two study periods, and data were combined from the two study periods and the OLE.
RESULTS
For week-12 HiSCR achievers, the HiSCR week-36 rate was 48·1% (ADAew/ew) vs. 46·2% (ADAew/eow) and 32·1% (ADAew/pbo). Combining (post hoc) these patients with week-12 partial responders further differentiated outcomes in Period B (ADAew/ew 55·7% vs. ADAew/eow 40·0% and ADAew/pbo 30·1%). Period-B adverse-event rates were ADAew/ew 59·6% vs. ADAew/eow 57·4% and ADAew/pbo 65·0%. One patient (ADAew/ew) reported a serious infection.
CONCLUSIONS
Weekly adalimumab treatment, effective throughout 36 weeks, was the optimal maintenance medium-term dosing regimen for this population. At least partial response after 12 weeks with continued weekly dosing had better outcomes than dose reduction or interruption. Patients who do not show at least a partial response to weekly adalimumab by week 12 are unlikely to benefit from continued therapy. No new safety risks were identified. What's already known about this topic? Hidradenitis suppurativa (HS) is a chronic inflammatory disease, commonly misinterpreted as an infection and treated with long-term antibiotic regimens or surgical incisions. Based on the chronicity of HS and the lack of evidence for efficacious and safe long-term HS treatments, it is important to evaluate medium- to long-term therapies for HS. Weekly adalimumab (Humira ® ) is approved for the treatment of moderate-to-severe HS based on the two phase III PIONEER trials. What does this study add? This study pooled data from the two PIONEER trials, providing a more robust assessment of outcomes. After at least partial treatment success with weekly adalimumab short-term therapy (12 weeks), continuing weekly dosing during the subsequent 24 weeks had better outcomes than dose reduction or treatment interruption. Patients who do not show at least a partial response to weekly adalimumab by week 12 are unlikely to benefit from continued therapy.",2019,Period-B adverse-event rates were ADAew/ew 59·6% versus ADAew/eow 57·4% and ADA/pbo 65·0%.,"['Moderate-to-Severe Hidradenitis Suppurativa', 'moderate-to-severe HS']","['Adalimumab Medium-Term Dosing Strategy', 'placebo', 'open-label extension (OLE) to receive ADAew', 'Placebo', 'adalimumab (Humira ® ', 'adalimumab', 'adalimumab 40 mg every-week (ADAew) (Period A), were re-randomized in Period B to ADAew (ADAew/ew), ADA every-other-week (ADAew/eow), or placebo (ADAew/pbo', 'ADAew']","['Period-B adverse-event rates', 'Hidradenitis Suppurativa Clinical Response (HiSCR: ≥50% reduction from baseline in total abscess and inflammatory nodule count [AN], with no increase in abscess or draining-fistula counts', 'safety profile', 'HiSCR week-36 rate', 'serious infection']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0162836', 'cui_str': 'Acne Inversa'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1171255', 'cui_str': 'Humira'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162836', 'cui_str': 'Acne Inversa'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.150075,Period-B adverse-event rates were ADAew/ew 59·6% versus ADAew/eow 57·4% and ADA/pbo 65·0%.,"[{'ForeName': 'G B E', 'Initials': 'GBE', 'LastName': 'Jemec', 'Affiliation': 'Department of Dermatology Zealand University Hospital, Health Sciences Faculty University of Copenhagen, Roskilde, Denmark.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Okun', 'Affiliation': 'Fort HealthCare, Fort Atkinson, WI, U.S.A.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Forman', 'Affiliation': 'Forward Clinical Trials, Tampa, FL, U.S.A.'}, {'ForeName': 'W P F', 'Initials': 'WPF', 'LastName': 'Gulliver', 'Affiliation': ""Memorial University of Newfoundland, St John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Prens', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Department of Dermatology, Venereology, and Allergology, University Medical Center Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, U.S.A.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc., North Chicago, IL, U.S.A.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'AbbVie Inc., North Chicago, IL, U.S.A.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'AbbVie Inc., North Chicago, IL, U.S.A.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Teixeira', 'Affiliation': 'AbbVie Inc., North Chicago, IL, U.S.A.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Kimball', 'Affiliation': 'Harvard Medical School and Beth Israel Deaconess Hospital, Boston, MA, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17919']
1390,30905495,"A randomized clinical trial comparing early active motion programs: Earlier hand function, TAM, and orthotic satisfaction with a relative motion extension program for zones V and VI extensor tendon repairs.","STUDY DESIGN
Randomized clinical trial with parallel groups.
INTRODUCTION
Early active mobilization programs are used after zones V and VI extensor tendon repairs; two programs used are relative motion extension (RME) orthosis and controlled active motion (CAM). Although no comparative studies exist, use of the RME orthosis has been reported to support earlier hand function.
PURPOSE OF THE STUDY
This randomized clinical trial investigated whether patients managed with an RME program would recover hand function earlier postoperatively than those managed with a CAM program.
METHODS
Forty-two participants with zones V-VI extensor tendon repairs were randomized into either a CAM or RME program. The Sollerman Hand Function Test (SHFT) was the primary outcome measure of hand function. Days to return to work, QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire, total active motion (TAM), grip strength, and patient satisfaction were the secondary measures of outcome.
RESULTS
The RME group demonstrated better results at four weeks for the SHFT score (P = .0073; 95% CI: -10.9, -1.8), QuickDASH score (P = .05; 95% CI: -0.05, 19.5), and TAM (P = .008; 95% CI: -65.4, -10.6). Days to return to work were similar between groups (P = .77; 95% CI: -28.1, 36.1). RME participants were more satisfied with the orthosis (P < .0001; 95% CI: 3.5, 8.4). No tendon ruptures occurred.
DISCUSSION
Participants managed using an RME program, and RME finger orthosis demonstrated significantly better early hand function, TAM, and orthosis satisfaction than those managed by the CAM program using a static wrist-hand-finger orthosis. This is likely due to the less restrictive design of the RME orthosis.
CONCLUSIONS
The RME program supports safe earlier recovery of hand function and motion when compared to a CAM program following repair of zones V and VI extensor tendons.",2020,"RME participants were more satisfied with the orthosis (P < .0001; 95% CI: 3.5, 8.4).","['patients managed with an RME program would recover hand function earlier postoperatively than those managed with a CAM program', 'Forty-two participants with zones V-VI extensor tendon repairs']","['TAM, and orthotic satisfaction with a relative motion extension program', 'CAM or RME program', 'RME']","['SHFT score', 'QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire, total active motion (TAM), grip strength, and patient satisfaction', 'QuickDASH score', 'early hand function, TAM, and orthosis satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0224849', 'cui_str': 'Structure of extensor tendon'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231481', 'cui_str': 'Active movement (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",42.0,0.0917648,"RME participants were more satisfied with the orthosis (P < .0001; 95% CI: 3.5, 8.4).","[{'ForeName': 'Shirley J F', 'Initials': 'SJF', 'LastName': 'Collocott', 'Affiliation': 'Department of Hand Therapy, Manukau SuperClinic, Counties Manukau Health, Auckland, New Zealand. Electronic address: collocotts@gmail.com.'}, {'ForeName': 'Edel', 'Initials': 'E', 'LastName': 'Kelly', 'Affiliation': 'School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Middlemore Hospital, Counties Manukau Health, Otahuhu, New Zealand.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Myhr', 'Affiliation': 'Department of Hand Therapy, Manukau SuperClinic, Counties Manukau Health, Auckland, New Zealand.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Hand Therapy, Manukau SuperClinic, Counties Manukau Health, Auckland, New Zealand.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ellis', 'Affiliation': 'Health and Rehabilitation Research Institute, School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2018.10.003']
1391,30945949,The Effect of Dietary Intervention Along with Nutritional Education on Reducing the Gastrointestinal Side Effects Caused by Chemotherapy Among Women with Breast Cancer.,"Gastrointestinal (GI) side effects caused by chemotherapy in women with breast cancer are common but poorly understood which might be controlled by nutritional intervention. Thus, the major aim of this study was to assess the effect of dietary intervention along with nutritional education on reducing these side effects. The present study is a single-center, single-controlled, and randomized trial. A total of 150 patients with breast cancer undergoing chemotherapy were randomly assigned into intervention group to receive dietary intervention and nutritional education ( n = 73) or control group ( n = 67) for 10 weeks, after their three sessions of chemotherapy. The primary endpoint was the GI symptoms after each session of chemotherapy that were measured by a designed questionnaire based on ROMIII questionnaire. The severity of GI side effects in the dietary intervention along with nutritional education was decreased significantly in the third session of chemotherapy compared to the first session, which include reflux disorder ( P = 0.05), anorexia ( P < 0.001), nausea ( P = 0.002), constipation ( P < 0.001), and diarrhea ( P < 0.001). Moreover, significant reductions were observed in the severity of GI side effects in the intervention group compared to control group after the third session ( P < 0.001). After adjusting the analysis for baseline values including age, job, education level, weight, and body mass index, significant changes were observed for GI side effects in the intervention group compared to the control group ( P < 0.001). This study showed beneficial effects of individualized dietary intervention along with nutritional education on reducing diarrhea, constipation, vomiting, and nausea in women with breast cancer during the chemotherapy.",2019,"The severity of GI side effects in the dietary intervention along with nutritional education was decreased significantly in the third session of chemotherapy compared to the first session, which include reflux disorder ( P = 0.05), anorexia ( P < 0.001), nausea ( P = 0.002), constipation ( P < 0.001), and diarrhea ( P < 0.001).","['women with breast cancer', 'Women with Breast Cancer', 'women with breast cancer during the chemotherapy', '150 patients with breast cancer undergoing chemotherapy']","['Dietary Intervention', 'dietary intervention', 'chemotherapy', 'dietary intervention and nutritional education ( n \u2009=\u200973) or control group', 'Chemotherapy', 'individualized dietary intervention']","['ROMIII questionnaire', 'GI side effects', 'diarrhea, constipation, vomiting, and nausea', 'constipation', 'anorexia', 'reflux disorder', 'severity of GI side effects', 'diarrhea', 'nausea', 'GI symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",150.0,0.0294645,"The severity of GI side effects in the dietary intervention along with nutritional education was decreased significantly in the third session of chemotherapy compared to the first session, which include reflux disorder ( P = 0.05), anorexia ( P < 0.001), nausea ( P = 0.002), constipation ( P < 0.001), and diarrhea ( P < 0.001).","[{'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Abdollahi', 'Affiliation': 'a Faculty of Nutrition School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Najafi', 'Affiliation': 'b Breast Disease Department , Motamed Cancer Institute, ACER , Tehran , Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Razmpoosh', 'Affiliation': 'c Nutrition and Food Security Research Center , Shahid Sadoughi University of Medical Sciences , Yazd , Iran.'}, {'ForeName': 'Raheleh Shokouhi', 'Initials': 'RS', 'LastName': 'Shoormasti', 'Affiliation': 'e Immunology, Asthma and Allergy Research Institute , Tehran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'f Department of Quality of Life, Breast Cancer Research Center, Motamed Cancer Institute, ACECR , Tehran , Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Raji Lahiji', 'Affiliation': 'a Faculty of Nutrition School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Chamari', 'Affiliation': 'g Department of Community Nutrition, School of Nutritional Sciences and Dietetics , Tehran University of Medical Science , Tehran , Iran.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Asgari', 'Affiliation': 'h Food Security Research Center, School of Nutrition and Food Sciences , Isfahan University of Medical Sciences , Isfahan , Iran.'}, {'ForeName': 'Elhameh', 'Initials': 'E', 'LastName': 'Cheshmazar', 'Affiliation': 'a Faculty of Nutrition School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'a Faculty of Nutrition School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}]",Nutrition and cancer,['10.1080/01635581.2019.1590608']
1392,30893284,Intubating Laryngeal Mask Airway-assisted Flexible Bronchoscopic Intubation Is Associated With Reduced Cervical Spine Motion When Compared With C-MAC Video Laryngoscopy-guided Intubation: A Prospective Randomized Cross Over Trial.,"BACKGROUND
In the evolving research into cervical spine mechanics during airway intervention, new devices are being constantly added to the armamentarium of anesthesiologists. In this study we compared cervical spine movement during orotracheal intubation using an intubating laryngeal mask airway (LMA Fastrach) assisted flexible bronchoscope or video laryngoscope.
MATERIALS AND METHODS
In total, 40 consenting patients without history of abnormalities of cervical spine and planned for elective neuroradiologic interventions in the angiography suite were enrolled in this randomized crossover trial. Every patient was subjected to LMA Fastrach-guided flexible bronchoscopic as well as video laryngoscopy guided intubation. Cervical spine motion at the occipital bone, C1-C5 vertebrae, the occiput-C1, C1-C2, C2-C3 and C4-C5 junctions was investigated using continuous fluoroscopy during intubation. The primary outcome of the study was combined craniocervical motion from occiput to C5 between the 2 intubation techniques.
RESULTS
There was less (62%) combined craniocervical movement from occiput to C5 during the LMA Fastrach-flexible bronchoscopy-guided technique as compared with video laryngoscopy-guided intubation (17.55±14.23 vs. 28.95±11.58 degrees, respectively; P<0.001). The LMA Fastrach flexible bronchoscopy-guided technique also produced significantly less movement as compared to the video laryngoscope at the occiput-C1 (9.75±8.59 vs. 15.00±10.48 degrees; P=0.000) and C1-C2 level (3.95±7.51 vs. 7.53±9.1 degrees; P=0.003).
CONCLUSIONS
There was significantly less movement in the craniocervical and upper cervical spine during LMA Fastrach assisted flexible bronchoscopic intubation compared to video laryngoscopic intubation.",2020,There was significantly less movement in the craniocervical and upper cervical spine during LMA Fastrach assisted flexible bronchoscopic intubation compared to video laryngoscopic intubation.,['40 consenting patients without history of abnormalities of cervical spine and planned for elective neuroradiologic interventions in the angiography suite'],"['LMA Fastrach assisted flexible bronchoscopic intubation', 'orotracheal intubation using an intubating laryngeal mask airway (LMA Fastrach) assisted flexible bronchoscope or video laryngoscope', 'Intubating Laryngeal Mask Airway-assisted Flexible Bronchoscopic Intubation', 'C-MAC Video Laryngoscopy-guided Intubation']","['Cervical spine motion', 'C1-C2 level', 'combined craniocervical motion from occiput to C5 between the 2 intubation techniques', 'craniocervical and upper cervical spine', 'cervical spine movement', 'Cervical Spine Motion']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope (physical object)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1562228', 'cui_str': 'Intubation technique'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",40.0,0.157069,There was significantly less movement in the craniocervical and upper cervical spine during LMA Fastrach assisted flexible bronchoscopic intubation compared to video laryngoscopic intubation.,"[{'ForeName': 'Amlan', 'Initials': 'A', 'LastName': 'Swain', 'Affiliation': 'Department of Anaesthesia and Critical Care, Tata Main Hospital, Jamshedpur.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Bhagat', 'Affiliation': 'Department of Anaesthesia and Intensive Care.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Radiodiagnosis and Imaging.'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Salunke', 'Affiliation': 'Neurosurgery, PGIMER.'}, {'ForeName': 'Nidhi B', 'Initials': 'NB', 'LastName': 'Panda', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Seelora', 'Initials': 'S', 'LastName': 'Sahu', 'Affiliation': 'Department of Anaesthesia and Critical Care, Tata Main Hospital, Jamshedpur.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000583']
1393,31709910,Supporting Our Lifelong Engagement: Mothers and Teens Exercising ( SOLE MATES ); a feasibility trial.,"This study aimed to examine the feasibility of the Supporting Our Lifelong Engagement; Mothers and Teens Exercising ( SOLE MATES ) program. SOLE MATES , a single-arm six-week feasibility trial, comprised six face-to-face sessions. Participants were mothers (n = 27) with daughters (n = 31) aged 12-16 years. Data were collected in Ireland between January 2018 and March 2018. Feasibility benchmarks examined recruitment, data collection, acceptability, resources and participant responses. The primary outcome was daughters' step counts, measured via sealed pedometer for seven consecutive days at baseline and six weeks. Secondary outcomes included mothers' step counts, measures of communication, co-participation in activity, health-related quality of life and parenting practices. Feasibility benchmarks were reached or exceeded, except for retention. Eligibility rates were 93.4%, and baseline activity levels were low. Program content, measures and facilitators were acceptable, demonstrated through a mean score of 4.14 (SD 0.3) on a 5-point Likert Scale. Daily steps increased in mothers (2,875 increase, p = .009) and daughters (1,393 increase, p = .007). Positive feasibility metrics demonstrated the program's appeal. Participant responses for outcome measures also indicated program success. However, the relatively homogenous sample and relatively poor initial participation rate were study limitations. The intervention should be evaluated in a randomized controlled trial.",2020,"Daily steps increased in mothers (2,875 increase, p = .009) and daughters (1,393 increase, p = .007).",['Participants were mothers (n\xa0=\xa027) with daughters (n\xa0=\xa031) aged 12-16\xa0years'],[],"['5-point Likert Scale', ""daughters' step counts, measured via sealed pedometer"", ""mothers' step counts, measures of communication, co-participation in activity, health-related quality of life and parenting practices"", 'Feasibility benchmarks examined recruitment, data collection, acceptability, resources and participant responses', 'Feasibility benchmarks', 'baseline activity levels', 'Eligibility rates']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1393.0,0.0401644,"Daily steps increased in mothers (2,875 increase, p = .009) and daughters (1,393 increase, p = .007).","[{'ForeName': 'Méabh', 'Initials': 'M', 'LastName': 'Corr', 'Affiliation': 'Department of Arts Education and Physical Education, Mary Immaculate College, University of Limerick , Limerick, Ireland.'}, {'ForeName': 'Jaimie', 'Initials': 'J', 'LastName': 'McMullen', 'Affiliation': 'School of Sport and Exercise Science, University of Northern Colorado , Greeley, Colorado, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Newcastle, Australia.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Barnes', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Newcastle, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Murtagh', 'Affiliation': 'Department of Arts Education and Physical Education, Mary Immaculate College, University of Limerick , Limerick, Ireland.'}]",Women & health,['10.1080/03630242.2019.1688446']
1394,31710176,Longitudinal study of the development of obstruent correctness from ages 3 to 5 years in 108 Danish children with unilateral cleft lip and palate: a sub-study within a multicentre randomized controlled trial.,"BACKGROUND
Speech-sound development in preschoolers with unilateral cleft lip and palate (UCLP) as a group is delayed/disordered, and obstruents comprise the most vulnerable sound class.
AIMS
To evaluate the development of obstruent correctness (PCC-obs) and error types (cleft speech characteristics (CSCs) and developmental speech characteristics (DSCs)) from ages 3-5 and to investigate possible predictors (error types, velopharyngeal dysfunction (VPD) and gender) of PCC-obs at age 5 in two groups of children with UCLP.
METHODS & PROCEDURES
Subgroup analysis was conducted within a multicentre randomized controlled trial (RCT) of primary surgery (Scandcleft Project). A total of 125 Danish children with UCLP received lip and soft palate repair around 4 months of age and early hard palate closure at 12 months (EHPC group) or late hard palate closure at 36 months (LHPC group). Audio and video recordings of a naming test were available for 108 children at ages 3 and 5, and recordings were transcribed phonetically by blinded raters.
OUTCOMES & RESULTS
PCC-obs scores increased significantly from ages 3-5 in both groups, but with small effect sizes in the EHPC group that had higher scores at age 3 than the LHPC group. DSCs decreased in both groups whereas CSCs only decreased in the LHPC group that had more CSCs at age 3 than the EHPC group. The frequency of CSCs at age 3 was a significant predictor of PCC-obs scores at age 5 in both groups. DSCs significantly improved the logistic regression model in the EHPC group, whereas VPD and gender did not significantly improve the model in either group.
CONCLUSIONS & IMPLICATIONS
Although PCC-obs developed significantly from ages 3 to 5, children with UCLP as a group did not catch up to typically developing Danish children at age 5. Furthermore, the LHPC group at age 5 did not reach the 3-year level of the EHPC group, which means that delaying hard palate closure until age 3 is detrimental to obstruent development. Both CSCs and DSCs at age 3 were important predictors of PCC-obs at age 5 and should be considered when determining need for intervention.",2020,The frequency of CSCs at age 3 was a significant predictor of PCC-obs scores at age 5 in both groups.,"['125 Danish children with UCLP received lip and soft palate repair around 4 months of age and early hard palate closure at 12 months (EHPC group) or late hard palate closure at 36 months (LHPC group', '108 children at ages 3 and 5, and recordings were transcribed phonetically by blinded raters', 'ages 3 to 5 years in 108 Danish children with unilateral cleft lip and palate', 'ages 3-5 and to investigate possible predictors (error types, velopharyngeal dysfunction (VPD) and gender) of PCC-obs at age 5 in two groups of children with UCLP', 'preschoolers with unilateral cleft lip and palate (UCLP']","['UCLP', 'EHPC', 'LHPC']","['PCC-obs scores', 'DSCs', 'obstruent correctness (PCC-obs) and error types (cleft speech characteristics (CSCs) and developmental speech characteristics (DSCs', 'frequency of CSCs', 'logistic regression model', 'CSCs']","[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C1536072', 'cui_str': 'Soft palate repair'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}]",[],"[{'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",108.0,0.0741961,The frequency of CSCs at age 3 was a significant predictor of PCC-obs scores at age 5 in both groups.,"[{'ForeName': 'Line Dahl', 'Initials': 'LD', 'LastName': 'Jørgensen', 'Affiliation': 'University of Copenhagen, Department of Nordic Studies and Linguistics, Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Willadsen', 'Affiliation': 'University of Copenhagen, Department of Nordic Studies and Linguistics, Copenhagen, Denmark.'}]",International journal of language & communication disorders,['10.1111/1460-6984.12508']
1395,31709969,Vitamin A intakes remain higher among intervention participants 3 years after a biofortification intervention in Mozambique.,"The Reaching End Users (REU) project introduced orange sweet potatoes (OSP) to farmers in northern Mozambique between 2006 and 2009, and the associated cluster randomised control trial found increased vitamin A intake among targeted children and women of child-bearing age and reduced prevalence of inadequate vitamin A intake. Yet little is known about whether successful agricultural-nutrition interventions have lasting effects. This study measures the lasting effects of the REU project, 3 years after the project ended, on vitamin A intake. To do so, dietary intake data were collected in the same thirty-six villages as the original study, focusing on both women of child-bearing age and children under 6 years old, the latter including both children who had been measured before and younger children (under 3 years old) in the same farmer groups. The dietary intake is then converted to micronutrient intake to compare treated households with control households. Vitamin A intake remains higher in treated villages than in control villages among both children under 3 years old, who had not been born when the original intervention ended, and mothers of child-bearing age. Differences in vitamin A intake can wholly be attributed to differences in OSP intake. Therefore, the REU project appears to have had lasting impacts on vitamin A intake beyond the intervention period. Had the vine retention component been enhanced, lasting impacts could have been even larger.",2019,"Vitamin A intake remains higher in treated villages than in control villages among both children under 3 years old, who had not been born when the original intervention ended, and mothers of child-bearing age.","['children under 3 years old, who had not been born when the original intervention ended, and mothers of child-bearing age', 'treated households with control households', 'same thirty-six villages as the original study, focusing on both women of child-bearing age and children under 6 years old, the latter including both children who had been measured before and younger children (under 3 years old) in the same farmer groups']",[],['vitamin A intake'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0221460', 'cui_str': 'Agricultural Workers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0564436', 'cui_str': 'Vitamin A intake (observable entity)'}]",,0.0309355,"Vitamin A intake remains higher in treated villages than in control villages among both children under 3 years old, who had not been born when the original intervention ended, and mothers of child-bearing age.","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'de Brauw', 'Affiliation': 'Markets, Trade, and Institutions Division, International Food Policy Research Institute, Washington, DC 20005, USA.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Moursi', 'Affiliation': 'FHI 360, Washington, DC 20009; Formerly HarvestPlus/International Food Policy Research Institute, Washington, DC 20005, USA.'}, {'ForeName': 'A Bernardinho', 'Initials': 'AB', 'LastName': 'Munhaua', 'Affiliation': 'MUVA, Monitoring, Evaluation, and Learning Department, Francisco Orlando Magumbwé Avenue, Maputo, Mozambique.'}]",The British journal of nutrition,['10.1017/S0007114519002162']
1396,31596612,Comparative Efficacy on Flexible Ureteroscopy Lithotripsy and Miniaturized Percutaneous Nephrolithotomy for the Treatment of Medium-Sized Lower-Pole Renal Calculi.,"Objective: To demonstrate the safety and efficacy of flexible ureteroscopy lithotripsy (FURL) and miniaturized percutaneous nephrolithotomy (MPCNL) through the comparative studies in treating medium-sized lower-pole renal calculi. Methods: Two hundred and twenty eligible patients with lower-pole renal calculi (1-2 cm) were enrolled and further randomly assigned into FURL group and MPCNL group. Patients' demographics, preoperative characteristics, intraoperative and postoperative complications, stone-free rate, and comfort and pain indicated by Bruggrmann Comfort Scale (BCS) and visual analog scale (VAS) were evaluated and recorded. Trauma index such as white blood cells, C-reactive protein (CRP), and interleukin (IL)-6 were also detected. Results: The stone-free rate and the operating time were comparable in FURL and MPCNL groups. Intraoperative and postoperative complication analysis showed that blood loss and hospital stay were significantly lower in the FURL group compared with MPCNL group. No significant difference in minor pelvic perforation, false passage, hemoglobin drop, persistent hematuria, ureteral perforation, moderate fever, urosepsis, and postoperative serum creatinine level was observed. However, as to comfort and pain indicated by BCS and VAS and stress indicated by CRP and IL-6, FURL was superior to MPCNL. Conclusion: FURL could be a better alternative surgical method to MPCNL with similar curative effect and less blood loss and hospital stay.",2019,FURL could be a better alternative surgical method to MPCNL with similar curative effect and less blood loss and hospital stay.,"['Medium-Sized Lower-Pole Renal Calculi', 'Two hundred and twenty eligible patients with lower-pole renal calculi (1-2\u2009cm']","['Flexible Ureteroscopy Lithotripsy and Miniaturized Percutaneous Nephrolithotomy', 'MPCNL', 'FURL group and MPCNL', 'flexible ureteroscopy lithotripsy (FURL) and miniaturized percutaneous nephrolithotomy (MPCNL', 'FURL']","['minor pelvic perforation, false passage, hemoglobin drop, persistent hematuria, ureteral perforation, moderate fever, urosepsis, and postoperative serum creatinine level', ""Patients' demographics, preoperative characteristics, intraoperative and postoperative complications, stone-free rate, and comfort and pain indicated by Bruggrmann Comfort Scale (BCS) and visual analog scale (VAS"", 'Trauma index such as white blood cells, C-reactive protein (CRP), and interleukin (IL)-6', 'blood loss and hospital stay', 'stone-free rate and the operating time', 'safety and efficacy']","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0337815', 'cui_str': 'Poles (ethnic group)'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0522566', 'cui_str': 'False passage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0559750', 'cui_str': 'Persistent hematuria (disorder)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0149801', 'cui_str': 'Sepsis due to urinary tract infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451546', 'cui_str': 'Trauma index (assessment scale)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",220.0,0.0363077,FURL could be a better alternative surgical method to MPCNL with similar curative effect and less blood loss and hospital stay.,"[{'ForeName': 'Lianchao', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Ningchen', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}]",Journal of endourology,['10.1089/end.2019.0504']
1397,30895296,Early goal-directed haemodynamic optimization of cerebral oxygenation in comatose survivors after cardiac arrest: the Neuroprotect post-cardiac arrest trial.,"AIMS
During the first 6-12 h of intensive care unit (ICU) stay, post-cardiac arrest (CA) patients treated with a mean arterial pressure (MAP) 65 mmHg target experience a drop of the cerebral oxygenation that may cause additional cerebral damage. Therefore, we investigated whether an early goal directed haemodynamic optimization strategy (EGDHO) (MAP 85-100 mmHg, SVO2 65-75%) is safe and could improve cerebral oxygenation, reduce anoxic brain damage, and improve outcome when compared with a MAP 65 mmHg strategy.
METHODS AND RESULTS
A total of 112 out-of-hospital CA patients were randomly assigned to EGDHO or MAP 65 mmHg strategies during the first 36 h of ICU stay. The primary outcome was the extent of anoxic brain damage as quantified by the percentage of voxels below an apparent diffusion coefficient (ADC) score of 650.10-6 mm2/s on diffusion weighted magnetic resonance imaging (at day 5 ± 2 post-CA). Main secondary outcome was favourable neurological outcome (CPC score 1-2) at 180 days. In patients assigned to EGDHO, MAP (P < 0.001), and cerebral oxygenation during the first 12 h of ICU stay (P = 0.04) were higher. However, the percentage of voxels below an ADC score of 650.10-6 mm2/s did not differ between both groups [16% vs. 12%, odds ratio 1.37, 95% confidence interval (CI) 0.95-0.98; P = 0.09]. Also, the number of patients with favourable neurological outcome at 180 days was similar (40% vs. 38%, odds ratio 0.98, 95% CI 0.41-2.33; P = 0.96). The number of serious adverse events was lower in patients assigned to EGDHO (P = 0.02).
CONCLUSION
Targeting a higher MAP in post-CA patients was safe and improved cerebral oxygenation but did not improve the extent of anoxic brain damage or neurological outcome.",2019,Targeting a higher MAP in post-CA patients was safe and improved cerebral oxygenation but did not improve the extent of anoxic brain damage or neurological outcome.,"['A total of 112 out-of-hospital CA patients', 'comatose survivors after cardiac arrest']",['cerebral oxygenation'],"['favourable neurological outcome (CPC score 1-2', 'percentage of voxels below an ADC score', 'safe and improved cerebral oxygenation', 'number of patients with favourable neurological outcome', 'number of serious adverse events', 'anoxic brain damage or neurological outcome', 'cerebral oxygenation', 'extent of anoxic brain damage as quantified by the percentage of voxels below an apparent diffusion coefficient (ADC) score', 'cerebral oxygenation, reduce anoxic brain damage']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}]",[],"[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003132', 'cui_str': 'Anoxic Encephalopathy'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.266085,Targeting a higher MAP in post-CA patients was safe and improved cerebral oxygenation but did not improve the extent of anoxic brain damage or neurological outcome.,"[{'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Ameloot', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Schiepse Bos 6, Genk, Belgium.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'De Deyne', 'Affiliation': 'Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium.'}, {'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Eertmans', 'Affiliation': 'Faculty of Medicine and Life Sciences, University Hasselt, Diepenbeek, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Ferdinande', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Schiepse Bos 6, Genk, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Dupont', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Schiepse Bos 6, Genk, Belgium.'}, {'ForeName': 'Pieter-Jan', 'Initials': 'PJ', 'LastName': 'Palmers', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Schiepse Bos 6, Genk, Belgium.'}, {'ForeName': 'Tibaut', 'Initials': 'T', 'LastName': 'Petit', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Schiepse Bos 6, Genk, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Nuyens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Schiepse Bos 6, Genk, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Maeremans', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Schiepse Bos 6, Genk, Belgium.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Vundelinckx', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Vanhaverbeke', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Peeters', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Demaerel', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lemmens', 'Affiliation': 'Department of Radiology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Dens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Schiepse Bos 6, Genk, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.'}]",European heart journal,['10.1093/eurheartj/ehz120']
1398,31707805,Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy Among Stented Patients With Atrial Fibrillation: Insights From the PIONEER AF-PCI Trial.,"BACKGROUND
Among stented patients with atrial fibrillation, double therapy with a novel oral anticoagulant plus single antiplatelet therapy (SAPT) reduces bleeding or cardiovascular rehospitalizations compared with a vitamin K antagonist (VKA) based triple therapy regimen. A recent study demonstrated that apixaban based double therapy reduced bleeding compared with VKA based double therapy. However, it remains unknown whether rivaroxaban based double therapy is superior to a VKA based double therapy.
METHODS
Patient with stented atrial fibrillation (n=2124) were randomized to 3 groups: rivaroxaban 15 mg od plus a P2Y 12 inhibitor (Group 1, n=709); rivaroxaban 2.5 mg bid plus dual antiplatelet therapy (DAPT; Group 2, n=709); and warfarin plus DAPT (Group 3, n=706). Before randomization, subjects were stratified according to a prespecified duration of DAPT (1, 6, or 12 months). After the prespecified DAPT duration, subjects in Group 2 were switched to rivaroxaban 15 mg plus low dose aspirin, and those in Group 3 were switched to VKA plus low dose aspirin. The Wei, Lin, and Weissfeld time to multiple events method was used to compare the occurrence of all bleeding and cardiovascular rehospitalizations among subjects on a novel oral anticoagulant versus VKA based double therapy.
RESULTS
A total of 906 subjects were prespecified to a 1 or 6 months DAPT duration and received at least one dose of study drug. Twenty subjects (3.3%) assigned to novel oral anticoagulant+SAPT, and 15 (5.1%) subjects assigned to VKA+SAPT experienced multiple rehospitalizations. In total, 124 (20.3%) events occurred among subjects on novel oral anticoagulant+SAPT compared with 87 (29.6%) among subjects on VKA+SAPT (hazard ratio=0.65 [95% CI, 0.45-0.93], P =0.008).
CONCLUSIONS
Among stented patients with atrial fibrillation, rivaroxaban plus SAPT was superior to warfarin plus SAPT in lowering total bleeding and cardiovascular rehospitalization.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01830543.",2019,"Among stented patients with atrial fibrillation, rivaroxaban plus SAPT was superior to warfarin plus SAPT in lowering total bleeding and cardiovascular rehospitalization.
","['Twenty subjects (3.3%) assigned to novel oral anticoagulant+SAPT, and 15 (5.1%) subjects assigned to', 'Patient with stented atrial fibrillation (n=2124', '906 subjects were prespecified to a 1 or 6 months DAPT duration and received at least one dose of study drug', 'stented patients with atrial fibrillation', 'Stented Patients With Atrial Fibrillation']","['warfarin plus SAPT', 'rivaroxaban', 'VKA plus low dose aspirin', 'warfarin plus DAPT', 'Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy', 'rivaroxaban plus SAPT', 'novel oral anticoagulant plus single antiplatelet therapy (SAPT', 'rivaroxaban 15 mg od plus a P2Y 12 inhibitor', 'rivaroxaban 15 mg plus low dose aspirin', 'rivaroxaban 2.5 mg bid plus dual antiplatelet therapy (DAPT', 'VKA+SAPT', 'vitamin K antagonist (VKA', 'apixaban']",['total bleeding and cardiovascular rehospitalization'],"[{'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C3248001', 'cui_str': 'rivaroxaban 15 MG [Xarelto]'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",906.0,0.102148,"Among stented patients with atrial fibrillation, rivaroxaban plus SAPT was superior to warfarin plus SAPT in lowering total bleeding and cardiovascular rehospitalization.
","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (M.K., M.K.Y., T.N., C.M.G.).'}, {'ForeName': 'Megan K', 'Initials': 'MK', 'LastName': 'Yee', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (M.K., M.K.Y., T.N., C.M.G.).'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, NY (R.M., J.L.H.).'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Nafee', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (M.K., M.K.Y., T.N., C.M.G.).'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Germany (C.B.).'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Halperin', 'Affiliation': 'Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, NY (R.M., J.L.H.).'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (E.D.P.).'}, {'ForeName': 'Freek W A', 'Initials': 'FWA', 'LastName': 'Verheugt', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands (F.W.A.V.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'Janssen Pharmaceuticals, Inc, Beerse, Belgium, Inc, Titusville, NJ (P.W.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van Eickels', 'Affiliation': 'Bayer Pharmaceuticals, Inc, Berlin, Germany (M.v.E.).'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Denmark (G.Y.H.L.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ (M.C.).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, United Kingdom (K.A.A.F.).'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (M.K., M.K.Y., T.N., C.M.G.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008160']
1399,31706830,Benefits of minimally-invasive surgery for sigmoid and rectal cancer in older adults compared with younger adults: Do older adults have the most to gain?,"INTRODUCTION
Randomized trials demonstrated oncologic safety and short-term benefits of laparoscopy. We investigated if the benefit of laparoscopy on short-term outcomes is greater for older adults compared with younger adults.
METHODS
We identified all older (≥70 years old) and younger (<70) adults with primary sigmoid and rectal cancer treated with resection between 2002 and 2018 from an institutional database. We compared 30-day postoperative outcomes using multivariable logistic regression with an interaction term between age group and surgical approach. Primary outcomes were death, major (Clavien-Dindo III-IV) and minor (Clavien-Dindo I-II) complications, and wound complications.
RESULTS
We included 792 patients, 293 (37%) older and 499 (63%) younger. Use of laparoscopy was similar between age groups: 120/293 (41%) older, 204/499 (41%) younger (p = .98). All patients had 30-day follow-up. Compared with open resection, minimally-invasive resection was associated with a greater reduction in deaths in older adults than in younger adults (absolute difference in older adults 7.0% less versus 2.1% less in younger adults; adjusted odds ratio [aOR] older 3.01, 95% confidence interval [CI] 1.31-7.33; aOR younger 0.31, 95% CI 0.05-1.24; interaction p = .01). Similarly, minimally-invasive resection was associated with a greater reduction in major complications in older adults than in younger adults (absolute difference in older adults 6.4% less versus 2.4% less in younger adults; aOR older 1.91, 95% CI 1.07-3.41; aOR younger 0.70, 95% CI 0.34-1.38; interaction p = .03).
CONCLUSIONS
Minimally-invasive compared with open surgery demonstrated a differential benefit on postoperative death and major complications between younger and older adults.",2020,"Compared with open resection, minimally-invasive resection was associated with a greater reduction in deaths in older adults than in younger adults (absolute difference in older adults 7.0% less versus 2.1% less in younger adults; adjusted odds ratio [aOR] older 3.01, 95% confidence interval [CI] 1.31-7.33; aOR younger 0.31, 95% CI 0.05-1.24; interaction p = .01).","['younger and older adults', 'all older (≥70\u202fyears old) and younger (<70) adults with primary sigmoid and rectal cancer treated with resection between 2002 and 2018 from an institutional database', 'older adults compared with younger adults', '792 patients, 293 (37%) older and 499 (63%) younger']","['Minimally-invasive compared with open surgery', 'minimally-invasive surgery', 'laparoscopy']","['major complications', 'deaths', 'death, major (Clavien-Dindo III-IV) and minor (Clavien-Dindo I-II) complications, and wound complications', 'postoperative death and major complications']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1096106'}, {'cui': 'C0277599', 'cui_str': 'Postoperative death (event)'}]",792.0,0.132276,"Compared with open resection, minimally-invasive resection was associated with a greater reduction in deaths in older adults than in younger adults (absolute difference in older adults 7.0% less versus 2.1% less in younger adults; adjusted odds ratio [aOR] older 3.01, 95% confidence interval [CI] 1.31-7.33; aOR younger 0.31, 95% CI 0.05-1.24; interaction p = .01).","[{'ForeName': 'Tyler R', 'Initials': 'TR', 'LastName': 'Chesney', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada; Division of General Surgery, University Health Network, Toronto, Ontario, Canada. Electronic address: tyler.chesney@mail.utoronto.ca.'}, {'ForeName': 'Humzah A', 'Initials': 'HA', 'LastName': 'Quereshy', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Draginov', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sami A', 'Initials': 'SA', 'LastName': 'Chadi', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada; Division of General Surgery, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Fayez A', 'Initials': 'FA', 'LastName': 'Quereshy', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada; Division of General Surgery, University Health Network, Toronto, Ontario, Canada.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2019.09.018']
1400,31707814,Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled trial.,"BACKGROUND
Few migraine preventive agents have been assessed in a pediatric population. We evaluated the safety and efficacy of cinnarizine and sodium valproate for migraine prophylaxis in children and adolescents.
METHODS
We carried out a randomized double-blind placebo-controlled trial in the Children's Medical Center and Sina hospital, Tehran, Iran. Eligible participants were randomly assigned in 1:1:1 ratio via interactive web response system to receive either cinnarizine, sodium valproate, or placebo. The primary endpoints were the mean change in frequency and intensity of migraine attacks from baseline to the last 4 weeks of trial. The secondary endpoint was the efficacy of each drug in the prevention of migraine. The drug was considered effective if it decreased migraine frequency by more than 50% in the double-blind phase compared with the baseline. Safety endpoint was adverse effects that were reported by children or their parents.
RESULTS
A total of 158 children participated. The frequency of migraine attacks significantly reduced compared to baseline in cinnarizine (difference: -8.0; 95% confidence interval (CI): -9.3 to -6.6), sodium valproate (difference: -8.3; 95% confidence interval: -9.3 to -7.2), and placebo (difference: -4.4; 95% confidence interval: -5.4 to -3.4) arms. The decrease was statistically greater in cinnarizine (difference: -3.6; 95% confidence interval: -5.5 to -1.6) and sodium valproate (difference: -3.9; 95% confidence interval: -5.8 to -1.9) arms, compared to placebo group. Children in all groups had significant reduction in intensity of episodes compared to baseline (cinnarizine: -4.6; 95% confidence interval: -5.2 to -4.0; sodium valproate: -4.0; 95% confidence interval: -4.8 to -3.3; placebo: -2.6; 95% confidence interval: -3.4 to -1.8). The decrease was statistically greater in cinnarizine (difference: -2.0; 95% confidence interval: -3.2 to -0.8) and sodium valproate (difference: -1.5; 95% confidence interval: -2.7 to -0.3) arms, compared to the placebo group. Seventy-one percent of individuals in the cinnarizine group, 66% of cases in the sodium valproate group, and 42% of people in the placebo arm reported more than 50% reduction in episodes at the end of the trial. The odds ratio for >50% responder rate was 3.5 (98.3% confidence interval: 1.3 to 9.3) for cinnarizine versus placebo and 2.7 (98.3% confidence interval: 1.0 to 6.9) for sodium valproate versus placebo. Nine individuals reported adverse effects (three in cinnarizine, five in sodium valproate, and one in the placebo group) and one case in the sodium valproate group discontinued the therapy due to severe sedation.
CONCLUSION
Cinnarizine and sodium valproate could be useful in migraine prophylaxis in children and adolescents. Trial registration: IRCT201206306907N4.",2020,The odds ratio for >50% responder rate was 3.5,"[""Children's Medical Center and Sina hospital, Tehran, Iran"", 'pediatric migraine', '158 children participated', 'children and adolescents', 'Eligible participants']","['cinnarizine and sodium valproate', 'Cinnarizine and sodium valproate', 'placebo', 'sodium valproate versus placebo', 'cinnarizine', 'sodium valproate', 'cinnarizine, sodium valproate, or placebo']","['efficacy of each drug in the prevention of migraine', 'frequency of migraine attacks', 'migraine frequency', 'mean change in frequency and intensity of migraine attacks', 'safety and efficacy', 'intensity of episodes', 'adverse effects']","[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0008803', 'cui_str': 'Cinnarizine'}, {'cui': 'C0037567', 'cui_str': 'Sodium Valproate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",158.0,0.759863,The odds ratio for >50% responder rate was 3.5,"[{'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Amanat', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mansoureh', 'Initials': 'M', 'LastName': 'Togha', 'Affiliation': 'Department of Neurology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Ramezani', 'Affiliation': 'Department of Neurology, Loghman Hakim Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Tavasoli', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Azizi Malamiri', 'Affiliation': 'Department of Paediatric Neurology, Golestan Medical, Educational, and Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Fashandaky', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Eshaghi', 'Affiliation': ""Department of Paediatric Infectious Disease, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahmoud Reza', 'Initials': 'MR', 'LastName': 'Ashrafi', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102419888485']
1401,31648910,"The immune response to a two-dose schedule of quadrivalent HPV vaccine in 9-13 year-old girls: Is it influenced by age, menarche status or body mass index?","HPV vaccines are highly immunogenic. A two-dose schedule for 9-14 year-old is recommended. However, no data exist regarding the impact of age, menarche status and body mass index (BMI) on the immune response to a two-dose schedule. In this post-hoc analysis, we present antibody titers to HPV6/11/16/18 in 9-13 year-old girls participating in a randomized clinical trial and assigned to receive two doses of quadrivalent HPV vaccine at 6 months interval (NCT00501137). Antibody titers were measured at month 7 and 24 of the study by using a competitive Luminex immunoassay (cLIA).Both, at Month 7 and 24 the GMTs for four HPV genotypes were similar across the age bands, and did not vary significantly by menarche status. Overweight and obese girls had lower GMTs. More than 99% of girls remained seropositive for HPV 6/11/16 and 89% for HPV18 at month 24. Comprehensive data in overweight and obese vaccines are warranted.",2019,More than 99% of girls remained seropositive for HPV 6/11/16 and 89% for HPV18 at month 24.,"['9-13\u202fyear-old girls', 'to HPV6/11/16/18 in 9-13\u202fyear-old girls participating', 'Overweight and obese girls had lower GMTs']","['HPV vaccines', 'quadrivalent HPV vaccine']","['antibody titers', 'Antibody titers']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",,0.0495155,More than 99% of girls remained seropositive for HPV 6/11/16 and 89% for HPV18 at month 24.,"[{'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Sauvageau', 'Affiliation': 'Quebec National Public Health Institute, Canada; Laval University, Canada; CHU de Québec Research Center, Canada. Electronic address: chantal.sauvageau@inspq.qc.ca.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Gilca', 'Affiliation': 'Quebec National Public Health Institute, Canada; Laval University, Canada; CHU de Québec Research Center, Canada.'}, {'ForeName': 'Robine', 'Initials': 'R', 'LastName': 'Donken', 'Affiliation': ""BC Children's Hospital Research Institute, Vaccine Evaluation Center, Canada; University of British Columbia School of Population and Public Health, Canada; Women's Health Research Institute, Canada.""}, {'ForeName': 'Shu Yu', 'Initials': 'SY', 'LastName': 'Fan', 'Affiliation': ""BC Children's Hospital Research Institute, Vaccine Evaluation Center, Canada.""}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Ogilvie', 'Affiliation': ""University of British Columbia School of Population and Public Health, Canada; Women's Health Research Institute, Canada.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dobson', 'Affiliation': ""BC Children's Hospital, Canada.""}]",Vaccine,['10.1016/j.vaccine.2019.09.089']
1402,31706541,Autologous Platelet-Rich Gel for the Treatment of Diabetic Sinus Tract Wounds: A Clinical Study.,"BACKGROUND
The aim of this study was to evaluate the efficacy of autologous platelet-rich gel (APG) in the treatment of deep sinus tract wounds from diabetic ulcers.
METHODS
Forty-eight patients with diabetic ulcers were randomly classified into two groups: an APG treatment group (25 patients) and a conventional wound dressing control group (23 patients). The sinus tract closure times, ulcer healing rates, hospitalization times, and hospitalization expenses of the two groups were compared.
RESULTS
There were no significant differences in the basic data and wound conditions between the two groups. The cure (healed wound) rates were 96% and 87% for the APG group and control group, respectively. During the first 4 wk, the sinus tract closure rate for the APG group was significantly higher than that for the control group. However, there was no significant difference in the sinus tract healing between the two groups at the end of the 8th wk. For the APG group and the control group, the average hospital stays were 19.36 ± 7.239 d and 48.13 ± 11.721 d, respectively, and the total hospitalization expenses were 2.48 ± 0.45 ten thousand yuan and 5.63 ± 1.35 ten thousand yuan (P < 0.05), respectively. These differences were statistically significant.
CONCLUSIONS
When compared with conventional wound dressings, APG can accelerate the healing of deep sinus tract wounds associated with diabetic ulcers.",2020,"The cure (healed wound) rates were 96% and 87% for the APG group and control group, respectively.","['deep sinus tract wounds from diabetic ulcers', 'Diabetic Sinus Tract Wounds', 'Forty-eight patients with diabetic ulcers']","['APG treatment', 'autologous platelet-rich gel (APG', 'conventional wound dressing control', 'Autologous Platelet-Rich Gel']","['basic data and wound conditions', 'average hospital stays', 'sinus tract closure rate', 'cure (healed wound) rates', 'sinus tract closure times, ulcer healing rates, hospitalization times, and hospitalization expenses', 'total hospitalization expenses', 'sinus tract healing']","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0743150', 'cui_str': 'Diabetic ulcer'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1265679', 'cui_str': 'Wound, healed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",48.0,0.0124028,"The cure (healed wound) rates were 96% and 87% for the APG group and control group, respectively.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China; Department of Plastic and Reconstructive Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China; Department of Plastic and Reconstructive Surgery, Anqing municipal hospital, Anqing, Anhui Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China. Electronic address: zhaoyuaps@163.com.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China.'}]",The Journal of surgical research,['10.1016/j.jss.2019.09.069']
1403,31707825,Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion.,"BACKGROUND
Recent court decisions have thrown into question the Food and Drug Administration's rules limiting manufacturer promotion of prescription drugs for unapproved uses. We assessed how providing pro forma disclosures or more descriptive evidence context about the data supporting an off-label claim affected physicians' beliefs about drug efficacy.
METHODS AND RESULTS
In online and mailed surveys, we randomized national samples of board-certified, clinically active cardiologists, internists, and endocrinologists to receive 1 of 3 information scenarios about a hypothetical drug derived verbatim from excerpts on the website for Vascepa, a prescription fish oil for which Food and Drug Administration specially permitted off-label promotion after a manufacturer lawsuit. The scenarios presented information about the approved on-label indication (severe hypertriglyceridemia), off-label claim + pro forma disclaimers (suggestive but not conclusive evidence for use as an add-on to a statin for patients reaching low-density lipoprotein goal but with persistent moderate hypertriglyceridemia), and off-label claim + evidence context (eg, reports on 3 trials failing to demonstrate cardiovascular benefit of other triglyceride-lowering drugs for such patients). Among 686 respondents (48% response rate), 29% reported receiving off-label information about Vascepa (ie, use as an add-on to a statin) from the manufacturer, and 16% had prescribed it off-label for this purpose. Off-label prescribing was 5 times higher among physicians who received such off-label information (38% versus 7%, P <0.001). For the hypothetical drug, the proportion of physicians endorsing the unproven claim that the drug reduced cardiovascular risk was similar among those randomized to the on-label and off-label claim + pro forma disclaimers scenarios (35% versus 37% [95% CI, -6% to 11%]), but substantially lower among those randomized to the off-label claim + evidence context scenario (21% [95% CI, -24% to 7%]).
CONCLUSIONS
Physicians who received company information about the unapproved use of Vascepa were more likely to report prescribing it off-label. Supplementing off-label claims with evidence context improved the prescribers' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.",2019,"Supplementing off-label claims with evidence context improved the prescribers' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.","['686 respondents (48% response rate), 29% reported receiving off-label information about Vascepa (ie, use as an add-on to a statin) from the manufacturer, and 16% had prescribed it off-label for this purpose']",[],['cardiovascular risk'],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3486026', 'cui_str': 'Vascepa'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]",[],"[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",686.0,0.137453,"Supplementing off-label claims with evidence context improved the prescribers' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Schwartz', 'Affiliation': 'Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH (L.M.S., S.W.).'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Woloshin', 'Affiliation': 'Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH (L.M.S., S.W.).'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School in Boston, MA (Z.L., F.A.T., A.S.K.).""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'American Board of Internal Medicine, Philadelphia, PA (K.M.R.).'}, {'ForeName': 'Frazer A', 'Initials': 'FA', 'LastName': 'Tessema', 'Affiliation': ""Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School in Boston, MA (Z.L., F.A.T., A.S.K.).""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Peter', 'Affiliation': 'The Center for Outcomes Research & Evaluation (CORE), Yale-New Haven Hospital, New Haven, CT (D.P.).'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Kesselheim', 'Affiliation': ""Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School in Boston, MA (Z.L., F.A.T., A.S.K.).""}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006073']
1404,31707826,Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial.,"BACKGROUND
In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), alirocumab was compared with placebo, added to high-intensity or maximum tolerated statin treatment after acute coronary syndrome in 18 924 patients. Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths. The present analysis determined whether alirocumab reduced total (first and subsequent) hospitalizations and death and increased days alive and out of hospital (DAOH) and percent DAOH in ODYSSEY OUTCOMES.
METHODS AND RESULTS
In prespecified analyses, hazard functions for total hospitalizations and death were jointly estimated by a semiparametric model, while in post hoc analyses, DAOH and percent DAOH were compared between treatment groups with Poisson regression and one-inflated beta regression, respectively. With 16 629 total hospitalizations and 726 deaths, 331 fewer hospitalizations, and 58 fewer deaths were observed with alirocumab compared with placebo, translating to 15.6 total hospitalizations or deaths avoided with alirocumab per 1000 patient-years of assigned treatment. Alirocumab reduced total hospitalizations (hazard ratio, 0.96 [95% CI, 0.92-1.00]; P =0.04) and increased DAOH relative to placebo (rate ratio, 1.003 [95% CI, 1.000-1.007]; P =0.05), primarily through a reduction in days dead (rate ratio, 0.847 [95% CI, 0.728-0.986]; P =0.03). Patients randomized to alirocumab were also more likely to survive to the end of the study without hospitalization (odds ratio, 1.06 [95% CI, 1.00-1.13]; P =0.03).
CONCLUSIONS
Alirocumab reduced total hospitalizations with corresponding small increases in DAOH and percent DAOH. These outcomes provide alternative patient-centered metrics to capture the totality of alirocumab clinical efficacy after acute coronary syndrome.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01663402.",2019,"Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths.",[],"['placebo', 'Alirocumab', 'alirocumab']","['Total Hospitalizations and Increases Days Alive and Out of Hospital', 'hazard functions for total hospitalizations and death', 'coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths', 'alirocumab reduced total (first and subsequent) hospitalizations and death and increased days alive and out of hospital (DAOH) and percent DAOH', 'total hospitalizations', 'DAOH relative']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",331.0,0.262428,"Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, NY (M.S.).'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris and Paris University, Sorbonne Paris Cité, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France (P.G.S.).'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'DiCenso', 'Affiliation': 'Woodhull Medical Center, Brooklyn, NY (D.D.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL (V.A.B.).'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Budaj', 'Affiliation': 'Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada and St Michael's Hospital, University of Toronto, Ontario, Canada (S.G.G.).""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gotcheva', 'Affiliation': 'MHAT ""National Cardiology Hospital"" EAD, Sofia, Bulgaria (N.G.).'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, the Netherlands (J.W.J.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (R.P.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R.).'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Sourdille', 'Affiliation': 'Sanofi, Bridgewater, NJ (T.S.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand (H.D.W.).'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College, Bangalore, India (D.X.).""}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany (A.M.Z.).'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO (G.G.S.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005858']
1405,30843450,"Vortioxetine for attention deficit hyperactivity disorder in adults: A randomized, double-blind, placebo-controlled, proof-of-concept study.","BACKGROUND
Stimulants remain the mainstay of treatment for attention-deficit hyperactivity disorder (ADHD) but are often associated with insufficient response or poor tolerability, leading to many patients not wishing to be treated with controlled substances.
AIMS
This randomized, placebo-controlled, proof-of-concept study (NCT02327013) evaluated the efficacy of a multimodal antidepressant, vortioxetine, in the treatment of ADHD, using a two-stage sequential parallel comparison design.
METHODS
Patients aged 18-55 years with a diagnosis of ADHD (DSM-5) and a total score ⩾24 on the Adult ADHD Investigator Symptom Rating Scale (AISRS) were randomized in study stage I with a 1:1:3 ratio to six weeks of treatment with vortioxetine 10 or 20 mg/day, or placebo ( n = 227). In study stage II, placebo non-responders (AISRS total score reduction <30% from stage I baseline) were re-randomized with a 1:1:1 ratio to six weeks of vortioxetine 10 or 20 mg/day, or placebo ( n = 59).
RESULTS
Across the two study stages combined, ADHD symptoms improved by approximately eight AISRS points in all treatment groups, showing no difference from placebo for either dose of vortioxetine, the study thus failing to meet its primary endpoint. However, both doses of vortioxetine separated from placebo in improving overall patient functioning, as measured by the Sheehan Disability Scale.
CONCLUSION
Studies are warranted to further investigate this suggested benefit of a multimodal antidepressant for patient functioning in ADHD while addressing issues of non-adherence and placebo response. The study confirmed vortioxetine 10 mg and 20 mg as generally well-tolerated.",2019,"Across the two study stages combined, ADHD symptoms improved by approximately eight AISRS points in all treatment groups, showing no difference from placebo for either dose of vortioxetine, the study thus failing to meet its primary endpoint.","['attention deficit hyperactivity disorder in adults', '\n\n\nPatients aged 18-55 years with a diagnosis of ADHD (DSM-5) and a total score ⩾24 on the Adult ADHD Investigator Symptom Rating Scale (AISRS) were randomized in study stage']","['vortioxetine', 'Vortioxetine', 'multimodal antidepressant, vortioxetine', 'placebo']","['ADHD symptoms', 'Sheehan Disability Scale', 'overall patient functioning']","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings (staging scale)'}, {'cui': 'C0222045'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",227.0,0.539755,"Across the two study stages combined, ADHD symptoms improved by approximately eight AISRS points in all treatment groups, showing no difference from placebo for either dose of vortioxetine, the study thus failing to meet its primary endpoint.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': '1 Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Lindsten', 'Affiliation': '2 H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Lasse B', 'Initials': 'LB', 'LastName': 'Sluth', 'Affiliation': '2 H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Maria Louise', 'Initials': 'ML', 'LastName': 'Petersen', 'Affiliation': '2 H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ettrup', 'Affiliation': '2 H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Hanne-Lise F', 'Initials': 'HF', 'LastName': 'Eriksen', 'Affiliation': '2 H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': '1 Massachusetts General Hospital, Boston, MA, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119832538']
1406,27888737,An intervention to improve sibling relationship quality among youth in foster care: Results of a randomized clinical trial.,"Sibling programming is an important part of a prevention framework, particularly for youth in foster care. After children are removed from their families and placed into foster care in the aftermath of maltreatment, the sibling relationship is often the most viable ongoing relationship available to the child, and may be critical to a youth's sense of connection, emotional support, and continuity. The promise of dyadic sibling programming in particular rests on the ability of interventions to enhance the quality of sibling relationships; yet little research exists that suggests that sibling interventions can improve relationship quality among foster youth. The primary aim of the current study was to examine the effects of a specific dyadic sibling-focused intervention for older and younger siblings on sibling relationship quality. One hundred sixty four dyads (328 youth) participated in the study, with each dyad consisting of an older sibling between 11 and 15 years of age at baseline and a younger sibling separated in age by less than 4 years. Hierarchical linear models were applied to self-reported, observer-reported and observational data over the 18-month study period. Findings suggest that the sibling intervention holds promise for improving sibling relationship quality among youth in foster care. Implications and future directions for research are discussed.",2017,The promise of dyadic sibling programming in particular rests on the ability of interventions to enhance the quality of sibling relationships; yet little research exists that suggests that sibling interventions can improve relationship quality among foster youth.,"['older and younger siblings on sibling relationship quality', 'One hundred sixty four dyads (328 youth) participated in the study, with each dyad consisting of an older sibling between 11 and 15 years of age at baseline and a younger sibling separated in age by less than 4 years', 'youth in foster care']",['specific dyadic sibling-focused intervention'],['sibling relationship quality'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0239519,The promise of dyadic sibling programming in particular rests on the ability of interventions to enhance the quality of sibling relationships; yet little research exists that suggests that sibling interventions can improve relationship quality among foster youth.,"[{'ForeName': 'Brianne H', 'Initials': 'BH', 'LastName': 'Kothari', 'Affiliation': 'Oregon State University, Cascades, United States. Electronic address: Brianne.kothari@osucascades.edu.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'McBeath', 'Affiliation': 'Portland State University, United States; Oregon Social Learning Center, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sorenson', 'Affiliation': 'Portland State University, United States.'}, {'ForeName': 'Lew', 'Initials': 'L', 'LastName': 'Bank', 'Affiliation': 'Portland State University, United States; Oregon Social Learning Center, United States.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Waid', 'Affiliation': 'University of Minnesota, Twin Cities, United States.'}, {'ForeName': 'Sara Jade', 'Initials': 'SJ', 'LastName': 'Webb', 'Affiliation': 'Portland State University, United States.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Steele', 'Affiliation': 'Portland State University, United States.'}]",Child abuse & neglect,['10.1016/j.chiabu.2016.11.010']
1407,30852939,Antibody and B cell responses to an investigational adjuvanted RSV vaccine for older adults.,"Background : Infections with respiratory syncytial virus (RSV) cause significant morbidity and hospitalization in older adults. We studied the humoral, mucosal and B cell responses of an investigational adjuvanted RSV sF vaccine, MEDI7510, in older adults. Methods : In a substudy of a randomized (1:1), double-blind, placebo-controlled study of MEDI7510 in adults ≥60 years of age, we collected blood and nasal secretions at days 0, 8, 29, 91 and 180 post-vaccination to measure F-specific IgG and IgA antibodies by ELISA, and plasmablasts and memory B cells by IgA/IgG dual-color fluorospot. Results : The 27 vaccine- and 18 placebo-recipients had a mean age of 73 years and included 24 women. Among vaccinees, 93% had significant increases in F-specific plasma IgG 85% had increased plasma IgA; 74% had increased nasal IgG and 26% nasal IgA; 93% had IgG and 89% IgA plasmablasts on Day 8 post-immunization; and 82% had IgG and 7.4% IgA memory B cell responses to the vaccine. Vaccinees <70 years of age and women had the highest responses to the vaccine. Conclusions : This adjuvanted vaccine generated robust humoral immune responses in older adults, including RSV F-specific systemic and mucosal antibodies and memory B cells. Nevertheless, age ≥70 years was associated with decreased immunogenicity of the adjuvanted vaccine.",2019,"This adjuvanted vaccine generated robust humoral immune responses in older adults, including RSV F-specific systemic and mucosal antibodies and memory B cells.","['adults ≥60\xa0years of age, we collected blood and nasal secretions at days 0, 8, 29, 91 and 180 post-vaccination to measure F-specific IgG and IgA antibodies by ELISA, and plasmablasts and memory B cells by IgA/IgG dual-color fluorospot', 'recipients had a mean age of 73\xa0years and included 24 women', 'older adults']","['MEDI7510', 'investigational adjuvanted RSV vaccine', 'respiratory syncytial virus (RSV', 'placebo']","['humoral immune responses', 'F-specific plasma IgG']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005768'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1155229'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",24.0,0.321515,"This adjuvanted vaccine generated robust humoral immune responses in older adults, including RSV F-specific systemic and mucosal antibodies and memory B cells.","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weinberg', 'Affiliation': 'Departments of Pediatrics, University of Colorado Denver School of Medicine, Anschutz Medical Center , Aurora, CO , USA.'}, {'ForeName': 'Stacie L', 'Initials': 'SL', 'LastName': 'Lambert', 'Affiliation': 'Translational Sciences, MedImmune , Mountain View , CA , USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Canniff', 'Affiliation': 'Departments of Pediatrics, University of Colorado Denver School of Medicine, Anschutz Medical Center , Aurora, CO , USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Statistical Sciences, MedImmune , Gaithersburg , MD , USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lang', 'Affiliation': 'Departments of Pediatrics, University of Colorado Denver School of Medicine, Anschutz Medical Center , Aurora, CO , USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Esser', 'Affiliation': 'Translational Medicine, MedImmune , Gaithersburg , MD , USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Falloon', 'Affiliation': 'Clinical Development, MedImmune , Gaithersburg , MD , USA.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Departments of Pediatrics, University of Colorado Denver School of Medicine, Anschutz Medical Center , Aurora, CO , USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1589282']
1408,30900194,Effects of Dog Assisted Therapy for Adults with Autism Spectrum Disorder: An Exploratory Randomized Controlled Trial.,"Effective treatments of highly prevalent stress-related outcomes such as depression and anxiety are understudied in adults with autism spectrum disorder (ASD). A randomized controlled trial with baseline, post-intervention, and 10-week follow-up, that explores the effects of animal assisted therapy (AAT) was conducted. In total, 53 adults with ASD with normal to high intelligence were randomized in an intervention (N = 27) versus waiting list control group (N = 26). The remarkable adherence to the therapy program by study participants and the program's clinically relevant effects indicate that AAT with dogs can be used to reduce perceived stress and symptoms of agoraphobia, and to improve social awareness and communication in adults with ASD with normal to high intelligence.",2020,"The remarkable adherence to the therapy program by study participants and the program's clinically relevant effects indicate that AAT with dogs can be used to reduce perceived stress and symptoms of agoraphobia, and to improve social awareness and communication in adults with ASD with normal to high intelligence.","['Spectrum Disorder', '53 adults with ASD with normal to high intelligence', 'Adults with Autism', 'adults with autism spectrum disorder (ASD', 'adults with ASD with normal to high intelligence']","['waiting list control', 'animal assisted therapy (AAT', 'Dog Assisted Therapy']",[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150133', 'cui_str': 'Animal Facilitated Therapy'}, {'cui': 'C0012984', 'cui_str': 'Canis familiaris'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],53.0,0.0770418,"The remarkable adherence to the therapy program by study participants and the program's clinically relevant effects indicate that AAT with dogs can be used to reduce perceived stress and symptoms of agoraphobia, and to improve social awareness and communication in adults with ASD with normal to high intelligence.","[{'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Wijker', 'Affiliation': 'GGZ Oost Brabant, P.O. Box 3, 5427 ZG, Boekel, The Netherlands. carolien.wijker@ou.nl.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Leontjevas', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Open University of the Netherlands, Heerlen, The Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Spek', 'Affiliation': 'Autism Center of Expertise, Eemnes, The Netherlands.'}, {'ForeName': 'Marie-Jose', 'Initials': 'MJ', 'LastName': 'Enders-Slegers', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Open University of the Netherlands, Heerlen, The Netherlands.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03971-9']
1409,31888419,Taking another's perspective promotes right parieto-frontal activity that reflects open-minded thought.,"Critical thinking (CT) is important for consensus building. Although the practice of CT using debate is widely used to improve open-minded thought, the cognitive processes underlying this improvement remain poorly understood. Here, functional magnetic resonance imaging (fMRI) was employed to assess how neural responses while considering another's opinion are changed by CT practice and to determine whether the cortical network showing activation changes related to personality traits is relevant to consensus building. A total of 52 healthy participants were divided into three groups for an intervention; the participants read another's reasoning regarding a controversial issue and judged whether this person's viewpoint was affirmative during fMRI measurements. The intervention required them to prepare speech texts from a designated viewpoint based on both themselves and others. Compared to the control group, the group who took another's perspective showed enhanced activation of the right parieto-frontal network, that has been implicated in belief update, cognitive reappraisal of emotion, and self-perspective inhibition. Additionally, activation of the orbitofrontal cortex was negatively correlated with a stubbornness index. The results provide the first neural evidence of the effects of CT practice and support the notion that open-minded thought underlies the benefits of this practice.",2020,"Compared to the control group, the group who took another's perspective showed enhanced activation of the right parieto-frontal network, that has been implicated in belief update, cognitive reappraisal of emotion, and self-perspective inhibition.",['52 healthy participants'],"['Critical thinking (CT', 'functional magnetic resonance imaging (fMRI']",['activation of the orbitofrontal cortex'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C2331062', 'cui_str': 'Orbital Area'}]",52.0,0.0191253,"Compared to the control group, the group who took another's perspective showed enhanced activation of the right parieto-frontal network, that has been implicated in belief update, cognitive reappraisal of emotion, and self-perspective inhibition.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Miura', 'Affiliation': 'Faculty of Engineering, Tohoku Institute of Technology , Sendai, Miyagi, Japan.'}, {'ForeName': 'Motoaki', 'Initials': 'M', 'LastName': 'Sugiura', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Nozawa', 'Affiliation': 'Research Center for the Earth Inclusive Sensing Empathizing with Silent Voices, Tokyo Institute of Technology , Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Sasaki', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Yamazaki', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Kanan', 'Initials': 'K', 'LastName': 'Hirano', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Graduate School of Engineering, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}]",Social neuroscience,['10.1080/17470919.2019.1710249']
1410,31338732,Nicotinic treatment of post-chemotherapy subjective cognitive impairment: a pilot study.,"PURPOSE
Persistent chemotherapy-related cognitive impairment (pCRCI) is commonly reported following cancer treatment and negatively affects quality of life; however, there is currently no pharmacological treatment indicated for pCRCI. This pilot study obtained preliminary data regarding the use of transdermal nicotine patches as a therapeutic strategy for women with pCRCI to (1) reduce subjective cognitive complaints and (2) enhance objective cognitive performance in breast, colon, lymphoma, or ovarian cancer survivors with pCRCI.
METHODS
Participants were randomized to either placebo (n = 11) or transdermal nicotine (n = 11) for 6 weeks, followed by 2 weeks of treatment withdrawal for a total of 8 weeks. Participants were assessed using both subjective and objective measures of cognitive functioning at five visits before, during, and after treatment.
RESULTS
Over the course of the study, women in both groups improved substantially in severity of self-reported cognitive complaints measured by Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairments regardless of treatment arm. Additionally, objective cognitive performance measures improved in both groups; however, there was no significant difference in improvement between groups.
CONCLUSIONS
Due to a large placebo response, we were unable to determine if a drug effect was present. However, we did observe substantial improvement in self-reported cognitive symptoms, likely resulting from factors related to participation in the trial rather than specific drug treatment effects.
TRIAL REGISTRATION
The study was registered with clinicaltrials.gov (trial registration: NCT02312943).
IMPLICATIONS FOR CANCER SURVIVORS
These results suggest that women with pCRCI can exhibit improvement in subjective cognition, with attention paid to symptoms and close follow-up over a short period of time.",2019,", women in both groups improved substantially in severity of self-reported cognitive complaints measured by Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairments regardless of treatment arm.","['Participants', 'FOR CANCER SURVIVORS', 'women with pCRCI to (1) reduce subjective cognitive complaints and (2) enhance objective cognitive performance in breast, colon, lymphoma, or ovarian cancer survivors with pCRCI', 'post-chemotherapy subjective cognitive impairment']","['Nicotinic', 'placebo', 'transdermal nicotine', 'transdermal nicotine patches']","['severity of self-reported cognitive complaints', 'subjective cognition', 'objective cognitive performance measures']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439577', 'cui_str': 'Post-chemotherapy (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.228972,", women in both groups improved substantially in severity of self-reported cognitive complaints measured by Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairments regardless of treatment arm.","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Vega', 'Affiliation': 'Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA. Jennifer.n.vega.1@vumc.org.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Albert', 'Affiliation': 'Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center/Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.'}, {'ForeName': 'Warren D', 'Initials': 'WD', 'LastName': 'Taylor', 'Affiliation': 'Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Newhouse', 'Affiliation': 'Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00786-6']
1411,31347010,Psychological intervention (ConquerFear) for treating fear of cancer recurrence: mediators and moderators of treatment efficacy.,"PURPOSE
ConquerFear is an efficacious intervention for fear of cancer recurrence (FCR) that demonstrated greater improvements than an attention control (relaxation training) in a randomized controlled trial. This study aimed to determine mediators and moderators of the relative treatment efficacy of ConquerFear versus relaxation.
METHODS
One hundred and fifty-two cancer survivors completed 5 therapy sessions and outcome measures before and after intervention and at 6 months' follow-up. We examined theoretically relevant variables as potential mediators and moderators of treatment outcome. We hypothesized that metacognitions and intrusions would moderate and mediate the relationship between treatment group and FCR level at follow-up.
RESULTS
Only total FCR score at baseline moderated treatment outcome. Participants with higher levels of FCR benefited more from ConquerFear relative to relaxation on the primary outcome. Changes in metacognitions and intrusive thoughts about cancer during treatment partially mediated the relationship between treatment group and FCR.
CONCLUSIONS
These results show that ConquerFear is relatively more effective than relaxation for those with overall higher levels of FCR. The mediation analyses confirmed that the most likely mechanism of treatment efficacy was the reduction in unhelpful metacognitions and intrusive thoughts during treatment, consistent with the theoretical framework underpinning ConquerFear.
IMPLICATIONS FOR CANCER SURVIVORS
ConquerFear is a brief, effective treatment for FCR in cancer survivors with early-stage disease. The treatment works by reducing intrusive thoughts about cancer and changing beliefs about worry and is particularly helpful for people with moderate to severe FCR.",2019,"Changes in metacognitions and intrusive thoughts about cancer during treatment partially mediated the relationship between treatment group and FCR.
","['One hundred and fifty-two cancer survivors', 'cancer survivors with early-stage disease', 'people with moderate to severe FCR']","['attention control (relaxation training', 'ConquerFear versus relaxation', 'Psychological intervention (ConquerFear']",['total FCR score'],"[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0577072,"Changes in metacognitions and intrusive thoughts about cancer during treatment partially mediated the relationship between treatment group and FCR.
","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Sharpe', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia. louise.sharpe@sydney.edu.au.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Mental Health Centre, Faculty of Medicine, University of Queensland, Saint Lucia, Australia.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Fardell', 'Affiliation': ""Kids Cancer Centre, Sydney Children's Hospital and School of Women's and Children's Health, Faculty of Medicine, University of New South Wales, Saint Lucia, Australia.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thewes', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Smith', 'Affiliation': 'Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gilchrist', 'Affiliation': 'Crown Princess Mary Cancer Centre, Breast Cancer Institute, Westmead Hospital, Westmead, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beith', 'Affiliation': 'Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Camperdown, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Girgis', 'Affiliation': 'Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tesson', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Day', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Grunewald', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Butow', 'Affiliation': 'School of Psychology, University of Sydney, Brennan MacCallum (A18), Camperdown, NSW, 2006, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00788-4']
1412,30834932,A cluster randomised controlled feasibility study of nurse-initiated behavioural strategies to manage interruptions during medication administration.,"OBJECTIVES
To examine the feasibility of a behavioural e-learning intervention to support nurses to manage interruptions during medication administration.
DESIGN
A cluster randomised feasibility trial.
SETTING
The cluster trial included four intervention and four control wards randomly selected across four metropolitan hospitals in Sydney, Australia.
PARTICIPANTS
We observed 806 (402 pre-intervention and 404 post-intervention) medication events, where nurses prepared and administered medications to patients within the cluster wards.
MAIN OUTCOME MEASURES
The primary outcome measured was the observed number of interruptions occurring during administration, with secondary outcomes being the number of clinical errors and procedural failures. Changes in the use of behavioural strategies to manage interruptions, targeted by the e-learning intervention, were also assessed.
RESULTS
No significant differences were found in the number of interruptions (P = 0.82), procedural failures (P = 0.19) or clinical errors per 100 medications (P = 0.32), between the intervention and control wards. Differences in the use of specific behavioural strategies (engagement and multitasking) were found in the intervention wards.
CONCLUSION
This behavioural e-learning intervention has not been found to significantly reduce interruptions, however, changes in the use of strategies did occur. Careful selection of clinical settings where there is a high number of predictable interruptions is recommended for further research into the impact of the behavioural e-learning intervention. An increase in the intensity of this intervention is recommended with training undertaken away from the clinical setting. Further research on additional consumer-sensitive interventions is urgently needed.",2019,"No significant differences were found in the number of interruptions (P = 0.82), procedural failures (P = 0.19) or clinical errors per 100 medications (P = 0.32), between the intervention and control wards.","['The cluster trial included four intervention and four control wards randomly selected across four metropolitan hospitals in Sydney, Australia']","['behavioural e-learning intervention', 'nurse-initiated behavioural strategies']","['observed number of interruptions occurring during administration, with secondary outcomes being the number of clinical errors and procedural failures', 'procedural failures', 'number of interruptions']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.047115,"No significant differences were found in the number of interruptions (P = 0.82), procedural failures (P = 0.19) or clinical errors per 100 medications (P = 0.32), between the intervention and control wards.","[{'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Office of the Executive Dean, Faculty of Health Sciences, Australian Catholic University, PO Box 968, North Sydney, NSW, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Langdon', 'Affiliation': 'Centre for Applied Nursing Research (CANR), Ingham Institute for Applied Medical Research, Western Sydney University, Locked Bag 7103, Liverpool BC, NSW 1871, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Levett-Jones', 'Affiliation': 'Nursing Education, University of Technology, 235 Jones St, Ultimo, NSW, Sydney, Australia.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Weidemann', 'Affiliation': 'School of Social Sciences and Psychology, Western Sydney University, Locked Bag, Penrith, NSW 2751, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Manias', 'Affiliation': 'Faculty of Health, School of Nursing and Midwifery, Deakin University, Centre for Quality and Patient Safety Research.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Everett', 'Affiliation': 'Western Sydney University, School of Nursing and Midwifery, Centre for Applied Nursing Research, Ingham Institute for Applied Medical Research.'}]",International journal for quality in health care : journal of the International Society for Quality in Health Care,['10.1093/intqhc/mzz007']
1413,30779861,Cost-Effectiveness of Osteoporosis Interventions to Improve Quality of Care After Upper Extremity Fracture: Results From a Randomized Trial (C-STOP Trial).,"We assessed the cost-effectiveness of two models of osteoporosis care after upper extremity fragility fracture using a high-intensity Fracture Liaison Service (FLS) Case-Manager intervention versus a low-intensity FLS (ie, Active Control), and both relative to usual care. This analysis used data from a pragmatic patient-level parallel-arm comparative effectiveness trial of 361 community-dwelling participants 50 years or older with upper extremity fractures undertaken at a Canadian academic hospital. We used a decision-analytic Markov model to evaluate the cost-effectiveness of the three treatment alternatives. The perspective was health service payer; the analytical horizon was lifetime; costs and health outcomes were discounted by 3%. Costs were expressed in 2016 Canadian dollars (CAD) and the health effect was measured by quality adjusted life years (QALYs). The average age of enrolled patients was 63 years and 89% were female. Per patient cost of the Case Manager and Active Control interventions were $66CAD and $18CAD, respectively. Compared to the Active Control, the Case Manager saved $333,000, gained seven QALYs, and averted nine additional fractures per 1000 patients. Compared to usual care, the Case Manager saved $564,000, gained 14 QALYs, and incurred 18 fewer fractures per 1000 patients, whereas the Active Control saved $231,000, gained seven QALYs, and incurred nine fewer fractures per 1000 patients. Although both interventions dominated usual care, the Case Manager intervention also dominated the Active Control. In 5000 probabilistic simulations, the probability that the Case Manager intervention was cost-effective was greater than 75% whereas the Active Control intervention was cost-effective in less than 20% of simulations. In summary, although the adoption of either of these approaches into clinical settings should lead to cost savings, reduced fractures, and increased quality-adjusted life for older adults following upper extremity fracture, the Case Manager intervention would be the most likely to be cost-effective. © 2019 American Society for Bone and Mineral Research.",2019,"Compared to usual care, the Case Manager saved $564,000, gained 14 QALYs, and incurred 18 fewer fractures per 1000 patients, whereas the Active Control saved $231,000, gained seven QALYs, and incurred nine fewer fractures per 1000 patients.","['older adults following upper extremity fracture', '© 2019 American Society for Bone and Mineral Research', 'average age of enrolled patients was 63 years and 89% were female', '361 community-dwelling participants 50 years or older with upper extremity fractures undertaken at a Canadian academic hospital', 'After Upper Extremity Fracture']","['high-intensity Fracture Liaison Service (FLS) Case-Manager intervention versus a low-intensity FLS (ie, Active Control', 'Osteoporosis Interventions']","['Quality of Care', 'cost-effective', 'cost-effectiveness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",361.0,0.0240633,"Compared to usual care, the Case Manager saved $564,000, gained 14 QALYs, and incurred 18 fewer fractures per 1000 patients, whereas the Active Control saved $231,000, gained seven QALYs, and incurred nine fewer fractures per 1000 patients.","[{'ForeName': 'Sumit R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Lier', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Finlay A', 'Initials': 'FA', 'LastName': 'McAlister', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Rowe', 'Affiliation': 'Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beaupre', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, AB, Canada.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3699']
1414,30856542,Cost-Effectiveness of a Technology-Enhanced Diabetes Care Management Program in Mexico.,"BACKGROUND
The prevalence of diabetes has increased substantially in Mexico over the last 40 years, leading to significant impacts on population health and the healthcare system. Technology-based solutions may improve diabetes outcomes in areas where lack of efficient transportation creates barriers to care.
OBJECTIVES
To estimate the lifetime cost-effectiveness of a technology-based diabetes care management program from the perspective of the Mexican healthcare system.
METHODS
Clinical outcomes and cost data from a 3-arm randomized clinical trial of Dulce Wireless Tijuana, a diabetes care management program incorporating short-term mobile technology, were used as inputs in a validated simulation model for type 2 diabetes. Study arms included a control group (CG), Project Dulce diabetes care management (PD), and Project Dulce with technology enhancement (PD-TE).
RESULTS
Intervention costs were $1448 for PD and $1740 for PD-TE compared with $740 for CG. Both intervention arms increased quality-adjusted life-years and costs. The incremental cost-effectiveness ratio for PD was $1635 and for PD-TE was $2220, both compared with CG. The incremental cost-effectiveness ratio for PD-TE versus PD was $4299. The results were sensitive to the time horizon. The PE and PD-TE interventions were cost-effective under time horizons of 15 to 20 years, but were not cost-effective under time horizons of 5 to 10 years.
CONCLUSIONS
Both the PD and PD-TE were highly cost-effective from a Mexican health system perspective. Considering the economic impact of the diabetes epidemic and the widespread use of cellular technology in Mexico, implementation of PD-TE is warranted.",2019,"The incremental cost-effectiveness ratio for PD was $1635 and for PD-TE was $2220, both compared with CG.",['Mexico'],"['technology-based diabetes care management program', 'Technology-Enhanced Diabetes Care Management Program', 'Dulce Wireless Tijuana, a diabetes care management program incorporating short-term mobile technology', 'control group (CG), Project Dulce diabetes care management (PD), and Project Dulce with technology enhancement (PD-TE']","['incremental cost-effectiveness ratio for PD', 'Cost Effectiveness', 'incremental cost-effectiveness ratio', 'quality-adjusted life-years and costs']","[{'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0165112,"The incremental cost-effectiveness ratio for PD was $1635 and for PD-TE was $2220, both compared with CG.","[{'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Gilmer', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA. Electronic address: tgilmer@ucsd.edu.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Burgos', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Maria Cecilia', 'Initials': 'MC', 'LastName': 'Anzaldo-Campos', 'Affiliation': 'Hospital General Regional No. 20 Instituto Mexicano del Seguro Social, Tijuana, Baja California, Mexico.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Vargas-Ojeda', 'Affiliation': 'Autonomous University of Baja California, Tijuana, Baja California, Mexico.'}]",Value in health regional issues,['10.1016/j.vhri.2018.12.006']
1415,30849287,Comparing the effectiveness of individual and group therapy for students with symptoms of anxiety and depression: A randomized pilot study.,"Objective: To examine the effectiveness of individual versus group therapy for anxiety and depression among university students. Participants: Forty-one university students experiencing moderate to severe symptoms of anxiety and/or depression participated during one of three academic semesters from 2015 to 2016. Methods: Participants were randomly assigned to either 6-weeks of individual or group therapy and completed outcome measures at pre-and-post-treatment. Results: Significant reductions in both depression and anxiety scores were found across time, with no significant difference between group and individual therapy outcomes. Exploratory analysis of attitudes toward therapy found that while individual therapy was rated more favorably than group therapy overall, attitudes toward therapy became more favorable from pre to post-treatment for all participants. An interaction showed differences in attitudes toward individual and group therapy according to participants' randomly assigned treatment. Conclusions: These findings support the increased usage of group therapy within university counseling centers, with implications for stepped care discussed.",2020,"RESULTS
Significant reductions in both depression and anxiety scores were found across time, with no significant difference between group and individual therapy outcomes.","['anxiety and depression among university students', 'students with symptoms of anxiety and depression', 'Forty-one university students experiencing moderate to severe symptoms of anxiety and/or depression participated during one of three academic semesters from 2015 to 2016', 'Participants']","['6-weeks of individual or group therapy and completed outcome measures at pre-and-post-treatment', 'individual and group therapy']",['depression and anxiety scores'],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0309236,"RESULTS
Significant reductions in both depression and anxiety scores were found across time, with no significant difference between group and individual therapy outcomes.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fawcett', 'Affiliation': ""Student Wellness and Counselling Centre, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Neary', 'Affiliation': ""HOPE Program, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ginsburg', 'Affiliation': ""Eastern Health, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cornish', 'Affiliation': ""Student Wellness and Counselling Centre, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.""}]",Journal of American college health : J of ACH,['10.1080/07448481.2019.1577862']
1416,30768413,"Changing Conceptions of Death as a Function of Depression Status, Suicidal Ideation, and Media Exposure in Early Childhood.","OBJECTIVE
This study characterized 3- to 6-year-old children's understanding of death as a function of depression status, suicidal ideation (SI), and media consumption.
METHOD
Participants were 79 children with depression (3.0-6.11 years old) who completed a comprehensive psychiatric assessment and experimenter-led death interview and a comparison group of 60 healthy children (4.0-7.12 years old). The interview assessed children's understanding of 5 concepts of death: universality, applicability, irreversibility, cessation, and causality. Children's mastery of each concept and overall understanding of death was examined as a function of depression and SI status: depressed with SI (n = 22), depressed without SI (n = 57), and healthy (n = 60). Children's observed emotional reactions to hearing about natural death, accidental death, and suicide were assessed by death-themed stories. Parent reports of children's television and videogames/internet consumption assessed links between media exposure and understanding of death.
RESULTS
Children with depression and SI scored higher on overall understanding of death than those with depression without SI and healthy children. They also exhibited more sad and anxious affect listening to death-themed stories and were more likely to describe death as caused by violence. Across this sample, older children also were more likely to depict death as violent. More television use was associated with less understanding of death, including the concept of irreversibility.
CONCLUSION
Children with depression and SI have a more advanced understanding of death than their peers, dispelling the myth that these ideations arise in the context of a poor understanding of death. The increase in violence attributions across early childhood could indicate increasing normalization of violence in children's perceptions of death.
CLINICAL TRIAL REGISTRATION INFORMATION
A Randomized Controlled Trial of PCIT-ED for Preschool Depression; http://clinicaltrials.gov; NCT00595283.",2019,"Children's mastery of each concept and overall understanding of death was examined as a function of depression and SI status: depressed with SI (n = 22), depressed without SI (n = 57), and healthy (n = 60).",['Participants were 79 children with depression (3.0-6.11 years old) who completed a comprehensive psychiatric assessment and experimenter-led death interview and a comparison group of 60 healthy children (4.0-7.12 years old'],[],"['violence attributions', 'overall understanding of death', 'emotional reactions to hearing about natural death, accidental death, and suicide']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}]",[],"[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0277610', 'cui_str': 'Natural death (event)'}, {'cui': 'C0277638', 'cui_str': 'Accidental death (event)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",79.0,0.0507784,"Children's mastery of each concept and overall understanding of death was examined as a function of depression and SI status: depressed with SI (n = 22), depressed without SI (n = 57), and healthy (n = 60).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hennefield', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO. Electronic address: lhennefield@wustl.edu.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Whalen', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Wood', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Chavarria', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.07.909']
1417,30675096,Drainage During Endoscopic Thyroidectomy.,"Background
Conventional cervical drainage tubes are placed crossing the suprasternal fossa during endoscopic thyroidectomy. In our clinical experience, some patients show shallow or absent suprasternal fossa, which affects the cosmetic outcome in the patient. Therefore, this study aimed to assess the feasibility and significance of restoring the suprasternal fossa by changing the position of neck drainage tubes.
Methods and Materials
A total of 117 female patients were enrolled and divided into 2 groups, including 59 and 58 individuals in the Conventional (conventional anterior neck region negative pressure drainage) and Improvement (improved method with a negative pressure drainage) groups. Then, restoration of the suprasternal fossa in all subjects was observed at 1 day postsurgery, the day of extubation, and 3 months postoperatively. In addition, drainage volume, the time to extubation, and abnormal neck sensations were compared between the groups.
Results
Compared with the Conventional group, the Improvement group showed improved restoration of the suprasternal fossa, with the patients more satisfied with the cosmetic outcome. However, operation time, postoperative drainage volume, and extubation time were not significantly different between the 2 groups.
Conclusions
In endoscopic thyroidectomy via the chest and breast approach, using the new drainage technique described here could yield improved restoration of the suprasternal fossa, ameliorating the cosmetic outcome and patient satisfaction.",2019,"However, operation time, postoperative drainage volume, and extubation time were not significantly different between the 2 groups.
","['117 female patients were enrolled and divided into 2 groups, including 59 and 58 individuals in the Conventional (conventional anterior neck region negative pressure drainage) and Improvement (improved method with a negative pressure drainage) groups']",['Drainage During Endoscopic Thyroidectomy'],"['restoration of the suprasternal fossa', 'operation time, postoperative drainage volume, and extubation time', 'drainage volume, the time to extubation, and abnormal neck sensations']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0442195', 'cui_str': 'Suprasternal (qualifier value)'}, {'cui': 'C0325079', 'cui_str': 'Cryptoprocta ferox (organism)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",117.0,0.0198888,"However, operation time, postoperative drainage volume, and extubation time were not significantly different between the 2 groups.
","[{'ForeName': 'Gao-Xiang', 'Initials': 'GX', 'LastName': 'Chen', 'Affiliation': 'Thyroid and Breast Surgery, Ningbo Medical Center Lihuili Eastern Hospital.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Thyroid and Breast Surgery, Ningbo Medical Center Lihuili Eastern Hospital.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Thyroid and Breast Surgery, Ningbo Medical Center Lihuili Eastern Hospital.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2018.00060']
1418,30878303,The Value of an Extensive Transrectal Repeat Biopsy with Anterior Sampling in Men on Active Surveillance for Low-risk Prostate Cancer: A Comparison from the Randomised Study of Active Monitoring in Sweden (SAMS).,"BACKGROUND
A systematic repeat biopsy is recommended for men starting on active surveillance for prostate cancer, but the optimal number and distribution of cores are unknown.
OBJECTIVE
To evaluate an extensive repeat transrectal biopsy with anterior sampling in men starting on active surveillance.
DESIGN, SETTING, AND PARTICIPANTS
Randomised multicentre trial. From 2012 to 2016, 340 Swedish men, aged 40-75yr, with recently diagnosed low-volume Gleason grade group 1 prostate cancer were included.
INTERVENTION
Either an extensive transrectal biopsy with anterior sampling (median 19 cores) or a standard transrectal biopsy (median 12 cores).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Primary outcome measure: Gleason grade group ≥2 cancer.
SECONDARY OUTCOMES
Cancer in anteriorly directed biopsy cores and postbiopsy infection. Nonparametric statistical tests were applied.
RESULTS AND LIMITATIONS
Gleason grade group ≥2 cancer was detected in 16% of 156 men who had an extensive biopsy and in 10% of 164 men who had a standard biopsy, a 5.7% difference (95% confidence interval [CI]-0.2% to 13%, p=0.09). There was a strong linear association between prostate-specific antigen (PSA) density and cancer in the anteriorly directed biopsy cores. The odds ratios for cancer in the anteriorly directed cores were for any cancer 2.2 (95% CI 1.3-3.9, p=0.004) and for Gleason grade group ≥2 cancer 2.3 (95% CI 1.2-4.4, p=0.015) per 0.1-ng/ml/cm 3 increments. Postbiopsy infections were equally common in the two groups. A limitation is that magnetic resonance imaging was not used.
CONCLUSIONS
The trial did not support general use of the extensive transrectal repeat biopsy template, but cancer in the anteriorly directed cores was common, particularly in men with high PSA density. The higher the PSA density, the stronger the reason to include anterior sampling at a systematic repeat biopsy.
PATIENT SUMMARY
This trial compared two different templates for transrectal prostate biopsy in men starting on active surveillance for low-risk prostate cancer. Cancer was often found in the front part of the prostate, which is not sampled on a standard prostate biopsy.",2019,There was a strong linear association between prostate-specific antigen (PSA) density and cancer in the anteriorly directed biopsy cores.,"['men starting on active surveillance for prostate cancer', 'From 2012 to 2016, 340 Swedish men, aged 40-75yr, with recently diagnosed low-volume Gleason grade group 1 prostate cancer were included', 'Sweden (SAMS', 'men starting on active surveillance', 'men starting on active surveillance for low-risk prostate cancer', 'Men on Active Surveillance for Low-risk Prostate Cancer', 'men with high PSA density']","['extensive transrectal biopsy with anterior sampling (median 19 cores) or a standard transrectal biopsy', 'transrectal prostate biopsy', 'Extensive Transrectal Repeat Biopsy with Anterior Sampling', 'extensive repeat transrectal biopsy with anterior sampling']","['biopsy cores and postbiopsy infection', 'odds ratios for cancer', 'prostate-specific antigen (PSA) density and cancer', 'Gleason grade group ≥2 cancer', 'Postbiopsy infections']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",340.0,0.174617,There was a strong linear association between prostate-specific antigen (PSA) density and cancer in the anteriorly directed biopsy cores.,"[{'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Bratt', 'Affiliation': 'Department of Urology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Electronic address: ola.bratt@vgregion.se.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Regional Cancer Centre, Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andrén', 'Affiliation': 'Department of Urology, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Carlsson', 'Affiliation': 'Section of Urology, Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Drevin', 'Affiliation': 'Regional Cancer Centre, Uppsala-Örebro, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johansson', 'Affiliation': 'Department of Urology, Academic Hospital, Uppsala, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Josefsson', 'Affiliation': 'Department of Urology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nyberg', 'Affiliation': 'Department of Urology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Sandberg', 'Affiliation': 'Department of Urology, Norrland University Hospital, Umeå, Sweden.'}, {'ForeName': 'Pär', 'Initials': 'P', 'LastName': 'Stattin', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robinsson', 'Affiliation': 'Department of Urology, Department of Urology, Jönköping County, Sweden.'}]",European urology,['10.1016/j.eururo.2019.02.035']
1419,30871947,"The effect of a new mixture of sugar and sugar-alcohols compared to sucrose and glucose on blood glucose increase and the possible adverse reactions: A phase I double-blind, three-way randomized cross-over clinical trial.","INTRODUCTION
Several sweeteners are introduced to replace sucrose in the human diet. However, they had their own limitations and concerns, particularly in terms of their taste and their long-term health consequences. This study examined the effect of a new mixture of sugars and sugar alcohol on the postprandial blood glucose levels and its possible gastrointestinal (GI) adverse reactions in human adults.
METHODS
In this double-blind three-way randomized clinical trial, adults (21 with type 2 diabetes and 20 healthy) received 300ml of three beverages containing 50g glucose, sucrose, and lacritose (a mixture of lactose, fructose, sucrose, and erythritol) when they were in the fasted state in a random order. Postprandial serum glucose was checked every 30min up to 2h and the gastrointestinal reactions were collected.
RESULTS
The mean serum glucose was significantly lower in all time points after ingestion of the lacritose for participants with type 2 diabetes compared to glucose and sucrose (P<0.05). The blood glucose levels were significantly lower in the 30th and 60th min for healthy subjects (P<0.05). Adverse GI reactions were not significant between the test beverages.
CONCLUSIONS
The ingestion of a 50g dose of lacritose containing lactose, fructose, sucrose, and erythritol, led to an improved blood glucose levels without any significant adverse effect compared to the same amount of glucose and sucrose. Studying the long-term effects of lacritose on appetite, metabolic markers and adverse reactions is recommended. The trial was registered in Iranian registry of clinical trials: IRCT2015050912571N2.",2019,The blood glucose levels were significantly lower in the 30th and 60th min for healthy subjects (P<0.05).,"['adults (21 with type 2 diabetes and 20 healthy', 'Iranian registry of clinical trials', 'human adults']","['300ml of three beverages containing 50g glucose, sucrose, and lacritose (a mixture of lactose, fructose, sucrose, and erythritol', 'new mixture of sugars and sugar alcohol', 'new mixture of sugar and sugar-alcohols compared to sucrose and glucose']","['appetite, metabolic markers and adverse reactions', 'Postprandial serum glucose', 'mean serum glucose', 'Adverse GI reactions', 'postprandial blood glucose levels and its possible gastrointestinal (GI) adverse reactions', 'blood glucose levels', 'blood glucose increase and the possible adverse reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0014757', 'cui_str': 'Erythritol'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0038654', 'cui_str': 'Alditols'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker (substance)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0595877', 'cui_str': 'Sugar blood level increased'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}]",,0.0658487,The blood glucose levels were significantly lower in the 30th and 60th min for healthy subjects (P<0.05).,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mohsenpour', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; International Branch, Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Kaseb', 'Affiliation': 'Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Nazemian', 'Affiliation': 'Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mozaffari-Khosravi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Prevention and Epidemiology of Non-Communicable Disease Research Center, Health School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: abargouei@hlth.mui.ac.ir.'}]","Endocrinologia, diabetes y nutricion",['10.1016/j.endinu.2018.12.008']
1420,30862384,"A single-blind, randomized controlled trial to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in Overactive Bladder symptoms in women responders to percutaneous tibial nerve stimulation (PTNS).","OBJECTIVES
To evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared to percutaneous tibial nerve stimulation (PTNS) in sustaining symptom improvement over a 6-month period in women with idiopathic Overactive Bladder (OAB) who had responded to an initial 12-week course of PTNS.
DESIGN
Randomized, active-controlled trial.
PARTICIPANTS
Twenty-four women diagnosed with idiopathic OAB successfully treated with PTNS were included in this study.
INTERVENTIONS
Twelve subjects were allocated to receive monthly sessions of PTNS for six months, and twelve subjects followed a flexible home-based TTNS regime after instruction on the use of a TENS device for the same follow-up time.
OUTCOMES
Participants were assessed at six weeks, three months and six months after completing the initial course of PTNS. Primary outcomes were changes from baseline in urinary frequency, number of episodes of urgency and number of episodes of urge urinary incontinence (UUI). Subjectively reported severity of symptoms and quality of life (QoL) were assessed using the validated OAB questionnaire (OAB-q).
RESULTS
Urinary frequency, episodes of urinary urgency and episodes of UUI did not change significantly between baseline and six months in either group. Similarly, OAB-q scores for severity of symptoms and QoL were maintained within both arms for the duration of the study. There were no statistically significant differences between the groups in any of the outcome measures at any of the study points.
CONCLUSION
TTNS is effective in the maintenance of symptom improvement in women with OAB who had positively responded to a course of 12 weekly PTNS sessions. The trial was registered in the Clinicaltrials.gov PRS database (Identifier: NCT02377765).",2019,"RESULTS
Urinary frequency, episodes of urinary urgency and episodes of UUI did not change significantly between baseline and six months in either group.","['Twelve subjects', 'Twenty-four women diagnosed with idiopathic OAB successfully treated with PTNS were included in this study', 'women with OAB who had positively responded to a course of 12 weekly PTNS sessions', 'women responders to percutaneous tibial nerve stimulation (PTNS', 'women with idiopathic Overactive Bladder (OAB) who had responded to an initial 12-week course of PTNS']","['flexible home-based TTNS regime', 'transcutaneous tibial nerve stimulation (TTNS', 'PTNS', 'TTNS', 'percutaneous tibial nerve stimulation (PTNS']","['Urinary frequency, episodes of urinary urgency and episodes of UUI', 'OAB-q scores for severity of symptoms and QoL', 'validated OAB questionnaire (OAB-q', 'severity of symptoms and quality of life (QoL', 'urinary frequency, number of episodes of urgency and number of episodes of urge urinary incontinence (UUI', 'Overactive Bladder symptoms']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3805249', 'cui_str': 'Percutaneous tibial nerve stimulation'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3805249', 'cui_str': 'Percutaneous tibial nerve stimulation'}]","[{'cui': 'C0042023', 'cui_str': 'Increased frequency of urination (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]",24.0,0.0882197,"RESULTS
Urinary frequency, episodes of urinary urgency and episodes of UUI did not change significantly between baseline and six months in either group.","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin-Garcia', 'Affiliation': ""Physiotherapy Department, Liverpool Women's NHS Trust, Crown Street, Liverpool, L8 7SS, UK. Electronic address: miguel.martin-garcia@lwh.nhs.uk.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Crampton', 'Affiliation': 'Department of Health Professions, Manchester Metropolitan University, Brooks Building, 53 Bonsall Street, Manchester, M15 6GX, UK. Electronic address: j.crampton@mmu.ac.uk.'}]",Physiotherapy,['10.1016/j.physio.2018.12.002']
1421,28650195,Mechanisms underlying mindfulness-based addiction treatment versus cognitive behavioral therapy and usual care for smoking cessation.,"OBJECTIVE
To examine cognitive and affective mechanisms underlying mindfulness-based addiction treatment (MBAT) versus cognitive-behavioral therapy (CBT) and usual care (UC) for smoking cessation.
METHOD
Participants in the parent study from which data were drawn (N = 412; 54.9% female; 48.2% African American, 41.5% non-Latino White, 5.4% Latino, 4.9% other; 57.6% annual income <$30,000) were randomized to MBAT (n = 154), CBT (n = 155), or UC (n = 103). From quit date through 26 weeks postquit, participants completed measures of emotions, craving, dependence, withdrawal, self-efficacy, and attentional bias. Biochemically confirmed 7-day smoking abstinence was assessed at 4 and 26 weeks postquit. Although the parent study did not find a significant treatment effect on abstinence, mixed-effects regression models were conducted to examine treatment effects on hypothesized mechanisms, and indirect effects of treatments on abstinence were tested.
RESULTS
Participants receiving MBAT perceived greater volitional control over smoking and evidenced lower volatility of anger than participants in both other treatments. However, there were no other significant differences between MBAT and CBT. Compared with those receiving UC, MBAT participants reported lower anxiety, concentration difficulties, craving, and dependence, as well as higher self-efficacy for managing negative affect without smoking. Indirect effects of MBAT versus UC on abstinence occurred through each of these mechanisms.
CONCLUSIONS
Whereas several differences emerged between MBAT and UC, MBAT and CBT had similar effects on several of the psychosocial mechanisms implicated in tobacco dependence. Results help to shed light on similarities and differences between mindfulness-based and other active smoking cessation treatments. (PsycINFO Database Record",2017,"Whereas several differences emerged between MBAT and UC, MBAT and CBT had similar effects on several of the psychosocial mechanisms implicated in tobacco dependence.","['Participants in the parent study from which data were drawn (N = 412; 54.9% female; 48.2% African American, 41.5% non-Latino White, 5.4% Latino, 4.9% other; 57.6% annual income']","['MBAT versus UC', 'CBT', 'mindfulness-based addiction treatment (MBAT) versus cognitive-behavioral therapy (CBT) and usual care (UC', 'MBAT', 'mindfulness-based addiction treatment versus cognitive behavioral therapy and usual care for smoking cessation']","['lower anxiety, concentration difficulties, craving, and dependence', '7-day smoking abstinence', 'volatility of anger', 'emotions, craving, dependence, withdrawal, self-efficacy, and attentional bias']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1959569', 'cui_str': 'Volatility'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}]",30000.0,0.0216332,"Whereas several differences emerged between MBAT and UC, MBAT and CBT had similar effects on several of the psychosocial mechanisms implicated in tobacco dependence.","[{'ForeName': 'Claire Adams', 'Initials': 'CA', 'LastName': 'Spears', 'Affiliation': 'Division of Health Promotion and Behavior, Georgia State University School of Public Health.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Natalie K', 'Initials': 'NK', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, Catholic University of America.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Houchins', 'Affiliation': 'Department of Psychology, Catholic University of America.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vinci', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center.'}, {'ForeName': 'Diana Stewart', 'Initials': 'DS', 'LastName': 'Hoover', 'Affiliation': 'Department of Health Disparities Research, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Jennifer Irvin', 'Initials': 'JI', 'LastName': 'Vidrine', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Waters', 'Affiliation': 'Department Medical and Clinical Psychology, Uniformed Services University of the Health Sciences.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wetter', 'Affiliation': 'Department of Population Health Sciences, University of Utah.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000229']
1422,29604186,"Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β Receptor Fusion Protein, in Primary Sjögren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial.","OBJECTIVE
To evaluate the clinical efficacy and safety of baminercept, a lymphotoxin β receptor IgG fusion protein (LTβR-Ig), for the treatment of primary Sjögren's syndrome (SS), and to explore the possible mechanisms of action of this treatment.
METHODS
In this multicenter trial, 52 patients with primary SS were randomized in a 2:1 ratio to receive subcutaneous injections of 100 mg of baminercept every week for 24 weeks or matching placebo. The primary end point was the change between screening and week 24 in the stimulated whole salivary flow (SWSF) rate. Secondary end points included the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), as well as measurements of select chemokines and cytokines and enumeration of peripheral blood B and T cell subsets.
RESULTS
The change from baseline to week 24 in the SWSF rate was not significantly different between the baminercept and placebo treatment groups (baseline-adjusted mean change -0.01 versus 0.07 ml/minute; P = 0.332). The change in the ESSDAI during treatment was also not significantly different between the treatment groups (baseline-adjusted mean change -1.23 versus -0.15; P = 0.104). Although the incidence of adverse events was similar between the treatment groups, baminercept therapy was associated with a higher incidence of liver toxicity, including 2 serious adverse events. Baminercept also produced a significant decrease in plasma levels of CXCL13 and significant changes in the number of circulating B and T cells, consistent with its known inhibitory effects on LTβR signaling.
CONCLUSION
In this trial, treatment with baminercept failed to significantly improve glandular and extraglandular disease in patients with primary SS, despite evidence from mechanistic studies showing that it blocks LTβR signaling.",2018,The change from baseline to week 24 in the SWSF rate was not significantly different between the baminercept and placebo treatment groups (baseline-adjusted mean change -0.01 versus 0.07 ml/minute; P = 0.332).,"['52 patients with primary SS', ""primary Sjögren's syndrome (SS"", ""Primary Sjögren's Syndrome"", 'patients with primary SS']","['subcutaneous injections of 100 mg of baminercept every week for 24 weeks or matching placebo', 'placebo', 'Placebo', 'baminercept, a lymphotoxin β receptor IgG fusion protein (LTβR-Ig', 'Baminercept, a Lymphotoxin β Receptor Fusion Protein']","['stimulated whole salivary flow (SWSF) rate', 'SWSF rate', 'adverse events', 'glandular and extraglandular disease', 'plasma levels of CXCL13', 'number of circulating B and T cells', ""European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), as well as measurements of select chemokines and cytokines and enumeration of peripheral blood B and T cell subsets"", 'liver toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome (disorder)""}]","[{'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4043327', 'cui_str': 'baminercept'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024320', 'cui_str': 'Tumor Necrosis Factor Ligand Superfamily Member 1'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein product'}]","[{'cui': 'C0429177', 'cui_str': 'Salivary flow rate (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0225353', 'cui_str': 'Glandular (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C1527336', 'cui_str': ""Sjogren's Syndrome""}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C2362651', 'cui_str': 'T cell subsets'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",52.0,0.268314,The change from baseline to week 24 in the SWSF rate was not significantly different between the baminercept and placebo treatment groups (baseline-adjusted mean change -0.01 versus 0.07 ml/minute; P = 0.332).,"[{'ForeName': 'E William', 'Initials': 'EW', 'LastName': 'St Clair', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Baer', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Chungwen', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Ignacio Sanz, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Ghaith', 'Initials': 'G', 'LastName': 'Noaiseh', 'Affiliation': 'UPMC Presbyterian, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Parke', 'Affiliation': 'Saint Francis Medical Group, Hartford, Connecticut.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Coca', 'Affiliation': 'University of Rochester, Rochester, New York.'}, {'ForeName': 'Tammy O', 'Initials': 'TO', 'LastName': 'Utset', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wallace', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McNamara', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': 'Rho, Inc., Chapel Hill, North Carolina.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho, Inc., Chapel Hill, North Carolina.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Browning', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Franchimont', 'Affiliation': 'Biogen, Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Emory Healthcare, Atlanta, Georgia.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Guthridge', 'Affiliation': 'Oklahoma Medical Research Foundation, Oklahoma City.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Sanz', 'Affiliation': 'Ignacio Sanz, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'James', 'Affiliation': 'Oklahoma Medical Research Foundation, Oklahoma City.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.40513']
1423,30859220,Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I.,"AIMS
To assess the impact of MultiPoint™ Pacing (MPP)-programmed according to the physician's discretion-in non-responders to standard biventricular pacing after 6 months.
METHODS AND RESULTS
The study enrolled 1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy. A core laboratory assessed echocardiography at baseline and 6 months and defined volumetric non-response to biventricular pacing as <15% reduction in left ventricular end-systolic volume (LVESV). Clinical sites randomized patients classified as non-responders in a 1:1 ratio to receive MPP (236 patients) or continued biventricular pacing (231 patients) for an additional 6 months and evaluated rate of conversion to echocardiographic response. Baseline characteristics of both groups were comparable. No difference was observed in non-responder to responder conversion rate between MPP and biventricular pacing (31.8% and 33.8%, P = 0.72). In the MPP arm, 68 (29%) patients received MPP programmed with a wide LV electrode anatomical separation (≥30 mm) and shortest LV1-LV2 and LV2-RV timing delays (MPP-AS); 168 (71%) patients received MPP programmed with other settings (MPP-Other). MPP-AS elicited a significantly higher non-responder conversion rate compared to MPP-Other (45.6% vs. 26.2%, P = 0.006) and a trend in a higher conversion rate compared to biventricular pacing (45.6% vs. 33.8%, P = 0.10).
CONCLUSIONS
After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.",2019,"After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.","['236 patients) or', '1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy']","['MPP', 'Cardiac resynchronization therapy', 'MultiPoint™ Pacing (MPP)-programmed', 'continued biventricular pacing']","['echocardiographic response', 'conversion rate', 'non-responder to responder conversion rate between MPP and biventricular pacing', 'left ventricular end-systolic volume (LVESV', 'rate of conversion to echocardiographic response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0623363', 'cui_str': 'MPPS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0623363', 'cui_str': 'MPPS'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2936372', 'cui_str': 'Atrio-Biventricular Pacing'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0623363', 'cui_str': 'MPPS'}, {'cui': 'C2936372', 'cui_str': 'Atrio-Biventricular Pacing'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}]",1921.0,0.0339216,"After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'Université de Rennes I, CICIT 804, Rennes, CHU Pontchaillou, Rennes, France.'}, {'ForeName': 'Haran', 'Initials': 'H', 'LastName': 'Burri', 'Affiliation': 'University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Curnis', 'Affiliation': 'Università degli Studi di Brescia, Brescia, Italy.'}, {'ForeName': 'Peter Paul', 'Initials': 'PP', 'LastName': 'Delnoy', 'Affiliation': 'Isala Klinieken, Zwolle, The Netherlands.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Rinaldi', 'Affiliation': ""King's College, London, UK.""}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Sperzel', 'Affiliation': 'Kerckhoff Klinik, Bad Nauheim, Germany.'}, {'ForeName': 'Kwangdeok', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Abbott, Plano, TX, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Calò', 'Affiliation': 'Policlinico Casilino, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Vicentini', 'Affiliation': 'Casa di Cura Dott, Pederzoli, Italy.'}, {'ForeName': 'Joaquin Fernandez', 'Initials': 'JF', 'LastName': 'Concha', 'Affiliation': 'Hospital Universitario Infanta Cristina, Spain.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Thibault', 'Affiliation': 'Université de Montréal, Montreal, Canada.'}]",European heart journal,['10.1093/eurheartj/ehz109']
1424,30738780,"Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND
Abiraterone acetate plus prednisone or prednisolone improves progression-free survival and overall survival in patients with metastatic castration-resistant prostate cancer. Radium-223 improves overall survival and delays the onset of symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases. We assessed concurrent treatment with abiraterone acetate plus prednisone or prednisolone and radium-223 in such patients.
METHODS
We did a randomised, double-blind, placebo-controlled, phase 3 trial at 165 oncology and urology centres in 19 countries. Eligible patients were aged 18 years or older, and had histologically confirmed, progressive, chemotherapy-naive, asymptomatic or mildly symptomatic castration-resistant prostate cancer and bone metastases, Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 6 months, and adequate haematological, renal, and liver function. Participants were randomly assigned (1:1) according to a permuted block design (block size 4) via interactive response technology to receive up to six intravenous injections of radium-223 (55 kBq/kg) or matching placebo once every 4 weeks. All patients were also scheduled to receive oral abiraterone acetate 1000 mg once daily plus oral prednisone or prednisolone 5 mg twice daily during and after radium-223 or placebo treatment. The primary endpoint was symptomatic skeletal event-free survival, which was assessed in the intention-to-treat population. Safety analyses were done in all patients who received at least one dose of any study drug. This trial is registered with ClinicalTrials.gov, number NCT02043678. Enrolment has been completed, and follow-up is ongoing.
FINDINGS
Between March 30, 2014, and Aug 12, 2016, 806 patients were randomly assigned to receive radium-223 (n=401) or placebo (n=405) in addition to abiraterone acetate plus prednisone or prednisolone. The study was unblinded prematurely, on Nov 17, 2017, after more fractures and deaths were noted in the radium-223 group than in the placebo group (in an unplanned ad-hoc analysis), but all patients had completed radium-223 or placebo before this date. At the primary analysis (data cutoff Feb 15, 2018), 196 (49%) of 401 patients in radium-223 group had had at least one symptomatic skeletal event or died, compared with 190 (47%) of 405 patients in the placebo group (median follow-up 21·2 months [IQR 17·0-25·8]). Median symptomatic skeletal event-free survival was 22·3 months (95% CI 20·4-24·8) in the radium-223 group and 26·0 months (21·8-28·3) in the placebo group (hazard ratio 1·122 [95% CI 0·917-1·374]; p=0·2636). Fractures (any grade) occurred in 112 (29%) of 392 patients in the radium-223 group and 45 (11%) of 394 patients in the placebo group. The most common grade 3-4 treatment-emergent adverse events were hypertension (43 [11%] patients in the radium-223 group vs 52 [13%] patients in the placebo group), fractures (36 [9%] vs 12 [3%]) and increased alanine aminotransferase concentrations (34 [9%] vs 28 [7%]). Serious treatment-emergent adverse events occurred in 160 (41%) patients in the radium-223 group and 155 (39%) in the placebo group. Treatment-related deaths occurred in two (1%) patients in the radium-223 group (acute myocardial infarction and interstitial lung disease) and one (<1%) in the placebo group (arrhythmia).
INTERPRETATION
The addition of radium-223 to abiraterone acetate plus prednisone or prednisolone did not improve symptomatic skeletal event-free survival in patients with castration-resistant prostate cancer and bone metastases, and was associated with an increased frequency of bone fractures compared with placebo. Thus, we do not recommend use of this combination.
FUNDING
Bayer.",2019,Median symptomatic skeletal event-free survival was 22·3 months (95% CI 20·4-24·8) in the radium-223 group and 26·0 months (21·8-28·3) in the placebo group (hazard ratio,"['Eligible patients were aged 18 years or older, and had histologically confirmed, progressive, chemotherapy-naive, asymptomatic or mildly symptomatic castration-resistant prostate cancer and bone metastases', 'Between March 30, 2014, and Aug 12, 2016, 806 patients', 'patients with castration-resistant prostate cancer and bone metastases (ERA 223', '165 oncology and urology centres in 19 countries', 'patients with castration-resistant prostate cancer and bone metastases', 'patients with metastatic castration-resistant prostate cancer']","['permuted block design (block size 4) via interactive response technology to receive up to six intravenous injections of radium-223 (55 kBq/kg) or matching placebo', 'abiraterone acetate plus prednisone or prednisolone and radium-223', 'radium-223 or placebo', 'placebo', 'oral abiraterone acetate 1000 mg once daily plus oral prednisone or prednisolone', 'Abiraterone acetate plus prednisone or prednisolone', 'Radium-223', 'abiraterone acetate plus prednisone or prednisolone', 'radium-223', 'radium-223 to abiraterone acetate and prednisone or prednisolone']","['symptomatic skeletal event-free survival', 'frequency of bone fractures', 'symptomatic skeletal event or died', 'adequate haematological, renal, and liver function', 'progression-free survival and overall survival', 'fractures and deaths', 'Serious treatment-emergent adverse events', 'alanine aminotransferase concentrations', 'deaths', 'overall survival', 'Median symptomatic skeletal event-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}, {'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C0560040', 'cui_str': 'kBq'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",806.0,0.756152,Median symptomatic skeletal event-free survival was 22·3 months (95% CI 20·4-24·8) in the radium-223 group and 26·0 months (21·8-28·3) in the placebo group (hazard ratio,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA. Electronic address: smith.matthew@mgh.harvard.edu.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden NHS Foundation Trust and Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'University of Montreal Hospital Center, Montreal, QC, Canada.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Charité Berlin, Berlin, Germany.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Quan Sing', 'Initials': 'QS', 'LastName': 'Ng', 'Affiliation': 'National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Boegemann', 'Affiliation': 'University of Muenster Medical Center, Muenster, Germany.'}, {'ForeName': 'Vsevolod', 'Initials': 'V', 'LastName': 'Matveev', 'Affiliation': 'N N Blokhin Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Piulats', 'Affiliation': 'Catalan Cancer Institute, IDIBELL, CIBERONC, Barcelona, Spain.'}, {'ForeName': 'Luis Eduardo', 'Initials': 'LE', 'LastName': 'Zucca', 'Affiliation': 'Barretos Cancer Hospital, Barretos, Brazil.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Karyakin', 'Affiliation': 'Medical Radiological Research Center, Kaluga, Russia.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Kimura', 'Affiliation': 'Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'William Carlos', 'Initials': 'WC', 'LastName': 'Nahas', 'Affiliation': 'Instituto Do Cancer Do Estado De Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Nolè', 'Affiliation': 'IEO, Istituto Europeo di Oncologia, IRCCS, Milan, Italy.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Rosenbaum', 'Affiliation': 'Rabin Medical Center Davidoff Center, Petach-Tikva, Israel.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heidenreich', 'Affiliation': 'University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Kakehi', 'Affiliation': 'Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Amily', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Krissel', 'Affiliation': 'Bayer, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Teufel', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Junwu', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Wagner', 'Affiliation': 'Bayer Consumer Care, Basel, Switzerland.'}, {'ForeName': 'Celestia', 'Initials': 'C', 'LastName': 'Higano', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30860-X']
1425,30795944,Depression Agency-Based Collaborative: Effect of Problem-Solving Therapy on Risk of Common Mental Disorders in Older Adults With Home Care Needs.,"BACKGROUND
Interventions to prevent depression in older adults have mainly focused on young-old ambulatory adults, not on the old-old with disabilities who receive supportive services in their homes.
OBJECTIVE
The Depression Agency-Based Collaborative (Dep-ABC) is a single-blind pilot randomized controlled trial assessing the effect of an intervention-development strategy using problem-solving therapy (PST) on the risk of common mental health disorders in this vulnerable population.
METHODS
The intervention involved six to eight sessions of PST over 12 weeks. Participants were followed up to 12 months postintervention.
RESULTS
Dep-ABC randomized 104 participants-68.4% of eligible and 17.5% of all older adults screened. The proportion of participants with incident major depressive disorder or generalized anxiety disorder was 11.4% in PST and 14.3% in the enhanced usual care control arm. A test of the interaction between time and intervention for anxiety symptoms favored the PST arm (p = 0.04).
CONCLUSION
PST did not lower the risk of incident common mental illness but did lower anxiety symptom burden. Apart from low power, the effects of PST may have been blunted by referral for medical and aging services in the enhanced usual care group.",2019,"A test of the interaction between time and intervention for anxiety symptoms favored the PST arm (p = 0.04).
","['Older Adults With Home Care Needs', 'young-old ambulatory adults, not on the old-old with disabilities who receive supportive services in their homes', 'older adults']","['Problem-Solving Therapy', 'intervention-development strategy using problem-solving therapy (PST', 'PST', 'Depression Agency-Based Collaborative (Dep-ABC']","['risk of incident common mental illness', 'anxiety symptoms', 'generalized anxiety disorder']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0001795', 'cui_str': 'Oldest Old'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]",104.0,0.0916943,"A test of the interaction between time and intervention for anxiety symptoms favored the PST arm (p = 0.04).
","[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Sciences (SMA, JK), Graduate School of Public Health, University of Pittsburgh, Pittsburgh. Electronic address: smalbert@pitt.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'King', 'Affiliation': 'Department of Behavioral and Community Health Sciences (SMA, JK), Graduate School of Public Health, University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics (SA, MAD, JZ), University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Mary Amanda', 'Initials': 'MA', 'LastName': 'Dew', 'Affiliation': 'Department of Biostatistics (SA, MAD, JZ), University of Pittsburgh, Pittsburgh; Department of Psychiatry (MAD, STS, JFK, AGG, MAB, CFR), University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics (SA, MAD, JZ), University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Stahl', 'Affiliation': 'Department of Psychiatry (MAD, STS, JFK, AGG, MAB, CFR), University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry (MAD, STS, JFK, AGG, MAB, CFR), University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Ariel G', 'Initials': 'AG', 'LastName': 'Gildengers', 'Affiliation': 'Department of Psychiatry (MAD, STS, JFK, AGG, MAB, CFR), University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'Department of Psychiatry (MAD, STS, JFK, AGG, MAB, CFR), University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds Iii', 'Affiliation': 'Department of Psychiatry (MAD, STS, JFK, AGG, MAB, CFR), University of Pittsburgh, Pittsburgh.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.01.002']
1426,30829892,High-fidelity Training Model for Measurement of Dynamic Optic Nerve Sheath Diameter Using Transorbital Ultrasonography.,"BACKGROUND
Transorbital ultrasonographic measurement of optic nerve sheath diameter (ONSD) is an important technique for bedside assessment of raised intracranial pressure (ICP). However, developing competency for this clinical skill requires practice scans on both normal subjects and patients with raised ICP. The aim of this study is to develop a high-fidelity training model capable of measuring dynamic changes in ONSD and to test the reliability and reproducibility of the model at different simulated ICP values.
MATERIALS AND METHODS
We designed and developed a high-fidelity training model for dynamic ONSD measurement using a hemispherical table tennis ball, mounted on a 3.0-mm pediatric microcuffed endotracheal tube (ETT). Two independent investigators then performed a randomized blinded study to assess the reliability and reproducibility of the model. A total of 30 ONSD measurements (10 measurements each for 3 ETT cuff volumes of 0.1, 0.2, and 0.3 mL, simulating an ONSD of a normal, borderline, and raised ICP, respectively) were performed by each investigator. Intraclass correlation coefficients and Bland-Altman plots were calculated to analyze the level of agreement between the investigators.
RESULTS
Our model was able to provide dynamic changes in ONSD secondary to ETT cuff volume changes. Small increments of 0.1 mL cuff volume changes produced immediate changes in ONSD that are similar to those observed in patients. The median interobserver difference in ONSD was 0.3 mm (interquartile range, 0. to 0.4 mm). Intraclass correlation coefficient was 0.89, 0.89, and 0.90 for 0.1, 0.2, and 0.3 mL ETT cuff volumes, respectively.
CONCLUSIONS
We have developed a clinically relevant model capable of simulating changes in ONSD in patients with normal and raised ICP. This model could be a valuable training tool to gain scanning experience in optic nerve ultrasonography, and improve operators' technical abilities.",2020,"The median interobserver difference in ONSD was 0.3 mm (interquartile range, 0.","['normal subjects and patients with raised ICP', 'patients with normal and raised ICP']","['hemispherical table tennis ball, mounted on a 3.0-mm pediatric microcuffed endotracheal tube (ETT', 'optic nerve sheath diameter (ONSD']","['Dynamic Optic Nerve Sheath Diameter', 'median interobserver difference in ONSD']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}]","[{'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0336994', 'cui_str': 'Tennis ball, device (physical object)'}, {'cui': 'C0181909', 'cui_str': 'Mount (physical object)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0410696,"The median interobserver difference in ONSD was 0.3 mm (interquartile range, 0.","[{'ForeName': 'Zakir', 'Initials': 'Z', 'LastName': 'Hajat', 'Affiliation': 'Department of Anesthesia, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dinsmore', 'Affiliation': ''}, {'ForeName': 'Lashmi', 'Initials': 'L', 'LastName': 'Venkatraghavan', 'Affiliation': ''}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000592']
1427,31066871,Update on Clinical Trials of Losartan With and Without β-Blockers to Block Aneurysm Growth in Patients With Marfan Syndrome: A Review.,"Importance
Thoracic aortic aneurysms leading to acute aortic dissections are a major cause of morbidity and mortality despite significant advances in surgical treatment, which remains the main intervention to prevent type A dissections. In the past 2 decades progress has been made toward a better understanding of molecular mechanisms that lead to aneurysm formation and dissections of the thoracic aorta. This focused review emphasizes the results of clinical trials using β-blocker, losartan potassium, and irbesartan in patients with Marfan syndrome and comments briefly on mechanisms of aortic remodeling, including fibrosis and transforming growth factor β signaling.
Observation
The major risk factors for the disease are increased hemodynamic forces, typically owing to poorly controlled hypertension, and heritable genetic variants. The altered genes predisposing to thoracic aortic disease have been shown or are predicted to decrease vascular smooth muscle cell contraction, decrease transforming growth factor β signaling, or alter the extracellular matrix. Preclinical models of Marfan syndrome showed promising results for losartan as a potential therapy to attenuate aortic dilation in mice. However, several clinical trials did not conclusively confirm that losartan attenuated aortic aneurysm expansion better than β-blockers. Most importantly, clinical trials assessing whether losartan therapy not only reduces aortic growth but also improves adverse aortic outcomes, including dissection, need for surgery, and death, have not been conducted. The largest trial to date to our knowledge, the Pediatric Heart Network trial, sponsored by the National Heart, Lung, and Blood Institute, showed a nonsignificant increase in adverse aortic outcomes, with almost a doubling of adverse events in patients randomized to losartan treatment compared with β-blockers, suggesting that this study was underpowered to assess adverse aortic outcomes. On the other hand, the evidence for β-blocker therapy to reduce morbidity and mortality in Marfan syndrome is limited to a single small, prospective randomized and nonblinded clinical trial.
Conclusions and Relevance
Taken together, these data emphasize the need for clinical trials adequately powered to assess both aortic aneurysm growth and adverse aortic outcomes to identify effective medical therapies for Marfan syndrome and other aortopathies.",2019,In the past 2 decades progress had been made toward a better understanding of molecular mechanisms that lead to aneurysm formation and dissections of the thoracic aorta.,"['patients with Marfan syndrome', 'Patients With Marfan Syndrome']","['β-blocker, losartan potassium, and irbesartan', 'Losartan With and Without β-Blockers', 'losartan']","['aortic growth', 'adverse aortic outcomes, including dissection, need for surgery, and death', 'morbidity and mortality', 'adverse aortic outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024796', 'cui_str': 'Marfan Syndrome, Type I'}]","[{'cui': 'C0700492', 'cui_str': 'Losartan Potassium'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0465676,In the past 2 decades progress had been made toward a better understanding of molecular mechanisms that lead to aneurysm formation and dissections of the thoracic aorta.,"[{'ForeName': 'Marion A', 'Initials': 'MA', 'LastName': 'Hofmann Bowman', 'Affiliation': 'Frankel Cardiovascular Center, University of Michigan, Ann Arbor.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Eagle', 'Affiliation': 'Frankel Cardiovascular Center, University of Michigan, Ann Arbor.'}, {'ForeName': 'Dianna M', 'Initials': 'DM', 'LastName': 'Milewicz', 'Affiliation': 'McGovern Medical School, University of Texas Health Science Center at Houston.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1176']
1428,30857952,"To Cement or Not? Five-Year Results of a Prospective, Randomized Study Comparing Cemented vs Cementless Total Knee Arthroplasty.","BACKGROUND
The optimal mode of fixation in total knee arthroplasty is a continuing subject of debate.
METHODS
Previously, we reported 2-year results for this prospective, randomized trial. Knee Society Scores, Oxford scores, and pain visual analog scales were collected pre-operatively and post-operatively. Minimum 5-year follow-up has been obtained with radiographic analysis for 85 patients.
RESULTS
Mean Knee Society Scores and Oxford scores and patient-reported outcomes were similar in both groups. Each group had 1 additional revision, but neither was related to implant fixation. Survivorship with revision as an endpoint was equivalent (95.9% and 95.3%, P = .98). There was no significant difference in radiolucencies observed between groups (P = .10), all were non-progressive.
CONCLUSION
Cementless and cemented total knee arthroplasty had equivalent patient-reported outcomes and survivorship at midterm follow-up. Updates are planned at 10 and 15-year intervals to observe long-term modes of failure between these 2 methods of fixation.",2019,"There was no significant difference in radiolucencies observed between groups (P = .10), all were non-progressive.
CONCLUSION
Cementless and cemented total knee arthroplasty had equivalent patient-reported outcomes and survivorship at midterm follow-up.",['85 patients'],[],"['radiolucencies', 'Knee Society Scores, Oxford scores, and pain visual analog scales', 'Mean Knee Society Scores and Oxford scores and patient-reported outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",85.0,0.0868731,"There was no significant difference in radiolucencies observed between groups (P = .10), all were non-progressive.
CONCLUSION
Cementless and cemented total knee arthroplasty had equivalent patient-reported outcomes and survivorship at midterm follow-up.","[{'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Fricka', 'Affiliation': 'Anderson Orthopaedic Research Institute, Inova Center for Joint Replacement at Inova Mount Vernon Hospital, Alexandria, VA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McAsey', 'Affiliation': 'Anderson Orthopaedic Research Institute, Inova Center for Joint Replacement at Inova Mount Vernon Hospital, Alexandria, VA.'}, {'ForeName': 'Supatra', 'Initials': 'S', 'LastName': 'Sritulanondha', 'Affiliation': 'Anderson Orthopaedic Research Institute, Inova Center for Joint Replacement at Inova Mount Vernon Hospital, Alexandria, VA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.024']
1429,30847561,The effectiveness of inositol and metformin on infertile polycystic ovary syndrome women with resistant to letrozole.,"PURPOSE
The purpose is a comparison of effectiveness of myo-inositol and metformin in infertile women with polycystic ovary syndrome (PCOS) treated with letrozole.
METHODS
This study is a randomized single-blind controlled clinical trial undertaken in 150 infertile PCOS women. For all patients, letrozole is prescribed at a dose of 7.5 mg per day from the third day of menstruation for 5 days. Patients who did not ovulate were included and divided into three pretreatment groups: group I(control group), 200 µg of folic acid (as a placebo); group II, 1500 mg of metformin daily plus 200 µg of folic acid, and group III, inositol 2 g plus 200 µg of folic acid received twice daily for 3 months. In the last cycle, 7.5 mg letrozole was prescribed for the induction of ovulation. Primary outcomes were ovary function and pregnancy.
RESULTS
The ovarian function was not significantly different in those groups, whereas the ovarian function of inositol + folic acid group in normal BMI found significantly higher than other BMI spectra. In addition, the ovarian function is significantly higher in the inositol + folic acid group by increasing the infertility duration. The incidence of pregnancy is lower in letrozole + folic acid + inositol group than the other groups; however, it is not significant.
CONCLUSION
The addition of inositol and metformin to the treatment of infertile PCOS women with letrozole resistance improves the ovarian function; however, it is not significant. Of note, inositol was more effective than metformin in patients with normal BMI.
IRCT REGISTRATION NUMBER
IRCT2017070234845N1.",2019,"The incidence of pregnancy is lower in letrozole + folic acid + inositol group than the other groups; however, it is not significant.
","['patients with normal BMI', '150 infertile PCOS women', 'infertile polycystic ovary syndrome women with resistant to', 'infertile PCOS women with', 'infertile women with polycystic ovary syndrome (PCOS) treated with', 'Patients who did not ovulate']","['letrozole + folic acid + inositol', 'metformin', 'letrozole resistance', 'inositol + folic acid', 'myo-inositol and metformin', 'inositol and metformin', 'folic acid', '200\xa0µg of folic acid (as a placebo', 'letrozole', 'metformin daily plus 200\xa0µg of folic acid, and group III, inositol 2']","['ovary function and pregnancy', 'incidence of pregnancy', 'infertility duration', 'ovarian function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",150.0,0.0597243,"The incidence of pregnancy is lower in letrozole + folic acid + inositol group than the other groups; however, it is not significant.
","[{'ForeName': 'Sajadeh', 'Initials': 'S', 'LastName': 'Pourghasem', 'Affiliation': 'Mother and Child Welfare Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bazarganipour', 'Affiliation': 'Midwifery Department, School of Medicine, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Seyed Abdolvahab', 'Initials': 'SA', 'LastName': 'Taghavi', 'Affiliation': 'Gynecologic and Obstetrics Department, School of Medicine, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Maryam Azizi', 'Initials': 'MA', 'LastName': 'Kutenaee', 'Affiliation': 'Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. Maryamazizikut86@gmail.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05064-5']
1430,32022282,"A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.","AIMS
Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim) is indicated for the reduction of chemotherapy-induced neutropenia and prevention of febrile neutropenia. Biosimilar pegfilgrastim is expected to reduce the financial burden of this complication of chemotherapy. The aim of this study was to demonstrate biosimilarity between Sandoz biosimilar pegfilgrastim and its US- and EU-approved reference biologics.
METHODS
Phase I, randomized, double-blind, single-dose, 3-period, 6-sequence cross-over, multicentre study to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of Sandoz biosimilar pegfilgrastim with US- and EU-references in healthy adults.
RESULTS
Pharmacokinetic and pharmacodynamic similarity was demonstrated between the 3 biologics, as the 90% confidence interval for all primary pharmacokinetic and pharmacodynamic endpoint comparisons were contained within the predefined similarity margins of 0.80-1.25. Safety, immunogenicity and tolerability were also similar.
CONCLUSIONS
Sandoz biosimilar pegfilgrastim demonstrated pharmacokinetic and pharmacodynamic similarity to both US- and EU-reference biologics. No meaningful differences in safety, local tolerability and immunogenicity were identified.",2020,"No meaningful differences in safety, local tolerability, and immunogenicity were identified.","['healthy adults', 'healthy volunteers']","['Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim', 'Sandoz biosimilar pegfilgrastim with US- and EU-references', 'pegfilgrastim biosimilar with its US- and EU-reference biologics', 'Biosimilar pegfilgrastim']","['pharmacokinetics, pharmacodynamics, safety, and immunogenicity', 'Pharmacokinetic (PK) and pharmacodynamic (PD) similarity', 'safety, local tolerability, and immunogenicity', 'Safety, immunogenicity, and tolerability']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]",,0.248203,"No meaningful differences in safety, local tolerability, and immunogenicity were identified.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellon', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Novartis, Princeton, NJ, USA.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Skerjanec', 'Affiliation': 'Sandoz AG, Novartis, Basel, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Velinova', 'Affiliation': 'PRAHS, Groningen, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dickerson', 'Affiliation': 'PRAHS, Lenexa, KS, USA.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Sabet', 'Affiliation': 'PRAHS, Salt Lake City, UT, USA.'}, {'ForeName': 'Ly', 'Initials': 'L', 'LastName': 'Ngo', 'Affiliation': 'PRAHS, Marlton, NJ, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion, Tempe, AZ, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tomek', 'Affiliation': 'Celerion, Lincoln, NE, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Schussler', 'Affiliation': 'Novartis, Princeton, NJ, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schier-Mumzhiu', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Gattu', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Sven D', 'Initials': 'SD', 'LastName': 'Koch', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Schelcher', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Miryana', 'Initials': 'M', 'LastName': 'Dobreva', 'Affiliation': 'Sandoz, Novartis, Sofia, Bulgaria.'}, {'ForeName': 'Anca', 'Initials': 'A', 'LastName': 'Boldea', 'Affiliation': 'Sandoz Pharma Services Romania SRL, Novartis, Bucharest, Romania.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Nakov', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Gordon P', 'Initials': 'GP', 'LastName': 'Otto', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14226']
1431,31702992,Pressure Injuries Treated With Anodal and Cathodal High-voltage Electrical Stimulation: the Effect on Blood Serum Concentration of Cytokines and Growth Factors in Patients With Neurological Injuries. A Randomized Clinical Study.,"It remains unclear whether electrical currents can affect biological factors that determine chronic wound healing in humans.
PURPOSE
The aim of this study was to determine whether anodal and cathodal high-voltage monophasic pulsed currents (HVMPC) provided to the area of a pressure injury (PI) change the blood level of cytokines (interleukin [IL]-1β, IL-10, and tumor necrosis factor [TNF]-α) and growth factors (insulin-like growth factor [IGF]-1 and transforming growth factor [TGF]-β1) in patients with neurological injuries and whether the level of circulatory cytokines and growth factors correlates with PI healing progression.
METHODS
This study was part of a randomized clinical trial on the effects of HVMPC on PI healing. All patients with neurological injuries (spinal cord injury, ischemic stroke, and blunt trauma to the head) and a stage 2, stage 3, or stage 4 PI of at least 4 weeks' duration hospitalized in one rehabilitation center were eligible to participate if older than 18 years of age and willing to consent to donating blood samples. Exclusion criteria included local contraindications to electrical stimulation (cancer, electronic implants, osteomyelitis, tunneling, necrotic wounds), PIs requiring surgical intervention, patients with poorly controlled diabetes mellitus (HbA1C > 7%), critical wound infection, and/or allergies to standard wound treatment. Participants were randomly assigned to 1 of 3 groups: anodal (AG) or cathodal (CG) HVMPC treatment (154 μs; 100 Hz; 360 µC/sec; 1.08 C/day) or a placebo (PG, sham) applied for 50 minutes a day, 5 days per week, for 8 weeks. TNF-α, IL-1β, IL-10, TGF-β1, and IGF-1 levels in blood serum were assessed using the immunoenzyme method (ELISA) and by chemiluminescence, respectively, at baseline and week 4. Wound surface area measurements were obtained at baseline and week 4 and analyzed using a digitizer connected to a personal computer. Statistical analyses were performed using the maximum-likelihood chi-squared test, the analysis of variance Kruskal-Wallis test, the Kruskal-Wallis post-hoc test, and Spearman's rank order correlation; the level of significance was set at P ≤.05.
RESULTS
Among the 43 participants, 15 were randomized to AG (mean age 53.87 ± 13.30 years), 13 to CG (mean age 51.08 ± 20.43 years), and 15 to PG treatment (mean age 51.20 ± 14.47 years). Most PIs were located in the sacral region (12, 74.42%) and were stage 3 (11, 67.44%). Wound surface area baseline size ranged from 1.00 cm2 to 58.04 cm2. At baseline, none of the variables were significantly different. After 4 weeks, the concentration of IL-10 decreased in all groups (AG: 9.8%, CG: 38.54%, PG: 27.42%), but the decrease was smaller in the AG than CG group (P = .0046). The ratio of pro-inflammatory IL-10 to anti-inflammatory TNF-α increased 27.29% in the AG and decreased 26.79% in the CG and 18.56% in the PG groups. Differences between AG and CG and AG and PG were significant (AG compared to CG, P = .0009; AG compared to PG, P = .0054). Other percentage changes in cytokine and growth factor concentration were not statistically significant between groups. In the AG, the decrease of TNF-α and IL-1β concentrations correlated positively with the decrease of PI size (P <.05).
CONCLUSION
Anodal HVMPC elevates IL-10/TNF-α in blood serum. The decrease of TNF-α and IL-1β concentrations in blood serum correlates with a decrease of PI wound area. More research is needed to determine whether the changes induced by anodal HVMPC improve PI healing and to determine whether and how different electrical currents affect the activity of biological agents responsible for specific wound healing phases, both within wounds and in patients' blood. In clinical practice, anodal HVMPC should be used to increase the ratio of anti-inflammatory IL-10 to pro-inflammatory TNF-α , which may promote healing.",2019,The decrease of TNF-α and IL-1β concentrations in blood serum correlates with a decrease of PI wound area.,"[""All patients with neurological injuries (spinal cord injury, ischemic stroke, and blunt trauma to the head) and a stage 2, stage 3, or stage 4 PI of at least 4 weeks' duration hospitalized in one rehabilitation center were eligible to participate if older than 18 years of age and willing to consent to donating blood samples"", '43 participants, 15 were randomized to AG (mean age 53.87 ± 13.30 years), 13 to CG (mean age 51.08 ± 20.43 years), and 15 to PG treatment (mean age 51.20 ± 14.47 years', 'Exclusion criteria included local contraindications to electrical stimulation (cancer, electronic implants, osteomyelitis, tunneling, necrotic wounds), PIs requiring surgical intervention, patients with poorly controlled diabetes mellitus (HbA1C > 7%), critical wound infection, and/or allergies to standard wound treatment', 'Patients With Neurological Injuries', 'patients with neurological injuries']","['Anodal HVMPC elevates IL-10/TNF-α', 'anodal and cathodal high-voltage monophasic pulsed currents (HVMPC', 'anodal (AG) or cathodal (CG) HVMPC treatment', 'placebo', 'Anodal and Cathodal High-voltage Electrical Stimulation', 'HVMPC']","['concentration of IL-10', 'ratio of pro-inflammatory IL-10 to anti-inflammatory TNF-α', 'AG and CG and AG and PG', 'blood level of cytokines (interleukin [IL]-1β, IL-10, and tumor necrosis factor [TNF]-α) and growth factors (insulin-like growth factor [IGF]-1 and transforming growth factor [TGF]-β1', 'cytokine and growth factor concentration', 'PI size', 'PI healing', 'TNF-α and IL-1β concentrations', 'TNF-α, IL-1β, IL-10, TGF-β1, and IGF-1 levels in blood serum']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751792', 'cui_str': 'Injuries, Nervous System'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1272654', 'cui_str': 'Wound care management'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205186', 'cui_str': 'Monophasic (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",43.0,0.0556076,The decrease of TNF-α and IL-1β concentrations in blood serum correlates with a decrease of PI wound area.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Polak', 'Affiliation': 'Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Luther C', 'Initials': 'LC', 'LastName': 'Kloth', 'Affiliation': 'Marquette University, Milwaukee, WI.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Paczula', 'Affiliation': 'Rehabilitation Center ""Repty,"" Tarnowskie Gory, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Nawrat-Szoltysik', 'Affiliation': 'Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kucio', 'Affiliation': 'Multispecialty Hospital, Siemianowice Slaskie, Poland.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Manasar', 'Affiliation': 'Silesian Medical Laboratories, Katowice, Poland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Blaszczak', 'Affiliation': 'Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Janikowska', 'Affiliation': 'Medical University of Silesia, Poland.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Mazurek', 'Affiliation': 'Medical University of Silesia, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Malecki', 'Affiliation': 'Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kucio', 'Affiliation': 'Academy of Physical Education, Katowice, Poland.'}]",Wound management & prevention,[]
1432,30819527,Re: Bladder Preservation with Twice-a-day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine for Muscle-invasive Bladder Cancer: NRG/RTOG 0712-A Randomized Phase II Trial.,,2019,,['Muscle-invasive Bladder Cancer'],['Re: Bladder Preservation with Twice-a-day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine'],[],"[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]","[{'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]",[],,0.0405648,,"[{'ForeName': 'J Alfred', 'Initials': 'JA', 'LastName': 'Witjes', 'Affiliation': 'Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: fred.witjes@radboudumc.nl.'}]",European urology,['10.1016/j.eururo.2019.02.020']
1433,30825082,Competitive Employment for Transition-Aged Youth with Significant Impact from Autism: A Multi-site Randomized Clinical Trial.,"This study reports the results of a multi-site, parallel block randomized clinical trial to expand the previous findings regarding the implementation of Project SEARCH plus ASD Supports (PS + ASD) on employment outcomes upon graduation from high school. Participants were 156 individuals with significant impact from ASD between the ages of 18-21. There was a significant difference between treatment and control groups with 73.4% of the treatment group acquiring competitive employment at or above minimum wage by 1-year after graduation compared to 17% of the control group for whom data was provided. At 1-year, employed treatment group participants worked an average of 21.2 h per week (SD = 9) for a mean hourly wage of $9.61 per hour (SD = $1.55).Clinical Trial Registration: clinicaltrials.gov Identifier: NCT03560453.",2020,There was a significant difference between treatment and control groups with 73.4% of the treatment group acquiring competitive employment at or above minimum wage by 1-year after graduation compared to 17% of the control group for whom data was provided.,"['Participants were 156 individuals with significant impact from ASD between the ages of 18-21', 'Transition-Aged Youth with Significant Impact from Autism']","['Project SEARCH plus ASD Supports (PS\u2009+\u2009ASD', 'Competitive Employment']",['competitive employment'],"[{'cui': 'C2933137', 'cui_str': 'AM 156'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}]",156.0,0.231092,There was a significant difference between treatment and control groups with 73.4% of the treatment group acquiring competitive employment at or above minimum wage by 1-year after graduation compared to 17% of the control group for whom data was provided.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wehman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Schall', 'Affiliation': 'Rehabilitation Research and Training Center, Virginia Commonwealth University, Richmond, VA, USA. cmschall@vcu.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDonough', 'Affiliation': 'Rehabilitation Research and Training Center, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Brooke', 'Affiliation': 'Rehabilitation Research and Training Center, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Ham', 'Affiliation': 'Rehabilitation Research and Training Center, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Whittenburg', 'Affiliation': 'Rehabilitation Research and Training Center, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Brooke', 'Affiliation': 'Rehabilitation Research and Training Center, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Avellone', 'Affiliation': 'Rehabilitation Research and Training Center, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Riehle', 'Affiliation': ""Division of Disability Services, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03940-2']
1434,30825083,Brief Report: Effectiveness of an Accelerated Version of the PEERS® Social Skills Intervention for Adolescents.,"Evidence supporting the effectiveness of the PEERS® social skills intervention for adolescents with autism spectrum disorder is relatively strong. Less is known about whether the duration of the program impacts participant outcomes. The current study compared outcomes of participants randomly assigned to participate in an accelerated version of PEERS that met twice weekly for 7 weeks (n = 11) or the traditional PEERS program that met once weekly for 14 weeks (n = 10). The accelerated PEERS group demonstrated improvements consistent with previous research on the program, and treatment response did not differ significantly between the accelerated PEERS and traditional PEERS groups. Together, findings provide preliminary evidence that PEERS is effective when administered as a 7-week program.",2020,"The accelerated PEERS group demonstrated improvements consistent with previous research on the program, and treatment response did not differ significantly between the accelerated PEERS and traditional PEERS groups.","['adolescents with autism spectrum disorder', 'Adolescents']","['PEERS® social skills intervention', 'PEERS® Social Skills Intervention', 'traditional PEERS program']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0361825,"The accelerated PEERS group demonstrated improvements consistent with previous research on the program, and treatment response did not differ significantly between the accelerated PEERS and traditional PEERS groups.","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Matthews', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA. nmatthews@autismcenter.org.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Laflin', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Beatriz C', 'Initials': 'BC', 'LastName': 'Orr', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Warriner', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'DeCarlo', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Smith', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03939-9']
1435,30729333,The effect of vitamin D and E vaginal suppositories on tamoxifen-induced vaginal atrophy in women with breast cancer.,"PURPOSE
Vaginal atrophy is one of the most common side effects of using tamoxifen in women with breast cancer. Hormone therapy for vaginal atrophy is prohibited in these women. The present study was conducted to investigate the effect of vitamin D and E vaginal suppositories on vaginal atrophy in women with breast cancer receiving tamoxifen.
METHODS
Women under breast cancer management receiving tamoxifen and showing symptoms of vaginal atrophy were randomized triple-blind to an 8-week trial on vaginal suppository vitamin E or vitamin D or placebo administered every night before bedtime. The genitourinary atrophy self-assessment tool was administered, and pH was measured in all three groups before the intervention and at the end of weeks 2, 4, and 8 of the intervention. The Vaginal Maturation Index (VMI) was also measured before the intervention and at the end of the eighth week. Data were analyzed with paired t tests, repeated measures analysis of variance, and chi-square test.
RESULTS
Thirty-two patients were randomized in each group. The results obtained showed an increase in the VMI by the end of the eighth week of the intervention in the groups receiving the vitamin D and E vaginal suppositories compared with the placebo group (P < 0.001). The vaginal pH also reduced in both groups compared with that in the placebo group (P < 0.001). The symptoms of self-reported genitourinary atrophy also improved in the two intervention groups compared with those in the placebo group by the end of the eighth week (P < 0.001).
CONCLUSION
These data support that vitamin D and E vaginal suppositories were beneficial in improving vaginal atrophy in women with breast cancer receiving tamoxifen. Given the prohibition on hormone therapy in these women, the suppositories can be used as an alternative therapy to improve these symptoms.",2019,The vaginal pH also reduced in both groups compared with that in the placebo group (P < 0.001).,"['Women under breast cancer management receiving tamoxifen and showing symptoms of vaginal atrophy', 'women with breast cancer receiving tamoxifen', 'women with breast cancer', 'women with breast cancer receiving', 'Thirty-two patients']","['vaginal suppository vitamin E or vitamin D or placebo', 'placebo', 'vitamin D and E vaginal suppositories', 'Hormone therapy', 'tamoxifen']","['vaginal pH', 'Vaginal Maturation Index (VMI', 'VMI', 'vaginal atrophy', 'symptoms of self-reported genitourinary atrophy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1136199', 'cui_str': 'Vaginal Suppository'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0429263', 'cui_str': 'Vaginal pH (observable entity)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",32.0,0.0905397,The vaginal pH also reduced in both groups compared with that in the placebo group (P < 0.001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Keshavarzi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Roksana', 'Initials': 'R', 'LastName': 'Janghorban', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences, Nemazee Square, Zand Blv., Shiraz, 7193613119, Iran. Janghorban@sums.ac.ir.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Alipour', 'Affiliation': 'Department of Pharmaceutical Quality Control, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Tahmasebi', 'Affiliation': 'Department of Surgery, School of Medicine, Breast Diseases Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Jokar', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04684-6']
1436,30880176,"Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial.","BACKGROUND
Patients with short bowel syndrome might have impaired postprandial endogenous glucagon-like peptide-2 (GLP-2) secretion, which is required for optimal intestinal adaptation. We aimed to assess the therapeutic potential of glepaglutide, a novel long-acting GLP-2 analogue, for reducing faecal output and increasing intestinal absorption in patients with short bowel syndrome.
METHODS
In this single-centre, double-blind, crossover, randomised phase 2 trial, adults (aged ≥18 to ≤90 years) with short bowel syndrome and with a faecal wet weight output of 1500 g/day or more were randomly assigned to receive one of six dose sequences of glepaglutide (10 mg, 1 mg; 10 mg, 0·1 mg; 1 mg, 10 mg; 1 mg, 0·1 mg; 0·1 mg, 10 mg; or 0·1 mg, 1 mg). Patients received daily subcutaneous injections of the first assigned dose of glepaglutide for 3 weeks, followed by a washout period of 4-8 weeks, and then the second dose of glepaglutide for 3 weeks. An unmasked statistician generated the randomisation list, and the trial investigator enrolled patients and assigned them their patient numbers. Trial investigators, patients, and other care providers were masked throughout the trial. The primary endpoint was the absolute change from baseline in faecal wet weight output, measured separately over the two treatment periods. Metabolic balance studies were done before and after each treatment period to assess the primary endpoint. Per-protocol analysis was used to assess the efficacy. Safety analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT02690025, and has completed.
FINDINGS
Of the 22 patients screened between Feb 5, 2016, and Jan 25, 2017, 18 patients were randomly assigned and treated with glepaglutide; 16 patients completed the trial. Treatment with 1 mg and 10 mg glepaglutide changed the adjusted mean faecal output by -592 g/day (95% CI -913 to -272; p=0·002) and -833 g/day (-1152 to -515; p=0·0002) from baseline, respectively. No changes were observed with 0·1 mg glepaglutide. Of the 18 patients who were randomly assigned to treatment, common treatment-related adverse events were stoma complications (13 [72%] patients), injection site reactions (11 [61%]), peripheral oedema (ten [56%]), nausea and abdominal pain (eight [44%] each), polyuria and fatigue (six [33%] each), abdominal distention, vomiting, and dizziness (five [28%] each); and cough and decreased appetite (four [22%] each). Related or possibly related serious adverse events were reported in two patients in the 0·1 mg dose group and two patients in the 10 mg dose group. These events included abdominal pain, stoma obstruction, catheter-related sepsis, and infection of unknown origin. No patients died during the trial.
INTERPRETATION
Glepaglutide was well tolerated, and was associated with improved intestinal absorption in patients with short bowel syndrome with 1 mg and 10 mg glepaglutide, but not with 0·1 mg glepaglutide. Larger phase 3 clinical trials of longer durations have been initiated to fully assess the safety and efficacy of glepaglutide.
FUNDING
Zealand Pharma.",2019,Related or possibly related serious adverse events were reported in two patients in the 0·1 mg dose group and two patients in the 10 mg dose group.,"['Patients with short bowel syndrome', 'adults (aged ≥18 to ≤90 years) with short bowel syndrome and with a faecal wet weight output of 1500 g/day or more', '18 patients', '22 patients screened between Feb 5, 2016, and Jan 25, 2017, 18 patients', 'patients with short bowel syndrome', '16 patients completed the trial']","['glepaglutide', 'Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue']","['polyuria and fatigue', 'cough and decreased appetite', 'abdominal pain, stoma obstruction, catheter-related sepsis, and infection of unknown origin', 'nausea and abdominal pain', 'injection site reactions', 'adjusted mean faecal output', 'absolute change from baseline in faecal wet weight output', 'abdominal distention, vomiting, and dizziness', 'peripheral oedema', 'intestinal absorption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0912332', 'cui_str': 'Proglucagon (126-158)'}]","[{'cui': 'C0032617', 'cui_str': 'Polyuria'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C3805041', 'cui_str': 'Stoma obstruction'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0021826', 'cui_str': 'Intestinal Absorption'}]",18.0,0.381207,Related or possibly related serious adverse events were reported in two patients in the 0·1 mg dose group and two patients in the 10 mg dose group.,"[{'ForeName': 'Rahim M', 'Initials': 'RM', 'LastName': 'Naimi', 'Affiliation': 'Department of Medical Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark. Electronic address: rahim.mohammad.naimi@regionh.dk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hvistendahl', 'Affiliation': 'Department of Medical Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lotte H', 'Initials': 'LH', 'LastName': 'Enevoldsen', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine, and PET, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'Madsen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fuglsang', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Steen S', 'Initials': 'SS', 'LastName': 'Poulsen', 'Affiliation': 'Department of Biomedical Sciences, The Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hannelouise', 'Initials': 'H', 'LastName': 'Kissow', 'Affiliation': 'Novo Nordisk Foundation Centre of Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Pedersen', 'Affiliation': 'Novo Nordisk Foundation Centre of Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Nerup', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Ambrus', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Achiam', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars B', 'Initials': 'LB', 'LastName': 'Svendsen', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Centre of Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Novo Nordisk Foundation Centre of Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Svend H', 'Initials': 'SH', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Steensberg', 'Affiliation': 'Research and Development, Zealand Pharma, Glostrup, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Mouritzen', 'Affiliation': 'Research and Development, Zealand Pharma, Glostrup, Denmark.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Hansen', 'Affiliation': 'Research and Development, Zealand Pharma, Glostrup, Denmark.'}, {'ForeName': 'Palle B', 'Initials': 'PB', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Medical Gastroenterology and Hepatology, Rigshospitalet, Copenhagen, Denmark.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30077-9']
1437,30878103,"Safety and efficacy of sonothrombolysis for acute ischaemic stroke: a multicentre, double-blind, phase 3, randomised controlled trial.","BACKGROUND
Pulsed-wave ultrasound increases the exposure of an intracranial thrombus to alteplase (recombinant tissue plasminogen activator), potentially facilitating early reperfusion. We aimed to ascertain if a novel operator-independent transcranial ultrasound device delivering low-power high-frequency ultrasound could improve functional outcome in patients treated with alteplase after acute ischaemic stroke.
METHODS
We did a multicentre, double-blind, phase 3, randomised controlled trial (CLOTBUST-ER) at 76 medical centres in 14 countries. We included patients with acute ischaemic stroke (National Institutes of Health Stroke Scale score ≥10) who received intravenous thrombolysis (alteplase bolus) within 3 h of symptom onset in North America and within 4·5 h of symptom onset in all other countries. Participants were randomly allocated (1:1) via an interactive web response system to either active ultrasound (2 MHz pulsed-wave ultrasound for 120 min [sonothrombolysis]; intervention group) or sham ultrasound (control group). Ultrasound was delivered using an operator-independent device, which had to be activated within 30 min of the alteplase bolus. Participants, investigators, and those assessing outcomes were unaware of group assignments. The primary outcome was improvement in the modified Rankin Scale score at 90 days in patients enrolled within 3 h of symptom onset, assessed in the intention-to-treat population as a common odds ratio (cOR) using ordinal logistic regression shift analysis. This trial is registered with ClinicalTrials.gov, number NCT01098981. The trial was stopped early by the funder after the second interim analysis because of futility.
FINDINGS
Between August, 2013, and April, 2015, 335 patients were randomly allocated to the intervention group and 341 patients to the control group. Compared with the control group, the adjusted cOR for an improvement in modified Rankin Scale score at 90 days in the intervention group was 1·05 (95% CI 0·77-1·45; p=0·74). 51 (16%) of 317 patients in the intervention group and 44 (13%) of 329 patients in the control group died (unadjusted OR 1·24, 95% CI 0·80-1·92; p=0·37) and 83 (26%) and 79 (24%), respectively, had serious adverse events (1·12, 0·79-1·60; p=0·53).
INTERPRETATION
Sonothrombolysis delivered by an operator-independent device to patients treated with alteplase after acute ischaemic stroke was feasible and most likely safe, but no clinical benefit was seen at 90 days. Sonothrombolysis could be further investigated either in randomised trials undertaken in stroke centres that are dependent on patient transfer for endovascular reperfusion therapies or in countries where these treatments cannot yet be offered as the standard of care.
FUNDING
Cerevast Therapeutics.",2019,"Compared with the control group, the adjusted cOR for an improvement in modified Rankin Scale score at 90 days in the intervention group was 1·05 (95% CI 0·77-1·45; p=0·74).","['patients treated with alteplase after acute ischaemic stroke', 'patients with acute ischaemic stroke (National Institutes of Health Stroke Scale score ≥10) who received intravenous thrombolysis (alteplase bolus) within 3 h of symptom onset in North America and within 4·5 h of symptom onset in all other countries', 'acute ischaemic stroke', '76 medical centres in 14 countries', 'Between August, 2013, and April, 2015', '335 patients were randomly allocated to the intervention group and 341 patients to the control group']","['transcranial ultrasound device delivering low-power high-frequency ultrasound', 'sonothrombolysis', 'interactive web response system to either active ultrasound (2 MHz pulsed-wave ultrasound for 120 min [sonothrombolysis]; intervention group) or sham ultrasound (control group']","['cOR', 'modified Rankin Scale score', 'functional outcome', 'serious adverse events', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",335.0,0.513388,"Compared with the control group, the adjusted cOR for an improvement in modified Rankin Scale score at 90 days in the intervention group was 1·05 (95% CI 0·77-1·45; p=0·74).","[{'ForeName': 'Andrei V', 'Initials': 'AV', 'LastName': 'Alexandrov', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center, Memphis, TN, USA. Electronic address: avalexandrov@att.net.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Köhrmann', 'Affiliation': 'Department of Neurology, Universitätsklinikum Erlangen, Erlangen, Germany; Department of Neurology, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Soinne', 'Affiliation': 'Department of Neurology, Helsinki University Hospital and Clinical Neurosciences, Neurology, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsivgoulis', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center, Memphis, TN, USA; Second Department of Neurology, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; International Clinical Research Center and Department of Neurology, St Anne\'s University Hospital in Brno, Brno, Czech Republic.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Barreto', 'Affiliation': 'Department of Neurology, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore and Division of Neurology, Department of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulik', 'Affiliation': ""International Clinical Research Center and Department of Neurology, St Anne's University Hospital in Brno, Brno, Czech Republic; Medical Faculty, Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Brandt', 'Affiliation': 'Cerevast Therapeutics, Redmond, WA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Alleman', 'Affiliation': 'Cerevast Therapeutics, Redmond, WA, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Grotta', 'Affiliation': 'Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Saqqur', 'Affiliation': 'Department of Medicine (Neurology), University of Alberta, Edmonton, AB, Canada; Neuroscience Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Mavridis', 'Affiliation': 'Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece; Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Psaltopoulou', 'Affiliation': 'Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Vosko', 'Affiliation': 'Department of Neurology, Kepler University Clinic, General Hospital Linz (AKH), Linz, Austria.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Center for Stroke Research Berlin, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Pitchaiah', 'Initials': 'P', 'LastName': 'Mandava', 'Affiliation': 'Stroke Outcomes Laboratory, Department of Neurology, Baylor College of Medicine, Houston, TX, USA; Michael E DeBakey VA Medical Center Stroke Program and Center for Translational Research on Inflammatory Diseases, Houston, TX, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Kent', 'Affiliation': 'Stroke Outcomes Laboratory, Department of Neurology, Baylor College of Medicine, Houston, TX, USA; Michael E DeBakey VA Medical Center Stroke Program and Center for Translational Research on Inflammatory Diseases, Houston, TX, USA.'}, {'ForeName': 'Anne W', 'Initials': 'AW', 'LastName': 'Alexandrov', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center, Memphis, TN, USA; Australian Catholic University, Sydney, NSW, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Schellinger', 'Affiliation': 'Departments of Neurology and Neurogeriatry, John Wesling Medical Center Minden, Ruhr University Bochum, Minden, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30026-2']
1438,30876946,Monotherapy with tenofovir disoproxil fumarate for adefovir-resistant vs. entecavir-resistant chronic hepatitis B: A 5-year clinical trial.,"BACKGROUND & AIMS
Tenofovir disoproxil fumarate (TDF) monotherapy has displayed non-inferior efficacy to TDF plus entecavir (ETV) combination therapy in patients with hepatitis B virus (HBV) resistant to ETV and/or adefovir (ADV). Nonetheless, the virologic response rate was suboptimal in patients receiving up to 144 weeks of TDF monotherapy. We aimed to assess the efficacy and safety of TDF monotherapy given for up to 240 weeks.
METHODS
One trial enrolled patients with ETV resistance without ADV resistance (n = 90), and another trial included patients with ADV resistance (n = 102). Most patients (91.2%) also had lamivudine resistance. Patients were randomized 1:1 to receive TDF monotherapy or TDF + ETV combination therapy for 48 weeks, and then TDF monotherapy until week 240. We compared efficacy between the studies and safety in the pooled population at 240 weeks.
RESULTS
At week 240, the proportion of patients with serum HBV DNA <15 IU/ml was not significantly different between the ETV and ADV resistance groups in the full analysis set (84.4% vs. 73.5%; p = 0.07), which was significantly different by on-treatment analysis (92.7% vs. 79.8%; p = 0.02). Virologic blips associated with poor medication adherence occurred in 7 patients throughout the 240 weeks. None developed additional HBV resistance mutations. Among the 170 HBV e antigen (HBeAg)-positive patients at baseline, 12 (7.1%) achieved HBeAg seroconversion at week 240. None achieved HBV surface antigen seroclearance. Significant decreases from baseline were observed at week 240 in the estimated glomerular filtration rate (-3.21 ml/min/1.73 m 2 by the CKD-EPI equation, p <0.001) and bone mineral density (g/cm 2 ) at the femur (-2.48%, p <0.001).
CONCLUSIONS
Up to 240 weeks of TDF monotherapy provided an increasing virologic response rate in heavily pretreated patients with HBV resistant to ETV and/or ADV. However, it was associated with poor serological responses and decreasing renal function and bone mineral density. (ClinicalTrials.gov No, NCT01639066 and NCT01639092).
LAY SUMMARY
In patients chronically infected with hepatitis B virus resistant to multiple drugs including lamivudine, entecavir, and/or adefovir, tenofovir disoproxil fumarate (TDF) monotherapy showed non-inferior efficacy compared with the combination therapy of TDF plus entecavir. Nonetheless, short-term TDF monotherapy was associated with suboptimal virologic response, and its long-term safety was uncertain. This study displayed that 240 weeks of TDF monotherapy provided a virologic response in most of those patients, but it was associated with poor serological responses and decreasing renal function and bone mineral density.",2019,"CONCLUSIONS
Up to 240 weeks of TDF monotherapy provided an increasing virologic response rate in heavily pretreated patients with HBV resistant to ETV and/or ADV.","['patients chronically infected with hepatitis B virus resistant to multiple drugs including', 'adefovir-resistant vs. entecavir-resistant chronic hepatitis B', 'One trial enrolled patients with ETV resistance without ADV resistance (n\u202f=\u202f90), and another trial included patients with ADV resistance (n\u202f=\u202f102', 'patients with hepatitis B virus (HBV) resistant to ETV and/or adefovir (ADV']","['Monotherapy with tenofovir disoproxil fumarate', 'Tenofovir disoproxil fumarate (TDF) monotherapy', 'lamivudine, entecavir, and/or adefovir, tenofovir disoproxil fumarate (TDF) monotherapy', 'TDF plus entecavir', 'TDF monotherapy', 'TDF plus entecavir (ETV) combination therapy', 'TDF monotherapy or TDF\u202f+\u202fETV combination therapy']","['bone mineral density', 'HBeAg seroconversion', 'medication adherence', 'additional HBV resistance mutations', 'glomerular filtration rate', 'renal function and bone mineral density', 'suboptimal virologic response', 'virologic response rate', 'efficacy and safety', 'lamivudine resistance', 'virologic response', 'HBV surface antigen seroclearance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0050175', 'cui_str': 'adefovir'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0050175', 'cui_str': 'adefovir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0003339', 'cui_str': 'Surface Markers, Immunological'}]",,0.0886791,"CONCLUSIONS
Up to 240 weeks of TDF monotherapy provided an increasing virologic response rate in heavily pretreated patients with HBV resistant to ETV and/or ADV.","[{'ForeName': 'Young-Suk', 'Initials': 'YS', 'LastName': 'Lim', 'Affiliation': 'Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: limys@amc.seoul.kr.'}, {'ForeName': 'Geum-Youn', 'Initials': 'GY', 'LastName': 'Gwak', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jonggi', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yung Sang', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kwan Soo', 'Initials': 'KS', 'LastName': 'Byun', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Byung Chul', 'Initials': 'BC', 'LastName': 'Yoo', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Han Chu', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: hch@amc.seoul.kr.'}]",Journal of hepatology,['10.1016/j.jhep.2019.02.021']
1439,30871958,Effect of weight-bearing wrist movement with carpal-stabilizing taping on pain and range of motion in subjects with dorsal wrist pain: A randomized controlled trial.,"STUDY DESIGN
Randomized control trial.
INTRODUCTION
During weight-bearing wrist movement, potential stabilizing forces caused by carpal stabilizing taping (CST) may restrict movement of the carpal bones, allowing greater wrist joint extension.
PURPOSE OF THE STUDY
The purpose of study was to investigate the effect of CST during weight-bearing wrist movement on pain intensity and range of motion (ROM) of wrist extension in subjects with dorsal wrist pain.
METHODS
Thirty participants with dorsal wrist pain when weight bearing through the hand were randomly allocated into 2 groups: (1) a CST group using rigid tape and (2) placebo taping (PT) group using elastic tape. Subjects performed weight-bearing wrist movements with CST or PT in 6 sessions for 1 week. Active and passive ROM (AROM and PROM), and the visual analog scale (VAS) were assessed at baseline and after the intervention.
RESULTS
The AROM and PROM of wrist extension increased significantly in both groups compared with preintervention values (P < .01). Comparing the PT and CST groups, the differences between preintervention and postintervention AROM (mean difference [MD] = +8.6°) and PROM (MD = +6.8°) were significantly greater in the CST group than in the PT group (P < .01). The CST group also showed greater improvement in VAS compared with the PT group (MD = -18 mm) (P < .01).
CONCLUSION
We recommend CST during weight-bearing wrist movement as an effective intervention for both increasing wrist extension ROM and decreasing pain in patients with dorsal wrist pain during weight bearing through the hand.",2020,The AROM and PROM of wrist extension increased significantly in both groups compared with preintervention values (P < .01).,"['subjects with dorsal wrist pain', 'patients with dorsal wrist pain during weight bearing through the hand', 'Thirty participants with dorsal wrist pain when weight bearing through the hand']","['CST', 'carpal stabilizing taping (CST', 'CST or PT', 'CST group using rigid tape and (2) placebo taping (PT) group using elastic tape', 'weight-bearing wrist movement with carpal-stabilizing taping']","['pain intensity and range of motion (ROM) of wrist extension', 'preintervention and postintervention AROM', 'AROM and PROM of wrist extension', 'PROM', 'Active and passive ROM (AROM and PROM), and the visual analog scale (VAS', 'VAS', 'pain and range of motion']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0221785', 'cui_str': 'Wrist joint pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0586489,The AROM and PROM of wrist extension increased significantly in both groups compared with preintervention values (P < .01).,"[{'ForeName': 'Geun-Su', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of KEMA Therapy, Graduate School of Humanities Industry, Joongbu University, Geumsan, Republic of Korea.'}, {'ForeName': 'Jong-Hyuck', 'Initials': 'JH', 'LastName': 'Weon', 'Affiliation': 'Department of Physical Therapy, College of Health & Welfare, Kinesiopathologic Science Institute, Joongbu University, Geumsan, Republic of Korea.'}, {'ForeName': 'Moon-Hwan', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Wonju Christian Hospital, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Koh', 'Affiliation': 'Department of Physical Therapy, Masan University, Changwon, Republic of Korea.'}, {'ForeName': 'Do-Young', 'Initials': 'DY', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Therapy, College of Health & Welfare, Kinesiopathologic Science Institute, Joongbu University, Geumsan, Republic of Korea. Electronic address: ptsports@joongbu.ac.kr.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.02.001']
1440,30848697,Myocardial protection and clinical outcomes in Tetralogy of Fallot patients undergoing intracardiac repair: a randomized study of two cardioplegic techniques.,"BACKGROUND
Myocardial protection in Tetralogy of Fallot patients undergoing intracardiac repair is suboptimal due to hypertrophied right ventricle. Hypertrophied myocardium is more susceptible to poor myocardial preservation because of inadequate capillary density as compared to the myocytes. There is a capillary to myocyte ratio mismatch. But del Nido Cardioplegia owing to its less viscosity is able to get more evenly distributed under hypothermic cardiopulmonary bypass as opposed to blood Cardioplegia. We hypothesized that the del Nido Cardioplegia technique, would be beneficial in myocardial protection because of its composition and method of delivery, leading into better early and late clinical outcomes in patients undergoing Tetralogy of Fallot repair as compared to blood cardioplegia reconstituted using St Thomas Cardioplegia solution. The objective of the study was to identify a better technique of myocardial preservation in Tetralogy of Fallot patient.
METHODS
In total, 56 Tetralogy of Fallot patients undergoing intracardiac repair under mild hypothermic cardiopulmonary bypass were randomly allocated to receive antegrade Cardioplegia with either standard blood Cardioplegia (Group I) or del Nido Cardioplegia (Group II). Preoperative as well as postoperative data including echocardiographic parameters for right ventricle functions, creatine kinase MB level, inotropic requirement, mechanical ventilation duration, intensive care unit stay and hospital mortality were evaluated.
RESULTS
Inotropic score in the first 24 hours postoperatively was significantly lower in Group II compared to Group I (13.4 ± 7.2 vs. 21.2 ± 9.6, p = 0.003). Creatine kinase MB level (ng/mL) was comparable between the groups. Echocardiographic parameters for right ventricle functions were also comparable between the groups during early as well as after 3 to 6 months postoperatively.
CONCLUSION
Del Nido Cardioplegia is equally efficacious in providing myocardial protection during intracardiac repair under mild hypothermic cardiopulmonary bypass in Tetralogy of Fallot patients as compared to blood Cardioplegia solution with the added benefit of reducing inotropic requirement in first 24 hours postoperative period.",2019,"Echocardiographic parameters for right ventricle functions were also comparable between the groups during early as well as after 3 to 6 months postoperatively.
","['patients undergoing Tetralogy of Fallot repair', '56 Tetralogy of Fallot patients undergoing intracardiac repair under mild hypothermic cardiopulmonary bypass', 'Tetralogy of Fallot patient', 'Tetralogy of Fallot patients undergoing', 'intracardiac repair under mild hypothermic cardiopulmonary bypass in Tetralogy of Fallot patients', 'Tetralogy of Fallot patients undergoing intracardiac repair']","['intracardiac repair', 'antegrade Cardioplegia with either standard blood Cardioplegia (Group I) or del Nido Cardioplegia']","['Echocardiographic parameters for right ventricle functions', 'Inotropic score', 'postoperative data including echocardiographic parameters for right ventricle functions, creatine kinase MB level, inotropic requirement, mechanical ventilation duration, intensive care unit stay and hospital mortality', 'Creatine kinase MB level (ng/mL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0397326', 'cui_str': 'Repair of tetralogy of Fallot (procedure)'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0729936', 'cui_str': 'Intracardiac (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0729936', 'cui_str': 'Intracardiac (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}, {'cui': 'C0018791', 'cui_str': 'Cardioplegia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005768'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0225883', 'cui_str': 'Right Ventricle'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]",56.0,0.0437195,"Echocardiographic parameters for right ventricle functions were also comparable between the groups during early as well as after 3 to 6 months postoperatively.
","[{'ForeName': 'Sunder Lal', 'Initials': 'SL', 'LastName': 'Negi', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Banashree', 'Initials': 'B', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Rana Sandeep', 'Initials': 'RS', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Goverdhan Dutt', 'Initials': 'GD', 'LastName': 'Puri', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Perfusion,['10.1177/0267659119828890']
1441,30839416,"Phase 2, Randomized, Dose-finding Studies of Omidenepag Isopropyl, a Selective EP2 Agonist, in Patients With Primary Open-angle Glaucoma or Ocular Hypertension.","PRéCIS:: Three randomized, multicenter studies demonstrated the stable intraocular pressure-lowering effects and tolerability of omidenepag isopropyl in patients with primary open-angle glaucoma and ocular hypertension; 0.002% was identified as the optimal dose for further investigation.
PURPOSE
The purpose of this study was to assess the safety and efficacy of omidenepag isopropyl, a selective EP2 agonist, and to determine the optimal dose for further investigation.
PATIENTS AND METHODS
Three randomized, controlled, masked, multicenter studies were conducted in United States (study 1, NCT01868126; study 2, NCT02179008) and Japan (study 3, NCT02623738). Patients were randomized to 1 of 7 omidenepag isopropyl concentrations (0.0003%, 0.001%, 0.0012%, 0.0016%, 0.002%, 0.0025%, and 0.003%), latanoprost (0.005%), or placebo, 1 drop once daily for 28 days (studies 1 and 3) or 90 days (study 2). Primary endpoints were the observed mean diurnal intraocular pressure (IOP) and IOP at each time point on the final visit (studies 1 and 2) and change from baseline in mean diurnal IOP at week 4 (study 3).
RESULTS
IOP-lowering effects of omidenepag isopropyl 0.0003% to 0.002% increased dose-dependently. Omidenepag isopropyl 0.002% and 0.0025% resulted in clinically relevant mean diurnal IOP reductions from baseline that were similar to those of latanoprost and superior to placebo (P<0.005). Maximum reductions had already been achieved by week 1, and stable IOP-lowering effects were observed at all postbaseline time points up to 3 months. Most adverse events (AEs) were mild. Conjunctival hyperemia was the most frequently reported AE, the incidence of which increased dose-dependently. The safety profiles of omidenepag isopropyl 0.002% and 0.0025% were similar, with a slightly lower incidence of AEs in the 0.002% group.
CONCLUSIONS
Omidenepag isopropyl demonstrated stable IOP-lowering effects and was well tolerated; 0.002% was identified as the optimal dose for phase 3 investigation.",2019,"CONCLUSIONS
Omidenepag isopropyl demonstrated stable IOP-lowering effects and was well tolerated; 0.002% was identified as the optimal dose for phase 3 investigation.","['Patients With Primary Open-angle Glaucoma or Ocular Hypertension', 'patients with primary open-angle glaucoma and ocular hypertension']","['omidenepag isopropyl', 'placebo', 'latanoprost', 'Omidenepag Isopropyl, a Selective EP2 Agonist', 'omidenepag isopropyl, a selective EP2 agonist']","['safety and efficacy', 'Conjunctival hyperemia', 'mean diurnal IOP reductions', 'stable IOP-lowering effects', 'mean diurnal intraocular pressure (IOP) and IOP at each time point on the final visit (studies 1 and 2) and change from baseline in mean diurnal IOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.165393,"CONCLUSIONS
Omidenepag isopropyl demonstrated stable IOP-lowering effects and was well tolerated; 0.002% was identified as the optimal dose for phase 3 investigation.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Ophthalmology, University of Tokyo, Bunkyo-ku.'}, {'ForeName': 'Fenghe', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Santen Inc., Emeryville, CA.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Kawata', 'Affiliation': 'Santen Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Iwata', 'Affiliation': 'Santen Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Santen Inc., Emeryville, CA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Odani-Kawabata', 'Affiliation': 'Santen Inc., Emeryville, CA.'}, {'ForeName': 'Naveed K', 'Initials': 'NK', 'LastName': 'Shams', 'Affiliation': 'Santen Inc., Emeryville, CA.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001221']
1442,30690785,"Effects of Denosumab and Alendronate on Bone Health and Vascular Function in Hemodialysis Patients: A Randomized, Controlled Trial.","Mineral and bone disorders including osteoporosis are common in dialysis patients and contribute to increased morbimortality. However, whether denosumab and alendronate are effective and safe treatments in hemodialysis patients is not known. Thus, we conducted a prospective, three-center study of 48 hemodialysis patients who were diagnosed as having osteoporosis and had not received anti-osteoporotic agents previously. Participants were randomized to either denosumab or intravenous alendronate, and all subjects received elemental calcium and calcitriol during the initial 2 weeks. The primary endpoint was the percent change in lumbar spine bone mineral density (LSBMD) at 12 months of treatment. The secondary endpoints included the following: change in BMD at other sites; change of serum bone turnover markers (BTM), coronary artery calcium score (CACS), ankle-brachial pressure index (ABI), brachial-ankle pulse wave velocity (baPWV), flow mediated dilation (FMD), and intima-media thickness at the carotid artery (CA-IMT); change from day 0 to day 14 in serum levels of Ca and P; time course of serum calcium (Ca), phosphorus (P), and intact parathyroid hormone (i-PTH); new fractures; and adverse events. Initial supplementation with elemental calcium and calcitriol markedly ameliorated the decrease of serum corrected calcium (cCa) levels induced by denosumab during the first 2 weeks, whereas serum cCa levels in the alendronate group were increased. Denosumab and alendronate markedly decreased serum levels of BTM and increased LSBMD at 12 months compared with baseline. However, no significant differences were found in the changes in LSBMD between the two groups. The serum cCa, P, and i-PTH levels in the two groups were maintained within the appropriate range. In contrast to the anti-osteoporotic effects, no significant differences after 12 months of treatment were found in the CACS, CA-IMT, ABI, baPWV, and FMD compared with pretreatment in both groups. Denosumab and alendronate treatment improved LSBMD, reduced BTM, and appeared to be safe in hemodialysis patients with osteoporosis. © 2019 American Society for Bone and Mineral Research.",2019,Denosumab and alendronate markedly decreased serum levels of BTM and increased LSBMD at 12 months compared with baseline.,"['Hemodialysis Patients', '48 hemodialysis patients who were diagnosed as having osteoporosis and had not received anti-osteoporotic agents previously', 'hemodialysis patients with osteoporosis', 'hemodialysis patients', '© 2019 American Society for Bone and Mineral Research']","['elemental calcium and calcitriol', 'denosumab and alendronate', 'Denosumab and Alendronate', 'denosumab or intravenous alendronate', 'Denosumab and alendronate']","['Bone Health and Vascular Function', 'serum corrected calcium (cCa) levels', 'serum cCa levels', 'CACS, CA-IMT, ABI, baPWV, and FMD', 'LSBMD, reduced BTM', 'serum cCa, P, and i-PTH levels', 'serum levels of BTM and increased LSBMD', 'percent change in lumbar spine bone mineral density (LSBMD', 'LSBMD', 'change in BMD at other sites; change of serum bone turnover markers (BTM), coronary artery calcium score (CACS), ankle-brachial pressure index (ABI), brachial-ankle pulse wave velocity (baPWV), flow mediated dilation (FMD), and intima-media thickness at the carotid artery (CA-IMT); change from day 0 to day 14 in serum levels of Ca and P; time course of serum calcium (Ca), phosphorus (P), and intact parathyroid hormone (i-PTH); new fractures; and adverse events']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C1276055', 'cui_str': 'ABPI - Ankle brachial pressure index'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",48.0,0.0219382,Denosumab and alendronate markedly decreased serum levels of BTM and increased LSBMD at 12 months compared with baseline.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Iseri', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'Nephrology Center, Makita General Hospital, Tokyo, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Mitsui', 'Affiliation': 'Hanedaoozora Dialysis Clinic, Tokyo, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Adachimotoki Jin Dialysis Clinic, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Hanedaoozora Dialysis Clinic, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Iyoda', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kakei', 'Initials': 'K', 'LastName': 'Ryu', 'Affiliation': 'Clinical Pharmacology, Pharmacology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Inaba', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Shibata', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3676']
1443,30784635,"Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial.","BACKGROUND
In 2015, an estimated 303 000 women died in pregnancy and childbirth. Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account for more than 50% of maternal deaths worldwide. There are effective treatments for these pregnancy complications, but they require early detection by measurement of vital signs and timely administration to save lives. The primary aim of this trial was to determine whether implementation of the CRADLE Vital Sign Alert and an education package into community and facility maternity care in low-resource settings could reduce a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy).
METHODS
We did a pragmatic, stepped-wedge, cluster-randomised controlled trial in ten clusters across Africa, India, and Haiti, introducing the device into routine maternity care. Each cluster contained at least one secondary or tertiary hospital and their main referral facilities. Clusters crossed over from existing routine care to the CRADLE intervention in one of nine steps at 2-monthly intervals, with CRADLE devices replacing existing equipment at the randomly allocated timepoint. A computer-generated randomly allocated sequence determined the order in which the clusters received the intervention. Because of the nature of the intervention, this trial was not masked. Data were gathered monthly, with 20 time periods of 1 month. The primary composite outcome was at least one of eclampsia, emergency hysterectomy, and maternal death. This study is registered with the ISRCTN registry, number ISRCTN41244132.
FINDINGS
Between April 1, 2016, and Nov 30, 2017, among 536 223 deliveries, the primary outcome occurred in 4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies. There was an 8% decrease in the primary outcome from 79·4 per 10 000 deliveries pre-intervention to 72·8 per 10 000 deliveries post-intervention (odds ratio [OR] 0·92, 95% CI 0·86-0·97; p=0·0056). After planned adjustments for variation in event rates between and within clusters over time, the unexpected degree of variability meant we were unable to judge the benefit or harms of the intervention (OR 1·22, 95% CI 0·73-2·06; p=0·45).
INTERPRETATION
There was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability. We encountered unanticipated methodological challenges with this trial design, which can provide valuable learning for future research and inform the trial design of future international stepped-wedge trials.
FUNDING
Newton Fund Global Research Programme: UK Medical Research Council; Department of Biotechnology, Ministry of Science & Technology, Government of India; and UK Department of International Development.",2019,"There was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability.","['Between April 1, 2016, and Nov 30, 2017, among 536\u2008223 deliveries', 'low-resource settings', 'In 2015, an estimated 303\u2008000', 'women died in pregnancy and childbirth', '4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies']",['novel vital sign device'],"['maternal mortality and morbidity', 'least one of eclampsia, emergency hysterectomy, and maternal death', 'Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account']","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0518766'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",536223.0,0.375814,"There was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK. Electronic address: nicola.vousden@kcl.ac.uk.""}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lawley', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Muchabayiwa Francis', 'Initials': 'MF', 'LastName': 'Gidiri', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Shivaprasad', 'Initials': 'S', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(18)30526-6']
1444,30784636,The effect of the Alive & Thrive initiative on exclusive breastfeeding in rural Burkina Faso: a repeated cross-sectional cluster randomised controlled trial.,"BACKGROUND
The benefits of exclusive breastfeeding on mortality, health, and development of children have been well documented. In Burkina Faso, the Alive & Thrive initiative combined interpersonal communication and community mobilisation activities with the aim of improving knowledge, beliefs, skills, and, ultimately, breastfeeding outcomes. The objective of this study was to determine the effect of the Alive & Thrive initiative on exclusive breastfeeding in Boucle du Mouhoun, Burkina Faso.
METHODS
We did a cluster-randomised trial with data collected with two independent, population-representative, cross-sectional surveys: a baseline survey done before the start of the initiative implementation and an endline survey done 2 years later. Rural villages in Boucle du Mouhoun, Burkina Faso, were randomly allocated by use of computer generated pseudo-random numbers, and women were eligible for participation if they had a livebirth in the 12 months preceding the survey and resided in a village selected for the study. The primary outcome was exclusive breastfeeding among infants younger than 6 months. Masking was not possible for the intervention implementation. All women who participated in the trial were included in the analysis population. The trial is registered with ClinicalTrials.gov, number NCT02435524.
FINDINGS
Between June 2 and July 28, 2015, 2288 mothers participated in the baseline survey and between June 12 and July 25, 2017, 2253 mothers participated in the endline survey. At endline, there was a risk difference of 38·9% (95% CI 32·2-45·6, p<0·001) between the reported prevalence of exclusive breastfeeding in the intervention group and that of the control group.
INTERPRETATION
A multidimensional intervention deliverable at scale in a low-income setting resulted in substantial increases in mothers' optimal breastfeeding knowledge and beliefs and in reported exclusive breastfeeding practices. However, it is possible that the findings might have been influenced by social desirability bias.
FUNDING
Bill & Melinda Gates Foundation, London School of Hygiene & Tropical Medicine.",2019,"At endline, there was a risk difference of 38·9% (95% CI 32·2-45·6, p<0·001) between the reported prevalence of exclusive breastfeeding in the intervention group and that of the control group.
","['Rural villages in Boucle du Mouhoun, Burkina Faso, were randomly allocated by use of computer generated pseudo-random numbers, and women were eligible for participation if they had a livebirth in the 12 months preceding the survey and resided in a village selected for the study', 'Between June 2 and July 28, 2015, 2288 mothers participated in the baseline survey and between June 12 and July 25, 2017, 2253 mothers participated in the endline survey', 'rural Burkina Faso', 'All women who participated in the trial were included in the analysis population']",[],['exclusive breastfeeding'],"[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]",2288.0,0.121856,"At endline, there was a risk difference of 38·9% (95% CI 32·2-45·6, p<0·001) between the reported prevalence of exclusive breastfeeding in the intervention group and that of the control group.
","[{'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Cresswell', 'Affiliation': 'MARCH Centre for Maternal, Adolescent, Reproductive & Child Health, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: jenny.cresswell@lshtm.ac.uk.'}, {'ForeName': 'Rasmané', 'Initials': 'R', 'LastName': 'Ganaba', 'Affiliation': 'AFRICSanté, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Sarrassat', 'Affiliation': 'MARCH Centre for Maternal, Adolescent, Reproductive & Child Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Somé', 'Affiliation': 'AFRICSanté, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Abdoulaye Hama', 'Initials': 'AH', 'LastName': 'Diallo', 'Affiliation': 'Centre MURAZ, Bobo-Dioulasso, Burkina Faso; Université Ouaga I Pr Joseph Ki-Zerbo, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cousens', 'Affiliation': 'MARCH Centre for Maternal, Adolescent, Reproductive & Child Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Filippi', 'Affiliation': 'MARCH Centre for Maternal, Adolescent, Reproductive & Child Health, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30494-7']
1445,30772298,A Group Randomized Intervention Trial Increases Participation in the School Breakfast Program in 16 Rural High Schools in Minnesota.,"BACKGROUND
Breakfast consumption is associated with better diet quality and healthier weights, yet many adolescents miss breakfast. Nationally, 17.1% of students participate in the School Breakfast Program (SBP). Only 10% of high school students participate.
OBJECTIVE
Our aim was to evaluate an environmental intervention to increase SBP participation in high schools.
DESIGN
A group randomized trial was carried out from 2012 to 2015.
PARTICIPANTS/SETTING
Ninth- and 10th-grade students enrolled in 16 rural schools in Minnesota (median 387 students) were randomized to intervention or control condition.
INTERVENTION
A school-based intervention that included two key components was implemented over a 12-month period. One component focused on increasing SBP participation by increasing student access to school breakfast through changes in school breakfast service practices (eg, serving breakfast from a grab-n-go cart in the atrium; expanding breakfast service times). The other component focused on promoting school breakfast through student-directed marketing campaigns.
MAIN OUTCOME MEASURE
Change in school-level participation in the SBP was assessed between baseline (among ninth and tenth graders) and follow-up (among tenth and eleventh graders). School meal and attendance records were used to assess change in school-level participation rates in the SBP.
STATISTICAL ANALYSES
The Wilcoxon test was used for analysis of difference in change in mean SBP participation rate by experimental group.
RESULTS
The median change in SBP participation rate between baseline and follow-up was 3% (interquartile range=13.5%) among the eight schools in the intervention group and 0.5% (interquartile range=0.7%) among the eight schools in the control group. This difference in change between groups was statistically significant (Wilcoxon test, P=0.03). The intervention effect increased throughout the intervention period, with change in mean SBP participation rate by the end of the school year reaching 10.3% (95% CI 3.0 to 17.6). However, among the intervention schools, the change in mean SBP participation rates was highly variable (range=-0.8% to 24.8%).
CONCLUSIONS
Interventions designed to improve access to the SBP by reducing environmental and social barriers have potential to increase participation among high school students.",2019,"The intervention effect increased throughout the intervention period, with change in mean SBP participation rate by the end of the school year reaching 10.3% (95% CI 3.0 to 17.6).","['16 rural schools in Minnesota (median 387 students', 'Nationally, 17.1% of students participate in the School Breakfast Program (SBP', '2012 to\xa02015', 'Ninth- and 10th-grade students', '16 Rural High Schools in Minnesota']","['environmental intervention', 'intervention or control condition', 'School Breakfast Program']","['mean SBP participation rates', 'median change in SBP participation rate', 'SBP participation', 'mean SBP participation rate', 'Change in school-level participation in the SBP']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205443', 'cui_str': 'Ninth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0026118', 'cui_str': 'Situational Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0201604,"The intervention effect increased throughout the intervention period, with change in mean SBP participation rate by the end of the school year reaching 10.3% (95% CI 3.0 to 17.6).","[{'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Nanney', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leduc', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hearst', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shanafelt', 'Affiliation': ''}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': ''}, {'ForeName': 'Katherine Y', 'Initials': 'KY', 'LastName': 'Grannon', 'Affiliation': ''}, {'ForeName': 'Martha Y', 'Initials': 'MY', 'LastName': 'Kubik', 'Affiliation': ''}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Caspi', 'Affiliation': ''}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Harnack', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2018.12.007']
1446,29941389,Antimicrobial Lubricant Did Not Reduce Infection Rate in Transrectal Biopsy Patients in a Large Randomized Trial Due to Low Complication Rates.,"BACKGROUND
Transrectal prostate biopsy (pbx) is the most frequent outpatient procedure in the urological field. Septic complications are a major health issue.
OBJECTIVE
To evaluate complication rates with or without an antimicrobial lubricant.
DESIGN, SETTING, AND PARTICIPANTS
A total of 1000 patients received pbx between 2013 and 2015. Information about complications was collected by a 3-wk questionnaire. Return rate was 73.2% (n=732).
INTERVENTION
Randomization for pbx with the instillation of an antimicrobial lubricant (intervention group, n=385) or the standard lubricant (control group, n=347) was performed.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Multivariable analyses assessed the association between infectious complications at biopsy and use of an antimicrobial lubricant, International Prostate Symptom Score (IPSS), history of urogenitourinary infections, and several other confounders.
RESULTS AND LIMITATIONS
The use of an antimicrobial lubricant did not reduce infection rate. Overall complication rate was very low. Of all patients, 69.3% described the procedure as pain free. Fever ≥38.5°C was reported in overall 1.9% of patients. Urinary retention with catheterization occurred in 3.1%. Most common complications were hematospermia (47.4%), macrohematuria (23.8%), and rectal bleeding (7.4%). Readmission rate was 1% (n=7). In multivariable analyses, IPSS and previous infectious complications were associated with a higher risk of infectious complications. Our results stem from a large German single center and therefore are limited to this patient group.
CONCLUSIONS
No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent. Low incidence of those complications may be the underlying cause. Severe morbidity at pbx is uncommon. Specifically, the rate of infection was very low.
PATIENT SUMMARY
Severe complications at prostate biopsy are rare. Among participants, 69.3% had no pain. Fever was rare (1.9% of patients). Voiding issues with catheterization occurred in 3.1%. Most common complications were blood in the semen (47.4%), urine (23.8%), or stool (7.4%). Men with voiding issues or previous infectious complications had a higher risk of infectious complications.",2019,No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent.,"['Transrectal Biopsy Patients', '1000 patients received pbx between 2013 and 2015']","['Transrectal prostate biopsy (pbx', 'Antimicrobial Lubricant', 'Randomization for pbx with the instillation of an antimicrobial lubricant (intervention group, n=385) or the standard lubricant (control group, n=347) was performed', 'antimicrobial lubricant']","['rate of infection', 'rectal bleeding', 'Voiding issues with catheterization', 'complication rates', 'infection rate', 'Severe complications', 'Readmission rate', 'Urinary retention with catheterization', 'infectious complications at biopsy and use of an antimicrobial lubricant, International Prostate Symptom Score (IPSS), history of urogenitourinary infections, and several other confounders', 'Septic complications', 'Return rate', 'Overall complication rate', 'infectious complications', 'Severe morbidity', 'Fever', 'Infection Rate']","[{'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",1000.0,0.128082,No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent.,"[{'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Salomon', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Prues', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Saul', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Budäus', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Tilki', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Department of Urology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haferkamp', 'Affiliation': 'Department of Urology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Graefen', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Boehm', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Medical Center, Johannes Gutenberg University, Mainz, Germany. Electronic address: katharina.boehm@unimedizin-mainz.de.'}]",European urology focus,['10.1016/j.euf.2018.06.005']
1447,30820755,Zhiqi Granules Decreased Lead Level but Increased Iron Level in Serum of Chinese Children with Moderately Elevated Blood Lead Levels.,"To observe and compare the effects of healthy instruction and Zhiqi granules on lead, calcium, iron, and zinc levels in serum of children with moderately elevated blood lead levels (BLLs). At the same time, the possible mechanisms were discussed. A total of 60 eligible boys aged 4-6 years were selected and divided into two groups (the healthy instruction group and the Zhiqi group) randomly. The boys in the healthy instruction group only received the healthy instruction. Besides the healthy instruction, the boys in the Zhiqi group received 2 g Zhiqi granules orally one time daily. The study lasted for 4 weeks. BLL and serum iron, zinc, and calcium levels of the subjects in the two groups before and after interventions were measured and compared. After the interventions, the BLL in the Zhiqi group lowered significantly, but the decrease of the BLL in the healthy instruction group is not significant, and there was a significant difference in the BLL between the two groups. When the trial was completed, the serum iron level in the Zhiqi group increased significantly, but that in the healthy instruction group changed slightly, and a significant difference was seen between the two groups. There were no significant differences in both serum Ca and Zn levels in these two groups before and after the interventions. Meanwhile, there were no significant differences in serum Ca and Zn levels between the two groups after the interventions. The results suggested that daily intake of Zhiqi granules for 4 weeks together with healthy instruction resulted in a decrease of the BLL and an elevation of the serum iron level.",2020,There were no significant differences in both serum Ca and Zn levels in these two groups before and after the interventions.,"['60 eligible boys aged 4-6\xa0years', 'children with moderately elevated blood lead levels (BLLs']","['healthy instruction and Zhiqi granules', 'healthy instruction']","['BLL and serum iron, zinc, and calcium levels', 'serum iron level', 'Ca and Zn levels', 'serum', 'serum Ca and Zn levels', 'lead, calcium, iron, and zinc levels', 'BLL', 'BLL and an elevation of the serum iron level']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0262463', 'cui_str': 'Raised blood lead level'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C3853573', 'cui_str': 'Granules'}]","[{'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0373748', 'cui_str': 'Zinc measurement (procedure)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",60.0,0.0242763,There were no significant differences in both serum Ca and Zn levels in these two groups before and after the interventions.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, First Hospital of Jilin University, 71# Xinmin Street, Changchun, 130021, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zou', 'Affiliation': 'Department of Pediatrics, First Hospital of Jilin University, 71# Xinmin Street, Changchun, 130021, China.'}, {'ForeName': 'Meihua', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Pediatrics, First Hospital of Jilin University, 71# Xinmin Street, Changchun, 130021, China.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, First Hospital of Jilin University, 71# Xinmin Street, Changchun, 130021, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, First Hospital of Jilin University, 71# Xinmin Street, Changchun, 130021, China. yyhuang14@mails.jlu.edu.cn.'}]",Biological trace element research,['10.1007/s12011-019-01680-z']
1448,30822414,"A Double-Blind, Randomized Trial Shows the Role of Zonal Priming and Direct Topical Application of Epigallocatechin-3-Gallate in the Modulation of Cutaneous Scarring in Human Skin.","BACKGROUND
Epigallocatechin-3-gallate (EGCG), a polyphenol, influences cutaneous wound healing because of its antiangiogenic, anti-inflammatory, and antioxidant properties. We previously showed the role of EGCG in scarring in ex vivo human scar models. Here, we evaluate direct application of topical EGCG compared with zonal priming, a unique concept in the immediate treatment of the zone of injury at the time of wounding before scar formation.
TRIAL DESIGN
Double-blind randomized controlled trial.
METHODS
We assessed EGCG application compared with placebo over 1-6 weeks in scars created in 62 human volunteers using quantitative noninvasive devices, immunohistochemical analysis, mRNA sequencing, and quantitative real-time reverse transcriptase-PCR of tissue biopsy samples.
RESULTS
EGCG reduced mast cells at weeks 1-3, as evidenced by gene and protein analyses (P ≤ 0.01). M2 macrophages were increased with EGCG compared with placebo. EGCG application by zonal priming significantly down-regulated VEGFA and CD31 at week 1 and at 1-2 weeks after direct application (P ≤ 0.01). Direct EGCG application also reduced scar thickness at weeks 1-3 (P = 0.001) and increased scar elasticity at week 4 (P = 0.01). Increased hydration was evident both noninvasively and by increased hyaluronic acid levels (P < 0.01) at week 3.
CONCLUSIONS
We show the beneficial role of both zonal priming and direct EGCG application in scar therapy with positive effects on scar thickness, erythema, hydration, and elasticity. Trial register: International standard randomized controlled trial, registration number ISRCTN 18643079; July 16, 2018.",2019,"Increased hydration was evident both noninvasively and by increased hyaluronic acid levels (P < 0.01) at week 3.
","['Cutaneous Scarring in\xa0Human\xa0Skin', '62 human volunteers']","['Direct EGCG', 'placebo', 'Epigallocatechin-3-gallate (EGCG', 'topical EGCG', 'Epigallocatechin-3-Gallate', 'zonal priming and direct EGCG application', 'EGCG']","['Increased hydration', 'EGCG application by zonal priming significantly down-regulated VEGFA and CD31', 'M2 macrophages', 'scar elasticity', 'scar thickness, erythema, hydration, and elasticity', 'hyaluronic acid levels', 'mast cells', 'scar thickness']","[{'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1564799', 'cui_str': 'Zonal'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1564799', 'cui_str': 'Zonal'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0013764'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024880', 'cui_str': 'Basophils, Tissue'}]",62.0,0.258746,"Increased hydration was evident both noninvasively and by increased hyaluronic acid levels (P < 0.01) at week 3.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ud-Din', 'Affiliation': 'Plastic and Reconstructive Surgery Research, University of Manchester, Manchester, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Foden', 'Affiliation': 'Medical Statistics, Manchester University Foundation Trust, Manchester, UK.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Mazhari', 'Affiliation': 'Adult Histopathology, Manchester University Foundation Trust, Manchester, UK.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Al-Habba', 'Affiliation': 'Adult Histopathology, Manchester University Foundation Trust, Manchester, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Baguneid', 'Affiliation': 'Vascular Surgery, Manchester University Foundation Trust, Manchester, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bulfone-Paus', 'Affiliation': 'Faculty of Biology, Medicine and Health, Centre for Dermatology Research, University of Manchester, Manchester, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'McGeorge', 'Affiliation': 'Grosvenor Nuffield Hospital, Chester, UK.'}, {'ForeName': 'Ardeshir', 'Initials': 'A', 'LastName': 'Bayat', 'Affiliation': 'Plastic and Reconstructive Surgery Research, University of Manchester, Manchester, UK. Electronic address: ardeshir.bayat@manchester.ac.uk.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.01.030']
1449,30811354,Tissue Adhesive for Wound Closure Reduces Immediate Postoperative Wound Dressing Changes After Primary TKA: A Randomized Controlled Study in Simultaneous Bilateral TKA.,"BACKGROUND
Prolonged wound drainage after TKA is associated with increased risk of infection. To decrease wound drainage, tissue adhesive has been suggested as an adjunct to wound closure after TKA; however, no studies of which we are aware have investigated the effect of tissue adhesive in a modern fast-track TKA setting.
QUESTIONS/PURPOSES
The purpose of this study was to evaluate the effect of wound closure using a high-viscosity tissue adhesive in simultaneous bilateral TKA with respect to (1) postoperative wound drainage, measured as number of dressing changes in the first 72 hours postoperatively; and (2) wound healing assessed using the ASEPSIS score.
METHODS
Thirty patients undergoing simultaneous bilateral TKA were included in the study. The left knee was randomized to receive either standard three-layer closure with staples or the same closure supplemented with tissue adhesive with the opposite treatment used on the contralateral knee. One patient underwent a constrained TKA and underwent revision 2 days after the index procedure and was therefore excluded leaving 29 patients (58 knees) for analysis. Sixty-two percent (n = 18) were female. Mean age was 64 years (range, 42-78 years). Mean body mass index was 28 kg/m (range, 21-38 kg/m). Postoperative wound drainage was evaluated as drainage resulting in a dressing change. The wound dressing was changed if it was soaked to the borders of the absorbable dressing at any point. The nurses changing the dressing were blinded to treatment allocation up to the first dressing change. The number of dressing changes during the first 72 hours postoperatively was recorded. The secondary study endpoint was the ASEPSIS score, which is a clinical score assessing wound healing. ASEPSIS score, measured by a nurse not involved in the treatment, was compared between the groups at 3 weeks followup.
RESULTS
Knees with tissue adhesive underwent fewer dressing changes (median, 0; interquartile range [IQR], 0-1) compared with the contralateral knee (IQR, 1-2; difference of medians, one dressing change; p = 0.001). A total of 59% of knees in the intervention group did not undergo any dressing changes before discharge, whereas 24% of knees in the control group did not undergo any dressing changes before discharge (p = 0.02). The knees in the intervention group and the control group did not differ with respect to ASEPSIS score at 3 weeks.
CONCLUSIONS
Tissue adhesive as an adjunct to standard wound closure after primary TKA reduced the number of dressing changes after surgery, but did not change the appearance or healing of the wound at 3 weeks based on the ASEPSIS scores. Whether the small differences observed here in terms of the number of dressing changes performed will justify the additional costs associated with using this product or whether there are other differences associated with the use of tissue adhesive that may prove important such as patient preferences or longer term differences in wound healing or infection should be studied in the future.
LEVEL OF EVIDENCE
Level I, therapeutic study.",2019,"The knees in the intervention group and the control group did not differ with respect to ASEPSIS score at 3 weeks.
","['Mean age was 64 years (range, 42-78 years', 'After Primary TKA', 'Thirty patients undergoing simultaneous bilateral TKA were included in the study', 'Sixty-two percent (n = 18) were female']","['constrained TKA', 'standard three-layer closure with staples or the same closure supplemented with tissue adhesive with the opposite treatment used on the contralateral knee']","['Mean body mass index', 'appearance or healing of the wound', 'Postoperative wound drainage', 'ASEPSIS score, which is a clinical score assessing wound healing', 'number of dressing changes']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1293123', 'cui_str': 'Layered closure - action'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0040277', 'cui_str': 'Tissue Adhesives'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0920263', 'cui_str': 'Wound drainage'}, {'cui': 'C0003974', 'cui_str': 'Asepsis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}]",30.0,0.0535058,"The knees in the intervention group and the control group did not differ with respect to ASEPSIS score at 3 weeks.
","[{'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Gromov', 'Affiliation': 'K. Gromov, A. Troelsen, S. Raaschou, H. Sandhold, C. Skovgaard Nielsen, H. Husted, Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark H. Kehlet, Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': ''}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Raaschou', 'Affiliation': ''}, {'ForeName': 'Håkon', 'Initials': 'H', 'LastName': 'Sandhold', 'Affiliation': ''}, {'ForeName': 'Christian Skovgaard', 'Initials': 'CS', 'LastName': 'Nielsen', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Husted', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000637']
1450,30099602,Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC).,"PURPOSE
Optimal primary febrile neutropenia (FN) prophylaxis (i.e. ciprofloxacin or granulocyte-colony stimulating factors [G-CSF]) for patients receiving docetaxel-cyclophosphamide (TC) chemotherapy is unknown. We assessed the feasibility of using a novel pragmatic comparative effectiveness trial to compare these standard-of-care options.
METHODS
Early-stage breast cancer patients receiving TC chemotherapy were randomised to either ciprofloxacin or G-CSF. Trial methodology consists of broad eligibility criteria, simply-defined endpoints, integrated consent model incorporating oral consent, and web-based randomisation in the clinic. Primary feasibility endpoints included patient and physician engagement (if > 50% of patients approached agree to participate and if > 50% of physicians approached patients for the study). Secondary clinical endpoints included the following: first occurrence rates of FN, treatment-related hospitalisation, or chemotherapy dose reduction/delay/discontinuation, as well as patient satisfaction with the oral consent process.
RESULTS
Of 204 patients approached, 91.2% (186/204) agreed to randomisation. Sixteen of twenty (80%) participating medical oncologists randomised patients. Median patient age was 57.7 (range 31.8-84.1). The 186 patients received 557 cycles of chemotherapy. Overall incidences of first events by patient (n = 186) were as follows: FN (18/186, 21.43%), treatment-related hospitalisation (11/186, 13.10%), chemotherapy reduction (19/186, 22.62%), chemotherapy discontinuation (16/186, 19.05%), and chemotherapy delays (5/186, 5.95%). A total of 37.77% (69/186) of patients and 12.39% (69/557) of chemotherapy cycles had at least one of these first events. Patients were highly satisfied with the oral consent process.
CONCLUSION
This study met its feasibility endpoints. This model offers a means of comparing standard-of-care treatments in a practical and cost-efficient manner.
TRIAL REGISTRATION
Trial registration: ClinicalTrials.gov : NCT02173262.",2019,"Secondary clinical endpoints included the following: first occurrence rates of FN, treatment-related hospitalisation, or chemotherapy dose reduction/delay/discontinuation, as well as patient satisfaction with the oral consent process.
","['204 patients approached, 91.2% (186/204) agreed to randomisation', 'Patients were highly satisfied with the oral consent process', 'for breast cancer (REaCT-TC', 'Median patient age was 57.7 (range 31.8-84.1', 'Early-stage breast cancer patients receiving', 'Sixteen of twenty (80%) participating medical oncologists randomised patients', '186 patients received 557 cycles of', 'patients receiving']","['chemotherapy', 'TC chemotherapy', 'ciprofloxacin or granulocyte-colony stimulating factors [G-CSF', 'ciprofloxacin or G-CSF', 'docetaxel-cyclophosphamide (TC) chemotherapy', 'docetaxel-cyclophosphamide chemotherapy', 'ciprofloxacin versus G-CSF']","['treatment-related hospitalisation', 'patient and physician engagement', 'Overall incidences of first events', 'chemotherapy reduction', 'occurrence rates of FN, treatment-related hospitalisation, or chemotherapy dose reduction/delay/discontinuation, as well as patient satisfaction with the oral consent process']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1555767', 'cui_str': 'Medical oncologist (occupation)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",204.0,0.0661823,"Secondary clinical endpoints included the following: first occurrence rates of FN, treatment-related hospitalisation, or chemotherapy dose reduction/delay/discontinuation, as well as patient satisfaction with the oral consent process.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada. mclemons@toh.ca.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Mazzarello', 'Affiliation': 'Cancer Research Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Joy', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Price-Hiller', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Canada.'}, {'ForeName': 'Xiaofu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Canada.'}, {'ForeName': 'Shailendra', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kehoe', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Mohammed Fk', 'Initials': 'MF', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sienkiewicz', 'Affiliation': 'Cancer Research Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Research Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Research Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4408-6']
1451,31462137,The impact of neutrophil-lymphocyte ratio on risk reclassification of patients with advanced renal cell cancer to guide risk-directed therapy.,"Background: An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC). We examined whether the addition of NLR improves the risk reclassification of advanced RCC using current prognostic tools from the Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Methods: Using randomised data from the COMPARZ trial of first-line pazopanib vs. sunitinib in advanced RCC, we constructed multivariable models containing MSKCC and IMDC predictor variables with and without NLR. We evaluated model discrimination using the concordance index (C-index). We computed net reclassification improvement to quantify patient reclassification into low/intermediate/poor risk groups with the addition of NLR. Results: Of 1102 patients, NLR ≥ 5 (16%) was associated with shorter survival adjusting for MSKCC variables (adjusted HR 1.89, p < .001). Adding NLR to MSKCC variables increased the C-index by 0.01. Among patients who died before 24 months ( N = 415), adding NLR reclassified 8% and 2% to a higher and lower risk category, respectively. Among those alive at 24 months ( N = 636), adding NLR reclassified 4% and 1% to a higher and lower risk category, respectively. This finding translates to a net benefit of eight additional patients who die within 24 months correctly identified as poor risk per 1000 patients tested. We obtained similar results when evaluating NLR with IMDC variables. Conclusions: NLR does not substantially improve risk reclassification over pre-existing prognostic tools. MSKCC and IMDC classifications remain the standard for guiding risk-directed therapy and trial stratification of patients with advanced RCC.",2020,An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC).,"['advanced renal cell carcinoma (RCC', 'patients with advanced RCC', 'patients with advanced renal cell cancer to guide risk-directed therapy']","['pazopanib vs. sunitinib', 'NLR', 'neutrophil-lymphocyte ratio']","['elevated neutrophil-lymphocyte ratio (NLR', 'shorter survival adjusting for MSKCC variables', 'C-index']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",1102.0,0.032522,An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC).,"[{'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tjokrowidjaja', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Translational Cancer Research Network, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'H Malcolm', 'Initials': 'HM', 'LastName': 'Hudson', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Lord', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'de Souza', 'Affiliation': 'Department of Medical Oncology, Liverpool Hospital, Liverpool, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Chee Khoon', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2019.1656342']
1452,30793735,Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE).,"AIMS
This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months.
METHODS AND RESULTS
The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0-30)/(1-30) vs. 10/10 min (0-40)/(1-40) in HM + IO (P < 0.0001).
CONCLUSION
The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.",2019,There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15.,"['445 patients in two groups, both followed by', 'patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24\u2009months', 'Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients']",['RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO'],"['safety and efficiency', 'Safety and efficiency', 'time a physician/nurse spent per patient/follow-up', '≥1 major adverse cardiac event (MACE', 'unscheduled visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0585339', 'cui_str': 'q6mo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",445.0,0.0452613,There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15.,"[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'García-Fernández', 'Affiliation': 'Arrythmia Unit, Cardiology Department, Hospital Universitario de Burgos, Av. Islas Baleares 3, Burgos, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Osca Asensi', 'Affiliation': 'Hospital Universitario y Politécnico La Fe, Av de Fernando Abril Martorell 106, Valencia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romero', 'Affiliation': 'Hospital Nuestra Señora de la Candelaria, Ctra. Gral. del Rosario 145, Sta. Cruz de Tenerife, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Fernández Lozano', 'Affiliation': 'Hospital U Puerta de Hierro, Manuel de Falla 1, Madrid, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Larrazabal', 'Affiliation': 'Hospital San Pedro de Alcántara, Av Pablo Naranjo s/n, Cáceres, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Martínez Ferrer', 'Affiliation': 'Hospital Universitario Araba, Jose Atxotegi s/n, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Ortiz', 'Affiliation': 'Hospital General de la Palma, Ctra. de la Cumbre 28, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pombo', 'Affiliation': 'Hospital Costa del Sol, A-7 Km 187, Marbella, Málaga, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Tornés', 'Affiliation': 'Hospital Torrecárdenas, Calle Hermandad de Donantes de Sangre s/n, Almería, Spain.'}, {'ForeName': 'Mehrard', 'Initials': 'M', 'LastName': 'Moradi Kolbolandi', 'Affiliation': ""Hospital Vall d`Hebron, Passeig de la Vall d'Hebron 119-129, Barcelona, Spain.""}]",European heart journal,['10.1093/eurheartj/ehz067']
1453,30661255,The Nonsteroidal Farnesoid X Receptor Agonist Cilofexor (GS-9674) Improves Markers of Cholestasis and Liver Injury in Patients With Primary Sclerosing Cholangitis.,"Primary sclerosing cholangitis (PSC) represents a major unmet medical need. In a phase II double-blind, placebo-controlled study, we tested the safety and efficacy of cilofexor (formerly GS-9674), a nonsteroidal farnesoid X receptor agonist in patients without cirrhosis with large-duct PSC. Patients were randomized to receive cilofexor 100 mg (n = 22), 30 mg (n = 20), or placebo (n = 10) orally once daily for 12 weeks. All patients had serum alkaline phosphatase (ALP) > 1.67 × upper limit of normal and total bilirubin ≤ 2 mg/dL at baseline. Safety, tolerability, pharmacodynamic effects of cilofexor (serum C4 [7α-hydroxy-4-cholesten-3-one] and bile acids), and changes in liver biochemistry and serum fibrosis markers were evaluated. Overall, 52 patients were randomized (median age 43 years, 58% male, 60% with inflammatory bowel disease, 46% on ursodeoxycholic acid). Baseline median serum ALP and bilirubin were 348 U/L (interquartile range 288-439) and 0.7 mg/dL (0.5-1.0), respectively. Dose-dependent reductions in liver biochemistry were observed. At week 12, cilofexor 100 mg led to significant reductions in serum ALP (median reduction -21%; P = 0.029 versus placebo), gamma-glutamyl transferase (-30%; P < 0.001), alanine aminotransferase (ALT) (-49%; P = 0.009), and aspartate aminotransferase (-42%; P = 0.019). Cilofexor reduced serum C4 compared with placebo; reductions in bile acids were greatest with 100 mg. Relative reductions in ALP were similar between ursodeoxycholic acid-treated and untreated patients. At week 12, cilofexor-treated patients with a 25% or more relative reduction in ALP had greater reductions in serum alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, tissue inhibitor of metalloproteinase 1, C-reactive protein, and bile acids than nonresponders. Adverse events were similar between cilofexor and placebo-treated patients. Rates of grade 2 or 3 pruritus were 14% with 100 mg, 20% with 30 mg, and 40% with placebo. Conclusion: In this 12-week, randomized, placebo-controlled study, cilofexor was well tolerated and led to significant improvements in liver biochemistries and markers of cholestasis in patients with PSC.",2019,All patients had serum alkaline phosphatase (ALP) > 1.67 × upper limit of normal and total bilirubin ≤ 2 mg/dL at baseline.,"['52 patients were randomized (median age 43 years, 58% male, 60% with inflammatory bowel disease, 46% on ursodeoxycholic acid', 'patients without cirrhosis with large-duct PSC', 'Patients With Primary Sclerosing Cholangitis', 'patients with PSC']","['Nonsteroidal Farnesoid X Receptor Agonist Cilofexor (GS-9674', 'nonsteroidal farnesoid X receptor agonist', 'placebo', 'cilofexor', 'cilofexor (formerly GS-9674', 'ursodeoxycholic acid']","['gamma-glutamyl transferase', 'safety and efficacy', 'aspartate aminotransferase', 'Adverse events', 'serum alkaline phosphatase (ALP', 'bile acids', 'liver biochemistry', 'liver biochemistries and markers of cholestasis', 'ALP', 'Baseline median serum ALP and bilirubin', 'Cholestasis and Liver Injury', 'serum ALP', 'alanine aminotransferase (ALT', 'Rates of grade 2 or 3 pruritus', 'Safety, tolerability, pharmacodynamic effects of cilofexor (serum C4 [7α-hydroxy-4-cholesten-3-one] and bile acids), and changes in liver biochemistry and serum fibrosis markers', 'serum alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, tissue inhibitor of metalloproteinase 1, C-reactive protein, and bile acids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis (disorder)'}]","[{'cui': 'C4707406', 'cui_str': 'Product containing farnesoid X receptor agonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}]","[{'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0008370', 'cui_str': 'Bile Duct Obstruction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0055520', 'cui_str': 'cholest-4-en-3-one'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0145947', 'cui_str': 'TIMP-1'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",52.0,0.370652,All patients had serum alkaline phosphatase (ALP) > 1.67 × upper limit of normal and total bilirubin ≤ 2 mg/dL at baseline.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Gulamhusein', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Hameed', 'Affiliation': 'University of California, San Francisco School of Medicine, San Francisco, CA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Caldwell', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Bon Secours Liver Institute, Richmond, VA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Landis', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Bertus', 'Initials': 'B', 'LastName': 'Eksteen', 'Affiliation': 'Aspen Woods Clinic, Calgary, AB, Canada.'}, {'ForeName': 'Kosh', 'Initials': 'K', 'LastName': 'Agarwal', 'Affiliation': ""King's College, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Muir', 'Affiliation': 'Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rushbrook', 'Affiliation': 'Norfolk and Norwich University Hospital, Norfolk, UK.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Jen-Chieh', 'Initials': 'JC', 'LastName': 'Chuang', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Billin', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Chuhan', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'University of California Davis, Davis, CA.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Care Network and Organ Care Research, Swedish Medical Center, Seattle, WA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30509']
1454,30807636,Timing Modulates the Effect of Sleep Loss on Glucose Homeostasis.,"CONTEXT
Chronobiological factors may modulate the impact of sleep loss on glucose homeostasis. However, these interactions have not been systematically assessed in humans.
OBJECTIVE
To assess the effect of sleep loss during the late vs early night on glucose homeostasis.
DESIGN
Fifteen normal-weight men participated in three conditions of a randomized, balanced crossover study comprising two conditions with shortened sleep (i.e., 4 hours of sleep during the first or the second half of the night) and a control condition with 8 hours of sleep. Glucose, insulin, cortisol, and glucagon were measured. Insulin sensitivity and secretion were assessed with a Botnia clamp.
RESULTS
Compared with regular sleep duration, sleep loss reduced insulin sensitivity (M-value; P = 0.031) irrespective of early- or late-night timing (P = 0.691). The disposition index (i.e., the β-cell response adjusted for insulin sensitivity) also tended to be impaired by short sleep (P = 0.056) but not by sleep timing (P = 0.543). In contrast, sleep loss in the second half but not the first half of the night induced reductions in morning glucagon and cortisol levels (P < 0.031) followed by a transient increase in cortisol (P < 0.044).
CONCLUSIONS
Although sleep deprivation acutely reduced insulin sensitivity irrespective of its nocturnal timing, sleep loss in the early morning compromised α-cell and hypothalamic-pituitary-adrenal axis activity to a greater extent than sleep loss in the first half of the night. This pattern suggests that the timing of sleep restriction can partly potentiate its deleterious metabolic effects.",2019,"Compared with regular sleep duration, sleep loss reduced insulin sensitivity (M-value; P = 0.031) irrespective of early- or late-night timing (P = 0.691).",['Fifteen normal-weight men'],[],"['disposition index', 'Insulin sensitivity and secretion', 'insulin sensitivity', 'sleep loss', 'morning glucagon and cortisol levels', 'Glucose, insulin, cortisol, and glucagon']","[{'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",2.0,0.0168026,"Compared with regular sleep duration, sleep loss reduced insulin sensitivity (M-value; P = 0.031) irrespective of early- or late-night timing (P = 0.691).","[{'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Wilms', 'Affiliation': 'Department of Internal Medicine I, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Chamorro', 'Affiliation': 'Department of Internal Medicine I, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Hallschmid', 'Affiliation': 'German Center for Diabetes Research, Munich-Neuherberg, Germany.'}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Trost', 'Affiliation': 'Department of Internal Medicine I, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Forck', 'Affiliation': 'Department of Internal Medicine I, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Schultes', 'Affiliation': 'eSwiss Medical & Surgical Center, St. Gallen, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Mölle', 'Affiliation': 'Center of Brain, Behavior & Metabolism, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Friedhelm', 'Initials': 'F', 'LastName': 'Sayk', 'Affiliation': 'Sana Hospital, Lübeck, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Lehnert', 'Affiliation': 'Department of Internal Medicine I, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Schmid', 'Affiliation': 'Department of Internal Medicine I, University of Lübeck, Lübeck, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02636']
1455,27401241,A Randomized Effectiveness Trial of a Behavioral Teacher Program Targeting ADHD Symptoms.,"OBJECTIVE
This study investigated the effectiveness of the Positivity & Rules Program (PR program), a behavioral teacher program targeting ADHD symptoms in the classroom involving both student-focused and classroom-focused programs.
METHOD
Primary school children with ADHD symptoms ( N = 114) were randomly assigned to the PR program ( n = 58) or control group ( n = 56). Teacher and parent ratings were used to assess behavioral, social, and emotional functioning at baseline, during and after the intervention. Intervention effects were assessed using intention-to-treat multilevel analyses.
RESULTS
Teachers reported positive effects on ADHD symptoms and social skills (.01 < f 2 > .36). Effects did not generalize to the home setting.
CONCLUSION
The PR program holds promise for improving classroom behavior in children with ADHD symptoms and might prevent escalation of problem behavior.",2019,"Teacher and parent ratings were used to assess behavioral, social, and emotional functioning at baseline, during and after the intervention.","['Primary school children with ADHD symptoms ( N = 114', 'children with ADHD symptoms']","['PR program', 'Behavioral Teacher Program', 'Positivity & Rules Program (PR program']","['behavioral, social, and emotional functioning', 'ADHD symptoms and social skills']","[{'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}]",114.0,0.0267978,"Teacher and parent ratings were used to assess behavioral, social, and emotional functioning at baseline, during and after the intervention.","[{'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Veenman', 'Affiliation': '1 Vrije Universiteit Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Luman', 'Affiliation': '1 Vrije Universiteit Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoeksma', 'Affiliation': '1 Vrije Universiteit Amsterdam, The Netherlands.'}, {'ForeName': 'Karlijn', 'Initials': 'K', 'LastName': 'Pieterse', 'Affiliation': '1 Vrije Universiteit Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': '1 Vrije Universiteit Amsterdam, The Netherlands.'}]",Journal of attention disorders,['10.1177/1087054716658124']
1456,29550184,Correlation between Surgeon's assessment and radiographic evaluation of residual disease in women with advanced stage ovarian cancer reported to have undergone optimal surgical cytoreduction: An NRG Oncology/Gynecologic Oncology Group study.,"PURPOSE
We sought to determine the level of concordance among surgeons' assessment of residual disease (RD) and pre-treatment computed tomography (CT) findings among women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer.
METHODS
This is a post-trial ad hoc analysis of a phase 3 randomized clinical trial evaluating the impact of bevacizumab in primary and maintenance therapy for patients with advanced stage ovarian cancer following surgical cytoreduction. All subjects underwent imaging of the chest/abdomen/pelvis to establish a post-surgical baseline prior to the initiation of chemotherapy. Information collected on trial was utilized to compare surgeon's operative assessment of RD, to pre-treatment imaging.
RESULTS
Of 1873 enrolled patients, surgical outcome was described as optimal (RD≤1cm) in 639 subjects. Twelve patients were excluded as they did not have a baseline, pretreatment imaging, leaving 627 participants for analysis. The average interval from surgery to baseline scan was 26days (range: 1-109). In 251 cases (40%), the post-operative scan was discordant with surgeon assessment, demonstrating RD>1cm in size. RD>1cm was most commonly identified in the right upper quadrant (28.4%), retroperitoneal para-aortic lymph nodes (RD>1.5cm; 28.2%) and the left upper quadrant (10.7%). Patients with RD>1cm on pre-treatment CT (discordant) exhibited a significantly greater risk of disease progression (HR 1.30; 95% CI 1.08-1.56; p=0.0059).
CONCLUSIONS
Among patients reported to have undergone optimal cytoreduction, 40% were found to have lesions >1cm on postoperative, pretreatment imaging. Although inflammatory changes and/or rapid tumor regrowth could account for the discordance, the impact on PFS and distribution of RD may suggest underestimation by the operating surgeon.",2018,"RD>1cm was most commonly identified in the right upper quadrant (28.4%), retroperitoneal para-aortic lymph nodes (RD>1.5cm; 28.2%) and the left upper quadrant (10.7%).","['1873 enrolled patients, surgical outcome was described as optimal (RD≤1cm) in 639 subjects', 'patients with advanced stage ovarian cancer following surgical cytoreduction', 'Twelve patients were excluded as they did not have a baseline, pretreatment imaging, leaving 627 participants for analysis', 'women with advanced stage ovarian cancer', 'women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer', 'Patients with RD>1cm on']","['bevacizumab', 'residual disease (RD) and pre-treatment computed tomography (CT']","['risk of disease progression', 'retroperitoneal para-aortic lymph nodes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal Space'}, {'cui': 'C0229789', 'cui_str': 'Para-aortic node (body structure)'}]",1873.0,0.0889757,"RD>1cm was most commonly identified in the right upper quadrant (28.4%), retroperitoneal para-aortic lymph nodes (RD>1.5cm; 28.2%) and the left upper quadrant (10.7%).","[{'ForeName': 'Ramez N', 'Initials': 'RN', 'LastName': 'Eskander', 'Affiliation': 'University of California, San Diego Medical Center, La Jolla, CA, United States. Electronic address: Reskander@ucsd.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kauderer', 'Affiliation': 'NRG Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY, United States. Electronic address: kaudererJ@NRGOncology.org.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California, Irvine Medical Center, Orange, CA, United States. Electronic address: ktewari@uci.edu.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': 'University of Oklahoma, Oklahoma City, OK, United States. Electronic address: Robert_Mannel@ouhsc.edu.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Bristow', 'Affiliation': 'University of California, Irvine Medical Center, Orange, CA, United States. Electronic address: rbristow@uci.edu.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Ohio State University and Wexner Medical Center, Columbus, OH, United States. Electronic address: omalley.46@osu.edu.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Rubin', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States; Chief of Gynecologic Oncology at Fox Chase Cancer Center, Philadelphia, PA. Electronic address: Stephen.rubin@fccc.edu.'}, {'ForeName': 'Gretchen E', 'Initials': 'GE', 'LastName': 'Glaser', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States. Electronic address: Glaser.Gretchen@mayo.edu.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Hamilton', 'Affiliation': 'Gynecologic Cancer Center of Excellence, John P. Murtha Cancer Center, Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences, Bethesda, MD, United States. Electronic address: chad.a.hamilton2.mil@mail.mil.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Warner K', 'Initials': 'WK', 'LastName': 'Huh', 'Affiliation': 'University of Alabama Medical Center, Birmingham, AL, United States. Electronic address: whuh@uabmc.edu.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Ueland', 'Affiliation': 'University of Kentucky Medical Center, Lexington, KY, United States. Electronic address: fuela0@uky.edu.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Stephan', 'Affiliation': 'University of Iowa Hospital; Iowa City, IA, United States. Electronic address: jean-marie-stephan@uiowa.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States. Electronic address: burgerr@uphs.upenn.edu.'}]",Gynecologic oncology,['10.1016/j.ygyno.2018.03.043']
1457,30729881,Outcomes of a Problem-Solving Medication Management Intervention for Informal Caregivers.,"Older adults with memory loss often require assistance from caregivers to manage their medications. This study examined the efficacy of a problem-solving-based intervention focused on caregiver medication management, problem solving, self-efficacy, and daily hassles. Caregiver health-related quality of life (HRQoL) and patient health care utilization were secondary outcomes. Totally, 83 patients (age 79.9±8.8 years) and their informal caregivers (age 66.9±12 years, female 69.9%, White 85.5%) were randomized; data collection occurred at baseline, 8, 16, and 24 weeks. Linear mixed modeling showed significant decreases in medication deficiencies which were sustained over time. No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time. In addition, caregiver self-efficacy and mental HRQoL decreased in both groups. Physical HRQoL decreased in the intervention group, yet increased in the usual care group. Future research should investigate these outcomes in larger and more diverse samples.",2019,"No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time.","['Older adults with memory loss', 'Informal Caregivers', '83 patients (age 79.9±8.8 years) and their informal caregivers (age 66.9±12 years, female 69.9%, White 85.5']","['problem-solving-based intervention', 'Problem-Solving Medication Management Intervention']","['Physical HRQoL', 'caregiver problem solving, daily hassles, or patient health care utilization', 'caregiver self-efficacy and mental HRQoL', 'medication deficiencies', 'Caregiver health-related quality of life (HRQoL) and patient health care utilization']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751295', 'cui_str': 'Memory Loss'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",83.0,0.037252,"No significant changes in caregiver problem solving, daily hassles, or patient health care utilization occurred between groups or over time.","[{'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Erlen', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Tamres', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Fengyan', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lingler', 'Affiliation': 'University of Pittsburgh, PA, USA.'}]",Western journal of nursing research,['10.1177/0193945919825844']
1458,30806619,Cognitive-behavioural therapy for clozapine-resistant schizophrenia: the FOCUS RCT.,"BACKGROUND
Clozapine (clozaril, Mylan Products Ltd) is a first-choice treatment for people with schizophrenia who have a poor response to standard antipsychotic medication. However, a significant number of patients who trial clozapine have an inadequate response and experience persistent symptoms, called clozapine-resistant schizophrenia (CRS). There is little evidence regarding the clinical effectiveness of pharmacological or psychological interventions for this population.
OBJECTIVES
To evaluate the clinical effectiveness and cost-effectiveness of cognitive-behavioural therapy (CBT) for people with CRS and to identify factors predicting outcome.
DESIGN
The Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial was a parallel-group, randomised, outcome-blinded evaluation trial. Randomisation was undertaken using permuted blocks of random size via a web-based platform. Data were analysed on an intention-to-treat (ITT) basis, using random-effects regression adjusted for site, age, sex and baseline symptoms. Cost-effectiveness analyses were carried out to determine whether or not CBT was associated with a greater number of quality-adjusted life-years (QALYs) and higher costs than treatment as usual (TAU).
SETTING
Secondary care mental health services in five cities in the UK.
PARTICIPANTS
People with CRS aged ≥ 16 years, with an International Classification of Diseases , Tenth Revision (ICD-10) schizophrenia spectrum diagnoses and who are experiencing psychotic symptoms.
INTERVENTIONS
Individual CBT included up to 30 hours of therapy delivered over 9 months. The comparator was TAU, which included care co-ordination from secondary care mental health services.
MAIN OUTCOME MEASURES
The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 21 months and the primary secondary outcome was PANSS total score at the end of treatment (9 months post randomisation). The health benefit measure for the economic evaluation was the QALY, estimated from the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), health status measure. Service use was measured to estimate costs.
RESULTS
Participants were allocated to CBT ( n = 242) or TAU ( n = 245). There was no significant difference between groups on the prespecified primary outcome [PANSS total score at 21 months was 0.89 points lower in the CBT arm than in the TAU arm, 95% confidence interval (CI) -3.32 to 1.55 points; p = 0.475], although PANSS total score at the end of treatment (9 months) was significantly lower in the CBT arm (-2.40 points, 95% CI -4.79 to -0.02 points; p = 0.049). CBT was associated with a net cost of £5378 (95% CI -£13,010 to £23,766) and a net QALY gain of 0.052 (95% CI 0.003 to 0.103 QALYs) compared with TAU. The cost-effectiveness acceptability analysis indicated a low likelihood that CBT was cost-effective, in the primary and sensitivity analyses (probability < 50%). In the CBT arm, 107 participants reported at least one adverse event (AE), whereas 104 participants in the TAU arm reported at least one AE (odds ratio 1.09, 95% CI 0.81 to 1.46; p = 0.58).
CONCLUSIONS
Cognitive-behavioural therapy for CRS was not superior to TAU on the primary outcome of total PANSS symptoms at 21 months, but was superior on total PANSS symptoms at 9 months (end of treatment). CBT was not found to be cost-effective in comparison with TAU. There was no suggestion that the addition of CBT to TAU caused adverse effects. Future work could investigate whether or not specific therapeutic techniques of CBT have value for some CRS individuals, how to identify those who may benefit and how to ensure that effects on symptoms can be sustained.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN99672552.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 7. See the NIHR Journals Library website for further project information.",2019,"There was no significant difference between groups on the prespecified primary outcome [PANSS total score at 21 months was 0.89 points lower in the CBT arm than in the TAU arm, 95% confidence interval (CI) -3.32 to 1.55 points; p = 0.475], although PANSS total score at the end of treatment (9 months) was significantly lower in the CBT arm (-2.40 points, 95% CI -4.79 to -0.02 points; p = 0.049).","['resistant schizophrenia', 'people with CRS', 'People with CRS aged ≥ 16 years, with an International Classification of Diseases , Tenth Revision (ICD-10) schizophrenia spectrum diagnoses and who are experiencing psychotic symptoms', 'people with schizophrenia who have a poor response to standard antipsychotic medication', 'Secondary care mental health services in five cities in the UK']","['Clozapine (clozaril, Mylan Products Ltd', 'clozapine', 'CBT', 'TAU', 'cognitive-behavioural therapy (CBT']","['adverse event (AE', 'adverse effects', 'PANSS total score', 'net QALY gain', 'Positive and Negative Syndrome Scale (PANSS) total score', 'total PANSS symptoms', 'cost-effectiveness acceptability']","[{'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205444', 'cui_str': 'Tenth (qualifier value)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0009079', 'cui_str': 'Clozapine'}, {'cui': 'C0719386', 'cui_str': 'Clozaril'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.17251,"There was no significant difference between groups on the prespecified primary outcome [PANSS total score at 21 months was 0.89 points lower in the CBT arm than in the TAU arm, 95% confidence interval (CI) -3.32 to 1.55 points; p = 0.475], although PANSS total score at the end of treatment (9 months) was significantly lower in the CBT arm (-2.40 points, 95% CI -4.79 to -0.02 points; p = 0.049).","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Morrison', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pyle', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gumley', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwannauer', 'Affiliation': 'Department of Clinical Psychology, Edinburgh Medical School, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Turkington', 'Affiliation': 'Academic Psychiatry, Northumberland, Tyne and Wear NHS Foundation Trust, Centre for Ageing and Vitality, Newcastle General Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Clinical Trials Unit, Edinburgh Medical School, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bowe', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hutton', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Byrne', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Syrett', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dudley', 'Affiliation': 'School of Psychology, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Hamish J', 'Initials': 'HJ', 'LastName': 'McLeod', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Griffiths', 'Affiliation': 'Department of Clinical Psychology, Edinburgh Medical School, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Thomas Re', 'Initials': 'TR', 'LastName': 'Barnes', 'Affiliation': 'Centre for Mental Health, Imperial College London, London, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': 'Division of Population Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Shields', 'Affiliation': 'Division of Population Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Buck', 'Affiliation': 'Division of Population Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tully', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'Department of Psychiatry, University of Southampton, Academic Centre, Southampton, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23070']
1459,30795951,"Adjuvant denosumab in postmenopausal patients with hormone receptor-positive breast cancer (ABCSG-18): disease-free survival results from a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND
In postmenopausal women with hormone receptor-positive, early-stage breast cancer, treatment with adjuvant aromatase inhibitors is the standard of care, but it increases risk for osteoporosis and fractures. Results from the ABCSG-18 trial showed that use of denosumab as an adjuvant to aromatase inhibitor therapy significantly reduced clinical fractures. Disease-free survival outcomes from ABCSG-18 have not yet been reported.
METHODS
Postmenopausal patients with early, hormone receptor-positive, non-metastatic adenocarcinoma of the breast, who had completed their initial adjuvant treatment pathway (surgery, radiotherapy, or chemotherapy, or a combination) and were receiving adjuvant aromatase inhibitors, were enrolled at 58 trial centres in Austria and Sweden into this prospective, double-blind, placebo-controlled, phase 3 trial. With permuted block randomisation (block sizes 2 and 4, stratified by previous aromatase inhibitor use, total lumbar spine bone mineral density score at baseline, and type of centre), patients were assigned (1:1) to receive subcutaneous denosumab (60 mg) or matching placebo every 6 months during aromatase inhibitor therapy. The primary endpoint (previously reported) was the time to first clinical fracture after randomisation. The secondary endpoint reported here is disease-free survival (defined as time from randomisation to first evidence of local or distant metastasis, contralateral breast cancer, secondary carcinoma, or death from any cause) in the intention-to-treat population. This study is registered with EudraCT (number 2005-005275-15) and ClinicalTrials.gov (number NCT00556374), and is ongoing for long-term follow-up.
FINDINGS
Between Dec 18, 2006, and July 22, 2013, 3425 eligible patients were enrolled and randomly assigned; 1711 to the denosumab group and 1709 to the placebo group (with five others withdrawing consent). After a median follow-up of 73 months (IQR 58-95), 240 (14·0%) patients in the denosumab and 287 (16·8%) in the placebo group had disease-free survival events. Disease-free survival was significantly improved in the denosumab group versus the placebo group (hazard ratio 0·82, 95% CI 0·69-0·98, Cox p=0·0260; descriptive analysis, without controlling for multiplicity). In the denosumab group, disease-free survival was 89·2% (95% CI 87·6-90·8) at 5 years and 80·6% (78·1-83·1) at 8 years of follow-up, compared with 87·3% (85·7-89·0) at 5 years and 77·5% (74·8-80·2) and 8 years in the placebo group. No independently adjudicated cases of osteonecrosis of the jaw or confirmed atypical femoral fractures were recorded. The total number of adverse events was similar in the denosumab group (1367 [including 521 serious] adverse events) and the placebo group (1339 [515 serious]). The most common serious adverse events were osteoarthritis (62 [3·6%] of 1709 in the denosumab group vs 58 [3·4%] of 1690 in the placebo group), meniscus injury (23 [1·3%] vs 24 [1·4%]), and cataract (16 [0·9%] vs 28 [1·7%]). One (<0·1%) treatment-related death (due to pneumonia, septic kidney failure, and cardiac decompensation) occurred in the denosumab group.
INTERPRETATION
Denosumab constitutes an effective and safe adjuvant treatment for patients with postmenopausal hormone receptor-positive early breast cancer receiving aromatase inhibitor therapy.
FUNDING
Amgen.",2019,"Disease-free survival was significantly improved in the denosumab group versus the placebo group (hazard ratio 0·82, 95% CI 0·69-0·98, Cox p=0·0260; descriptive analysis, without controlling for multiplicity).","['postmenopausal women with hormone receptor-positive, early-stage breast cancer', 'postmenopausal patients with hormone receptor-positive breast cancer (ABCSG-18', 'Postmenopausal patients with early, hormone receptor-positive, non-metastatic adenocarcinoma of the breast, who had completed their initial adjuvant treatment pathway (surgery, radiotherapy, or chemotherapy, or a combination) and were receiving', 'Between Dec 18, 2006, and July 22, 2013, 3425 eligible patients were enrolled and randomly assigned; 1711 to the denosumab group and 1709 to the', 'patients with postmenopausal hormone receptor-positive early breast cancer receiving aromatase inhibitor therapy']","['placebo', 'EudraCT', 'subcutaneous denosumab (60 mg) or matching placebo', 'Adjuvant denosumab', 'adjuvant aromatase inhibitors', 'denosumab']","['total number of adverse events', 'local or distant metastasis, contralateral breast cancer, secondary carcinoma, or death from any cause', 'disease-free survival', 'disease-free survival events', 'clinical fractures', 'osteonecrosis of the jaw or confirmed atypical femoral fractures', 'death (due to pneumonia, septic kidney failure, and cardiac decompensation', 'time to first clinical fracture', 'meniscus injury', 'Disease-free survival']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0334277', 'cui_str': 'Adenocarcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C1096616', 'cui_str': 'Contralateral breast cancer'}, {'cui': 'C0085668', 'cui_str': 'Secondary carcinoma'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0231187', 'cui_str': 'Decompensation (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1096124', 'cui_str': 'Meniscus injury'}]",3425.0,0.686592,"Disease-free survival was significantly improved in the denosumab group versus the placebo group (hazard ratio 0·82, 95% CI 0·69-0·98, Cox p=0·0260; descriptive analysis, without controlling for multiplicity).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria; Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria. Electronic address: michael.gnant@meduniwien.ac.at.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Pfeiler', 'Affiliation': 'Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria; Department of Gynaecology and Obstetrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Günther G', 'Initials': 'GG', 'LastName': 'Steger', 'Affiliation': 'Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Gynaecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Centre for Clinical Cancer and Immunology Trials, Cancer Cluster Salzburg, Salzburg, Austria; Salzburg Cancer Research Institute, Salzburg, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fitzal', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria; Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria; Breast Health Centre, Hospital of Sisters of Mercy Linz, Linz, Austria.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Wette', 'Affiliation': 'Breast Centre, Sankt Veit an der Glan, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Department of Oncology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Haslbauer', 'Affiliation': 'Department of Internal Medicine, Hospital Voecklabruck, Voecklabruck, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Melbinger-Zeinitzer', 'Affiliation': 'Department of Surgery, Hospital Wolfsberg, Wolfsberg, Austria.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Bjelic-Radisic', 'Affiliation': 'Department of Gynaecology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Jakesz', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria; Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marth', 'Affiliation': 'Department of Gynaecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sevelda', 'Affiliation': 'Department of Gynaecology, Hospital Hietzing, Vienna, Austria.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Mlineritsch', 'Affiliation': 'Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Centre for Clinical Cancer and Immunology Trials, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Exner', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria; Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fesl', 'Affiliation': 'Department of Statistics, Austrian Breast & Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Frantal', 'Affiliation': 'Department of Statistics, Austrian Breast & Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria; Department of Gynaecology and Obstetrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30862-3']
1460,30806092,"Video delivery of toxicology educational content versus textbook for asynchronous learning, using acetaminophen overdose as a topic.","Objectives: Advances in technology have brought with them innovations in delivery of medical educational content; for example, audio and video podcasts, flipped classroom learning, and e-books. These new modalities may be useful for delivery of content asynchronously, as an adjunct to traditional lecture-based and bedside clinical teaching. Here, we measured the differences in knowledge acquisition between medical students using a video-based content delivery method and students using a traditional method of asynchronous content delivery (a textbook chapter). We also measured student preferences regarding asynchronous content delivery. Methods: A 4.5-minute educational video was created by a content expert using VideoScribe software. Acetaminophen toxicity was selected as the sample topic. Survey Monkey software was used to create a pre-test, post-test, and to gather data regarding student preferences. Students were given the pre-test, then they were randomized to either read a chapter on acetaminophen overdose from an emergency medicine reference text or to view the video; they were then given the post-test and the preferences survey. The results were then categorized and analysed using descriptive statistics and linear regression. Results: Sixty-nine student responses were initiated, 14 of whom did not complete the full survey, leaving 55 students who were included in the final analysis. Fifteen first year, 27 second-year, 8 third-year, and 5 fourth-year students participated. Twenty-eight students were randomized to reading the textbook chapter, and 31 were randomized to view the video; 4 students in the textbook group did not finish the educational activity. On average, students who took the video training correctly answered 1.1 (95% CI: 0.1-2.2, p = .03) more questions correctly after adjusting for pretest score and year in medical school than those who read the textbook chapter. A preference for watching a video over reading a textbook chapter was expressed by 78.4% of students, while 98% of students either agreed or strongly agreed with the statement that they would be comfortable using the internet to learn new concepts. No students reported that they were very satisfied and 57% of students reported being satisfied reading the textbook chapter, while 93.3% were either satisfied or very satisfied viewing the video. Conclusions: Video delivery of educational content was associated with higher student satisfaction and relative improvement in score compared to textbook. Students overall expressed comfort using the internet and new technology to obtain new medical education. The authors were involved with creation of the video and quiz, which may confound results. Future exploration into retention of knowledge could be warranted.",2019,"A preference for watching a video over reading a textbook chapter was expressed by 78.4% of students, while 98% of students either agreed or strongly agreed with the statement that they would be comfortable using the internet to learn new concepts.","['Twenty-eight students', 'Sixty-nine student responses were initiated, 14 of whom did not complete the full survey, leaving 55 students who were included in the final analysis']",['textbook group did not finish the educational activity'],"['knowledge acquisition', 'student satisfaction', 'Acetaminophen toxicity']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0013652', 'cui_str': 'Educational Activities'}]","[{'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",28.0,0.0336979,"A preference for watching a video over reading a textbook chapter was expressed by 78.4% of students, while 98% of students either agreed or strongly agreed with the statement that they would be comfortable using the internet to learn new concepts.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Vo', 'Affiliation': 'a Department of Emergency Medicine, Denver Health Medical Center , Denver , USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ledbetter', 'Affiliation': 'b Department of Biostatistics and Informatics, Colorado School of Public Health , Aurora , USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Zuckerman', 'Affiliation': 'c Department of Emergency Medicine, University of Colorado School of Medicine , Aurora , USA.'}]","Clinical toxicology (Philadelphia, Pa.)",['10.1080/15563650.2019.1574974']
1461,30791824,The Effect of Atosiban on Patients With Difficult Embryo Transfers Undergoing In Vitro Fertilization-Embryo Transfer.,"The purpose of this study was to evaluate the effect of atosiban on the outcomes of infertile women undergoing in vitro fertilization (IVF) with difficult embryo transfers (ETs). This randomized double-blind study enrolled 204 infertile women with difficult ETs during IVF treatment between June 2014 and June 2018. According to a computer-generated randomization list, participants were randomized into placebo (n = 102) and atosiban (n = 102) groups. In atosiban group, atosiban with a total dose of 37.5 mg was administered. All of the patients underwent IVF-ET using cryopreserved embryos. The clinical pregnancy rate per cycle and implantation rate per transfer (45.1% and 26.5%) in atosiban group were significantly higher than those of placebo group (15.6% and 9.7%, respectively; P < .05). This study showed that administration of atosiban during ET was extraordinarily effective for patients with difficult transfers.",2019,"The clinical pregnancy rate per cycle and implantation rate per transfer (45.1% and 26.5%) in atosiban group were significantly higher than those of placebo group (15.6% and 9.7%, respectively; P < .05).","['Patients With Difficult Embryo Transfers Undergoing', 'infertile women undergoing in vitro fertilization (IVF) with difficult embryo transfers (ETs', 'patients with difficult transfers', '204 infertile women with difficult ETs during IVF treatment between June 2014 and June 2018']","['atosiban', 'atosiban during ET', 'placebo', 'Atosiban']",['clinical pregnancy rate per cycle and implantation rate per transfer'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0164398', 'cui_str': 'Atosiban'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",204.0,0.318541,"The clinical pregnancy rate per cycle and implantation rate per transfer (45.1% and 26.5%) in atosiban group were significantly higher than those of placebo group (15.6% and 9.7%, respectively; P < .05).","[{'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': ""Department of Gynecology and Obstetrics, Qilu Hospital, Shandong University, Jinan, People's Republic of China.""}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ""Department of Reproductive Medicine, Shanxi Provincial People's Hospital, Taiyuan, People's Republic of China.""}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ""Department of Reproductive Medicine, Shanxi Provincial People's Hospital, Taiyuan, People's Republic of China.""}, {'ForeName': 'Shili', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': ""Department of Gynecology and Obstetrics, Qilu Hospital, Shandong University, Jinan, People's Republic of China.""}, {'ForeName': 'Baihua', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': ""Department of Gynecology and Obstetrics, Qilu Hospital, Shandong University, Jinan, People's Republic of China.""}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1177/1933719119831791']
1462,32407583,Proprioceptive neuromuscular facilitation improves pain and descending mechanics among elderly with knee osteoarthritis.,"PURPOSE
Knee osteoarthritis (KOA) is a common disease that causes pain and limits functionality in the elderly during daily activities, especially during stair descent. Proprioceptive neuromuscular facilitation (PNF) practices promote multiple-plane joint movements, which relieve pain and increase joint range of motion (ROM). This study aims to examine the effects of a 12-week PNF intervention on pain relief, passive and active joint ROM, external knee adduction moment (KAM), and hip adduction moment (HAM) in the elderly with KOA during stair descent.
MATERIALS AND METHODS
Seventy-six elderly who were diagnosed with KOA were assessed for eligibility and, 36 of them met the inclusive criteria, were randomly divided into two groups: the twelve-week PNF intervention group and the control group. Pain score was measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Passive joint ROM was measured using a goniometer. Active joint ROM, KAM, and HAM during stair descent were measured using a motion analysis system with a force platform. All the data were recorded at weeks 0, 6, and 12.
RESULTS
Compared to the control group, the PNF group showed a decreased pain score; increased passive hip, knee, and ankle ROM; a decreased minimum knee flexion angle, and increased HAM during stair descent.
PERSPECTIVE
Proprioceptive neuromuscular facilitation intervention is a successful method to relieve symptoms of KOA. It relieves pain without increasing KAM, enhances passive ROM, increases active knee flexion ROM, and increases HAM during stair descent in the elderly with KOA.",2020,"Compared to the control group, the PNF group showed a decreased pain score; increased passive hip, knee, and ankle ROM; a decreased minimum knee flexion angle, and increased HAM during stair descent.
","['Seventy-six elderly who were diagnosed with KOA were assessed for eligibility and, 36 of them met the inclusive criteria', 'elderly with KOA during stair descent', 'Elderly with Knee Osteoarthritis']","['Proprioceptive neuromuscular facilitation (PNF) practices', 'Proprioceptive neuromuscular facilitation', 'PNF', 'PNF intervention']","['minimum knee flexion angle, and increased HAM during stair descent', 'Pain score', 'Passive joint ROM', 'pain score; increased passive hip, knee, and ankle ROM', 'HAM', 'pain and increase joint range of motion (ROM', 'Active joint ROM, KAM, and HAM during stair descent', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC', 'pain relief, passive and active joint ROM, external knee adduction moment (KAM) and hip adduction moment (HAM', 'active knee flexion ROM']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205101', 'cui_str': 'External'}]",76.0,0.023522,"Compared to the control group, the PNF group showed a decreased pain score; increased passive hip, knee, and ankle ROM; a decreased minimum knee flexion angle, and increased HAM during stair descent.
","[{'ForeName': 'Qipeng', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': 'Shandong Sport University, Jinan, China.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Beijing Sport University, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Shandong Institute of Sport Science, Jinan, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Shandong Institute of Sport Science, Jinan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Georgia Southern University, Statesboro, GA, USA.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13709']
1463,30784637,"Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial.","BACKGROUND
Poor development in young children in developing countries is a major problem. Child development experts are calling for interventions that aim to improve child development to be integrated into health services, but there are few robust evaluations of such programmes. Previous small Bangladeshi trials that used individual play sessions with mothers and their children (at home or in clinics), which were predominantly run by employed women, found moderate improvements on child development. We aimed to integrate an early childhood development programme into government clinics that provide primary health care and to evaluate the effects of this intervention on child cognition, language, and motor development, growth, and behaviour in a subsample of the children.
METHODS
In this open-label cluster-randomised controlled trial, we recruited individuals from community clinics in Narsingdi district, Bangladesh. These clinics were randomly selected from a larger sample of eligible clinics, and they were assigned (1:1) to either deliver an intervention of 25 sessions, in which mothers of eligible children were shown how to support their child's development through play and interactions, or to deliver no intervention (control group). Participants were underweight children, defined as a weight-for-age Z score of -2 SDs of the WHO standard, who were aged 5-24 months and who lived near the clinic (defined as a walk of less than 30 min). Government health workers ran these sessions at the clinics as part of their routine work, and mothers and children attended fortnightly in pairs (instead of individual weekly home visits that were specified in the original programme). A subsample of children from each clinic was randomly selected for impact evaluation, and these children were assessed on the Bayley Scales of Infant and Toddler Development for their cognitive, language, and motor performance and for their behaviour with Wolke's ratings, before and after implementation of the intervention. The primary outcomes were the performance of this evaluation subsample on the Bayley and Wolke scales and their anthropometric measurements (weight, length or height, and head circumference) after 1 year of the intervention. This study is registered with ClinicalTrials.gov, number NCT02208531.
FINDINGS
Between Nov 29, 2014, and April 30, 2015, 12 054 children in 90 clinics were screened, and between six and 25 underweight children were enrolled from each clinic. From the 2423 (20%) underweight children, we excluded 656 (27%) children who lived more than 30-min walking distance from the community clinics, and 30 (1%) children whose mothers did not consent to participate. We therefore enrolled 1737 (72%) children from these 90 clinics. After randomisation, the control group clinics included 878 (51%) children (who all received no intervention) and the intervention group clinics included 859 (49%) children (who all received the child development programme sessions). Eight children from each clinic (360 [41%] children from the control group clinics and 358 [42%] children from the intervention group clinics) were randomly selected for inclusion in the evaluation subsample. Between Feb 24, 2016, and Sept 7, 2016, 344 (96%) children in control group clinics and 343 (96%) children in intervention group clinics were assessed for the primary outcome. 16 (5%) children in the control group clinics and 15 (4%) children in the intervention group clinics did not provide all data and were not included in final analyses. An intention-to-treat analysis showed that the intervention significantly improved children's cognition (effect size 1·3 SDs, 95% CI 1·1 to 1·5; p=0·006), language (1·1 SDs, 0·9 to 1·2; p=0·01), and motor composite scores (1·2 SDs, 1·0 to 1·3; p=0·006) and behaviour ratings (ranging from 0·7 SDs, 0·5 to 0·9; p=0·02; to 1·1 SDs, 1·0 to 1·2; p=0·007), but the intervention had no significant effect on growth (p values ranged from 0·05 to 0·74). Three (1%) children in the intervention group died, but their deaths were not related to the intervention.
INTERPRETATION
The extent and range of benefits of our intervention are encouraging. Health workers ran most of the sessions effectively and attendance was good, which is promising for scale-up of the intervention model. However, researchers trained and supervised the health workers, and the next step will be to determine whether the Bangladeshi ministry of health can perform these tasks. In future programmes, more attention needs to be paid to the nutrition of the children.
FUNDING
Grand Challenges Canada (Saving Brains).",2019,"An intention-to-treat analysis showed that the intervention significantly improved children's cognition (effect size 1·3 SDs, 95% CI 1·1 to 1·5; p=0·006), language (1·1 SDs, 0·9 to 1·2; p=0·01), and motor composite scores (1·2 SDs, 1·0 to 1·3; p=0·006) and behaviour ratings (ranging from 0·7 SDs, 0·5","['Between Nov 29, 2014, and April 30, 2015', 'mothers and their children (at home or in clinics', 'young children', 'From the 2423 (20%) underweight children, we excluded 656 (27%) children who lived more than 30-min walking distance from the community clinics, and 30 (1%) children whose mothers did not consent to participate', 'control group clinics included 878 (51%) children (who all received no intervention) and the intervention group clinics included 859 (49%) children (who all received the child development programme sessions', 'Eight children from each clinic (360 [41%] children from the control group clinics and 358 [42%] children from the intervention group clinics', 'recruited individuals from community clinics in Narsingdi district, Bangladesh', 'Participants were underweight children, defined as a weight-for-age Z score of -2 SDs of the WHO standard, who were aged 5-24 months and who lived near the clinic (defined as a walk of less than 30 min', 'enrolled 1737 (72%) children from these 90 clinics', ' 12\u2008054 children in 90 clinics were screened, and between six and 25 underweight children were enrolled from each clinic']","['early childhood development programme into Bangladeshi primary health-care services', ""support their child's development through play and interactions, or to deliver no intervention (control group""]","[""Bayley Scales of Infant and Toddler Development for their cognitive, language, and motor performance and for their behaviour with Wolke's ratings"", 'motor composite scores', 'behaviour ratings', 'performance of this evaluation subsample on the Bayley and Wolke scales and their anthropometric measurements (weight, length or height, and head circumference', ""children's cognition"", 'child cognition, language, and motor development, growth, and behaviour']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",8.0,0.0456209,"An intention-to-treat analysis showed that the intervention significantly improved children's cognition (effect size 1·3 SDs, 95% CI 1·1 to 1·5; p=0·006), language (1·1 SDs, 0·9 to 1·2; p=0·01), and motor composite scores (1·2 SDs, 1·0 to 1·3; p=0·006) and behaviour ratings (ranging from 0·7 SDs, 0·5","[{'ForeName': 'Jena D', 'Initials': 'JD', 'LastName': 'Hamadani', 'Affiliation': 'Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh. Electronic address: jena@icddrb.org.'}, {'ForeName': 'Syeda F', 'Initials': 'SF', 'LastName': 'Mehrin', 'Affiliation': 'Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Tofail', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad I', 'Initials': 'MI', 'LastName': 'Hasan', 'Affiliation': 'Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Syed N', 'Initials': 'SN', 'LastName': 'Huda', 'Affiliation': 'Toronto, ON, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Baker-Henningham', 'Affiliation': 'School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ridout', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30535-7']
1464,30784638,Household contact investigation for the detection of tuberculosis in Vietnam: economic evaluation of a cluster-randomised trial.,"BACKGROUND
Active case finding is recommended as an important strategy to control tuberculosis, particularly in low-income and middle-income countries with a high prevalence of the disease. However, the costs and cost-effectiveness of active case finding are unclear due to the absence of evidence from randomised trials. We assessed the costs and cost-effectiveness of an active case finding strategy in Vietnam, where there is a high prevalence of tuberculosis.
METHODS
We conducted an economic evaluation alongside the Active Case Finding in Tuberculosis (ACT2) trial-a pragmatic cluster-randomised controlled trial in 70 districts across eight provinces of Vietnam. Patients aged 15 years and older with smear-positive pulmonary tuberculosis were recruited to the trial if they lived with one or more other household members. Household contacts were verbally invited to the clinic by the index patient with tuberculosis. ACT2 compared a combination of active and passive case finding with usual care (passive case finding) of household contacts of patients with tuberculosis from a health system perspective. Clustering occurred at the district and household level. Districts were the unit of randomisation, and we used minimisation to ensure balance of intervention and control districts within each province. In the intervention group, participants were invited to attend screening at baseline, 6 months, 12 months, and 24 months. We determined health-care costs with a standardised national costing survey and reported results in 2017 $US. The primary outcome of our study was disability-adjusted life years (DALYs) averted over a 24-month period. ACT2 was registered prospectively with the Australian and New Zealand Clinical Trials Registry, number ACTRN126.100.00600044.
FINDINGS
Between Aug 11, 2010, and Aug 11, 2015, 10 964 index patients and 25 707 household contacts completed the ACT2 study. There were 10 069 household contacts in the intervention group and 15 638 household contacts in the control group. The incremental cost-effectiveness ratio per DALY averted was $544 (330-1375).
INTERPRETATION
Active case finding was shown to be highly cost-effective in a setting with a high prevalence of tuberculosis. Investment in the wide-scale implementation of this programme in Vietnam should be strongly supported.
FUNDING
Australian National Health and Medical Research Council.",2019,"The incremental cost-effectiveness ratio per DALY averted was $544 (330-1375).
","['patients with tuberculosis from a health system perspective', 'Between Aug 11, 2010, and Aug 11, 2015, 10\u2008964 index patients and 25\u2008707 household contacts', '70 districts across eight provinces of Vietnam', 'Patients aged 15 years and older with smear-positive pulmonary tuberculosis were recruited to the trial if they lived with one or more other household members', 'There were 10\u2008069 household contacts in the intervention group and 15\u2008638 household contacts in the control group']",['ACT2'],"['costs and cost-effectiveness', 'incremental cost-effectiveness ratio per DALY averted', 'disability-adjusted life years (DALYs) averted over a 24-month period']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0282620', 'cui_str': 'Adjusted Life Years'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.343951,"The incremental cost-effectiveness ratio per DALY averted was $544 (330-1375).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, NSW, Australia. Electronic address: tlung@georgeinstitute.org.au.'}, {'ForeName': 'Guy B', 'Initials': 'GB', 'LastName': 'Marks', 'Affiliation': 'South Western Sydney Clinical School, University of New South Wales, Kensington, NSW, Australia; Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Nguyen Viet', 'Initials': 'NV', 'LastName': 'Nhung', 'Affiliation': 'National Lung Hospital, Ba Dinh, Hanoi, Vietnam; Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Thu', 'Initials': 'NT', 'LastName': 'Anh', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Nghiem Le Phuong', 'Initials': 'NLP', 'LastName': 'Hoa', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Le Thi Ngoc', 'Initials': 'LTN', 'LastName': 'Anh', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Nguyen Binh', 'Initials': 'NB', 'LastName': 'Hoa', 'Affiliation': 'National Lung Hospital, Ba Dinh, Hanoi, Vietnam; Centre for Operational Research, International Union Against Tuberculosis and Lung Disease, Paris, France.'}, {'ForeName': 'Warwick John', 'Initials': 'WJ', 'LastName': 'Britton', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, NSW, Australia; Centenary Institute of Cancer Medicine and Cell Biology, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bestrashniy', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, NSW, Australia; Faculty of Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Fox', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, NSW, Australia; Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30520-5']
1465,31702397,Tele-rehabilitation and hospital-based cardiac rehabilitation are comparable in increasing patient activation and health literacy: A pilot study.,"BACKGROUND
Cardiac tele-rehabilitation is defined as using information and communication technology to support rehabilitation services. However, it requires a high level of patient activation and health literacy; this has not yet been explored.
AIMS
The purpose of this study was to evaluate patient activation and health literacy in tele-rehabilitation compared to hospital-based cardiac rehabilitation.
METHODS
We conducted a pilot study in patients with ischaemic or heart valve disease. In a non-randomised design, 24 patients attended a 12-week tele-rehabilitation programme, and 53 matched controls a 12-week hospital-based cardiac rehabilitation programme. The primary outcome was patient activation, which was assessed using the Patient Activation Measure before the intervention, at the end of the intervention and at follow-up six months after the intervention. The secondary outcome was health literacy, assessed using three dimensions from the Health Literacy Questionnaire before rehabilitation and at six-month follow-up: actively manage my health (HLQ3), ability to engage with healthcare providers (HLQ6) and understanding health information (HLQ9).
RESULTS
Patient activation improved similarly in tele-rehabilitation and hospital-based cardiac rehabilitation at all time points. Six months after the intervention, patients in tele-rehabilitation significantly improved on the dimension HLQ6 compared to patients in hospital-based cardiac rehabilitation. No significant between-group differences were found in HLQ3 or HLQ9.
CONCLUSION
Tele-rehabilitation and hospital-based cardiac rehabilitation seemed to be equally successful in improving patient activation and health literacy. Tele-rehabilitation should be further tested in a randomised controlled trial, with a focus on whether patient levels of education and self-management at the initiation of rehabilitation are decisive factors for tele-rehabilitation participation.",2020,"Six months after the intervention, patients in tele-rehabilitation significantly improved on the dimension HLQ6 compared to patients in hospital-based cardiac rehabilitation.","['patients with ischaemic or heart valve disease', '24 patients attended a 12-week tele-rehabilitation programme, and 53 matched controls a 12-week hospital-based cardiac rehabilitation programme', 'patient activation and health literacy']",[],"['dimension HLQ6', 'patient activation', 'tele-rehabilitation and hospital-based cardiac rehabilitation', 'patient activation and health literacy', 'health literacy, assessed using three dimensions from the Health Literacy Questionnaire before rehabilitation and at six-month follow-up: actively manage my health (HLQ3), ability to engage with healthcare providers (HLQ6) and understanding health information (HLQ9', 'HLQ3 or HLQ9']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0018824', 'cui_str': 'Valvular Heart Diseases'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",[],"[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0235341,"Six months after the intervention, patients in tele-rehabilitation significantly improved on the dimension HLQ6 compared to patients in hospital-based cardiac rehabilitation.","[{'ForeName': 'Marie V', 'Initials': 'MV', 'LastName': 'Knudsen', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Annemette K', 'Initials': 'AK', 'LastName': 'Petersen', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Angel', 'Affiliation': 'Nursing and Health Care, Aarhus University, Denmark.'}, {'ForeName': 'Vibeke E', 'Initials': 'VE', 'LastName': 'Hjortdal', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Helle T', 'Initials': 'HT', 'LastName': 'Maindal', 'Affiliation': 'Health Promotion and Population Health, Aarhus University, Denmark.'}, {'ForeName': 'Sussie', 'Initials': 'S', 'LastName': 'Laustsen', 'Affiliation': 'Centre of Research in Rehabilitation, Aarhus University, Denmark.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119885325']
1466,31697573,"The effect of the artificial sweeteners on glucose metabolism in healthy adults: a randomized, double-blinded, crossover clinical trial.","This study aimed to determine the effect of pure forms of sucralose and aspartame, in doses reflective of common consumption, on glucose metabolism. Healthy participants consumed pure forms of a non-nutritive sweetener (NNS) that were mixed with water and standardized to doses of 14% (0.425 g) of the acceptable daily intake (ADI) for aspartame and 20% (0.136 g) of the ADI for sucralose every day for 2 weeks. Blood samples were collected and analyzed for glucose, insulin, active glucagon-like peptide-1 (GLP-1), and leptin. Seventeen participants (10 females and 7 males; age, 24 ± 6.8 years; body mass index, 22.9 ± 2.5 kg/m 2 ) participated in the study. The total area under the curve values of glucose, insulin, active GLP-1 and leptin were similar for the aspartame and sucralose treatment groups compared with the baseline values in healthy participants. There was no change in insulin sensitivity after NNS treatment compared with the baseline values. These findings suggest that daily repeated consumption of pure sucralose or aspartame for 2 weeks had no effect on glucose metabolism among normoglycaemic adults. However, these results need to be tested in studies with longer durations. Novelty Daily consumption of pure aspartame or sucralose for 2 weeks had no effect on glucose metabolism. Daily consumption of pure aspartame or sucralose for 2 weeks had no effect on insulin sensitivity among healthy adults.",2020,"The total area under the curve (AUC) values of glucose, insulin, active GLP-1 and leptin were similar for the aspartame and sucralose treatment groups compared to the baseline values in healthy participants.","['normoglycaemic adults', 'Healthy participants consumed pure forms of a non-nutritive sweetener (NNS) mixed with water that were standardized to doses of 14% (0.425 g) of the', 'Seventeen participants (10 females and 7 males; age 24 ± 6.8 years; BMI 22.9 ± 2.5 kg/m2) participated in the study', 'healthy participants', 'healthy adults']","['pure aspartame or sucralose', 'acceptable daily intake (ADI) for aspartame', 'pure sucralose or aspartame', 'sucralose and aspartame', 'artificial sweeteners']","['insulin sensitivity', 'total area under the curve (AUC) values of glucose, insulin, active GLP-1 and leptin', 'Novelty', 'glucose metabolism', 'glucose, insulin, active glucagon-like peptide-1 (GLP-1), and leptin']","[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3658246', 'cui_str': 'High-Intensity Sweeteners'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C3658296', 'cui_str': 'Tolerable Daily Intake'}, {'cui': 'C0003920', 'cui_str': 'Artificial Sweeteners'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",17.0,0.403176,"The total area under the curve (AUC) values of glucose, insulin, active GLP-1 and leptin were similar for the aspartame and sucralose treatment groups compared to the baseline values in healthy participants.","[{'ForeName': 'Samar Y', 'Initials': 'SY', 'LastName': 'Ahmad', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Richardson Centre for Functional Foods and Nutraceuticals, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB R3T 6C5, Canada.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Friel', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Richardson Centre for Functional Foods and Nutraceuticals, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB R3T 6C5, Canada.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'MacKay', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Richardson Centre for Functional Foods and Nutraceuticals, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB R3T 6C5, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0359']
1467,30762895,Lusutrombopag for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Invasive Procedures (L-PLUS 2).,"Thrombocytopenia may be associated with increased bleeding risk impacting timing and outcome of invasive procedures in patients with chronic liver disease (CLD). Lusutrombopag, a small-molecule, thrombopoietin (TPO) receptor agonist, was evaluated as a treatment to raise platelet counts (PCs) in patients with thrombocytopenia and CLD undergoing invasive procedures. L-PLUS 2 was a global, phase 3, randomized, double-blind, placebo-controlled study. Adults with CLD and baseline PCs < 50 × 10 9 /L were randomized to receive once-daily lusutrombopag 3 mg or placebo ≤ 7 days before an invasive procedure scheduled 2-7 days after the last dose. The primary endpoint was avoidance of preprocedure platelet transfusion and avoidance of rescue therapy for bleeding. A key secondary endpoint was number of days PCs were ≥ 50 × 10 9 /L throughout the study. Safety analysis was performed on patients who received at least one dose of study drug. This study occurred between June 15, 2015, and April 19, 2017, with a total of 215 randomized patients (lusutrombopag, 108; placebo, 107); 64.8% (70/108) of patients in the lusutrombopag group versus 29.0% (31/107) in the placebo group met the primary endpoint (P < 0.0001; difference of proportion 95% confidence interval [CI], 36.7 [24.9, 48.5]). The median duration of PCs ≥ 50 × 10 9 /L was 19.2 days with lusutrombopag (without platelet transfusion) compared with 0.0 in the placebo group (with platelet transfusion) (P = 0.0001). Most adverse events were mild or moderate in severity, and rates were similar in the lusutrombopag and placebo groups (47.7% and 48.6%, respectively). Conclusion: Lusutrombopag was superior to placebo for reducing the need for platelet transfusions and achieved durable PC response in patients with thrombocytopenia and CLD undergoing invasive procedures, with a safety profile similar to placebo.",2019,"Lusutrombopag was superior to placebo for reducing the need for platelet transfusions and achieved durable PC response in patients with thrombocytopenia and CLD undergoing invasive procedures, with a safety profile similar to placebo.","['patients with thrombocytopenia and CLD undergoing invasive procedures', 'Patients With Chronic Liver Disease Undergoing Invasive Procedures (L-PLUS 2', 'June 15, 2015, and April 19, 2017, with a total of 215 randomized patients (lusutrombopag, 108; placebo, 107); 64.8% (70/108) of patients in the lusutrombopag group versus 29.0% (31/107) in the', 'Adults with CLD and baseline PCs < 50 × 10 9 /L', 'patients with chronic liver disease (CLD']","['Lusutrombopag', 'lusutrombopag 3 mg or placebo', 'placebo']","['median duration of PCs', 'avoidance of preprocedure platelet transfusion and avoidance of rescue therapy for bleeding', 'number of days PCs were\xa0≥', 'durable PC response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0055926', 'cui_str': 'endogenous clonidine-like substance'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C4309207', 'cui_str': 'lusutrombopag'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4309207', 'cui_str': 'lusutrombopag'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",215.0,0.721738,"Lusutrombopag was superior to placebo for reducing the need for platelet transfusions and achieved durable PC response in patients with thrombocytopenia and CLD undergoing invasive procedures, with a safety profile similar to placebo.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Peck-Radosavljevic', 'Affiliation': 'Abteilung Innere Medizin & Gastroenterologie, mit Zentraler Aufnahme & Erstversorgung, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Simon', 'Affiliation': 'Department of Infectious Diseases and Hepatology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Iacobellis', 'Affiliation': 'Division of Gastroenterology, Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Hassanein', 'Affiliation': 'Southern California Research Center, Coronado, CA.'}, {'ForeName': 'Zeid', 'Initials': 'Z', 'LastName': 'Kayali', 'Affiliation': 'Inland Empire Liver Foundation, University of California, Riverside, Rialto, CA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'Institut national de la santé et la recherche médicale (INSERM), Unit 1065, Centre Méditerranéen de Médecine Moléculaire (C3M), Team 8: ""Chronic liver diseases associated with obesity and alcohol"", Nice, France.'}, {'ForeName': 'Mihaly', 'Initials': 'M', 'LastName': 'Makara', 'Affiliation': 'Dél-pesti Centrumkórház-Országos Hematológiai és Infektológiai Intézet, Budapest, Hungary.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Ben Ari', 'Affiliation': 'Liver Disease Center, Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Braun', 'Affiliation': 'Department of Gastroenterology, Rabin Medical Center Belinson Campus, Petah-Tikva, Israel.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mitrut', 'Affiliation': 'Spitalul Clinic Judetean de Urgenta Craiova, Craiova, Romania.'}, {'ForeName': 'Sheng-Shun', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Division of Gastroenterology & Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Akdogan', 'Affiliation': 'Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Pirisi', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Duggal', 'Affiliation': 'Shionogi Ltd., Holborn, London, United Kingdom.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Ochiai', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Motomiya', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Tsutae', 'Initials': 'T', 'LastName': 'Nagata', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Nezam', 'Initials': 'N', 'LastName': 'Afdhal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30561']
1468,31701891,"Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial.","BACKGROUND
Chronic cluster headache is the most disabling form of cluster headache. The mainstay of treatment is attack prevention, but the available management options have little efficacy and are associated with substantial side-effects. In this study, we aimed to assess the safety and efficacy of sphenopalatine ganglion stimulation for treatment of chronic cluster headache.
METHODS
We did a randomised, sham-controlled, parallel group, double-blind, safety and efficacy study at 21 headache centres in the USA. We recruited patients aged 22 years or older with chronic cluster headache, who reported a minimum of four cluster headache attacks per week that were unsuccessfully controlled by preventive treatments. Participants were randomly assigned (1:1) via an online adaptive randomisation procedure to either stimulation of the sphenopalatine ganglion or a sham control that delivered a cutaneous electrical stimulation. Patients and the clinical evaluator and surgeon were masked to group assignment. The primary efficacy endpoint, which was analysed with weighted generalised estimated equation logistic regression models, was the difference between groups in the proportion of stimulation-treated ipsilateral cluster attacks for which relief from pain was achieved 15 min after the start of stimulation without the use of acute drugs before that timepoint. Efficacy analyses were done in all patients who were implanted with a device and provided data for at least one treated attack during the 4-week experimental phase. Safety was assessed in all patients undergoing an implantation procedure up to the end of the open-label phase of the study, which followed the experimental phase. This trial is registered with ClinicalTrials.gov, number NCT02168764.
FINDINGS
Between July 9, 2014, and Feb 14, 2017, 93 patients were enrolled and randomly assigned, 45 to the sphenopalatine ganglion stimulation group and 48 to the control group. 36 patients in the sphenopalatine ganglion stimulation group and 40 in the control group had at least one attack during the experimental phase and were included in efficacy analyses. The proportion of attacks for which pain relief was experienced at 15 min was 62·46% (95% CI 49·15-74·12) in the sphenopalatine ganglion stimulation group versus 38·87% (28·60-50·25) in the control group (odds ratio 2·62 [95% CI 1·28-5·34]; p=0·008). Nine serious adverse events were reported by the end of the open-label phase. Three of these serious adverse events were related to the implantation procedure (aspiration during intubation, nausea and vomiting, and venous injury or compromise). A fourth serious adverse event was an infection that was attributed to both the stimulation device and the implantation procedure. The other five serious adverse events were unrelated. There were no unanticipated serious adverse events.
INTERPRETATION
Sphenopalatine ganglion stimulation seems efficacious and is well tolerated, and potentially offers an alternative approach to the treatment of chronic cluster headache. Further research is need to clarify its place in clinical practice.
FUNDING
Autonomic Technologies.",2019,36 patients in the sphenopalatine ganglion stimulation group and 40 in the control group had at least one attack during the experimental phase and were included in efficacy analyses.,"['Between July 9, 2014, and Feb 14, 2017, 93 patients were enrolled and randomly assigned, 45 to the', 'chronic cluster headache', '21 headache centres in the USA', 'patients aged 22 years or older with chronic cluster headache, who reported a minimum of four cluster headache attacks per week that were unsuccessfully controlled by preventive treatments', '36 patients in the']","['sphenopalatine ganglion stimulation', 'online adaptive randomisation procedure to either stimulation of the sphenopalatine ganglion or a sham control that delivered a cutaneous electrical stimulation']","['Safety', 'Safety and efficacy', 'nausea and vomiting, and venous injury or compromise', 'Nine serious adverse events', 'proportion of stimulation-treated ipsilateral cluster attacks for which relief from pain', 'safety and efficacy', 'proportion of attacks for which pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009088', 'cui_str': 'Neuralgic Migraine'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0229062', 'cui_str': 'Pterygopalatine Ganglia'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0340770', 'cui_str': 'Injury of vein (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",93.0,0.241285,36 patients in the sphenopalatine ganglion stimulation group and 40 in the control group had at least one attack during the experimental phase and were included in efficacy analyses.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""National Institute for Health Research-Wellcome Trust King's Clinical Research Facility and South London and the Maudsley Biomedical Research Centre, King's College London, London, UK. Electronic address: peter.goadsby@kcl.ac.uk.""}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Sahai-Srivastava', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Kezirian', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Calhoun', 'Affiliation': 'Carolina Headache Institute, Durham, NC, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Matthews', 'Affiliation': 'Carolinas HealthCare System, Charlotte, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McAllister', 'Affiliation': 'New England Institute for Neurology and Headache, Stamford, CT, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Costantino', 'Affiliation': 'New York Head and Neck Institute, Northwell Health System, New York, NY, USA.'}, {'ForeName': 'Deborah I', 'Initials': 'DI', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA; Headache and Facial Pain Program, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Zuniga', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Laszlo L', 'Initials': 'LL', 'LastName': 'Mechtler', 'Affiliation': 'Dent Headache Center, Dent Neurologic Institute, Buffalo, NY, USA.'}, {'ForeName': 'Saurin R', 'Initials': 'SR', 'LastName': 'Popat', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Ali R', 'Initials': 'AR', 'LastName': 'Rezai', 'Affiliation': 'Rockefeller Neuroscience Institute, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30322-9']
1469,30702059,Extended-release naltrexone versus standard oral naltrexone versus placebo for opioid use disorder: the NEAT three-arm RCT.,"BACKGROUND
People recovering from heroin addiction need better treatments than are currently offered. The chronic relapsing nature of drug dependence means that helping a patient to achieve abstinence is often difficult. Naltrexone blocks the effects of ingested heroin; however, evidence is conflicting regarding the best delivery method.
OBJECTIVES
The primary purpose of the trial was to evaluate the clinical effectiveness and cost-effectiveness of extended-release naltrexone versus standard oral naltrexone versus relapse prevention therapy without medication for opioid use disorder (OUD).
DESIGN
This was a 3-year, definitive, three-centre, three-arm, parallel group, placebo-controlled, double-blind, double-dummy, randomised controlled trial.
SETTING
Two specialist NHS outpatient addiction clinics: one in London and one in Birmingham.
PARTICIPANTS
Planned study sample - 300 adult patients with OUD who had completed detoxification.
INTERVENTIONS
One iGen/Atral-Cipan Extended Release Naltrexone device (iGen/Atral-Cipan, Castanheira do Ribatejo, Portugal) (765 mg naltrexone or placebo) at day 0 of study week 1. Three weekly directly observed active or placebo oral naltrexone tablets (2 × 50 mg, Monday and Wednesday; 3 × 50 mg, Friday) at day 0 of study week 1 (for 4 weeks) and then an 8-week regimen of patient-administered dosing at the same dosing level.
MAIN OUTCOME MEASURE
The primary outcome measure was the proportion of heroin-negative urine drug screen (UDS) results at the end of the 12-week post-randomisation time point.
RESULTS
Six patients were recruited and randomised to receive study interventions. Two patients had no positive UDS samples for heroin during the 12-week treatment period, one patient had only one positive UDS sample and the remaining patients had two, six and eight positive UDS results for heroin. All patients had at least one missed clinic visit (range 1-14).
CONCLUSIONS
Considerable problems were encountered with (1) the stipulated requirement of a validated 'detoxified' status prior to the initiation of the study naltrexone, (2) the requirement for a consent cooling-off period and (3) delays awaiting the surgical implant procedure. Major upheaval to the organisation and delivery of NHS community treatment services across England led to extremely poor levels of actual entry of patients into the trial. Research-vital clinical and procedural requirements were, therefore, more challenging to implement. The potential therapeutic value of the opioid antagonist naltrexone still needs clear investigation, including comparison of the established oral form with the new ultra-long-acting depot implant formulations (for which no licensed products exist in Europe). Despite the small number of study participants, some tentative conclusions can be reached, relevant to potential future work. The blinding of the active/placebo medications appeared to be good. Self-report was not sufficient to detect instances of heroin use. Self-report plus UDS information provided a fuller picture. Instances of lapsed heroin use were not necessarily followed by full relapse, and future work should consider the lapse-relapse relationship. The prison release setting also warrants special consideration. In future, investigators should consider seeking ethics approval for studies in which clinical procedures to accelerate the treatment process are permitted, even if outside orthodox clinical practice, if they address a clinical need at the time of challenge and clinical risk. In addition, it may be appropriate to seek exemption from the ordinary requirement of a cooling-off period after securing consent because it is often essential to initiate treatment promptly.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN95809946.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 3. See the NIHR Journals Library website for further project information.",2019,Major upheaval to the organisation and delivery of NHS community treatment services across England led to extremely poor levels of actual entry of patients into the trial.,"['Six patients', 'Two specialist NHS outpatient addiction clinics', 'All patients had at least one missed clinic visit (range 1-14', 'Planned study sample - 300 adult patients with OUD who had completed detoxification']","['naltrexone versus placebo', 'placebo', 'placebo oral naltrexone tablets', 'naltrexone', 'naltrexone or placebo', 'opioid antagonist naltrexone', 'extended-release naltrexone', 'Naltrexone']","['clinical effectiveness and cost-effectiveness', 'proportion of heroin-negative urine drug screen (UDS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0150543', 'cui_str': 'Detoxification therapy (regime/therapy)'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",300.0,0.160252,Major upheaval to the organisation and delivery of NHS community treatment services across England led to extremely poor levels of actual entry of patients into the trial.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kelleher', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Lambeth Addictions Consortium, London, UK.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Mayet', 'Affiliation': 'Specialist Care Group (Addictions), Humber NHS Foundation Trust, Wolverhampton, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hellier', 'Affiliation': ""Biostatistics and Health Informatics Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': ""King's Clinical Trials Unit, King's College London, London, UK.""}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'McLennan', 'Affiliation': ""King's Clinical Trials Unit, King's College London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': ""Biostatistics and Health Informatics Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23030']
1470,30444856,The impact of hypothermia on outcomes in massively transfused patients.,"BACKGROUND
Hypothermia is associated with poor outcomes after injury. The relationship between hypothermia during contemporary large volume resuscitation and blood product consumption is unknown. We evaluated this association, and the predictive value of hypothermia on mortality.
METHODS
Patients predicted to receive massive transfusion at 12 level 1 trauma centers were randomized in the Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial and were grouped into those who were hypothermic (<36°C) or normothermic (36-38.5°C) within the first 6 hours of emergency department arrival. The impact of hypothermia or normothermia on the volume of blood product required during the first 24 hours was determined via negative binomial regression, adjusting for treatment arm, injury severity score, mechanism, demographics, pre-emergency department fluid volume, blood administered before becoming hypothermic, pulse and systolic blood pressure on arrival, and the time exposed to hypothermic or normothermic temperatures.
RESULTS
Of 680 patients, 590 had a temperature measured during the first 6 hours in hospital, and 399 experienced hypothermia. The mean number of red blood cell (RBC) units given to all patients in the first 24 hours of admission was 8.8 (95% confidence interval [CI], 7.9-9.6). In multivariable analysis, every 1°C decrease in temperature below 36.0°C was associated with a 10% increase (incidence rate ratio, 0.90; 95% CI, 0.89-0.92; p < 0.00) in consumption of RBCs during the first 24 hours of admission. There was no association between RBC administration and a temperature above 36°C. Hypothermia on arrival was an independent predictor of mortality, with an adjusted odds ratio of 2.7 (95% CI, 1.7-4.5; p < 0.00) for 24-hour mortality and 1.8 (95% CI, 1.3-2.4; p < 0.00) for 30-day mortality.
CONCLUSION
Hypothermia is associated with increase in blood product consumption and mortality. These findings support the maintenance of normothermia in trauma patients and suggest that further investigation on the impact of cooling or rewarming during massive transfusion is warranted.
LEVEL OF EVIDENCE
Prognostic, level III.",2019,"Hypothermia on arrival was an independent predictor of mortality, with an adjusted odds ratio of 2.7 (95% CI, 1.7-4.5; p < 0.00) for 24-hour mortality and 1.8 (95% CI, 1.3-2.4; p < 0.00) for 30-day mortality.
","['Patients predicted to receive massive transfusion at 12 level 1 trauma centers', 'trauma patients', 'massively transfused patients', '680 patients']",['hypothermia or normothermia'],"['30-day mortality', 'mean number of red blood cell (RBC) units', 'consumption of RBCs', 'injury severity score, mechanism, demographics, pre-emergency department fluid volume, blood administered before becoming hypothermic, pulse and systolic blood pressure on arrival, and the time exposed to hypothermic or normothermic temperatures', '24-hour mortality', 'blood product consumption and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021504', 'cui_str': 'ISS Score'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}]",680.0,0.0743858,"Hypothermia on arrival was an independent predictor of mortality, with an adjusted odds ratio of 2.7 (95% CI, 1.7-4.5; p < 0.00) for 24-hour mortality and 1.8 (95% CI, 1.3-2.4; p < 0.00) for 30-day mortality.
","[{'ForeName': 'Erica Louise Walsh', 'Initials': 'ELW', 'LastName': 'Lester', 'Affiliation': ""From the Division of General Surgery (E.L.W.L.), Department of Surgery, University of Alberta, Edmonton, Alberta, Canada; Center for Translational Injury Research (E.E.F., J.H.), Division of Acute Care Surgery, Department of Surgery, Medical School, University of Texas Health Science Center, Houston, Texas; Division of Trauma (K.B.), Critical Care and Acute Care Surgery, School of Medicine, Oregon Health and Science University, Portland, Oregon; Division of Trauma and Critical Care (E.M.B.), Department of Surgery, School of Medicine, University of Washington, Seattle, Washington; Department of Surgery (M.C.), University of Colorado, Denver, Colorado; Center for Translational Injury Research (B.A.C.), Division of Acute Care Surgery, Department of Surgery, Medical School, University of Texas Health Science Center, Houston, Texas; Division of Trauma and Surgical Critical Care (T.C.T.C.F.), Department of Surgery, College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee; Division of Trauma (J.D.K.), Burns and Surgical Critical Care, Department of Surgery, School of Medicine, University of Alabama, Birmingham, Alabama; Division of Trauma (T.O.), Critical Care and Emergency Surgery, Department of Surgery, University of Arizona, Tucson, Arizona; Trauma and Acute Care Service (S.B.R.), St. Michael's Hospital, Toronto, Ontario, Canada; R Adams Crowley Shock Trauma Center (T.S.), University of Maryland, Baltimore, Maryland; Division of Trauma (M.A.S.), Critical Care and Acute Care Surgery, Department of Surgery, Oregon Health and Science University, Portland, Oregon; and Division of Trauma and Critical Care (K.I.), LAC+USC Medical Center, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Brasel', 'Affiliation': ''}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Bulger', 'Affiliation': ''}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Cotton', 'Affiliation': ''}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Fabian', 'Affiliation': ''}, {'ForeName': 'Jeffery D', 'Initials': 'JD', 'LastName': 'Kerby', 'Affiliation': ''}, {'ForeName': 'Terrence', 'Initials': 'T', 'LastName': 'OʼKeefe', 'Affiliation': ''}, {'ForeName': 'Sandro B', 'Initials': 'SB', 'LastName': 'Rizoli', 'Affiliation': ''}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Scalea', 'Affiliation': ''}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Inaba', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002144']
1471,30636672,The Effectiveness of Leech Therapy in Chronic Low Back Pain.,"BACKGROUND
Leech therapy has been found to be effective in the treatment of a number of chronic musculoskeletal pain syndromes. Leeches are also often used empirically to treat chronic low back pain, but data from clinical trials have been lacking to date. We therefore conducted the first randomized trial of leech therapy for chronic low back pain.
METHODS
Patients with chronic low back pain were randomized to receive either a single session of local treatment with 4-7 leeches or four weekly sessions of exercise therapy (1 hour each) led by a physical therapist. The primary endpoint was a change in average back pain intensity, as measured using a 100-mm visual analog scale (VAS), after 28 days. Secondary end- points included functional impairment (Roland-Morris Disability Questionnaire, Hannover Functional Ability Questionnaire), quality of life (Short-Form Health Questionnaire [SF 36]), pain perception (pain perception scale = Schmerzempfindungsskala [SES]), depressivity (Center for Epidemiological Studies Depression Scale [CES-D]), and analgesic consumption (questionnaire/ diary). Trial visits took place before treatment and on days 28 ± 3 and 56 ± 5 after the start of treatment; the overall duration of the trial was 56 ± 5 days.
RESULTS
The mean low back pain score improved from 61.2 ± 15.6 before treatment to 33.1 ± 22.4 on day 28 in the leech ther- apy group (n = 25) and from 61.6 ± 14.8 to 59.8 ± 16.7 in the exercise therapy group (n = 19) (group difference -25.2; 95% con- fidence interval [-41.0; -9.45]; p = 0.0018). Significant benefits of leech therapy were also found at both time points with respect to physical impairment and function as well as physical quality of life. The patients' expectations from treatment were higher in the leech therapy group but did not significantly affect the findings.
CONCLUSION
A single session of leech therapy is more effective over the short term in lowering the intensity of pain over the short term and in improving physical function and quality of life over the intermediate term (4 weeks and 8 weeks, respectively). The limitations of this trial are the lack of blinding and the small number of patients. Leech therapy appears to be an effective treat- ment for chronic low back pain.",2018,Significant benefits of leech therapy were also found at both time points with respect to physical impairment and function as well as physical quality of life.,"['Patients with chronic low back pain', 'Chronic Low Back Pain', 'chronic low back pain']","['local treatment with 4-7 leeches or four weekly sessions of exercise therapy (1 hour each) led by a physical therapist', 'leech therapy', 'Leech therapy', 'Leech Therapy']","['physical quality of life', 'change in average back pain intensity, as measured using a 100-mm visual analog scale (VAS', 'mean low back pain score', 'physical function and quality of life', 'functional impairment (Roland-Morris Disability Questionnaire, Hannover Functional Ability Questionnaire), quality of life (Short-Form Health Questionnaire [SF 36]), pain perception (pain perception scale = Schmerzempfindungsskala [SES]), depressivity (Center for Epidemiological Studies Depression Scale [CES-D]), and analgesic consumption (questionnaire/ diary']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0579183', 'cui_str': 'Hirudo (organism)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0262711', 'cui_str': 'Leech Therapy'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0222045'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",,0.130296,Significant benefits of leech therapy were also found at both time points with respect to physical impairment and function as well as physical quality of life.,"[{'ForeName': 'Christoph-Daniel', 'Initials': 'CD', 'LastName': 'Hohmann', 'Affiliation': 'Charité - University Medicine Berlin, corporate member of the Free University Berlin, Humboldt University of Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Foundation Chair of Clinical Naturopathy; Department of Internal Medicine, Division of Naturopathy, Immanuel Hospital Berlin; Department of Psychology, Faculty of Health, Witten/Herdecke University; KPW Garbsen, Center for Physiotherapy.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stange', 'Affiliation': ''}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Steckhan', 'Affiliation': ''}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Robens', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ostermann', 'Affiliation': ''}, {'ForeName': 'Arion', 'Initials': 'A', 'LastName': 'Paetow', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michalsen', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2018.0785']
1472,31627908,No Advantage of Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene-Covered Stents over Uncovered Nitinol Stents for Percutaneous Palliation of Malignant Infrahilar Biliary Obstruction: Results of a Single-Center Prospective Randomized Trial.,"PURPOSE
To prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction.
MATERIALS AND METHODS
After failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene-covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared.
RESULTS
Three patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178-438 d) for covered and 442 d (95% CI, 172-712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68-124 d) with covered stents and 75 days (95% CI, 42-108 d) with uncovered stents (P = .6).
CONCLUSIONS
In malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.",2020,"At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001).","['154 patients with obstructive jaundice caused by unresectable infrahilar malignancy', 'Malignant Infrahilar Biliary Obstruction']","['Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene-Covered Stents', 'expanded polytetrafluoroethylene and fluorinated ethylene propylene-covered or an uncovered nitinol stent', 'Nitinol Stents', 'palliative chemotherapy']","['Occlusion rate, patency, and survival', 'Estimated median survival times', 'patency or survival', 'Estimated median patency durations', 'Safety and clinical success', 'median bilirubin reduction', 'Serious adverse events', '30-day mortality', 'Occlusion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0382943', 'cui_str': 'poly(tetrafluoroethylene-co-hexafluoropropylene)'}, {'cui': 'C1322797', 'cui_str': 'Covered Stent'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",154.0,0.269582,"At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001).","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: elisabeth.dhondt@uzgent.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanlangenhove', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Man', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Huyck', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defreyne', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.07.013']
1473,31702699,"Effect of Oral Carbohydrate Intake During Labor on the Rate of Instrumental Vaginal Delivery: A Multicenter, Randomized Controlled Trial.","BACKGROUND
Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor, which is a period of significant physical activity, can decrease the instrumental vaginal delivery rate.
METHODS
In a multicenter, prospective, randomized, controlled trial, healthy adult pregnant women presenting with spontaneous labor were assigned to a ""Carbohydrate"" group (advised to drink 200 mL of apple or grape juice without pulp every 3 hours) or a ""Fasting"" group (water only). The primary outcome was the instrumental vaginal delivery rate. Secondary outcomes included duration of labor, rate of cesarean delivery, evaluation of maternal hunger, thirst, stress, fatigue, and overall feeling during labor by numeric rating scale (0 worst rating to 10 best rating), rate of vomiting, and hospital length of stay. Statistical analysis was performed on an intention-to-treat basis. The primary outcome was tested with the ""Fasting"" group as the reference group. The P values for secondary outcomes were adjusted for multiple comparisons. The differences between groups are reported with 99% confidence interval (CI).
RESULTS
A total of 3984 women were analyzed (2014 in the Carbohydrate group and 1970 in the Fasting group). There was no difference in the rate of instrumental delivery between the Carbohydrate (21.0%) and the Fasting (22.4%) groups (difference, -1.4%; 99% CI, -4.9 to 2.2). No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0).
CONCLUSIONS
Carbohydrate intake during labor did not modify the rate of instrumental vaginal delivery.",2020,"No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0).
","['A total of 3984 women were analyzed (2014 in the Carbohydrate group and 1970 in the Fasting group', 'healthy adult pregnant women presenting with spontaneous labor']","['Carbohydrate"" group (advised to drink 200 mL of apple or grape juice without pulp every 3 hours) or a ""Fasting"" group (water only', 'Oral Carbohydrate Intake', 'physical exercise']","['degree of self-reported fatigue', 'duration of labor', 'rate of cesarean delivery', 'instrumental vaginal delivery rate', 'self-reported hunger', 'rate of instrumental delivery', 'rate of instrumental vaginal delivery', 'muscle performance and decreases fatigue', 'rate of vomiting', 'length of hospitalization', 'Rate of Instrumental Vaginal Delivery', 'overall feeling', 'duration of labor, rate of cesarean delivery, evaluation of maternal hunger, thirst, stress, fatigue, and overall feeling during labor by numeric rating scale (0 worst rating to 10 best rating), rate of vomiting, and hospital length of stay']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0452455', 'cui_str': 'Grape juice (substance)'}, {'cui': 'C0585323', 'cui_str': 'Every three hours (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery (procedure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0222045'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",3984.0,0.23552,"No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0).
","[{'ForeName': 'Thérèse', 'Initials': 'T', 'LastName': 'Simonet', 'Affiliation': 'From the Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier Universitaire (CHU) de Caen Normandie, Caen, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Gakuba', 'Affiliation': 'From the Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier Universitaire (CHU) de Caen Normandie, Caen, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Desmeulles', 'Affiliation': 'Department of Anaesthesia, Centre Hospitalier (CH) du Cotentin, Cherbourg, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Corouge', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, CHU Jeanne de Flandre de Lille, Lille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Beucher', 'Affiliation': 'Department of Obstetrics and Gynecology, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Morello', 'Affiliation': 'Department of Biostatistics, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Gérard', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, CHU de Caen Normandie, Caen, France and University of Caen Normandy, Caen, France.'}, {'ForeName': 'Anne Sophie', 'Initials': 'AS', 'LastName': 'Ducloy-Bouthors', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, CHU Jeanne de Flandre de Lille, Lille, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Dreyfus', 'Affiliation': 'Department of Obstetrics and Gynecology, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': ""Department of Anaesthesia and Intensive Care Medicine, CHU de Caen Normandie, Caen, France and Equipe d'Accueil (EA4650) University of Caen Normandy, Caen, France.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004515']
1474,31702802,Bimodal Release Ondansetron for Acute Gastroenteritis Among Adolescents and Adults: A Randomized Clinical Trial.,"Importance
Vomiting resulting from acute gastroenteritis is commonly treated with intravenous antiemetics in acute care settings. If oral treatment were beneficial, patients might not need intravenous administered hydration or medication. Furthermore, a long-acting treatment could provide sustained relief from nausea and vomiting.
Objective
To determine whether an experimental long-acting bimodal release ondansetron tablet decreases gastroenteritis-related vomiting and eliminates the need for intravenous therapy for 24 hours after administration.
Design, Setting, and Participants
This placebo-controlled, double-blind, randomized clinical trial included patients from 19 emergency departments and 2 urgent care centers in the United States from December 8, 2014, to February 17, 2017. Patients 12 years and older with at least 2 vomiting episodes from presumed gastroenteritis in the previous 4 hours and symptoms with less than 36 hours' duration were randomized using a 3:2 active to placebo ratio. Analyses were performed on an intent-to-treat basis and conducted from June 1, 2017, to November 1, 2017.
Intervention
Bimodal release ondansetron tablet containing 6 mg of immediate release ondansetron and 18 mg of a 24-hour release matrix for a total of 24 mg of ondansetron.
Main Outcomes and Measures
Treatment success was defined as no further vomiting, no need for rescue medication, and no intravenous hydration for 24 hours after bimodal release ondansetron administration.
Results
Analysis included 321 patients (mean [SD] age, 29.0 [11.1] years; 195 [60.7%] women), with 192 patients in the bimodal release ondansetron group and 129 patients in the placebo group. Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), with an 11.4% (95% CI, 0.3%-22.4%) absolute probability difference. The proportion of treatment success was 21% higher among patients who received bimodal release ondansetron compared with those who received a placebo (relative risk, 1.21; 95% CI, 1.00-1.46; P = .04). In an analysis including only patients with a discharge diagnosis of acute gastroenteritis and no major protocol violations, there were 123 treatment successes (69.5%) in the bimodal release ondansetron group compared with 67 treatment successes (54.9%) in the placebo group (relative risk, 1.27; 95% CI, 1.05-1.53; P = .01). Adverse effects were infrequent and similar to the known safety profile of ondansetron.
Conclusions and Relevance
This randomized clinical trial found that a long-acting bimodal release oral ondansetron tablet was an effective antiemetic among adolescents and adults with moderate to severe vomiting from acute gastroenteritis. The drug benefits extended to 24 hours after administration. Bimodal release ondansetron may decrease the need for intravenous access and emergency department care to manage acute gastroenteritis.
Trial Registration
ClinicalTrials.gov identifier: NCT02246439.",2019,"Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), with an 11.4% (95% CI, 0.3%-22.4%) absolute probability difference.","['Adolescents and Adults', 'patients from 19 emergency departments and 2 urgent care centers in the United States from December 8, 2014, to February 17, 2017', 'adolescents and adults with moderate to severe vomiting from acute gastroenteritis', ""Patients 12 years and older with at least 2 vomiting episodes from presumed gastroenteritis in the previous 4 hours and symptoms with less than 36 hours' duration"", 'Acute Gastroenteritis', '321 patients (mean [SD] age, 29.0 [11.1] years; 195 [60.7%] women), with 192 patients in the bimodal release ondansetron group and 129 patients in the placebo group', '126 patients in the bimodal release']","['ondansetron', 'Bimodal Release Ondansetron', 'placebo', 'placebo ratio', 'ondansetron tablet containing 6 mg of immediate release ondansetron']","['vomiting, no need for rescue medication, and no intravenous hydration', 'discharge diagnosis of acute gastroenteritis and no major protocol violations', 'gastroenteritis-related vomiting', 'Adverse effects', 'proportion of treatment success']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1551285', 'cui_str': 'Urgent Care Clinics'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",321.0,0.535238,"Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), with an 11.4% (95% CI, 0.3%-22.4%) absolute probability difference.","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Silverman', 'Affiliation': 'Feinstein Institute for Medical Research, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, New York.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'House', 'Affiliation': 'Department of Emergency Medicine, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Meltzer', 'Affiliation': 'School of Medicine and Health Sciences, Department of Emergency Medicine, George Washington University, Washington, DC.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hahn', 'Affiliation': 'Department of Emergency Medicine, Northwell Health, New York, New York.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Lovato', 'Affiliation': 'Department of Emergency Medicine, Olive View-UCLA Medical Center, Sylmar, California.'}, {'ForeName': 'Jahn', 'Initials': 'J', 'LastName': 'Avarello', 'Affiliation': 'Department of Emergency Medicine, Northwell Health, New York, New York.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Miller', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Ira N', 'Initials': 'IN', 'LastName': 'Kalfus', 'Affiliation': 'RedHill Biopharma, Tel-Aviv, Israel.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Fathi', 'Affiliation': 'RedHill Biopharma, Tel-Aviv, Israel.'}, {'ForeName': 'Gilead', 'Initials': 'G', 'LastName': 'Raday', 'Affiliation': 'RedHill Biopharma, Tel-Aviv, Israel.'}, {'ForeName': 'Terry F', 'Initials': 'TF', 'LastName': 'Plasse', 'Affiliation': 'RedHill Biopharma, Tel-Aviv, Israel.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Yan', 'Affiliation': 'Atlantic Research Group, Charlottesville, Virginia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14988']
1475,31878845,The effect of mother-infant skin-to-skin contact on the involution process and maternal postpartum fatigue during the early postpartum period.,"Evidence has been limited on the effect of mother-infant skin-to-skin contact on the involution process and maternal postpartum fatigue. This study aimed to determine such effects in a randomized controlled trial conducted in a hospital in Sivas, Turkey. Seventy-five women were randomized into one of two groups. The Mother-Infant Information Form, Involution Process Evaluation Form and Visual Analogue Scale for Fatigue were used to collect data between October 1, 2015 and May 1, 2016. Repeated Measures ANOVAs were used for data analyzes. In the intervention group, routine care and mother-to-infant skin-to-skin contact were provided for 30 minutes in first postnatal hour. In the control group, routine care was provided. At the postnatal second, fourth and 24th hours, fundus heights were 13.4 ± 0.3, 12.9 ± 0.3 and 11.8 ± 0.3 cm, respectively, in the intervention group, and 14.4 ± 0.4, 13.8 ± 0.3 and 12.9 ± 0.3 cm in the control group ( p < .05). At the 24th hour, women in the intervention group had higher mean energy levels (29.8 ± 10.1) than the control group (25.1 ± 10.0) ( p < .05), and fatigue score, amount of lochia and number of pads were statistically similar between the groups ( p > .05). Mothers expressed satisfaction with skin-to-skin practice. Thus, mother-to-infant skin-to-skin contact can be used as a care practice in the postpartum period.",2020,"At the 24th hour, women in the intervention group had higher mean energy levels (29.8 ± 10.1) than the control group (25.1 ± 10.0) ( p < .05), and fatigue score, amount of lochia and number of pads were statistically similar between the groups ( p > .05).","['Seventy-five women', 'hospital in Sivas, Turkey']","['routine care and mother-to-infant skin-to-skin contact', 'mother-infant skin-to-skin contact']","['mean energy levels', 'maternal postpartum fatigue', 'fatigue score, amount of lochia and number of pads']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0227855', 'cui_str': 'Lochia (substance)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}]",75.0,0.0411448,"At the 24th hour, women in the intervention group had higher mean energy levels (29.8 ± 10.1) than the control group (25.1 ± 10.0) ( p < .05), and fatigue score, amount of lochia and number of pads were statistically similar between the groups ( p > .05).","[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Tosun Güleroğlu', 'Affiliation': 'Faculty of Health Sciences, Yozgat Bozok University , Yozgat, Turkey.'}, {'ForeName': 'Salime', 'Initials': 'S', 'LastName': 'Mucuk', 'Affiliation': 'Faculty of Health Sciences, University of Erciyes , Kayseri, Turkey.'}, {'ForeName': 'İzzet', 'Initials': 'İ', 'LastName': 'Özgürlük', 'Affiliation': 'Gynecology, Dr. Abdurrahman Yurtarslan Oncology Education and Research Hospital , Ankara, Turkey.'}]",Women & health,['10.1080/03630242.2019.1707747']
1476,30770244,Comparison of intravenous lidocaine/ketorolac combination to either analgesic alone for suspected renal colic pain in the ED.,"STUDY OBJECTIVE
To compare analgesic efficacy and safety of intravenous lidocaine and ketorolac combination to each analgesic alone for ED patients with suspected renal colic.
METHODS
We conducted a randomized, double-blind trial comparing analgesic efficacy of a combination of intravenous lidocaine (1.5 mg/kg) and ketorolac (30 mg), to ketorolac (30 mg), and to lidocaine (1.5 mg/kg) in patients aged 18-64 presenting to the ED with suspected renal colic. Primary outcome included difference in pain scores between the groups at 30 min. Secondary outcomes included a comparative reduction in pain scores in each group from baseline to 30 and 60 min as well as rates of adverse events and need for rescue analgesia at 30 and 60 min.
RESULTS
We enrolled 150 subjects (50 per group). The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89 (95% CI: -4.39 to -1.39); between Ketorolac and Lidocaine/Ketorolac group was -0.92 (95% CI: -2.44 to 0.61); and between Ketorolac and Lidocaine was -1.98 (95% CI: -3.69 to -0.27). A comparative percentage of subjects in each group required rescue analgesia at 30 and 60 min. No clinically concerning changes in vital signs were observed. No serious adverse events occurred in either group. Commonly reported adverse effects were dizziness, nausea, and headache.
CONCLUSION
The administration of intravenous lidocaine/ketorolac combination to ED patients with suspected renal colic results in better analgesia in comparison to lidocaine alone but provides no analgesic advantages over ketorolac alone. Clinicaltrials.gov Registration: NCT02902770.",2020,The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89,"['ED patients with suspected renal colic', 'We enrolled 150 subjects (50 per group', 'patients aged 18-64 presenting to the ED with suspected renal colic']","['Ketorolac', 'Lidocaine', 'lidocaine', 'lidocaine and ketorolac combination', 'ketorolac', 'analgesic alone', 'lidocaine/ketorolac', 'Lidocaine/Ketorolac', 'intravenous lidocaine']","['comparative reduction in pain scores', 'mean pain scores', 'rescue analgesia', 'rates of adverse events and need for rescue analgesia at 30 and 60\u202fmin', 'suspected renal colic pain', 'analgesic efficacy and safety', 'pain scores', 'vital signs', 'dizziness, nausea, and headache', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518766'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",150.0,0.368904,The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89,"[{'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Motov', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Catsim', 'Initials': 'C', 'LastName': 'Fassassi', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Drapkin', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA. Electronic address: jdrapkin@maimonidesmed.org.'}, {'ForeName': 'Mahlaqa', 'Initials': 'M', 'LastName': 'Butt', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Rukhsana', 'Initials': 'R', 'LastName': 'Hossain', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Likourezos', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Monfort', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Brady', 'Affiliation': 'Department of Pharmacy, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Nechama', 'Initials': 'N', 'LastName': 'Rothberger', 'Affiliation': 'Department of Pharmacy, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Stefan S', 'Initials': 'SS', 'LastName': 'Mann', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Flom', 'Affiliation': 'Peter Flom Consulting, New York, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Gulati', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.01.048']
1477,30738708,"Re: Timu J. Murtola, Hemo Syvälä, Teemu Tolonen, et al. Atorvastatin Versus Placebo for Prostate Cancer Before Radical Prostatectomy-A Randomized, Double-blind, Placebo-controlled Clinical Trial. Eur Urol 2018;74:697-701.",,2019,,['Prostate Cancer'],"['Placebo', 'Atorvastatin Versus Placebo']",[],"[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]",[],,0.311716,,"[{'ForeName': 'Jae Heon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Stanford University Medical Center, CA, USA; Department of Urology, Soonchunhyang University Hospital, Soonchuhyang University Medical College, Seoul, South Korea. Electronic address: piacekjh@hanmail.net.'}, {'ForeName': 'Benjamin I', 'Initials': 'BI', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, Stanford University Medical Center, CA, USA.'}]",European urology,['10.1016/j.eururo.2019.01.042']
1478,32408153,Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis.,"BACKGROUND
Fasting-mimicking diets have shown promise in experimental autoimmune encephalitis and are currently being investigated among people with multiple sclerosis (MS). Ensuring adherence to diet changes is critical to determining the efficacy of such interventions.
OBJECTIVE
Our primary aim was to evaluate the safety and feasibility of several fasting-mimicking diets and investigate whether various levels of clinical support improve diet adherence among people with MS. Secondarily, this study evaluated the impact of fasting-mimicking diets on weight and patient-reported outcomes (PROs).
METHODS
We conducted three pilot studies (two randomized controlled for 6 months; one randomized with transition to single arm) restricting either the amount or timing of calorie intake over 24 or 48 weeks. Interventions included calorie restriction (daily or intermittently) or time-restricted feeding. Adherence measures varied across studies but were collected at study visits along with weight and PRO data.
RESULTS
A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported. Overall adherence to the calorie restriction diets was poor. When participants were tasked with maintaining a diet in a pragmatic setting, neither previously completed intense clinical support and education, nor weekly electronic communication throughout the diet period appeared to improve diet adherence. Participants who were able to adhere to a calorie restriction diet predictably lost weight. In contrast to calorie restriction, adherence to a time-restricted feeding (TRF) diet was relatively good. No statistically significant changes in PROs were observed in an intention-to-treat analysis.
CONCLUSION
The role diet may play in clinical outcomes in MS remains unknown, as class I evidence is lacking. Diet adherence remains a primary barrier to the feasible conduct of large, randomized controlled diet trials. Strict adherence to a TRF dietary change may be more feasible than calorie restriction and should be considered in future fasting-mimicking diet trials. ClinicalTrials.gov Registry:A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis - NCT02647502. A Pragmatic Trial of Dietary Programs in People with Multiple Sclerosis (MS) - NCT02846558.",2020,"No statistically significant changes in PROs were observed in an intention-to-treat analysis.
","['people with MS', 'Participants who were able to adhere to a calorie restriction diet predictably lost weight', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'People with Multiple Sclerosis (MS) - NCT02846558', 'A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported']","['Dietary Programs', 'various fasting-mimicking diets', 'Intermittent Calorie Restriction', 'several fasting-mimicking diets']","['PROs', 'calorie restriction (daily or intermittently) or time-restricted feeding', 'Overall adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",90.0,0.0618671,"No statistically significant changes in PROs were observed in an intention-to-treat analysis.
","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Roman', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State. Electronic address: sroman6@jhmi.edu.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beier', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Mowry', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102149']
1479,31694410,Reasons for the Failure of Platelet Function Testing to Adjust Antiplatelet Therapy: Pharmacodynamic Insights From the ARCTIC Study.,"BACKGROUND
In the ARCTIC trial (Assessment by a Double Randomization of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption Versus Continuation One Year After Stenting), treatment adjustment following platelet function testing failed to improve clinical outcomes. However, high-on-treatment platelet reactivity (HPR) is considered as a predictor of poor ischemic outcome. This prespecified substudy evaluated clinical outcomes according to the residual platelet reactivity status after antiplatelet therapy adjustment.
METHODS
We analyzed the 1213 patients assigned to the monitoring arm of the ARCTIC trial in whom platelet reactivity was evaluated by the VerifyNow P2Y 12 test before percutaneous coronary intervention and during the maintenance phase (at 14 days). HPR was defined as platelet reaction unit≥235U. The primary ischemic end point, a composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization and the safety end point of major bleeding were assessed according to the platelet reactivity status.
RESULTS
Before percutaneous coronary intervention, 35.7% of patients displayed HPR (n=419). During the acute phase, between percutaneous coronary intervention and the 14-day platelet function testing, ischemic (adjusted hazard ratio, 0.94 [95% CI, 0.74-1.18]; P =0.58) and safety outcomes (hazard ratio, 1.28 [95% CI, 0.22-7.59]; P =0.78) were similar in HPR and non-HPR patients. During the maintenance phase, the proportion of HPR patients (n=186, 17.4%) decreased by 56%. At 1-year, there was no difference for the ischemic end point (5.9% versus 6.0%; adjusted hazard ratio, 0.79 [95% CI, 0.40-1.58]; P =0.51) and a nonsignificant higher rate of major bleedings (2.7% versus 1.0%, hazard ratio, 2.83 [95% CI, 0.96-8.41]; P =0.06) in HPR versus non-HPR patients.
CONCLUSIONS
The proportion of HPR was halved after platelet function testing and treatment adjustment but without significant ischemic benefit at 1 year. HPR seems more as a modifiable risk marker than a risk factor of ischemic outcome.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT00827411.",2019,The proportion of HPR was halved after platelet function testing and treatment adjustment but without significant ischemic benefit at 1 year.,['1213 patients assigned to the monitoring arm of the ARCTIC trial in whom platelet reactivity was evaluated by the VerifyNow P2Y 12 test before percutaneous coronary intervention and during the maintenance phase (at 14 days'],[],"['platelet reactivity status', 'composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization and the safety end point of major bleeding', 'proportion of HPR', 'HPR', 'safety outcomes', 'rate of major bleedings', 'platelet reaction unit≥235U']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",[],"[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",1213.0,0.104207,The proportion of HPR was halved after platelet function testing and treatment adjustment but without significant ischemic benefit at 1 year.,"[{'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Paris, France (B.L., J.S., Y.Y., G.M., J.-P.C.).'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Paris, France (B.L., J.S., Y.Y., G.M., J.-P.C.).'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Paris, France (B.L., J.S., Y.Y., G.M., J.-P.C.).'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pouillot', 'Affiliation': 'Cardiology Department, Sainte Clotilde Clinic, St. Denis de la Réunion, France (C.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'ACTION Study Group, Cardiology Department, La Timone Hospital, Marseille, France (T.C.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Cardiology Department, Caremeau University Hospital, ACTION Study Group, Montpellier University, Nîmes, France (B.L., G.C.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Henry', 'Affiliation': 'Cardiology Department (P.H.), Lariboisière University Hospital, Paris, France.'}, {'ForeName': 'Abdourahmane', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'ACTION Study Group, Epidemiology and Clinic Research Unit (A.D., E.V.), Lariboisière University Hospital, Paris, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Elhadad', 'Affiliation': 'Cardiology department, Lagny-Marne la Vallée Hospital, France (S.E.).'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Rangé', 'Affiliation': 'Cardiology department, Chartres Hospital, Le Coudray, France (G.R.).'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Lhermusier', 'Affiliation': 'Cardiology Department, Rangueil University Hospital, Toulouse, France (T.L., D.C.).'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'Cardiology Department, Bastia Hospital, France (Z.B.).'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Motreff', 'Affiliation': 'Cardiology Department, Gabriel Montpied University Hospital, Clermont-Ferrand, France (P.M.).'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'Cardiology Department, Rangueil University Hospital, Toulouse, France (T.L., D.C.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'ACTION Study Group, Epidemiology and Clinic Research Unit (A.D., E.V.), Lariboisière University Hospital, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Paris, France (B.L., J.S., Y.Y., G.M., J.-P.C.).'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Paris, France (B.L., J.S., Y.Y., G.M., J.-P.C.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.118.007749']
1480,30770294,"Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial.","BACKGROUND
In the PROSPER trial, enzalutamide significantly improved metastasis-free survival in patients with non-metastatic, castration-resistant prostate cancer. Here, we report the results of patient-reported outcomes of this study.
METHODS
In the randomised, double-blind, placebo-controlled, phase 3 PROSPER trial, done at 254 study sites worldwide, patients aged 18 years or older with non-metastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of up to 10 months were randomly assigned (2:1) via an interactive voice web recognition system to receive oral enzalutamide (160 mg per day) or placebo. Randomisation was stratified by prostate-specific antigen doubling time and baseline use of a bone-targeting agent. The primary endpoint was metastasis-free survival, reported elsewhere. Secondary efficacy endpoints, reported here, were pain progression (assessed by the Brief Pain Inventory Short Form [BPI-SF] questionnaire) and health-related quality of life (assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-PR25], the EuroQoL 5-Dimensions 5-Levels health questionnaire visual analogue scale [EQ-5D-FL, EQ-VAS], and the Functional Assessment of Cancer Therapy-Prostate [FACT-P] questionnaires). Patients completed questionnaires at baseline, week 17, and every 16 weeks thereafter until treatment discontinuation. We used predefined questionnaire thresholds to identify clinically meaningful changes. Enrolment for PROSPER is complete and follow-up continues. This trial is registered with ClinicalTrials.gov, number NCT02003924.
FINDINGS
Between Nov 26, 2013, and June 28, 2017, 1401 patients were enrolled and randomly assigned to receive enzalutamide (n=933) or placebo (n=468). Median follow-up was 18·5 months (IQR 10·7-29·2) in the enzalutamide group and 15·1 months (7·4-25·9) in the placebo group. Patient-reported outcome scores at baseline were similar between groups. Changes in least squares mean from baseline to week 97 favoured enzalutamide versus placebo for FACT-P social and family wellbeing (0·30 [95% CI -0·25 to 0·85] vs -0·64 [-1·51 to 0·24]; difference 0·94 [95% CI 0·02 to 1·85]; p=0·045) and disfavoured enzalutamide versus placebo for EORTC QLQ-PR25 hormonal treatment-related symptoms (1·55 [0·26 to 2·83) vs -1·83 [-3·86 to 0·20]; difference 3·38 [1·24 to 5·51]; p=0·0020); neither of these changes were clinically meaningful. No significant differences were observed between treatments for changes from baseline to week 97 in any other patient-reported outcome score. Time to clinically meaningful pain progression as assessed by BPI-SF pain severity was longer with enzalutamide than with placebo (median 36·83 months, [95% CI 34·69 to not reached [NR] vs NR; hazard ratio [HR] 0·75 [95% CI 0·57 to 0·97]; p=0·028); there was no significant difference for BPI-SF item 3 or pain interference. Time to clinically meaningful symptom worsening was longer with enzalutamide than with placebo for EORTC QLQ-PR25 urinary symptoms (median 36·86 months [95% CI 33·35 to NR] vs 25·86 [18·53 to 29·47]; HR 0·58 [95% CI 0·46 to 0·72]; p<0·0001) and bowel symptoms (33·15 [29·50 to NR] vs 25·89 [18·43 to 29·67]; 0·72 [0·59 to 0·89]; p=0·0018), and clinically meaningful health-related quality of life as assessed by FACT-P total score (22·11 [18·63 to 25·86] vs 18·43 [14·85-19·35]; 0·83 [0·69 to 0·99]; p=0·037), emotional wellbeing (36·73 [33·12 to 38·21] vs 29·47 [22·18 to 33·15]; 0·69 [0·55 to 0·86]; p=0·0008), and prostate cancer subscale (18·43 [14·85 to 18·66] vs 14·69 [11·07 to 16·20]; 0·79 [0·67 to 0·93]; p=0·0042), although there was no significant difference for other FACT-P scores. Time to clinically meaningful deterioration in EORTC QLQ-PR25 hormonal treatment-related symptoms was shorter with enzalutamide than with placebo (median 33·15 months [95% CI 29·60 to NR] vs 36·83 [29·47 to NR]; HR 1·29 [95% CI 1·02 to 1·63]; p=0·035). Time to deterioration of EQ-VAS was significantly longer for enzalutamide than for placebo (median 22·11 months [95% CI 18·46 to 25·66] vs 14·75 [11·07 to 18·17]; HR 0·75 [95% CI 0·63 to 0·90]; p=0·0013).
INTERPRETATION
Patients with non-metastatic, castration-resistant prostate cancer receiving enzalutamide had longer metastasis-free survival than did those who received placebo, while maintaining low pain levels and prostate cancer symptom burden and high health-related quality of life. Enzalutamide showed a clinical benefit by delaying pain progression, symptom worsening, and decrease in functional status, compared with placebo. These findings suggest that enzalutamide is a treatment option that should be discussed with patients presenting with high-risk, non- metastatic, castration-resistant prostate cancer.
FUNDING
Astellas Pharma Inc, Medivation LLC (a Pfizer Company).",2019,p=0·028); there was no significant difference for BPI-SF item 3 or pain interference.,"['Patients with non-metastatic, castration-resistant prostate cancer receiving', 'patients aged 18 years or older with non-metastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of up to 10 months', '1401 patients', 'patients presenting with high-risk, non- metastatic, castration-resistant prostate cancer', 'Between Nov 26, 2013, and June 28, 2017', '0·69', 'men with non-metastatic, castration-resistant prostate cancer (PROSPER', 'patients with non-metastatic, castration-resistant prostate cancer']","['enzalutamide versus placebo', 'interactive voice web recognition system to receive oral enzalutamide', 'placebo', '33·15', 'enzalutamide', 'enzalutamide or placebo', 'Enzalutamide']","['EORTC QLQ-PR25 urinary symptoms', 'metastasis-free survival', 'pain progression, symptom worsening, and decrease in functional status', 'BPI-SF pain severity', 'Time to clinically meaningful pain progression', 'clinically meaningful health-related quality of life as assessed by FACT-P total score', 'bowel symptoms', 'emotional wellbeing (36·73', 'low pain levels and prostate cancer symptom burden and high health-related quality of life', 'BPI-SF item 3 or pain interference', 'FACT-P scores', 'Time to deterioration of EQ-VAS', 'prostate cancer subscale (18·43', 'pain progression (assessed by the Brief Pain Inventory Short Form [BPI-SF] questionnaire) and health-related quality of life (assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-PR25], the EuroQoL 5-Dimensions 5-Levels health questionnaire visual analogue scale [EQ-5D-FL, EQ-VAS], and the Functional Assessment of Cancer Therapy-Prostate [FACT-P] questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]",1401.0,0.730286,p=0·028); there was no significant difference for BPI-SF item 3 or pain interference.,"[{'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium. Electronic address: bertrand.tombal@uclouvain.be.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Centre hospitalier de l'Université de Montréal/CRCHUM, Montreal, Quebec, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Penson', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Northwestern University Robert H Lurie Comprehensive Cancer Center, Chicago, IL, USA.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Morlock', 'Affiliation': 'Astellas Pharma Inc, Northbrook, IL, USA.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramaswamy', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ivanescu', 'Affiliation': 'IQVIA, Amsterdam, Netherlands.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'University College London Cancer Institute, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30898-2']
1481,30770291,"Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial.","BACKGROUND
Stereotactic ablative body radiotherapy (SABR) is widely used to treat inoperable stage 1 non-small-cell lung cancer (NSCLC), despite the absence of prospective evidence that this type of treatment improves local control or prolongs overall survival compared with standard radiotherapy. We aimed to compare the two treatment techniques.
METHODS
We did this multicentre, phase 3, randomised, controlled trial in 11 hospitals in Australia and three hospitals in New Zealand. Patients were eligible if they were aged 18 years or older, had biopsy-confirmed stage 1 (T1-T2aN0M0) NSCLC diagnosed on the basis of 18 F-fluorodeoxyglucose PET, and were medically inoperable or had refused surgery. Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, and the tumour had to be peripherally located. Patients were randomly assigned after stratification for T stage and operability in a 2:1 ratio to SABR (54 Gy in three 18 Gy fractions, or 48 Gy in four 12 Gy fractions if the tumour was <2 cm from the chest wall) or standard radiotherapy (66 Gy in 33 daily 2 Gy fractions or 50 Gy in 20 daily 2·5 Gy fractions, depending on institutional preference) using minimisation, so no sequence was pre-generated. Clinicians, patients, and data managers had no previous knowledge of the treatment group to which patients would be assigned; however, the treatment assignment was subsequently open label (because of the nature of the interventions). The primary endpoint was time to local treatment failure (assessed according to Response Evaluation Criteria in Solid Tumors version 1.0), with the hypothesis that SABR would result in superior local control compared with standard radiotherapy. All efficacy analyses were based on the intention-to-treat analysis. Safety analyses were done on a per-protocol basis, according to treatment that the patients actually received. The trial is registered with ClinicalTrials.gov (NCT01014130) and the Australia and New Zealand Clinical Trials Registry (ACTRN12610000479000). The trial is closed to new participants.
FINDINGS
Between Dec 31, 2009, and June 22, 2015, 101 eligible patients were enrolled and randomly assigned to receive SABR (n=66) or standard radiotherapy (n=35). Five (7·6%) patients in the SABR group and two (6·5%) in the standard radiotherapy group did not receive treatment, and a further four in each group withdrew before study end. As of data cutoff (July 31, 2017), median follow-up for local treatment failure was 2·1 years (IQR 1·2-3·6) for patients randomly assigned to standard radiotherapy and 2·6 years (IQR 1·6-3·6) for patients assigned to SABR. 20 (20%) of 101 patients had progressed locally: nine (14%) of 66 patients in the SABR group and 11 (31%) of 35 patients in the standard radiotherapy group, and freedom from local treatment failure was improved in the SABR group compared with the standard radiotherapy group (hazard ratio 0·32, 95% CI 0·13-0·77, p=0·0077). Median time to local treatment failure was not reached in either group. In patients treated with SABR, there was one grade 4 adverse event (dyspnoea) and seven grade 3 adverse events (two cough, one hypoxia, one lung infection, one weight loss, one dyspnoea, and one fatigue) related to treatment compared with two grade 3 events (chest pain) in the standard treatment group.
INTERPRETATION
In patients with inoperable peripherally located stage 1 NSCLC, compared with standard radiotherapy, SABR resulted in superior local control of the primary disease without an increase in major toxicity. The findings of this trial suggest that SABR should be the treatment of choice for this patient group.
FUNDING
The Radiation and Optometry Section of the Australian Government Department of Health with the assistance of Cancer Australia, and the Cancer Society of New Zealand and the Cancer Research Trust New Zealand (formerly Genesis Oncology Trust).",2019,"In patients with inoperable peripherally located stage 1 NSCLC, compared with standard radiotherapy, SABR resulted in superior local control of the primary disease without an increase in major toxicity.","['patients with inoperable peripherally located stage 1 NSCLC', 'Between Dec 31, 2009, and June 22, 2015, 101 eligible patients', '11 hospitals in Australia and three hospitals in New Zealand', 'Patients were eligible if they were aged 18 years or older, had biopsy-confirmed stage 1 (T1-T2aN0M0', 'NSCLC diagnosed on the basis of 18 F-fluorodeoxyglucose PET, and were medically inoperable or had refused surgery', 'Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, and the tumour had to be peripherally located']","['standard radiotherapy, SABR', 'standard radiotherapy', 'SABR', 'Stereotactic ablative radiotherapy', 'Stereotactic ablative body radiotherapy (SABR']","['grade 4 adverse event (dyspnoea) and seven grade 3 adverse events (two cough, one hypoxia, one lung infection, one weight loss, one dyspnoea, and one fatigue', 'Median time to local treatment failure', 'time to local treatment failure', 'freedom from local treatment failure', 'major toxicity', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",101.0,0.257768,"In patients with inoperable peripherally located stage 1 NSCLC, compared with standard radiotherapy, SABR resulted in superior local control of the primary disease without an increase in major toxicity.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ball', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. Electronic address: david.ball@petermac.org.'}, {'ForeName': 'G Tao', 'Initials': 'GT', 'LastName': 'Mai', 'Affiliation': 'Princess Alexandra Hospital and University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Vinod', 'Affiliation': 'Liverpool Hospital and University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Babington', 'Affiliation': 'Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Ruben', 'Affiliation': 'Alfred Hospital and Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kron', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Chesson', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Melbourne, VIC, Australia.'}, {'ForeName': 'Marijana', 'Initials': 'M', 'LastName': 'Vanevski', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Melbourne, VIC, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Rezo', 'Affiliation': 'Canberra Hospital, Canberra, ACT, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elder', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Skala', 'Affiliation': 'Royal Hobart Hospital, Tasmania, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wirth', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Wheeler', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Lim', 'Affiliation': 'Austin Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Shaw', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Schofield', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Swinburne University, Melbourne, VIC, Australia.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Irving', 'Affiliation': 'Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Solomon', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30896-9']
1482,30764711,Self-efficacy predicts response to cognitive rehabilitation in military service members with post-concussive symptoms.,"This study examined whether self-efficacy differentiated treatment responders from non-responders in a trial of cognitive rehabilitation (CR) for postconcussive symptoms. 126 service members with mild TBI seen on average 9.5 months since injury completed one of four cognitive rehabilitation treatments for 6 weeks. The four treatment arms were: (1) Psychoeducation control, (2) Self-administered computerized CR, (3) Interdisciplinary CR, and (4) Interdisciplinary CR integrated with CBT. Outcome was assessed across time (baseline, and 6, 12, and 18 weeks post-treatment) for three domains: psychological (Symptom Checklist-90-Revised; SCL-90-R), cognitive (Paced Auditory Serial Addition Test; PASAT), and functional/behavioural (Key Behaviors Change Inventory; KBCI). Mixed model ANOVAs tested for self-efficacy differences across time in treatment responders versus non-responders, as defined by reliable change indices. A significant interaction was found on the SCL-90 such that responders had increasing self-efficacy with respect to psychological symptoms across four time points, whereas non-responders' self-efficacy did not change. Perceived self-efficacy at the beginning of treatment was associated with treatment engagement within the psychological domain for responders only, suggesting a mediating role in treatment outcome. Overall, results suggest that increasing patients' level of self-efficacy may be important for successful treatment of psychological distress in those with remote concussion.",2020,"A significant interaction was found on the SCL-90 such that responders had increasing self-efficacy with respect to psychological symptoms across four time points, whereas non-responders' self-efficacy did not change.","['military service members with post-concussive symptoms', '126 service members with mild TBI seen on average 9.5 months since injury']","['cognitive rehabilitation', 'Psychoeducation control, (2) Self-administered computerized CR, (3) Interdisciplinary CR, and (4) Interdisciplinary CR integrated with CBT', 'cognitive rehabilitation (CR']","['psychological (Symptom Checklist-90-Revised; SCL-90-R), cognitive (Paced Auditory Serial Addition Test; PASAT), and functional/behavioural (Key Behaviors Change Inventory; KBCI', 'Perceived self-efficacy', 'self-efficacy']","[{'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0546983', 'cui_str': 'Post-Concussion Symptoms'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C0589060', 'cui_str': 'Paced Auditory Serial Addition Test'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0238215,"A significant interaction was found on the SCL-90 such that responders had increasing self-efficacy with respect to psychological symptoms across four time points, whereas non-responders' self-efficacy did not change.","[{'ForeName': 'Heather G', 'Initials': 'HG', 'LastName': 'Belanger', 'Affiliation': 'Defense and Veterans Brain Injury Center (DVBIC), Special Operations Command (SOCOM), Tampa, FL, USA.'}, {'ForeName': 'Rodney D', 'Initials': 'RD', 'LastName': 'Vanderploeg', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Curtiss', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Armistead-Jehle', 'Affiliation': 'Concussion Clinic, Munson Army Health Center, Fort Leavenworth, KS, USA.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Kennedy', 'Affiliation': 'Department of Rehabilitation Medicine, Brooke Army Medical Center (BAMC).'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Missouri Institute of Mental Health and University of Missouri, St Louis, MO, USA.'}, {'ForeName': 'Blessen C', 'Initials': 'BC', 'LastName': 'Eapen', 'Affiliation': 'Polytrauma Rehabilitation Center, South Texas Veterans Health Care System, San Antonio, TX, USA.'}, {'ForeName': 'Amy O', 'Initials': 'AO', 'LastName': 'Bowles', 'Affiliation': 'Department of Rehabilitation Medicine, Brooke Army Medical Center (BAMC).'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'Cooper', 'Affiliation': 'Polytrauma Rehabilitation Center, South Texas Veterans Health Care System, San Antonio, TX, USA.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2019.1575245']
1483,31695600,Pulsed Electrical Stimulation of the Human Eye Enhances Retinal Vessel Reaction to Flickering Light.,"Recent studies indicate therapeutic benefits of electrical stimulation in cases of specific ophthalmic diseases that are associated with dysfunctional ocular microcirculation. This suggests effects of electrical stimulation on vascular functions. In the present study, we investigated the effects of electrical stimulation on retinal vessel reactions using dynamic vessel analysis (DVA). Eighty healthy subjects were randomly assigned to one of three groups receiving electrical stimulation with different current intensities: 400 μA ( n = 26); 800 μA ( n = 27); 1200 μA ( n = 27). The electrode montage for electrical stimulation consisted of a ring-shaped active electrode surrounding one eye and a square return electrode at the occiput. Rectangular, monophasic, positive current pulses were applied at 10 Hz for a duration of 60 s per stimulation period. DVA was used to observe the stimulation-induced reactions of retinal vessel diameters in response to different provocations. In three DVA measurements, three stimulus conditions were investigated: flicker light stimulation (FLS); electrical stimulation (ES); simultaneous electrical and flicker light stimulation (ES+FLS). Retinal vasodilation caused by these stimuli was compared using paired t -test. The subjects receiving electrical stimulation with 800 μA showed significantly increased retinal vasodilation for ES+FLS compared to FLS ( p < 0.05). No significant differences in retinal vessel reactions were found between ES+FLS and FLS in the 400 and 1200 μA groups. No retinal vasodilation was observed for ES for all investigated current intensities. The results indicate that positive pulsed electrical stimulation of an adequate intensity enhances the flicker light-induced retinal vasodilation.",2019,No significant differences in retinal vessel reactions were found between ES+FLS and FLS in the 400 and 1200 μA groups.,['Eighty healthy subjects'],"['electrical stimulation', 'DVA', 'electrical stimulation with different current intensities: 400 μA']","['retinal vessel reactions', 'flicker light stimulation (FLS); electrical stimulation (ES); simultaneous electrical and flicker light stimulation (ES+FLS', 'vascular functions', 'retinal vasodilation', 'Retinal vasodilation', 'flicker light-induced retinal vasodilation', 'retinal vasodilation for ES+FLS']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0035330', 'cui_str': 'Retinal Blood Vessels'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",80.0,0.0284972,No significant differences in retinal vessel reactions were found between ES+FLS and FLS in the 400 and 1200 μA groups.,"[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Freitag', 'Affiliation': 'Institute for Biomedical Engineering and Informatics, Technische Universität Ilmenau, Ilmenau, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hunold', 'Affiliation': 'Institute for Biomedical Engineering and Informatics, Technische Universität Ilmenau, Ilmenau, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Klemm', 'Affiliation': 'Institute for Biomedical Engineering and Informatics, Technische Universität Ilmenau, Ilmenau, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Klee', 'Affiliation': 'Institute for Biomedical Engineering and Informatics, Technische Universität Ilmenau, Ilmenau, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Link', 'Affiliation': 'Institute for Biomedical Engineering and Informatics, Technische Universität Ilmenau, Ilmenau, Germany.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Nagel', 'Affiliation': 'Institute for Biomedical Engineering and Informatics, Technische Universität Ilmenau, Ilmenau, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haueisen', 'Affiliation': 'Institute for Biomedical Engineering and Informatics, Technische Universität Ilmenau, Ilmenau, Germany.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2019.00371']
1484,31706886,The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis.,"PURPOSE
To present final, 2-year results of a randomized trial comparing paclitaxel-coated vs uncoated balloon angioplasty following vessel preparation with ultra-high-pressure percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistulae (AVFs).
MATERIALS AND METHODS
Twenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm. Before 1:1 randomization, successful vessel preparation was achieved (full waist effacement, < 30% residual stenosis). Follow-up was clinically driven except for a 6-month office visit.
RESULTS
Ninety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study. Target lesion primary patency (TLPP) rates for the DCB and control groups were 58% ± 4 vs 46% ± 4 (P = .02) at 9 months, 44% ± 5 vs 36% ± 4 (P = .04) at 12 months, 34% ± 5 vs 28% ± 4 (P = .06) at 18 months, and 27% ± 4 vs 24% ± 4 (P = .09) at 24 months, respectively. Mean time to TLPP event for subjects with an event was longer for DCBs (322 vs 207 d; P < .0001). Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19). The noninferiority safety target was met at all intervals (P < .01). Mortality did not differ between groups (P = .27). Post hoc analyses showed equivalent DCB effect in all subgroups.
CONCLUSIONS
Two-year results demonstrate long-term safety and variable efficacy of DCB angioplasty in AVFs.",2020,"Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19).","['Twenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm', 'hemodialysis arteriovenous fistulae (AVFs', 'Arteriovenous Fistula Stenosis', 'Ninety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study']","['DCB angioplasty', 'Paclitaxel-Coated Balloons', 'paclitaxel-coated vs uncoated balloon angioplasty', 'ultra-high-pressure percutaneous transluminal angioplasty (PTA']","['maintain target lesion patency', 'Mortality', 'Target lesion primary patency (TLPP) rates', 'equivalent DCB effect', 'Mean time to TLPP event', 'successful vessel preparation']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous (qualifier value)'}, {'cui': 'C0340908', 'cui_str': 'Arteriovenous fistula stenosis (disorder)'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}]","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}]",285.0,0.122314,"Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19).","[{'ForeName': 'Scott O', 'Initials': 'SO', 'LastName': 'Trerotola', 'Affiliation': 'Department of Radiology, Perelman School of Medicine at the University of Pennsylvania, 1 Silverstein, 3400 Spruce St., Philadelphia, PA 19104. Electronic address: streroto@uphs.upenn.edu.'}, {'ForeName': 'Theodore F', 'Initials': 'TF', 'LastName': 'Saad', 'Affiliation': 'Section of Renal and Hypertensive Diseases, Christiana Care Health System, Newark, Delaware.'}, {'ForeName': 'Prabir', 'Initials': 'P', 'LastName': 'Roy-Chaudhury', 'Affiliation': 'University of North Carolina Kidney Center, Chapel Hill, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.08.035']
1485,30724635,Treatment Effects of Botulinum Toxin Injection and Acupuncture on Blepharospasm Assessed by the Change in Lower Eyelid Tension.,"Objective : To investigate the treatment effects of botulinum toxin-A (BTA) injection and acupuncture on blepharospasm (BP) evaluated by the change in lower eyelid tension (LET). Methods : A series of 30 patients (male: 8, female: 22) aged between 37 and 83 years (63.80 ± 10.96 yrs) who met the eligibility criteria of BP were recruited in this study, who were randomly assigned to BTA injection group (BTA group, n = 15) and acupuncture treatment group (Acupuncture group, n = 15). BTA injections were administered to the patients in BTA group while patients in acupuncture group received the acupuncture treatment. The LET was measured by a tensiometer in both groups at baseline and at post-treatment. Results : A significant decrease in LETs over 8 weeks was found in acupuncture group (812.76 ± 193.95 Pa at baseline, 549.69 ± 150.04 Pa at 4 weeks, and 510.96 ± 150.66 Pa at 8weeks, respectively; F = 31.127, p << 0.001). There was a significant decrease in LET from 858.61 ± 190.54 Pa at baseline to 414.45 ± 63.38 Pa at 2 weeks after treatment ( Z = -4.542, p << 0.01) in BTA group. At the endpoint of the study, a significant difference in LET was found between the acupuncture group (301.80 ± 181.77 Pa) and the BTA group (444.16 ± 193.44 Pa) ( t = -2.077, p = 0.047). Conclusions : BP patients have an increased LET. Both BTA and acupuncture are effective in decreasing the LET. Close monitoring of LET holds promise in planning the treatment strategy for Blepharospasm.",2019,"A significant decrease in LETs over 8 weeks was found in acupuncture group (812.76 ± 193.95 Pa at baseline, 549.69 ± 150.04 Pa at 4 weeks, and 510.96 ± 150.66 ","['30 patients (male: 8, female: 22) aged between 37 and 83\xa0years (63.80\xa0±\xa010.96\xa0yrs) who met the eligibility criteria of BP']","['botulinum toxin-A (BTA) injection and acupuncture', 'Botulinum Toxin Injection and Acupuncture', 'acupuncture treatment', 'LET', 'BTA injections', 'acupuncture', 'BTA and acupuncture', 'BTA injection group (BTA group, n =\xa015) and acupuncture treatment group (Acupuncture group, n =\xa015']","['LET', 'blepharospasm (BP', 'LETs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}]",,0.0663449,"A significant decrease in LETs over 8 weeks was found in acupuncture group (812.76 ± 193.95 Pa at baseline, 549.69 ± 150.04 Pa at 4 weeks, and 510.96 ± 150.66 ","[{'ForeName': 'Fang-Fang', 'Initials': 'FF', 'LastName': 'Bao', 'Affiliation': 'a Department of Ophthalmology, Putuo Hospital , Shanghai University of Traditional Chinese Medicine , Shanghai , China.'}, {'ForeName': 'Qing-Song', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'a Department of Ophthalmology, Putuo Hospital , Shanghai University of Traditional Chinese Medicine , Shanghai , China.'}, {'ForeName': 'Zhen-Yong', 'Initials': 'ZY', 'LastName': 'Zhang', 'Affiliation': 'a Department of Ophthalmology, Putuo Hospital , Shanghai University of Traditional Chinese Medicine , Shanghai , China.'}, {'ForeName': 'Min-Hong', 'Initials': 'MH', 'LastName': 'Xiang', 'Affiliation': 'a Department of Ophthalmology, Putuo Hospital , Shanghai University of Traditional Chinese Medicine , Shanghai , China.'}]",Current eye research,['10.1080/02713683.2019.1578379']
1486,31557067,Final Analysis of DeCOG-SLT Trial: No Survival Benefit for Complete Lymph Node Dissection in Patients With Melanoma With Positive Sentinel Node.,"PURPOSE
We have previously reported on the 3-year results of the phase III German Dermatologic Cooperative Oncology Group trial (DeCOG; ClinicalTrials.gov identifier: NCT02434107) comparing distant metastasis-free survival (DMFS), recurrence-free survival (RFS), and overall survival (OS) in patients with positive sentinel lymph-node biopsy who were randomly assigned to complete lymph node dissection (CLND) or observation. Here, we report the final analysis with 72 months of median follow up.
PATIENTS AND METHODS
The multicenter randomized phase III trial included patients with cutaneous melanoma of the trunk and extremities who were randomly assigned (1:1) to undergo CLND or observation. DMFS was analyzed as the primary end point, and RFS, OS, and recurrences in the regional lymph node basin were secondary end points. The analysis was by intention to treat. Disease and survival information were collected quarterly.
RESULTS
From January 2006 to December 2014, 5,547 patients were screened to identify 1,256 with metastases in the sentinel lymph node (SLN). Of these, 483 (39%) were included: 241 in the observation arm and 242 in the CLND arm. In the final analysis, median follow up was 72 months (interquartile range, 67-77 months). No significant treatment-related difference was seen in the 5-year DMFS between the observation and CLND arms (67.6% v 64.9%, respectively; hazard ratio [HR], 1.08; P = .87). The 5-year RFS and OS also showed no difference (HR, 1.01 and 0.99, respectively). Grade 3 and 4 adverse effects occurred in 32 patients (13%) in the CLND arm; lymphedema (n = 20) and delayed wound healing (n = 5) were most common and no serious adverse events were reported.
CONCLUSION
The final results of the German Dermatologic Cooperative Oncology Group trial with a median follow up of 72 months showed higher event rates, but similar HRs compared with those at the 3-year analysis. These results confirm that immediate CLND in SLN-positive patients is not superior to observation in terms of DMFS, RFS, or OS and support not recommending CLND in patients with SLN metastasis.",2019,"These results confirm that immediate CLND in SLN-positive patients is not superior to observation in terms of DMFS, RFS, or OS and support not recommending CLND in patients with SLN metastasis.","['From January 2006 to December 2014, 5,547 patients were screened to identify 1,256 with metastases in the sentinel lymph node (SLN', 'Patients With Melanoma', 'patients with positive sentinel lymph-node biopsy', '483 (39%) were included: 241 in the observation arm and 242 in the CLND arm', 'patients with SLN metastasis', 'patients with cutaneous melanoma of the trunk and extremities who were randomly assigned (1:1) to undergo']","['CLND or observation', 'complete lymph node dissection (CLND) or observation']","['DMFS', '5-year RFS and OS', 'distant metastasis-free survival (DMFS), recurrence-free survival (RFS), and overall survival (OS', 'delayed wound healing', 'Grade 3 and 4 adverse effects', 'Disease and survival information', '5-year DMFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",5547.0,0.306993,"These results confirm that immediate CLND in SLN-positive patients is not superior to observation in terms of DMFS, RFS, or OS and support not recommending CLND in patients with SLN metastasis.","[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Leiter', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Stadler', 'Affiliation': 'Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Mauch', 'Affiliation': 'University of Köln/Bonn, Cologne, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Norbert H', 'Initials': 'NH', 'LastName': 'Brockmeyer', 'Affiliation': 'Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Berking', 'Affiliation': 'Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Cord', 'Initials': 'C', 'LastName': 'Sunderkötter', 'Affiliation': 'University of Munster, Munster, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaatz', 'Affiliation': 'SRH Wald-Klinikum Gera, Gera, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Schatton', 'Affiliation': 'University of Düsseldorf, Dusseldorf, Germany.'}, {'ForeName': 'Percy', 'Initials': 'P', 'LastName': 'Lehmann', 'Affiliation': 'HELIOS-Klinikum Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vogt', 'Affiliation': 'University of Homburg, Homburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ulrich', 'Affiliation': 'University of Magdeburg, Quedlinburg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Herbst', 'Affiliation': 'HELIOS-Klinikum Erfurt, Erfurt, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gehring', 'Affiliation': 'Carl Von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Jan-Christoph', 'Initials': 'JC', 'LastName': 'Simon', 'Affiliation': 'University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Keim', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Verver', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02306']
1487,31696504,The efficacy of a mix of three probiotic strains in reducing abdominal pain and inflammatory biomarkers in acute uncomplicated diverticulitis.,"OBJECTIVE
Acute Uncomplicated Diverticulitis (AUD) is defined as the inflammation of a colon diverticulum, often involving colic wall and pericolic fat. Conventional treatment of AUD includes antibiotics, usually ciprofloxacin and metronidazole, fasting, and fluid therapy. The aim of this study was to test the efficacy of a mix of three probiotic strains (Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302, Lactobacillus acidophilus LA 201; Lactibiane Iki®, Biocure [PiLeJe Groupe], Italy/PiLeJe Laboratoire, France) in association with conventional antibiotics in treating AUD compared to conventional antibiotics used alone.
PATIENTS AND METHODS
We enrolled 84 (25M/59F mean age 61.5 ± 11.5 years) consecutive patients who came to the Emergency Department of the Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy, with a diagnosis of AUD confirmed by CT scan. After routine blood test and dosage of C-reactive protein (C-RP), patients were randomly divided into two groups: Probiotic group (42 patients, 10M/32F mean age 32.23 ± 10.3 years) was treated with ciprofloxacin 400 mg twice a day and metronidazole 500 mg three times a day for one week and simultaneously supplemented with the probiotic mix, 1 sachet twice a day for 10 days. Control group (42 patients, 15M/27F mean age 59.01 ± 11.3 years) received the same antibiotic treatment without the probiotic mix. All patients filled a daily Visual Analog Scale (VAS) for assessment of abdominal pain, with a range value from 0 (asymptomatic) to 10, and CRP value was determined on admission and at discharge.
RESULTS
As regards abdominal pain, on Day 3, Group A showed a significant decrease of 4.06 points (51.4%) in VAS score compared to a decrease of 2.79 points (34.9%) in Group B. On Day 5 the decrease was of 6.3 points (80%) in Group A and of 4.85 points (61%) in Group B. VAS score was reduced by 7.59 points (96%) in Group A and 6.1 points (76%) in Group B on Day 7 +, and by 7.8 points (99%) in Group A and 7.2 points (90%) in Group B on Day 10. About inflammation, Group A showed a decrease in C-RP value of 64%, compared to a decrease of only 35% in Group B. We also observed that the duration of hospitalization was significantly shorter for patients in Group A: 89 h (3.7 days) in Group A vs. 101 h (4.2 days) in Group B (p=0.03).
CONCLUSIONS
Our results indicated showed that the supplement with the probiotic mix of Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302, and Lactobacillus acidophilus LA 201 in combination with the standard antibiotic therapy for AUD reduced abdominal pain and inflammation significantly more than antibiotic treatment used alone. These findings could be due to the anti-inflammatory activity of the probiotic mix. Larger studies are needed to validate its use in the clinical practice.",2019,"On Day 5 the decrease was of 6.3 points (80%) in Group A and of 4.85 points (61%) in Group B. VAS score was reduced by 7.59 points (96%) in Group A and 6.1 points (76%) in Group B on Day 7 +, and by 7.8 points (99%) in Group A and 7.2 points (90%) in Group B on Day 10.","['Control group (42 patients, 15M/27F mean age 59.01 ± 11.3 years', 'We enrolled 84 (25M/59F mean age 61.5 ± 11.5 years) consecutive patients who came to the Emergency Department of the Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy, with a diagnosis of AUD confirmed by CT scan', 'acute uncomplicated diverticulitis', 'group (42 patients, 10M/32F mean age 32.23 ± 10.3 years']","['ciprofloxacin and metronidazole, fasting, and fluid therapy', 'ciprofloxacin 400 mg twice a day and metronidazole', 'antibiotic treatment without the probiotic mix', 'mix of three probiotic strains', 'Probiotic', 'C-reactive protein (C-RP', 'probiotic strains (Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302, Lactobacillus acidophilus LA 201; Lactibiane Iki®, Biocure [PiLeJe Groupe']","['abdominal pain', 'abdominal pain and inflammation', 'C-RP value', 'daily Visual Analog Scale (VAS', 'abdominal pain and inflammatory biomarkers', 'duration of hospitalization', 'VAS score']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517519', 'cui_str': 'Ten point three'}]","[{'cui': 'C3871468', 'cui_str': 'ciprofloxacin and metronidazole'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}, {'cui': 'C0317593', 'cui_str': 'Lactobacillus salivarius'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0204159,"On Day 5 the decrease was of 6.3 points (80%) in Group A and of 4.85 points (61%) in Group B. VAS score was reduced by 7.59 points (96%) in Group A and 6.1 points (76%) in Group B on Day 7 +, and by 7.8 points (99%) in Group A and 7.2 points (90%) in Group B on Day 10.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Petruzziello', 'Affiliation': 'Emergency Department, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy. veronica.ojetti@unicatt.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marannino', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Migneco', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brigida', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saviano', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Piccioni', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Franceschi', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ojetti', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201910_19316']
1488,30707938,Effect of pre-exercise and post-exercise creatine supplementation on bone mineral content and density in healthy aging adults.,"Creatine supplementation, immediately before and immediately following resistance training, has been shown to increase muscle mass and strength. However, the effects of pre- exercise and post-exercise creatine supplementation on aging bone mineral content (BMC) and density (BMD) is unknown. Using a double-blind, repeated measures design, aging adults were randomized to one of three groups: creatine before (CR-B: n = 15; 53 ± 3 years, 170.1 ± 9.9 77.1 ± 15.6 kg; 0.1 g·kg -1 creatine immediately before resistance training and 0.1 g·kg -1 cornstarch maltodextrin immediately after resistance training), creatine after (CR-A: n = 12; 55 ± 4 years, 173.4 ± 8.3 cm, 87.9 ± 20.1 kg; 0.1 g·kg -1 cornstarch maltodextrin immediately before resistance training and 0.1 g·kg -1 of creatine immediately after resistance training), or placebo (PLA: n = 12; 57 ± 7 years, 170.5 ± 10.8 cm, 77.9 ± 11.8 kg; 0.1 g·kg -1 cornstarch maltodextrin before and after resistance training). Whole-body resistance training was performed 3 days/week for 8 months. Prior to and following training and supplementation, BMC and BMD of the whole-body, limbs, femoral neck, lumbar spine, and total hip were determined by dual-energy X-ray absorptiometry. There was a time main effect (p = 0.037) for femoral neck BMD (CR-B; absolute change: -0.011 g/cm 2 , 95% CI [-0.028, 0.006], CR-A: absolute change: -0.014 g/cm 2 , 95% CI [-0.031, 0.003], PLA: absolute change: -0.006 g/cm 2 , 95% CI [-0.002, 0.010]), with no other differences. Creatine supplementation, independent of the timing of ingestion, has no effect on aging bone mineral content or density.",2019,There was a time main effect (p = 0.037) for femoral neck BMD (CR-B; absolute change: -0.011 ,['healthy aging adults'],"['pre-exercise and post-exercise creatine supplementation', 'pre- exercise and post-exercise creatine supplementation', 'creatine before (CR-B: n\u202f=\u202f15; 53\u202f±\u202f3\u202fyears, 170.1\u202f±\u202f9.9 77.1\u202f±\u202f15.6\u202fkg; 0.1\u202fg·kg -1 creatine immediately before resistance training and 0.1\u202fg·kg -1 cornstarch maltodextrin immediately after resistance training), creatine after (CR-A: n\u202f=\u202f12; 55\u202f±\u202f4\u202fyears, 173.4\u202f±\u202f8.3\u202fcm, 87.9\u202f±\u202f20.1\u202fkg; 0.1\u202fg·kg -1 cornstarch maltodextrin immediately before resistance training and 0.1\u202fg·kg -1 of creatine immediately after resistance training), or placebo (PLA: n\u202f=\u202f12; 57\u202f±\u202f7\u202fyears, 170.5\u202f±\u202f10.8\u202fcm, 77.9\u202f±\u202f11.8\u202fkg; 0.1\u202fg·kg -1 cornstarch maltodextrin']","['femoral neck BMD', 'aging bone mineral content (BMC) and density (BMD', 'bone mineral content and density', 'aging bone mineral content or density']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517523', 'cui_str': '10.8'}]","[{'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",,0.169795,There was a time main effect (p = 0.037) for femoral neck BMD (CR-B; absolute change: -0.011 ,"[{'ForeName': 'Darren G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK, Canada. Electronic address: Darren.Candow@uregina.ca.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education, Faculty of Education, Brandon University, Brandon, MB, Canada.'}, {'ForeName': 'Emelie', 'Initials': 'E', 'LastName': 'Vogt', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK, Canada.'}]",Experimental gerontology,['10.1016/j.exger.2019.01.025']
1489,32408166,Using immersive virtual reality to modify body image.,"We tested the efficacy of a training programme, delivered in virtual reality (VR), to modify the perceptual boundary between what participants classify as a fat versus a thin body. Three cohorts of 20 female volunteers with high body image concerns were recruited to two intervention groups and one control group. All participants completed a 4-day training programme in VR where they categorised a series of 3D models as either thin or fat; one intervention group was presented with the stimuli briefly, while the other group had no time limits imposed. Both intervention groups were given inflationary feedback to shift their categorisations of the stimulus models towards higher BMIs. Our results show that, compared to controls, both intervention groups shifted their categorical boundaries between Day 1 and follow-up on Day 14. Unlimited stimulus presentation times were associated with a larger training effect. Furthermore, both intervention groups experienced statistically significant reductions in their concerns about their own body shape, weight and eating habits. However, only in the group with longer stimulus presentation times were these reductions consistent with a clinically meaningful effect. These findings suggest that manipulating categorical perception in VR might provide a complementary addition to existing treatments for eating disorders.",2020,"Our results show that, compared to controls, both intervention groups shifted their categorical boundaries between Day 1 and follow-up on Day 14.",['20 female volunteers with high body image concerns'],"['training programme, delivered in virtual reality (VR', '4-day training programme']","['body shape, weight and eating habits']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",20.0,0.01014,"Our results show that, compared to controls, both intervention groups shifted their categorical boundaries between Day 1 and follow-up on Day 14.","[{'ForeName': 'Kamila R', 'Initials': 'KR', 'LastName': 'Irvine', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK. Electronic address: kirvine@lincoln.ac.uk.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Irvine', 'Affiliation': 'Virtual Research Innovations Ltd., UK; School of Psychology, College of Social Science, University of Lincoln, Lincolnshire, LN6 7TS, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Maalin', 'Affiliation': 'School of Psychology, College of Social Science, University of Lincoln, Lincolnshire, LN6 7TS, UK.'}, {'ForeName': 'Kristofor', 'Initials': 'K', 'LastName': 'McCarty', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}, {'ForeName': 'Katri K', 'Initials': 'KK', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Tovée', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}, {'ForeName': 'Piers L', 'Initials': 'PL', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Psychology, Faculty of health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.'}]",Body image,['10.1016/j.bodyim.2020.03.007']
1490,30720560,The HIP LADIES: A Pilot Health Improvement Project for HIV Prevention in Black College Women.,"A disproportionate number of new HIV infections in the United States occur in Black women. We pilot-tested feasibility and acceptability of a manualized HIV prevention intervention developed with and for Black college women. We used a prospective, randomized 2-group design, with 3 data collection times. Participants included 18- to 24-year-old Black women (N = 65), who were enrolled at 2 southern universities; 46 completed pre- and post-assessments. We found that participants in the intervention arm had positive changes in HIV knowledge (p < .0001) and behavioral intentions (p = .039) outcomes. There were, however, no significant differences between intervention and control groups when considering motivational factors and behavioral skills that promoted HIV prevention: social norms, condom use self-efficacy, and assertive sexual communication. We found preliminary evidence of efficacy for an HIV prevention intervention tailored to Black college women. Researchers should partner with Black college women to develop and implement HIV prevention interventions.",2019,We found that participants in the intervention arm had positive changes in HIV knowledge (p < .0001) and behavioral intentions (p = .039) outcomes.,"['Black women', 'Participants included 18- to 24-year-old Black women (N = 65), who were enrolled at 2 southern universities; 46 completed pre- and post-assessments', 'Black College Women', 'Black college women']","['manualized HIV prevention intervention', 'HIV prevention intervention']","['behavioral intentions', 'motivational factors and behavioral skills that promoted HIV prevention: social norms, condom use self-efficacy, and assertive sexual communication', 'positive changes in HIV knowledge']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",65.0,0.0308477,We found that participants in the intervention arm had positive changes in HIV knowledge (p < .0001) and behavioral intentions (p = .039) outcomes.,"[{'ForeName': 'Rasheeta', 'Initials': 'R', 'LastName': 'Chandler', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ross', 'Affiliation': ''}, {'ForeName': 'Sudeshna', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': ''}, {'ForeName': 'Adedoyin', 'Initials': 'A', 'LastName': 'Shittu', 'Affiliation': ''}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Lescano', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Hernandez', 'Affiliation': ''}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Morrison-Beedy', 'Affiliation': ''}]",The Journal of the Association of Nurses in AIDS Care : JANAC,['10.1097/JNC.0000000000000058']
1491,30720579,Transcutaneous Neuromodulation at ST36 (Zusanli) is More Effective than Transcutaneous Tibial Nerve Stimulation in Treating Constipation.,"BACKGROUND AND GOALS
Combined transcutaneous neuromodulation (TN) at acupoint ST36 (Zusanli) and TN at the posterior tibial nerve (PTN) has been reported effective in treating functional constipation. This study was designed to compare the effectiveness of TN between these 2 points.
MATERIALS AND METHODS
Eighteen functional constipation patients (M/F: 9/9) were recruited to participate in a cross-over study with a 2-week TN at ST36 and a 2-week TN at PTN. A bowel movement diary, and the questionnaires of Patient Assessment of Constipation Symptom (PAC-SYM) and Constipation Quality of Life (PAC-QoL) were completed; anorectal manometry and spectral analysis of heart rate variability for assessing the autonomic function were performed.
RESULTS
(1) Both TN at ST36 and TN at PTN improved constipation-related symptoms (PAC-SYM scores on pre-TN vs. post-TN: 1.4±0.1 vs. 0.6±0.1 for ST36, 1.4±0.1 vs. 0.9±0.1 for PTN, both P≤0.001). (2) TN at ST36, but not TN at PTN, increased the number of weekly spontaneous bowel movements (0.9±0.2 pre-TN vs. 3.5±0.7 post-TN, P<0.001) and decreased the total PAC-QoL score. TN at ST36 was more potent than TN at PTN in improving the PAC-SYM score (decrement 0.8±0.1 vs. 0.5±0.1, P<0.05). (3) TN at ST36 rather than TN at PTN resulted in a reduction in sensation thresholds, including rectal distention for urge (134.1±14.3 mL pre-TN vs. 85.6±6.5 mL post-TN, P<0.01) and maximum tolerance (P<0.05). (4) Both TN at ST36 and TN at PTN significantly increased vagal activity and decreased sympathetic activity (P<0.05).
CONCLUSIONS
TN at ST36 is more potent than TN at PTN in treating constipation and improving constipation-related symptoms and rectal sensation.",2020,"Both TN at ST36 and TN at PTN significantly increased vagal activity and decreased sympathetic activity (P<0.05).
",['Eighteen functional constipation patients (M/F: 9/9) were recruited to participate in a cross-over study with a 2-week TN at ST36 and a 2-week TN at PTN'],"['Transcutaneous Neuromodulation at ST36 (Zusanli', 'transcutaneous neuromodulation (TN) at acupoint ST36 (Zusanli) and TN at the posterior tibial nerve (PTN', 'Transcutaneous Tibial Nerve Stimulation']","['total PAC-QoL score', 'constipation-related symptoms (PAC-SYM scores', 'number of weekly spontaneous bowel movements', 'sensation thresholds, including rectal distention for urge', 'PAC-SYM score', 'questionnaires of Patient Assessment of Constipation Symptom (PAC-SYM) and Constipation Quality of Life (PAC-QoL', 'vagal activity and decreased sympathetic activity']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0450533', 'cui_str': 'ST36 (body structure)'}]","[{'cui': 'C0450533', 'cui_str': 'ST36 (body structure)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034380'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",18.0,0.0186976,"Both TN at ST36 and TN at PTN significantly increased vagal activity and decreased sympathetic activity (P<0.05).
","[{'ForeName': 'Gao-Jue', 'Initials': 'GJ', 'LastName': 'Wu', 'Affiliation': 'Ningbo Pace Translational Medical Research Center, Beilun.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, Ningbo Yinzhou People's Hospital, Ningbo, Zhejiang.""}, {'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Sun', 'Affiliation': 'Ningbo Pace Translational Medical Research Center, Beilun.'}, {'ForeName': 'Jiande D Z', 'Initials': 'JDZ', 'LastName': 'Chen', 'Affiliation': 'Ningbo Pace Translational Medical Research Center, Beilun.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001184']
1492,30718072,"Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND
VEGF and VEGF receptor 2 (VEGFR-2)-mediated signalling and angiogenesis can contribute to the pathogenesis and progression of gastric cancer. We aimed to assess whether the addition of ramucirumab, a VEGFR-2 antagonist monoclonal antibody, to first-line chemotherapy improves outcomes in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma.
METHODS
For this double-blind, randomised, placebo-controlled, phase 3 trial done at 126 centres in 20 countries, we recruited patients aged 18 years or older with metastatic, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function. Eligible patients were randomly assigned (1:1) with an interactive web response system to receive cisplatin (80 mg/m 2 , on the first day) plus capecitabine (1000 mg/m 2 , twice daily for 14 days), every 21 days, and either ramucirumab (8 mg/kg) or placebo on days 1 and 8, every 21 days. 5-Fluorouracil (800 mg/m 2 intravenous infusion on days 1-5) was permitted in patients unable to take capecitabine. The primary endpoint was investigator-assessed progression-free survival, analysed by intention to treat in the first 508 patients. We did a sensitivity analysis of the primary endpoint, including a central review of CT scans. Overall survival was a key secondary endpoint. This study is registered with ClinicalTrials.gov, number NCT02314117.
FINDINGS
Between Jan 28, 2015, and Sept 16, 2016, 645 patients were randomly assigned to receive ramucirumab plus fluoropyrimidine and cisplatin (n=326) or placebo plus fluoropyrimidine and cisplatin (n=319). Investigator-assessed progression-free survival was significantly longer in the ramucirumab group than the placebo group (hazard ratio [HR] 0·753, 95% CI 0·607-0·935, p=0·0106; median progression-free survival 5·7 months [5·5-6·5] vs 5·4 months [4·5-5·7]). A sensitivity analysis based on central independent review of the radiological images did not corroborate the investigator-assessed difference in progression-free survival (HR 0·961, 95% CI 0·768-1·203, p=0·74). There was no difference in overall survival between groups (0·962, 0·801-1·156, p=0·6757; median overall survival 11·2 months [9·9-11·9] in the ramucirumab group vs 10·7 months [9·5-11·9] in the placebo group). The most common grade 3-4 adverse events were neutropenia (85 [26%] of 323 patients in the ramucirumab group vs 85 [27%] of 315 in the placebo group), anaemia (39 [12%] vs 44 [14%]), and hypertension (32 [10%] vs 5 [2%]). The incidence of any-grade serious adverse events was 160 (50%) of 323 patients in the ramucirumab group and 149 (47%) of 315 patients in the placebo group. The most common serious adverse events were vomiting (14 [4%] in the ramucirumab group vs 21 [7%] in the placebo group) and diarrhoea (11 [3%] vs 19 [6%]). There were seven deaths in each group, either during study treatment or within 30 days of discontinuing study treatment, which were the result of treatment-related adverse events. In the ramucirumab group, these adverse events were acute kidney injury, cardiac arrest, gastric haemorrhage, peritonitis, pneumothorax, septic shock, and sudden death (n=1 of each). In the placebo group, these adverse events were cerebrovascular accident (n=1), multiple organ dysfunction syndrome (n=2), pulmonary embolism (n=2), sepsis (n=1), and small intestine perforation (n=1).
INTERPRETATION
Although the primary analysis for progression-free survival was statistically significant, this outcome was not confirmed in a sensitivity analysis of progression-free survival by central independent review, and did not improve overall survival. Therefore, the addition of ramucirumab to cisplatin plus fluoropyrimidine chemotherapy is not recommended as first-line treatment for this patient population.
FUNDING
Eli Lilly and Company.",2019,"There was no difference in overall survival between groups (0·962, 0·801-1·156, p=0·6757; median overall survival 11·2 months [9·9-11·9] in the ramucirumab group vs 10·7 months [9·5-11·9] in the placebo group).","['Between Jan 28, 2015, and Sept 16, 2016', 'patients with metastatic gastric or junctional adenocarcinoma (RAINFALL', '645 patients', 'Eligible patients', 'patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma', '126 centres in 20 countries, we recruited patients aged 18 years or older with metastatic, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function']","['ramucirumab plus fluoropyrimidine and cisplatin (n=326) or placebo plus fluoropyrimidine and cisplatin', 'cisplatin plus fluoropyrimidine chemotherapy', 'placebo', 'interactive web response system to receive cisplatin', 'ramucirumab', 'capecitabine', 'ramucirumab, a VEGFR-2 antagonist monoclonal antibody, to first-line chemotherapy', 'Ramucirumab with cisplatin and fluoropyrimidine', '5-Fluorouracil']","['incidence of any-grade serious adverse events', 'anaemia', 'vomiting', 'Investigator-assessed progression-free survival', 'progression-free survival', 'hypertension', 'Overall survival', 'diarrhoea', 'neutropenia', 'adverse events were cerebrovascular accident (n=1), multiple organ dysfunction syndrome (n=2), pulmonary embolism (n=2), sepsis (n=1), and small intestine perforation (n=1', 'adverse events were acute kidney injury, cardiac arrest, gastric haemorrhage, peritonitis, pneumothorax, septic shock, and sudden death (n=1 of each', 'investigator-assessed progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0378796', 'cui_str': 'Flk-1 Protein'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0151739', 'cui_str': 'Perforation of small intestine (disorder)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0235325', 'cui_str': 'Gastric hemorrhage (disorder)'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}]",645.0,0.773776,"There was no difference in overall survival between groups (0·962, 0·801-1·156, p=0·6757; median overall survival 11·2 months [9·9-11·9] in the ramucirumab group vs 10·7 months [9·5-11·9] in the placebo group).","[{'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, Smilow Cancer Hospital, New Haven, CT, USA. Electronic address: charles.fuchs@yale.edu.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Institute of Clinical Cancer Research at Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Gasthuisberg, Leuven and KULeuven, Belgium.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Royal Marsden Hospital, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Lacy', 'Affiliation': 'Yale Cancer Center, Smilow Cancer Hospital, New Haven, CT, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': 'Gustave Roussy Cancer Centre, Grand Paris, Villejuif, France; Université Paris-Saclay, France.'}, {'ForeName': 'Guillermo Ariel', 'Initials': 'GA', 'LastName': 'Mendez', 'Affiliation': 'Hospital Universitario Fundacion Favaloro, Buenos Aires, Argentina.'}, {'ForeName': 'Alejandro Molina', 'Initials': 'AM', 'LastName': 'Alavez', 'Affiliation': 'Center for Clinical Care and Research in Oncology, Merida, Yucatan, Mexico.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Takahari', 'Affiliation': 'The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Enzinger', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Gorbounova', 'Affiliation': 'N N Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Hegewisch-Becker', 'Affiliation': 'HOPE-Practice for Oncology, Hamburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ferry', 'Affiliation': 'Eli Lilly and Company, New York City, NY, USA.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carlesi', 'Affiliation': 'Eli Lilly Italia, Florence, Italy.'}, {'ForeName': 'Mayukh', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Manish A', 'Initials': 'MA', 'LastName': 'Shah', 'Affiliation': 'Weill Cornell Medical College, NY, USA; New York Presbyterian Hospital, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30791-5']
1493,30680830,Synergy of pulmonary vein isolation and catheter renal denervation in atrial fibrillation complicated with uncontrolled hypertension: Mapping the renal sympathetic nerve and pulmonary vein (the pulmonary vein isolation plus renal denervation strategy)?,"INTRODUCTION
Disturbance of sympathetic and vagal nervous system participates in the pathogenesis of hypertension and atrial fibrillation (AF). Renal denervation (RDN) can modulate autonomic nervous activity and reduce blood pressure (BP) in hypertensive patients. We aimed to evaluate the effect of RDN combined with pulmonary vein isolation (PVI) in patients with AF and hypertension.
METHODS
Clinical trials including randomized data comparing PVI plus RDN vs PVI alone were enrolled. Primary outcome was incidence of AF recurrence after procedure.
RESULTS
A total of 387 patients, of them 252 were randomized and were enrolled. Mean age was 57 ± 10 years, 71% were male, and mean left ventricular ejection fraction was 57.4% ± 6.9%. Follow-up for randomized data was 12 months. Overall comparison for primary outcome showed that PVI + RDN was associated with significantly lower AF recurrence as compared with PVI alone (35.8% vs 55.4%, P < 0.0001). This advantageous effect was consistently maintained among randomized patients (37.3% vs 61.9%, odds ratio = 0.37, P = 0.0001), and among patients with implanted devices for detection of AF recurrence (38.9% vs 61.6%, P = 0.007). Post-hoc sensitivity and regression analysis demonstrated very good stability of this primary result. Pooled Kaplan-Meier analysis further showed that PVI + RDN was associated with significantly higher freedom from AF recurrence as compared with PVI alone (log-rank test, P = 0.001). Besides, RDN resulted in significant BP reduction without additionally increasing the risk of adverse events.
CONCLUSIONS
RDN may provide synergetic effects with PVI to reduce the burden of AF and improve BP control in patients with AF and uncontrolled hypertension.",2019,"Pooled Kaplan-Meier analysis further showed that PVI + RDN was associated with significantly higher freedom from AF recurrence as compared with PVI alone (log-rank test, P = 0.001).","['Mean age was 57\u2009±\u200910 years, 71% were male, and mean left ventricular ejection fraction was 57.4%\u2009±\u20096.9', 'hypertensive patients', 'A total of 387 patients, of them 252 were randomized and were enrolled', 'patients with AF and hypertension', 'atrial fibrillation complicated with uncontrolled hypertension', 'patients with AF and uncontrolled hypertension']","['pulmonary vein isolation and catheter renal denervation', 'PVI plus RDN vs PVI alone', 'RDN combined with pulmonary vein isolation (PVI', 'Renal denervation (RDN']","['burden of AF and improve BP control', 'risk of adverse events', 'BP reduction', 'AF recurrence', 'PVI\u2009+\u2009RDN', 'blood pressure (BP', 'incidence of AF recurrence after procedure']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period (qualifier value)'}]",387.0,0.129155,"Pooled Kaplan-Meier analysis further showed that PVI + RDN was associated with significantly higher freedom from AF recurrence as compared with PVI alone (log-rank test, P = 0.001).","[{'ForeName': 'Shaojie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Frankfurt Academy For Arrhythmias (FAFA), Medizinische Klinik III, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'Marcio G', 'Initials': 'MG', 'LastName': 'Kiuchi', 'Affiliation': 'School of Medicine-Royal Perth Hospital Unit, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Yuehui', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Cardiology, Chongqing Cardiac Arrhythmia Service Center, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Shaowen', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shanghai First People's Hospital/Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schratter', 'Affiliation': 'Medizinische Abteilung mit Kardiologie, Krankenhaus Hietzing Wien, Vienna, Austria.'}, {'ForeName': 'Willem-Jan', 'Initials': 'WJ', 'LastName': 'Acou', 'Affiliation': 'Department of Cardiology, AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Klinik für Kardiologie mit Schwerpunkt Elektrophysiologie, Universitäres Herzzentrum Hamburg, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Pürerfellner', 'Affiliation': 'Abteilung der kardialen Elektrophysiologie/Kardiologie, Akademisches Lehrkrankenhaus der Elisabethinen, Ordensklinikum Linz Elisabethinen, Linz, Austria.'}, {'ForeName': 'K R Julian', 'Initials': 'KRJ', 'LastName': 'Chun', 'Affiliation': 'Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Frankfurt Academy For Arrhythmias (FAFA), Medizinische Klinik III, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Schmidt', 'Affiliation': 'Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Frankfurt Academy For Arrhythmias (FAFA), Medizinische Klinik III, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13858']
1494,31560580,"Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis.","PURPOSE
Many older women will be treated with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and an aromatase inhibitor (AI), given US Food and Drug Administration approval of three agents in this class. The current pooled analysis examines the efficacy and safety of this combination in older women.
PATIENTS AND METHODS
We pooled data from three randomized controlled studies (N = 1,827) of different CDK4/6 inhibitors in combination with an AI for initial treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. The effect of age on progression-free survival was evaluated using Kaplan-Meier estimates and a Cox proportional hazards regression model.
RESULTS
For patients age 75 years or older (n = 198) who were treated with a CDK4/6 inhibitor and an AI, hazard ratio was 0.49 (95% CI, 0.31 to 0.76) with an estimated median progression-free survival of 31.1 months (95% CI, 20.2 months to not reached) versus 13.7 months (95% CI, 10.9 months to 24.9 months) for those treated with an AI. Incidence of grade 3 to 4 adverse events was 88.8% in patients age 75 years and older and 73.4% in patients younger than age 75 years. Patients age 75 years or older reported a decline in quality-of-life measures using the EQ-5D regardless of treatment with AI alone or with the addition of a CDK4/6 inhibitor.
CONCLUSION
There was similar efficacy with a CDK4/6 inhibitor in combination with an AI compared with AI alone for first-line treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer in older women compared with younger patients. Patients older than age 75 years experienced higher rates of toxicity, dose modifications, and a decrease from baseline in quality-of-life measures.",2019,"Patients age 75 years or older reported a decline in quality-of-life measures using the EQ-5D regardless of treatment with AI alone or with the addition of a CDK4/6 inhibitor.
","['For patients age 75 years or older (n = 198) who were treated with a', 'Patients older than age 75 years', 'postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer', 'Patients age 75 years or older', 'older women', 'Older Women With', 'We pooled data from three randomized controlled studies (N = 1,827) of different']","['CDK4/6 inhibitors in combination with an AI', 'CDK4/6 Inhibitor and an Aromatase Inhibitor', 'cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and an aromatase inhibitor (AI', 'CDK4/6 inhibitor']","['quality-of-life measures', 'progression-free survival', 'efficacy and safety', 'median progression-free survival', 'rates of toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}]","[{'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0653491,"Patients age 75 years or older reported a decline in quality-of-life measures using the EQ-5D regardless of treatment with AI alone or with the addition of a CDK4/6 inhibitor.
","[{'ForeName': 'Lynn J', 'Initials': 'LJ', 'LastName': 'Howie', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Wedam', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Tatiana M', 'Initials': 'TM', 'LastName': 'Prowell', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Belinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Theoret', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02217']
1495,30665869,"Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND
Patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations have poor prognosis. We aimed to establish the efficacy of ramucirumab in patients with advanced hepatocellular carcinoma and α-fetoprotein concentrations of 400 ng/mL or higher.
METHODS
REACH-2 was a randomised, double-blind, placebo-controlled, phase 3 trial done at 92 hospitals, clinics, and medical centres in 20 countries. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed hepatocellular carcinoma, or diagnosed cirrhosis and hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage B or C disease, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group (ECOG) performance statuses of 0 or 1, α-fetoprotein concentrations of 400 ng/mL or greater, and had previously received first-line sorafenib. Participants were randomly assigned (2:1) via an interactive web response system with a computer-generated random sequence to 8 mg/kg intravenous ramucirumab every 2 weeks or placebo. All patients received best supportive care. The primary endpoint was overall survival. Secondary endpoints were progression-free survival, proportion of patients achieving an objective response, time to radiographic progression, safety, time to deterioration in scores on the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8), and time to deterioration in ECOG performance status. We also pooled individual patient data from REACH-2 with data from REACH (NCT01140347) for patients with α-fetoprotein concentrations of 400 ng/mL or greater. Efficacy analyses were by intention to treat, whereas safety analyses were done in all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02435433.
FINDINGS
Between July 26, 2015, and Aug 30, 2017, 292 patients were randomly assigned, 197 to the ramucirumab group and 95 to the placebo group. At a median follow-up of 7·6 months (IQR 4·0-12·5), median overall survival (8·5 months [95% CI 7·0-10·6] vs 7·3 months [5·4-9·1]; hazard ratio [HR] 0·710 [95% CI 0·531-0·949]; p=0·0199) and progression-free survival (2·8 months [2·8-4·1] vs 1·6 months [1·5-2·7]; 0·452 [0·339-0·603]; p<0·0001) were significantly improved in the ramucirumab group compared with the placebo group. The proportion of patients with an objective response did not differ significantly between groups (nine [5%] of 197 vs one [1%] of 95; p=0·1697). Median time to deterioration in FHSI-8 total scores (3·7 months [95% CI 2·8-4·4] vs 2·8 months [1·6-2·9]; HR 0·799 [95% CI 0·545-1·171]; p=0·238) and ECOG performance statuses (HR 1·082 [95% CI 0·639-1·832]; p=0·77) did not differ between groups. Grade 3 or worse treatment-emergent adverse events that occurred in at least 5% of patients in either group were hypertension (25 [13%] in the ramucirumab group vs five [5%] in the placebo group), hyponatraemia (11 [6%] vs 0) and increased aspartate aminotransferase (six [3%] vs five [5%]). Serious adverse events of any grade and cause occurred in 68 (35%) patients in the ramucirumab group and 28 (29%) patients in the placebo group. Three patients in the ramucirumab group died from treatment-emergent adverse events that were judged to be related to study treatment (one had acute kidney injury, one had hepatorenal syndrome, and one had renal failure).
INTERPRETATION
REACH-2 met its primary endpoint, showing improved overall survival for ramucirumab compared with placebo in patients with hepatocellular carcinoma and α-fetoprotein concentrations of at least 400 ng/mL who had previously received sorafenib. Ramucirumab was well tolerated, with a manageable safety profile. To our knowledge, REACH-2 is the first positive phase 3 trial done in a biomarker-selected patient population with hepatocellular carcinoma.
FUNDING
Eli Lilly.",2019,Median time to deterioration in FHSI-8 total scores (3·7 months [95% CI 2·8-4·4] vs 2·8 months [1·6-2·9]; HR 0·799 [95% CI 0·545-1·171]; p=0·238) and ECOG performance statuses (HR 1·082 [95% CI 0·639-1·832]; p=0·77) did not differ between groups.,"['Between July 26, 2015, and Aug 30, 2017, 292 patients were randomly assigned, 197 to the ramucirumab group and 95 to the', 'patients with advanced hepatocellular carcinoma and α-fetoprotein concentrations of 400 ng/mL or higher', 'Patients with advanced hepatocellular carcinoma', 'patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2', 'patient population with hepatocellular carcinoma', '92 hospitals, clinics, and medical centres in 20 countries', 'Eligible patients were aged 18 years or older and had histologically or cytologically confirmed hepatocellular carcinoma, or diagnosed cirrhosis and hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage B or C disease, Child']","['placebo', 'ramucirumab', 'Pugh class', 'Ramucirumab after sorafenib', 'Ramucirumab', 'sorafenib', 'interactive web response system with a computer-generated random sequence to 8 mg/kg intravenous ramucirumab every 2 weeks or placebo']","['ECOG performance statuses', 'aspartate aminotransferase', 'Median time to deterioration in FHSI-8 total scores', 'proportion of patients with an objective response', 'hyponatraemia', 'progression-free survival', 'hypertension', 'renal failure', 'Grade 3 or worse treatment-emergent adverse events', 'progression-free survival, proportion of patients achieving an objective response, time to radiographic progression, safety, time to deterioration in scores on the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8), and time to deterioration in ECOG performance status', 'median overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0015950', 'cui_str': 'Fetoprotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C0441781', 'cui_str': 'Stage B (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",292.0,0.756414,Median time to deterioration in FHSI-8 total scores (3·7 months [95% CI 2·8-4·4] vs 2·8 months [1·6-2·9]; HR 0·799 [95% CI 0·545-1·171]; p=0·238) and ECOG performance statuses (HR 1·082 [95% CI 0·639-1·832]; p=0·77) did not differ between groups.,"[{'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard Medical Center, Boston, MA, USA. Electronic address: azhu@mgh.harvard.edu.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital Tainan, Taiwan; College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'University Medical Center, Mainz, Germany.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': ""Icahn School of Medicine at Mount Sinai, New York, NY, USA; Institut d'Investigations Biomèdiques, August Pi i Sunyer-Hospital Clinic Barcelona, Barcelona, Spain.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Assenat', 'Affiliation': 'CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'University Hospital S Orsola, Bologna, Italy.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pracht', 'Affiliation': 'Centre Eugene Marquis, Rennes, France.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Kun-Ming', 'Initials': 'KM', 'LastName': 'Rau', 'Affiliation': 'Chang Gung Memorial Hospital-Kaohsiung Branch, Kaohsiung City, Taiwan; Hematology-Oncology Department, E-Da Cancer Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Aso Iizuka Hospital-Hepatology, Iizuka, Fukuoka, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Ohno', 'Affiliation': 'National Cancer Center Hospital East-Hepatobiliary and Pancreatic Oncology, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Azienda Ospedaliera G Rummo, Benevento, Benevento, Italy; Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Dong Bok', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gerken', 'Affiliation': 'Universtitätsklinikum Essen AöR, Essen, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Hiriart', 'Affiliation': 'CHU de Bordeaux, Pessac, France.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'Eli Lilly, New York, NY, USA.'}, {'ForeName': 'Paolo B', 'Initials': 'PB', 'LastName': 'Abada', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Kindai University, Osaka-Sayama, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30937-9']
1496,30711522,"Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial.","BACKGROUND
To our knowledge, no randomised study has compared postmastectomy hypofractionated radiotherapy with conventional fractionated radiotherapy in patients with breast cancer. This study aimed to determine whether a 3-week schedule of postmastectomy hypofractionated radiotherapy is as efficacious and safe as a 5-week schedule of conventional fractionated radiotherapy.
METHODS
This randomised, non-inferiority, open-label, phase 3 study was done in a single academic hospital in China. Patients aged 18-75 years who had undergone mastectomy and had at least four positive axillary lymph nodes or primary tumour stage T3-4 disease were eligible to participate. Patients were randomly assigned (1:1) according to a computer-generated central randomisation schedule, without stratification, to receive chest wall and nodal irradiation at a dose of 50 Gy in 25 fractions over 5 weeks (conventional fractionated radiotherapy) or 43·5 Gy in 15 fractions over 3 weeks (hypofractionated radiotherapy). The modified intention-to-treat population (including all eligible patients who underwent randomisation but excluding those who were considered ineligible or withdrew consent after randomisation) was used in primary and safety analyses. The primary endpoint was 5-year locoregional recurrence, and a 5% margin was used to establish non-inferiority (equivalent to a hazard ratio <1·883). This trial is registered at ClinicalTrials.gov, number NCT00793962.
FINDINGS
Between June 12, 2008, and June 16, 2016, 820 patients were enrolled and randomly assigned to the conventional fractionated radiotherapy group (n=414) or hypofractionated radiotherapy group (n=406). 409 participants in the conventional fractionated radiotherapy group and 401 participants in the hypofractionated radiotherapy group were included in the modified intention-to-treat analyses. At a median follow-up of 58·5 months (IQR 39·2-81·8), 60 (7%) patients had developed locoregional recurrence (31 patients in the hypofractionated radiotherapy group and 29 in the conventional fractionated radiotherapy group); the 5-year cumulative incidence of locoregional recurrence was 8·3% (90% CI 5·8-10·7) in the hypofractionated radiotherapy group and 8·1% (90% CI 5·4-10·6) in the conventional fractionated radiotherapy group (absolute difference 0·2%, 90% CI -3·0 to 2·6; hazard ratio 1·10, 90% CI 0·72 to 1·69; p<0·0001 for non-inferiority). There were no significant differences between the groups in acute and late toxicities, except that fewer patients in the hypofractionated radiotherapy group had grade 3 acute skin toxicity than in the conventional fractionated radiotherapy group (14 [3%] of 401 patients vs 32 [8%] of 409 patients; p<0·0001).
INTERPRETATION
Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer. Hypofractionated radiotherapy could provide more convenient treatment and allow providers to treat more patients.
FUNDING
National Key Projects of Research and Development of China; the Chinese Academy of Medical Science Innovation Fund for Medical Sciences; and Beijing Marathon of Hope, Cancer Foundation of China.",2019,"INTERPRETATION
Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer.","['409 participants in the conventional fractionated radiotherapy group and 401 participants in the', 'Patients aged 18-75 years who had undergone mastectomy and had at least four positive axillary lymph nodes or primary tumour stage T3-4 disease were eligible to participate', 'patients with high-risk breast cancer', 'Between June 12, 2008, and June 16, 2016, 820 patients', 'single academic hospital in China', '0·72 to 1·69', 'patients with breast cancer']","['postmastectomy hypofractionated radiotherapy', 'conventional fractionated radiotherapy', 'postmastectomy hypofractionated radiotherapy with conventional fractionated radiotherapy', 'hypofractionated radiotherapy', 'computer-generated central randomisation schedule, without stratification, to receive chest wall and nodal irradiation at a dose of 50 Gy in 25 fractions over 5 weeks (conventional fractionated radiotherapy) or 43·5 Gy in 15 fractions over 3 weeks (hypofractionated radiotherapy', 'Hypofractionated radiotherapy', 'Hypofractionated versus conventional fractionated postmastectomy radiotherapy', 'Postmastectomy hypofractionated radiotherapy']","['5-year locoregional recurrence', 'acute and late toxicities', 'locoregional recurrence', '5-year cumulative incidence of locoregional recurrence', 'grade 3 acute skin toxicity']","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node structure (body structure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475374', 'cui_str': 'Tumor stage T3'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",820.0,0.183781,"INTERPRETATION
Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer.","[{'ForeName': 'Shu-Lian', 'Initials': 'SL', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yong-Wen', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei-Hu', 'Initials': 'WH', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xin-Fan', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zi-Hao', 'Initials': 'ZH', 'LastName': 'Yu', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ning-Ning', 'Initials': 'NN', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shu-Nan', 'Initials': 'SN', 'LastName': 'Qi', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guang-Yi', 'Initials': 'GY', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Peng', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ye-Xiong', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Molecular Oncology and Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: yexiong12@163.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30813-1']
1497,31651801,IV Ibuprofen for Prevention of Post-ERCP Pancreatitis in Children: A Randomized Placebo-controlled Feasibility Study.,"BACKGROUND
Post-endoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis (PEP) is reported to occur in up to 11% of pediatric patients. To date, no study has prospectively evaluated an intervention to prevent PEP in children. It is unclear if such a study is even feasible.
OBJECTIVE
The aim of the study was to evaluate the feasibility of studying IV ibuprofen for PEP prevention in the pediatric population.
METHODS
This was a prospective randomized double-blind placebo-controlled feasibility study. Patients younger than 19 years of age undergoing ERCP were randomized to receive 10 mg/kg IV ibuprofen (max of 800 mg) or placebo (saline) at the time of ERCP. The primary outcome was PEP. Secondary outcomes included post-ERCP-related bleeding, rates of other procedural and medication-related adverse events.
RESULTS
Fifty-eight patients were randomized and received either IV ibuprofen or placebo. Preprocedure- and procedure-related factors were not significantly different between the groups except that patients in the placebo group tended to weigh less (48.7 vs 63.7 kg, P = 0.03). There were 7 episodes of PEP (12%). PEP was less frequently identified in the Ibuprofen group than in the control group (7% vs 17%), but this was not statistically significant (P = 0.42). Mean postprocedural abdominal pain scores were significantly lower in the IV Ibuprofen group than in the control group (1.1 vs 3.1, P = 0.01) and the number of patients who had increased abdominal pain after the procedure was significantly lower in ibuprofen group than in the control group (3% vs 38%, P = 0.002). There were no significant differences in procedure-related or drug-related adverse events.
CONCLUSIONS
Postprocedural pain scores and the number of patients who had increased abdominal pain after the procedure were significantly lower in the IV ibuprofen group. The current study provides encouraging, but only very weak evidence that IV ibuprofen decreases PEP in children. Power analysis suggests that a small handful of high-volume pediatric centers would be able to perform an adequate clinical trial in a reasonable time frame. Focusing on all cause postprocedural pain (PEP and non-PEP) may allow for a more efficiency study design and be just as clinically relevant.",2020,"procedure and procedure related factors were not significantly different between the groups except that patients in the placebo group tended to weigh less (48.7 kg vs 63.7 kg, p = 0.03).","['children', 'Patients < 19 years of age undergoing ERCP', '58 patients', 'Children']","['Placebo', 'IV Ibuprofen or placebo', 'IV Ibuprofen', 'ibuprofen', 'Ibuprofen (max of 800\u200amg) or placebo (saline', 'placebo', 'Ibuprofen']","['Mean post-procedural abdominal pain scores', 'PEP', 'abdominal pain', 'post-ERCP related bleeding, rates of other procedural and medication related adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",58.0,0.404517,"procedure and procedure related factors were not significantly different between the groups except that patients in the placebo group tended to weigh less (48.7 kg vs 63.7 kg, p = 0.03).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Troendle', 'Affiliation': 'UT Southwestern Medical Center.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Gurram', 'Affiliation': 'UT Southwestern Medical Center.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ""Children's Health Children's Medical Center, Dallas, TX.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Barth', 'Affiliation': 'UT Southwestern Medical Center.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002524']
1498,30707049,Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials.,"Background: Flibanserin, a 5-hydroxytryptamine 5-HT 1A agonist and 5-HT 2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis assessed pooled efficacy and safety data for flibanserin in premenopausal women with HSDD. Materials and Methods: Data for flibanserin 100 mg once daily at bedtime (qhs) and placebo were pooled from three pivotal 24-week, randomized, placebo-controlled, multicenter studies (VIOLET, DAISY, and BEGONIA) of premenopausal women with HSDD. Pooled efficacy endpoints included the change from baseline to study end ( i.e ., 24 weeks) in the number of satisfying sexual events (SSEs) over 28 days, the Female Sexual Function Index desire domain (FSFI-d) score, and the Female Sexual Distress Scale-Revised Item 13 (FSDS-R-13) score. Results: The analysis included 2465 women (flibanserin, n = 1227; placebo, n = 1238) with a mean age of 36 years and a mean HSDD duration of 56.5 months. The mean ± standard error (SE) change from baseline to study end in SSEs over 28 days for flibanserin versus placebo was 2.1 ± 0.14 versus 1.2 ± 0.11, respectively ( p < 0.0001). The least-squares mean ± SE changes from baseline to study end in FSFI desire domain score and FSDS-R-13 score were also significantly greater for flibanserin versus placebo (FSFI desire domain: 0.9 ± 0.04 vs. 0.6 ± 0.04, p < 0.0001; FSDS-R-13: -0.9 ± 0.04 vs. -0.6 ± 0.04, p < 0.0001). Patients in the flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics. Adverse events occurring in ≥10% of patients included dizziness and somnolence. Conclusions: This pooled analysis of three pivotal trials demonstrated that flibanserin 100 mg qhs was well tolerated, improved sexual desire, and reduced sexual distress associated with HSDD in premenopausal women, and these improvements were generally consistent across various subgroups based on demographic and baseline characteristics.",2019,"Patients in the flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics.","['premenopausal women with HSDD', 'Premenopausal Hypoactive Sexual Desire Disorder', '2465 women (flibanserin, n \u2009=\u20091227; placebo, n \u2009=\u20091238) with a mean age of 36 years and a mean HSDD duration of 56.5 months', 'premenopausal women']","['Flibanserin, a 5-hydroxytryptamine 5-HT 1A agonist and 5-HT 2A antagonist', 'placebo', 'flibanserin', 'Flibanserin']","['dizziness and somnolence', 'Adverse events', 'FSFI desire domain score and FSDS-R-13 score', 'mean\u2009±\u2009standard error (SE) change', 'SSEs, FSFI-d score, and FSDS-R-13', 'number of satisfying sexual events (SSEs) over 28 days, the Female Sexual Function Index desire domain (FSFI-d) score, and the Female Sexual Distress Scale-Revised Item 13 (FSDS-R-13) score', 'tolerated, improved sexual desire, and reduced sexual distress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020594', 'cui_str': 'Hypoactive Sexual Desire Disorder'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",2465.0,0.391282,"Patients in the flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': '1 Department of Obstetrics and Gynecology, George Washington University School of Medicine, Washington, District of Columbia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thorp', 'Affiliation': '2 Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Millheiser', 'Affiliation': '3 Sprout Pharmaceuticals, Inc., Raleigh, North Carolina.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7516']
1499,30692886,Comparative evaluation of two approaches of infraclavicular brachial plexus block for upper-limb surgeries.,"Background
Infraclavicular approach is a common technique of brachial plexus block. The main difficulty of ultrasound guided technique is in needle visualization due to deep location of the cords. Hebbard et al described a retroclavicular approach wherein the needle was inserted posteriorly to the clavicle.
Materials and Methods
In this prospective randomized controlled study, we have compared the classical technique with the retroclavicular approach in terms of needle visibility, block success rate, number of needle passes, block performance time, procedure-related pain, complications, patient and operator comfort and satisfaction.
Results
The rate of block success was similar in both the groups. The needle tip and shaft visibility was more in the retroclavicular group ( P < 0.05). The number of needle passes was also less in the retroclavicular group. Time for the block procedure was less in retroclavicular group when compared to the classical coracoid group. The patients reported less pain in retroclavicular group ( P < 0.05).
Discussion
Retroclavicular approach is a feasible option of infraclavicular brachial plexus block in Indian Subpopulation in terms of needle visibility and block success rate.",2019,The needle tip and shaft visibility was more in the retroclavicular group ( P < 0.05).,['upper-limb surgeries'],['infraclavicular brachial plexus block'],"['pain', 'rate of block success', 'number of needle passes', 'needle visibility, block success rate, number of needle passes, block performance time, procedure-related pain, complications, patient and operator comfort and satisfaction', 'needle tip and shaft visibility']","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}]",,0.0228656,The needle tip and shaft visibility was more in the retroclavicular group ( P < 0.05).,"[{'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Sinha', 'Affiliation': 'Department of Anaesthesia, AIIMS, Patna, Bihar, India.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesia, AIIMS, Patna, Bihar, India.'}, {'ForeName': 'Amarjeet', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesia, AIIMS, Patna, Bihar, India.'}, {'ForeName': 'Ajeet', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, AIIMS, New Delhi, India.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopedics, AIIMS, Patna, Bihar, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_737_17']
1500,31693128,"Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial.","Importance
In the United States, more than 50% of cervical cancers are diagnosed in underscreened women. Cervical cancer screening guidelines now include primary human papillomavirus (HPV) testing as a recommended strategy. Home-based HPV self-sampling is a viable option for increasing screening compliance and effectiveness; however, US data are needed to inform health care system implementation.
Objective
To evaluate effectiveness of mailed HPV self-sampling kits vs usual care reminders for in-clinic screening to increase detection and treatment of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and uptake of cervical cancer screening.
Design, Setting, and Participants
Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Women aged 30 to 64 years with health plan enrollment for 3 years and 5 months or more, a primary care clinician, no Papanicolaou test within 3 years and 5 months, and no hysterectomy were identified through electronic medical records and enrolled from February 25, 2014, to August 29, 2016, with follow-up through February 26, 2018.
Interventions
The control group received usual care (annual patient reminders and ad hoc outreach from primary care clinics). The intervention group received usual care plus a mailed HPV self-sampling kit.
Main Outcomes and Measures
Two primary outcomes were (1) CIN2+ detection within 6 months of screening and (2) treatment within 6 months of CIN2+ detection. Screening uptake within 6 months of randomization was a secondary outcome.
Results
A total of 19 851 women (mean [SD] age, 50.1 [9.5] years) were included, with 9960 randomized to the intervention group and 9891 randomized to the control group. All women randomized were included in analysis. In the intervention group, 12 participants with CIN2+ were detected compared with 8 in the control group (relative risk, 1.49; 95% CI, 0.61-3.64) and 12 cases were treated vs 7 in the control group (relative risk, 1.70; 95% CI, 0.67-4.32). Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60).
Conclusions and Relevance
Mailing HPV kits to underscreened women increased screening uptake compared with usual care alone, with no significant differences in precancer detection or treatment. Results support the feasibility of mailing HPV kits to women who are overdue for screening as an outreach strategy to increase screening uptake in US health care systems. Efforts to increase kit uptake and follow-up of positive results are warranted to maximize detection and treatment of CIN2+.
Trial Registration
ClinicalTrials.gov identifier: NCT02005510.",2019,"Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60).
","['Women aged 30 to 64 years with health plan enrollment for 3 years and 5 months or more, a primary care clinician, no Papanicolaou test within 3 years and 5 months, and no hysterectomy were identified through electronic medical records and enrolled from February 25, 2014, to August 29, 2016, with follow-up through February 26, 2018', 'A total of 19\u202f851 women (mean [SD] age, 50.1 [9.5] years) were included, with 9960 randomized to the intervention group and 9891 randomized to the control group']","['usual care plus a mailed HPV self-sampling kit', 'mailed HPV self-sampling kits vs usual care reminders', 'Mailed Human Papillomavirus Test Kits vs Usual Care Reminders', 'usual care (annual patient reminders and ad hoc outreach from primary care clinics']","['Screening uptake', 'Cervical Cancer Screening Uptake, Precancer Detection', 'CIN2+ detection within 6 months of screening and (2) treatment within 6 months of CIN2+ detection', 'cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and uptake of cervical cancer screening']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3541459', 'cui_str': 'Papanicolaou Smear'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2 (disorder)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",2618.0,0.115907,"Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60).
","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Winer', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Jasmin A', 'Initials': 'JA', 'LastName': 'Tiro', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Miglioretti', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Beatty', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Kilian', 'Initials': 'K', 'LastName': 'Kimbel', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Thayer', 'Affiliation': 'Kaiser Permanente Washington, Renton.'}, {'ForeName': 'Diana S M', 'Initials': 'DSM', 'LastName': 'Buist', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14729']
1501,30664267,Efficacy of Granulocyte Colony-stimulating Factor in the Management of Steroid-Nonresponsive Severe Alcoholic Hepatitis: A Double-Blind Randomized Controlled Trial.,"Severe alcoholic hepatitis (SAH) is often a progressive disease with high mortality and limited steroid responsiveness. Management options of steroid nonresponsive SAH (day 7 Lille score > 0.45) are limited. We assessed the efficacy and safety of granulocyte colony-stimulating factor (G-CSF) in steroid nonresponders. A randomized, double-blind, single-center trial (NCT01820208) was conducted between March 2013 and June 2016 in patients with histologically proven SAH, nonresponsive to 40 mg/day of prednisolone were randomized to G-CSF (12 doses, 300 μg each in 28 days) or placebo. Responders were continued with prednisolone. Of the 430 patients with SAH, 132 received steroid therapy. Of these, 33 (25%) were nonresponders and were randomized to G-CSF or placebo (14 in each group after exclusions). The baseline characteristics of both groups were comparable. The 28-day mortality was comparable between the groups (21.4%, G-CSF; 28.6%, placebo; P = 0.69). At 90 days, in the G-CSF but not in the placebo group, the Model for End-Stage Liver Disease reduced from 24.6 ± 3.9 to 19.4 ± 3.7 (P = 0.002) and Maddrey's discriminant function from 74.8 ± 22.8 to 57.4 ± 31 (P = 0.26). Infections were less common (28% versus 71%; P < 0.001) with lower 90-day mortality (35.7% versus 71.4%; P = 0.04) in the G-CSF than in the placebo group. On Cox regression analysis, receiving G-CSF (hazard ratio, 0.37; SD, 0.14-0.98; P = 0.04), and high baseline serum creatinine (hazard ratio, 4.12; SD, 1.7-10.3; P = 0.002) predicted day-90 outcomes in steroid nonresponsive SAH. Patients tolerated G-CSF without any major adverse events. Conclusion: Approximately one-quarter of patients with SAH do not respond to corticosteroid therapy. Administration of G-CSF is safe and helps to reduce the disease severity and 90-day mortality in these patients.",2019,Infections were less common (28% versus 71%; P < 0.001) with lower 90-day mortality (35.7% versus 71.4%; P = 0.04) in the G-CSF than in the placebo group.,"['Severe alcoholic hepatitis (SAH', 'March 2013 and June 2016 in patients with histologically proven SAH, nonresponsive to 40 mg/day of', 'Steroid-Nonresponsive Severe Alcoholic Hepatitis', '430 patients with SAH, 132 received', 'steroid nonresponders']","['G-CSF', 'placebo', 'granulocyte colony-stimulating factor (G-CSF', 'G-CSF or placebo', 'steroid therapy', 'Granulocyte Colony-stimulating Factor', 'prednisolone']","['90-day mortality', 'disease severity and 90-day mortality', '28-day mortality', 'efficacy and safety', 'high baseline serum creatinine']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019187', 'cui_str': 'Hepatitis, Alcoholic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}]",430.0,0.465369,Infections were less common (28% versus 71%; P < 0.001) with lower 90-day mortality (35.7% versus 71.4%; P = 0.04) in the G-CSF than in the placebo group.,"[{'ForeName': 'Saggere Muralikrishna', 'Initials': 'SM', 'LastName': 'Shasthry', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Sharma', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Shasthry', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Apurva', 'Initials': 'A', 'LastName': 'Pande', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30516']
1502,31691053,Effect of ozone and diode laser (635 nm) in reducing orthodontic pain in the maxillary arch-a randomized clinical controlled trial.,"The effect of ozone, diode laser irradiation, and presence of teeth crowding/spacing on pain perception in orthodontic patient was tested. Overall, 76 patients [55 women and 21 men; age 35.1(6.4) years] who met the inclusion criteria participated in the study. Immediately after fixed orthodontic appliance placement, the patients were exposed to a pain relief treatment (one single session) using either 635-nm diode laser (SmartM, Lasotronix, Warsaw, Poland) or ozone therapy (OzoneDTA, Apoza, New Taipei City, Taiwan) by placing the handpieces in the area of each teeth apex and interdental papillae, from the maxillary right first molar to the maxillary left first molar. Subjects were divided into three groups: control group (G1, n = 26), ozone (G2, n = 26, exposed to ozone therapy, generator probe type 3, working time per point 5 s, 23 points, application time 1 min and 55 s), and laser group (G3, n = 25, exposed to continuous mode diode laser, 400 mW, handpiece diameter 8 mm, spot area 0.5024 cm 2 , power density per second 1.59 W/cm 2 , dose 2 J per point, time: 5 s per point, 23 points, total energy per session 46 J, application time 1 min and 55 s). The level of teeth crowding was assessed using the Lundstrom indicator. The patients received a questionnaire for pain assessment (the Numeric Rating Scale, NRS-11, grade level 0-10) and recorded at 7 time points (1 h, 6 h, and 1, 2, 3, 4, and 5 days ) after the fixed orthodontic appliance placement. The mean pain values for the diode laser, ozone, and control group were 3.6 (1.31) (95% CI, 2.95-4.25), 5.25 (3.37) (95% CI, 3.52-6.98), and 5.75 (2.40) (95% CI, 4.69-6.81), respectively. We observed lower pain values in the diode laser group compared to the control group (p = 0.0237). The use of ozone in this study did not result in significant pain reduction in comparison to control (p = 0.8040) and laser groups (p = 0.1029). There were no differences in pain perception between patients with crowded teeth and non-crowded teeth in each group (G1, p = 0.66, G2, p = 0.86, G3, p = 0.24). The use of 635-nm diode laser led to decreased pain perception; however, ozone and presence of teeth crowding/spacing did not affect the pain perception in orthodontic patients during the first 5 days after the fixed orthodontic appliance placement.",2020,We observed lower pain values in the diode laser group compared to the control group (p = 0.0237).,['76 patients [55 women and 21 men; age 35.1(6.4) years] who met the inclusion criteria participated in the study'],"['635-nm diode laser (SmartM, Lasotronix, Warsaw, Poland) or ozone therapy (OzoneDTA, Apoza, New Taipei City, Taiwan', 'ozone and diode laser (635 nm', 'ozone (G2, n = 26, exposed to ozone therapy, generator probe type 3, working time per point 5 s, 23 points, application time 1 min and 55 s), and laser group (G3, n = 25, exposed to continuous mode diode laser', 'ozone, diode laser irradiation', '635-nm diode laser', 'diode laser']","['pain values', 'level of teeth crowding', 'mean pain values', 'pain perception', 'orthodontic pain', 'pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040433', 'cui_str': 'Tooth Crowding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",55.0,0.0567412,We observed lower pain values in the diode laser group compared to the control group (p = 0.0237).,"[{'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Matys', 'Affiliation': 'Dental Surgery Department, Medical University, Wrocław, Poland. jacek.matys@wp.pl.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Jaszczak', 'Affiliation': 'Private Dental Practice, Wschowa, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Flieger', 'Affiliation': 'Private Dental Practice, Kościan, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kostrzewska-Kaminiarz', 'Affiliation': 'Private Dental Practice, Wschowa, Poland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Grzech-Leśniak', 'Affiliation': 'Dental Surgery Department, Medical University, Wrocław, Poland.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Dominiak', 'Affiliation': 'Dental Surgery Department, Medical University, Wrocław, Poland.'}]",Lasers in medical science,['10.1007/s10103-019-02896-0']
1503,30692882,Risk of early postoperative acute kidney injury with stroke volume variation-guided tetrastarch versus Ringer's lactate.,"Background
Whether intraoperative use of hydroxyethyl starch (HES) solutions is associated with postoperative acute kidney injury (AKI) continues to be researched. Urinary neutrophil gelatinase-associated lipocalin (NGAL) is validated for early detection of AKI. Previous studies are limited and use empirically predefined volumes of HES solutions with serum creatinine as marker for AKI.
Materials and Methods
Adults scheduled for orthopedic surgery under general anesthesia with >200-300 mL blood loss expected were included; 40 were randomized to receive 6% HES 130/0.4 (tetrastarch) (group HES) or Ringer's lactate (group RL) boluses when stroke volume variation (SVV) >10% in supine or lateral position, or >14% in prone position. Incidence of early postoperative AKI using urinary NGAL (>100 ng/mL) was the primary outcome, and using derangement of serum creatinine was the secondary measure.
Results
In 38 patients, intervention was completed, and incidence of AKI (postoperative urinary NGAL >100 ng/mL) among them was 0% in both groups. Patients with urinary NGAL >50 ng/mL were insignificantly higher for group RL versus group HES (6/19 vs. 4/19) ( P = 0.461), as were those with incidence of AKI as per creatinine values (5/19 vs. 4/19) ( P = 1.000). Group RL had significantly higher requirement of fluid (1211 ± 758 mL vs. 689 ± 394 mL) ( P = 0.013) and lower cardiac index ( P < 0.05) versus group HES.
Conclusion
SVV-guided tetrastarch and Ringer's lactate do not result in postoperative AKI diagnosed by urinary NGAL >100 ng/mL; however, an insignificant trend for better renal functions as well as significantly more efficacious volume expansion and hemodynamic stability were seen with tetrastarch instead.",2019,Group RL had significantly higher requirement of fluid (1211 ± 758 mL vs. 689 ± 394 mL),"['Materials and Methods\n\n\nAdults scheduled for orthopedic surgery under general anesthesia with >200-300 mL blood loss expected were included; 40', 'Patients with urinary NGAL ']","['hydroxyethyl starch (HES) solutions', ""HES 130/0.4 (tetrastarch) (group HES) or Ringer's lactate (group RL"", ""stroke volume variation-guided tetrastarch versus Ringer's lactate""]","['Urinary neutrophil gelatinase-associated lipocalin (NGAL', 'stroke volume variation (SVV', 'efficacious volume expansion and hemodynamic stability', 'incidence of AKI (postoperative urinary NGAL ', 'lower cardiac index', 'renal functions', 'incidence of AKI as per creatinine values']","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1816356', 'cui_str': 'Product containing tetrastarch'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.465491,Group RL had significantly higher requirement of fluid (1211 ± 758 mL vs. 689 ± 394 mL),"[{'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Tyagi', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital, New Delhi, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Verma', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital, New Delhi, India.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Luthra', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital, New Delhi, India.'}, {'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Lahan', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital, New Delhi, India.'}, {'ForeName': 'Shukla', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Microbiology, University College of Medical Sciences and GTB Hospital, New Delhi, India.'}, {'ForeName': 'Gargi', 'Initials': 'G', 'LastName': 'Rai', 'Affiliation': 'Department of Microbiology, University College of Medical Sciences and GTB Hospital, New Delhi, India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Sethi', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_410_18']
1504,30692885,GlideScope ® cobalt video laryngoscope versus direct Miller laryngoscope for lateral position-tracheal intubation in neonates with myelodysplasia: A prospective randomized study.,"Background and Objective
Anesthesiologists encounter difficulties during laryngoscopy and tracheal intubation of neonates with myelodysplasia. Tracheal intubation in lateral position in such cases deemed profitable but not easy because of the compromised laryngeal view. We compared GlideScope video laryngoscope (GVL) versus conventional Miller direct laryngoscope (DL) for tracheal intubation in laterally positioned neonates with myelodysplasia.
Materials and Methods
Sixty neonates scheduled for elective surgical repair of meningeocele or meningeomyelocele under general anesthesia were allocated randomly for endotracheal intubation using GVL or DL. Percentage of glottis opening (POGO) scores, time to best glottis view (TBGV), endotracheal tube passage time (TPT), intubation time (IT), intubation attempts, and overall success rate of intubation were recorded.
Results
TBGV was significantly shorter in GVL group (median = 6.8 s, range = 3.5-28.2 s) in comparison with DL group (median = 8.4 s, range = 4.8-32.7 s) ( P = 0.01); however, TPT and IT were comparable. POGO scores were significantly higher with GVL group than DL group (median = 93.8, range = 45-100 and median = 82.4, range 10-100, respectively) ( P = 0.001). Overall success of intubation was the same; however, three patients in GVL group required a second attempt for intubation in comparison with five patients in DL group. One patient in DL group required a third attempt.
Conclusion
In laterally positioned neonates, GVL is easier than DL with a similar intubation time, comparable time required for tube passage, better views of the glottis, shorter times to obtain the best glottic view, and high success rate as compared with DL. GlideScope seems to be an effective approach for endotracheal intubation of laterally positioned neonates with myelodysplasia.",2019,"In laterally positioned neonates, GVL is easier than DL with a similar intubation time, comparable time required for tube passage, better views of the glottis, shorter times to obtain the best glottic view, and high success rate as compared with DL.","['laterally positioned neonates with myelodysplasia', 'neonates with myelodysplasia', 'Materials and Methods\n\n\nSixty neonates scheduled for elective surgical repair of meningeocele or meningeomyelocele under general anesthesia']","['GVL', 'endotracheal intubation using GVL or DL', 'Tracheal intubation', 'GlideScope ® cobalt video laryngoscope versus direct Miller laryngoscope', 'GlideScope video laryngoscope (GVL) versus conventional Miller direct laryngoscope (DL']","['TBGV', 'Overall success of intubation', 'POGO scores', 'Percentage of glottis opening (POGO) scores, time to best glottis view (TBGV), endotracheal tube passage time (TPT), intubation time (IT), intubation attempts, and overall success rate of intubation']","[{'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0402830', 'cui_str': 'Miller (occupation)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}]",60.0,0.138419,"In laterally positioned neonates, GVL is easier than DL with a similar intubation time, comparable time required for tube passage, better views of the glottis, shorter times to obtain the best glottic view, and high success rate as compared with DL.","[{'ForeName': 'Eman Ramadan', 'Initials': 'ER', 'LastName': 'Salama', 'Affiliation': 'Department of Anesthesia and Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'El Amrousy', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_460_18']
1505,30715083,Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial.,"Importance
Many women dread undergoing mammography, and some may not attend or reattend breast cancer screening because of the discomfort or pain induced by breast compression.
Objective
To evaluate the noninferiority of the self-compression mammography technique for reducing breast thickness compared with standard compression.
Design, Setting, and Participants
This prospective, parallel-group, noninferiority randomized clinical trial was conducted from May 7, 2013, to October 26, 2015, at 6 cancer care centers in France. Participants were women aged 50 to 75 years, without a history of recent breast surgical procedure or treatment, and who could perform self-compression. Analyses were performed on intention-to-treat basis from January 27, 2017, to March 30, 2018.
Interventions
Patients were randomized 1:1 to the self-compression group or the standard compression group.
Main Outcomes and Measures
Primary end point was breast thickness expressed as the mean of 4 views: right and left craniocaudal and right and left mediolateral oblique. The predefined noninferiority margin was a difference of 3 mm, with a 1-sided 95% CI. Secondary end points included compression force, image quality, requirement for additional views, pain, and patient satisfaction and radiographer assessment questionnaires.
Results
Among the 549 women randomized, 548 (97.3%) completed the trial. Of these, 275 (48.8%) (mean [SD] age, 61.35 [6.34] years) were randomized to the self-compression arm and 273 (48.5%) (mean [SD] age, 60.84 [6.41] years) to the standard compression arm. The difference in the mean thickness between the 2 arms was lower than the noninferiority margin, with an upper 1-sided 95% CI less than 3 mm (-0.17; 95% CI,-∞ to 1.89 mm; P < .05). Compression force was higher in the self-compression group compared with the standard compression arm for the 4 mammographic views. Pain was statistically significantly lower in the self-compression group (n = 274) compared with the standard compression group (n = 269) (median [interquartile range (IQR)] score, 2 [1-5] vs 3 [1-5]; P = .009). No difference was reported in the image quality scores of the 2 groups or in the number of additional views performed (median [IQR] extra views, 2 [2-2] vs 2 [2-3] extra views; P = .64), whatever the indication, including insufficient image quality (29 [16.8%] vs 27 [15.0%] insufficient quality views; P = .65). No adverse effects or pain were reported by the participants after the self-compression mammography.
Conclusions and Relevance
Self-compression does not appear to be inferior to standard compression mammography in achieving minimal breast thickness without increasing pain or compromising image quality; this technique may be an effective option for women who want to be involved in their breast examination.
Trial Registration
ClinicalTrials.gov identifier: NCT02866591.",2019,"Pain was statistically significantly lower in the self-compression group (n = 274) compared with the standard compression group (n = 269) (median [interquartile range (IQR)] score, 2","['women who want to be involved in their breast examination', '549 women randomized, 548 (97.3%) completed the trial', 'May 7, 2013, to October 26, 2015, at 6 cancer care centers in France', 'Mammography', 'Participants were women aged 50 to 75 years, without a history of recent breast surgical procedure or treatment, and who could perform self-compression']","['self-compression group or the standard compression group', 'Self-compression Technique vs Standard Compression', 'self-compression mammography technique']","['breast thickness', 'Pain', 'breast thickness expressed as the mean of 4 views: right and left craniocaudal and right and left mediolateral oblique', 'Compression force', 'compression force, image quality, requirement for additional views, pain, and patient satisfaction and radiographer assessment questionnaires', 'image quality scores', 'adverse effects or pain', 'mean thickness', 'insufficient image quality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0199850', 'cui_str': 'Examination of breast (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0402007', 'cui_str': 'Medical radiographer (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}]",549.0,0.155172,"Pain was statistically significantly lower in the self-compression group (n = 274) compared with the standard compression group (n = 269) (median [interquartile range (IQR)] score, 2","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Henrot', 'Affiliation': 'Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Boisserie-Lacroix', 'Affiliation': 'Department of Radiology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Boute', 'Affiliation': 'Department of Radiology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Troufléau', 'Affiliation': 'Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Boyer', 'Affiliation': 'Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Lesanne', 'Affiliation': 'Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Gillon', 'Affiliation': 'Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Desandes', 'Affiliation': 'Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Netter', 'Affiliation': 'Centre de Radiologie, Nancy, France.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saadate', 'Affiliation': 'Centre de Radiologie, Nancy, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tardivon', 'Affiliation': 'Department of Radiology, Institut Curie, Paris, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Grentzinger', 'Affiliation': ""Centre d'Imagerie Majorelle, Nancy, France.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Salleron', 'Affiliation': 'Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Oldrini', 'Affiliation': 'Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France.'}]",JAMA internal medicine,['10.1001/jamainternmed.2018.7169']
1506,30658935,"PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study.","BACKGROUND
Increased-dose bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP escalated ) improves progression-free survival in patients with advanced Hodgkin lymphoma compared with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD), but is associated with increased risks of haematological toxicity, secondary myelodysplasia or leukaemia, and infertility. We investigated whether PET monitoring during treatment could allow dose de-escalation by switching regimen (BEACOPP escalated to ABVD) in early responders without loss of disease control compared with standard treatment without PET monitoring.
METHODS
AHL2011 is a randomised, non-inferiority, phase 3 study done in 90 centres across Belgium and France. Eligible patients were aged 16-60 years and had newly diagnosed Hodgkin lymphoma, excluding nodular lymphocyte predominant subtype, an Eastern Cooperative Oncology Group performance status score less than 3, a life expectancy of at least 3 months, an Ann Arbor disease stage III, IV, or IIB with mediastinum-to-thorax ratio of 0·33 or greater than or extranodal localisation, and had received no previous treatment for Hodgkin lymphoma. Randomisation was unmasked and done centrally by the permuted block method. Patients were randomly assigned to standard treatment (BEACOPP escalated given every 21 days for six cycles) or PET-driven treatment. All patients received two cycles of upfront BEACOPP escalated , after which PET assessment was done (PET2). In the standard treatment group, PET2 patients completed two additional cycles of BEACOPP escalated induction therapy irrespective of PET2 findings. In the PET-driven treatment group, patients with positive PET2 scans received the further two cycles of BEACOPP escalated and those with a negative PET2 scan switched to two cycles of ABVD for the remaining induction therapy. In both treatment groups, PET at the end of induction therapy was used to decide whether to continue with consolidation therapy in those with negative scans or start salvage therapy in patients with positive scans (either two cycles of ABVD in PET2-negative patients in the PET-driven arm or two cycles of BEACOPP escalated ). BEACOPP escalated consisted of bleomycin 10 mg/m 2 and vincristine 1·4 mg/m 2 intravenously on day 8, etoposide 200 mg/m 2 intravenously on days 1-3, doxorubicin 35 mg/m 2 and cyclophosphamide 1250 mg/m 2 intravenously on day 1, 100 mg/m 2 oral procarbazine on days 1-7, and 40 mg/m 2 oral prednisone on days 1-14. ABVD was given every 28 days (doxorubicin 25 mg/m 2 , bleomycin 10 mg/m 2 , vinblastine 6 mg/m 2 , and dacarbazine 375 mg/m 2 intravenously on days 1 and 15). The primary endpoint was investigator-assessed progression-free survival. Non-inferiority analyses were done by intention to treat and per protocol. The study had a non-inferiority margin of 10%, to show non-inferiority of PET-guided treatment versus standard care with 80% power and an alpha of 2·5% (one-sided). This study is registered with ClinicalTrials.gov, number NCT01358747.
FINDINGS
From May 19, 2011, to April 29, 2014, 823 patients were enrolled-413 in the standard care group and 410 in the PET-driven group. 346 (84%) of 410 patients in the PET-driven treatment group were assigned to receive ABVD and 51 (12%) to continue receiving BEACOPP escalated after PET2. With a median follow-up of 50·4 months (IQR 42·9-59·3), 5-year progression-free survival by intention to treat was 86·2%, 95% CI 81·6-89·8 in the standard treatment group versus 85·7%, 81·4-89·1 in the PET-driven treatment group (hazard ratio [HR] 1·084, 95% CI 0·737-1·596; p=0·65) and per protocol the values were 86·7%, 95% CI 81·9-90·3 and 85·4%, 80·7-89·0, respectively (HR 1·144, 0·758-1·726; p=0·74). The most common grade 3-4 adverse events were leucopenia (381 [92%] in the standard treatment group and 387 [95%] in the PET-driven treatment group), neutropenia (359 [87%] and 366 [90%]), anaemia (286 [69%] vs 114 [28%]), thrombocytopenia (271 [66%] and 163 [40%]), febrile neutropenia (145 [35%] and 93 [23%]), infections (88 [22%] and 47 [11%]), and gastrointestinal disorders (49 [11%] and 48 [11%]). Serious adverse events related to treatment were reported in 192 (47%) patients in the standard treatment group and 114 (28%) in the PET-driven treatment group, including infections (84 [20%] of 412 vs 50 [12%] of 407) and febrile neutropenia (21 [5%] vs 23 [6%]). Six (1%) patients in the standard care group died from treatment-related causes (two from septic shock, two from pneumopathy, one from heart failure, and one from acute myeloblastic leukaemia), as did two (<1%) in the PET-driven treatment group (one from septic shock and one from acute myeloblastic leukaemia).
INTERPRETATION
PET after two cycles of induction BEACOPP escalated chemotherapy safely guided treatment in patients with advanced Hodgkin lymphoma and allowed the use of ABVD in early responders without impairing disease control and reduced toxicities. PET staging allowed accurate monitoring of treatment in this trial and could be considered as a strategy for the routine management of patients with advanced Hodgkin lymphoma.
FUNDING
Programme Hospitalier de Recherche Clinique.",2019,"The most common grade 3-4 adverse events were leucopenia (381 [92%] in the standard treatment group and 387 [95%] in the PET-driven treatment group), neutropenia (359 [87%] and 366 [90%]), anaemia (286 [69%] vs 114 [28%]), thrombocytopenia (271 [66%] and 163 [40%]), febrile neutropenia (145 [35%] and 93 [23%]), infections (88 [22%] and 47 [11%]), and gastrointestinal disorders (49 [11%] and 48 [11%]).","['Eligible patients were aged 16-60 years and had newly diagnosed Hodgkin lymphoma, excluding nodular lymphocyte predominant subtype, an Eastern Cooperative Oncology Group performance status score less than 3, a life expectancy of at least 3 months, an Ann Arbor disease stage III, IV, or IIB with mediastinum-to-thorax ratio of 0·33 or greater than or extranodal localisation, and had received no previous treatment for Hodgkin lymphoma', 'newly diagnosed advanced Hodgkin lymphoma (AHL2011', 'patients with advanced Hodgkin lymphoma', 'From May 19, 2011, to April 29, 2014, 823 patients were enrolled-413 in the standard care group and 410 in the PET-driven group', '90 centres across Belgium and France']","['bleomycin', 'BEACOPP', 'upfront BEACOPP', 'vincristine 1·4', 'etoposide', 'cyclophosphamide 1250', 'doxorubicin 25 mg/m 2 , bleomycin 10 mg/m 2 , vinblastine 6 mg/m 2 , and dacarbazine', 'standard treatment (BEACOPP escalated given every 21 days for six cycles) or PET-driven treatment', 'bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP escalated ', 'BEACOPP escalated after PET2', 'doxorubicin 35', 'PET-adapted treatment', 'doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD', 'ABVD', 'procarbazine']","['anaemia', 'febrile neutropenia', 'progression-free survival', 'neutropenia', 'toxicities', '5-year progression-free survival', 'leucopenia', 'investigator-assessed progression-free survival', 'infections', 'Serious adverse events', 'thrombocytopenia', 'gastrointestinal disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205297', 'cui_str': 'Nodular (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}]",823.0,0.218624,"The most common grade 3-4 adverse events were leucopenia (381 [92%] in the standard treatment group and 387 [95%] in the PET-driven treatment group), neutropenia (359 [87%] and 366 [90%]), anaemia (286 [69%] vs 114 [28%]), thrombocytopenia (271 [66%] and 163 [40%]), febrile neutropenia (145 [35%] and 93 [23%]), infections (88 [22%] and 47 [11%]), and gastrointestinal disorders (49 [11%] and 48 [11%]).","[{'ForeName': 'René-Olivier', 'Initials': 'RO', 'LastName': 'Casasnovas', 'Affiliation': 'Department of Haematology, University Hospital F Mitterrand and Inserm UMR 1231, Dijon, France. Electronic address: olivier.casasnovas@chu-dijon.fr.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bouabdallah', 'Affiliation': 'Department of Haematology, Institut P Calmette, Marseille, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': 'Department of Haematology, APHP, Hôpital Saint Louis, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Lazarovici', 'Affiliation': 'Department of Haematology, Université Paris-Saclay, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ghesquieres', 'Affiliation': 'Department of Haematology, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud and Université Claude Bernard Lyon-1, Pierre Bénite, France.'}, {'ForeName': 'Aspasia', 'Initials': 'A', 'LastName': 'Stamatoullas', 'Affiliation': 'Department of Haematology, Centre H Becquerel, Rouen, France.'}, {'ForeName': 'Jehan', 'Initials': 'J', 'LastName': 'Dupuis', 'Affiliation': 'Department of Haematology, Hôpital H Mondor, Creteil, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Gac', 'Affiliation': ""Department of Haematology, Institut d'hématologie de Basse Normandie, Caen, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gastinne', 'Affiliation': 'Department of Haematology, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Joly', 'Affiliation': 'Department of Haematology, Hospital Sud Francilien, Corbeille-Essonnes, France.'}, {'ForeName': 'Krimo', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': 'Department of Haematology, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'Department of Haematology, Centre L Bérard, Lyon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Department of Haematology, University Hospital of Nancy, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'EA 7365 Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA), Department of Haematology, CHU Lille, Université de Lille, Lille, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Delarue', 'Affiliation': 'Department of Haematology, Hôpital Necker, Paris, France.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Farhat', 'Affiliation': 'Department of Haematology, Hôpital Mignot, Versailles, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Quittet', 'Affiliation': 'Department of Haematology, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Berriolo-Riedinger', 'Affiliation': 'Department of Nuclear Medicine, Centre G F Leclerc, Dijon, France.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tempescul', 'Affiliation': 'Department of Haematology, University Hospital of Brest, Brest, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Edeline', 'Affiliation': 'Department of Nuclear Medicine, Hôpital R Huguenin, Institut Curie, St-Cloud, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Maisonneuve', 'Affiliation': 'Department of Haematology, Centre Hospitalier Départemental de Vendée, Hôpital de La Roche sur Yon, La Roche sur Yon, France.'}, {'ForeName': 'Luc-Matthieu', 'Initials': 'LM', 'LastName': 'Fornecker', 'Affiliation': 'Department of Haematology, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lamy', 'Affiliation': 'Department of Haematology, University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Delmer', 'Affiliation': 'Department of Haematology, University Hospital of Reims, Reims, France.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Dartigues', 'Affiliation': 'Department of Pathology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Department of Pathology, University Hospital F Mitterrand and Inserm UMR 1231, Dijon, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'André', 'Affiliation': 'Department of Haematology, CHU UCL Namur, Université Catholique de Louvain, Yvoir, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mounier', 'Affiliation': 'Department of Haematology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Traverse-Glehen', 'Affiliation': 'Department of Pathology, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud and Université Claude Bernard Lyon-1, Pierre Bénite, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Meignan', 'Affiliation': 'LYSA Imaging, Hôpital H Mondor, Creteil, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30784-8']
1507,28274698,Effects of Short-Term Oxycodone Maintenance on Experimental Pain Responses in Physically Dependent Opioid Abusers.,"A common clinical problem with opioid analgesics is the loss of analgesic efficacy after repeated dosing; when this occurs, it is not clear what principles should guide providing effective analgesia among opioid-dependent individuals. This within-subject inpatient study aimed to determine if physically dependent opioid abusers (n = 11) experience changes in oxycodone-induced analgesia during 2 oxycodone maintenance (30 mg orally 4 times per day) phases: initial stabilization (days 1-3) and after 6 weeks of chronic dosing. Six sessions (3 each phase), measured threshold, tolerance, and pain ratings for a Pressure Pain Test and Cold Pressor Test after a single double-blind dose of oxycodone 30 mg (initial stabilization) and 0, 30, and 60 mg (chronic dosing) given in place of a scheduled maintenance dose. Physiologic and opioid agonist effects were assessed during chronic dosing sessions. There was no analgesic response to oxycodone 30 mg. Oxycodone (60 mg) produced a 25% increase in peak Cold Pressor Test threshold compared with placebo, and significantly increased expired breath CO2, miosis, and ratings of abuse liability measures. These data suggest that more than twice the acute oxycodone maintenance dose is needed to produce robust acute analgesia, although adverse effects (eg, respiratory depression and abuse signals) may occur with lower doses.
PERSPECTIVE
To understand sensitivity to opioid analgesia in opioid-dependent individuals, this article describes experimental pain, subjective and physiological responses during stabilization and after 6 weeks of oxycodone maintenance. Oxycodone produced euphoric effects and miosis with limited evidence of analgesia.",2017,"Oxycodone (60 mg) produced a 25% increase in peak Cold Pressor Test threshold compared with placebo, and significantly increased expired breath CO2, miosis, and ratings of abuse liability measures.","['Physically Dependent Opioid Abusers', 'physically dependent opioid abusers (n\xa0=\xa011) experience changes in oxycodone-induced analgesia during 2 oxycodone maintenance ']","['oxycodone', 'placebo', 'Oxycodone', 'Short-Term Oxycodone Maintenance', 'oxycodone 30\xa0mg (initial stabilization']","['analgesic efficacy', 'analgesic response', 'Physiologic and opioid agonist effects', 'expired breath CO2, miosis, and ratings of abuse liability measures', 'peak Cold Pressor Test', 'threshold, tolerance, and pain ratings for a Pressure Pain Test and Cold Pressor Test', 'Experimental Pain Responses']","[{'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1127511', 'cui_str': 'Oxycodone 30 MG'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0728710', 'cui_str': 'Pupil constriction (observable entity)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0704812,"Oxycodone (60 mg) produced a 25% increase in peak Cold Pressor Test threshold compared with placebo, and significantly increased expired breath CO2, miosis, and ratings of abuse liability measures.","[{'ForeName': 'Marion A', 'Initials': 'MA', 'LastName': 'Coe', 'Affiliation': 'Department of Pharmacology, College of Medicine, University of Kentucky, Lexington, Kentucky; Center on Drug and Alcohol Research, College of Medicine, University of Kentucky, Lexington, Kentucky. Electronic address: Marion.coe@uky.edu.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Nuzzo', 'Affiliation': 'Center on Drug and Alcohol Research, College of Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Lofwall', 'Affiliation': 'Center on Drug and Alcohol Research, College of Medicine, University of Kentucky, Lexington, Kentucky; Department of Behavioral Science, College of Medicine, University of Kentucky, Lexington, Kentucky; Department of Psychiatry, College of Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'Department of Pharmacology, College of Medicine, University of Kentucky, Lexington, Kentucky; Center on Drug and Alcohol Research, College of Medicine, University of Kentucky, Lexington, Kentucky; Department of Behavioral Science, College of Medicine, University of Kentucky, Lexington, Kentucky; Department of Psychiatry, College of Medicine, University of Kentucky, Lexington, Kentucky; Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentucky, Lexington, Kentucky.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2017.02.433']
1508,31513481,Randomized Phase II Trial of Bevacizumab or Temsirolimus in Combination With Chemotherapy for First Relapse Rhabdomyosarcoma: A Report From the Children's Oncology Group.,"PURPOSE
The primary aim of this clinical trial was to prioritize bevacizumab or temsirolimus for additional investigation in rhabdomyosarcoma (RMS) when administered in combination with cytotoxic chemotherapy to patients with RMS in first relapse with unfavorable prognosis.
PATIENTS AND METHODS
Patients were randomly assigned to receive bevacizumab on day 1 or temsirolimus on days 1, 8, and 15 of each 21-day treatment cycle, together with vinorelbine on days 1 and 8, and cyclophosphamide on day 1 for a maximum of 12 cycles. Local tumor control with surgery and/or radiation therapy was permitted after 6 weeks of treatment. The primary end point was event-free survival (EFS). Radiographic response was assessed at 6 weeks. The study had a phase II selection that was design to detect a 15% difference between the two regimens (α = .2; 1-β = 0.8; two sided test).
RESULTS
Eighty-seven of 100 planned patients were enrolled when the trial was closed after the second interim analysis after 46 events occurred in 68 patients with sufficient follow-up. The O'Brien Fleming boundary at this analysis corresponded to a two-sided P value of .058 with an observed two-sided P value of .003 favoring temsirolimus. The 6-month EFS for the bevacizumab arm was 54.6% (95% CI, 39.8% to 69.3%) and 69.1% (95% CI, 55.1% to 83%) for the temsirolimus arm. Objective response rates were 28% (95% CI, 13.7% to 41.3%) and 47% (95% CI, 31.5% to 63.2%) for the bevacizumab and temsirolimus arms, respectively ( P = .12) and, 28% of patients on bevacizumab and 11% on temsirolimus had progressive disease at 6 weeks.
CONCLUSION
Patients who received temsirolimus had a superior EFS compared with bevacizumab. Temsirolimus has been selected for additional investigation in newly diagnosed patients with intermediate-risk RMS.",2019,"Objective response rates were 28% (95% CI, 13.7% to 41.3%) and 47% (95% CI, 31.5% to 63.2%) for the bevacizumab and temsirolimus arms, respectively ( P = .12) and, 28% of patients on bevacizumab and 11% on temsirolimus had progressive disease at 6 weeks.
","['Patients', 'patients with RMS in first relapse with unfavorable prognosis', 'newly diagnosed patients with intermediate-risk RMS', 'First Relapse Rhabdomyosarcoma', 'Eighty-seven of 100 planned patients', 'rhabdomyosarcoma (RMS']","['cyclophosphamide', 'cytotoxic chemotherapy', 'prioritize bevacizumab', 'vinorelbine', 'Bevacizumab or Temsirolimus', 'bevacizumab', 'Local tumor control with surgery and/or radiation therapy']","['Objective response rates', 'Radiographic response', 'event-free survival (EFS', 'progressive disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.121834,"Objective response rates were 28% (95% CI, 13.7% to 41.3%) and 47% (95% CI, 31.5% to 63.2%) for the bevacizumab and temsirolimus arms, respectively ( P = .12) and, 28% of patients on bevacizumab and 11% on temsirolimus had progressive disease at 6 weeks.
","[{'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Children's Hospital Los Angeles and University of Southern California Keck School of Medicine, Los Angeles, CA.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Hingorani', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, AZ.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Merck Research Laboratories: Oncology, North Wales, PA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Lyden', 'Affiliation': 'University of Nebraska College of Medicine, Omaha, NE.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rodeberg', 'Affiliation': 'East Carolina University, Greenville, NC.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Indelicato', 'Affiliation': 'University of Florida, Jacksonville, FL.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': 'University of Iowa Carver College of Medicine, Iowa City, IA.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Dasgupta', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Spunt', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Meyer', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': 'University of Washington, Seattle, WA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00576']
1509,32407827,A simulation approach to measure critical safety behaviors when evaluating training methods for respirator education in healthcare workers.,"BACKGROUND
The N95 respirator is the most common safety tool used in hospitals to protect health care workers (HCW) from inhaling airborne particles. Focusing on HCW behavior related to respirator use is an effective route to improve HCW safety and respiratory health.
METHODS
Participants were asked to perform the donning and doffing of an N95 respirator to camera. Then they were randomized to a video alone or a reflective practice intervention. After the intervention they repeated the donning and doffing to camera. A critical safety behavior scoring tool (CSBST) was developed to compare the performance of the participants over time at pretest, post-test and 1 month later for follow-up.
RESULTS
The reflective practice intervention group was found to have significantly higher scores on the CSBST at post-test and follow-up than the video alone group. In the reflective practice intervention group, the participants perceived they were better at performing the N95 donning and doffing than the experts scored them.
CONCLUSIONS
The CSBST is a tool to measure the performance of HCWs on a specific targeted safety behaviors. The addition of a reflective practice intervention may result in a measurable and sustained improvement in the safety behaviors demonstrated when using the N95 respirator.",2020,The reflective practice intervention group was found to have significantly higher scores on the CSBST at post-test and follow-up than the video alone group.,"['Participants were asked to perform the donning and doffing of an N95 respirator to camera', 'hospitals to protect healthcare workers (HCW) from inhaling airborne particles', 'healthcare workers']","['video alone or a reflective practice intervention', 'CSBST']","['safety behaviors', 'HCW safety and respiratory health']","[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.036832,The reflective practice intervention group was found to have significantly higher scores on the CSBST at post-test and follow-up than the video alone group.,"[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Beam', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE; Nebraska Biocontainment Unit, Omaha, NE. Electronic address: ebeam@unmc.edu.'}, {'ForeName': 'Jocelyn J', 'Initials': 'JJ', 'LastName': 'Herstein', 'Affiliation': 'Nebraska Biocontainment Unit, Omaha, NE; Department of Environmental, Agricultural, and Occupational Health, University of Nebraska Medical Center, College of Public Health, Omaha, NE.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kupzyk', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Shawn G', 'Initials': 'SG', 'LastName': 'Gibbs', 'Affiliation': 'Texas A & M School of Public Health, College Station, TX.'}]",American journal of infection control,['10.1016/j.ajic.2020.05.005']
1510,30622310,A body shape index (ABSI) reflects body composition changes in response to testosterone treatment in obese men.,"BACKGROUND
Interventions such as testosterone treatment may change body composition and metabolic outcomes without substantial changes in weight and BMI.
OBJECTIVES
Using testosterone treatment as a paradigm, we hypothesized that a body shape index (ABSI) reflects body composition changes more accurately than traditional markers, such as weight, BMI and waist circumference.
INTERVENTION
Secondary analysis of a 56-week RCT in 100 dieting obese men with low-normal testosterone receiving testosterone treatment or placebo, and subsequent off-treatment follow-up.
RESULTS
At the end of the trial period, ABSI-unlike weight, BMI or waist circumference-had significantly decreased in the treatment group, compared with placebo (mean adjusted difference -0.18 [95% CI: -0.32, -0.05] × 10 -2 m 11/6 kg -2/3 , overall P<0.001). Changes in ABSI during the active trial phase correlated with changes in fat mass (tau = 0.18, P = 0.02), and not with lean mass (tau = -0.11, P = 0.14), BMI (tau = 0.10, P = 0.17), or visceral fat (tau = 0.07, P = 0.37). ABSI baseline values were positively correlated with waist circumference (tau = 0.21, P = 0.002) and visceral fat (tau = 0.18, P = 0.009), correlated inversely with lean mass (tau = -0.21, P = 0.002), and were uncorrelated with BMI (tau = -0.10, P = 0.15) and fat mass (tau = 0.01, P = 0.83). Two years after cessation of treatment, ABSI again reflected body composition as the between-group differences in all parameters did not persist.
CONCLUSIONS
A readily obtainable anthropomorphic measure, ABSI reflects the differential loss of fat mass mediated by testosterone in dieting obese men more closely than BMI or waist circumference. It may serve as a clinically useful marker to monitor body composition changes, particularly in response to interventions.",2019,"ABSI baseline values were positively correlated with waist circumference (tau = 0.21, P = 0.002) and visceral fat (","['obese men', '100 dieting obese men with low-normal testosterone receiving testosterone treatment or placebo, and subsequent off-treatment follow-up']","['testosterone', 'placebo']","['visceral fat', 'waist circumference', 'BMI', 'lean mass', 'ABSI-unlike weight, BMI or waist circumference', 'fat mass', 'ABSI baseline values', 'ABSI again reflected body composition', 'visceral fat ', 'fat mass ']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",100.0,0.105736,"ABSI baseline values were positively correlated with waist circumference (tau = 0.21, P = 0.002) and visceral fat (","[{'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Hoermann', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, VIC, Australia. rudolf.hoermann@gmail.com.'}, {'ForeName': 'Mark Ng Tang', 'Initials': 'MNT', 'LastName': 'Fui', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, VIC, Australia.'}, {'ForeName': 'Jesse C', 'Initials': 'JC', 'LastName': 'Krakauer', 'Affiliation': 'Metro Detroit Diabetes and Endocrinology, Southfield, MI, USA.'}, {'ForeName': 'Nir Y', 'Initials': 'NY', 'LastName': 'Krakauer', 'Affiliation': 'Department of Civil Engineering, City College of New York, New York, NY, USA.'}, {'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, VIC, Australia.'}]",International journal of obesity (2005),['10.1038/s41366-018-0311-y']
1511,30658933,"Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial.","BACKGROUND
Human papillomavirus (HPV) testing on self-collected samples is a potential alternative to HPV testing on clinician-collected samples, but non-inferiority of its clinical accuracy remains to be assessed in the regular screening population. The IMPROVE study was done to evaluate the clinical accuracy of primary HPV testing on self-collected samples within an organised screening setting.
METHODS
In this randomised, non-inferiority trial, women aged 29-61 years were invited to participate in the study as part of their regular screening invitation in the Netherlands. Women who provided informed consent were randomly allocated (1:1, with a block size of ten stratified by age) to one of two groups: a self-sampling group, in which women were requested to collect their own cervicovaginal sample using an Evalyn Brush (Rovers Medical Devices BV, Oss, Netherlands); or a clinician-based sampling group, in which samples were collected by a general practitioner with a Cervex-Brush (Rovers Medical Devices BV). All samples were tested for HPV using the clinically validated GP5+/6+ PCR enzyme immunoassay (Labo Biomedical Products BV, Rijswijk, Netherlands). HPV-positive women in both groups were retested with the other collection method and triaged by cytology and repeat cytology in accordance with current Dutch screening guidelines. Primary endpoints were detection of cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+). Non-inferiority of HPV testing on self-collected versus clinician-collected samples was evaluated against a margin of 90% for the relative sensitivity and 98% for the relative specificity. This study is registered at the Dutch Trial register (NTR5078) and has been completed.
FINDINGS
Of the 187 473 women invited to participate, 8212 were randomly allocated to the self-sampling group and 8198 to the clinician-based sampling group. After exclusion of women who met the exclusion criteria or who did not return their sample, 7643 women were included in the self-sampling group and 6282 in the clinician-based sampling group. 569 (7·4%) self-collected samples and 451 (7·2%) clinician-collected samples tested positive for HPV (relative risk 1·04 [95% CI 0·92-1·17]). Median follow-up duration for HPV-positive women was 20 months (IQR 17-22). The CIN2+ sensitivity and specificity of HPV testing did not differ between self-sampling and clinician-based sampling (relative sensitivity 0·96 [0·90-1·03]; relative specificity 1·00 [0·99-1·01]). For the CIN3+ endpoint, relative sensitivity was 0·99 (0·91-1·08) and relative specificity was 1·00 (0·99-1·01).
INTERPRETATION
HPV testing done with a clinically validated PCR-based assay had similar accuracy on self-collected and clinician-collected samples in terms of the detection of CIN2+ or CIN3+ lesions. These findings suggest that HPV self-sampling could be used as a primary screening method in routine screening.
FUNDING
Ministry of Health, Welfare, and Sport (Netherlands), and the European Commission.",2019,The CIN2+ sensitivity and specificity of HPV testing did not differ between self-sampling and clinician-based sampling (relative sensitivity 0·96,"['cervical intraepithelial neoplasia of grade 2 or worse', 'Of the 187\u2008473 women invited to participate', 'women who met the exclusion criteria or who did not return their sample, 7643 women were included in the self-sampling group and 6282 in the clinician-based sampling group', 'Women who provided informed consent', 'women aged 29-61 years were invited to participate in the study as part of their regular screening invitation in the Netherlands']","['self-sampling group and 8198 to the clinician-based sampling group', 'self-sampling group, in which women were requested to collect their own cervicovaginal sample using an Evalyn Brush (Rovers Medical Devices BV, Oss, Netherlands); or a clinician-based sampling group, in which samples were collected by a general practitioner with a Cervex-Brush (Rovers Medical Devices BV', 'human papillomavirus testing on self-collected versus clinician-collected samples']","['detection of cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN2+) and grade 3 or worse (CIN3', 'CIN2+ sensitivity and specificity of HPV testing']","[{'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0025080', 'cui_str': 'Medical Devices'}, {'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",7643.0,0.17207,The CIN2+ sensitivity and specificity of HPV testing did not differ between self-sampling and clinician-based sampling (relative sensitivity 0·96,"[{'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'Polman', 'Affiliation': 'Cancer Centre Amsterdam, Department of Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Renée M F', 'Initials': 'RMF', 'LastName': 'Ebisch', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Daniëlle A M', 'Initials': 'DAM', 'LastName': 'Heideman', 'Affiliation': 'Cancer Centre Amsterdam, Department of Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Willem J G', 'Initials': 'WJG', 'LastName': 'Melchers', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Ruud L M', 'Initials': 'RLM', 'LastName': 'Bekkers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Anco C', 'Initials': 'AC', 'LastName': 'Molijn', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, Netherlands.'}, {'ForeName': 'Chris J L M', 'Initials': 'CJLM', 'LastName': 'Meijer', 'Affiliation': 'Cancer Centre Amsterdam, Department of Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Wim G V', 'Initials': 'WGV', 'LastName': 'Quint', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, Netherlands.'}, {'ForeName': 'Peter J F', 'Initials': 'PJF', 'LastName': 'Snijders', 'Affiliation': 'Cancer Centre Amsterdam, Department of Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Leon F A G', 'Initials': 'LFAG', 'LastName': 'Massuger', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Folkert J', 'Initials': 'FJ', 'LastName': 'van Kemenade', 'Affiliation': 'Department of Pathology, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Berkhof', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health, Amsterdam, Netherlands. Electronic address: h.berkhof@vumc.nl.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30763-0']
1512,29121545,Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial.,"Higher-order cognitive training has shown to enhance performance in older adults, but the neural mechanisms underlying performance enhancement have yet to be fully disambiguated. This randomized trial examined changes in processing speed and processing speed-related neural activity in older participants (57-71 years of age) who underwent cognitive training (CT, N = 12) compared with wait-listed (WLC, N = 15) or exercise-training active (AC, N = 14) controls. The cognitive training taught cognitive control functions of strategic attention, integrative reasoning, and innovation over 12 weeks. All 3 groups worked through a functional magnetic resonance imaging processing speed task during 3 sessions (baseline, mid-training, and post-training). Although all groups showed faster reaction times (RTs) across sessions, the CT group showed a significant increase, and the WLC and AC groups showed significant decreases across sessions in the association between RT and BOLD signal change within the left prefrontal cortex (PFC). Thus, cognitive training led to a change in processing speed-related neural activity where faster processing speed was associated with reduced PFC activation, fitting previously identified neural efficiency profiles.",2018,"Although all groups showed faster reaction times (RTs) across sessions, the CT group showed a significant increase, and the WLC and AC groups showed significant decreases across sessions in the association between RT and BOLD signal change within the left prefrontal cortex (PFC).","['older participants (57-71\xa0years of age) who underwent', 'older adults']","['cognitive training (CT, N\xa0= 12) compared with wait-listed (WLC, N\xa0= 15) or exercise-training active (AC, N\xa0= 14) controls', 'cognitive training', 'processing speed and processing speed-related neural activity']","['faster reaction times (RTs', 'processing speed-related neural activity', 'RT and BOLD signal change within the left prefrontal cortex (PFC']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",,0.0177515,"Although all groups showed faster reaction times (RTs) across sessions, the CT group showed a significant increase, and the WLC and AC groups showed significant decreases across sessions in the association between RT and BOLD signal change within the left prefrontal cortex (PFC).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Motes', 'Affiliation': 'Center for BrainHealth, The University of Texas at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Uma S', 'Initials': 'US', 'LastName': 'Yezhuvath', 'Affiliation': 'Advance MRI, LLC, Frisco, TX, USA.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Aslan', 'Affiliation': 'Center for BrainHealth, The University of Texas at Dallas, Dallas, TX, USA; Advance MRI, LLC, Frisco, TX, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Spence', 'Affiliation': 'Center for BrainHealth, The University of Texas at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Rypma', 'Affiliation': 'Center for BrainHealth, The University of Texas at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Chapman', 'Affiliation': 'Center for BrainHealth, The University of Texas at Dallas, Dallas, TX, USA. Electronic address: schapman@utdallas.edu.'}]",Neurobiology of aging,['10.1016/j.neurobiolaging.2017.10.003']
1513,32408117,"Effects of saffron supplementation on glycemia and inflammation in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial study.","BACKGROUND
New evidence indicates that overproduction of pro-inflammatory cytokines is responsible for the development of diabetes difficulties. Some herbals such as saffron, may control inflammation and improve the hyperglycemic states in diabetic patients. Therefore, this investigation aimed to assess the effects of saffron supplementation on fasting glucose and inflammatory markers levels in patients with type2 diabetes mellitus (T2DM).
METHODS
In this randomized double-blind, placebo-controlled clinical trial, 60 T2DM patients were randomly assigned into two groups as saffron and placebo (n = 30) receiving 100 mg/day saffron powder or starch capsules (1 capsule) for a duration of 8 weeks. Fasting blood sample was collected at baseline and at the end of the intervention. Fasting blood glucose (FBG) was immediately analyzed by the auto-analyzer. The serum level of Interleukin -6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10) were measured using ELISA assay by laboratory kits. Also, Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level.
RESULTS
Saffron supplementation significantly decreased the FBG levels within 8 weeks compared to placebo (130.93 ± 21.21 vs 135.13 ± 23.03 mg/dl, P = 0.012). Moreover, the serum level of TNF-α notably reduced in the saffron group compared to the placebo group (114.40 ± 24.28 vs 140.90 ± 25.49 pg/ml, P < 0.001). Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
CONCLUSION
In our study, it was indicated that saffron modulates glucose levels as well as inflammation status in T2DM patients through decreasing the expressions levels of some inflammatory mediators. Also, further investigations are necessary to confirm the positive effects of saffron as a complementary therapy for T2DM patients.",2020,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","['60 T2DM patients', 'patients with type 2 diabetes mellitus', 'patients with type2 diabetes mellitus (T2DM', 'diabetic patients', 'T2DM patients']","['saffron supplementation', 'saffron and placebo (n\xa0=\xa030) receiving 100\xa0mg/day saffron powder or starch capsules', 'placebo']","['IL-6 mRNA levels', 'hyperglycemic states', 'glycemia and inflammation', 'Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level', 'FBG levels', 'expressions of TNF-α', 'fasting glucose and inflammatory markers levels', 'Fasting blood glucose (FBG', 'serum level of Interleukin\xa0-6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10', 'serum level of TNF-α', 'Fasting blood sample']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",60.0,0.491142,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aynaz', 'Initials': 'A', 'LastName': 'Tajaddini', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Pharmacology School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Meisam', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Student Research Committee, Department of Cellular and Molecular Nutrition, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Students Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Houshyar', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: roshanravann@tbzmed.ac.ir.'}, {'ForeName': 'Naimeh Mesri', 'Initials': 'NM', 'LastName': 'Alamdari', 'Affiliation': 'Student Research Committee, Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: mesrialamdari.n@tak.iums.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.031']
1514,31688513,"""Get a Grip on Hypertension"": EXPLORING THE USE OF ISOMETRIC HANDGRIP TRAINING IN CARDIOPULMONARY REHABILITATION PATIENTS.","PURPOSE
Isometric handgrip (IHG) training lowers systolic and diastolic blood pressure (SBP and DBP, respectively), but the efficacy of IHG training in cardiopulmonary rehabilitation patients is unknown. The purpose of this study was to determine if IHG decreases blood pressure in cardiopulmonary rehabilitation patients.
METHODS
Cardiopulmonary rehabilitation program participants (n = 11; 50-80 yr old) were randomized to IHG (n = 6) or control (CON; no treatment; n = 5) groups. IHG participants completed an IHG training program at 30% maximal voluntary contraction, 3 d/wk for 6 wk. Resting SBP, DBP, and heart rate were assessed weekly.
RESULTS
Mean regression for SBP following IHG was negative (-1.04 ± 0.80). Mean regression in the CON group was positive (0.50 ± 0.88), but there was no significant difference between groups. Separate analysis of weeks 1 to 7 yielded a negative mean regression (-1.12 ± 0.54) in the IHG group, but positive (1.2 ± 0.60) in the CON group. A Wilcoxon test of these differences yielded significance for SBP (P = .009). In 3 of 6 IHG participants, SBP was lower (mean ± SD: -16 ± 11 mm Hg; P = .12), and in 2 IHG participants, DBP was lower (-9 ± 1 mm Hg; P = .06) compared with baseline. In 2 of 5 CON participants, SBP was not significantly lower (-11 ± 7 mm Hg) and, in 3 of 5 CON participants, DBP was lower (-7 ± 4 mm Hg; P = .04).
CONCLUSIONS
Our data suggest that standard IHG training may be inadequate for blood pressure management immediately following a major cardiac or pulmonary event. Future work with a larger cohort and more developed training protocol to determine the efficacy of IHG training in patients with cardiopulmonary disease is warranted.",2019,"Mean regression in the CON group was positive (0.50 ± 0.88), but there was no significant difference between groups.","['cardiopulmonary rehabilitation patients', 'Cardiopulmonary rehabilitation program participants (n = 11; 50-80 yr old', 'patients with cardiopulmonary disease']","['Isometric handgrip (IHG) training', 'standard IHG training', 'IHG training program', 'IHG', 'IHG training']","['blood pressure', 'DBP', 'systolic and diastolic blood pressure (SBP and DBP, respectively', 'Resting SBP, DBP, and heart rate', 'Mean regression', 'SBP']","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]",,0.0299704,"Mean regression in the CON group was positive (0.50 ± 0.88), but there was no significant difference between groups.","[{'ForeName': 'Benjamin D H', 'Initials': 'BDH', 'LastName': 'Gordon', 'Affiliation': 'Departments of Kinesiology (Drs Gordon, Marino, and Howden and Mss Whitmire and Zacherle), Biological Sciences (Drs Leamy and Reitzel), and Psychological Science (Dr Bennett), UNC Charlotte, North Carolina; Carolinas HealthCare System NorthEast, Concord, North Carolina (Mr Doyle and Dr Gulati); Department of Life and Sports Science, University of Greenwich, London, United Kingdom (Dr Swaine); and Department of Exercise and Rehabilitative Sciences, Slippery Rock University, Pennsylvania (Dr Gordon).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Whitmire', 'Affiliation': ''}, {'ForeName': 'Emily W', 'Initials': 'EW', 'LastName': 'Zacherle', 'Affiliation': ''}, {'ForeName': 'Shelton', 'Initials': 'S', 'LastName': 'Doyle', 'Affiliation': ''}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': ''}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Leamy', 'Affiliation': ''}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Marino', 'Affiliation': ''}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Reitzel', 'Affiliation': ''}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Swaine', 'Affiliation': ''}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Howden', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000468']
1515,30685489,"Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised controlled phase 2/3 trial.","BACKGROUND
Laparoscopic pancreatoduodenectomy may improve postoperative recovery compared with open pancreatoduodenectomy. However, there are concerns that the extensive learning curve of this complex procedure could increase the risk of complications. We aimed to assess whether laparoscopic pancreatoduodenectomy could reduce time to functional recovery compared with open pancreatoduodenectomy.
METHODS
This multicentre, patient-blinded, parallel-group, randomised controlled phase 2/3 trial was performed in four centres in the Netherlands that each do 20 or more pancreatoduodenectomies annually; surgeons had to have completed a dedicated training programme for laparoscopic pancreatoduodenectomy and have done 20 or more laparoscopic pancreatoduodenectomies before trial participation. Patients with a benign, premalignant, or malignant indication for pancreatoduodenectomy, without signs of vascular involvement, were randomly assigned (1:1) to undergo either laparoscopic or open pancreatoduodenectomy using a central web-based system. Randomisation was stratified for annual case volume and preoperative estimated risk of pancreatic fistula. Patients were blinded to treatment allocation. Analysis was done according to the intention-to-treat principle. The main objective of the phase 2 part of the trial was to assess the safety of laparoscopic pancreatoduodenectomy (complications and mortality), and the primary outcome of phase 3 was time to functional recovery in days, defined as all of the following: adequate pain control with only oral analgesia; independent mobility; ability to maintain more than 50% of the daily required caloric intake; no need for intravenous fluid administration; and no signs of infection (temperature <38·5°C). This trial is registered with Trialregister.nl, number NTR5689.
FINDINGS
Between May 13 and Dec 20, 2016, 42 patients were randomised in the phase 2 part of the trial. Two patients did not receive surgery and were excluded from analyses in accordance with the study protocol. Three (15%) of 20 patients died within 90 days after laparoscopic pancreatoduodenectomy, compared with none of 20 patients after open pancreatoduodenectomy. Based on safety data from the phase 2 part of the trial, the data and safety monitoring board and protocol committee agreed to proceed with phase 3. Between Jan 31 and Nov 14, 2017, 63 additional patients were randomised in phase 3 of the trial. Four patients did not receive surgery and were excluded from analyses in accordance with the study protocol. After randomisation of 105 patients (combining patients from both phase 2 and phase 3), of whom 99 underwent surgery, the trial was prematurely terminated by the data and safety monitoring board because of a difference in 90-day complication-related mortality (five [10%] of 50 patients in the laparoscopic pancreatoduodenectomy group vs one [2%] of 49 in the open pancreatoduodenectomy group; risk ratio [RR] 4·90 [95% CI 0·59-40·44]; p=0·20). Median time to functional recovery was 10 days (95% CI 5-15) after laparoscopic pancreatoduodenectomy versus 8 days (95% CI 7-9) after open pancreatoduodenectomy (log-rank p=0·80). Clavien-Dindo grade III or higher complications (25 [50%] of 50 patients after laparoscopic pancreatoduodenectomy vs 19 [39%] of 49 after open pancreatoduodenectomy; RR 1·29 [95% CI 0·82-2·02]; p=0·26) and grade B/C postoperative pancreatic fistulas (14 [28%] vs 12 [24%]; RR 1·14 [95% CI 0·59-2·22]; p=0·69) were comparable between groups.
INTERPRETATION
Although not statistically significant, laparoscopic pancreatoduodenectomy was associated with more complication-related deaths than was open pancreatoduodenectomy, and there was no difference between groups in time to functional recovery. These safety concerns were unexpected and worrisome, especially in the setting of trained surgeons working in centres performing 20 or more pancreatoduodenectomies annually. Experience, learning curve, and annual volume might have influenced the outcomes; future research should focus on these issues.
FUNDING
Grant for investigator-initiated studies by Johnson & Johnson Medical Limited.",2019,Median time to functional recovery was 10 days (95% CI 5-15) after laparoscopic pancreatoduodenectomy versus 8 days (95% CI 7-9) after open pancreatoduodenectomy (log-rank p=0·80).,"['42 patients were randomised in the phase 2 part of the trial', 'Patients with a benign, premalignant, or malignant indication for pancreatoduodenectomy, without signs of vascular involvement', 'Between Jan 31 and Nov 14, 2017, 63 additional patients', 'Between May 13 and Dec 20, 2016', '4·90', 'four centres in the Netherlands that each do 20 or more pancreatoduodenectomies annually; surgeons had to have completed a dedicated training programme for laparoscopic pancreatoduodenectomy and have done 20 or more laparoscopic pancreatoduodenectomies before trial participation']","['Laparoscopic pancreatoduodenectomy', 'open pancreatoduodenectomy', 'adequate pain control with only oral analgesia', 'pancreatoduodenectomy', 'laparoscopic pancreatoduodenectomy', 'laparoscopic or open pancreatoduodenectomy using a central web-based system', 'Laparoscopic versus open pancreatoduodenectomy']","['Median time to functional recovery', 'grade B/C postoperative pancreatic fistulas', 'Clavien-Dindo grade III or higher complications', 'time to functional recovery', 'safety of laparoscopic pancreatoduodenectomy (complications and mortality', 'risk of complications', 'postoperative recovery', '90-day complication-related mortality', 'risk ratio [RR', 'complication-related deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441806', 'cui_str': 'Grade B (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",42.0,0.429736,Median time to functional recovery was 10 days (95% CI 5-15) after laparoscopic pancreatoduodenectomy versus 8 days (95% CI 7-9) after open pancreatoduodenectomy (log-rank p=0·80).,"[{'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'van Hilst', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'de Rooij', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Koop', 'Initials': 'K', 'LastName': 'Bosscha', 'Affiliation': ""Department of Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Brinkman', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Marcel G', 'Initials': 'MG', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Research Unit, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Gerhards', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Ignace H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands; Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, Netherlands.'}, {'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Karsten', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lips', 'Affiliation': ""Department of Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands; Department of Surgery, Medisch Spectrum Twente, Enschede, Netherlands.""}, {'ForeName': 'Misha D', 'Initials': 'MD', 'LastName': 'Luyer', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Busch', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Festen', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands. Electronic address: m.g.besselink@amc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30004-4']
1516,30680611,The effects of lutein and zeaxanthin on resting state functional connectivity in older Caucasian adults: a randomized controlled trial.,"The carotenoids lutein (L) and zeaxanthin (Z) accumulate in retinal regions of the eye and have long been shown to benefit visual health. A growing literature suggests cognitive benefits as well, particularly in older adults. The present randomized controlled trial sought to investigate the effects of L and Z on brain function using resting state functional magnetic resonance imaging (fMRI). It was hypothesized that L and Z supplementation would (1) improve intra-network integrity of default mode network (DMN) and (2) reduce inter-network connectivity between DMN and other resting state networks. 48 community-dwelling older adults (mean age = 72 years) were randomly assigned to receive a daily L (10 mg) and Z (2 mg) supplement or a placebo for 1 year. Resting state fMRI data were acquired at baseline and post-intervention. A dictionary learning and sparse coding computational framework, based on machine learning principles, was used to investigate intervention-related changes in functional connectivity. DMN integrity was evaluated by calculating spatial overlap rate with a well-established DMN template provided in the neuroscience literature. Inter-network connectivity was evaluated via time series correlations between DMN and nine other resting state networks. Contrary to expectation, results indicated that L and Z significantly increased rather than decreased inter-network connectivity (Cohen's d = 0.89). A significant intra-network effect on DMN integrity was not observed. Rather than restoring what has been described in the available literature as a ""youth-like"" pattern of intrinsic brain activity, L and Z may facilitate the aging brain's capacity for compensation by enhancing integration between networks that tend to be functionally segregated earlier in the lifespan.",2020,The carotenoids lutein (L) and zeaxanthin (Z) accumulate in retinal regions of the eye and have long been shown to benefit visual health.,"['older Caucasian adults', '48 community-dwelling older adults (mean age\u2009=\u200972\xa0years', 'older adults']","['daily L (10\xa0mg) and Z (2\xa0mg) supplement or a placebo', 'L and Z', 'resting state functional magnetic resonance imaging (fMRI', 'lutein and zeaxanthin', 'carotenoids lutein (L) and zeaxanthin']","['intra-network integrity of default mode network (DMN) and (2) reduce inter-network connectivity', 'inter-network connectivity', 'DMN integrity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}]",48.0,0.151333,The carotenoids lutein (L) and zeaxanthin (Z) accumulate in retinal regions of the eye and have long been shown to benefit visual health.,"[{'ForeName': 'Cutter A', 'Initials': 'CA', 'LastName': 'Lindbergh', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA.'}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Psychiatry and Department of Biomedical Engineering, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Computer Science, 420 Boyd Graduate Studies Research Center, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Mewborn', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA.'}, {'ForeName': 'Antonio N', 'Initials': 'AN', 'LastName': 'Puente', 'Affiliation': 'Psychiatry and Behavioral Sciences, George Washington University, 2120 L St., Suite 600, Washington D.C., 22307, USA.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Terry', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 79/96 Thirteenth Street, Charlestown Navy Yard, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Renzi-Hammond', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA.'}, {'ForeName': 'Billy R', 'Initials': 'BR', 'LastName': 'Hammond', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA.'}, {'ForeName': 'Tianming', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Computer Science, 420 Boyd Graduate Studies Research Center, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'L Stephen', 'Initials': 'LS', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA. lsmiller@uga.edu.'}]",Brain imaging and behavior,['10.1007/s11682-018-00034-y']
1517,25581657,Effects of naltrexone on neural and subjective response to alcohol in treatment-seeking alcohol-dependent patients.,"BACKGROUND
Positively reinforcing properties of alcohol are in part mediated by activation of the ventral striatum (VS). Alcohol-induced release of endogenous opioids is thought to contribute to this response. Preclinical studies show that the opioid antagonist naltrexone (NTX) can block this cascade, but its ability to do so in treatment-seeking alcoholics has not been examined. Our objective was to study the effects of NTX on alcohol-induced VS activation and on amygdala response to affective stimuli in treatment-seeking alcohol-dependent inpatients.
METHODS
Sixty-three treatment-seeking alcoholics were randomized to receive NTX (50 mg) or placebo (PLC) daily. On Day 7, participants underwent an alcohol cue reactivity session, and craving was measured using the Penn Alcohol Craving Scale. On Day 9, participants received a saline infusion followed by an alcohol infusion and also viewed affective stimuli in a magnetic resonance scanner.
RESULTS
Irrespective of medication treatment condition, the alcohol infusion did not activate the VS in the alcohol-dependent patients. Unexpectedly, VS activation was greater in NTX treated patients than in the PLC group. NTX treated patients also reported increased craving in response to alcohol cue exposure, and increased subjective response to alcohol (""high"" and ""intoxicated"") compared to PLC subjects. No significant effects of alcohol infusion on brain response to affective stimuli were in the NTX or PLC groups.
CONCLUSIONS
Unlike previous findings in social drinkers, a moderate level of intoxication did not activate the VS in treatment-seeking alcoholics. This is likely to reflect tolerance to the positively reinforcing properties of alcohol in this clinical population. Our findings may help explain the efficacy of NTX to reduce heavy drinking, but not to maintain abstinence.",2014,"NTX treated patients also reported increased craving in response to alcohol cue exposure, and increased subjective response to alcohol (""high"" and ""intoxicated"") compared to PLC subjects.","['treatment-seeking alcohol-dependent patients', 'treatment-seeking alcohol-dependent inpatients', 'Sixty-three treatment-seeking alcoholics']","['naltrexone', 'saline infusion followed by an alcohol infusion and also viewed affective stimuli in a magnetic resonance scanner', 'opioid antagonist naltrexone (NTX', 'placebo (PLC) daily', 'NTX', 'alcohol infusion']","['neural and subjective response', 'brain response to affective stimuli', 'VS activation', 'craving in response to alcohol cue exposure', 'Penn Alcohol Craving Scale', 'subjective response']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0687725', 'cui_str': 'Alcoholics'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0222045'}]",63.0,0.0145085,"NTX treated patients also reported increased craving in response to alcohol cue exposure, and increased subjective response to alcohol (""high"" and ""intoxicated"") compared to PLC subjects.","[{'ForeName': 'Primavera A', 'Initials': 'PA', 'LastName': 'Spagnolo', 'Affiliation': 'Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Vijay A', 'Initials': 'VA', 'LastName': 'Ramchandani', 'Affiliation': ''}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': ''}, {'ForeName': 'Lishu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Blaine', 'Affiliation': ''}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Usala', 'Affiliation': ''}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Diamond', 'Affiliation': ''}, {'ForeName': 'Monte J', 'Initials': 'MJ', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'George', 'Affiliation': ''}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Momenan', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': ''}]","Alcoholism, clinical and experimental research",['10.1111/acer.12581']
1518,30696387,Exercise-Induced Alterations in Sympathetic-Somatomotor Coupling in Incomplete Spinal Cord Injury.,"The aim of this study was to understand how high- and low-intensity locomotor training (LT) affects sympathetic-somatomotor (SS) coupling in people with incomplete spinal cord injury (SCI). Proper coupling between sympathetic and somatomotor systems allows controlled regulation of cardiovascular responses to exercise. In people with SCI, altered connectivity between descending pathways and spinal segments impairs sympathetic and somatomotor coordination, which may have deleterious effects during exercise and limit rehabilitation outcomes. We postulated that high-intensity LT, which repeatedly engages SS systems, would alter SS coupling. Thirteen individuals (50 ± 7.2 years) with motor incomplete spinal cord injuries (American Spinal Injury Association Impairment Scale C or D; injury level >T6) participated in a locomotor treadmill training program. Patients were randomized into either a high-intensity (high-LT; 70-85% of maximum predicted heart rate; n = 6) group or a low-intensity (low-LT; 50-65% of maximum predicted heart rate; n = 7) group and completed up to 20 LT training sessions over 4-6 weeks, 3-5 days/week. Before and after taining, we tested SS coupling by eliciting reflexive sympathetic activity through a cold stimulation, noxious stimulation, and a mental math task while we measured tendon reflexes, blood pressure, and heart rate. Participants who completed high- versus low-LT exhibited significant decreases in reflex torques during triggered sympathetic activity (cold: -83 vs. 13%, p < 0.01; pain: -65 vs. 54%, p < 0.05; mental math: -43 vs. 41%; p < 0.05). Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant. These results suggest that high-LT may be advantageous to low-LT to improve SS coupling in people with incomplete SCI.",2019,"Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant.","['people with incomplete spinal cord injury (SCI', 'Thirteen individuals (50\u2009±\u20097.2 years) with motor incomplete spinal cord injuries (American Spinal Injury Association Impairment Scale C or D; injury level >T6) participated in a']","['locomotor treadmill training program', 'high- and low-intensity locomotor training (LT']","['tendon reflexes, blood pressure, and heart rate', 'reflex torques during triggered sympathetic activity', 'Mean arterial pressure responses to sympathetic stimuli', 'mental math']","[{'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4720884', 'cui_str': 'American Spinal Injury Association impairment scale (assessment scale)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}]","[{'cui': 'C0034943', 'cui_str': 'Reflex, Tendon'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0799656,"Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Onushko', 'Affiliation': 'Department of Biomedical Engineering, Marquette University, Milwaukee, Wisconsin.'}, {'ForeName': 'Gordhan B', 'Initials': 'GB', 'LastName': 'Mahtani', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Brazg', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, Illinois.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': 'Department of Biomedical Engineering, Marquette University, Milwaukee, Wisconsin.'}]",Journal of neurotrauma,['10.1089/neu.2018.5719']
1519,30686643,Outcomes of Double-patch and Warden Techniques in Patients With Supracardiac Partial Anomalous Pulmonary Venous Connection.,"AIM
This study compared outcomes following the double-patch and Warden procedures for correcting partial anomalous connection of the right pulmonary veins to the superior vena cava.
METHODS
Eighty (80) patients, aged <18years old, and with partial anomalous connection of the right pulmonary veins to the superior vena cava were randomly assigned into double-patch method (n=40) and Warden procedure (n=40) groups. The median follow-up was 22.5 (range, 12-39) months. The primary endpoint was sinus node dysfunction at the mid-term follow-up period.
RESULTS
No early or late mortality occurred. In the early postoperative period, sinus node dysfunction was observed in 27.5% and 5% of cases after double-patch correction and the Warden procedure, respectively (risk ratio, 5.50; 95% confidence interval, 1.30-23.25; p=0.01). At follow-up, sinus node dysfunction persisted in two (5%) patients after double-patch correction. All patients had normal sinus rhythm after the Warden procedure. No early or late pacemaker implantation occurred in either group. No patients had significant pulmonary veins or superior vena cava stenosis.
CONCLUSIONS
The double-patch technique and Warden procedure both showed excellent early and mid-term results with no mortality and minimal morbidity. The Warden procedure was associated with less sinus node dysfunction in the early postoperative period than the double-patch technique. There was no significant between-group difference in sinus node dysfunction at the mid-term follow-up.",2020,The double-patch technique and Warden procedure both showed excellent early and mid-term results with no mortality and minimal morbidity.,"['Eighty patients, aged <18years old, and with partial anomalous connection of the right pulmonary veins to the superior vena cava', 'Patients with Supracardiac Partial Anomalous Pulmonary Venous Connection']","['double-patch method (n=40) and Warden procedure', 'Double-patch and Warden Techniques', 'double-patch and Warden procedures']","['late mortality', 'mortality and minimal morbidity', 'sinus node dysfunction', 'normal sinus rhythm', 'late pacemaker implantation']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0226669', 'cui_str': 'Structure of right pulmonary vein'}, {'cui': 'C0042459', 'cui_str': 'Vena Cava, Superior'}, {'cui': 'C0442190', 'cui_str': 'Supracardiac (qualifier value)'}, {'cui': 'C0158634', 'cui_str': 'Partial anomalous pulmonary venous connection (disorder)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0428908', 'cui_str': 'Sinus Node Disease'}, {'cui': 'C0232202', 'cui_str': 'Normal sinus rhythm (finding)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",,0.0632826,The double-patch technique and Warden procedure both showed excellent early and mid-term results with no mortality and minimal morbidity.,"[{'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Zubritskiy', 'Affiliation': 'Congenital Heart Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation. Electronic address: a_zubritskij@meshalkin.ru.'}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Naberukhin', 'Affiliation': 'Congenital Heart Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Arkhipov', 'Affiliation': 'Congenital Heart Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Gorbatykh', 'Affiliation': 'Congenital Heart Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Khapaev', 'Affiliation': 'Congenital Heart Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Nichay', 'Affiliation': 'Congenital Heart Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Kulyabin', 'Affiliation': 'Congenital Heart Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bogachev-Prokophiev', 'Affiliation': 'Congenital Heart Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Karaskov', 'Affiliation': 'Congenital Heart Surgery Department, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}]","Heart, lung & circulation",['10.1016/j.hlc.2018.11.020']
1520,31397769,Exercise Rehabilitation Improves Cardiac Volumes and Functional Capacity in Patients With Endomyocardial Fibrosis: A RANDOMIZED CONTROLLED TRIAL.,"PURPOSE
Endomyocardial fibrosis (EMF) is a restrictive cardiomyopathy associated with low functional capacity and high mortality rates. Exercise training has been proved to be a nonpharmacological treatment of cardiovascular diseases. Therefore, the purpose of this study was to determine the effects of exercise rehabilitation in EMF patients.
METHODS
Twenty-two EMF patients, functional classes II and III (New York Heart Association [NYHA]), were randomized to the control (C-EMF) or exercise rehabilitation (Rehab-EMF) group. Patients in the Rehab-EMF group underwent 4 mo of exercise rehabilitation, whereas patients in the C-EMF group were instructed to maintain their usual daily routine. Peak oxygen uptake ((Equation is included in full-text article.)O2), cardiac function, and quality of life were evaluated. All assessments were performed at baseline and after 4 mo.
RESULTS
After 4 mo of rehabilitation, peak (Equation is included in full-text article.)O2 increased in the Rehab-EMF group (17.4 ± 3.0 to 19.7 ± 4.4 mL/kg/min, P < .001), whereas the C-EMF group showed no difference (15.3 ± 3.0 to 15.0 ± 2.0 mL/kg/min, P = .87). Also, post-intervention, peak (Equation is included in full-text article.)O2 in the Rehab-EMF group was greater than that in the C-EMF group (P < .001). Furthermore, the Rehab-EMF group, when compared to the C-EMF group, showed an increase in left ventricular end-diastolic volume (102.1 ± 64.6 to 136.2 ± 75.8 mL vs 114.4 ± 55.0 to 100.4 ± 49.9 mL, P < .001, respectively) and decrease in left atrial diastolic volume (69.0 ± 33.0 to 34.9 ± 15.0 mL vs 44.6 ± 21.0 to 45.6 ± 23.0 mL, P < .001, respectively). Quality-of-life scores also improved in the Rehab-EMF group, whereas the C-EMF group showed no change (45 ± 23 to 27 ± 15 vs 47 ± 15 to 45 ± 17, P < .001, respectively).
CONCLUSION
Exercise rehabilitation is a nonpharmacological intervention that improves functional capacity, cardiac volumes, and quality of life in EMF patients after endocardial resection surgery. In addition, exercise rehabilitation should be prescribed to EMF patients to improve their clinical condition.",2019,"Quality-of-life scores also improved in the Rehab-EMF group, whereas the C-EMF group showed no change (45 ± 23 to 27 ± 15 vs 47 ± 15 to 45 ± 17, P < .001, respectively).
","['Patients', 'EMF patients after endocardial resection surgery', 'Twenty-two EMF patients, functional classes II and III', 'EMF patients', 'With Endomyocardial Fibrosis']","['exercise rehabilitation', 'control (C-EMF) or exercise rehabilitation (Rehab-EMF', 'Exercise rehabilitation', 'Exercise training', 'Exercise Rehabilitation']","['Peak oxygen uptake (Vo2), cardiac function, and quality of life', 'peak Vo2', 'Quality-of-life scores', 'functional capacity, cardiac volumes, and quality of life', 'Cardiac Volumes and Functional Capacity', 'left atrial diastolic volume', 'left ventricular end-diastolic volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014124', 'cui_str': 'Endocardium'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0553980', 'cui_str': 'Endomyocardial Fibrosis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0007179', 'cui_str': 'Heart Volume'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}]",,0.0316188,"Quality-of-life scores also improved in the Rehab-EMF group, whereas the C-EMF group showed no change (45 ± 23 to 27 ± 15 vs 47 ± 15 to 45 ± 17, P < .001, respectively).
","[{'ForeName': 'Ana Luiza Carrari', 'Initials': 'ALC', 'LastName': 'Sayegh', 'Affiliation': 'Clinical Unit of Cardiomyopathy, Heart Institute (InCor) (Drs Sayegh and Mady), Cardiovascular Rehabilitation and Exercise Physiology Unit, Heart Institute (InCor-HC-FMUSP) (Drs dos Santos, de Oliveira, and Alves and Messrs Rondon and de Souza), and Clinical Unit of Heart Failure, Heart Institute (InCor) (Dr Salemi), University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Marcelo R', 'Initials': 'MR', 'LastName': 'Dos Santos', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Rondon', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'de Oliveira', 'Affiliation': ''}, {'ForeName': 'Francis R', 'Initials': 'FR', 'LastName': 'de Souza', 'Affiliation': ''}, {'ForeName': 'Vera M C', 'Initials': 'VMC', 'LastName': 'Salemi', 'Affiliation': ''}, {'ForeName': 'Maria-Janieire de N N', 'Initials': 'MNN', 'LastName': 'Alves', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Mady', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000445']
1521,29033718,A randomized comparative study assessing efficacy of pain versus comfort scores.,"CONTEXT
Use of language with negative emotional content is likely to increase patient's pain and anxiety.
AIMS
We designed a single-blinded randomized study to compare pain scores with comfort scores and to determine whether the technique of pain assessment affects patient's perceptions and experience.
SUBJECTS AND METHODS
After cesarean section, 180 women were randomized before postanaesthesia interview into two groups. Group P women were asked to rate their pain on a 0-10-point verbal numerical rating scale (VNRS) for pain while Group C women were asked to rate their comfort on a 0-10-point VNRS for comfort. All women were asked whether the surgical wound was associated with injury or healing. The primary outcomes were to compare the incidence of reported pain and to assess pain severity as measured by a 0-10-point VNRS for pain compared with an equivalent inverted VNRS for comfort. The secondary outcomes were whether the wound was associated with injury or healing.
STATISTICAL ANALYSIS USED
Data were analyzed using Student's t -test and nonparametric Mann-Whitney U-test, performed at a significance level of α =0.05.
RESULTS
In Group P, 62 women (68.9%) reported pain compared with only 49 women (54.4%) in Group C ( P < 0.05). There were no significant differences between groups for VNRS at rest and on movement. In Group P, thirty women (33.33%) reported sensations as injury compared with only 11 women (12.22%) in Group C ( P < 0.001).
CONCLUSIONS
Assessment of pain using positive word like comfort decreases its incidence with no effect on its severity when measured by comfort score and also affects patient's postsurgical perceptions.",2017,There were no significant differences between groups for VNRS at rest and on movement.,"['After cesarean section, 180 women']",[],"['pain', 'rate their pain on a 0-10-point verbal numerical rating scale (VNRS) for pain', 'pain scores with comfort scores', 'injury or healing', 'incidence of reported pain and to assess pain severity']","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",180.0,0.180497,There were no significant differences between groups for VNRS at rest and on movement.,"[{'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Grewal', 'Affiliation': 'Department of Anaesthesia, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_256_17']
1522,32107315,Effectiveness of modified complex decongestive physiotherapy for preventing lower extremity lymphedema after radical surgery for cervical cancer: a randomized controlled trial.,"BACKGROUND
There is a lack of evidence in support of any prophylactic measure to prevent secondary lower extremity lymphedema after radical hysterectomy among patients with cervical cancer. This study aimed to determine the effectiveness of modified complex decongestive physiotherapy in reducing the risk of secondary lower extremity lymphedema after radical surgery.
METHODS
A randomized single-blind clinical trial was conducted in 120 patients with cervical cancer who underwent laparoscopic radical hysterectomy with pelvic lymphadenectomy between January 2016 and April 2017 in the Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China. Participants were randomly assigned to a modified complex decongestive physiotherapy intervention group (n=60) or control group (n=60). The intervention group received a modified complex decongestive physiotherapy program, which included manual lymph drainage, compression hosiery, regular exercise, and health education. The control group only received a health education program. The main outcome was the incidence of secondary lower extremity lymphedema.
RESULTS
A total of 117 patients with cervical cancer completed a 1-year follow-up. Twenty-eight (23.9%) patients developed secondary lower extremity lymphedema (20 (34.5%) patients in the control group and 8 (13.6%) in the intervention group). The incidence of secondary lower extremity lymphedema was significantly higher in the control group than in the intervention group (p=0.008; OR 0.30 (95% CI 0.12 to 0.75). The median percentage of excess volume was significantly less in the intervention group (2.1%, IQR 0.5-3.4%) than in the control group (2.96%, IQR 1.1-4.98%); (p = 0.042). The mean (SD) onset time of lymphedema was 8 (2.00) months vs 4.6 (2.82) months in the intervention and control groups, respectively (p=0.004).
CONCLUSIONS
This randomized trial showed that modified complex decongestive physiotherapy is effective for preventing lower extremity lymphedema in patients with cervical cancer after laparoscopic radical hysterectomy with pelvic lymphadenectomy.",2020,The incidence of secondary lower extremity lymphedema was significantly higher in the control group than in the intervention group (p=0.008; OR 0.30,"['lower extremity lymphedema after radical surgery for cervical cancer', '120 patients with cervical cancer who underwent', 'patients with cervical cancer after laparoscopic radical hysterectomy with pelvic lymphadenectomy', 'patients with cervical cancer', 'between January 2016 and April 2017 in the Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China', '117 patients with cervical cancer completed a 1-year follow-up']","['radical hysterectomy', 'modified complex decongestive physiotherapy', 'modified complex decongestive physiotherapy program, which included manual lymph drainage, compression hosiery, regular exercise, and health education', 'modified complex decongestive physiotherapy intervention group (n=60) or control group', 'health education program', 'laparoscopic radical hysterectomy with pelvic lymphadenectomy']","['extremity lymphedema', 'mean (SD) onset time of lymphedema', 'incidence of secondary lower extremity lymphedema', 'secondary lower extremity lymphedema', 'median percentage of excess volume']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404093', 'cui_str': 'Laparoscopic radical hysterectomy (procedure)'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy (procedure)'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0556834', 'cui_str': 'Manual Lymphatic Drainage'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0453907', 'cui_str': 'Hosiery (physical object)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0018701'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0404093', 'cui_str': 'Laparoscopic radical hysterectomy (procedure)'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy (procedure)'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",120.0,0.0627603,The incidence of secondary lower extremity lymphedema was significantly higher in the control group than in the intervention group (p=0.008; OR 0.30,"[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Nursing, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China jonish@vip.sina.com.'}, {'ForeName': 'Hui-Yuan', 'Initials': 'HY', 'LastName': 'Cai', 'Affiliation': 'Department of Lymphedema Rehabilitation Clinic, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Fang-Qin', 'Initials': 'FQ', 'LastName': 'Fan', 'Affiliation': 'Department of Lymphedema Rehabilitation Clinic, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Zhi-Fang', 'Initials': 'ZF', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'An', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000911']
1523,31821151,Effectiveness and Cost-Effectiveness of a Self-Guided Internet Intervention for Social Anxiety Symptoms in a General Population Sample: Randomized Controlled Trial.,"BACKGROUND
Many people are accessing digital self-help for mental health problems, often with little evidence of effectiveness. Social anxiety is one of the most common sources of mental distress in the population, and many people with symptoms do not seek help for what represents a significant public health problem.
OBJECTIVE
This study aimed to evaluate the effectiveness of a self-guided cognitive behavioral internet intervention for people with social anxiety symptoms in the general population.
METHODS
We conducted a two-group randomized controlled trial in England between May 11, 2016, and June 27, 2018. Adults with social anxiety symptoms who were not receiving treatment for social anxiety were recruited using online advertisements. All participants had unrestricted access to usual care and were randomized in a 1:1 ratio to either a Web-based unguided self-help intervention based on cognitive behavioral principles or a waiting list control group. All outcomes were collected through self-report online questionnaires. The primary outcome was the change in 17-item Social Phobia Inventory (SPIN-17) score from baseline to 6 weeks using a linear mixed-effect model that used data from all time points (6 weeks, 3 months, 6 months, and 12 months).
RESULTS
A total of 2122 participants were randomized, and 6 were excluded from analyses because they were ineligible. Of the 2116 eligible randomized participants (mean age 37 years; 80.24%, 1698/2116 women), 70.13% (1484/2116) had follow-up data available for analysis, and 56.95% (1205/2116) had data on the primary outcome, although attrition was higher in the intervention arm. At 6 weeks, the mean (95% CI) adjusted difference in change in SPIN-17 score in the intervention group compared with control was -1.94 (-3.13 to -0.75; P=.001), a standardized mean difference effect size of 0.2. The improvement was maintained at 12 months. Given the high dropout rate, sensitivity analyses explored missing data assumptions, with results that were consistent with those of the primary analysis. The economic evaluation demonstrated cost-effectiveness with a small health status benefit and a reduction in health service utilization.
CONCLUSIONS
For people with social anxiety symptoms who are not receiving other forms of help, this study suggests that the use of an online self-help tool based on cognitive behavioral principles can provide a small improvement in social anxiety symptoms compared with no intervention, although dropout rates were high.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02451878; https://clinicaltrials.gov/ct2/show/NCT02451878.",2020,"At 6 weeks, the mean (95% CI) adjusted difference in change in SPIN-17 score in the intervention group compared with control was -1.94","['Adults with social anxiety symptoms who were not receiving treatment for social anxiety were recruited using online advertisements', 'people with social anxiety symptoms who are not receiving other forms of help', '2116 eligible randomized participants (mean age 37 years; 80.24%, 1698/2116 women), 70.13% (1484/2116) had follow-up data available for analysis, and 56.95% (1205/2116) had data on the primary outcome, although attrition was higher in the intervention arm', 'England between May 11, 2016, and June 27, 2018', 'A total of 2122 participants were randomized, and 6 were excluded from analyses because they were ineligible', 'people with social anxiety symptoms in the general population', 'All participants had unrestricted access to usual care', 'Social Anxiety Symptoms in a General Population Sample']","['Self-Guided Internet Intervention', 'Web-based unguided self-help intervention based on cognitive behavioral principles or a waiting list control group', 'self-guided cognitive behavioral internet intervention']","['SPIN-17 score', 'Effectiveness and Cost-Effectiveness', 'social anxiety symptoms', 'change in 17-item Social Phobia Inventory (SPIN-17) score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2919658', 'cui_str': 'Social phobia inventory'}]",2122.0,0.256543,"At 6 weeks, the mean (95% CI) adjusted difference in change in SPIN-17 score in the intervention group compared with control was -1.94","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, Faculty of Education and Professional Studies, Nipissing University, North Bay, ON, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Atherton', 'Affiliation': 'Unit of Academic Primary Care, Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'eHub Health Pty Ltd, Goulburn NSW, Australia.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Davoudianfar', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Hellsing', 'Affiliation': 'Research School of Psychology, Australian National University, Canberra, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mollison', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Milensu', 'Initials': 'M', 'LastName': 'Shanyinde', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Griffiths', 'Affiliation': 'Research School of Psychology, Australian National University, Canberra, Australia.'}]",Journal of medical Internet research,['10.2196/16804']
1524,30520702,The reliability of evaluating conversations between people with traumatic brain injury and their communication partners via videoconferencing.,"There is growing interest in using telehealth to work with people with traumatic brain injury (TBI). This study investigated whether established rating scales for evaluating conversations of people with TBI are reliable for use over videoconferencing. Nineteen participants with TBI and their communication partners completed two conversation samples during both in-person (IP) and videoconferencing-based (VC) assessment, with randomised order of assessment. Independent clinicians evaluated the conversations using the Adapted Measure of Participation in Conversation (MPC), the Adapted Measure of Support in Conversation (MSC) and the Global Impression scales. Comparisons between IP and VC ratings identified no significant differences on the MPC, MSC, and four out of five of the Global Impression scales. There was a significant difference between IP and VC recordings for ""Task Completion"" ( p = .047), with participants performing significantly better in VC ratings. Inter-rater reliability was fair to excellent for the MPC and Global Impression scales for both IP and VC recordings. For the MSC scale, inter-rater reliability was poor to excellent. This study confirms the potential for using videoconferencing for evaluating conversations of people with TBI. Further development of training and rating procedures for these scales could facilitate more frequent and reliable use of these measures.",2020,"There was a significant difference between IP and VC recordings for ""Task Completion"" (p = .047), with participants performing significantly better in VC ratings.","['people with traumatic brain injury (TBI', 'Nineteen participants with TBI and their communication partners', 'people with TBI', 'people with traumatic brain injury and their communication partners via videoconferencing']","['videoconferencing', 'videoconferencing-based (VC) assessment']","['Participation in Conversation (MPC), the Adapted Measure of Support in Conversation (MSC) and the Global Impression scales', 'VC ratings', 'MPC and Global Impression scales']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}]",19.0,0.0271059,"There was a significant difference between IP and VC recordings for ""Task Completion"" (p = .047), with participants performing significantly better in VC ratings.","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Rietdijk', 'Affiliation': 'The University of Sydney, Faculty of Health Sciences, Sydney, NSW, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Power', 'Affiliation': 'The University of Sydney, Faculty of Health Sciences, Sydney, NSW, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brunner', 'Affiliation': 'The University of Sydney, Faculty of Health Sciences, Sydney, NSW, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'The University of Sydney, Faculty of Health Sciences, Sydney, NSW, Australia.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2018.1554533']
1525,31657590,ENHANCE: Evidence for the efficacy of a comprehensive intervention program to promote subjective well-being.,"Building from the growing empirical science of happiness, or subjective well-being (SWB), we have developed a 12-week comprehensive intervention program-Enduring Happiness and Continued Self-Enhancement (ENHANCE)-to increase SWB and enable a thorough examination of the mechanistic processes of program content and administrative structure for SWB change over time. In a randomized controlled trial, participants (N = 155; 55 using the in-person format, 100 online format) were randomly assigned to participate in ENHANCE or to a waitlist control condition. All participants completed assessments of SWB, including non-self-report measures, and process variables at baseline, posttest, and follow-up (3 months). We found evidence supporting the efficacy of ENHANCE for increasing SWB, whether administered in-person or online. Furthermore, development of the skills targeted in the program (e.g., gratitude, mindfulness) accounted for SWB improvements. This study provides initial evidence that ENHANCE can promote SWB and offers insights regarding the processes involved in these changes. To bolster these findings, we present additional data (n = 74) from a fourth assessment showing within-person maintenance of SWB gains over 6 months in the original treatment condition (n = 39) and a replication of the immediate ENHANCE treatment effects in the waitlist condition (n = 36). We discuss potential avenues for the utilization of ENHANCE in basic research and applied disseminations. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Building from the growing empirical science of happiness, or subjective well-being (SWB), we have developed a 12-week comprehensive intervention program-Enduring Happiness and Continued Self-Enhancement (ENHANCE)-to increase SWB and enable a thorough examination of the mechanistic processes of program content and administrative structure for SWB change over time.","['participants (N = 155; 55 using the in-person format, 100 online format']","['comprehensive intervention program', 'waitlist control condition']",[],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],2019.0,0.0323261,"Building from the growing empirical science of happiness, or subjective well-being (SWB), we have developed a 12-week comprehensive intervention program-Enduring Happiness and Continued Self-Enhancement (ENHANCE)-to increase SWB and enable a thorough examination of the mechanistic processes of program content and administrative structure for SWB change over time.","[{'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Heintzelman', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kostadin', 'Initials': 'K', 'LastName': 'Kushlev', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Lesley D', 'Initials': 'LD', 'LastName': 'Lutes', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Wirtz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Kanippayoor', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Leitner', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Oishi', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Diener', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000254']
1526,32407901,A novel extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: A randomized trial.,"OBJECTIVES
Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated with a significant reduction in intra-amniotic infection and improved neonatal outcome. However, data is insufficient to determine the optimal antibiotic regimen. Considering the rise in Escherichia coli and Klebsiella pneumonia early-onset sepsis rate and the emergence of ampicillin resistance, our aim is to compare the efficiency of two antibiotic regimens in prolonging pregnancy and reducing infectious morbidity.
DESIGN
This multicenter randomized unblinded controlled prospective trial compared two antibiotic prophylactic protocols in PPROM: ampicillin + roxithromycin vs. cefuroxime + roxithromycin in 84 women with PPROM, from 12/2015-12/2019.
RESULTS
The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days). Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation, were similar between the groups. K. pneumonia cultures were significantly more frequent in the ampicillin + roxithromycin group. None of the cultures were group B Streptococcus positive.
CONCLUSIONS
To prolong latency period and reduce gram-negative early-onset sepsis, cefuroxime + roxithromycin is recommended as the first-line protocol in PPROM.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02819570.",2020,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"['preterm pre-labor rupture of membranes', 'PPROM', '84 women with PPROM, from 12/2015-12/2019', 'preterm pre-labor rupture of membranes (PPROM']","['ampicillin\u2009+\u2009roxithromycin vs cefuroxime\u2009+\u2009roxithromycin', 'ampicillin\u2009+\u2009roxithromycin', 'cefuroxime\u2009+\u2009roxithromycin', 'prophylactic antibiotic regimen']","['K. pneumonia cultures', 'median latency period', 'Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0035891', 'cui_str': 'Roxithromycin'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023103', 'cui_str': 'Latency Period (Psychology)'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0235839', 'cui_str': 'Fever of the newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",84.0,0.100097,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"[{'ForeName': 'Maya Frank', 'Initials': 'MF', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel. Electronic address: homesickid@yahoo.com.'}, {'ForeName': 'Inshirah', 'Initials': 'I', 'LastName': 'Sgayer', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Miron', 'Affiliation': 'Department of Pediatrics A, Emek Medical Center, Afula, Israel; Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Krencel', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Vered Fleisher', 'Initials': 'VF', 'LastName': 'Sheffer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Neonatal Intensive Care Unit, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Suraya Saied', 'Initials': 'SS', 'LastName': 'Idriss', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'Rami N', 'Initials': 'RN', 'LastName': 'Sammour', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peleg', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Inbar Ben', 'Initials': 'IB', 'LastName': 'Shachar', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Rechnitzer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Clinical Microbiology Laboratory, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bornstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.005']
1527,30687808,Randomised trial of two embolic agents for uterine artery embolisation for fibroids: Gelfoam versus Embospheres (RAGE trial).,"Background
Uterine artery embolisation (UAE) is an established treatment option for women with symptomatic uterine fibroids who wish to avoid surgery. However the most efficacious embolic agent remains uncertain.
Methods
We conducted a pilot double blind randomized controlled trial comparing Gelfoam with Embospheres in women undergoing UAE. Outcomes recorded at baseline, 24-h, 1 and 6 months included complications, inflammatory, haematological markers and ovarian function. Contrast enhanced MRI (CEMRI) was acquired at baseline, 24-h and 6 months. Pain score (visual analogue) was measured at 24-h, quality of life (UFS-Qol) at baseline, 1 and 6 months. All patients were followed to 6 months.
Results
Twenty patients were randomized 1:1 to receive either Gelfoam (G) or Embospheres (E). The UFS-Qol symptom score improved in both groups at 6 months mean of 64 ± 18 to 23 ± 16 and 54 ± 15 to 32 ± 26 in the E and G groups respectively. UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.Uterine volume at 6 months reduced from 1018 ± 666mls to 622 ± 436 ( p = 0.001) and from 1026 ± 756 to 908 ± 720 ( p = 0.15) in the E and G groups respectively. There was a significant difference between groups for this parameter p = 0.01. All uterine arteries were patent at 24-h and 6 months. Complete (100%) fibroid infarction rates were 5(50%) and 2(20%) in the E and G groups respectively. None of the other outcome measures showed any between group differences. There were no re-interventions in either group.
Conclusion
The only significant between group differences was for a greater reduction in uterine volume at 6 months in the E group. A larger trial (estimate 172 subjects) is required to determine whether other apparent differences are clinically and statistically significant.
Trial registration
ISRCTN67347987.",2019,"UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.","['women with symptomatic uterine fibroids who wish to avoid surgery', 'uterine artery embolisation for fibroids', 'Twenty patients', 'women undergoing UAE']","['embolic agents', 'Gelfoam (G) or Embospheres (E', 'Gelfoam with Embospheres', '\n\n\nUterine artery embolisation (UAE']","['Uterine volume', 'complications, inflammatory, haematological markers and ovarian function', 'quality of life (UFS-Qol', 'Contrast enhanced MRI (CEMRI', 'UFS-Qol HRQL', 'UFS-Qol symptom score', 'uterine volume', 'Pain score (visual analogue', 'fibroid infarction rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C1566002', 'cui_str': 'Embospheres'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}]",20.0,0.257914,"UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yadavali', 'Affiliation': '6Radiology department, Gartnavel General Hospital, 1053 Great Western Rd, Glasgow, G12 OYN UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ananthakrishnan', 'Affiliation': '6Radiology department, Gartnavel General Hospital, 1053 Great Western Rd, Glasgow, G12 OYN UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': '6Radiology department, Gartnavel General Hospital, 1053 Great Western Rd, Glasgow, G12 OYN UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Monaghan', 'Affiliation': '2School of Mathematics and Statistics, University of Glasgow, Glasgow, G12 8QW UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McNaught', 'Affiliation': ""3Clinical Research Imaging Centre, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hamoodi', 'Affiliation': 'University Department of Obstetrics and Gynaecology, Glasgow, New Lister Building, 10-16 Alexandra Parade, Glasgow, G31 2ER UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bryden', 'Affiliation': 'Radiology department, Stobhill ACH Hospital, 133 Balornock Road, Glasgow, G21 3UW UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lassman', 'Affiliation': 'Radiology department, Stobhill ACH Hospital, 133 Balornock Road, Glasgow, G21 3UW UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Moss', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, 126 University Place, Glasgow, G12 8TA UK.'}]",CVIR endovascular,['10.1186/s42155-018-0044-y']
1528,32408011,"Cold versus hot adenoidectomy: A prospective, randomized controlled trial.","OBJECTIVE
Adenoidectomy can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and postoperative outcomes. However, the long-term clinical outcome of improving sleep disorder symptoms has not been well established. The objective of this study was to compare outcomes of hot method and cold method adenoidectomy one year following the surgery.
STUDY DESIGN
A prospective, randomized, single-blinded study of children under age 16 years who underwent adenoidectomy during the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques.
SETTING
A tertiary health care referral center.
SUBJECTS AND METHODS
The final analysis included 58 children, mean age 5.9 years (range 1.2-15). The primary outcome was change in the Pediatric Sleep Questionnaire (PSQ) scores one month and one year after surgery. The secondary outcome was complication rate.
RESULTS
Clinical and demographic parameters were similar between the patients in the hot method group (n = 30) and the cold method group (n = 28). Adenoid size and estimated bleeding were similar between the groups. At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54). Improvement in PSQ scores was greater following hot than cold adenoidectomy at one year after surgery (+0.31 points vs. +0.22 points, p = 0.009).
CONCLUSION
Hot adenoidectomy is associated with better outcome than the cold technique, as reflected by PSQ scores one year after the surgery.",2020,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","['A tertiary health care referral center', 'children under age 16 years who underwent adenoidectomy during the years 2014-2017', '58 children, mean age 5.9 years (range 1.2-15']","['hot method and cold method adenoidectomy', 'Cold versus hot adenoidectomy', 'cold adenoidectomy', 'Hot adenoidectomy', 'hot or cold adenoidectomy techniques']","['sleep disorder symptoms', 'Pediatric Sleep Questionnaire (PSQ) scores', 'complication rate', 'PSQ scores', 'PSQ score', 'Adenoid size and estimated bleeding']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0426463', 'cui_str': 'Adenoids size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",58.0,0.101449,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","[{'ForeName': 'Shorook', 'Initials': 'S', 'LastName': ""Na'ara"", 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Sayegh', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Nassar', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shinnawi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gil', 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Gordin', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel. Electronic address: a_gordin@rambam.health.gov.il.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110087']
1529,30499837,"Analgesic Potentials of Preoperative Oral Pregabalin, Intravenous Magnesium Sulphate and their Combination in Acute Post-thoracotomy Pain.","OBJECTIVES
To investigate the effects of the preoperative combination of oral pregabalin and intravenous magnesium sulphate as analgesic adjuvants in post thoracotomy pain.
METHODS
One hundred and twenty patients with ASA physical status II were allocated randomly into one of four groups. Group MP received 300▒mg pregabalin orally and an intravenous (IV) infusion of magnesium sulphate 50▒mg/kg mixed with 200▒mL normal saline (NS); Group P received 300▒mg pregabalin orally and 200▒mL NS infusion; Group M received an IV infusion of magnesium sulphate 50▒mg/kg mixed with 200▒mL NS and a placebo capsule; and Group C received placebo capsule and an IV infusion of 200▒mL NS. All medications were given 1 hour before surgery in all groups. In the first 24 hours postoperatively, total morphine consumption, the visual analogue scale (0-10 VAS) - used as a pain measurement tool - and postoperative nausea and vomiting (PONV) were assessed .
RESULTS
The total morphine consumption in the 1st 24 hours postoperatively decreased significantly in group MP (28.47±5.76▒mg) compared with group P (33.97±6.34▒mg), group M (40.87±4.4▒mg) and group C (42.2±6.1▒mg), respectively. VAS scores were in the accepted range (≤4) in the four groups throughout the first 24 hours, as all patients were on patient controlled analgesia (PCA). However, there was a statistically significant difference at 0 and 4 hours postoperatively in favor of groups MP and P. PONV decreased significantly in groups MP, P and M in comparison to group C (P <0.001).
CONCLUSION
The combined preoperative single dose of Pregabalin and magnesium sulphate is an effective method for attenuating postoperative pain and total morphine consumption in patients undergoing thoracotomy.",2018,"The total morphine consumption in the 1st 24 hours postoperatively decreased significantly in group MP (28.47±5.76▒mg) compared with group P (33.97±6.34▒mg), group M (40.87±4.4▒mg) and group C (42.2±6.1▒mg), respectively.","['patients undergoing thoracotomy', 'One hundred and twenty patients with ASA physical status II', 'Acute Post-thoracotomy Pain']","['Pregabalin, Intravenous Magnesium Sulphate', 'mL normal saline (NS); Group P received 300▒mg pregabalin', 'oral pregabalin and intravenous magnesium sulphate', 'magnesium sulphate 50▒mg/kg mixed with 200▒mL NS and a placebo capsule', 'pregabalin', 'magnesium sulphate 50▒mg/kg mixed with 200▒', 'Pregabalin and magnesium sulphate', 'placebo capsule and an IV infusion of 200▒mL NS']","['total morphine consumption, the visual analogue scale (0-10 VAS) - used as a pain measurement tool - and postoperative nausea and vomiting (PONV', 'VAS scores', 'postoperative pain and total morphine consumption', 'total morphine consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",120.0,0.18884,"The total morphine consumption in the 1st 24 hours postoperatively decreased significantly in group MP (28.47±5.76▒mg) compared with group P (33.97±6.34▒mg), group M (40.87±4.4▒mg) and group C (42.2±6.1▒mg), respectively.","[{'ForeName': 'Ahmed Salah', 'Initials': 'AS', 'LastName': 'Ahmed', 'Affiliation': 'National Cancer Institute, Cairo University, Egypt.'}, {'ForeName': 'Aktham Adel', 'Initials': 'AA', 'LastName': 'Shoukry', 'Affiliation': 'Anesthesia, ICU& Pain management, Faculty of Medicine, Ain Shams University,Egypt.'}, {'ForeName': 'Mahmoud Ahmed Mohammed', 'Initials': 'MAM', 'LastName': 'Kamel', 'Affiliation': 'Anesthesiology and pain relief, National Cancer Institute, Cairo University, Egypt.'}, {'ForeName': 'Ashraf Mohammed Yehia', 'Initials': 'AMY', 'LastName': 'Heikal', 'Affiliation': 'Anesthesiology and pain relief, National Cancer Institute, Cairo University, Egypt.'}, {'ForeName': 'Naglaa Abdulla', 'Initials': 'NA', 'LastName': 'Ahmed', 'Affiliation': 'Anesthesiology and pain relief, National Cancer Institute, Cairo University, Egypt.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000673']
1530,30412234,Individual-level determinants of waterpipe smoking demand in four Eastern-Mediterranean countries.,"The prevalence of waterpipe tobacco smoking in the Eastern Mediterranean Region is at alarmingly high levels, especially among young people. The objective of this research was to evaluate the preferences of young adult waterpipe smokers with respect to potential individual-level determinants of waterpipe smoking using discrete choice experiment methodology. Participants were young adult university students (18-29 years) who were ever waterpipe smokers, recruited from universities across four Eastern Mediterranean countries: Jordan, Oman, Palestine and the United Arab Emirates. The Internet-based discrete choice experiment, with 6 × 3 × 2 block design, evaluated preferences for choices of waterpipe smoking sessions, presented on hypothetical waterpipe café menus. Participants evaluated nine choice sets, each with five fruit-flavored options, a tobacco flavored option (non-flavored), and an opt-out option. Choices also varied based on nicotine content (0.0% vs. 0.05% vs. 0.5%) and price (low vs. high). Participants were randomized to receive menus with either a pictorial + text health-warning message or no message (between-subjects attribute). Multinomial logit regression models evaluated the influence of these attributes on waterpipe smoking choices. Across all four samples (n = 1859), participants preferred fruit-flavored varieties to tobacco flavor, lower nicotine content and lower prices. Exposure to the health warning did not significantly predict likelihood to opt-out. Flavor accounted for 81.4% of waterpipe smoking decisions. Limiting the use of fruit flavors in waterpipe tobacco, in addition to accurate nicotine content labeling and higher pricing may be effective at curbing the demand for waterpipe smoking among young adults.",2019,Exposure to the health warning did not significantly predict likelihood to opt-out.,"['young adults', 'young adult waterpipe smokers', 'Participants evaluated nine choice sets, each with five fruit-flavored options, a tobacco flavored option (non-flavored), and an opt-out option', 'four Eastern-Mediterranean countries', 'Participants were young adult university students (18-29\u2009years) who were ever waterpipe smokers, recruited from universities across four Eastern Mediterranean countries: Jordan, Oman, Palestine and the United Arab Emirates']",['pictorial + text health-warning message or no message'],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0028971', 'cui_str': 'Oman'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],,0.011666,Exposure to the health warning did not significantly predict likelihood to opt-out.,"[{'ForeName': 'Ramzi G', 'Initials': 'RG', 'LastName': 'Salloum', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, 2004 Mowry Road, Gainesville, FL, USA.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Nakkash', 'Affiliation': 'Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, PO Box 11-0236, Riad El-Solh, 1107 2020 Beirut, Lebanon.'}, {'ForeName': 'Niveen M E', 'Initials': 'NME', 'LastName': 'Abu-Rmeileh', 'Affiliation': 'Institute of Community and Public Health, Birzeit University, PO Box 14, Birzeit, Palestine.'}, {'ForeName': 'Randah R', 'Initials': 'RR', 'LastName': 'Hamadeh', 'Affiliation': 'College of Medicine and Medical Sciences, Arabian Gulf University, Road 2904, 293 Manama, Bahrain.'}, {'ForeName': 'Muhammad W', 'Initials': 'MW', 'LastName': 'Darawad', 'Affiliation': 'School of Nursing, The University of Jordan, Queen Rania Street, 11942 Amman, Jordan.'}, {'ForeName': 'Khalid A', 'Initials': 'KA', 'LastName': 'Kheirallah', 'Affiliation': 'Department of Public Health, Community Medicine, Jordan University of Science and Technology, PO Box 3030, 22110 Irbid, Jordan.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Al-Farsi', 'Affiliation': 'Department of Family Medicine and Public Health, College of Medicine and Health Sciences, Sultan Qaboos University, PO Box 35, 123, Al Khod, Muscat, Oman.'}, {'ForeName': 'Afzalhussein', 'Initials': 'A', 'LastName': 'Yusufali', 'Affiliation': 'Hatta Hospital, Dubai Health Authority and Dubai Medical College, 35th Street, PO Box 2017, Dubai, United Arab Emirates.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology, College of Natural and Health Sciences, Zayed University, Khalifa City, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Mostafa', 'Affiliation': 'Department of Community, Environmental, and Occupational Medicine, Faculty of Medicine, Ain Shams University, Abbassiya, 11566 Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Salama', 'Affiliation': 'Medical Experimental Research Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'El Kadi', 'Affiliation': 'Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, PO Box 11-0236, Riad El-Solh, 1107 2020 Beirut, Lebanon.'}, {'ForeName': 'Sukaina', 'Initials': 'S', 'LastName': 'Alzyoud', 'Affiliation': 'Department of Community and Mental Health Nursing, Faculty of Nursing, Hashemite University, PO Box 330127, 13133 Zarqa, Jordan.'}, {'ForeName': 'Nihaya', 'Initials': 'N', 'LastName': 'Al-Sheyab', 'Affiliation': 'Department of Maternal and Child Nursing, Jordan University of Science and Technology, PO Box 3030, 22110 Irbid, Jordan.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Thrasher', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, 29208 Columbia, SC, USA.'}]",Health promotion international,['10.1093/heapro/day084']
1531,31399906,A randomized phase 2 trial of apatinib vs observation as maintenance treatment following first-line induction chemotherapy in extensive- stage small cell lung cancer.,"Background The 5-year survival rate for extensive-disease small-cell lung carcinoma (ED-SCLC) is only 1%. Recently, apatinib exerted promising effects on cancer patients after failure of first-line chemotherapy. Methods This study enrolled 24 ED-SCLC patients to study the efficacy and toxicity of apatinib in combination with chemotherapy and maintenance therapy. The primary endpoints were overall survival (OS) and progression-free survival (PFS). The secondary endpoints included toxicity and safety. Apatinib was given 250 mg/day during the chemotherapy interval, and as maintenance therapy after 4-6 cycles until the patient progressed, died, or was intolerant to drug toxicity. The study further evaluated the cytotoxicity, cell-cycle arrest and apoptotic induction of apatinib in A549 and H446 cells. Results There was no difference in short-term efficacy between combined and chemotherapy groups. Long-term efficacy showed that the median PFS was 7.8 months and 4.9 months in combination and chemotherapy groups, respectively [p = 0.002, HR(95%CI): 0.18(0.06-0.60)]. The median OS was 12.1 months and 8.2 months in combination and chemotherapy groups, respectively [p = 0.023, HR(95%CI): 0.38 (0.16-0.90)]. Multivariate Cox regression analysis showed that apatinib combined with chemotherapy was an independent prognostic factor for OS and PFS. The ECOG score was an independent prognostic factor affecting OS. In vitro analysis showed that apatinib inhibited cell proliferation and caused cell-cycle arrest and apoptosis. Conclusion Apatinib combination/maintenance therapy showed promising efficacy and safety to extend OS/PFS in ED-SCLC and will be a potent therapeutic option in future practice. Although the scale of this study is small, further research on large sample sizes is needed.",2020,There was no difference in short-term efficacy between combined and chemotherapy groups.,"['enrolled 24 ED-SCLC patients', 'extensive- stage small cell lung cancer', 'cancer patients after failure of first-line chemotherapy']","['chemotherapy and maintenance therapy', 'line induction chemotherapy', 'apatinib vs observation']","['cytotoxicity, cell-cycle arrest and apoptotic induction of apatinib in A549 and H446 cells', 'median PFS', 'toxicity and safety', '5-year survival rate', 'efficacy and toxicity', 'cell proliferation and caused cell-cycle arrest and apoptosis', 'median OS', 'efficacy and safety', 'short-term efficacy', 'overall survival (OS) and progression-free survival (PFS', 'ECOG score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C2346836', 'cui_str': '3-Pyridinecarboxamide, N-(4-(1-cyanocyclopentyl)phenyl)-2-((4-methyl-3-pyridinyl)amino)-'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C1155873', 'cui_str': 'Cell Cycle Arrest'}, {'cui': 'C2346836', 'cui_str': '3-Pyridinecarboxamide, N-(4-(1-cyanocyclopentyl)phenyl)-2-((4-methyl-3-pyridinyl)amino)-'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",24.0,0.0780775,There was no difference in short-term efficacy between combined and chemotherapy groups.,"[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Shiheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Chengyuan', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Dai', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, Chongqing, 400042, China. dn400042@hotmail.com.'}]",Investigational new drugs,['10.1007/s10637-019-00828-x']
1532,30811282,Evaluation of Intense Androgen Deprivation Before Prostatectomy: A Randomized Phase II Trial of Enzalutamide and Leuprolide With or Without Abiraterone.,"PURPOSE
Patients with locally advanced prostate cancer have an increased risk of cancer recurrence and mortality. In this phase II trial, we evaluate neoadjuvant enzalutamide and leuprolide (EL) with or without abiraterone and prednisone (ELAP) before radical prostatectomy (RP) in men with locally advanced prostate cancer.
PATIENTS AND METHODS
Eligible patients had a biopsy Gleason score of 4 + 3 = 7 or greater, prostate-specific antigen (PSA) greater than 20 ng/mL, or T3 disease (by prostate magnetic resonance imaging). Lymph nodes were required to be smaller than 20 mm. Patients were randomly assigned 2:1 to ELAP or EL for 24 weeks followed by RP. All specimens underwent central pathology review. The primary end point was pathologic complete response or minimal residual disease (residual tumor ≤ 5 mm). Secondary end points were PSA, surgical staging, positive margins, and safety. Biomarkers associated with pathologic outcomes were explored.
RESULTS
Seventy-five patients were enrolled at four centers. Most patients had high-risk disease by National Comprehensive Cancer Network criteria (n = 65; 87%). The pathologic complete response or minimal residual disease rate was 30% (n = 15 of 50) in ELAP-treated patients and 16% (n = four of 25) in EL-treated patients (two-sided P = .263). Rates of ypT3 disease, positive margins, and positive lymph nodes were similar between arms. Treatment was well-tolerated. Residual tumors in the two arms showed comparable levels of ERG, PTEN, androgen receptor PSA, and glucocorticoid receptor expression. Tumor ERG positivity and PTEN loss were associated with more extensive residual tumors at RP.
CONCLUSION
Neoadjuvant hormone therapy followed by RP in locally advanced prostate cancer resulted in favorable pathologic responses in some patients, with a trend toward improved pathologic outcomes with ELAP. Longer follow-up is necessary to evaluate the impact of therapy on recurrence rates. The potential association of ERG and PTEN alterations with worse outcomes warrants additional investigation.",2019,"Rates of ypT3 disease, positive margins, and positive lymph nodes were similar between arms.","['Patients with locally advanced prostate cancer', 'Eligible patients had a biopsy Gleason score of 4 + 3 = 7 or greater, prostate-specific antigen (PSA) greater than 20 ng/mL, or T3 disease (by prostate magnetic resonance imaging', 'men with locally advanced prostate cancer', 'Seventy-five patients were enrolled at four centers', 'Intense Androgen Deprivation Before Prostatectomy']","['ELAP or EL', 'Enzalutamide and Leuprolide With or Without Abiraterone', 'neoadjuvant enzalutamide and leuprolide (EL) with or without abiraterone and prednisone (ELAP) before radical prostatectomy (RP']","['Tumor ERG positivity and PTEN loss', 'tolerated', 'risk of cancer recurrence and mortality', 'favorable pathologic responses', 'levels of ERG, PTEN, androgen receptor PSA, and glucocorticoid receptor expression', 'Rates of ypT3 disease, positive margins, and positive lymph nodes', 'recurrence rates', 'PSA, surgical staging, positive margins, and safety', 'pathologic complete response or minimal residual disease rate', 'pathologic complete response or minimal residual disease (residual tumor ≤ 5 mm']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid Receptor'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumor'}]",75.0,0.123927,"Rates of ypT3 disease, positive margins, and positive lymph nodes were similar between arms.","[{'ForeName': 'Rana R', 'Initials': 'RR', 'LastName': 'McKay', 'Affiliation': '1 University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': '3 Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Wanling', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': ""2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Rosina', 'Initials': 'R', 'LastName': 'Lis', 'Affiliation': ""2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Calagua', 'Affiliation': '3 Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Quoc-Dien', 'Initials': 'QD', 'LastName': 'Trinh', 'Affiliation': ""2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': ""2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Harshman', 'Affiliation': ""2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': '4 Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Pienta', 'Affiliation': '4 Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Lin', 'Affiliation': '5 University of Washington, Seattle, WA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Ellis', 'Affiliation': '5 University of Washington, Seattle, WA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Montgomery', 'Affiliation': '5 University of Washington, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': '3 Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wagner', 'Affiliation': '3 Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Bubley', 'Affiliation': '3 Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': ""2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': ""2 Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01777']
1533,30858012,Cardiometabolic Adverse Effects and Its Predictors in Children and Adolescents With First-Episode Psychosis During Treatment With Quetiapine-Extended Release Versus Aripiprazole: 12-Week Results From the Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA) Trial.,"OBJECTIVE
To investigate cardiometabolic effects and their predictors in youths with first-episode psychosis (FEP) treated with quetiapine-extended release (ER) versus aripiprazole.
METHOD
Youths with FEP who were 12 to 17 years of age were randomized to quetiapine-ER or aripiprazole in the 12-week, double-blinded, Tolerability and Efficacy of Antipsychotics (TEA) trial. Primary outcome was change in body weight; secondary outcomes were changes in body mass index (BMI) and waist circumference (WC), blood pressure (BP), heart rate, and lipid and glucose metabolism parameters. Possible predictors of cardiometabolic changes were examined.
RESULTS
Altogether, 113 patients (schizophrenia-spectrum disorders = 93%; age [mean ± SD] = 15.7 ± 1.4 years; male participants = 30.1%) were randomized to quetiapine-ER (n = 55) or aripiprazole (n = 58). Quetiapine-ER led to significant increases in body weight (4.88 kg, 95% CI = 3.92-5.83, p < .0001), BMI z-score (0.43, 95% CI = 0.33-0.53, p < .0001), and WC z-score (0.97, CI = 0.7-1.23, p < .0001). Changes were significantly smaller with aripiprazole (all between-group p values <.0001): body weight: 1.97 kg (CI = 0.97-2.97, p = .0001), BMI z-score: 0.10 (CI = -0.01 to 0.20, p = .0646), and WC z-score: 0.18 (CI = -0.09 to 0.45, p = .1968). Lipid and glucose metabolism parameters increased significantly at week 4 and week 12 only with quetiapine-ER (p range = 0.0001-0.037). Quetiapine-ER was associated with an increased occurrence of obesity, elevated blood lipids and hyperinsulinemia (p range = 0.004-0.039). Early weight gain, obesity, or type 2 diabetes in the family significantly predicted weight and BMI gain at week 12.
CONCLUSION
In youths with FEP, quetiapine-ER was associated with significantly greater weight gain and adverse changes in metabolic outcomes than was aripiprazole. Early weight gain must be addressed and family lifestyle factors taken into consideration when treating youths with antipsychotics.
CLINICAL TRIAL REGISTRATION INFORMATION
Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA); https://clinicaltrials.gov; NCT01119014.",2019,Lipid and glucose metabolism parameters increased significantly at week 4 and week 12 only with quetiapine-ER (p range = 0.0001-0.037).,"['113 patients (schizophrenia-spectrum disorders\xa0= 93%; age [mean ± SD]\xa0= 15.7 ± 1.4 years; male participants\xa0= 30.1', 'Children and Adolescents With Psychosis (TEA', 'Youths with FEP who were 12 to 17 years of age', 'Children and Adolescents With First-Episode Psychosis During Treatment With', 'youths with first-episode psychosis (FEP) treated with', 'Children and Adolescents With Psychosis (TEA) Trial']","['quetiapine-extended release (ER) versus aripiprazole', 'Antipsychotics (TEA', 'quetiapine-ER', 'quetiapine-ER or aripiprazole', 'Quetiapine-ER', 'Quetiapine-Extended Release Versus Aripiprazole', 'aripiprazole', 'Antipsychotics']","['Early weight gain, obesity, or type 2 diabetes', 'weight gain and adverse changes in metabolic outcomes', 'weight and BMI gain', 'BMI z-score', 'change in body weight; secondary outcomes were changes in body mass index (BMI) and waist circumference (WC), blood pressure (BP), heart rate, and lipid and glucose metabolism parameters', 'WC z-score', 'Lipid and glucose metabolism parameters', 'occurrence of obesity, elevated blood lipids and hyperinsulinemia', 'body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}]",113.0,0.121064,Lipid and glucose metabolism parameters increased significantly at week 4 and week 12 only with quetiapine-ER (p range = 0.0001-0.037).,"[{'ForeName': 'Karsten Gjessing', 'Initials': 'KG', 'LastName': 'Jensen', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. Electronic address: karsten.gjessing.jensen@regionh.dk.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Hofstra Northwell School of Medicine and The Zucker Hillside Hospital, New York, NY, and the Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Ditte', 'Initials': 'D', 'LastName': 'Rudå', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Dea Gowers', 'Initials': 'DG', 'LastName': 'Klauber', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Marie Stentebjerg', 'Initials': 'MS', 'LastName': 'Decara', 'Affiliation': 'Psychiatric Centre Copenhagen, Capital Region of Denmark, Copenhagen, Denmark, and the Laboratory of Neuropsychiatry, University of Copenhagen, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Fagerlund', 'Affiliation': 'Lundbeck Foundation Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), and Center for Neuropsychiatric Schizophrenia Research (CNSR), Copenhagen University Hospital, Mental Health Services, Capital Region of Denmark.'}, {'ForeName': 'Jens Richardt Møllegaard', 'Initials': 'JRM', 'LastName': 'Jepsen', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Lundbeck Foundation Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), and Center for Neuropsychiatric Schizophrenia Research (CNSR), Copenhagen University Hospital, Mental Health Services, Capital Region of Denmark.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Eriksson', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Fink-Jensen', 'Affiliation': 'Psychiatric Centre Copenhagen, Capital Region of Denmark, Copenhagen, Denmark, and the Laboratory of Neuropsychiatry, University of Copenhagen, Denmark.'}, {'ForeName': 'Anne Katrine', 'Initials': 'AK', 'LastName': 'Pagsberg', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.01.015']
1534,30429730,Using propranolol in traumatic brain injury to reduce sympathetic storm phenomenon: A prospective randomized clinical trial.,"Background
Traumatic brain injury (TBI) correlated with increased sympathetic activity on the expense of parasympathetic system due to loss of cortical control after brain injury. Manifestations of sympathetic storm include tachycardia, hypertension, tachypnea, and hyperthermia. The neuroprotective effects via reducing cerebral metabolism and lowering O 2 and glucose consumption are the targets early after trauma. Beta-blockers reduce sympathetic activity.
Objectives
We suppose that using propranolol blunts the sympathetic storming phenomenon as it is a nonselective β inhibitor and has a lipophilic property to steadily penetrate blood-brain barrier.
Patients and Methods
Sixty patients allocated randomly into two groups, each consisting of 30 patients. Group A started propranolol and Group B received placebo within first 24 h. Primary outcome was catecholamine levels on day 7, and the secondary outcomes were physiological measures (heart rate [HR], respiratory rate [RR], mean arterial blood pressure [MABP], temperature, random blood sugar, and follow-up Glasgow coma score [GCS] and sedation score).
Results
Analysis of outcomes demonstrated that Group A tended to have lower catecholamine levels in comparison to Group B in day 7 (norepinephrine 206.87 ± 44.44 vs. 529.33 ± 42.99 pg/ml, P = <0.001), epinephrine level (69.00 ± 8.66 vs. 190.73 ± 16.48 pg/ml, P < 0.001), and dopamine level (32.90 ± 4.57 vs. 78.00 ± 3.48 pg/ml P < 0.001). GCS of the patients in Group A improved and was statistically significant compared to Group B in day 7 (13 vs. 10, P = 0.006), with percent change interquartile range (20.0 vs. 8.33, P = 0.006). Regarding hemodynamic parameters between the two groups MABP, HR, RR, and temperature, there was no statistically significant difference on day 1, while on day 7, there is high statistical significance and significant percent change ( P < 0.001).
Conclusion
Early usage of propranolol after TBI controls hemodynamics and blood sugar with decreased catecholamine levels correlated with the improvement of GCS.",2018,"Regarding hemodynamic parameters between the two groups MABP, HR, RR, and temperature, there was no statistically significant difference on day 1, while on day 7, there is high statistical significance and significant percent change ( P < 0.001).
",[],"['propranolol', 'placebo']","['catecholamine levels', 'cerebral metabolism and lowering O 2 and glucose consumption', 'physiological measures (heart rate [HR], respiratory rate [RR], mean arterial blood pressure [MABP], temperature, random blood sugar, and follow-up Glasgow coma score [GCS] and sedation score', 'MABP, HR, RR, and temperature', 'epinephrine level', 'dopamine level', 'tachycardia, hypertension, tachypnea, and hyperthermia']",[],"[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0546632', 'cui_str': 'Catecholamine measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score finding'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0201998', 'cui_str': 'Adrenaline measurement'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",60.0,0.107122,"Regarding hemodynamic parameters between the two groups MABP, HR, RR, and temperature, there was no statistically significant difference on day 1, while on day 7, there is high statistical significance and significant percent change ( P < 0.001).
","[{'ForeName': 'Mona Ahmed', 'Initials': 'MA', 'LastName': 'Ammar', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Noha Sayed', 'Initials': 'NS', 'LastName': 'Hussein', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_33_18']
1535,30429735,"Comparative evaluation of analgesic sparing efficacy between dexmedetomidine and clonidine used as adjuvant to ropivacaine in thoracic paravertebral block for patients undergoing breast cancer surgery: A prospective, randomized, double-blind study.","Introduction
Thoracic paravertebral block (TPVB) is an effective method for intra- and post-operative pain management in thoracic surgeries. For a long time, various adjuvants have been tried for prolonging the duration of TPVB.
Objective
In this prospective study, we have compared the analgesic sparing efficacy of dexmedetomidine and clonidine, two α 2 adrenergic agonists, administered along with ropivacaine for TPVB for breast cancer surgery patients.
Materials and Methods
Forty-four breast cancer surgery patients undergoing general anesthesia (GA) were randomly divided into Group C and Group D ( n = 44 each) receiving preoperative TPVB at T 3-5 level with 0.5% ropivacaine solution admixture with clonidine and dexmedetomidine, respectively. Cancer surgery was performed under GA. Intraoperative fentanyl and propofol requirement was compared. Visual analogue scale was used for pain assessment. Total dose and mean time to administration of first rescue analgesic diclofenac sodium was noted. Side effects and hemodynamic parameters were also noted.
Results
Intraoperative fentanyl and propofol requirement was significantly less in dexmedetomidine group than clonidine. The requirement of diclofenac sodium was also significantly less and later in Group D than Group C. Hemodynamics, and side effects were comparable among two groups.
Conclusion
Dexmedetomidine provided better intraoperative as well as postoperative analgesia than clonidine when administered with ropivacaine in TPVB before breast cancer surgery patients without producing remarkable side effects.",2018,"The requirement of diclofenac sodium was also significantly less and later in Group D than Group C. Hemodynamics, and side effects were comparable among two groups.
","['patients undergoing breast cancer surgery', 'Materials and Methods\n\n\nForty-four breast cancer surgery patients undergoing general anesthesia (GA', 'TPVB before breast cancer surgery patients', 'breast cancer surgery patients']","['ropivacaine solution admixture with clonidine and dexmedetomidine', 'Dexmedetomidine', 'Intraoperative fentanyl and propofol', 'diclofenac sodium', 'dexmedetomidine and clonidine', 'clonidine', 'ropivacaine', 'dexmedetomidine', 'Introduction\n\n\nThoracic paravertebral block (TPVB']","['Visual analogue scale', 'Total dose and mean time to administration of first rescue analgesic diclofenac sodium', 'side effects', 'Side effects and hemodynamic parameters', 'postoperative analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",44.0,0.0466257,"The requirement of diclofenac sodium was also significantly less and later in Group D than Group C. Hemodynamics, and side effects were comparable among two groups.
","[{'ForeName': 'Anindya', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Nairita', 'Initials': 'N', 'LastName': 'Mayur', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Chiranjib', 'Initials': 'C', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Anaesthesiology, IPGMER, Kolkata, West Bengal, India.'}, {'ForeName': 'Hirak', 'Initials': 'H', 'LastName': 'Biswas', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapobrata', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Roybasunia', 'Affiliation': 'Department of Anaesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'Subrata Kumar', 'Initials': 'SK', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_81_18']
1536,31655422,"Aquatic exercise and Far Infrared (FIR) modulates pain and blood cytokines in fibromyalgia patients: A double-blind, randomized, placebo-controlled pilot study.","Fibromyalgia (FM) has an inflammatory component, as elevated serum levels of inflammatory biomarkers are associated with its diagnosis. Treatments decreased pain, body temperature, improved quality of life and reduced serum levels of IL-6 in both groups; however, these beneficial effects were more pronounced in aquatic exercise (AE) + Far-Infrared (FIR) group. The findings of the present study suggest that the association of AE to FIR increases the benefits of aquatic exercise in patients with FM.",2019,"Treatments decreased pain, body temperature, improved quality of life and reduced serum levels of IL-6 in both groups; however, these beneficial effects were more pronounced in aquatic exercise (AE) + Far-Infrared (FIR) group.","['fibromyalgia patients', 'patients with FM']","['Aquatic exercise and Far Infrared (FIR', 'placebo']","['aquatic exercise (AE)\u202f+\u202fFar-Infrared (FIR', 'pain, body temperature, improved quality of life and reduced serum levels of IL-6']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0330195', 'cui_str': 'Fir Tree'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0330195', 'cui_str': 'Fir Tree'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.295474,"Treatments decreased pain, body temperature, improved quality of life and reduced serum levels of IL-6 in both groups; however, these beneficial effects were more pronounced in aquatic exercise (AE) + Far-Infrared (FIR) group.","[{'ForeName': 'Daiana Cristina', 'Initials': 'DC', 'LastName': 'Salm', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Luiz Augusto Oliveira', 'Initials': 'LAO', 'LastName': 'Belmonte', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Aline Armiliato', 'Initials': 'AA', 'LastName': 'Emer', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Larissa Dos Santos', 'Initials': 'LDS', 'LastName': 'Leonel', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Rômulo Nolasco', 'Initials': 'RN', 'LastName': 'de Brito', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Cinthia Calheiros', 'Initials': 'CC', 'LastName': 'da Rocha', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Thiago César', 'Initials': 'TC', 'LastName': 'Martins', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Diogo Cunha', 'Initials': 'DC', 'LastName': 'Dos Reis', 'Affiliation': 'Technological Center and Biomechanics Laboratory, CDS, Federal University of Santa Catarina, Florianópolis 88040-370, Santa Catarina, Brazil.'}, {'ForeName': 'Antônio Renato Pereira', 'Initials': 'ARP', 'LastName': 'Moro', 'Affiliation': 'Technological Center and Biomechanics Laboratory, CDS, Federal University of Santa Catarina, Florianópolis 88040-370, Santa Catarina, Brazil.'}, {'ForeName': 'Leidiane', 'Initials': 'L', 'LastName': 'Mazzardo-Martins', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Neuroscience, Center of Biological Sciences, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Maicon Roberto', 'Initials': 'MR', 'LastName': 'Kviecinski', 'Affiliation': 'Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Franciane', 'Initials': 'F', 'LastName': 'Bobinski', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Afonso Shiguemi Inoue', 'Initials': 'ASI', 'LastName': 'Salgado', 'Affiliation': 'Integrative Physical Therapy Residency Program, Philadelphia University Center, Londrina, Paraná, Brazil.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Cidral-Filho', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Daniel Fernandes', 'Initials': 'DF', 'LastName': 'Martins', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx), University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Postgraduate Program in Health Sciences, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil. Electronic address: daniel.martins4@unisul.br.'}]",Journal of neuroimmunology,['10.1016/j.jneuroim.2019.577077']
1537,30872116,"Loss of bronchoprotection with ICS plus LABA treatment, β-receptor dynamics, and the effect of alendronate.","BACKGROUND
Loss of bronchoprotection (LOBP) with a regularly used long-acting β 2 -adrenergic receptor agonist (LABA) is well documented. LOBP has been attributed to β 2 -adrenergic receptor (B2AR) downregulation, a process requiring farnesylation, which is inhibited by alendronate.
OBJECTIVE
We sought to determine whether alendronate can reduce LABA-associated LOBP in inhaled corticosteroid (ICS)-treated patients.
METHODS
We conducted a randomized, double-blind, placebo-controlled, parallel-design, proof-of-concept trial. Seventy-eight participants with persistent asthma receiving 250 μg of fluticasone twice daily for 2 weeks were randomized to receive alendronate or placebo while initiating salmeterol for 8 weeks. Salmeterol-protected methacholine challenges (SPMChs) and PBMC B2AR numbers (radioligand binding assay) and signaling (cyclic AMP ELISA) were assessed before randomization and after 8 weeks of ICS plus LABA treatment. LOBP was defined as a more than 1 doubling dose reduction in SPMCh PC 20 value.
RESULTS
The mean doubling dose reduction in SPMCh PC 20 value was 0.50 and 0.27 with alendronate and placebo, respectively (P = .62). Thirty-eight percent of participants receiving alendronate and 33% receiving placebo had LOBP (P = .81). The after/before ICS plus LABA treatment ratio of B2AR number was 1.0 for alendronate (P = .86) and 0.8 for placebo (P = .15; P = .31 for difference between treatments). The B2AR signaling ratio was 0.89 for alendronate (P = .43) and 1.02 for placebo (P = .84; P = .44 for difference). Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
CONCLUSION
This study did not find evidence that alendronate reduces LABA-associated LOBP, which relates to the occurrence of LOBP in only one third of participants. LOBP appears to be less common than presumed in concomitant ICS plus LABA-treated asthmatic patients. B2AR downregulation measured in PBMCs does not appear to reflect LOBP.",2019,"Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
","['Seventy-eight participants with persistent asthma receiving 250\xa0μg of', 'twice daily for 2\xa0weeks', 'inhaled corticosteroid (ICS)-treated patients']","['salmeterol', 'placebo', 'fluticasone', 'alendronate or placebo', 'LOBP', 'Salmeterol-protected methacholine', 'alendronate']","['PBMC B2AR numbers (radioligand binding assay) and signaling (cyclic AMP', 'B2AR number', 'ELISA', 'B2AR downregulation measured in PBMCs', 'lung function and B2AR number and signaling', 'B2AR signaling ratio', 'LOBP']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}]","[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0013081', 'cui_str': 'Down-Regulation (Physiology)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",78.0,0.67113,"Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
","[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Departments of Environmental Health, Genetics & Complex Diseases, Harvard T.H. Chan School of Public Health, Boston, Mass.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Departments of Environmental Health, Genetics & Complex Diseases, Harvard T.H. Chan School of Public Health, Boston, Mass.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Gerard', 'Affiliation': ""Department of Pediatrics, Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'McIntire', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Homer A', 'Initials': 'HA', 'LastName': 'Boushey', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Mo.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Codispoti', 'Affiliation': 'Department of Medicine, Rush University Medical Center and Department of Pediatrics, Stroger Hospital of Cook County, Chicago, Ill.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dyer', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'Department of Medicine, Pittsburgh University, Pittsburgh, Pa.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'Department of Medicine, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lazarus', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Lemanske', 'Affiliation': 'Departments of Medicine and Pharmacy Practice, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Njira', 'Initials': 'N', 'LastName': 'Lugogo', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Mauger', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moy', 'Affiliation': 'Department of Medicine, Rush University Medical Center and Department of Pediatrics, Stroger Hospital of Cook County, Chicago, Ill.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Ortega', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Solway', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Ill.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': 'Departments of Medicine and Pharmacy Practice, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Kaharu', 'Initials': 'K', 'LastName': 'Sumino', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Mo.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish University, Denver, Colo.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wenzel', 'Affiliation': 'Department of Medicine, Pittsburgh University, Pittsburgh, Pa.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass. Electronic address: eisrael@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.01.049']
1538,32408038,Does eccentric-concentric resistance training improve early functional outcomes compared to concentric resistance training after total knee arthroplasty?,"BACKGROUND
Total knee arthroplasty (TKA) is the preferred surgical treatment of end stage osteoarthritis of the knee. However, up to 20% of patients are dissatisfied after TKA. Moreover, kinesiophobia is negatively correlated with functional outcomes.
RESEARCH QUESTION
The aim of this study was to compare the effects of combined concentric-eccentric versus concentric program on muscular strength assessment and quality of life, after total knee arthroplasty in elderly people.
METHOD
A prospective study including 20 subjects (72.1 ± 6.3 years), following a rehabilitation program after TKA was performed. Subjects were randomized in combined eccentricconcentric (ECC-CON, n = 10) versus concentric (CN, n = 10) early rehabilitation protocols. There were no significant differences between groups with respect to demographic data. Data were collected before and after protocol: performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life (Lequesne-ISK, WOMAC, OAKHQOL) and kinesiophobia assessment (TSK-CF). The Gaussian distribution for the whole population of this study was tested by a Kolmogorov-Smirnov test. Statistical analysis was performed using non-parametric Mann-Whitney U or Fisher's exact probability test, as appropriate.
RESULTS AND CONCLUSION
Performance-based physical function tests showed a significant improvement after early rehabilitation in the ECC-CON group for timed up and go (p = 0.0002) and 10-meter walk test (p = 0.001). Operated hamstring muscle peak torque was significantly improved in the ECC-CON group (p = 0.03). Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04). Self-reported kinesiophobia significantly decreased after rehabilitation in both groups (p = 0.01) whilst there were no differences between groups. Early combined eccentric-concentric rehabilitation after TKA appears to be associated with improved outcomes compared to classic concentric rehabilitation protocols, on both physical function and quality of life. This information is new. Assessment and care of kinesiophobia should be considered in rehabilitation protocols standards.",2020,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"['elderly people', '20 subjects (72.1\u202f±\u202f6.3 years), following a rehabilitation program after TKA was performed']","['combined concentric-eccentric versus concentric program', 'Total knee arthroplasty (TKA', 'concentric resistance training', 'eccentric-concentric resistance training', 'combined eccentricconcentric (ECC-CON, n\u202f=\u202f10) versus concentric (CN, n\u202f=\u202f10) early rehabilitation protocols', 'ECC-CON']","['Self-reported kinesiophobia', 'physical function and quality of life', 'Operated hamstring muscle peak torque', 'performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life ', 'muscular strength assessment and quality of life', 'Self-reported physical function and quality of life tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",20.0,0.023474,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Teissier', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Department of Orthopaedic Surgery, Hospital Cochin, APHP, Université Paris 5, Paris, France. Electronic address: vic.teissier@gmail.com.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Leclercq', 'Affiliation': ""Université d'Orléans, COST, 45100, Orléans, France. Electronic address: apa.olivet@orpea.net.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Schiano-Lomoriello', 'Affiliation': 'Université Orléans, CIAMS, 45067, Orléans, France; CIAMS, Université Paris-Sud, Université Paris-Saclay, 91405, Orsay Cedex, France. Electronic address: sandrine.schiano-lomoriello@univ-orleans.fr.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Nizard', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; 6-AP-HP, Hôpital Lariboisière, Service de chirurgie orthopédique, F-75010, Paris, France. Electronic address: remy.nizard@aphp.fr.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Portier', 'Affiliation': ""Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Université d'Orléans, COST, 45100, Orléans, France. Electronic address: hugues.portier@univ-orleans.fr.""}]",Gait & posture,['10.1016/j.gaitpost.2020.04.020']
1539,30659676,Double transcranial direct current stimulation of the brain increases cerebral energy levels and systemic glucose tolerance in men.,"Transcranial direct current stimulation (tDCS) is a neuromodulatory method that has been tested experimentally and has already been used as an adjuvant therapeutic option to treat a number of neurological disorders and neuropsychiatric diseases. Beyond its well known local effects within the brain, tDCS also transiently promotes systemic glucose uptake and reduces the activity of the neurohormonal stress axes. We aimed to test whether the effects of a single tDCS application could be replicated upon double stimulation to persistently improve systemic glucose tolerance and stress axes activity in humans. In a single-blinded cross-over study, we examined 15 healthy male volunteers. Anodal tDCS vs sham was applied twice in series. Systemic glucose tolerance was investigated by the standard hyperinsulinaemic-euglycaemic glucose clamp procedure, and parameters of neurohormonal stress axes activity were measured. Because tDCS-induced brain energy consumption has been shown to be part of the mechanism underlying the assumed effects, we monitored the cerebral high-energy phosphates ATP and phosphocreatine by 31 phosphorus magnetic resonance spectroscopy. As hypothesised, analyses revealed that double anodal tDCS persistently increases glucose tolerance compared to sham. Moreover, we observed a significant rise in cerebral high-energy phosphate content upon double tDCS. Accordingly, the activity of the neurohormonal stress axes was reduced upon tDCS compared to sham. Our data demonstrate that double tDCS promotes systemic glucose uptake and reduces stress axes activity in healthy humans. These effects suggest that repetitive tDCS may be a future non-pharmacological option for combating glucose intolerance in type 2 diabetes patients.",2019,"Accordingly, the activity of the neurohormonal stress axes was reduced upon tDCS compared to sham.","['healthy humans', 'humans', '15 healthy male volunteers', 'type 2 diabetes patients', 'men']","['Anodal tDCS', 'Transcranial direct current stimulation (tDCS', 'repetitive tDCS']","['glucose tolerance', 'cerebral high-energy phosphate content', 'Systemic glucose tolerance', 'systemic glucose tolerance and stress axes activity', 'standard hyperinsulinaemic-euglycaemic glucose clamp procedure, and parameters of neurohormonal stress axes activity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015159', 'cui_str': 'Glucose Clamping'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",31.0,0.11243,"Accordingly, the activity of the neurohormonal stress axes was reduced upon tDCS compared to sham.","[{'ForeName': 'Ewelina K', 'Initials': 'EK', 'LastName': 'Wardzinski', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Friedrichsen', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Dannenberger', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Kistenmacher', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Uwe H', 'Initials': 'UH', 'LastName': 'Melchert', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Jauch-Chara', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}]",Journal of neuroendocrinology,['10.1111/jne.12688']
1540,30415813,The Risk of Sexual Dysfunction and Effectiveness of Treatment of Benign Prostatic Hyperplasia With Severe Lower Urinary Tract Dysfunction With Combination of Dutasteride and Solifenacin.,"INTRODUCTION
Correction of benign prostatic hyperplasia (BPH) with lower urinary tract (LUT) symptoms (LUTS) is treated with drugs of different pharmacological classes having side effects including suppression of sexual function.
AIM
To assess the effect of simultaneous intake of dutasteride and solifenacin on the reversibility of severe LUTS and sexual function in men with BPH.
METHODS
Patients from group A took dutasteride 0.5 mg/d, those from group В took dutasteride 0.5 mg/d and solifenacin 10 mg/d, and those from group С took dutasteride 0.5 mg/d and solifenacin 20 mg/d. The duration of the observation was 6 months. The sexual function was rated with the International Index of Erectile Function questionnaire and Men's Sexual Health Questionnaire-ejaculatory dysfunction. The functional status of LUT was rated with International Prostate Symptom Score, overactive bladder questionnaire-awareness tool, diary voiding, and uroflowmetry.
MAIN OUTCOME MEASURE
The state of sexual function and function of the LUT in men improved.
RESULTS
The erectile function in all men, having participated in the study, did not change [group A, 9.8 (1.6)/9.4 (3.8), P ≥ .05; group B, 10.1 (2.1)/10.5 (3.7), P ≥ .05; group C, 9.7 (1.5)/9.5 (2.6), P ≥ .05]. The ejaculator function significantly decreased in all groups. According to International Prostate Symptom Score, obstruction diminished in this group [incomplete emptying, 3.7 (0.7)/1.5 (0.3), P ≤ .05; intermittence, 3.5 (1.0)/3.5 (1.0), P ≤ .05; weak stream, 3.8 (0.6)/1.5 (0.4), P ≤ .05; straining, 3.4 (0.5)/0.7 (0.7), P ≤ .05] as did hyperactivity [urgency, 2.8 (0.7)/0.9 (0.7), P ≤ .05; nocturia, 2.8 (0.6)/1.2 (0.4), P ≤ .05]. All numbers in the manuscript are given in points unless otherwise stated. The values in parentheses are SD (unless otherwise specified).
CLINICAL IMPLICATIONS
The information that a high dose of solifenacin administered concomitantly with dutasteride may contribute to increase in sexual satisfaction and preservation of erectile function at the baseline level can be useful and used by sexologists, urologists, and family doctors.
STRENGTH & LIMITATIONS
The combination of dutasteride 0.5 mg/d and solifenacin 10 mg/d saves erectile function and improves sexual satisfaction. At the same time, the symptoms of obstruction and hyperactivity disappear or are reduced in most patients. Nevertheless, we did not study late results of the combined therapy.
CONCLUSION
Suggested combination does not impact on erectile function but decreases ejaculator function; however, it does not affect a general high rating of sexual function by patients. Thus, overall sexual function in men with BPH and severe LUTS is not impaired by prolonged intake of double dosage of solifenacin combined with dutasteride. The combination of dutasteride and solifenacin is effective and safe to treat BPH and severe LUTS. Kosilov K, Kuzina I, Kuznetsov V, et al. The Risk of Sexual Dysfunction and Effectiveness of Treatment of Benign Prostatic Hyperplasia With Severe Lower Urinary Tract Dysfunction With Combination of Dutasteride and Solifenacin. J Sex Med 2018;15:1579-1590.",2018,"According to International Prostate Symptom Score, obstruction diminished in this group [incomplete emptying, 3.7 (0.7)/1.5 (0.3), P ≤ .05; intermittence, 3.5 (1.0)/3.5 (1.0), P ≤ .05; weak stream, 3.8 (0.6)/1.5 (0.4), P ≤ .05; straining, 3.4 (0.5)/0.7 (0.7), P ≤ .05] as did hyperactivity [urgency, 2.8 (0.7)/0.9 (0.7), P ≤ .05; nocturia, 2.8 (0.6)/1.2 (0.4), P ≤ .05].","['men with BPH and severe LUTS', 'men with BPH', 'Benign Prostatic Hyperplasia', 'Patients from group A took']","['dutasteride and solifenacin', 'dutasteride 0.5 mg/d and solifenacin 20 mg/d', 'dutasteride', 'dutasteride 0.5 mg/d and solifenacin', 'solifenacin', 'solifenacin combined with dutasteride', 'Dutasteride and Solifenacin']","['symptoms of obstruction and hyperactivity disappear', 'sexual satisfaction', 'sexual satisfaction and preservation of erectile function', 'erectile function', 'International Prostate Symptom Score, overactive bladder questionnaire-awareness tool, diary voiding, and uroflowmetry', 'ejaculator function', ""International Index of Erectile Function questionnaire and Men's Sexual Health Questionnaire-ejaculatory dysfunction"", 'overall sexual function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C1593561', 'cui_str': 'Dutasteride 0.5 MG [Avodart]'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry (procedure)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",,0.0243811,"According to International Prostate Symptom Score, obstruction diminished in this group [incomplete emptying, 3.7 (0.7)/1.5 (0.3), P ≤ .05; intermittence, 3.5 (1.0)/3.5 (1.0), P ≤ .05; weak stream, 3.8 (0.6)/1.5 (0.4), P ≤ .05; straining, 3.4 (0.5)/0.7 (0.7), P ≤ .05] as did hyperactivity [urgency, 2.8 (0.7)/0.9 (0.7), P ≤ .05; nocturia, 2.8 (0.6)/1.2 (0.4), P ≤ .05].","[{'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Kosilov', 'Affiliation': 'Department of Social Sciences, School of Humanities, Far Eastern Federal University, Vladivostok, Russia; Department of Fundamental Medicine, School of Biomedicine, Far Eastern Federal University, Vladivostok, Russia; Department Public Health, Pacific Ocean State Medical University, Vladivostok, Russia. Electronic address: oton2000@mail.ru.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Kuzina', 'Affiliation': 'Department of Social Sciences, School of Humanities, Far Eastern Federal University, Vladivostok, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kuznetsov', 'Affiliation': 'Department Public Health, Pacific Ocean State Medical University, Vladivostok, Russia.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Gainullina', 'Affiliation': 'Department of Social Sciences, School of Humanities, Far Eastern Federal University, Vladivostok, Russia.'}, {'ForeName': 'Liliya', 'Initials': 'L', 'LastName': 'Kosilova', 'Affiliation': 'Department of Functional Diagnostics, Medical Association No. 2 of Vladivostok City, Vladivostok, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Karashchuk', 'Affiliation': 'Department Public Health, Pacific Ocean State Medical University, Vladivostok, Russia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prokofyeva', 'Affiliation': 'Department of Social Sciences, School of Humanities, Far Eastern Federal University, Vladivostok, Russia.'}, {'ForeName': 'Sergay', 'Initials': 'S', 'LastName': 'Loparev', 'Affiliation': 'Polyclinic 3, Department of Urology, Vladivostok, Russia.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2018.09.011']
1541,30429737,Evaluation of thoracolumbar interfascial plane block for postoperative analgesia after herniated lumbar disc surgery: A randomized clinical trial.,"Background
Thoracolumbar interfascial plane (TLIP) block involves injection of local anesthetics between multifidus and longissimus muscles at the 3 rd lumbar vertebral level assuming that it can block the dorsal rami of thoracolumbar nerves.
Objective
The objective of this study was to evaluate the analgesic effects gained after performing TLIP block (analogous to the transversus abdominis plane [TAP] block, but intended for the back) in patients undergoing lumbar discectomy.
Methodology
This was a prospective, randomized, double-blinded, controlled clinical trial. Computer-generated randomization numbers were used to allocate patients into two groups. A total of 102 patients scheduled for lumbar discectomy were considered eligible, of these 70 patients were randomly included in the analysis: 35 patients (control group) received the standard general anesthetic technique and 35 patients (TLIP group) received TLIP block with 20 ml mixture of 0.25% bupivacaine and 1% lidocaine on each side. The primary outcome was to compare the two groups with regard to pain scores, whereas the secondary outcomes included the time to first analgesic (TFA), 24-h morphine consumption, and side effects associated with morphine such as nausea, vomiting, and sedation.
Results
TLIP group compared with the control group showed a significant reduction in the postoperative Visual Analog Scale for pain score both on rest and movement, with no statistically significant difference at 24 h during movement. TFA was significantly shorter in the control group compared to the TLIP group (82.00 ± 69.01 vs. 442.7 ± 126.47 min, P < 0.001). TLIP group had lower cumulative morphine consumption than control group of statistically significant difference (9.7 ± 6.38 vs. 25.88 ± 5.17 mg, P < 0.001). TLIP block group compared with the control group showed a significant reduction of nausea and a lower incidence of sedation.
Conclusion
TLIP block is an effective and safe method for postoperative analgesia after lumbar discectomy.",2018,"Results
TLIP group compared with the control group showed a significant reduction in the postoperative Visual Analog Scale for pain score both on rest and movement, with no statistically significant difference at 24 h during movement.","['postoperative analgesia after herniated lumbar disc surgery', 'patients undergoing lumbar discectomy', '102 patients scheduled for lumbar discectomy were considered eligible, of these 70 patients were randomly included in the analysis: 35 patients (control group) received the']","['standard general anesthetic technique and 35 patients (TLIP group) received TLIP block with 20 ml mixture of 0.25% bupivacaine and 1% lidocaine', 'thoracolumbar interfascial plane block', 'TLIP block', 'TLIP']","['analgesic effects', 'TFA', 'time to first analgesic (TFA), 24-h morphine consumption, and side effects associated with morphine such as nausea, vomiting, and sedation', 'postoperative Visual Analog Scale for pain score', 'pain scores', 'cumulative morphine consumption', 'nausea']","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0017302', 'cui_str': 'Anesthetics, General'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",102.0,0.162802,"Results
TLIP group compared with the control group showed a significant reduction in the postoperative Visual Analog Scale for pain score both on rest and movement, with no statistically significant difference at 24 h during movement.","[{'ForeName': 'Mona Ahmed', 'Initials': 'MA', 'LastName': 'Ammar', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Taeimah', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_177_18']
1542,30429743,A comparative study between interlaminar nerve root targeted epidural versus infraneural transforaminal epidural steroids for treatment of intervertebral disc herniation.,"Background
Low back pain (LBP) is one of the most common musculoskeletal abnormalities. Epidural corticosteroid injections (ESIs) have been used long time ago for treatment of lumbar radiculopathy or discogenic back pain in case of failed medical and conservative management. Different techniques for ESIs include the interlaminar, the caudal, and the transforaminal approaches.
Purpose
The aim of our study is to compare between the efficacy of infraneural transforaminal ESI and lumbar paramedian nerve root targeted interlaminar steroid injection in reduction of unilateral radicular pain secondary to disc prolapse.
Patients and Methods
This prospective double-blind randomized study was performed on 40 patients randomized into two equal groups, each of 20: the infraneural transforaminal ESI (IN group) and the interlaminar parasagittal ESI (IL group). Patients with backache without leg radiation, or with focal motor neurological deficit, previous spine surgery, S1 radiculopathy, lumbar ESI in the past month, systemic steroid used recently within 4 weeks before the procedure, allergy to any medication or addiction to opioids, and pregnancy were excluded from the study. The duration and efficacy of pain relief (defined as ≥40% reduction of pain perception) by 0-10 visual analog scale (VAS) is the primary outcome. Functional assessment using Modified Oswestry Disability Questionnaire (MODQ) and possible side effects and complications are the secondary outcomes.
Results
The VAS and MODQ scores were significantly lower in both groups in comparison with the basal values. There was also a lower VAS in the infraneural group than the parasagittal (IL) group up to 6 months after injection.
Conclusion
The infraneural (IN) epidural steroid is more favorable than the parasagittal (IL) interlaminar epidural steroid owing to its long-term improvement in physical function than the parasagittal technique with no serious side effects.",2018,The VAS and MODQ scores were significantly lower in both groups in comparison with the basal values.,"['unilateral radicular pain secondary to disc prolapse', 'Patients with backache without leg radiation, or with focal motor neurological deficit, previous spine surgery, S1 radiculopathy, lumbar ESI in the past month, systemic steroid used recently within 4 weeks before the procedure, allergy to any medication or addiction to opioids, and pregnancy were excluded from the study', 'intervertebral disc herniation', '40 patients randomized into two equal groups, each of 20: the']","['infraneural transforaminal ESI (IN group) and the interlaminar parasagittal ESI (IL group', 'Epidural corticosteroid injections (ESIs', 'infraneural transforaminal ESI and lumbar paramedian nerve root targeted interlaminar steroid injection', 'interlaminar nerve root targeted epidural versus infraneural transforaminal epidural steroids']","['pain perception', 'VAS and MODQ scores', 'Functional assessment using Modified Oswestry Disability Questionnaire (MODQ', 'duration and efficacy of pain relief', 'lower VAS']","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain (finding)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242362', 'cui_str': 'Intervertebral disc prolapse (disorder)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0522491', 'cui_str': 'Parasagittal (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",40.0,0.0449918,The VAS and MODQ scores were significantly lower in both groups in comparison with the basal values.,"[{'ForeName': 'Alaa-Eldin Adel El', 'Initials': 'AAE', 'LastName': 'Maadawy', 'Affiliation': 'Department of Anesthesia and Pain Management, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Mazy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed El Mitwalli Mansour El', 'Initials': 'MEMME', 'LastName': 'Adrosy', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ashraf Abdel-Moneim', 'Initials': 'AA', 'LastName': 'El-Mitwalli', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ayman Mohamed Abd El', 'Initials': 'AMAE', 'LastName': 'Naby', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Gomma', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_263_18']
1543,30429742,Surgically-assisted abdominal wall blocks for analgesia after abdominoplasty: A prospective randomized trial.,"Background
Abdominoplasty is a common aesthetic procedure. The transversus abdominis plane block (TAPB) and rectus sheath block (RSB) have proven efficacy as analgesic modality for abdominal surgeries. This study demonstrates post-abdominoplasty analgesic duration consequent to the three surgically infiltrated local anesthetic techniques: bilateral TAPB, bilateral RSB, and subcutaneous infiltration (SCI) of 0.25% bupivacaine.
Methods
In this prospective randomized study, 48 adult patients scheduled for abdominoplasty were randomized into three groups: TAPB group ( n = 16), RSB group ( n = 16), and SCI group ( n = 16) utilizing 40 mL of 0.25% bupivacaine for each block. In both TAPB and RSB groups, the block was performed bilaterally after plication of anterior abdominal wall, while in SCI group, the surgical incisional area was infiltrated before skin closure. Main outcome measures included visual analogue scale (VAS), at rest and during movement; the analgesic duration; and the total required doses of morphine in the first postoperative day.
Results
A statistically significant longer analgesia was recorded in the TABP group compared with both the RSB and SCI groups. Statistically significant higher VAS scores in the SCI group 4 hours postoperatively was recorded, both at rest and during movement, compared with both TABP and RSB groups. Significant higher morphine consumption in the SCI group was compared with the other two groups.
Conclusions
Among the surgically infiltrated anesthetic techniques for abdominoplasty, bilateral TAPB was associated with longer postoperatively analgesic duration with lower morphine consumption in the first 24 hours compared with RSB and SCI.",2018,"Statistically significant higher VAS scores in the SCI group 4 hours postoperatively was recorded, both at rest and during movement, compared with both TABP and RSB groups.",['48 adult patients scheduled for abdominoplasty'],"['bupivacaine', 'SCI group ( n = 16) utilizing 40 mL of 0.25% bupivacaine', 'Surgically-assisted abdominal wall blocks', 'transversus abdominis plane block (TAPB) and rectus sheath block (RSB', 'TAPB', 'TABP', 'RSB']","['visual analogue scale (VAS), at rest and during movement; the analgesic duration; and the total required doses of morphine in the first postoperative day', 'surgical incisional area', 'morphine consumption', 'VAS scores', 'analgesia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0167914', 'cui_str': 'TAPB-H'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",48.0,0.0720791,"Statistically significant higher VAS scores in the SCI group 4 hours postoperatively was recorded, both at rest and during movement, compared with both TABP and RSB groups.","[{'ForeName': 'Maha A', 'Initials': 'MA', 'LastName': 'Abo-Zeid', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Al-Refaey K', 'Initials': 'AK', 'LastName': 'Al-Refaey', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Zeina', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_303_18']
1544,30429744,Assessment of effectiveness of cricoid pressure in preventing gastric insufflation during bag and mask ventilation: A randomized controlled trial.,"Background
Rapid sequence induction and intubation (RSII) with application of ""Cricoid pressure"" and avoidance of ""facemask ventilation"" (FMV) is believed to minimize the risk of pulmonary aspiration of gastric contents during general anesthesia. However, some patients may be at risk of developing hypoxemia and may benefit from FMV during RSII. The purpose of this study was to assess the effectiveness of ""cricoid pressure"" in preventing gastric insufflation during FMV using gastric ultrasonography.
Materials and Methods
Eighty-four adult patients were randomized to receive cricoid pressure (CP) or no cricoid pressure (NCP), during FMV after induction of general anesthesia. Gastric antral cross-sectional area (CSA) was measured with ultrasonography before and after FMV in supine and right lateral decubitus positions (LDP). Appearance of ""comet tail"" artifacts created by acoustic shadows of gas in the gastric antrum was noted.
Results
The incidence of insufflation indicated by ""comet tail"" artifacts during FMV was lower in group CP (17 vs 71%; P < 0.001). The lowest P aw at which gastric insufflation occurred was higher in group CP (20 vs 14 cmH 2 O). The change in mean gastric antral CSA was significantly lower in group CP than in group NCP in supine (0.02 vs 0.36 cm 2 , P = 0.012) and right LDP (0.03 vs 0.67 cm 2 , P < 0.001).
Conclusion
Cricoid pressure is effective in preventing gastric insufflation during FMV at P aw less than 20 cmH 2 O. Observation of comet tail artifacts in gastric antrum along with measurement of change in antral CSA on ultrasound examination is a feasible and reliable method to detect gastric insufflation.",2018,"The incidence of insufflation indicated by ""comet tail"" artifacts during FMV was lower in group CP (17 vs 71%; P < 0.001).","['Materials and Methods\n\n\nEighty-four adult patients', 'gastric insufflation during bag and mask ventilation']","['cricoid pressure (CP) or no cricoid pressure (NCP', '\n\n\nRapid sequence induction and intubation (RSII) with application of ""Cricoid pressure"" and avoidance of ""facemask ventilation"" (FMV', 'aw', 'cricoid pressure']","['mean gastric antral CSA', 'lowest P aw at which gastric insufflation', 'right LDP', 'incidence of insufflation indicated by ""comet tail"" artifacts during FMV', 'Gastric antral cross-sectional area (CSA']","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0412767', 'cui_str': 'Rapid sequence induction (procedure)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0232013', 'cui_str': 'Pressure difference between alveoli and mouth (observable entity)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0085089', 'cui_str': 'Artifacts'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",84.0,0.0765673,"The incidence of insufflation indicated by ""comet tail"" artifacts during FMV was lower in group CP (17 vs 71%; P < 0.001).","[{'ForeName': 'Arumugam', 'Initials': 'A', 'LastName': 'Vasudevan', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharlal Institute of Postgrauate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Suganya', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharlal Institute of Postgrauate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Stalin', 'Initials': 'S', 'LastName': 'Vinayagam', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharlal Institute of Postgrauate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Govindarajalou', 'Initials': 'G', 'LastName': 'Ramkumar', 'Affiliation': 'Department of Radiodiagnosis, Jawaharlal Institute of Postgrauate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Muthapillai', 'Initials': 'M', 'LastName': 'Senthilnathan', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharlal Institute of Postgrauate Medical Education and Research, Puducherry, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_240_18']
1545,30371800,Final Analysis of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230.,"Premature menopause is a serious long-term side effect of chemotherapy. We evaluated long-term pregnancy and disease-related outcomes for patients in S0230/POEMS, a study in premenopausal women with stage I-IIIA estrogen receptor-negative, progesterone receptor-negative breast cancer to be treated with cyclophosphamide-containing chemotherapy. Women were randomly assigned to standard chemotherapy with or without goserelin, a gonadotropin-releasing hormone agonist, and were stratified by age and chemotherapy regimen. All statistical tests were two-sided. Of 257 patients, 218 were eligible and evaluable (105 in the chemotherapy + goserelin arm and 113 in the chemotherapy arm). More patients in the chemotherapy + goserelin arm reported at least one pregnancy vs the chemotherapy arm (5-year cumulative incidence = 23.1%, 95% confidence interval [CI] = 15.3% to 31.9%; and 12.2%, 95% CI = 6.8% to 19.2%, respectively; odds ratio = 2.34; 95% CI = 1.07 to 5.11; P = .03). Randomization to goserelin + chemotherapy was associated with a nonstatistically significant improvement in disease-free survival (hazard ratio [HR] = 0.55; 95% CI = 0.27 to 1.10; P = .09) and overall survival (HR = 0.45; 95% CI = 0.19 to 1.04; P = .06). In this long-term analysis of POEMS/S0230, we found continued evidence that patients randomly assigned to receive goserelin + chemotherapy were not only more likely to avoid premature menopause, but were also more likely to become pregnant without adverse effect on disease-related outcomes.",2019,Randomization to goserelin + chemotherapy was associated with a nonstatistically significant improvement in disease-free survival (hazard ratio [HR] = 0.55; 95% CI = 0.27 to 1.10; P = .09) and overall survival (HR = 0.45; 95% CI = 0.19 to 1.04; P = .06).,"['patients in S0230/POEMS, a study in premenopausal women with stage I-IIIA estrogen receptor-negative, progesterone receptor-negative breast cancer', '257 patients, 218 were eligible and evaluable (105 in the chemotherapy + goserelin arm and 113 in the chemotherapy arm']","['standard chemotherapy with or without goserelin, a gonadotropin-releasing hormone agonist', 'chemotherapy + goserelin', 'cyclophosphamide-containing chemotherapy', 'goserelin + chemotherapy']","['disease-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4546716', 'cui_str': '113In isotope'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",257.0,0.205186,Randomization to goserelin + chemotherapy was associated with a nonstatistically significant improvement in disease-free survival (hazard ratio [HR] = 0.55; 95% CI = 0.27 to 1.10; P = .09) and overall survival (HR = 0.45; 95% CI = 0.19 to 1.04; P = .06).,"[{'ForeName': 'Halle C F', 'Initials': 'HCF', 'LastName': 'Moore', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kelly-Anne', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Boyle', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hitre', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Moseley', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Porter', 'Affiliation': 'Auckland Regional Cancer and Blood Service, Auckland, New Zealand.'}, {'ForeName': 'Prudence A', 'Initials': 'PA', 'LastName': 'Francis', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Goldstein', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Gomez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.'}, {'ForeName': 'Carlos S', 'Initials': 'CS', 'LastName': 'Vallejos', 'Affiliation': 'Oncosalud AUNA, Lima, Peru.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Agustin A', 'Initials': 'AA', 'LastName': 'Garcia', 'Affiliation': 'Louisiana State University Health Sciences Center, New Orleans, LA.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Seattle Cancer Care Alliance, and University of Washington, Seattle, WA.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Lombard', 'Affiliation': 'Calvary Mater Hospital, Newcastle, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Forbes', 'Affiliation': 'Breast Cancer Trials Australia and New Zealand (BCT-ANZ), Newcastle, Australia.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'The Angeles Clinic and Research Institute, Santa Monica, CA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, KS.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Meyskens', 'Affiliation': 'University of California at Irvine Chao Family Comprehensive Cancer Center, Orange, CA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Medical Center, Cardinal Bernardin Cancer Center, Maywood, IL.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djy185']
1546,30661093,"Effect of endometrial injury on in vitro fertilization pregnancy rates: a randomized, multicentre study.","PURPOSE
To determine if endometrial injury prior to the first or second in vitro fertilization (IVF) cycle affects clinical pregnancy rates.
METHODS
This study was a randomized, multicentre, controlled study performed at three Canadian outpatient fertility clinics. Patients undergoing their first or second IVF cycle were randomized to a single endometrial injury 5-10 days prior to the start of gonadotropins in an IVF cycle compared to no injury. The primary outcome was clinical pregnancy rate. Secondary outcomes were live birth rates, implantation rate, endometrial thickness, number of oocytes retrieved and the rate of embryo cryopreservation.
RESULTS
Fifty-one women were randomized (25 in the en dometrial injury group and 26 in the control group); however, the study was terminated prematurely due to slow recruitment (target 332 patients). Groups were similar at baseline for: age, duration of infertility, BMI, day 3 FSH, and the number having first IVF cycle. The groups were similar for gonadotropin dose, endometrial thickness, number of oocytes retrieved, and embryo cryopreservation rate. The clinical pregnancy rate in the endometrial injury group was 52% (13/25) and 46% (12/26) in the control group (p = 0.45). Live birth rate in the endometrial injury group was 52% (13/25) and 35% (9/26) in the control group (p = 0.17). The implantation rate was also similar (58% vs. 45%, p = 0.17).
CONCLUSIONS
This study did not detect a difference in implantation, clinical pregnancy or live birth rates; however, the lack of difference in this study may be because it was underpowered. CLINICAL TRIALS REGISTRATIONS: gov: NCT01983423.",2019,"The groups were similar for gonadotropin dose, endometrial thickness, number of oocytes retrieved, and embryo cryopreservation rate.","['Patients undergoing their first or second IVF cycle', 'Fifty-one women were randomized (25 in the en dometrial injury group and 26 in the control group); however, the study was terminated prematurely due to slow recruitment (target 332 patients', 'three Canadian outpatient fertility clinics']",[],"['live birth rates, implantation rate, endometrial thickness, number of oocytes retrieved and the rate of embryo cryopreservation', 'gonadotropin dose, endometrial thickness, number of oocytes retrieved, and embryo cryopreservation rate', 'implantation, clinical pregnancy or live birth rates', 'clinical pregnancy rate', 'implantation rate', 'Live birth rate', 'vitro fertilization pregnancy rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",[],"[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0010405', 'cui_str': 'Cryofixation'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}]",51.0,0.246565,"The groups were similar for gonadotropin dose, endometrial thickness, number of oocytes retrieved, and embryo cryopreservation rate.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Pacific Centre for Reproductive Medicine, 3rd Floor, 9888 Jasper Avenue NW, Edmonton, AB, T5J 5C6, Canada.'}, {'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'Liu', 'Affiliation': 'Mount Sinai Fertility, 250 Dundas St W, 7th floor, Toronto, ON, M5T 2Z5, Canada. Kimberly.liu@sinaihealthsystem.ca.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Laskin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Havelock', 'Affiliation': 'Pacific Centre for Reproductive Medicine, 3rd Floor, 9888 Jasper Avenue NW, Edmonton, AB, T5J 5C6, Canada.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05044-9']
1547,31654645,Comparison of Low Pre-Emptive Oral Doses of Celecoxib Versus Acetaminophen for Postoperative Pain Management After Third Molar Surgery: A Randomized Controlled Study.,"PURPOSE
This study aimed to compare the pre-emptive analgesia of oral celecoxib with oral acetaminophen after surgical removal of the mandibular third molars.
MATERIALS AND METHODS
A randomized, double-blinded, placebo-controlled clinical trial was conducted to examine patients presenting with a mandibular third molar for extraction under local anesthesia. The participants were randomized to receive a preoperative oral dose of celecoxib or acetaminophen as the predictor variable. The primary outcome variable was postoperative pain measured on a visual analog scale at different time points. The secondary outcome variable was the amount of postoperative analgesic medication taken in both groups. Statistical analyses included descriptive statistics, the t test, and the Pearson χ 2 test. Significance was set at P < .05. The overall survival (interval to the first intake of ibuprofen) of the patients in each group was evaluated using Kaplan-Meier curves and log-rank analyses.
RESULTS
Sixty participants were randomly divided into either the celecoxib group or acetaminophen group. The postoperative pain scores in the celecoxib group were significantly lower than those in the acetaminophen group at 4, 6, 8, and 12 hours (P = .008, P = .001, P = .021, and P = .011, respectively). The number of patients who did not require analgesics in the celecoxib group was less than that in the acetaminophen group (P = .018). The average amount of rescue analgesic medication in the celecoxib group (0.6 ± 0.8 dose) was significantly lower than that in the acetaminophen group (1.3 ± 1.0 doses) (P = .002). The Kaplan-Meier curve indicated that celecoxib resulted in long-term survival of the patients who did not receive rescue analgesic medication (P = .0055).
CONCLUSIONS
Celecoxib exhibits a significant pre-emptive analgesic effect, thereby reducing the use of postoperative analgesics after removal of the third molar.",2020,"The postoperative pain scores in the celecoxib group were significantly lower than those in the acetaminophen group at 4, 6, 8, and 12 hours (P = .008, P = .001, P = .021, and P = .011, respectively).","['patients presenting with a mandibular third molar for extraction under local anesthesia', 'Sixty participants']","['Celecoxib', 'celecoxib or acetaminophen', 'Celecoxib Versus Acetaminophen', 'placebo', 'celecoxib', 'acetaminophen', 'Low Pre', 'celecoxib with oral acetaminophen']","['postoperative pain scores', 'overall survival', 'amount of postoperative analgesic medication taken', 'average amount of rescue analgesic medication', 'postoperative pain measured on a visual analog scale', 'Postoperative Pain Management']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.263955,"The postoperative pain scores in the celecoxib group were significantly lower than those in the acetaminophen group at 4, 6, 8, and 12 hours (P = .008, P = .001, P = .021, and P = .011, respectively).","[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Attending Physician, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Rong-Tao', 'Initials': 'RT', 'LastName': 'Yang', 'Affiliation': 'Associate Professor, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Lv', 'Affiliation': 'Associate Professor, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Hai-Hua', 'Initials': 'HH', 'LastName': 'Zhou', 'Affiliation': 'Associate Professor, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Chief Physician, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China. Electronic address: zhili@whu.edu.cn.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.022']
1548,31686255,High-power therapeutic ultrasound for treatment of abdominal localized adiposity-double-blind randomized clinical trial.,"This study aimed to evaluate the effects of high-power therapeutic ultrasound in the treatment of abdominal localized adiposity in an isolated manner, with the use of neutral gel comparing ultrasonic application with 5% lipolytic active caffeine gel (phonophoresis). A total of 90 healthy women aged between 18 and 40 years were randomized and divided into two groups. The volunteers underwent anamnesis evaluation, perimetry, bioimpedance, ultrasound examination, and blood tests (complete lipidogram, creatinine, and vitamin D) before and after the end of the 10-session ultrasound protocol (3 MHz, 2 W/cm 2 , and 30w). Comparisons between groups and pre-post evaluation were performed by a two-way repeated-measures analysis of variance. Values of p < 0.05 indicated statistical significance. The results demonstrated a significant reduction in both groups, for the perimetry (p < 0.001) and measurements of adipose tissue thickness (p < 0.001). The examinations exhibited a significant alteration only of the complete lipidogram, but without significance (p > 0.05). When comparing the groups, no statistically significant difference was identified in any of the analyzed parameters. The high-power ultrasonic therapy is efficient in reducing localized adiposity, regardless of whether it is applied with neutral gel or 5% caffeine gel.",2020,"The results demonstrated a significant reduction in both groups, for the perimetry (p < 0.001) and measurements of adipose tissue thickness (p < 0.001).",['90 healthy women aged between 18 and 40 years'],"['neutral gel comparing ultrasonic application with 5% lipolytic active caffeine gel (phonophoresis', 'high-power therapeutic ultrasound', 'High-power therapeutic ultrasound']","['perimetry, bioimpedance, ultrasound examination, and blood tests (complete lipidogram, creatinine, and vitamin D', 'adipose tissue thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0031582', 'cui_str': 'Phonophoresis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0041620', 'cui_str': 'Ultrasonic Therapy'}]","[{'cui': 'C0031061', 'cui_str': 'Perimetry'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}]",90.0,0.0472504,"The results demonstrated a significant reduction in both groups, for the perimetry (p < 0.001) and measurements of adipose tissue thickness (p < 0.001).","[{'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'da Silva Siqueira', 'Affiliation': 'Graduate Program in Electrical and Computer Engineering (CPGEI), Federal University of Technology Paraná (UTFPR), Curitiba, PR, Brazil. karinasiqueirafisio@gmail.com.'}, {'ForeName': 'Joaquim Miguel', 'Initials': 'JM', 'LastName': 'Maia', 'Affiliation': 'Electronics Engineering Department (DAELN) and Graduate Program in Electrical and Computer Engineering (CPGEI), Federal University of Technology Paraná (UTFPR), Curitiba, PR, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02895-1']
1549,31683021,Efficacy of Interpretation Bias Modification in Patients With Chronic Pain.,"Patients with chronic pain demonstrate interpretational bias to pain, and models of pain suggest interpretational bias affects subsequent pain experience. This study developed an interpretation bias modification for pain (IBM-P) and examined its efficacy. A total of 48 patients with chronic pain were recruited and randomly assigned to either the training group (n = 24) or the control group (n = 24). Interpretational bias, negative emotions, and attentional bias to pain-related stimuli were assessed before and after conducting IBM-P. The main results indicated that the training group showed less interpretational bias and negative emotions after IBM-P than the control group. The training group also gazed at neutral words longer than at ""new"" affective pain words after IBM-P than they did prior to the intervention. Furthermore, significant mediating effects of postinterpretational bias were found in the relationship between the group type and postnegative emotions and postdwell time bias. These results suggest that IBM-P can modify interpretational bias which leads to changes in negative emotions and attentional bias. Future research is needed to confirm the effect of modifying interpretational bias and its clinical utility in the field of pain management. PERSPECTIVE: This article investigated the efficacy of IBM-P and suggested that modifying interpretational bias is followed by changes in negative emotions and attentional bias. These findings may help health professionals understand the role of interpretational bias in chronic pain and encourage the potential use of IBM in pain management.",2019,The main results indicated that the training group showed less interpretational bias and negative emotions after IBM-P than the control group.,"['48 patients with chronic pain', 'Patients with Chronic Pain', 'Patients with chronic pain']",['Interpretation Bias Modification'],"['negative emotions and attentional bias', 'Interpretational bias, negative emotions, and attentional bias to pain-related stimuli', 'interpretational bias and negative emotions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",48.0,0.0286894,The main results indicated that the training group showed less interpretational bias and negative emotions after IBM-P than the control group.,"[{'ForeName': 'Jeongwi', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Kyeong-Seok', 'Initials': 'KS', 'LastName': 'Wang', 'Affiliation': 'Hearim Medical Clinic, Daejeon, Republic of Korea.'}, {'ForeName': 'Youn-Hee', 'Initials': 'YH', 'LastName': 'Jung', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Sungkun', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea. Electronic address: sungkunc@cnu.ac.kr.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.10.005']
1550,30679107,"Four courses versus eight courses of adjuvant S-1 for patients with stage II gastric cancer (JCOG1104 [OPAS-1]): an open-label, phase 3, non-inferiority, randomised trial.","BACKGROUND
Postoperative adjuvant chemotherapy with S-1 for 1 year (corresponding to eight courses) is standard care for stage II gastric cancer. Whether the duration of S-1 could be shortened to 6 months (corresponding to four courses) without worsening survival is unclear. The aim of this study was to investigate the non-inferiority of four courses of S-1 compared with eight courses of S-1 for patients with stage II gastric cancer.
METHODS
We did a phase 3, open-label, randomised controlled, non-inferiority trial at 59 hospitals in Japan. Patients aged 20-80 years with stage II adenocarcinoma of the stomach were randomly assigned (1:1) to eight courses or four courses of S-1. Randomisation was done by the Japan Clinical Oncology Group Data Center website, using a minimisation method with a random component using institution, stage (IIA vs IIB), age (<70 years vs ≥70 years), and mode of operation (open gastrectomy with bursectomy vs open gastrectomy without bursectomy vs laparoscopic gastrectomy) as adjustment factors. One course was 80 mg/day per m 2 of S-1 administered for 4 weeks followed by a rest for 2 weeks. The primary endpoint was relapse-free survival, analysed by intention to treat, with a non-inferiority margin for the hazard ratio (HR) set at 1·37. This study is registered at UMIN-Clinical Trial Registry, number UMIN000007306.
FINDINGS
Between Feb 16, 2012, and March 19, 2017, 590 patients were enrolled (295 per group). 528 (89%) patients were analysed at the first planned interim analysis in March, 2017, at which time the point estimate of HR for the four-course group compared with the eight-course group was 2·52 (95% CI 1·11-5·77), which exceeded 1·37 and met the prespecified criteria for early termination. Predictive probability for showing non-inferiority at the final analysis was calculated to be 2·9%. The study was stopped for futility. Updated 3-year relapse-free survival analysed in May, 2017, was 93·1% (95% CI 87·8-96·1) for the eight-course group and 89·8% (84·2-93·5) for the four-course group (HR 1·84, 95% CI 0·93-3·63). The most common grade 3-4 adverse event was neutropenia, observed in 46 (16%) patients in the eight-course group and 51 (17%) patients in the four-course group.
INTERPRETATION
S-1 for 1 year should remain as standard adjuvant chemotherapy for stage II gastric cancer.
FUNDING
Japan Agency for Medical Research and Development; the Ministry of Health, Labour and Welfare of Japan; the National Cancer Center Research and Development Fund, Japan.",2019,"The most common grade 3-4 adverse event was neutropenia, observed in 46 (16%) patients in the eight-course group and 51 (17%) patients in the four-course group.
","['patients with stage II gastric cancer (JCOG1104 [OPAS-1', 'stage II gastric cancer', 'Between Feb 16, 2012, and March 19, 2017', '590 patients were enrolled (295 per group', 'Patients aged 20-80 years with stage II adenocarcinoma of the stomach', '59 hospitals in Japan', 'patients with stage II gastric cancer']","['S-1', 'mode of operation (open gastrectomy with bursectomy vs open gastrectomy without bursectomy vs laparoscopic gastrectomy', 'adjuvant S-1']","['neutropenia', 'relapse-free survival, analysed by intention to treat, with a non-inferiority margin for the hazard ratio (HR', 'Updated 3-year relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0185298', 'cui_str': 'Resection of bursa'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",590.0,0.245289,"The most common grade 3-4 adverse event was neutropenia, observed in 46 (16%) patients in the eight-course group and 51 (17%) patients in the four-course group.
","[{'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastric Surgery, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan. Electronic address: tayoshik@ncc.go.jp.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Souya', 'Initials': 'S', 'LastName': 'Nunobe', 'Affiliation': 'Gastroenterological Surgery, Cancer Institute Ariake Hospital, Koto-Ku, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Nishida', 'Affiliation': 'Department of Surgery, Keiyukai Sapporo Hospital, Siroishi-Ku, Sapporo, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-Ku, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Kaji', 'Affiliation': 'Department of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan.'}, {'ForeName': 'Norimasa', 'Initials': 'N', 'LastName': 'Fukushima', 'Affiliation': 'Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Hato', 'Affiliation': 'Department of Surgery, National Hospital Organization, Shikoku Cancer Center, Minami-umemotocho, Matsuyama Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Choda', 'Affiliation': 'Department of Surgery, Hiroshima City Hiroshima Citizens Hospital, Naka-Ku, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'Department of Digestive Surgery, Niigata Cancer Center Hospital, Kawagishimachi, Chuo-Ku, Niigata, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Gifu University, Graduate School of Medicine, Gifu City, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Chikusa-ku, Nagoya.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeno', 'Affiliation': 'Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yasuda', 'Affiliation': 'Department of Gastroenterological Surgery, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kawachi', 'Affiliation': 'Department of Surgery, Nagaoka Chuo General Hospital, Nagaoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sano', 'Affiliation': 'Gastroenterological Surgery, Cancer Institute Ariake Hospital, Koto-Ku, Tokyo, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Sasako', 'Affiliation': 'Department of Multidisciplinary Surgical Oncology, Hyogo College of Medicine, Nishinomiya, Japan.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(18)30383-2']
1551,32408022,Supporting Syrian families displaced by armed conflict: A pilot randomized controlled trial of the Caregiver Support Intervention.,"BACKGROUND
The impact of armed conflict and displacement on children's mental health is strongly mediated by compromised parenting stemming from persistently high caregiver stress. Parenting interventions for refugees emphasize the acquisition of parenting knowledge and skills, while overlooking the deleterious effects of chronic stress on parenting. War Child Holland's Caregiver Support Intervention (CSI) aims to strengthen parenting by lowering stress and improving psychosocial wellbeing among refugee parents, while also increasing knowledge and skill related to positive parenting. The CSI is a nine-session group intervention delivered by non-specialist providers.
OBJECTIVE
We describe the findings of a two-arm pilot randomized controlled trial of the CSI with Syrian refugees in Lebanon. The primary aim was to test the feasibility of our study methodology prior to conducting a definitive RCT.
METHODS
We recruited 78 families (151 parents), who were randomized to the CSI or a waitlist control group. Data were collected at baseline and post-intervention.
RESULTS
Randomization was successful, retention was high (99 %), as was intervention completion (95 % among women, 86 % among men). Implementation fidelity was excellent. Blinding was largely, though not completely effective. The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management. CSI parents reported increased child psychosocial wellbeing. Control families showed no significant change on any variable.
CONCLUSIONS
Findings demonstrate the feasibility of our methodology for a definitive RCT, and suggest that the CSI shows promise as a scalable approach to strengthening parenting in refugee communities. Trial registration # ISRCTN33665023.",2020,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","['78 families (151 parents', ""children's mental health""]","['CSI', 'Caregiver Support Intervention', ""War Child Holland's Caregiver Support Intervention (CSI""]","['parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management', 'child psychosocial wellbeing']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",78.0,0.126032,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Miller', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Kenneth.Miller@warchild.nl.'}, {'ForeName': 'Gabriela V', 'Initials': 'GV', 'LastName': 'Koppenol-Gonzalez', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Gabriela.Koppenol@warchild.nl.'}, {'ForeName': 'Maguy', 'Initials': 'M', 'LastName': 'Arnous', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Maguy.Arnous@warchild.nl.'}, {'ForeName': 'Fadila', 'Initials': 'F', 'LastName': 'Tossyeh', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Fadila.Tossyeh@warchild.nl.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Harvard University, United States. Electronic address: Alexandra.chen@post.harvard.edu.'}, {'ForeName': 'Nayla', 'Initials': 'N', 'LastName': 'Nahas', 'Affiliation': 'University of Balamand, Lebanon. Electronic address: Nayla.Nahas@balamand.edu.lb.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands; Amsterdam Institute of Social Science Research, University of Amsterdam, The Netherlands. Electronic address: Mark.Jordans@warchild.nl.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104512']
1552,30425008,The use of goal attainment scaling during clinical medication review in older persons with polypharmacy.,"BACKGROUND
Studies have shown that a clinical medication review (CMR) reduces drug-related problems (DRPs), but the effects on clinical outcomes are less clear. Perhaps, CMRs in older persons could me more effective when they focus on patients' personal goals and health-related complaints.
OBJECTIVE
The aim of this study was to investigate whether goal attainment scaling (GAS) is a useful tool for determining goals and monitoring their attainment during CMR.
METHODS
This study was an analysis based on data of the intervention group of the DREAMeR-study; a randomised controlled trial investigating the effects of CMR in primary care. 315 persons aged ≥70 years using ≥7 drugs were randomised to the intervention: a CMR focused on personal goals using GAS. Outcome measures were: percentage of persons with health-related goals, attainment of goals measured with GAS-scores after three and six months, type of health-related goals and implementation rates of recommendations for GAS-related DRPs and other DRPs.
RESULTS
A total of 406 health-related goals were set for 283 of 315 included persons (90%). Of the 350 evaluated goals (86%), 37% was attained after three months and 43% after six months. The goals 'reduce pain' (n = 66, 16%), 'improve mobility' (n = 57, 14%) and 'reduce number of pills' (n = 37, 9.1%) were most prevalent. The implementation rate of recommendations for GAS-related DRPs was 81% compared to 62% for not GAS-related DRPs (p < 0.05).
CONCLUSION
Goal setting is important for prioritizing the most important problems during clinical medication review and Goal Attainment Scaling seems to be a useful tool for monitoring the attainment of these goals.",2019,"The implementation rate of recommendations for GAS-related DRPs was 81% compared to 62% for not GAS-related DRPs (p < 0.05).
","['315 persons aged ≥70 years using ≥7 drugs', 'older persons', 'A total of 406 health-related goals were set for 283 of 315 included persons (90', 'older persons with polypharmacy']","['CMR', 'goal attainment scaling (GAS']","['pain', 'reduce number of pills', 'percentage of persons with health-related goals, attainment of goals measured with GAS-scores after three and six months, type of health-related goals and implementation rates of recommendations for GAS-related DRPs and other DRPs', 'improve mobility', 'implementation rate of recommendations for GAS-related DRPs']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0222045'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",,0.0494582,"The implementation rate of recommendations for GAS-related DRPs was 81% compared to 62% for not GAS-related DRPs (p < 0.05).
","[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Verdoorn', 'Affiliation': 'Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands; SIR Institute for Pharmacy Practice and Policy, Leiden, the Netherlands. Electronic address: s.verdoorn@sirstevenshof.nl.'}, {'ForeName': 'Jeanet', 'Initials': 'J', 'LastName': 'Blom', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vogelzang', 'Affiliation': 'Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Henk-Frans', 'Initials': 'HF', 'LastName': 'Kwint', 'Affiliation': 'SIR Institute for Pharmacy Practice and Policy, Leiden, the Netherlands.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine, section Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marcel L', 'Initials': 'ML', 'LastName': 'Bouvy', 'Affiliation': 'Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands; SIR Institute for Pharmacy Practice and Policy, Leiden, the Netherlands.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2018.11.002']
1553,30429732,Enteral nutrition with omega-3 fatty acids in critically ill septic patients: A randomized double-blinded study.,"Purpose
The present study was done to investigate the effect of the enteral omega-3 fatty acids on critically ill septic patients.
Methods
A total of 110 critically ill septic patients were divided into two groups, 55 patients in each. Group A received enteral nutrition with 1000 mg omega-3 three times daily and Group B received enteral nutrition without omega-3. Demographic data, sepsis characteristics, number of patients required invasive ventilation, ventilation days, Intensive Care Unit (ICU) sequential organ failure assessment (SOFA) score, organ failure-free days, hemodynamic failure-free days, ICU stay, ICU, and hospital outcome were recorded.
Results
Leukocytic count and C-reactive protein were higher in Group B during ICU stay ( P = 0.010 and 0.003, respectively). The number of organ and hemodynamic failure-free days was higher in Group A ( P < 0.05). Overall, ICU SOFA score was higher in Group B ( P = 0.03). There was no difference in the number of patients requiring mechanical ventilation ( P = 0.41). ICU stay was longer in Group B ( P = 0.019); however, post-ICU hospital stay was similar in both groups. There were no differences regarding ICU and hospital survivors ( P > 0.05).
Conclusions
Enteral nutrition with omega-3 can improve organ function and decrease ICU stay in septic patients. Omega-3 fatty acids do not affect ICU mortality or decrease the post-ICU hospital stay.",2018,"Results
Leukocytic count and C-reactive protein were higher in Group B during ICU stay ( P = 0.010 and 0.003, respectively).","['110 critically ill septic patients', 'septic patients', 'critically ill septic patients']","['enteral omega-3 fatty acids', 'enteral nutrition with 1000 mg omega-3 three times daily and Group B received enteral nutrition without omega-3', 'Omega-3 fatty acids', 'Enteral nutrition with omega-3 fatty acids']","['post-ICU hospital stay', 'Overall, ICU SOFA score', 'number of organ and hemodynamic failure-free days', 'Leukocytic count and C-reactive protein', 'ICU and hospital survivors', 'organ function and decrease ICU stay', 'ICU stay', 'Demographic data, sepsis characteristics, number of patients required invasive ventilation, ventilation days, Intensive Care Unit (ICU) sequential organ failure assessment (SOFA) score, organ failure-free days, hemodynamic failure-free days, ICU stay, ICU, and hospital outcome', 'ICU mortality', 'number of patients requiring mechanical ventilation']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0556984', 'cui_str': 'Three times daily (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]",110.0,0.104162,"Results
Leukocytic count and C-reactive protein were higher in Group B during ICU stay ( P = 0.010 and 0.003, respectively).","[{'ForeName': 'Ezzeldin Saleh', 'Initials': 'ES', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Faculty of Medicine, Menoufia University, Shebeen El-Kom, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_50_18']
1554,30429738,Ultrasound-guided serratus anterior plane block versus thoracic paravertebral block for perioperative analgesia in thoracotomy.,"Background
Thoracotomy needs adequate powerful postoperative analgesia. This study aims to compare the safety and efficacy of ultrasound (US)-guided serratus anterior plane block (SAPB) and thoracic paravertebral block (TPVB) for perioperative analgesia in cancer patients having lung lobectomy.
Patients and Methods
This clinical trial involved 90 patients with lung cancer scheduled for lung lobectomy randomly divided into three groups according to the type of preemptive regional block. Group TPVB received US-guided TPVB. In Group SAPB, US-guided SAPB was performed. The patients of the control Group received general anesthesia alone. The outcome measures were postoperative visual analog scale (VAS) score, intraoperative fentanyl consumption, time of first rescue analgesic, total dose postoperative analgesic, and drug-related adverse effects.
Results
Analgesia was adequate in TPVB and SAPB groups up to 24 h. VAS score was comparable in TPVB and SAPB groups and significantly lower compared to control group up to 9 h postoperatively. At 12 and 24 h, TPVB group had significantly lower VAS score relative to SAPB and control groups. Total intraoperative fentanyl consumption was significantly lower in TPVB and SAPB Groups compared to control group. The majority of TPVB Group cases did not need rescue morphine, while the majority of control group needed two doses ( P < 0.001). The hemodynamic variables were stable in all patients. Few cases reported trivial adverse effects.
Conclusion
Preemptive TPVB and SAPB provide comparable levels of adequate analgesia for the first 24 h after thoracotomy. TPVB provided better analgesia after 12 h. The two procedures reduce intraoperative fentanyl and postoperative morphine consumption.",2018,Analgesia was adequate in TPVB and SAPB groups up to 24 h. VAS score was comparable in TPVB and SAPB groups and significantly lower compared to control group up to 9 h postoperatively.,"['90 patients with lung cancer scheduled for lung lobectomy', 'cancer patients having lung lobectomy']","['TPVB', 'general anesthesia alone', 'Ultrasound-guided serratus anterior plane block versus thoracic paravertebral block', 'ultrasound (US)-guided serratus anterior plane block (SAPB) and thoracic paravertebral block (TPVB']","['safety and efficacy', 'hemodynamic variables', 'intraoperative fentanyl and postoperative morphine consumption', 'adequate analgesia', 'postoperative visual analog scale (VAS) score, intraoperative fentanyl consumption, time of first rescue analgesic, total dose postoperative analgesic, and drug-related adverse effects', 'VAS score', 'Analgesia', 'Total intraoperative fentanyl consumption', 'trivial adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung (procedure)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",90.0,0.0262511,Analgesia was adequate in TPVB and SAPB groups up to 24 h. VAS score was comparable in TPVB and SAPB groups and significantly lower compared to control group up to 9 h postoperatively.,"[{'ForeName': 'Fady Samy', 'Initials': 'FS', 'LastName': 'Saad', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Samia Yehia', 'Initials': 'SY', 'LastName': 'El Baradie', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Maha Abdel Wahab', 'Initials': 'MAW', 'LastName': 'Abdel Aliem', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Metwally', 'Initials': 'MM', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Tamer Ahmed Mahmoud', 'Initials': 'TAM', 'LastName': 'Kotb', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_153_18']
1555,31863347,Salt intake in mineralocorticoid receptor antagonist-treated primary aldosteronism: foe or ally?,"Mild hyperkalemia is a common side effect of mineralocorticoid receptor antagonist (MRA) treatment of patients with primary aldosteronism (PA), which can be worsened by instructions to minimize salt intake. Our objective was to evaluate the effect of salt consumption on serum potassium levels and mean, mean minimal, and mean maximal systolic and diastolic blood pressure (BP) in MRA-treated hyperkalemic PA patients under relative salt restriction. Seventeen consecutive mildly hyperkalemic MRA-treated PA patients aged 66.3 ± 8.37 years were recruited. Body mass index (BMI) and BP were assessed, and serum and 24-h urinary sodium and potassium levels, plasma renin, and serum aldosterone were measured, while patients followed a relatively salt-restricted diet, after 1 month of controlled salt supplementation (usual salt-restricted diet plus 4 g salt/day) and after 6 months on instructions for free dietary salt consumption. Baseline salt consumption was additionally evaluated in two more patient groups (normotensive subjects and normokalemic MRA-treated PA patients). One month of controlled salt supplementation (24-h urine sodium (median, min, max): 195.2 (120.30-275.20) vs 110.13 (34.30-139.20) mEq/day, p < 0.001) resulted in increased kaliuresis (62.25 (40.69-97.0) vs 54.0 (23.28-79.60) mEq/day, p = 0.001) and a decrease of serum potassium (5.2 (5-5.70) vs 4.6 (3.8-5.1) mEq/L, p < 0.001), while serum sodium (139 (133-141) vs 1 39 (135-144) mEq/L) and mean systolic (130 (105-141 vs. 130 (106-141) mmHg) and diastolic (76 (53-85) vs75 (53-84) mmHg) BP remained stable. These findings were unchanged after 6 months of free salt consumption. BMI remained constant, while plasma renin and serum aldosterone decreased following salt repletion. Adequate salt consumption attenuates MRA-induced hyperkalemia in relatively salt-restricted PA patients without affecting BP or BMI.",2020,Adequate salt consumption attenuates MRA-induced hyperkalemia in relatively salt-restricted PA patients without affecting BP or BMI.,"['MRA-treated hyperkalemic PA patients under relative salt restriction', 'Seventeen consecutive mildly hyperkalemic MRA-treated PA patients aged 66.3\u2009±\u20098.37\xa0years were recruited', 'patients with primary aldosteronism (PA']","['mineralocorticoid receptor antagonist (MRA', 'controlled salt supplementation (usual salt-restricted diet plus 4\xa0g salt/day) and after 6\xa0months on instructions for free dietary salt consumption', 'salt consumption']","['mean systolic', 'Mild hyperkalemia', 'increased kaliuresis', 'Baseline salt consumption', 'BMI remained constant, while plasma renin and serum aldosterone', 'serum potassium levels and mean, mean minimal, and mean maximal systolic and diastolic blood pressure (BP', 'serum potassium', 'Body mass index (BMI) and BP were assessed, and serum and 24-h urinary sodium and potassium levels, plasma renin, and serum aldosterone']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1384514', 'cui_str': 'Primary Hyperaldosteronism'}]","[{'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0920110', 'cui_str': 'Kaluresis'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0428395', 'cui_str': 'Aldosterone measurement, serum (procedure)'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0428289', 'cui_str': 'Finding of potassium level (finding)'}]",17.0,0.0232368,Adequate salt consumption attenuates MRA-induced hyperkalemia in relatively salt-restricted PA patients without affecting BP or BMI.,"[{'ForeName': 'Stelios', 'Initials': 'S', 'LastName': 'Fountoulakis', 'Affiliation': ""Department of Endocrinology and Diabetes Center, General Hospital of Athens 'G. Gennimatas', 154 Mesogion Avenue, 11527, Athens, Greece. st_foun@yahoo.com.""}, {'ForeName': 'Labrini', 'Initials': 'L', 'LastName': 'Papanastasiou', 'Affiliation': ""Department of Endocrinology and Diabetes Center, General Hospital of Athens 'G. Gennimatas', 154 Mesogion Avenue, 11527, Athens, Greece.""}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Voulgaris', 'Affiliation': ""Department of Endocrinology and Diabetes Center, General Hospital of Athens 'G. Gennimatas', 154 Mesogion Avenue, 11527, Athens, Greece.""}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Kounadi', 'Affiliation': ""Department of Endocrinology and Diabetes Center, General Hospital of Athens 'G. Gennimatas', 154 Mesogion Avenue, 11527, Athens, Greece.""}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Markou', 'Affiliation': ""Department of Endocrinology and Diabetes Center, General Hospital of Athens 'G. Gennimatas', 154 Mesogion Avenue, 11527, Athens, Greece.""}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Chrousos', 'Affiliation': ""Division of Endocrinology, Metabolism and Diabetes, First Department of Pediatrics, Children's Hospital 'Aghia Sophia', National and Kapodistrian University of Athens Medical School, Athens, Greece.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Piaditis', 'Affiliation': ""Department of Endocrinology and Diabetes Center, General Hospital of Athens 'G. Gennimatas', 154 Mesogion Avenue, 11527, Athens, Greece.""}]","Hormones (Athens, Greece)",['10.1007/s42000-019-00167-9']
1556,30660609,"Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial.","BACKGROUND
There is no recommended therapy for malignant pleural mesothelioma that has progressed after first-line pemetrexed and platinum-based chemotherapy. Disease control has been less than 30% in all previous studies of second-line drugs. Preliminary results have suggested that anti-programmed cell death 1 (PD-1) monoclonal antibody could be efficacious in these patients. We thus aimed to prospectively assess the anti-PD-1 monoclonal antibody alone or in combination with anti-cytotoxic T-lymphocyte protein 4 (CTLA-4) antibody in patients with malignant pleural mesothelioma.
METHODS
This multicentre randomised, non-comparative, open-label, phase 2 trial was done at 21 hospitals in France. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0-1, histologically proven malignant pleural mesothelioma progressing after first-line or second-line pemetrexed and platinum-based treatments, measurable disease by CT, and life expectancy greater than 12 weeks. Patients were randomly allocated (1:1) to receive intravenous nivolumab (3 mg/kg bodyweight) every 2 weeks, or intravenous nivolumab (3 mg/kg every 2 weeks) plus intravenous ipilimumab (1 mg/kg every 6 weeks), given until progression or unacceptable toxicity. Central randomisation was stratified by histology (epithelioid vs non-epithelioid), treatment line (second line vs third line), and chemosensitivity to previous treatment (progression ≥3 months vs <3 months after pemetrexed treatment) and used a minimisation method with a 0·8 random factor. The primary outcome was the proportion of patients who achieved 12-week disease control, assessed by masked independent central review; the primary endpoint would be met if disease control was achieved in at least 40% of patients. The primary endpoint was assessed in the first 108 eligible patients. Efficacy analyses were also done in the intention-to-treat population and safety analyses were done in all patients who received at least one dose of their assigned treatment. This trial is registered at ClinicalTrials.gov, number NCT02716272.
FINDINGS
Between March 24 and August 25, 2016, 125 eligible patients were recruited and assigned to either nivolumab (n=63) or nivolumab plus ipilimumab (n=62). In the first 108 eligible patients, 12-week disease control was achieved by 24 (44%; 95% CI 31-58) of 54 patients in the nivolumab group and 27 (50%; 37-63) of 54 patients in the nivolumab plus ipilimumab group. In the intention-to-treat population, 12-week disease control was achieved by 25 (40%; 28-52) of 63 patients in the nivolumab group and 32 (52%; 39-64) of 62 patients in the combination group. Nine (14%) of 63 patients in the nivolumab group and 16 (26%) of 61 patients in the combination group had grade 3-4 toxicities. The most frequent grade 3 adverse events were asthenia (one [2%] in the nivolumab group vs three [5%] in the combination group), asymptomatic increase in aspartate aminotransferase or alanine aminotransferase (none vs four [7%] of each), and asymptomatic lipase increase (two [3%] vs one [2%]). No patients had toxicities leading to death in the nivolumab group, whereas three (5%) of 62 in the combination group did (one fulminant hepatitis, one encephalitis, and one acute kidney failure).
INTERPRETATION
Anti-PD-1 nivolumab monotherapy or nivolumab plus anti-CTLA-4 ipilimumab combination therapy both showed promising activity in relapsed patients with malignant pleural mesothelioma, without unexpected toxicity. These regimens require confirmation in larger clinical trials.
FUNDING
French Cooperative Thoracic Intergroup.",2019,"The most frequent grade 3 adverse events were asthenia (one [2%] in the nivolumab group vs three [5%] in the combination group), asymptomatic increase in aspartate aminotransferase or alanine aminotransferase (none vs four [7%] of each), and asymptomatic lipase increase (two [3%] vs one [2%]).","['21 hospitals in France', 'Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0-1, histologically proven malignant pleural mesothelioma progressing after first-line or second-line pemetrexed and platinum-based treatments, measurable disease by CT, and life expectancy greater than 12 weeks', 'relapsed patients with malignant pleural mesothelioma', '108 eligible patients', 'patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2', 'Between March 24 and August 25, 2016, 125 eligible patients', 'patients with malignant pleural mesothelioma']","['intravenous nivolumab', 'nivolumab plus anti-CTLA-4 ipilimumab combination therapy', 'nivolumab', 'anti-PD-1 monoclonal antibody alone or in combination with anti-cytotoxic T-lymphocyte protein 4 (CTLA-4) antibody', 'nivolumab plus ipilimumab', 'Nivolumab or nivolumab plus ipilimumab', 'intravenous ipilimumab']","['aspartate aminotransferase or alanine aminotransferase', 'proportion of patients who achieved 12-week disease control', 'asymptomatic lipase increase', 'grade 3-4 toxicities', 'toxicities leading to death', 'asthenia', 'disease control']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0039195', 'cui_str': 'Cell-Mediated Lympholytic Cells'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0549475', 'cui_str': 'Lipase increased'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}]",125.0,0.158461,"The most frequent grade 3 adverse events were asthenia (one [2%] in the nivolumab group vs three [5%] in the combination group), asymptomatic increase in aspartate aminotransferase or alanine aminotransferase (none vs four [7%] of each), and asymptomatic lipase increase (two [3%] vs one [2%]).","[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Scherpereel', 'Affiliation': 'Department of Pulmonary and Thoracic Oncology, University of Lille, University Hospital (CHU) of Lille, Lille, France; French National Network of Clinical Expert Centers for Malignant Pleural Mesothelioma Management (MESOCLIN), Lille, France. Electronic address: arnaud.scherpereel@chru-lille.fr.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Department of Pneumology, University Hospital of Toulouse, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lantuejoul', 'Affiliation': 'Department of BioPathology, MESOPATH, Centre de Lutte Contre le Cancer Léon Bérard, Lyon, France; University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Dô', 'Affiliation': 'Department of Pneumology, Centre de Lutte Contre le Cancer Baclesse, Caen, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bylicki', 'Affiliation': ""Department of Pneumology, Hôpital d'instruction des Armées, Percy, Clamart, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': 'Department of Pneumology, Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Corre', 'Affiliation': 'Department of Pneumology, University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Department of Pneumology, Hôpital Sainte-Musse, Toulon, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Locatelli-Sanchez', 'Affiliation': 'Department of Pneumology, Centre Hospitalier Lyon-Sud Pierre-Bénite, Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Department of Pneumology, Le Mans Regional Hospital, Le Mans, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Guisier', 'Affiliation': 'Department of Pneumology, University Hospital of Rouen, Rouen, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Urban', 'Affiliation': 'Department of Pneumology, University Hospital of CHU Angers, Angers, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ligeza-Poisson', 'Affiliation': ""Department of Medical Oncology, Clinique Mutualiste de l'Estuaire, Saint-Nazaire, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Department of Thoracic Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Amour', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique IFCT, Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique IFCT, Paris, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Department of Pneumology, University Hospital of Grenoble, Grenoble, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': 'University Hospital Bichat Claude Bernard, Assistance Publique-Hôpitaux de Paris, Paris-Diderot University Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30765-4']
1557,30852564,Health-Related Quality of Life for Long-Acting Octreotide versus Placebo in Patients with Metastatic Midgut Neuroendocrine Tumors in the Phase 3 PROMID Trial.,"BACKGROUND
In the phase IIIb PROMID study, octreotide long-acting significantly extended time to tumor progression compared with placebo in treatment-naïve patients with well-differentiated metastatic midgut neuroendocrine tumors. We report post hoc analyses for health-related quality of life (HRQoL).
METHODS
HRQoL was measured with EORTC QLQ-C30, a 30-item self-report questionnaire (5 functional, 1 global, 9 symptom scales). Assessments were completed at baseline and every 12 weeks until tumor progression. Time to definitive deterioration (TDD; worsening of ≥10 points without further improvement) was analyzed with the Kaplan-Meier method. Linear mixed models were fit to assess change from baseline in QLQ-C30 scores by treatment arm over time.
RESULTS
Among 85 patients, 82 (96%) completed the QLQ-C30 at baseline. There were few events of definitive deterioration for many scales. Significantly longer TDD was reported for long-acting octreotide versus placebo for fatigue (median 18.5 months vs. 6.8; p = 0.0006), pain (not reached [NR] vs. 18.2; p = 0.0435) and insomnia (NR vs. 16.4; p = 0.0046). Change from baseline to week 24 fatigue scores were stable for long-acting octreotide (mean 0.78; 95% CI -6.3 to 7.8) but worsened for placebo (mean 9.1; 95% CI 1.9-16.4), and for diarrhea there were improvements for long-acting octreotide (mean -8.0; 95% CI -19.6 to 3.5) and worsening for placebo (mean 11.2; 95% CI -0.7 to 23.1).
CONCLUSIONS
HRQoL was maintained with few deteriorations in long-acting octreotide patients, whereas there was earlier and/or more deterioration in placebo patients. In long-acting octreotide patients, HRQoL was maintained or improved for the clinically important neuroendocrine tumor symptoms such as fatigue, insomnia, diarrhea and pain, whereas placebo patients experienced a deterioration of HRQoL scores for these symptoms.",2019,"In octreotide long-acting patients, HRQoL was maintained or improved for the clinically important NET symptoms such as fatigue, insomnia, diarrhea and pain, whereas placebo patients experienced a deterioration of HRQoL on these symptoms.","['patients with metastatic midgut neuroendocrine tumors', 'patients']","['octreotide long-acting vs. placebo', 'placebo', 'octreotide']","['pain', 'QLQ-C30 scores', 'health-related quality of life (HRQoL', 'fatigue, insomnia, diarrhea and pain', 'QLQ-C30', 'diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0231052', 'cui_str': 'Primitive midgut structure'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}]","[{'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.1518,"In octreotide long-acting patients, HRQoL was maintained or improved for the clinically important NET symptoms such as fatigue, insomnia, diarrhea and pain, whereas placebo patients experienced a deterioration of HRQoL on these symptoms.","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rinke', 'Affiliation': 'Department of Gastroenterology and Endocrinology, Philipps University of Marburg, Marburg, Germany, sprengea@uni-marburg.de.'}, {'ForeName': 'Maureen P', 'Initials': 'MP', 'LastName': 'Neary', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Eriksson', 'Affiliation': 'ICON plc, Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hunger', 'Affiliation': 'ICON plc, Munich, Germany.'}, {'ForeName': 'Thinh', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Novartis Ireland Ltd., Dublin, Ireland.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Karli', 'Affiliation': 'Novartis Ireland Ltd., Dublin, Ireland.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Arnold', 'Affiliation': 'Department of Gastroenterology and Endocrinology, Philipps University of Marburg, Marburg, Germany.'}]",Neuroendocrinology,['10.1159/000499469']
1558,30658560,Weight-Loss Resilience Among Low-Income Postpartum Women: Association With Health Habits.,"Using a weight resilience framework, health habits of diet and physical activity, social support, and perceived stress were compared in women who lost weight (resilient) and those who did not lose or gained weight (nonresilient) during a weight-loss intervention. Participants were low-income postpartum women participating in a 13-week randomized treatment-control group intervention, with 20 of 50 classified as resilient in losing weight. Measures included the Postpartum Support Scale, the Perceived Stress Scale, and health habit items from the Self Care Inventory. Weight-loss resilient women showed significantly more frequent healthful dietary habits, such as eating a nutritious breakfast, and less frequent unhealthy habits, such as substituting junk food for meals, and less perceived stress than their nonresilient counterparts at both the midpoint and end of the study. Weight-loss resilient women also showed significantly more frequent physical activity habits at the end of the study. No social support differences were found.",2019,"Weight-loss resilient women showed significantly more frequent healthful dietary habits, such as eating a nutritious breakfast, and less frequent unhealthy habits, such as substituting junk food for meals, and less perceived stress than their nonresilient counterparts at both the midpoint and end of the study.","['Participants were low-income postpartum women participating', 'women who lost weight (resilient) and those who did not lose or gained weight (nonresilient) during a weight-loss intervention']",[],"['frequent physical activity habits', 'Postpartum Support Scale, the Perceived Stress Scale, and health habit items from the Self Care Inventory', 'Weight-Loss Resilience']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",[],"[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0222045'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0139034,"Weight-loss resilient women showed significantly more frequent healthful dietary habits, such as eating a nutritious breakfast, and less frequent unhealthy habits, such as substituting junk food for meals, and less perceived stress than their nonresilient counterparts at both the midpoint and end of the study.","[{'ForeName': 'Lorraine O', 'Initials': 'LO', 'LastName': 'Walker', 'Affiliation': 'The University of Texas at Austin, TX, USA.'}, {'ForeName': 'Sookja', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'The University of Texas at Austin, TX, USA.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'S Sterling', 'Affiliation': 'The University of Texas at Austin, TX, USA.'}]",Western journal of nursing research,['10.1177/0193945918824598']
1559,30414164,Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study.,"BACKGROUNDS
The placement of a self-expandable metal stent (SEMS) is widely used in patients with unresectable malignant biliary obstructions, but SEMSs are susceptible to occlusion by tumor ingrowth or overgrowth. The efficacy and safety of a novel paclitaxel-eluting biliary metal stent incorporating sodium caprate (MSCPM-III) were compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions.
METHODS
Patients with unresectable distal malignant biliary obstructions (n = 106) were prospectively enrolled in this study at multiple treatment centers. Stents were placed endoscopically: MSCPM-III in 54 patients and CMS in 51 patients. The patients received systemic chemotherapy regimens according to their disease characteristics.
RESULTS
The two groups did not differ significantly in basic characteristics or mean follow-up period. Stent occlusion occurred in 14 patients who received MSCPM-III and in 11 patients who received CMS. Time to recurrent biliary obstruction (RBO) and survival time did not differ significantly between the two groups ( P = 0.84 and P = 0.29, respectively). However, tumor size at 2 months after stent insertion was significantly decreased in patients in the MSCPM-III group with bile duct cancers or those who experienced stent migration compared with the CMS group. Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups.
CONCLUSIONS
Although compared with a CMS the MSCPM-III did not significantly influence time to RBO or survival duration in patients with malignant biliary obstructions, MSCPM-III reduced tumor volume and was used safely in humans.",2019,"Time to recurrent biliary obstruction (RBO) and survival time did not differ significantly between the two groups ( P = 0.84 and P = 0.29, respectively).","['patients with malignant biliary obstructions', 'malignant biliary obstruction', 'Patients with unresectable distal malignant biliary obstructions (n\u200a=\u200a106', 'patients with unresectable malignant biliary obstructions']","['self-expandable metal stent (SEMS', 'systemic chemotherapy regimens', 'novel paclitaxel-eluting biliary metal stent incorporating sodium caprate (MSCPM-III', 'paclitaxel-eluting biliary metal stent with sodium caprate', 'CMS', 'covered metal stent (CMS']","['time to RBO or survival duration', 'Complications, including cholangitis and pancreatitis', 'Stent occlusion', 'tumor size', 'efficacy and safety', 'Time to recurrent biliary obstruction (RBO) and survival time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]","[{'cui': 'C4042807', 'cui_str': 'Self Expandable Metal Stents'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0441290', 'cui_str': 'Metal stent (physical object)'}, {'cui': 'C0142815', 'cui_str': 'decanoic acid, sodium salt'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008311', 'cui_str': 'Cholangitis'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0919560', 'cui_str': 'Stent occlusion'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",106.0,0.0311059,"Time to recurrent biliary obstruction (RBO) and survival time did not differ significantly between the two groups ( P = 0.84 and P = 0.29, respectively).","[{'ForeName': 'Sung Ill', 'Initials': 'SI', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyu Taek', 'Initials': 'KT', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung Sik', 'Initials': 'JS', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Busan Paik Hospital Inje University College of Medicine, Pusan, South Korea.'}, {'ForeName': 'Seok', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Inha University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Don Haeng', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inha University College of Medicine, Incheon, South Korea.'}, {'ForeName': 'Yong Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Hyub', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jeong-Sik', 'Initials': 'JS', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong Ki', 'Initials': 'DK', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}]",Endoscopy,['10.1055/a-0754-5763']
1560,30658932,"Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial.","BACKGROUND
In the ongoing phase 3, CheckMate 214 trial, nivolumab plus ipilimumab improved overall survival compared with sunitinib in patients with intermediate or poor risk, previously untreated, advanced renal cell carcinoma. We aimed to assess whether health-related quality of life (HRQoL) could be used to further describe the benefit-risk profile of nivolumab plus ipilimumab versus sunitinib.
METHODS
In the phase 3, randomised, controlled, CheckMate 214 trial, patients aged 18 years and older with previously untreated, advanced or metastatic renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries. Patients were categorised by risk status into favourable, intermediate, and poor risk subgroups and randomly assigned (1:1) to open-label nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed by nivolumab 3 mg/kg every 2 weeks, or sunitinib 50 mg/day for 4 weeks of each 6-week cycle. Randomisation was done with a block size of four and stratified by risk status and geographical region. Patient-reported outcomes (PROs) were assessed using the Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19), Functional Assessment of Cancer Therapy-General (FACT-G), and EuroQol five dimensional three level (EQ-5D-3L) instruments. The coprimary endpoints of the trial, reported previously, were overall survival, progression-free survival, and the proportion of patients who had an objective response in those categorised as at intermediate or poor risk. PROs in all randomised participants were assessed as an exploratory endpoint; here we report this exploratory endpoint. This study is registered with ClinicalTrials.gov, number NCT02231749, and is ongoing but is now closed to recruitment.
FINDINGS
Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) were randomly assigned to treatment, of whom 847 (77%) were at intermediate or poor risk and randomly assigned to nivolumab plus ipilimumab (n=425) or sunitinib (n=422). Median follow-up was 25·2 months (IQR 23·0-27·4). PROs were more favourable with nivolumab plus ipilimumab than sunitinib throughout the first 103 weeks after baseline, with mean change from baseline at week 103 for FKSI-19 total score being 4·00 (95% CI 1·91 to 6·09) for nivolumab plus ipilimumab versus -3·14 (-6·03 to -0·25) for sunitinib (p<0·0001), and for FACT-G total score being 4·77 (1·73 to 7·82) for nivolumab plus ipilimumab versus -4·32 (-8·54 to -0·11) for sunitinib (p=0·0005). Significant differences were also seen for four of five FKSI-19 domains (disease-related symptoms, physical disease-related symptoms, treatment side-effects, and functional wellbeing) and FACT-G physical and functional wellbeing domains. However, there was no significant difference between the treatment groups at week 103 in EQ-5D-3L visual analogue rating scale (VAS) scores, with mean change from baseline to week 103 of 10·07 (95% CI 4·35 to 15·80) for nivolumab plus ipilimumab and 6·40 (-1·36 to 14·16) for sunitinib (p=0·45). Compared with sunitinib, nivolumab plus ipilimumab reduced risk of deterioration in FKSI-19 total score (hazard ratio [HR] 0·54; 95% CI 0·46-0·63), FACT-G total score (0·63, 0·52-0·75), and EQ-5D-3L VAS score (HR 0·75, 95% CI 0·63-0·89) and UK utility scores (0·67, 0·57-0·80).
INTERPRETATION
Nivolumab plus ipilimumab leads to fewer symptoms and better HRQoL than sunitinib in patients at intermediate or poor risk with advanced renal cell carcinoma. These results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib comes with the additional benefit of improved HRQoL.
FUNDING
Bristol-Myers Squibb and ONO Pharmaceutical.",2019,"PROs were more favourable with nivolumab plus ipilimumab than sunitinib throughout the first 103 weeks after baseline, with mean change from baseline at week 103 for FKSI-19 total score being 4·00 (95% CI 1·91 to 6·09) for nivolumab plus ipilimumab versus -3·14","['patients with intermediate or poor risk, previously untreated, advanced renal cell carcinoma', 'Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) were randomly assigned to treatment, of whom 847 (77%) were at intermediate or poor risk and randomly assigned to', 'patients aged 18 years and older with previously untreated, advanced or metastatic renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries', 'patients at intermediate or poor risk with advanced renal cell carcinoma', 'patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214']","['sunitinib, nivolumab plus ipilimumab', 'open-label nivolumab 3 mg/kg plus ipilimumab', 'nivolumab plus ipilimumab', 'nivolumab plus ipilimumab (n=425) or sunitinib', 'nivolumab plus ipilimumab versus -4·32']","['overall survival, progression-free survival, and the proportion of patients who had an objective response', 'EQ-5D-3L visual analogue rating scale (VAS) scores', 'UK utility scores', 'EQ-5D-3L VAS score', 'health-related quality of life (HRQoL', 'PROs', 'FACT-G total score', 'Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19), Functional Assessment of Cancer Therapy-General', 'five FKSI-19 domains (disease-related symptoms, physical disease-related symptoms, treatment side-effects, and functional wellbeing) and FACT-G physical and functional wellbeing domains', 'risk of deterioration in FKSI-19 total score', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C4517571', 'cui_str': '1390 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.267083,"PROs were more favourable with nivolumab plus ipilimumab than sunitinib throughout the first 103 weeks after baseline, with mean change from baseline at week 103 for FKSI-19 total score being 4·00 (95% CI 1·91 to 6·09) for nivolumab plus ipilimumab versus -3·14","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, IL, USA. Electronic address: d-cella@northwestern.edu.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Hannover Medical School, Hannover, Lower Saxony, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, London, UK.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic Taussig Cancer Center, Cleveland, OH, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Doan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ivanescu', 'Affiliation': 'IQVIA, Durham, NC, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paty', 'Affiliation': 'IQVIA, Durham, NC, USA.'}, {'ForeName': 'Sabeen', 'Initials': 'S', 'LastName': 'Mekan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30778-2']
1561,31420724,Impact of Intermittent Pringle Maneuver on Long-Term Survival After Hepatectomy for Hepatocellular Carcinoma: Result from Two Combined Randomized Controlled Trials.,"BACKGROUND
Hepatectomy remains an important curative treatment for hepatocellular carcinoma (HCC). Intermittent Pringle maneuver (IPM) is commonly applied during hepatectomy for control of bleeding. Whether the ischemia/reperfusion injury brought by IPM adversely affects the operative outcomes is controversial. This study aims to examine whether the application of IPM during hepatectomy affects the long-term outcomes.
METHODS
Two randomized controlled trials (RCT) have been carried out previously to evaluate the short-term outcomes of IPM. The present study represented a post hoc analysis on the HCC patients from the first RCT and all patients from the second RCT, and the long-term outcomes were evaluated.
RESULTS
There were 88 patients each in the IPM group and the no-Pringle-maneuver (NPM) group. The patient demographics, type and extent of liver resection and histopathological findings were comparable between the two groups. The 1-, 3-, 5-year overall survival in the IPM and NPM groups was 92.0%, 82.0%, 72.1% and 93.2%, 68.8%, 58.1%, respectively (P = 0.030). The 1-, 3-, 5-year disease-free survival in the IPM and NPM groups was 73.6%, 56.2%, 49.7% and 71.6%, 49.4%, 40.3%, respectively (P = 0.366). On multivariable analysis, IPM was a favorable factor for overall survival (P = 0.035). Subgroup analysis showed that a clamp time of 16-30 min (P = 0.024) and cirrhotic patients with IPM (P = 0.009) had better overall survival.
CONCLUSION
IPM provided a better overall survival after hepatectomy for patients with HCC. Such survival benefit was noted in cirrhotic patients, and the beneficial duration of clamp was 16-30 min.
TRIAL REGISTRATION
NCT00730743 and NCT01759901 ( http://www.clinicaltrials.gov ).",2019,"The 1-, 3-, 5-year disease-free survival in the IPM and NPM groups was 73.6%, 56.2%, 49.7% and 71.6%, 49.4%, 40.3%, respectively (P = 0.366).","['88 patients each in the IPM group and the no-Pringle-maneuver (NPM) group', 'patients with HCC', 'Hepatocellular Carcinoma', 'hepatocellular carcinoma (HCC', 'cirrhotic patients']","['Intermittent Pringle maneuver (IPM', 'IPM']","['5-year disease-free survival', 'overall survival', '5-year overall survival', 'Such survival benefit', 'Long-Term Survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",88.0,0.266899,"The 1-, 3-, 5-year disease-free survival in the IPM and NPM groups was 73.6%, 56.2%, 49.7% and 71.6%, 49.4%, 40.3%, respectively (P = 0.366).","[{'ForeName': 'Kit Fai', 'Initials': 'KF', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, 30-32, Ngan Shing Street, Shatin, N.T., Hong Kong SAR, China.'}, {'ForeName': 'Charing C N', 'Initials': 'CCN', 'LastName': 'Chong', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, 30-32, Ngan Shing Street, Shatin, N.T., Hong Kong SAR, China.'}, {'ForeName': 'Sunny Y S', 'Initials': 'SYS', 'LastName': 'Cheung', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, 30-32, Ngan Shing Street, Shatin, N.T., Hong Kong SAR, China.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, 30-32, Ngan Shing Street, Shatin, N.T., Hong Kong SAR, China.'}, {'ForeName': 'Andrew K Y', 'Initials': 'AKY', 'LastName': 'Fung', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, 30-32, Ngan Shing Street, Shatin, N.T., Hong Kong SAR, China.'}, {'ForeName': 'Hon Ting', 'Initials': 'HT', 'LastName': 'Lok', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, 30-32, Ngan Shing Street, Shatin, N.T., Hong Kong SAR, China.'}, {'ForeName': 'Paul B S', 'Initials': 'PBS', 'LastName': 'Lai', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, 30-32, Ngan Shing Street, Shatin, N.T., Hong Kong SAR, China. paullai@surgery.cuhk.edu.hk.'}]",World journal of surgery,['10.1007/s00268-019-05130-8']
1562,31679120,Pharmacokinetics and Bioequivalence Evaluation of a New Oxycodone Tamper-Resistant Tablet Administered with an Opioid Antagonist in Patients with Chronic Pain.,"BACKGROUND AND OBJECTIVES
Oxycodone tamper resistant (OTR) is a new extended-release abuse-deterrent formulation providing improvements in the tamper resistant characteristics. This study aimed to investigate the pharmacokinetic properties of the new OTR tablets and evaluate the bioequivalence of oxycodone from OTR and the original extended release (ER) formulation tablets administered with an opioid antagonist in patients with chronic pain.
METHODS
In this open-label, randomized, cross-over study, the enrolled patients were randomised to receive a single dose of 40 mg OTR or 40 mg OXYCONTIN ® (OXY) tablet administered with naltrexone blockade under fasting conditions. Serial blood samples for pharmacokinetic analysis were collected. Plasma oxycodone was quantified by a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. Tolerability was evaluated by monitoring adverse events, physical examinations, 12-lead ECG and laboratory tests.
RESULTS
A total of 38 patients were enrolled and 33 subjects completed the study. After a single dose of 40 mg tablets, pharmacokinetic results of the new OTR tablet were found to be similar to those of original extended-release oxycodone tablet. OTR 40 mg was bioequivalent to OXY 40 mg and was well tolerated in patients with chronic pain.
CONCLUSIONS
The new OTR formulation could provide a new choice in the treatment of chronic pain and reduce the potential for oxycodone abuse. Chictr.org identifier: ChiCTR1800017253.",2020,"After a single dose of 40 mg tablets, pharmacokinetic results of the new OTR tablet were found to be similar to those of original extended-release oxycodone tablet.","['38 patients were enrolled and 33 subjects completed the study', 'patients with chronic pain', 'Patients with Chronic Pain']","['New Oxycodone Tamper-Resistant Tablet Administered with an Opioid Antagonist', 'opioid antagonist', 'OTR or 40\xa0mg OXYCONTIN ® (OXY) tablet administered with naltrexone blockade under fasting conditions', 'oxycodone', 'Oxycodone tamper resistant (OTR']","['Plasma oxycodone', 'monitoring adverse events, physical examinations, 12-lead ECG and laboratory tests', 'Tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0722364', 'cui_str': 'Oxycontin'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}]",,0.0475192,"After a single dose of 40 mg tablets, pharmacokinetic results of the new OTR tablet were found to be similar to those of original extended-release oxycodone tablet.","[{'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': ""GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': ""GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Shiqing', 'Initials': 'S', 'LastName': 'Shu', 'Affiliation': ""GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China. 641855044@qq.com.""}]",Clinical drug investigation,['10.1007/s40261-019-00870-w']
1563,31680502,GlideScope® versus Macintosh laryngoscope for assessment of post-thyroidectomy vocal cord dysfunction: prospective randomized study.,"BACKGROUND
Early detection of post-thyroidectomy vocal cord dysfunction is crucial. This study compared GlideScope® with Macintosh direct laryngoscope (MDL) regarding the accuracy of assessment of post-thyroidectomy vocal cord dysfunction.
METHODS
One hundred and twenty patients scheduled for elective thyroidectomy, aged 18 - 50 years, of either sex were enrolled in the study. Standard general anesthesia technique was used in all patients. At the end of operation, patients were randomly allocated into one of the following sequences: 1) examined with MDL then GlideScope®, or 2) examined with GlideScope® then MDL. Postoperative tele-laryngoscopic examination was done after 12 hours. The primary outcome of the study was the sensitivity and the specificity of GlideScope® to detect vocal cord dysfunction while the secondary outcomes were the Cormack-Lehane grade of the glottis visualization and the incidence of complications.
RESULTS
The incidence of vocal cord dysfunction was 15 (12.5%); all cases were unilateral. The GlideScope® was more sensitive (86.7%) and specific (95.2%) with higher diagnostic accuracy (94.2%) for detecting vocal cord dysfunction than MDL. There was a high agreement between the GlideScope® findings and the final diagnosis (kappa 0.754 [95% CI: 0.581-0.928]). Cormack-Lehane score was significantly better by the GlideScope® than by the MDL (P<0.001). The incidence of hoarseness of voice was 32 (26.7%) with eight cases among the diagnosed patients. No cases of aspiration or stridor were recorded.
CONCLUSIONS
This study demonstrates that GlideScope® is a better alternative to MDL for an accurate detection of post-thyroidectomy vocal cord dysfunction.",2020,Cormack-Lehane score was significantly better by the Glidescope® than by the MDL (p-value <0.001).,"['One hundred and twenty patients scheduled for elective thyroidectomy, aged 18 - 50 years, of either sex were enrolled in the study', 'post-thyroidectomy vocal cord dysfunction']","['GlideScope® versus Macintosh laryngoscope', 'GlideScope®', 'GlideScope® with Macintosh direct laryngoscope (MDL']","['incidence of vocal cord dysfunction', 'sensitivity and the specificity of GlideScope® to detect vocal cord dysfunction', 'Postoperative tele- laryngoscopic examination', 'aspiration or stridor', 'diagnostic accuracy', 'Cormack-Lehane score', 'incidence of hoarseness of voice', 'Cormack-Lehane grade of the glottis visualization and the incidence of complications']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0859897', 'cui_str': 'Paradoxical Vocal Fold Motion Disorder'}]","[{'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0859897', 'cui_str': 'Paradoxical Vocal Fold Motion Disorder'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0038450', 'cui_str': 'Stridor'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",120.0,0.0414484,Cormack-Lehane score was significantly better by the Glidescope® than by the MDL (p-value <0.001).,"[{'ForeName': 'Marwa A', 'Initials': 'MA', 'LastName': 'Elbeialy', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt - mar_khairy@yahoo.com.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Maarouf', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alansary', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Minerva anestesiologica,['10.23736/S0375-9393.19.14043-6']
1564,31655054,"Use of a novel index, the A-index, and its associated nomogram to predict overall survival rates after resection of primary hepatocellular carcinoma.","BACKGROUND
Several international staging or scoring systems don't accurately predict overall survival (OS) after resection of primary hepatocellular carcinoma (PHCC). Therefore, we attempted to overcome this limitation by constructing the A-index and its associated nomogram.
METHODS
We selected 672 patients who underwent curative resection of PHCC between January 2007 and February 2015 at the first affiliated hospital of the Wenzhou medical university. These subjects were randomly divided into the training (n = 470) and the validation group (n = 202) according to the ratio of 7:3.
RESULTS
We prepared the nomogram using eight independent risk factors including the A-index (calculated by 100 × aspartate transaminase /albumin /albumin) in the training cohort. The concordance index (C-index) of the nomogram for both training and validation set was similar in indicating the OS rate. The nomogram showed the strongest predictive power for the 1-year, 3-year, and 5-year OS, with the area under the ROC curve being 0.8182, 0.7892, and 0.7669, respectively. Correction curves showed consistent performance for both groups, stratification of the Kaplan-Meier curve was significant (P < 0.001), and decision curve analysis (DCA) showed the superiority of nomograms considering clinical effects.
CONCLUSIONS
The predictive power of the nomogram integrating the A-index for OS was optimal.",2020,"The nomogram showed the strongest predictive power for the 1-year, 3-year, and 5-year OS, with the area under the ROC curve being 0.8182, 0.7892, and 0.7669, respectively.","['primary hepatocellular carcinoma (PHCC', '672 patients who underwent curative resection of PHCC between January 2007 and February 2015 at the first affiliated hospital of the Wenzhou medical university']",[],"['concordance index (C-index', '1-year, 3-year, and 5-year OS', 'overall survival rates']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",672.0,0.0350993,"The nomogram showed the strongest predictive power for the 1-year, 3-year, and 5-year OS, with the area under the ROC curve being 0.8182, 0.7892, and 0.7669, respectively.","[{'ForeName': 'Bin-Bin', 'Initials': 'BB', 'LastName': 'Cai', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China; Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Xiang-Qing', 'Initials': 'XQ', 'LastName': 'Hou', 'Affiliation': 'Wenzhou Medical University, Wenzhou, Zhejiang, China; Department of Preventive Medicine, School of Public Health and Management, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Diagnosis and Treatment of Severe Hepato-Pancreatic Diseases of Zhejiang Province, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Ye', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Guan', 'Initials': 'G', 'LastName': 'Fang', 'Affiliation': 'Department of Colorectal Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Han-Zhang', 'Initials': 'HZ', 'LastName': 'Huang', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Bao', 'Affiliation': 'Central Laboratory, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China; Wenzhou Medical University, Wenzhou, Zhejiang, China. Electronic address: wwm_boy2010@163.com.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2019.10.001']
1565,30472141,Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials.,"PURPOSE
The intranasal tear neurostimulator (ITN) activates the nasolacrimal pathway, which is involved with basal and bolus tear secretion. These studies characterized the acute and long-term effectiveness of the ITN in stimulating tear production in subjects with dry eye disease (DED).
METHODS
Study 1: Randomized, double-masked, dual-controlled, 1-day crossover. Study 2: Single-arm, open-label, 180-day prospective cohort. Eligible subjects had basal unstimulated Schirmer test (with anesthesia) ≤10 mm and intranasal cotton swab-stimulated Schirmer test at least 7 mm greater in the same eye, and Ocular Surface Disease Index ® ≥13 and ≥ 23, in Studies 1 and 2, respectively. Study 1: Subjects (n = 48) received three randomized test applications: active intranasal, extranasal (active control), and sham intranasal (inactive control) stimulation, 3 min/application with 1-hour minimum between applications. Primary outcome measure was the difference in Schirmer test scores during active intranasal and control applications. Study 2: Subjects (n = 97) performed intranasal neurostimulation for ≤3 min/application, 2-10 times/day. Primary outcome measure was the difference in Schirmer scores (stimulated minus unstimulated) at day 180. Both studies recorded device-related adverse events (AEs).
RESULTS
Study 1: Schirmer scores (mean ± SEM) were significantly greater (p < 0.0001) with active intranasal (25.3 ± 1.5 mm) vs extranasal (9.5 ± 1.2 mm) and sham (9.2 ± 1.1 mm) applications. Study 2: Schirmer scores were significantly greater (p < 0.0001) with ITN stimulation vs unstimulated at day 180 (17.3 ± 1.3 mm vs 7.9 ± 0.7 mm). No serious device-related AEs were reported in either study.
CONCLUSION
The ITN was well-tolerated and effective in stimulating tear production with acute and long-term use in DED. CLINICALTRIALS.
GOV IDENTIFIER
NCT02680158 and NCT02526290.",2019,Schirmer scores were significantly greater (p < 0.0001) with ITN stimulation vs unstimulated at day 180 (17.3 ± 1.3 mm vs 7.9 ± 0.7 mm).,"['subjects with dry eye disease during intranasal tear neurostimulation', 'subjects with dry eye disease (DED', 'Eligible subjects had basal unstimulated Schirmer test (with anesthesia) ≤10\u202fmm and intranasal cotton', 'Study 1: Subjects (n\u202f=\u202f48', 'Study 2: Subjects (n\u202f=\u202f97) performed']","['intranasal neurostimulation', 'intranasal tear neurostimulator (ITN', 'ITN', 'active intranasal, extranasal (active control), and sham intranasal (inactive control) stimulation, 3\u202fmin/application with 1-hour minimum between applications']","['Schirmer scores', 'Schirmer scores (mean\u202f±\u202fSEM', 'Schirmer test scores']","[{'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated (qualifier value)'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1095832', 'cui_str': 'Cotton - textile'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0582124', 'cui_str': 'Neurostimulator, device (physical object)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}]",,0.144025,Schirmer scores were significantly greater (p < 0.0001) with ITN stimulation vs unstimulated at day 180 (17.3 ± 1.3 mm vs 7.9 ± 0.7 mm).,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sheppard', 'Affiliation': 'Virginia Eye Consultants and Eastern Virginia Medical School, Norfolk, VA, USA. Electronic address: docshep@hotmail.com.'}, {'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Torkildsen', 'Affiliation': 'Andover Eye Associates, Andover, MA, USA.'}, {'ForeName': 'Joel A', 'Initials': 'JA', 'LastName': 'Geffin', 'Affiliation': 'The Eye Care Group, Waterbury, CT, USA.'}, {'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'Dao', 'Affiliation': 'Cornea and Cataract Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Evans', 'Affiliation': 'Total Eye Care, Memphis, TN, USA.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Ousler', 'Affiliation': 'Ora, Inc., Andover, MA, USA.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Allergan plc, South San Francisco, CA, USA.'}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Baba', 'Affiliation': 'Allergan plc, South San Francisco, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Senchyna', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Holland', 'Affiliation': 'Cincinnati Eye Institute and the University of Cincinnati, Cincinnati, OH, USA.'}]",The ocular surface,['10.1016/j.jtos.2018.11.009']
1566,28356841,"Effect of Nutritionally Relevant Doses of Long-Chain N-3 Pufa on Lipid Status, Oxidative Stress and Inflammatory Markers in an Average Middle-Aged Serbian Population.","BACKGROUND
This study investigated the effects of a nutritionally relevant intake of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids derived from oily fish or a fish oil supplement on selected cardiovascular risk factors in average middle-aged individuals.
METHODS
Thirty-three participants were randomized to receive salmon (oily fish) providing 274 mg EPA + 671 mg DHA/day or a commercial fish oil supplement providing 396 mg EPA + 250 mg DHA/day in a cross-over trial over an 8-week period separated by a 6-month washout period. Blood samples were collected before and after each intervention and lipids, inflammatory and oxidative stress parameters were determined.
RESULTS
Plasma levels of EPA, DHA and total n-3 fatty acids significantly increased after both interventions. A decreasing trend in triglycerides was more pronounced with salmon than with the fish oil supplement, but the changes noticed were not significant. Although there were no relevant changes in inflammatory marker concentrations at the end of both interventions, significant negative correlations were noticed between total plasma n-3 fatty acids and soluble intercellular adhesion molecule and C-reactive protein throughout the whole intervention period (p<0.05). Among the oxidative stress parameters, intervention with salmon showed a prooxidative effect through a superoxide anion increase (p=0.025). A relevant positive correlation was also found between its concentration and total plasma n-3 fatty acids (p<0.05). Other oxidative stress markers were not significantly influenced by the dietary interventions applied.
CONCLUSIONS
Following two sets of recommendations for n-3 fatty acids intake aimed at the general public had only a moderate effect on the selected cardiovascular risk factors in average healthy middle-aged subjects over a short-term period.",2015,"Among the oxidative stress parameters, intervention with salmon showed a prooxidative effect through a superoxide anion increase (p=0.025).","['average middle-aged individuals', 'average healthy middle-aged subjects', 'Average Middle-Aged Serbian Population', 'Thirty-three participants']","['salmon (oily fish) providing 274 mg EPA + 671 mg DHA/day or a commercial fish oil supplement providing 396 mg EPA + 250 mg DHA', 'n-3 fatty acids intake', 'eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids', 'Nutritionally Relevant Doses of Long-Chain N-3 Pufa']","['triglycerides', 'Lipid Status, Oxidative Stress and Inflammatory Markers', 'Plasma levels of EPA, DHA and total n-3 fatty acids', 'oxidative stress markers', 'cardiovascular risk factors', 'total plasma n-3 fatty acids and soluble intercellular adhesion molecule and C-reactive protein', 'concentration and total plasma n-3 fatty acids', 'inflammatory marker concentrations']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}]","[{'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish (substance)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0556124', 'cui_str': 'N-3 fatty acid intake (observable entity)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",33.0,0.0712665,"Among the oxidative stress parameters, intervention with salmon showed a prooxidative effect through a superoxide anion increase (p=0.025).","[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Đuričić', 'Affiliation': 'Department of Bromatology, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Kotur-Stevuljević', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Miljković', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Kerkez', 'Affiliation': 'Clinic for Digestive Surgery - 1st Surgical Clinic, Clinical Center of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Đorđević', 'Affiliation': 'Clinic for Digestive Surgery - 1st Surgical Clinic, Clinical Center of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Ljubomir', 'Initials': 'L', 'LastName': 'Đurašić', 'Affiliation': 'Clinic for Physical Medicine and Rehabilitation, Clinical Center of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Slađana', 'Initials': 'S', 'LastName': 'Šobajić', 'Affiliation': 'Department of Bromatology, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.'}]",Journal of medical biochemistry,['10.2478/jomb-2014-0039']
1567,31889572,Effect of Gum Chewing on Pain and Anxiety in Turkish Children During Intravenous Cannulation: A Randomized Controlled Study.,"PURPOSE
Although gum chewing is a simple intervention that can be used for the management of pain and anxiety in the nursing care of children, few studies have assessed this intervention. This study aimed to investigate the effect of gum chewing on pain and anxiety during intravenous (IV) cannulation in children.
DESIGN AND METHODS
This randomized controlled study assessed 73 children aged 6 to 12 years in the general paediatric unit in a university hospital in the Trachy Region, Turkey from April to September 2017. In the experimental group, children chewed gum during the procedure. The standard care was applied to the control group. Data were collected via the Children's Anxiety Pain Scale and the Data Collection Form.
RESULTS
According to the children's self-report and the nurse's report, the pain level of the experimental group was significantly lower than the control group. Although no significant difference was noted between experimental and control groups' anxiety levels, nurses stated higher anxiety levels than children.
CONCLUSIONS
The IV cannulation procedure causes pain and anxiety in children. Nurses reported the perception of a higher level of anxiety during the procedure than the children actually experienced. Gum chewing might reduce pain during IV cannulation. Nurses should consider using gum chewing as a simple nursing implementation to increase the effects of other pharmacological and non-pharmacological techniques for management of children's procedural pain.
PRACTICE IMPLICATIONS
Nurses who work with the children could use gum chewing as a simple, inexpensive, and pleasurable intervention for the management of pain.",2020,"Although no significant difference was noted between experimental and control groups' anxiety levels, nurses stated higher anxiety levels than children.
","['Turkish children during intravenous cannulation', '73 children aged 6 to 12\xa0years in the general paediatric unit in a university hospital in the Trachy Region, Turkey from April to September 2017', 'children']","['Gum chewing', 'intravenous (IV) cannulation', 'gum chewing']","['Anxiety Pain Scale', 'pain level', 'pain', 'anxiety levels', 'pain and anxiety', 'level of anxiety']","[{'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0398266', 'cui_str': 'Introduction of catheter into vein'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0040591', 'cui_str': 'Tracheotomy'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0398266', 'cui_str': 'Introduction of catheter into vein'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",73.0,0.0267307,"Although no significant difference was noted between experimental and control groups' anxiety levels, nurses stated higher anxiety levels than children.
","[{'ForeName': 'Sacide', 'Initials': 'S', 'LastName': 'Yildizeli Topcu', 'Affiliation': 'Trakya University, Faculty of Health Sciences, Department of Surgical Nursing, Edirne, Turkey. Electronic address: sacideyildizeli@trakya.edu.tr.'}, {'ForeName': 'Melahat', 'Initials': 'M', 'LastName': 'Akgun Kostak', 'Affiliation': 'Trakya University, Faculty of Health Sciences, Department of Child Health and Disease Nursing, Edirne, Turkey.'}, {'ForeName': 'Remziye', 'Initials': 'R', 'LastName': 'Semerci', 'Affiliation': 'Trakya University, Faculty of Health Sciences, Department of Child Health and Disease Nursing, Edirne, Turkey.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Guray', 'Affiliation': 'Trakya University, Health Practice and Research Center, Pediatric Surgery Service, Edirne, Turkey.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2019.12.007']
1568,30524185,Efficacy of a New Crosslinked Hyaluronan Gel in the Prevention of Intrauterine Adhesions.,"Background and Objectives
The authors sought to assess the effect of the use of a new crosslinked hyaluronan (NCH) gel on the prevention of intrauterine adhesions (IUAs) in women underwent curettage in the second trimester.
Methods
Between June 2016 and September 2017, 60 patients who underwent curettage for retained placental tissue after medically induced or spontaneous pregnancy loss in the second trimester were enrolled in the study. The patients were randomly assigned to 1 of 2 groups: Group 1 patients received curettage plus NCH gel (intervention group), and group 2 patients received curettage alone (control group). The main outcomes were the rate and severity of IUA formation, which were assessed by follow-up hysteroscopy performed in the ensuing 2-6 months.
Results
The hysteroscopic findings were available for 20 patients in group 1 and 28 patients in group 2. IUAs were observed in 6 patients in group 2, while no IUAs was observed in group 1 ( P = .007). IUAs were staged as mild in 4 patients (14.28%) and moderate in 2 patients (7.14%) in group 2 according to the American Fertility Society classification of IUAs.
Conclusions
Our study demonstrates that NCH gel appears to be able to reduce the formation of IUAs in women who undergo curettage in the second trimester, although larger controlled, randomized, multicenter studies are needed to confirm these results.",2018,"IUAs were observed in 6 patients in group 2, while no IUAs was observed in group 1 ( P = .007).","['Methods\n\n\nBetween June 2016 and September 2017, 60 patients who underwent curettage for retained placental tissue after medically induced or spontaneous pregnancy loss in the second trimester were enrolled in the study', 'women underwent curettage in the second trimester', 'women who undergo curettage in the second trimester']","['new crosslinked hyaluronan (NCH) gel', 'New Crosslinked Hyaluronan Gel', 'curettage alone (control group', 'curettage plus NCH gel', 'NCH gel']","['Intrauterine Adhesions', 'rate and severity of IUA formation', 'intrauterine adhesions (IUAs', 'IUAs', 'formation of IUAs']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0694695', 'cui_str': 'Tissue specimen from placenta'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0032980', 'cui_str': 'Midtrimester'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0813622', 'cui_str': 'Hyaluronan'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1704274', 'cui_str': 'Intrauterine adhesions (disorder)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",,0.0320014,"IUAs were observed in 6 patients in group 2, while no IUAs was observed in group 1 ( P = .007).","[{'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Can', 'Affiliation': 'School of Medicine, Istanbul University, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Kirpinar', 'Affiliation': 'School of Medicine, Istanbul University, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Dural', 'Affiliation': 'School of Medicine, Istanbul University, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Burcin Balci', 'Initials': 'BB', 'LastName': 'Karamustafaoglu', 'Affiliation': 'School of Medicine, Istanbul University, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Inci Sema', 'Initials': 'IS', 'LastName': 'Tas', 'Affiliation': 'School of Medicine, Istanbul University, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Yasa', 'Affiliation': 'School of Medicine, Istanbul University, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}, {'ForeName': 'Funda Gungor', 'Initials': 'FG', 'LastName': 'Ugurlucan', 'Affiliation': 'School of Medicine, Istanbul University, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2018.00036']
1569,30637862,Brain Activity and Clinical Outcomes in Adults With Depression Treated With Synchronized Transcranial Magnetic Stimulation: An Exploratory Study.,"BACKGROUND
Synchronized transcranial magnetic stimulation (sTMS) imparts low-amplitude magnetic stimulation matched to each patient's individual alpha frequency. It may act through entrainment of brain oscillations.
OBJECTIVES
To explore sTMS effects on neurophysiology with electroencephalography (EEG) in adults with major depressive disorder.
METHODS
As an ancillary study to a clinical trial of sTMS, EEGs were recorded at baseline and at one and six weeks of treatment. Associations between EEG measures and clinical symptoms were examined.
RESULTS
Absolute and relative power measures did not differ significantly between active and sham groups and did not change significantly over time. Changes occurring over six weeks in alpha current source density at anterior and central midline voxels were significantly correlated with changes in symptoms in subjects treated with active but not sham sTMS.
CONCLUSION
Neurophysiologic measures suggest that active but not sham sTMS engages brain targets, and that target engagement is related to treatment outcome.",2019,"Changes occurring over six weeks in alpha current source density at anterior and central midline voxels were significantly correlated with changes in symptoms in subjects treated with active but not sham sTMS.
","['Adults With Depression', 'adults with major depressive disorder']","['neurophysiology with electroencephalography (EEG', 'Synchronized transcranial magnetic stimulation (sTMS', 'Synchronized Transcranial Magnetic Stimulation']",['Brain Activity and Clinical Outcomes'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.0437791,"Changes occurring over six weeks in alpha current source density at anterior and central midline voxels were significantly correlated with changes in symptoms in subjects treated with active but not sham sTMS.
","[{'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Cook', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Wilson', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Corlier', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Leuchter', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.12914']
1570,30553932,Incremental clinical effectiveness and cost effectiveness of providing supervised physiotherapy in addition to usual medical care in patients with osteoarthritis of the hip or knee: 2-year results of the MOA randomised controlled trial.,"OBJECTIVE
To investigate the clinical- and cost-effectiveness at 2-year follow-up of providing individual, supervised exercise physiotherapy and/or manual physiotherapy in addition to usual medical care.
METHOD
People with hip or knee osteoarthritis meeting the American College of Rheumatology clinical diagnostic criteria were randomised (1:1, concealed, assessor-blinded) to four groups: usual medical care; supervised exercise physiotherapy; manual physiotherapy; or combined exercise and manual physiotherapy. Physiotherapy group participants were provided 10 50-min treatment sessions including booster sessions at 4 and 13 months, in addition to usual care. The primary outcome at 2-year follow-up was incremental cost-utility ratio (ICUR) of each physiotherapy intervention in addition to usual care, compared with usual care alone, from the health system and societal perspectives. To allow interpretation of negative ICURs, we report incremental net benefit (INB). The primary clinical outcome was the Western Ontario and McMaster Osteoarthritis Index (WOMAC).
RESULTS
Of 206 patients, 186 (90·3%) were retained at 2-year follow-up. Exercise physiotherapy and manual physiotherapy dominated usual care, demonstrating cost savings; combined therapy did not. Exercise therapy had the highest incremental net benefits (INBs), statistically significant at all willingness-to-pay (base-case: societal New Zealand (NZ)$6,312, 95%CI 334 to 12,279; health system NZ$8,065, 95%CI 136 to 15,994). Clinical improvements were superior to usual care only in the exercise physiotherapy group (-28.2 WOMAC points, 95%CI -49.2 to -7.1). No serious adverse events were recorded.
CONCLUSION
Individually supervised exercise therapy is cost-effective and clinically effective in addition to usual medical care at 2-year follow-up, and leads to cost savings for the health system and society.
TRIAL REGISTRATION
Prospectively registered with the Australian NZ Clinical Trials Registry, reference ACTRN12608000130369.",2019,"Clinical improvements were superior to usual care only in the exercise physiotherapy group (-28.2 WOMAC points, 95%CI -49.2 to -7.1).","['People with hip or knee osteoarthritis meeting the American College of Rheumatology clinical diagnostic criteria', 'Of 206 patients, 186 (90·3%) were retained at 2-year follow-up', 'patients with osteoarthritis of the hip or knee']","['usual medical care; supervised exercise physiotherapy; manual physiotherapy; or combined exercise and manual physiotherapy', 'supervised exercise therapy', 'Exercise physiotherapy and manual physiotherapy dominated usual care', 'exercise physiotherapy and/or manual physiotherapy', 'supervised physiotherapy', 'Exercise therapy']","['serious adverse events', 'Incremental clinical effectiveness and cost effectiveness', '2-year follow-up was incremental cost-utility ratio (ICUR) of each physiotherapy intervention in addition to usual care, compared with usual care alone, from the health system and societal perspectives', 'Western Ontario and McMaster Osteoarthritis Index (WOMAC']","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.113474,"Clinical improvements were superior to usual care only in the exercise physiotherapy group (-28.2 WOMAC points, 95%CI -49.2 to -7.1).","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, 9054, New Zealand. Electronic address: haxby.abbott@otago.ac.nz.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, 9054, New Zealand. Electronic address: ross.wilson@otago.ac.nz.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'College of Health Sciences, Program in Physical Therapy, Marquette University, Milwaukee, WI, USA. Electronic address: d.pinto@marquette.edu.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Chapple', 'Affiliation': 'Centre for Health Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, 9054, New Zealand. Electronic address: cathy.chapple@otago.ac.nz.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Wright', 'Affiliation': 'Department of Physical Therapy, High Point University, High Point, NC, USA. Electronic address: awright@highpoint.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Osteoarthritis and cartilage,['10.1016/j.joca.2018.12.004']
1571,31673627,"A 2-yr, School-Based Resistance Exercise Pilot Program Increases Bone Accrual in Adolescent Girls.","Purpose
The current analysis evaluates cumulative benefits after year two (Y2) of a school-based resistance training intervention.
Methods
Adolescent girls were enrolled and measured at the beginning of 6 th grade (baseline, BL) and again at 1 st follow-up (FU1: Y1 end) and 2 nd follow-up (FU2: Y2 end). School gym classes met alternate school days. Site 1 had standard gym classes (CON). Site 2 gym classes included 8-12 minutes of resistance training (INT); INT girls were categorized based on observed participation effort and time (LO, HI). Measurements included: 1) height and weight; 2) questionnaires to assess extracurricular exercise and diet (calcium, vitamin D); 3) dual-energy X-ray absorptiometry (DXA, Lunar Prodigy). Whole body less head (SUB) scans yielded bone mineral content (BMC) and body composition. Lumbar spine (L1-L4) and femoral neck (FN) scans yielded BMC and areal bone mineral density (BMD); radius scans yielded ultradistal and 1/3 BMD. ANCOVA compared group means for percent gains from BL to FU2, accounting for biological maturity, BL height, height change, inter-scan interval, organized activity, calcium and vitamin D.
Results
In 62 girls (21 CON, 41 INT), intention to treat analyses detected INT vs. CON advantages for L1-L4 BMC and BMD (4.1%, 5.6%: p<0.05). HI effort participants (n=19) demonstrated advantages for BMC and BMD at L1-L4 and FN (5.7% to 8.2%, p<0.01) vs. CON.
Conclusions
Over two school years, this resistance intervention yielded lumbar spine advantages; enthusiastic participation (HI) yielded lumbar spine and femoral neck advantages. Further work is warranted to evaluate benefit persistence after intervention cessation.",2019,"In 62 girls (21 CON, 41 INT), intention to treat analyses detected INT vs. CON advantages for L1-L4 BMC and BMD (4.1%, 5.6%: p<0.05).","['Adolescent Girls', 'Methods\n\n\nAdolescent girls were enrolled and measured at the beginning of 6 th grade (baseline, BL) and again at 1 st follow-up (FU1: Y1 end) and 2 nd follow-up']","['School-Based Resistance Exercise Pilot Program', 'FU2', 'school-based resistance training intervention']","['bone mineral content (BMC) and body composition', 'Lumbar spine (L1-L4) and femoral neck (FN) scans yielded BMC and areal bone mineral density (BMD', ' 1) height and weight; 2) questionnaires to assess extracurricular exercise and diet (calcium, vitamin D); 3) dual-energy X-ray absorptiometry (DXA, Lunar Prodigy', 'advantages for BMC and BMD at L1-L4 and FN', 'biological maturity, BL height, height change, inter-scan interval, organized activity, calcium and vitamin D.\nResults']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0441633'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0388929', 'cui_str': 'Prodigy'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",62.0,0.0252131,"In 62 girls (21 CON, 41 INT), intention to treat analyses detected INT vs. CON advantages for L1-L4 BMC and BMD (4.1%, 5.6%: p<0.05).","[{'ForeName': 'Jodi N', 'Initials': 'JN', 'LastName': 'Dowthwaite', 'Affiliation': 'Department of Orthopedic Surgery, SUNY Upstate Medical University, Syracuse, N.Y.'}, {'ForeName': 'Deena M', 'Initials': 'DM', 'LastName': 'Weiss', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health (UWSMPH), Madison, WI.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Thein-Nissenbaum', 'Affiliation': 'Department of Family Medicine and Community Health, UWSMPH, Madison, WI.'}, {'ForeName': 'Tamara A', 'Initials': 'TA', 'LastName': 'Scerpella', 'Affiliation': 'Department of Orthopedic Surgery, SUNY Upstate Medical University, Syracuse, N.Y.'}]",Translational journal of the American College of Sports Medicine,[]
1572,28494656,In-Service Training for Increasing Teachers' ADHD Knowledge and Self-Efficacy.,"OBJECTIVE
The aim of this article is to evaluate the efficacy of a brief in-service training workshop at increasing primary school teachers' ADHD knowledge and sense of self-efficacy.
METHOD
Teachers from 10 schools participated in the study ( n = 274) and were allocated into either an intervention or waitlist control group. Teachers' ADHD knowledge and self-efficacy were assessed following the provision of a brief training workshop on ADHD. Knowledge and self-efficacy retention were also assessed at a 1-month follow-up.
RESULTS
Within the intervention group, ADHD knowledge and self-efficacy increased following the intervention (both ps < .001). Knowledge increased more than twofold, from very low to high levels, although increases in self-efficacy were more modest. Both knowledge and self-efficacy decreased at the 1-month follow-up but, nevertheless, remained higher than baseline levels ( p < .001).
CONCLUSION
Results demonstrate that a brief training workshop can increase primary school teachers' ADHD knowledge and self-efficacy. Whilst increases in self-efficacy were modest, our findings suggest that a brief professional development intervention can be utilized to greatly increase teachers' ADHD knowledge, providing a cost-effective, practical solution to address this well-evidenced gap in teachers' training and knowledge about the disorder.",2019,"Within the intervention group, ADHD knowledge and self-efficacy increased following the intervention (both ps < .001).",['Teachers from 10 schools participated in the study ( n = 274'],"['service training workshop', 'intervention or waitlist control group']","['ADHD knowledge and self-efficacy', 'Knowledge and self-efficacy retention', 'knowledge and self-efficacy', ""primary school teachers' ADHD knowledge and self-efficacy"", ""Teachers' ADHD knowledge and self-efficacy"", 'self-efficacy']","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]",274.0,0.011936,"Within the intervention group, ADHD knowledge and self-efficacy increased following the intervention (both ps < .001).","[{'ForeName': 'Alexandre Pascal', 'Initials': 'AP', 'LastName': 'Latouche', 'Affiliation': '1 School of Psychological Sciences, Australian College of Applied Psychology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gascoigne', 'Affiliation': '1 School of Psychological Sciences, Australian College of Applied Psychology, Sydney, New South Wales, Australia.'}]",Journal of attention disorders,['10.1177/1087054717707045']
1573,26543456,"Articaine and mepivacaine buccal infiltration in securing mandibular first molar pulp anesthesia following mepivacaine inferior alveolar nerve block: A randomized, double-blind crossover study.","AIMS
A crossover double-blind, randomized study was designed to explore the efficacy of 2% mepivacaine with 1:100,000 adrenaline buccal infiltration and 4% articaine with 1:100,000 adrenaline buccal infiltration following 2% mepivacaine with 1:100,000 adrenaline inferior alveolar nerve block (IANB) for testing pulp anesthesia of mandibular first molar teeth in adult volunteers.
MATERIALS AND METHODS
A total of 23 healthy adult volunteers received two regimens with at least 1-week apart; one with 4% articaine buccal infiltration and 2% mepivacaine IANB (articaine regimen) and another with 2% mepivacaine buccal infiltration supplemented to 2% mepivacaine IANB (mepivacaine regimen). Pulp testing of first molar tooth was electronically measured twice at baseline, then at intervals of 2 min for the first 10 min, then every 5 min until 45 min postinjection. Anesthetic success was considered when two consecutive maximal stimulation on pulp testing readings without sensation were obtained within 10 min and continuously sustained for 45 min postinjection.
RESULTS
In total, the number of no sensations to maximum pulp testing for first molar teeth were significantly higher after articaine regimen than mepivacaine during 45 min postinjection (267 vs. 250 episodes, respectively, P < 0.001), however, both articaine and mepivacaine buccal infiltrations are equally effective in securing anesthetic success for first molar pulp anesthesia when supplemented to mepivacaine IANB injections (P > 0.05). Interestingly, volunteers in the articaine regimen provided faster onset and longer duration (means 2.78 min, 42.22 min, respectively) than mepivacaine regimen (means 4.26 min, 40.74 min, respectively) for first molar pulp anesthesia (P < 0.001).
CONCLUSIONS
Supplementary mepivacaine and articaine buccal infiltrations produced similar successful first molar pulp anesthesia following mepivacaine IANB injections in volunteers. Articaine buccal infiltration produced faster onset and longer duration than mepivacaine buccal infiltration following mepivacaine IANB injections.",2015,Supplementary mepivacaine and articaine buccal infiltrations produced similar successful first molar pulp anesthesia following mepivacaine IANB injections in volunteers.,"['volunteers', 'securing mandibular first molar pulp anesthesia following mepivacaine inferior alveolar nerve block', '23 healthy adult volunteers', 'testing pulp anesthesia of mandibular first molar teeth in adult volunteers']","['mepivacaine IANB', 'mepivacaine IANB injections', 'articaine', 'mepivacaine buccal infiltration', 'mepivacaine IANB (articaine', 'mepivacaine IANB (mepivacaine', 'mepivacaine', 'articaine buccal infiltration and 2', 'mepivacaine with 1:100,000 adrenaline inferior alveolar nerve block (IANB', 'Articaine']","['successful first molar pulp anesthesia', 'number of no sensations to maximum pulp testing for first molar teeth', 'faster onset and longer duration', 'anesthetic success']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block (procedure)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block (procedure)'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}]",23.0,0.13281,Supplementary mepivacaine and articaine buccal infiltrations produced similar successful first molar pulp anesthesia following mepivacaine IANB injections in volunteers.,"[{'ForeName': 'Giath', 'Initials': 'G', 'LastName': 'Gazal', 'Affiliation': 'Department of Oral and Maxillofacial, College of Dentistry, Taibah University, Medina, Saudi Arabia.'}, {'ForeName': 'Abdullah Muteb', 'Initials': 'AM', 'LastName': 'Alharbi', 'Affiliation': 'Department of Oral and Maxillofacial, College of Dentistry, Taibah University, Medina, Saudi Arabia.'}, {'ForeName': 'Khalid HidayatAllah', 'Initials': 'KH', 'LastName': 'Al-Samadani', 'Affiliation': 'Department of Restorative Dentistry, College of Dentistry, Taibah University, Medina, Saudi Arabia.'}, {'ForeName': 'Mohammad Dib', 'Initials': 'MD', 'LastName': 'Kanaa', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Kettering General Hospital, Kettering, NN16 8UZ, United Kingdom.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159463']
1574,30604184,Effects of methamphetamine on neural responses to visual stimuli.,"RATIONALE
The behavioral and reward-related effects of stimulant drugs have been studied extensively; yet the effect of stimulants on sensory processing is still relatively unknown. Prior brain imaging studies have shown that single doses of stimulant drugs increase neural function during cognitive and attentional processes. However, it is not clear if stimulant drugs such as methamphetamine (MA) affect neural responses to novel sensory stimuli, and whether these effects depend on the visual features of the stimuli.
OBJECTIVE
In this study, we examined the effects of a single dose of MA (20 mg oral) on neural activation in response to visual stimuli that varied on ""non-straight edges"" (NSE), a low-level visual feature that quantifies curved/fragmented edges and is related to perceived image complexity.
METHODS
Healthy adult participants (n = 18) completed two sessions in which they received MA and placebo in counterbalanced order before an fMRI scan where they viewed both high and low NSE images. Participants also completed measures of subjective drug effects throughout both sessions.
RESULTS
During both sessions, high NSE images activated primary visual cortex to a greater extent than low NSE images. Further, MA increased activation only for low NSE images in three areas of visual association cortex: left fusiform, right cingulate/precuneus, and posterior right middle temporal gyrus. This interaction was unrelated to subjective drug effects.
CONCLUSIONS
These findings suggest that stimulant drugs may change the relative sensitivity of higher order sensory processing to increase visual attention when viewing less complex stimuli. Moreover, MA-induced alterations in this type of sensory processing appear to be independent of the drugs' ability to increase feelings of well-being.",2019,"Further, MA increased activation only for low NSE images in three areas of visual association cortex: left fusiform, right cingulate/precuneus, and posterior right middle temporal gyrus.",['Healthy adult participants (n\u2009=\u200918'],"['MA and placebo', 'methamphetamine', 'methamphetamine (MA', 'MA']","['subjective drug effects', 'neural responses to visual stimuli', 'neural function']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0546401,"Further, MA increased activation only for low NSE images in three areas of visual association cortex: left fusiform, right cingulate/precuneus, and posterior right middle temporal gyrus.","[{'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Van Hedger', 'Affiliation': 'Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Keedy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S. Maryland Ave, Chicago, IL, 60637, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Schertz', 'Affiliation': 'Department of Psychology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Berman', 'Affiliation': 'Department of Psychology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S. Maryland Ave, Chicago, IL, 60637, USA. hdew@uchicago.edu.'}]",Psychopharmacology,['10.1007/s00213-018-5156-5']
1575,31842921,"Autologous bone marrow expanded mesenchymal stem cells in patellar tendinopathy: protocol for a phase I/II, single-centre, randomized with active control PRP, double-blinded clinical trial.","INTRODUCTION
Patellar tendon overuse injuries are common in athletes. Imaging may show a change in tissue structure with tendon thickening and disruption of the intratendinous substance. We wish to test the hypothesis that both autologous bone marrow expanded mesenchymal stem cells and autologous leukocyte-poor platelet-rich plasma (LP-PRP) implanted into the area of the disrupted tendinopathic patellar tendon will restore function, but tendon regeneration tissue will only be observed in the subjects treated with autologous bone marrow expanded mesenchymal stem cells.
METHODS AND ANALYSIS
This is a single-centre, pilot phase I/II, double-blinded clinical trial with randomisation with active control. Twenty patients with a diagnosis of patellar tendinopathy with imaging changes (tendon thickening and disruption of the intratendinous substance at the proximal portion of the patellar tendon) will be randomised in a 1:1 ratio to receive a local injection of either bone-marrow autologous mesenchymal stem cells (MSC), isolated and cultured under GMP at The Institute of Biology and Molecular Genetics (IBGM) (Spain) or P-PRP. The study will have two aims: first, to ascertain whether a clinically relevant improvement after 3, 6 and 12 months according to the visual analogue scale (VAS), Victorian Institute of Sport Assessment for patellar tendons (VISA-P) and dynamometry scales (DYN) will be achieved; and second, to ascertain whether the proposed intervention will restore tendon structure as determined by ultrasonography (US), Doppler ultrasonography (DUS), and innovative MRI and ultrasound techniques: Magnetic Resonance T2 FAT SAT (UTE, Ultrashort Echo TE) sequence and Ultrasound Tissue Characterization (UTC). Patients who are randomised to the P-PRP treatment group but do not achieve a satisfactory primary endpoint after 6 months will be offered treatment with MSC.
TRIAL REGISTRATION
NCT03454737.",2019,"Twenty patients with a diagnosis of patellar tendinopathy with imaging changes (tendon thickening and disruption of the intratendinous substance at the proximal portion of the patellar tendon) will be randomised in a 1:1 ratio to receive a local injection of either bone-marrow autologous mesenchymal stem cells (MSC), isolated and cultured under GMP at The Institute of Biology and Molecular Genetics (IBGM) (Spain) or P-PRP.","['Twenty patients with a diagnosis of patellar tendinopathy with imaging changes (tendon thickening and disruption of the intratendinous substance at the proximal portion of the patellar tendon', 'patellar tendinopathy', 'subjects treated with autologous bone marrow expanded mesenchymal stem cells']","['autologous bone marrow expanded mesenchymal stem cells and autologous leukocyte-poor platelet-rich plasma (LP-PRP', 'Autologous bone marrow expanded mesenchymal stem cells', 'local injection of either bone-marrow autologous mesenchymal stem cells (MSC), isolated and cultured under GMP at The Institute of Biology and Molecular Genetics (IBGM) (Spain) or P-PRP']","['visual analogue scale (VAS), Victorian Institute of Sport Assessment for patellar tendons (VISA-P) and dynamometry scales (DYN', 'FAT SAT (UTE, Ultrashort Echo TE) sequence and Ultrasound Tissue Characterization (UTC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3854629', 'cui_str': 'Tendon thickening'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0206332', 'cui_str': 'Ligamentum Patellae'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0018346', 'cui_str': ""Guanosine 5'-Monophosphate""}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0005532', 'cui_str': 'Biology'}, {'cui': 'C0086345', 'cui_str': 'Genetics, Molecular'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0206332', 'cui_str': 'Ligamentum Patellae'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0222045'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1556092', 'cui_str': 'Utes (ethnic group)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",20.0,0.207384,"Twenty patients with a diagnosis of patellar tendinopathy with imaging changes (tendon thickening and disruption of the intratendinous substance at the proximal portion of the patellar tendon) will be randomised in a 1:1 ratio to receive a local injection of either bone-marrow autologous mesenchymal stem cells (MSC), isolated and cultured under GMP at The Institute of Biology and Molecular Genetics (IBGM) (Spain) or P-PRP.","[{'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Rodas', 'Affiliation': 'Medical Department, Football Club Barcelona, C/Aristides Maillol, s/n 08028, Barcelona, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Soler', 'Affiliation': 'ITRT Institut Terapia Regenerativa Tissular Centro Médico Teknon, C/Vilana 12. 08022, Barcelona, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Balius', 'Affiliation': ""Consell Català del'Esport, Unitat d'Esporti Salut Av Països Catalans, 40-48, 08950, Esplugues, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Alomar', 'Affiliation': 'Diagnóstico por la Imagen, Clínica Creu Blanca, Passeig de la Reina Elisenda de Montcada, 17, 08034, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Peirau', 'Affiliation': 'ITRT Institut Terapia Regenerativa Tissular Centro Médico Teknon, C/Vilana 12. 08022, Barcelona, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Alberca', 'Affiliation': 'Instituto de Biología y Genética Molecular (IBGM), Universidad Valladolid y CSIC Edificio IBGM, C/ Sanz y Forés, s/n, 47003, Valladolid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Sánchez', 'Affiliation': 'Instituto de Biología y Genética Molecular (IBGM), Universidad Valladolid y CSIC Edificio IBGM, C/ Sanz y Forés, s/n, 47003, Valladolid, Spain.'}, {'ForeName': 'Javier García', 'Initials': 'JG', 'LastName': 'Sancho', 'Affiliation': 'Instituto de Biología y Genética Molecular (IBGM), Universidad Valladolid y CSIC Edificio IBGM, C/ Sanz y Forés, s/n, 47003, Valladolid, Spain.'}, {'ForeName': 'Clementina', 'Initials': 'C', 'LastName': 'Rodellar', 'Affiliation': 'LAGENBIO, Facultad de Veterinaria, Lab. Genética Bioquímica. Facultad de Veterinaria, Universidad de Zaragoza, C/Miguel Servet 177, 50013, Zaragoza, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'LAGENBIO, Facultad de Veterinaria, Lab. Genética Bioquímica. Facultad de Veterinaria, Universidad de Zaragoza, C/Miguel Servet 177, 50013, Zaragoza, Spain.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Masci', 'Affiliation': 'Institute of Sport Exercise and Health, London, UK.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Orozco', 'Affiliation': 'ITRT Institut Terapia Regenerativa Tissular Centro Médico Teknon, C/Vilana 12. 08022, Barcelona, Spain.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Department of Musculoskeletal Disorders, University of Salerno School of Medicine, Surgery and Dentistry, Salerno, Italy. n.maffulli@qmul.ac.uk.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-019-1477-2']
1576,30514434,"Effects of ""Visual Schema Displacement Therapy"" (VSDT), an abbreviated EMDR protocol and a control condition on emotionality and vividness of aversive memories: Two critical analogue studies.","BACKGROUND AND OBJECTIVES
Visual Schema Displacement Therapy (VSDT) is a novel therapy which has been described as a treatment for stress and dysfunction caused by a traumatic event. Although its developers claim this therapy is quicker and more beneficial than other forms of trauma therapy, its effectiveness has not been tested.
METHODS
We compared the efficacy of VSDT to an abbreviated EMDR protocol and a non-active control condition (CC) in two studies. In Study 1 participants (N = 30) were asked to recall three negative emotional memories under three conditions: VSDT, EMDR, and a CC, each lasting 8 min. Emotional disturbance and vividness of the memories were rated before and after the (within group) conditions. The experiment was replicated using a between group study. In Study 2 participants (N = 75) were assigned to one of the three conditions, and a follow-up after 6-8 days was added.
RESULTS
In both studies VSDT and EMDR were superior to the CC in reducing emotional disturbance, and VSDT was superior to EMDR. VSDT and EMDR outperformed the CC in terms of reducing vividness.
LIMITATION
Results need to be replicated in clinical samples.
CONCLUSIONS
It is unclear how VSDT yields positive effects, but irrespective of its causal mechanisms, VSDT warrants clinical exploration.",2019,"In both studies VSDT and EMDR were superior to the CC in reducing emotional disturbance, and VSDT was superior to EMDR.","['In Study 2 participants (N\u202f=\u202f75', 'In Study 1 participants (N\u202f=\u202f30']","['Visual Schema Displacement Therapy"" (VSDT', 'VSDT', 'Visual Schema Displacement Therapy (VSDT', 'VSDT and EMDR']","['emotionality and vividness of aversive memories', 'Emotional disturbance and vividness of the memories', 'emotional disturbance, and VSDT']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0870535', 'cui_str': 'EMDR'}]","[{'cui': 'C0542317', 'cui_str': 'Character trait finding of affective stability'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0013985', 'cui_str': 'Emotional Disturbances'}]",75.0,0.0217137,"In both studies VSDT and EMDR were superior to the CC in reducing emotional disturbance, and VSDT was superior to EMDR.","[{'ForeName': 'Suzy J M A', 'Initials': 'SJMA', 'LastName': 'Matthijssen', 'Affiliation': 'Altrecht Academic Anxiety Centre, Altrecht GGz, Utrecht, the Netherlands; Department of Clinical Psychology, Utrecht University, Utrecht, the Netherlands. Electronic address: s.matthijssen@altrecht.nl.'}, {'ForeName': 'Lucinda M', 'Initials': 'LM', 'LastName': 'van Beerschoten', 'Affiliation': 'Stichting Elisabeth, Breda, the Netherlands; Careyn, Maarssen, the Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'de Jongh', 'Affiliation': 'PSYTREC, Bilthoven, the Netherlands; Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU University Amsterdam, the Netherlands; School of Health Sciences, Salford University, Manchester, United Kingdom; Institute of Health and Society, University of Worcester, United Kingdom.'}, {'ForeName': 'Irene G', 'Initials': 'IG', 'LastName': 'Klugkist', 'Affiliation': 'Methodology and Statistics of Social and Behavioural Sciences, Utrecht University, Utrecht, the Netherlands; Research Methodology, Measurement and Data Analysis of Behavioural, Management and Social Sciences, Twente University, Enschede, the Netherlands.'}, {'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'van den Hout', 'Affiliation': 'Altrecht Academic Anxiety Centre, Altrecht GGz, Utrecht, the Netherlands; Department of Clinical Psychology, Utrecht University, Utrecht, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2018.11.006']
1577,31606362,Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.,"OBJECTIVES
This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.
BACKGROUND
Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.
METHODS
The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria.
RESULTS
Among 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p < 0.02), with consistent mortality findings by race and sex. After propensity score matching, mortality rates were similar; however, trial-eligible patients continued to have higher rates of 30-day readmission (23.1% vs. 17.3%; p < 0.01), driven by differences among black patients and women (all p for interaction ≤0.02).
CONCLUSIONS
Patients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).",2019,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","['20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial ', 'trial randomized patients hospitalized for HF to receive', '79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n\xa0=\xa037,883 [77.2%]; black, n\xa0=\xa011,180 [22.8', 'Decompensated Heart\xa0Failure', 'Decompensated Heart Failure', 'non-Hispanic white (n\xa0=\xa01,494) and black (n\xa0=\xa01,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e.,\xa0Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria', 'from May 2007 to August 2010 and was neutral for clinical endpoints']","['nesiritide or placebo', 'Nesiritide']","['30-day readmission', 'blood pressure and higher ejection fraction', 'mortality rates', 'hospital mortality']","[{'cui': 'C4517642', 'cui_str': '20.2 (qualifier value)'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",,0.20658,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina. Electronic address: stephen.greene@duke.edu.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke Forge, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Stanford University, Stanford, California; Verily Life Sciences (Alphabet), South San Francisco, California.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Matsouaka', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Samman Tahhan', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Clyde W', 'Initials': 'CW', 'LastName': 'Yancy', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.07.011']
1578,31606364,Hyperkalemia and Treatment With RAAS Inhibitors During Acute Heart Failure Hospitalizations and Their Association With Mortality.,"OBJECTIVES
This study investigated associations between incident hyperkalemia during acute heart failure (HF) hospitalizations and changes in renin-angiotensin-aldosterone system (RAAS) inhibitors.
BACKGROUND
Hyperkalemia is a potential complication of RAAS inhibitors. For patients with HF, fear of hyperkalemia may lead to failure to deliver guideline-recommended doses of RAAS inhibitors.
METHODS
Serum potassium concentrations were measured daily from baseline (<24 h after admission) until discharge or day 7 in 1,589 patients enrolled in the PROTECT (Placebo-Controlled Randomized Study of the Selective A1 Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function) trial. Incident hyperkalemia was defined as at least 1 episode of potassium >5.0 mEq/l. The primary outcome was all-cause mortality at 180 days.
RESULTS
Overall, serum potassium concentrations increased from 4.3 ± 0.6 mEq/l at baseline to 4.5 ± 0.6 mEq/l at discharge or day 7 (p < 0.001). Patients developing incident hyperkalemia (n = 564; 35%) were more often taking mineralocorticoid antagonists (MRAs) therapy prior to hospitalization and were more likely to have them down-titrated during hospitalization, independent of confounders. Incident hyperkalemia was not associated with adverse outcomes. Yet, down-titration of MRAs during hospitalization was independently associated with 180-day mortality (hazard ratio [HR]: 1.73; 95% confidence interval [CI]: 1.15 to 2.60), regardless of incident hyperkalemia (p interaction >0.10). Patients with incident hyperkalemia who were discharged with the same or increased dose of MRAs (HR: 0.52; 95% CI: 0.32 to 0.85) or angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) (HR: 0.47; 95% CI: 0.29 to 0.77) had a lower 180-day mortality.
CONCLUSIONS
Incident hyperkalemia is common in patients hospitalized for acute HF and is not associated with adverse outcomes. Incident hyperkalemia is associated with down-titration of MRAs, but patients who maintained or increased their dose of MRAs and/or ACE inhibitors/ARB during acute HF hospitalization had better 180-day survival.",2019,"Patients developing incident hyperkalemia (n = 564; 35%) were more often taking mineralocorticoid antagonists (MRAs) therapy prior to hospitalization and were more likely to have them down-titrated during hospitalization, independent of confounders.","['1,589 patients enrolled in the', 'Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function) trial']","['RAAS-Inhibitors', 'PROTECT (Placebo', 'Selective A1 Adenosine Receptor Antagonist Rolofylline', 'angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs']","['incident hyperkalemia', '180-day mortality', 'Overall, serum potassium concentrations', 'cause mortality', 'Incident hyperkalemia', '180-day survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0700148', 'cui_str': 'Congestion (morphologic abnormality)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936829', 'cui_str': 'Adenosine Receptor Antagonists'}, {'cui': 'C0166128', 'cui_str': 'rolofylline'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0014432', 'cui_str': 'Enzyme Inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1589.0,0.301539,"Patients developing incident hyperkalemia (n = 564; 35%) were more often taking mineralocorticoid antagonists (MRAs) therapy prior to hospitalization and were more likely to have them down-titrated during hospitalization, independent of confounders.","[{'ForeName': 'Joost C', 'Initials': 'JC', 'LastName': 'Beusekamp', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Tromp', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands; Department of Cardiology, National Heart Centre Singapore, Singapore; Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Department of Cardiology, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'University of California at San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Cardiology, Medical University, Clinical Military Hospital, Wroclaw, Poland.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Ouwerkerk', 'Affiliation': 'Department of Cardiology, National Heart Centre Singapore, Singapore; Department of Dermatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam Infection and Immunity Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands. Electronic address: p.van.der.meer@umcg.nl.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.07.010']
1579,30630772,"Rituximab in patients with primary CNS lymphoma (HOVON 105/ALLG NHL 24): a randomised, open-label, phase 3 intergroup study.","BACKGROUND
The prognosis for primary CNS lymphoma has improved with the use of high-dose methotrexate-based chemotherapy, but patient outcomes remain poor. Rituximab, a chimeric monoclonal antibody that targets the CD20 cell surface protein, has substantial activity in systemic CD20-positive diffuse large B-cell lymphoma, but its efficacy in primary CNS lymphoma is unknown and low penetration of the large rituximab molecule through the blood-brain barrier could limit its effect. We aimed to investigate the addition of rituximab to a high-dose methotrexate-based chemotherapy regimen in patients with newly diagnosed primary CNS lymphoma.
METHODS
This intergroup, multicentre, open-label, randomised phase 3 study was done at 23 hospitals in the Netherlands, Australia, and New Zealand. Non-immunocompromised patients aged 18-70 years with newly diagnosed primary CNS lymphoma were randomly assigned (1:1) to receive methotrexate-based chemotherapy with or without intravenous rituximab. We used a web-based randomisation system with stratification by centre, age, and Eastern Cooperative Oncology Group-WHO performance status, and a minimisation procedure. All group assignment was open label and neither investigators nor patients were masked to allocation. All patients were treated with two 28-day cycles of induction chemotherapy, consisting of intravenous methotrexate 3 g per m 2 on days 1 and 15, intravenous carmustine 100 mg per m 2 on day 4, intravenous teniposide 100 mg per m 2 on days 2 and 3, and oral prednisone 60 mg per m 2 on days 1-5, with (R-MBVP) or without (MBVP) intravenous rituximab 375 mg per m 2 on days 0, 7, 14, and 21 in cycle one and days 0 and 14 in cycle two. Patients with response at the end of induction subsequently received high-dose cytarabine and, in patients aged 60 years or younger, low-dose whole-brain radiotherapy. The primary endpoint was event-free survival, with events defined as not reaching complete response or complete response unconfirmed at the end of treatment, or progression or death after response; analysis was adjusted for age and performance score. Patients were analysed on a modified intention-to-treat basis. This trial is registered with the Nederlands Trial Register, number NTR2427, and the Australian New Zealand Clinical Trials Registry, number ACTRN12610000908033. The trial was closed on May 27, 2016, after achieving complete accrual, and follow-up is ongoing.
FINDINGS
Between Aug 3, 2010, and May 27, 2016, we recruited 200 patients (109 men and 91 women; median age was 61 years [IQR 55-67]). We randomly assigned 100 patients to MBVP and 99 patients to R-MBVP. One patient was randomly assigned to the R-MBVP group but found to be ineligible because of an incorrect diagnosis and was excluded from all analyses. After a median follow-up of 32·9 months (IQR 23·9-51·5), 98 patients had had an event (51 in the MBVP group and 47 in the R-MBVP group), of whom 79 had died (41 in the MBVP group and 38 in the R-MBVP group). Event-free survival at 1 year was 49% (95% CI 39-58) in the MBVP group (no rituximab) and 52% (42-61) in the R-MBVP group (with rituximab; hazard ratio 1·00, 95% CI 0·70-1·43, p=0·99). Grade 3 or 4 adverse events occurred in 58 (58%) patients in the MBVP group and 63 (64%) patients in the R-MBVP group, with infections (24 [24%] patients receiving MBVP vs 21 [21%] patients receiving R-MBVP), haematological toxicity (15 [15%] vs 12 [12%]), and nervous system disorders (ten [10%] vs 15 [15%]) being the most common. Life-threatening or fatal serious adverse events occurred in 12 (12%) patients in the MBVP group and ten (10%) patients in the R-MBVP group, and five (5%) patients in the MBVP group and three (3%) in the R-MBVP group died from treatment-related causes.
INTERPRETATION
We found no clear benefit of addition of rituximab to methotrexate, carmustine, teniposide, and prednisone chemotherapy in primary CNS lymphoma. Therefore, the results of this study do not support the use of rituximab as a component of standard treatment in primary CNS lymphoma.
FUNDING
Roche, the Dutch Cancer Society, and Stichting STOPhersentumoren.",2019,"Event-free survival at 1 year was 49% (95% CI 39-58) in the MBVP group (no rituximab) and 52% (42-61) in the R-MBVP group (with rituximab; hazard ratio 1·00, 95% CI 0·70-1·43, p=0·99).","['patients with primary CNS lymphoma (HOVON 105/ALLG NHL 24', 'primary CNS lymphoma', 'Patients with response at the end of induction subsequently received', 'Between Aug 3, 2010, and May 27, 2016', 'patients with newly diagnosed primary CNS lymphoma', '200 patients (109 men and 91 women; median age was 61 years [IQR 55-67', '23 hospitals in the Netherlands, Australia, and New Zealand. Non-immunocompromised patients aged 18-70 years with newly diagnosed primary CNS lymphoma']","['Rituximab', 'carmustine 100 mg per m 2 on day 4, intravenous teniposide 100 mg per m 2 on days 2 and 3, and oral prednisone 60 mg per m 2 on days 1-5, with (R-MBVP) or without (MBVP) intravenous rituximab', 'MBVP', 'methotrexate-based chemotherapy', 'methotrexate-based chemotherapy with or without intravenous rituximab', 'low-dose whole-brain radiotherapy', 'rituximab to methotrexate, carmustine, teniposide, and prednisone chemotherapy', 'induction chemotherapy, consisting of intravenous methotrexate', 'methotrexate-based chemotherapy regimen', 'rituximab', 'high-dose cytarabine']","['Event-free survival', 'event-free survival, with events defined as not reaching complete response or complete response unconfirmed at the end of treatment, or progression or death', 'Grade 3 or 4 adverse events', 'haematological toxicity', 'Life-threatening or fatal serious adverse events', 'nervous system disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4074474', 'cui_str': 'Carmustine 100 MG [BiCNU]'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}]",100.0,0.173391,"Event-free survival at 1 year was 49% (95% CI 39-58) in the MBVP group (no rituximab) and 52% (42-61) in the R-MBVP group (with rituximab; hazard ratio 1·00, 95% CI 0·70-1·43, p=0·99).","[{'ForeName': 'Jacoline E C', 'Initials': 'JEC', 'LastName': 'Bromberg', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands. Electronic address: j.bromberg@erasmusmc.nl.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Issa', 'Affiliation': 'Department of Hematology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Bakunina', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Seute', 'Affiliation': 'Department of Neurology, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Durian', 'Affiliation': 'Department of Hematology, ETZ Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Cull', 'Affiliation': 'Haematology Department, Sir Charles Gairdner Hospital and PathWest Laboratory Medicine, Nedlands, WA, Australia; University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Harry C', 'Initials': 'HC', 'LastName': 'Schouten', 'Affiliation': 'Department of Hematology, University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Wendy B C', 'Initials': 'WBC', 'LastName': 'Stevens', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Josee M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Hematology, Amsterdam UMC-Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Joke W', 'Initials': 'JW', 'LastName': 'Baars', 'Affiliation': 'Department of Hemato-Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Nijland', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Kylie D', 'Initials': 'KD', 'LastName': 'Mason', 'Affiliation': 'Department of Hematology, Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Hematology, Spaarne Gasthuis, Haarlem, Netherlands.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Beijert', 'Affiliation': 'Department of Radiotherapy, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gonzales', 'Affiliation': 'Department of Anatomical Pathology, Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'de Jong', 'Affiliation': 'Department of Pathology, Amsterdam UMC-Vrije Universiteit Amsterdam, Amsterdam, Netherlands; HOVON Pathology Facility and Biobank, Amsterdam, Netherlands.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30747-2']
1580,30629845,Early rapid weight gain among formula-fed infants: Impact of formula type and maternal feeding styles.,"BACKGROUND
What and how infants are fed are considered important determinants for the risk factor of early rapid gain weight.
OBJECTIVES
We conducted secondary analyses on data from a randomized clinical trial, wherein infants randomized to feed cow milk formula had double the incidence of early rapid weight gain than those fed extensively hydrolyzed protein formula, to determine whether maternal feeding styles had independent effects or interactive effects with infant formula type on early rapid weight gain.
METHODS
Anthropometry and feeding patterning (number of daily formula feeds) were measured monthly, and maternal feeding styles were measured at 0.5, 3.5, and 4.5 months. Longitudinal models were fitted using generalized estimating equations and separate logistic models conducted.
RESULTS
The treatment groups did not differ in formula feeding patterning or in maternal feeding styles, which were stable across the first 4.5 months. Feeding styles had no significant effects on early rapid weight gain and did not interact with formula group. However, type of infant formula had a direct and independent impact on early rapid weight gain (P = 0.003).
CONCLUSIONS
The type of infant formula had a differential impact on early rapid weight gain independent of maternal feeding style, highlighting the self-regulatory capabilities of infants.",2019,"The treatment groups did not differ in formula feeding patterning or in maternal feeding styles, which were stable across the first 4.5 months.","['formula-fed infants', 'infants']",['feed cow milk formula'],"['Early rapid weight gain', 'maternal feeding styles', 'early rapid weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.128717,"The treatment groups did not differ in formula feeding patterning or in maternal feeding styles, which were stable across the first 4.5 months.","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Mennella', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Papas', 'Affiliation': 'Christiana Care Health System Value Institute, Newark, Delaware.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Reiter', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Trabulsi', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware College of Health and Sciences, Newark, Delaware.'}]",Pediatric obesity,['10.1111/ijpo.12503']
1581,30617786,Training endogenous pain modulation: a preliminary investigation of neural adaptation following repeated exposure to clinically-relevant pain.,"Analgesic treatments that aim to eliminate pain display marginal success in relieving chronic pain and may increase pain vulnerability. Repeated exposure to pain may result in increased pain modulation via engagement of anti-nociceptive brain regions. It was hypothesized that repeated exposure to delayed onset muscle soreness (DOMS) would result in increased pain modulatory capacity (PMC) via functional neural adaptation. 23 healthy participants completed Baseline and Follow Up resting-state fMRI and quantitative sensory testing (QST) visits 40 days apart. Participants were randomized to two groups: A Repeated DOMS Group (RD Group) that received four, weekly DOMS inductions and a Control Group that received one baseline induction. Daily pain ratings were collected for seven days post-induction, as were quantitative sensory testing (QST) metrics at baseline and Follow Up. Regional functional connectivity (FC) was estimated among areas involved in pain modulation. Seed and network FC was estimated among areas involved in pain modulation and sensory processing. Changes in FC were compared between groups. The RD Group displayed significant reductions in post-DOMS pain ratings and significant changes in thermal QST measures. RD Group participants displayed greater adaptation in nucleus accumbens-medial prefrontal cortex (NAc-mPFC) FC and in sensorimotor network (SMN) connectivity with the dorsomedial, ventromedial, and rostromedial prefrontal cortices. Changes in SMN-PFC connectivity correlated with reductions in post-DOMS affective distress. Results suggest that repeated exposure to clinically-relevant pain results in adaptations among brain regions involved in pain modulation. Repeated exposure to clinically-relevant pain may serve as a mechanism to increase PMC via inhibition of emotional valuation of painful stimuli.",2020,The RD Group displayed significant reductions in post-DOMS pain ratings and significant changes in thermal QST measures.,['23 healthy participants completed Baseline and Follow Up resting-state fMRI and quantitative sensory testing (QST) visits 40\xa0days apart'],"['DOMS Group (RD Group) that received four, weekly DOMS inductions and a Control Group that received one baseline induction']","['Seed and network FC', 'quantitative sensory testing (QST) metrics', 'pain modulatory capacity (PMC) via functional neural adaptation', 'Changes in FC', 'thermal QST measures', 'pain vulnerability', 'Regional functional connectivity (FC', 'post-DOMS pain ratings', 'Daily pain ratings', 'adaptation in nucleus accumbens-medial prefrontal cortex (NAc-mPFC) FC and in\xa0sensorimotor network (SMN) connectivity with the dorsomedial, ventromedial, and rostromedial prefrontal cortices']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",23.0,0.271475,The RD Group displayed significant reductions in post-DOMS pain ratings and significant changes in thermal QST measures.,"[{'ForeName': 'Landrew', 'Initials': 'L', 'LastName': 'Sevel', 'Affiliation': 'Osher Center for Integrative Medicine at Vanderbilt, Department of Physical Medicine & Rehabilitation, Vanderbilt University Medical Center, Suite 380, 3401 West End Avenue, Nashville, TN, 37203, USA. landrew.s.sevel@vanderbilt.edu.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Meryl', 'Initials': 'M', 'LastName': 'Alappattu', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bishop', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}]",Brain imaging and behavior,['10.1007/s11682-018-0033-8']
1582,31144279,"Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial.","BACKGROUND
There is limited experimental evidence on transitional care interventions beyond 30 days post-discharge and in vulnerable populations.
OBJECTIVE
Evaluate effects of a transitional care practice (TC) that comprehensively addresses patients' medical and psychosocial needs following hospital discharge.
DESIGN
Pragmatic, randomized comparative effectiveness trial.
PATIENTS
Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care.
INTERVENTIONS
TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source. Routine Care involved assistance scheduling a post-discharge appointment with a primary care provider that often partnered with the hospital where the initial encounter occurred.
MAIN MEASURES
The primary outcome was a binary indicator of death or additional hospital encounters within 90 days of initial discharge. Secondary outcomes included any additional hospital encounters, and counts of hospital encounters, over 180 days.
KEY RESULTS
Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area. There was no significant difference between arms in the 90-day probability of death or additional hospital encounters (relative risk [RR] 0.89; 0.91; 95% confidence interval [CI] 0.74-1.13). However, TC patients had 37% and 35% lower probability of any inpatient admission over 90 days (RR 0.63; 95% CI 0.43-0.91) and 180 days (RR 0.65; 95% CI 0.47-0.89), respectively. Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90).
CONCLUSIONS
Among patients randomized to a patient-centered transitional care intervention, there was no significant reduction in 90-day probability of death or additional hospital encounters. However, there were significant decreases in measures of inpatient admissions over 180 days.
TRIAL REGISTRATION
clinicaltrials.gov identifier NCT03066492.",2019,"Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90).
","['Vulnerable Population', 'Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area', 'Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care']","['Transitional Care Practice', ""TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source"", 'transitional care practice (TC']","['inpatient admissions', '90-day probability of death or additional hospital encounters', 'additional hospital encounters, and counts of hospital encounters, over 180\xa0days', 'binary indicator of death or additional hospital encounters within 90\xa0days of initial discharge', 'probability of any inpatient admission', 'measures of inpatient admissions']","[{'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032855', 'cui_str': 'Poverty Areas'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",490.0,0.412341,"Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90).
","[{'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Liss', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. david.liss@northwestern.edu.'}, {'ForeName': 'Ronald T', 'Initials': 'RT', 'LastName': 'Ackermann', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Finch', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Hurt', 'Affiliation': 'PCPI Foundation, Chicago, IL, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lancki', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Sheth', 'Affiliation': 'Department of Family and Community Medicine, Cook County Health and Hospitals System, Chicago, IL, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Teter', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schaeffer', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05078-4']
1583,30596538,The impact of a planned health educational program on the compliance and knowledge of Jordanian pregnant women with anemia.,"Iron deficiency anemia is a major public health problem among pregnant women in developing countries. This study aimed to use a randomized controlled trial to evaluate the effectiveness of a health information package in Jordanian anemic pregnant women's knowledge regarding anemia, compliance with iron supplementation, and hemoglobin level. Two hundred pregnant anemic women were recruited and randomly assigned into intervention or control group from April to July 2016. The intervention group received a video presentation of the Health Information Package Program (HIPP), narrated by a midwife, combined with PowerPoint slides to educate women about anemia in pregnancy. The participants in the control group received standard care in antenatal clinics, including iron supplementation. No significant differences were observed between the groups in age, gestational age, health problems, and total income. Only education and source of information differed significantly between the groups. Women in the intervention group had higher scores on the compliance checklist, knowledge, food selection ability, and hemoglobin level than women in the control group. The health information package program was effective. Policymakers should adopt a health information package program and apply it as a comprehensive national strategy for the prevention of anemia during pregnancy.",2019,"Women in the intervention group had higher scores on the compliance checklist, knowledge, food selection ability, and hemoglobin level than women in the control group.","['Jordanian pregnant women with anemia', 'Two hundred pregnant anemic women', ""Jordanian anemic pregnant women's"", 'pregnant women in developing countries']","['video presentation of the Health Information Package Program (HIPP), narrated by a midwife, combined with PowerPoint slides', 'standard care in antenatal clinics, including iron supplementation', 'health information package', 'planned health educational program']","['knowledge regarding anemia, compliance with iron supplementation, and hemoglobin level', 'compliance checklist, knowledge, food selection ability, and hemoglobin level']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011750', 'cui_str': 'Under-Developed Nations'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0016488', 'cui_str': 'Food Selection'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",200.0,0.0522715,"Women in the intervention group had higher scores on the compliance checklist, knowledge, food selection ability, and hemoglobin level than women in the control group.","[{'ForeName': 'Sanaa', 'Initials': 'S', 'LastName': 'Abujilban', 'Affiliation': 'a Department of Maternal, Child and Family Health Nursing , Hashemite University College of Nursing , Zarqa , Jordan.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Hatamleh', 'Affiliation': 'b Department of Nursing , Jordan University of Science and Technology , Irbid , Jordan.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Al-Shuqerat', 'Affiliation': ""c Department of Nursing , Al-Hussein Bin Talal University , Ma'an , Jordan.""}]",Women & health,['10.1080/03630242.2018.1549644']
1584,31675086,"Effectiveness of Universal School-Based Screening vs Targeted Screening for Major Depressive Disorder Among Adolescents: A Trial Protocol for the Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) Randomized Clinical Trial.","Importance
The prevalence of annual major depressive disorder (MDD) episodes among adolescents in the United States rose from 8.3% in 2008 to 12.8% in 2016. Despite the US Preventive Services Task Force 2009 endorsement and 2016 reaffirmation of universal adolescent MDD screening in primary care, many adolescents are missed, as more than 60% lack annual preventive health visits and MDD screening remains inconsistent.
Objective
To compare the effectiveness of universal school-based screening for adolescent MDD vs the existing process of targeted screening based on observable behavior.
Design, Setting, and Participants
Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) is a randomized clinical trial that will take place in at least 8 Pennsylvania public high schools among at least 9650 students enrolled in 9th through 12th grade. Students will be randomized by grade to either targeted screening (current process) or universal screening (intervention). Students in the targeted screening arm will complete mandated school health screenings, which do not include an MDD screening. These students will be observed through the academic year for referral to the Student Assistance Program (SAP), required in all Pennsylvania schools. If a student exhibits behavior concerning for MDD raised by any contact (eg, teacher, parent, peer, or self-referral), SAP will triage the student and provide follow-up recommendations. Students in the universal screening arm will complete the validated Patient Health Questionnaire-9 (PHQ-9) from September through December of the academic year. The PHQ-9 includes 9 close-ended questions and is scored from 0 to 27. Students with a positive result (ie, score >10) will proceed to SAP triage. Students in the intervention arm will also be observed for behavior concerning for MDD during the school year, potentially prompting SAP triage referral. The primary outcome will be the proportion of adolescents referred to SAP triage who are recommended for additional MDD-related services and successfully engage with at least 1 SAP recommendation. Observers will not be blinded to patient groups, and an intention-to-treat analysis will be used.
Discussion
The SHIELD trial began with 3 schools during the 2018-2019 academic year. Screening in the intervention arm with the PHQ-9 is currently underway for the remaining schools, with a goal of completion of all PHQ-9 screenings by December 2019. This trial addresses the US Preventive Services Task Force call for large, high-quality randomized clinical trials to better understand the effects of MDD screening and quantify the proportion of adolescents with screen-detected MDD successfully referred and treated.
Trial Registration
ClinicalTrials.gov identifier: NCT03716869.",2019,The primary outcome will be the proportion of adolescents referred to SAP triage who are recommended for additional MDD-related services and successfully engage with at least 1 SAP recommendation.,"['Students with a positive result', 'least 8 Pennsylvania public high schools among at least 9650 students enrolled in 9th through 12th grade', '3 schools during the 2018-2019 academic year', 'Major Depressive Disorder', 'Adolescents', 'adolescents in the United States rose from 8.3% in 2008 to 12.8% in 2016', 'adolescents with screen-detected MDD successfully referred and treated']","['targeted screening (current process) or universal screening (intervention', 'Universal School-Based Screening vs Targeted Screening', 'universal school-based screening', 'universal adolescent MDD screening']","['prevalence of annual major depressive disorder (MDD) episodes', 'proportion of adolescents referred to SAP triage who are recommended for additional MDD-related services and successfully engage with at least 1 SAP recommendation']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]",2009.0,0.132386,The primary outcome will be the proportion of adolescents referred to SAP triage who are recommended for additional MDD-related services and successfully engage with at least 1 SAP recommendation.,"[{'ForeName': 'Deepa L', 'Initials': 'DL', 'LastName': 'Sekhar', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Pattison', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Confair', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Molinari', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schaefer', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Waxmonsky', 'Affiliation': 'Department of Psychiatry, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Walker-Harding', 'Affiliation': ""Department of Pediatrics, Seattle Children's, Seattle, Washington.""}, {'ForeName': 'Perri', 'Initials': 'P', 'LastName': 'Rosen', 'Affiliation': 'Garrett Lee Smith Youth Suicide Prevention Grant, Harrisburg, Pennsylvania.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kraschnewski', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14427']
1585,30632455,Napping Improves HRV in Older Patients With Cardiovascular Risk Factors.,"Heart rate variability (HRV), especially increased high frequency (HF), has been reported to provide clinically useful prognostic information regarding cardiovascular disease. Napping is an excellent sleep management strategy in older adults. This study was conducted to clarify the effect of napping on HRV in older adult patients with cardiovascular risk factors. The patients were divided into two groups: one group of 32 patients who reported napping (nap group) and another group of 45 patients who did not report napping (nonnap group). The HRV was calculated in terms of the HF component over 24 hr during wakefulness, sleep, and 1 hr after sleep onset. The HF in the nap group was significantly higher than that in the nonnap group during all times measured. In addition, napping was a significant predictor of increased HF. This study shows the effectiveness of napping in the daily lives of patients with cardiovascular risk factors.",2019,The HF in the nap group was significantly higher than that in the nonnap group during all times measured.,"['older adult patients with cardiovascular risk factors', 'patients with cardiovascular risk factors', 'Older Patients With Cardiovascular Risk Factors', 'older adults']",['reported napping (nap group) and another group of 45 patients who did not report napping (nonnap group'],"['HRV', 'HF', 'Heart rate variability (HRV']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",45.0,0.019108,The HF in the nap group was significantly higher than that in the nonnap group during all times measured.,"[{'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': '1 Nagoya University Graduate School of Medicine, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': '1 Nagoya University Graduate School of Medicine, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Miyachi', 'Affiliation': '2 Chutoen General Medical Center, Kakegawa, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Negi', 'Affiliation': '3 Negi Clinic, Inazawa, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': '4 Watanabe Medical Clinic, Taketoyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hirai', 'Affiliation': '5 Sugiyama Jogakuen University, Nagoya, Japan.'}]",Western journal of nursing research,['10.1177/0193945918824603']
1586,30523504,Do ultraviolet photos increase sun safe behavior expectations via fear? A randomized controlled trial in a sample of U.S. adults.,"Ultraviolet (UV) photos reveal the world in a different light spectrum, including damage that is caused by UV light. In the context of skin cancer control, UV photos have the potential to communicate fear because they reveal underlying skin damage. U.S. adults (N = 2219) were assigned to a 5 (visual: UV skin damage, sun exposure, sunburn, photoaging, and mole removal) × 3 (replication: three examples of each visual condition) × 4 (efficacy: no efficacy, text only, visual, visual + text) randomized controlled trial. Compared to all other visual conditions combined, UV skin damage visuals generated greater fear which triggered increased sun safe behavior expectations. Compared with other visual conditions separately, only mole removal visuals produced equivalent fear as UV skin damage visuals. Visual efficacy conditions appeared to nullify rather than magnify the indirect path through fear. The results suggest one way UV images impact sun safe behavioral expectations is via fear and that researchers should continue to examine the position of fear in fear appeal theories.",2019,"Compared to all other visual conditions combined, UV skin damage visuals generated greater fear which triggered increased sun safe behavior expectations.","['sample of U.S. adults', 'U.S. adults (N\u2009=\u20092219']","['5 (visual: UV skin damage, sun exposure, sunburn, photoaging, and mole removal)\u2009×\u20093']","['sun safe behavior expectations', 'Visual efficacy conditions']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0038814', 'cui_str': 'Sunburn'}, {'cui': 'C0027962', 'cui_str': 'Pigmented Moles'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",2219.0,0.0413624,"Compared to all other visual conditions combined, UV skin damage visuals generated greater fear which triggered increased sun safe behavior expectations.","[{'ForeName': 'Manusheela', 'Initials': 'M', 'LastName': 'Pokharel', 'Affiliation': 'Department of Communication, University of Utah, 2618 LNCO, 255 S. Central Campus Drive, Salt Lake City, UT, 84112, USA. pokharel.sh@gmail.com.'}, {'ForeName': 'Katheryn R', 'Initials': 'KR', 'LastName': 'Christy', 'Affiliation': 'School of Journalism and Mass Communication, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Jakob D', 'Initials': 'JD', 'LastName': 'Jensen', 'Affiliation': 'Department of Communication, University of Utah, 2618 LNCO, 255 S. Central Campus Drive, Salt Lake City, UT, 84112, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Giorgi', 'Affiliation': 'Department of Communication, University of Utah, 2618 LNCO, 255 S. Central Campus Drive, Salt Lake City, UT, 84112, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'John', 'Affiliation': 'School of Communications, Brigham Young University, Provo, USA.'}, {'ForeName': 'Yelena P', 'Initials': 'YP', 'LastName': 'Wu', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-018-9997-5']
1587,31675088,Effect of a Community Agency-Administered Nurse Home Visitation Program on Program Use and Maternal and Infant Health Outcomes: A Randomized Clinical Trial.,"Importance
Postnatal home visitation to support parenting and infant healthy development is becoming increasingly common based on university efficacy studies, but effectiveness when disseminated by communities is not clear.
Objective
To test implementation and impact of the Family Connects (FC) program when administered by a community agency.
Design, Setting, and Participants
In this randomized clinical trial, births were randomly assigned to receive FC or treatment as usual. Independent evaluation was conducted through parent interviews and review of health and child protective services records. Interviewers were blind to the experimental condition of participants, and participants were blind about the purpose of the interview as an intervention evaluation. A total of 936 consecutive residential births at Duke University Hospital from January 1, 2014, through June 30, 2014, were included. Data were analyzed preliminarily for reporting to funders in early 2015 before all birth-record covariates were scored and were analyzed more comprehensively in mid-2019 after administrative birth and child protective service records became available.
Interventions
The goals of the FC brief universal program were to assess family-specific needs, complete brief interventions, and connect families with community resources. Community agencies and families were aligned through an electronic data system.
Main Outcomes and Measures
Case records documented program penetration and quality. The primary outcome was child protective services investigations for maltreatment. Secondary outcomes were the number of sustained community connections, maternal mental health, parenting behavior, infant well-child care visits and maternal postpartum care compliance, and emergency health care utilization.
Results
Of 936 births, 451 infants (48.2%) were female and 433 (46.3%) were from racial/ethnic minority groups. In all, 456 births (46.5%) were randomized to the intervention and 480 (53.5%) were randomized to the control. All analyses were based on intention to treat. The impact analysis included 158 intervention families and 158 control families. Intervention penetration was 76%, adherence to the protocol was 90%, and independent agreement in scoring (κ) was 0.75. Nurses identified and addressed minor problems for 52% of families and connected an additional 42% to community resources. Analysis of the primary outcome of child abuse investigations revealed a mean (SD) of 0.10 (0.30) investigations for the intervention group vs 0.18 (0.56) investigations for the control group (b = -0.09; 90% CI, -0.01 to -0.12; 95% CI, -0.18 to 0.01; P = .07). The intervention group's rate of possible maternal anxiety or depression was 18.2% vs 25.9% for the control group (b = -7.70; 90% CI, -15.2 to -0.1; 95% CI, -16.6 to 1.3; P = .09).
Conclusions and Relevance
This study indicates that a nurse home visitation program for families of newborns can be implemented by a community agency with high penetration and quality. Other communities could benefit from wider dissemination of the program provided that quality remains strong and evaluation continues.
Trial Registration
ClinicalTrials.gov identifier: NCT01843036.",2019,The intervention group's rate of possible maternal anxiety or depression was 18.2% vs 25.9% for the control group (,"['936 consecutive residential births at Duke University Hospital from January 1, 2014, through June 30, 2014, were included', '158 intervention families and 158 control families', '456 births (46.5%) were randomized to the intervention and 480 (53.5', '936 births, 451 infants (48.2%) were female and 433 (46.3%) were from racial/ethnic minority groups']","['FC', 'Community Agency-Administered Nurse Home Visitation Program', 'Family Connects (FC) program']","['Intervention penetration', 'number of sustained community connections, maternal mental health, parenting behavior, infant well-child care visits and maternal postpartum care compliance, and emergency health care utilization', 'rate of possible maternal anxiety or depression', 'Program Use and Maternal and Infant Health Outcomes', 'program penetration and quality', 'child protective services investigations for maltreatment']","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",936.0,0.122137,The intervention group's rate of possible maternal anxiety or depression was 18.2% vs 25.9% for the control group (,"[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Dodge', 'Affiliation': 'Sanford School of Public Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'W Benjamin', 'Initials': 'WB', 'LastName': 'Goodman', 'Affiliation': 'Sanford School of Public Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Sanford School of Public Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14522']
1588,31595955,Growth During Infancy and Early Childhood and Its Association With Metabolic Risk Biomarkers at 11.5 Years of Age.,"The evidence that fetal life and early infancy are ""critical"" or ""sensitive"" ages for later development of cardiometabolic disease is based on flawed methods for comparing different age periods. Moreover, most previous studies have limited their focus to weight gain, rather than growth in length/height or body mass index (weight (kg)/height (m)2). We undertook a secondary analysis of data from the Promotion of Breastfeeding Intervention Trial (1996-2010), a birth cohort study nested within a large cluster-randomized trial in the Republic of Belarus, that had repeated measurements of weight and length/height taken from birth to 11.5 years of age. We used mixed-effects linear models to analyze associations of changes in standardized weight, length/height, and body mass index during 5 age periods (conception to birth, birth to age 3 months, ages 3-12 months, ages 12 months-6.5 years, and ages 6.5-11.5 years) with fasting glucose, insulin, insulin resistance, β-cell function, and adiponectin at age 11.5 years. We observed strong associations between the metabolic markers and all 3 growth measures, with the largest magnitudes being observed during the latest age period (ages 6.5-11.5 years) and negligible associations during gestation and the first year of life. Later age periods appear more ""sensitive"" than earlier periods to the adverse metabolic association with rapid growth in childhood.",2020,"We observed strong associations between the metabolic markers and all three growth measures, with the largest magnitudes observed during the latest age period (6.5 to 11.5 years) and negligible associations during gestation and the first year of life.","['PROBIT (1996-2010), a birth cohort study nested within a large cluster-randomized trial in the Republic of Belarus, with repeated measures of weight and length/height from birth to 11.5 years of age', 'at age 11.5 years']",[],"['standardized weight, length/height, and BMI', 'fasting glucose, insulin, insulin resistance, β-cell function, and adiponectin']","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2930714', 'cui_str': 'Republic of Belarus'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",,0.020093,"We observed strong associations between the metabolic markers and all three growth measures, with the largest magnitudes observed during the latest age period (6.5 to 11.5 years) and negligible associations during gestation and the first year of life.","[{'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'NIHR Bristol Biomedical Research Centre, Bristol, United Kingdom.'}, {'ForeName': 'Izzuddin M', 'Initials': 'IM', 'LastName': 'Aris', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Seungmi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Author affiliations: Department of Pediatrics, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}]",American journal of epidemiology,['10.1093/aje/kwz234']
1589,31675083,Effect of Escalating Financial Incentive Rewards on Maintenance of Weight Loss: A Randomized Clinical Trial.,"Importance
Identifying effective strategies for treating obesity is a public health priority.
Objective
To test an escalating lottery-based incentive tied to daily self-weighing for weight loss maintenance.
Design, Setting, and Participants
This 2-phase, 2-arm randomized clinical trial enrolled participants aged 30 to 80 years with an initial body mass index (calculated as weight in kilograms divided by height in meters squared) of 30.0 to 45.0 who lost at least 5 kg during 4 to 6 months in a national online weight management program. Study investigators and outcomes assessors were blinded to participant groups. Data were collected and analyzed from May 23, 2016, through November 13, 2017, based on intention to treat.
Interventions
All participants were advised to weigh themselves daily, with a goal of 6 or more days per week, and received text messaging feedback on their performance. Incentive group participants were eligible for a lottery-based incentive worth an expected value of $3.98 in week 1 that escalated by $0.43 each week they achieved their self-weighing goal during months 1 to 6 (phase 1), followed by no incentives during months 7 to 12 (phase 2).
Main Outcomes and Measures
The primary outcome was weight change at the end of phase 1. Secondary outcomes included weight change at the end of phase 2 and changes in self-reported physical activity and eating behaviors.
Results
A total of 258 participants (128 in the incentive group and 130 in the control group) had a mean (SD) age of 48.0 (10.5) years and mean (SD) body mass index of 32.1 (3.9); 225 (87.2%) were women; 235 (91.1%) were white; and 102 (39.5%) had an annual income of at least $100 000. Weight measurement was transmitted by 250 participants (96.9%) at 6 months and 227 (88.0%) at 12 months. The percentage of weeks that incentive and control participants achieved a mean self-weighing of at least 6 times was 85.3% vs 75.8%, respectively (P = .002) in phase 1 and 37.7% vs 50.2%, respectively (P = .009) in phase 2. Mean weight changes at the end of phase 1 were -1.1 (95% CI, -2.1 to -0.1) kg in the incentive group and -1.9 (95% CI, -2.9 to -0.8) kg in the control group, with a mean difference of 0.7 (95% CI, -0.7 to 2.2) kg (P = .30 for comparison). At the end of phase 2, mean weight changes were 0.2 (95% CI, -1.2 to 1.7) kg in the incentive group and -0.6 (95% CI, -2.0 to 0.8) kg in the control group, with a mean difference of 0.8 (95% CI, -1.2 to 2.8) kg (P = .41 for comparison).
Conclusions and Relevance
Compared with an active control condition of weekly messages, escalating lottery-based incentives transiently increased rates of self-weighing but did not significantly enhance weight loss maintenance.
Trial Registration
ClinicalTrials.gov identifier: NCT01900392.",2019,"Compared with an active control condition of weekly messages, escalating lottery-based incentives transiently increased rates of self-weighing but did not significantly enhance weight loss maintenance.
","['participants aged 30 to 80 years with an initial body mass index (calculated as weight in kilograms divided by height in meters squared) of 30.0 to 45.0 who lost at least 5 kg during 4 to 6 months in a national online weight management program', '258 participants (128 in the incentive group and 130 in the control group) had a mean (SD) age of 48.0 (10.5) years and mean (SD) body mass index of 32.1 (3.9); 225 (87.2%) were women; 235 (91.1%) were white; and 102 (39.5%) had an annual income of at least $100\u202f000']","['Escalating Financial Incentive Rewards', 'text messaging feedback']","['mean weight changes', 'weight change', 'weight change at the end of phase 2 and changes in self-reported physical activity and eating behaviors', 'Weight measurement', 'Mean weight changes', 'weight loss maintenance', 'Maintenance of Weight Loss', 'rates of self-weighing', 'mean self-weighing of at least 6 times']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",258.0,0.275239,"Compared with an active control condition of weekly messages, escalating lottery-based incentives transiently increased rates of self-weighing but did not significantly enhance weight loss maintenance.
","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Duke University Diet and Fitness Center, Durham, North Carolina.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Shaw', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reale', 'Affiliation': 'Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hilbert', 'Affiliation': 'Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jingsan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Department of Science, WW (formerly Weight Watchers), New York, New York.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14393']
1590,30367462,Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial.,"BACKGROUND
Nail psoriasis is associated with functional impairment, pain and reduced quality of life.
OBJECTIVES
To demonstrate the superiority of secukinumab over placebo in clearing nail psoriasis as assessed by the Nail Psoriasis Severity Index (NAPSI) at week 16 and over time up to week 132. Presented here is the week 32 interim analysis. Impact on quality of life was assessed by Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) patient questionnaires.
METHODS
TRANSFIGURE is a double-blind, randomized, placebo-controlled study in patients with moderate-to-severe plaque and nail psoriasis.
RESULTS
The primary objective of this study was met: both doses of secukinumab were superior to placebo at week 16 (NAPSI improvements of -45·3%, -37·9% and -10·8% for secukinumab 300 mg and 150 mg and placebo, respectively, P < 0·001). Significant improvements were seen in patients' quality of life: the NAPPA-Quality of Life total score median decreases at week 16 were 60·9%, 49·9% and 15·8% for secukinumab 300 mg and 150 mg and placebo, respectively (P < 0·001). Improvement in nail psoriasis continued to week 32: NAPSI percentage change reached -63·2% and -52·6% for secukinumab 300 mg and 150 mg, respectively. Skin clearance measured by ≥ 90% improvement in Psoriasis Area and Severity Index was significant (rates of 72·5%, 54·0% and 1·7% for secukinumab 300 mg and 150 mg and placebo at week 16, respectively, P < 0·001) and was sustained to week 32. The most common adverse events were nasopharyngitis, headache and upper respiratory tract infections.
CONCLUSIONS
Secukinumab demonstrated significant and clinically meaningful efficacy and quality-of-life improvements for patients with nail psoriasis up to week 32. What's already known about this topic? Nail psoriasis is understudied and there is a lack of effective treatment options. Nail psoriasis is correlated with more severe psoriatic disease and the development of psoriatic arthritis. What does this study add? TRANSFIGURE is one of the few prospective placebo-controlled trials specifically in nail psoriasis and includes nail-specific quality-of-life measures such as Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)-Quality of Life and NAPPA-Patient Benefit Index. In this trial, secukinumab demonstrates significant efficacy and quality-of-life improvements in this difficult-to-treat population.",2019,Significant improvements were seen in patients' quality of life:,"['Psoriasis and Psoriatic Arthritis (NAPPA) patient questionnaires', 'patients with nail psoriasis', 'patients with moderate-to-severe plaque and nail psoriasis']","['secukinumab 300 mg and 150 mg and placebo', 'secukinumab over placebo', 'secukinumab', 'placebo']","['Skin clearance', 'NAPPA-Quality of Life total score median decreases', 'Psoriasis Area and Severity Index', 'nasopharyngitis, headache and upper respiratory tract infections', 'quality of life', ""patients' quality of life"", 'nail psoriasis', 'meaningful efficacy and quality-of-life improvements', 'clinical activity and disease burden of nail psoriasis', 'Nail Psoriasis Severity Index (NAPSI']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail (disorder)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.138416,Significant improvements were seen in patients' quality of life:,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Dermatologikum Berlin, Friedrichstraße 89, 10117, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sullivan', 'Affiliation': 'Kingsway Dermatology & Aesthetics, Miranda, NSW, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Arenberger', 'Affiliation': 'Department of Dermatology, Charles University, Third Faculty of Medicine, Prague, Czech Republic.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jazayeri', 'Affiliation': 'Alliance Dermatology and Mohs Center, Phoenix, AZ, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Universität Hamburg, Hamburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Parneix', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, U.S.A.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Regnault', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'You', 'Affiliation': 'Beijing Novartis Pharma Co. Ltd, Beijing, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Milutinovic', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",The British journal of dermatology,['10.1111/bjd.17351']
1591,31820806,Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial.,"STUDY QUESTION
Is there a difference in functional outcomes and recurrence rate between conservative versus radical rectal surgery in patients with large deep endometriosis infiltrating the rectum 5 years postoperatively?
SUMMARY ANSWER
No evidence was found that long-term outcomes differed when nodule excision was compared to rectal resection for deeply invasive endometriosis involving the bowel.
WHAT IS KNOWN ALREADY
Functional outcomes of nodule excision and rectal resection for deeply invasive endometriosis involving the bowel are comparable 2 years after surgery. Despite numerous previously reported case series enrolling patients managed for colorectal endometriosis, long-term data remain scarce in the literature.
STUDY DESIGN, SIZE, DURATION
From March 2011 to August 2013, we performed a two-arm randomized trial, enrolling 60 patients with deep endometriosis infiltrating the rectum up to 15 cm from the anus, measuring >20 mm in length, involving at least the muscular layer in depth, and up to 50% of rectal circumference. Among them, 55 women were enrolled at one tertial referral centre in endometriosis, using a randomization list drawn up separately for this centre. Institute review board approval was obtained to continue follow-up to 10 years postoperatively. One patient requested to stop the follow-up 2 years after surgery.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Patients underwent either nodule excision by shaving or disc excision, or segmental resection. Randomization was performed preoperatively using sequentially numbered, opaque, sealed envelopes, and patients were informed of randomization results. The primary endpoint was the proportion of patients experiencing one of the following symptoms: constipation (1 stool/>5 consecutive days), frequent bowel movements (≥3 stools/day), anal incontinence, dysuria or bladder atony requiring self-catheterization 24 months postoperatively. Secondary endpoints were values taken from the Knowles-Eccersley-Scott-symptom questionnaire (KESS), the gastrointestinal quality of life index (GIQLI), the Wexner scale, the urinary symptom profile (USP) and the Short Form 36 Health Survey (SF36).
MAIN RESULTS AND THE ROLE OF CHANCE
Fifty-five patients were enrolled. Among the 27 patients in the excision arm, two were converted to segmental resection (7.4%). One patient managed by segmental resection withdrew from the study 2 years postoperatively, presuming that associated pain of other aetiologies may have jeopardized the outcomes. The 5 year-recurrence rate for excision and resection was 3.7% versus 0% (P = 1), respectively. For excision and resection, the primary endpoint was present in 44.4% versus 60.7% of patients (P = 0.29), respectively, while 55.6% versus 53.6% of patients subjectively reported normal bowel movements (P = 1). An intention-to-treat comparison of overall KESS, GIQLI, Wexner, USP and SF36 scores did not reveal significant differences between the two arms 5 years postoperatively. Statistically significant improvement was observed shortly after surgery with no further improvement or impairment recorded 1-5 years postoperatively. During the 5-year follow-up, additional surgical procedures were performed in 25.9% versus 28.6% of patients who had undergone excision or resection (P = 0.80), respectively.
LIMITATIONS, REASONS FOR CAUTION
The presumption of a 40% difference concerning postoperative functional outcomes in favour of nodule excision resulted in a lack of power for demonstration of the primary endpoint difference.
WIDER IMPLICATIONS OF THE FINDINGS
Five-year follow-up data do not show statistically significant differences between conservative and radical rectal surgery for long-term functional digestive and urinary outcomes in this specific population of women with large involvement of the rectum.
STUDY FUNDING/COMPETING INTEREST(S)
No specific funding was received. Patient enrolment and follow-up until 2 years postoperatively was supported by a grant from the clinical research programme for hospitals in France. The authors declare no competing interests related to this study.
TRIAL REGISTRATION NUMBER
This randomized study is registered with ClinicalTrials.gov, number NCT01291576.
TRIAL REGISTRATION DATE
31 January 2011.
DATE OF FIRST PATIENT’S ENROLMENT
7 March 2011.",2019,"The 5 year-recurrence rate for excision and resection was 3.7% versus 0% (P = 1), respectively.","['55 women were enrolled at one tertial referral centre in endometriosis, using a randomization list drawn up separately for this centre', '31 January 2011', 'Patients underwent either', '27 patients in the excision arm, two were converted to segmental resection (7.4', 'Fifty-five patients were enrolled', 'patients with large deep endometriosis infiltrating the rectum 5\xa0years postoperatively', '60 patients with deep endometriosis infiltrating the rectum up to 15\xa0cm from the anus, measuring >20\xa0mm in length, involving at least the muscular layer in depth, and up to 50% of rectal circumference', 'From March 2011 to August 2013', 'deep endometriosis infiltrating the rectum']","['nodule excision and rectal resection', 'nodule excision by shaving or disc excision, or segmental resection', 'Excision versus colorectal resection', 'radical rectal surgery']","['functional outcomes and recurrence rate', 'recurrence rate for excision and resection', 'frequent bowel movements (≥3 stools/day), anal incontinence, dysuria or bladder atony requiring self-catheterization 24\xa0months postoperatively', 'normal bowel movements', 'values taken from the Knowles-Eccersley-Scott-symptom questionnaire (KESS), the gastrointestinal quality of life index (GIQLI), the Wexner scale, the urinary symptom profile (USP) and the Short Form 36 Health Survey (SF36', 'proportion of patients experiencing one of the following symptoms: constipation', 'overall KESS, GIQLI, Wexner, USP and SF36 scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4510788', 'cui_str': 'Deep endometriosis'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003461', 'cui_str': 'Anus'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]","[{'cui': 'C2939022', 'cui_str': 'Nodule excision'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0239978', 'cui_str': 'Increased frequency of defecation (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0403645', 'cui_str': 'Acontractile detrusor (disorder)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.122253,"The 5 year-recurrence rate for excision and resection was 3.7% versus 0% (P = 1), respectively.","[{'ForeName': 'Horace', 'Initials': 'H', 'LastName': 'Roman', 'Affiliation': 'Endometriosis Center, Clinique Tivoli-Ducos, Bordeaux 33000, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Department of Surgery, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Huet', 'Affiliation': 'Department of Surgery, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Bridoux', 'Affiliation': 'Department of Surgery, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Khalil', 'Affiliation': 'Department of Surgery, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Hennetier', 'Affiliation': 'Expert Center in the Diagnosis and Multidisciplinary Management of Endometriosis, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bubenheim', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Lacramioara Aurelia', 'Initials': 'LA', 'LastName': 'Branduse', 'Affiliation': 'Department of Public Health and Management, Carol Davila University of Medicine and Pharmacy Bucharest, Romania.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez217']
1592,30593463,Longitudinal evaluation of SMN levels as biomarker for spinal muscular atrophy: results of a phase IIb double-blind study of salbutamol.,"BACKGROUND
Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disorder, due to the loss of function of the survival motor neuron ( SMN1 ) gene. The first treatment for the condition, recently approved, is based on the reduction of exon 7 skipping in mRNAs produced by a highly homologous gene ( SMN2 ). The primary objective of the present study was to evaluate the applicability of the dosage of SMN gene produts in blood, as biomarker for SMA, and the safety of oral salbutamol, a beta2-adrenergic agonist modulating SMN2 levels.
METHODS
We have performed a 1-year multicentre, double-blind, placebo-controlled study with salbutamol in 45 adult patients with SMA. Patients assumed 4 mg of salbutamol or placebo/three times a day. Molecular tests were SMN2 copy number, SMN transcript and protein levels. We have also explored the clinical effect, by the outcome measures available at the time of study design.
RESULTS
Thirty-six patients completed the study. Salbutamol was safe and well tolerated. We observed a significant and progressive increase in SMN2 full-length levels in peripheral blood of the salbutamol-treated patients (p<0.00001). The exploratory analysis of motor function showed an improvement in most patients.
CONCLUSIONS
Our data demonstrate safety and molecular efficacy of salbutamol. We provide the first longitudinal evaluation of SMN levels (both transcripts and protein) in placebo and in response to a compound modulating the gene expression: SMN transcript dosage in peripheral blood is reliable and may be used as pharmacodynamic marker in clinical trials with systemic compounds modifying SMN2 levels.
TRIAL REGISTRATION NUMBER
EudraCT no. 2007-001088-32.",2019,We observed a significant and progressive increase in SMN2 full-length levels in peripheral blood of the salbutamol-treated patients (p<0.00001).,"['spinal muscular atrophy', 'Thirty-six patients completed the study', '45 adult patients with SMA']","['placebo', 'EudraCT', 'salbutamol', 'salbutamol or placebo', 'Salbutamol']",['safe and well tolerated'],"[{'cui': 'C0026847', 'cui_str': 'Spinal Muscular Atrophy'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}]",[],45.0,0.141272,We observed a significant and progressive increase in SMN2 full-length levels in peripheral blood of the salbutamol-treated patients (p<0.00001).,"[{'ForeName': 'Francesco Danilo', 'Initials': 'FD', 'LastName': 'Tiziano', 'Affiliation': 'Institute of Genomic Medicine, Catholic University, Roma, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Lomastro', 'Affiliation': 'Institute of Genomic Medicine, Catholic University, Roma, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Abiusi', 'Affiliation': 'Institute of Genomic Medicine, Catholic University, Roma, Italy.'}, {'ForeName': 'Maria Barbara', 'Initials': 'MB', 'LastName': 'Pasanisi', 'Affiliation': 'Muscle Pathology and Neuroimmunology Unit, Neurological Institute Carlo Besta, Milano, Italy.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Di Pietro', 'Affiliation': 'Institute of Genomic Medicine, Catholic University, Roma, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Fiori', 'Affiliation': 'Institute of Genomic Medicine, Catholic University, Roma, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Baranello', 'Affiliation': 'Developmental Neurology Unit, Neurological Institute Carlo Besta, Milano, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Angelini', 'Affiliation': 'IRCCS Foundation S Camillo, Lido di Venezia, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Sorarù', 'Affiliation': 'Department of Neurosciences, University of Padova, Padua, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Gaiani', 'Affiliation': 'Department of Neurosciences, University of Padova, Padua, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Mongini', 'Affiliation': 'Neuromuscular Diseases Unit, Rita Levi Montalcini Department of Neuroscience, University of Torino, Torino, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Vercelli', 'Affiliation': 'Neuromuscular Diseases Unit, Rita Levi Montalcini Department of Neuroscience, University of Torino, Torino, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': 'Department of Pediatric Neurology, Catholic University, Roma, Italy.'}, {'ForeName': 'Gessica', 'Initials': 'G', 'LastName': 'Vasco', 'Affiliation': 'Department of Pediatric Neurology, Catholic University, Roma, Italy.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Pane', 'Affiliation': 'Department of Pediatric Neurology, Catholic University, Roma, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Vita', 'Affiliation': 'Cardiomyology and Medical Genetics Section, Second University of Campania Naples, Napoli, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Vita', 'Affiliation': 'Nemo Sud Clinical Centre, Messina, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Messina', 'Affiliation': 'Cardiomyology and Medical Genetics Section, Second University of Campania Naples, Napoli, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Petillo', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.'}, {'ForeName': 'Luigia', 'Initials': 'L', 'LastName': 'Passamano', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Politano', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Campanella', 'Affiliation': 'Muscle Pathology and Neuroimmunology Unit, Neurological Institute Carlo Besta, Milano, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Mantegazza', 'Affiliation': 'Muscle Pathology and Neuroimmunology Unit, Neurological Institute Carlo Besta, Milano, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Morandi', 'Affiliation': 'Muscle Pathology and Neuroimmunology Unit, Neurological Institute Carlo Besta, Milano, Italy.'}]",Journal of medical genetics,['10.1136/jmedgenet-2018-105482']
1593,30959314,Circulating endostatin as a risk factor for cardiovascular events in patients with stable coronary heart disease: A CLARICOR trial sub-study.,"BACKGROUND AND AIMS
Raised levels of serum endostatin, a biologically active fragment of collagen XVIII, have been observed in patients with ischemic heart disease but association with incident cardiovascular events in patients with stable coronary heart disease is uncertain.
METHODS
The CLARICOR-trial is a randomized, placebo-controlled trial of stable coronary heart disease patients evaluating 14-day treatment with clarithromycin. The primary outcome was a composite of acute myocardial infarction, unstable angina pectoris, cerebrovascular disease or all-cause mortality. In the present sub-study using 10-year follow-up data, we investigated associations between serum endostatin at entry (randomization) and the composite outcome and its components during follow-up. The placebo group was used as discovery sample (1204 events, n = 1998) and the clarithromycin-treated group as replication sample (1220 events, n = 1979).
RESULTS
In Cox regression models adjusting for cardiovascular risk factors, glomerular filtration rate, and current pharmacological treatment, higher serum endostatin was associated with an increased risk of the composite outcome in the discovery sample (hazard ratio per standard deviation increase 1.11, 95% CI 1.03-1.19, p = 0.004), but slightly weaker and not statistically significant in the replication sample (hazard ratio 1.06, 95% CI 1.00-1.14, p = 0.06). In contrast, strong and consistent associations were found between endostatin and cardiovascular and all-cause mortality in all multivariable models and sub-samples. Addition of endostatin to a model with established cardiovascular risk factors provided no substantial improvement of risk prediction (<1%).
CONCLUSIONS
Raised levels of serum endostatin might be associated with cardiovascular events in patients with stable coronary heart disease. The clinical utility of endostatin measurements remains to be established.",2019,"The primary outcome was a composite of acute myocardial infarction, unstable angina pectoris, cerebrovascular disease or all-cause mortality.","['stable coronary heart disease patients', 'patients with ischemic heart disease', 'patients with stable coronary heart disease']","['endostatin', 'clarithromycin-treated group as replication sample', 'placebo', 'clarithromycin']","['replication sample', 'cardiovascular risk factors, glomerular filtration rate, and current pharmacological treatment', 'endostatin and cardiovascular and all-cause mortality', 'serum endostatin', 'composite of acute myocardial infarction, unstable angina pectoris, cerebrovascular disease or all-cause mortality']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}]","[{'cui': 'C0534628', 'cui_str': 'Endostatins'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0534628', 'cui_str': 'Endostatins'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0007820', 'cui_str': 'Intracranial Vascular Disorders'}]",,0.132154,"The primary outcome was a composite of acute myocardial infarction, unstable angina pectoris, cerebrovascular disease or all-cause mortality.","[{'ForeName': 'Toralph', 'Initials': 'T', 'LastName': 'Ruge', 'Affiliation': 'Department of Emergency Medicine, Karolinska University Hospital, Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Axel C', 'Initials': 'AC', 'LastName': 'Carlsson', 'Affiliation': 'Division of Family Medicine and Primary Care, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden; Department of Medical Sciences, Cardiovascular Epidemiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kjøller', 'Affiliation': 'Department of Cardiology, Herlev Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hilden', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans Jørn', 'Initials': 'HJ', 'LastName': 'Kolmos', 'Affiliation': 'Department of Clinical Microbiology, Odense University Hospital, Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Copenhagen University Hospital of Bispebjerg & Frederiksberg, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Rigshospitalet of Copenhagen University, Denmark.'}, {'ForeName': 'Gorm Boje', 'Initials': 'GB', 'LastName': 'Jensen', 'Affiliation': 'Copenhagen University Hospital Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nowak', 'Affiliation': 'Division of Family Medicine and Primary Care, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Holbæk Hospital, Holbæk, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ärnlöv', 'Affiliation': 'Division of Family Medicine and Primary Care, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden; School of Health and Social Studies, Dalarna University, Falun, Sweden. Electronic address: johan.arnlov@ki.se.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2019.02.031']
1594,30518302,Sumter County on the Move! Evaluation of a Walking Group Intervention to Promote Physical Activity Within Existing Social Networks.,"BACKGROUND
Social network-driven approaches have promise for promoting physical activity in community settings. Yet, there have been few direct investigations of such interventions. This study tested the effectiveness of a social network-driven, group-based walking intervention in a medically underserved community.
METHODS
This study used a quasi-experimental pretest-posttest design with 3 measurement time points to examine the effectiveness of Sumter County on the Move! in communities in Sumter County, SC. A total of 293 individuals participated in 59 walking groups formed from existing social networks. Participants were 86% females, 67% black, and 31% white, with a mean age of 49.5 years. Measures included perceptions of the walking groups; psychosocial factors such as self-regulation, self-efficacy, and social support; and both self-reported and objectively measured physical activity.
RESULTS
The intervention produced significant increases in goal setting and social support for physical activity from multiple sources, and these intervention effects were sustained through the final measurement point 6 months after completion of the intervention. Nonetheless, few of the desired changes in physical activity were observed.
CONCLUSION
Our mixed results underscore the importance of future research to better understand the dose and duration of intervention implementation required to effect and sustain behavior change.",2018,"The intervention produced significant increases in goal setting and social support for physical activity from multiple sources, and these intervention effects were sustained through the final measurement point 6 months after completion of the intervention.","['Participants were 86% females, 67% black, and 31% white, with a mean age of 49.5 years', 'medically underserved community', '293 individuals participated in 59 walking groups formed from existing social networks']","['Walking Group Intervention', 'social network-driven, group-based walking intervention']","['physical activity', 'perceptions of the walking groups; psychosocial factors such as self-regulation, self-efficacy, and social support; and both self-reported and objectively measured physical activity', 'goal setting and social support for physical activity', 'Physical Activity']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}]",293.0,0.0147345,"The intervention produced significant increases in goal setting and social support for physical activity from multiple sources, and these intervention effects were sustained through the final measurement point 6 months after completion of the intervention.","[{'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Forthofer', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kinnard', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': ''}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Sharpe', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2017-0603']
1595,21957402,A randomized controlled trial to compare pregabalin with gabapentin for postoperative pain in abdominal hysterectomy.,"BACKGROUND
Pregabalin is a potent ligand for alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, which exhibits potent anticonvulsant, analgesic and anxiolytic activity. The pharmacological activity of pregabalin is similar to that of gabapentin and shows possible advantages. Although it shows analgesic efficacy against neuropathic pain, very limited evidence supports its postoperative analgesic efficacy. We investigated its analgesic efficacy in patients experiencing acute pain after abdominal hysterectomy and compared it with gabapentin and placebo.
METHODS
A randomized, double-blind, placebo-controlled study was conducted in 90 women undergoing abdominal hysterectomy who were anaesthetized in a standardized fashion. Patients received 300 mg pregabalin, 900 mg gabapentin or placebo, 1-2 hours prior to surgery. Postoperative analgesia was administered at visual analogue scale (VAS) ≥3. The primary outcome was analgesic consumption over 24 hours and patients were followed for pain scores, time to rescue analgesia and side effects as secondary outcomes.
RESULTS
The diclofenac consumption was statistically significant between pregabalin and control groups, and gabapentin and control groups; however, pregabalin and gabapentin groups were comparable. Moreover, the consumption of tramadol was statistically significant among all the groups. Patients in pregabalin and gabapentin groups had lower pain scores in the initial hour of recovery. However, pain scores were subsequently similar in all the groups. Time to first request for analgesia was longer in pregabalin group followed by gabapentin and control groups.
CONCLUSION
A single dose of 300 mg pregabalin given 1-2 hours prior to surgery is superior to 900 mg gabapentin and placebo after abdominal hysterectomy. Both the drugs are better than placebo.",2011,"The diclofenac consumption was statistically significant between pregabalin and control groups, and gabapentin and control groups; however, pregabalin and gabapentin groups were comparable.","['patients experiencing acute pain after abdominal hysterectomy and compared it with', '90 women undergoing abdominal hysterectomy who were anaesthetized in a standardized fashion', 'postoperative pain in abdominal hysterectomy']","['gabapentin or placebo', 'placebo', 'gabapentin and placebo', 'Pregabalin', 'pregabalin', 'gabapentin', 'pregabalin and gabapentin', 'pregabalin with gabapentin']","['analgesic efficacy', 'Postoperative analgesia', 'Time to first request for analgesia', 'lower pain scores', 'analgesic consumption', 'pain scores', 'consumption of tramadol', 'diclofenac consumption', 'pain scores, time to rescue analgesia and side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",90.0,0.510584,"The diclofenac consumption was statistically significant between pregabalin and control groups, and gabapentin and control groups; however, pregabalin and gabapentin groups were comparable.","[{'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Ghai', 'Affiliation': 'Department of Anaesthesiology & Critical Care, Pt. BDS Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Sarla', 'Initials': 'S', 'LastName': 'Hooda', 'Affiliation': ''}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Singla', 'Affiliation': ''}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Wadhera', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.84097']
1596,30601581,Reduction of Cortical Bone Turnover and Erosion Depth After 2 and 3 Years of Denosumab: Iliac Bone Histomorphometry in the FREEDOM Trial.,"Denosumab, a RANKL inhibitor, reduced the risk of vertebral, hip, and nonvertebral fractures in the Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months (FREEDOM) trial of postmenopausal women with osteoporosis compared with placebo. Previous bone histomorphometric analysis in FREEDOM showed decreased bone resorption and turnover in cancellous bone after 2 and 3 years. The purpose of the present study was to evaluate the effects of denosumab compared with placebo in the cortical compartment from transiliac bone biopsies obtained during FREEDOM. A total of 112 specimens were evaluable for cortical histomorphometry, including 67 obtained at month 24 (37 placebo, 30 denosumab) and 45 at month 36 (25 placebo, 20 denosumab). Eroded surface, osteoclast surface, erosion depth, and wall thickness were measured on the endocortical surface. Cortical thickness and cortical porosity were also measured. Dynamic parameters of bone formation were assessed for endocortical, periosteal, and intracortical envelopes. Endocortical osteoclast surface, eroded surface, and mean and maximum erosion depth were significantly lower in the denosumab group versus placebo at months 24 and 36 (p < 0.0001 to p = 0.04). Endocortical wall thickness and intracortical measures (cortical porosity and cortical thickness) were not different between the two groups. Dynamic parameters were low with tetracycline labels in cortical bone observed in 13 (43%) and 10 (50%) of denosumab biopsies at months 24 and 36, respectively, reflecting a marked decrease in bone turnover. In conclusion, our data reveal the mechanism of action of denosumab on cortical bone: inhibition of osteoclastic resorption and reduced activation of new remodeling sites. In addition, reduced endocortical erosion depth with no change of wall thickness may contribute to increased bone strength by reducing the bone loss and fragility associated with deep resorption cavities and may likely contribute to the greater BMD gain with denosumab than with other antiresorptive agents. © 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc.",2019,Endocortical wall thickness and intracortical measures (cortical porosity and cortical thickness) were not different between the two groups.,"['A total of 112 specimens were evaluable for cortical histomorphometry, including 67 obtained at month 24 (37 placebo, 30 denosumab) and 45 at month 36 (25 placebo, 20 denosumab', 'postmenopausal women with osteoporosis']","['Denosumab', 'placebo', 'tetracycline labels', 'denosumab', 'Denosumab: Iliac Bone Histomorphometry']","['cortical bone', 'Cortical Bone Turnover and Erosion Depth', 'bone strength', 'Endocortical wall thickness and intracortical measures (cortical porosity and cortical thickness', 'bone formation', 'BMD gain', 'Cortical thickness and cortical porosity', 'bone turnover', 'Endocortical osteoclast surface, eroded surface, and mean and maximum erosion depth', 'Eroded surface, osteoclast surface, erosion depth, and wall thickness', 'bone resorption and turnover in cancellous bone']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039651', 'cui_str': 'Tetracyclines'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}]","[{'cui': 'C0222652', 'cui_str': 'Cortex of bone (body structure)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0080037', 'cui_str': 'Porosity'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0029431', 'cui_str': 'Osteoclasts'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}]",112.0,0.0419879,Endocortical wall thickness and intracortical measures (cortical porosity and cortical thickness) were not different between the two groups.,"[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Chavassieux', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Portero-Muzy', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Jean Paul', 'Initials': 'JP', 'LastName': 'Roux', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Horlait', 'Affiliation': 'Amgen, Boulogne Billancourt, France.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dempster', 'Affiliation': 'Department of Pathology and Cell Biology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Wagman', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Chapurlat', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3631']
1597,29522149,Patient-Reported Dysphagia After Thyroidectomy: A Qualitative Study.,"Importance
It is important that clinicians understand consequences of thyoridectomy on swallowing from the patient perspective to better care for this population.
Objective
Using rigorous qualitative methodology, this study set out to characterize the effect of swallowing-related symptoms after thyroidectomy on patient quality of life and swallowing-related outcomes.
Design, Setting, and Participants
Prospective, grounded theory analysis of interviews with 26 patients at 3 time points after thyroidectomy (2 weeks, 6 weeks, and 6 months). Data were collected from an ongoing clinical trial (NCT02138214), and outpatient interviews were conducted at the University of Wisconsin Hospital and Clinics. All participants were age 21 to 73 years with a diagnosis of papillary thyroid cancer without cervical or distant metastases and had undergone total thyroidectomy. Exclusion criteria were preexisting vocal fold abnormalities (eg, polyps, nodules), neurological conditions affecting the voice or swallowing ability, and/or development of new-onset vocal fold paresis or paralysis (lasting longer than 6 months) after total thyroidectomy.
Interventions
Total thyroidectomy.
Main Outcomes and Measures
Symptoms of dysphagia and related effects on quality of life elicited through grounded theory analysis of semistructured interviews with patients after thyroidectomy designed to foster an open-ended, patient-driven discussion.
Results
Of the 26 patients included, 69% were women (n = 18); mean (SD) age, 46.4 (14.1) years; mean (SD) tumor diameter 2.2 (1.4) cm. Two weeks after thyroidectomy, 80% of participants (n = 20) reported at least 1 swallowing-related symptom when prompted by the interview cards; during the open interview, 53% of participants (n = 14) volunteered discussion of swallowing-related symptoms unprompted. However, only 8% of participants in this study (n = 2) qualified for a follow-up dysphagia evaluation, indicating that the majority of reported symptoms were subjective in nature. Six weeks and 6 months after thyroidectomy, 42% (n = 11) and 17% (n = 4) of participants, respectively, reported continued swallowing symptoms using the prompts; 12% (n = 3) discussed symptoms without prompting cards at both time points.
Conclusions and Relevance
Swallowing symptoms after thyroidectomy are underreported in the literature. This study revealed that as many as 80% of patients who have thyroidectomy may experience swallowing-related symptoms after surgery, and many develop compensatory strategies to manage or reduce the burden of these symptoms. Considering the large number of individuals who may experience subjective dysphagia, preoperative counseling should include education and management of such symptoms.",2018,"Two weeks after thyroidectomy, 80% of participants (n = 20) reported at least 1 swallowing-related symptom when prompted by the interview cards; during the open interview, 53% of participants (n = 14) volunteered discussion of swallowing-related symptoms unprompted.","['26 patients included', 'All participants were age 21 to 73 years with a diagnosis of papillary thyroid cancer without cervical or distant metastases and had undergone total thyroidectomy', 'Exclusion criteria were preexisting vocal fold abnormalities (eg, polyps, nodules), neurological conditions affecting the voice or swallowing ability, and/or development of new-onset vocal fold paresis or paralysis (lasting longer than 6 months) after total thyroidectomy', 'mean (SD) age, 46.4 (14.1) years; mean (SD) tumor diameter 2.2 (1.4) cm', ' 69% were women (n\u2009=\u200918']",[],"['continued swallowing symptoms', 'Dysphagia', 'quality of life elicited through grounded theory analysis of semistructured interviews with patients after thyroidectomy designed to foster an open-ended, patient-driven discussion', 'patient quality of life and swallowing-related outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0238463', 'cui_str': 'Thyroid Cancer, Papillary'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0030552', 'cui_str': 'Muscular Paresis'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0426601', 'cui_str': 'Swallowing symptoms (finding)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0034380'}, {'cui': 'C1510611', 'cui_str': 'Grounded Theory'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0484114,"Two weeks after thyroidectomy, 80% of participants (n = 20) reported at least 1 swallowing-related symptom when prompted by the interview cards; during the open interview, 53% of participants (n = 14) volunteered discussion of swallowing-related symptoms unprompted.","[{'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Krekeler', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin, Madison.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wendt', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Macdonald', 'Affiliation': 'Qualitative Health Research Consultants, Madison, Wisconsin.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Orne', 'Affiliation': 'Department of Sociology, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Francis', 'Affiliation': 'Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, University of Wisconsin, Madison.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sippel', 'Affiliation': 'Wisconsin Surgical Outcomes Research Program, Madison.'}, {'ForeName': 'Nadine P', 'Initials': 'NP', 'LastName': 'Connor', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin, Madison.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2017.3378']
1598,31166287,Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension.,"PRéCIS:: Noninferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared with a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension.
PURPOSE
The purpose of this study was to compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension.
METHODS
Phase III, randomized, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged 18 years or older with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7±2.4 mm Hg overall before inclusion) were randomized at day 0 with no washout period to receive the preservative-free alternative T2347 (N=127) or remain on the preserved comparator (N=115) for 84 days. Intraocular pressure changes from day 0 were measured at 9:00 am (±1 hour) on day 42 and day 84, and noninferiority of T2347 to the preserved comparator was analyzed statistically at day 84. Safety parameters were also reported.
RESULTS
The mean change in intraocular pressure from baseline to day 84 was -0.49±1.80 mm Hg for preservative-free T2347 and -0.49±2.25 mm Hg for the preserved comparator. These results met the noninferiority limits. Similar results were observed at day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84.
CONCLUSIONS
Preservative-free latanoprost-timolol fixed combination T2347 showed noninferior efficacy compared with the preserved comparator and was well tolerated.",2019,"The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84.
","['242 patients aged 18 years or older with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved', '15.7±2.4\u2009mm\u2009Hg overall before inclusion', 'Patients With Open-angle Glaucoma or Ocular Hypertension', '10 countries', 'patients with open-angle glaucoma or ocular hypertension']","['Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops', 'BAK-containing formulation', 'preservative-free alternative T2347 (N=127) or remain on the preserved comparator', 'Preservative-free latanoprost-timolol', 'preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination', 'latanoprost-timolol fixed combination', 'preservative-free latanoprost-timolol fixed combination']","['incidence of adverse events or ocular signs', 'tolerated', 'Intraocular pressure changes', 'noninferior efficacy', 'individual symptoms such as irritation/burning/stinging', 'mean change in intraocular pressure', 'total ocular symptoms score', 'intraocular pressure and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0005026', 'cui_str': 'Benzalkonium Chloride'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",242.0,0.207138,"The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84.
","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Aptel', 'Affiliation': 'CHU de Grenoble/University Hospital of Grenoble, Université Grenoble Alpes, Grenoble.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Ophthalmology, Mainz University Medical Center, Mainz.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schmickler', 'Affiliation': 'Augen-Zentrum-Nordwest, Augenpraxis Ahaus, Ahaus, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Cosme', 'Initials': 'C', 'LastName': 'Lavín-Dapena', 'Affiliation': 'Hospital Universitario La Paz, Madrid.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Moreno-Montañés', 'Affiliation': 'Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Żarnowski', 'Affiliation': 'Department of Diagnostics and Microsurgery of Glaucoma, Medical University, Lublin, Poland.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Csutak', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Jugaste', 'Affiliation': 'Clinic of Ophthalmology, Tallinn, Estonia.'}, {'ForeName': 'Lāsma', 'Initials': 'L', 'LastName': 'Volksone', 'Affiliation': ""Dr Volksone's Practice in Ophthalmology, Lavolks Ltd, Ri[Combining Macron]ga, Latvia.""}, {'ForeName': 'Yury S', 'Initials': 'YS', 'LastName': 'Astakhov', 'Affiliation': 'Department of Ophthalmology, Academician I.P. Pavlov First St. Petersburg State Medical University, St. Petersburg, Russia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Coupier', 'Affiliation': ""Centre Hospitalier du Pays d'Aix, Service Ophtalmologie, Aix-en-Provence.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Nordmann', 'Affiliation': 'Ophthalmology, CHNO des Quinze-Vingts, Paris, France.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Stalmans', 'Affiliation': 'Department of Ophthalmology, University Hospitals UZ Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001248']
1599,30291012,Effects of Intensive Blood Pressure Lowering on Kidney Tubule Injury in CKD: A Longitudinal Subgroup Analysis in SPRINT.,"BACKGROUND
Random assignment to the intensive systolic blood pressure (SBP) arm (<120mmHg) in the Systolic Blood Pressure Intervention Trial (SPRINT) resulted in more rapid declines in estimated glomerular filtration rates (eGFRs) than in the standard arm (SBP<140mmHg). Whether this change reflects hemodynamic effects or accelerated intrinsic kidney damage is unknown.
STUDY DESIGN
Longitudinal subgroup analysis of clinical trial participants.
SETTINGS & PARTICIPANTS
Random sample of SPRINT participants with prevalent chronic kidney disease (CKD) defined as eGFR<60mL/min/1.73m 2 by the CKD-EPI (CKD Epidemiology Collaboration) creatinine-cystatin C equation at baseline.
OUTCOMES & MEASUREMENTS
Urine biomarkers of tubule function (β 2 -microglobulin [B2M], α 1 -microglobulin [A1M]), and uromodulin), injury (interleukin 18, kidney injury molecule 1, and neutrophil gelatinase-associated lipocalin), inflammation (monocyte chemoattractant protein 1), and repair (human cartilage glycoprotein 40) at baseline, year 1, and year 4. Biomarkers were indexed to urine creatinine concentration and changes between arms were evaluated using mixed-effects linear models and an intention-to-treat approach.
RESULTS
978 SPRINT participants (519 in the intensive and 459 in the standard arm) with prevalent CKD were included. Mean age was 72±9 years and eGFR was 46.1±9.4mL/min/1.73m 2 at baseline. Clinical characteristics, eGFR, urinary albumin-creatinine ratio, and all 8 biomarker values were similar across arms at baseline. Compared to the standard arm, eGFR was lower by 2.9 and 3.3mL/min/1.73m 2 in the intensive arm at year 1 and year 4. None of the 8 tubule marker levels was higher in the intensive arm compared to the standard arm at year 1 or year 4. Two tubule function markers (B2M and A1M) were 29% (95% CI, 10%-43%) and 24% (95% CI, 10%-36%) lower at year 1 in the intensive versus standard arm, respectively.
LIMITATIONS
Exclusion of persons with diabetes, and few participants had advanced CKD.
CONCLUSIONS
Among participants with CKD in SPRINT, random assignment to the intensive SBP arm did not increase any levels of 8 urine biomarkers of tubule cell damage despite loss of eGFR. These findings support the hypothesis that eGFR declines in the intensive arm of SPRINT predominantly reflect hemodynamic changes rather than intrinsic damage to kidney tubule cells.",2019,None of the 8 tubule marker levels was higher in the intensive arm compared to the standard arm at year 1 or year 4.,"['Random sample of SPRINT participants with prevalent chronic kidney disease (CKD) defined as eGFR<60mL/min/1.73m 2 by the CKD-EPI (CKD Epidemiology Collaboration) creatinine-cystatin C equation at baseline', 'Kidney Tubule Injury in CKD', 'persons with diabetes, and few participants had advanced CKD', '978 SPRINT participants (519 in the intensive and 459 in the standard arm) with prevalent CKD were included', 'Longitudinal subgroup analysis of clinical trial participants']",['Intensive Blood Pressure Lowering'],"['tubule function markers (B2M and A1M', 'Clinical characteristics, eGFR, urinary albumin-creatinine ratio, and all 8 biomarker values', 'Urine biomarkers of tubule function (β 2 -microglobulin [B2M', 'eGFR', 'levels of 8 urine biomarkers of tubule cell damage despite loss of eGFR', 'uromodulin), injury (interleukin 18, kidney injury molecule 1, and neutrophil gelatinase-associated lipocalin), inflammation (monocyte chemoattractant protein 1), and repair (human cartilage glycoprotein 40', 'intensive systolic blood pressure (SBP']","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0022674', 'cui_str': 'Kidney Tubules'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042037'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",978.0,0.262057,None of the 8 tubule marker levels was higher in the intensive arm compared to the standard arm at year 1 or year 4.,"[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Imperial Valley Family Care Medical Group, El Centro, CA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craven', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology, Department of Medicine, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Internal Medicine, University of Utah; Medical Service, Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Medicine, University of Colorado, Denver, CO.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Division of General Internal Medicine, San Francisco VA Medical Center, San Francisco, CA; Kidney Health Research Collaborative, San Francisco VA Medical Center and University of California, San Francisco, CA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA; Nephrology Section, Veterans Affairs San Diego Healthcare System, La Jolla, CA. Electronic address: joeix@ucsd.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2018.07.015']
1600,27194545,Impact of Telephone-Based Care Coordination on Use of Cessation Medications Posthospital Discharge: A Randomized Controlled Trial.,"Introduction
Smokers benefit from ongoing cessation support upon leaving the hospital and returning to their home environment. This study examined the impact of telephone-delivered care coordination on utilization of and adherence to cessation pharmacotherapy after hospital discharge.
Methods
Inpatient smokers (n = 606) were randomized to receive counseling with care coordination (CCC) or counseling alone (C) for smoking cessation. Both groups received written materials and telephone-based cessation counseling during hospitalization and postdischarge. CCC recipients received help in selecting, obtaining, and refilling affordable pharmacotherapy prescriptions during and after hospitalization. Study outcomes included self-reported utilization, duration of use, and type of medication during the 3 months postdischarge.
Results
Of the 487 (80%) of participants completing 3-month follow-up, 211 (43.3%) reported using cessation pharmacotherapy postdischarge; this did not differ by study arm (CCC: 44.7%, C: 42.0%, p = .55). Use of pharmacotherapy postdischarge was associated with smoking at least 20 cigarettes/day at baseline (odds ratio [OR]: 1.48; 95% confidence interval [CI]: 1.00-2.19) and receipt of pharmacotherapy during hospitalization (OR: 4.00; 95% CI: 2.39-6.89). Smokers with Medicaid (OR: 2.29; 95% CI: 1.32-4.02) or other insurance (OR: 1.69; 95% CI: 1.01-2.86) were more likely to use pharmacotherapy postdischarge than those with no health care coverage. Less than one in four (23.8% of CCC; 22.2% of C) continued pharmacotherapy beyond 4 weeks.
Conclusions
Supplemental care coordination did not improve use of postdischarge pharmacotherapy beyond that of inpatient treatment and behavioral counseling. Insurance coverage and use of medications during the hospitalization are associated with higher use of evidence-based treatment postdischarge.
Implications
Many hospitalized smokers do not receive the benefits of cessation pharmacotherapy postdischarge and telephone quitline programs often fail to help smokers procure pharmacotherapy. Thus, effective strategies are needed to improve utilization and adherence to evidence-based cessation therapies when smokers leave the hospital. We found that use of postdischarge pharmacotherapy was strongly associated with receipt of pharmacotherapy during the hospitalization and with the availability of insurance to cover the costs of treatment. Additional efforts to coordinate pharmacotherapy services did not improve either utilization or adherence to therapy.",2017,"Insurance coverage and use of medications during the hospitalization are associated with higher use of evidence-based treatment postdischarge.
","['Many hospitalized smokers', 'Cessation Medications Posthospital Discharge', 'Methods\n\n\nInpatient smokers (n = 606']","['telephone-delivered care coordination', 'counseling with care coordination (CCC) or counseling alone (C) for smoking cessation', 'telephone quitline programs', 'CCC', 'Telephone-Based Care Coordination', 'written materials and telephone-based cessation counseling']","['self-reported utilization, duration of use, and type of medication during the 3 months postdischarge', 'cessation pharmacotherapy postdischarge']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",606.0,0.0451026,"Insurance coverage and use of medications during the hospitalization are associated with higher use of evidence-based treatment postdischarge.
","[{'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Tague', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Keighley', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Tresza', 'Initials': 'T', 'LastName': 'Hutcheson', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntw138']
1601,30561711,"Blinding and Patient-Reported Outcome Completion Rates in US Food and Drug Administration Cancer Trial Submissions, 2007-2017.","BACKGROUND
Patient-reported outcomes (PROs) are commonly included in submissions to the United States Food and Drug Administration (FDA). Open-label designs are frequent in cancer trials. Between-arm differences in PRO missingness may affect results. We sought to compare PRO completion rates between study arms in randomized open-label and double-blind cancer trials.
METHODS
Randomized, controlled trials for oncology and malignant hematology products submitted to the FDA in fiscal years 2007-2017 were identified using internal FDA databases. Applicant study reports were reviewed to assess PRO use and reporting of completion rates. Completion rates were collected for each PRO and compared between arms. Results were summarized using descriptive statistics.
RESULTS
Ninety-six trials for anticancer products from 2007 to 2017 contained PROs. Fifty-one (53.1%) were randomized, controlled trials with useable information on PRO completion. The median completion rate for investigational arms was 89.7% (range = 33.7-100.0%) and 88.2% (range = 11.0-100.0%) for control arms. At six months, seven double-blind trials had gaps of at least 10% in at least one PRO between arms; in four trials, these gaps favored the control arm (median difference = 11.5%, range = 10.0-17.0%). For open-label trials, four trials had such gaps, all of which favored the investigational arm (median difference = 28.5%, range = 10.0-69.0%).
CONCLUSIONS
Among trials that provided interpretable PRO completion information, completion rates were high. Most trials had comparable completion rates between arms. However, when large between-arm completion rate differences existed, differences favoring the experimental arm were more common in open-label trials compared with double-blind trials. Procedures must be put in place to improve reporting of PRO completion and reduce missingness, particularly in open-label trials.",2019,The median completion rate for investigational arms was 89.7% (range = 33.7-100.0%) and 88.2% (range = 11.0-100.0%) for control arms.,"['Ninety-six trials for anticancer products from 2007 to 2017 contained PROs', 'oncology and malignant hematology products submitted to the FDA in fiscal years 2007-2017 were identified using internal FDA databases', 'Fifty-one (53.1']",[],"['Completion rates', 'PRO completion rates', 'PRO use and reporting of completion rates', 'median completion rate']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.580763,The median completion rate for investigational arms was 89.7% (range = 33.7-100.0%) and 88.2% (range = 11.0-100.0%) for control arms.,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Roydhouse', 'Affiliation': 'Oak Ridge Institute for Science and Education (ORISE) Fellow, Silver Spring, MD.'}, {'ForeName': 'Bellinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'Office of Hematology and Oncology Products, Silver Spring, MD.'}, {'ForeName': 'Lynn J', 'Initials': 'LJ', 'LastName': 'Howie', 'Affiliation': 'Office of Hematology and Oncology Products, Silver Spring, MD.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Office of Hematology and Oncology Products, Silver Spring, MD.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djy181']
1602,31661171,A randomized comparison of manual pressure versus figure-of-eight suture for hemostasis after cryoballoon ablation for atrial fibrillation.,"INTRODUCTION
Cryoballoon ablation is commonly used to treat atrial fibrillation (AF). Femoral vein hemostasis after cryoballoon ablation for AF is routinely achieved with manual pressure (MP) after reversal of heparin and reassessment of the activated clotting time, or with a figure-of-eight suture (F8). The purpose of this randomized trial was to compare these two techniques for femoral vein hemostasis after cryoballoon ablation for AF in a patient population predominantly on novel anticoagulants (NOAC).
METHODS AND RESULTS
Seventy consecutive patients who underwent cryoballoon ablation were randomized to either the MP or F8 for femoral vein hemostasis. Clinical and procedural characteristics were similar between the groups with the majority of patients treated with a NOAC. The total time in the electrophysiology laboratory for the MP group and the F8 group (197 ± 37 minutes vs 167 ± 36 minutes, respectively; P = .02), and the time from sheath removal until the patient left the laboratory (28 ± 9 minutes vs 20 ± 5 minutes, respectively; P < .0001) were significantly less in the F8 group. Additional pressure for hemostasis in the recovery suite was required more often in the MP Group, as opposed to the F8 group (29% vs 3%; P = .003). No major bleeding occurred and the rate of minor hematomas was statistically similar.
CONCLUSIONS
Hemostasis obtained with a F8 suture after cryoballoon ablation for AF is associated with significantly less patient time in the electrophysiology laboratory, and an improved safety profile, compared with manual hemostasis, even amongst patients treated with a NOAC.",2019,"CONCLUSIONS
Hemostasis obtained with a F8 suture after cryoballoon ablation for AF is associated with significantly less patient time in the electrophysiology laboratory, and an improved safety profile, compared to manual hemostasis, even amongst patients treated with a NOAC.","['AF in a patient population predominantly on novel anticoagulants (NOAC', 'Seventy consecutive patients who underwent cryoballoon ablation', 'Atrial Fibrillation']","['femoral vein hemostasis after cryoballoon ablation', 'MP or F8 for femoral vein hemostasis', 'Manual Pressure versus Figure of Eight Suture for Hemostasis after Cryoballoon Ablation']","['total time', 'rate of minor hematomas', 'major bleeding', 'Additional pressure for hemostasis', 'time from sheath removal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0642228', 'cui_str': 'NOAC'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0015809', 'cui_str': 'Femoral vein structure'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",70.0,0.0663612,"CONCLUSIONS
Hemostasis obtained with a F8 suture after cryoballoon ablation for AF is associated with significantly less patient time in the electrophysiology laboratory, and an improved safety profile, compared to manual hemostasis, even amongst patients treated with a NOAC.","[{'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Wish', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Venkataraman', 'Affiliation': 'Department of Electrophysiology, Colorado Heart & Vascular, Lakewood, Colorado.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bliden', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}, {'ForeName': 'Manila', 'Initials': 'M', 'LastName': 'Jindal', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Strickberger', 'Affiliation': 'Department of Electrophysiology, INOVA Heart and Vascular Institute, INOVA Fairfax Hospital, Fairfax, Virginia.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14252']
1603,30356343,Use of Paracervical Block Before Laparoscopic Supracervical Hysterectomy.,"Background and Objective
Some patients who undergo laparoscopic hysterectomy request overnight admission for pain management, thus increasing costs for a surgery that is safe for same-day discharge. We wanted to evaluate whether a paracervical block of bupivacaine with epinephrine before laparoscopic supracervical hysterectomy would decrease overnight admission rates, postoperative pain, and pain medication requirement.
Methods
This was a randomized, double-blind, placebo-controlled, parallel-group trial (Canadian Task Force classification I) at an academic medical center. Patients undergoing laparoscopic supracervical hysterectomy were randomized to a 20-mL paracervical injection of either 0.25% bupivacaine with epinephrine or 20 mL normal saline before skin incision. All providers, except the circulating nurse, were blinded. The primary outcome was overnight hospital admission rate. Secondary outcomes included postoperative pain medication use and pain scores. Analysis included t test, χ 2 , Wilcoxon, and ANOVA.
Results
One hundred thirty-two patients were enrolled-68 in the treatment group and 64 in the placebo group. Demographics were similar between groups. The unplanned overnight admission rate was 34% for the treatment group and 27% for the placebo group ( P = .25). After discharge, the treatment group used on average 8.5 tablets of narcotics, whereas the placebo group used 11.7 tablets ( P = .07). The treatment group took 13.1 tablets of nonnarcotic analgesics compared to 11.2 in the placebo group ( P = .57). Both groups reported similar pain scores.
Conclusion
Paracervical block with bupivacaine and epinephrine before laparoscopic supracervical hysterectomy did not decrease overnight admission rate or affect postoperative pain. Postoperative opiate use was minimally decreased.",2018,The unplanned overnight admission rate was 34% for the treatment group and 27% for the placebo group ( P = .25).,['Patients undergoing laparoscopic supracervical hysterectomy'],"['bupivacaine with epinephrine', 'placebo', 'nonnarcotic analgesics', 'bupivacaine and epinephrine', '20-mL paracervical injection of either 0.25% bupivacaine with epinephrine or 20 mL normal saline before skin incision', 'Paracervical Block Before Laparoscopic Supracervical Hysterectomy']","['overnight hospital admission rate', 'unplanned overnight admission rate', 't test, χ 2 , Wilcoxon, and ANOVA', 'overnight admission rates, postoperative pain, and pain medication requirement', 'pain scores', 'Postoperative opiate use', 'postoperative pain medication use and pain scores', 'overnight admission rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404091', 'cui_str': 'Laparoscopic supracervical hysterectomy (procedure)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0030401', 'cui_str': 'Paracervical Block'}, {'cui': 'C0404091', 'cui_str': 'Laparoscopic supracervical hysterectomy (procedure)'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0002780', 'cui_str': 'ANOVA'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",132.0,0.686969,The unplanned overnight admission rate was 34% for the treatment group and 27% for the placebo group ( P = .25).,"[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Barr Grzesh', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Science, Division of Gynecology.'}, {'ForeName': 'Alejandro D', 'Initials': 'AD', 'LastName': 'Treszezamsky', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Science, Division of Gynecology.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Fenske', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Science, Division of Gynecology.'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Rascoff', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Science, Division of Gynecology.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Moshier', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ascher-Walsh', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Science, Division of Gynecology.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2018.00023']
1604,31604061,Subcutaneous Injection of Hyaluronic Acid to Decrease Acute Skin Toxicity After Adjuvant Interstitial Brachytherapy in Parotid Gland Cancer Patients: A Nonrandomized Controlled Trial.,"PURPOSE
The aim was to evaluate the safety and efficacy of subcutaneous injection of hyaluronic acid in decreasing acute skin toxicity after adjuvant interstitial brachytherapy in parotid gland cancer patients.
MATERIALS AND METHODS
Patients with histologically proven parotid gland cancer who would be treated with adjuvant interstitial brachytherapy were included in this nonrandomized controlled trial. Participants were nonrandomly divided into the experimental group and control group. Participants in the experimental group received an injection of hyaluronic acid subcutaneously immediately after interstitial brachytherapy during the operation. Acute toxicity was evaluated in the first 2 months.
RESULTS
Thirty consecutive participants were included from April to September 2018. Twenty participants were in the experimental group, and 10 were in the control group. The median volume of hyaluronic acid was 8 mL (range, 4 to 11 mL). In total, the incidence of acute skin toxicity was 40% (8 of 20 patients) and 100% (10 of 10 patients) in the experimental group and control group, respectively. The difference in the dose delivered to 90% of the target volume of the affected skin was significant between the pre-plan (mean, 36.93 Gy) and the actuarial quality verification (mean, 27.70 Gy) in the experimental group (P = .004). The difference in scoring of acute skin toxicity was significant between the experimental and control groups (P = .001). No clear correlation was found between the dose delivered to 90% of the target volume of the affected skin and the scoring of acute skin toxicity (P = .266).
CONCLUSIONS
Subcutaneous injection of hyaluronic acid was safe and efficient in decreasing acute skin toxicity after adjuvant interstitial brachytherapy in parotid gland cancer patients according to the preliminary results.",2020,The difference in scoring of acute skin toxicity was significant between the experimental and control groups (P = .001).,"['parotid gland cancer patients', 'Patients with histologically proven parotid gland cancer who would be treated with', 'Thirty consecutive participants were included from April to September 2018', 'Twenty participants were in the experimental group, and 10 were in the control group', 'Parotid Gland Cancer Patients']","['Adjuvant Interstitial Brachytherapy', 'hyaluronic acid', 'Hyaluronic Acid', 'adjuvant interstitial brachytherapy']","['median volume of hyaluronic acid', 'scoring of acute skin toxicity', 'actuarial quality verification', 'acute skin toxicity', 'Acute toxicity', 'Acute Skin', 'Toxicity', 'safety and efficacy']","[{'cui': 'C0030580', 'cui_str': 'Parotid Gland'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303135', 'cui_str': '10Be radioisotope'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1881237', 'cui_str': 'Interstitial brachytherapy (procedure)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",20.0,0.0366925,The difference in scoring of acute skin toxicity was significant between the experimental and control groups (P = .001).,"[{'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': 'Attending Physician, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Shu-Ming', 'Initials': 'SM', 'LastName': 'Liu', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China. Electronic address: kqlsm@126.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Huang', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.005']
1605,31665303,Isolating red flags to enhance diagnosis (I-RED): An experimental vignette study.,"OBJECTIVE
To investigate effects of a cognitive intervention based on isolation of red flags (I-RED) on diagnostic accuracy of 'do-not-miss diagnoses.'
DESIGN
A 2 × 2 randomized case vignette-based experiment with manipulation of I-RED strategy between subjects and case complexity within subjects.
SETTING
Two university-based residency programs.
PARTICIPANTS
One-hundred and nine pediatric residents from all levels of training.
INTERVENTIONS
Participants were randomly assigned to the I-RED vs. control group, and within each group, they were further randomized to the order in which they saw simple and complex cases. The I-RED strategy involved an instruction to look for a constellation of symptoms, signs, clinical data or circumstances that should heighten suspicion for a serious condition.
MAIN OUTCOME MEASURES
Primary outcome was diagnostic accuracy, scored as 1 if any of the three differentials given by participants included the correct diagnosis, and 0 if not. We analyzed effects of I-RED strategy on diagnostic accuracy using logistic regression.
RESULTS
I-RED strategy did not yield statistically higher diagnostic accuracy compared to controls (62 vs. 48%, respectively; odd ratio = 2.07 [95% confidence interval, 0.78-5.5], P = 0.14) although participants reported higher decision confidence compared to controls (7.00 vs. 5.77 on a scale of 1 to 10, P < 0.02) in simple but not complex cases. I-RED strategy significantly shortened time to decision (460 vs. 657 s, P < 0.001) and increased the number of red flags generated (3.04 vs. 2.09, P < 0.001).
CONCLUSIONS
A cognitive strategy of prompting red flag isolation prior to differential diagnosis did not improve diagnostic accuracy of 'do-not-miss diagnoses.' Given the paucity of evidence-based solutions to reduce diagnostic error and the intervention's potential effect on confidence, findings warrant additional exploration.",2019,"RESULTS
I-RED strategy did not yield statistically higher diagnostic accuracy compared to controls (62 vs. 48%, respectively; odd ratio = 2.07 [95% confidence interval, 0.78-5.5], P = 0.14) although participants reported higher decision confidence compared to controls (7.00 vs. 5.77 on a scale of 1 to 10, P ","['Two university-based residency programs', 'One-hundred and nine pediatric residents from all levels of training']",['cognitive intervention based on isolation of red flags (I-RED'],"['diagnostic accuracy', 'decision confidence', 'shortened time to decision', 'number of red flags']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}]",109.0,0.145605,"RESULTS
I-RED strategy did not yield statistically higher diagnostic accuracy compared to controls (62 vs. 48%, respectively; odd ratio = 2.07 [95% confidence interval, 0.78-5.5], P = 0.14) although participants reported higher decision confidence compared to controls (7.00 vs. 5.77 on a scale of 1 to 10, P ","[{'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Chartan', 'Affiliation': ""Department of Pediatrics, Section of Critical Care Medicine, Texas Children's Hospital/Baylor College of Medicine, 6651 Main St, Houston, TX, 77030, USA.""}, {'ForeName': 'Hardeep', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center and the Department of Medicine, Baylor College of Medicine, 2450 Holcombe Blvd Suite 01Y, Houston, TX, 77021 , USA.'}, {'ForeName': 'Parthasarathy', 'Initials': 'P', 'LastName': 'Krishnamurthy', 'Affiliation': 'Department of Marketing and Entrepreneurship, C.T. Bauer College of Business, University of Houston, 334 Melcher Hall, Houston, TX, 77204, USA.'}, {'ForeName': 'Moushumi', 'Initials': 'M', 'LastName': 'Sur', 'Affiliation': ""Department of Pediatrics, Section of Critical Care Medicine, Texas Children's Hospital/Baylor College of Medicine, 6651 Main St, Houston, TX, 77030, USA.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center and the Department of Medicine, Baylor College of Medicine, 2450 Holcombe Blvd Suite 01Y, Houston, TX, 77021 , USA.'}, {'ForeName': 'Riad', 'Initials': 'R', 'LastName': 'Lutfi', 'Affiliation': ""Riley Children's Hospital, Indiana University School of Medicine, 705 Riley Hospital Dr, Indianapolis, IN, 46202, USA.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Stark', 'Affiliation': ""Riley Children's Hospital, Indiana University School of Medicine, 705 Riley Hospital Dr, Indianapolis, IN, 46202, USA.""}, {'ForeName': 'Satid', 'Initials': 'S', 'LastName': 'Thammasitboon', 'Affiliation': ""Department of Pediatrics, Section of Critical Care Medicine, Texas Children's Hospital/Baylor College of Medicine, 6651 Main St, Houston, TX, 77030, USA.""}]",International journal for quality in health care : journal of the International Society for Quality in Health Care,['10.1093/intqhc/mzz082']
1606,31175807,"Low-Fat Dietary Pattern among Postmenopausal Women Influences Long-Term Cancer, Cardiovascular Disease, and Diabetes Outcomes.","BACKGROUND
The preferred macronutrient dietary composition, and the health consequences of dietary fat reduction specifically, have been debated for decades. Here we provide a comprehensive overview of long-term health outcomes in the Women's Health Initiative Dietary Modification (DM) trial.
OBJECTIVE
The DM trial aimed to examine whether a low-fat dietary pattern would reduce the risk of invasive breast cancer, colorectal cancer, and, secondarily, coronary heart disease (CHD), with various other health outcomes also considered.
METHODS
The DM trial is a randomized controlled trial conducted at 40 centers in the US, among 48,835 postmenopausal women aged 50-79 y with baseline intake of ≥32% energy from fat. Participants were randomly assigned to a low-fat dietary pattern intervention group or to a usual-diet comparison group, during 1993-1998. Intervention goals were to reduce fat intake from ∼35% to 20% of total energy, in conjunction with increasing vegetables and fruit to 5 servings/d and grains to 6 servings/d.
RESULTS
Over an 8.5-y (median) intervention period, intervention and comparison group differences included lower fat by 8-10%, and higher carbohydrate by 8-10%, of total energy, in conjunction with higher consumption of vegetables, fruit, and grains. Time-to-outcome analyses did not show significant differences between intervention and comparison groups for invasive breast cancer, colorectal cancer, or CHD, either over the intervention period or over longer-term cumulative follow-up. Additional analyses showed significant intervention group benefits related to breast cancer, CHD, and diabetes, without adverse effects. Over a 19.6-y (median) follow-up period, HRs (95% CIs) were 0.84 (0.74, 0.96) for breast cancer followed by death, and 0.87 (0.77, 0.98) for diabetes requiring insulin.
CONCLUSIONS
Reduction in dietary fat with corresponding increase in vegetables, fruit, and grains led to benefits related to breast cancer, CHD, and diabetes, without adverse effects, among healthy postmenopausal US women.
This trial was registered at clinicaltrials.gov as NCT00000611.",2019,"Time-to-outcome analyses did not show significant differences between intervention and comparison groups for invasive breast cancer, colorectal cancer, or CHD, either over the intervention period or over longer-term cumulative follow-up.","['40 centers in the US, among 48,835 postmenopausal women aged 50-79 y with baseline intake of ≥32% energy from fat', ""Women's Health Initiative Dietary Modification (DM) trial"", 'healthy postmenopausal US women']",['low-fat dietary pattern intervention group or to a usual-diet comparison'],"['breast cancer, CHD, and diabetes, without adverse effects', 'invasive breast cancer, colorectal cancer, or CHD', 'risk of invasive breast cancer, colorectal cancer, and, secondarily, coronary heart disease (CHD']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0086153', 'cui_str': 'Dietary Modification'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]",48835.0,0.112797,"Time-to-outcome analyses did not show significant differences between intervention and comparison groups for invasive breast cancer, colorectal cancer, or CHD, either over the intervention period or over longer-term cumulative follow-up.","[{'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Barbara V', 'Initials': 'BV', 'LastName': 'Howard', 'Affiliation': 'Department of Medicine, Georgetown University Medical Center, and MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'Oncology/Hematology, Division of Medicine, Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'College of Public Health, Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lesley F', 'Initials': 'LF', 'LastName': 'Tinker', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lewis E', 'Initials': 'LE', 'LastName': 'Kuller', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Sciences Center, Memphis, TN, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Snetselaar', 'Affiliation': 'Preventive Nutrition Education, Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Jacques E', 'Initials': 'JE', 'LastName': 'Rossouw', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz107']
1607,30358864,"Transcranial Direct Current Stimulation for Affective Symptoms and Functioning in Chronic Low Back Pain: A Pilot Double-Blinded, Randomized, Placebo-Controlled Trial.","BACKGROUND AND OBJECTIVE
Chronic low back pain (CLBP) is highly prevalent, with a substantial psychosocial burden. Pain has both sensory and affective components. The latter component is a significant driver of disability and psychiatric comorbidity but is often inadequately treated. Previously we reported that noninvasive transcranial direct current stimulation (tDCS) may modulate pain-associated affective distress. Here we tested whether 10 daily tDCS sessions aimed to inhibit the left dorsal anterior cingulate cortex (dACC), a region strongly implicated in the affective component of pain, would produce selective reduction in pain-related symptoms.
METHODS
In this multisite, double-blinded, randomized placebo-controlled trial (RCT), 21 CLBP patients received 10 weekday sessions of 2-mA active tDCS or sham (20 minutes/session). A cathodal electrode was placed over FC1 (10-20 electroencephalography coordinates), and an identical anodal return electrode was placed over the contralateral mastoid. Participants rated pain intensity, acceptance, interference, disability, and anxiety, plus general anxiety and depression.
RESULTS
Regression analysis noted significantly less pain interference (P =0.002), pain disability (P =0.001), and depression symptoms (P =0.003) at six-week follow-up for active tDCS vs sham. Omnibus tests suggested that these improvements were not merely due to baseline (day 1) group differences.
CONCLUSIONS
To our knowledge, this is the first double-blinded RCT of multiple tDCS sessions targeting the left dACC to modulate CLBP's affective symptoms. Results are encouraging, including several possible tDCS-associated improvements. Better-powered RCTs are needed to confirm these effects. Future studies should also consider different stimulation schedules, additional cortical targets, high-density multi-electrode tDCS arrays, and multimodal approaches.",2019,"Results
Regression analysis noted significantly less pain interference (P =0.002), pain disability (P =0.001), and depression symptoms (P =0.003) at six-week follow-up for active tDCS vs sham.","['Chronic Low Back Pain', '21 CLBP patients']","['noninvasive transcranial direct current stimulation (tDCS', 'Placebo', 'placebo', 'Transcranial Direct Current Stimulation']","['pain disability', 'pain interference', 'depression symptoms', 'disability and psychiatric comorbidity', 'pain intensity, acceptance, interference, disability, and anxiety, plus general anxiety and depression']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",21.0,0.744208,"Results
Regression analysis noted significantly less pain interference (P =0.002), pain disability (P =0.001), and depression symptoms (P =0.003) at six-week follow-up for active tDCS vs sham.","[{'ForeName': 'Timothy Y', 'Initials': 'TY', 'LastName': 'Mariano', 'Affiliation': 'Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Burgess', 'Affiliation': 'Center for Neurorestoration and Neurotechnology, Providence Veterans Affairs Medical Center, Providence, Rhode Island.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Bowker', 'Affiliation': 'Center for Neurorestoration and Neurotechnology, Providence Veterans Affairs Medical Center, Providence, Rhode Island.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kirschner', 'Affiliation': 'Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': ""Van't Wout-Frank"", 'Affiliation': 'Center for Neurorestoration and Neurotechnology, Providence Veterans Affairs Medical Center, Providence, Rhode Island.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Halladay', 'Affiliation': 'Center for Neurorestoration and Neurotechnology, Providence Veterans Affairs Medical Center, Providence, Rhode Island.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Greenberg', 'Affiliation': 'Butler Hospital, Providence, Rhode Island.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny188']
1608,31667735,Bioequivalence of a Newly Developed Dabigatran Etexilate Tablet Versus the Commercial Capsule and Impact of Rabeprazole-Induced Elevated Gastric pH on Exposure in Healthy Subjects.,"BACKGROUND AND OBJECTIVE
Dabigatran etexilate (DE) is an anticoagulant with proven efficacy and tolerability for stroke prevention in patients with non-valvular atrial fibrillation. For the commercial capsule, a complex formulation is used to maintain the acidic microenvironment required for maximal absorption. Consequently, its efficacy and safety are similar with or without concomitant intake of proton-pump inhibitors (PPIs). A simplified DE tablet formulation was developed and tested in two studies. One investigated bioequivalence (BE) of the novel DE tablet versus the commercial DE capsule. The other investigated DE bioavailability (BA) under pretreatment with the PPI rabeprazole and assessed the effect of elevated pH on exposure to dabigatran.
METHODS
BE of the novel DE tablet versus the DE capsule was assessed in a randomized two-treatment, four-period, two-sequence crossover study (NCT03070171). The effect of rabeprazole on the BA of the DE tablet was assessed in an open-label, single-arm study (NCT03143166). Both studies were conducted at sites in Japan. Participants were healthy male volunteers, aged ≥ 20-40 years. In the BE study, participants received the DE tablet or capsule (single oral dose, 110 mg); primary endpoints were area under the concentration-time curve from baseline to the last quantifiable data point (AUC 0-tz ) and maximum plasma concentration (C max ) of unconjugated dabigatran. In the relative BA study, participants received the DE tablet (single oral dose, 110 mg) with or without rabeprazole pretreatment (once daily for 5 days, 20 mg); primary endpoints were AUC 0-tz and C max of total dabigatran.
RESULTS
In total, 160 participants were randomized in the BE study; 36 participants were enrolled in the BA study. The 90% confidence intervals of geometric mean (gMean) ratios for AUC 0-tz (101.4-116.0%) and C max (101.8-116.6%) of unconjugated dabigatran were within pre-defined acceptance criteria for BE. In the relative BA study, the gMeans of AUC 0-tz (667 to 192 ng h/mL) and C max (83.1 to 21.8 ng/mL) were decreased by approximately 70% when the tablet was administered under rabeprazole pretreatment. The reduction in BA was observed at a mean gastric pH of 5.3. Treatment was well tolerated; no deaths, serious adverse events (AEs) or significant AEs were reported in either study.
CONCLUSION
The DE tablet demonstrated BE to the capsule; however, at high gastric pH, BA of the tablet was reduced by approximately 70%, which may lead to reduced efficacy. Data indicate the importance of examining not only BE under standard conditions, but relative BA at elevated gastric pH. Such investigations may avoid the reduced BA at elevated pH that is quite common in the target population (the elderly and/or patients treated with gastric-acid modifying co-medications), and therefore reduce treatment failure with DE. Registration: ClinicalTrials.gov identifier numbers: NCT03070171, and NCT03143166.",2020,"Treatment was well tolerated; no deaths, serious adverse events (AEs) or significant AEs were reported in either study.
","['patients with non-valvular atrial fibrillation', 'Healthy Subjects', '160 participants were randomized in the BE study; 36 participants were enrolled in the BA study', 'Registration', 'Participants were healthy male volunteers, aged\u2009≥\u200920-40\xa0years']","['rabeprazole', 'PPI rabeprazole', 'Dabigatran etexilate (DE', 'Rabeprazole-Induced Elevated Gastric pH']","['geometric mean (gMean) ratios for AUC 0-tz', 'reduction in BA', 'efficacy and safety', 'area under the concentration-time curve from baseline to the last quantifiable data point (AUC 0-tz ) and maximum plasma concentration (C max ) of unconjugated dabigatran', 'tolerated; no deaths, serious adverse events (AEs) or significant AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0522530', 'cui_str': 'Unconjugated (qualifier value)'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",160.0,0.202028,"Treatment was well tolerated; no deaths, serious adverse events (AEs) or significant AEs were reported in either study.
","[{'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Harada', 'Affiliation': 'Clinical PK/PD Department, Nippon Boehringer Ingelheim Co., Ltd., 6-7-5 Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan. akiko.harada@boehringer-ingelheim.com.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Ikushima', 'Affiliation': 'SOUSEIKAI Sumida Hospital, 1-29-1 Honjo, Sumida-ku, Tokyo, 130-0004, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Haranaka', 'Affiliation': 'SOUSEIKAI Hakata Clinic, 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025, Japan.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Yanagihara', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nakayama', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-019-00377-x']
1609,31572103,Retraction: Comparative study of mid-thoracic spinal versus epidural anesthesia for open nephrectomy in patients with obstructive/restrictive lung disease: A randomized controlled study.,"[This retracts the article on p. 52 in vol. 13, PMID: 30692889.].",2019,"[This retracts the article on p. 52 in vol. 13, PMID: 30692889.].",['patients with obstructive/restrictive lung disease'],['mid-thoracic spinal versus epidural anesthesia'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085581', 'cui_str': 'Restrictive lung disease (disorder)'}]","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]",[],,0.011878,"[This retracts the article on p. 52 in vol. 13, PMID: 30692889.].",[],Saudi journal of anaesthesia,['10.4103/1658-354X.188620']
1610,31657981,Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16.,"PURPOSE
Despite contemporary treatment, up to 10% of children with acute lymphoblastic leukemia still experience relapse. We evaluated whether a higher dosage of PEG-asparaginase and early intensification of triple intrathecal therapy would improve systemic and CNS control.
PATIENTS AND METHODS
Between 2007 and 2017, 598 consecutive patients age 0 to 18 years received risk-directed chemotherapy without prophylactic cranial irradiation in the St Jude Total Therapy Study 16. Patients were randomly assigned to receive PEG-asparaginase 3,500 U/m 2 versus the conventional 2,500 U/m 2 . Patients presenting features that were associated with increased risk of CNS relapse received two extra doses of intrathecal therapy during the first 2 weeks of remission induction.
RESULTS
The 5-year event-free survival and overall survival rates for the 598 patients were 88.2% (95% CI, 84.9% to 91.5%) and 94.1% (95% CI, 91.7% to 96.5%), respectively. Cumulative risk of any-isolated or combined-CNS relapse was 1.5% (95% CI, 0.5% to 2.5%). Higher doses of PEG-asparaginase did not affect treatment outcome. T-cell phenotype was the only independent risk factor for any CNS relapse (hazard ratio, 5.15; 95% CI, 1.3 to 20.6; P = . 021). Among 359 patients with features that were associated with increased risk for CNS relapse, the 5-year rate of any CNS relapse was significantly lower than that among 248 patients with the same features treated in the previous Total Therapy Study 15 (1.8% [95% CI, 0.4% to 3.3%] v 5.7% [95% CI, 2.8% to 8.6%]; P = .008). There were no significant differences in the cumulative risk of seizure or infection during induction between patients who did or did not receive the two extra doses of intrathecal treatment.
CONCLUSION
Higher doses of PEG-asparaginase failed to improve outcome, but additional intrathecal therapy during early induction seemed to contribute to improved CNS control without excessive toxicity for high-risk patients.",2019,"There were no significant differences in the cumulative risk of seizure or infection during induction between patients who did or did not receive the two extra doses of intrathecal treatment.
","['Between 2007 and 2017, 598 consecutive patients age 0 to 18 years received', '359 patients with features', 'children with acute lymphoblastic leukemia still experience relapse']","['PEG-asparaginase', 'risk-directed chemotherapy without prophylactic cranial irradiation', 'PEG-asparaginase 3,500 U/m 2 versus the conventional 2,500 U/m 2 ']","['cumulative risk of seizure or infection', 'risk for CNS relapse', 'risk of CNS relapse', '5-year event-free survival and overall survival rates', '5-year rate of any CNS relapse', 'Cumulative risk of any-isolated or combined-CNS relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",598.0,0.0488517,"There were no significant differences in the cumulative risk of seizure or infection during induction between patients who did or did not receive the two extra doses of intrathecal treatment.
","[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Deqing', 'Initials': 'D', 'LastName': 'Pei', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Sandlund', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Coustan-Smith', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Campana', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Inaba', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Ribeiro', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Susana C', 'Initials': 'SC', 'LastName': 'Raimondi', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Raja B', 'Initials': 'RB', 'LastName': 'Khan', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Mullighan', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Evans', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01692']
1611,25935875,Effect of genetic variations on ticagrelor plasma levels and clinical outcomes.,"AIMS
Ticagrelor, a direct-acting P2Y12-receptor antagonist, is rapidly absorbed and partly metabolized to the major metabolite AR-C124910XX (ARC). To identify single-nucleotide polymorphisms (SNPs) associated with pharmacokinetics of ticagrelor and clinical outcomes, we performed a genome-wide association study (GWAS) in patients treated with ticagrelor in the PLATO trial.
METHODS AND RESULTS
A two-stage design was used for the GWAS with discovery (discovery phase: n = 1812) and replication cohorts (replication phase: n = 1941). The steady-state area under the curve (AUCss) values, estimated by the population pharmacokinetic (PK) models, were log transformed and analysed on a genome-wide scale using linear regression. SNPs were analysed against clinical events using Cox-regression in 4990 patients. An SNP (rs113681054) in SLCO1B1 was associated with levels of ticagrelor (P = 1.1 × 10(-6)) and ARC (P = 4.6 × 10(-13)). This SNP is in linkage disequilibrium with a functional variant (rs4149056) that results in decreased OATP1B1 transporter activity. Ticagrelor levels were also associated with two independent SNPs (rs62471956, P = 7.7 × 10(-15) and rs56324128, P = 9.7 × 10(-12)) in the CYP3A4 region. Further, ARC levels were associated with rs61361928 (P = 3.0 × 10(-14)) in UGT2B7. At all loci, the effects were small. None of the identified SNPs that affected ticagrelor PK were associated with the primary composite outcome (cardiovascular death myocardial infarction, and stroke), non-CABG-related bleeds or investigator-reported dyspnoea.
CONCLUSION
In patients with ACS, ticagrelor pharmacokinetics is influenced by three genetic loci (SLCO1B1, UGT2B7, and CYP3A4). However, the modest genetic effects on ticagrelor plasma levels did not translate into any detectable effect on efficacy or safety during ticagrelor treatment.
CLINICAL TRIAL REGISTRATION
NCT00391872.",2015,An SNP (rs113681054) in SLCO1B1 was associated with levels of ticagrelor (P = 1.1 × 10(-6)) and ARC (P = 4.6 × 10(-13)).,"['patients treated with ticagrelor in the PLATO trial', '4990 patients', 'A two-stage design was used for the GWAS with discovery (discovery phase: n = 1812) and replication cohorts (replication phase: n = 1941']",['Ticagrelor'],"['ticagrelor plasma levels', 'Ticagrelor levels', 'efficacy or safety', 'ARC levels', 'steady-state area under the curve (AUCss) values, estimated by the population pharmacokinetic (PK) models', 'primary composite outcome (cardiovascular death myocardial infarction, and stroke), non-CABG-related bleeds or investigator-reported dyspnoea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0043566', 'cui_str': 'PLATO'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]",4990.0,0.0283957,An SNP (rs113681054) in SLCO1B1 was associated with levels of ticagrelor (P = 1.1 × 10(-6)) and ARC (P = 4.6 × 10(-13)).,"[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Varenhorst', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjölds väg 14B, level 1, SE-751 85 Uppsala, Sweden christoph.varenhorst@ucr.uu.se.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Eriksson', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjölds väg 14B, level 1, SE-751 85 Uppsala, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Johansson', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjölds väg 14B, level 1, SE-751 85 Uppsala, Sweden Department of Immunology, Genetics and Pathology, Science for Life Laboratory, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Barratt', 'Affiliation': 'AstraZeneca R&D, Alderley Park, Cheshire, UK.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Hagström', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjölds väg 14B, level 1, SE-751 85 Uppsala, Sweden.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Åkerblom', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjölds väg 14B, level 1, SE-751 85 Uppsala, Sweden.'}, {'ForeName': 'Ann-Christine', 'Initials': 'AC', 'LastName': 'Syvänen', 'Affiliation': 'Department of Medical Sciences, Molecular Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Disease, Heart, Lung and Vascular Institute, Academic Health Center, Cincinnati, OH, USA Heart, Lung and Vascular Institute, Cardiovascular Services, University of Cincinnati Health System, Cincinnati, OH, USA.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjölds väg 14B, level 1, SE-751 85 Uppsala, Sweden.'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Katus', 'Affiliation': 'Medizinische Klinik, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Husted', 'Affiliation': 'Medical Department, Hospital Unit West, Herning/Holstebro, Denmark.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'INSERM-Unité 1148, Paris, France Assistance Publique-Hôpitaux de Paris, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Paris, France Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France NHLI Imperial College, ICMS, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjölds väg 14B, level 1, SE-751 85 Uppsala, Sweden Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Voora', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Renli', 'Initials': 'R', 'LastName': 'Teng', 'Affiliation': 'AstraZeneca LP, Wilmington, DE, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Cardiovascular Science, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjölds väg 14B, level 1, SE-751 85 Uppsala, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehv116']
1612,30365464,Everolimus and Long-term Clinical Outcomes in Kidney Transplant Recipients: A Registry-based 10-year Follow-up of 5 Randomized Trials.,"BACKGROUND
Data regarding the long-term efficacy of everolimus-based immunosuppression for kidney transplantation are lacking. Existing randomized controlled trials are limited by short follow-up duration which limits capacity to assess impact on graft and patient survival.
METHODS
We linked individual trial participants to the Australian and New Zealand Dialysis and Transplant Registry. Using a 1-step meta-analysis approach, we investigated the 10-year risk of graft loss, mortality and graft function in 349 participants from 5 randomized trials of everolimus-based immunosuppression.
RESULTS
Two hundred forty-two patients randomized to everolimus and 107 control patients were followed for a median of 9 years (interquartile range, 7.1, 9.8 y). There were no significant differences in the risk of all-cause graft loss (adjusted hazard ratio [HR], 1.16; 95% confidence interval [CI], 0.69-1.94), mortality (adjusted HR, 1.51; 95% CI, 0.78-2.93) and death-censored graft loss in everolimus versus control (adjusted HR, 1.00; 95% CI, 0.50-2.01). For patients in the early initiation (de novo or <6-month conversion) everolimus trials (n = 279), decline in estimated glomerular filtration rate did not significantly differ with control (mean difference in the slope of estimated glomerular filtrate rate, 0.01 mL/min per 1.73 m [-0.06 to +0.09]).
CONCLUSIONS
This registry-based analysis with long-term follow-up found no differences in graft and recipient survival or graft function for everolimus over current standard of care.",2019,"This registry-based analysis with long-term follow-up found no differences in graft and recipient survival, or graft function for everolimus over current standard-of-care.","['349 participants from five randomised-trials of', 'Two-hundred and forty-two patients randomised to', 'Kidney Transplant Recipients', 'individual trial participants to the Australian and New Zealand Dialysis and Transplant Registry']","['everolimus-based immunosuppression', 'everolimus', 'Everolimus']","['graft and recipient survival, or graft function', 'glomerular filtration rate (eGFR', 'death-censored graft loss', 'risk of all-cause graft loss', 'mortality']","[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",349.0,0.427661,"This registry-based analysis with long-term follow-up found no differences in graft and recipient survival, or graft function for everolimus over current standard-of-care.","[{'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Ying', 'Affiliation': 'Renal Medicine, Royal Prince Alfred Hospital, Kidney Node at Charles Perkins Centre, Sydney Medical School, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': ""Centre for Transplant and Renal Research, Westmead Hospital, Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.""}, {'ForeName': 'Wai H', 'Initials': 'WH', 'LastName': 'Lim', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, School of Medicine, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clayton', 'Affiliation': 'Central and Northern Adelaide Renal and Transplantation Services, South Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kanellis', 'Affiliation': 'Department of Nephrology, Monash Health, Clayton, Centre for Inflammatory Diseases Department of Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pilmore', 'Affiliation': 'Department of Renal Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'Department of Renal Medicine, University of Queensland at Princess Alexandria Hospital, Woolloongabba, QLD, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Renal Medicine, Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Russ', 'Affiliation': 'Central and Northern Adelaide Renal and Transplantation Services, South Australia, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Chadban', 'Affiliation': 'Renal Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}]",Transplantation,['10.1097/TP.0000000000002499']
1613,31664444,Effect of Combination l-Citrulline and Metformin Treatment on Motor Function in Patients With Duchenne Muscular Dystrophy: A Randomized Clinical Trial.,"Importance
Nitric oxide precursors, such as the amino acid l-arginine and the biguanide antidiabetic drug metformin, have been associated with metabolism and muscle function in patients with Duchenne muscular dystrophy (DMD). The treatment of DMD remains an unmet medical need.
Objective
To evaluate the benefits and harms of a combination of l-citrulline and metformin treatment among patients with DMD.
Design, Setting, and Participants
A single-center randomized double-blind placebo-controlled parallel-group clinical trial was conducted between December 12, 2013, and March 30, 2016, at the University Children's Hospital Basel in Switzerland. A total of 47 ambulant male patients aged 6.5 to 10 years with genetically confirmed DMD were recruited locally and from the patient registries of Switzerland, Germany, Austria, and France. Data were analyzed from April 6, 2016, to September 5, 2019.
Interventions
Patients in the treatment group received 2500 mg of l-citrulline and 250 mg of metformin (combination therapy) 3 times a day for 26 weeks compared with patients in the control group, who received placebo.
Main Outcomes and Measures
The primary end point was the change in transfer and standing posture, as assessed by the first dimension of the Motor Function Measure, version 32, from baseline to week 26. Secondary end points included assessments of timed function, quantitative muscle force, biomarkers for muscle necrosis, and adverse events. The 2 prespecified subgroups comprised patients who were able to walk 350 m or more in 6 minutes (stable subgroup) and patients who were not able to walk 350 m in 6 minutes (unstable subgroup) at baseline.
Results
Among 49 ambulant male children with DMD who were screened for eligibility, 47 patients with a mean (SD) age of 8.2 (1.1) years were randomized to a treatment group receiving combination therapy (n = 23) or a control group receiving placebo (n = 24), and 45 patients completed the study. No significant differences between groups were found in the results of timed function and muscle force tests for overall, proximal and axial, and distal motor function. Among patients receiving combination therapy, the Motor Function Measure first dimension subscore decrease was 5.5% greater than that of patients receiving placebo (95% CI, -1.0% to 12.1%; P = .09). The administration of combination therapy had significantly favorable effects on the first dimension subscore decrease among the 29 patients in the stable subgroup (6.7%; 95% CI, 0.9%-12.6%; P = .03) but not among the 15 patients in the unstable subgroup (3.9%; 95% CI, -13.2% to 20.9%; P = .63). Overall, the treatment was well tolerated with only mild adverse effects.
Conclusions and Relevance
Treatment with combination therapy was not associated with an overall reduction in motor function decline among ambulant patients with DMD; however, a reduction in motor function decline was observed among the stable subgroup of patients treated with combination therapy. The statistically nonsignificant difference of distal motor function in favor of combination therapy and the reduced degeneration of muscle tissue appear to support the treatment concept, but the study may have lacked sufficient statistical power. Further research exploring this treatment option with a greater number of patients is warranted.
Trial Registration
ClinicalTrials.gov identifier: NCT01995032.",2019,"No significant differences between groups were found in the results of timed function and muscle force tests for overall, proximal and axial, and distal motor function.","['47 ambulant male patients aged 6.5 to 10 years with genetically confirmed DMD were recruited locally and from the patient registries of Switzerland, Germany, Austria, and France', 'patients with Duchenne muscular dystrophy (DMD', 'ambulant patients with DMD', '47 patients with a mean (SD) age of 8.2 (1.1) years', 'patients with DMD', 'n\u2009=\u200924), and 45 patients completed the study', 'Patients With Duchenne Muscular Dystrophy', ""controlled parallel-group clinical trial was conducted between December 12, 2013, and March 30, 2016, at the University Children's Hospital Basel in Switzerland"", '49 ambulant male children with DMD who were screened for eligibility', 'patients who were able to walk 350 m or more in 6 minutes (stable subgroup) and patients who were not able to walk 350 m in 6 minutes (unstable subgroup) at baseline']","['l-citrulline and metformin', 'combination therapy', 'control group receiving placebo', 'Combination l-Citrulline and Metformin Treatment', 'placebo', '2500 mg of l-citrulline and 250 mg of metformin (combination therapy']","['motor function decline', 'change in transfer and standing posture, as assessed by the first dimension of the Motor Function Measure', 'distal motor function', 'timed function, quantitative muscle force, biomarkers for muscle necrosis, and adverse events', 'tolerated with only mild adverse effects', 'Motor Function', 'Motor Function Measure first dimension subscore decrease', 'first dimension subscore decrease', 'timed function and muscle force tests for overall, proximal and axial, and distal motor function']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}]","[{'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0235957', 'cui_str': 'Muscle necrosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}]",47.0,0.146866,"No significant differences between groups were found in the results of timed function and muscle force tests for overall, proximal and axial, and distal motor function.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Hafner', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bonati', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Vanya', 'Initials': 'V', 'LastName': 'Gocheva', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Schroeder', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Bernert', 'Affiliation': 'Department of Pediatrics, Kaiser Franz Josef Hospital, Vienna, Austria.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Laugel', 'Affiliation': 'Department of Pediatric Neurology, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Steinlin', 'Affiliation': 'Division of Pediatric Neurology, University of Berne Hospital, Berne, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Capone', 'Affiliation': ""Division of Pediatric Neurology, Children's Hospital, Aarau, Switzerland.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Gloor', 'Affiliation': 'Division of Radiological Physics, Department of Radiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bieri', 'Affiliation': 'Division of Radiological Physics, Department of Radiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Hemkens', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Speich', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zumbrunn', 'Affiliation': 'Clinical Trial Unit, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Nuri', 'Initials': 'N', 'LastName': 'Gueven', 'Affiliation': 'Pharmacy, School of Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': ""Division of Pediatric Neurology, University Children's Hospital Basel, Basel, Switzerland.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.14171']
1614,31658070,"The Vojta approach changes thicknesses of abdominal muscles and gait in children with spastic cerebral palsy: A randomized controlled trial, pilot study.","BACKGROUND
Children with cerebral palsy (CP) have abnormal postures and gait patterns. Many physiotherapists use the Vojta approach as intervention for children with CP. However, its effects remain unclear.
OBJECTIVE
This study aimed to investigate the effect of the Vojta approach on abdominal muscles and gait in children with spastic CP.
METHODS
Thirteen children with spastic CP were randomly assigned to a general exercise and a Vojta approach group. The interventions were administered in 30 min sessions, 3 times a week for a total of 6 weeks. We used ultrasonography to measure the thicknesses of the abdominal muscles. The gait and foot pressure were measured by GAITRite.
RESULTS
The Vojta approach group showed significant difference in the thicknesses of the rectus abdominis, and external oblique abdominal muscles, which are involved in trunk stability (p< 0.05). There were significant differences in the step width, functional ambulation profile, swing time, stance time, and single support % of cycle as well as foot pressure distribution (p< 0.05).
CONCLUSION
The Vojta approach may be considered as an effective treatment method for improving trunk stability and gait functions of children with spastic CP.",2020,"There were significant differences in the step width, functional ambulation profile, swing time, stance time, and single support % of cycle as well as foot pressure distribution (p< 0.05).
","['Children with cerebral palsy (CP', 'children with CP', 'Thirteen children with spastic CP', 'children with spastic CP', 'children with spastic cerebral palsy']","['Vojta approach', 'general exercise and a Vojta approach group']","['thicknesses of the rectus abdominis, and external oblique abdominal muscles, which are involved in trunk stability', 'trunk stability and gait functions', 'gait and foot pressure', 'step width, functional ambulation profile, swing time, stance time, and single support % of cycle as well as foot pressure distribution']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0000739', 'cui_str': 'Abdominal Muscles'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]",13.0,0.0388829,"There were significant differences in the step width, functional ambulation profile, swing time, stance time, and single support % of cycle as well as foot pressure distribution (p< 0.05).
","[{'ForeName': 'Yun-Hee', 'Initials': 'YH', 'LastName': 'Sung', 'Affiliation': ''}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Ha', 'Affiliation': ''}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-191726']
1615,31842828,"Promoting activity, Independence and stability in early dementia (PrAISED): a, multisite, randomised controlled, feasibility trial.","BACKGROUND
We tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions.
METHODS
We conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the 'Join Dementia Research' register. Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary.
RESULTS
Between September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention.
CONCLUSION
We conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).",2019,"Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain.","['Between September 2016 and March 2017', 'people with early dementia (PrAISED', 'Eligibility criteria were aged 65\u2009years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent', '60 patient participants and 54 carer participants from two sites', 'early dementia (PrAISED', ""Participants were recruited from Memory Assessment Service clinics and the 'Join Dementia Research' register"", 'Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12\u2009months']","['individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers', 'complex therapy intervention', 'high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control']","['recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions', 'Falls and activity', 'Disability Assessment for Dementia (DAD', 'physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain', 'recruitment and retention, intervention delivery and data completeness']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0557963', 'cui_str': 'Praising (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439045', 'cui_str': 'Memory assessment finding'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0035168'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0557963', 'cui_str': 'Praising (procedure)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}]",,0.171255,"Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Goldberg', 'Affiliation': 'School of Health Sciences, University of Nottingham, Queens Medical Centre, Nottingham, NG7 2UH, UK. sarah.goldberg@nottingham.ac.uk.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'van der Wardt', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'NWORTH, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Burgon', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rupinder', 'Initials': 'R', 'LastName': 'Bajwa', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'NWORTH, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Pip L', 'Initials': 'PL', 'LastName': 'Logan', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rowan H', 'Initials': 'RH', 'LastName': 'Harwood', 'Affiliation': 'School of Health Sciences, University of Nottingham, Queens Medical Centre, Nottingham, NG7 2UH, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC geriatrics,['10.1186/s12877-019-1379-5']
1616,30430343,Moderated Mediation of Perceived Intoxication and Sexual Arousal on Determinants of Sexual Risk Behavior in Men Who Have Sex with Men.,"Behavioral interventions remain the preferred strategy for reducing HIV-related risk behavior among men who have sex with men (MSM), one of the populations most affected by HIV. To improve intervention efforts, research is needed to identify cognitive-motivational factors that may play a role in sexual risk behaviors among MSM. This study sought to replicate and extend previous work from a heterosexual population that identified a serial mediation effect of perceived intoxication and subjective sexual arousal in the relationship between alcohol consumption and determinants of sexual risk in a population of MSM. Exploratory moderated mediation analyses tested subjective sexual arousal as a moderator of the indirect effect of alcohol consumption on determinants of sexual risk via perceived intoxication. Participants (N = 117 MSM, ages 21-50) were randomly assigned to one of six experimental conditions based on two manipulations: beverage condition (alcohol, placebo, or control) and sexual arousal (low or high). Dependent measures were likelihood to engage in risky sex and condom negotiation skills. Results did not support the serial mediation effect but showed some support for the moderated mediation model in the prediction of behavioral skills. Implications for alcohol and arousal myopia theories of risky behavior and HIV prevention efforts are discussed.",2019,Results did not support the serial mediation effect but showed some support for the moderated mediation model in the prediction of behavioral skills.,"['men who have sex with men (MSM', 'Participants (N\u2009=\u2009117 MSM, ages 21-50', 'Who Have Sex with Men', 'Men']","['beverage condition (alcohol, placebo, or control) and sexual arousal (low or high']","['likelihood to engage in risky sex and condom negotiation skills', 'Moderated Mediation of Perceived Intoxication and Sexual Arousal on Determinants of Sexual Risk Behavior', 'sexual risk via perceived intoxication']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation, function (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation, function (observable entity)'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.022508,Results did not support the serial mediation effect but showed some support for the moderated mediation model in the prediction of behavioral skills.,"[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Buckheit', 'Affiliation': 'Department of Psychology, Syracuse University, 430 Huntington Hall, Syracuse, NY, 13244, USA. kabuckhe@syr.edu.'}, {'ForeName': 'Luke D', 'Initials': 'LD', 'LastName': 'Mitzel', 'Affiliation': 'Department of Psychology, Syracuse University, 430 Huntington Hall, Syracuse, NY, 13244, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Department of Psychology, Syracuse University, 430 Huntington Hall, Syracuse, NY, 13244, USA.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, 02215, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanable', 'Affiliation': 'Department of Psychology, Syracuse University, 430 Huntington Hall, Syracuse, NY, 13244, USA.'}]",AIDS and behavior,['10.1007/s10461-018-2343-7']
1617,30554783,"Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial.","BACKGROUND
Pegbelfermin (BMS-986036), a PEGylated human fibroblast growth factor 21 (FGF21) analogue, has previously been shown to improve markers of metabolism and liver fibrosis in obese patients with type 2 diabetes. In this phase 2a study, we aimed to evaluate the safety and efficacy of pegbelfermin in patients with non-alcoholic steatohepatitis.
METHODS
In this multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2a study, we recruited adults (aged 21-75 years) with a body-mass index of at least 25 kg/m 2 , biopsy-confirmed non-alcoholic steatohepatitis (fibrosis stage 1-3), and a hepatic fat fraction of at least 10% when assessed by magnetic resonance imaging-proton density fat fraction. These patients were enrolled at 17 medical centres in the USA. Eligible patients were stratified by type 2 diabetes status and they were randomly assigned (1:1:1) by a computer-based system to receive subcutaneous injections of placebo once a day, 10 mg pegbelfermin once a day, or 20 mg pegbelfermin once a week, all for 16 weeks. Participants, the study team administering treatment, and investigators analysing outcomes (who were independent of the study team and had no further involvement) were masked to treatment groups. The primary outcomes were safety and the absolute change in hepatic fat fraction after 16 weeks of treatment. All patients who were randomly assigned to groups and received the study drug or placebo were included in the primary analyses. This trial was registered with ClinicalTrials.gov, number NCT02413372.
FINDINGS
Between May 12, 2015, and Aug 4, 2016, 184 overweight or obese patients with non-alcoholic steatohepatitis were screened for study inclusion. Of these, 95 (52%) patients were excluded because they no longer met study criteria and 80 (43%) patients entered the placebo lead-in phase. After further exclusions, 75 (94%) patients were randomly assigned to groups, received at least one dose of treatment (25 patients to receive 10 mg pegbelfermin once a day; 24 patients to receive 20 mg pegbelfermin once a week, and 26 patients to receive placebo), and were included in the primary analysis. A prespecified interim analysis at week 8 showed a greater than expected change in the primary outcome and supported early closing of patient enrolment, since this analysis indicated that the full planned sample size was not needed. We observed a significant decrease in absolute hepatic fat fraction in the group receiving 10 mg pegbelfermin daily (-6·8% vs -1·3%; p=0·0004) and in the group receiving 20 mg pegbelfermin weekly (-5·2% vs -1·3%; p=0·008) compared with the placebo group. Most adverse events were mild; the most common events were diarrhoea in eight (16%) of 49 patients treated with pegbelfermin and two (8%) of 26 patients treated with placebo and nausea in seven (14%) patients treated with pegbelfermin and two (8%) patients treated with placebo. There were no deaths, discontinuations due to adverse events, or treatment-related serious adverse events.
INTERPRETATION
Treatment with subcutaneously administered pegbelfermin for 16 weeks was generally well tolerated and significantly reduced hepatic fat fraction in patients with non-alcoholic steatohepatitis. Further study of pegbelfermin is warranted in patients with non-alcoholic steatohepatitis. Additional studies that use liver biopsies would allow for the assessment of pegbelfermin's effects on liver histology. Moreover, further studies should allow assessments of the safety and effectiveness of pegbelfermin in a larger number of patients.
FUNDING
Bristol-Myers Squibb.",2019,"There were no deaths, discontinuations due to adverse events, or treatment-related serious adverse events.
","['Eligible patients were stratified by type 2 diabetes status', 'patients were enrolled at 17 medical centres in the USA', 'obese patients with type 2 diabetes', 'Between May 12, 2015, and Aug 4, 2016, 184 overweight or obese patients with non-alcoholic steatohepatitis', 'recruited adults (aged 21-75 years) with a body-mass index of at least 25 kg/m 2 , biopsy-confirmed non-alcoholic steatohepatitis (fibrosis stage 1-3), and a hepatic fat fraction of at least 10% when assessed by magnetic resonance imaging-proton density fat fraction', 'patients with non-alcoholic steatohepatitis', '95 (52%) patients were excluded because they no longer met study criteria and 80 (43']","['pegbelfermin', 'pegbelfermin once a day; 24 patients to receive 20 mg pegbelfermin', 'Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue', 'placebo']","['absolute hepatic fat fraction', 'safety and efficacy', 'safety and the absolute change in hepatic fat fraction', 'diarrhoea', 'hepatic fat fraction', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.646098,"There were no deaths, discontinuations due to adverse events, or treatment-related serious adverse events.
","[{'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Edgar D', 'Initials': 'ED', 'LastName': 'Charles', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA. Electronic address: edgar.charles@bms.com.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Saint Louis University, Saint Louis, MO, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'Division of Gastroenterology, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX, USA.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Halegoua-DeMarzio', 'Affiliation': 'Department of Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Kundu', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Noviello', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Christian', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)31785-9']
1618,31658037,"Osteopathic manipulation treatment versus therapeutic exercises in patients with chronic nonspecific low back pain: A randomized, controlled and double-blind study.","BACKGROUND
Osteopathic manipulation treatment is widely used in the clinical practice in the care of patients with chronic nonspecific low back pain, however, its benefits still seem uncertain.
OBJECTIVE
This study aimed to verify the efficacy of osteopathic manipulation for chronic nonspecific low back pain.
MATERIALS AND METHODS
Forty-two participants with chronic nonspecific low back pain were selected and randomized into two groups: active control group (ACG - n= 19) and osteopathic manipulation treatment group (OMTG - n= 23). Therapeutic exercises were performed with the ACG and osteopathic manipulation techniques with the OMTG. The interventions were carried out over 5 weeks of treatment, totaling 10 treatments for the ACG and 5 for the OMTG.The visual analogue scale (VAS) was used to measure chronic nonspecific low back pain and the Oswestry Disability Index 2.0, Tampa Scale of Kinesiophobia and Beck Depression Inventory were used to measure disability, kinesiophobia and depression, respectively.
RESULTS
The final chronic nonspecific low back pain in both groups was significantly lower than the initial low back pain (p⩽ 0.01) and the final chronic nonspecific low back pain of the OMTG was significantly lower than that of the ACG (p= 0.001).
CONCLUSION
This study demonstrated that the treatments were effective in both groups. However, the efficacy of the osteopathic manipulation treatment was greater than that of the therapeutic exercises.",2020,"The final chronic nonspecific low back pain in both groups was significantly lower than the initial low back pain (p⩽ 0.01) and the final chronic nonspecific low back pain of the OMTG was significantly lower than that of the ACG (p= 0.001).
","['chronic nonspecific low back pain', 'patients with chronic nonspecific low back pain', 'Forty-two participants with chronic nonspecific low back pain']","['osteopathic manipulation', 'Active Control Group (ACG - n= 19) and Osteopathic Manipulation Treatment Group (OMTG - n= 23', 'ACG and 5 for the OMTG.The visual analogue scale (VAS', 'Osteopathic manipulation treatment versus therapeutic exercises']","['final chronic nonspecific low back pain of the OMTG', 'final chronic nonspecific low back pain', 'chronic nonspecific low back pain and the Oswestry Disability Index 2.0, Tampa Scale of Kinesiophobia and Beck Depression Inventory']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C0949744', 'cui_str': 'Osteopathic Manipulative Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0050397', 'cui_str': 'insulin potentiating fragments of growth hormone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",42.0,0.0281486,"The final chronic nonspecific low back pain in both groups was significantly lower than the initial low back pain (p⩽ 0.01) and the final chronic nonspecific low back pain of the OMTG was significantly lower than that of the ACG (p= 0.001).
","[{'ForeName': 'Frederico', 'Initials': 'F', 'LastName': 'de Oliveira Meirelles', 'Affiliation': 'Estacio de Sá University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Júlio César', 'Initials': 'JC', 'LastName': 'de Oliveira Muniz Cunha', 'Affiliation': 'Estacio de Sá University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Elirez Bezerra', 'Initials': 'EB', 'LastName': 'da Silva', 'Affiliation': 'Instituto de Educação Física e Desportos, Rio de Janeiro State University, Brazil, Rio de Janeiro.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181355']
1619,30466891,"Serum Free Methylated Glutathione S-transferase 1 DNA Levels, Survival, and Response to Docetaxel in Metastatic, Castration-resistant Prostate Cancer: Post Hoc Analyses of Data from a Phase 3 Trial.","BACKGROUND
Glutathione S-transferase 1 (GSTP1) expression is inactivated in >90% of all prostate cancers in association with aberrant DNA methylation. Detection of serum free methylated GSTP1 (mGSTP1) DNA is associated with overall survival (OS) and response to docetaxel in metastatic castration-resistant prostate cancer (mCRPC) in test and internal validation cohorts.
OBJECTIVE
To assess the relationship between serum free mGSTP1 and treatment outcomes in SYNERGY, a phase 3 multicentre randomised trial testing the addition of custirsen to first-line chemotherapy with docetaxel in mCRPC.
DESIGN, SETTING, AND PARTICIPANTS
Serum free mGSTP1 DNA was measured by a sensitive methylation-specific polymerase chain reaction assay in paired samples (baseline and after two cycles of docetaxel) from 600 patients.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Associations between serum free mGSTP1 at baseline, change in mGSTP1 after docetaxel, OS, and time to prostate-specific antigen (PSA) progression were examined using Cox proportional hazards models and Kaplan-Meier methods.
RESULTS AND LIMITATIONS
Serum free mGSTP1 was detectable at baseline in 458 (81%) patients. Of those with detectable mGSTP1 at baseline, mGSTP1 became undetectable after two cycles in 243 (53%). Undetectable mGSTP1 at baseline was associated with longer OS (hazard ratio [HR] 0.4, 95% confidence interval [CI] 0.29-0.55; p<0.00001). The event of mGSTP1 becoming undetectable after two cycles of chemotherapy was associated with longer OS (HR 0.36, 95% CI 0.29-0.46; p<0.00001) and longer time to PSA progression (HR 0.44, 95% CI 0.35-0.56; p<0.00001). Associations between mGSTP1 and clinical outcomes were independent of other established prognostic variables. Analysis was limited by the lack of radiographic progression-free survival data.
CONCLUSIONS
This is the first study to externally validate the prognostic role of a circulating epigenetic biomarker in mCRPC. Further studies are needed to validate serum free mGSTP1 as a surrogate endpoint for clinical trials and as a potential clinical decision tool.
PATIENT SUMMARY
In this study, we confirmed that a blood marker predicted outcomes after chemotherapy for metastatic prostate cancer. This marker may accelerate future clinical trials of new therapies and be useful in the clinic to guide treatment decisions.",2019,"Detection of serum free methylated GSTP1 (mGSTP1) DNA is associated with overall survival (OS) and response to docetaxel in metastatic castration-resistant prostate cancer (mCRPC) in test and internal validation cohorts.
","['600 patients', 'metastatic prostate cancer']","['custirsen to first-line chemotherapy with docetaxel', 'docetaxel']","['longer time to PSA progression', 'Serum Free Methylated Glutathione S-transferase 1 DNA Levels, Survival, and Response to Docetaxel in Metastatic, Castration-resistant Prostate Cancer', 'Serum free mGSTP1', 'radiographic progression-free survival data', 'mGSTP1 after docetaxel, OS, and time to prostate-specific antigen (PSA) progression']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}]","[{'cui': 'C4079860'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017837', 'cui_str': 'Glutathione Organic Nitrate Ester Reductase'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}]",600.0,0.274201,"Detection of serum free methylated GSTP1 (mGSTP1) DNA is associated with overall survival (OS) and response to docetaxel in metastatic castration-resistant prostate cancer (mCRPC) in test and internal validation cohorts.
","[{'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Mahon', 'Affiliation': ""Chris O'Brien Lifehouse, Sydney, Australia; Garvan Institute of Medical Research, Sydney, Australia; University of NSW, Sydney, Australia; University of Sydney, Sydney, Australia.""}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Qu', 'Affiliation': 'Garvan Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Hui-Ming', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'Garvan Institute of Medical Research, Sydney, Australia; University of NSW, Sydney, Australia.'}, {'ForeName': 'Calan', 'Initials': 'C', 'LastName': 'Spielman', 'Affiliation': 'Garvan Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cain', 'Affiliation': 'Oncogenex Pharmaceuticals Inc., Bothell, WA, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'Oncogenex Pharmaceuticals Inc., Bothell, WA, USA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': ""Chris O'Brien Lifehouse, Sydney, Australia; University of Sydney, Sydney, Australia; National Health and Medical Research Council Clinical Trials Centre, Sydney, Australia.""}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'University of Washington, Fred Hutchinson Cancer Research Centre, Seattle, WA, USA.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'Royal Marsden Hospital and Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'University of British Columbia, BC Cancer Agency, Vancouver Prostate Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Clark', 'Affiliation': 'Garvan Institute of Medical Research, Sydney, Australia; University of NSW, Sydney, Australia.'}, {'ForeName': 'Lisa Glen', 'Initials': 'LG', 'LastName': 'Horvath', 'Affiliation': ""Chris O'Brien Lifehouse, Sydney, Australia; Garvan Institute of Medical Research, Sydney, Australia; University of NSW, Sydney, Australia; University of Sydney, Sydney, Australia. Electronic address: lisa.horvath@lh.org.au.""}]",European urology,['10.1016/j.eururo.2018.11.001']
1620,30445177,Therapeutic efficacy of intense pulsed light in patients with refractory meibomian gland dysfunction.,"PURPOSE
To evaluate the efficacy and safety of intense pulsed light (IPL) combined with meibomian gland expression (MGX) for treatment of refractory meibomian gland dysfunction (MGD).
METHODS
Ninety eyes of 45 patients were randomly assigned to receive either the combination of IPL and MGX or MGX alone (control). Each eye underwent eight treatment sessions at 3-week intervals. Parameters were evaluated before and during treatment as well as at 3-11 weeks after the last treatment session. Measured parameters included the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score, noninvasive breakup time (NIBUT), fluorescein breakup time (BUT), lipid layer grade, lipid layer thickness (LLT), lid margin abnormalities, corneal and conjunctival fluorescein staining (CFS) score, meibum grade, and meiboscore.
RESULTS
A significant improvement in lipid layer grade was apparent in the IPL-MGX group from 6 to 32 weeks after treatment onset (adjusted P < 0.001) but was not observed in the control group. The IPL-MGX group also showed significant improvements in LLT, NIBUT, BUT, lid margin abnormalities, and meibum grade compared with the control group at 24 and 32 weeks (adjusted P < 0.001) as well as significant improvements in the SPEED score at 32 weeks (adjusted P = 0.044) and in CFS score at 24 (adjusted P = 0.015) and 32 (adjusted P = 0.006) weeks.
CONCLUSIONS
The combination of IPL and MGX improved homeostasis of the tear film and ameliorated ocular symptoms in patients with refractory MGD and is thus a promising modality for treatment of this condition.",2019,"The IPL-MGX group also showed significant improvements in LLT, NIBUT,","['patients with refractory meibomian gland dysfunction', 'Ninety eyes of 45 patients', 'patients with refractory MGD']","['IPL and MGX or MGX alone (control', 'IPL and MGX', 'IPL-MGX', 'intense pulsed light (IPL) combined with meibomian gland expression (MGX', 'intense pulsed light']","['homeostasis of the tear film and ameliorated ocular symptoms', 'Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score, noninvasive breakup time (NIBUT), fluorescein breakup time (BUT), lipid layer grade, lipid layer thickness (LLT), lid margin abnormalities, corneal and conjunctival fluorescein staining (CFS) score, meibum grade, and meiboscore', 'SPEED score', 'BUT, lid margin abnormalities, and meibum grade', 'LLT, NIBUT', 'CFS score', 'efficacy and safety', 'lipid layer grade', 'Therapeutic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025181', 'cui_str': 'Tarsal Glands'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]","[{'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C1318787', 'cui_str': 'Fluorescein stain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",45.0,0.0333797,"The IPL-MGX group also showed significant improvements in LLT, NIBUT,","[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Arita', 'Affiliation': 'Itoh Clinic, Saitama, Japan; Lid and Meibomian Gland Working Group (LIME), Japan. Electronic address: ritoh@za2.so-net.ne.jp.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Fukuoka', 'Affiliation': 'Omiya Hamada Eye Clinic, Saitama, Japan; Lid and Meibomian Gland Working Group (LIME), Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Morishige', 'Affiliation': 'Division of Cornea and Ocular Surface, Oshima Eye Hospital, Fukuoka, Japan; Lid and Meibomian Gland Working Group (LIME), Japan.'}]",The ocular surface,['10.1016/j.jtos.2018.11.004']
1621,30353773,Evaluating the effectiveness of cognitive rehabilitation on everyday memory in multiple sclerosis patients.,"The aim was to determine the effectiveness of cognitive rehabilitation for everyday memory function in patients with multiple sclerosis. A total of 60 multiple sclerosis patients with cognitive impairment were randomly assigned to three groups, experimental, placebo and control. The groups were well matched in baseline characteristics. Everyday memory was assessed at baseline immediately post-intervention (8 weeks) and five weeks post-intervention. The experimental group received cognitive rehabilitation programme in 1-hour sessions on a weekly basis for 8 weeks. The placebo group received relaxation techniques on a weekly basis for eight weeks and the control group received no intervention. The results indicated that a cognitive rehabilitation programme had a positive effect on the everyday memory of patients in the experimental group post-intervention. However, there was no significant effect of intervention 5 weeks post-intervention. The present study demonstrated that cognitive rehabilitation had a positive effect on the everyday function of the multiple sclerosis patients. However, the effect did not last and that everyday memory function returned to its pre-intervention level.",2020,The results indicated that a cognitive rehabilitation programme had a positive effect on the everyday memory of patients in the experimental group post-intervention.,"['60 multiple sclerosis patients with cognitive impairment', 'patients with multiple sclerosis', 'multiple sclerosis patients']","['placebo', 'relaxation techniques', 'control group received no intervention', 'cognitive rehabilitation programme', 'cognitive rehabilitation', 'placebo and control']","['everyday memory function', 'Everyday memory', 'everyday memory']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035029', 'cui_str': 'Relaxation Technics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}]",60.0,0.0585572,The results indicated that a cognitive rehabilitation programme had a positive effect on the everyday memory of patients in the experimental group post-intervention.,"[{'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Zare', 'Affiliation': 'Department of Psychology, Payame Noor University, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Etemadifar', 'Affiliation': 'Department of Neurology Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2018.1536608']
1622,31664441,Effect of Weight Loss via Severe vs Moderate Energy Restriction on Lean Mass and Body Composition Among Postmenopausal Women With Obesity: The TEMPO Diet Randomized Clinical Trial.,"Importance
Severely energy-restricted diets are the most effective dietary obesity treatment. However, there are concerns regarding potential adverse effects on body composition.
Objective
To compare the long-term effects of weight loss via severe vs moderate energy restriction on lean mass and other aspects of body composition.
Design, Setting, and Participants
The Type of Energy Manipulation for Promoting Optimum Metabolic Health and Body Composition in Obesity (TEMPO) Diet Trial was a 12-month, single-center, randomized clinical trial. A total of 101 postmenopausal women, aged 45 to 65 years with body mass index (calculated as weight in kilograms divided by height in meters squared) from 30 to 40, who were at least 5 years after menopause, had fewer than 3 hours of structured physical activity per week, and lived in the Sydney metropolitan area of New South Wales, Australia, were recruited between March 2013 and July 2016. Data analysis was conducted between October 2018 and August 2019.
Intervention
Participants were randomized to either 12 months of moderate (25%-35%) energy restriction with a food-based diet (moderate intervention) or 4 months of severe (65%-75%) energy restriction with a total meal replacement diet followed by moderate energy restriction for an additional 8 months (severe intervention). Both interventions had a prescribed protein intake of 1.0 g/kg of actual body weight per day, and physical activity was encouraged but not supervised.
Main Outcomes and Measures
The primary outcome was whole-body lean mass at 12 months after commencement of intervention. Secondary outcomes were body weight, thigh muscle area and muscle function (strength), bone mineral density, and fat mass and distribution, measured at 0, 4, 6, and 12 months.
Results
A total of 101 postmenopausal women were recruited (mean [SD] age, 58.0 [4.2] years; mean [SD] weight, 90.8 [9.1] kg; mean [SD] body mass index, 34.4 [2.5]). Compared with the moderate group at 12 months, the severe group lost more weight (effect size, -6.6 kg; 95% CI, -8.2 to -5.1 kg), lost more whole-body lean mass (effect size, -1.2 kg; 95% CI, -2.0 to -0.4 kg), and lost more thigh muscle area (effect size, -4.2 cm2; 95% CI, -6.5 to -1.9 cm2). However, decreases in whole-body lean mass and thigh muscle area were proportional to total weight loss, and there was no difference in muscle (handgrip) strength between groups. Total hip bone mineral density (effect size, -0.017 g/cm2; 95% CI, -0.029 to -0.005 g/cm2), whole-body fat mass (effect size, -5.5 kg; 95% CI, -7.1 to -3.9 kg), abdominal subcutaneous adipose tissue (effect size, -1890 cm3; 95% CI, -2560 to -1219 cm3), and visceral adipose tissue (effect size, -1389 cm3; 95% CI, -1748 to -1030 cm3) loss were also greater for the severe group than for the moderate group at 12 months.
Conclusions and Relevance
Severe energy restriction had no greater adverse effect on relative whole-body lean mass or handgrip strength compared with moderate energy restriction and was associated with 2-fold greater weight and fat loss over 12 months. However, there was significantly greater loss of total hip bone mineral density with severe vs moderate energy restriction. Therefore, caution is necessary when implementing severe energy restriction in postmenopausal women, particularly those with osteopenia or osteoporosis.
Trial Registration
anzctr.org.au Identifier: 12612000651886.",2019,"Total hip bone mineral density (effect size, -0.017 g/cm2; 95% CI, -0.029 to -0.005 g/cm2), whole-body fat mass (effect size, -5.5 kg; 95% CI, -7.1 to -3.9 kg), abdominal subcutaneous adipose tissue (effect size, -1890 cm3; 95% CI, -2560 to -1219 cm3), and visceral adipose tissue (effect size, -1389 cm3; 95% CI, -1748 to -1030 cm3) loss were also greater for the severe group than for the moderate group at 12 months.
","['Postmenopausal Women With Obesity', 'postmenopausal women, particularly those with osteopenia or osteoporosis', '101 postmenopausal women were recruited (mean [SD] age, 58.0 [4.2] years', '101 postmenopausal women, aged 45 to 65 years with body mass index (calculated as weight in kilograms divided by height in meters squared) from 30 to 40, who were at least 5 years after menopause, had fewer than 3 hours of structured physical activity per week, and lived in the Sydney metropolitan area of New South Wales, Australia, were recruited between March 2013 and July 2016']","['Weight Loss via Severe vs Moderate Energy Restriction', 'moderate (25%-35%) energy restriction with a food-based diet (moderate intervention) or 4 months of severe (65%-75%) energy restriction with a total meal replacement diet followed by moderate energy restriction for an additional 8 months (severe intervention', 'weight loss via severe vs moderate energy restriction']","['Total hip bone mineral density', 'thigh muscle area', 'weight and fat loss', 'whole-body lean mass', 'visceral adipose tissue', 'total weight loss', 'Optimum Metabolic Health and Body Composition in Obesity (TEMPO', 'muscle (handgrip) strength', 'total hip bone mineral density', 'weight', 'abdominal subcutaneous adipose tissue', 'Lean Mass and Body Composition', 'body weight, thigh muscle area and muscle function (strength), bone mineral density, and fat mass and distribution, measured at 0, 4, 6, and 12 months']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0587113', 'cui_str': 'After menopause (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0559897', 'cui_str': 'Diet followed (observable entity)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1563741', 'cui_str': 'Subcutaneous Fat, Abdominal'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",101.0,0.155129,"Total hip bone mineral density (effect size, -0.017 g/cm2; 95% CI, -0.029 to -0.005 g/cm2), whole-body fat mass (effect size, -5.5 kg; 95% CI, -7.1 to -3.9 kg), abdominal subcutaneous adipose tissue (effect size, -1890 cm3; 95% CI, -2560 to -1219 cm3), and visceral adipose tissue (effect size, -1389 cm3; 95% CI, -1748 to -1030 cm3) loss were also greater for the severe group than for the moderate group at 12 months.
","[{'ForeName': 'Radhika V', 'Initials': 'RV', 'LastName': 'Seimon', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Wild-Taylor', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'School of Human Movement and Nutrition Sciences, Centre for Research on Exercise, Physical Activity and Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClintock', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Harper', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Alice A', 'Initials': 'AA', 'LastName': 'Gibson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Hamish A', 'Initials': 'HA', 'LastName': 'Fernando', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Tania P', 'Initials': 'TP', 'LastName': 'Markovic', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Center', 'Affiliation': ""Bone Biology Program, Garvan Institute of Medical Research, St Vincent's Hospital Clinical School, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Metabolism and Obesity Services, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Harbor-University of California Los Angeles Medical Center and Los Angeles BioMedical Research Institute, Los Angeles.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Grieve', 'Affiliation': 'Sydney Translational Imaging Laboratory, Heart Research Institute, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Lagopoulos', 'Affiliation': 'Sunshine Coast Mind and Neuroscience-Thompson Institute, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Caterson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nuala M', 'Initials': 'NM', 'LastName': 'Byrne', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sainsbury', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.13733']
1623,31545663,Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia.,"PURPOSE
Chemotherapy-induced thrombocytopenia (CIT) leads to delay or reduction in cancer treatment. There is no approved treatment.
METHODS
We conducted a phase II randomized trial of romiplostim versus untreated observation in patients with solid tumors with CIT. Before enrollment, patients had platelets less than 100,000/μL for at least 4 weeks, despite delay or dose reduction of chemotherapy. Patients received weekly titrated romiplostim with a target platelet count of 100,000/μL or more, or were monitored with usual care. The primary end point was correction of platelet count within 3 weeks. Twenty-three patients were treated in a randomization phase, and an additional 37 patients were treated in a single-arm, romiplostim phase. Resumption of chemotherapy without recurrent CIT was a secondary end point.
RESULTS
The mean platelet count at enrollment was 62,000/μL. In the randomization phase, 14 of 15 romiplostim-treated patients (93%) experienced correction of their platelet count within 3 weeks, compared with one of eight control patients (12.5%; P < .001). Including all romiplostim-treated patients (N = 52), the mean platelet count at 2 weeks of treatment was 141,000/μL. The mean platelet count in the eight observation patients at 3 weeks was 57,000/μL. Forty-four patients who achieved platelet correction with romiplostim resumed chemotherapy with weekly romiplostim. Only three patients (6.8%) experienced recurrent reduction or delay of chemotherapy because of isolated CIT.
CONCLUSION
This prospective trial evaluated treatment of CIT with romiplostim. Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.",2019,"Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.",['patients with solid tumors with CIT'],"['romiplostim', 'titrated romiplostim with a target platelet count of 100,000/μL or more, or were monitored with usual care']","['recurrent reduction or delay of chemotherapy', 'despite delay or dose reduction of chemotherapy', 'mean platelet count', 'correction of platelet count', 'correction of their platelet count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0607063', 'cui_str': 'serum P-component'}]","[{'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1299577', 'cui_str': 'Delay of chemotherapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}]",44.0,0.0328062,"Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.","[{'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Soff', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Yimei', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Bendheim', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Batista', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jodi V', 'Initials': 'JV', 'LastName': 'Mones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Parameswaran', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Cy R', 'Initials': 'CR', 'LastName': 'Wilkins', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Devlin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cercek', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Kemeny', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Debra M', 'Initials': 'DM', 'LastName': 'Sarasohn', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mantha', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01931']
1624,30480133,Exploring Older Adults' Video Game Use in the PRISM Computer System.,"Background and Objective
As part of the PRISM (Personal Reminder Information & Social Management) randomized field trial, a large group of older adults ( N = 150) received a computer system in their home that presented them with the opportunity to play eleven different video games. While researchers have often assessed older adults' gaming preferences and habits through survey data and focus groups, this trial represented a unique opportunity to study gaming behavior ""in the wild"" over an entire year.
Research Design and Methods
We present an exploration of game usage data, individual differences in game preferences and gaming habits, and individual difference predictors of game use.
Results
Although few individual difference variables consistently predicted game use and preferences, there were clear favorites among the different games, and results demonstrate that given the opportunity and training many older adults may become active and long-term gamers.
Discussion and Implications
Findings have implications for designing video games that older adults enjoy, supporting enjoyable and meaningful interactions with video games across the life span, and for designing cognitive, social, and health interventions involving games.",2018,"Although few individual difference variables consistently predicted game use and preferences, there were clear favorites among the different games, and results demonstrate that given the opportunity and training many older adults may become active and long-term gamers.
",['older adults ( N = 150'],['computer system in their home that presented them with the opportunity to play eleven different video games'],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0009612', 'cui_str': 'Computer Systems'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]",[],,0.0282499,"Although few individual difference variables consistently predicted game use and preferences, there were clear favorites among the different games, and results demonstrate that given the opportunity and training many older adults may become active and long-term gamers.
","[{'ForeName': 'Walter R', 'Initials': 'WR', 'LastName': 'Boot', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee.'}, {'ForeName': 'Jerad H', 'Initials': 'JH', 'LastName': 'Moxley', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences.'}, {'ForeName': 'Nelson A', 'Initials': 'NA', 'LastName': 'Roque', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Andringa', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Charness', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Czaja', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sharit', 'Affiliation': 'Department of Industrial Engineering, University of Miami, Florida.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Mitzner', 'Affiliation': 'School of Psychology, Georgia Institute of Technology, Atlanta.'}, {'ForeName': 'Chin Chin', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Rogers', 'Affiliation': 'Kinesiology & Community Health, University of Illinois at Urbana-Champaign.'}]",Innovation in aging,['10.1093/geroni/igy009']
1625,30343411,"Effectiveness and safety of a product containing diosmin, coumarin, and arbutin (Linfadren®) in addition to complex decongestive therapy on management of breast cancer-related lymphedema.","PURPOSE
To assess the effectiveness and safety of a product containing diosmin, coumarin, and arbutin (Linfadren®) in addition to complex decongestive therapy (CDT) on the management of patients with a breast cancer-related lymphedema (BCRL).
METHODS
Fifty outpatients (average age of 56.2 ± 2.7 years, range 28-71) with a BCRL were enrolled for this study. Patients were randomly assigned (1:1 ratio) to receive either CDT consisting of skin care, manual lymphatic drainage, remedial exercises, and elastic compression garment (control group, n = 25) or CDT plus Linfadren® (study group, n = 25). Patients were evaluated before and after treatment and 3 months after the end of treatment. Primary outcomes were reduction of upper limb excess volume (EV) and percentage reduction of excess volume (%REV). Secondary outcomes were improvement in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, and patient's perception of treatment effectiveness (PPTE).
RESULTS
Addition of Linfadren® to CDT yielded an additional reduction of primary outcomes both after treatment (EV, - 521 ml vs. - 256 ml, P < 0.0001; %REV, - 66.4% vs. - 34%, P = 0.02) and at 3-month follow-up (EV, - 59 ml vs. + 24 ml, P < 0.0001; %REV, - 73.6% vs. - 31.4%, P = 0.004). Moreover, statistically significant differences were found between the two groups for the secondary outcomes after treatment (QuickDASH, P = 0.006; PPTE, P = 0.03) and at 3-month follow-up (QuickDASH, P = 0.006; PPTE, P = 0.02). No patient showed adverse events.
CONCLUSIONS
Linfadren® in addition to CDT was a safe and effective therapy for reducing BCRL and was better than CDT alone.",2019,"Moreover, statistically significant differences were found between the two groups for the secondary outcomes after treatment (QuickDASH, P = 0.006; PPTE, P = 0.03) and at 3-month follow-up (QuickDASH, P = 0.006; PPTE, P = 0.02).","['2.7\xa0years, range 28-71) with a BCRL were enrolled for this study', 'Fifty outpatients (average age of 56.2\u2009±', 'breast cancer-related lymphedema', 'patients with a breast cancer-related lymphedema (BCRL']","['complex decongestive therapy (CDT', 'CDT consisting of skin care, manual lymphatic drainage, remedial exercises, and elastic compression garment (control group, n\u2009=\u200925) or CDT plus Linfadren®', 'product containing diosmin, coumarin, and arbutin (Linfadren®', 'complex decongestive therapy']","['adverse events', 'reduction of upper limb excess volume (EV) and percentage reduction of excess volume (%REV', 'Effectiveness and safety', 'effectiveness and safety', ""Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, and patient's perception of treatment effectiveness (PPTE""]","[{'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}, {'cui': 'C0556834', 'cui_str': 'Manual Lymphatic Drainage'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012498', 'cui_str': 'Diosmin'}, {'cui': 'C0010206', 'cui_str': 'coumarin'}, {'cui': 'C0003729', 'cui_str': 'Arbutin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",50.0,0.0585967,"Moreover, statistically significant differences were found between the two groups for the secondary outcomes after treatment (QuickDASH, P = 0.006; PPTE, P = 0.03) and at 3-month follow-up (QuickDASH, P = 0.006; PPTE, P = 0.02).","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Cacchio', 'Affiliation': ""Department of Life, Health & Environmental Sciences, School of Medicine, University of L'Aquila, L'Aquila, Italy. angelo.cacchio@univaq.it.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Prencipe', 'Affiliation': ""Rehabilitation Service ex Polio Centre, ASL 01 Avezzano-Sulmona, L'Aquila, Avezzano, Italy.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bertone', 'Affiliation': 'Rehabilitation Service, ""Serafino Rinaldi"" Territorial Assistance Hospital of Pescina, ASL 01 Avezzano-Sulmona, L\'Aquila, Pescina, Italy.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'De Benedictis', 'Affiliation': 'Rehabilitation Service, ""Serafino Rinaldi"" Territorial Assistance Hospital of Pescina, ASL 01 Avezzano-Sulmona, L\'Aquila, Pescina, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Taglieri', 'Affiliation': 'Rehabilitation Service, ""Serafino Rinaldi"" Territorial Assistance Hospital of Pescina, ASL 01 Avezzano-Sulmona, L\'Aquila, Pescina, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': ""D'Elia"", 'Affiliation': 'Rehabilitation Service, ""Serafino Rinaldi"" Territorial Assistance Hospital of Pescina, ASL 01 Avezzano-Sulmona, L\'Aquila, Pescina, Italy.'}, {'ForeName': 'Cesidia', 'Initials': 'C', 'LastName': 'Centoletti', 'Affiliation': ""Rehabilitation Service ex Polio Centre, ASL 01 Avezzano-Sulmona, L'Aquila, Avezzano, Italy.""}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Di Carlo', 'Affiliation': ""Department of Life, Health & Environmental Sciences, School of Medicine, University of L'Aquila, L'Aquila, Italy.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4514-5']
1626,30322314,"Early intervention with cognitive behavioral therapy reduces sick leave duration in people with adjustment, anxiety and depressive disorders.","Background: Early intervention in workers diagnosed with mental disorders is associated with a lower incidence of relapse and shorter sick leave. However, no studies have been carried out on the effect of early intervention using an evidence-based therapy, Cognitive Behavioral Therapy (CBT), on people with sick leave. Aims: The objectives of the present study are to study whether the type of intervention (early or late) will affect the total duration of the sick leave, the partial duration of the sick leave, the duration of the psychotherapy and the time until return to work after the psychotherapy ends. The sample was composed of 167 participants who were on sick leave for adjustment disorders, anxiety disorders or depressive disorder. Results: The participants who had early intervention with CBT had a significantly shorter duration of total sick leave and partial sick leave, and a shorter time until returning to work after the psychotherapy ended than those who had late intervention. There were no statistically differences in the duration or efficacy of the psychotherapy. Conclusion: We can suggest that providing early access to CBT significantly reduces the length of sick leave in patients with mental disorders.",2020,"The participants who had early intervention with CBT had a significantly shorter duration of total sick leave and partial sick leave, and a shorter time until returning to work after the psychotherapy ended than those who had late intervention.","['167 participants who were on sick leave for adjustment disorders, anxiety disorders or depressive disorder', 'patients with mental disorders', 'people with sick leave', 'people with adjustment, anxiety and depressive disorders', 'workers diagnosed with mental disorders', 'participants who had early intervention with']","['Cognitive Behavioral Therapy (CBT', 'cognitive behavioral therapy', 'CBT']","['sick leave duration', 'duration or efficacy', 'shorter time until returning to work', 'shorter duration of total sick leave and partial sick leave', 'length of sick leave']","[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0001546', 'cui_str': 'Reactive Disorders'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",167.0,0.0734534,"The participants who had early intervention with CBT had a significantly shorter duration of total sick leave and partial sick leave, and a shorter time until returning to work after the psychotherapy ended than those who had late intervention.","[{'ForeName': 'José H', 'Initials': 'JH', 'LastName': 'Marco', 'Affiliation': 'Department of Personality, Assessment, and Psychological Treatments, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Alonso', 'Affiliation': 'Doctoral School of Catholic University of Valencia, Saint Vincent Martyr, Valencia, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Andani', 'Affiliation': 'Cathedra UMIVALE Innovation and Research in Pathology Work, Valencia, Spain.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2018.1521937']
1627,30446471,Is Sexual Function Better Preserved After Water Vapor Thermal Therapy or Medical Therapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia?,"BACKGROUND
Men often experience deterioration of sexual function after the use of α-blockers and 5-α reductase inhibitors for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia. Thus, an alternative treatment with water vapor thermal therapy (Rezūm System, Boston Scientific, Marlborough, MA, USA) which is an efficacious minimally invasive surgical treatment that preserves sexual function was examined.
AIM
To compare sexual function over 3 years after continuous daily treatment with pharmaceutical agents in the Medical Therapy of Prostatic Symptoms (MTOPS) study vs a single thermal therapy procedure (Rezūm study) in subjects with matched criteria for LUTS severity and prostate size.
METHODS
We used sexual function data from sexually active cohorts in the MTOPS study (1,209) randomized to doxazosin, finasteride, combination drugs and placebo, and sexually active men who received thermal therapy (86). MTOPS study participants completed the Brief Male Sexual Function Inventory; men in the Rezūm trial completed the International Index of Erectile Function and Male Sexual Health Questionnaire.
MAIN OUTCOME MEASURE
Estimated mean changes from baseline for sexual function variables were compared using a linear mixed repeated measures model with fixed effects for treatment and follow-up visits.
RESULTS
With continued daily drug use, men experienced significant worsening of sexual desire, erectile and ejaculatory function with finasteride and combination drug therapy, and reduced desire and erectile function with doxazosin. Thermal therapy was not associated with significant negative changes in sexual function throughout 3 years after treatment.
CLINICAL IMPLICATIONS
Water vapor thermal therapy can result in greater LUTS improvements than either doxazosin or finasteride alone, whereas combination drug therapy may equal that of this Rezūm procedure, but all drug therapies did have a significant negative impact on sexual function in contrast to the preservation of libido, erectile, and ejaculatory function after thermal therapy.
STRENGTH & LIMITATIONS
The report includes high-quality data from 2 large randomized controlled trials in subjects with similar baseline inclusion criteria for LUTS severity and prostate size. It is the first longitudinal assessment of sexual function domains restricted to sexually active men treated with drugs or a single minimally invasive surgical treatment with the Rezūm procedure. A limitation of the study is the use of 2 different, although validated sexual function inventories (Brief Male Sexual Function Inventory and International Index of Erectile Function).
CONCLUSION
A single water vapor thermal therapy procedure for targeted prostate tissue ablation for LUTS/ benign prostatic hyperplasia had no deleterious effect on 4 sexual function domains compared with appreciable worsening of sexual function after long-term single or combination drug use. McVary KT, Rogers T, Mahon J, et al. Is Sexual Function Better Preserved After Water Vapor Thermal Therapy or Medical Therapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia? J Sex Med 2018;15:1728-1738.",2018,A single water vapor thermal therapy procedure for targeted prostate tissue ablation for LUTS/ benign prostatic hyperplasia had no deleterious effect on 4 sexual function domains compared with appreciable worsening of sexual function after long-term single or combination drug use.,"['subjects with similar baseline inclusion criteria for LUTS severity and prostate size', 'sexually active men who received thermal therapy (86', 'subjects with matched criteria for LUTS severity and prostate size', 'sexually active cohorts in the MTOPS study (1,209) randomized to']","['water vapor thermal therapy (Rezūm System, Boston Scientific, Marlborough, MA, USA', 'α-blockers and 5-α reductase inhibitors', 'doxazosin', 'Water Vapor Thermal Therapy or Medical Therapy', 'doxazosin, finasteride, combination drugs and placebo', 'doxazosin or finasteride', 'finasteride']","['International Index of Erectile Function and Male Sexual Health Questionnaire', 'sexual desire, erectile and ejaculatory function', 'sexual function']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0426731', 'cui_str': 'Prostate size'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2350022', 'cui_str': 'Water Vapor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",1209.0,0.0253034,A single water vapor thermal therapy procedure for targeted prostate tissue ablation for LUTS/ benign prostatic hyperplasia had no deleterious effect on 4 sexual function domains compared with appreciable worsening of sexual function after long-term single or combination drug use.,"[{'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'McVary', 'Affiliation': 'Division of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL, USA. Electronic address: kmcvary@gmail.com.'}, {'ForeName': 'Tyson', 'Initials': 'T', 'LastName': 'Rogers', 'Affiliation': 'NAMSA, Minneapolis, MN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mahon', 'Affiliation': 'Division of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL, USA.'}, {'ForeName': 'Nikhil K', 'Initials': 'NK', 'LastName': 'Gupta', 'Affiliation': 'Division of Urology, Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2018.10.006']
1628,30230399,Randomized crossover feasibility trial of helminthic Trichuris suis ova versus placebo for repetitive behaviors in adult autism spectrum disorder.,"Objectives: Inflammatory mechanisms are implicated in the aetiology of autism spectrum disorder (ASD), and use of the immunomodulator Trichuris suis Ova (TSO) is a novel treatment approach. This pilot study determined the effect sizes for TSO versus placebo on repetitive behaviours, irritability and global functioning in adults with ASD. Methods: A 28-week double-blind, randomised two-period crossover study of TSO versus placebo in ten ASD adults, aged 17-35, was completed, with a 4-week washout between each 12-week period at Montefiore Medical Center, Albert Einstein College of Medicine. Subjects with ASD, history of seasonal, medication or food allergies, Y-BOCS ≥6 and IQ ≥70 received 2,500 TSO ova or matching placebo every 2 weeks of each 12-week period. Results: Large effect sizes for improvement in repetitive behaviours ( d = 1.0), restricted interests ( d = 0.82), rigidity ( d = 0.79) and irritability ( d = 0.78) were observed after 12 weeks of treatment. No changes were observed in the social-communication domain. Differences between treatment groups did not reach statistical significance. TSO had only minimal, non-serious side effects. Conclusions: This proof-of-concept study demonstrates the feasibility of TSO for the treatment of ASD, including a favourable safety profile, and moderate to large effect sizes for reducing repetitive behaviours and irritability. Clinicaltrials.gov: NCT01040221.",2020,"This pilot study determined the effect sizes for TSO versus placebo on repetitive behaviours, irritability and global functioning in adults with ASD.
","['adult autism spectrum disorder', 'Subjects with ASD, history of seasonal, medication or food allergies, Y-BOCS ≥6 and IQ ≥70 received 2,500', 'ten ASD adults, aged 17-35, was completed, with a 4-week washout between each 12-week period at Montefiore Medical Center, Albert Einstein College of Medicine', 'adults with ASD']","['TSO', 'TSO ova or matching placebo', 'TSO versus placebo', 'helminthic Trichuris suis ova versus placebo']","['social-communication domain', 'repetitive behaviours, irritability and global functioning', 'rigidity', 'repetitive behaviours and irritability', 'irritability', 'repetitive behaviours']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040955', 'cui_str': 'Trichocephalus'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026837', 'cui_str': 'Rigidity, Muscular'}]",,0.384337,"This pilot study determined the effect sizes for TSO versus placebo on repetitive behaviours, irritability and global functioning in adults with ASD.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hollander', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Uzunova', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Bonnie P', 'Initials': 'BP', 'LastName': 'Taylor', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Noone', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Racine', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Doernberg', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA.'}, {'ForeName': 'Casara Jean', 'Initials': 'CJ', 'LastName': 'Ferretti', 'Affiliation': 'Autism and Obsessive-Compulsive Spectrum Program, and Anxiety and Depression Research Program Department of Psychiatry and Behavioral Sciences Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2018.1523561']
1629,30246570,Comparison of the effect of narrative writing and art therapy on maternal stress in neonatal intensive care settings.,"Objective: This study was conducted to examine the effect of narrative writing and art therapy on maternal stress in the neonatal intensive care units (NICUs) during infants' hospitalization. Material and Methods: randomized controlled clinical trial with three parallel arms study was conducted among three groups of mothers with preterm infants in the NICUs of two teaching hospitals of Shahroud University of Medical Sciences. Pre- and post-tests were administered to a sample size of 105 during 9 months. The parental stressor scale (PSS) was used. The data were analyzed using descriptive and analytical statistical methods. Results: The mean maternal stress score was 54.94, 47.08, and 47.57 in the art therapy, narrative writing, and control before the intervention respectively, indicating no significant difference between the groups ( p = .28). There was also no significant difference in the mean score of stress between the groups after the intervention ( p = .92). Also, we found no significant difference in the mean score of parental role and parents' relationship and sights and sounds between the three groups on the second day ( p = .22 and p = .12, respectively) but there was a significant difference in the mean score of infant behavior and appearance between the three groups ( p = .05). There was no significant difference in parental role and parents' relationship ( p = .31), infant behavior and appearance ( p = .58), and sights and sounds ( p = .67) between the three groups on the sixth day of intervention. Conclusions: Narrative writing and art therapy are only effective on the subscale of infant behavior and appearance in the PSS: NICU.",2020,There was also no significant difference in the mean score of stress between the groups after the intervention (p = .92).,"[""maternal stress in the neonatal intensive care units (NICUs) during infants' hospitalization"", 'three groups of mothers with preterm infants in the NICUs of two teaching hospitals of Shahroud University of Medical Sciences', 'neonatal intensive care settings']",['narrative writing and art therapy'],"['infant behavior and appearance', 'mean maternal stress score', 'mean score of infant behavior and appearance', ""parental role and parents' relationship"", 'maternal stress', ""mean score of parental role and parents' relationship and sights and sounds"", 'mean score of stress', 'parental stressor scale (PSS']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021711', 'cui_str': 'Infant, Newborn, Intensive Care'}]","[{'cui': 'C0003827', 'cui_str': 'Art Therapy'}]","[{'cui': 'C0242952', 'cui_str': 'Infant Behavior'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0222045'}]",,0.0328884,There was also no significant difference in the mean score of stress between the groups after the intervention (p = .92).,"[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Jouybari', 'Affiliation': 'Nursing Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Ezzat', 'Initials': 'E', 'LastName': 'Abbariki', 'Affiliation': 'School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Jebeli', 'Affiliation': 'Department of Adult Health Nursing, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mehravar', 'Affiliation': 'Clinical Research Development Unit (CRDU), 5th Azar Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Asadi', 'Affiliation': 'Department of Reproductive Health Research and Midwifery Consultation, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Negarin', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Nursing Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Sanagoo', 'Affiliation': 'Nursing Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moradi', 'Affiliation': 'Department of Nursing, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1499719']
1630,31813076,"Effects of Depression, Stigma and Intimate Partner Violence on Postpartum Women's Adherence and Engagement in HIV Care in Kenya.","We explored the association between HIV-related stigma and experiences of intimate partner violence (IPV) and depression with viral load suppression, and medication and visit adherence in postpartum women receiving lifelong antiretroviral therapy (ART) (N = 200). We administered a cross-sectional survey to 200 women with HIV at 12 months postpartum who were enrolled in the MOTIVATE trial. The MOTIVATE study is a cluster-randomized trial evaluating the impact of community mentor mothers and text messaging on PMTCT outcomes in southwestern Kenya. Simple and multivariable logistic regression analysis was performed in STATA. Women who experienced stigma or IPV were more likely to miss clinic visits (internalized stigma aOR 1.30 95%CI 1.03-1.64; anticipated stigma aOR 1.20 95%CI 1.04-1.42; IPV aOR 15.71 95%CI 1.47-167.80), report difficulty taking ART drugs (internalized stigma aOR 1.32 95%CI 1.10-1.58; anticipated stigma aOR 1.14 95%CI 1.01-1.30) and not taking medication as prescribed (IPV aOR 2.00 95%CI 1.05-3.74). Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76). There is need to develop tailored psychosocial interventions within PMTCT programs that appropriately address mental health, stigma, and violence.",2020,Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76).,"['postpartum women receiving lifelong antiretroviral therapy (ART) (N\u2009=\u2009200', '200 women with HIV at 12\xa0months postpartum who were enrolled', 'community mentor mothers and text messaging on PMTCT outcomes in southwestern Kenya', ""Postpartum Women's Adherence and Engagement in HIV Care in Kenya""]",[],"['Depression', 'HIV-related stigma and experiences of intimate partner violence (IPV) and depression with viral load suppression, and medication and visit adherence', 'viral load suppression', 'Depression, Stigma and Intimate Partner Violence', 'stigma or IPV', 'miss clinic visits']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",200.0,0.173199,Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76).,"[{'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya. maricianah@gmail.com.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Odwar', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Abuogi', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Aurora, CO, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Owuor', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hampanda', 'Affiliation': 'Center for Global Health, Colorado School of Public Health, Aurora, CO, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02750-y']
1631,31652404,"Impact of 24-h high and low fermentable oligo-, di-, monosaccharide, and polyol diets on markers of exercise-induced gastrointestinal syndrome in response to exertional heat stress.","The study aimed to determine the effects of 24-h high (HFOD) and low (LFOD) fermentable oligo-, di-, monosaccharide, and polyol (FODMAP) diets before exertional heat stress on gastrointestinal integrity, function, and symptoms. Eighteen endurance runners consumed a HFOD and a LFOD (double-blind crossover design) before completing 2 h of running at 60% maximal oxygen uptake in 35 °C ambient temperature. Blood samples were collected before and after exercise to determine plasma cortisol and intestinal fatty acid binding protein (I-FABP) concentrations, and bacterial endotoxin and cytokine profiles. Breath hydrogen (H 2 ) and gastrointestinal symptoms (GIS) were determined pre-exercise, every 15 min during, and in recovery. No differences were observed for plasma cortisol concentration between diets. Plasma I-FABP concentration was lower on HFOD compared with LFOD ( p = 0.033). A trend for lower lipopolysaccharide binding protein ( p = 0.088), but not plasma soluble CD14 ( p = 0.478) and cytokine profile ( p > 0.05), responses on HFOD was observed. A greater area under the curve breath H 2 concentration ( p = 0.031) was observed throughout HFOD (mean and 95% confidence interval: HFOD 2525 (1452-3597) ppm·4 h -1 ) compared with LFOD (1505 (1031-1978) ppm·4 h -1 ). HFOD resulted in greater severity of GIS compared with LFOD (pre-exercise, p = 0.017; during, p = 0.035; and total, p = 0.014). A 24-h HFOD before exertional heat stress ameliorates disturbances to epithelial integrity but exacerbates carbohydrate malabsorption and GIS severity in comparison with a LFOD. Novelty Twenty-four-hour high FODMAP diet ameliorated disturbances to gastrointestinal integrity. Twenty-four-hour high FODMAP diet results in greater carbohydrate malabsorption compared with low FODMAP diet. Incidence of GIS during exertional heat stress were pronounced on both low and high FODMAP diets, but greater GIS severity was observed with high FODMAP diet.",2020,"HFOD resulted in greater severity of GIS, compared to LFOD (pre-exercise p=0.017, during p=0.035, and total p=0.014).",['Eighteen endurance runners'],"['24-hour high and low fermentable oligo- di- mono- saccharide polyol diets', '24-h high (HFOD) and low (LFOD) fermentable oligo- di- mono- saccharide and polyol diets', 'FODMAP diet', 'HFOD']","['plasma cortisol and I-FABP concentrations, and bacterial endotoxin and cytokine profiles', 'GIS severity', 'plasma sCD14', 'AUC breath H2 concentration', 'Breath hydrogen (H2) and gastrointestinal symptoms (GIS', 'disturbances to gastrointestinal integrity', 'carbohydrate malabsorption', 'HFOD and LFOD', 'cytokine profile', 'severity of GIS', 'gastrointestinal integrity, function, and symptoms', 'HFOD', 'Plasma I-FABP concentration', 'plasma cortisol concentration']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1137305', 'cui_str': 'oligo(caprolactone)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0007004', 'cui_str': 'Carbohydrates'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4552346', 'cui_str': 'FODMAP diet'}]","[{'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption Syndrome'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",18.0,0.0319401,"HFOD resulted in greater severity of GIS, compared to LFOD (pre-exercise p=0.017, during p=0.035, and total p=0.014).","[{'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Gaskell', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria 3168, Australia.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria 3168, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology - The Alfred Hospital, Monash University, Melbourne, Victoria 3004, Australia.'}, {'ForeName': 'Ricardo J S', 'Initials': 'RJS', 'LastName': 'Costa', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria 3168, Australia.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0187']
1632,30312411,Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease.,"Aims
Coronary computed tomography angiography (CTA) has emerged as a non-invasive diagnostic method for patients with suspected coronary artery disease, but its usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the agreement between separate heart teams on treatment decision-making based on either coronary CTA or conventional angiography.
Methods and results
Separate heart teams composed of an interventional cardiologist, a cardiac surgeon, and a radiologist were randomized to assess the coronary artery disease with either coronary CTA or conventional angiography in patients with de novo left main or three-vessel coronary artery disease. Each heart team, blinded for the other imaging modality, quantified the anatomical complexity using the SYNTAX score and integrated clinical information using the SYNTAX Score II to provide a treatment recommendations based on mortality prediction at 4 years: coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or equipoise between CABG and PCI. The primary endpoint was the agreement between heart teams on the revascularization strategy. The secondary endpoint was the impact of fractional flow reserve derived from coronary CTA (FFRCT) on treatment decision and procedural planning. Overall, 223 patients were included. A treatment recommendation of CABG was made in 28% of the cases with coronary CTA and in 26% with conventional angiography. The agreement concerning treatment decision between coronary CTA and conventional angiography was high (Cohen's kappa 0.82, 95% confidence interval 0.74-0.91). The heart teams agreed on the coronary segments to be revascularized in 80% of the cases. FFRCT was available for 869/1108 lesions (196/223 patients). Fractional flow reserve derived from coronary CTA changed the treatment decision in 7% of the patients.
Conclusion
In patients with left main or three-vessel coronary artery disease, a heart team treatment decision-making based on coronary CTA showed high agreement with the decision derived from conventional coronary angiography suggesting the potential feasibility of a treatment decision-making and planning based solely on this non-invasive imaging modality and clinical information.
Trial registration number
NCT02813473.",2018,"The agreement concerning treatment decision between coronary CTA and conventional angiography was high (Cohen's kappa 0.82, 95% confidence interval 0.74-0.91).","['223 patients were included', 'patients with left main or three-vessel coronary artery disease, a heart team treatment decision-making based on coronary CTA', 'patients with de novo left main or three-vessel coronary artery disease', 'patients with suspected coronary artery disease', 'patients with complex coronary artery disease', 'multivessel coronary artery disease']","['Coronary computed tomography angiography', 'coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI', 'FFRCT', 'coronary CTA or conventional angiography', 'CABG', 'Coronary computed tomography angiography (CTA']","['Fractional flow reserve', 'agreement between heart teams on the revascularization strategy', 'fractional flow reserve derived from coronary CTA (FFRCT) on treatment decision and procedural planning']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0442842', 'cui_str': 'Conventional angiography (qualifier value)'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",223.0,0.0466347,"The agreement concerning treatment decision between coronary CTA and conventional angiography was high (Cohen's kappa 0.82, 95% confidence interval 0.74-0.91).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Collet', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Doctor Molewaterplein 40, GD Rotterdam, the Netherlands.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Andreini', 'Affiliation': 'Centro Cardiologico Monzino, University of Milan, Via Carlo Parea, 4, Milano, Italy.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Sonck', 'Affiliation': 'Department of Cardiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, Jette, Brussel, Belgium.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Pompilio', 'Affiliation': 'Centro Cardiologico Monzino, University of Milan, Via Carlo Parea, 4, Milano, Italy.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Mushtaq', 'Affiliation': 'Centro Cardiologico Monzino, University of Milan, Via Carlo Parea, 4, Milano, Italy.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'La Meir', 'Affiliation': 'Department of Cardiology, University of Zurich, Rämistrasse 71, Zürich, Switzerland.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Doctor Molewaterplein 40, GD Rotterdam, the Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'de Mey', 'Affiliation': 'Department of Radiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, Jette, Brussel, Belgium.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gaemperli', 'Affiliation': 'Department of Cardiology, University of Zurich, Rämistrasse 71, Zürich, Switzerland.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Ouda', 'Affiliation': 'Department of Cardiovascular Surgery, University of Zurich, Rämistrasse 71, Zürich, Switzerland.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Maureira', 'Affiliation': 'Department of Cardiovascular Surgery, CHRU Nancy and University of Lorraine, Avenue du Maréchal de Lattre, Rue Charles Welche, Nancy, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Mandry', 'Affiliation': 'Department of Radiology, CHRU Nancy and University of Lorraine, Avenue du Maréchal de Lattre, Rue Charles Welche, Nancy, France.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Camenzind', 'Affiliation': 'Department of Cardiology, CHRU Nancy and University of Lorraine, Avenue du Maréchal de Lattre, Rue Charles Welche, Nancy, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macron', 'Affiliation': 'Department of Cardiology, Centre cardiologique du nord, 36 Rue des Moulins Gémeaux, Saint-Denis, France.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Department of Cardiovascular Surgery, Jena University Hospital, Friedrich Schiller University of Jena, Fürstengraben 1, Jena, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'Department of Radiology, Jena University Hospital, Friedrich Schiller University of Jena, Fürstengraben 1, Jena, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Sigusch', 'Affiliation': 'Department of Cardiology, Heinrich Braun Klinikum, Karl-Keil-Straße 35, Zwickau, Germany.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Asano', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Katagiri', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Marie-Angele', 'Initials': 'MA', 'LastName': 'Morel', 'Affiliation': 'Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Doctor Molewaterplein 40, GD Rotterdam, the Netherlands.'}, {'ForeName': 'Wietze', 'Initials': 'W', 'LastName': 'Lindeboom', 'Affiliation': 'Cardialysis BV, Westblaak 98, KM Rotterdam, the Netherlands.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pontone', 'Affiliation': 'Centro Cardiologico Monzino, University of Milan, Via Carlo Parea, 4, Milano, Italy.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Lüscher', 'Affiliation': 'Department of Cardiovascular Surgery, University of Zurich, Rämistrasse 71, Zürich, Switzerland.'}, {'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'Bartorelli', 'Affiliation': 'Centro Cardiologico Monzino, University of Milan, Via Carlo Parea, 4, Milano, Italy.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, Royal Brompton and Harefield Hospitals, Imperial College of London, Kensington, London, UK.'}]",European heart journal,['10.1093/eurheartj/ehy581']
1633,30277457,Apathy alters emotional arousal in chronic schizophrenia.,"BACKGROUND
Within the heterogeneity of schizophrenia, apathy constitutes an independent cluster of negative symptoms associated with poor outcomes. Attempts to identify an emotional deficit in patients who have schizophrenia with negative symptoms have yielded mixed results, and studies that focus on the relationship between apathy and emotional disorders are lacking.
METHODS
We set out to remedy this shortcoming using a validated battery of film excerpts to induce positive and negative emotions in patients with chronic schizophrenia with ( n = 20) or without ( n = 20) apathy, and in controls ( n = 20) comparable for age, sex and socioeconomic status. We assessed emotions using an innovative but validated technique to evaluate tonic and phasic electrodermal activity and subjective feelings using a standardized visual analogue scale.
RESULTS
Using a qualitative measure of apathy, we did not find a specific decrease in tonic activity during the induction of positive emotions. However, we did observe that patients with apathy showed reduced tonic activity independent of valence (i.e., for both positive and negative emotions) compared with controls and patients without apathy. Moreover, the quantitative measure of apathy (Apathy Evaluation Scale) was the only significant factor, explaining 24% of the variance in tonic activity during induction of positive emotions after controlling for confounding factors.
LIMITATIONS
Electrodermal activity was the only physiologic measure we acquired. We induced several emotions sequentially that might have overlapped with each other, but we added an emotional ""washout"" period and randomized the order of each film excerpt to limit this possibility.
CONCLUSION
Taken together, these results suggest that apathy in schizophrenia could impair tonic activity during positive emotions. Treatments aimed at enhancing positive emotions may help alleviate apathy in schizophrenia.",2018,"Using a qualitative measure of apathy, we did not find a specific decrease in tonic activity during the induction of positive emotions.","['patients with chronic schizophrenia with ( n = 20) or without ( n = 20) apathy, and in controls ( n = 20) comparable for age, sex and socioeconomic status', 'patients who have schizophrenia with negative symptoms', 'chronic schizophrenia']",[],"['quantitative measure of apathy (Apathy Evaluation Scale', 'tonic activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia (disorder)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.041415,"Using a qualitative measure of apathy, we did not find a specific decrease in tonic activity during the induction of positive emotions.","[{'ForeName': 'Thibaut', 'Initials': 'T', 'LastName': 'Dondaine', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Philippot', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Batail', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Le Jeune', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}, {'ForeName': 'Md PhD Paul', 'Initials': 'MPP', 'LastName': 'Sauleau', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Drapier', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vérin', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}, {'ForeName': 'Md PhD Bruno', 'Initials': 'MPB', 'LastName': 'Millet', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Drapier', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Robert', 'Affiliation': 'From the University Department of Psychiatry, Guillaume Régnier Hospital, Rennes, France (Batail, D. Drapier, Robert); University of Lille, Inserm, CHU Lille, U1171, Degenerative and Vascular Cognitive Disorders, F-59000, Lille, France (Dondaine); Behaviour and Basal Ganglia Laboratory (EA 4712), University of Rennes, Rennes, France (Batail, Le Jeune, Sauleau, S. Drapier, Vérin, D. Drapier, Robert); Eugène Marquis Centre, Rennes, France (Le Jeune); Neurophysiology Department, Rennes University Hospital, Rennes, France (Sauleau); Movement Disorders Unit, Rennes University Hospital, Rennes, France (S. Drapier, Vérin); Psychiatry Department, Pitié-Salpêtrière Hospital, Paris, France (Millet); University of Louvain-la-Neuve, Louvain-la-Neuve, Belgium (Philippot).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.170172']
1634,30270415,Biophysical skin measurements to evaluate the effectiveness of photobiomodulation therapy in the prevention of acute radiation dermatitis in breast cancer patients.,"PURPOSE
The purpose of this study was to evaluate objectively the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) by using biophysical skin measurements.
METHODS
A randomized, placebo-controlled trial with 120 breast cancer patients who underwent an identical radiotherapy (RT) regimen post-lumpectomy was performed (TRANSDERMIS trial). Patients were randomized to receive PBM (808 nm CW/905 nm pulsed, 168 mW/cm 2 , spot size 19.6 cm 2 , fluence 4 J/cm 2 ) or placebo treatments from the first day of RT (2×/week). Biophysical skin measurements were collected to assess the skin pigmentation and barrier function. Measurements were collected at the first day of RT, a RT dose of 40 Gray (Gy), and the end of RT (66 Gy).
RESULTS
The incidence of moist desquamation was significantly higher in the control than in the PBMT group at the end of RT (30 vs. 7%, respectively, odds ratio = 6, p = 0.004). The biophysical skin measures showed that the mean percentage change from the baseline transepidermal water loss (TEWL), erythema, and melanin values was significantly higher in the control than in the PBMT group at the end of RT (ps < 0.05). Logistic regression analysis revealed that the risk on moist desquamation was significantly increased for patients with a large (> 800 cc) breast volume (odds ratio = 4, p = 0.017).
CONCLUSIONS
This is the first randomized controlled trial demonstrating by objective measurements that PBMT is effective in reducing the incidence of moist desquamation in breast cancer patients undergoing RT. Additionally, a large breast volume is an important risk factor for the development of moist desquamation.",2019,"The incidence of moist desquamation was significantly higher in the control than in the PBMT group at the end of RT (30 vs. 7%, respectively, odds ratio = 6, p = 0.004).","['120 breast cancer patients who underwent an identical radiotherapy (RT) regimen post-lumpectomy was performed (TRANSDERMIS trial', 'breast cancer patients', 'acute radiation dermatitis (ARD', 'breast cancer patients undergoing RT']","['placebo', 'photobiomodulation therapy', 'PBM (808\xa0nm CW/905', 'photobiomodulation therapy (PBMT', 'PBMT']","['baseline transepidermal water loss (TEWL), erythema, and melanin values', 'risk on moist desquamation', 'Biophysical skin measurements', 'incidence of moist desquamation', 'skin pigmentation and barrier function']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis (disorder)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0237849', 'cui_str': 'Scaling of skin'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1269684', 'cui_str': 'Skin pigmented'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",120.0,0.0749244,"The incidence of moist desquamation was significantly higher in the control than in the PBMT group at the end of RT (30 vs. 7%, respectively, odds ratio = 6, p = 0.004).","[{'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'Robijns', 'Affiliation': 'Faculty of Medicine & Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium. jolien.robijns@uhasselt.be.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Censabella', 'Affiliation': 'Department of Medical Oncology, Jessa Hospital, Stadsomvaart 11, Hasselt, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Claes', 'Affiliation': 'Limburg Oncology Centre, Jessa Hospital, Stadsomvaart 11, Hasselt, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Pannekoeke', 'Affiliation': 'Limburg Oncology Centre, Jessa Hospital, Stadsomvaart 11, Hasselt, Belgium.'}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Bussé', 'Affiliation': 'Faculty of Medicine & Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Colson', 'Affiliation': 'Faculty of Medicine & Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kaminski', 'Affiliation': 'Faculty of Medicine & Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Lodewijckx', 'Affiliation': 'Faculty of Medicine & Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bulens', 'Affiliation': 'Department of Medical Oncology, Jessa Hospital, Stadsomvaart 11, Hasselt, Belgium.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Maes', 'Affiliation': 'Department of Medical Oncology, Jessa Hospital, Stadsomvaart 11, Hasselt, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Noé', 'Affiliation': 'Department of Medical Oncology, Jessa Hospital, Stadsomvaart 11, Hasselt, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Brosens', 'Affiliation': 'Department of Medical Oncology, Jessa Hospital, Stadsomvaart 11, Hasselt, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Dermatology, Jessa Hospital, Stadsomvaart 11, Hasselt, Belgium.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Lambrichts', 'Affiliation': 'Faculty of Medicine & Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Somers', 'Affiliation': 'Faculty of Medicine & Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Mebis', 'Affiliation': 'Faculty of Medicine & Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4487-4']
1635,30214264,"Daily intake of Kaempferia parviflora extract decreases abdominal fat in overweight and preobese subjects: a randomized, double-blind, placebo-controlled clinical study.","Purpose
Obesity is a serious problem, which is now a worldwide health problem. Kaempferia parviflora extract (KPE) exhibits anti-obesity effects in animals. However, as no clinical trials have evaluated the anti-obesity effects of KPE in humans, we examined the effects of KPE in reducing abdominal fat in overweight and preobese Japanese subjects.
Materials and methods
A 12-week, single-center, randomized, double-blind, placebo-controlled clinical trial was conducted. Seventy-six subjects (males and females aged 20 to <65 years) with a body mass index ≥24 and <30 kg/m 2 were randomly assigned into two groups. The subjects in each group ingested one capsule of placebo or active KPE (containing 150 mg of KPE) once daily for 12 weeks. The primary outcome was reduction in visceral fat area as determined by computed tomography scanning. The key secondary outcomes were reductions in subcutaneous fat area and total fat area. Subgroup analysis was also performed in healthy subjects without dyslipidemia, hypertension, or hyperglycemia. The safety of KPE ingestion was also evaluated.
Results
Compared with the placebo group, the active KPE group exhibited significant reduction in abdominal fat area (visceral, subcutaneous, and total fat) and triglyceride levels after 12 weeks. Subgroup analyses demonstrated a significant reduction in abdominal fat area and triglyceride levels in healthy subjects compared with the placebo group after 12 weeks. Neither group exhibited adverse events related to the test foods or clinically relevant abnormal changes in physical, biochemical, or hematologic parameters, or in urinalysis results and medical interview.
Conclusion
Daily ingestion of KPE safely reduces body fat, particularly abdominal fat, in Japanese overweight and preobese subjects.",2018,"Neither group exhibited adverse events related to the test foods or clinically relevant abnormal changes in physical, biochemical, or hematologic parameters, or in urinalysis results and medical interview.
","['healthy subjects without dyslipidemia, hypertension, or hyperglycemia', 'Seventy-six subjects (males and females aged 20 to <65 years) with a body mass index ≥24 and <30 kg/m 2', 'healthy subjects', 'overweight and preobese subjects', 'animals', 'overweight and preobese Japanese subjects', 'Japanese overweight and preobese subjects']","['active KPE', 'placebo', 'Kaempferia parviflora extract (KPE', 'KPE', 'placebo or active KPE (containing 150 mg of KPE', 'Kaempferia parviflora extract']","['physical, biochemical, or hematologic parameters, or in urinalysis results and medical interview', 'abdominal fat area (visceral, subcutaneous, and total fat) and triglyceride levels', 'abdominal fat area and triglyceride levels', 'adverse events', 'reduction in visceral fat area as determined by computed tomography scanning', 'subcutaneous fat area and total fat area']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1044692', 'cui_str': 'Kaempferia'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}]",,0.266602,"Neither group exhibited adverse events related to the test foods or clinically relevant abnormal changes in physical, biochemical, or hematologic parameters, or in urinalysis results and medical interview.
","[{'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Yoshino', 'Affiliation': 'Research and Development Division, Research Center, Maruzen Pharmaceuticals Co., Ltd., Hiroshima, Japan, s-yoshino@maruzenpcy.co.jp.'}, {'ForeName': 'Riyo', 'Initials': 'R', 'LastName': 'Awa', 'Affiliation': 'Research and Development Division, Research Center, Maruzen Pharmaceuticals Co., Ltd., Hiroshima, Japan, s-yoshino@maruzenpcy.co.jp.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Miyake', 'Affiliation': 'Research and Development Division, Research Center, Maruzen Pharmaceuticals Co., Ltd., Hiroshima, Japan, s-yoshino@maruzenpcy.co.jp.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Fukuhara', 'Affiliation': 'Fukuhara Clinic, Hokkaido, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Department, New Drug Research Center, Inc., Hokkaido, Japan.'}, {'ForeName': 'Toyotada', 'Initials': 'T', 'LastName': 'Ashino', 'Affiliation': 'Clinical Research Department, New Drug Research Center, Inc., Hokkaido, Japan.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Tomita', 'Affiliation': 'Clinical Research Department, New Drug Research Center, Inc., Hokkaido, Japan.'}, {'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Kuwahara', 'Affiliation': 'Research and Development Division, Research Center, Maruzen Pharmaceuticals Co., Ltd., Hiroshima, Japan, s-yoshino@maruzenpcy.co.jp.'}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S169925']
1636,30100840,Ultrasound-guided bilateral superficial cervical plexus block for thyroid surgery: The effect of dexmedetomidine addition to bupivacaine-epinephrine.,"Background
The thyroid gland surgery is a common and painful procedure demanding analgesia. Many regional techniques are applied for anterior neck surgeries mostly assigned in relation to the involved cervical fascia. Dexmedetomidine (Precedex) is a selective alpha 2 adrenoceptor agonist which prolongs the sensory blockade duration of local anesthetics. Our study hypothesis is that ultrasound (US)-guided bilateral superficial cervical plexus block (BSCPB) may provide longer analgesia when adding dexmedetomidine to bupivacaine-epinephrine.
Purpose
The aim of this study is to evaluate the analgesic efficacy and possible side effects of US-guided BSCPB and the effect of dexmedetomidine addition to bupivacaine-epinephrine in patients undergoing thyroid surgery.
Methods
This prospective, double-blind, randomized study was performed on 42 patients randomized into two equal groups each of 21; bupivacaine Group B and dexmedetomidine Group D. Patients with contraindications to regional anesthesia or uncontrolled comorbidities were excluded from the study. Total pethidine consumption in 24 h is the primary outcome. The visual analog scale, timing of the first opioid request, and hemodynamics are the secondary outcomes.
Results
In Group D, there was a longer time to the first request of opioid postoperatively, a lower total pethidine consumption and pain score postoperatively, and lower fentanyl requirements intraoperatively.
Conclusions
Sonographic-guided bilateral SCPB using a combination of bupivacaine, dexmedetomidine, and epinephrine was superior to bupivacaine for prolonged analgesia with less intra- and postoperative opioid consumption and lower side effect profile during thyroid surgery.",2018,"In Group D, there was a longer time to the first request of opioid postoperatively, a lower total pethidine consumption and pain score postoperatively, and lower fentanyl requirements intraoperatively.
","['patients undergoing thyroid surgery', 'Group D. Patients with contraindications to regional anesthesia or uncontrolled comorbidities were excluded from the study', 'thyroid surgery', '42 patients randomized into two equal groups each of 21']","['bupivacaine Group B and dexmedetomidine', 'ultrasound ', 'bupivacaine-epinephrine', 'Dexmedetomidine (Precedex', 'US)-guided bilateral superficial cervical plexus block (BSCPB', 'bupivacaine', 'dexmedetomidine', 'Ultrasound-guided bilateral superficial cervical plexus block', 'bupivacaine, dexmedetomidine, and epinephrine']","['analgesic efficacy', 'visual analog scale, timing of the first opioid request, and hemodynamics', 'Total pethidine consumption', 'total pethidine consumption and pain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0876757', 'cui_str': 'Precedex'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block (procedure)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",42.0,0.147897,"In Group D, there was a longer time to the first request of opioid postoperatively, a lower total pethidine consumption and pain score postoperatively, and lower fentanyl requirements intraoperatively.
","[{'ForeName': 'Alaa Eldin Adel', 'Initials': 'AEA', 'LastName': 'Elmaddawy', 'Affiliation': 'Department of Anesthesia, Pain Management, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Alaa Eldin', 'Initials': 'AE', 'LastName': 'Mazy', 'Affiliation': 'Department of Anesthesia, Pain Management, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_653_17']
1637,30189768,Patient preferences for method of cesarean skin closure: secondary outcomes from a randomized trial.,"Objective: To assess patient preference for sutures or staples for cesarean wound closure. Methods: This is a planned secondary analysis of a randomized controlled trial of 746 women in which suture and staples were compared for cesarean skin closure. Enrolled patients were asked to complete preoperative and postoperative surveys to assess preferred closure. Reasons for expressed preferences were elicited for each patient. Preferences were stratified by a number of cesarean deliveries (CD). We sought to determine if patients had a specific preference for wound closure due to personal experience or a personal belief that one method may be more beneficial with respect to pain and appearance. Results: We surveyed 550 patients preoperatively and 627 postoperatively. Women with a prior CD were more likely to have a skin closure preference compared with women having a primary CD ( p < .05). Women who had a prior closure with suture rather than staples were significantly more likely to have a preference for the same wound closure method ( p < .01). Avoiding the need for staple removal was the main reason women preferred suture closure, both preoperatively and postoperatively. The higher the number of the previous CD, the greater the preference for future closure with suture over staples ( p < .05). Conclusions: Women undergoing cesarean delivery prefer suture as the method for skin closure compared with staples.",2020,"The higher the number of the previous CD, the greater the preference for future closure with suture over staples (p < .05).
","['746 women in which suture and staples were compared for cesarean skin closure', '550 patients preoperatively and 627 postoperatively']",['cesarean skin closure'],"['number of cesarean deliveries (CD', 'skin closure preference']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",746.0,0.0596938,"The higher the number of the previous CD, the greater the preference for future closure with suture over staples (p < .05).
","[{'ForeName': 'Adeeb', 'Initials': 'A', 'LastName': 'Khalifeh', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jonah', 'Initials': 'J', 'LastName': 'Fleisher', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gressel', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Berghella', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leiby', 'Affiliation': 'Department of Biostatistics, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'A Dhanya', 'Initials': 'AD', 'LastName': 'Mackeen', 'Affiliation': 'Department of Obstetrics and Gynecology, Geisinger Health System, Danville, PA, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1497594']
1638,30101300,"Blood pressure, heart rate, and mortality in chronic obstructive pulmonary disease: the SUMMIT trial.","Aims
To characterize the relationship between blood pressure (BP) or heart rate and mortality and morbidity in chronic obstructive pulmonary disease (COPD).
Methods and results
We performed post hoc analysis of baseline BP or heart rate and all-cause mortality and cardiovascular events in the SUMMIT trial. SUMMIT was a randomized double-blind outcome trial of 16 485 participants (65 ± 8 years, 75% male, and 47% active smokers) enrolled at 1368 sites in 43 countries. Participants with moderate COPD with or at risk for cardiovascular disease (CVD) were randomized to placebo, long-acting beta agonist, inhaled corticosteroid, or their combination. All-cause mortality increased in relation to high systolic [≥140 mmHg; hazard ratio (HR) 1.27, 95% confidence interval (CI) 1.12-1.45] or diastolic (≥90 mmHg; HR 1.35, 95% CI 1.14-1.59) BP and low systolic (<120 mmHg; HR 1.36, 95% CI 1.13-1.63) or diastolic (<80 mmHg; HR 1.15, 95% CI 1.00-1.32) BP. Higher heart rates (≥80 per minute; HR 1.39, 95% CI 1.21-1.60) and pulse pressures (≥80 mmHg; HR 1.39, 95% CI 1.07-1.80) were more linearly related to increases in all-cause mortality. The risks of cardiovascular events followed similar patterns to all-cause mortality. Similar findings were observed in subgroups of patients without established CVD.
Conclusion
A 'U-shaped' relationship between BP and all-cause mortality and cardiovascular events exists in patients with COPD and heightened cardiovascular risk. A linear relationship exists between heart rate and all-cause mortality and cardiovascular events in this population. These findings extend the prognostic importance of BP to this growing group of patients and raise concerns that both high and low BP may pose health risks.",2018,"Higher heart rates (≥80 per minute; HR 1.39, 95% CI 1.21-1.60) and pulse pressures (≥80 mmHg; HR 1.39, 95% CI 1.07-1.80) were more linearly related to increases in all-cause mortality.","['Participants with moderate COPD with or at risk for cardiovascular disease (CVD', '16\xa0485 participants (65\u2009±\u20098\u2009years, 75% male, and 47% active smokers) enrolled at 1368 sites in 43 countries', 'chronic obstructive pulmonary disease', 'patients with COPD and heightened cardiovascular risk', 'chronic obstructive pulmonary disease (COPD']","['placebo, long-acting beta agonist, inhaled corticosteroid, or their combination']","['blood pressure (BP) or heart rate and mortality and morbidity', 'Blood pressure, heart rate, and mortality', 'baseline BP or heart rate and all-cause mortality and cardiovascular events', 'BP and low systolic', 'pulse pressures', 'risks of cardiovascular events', 'Higher heart rates']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442803', 'cui_str': 'Heightened (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16485.0,0.336138,"Higher heart rates (≥80 per minute; HR 1.39, 95% CI 1.21-1.60) and pulse pressures (≥80 mmHg; HR 1.39, 95% CI 1.07-1.80) were more linearly related to increases in all-cause mortality.","[{'ForeName': 'James Brian', 'Initials': 'JB', 'LastName': 'Byrd', 'Affiliation': 'University of Michigan Health System, 1500 E Medical Center Dr, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Anderson', 'Affiliation': 'Research & Development, GlaxoSmithKilne, Stockley Park, Iron Bridge Rd N, West Drayton, Uxbridge UB11 1BT, Middlesex, UK.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Department of Medicine, Clinical Sciences Centre, University Hospital Aintree, University of Liverpool, Cedar House, Ashton Street, Liverpool L69 3GE, Liverpool, UK.'}, {'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Cowans', 'Affiliation': 'Veramed Ltd., 5th Floor Regal House, 70 London Road, Twickenham TW1 3QS, UK.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'Research & Development, GlaxoSmithKilne, Stockley Park, Iron Bridge Rd N, West Drayton, Uxbridge UB11 1BT, Middlesex, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Weill Cornell Medicine, 525 East 68th Street, Box 130, New York, NY 10065, USA.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester and South Manchester, 2nd Floor Education and Research Centre, University Hospital of South Manchester NHS Foundation Trust, Manchester M23 9LT, Manchester, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Yates', 'Affiliation': 'Research & Development, GlaxoSmithKilne, Stockley Park, Iron Bridge Rd N, West Drayton, Uxbridge UB11 1BT, Middlesex, UK.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'University of Michigan Health System, 1500 E Medical Center Dr, Ann Arbor, MI 48109, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehy451']
1639,30158069,"Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial.","BACKGROUND
The use of aspirin in the primary prevention of cardiovascular events remains controversial. We aimed to assess the efficacy and safety of aspirin versus placebo in patients with a moderate estimated risk of a first cardiovascular event.
METHODS
ARRIVE is a randomised, double-blind, placebo-controlled, multicentre study done in seven countries. Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors. We excluded patients at high risk of gastrointestinal bleeding or other bleeding, or diabetes. Patients were randomly assigned (1:1) with a computer-generated randomisation code to receive enteric-coated aspirin tablets (100 mg) or placebo tablets, once daily. Patients, investigators, and others involved in treatment or data analysis were masked to treatment allocation. The primary efficacy endpoint was a composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischaemic attack. Safety endpoints were haemorrhagic events and incidence of other adverse events, and were analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00501059.
FINDINGS
Between July 5, 2007, and Nov 15, 2016, 12 546 patients were enrolled and randomly assigned to receive aspirin (n=6270) or placebo (n=6276) at 501 study sites. Median follow-up was 60 months. In the intention-to-treat analysis, the primary endpoint occurred in 269 (4·29%) patients in the aspirin group versus 281 (4·48%) patients in the placebo group (hazard ratio [HR] 0·96; 95% CI 0·81-1·13; p=0·6038). Gastrointestinal bleeding events (mostly mild) occurred in 61 (0·97%) patients in the aspirin group versus 29 (0·46%) in the placebo group (HR 2·11; 95% CI 1·36-3·28; p=0·0007). The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311 [20·89%] in the placebo group. The overall incidence of adverse events was similar in both treatment groups (n=5142 [82·01%] vs n=5129 [81·72%] in the placebo group). The overall incidence of treatment-related adverse events was low (n=1050 [16·75%] vs n=850 [13·54%] in the placebo group; p<0·0001). There were 321 documented deaths in the intention-to-treat population (n=160 [2·55%] vs n=161 [2·57%] of 6276 patients in the placebo group).
INTERPRETATION
The event rate was much lower than expected, which is probably reflective of contemporary risk management strategies, making the study more representative of a low-risk population. The role of aspirin in primary prevention among patients at moderate risk could therefore not be addressed. Nonetheless, the findings with respect to aspirin's effects are consistent with those observed in the previously published low-risk primary prevention studies.
FUNDING
Bayer.",2018,The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311,"['patients at moderate risk', 'Between July 5, 2007, and Nov 15, 2016, 12\u2008546 patients', 'seven countries', 'Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors', 'patients at high risk of gastrointestinal bleeding or other bleeding, or diabetes', 'patients with a moderate estimated risk of a first cardiovascular event', 'patients at moderate risk of cardiovascular disease (ARRIVE']","['placebo tablets', 'computer-generated randomisation code to receive enteric-coated aspirin tablets', 'aspirin', 'placebo']","['overall incidence of treatment-related adverse events', 'haemorrhagic events and incidence of other adverse events', 'Gastrointestinal bleeding events', 'composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischaemic attack', 'risk of initial vascular events', 'overall incidence rate of serious adverse events', 'efficacy and safety', 'overall incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332166', 'cui_str': 'Moderate risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",12546.0,0.699512,The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311,"[{'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Gaziano', 'Affiliation': ""Brigham and Women's Hospital, Department of Medicine, Division of Aging, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; VA Boston Healthcare System, Boston, MA, USA. Electronic address: jmgaziano@partners.org.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Brotons', 'Affiliation': 'Sardenya Primary Health Care Center, EAP Sardenya-Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Coppolecchia', 'Affiliation': 'Bayer HealthCare LLC, Whippany, NJ, USA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cricelli', 'Affiliation': 'Società Italiana di Medicina Generale, Florence, Italy.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Darius', 'Affiliation': 'Department of Cardiology, Angiology, Nephrology and Intensive Care Medicine, Vivantes Neukoelln Medical Center, Berlin, Germany.'}, {'ForeName': 'Philip B', 'Initials': 'PB', 'LastName': 'Gorelick', 'Affiliation': 'Department of Translational Science & Molecular Medicine, Michigan State University College of Human Medicine, Grand Rapids, MI, USA; Vascular Neurology Program, Mercy Health Hauenstein Neurosciences, Grand Rapids, Michigan Grand Rapids, MI, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Howard', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Pearson', 'Affiliation': 'Department of Epidemiology and Medicine, University of Florida Health Science Center, Gainsville, FL, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Luis Miguel', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': 'Internal Medicine, Complutense University, Head of the Hypertension Unit, 12 de Octubre Hospital, Madrid, Spain.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Tendera', 'Affiliation': 'Department of Cardiology and Structural Heart Disease, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Tognoni', 'Affiliation': 'IRCCS - Istituto di Ricerche Farmacologiche ""Mario Negri"", Department of Cardiovascular Research, IRCSS, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)31924-X']
1640,30100838,Intraperitoneal dexmedetomidine as an adjuvant to bupivacaine for postoperative pain management in children undergoing laparoscopic appendectomy: A prospective randomized trial.,"Background and Aims
Intraperitoneal local anesthetic is an effective analgesic approach in laparoscopic appendectomy in adults. The aim of the study was to compare the postoperative pain when intraperitoneal bupivacaine is administered alone versus the addition of dexmedetomidine to it in children undergoing a laparoscopic appendectomy.
Methods
In this prospective randomized trial, 52 children were randomly allocated to Group B who received intraperitoneal bupivacaine 0.25% (2 mg/kg) or Group BD who received intraperitoneal bupivacaine 0.25% (2 mg/kg) plus dexmedetomidine (1 mcg/kg) for postoperative analgesia in children undergoing laparoscopic appendectomy. Postoperative pethidine consumption at day 1 was recorded and considered the primary outcome of the study. Patients were evaluated for pain scores at 0, 2, 4, 6, 12, and 24 h, time to first request of pethidine, sedation scores at 0, 2, 4, and 6 h, length of hospital stay, and parents' satisfaction. Chi-square, Fisher's exact, Student's t -test, and Mann-Whitney U-tests were used for analysis.
Results
Postoperative visual analog scale scores were lower in Group BD at 2, 4, and 6 h (mean = 3, 3, 3, respectively) compared with Group B (mean = 4, 5, 4, respectively) ( P < 0.05). Patients in Group BD had more sedation scores at 0, 2, and 4 h ( P < 0.05), longer time to first rescue analgesia ( P = 0.03), lesser rescue analgesic consumption ( P = 0.02), shorter length of hospital stay ( P = 0.02), and higher parents' satisfaction ( P = 0.01).
Conclusion
Adding dexmedetomidine to intraperitoneal bupivacaine provides adequate postoperative analgesia in children undergoing laparoscopic appendectomy.",2018,"Patients in Group BD had more sedation scores at 0, 2, and 4 h ( P < 0.05), longer time to first rescue analgesia ( P = 0.03), lesser rescue analgesic consumption ( P = 0.02), shorter length of hospital stay ( P = 0.02), and higher parents' satisfaction ( P = 0.01).
","['children undergoing a laparoscopic appendectomy', 'children undergoing laparoscopic appendectomy', 'laparoscopic appendectomy in adults', '52 children']","['bupivacaine', 'intraperitoneal bupivacaine', 'Intraperitoneal dexmedetomidine', 'dexmedetomidine', 'postoperative analgesia']","['postoperative pain', 'sedation scores', 'shorter length of hospital stay', 'rescue analgesic consumption', 'pain scores', ""parents' satisfaction"", 'longer time to first rescue analgesia', 'Postoperative visual analog scale scores', 'Postoperative pethidine consumption', ""time to first request of pethidine, sedation scores at 0, 2, 4, and 6 h, length of hospital stay, and parents' satisfaction""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",52.0,0.204853,"Patients in Group BD had more sedation scores at 0, 2, and 4 h ( P < 0.05), longer time to first rescue analgesia ( P = 0.03), lesser rescue analgesic consumption ( P = 0.02), shorter length of hospital stay ( P = 0.02), and higher parents' satisfaction ( P = 0.01).
","[{'ForeName': 'Ali Mohamed', 'Initials': 'AM', 'LastName': 'Elnabtity', 'Affiliation': 'Lecturer of Anesthesia and Intensive Care, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ibrahim', 'Affiliation': 'Associate Professor of Anesthesia and Intensive Care, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_760_17']
1641,30100844,Preoperative ketamine nebulization attenuates the incidence and severity of postoperative sore throat: A randomized controlled clinical trial.,"Background
Endotracheal intubation is the prominent cause of airway mucosal injury which results in postoperative sore throat (POST), with an incidence of 21%-65%. Although this complication is minor, if left unresolved, it produces significant agony and annoyance to the patient. This study was conducted to evaluate the efficacy of nebulized ketamine in decreasing POST.
Materials and Methods
After written informed consent, 96 patients of the American Society of Anesthesiologists physical status (PS) 1-2 between 18 and 60 years, of either sex undergoing general anesthesia (GA) with tracheal intubation were enrolled in this prospective, randomized, placebo-control, and double-blind controlled trial. Patients were randomized into two groups; Group 1 received ketamine 50 mg (1.0 ml) with 4.0 ml of saline nebulization, while Group 2 received saline nebulization 5.0 ml for 15 min. GA was administered 15 min after completing nebulization. On reaching postanesthesia care unit, POST monitoring was done at 0, 2, 4, 6, 12, and 24 h after extubation. POST was graded on a four-point scale (0-3).
Results
The overall incidence of POST in this study was 25%: POST was experienced by 7 patients (14.6%) in ketamine and 17 patients (35.4%) in saline group (Fisher's exact P = 0.018). There was statistically significant reduction in the incidence of POST in ketamine group when compared to saline, at 2, 4, 6,12, and 24 h postoperatively ( P < 0.05*). Severity of sore throat was also higher in saline group when compared to ketamine at 4 h ( P = 0.030*) and 6 h ( P = 0.016*) postextubation.
Conclusion
Preoperative ketamine nebulization effectively reduced the incidence and severity of POST, with no adverse effects.",2018,Severity of sore throat was also higher in saline group when compared to ketamine at 4 h ( P = 0.030,"['96 patients of the American Society of Anesthesiologists physical status (PS) 1-2 between 18 and 60 years, of either sex undergoing general anesthesia (GA) with tracheal intubation']","['GA', 'placebo-control', '\n\n\nEndotracheal intubation', 'ketamine', 'nebulized ketamine', 'ketamine 50 mg (1.0 ml) with 4.0 ml of saline nebulization, while Group 2 received saline nebulization 5.0 ml for 15 min', 'Preoperative ketamine nebulization']","['overall incidence of POST', 'incidence and severity of postoperative sore throat', 'incidence and severity of POST', 'Severity of sore throat', 'incidence of POST']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}]",,0.42185,Severity of sore throat was also higher in saline group when compared to ketamine at 4 h ( P = 0.030,"[{'ForeName': 'Derlin', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Department of Anesthesiology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, India.'}, {'ForeName': 'Revathy', 'Initials': 'R', 'LastName': 'Bejoy', 'Affiliation': 'Department of Anesthesiology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, India.'}, {'ForeName': 'Nimeeliya', 'Initials': 'N', 'LastName': 'Zabrin', 'Affiliation': 'Department of Anesthesiology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, India.'}, {'ForeName': 'Suhura', 'Initials': 'S', 'LastName': 'Beevi', 'Affiliation': 'Department of Anesthesiology, Azeezia Institute of Medical Sciences and Research, Kollam, Kerala, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_47_18']
1642,30100843,"Comparison of Macintosh, McCoy, and Glidescope video laryngoscope for intubation in morbidly obese patients: Randomized controlled trial.","Objectives
The aim of the study was to compare time to intubation and glottic visualization between Macintosh, McCoy, and Glidescope video laryngoscope (GVL) in morbidly obese patients.
Methodology
Forty-five American Society of Anesthesiologists I-III morbidly obese patients were randomized into three groups of 15 each and time to intubation, Cormack-Lehane grading, and Intubation Difficulty Score (IDS) were compared.
Results
GVL took more time to intubate (TTI) compared to Macintosh and McCoy laryngoscope ( P = 0.0001). Overall IDS were similar between the groups.
Conclusion
To conclude, GVL takes longer TTI with no added advantage in IDS and hemodynamic response to intubation in morbidly obese patients. McCoy is only as effective as Macintosh and hence Macintosh laryngoscope should be laryngoscope of choice due to its widespread availability and familiarity.",2018,"Results
GVL took more time to intubate (TTI) compared to Macintosh and McCoy laryngoscope ( P = 0.0001).","['Methodology\n\n\nForty-five American Society of Anesthesiologists', 'I-III morbidly obese patients', 'morbidly obese patients']","['Macintosh, McCoy, and Glidescope video laryngoscope (GVL', 'Macintosh, McCoy, and Glidescope video laryngoscope', 'McCoy']","['time to intubate (TTI', 'Overall IDS']","[{'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0761034', 'cui_str': 'tsetse thrombin inhibitor'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",45.0,0.105016,"Results
GVL took more time to intubate (TTI) compared to Macintosh and McCoy laryngoscope ( P = 0.0001).","[{'ForeName': 'Keerthi P', 'Initials': 'KP', 'LastName': 'Nandakumar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Amar P', 'Initials': 'AP', 'LastName': 'Bhalla', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra Kumar', 'Initials': 'RK', 'LastName': 'Pandey', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Dalim Kumar', 'Initials': 'DK', 'LastName': 'Baidya', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Lokesh', 'Initials': 'L', 'LastName': 'Kashyap', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_754_17']
1643,31350938,"The beneficial effect of traditional Japanese herbal (Kampo) medicine, Hochu-ekki-to (Bu-Zhong-Yi-Qi-Tang), for patients with chronic wounds refractory to conventional therapies: A prospective, randomized trial.","Hochu-ekki-to (HET) is a traditional Japanese herbal (Kampo) medicine for the treatment of severe weakness, loss of appetite, and indigestion in elderly patients and for the prevention of opportunistic infections. The impact of HET on patients with chronic wounds refractory to conventional therapies was investigated in a prospective, randomized trial, including 18 patients divided into medication (7.5 g oral HET per day, n = 9) and control (n = 9) groups. Wound healing during the 12-week study period was scored based on depth, exudate, size, inflammation/infection, granulation tissue, necrotic tissue, and pocket size. At 12 weeks, wound healing progressed in all nine patients in the medication group, whereas wound healing progressed in only three patients in the control group (significant difference, p < 0.01; relative risk: 3.00). In the medication group, the total score decreased significantly at 8 weeks and later. To the best of our knowledge, this study was the first to show that HET promoted the healing of chronic wounds resistant to conventional treatments. HET may be a choice as an adjunctive therapy for chronic wounds, particularly for patients with malnutrition. This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000031620).",2019,"At 12 weeks, wound healing progressed in all nine patients in the medication group, whereas wound healing progressed in only three patients in the control group (significant difference, p < 0.01; relative risk: 3.00).","['patients with chronic wounds refractory to conventional therapies', '18 patients divided into medication (7.5\u2009g oral HET per day, n = 9) and control (n = 9) groups', 'patients with malnutrition']","['Japanese herbal (Kampo) medicine', 'traditional Japanese herbal (Kampo) medicine, Hochu-ekki-to (Bu-Zhong-Yi-Qi-Tang', 'HET', 'Hochu-ekki-to (HET']","['total score', 'depth, exudate, size, inflammation/infection, granulation tissue, necrotic tissue, and pocket size', 'Wound healing', 'wound healing progressed']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2240391', 'cui_str': 'Herbal medicine (product)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0911380', 'cui_str': 'hochu-ekki-to'}, {'cui': 'C0911379', 'cui_str': 'herbal drug HET'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0018180', 'cui_str': 'Granulation Tissue'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",,0.0255516,"At 12 weeks, wound healing progressed in all nine patients in the medication group, whereas wound healing progressed in only three patients in the control group (significant difference, p < 0.01; relative risk: 3.00).","[{'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Akita', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Namiki', 'Affiliation': 'Department of Japanese-Oriental (Kampo) Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Naoaki', 'Initials': 'N', 'LastName': 'Rikihisa', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Chiba Rosai Hospital, Chiba, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tokumoto', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Chiba Cancer Center Hospital, Chiba, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Tezuka', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Kubota', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Motone', 'Initials': 'M', 'LastName': 'Kuriyama', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Michimi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Japanese-Oriental (Kampo) Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Mitsukawa', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12753']
1644,31632654,Costs and consequences of the Family Nurse Partnership (FNP) programme in England: evidence from the Building Blocks trial.,"Background: The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners. The Building Blocks (BB) trial aimed to explore the effectiveness and cost-effectiveness of this programme. This paper reports the results of an economic evaluation of the Building Blocks randomised controlled trial (RCT) based on a cost-consequence approach. Methods : A large sample of 1618 families was followed-up at various intervals during pregnancy and for two years after birth. A cost-consequence approach was taken to appraise the full range of costs arising from the intervention including both health and social measures of cost alongside the consequences of the trial, specifically, the primary outcomes. Results : A large number of potential factors were identified that are likely to attract additional costs beyond the implementation costs of the intervention including both health and non-health outcomes. Conclusion : Given the extensive costs and only small beneficial consequences observed within the two year follow-up period, the cost-consequence model suggests that the FNP intervention is unlikely to be worth the substantial costs and policy makers may wish to consider other options for investment. Trial registration : ISRCTN23019866 (20/04/2009).",2019,The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners.,[],"['FNP intervention', 'Family Nurse Partnership (FNP) programme', 'Family Nurse Partnership (FNP']",['effectiveness and cost-effectiveness'],[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",1618.0,0.0621001,The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners.,"[{'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Corbacho', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ronaldson', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, CF14 4YS, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, CF14 4XN, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Population Health Trials, Cardiff University, Cardiff, CF14 4ER, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.20149.1']
1645,29996688,Fetus delivery time in extraperitoneal versus transperitoneal cesarean section: a randomized trial.,"Objective: We compared the extraperitoneal cesarean section to transperitoneal cesarean on fetal delivery time. Material and methods: This randomized study included 210 pregnant women undergoing cesarean section for elective reasons, repeat cesarean (< four), or dystocia. Patients who required an urgent cesarean section, who were at high risk for obstetric or maternal bleeding, who had a uterine or adnexal mass, or who requested tubal ligation were excluded from the study. The primary outcome of the study was the skin incision-to-delivery time. The sample size was set to detect of 1-minute difference in fetal delivery time between groups (two-tailed hypothesis, α = 0.05, β = 0.10). Secondary outcome measures were total operation time, intraoperative nausea, gag reflex, vomiting, pain and anxiety for those receiving regional anesthesia, postoperative pain, change in hemoglobin, postoperative analgesic requirements, nausea, vomiting and shoulder pain, urogenital distress, time until gas passage, and neonatal outcome. Results: No significant difference occurred between the two groups for skin incision-to- delivery time (extraperitoneal cesarean 3.9 minutes [2.1-7.3] versus transperitoneal cesarean 4.2 minutes [1.9-8.2], p = .065). Significant differences regarding intraoperative pain, total operation time, postoperative pain at the surgical site and shoulder pain, analgesic requirements, time until gas passage, and oral tolerability favored the extraperitoneal group. No significant differences between groups occurred regarding other seconder outcome parameters. Conclusions: There is no clinically significant difference between extraperitoneal cesarean section and transperitoneal cesarean on fetal delivery time. Extraperitoneal cesarean reduces postoperative pain, analgesic requirements, and improves oral tolerability.",2020,"No significant difference occurred between the two groups for skin incision-to- delivery time (extraperitoneal cesarean 3.9 minutes [2.1-7.3] versus transperitoneal cesarean 4.2 minutes [1.9-8.2], p = .065).","['Patients who required an urgent cesarean section, who were at high risk for obstetric or maternal bleeding, who had a uterine or adnexal mass, or who requested tubal ligation were excluded from the study', '210 pregnant women undergoing cesarean section for elective reasons, repeat cesarean (< four), or dystocia']","['extraperitoneal versus transperitoneal cesarean section', 'extraperitoneal cesarean section to transperitoneal cesarean', 'Extraperitoneal cesarean']","['postoperative pain, analgesic requirements', 'Fetus delivery time', 'intraoperative pain, total operation time, postoperative pain at the surgical site and shoulder pain, analgesic requirements, time until gas passage, and oral tolerability', 'fetal delivery time', 'skin incision-to- delivery time', 'skin incision-to-delivery time', 'extraperitoneal cesarean section and transperitoneal cesarean on fetal delivery time', 'total operation time, intraoperative nausea, gag reflex, vomiting, pain and anxiety for those receiving regional anesthesia, postoperative pain, change in hemoglobin, postoperative analgesic requirements, nausea, vomiting and shoulder pain, urogenital distress, time until gas passage, and neonatal outcome', 'oral tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0149614', 'cui_str': 'Adnexal mass'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0520483', 'cui_str': 'Tubal Ligation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0013418', 'cui_str': 'Dystocia'}]","[{'cui': 'C0442090', 'cui_str': 'Extraperitoneal (qualifier value)'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0195621', 'cui_str': 'Extraperitoneal cesarean section (procedure)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0195621', 'cui_str': 'Extraperitoneal cesarean section (procedure)'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",210.0,0.133251,"No significant difference occurred between the two groups for skin incision-to- delivery time (extraperitoneal cesarean 3.9 minutes [2.1-7.3] versus transperitoneal cesarean 4.2 minutes [1.9-8.2], p = .065).","[{'ForeName': 'Omer E', 'Initials': 'OE', 'LastName': 'Yapca', 'Affiliation': 'Department of Obstetrics and Gynecology, Atatürk University Faculty of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Yunus E', 'Initials': 'YE', 'LastName': 'Topdagi', 'Affiliation': 'Department of Obstetrics and Gynecology, Atatürk University Faculty of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ragip A', 'Initials': 'RA', 'LastName': 'Al', 'Affiliation': 'Department of Obstetrics and Gynecology, Atatürk University Faculty of Medicine, Erzurum, Turkey.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1499718']
1646,29985079,One-step versus two-step diagnostic testing for gestational diabetes: a randomized controlled trial.,"Objective: To evaluate the incidence of gestational diabetes mellitus (GDM) using the one-step as compared with the two-step approach. Study design: This was a parallel group nonblinded randomized trial conducted at Thomas Jefferson University Hospital (TJUH) in Philadelphia, Pennsylvania from June 2016 to December 2016. The primary outcome was GDM incidence in the one-step compared to the two-approach. Pregnant women without a history of pregestational diabetes were offered screening for GDM at gestational age 24-28 weeks. Obese women, defined as having a BMI ≥30 kg/m 2 , as well as those with a history of a pregnancy complicated by GDM, a history of a macrosomic baby (>4000 g), or with polycystic ovarian syndrome (PCOS), were offered early screening at their initial prenatal visit, and screening was repeated at 24-28 weeks if initially normal. Women were excluded if they had pre-existing diabetes or had a history of bariatric surgery. Women who were eligible were randomized in a 1:1 ratio to either the one-step or two-step approaches. A sample size of 142 women was planned per group. Women randomized to the one-step approach, after an overnight fast, were given a 2-h glucose tolerance test, which consisted of a 75-g glucose load. Blood glucose levels were measured fasting, at 1 h and 2 h after the glucose load. Diagnostic cutoffs for GDM diagnosis were one value of either fasting ≥92 mg/dL, 1 h ≥180 mg/dL, or 2 h ≥153 mg/dL, respectively. Women randomized to the two-step approach were given a nonfasting 50-g glucose load, and the blood glucose level was measured an hour after the glucose load. If that value was ≥135 mg/dL, the patient had a 3-h glucose tolerance test consisting of a 100-g glucose load. Diagnostic cutoffs for GDM diagnosis for this 3-h test were ≥2 abnormal values of fasting ≥95 mg/dL, 1 h ≥180 mg/dL, 2 h ≥155 mg/dL and 3 h ≥140 mg/dL, respectively. All analyses were done using an intention-to-treat approach, evaluating women according to the treatment group to which they were randomly allocated. Results: Two hundred eighty-four women agreed to take part in the study and underwent randomization from June 2015 to December 2015. Of them, 249 completed the screening and were followed up for the primary endpoint. Out of the 249 women who completed the screening, 123 were assigned to the one-step group and 126 to the two-step group. GDM occurred in 10 women (8.1%) in the one-step group, and 7 women (5.6%) in the two-step group ( p = .42). Preeclampsia, preterm birth (PTB), induction of labor, mode of delivery and incidence of gestational age (OASIS) were not significantly different. Perinatal outcomes were similar as well. Conclusions: Screening for GDM with one-step, compared with the two-step approach, resulted in a similar incidence of GDM.",2020,Pregnant women without a history of pregestational diabetes were offered screening for GDM at gestational age 24-28 weeks.,"['Women were excluded if they had pre-existing diabetes or had a history of bariatric surgery', 'Thomas Jefferson University Hospital (TJUH) in Philadelphia, Pennsylvania from June 2016 to December 2016', 'Pregnant women without a history of pregestational diabetes', '249 women who completed the screening, 123 were assigned to the one-step group and 126 to the two-step group', 'Obese women, defined as having a BMI ≥30\u2009kg/m 2 , as well as those with a history of a pregnancy complicated by GDM, a history of a macrosomic baby (>4000\u2009g), or with polycystic ovarian syndrome (PCOS), were offered early screening at their initial prenatal visit, and screening was repeated at 24-28 weeks if initially normal', '142 women was planned per group', 'gestational diabetes', 'Two hundred eighty-four women agreed to take part in the study and underwent randomization from June 2015 to December 2015']",[],"['Preeclampsia, preterm birth (PTB), induction of labor, mode of delivery and incidence of gestational age (OASIS', 'Blood glucose levels', 'GDM', 'blood glucose level', 'GDM incidence', 'incidence of gestational diabetes mellitus (GDM']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3266786', 'cui_str': 'History of bariatric surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1827362', 'cui_str': 'Prenatal initial visit (regime/therapy)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],"[{'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}]",284.0,0.0973567,Pregnant women without a history of pregestational diabetes were offered screening for GDM at gestational age 24-28 weeks.,"[{'ForeName': 'Adeeb', 'Initials': 'A', 'LastName': 'Khalifeh', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Einstein Medical Center, Philadelphia,PA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Eckler', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia,PA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Felder', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia,PA, USA.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia,PA, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Caissutti', 'Affiliation': 'Department of Experimental Clinical and Medical Science, DISM, Clinic of Obstetrics and Gynecology, University of Udine, Udine, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Berghella', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia,PA, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1498480']
1647,31073880,A School-Based Comparison of Positive Search Training to Enhance Adaptive Attention Regulation with a Cognitive-Behavioural Intervention for Reducing Anxiety Symptoms in Children.,"Many children experience anxiety but have limited access to empirically-supported interventions. School-based interventions using brief, computer-assisted training provide a viable way of reaching children. Recent evidence suggests that computer-delivered 'positive search training' (PST) reduces anxiety in children. This multi-informant, randomised controlled trial compared classroom-based, computer-delivered PST (N = 116) to a classroom-based, therapist-delivered cognitive-behavioural intervention (CBI) (N = 127) and a curriculum-as-usual control condition (CAU) (N = 60) in 7-11 year old children. Primary outcomes were child and parent report of child anxiety symptoms. Secondary outcomes were child and parent report of child depressive symptoms and child attention biases. Outcomes were assessed before and after the interventions, and six- and 12-months post-intervention. Teacher report of children's social-emotional functioning was assessed at pre- and post-intervention. As expected, compared to CAU, children receiving PST and the CBI reported greater anxiety reductions by post-intervention and six-month follow-up but, unexpectedly, not at 12-month follow-up. Partially consistent with hypotheses, compared to CAU, parents reported greater anxiety reductions in children receiving PST, but not the CBI, at 12-month follow-up. Contrary to expectation, there was a pre- to post-intervention increase in threat attention bias in PST compared to the other conditions, with no significant differences at follow-up. In support of hypotheses, teachers reported higher post-intervention social-emotional functioning in Year 5 students receiving the CBI but, unexpectedly, lower post-intervention functioning in students receiving PST. There were no effects on depressive symptoms. Further research is needed on strategies to maintain long-term benefits and determine preventative versus early intervention effects.",2019,"In support of hypotheses, teachers reported higher post-intervention social-emotional functioning in Year 5 students receiving the CBI but, unexpectedly, lower post-intervention functioning in students receiving PST.","['children', 'Children']","['classroom-based, computer-delivered PST (N\u2009=\u2009116) to a classroom-based, therapist-delivered cognitive-behavioural intervention (CBI', 'curriculum-as-usual control condition (CAU', ""computer-delivered 'positive search training' (PST"", 'Cognitive-Behavioural Intervention']","['child and parent report of child depressive symptoms and child attention biases', 'child and parent report of child anxiety symptoms', 'depressive symptoms', 'anxiety reductions', 'threat attention bias', ""children's social-emotional functioning""]","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0259095', 'cui_str': 'C(2)BI'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",,0.109875,"In support of hypotheses, teachers reported higher post-intervention social-emotional functioning in Year 5 students receiving the CBI but, unexpectedly, lower post-intervention functioning in students receiving PST.","[{'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Waters', 'Affiliation': 'School of Applied Psychology, Griffith University, Queensland, 4122, Australia. a.waters@griffith.edu.au.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Candy', 'Affiliation': 'Scandy Statistical Modelling Pty Ltd, Blackmans Bay, Australia.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Zimmer-Gembeck', 'Affiliation': 'School of Applied Psychology, Griffith University, Queensland, 4122, Australia.'}, {'ForeName': 'Trisha A', 'Initials': 'TA', 'LastName': 'Groth', 'Affiliation': 'School of Applied Psychology, Griffith University, Queensland, 4122, Australia.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Bradley', 'Affiliation': 'Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mogg', 'Affiliation': 'Psychology, University of Southampton, Southampton, UK.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00551-4']
1648,29986613,Continuous oxytocin versus intermittent oxytocin for induction of labor: a randomized study.,"Objective: To assess whether intermittent usage of oxytocin infusion increases the duration of the active phase of labor and reduces maternal and neonatal complications or not. Materials and Methods: A prospective randomized controlled study was conducted of 200 consenting women with singleton pregnancy in the vertex position undergoing labor induction or augmentation at the Zeynep Kamil Maternity and Children's Training and Research Hospital. Participants with cervical dilation of 3 cm were randomized to either continued or intermittent oxytocin infusion when cervical dilation reached 5 cm. The primary outcome measures were the duration of the active phase of labor, defined as the period of labor from 5 cm of cervical dilation to vaginal delivery. Secondary outcomes were the duration of oxytocin infusion, mode of delivery, hyperstimulation, abnormalities in fetal heart rate, perineal tears, and neonatal outcomes. Results: The median duration of the active phase for the women with a vaginal delivery was longer in the intermittent oxytocin group than the continued oxytocin group, but it was not statistically significant (median, 6.91 vs. 7.58 h, p = .37). There was a significant difference in the duration of oxytocin infusion (median, 12.38 h in the intermittent group vs. 15.79 h in the continued group, p = .005). The incidence of uterine hyperstimulation was significantly greater in the continued group (21.1%) than the intermittent oxytocin group (3.8%) ( p =.001). Conclusions: Intermittent usage of oxytocin infusion seems to make labor less complicated without lengthening duration of labor.",2020,"The incidence of uterine hyperstimulation was significantly greater in the continued group (21.1%) than the intermittent oxytocin group (3.8%) (p=.001).
","[""200 consenting women with singleton pregnancy in the vertex position undergoing labor induction or augmentation at the Zeynep Kamil Maternity and Children's Training and Research Hospital"", 'labor', 'Participants with cervical dilation of 3\u2009cm']","['intermittent oxytocin infusion', 'Continuous oxytocin', 'oxytocin']","['duration of the active phase of labor, defined as the period of labor from 5\u2009cm of cervical dilation to vaginal delivery', 'incidence of uterine hyperstimulation', 'duration of oxytocin infusion, mode of delivery, hyperstimulation, abnormalities in fetal heart rate, perineal tears, and neonatal outcomes', 'duration of the active phase of labor and reduces maternal and neonatal complications or not', 'median duration of the active phase for the women with a vaginal delivery', 'duration of oxytocin infusion']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0035168'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0269842', 'cui_str': 'Hypertonic uterine dysfunction (disorder)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0018811', 'cui_str': 'Heart Rate, Fetal'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",200.0,0.0918376,"The incidence of uterine hyperstimulation was significantly greater in the continued group (21.1%) than the intermittent oxytocin group (3.8%) (p=.001).
","[{'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Bostancı', 'Affiliation': ""Department of Obstetrics and Gynecology, Zeynep Kamil Maternity and Children's Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Cetin', 'Initials': 'C', 'LastName': 'Kilicci', 'Affiliation': ""Department of Obstetrics and Gynecology, Zeynep Kamil Maternity and Children's Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Enis', 'Initials': 'E', 'LastName': 'Ozkaya', 'Affiliation': ""Department of Obstetrics and Gynecology, Zeynep Kamil Maternity and Children's Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Cigdem', 'Initials': 'C', 'LastName': 'Abide Yayla', 'Affiliation': ""Department of Obstetrics and Gynecology, Zeynep Kamil Maternity and Children's Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Eroglu', 'Affiliation': ""Department of Obstetrics and Gynecology, Zeynep Kamil Maternity and Children's Training and Research Hospital, Istanbul, Turkey.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1499092']
1649,29970319,The effect of acute oral phosphatidic acid ingestion on myofibrillar protein synthesis and intracellular signaling in older males.,"BACKGROUND
Age-related muscle loss (sarcopenia) may be driven by a diminished myofibrillar protein synthesis (MyoPS) response to anabolic stimuli (i.e. exercise and nutrition). Oral phosphatidic acid (PA) ingestion has been reported to stimulate resting muscle protein synthesis in rodents, and enhance resistance training-induced muscle remodelling in young humans.
PURPOSE
This study examined the effects of acute oral PA ingestion on resting and exercise-induced MyoPS rates in older individuals.
METHODS
Sixteen older males performed a bout of unilateral leg resistance exercise followed by oral ingestion of 750 mg of soy-derived PA or a rice-flour placebo (PL) over 60 min post-exercise. A primed-continuous infusion of l-[ring- 13 C 6 ]-phenylalanine with serial muscle biopsies was used to determine MyoPS at rest and between 0-150 and 150-300 min post-exercise.
RESULTS
Plasma [PA] concentrations were elevated above basal values from 180 to 300 min post-exercise in PA only (P = 0.02). Exercise increased MyoPS rates above basal values between 150 and 300 min post-exercise in PL (P = 0.001), but not PA (P = 0.83). Phosphorylation of p70S6K, rpS6, 4E-BP1 and Akt was elevated above basal levels in the exercised leg over 150-300 min post-exercise for PL only (P = 0.018, 0.007, 0.011 and 0.002, respectively), and were significantly greater than PA (P < 0.01 for all proteins). The effects of oral PA ingestion on proteolytic signaling markers were equivocal.
CONCLUSIONS
Acute oral phosphatidic acid ingestion appears to interfere with resistance exercise-induced intramuscular anabolic signaling and MyoPS in older males and, therefore, may not be a viable treatment to counteract sarcopenia. Clinicaltials.gov registration no: NCT03446924.",2019,"Phosphorylation of p70S6K, rpS6, 4E-BP1 and Akt was elevated above basal levels in the exercised leg over 150-300 min post-exercise for PL only (P = 0.018, 0.007, 0.011 and 0.002, respectively), and were significantly greater than PA (P ","['young humans', 'older males', 'older individuals', 'Sixteen older males']","['Oral phosphatidic acid (PA) ingestion', 'Clinicaltials.gov registration', 'unilateral leg resistance exercise followed by oral ingestion of 750\xa0mg of soy-derived PA or a rice-flour placebo (PL', 'acute oral PA ingestion', 'oral PA ingestion', 'acute oral phosphatidic acid ingestion']","['myofibrillar protein synthesis and intracellular signaling', 'Plasma [PA] concentrations', 'Phosphorylation of p70S6K, rpS6, 4E-BP1 and Akt was elevated above basal levels', 'MyoPS rates', 'MyoPS rates above basal values']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0031612', 'cui_str': 'Phosphatidic Acids'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C1136240', 'cui_str': 'Ribosomal Protein S6 Kinases, 70-kDa'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",16.0,0.0489869,"Phosphorylation of p70S6K, rpS6, 4E-BP1 and Akt was elevated above basal levels in the exercised leg over 150-300 min post-exercise for PL only (P = 0.018, 0.007, 0.011 and 0.002, respectively), and were significantly greater than PA (P ","[{'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Smeuninx', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, West Midlands B15 2TT, UK; MRC-ARUK Centre for Musculoskeletal Ageing Research, University of Birmingham, Edgbaston, West Midlands B15 2TT, UK.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, West Midlands B15 2TT, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKendry', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, West Midlands B15 2TT, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Limb', 'Affiliation': 'Clinical, Metabolic and Molecular Physiology Group, University of Nottingham, Royal Derby Hospital, Nottingham DE22 3DT, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, University of Birmingham, Edgbaston, West Midlands B15 2TT, UK; Clinical, Metabolic and Molecular Physiology Group, University of Nottingham, Royal Derby Hospital, Nottingham DE22 3DT, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, University of Birmingham, Edgbaston, West Midlands B15 2TT, UK; Clinical, Metabolic and Molecular Physiology Group, University of Nottingham, Royal Derby Hospital, Nottingham DE22 3DT, UK.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Breen', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, West Midlands B15 2TT, UK; MRC-ARUK Centre for Musculoskeletal Ageing Research, University of Birmingham, Edgbaston, West Midlands B15 2TT, UK. Electronic address: L.breen@bham.ac.uk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.06.963']
1650,29985724,Effects of kinesio taping on neuromuscular performance and pain of individuals affected by patellofemoral pain: A randomized controlled trial.,"Patellofemoral pain (PFP) is one of the most frequent musculoskeletal dysfunctions in the knee and its treatment is controversial. This study analyzed the effects of Kinesio Taping (KT) immediately and 72 hours after its application on the electromyographic (EMG) activity of the vastus medialis oblique (VMO) muscle, on the isokinetic performance of the quadriceps femoris and on the pain of subjects with PFP. Fifty-four participants were divided into three groups and performed one of the following protocols: (1) control group (CG)-remained at rest; (2) KT tension group (TG)-KT application with tension in the VMO region; and (3) KT without tension group (WTG)-KT application without tension in the same region. VMO and vastus lateralis (VL) EMG activity (RMS and onset), isokinetic performance and pain intensity were evaluated at three moments: before KT application, immediately after and 72 hours after. A mixed model ANOVA was used for statistical analysis with a significance level of 5% ( p ≤ 0.05). No differences between the evaluated groups were found in relation to EMG variables and isokinetic performance. A reduction in pain intensity was found in the WTG in comparison to CG, after 72 hours. KT does not alter EMG parameters nor the isokinetic performance of subjects with PFP. However, we noticed reduced pain in the group submitted to the technique without tension 72 hours after its application.",2020,"A reduction in pain intensity was found in the WTG in comparison to CG, after 72 hours.","['individuals affected by patellofemoral pain', 'subjects with PFP', 'Fifty-four participants']","['kinesio taping', 'Kinesio Taping (KT', 'control group (CG)-remained at rest; (2) KT tension group (TG)-KT application with tension in the VMO region; and (3) KT without tension group (WTG)-KT application without tension in the same region']","['neuromuscular performance and pain', 'Patellofemoral pain (PFP', 'pain', 'relation to EMG variables and isokinetic performance', 'electromyographic (EMG) activity of the vastus medialis oblique (VMO) muscle', 'pain intensity', 'VMO and vastus lateralis (VL) EMG activity (RMS and onset), isokinetic performance and pain intensity', 'isokinetic performance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",54.0,0.0187951,"A reduction in pain intensity was found in the WTG in comparison to CG, after 72 hours.","[{'ForeName': 'Samara Alencar', 'Initials': 'SA', 'LastName': 'Melo', 'Affiliation': 'Department of Physiotherapy, Federal University of Rio Grande do Norte (UFRN) , Natal, Brazil.'}, {'ForeName': 'Liane de Brito', 'Initials': 'LB', 'LastName': 'Macedo', 'Affiliation': 'Department of Physiotherapy, Federal University of Rio Grande do Norte (UFRN) , Natal, Brazil.'}, {'ForeName': 'Daniel Tezoni', 'Initials': 'DT', 'LastName': 'Borges', 'Affiliation': 'Department of Physiotherapy, Federal University of Rio Grande do Norte (UFRN) , Natal, Brazil.'}, {'ForeName': 'Jamilson Simões', 'Initials': 'JS', 'LastName': 'Brasileiro', 'Affiliation': 'Department of Physiotherapy, Federal University of Rio Grande do Norte (UFRN) , Natal, Brazil.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1492657']
1651,29950801,Laser Angiography to Assess the Vaginal Cuff During Robotic Hysterectomy.,"Background and Objectives
Vaginal cuff dehiscence may be a vascular-mediated event, and reports show a higher incidence after robot-assisted total laparoscopic hysterectomy (RATLH), when compared with other surgical routes. This study was conducted to determine the feasibility of using laser angiography to assess vaginal cuff perfusion during RATLH.
Methods
This was a pilot feasibility trial incorporating 20 women who underwent RATLH for benign disease. Colpotomy was made with ultrasonic or monopolar instruments, whereas barbed or nonbarbed suture was used for cuff closure. Time of instrument activation during colpotomy was recorded. Images were captured of vaginal cuff perfusion before and after cuff closure. Reviewers evaluated these images and determined areas of adequate cuff perfusion.
Results
Indocyanine green (ICG) was visible at the vaginal cuff in all participants. Optimal dosage was determined to be 7.5 mg of ICG per intravenous dose. Mean time to appearance for ICG was 18.4 ± 7.3 s (mean ± SD) before closure and 19.0 ± 8.7 s after closure. No significant difference ( P = .19) was noted in judged perfusion in open cuffs after colpotomy with a monopolar (48.9 ± 26.0%; mean ± SD) or ultrasonic (40.2 ± 14.1%) device. No difference was seen after cuff closure ( P = .36) when a monopolar (70.9 ± 21.1%) or ultrasonic (70.5 ± 20.5%) device was used. The use of barbed (74.1 ± 20.1%) or nonbarbed (66.4 ± 20.9%) sutures did not significantly affect estimated closed cuff perfusion ( P = .19). Decreased cuff perfusion was observed with longer instrument activation times in open cuffs ( R 2 = 0.3175).
Conclusion
Laser angiography during RATLH allows visualization of vascular perfusion of the vaginal cuff. The technology remains limited by the lack of quantifiable fluorescence and knowledge of clinically significant levels of fluorescence.",2018,No significant difference ( P = .19) was noted in judged perfusion in open cuffs after colpotomy with a monopolar (48.9 ± 26.0%; mean ± SD) or ultrasonic (40.2 ± 14.1%) device.,['20 women who underwent RATLH for benign disease'],"['Laser Angiography', 'robot-assisted total laparoscopic hysterectomy (RATLH', 'Laser angiography during RATLH', 'laser angiography', 'ICG', 'Indocyanine green (ICG']","['closed cuff perfusion', 'vaginal cuff perfusion', 'Decreased cuff perfusion', 'Vaginal Cuff', 'Mean time to appearance for ICG']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]",20.0,0.0282924,No significant difference ( P = .19) was noted in judged perfusion in open cuffs after colpotomy with a monopolar (48.9 ± 26.0%; mean ± SD) or ultrasonic (40.2 ± 14.1%) device.,"[{'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Beran', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Shockley', 'Affiliation': 'Department of Gynecology and Obstetrics, Gynecologic Specialties, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Pamela Frazzini', 'Initials': 'PF', 'LastName': 'Padilla', 'Affiliation': 'Department of Gynecology, Section of Minimally Invasive Gynecologic Surgery, Cleveland Clinic Florida, Weston, Florida, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Farag', 'Affiliation': 'Department of Gynecology, Section of Minimally Invasive Gynecologic Surgery, Cleveland Clinic Florida, Weston, Florida, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Escobar', 'Affiliation': 'Department of Obstetrics and Gynecology, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Zimberg', 'Affiliation': 'Department of Gynecology, Section of Minimally Invasive Gynecologic Surgery, Cleveland Clinic Florida, Weston, Florida, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Sprague', 'Affiliation': 'Department of Gynecology, Section of Minimally Invasive Gynecologic Surgery, Cleveland Clinic Florida, Weston, Florida, USA.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2018.00001']
1652,31585010,"Methodological concerns on 'Assessment of ovarian reserve after cystectomy versus ""one-step"" laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial'.",,2019,,['ovarian endometrioma'],"['cystectomy versus ""one-step"" laser vaporization']",[],"[{'cui': 'C1536148', 'cui_str': 'Chocolate cyst of ovary (disorder)'}]","[{'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}]",[],,0.0470425,,"[{'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Leone Roberti Maggiore', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ferrero', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez140']
1653,31585011,"Reply: Methodological concerns on `Assessment of ovarian reserve after cystectomy versus ""one-step"" laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial'.",,2019,,['ovarian endometrioma'],"['cystectomy versus ""one-step"" laser vaporization']",[],"[{'cui': 'C1536148', 'cui_str': 'Chocolate cyst of ovary (disorder)'}]","[{'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}]",[],,0.0452657,,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Candiani', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ottolina', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Gynaecological Surgery and Endometriosis Departmental Unit, San Raffaele Scientific Institute, Milan, Italy.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez141']
1654,30059193,"Relative Bioavailability and Food Effect Evaluation for 2 Tablet Formulations of Asciminib in a 2-Arm, Crossover, Randomized, Open-Label Study in Healthy Volunteers.","Asciminib (ABL001) is an orally administered allosteric inhibitor of the BCR-ABL tyrosine kinase. The current study evaluated the relative bioavailability of its 2 tablet variants, AAA and NXA, compared with the capsule CSF and assessed the impact of food in healthy participants in a 2-arm, randomized, open-label, 4-way crossover design. The primary pharmacokinetic parameters analyzed were area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUC last ), AUC from time 0 to infinity (AUC inf ), and peak concentration (C max ). Forty-five healthy volunteers were enrolled, 22 in the AAA arm and 23 in the NXA arm. Under fasting conditions, the AUC inf , AUC last , and C max of the AAA tablet were similar to those of the capsule, but slightly higher (∼20%) for NXA and decreased with a high-fat meal (∼65%) and a low-fat meal (∼30%) for both tablet formulations. Overall, 20 participants (9 in the AAA arm; 11 in the NXA arm) experienced at least 1 adverse event, the most common in both arms being headache. The study showed that under fasting conditions, tablet AAA had bioavailability similar to that in the capsule CSF. The bioavailability of both tablet formulations decreased with food, with a more pronounced effect observed with a high-fat meal.",2019,"Under fasting conditions, the AUC inf , AUC last , and C max of the AAA tablet were similar to those of the capsule, but slightly higher (∼20%) for NXA and decreased with a high-fat meal (∼65%) and a low-fat meal (∼30%) for both tablet formulations.","['Forty-five healthy volunteers were enrolled, 22 in the AAA arm and 23 in the NXA arm', 'Healthy Volunteers', 'healthy participants']",[],"['Under fasting conditions, the AUC inf , AUC last , and C max of the AAA tablet', 'area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUC last ), AUC from time 0 to infinity (AUC inf ), and peak concentration (C max ', 'bioavailability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",[],"[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",45.0,0.0395268,"Under fasting conditions, the AUC inf , AUC last , and C max of the AAA tablet were similar to those of the capsule, but slightly higher (∼20%) for NXA and decreased with a high-fat meal (∼65%) and a low-fat meal (∼30%) for both tablet formulations.","[{'ForeName': 'Hans D', 'Initials': 'HD', 'LastName': 'Menssen', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Quinlan', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Charisse', 'Initials': 'C', 'LastName': 'Kemp', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Xianbin', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.602']
1655,29999537,How does meaning in life predict proactive coping? The self-regulatory mechanism on emotion and cognition.,"OBJECTIVE
This study examined the effectiveness of a photographic intervention method on meaning in life (MIL) and further investigated the self-regulatory mechanism responsible for the effect of MIL in the promotion of proactive coping.
METHOD
Participants were 145 Chinese adults (M age = 27.82; 71.3% female), who were randomly assigned into one of three conditions: An intervention (taking photos and writing expressively), a taking-photos-only control, or an assessment-only control. MIL, positive affect, future temporal focus, and proactive coping were measured before and after the intervention, with follow-up assessments conducted 1 week and 1 month later. Additionally, daily assessments were conducted during the intervention week.
RESULTS
MIL improved daily in the intervention condition, an effect that was also found post-intervention and at follow-up. Significant increases in positive affect, future temporal focus, and proactive coping were also observed after the intervention. Hierarchical linear modeling demonstrated that daily MIL positively predicted daily future temporal focus and positive affect. Furthermore, longitudinal mediation analysis confirmed that future temporal focus and positive affect mediated the relationship between MIL and proactive coping.
CONCLUSIONS
MIL's self-regulatory mechanism is reflected in both cognitive (future temporal focus) and emotional (positive affect) dimensions, which promotes proactive coping with future stressors.",2019,"RESULTS
MIL improved daily in the intervention condition, an effect that was also found post-intervention and at follow-up.",['Participants were 145 Chinese adults (M age \xa0=\xa027.82; 71.3% female'],"['photographic intervention', 'intervention (taking photos and writing expressively), a taking-photos-only control, or an assessment-only control']","['positive affect, future temporal focus, and proactive coping', 'MIL, positive affect, future temporal focus, and proactive coping', 'meaning in life (MIL']","[{'cui': 'C0660279', 'cui_str': '5-Heptenoic acid, 7-(3-(((4-iodophenyl)sulfonyl)amino)bicyclo(2.2.1)hept-2-yl)-, (1alpha,2alpha(Z),3beta,4alpha)-'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0067136', 'cui_str': 'N(1)-methyl-2-lysergic acid diethylamide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",145.0,0.0208959,"RESULTS
MIL improved daily in the intervention condition, an effect that was also found post-intervention and at follow-up.","[{'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Miao', 'Affiliation': 'School of Sociology, China University of Political Science and Law.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Gan', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health.'}]",Journal of personality,['10.1111/jopy.12416']
1656,30037647,"Continuous low-dose antibiotic prophylaxis for adults with repeated urinary tract infections (AnTIC): a randomised, open-label trial.","BACKGROUND
Repeated symptomatic urinary tract infections (UTIs) affect 25% of people who use clean intermittent self-catheterisation (CISC) to empty their bladder. We aimed to determine the benefits, harms, and cost-effectiveness of continuous low-dose antibiotic prophylaxis for prevention of recurrent UTIs in adult users of CISC.
METHODS
In this randomised, open-label, superiority trial, we enrolled participants from 51 UK National Health Service organisations. These participants were community-dwelling (as opposed to hospital inpatient) users of CISC with recurrent UTIs. We randomly allocated participants (1:1) to receive either antibiotic prophylaxis once daily (prophylaxis group) or no prophylaxis (control group) for 12 months by use of an internet-based system with permuted blocks of variable length. Trial and laboratory staff who assessed outcomes were masked to allocation but participants were aware of their treatment group. The primary outcome was the incidence of symptomatic, antibiotic-treated UTIs over 12 months. Participants who completed at least 6 months of follow-up were assumed to provide a reliable estimate of UTI incidence and were included in the analysis of the primary outcome. Change in antimicrobial resistance of urinary and faecal bacteria was monitored as a secondary outcome. The AnTIC trial is registered at ISRCTN, number 67145101; and EudraCT, number 2013-002556-32.
FINDINGS
Between Nov 25, 2013, and Jan 29, 2016, we screened 1743 adult users of CISC for eligibility, of whom 404 (23%) participants were enrolled between Nov 26, 2013, and Jan 31, 2016. Of these 404 participants, 203 (50%) were allocated to receive prophylaxis and 201 (50%) to receive no prophylaxis. 1339 participants were excluded before randomisation. The primary analysis included 181 (89%) adults allocated to the prophylaxis group and 180 (90%) adults in the no prophylaxis (control) group. 22 participants in the prophylaxis group and 21 participants in the control group were not included in the primary analysis because they were missing follow-up data before 6 months. The incidence of symptomatic antibiotic-treated UTIs over 12 months was 1·3 cases per person-year (95% CI 1·1-1·6) in the prophylaxis group and 2·6 (2·3-2·9) in the control group, giving an incidence rate ratio of 0·52 (0·44-0·61; p<0·0001), indicating a 48% reduction in UTI frequency after treatment with prophylaxis. Use of prophylaxis was well tolerated: we recorded 22 minor adverse events in the prophylaxis group related to antibiotic prophylaxis during the study, predominantly gastrointestinal disturbance (six participants), skin rash (six participants), and candidal infection (four participants). However, resistance against the antibiotics used for UTI treatment was more frequent in urinary isolates from the prophylaxis group than in those from the control group at 9-12 months of trial participation (nitrofurantoin 12 [24%] of 51 participants from the prophylaxis group vs six [9%] of 64 participants from the control group with at least one isolate; p=0·038), trimethoprim (34 [67%] of 51 vs 21 [33%] of 64; p=0·0003), and co-trimoxazole (26 [53%] of 49 vs 15 [24%] of 62; p=0·002).
INTERPRETATION
Continuous antibiotic prophylaxis is effective in reducing UTI frequency in CISC users with recurrent UTIs, and it is well tolerated in these individuals. However, increased resistance of urinary bacteria is a concern that requires surveillance if prophylaxis is started.
FUNDING
UK National Institute for Health Research.",2018,"p<0·0001), indicating a 48% reduction in UTI frequency after treatment with prophylaxis.","['predominantly gastrointestinal disturbance (six participants), skin rash (six participants), and candidal infection (four participants', 'adult users of CISC', '1339 participants were excluded before randomisation', 'adults with repeated urinary tract infections (AnTIC', 'The primary analysis included 181 (89%) adults allocated to the prophylaxis group and 180 (90%) adults in the no prophylaxis (control) group', 'CISC users with recurrent UTIs', 'participants were community-dwelling (as opposed to hospital inpatient) users of CISC with recurrent UTIs', '22 participants in the prophylaxis group and 21 participants in the control group were not included in the primary analysis because they were missing follow-up data before 6 months', 'Between Nov 25, 2013, and Jan 29, 2016, we screened 1743 adult users of CISC for eligibility, of whom 404 (23%) participants were enrolled between Nov 26, 2013, and Jan 31, 2016', '404 participants, 203 (50', 'enrolled participants from 51 UK National Health Service organisations', 'people who use clean intermittent self-catheterisation (CISC) to empty their bladder']","['antibiotic prophylaxis once daily (prophylaxis group) or no prophylaxis (control group) for 12 months by use of an internet-based system with permuted blocks of variable length', 'trimethoprim', 'continuous low-dose antibiotic prophylaxis', 'Continuous low-dose antibiotic prophylaxis']","['UTI frequency', 'tolerated', 'incidence of symptomatic, antibiotic-treated UTIs', 'incidence rate ratio of 0·52', 'antimicrobial resistance of urinary and faecal bacteria', 'incidence of symptomatic antibiotic-treated UTIs']","[{'cui': 'C0232459', 'cui_str': 'Impaired digestion'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0006840', 'cui_str': 'Moniliasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0473154', 'cui_str': 'Clean intermittent self-catheterization (procedure)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}]","[{'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}]",1339.0,0.194261,"p<0·0001), indicating a 48% reduction in UTI frequency after treatment with prophylaxis.","[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. Electronic address: holly.fisher@newcastle.ac.uk.'}, {'ForeName': 'Yemi', 'Initials': 'Y', 'LastName': 'Oluboyede', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chadwick', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Fattah', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Brennand', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Fader', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'Department of Urology, Mid-Yorkshire Hospitals NHS Trust, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hilton', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larcombe', 'Affiliation': 'Skerne Medical Centre, Sedgefield, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""N'Dow"", 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ternent', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nikesh', 'Initials': 'N', 'LastName': 'Thiruchelvam', 'Affiliation': 'Department of Urology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Timoney', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Walton', 'Affiliation': 'Department of Microbiology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'von Wilamowitz-Moellendorff', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pickard', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30279-2']
1657,31646599,Effect of probiotics on the occurrence of nutrition absorption capacities in healthy children: a randomized double-blinded placebo-controlled pilot study.,"OBJECTIVE
Recent advances in the translational research showed that dietary nutrients have critical importance to the microbioma balance in the gastrointestinal tract. Therefore, the alteration of the intestinal microbiota in order to achieve, restore, and maintain favorable balance in the ecosystem, and the activity of microorganisms present in the gastrointestinal tract is necessary for the improved health condition of the host. The objective of this translational study was to evaluate, in a pediatric population, the efficacy and safety of prophylactic probiotics for a better nutritional absorption capacity in the view to enhance their overall health and immunity.
PATIENTS AND METHODS
A total of 40 pediatric patients between the ages of 14 and 18 years were enrolled in the study and divided under two categories (treated/active group and placebo group). Three-time points clinical evaluations were performed: a baseline assessment (Time 0), a second evaluation at 5 weeks after the start of probiotic use (Time 1), and a final evaluation at the timeline after 10 weeks (Time 2). In the initial phase of the study, the recruited subjects underwent a panel of initial T0 clinical tests. For each of the patients, a blood sample was taken in order to evaluate the following biochemical measurements: Vitamin D, Vitamin A, Calcium, Zinc, and Iron. Moreover, an initial nutritional evaluation was carried out through which the nutritionist estimated the body composition of the subject (weight and body mass index), the caloric needs and dietary behaviour of each recruited patient.
RESULTS
Eligible participants were randomized into placebo (n = 20) or treated/active (n = 20) treatment conditions by random allocation using a computerized random number generator, ensuring all investigators remained blind to the treatment distribution. The data were compared within and between groups using statistical methods. The results confirmed that the probiotic supplementation was effective in increasing the overall blood biomarkers levels of vitamins, calcium, and mineral absorption from baseline to 10 weeks of treatment, compared with the placebo.
CONCLUSIONS
Probiotics may be suggested as supplements to improve biomarkers serum concentration if administered for a period of at least ≥ 5 weeks. However, further studies are required for optimal recommendations in patient treatment.",2019,"The results confirmed that the probiotic supplementation was effective in increasing the overall blood biomarkers levels of vitamins, calcium, and mineral absorption from baseline to 10 weeks of treatment, compared with the placebo.
","['healthy children', '40 pediatric patients between the ages of 14 and 18 years were enrolled in the study and divided under two categories (treated/active group and']","['prophylactic probiotics', 'placebo', 'probiotic supplementation', 'probiotics', 'Vitamin D, Vitamin A, Calcium, Zinc, and Iron']","['nutrition absorption capacities', 'overall blood biomarkers levels of vitamins, calcium, and mineral absorption']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}]",40.0,0.111911,"The results confirmed that the probiotic supplementation was effective in increasing the overall blood biomarkers levels of vitamins, calcium, and mineral absorption from baseline to 10 weeks of treatment, compared with the placebo.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ballini', 'Affiliation': 'Department of Biosciences, Biotechnologies and Biopharmaceutics, University of Bari ""Aldo Moro"", Bari, Italy. salvatore.scacco@uniba.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gnoni', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'De Vito', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dipalma', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cantore', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gargiulo Isacco', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Saini', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Santacroce', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Topi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Scarano', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Scacco', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Inchingolo', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201910_19182']
1658,30015546,The immediate and 1-week effects of mid-thoracic thrust manipulation on lower extremity passive range of motion.,"BACKGROUND
Research suggests that spinal manipulation may effect motion. Less clear is whether this effect is limited to localized responses or may involve generalizable changes. Objective : To determine whether Mid-thoracic manipulation (MTM) would result in a significant change in the lower extremity passive straight leg raise (PSLR) range of motion immediately and after 1 week. Methods : Twenty-three healthy subjects were randomly assigned in a double-blinded study. An experimental group received MTM and a control group received a sham intervention. PSLR measurements were taken prior to, immediately after, and one week after the intervention. Results : Mixed model repeated measure analysis of variance was used to determine that there was a significant interaction between MTM and time ( F (2, 21) = 3.84, p < 0.05). Post hoc tests revealed a significant difference between the pretest to immediate posttest values ( p < 0.05, SE = 1.47). PSLR in the MTM group increased 10.3° while the sham group increased 1.9°. Difference was non-significant between pretest and 1-week follow-up ( p = 0.129, SE = 2.46). Conclusions : MTM may immediately increase lower extremity passive range of motion, but the effect was lost by the 1-week follow-up. This supports evolving research suggesting that spinal manipulation may have a generalized but transient physiological effect.",2020,"Post hoc tests revealed a significant difference between the pretest to immediate posttest values (p < 0.05, SE = 1.47).",['Twenty-three healthy subjects'],"['mid-thoracic thrust manipulation', 'Mid-thoracic manipulation (MTM', 'MTM', 'sham intervention']","['extremity passive range of motion', 'PSLR', 'lower extremity passive range of motion']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",23.0,0.0855578,"Post hoc tests revealed a significant difference between the pretest to immediate posttest values (p < 0.05, SE = 1.47).","[{'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Sueki', 'Affiliation': 'Department of Physical Therapy, Azusa Pacific University , Azusa, CA, USA.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Almaria', 'Affiliation': 'Peak Sports Medicine and Rehabilitation , Phoenix, AZ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bender', 'Affiliation': 'Performax Elite , Burbank, CA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McConnell', 'Affiliation': 'Healthcare Partners , Torrance, CA, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1492056']
1659,31646593,The effect of the octenidine-based oral antiseptic on the structure of microbial communities and periodontal status in patients with fixed orthodontic treatments.,"OBJECTIVE
To evaluate the effect of an octenidine (OCT)-based antiseptic on the gingival inflammation and microbial composition of subgingival dental plaque in patients with fixed orthodontic appliances.
PATIENTS AND METHODS
Thirty-three orthodontic patients were randomized into 2 groups. The control group patients were given standard oral hygiene and dietary advice, while the experimental group patients used an OCT-based antiseptic together with standard oral hygiene and dietary recommendations. The periodontal status was evaluated using the following indices: the plaque index (PI), the gingival index (GI), the papilla bleeding index (PBI) and the probing pocket depth (PD). Next Generation Sequencing of the 16S rRNA amplicons was performed in order to assess the subgingival microbiome.
RESULTS
The PD values obtained were significantly lower in the experimental group after one month, as well as PBI. The microbiological analysis showed a significant increase in the occurrence of the genus Prevotella in the control group, while the number of other periodontopathogens remained stable in both groups. The changes in the abundance of the bacteria not directly associated with periodontal disease were also observed.
CONCLUSIONS
The use of an OCT-based antiseptic has a positive effect on the prevention of gingival inflammation. Additionally, it also prevents a likely increase in numbers of periodontopathogens of the subgingival dental plaque in the first three months of fixed orthodontic treatment.",2019,"The microbiological analysis showed a significant increase in the occurrence of the genus Prevotella in the control group, while the number of other periodontopathogens remained stable in both groups.","['patients with fixed orthodontic treatments', 'patients with fixed orthodontic appliances', 'Thirty-three orthodontic patients']","['octenidine (OCT)-based antiseptic', 'OCT-based antiseptic', 'standard oral hygiene and dietary advice, while the experimental group patients used an OCT-based antiseptic together with standard oral hygiene and dietary recommendations', 'octenidine-based oral antiseptic']","['numbers of periodontopathogens of the subgingival dental plaque', 'plaque index (PI), the gingival index (GI), the papilla bleeding index (PBI) and the probing pocket depth (PD', 'gingival inflammation and microbial composition of subgingival dental plaque', 'PD values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}]","[{'cui': 'C0069351', 'cui_str': 'octenidine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011389', 'cui_str': 'Dental Plaque'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0220389,"The microbiological analysis showed a significant increase in the occurrence of the genus Prevotella in the control group, while the number of other periodontopathogens remained stable in both groups.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vidović', 'Affiliation': 'Department of Dentistry, Faculty of Medicine, University of Niš, Niš, Serbia. ivica.tamas@dbe.uns.ac.rs.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Gušić', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tamaš', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mihajlović', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mitić', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Obradović', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Radovanović', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brkić', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201910_19176']
1660,30885518,Regular Sunscreen Use and Risk of Mortality: Long-Term Follow-up of a Skin Cancer Prevention Trial.,"INTRODUCTION
Sunscreen is widely used to protect the skin from harmful effects of sun exposure. However, there are concerns that sunscreens may negatively affect overall health. Evidence of the general safety of long-term regular sunscreen use is therefore needed.
METHODS
The effect of long-term sunscreen use on mortality was assessed over a 21-year period (1993-2014) among 1,621 Australian adults who had participated in a randomized skin cancer prevention trial of regular versus discretionary sunscreen use (1992-1996). In 2018, an intention-to-treat analysis was conducted using Cox proportional hazards regression to compare death rates in people who were randomized to apply sunscreen daily for 4.5years, versus randomized to use sunscreen at their usual, discretionary level. All-cause mortality and deaths resulting from cardiovascular disease, cancer, and other causes were considered.
RESULTS
In total, 160 deaths occurred in the daily sunscreen group compared with 170 deaths in the discretionary sunscreen group (hazard ratio=0.94, 95% CI=0.76, 1.17); 59vs 76 cardiovascular disease deaths (hazard ratio=0.77, 95% CI=0.55, 1.08), 63vs 58 cancer deaths (hazard ratio=1.09, 95% CI=0.76, 1.57), and 45vs 44 deaths resulting from other causes (hazard ratio=1.02, 95% CI=0.67, 1.54) occurred respectively.
CONCLUSIONS
Regular use of a sun protection factor 16 sunscreen on head, neck, arms, and hands for 4.5years did not increase mortality.",2019,"In total, 160 deaths occurred in the daily sunscreen group compared with 170 deaths in the discretionary sunscreen group (hazard","['1,621 Australian adults who had participated in a randomized skin cancer prevention trial of regular versus discretionary sunscreen use (1992-1996']",['long-term sunscreen'],"['mortality', '59vs 76 cardiovascular disease deaths', 'Regular Sunscreen Use and Risk of Mortality', 'cancer deaths']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",,0.317672,"In total, 160 deaths occurred in the daily sunscreen group compared with 170 deaths in the discretionary sunscreen group (hazard","[{'ForeName': 'Akiaja R', 'Initials': 'AR', 'LastName': 'Lindstrom', 'Affiliation': 'Cancer and Population Studies Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Lena A', 'Initials': 'LA', 'LastName': 'von Schuckmann', 'Affiliation': 'Cancer and Population Studies Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Maria Celia B', 'Initials': 'MCB', 'LastName': 'Hughes', 'Affiliation': 'Cancer and Population Studies Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Williams', 'Affiliation': 'School of Public Health, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Adele C', 'Initials': 'AC', 'LastName': 'Green', 'Affiliation': 'Cancer and Population Studies Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia; CRUK Manchester Institute and Faculty of Biology Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Jolieke C', 'Initials': 'JC', 'LastName': 'van der Pols', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Australia. Electronic address: j.vanderpols@qut.edu.au.'}]",American journal of preventive medicine,['10.1016/j.amepre.2018.11.025']
1661,31639775,A simple method to reduce halitosis; tongue scraping with probiotics.,"OBJECTIVE
We aimed to assess the effects of probiotic implantation to the dorsum of the tongue against halitosis.
MATERIALS AND METHODS
100 participants were randomly divided into three groups as tongue back scraping (TS), probiotic implantation to the dorsum of the tongue (PB) and mouthwash alone as the control group (MW). Measurements were taken before the treatment, after the first month of treatment and one month after the cessation of treatment.
RESULTS
Halimeter, winkel and woodlight scores were evaluated initially, in the first month and after the cessation of the treatment. All of MW measurements showed no difference throughout the study. All of TS measurements decreased significantly in the first month (p < 0.05) but rose again in the final count. All of PB measurements significantly decreased in the first month and kept their low levels after the cessation of the treatment (p < 0.05).
CONCLUSION
Probiotics and tongue scraping are widely used against halitosis but they are not intended to be used together. In this study, we proposed and proved an effective method of probiotic implantation by tongue scraping and showed that halitosis did not recur after the cessation of the treatment.",2019,All of TS measurements decreased significantly in the first month (p<0.05) but rose again in the final count.,['100 participants'],"['probiotic implantation', 'tongue back scraping (TS), probiotic implantation to the dorsum of the tongue (PB) and mouthwash alone as the control group (MW']","['PB measurements', 'TS measurements', 'Halimeter, winkel and woodlight scores']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0184933', 'cui_str': 'Scraping (procedure)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",100.0,0.0170555,All of TS measurements decreased significantly in the first month (p<0.05) but rose again in the final count.,"[{'ForeName': 'Berk', 'Initials': 'B', 'LastName': 'Gurpinar', 'Affiliation': 'Okmeydani Training and Research Hospital, Department of Otolaryngology, Istanbul, Turkey.'}, {'ForeName': 'Güven', 'Initials': 'G', 'LastName': 'Yildirim', 'Affiliation': ''}, {'ForeName': 'Tolgar Lütfi', 'Initials': 'TL', 'LastName': 'Kumral', 'Affiliation': ''}, {'ForeName': 'Muhammed Fatih', 'Initials': 'MF', 'LastName': 'Akgun', 'Affiliation': ''}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Sari', 'Affiliation': ''}, {'ForeName': 'Belgin', 'Initials': 'B', 'LastName': 'Tutar', 'Affiliation': ''}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Uyar', 'Affiliation': ''}]",Journal of breath research,['10.1088/1752-7163/ab503e']
1662,29873709,Achieved diastolic blood pressure and pulse pressure at target systolic blood pressure (120-140 mmHg) and cardiovascular outcomes in high-risk patients: results from ONTARGET and TRANSCEND trials.,"Aims
Current guidelines of hypertensive management recommend upper limits for systolic (SBP) and diastolic blood pressure (DBP). J-curve associations of BP with risk exist for some outcomes suggesting that lower limits of DBP goals may also apply. We examined the association between mean attained DBP and cardiovascular (CV) outcomes in patients who achieved an on-treatment SBP in the range of 120 to <140 mmHg in the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET) and Telmisartan Randomized AssessmeNt Study in ACE iNtolerant participants with cardiovascular Disease (TRANSCEND) trials on patients with high CV risk. This SBP range was associated with the lowest CV risk.
Methods
We analysed the outcome data from patients age 55 years or older with CV disease from the ONTARGET and TRANSCEND trials that randomized high-risk patients to ramipril, telmisartan, and the combination. In patients with controlled SBP (on-treatment 120 to <140 mmHg), the composite outcome of CV death, myocardial infarction, stroke and hospital admission for heart failure, the components thereof, and all-cause mortality were analysed according to mean on-treatment DBP as categorical (<70, 70 to <80, 80 to <90, and ≥90 mmHg) and continuous variable as well as the change of DBP according to baseline DBP. Pulse pressure (PP) was related to outcomes as a continuous variable.
Results
In 16 099 of 31 546 patients, mean achieved SBP was 120 to <140 mmHg. The nominally lowest risk for all outcomes was observed at an achieved DBP of 70 to <80 mmHg. A higher achieved DBP was associated with a higher risk for the outcomes of stroke and of hospitalization for heart failure (≥80 mmHg) and myocardial infarction (≥90 mmHg). A lower achieved DBP (<70 mmHg) was associated with a higher risk for the primary outcome [hazard ratio (HR) 1.29, 95% confidence interval (95% CI) 1.15-1.45; P < 0.0001], myocardial infarction HR 1.54 (95% CI 1.26-1.88, P < 0.0001) and hospitalization for heart failure HR 1.81 (95% CI 1.47-2.24, P < 0.0001) and all-cause death (HR 1.19, 95% CI 1.04-1.35; P < 0.0001) while there was no signal for stroke and CV death compared to DBP 70 to <80 mmHg. A decrease of DBP was associated with lower risk when baseline DBP was >80 mmHg. The associations to outcomes were similar when patients were divided to SBP 120 to <130 mmHg or 130 to <140 mmHg for DBP or PP.
Conclusion
Compared to a DBP of 70 to <80 mmHg, lower and higher DBP was associated with a higher risk in patients achieving a SBP of 120 to <140 mmHg. Associations of DBP and PP to risk were similar notably at controlled SBP. These data suggest at optimal achieved SBP, risk is still defined by low or high DBP. These findings support guidelines which take DBP at optimal SBP control into consideration.",2018,A higher achieved DBP was associated with a higher risk for the outcomes of stroke and of hospitalization for heart failure (≥80 mmHg) and myocardial infarction (≥90 mmHg).,"['patients age 55\u2009years or older with CV disease from the', 'patients who achieved an on-treatment SBP in the range of 120 to <140\u2009mmHg in the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET) and Telmisartan Randomized AssessmeNt Study in ACE iNtolerant participants with cardiovascular Disease (TRANSCEND) trials on patients with high CV risk']","['ramipril, telmisartan, and the combination', 'ONTARGET']","['DBP', 'systolic (SBP) and diastolic blood pressure (DBP', 'signal for stroke and CV death', 'SBP', 'composite outcome of CV death, myocardial infarction, stroke and hospital admission for heart failure, the components thereof, and all-cause mortality', 'myocardial infarction HR', 'cause death', 'cardiovascular outcomes', 'myocardial infarction', 'diastolic blood pressure and pulse pressure at target systolic blood pressure', 'Pulse pressure (PP', 'hospitalization for heart failure HR', 'mean attained DBP and cardiovascular (CV) outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",31546.0,0.0511966,A higher achieved DBP was associated with a higher risk for the outcomes of stroke and of hospitalization for heart failure (≥80 mmHg) and myocardial infarction (≥90 mmHg).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schumacher', 'Affiliation': 'Statistical Consultant, 55216 Ingelheim, Germany.'}, {'ForeName': 'Koon K', 'Initials': 'KK', 'LastName': 'Teo', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON L8L 2X2, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lonn', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON L8L 2X2, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, 80804 Munich-Schwabing and Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University, 91054 Erlangen/Nuremberg, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': ""Istituto Clinico Universitario Policlinico di Monza, Università degli Studi di Milano Bicocca, Piazza dell'Ateneo Nuovo, 1, 20126 Milano MI, Italy.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Redon', 'Affiliation': 'Hypertension Unit, Hospital Clínico Universitario, Av. de Blasco Ibáñez, 13, 46010 València, Spain.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University, 91054 Erlangen/Nuremberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Downstate College of Medicine, State University of New York, 450 Clarkson Ave, Brooklyn, NY 11203, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'Hatter Institute for Cardiovascular Research in Africa & IIDMM, Faculty of Health Sciences, University of Cape Town, Private Bag X3 7935, Observatory, South Africa.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'University College London (UCL) Institute of Cardiovascular Science and National Institute for Health Research (NIHR) UCL Hospitals Biomedical Research Centre, 149 Tottenham Court Road, London W1T 7DN, UK.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON L8L 2X2, Canada.'}]",European heart journal,['10.1093/eurheartj/ehy287']
1663,31642933,Simulation of Health and Economic Benefits of Extended Observation of Resolved Anaphylaxis.,"Importance
Biphasic anaphylaxis may occur in up to 20% of patients with anaphylaxis; however, the optimal observation time of patients with resolved anaphylaxis is unknown.
Objective
To characterize the cost-effectiveness of short vs prolonged medical observation times after resolved anaphylaxis.
Design, Setting, and Participants
An economic evaluation was performed of computer-simulated adult patients observed in outpatient allergy clinics and emergency departments, with rates of biphasic anaphylaxis derived from a 2019 meta-analysis.
Exposures
Computer-simulated patients (10 000 per strategy) were randomized to undergo 1 hour of medical observation (associated with 95% negative predictive value of biphasic anaphylaxis) or 6 or more hours of observation (associated with a 97.3% negative predictive value of biphasic anaphylaxis).
Main Outcomes and Measures
Cost-effectiveness of 6- to 24-hour medical observation of resolved anaphylaxis evaluated at willingness-to-pay thresholds of $10 000 per case of biphasic anaphylaxis observed and $10 million per death prevented, assuming that observation is associated with a 10- to 1000-fold reduction in the risk of death due to biphasic anaphylaxis.
Results
Biphasic anaphylaxis occurred after hospital discharge in 365 patients observed for 1 hour and in 213 patients undergoing prolonged observation. From a health care sector perspective, with medical observation costs of $286.92 per hour, the incremental cost of extended medical observation of resolved anaphylaxis (1 hour vs 6 hours) was $62 374 per case of biphasic anaphylaxis identified ($68 411 from the societal perspective). In Monte Carlo simulations, with hourly costs ranging from $100 to $500 and extended observation ranging from 6 to 24 hours (health care sector perspective), the mean (SD) costs were $295.36 ($81.22) for 1 hour of observation vs $3540.42 ($1626.67) for extended observation. The incremental cost-effectiveness ratio was $213 439 per biphasic anaphylaxis observed ($230 202 from the societal perspective). A 6-hour observation could be cost-effective if the risk of biphasic anaphylaxis after 1-hour observation of resolved anaphylaxis was 17% or if hourly observation costs were less than $46 in the base case. Cost-effectiveness could also be achieved (willingness-to-pay of $10 million per death prevented, health care sector perspective) when a baseline fatality rate of 0.33% per biphasic anaphylactic event was assumed, with a no greater than 24% relative risk of fatality associated with 6-hour observation.
Conclusions and Relevance
This study indicates that prolonged medical observation (6-24 hours) for resolved anaphylaxis may not be cost-effective for patients at low risk for biphasic anaphylaxis; however, in particular clinical circumstances of low observation costs, high postdischarge risk of biphasic anaphylaxis, or large incremental fatality risk reduction associated with extended observation, longer medical observation can be justified.",2019,"This study indicates that prolonged medical observation (6-24 hours) for resolved anaphylaxis may not be cost-effective for patients at low risk for biphasic anaphylaxis; however, in particular clinical circumstances of low observation costs, high postdischarge risk of biphasic anaphylaxis, or large incremental fatality risk reduction associated with extended observation, longer medical observation can be justified.","['patients (10\u202f000 per strategy', 'adult patients observed in outpatient allergy clinics and emergency departments, with rates of biphasic anaphylaxis derived from a 2019 meta-analysis', '365 patients observed for 1 hour and in 213 patients undergoing prolonged observation']","['computer-simulated', 'Exposures\n\n\nComputer-simulated']","['incremental cost-effectiveness ratio', 'Cost-effectiveness', 'mean (SD) costs', 'Measures\n\n\nCost-effectiveness of 6- to 24-hour medical observation of resolved anaphylaxis evaluated at willingness-to-pay thresholds', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3810819', 'cui_str': 'Allergy clinic'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0948564', 'cui_str': 'Medical observation'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]",365.0,0.0331095,"This study indicates that prolonged medical observation (6-24 hours) for resolved anaphylaxis may not be cost-effective for patients at low risk for biphasic anaphylaxis; however, in particular clinical circumstances of low observation costs, high postdischarge risk of biphasic anaphylaxis, or large incremental fatality risk reduction associated with extended observation, longer medical observation can be justified.","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Shaker', 'Affiliation': 'Section of Allergy and Immunology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'Nova Southeastern Allopathic Medical School, Fort Lauderdale, Florida.'}, {'ForeName': 'David B K', 'Initials': 'DBK', 'LastName': 'Golden', 'Affiliation': 'Division of Allergy-Clinical Immunology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Oppenheimer', 'Affiliation': 'Department of Internal Medicine, UMDMJ-Rutgers New Jersey Medical School, Newark.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Children's Hospital Colorado, University of Colorado School of Medicine, Section of Allergy and Immunology, Food Challenge and Research Unit, Aurora.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.13951']
1664,31620939,"Clinical efficacy of Lactobacillus reuteri-containing lozenges in the supportive therapy of generalized periodontitis stage III and IV, grade C: 1-year results of a double-blind randomized placebo-controlled pilot study.","OBJECTIVE
The aim of this 12-month mono-centre double-blind randomized placebo-controlled clinical study was to evaluate the efficacy of Lactobacillus reuteri-containing lozenges during the supportive therapy of generalized periodontitis stage III and IV, grade C (GPIII-IVC) patients.
MATERIAL AND METHODS
Twenty treated GPIII-IVC patients were randomly divided into 2 groups. The test group received two 3-month-long administrations of L. reuteri (2 lozenges/day after brushing) with a 3-month washout period, while the control one received a placebo. Outcome measures were tooth survival, complications and adverse events, change in probing pockets depth (PPD), change in probing attachment level (PAL), presence of bleeding on probing (BOP) and patient's evaluation of treatment. Measurements were collected at 3, 6, 9 and 12 months.
RESULTS
At 1 year, no dropout, tooth loss, complications or adverse event were recorded. Mean PPD and mean PAL and percentages of sites with BOP were statistically improved (p < 0.05) compared with baseline in both groups, while more PPD reduction at all time points (p < 0.05) and more PAL gain at 6 months and more BOP reduction at 6 and 9 months were found in the probiotic group (p < 0.05).
CONCLUSIONS
Within the limitation of the study, the use of L. reuteri probiotics lozenges improved some clinical outcomes in treated GPIII-IVC patients during maintenance therapy. Studies with a larger number of patients are needed to confirm these data.
CLINICAL RELEVANCE
The use of L. reuteri probiotic lozenges could be considered as an adjunct in the maintenance therapy of GPIII-IVC patients.",2020,"Mean PPD and mean PAL and percentages of sites with BOP were statistically improved (p < 0.05) compared with baseline in both groups, while more PPD reduction at all time points (p < 0.05) and more PAL gain at 6 months and more BOP reduction at 6 and 9 months were found in the probiotic group (p < 0.05).
","['generalized periodontitis stage III and IV, grade C (GPIII-IVC) patients', 'Twenty treated GPIII-IVC patients', 'GPIII-IVC patients', 'generalized periodontitis stage III and IV, grade C', 'treated GPIII-IVC patients during maintenance therapy']","['placebo', 'L. reuteri probiotic lozenges', 'Lactobacillus reuteri-containing lozenges']","[""tooth survival, complications and adverse events, change in probing pockets depth (PPD), change in probing attachment level (PAL), presence of bleeding on probing (BOP) and patient's evaluation of treatment"", 'BOP reduction', 'dropout, tooth loss, complications or adverse event', 'PAL gain', 'Mean PPD and mean PAL and percentages of sites with BOP', 'PPD reduction']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441807', 'cui_str': 'Grade C (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080233', 'cui_str': 'Tooth Loss'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",,0.306097,"Mean PPD and mean PAL and percentages of sites with BOP were statistically improved (p < 0.05) compared with baseline in both groups, while more PPD reduction at all time points (p < 0.05) and more PAL gain at 6 months and more BOP reduction at 6 and 9 months were found in the probiotic group (p < 0.05).
","[{'ForeName': 'Maria Gabriella', 'Initials': 'MG', 'LastName': 'Grusovin', 'Affiliation': 'School of Dentistry, Dentistry Department, Vita-Salute San Raffaele University, Via Olgettina n 48, 20132, Milan, Italy. Gabri.grusovin@tiscali.it.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Bossini', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Calza', 'Affiliation': 'Unit of Biostatistics & Bioinformatics, Department of Molecular and Translational Medicine, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Cappa', 'Affiliation': 'Unit of Biostatistics & Bioinformatics, Department of Molecular and Translational Medicine, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Garzetti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Eleonara', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}, {'ForeName': 'Enrico Felice', 'Initials': 'EF', 'LastName': 'Gherlone', 'Affiliation': 'School of Dentistry, Dentistry Department, Vita-Salute San Raffaele University, Via Olgettina n 48, 20132, Milan, Italy.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Mensi', 'Affiliation': 'Section of Periodontics, School of Dentistry, Department of Surgical Specialties, Radiological Science and Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.'}]",Clinical oral investigations,['10.1007/s00784-019-03065-x']
1665,31557064,Neoadjuvant Modified FOLFOX6 With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Final Results of the Chinese FOWARC Trial.,"PURPOSE
In the multicenter, open-label, phase III FOWARC trial, modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy resulted in a higher pathologic complete response rate than fluorouracil plus radiotherapy in Chinese patients with locally advanced rectal cancer. Here, we report the final results.
METHODS
Adults ages 18 to 75 years with stage II/III rectal cancer were randomly assigned (1:1:1) to five cycles of infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2 over 48 hours) plus radiotherapy (46.0 to 50.4 Gy delivered in 23 to 25 fractions during cycles 2 to 4) followed by surgery and seven cycles of infusional fluorouracil, the same treatment plus intravenous oxaliplatin 85 mg/m 2 on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6. The primary end point was 3-year disease-free survival (DFS).
RESULTS
In total, 495 patients were randomly assigned to treatment. After a median follow-up of 45.2 months, DFS events were reported in 46, 39, and 46 patients in the fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy, and mFOLFOX6 arms. In each arm, the probability of 3-year DFS was 72.9%, 77.2%, and 73.5% ( P = .709 by the log-rank test), the 3-year probability of local recurrence after R0/1 resection was 8.0%, 7.0%, and 8.3% ( P = .873 by the log-rank test), and the 3-year overall survival rate was 91.3%, 89.1%, and 90.7% ( P = .971 by log-rank test), respectively.
CONCLUSION
mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer. No significant difference in outcomes was found between mFOLFOX6 without radiotherapy and fluorouracil with radiotherapy, which requires additional investigation of the role of radiotherapy in these regimens.",2019,"CONCLUSION
mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","['Locally Advanced Rectal Cancer', 'Adults ages 18 to 75 years with stage II/III rectal cancer', 'patients with locally advanced rectal cancer', '495 patients', 'Chinese patients with locally advanced rectal cancer']","['fluorouracil with radiotherapy', 'fluorouracil with radiation', 'fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy', 'infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2 over 48 hours) plus radiotherapy', 'infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy', 'fluorouracil plus radiotherapy', 'Without Radiation Versus Fluorouracil Plus Radiation', 'infusional fluorouracil', 'oxaliplatin 85 mg/m 2 on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6', 'Neoadjuvant Modified FOLFOX6']","['3-year overall survival rate', 'probability of 3-year DFS', '3-year probability of local recurrence', '3-year DFS', '3-year disease-free survival (DFS', 'DFS events']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",495.0,0.0663218,"CONCLUSION
mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","[{'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': ""Fujian Medical University Union Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lan', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ""Xinhua Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Daoda', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Xiehe Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': ""The First People's Hospital, Guangzhou City, People's Republic of China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ""The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""The First People's Hospital, Foshan City, People's Republic of China.""}, {'ForeName': 'Zonghai', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Zhujiang Hospital, Nanfang University of Medical Science, Guangzhou, People's Republic of China.""}, {'ForeName': 'Guanfu', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': ""Guangdong Provincial Peoples Hospital, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhongcheng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""General Hospital, Hunan Province, Changsha, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""The First Affiliated Hospital, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Xinhua Hospital, Dongguan, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhiyang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Meijin', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Ren', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02309']
1666,31553471,Association of BCG Vaccination in Childhood With Subsequent Cancer Diagnoses: A 60-Year Follow-up of a Clinical Trial.,"Importance
The BCG vaccine is currently the only approved tuberculosis vaccine and is widely administered worldwide, usually during infancy. Previous studies found increased rates of lymphoma and leukemia in BCG-vaccinated populations.
Objective
To determine whether BCG vaccination was associated with cancer rates in a secondary analysis of a BCG vaccine trial.
Design, Setting, and Participants
Retrospective review (60-year follow-up) of a clinical trial in which participants were assigned to the vaccine group by systematic stratification by school district, age, and sex, then randomized by alternation. The original study was conducted at 9 sites in 5 US states between December 1935 and December 1998. Participants were 2963 American Indian and Alaska Native schoolchildren younger than 20 years with no evidence of previous tuberculosis infection. Statistical analysis was conducted between August 2018 and July 2019.
Interventions
Single intradermal injection of either BCG vaccine or saline placebo.
Main Outcomes and Measures
The primary outcome was diagnosis of cancer after BCG vaccination. Data on participant interval health and risk factors, including smoking, tuberculosis infection, isoniazid use, and other basic demographic information, were also collected.
Results
A total of 2963 participants, including 1540 in the BCG vaccine group and 1423 in the placebo group, remained after exclusions. Vaccination occurred at a median (interquartile range) age of 8 (5-11) years; 805 participants (52%) in the BCG group and 710 (50%) in the placebo group were female. At the time of follow-up, 97 participants (7%) in the placebo group and 106 participants (7%) in the BCG vaccine group could not be located; total mortality was 633 participants (44%) in the placebo group and 632 participants (41%) in the BCG group. The overall rate of cancer diagnosis was not significantly different in BCG vaccine vs placebo recipients (hazard ratio, 0.82; 95% CI, 0.66-1.02), including for lymphoma and leukemia. The rate of lung cancer was significantly lower in BCG vs placebo recipients (18.2 vs 45.4 cases per 100 000 person-years; hazard ratio, 0.38; 95% CI, 0.20-0.74; P = .005), controlling for sex, region, alcohol overuse, smoking, and tuberculosis.
Conclusions and Relevance
Childhood BCG vaccination was associated with a lower risk of lung cancer development in American Indian and Alaska Native populations. This finding has potentially important health implications given the high mortality rate associated with lung cancer and the availability of low-cost BCG vaccines.",2019,"The overall rate of cancer diagnosis was not significantly different in BCG vaccine vs placebo recipients (hazard ratio, 0.82; 95% CI, 0.66-1.02), including for lymphoma and leukemia.","['A total of 2963 participants, including 1540 in the BCG vaccine group and 1423 in the placebo group, remained after exclusions', '9 sites in 5 US states between December 1935 and December 1998', 'Childhood With Subsequent Cancer Diagnoses', 'Participants were 2963 American Indian and Alaska Native schoolchildren younger than 20 years with no evidence of previous tuberculosis infection']","['BCG Vaccination', 'BCG vaccination', 'BCG vaccine or saline placebo', 'placebo', 'vaccine', 'BCG vaccine']","['located; total mortality', 'participant interval health and risk factors, including smoking, tuberculosis infection, isoniazid use, and other basic demographic information', 'overall rate of cancer diagnosis', 'rate of lung cancer', 'Vaccination', 'cancer rates', 'rates of lymphoma and leukemia', 'diagnosis of cancer after BCG vaccination']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004886', 'cui_str': 'BCG Vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0199804', 'cui_str': 'BCG immunization'}, {'cui': 'C0004886', 'cui_str': 'BCG Vaccine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}]",805.0,0.459933,"The overall rate of cancer diagnosis was not significantly different in BCG vaccine vs placebo recipients (hazard ratio, 0.82; 95% CI, 0.66-1.02), including for lymphoma and leukemia.","[{'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Usher', 'Affiliation': 'Infectious Diseases Division, Uniformed Services University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Suyoung', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Division of Vaccines and Related Product Applications, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Howard', 'Affiliation': 'Department of Research Programs, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Department of Research Programs, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Harrison', 'Affiliation': 'Infectious Diseases Epidemiology Research Unit, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mathuram', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Health Systems Program, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Aronson', 'Affiliation': 'Infectious Diseases Division, Uniformed Services University of the Health Sciences, Bethesda, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.12014']
1667,29618919,Umbilical Quilting Suture Technique during Single-Port Laparoscopic Surgery.,"Background and Objectives
Single-port laparoscopic surgery (SPLS) is popular in the gynecological field, because it is less invasive and leaves a smaller scar. However, the postoperative shape of the umbilicus is often distorted due to the intensive procedures performed through the small opening. In this report, we describe a technique for forming a satisfactory umbilicus in SPLS.
Methods
From March 2016 through April 2017, 32 patients were treated with SPLS by a single gynecologic surgeon. Group A (14 cases) underwent conventional umbilicus closure, and group B (18 cases) underwent a quilting suture technique. The umbilical shapes of each group were assessed by a plastic surgeon as was the patients' satisfaction. Evaluations were performed immediately after surgery and every month for 6 months thereafter.
Results
The postoperative umbilical shape in group A showed features, such as loss of depression, disappearance of the central vertical line, and irregularly bulging tissue, whereas group B had a shape similar to that of the natural umbilicus and maintained its depression and vertical line. The average scores of the plastic surgeons' evaluations immediately after the operation were 10.4 for group A and 15.1 for group B. The final scores obtained 6 months after surgery were 15.2 and 17.8, respectively. The patients' satisfaction scores immediately after the operation were 4.9 for group A and 7.3 for group B. The scores increased gradually, to 8.1 and 9.2, respectively, at 6 months after surgery.
Conclusion
Performing quilting sutures during wound closure in SPLS is effective for making an ideal umbilicus and ensuring patients' satisfaction.",2018,The patients' satisfaction scores immediately after the operation were 4.9 for group A and 7.3 for group,"['Methods\n\n\nFrom March 2016 through April 2017', '32 patients were treated with SPLS by a single gynecologic surgeon']","['Umbilical Quilting Suture Technique during Single-Port Laparoscopic Surgery', 'conventional umbilicus closure', ' and Objectives\n\n\nSingle-port laparoscopic surgery (SPLS', 'quilting suture technique']","['postoperative umbilical shape', 'loss of depression, disappearance of the central vertical line, and irregularly bulging tissue']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0038968', 'cui_str': 'Suture Technics'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0041638', 'cui_str': 'Umbilicus'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C4044304', 'cui_str': 'Quilt'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",32.0,0.020098,The patients' satisfaction scores immediately after the operation were 4.9 for group A and 7.3 for group,"[{'ForeName': 'Jung Woo', 'Initials': 'JW', 'LastName': 'Chang', 'Affiliation': 'Department of Plastic and Reconstructive Surgery.'}, {'ForeName': 'Jeongseok', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Plastic and Reconstructive Surgery.'}, {'ForeName': 'Un Suk', 'Initials': 'US', 'LastName': 'Jung', 'Affiliation': 'Department of Obstetrics and Gynecology, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2017.00088']
1668,31629655,Triple strength utility of the Modified Drug Adherence Work-Up (M-DRAW) tool in a veterans affairs outpatient diabetes clinic.,"OBJECTIVE
The purpose of this study was to test the psychometric properties of the M-DRAW tool and to examine its applicability and utility at a primary clinic setting in patients with diabetes.
METHODS
A prospective, pre-post interview design study was conducted at the VA Loma Linda Health System (VALLHS) from 03/2017-03/2018. Eligibility criteria consisted of English-speaking patrons who were 18 years and older, diagnosed with Type 2 diabetes mellitus, residing in non-institutional setting, and having 1 + prescriptions for diabetes. A priming question about self-reported adherence was used to assign participants to control (Group A) or intervention (Group N). Pharmacist-led interventions were thus directed to those who recognized their medication nonadherence issue. The M-DRAW tool consisted of 13 statements about barriers to adherence on a 4-point frequency scale. A ""3 = sometimes"" or ""4 = often"" on each item indicated a barrier to adherence that was then addressed using the GUIDE strategy using motivational interviewing with the participant.
RESULTS
Of the 200 eligible individuals, 88 participants completed both baseline and follow-up assessments (Group A, n = 63; Group N, n = 25). Participants were male (98.8%), taking 7-8 medications on average, and using insulin (79.5%). The tool yielded good internal consistency (Cronbach's alpha = 0.873). Using confirmatory factor analysis, four factors were extracted with items loading as hypothesized. At baseline, group N identified three times greater number of barriers from the M-DRAW tool compared to Group A (5.1 items vs. 1.7, p < 0.05). At 3-month follow-up, a decrease in the number of barriers was observed among Group N. Both PDC and HbA1c did not result in statistically significant reduction in pre-post change.
CONCLUSIONS
The M-DRAW tool is shown to be reliable and valid. A tailored intervention reduced the number of barriers contributing to medication nonadherence and resulted in a trend of improved clinical outcomes.",2020,A tailored intervention reduced the number of barriers contributing to medication nonadherence and resulted in a trend of improved clinical outcomes.,"['Participants were male (98.8%), taking 7-8 medications on average, and using insulin (79.5', 'patients with diabetes', '200 eligible individuals', 'veterans affairs outpatient diabetes clinic', 'Eligibility criteria consisted of English-speaking patrons who were 18 years and older, diagnosed with Type 2 diabetes mellitus, residing in non-institutional setting, and having 1\xa0+\xa0prescriptions for diabetes']",['Modified Drug Adherence Work-Up (M-DRAW'],"['number of barriers contributing to medication nonadherence', 'number of barriers']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0746935', 'cui_str': 'Medication Non-Adherence'}]",88.0,0.0456353,A tailored intervention reduced the number of barriers contributing to medication nonadherence and resulted in a trend of improved clinical outcomes.,"[{'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'High Point University, School of Pharmacy, Department of Clinical Sciences, One University Parkway, High Point, NC, 27268, USA. Electronic address: slee1@highpoint.edu.'}, {'ForeName': 'Yuna H', 'Initials': 'YH', 'LastName': 'Bae-Shaaw', 'Affiliation': 'University of Southern California, School of Pharmacy, Schaeffer Center for Health Policy and Economics, 635 Downey Way, Verna & Peter Dauterive Hall (VPD), 2nd Floor, Los Angeles, CA, 90089, USA. Electronic address: hyojungb@usc.edu.'}, {'ForeName': 'Hyma', 'Initials': 'H', 'LastName': 'Gogineni', 'Affiliation': 'Western University of Health Sciences, College of Pharmacy, Department of Pharmacy Practice and Administration, 309 East Second Street., Pomona, CA, 91766, USA. Electronic address: hgogineni@westernu.edu.'}, {'ForeName': 'Marcia M', 'Initials': 'MM', 'LastName': 'Worley', 'Affiliation': 'The Ohio State University, College of Pharmacy, Division of Pharmacy Practice and Science, A214 Parks Hall, 500 W. 12th Avenue, Columbus, OH, 43210, USA. Electronic address: worley.18@osu.edu.'}, {'ForeName': 'Anandi V', 'Initials': 'AV', 'LastName': 'Law', 'Affiliation': 'Western University of Health Sciences, College of Pharmacy, Department of Pharmacy Practice and Administration, 309 East Second Street., Pomona, CA, 91766, USA. Electronic address: alaw@westernu.edu.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.09.063']
1669,31358379,"Re: Addition of Radium-223 to Abiraterone Acetate and Prednisone or Prednisolone in Patients with Castration-resistant Prostate Cancer and Bone Metastases (ERA 223): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial.",,2019,,['Patients with Castration-resistant Prostate Cancer and Bone Metastases (ERA 223'],"['Placebo', 'Radium-223 to Abiraterone Acetate and Prednisone or Prednisolone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]",[],,0.506997,,"[{'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van der Poel', 'Affiliation': 'Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: h.vd.poel@nki.nl.'}]",European urology,['10.1016/j.eururo.2019.07.021']
1670,31585725,"Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report.","BACKGROUND
Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children. Age restrictions and other limitations of existing oral live-attenuated typhoid and parenteral Vi polysaccharide vaccines have triggered the development of Vi conjugate vaccines with improved immunological properties, use in younger age range, and longer durability of protection. We present the safety, reactogenicity, and immunogenicity data from a Phase II study after a single dose of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) conducted in 6-23-month old Filipino children.
METHODS
This is a randomized, observer-blinded Phase II study to assess the immunogenicity, safety and reactogenicity of Vi-DT compared to placebo, conducted in Muntinlupa City, The Philippines. Participants aged 6-23 months were enrolled and randomized to Vi-DT (25 µg) or placebo (0.9% sodium chloride) and evaluated for immunogenicity and overall safety 28 days post vaccination.
RESULTS
A total of 285 participants were enrolled and age-stratified: 6 to < 9 months, 9-12 months, and 13-23 months. Seventy-six (76) participants received Vi-DT and 19 received placebo per each strata. All participants seroconverted after a single dose of Vi-DT versus 7% of placebo recipients. Anti-Vi IgG GMT was 444.38 [95% CI (400.28; 493.34)] after a single dose of Vi-DT; there was no change in GMT after placebo administration, 0.41 [95% CI (0.33; 0.51), p < 0.0001]. A similar pattern of immunogenicity was reported across all age strata. The vaccine reported to be safe and well tolerated.
CONCLUSIONS
Vi-DT vaccine was immunogenic, safe, and well tolerated in children aged 6-23 months. ClinicalTrials.gov registration number: NCT03527355.",2020,"BACKGROUND
Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","['Muntinlupa City, The Philippines', 'healthy Filipino infants and toddlers', 'school-aged children', 'Participants aged 6-23\u202fmonths', '6-23-month old Filipino children', '285 participants were enrolled and age-stratified: 6 to < 9\u202fmonths, 9-12\u202fmonths, and 13-23\u202fmonths', 'Seventy-six (76) participants received', 'children aged 6-23\u202fmonths']","['Vi-DT vaccine', 'Vi-DT', 'placebo (0.9% sodium chloride', 'placebo', 'Vi-DT typhoid conjugate vaccine', 'Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT']","['safety, reactogenicity, and immunogenicity data', 'GMT', 'Immunogenicity, safety and reactogenicity', 'safe and well tolerated', 'immunogenicity, safety and reactogenicity']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1556093', 'cui_str': 'Filipinos (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}]","[{'cui': 'C0058773', 'cui_str': 'DT Vaccine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",285.0,0.64885,"BACKGROUND
Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","[{'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Edison', 'Initials': 'E', 'LastName': 'Alberto', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Saluja', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea. Electronic address: tarun.saluja@ivi.int.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Teshome', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Ju Yeon', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Chinaworapong', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jiwook', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sue-Kyoung', 'Initials': 'SK', 'LastName': 'Jo', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chon', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Seon-Young', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Ham', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Hwa', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Hun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'T Anh', 'Initials': 'TA', 'LastName': 'Wartel', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sushant', 'Initials': 'S', 'LastName': 'Sahastrabuddhe', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}]",Vaccine,['10.1016/j.vaccine.2019.09.074']
1671,31621523,"Improving HbA 1c with Glucose Self-Monitoring in Diabetic Patients with EpxDiabetes, a Phone Call and Text Message-Based Telemedicine Platform: A Randomized Controlled Trial.","Background: We conducted a randomized controlled trial of EpxDiabetes, a novel digital health intervention as an adjunct therapy to reduce HbA 1c and fasting blood glucose (FBG) among patients with type 2 diabetes mellitus (T2DM). In addition, we examined the effect of social determinants of health on our system. Methods: Sixty-five ( n = 65) patients were randomized at a primary care clinic. Self-reported FBG data were collected by EpxDiabetes automated phone calls or text messages. Only intervention group responses were shared with providers, facilitating follow-up and bidirectional communication. ΔHbA 1c and ΔFBG were analyzed after 6 months. Results: There was an absolute HbA 1c reduction of 0.69% in the intervention group (95% confidence interval [CI], -1.41 to 0.02) and an absolute reduction of 0.03% in the control group (95% CI, -0.88 to 0.82). For those with baseline HbA 1c >8%, HbA 1c decreased significantly by 1.17% in the intervention group (95% CI, -1.90 to -0.44), and decreased by 0.02% in the control group (95% CI, -0.99 to 0.94). FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69). Engagement (proportion responding to ≥25% of texts or calls over 4 weeks) was 58% for the intervention group (95% CI, 0.373-0.627) and 48% for the control group (95% CI, 0.296-0.621). Smoking, number of comorbidities, and response rate were significant predictors of ΔHbA 1c . Conclusions: EpxDiabetes helps to reduce HbA 1c in patients with uncontrolled T2DM and fosters patient-provider communication; it has definite merit as an adjunct therapy in diabetes management. Future work will focus on improving the acceptability of the system and implementation on a larger scale trial.",2020,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","['Diabetic Patients with EpxDiabetes', 'Methods: Sixty-five ( n \u2009=\u200965', 'patients with type 2 diabetes mellitus (T2DM']",['novel digital health intervention'],"['FBG', 'HbA 1c and fasting blood glucose (FBG', 'HbA 1c', 'Smoking, number of comorbidities, and response rate', 'ΔHbA 1c and ΔFBG']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0600336,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Xing', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Kavon', 'Initials': 'K', 'LastName': 'Javaherian', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Peters', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Ross', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bernal-Mizrachi', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine, St. Louis, Missouri, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0035']
1672,29329957,"Safety and tolerability of a novel, polyclonal human anti-MERS coronavirus antibody produced from transchromosomic cattle: a phase 1 randomised, double-blind, single-dose-escalation study.","BACKGROUND
Middle East respiratory syndrome (MERS) is a severe respiratory illness with an overall mortality of 35%. There is no licensed or proven treatment. Passive immunotherapy approaches are being developed to prevent and treat several human medical conditions where alternative therapeutic options are absent. We report the safety of a fully human polyclonal IgG antibody (SAB-301) produced from the hyperimmune plasma of transchromosomic cattle immunised with a MERS coronavirus vaccine.
METHODS
We did a phase 1 double-blind, placebo-controlled, single-dose escalation trial at the National Institutes of Health Clinical Center. We recruited healthy participants aged 18-60 years who had normal laboratory parameters at enrolment, a body-mass index of 19-32 kg/m 2 , and a creatinine clearance of 70 mL/min or more, and who did not have any chronic medical problems that required daily oral medications, a positive rheumatoid factor (≥15 IU/mL), IgA deficiency (<7 mg/dL), or history of allergy to intravenous immunoglobulin or human blood products. Participants were randomly assigned by a computer-generated table, made by a masked pharmacist, to one of six cohorts (containing between three and ten participants each). Cohorts 1 and 2 had three participants, randomly assigned 2:1 to receive active drug SAB-301 versus normal saline placebo; cohorts 3 and 4 had six participants randomised 2:1; and cohorts 5 and 6 had ten participants, randomised 4:1. Participants received 1 mg/kg, 2·5 mg/kg, 5 mg/kg, 10 mg/kg, 20 mg/kg, or 50 mg/kg of SAB-301, or equivalent volume placebo (saline control), on day 0, and were followed up by clinical, laboratory, and pharmacokinetic assessments on days 1, 3, 7, 21, 42, and 90. The primary outcome was safety, and immunogenicity was a secondary outcome. We analysed the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02788188.
FINDINGS
Between June 2, 2016, and Jan 4, 2017, we screened 43 participants, of whom 38 were eligible and randomly assigned to receive SAB-301 (n=28) or placebo (n=10). 97 adverse events were reported: 64 adverse events occurred in 23 (82%) of 28 participants receiving SAB-301 (mean 2·3 adverse events per participant). 33 adverse events occurred in all ten participants receiving placebo (mean 3·3 adverse events per participant). The most common adverse events were headache (n=6 [21%] in participants who received SAB-301 and n=2 [20%] in those receiving placebo), albuminuria (n=5 [18%] vs n=2 [20%]), myalgia (n=3 [11%] vs n=1 [10%]), increased creatine kinase (n=3 [11%] vs 1 [10%]), and common cold (n=3 [11%] vs n=2 [20%]). There was one serious adverse event (hospital admission for suicide attempt) in one participant who received 50 mg/kg of SAB-301. The area under the concentration-time curve (AUC) in the 50 mg/kg dose (27 498 μg × days per mL) is comparable to the AUC that was associated with efficacy in a preclinical model.
INTERPRETATION
Single infusions of SAB-301 up to 50 mg/kg appear to be safe and well tolerated in healthy participants. Human immunoglobulin derived from transchromosomic cattle could offer a new platform technology to produce fully human polyclonal IgG antibodies for other medical conditions.
FUNDING
National Institute of Allergy and Infectious Diseases, National Institutes of Health, and Biomedical Advanced Research and Development Authority.",2018,97 adverse events were reported: 64 adverse events occurred in 23 (82%) of 28 participants receiving SAB-301 (mean 2·3 adverse events per participant).,"['Between June 2, 2016, and Jan 4, 2017, we screened 43 participants, of whom 38 were eligible and randomly assigned to receive', 'transchromosomic cattle', 'transchromosomic cattle immunised with a MERS coronavirus vaccine', 'healthy participants', 'Middle East respiratory syndrome (MERS', 'cohorts 3 and 4 had six participants randomised 2:1; and cohorts 5 and 6 had ten participants, randomised 4:1', 'healthy participants aged 18-60 years who had normal laboratory parameters at enrolment, a body-mass index of 19-32 kg/m 2 , and a creatinine clearance of 70 mL/min or more, and who did not have any chronic medical problems that required daily oral medications, a positive rheumatoid factor (≥15 IU/mL), IgA deficiency (<7 mg/dL), or history of allergy to intravenous immunoglobulin or human blood products']","['placebo', 'SAB-301, or equivalent volume placebo (saline control', 'active drug SAB-301 versus normal saline placebo', 'SAB-301', 'novel, polyclonal human anti-MERS coronavirus antibody', 'fully human polyclonal IgG antibody (SAB-301']","['33 adverse events', 'adverse events', 'increased creatine kinase', 'headache', 'area under the concentration-time curve (AUC', 'serious adverse event (hospital admission for suicide attempt', 'safety, and immunogenicity', 'myalgia', 'Safety and tolerability']","[{'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'TS-COV19'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3694279', 'cui_str': 'Middle East Respiratory Syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0201660', 'cui_str': 'Rheumatoid factor measurement (procedure)'}, {'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}, {'cui': 'C0162538', 'cui_str': 'IgA Deficiency'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C1533078', 'cui_str': 'Human blood product'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0369034', 'cui_str': 'Coronavirus antibody'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",43.0,0.732942,97 adverse events were reported: 64 adverse events occurred in 23 (82%) of 28 participants receiving SAB-301 (mean 2·3 adverse events per participant).,"[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'Leidos Biomedical Research Inc, Frederick, MD, USA. Electronic address: jbeigel@niaid.nih.gov.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Voell', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kanakatte', 'Initials': 'K', 'LastName': 'Raviprakash', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'SAB Biotherapeutics Inc, Sioux Falls, SD, USA.'}, {'ForeName': 'Jin-An', 'Initials': 'JA', 'LastName': 'Jiao', 'Affiliation': 'SAB Biotherapeutics Inc, Sioux Falls, SD, USA.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Sullivan', 'Affiliation': 'SAB Biotherapeutics Inc, Sioux Falls, SD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Luke', 'Affiliation': 'The Henry Jackson Foundation for the Advancement of Military Medicine, Silver Spring, MD, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30002-1']
1673,31454502,"Comparison of the Anesthetic Efficiency of Lidocaine and Tramadol Hydrochloride in Orthodontic Extractions: A Split-Mouth, Prospective, Randomized, Double-Blind Study.","PURPOSE
The aim of the present randomized controlled split-mouth clinical study was to evaluate and compare the clinical anesthetic efficacy of lidocaine and tramadol hydrochloride in orthodontic extractions.
MATERIALS AND METHODS
A total of 32 systemically healthy patients requiring bilaterally maxillary first premolar extractions for orthodontic reasons were included. Each patient received 1.8 mL of lidocaine (36 mg lidocaine HCI and 0.0225 mg epinephrine) on 1 side and 1.8 mL tramadol (50 mg tramadol HCl and 0.0225 mg epinephrine diluted to 1.8 mL by distilled water) on the other side. The anesthetic solutions were infiltrated into the buccal vestibule (local infiltration) based on a computer-generated list. In each patient, the time of anesthetic onset and finish, anesthetic activity, duration of postoperative analgesia, additional analgesic medication, wound healing, possible side effects, and satisfaction levels were recorded intraoperatively and postoperatively for both sides.
RESULTS
Although no relevant differences were found between the solutions for anesthetic onset, lidocaine was significantly more effective statistically for the total anesthesia duration. Comparing the anesthetic activity at 5 minutes before extraction, we found that tramadol was significantly more effective statistically compared with lidocaine. Similarly, tramadol was significantly more effective statistically than lidocaine for satisfaction level and wound healing. Moreover, compared with tramadol, in terms of postoperative pain, the visual analog scale scores with lidocaine were significantly higher at statistically 7, 8, 9, and 10 hours during the first 12 hours. In general, the lidocaine values were dramatically higher than were the tramadol values.
CONCLUSIONS
The results of the present study suggest that using tramadol combined with epinephrine can be an alternative local anesthetic for maxillary first premolar tooth extractions in oral-maxillofacial surgery.",2020,"Although no relevant differences were found between the solutions for anesthetic onset, lidocaine was significantly more effective statistically for the total anesthesia duration.","['32 systemically healthy patients requiring bilaterally maxillary first premolar extractions for orthodontic reasons were included', 'Orthodontic Extractions']","['tramadol HCl', 'tramadol combined with epinephrine', 'Lidocaine and Tramadol Hydrochloride', 'epinephrine', 'tramadol', 'lidocaine HCI and 0.0225\xa0mg epinephrine', 'lidocaine and tramadol hydrochloride', 'lidocaine']","['postoperative pain, the visual analog scale scores', 'satisfaction level and wound healing', 'time of anesthetic onset and finish, anesthetic activity, duration of postoperative analgesia, additional analgesic medication, wound healing, possible side effects, and satisfaction levels', 'anesthetic activity', 'clinical anesthetic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C2350089', 'cui_str': 'tramadol hydrochloride'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.133189,"Although no relevant differences were found between the solutions for anesthetic onset, lidocaine was significantly more effective statistically for the total anesthesia duration.","[{'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Ege', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey.'}, {'ForeName': 'Miray', 'Initials': 'M', 'LastName': 'Ege', 'Affiliation': 'Teaching Assistant, Department of Pharmacognosy, Faculty of Pharmacy, Adıyaman University, Adıyaman, Turkey. Electronic address: miregein@gmail.com.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Koparal', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Alan', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Inonu University, Malatya, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.07.010']
1674,31572076,Comparative evaluation of forced air warming and infusion of amino acid-enriched solution on intraoperative hypothermia in patients undergoing head and neck cancer surgeries: A prospective randomised study.,"Background
Inadvertent core hypothermia is a common occurrence during general anaesthesia. Forced air warming (FAW) is the most effective perianaesthetic warming system, but it may lead to thermal discomfort. Amino acids (AAs) have been used to prevent hypothermia, but no study has compared the effect of AA infusion with FAW systems. We have conducted this study to compare the effects of external heating (FAW system) and internal heat generation (AA infusion) in preventing hypothermia during anaesthesia.
Methods
After institutional review board approval, 80 American Society of Anesthesiologists Grade I/II adult patients admitted for head and neck cancer surgeries lasting more than 2 h under general anaesthesia were included. The patients were randomly divided into two groups using computer-generated codes to receive AA infusion at 3 mL/kg/h, Group AA ( N = 40), or normal saline at 3 mL/kg/h with FAW, Group FA ( N = 40) till the end of surgery. Standard anaesthetic technique and monitoring was used in all the patients.
Results
The baseline mean temperature in both the groups was comparable. The core temperature was similar in the two groups at 30 min (35.6 ± 0.54 vs 35.5 ± 0.54), 60 min (35.5 ± 0.63 vs 35.3 ± 0.60), 90 min (35.5 ± 0.79 vs 35.2 ± 0.66), 120 min (35.6 ± 0.93 vs 35.2 ± 0.78), 150 min (35.7 ± 0.88 vs 35.3 ± 0.89) and 180 min (35.8 ± 1.01 vs 35.3 ± 0.95) in Groups FA and AA, respectively ( P > 0.05). However, the core temperature was significantly higher in Group FA at 210 min (35.8 ± 1.0 vs 35.3 ± 0.85; P = 0.01), 240 min (35.9 ± 1.0 vs 35.4 ± 0.90; ( P = 0.001), 270 min (35.9 ± 1.12 vs 35.6 ± 0.97; P = 0.002) and 300 min (36.0 ± 1.12 vs 35.6 ± 1.02; P = 0.002), respectively. Clinically relevant hypothermia (at least one measurement <35.5°C) was comparable between the two groups.
Conclusion
The AA infusion can be used as an alternative to FAW in preventing intraoperative hypothermia under general anaesthesia especially in places where FAW system is unavailable.",2019,"Clinically relevant hypothermia (at least one measurement <35.5°C) was comparable between the two groups.
","['patients undergoing head and neck cancer surgeries', '80 American Society of Anesthesiologists Grade I/II adult patients admitted for head and neck cancer surgeries lasting more than 2 h under general anaesthesia were included']","['computer-generated codes to receive AA infusion', 'external heating (FAW system) and internal heat generation (AA infusion', 'normal saline at 3 mL/kg/h with FAW', 'Forced air warming (FAW', 'forced air warming and infusion of amino acid-enriched solution']","['baseline mean temperature', 'Clinically relevant hypothermia', 'intraoperative hypothermia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",80.0,0.0450235,"Clinically relevant hypothermia (at least one measurement <35.5°C) was comparable between the two groups.
","[{'ForeName': 'Nishkarsh', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS, Delhi, India.'}, {'ForeName': 'Sachidanand Jee', 'Initials': 'SJ', 'LastName': 'Bharti', 'Affiliation': 'Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS, Delhi, India.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS, Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS, Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS, Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH, AIIMS, Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_839_18']
1675,31572077,Comparison of efficacy of ultrasound-guided pectoral nerve block versus thoracic paravertebral block using levobupivacaine and dexamethasone for postoperative analgesia after modified radical mastectomy: A randomized controlled trial.,"Background and Aims
Pectoral nerve (PecS II) block is the latest modality for providing postoperative analgesia after breast surgery. The present study was planned to compare the analgesic efficacy of thoracic paravertebral block (TPVB) and PecS II for postoperative analgesia after modified radical mastectomy (MRM).
Methods
A total of 40 female patients undergoing radical mastectomy were randomly allocated into two groups ( n = 20). Group T received ultrasound-guided TPVB, while group P received PecS II block using 0.25% levobupivacaine 24 ml + dexamethasone 1 ml (4 mg) before induction of anesthesia. The primary outcome was duration of analgesia (time to request first analgesic dose), while total rescue analgesic consumption in first 24 h, numeric rating score (NRS), and complication were secondary outcomes. The data were analyzed using IBM SPSS software version 22.0.
Results
The duration of analgesia was significantly prolonged in the group P than group T (474.1 ± 84.93 versus 371.5 ± 51.53 min, respectively; P < 0.0001). Postoperative morphine consumed at 24 h was less in the group P than group T (11.25 ± 4.75 and 15.0 ± 4.86 mg, respectively; P = 0.018). NRS at movement and rest were lower in the group P as compared to group T at all time intervals (median 3 versus 4). No block-related complication was recorded in any group.
Conclusions
The 0.25% levobupivacaine with dexamethasone 4 mg in PecS II block provided longer duration of analgesia than the TPVB in patients undergoing MRM without any adverse effects.",2019,NRS at movement and rest were lower in the group P as compared to group T at all time intervals (median 3 versus 4).,"['40 female patients undergoing radical mastectomy', 'postoperative analgesia after modified radical mastectomy']","['thoracic paravertebral block (TPVB) and PecS II for postoperative analgesia after modified radical mastectomy (MRM', 'TPVB', 'levobupivacaine with dexamethasone', 'levobupivacaine and dexamethasone', 'Postoperative morphine', ' and Aims\n\n\nPectoral nerve (PecS II) block', 'ultrasound-guided pectoral nerve block', 'ultrasound-guided TPVB, while group P received PecS II block using 0.25% levobupivacaine 24 ml + dexamethasone']","['duration of analgesia (time to request first analgesic dose), while total rescue analgesic consumption in first 24 h, numeric rating score (NRS), and complication', 'duration of analgesia', 'block-related complication', 'longer duration of analgesia']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024884', 'cui_str': 'Mastectomy, Radical'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0024883', 'cui_str': 'Modified Mastectomy'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0024883', 'cui_str': 'Modified Mastectomy'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C4273496', 'cui_str': 'Modified PECS block'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}]",40.0,0.153886,NRS at movement and rest were lower in the group P as compared to group T at all time intervals (median 3 versus 4).,"[{'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Siddeshwara', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Singariya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Kumari', 'Affiliation': 'Government Medical College, Pali, Rajasthan, India.'}, {'ForeName': 'Satyanarayan', 'Initials': 'S', 'LastName': 'Seervi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_25_19']
1676,29628844,Dexmedetomidine in a surgically inserted catheter for transversus abdominis plane block in donor hepatectomy: A prospective randomized controlled study.,"Background
Transversus abdominis plane (TAP) block is a promising technique for analgesia after abdominal surgery. This prospective, randomized controlled trial assessed the effect of adding dexmedetomidine to bupivacaine in TAP block for donor hepatectomy. We hypothesized that this would improve postoperative morphine consumption and reduce analgesia related complication and inflammation.
Methods
A total of 50 donor hepatectomy were enrolled in this study. Patients divided into two equal groups according to drugs used for TAP block. Group (B) received 20 ml of bupivacaine hydrochloride 0.25%, Group (BD) received 20 ml of bupivacaine hydrochloride 0.25% and 0.3 μg/kg dexmedetomidine, on both sides at the end of surgery and every 8 h for 48 h at right side only through inserted catheter. Primary outcome objective was morphine consumption at first 72 h. Secondary outcome objectives were morphine requirement, numbers of intake, time to first intake, pain score numerical analog scale (NAS), postoperative analgesia related complications, recovery of intestinal motility, and inflammatory markers.
Results
Data were analyzed, rescue morphine analgesia was significantly lower in (BD) group compared with (B) groups as considering total morphine consumption (B 4 ± 1.9, BD 1.5 ± 0.5, P = 0.03), numbers of morphine intake ( P = 0.04), morphine requirement ( P = 0.03), and first time of analgesia intake ( P = 0.04). NAS was significantly lower in group (BD) compared with group (B) group in the first 12 h (NAS 0 - P = 0.001, NAS 1 - P = 0.03). Adding dexmedetomidine improved gut motility, first oral intake without detectable anti-inflammatory effect.
Conclusion
Adding dexmedetomidine to bupivacine in a surgically inserted catheter for TAP block in donor hepatectomy reduced morphine consumption without detectable anti-inflammatory effect.",2018,"NAS was significantly lower in group (BD) compared with group (B) group in the first 12 h (NAS 0 - P = 0.001, NAS 1 - P = 0.03).","['Methods\n\n\nA total of 50 donor hepatectomy', 'TAP block for donor hepatectomy', 'donor hepatectomy']","['Dexmedetomidine', 'bupivacaine', '\n\n\nTransversus abdominis plane (TAP) block', 'bupivacaine hydrochloride', 'dexmedetomidine', 'bupivacaine hydrochloride 0.25% and 0.3 μg/kg dexmedetomidine', 'TAP block']","['morphine consumption', 'rescue morphine analgesia', 'first time of analgesia intake', 'NAS', 'morphine requirement', 'gut motility, first oral intake without detectable anti-inflammatory effect', 'total morphine consumption', 'morphine requirement, numbers of intake, time to first intake, pain score numerical analog scale (NAS), postoperative analgesia related complications, recovery of intestinal motility, and inflammatory markers', 'numbers of morphine intake']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0411259', 'cui_str': 'Removal of liver from donor (procedure)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021838', 'cui_str': 'Intestinal Motility'}]",,0.224698,"NAS was significantly lower in group (BD) compared with group (B) group in the first 12 h (NAS 0 - P = 0.001, NAS 1 - P = 0.03).","[{'ForeName': 'Mohamed Adel', 'Initials': 'MA', 'LastName': 'Aboelela', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Al-Refaey', 'Initials': 'AR', 'LastName': 'Kandeel', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Usama', 'Initials': 'U', 'LastName': 'Elsayed', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elmorshedi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Elsarraf', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Elsayed', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elgawalby', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Sultan', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Mohamed Abdel', 'Initials': 'MA', 'LastName': 'Wahab', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Yassen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_577_17']
1677,31631058,Brain oscillation-synchronized stimulation of the left dorsolateral prefrontal cortex in depression using real-time EEG-triggered TMS.,"BACKGROUND
Repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (DLPFC) is an effective treatment for major depressive disorder (MDD), but response rates are low and effect sizes small. Synchronizing TMS pulses with instantaneous brain oscillations can reduce variability and increase efficacy of TMS-induced plasticity.
OBJECTIVE
To study whether brain oscillation-synchronized rTMS is feasible, safe and has neuromodulatory effects when targeting the DLPFC of patients with MDD.
METHODS
Using real-time EEG-triggered TMS we conducted a pseudo-randomized controlled single-session crossover trial of brain oscillation-synchronized rTMS of left DLPFC in 17 adult patients with antidepressant-resistant MDD. Stimulation conditions in separate sessions were: (1) rTMS triggered at the negative EEG peak of instantaneous alpha oscillations (alpha-synchronized rTMS), (2) a variation of intermittent theta-burst stimulation (modified iTBS), and (3) a random alpha phase control condition.
RESULTS
Triggering TMS at the negative peak of instantaneous alpha oscillations by real-time analysis of the electrode F5 EEG signal was successful in 15 subjects. Two subjects reported mild transient discomfort at the site of stimulation during stimulation; no serious adverse events were reported. Alpha-synchronized rTMS, but not modified iTBS or the random alpha phase control condition, reduced resting-state alpha activity in left DLPFC and increased TMS-induced beta oscillations over frontocentral channels.
CONCLUSIONS
Alpha-synchronized rTMS of left DLPFC is feasible, safe and has specific single-session neuromodulatory effects in patients with antidepressant-resistant MDD. Future studies need to further elucidate the mechanisms, optimize the parameters and investigate the therapeutic potential and efficacy of brain oscillation-synchronized rTMS in MDD.",2020,"Alpha-synchronized rTMS of left DLPFC is feasible, safe and has specific single-session neuromodulatory effects in patients with antidepressant-resistant MDD.","['patients with antidepressant-resistant MDD', 'patients with MDD', '17 adult patients with antidepressant-resistant MDD']","['Repetitive transcranial magnetic stimulation (rTMS', 'brain oscillation-synchronized rTMS of left DLPFC', 'real-time EEG-triggered TMS', 'brain oscillation-synchronized rTMS']","['serious adverse events', 'mild transient discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",17.0,0.0213004,"Alpha-synchronized rTMS of left DLPFC is feasible, safe and has specific single-session neuromodulatory effects in patients with antidepressant-resistant MDD.","[{'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology and Stroke, And Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology and Stroke, And Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen, Germany.'}, {'ForeName': 'Pedro Caldana', 'Initials': 'PC', 'LastName': 'Gordon', 'Affiliation': 'Department of Neurology and Stroke, And Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen, Germany; Service of Interdisciplinary Neuromodulation, Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Psychiatry (INBioN), Department and Institute of Psychiatry, Hospital Das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Belardinelli', 'Affiliation': 'Department of Neurology and Stroke, And Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen, Germany.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'McDermott', 'Affiliation': 'Department of Neurology and Stroke, And Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen, Germany.'}, {'ForeName': 'Surjo R', 'Initials': 'SR', 'LastName': 'Soekadar', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Eberhard Karls University Tübingen, Germany; Clinical Neurotechnology Laboratory, Neuroscience Research Center (NWFZ) & Department of Psychiatry and Psychotherapy, Charité - University Medicine Berlin, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Eberhard Karls University Tübingen, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology and Stroke, And Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen, Germany. Electronic address: ulf.ziemann@uni-tuebingen.de.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Müller-Dahlhaus', 'Affiliation': 'Department of Neurology and Stroke, And Hertie Institute for Clinical Brain Research, Eberhard Karls University Tübingen, Germany; Department of Psychiatry and Psychotherapy, Johannes Gutenberg University Medical Center Mainz, Germany.'}]",Brain stimulation,['10.1016/j.brs.2019.10.007']
1678,29416453,Effect of dexmedetomidine on emergence agitation using desflurane in pediatric cataract surgery.,"Background
In this study, we compared effectiveness of two doses of dexmedetomidine (0.15 μg/kg and 0.3 μg/kg) in preventing desflurane-induced emergence agitation (EA) in pediatric patients undergoing elective cataract surgery.
Methods
It is a prospective double-blinded randomized study conducted on 65 American Society of Anesthesiologists 1 children (2-10 years) who underwent elective cataract surgery at our institute. They were randomized into two equal groups, who received either dexmedetomidine 0.15 μg/kg (Group D 0.15 ) or dexmedetomidine 0.30 μg/kg (Group D 0.3 ) intravenously after induction of anesthesia. An observer blinded to groups recorded heart rate (HR), arterial blood pressure, oxygen saturation, end-tidal carbon dioxide, and respiratory rate (RR) at regular intervals and evaluated preoperative anxiety, state of agitation, and postoperative pain using validated scores.
Results
Both groups (Group D 0.15 , n = 27 vs. Group D 0.3 , n = 26) were demographically identical. In intraoperative period, the difference in HRs was significantly lower in Group D 0 . 3 from 5 min till 15 min of the surgery ( P < 0.05), but thereafter, from 20 min till end of surgery, the rates were comparable in both the groups, whereas RR and blood pressure fluctuations were comparable throughout. Postoperative pain scores and postoperative agitation score were significantly lower in Group D 0.3 than D 0.15 at all time intervals ( P < 0.05).
Conclusions
In our study, 0.3 μg/kg intravenous dexmedetomidine was found to be superior to 0.15 μg/kg group in effectively reducing EA and postoperative pain, without producing adverse effects such as hypotension or bradycardia.",2018,"Postoperative pain scores and postoperative agitation score were significantly lower in Group D 0.3 than D 0.15 at all time intervals ( P < 0.05).
","['pediatric patients undergoing elective cataract surgery', '65 American Society of Anesthesiologists 1 children (2-10 years) who underwent elective cataract surgery at our institute', 'pediatric cataract surgery']","['desflurane', 'dexmedetomidine', 'desflurane-induced emergence agitation (EA']","['HRs', 'hypotension or bradycardia', 'EA and postoperative pain', 'RR and blood pressure fluctuations', 'Postoperative pain scores and postoperative agitation score', 'heart rate (HR), arterial blood pressure, oxygen saturation, end-tidal carbon dioxide, and respiratory rate (RR) at regular intervals and evaluated preoperative anxiety, state of agitation, and postoperative pain using validated scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0549405', 'cui_str': 'Blood pressure fluctuation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}]",65.0,0.37535,"Postoperative pain scores and postoperative agitation score were significantly lower in Group D 0.3 than D 0.15 at all time intervals ( P < 0.05).
","[{'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesia, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Babita', 'Initials': 'B', 'LastName': 'Ghai', 'Affiliation': 'Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Jagat', 'Initials': 'J', 'LastName': 'Ram', 'Affiliation': 'Department of Ophthalmology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_235_17']
1679,29416454,A randomized controlled trial comparing C Mac D Blade and Macintosh laryngoscope for nasotracheal intubation in patients undergoing surgeries for head and neck cancer.,"Purpose
Several devices are available to take care of difficult airway, but C-MAC D-Blade has scant evidence of its use in nasotracheal intubation in a difficult airway scenario.
Aims and Objectives
We compared the C-MAC D-Blade videolaryngoscope ™ , and the standard Macintosh laryngoscope for nasal intubation in patients with difficult airways selected by El-Ganzouri risk index using parameters of time and attempts required for intubation, glottic view in terms of Cormack-Lehane grade, ease of intubation, success rate, use of accessory maneuvers, incidence of complications, and hemodynamic changes.
Methods
One hundred American Society of Anesthesiologists (ASA) I-III patients aged 20-70 years with EGRI score 1-≤7 scheduled for head and neck surgery requiring nasal intubation. ASA IV patients, patients with mouth opening <2.5 cm, patients difficult to mask ventilate, and patients with hyperkalemia and history of malignant hyperthermia were excluded from the study. Primary outcome was time taken to intubation, and secondary outcomes were a number of attempts, glottic view in terms of C/L grade, use of accessory maneuvers, success rate, incidence of trauma, ease of intubation, and hemodynamic changes before and after intubation.
Results
Time required for intubation was less (39.56 ± 15.65 s) in Group C than in Group M (50.34 ± 15.65 s). Cormack-Lehane Grade I and II view were more in C-MAC D-Blade group ( P < 0.05). Success rate and ease of intubation were found to be more in C-MAC D-Blade group than in Macintosh group ( P < 0.05). A number of attempts and incidence of complications such as trauma, bleeding, and failed intubation were greater in Macintosh group than in C-MAC D-Blade group. Hemodynamic changes were observed to be comparable in both the groups.
Conclusion
C-MAC D-Blade videolaryngoscope ™ is a better tool in anesthetic management of difficult airway for nasal intubation compared to conventional Macintosh laryngoscope.",2018,"A number of attempts and incidence of complications such as trauma, bleeding, and failed intubation were greater in Macintosh group than in C-MAC D-Blade group.","['patients with difficult airways selected by El-Ganzouri risk index', 'ASA IV patients, patients with mouth opening <2.5 cm, patients difficult to mask ventilate, and patients with hyperkalemia and history of malignant hyperthermia', 'hundred American Society of Anesthesiologists (ASA', 'I-III patients aged 20-70 years with EGRI score 1-≤7 scheduled for head and neck surgery requiring nasal intubation', 'patients undergoing surgeries for head and neck cancer']","['C-MAC D-Blade videolaryngoscope ™ , and the standard Macintosh laryngoscope', 'C Mac D Blade and Macintosh laryngoscope']","['Success rate and ease of intubation', 'Results\n\n\nTime required for intubation', 'Hemodynamic changes', 'Cormack-Lehane Grade', 'time taken to intubation, and secondary outcomes were a number of attempts, glottic view in terms of C/L grade, use of accessory maneuvers, success rate, incidence of trauma, ease of intubation, and hemodynamic changes before and after intubation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0024591', 'cui_str': 'Anesthesia Related Hyperthermia'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0185773', 'cui_str': 'Operation on neck'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]",100.0,0.0834679,"A number of attempts and incidence of complications such as trauma, bleeding, and failed intubation were greater in Macintosh group than in C-MAC D-Blade group.","[{'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Hazarika', 'Affiliation': 'Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research Centre, Sector V, Rohini, New Delhi, India.'}, {'ForeName': 'Anudeep', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research Centre, Sector V, Rohini, New Delhi, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research Centre, Sector V, Rohini, New Delhi, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Kumar Bhargava', 'Affiliation': 'Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research Centre, Sector V, Rohini, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_239_17']
1680,29416458,Randomized comparison between dexmedetomidine and midazolam for prevention of emergence agitation after nasal surgeries.,"Background
Emergence agitation (EA) in nasal surgeries is seen in around 22% of patients, which can go to dangerous levels. Dexmedetomidine is effective in prevention of EA in such patients. Midazolam given as premedication fails to prevent EA due to its short half-life. In this study, we compared efficacy of dexmedetomidine and midazolam by intravenous infusion for prevention of EA in adult nasal surgeries.
Materials and Methods
Seventy patients belonging to American society of anesthesiologist Status I and II, between 18 and 60 years of age posted for elective nasal surgeries were randomly divided into two groups. Group D received intravenous dexmedetomidine 0.5 mcg/kg over 15 min followed by 0.1 mcg/kg/h. Group M received intravenous midazolam 0.02 mg/kg over 15 min followed by 0.02 mg/kg/h. EA scores, emergence times, and hemodynamic parameters were monitored and compared between the groups. Statistical analysis was done by independent t -test, Mann-Whitney U-test, and Chi-square test as applicable.
Results
Incidence of EA was comparable between the groups ( P = 0.23). Two patients in midazolam group developed dangerous agitation while none in dexmedetomidine group. Patients in midazolam group (12.4%) were agitated even in postoperative period, which was not seen with dexmedetomidine group. Hypotension and bradycardia were seen more in dexmedetomidine group.
Conclusion
Efficacy of midazolam when given as an intravenous infusion is comparable to dexmedetomidine in prevention of EA in nasal surgeries.",2018,Incidence of EA was comparable between the groups ( P = 0.23).,"['adult nasal surgeries', 'emergence agitation after nasal surgeries', 'Seventy patients belonging to American society of anesthesiologist Status I and II, between 18 and 60 years of age posted for elective nasal surgeries']","['Dexmedetomidine', 'midazolam', 'intravenous dexmedetomidine', 'dexmedetomidine and midazolam', '\n\n\nEmergence agitation (EA', 'dexmedetomidine', 'Midazolam']","['Hypotension and bradycardia', 'dangerous agitation', 'Incidence of EA', 'EA scores, emergence times, and hemodynamic parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0188970', 'cui_str': 'Rhinosurgery'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",70.0,0.123085,Incidence of EA was comparable between the groups ( P = 0.23).,"[{'ForeName': 'Pranjali', 'Initials': 'P', 'LastName': 'Kurhekar', 'Affiliation': 'Department of Anesthesiology, Shri Sathya Sai Medical College and Research Institute, Kancheepuram, India.'}, {'ForeName': 'Krishnagopal', 'Initials': 'K', 'LastName': 'Vinod', 'Affiliation': 'Department of Pain Medicine, Shri Sathya Sai Medical College and Research Institute, Kancheepuram, India.'}, {'ForeName': 'Buddhan', 'Initials': 'B', 'LastName': 'Rajarathinam', 'Affiliation': 'Fortis Malar Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'J Shesha', 'Initials': 'JS', 'LastName': 'Dhiviya Krishna', 'Affiliation': 'Department of Anesthesiology, Shri Sathya Sai Medical College and Research Institute, Kancheepuram, India.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Anesthesiology, Shri Sathya Sai Medical College and Research Institute, Kancheepuram, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_419_17']
1681,29416460,Endotrol tracheal tube and McGrath Mac are an effective combination for oral tracheal intubation.,"Background
Tracheal intubation using the 2 nd -generation video laryngoscope sometimes cannot be performed easily because there is no functional endotracheal tube (ETT) guide. Therefore, a rigid stylet is often required during tracheal intubation. The Endotrol ® tracheal tube (Endotrol) is a single use ETT that whole tube can be bent and slide easily into the trachea. We studied the intubation ease of a combination of an Endtrol and the McGrath ® video laryngoscope (McGrath), which is one of the 2 nd -generation video laryngoscopes.
Methods
Sixty adult patients under general anesthesia were randomized into three groups: Group A: McGrath with Endotrol, B: McGrath with a rigid stylet attached ETT, and C: Direct laryngoscope with an ETT. The primary outcome measure was intubation time. Secondary outcomes were the number of insertion attempts required and the number of patients who complained of a sore throat after the procedure. The level of significance for each test was set at P < 0.05.
Results
Intubation time (median [range] in seconds) was shorter in Group A (32 [27-54]) than Group B (37 [27-49]) and C (37 [27-50]) ( P = 0.01 for both comparison). There was no significant difference among groups for the number of insertion attempts required. The number of patients with a sore throat was lower in Group A (0) than Group B (5) and C (6) ( P = 0.02 and 0.01, respectively).
Conclusion
A combination of an Endtrol and a McGrath is effective for shortening intubation time and avoiding sore throats.",2018,"The number of patients with a sore throat was lower in Group A (0) than Group B (5) and C (6) ( P = 0.02 and 0.01, respectively).
",['Sixty adult patients under general anesthesia'],"['Endtrol and the McGrath ® video laryngoscope (McGrath', 'McGrath with Endotrol, B: McGrath with a rigid stylet attached ETT, and C: Direct laryngoscope with an ETT', 'Endtrol and a McGrath', 'Endotrol tracheal tube and McGrath Mac']","['Intubation time', 'intubation time', 'shortening intubation time and avoiding sore throats', 'number of patients with a sore throat', 'number of insertion attempts required and the number of patients who complained of a sore throat']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0183663', 'cui_str': 'Stylet, device (physical object)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube (physical object)'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",60.0,0.102334,"The number of patients with a sore throat was lower in Group A (0) than Group B (5) and C (6) ( P = 0.02 and 0.01, respectively).
","[{'ForeName': 'Azusa', 'Initials': 'A', 'LastName': 'Shimazaki', 'Affiliation': 'Department of Anaesthesiology, Showa University Hospital, 1-5-8 Hatanodai Shinagawa-ku, 142-8666 Tokyo, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Ueshima', 'Affiliation': 'Department of Anaesthesiology, Showa University Hospital, 1-5-8 Hatanodai Shinagawa-ku, 142-8666 Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': 'Department of Anaesthesiology, Showa University Hospital, 1-5-8 Hatanodai Shinagawa-ku, 142-8666 Tokyo, Japan.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_301_17']
1682,31628019,Assessing barriers and increasing use of immunization information systems in independent community pharmacies: Study protocol for a randomized controlled trial.,"BACKGROUND
As the number of providers administering vaccines increases, including pharmacists, there is a concern of fragmented immunization records in state and regional immunization information systems (IIS). In order for IIS to have complete records, it is critical that each provider administering vaccines, including pharmacists, participate and update the IIS each time a vaccine is administered to a patient. In Alabama, provider participation in the state IIS is not mandatory; as a result, less than 25% of adults over the age of 19 have immunization data recorded. IIS participation among independent pharmacies is of particular concern as approximately 40% of Alabama pharmacies are independently owned, but only 27% of these are enrolled in the IIS.
OBJECTIVE
The objective of this report is to describe a study protocol to assess the impact of an IIS training program among community pharmacies' IIS enrollment and actual participation rates.
METHODS
The research design is a randomized controlled trial. Study participants are Alabama pharmacists who work in independently owned pharmacies that currently provide at least one type of non-seasonal vaccine and are not currently enrolled in the Alabama IIS. Multiple outcomes including awareness, knowledge, attitudes, intention, IIS enrollment, and IIS participation will be compared between intervention and control groups across three time points (baseline, one-month, and three-months). Individual and organizational factors will be measured to identify any possible associations with outcomes.
IMPLICATIONS
The expected outcome is to create an effective training program that is scalable and ready for dissemination. If successful, this training program can be replicated and used to significantly impact the completeness and accuracy of IIS across the U.S., providing the potential for IIS to be used consistently in assessing immunization status and recommending additional vaccines in the pharmacy setting, thereby improving vaccination coverage and making the provision of immunizations safe and efficient.",2020,"If successful, this training program can be replicated and used to significantly impact the completeness and accuracy of IIS across the U.S., providing the potential for IIS to be used consistently in assessing immunization status and recommending additional vaccines in the pharmacy setting, thereby improving vaccination coverage and making the provision of immunizations safe and efficient.","['independent community pharmacies', 'Study participants are Alabama pharmacists who work in independently owned pharmacies that currently provide at least one type of non-seasonal vaccine and are not currently enrolled in the Alabama IIS']",['IIS training program'],"['awareness, knowledge, attitudes, intention, IIS enrollment, and IIS participation']","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0521113', 'cui_str': 'Non-seasonal (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0555944,"If successful, this training program can be replicated and used to significantly impact the completeness and accuracy of IIS across the U.S., providing the potential for IIS to be used consistently in assessing immunization status and recommending additional vaccines in the pharmacy setting, thereby improving vaccination coverage and making the provision of immunizations safe and efficient.","[{'ForeName': 'Tessa J', 'Initials': 'TJ', 'LastName': 'Hastings', 'Affiliation': 'University of South Carolina College of Pharmacy, Department of Clinical Pharmacy and Outcomes Sciences, 715 Sumter Street, Columbia, 29208, SC, USA. Electronic address: hastint@mailbox.sc.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ha', 'Affiliation': 'Stanford Health Care, 300 Pasteur Drive, Stanford, 94305, CA, USA. Electronic address: davidrossha@gmail.com.'}, {'ForeName': 'Brent I', 'Initials': 'BI', 'LastName': 'Fox', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 4306 Walker Building, Auburn, 36849, AL, USA. Electronic address: foxbren@auburn.edu.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 4306 Walker Building, Auburn, 36849, AL, USA. Electronic address: jzq0004@auburn.edu.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Lakin', 'Affiliation': 'Auburn University College of Education, Department of Educational Foundations, Leadership, and Technology, 4072 Haley Center, Auburn, 36849, AL, USA. Electronic address: jml0035@auburn.edu.'}, {'ForeName': 'Salisa C', 'Initials': 'SC', 'LastName': 'Westrick', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 4306 Walker Building, Auburn, 36849, AL, USA. Electronic address: westrsc@auburn.edu.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.10.007']
1683,31552704,Aerobic training session length affects arterial elasticity.,"PURPOSE
The purpose of this study was to examine haemodynamic and arterial elasticity responses to aerobic exercise of varying durations.
METHODS
Eighteen male subjects (age = 23·4 ± 2·0) performed a maximal aerobic fitness (VO 2max ) test. Participants met in the laboratory following an overnight fast for three randomly assigned sessions. Assessments for large and small arterial elasticity (SAE), systemic vascular resistance (SVR), total vascular impedance (TVI), systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), stroke volume (SV), cardiac output (CO), pulse pressure (PP) and cardiac ejection time (CET) were performed using applanation tonometry at the radial artery. Following baseline measurements, participants executed aerobic exercise on a treadmill at 65% of their respective VO 2max for 30, 45 or 60 min on three different occasions. Postexercise measurements were performed immediately, 10, 20 and 40 min postexercise cessation.
RESULTS
The 60-min exercise bout resulted in significantly increased SAE values (P < 0·04) and decreased SVR values (P < 0·02) when compared with the 30-min exercise bout. The 60-min session also caused significantly higher HR values and significantly lower values for SV and DBP values following exercise (P < 0·04).
CONCLUSIONS
The results of this study emphasize that varying the length of moderate-intensity aerobic exercise bouts affects arterial elasticity response and total vascular resistance.",2020,The 60-min exercise bout resulted in significantly increased SAE values (p<0.04) and decreased SVR values (p<0.02) when compared with the 30-min exercise bout.,['Eighteen male subjects (age= 23.4±2.0'],"['maximal aerobic fitness (VO 2max ) test', 'aerobic exercise of varying durations', 'aerobic exercise']","['SVR values', 'SAE values', 'arterial elasticity response and total vascular resistance', 'SV and DBP values', 'large and small arterial elasticity (SAE), systemic vascular resistance (SVR), total vascular impedance (TVI), systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), stroke volume (SV), cardiac output (CO), pulse pressure (PP), and cardiac ejection time (CET', 'higher HR values']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0013764'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429119', 'cui_str': 'Vascular resistance (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0232351', 'cui_str': 'Vascular impedance (observable entity)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",18.0,0.188145,The 60-min exercise bout resulted in significantly increased SAE values (p<0.04) and decreased SVR values (p<0.02) when compared with the 30-min exercise bout.,"[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Karabulut', 'Affiliation': 'University of Texas Rio Grande Valley, Brownsville, TX, USA.'}, {'ForeName': 'Joe A', 'Initials': 'JA', 'LastName': 'Lopez', 'Affiliation': 'University of Texas Rio Grande Valley, Brownsville, TX, USA.'}, {'ForeName': 'Ulku', 'Initials': 'U', 'LastName': 'Karabulut', 'Affiliation': 'University of Texas Rio Grande Valley, Brownsville, TX, USA.'}]",Clinical physiology and functional imaging,['10.1111/cpf.12596']
1684,31572071,Comparative study of fiber-optic guided tracheal intubation through intubating laryngeal mask airway LMA Fastrach™ and i-gel in adult paralyzed patients.,"Background
The i-gel is a novel and innovative supraglottic airway management device used both as an airway rescue device and as a conduit for fiberoptic intubation. In this prospective randomized study, we compared fiberoptic-guided tracheal intubation through the i-gel and LMA Fastrach™ in adult paralyzed patients.
Materials and Methods
After ethical committee approval and written informed consent, 60 patients of either sex were randomly allocated to either group of supraglottic airway device (SGAD). After successful insertion of the SGAD, the fiberoptic bronchoscope (FOB)-guided tracheal intubation was done through the respective SGAD. The primary objectives were the ease and time taken for fiberoptic-guided intubation in either group. Secondary variables included time taken for successful placement of SGAD, ease of insertion of SGAD, airway seal pressure, ease and time of removal of SGAD, variation in hemodynamic parameters, and complications if any.
Results
Time taken for tracheal intubation in LMA Fastrach™ group was 69.53 ± 5.09 s and for the i-gel group it was 72.33 ± 6.73 s. It was seen that it was easy to insert the endotracheal tube (ETT) in 93.3% patients in the LMA Fastrach™ group and 96.7% patients in the i-gel group. Airway seal pressure was higher for the LMA Fastrach™ group. Both the SGADs were comparable in the number of attempts of insertion, ease of insertion, and insertion time. In addition, the hemodynamic variables noted did not show any increase after insertion of SGAD. There was no difficulty encountered in removal of either SGAD.
Conclusion
I-gel may be a reliable and cost-effective alternative to LMA Fastrach™ for fibreoptic-guided tracheal intubation.",2019,"Conclusion
I-gel may be a reliable and cost-effective alternative to LMA Fastrach™ for fibreoptic-guided tracheal intubation.","['60 patients of either sex', 'adult paralyzed patients']","['fiberoptic-guided tracheal intubation through the i-gel and LMA Fastrach', 'fiberoptic bronchoscope (FOB)-guided tracheal intubation', 'fiber-optic guided tracheal intubation through intubating laryngeal mask airway LMA Fastrach™ and i-gel', 'supraglottic airway device (SGAD']","['Airway seal pressure', 'removal of either SGAD', 'number of attempts of insertion, ease of insertion, and insertion time', 'time taken for successful placement of SGAD, ease of insertion of SGAD, airway seal pressure, ease and time of removal of SGAD, variation in hemodynamic parameters, and complications if any', 'ease and time taken for fiberoptic-guided intubation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope (physical object)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C1275745', 'cui_str': 'Intubating laryngeal mask airway'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",60.0,0.0684664,"Conclusion
I-gel may be a reliable and cost-effective alternative to LMA Fastrach™ for fibreoptic-guided tracheal intubation.","[{'ForeName': 'Suvidha', 'Initials': 'S', 'LastName': 'Sood', 'Affiliation': 'Department of Anaesthesiology, ESI-PGIMSR, Basaidarapur, New Delhi, India.'}, {'ForeName': 'Anupriya', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Anaesthesiology, ESI-PGIMSR, Basaidarapur, New Delhi, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'Department of Anaesthesiology, ESI-PGIMSR, Basaidarapur, New Delhi, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Chahar', 'Affiliation': 'Department of Anaesthesiology, ESI-PGIMSR, Basaidarapur, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_707_18']
1685,31572072,Comparison of ultrasound-guided versus conventional palpatory method of dorsalis pedis artery cannulation: A randomized controlled trial.,"Background
Whether use of ultrasound (USG) to cannulate dorsalis pedis artery (DPA) increases first pass successful cannulation, decreases the number of attempts and complications as compared to palpation technique was assessed in this study.
Design
Randomized controlled trial.
Setting
Operating room.
Patients
About 60 adult patients undergoing any head-neck or faciomaxillary surgery requiring arterial cannulation were enrolled.
Intervention
DPA was cannulated either by USG-guided technique (USG group) or by palpation technique (palpation group) with 30 patients in each group.
Measurement
Data were assessed for ""first-attempt success"" of cannulation, number of attempts, assessment time, cannulation time, cannulation failure, and incidence of complications.
Main Results
Successful first pass DPA cannulation was similar between the groups (ultrasound group vs. palpation group, 76.7% vs. 60%, respectively) [relative risk (95% confidence interval (CI) = 0.69 (0.43, 1.13), P = 0.267)] as was the number of attempts required for successful cannulation [median (interquartile range (IQR) number of attempts 1 (1-2) in palpation group P and USG group U 1 (1-1); P = 0.376]. Median (IQR) assessment time was significantly less ( P < 0.0004) in palpation group [palpation group 12 (9-17) vs. USG group U 19 (15-21)]. However, cannulation time was significantly higher ( P = 0.0093) in Group P [median (IQR) 17.5 (12-36 s) and 11.5 (9-15)]. Although the total procedure time (sum of both assessment time and cannulation time) remain statistically similar between two groups ( P = 0.8882).
Conclusions
Use of USG for the cannulation of DPA is feasible, but it is not associated with significant increase in first-attempt success rate, decrease in total number of cannulation attempts or total procedure time.",2019,Median (IQR) assessment time was significantly less ( P < 0.0004) in palpation group [palpation group 12 (9-17) vs. USG group U 19 (15-21)].,"['Patients', '60 adult patients undergoing any head-neck or faciomaxillary surgery requiring arterial cannulation were enrolled']","['ultrasound-guided versus conventional palpatory method of dorsalis pedis artery cannulation', 'USG-guided technique (USG group) or by palpation technique (palpation group) with 30 patients in each group', 'ultrasound (USG']","['total procedure time', 'total number of cannulation attempts or total procedure time', 'first-attempt success"" of cannulation, number of attempts, assessment time, cannulation time, cannulation failure, and incidence of complications', 'Median (IQR) assessment time', 'cannulation time', 'Successful first pass DPA cannulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0007431', 'cui_str': 'Arterial cannula insertion (procedure)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0226492', 'cui_str': 'Structure of dorsalis pedis artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}]",60.0,0.107789,Median (IQR) assessment time was significantly less ( P < 0.0004) in palpation group [palpation group 12 (9-17) vs. USG group U 19 (15-21)].,"[{'ForeName': 'Rahul Kumar', 'Initials': 'RK', 'LastName': 'Anand', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Maitra', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India.'}, {'ForeName': 'Bikas Ranjan', 'Initials': 'BR', 'LastName': 'Ray', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India.'}, {'ForeName': 'Dalim Kumar', 'Initials': 'DK', 'LastName': 'Baidhya', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Khanna', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India.'}, {'ForeName': 'Sumit Roy', 'Initials': 'SR', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_766_18']
1686,31588356,"Protocol for the electroencephalography guidance of anesthesia to alleviate geriatric syndromes (ENGAGES-Canada) study: A pragmatic, randomized clinical trial.","Background: There is some evidence that electroencephalography guidance of general anesthesia can decrease postoperative delirium after non-cardiac surgery. There is limited evidence in this regard for cardiac surgery. A suppressed electroencephalogram pattern, occurring with deep anesthesia, is associated with increased incidence of postoperative delirium (POD) and death. However, it is not yet clear whether this electroencephalographic pattern reflects an underlying vulnerability associated with increased incidence of delirium and mortality, or whether it is a modifiable risk factor for these adverse outcomes. Methods: The E lectroe n cephalography G uidance of A nesthesia to Alleviate Ge riatric S yndromes ( ENGAGES-Canada ) is an ongoing pragmatic 1200 patient trial at four Canadian sites. The study compares the effect of two anesthetic management approaches on the incidence of POD after cardiac surgery. One approach is based on current standard anesthetic practice and the other on electroencephalography guidance to reduce POD. In the guided arm, clinicians are encouraged to decrease anesthetic administration, primarily if there is electroencephalogram suppression and secondarily if the EEG index is lower than the manufacturers recommended value (bispectral index (BIS) or WAVcns below 40 or Patient State Index below 25). The aim in the guided group is to administer the minimum concentration of anesthetic considered safe for individual patients. The primary outcome of the study is the incidence of POD, detected using the confusion assessment method or the confusion assessment method for the intensive care unit; coupled with structured delirium chart review. Secondary outcomes include unexpected intraoperative movement, awareness, length of intensive care unit and hospital stay, delirium severity and duration, quality of life, falls, and predictors and outcomes of perioperative distress and dissociation. Discussion: The ENGAGES-Canada trial will help to clarify whether or not using the electroencephalogram to guide anesthetic administration during cardiac surgery decreases the incidence, severity, and duration of POD. Registration: ClinicalTrials.gov ( NCT02692300) 26/02/2016.",2019,"A suppressed electroencephalogram pattern, occurring with deep anesthesia, is associated with increased incidence of postoperative delirium (POD) and death. ","['geriatric syndromes', '1200 patient trial at four Canadian sites']",[],"['unexpected intraoperative movement, awareness, length of intensive care unit and hospital stay, delirium severity and duration, quality of life, falls, and predictors and outcomes of perioperative distress and dissociation', 'incidence of POD, detected using the confusion assessment method or the confusion assessment method for the intensive care unit; coupled with structured delirium chart review', 'postoperative delirium', 'postoperative delirium (POD) and death']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034380'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0086168', 'cui_str': 'Dissociation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.167213,"A suppressed electroencephalogram pattern, occurring with deep anesthesia, is associated with increased incidence of postoperative delirium (POD) and death. ","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Deschamps', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Montreal Heart Institute and Universite de Montreal, Montreal, Quebec, H1T 1C8, Canada.'}, {'ForeName': 'Tarit', 'Initials': 'T', 'LastName': 'Saha', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Queen's University, Kingston, Kingston, Ontario, Canada.""}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'El-Gabalawy', 'Affiliation': 'Department of Clinical Health Psychology, Anesthesiology, Perioperative and Pain Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': 'Departments of Anesthesia and Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Overbeek', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Palermo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Robichaud', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, H1T 1C8, Canada.'}, {'ForeName': 'Andrea Alicia', 'Initials': 'AA', 'LastName': 'Dumont', 'Affiliation': 'Montreal Health Innovation Coordinating Center, Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Djaiani', 'Affiliation': 'Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Morvarid S', 'Initials': 'MS', 'LastName': 'Kavosh', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Tanzola', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Queen's University, Kingston, Kingston, Ontario, Canada.""}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Schmitt', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachussetts, USA.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachussetts, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Oberhaus', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St-Louis, Missouri, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mickle', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St-Louis, Missouri, USA.'}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St-Louis, Missouri, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St-Louis, Missouri, USA.'}, {'ForeName': 'Canadian Perioperative Anesthesia', 'Initials': 'CPA', 'LastName': 'Clinical Trials Group', 'Affiliation': 'Department of Anesthesia, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",F1000Research,['10.12688/f1000research.19213.1']
1687,31410514,Comparison Between the Protector™ Laryngeal Mask Airway and the Endotracheal Tube for Minimally Invasive Thyroid and Parathyroid Surgery.,"BACKGROUND
Pharyngolaryngeal symptoms are a main concern after neck surgery. The Protector™ LMA is a new supraglottic airway device. The main purpose of this study was to evaluate whether application of the LMA Protector™ causes fewer pharyngolaryngeal symptoms than application of the endotracheal tube after minimally invasive total thyroidectomy and parathyroidectomy.
METHODS
This prospective, randomized controlled trial involved one university and one private practice clinic, during the period from January 2017 until November 2017. The patients were randomly allocated to two groups: ETT and LMA. Main outcomes were Numerical Rating Scale scores of postoperative dysphagia, pharyngodynia, and incisional pain. Secondary outcomes were the frequency of rescue analgesia (paracetamol) consumption and emergence cough. Data were recorded in the post-anesthesia care unit and at 1, 6, 12, and 24 h after surgery.
RESULTS
Data from 78 patients were included in the final analysis. Pharyngodynia scores were significantly lower in the LMA group, compared with the ETT group, at 1 h, 6 h and 12 h after surgery. Dysphagia and surgical incision pain scores were also significantly lower in the LMA group, compared with the ETT group, at 6 h and 12 h after surgery. The frequency of postoperative paracetamol consumption was significantly increased in the ETT group, compared with the LMA group. Finally, the LMA group had fewer episodes of emergence cough, compared with the ETT group.
CONCLUSION
The LMA Protector™ causes fewer pharyngolaryngeal symptoms than the ETT within 6 and 12 h after minimally invasive total thyroidectomy and parathyroidectomy.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT03098667.",2019,"The frequency of postoperative paracetamol consumption was significantly increased in the ETT group, compared with the LMA group.","['one university and one private practice clinic, during the period from January 2017 until November 2017', '78 patients were included in the final analysis']","['LMA Protector', 'Protector™ Laryngeal Mask Airway and the Endotracheal Tube', 'ETT and LMA', 'LMA']","['frequency of rescue analgesia (paracetamol) consumption and emergence cough', 'pharyngolaryngeal symptoms', 'Dysphagia and surgical incision pain scores', 'episodes of emergence cough', 'Numerical Rating Scale scores of postoperative dysphagia, pharyngodynia, and incisional pain', 'Pharyngodynia scores', 'frequency of postoperative paracetamol consumption']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3854543', 'cui_str': 'Pharyngodynia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]",,0.106549,"The frequency of postoperative paracetamol consumption was significantly increased in the ETT group, compared with the LMA group.","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Kotsovolis', 'Affiliation': 'Department of Anesthesia, 424 Army General Hospital, Thessaloniki, Greece. gskotsos@gmail.com.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Pliakos', 'Affiliation': '1st Propedeutic Department of Surgery, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Panidis', 'Affiliation': '1st Propedeutic Department of Surgery, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Gkinas', 'Affiliation': 'Department of Anesthesia and Intensive Care, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Theodosios', 'Initials': 'T', 'LastName': 'Papavramidis', 'Affiliation': '1st Propedeutic Department of Surgery, AHEPA University Hospital, Thessaloniki, Greece.'}]",World journal of surgery,['10.1007/s00268-019-05122-8']
1688,31487546,Community Health Workers Improve Linkage to Hypertension Care in Western Kenya.,"BACKGROUND
Elevated blood pressure (BP) is the leading global risk factor for mortality. Delay in seeking hypertension care is associated with increased mortality.
OBJECTIVES
This study investigated whether community health workers, equipped with behavioral communication strategies and smartphone technology, can increase linkage of individuals with elevated BP to a hypertension care program in western Kenya and significantly reduce BP.
METHODS
The study was a cluster randomized trial with 3 arms: 1) usual care (standard training); 2) ""paper-based"" (tailored behavioral communication, using paper-based tools); and 3) ""smartphone"" (tailored behavioral communication, using smartphone technology). The co-primary outcomes were: 1) linkage to care; and 2) change in systolic BP (SBP). A covariate-adjusted mixed-effects model was used, adjusting for differential time to follow-up. Bootstrap and multiple imputation were used to handle missing data.
RESULTS
A total of 1,460 individuals (58% women) were enrolled (491 usual care, 500 paper-based, 469 smartphone). Average baseline SBP was 159.4 mm Hg. Follow-up measures of linkage were available for 1,128 (77%) and BP for 1,106 (76%). Linkage to care was 49% overall, with significantly greater linkage in the usual care and smartphone arms of the trial. Average overall follow-up SBP was 149.9 mm Hg. Participants in the smartphone arm experienced a modestly greater reduction in SBP versus usual care (-13.1 mm Hg vs. -9.7 mm Hg), but this difference was not statistically significant. Mediation analysis revealed that linkage to care contributed to SBP change.
CONCLUSIONS
A strategy combining tailored behavioral communication and mobile health (mHealth) for community health workers led to improved linkage to care, but not statistically significant improvement in SBP reduction. Further innovations to improve hypertension control are needed. (Optimizing Linkage and Retention to Hypertension Care in Rural Kenya [LARK]; NCT01844596).",2019,"Participants in the smartphone arm experienced a modestly greater reduction in SBP vs. usual care (-13.1 mmHg vs. -9.7), but this difference was not statistically significant.","['individuals with elevated BP to a hypertension care program in western Kenya and significantly reduce BP', 'Community Health Workers Improve Linkage to Hypertension Care in Western Kenya', '1460 individuals (58% women) were enrolled (491 usual care, 500 paper-based, 469 smartphone', 'community health workers']","['usual care (standard training); 2) ""paper-based"" (tailored behavioral communication, using paper-based tools); and 3) ""smartphone"" (tailored behavioral communication, using smartphone technology']","['SBP reduction', 'SBP vs. usual care', '1) linkage to care, and 2) change in systolic BP (SBP']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",469.0,0.0333161,"Participants in the smartphone arm experienced a modestly greater reduction in SBP vs. usual care (-13.1 mmHg vs. -9.7), but this difference was not statistically significant.","[{'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Vedanthan', 'Affiliation': 'New York University School of Medicine, New York, New York. Electronic address: rajesh.vedanthan@nyulangone.org.'}, {'ForeName': 'Jemima H', 'Initials': 'JH', 'LastName': 'Kamano', 'Affiliation': 'Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'DeLong', 'Affiliation': 'School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Violet', 'Initials': 'V', 'LastName': 'Naanyu', 'Affiliation': 'Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Binanay', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Chrysanthopoulou', 'Affiliation': 'School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Hogan', 'Affiliation': 'School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Horowitz', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Inui', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Menya', 'Affiliation': 'Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Vitalis', 'Initials': 'V', 'LastName': 'Orango', 'Affiliation': 'Academic Model Providing Access to Healthcare, Eldoret, Kenya.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Were', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Sylvester', 'Initials': 'S', 'LastName': 'Kimaiyo', 'Affiliation': 'Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.08.003']
1689,30559089,A Web-Based Coping Intervention by and for Parents of Very Young Children With Type 1 Diabetes: User-Centered Design.,"BACKGROUND
Management of type 1 diabetes (T1D) among children aged <6 years is exceptionally challenging for parents and caregivers. Metabolic and psychosocial outcomes among very young children with T1D (YC-T1D) are tightly associated with their parents' ability to meet these challenges. There is scant research testing interventions targeting these issues and few resources to equip health care providers with feasible and effective coping strategies for these parents. User-centered design (UCD) of a continuously accessible Web-based resource could be a mechanism for helping parents of YC-T1D cope more effectively with the complex challenges they face by providing them with information, solutions, and emotional support.
OBJECTIVE
The objectives of this paper are to (1) describe the application of UCD principles to the development of a Web-based coping intervention designed by and for parents of very young children (<6 years old) with T1D; (2) illustrate the use of crowdsourcing methods in obtaining the perspectives of parents, health care providers, and Web development professionals in designing and creating this resource; and (3) summarize the design of an ongoing randomized controlled trial (RCT) that is evaluating the effects of parental access to this resource on pertinent child and parent outcomes.
METHODS
This paper illustrates the application of UCD principles to create a Web-based coping resource designed by and for parents of YC-T1D. A Web-based Parent Crowd, a Health Care Provider Crowd, and a Focus Group of minority parents provided input throughout the design process. A formal usability testing session and design webinars yielded additional stakeholder input to further refine the end product.
RESULTS
This paper describes the completed website and the ongoing RCT to evaluate the effects of using this Web-based resource on pertinent parent and child outcomes.
CONCLUSIONS
UCD principles and the targeted application of crowdsourcing methods provided the foundation for the development, construction, and evaluation of a continuously accessible, archived, user-responsive coping resource designed by and for parents of YC-T1D. The process described here could be a template for the development of similar resources for other special populations that are enduring specific medical or psychosocial distress. The ongoing RCT is the final step in the UCD process and is designed to validate its merits.",2018,"User-centered design (UCD) of a continuously accessible Web-based resource could be a mechanism for helping parents of YC-T1D cope more effectively with the complex challenges they face by providing them with information, solutions, and emotional support.
","['parents of very young children (<6 years old) with T1D; (2', 'children aged <6 years', 'Parents of Very Young Children', 'very young children with T1D (YC-T1D', 'With Type 1 Diabetes']",['A Web-Based Coping Intervention'],['Metabolic and psychosocial outcomes'],"[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0375149,"User-centered design (UCD) of a continuously accessible Web-based resource could be a mechanism for helping parents of YC-T1D cope more effectively with the complex challenges they face by providing them with information, solutions, and emotional support.
","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wysocki', 'Affiliation': ""Nemours Children's Specialty Care, Center for Health Care Delivery Science, Nemours Children's Health System, Jacksonville, FL, United States.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pierce', 'Affiliation': ""Nemours Children's Hospital, Center for Health Care Delivery Science, Nemours Children's Health System, Orlando, FL, United States.""}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Caldwell', 'Affiliation': ""Nemours Children's Specialty Care, Center for Health Care Delivery Science, Nemours Children's Health System, Jacksonville, FL, United States.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Aroian', 'Affiliation': 'College of Nursing, University of Central Florida, Orlando, FL, United States.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'eCity Interactive, Inc, Philadelphia, PA, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Farless', 'Affiliation': 'Family Advisor, Ormond Beach, FL, United States.'}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Hafezzadeh', 'Affiliation': 'Family Advisor, Hayward, CA, United States.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'McAninch', 'Affiliation': ""Nemours Foundation, Department of Marketing and Communication, Nemours Children's Health System, Jacksonville, FL, United States.""}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Child Health Evaluation Research, Department of Pediatrics, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR diabetes,['10.2196/diabetes.9926']
1690,29557731,Evaluation of NeuroPage as a memory aid for people with multiple sclerosis: A randomised controlled trial.,"Memory problems are reported in 40%-60% of people with multiple sclerosis (MS). These problems affect independence and may limit the ability to benefit from rehabilitation. Our aim was to evaluate the effectiveness of NeuroPage for people with MS living in the community. A multicentre, single-blind, randomised controlled crossover trial was conducted. The intervention comprised the NeuroPage service, which sends reminder messages to mobile phones at pre-arranged times. In the control condition participants received ""non-memory texts"", that is, messages not aimed at providing a reminder; for example, supplying news headlines or sport updates. Outcome measures were completed using postal questionnaires after each condition. There were 38 participants aged 28 to 72 (mean 48, SD 11) and 10 (26%) were men. There were no significant differences between NeuroPage and control conditions on the Everyday Memory Questionnaire ( p = 0.41, d = 0.02). The number of daily diary items forgotten in the NeuroPage condition was significantly less than in the control (9% vs. 31%, p = 0.01, d = -0.64). Psychological distress was less in the NeuroPage condition than control ( p = 0.001, d = -0.84). Further evaluation of the effect on everyday memory is required.",2020,"Psychological distress was less in the NeuroPage condition than control (p = 0.001, d = -0.84).","['people with MS living in the community', 'people with multiple sclerosis', 'people with multiple sclerosis (MS', '38 participants aged 28 to 72 (mean 48, SD 11) and 10 (26%) were men']",['NeuroPage'],"['number of daily diary items forgotten', 'Everyday Memory Questionnaire', 'Psychological distress']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0588977', 'cui_str': 'Everyday memory questionnaire (assessment scale)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",38.0,0.269511,"Psychological distress was less in the NeuroPage condition than control (p = 0.001, d = -0.84).","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Goodwin', 'Affiliation': 'Division of Rehabilitation & Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nadina B', 'Initials': 'NB', 'LastName': 'Lincoln', 'Affiliation': 'Division of Rehabilitation & Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'das Nair', 'Affiliation': 'Division of Rehabilitation & Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bateman', 'Affiliation': 'The Oliver Zangwill Centre for Neuropsychological Rehabilitation, Princess of Wales Hospital, Ely, UK.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2018.1447973']
1691,24489418,Rejoinder to comments on Evaluation of Viable Dynamic Treatment Regimes in a Sequentially Randomized Trial of Advanced Prostate Cancer.,,2012,,['Advanced Prostate Cancer'],[],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",[],[],,0.0191607,,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rotnitzky', 'Affiliation': ''}, {'ForeName': 'Xihong', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Randall E', 'Initials': 'RE', 'LastName': 'Millikan', 'Affiliation': ''}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': ''}]",Journal of the American Statistical Association,[]
1692,31476741,"Investigation of paediatric PKU breath malodour, comparing glycomacropeptide with phenylalanine free L-amino acid supplements.","In clinical practice, caregivers of children with phenylketonuria (PKU) report that their children have breath malodour. This might be linked to the regular consumption of low phenylalanine (Phe)/Phe-free protein substitutes (PS), which are an essential component of a low-Phe diet. Oral malodour can negatively affect interpersonal communication, lead to bullying, low self-esteem and social isolation. In this longitudinal cross-over study, exhaled volatile organic compounds (VOCs) were measured using gas chromatography-ion mobility spectrometry. 40 children (20 PKU, 20 controls) were recruited. Subjects with PKU took either L-Amino Acid (L-AA) or Casein Glycomacropeptide (CGMP-AA) exclusively for 1 week, in a randomised order. On the seventh day, seven exhaled breath samples were collected over a 10 h period. Subjects then transferred to the other PS for a week and on day seven, provided seven further breath samples. All subjects had a standardised menu using low-Phe food alternatives and all food intake was measured and recorded. In the PKU group, the aim was to collect samples 30 min after consuming PS. In 3 subjects, breath was collected 5 min post-PS consumption. Fasted L-AA and CGMP-AA breath samples contained a similar number of VOC peaks (10-12) as controls. Longitudinal breath testing results demonstrate that there was no significant difference in the number of exhaled VOCs, comparing L-AA or CGMP-AA with controls, or between PS (12-18 VOC peaks). Breath analysed immediately after consumption of PS (n = 3) showed an immediate increase in the number of VOC peaks (25-30), but these were no longer detectable at 30 min post-consumption. This suggests PS have a transient effect on exhaled breath. Measurements taken 30 min after consuming L-AA or CGMP-AA were not significantly different to controls. This indicates that timing food and drinks with PS consumption may be a potential solution for carers to reduce or eliminate unpleasant PS-related breath odours.",2019,Measurements taken 30-min after consuming L-AA or CGMP-AA were not significantly different to controls.,"['40 children (20 PKU, 20 controls) were recruited', 'caregivers of children with phenylketonuria (PKU', 'Subjects with PKU took either']","['glycomacropeptide with phenylalanine free L-amino acid supplements', 'low phenylalanine (Phe)/Phe-free protein substitutes (PS', 'L-Amino Acid (L-AA) or Casein Glycomacropeptide (CGMP-AA']","['interpersonal communication, lead to bullying, low self-esteem and social isolation', 'number of exhaled VOCs', 'number of VOC peaks', 'exhaled breath']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0751434', 'cui_str': 'Phenylalanine Hydroxylase Deficiency'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0286762', 'cui_str': 'glycomacropeptide'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem (finding)'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}]",40.0,0.062927,Measurements taken 30-min after consuming L-AA or CGMP-AA were not significantly different to controls.,"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tiele', 'Affiliation': 'School of Engineering, University of Warwick, Coventry CV4 7AL, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daly', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hattersley', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': ''}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ashmore', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'MacDonald', 'Affiliation': ''}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Covington', 'Affiliation': ''}]",Journal of breath research,['10.1088/1752-7163/ab4097']
1693,31618127,"Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer.","PURPOSE
Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM).
PATIENTS AND METHODS
A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading.
RESULTS
Baseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced ( P = .024; median, 1.5 v 19 days). SOM incidence (43% v 65%; P = .009) and severity (grade 4 incidence, 16% v 30%; P = .045) also were improved. Intermediate improvements were seen with the 30-mg dose. Safety was comparable across arms, with no significant GC4419-specific toxicity nor increase of known toxicities of IMRT plus cisplatin. The 2-year follow-up for tumor outcomes is ongoing.
CONCLUSION
GC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety. A phase III trial (ROMAN; ClinicalTrials.gov identifier: NCT03689712) has begun.",2019,"With 90 mg GC4419 versus placebo, SOM duration was significantly reduced ( P = .024; median, 1.5 v 19 days).","['223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with', 'For Head and Neck Cancer', 'head and neck cancer']","['definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin', 'Radiotherapy and Cisplatin', 'GC4419, a superoxide dismutase mimetic, with placebo', 'GC4419 Versus Placebo', 'radiation therapy (RT', 'placebo', 'GC4419 or to receive placebo']","['SOM duration, incidence, and severity with acceptable safety', 'Safety', 'WHO grade of OM', 'efficacy and safety', 'duration, incidence, and severity of severe OM (SOM', 'SOM duration', 'Severe Oral Mucositis', 'GC4419-specific toxicity', 'SOM incidence', 'duration of SOM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0226896', 'cui_str': 'Cavitas Oris'}, {'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",223.0,0.508431,"With 90 mg GC4419 versus placebo, SOM duration was significantly reduced ( P = .024; median, 1.5 v 19 days).","[{'ForeName': 'Carryn M', 'Initials': 'CM', 'LastName': 'Anderson', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, IA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'Cancer Care Northwest, Spokane, WA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Saunders', 'Affiliation': 'North East Cancer Centre, Health Sciences North, Northern Ontario School of Medicine, Sudbury, Ontario, Canada.'}, {'ForeName': 'Amarinthia', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'Spartanburg Medical Center, Spartanburg, SC.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Dunlap', 'Affiliation': 'University of Louisville/James Graham Brown Cancer Center, Louisville, KY.'}, {'ForeName': 'Chaitali', 'Initials': 'C', 'LastName': 'Nangia', 'Affiliation': 'University of California Irvine Medical Center, Orange, CA.'}, {'ForeName': 'Arielle S', 'Initials': 'AS', 'LastName': 'Lee', 'Affiliation': 'HOPE Cancer Center of East Texas, Tyler, TX.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Gordon', 'Affiliation': 'East Carolina University, Greenville, NC.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kovoor', 'Affiliation': 'Texas Oncology, Plano West, Plano, TX.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Arevalo-Araujo', 'Affiliation': 'Pasco Pinellas Cancer Center, Holiday, FL.'}, {'ForeName': 'Voichita', 'Initials': 'V', 'LastName': 'Bar-Ad', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Abhinand', 'Initials': 'A', 'LastName': 'Peddada', 'Affiliation': 'Renown Regional Medical Center, Reno, NV.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Colvett', 'Affiliation': 'Mountain States Health Alliance, Johnson City, TN.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Jersey Shore University Medical Center, Neptune, NJ.'}, {'ForeName': 'Anshu K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Ashland-Bellefonte Cancer Center, Ashland, KY.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wheeler', 'Affiliation': 'Goshen Center for Cancer Care, Goshen, IN.'}, {'ForeName': 'Dukagjin', 'Initials': 'D', 'LastName': 'Blakaj', 'Affiliation': 'James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Bonomi', 'Affiliation': 'James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Sanjiv S', 'Initials': 'SS', 'LastName': 'Agarwala', 'Affiliation': ""St Luke's Cancer Center and Temple University, Easton, PA.""}, {'ForeName': 'Madhur', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Worden', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Holmlund', 'Affiliation': 'Galera Therapeutics, Malvern, PA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Brill', 'Affiliation': 'Galera Therapeutics, Malvern, PA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Downs', 'Affiliation': 'Statistics Collaborative, Washington, DC.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Sonis', 'Affiliation': 'Primary Endpoint Solutions, Watertown, MA.'}, {'ForeName': 'Sanford', 'Initials': 'S', 'LastName': 'Katz', 'Affiliation': 'Willis-Knighton Cancer Center, Shreveport, LA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Buatti', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, IA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01507']
1694,31617926,Assessment of Sarcopenia Among Community-Dwelling At-Risk Frail Adults Aged 65 Years and Older Who Received Multidomain Lifestyle Interventions: A Secondary Analysis of a Randomized Clinical Trial.,"Importance
There is little understanding of the outcomes associated with active lifestyle interventions for sarcopenia among older persons.
Objective
To determine the association of 6-month multidomain lifestyle interventions (physical exercise, nutritional enhancement, cognitive training, combined treatment, and standard care) with change in sarcopenia status and physical function among adults 65 years and older.
Design, Setting, and Participants
Post hoc secondary analysis of a parallel-group randomized clinical trial conducted from September 1, 2012, to September 1, 2014, at community centers providing services to elderly individuals in Singapore. Participants included a subsample of 92 community-dwelling prefrail or frail older persons with sarcopenia aged 65 years and older. Data were analyzed from June 1, 2017, to January 1, 2018.
Interventions
The 5 intervention groups were a 6-month duration of physical exercise that included resistance and balance training, nutritional enhancement with a commercial oral nutrition supplement formula, cognitive training, a combination of the preceding 3 interventions, and standard care (control).
Main Outcomes and Measures
Primary outcomes were changes in sarcopenia status and its components, appendicular skeletal muscle index (ASMI), knee extension strength (KES), and gait speed (GS) at 3 months and 6 months following the intervention. Sarcopenia was defined as the presence of both low ASMI and low KES and/or GS.
Results
In 92 participants with sarcopenia, the mean (SD) age was 70.0 (4.7) years and 59 (64.1%) were female. Seventy-eight participants received active interventions and 14 received standard care. Of 92 total participants, the number who remained sarcopenic was reduced to 48 (of 73) after 3 months and 51 (of 75) after 6 months of intervention, indicating that 25 of 92 participants (27.2%) experienced sarcopenia reduction at 3 months and 24 of 92 (26.1%) had sarcopenia reduction at 6 months. Low KES was present in 88 of 92 patients (95.6%), and low GS in 30 of 92 patients (32.6%) at baseline. Among the components of sarcopenia, GS had the greatest change associated with active interventions, with 22 of 30 participants (73.3%) free of low GS at 6 months; in comparison, 17 of 88 participants (19.3%) were free of low KES at 6 months and 7 of 92 participants (7.6%) were free of low ASMI at 6 months. Men experienced greater reduction in sarcopenia than women (χ2 = 5.925; P = .02), as did those with younger age (t = -2.078; P = .04) or higher ASMI (mean [SD] ASMI, 5.74 [0.77] vs 5.14 [0.77] kg/m2; P = .002). Participants in the active intervention group experienced statistically significant decreases in sarcopenia score and its components at 3 months and 6 months from baseline (F = 14.138; P < .001), but the intervention was not associated with significant differences in ASMI, KES, and GS vs standard care.
Conclusions and Relevance
This study suggests that older persons with sarcopenia are responsive to the effects of multidomain lifestyle interventions. Sarcopenia reduction was most pronounced through improved gait speed, and occurred more among those who were male, were younger, or had greater muscle mass.",2019,"Participants in the active intervention group experienced statistically significant decreases in sarcopenia score and its components at 3 months and 6 months from baseline (F = 14.138; P < .001), but the intervention was not associated with significant differences in ASMI, KES, and GS vs standard care.
","['older persons with sarcopenia', 'September 1, 2012, to September 1, 2014, at community centers providing services to elderly individuals in Singapore', '92 participants with sarcopenia, the mean (SD) age was 70.0 (4.7) years and 59 (64.1%) were female', 'Community-Dwelling At-Risk Frail Adults', 'adults 65 years and older', 'Participants included a subsample of 92 community-dwelling prefrail or frail older persons with sarcopenia aged 65 years and older', 'Aged 65 Years and Older']","['physical exercise that included resistance and balance training, nutritional enhancement with a commercial oral nutrition supplement formula, cognitive training, a combination of the preceding 3 interventions, and standard care (control', 'multidomain lifestyle interventions (physical exercise, nutritional enhancement, cognitive training, combined treatment, and standard care', 'Multidomain Lifestyle Interventions', 'active interventions and 14 received standard care']","['ASMI', 'gait speed', 'sarcopenia reduction', 'Sarcopenia reduction', 'reduction in sarcopenia', 'changes in sarcopenia status and its components, appendicular skeletal muscle index (ASMI), knee extension strength (KES), and gait speed (GS', 'ASMI, KES, and GS vs standard care', 'number who remained sarcopenic', 'sarcopenia score']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",78.0,0.0611313,"Participants in the active intervention group experienced statistically significant decreases in sarcopenia score and its components at 3 months and 6 months from baseline (F = 14.138; P < .001), but the intervention was not associated with significant differences in ASMI, KES, and GS vs standard care.
","[{'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Singapore Immunology Network, Biology of Ageing Laboratory, Agency for Science Technology and Research, Biopolis, Singapore.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Niti', 'Affiliation': 'Performance and Technology Assessment Department, Ministry of Health, Singapore.'}, {'ForeName': 'Keng Bee', 'Initials': 'KB', 'LastName': 'Yap', 'Affiliation': 'Geriatric Medicine and Palliative Medicine Department, Ng Teng Fong General Hospital, Singapore.'}, {'ForeName': 'Crystal Tze Ying', 'Initials': 'CTY', 'LastName': 'Tan', 'Affiliation': 'Singapore Immunology Network, Biology of Ageing Laboratory, Agency for Science Technology and Research, Biopolis, Singapore.'}, {'ForeName': 'Ma Shwe', 'Initials': 'MS', 'LastName': 'Zin Nyunt', 'Affiliation': 'Gerontology Research Programme, Yong Loo Lin School of Medicine, Department of Psychological Medicine, National University Health System, National University of Singapore, Singapore.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Gerontology Research Programme, Yong Loo Lin School of Medicine, Department of Psychological Medicine, National University Health System, National University of Singapore, Singapore.'}, {'ForeName': 'Boon Yeow', 'Initials': 'BY', 'LastName': 'Tan', 'Affiliation': ""Medical Services Department, St Luke's Hospital, Singapore.""}, {'ForeName': 'Gribson', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': ""Rehabilitation Services Division, St Luke's Hospital, Singapore.""}, {'ForeName': 'Sue Anne', 'Initials': 'SA', 'LastName': 'Khoo', 'Affiliation': 'Psychological Medicine Department, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Sue Mei', 'Initials': 'SM', 'LastName': 'Chan', 'Affiliation': 'Nutrition and Dietetics Department, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Yap', 'Affiliation': 'Geriatric Medicine Department, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Larbi', 'Affiliation': 'Singapore Immunology Network, Biology of Ageing Laboratory, Agency for Science Technology and Research, Biopolis, Singapore.'}, {'ForeName': 'Tze Pin', 'Initials': 'TP', 'LastName': 'Ng', 'Affiliation': 'Gerontology Research Programme, Yong Loo Lin School of Medicine, Department of Psychological Medicine, National University Health System, National University of Singapore, Singapore.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.13346']
1695,31539073,Effect of an Electronic Medication Reconciliation Intervention on Adverse Drug Events: A Cluster Randomized Trial.,"Importance
Adverse drug events (ADEs) account for up to 16% of emergency department (ED) visits and 7% of hospital admissions. Medication reconciliation is required for hospital accreditation because it can reduce medication discrepancies, but there is no evidence that reducing discrepancies reduces ADEs or other adverse outcomes.
Objective
To evaluate whether electronic medication reconciliation reduces ADEs, medication discrepancies, and other adverse outcomes compared with usual care.
Design, Setting, and Participants
This cluster randomized trial involved 3491 patients who were discharged from 2 medical units and 2 surgical units at the McGill University Health Centre, Montreal, Quebec, Canada, between October 2014 and November 2016. Data analysis took place from July 2017 to July 2019.
Intervention
The RightRx intervention electronically retrieved community drugs from the provincial insurer and aligned them with in-hospital drugs to facilitate reconciliation and communication at care transitions.
Main Outcomes and Measures
The primary outcome was ADEs in 30 days after discharge. Secondary outcomes included medication discrepancies, ED visits, hospital readmissions, and a composite outcome of ED visits, readmissions, and death up to 90 days after discharge.
Results
Of 4656 eligible patients, 3567 (76.6%) consented to participate (2060 [57.8%] men; mean [SD] age, 69.8 [14.9] years). Overall, 76 patients died during the hospital stay, so 3491 patients were included in the analysis. There was no significant difference in the risk of ADEs between intervention and control groups (76 [4.6%] vs 73 [4.0%]; OR, 0.97; 95% CI, 0.33-1.48), ED visits (433 [26.2%] vs 488 [26.6%]; OR, 0.83; 95% CI, 0.36-1.42), hospital readmission (170 [10.3%] vs 261 [14.2%]; OR, 0.22; 95% CI, 0.06-1.14), or the composite outcome (447 [27.0%] vs 506 [27.6%]; OR, 0.75; 95% CI, 0.34-1.27) at 30 days. Medication discrepancies were significantly reduced in the intervention group compared with the control group (437 [26.4%] vs 1029 [56.0%]; OR, 0.24; 95% CI, 0.12-0.57). Changes made to community medications (OR, 1.05; 95% CI, 1.01-1.10) and new medications (OR, 1.09; 95% CI, 1.01-1.18) were significant risk factors for ADEs.
Conclusions and Relevance
Electronic medication reconciliation reduced medication discrepancies but did not reduce ADEs or other adverse outcomes. Hospital accreditation should focus on interventions that reduce the risk of adverse events for patients with multiple changes to community medications.
Trial Registration
ClinicalTrials.gov identifier: NCT01179867.",2019,"Medication discrepancies were significantly reduced in the intervention group compared with the control group (437 [26.4%] vs 1029 [56.0%]; OR, 0.24; 95% CI, 0.12-0.57).","['4656 eligible patients, 3567 (76.6%) consented to participate (2060 [57.8%] men', 'patients with multiple changes to community medications', 'mean [SD] age, 69.8 [14.9] years', '76 patients died during the hospital stay, so 3491 patients were included in the analysis', '3491 patients who were discharged from 2 medical units and 2 surgical units at the McGill University Health Centre, Montreal, Quebec, Canada, between October 2014 and November 2016']",['Electronic Medication Reconciliation Intervention'],"['risk of ADEs', 'Medication discrepancies', 'hospital readmission', 'ADEs in 30 days after discharge', 'medication discrepancies, ED visits, hospital readmissions, and a composite outcome of ED visits, readmissions, and death up to 90 days after discharge', 'Adverse Drug Events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2317067', 'cui_str': 'Medication Reconciliation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}]",76.0,0.202716,"Medication discrepancies were significantly reduced in the intervention group compared with the control group (437 [26.4%] vs 1029 [56.0%]; OR, 0.24; 95% CI, 0.12-0.57).","[{'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Tamblyn', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Abrahamowicz', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Buckeridge', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bustillo', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Forster', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Nadyne', 'Initials': 'N', 'LastName': 'Girard', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Habib', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hanley', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Division of Geriatric Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Siyana', 'Initials': 'S', 'LastName': 'Kurteva', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Ari N', 'Initials': 'AN', 'LastName': 'Meguerditchian', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Moraga', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Motulsky', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal, School of Public Health, University of Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Petrella', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Daniala L', 'Initials': 'DL', 'LastName': 'Weir', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Winslade', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.10756']
1696,31166599,Efficacy and Safety of Alirocumab 300 mg Every 4 Weeks in Individuals With Type 2 Diabetes on Maximally Tolerated Statin.,"CONTEXT
In the ODYSSEY CHOICE I trial, alirocumab 300 mg every 4 weeks (Q4W) was assessed in patients with hypercholesterolemia. Alirocumab efficacy and safety were evaluated in a patient subgroup with type 2 diabetes mellitus (T2DM) and who were receiving maximally tolerated statins with or without other lipid-lowering therapies.
METHODS
Participants received either alirocumab 300 mg Q4W (n = 458, including 96 with T2DM) or placebo (n = 230, including 50 with T2DM) for 48 weeks, with alirocumab dose adjustment to 150 mg every 2 weeks at Week (W) 12 if W8 low-density lipoprotein cholesterol (LDL-C) levels were ≥70 mg/dL or ≥ 100 mg/dL, depending on cardiovascular risk, or if LDL-C reduction was <30% from baseline. Efficacy end points included percentage change from baseline to W24 for lipids, and time-averaged LDL-C over W21 to W24.
RESULTS
In individuals with T2DM, LDL-C reductions from baseline to W24 and the average of W21 to W24 were significantly greater with alirocumab (-61.6% and -68.8%, respectively) vs placebo. At W24, alirocumab significantly reduced levels of non-high-density lipoprotein cholesterol (HDL-C) and other lipids. At W24, 85.9% and 12.5% of individuals in the alirocumab and placebo groups, respectively, reached both non-HDL-C <100 mg/dL and LDL-C <70 mg/dL. At W12, In total, 18% of alirocumab-treated participants received dose adjustment. The most common treatment-emergent adverse events were upper respiratory tract infection and injection-site reaction. No clinically significant changes in fasting plasma glucose and glycated hemoglobin were observed.
CONCLUSION
In individuals with T2DM, alirocumab 300 mg Q4W was generally well tolerated and efficacious in reducing atherogenic lipoproteins.",2019,"At W24, alirocumab also significantly reduced levels of non-HDL-C, apolipoprotein B, triglycerides, and lipoprotein (a).","['patient subgroup with type 2 diabetes (T2DM) on maximally tolerated statins with/without other lipid-lowering therapies', 'patients with hypercholesterolemia', 'Individuals with Type 2 Diabetes on Maximally Tolerated Statin']","['alirocumab', 'Alirocumab 300 mg', 'placebo', 'alirocumab 300 mg Q4W']","['levels of non-HDL-C, apolipoprotein B, triglycerides, and lipoprotein (a', 'percentage change from baseline to W24 for LDL-C and other lipids, and time-averaged LDL-C', 'alirocumab efficacy and safety', 'fasting plasma glucose and glycated hemoglobin', 'tolerated and efficacious in reducing atherogenic lipoproteins', 'LDL-C reductions', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.124319,"At W24, alirocumab also significantly reduced levels of non-HDL-C, apolipoprotein B, triglycerides, and lipoprotein (a).","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Medicine I, University Hospital, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Rader', 'Affiliation': 'Department of Medicine and Genetics, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennysylvania.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'Department of Internal Medicine, Division of Clinical Pharmacology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bergeron', 'Affiliation': 'Clinique des Maladies Lipidiques, Department of Medicine, Centre Hospitalier Universitaire de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Gisle', 'Initials': 'G', 'LastName': 'Langslet', 'Affiliation': 'Lipid Clinic, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Garen', 'Initials': 'G', 'LastName': 'Manvelian', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Bujas-Bobanovic', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Eli M', 'Initials': 'EM', 'LastName': 'Roth', 'Affiliation': 'The Sterling Research Group and University of Cincinnati, Cincinnati, Ohio.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02703']
1697,29628829,Using dexamethasone as an adjuvant to levobupivacaine in epidural anesthesia to change the pain intensity and duration in painless labor.,"Background and Objective
This is a randomized controlled trial aiming at comparing the effectiveness of levobupivacaine alone versus a levobupivacaine with dexamethasone in the epidural injection for painless labor.
Patients and Methods
This is a comparative randomized controlled double-blinded clinical trial with 49 patients were included in this study, all of them were primigravidas and were during vaginal delivery with a cervical dilatation ≥4 cm. Patients were included randomly in one of two groups either Group C (26 cases) with epidural levobupivacaine 0.125% in normal saline or Group D (23 cases) with epidural levobupivacaine 0.125% in normal saline combined with dexamethasone 8 mg. The duration of a second dose request, total dose given, neonatal outcome and adverse effects of epidural were recorded.
Results
Group D showed a longer duration of analgesia than Group C (80.5 ± 12.39 min in Group D vs. 61.75 ± 10.74 min in Group C) with a P < 0.05 (0.001). Furthermore, the patients in Group D received smaller dose of levobupivacaine than those in Group C with a statistically significant difference (90.87 ± 33.42 vs. 127.21 ± 40.68 mg with P = 0.002). There were no statistical differences between the two groups regarding hemodynamics, pain score, neonatal outcome, and complications.
Conclusion
Dexamethasone in epidural analgesia for painless labor has a prolonged duration of analgesia with no complications for both the mother and the infant.",2018,"Results
Group D showed a longer duration of analgesia than Group C (80.5 ± 12.39 min in Group D vs. 61.75 ± 10.74 min in Group C) with a P < 0.05 (0.001).","['49 patients were included in this study, all of them were primigravidas and were during vaginal delivery with a cervical dilatation ≥4 cm', 'painless labor']","['epidural levobupivacaine 0.125% in normal saline or Group D (23 cases) with epidural levobupivacaine 0.125% in normal saline combined with dexamethasone', 'levobupivacaine', 'Dexamethasone', 'dexamethasone', 'levobupivacaine with dexamethasone']","['pain intensity and duration in painless labor', 'longer duration of analgesia', 'hemodynamics, pain score, neonatal outcome, and complications', 'duration of a second dose request, total dose given, neonatal outcome and adverse effects of epidural']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0079103', 'cui_str': 'Cervical Dilatation'}, {'cui': 'C0234226', 'cui_str': 'Painless (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0234226', 'cui_str': 'Painless (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",49.0,0.176823,"Results
Group D showed a longer duration of analgesia than Group C (80.5 ± 12.39 min in Group D vs. 61.75 ± 10.74 min in Group C) with a P < 0.05 (0.001).","[{'ForeName': 'Hassan Mohamed', 'Initials': 'HM', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Wahdan', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_435_17']
1698,29628832,Efficacy and safety of pulsed radiofrequency and steroid injection for intercostobrachial neuralgia in postmastectomy pain syndrome - A clinical trial.,"Background
Breast cancer is a common neoplastic tumor in women, and the postmastectomy pain syndrome has been reported frequently after surgical treatment. The injury of the intercostobrachial nerve is considered the major cause of this type of pain.
Purpose
Evaluation of efficacy and safety of pulsed radiofrequency (PRF) and steroid injection on the 2 nd and 3 rd thoracic (T2 and T3) dorsal root ganglions (DRGs) for intercostobrachial neuralgia (ICBN) postmastectomy.
Patients and Methods
This study was conducted on 100 patients with ICBN postmastectomy. The PRF waves were applied for 120 s twice on T2 and T3 DRGs then 1 ml of 4 mg dexamethasone and 1 ml of bupivacaine 0.25% were injected at each level then the technique was repeated three times 1 week apart for each patient.
Results
After 6 months from the latest intervention, the mean of visual analog scale dropped from 7.48 to 4.7 ( P = 0.005712) and the mean of the quality of life scale improved to 6.88 after being 4.66 ( P < 0.00001) before the intervention and 64.68% of the patients decided that they would certainly repeat the procedure if they could go back in time and 66.64% would certainly recommend the same procedure to a family member. The analgesics consumption decreased mainly in the 1 st month but increased again after 6 months (not significant). No serious complications were recorded.
Conclusions
PRF and steroid injection on T2 and T3 DRGs assumed an effective and safe method for ICBN postmastectomy treatment.",2018,"After 6 months from the latest intervention, the mean of visual analog scale dropped from 7.48 to 4.7 ( P = 0.005712) and the mean of the quality of life scale improved to 6.88 after being 4.66 ( P < 0.00001) before the intervention and 64.68% of the patients decided that they would certainly repeat the procedure if they could go back in time and 66.64% would certainly recommend the same procedure to a family member.","['100 patients with ICBN postmastectomy', 'intercostobrachial neuralgia']","['pulsed radiofrequency (PRF) and steroid injection', 'bupivacaine', 'pulsed radiofrequency and steroid injection', 'dexamethasone']","['serious complications', 'mean of the quality of life scale', 'mean of visual analog scale', 'Efficacy and safety', 'analgesics consumption']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",100.0,0.0217605,"After 6 months from the latest intervention, the mean of visual analog scale dropped from 7.48 to 4.7 ( P = 0.005712) and the mean of the quality of life scale improved to 6.88 after being 4.66 ( P < 0.00001) before the intervention and 64.68% of the patients decided that they would certainly repeat the procedure if they could go back in time and 66.64% would certainly recommend the same procedure to a family member.","[{'ForeName': 'Beshoy Nabil', 'Initials': 'BN', 'LastName': 'Fam', 'Affiliation': 'Department of Anesthesiology and Pain Management, Nasser Institute for Research and Treatment, Cairo, Egypt.'}, {'ForeName': 'Ghada Gamal El-Din', 'Initials': 'GGE', 'LastName': 'El-Sayed', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Raafat Mahfouz', 'Initials': 'RM', 'LastName': 'Reyad', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ikramy', 'Initials': 'I', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_576_17']
1699,29628834,Comparison of analgesic efficacy and safety of continuous epidural infusion versus local infiltration and systemic opioids in video-assisted thoracoscopic surgery decortication in pediatric empyema patients.,"Introduction
The stripping of the densely innervated and inflamed parietal pleura in empyema during video-assisted thoracoscopic surgery (VATS) decortication can lead to significant pain and major postoperative respiratory compromise. Hence, we compared the analgesic efficacy of continuous epidural infusion versus local infiltration and systemic opioids in children undergoing VATS decortications.
Methodology
Following ethics approval and informed consent, forty patients from 1 to 12 years of age were randomized into two groups, Group E (epidural) and Group L (local infiltration) after induction of anesthesia. In Group E, a thoracic epidural catheter was inserted between T4 and T8. A bolus dose of 0.5 ml/kg of 0.25% injection bupivacaine was given epidurally before incision. Postoperatively, the patients received epidural infusion with bupivacaine and fentanyl up to 48 h using an elastomeric balloon pump. In Group L, patients received local infiltration of bupivacaine (2 mg/kg) and lignocaine (5 mg/kg) at the port sites before incision and at the end of surgery. They also received injection tramadol 1 mg/kg intravenously TDS with thrice daily postoperatively. The pain scores (Face, Legs, Activity, Cry, Consolability/ Wong-Baker FACES scale) were assessed every 4 h on the 1 st day and 6 h on the 2 nd day. Injection diclofenac 1 mg/kg intravenous was used as a rescue analgesic for pain scores more than 4. Side effects such as nausea, vomiting, constipation, and motor blockade were noted. Quantitative and categorical data were assessed using t -test and Chi-square test, respectively.
Results
The pain scores were lower in the epidural group than in the local infiltration group at 0, 4, and 20 h postoperatively ( P = 0.001, 0.01, and 0.038, respectively). Seventeen out of nineteen patients required rescue analgesia in the local infiltration group in the postoperative period as compared to five patients in the epidural group with a P value of 0.000081.
Conclusion
Epidural analgesia can be considered as an effective modality of reducing pain in patients undergoing VATS decortication for empyema in pediatric patients.",2018,"The pain scores were lower in the epidural group than in the local infiltration group at 0, 4, and 20 h postoperatively ( P = 0.001, 0.01, and 0.038, respectively).","['forty patients from 1 to 12 years of age', 'pediatric empyema patients', 'children undergoing VATS decortications', 'patients undergoing VATS decortication for empyema in pediatric patients']","['elastomeric balloon pump', 'bupivacaine', 'injection tramadol', 'continuous epidural infusion versus local infiltration and systemic opioids', 'lignocaine', 'bupivacaine and fentanyl', 'video-assisted thoracoscopic surgery decortication', 'Injection diclofenac', 'video-assisted thoracoscopic surgery (VATS) decortication']","['analgesic efficacy', 'rescue analgesia', 'pain scores (Face, Legs, Activity, Cry, Consolability/ Wong-Baker FACES scale', 'pain scores', 'nausea, vomiting, constipation, and motor blockade', 'thoracic epidural catheter']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0014009', 'cui_str': 'Empyema'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C2678502', 'cui_str': 'Decortication (procedure)'}]","[{'cui': 'C0444925', 'cui_str': 'elastomeric'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump, device (physical object)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C2678502', 'cui_str': 'Decortication (procedure)'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0222045'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter, device (physical object)'}]",19.0,0.0657055,"The pain scores were lower in the epidural group than in the local infiltration group at 0, 4, and 20 h postoperatively ( P = 0.001, 0.01, and 0.038, respectively).","[{'ForeName': 'Priyanka Pradeep', 'Initials': 'PP', 'LastName': 'Karnik', 'Affiliation': 'Department of Anesthesiology, King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai, Maharashtra, India.'}, {'ForeName': 'Nandini Malay', 'Initials': 'NM', 'LastName': 'Dave', 'Affiliation': 'Department of Anesthesiology, King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai, Maharashtra, India.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Garasia', 'Affiliation': 'Department of Anesthesiology, King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai, Maharashtra, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_659_17']
1700,29628839,A prospective randomized controlled study to evaluate and compare GlideScope with Macintosh laryngoscope for ease of endotracheal intubation in adult patients undergoing elective surgery under general anesthesia.,"Background
The aim of the study was to compare the ease the intubation using GlideScope video laryngoscope and Macintosh laryngoscope in adult patients undergoing elective surgery under general anesthesia.
Materials and Methods
A total of 200 American Society of Anesthesiologists I-II patients of either sex, in the age group of 18-60 years were included in the study. Patients were randomly allocated to two groups. We assessed ease of intubation depending on time to tracheal intubation, number of attempts, glottic view (Cormack-Lehane grade [CL grade] and percentage of glottis opening [POGO]) and intubation difficulty score (IDS), hemodynamic variables and any intra- and post-operative adverse events.
Results
The rate of successful endotracheal intubation (ETI) in both groups was 100% in the first attempt. The time required for successful ETI was 24.89 ± 5.574 in Group G and 20.68 ± 3.637 in Group M ( P < 0.001) found to be statistically significant. There was significant improvement in glottic view with GlideScope (as assessed by POGO score 66.71 ± 29.929 and 94.40 ± 10.476 in group G and 75.85 ± 26.969 and 74.20 ± 29.514 Group M and CL grading [ P < 0.001]). A comparison of mean IDS between two groups revealed intubation was easier with the use of GlideScope. The hemodynamic response to intubation was significantly lesser with the use of GlideScope when compared with Macintosh laryngoscope. The incidence of adverse events, though minor like superficial lip or tongue bleed, was similar in two groups.
Conclusions
GlideScope offers superiority over Macintosh laryngoscope in terms of laryngeal views and the difficulty encountered at ETI in an unselected population.",2018,The hemodynamic response to intubation was significantly lesser with the use of GlideScope when compared with Macintosh laryngoscope.,"['adult patients undergoing elective surgery under general anesthesia', '200 American Society of Anesthesiologists I-II patients of either sex, in the age group of 18-60 years were included in the study']","['endotracheal intubation', 'GlideScope with Macintosh laryngoscope', 'GlideScope video laryngoscope and Macintosh laryngoscope']","['glottic view with GlideScope', 'hemodynamic response to intubation', 'ease of intubation depending on time to tracheal intubation, number of attempts, glottic view (Cormack-Lehane grade [CL grade] and percentage of glottis opening [POGO]) and intubation difficulty score (IDS), hemodynamic variables and any intra- and post-operative adverse events', 'rate of successful endotracheal intubation (ETI', 'time required for successful ETI', 'incidence of adverse events', 'mean IDS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",200.0,0.110621,The hemodynamic response to intubation was significantly lesser with the use of GlideScope when compared with Macintosh laryngoscope.,"[{'ForeName': 'Anudeep', 'Initials': 'A', 'LastName': 'Jafra', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Satinder', 'Initials': 'S', 'LastName': 'Gombar', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Kapoor', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Harpreet Singh', 'Initials': 'HS', 'LastName': 'Sandhu', 'Affiliation': 'Department of Anesthesia, Healing Touch Hospital, Ambala, Haryana, India.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Kumari', 'Affiliation': 'Department of Anesthesia and Intensive Care, Dr. S. N. Medical College and Associated Group of Hospitals, Jodhpur, Rajasthan, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_543_17']
1701,29566588,Effectiveness of ReSET; a strategic executive treatment for executive dysfunctioning in patients with Parkinson's disease.,"In this multicentre randomised controlled trial (RCT), 43 patients with Parkinson's disease (PD) were randomly allocated to either the experimental condition receiving cognitive rehabilitation including strategy training (ReSET; Strategic Executive Treatment, n = 24) or to the control condition receiving computerised repetitive practice training for attention (Cogniplus, n = 16). We expected that strategy training (ReSET) would be more effective than cognitive training (Cogniplus) in improving patients' everyday life executive functioning. Neuropsychological assessment was administered at baseline, at 2 weeks and 3-5 months post-treatment. Primary outcome measure was the Role Resumption List (RRL). Secondary outcome measures were treatment goal attainment (TGA), Dysexecutive Questionnaire (DEX), Parkinson's Disease Questionnaire (PDQ-39), Zarit Burden Interview (ZBI) and neuropsychological tests. No effects of treatment were found on the primary outcome measure and on neuropsychological tests, except for one test of attention. At 2 weeks and 3-5 months post-treatment, PD patients in both the ReSET and Cogniplus group reported a significant improvement in everyday life executive functioning, as measured with TGA and the DEX-self, with an advantage for ReSET only shortly after treatment. Given these results and that PD patients were able to adhere to these treatments despite their motor symptoms and fatigue (i.e., the drop-out rate was small), we conclude that both strategy training and cognitive training for impairments in EF might be beneficial and feasible for PD patients.",2020,"No effects of treatment were found on the primary outcome measure and on neuropsychological tests, except for one test of attention.","[""patients with Parkinson's disease"", ""43 patients with Parkinson's disease (PD""]","['ReSET', 'experimental condition receiving cognitive rehabilitation including strategy training (ReSET; Strategic Executive Treatment, n\u2009=\u200924) or to the control condition receiving computerised repetitive practice training for attention (Cogniplus, n\u2009=\u200916', 'strategy training (ReSET', 'cognitive training (Cogniplus']","[""treatment goal attainment (TGA), Dysexecutive Questionnaire (DEX), Parkinson's Disease Questionnaire (PDQ-39), Zarit Burden Interview (ZBI) and neuropsychological tests"", 'Role Resumption List (RRL', 'everyday life executive functioning']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",43.0,0.0434578,"No effects of treatment were found on the primary outcome measure and on neuropsychological tests, except for one test of attention.","[{'ForeName': 'Thialda T', 'Initials': 'TT', 'LastName': 'Vlagsma', 'Affiliation': 'Department of Clinical & Developmental Neuropsychology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Annelien A', 'Initials': 'AA', 'LastName': 'Duits', 'Affiliation': 'Department of Psychiatry and Psychology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Hilde T', 'Initials': 'HT', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Medical psychology, Medical Center Nij Smellinghe, Drachten, The Netherlands.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jacoba M', 'Initials': 'JM', 'LastName': 'Spikman', 'Affiliation': 'Department of Clinical & Developmental Neuropsychology, University of Groningen, Groningen, The Netherlands.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2018.1452761']
1702,31613408,Myelomeningocele sac associated with worse lower-extremity neurological sequelae: evidence for prenatal neural stretch injury?,"OBJECTIVE
To determine whether the presence of a myelomeningocele (MMC) sac and sac size correlate with compromised lower-extremity function in fetuses with open spinal dysraphism.
METHODS
A radiology database search was performed to identify cases of MMC and myeloschisis (MS) diagnosed prenatally in a single center from 2013 to 2017. All cases were evaluated between 18 and 25 weeks. Ultrasound reports were reviewed for talipes and impaired lower-extremity motion. In MMC cases, sac volume was calculated from ultrasound measurements. Magnetic resonance imaging reports were reviewed for hindbrain herniation. The association of presence of a MMC sac and sac size with talipes and impaired lower-extremity motion was assessed. Post-hoc analysis of data from the multicenter Management of Myelomeningocele Study (MOMS) randomized controlled trial was performed to confirm the study findings.
RESULTS
In total, 283 MMC and 121 MS cases were identified. MMC was associated with a lower incidence of hindbrain herniation than was MS (80.9% vs 100%; P < 0.001). Compared with MS cases, MMC cases with hindbrain herniation had a higher rate of talipes (28.4% vs 16.5%, P = 0.02) and of talipes or lower-extremity impairment (34.9% vs 19.0%, P = 0.002). Although there was a higher rate of impaired lower-extremity motion alone in MMC cases with hindbrain herniation than in MS cases, the difference was not statistically significant (6.6% vs 2.5%; P = 0.13). Among MMC cases with hindbrain herniation, mean sac volume was higher in those associated with talipes compared with those without talipes (4.7 ± 4.2 vs 3.0 ± 2.6 mL; P = 0.002). Review of the MOMS data demonstrated similar findings; cases with a sac on baseline imaging had a higher incidence of talipes than did those without a sac (28.2% vs 7.5%; P = 0.007).
CONCLUSIONS
In fetuses with open spinal dysraphism, the presence of a MMC sac was associated with fetal talipes, and this effect was correlated with sac size. The presence of a larger sac in fetuses with open spinal dysraphism may result in additional injury through mechanical stretching of the nerves, suggesting another acquired mechanism of injury to the exposed spinal tissue. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.",2020,Mean sac volume was higher in cases of MMC associated with talipes compared to those cases without talipes (4.7±4.2mL vs 3.0±2.6mL; p=0.002).,"['A single center, retrospective radiology database search was performed for cases of myelomeningocele (MMC) and myeloschisis (MS) prenatally diagnosed from 2013-2017']",['MMC'],"['sac volume', 'Mean sac volume', 'prenatal talipes and impaired fetal leg movements', 'hindbrain herniation']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0025312', 'cui_str': 'Myelomeningocele'}, {'cui': 'C0266507', 'cui_str': 'Myeloschisis (disorder)'}]",[],"[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301937', 'cui_str': 'Talipedes'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0035507', 'cui_str': 'Hind Brain'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]",,0.0408787,Mean sac volume was higher in cases of MMC associated with talipes compared to those cases without talipes (4.7±4.2mL vs 3.0±2.6mL; p=0.002).,"[{'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Oliver', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, PA, USA.'}, {'ForeName': 'G G', 'Initials': 'GG', 'LastName': 'Heuer', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, PA, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The George Washington University Biostatistics Center, Washington, DC, USA.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Burrows', 'Affiliation': 'The George Washington University Biostatistics Center, Washington, DC, USA.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Didier', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, PA, USA.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'DeBari', 'Affiliation': ""Center for Fetal Diagnosis and Treatment, Children's Hospital of Philadelphia, PA, USA.""}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Martin-Saavedra', 'Affiliation': ""Center for Fetal Diagnosis and Treatment, Children's Hospital of Philadelphia, PA, USA.""}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Moldenhauer', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, PA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jatres', 'Affiliation': ""Center for Fetal Diagnosis and Treatment, Children's Hospital of Philadelphia, PA, USA.""}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Howell', 'Affiliation': ""Center for Fetal Diagnosis and Treatment, Children's Hospital of Philadelphia, PA, USA.""}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Adzick', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, PA, USA.'}, {'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Coleman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, PA, USA.'}]",Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology,['10.1002/uog.21891']
1703,31533277,Medical Outcomes in Women Who Became Pregnant after Vaccination with a Virus-Like Particle Experimental Vaccine against Influenza A (H1N1) 2009 Virus Tested during 2009 Pandemic Outbreak.,"The clinical effects and immunological response to the influenza vaccine in women who later become pregnant remain to be thoroughly studied. Here, we report the medical outcomes of 40 women volunteers who became pregnant after vaccination with an experimental virus-like particle (VLP) vaccine against pandemic influenza A(H1N1)2009 (influenza A(H1N1)pdm09) and their infants. When included in the VLP vaccine trial, none of the women were pregnant and were randomly assigned to one of the following groups: (1) placebo, (2) 15 μg dose of VLP vaccine, or (3) 45 μg dose of VLP vaccine. These 40 women reported becoming pregnant during the follow-up phase after receiving the placebo or VLP vaccine. Women were monitored throughout pregnancy and their infants were monitored until one year after birth. Antibody titers against VLP were measured in the mothers and infants at delivery and at six months and one year after birth. The incidence of preeclampsia, fetal death, preterm delivery, and premature rupture of membranes was similar among groups. All vaccinated women and their infants elicited antibody titers (≥1:40). Women vaccinated prior to pregnancy had no adverse events that were different from the nonvaccinated population. Even though this study is limited by the sample size, the results suggest that the anti-influenza A(H1N1)pdm09 VLP experimental vaccine applied before pregnancy is safe for both mothers and their infants.",2019,Antibody titers against VLP were measured in the mothers and infants at delivery and at six months and one year after birth.,"['women who later become pregnant remain', 'Who Became Pregnant after Vaccination with a Virus-Like Particle Experimental Vaccine against Influenza A (H1N1) 2009', 'Women', '40 women volunteers who became pregnant after vaccination with an experimental virus-like particle (VLP) vaccine against pandemic influenza A(H1N1)2009 (influenza A(H1N1)pdm09) and their infants', '40 women reported becoming pregnant during the follow-up phase after receiving the']","['placebo or VLP vaccine', 'placebo, (2) 15 μg dose of VLP vaccine, or (3) 45 μg dose of VLP vaccine', 'influenza vaccine']","['incidence of preeclampsia, fetal death, preterm delivery, and premature rupture of membranes', 'Antibody titers against VLP', 'adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles (morphologic abnormality)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C2936379', 'cui_str': 'Vaccines, Virus-Like Particle'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.0839513,Antibody titers against VLP were measured in the mothers and infants at delivery and at six months and one year after birth.,"[{'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Cérbulo-Vázquez', 'Affiliation': 'Facultad de Medicina, Plan de Estudios Combinados en Medicina (MD, PhD Program), Universidad Nacional Autónoma de México, Mexico City CP 04510, Mexico. cerbulo@unam.mx.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Arriaga-Pizano', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. landapi@hotmail.com.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Cruz-Cureño', 'Affiliation': 'Escuela Nacional de Ciencias Biológicas, Programa de Inmunología, Instituto Politécnico Nacional, Mexico City CP 11340, Mexico. gabrielacruz30@gmail.com.'}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Boscó-Gárate', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. ibosco45@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ferat-Osorio', 'Affiliation': 'Servicio de Cirugía Gastrointestinal, Unidad Médica de Alta Especialidad, Hospital de Especialidades Dr Bernardo Sepúlveda Gutiérrez, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. eduardoferat@prodigy.net.mx.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Pastelin-Palacios', 'Affiliation': 'Departamento de Biología, Facultad de Química, Universidad Nacional Autónoma de México, Mexico City CP 04510, Mexico. rodolfop@unam.mx.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Figueroa-Damian', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Perinatología, Mexico City CP 11000, Mexico. rfd6102@yahoo.com.mx.'}, {'ForeName': 'Denisse', 'Initials': 'D', 'LastName': 'Castro-Eguiluz', 'Affiliation': 'Consejo Nacional de Ciencia y Tecnología (CONACYT)- Departamento de Investigación Clínica, Instituto Nacional de Cancerología, Mexico City CP 14080, Mexico. angeldenisse@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Mancilla-Ramirez', 'Affiliation': 'Escuela Superior de Medicina, Instituto Politécnico Nacional; Hospital de la Mujer, Secretaria de Sauld, Mexico City CP 11340, Mexico. javiermancilla@hotmail.com.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Isibasi', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. isibasi@prodigy.net.mx.'}, {'ForeName': 'Constantino', 'Initials': 'C', 'LastName': 'López-Macías', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. constantino@sminmunologia.mx.'}]",Viruses,['10.3390/v11090868']
1704,31572073,"Effect of magnesium and lignocaine on post-craniotomy pain: A comparative, randomized, double blind, placebo-controlled study.","Background
Lignocaine and Magnesium have an analgesic action and reduce perioperative opioid requirements. We carried out this study to evaluate the effect of magnesium and lignocaine on postoperative pain as assessed using the visual analog scale (VAS) and fentanyl consumption. We also measured S-100 B levels and noted the side effect of drugs if any.
Materials and Methods
In this prospective preliminary study, 45 patients undergoing supratentorial craniotomy for tumor surgery were randomized to receive either lignocaine (group I-1.5 mg/kg bolus followed by 2 mg/kg/h infusion), saline (Group II) or magnesium (group III: bolus of 50 mg/kg followed by 25 mg/kg/hr) intraoperatively. The amount of fentanyl required, VAS over first 24 hours and any side effects were noted. S100 B levels were also measured to assess brain protective effect of these drugs, if any. Appropriate statistical tests were applied for analysis of data and a P value < 0.05 was considered statistically significant.
Results
None of the patient experienced any adverse hemodynamic effect intraoperatively secondary to the study drugs. The amount of intraoperative fentanyl consumption was comparable among the three groups. The mean VAS score was significantly less in group I and III [Group I (15.3 ± 6.0), Group II (24.8 ± 6.7), Group III (17.9 ± 7.6); ( P < 0.01)]. The fentanyl consumed in first 24 hours was significantly less in those patients who received lignocaine and magnesium [Group I (204.4 ± 136.4), Group II (383 ± 168.2), Group III (194 ± 148.9); ( P = 0.01)]. S100 value did not differ in the lignocaine and the saline group during the perioperative period. However, a significant decline was noted in the levels of S100 B in the magnesium group.
Conclusion
Intraoperative infusion of lignocaine and magnesium results in lower VAS score and decreases the postoperative opioid requirement in patients undergoing craniotomy for excision of supratentorial tumors.",2019,"The fentanyl consumed in first 24 hours was significantly less in those patients who received lignocaine and magnesium [Group I (204.4 ± 136.4), Group II (383 ± 168.2), Group III (194 ± 148.9);","['post-craniotomy pain', 'patients undergoing craniotomy for excision of supratentorial tumors', '45 patients undergoing supratentorial craniotomy for tumor surgery']","['saline (Group II) or magnesium', 'lignocaine', 'placebo', 'magnesium and lignocaine', 'Lignocaine and Magnesium', 'lignocaine and magnesium']","['postoperative pain', 'postoperative opioid requirement', 'brain protective effect', 'S-100 B levels', 'intraoperative fentanyl consumption', 'levels of S100 B', 'visual analog scale (VAS) and fentanyl consumption', 'lower VAS score', 'mean VAS score', 'S100 B levels']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0038874', 'cui_str': 'Supratentorial Tumors'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",45.0,0.0867016,"The fentanyl consumed in first 24 hours was significantly less in those patients who received lignocaine and magnesium [Group I (204.4 ± 136.4), Group II (383 ± 168.2), Group III (194 ± 148.9);","[{'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Mahajan', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajeeb Kumar', 'Initials': 'RK', 'LastName': 'Mishra', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Bhagya Ranjan', 'Initials': 'BR', 'LastName': 'Jena', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Kapoor', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Hemanshu', 'Initials': 'H', 'LastName': 'Prabhakar', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Girija Prasad', 'Initials': 'GP', 'LastName': 'Rath', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_837_18']
1705,31572074,Analgesia nociception index and hemodynamic changes during skull pin application for supratentorial craniotomies in patients receiving scalp block versus pin-site infiltration: A randomized controlled trial.,"Background
Noxious stimulation such as skull pin insertion for craniotomy elicits a significant hemodynamic response. Both regional analgesic techniques (pin-site infiltration [PSI] and scalp block [SB]), and systemic strategies (opioids, alpha-2 agonists, anesthetics, and beta-blockers) have shown to attenuate this response. Analgesia Nociception Index (ANI) provides objective information about the magnitude of nociception and adequacy of analgesia. This study compared ANI and hemodynamic changes in patients receiving local anesthetic SB versus PSI during skull pin application for craniotomy.
Materials and Methods
Sixty adult patients scheduled for elective supratentorial tumor surgery were randomly allocated to receive local anesthetic SB or PSI for skull pin insertion after the induction of anesthesia. Data regarding heart rate (HR), blood pressure (BP), and ANI were collected every minute for 5 min after the skull pin insertion beginning from the baseline.
Results
A significant difference was observed in ANI values between the SB (higher ANI) and the PSI groups during skull pin insertion, P < 0.001 and P = 0.003 for ANIi and ANIm, respectively. Similarly, a significant difference was seen in HR and BP both within and between the two groups during skull pin insertion ( P < 0.001 for both). The magnitude and duration of change were smaller in the SB group compared with the PSI group for the parameters studied. A strong negative linear correlation was noted between ANI and hemodynamic parameters.
Conclusions
The changes in HR, BP, and ANI were significantly less with local anesthetic SB compared with PSI during skull pin insertion in patients undergoing supratentorial craniotomy.",2019,"A significant difference was observed in ANI values between the SB (higher ANI) and the PSI groups during skull pin insertion, P < 0.001 and P = 0.003 for ANIi and ANIm, respectively.","['patients undergoing supratentorial craniotomy', 'patients receiving scalp block versus pin-site infiltration', 'Sixty adult patients scheduled for elective supratentorial tumor surgery', 'patients receiving local anesthetic SB versus PSI during skull pin application for craniotomy']","['regional analgesic techniques (pin-site infiltration [PSI] and scalp block [SB', 'skull pin application', 'local anesthetic SB or PSI', 'Analgesia Nociception Index (ANI', 'local anesthetic SB']","['Analgesia nociception index and hemodynamic changes', 'magnitude and duration of change', 'heart rate (HR), blood pressure (BP), and ANI', 'changes in HR, BP, and ANI', 'HR and BP', 'ANI values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0038874', 'cui_str': 'Supratentorial Tumors'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0037303', 'cui_str': 'Cranium'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique (procedure)'}, {'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0037303', 'cui_str': 'Cranium'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0326040', 'cui_str': 'Ani'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0326040', 'cui_str': 'Ani'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.130301,"A significant difference was observed in ANI values between the SB (higher ANI) and the PSI groups during skull pin insertion, P < 0.001 and P = 0.003 for ANIi and ANIm, respectively.","[{'ForeName': 'Kaushic A', 'Initials': 'KA', 'LastName': 'Theerth', 'Affiliation': 'Department of Neuroanaesthesia and Neurocritical Care, Rajagiri Hospital, Ernakulam, Kerala, India.'}, {'ForeName': 'Kamath', 'Initials': 'K', 'LastName': 'Sriganesh', 'Affiliation': 'Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Dhritiman', 'Initials': 'D', 'LastName': 'Chakrabarti', 'Affiliation': 'Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'K R Madhusudan', 'Initials': 'KRM', 'LastName': 'Reddy', 'Affiliation': 'Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'G S Umamaheswara', 'Initials': 'GSU', 'LastName': 'Rao', 'Affiliation': 'Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_812_18']
1706,31431236,"Quality of Life, Fatigue, and Sleep Problems in Pancreatic Cancer Patients—A Randomized Trial on the Effects of Exercise","BACKGROUND
Improving quality of life (QoL) is an important treatment goal in pancreatic cancer patients. Although the beneficial effects of exercise on QoL are well understood, few studies have investigated more aggressive cancers such as pancreatic cancer.
METHODS
Within a randomized trial, we assessed the efficacy of 6-month resistance training on physical functioning (primary outcome) and further QoL-related outcomes. 65 pancreatic cancer patients were assigned to home-based training, supervised training, or a usual care control group. Analysis-of-covariance models on changes from baseline to 6 and 3 months were ap- plied.
RESULTS
47 patients completed the intervention period. After 6 months, no effects of resistance training were observed. However, after 3 months, explorative analyses showed significant between-group mean differences (MD) in favor for resistance training for physical functioning (pooled group: MD=11.0; p=0.016; effect size[ES]=0.31), as well as for global QoL (MD=12.1; p=0.016; effect size=0.56), and other outcomes, such as sleep problems and fatigue. Multiple imputation analyses yielded similar results. Home-based and supervised training performed similarly.
CONCLUSION
This first randomized resistance training trial in pancreatic cancer patients indicated clinically relevant improve- ments in QoL after 3 but not after 6 months. Given the severity of pancreatic cancer, exercise recommendations may already commence at surgery.",2019,This first randomized resistance training trial in pancreatic cancer patients indicated clinically relevant improve- ments in QoL after 3 but not after 6 months.,"['pancreatic cancer patients', '65 pancreatic cancer patients', 'Pancreatic Cancer Patients', '47 patients completed the intervention period']","['Exercise', 'Home-based and supervised training performed similarly', 'home-based training, supervised training, or a usual care control group', 'resistance training']","['Quality of Life, Fatigue, and Sleep Problems', 'sleep problems and fatigue', 'resistance training']","[{'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",65.0,0.0849304,This first randomized resistance training trial in pancreatic cancer patients indicated clinically relevant improve- ments in QoL after 3 but not after 6 months.,"[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steindorf', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Germany'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Clauss', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Germany'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, German'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, German'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Herbolsheimer', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg, Germany'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute for Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, German'}, {'ForeName': 'Cornelia M', 'Initials': 'CM', 'LastName': 'Ulrich', 'Affiliation': 'Department of Population Health Sciences, Huntsman Cancer Institute and University of Utah, Salt Lake City, USA'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Division of Medical Oncology, National Center for Tumor Diseases and Heidelberg University Hospital, Heidelberg, Germany'}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0471']
1707,31834098,Biperiden Selectively Impairs Verbal Episodic Memory in a Dose- and Time-Dependent Manner in Healthy Subjects.,"PURPOSE/BACKGROUND
Biperiden is a muscarinic antagonist that produces memory impairments without impairing attention or motor functions in healthy subjects. It has been suggested that a biperiden-induced memory deficit could model age- and dementia-related memory impairments. The goal of the current study was to determine the dose- and time-dependent effects of biperiden on cognition in healthy volunteers.
METHODS/PROCEDURES
Twenty-one healthy volunteers participated in a placebo-controlled, 3-way, crossover study. After a baseline test, cognitive performance was tested at 3 time points after a single dose of biperiden 2 or 4 mg, or placebo. Episodic memory was measured using a 15-word verbal learning task (VLT). Furthermore, n-back tasks, a sustained attention to response task and a reaction time task were used, as well as subjective alertness and a side effects questionnaire. In addition, blood serum values and physiological measures were taken.
FINDINGS/RESULTS
Biperiden decreased the number of words recalled in immediate and delayed recall of the VLT 90 minutes after drug intake. A dose-dependent impairment was found for the delayed recall, whereas the immediate recall was equally impaired by the 2 doses. Biperiden did not affect the performance on the VLT 4 hours after administration. Performance in the n-back task and the sustained attention to response task were not affected by biperiden at any time point. Both doses were well tolerated as reported side effects were mild at Tmax and were minimal at the other time points.
IMPLICATIONS/CONCLUSIONS
Biperiden exerts effects on episodic memory without negatively affecting other cognitive performance and behavioral measures that were assessed in this study. The data provide further evidence that biperiden has selective effects on cognition, even after a high dose.",2020,Performance in the n-back task and the sustained attention to response task were not affected by biperiden at any time point.,"['Healthy Subjects', 'healthy subjects', 'Twenty-one healthy volunteers participated in a', 'healthy volunteers']","['placebo', '15-word verbal learning task (VLT', 'biperiden']","['number of words recalled in immediate and delayed recall', 'Verbal Episodic Memory', 'cognitive performance', 'blood serum values and physiological measures', 'Episodic memory']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0005578', 'cui_str': 'Biperiden'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",21.0,0.0815604,Performance in the n-back task and the sustained attention to response task were not affected by biperiden at any time point.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Borghans', 'Affiliation': 'From the Faculty of Psychology and Neuroscience, Department of Neuropsychology & Psychopharmacology, EURON, Maastricht University, the Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Sambeth', 'Affiliation': ''}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Blokland', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001157']
1708,29628825,Preperitoneal postcesarean section bupivacaine analgesia: Comparison between dexamethasone and dexmedetomidine as adjuvants.,"Background
The peritoneal wound is frequently neglected during laparotomy. The preperitoneal local anesthetics and many adjuvants were effective for postcesarean analgesia. Analgesia may involve somatic and autonomic components. The preperitoneal bupivacaine and the promising adjuvants dexamethasone or dexmedetomidine were compared in this study.
Patients and Methods
Sixty patients subjected to a cesarean section (CS) under general anesthesia divided into two groups using a bolus of preperitoneal bupivacaine 0.7 mg/kg with either 1ug/kg dexmedetomidine (Group P) or 8 mg dexamethasone (Group D). The time to the first analgesic request was the primary outcome.
Results
There was a significantly prolonged time to the first analgesic request in the Group P than the Group D and less required preperitoneal injections in the Group P, also pain assessed by Numerical Rating Scale (NRS) was lower in the Group P than the Group D after 6 h postoperatively up to 24 h.
Conclusions
Dexmedetomidine provided better analgesia than dexamethasone as an adjuvant to preperitoneal bupivacaine post-CS.",2018,"There was a significantly prolonged time to the first analgesic request in the Group P than the Group D and less required preperitoneal injections in the Group P, also pain assessed by Numerical Rating Scale (NRS) was lower in the Group P than the Group D after 6 h postoperatively up to 24 h.
Conclusions
Dexmedetomidine provided better analgesia than dexamethasone as an adjuvant to preperitoneal bupivacaine post-CS.",['Patients and Methods\n\n\nSixty patients subjected to a cesarean section (CS) under general anesthesia'],"['Dexmedetomidine', 'preperitoneal bupivacaine', 'dexamethasone and dexmedetomidine', 'dexmedetomidine', 'dexamethasone', 'preperitoneal bupivacaine 0.7 mg/kg with either 1ug/kg dexmedetomidine']","['prolonged time to the first analgesic request', 'pain assessed by Numerical Rating Scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}]",60.0,0.0608453,"There was a significantly prolonged time to the first analgesic request in the Group P than the Group D and less required preperitoneal injections in the Group P, also pain assessed by Numerical Rating Scale (NRS) was lower in the Group P than the Group D after 6 h postoperatively up to 24 h.
Conclusions
Dexmedetomidine provided better analgesia than dexamethasone as an adjuvant to preperitoneal bupivacaine post-CS.","[{'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Mazy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Gad', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bedairy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_450_17']
1709,29628826,"Dexmedetomidine vs morphine and midazolam in the prevention and treatment of delirium after adult cardiac surgery; a randomized, double-blinded clinical trial.","Background
The aim of this clinical study was to evaluate the efficacy of neurobehavioral, hemodynamics and sedative characteristics of dexmedetomidine compared with morphine and midazolam-based regimen after cardiac surgery at equivalent levels of sedation and analgesia in improving clinically relevant outcomes such as delirium.
Methods
Sixty patients were randomly allocated into one of two equal groups: group A = 30 patients received dexmedetomidine infusion (0.4-0.7 μg/kg/h) and Group B = 30 patients received morphine in a dose of 10-50 μg/kg/h as an analgesic with midazolam in a dose of 0.05 mg/kg up to 0.2 mg/kg as a sedative repeated as needed. Titration of the study medication infusions was conducted to maintain light sedation (Richmond agitation-sedation scale) (-2 to +1). Primary outcome was the prevalence of delirium measured daily through confusion assessment method for intensive care.
Results
Group A was associated with shorter length of mechanical ventilation, significant shorter duration of intensive care unit (ICU) stay ( P = 0.038), and lower risk of delirium following cardiac surgery compared to Group B. Group A showed statistically significant decrease in heart rate values 4 h after ICU admission ( P = 0.015) without significant bradycardia. Group A had lower fentanyl consumption following cardiac surgery compared to Group B.
Conclusion
Dexmedetomidine significantly reduced the length of stay in ICU in adult cardiac surgery with no significant reduction in the incidence of postoperative delirium compared to morphine and midazolam.",2018,"Group A had lower fentanyl consumption following cardiac surgery compared to Group B.
Conclusion
Dexmedetomidine significantly reduced the length of stay in ICU in adult cardiac surgery with no significant reduction in the incidence of postoperative delirium compared to morphine and midazolam.","['Methods\n\n\nSixty patients', 'delirium after adult cardiac surgery']","['Dexmedetomidine', 'midazolam', 'morphine', 'dexmedetomidine', 'dexmedetomidine infusion', 'morphine and midazolam']","['lower risk of delirium', 'shorter length of mechanical ventilation, significant shorter duration of intensive care unit (ICU) stay', 'fentanyl consumption', 'maintain light sedation (Richmond agitation-sedation scale', 'length of stay in ICU', 'heart rate values', 'incidence of postoperative delirium', 'prevalence of delirium measured daily through confusion assessment method for intensive care']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0085559'}]",60.0,0.501628,"Group A had lower fentanyl consumption following cardiac surgery compared to Group B.
Conclusion
Dexmedetomidine significantly reduced the length of stay in ICU in adult cardiac surgery with no significant reduction in the incidence of postoperative delirium compared to morphine and midazolam.","[{'ForeName': 'Tamer M Abdel', 'Initials': 'TMA', 'LastName': 'Azeem', 'Affiliation': 'Intensive care specialist at Intensive Care Department of Dar El Fouad Hospital, Ain-shams University, Cairo, Egypt.'}, {'ForeName': 'Nahed E', 'Initials': 'NE', 'LastName': 'Yosif', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ain-shams University, Cairo, Egypt.'}, {'ForeName': 'Adel M', 'Initials': 'AM', 'LastName': 'Alansary', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ain-shams University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim Mamdouh', 'Initials': 'IM', 'LastName': 'Esmat', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ain-shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed K', 'Initials': 'AK', 'LastName': 'Mohamed', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ain-shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_303_17']
1710,29628827,A prospective randomized study on the impact of low-dose dexamethasone on perioperative blood glucose concentrations in diabetics and nondiabetics.,"Background
Dexamethasone is a potent corticosteroid when administered alone or in combination alone has proven efficacious in preventing nausea and vomiting (PONV) perioperatively. However, the administration of even a single dose has been associated with hyperglycemia. This is the first study that evaluates the effect of two low-doses of dexamethasone (4 and 8 mg) on blood glucose concentrations among diabetics and nondiabetics in patients who have received spinal anesthesia.
Materials and Methods
After obtaining ethical clearance and patient consent, 180 American Society of Anesthesiologists 1-3 patients undergoing the elective infraumbilical surgeries under spinal anesthesia aged between 18 and 70 years were included in this study. Ninety diabetic patients were allotted to the diabetic group (DM), and ninety nondiabetic patients were allotted to the nondiabetic group (ND). Group DM was divided into three subgroups DM0, DM4, and DM8. Group ND was divided into three subgroups ND0, ND4, and ND8. The patients in groups DM0 and ND0 served as controls. The patients in groups DM4 and ND4 received 4 mg dexamethasone. The patients in groups DM8 and ND8 received 8 mg dexamethasone. The blood glucose concentrations were monitored at 0 (baseline), 1, 2, 3, 4, 5, 6, and 8 h after giving the drug.
Results
The baseline blood glucose values were higher in diabetics compared to nondiabetics (128.57 ± 22.26 vs 94.99 ± 12.82 mg/dL). There was a statistically significant increase in blood glucose concentrations in both diabetics and nondiabetics who received dexamethasone. The rise of blood glucose from baseline was similar in both diabetics and nondiabetics.
Conclusion
The maximum rise in blood glucose was in the range of 40-45 mg/dl in the patients who received dexamethasone. The clinician should use his clinical judgment before administering dexamethasone for PONV prophylaxis/treatment.",2018,The maximum rise in blood glucose was in the range of 40-45 mg/dl in the patients who received dexamethasone.,"['Ninety diabetic patients were allotted to the diabetic group (DM), and ninety nondiabetic patients were allotted to the nondiabetic group (ND', '180 American Society of Anesthesiologists 1-3 patients undergoing the elective infraumbilical surgeries under spinal anesthesia aged between 18 and 70 years', 'diabetics and nondiabetics', 'diabetics and nondiabetics in patients who have received spinal anesthesia']","['Dexamethasone', 'dexamethasone']","['nausea and vomiting (PONV) perioperatively', 'perioperative blood glucose concentrations', 'blood glucose concentrations', 'rise of blood glucose', 'baseline blood glucose values', 'maximum rise in blood glucose']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",90.0,0.0248469,The maximum rise in blood glucose was in the range of 40-45 mg/dl in the patients who received dexamethasone.,"[{'ForeName': 'Athul M', 'Initials': 'AM', 'LastName': 'Purushothaman', 'Affiliation': 'Department of Anaesthesiology, Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}, {'ForeName': 'Vinayak Seenappa', 'Initials': 'VS', 'LastName': 'Pujari', 'Affiliation': 'Department of Anaesthesiology, Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}, {'ForeName': 'Nalini B', 'Initials': 'NB', 'LastName': 'Kadirehally', 'Affiliation': 'Department of Anaesthesiology, Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}, {'ForeName': 'Yatish', 'Initials': 'Y', 'LastName': 'Bevinaguddaiah', 'Affiliation': 'Department of Anaesthesiology, Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}, {'ForeName': 'Pratheek R', 'Initials': 'PR', 'LastName': 'Reddy', 'Affiliation': 'Department of Anaesthesiology, Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_409_17']
1711,29618280,Progressive resistance exercise training and changes in resting-state functional connectivity of the caudate in persons with multiple sclerosis and severe fatigue: A proof-of-concept study.,"Fatigue is one of the most disabling symptoms of multiple sclerosis (MS). While progressive resistance training (PRT) has been shown to reduce fatigue in persons with MS, it is not clear why these reductions occur. One hypothesis is that PRT may induce functional changes to the caudate, a region highly implicated in MS fatigue. The aim of the current study was to study the effects of PRT on overall fatigue impact and resting-state functional connectivity of the caudate in persons with MS reporting severe fatigue. Participants were semi-randomly assigned to either a 16-week home-based PRT ( n = 5) or stretching control ( n = 5) condition. Both groups demonstrated reductions in overall fatigue impact (main effect of time: F = .84, d = .65). Significant group × time interactions were found, with the PRT group demonstrating post-training increases in functional connectivity between the caudate and left inferior parietal ( F = 66.0, p < .001), bilateral frontal (both p < .001), and right insula ( F = 21.8, p = .002) regions compared to the stretching group. Furthermore, greater post-training increases in functional connectivity between the caudate and left inferior parietal region were associated with greater decreases in cognitive fatigue ( r = -.52) specifically. This study provides initial evidence for the caudate as a potential neural substrate for the beneficial effects of PRT on fatigue in persons with MS.",2020,"Both groups demonstrated reductions in overall fatigue impact (main effect of time: F = .84, d = .65).","['persons with MS reporting severe fatigue', 'persons with multiple sclerosis and severe fatigue', 'persons with MS']","['16-week home-based PRT (n\u2009=\u20095) or stretching control', 'PRT', 'Progressive resistance exercise training', 'progressive resistance training (PRT']","['bilateral frontal', 'functional connectivity', 'cognitive fatigue', 'overall fatigue impact', 'overall fatigue impact and resting-state functional connectivity']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",,0.0214287,"Both groups demonstrated reductions in overall fatigue impact (main effect of time: F = .84, d = .65).","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Akbar', 'Affiliation': ""School of Rehabilitation Therapy, Faculty of Health Sciences, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Wylie', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Strober', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Goverover', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Genova', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, East Hanover, New Jersey, USA.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2018.1449758']
1712,29416449,"Effect of intravenous lidocaine on the incidence of postextubation laryngospasm: A double-blind, placebo-controlled randomized trial.","Objectives
The study aimed to test the effect of intraoperative intravenous (IV) lidocaine on the incidence of postextubation laryngospasm in adult patients.
Methods
The prospective randomized clinical trial was conducted at tertiary care hospital in Riyadh, between January and December 2012. Seventy-two patients undergoing laparoscopic cholecystectomy were randomly assigned to receive either placebo ( n = 36) or IV lidocaine ( n = 36), 1 mg/kg bolus after desflurane was discontinued. Laryngospasm was graded from 0 to 3 based on the absence or presence of signs and the severity of postextubation laryngospasm.
Results
The study was terminated early by the data monitoring committee because of safety concerns due to an increased incidence of postextubation laryngospasm. Patient demographics were similar for both groups. The incidence of postextubation laryngospasm was 19.5% in the placebo group and 0% in the treatment (lidocaine) group; this difference was statistically significant ( P = 0.017; 95% confidence interval, 4.6% to 36.0%).
Conclusions
The cause of laryngospasm in our study was most likely the rapid increase in the concentration of inspired desflurane, which might have caused airway irritation. Therefore, we believe that pretreating patients at risk of developing laryngospasm with IV lidocaine could be effective.",2018,"The incidence of postextubation laryngospasm was 19.5% in the placebo group and 0% in the treatment (lidocaine) group; this difference was statistically significant ( P = 0.017; 95% confidence interval, 4.6% to 36.0%).
","['tertiary care hospital in Riyadh, between January and December 2012', 'adult patients', 'Seventy-two patients undergoing laparoscopic cholecystectomy']","['lidocaine', 'intraoperative intravenous (IV) lidocaine', 'IV lidocaine', 'placebo']",['incidence of postextubation laryngospasm'],"[{'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}]",72.0,0.339505,"The incidence of postextubation laryngospasm was 19.5% in the placebo group and 0% in the treatment (lidocaine) group; this difference was statistically significant ( P = 0.017; 95% confidence interval, 4.6% to 36.0%).
","[{'ForeName': 'Khalid Ibrahim', 'Initials': 'KI', 'LastName': 'Aljonaieh', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Khalid University Hospital, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_440_17']
1713,29416451,"Which is better for pain reduction during transrectal ultrasound-guided biopsy of the prostate: Intravenous diazepam, local periprostatic nerve block, or combination? controlled randomized study.","Background
Transrectal ultrasound-guided prostate biopsy (TRUSPB) is considered the procedure of choice for the diagnosis of prostate cancer. Men undergoing this biopsy experience high psychological stress. Different studies recommend techniques as sedation, lidocaine gel intrarectally, periprostatic nerve block alone, or nitrous oxide inhalation as effective methods of analgesia during procedural-related pain or discomfort. We evaluated three techniques for pain relief during TRUSPB and evaluated if there was any increase in the incidence of complications when employing either technique.
Setting
Assiut University Hospital, Assiut, Egypt.
Methods
Three hundred patients of age 43-92-year-old underwent TRUSPBs. Patients were allocated randomly into three equal groups to receive intravenous (IV) diazepam 5 mg slowly (Group I), bilateral periprostatic nerve block by 10 ml of 1% lidocaine solution injected under ultrasound guidance (Group II), or combined IV diazepam and the periprostatic nerve block (Group III).
Results
The mean pain score was 4.95 for patients in Group I, 4.15 for patients in Group II, and 2.18 for patients in Group III with statistically significant findings ( F = 120.27, P < 0.001). TRUSPB under combined IV sedation and local anesthesia had no significant increase in the incidence of complications.
Conclusions
Patients should have analgesia during TRUSPB to decrease the procedure pain and to improve tolerance permitting proper aiming for biopsy cores without increasing the patient distress. The combined IV sedation and local periprostatic nerve block are efficient in controlling and limiting pain better than employing each technique alone with no significant increase in complications incidence.",2018,The combined IV sedation and local periprostatic nerve block are efficient in controlling and limiting pain better than employing each technique alone with no significant increase in complications incidence.,"['Methods\n\n\nThree hundred patients of age 43-92-year-old underwent TRUSPBs', 'Men undergoing this biopsy experience high psychological stress']","['nitrous oxide inhalation', 'lidocaine', '\n\n\nTransrectal ultrasound-guided prostate biopsy (TRUSPB', 'diazepam', 'intravenous (IV) diazepam', 'bilateral periprostatic nerve block by 10 ml of 1% lidocaine solution injected under ultrasound guidance (Group II), or combined IV diazepam and the periprostatic nerve block (Group III', 'TRUSPB']","['pain reduction', 'mean pain score', 'incidence of complications', 'complications incidence', 'pain relief']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",300.0,0.0612281,The combined IV sedation and local periprostatic nerve block are efficient in controlling and limiting pain better than employing each technique alone with no significant increase in complications incidence.,"[{'ForeName': 'Haisam', 'Initials': 'H', 'LastName': 'Atta', 'Affiliation': 'Department of Radiology, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University Hospital, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Shalaby', 'Affiliation': 'Department of Urology, Faculty of Medicine, Assiut University Hospital, Assiut University, Assiut, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_141_17']
1714,29416452,Comparative study of anatomical landmark-guided versus ultrasound-guided suprascapular nerve block in chronic shoulder pain.,"Background
Suprascapular nerve block (SSNB) is an effective method for the treatment of shoulder disorders. The present study was conducted to evaluate and compare the effectiveness of SSNB under ultrasonographic guidance with anatomical landmark-guided (LMG) technique in the treatment of chronic shoulder pain.
Materials and Methods
A total of fifty patients with shoulder pain were enrolled in the present prospective randomized study. Patients in Group I ( n = 25) received SSNB using the anatomical LMG as technique described by Dangoisse, in whom a total of 6 ml of drug (5 ml of 0.25% bupivacaine and 40 mg methylprednisolone) was injected. Group II patients ( n = 25) were given SSNB using the ultrasound guidance with the same amount of drug. Pain was measured using visual analog scale (VAS), range of motion and Shoulder Pain and Disability Index (SPADI) were recorded. Observations were recorded before the block, immediately after the block, and 1 and 4 weeks after the block.
Results
There was no statistically significant difference between the VAS score, range of motion and SPADI before the procedure ( P > 0.05) in both the groups. Both the groups showed statistically similar improvement of VAS, range of motion and SPADI at 4-week ( P > 0.05) follow-up. In Group I, VAS decreased from baseline value of 6.64 ± 1.50-2.04 ± 0.94 at 4 weeks ( P < 0.001). In Group II, the VAS decreased from 6.92 ± 1.00 to 1.84 ± 1.03 at 4 weeks ( P < 0.01).
Conclusion
In our study, both the techniques have produced comparable relief of pain, improvement in shoulder movement, and decreased SPADI 4 weeks after the block.",2018,"Both the groups showed statistically similar improvement of VAS, range of motion and SPADI at 4-week","['fifty patients with shoulder pain', 'chronic shoulder pain']","['\n\n\nSuprascapular nerve block (SSNB', 'anatomical landmark-guided versus ultrasound-guided suprascapular nerve block', 'SSNB', 'bupivacaine and 40 mg methylprednisolone', 'SSNB under ultrasonographic guidance with anatomical landmark-guided (LMG) technique']","['VAS, range of motion and SPADI', 'visual analog scale (VAS), range of motion and Shoulder Pain and Disability Index', 'Pain', 'VAS', 'VAS score, range of motion and SPADI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve (procedure)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.0397711,"Both the groups showed statistically similar improvement of VAS, range of motion and SPADI at 4-week","[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Kamal', 'Affiliation': 'Department of Anaesthesia and Critical Care, PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Dahiya', 'Affiliation': 'Department of Anaesthesia and Critical Care, PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Roop', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Orthopaedics, PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Saini', 'Affiliation': 'Department of Anaesthesia and Critical Care, PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Susheela', 'Initials': 'S', 'LastName': 'Taxak', 'Affiliation': 'Department of Anaesthesia and Critical Care, PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Saloni', 'Initials': 'S', 'LastName': 'Kapoor', 'Affiliation': 'Department of Anaesthesia, All India Institute of Medical Sciences, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_123_17']
1715,31623758,Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI.,"BACKGROUND
Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse.
OBJECTIVES
This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI.
METHODS
The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding.
RESULTS
Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; p interaction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; p interaction = 0.754).
CONCLUSIONS
Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435).",2019,There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; p interaction = 0.031).,"['Patients\xa0Undergoing Multivessel PCI', 'patients with multivessel PCI', 'patients who undergo multivessel percutaneous coronary intervention (PCI', 'comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen']","['experimental strategy (1-month dual antiplatelet therapy [DAPT', 'ticagrelor monotherapy', 'Ticagrelor\xa0Monotherapy']","['balance ischemic and bleeding risks', 'risk of Bleeding Academic Research Consortium type 3 or 5 bleeding', 'composite of all-cause death or new Q-wave myocardial infarction', 'risk of ischemic and bleeding events', 'Efficacy and Safety', 'Bleeding Academic Research Consortium type 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035168'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3576.0,0.0994418,There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; p interaction = 0.031).,"[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Magro', 'Affiliation': 'TweeSteden Ziekenhuis, Tilburg, the Netherlands.'}, {'ForeName': 'Saqib', 'Initials': 'S', 'LastName': 'Chowdhary', 'Affiliation': 'Manchester University Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'University Heart Center Lübeck, Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine) and German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Lübeck, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zweiker', 'Affiliation': 'Medical University Hospital Graz, Graz, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ong', 'Affiliation': 'Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Michael Mundt', 'Initials': 'MM', 'LastName': 'Ottesen', 'Affiliation': 'Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Cardialysis B.V., Rotterdam, the Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Royal Blackburn Hospital, Blackburn, United Kingdom.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Clinical Research, Morges, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen and Kerckhoff Heart and Thorax Center, University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Cardialysis B.V., Rotterdam, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Rangueil Hospital, Toulouse, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.08.997']
1716,31623762,Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events.,"BACKGROUND
Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes to worse outcome.
OBJECTIVES
The purpose of this study was to assess the effectiveness of an implanted cardiac monitor with real-time alarms for abnormal ST-segment shifts to reduce pre-hospital delay during ACS events.
METHODS
In the ALERTS (AngeLmed Early Recognition and Treatment of STEMI) pivotal study, subjects at high risk for recurrent ACS events (n = 907) were randomized to control (Alarms OFF) or treatment groups for 6 months, after which alarms were activated in all subjects (Alarms ON). Emergency department (ED) visits with standard-of-care cardiac test results were independently adjudicated as true- or false-positive ACS events. Alarm-to-door (A2D) and symptom-to-door (S2D) times were calculated for true-positive ACS ED visits triggered by 3 possible prompts: alarm only, alarms + symptoms, or symptoms only.
RESULTS
The Alarms ON group showed reduced delays, with 55% (95% confidence interval [CI]: 46% to 63%) of ED visits for ACS events <2 h compared with 10% (95% CI: 2% to 27%) in the Alarms OFF group (p < 0.0001). Results were similar when restricted to myocardial infarction (MI) events. Median pre-hospital delay for MI was 12.7 h for Alarms OFF and 1.6 h in Alarms ON subjects (p < 0.0089). Median A2D delay was 1.4 h for asymptomatic MI. Median S2D delay for symptoms-only MI (no alarm) in Alarms ON was 4.3 h.
CONCLUSIONS
Intracardiac monitoring with real-time alarms for ST-segment shift that exceeds a subject's self-normative ischemia threshold level significantly reduced the proportion of pre-hospital delays >2 h for ACS events, including asymptomatic MI, compared with symptoms-only ED visits in Alarms OFF. (AngeLmed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118).",2019,Median pre-hospital delay for MI was 12.7 h for Alarms OFF and 1.6 h in Alarms,"['Patients', 'subjects at high risk for recurrent ACS events (n\xa0=\xa0907) were randomized to control ']",[],"['Median A2D delay', 'Alarm-to-door (A2D) and symptom-to-door (S2D) times', 'myocardial infarction (MI) events', 'Median S2D delay for symptoms-only MI (no alarm', 'Median pre-hospital delay for MI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}, {'cui': 'C0557698', 'cui_str': 'Door (physical object)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",907.0,0.0265239,Median pre-hospital delay for MI was 12.7 h for Alarms OFF and 1.6 h in Alarms,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Holmes', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: holmes.david@mayo.edu.'}, {'ForeName': 'Mitchell W', 'Initials': 'MW', 'LastName': 'Krucoff', 'Affiliation': 'Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Mullin', 'Affiliation': 'North American Science Associates, Inc., Toledo, Ohio.'}, {'ForeName': 'Ghiath', 'Initials': 'G', 'LastName': 'Mikdadi', 'Affiliation': 'Heart Clinic of Hammond, Hammond, Louisiana.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Presser', 'Affiliation': 'Innovative Medical Research LLC, Covington, Louisiana.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wohns', 'Affiliation': 'Division of Cardiovascular Medicine, Grand Rapids, Michigan.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Banner Heart Hospital, Mesa, Arizona.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Ciuffo', 'Affiliation': 'Sentara Healthcare Norfolk, Norfolk, Virginia.'}, {'ForeName': 'Arthur L', 'Initials': 'AL', 'LastName': 'Eberly', 'Affiliation': 'Greenville Memorial Hospital, Greenville, South Carolina.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Iteld', 'Affiliation': 'Louisiana Heart Center, Hammond, Louisiana.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Fischell', 'Affiliation': 'Angel Medical Systems, Eatontown, New Jersey.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Fischell', 'Affiliation': 'Angel Medical Systems, Eatontown, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Keenan', 'Affiliation': 'Angel Medical Systems, Eatontown, New Jersey.'}, {'ForeName': 'M Sasha', 'Initials': 'MS', 'LastName': 'John', 'Affiliation': 'Angel Medical Systems, Eatontown, New Jersey.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.084']
1717,29788815,Effect of Magnesium Loading Dose on Insulin Resistance in Patients With Stress-Induced Hyperglycemia: A Randomized Clinical Trial.,"OBJECTIVES
There is currently no evidence that whether magnesium supplementation would improve stress-induced hyperglycemia (SIH) in critically ill patients. In this study, effects of magnesium loading dose on insulin resistance (IR) indices were evaluated in critically ill patients without diabetes having SIH.
METHODS
Seventy critically ill patients with SIH were assigned to receive a loading dose of magnesium (7.5 g of magnesium sulfate in 500 mL normal saline as intravenous infusion over an 8-hour period) or placebo. Changes in baseline of serum and intracellular magnesium and serum adiponectin (AD) levels, homeostasis model assessment of IR (HOMA-IR), and HOMA-AD ratio were assessed in this study.
RESULTS
Serum and intracellular magnesium levels increased significantly in patients in the magnesium group ( P < .001). At day 3, there were significant differences between the magnesium group and the placebo group in the mean changes from baseline in the HOMA (between-group difference: -0.11; 95% confidence interval [CI]: -0.19 to -0.01; P = .02), the AD (between-group difference: 0.94; 95% CI: 0.41-1.48; P = .04), and the HOMA-AD ratio (between-group difference: -0.03; 95% CI: -0.04 to -0.01; P < .001).
CONCLUSION
In the present study, a single-loading dose of intravenous magnesium improved IR indices in critically ill patients with SIH.",2020,"the AD (between-group difference: 0.94; 95% CI: 0.41-1.48; P = .04), and the HOMA-AD ratio (between-group difference: -0.03; 95% CI: -0.04 to -0.01; P < .001).
","['Seventy critically ill patients with SIH', 'critically ill patients with SIH', 'critically ill patients without diabetes having SIH', 'critically ill patients', 'Patients With Stress-Induced Hyperglycemia']","['magnesium (7.5 g of magnesium sulfate in 500 mL normal saline', 'placebo', 'Magnesium Loading Dose', 'magnesium loading', 'magnesium supplementation', 'intravenous magnesium', 'magnesium']","['insulin resistance (IR) indices', 'Serum and intracellular magnesium levels', 'Insulin Resistance', 'baseline of serum and intracellular magnesium and serum adiponectin (AD) levels, homeostasis model assessment of IR (HOMA-IR), and HOMA-AD ratio', 'HOMA', 'HOMA-AD ratio', 'stress-induced hyperglycemia (SIH']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856953', 'cui_str': 'Stress induced hyperglycaemia'}]","[{'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C1096534', 'cui_str': 'Providing magnesium based on suboptimal food or fluid intake, iatrogenic deficiency or medical diagnosis. (Source: IDNT Reference Manual, edition 4; ISBN #978-0-88091-467-3)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0373675', 'cui_str': 'Magnesium measurement (procedure)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0856953', 'cui_str': 'Stress induced hyperglycaemia'}]",70.0,0.704471,"the AD (between-group difference: 0.94; 95% CI: 0.41-1.48; P = .04), and the HOMA-AD ratio (between-group difference: -0.03; 95% CI: -0.04 to -0.01; P < .001).
","[{'ForeName': 'Zinat', 'Initials': 'Z', 'LastName': 'Heidary', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Intensive Care Unit, Imam Khomeini Hospital, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad-Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Department of Intensive Care Unit, Imam Khomeini Hospital, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of intensive care medicine,['10.1177/0885066618777431']
1718,29749716,"Comparative Randomized, Single-Dose, Two-Way Crossover Open-Label Study to Determine the Bioequivalence of Two Formulations of Dalfampridine Tablets.","Dalfampridine is a medication that is approved by the US Food and Drug Administration to improve walking impairments in patients with multiple sclerosis (MS). The branded dalfampridine is enormously expensive; hence, the availability of generic dalfampridine will provide better access to the medication, especially for uninsured patients with MS. Bioequivalence studies are demanded by the regulatory authorities to allow the marketing of new generics of dalfampridine. The aim of this study was to assess the bioavailability of the generic (test) and branded (reference) formulations of 10 mg dalfampridine of extended-release tablets after oral administration to healthy adults under fed conditions. The current report methodology was based on a comparative, randomized, single-dose, 2-way crossover open-label study design. Twenty-seven subjects were given a single dose of the test dalfampridine tablet and completed the clinical study. The pharmacokinetic parameters C max and AUC 0→t, K el , AUC 0→∞ , t max , and t 1/2el were estimated to prove bioequivalence. The confidence intervals for the log-transformed test/reference ratios for dalfampridine 100.96% (97.09%-104.97%) and 99.77% (95.81%-103.87%) for C max and AUC 0→∞ , respectively, were within the allowed limit specified by the regulatory authorities (80%-125%). Hence, clinically, the test tablet can be prescribed as an alternative to the reference for the indication of improving walking impairments in patients with MS.",2019,Bioequivalence studies are demanded by the regulatory authorities to allow the marketing of new generics of dalfampridine.,"['uninsured patients with MS', 'patients\xa0with multiple\xa0sclerosis\xa0(MS', 'healthy adults under fed conditions', 'patients\xa0with MS', 'Twenty-seven subjects']","['dalfampridine tablet', 'Dalfampridine Tablets', 'Dalfampridine', 'dalfampridine of extended-release tablets']","['pharmacokinetic parameters C max and AUC 0→t, K el , AUC 0→∞ , t max , and t 1/2el', 'bioavailability of the generic (test) and branded (reference) formulations']","[{'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4319602', 'cui_str': '27'}]","[{'cui': 'C0000477', 'cui_str': 'fampridine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",27.0,0.0266227,Bioequivalence studies are demanded by the regulatory authorities to allow the marketing of new generics of dalfampridine.,"[{'ForeName': 'Abdel Qader', 'Initials': 'AQ', 'LastName': 'Al Bawab', 'Affiliation': 'Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan.'}, {'ForeName': 'Bashar A', 'Initials': 'BA', 'LastName': 'Alkhalidi', 'Affiliation': 'School of Pharmacy, The University of Jordan, Amman, Jordan.'}, {'ForeName': ""Esra'a"", 'Initials': 'E', 'LastName': 'Albarahmieh', 'Affiliation': 'School of Applied Medical Sciences, German Jordanian University, Amman, Jordan.'}, {'ForeName': 'Sami M A', 'Initials': 'SMA', 'LastName': 'Qassim', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammad A D', 'Initials': 'MAD', 'LastName': 'Al-Saifi', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.574']
1719,29665714,A Customized Intervention for Dementia Caregivers: A Quasi-Experimental Design.,"Objective: The aim of this study is to test the effects of a customized intervention on distress among caregivers of persons with dementia (PWD) using a quasi-experimental design. Method: Fifty-one spouse caregivers in the experimental group and 51 in the control group participated in the study. The effects of the intervention were examined by comparing caregivers' responses with questionnaires at pre-intervention baseline (T0) and immediately after intervention (T1). Differences were quantified using repeated-measures ANOVA. Results: The analyses indicated a stabilizing effect of the intervention on caregivers' perceptions of PWD's daily functioning, self-esteem related to caregiving, quality of family support, and feeling of distress. Linear increases were observed regarding sense of preparedness and impact on daily routine, while no differences (interaction and linear effects) were observed for degree of self-efficacy, depression, impact on finances, or self-rated health. Conclusion: These findings show a preliminary efficacy of the intervention proposed in this study to prevent the exacerbation of caregivers' distress.",2019,"Linear increases were observed regarding sense of preparedness and impact on daily routine, while no differences (interaction and linear effects) were observed for degree of self-efficacy, depression, impact on finances, or self-rated health. ","['caregivers of persons with dementia (PWD', 'Method: Fifty-one spouse caregivers in the experimental group and 51 in the control group participated in the study', 'Dementia Caregivers']",['customized intervention'],"['degree of self-efficacy, depression, impact on finances, or self-rated health', ""caregivers' perceptions of PWD's daily functioning, self-esteem related to caregiving, quality of family support, and feeling of distress"", 'sense of preparedness and impact on daily routine']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0087015', 'cui_str': 'Spouse Caregivers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0150232', 'cui_str': 'Family support (regime/therapy)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]",51.0,0.0219824,"Linear increases were observed regarding sense of preparedness and impact on daily routine, while no differences (interaction and linear effects) were observed for degree of self-efficacy, depression, impact on finances, or self-rated health. ","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Wawrziczny', 'Affiliation': ""1 Laboratory SCALab, UMR CNRS 9193, University of Lille, Villeneuve d'Ascq, France.""}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Larochette', 'Affiliation': ""1 Laboratory SCALab, UMR CNRS 9193, University of Lille, Villeneuve d'Ascq, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Papo', 'Affiliation': ""1 Laboratory SCALab, UMR CNRS 9193, University of Lille, Villeneuve d'Ascq, France.""}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Constant', 'Affiliation': ""1 Laboratory SCALab, UMR CNRS 9193, University of Lille, Villeneuve d'Ascq, France.""}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Ducharme', 'Affiliation': '2 Institut Universitaire de Gériatrie de Montréal, Canada.'}, {'ForeName': 'Marie-Jeanne', 'Initials': 'MJ', 'LastName': 'Kergoat', 'Affiliation': '2 Institut Universitaire de Gériatrie de Montréal, Canada.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Pasquier', 'Affiliation': '4 Department of Neurology, Memory Research and Resources Clinic at the University Hospital of Lille, University of Lille, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Antoine', 'Affiliation': ""1 Laboratory SCALab, UMR CNRS 9193, University of Lille, Villeneuve d'Ascq, France.""}]",Journal of aging and health,['10.1177/0898264318770056']
1720,29416463,Effect of extended infusion of meropenem and nebulized amikacin on Gram-negative multidrug-resistant ventilator-associated pneumonia.,"Background
Ventilator-associated pneumonia (VAP) due to multidrug-resistant organisms (MDROs) is associated with a significant mortality in the Intensive Care Unit (ICU). The aim of this study was to compare the efficacy and safety of extended infusion of meropenem and nebulized amikacin on VAP caused by Gram-negative MDRO versus intravenous (IV) meropenem and amikacin alone.
Methodology
A randomized nonblinded controlled trial was performed on ninety patients with VAP. Patients were randomized into three equal groups: Group I received IV amikacin 20 mg/kg/24 h and meropenem 2 g over 30 min/8 h. Group II received the same as Group I in addition to nebulized amikacin 25 mg/kg/day every 8 h. Group III received IV amikacin 20 mg/kg/24 h, nebulized amikacin 25 mg/kg/day every 8 h, and meropenem 2 g diluted in 240 ml normal saline over 3 h/8 h. The primary outcome was the clinical outcome of VAP. Secondary outcomes were microbiological outcome, VAP-related mortality, duration of MV, ICU stay, and nephrotoxicity.
Results
Group II and Group III compared to Group I showed higher incidence of clinical cure (53.33% in Group II and 66.67% in Group III vs. 26.67% in Group I, P = 0.007). Group II compared to Group I showed significant reduction in ventilator days (5.32 ± 1.86 vs. 7.3 ± 2.1 days, respectively, P < 0.001) and reduction in ICU days (11.87 ± 2.6 vs. 15.3 ± 3.1 days, respectively, P < 0.001). Group III compared to Group II showed significant reduction in ventilator days (4.22 ± 1.32 vs. 5.32 ± 1.86, respectively, P = 0.011) and highly significant reduction in ICU days (9.21 ± 1.17 vs. 11.87 ± 2.6, respectively, P < 0.001). All groups were comparable as regards nephrotoxicity or mortality.
Conclusions
Adding nebulized amikacin to systemic antibiotics in patients with VAP caused by Gram-negative MDRO may offer efficacy benefits, and the use of extended infusions of meropenem could improve the clinical outcomes in critically ill populations.",2018,"I showed higher incidence of clinical cure (53.33% in Group II and 66.67% in Group III vs. 26.67% in Group I, P = 0.007).","['Gram-negative multidrug-resistant ventilator-associated pneumonia', 'ninety patients with VAP', 'patients with VAP']","['meropenem 2 g diluted in 240 ml normal saline', 'nebulized amikacin', 'IV amikacin 20 mg/kg/24 h and meropenem', 'amikacin 20 mg/kg/24 h, nebulized amikacin', 'meropenem', 'meropenem and nebulized amikacin', 'intravenous (IV) meropenem and amikacin alone']","['nephrotoxicity or mortality', 'clinical outcome of VAP', 'microbiological outcome, VAP-related mortality, duration of MV, ICU stay, and nephrotoxicity', 'ventilator days', 'efficacy and safety', 'clinical cure']","[{'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0599918', 'cui_str': 'Nephrotoxicity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",90.0,0.069142,"I showed higher incidence of clinical cure (53.33% in Group II and 66.67% in Group III vs. 26.67% in Group I, P = 0.007).","[{'ForeName': 'Mona Ahmed', 'Initials': 'MA', 'LastName': 'Ammar', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Abdalla', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_148_17']
1721,29416464,Impact of duloxetine and dexamethasone for improving postoperative pain after laparoscopic gynecological surgeries: A randomized clinical trial.,"Background
Patients' surgical experiences are influenced by their perception of pain management. Duloxetine (Dulox) and dexamethasone (Dex) are used in multimodal analgesia to reduce opioid use and side effects. Dulox is a selective serotonin and norepinephrine reuptake inhibitor and has efficacy in chronic pain conditions. Dex enhances postoperative (PO) analgesia and reduces PO nausea and vomiting (PONV).
Methods
Seventy-five female patients were randomly allocated into one of three equal groups. GI received Dulox 60 mg orally and 100 ml 0.9% sodium chloride (normal saline [NS]) intravenous infusion (IVI) over 15 min, GII: received as GI except Dex 0.1 mg/kg was mixed with NS and GIII received identical placebo for Dulox capsule and Dex IVI, 2 h preoperatively. Patients' vitals, visual analog scale (VAS), and sedation score were assessed at 30 min, 1 h, 2 h, 6 h, and 12 h postoperatively. Total pethidine requirements, plasma cortisol, PONV, and patients satisfaction were recorded.
Results
PO time for 1 st rescue analgesic was significantly high in GI and GII compared to GIII and in GII compared to GI. There was a significant less VAS score, heart rate, mean arterial pressure, and a high sedation score in GI and GII compared to GIII at 30 min, 1, 2, and 6 h postoperatively. Total pethidine requirements were significantly less in GI and GII compared to GIII 12 h postoperatively. There was a significant reduction in the 2 h PO serum cortisol (μg/dl) and a significant increase in the PO patients satisfaction score in GI and GII compared to GIII. PONV was decreased significantly in GII compared to GI and GIII.
Conclusion
The use of oral Dulox 60 mg combined with Dex 0.1 mg/kg IVI is more effective than oral Dulox 60 mg alone, 2 h preoperatively, for improving PO pain by reducing the requirements for rescue analgesia and PONV.",2018,"Results
PO time for 1 st rescue analgesic was significantly high in GI and GII compared to GIII and in GII compared to GI.","['Methods\n\n\nSeventy-five female patients', 'after laparoscopic gynecological surgeries']","['Dulox 60 mg orally and 100 ml 0.9% sodium chloride (normal saline [NS]) intravenous infusion (IVI) over 15 min, GII: received as GI except Dex 0.1 mg/kg was mixed with NS and GIII received identical placebo', 'duloxetine and dexamethasone', 'Duloxetine (Dulox) and dexamethasone (Dex', 'oral Dulox 60 mg combined with Dex 0.1 mg/kg IVI']","['postoperative pain', 'Dex enhances postoperative (PO) analgesia and reduces PO nausea and vomiting (PONV', ""Patients' vitals, visual analog scale (VAS), and sedation score"", 'VAS score, heart rate, mean arterial pressure, and a high sedation score in GI and GII', 'PONV', 'Total pethidine requirements', 'PO patients satisfaction score', '2 h PO serum cortisol', 'Total pethidine requirements, plasma cortisol, PONV, and patients satisfaction']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",75.0,0.0429417,"Results
PO time for 1 st rescue analgesic was significantly high in GI and GII compared to GIII and in GII compared to GI.","[{'ForeName': 'Dina Y', 'Initials': 'DY', 'LastName': 'Kassim', 'Affiliation': 'Department of Anesthesia and Intensive Care, Beni Sweif University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim M', 'Initials': 'IM', 'LastName': 'Esmat', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ain-Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Elgendy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ain-Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_519_17']
1722,31151675,"Re: Continuous Low-dose Antibiotic Prophylaxis for Adults with Repeated Urinary Tract Infections (AnTIC): A Randomized, Open-label Trial.",,2019,,['Adults with Repeated Urinary Tract Infections (AnTIC'],['Re: Continuous Low-dose Antibiotic Prophylaxis'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]",[],,0.0384076,,"[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland. Electronic address: tkessler@gmx.ch.'}]",European urology,['10.1016/j.eururo.2019.05.018']
1723,29373284,Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: The ERECT Trial.,"Erythropoietin receptors have been localized to human penile tissue and periprostatic neurovascular bundles. ERECT is a placebo-controlled, phase 2, randomized trial assessing the effect of erythropoietin on recovery of erectile function for men undergoing radical prostatectomy for prostate cancer.",2019,"ERECT is a placebo-controlled, phase 2, randomized trial assessing the effect of erythropoietin on recovery of erectile function for men undergoing radical prostatectomy for prostate cancer.","['Men Following Radical Prostatectomy', 'men undergoing radical prostatectomy for prostate cancer']","['Erythropoietin', 'erythropoietin']",['Erectile Function'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}]",,0.034009,"ERECT is a placebo-controlled, phase 2, randomized trial assessing the effect of erythropoietin on recovery of erectile function for men undergoing radical prostatectomy for prostate cancer.","[{'ForeName': 'Hiten D', 'Initials': 'HD', 'LastName': 'Patel', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: hitenpatel@jhmi.edu.'}, {'ForeName': 'Mohamad E', 'Initials': 'ME', 'LastName': 'Allaf', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",European urology focus,['10.1016/j.euf.2018.01.002']
1724,31624048,"Cerebellar repetitive transcranial magnetic stimulation (rTMS) for essential tremor: A double-blind, sham-controlled, crossover, add-on clinical trial.","BACKGROUND
There is controversial evidence about the effect of cerebellar low-frequency stimulation in patients with essential tremor (ET).
OBJECTIVES
In this study we assessed safety and effectiveness of 1 Hz (low-frequency) cerebellar repetitive transcranial magnetic stimulation (rTMS) on tremor severity in patients with essential tremor in a sham-controlled crossover trial.
METHODS
A total of 23 patients assigned into two groups to receive either sham (n = 10) or rTMS (n = 13) treatment, with crossing over after a two-month washout period. Intervention consisted of 900 pulses of 1 Hz rTMS at 90% resting motor threshold or the same protocol of sham stimulation over each cerebellar hemisphere for 5 consecutive days. Tremor severity was assessed by Fahn-Tolosa-Marin (FTM) scale at baseline and at days 5, 12 and 30 after intervention. The FTM consists of 3 subscales including tremor severity rating, performance of motor tasks, and functional disability. Carry-over and treatment effects were analyzed using independent samples t-test.
RESULTS
There was no significant improvement in the total FTM scores in rTMS compared to the sham stimulation on day 5 (p = 0.132), day 12 (p = 0.574), or day 30 (p = 0.382). Similarly, FTM subscales, including tremor severity rating, motor tasks, and functional disability did not improve significantly after rTMS treatment. Mild headache and local pain were the most frequent adverse events.
CONCLUSION
Although cerebellar rTMS seems to have acceptable safety when used in ET patients, this study could not prove any efficacy for it in reduction of tremor in these patients. Larger studies are needed to evaluate efficacy of this therapeutic intervention and to provide evidence about the optimal stimulation parameters.",2020,"Similarly, FTM subscales, including tremor severity rating, motor tasks, and functional disability did not improve significantly after rTMS treatment.","['23 patients', 'patients with essential tremor in a sham-controlled crossover trial', 'patients with essential tremor (ET']","['1\u202fHz (low-frequency) cerebellar repetitive transcranial magnetic stimulation (rTMS', '900 pulses of 1\u202fHz rTMS at 90% resting motor threshold or the same protocol of sham stimulation', 'rTMS', 'Cerebellar repetitive transcranial magnetic stimulation (rTMS']","['safety and effectiveness', 'Tremor severity', 'tremor severity rating, performance of motor tasks, and functional disability', 'Mild headache and local pain', 'total FTM scores', 'FTM subscales, including tremor severity rating, motor tasks, and functional disability', 'Fahn-Tolosa-Marin (FTM) scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270736', 'cui_str': 'Benign Essential Tremor'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0222045'}]",900.0,0.152739,"Similarly, FTM subscales, including tremor severity rating, motor tasks, and functional disability did not improve significantly after rTMS treatment.","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Olfati', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Quaem Medical Center, Mashhad, Iran. Electronic address: nahidolfati@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shoeibi', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Quaem Medical Center, Mashhad, Iran. Electronic address: shoeibia@mums.ac.ir.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Abdollahian', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Mashhad University of Medical Sciences, Psychiatry and Behavioral Sciences Research Center, Ibn-Sina Medical Center, Mashhad, Iran. Electronic address: abdollahiane@mums.ac.ir.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Quaem Medical Center, Mashhad, Iran. Electronic address: ahmadih941@mums.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hoseini', 'Affiliation': 'Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: hoseiniar931@mums.ac.ir.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Akhlaghi', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Mashhad University of Medical Sciences, Psychiatry and Behavioral Sciences Research Center, Ibn-Sina Medical Center, Mashhad, Iran. Electronic address: akhlaghis1@mums.ac.ir.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Vakili', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: VakiliV@mums.ac.ir.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Foroughipour', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Quaem Medical Center, Mashhad, Iran. Electronic address: foroughipourm@mums.ac.ir.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Rezaeitalab', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Quaem Medical Center, Mashhad, Iran. Electronic address: rezaeitalabF@mums.ac.ir.'}, {'ForeName': 'Mohammad-Taghi', 'Initials': 'MT', 'LastName': 'Farzadfard', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Quaem Medical Center, Mashhad, Iran. Electronic address: FarzadfardMT@mums.ac.ir.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Layegh', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Mashhad University of Medical Sciences, Quaem Medical Center, Mashhad, Iran. Electronic address: LayeghPr@mums.ac.ir.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Naseri', 'Affiliation': 'Department of Medical Physics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Brain stimulation,['10.1016/j.brs.2019.10.003']
1725,31615336,Investigating the Comparative Suitability of Traditional and Task-Specific Think Aloud Training.,"The think aloud (TA) protocol is used to capture conscious cognition for wide ranging applications. However, the methods used to train the TA technique have been inconsistent, involving a mixture of both traditional guidelines and task-specific examples. This study aimed to examine how best to train the TA process. We recruited 20 competitive golfers as research participants, and we randomly assigned them to equal sized groups of traditional TA training as described by Ericsson and Simon and task-specific training in which participants were familiarized with TA via task-specific examples. Following training, all participants performed a golf task and were asked to TA. We transcribed audiotapes of their verbatim TA content and analyzed them using a deductive framework. We also collected various social validation self-report measures to assess participant perceptions of TA training. Overall, we found no significant differences in the frequency or type of TA verbalizations when comparing traditional and task-specific TA training groups. However, participants in the task-specific training group reported more favorable perceptions of training and found training significantly clearer than did participants in the traditional training group. We suggest that these findings support traditional TA training following Ericsson and Simon's training guidelines, but adding task-specific examples seems to increase the familiarity of TA use and facilitate more reliable and accurate cognition data for research use.",2020,"Overall, we found no significant differences in the frequency or type of TA verbalizations when comparing traditional and task-specific TA training groups.",[],"['traditional TA training as described by Ericsson and Simon and task-specific training in which participants were familiarized with TA via task-specific examples', 'Traditional and Task-Specific Think Aloud Training']","['frequency or type of TA verbalizations', 'favorable perceptions of training']",[],"[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0443058', 'cui_str': 'Simon (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",20.0,0.0179336,"Overall, we found no significant differences in the frequency or type of TA verbalizations when comparing traditional and task-specific TA training groups.","[{'ForeName': 'Phil D J', 'Initials': 'PDJ', 'LastName': 'Birch', 'Affiliation': 'Institute of Sport, University of Chichester, UK.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Whitehead', 'Affiliation': 'School of Sport and Exercise Sciences, Liverpool John Moores University, UK.'}]",Perceptual and motor skills,['10.1177/0031512519882274']
1726,30950165,"""It gave me so much confidence"": First-time U.S. mothers' experiences with antenatal milk expression.","Antenatal milk expression (AME) involves maternal hand-expression, collection, and storage of breast milk during pregnancy for the purposes of reducing the early formula use in breastfed infants. AME is not widely practiced in the United States, despite its growing popularity elsewhere. In this study, we examined the experiences of first-time mothers recruited from a U.S. midwife practice who engaged in AME within the context of a pilot randomized controlled trial. The AME intervention involved demonstration and practice of AME with a lactation consultant beginning at 37 weeks of gestation, reinforcement at weekly study visits until delivery, and daily home practice. Nineteen women participated in a semistructured interview at 1-2 weeks postpartum regarding their study experiences. Major themes included (1) perceived benefits and impact of AME, (b) AME implementation, and (c) use of AME milk. Women perceived multiple benefits of AME, most notably that it increased their confidence that they would be able to make milk and breastfeed successfully postpartum. Women expressed some concern that no/little milk expressed could be indicative of postpartum milk production problems. Regarding implementation, women found that the AME protocol fit well into their daily routine. There was mixed feedback regarding comfort with practicing AME in the presence of partners. Reasons for postpartum use of AME milk varied; barriers to provision included inadequate milk storage options at the birth hospital and unsupportive hospital providers/staff. With few caveats, AME appears to be an acceptable breastfeeding support intervention among a sociodemographically homogeneous group of first-time mothers in the United States.",2019,"With few caveats, AME appears to be an acceptable breastfeeding support intervention among a sociodemographically homogeneous group of first-time mothers in the United States.","['experiences of first-time mothers recruited from a U.S. midwife practice who engaged in AME within the context', 'breastfed infants', 'Nineteen women participated in a semistructured interview at 1-2\xa0weeks postpartum regarding their study experiences']",['AME'],"['Antenatal milk expression (AME) involves maternal hand-expression, collection, and storage of breast milk', 'benefits and impact of AME, (b) AME implementation, and (c) use of AME milk']","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",19.0,0.0380452,"With few caveats, AME appears to be an acceptable breastfeeding support intervention among a sociodemographically homogeneous group of first-time mothers in the United States.","[{'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Demirci', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Glasser', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fichner', 'Affiliation': ""Orthopedic, Neurosurgery, Neurology, and Trauma Unit, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Caplan', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Himes', 'Affiliation': 'Department of OBGYN and Reproductive Sciences, Division of Maternal-Fetal Medicine, University of Pittsburgh School of Medicine, UPMC Magee-Womens Hospital, Pittsburgh, Pennsylvania.'}]",Maternal & child nutrition,['10.1111/mcn.12824']
1727,31607204,A prospective open-label trial of long-acting liquid methylphenidate for the treatment of attention deficit/hyperactivity disorder in intellectually capable adults with autism spectrum disorder.,"Objectives: This treatment trial is aimed at assessing the short-term tolerability and efficacy of liquid-formulation extended-release methylphenidate (MPH-ER) for the treatment of attention deficit/hyperactivity disorder (ADHD) in adults with high-functioning autism spectrum disorder (HF-ASD). Methods: A 6-week open-label trial (ClinicalTrials.gov: NCT02096952) was conducted in 15 HF-ASD adults (mean age 24.9 ± 4.6; male, 12 (80%)) suffering from moderate-severe ADHD. MPH-ER was administered based on a flexible titration schedule. Efficacy was assessed on clinician- and self-rated measures. Tolerability was assessed by documenting treatment-emergent adverse events (AEs) and other safety measures. Results: Short-term MPH-ER treatment was associated with significant improvement in ADHD severity (Adult ADHD Investigator Symptom Report Scale (AISRS) mean change (MC), -22.8 ± 8.8, P < 0.001; Adult ADHD Self-Report Scale (ASRS) MC, -8.2 ± 15.3, P < 0.001). Twelve (80%) participants were deemed responders, based on ≥30% reduction in AISRS score and an ADHD Clinical Global Impression-Improvement score ≤2. MPH-ER was well-tolerated (treatment-limiting AEs, 1/15; severe AEs, 1/15) at mean dose of 48.7 ± 15 mg/day. AEs were transient and experienced by 13/15 (87%) participants at mild to moderate severity. Frequently reported AEs were as typically expected (headache (53%), insomnia (33%), anxiety (33%), decreased appetite (27%)). Conclusions: Our findings suggest that MPH-ER is effective and well-tolerated in the treatment of ADHD in HF-ASD adults.",2020,"mean change [MC]: -22.8 ± 8.8, p < 0.001; Adult ADHD Self-Report Scale [ASRS]","['15 HF-ASD adults (mean age: 24.9\u2009±\u20094.6; male: 12 [80%]) suffering from moderate-severe ADHD', 'Intellectually Capable Adults with Autism Spectrum Disorder', 'adults with high-functioning autism spectrum disorder (HF-ASD']","['Long-Acting Liquid Methylphenidate', 'liquid-formulation extended-release methylphenidate (MPH-ER', 'MC']","['ADHD severity (Adult ADHD Investigator Symptom Report Scale [AISRS', 'AISRS score and an ADHD Clinical Global Impression-Improvement score ≤2', 'Tolerability', 'Efficacy', 'Adult ADHD Self-Report Scale [ASRS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0048853', 'cui_str': 'MPH'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",,0.0642569,"mean change [MC]: -22.8 ± 8.8, p < 0.001; Adult ADHD Self-Report Scale [ASRS]","[{'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Joshi', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'DiSalvo', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wozniak', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'T Atilla', 'Initials': 'TA', 'LastName': 'Ceranoglu', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Yule', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Surman', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ronna', 'Initials': 'R', 'LastName': 'Fried', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Galdo', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Hoskova', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Belser', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': 'Alan and Lorraine Bressler Clinical and Research Program for Autism Spectrum Disorder, Massachusetts General Hospital, Boston, MA, USA.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2019.1679392']
1728,31609865,Dose Escalation of Naltrexone to Reduce Stress Responses Associated With Opioid Antagonist Induction: A Double-blind Randomized Trial.,"CONTEXT
To describe the role of opioid antagonist induction in reducing stress response and withdrawal symptoms.
OBJECTIVE
Complexity of naltrexone induction is limiting broader applicability of opioid antagonist-assisted abstinence. The aim of this clinical trial was to assess the stress response to 2 low-dose naltrexone induction protocols under minimal oral sedation.
DESIGN
Double-blind randomized controlled trial.
SETTING
Open setting in-patient unit.
PARTICIPANTS
Adults with opioid use disorder, and at least a year-long history of opioid use.
INTERVENTION PROTOCOL
Patients received either a single 12.5 mg naltrexone oral dose (SI group) or escalating dosage regimen starting from 50 μg up to a cumulative dose of 12.5 mg (ED group).
MAIN OUTCOME MEASURE
Differences in cortisol and adrenocorticotropic hormone (ACTH) concentrations 1 hour after the start of naltrexone induction.
RESULTS
In all, 124 patients were enrolled and 68 remained in the trial at the point of randomization-33 in SI and 35 in ED group. Eight patients were excluded from final analysis. Plasma cortisol and ACTH concentrations were significantly higher in SI group; mean difference between groups 313 nmol/L (95% confidence interval [CI] 182-444, P < 0.001) and 36.9 pg/mL (95% CI 12.3-61.4, P = 0.004), respectively.
SECONDARY OUTCOMES
SI patients experienced significant increases in plasma cortisol and ACTH concentrations, and withdrawal scores. In ED group these measures remained at or below baseline throughout the 24-hour period from start of naltrexone induction.
CONCLUSIONS
Contrary to a single 12.5-mg dose, the escalating naltrexone dosing regimen produced no significant increase in stress response and withdrawal scores during antagonist induction.",2020,"Plasma cortisol and ACTH concentrations were significantly higher in SI group; mean difference between groups 313 nmol/L (95% confidence interval [CI] 182-444, P < 0.001) and 36.9 pg/mL (95% CI 12.3-61.4, P = 0.004), respectively.
","['124 patients were enrolled and 68 remained in the trial at the point of randomization-33 in SI and 35 in ED group', 'Adults with opioid use disorder, and at least a year-long history of opioid use', 'Eight patients were excluded from final analysis', 'Open setting in-patient unit']","['Naltrexone', 'naltrexone oral dose (SI group) or escalating dosage regimen starting from 50\u200aμg up to a cumulative dose of 12.5\u200amg (ED group', 'naltrexone', 'naltrexone induction protocols', 'Opioid Antagonist Induction']","['stress response and withdrawal scores', 'plasma cortisol and ACTH concentrations, and withdrawal scores', 'stress response', 'Plasma cortisol and ACTH concentrations', 'cortisol and adrenocorticotropic hormone (ACTH) concentrations']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",124.0,0.19885,"Plasma cortisol and ACTH concentrations were significantly higher in SI group; mean difference between groups 313 nmol/L (95% confidence interval [CI] 182-444, P < 0.001) and 36.9 pg/mL (95% CI 12.3-61.4, P = 0.004), respectively.
","[{'ForeName': 'Robertas', 'Initials': 'R', 'LastName': 'Badaras', 'Affiliation': 'Faculty of Medicine, Vilnius University, Lithuania (RB, JI); Clinic of Anesthesiology, Lithuanian University of Health Sciences, Lithuania (TJ); Centre of Toxicology, Vilnius University Emergency Hospital, Lithuania (RB, IL); Department of Critical Care, BHR University Hospitals NHS Trust, UK (TJ).'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jovaisa', 'Affiliation': ''}, {'ForeName': 'Indre', 'Initials': 'I', 'LastName': 'Lapinskiene', 'Affiliation': ''}, {'ForeName': 'Juozas', 'Initials': 'J', 'LastName': 'Ivaskevicius', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000560']
1729,31851348,Effect of a Computer-Based Decision Support Intervention on Autism Spectrum Disorder Screening in Pediatric Primary Care Clinics: A Cluster Randomized Clinical Trial.,"Importance
Universal early screening for autism spectrum disorder (ASD) is recommended but not routinely performed.
Objective
To determine whether computer-automated screening and clinical decision support can improve ASD screening rates in pediatric primary care practices.
Design, Setting, and Participants
This cluster randomized clinical trial, conducted between November 16, 2010, and November 21, 2012, compared ASD screening rates among a random sample of 274 children aged 18 to 24 months in urban pediatric clinics of an inner-city county hospital system with or without an ASD screening module built into an existing decision support software system. Statistical analyses were conducted from February 6, 2017, to June 1, 2018.
Interventions
Four clinics were matched in pairs based on patient volume and race/ethnicity, then randomized within pairs. Decision support with the Child Health Improvement Through Computer Automation system (CHICA) was integrated with workflow and with the electronic health record in intervention clinics.
Main Outcomes and Measures
The main outcome was screening rates among children aged 18 to 24 months. Because the intervention was discontinued among children aged 18 months at the request of the participating clinics, only results for those aged 24 months were collected and analyzed. Rates of positive screening results, clinicians' response rates to screening results in the computer system, and new cases of ASD identified were also measured. Main results were controlled for race/ethnicity and intracluster correlation.
Results
Two clinics were randomized to receive the intervention, and 2 served as controls. Records from 274 children (101 girls, 162 boys, and 11 missing information on sex; age range, 23-30 months) were reviewed (138 in the intervention clinics and 136 in the control clinics). Of 263 children, 242 (92.0%) were enrolled in Medicaid, 138 (52.5%) were African American, and 96 (36.5%) were Hispanic. Screening rates in the intervention clinics increased from 0% (95% CI, 0%-5.5%) at baseline to 68.4% (13 of 19) (95% CI, 43.4%-87.4%) in 6 months and to 100% (18 of 18) (95% CI, 81.5%-100%) in 24 months. Control clinics had no significant increase in screening rates (baseline, 7 of 64 children [10.9%]; 6-24 months after the intervention, 11 of 72 children [15.3%]; P = .46). Screening results were positive for 265 of 980 children (27.0%) screened by CHICA during the study period. Among the 265 patients with positive screening results, physicians indicated any response in CHICA in 151 (57.0%). Two children in the intervention group received a new diagnosis of ASD within the time frame of the study.
Conclusions and Relevance
The findings suggest that computer automation, when integrated with clinical workflow and the electronic health record, increases screening of children for ASD, but follow-up by physicians is still flawed. Automation of the subsequent workup is still needed.
Trial Registration
ClinicalTrials.gov identifier: NCT01612897.",2019,"Screening rates in the intervention clinics increased from 0% (95% CI, 0%-5.5%) at baseline to 68.4% (13 of 19) (95% CI, 43.4%-87.4%) in 6 months and to 100% (18 of 18) (95% CI, 81.5%-100%) in 24 months.","['November 16, 2010, and November 21, 2012, compared ASD screening rates among a random sample of 274 children aged 18 to 24 months in urban pediatric clinics of an inner-city county hospital system with or without an ASD screening module built into an existing decision support software system', 'Autism', 'Of 263 children, 242 (92.0%) were enrolled in Medicaid, 138 (52.5%) were African American, and 96 (36.5%) were Hispanic', '265 patients with positive screening', '274 children (101 girls, 162 boys, and 11 missing information on sex; age range, 23-30 months) were reviewed (138 in the intervention clinics and 136 in the control clinics', 'Pediatric Primary Care Clinics', 'pediatric primary care practices', 'autism spectrum disorder (ASD', '980 children (27.0%) screened by CHICA during the study period']","['computer-automated screening and clinical decision support', 'Computer-Based Decision Support Intervention', 'Computer Automation system (CHICA']","['Screening rates', 'ASD screening rates', 'screening rates', 'response in CHICA']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0020005', 'cui_str': 'Hospitals, County'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0004376', 'cui_str': 'Automation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}]",980.0,0.0813254,"Screening rates in the intervention clinics increased from 0% (95% CI, 0%-5.5%) at baseline to 68.4% (13 of 19) (95% CI, 43.4%-87.4%) in 6 months and to 100% (18 of 18) (95% CI, 81.5%-100%) in 24 months.","[{'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Downs', 'Affiliation': ""Division of Children's Health Services Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis.""}, {'ForeName': 'Nerissa S', 'Initials': 'NS', 'LastName': 'Bauer', 'Affiliation': 'Axon Health Associates LLC, Indianapolis, Indiana.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Saha', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ofner', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Carroll', 'Affiliation': 'Regenstrief Institute Inc, Indianapolis, Indiana.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.17676']
1730,31607604,Immunogenicity of four doses of oral poliovirus vaccine when co-administered with the human neonatal rotavirus vaccine (RV3-BB).,"BACKGROUND
The RV3-BB human neonatal rotavirus vaccine was developed to provide protection from severe rotavirus disease from birth. The aim of this study was to investigate the potential for mutual interference in the immunogenicity of oral polio vaccine (OPV) and RV3-BB.
METHODS
A randomized, placebo-controlled trial involving 1649 participants was conducted from January 2013 to July 2016 in Central Java and Yogyakarta, Indonesia. Participants received three doses of oral RV3-BB, with the first dose given at 0-5 days (neonatal schedule) or ~8 weeks (infant schedule), or placebo. Two sub-studies assessed the immunogenicity of RV3-BB when co-administered with either trivalent OPV (OPV group, n = 282) or inactivated polio vaccine (IPV group, n = 333). Serum samples were tested for antibodies to poliovirus strains 1, 2 and 3 by neutralization assays following doses 1 and 4 of OPV.
RESULTS
Sero-protective rates to poliovirus type 1, 2 or 3 were similar (range 0.96-1.00) after four doses of OPV co-administered with RV3-BB compared with placebo. Serum IgA responses to RV3-BB were similar when co-administered with either OPV or IPV (difference in proportions OPV vs IPV: sIgA responses; neonatal schedule 0.01, 95% CI -0.12 to 0.14; p = 0.847; infant schedule -0.10, 95% CI -0.21 to -0.001; p = 0.046: sIgA GMT ratio: neonatal schedule 1.23, 95% CI 0.71-2.14, p = 0.463 or infant schedule 1.20, 95% CI 0.74-1.96, p = 0.448).
CONCLUSIONS
The co-administration of OPV with RV3-BB rotavirus vaccine in a birth dose strategy did not reduce the immunogenicity of either vaccine. These findings support the use of a neonatal RV3-BB vaccine where either OPV or IPV is used in the routine vaccination schedule.",2019,"Serum samples were tested for antibodies to poliovirus strains 1, 2 and 3 by neutralization assays following doses 1 and 4 of OPV.
","['1649 participants was conducted from January 2013 to July 2016 in Central Java and Yogyakarta, Indonesia']","['RV3-BB rotavirus vaccine', 'oral poliovirus vaccine', 'oral polio vaccine (OPV) and RV3-BB', 'oral RV3-BB', 'placebo', 'OPV or IPV ', 'trivalent OPV (OPV group, n\u202f=\u202f282) or inactivated polio vaccine (IPV']","['Immunogenicity', 'Serum IgA responses to RV3-BB', 'immunogenicity of RV3-BB']","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205803', 'cui_str': 'Java'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}]","[{'cui': 'C0674210', 'cui_str': 'R(t)V3'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0674210', 'cui_str': 'R(t)V3'}]",1649.0,0.341991,"Serum samples were tested for antibodies to poliovirus strains 1, 2 and 3 by neutralization assays following doses 1 and 4 of OPV.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cowley', 'Affiliation': ""Enteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.""}, {'ForeName': 'Rini Mulia', 'Initials': 'RM', 'LastName': 'Sari', 'Affiliation': 'Bio Farma PT, Bandung, Indonesia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Handley', 'Affiliation': ""Enteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Medicines Development for Global Health, Melbourne, Victoria, Australia.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Watts', 'Affiliation': ""Enteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Novilia S', 'Initials': 'NS', 'LastName': 'Bachtiar', 'Affiliation': 'Bio Farma PT, Bandung, Indonesia.'}, {'ForeName': 'Jarir', 'Initials': 'J', 'LastName': 'At Thobari', 'Affiliation': 'Departments of Pharmacology and Therapy, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia; Paediatric Research Office, Department of Paediatrics Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Cahya Dewi', 'Initials': 'CD', 'LastName': 'Satria', 'Affiliation': 'Paediatric Research Office, Department of Paediatrics Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Bogdanovic-Sakran', 'Affiliation': ""Enteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Hera', 'Initials': 'H', 'LastName': 'Nirwati', 'Affiliation': 'Departments of Microbiology, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Clinical Epidemiology and Biostatistics Unit and the Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Clinical Epidemiology and Biostatistics Unit and the Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Kirkwood', 'Affiliation': ""Enteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Bill and Melinda Gates Foundation, Seattle, WA, USA.""}, {'ForeName': 'Yati', 'Initials': 'Y', 'LastName': 'Soenarto', 'Affiliation': 'Paediatric Research Office, Department of Paediatrics Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Bines', 'Affiliation': ""Enteric Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Department of Gastroenterology and Clinical Nutrition, Royal Children's Hospital, Parkville, Victoria, Australia. Electronic address: jebines@unimelb.edu.au.""}]",Vaccine,['10.1016/j.vaccine.2019.09.071']
1731,31492651,"Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial.","BACKGROUND
Ozanimod, a sphingosine 1-phosphate receptor modulator, selectively binds to receptor subtypes 1 and 5 with high affinity. The RADIANCE phase 2 study showed that ozanimod had better efficacy than placebo on MRI measures, with a favourable safety profile, in participants with relapsing multiple sclerosis. The SUNBEAM study aimed to assess the safety and efficacy of ozanimod versus intramuscular interferon beta-1a in participants with relapsing multiple sclerosis.
METHODS
SUNBEAM was a randomised, double-blind, double-dummy, active-controlled phase 3 trial done at 152 academic medical centres and clinical practices in 20 countries. We enrolled participants aged 18-55 years with relapsing multiple sclerosis, baseline expanded disability status scale (EDSS) score of 0·0-5·0, and either at least one relapse within the 12 months before screening or at least one relapse within 24 months plus at least one gadolinium-enhancing lesion within 12 months before screening. Participants were randomly assigned 1:1:1 by a blocked algorithm stratified by country and baseline EDSS score to at least 12 months treatment of either once-daily oral ozanimod 1·0 mg or 0·5 mg or weekly intramuscular interferon beta-1a 30 μg. Participants, investigators, and study staff were masked to treatment assignment. The primary endpoint was annualised relapse rate (ARR) during the treatment period and was assessed in the intention-to-treat population. Safety was assessed in all participants according to the highest dose of ozanimod received. This trial is registered at ClinicalTrials.gov, number NCT02294058 and EudraCT, number 2014-002320-27.
FINDINGS
Between Dec 18, 2014, and Nov 12, 2015, 1346 participants were enrolled and randomly assigned to ozanimod 1·0 mg (n=447), ozanimod 0·5 mg (n=451), or interferon beta-1a (n=448). 91 (6·8%) participants discontinued the study drug (29 in the ozanimod 1·0 mg group; 26 in the ozanimod 0·5 mg group; and 36 in the interferon beta-1a group). Adjusted ARRs were 0·35 (0·28-0·44) for interferon beta-1a, 0·18 (95% CI 0·14-0·24) for ozanimod 1·0 mg (rate ratio [RR] of 0·52 [0·41-0·66] vs interferon beta-1a; p<0·0001), and 0·24 (0·19-0·31) for ozanimod 0·5 mg (RR 0·69 [0·55-0·86] vs interferon beta-1a; p=0·0013). Few ozanimod-treated participants discontinued treatment because of adverse events (13 [2·9%] who received ozanimod 1·0 mg; seven [1·5%] who received ozanimod 0·5 mg; and 16 [3·6%] who received interferon beta-1a). No first-dose, clinically significant bradycardia or second-degree or third-degree atrioventricular block was reported. The incidence of serious adverse events was low and similar across treatment groups (13 [2·9%] participants who received ozanimod 1·0 mg; 16 [3·5%] who received ozanimod 0·5 mg; and 11 [2·5%] who received interferon beta-1a). No serious opportunistic infections occurred in ozanimod-treated participants.
INTERPRETATION
In participants with relapsing multiple sclerosis treated for at least 12 months, ozanimod was well tolerated and demonstrated a significantly lower relapse rate than interferon beta-1a. These findings provide support for ozanimod as an oral therapy for individuals with relapsing multiple sclerosis.
FUNDING
Celgene International II.",2019,Adjusted ARRs were 0·35,"['number 2014-002320-27', '0·41-0·66', 'individuals with relapsing multiple sclerosis', 'relapsing multiple sclerosis (SUNBEAM', 'Between Dec 18, 2014, and Nov 12, 2015, 1346 participants', 'enrolled participants aged 18-55 years with relapsing multiple sclerosis, baseline expanded disability status scale (EDSS) score of 0·0-5·0, and either at least one relapse within the 12 months before screening or at least one relapse within 24 months plus at least one gadolinium-enhancing lesion within 12 months before screening', '152 academic medical centres and clinical practices in 20 countries', 'participants with relapsing multiple sclerosis']","['ozanimod 0·5 mg (n=451), or interferon beta-1a', 'ozanimod 0·5 mg (RR 0·69', 'placebo', 'ozanimod', 'ozanimod 1·0 mg or 0·5 mg or weekly intramuscular interferon beta-1a 30 μg']","['MRI measures', 'adverse events', 'Safety', 'serious opportunistic infections', 'Safety and efficacy', 'annualised relapse rate (ARR', 'bradycardia or second-degree or third-degree atrioventricular block', 'relapse rate', 'incidence of serious adverse events', 'safety and efficacy']","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",1346.0,0.300239,Adjusted ARRs were 0·35,"[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy. Electronic address: comi.giancarlo@hsr.it.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, University Hospital and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Krzysztof W', 'Initials': 'KW', 'LastName': 'Selmaj', 'Affiliation': 'Center for Neurology, Lodz, Poland; Collegium Medicum, Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'Center for Neuroinflammation and Experimental Therapeutics, and Multiple Sclerosis Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'NeuroRx Research and Montreal Neurological Institute, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Steinman', 'Affiliation': 'Department of Neurology and Neurological Sciences, Beckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine University, Dusseldorf, Germany.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Division of Neurology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada; Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kubala Havrdová', 'Affiliation': 'Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Sheffield', 'Affiliation': 'Department of Clinical Development, Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Minton', 'Affiliation': 'Drug Safety, Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Raghupathi', 'Affiliation': 'Department of Biostatistics, Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ding', 'Affiliation': 'Department of Biostatistics, Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cohen', 'Affiliation': 'Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30239-X']
1732,31609637,"FOLFOXIRI Plus Panitumumab As First-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer: The Randomized, Open-Label, Phase II VOLFI Study (AIO KRK0109).","PURPOSE
This trial investigated the addition of panitumumab to triplet chemotherapy with fluorouracil/folinic acid, oxaliplatin, and irinotecan (FOLFOXIRI) in a two-to-one randomized, controlled, open-label, phase II trial in patients with untreated RAS wild-type (WT) metastatic colorectal cancer.
PATIENTS AND METHODS
The primary end point was objective response rate (ORR) according to RECIST (version 1.1). The experimental arm (modified FOLFOXIRI [mFOLFOXIRI] plus panitumumab) was considered active if the ORR was ≥ 75%. The experimental ORR was compared with an estimated ORR of 60% based on historical data, verified by a randomized control group (FOLFOXIRI). The power of the trial was 80%, with a potential type I error of 0.05. Secondary end points included secondary resection rate, toxicity, progression-free survival, and overall survival.
RESULTS
A total of 63 patients were randomly assigned to the experimental arm and 33 patients to the control arm. The ORR of the mFOLFOXIRI plus panitumumab arm exceeded 75% and was higher when compared with that of FOLFOXIRI (87.3% v 60.6%; odds ratio, 4.469; 95% CI, 1.61 to 12.38; P = .004). The secondary resection rate was improved with the addition of panitumumab (33.3% v 12.1%; P = .02). Progression-free survival was similar in the study arms, whereas overall survival showed a trend in favor of the panitumumab-containing arm (hazard ratio for death, 0.67; 95% CI, 0.41 to 1.11; P = .12).
CONCLUSION
The addition of panitumumab to mFOLFOXIRI in patients with RAS WT metastatic colorectal cancer improved the ORR and rate of secondary resection of metastases and represents a treatment option in selected and fit patients in need of highly active first-line therapy. Future studies should determine whether the addition of panitumumab to mFOLFOXIRI prolongs survival.",2019,"Progression-free survival was similar in the study arms, whereas overall survival showed a trend in favor of the panitumumab-containing arm (hazard ratio for death, 0.67; 95% CI, 0.41 to 1.11; P = .12).
","['Wild-Type Metastatic Colorectal Cancer', '63 patients', 'patients with untreated RAS wild-type (WT) metastatic colorectal cancer', 'patients with RAS WT metastatic colorectal cancer']","['panitumumab to triplet chemotherapy with fluorouracil/folinic acid, oxaliplatin, and irinotecan (FOLFOXIRI', 'FOLFOXIRI Plus Panitumumab', 'panitumumab', 'experimental arm (modified FOLFOXIRI [mFOLFOXIRI] plus panitumumab']","['Progression-free survival', 'overall survival', 'objective response rate (ORR', 'secondary resection rate', 'secondary resection rate, toxicity, progression-free survival, and overall survival']","[{'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.204724,"Progression-free survival was similar in the study arms, whereas overall survival showed a trend in favor of the panitumumab-containing arm (hazard ratio for death, 0.67; 95% CI, 0.41 to 1.11; P = .12).
","[{'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Uwe M', 'Initials': 'UM', 'LastName': 'Martens', 'Affiliation': 'Klinik für Innere Medizin III, SLK-Kliniken Heilbronn, Heilbronn, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Riera-Knorrenschild', 'Affiliation': 'Universitätsklinik Marburg, Marburg, Germany.'}, {'ForeName': 'Jobst', 'Initials': 'J', 'LastName': 'Greeve', 'Affiliation': 'St Vincenz-Krankenhaus Paderborn, Paderborn, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Florschütz', 'Affiliation': 'Stadtisches Klinikum Dessau, Dessau, Germany.'}, {'ForeName': 'Swen', 'Initials': 'S', 'LastName': 'Wessendorf', 'Affiliation': 'Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ettrich', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kanzler', 'Affiliation': 'Leopoldina Krankenhaus, Schweinfurt, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Nörenberg', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ricke', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Seidensticker', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess, Leverkusen, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Buechner-Steudel', 'Affiliation': 'Universitätsklinikum Halle (Saale), Halle, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Atzpodien', 'Affiliation': 'Franziskus-Hospital Harderberg, Georgsmarienhütte, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tannapfel', 'Affiliation': 'Ruhr Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Anke C', 'Initials': 'AC', 'LastName': 'Reinacher-Schick', 'Affiliation': 'St Josef Hospital, Bochum, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Geissler', 'Affiliation': 'Klinikum Esslingen, Esslingen, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01340']
1733,29205992,Curative effect of knee arthroplasty on patients with osteoarthritis and analysis of long-term joint function of these patients.,"BACKGROUND
The aim of this study was to explore the curative effect of knee arthroplasty on patients with osteoarthritis and analysis of their long-term joint function.
METHODS
Ninety-six cases of osteoarthritis patients, collected in our hospital from June 2010 to May 2011, were divided into control group and observation group (N.=48 in each group). Patients in observation group were treated by knee replacement, and patients in control group were treated by arthroscopic debridement. Bleeding during operation of patients and the operation time in both groups were comparable during their followed up for 6~60 months, with an average of 52 months. Neer score was used to compare the curative effect of patients after 6 months; knee society score (KSS) was used to compare knee joint function and knee joint of motion (ROM) of patients several days prior to surgery and after 6 months, 12 months, 24 months, and 48 months. Visual analogue scale (VAS) was used to compare pain degrees of patients at the last follow-up.
RESULTS
By Neer score comparison, after 6 months excellent and good rate of patients in observation group (91.67%) was obviously higher than that of control group 70.83% (P<0.05); ROM of patients in observation group was obviously higher than that in control group (P<0.05); After six months, KSS score of patients in both groups greatly improved. As well, with the extension of time, their knee joint function showed a better trend, and KSS score of patients in observation group was obviously higher than that of control group (P<0.05). Pain of patients in observation group was significantly lower than that in control group (P<0.05).
CONCLUSIONS
Both arthroscopy debridement and knee replacement have good curative effect. The curative effect of knee replacement was better, postoperative knee joint activity was obviously improved, the long-term recovery of knee joint function was good, and knee replacement can reduce the pain of the patients.",2019,"Bleeding during operation of patients and the operation time in both groups were comparable during their followed up for 6~60 months, with an average of 52 months.","['patients with osteoarthritis and analysis of long-term joint function of these patients', '96 cases of osteoarthritis patients, collected in our hospital from June 2010 to May 2011', 'patients with osteoarthritis and analysis of their long-term joint function']","['knee arthroplasty', 'arthroscopic debridement']","['good rate of pa', 'Bleeding', 'Pain', 'pain degrees', 'knee society score (KSS', 'Visual analogue scale (VAS', 'ROM', 'extension of time, their knee joint function', 'KSS score', 'postoperative knee joint activity', 'knee joint function and knee joint of motion (ROM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}]",,0.0184933,"Bleeding during operation of patients and the operation time in both groups were comparable during their followed up for 6~60 months, with an average of 52 months.","[{'ForeName': 'Xianxun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Third People's Hospital of Hubei Province, Wuhan, Hubei, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Orthopedics, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China - cailin201611@163.com.'}]",Minerva chirurgica,['10.23736/S0026-4733.17.07464-8']
1734,31605208,Balneotherapy for musculoskeletal pain: does the mineral content matter?,"Musculoskeletal pain is a health challenge with various treatment strategies. The study has been accomplished with the aim to reveal the effect of mineral water with different mineral content on musculoskeletal pain and related symptoms experienced. A randomized controlled single-blinded parallel-group study has been performed (145 participants with pain; 5 groups). The duration of treatment was 2 weeks, whereas follow-up has taken 3 months. Change in pain after a single procedure and the pain parameters with related symptoms during the study period have been measured. The effect size using Cohen's d has been estimated. Small effect (0.2-0.4) on pain has been distinguished after each mineral water procedure. Tap water procedures have been effective in 60% of cases. Twenty grams per liter water baths have had a small effect on pain intensity and tender points, body flexibility, and spinal mobility, and a medium one on sleep quality, and reduced CRP. Forty grams per liter water has had a small effect on pain intensity, frequency, and spinal mobility, and a medium one on flexibility, fatigue, and sleep quality, and reduced ESR. Sixty grams per liter water has had a small effect on pain parameters and fatigue, and a medium one on flexibility and sleep quality, and reduced ESR. The effect lasting up to 2 months has been identified mostly in the 60 g/L group. Tap water has had a short time effect on pain intensity and tender points. There have not been any changes of sufficient significance identified in the control group and any differences between mineral water groups. Sufficient difference between mineral and tap water groups has been determined in pain intensity, spinal mobility, and sleep quality, whereas in the case of the control group, significant difference in pain intensity and frequency, flexibility, and spinal mobility has been identified. The consumption of pain medication has significantly decreased in all mineral water groups. The total mineral content of the water has no significant influence on the reduction of musculoskeletal pain. Mineral water baths have small effect on pain and medium effect on other musculoskeletal disease-related symptoms and pain medication consumption lasting up to 3 months; it is more beneficial than tap water or no treatment for the improvement of symptoms associated with musculoskeletal diseases. Even single balneotherapy procedure results in small pain reduction.",2020,"Sufficient difference between mineral and tap water groups has been determined in pain intensity, spinal mobility, and sleep quality, whereas in the case of the control group, significant difference in pain intensity and frequency, flexibility, and spinal mobility has been identified.","['145 participants with pain; 5 groups', 'musculoskeletal pain']",['Balneotherapy'],"['flexibility and sleep quality, and reduced ESR', 'pain intensity, frequency, and spinal mobility, and a medium one on flexibility, fatigue, and sleep quality, and reduced ESR', 'pain intensity, spinal mobility, and sleep quality', 'musculoskeletal pain', 'pain intensity and tender points', 'pain intensity and frequency, flexibility, and spinal mobility', 'small pain reduction', 'pain intensity and tender points, body flexibility, and spinal mobility, and a medium one on sleep quality, and reduced CRP', 'consumption of pain medication', 'Musculoskeletal pain', 'pain parameters and fatigue', 'Change in pain']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}]","[{'cui': 'C0085867', 'cui_str': 'Balneotherapy'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",145.0,0.0655306,"Sufficient difference between mineral and tap water groups has been determined in pain intensity, spinal mobility, and sleep quality, whereas in the case of the control group, significant difference in pain intensity and frequency, flexibility, and spinal mobility has been identified.","[{'ForeName': 'Lolita', 'Initials': 'L', 'LastName': 'Rapolienė', 'Affiliation': 'Klaipėda Seamen Health Care Center, Taikos str. 46, LT-91213, Klaipėda, Lithuania. lolita.rapoliene@inbox.lt.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Razbadauskas', 'Affiliation': 'Klaipėda University, Herkus Mantas str. 84, LT-92294, Klaipėda, Lithuania.'}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Mockevičienė', 'Affiliation': 'Klaipėda University, Herkus Mantas str. 84, LT-92294, Klaipėda, Lithuania.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Varžaitytė', 'Affiliation': 'Lithuanian University of Health Sciences, A. Mickevičiaus g. 9, LT44307, Kaunas, Lithuania.'}, {'ForeName': 'Aelita', 'Initials': 'A', 'LastName': 'Skarbalienė', 'Affiliation': 'Klaipėda University, Herkus Mantas str. 84, LT-92294, Klaipėda, Lithuania.'}]",International journal of biometeorology,['10.1007/s00484-019-01800-3']
1735,29117336,Clinical and genetic predictors of paclitaxel neurotoxicity based on patient- versus clinician-reported incidence and severity of neurotoxicity in the ICON7 trial.,"Background
Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting toxicity of paclitaxel, with no reliable method to identify at-risk patients. We investigated the incidence and risk factors including genetic polymorphisms associated with the development of CIPN based on clinician and patient reporting of neuropathic symptoms.
Patients and methods
Risk factors for the development of CIPN were examined in 454 patients treated with paclitaxel/carboplatin from the International Collaboration on Ovarian Neoplasms 7 (ICON7) trial. Neuropathy was graded by clinicians by standard adverse event reporting and by patients utilising OV28 questionnaire. Genetic risk factors were examined by selecting six single nucleotide polymorphisms in genes associated with microtubule function. Risk factors were assessed via dose-to-event cox regression models.
Results
Grade >2 neuropathy was reported by clinicians in 28% of patients, while 67% of patients reported 'quite a bit' or 'very much' tingling or numbness. Agreement between clinicians and patients was poor (κ = 0.236, 95% confidence interval, 0.177-0.296, P < 0.001). Older age, bevacizumab treatment and bowel resection were associated with clinician reported CIPN, while older age and volume of residual disease were associated with patient-reported neuropathy. There were no significant associations between clinician-reported neuropathy or patient-reported neuropathy and TUBB2, CEP72 or individual MAPT or GSK3B SNPs, however MAPT additive polymorphisms were associated with patient-reported neuropathy and GSK3B additive polymorphisms were associated with clinician reported CIPN.
Conclusions
There was significant discordance between patient- and clinician-reported neurotoxicity. The lack of consensus regarding optimal outcome measures and whose opinion with regard to CIPN takes precedence is a limitation in the investigation of risk factors for CIPN. Care must be taken to select and include patient-reported outcome measures in CIPN assessment to enable accurate identification of genetic and other risk factors for neuropathy.",2017,"There were no significant associations between clinician-reported neuropathy or patient-reported neuropathy and TUBB2, CEP72 or individual MAPT or GSK3B SNPs, however MAPT additive polymorphisms were associated with patient-reported neuropathy and GSK3B additive polymorphisms were associated with clinician reported CIPN.
",['454 patients treated with'],"['paclitaxel/carboplatin', 'bevacizumab', '\n\n\nChemotherapy-induced peripheral neuropathy (CIPN']","[""quite a bit' or 'very much' tingling or numbness"", '2 neuropathy', 'Neuropathy', 'neurotoxicity', 'Risk factors']","[{'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C0045724', 'cui_str': 'BIT alkylating agent'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",454.0,0.0265822,"There were no significant associations between clinician-reported neuropathy or patient-reported neuropathy and TUBB2, CEP72 or individual MAPT or GSK3B SNPs, however MAPT additive polymorphisms were associated with patient-reported neuropathy and GSK3B additive polymorphisms were associated with clinician reported CIPN.
","[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Brain and Mind Centre, Sydney Medical School, University of Sydney, Sydney; Prince of Wales Clinical School.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Kwok', 'Affiliation': 'Brain and Mind Centre, Sydney Medical School, University of Sydney, Sydney; Neuroscience Research Australia, University of New South Wales, Sydney.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beale', 'Affiliation': 'Concord Cancer Centre, Concord Repatriation General Hospital, Sydney; Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Selle', 'Affiliation': ""Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens and Department of Medical Oncology, Alliance For Cancer Research, Hôpital Tenon, Paris, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Prince of Wales Clinical School. Electronic address: m.friedlander@unsw.edu.au.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx491']
1736,29068818,Simulation-Based Mastery Learning for Thoracentesis Skills Improves Patient Outcomes: A Randomized Trial.,"PURPOSE
Physicians-in-training often perform bedside thoracenteses in academic medical centers, and complications are more common among less experienced clinicians. Simulation-based mastery learning (SBML) is one potential solution to this problem. This study evaluated the effects of a randomized trial of thoracentesis SBML on patient complications: iatrogenic pneumothorax (IP), hemothorax, and reexpansion pulmonary edema (REPE).
METHOD
The authors randomized internal medicine residents to undergo thoracentesis SBML at a tertiary care academic center from December 2012 to May 2016. They subsequently compared thoracentesis complications from procedures performed by SBML-trained residents, traditionally trained residents (no simulation training), and those referred to pulmonary medicine or interventional radiology (IR).
RESULTS
During the study period, 917 thoracenteses were performed on 709 patients. IP occurred in 60 (6.5%) procedures, of which 7 (11.6%) were clinically meaningful. SBML-trained residents performed procedures with a trend toward lower combined clinically meaningful complications (IP, hemothorax, REPE) compared with traditionally trained residents (7.9% vs. 0%; P = .06). SBML-trained residents caused fewer clinically meaningful IPs compared with traditionally trained residents, pulmonary, and IR referrals (P = .02). Hemothorax occurred after 4 (0.4%) thoracenteses, and SBML-trained residents had a trend toward lower hemothorax (0) compared with other groups (P = .07). REPE occurred after 3 (0.3%) procedures, with no differences between groups. SBML-trained residents performed procedures with lower combined clinically meaningful complications compared with other groups (P = .008).
CONCLUSIONS
Residents randomized to an SBML intervention performed thoracenteses with low rates of clinically meaningful complications. Rigorous education represents a successful quality improvement strategy.",2018,"SBML-trained residents performed procedures with lower combined clinically meaningful complications compared with other groups (P = .008).
","['917 thoracenteses were performed on 709 patients', 'internal medicine residents to undergo thoracentesis SBML at a tertiary care academic center from December 2012 to May 2016']","['SBML intervention', 'Simulation-Based Mastery Learning for Thoracentesis Skills', 'Simulation-based mastery learning (SBML', 'thoracentesis SBML', 'pulmonary medicine or interventional radiology (IR']","['patient complications: iatrogenic pneumothorax (IP), hemothorax, and reexpansion pulmonary edema (REPE', 'Hemothorax', 'REPE']","[{'cui': 'C0189477', 'cui_str': 'Thoracocentesis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0189477', 'cui_str': 'Thoracocentesis'}, {'cui': 'C0034060', 'cui_str': 'Pneumology'}, {'cui': 'C0034602', 'cui_str': 'Interventional radiology - specialty'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0375336', 'cui_str': 'Iatrogenic pneumothorax'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C1611712', 'cui_str': 'Reexpansion pulmonary oedema'}]",917.0,0.0483445,"SBML-trained residents performed procedures with lower combined clinically meaningful complications compared with other groups (P = .008).
","[{'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Barsuk', 'Affiliation': ""J.H. Barsuk is professor of medicine, Departments of Medicine and Medical Education, Northwestern University Feinberg School of Medicine, Chicago, Illinois. E.R. Cohen is a research associate, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. M.V. Williams is professor of medicine, director, Center for Health Services Research, and vice chair, Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, Kentucky. J. Scher is research coordinator, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. S.F. Jones is research coordinator, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. J. Feinglass is research professor of medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. W.C. McGaghie is professor of medical education, Department of Medical Education, Northwestern University Feinberg School of Medicine, Chicago, Illinois. K. O'Hara is instructor, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. D.B. Wayne is vice dean for education and Dr. John Sherman Appleman Professor of Medicine, Departments of Medicine and Medical Education, Northwestern University Feinberg School of Medicine, Chicago, Illinois.""}, {'ForeName': 'Elaine R', 'Initials': 'ER', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Scher', 'Affiliation': ''}, {'ForeName': 'Sasha F', 'Initials': 'SF', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Feinglass', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'McGaghie', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': ""O'Hara"", 'Affiliation': ''}, {'ForeName': 'Diane B', 'Initials': 'DB', 'LastName': 'Wayne', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000001965']
1737,31599627,Duluth versus cognitive behavioral therapy: A natural field experiment on intimate partner violence diversion programs.,"We used data from a 3-year natural field experiment to study rates of recidivism in 2 types of diversion programs designed to reduce intimate partner violence (IPV) among heterosexual partners. In one program (Duluth), efforts are focused on protecting women from male aggression through a psychoeducational program, regardless of the offender's sex. In the other program (cognitive behavioral therapy [CBT]), efforts are focused on improving intrahousehold behaviors and communication skills through counseling. Our experimental results found that the IPV recidivism rate, measured as reconvictions for IPV, was 11 percentage points higher for offenders randomly assigned to a Duluth treatment program (14 percentage points higher among males). This outcome is statistically and practically significant, suggesting that the Duluth approach corresponds to meaningfully higher recidivism rates compared with CBT. In an attempt to explain the observed difference of IPV recidivism between these programs, we discuss theories for plausible psychological, sociological, psychophysiological, and neurological mechanisms responsible for this outcome. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"This outcome is statistically and practically significant, suggesting that the Duluth approach corresponds to meaningfully higher recidivism rates compared with CBT.","['intimate partner violence diversion programs', 'heterosexual partners']","['program (cognitive behavioral therapy [CBT', 'Duluth versus cognitive behavioral therapy']","['IPV recidivism rate', 'recidivism rates', 'intimate partner violence (IPV']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",2019.0,0.0164288,"This outcome is statistically and practically significant, suggesting that the Duluth approach corresponds to meaningfully higher recidivism rates compared with CBT.","[{'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Cotti', 'Affiliation': 'Department of Economics.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': 'Department of Economics.'}, {'ForeName': 'M Ryan', 'Initials': 'MR', 'LastName': 'Haley', 'Affiliation': 'Department of Economics.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Rawski', 'Affiliation': 'Department of Management and Human Resources.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000249']
1738,31177999,Effects of Mediterranean diet supplemented with lean pork on blood pressure and markers of cardiovascular risk: findings from the MedPork trial.,"The Mediterranean diet offers a range of health benefits. However, previous studies indicate that the restricted consumption of red meat in the diet may affect long-term sustainability in non-Mediterranean countries. A 24-week randomised controlled parallel cross-over design compared a Mediterranean diet supplemented with 2-3 serves per week of fresh, lean pork (MedPork) with a low-fat control diet (LF). Thirty-three participants at risk of CVD followed each intervention for 8 weeks, with an 8-week washout period separating interventions. The primary outcome was home-measured systolic blood pressure. Secondary outcomes included diastolic blood pressure, fasting lipids, glucose, insulin, C-reactive protein (CRP), body composition and dietary adherence. During the MedPork intervention, participants achieved high adherence to dietary guidelines. Compared with the MedPork intervention, the LF intervention led to greater reductions in weight (Δ = -0·65; 95 % CI -0·04, -1·25 kg, P = 0·04), BMI (Δ = -0·25; 95 % CI -0·03, -0·47 kg/m2, P = 0·01) and waist circumference (Δ = -1·40; 95 % CI -0·45, -2·34 cm, P < 0·01). No significant differences were observed for blood pressure, lipids, glucose, insulin or CRP. These findings indicate that Australians are capable of adhering to a Mediterranean diet with 2-3 weekly serves of fresh, lean pork. Larger intervention studies are now required to demonstrate clinical efficacy of the diet in populations with elevated blood pressure.",2019,"Compared with the MedPork intervention, the LF intervention led to greater reductions in weight (Δ = 0·65; 95 % CI: 0·04, 1·25 kg, P = 0·04),",[],"['Mediterranean diet supplemented with 2-3 serves per week of fresh, lean pork (MedPork) with a low-fat control diet (LF', 'Mediterranean diet supplemented with lean pork', 'LF intervention']","['waist circumference', 'BMI', 'blood pressure and markers of cardiovascular risk', 'blood pressure, lipids, glucose, insulin or CRP', 'home-measured systolic blood pressure', 'diastolic blood pressure, fasting lipids, glucose, insulin, C-reactive protein (CRP), body composition and dietary adherence', 'weight']",[],"[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0452867', 'cui_str': 'Pork'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0452286', 'cui_str': 'Fat controlled diet (finding)'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0709223,"Compared with the MedPork intervention, the LF intervention led to greater reductions in weight (Δ = 0·65; 95 % CI: 0·04, 1·25 kg, P = 0·04),","[{'ForeName': 'Alexandra T', 'Initials': 'AT', 'LastName': 'Wade', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Davis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Dyer', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, WA 6000, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, GPO Box 2100 Adelaide, SA 5001, Australia.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Murphy', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia.'}]",The British journal of nutrition,['10.1017/S0007114519001168']
1739,31597624,"Efficacy of early controlled motion of the ankle compared with immobilisation in non-operative treatment of patients with an acute Achilles tendon rupture: an assessor-blinded, randomised controlled trial.","BACKGROUND
Early controlled motion (ECM) of the ankle is widely used in the non-operative treatment of acute Achilles tendon rupture, although its safety and efficacy have not been investigated properly in a randomised set-up.
PURPOSE/AIM OF THE STUDY
To investigate if ECM of the ankle was superior to immobilisation in the treatment of acute Achilles tendon rupture.
MATERIALS AND METHODS
This was an assessor-blinded, randomised controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged 18-70 years were eligible for inclusion. The ECM group performed movements of the ankle five times a day from week 3 to week 8 after rupture. The control group was immobilised for 8 weeks. The primary outcome was the Achilles tendon Total Rupture Score (ATRS) evaluated at 1-year postinjury. The secondary outcomes were heel-rise work test (HRW), Achilles tendon elongation and rate of rerupture. Analysis was conducted as intention-to-treat using inverse probability weighting.
FINDINGS/RESULTS
189 patients were assessed for eligibility and 130 were included from February 2014 to December 2016. There were 64 patients in the ECM group and 58 in the immobilisation group. There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively. HRW was 60% (21) and 60% (21) of the uninjured limb, and elongation was 18 mm (13) and 16 mm (11), respectively. Correspondingly, there were six and seven reruptures.
CONCLUSIONS
ECM revealed no benefit compared with immobilisation in any of the investigated outcomes.
TRIAL REGISTRATION NUMBER
NCT02015364.",2020,"There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively.","['Patients aged 18-70 years were eligible for inclusion', 'acute Achilles tendon rupture', '64 patients in the ECM group and 58 in the immobilisation group', '189 patients were assessed for eligibility and 130 were included from February 2014 to December 2016', 'patients with an acute Achilles tendon rupture']","['ECM', 'immobilisation']","['heel-rise work test (HRW), Achilles tendon elongation and rate of rerupture', 'HRW', 'Achilles tendon Total Rupture Score (ATRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0151937', 'cui_str': 'Traumatic rupture of tendon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0263970', 'cui_str': 'Rupture of Achilles tendon'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",189.0,0.402862,"There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively.","[{'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Department of Orthopeadic Surgery, Copenhagen University Hospital Hvidovre, Sports Orthopeadic Research Center - Copenhagen (SORC-C), Copenhagen, Denmark kbarfod@dadlnet.dk.'}, {'ForeName': 'Maria Swennergren', 'Initials': 'MS', 'LastName': 'Hansen', 'Affiliation': 'Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hölmich', 'Affiliation': 'Department of Orthopeadic Surgery, Copenhagen University Hospital Hvidovre, Sports Orthopeadic Research Center - Copenhagen (SORC-C), Copenhagen, Denmark.'}, {'ForeName': 'Morten Tange', 'Initials': 'MT', 'LastName': 'Kristensen', 'Affiliation': 'Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopaedic Surgery, Clinical Orthopaedic Research Hvidovre, Copenhagen University Hospital, Copenhagen, Denmark.'}]",British journal of sports medicine,['10.1136/bjsports-2019-100709']
1740,31328311,Pressure-guided second-generation cryoballoon pulmonary vein isolation: Prospective comparison of the procedural and clinical outcomes with the conventional strategy.,"BACKGROUND
The utility of pressure waveform analyses to assess pulmonary vein (PV) occlusions has been reported in cryoballoon PV isolation (CB-PVI) using first-generation CBs. This prospective randomized study compared the procedural and clinical outcomes of pressure-guided and conventional CB-PVI.
METHODS AND RESULTS
Sixty patients with paroxysmal atrial fibrillation underwent CB-PVI with 28-mm second-generation CBs. PV occlusions were assessed either by real-time pressure waveforms without contrast utilization (pressure-guided group) or contrast injections (conventional group) and randomly assigned. Before the randomization, 24 patients underwent pressure-guided CB-PVIs. In the derivation study, a vein occlusion was obtained in 88/96 (91.7%) PVs among which 86 (97.7%) were successfully isolated by the application. In the validation study, the nadir balloon temperature and total freezing time did not significantly differ per PV between the two groups. The positive predictive value of the vein occlusion for predicting successful acute isolations was similar (93 of 103 [90.2%] and 89 of 98 [90.8%] PVs; P = 1.000), but the negative predictive value was significantly higher in pressure-guided than angiographical occlusions (14 of 17 [82.3%] vs 7 of 22 [31.8%]; P = .003). Both the procedure (57.7 ± 14.2 vs 62.6 ± 15.8 minutes; P = .526) and fluoroscopic times (16.3 ± 6.4 vs 20.1 ± 6.1; P = .732) were similar between the two groups, however, the fluoroscopy dose (130.6 ± 97.7 vs 353.2 ± 231.4 mGy; P < .001) and contrast volume used (0 vs 17.5 ± 7.7 mL; P < .001) were significantly smaller in the pressure-guided than conventional group. During 27.8 (5-39) months of follow-up, the single procedure arrhythmia freedom was similar between the two groups (P = .438).
CONCLUSIONS
Pressure-guided second-generation CB-PVIs were similarly effective and as safe as conventional CB-PVIs. This technique required no contrast utilization and significantly reduced radiation exposure more than conventional CB-PVIs.",2019,"CONCLUSIONS
Pressure-guided second-generation CB-PVIs were similarly effective and as safe as conventional CB-PVIs.","['24 patients underwent pressure-guided CB-PVIs', 'Sixty patients with paroxysmal atrial fibrillation underwent CB-PVI with 28-mm second-generation CBs']","['real-time pressure waveforms without contrast utilization (pressure-guided group) or contrast injections (conventional group', 'Pressure-guided second-generation cryoballoon pulmonary vein isolation', 'pressure-guided and conventional CB-PVI']","['nadir balloon temperature and total freezing time', 'single procedure arrhythmia freedom', 'fluoroscopic times', 'successful acute isolations', 'vein occlusion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449980', 'cui_str': 'Pressure waveform (attribute)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}]",60.0,0.05328,"CONCLUSIONS
Pressure-guided second-generation CB-PVIs were similarly effective and as safe as conventional CB-PVIs.","[{'ForeName': 'Kanae', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Kaseno', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Hisazaki', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Amaya', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Miyahara', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Aiki', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Moe', 'Initials': 'M', 'LastName': 'Mukai', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Matsui', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Daisetsu', 'Initials': 'D', 'LastName': 'Aoyama', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Shiomi', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Tama', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ikeda', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Yoshitomo', 'Initials': 'Y', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Morishita', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Uzui', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14080']
1741,29033716,"Transdermal fentanyl as an adjuvant to paravertebral block for pain control after breast cancer surgery: A randomized, double-blind controlled trial.","OBJECTIVE
The aim of this study is to investigate the effect of transdermal fentanyl (TDF) as an adjuvant to paravertebral block (PVB) for pain control after breast cancer surgery.
PATIENTS AND METHODS
This randomized, double-blind trial included fifty females with breast cancer scheduled for surgery. They were randomly allocated into one of two equal groups. The TDF group used transdermal fentanyl patches (TFPs) 25 μg/h applied 10 h preoperative then PVB with 20 mL of bupivacaine 0.25% was done before induction of general anesthesia. The PVB group used placebo patches in addition to PVB the same way as TDF group. Postoperative pain was assessed with a visual analog scale (VAS) score up to 48 h. Intravenous morphine 0.1 mg/kg was given when the VAS is ≥ 3 or on patient request. The primary outcome measures were the time to first request for analgesia and the total analgesic consumption in the first 48 h.
RESULTS
Relative to the VAS score reading was 30 min. After the end of surgery, VAS score decreased significantly in the two groups up to 48 postoperative hours and was significantly lower in TDF group up to 24 h. The time to first request of additional analgesia was significantly longer, and total dose of morphine consumption was significantly lower in TDF group ( P < 0.001, and P = 0.039, respectively).
CONCLUSION
TFPs releasing 25 μg/h is a safe and effective adjuvant to PVB after breast cancer surgery. It provides adequate analgesia with reduction of opioid consumption and minimal adverse effects.",2017,"After the end of surgery, VAS score decreased significantly in the two groups up to 48 postoperative hours and was significantly lower in TDF group up to 24 h.","['pain control after breast cancer surgery', 'fifty females with breast cancer scheduled for surgery']","['placebo', 'bupivacaine', 'Intravenous morphine', 'transdermal fentanyl (TDF', 'TDF', 'Transdermal fentanyl']","['visual analog scale (VAS) score', 'time to first request for analgesia and the total analgesic consumption in the first 48 h.\nRESULTS\n\n\nRelative to the VAS score reading', 'VAS score', 'Postoperative pain', 'total dose of morphine consumption', 'time to first request of additional analgesia']","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",50.0,0.335612,"After the end of surgery, VAS score decreased significantly in the two groups up to 48 postoperative hours and was significantly lower in TDF group up to 24 h.","[{'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Bakeer', 'Affiliation': 'Department of Anaesthesia and Pain Relief, National Cancer Institute, Cairo University, Giza, Egypt.'}, {'ForeName': 'Nasr M', 'Initials': 'NM', 'LastName': 'Abdallah', 'Affiliation': 'Lecturer of Anesthesiology, Faculty of Medicine, Cairo University, Giza, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_84_17']
1742,29033717,"Comparison of oropharyngeal leak pressure of air-Q™, i-gel™, and laryngeal mask airway supreme™ in adult patients during general anesthesia: A randomized controlled trial.","STUDY OBJECTIVE
Various randomized controlled trials and a meta-analysis have compared i-gel™ and laryngeal mask airway Supreme™ (LMA-S™) in adult patients and found that both the devices provided equivalent oropharyngeal leak pressure (OLP). However, no randomized controlled trial has compared air-Q™ with i-gel™ and LMA-S™ in adult patient. Hence, we designed this study to compare air-Q™ with LMA-S™ and i-gel™ in adult patients.
MATERIALS AND METHODS
A total of 75 adult patients of the American Society of Anesthesiologists physical status I/II of both sexes, between 18 and 60 years, were included in this prospective randomized controlled trial conducted in a tertiary care center. Randomization of patients was done in three equal groups according to the insertion of supraglottic airway device by a computer-generated random number sequence: group air-Q™ ( n = 25), group i-gel™ ( n = 25), and group LMA-S™ ( n = 25). Primary outcome of this study was OLP. We also recorded time for successful placement of device, ease of device insertion, number of attempts to insert device, and ease of gastric tube insertion along with postoperative complications.
RESULTS
The mean ± standard deviation OLP of air-Q™, i-gel™, and LMA-S™ was 26.13 ± 4.957 cm, 23.75 ± 5.439 cm, and 24.80 ± 4.78 cm H 2 O ( P = 0.279). The first insertion success rate for air-Q™, i-gel™, and LMA-S™ was 80%, 76%, and 92%, respectively ( P = 0.353). The insertion time of air-Q™, i-gel™, and LMA-S™ was 20.6 ± 4.4, 14.8 ± 5.4, and 15.2 ± 4.7 s, respectively ( P = 0.000). Time taken for air-Q™ insertion was significantly higher than time taken for i-gel™ (mean difference 5.8 s, P < 0.0001) and LMA-S™ (mean difference 5.4 s, P = 0.0001) insertion. Postoperative complications were similar with all three devices.
CONCLUSIONS
We concluded that air-Q™, i-gel™, and LMA-S™ were equally efficacious in terms of routine airway management in adult patients with normal airway anatomy.",2017,"Time taken for air-Q™ insertion was significantly higher than time taken for i-gel™ (mean difference 5.8 s, P < 0.0001) and LMA-S™ (mean difference 5.4 s, P = 0.0001) insertion.","['75 adult patients of the American Society of Anesthesiologists physical status I/II of both sexes, between 18 and 60 years', 'adult patients with normal airway anatomy', 'adult patients during general anesthesia', 'adult patients']","['LMA-S™ and i-gel', 'oropharyngeal leak pressure of air-Q™, i-gel™, and laryngeal mask airway supreme', 'i-gel™ and laryngeal mask airway Supreme™ (LMA-S™', 'supraglottic airway device by a computer-generated random number sequence: group air-Q™ ( n = 25), group i-gel™']","['insertion time of air-Q', 'oropharyngeal leak pressure (OLP', 'Postoperative complications', 'mean ± standard deviation OLP of air-Q™, i-gel™, and LMA-S', 'Time taken for air-Q™ insertion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",75.0,0.230774,"Time taken for air-Q™ insertion was significantly higher than time taken for i-gel™ (mean difference 5.8 s, P < 0.0001) and LMA-S™ (mean difference 5.4 s, P = 0.0001) insertion.","[{'ForeName': 'Srinath', 'Initials': 'S', 'LastName': 'Damodaran', 'Affiliation': 'Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Surender Kumar', 'Initials': 'SK', 'LastName': 'Malhotra', 'Affiliation': 'Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Samra', 'Affiliation': 'Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Maitra', 'Affiliation': 'Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Saini', 'Affiliation': 'Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_149_17']
1743,29033720,"Reducing by 50% the incidence of maternal hypotension during elective caesarean delivery under spinal anesthesia: Effect of prophylactic ondansetron and/or continuous infusion of phenylephrine - a double-blind, randomized, placebo controlled trial.","BACKGROUND
Prophylactic administrations of ondansetron or phenylephrine have been reported to provide a protective effect against hypotension in women undergoing cesarean delivery under spinal anesthesia (SA). The main hypothesis is that ondansetron improves the hemodynamic response, especially combined with phenylephrine infusion.
METHODS
This prospective, double-blind, randomized, placebo-controlled study included 265 healthy pregnant women scheduled for elective cesarean delivery under SA. Women were randomly allocated into four groups to receive either placebo (control), ondansetron (O) 8 mg intravenously before induction of SA, phenylephrine infusion (50 mcg/min) (P) or ondansetron plus phenylephrine (OP). Demographic, obstetric, intraoperative timing, and anesthetic variables were assessed at 16 time points. Anesthetic variables assessed included blood pressure, heart rate, oxygen saturation, nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus, and vasopressor requirements.
RESULTS
There were differences ( P = 0.0001) in the number of patients with hypotension (50.8% control, 44.6% O, 20.9% P, 25.0% OP), the percentage of time points ( P = 0.0001) with systolic hypotension per patient (17.4% control, 8.7% O, 2.1% P, 6.7% OP) and the number of patients requiring supplementary boluses of ephedrine ( P = 0.003), phenylephrine ( P = 0.017) or atropine ( P = 0.0001).
CONCLUSIONS
A 50 μg/min phenylephrine infusion reduces by 50%, the incidence of maternal hypotension compared with placebo, but infusions of phenylephrine are still not routine in our environment. Prophylactic ondansetron 8 mg might be considered in this situation, because it does not reduce the incidence of maternal hypotension but diminishes its severity, reducing the number of hypotensive events per patient by 50%.",2017,"There were differences ( P = 0.0001) in the number of patients with hypotension (50.8% control, 44.6% O, 20.9% P, 25.0% OP), the percentage of time points ( P = 0.0001) with systolic hypotension per patient (17.4% control, 8.7% O, 2.1% P, 6.7% OP) and the number of patients requiring supplementary boluses of ephedrine ( P = 0.003), phenylephrine ( P = 0.017) or atropine ( P = 0.0001).
","['elective caesarean delivery under spinal anesthesia', '265 healthy pregnant women scheduled for elective cesarean delivery under SA', 'women undergoing cesarean delivery under spinal anesthesia (SA']","['placebo', 'phenylephrine', 'prophylactic ondansetron', 'placebo (control), ondansetron (O', 'ondansetron plus phenylephrine (OP', 'Prophylactic ondansetron', 'ephedrine', 'SA, phenylephrine infusion', 'ondansetron', 'atropine']","['hemodynamic response', 'Demographic, obstetric, intraoperative timing, and anesthetic variables', 'incidence of maternal hypotension', 'number of patients with hypotension', 'systolic hypotension', 'maternal hypotension', 'blood pressure, heart rate, oxygen saturation, nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus, and vasopressor requirements', 'percentage of time points']","[{'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",265.0,0.774846,"There were differences ( P = 0.0001) in the number of patients with hypotension (50.8% control, 44.6% O, 20.9% P, 25.0% OP), the percentage of time points ( P = 0.0001) with systolic hypotension per patient (17.4% control, 8.7% O, 2.1% P, 6.7% OP) and the number of patients requiring supplementary boluses of ephedrine ( P = 0.003), phenylephrine ( P = 0.017) or atropine ( P = 0.0001).
","[{'ForeName': 'Jose Ramon', 'Initials': 'JR', 'LastName': 'Ortiz-Gómez', 'Affiliation': 'Department of Anaesthesiology, Hospital Complex of Navarra, Pamplona, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Palacio-Abizanda', 'Affiliation': 'Department of Anaesthesiology, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Morillas-Ramirez', 'Affiliation': 'Department of Anaesthesiology, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'Inocencia', 'Initials': 'I', 'LastName': 'Fornet-Ruiz', 'Affiliation': 'Department of Anaesthesiology, Hospital Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lorenzo-Jiménez', 'Affiliation': 'Department of Anaesthesiology, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'Maria Lourdes', 'Initials': 'ML', 'LastName': 'Bermejo-Albares', 'Affiliation': 'Department of Anaesthesiology, Gregorio Marañón Hospital, Madrid, Spain.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_237_17']
1744,29033722,Effect of intravenous phenylephrine infusion on dose requirement of intrathecal plain levobupivacaine for cesarean section: A placebo-controlled preliminary study.,"BACKGROUND
Phenylephrine infusion has been shown to decrease rostral spread of plain and hyperbaric local anesthetic (LA) when compared to ephedrine infusion. However, it does not result in higher dose requirement of hyperbaric LA for cesarean section. There is no trial evaluating the effect of phenylephrine infusion on ED50 of a plain intrathecal LA.
METHODS
Pregnant patients with term uncomplicated singleton pregnancy undergoing elective cesarean section were given combined spinal-epidural anesthesia. They received intrathecal plain levobupivacaine 0.5% in a dose decided by up-and-down sequential allocation method along with 25 μg fentanyl. Intravenous infusion of phenylephrine (100 μg/ml) or normal saline was initiated immediately after intrathecal injection. Systolic arterial pressure ≤0.8 times baseline was treated using rescue boluses of phenylephrine 50 μg.
RESULTS
Demographic, other patient and surgical characteristics were similar in the two groups. ED50 of intrathecal plain levobupivacaine was significantly greater in phenylephrine group (5.5 mg [95% confidence interval (CI): 5.1-5.9 mg]) compared to saline group (4.2 mg [95% CI: 3.4-5.1 mg]) ( P = 0.01). Maximum sensory level, time to achieve adequate block, Apgar scores, and umbilical artery pH were similar in both groups. Total phenylephrine dose and patients having significant bradycardia were lesser in the saline group.
CONCLUSIONS
Intrathecal dose requirement of plain levobupivacaine is greater using phenylephrine infusion as compared to saline infusion with rescue phenylephrine boluses. When using phenylephrine as a variable dose regimen titrated to maintain blood pressure within 20% of baseline, the ED50 of plain levobupivacaine is 5.5 mg (95% CI: 5.1-5.9 mg).",2017,"Maximum sensory level, time to achieve adequate block, Apgar scores, and umbilical artery pH were similar in both groups.","['cesarean section', 'Pregnant patients with term uncomplicated singleton pregnancy undergoing elective cesarean section were given']","['intrathecal plain levobupivacaine', 'Total phenylephrine', 'placebo', 'phenylephrine', 'Phenylephrine infusion', 'normal saline', 'plain levobupivacaine', 'hyperbaric LA', 'ED50 of plain levobupivacaine', 'combined spinal-epidural anesthesia']","['Systolic arterial pressure', 'bradycardia', 'Maximum sensory level, time to achieve adequate block, Apgar scores, and umbilical artery pH', 'blood pressure']","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.551357,"Maximum sensory level, time to achieve adequate block, Apgar scores, and umbilical artery pH were similar in both groups.","[{'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Tyagi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Aanchal', 'Initials': 'A', 'LastName': 'Kakkar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Niwal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Mohta', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Sethi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_269_17']
1745,31524123,The effects of supplementing maternal and infant diets with lipid-based nutrient supplements on physical activity and sedentary behaviour at preschool age in Ghana.,"Evidence on whether nutritional supplementation affects physical activity (PA) during early childhood is limited. We examined the long-term effects of lipid-based nutrient supplements (LNS) on total PA, moderate-to-vigorous PA (MVPA) and sedentary behaviour (SB) of children at 4-6 years using an accelerometer for 1 week. Their mothers were enrolled in the International Lipid-based Nutrient Supplement-DYAD randomised controlled trial in Ghana, assigned to daily LNS or multiple micronutrients (MMN) during pregnancy through 6 months postpartum or Fe and folic acid (IFA) during pregnancy and placebo for 6 months postpartum. From 6 to 18 months, children in the LNS group received LNS; the other two groups received no supplements. Analysis was done with intention to treat comparing two groups: LNS v. non-LNS (MMN+ IFA). Of the sub-sample of 375 children fitted with accelerometers, 353 provided sufficient data. Median vector magnitude (VM) count was 1374 (interquartile range (IQR) 309), and percentages of time in MVPA and SB were 4·8 (IQR 2) and 31 (IQR 8) %, respectively. The LNS group (n 129) had lower VM (difference in mean -73 (95 % CI -20, -126), P = 0·007) and spent more time in SB (LNS v. non-LNS: 32·3 v. 30·5 %, P = 0·020) than the non-LNS group (n 224) but did not differ in MVPA (4·4 v. 4·7 %, P = 0·198). Contrary to expectations, provision of LNS in early life slightly reduced the total PA and increased the time in SB but did not affect time in MVPA. Given reduced social-emotional difficulties in the LNS group previously reported, including hyperactivity, one possible explanation is less restless movement in the LNS group.",2019,The LNS group (n 129) had lower VM (difference in mean -73,"['children at 4-6\xa0years using an accelerometer for 1\xa0week', '375 children fitted with accelerometers, 353 provided sufficient data', 'at preschool age in Ghana']","['LNS', 'LNS v. non-LNS (MMN+ IFA', 'lipid-based nutrient supplements (LNS', 'nutritional supplementation', 'supplementing maternal and infant diets with lipid-based nutrient supplements', 'LNS or multiple micronutrients (MMN) during pregnancy through 6 months postpartum or Fe and folic acid (IFA) during pregnancy and placebo']","['total PA, moderate-to-vigorous PA (MVPA) and sedentary behaviour (SB', 'physical activity and sedentary behaviour', 'percentages of time in MVPA and SB', 'social-emotional difficulties', 'physical activity (PA', 'spent more time in SB', 'Median vector magnitude (VM) count', 'time in SB', 'lower VM', 'total PA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0311143', 'cui_str': 'Infant diet'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",375.0,0.148214,The LNS group (n 129) had lower VM (difference in mean -73,"[{'ForeName': 'Maku E', 'Initials': 'ME', 'LastName': 'Ocansey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pulakka', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, 20014 Turku, Finland.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon 20520, Ghana.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Young', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Sika M', 'Initials': 'SM', 'LastName': 'Kumordzie', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Brietta M', 'Initials': 'BM', 'LastName': 'Oaks', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}]",The British journal of nutrition,['10.1017/S0007114519001636']
1746,29033724,"Comparison of laryngeal tube suction II and proseal LMA™ in pediatric patients, undergoing elective surgery.","BACKGROUND
Supraglottic airway devices now have an established place in pediatric anesthesia practice. The laryngeal tube suction (LTS) II, a recent revision of the LTS, has very few studies evaluating its use in pediatric patients. The aim of this study was to compare insertion and ventilation profiles of the LTS-II size 2 and the ProSeal™ Laryngeal Mask Airway (PLMA) size 2 in pediatric patients undergoing elective surgeries.
MATERIALS AND METHODS
A randomized prospective study was conducted in 100 children aged 2-5 years between 12 and 25 kg weight, of the American Society of Anesthesiologists physical status I and II scheduled for routine elective surgeries of <90 min duration. They were randomly divided into two groups of 50 each, depending on the device inserted, and a standard protocol for anesthesia was followed. Outcome measures were studied in terms of ease and time of insertion, oxygen saturation (SpO 2 ), oropharyngeal seal pressure (OSP), and ventilation failures.
RESULTS
Both groups were well matched in terms of age, weight, and type of surgery. The success rate for the first attempt was 90% for both the LTS-II group and PLMA group. Insertion was found to be easy in the majority of cases in both groups, and there was no statistical difference in blood pressure, heart rate, or SpO 2 on insertion. However, the OSP was significantly more in LTS-II and PLMA ( P < 0.001). There were no clinically important complications in the postoperative period.
CONCLUSIONS
Pediatric size 2 LTS-II is easy to insert and provides higher OSP compared with same size PLMA in anesthetized and paralyzed children undergoing elective surgery. It is a safe alternative to PLMA in short duration elective surgeries and may be a better device as it provides for higher OSPs.",2017,"Insertion was found to be easy in the majority of cases in both groups, and there was no statistical difference in blood pressure, heart rate, or SpO 2 on insertion.","['pediatric patients undergoing elective surgeries', 'pediatric patients, undergoing elective surgery', '100 children aged 2-5 years between 12 and 25 kg weight, of the American Society of Anesthesiologists physical status I and II scheduled for routine elective surgeries of <90 min duration', 'pediatric patients', 'anesthetized and paralyzed children undergoing elective surgery']","['laryngeal tube suction II and proseal LMA', 'laryngeal tube suction (LTS', 'PLMA', 'LTS-II size 2 and the ProSeal™ Laryngeal Mask Airway (PLMA) size 2']","['OSP', 'blood pressure, heart rate, or SpO 2 on insertion', 'success rate', 'ease and time of insertion, oxygen saturation (SpO 2 ), oropharyngeal seal pressure (OSP), and ventilation failures']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}]","[{'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",100.0,0.0406009,"Insertion was found to be easy in the majority of cases in both groups, and there was no statistical difference in blood pressure, heart rate, or SpO 2 on insertion.","[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Chandrakar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Army Hospital (Research and Referral), New Delhi, India.'}, {'ForeName': 'Deepak Kumar', 'Initials': 'DK', 'LastName': 'Sreevastava', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Army Hospital (Research and Referral), New Delhi, India.'}, {'ForeName': 'Sidharth', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Army Hospital (Research and Referral), New Delhi, India.'}, {'ForeName': 'Mridul', 'Initials': 'M', 'LastName': 'Dhar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Army Hospital (Research and Referral), New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_418_17']
1747,29033726,Ultrasound-guided multilevel paravertebral block versus local anesthesia for medical thoracoscopy.,"BACKGROUND
Local anesthetic infiltration for medical thoracoscopy has an analgesic properties for short duration. Single injection thoracic paravertebral block (PVB) provides limited analgesia.
PURPOSE
Comparison between thoracic PVB performed at two or three levels with local infiltration for anesthetic adequacy in adult medical thoracoscopy as a primary outcome and postthoracoscopic analgesia and pulmonary function as secondary outcomes for adult medical thoracoscopy.
PATIENTS AND METHODS
Prospective randomized control study included 63 adult patients with exudative pleural effusion randomly divided into three groups of 21 patients: 3-level PVB, 2-level PVB group, and local infiltration group. Patients with contraindications to regional anesthesia or uncontrolled comorbidities were excluded from the study. Pain visual analog scale and spirometry were used for comparison as anesthetic adequacy in adult medical thoracoscopy as a primary outcome besides prolonged analgesia and improved pulmonary function as secondary outcomes.
RESULTS
The anesthetic adequacy was 95.3% in 3-level PVB group, 81% in 2-level PVB group, and 71.5% in local infiltration group. The mean sensory level was 1 ± 0.8 and 1 ± 0.6 segment above and 0.8 ± 0.6 and 0.7 ± 0.7 segment below the injected level in 3-level PVB group and 2-level PVB, respectively. VAS was statistically significant higher in local infiltration compared to the other two groups immediately postthoracoscopic and 1 h after. Two-hour postthoracoscopy, significant increase in forced vital capacity values in the three groups compared to their basal values whereas forced expiratory volume at 1 s (FEV1) only in both PVB groups.
CONCLUSION
Unilateral 3-level TPVB was superior to 2-level TPVB and LA infiltration for anesthetic adequacy for patients undergoing medical thoracoscopy. Moreover, US-guided TPVB was followed by higher FEV1 values and lower pain scores during the next 12 h postthoracoscopy in comparison to local infiltration, so 3-level TPVB is an effective and relatively safe anesthetic technique for adult patients undergoing medical thoracoscopy which may replace local anesthesia.",2017,VAS was statistically significant higher in local infiltration compared to the other two groups immediately postthoracoscopic and 1 h after.,"['Patients with contraindications to regional anesthesia or uncontrolled comorbidities were excluded from the study', 'adult patients undergoing medical thoracoscopy which may replace local anesthesia', '63 adult patients with exudative pleural effusion randomly divided into three groups of 21 patients', 'adult medical thoracoscopy', 'patients undergoing medical thoracoscopy']","['Single injection thoracic paravertebral block (PVB', '3-level PVB, 2-level PVB group, and local infiltration group', 'Ultrasound-guided multilevel paravertebral block versus local anesthesia for medical thoracoscopy']","['anesthetic adequacy', 'forced vital capacity values', 'Pain visual analog scale and spirometry', 'local infiltration', 'pain scores', 'mean sensory level', 'VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C3887491', 'cui_str': 'Exudative pleural effusion (disorder)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}]",63.0,0.0256366,VAS was statistically significant higher in local infiltration compared to the other two groups immediately postthoracoscopic and 1 h after.,"[{'ForeName': 'Maha A', 'Initials': 'MA', 'LastName': 'Abo-Zeid', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohammad M', 'Initials': 'MM', 'LastName': 'Elgamal', 'Affiliation': 'Department of Chest Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Asem A', 'Initials': 'AA', 'LastName': 'Hewidy', 'Affiliation': 'Department of Chest Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Amro A', 'Initials': 'AA', 'LastName': 'Moawad', 'Affiliation': 'Department of Chest Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Alaa Eldin', 'Initials': 'AE', 'LastName': 'Adel Elmaddawy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_292_17']
1748,29033727,Ultrasound assessment of cranial spread during caudal blockade in children: Effect of different volumes of local anesthetic.,"BACKGROUND
Ultrasound-guided caudal block injection is a simple, safe, and effective method of anesthesia/analgesia in pediatric patients. The volume of caudal drug required has always been a matter of debate.
MATERIALS AND METHODS
This present prospective, randomized, double-blinded study aimed to measure extent of the cranial spread of caudally administered levobupivacaine in Indian children by means of real-time ultrasonography. Ninety American Society of Anesthesiologists I/II children scheduled for urogenital surgeries were enrolled in this trial. Anesthesia and caudal analgesia were administered in a standardized manner in the patients. The patients received 0.5 ml/kg or 1 ml/kg or 1.25 ml/kg of 0.125% levobupivacaine according to the group allocated. Cranial spread of local anesthetic was noted using ultrasound.
RESULTS
There was no difference in the spread when related to age, sex, weight, or body mass index. A significant difference of ultrasound-assessed cranial spread of the local anesthetic was found between Group 1 (0.5 ml/kg) with both Group 2 (1 ml/kg) ( P = 0.001) and with Group 3 (1.125 ml/kg) ( P < 0.001) but there is no significant difference between Group 2 and Group 3 ( P = 0.451) revealing that spinal level spread is only different between 0.5 ml/kg and 1 ml/kg of local anesthetic.
CONCLUSION
In conclusion, the ultrasound assessment of local anesthetic spread after a caudal block showed that cranial spread of the block is dependent on the volume injected into the caudal space. Since there was no difference between 1 ml/kg and 1.25 ml/kg, to achieve a dermatomal blockade up to thoracic level, we might have to increase the dose beyond 1.25 ml/kg, keeping the toxic dose in mind.",2017,"A significant difference of ultrasound-assessed cranial spread of the local anesthetic was found between Group 1 (0.5 ml/kg) with both Group 2 (1 ml/kg) ( P = 0.001) and with Group 3 (1.125 ml/kg) ( P < 0.001) but there is no significant difference between Group 2 and Group 3 ( P = 0.451) revealing that spinal level spread is only different between 0.5 ml/kg and 1 ml/kg of local anesthetic.
","['children', 'pediatric patients', 'I/II children scheduled for urogenital surgeries', 'Indian children by means of real-time ultrasonography', 'Ninety American Society of Anesthesiologists']","['Anesthesia and caudal analgesia', 'levobupivacaine', '0.5 ml/kg or 1 ml/kg or 1.25 ml/kg of 0.125% levobupivacaine']",['ultrasound-assessed cranial spread of the local anesthetic'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]",90.0,0.291385,"A significant difference of ultrasound-assessed cranial spread of the local anesthetic was found between Group 1 (0.5 ml/kg) with both Group 2 (1 ml/kg) ( P = 0.001) and with Group 3 (1.125 ml/kg) ( P < 0.001) but there is no significant difference between Group 2 and Group 3 ( P = 0.451) revealing that spinal level spread is only different between 0.5 ml/kg and 1 ml/kg of local anesthetic.
","[{'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Sinha', 'Affiliation': 'Department of Anesthesia, AIIMS, Patna, India.'}, {'ForeName': 'Amarjeet', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesia, AIIMS, Patna, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesia, AIIMS, Patna, India.'}, {'ForeName': 'Akhilesh Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesia, AIIMS, Patna, India.'}, {'ForeName': 'Somak', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Community and Family Medicine, AIIMS, Patna, India.'}, {'ForeName': 'Ajeet', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesia, AIIMS, New Delhi, India.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Sahay', 'Affiliation': 'Department of Anesthesia, AIIMS, Patna, India.'}, {'ForeName': 'Bindey', 'Initials': 'B', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatric Surgery, AIIMS, Patna, India.'}, {'ForeName': 'U K', 'Initials': 'UK', 'LastName': 'Bhadani', 'Affiliation': 'Department of Anesthesia, AIIMS, Patna, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_284_17']
1749,31592728,Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial.,"BACKGROUND
In patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared.
METHODS AND RESULTS
Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117-$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093-$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio <$50 000/QALY or <$150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy.
CONCLUSIONS
With an incremental cost-effectiveness ratio >$200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00790335.",2019,"Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point.","['patients with iliofemoral DVT', 'Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis', 'patients with acute deep vein thrombosis (DVT', '692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355', 'Patients With Proximal Deep Vein Thrombosis']","['Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis', 'Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation', 'pharmacomechanical catheter-directed thrombolysis (PCDT', 'PCDT']","['costs', 'Cost-Effectiveness', 'Utility scores', 'mean costs of the initial procedure', 'lifetime costs', 'Health state utilities', 'index hospitalization', 'incremental cost-effectiveness ratio for PCDT', 'lifetime incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",692.0,0.13536,"Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Khaja', 'Initials': 'K', 'LastName': 'Chinnakondepalli', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Vilain', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Thrombosis and Atherosclerosis Research Institute (C.K.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology (J.A.J.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Jewish General Hospital, Lady Davis Institute, Center for Clinical Epidemiology, Montreal, QC, Canada (S.R.K.).'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.Z.G.).""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Newton-Wellesley Hospital, Newton, MA (M.R.J.).'}, {'ForeName': 'Andrei L', 'Initials': 'AL', 'LastName': 'Kindzelski', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (A.L.K.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Herman', 'Affiliation': 'Interventional Institute at Holy Name Medical Center, Teaneck, NJ (K.H.).'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Brady', 'Affiliation': 'Thomas Jefferson University and Einstein Health Care Network, Philadelphia, PA (P.S.B.).'}, {'ForeName': 'Karun', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': ""Children's National Medical Center and George Washington University School of Medicine and Health Sciences, Washington, DC (K.S.).""}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Black', 'Affiliation': 'Utah Valley Hospital/Intermountain Healthcare and IVC Vein and Interventional Center, Provo (C.M.B.).'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, MO (S.V.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005659']
1750,31593484,Oxaliplatin-Based Adjuvant Chemotherapy for Rectal Cancer After Preoperative Chemoradiotherapy (ADORE): Long-Term Results of a Randomized Controlled Trial.,"PURPOSE
We evaluated the role of oxaliplatin as adjuvant chemotherapy in patients with rectal cancer who received preoperative chemoradiotherapy (CRT) with fluoropyrimidine monotherapy and total mesorectal excision (TME).
METHODS
The ADORE trial (adjuvant oxaliplatin in rectal cancer) is a multicenter, randomized trial in patients with postoperative ypStage II (ypT3-4N0) or III (ypT any N1-2) rectal cancer after fluoropyrimidine-based preoperative CRT and TME. Patients were randomly assigned (1:1) to receive adjuvant chemotherapy either with FL (fluorouracil 380 mg/m 2 and leucovorin 20 mg/m 2 ) or FOLFOX (oxaliplatin 85 mg/m 2 , leucovorin 200 mg/m 2 , and fluorouracil bolus 400 mg/m 2 on day 1, fluorouracil infusion 2,400 mg/m 2 for 46 hours). Stratification factors included ypStage and participating center. Primary end point was disease-free survival (DFS).
RESULTS
A total of 321 patients were enrolled between November 19, 2008, and June 12, 2012. Six-year DFS rates were 68.2% in the FOLFOX arm versus 56.8% in the FL arm, with a stratified hazard ratio of 0.63 (95% CI, 0.43 to 0.93; P = .018) by intention-to-treat analysis. In the subgroup analysis for DFS, FOLFOX was favorable versus FL in patients with ypStage III, ypN1b, ypN2, high-grade histology, minimally regressed tumor, and an absence of lymphovascular or perineural invasion. Six-year overall survival rate was 78.1% in the FOLFOX arm versus76.4% in the FL arm (hazard ratio, 0.73; 95% CI, 0.45 to 1.19; P = .21). In the subgroup analysis for OS, FOLFOX was favorable versus FL in patients with ypN2 and minimally regressed tumor.
CONCLUSION
Adjuvant FOLFOX improved DFS in patients with rectal cancer with ypStage II and III disease after preoperative CRT. Adjuvant FOLFOX may be considered on the basis of the postoperative pathologic stage in those who received preoperative CRT and TME.",2019,"In the subgroup analysis for DFS, FOLFOX was favorable versus FL in patients with ypStage III, ypN1b, ypN2, high-grade histology, minimally regressed tumor, and an absence of lymphovascular or perineural invasion.","['rectal cancer', '321 patients were enrolled between November 19, 2008, and June 12, 2012', 'patients with rectal cancer with ypStage II and III disease after preoperative CRT', 'patients with postoperative ypStage II (ypT3-4N0) or III', 'Rectal Cancer', 'patients with rectal cancer who received']","['adjuvant chemotherapy either with FL (fluorouracil 380 mg/m 2 and leucovorin 20 mg/m 2 ) or FOLFOX (oxaliplatin 85 mg/m 2 , leucovorin 200 mg/m 2 , and fluorouracil bolus 400', 'FOLFOX', 'Preoperative Chemoradiotherapy (ADORE', 'Oxaliplatin-Based Adjuvant Chemotherapy', 'preoperative chemoradiotherapy (CRT) with fluoropyrimidine monotherapy and total mesorectal excision (TME', 'fluorouracil', 'fluoropyrimidine-based preoperative CRT and TME', 'Adjuvant FOLFOX', 'oxaliplatin']","['Six-year overall survival rate', 'disease-free survival (DFS', 'Six-year DFS rates', 'DFS']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4276318', 'cui_str': 'Leucovorin 200 MG'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",321.0,0.157101,"In the subgroup analysis for DFS, FOLFOX was favorable versus FL in patients with ypStage III, ypN1b, ypN2, high-grade histology, minimally regressed tumor, and an absence of lymphovascular or perineural invasion.","[{'ForeName': 'Yong Sang', 'Initials': 'YS', 'LastName': 'Hong', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'The Institute of Advanced Clinical and Biomedical Research, Seoul, Republic of Korea.'}, {'ForeName': 'Kyu-Pyo', 'Initials': 'KP', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joon Oh', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Baek', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Joong Bae', 'Initials': 'JB', 'LastName': 'Ahn', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seok-Byung', 'Initials': 'SB', 'LastName': 'Lim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chang Sik', 'Initials': 'CS', 'LastName': 'Yu', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Cheon', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seong Hyeon', 'Initials': 'SH', 'LastName': 'Yun', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jong Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Hong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Chul', 'Initials': 'HC', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00016']
1751,31594469,"Working with memory: Computerized, adaptive working memory training for adolescents living with HIV.","This study investigated working memory (WM) training for adolescents with perinatal HIV infection, since WM is negatively impacted by the virus, and adolescence is a time of considerable brain reorganization, during which WM functioning reaches maturation. We posed three main questions: 1) whether WM could be trained in adolescents living with HIV, and if so, whether these effects were maintained over a six-month period during which no further training was received; 2) whether there were differential effects of training on the components of WM (verbal and visuospatial storage, verbal and visuospatial processing); 3) whether the WM training transferred to cognate tasks, and if so, whether these transfer effects were maintained over six months. Sixty-three HIV+ adolescents (10-16 years) from two children's homes were assigned to the training (n = 31) or control (n = 32) group. The training group received 32 hours of supervised training in an adaptive, computerized WM intervention, while the control group received a supervised, placebo computerized program for the same hours. Comprehensive WM and neuropsychological batteries were administered to both groups at pretest, immediately following the intervention, and six months later. Significant improvements were found in verbal WM for the training group, which were maintained six months later. Transfer effects were evident in attention, executive function, memory, language and fluid intelligence. There were no significant posttest improvements in visuospatial storage, and minimal changes in verbal storage and visuospatial WM. These findings represent an important step in exploring ways to improve cognitive functioning in an at-risk population.",2020,"There were no significant posttest improvements in visuospatial storage, and minimal changes in verbal storage and visuospatial WM.","[""Sixty-three HIV+ adolescents (10-16\xa0years) from two children's homes"", 'adolescents with perinatal HIV infection', 'adolescents living with HIV']","['working memory (WM) training', '32\xa0hours of supervised training in an adaptive, computerized WM intervention, while the control group received a supervised, placebo computerized program', 'WM', 'adaptive working memory training']","['verbal WM', 'cognitive functioning', 'attention, executive function, memory, language and fluid intelligence', 'visuospatial storage, and minimal changes in verbal storage and visuospatial WM']","[{'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442513', 'cui_str': ""Children's home (environment)""}, {'cui': 'C3160847', 'cui_str': 'Perinatal HIV infection'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0320129,"There were no significant posttest improvements in visuospatial storage, and minimal changes in verbal storage and visuospatial WM.","[{'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Fraser', 'Affiliation': 'Department of Psychology, School of Human and Community Development, University of the Witwatersrand , 2050, Johannesburg, South Africa.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cockcroft', 'Affiliation': 'Department of Psychology, School of Human and Community Development, University of the Witwatersrand , 2050, Johannesburg, South Africa.'}]",Child neuropsychology : a journal on normal and abnormal development in childhood and adolescence,['10.1080/09297049.2019.1676407']
1752,28966878,Digitizing Tablet and Fahn-Tolosa-Marín Ratings of Archimedes Spirals have Comparable Minimum Detectable Change in Essential Tremor.,"BACKGROUND
Drawing Archimedes spirals is a popular and valid method of assessing action tremor in the upper limbs. We performed the first blinded comparison of Fahn-Tolosa-Marín (FTM) ratings and tablet measures of essential tremor to determine if a digitizing tablet is better than 0-4 ratings in detecting changes in essential tremor that exceed random variability in tremor amplitude.
METHODS
The large and small spirals of FTM were drawn with each hand on two consecutive days by 14 men and four women (age 60±8.7 years [mean±SD]) with mild to severe essential tremor. The drawings were simultaneously digitized with a digitizing tablet. Tremor in each digitized drawing was computed with spectral analysis in an independent laboratory, blinded to the clinical ratings. The mean peak-to-peak tremor displacement (cm) in the four spirals and mean FTM ratings were compared statistically.
RESULTS
Test-retest intraclass correlations (ICCs) (two-way random single measures, absolute agreement) were excellent for the FTM ratings (ICC 0.90, 95% CI 0.76-0.96) and tablet (ICC 0.97, 95% CI 0.91-0.99). Log 10 tremor amplitude ( T ) and FTM were strongly correlated (log T =αFTM + β, α≈0.6, β≈-1.27, r=0.94). The minimum detectable change for the tablet and FTM were 51% and 67% of the initial assessment.
DISCUSSION
Digitizing tablets are much more precise than clinical ratings, but this advantage is mitigated by the natural variability in tremor. Nevertheless, the digitizing tablet is a robust method of quantifying tremor that can be used in lieu of or in combination with clinical ratings.",2017,"Log 10 tremor amplitude ( T ) and FTM were strongly correlated (log T =αFTM + β, α≈0.6, β≈-1.27, r=0.94).",['14 men and four women (age 60±8.7 years [mean±SD]) with mild to severe essential tremor'],['Fahn-Tolosa-Marín (FTM) ratings'],"['mean peak-to-peak tremor displacement (cm', 'Log 10 tremor amplitude ( T ) and FTM', 'Test-retest intraclass correlations (ICCs', 'FTM ratings', 'mean FTM ratings']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0270736', 'cui_str': 'Benign Essential Tremor'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}]",,0.0250491,"Log 10 tremor amplitude ( T ) and FTM were strongly correlated (log T =αFTM + β, α≈0.6, β≈-1.27, r=0.94).","[{'ForeName': 'Rodger J', 'Initials': 'RJ', 'LastName': 'Elble', 'Affiliation': 'Department of Neurology, Southern Illinois University School of Medicine, Springfield, IL, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ellenbogen', 'Affiliation': 'Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA.'}]","Tremor and other hyperkinetic movements (New York, N.Y.)",['10.7916/D89S20H7']
1753,31594205,Intra-articular distension preceded by physical therapy versus intra-articular distension followed by physical therapy for treating adhesive capsulitis of the shoulder.,"BACKGROUND
Intra-articular distension is a validated treatment in adhesive capsulitis of the shoulder and is commonly followed by intensive in-patient physical therapy. A recent meta-analysis found that physical therapy is as effective as intra-articular distension (IAD) and that an early distension could be the primary choice for treating frozen shoulder. The question of the additional contribution of physical therapy prior to IAD compared with IAD followed by physical therapy has not been raised.
OBJECTIVES
We compared IAD preceded by physical therapy to that followed by physical therapy in terms of pain relief and functional outcome.
METHODS
We enrolled patients with primitive adhesive capsulitis of the shoulder. The eligible patients were randomized into three groups: A, B and C. Group A received intra-articular distension followed by physical therapy, group B received intra-articular distension in the middle of physical therapy and group C received physical therapy alone. Patients were assessed at the beginning of the protocol (T0), after 6 weeks (T1) and after 12 weeks (T2). The main outcome measures were pain using a Visual Analog Scale and the Disabilities of Arm, Shoulder and Hand Questionnaire.
RESULTS
Out of the 179 enrolled patients, only 122 completed the follow up: group A (n= 34), group B (n= 46) and group C (n= 42). Compared to intra-articular distension preceded by physical therapy, IAD followed by physical therapy did not improve significantly the outcome in terms of pain relief (p= 0.123) but it enhanced the upper extremity function (p= 0.002). Upper extremity pain and function were found to improve with time regardless of the protocol (p< 0.001).
CONCLUSIONS
IAD followed by physical therapy is more beneficial than IAD preceded by physical therapy in terms of upper extremity function. IAD, whether or not preceded by physical therapy, does not significantly improve pain compared to physical therapy alone. Time is a crucial factor to take into consideration while treating adhesive capsulitis of the shoulder.",2020,"Upper extremity pain and function were found to improve with time regardless of the protocol (p< 0.001).
","['179 enrolled patients', 'enrolled patients with primitive adhesive capsulitis of the shoulder']","['physical therapy versus intra-articular distension followed by physical therapy', 'intra-articular distension followed by physical therapy, group B received intra-articular distension in the middle of physical therapy and group C received physical therapy alone']","['pain', 'pain relief and functional outcome', 'pain relief', 'upper extremity function', 'Upper extremity pain and function', 'pain using a Visual Analog Scale and the Disabilities of Arm, Shoulder and Hand Questionnaire']","[{'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3645627', 'cui_str': 'Primitive'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",179.0,0.0190494,"Upper extremity pain and function were found to improve with time regardless of the protocol (p< 0.001).
","[{'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Jellad', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Wafa', 'Initials': 'W', 'LastName': 'May', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zrig', 'Affiliation': 'Department of Radiology, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Kalai', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Mahbouba', 'Initials': 'M', 'LastName': 'Jguirim', 'Affiliation': 'Department of Rheumatology, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Zohra Ben Salah', 'Initials': 'ZBS', 'LastName': 'Frih', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Mondher', 'Initials': 'M', 'LastName': 'Golli', 'Affiliation': 'Department of Radiology, Faculty of Medicine, University Hospital of Monastir, University of Monastir, Monastir, Tunisia.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181426']
1754,31487406,"Efficacy and safety of tildrakizumab for plaque psoriasis with continuous dosing, treatment interruption, dose adjustments and switching from etanercept: results from phase III studies.","BACKGROUND
Chronic psoriasis may require medication adjustments over time.
OBJECTIVES
To evaluate the efficacy/safety of tildrakizumab in subgroups from the reSURFACE studies (N = 1862) that received continuous dosing, higher/lower dosing, treatment interruption/reinitiation and initiation.
METHODS
Responders [Psoriasis Area and Severity Index (PASI) ≥ 75%] and partial responders (PASI ≥ 50% to < 75%) in Part 3 of the reSURFACE studies (weeks 28-52 or week 64) who received tildrakizumab 200 mg or 100 mg were rerandomized to the same dosage (T100/T100 or T200/T200), a higher/lower dosage (T100/T200 or T200/T100) or placebo (PBO) (T100/PBO or T200/PBO). Patients receiving PBO who relapsed were reinitiated to tildrakizumab. Etanercept (ETN) week-28 partial responders and nonresponders (PASI < 50%) received tildrakizumab 200 mg (ETN/T200).
RESULTS
Among T100/T100 and T200/T200 week-28 partial responders, the proportion of patients who achieved as-observed PASI 75 responses increased over time. Among T100/T200 week-28 partial responders, PASI 75 responses increased from week 32 (38·5%) to week 52 (63·2%) and remained consistent in T200/T100 week-28 responders. Among patients who relapsed in the T100/PBO and T200/PBO groups, 86% and 83% of those who reinitiated tildrakizumab achieved PASI 75 by week 64, respectively. Among ETN/T200 week-28 partial responders, PASI 75 responses (nonresponder imputation) increased from week 32 (24·1%) to week 52 (74·7%). PASI 90, PASI 100 and Physician's Global Assessment responses were consistent with PASI 75 results. Treatment was well tolerated.
CONCLUSIONS
Patients generally fared well with tildrakizumab maintenance, reinitiation, dose adjustment or initiation. What's already known about this topic? Tildrakizumab demonstrated significant efficacy vs. placebo with a positive safety profile during the first 28 weeks of treatment in two randomized double-blind trials. What does this study add? Treatment scenarios with tildrakizumab, such as long-term continuous dosing (up to 64 weeks), treatment interruption/reinitiation and switching from another biologic, can be part of the management of plaque psoriasis with a reasonable expectation of efficacy and tolerability.",2020,"Among ETN/T200 Week 28 partial-responders, PASI 75 responses (non-responder imputation) increased from Weeks 32 (24.1%) to 52 (74.7%).",['Responders (PASI ≥75%) and partial-responders (PASI ≥50%-<75%) in Part 3 (Weeks 28-52 or 64) receiving'],"['tildrakizumab 200 or 100 mg were re-randomised to the same dose (T100/T100 or T200/T200), higher/lower dose (T100/T200 or T200/T100), or placebo (T100/PBO or T200/PBO', 'Etanercept', 'tildrakizumab']","['PASI 90, PASI 100, and PGA responses', 'PASI 75 responses', 'Efficacy and safety', 'tolerated']","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0289187,"Among ETN/T200 Week 28 partial-responders, PASI 75 responses (non-responder imputation) increased from Weeks 32 (24.1%) to 52 (74.7%).","[{'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Kimball', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'Skin Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Cichanowitz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'La Rosa', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18484']
1755,31596491,Association of Estimated Pulse Wave Velocity With Survival: A Secondary Analysis of SPRINT.,"Importance
Aortic stiffness, as assessed by carotid-femoral pulse wave velocity, is an independent predictor of future events in individuals with hypertension. Recent data suggest a predictive role of estimated pulse wave velocity (ePWV) calculated by previously published equations using age and blood pressure in future events in individuals with hypertension.
Objective
To investigate whether ePWV and its response to treatment predict survival in the Systolic Blood Pressure Intervention Trial (SPRINT).
Design, Setting, and Participants
This exploratory, hypothesis-generating, post hoc secondary analysis conducted from October 1, 2018, to August 31, 2019, examined data from 9361 participants in SPRINT and calculated ePWV at baseline and at 12 months. Adjusted hazard ratios (HRs) with 95% CIs of ePWV per 1 SD were estimated using Cox proportional hazards regression models. A total of 8450 patients were assigned to 4 groups according to their treatment allocation and their response in ePWV after 12 months.
Interventions
Participants were assigned a systolic blood pressure target of less than 120 mm Hg (intensive treatment) or less than 140 mm Hg (standard treatment).
Main Outcomes and Measures
The primary composite cardiovascular outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.
Results
In the SPRINT population (3332 women and 6029 men; mean [SD] age, 67.9 [9.4] years), ePWV predicted the primary outcome (HR, 1.30 [95% CI, 1.17-1.43]; P < .001) and all-cause death (HR, 1.65 [95% CI, 1.46-1.86]; P < .001) independent of the Framingham Risk Score. Estimated pulse wave velocity improved the C statistic model for the primary outcome from 0.676 (95% CI, 0.65-0.70) to 0.683 (95% CI, 0.66-0.71; P = .049) and improved the C statistic model for all-cause death from 0.67 (95% CI, 0.64-0.69) to 0.69 (95% CI, 0.66-0.72; P = .03). Net reclassification index indicated improvement in risk discrimination for survival compared with the Framingham Risk Score (categorical net reclassification index = 0.111; P < .001). Regarding response to treatment, intensive treatment was superior to standard treatment only when it was accompanied with a response in ePWV at the first year, while, within the standard treatment group, individuals whose ePWV responded to antihypertensive treatment had improved all-cause mortality, with a 42% lower risk of death compared with nonresponders (HR, 0.58 [95% CI, 0.36-0.94]; P = .03); effects were independent of changes in systolic blood pressure.
Conclusions and Relevance
These results suggest that, in the SPRINT trial, ePWV predicted outcomes independent of the Framingham Risk Score, indicating an incremental role of markers of aortic stiffness on cardiovascular risk. Better survival of individuals whose ePWV responded to antihypertensive treatment independently of systolic blood pressure reduction suggests a role of markers of aortic stiffness as effective treatment targets in individuals with hypertension.",2019,"Estimated pulse wave velocity improved the C statistic model for the primary outcome from 0.676 (95% CI, 0.65-0.70) to 0.683 (95% CI, 0.66-0.71; P = .049) and improved the C statistic model for all-cause death from 0.67 (95% CI, 0.64-0.69) to 0.69 (95% CI, 0.66-0.72; P = .03).","['individuals with hypertension', '8450 patients']",['systolic blood pressure target of less than 120 mm Hg (intensive treatment) or less than 140 mm Hg (standard treatment'],"['myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes', 'cause mortality', 'Estimated Pulse Wave Velocity With Survival', 'cardiovascular risk', 'C statistic model', 'risk of death', 'Adjusted hazard ratios (HRs', 'systolic blood pressure', 'risk discrimination for survival']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}]",3332.0,0.287451,"Estimated pulse wave velocity improved the C statistic model for the primary outcome from 0.676 (95% CI, 0.65-0.70) to 0.683 (95% CI, 0.66-0.71; P = .049) and improved the C statistic model for all-cause death from 0.67 (95% CI, 0.64-0.69) to 0.69 (95% CI, 0.66-0.72; P = .03).","[{'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Vlachopoulos', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Terentes-Printzios', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Laurent', 'Affiliation': 'Department of Pharmacology, European Georges Pompidou Hospital, Assistance Publique Hôpitaux de Paris, Inserm UMR 970, University Paris Descartes, Paris, France.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences, Lund University, University Hospital, Malmö, Sweden.'}, {'ForeName': 'Athanase D', 'Initials': 'AD', 'LastName': 'Protogerou', 'Affiliation': 'Cardiovascular Prevention and Research Unit, Clinic and Laboratory of Pathophysiology, Laiko Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Konstatinos', 'Initials': 'K', 'LastName': 'Aznaouridis', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Xaplanteris', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Iosif', 'Initials': 'I', 'LastName': 'Koutagiar', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Division of Preemptive Medicine for Vascular Damage, Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Division of Preemptive Medicine for Vascular Damage, Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Petros P', 'Initials': 'PP', 'LastName': 'Sfikakis', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.12831']
1756,30616442,Sex Hormones in Women With Elevated Breast Cancer Risk Undergoing Weight Loss.,"Sedentary lifestyles and obesity are known risk factors for breast cancer. Elevated estrogen levels correlate with obesity and, independently, with increased breast cancer risk. Lifestyle interventions that reduce obesity may mitigate this risk, potentially via estrogen pathways. In a 6-month lifestyle intervention, overweight/obese women with high breast cancer risk were randomized to control ( n = 7) or intervention ( n = 6) and analyzed for sex hormone levels. Serum and urine hormones were evaluated by ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and sex hormone binding globulin (SHBG) by enzyme-linked immunosorbent assay (ELISA). Serum estrone (E1) and estradiol (E2) were reduced by 12.1% and 50.8%, respectively, at 9 months in the intervention group, which differed from controls ( p = .043 and .020). This contrasted with a 73.3% increase in urine E1 at 6 months in the intervention group ( p = .035). These results suggest that a lifestyle intervention led to a favorable estrogen profile in relation to breast cancer risk.",2019,This contrasted with a 73.3% increase in urine E1 at 6 months in the intervention group ( p = .035).,"['Women With Elevated Breast Cancer Risk Undergoing Weight Loss', 'overweight/obese women with high breast cancer risk']",[],"['Serum and urine hormones', 'Serum estrone (E1) and estradiol (E2', 'urine E1']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]",,0.015685,This contrasted with a 73.3% increase in urine E1 at 6 months in the intervention group ( p = .035).,"[{'ForeName': 'Sophia A', 'Initials': 'SA', 'LastName': 'Stone', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Claire J', 'Initials': 'CJ', 'LastName': 'Han', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Taurence', 'Initials': 'T', 'LastName': 'Senn', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'Korde', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Allott', 'Affiliation': 'Dynamic Paths, Inc., Tacoma, WA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reding', 'Affiliation': 'Integrative Counseling Services, Seattle, WA, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Whittington', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kerryn W', 'Initials': 'KW', 'LastName': 'Reding', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}]",Western journal of nursing research,['10.1177/0193945918820672']
1757,31594719,Microdosing clinical study to clarify pharmacokinetic and pharmacogenetic characteristics of atorvastatin in Japanese hypercholesterolemic patients.,"The present study investigated whether the clinical pharmacokinetics of atorvastatin can be predicted from the results of microdosing study in Japanese patients with hypercholesterolemia whose SLCO1B1 and ABCG2 polymorphisms were analyzed. Forty seven statin-naive patients clinically indicated to LDL cholesterol-lowering therapy with atorvastatin were enrolled in a two-period crossover study. Microdose (100 μg) of atorvastatin was orally administered followed by therapeutic dose (10 mg) administration. Transport studies were performed with BCRP-expressing membrane vesicles. The dose-normalized plasma AUC following the therapeutic dose of atorvastatin was positively correlated with that following its microdose, but the AUC increased more than dose proportionally from microdose to therapeutic dose. The patients carrying SLCO1B1 c.521TC showed a significantly higher AUC compared with those carrying c.521TT following the microdose (175%) and therapeutic dose (139%). On the other hand, SLCO1B1 c.388G or ABCG2 c.421A variant alleles did not significantly affect the pharmacokinetics of atorvastatin. Atorvastatin showed ATP-dependent transport in BCRP-expressing membrane vesicles and it inhibited rosuvastatin transport with K i of 6.3 ± 2.9 μM (mean ± SD). Microdosing study appears to be feasible to roughly estimate the pharmacokinetic and pharmacogenetic profiles of atorvastatin following the oral therapeutic dose in hypercholesterolemic patients.",2019,The patients carrying SLCO1B1 c.521TC showed a significantly higher AUC compared with those carrying c.521TT following the microdose (175%) and therapeutic dose (139%).,"['Forty seven statin-naive patients clinically indicated to LDL cholesterol-lowering therapy with', 'hypercholesterolemic patients', 'Japanese hypercholesterolemic patients', 'Japanese patients with hypercholesterolemia whose SLCO1B1 and ABCG2 polymorphisms']","['Microdose', 'Atorvastatin', 'atorvastatin', 'μM']",['pharmacokinetics of atorvastatin'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]",47.0,0.0129083,The patients carrying SLCO1B1 c.521TC showed a significantly higher AUC compared with those carrying c.521TT following the microdose (175%) and therapeutic dose (139%).,"[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Sugiyama Laboratory, RIKEN Baton Zone Program, RIKEN Cluster for Science, Technology and Innovation Hub, RIKEN, 1-7-22 Suehiro-cho, Tsurumi-ku, Yokohama, Kanagawa, 230-0045, Japan; Life Science Research Institute, Daewoong Pharmaceutical, Co., Ltd., 72 Dugye-ro, Pogok-eup, Cheoin-gu, Yongin, 17028, South Korea.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7 Chome-3-1 Hongo, Bunkyo, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Fukizawa', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7 Chome-3-1 Hongo, Bunkyo, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Ieiri', 'Affiliation': 'Department of Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Tomaru', 'Affiliation': 'Sugiyama Laboratory, RIKEN Baton Zone Program, RIKEN Cluster for Science, Technology and Innovation Hub, RIKEN, 1-7-22 Suehiro-cho, Tsurumi-ku, Yokohama, Kanagawa, 230-0045, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Akao', 'Affiliation': 'Department of Cardiology, Kanazawa Medical University, 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa 920-0293, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Department of Cardiology, Kanazawa Medical University, 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa 920-0293, Japan.'}, {'ForeName': 'Mizuho', 'Initials': 'M', 'LastName': 'Iwadare', 'Affiliation': 'Department of Cardiology, Kanazawa Medical University, 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa 920-0293, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Niwa', 'Affiliation': 'Department of Pharmacy, Kanazawa Medical University Hospital, 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa 920-0293, Japan.'}, {'ForeName': 'Tougen', 'Initials': 'T', 'LastName': 'Masauji', 'Affiliation': 'Department of Pharmacy, Kanazawa Medical University Hospital, 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa 920-0293, Japan.'}, {'ForeName': 'Naoe', 'Initials': 'N', 'LastName': 'Yamane', 'Affiliation': 'CMIC Pharma Science Co., Ltd., Hamamatsu-Cho Building, 1-1-1, Shibaura, Minato-ku, Tokyo, 105-0023, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Kajinami', 'Affiliation': 'Department of Cardiology, Kanazawa Medical University, 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa 920-0293, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kusuhara', 'Affiliation': 'Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7 Chome-3-1 Hongo, Bunkyo, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Sugiyama', 'Affiliation': 'Sugiyama Laboratory, RIKEN Baton Zone Program, RIKEN Cluster for Science, Technology and Innovation Hub, RIKEN, 1-7-22 Suehiro-cho, Tsurumi-ku, Yokohama, Kanagawa, 230-0045, Japan. Electronic address: ychi.sugiyama@riken.jp.'}]",Drug metabolism and pharmacokinetics,['10.1016/j.dmpk.2019.08.004']
1758,30671682,"A Preliminary Randomized Controlled Trial of Game Plan, A Web Application to Help Men Who Have Sex with Men Reduce Their HIV Risk and Alcohol Use.","Alcohol use is a key risk factor for HIV infection among men who have sex with men (MSM). Past studies show that brief motivational interventions (BMI) can increase the use of prevention methods (e.g., condoms), reduce alcohol use, and can be adapted for web-based delivery. However, few studies have explored these interventions' effects in MSM. Forty high-risk, heavy drinking MSM who sought rapid HIV testing were randomly assigned to receive either (1) standard post-test counseling (SPC) alone, or (2) SPC plus Game Plan (GP), a tablet tablet-based BMI for alcohol use and HIV risk. Over three months of follow-up, GP participants reported 24% fewer heavy drinking days, 17% fewer alcohol problems, and 50% fewer new anal sex partners than controls. GP participants also reported fewer high-risk condomless anal sex events than controls, but these differences were not significant. These initial results suggest that web-based BMIs may be promising tools to help MSM reduce health risk behaviors.",2019,"Over three months of follow-up, GP participants reported 24% fewer heavy drinking days, 17% fewer alcohol problems, and 50% fewer new anal sex partners than controls.","['Forty high-risk, heavy drinking MSM who sought rapid HIV testing', 'men who have sex with men (MSM', 'Help Men']","['brief motivational interventions (BMI', 'standard post-test counseling (SPC) alone, or (2) SPC plus Game Plan (GP']","['new anal sex partners', 'high-risk condomless anal sex events', 'heavy drinking days']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",40.0,0.0311022,"Over three months of follow-up, GP participants reported 24% fewer heavy drinking days, 17% fewer alcohol problems, and 50% fewer new anal sex partners than controls.","[{'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Wray', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA. tyler_wray@brown.edu.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Simpanen', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02396-w']
1759,28024930,Urine Fibrosis Markers and Risk of Allograft Failure in Kidney Transplant Recipients: A Case-Cohort Ancillary Study of the FAVORIT Trial.,"BACKGROUND
Kidney tubulointerstitial fibrosis marks risk for allograft failure in kidney transplant recipients, but is poorly captured by estimated glomerular filtration rate (eGFR) or urine albumin-creatinine ratio (ACR). Whether urinary markers of tubulointerstitial fibrosis can noninvasively identify risk for allograft failure above and beyond eGFR and ACR is unknown.
STUDY DESIGN
Case-cohort study.
SETTING & PARTICIPANTS
The FAVORIT (Folic Acid for Vascular Outcome Reduction in Transplantation) Trial was a randomized double-blind trial testing vitamin therapy to lower homocysteine levels in stable kidney transplant recipients. We selected a subset of participants at random (n=491) and all individuals with allograft failure during follow-up (cases; n=257).
PREDICTOR
Using spot urine specimens from the baseline visit, we measured 4 urinary proteins known to correlate with tubulointerstitial fibrosis on biopsy (urine α 1 -microglobulin [A1M], monocyte chemoattractant protein 1 [MCP-1], and procollagen type III and type I amino-terminal amino pro-peptide).
OUTCOME
Death-censored allograft failure.
RESULTS
In models adjusted for demographics, chronic kidney disease risk factors, eGFR, and ACR, higher concentrations of urine A1M (HR per doubling, 1.73; 95% CI, 1.43-2.08) and MCP-1 (HR per doubling, 1.60; 95% CI, 1.32-1.93) were strongly associated with allograft failure. When additionally adjusted for concentrations of other urine fibrosis and several urine injury markers, urine A1M (HR per doubling, 1.76; 95% CI, 1.27-2.44]) and MCP-1 levels (HR per doubling, 1.49; 95% CI, 1.17-1.89) remained associated with allograft failure. Urine procollagen type III and type I levels were not associated with allograft failure.
LIMITATIONS
We lack kidney biopsy data, BK titers, and HLA antibody status.
CONCLUSIONS
Urine measurement of tubulointerstitial fibrosis may provide a noninvasive method to identify kidney transplant recipients at higher risk for future allograft failure, above and beyond eGFR and urine ACR.",2017,"CONCLUSIONS
Urine measurement of tubulointerstitial fibrosis may provide a noninvasive method to identify kidney transplant recipients at higher risk for future allograft failure, above and beyond eGFR and urine ACR.","['Transplantation', 'Case-cohort study', 'stable kidney transplant recipients', 'kidney transplant recipients', 'participants at random (n=491) and all individuals with allograft failure during follow-up (cases; n=257', 'Kidney Transplant Recipients']","['vitamin therapy', 'FAVORIT (Folic Acid']","['demographics, chronic kidney disease risk factors, eGFR, and ACR, higher concentrations of urine A1M', 'monocyte chemoattractant protein 1 [MCP-1], and procollagen type III and type', 'MCP-1', 'allograft failure', 'MCP-1 levels', 'glomerular filtration rate (eGFR) or urine albumin-creatinine ratio (ACR', 'Urine Fibrosis Markers and Risk of Allograft Failure', 'Urine procollagen type III and type', 'kidney biopsy data, BK titers, and HLA antibody status', 'homocysteine levels', 'Death-censored allograft failure', 'concentrations of other urine fibrosis and several urine injury markers, urine A1M']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042037'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0033240', 'cui_str': 'Type III Procollagen'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy (procedure)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",4.0,0.201796,"CONCLUSIONS
Urine measurement of tubulointerstitial fibrosis may provide a noninvasive method to identify kidney transplant recipients at higher risk for future allograft failure, above and beyond eGFR and urine ACR.","[{'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology-Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Nephrology Section, Veterans Affairs San Diego Healthcare System, San Diego, CA; Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA. Electronic address: joeix@ucsd.edu.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, WA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Bansal', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, WA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Tracy', 'Affiliation': 'Department of Pathology, University of Vermont, Burlington, VT.'}, {'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hughes-Austin', 'Affiliation': 'Department of Orthopedic Surgery, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'McKay', 'Affiliation': 'Division of Nephrology-Hypertension, Department of Medicine, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Gabbai', 'Affiliation': 'Division of Nephrology-Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Nephrology Section, Veterans Affairs San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Chi-Yuan', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bostom', 'Affiliation': 'Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Levey', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'General Internal Medicine Section, San Francisco Veterans Affairs Hospital, San Francisco, CA; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA; Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2016.10.019']
1760,31266035,Delayed Cord Clamping versus Early Cord Clamping in Elective Cesarean Section: A Randomized Controlled Trial.,"BACKGROUND
Delaying cord clamping is recommended in order to assure placental transfusion. However, the evidence on cord management in elective cesarean section (CS) is limited.
OBJECTIVE
To compare delayed cord clamping (DCC) with early cord clamping (ECC) with regard to postnatal adaptation in neonates born through elective CS.
METHODS
All neonates born ≥39 weeks' gestation born through elective CS were assigned to either the DCC or the ECC arm at a 1:1 ratio according to a computer-generated, randomized sequence. The primary outcome was the hematocrit at day 2 of life. Secondary outcomes included: preductal oxygen saturation and heart rate during the first 10 min of life; transcutaneous bilirubin at day 3; and neonatal blood pressures in the first 3 days of life. Additional outcomes included: time to first spontaneous breath; temperature at admission to normal nursery; weight at discharge; and maternal blood losses.
RESULTS
Eighty neonates were randomized to the DCC (n = 40) or the ECC (n = 40) arm. The hematocrit at day 2 was significantly higher in the DCC arm than in the ECC arm (mean difference: 6%; 95% CI 3-8; p < 0.0001). The secondary outcome measures were not statistically different between the two arms. No infants needed phototherapy for hyperbilirubinemia during their hospital stay.
CONCLUSIONS
Delaying cord clamping beyond 60 s increases the hematocrit at day 2 in neonates born through elective CS, without affecting maternal blood losses. Our findings suggest that DCC should be recommended in elective CS, but further studies are warranted to assess long-term outcomes.",2019,The hematocrit at day 2 was significantly higher in the DCC arm than in the ECC arm (mean difference: 6%; 95% CI 3-8; p < 0.0001).,"['Eighty neonates', 'neonates born through elective CS', ""All neonates born ≥39 weeks' gestation born through elective CS"", 'Elective Cesarean Section']","['delayed cord clamping (DCC) with early cord clamping (ECC', 'DCC or the ECC', 'DCC', 'Delayed Cord Clamping versus Early Cord Clamping', 'ECC']","['time to\xa0first spontaneous breath; temperature at admission to normal nursery; weight at discharge; and maternal blood losses', 'hematocrit at day 2 of life', 'maternal blood losses', 'preductal oxygen saturation and heart rate during the first 10 min of life; transcutaneous bilirubin at day 3; and neonatal blood pressures', 'hematocrit']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",80.0,0.263762,The hematocrit at day 2 was significantly higher in the DCC arm than in the ECC arm (mean difference: 6%; 95% CI 3-8; p < 0.0001).,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavallin', 'Affiliation': 'Independent Statistician, Solagna, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Galeazzo', 'Affiliation': ""Department of Women's and Children's Health, University of Padua, Padua, Italy.""}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Loretelli', 'Affiliation': ""Department of Women's and Children's Health, University of Padua, Padua, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Madella', 'Affiliation': ""Department of Women's and Children's Health, University of Padua, Padua, Italy.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pizzolato', 'Affiliation': ""Department of Women's and Children's Health, University of Padua, Padua, Italy.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Visentin', 'Affiliation': ""Department of Women's and Children's Health, University of Padua, Padua, Italy.""}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Trevisanuto', 'Affiliation': ""Department of Women's and Children's Health, University of Padua, Padua, Italy, daniele.trevisanuto@unipd.it.""}]",Neonatology,['10.1159/000500325']
1761,29137895,A Four-kallikrein Panel and β-Microseminoprotein in Predicting High-grade Prostate Cancer on Biopsy: An Independent Replication from the Finnish Section of the European Randomized Study of Screening for Prostate Cancer.,"BACKGROUND
A panel of four kallikrein markers (total, free, and intact prostate-specific antigen [PSA] and human kallikrein-related peptidase 2 [hK2]) improves predictive accuracy for Gleason score ≥7 (high-grade) prostate cancer among men biopsied for elevated PSA. A four-kallikrein panel model was originally developed and validated by the Dutch center of the European Randomized Study of Screening for Prostate Cancer (ERSPC). The kallikrein panel is now commercially available as 4Kscore™.
OBJECTIVE
To assess whether these findings could be replicated among participants in the Finnish section of ERSPC (FinRSPC) and whether β-microseminoprotein (MSP), a candidate prostate cancer biomarker, adds predictive value.
DESIGN, SETTING, AND PARTICIPANTS
Among 4861 biopsied screening-positive participants in the first three screening rounds of FinRSPC, a case-control subset was selected that included 1632 biopsy-positive cases matched by age at biopsy to biopsy-negative controls.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The predictive accuracy of prespecified prediction models was compared with biopsy outcomes.
RESULTS AND LIMITATIONS
Among men with PSA of 4.0-25ng/ml, 1111 had prostate cancer, 318 of whom had high-grade disease. Total PSA and age predicted high-grade cancer with an area under the curve of 0.648 (95% confidence interval [CI] 0.614-0.681) and the four-kallikrein panel increased discrimination to 0.746 (95% CI 0.717-0.774). Adding MSP to the four-kallikrein panel led to a significant (Wald test; p=0.015) but small increase (0.003) in discrimination. Limitations include a risk of verification bias among men with PSA of 3.0-3.99ng/ml and the absence of digital rectal examination results.
CONCLUSIONS
These findings provide additional evidence that kallikrein markers can be used to inform biopsy decision-making. Further studies are needed to define the role of MSP.
PATIENT SUMMARY
Four kallikrein markers and β-microseminoprotein in blood improve discrimination of high-grade prostate cancer at biopsy in men with elevated prostate-specific antigen.",2019,Adding MSP to the four-kallikrein panel led to a significant (Wald test; p=0.015) but small increase (0.003) in discrimination.,"['High-grade Prostate Cancer on Biopsy', 'men with PSA of 4.0-25ng/ml, 1111 had prostate cancer, 318 of whom had high-grade disease', 'Among 4861 biopsied screening-positive participants in the first three screening rounds of FinRSPC, a case-control subset was selected that included 1632 biopsy-positive cases matched by age at biopsy to biopsy-negative controls', 'participants in the Finnish section of ERSPC (FinRSPC) and whether', 'men with elevated prostate-specific antigen', 'men with PSA of 3.0-3.99ng/ml and the absence of digital rectal examination results']","['Four kallikrein markers and β-microseminoprotein', 'kallikrein Panel and β-Microseminoprotein', 'β-microseminoprotein (MSP']",['Total PSA and age predicted high-grade cancer'],"[{'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1384593', 'cui_str': 'Digital Rectal Examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0022478', 'cui_str': 'kallidinogenase'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",4861.0,0.0933331,Adding MSP to the four-kallikrein panel led to a significant (Wald test; p=0.015) but small increase (0.003) in discrimination.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Assel', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Sjöblom', 'Affiliation': 'Prostate Cancer Research Center, Institute of Biosciences and Medical Technology, University of Tampere, Tampere, Finland; Fimlab Laboratories, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu J', 'Initials': 'TJ', 'LastName': 'Murtola', 'Affiliation': 'Prostate Cancer Research Center, School of Health Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Fimlab Laboratories, Tampere University Hospital, Tampere, Finland; Department of Pathology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ulf-Håkan', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Clinical Chemistry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Prostate Cancer Research Center, School of Health Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vickers', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Visakorpi', 'Affiliation': 'Prostate Cancer Research Center, Institute of Biosciences and Medical Technology, University of Tampere, Tampere, Finland; Fimlab Laboratories, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'Prostate Cancer Research Center, School of Health Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lilja', 'Affiliation': 'Prostate Cancer Research Center, Institute of Biosciences and Medical Technology, University of Tampere, Tampere, Finland; Departments of Laboratory Medicine, Surgery, and Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Malmö, Sweden. Electronic address: liljah@mskcc.org.'}]",European urology focus,['10.1016/j.euf.2017.11.002']
1762,30951225,UV fluorescence excitation spectroscopy as a noninvasive predictor of epidermal proliferation and clinical performance of cosmetic formulations.,"BACKGROUND
The epidermis is the outermost layer of skin and is composed of cells primarily containing keratin. It consists of about ten layers of living cells (keratinocytes) and ten layers of dead cells (corneocytes). Thinning of the epidermis and decreased proliferation of its cells are associated with aging related changes in skin, including wrinkling and laxity. Fluorescence excitation spectroscopy is a noninvasive method of monitoring characteristic excitation-emission peaks in skin that have been related to the epidermal and dermal composition. The magnitude of the peak that occurs at 295nm excitation (F295) has been linked to changes in epidermal thickness, proliferation, and skin aging.
AIM
The goal of this study is to correlate changes in the F295 signal with proliferation of cells and thickening of the epidermis induced by cosmetic formulations. We hypothesize that two commonly used cosmetic ingredients, retinol and glycolic acid, will increase these markers that have been implicated in skin anti-aging.
METHODS
In a placebo-controlled study subjects' forearms were treated with formulations containing retinol or glycolic acid under occlusive patch for a period of 21 days. Skin fluorescence was measured at baseline and after treatment, and biopsies were taken following treatment for histological analysis of epidermal thickness and cell proliferation.
RESULTS
After 21 days of treatment retinol and glycolic acid formulas significantly increased F295 (by 265.1±33.5% and 162.2±18.7% respectively), whereas the placebo control formula did not induce a change from baseline. Furthermore, retinol and glycolic acid treatments significantly increased epidermal thickness (by 63.1% and 7.8% respectively) and keratinocyte proliferation (by 236.9% and 62.8% respectively) versus placebo control.
CONCLUSION
Increases in F295 were found to correlate with epidermal renewal, but more so with increased cell proliferation than epidermal thickness. We conclude that the F295 signal is a fast and reliable early indicator of epidermal remodeling in skin that can be used to distinguish between formulations with different cosmetic ingredients.",2019,"Increases in F295 were found to correlate with epidermal renewal, but more so with increased cell proliferation than epidermal thickness.","[""controlled study subjects' forearms""]","['UV fluorescence excitation spectroscopy', 'formulations containing retinol or glycolic acid', 'placebo']","['epidermal thickness', 'keratinocyte proliferation', 'cell proliferation', 'Skin fluorescence']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}]","[{'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C1533643', 'cui_str': 'glycolic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022567', 'cui_str': 'Keratinocyte (cell)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}]",,0.0678971,"Increases in F295 were found to correlate with epidermal renewal, but more so with increased cell proliferation than epidermal thickness.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Maidhof', 'Affiliation': 'Avon Products Inc, Suffern, New York.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Liebel', 'Affiliation': 'Avon Products Inc, Suffern, New York.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Hwang', 'Affiliation': 'Avon Products Inc, Suffern, New York.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ruvolo', 'Affiliation': 'Avon Products Inc, Suffern, New York.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lyga', 'Affiliation': 'Avon Products Inc, Suffern, New York.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12470']
1763,32412597,"Snacking on whole almonds for 6 weeks improves endothelial function and lowers LDL cholesterol but does not affect liver fat and other cardiometabolic risk factors in healthy adults: the ATTIS study, a randomized controlled trial.","BACKGROUND
There is convincing evidence that daily whole almond consumption lowers blood LDL cholesterol concentrations, but effects on other cardiometabolic risk factors such as endothelial function and liver fat are still to be determined.
OBJECTIVES
We aimed to investigate whether isoenergetic substitution of whole almonds for control snacks with the macronutrient profile of average snack intakes, had any impact on markers of cardiometabolic health in adults aged 30-70 y at above-average risk of cardiovascular disease (CVD).
METHODS
The study was a 6-wk randomized controlled, parallel-arm trial. Following a 2-wk run-in period consuming control snacks (mini-muffins), participants consumed either whole roasted almonds (n = 51) or control snacks (n = 56), providing 20% of daily estimated energy requirements. Endothelial function (flow-mediated dilation), liver fat (MRI/magnetic resonance spectroscopy), and secondary outcomes as markers of cardiometabolic disease risk were assessed at baseline and end point.
RESULTS
Almonds, compared with control, increased endothelium-dependent vasodilation (mean difference 4.1%-units of measurement; 95% CI: 2.2, 5.9), but there were no differences in liver fat between groups. Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability. However, the long-phase heart rate variability parameter, very-low-frequency power, was increased during nighttime following the almond treatment compared with control (mean difference 337 ms2; 95% CI: 12, 661), indicating greater parasympathetic regulation.
CONCLUSIONS
Whole almonds consumed as snacks markedly improve endothelial function, in addition to lowering LDL cholesterol, in adults with above-average risk of CVD.This trial was registered at clinicaltrials.gov as NCT02907684.",2020,"Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability.","['adults aged 30-70 y at above-average risk of cardiovascular disease (CVD', 'healthy adults']","['2-wk run-in period consuming control snacks (mini-muffins), participants consumed either whole roasted almonds (n\xa0=\xa051) or control snacks']","['liver fat', 'endothelial function', 'cardiometabolic health', 'blood LDL cholesterol concentrations', 'liver fat and other cardiometabolic risk factors', 'endothelial function and lowers LDL cholesterol', 'Endothelial function (flow-mediated dilation), liver fat (MRI/magnetic resonance spectroscopy', 'cardiometabolic disease risk', 'triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability', 'endothelium-dependent vasodilation', 'Plasma LDL cholesterol concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0452660', 'cui_str': 'Muffin'}, {'cui': 'C0440286', 'cui_str': 'Almond'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}]",,0.564696,"Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability.","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Dikariyanto', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Francis', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Eslem', 'Initials': 'E', 'LastName': 'Kusaslan', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': ""O'Callaghan-Latham"", 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Palanche', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Annibale"", 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Christodoulou', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Basty', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Whitcher', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Shuaib', 'Affiliation': ""Medical Physics, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Charles-Edwards', 'Affiliation': ""Medical Physics, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Chowienczyk', 'Affiliation': ""Department of Clinical Pharmacology, School of Cardiovascular Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ellis', 'Affiliation': ""Biopolymers Group, Departments of Biochemistry and Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sarah E E', 'Initials': 'SEE', 'LastName': 'Berry', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Diet and Cardiometabolic Health Research Group, Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa100']
1764,31368087,Impact of a Clinical Pharmacist Intervention on Medicine Costs in Patients with Chronic Obstructive Pulmonary Disease in India.,"BACKGROUND
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality, especially in low- and middle-income countries (LMICs) such as India. Medicine costs are a key issue in LMICs, with typically high patient co-payments. In addition, pharmacists are underutilised in LMICs, including India. However, pharmacist-led educational interventions may improve the care of patients with COPD, as well as reduce medicine costs. Consequently, the objective of this study was to assess the effectiveness of a pharmacist-led intervention in reducing medicine costs.
METHODOLOGY
We assessed the impact of a pharmacist intervention on direct medicine costs in COPD patients (medicine costs and pharmacist time) in a randomised controlled study involving an intervention and control group, conducted at a tertiary care teaching hospital in India.
RESULTS
The 6-monthly cost of medicines at baseline increased with disease severity, from a maximum of US$29.46 for those with mild COPD to US$63.28 for those with very severe COPD. Substantial savings in medical costs were achieved with the pharmacist-led programme, to a maximum of US$20.49 over 6 months for very severe patients. This equates to a reduction of 30.6% in medicine costs (p < 0.001), reduced to 26.1% when pharmacists' time (US$3.00/patient) was included.
CONCLUSION
There could be a key role for pharmacists as educators for COPD patients in LMICs, to improve care and reduce costs, including patient co-payments.",2020,"This equates to a reduction of 30.6% in medicine costs (p < 0.001), reduced to 26.1% when pharmacists' time (US$3.00/patient) was included.
","['Chronic obstructive pulmonary disease (COPD', 'Patients with Chronic Obstructive Pulmonary Disease in India', 'tertiary care teaching hospital in India', 'COPD patients (medicine costs and pharmacist time']","['pharmacist intervention', 'Clinical Pharmacist Intervention', 'pharmacist-led intervention']","['Medicine Costs', 'direct medicine costs']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]",,0.0921208,"This equates to a reduction of 30.6% in medicine costs (p < 0.001), reduced to 26.1% when pharmacists' time (US$3.00/patient) was included.
","[{'ForeName': 'Suhaj', 'Initials': 'S', 'LastName': 'Abdulsalim', 'Affiliation': 'Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia.'}, {'ForeName': 'Mazhuvancherry Kesavan', 'Initials': 'MK', 'LastName': 'Unnikrishnan', 'Affiliation': 'MCOPS, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Mohan K', 'Initials': 'MK', 'LastName': 'Manu', 'Affiliation': 'Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Saud', 'Initials': 'S', 'LastName': 'Alsahali', 'Affiliation': 'Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia.'}, {'ForeName': 'Alian A', 'Initials': 'AA', 'LastName': 'Alrasheedy', 'Affiliation': 'Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia.'}, {'ForeName': 'Antony P', 'Initials': 'AP', 'LastName': 'Martin', 'Affiliation': 'Health Economics Centre, University of Liverpool Management School, Liverpool, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Godman', 'Affiliation': 'Health Economics Centre, University of Liverpool Management School, Liverpool, UK. Brian.Godman@liverpool.ac.uk.'}, {'ForeName': 'Abubakr A', 'Initials': 'AA', 'LastName': 'Alfadl', 'Affiliation': 'Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia.'}]",PharmacoEconomics - open,['10.1007/s41669-019-0172-x']
1765,31152605,Population Pharmacokinetic Modeling and Exposure-Response Assessment for the Antibody-Drug Conjugate Brentuximab Vedotin in Hodgkin's Lymphoma in the Phase III ECHELON-1 Study.,"The efficacy of the CD30-directed antibody-drug conjugate (ADC) brentuximab vedotin was established in combination with chemotherapy as frontline treatment for advanced classical Hodgkin's lymphoma in the randomized phase III ECHELON-1 study. Population pharmacokinetic (PK) and exposure-response models were developed to quantify sources of PK variability and relationships between exposure and safety/efficacy end points in ECHELON-1. The influence of patient-specific factors on the PK of the ADC and the microtubule-disrupting payload monomethyl auristatin E (MMAE) was investigated; none of the significant covariates had a clinically relevant impact. Exposure-response analyses evaluated relationships between time-averaged area under the curve (AUC; ADC, MMAE) and efficacy end points (ADC) or safety parameters (ADC, MMAE). Exposure-efficacy analyses supported consistent treatment benefit with brentuximab vedotin across observed exposure ranges. Exposure-safety analyses supported the recommended brentuximab vedotin starting dose (1.2 mg/kg every 2 weeks), and effective management of peripheral neuropathy and neutropenia with dose modification/reduction and febrile neutropenia with granulocyte colony-stimulating factor primary prophylaxis.",2019,Exposure-efficacy analyses supported consistent treatment benefit with brentuximab vedotin across observed exposure ranges.,"[""advanced classical Hodgkin's lymphoma""]","['chemotherapy', 'granulocyte colony-stimulating factor primary prophylaxis', 'CD30-directed antibody-drug conjugate (ADC) brentuximab vedotin']","['time-averaged area under the curve (AUC; ADC, MMAE) and efficacy end points (ADC) or safety parameters (ADC, MMAE']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4704928', 'cui_str': 'Antibody-Drug Conjugates'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0192173,Exposure-efficacy analyses supported consistent treatment benefit with brentuximab vedotin across observed exposure ranges.,"[{'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Suri', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Mould', 'Affiliation': 'Projections Research, Inc., Phoenixville, Pennsylvania, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Collins', 'Affiliation': 'Oxford Cancer and Haematology Centre, Oxford University Hospital, Oxford, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Endres', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington, USA.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Gomez-Navarro', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1530']
1766,32412314,Randomized trial of electrodynamic microneedling combined with 5% minoxidil topical solution for treating androgenetic alopecia in Chinese males and molecular mechanistic study of the involvement of the Wnt/β-catenin signaling pathway.,"Background: Treatment of androgenetic alopecia (AGA) with concurrent electrodynamic microneedling and 5% minoxidil may further stimulate hair growth. Objectives: To evaluate the efficacy of microneedling combined with 5% minoxidil in Chinese male AGA patients and to explore the underlying mechanisms. Methods: Seventy-one male volunteers with AGA completed the entire trial and follow-up. The first group ( n = 23) received only 5% minoxidil twice daily for 24 weeks; the second group ( n = 23) received only microneedle therapy every 3 weeks for eight treatments; and the third group ( n = 25) received the combination treatment for a total of 24 weeks. Changes in hair density and diameter were evaluated before and after treatment every 3 weeks, and patients were followed up at 6 months after the final treatment. In the combination group, a PCR array was used to detect the expression of molecules in the Wnt/β-catenin pathway within the hair loss sites on top of the head before and after treatment and within the scalp tissues from non-hair loss sites on top of the head. The tissues were obtained by punches in the most severe area of hair loss on top of the head and in the adjacent normal hair area without hair loss. Real-time quantitative PCR and western blotting were used to further examine changes in the differentially expressed molecules identified by PCR array (FZD3) and in molecules in the Wnt/β-catenin signaling pathway closely related to hair growth (β-catenin and LEF-1). Results: Compared to single minoxidil or single microneedle treatment, the combination therapy showed superior therapeutic effects clinically, with further upregulation of FZD3, β-catenin, and LEF-1 expression levels at both mRNA and protein levels in the treated areas. Conclusions: Microneedling combined with 5% minoxidil can improve AGA, and the underlying mechanism may involve activation of the Wnt/β-catenin signaling pathway.",2020,"Compared to single minoxidil or single microneedle treatment, the combination therapy showed superior therapeutic effects clinically, with further upregulation of FZD3, β-catenin, and LEF-1 expression levels at both mRNA and protein levels in the treated areas.","['Chinese male AGA patients', 'Methods: Seventy-one male volunteers with AGA completed the entire trial and follow-up', 'androgenetic alopecia (AGA', 'Chinese males']","['concurrent electrodynamic microneedling and 5% minoxidil', 'minoxidil', 'microneedling combined with 5% minoxidil', 'electrodynamic microneedling combined with 5% minoxidil topical solution']","['FZD3, β-catenin, and LEF-1 expression levels', 'hair density and diameter']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0307514', 'cui_str': 'Minoxidil Topical Solution [Rogaine]'}]","[{'cui': 'C1175384', 'cui_str': 'FZD3 protein, human'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C1506866', 'cui_str': 'LEF1 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",71.0,0.023775,"Compared to single minoxidil or single microneedle treatment, the combination therapy showed superior therapeutic effects clinically, with further upregulation of FZD3, β-catenin, and LEF-1 expression levels at both mRNA and protein levels in the treated areas.","[{'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Bao', 'Affiliation': ""Department of Dermatology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, Shenzhen, China.""}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zong', 'Affiliation': 'Department of NICU, Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, China.'}, {'ForeName': 'Sining', 'Initials': 'S', 'LastName': 'Fang', 'Affiliation': ""Department of Dermatology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, Shenzhen, China.""}, {'ForeName': 'Lixiong', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""Department of Dermatology, Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University, Shenzhen, China.""}, {'ForeName': 'Yuanhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, The First Affiliated Hospital of China Medical University, Shenyang, China.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1770162']
1767,31195867,Efficacy comparison of titrated oral solution of misoprostol and intravenous oxytocin on labour induction in women with full-term pregnancy.,"A double-blind randomised trial was conducted on women with gestational age of 40-42 weeks of pregnancy and Bishop score of more than 5. The first group received oxytocin infusion and the second group received a titrated oral solution of misoprostol. Then, the two groups were compared by the primary outcome (the number of deliveries in the first 24 hours of intervention). The two groups did not have any significant difference in maternal and gestational age at the time of intervention, primary Bishop score, parity and neonatal weight. The number of deliveries in the first 24 hours was greater in the misoprostol group. Duration of onset of intervention to proper contractions was longer in the misoprostol group. However, the number of deliveries between 6-12 hours, 12-18 hours and 18-24 hours after induction was greater in the misoprostol group. The incidence of tachysystole and meconium was greater in the misoprostol group.Impact statement What is already known on this subject? Labour induction is widely used where the continuation of pregnancy might be dangerous for the mother or the baby. Of the various methods used for induction, misoprostol which is a prostaglandin E1 analogue has been reviewed more in recent years. Misoprostol has various routes of administration but in most studies only vaginal administration has been evaluated, leaving us with limited data about oral administration. What do the results of this study add? Oral misoprostol is a suitable method for labour induction and can be used as an alternative to oxytocin. What are the implications of these findings for clinical practice and/or further research? Misoprostol is not expensive, has a long shelf life, accessible in underdeveloped countries and rural areas and has several routes of administrations such as oral, sublingual and vaginal. Despite the fact that the oral route of misoprostol has a fast absorption and easier administration, there are relatively few studies assessing the the use of the oral route of misoprostol. Misoprostol is a suitable method for Labour induction and it has the potentials of being used as an alternative for oxytocin, however, the optimum dosages, the preferred route of administration, the maximum dose, the maximum time for administration, and maternal and neonatal safety should be studied more.",2020,"The two groups did not have any significant difference in maternal and gestational age at the time of intervention, primary Bishop score, parity and neonatal weight.","['women with full-term pregnancy', 'women with gestational age of 40-42\u2009weeks of pregnancy and Bishop score of more than 5']","['oxytocin infusion', 'Misoprostol', 'titrated oral solution of misoprostol', 'titrated oral solution of misoprostol and intravenous oxytocin', 'misoprostol', 'Oral misoprostol']","['labour induction', 'number of deliveries', 'maternal and gestational age at the time of intervention, primary Bishop score, parity and neonatal weight', 'incidence of tachysystole and meconium']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy (finding)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0025047', 'cui_str': 'Meconium'}]",,0.0465315,"The two groups did not have any significant difference in maternal and gestational age at the time of intervention, primary Bishop score, parity and neonatal weight.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kashanian', 'Affiliation': 'Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital, Tehran, Iran.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Eshraghi', 'Affiliation': 'Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Sheikhansari', 'Affiliation': 'Faculty of Medicine, University of Exeter, Exeter, UK.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Javanmanesh', 'Affiliation': 'Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital, Tehran, Iran.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1587598']
1768,28757828,Comparison of infracondylar versus subsartorial approach to saphenous nerve block: A randomized controlled study.,"BACKGROUND AND OBJECTIVES
Only a few different approaches are currently utilized for saphenous nerve block. Our study aimed to compare two different ultrasound (US)-guided saphenous nerve blocks and designed this study to test the hypothesis that the medial infracondylar approach has more success rate than the subsartorial approach applied in saphenous nerve blockage.
METHODS
The study included 76 patients (18-65 years old) with the American Society of Anesthesiologists physical status of I-III, who were scheduled for below-knee surgery by the orthopedics clinic. The patients who underwent US-guided saphenous nerve blockade were randomly divided into two groups: Group S (subsartorial approach) and Group M (medial infracondylar approach). For all patients who had a block procedure, the pinprick test was performed using a blunt needle on the saphenous nerve dermatome. Success rate, time of block performance (TBP), onset time of block (OTB), and duration of sensory blockade (DSB) were recorded using a patient follow-up form.
RESULTS
The US-guided saphenous nerve block success rate was similar (88% vs. 91%) or both techniques. The DSB values were 415.2 ± 65.3 min (95% confidence interval [CI]: 286.3-539.8) for Group S and 369.7 ± 52.2 min (95% CI: 265.6-467.8) for Group M ( P = 0.04), and no significant differences in the TBP and OTB were observed between the groups.
CONCLUSION
Both of the different anatomical approaches have equally high success rates. Although the DSB was found to be significantly longer in the subsartorial approach, this is clinically unimportant, and the medial infracondylar approach is still a viable alternative technique during saphenous nerve blockage.",2017,The US-guided saphenous nerve block success rate was similar (88% vs. 91%) or both techniques.,"['76 patients (18-65 years old) with the American Society of Anesthesiologists physical status of I-III, who were scheduled for below-knee surgery by the orthopedics clinic', 'patients who underwent US-guided saphenous nerve blockade', 'saphenous nerve block']","['ultrasound (US)-guided saphenous nerve blocks', 'Group S (subsartorial approach) and Group M (medial infracondylar approach', 'infracondylar versus subsartorial approach']","['DSB values', 'Success rate, time of block performance (TBP), onset time of block (OTB), and duration of sensory blockade (DSB', 'TBP and OTB', 'US-guided saphenous nerve block success rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic (environment)'}, {'cui': 'C0228919', 'cui_str': 'Structure of saphenous nerve'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0394744', 'cui_str': 'Local anesthetic saphenous nerve block (procedure)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394744', 'cui_str': 'Local anesthetic saphenous nerve block (procedure)'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}]","[{'cui': 'C0603200', 'cui_str': 'DSB'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0077021', 'cui_str': 'tributyl phosphate'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394744', 'cui_str': 'Local anesthetic saphenous nerve block (procedure)'}]",76.0,0.0582937,The US-guided saphenous nerve block success rate was similar (88% vs. 91%) or both techniques.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sahin', 'Affiliation': 'Department of Anesthesiology, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Eken', 'Affiliation': 'Department of Anesthesiology, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Isik', 'Affiliation': 'Department of Orthopedics, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Cavus', 'Affiliation': 'Department of Anesthesiology, The Ohio State University, Columbus, Ohio, USA.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_26_17']
1769,28757829,Effect of dexmedetomidine as an adjuvant to bupivacaine in femoral nerve block for perioperative analgesia in patients undergoing total knee replacement arthroplasty: A dose-response study.,"CONTEXT
Dexmedetomidine is being increasingly used in nerve blocks. However, there are only a few dose determination studies.
AIMS
To compare two doses of dexmedetomidine, in femoral nerve block, for postoperative analgesia after total knee arthroplasty (TKA).
SETTINGS AND DESIGN
A prospective, randomized, controlled trial was conducted in the Department of Anesthesia at AIIMS, a Tertiary Care Hospital.
MATERIALS AND METHODS
Sixty American Society of Anesthesiologists I-II patients undergoing TKA under subarachnoid block were randomized to three Groups A, B, and C. Control Group A received 20 ml (0.25%) of bupivacaine in femoral nerve block. Groups B and C received 1 and 2 μg/kg dexmedetomidine along with bupivacaine for the block, respectively. Outcomes measured were analgesic efficacy measured in terms of visual analog scale (VAS) score at rest and passive motion, duration of postoperative analgesia, and postoperative morphine consumption. Adverse effects of dexmedetomidine were also studied.
STATISTICAL ANALYSIS USED
All qualitative data were analyzed using Chi-square test and VAS scores using Kruskal-Wallis test. Comparison of patient-controlled analgesia (PCA) morphine consumption and time to first use of PCA were done using ANOVA followed by Least Significant Difference test. A P < 0.05 was considered statistically significant.
RESULTS
The VAS score at rest was significantly lower in Group C compared to Groups A and B ( P < 0.05). There was no difference in VAS score at motion between Groups B and C. The mean duration of analgesia was significantly longer in Group C (6.66 h) compared to Groups A (4.55 h) and B (5.70 h). Postoperative mean morphine consumption was significantly lower in Group C (22.85 mg) compared to Group A (32.15 mg) but was comparable to Group B (27.05 mg). There was no significant difference in adverse effects between the groups.
CONCLUSION
The use of dexmedetomidine at 2 μg/kg dose in femoral nerve block is superior to 1 μg/kg for providing analgesia after TKA, although its role in facilitating early ambulation needs further evaluation.",2017,The VAS score at rest was significantly lower in Group C compared to Groups A and B ( P < 0.05).,"['Department of Anesthesia at AIIMS, a Tertiary Care Hospital', 'Sixty American Society of Anesthesiologists I-II patients undergoing TKA under subarachnoid block', 'postoperative analgesia after total knee arthroplasty (TKA', 'patients undergoing total knee replacement arthroplasty']","['patient-controlled analgesia (PCA) morphine', 'Dexmedetomidine', 'bupivacaine', 'dexmedetomidine', 'C. Control Group']","['Postoperative mean morphine consumption', 'analgesic efficacy', 'adverse effects', 'VAS score', 'VAS score at rest', 'visual analog scale (VAS) score at rest and passive motion, duration of postoperative analgesia, and postoperative morphine consumption', 'mean duration of analgesia', 'Adverse effects']","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",60.0,0.176075,The VAS score at rest was significantly lower in Group C compared to Groups A and B ( P < 0.05).,"[{'ForeName': 'Senthil K', 'Initials': 'SK', 'LastName': 'Packiasabapathy', 'Affiliation': 'Department of Anaesthsia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Lokesh', 'Initials': 'L', 'LastName': 'Kashyap', 'Affiliation': 'Department of Anaesthsia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Mahesh K', 'Initials': 'MK', 'LastName': 'Arora', 'Affiliation': 'Department of Anaesthsia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravinder Kumar', 'Initials': 'RK', 'LastName': 'Batra', 'Affiliation': 'Department of Anaesthsia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Mohan', 'Affiliation': 'Department of Anaesthsia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ganga', 'Initials': 'G', 'LastName': 'Prasad', 'Affiliation': 'Department of Anaesthsia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Yadav', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_624_16']
1770,28757832,Sugammadex versus two doses of neostigmine for reversal of rocuronium in gastric sleeve surgery.,"BACKGROUND AND AIM
The aim of this prospective randomized trial is to compare the quality of reversal of rocuronium with either sugammadex (SUG) versus 2.5 mg or 5 mg neostigmine (NEO).
PATIENTS AND METHODS
A total of 110 patients with body mass index >40 underwent elective gastric sleeve surgery were enrolled in this study. Exclusion criteria included patients with co-existing muscular and cardiovascular diseases. Patients were randomly allocated to one of the following groups: group A (SUG), Group B (NEO 2.5 mg), and Group C (NEO 5 mg). General anesthesia was induced in the three groups using propofol 2.0 mg/kg of corrected body weight (CBW) and fentanyl 3 mcg/kg of CBW. Anesthesia was maintained with O 2 /air/desflurane 1 minimum alveolar concentration. Remifentanil infusion started at 0.05-0.2 mcg/kg/min. Tracheal intubation was facilitated with rocuronium 1.2 mg/kg of CBW guided with PNS. When the train of four (TOF) reached zero, intubation was performed using a GlideScope. At the end of surgery, TOF ratio and posttetanic counts were recorded. SUG 2 mg/kg of CBW (Group A), NEO 2.5 mg (Group B), and NEO 5 mg (Group C) were administered according to the random envelope. The time to achieve 90% of TOF was recorded in seconds using a timer. ANOVA for repeated measurements was used for statistical analyses. P <0.05 was considered statistically significant.
RESULTS
There was a positive correlation ( P < 0.05) between the duration of surgery and the time to reach 90% of TOF in all the three groups. The time to reach 90% TOF was significantly shorter with Group A versus Groups B and C ( P < 0.05).
CONCLUSION
Although SUG proved to be faster than NEO 5 mg in attaining TOF >90%, the recovery pattern of both was similar.",2017,"The time to reach 90% TOF was significantly shorter with Group A versus Groups B and C ( P < 0.05).
","['gastric sleeve surgery', '110 patients with body mass index >40 underwent elective gastric sleeve surgery', 'patients with co-existing muscular and cardiovascular diseases']","['CBW', 'neostigmine (NEO', 'Sugammadex', 'rocuronium with either sugammadex (SUG', 'propofol', 'Remifentanil', 'neostigmine', 'rocuronium', 'rocuronium 1.2 mg/kg of CBW guided with PNS']","['time to reach 90% TOF', 'time to achieve 90% of TOF', 'TOF ratio and posttetanic counts']","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",110.0,0.0521119,"The time to reach 90% TOF was significantly shorter with Group A versus Groups B and C ( P < 0.05).
","[{'ForeName': 'Abdulhamid', 'Initials': 'A', 'LastName': 'Alsaeed', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Bamehriz', 'Affiliation': 'Department of Surgery, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sharaf', 'Initials': 'S', 'LastName': 'Eldin', 'Affiliation': 'Department of Surgery, King Khaled University Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tareq', 'Initials': 'T', 'LastName': 'Alzahrani', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alharbi', 'Affiliation': 'Department of Surgery, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdelazeem', 'Initials': 'A', 'LastName': 'Eldawlatly', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_113_17']
1771,28757833,Using fentanyl and propofol for tracheal intubation during sevoflurane induction without muscle relaxants in children: A randomized prospective study.,"CONTEXT
Tracheal intubation is frequently facilitated with sevoflurane induction without the use of muscle relaxants in children.
AIM
The aim of this study was to compare the effects of two different doses of propofol preceded by a fixed dose of fentanyl during sevoflurane induction on quality of tracheal intubation in children.
SETTINGS AND DESIGN
This was a prospective randomized study.
SUBJECTS AND METHODS
Ninety American Society of Anesthesiologists I-II children aged 2-6 years were randomly assigned to one of two equal groups to receive 2 μg/kg of fentanyl with 2 mg/kg of propofol (Group I) or 2 μg/kg of fentanyl with 3 mg/kg of propofol (Group II) during sevoflurane induction. The intubating conditions and hemodynamic responses were evaluated. The time from sevoflurane induction to loss of consciousness, to intravenous line insertion, and to intubation was measured. The occurrence of any adverse effect was recorded.
STATISTICAL ANALYSIS USED
Results were analyzed using Student's t -test, paired t -test, and Chi-square test. P < 0.05 was considered statistically significant.
RESULTS
The incidence of excellent intubating conditions was achieved more significantly in Group II (41/45 patients, 91%) than that in Group I (31/45 patients, 69%) ( P = 0.008) (95% confidence interval [CI] =0.39-0.8). Whereas, there were no significant differences between the two groups in terms of the overall acceptable intubating conditions in Group I (40/45 patients, 89%) and Group II (43/45 patients, 96%) ( P = 0.81) (95% CI = 0.71-1.31). No patient developed any adverse effect.
CONCLUSION
The administration of 3 mg/kg propofol preceded by 2 μg/kg fentanyl provided a higher proportion of excellent intubating conditions compared with 2 mg/kg propofol preceded by 2 μg/kg fentanyl during sevoflurane induction in children without muscle relaxants.",2017,"The incidence of excellent intubating conditions was achieved more significantly in Group II (41/45 patients, 91%) than that in Group I (31/45 patients, 69%) ( P = 0.008) (95% confidence interval [CI] =0.39-0.8).","['children', 'Ninety American Society of Anesthesiologists I-II children aged 2-6 years', 'children without muscle relaxants']","['fentanyl with 2 mg/kg of propofol (Group I) or 2 μg/kg of fentanyl with 3 mg/kg of propofol', 'fentanyl', 'sevoflurane', 'propofol', 'sevoflurane induction', 'fentanyl and propofol']","['higher proportion of excellent intubating conditions', 'quality of tracheal intubation', 'intubating conditions and hemodynamic responses', 'incidence of excellent intubating conditions', 'overall acceptable intubating conditions', 'occurrence of any adverse effect', 'adverse effect']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",90.0,0.18746,"The incidence of excellent intubating conditions was achieved more significantly in Group II (41/45 patients, 91%) than that in Group I (31/45 patients, 69%) ( P = 0.008) (95% confidence interval [CI] =0.39-0.8).","[{'ForeName': 'Ashraf Arafat', 'Initials': 'AA', 'LastName': 'Abdelhalim', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'Hatem Hassan', 'Initials': 'HH', 'LastName': 'Maghraby', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Assiut University, Egypt.'}, {'ForeName': 'Ismail Ahmed', 'Initials': 'IA', 'LastName': 'ElZoughari', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Al-Azhar University, Egypt, Affiliated to King Saud University, Saudi Arabia.'}, {'ForeName': 'Tariq Abdullah', 'Initials': 'TA', 'LastName': 'AlZahrani', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohamed Sayed', 'Initials': 'MS', 'LastName': 'Moustafa', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Kamal Mohamed', 'Initials': 'KM', 'LastName': 'Alfassih', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulaziz Ejaz', 'Initials': 'AE', 'LastName': 'Ahmad', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, King Saud University, Riyadh, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.206802']
1772,28680361,Influence of Syrgical Trauma on Nitric Oxide and Nitrotyrosine Serum Levels in Patients Undergoing Laparoscopic Or Conventional Cholecystectomy.,"BACKGROUND
Oxidative stress represents tissue damage caused by reactive forms of oxygen and nitrogen due to the inability of antioxidant mechanisms to reduce reactive forms into more stable ones. The aim of the study was to evaluate the influence of surgical trauma on nitric oxide (NO) and nitrotyrosine (NT) values in patients undergoing conventional and laparoscopic cholecystectomy.
METHODS
A prospective study included sixty patients from the Department of Emergency Surgery, Clinical Centre of Serbia who were operated for gallstone related chronic cholecystitis. All the patients enrolled in the study underwent cholecystectomy; the first group was operated conventionally (30 patients - control group), while the second group was operated laparoscopically (30 patients - treatment group).
RESULTS
There were no statistically significant differences in the values of NO and its postoperative changes in both groups, the conventionally operated group (p=0.943) and the laparoscopically operated group (p=0.393). We found an increase in NT values 24 hours postoperatively (p=0.000) in the conventionally operated patients, while in the group operated laparoscopically we didn't find statistically significant changes in the values of NT (conventionally operated group (p=0.943) and laparoscopically operated group (p=0.393)).
CONCLUSIONS
In our study, we found a significant increase in NT values 24 hours postoperatively in conventionally operated patients i.e. the control group, vs. the treatment group. Further randomized studies are needed for a better understanding of the impact of surgical trauma on oxidative stress response.",2017,"There were no statistically significant differences in the values of NO and its postoperative changes in both groups, the conventionally operated group (p=0.943) and the laparoscopically operated group (p=0.393).","['sixty patients from the Department of Emergency Surgery, Clinical Centre of Serbia who were operated for gallstone related chronic cholecystitis', 'Patients Undergoing Laparoscopic Or Conventional Cholecystectomy', 'patients undergoing conventional and laparoscopic cholecystectomy']",['cholecystectomy'],"['values of NO and its postoperative changes', 'nitric oxide (NO) and nitrotyrosine (NT) values', 'NT values', 'values of NT', 'Nitric Oxide and Nitrotyrosine Serum Levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036708', 'cui_str': 'Serbia'}, {'cui': 'C0947622', 'cui_str': 'Cholecystolithiasis'}, {'cui': 'C0085694', 'cui_str': 'Chronic cholecystitis (disorder)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.0243677,"There were no statistically significant differences in the values of NO and its postoperative changes in both groups, the conventionally operated group (p=0.943) and the laparoscopically operated group (p=0.393).","[{'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Mijatović', 'Affiliation': 'Clinic for Emergency Surgery, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Alempijević', 'Affiliation': 'School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Branislava', 'Initials': 'B', 'LastName': 'Stefanović', 'Affiliation': 'School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Vasilije', 'Initials': 'V', 'LastName': 'Jeremić', 'Affiliation': 'Clinic for Emergency Surgery, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Krstić', 'Affiliation': 'Clinic for Emergency Surgery, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Radmanović', 'Affiliation': 'Clinic for Emergency Surgery, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Jovanović', 'Affiliation': 'Clinic for Emergency Surgery, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Branislav', 'Initials': 'B', 'LastName': 'Stefanović', 'Affiliation': 'Clinic for Emergency Surgery, Clinical Centre of Serbia, Belgrade, Serbia.'}]",Journal of medical biochemistry,['10.1515/jomb-2017-0004']
1773,28757824,Effects of preincisional analgesia with surgical site infiltration of ketamine or levobupivacaine in patients undergoing abdominal hysterectomy under general anesthesia; A randomized double blind study.,"CONTEXT
Postoperative pain management remains a cornerstone in patient's management to ensure a better quality of life. Preemptive analgesia is reported to inhibit the persistence of postoperative pain.
AIMS
The aim of this study is to assess the analgesic effectiveness of preincisional infiltration of ketamine following elective abdominal hysterectomy as compared to levobupivacaine.
SETTINGS AND DESIGN
This was a prospective, randomized, double-blind study.
SUBJECTS AND METHODS
This study included 48 patients undergoing abdominal hysterectomy under general anesthesia. They were randomized into two equal groups; Group K received subcutaneous infiltration of 20 ml containing ketamine 2 mg/kg and Group L received subcutaneous infiltration of 20 ml of levobupivacaine 0.25% along the Pfannenstiel incision 5 min before incision. Postoperative pain was assessed using visual analog scale (VAS) at rest and on coughing with evaluation of additional opioid analgesic requirements.
STATISTICAL ANALYSIS USED
Numerical variables were presented as mean and standard deviation or median and range as appropriate. The intergroup differences were compared using the independent-sample Student's t -test or Mann-Whitney test for numerical variables.
RESULTS
VAS score decreased significantly in Group L from 10 to 24 h and in Group K from 8 to 24 h as compared to the immediate postoperative reading. VAS score in ketamine group was significantly lower than that in the levobupivacaine group 8, 10, and 24 h postoperatively. Ketamine group showed delayed request of additional opioid analgesia ( P < 0.001) with significantly less opioid consumption ( P < 0.001) as compared to levobupivacaine. The total dose of meperidine consumed during the 24 postoperative h was significantly smaller in ketamine group ( P < 0.001).
CONCLUSION
Surgical site infiltration of ketamine is a promising preemptive analgesic method in the lower abdominal surgery with minimal sedation and adverse effects.",2017,"RESULTS
VAS score decreased significantly in Group L from 10 to 24 h and in Group K from 8 to 24 h as compared to the immediate postoperative reading.","['48 patients undergoing abdominal hysterectomy under general anesthesia', 'patients undergoing abdominal hysterectomy under general anesthesia']","['ketamine', 'meperidine', 'levobupivacaine', 'Ketamine', 'subcutaneous infiltration of 20 ml containing ketamine 2 mg/kg and Group L received subcutaneous infiltration of 20 ml of levobupivacaine 0.25% along the Pfannenstiel incision 5 min before incision', 'ketamine or levobupivacaine', 'preincisional analgesia']","['delayed request of additional opioid analgesia', 'opioid consumption', 'VAS score', 'visual analog scale (VAS', 'Postoperative pain', 'analgesic effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0441846', 'cui_str': 'Group L (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0457819', 'cui_str': 'Pfannenstiel incision (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",48.0,0.23528,"RESULTS
VAS score decreased significantly in Group L from 10 to 24 h and in Group K from 8 to 24 h as compared to the immediate postoperative reading.","[{'ForeName': 'Nasr Mahmoud', 'Initials': 'NM', 'LastName': 'Abdallah', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Giza Governorate, Egypt.'}, {'ForeName': 'Atef Kamel', 'Initials': 'AK', 'LastName': 'Salama', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Giza Governorate, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Ellithy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Giza, Giza Governorate, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.206794']
1774,28680344,"ADMA, SDMA and L-arginine may be Novel Targets in Pharmacotherapy for Complications due to Cardiopulmonary Bypass.","BACKGROUND
In this study, the effects of olmesartan therapy on asymmetric dimethylarginine (ADMA), symmetric dimethylarginine (SDMA), L-arginine and inducible nitric oxide synthase (iNOS) levels were investigated in patients undergoing cardiopulmonary bypass.
METHODS
Patients were randomly allocated to two groups, control and olmesartan. Olmesartan was administered 30 mg once a day beginning from preoperative day 5 to postoperative day 28 and on operation day. Blood was drawn from all patients and ADMA, SDMA, L-arginine and iNOS levels were analyzed at six time points (T1: before anesthesia induction, T2: during cardiopulmonary bypass, T3: five min after the cross-clamp was removed, T4: after protamine infusion, T5: on postoperative day 3 and T6: on postoperative day 28).
RESULTS
In the olmesartan treated group, iNOS levels exhibited significant decreases at T2, T3, T4, T5 and T6 time points compared with control group (p<0.001, p<0.05, p<0.001, p<0.01, p<0.05 respectively). ADMA levels were significantly lower in olmesartan treated group than in control group at T3, T4, T5 and T6 time points (p<0.05, p<0.05, p<0.05, p<0.01 respectively). SDMA levels at T2, T3 and T6 time points were higher in control group than olmesartan group. L-Arginine levels were significantly higher at T2 and T3 time points in olmesartan treated group than control group (p<0.001, p<0.01).
CONCLUSIONS
It was concluded that administration of olmesartan reduced plasma ADMA, SDMA, iNOS levels and enhanced L-arginine level in CPB time and it could reduce potential postoperative complications through reducing oxidative stress and inflammatory response in the postoperative period after coronary bypass surgery.",2017,"L-Arginine levels were significantly higher at T2 and T3 time points in olmesartan treated group than control group (p<0.001, p<0.01).
","['patients undergoing cardiopulmonary bypass', 'Patients']","['Olmesartan', 'olmesartan', 'olmesartan therapy', 'control and olmesartan']","['SDMA levels at T2, T3 and T6 time points', 'ADMA, SDMA, L-arginine and iNOS levels', 'plasma ADMA, SDMA, iNOS levels and enhanced L-arginine level', 'iNOS levels', 'L-Arginine levels', 'oxidative stress and inflammatory response', 'ADMA levels', 'asymmetric dimethylarginine (ADMA), symmetric dimethylarginine (SDMA), L-arginine and inducible nitric oxide synthase (iNOS) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C1098320', 'cui_str': 'olmesartan'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C0067305', 'cui_str': ""N,N'-dimethylarginine""}, {'cui': 'C1533698', 'cui_str': 'Nitric Oxide Synthase Type II'}]",,0.0340738,"L-Arginine levels were significantly higher at T2 and T3 time points in olmesartan treated group than control group (p<0.001, p<0.01).
","[{'ForeName': 'Aydın', 'Initials': 'A', 'LastName': 'Kahraman', 'Affiliation': 'Firat University, Faculty of Medicine, Department of Cardiovascular Surgery, Elazig, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Mutlu', 'Affiliation': 'Firat University, Faculty of Medicine, Department of Pharmacology, Elazig, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Aldağ', 'Affiliation': 'Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}]",Journal of medical biochemistry,['10.1515/jomb-2016-0025']
1775,28670189,"ACTH, Cortisol and IL-6 Levels in Athletes following Magnesium Supplementation.","BACKGROUND
Physical exercise activates the hypothalamo-pituitary-adrenal (HPA) axis and induces the body's inflammatory response. Due to contemporary dietary habits and increased energy expenditure, athletes are susceptible to depletion of magnesium ions. The aim of our study was to investigate, through assessment of plasma ACTH, serum IL-6, and salivary/serum cortisol levels, if chronic magnesium supplementation might reduce damaging stress effects in amateur rugby players.
METHODS
Rugby players (N=23) were randomly assigned to intervention and control group. Basal samples were collected before intervention group started a 4-week-long supplementation with magnesium (500 mg Mg/d). Blood and saliva sampling were done a day before the match (Day-1), on the morning of competition (Game), and during a six-day-long recovery period (Day1, Day3 and Day6). ACTH, serum/salivary cortisol, IL-6 and total/differential leukocytes counts were determined at each time point.
RESULTS
There was a statistically significant increase in ACTH concentration in intervention group compared to control group, while reductions in cortisol concentrations between the two groups were the greatest at Day-1 (p < 0.01) and at the day of competition (Game) (p < 0.01). Our results revealed that magnesium completely abolished the increase in IL-6 level noted in control group on Day1 and Day3 vs. Day-1 (p < 0.01) and also diminished the rise in neutrophil/lymphocyte ratio in intervention group vs. control group (p < 0.01).
CONCLUSIONS
These results suggest the possibly important influence magnesium supplementation might have on the change of parameters of HPA axis activity and reduction of immune response activation following strenuous physical exercise such as a rugby game.",2016,"There was a statistically significant increase in ACTH concentration in intervention group compared to control group, while reductions in cortisol concentrations between the two groups were the greatest at Day-1 (p < 0.01) and at the day of competition (Game) (p < 0.01).","['Athletes following Magnesium Supplementation', 'Rugby players (N=23', 'amateur rugby players']",['magnesium'],"['ACTH concentration', 'ACTH, serum/salivary cortisol, IL-6 and total/differential leukocytes counts', 'rise in neutrophil/lymphocyte ratio', 'Blood and saliva sampling', 'ACTH, Cortisol and IL-6 Levels', 'IL-6 level', 'cortisol concentrations', 'plasma ACTH, serum IL-6, and salivary/serum cortisol levels']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1096534', 'cui_str': 'Providing magnesium based on suboptimal food or fluid intake, iatrogenic deficiency or medical diagnosis. (Source: IDNT Reference Manual, edition 4; ISBN #978-0-88091-467-3)'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0162401', 'cui_str': 'Leukocyte Count, Differential'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}]",,0.0215968,"There was a statistically significant increase in ACTH concentration in intervention group compared to control group, while reductions in cortisol concentrations between the two groups were the greatest at Day-1 (p < 0.01) and at the day of competition (Game) (p < 0.01).","[{'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Dmitrašinović', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Pešić', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Dušanka', 'Initials': 'D', 'LastName': 'Stanić', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Bosiljka', 'Initials': 'B', 'LastName': 'Plećaš-Solarović', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Marijana', 'Initials': 'M', 'LastName': 'Dajak', 'Affiliation': 'Center for Medical Biochemistry, Clinical Center of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Ignjatović', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.'}]",Journal of medical biochemistry,['10.1515/jomb-2016-0021']
1776,31584682,Effect of Comprehensive Care Coordination on Medicaid Expenditures Compared With Usual Care Among Children and Youth With Chronic Disease: A Randomized Clinical Trial.,"Importance
Medicaid spending on children and young adults with chronic disease could be decreased through care coordination programs by reducing unnecessary hospital and emergency care.
Objective
To assess whether a comprehensive care coordination program reduces Medicaid expenditures by decreasing hospital and emergency department (ED) utilization.
Design, Setting, and Participants
This randomized clinical trial included 6259 children and young adults with chronic disease who received public insurance through Illinois Medicaid. In April 2016, eligible youth were randomized to receive comprehensive care coordination through the Coordinated Healthcare for Complex Kids (CHECK) program (n = 3126) or usual care (n = 3119) to measure the effect of the CHECK program on Medicaid expenditures and health care utilization using a difference-in-differences (DID) approach. Data were collected from May 1, 2014, to April 30, 2017, and analyzed in May 2018.
Interventions
Care coordination, mental health care, education, and social support were provided to CHECK participants and their family members. Services were tailored based on family and participant need.
Main Outcomes and Measures
Mean annual Medicaid expenditures, mean annual health care utilization by category (ED and inpatient), and chronic disease type and risk level.
Results
A total of 6259 participants (mean [SD] age, 11.3 [6.4] years; 2918 [46.6%] female; 2594 [41.4%] with medium and high risk) were randomized. Following the exclusion of 14 outliers, 6245 participants were analyzed. The mean (SD) annual Medicaid expenditure before the intervention was $1633 ($4006) for the intervention group and $1703 ($4466) for the usual care group, which decreased to a mean (SD) of $1341 ($3004) and $1413 ($3785), respectively, after the intervention (DID, -$1; 95% CI, -$199 to $196; P = .99). The mean (SD) inpatient utilization before the intervention was 63.0 (344.4) per 1000 person-years (PYs) for the intervention group and 69.3 (370.9) per 1000 PYs for the usual care group, which decreased to 43.5 (297.2) per 1000 PYs and 47.8 (304.9) per 1000 PYs, respectively, after the intervention (DID, 2.0; 95% CI, -17.9 to 21.8; P = .85). Among participants with asthma, those in the intervention group had a greater mean (SD) decrease in ED utilization compared with usual care, but the difference was not significant (-225.9 [65.3] vs -104.5 [80.0] visits per 1000 PY; DID, -121.5; 95% CI, -268.9 to 26.0; P = .11). Similarly, enrolled participants with sickle cell disease had a smaller but not significant mean (SD) increase in ED utilization compared with usual care (583.3 [839.0] vs 3761.9 [4611.2] visits per 1000 PYs; DID, -3178.6; 95% CI, -10 724.3 to 4367.2; P = .41).
Conclusions and Relevance
Overall Medicaid expenditures and health care utilization (hospital and ED) decreased similarly for both CHECK participants and the usual care group.
Trial Registration
ClinicalTrials.gov identifier: NCT04057521.",2019,"The mean (SD) annual Medicaid expenditure before the intervention was $1633 ($4006) for the intervention group and $1703 ($4466) for the usual care group, which decreased to a mean (SD) of $1341 ($3004) and $1413 ($3785), respectively, after the intervention (DID, -$1; 95% CI, -$199 to $196; P = .99).","['6245 participants were analyzed', 'Children and Youth With Chronic Disease', '6259 children and young adults with chronic disease who received public insurance through Illinois Medicaid', 'enrolled participants with sickle cell disease', 'In April 2016, eligible youth', '6259 participants (mean [SD] age, 11.3 [6.4] years; 2918 [46.6%] female; 2594 [41.4%] with medium and high risk', 'children and young adults with chronic disease']","['comprehensive care coordination through the Coordinated Healthcare for Complex Kids (CHECK) program (n\u2009=\u20093126) or usual care', 'comprehensive care coordination program', 'Usual Care', 'Comprehensive Care Coordination', 'CHECK program']","['ED utilization', 'mean (SD) annual Medicaid expenditure', 'greater mean (SD) decrease in ED utilization', 'Medicaid Expenditures', 'mean (SD) inpatient utilization', 'Mean annual Medicaid expenditures, mean annual health care utilization by category (ED and inpatient), and chronic disease type and risk level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0818338,"The mean (SD) annual Medicaid expenditure before the intervention was $1633 ($4006) for the intervention group and $1703 ($4466) for the usual care group, which decreased to a mean (SD) of $1341 ($3004) and $1413 ($3785), respectively, after the intervention (DID, -$1; 95% CI, -$199 to $196; P = .99).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Caskey', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago.'}, {'ForeName': 'Kellyn', 'Initials': 'K', 'LastName': 'Moran', 'Affiliation': 'College of Pharmacy, University of Illinois at Chicago.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Touchette', 'Affiliation': 'College of Pharmacy, University of Illinois at Chicago.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago.'}, {'ForeName': 'Garret', 'Initials': 'G', 'LastName': 'Munoz', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago.'}, {'ForeName': 'Pinal', 'Initials': 'P', 'LastName': 'Kanabar', 'Affiliation': 'Research Resource Center, University of Illinois at Chicago.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Van Voorhees', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.12604']
1777,28442955,No preemptive analgesic effect of preoperative ketorolac administration following total abdominal hysterectomy: A randomized study.,"BACKGROUND
Experimental models using short-duration noxious stimuli have led to the concept of preemptive analgesia. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to have a postoperative narcotic-sparing effect when given preoperatively and alternatively to not have this effect. This study was undertaken to determine whether a single intravenous (IV) dose of ketorolac would result in decreased postoperative pain and narcotic requirements.
METHODS
In a double-blind, randomized controlled trial, 48 women undergoing abdominal hysterectomy were studied. Patients in the ketorolac group received 30 mg of IV ketorolac 30 min before surgical incision, while the control group received normal saline. The postoperative analgesia was performed with a continuous infusion of tramadol at 12 mg/h with the possibility of a 10 mg bolus for every 10 min. Pain was assessed using the visual analog scale (VAS), tramadol consumption, and hemodynamic parameters at 0, 1, 2, 4, 8, 12, 16, and 24 h postoperatively. We quantified times to rescue analgesic (morphine), adverse effects, and patient satisfaction.
RESULTS
There were neither significant differences in VAS scores between groups ( P > 0.05) nor in the cumulative or incremental consumption of tramadol at any time point ( P > 0.05). The time to first requested rescue analgesia was 66.25 ± 38.61 min in the ketorolac group and 65 ± 28.86 min in the control group ( P = 0.765). There were no significant differences in systolic blood pressure (BP) between both groups, except at 2 h ( P = 0.02) and 4 h ( P = 0.045). There were no significant differences in diastolic BP between both groups, except at 4 h ( P = 0.013). The respiratory rate showed no differences between groups, except at 8 h ( P = 0.017), 16 h ( P = 0.011), and 24 h ( P = 0.049). These differences were not clinically significant. There were no statistically significant differences between groups in heart rate ( P > 0.05).
CONCLUSIONS
Preoperative ketorolac neither showed a preemptive analgesic effect nor was it effective as an adjuvant for decreasing opioid requirements or postoperative pain in patients receiving IV analgesia with tramadol after abdominal hysterectomy.",2017,"The respiratory rate showed no differences between groups, except at 8 h ( P = 0.017), 16 h ( P = 0.011), and 24 h ( P = 0.049).","['patients receiving IV analgesia with tramadol after abdominal hysterectomy', 'total abdominal hysterectomy', '48 women undergoing abdominal hysterectomy were studied']","['Ketorolac', 'IV ketorolac', 'tramadol', 'normal saline', 'ketorolac', 'preoperative ketorolac']","['heart rate', 'visual analog scale (VAS), tramadol consumption, and hemodynamic parameters', 'Pain', 'rescue analgesic (morphine), adverse effects, and patient satisfaction', 'respiratory rate', 'VAS scores', 'systolic blood pressure (BP', 'cumulative or incremental consumption of tramadol', 'diastolic BP', 'time to first requested rescue analgesia', 'postoperative pain and narcotic requirements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}]",48.0,0.291921,"The respiratory rate showed no differences between groups, except at 8 h ( P = 0.017), 16 h ( P = 0.011), and 24 h ( P = 0.049).","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Nistal-Nuño', 'Affiliation': 'Department of Cardiac and Thoracic Anesthesiology, The John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, United Kingdom.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.203011']
1778,28442956,"A comparison between intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy: A prospective, double-blind, randomized, placebo-controlled study.","BACKGROUND
Recently, there has been increasing interest in the use of analgesic adjuncts such as intravenous (IV) ketamine and lidocaine.
OBJECTIVES
To compare the effects of perioperative IV lidocaine and ketamine on morphine requirements, pain scores, quality of recovery, and chronic pain after open nephrectomy.
STUDY DESIGN
A prospective, randomized, placebo-controlled, double-blind trial.
SETTINGS
The study was conducted in Charles Nicolle University Hospital of Tunis.
METHODS
Sixty patients were randomly allocated to receive IV lidocaine: bolus of 1.5 mg/kg at the induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively or ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively or an equal volume of saline (control group [CG]).
MEASUREMENTS
Morphine consumption, visual analog scale pain scores, time to the first passage of flatus and feces, postoperative nausea and vomiting (PONV), 6-min walk distance (6MWD) at discharge, and the incidence of chronic neuropathic pain using the ""Neuropathic Pain Questionnaire"" at 3 months.
RESULTS
Ketamine and lidocaine reduced significantly morphine consumption (by about 33% and 42%, respectively) and pain scores compared with the CG ( P < 0.001). Lidocaine and ketamine also significantly improved bowel function in comparison to the CG ( P < 0.001). Ketamine failed to reduce the incidence of PONV. The 6 MWD increased significantly from a mean ± standard deviation of 27 ± 16.2 m in the CG to 82.3 ± 28 m in the lidocaine group ( P < 0.001). Lidocaine, but not ketamine, reduced significantly the development of neuropathic pain at 3 months ( P < 0.05).
CONCLUSION
Ketamine and lidocaine are safe and effective adjuvants to decrease opioid consumption and control early pain. We also suggest that lidocaine infusion serves as an interesting alternative to improve the functional walking capacity and prevent chronic neuropathic pain at 3 months after open nephrectomy.",2017,"Lidocaine, but not ketamine, reduced significantly the development of neuropathic pain at 3 months ( P < 0.05).
CONCLUSION
","['Sixty patients', 'Charles Nicolle University Hospital of Tunis', 'acute and chronic pain after open nephrectomy']","['ketamine', 'Lidocaine', 'placebo', 'lidocaine: bolus of 1.5 mg/kg at the induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively or ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively or an equal volume of saline (control group [CG', 'lidocaine', 'ketamine and lidocaine', 'Ketamine', 'perioperative IV lidocaine and ketamine', 'Lidocaine and ketamine']","['bowel function', 'morphine consumption', 'incidence of PONV', 'pain scores', 'chronic neuropathic pain', 'Morphine consumption, visual analog scale pain scores, time to the first passage of flatus and feces, postoperative nausea and vomiting (PONV), 6-min walk distance (6MWD) at discharge, and the incidence of chronic neuropathic pain using the ""Neuropathic Pain Questionnaire', 'morphine requirements, pain scores, quality of recovery, and chronic pain', 'neuropathic pain', 'opioid consumption and control early pain', 'functional walking capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0445341', 'cui_str': 'Tunis (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",60.0,0.376009,"Lidocaine, but not ketamine, reduced significantly the development of neuropathic pain at 3 months ( P < 0.05).
CONCLUSION
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jendoubi', 'Affiliation': 'Department of Anaesthesia and Intensive Care and Urology, Charles Nicolle Hospital of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Imed Ben', 'Initials': 'IB', 'LastName': 'Naceur', 'Affiliation': 'Department of Anaesthesia and Intensive Care and Urology, Charles Nicolle Hospital of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Abderrazak', 'Initials': 'A', 'LastName': 'Bouzouita', 'Affiliation': 'Department of Anaesthesia and Intensive Care and Urology, Charles Nicolle Hospital of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Trifa', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Children Hospital of Tunis, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Ghedira', 'Affiliation': 'Department of Anaesthesia and Intensive Care and Urology, Charles Nicolle Hospital of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Chebil', 'Affiliation': 'Department of Anaesthesia and Intensive Care and Urology, Charles Nicolle Hospital of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Houissa', 'Affiliation': 'Department of Anaesthesia and Intensive Care and Urology, Charles Nicolle Hospital of Tunis, Tunis, Tunisia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.203027']
1779,28442959,"Evaluation of different doses of dexmedetomidine alone versus the combination of dexmedetomidine and fentanyl in sedation during awake fiberoptic intubation in oral cancer surgery patients: A prospective, randomized, double-blind clinical trial.","BACKGROUND
Awake fiberoptic intubation (AFOI) is one of the principal techniques in the management of difficult airway in oral cancer surgery. We hypothesized that the addition of a small dose of fentanyl could improve the sedative criteria of dexmedetomidine during AFOI technique, without the need to increase the dose of dexmedetomidine which may be associated with airway compromise.
PATIENTS AND METHODS
One hundred and fifty American Society of Anesthesiologists physical status 1 and 2 patients planned for AFOI for oral cancer surgery patients were allocated into three groups (fifty patients each). Group D1: Received an infusion of 1 μcg/kg dexmedetomidine diluted in 50 ml saline over 20 min. Group D2: Received an infusion of 2 μcg/kg dexmedetomidine diluted in 50 ml saline over 20 min. Group DF: Received an infusion of 1 μcg/kg dexmedetomidine added to 1 μcg/kg fentanyl diluted in 50 ml saline over 20 min. AFOI was done by topical anesthesia and with the same technique in all patients. All patients were assessed for: airway obstruction, intubation scores (vocal cord movement, coughing, and limb movement), fiberoptic intubation scores, and hemodynamic variables. Any episode of bradycardia or hypoxia was recorded and managed.
RESULTS
Group D2 showed more incidence of airway obstruction than the other two groups. Limb movement scores were more in Group D1 compared to the other two groups. All groups were comparable as regard fiberoptic intubation scores, coughing, and vocal cord opening scores.
CONCLUSION
Adding a low dose of fentanyl (1 μcg/kg) to a low dose of dexmedetomidine can prevent the risk of airway obstruction associated with increasing the dose of dexmedetomidine while achieving the same favorable intubation scores.",2017,"All patients were assessed for: airway obstruction, intubation scores (vocal cord movement, coughing, and limb movement), fiberoptic intubation scores, and hemodynamic variables.","['One hundred and fifty American Society of Anesthesiologists physical status 1 and 2 patients planned for AFOI for oral cancer surgery patients', 'oral cancer surgery patients']","['fentanyl', 'infusion of 1 μcg/kg dexmedetomidine diluted in 50 ml saline', 'dexmedetomidine and fentanyl', 'dexmedetomidine', 'Awake fiberoptic intubation (AFOI', 'infusion of 2 μcg/kg dexmedetomidine']","['bradycardia or hypoxia', 'incidence of airway obstruction', 'Limb movement scores', 'airway obstruction, intubation scores (vocal cord movement, coughing, and limb movement), fiberoptic intubation scores, and hemodynamic variables', 'risk of airway obstruction', 'regard fiberoptic intubation scores, coughing, and vocal cord opening scores']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",150.0,0.463209,"All patients were assessed for: airway obstruction, intubation scores (vocal cord movement, coughing, and limb movement), fiberoptic intubation scores, and hemodynamic variables.","[{'ForeName': 'Mohamed Elsayed', 'Initials': 'ME', 'LastName': 'Hassan', 'Affiliation': 'Department of Anaesthesia, ICU, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Essam', 'Initials': 'E', 'LastName': 'Mahran', 'Affiliation': 'Department of Anaesthesia, ICU, National Cancer Institute, Cairo University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.203013']
1780,31433483,Cost-effectiveness of Housing First Intervention With Intensive Case Management Compared With Treatment as Usual for Homeless Adults With Mental Illness: Secondary Analysis of a Randomized Clinical Trial.,"Importance
In the At Home/Chez Soi trial for homeless individuals with mental illness, the scattered-site Housing First (HF) with Intensive Case Management (ICM) intervention proved more effective than treatment as usual (TAU).
Objective
To evaluate the cost-effectiveness of the HF plus ICM intervention compared with TAU.
Design, Setting, and Participants
This is an economic evaluation study of data from the At Home/Chez Soi randomized clinical trial. From October 2009 through July 2011, 1198 individuals were randomized to the intervention (n = 689) or TAU (n = 509) and followed up for as long as 24 months. Participants were recruited in the Canadian cities of Vancouver, Winnipeg, Toronto, and Montreal. Participants with a current mental disorder who were homeless and had a moderate level of need were included. Data were analyzed from 2013 through 2019, per protocol.
Interventions
Scattered-site HF (using rent supplements) with off-site ICM services was compared with usual housing and support services in each city.
Main Outcomes and Measures
The analysis was performed from the perspective of society, with days of stable housing as the outcome. Service use was ascertained using questionnaires. Unit costs were estimated in 2016 Canadian dollars.
Results
Of 1198 randomized individuals, 795 (66.4%) were men and 696 (58.1%) were aged 30 to 49 years. Almost all (1160 participants, including 677 in the HF group and 483 in the TAU group) contributed data to the economic analysis. Days of stable housing were higher by 140.34 days (95% CI, 128.14-153.31 days) in the HF group. The intervention cost $14 496 per person per year; reductions in costs of other services brought the net cost down by 46% to $7868 (95% CI, $4409-$11 405). The incremental cost-effectiveness ratio was $56.08 (95% CI, $29.55-$84.78) per additional day of stable housing. In sensitivity analyses, adjusting for baseline differences using a regression-based method, without altering the discount rate, caused the largest change in the incremental cost-effectiveness ratio with an increase to $60.18 (95% CI, $35.27-$86.95). At $67 per day of stable housing, there was an 80% chance that HF was cost-effective compared with TAU. The cost-effectiveness of HF appeared to be similar for all participants, although possibly less for those with a higher number of previous psychiatric hospitalizations.
Conclusions and Relevance
In this study, the cost per additional day of stable housing was similar to that of many interventions for homeless individuals. Based on these results, expanding access to HF with ICM appears to be warranted from an economic standpoint.
Trial Registration
isrctn.org Identifier: ISRCTN42520374.",2019,"Days of stable housing were higher by 140.34 days (95% CI, 128.14-153.31 days) in the HF group.","['homeless individuals', 'Participants were recruited in the Canadian cities of Vancouver, Winnipeg, Toronto, and Montreal', '1198 randomized individuals, 795 (66.4%) were men and 696 (58.1%) were aged 30 to 49 years', 'Homeless Adults With Mental Illness', 'From October 2009 through July 2011, 1198 individuals', '1160 participants, including 677 in the HF group and 483 in the TAU group) contributed data to the economic analysis', 'homeless individuals with mental illness', 'Participants with a current mental disorder who were homeless and had a moderate level of need were included']","['HF plus ICM intervention', 'Housing First Intervention With Intensive Case Management', 'Intensive Case Management (ICM) intervention', 'TAU']","['Cost-effectiveness', 'incremental cost-effectiveness ratio', 'Unit costs', 'cost-effectiveness of HF', 'cost-effectiveness']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1198.0,0.202438,"Days of stable housing were higher by 140.34 days (95% CI, 128.14-153.31 days) in the HF group.","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Latimer', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rabouin', 'Affiliation': 'Douglas Research Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': 'Douglas Research Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ly', 'Affiliation': 'Montreal West Island Integrated University Health and Social Services Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Powell', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Adair', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jitender', 'Initials': 'J', 'LastName': 'Sareen', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Somers', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Pinto', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erica E M', 'Initials': 'EEM', 'LastName': 'Moodie', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Veldhuizen', 'Affiliation': 'Centre for Addiction and Mental Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2019.9782']
1781,31811128,Resolving the cause of recurrent Plasmodium vivax malaria probabilistically.,"Relapses arising from dormant liver-stage Plasmodium vivax parasites (hypnozoites) are a major cause of vivax malaria. However, in endemic areas, a recurrent blood-stage infection following treatment can be hypnozoite-derived (relapse), a blood-stage treatment failure (recrudescence), or a newly acquired infection (reinfection). Each of these requires a different prevention strategy, but it was not previously possible to distinguish between them reliably. We show that individual vivax malaria recurrences can be characterised probabilistically by combined modelling of time-to-event and genetic data within a framework incorporating identity-by-descent. Analysis of pooled patient data on 1441 recurrent P. vivax infections in 1299 patients on the Thailand-Myanmar border observed over 1000 patient follow-up years shows that, without primaquine radical curative treatment, 3 in 4 patients relapse. In contrast, after supervised high-dose primaquine only 1 in 40 relapse. In this region of frequent relapsing P. vivax, failure rates after supervised high-dose primaquine are significantly lower (∼3%) than estimated previously.",2019,"Analysis of pooled patient data on 1441 recurrent P. vivax infections in 1299 patients on the Thailand-Myanmar border observed over 1000 patient follow-up years shows that, without primaquine radical curative treatment, 3 in 4 patients relapse.",['1299 patients on the Thailand-Myanmar border observed over 1000\xa0patient follow-up years'],"['primaquine', 'primaquine radical curative']",['failure rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.0710095,"Analysis of pooled patient data on 1441 recurrent P. vivax infections in 1299 patients on the Thailand-Myanmar border observed over 1000 patient follow-up years shows that, without primaquine radical curative treatment, 3 in 4 patients relapse.","[{'ForeName': 'Aimee R', 'Initials': 'AR', 'LastName': 'Taylor', 'Affiliation': 'Center for Communicable Disease Dynamics, Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, 02115, USA. ataylor@hsph.harvard.edu.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Watson', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand. jwatowatson@gmail.com.'}, {'ForeName': 'Cindy S', 'Initials': 'CS', 'LastName': 'Chu', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, OX3 7FZ, UK.'}, {'ForeName': 'Kanokpich', 'Initials': 'K', 'LastName': 'Puaprasert', 'Affiliation': 'Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Jureeporn', 'Initials': 'J', 'LastName': 'Duanguppama', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Nosten', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, OX3 7FZ, UK.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Neafsey', 'Affiliation': 'Broad Institute of MIT and Harvard, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Buckee', 'Affiliation': 'Center for Communicable Disease Dynamics, Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, 02115, USA.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Imwong', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand. nickwdt@tropmedres.ac.'}]",Nature communications,['10.1038/s41467-019-13412-x']
1782,30153360,Feasibility of Computerized Cognitive-Behavioral Therapy Combined With Bifrontal Transcranial Direct Current Stimulation for Treatment of Major Depression.,"BACKGROUND
Cognitive behavioral therapy (CBT) is effective in the treatment of major depressive disorder (MDD). Transcranial Direct Current Stimulation (tDCS) has demonstrated preliminary antidepressant effects and beneficial effects on cognitive function.
OBJECTIVE
We investigated the feasibility and acceptability of using tDCS to enhance the effects of computer-based CBT for treatment of MDD.
MATERIALS AND METHODS
In a randomized, double-blind, sham-controlled study, 14 patients with MDD on stable or no pharmacotherapy received active or sham bifrontal tDCS for four weeks with concurrent CBT.
RESULTS
Ten participants completed the protocol. Three withdrew from the study because of lack of efficacy or dislike of the eCBT program. One was discontinued from the protocol by the investigators. Treatment was well tolerated, and most side-effects were mild and consistent with prior tDCS research. Pooled data from both groups showed significant baseline to endpoint improvement in depression (p = 0.008). Overall percent change on the HAMD-21 was 28.98%. The study was underpowered to detect differences in tDCS treatment groups.
CONCLUSIONS
Combining tDCS with computer-based CBT is feasible for MDD. Further work is needed to evaluate potential synergistic effects of combined tDCS and CBT.",2019,Pooled data from both groups showed significant baseline to endpoint improvement in depression (p = 0.008).,"['major depressive disorder (MDD', '14 patients with MDD on stable or no']","['pharmacotherapy received active or sham bifrontal tDCS', 'Computerized Cognitive-Behavioral Therapy Combined With Bifrontal Transcranial Direct Current Stimulation', 'computer-based CBT', 'Transcranial Direct Current Stimulation (tDCS', 'Cognitive behavioral therapy (CBT', 'tDCS']",['depression'],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0445448', 'cui_str': 'Bifrontal (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",14.0,0.0694007,Pooled data from both groups showed significant baseline to endpoint improvement in depression (p = 0.008).,"[{'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'Welch', 'Affiliation': 'Mood Disorders Research Program, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Weigand', 'Affiliation': 'Department of Neurology, Berenson-Allen Center for Noninvasive Brain Stimulation, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Hooker', 'Affiliation': 'Department of Neurology, Berenson-Allen Center for Noninvasive Brain Stimulation, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, Providence, RI, USA.'}, {'ForeName': 'Audrey R', 'Initials': 'AR', 'LastName': 'Tyrka', 'Affiliation': 'Mood Disorders Research Program, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Daniel Z', 'Initials': 'DZ', 'LastName': 'Press', 'Affiliation': 'Department of Neurology, Berenson-Allen Center for Noninvasive Brain Stimulation, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Carpenter', 'Affiliation': 'Mood Disorders Research Program, Butler Hospital, Providence, RI, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.12807']
1783,28549161,Cigarette Smoking Cessation Intervention for Buprenorphine Treatment Patients.,"Introduction
Patients receiving medication assisted therapy (MAT) for opioid use disorder have high cigarette smoking rates. Cigarette smoking interventions have had limited success. We evaluated an intervention to increase cigarette abstinence rates in patients receiving buprenorphine-assisted therapy.
Methods
Cigarette smokers (N = 175; 78% male; 69% Caucasian; 20% Hispanic), recruited from a buprenorphine clinic were randomly assigned to either an extended innovative system intervention (E-ISI) or to Standard Treatment Control (STC). The E-ISI combined motivational intervention with extended treatment (long-term nicotine replacement therapy , varenicline, and extended cognitive behavioral therapy). STC received written information about quit-lines, medication, and resources. Assessments were held at baseline and 3, 6, 12, and 18 months. Seven-day biochemically verified point-prevalence cigarette abstinence was the primary outcome measure.
Results
Fifty-four percent of E-ISI participants entered the extended treatment intervention; E-ISI and STC differed at 3 months on abstinence status but not at months 6, 12, and 18. E-ISI participants were more likely to attempt to quit, to have a goal of complete abstinence, and to be in a more advanced stage of change than STC participants. A higher number of cigarettes smoked and the use of cannabis in the previous 30 days predicted continued smoking.
Conclusions
The E-ISI was successful in increasing motivation to quit smoking but did not result in long-term abstinence. The failure of treatments that have been efficacious in the general population to produce abstinence in patients receiving MAT of opioid use disorder suggests that harm reduction and other innovative interventions should be explored.
Implications
This study demonstrates that an intervention combining motivational interviewing with an extended treatment protocol can increase cigarette quit attempts, enhance cigarette abstinence goals, and further movement through stages of change about quitting smoking in patients receiving MAT for opioid use disorder who smoke cigarettes. The intervention did not increase abstinence rates over those observed in a standard treatment control, however. The latter finding supports those of earlier investigators who also failed to find efficacy for smoking cessation in this population and who also used interventions effective in the general population. This pattern of findings suggests that patients with opioid use disorder can be motivated to change smoking behavior, but alternative and innovative approaches to cigarette smoking treatment should be studied.",2018,"The failure of treatments that have been efficacious in the general population to produce abstinence in patients receiving MAT of opioid use disorder suggests that harm reduction and other innovative interventions should be explored.
","['Treatment Patients', 'Methods\n\n\nCigarette smokers (N = 175; 78% male; 69% Caucasian; 20% Hispanic), recruited from a buprenorphine clinic', 'patients receiving buprenorphine-assisted therapy', 'patients with opioid use disorder', 'patients receiving MAT for opioid use disorder who smoke cigarettes']","['Cigarette smoking interventions', 'Cigarette Smoking Cessation Intervention', 'Buprenorphine', 'motivational intervention with extended treatment (long-term nicotine replacement therapy , varenicline, and extended cognitive behavioral therapy', 'extended innovative system intervention (E-ISI) or to Standard Treatment Control (STC', 'medication assisted therapy (MAT']","['abstinence rates', 'cigarette quit attempts, enhance cigarette abstinence goals', 'cigarette abstinence rates', 'motivation to quit smoking']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.0230266,"The failure of treatments that have been efficacious in the general population to produce abstinence in patients receiving MAT of opioid use disorder suggests that harm reduction and other innovative interventions should be explored.
","[{'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Humfleet', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gasper', 'Affiliation': 'California Department of Health Care Services, Sacramento, CA.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Hersh', 'Affiliation': 'Desert AIDS Project, Palm Springs, CA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Guydish', 'Affiliation': 'Philip R. Lee institute for Health Policy studies, University of California, San Francisco, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntx113']
1784,31813281,Baseline Characteristics of the VANISH Cohort.,"BACKGROUND
The VANISH trial (Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy) targeted young sarcomeric gene mutation carriers with early-stage hypertrophic cardiomyopathy (HCM) to test whether valsartan can modify disease progression. We describe the baseline characteristics of the VANISH cohort and compare to previous trials evaluating angiotensin receptor blockers.
METHODS
Applying a randomized, double-blinded, placebo-controlled design, 178 participants with nonobstructive HCM (age, 23.3±10.1 years; 61% men) were randomized in the primary cohort and 34 (age, 16.5±4.9 years; 50% men) in the exploratory cohort of sarcomeric mutation carriers without left ventricular hypertrophy.
RESULTS
In the primary cohort, maximal left ventricular wall thickness was 17±4 mm for adults and Z score 7.0±4.5 for children. Nineteen percent had late gadolinium enhancement on cardiac magnetic resonance. Mean peak oxygen consumption was 33 mL/kg per minute, and 92% of participants were New York Heart Association functional class I. New York Heart Association class II was associated with older age, MYH7 variants, and more prominent imaging abnormalities. Six previous trials of angiotensin receptor blockers in HCM enrolled a median of 24 patients (range, 19-133) with mean age of 51.2 years; 42% of patients were in New York Heart Association class ≥II, and sarcomeric mutations were not required.
CONCLUSIONS
The VANISH cohort is much larger, younger, less heterogeneous, and has less advanced disease than prior angiotensin receptor blocker trials in HCM. Participants had relatively normal functional capacity and mild HCM features. New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and MYH7 variants, suggesting both phenotype and genotype contribute to disease manifestations.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01912534.",2019,"New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and MYH7 variants, suggesting both phenotype and genotype contribute to disease manifestations.
","['HCM enrolled a median of 24 patients (range, 19-133) with mean age of 51.2 years; 42% of patients were in New York Heart Association class ≥II, and sarcomeric mutations were not required', '178 participants with nonobstructive HCM (age, 23.3±10.1 years; 61% men) were randomized in the primary cohort and 34 (age, 16.5±4.9 years; 50% men) in the exploratory cohort of sarcomeric mutation carriers without left ventricular hypertrophy']","['placebo', 'valsartan', 'angiotensin receptor blockers', 'VANISH trial (Valsartan']","['maximal left ventricular wall thickness', 'late gadolinium enhancement on cardiac magnetic resonance', 'normal functional capacity and mild HCM features', 'Mean peak oxygen consumption']","[{'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0340425', 'cui_str': 'Hypertrophic cardiomyopathy without obstruction'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",178.0,0.398618,"New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and MYH7 variants, suggesting both phenotype and genotype contribute to disease manifestations.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Axelsson Raja', 'Affiliation': 'Copenhagen University Hospital Rigshospitalet, Denmark (A.A.R., H.B.).'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'New England Research Institutes, Watertown, MA (L.S.).'}, {'ForeName': 'Sharlene M', 'Initials': 'SM', 'LastName': 'Day', 'Affiliation': 'University of Michigan, Ann Arbor (S.M.D., M.R.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'University of Michigan, Ann Arbor (S.M.D., M.R.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Zahka', 'Affiliation': 'Cleveland Clinic, OH (K.Z., H.L.).'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Lever', 'Affiliation': 'Cleveland Clinic, OH (K.Z., H.L.).'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Colan', 'Affiliation': ""Boston Children's Hospital, MA (S.D.C., R.M.).""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Margossian', 'Affiliation': ""Boston Children's Hospital, MA (S.D.C., R.M.).""}, {'ForeName': 'E Kevin', 'Initials': 'EK', 'LastName': 'Hall', 'Affiliation': 'Yale University, New Haven, CT (E.K.H.).'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN (J.B.).'}, {'ForeName': 'John Lynn', 'Initials': 'JL', 'LastName': 'Jefferies', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, OH (J.L.J.).""}, {'ForeName': 'Amit R', 'Initials': 'AR', 'LastName': 'Patel', 'Affiliation': 'University of Chicago, IL (A.R.P.).'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Choudhury', 'Affiliation': 'Northwestern University, Chicago, IL (L.C.).'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murphy', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD (A.M.M.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Canter', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO (C.C., R.B.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bach', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO (C.C., R.B.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora (M.T., L.M.).'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Mestroni', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora (M.T., L.M.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wheeler', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA (M.T.W.).'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Benson', 'Affiliation': 'Toronto Hospital for Sick Children, ON, Canada (L.B.).'}, {'ForeName': 'Anjali T', 'Initials': 'AT', 'LastName': 'Owens', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia (A.T.O.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rossano', 'Affiliation': ""Children's Hospital of Philadelphia, PA (J.R., K.Y.L.).""}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Lin', 'Affiliation': ""Children's Hospital of Philadelphia, PA (J.R., K.Y.L.).""}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, IL (E.P.).""}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Pereira', 'Affiliation': 'Heart Institute, University of São Paulo Medical School (Instituto do Coração), Brazil (A.C.P.).'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'Copenhagen University Hospital Rigshospitalet, Denmark (A.A.R., H.B.).'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts General Hospital, Boston (G.D.L.).'}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Vargas', 'Affiliation': 'MedStar Georgetown University Hospital, National Institutes of Health, Bethesda, MD (J.D.V.).'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Cirino', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, UK (J.J.V.M.).'}, {'ForeName': 'Calum A', 'Initials': 'CA', 'LastName': 'MacRae', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).""}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006231']
1785,31581789,Impact of Procedural Bleeding in Peripheral Artery Disease: An Analysis From EUCLID Trial.,"BACKGROUND
The relationship between invasive vascular procedures and bleeding in patients with peripheral artery disease has not been well described in the literature. This post hoc analysis from the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) aimed to describe the incidence of major and minor postprocedural bleeding and characterize the timing and severity of bleeding events relative to the procedure.
METHODS
EUCLID was a multicenter, randomized controlled trial of 13 885 patients with symptomatic peripheral artery disease that tested the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events. A total of 2661 patients underwent 3062 coronary revascularization, peripheral revascularization, and amputation during the study. The primary safety end point was Thrombolysis in Myocardial Infarction major or minor bleeding. All bleeding events were formally adjudicated by a clinical end point classification group.
RESULTS
Major bleeding events most often occurred ≤7 days following the procedure. The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%). The severity of bleeding events (as graded by drop in hemoglobin, need for transfusion, bleeding in a critical location, and fatal bleeding) was also similar following peripheral, coronary revascularization, and lower extremity amputation.
CONCLUSIONS
The incidence of Thrombolysis in Myocardial Infarction major/minor bleeding following peripheral revascularization is comparable to rates after coronary revascularization and lower extremity amputation, and the majority of bleeding events occur within 7 days following the procedure. The severity of periprocedural bleeding is also similar after procedures, with the most frequently adjudicated reason being a drop in hemoglobin ≥2 g/dL. Future studies should be performed to enhance our understanding of bleeding risk related to revascularization and amputation procedures in peripheral artery disease patients.",2019,"The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%).","['peripheral artery disease patients', '2661 patients underwent 3062 coronary revascularization, peripheral revascularization, and amputation during the study', '13\u2009885 patients with symptomatic peripheral artery disease', 'patients with peripheral artery disease', 'for the prevention of major adverse cardiovascular events', 'Peripheral Artery Disease']","['Ticagrelor', 'ticagrelor', 'clopidogrel']","['lower extremity amputation', 'hemoglobin, need for transfusion, bleeding in a critical location, and fatal bleeding', 'severity of bleeding events', 'Myocardial Infarction major or minor bleeding', 'All bleeding events', 'severity of periprocedural bleeding', 'incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization']","[{'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C3160770', 'cui_str': 'Minor bleed'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}]",2661.0,0.0398607,"The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%).","[{'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Kansal', 'Affiliation': 'Division of Cardiology, Duke Heart Center (A.K., M.R.P., S.J.), Duke University, Durham, NC.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine (Z.H., F.W.R., M.R.P., W.S.J.), Duke University, Durham, NC.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine (Z.H., F.W.R., M.R.P., W.S.J.), Duke University, Durham, NC.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Cardiovascular Centre, Inselspital, Bern University Hospital, University of Bern, Switzerland (I.B.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Departments of Medicine and Surgery, New York University School of Medicine (J.S.B.).'}, {'ForeName': 'Juuso I', 'Initials': 'JI', 'LastName': 'Blomster', 'Affiliation': 'Turku University Hospital, Turku University, Finland (J.I.B.).'}, {'ForeName': 'F Gerry', 'Initials': 'FG', 'LastName': 'Fowkes', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, United Kingdom (F.G.F.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Gaithersburg, MD (B.K.).'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Norgren', 'Affiliation': 'Faculty of Medicine and Health, Örebro University, Sweden (L.N.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'University of Colorado School of Medicine, Division of Cardiology and CPC Clinical Research, Aurora (W.R.H.).'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Duke Heart Center (A.K., M.R.P., S.J.), Duke University, Durham, NC.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Division of Cardiology, Duke Heart Center (A.K., M.R.P., S.J.), Duke University, Durham, NC.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008069']
1786,31583943,Neutropenic complications in the PANTHER phase III study of adjuvant tailored dose-dense chemotherapy in early breast cancer.,"Introduction: Myelosuppresion is a common side effect of chemotherapy and granulocyte-colony stimulating factor (G-CSF) is often used to reduce the risk of neutropenic events. The purpose of this exploratory analysis was to investigate neutropenic complications in the phase III PANTHER trial of standard 3-weekly chemotherapy with 5-fluorouracil, epirubicin and cyclophosphamide plus docetaxel (FEC/D) versus bi-weekly tailored dose-dense EC/D adjuvant chemotherapy in breast cancer. Patients and methods: Febrile neutropenia, neutropenic infection and infection grade 3-4 according to CTC AE 3.0, were explored in relation to G-CSF use. Per cycle analysis was performed concerning dose reduction and dose delays in conjunction with G-CSF administration. Results: In the experimental group, 98.9% of patients received primary G-CSF support during EC and 97.4% during docetaxel, compared with 49.7% during FEC and 63.88% during docetaxel in the standard group. Overall, the use of G-CSF was associated with a lower risk for developing neutropenic events (OR 0.44, 95% CI 0.35-0.55, p < .001). Chemotherapy delays due to neutropenia and leukopenia were significantly decreased among patients that received G-CSF (OR 0.098, 95% CI 0.06-0.15 and OR 0.32, 95% CI 0.18-0.58, respectively). Discussion: In conclusion, G-CSF support reduces neutropenic events and permits increased relative dose intensity, which is essential for improved survival outcomes.",2020,"Chemotherapy delays due to neutropenia and leukopenia were significantly decreased among patients that received G-CSF (OR 0.098, 95% CI 0.06-0.15 and OR 0.32, 95% CI 0.18-0.58, respectively). ","['breast cancer', 'early breast cancer']","['docetaxel', 'G-CSF', '5-fluorouracil, epirubicin and cyclophosphamide plus docetaxel (FEC/D) versus bi-weekly tailored dose-dense EC/D adjuvant chemotherapy', 'chemotherapy and granulocyte-colony stimulating factor (G-CSF', 'adjuvant tailored dose-dense chemotherapy']","['Febrile neutropenia, neutropenic infection and infection grade', 'Neutropenic complications', 'neutropenic complications', 'neutropenic events', 'survival outcomes', 'neutropenia and leukopenia']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C1167779', 'cui_str': 'Neutropenic infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",,0.086549,"Chemotherapy delays due to neutropenia and leukopenia were significantly decreased among patients that received G-CSF (OR 0.098, 95% CI 0.06-0.15 and OR 0.32, 95% CI 0.18-0.58, respectively). ","[{'ForeName': 'Antroula', 'Initials': 'A', 'LastName': 'Papakonstantinou', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Hedayati', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'CKC, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Hemming', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'CKC, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Steger', 'Affiliation': 'Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Obstetrics and Gynecology, Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Moebus', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum Frankfurt Höchst, Academic Hospital of the Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Foukakis', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Matikas', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2019.1670353']
1787,28351203,Effects of varenicline on alcohol self-administration and craving in drinkers with depressive symptoms.,"Varenicline (VAR) is approved to aid in smoking cessation and has been shown to be effective for reducing alcohol consumption in heavy drinkers. Little is known, however, about treatment moderators that may influence efficacy. The current study reanalyzed data from a human laboratory study (Verplaetse et al., 2016) to determine whether VAR was more effective at reducing alcohol use among drinkers reporting symptoms of depression. Participants were 60 adults meeting DSM-IV criteria for alcohol use disorders ( n = 60) who were randomly assigned to receive VAR (1 mg/day, 2 mg/day) or placebo. Following 7 days of medication pretreatment, participants attended a laboratory testing session. They provided self-reported ratings of alcohol craving and performed an ad libitum alcohol consumption task after receiving a priming dose of alcohol (target blood alcohol concentration = 0.030 g/dL). Higher blood VAR plasma levels were associated with less alcohol craving and less drinking among participants with more depressive symptoms. Among participants with fewer depressive symptoms, VAR was associated with more drinking during the ad libitum drinking task. These findings show that depression symptoms may be a moderator of VAR efficacy in alcohol users and provides evidence for the role of nAChRs in depression and alcohol use.",2017,Higher blood VAR plasma levels were associated with less alcohol craving and less drinking among participants with more depressive symptoms.,"['drinkers with depressive symptoms', 'Participants were 60 adults meeting DSM-IV criteria for alcohol use disorders ( n = 60', 'heavy drinkers']","['VAR', 'varenicline', 'Varenicline (VAR', 'placebo']","['Higher blood VAR plasma levels', 'alcohol self-administration and craving']","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0036589', 'cui_str': 'Self Administration'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",60.0,0.0375426,Higher blood VAR plasma levels were associated with less alcohol craving and less drinking among participants with more depressive symptoms.,"[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Roberts', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, New Haven, CT, USA.'}, {'ForeName': 'Terril L', 'Initials': 'TL', 'LastName': 'Verplaetse', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, New Haven, CT, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, New Haven, CT, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Oberleitner', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, New Haven, CT, USA.'}, {'ForeName': 'Marina R', 'Initials': 'MR', 'LastName': 'Picciotto', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, New Haven, CT, USA.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'McKee', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, New Haven, CT, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881117699618']
1788,28655025,Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial.,"Importance
Buprenorphine is an efficacious, widely used treatment for opioid use disorder (OUD). Daily oral transmucosal formulations can be associated with misuse, diversion, and nonadherence; these limitations may be obviated by a sustained release formulation.
Objective
To evaluate the ability of a novel, weekly, subcutaneous buprenorphine depot formulation, CAM2038, to block euphorigenic opioid effects and suppress opioid withdrawal in non-treatment-seeking individuals with OUD.
Design, Setting, and Participants
This multisite, double-blind, randomized within-patient study was conducted at 3 controlled inpatient research facilities. It involved 47 adults with DSM-V moderate-to-severe OUD. The study was conducted from October 12, 2015 (first patient enrolled), to April 21, 2016 (last patient visit).
Interventions
A total of five 3-day test sessions evaluated the response to hydromorphone (0, 6, and 18 mg intramuscular in random order; 1 dose/session/day). After the first 3-day session (ie, qualification phase), participants were randomized to either CAM2038 weekly at 24 mg (n = 22) or 32 mg (n = 25); the assigned CAM2038 dose was given twice, 1 week apart (day 0 and 7). Four sets of sessions were conducted after randomization (days 1-3, 4-6, 8-10, and 11-13).
Main Outcomes and Measures
The primary end point was maximum rating on the visual analog scale for drug liking. Secondary end points included other visual analog scale (eg, high and desire to use), opioid withdrawal scales, and physiological and pharmacokinetic outcomes.
Results
A total of 46 of 47 randomized participants (mean [SD] age, 35.5 [9] years; 76% male [n = 35]) completed the study. Both weekly CAM2038 doses produced immediate and sustained blockade of hydromorphone effects (liking maximum effect, CAM2038, 24 mg: effect size, 0.813; P < .001, and CAM2038, 32 mg: effect size, 0.753; P < .001) and suppression of withdrawal (Clinical Opiate Withdrawal Scale, CAM2038, 24 mg: effect size, 0.617; P < .001, and CAM2038, 32 mg: effect size, 0.751; P < .001). CAM2038 produces a rapid initial rise of buprenorphine in plasma with maximum concentration around 24 hours, with an apparent half-life of 4 to 5 days and approximately 50% accumulation of trough concentration from first to second dose (trough concentration = 0.822 and 1.23 ng/mL for weeks 1 and 2, respectively, with 24 mg; trough concentration = 0.993 and 1.47 ng/mL for weeks 1 and 2, respectively, with 32 mg).
Conclusions and Relevance
CAM2038 weekly, 24 and 32 mg, was safely tolerated and produced immediate and sustained opioid blockade and withdrawal suppression. The results support the use of this depot formulation for treatment initiation and stabilization of patients with OUD, with the further benefit of obviating the risk for misuse and diversion of daily buprenorphine while retaining its therapeutic benefits.
Trial Registration
Clinicaltrials.gov Identifier: NCT02611752.",2017,"Both weekly CAM2038 doses produced immediate and sustained blockade of hydromorphone effects (liking maximum effect, CAM2038, 24 mg: effect size, 0.813; P < .001, and CAM2038, 32 mg: effect size, 0.753; P < .001) and suppression of withdrawal (Clinical Opiate Withdrawal Scale, CAM2038, 24 mg: effect size, 0.617; P < .001, and CAM2038, 32 mg: effect size, 0.751; P < .001).","['Individuals With Opioid Use Disorder', 'October 12, 2015 (first patient enrolled), to April 21, 2016 (last patient visit', '47 adults with DSM-V moderate-to-severe OUD', 'patients with OUD', 'A total of 46 of 47 randomized participants (mean [SD] age, 35.5 [9] years; 76% male [n\u2009=\u200935]) completed the study', 'non-treatment-seeking individuals with OUD']","['buprenorphine depot formulation, CAM2038', 'Hydromorphone Blockade', 'Buprenorphine Weekly Depot (CAM2038', 'buprenorphine', 'Buprenorphine', 'CAM2038', 'hydromorphone']","['maximum rating on the visual analog scale for drug liking', 'visual analog scale (eg, high and desire to use), opioid withdrawal scales, and physiological and pharmacokinetic outcomes', 'suppression of withdrawal (Clinical Opiate Withdrawal Scale', 'safely tolerated and produced immediate and sustained opioid blockade and withdrawal suppression']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}, {'cui': 'C0222045'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C3472219', 'cui_str': 'Clinical opiate withdrawal scale (assessment scale)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",47.0,0.150295,"Both weekly CAM2038 doses produced immediate and sustained blockade of hydromorphone effects (liking maximum effect, CAM2038, 24 mg: effect size, 0.813; P < .001, and CAM2038, 32 mg: effect size, 0.753; P < .001) and suppression of withdrawal (Clinical Opiate Withdrawal Scale, CAM2038, 24 mg: effect size, 0.617; P < .001, and CAM2038, 32 mg: effect size, 0.751; P < .001).","[{'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'Center on Drug and Alcohol Research, University of Kentucky, Lexington.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Lofwall', 'Affiliation': 'Center on Drug and Alcohol Research, University of Kentucky, Lexington.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Vince and Associates Clinical Research, Overland Park, Kansas.'}, {'ForeName': 'Naama', 'Initials': 'N', 'LastName': 'Levy-Cooperman', 'Affiliation': 'Altreos Partners, Toronto, Ontario, Canada.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kelsh', 'Affiliation': 'Vince and Associates Clinical Research, Overland Park, Kansas.'}, {'ForeName': 'Marion A', 'Initials': 'MA', 'LastName': 'Coe', 'Affiliation': 'Center on Drug and Alcohol Research, University of Kentucky, Lexington.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Nuzzo', 'Affiliation': 'Center on Drug and Alcohol Research, University of Kentucky, Lexington.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Tiberg', 'Affiliation': 'Camurus, Lund, Sweden.'}, {'ForeName': 'Behshad', 'Initials': 'B', 'LastName': 'Sheldon', 'Affiliation': 'Braeburn Pharmaceuticals, Princeton, New Jersey.'}, {'ForeName': 'Sonnie', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Braeburn Pharmaceuticals, Princeton, New Jersey.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2017.1874']
1789,29608807,Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study.,"OBJECTIVE
Different approaches in neuromodulation have been used to treat chronic low back pain in failed back surgery syndrome (FBSS) patients. We previously randomized 52 FBSS patients to be treated with spinal cord stimulation (SCS) and additional peripheral nerve field stimulation (PNFS) or SCS alone. At three months, we found a significant reduction of back pain in the PNFS-SCS group compared to the SCS group. In the subsequent open phase part of the study, all patients received optimal SCS and PNFS simultaneously. Here, we present the 12-month follow-up data on back and leg pain.
MATERIALS AND METHODS
Data regarding back and leg pain, function, quality of life, patient satisfaction, anxiety and depression, and use of medication were collected by analyzing patients' questionnaires at 12 months and compared with data collected at baseline. Data were analyzed using multilevel regression models.
RESULTS
A combined group of 50 subjects completed the 12-month follow-up. Back pain, measured on a 100-mm visual analog scale (VAS), significantly decreased over this period by 30.0 mm (95% CI: [-37.7/-22.4]; p < 0.001), while leg pain decreased by 43.7 mm (95% CI: [-51.5/-36.2]; p < 0.001). We observed statistically significant improvement in almost all secondary outcome measurements.
CONCLUSIONS
At 12-month follow-up, PNFS in addition to SCS continues to provide a statistically significant and clinically relevant relief of low back pain in FBSS patients in whom SCS alone is effective for relief of leg pain only.",2019,"At three months, we found a significant reduction of back pain in the PNFS-SCS group compared to the SCS group.","['Failed Back Surgery Syndrome Patients', 'failed back surgery syndrome (FBSS) patients']","['Peripheral Nerve Field Stimulation', 'spinal cord stimulation (SCS) and additional peripheral nerve field stimulation (PNFS) or SCS alone', 'Spinal Cord Stimulation', 'SCS']","['back pain', 'Back pain', 'leg pain', 'back and leg pain, function, quality of life, patient satisfaction, anxiety and depression, and use of medication', '100-mm visual analog scale (VAS']","[{'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",52.0,0.121733,"At three months, we found a significant reduction of back pain in the PNFS-SCS group compared to the SCS group.","[{'ForeName': 'Eric-Jan J A A', 'Initials': 'EJAA', 'LastName': 'van Gorp', 'Affiliation': 'Department of Anesthesiology, Unit of Pain Medicine, Albert Schweitzer Hospital, Sliedrecht, The Netherlands.'}, {'ForeName': 'Onno', 'Initials': 'O', 'LastName': 'Teernstra', 'Affiliation': 'Department of Neurosurgery, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Aukes', 'Affiliation': 'Department of Anesthesiology, Unit of Pain Medicine, Albert Schweitzer Hospital, Sliedrecht, The Netherlands.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Hamm-Faber', 'Affiliation': 'Department of Anesthesiology, Unit of Pain Medicine, Albert Schweitzer Hospital, Sliedrecht, The Netherlands.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bürger', 'Affiliation': 'Department of Anesthesiology, Rijnland Hospital, Leiderdorp, The Netherlands.'}, {'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'Kallewaard', 'Affiliation': 'Department of Anesthesiology, Rijnstate Hospital, Velp, The Netherlands.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Spincemaille', 'Affiliation': 'Department of Neurosurgery, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Johannes W L C', 'Initials': 'JWLC', 'LastName': 'Schapendonk', 'Affiliation': 'Department of Anesthesiology, Diakonessenhuis, Zeist, The Netherlands.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Vonhögen', 'Affiliation': 'Department of Anesthesiology, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'Ewald', 'Initials': 'E', 'LastName': 'Bronkhorst', 'Affiliation': 'Department of Cariology and Preventive Dentistry, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Kris C P', 'Initials': 'KCP', 'LastName': 'Vissers', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Palliative Care, Radboud University Medical Centre, Nijmegen, The Netherlands.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.12776']
1790,31735564,The effect of maternal voice for procedural pain in paediatric intensive care unit: A randomised controlled trial.,"OBJECTIVE
The aim of this study was to evaluate the effectiveness of the maternal voice in reducing pain during painful procedures in children between one and three years old receiving treatment in paediatric intensive care unit.
DESIGN AND METHODS
This research was designed as a randomised controlled experimental study. Sixty children were randomised into two groups, the maternal-voice group and the controls. The children in the maternal-voice group listened to the maternal voice during the procedure. Although questionnaire forms were used to determine the descriptive characteristics of infants, the Face, Legs, Activity, Cry, Consolability (FLACC) pain assessment scale was used to evaluate pain level. Heart rate and oxygen saturation were also measured.
RESULTS
There were significant differences in the pain, heart rate and oxygen saturation levels between the maternal-voice and control groups. Pain levels and heart rates of the children in the experimental group during and after the painful procedures were much lower, and their oxygen saturations were higher than those of the children in the control group.
PRACTIC IMPLICATIONS
Distraction methods, such as listening to the maternal voice, should be used as a nursing intervention to reduce pain and decrease heart rate and increaseoxygen saturation in children during painful procedures in the paediatric intensive care unit. The maternal voice is recommended as a helpful option in cases when a pain control method is required. Future research needs to explore different interventional practices.",2020,"Pain levels and heart rates of the children in the experimental group during and after the painful procedures were much lower, and their oxygen saturations were higher than those of the children in the control group.
","['Sixty children', 'children during painful procedures in the paediatric intensive care unit', 'children between one and three years old receiving treatment in paediatric intensive care unit', 'pediatric intensive care unit']",['maternal voice'],"['Face, Legs, Activity, Cry, Consolability (FLACC) pain assessment scale', 'pain, heart rate and oxygen saturation levels', 'pain', 'Heart rate and oxygen saturation', 'Pain levels and heart rates', 'oxygen saturations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",60.0,0.0512997,"Pain levels and heart rates of the children in the experimental group during and after the painful procedures were much lower, and their oxygen saturations were higher than those of the children in the control group.
","[{'ForeName': 'Çiğdem', 'Initials': 'Ç', 'LastName': 'Erdoğan', 'Affiliation': 'Faculty of Health Science, Pediatric Nursing Department, Pamukkale University, Denizli, Turkey. Electronic address: cigdemg@pau.edu.tr.'}, {'ForeName': 'Türkan', 'Initials': 'T', 'LastName': 'Turan', 'Affiliation': 'Faculty of Health Science, Pediatric Nursing Department, Pamukkale University, Denizli, Turkey. Electronic address: turkanturan@pau.edu.tr.'}, {'ForeName': 'Bakiye', 'Initials': 'B', 'LastName': 'Pınar', 'Affiliation': 'Pamukkale University Hospital, Pediatric Intensive Care Unit, Pamukkale University, Denizli, Turkey.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2019.102767']
1791,31120108,"Forced diuresis with matched hydration during transcatheter aortic valve implantation for Reducing Acute Kidney Injury: a randomized, sham-controlled study (REDUCE-AKI).","AIMS
Acute kidney injury (AKI) is a common complication following transcatheter aortic valve implantation (TAVI) and is associated with increased risk for short- and long-term mortality. In patients undergoing percutaneous coronary intervention (PCI), forced diuresis with matched hydration has been shown to reduce the incidence of AKI by ∼50%. The aim of the present study was to evaluate whether forced diuresis with matched intravenous hydration reduces AKI in patients undergoing TAVI.
METHODS AND RESULTS
Reducing Acute Kidney Injury (REDUCE-AKI) was a single-centre, prospective, randomized, double-blind sham-controlled clinical trial, designed to examine the effect of an automated matched saline infusion with urine output for the prevention of AKI in patients undergoing TAVI. A total of 136 TAVI patients were randomized, 68 in each group. Mean age was 83.9 ± 5 years and 41.2% were males. There were no differences in baseline characteristics between the two groups. The rate of AKI was not statistically different between the groups (25% in the active group vs. 19.1% in the sham group, P = 0.408). There was a significant increase in long-term mortality in the active group (27.9% vs. 13. 2% HR 3.744, 95% CI 1.51-9.28; P = 0.004). The study was terminated prematurely by the Data Safety Monitoring Board for futility and a possible signal of harm.
CONCLUSIONS
Unlike in PCI, forced diuresis with matched hydration does not prevent AKI in patients undergoing TAVI, and might be associated with increased long-term mortality. Future studies should focus on understanding the mechanisms behind these findings.
CLINICALTRIALS.GOV REGISTRATION
NCT01866800, 30 April 2013.",2019,"The rate of AKI was not statistically different between the groups (25% in the active group vs. 19.1% in the sham group, P = 0.408).","['patients undergoing TAVI', 'Mean age was 83.9\u2009±\u20095\u2009years and 41.2% were males', '136 TAVI patients', 'Acute Kidney Injury', 'patients undergoing percutaneous coronary intervention (PCI']","['Forced diuresis with matched hydration during transcatheter aortic valve implantation', 'saline infusion with urine output', 'transcatheter aortic valve implantation (TAVI']","['long-term mortality', 'rate of AKI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0554808', 'cui_str': 'Forced diuresis (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",136.0,0.534294,"The rate of AKI was not statistically different between the groups (25% in the active group vs. 19.1% in the sham group, P = 0.408).","[{'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Arbel', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Ben-Assa', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Puzhevsky', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Batia', 'Initials': 'B', 'LastName': 'Litmanowicz', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Naama', 'Initials': 'N', 'LastName': 'Galli', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Chorin', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Halkin', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Sadeh', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Konigstein', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Orit Kliuk-Ben', 'Initials': 'OK', 'LastName': 'Bassat', 'Affiliation': 'Department of Nephrology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Steinvil', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bazan', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Banai', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.'}]",European heart journal,['10.1093/eurheartj/ehz343']
1792,32413673,The effects of testosterone on the physiological response to social and somatic stressors.,"Higher testosterone levels in males have previously been linked to decreased stress reactivity, but in other cases, testosterone has been reported to increase the stress response. We addressed these inconsistencies in a placebo-controlled single-dose testosterone administration study, in which 120 male participants were randomly assigned to undergo a cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition). Throughout the experiment, blood pressure and interbeat intervals were measured continuously, and saliva samples for hormonal analyses were taken repeatedly at predefined time points. When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies. However, testosterone administration altered this pattern. Compared to placebo, testosterone increased systolic blood pressure during the CPT, whereas the opposite effect was found during the SECPT. Cortisol reactivity was not affected by testosterone administration. The CAG repeat polymorphism of the androgen receptor gene was unrelated to the effects of testosterone on the stress response, but it was correlated with blood pressure across the whole sample. Our findings demonstrate that testosterone's effects on the stress response are dependent on the social context. Testosterone's ability to flexibly influence the response to stressors may be an important mechanism through which the hormone promotes adaptive behavior. Our results are also in line with research showing that testosterone decreases social anxiety and suggest it may help to modulate the effects of stress in socially challenging situations.",2020,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.",['120 male participants'],"['SECPT', 'placebo, testosterone', 'testosterone', 'placebo-controlled single-dose testosterone', 'Testosterone', 'cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition', 'placebo']","['blood pressure', 'blood pressure and interbeat intervals', 'systolic blood pressure', 'social anxiety', 'Cortisol reactivity']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",120.0,0.036,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.","[{'ForeName': 'Hana H', 'Initials': 'HH', 'LastName': 'Kutlikova', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: hana.kutlikova@univie.ac.at.'}, {'ForeName': 'Jaroslava Babková', 'Initials': 'JB', 'LastName': 'Durdiaková', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, Comenius University in Bratislava, Sasinkova 2, 813 72 Bratislava, Slovakia. Electronic address: durdiakova.jaroslava@fmed.uniba.sk.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Institute of Biomedical Science, FH Joanneum University of Applied Sciences, Eggenberger Allee 13, 8020 Graz, Austria. Electronic address: bernhard.wagner@fh-joanneum.at.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Vlček', 'Affiliation': 'Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Dúbravská cesta 9, 845 05 Bratislava, Slovakia. Electronic address: miroslav.vlcek@savba.sk.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Riečanský', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Department of Behavioural Neuroscience, Institute of Normal and Pathological Physiology, Centre of Experimental Medicine, Slovak Academy of Sciences, Sienkiewiczova 1, 813 71 Bratislava, Slovakia. Electronic address: igor.riecansky@savba.sk.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104693']
1793,32413812,Effects of a mindfulness based behavioral intervention for young adults with childhood maltreatment history on hippocampal morphometry: a pilot MRI study with voxel-based morphometry.,"Childhood maltreatment has long lasting impacts on neural development of the hippocampus, which is important for learning and memory. The present study aimed to assess the effects of a mindfulness based intervention on hippocampal morphometry and episodic memory in this population. We administered MRI, psychological questionnaires and an episodic memory task to 21 participants (5 males) before and after a mindfulness-based behavioral intervention, compared to 21 participants (7 males) on the waiting list. Changes in Gray Matter Volume (GMV) in bilateral hippocampi were analyzed with Voxel-Based Morphometry (VBM). One cluster was identified in the right hippocampus with a group by time interaction effect that consisted of 130 contiguous voxels but fell short of significance with full FDR correction (p = 0.077). GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group. Within the mindfulness group, changes in hippocampal GMV were negatively associated with changes in perceived stress and depression severity and positively associated with enhancement in performance accuracy on the episodic memory task. Findings from this pilot study suggest that a mindfulness-based intervention may lead to an increase in partial hippocampal GMV with associated symptom reduction and improvement in episodic memory.",2020,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"['21 participants (5 males) before and after a', 'young adults with childhood maltreatment history on hippocampal morphometry']","['mindfulness based intervention', 'mindfulness-based behavioral intervention', 'mindfulness based behavioral intervention']","['perceived stress and depression severity', 'GMV', 'hippocampal morphometry and episodic memory', 'episodic memory', 'hippocampal GMV', 'partial hippocampal GMV', 'Gray Matter Volume (GMV']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",130.0,0.0170544,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Joss', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA. Electronic address: djoss@mclean.harvard.edu.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Teicher', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111087']
1794,31494306,Early and late effects of remote ischemic preconditioning on spirometry and gas exchange in healthy volunteers.,"PURPOSE
Remote ischemic preconditioning (RIP) may protect remote organs from ischemia-reperfusion-injury (IRI) in surgical and non-surgical patients. There are few data available on RIP and lung function, especially not in healthy volunteers. The null-hypothesis was tested that RIP does not have an effect on pulmonary function when applied on healthy volunteers that were breathing spontaneously and did not experience any intervention. After approval of the Ethics Committee and informed consent of the study subjects, 28 healthy non-smoking volunteers were included and randomized in either the RIP group (n = 13) or the control group (n = 15). In the RIP group, lower limb ischemia was induced by inflation of a blood pressure cuff to a pressure 20 mmHg above the systolic blood pressure. After five minutes the blood pressure cuff was released for five minutes rest. The procedure was repeated three times resulting in 40 min ischemia and reperfusion. Capillary blood samples were taken, and lung function tests were performed at baseline (T1) and 60 min (T2) and 24 h (T3) after RIP. The control group was treated in the same fashion, but the RIP procedure was replaced by a sham protocol.
RESULTS
60 min after RIP capillary pO 2 decreased significantly and returned to baseline level after 24 h in the RIP group. This did not occur in the control group. Capillary pCO 2 , variables of lung function tests and pulmonary capillary blood volume remained unchanged throughout the experiment in both groups.
CONCLUSION
Oxygenation is impaired early after RIP which is possibly induced by transient ventilation-perfusion inequality. No late effects of RIP were observed. The null hypothesis has to be rejected that RIP has no effect on respiratory variables in healthy volunteers.",2020,"Capillary pCO 2 , variables of lung function tests and pulmonary capillary blood volume remained unchanged throughout the experiment in both groups.
","['28 healthy non-smoking volunteers', 'healthy volunteers']","['remote ischemic preconditioning', 'Remote ischemic preconditioning (RIP']","['Capillary pCO 2 , variables of lung function tests and pulmonary capillary blood volume', 'blood pressure cuff', 'systolic blood pressure', 'lower limb ischemia']","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}]","[{'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0429754', 'cui_str': 'Pulmonary capillary blood volume (observable entity)'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff, device (physical object)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0340565', 'cui_str': 'Lower limb ischemia (disorder)'}]",28.0,0.0152395,"Capillary pCO 2 , variables of lung function tests and pulmonary capillary blood volume remained unchanged throughout the experiment in both groups.
","[{'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'Senior Consultant in Cardiothoracic Anesthesia, Department of Anesthesiology and Intensive Care Medicine, Otto-von-Guericke-University Magdeburg, Germany, and Research Anesthesiologist, Department of Surgical Sciences, Hedenstierna Laboratory, Uppsala University, Sweden. Electronic address: Astrid.Bergmann@med.ovgu.de.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jovanovska', 'Affiliation': 'Consultant in Anesthesiology, Department of Anesthesiology and Intensive Care Medicine, Otto-von-Guericke-University Magdeburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schilling', 'Affiliation': 'Professor of Anesthesia, Department of Anesthesiology and Intensive Care Medicine, Otto-von-Guericke-University, Magdeburg, Germany.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Hedenstierna', 'Affiliation': 'Senior Professor in Clinical Physiology, Hedenstierna Laboratory, Department of Medical Sciences, Clinical Physiology, Uppsala University, Sweden.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Föllner', 'Affiliation': 'Senior Consultant, Department of Pulmonology, Otto-von-Guericke-University, Magdeburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Schreiber', 'Affiliation': 'Professor of Pulmonology, Department of Pulmonology, Otto-von-Guericke-University, Magdeburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hachenberg', 'Affiliation': 'Professor of Anesthesia and Chair of the Department of Anesthesiology and Intensive Care Medicine, Otto-von-Guericke-University, Magdeburg, Germany.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2019.103287']
1795,30142427,Beneficial effects of lifestyle intervention in non-obese patients with non-alcoholic fatty liver disease.,"BACKGROUND & AIMS
Around 10-20% of patients with non-alcoholic fatty liver disease (NAFLD) are non-obese. The benefit of weight reduction in such patients is unclear. We aim to study the efficacy of lifestyle intervention in non-obese patients with NAFLD and to identify factors that predict treatment response.
METHODS
A total of 154 community NAFLD patients were randomised to a 12-month lifestyle intervention programme involving regular exercise, or to standard care. The primary outcome was remission of NAFLD at Month 12 by proton-magnetic resonance spectroscopy. After the programme, the patients were prospectively followed until Year 6. The Asian body mass index (BMI) cut-off of 25 kg/m 2 was used to define non-obese NAFLD.
RESULTS
Patients were assigned to the intervention (n = 77) and control (n = 77) groups (39 and 38 in each group had baseline BMI <25 and ≥25 kg/m 2 , respectively). More patients in the intervention group achieved the primary outcome than the control group regardless of baseline BMI (non-obese: 67% vs. 18%, p <0.001; obese: 61% vs. 21%, p <0.001). Lifestyle intervention, lower baseline intrahepatic triglyceride, and reduction in body weight and waist circumference were independent factors associated with remission of NAFLD in non-obese patients. Half of non-obese patients achieved remission of NAFLD with 3-5% weight reduction; the same could only be achieved in obese patients with 7-10% weight reduction. By Year 6, non-obese patients in the intervention group remained more likely to maintain weight reduction and alanine aminotransferase normalisation than the control group.
CONCLUSIONS
Lifestyle intervention is effective in treating NAFLD in both non-obese and obese patients. Weight reduction predicts remission of NAFLD in non-obese patients, but a modest weight reduction may be sufficient in this population.
LAY SUMMARY
Some patients with non-alcoholic fatty liver disease (NAFLD) are non-obese. The optimal management of such patients is unclear. In this long-term follow-up study of a clinical trial, we show that remission of NAFLD can be achieved in 67% of non-obese patients after lifestyle intervention. The majority of patients can achieve NAFLD remission with modest weight loss of 3-10%. Non-obese patients are also more likely than obese patients to maintain weight reduction and normal liver enzymes in the long run.",2018,"By Year 6, non-obese patients in the intervention group remained more likely to maintain weight reduction and alanine aminotransferase normalisation than the control group.
","['154 community NAFLD patients', 'patients with non-alcoholic fatty liver disease (NAFLD) are non-obese', 'non-obese patients with non-alcoholic fatty liver disease', 'non-obese patients with NAFLD', 'obese patients', 'patients with non-alcoholic fatty liver disease (NAFLD']","['lifestyle intervention', 'Lifestyle intervention', 'lifestyle intervention programme involving regular exercise, or to standard care']","['maintain weight reduction and alanine aminotransferase normalisation', 'remission of NAFLD', 'maintain weight reduction and normal liver enzymes', 'NAFLD remission with modest weight loss', 'baseline BMI', 'weight reduction', 'baseline intrahepatic triglyceride, and reduction in body weight and waist circumference']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",154.0,0.0656863,"By Year 6, non-obese patients in the intervention group remained more likely to maintain weight reduction and alanine aminotransferase normalisation than the control group.
","[{'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Grace Lai-Hung', 'Initials': 'GL', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ruth Suk-Mei', 'Initials': 'RS', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; Centre for Nutritional Studies, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Sally She-Ting', 'Initials': 'SS', 'LastName': 'Shu', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Bernice Ho-Ki', 'Initials': 'BH', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; Centre for Nutritional Studies, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Liz Sin', 'Initials': 'LS', 'LastName': 'Li', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; Centre for Nutritional Studies, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Angel Mei-Ling', 'Initials': 'AM', 'LastName': 'Chim', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Carmen Ka-Man', 'Initials': 'CK', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Julie Ka-Yu', 'Initials': 'JK', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Winnie Chiu-Wing', 'Initials': 'WC', 'LastName': 'Chu', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; Centre for Nutritional Studies, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Henry Lik-Yuen', 'Initials': 'HL', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong. Electronic address: hlychan@cuhk.edu.hk.'}]",Journal of hepatology,['10.1016/j.jhep.2018.08.011']
1796,31361307,The GH Axis in Relation to Accepting an Early Macronutrient Deficit and Outcome of Critically Ill Patients.,"CONTEXT
Changes in the GH axis during critical illness resemble fasting in healthy adults and contribute to hypercatabolism, which potentially affects outcome. Accepting macronutrient deficits by withholding parenteral nutrition (PN) during the first week in the intensive care unit (ICU; late PN) reduced complications and accelerated recovery as compared with early use of PN (early PN).
OBJECTIVE
To investigate how late PN affects the GH axis in relation to its clinical outcome benefits.
DESIGN
Preplanned subanalysis of the Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients randomized controlled trial.
PARTICIPANTS
A total of 1128 patients for time-course study, 20 patients investigated for nocturnal GH pulsatility, and 600 patients investigated for muscle weakness, with early PN and late PN patients having comparable baseline characteristics.
INTERVENTION
Withholding PN during the first ICU week (late PN) vs early PN.
MAIN OUTCOME MEASURES
Changes in serum GH, IGF-I, IGF-binding protein (IGFBP) 3, and IGFBP1 concentrations from ICU admission to day 4 or last ICU day for patients with a shorter ICU stay (d4/LD) and association in multivariable analyses with likelihood of earlier live ICU discharge, risk of new infection, and muscle weakness.
RESULTS
Late PN attenuated a rise in serum GH and IGF-I (P < 0.0001), did not affect IGFBP3, and attenuated a decrease in IGFBP1 concentrations from admission to d4/LD (P < 0.0001) as compared with early PN. Late PN decreased nonpulsatile (P = 0.005), but not pulsatile, GH secretion. Adjusting the multivariable models for the observed GH axis alterations increased the independent benefit of late PN for all outcomes. GH axis alterations induced by late PN were independently associated with adverse outcomes (P ≤ 0.03).
CONCLUSION
Accepting macronutrient deficits early during critical illness further suppressed the GH axis, which statistically attenuated its clinical outcome benefits.",2019,"Late PN decreased nonpulsatile (P = 0.005), but not pulsatile, GH secretion.","['healthy adults', 'Adult Critically Ill Patients randomized controlled trial', 'Critically Ill Patients', 'A total of 1128 patients for time-course study, 20 patients investigated for nocturnal GH pulsatility, and 600 patients investigated for muscle weakness, with early PN and late PN patients having comparable baseline characteristics']",[],"['serum GH, IGF-I, IGF-binding protein (IGFBP) 3, and IGFBP1 concentrations from ICU admission', 'GH axis alterations', 'IGFBP1 concentrations', 'earlier live ICU discharge, risk of new infection, and muscle weakness', 'serum GH and IGF']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0577317', 'cui_str': 'Pulsatility (attribute)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'IGF-Binding Protein 3'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439633', 'cui_str': 'New infection (qualifier value)'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}]",1128.0,0.104666,"Late PN decreased nonpulsatile (P = 0.005), but not pulsatile, GH secretion.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Van Dyck', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Derese', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vander Perre', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Wouters', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Michaël P', 'Initials': 'MP', 'LastName': 'Casaer', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Hermans', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00842']
1797,32009828,"The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.","Background and rationale
Stroke is considered the most common cause of adult disability. Intensive rehabilitation protocols outperform nonintensive counterparts. The subacute stroke phase represents a potential window to recovery. Virtual reality (VR) has been shown to provide a more stimulating environment, allowing for increased patient compliance. However, the quality of current literature comparing VR with standard therapies is limited. Our aim is to measure the impact of VR versus standard therapy on the recovery of the upper limb motor function in patients with stroke in the early subacute recovery phase.
Method
This is a randomized, controlled trial that will assign 262 patients to tailor-made standard rehabilitation (TMSR) or TMSR plus immersive VR device. The trial will be conducted in an urban rehabilitation clinic in the United States with expertise in the management of poststroke patients. Patients will be 18 to 70 years of age and in the early subacute period (30-90 days post ischemic stroke). The primary outcome will be the change of Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score, measured at baseline and 13 weeks after randomization. The secondary outcome will be the change in the UK Functional Independence Measure and Functional Assessment Measure (UK FIM-FAM) score at the same time points.
Discussion
If the use of VR in the rehabilitation of patients with stroke proves to have a significant impact on their motor recovery, it will constitute an extremely important step into decreasing the functional impairment associated with stroke and the related health care expense burden.",2020,"Our aim is to measure the impact of VR versus standard therapy on the recovery of the upper limb motor function in patients with stroke in the early subacute recovery phase.
","['Patients With Ischemic Stroke in the Early Subacute Recovery Phase', 'patients with stroke', 'Patients will be 18 to 70\u2009years of age and in the early subacute period (30-90\u2009days post ischemic stroke', '262 patients to tailor-made', 'urban rehabilitation clinic in the United States with expertise in the management of poststroke patients', 'patients with stroke in the early subacute recovery phase']","['VR versus standard therapy', 'Rehabilitation-oriented Virtual Reality Device', 'Virtual reality (VR', 'standard rehabilitation (TMSR) or TMSR plus immersive VR device']","['change of Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score', 'change in the UK Functional Independence Measure and Functional Assessment Measure (UK FIM-FAM) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C0451169', 'cui_str': 'Functional assessment measure (assessment scale)'}]",262.0,0.0889503,"Our aim is to measure the impact of VR versus standard therapy on the recovery of the upper limb motor function in patients with stroke in the early subacute recovery phase.
","[{'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Neurology Department, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Vitor A Queiroz', 'Initials': 'VAQ', 'LastName': 'Mauad', 'Affiliation': 'Hematology Department, ABC Medical School, Santo André, Brazil.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Gomez-Rojas', 'Affiliation': 'Occupational Health Department, Alexander von Humboldt School, Lima, Peru.'}, {'ForeName': 'Ammu', 'Initials': 'A', 'LastName': 'Sushea', 'Affiliation': 'Department of Anesthesia and Critical Care, Harvard Medical School Teaching Hospital, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Gelanys', 'Initials': 'G', 'LastName': 'Castro-Tejada', 'Affiliation': 'Regional University Hospital Jose Maria Cabral y Baez (HRUJMCB), Biomedical and Clinical Research Center (CINBIOCLI), Santiago, Dominican Republic.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Michel', 'Affiliation': 'Health Systems and Policy Department, University of Basel, Swiss TPH, Basel, Switzerland.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Liñares', 'Affiliation': 'Department of Pediatric Neurosurgery, SAMIC Pediatric Hospital ""Prof. Dr. Juan Pedro Garrahan,"" Buenos Aires, Argentina.'}, {'ForeName': 'Loise', 'Initials': 'L', 'LastName': 'Pedrosa Salles', 'Affiliation': 'Dentistry Department, Faculty of Health Sciences, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Ludmilla', 'Initials': 'L', 'LastName': 'Candido Santos', 'Affiliation': 'Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, MA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Shan', 'Affiliation': 'Translational Research & Development, TESARO, Inc., Waltham, MA, USA.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Nassir', 'Affiliation': 'Department of Pathology, School of Medicine, Umm Al-Qura University, Mecca, Saudi Arabia.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Montañez-Valverde', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Fabiano', 'Affiliation': 'General Hospital Roberto Santos, Salvador, Brazil.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Danyi', 'Affiliation': ""Lusíada University Centre's Medical School, Santos, Brazil.""}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Hassan Hosseyni', 'Affiliation': 'Neurology Department, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Seerat', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': 'Jawaharlal Nehru Medical College, Belgaum, India.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Ahmad', 'Affiliation': 'Department of Pharmacology & Therapeutics, Hamdard University, Karachi, Pakistan.'}, {'ForeName': 'William Augusto', 'Initials': 'WA', 'LastName': 'Casteleins', 'Affiliation': 'Peritoneal Oncology Surgery Group, Hospital Marcelino Champagnat, Curitiba, Brazil.'}, {'ForeName': 'Alma Tamara', 'Initials': 'AT', 'LastName': 'Sanchez', 'Affiliation': 'Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, MA, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Fouad', 'Affiliation': 'Clinical Pharmacy Department, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Jacome', 'Affiliation': 'Country Clinic, Andes University, Bogota, Colombia.'}, {'ForeName': 'Mariana Sanali', 'Initials': 'MS', 'LastName': 'Moura de Oliveira Paiva', 'Affiliation': 'Onofre Lopes University Hospital, Petropolis, Brazil.'}, {'ForeName': 'Ana Gabriela', 'Initials': 'AG', 'LastName': 'Saavedra Ruiz', 'Affiliation': 'Department of Public Health, Montreal University, Montreal, QC, Canada.'}, {'ForeName': 'Rubens A', 'Initials': 'RA', 'LastName': 'Grochowski', 'Affiliation': 'Minas Gerais Ophthalmology Hospital, Minas Gerais, Brazil.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Toyama', 'Affiliation': 'School of Public Health, Department of Health Informatics, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hibatalla', 'Initials': 'H', 'LastName': 'Nagi', 'Affiliation': 'Neurology Department, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Marcella Zanini', 'Initials': 'MZ', 'LastName': 'Sarvodelli', 'Affiliation': 'ABC Medical School, Santo André, Brazil.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Halalau', 'Affiliation': 'Internal Medicine Department, Beaumont Hospital, Royal Oak, MI, USA.'}]",Journal of central nervous system disease,['10.1177/1179573519899471']
1798,28442950,Effect of intranasal dexmedetomidine on emergence agitation after sevoflurane anesthesia in children undergoing tonsillectomy and/or adenoidectomy.,"BACKGROUND
Emergence agitation (EA) after sevoflurane anesthesia is common in children during recovery from general anesthesia and may result in postoperative complications. This study investigated safety and effectiveness of intranasal dexmedetomidine in reducing the incidence and severity of EA.
METHODS
This prospective, randomized double-blinded controlled trial included 86 patients scheduled for the tonsillectomy and/or adenoidectomy under general anesthesia with sevoflurane. They were randomly allocated into two groups. Group D received intranasal dexmedetomidine at 1 μg/kg, and Group C received intranasal saline 0.9% after the induction of general anesthesia. Four-point agitation scale and Face, Legs, Activity, Cry and Consolability (FLACC) scale for pain assessment were measured at six time points (after extubation, leaving the operating room, on arrival to postanesthesia care unit [PACU], 10, 20, and 30 min after arrival in PACU). Extubation, emergence, and discharge times were recorded in addition to any adverse effects.
RESULTS
There was a significant difference in the incidence of EA between Groups D and C (6.98% and 58%, respectively, with P = 0.001). The median four-point agitation scales and the median scores of FLACC pain scales of Group D were significantly lower than those of Group C at the all six time points with P < 0.05. Extubation, emergence, and discharge times were comparable in both groups, and none of the subjects reported any adverse effects.
CONCLUSION
This study demonstrates that a 1 μg/kg dose of intranasal dexmedetomidine administered after the induction of anesthesia reduces post-sevoflurane incidence and severity of EA in children undergone tonsillectomy and/or adenoidectomy with no adverse effects and smooth recovery profile.",2017,"Extubation, emergence, and discharge times were comparable in both groups, and none of the subjects reported any adverse effects.
","['86 patients scheduled for the tonsillectomy and/or adenoidectomy under general anesthesia with', 'children undergone tonsillectomy and/or adenoidectomy', 'children undergoing tonsillectomy and/or adenoidectomy']","['intranasal dexmedetomidine', 'sevoflurane anesthesia', 'intranasal saline', 'sevoflurane']","['median four-point agitation scales and the median scores of FLACC pain scales', 'emergence agitation', 'Extubation, emergence, and discharge times', 'adverse effects', 'Four-point agitation scale and Face, Legs, Activity, Cry and Consolability (FLACC) scale for pain assessment', 'incidence of EA']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",86.0,0.48413,"Extubation, emergence, and discharge times were comparable in both groups, and none of the subjects reported any adverse effects.
","[{'ForeName': 'Ahmed Mostafa Abd', 'Initials': 'AMA', 'LastName': 'El-Hamid', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Hany Mahmoud', 'Initials': 'HM', 'LastName': 'Yassin', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Fayoum University, Fayoum, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.203020']
1799,20298928,Atorvastatin causes insulin resistance and increases ambient glycemia in hypercholesterolemic patients.,"OBJECTIVES
We investigated whether atorvastatin might decrease insulin sensitivity and increase ambient glycemia in hypercholesterolemic patients.
BACKGROUND
Clinical trials suggest that some statin treatments might increase the incidence of diabetes despite reductions in low-density lipoprotein (LDL) cholesterol and improvement in endothelial dysfunction.
METHODS
A randomized, single-blind, placebo-controlled parallel study was conducted in 44 patients taking placebo and in 42, 44, 43, and 40 patients given daily atorvastatin 10, 20, 40, and 80 mg, respectively, during a 2-month treatment period.
RESULTS
Atorvastatin 10, 20, 40, and 80 mg significantly reduced LDL cholesterol (39%, 47%, 52%, and 56%, respectively) and apolipoprotein B levels (33%, 37%, 42%, and 46%, respectively) after 2 months of therapy when compared with either baseline (all p < 0.001 by paired t test) or placebo (p < 0.001 by analysis of variance [ANOVA]). Atorvastatin 10, 20, 40, and 80 mg significantly increased fasting plasma insulin (mean changes: 25%, 42%, 31%, and 45%, respectively) and glycated hemoglobin levels (2%, 5%, 5%, and 5%, respectively) when compared with either baseline (all p < 0.05 by paired t test) or placebo (p = 0.009 for insulin and p = 0.008 for glycated hemoglobin by ANOVA). Atorvastatin 10, 20, 40, and 80 mg decreased insulin sensitivity (1%, 3%, 3%, and 4%, respectively) when compared with either baseline (p = 0.312, p = 0.008, p < 0.001, and p = 0.008, respectively, by paired t test) or placebo (p = 0.033 by ANOVA).
CONCLUSIONS
Despite beneficial reductions in LDL cholesterol and apolipoprotein B, atorvastatin treatment resulted in significant increases in fasting insulin and glycated hemoglobin levels consistent with insulin resistance and increased ambient glycemia in hypercholesterolemic patients. (Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients; NCT00745836).",2010,"Atorvastatin 10, 20, 40, and 80 mg significantly increased fasting plasma insulin (mean changes: 25%, 42%, 31%, and 45%, respectively) and glycated hemoglobin levels (2%, 5%, 5%, and 5%, respectively) when compared with either baseline (all p < 0.05 by paired t test) or placebo (p = 0.009 for insulin and p = 0.008 for glycated hemoglobin by ANOVA).","['44 patients taking placebo and in 42, 44, 43, and 40 patients given daily atorvastatin 10, 20, 40, and 80 mg, respectively, during a 2-month treatment period', 'hypercholesterolemic patients']","['Atorvastatin', 'atorvastatin', 'placebo']","['apolipoprotein B levels', 'ambient glycemia', 'low-density lipoprotein (LDL) cholesterol', 'LDL cholesterol', 'fasting plasma insulin', 'Adiponectin Levels and Insulin Sensitivity', 'glycated hemoglobin levels', 'fasting insulin and glycated hemoglobin levels', 'insulin sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}]",,0.18091,"Atorvastatin 10, 20, 40, and 80 mg significantly increased fasting plasma insulin (mean changes: 25%, 42%, 31%, and 45%, respectively) and glycated hemoglobin levels (2%, 5%, 5%, and 5%, respectively) when compared with either baseline (all p < 0.05 by paired t test) or placebo (p = 0.009 for insulin and p = 0.008 for glycated hemoglobin by ANOVA).","[{'ForeName': 'Kwang Kon', 'Initials': 'KK', 'LastName': 'Koh', 'Affiliation': 'Department of Cardiology, Gachon University, Gil Medical Center, Incheon, Korea. Electronic address: kwangk@gilhospital.com.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Quon', 'Affiliation': 'Diabetes Unit, National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Seung Hwan', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, Gachon University, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Yonghee', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, University of Seoul, Seoul, Korea.'}, {'ForeName': 'Soo Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Gachon University, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Eak Kyun', 'Initials': 'EK', 'LastName': 'Shin', 'Affiliation': 'Department of Cardiology, Gachon University, Gil Medical Center, Incheon, Korea.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2009.10.053']
1800,30134777,Exploring the uptake and implementation of tele-monitored home-exercise programmes in adults with Parkinson's disease: A mixed-methods pilot study.,"BACKGROUND
People with Parkinson's disease experience numerous barriers to exercise participation at fitness facilities. Advances in tele-monitoring technologies create alternative channels for managing and supervising exercise programmes in the home. However, the success of these programmes will depend on participants' perceptions of using the technology and their exercise adherence. Thus, this pilot explored the uptake and implementation of two common methods of Internet-exercise training in Parkinson's disease.
METHODS
Twenty adults with Parkinson's disease were randomized into either: telecoach-assisted exercise (TAE) or self-regulated exercise (SRE) groups. Both groups received the same eight-week exercise prescription (combined strength and aerobic exercise) and telehealth system that streamed and recorded vital signs and exercise data. TAE participants exercised under a telecoach's supervision via videoconferencing. SRE participants independently managed their exercise training. Quantitative data were described and qualitative data underwent thematic analysis.
RESULTS
Quantitative results demonstrated that TAE participants achieved strong attendance (99.2%), whereas SRE participants demonstrated 35.9% lower attendance, 48% less total time exercising, and 74.5% less time exercising at moderate intensity. Qualitatively, TAE participants reported overtly favourable programme experiences and that assistance from a telecoach enhanced their exercise motivation. SRE participants noted several challenges that impeded adherence.
CONCLUSION
Findings demonstrate that adults with Parkinson's disease acknowledge benefits of exercising through a telehealth system and are open to utilizing this channel as a means of exercise. However, human-interactive support may be required to overcome unique impediments to participation. Study findings warrant validation in larger trials that can transfer the success of TAE towards more scalable methods of delivery.",2020,Conclusion Findings demonstrate that adults with Parkinson's disease acknowledge benefits of exercising through a telehealth system and are open to utilizing this channel as a means of exercise.,"[""TAE participants exercised under a telecoach's supervision via videoconferencing"", ""adults with Parkinson's disease"", ""Twenty adults with Parkinson's disease"", ""Parkinson's disease"", "" People with Parkinson's disease experience""]","['tele-monitored home-exercise programmes', 'exercise training', 'TAE', 'Internet-exercise training', 'same eight-week exercise prescription (combined strength and aerobic exercise) and telehealth system that streamed and recorded vital signs and exercise data', 'SRE', 'telecoach-assisted exercise (TAE) or self-regulated exercise (SRE']","['strong attendance', 'total time exercising']","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0442540', 'cui_str': 'Streams'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0518766'}, {'cui': 'C0203989', 'cui_str': 'Assisting exercise (regime/therapy)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",20.0,0.0382547,Conclusion Findings demonstrate that adults with Parkinson's disease acknowledge benefits of exercising through a telehealth system and are open to utilizing this channel as a means of exercise.,"[{'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Lai', 'Affiliation': 'Electrical & Computer Engineering University of Alabama at Birmingham, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Bond', 'Affiliation': 'Electrical & Computer Engineering University of Alabama at Birmingham, USA.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Electrical & Computer Engineering University of Alabama at Birmingham, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Barstow', 'Affiliation': 'Electrical & Computer Engineering University of Alabama at Birmingham, USA.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Jovanov', 'Affiliation': 'Electrical & Computer Engineering University of Alabama at Birmingham, USA.'}, {'ForeName': 'C Scott', 'Initials': 'CS', 'LastName': 'Bickel', 'Affiliation': 'Electrical & Computer Engineering University of Alabama at Birmingham, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18794315']
1801,28442951,"Renal water conservation determines the increase in body weight after surgery: A randomized, controlled trial.","BACKGROUND
The present study was undertaken to identify factors that correlate with the gain in body weight after surgery.
METHODS
Twenty-one patients (median age of 49 years) were randomized to receive either Ringer × s acetate or 6% dextran 70 as their first infusion fluid during cholecystectomy or hysterectomy. Each patient's body weight was measured before the surgery and on the first postoperative morning. Blood and urine samples were analyzed for signs of stress, inflammation, and kidney injury. The fluid retention index (FRI), which reflects how strongly the kidneys excrete or retain fluid, was also calculated.
RESULTS
The body weight increased by a median of 0.4 kg in the crystalloid fluid group and by 1.0 kg in the colloid fluid group (maximum 2.5 kg, P < 0.01). This difference was due to less urinary excretion after surgery in the colloid group ( P < 0.03). The increase in body weight did not correlate with the infused fluid volume, the plasma concentrations of C-reactive protein or cortisol, or the urinary excretion of albumin, cortisol, or neutrophil gelatinase-associated lipocalin. However, the body weight increased with the postoperative FRI score ( r = 0.64; P < 0.003) and with the surgery-induced change in FRI score ( r = 0.72; P < 0.002).
CONCLUSION
How strongly the kidneys excrete or retain fluid, which can be assessed by urine sampling, was the strongest indicator of the increase in body weight during the day of surgery. The amount of fluid alone did not correlate with the gain in body weight.",2017,"The increase in body weight did not correlate with the infused fluid volume, the plasma concentrations of C-reactive protein or cortisol, or the urinary excretion of albumin, cortisol, or neutrophil gelatinase-associated lipocalin.",['Twenty-one patients (median age of 49 years'],['Ringer × s acetate or 6% dextran 70 as their first infusion fluid during cholecystectomy or hysterectomy'],"['urinary excretion', 'postoperative FRI score', 'FRI score', 'plasma concentrations of C-reactive protein or cortisol, or the urinary excretion of albumin, cortisol, or neutrophil gelatinase-associated lipocalin', 'fluid retention index (FRI', 'gain in body weight', 'body weight']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0011795', 'cui_str': 'dextran HM'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0268000', 'cui_str': 'Body fluid retention (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.063391,"The increase in body weight did not correlate with the infused fluid volume, the plasma concentrations of C-reactive protein or cortisol, or the urinary excretion of albumin, cortisol, or neutrophil gelatinase-associated lipocalin.","[{'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hahn', 'Affiliation': 'Department of Patient Safety and Quality, Research Unit, Södertälje Hospital, Södertälje, Sweden.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.203018']
1802,28442953,Role of flupirtine in reducing preoperative anxiety of patients undergoing craniotomy procedure.,"BACKGROUND
Kv7 neuronal channels are recognized as a potential drug target for anxiolytic effects. We hypothesize that flupirtine as a potassium channel opener would effectively reduce the preoperative anxiety of patients undergoing craniotomy procedure.
METHODS
In prospective-double-blinded fashion, 124 counseled patients were randomized to receive 5 sequential doses of capsule flupirtine 100 mg (F Group) or physically similar starch capsules (C Group), at 12 h intervals during preoperative hospitalization. Primary outcome included various aspects of patient anxiety measured by visual analog scale (VAS) just before preoperative counseling and 2 h after the completion of drug regimen under trial. Statistical tool included Mann-Whitney U-test and Wilcoxon signed rank test.
RESULTS
Baseline VAS scores were higher for fear of surgical harm, being at the mercy of medical staff, and not awakening after surgery. A significant decline in VAS scores was observed after the completion of drug regime, but to a higher extent in flupirtine-treated patients; it achieved statistical significance in comparison to Group C. No side effects were observed in any patient.
CONCLUSION
Flupirtine is a useful premedication in conjunction with behavioral therapy to alleviate patient anxiety during the preoperative period.",2017,"A significant decline in VAS scores was observed after the completion of drug regime, but to a higher extent in flupirtine-treated patients; it achieved statistical significance in comparison to Group C. No side effects were observed in any patient.
","['patients undergoing craniotomy procedure', '124 counseled patients']","['Flupirtine', 'capsule flupirtine 100 mg (F Group) or physically similar starch capsules', 'flupirtine']","['various aspects of patient anxiety measured by visual analog scale (VAS', 'VAS scores', 'preoperative anxiety', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}]","[{'cui': 'C0060583', 'cui_str': 'flupirtine'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",124.0,0.0767708,"A significant decline in VAS scores was observed after the completion of drug regime, but to a higher extent in flupirtine-treated patients; it achieved statistical significance in comparison to Group C. No side effects were observed in any patient.
","[{'ForeName': 'Ghanshyam', 'Initials': 'G', 'LastName': 'Yadav', 'Affiliation': 'Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Malkhan', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.203028']
1803,31521682,CABG Improves Outcomes in Patients With Ischemic Cardiomyopathy: 10-Year Follow-Up of the STICH Trial.,"OBJECTIVES
The authors investigated the impact of coronary artery bypass grafting (CABG) on first and recurrent hospitalization in this population.
BACKGROUND
In the STICH (Surgical Treatment for Ischemic Heart Failure) trial, CABG reduced all-cause death and hospitalization in patients with and ischemic cardiomyopathy and left ventricular ejection fraction <35%.
METHODS
A total of 1,212 patients were randomized (610 to CABG + optimal medical therapy [CABG] and 602 to optimal medical therapy alone [MED] alone) and followed for a median of 9.8 years. All-cause and cause-specific hospitalizations were analyzed as time-to-first-event and as recurrent event analysis.
RESULTS
Of the 1,212 patients, 757 died (62.4%) and 732 (60.4%) were hospitalized at least once, for a total of 2,549 total all-cause hospitalizations. Most hospitalizations (66.2%) were for cardiovascular causes, of which approximately one-half (907 or 52.9%) were for heart failure. More than 70% of all hospitalizations (1,817 or 71.3%) were recurrent events. The CABG group experienced fewer all-cause hospitalizations in the time-to-first-event (349 CABG vs. 383 MED, adjusted hazard ratio [HR]: 0.85; 95% confidence interval [CI]: 0.74 to 0.98; p = 0.03) and in recurrent event analyses (1,199 CABG vs. 1,350 MED, HR: 0.78, 95% CI: 0.65 to 0.94; p < 0.001). This was driven by fewer total cardiovascular (CV) hospitalizations (744 vs. 968; p < 0.001, adjusted HR: 0.66, 95% CI: 0.55 to 0.81; p = 0.001), the majority of which were due to HF (395 vs. 512; p < 0.001, adjusted HR: 0.68, 95% CI: 0.52-0.89; p = 0.005). We did not observe a difference in non-CV events.
CONCLUSIONS
CABG reduces all-cause, CV, and HF hospitalizations in time-to-first-event and recurrent event analyses. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease [STICH]; NCT00023595).",2019,"This was driven by fewer total cardiovascular (CV) hospitalizations (744 vs. 968; p < 0.001, adjusted HR: 0.66, 95% CI: 0.55 to 0.81; p = 0.001), the majority of which were due to HF (395 vs. 512; p < 0.001, adjusted HR: 0.68, 95% CI: 0.52-0.89; p = 0.005).","['Patients With Ischemic Cardiomyopathy', '1,212 patients were randomized (610 to', 'patients with and ischemic cardiomyopathy and left ventricular ejection fraction\xa0<35', '1,212 patients']","['CABG\xa0+ optimal medical therapy [CABG', 'coronary artery bypass grafting (CABG', 'CABG', 'optimal medical therapy alone [MED] alone']","['total cardiovascular (CV) hospitalizations', 'recurrent events', 'heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",1212.0,0.0583005,"This was driven by fewer total cardiovascular (CV) hospitalizations (744 vs. 968; p < 0.001, adjusted HR: 0.66, 95% CI: 0.55 to 0.81; p = 0.001), the majority of which were due to HF (395 vs. 512; p < 0.001, adjusted HR: 0.68, 95% CI: 0.52-0.89; p = 0.005).","[{'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'Libin Cardiovascular Institute and University of Calgary Medical Centre, Calgary, Canada. Electronic address: howlettjonathan@gmail.com.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Durham, North Carolina.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Serenella', 'Initials': 'S', 'LastName': 'Castelvecchio', 'Affiliation': 'Istituto Di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, San Donato Milanese, Milan, Italy.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Cherniavsky', 'Affiliation': 'E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Novosibirsk, Russia.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Sueta', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Ambuj', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, New York City, New York.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Wurm', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Drazner', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Andersson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Goteborg, Sweden.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Batlle', 'Affiliation': 'Centro de Investigación Cardiovascular Uruguayo Casa De Galicia, Montevideo, Uruguay.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Chrzanowski', 'Affiliation': 'Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis University, Budapest, Budapest, Hungary.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Carson', 'Affiliation': 'Washington VA Medical Center, Washington, DC.'}, {'ForeName': 'Patrice M', 'Initials': 'PM', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Institutes of Health, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Durham, North Carolina.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2019.04.018']
1804,30976787,Uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation: the ELIMINATE-AF trial.,"AIMS
Edoxaban is a direct factor Xa inhibitor approved for stroke prevention in atrial fibrillation (AF). Uninterrupted edoxaban therapy in patients undergoing AF ablation has not been tested.
METHODS AND RESULTS
The ELIMINATE-AF trial, a multinational, multicentre, randomized, open-label, parallel-group study, was conducted to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for dose reduction) vs. vitamin K antagonists (VKAs) in AF patients undergoing catheter ablation. Patients were randomized 2:1 to edoxaban vs. VKA. The primary endpoint (per-protocol population) was time to first occurrence of all-cause death, stroke, or International Society of Thrombosis and Haemostasis-defined major bleeding during the period from the end of the ablation procedure to end of treatment (90 days). Overall, 632 patients were enrolled, 614 randomized, and 553 received study drug and underwent ablation; 177 subjects underwent brain magnetic resonance imaging to assess silent cerebral infarcts. The primary endpoint (only major bleeds occurred) was observed in 0.3% (1 patient) on edoxaban and 2.0% (2 patients) on VKA [hazard ratio (95% confidence interval): 0.16 (0.02-1.73)]. In the ablation population (modified intent-to-treat population including patients with ablation), the primary endpoint was observed in 2.7% of edoxaban (N = 10) and 1.7% of VKA patients (N = 3) between start of ablation and end of treatment. There were one ischaemic and one haemorrhagic stroke, both in patients on edoxaban. Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62).
CONCLUSION
Uninterrupted edoxaban therapy represents an alternative to uninterrupted VKA treatment in patients undergoing AF ablation.",2019,"Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62).
","['patients undergoing AF ablation', '632 patients were enrolled, 614 randomized, and 553 received study drug and underwent ablation; 177 subjects underwent', 'AF patients undergoing catheter ablation', 'atrial fibrillation']","['Uninterrupted edoxaban therapy', 'Edoxaban', 'vitamin K antagonists (VKAs', 'edoxaban vs. VKA', 'edoxaban', 'Uninterrupted edoxaban vs. vitamin K antagonists', 'edoxaban therapy', 'brain magnetic resonance imaging']","['safety and efficacy', 'time to first occurrence of all-cause death, stroke, or International Society of Thrombosis and Haemostasis-defined major bleeding', 'Cerebral microemboli', 'major bleeds occurred', 'haemorrhagic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0333227', 'cui_str': 'Microembolus (morphologic abnormality)'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}]",632.0,0.0578728,"Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62).
","[{'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Division of Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Theodor-Stern-Kai 7, Frankfurt am Main, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, Blackshaw Road, London, UK.""}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Cappato', 'Affiliation': 'Arrhythmia and Electrophysiology Research Center, Humanitas Clinical and Research Center, Via A. Manzoni 56, Rozzano (MI), Italy.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Medical Faculty of the University Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbüchel', 'Affiliation': 'Department of Cardiology, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, Edegem, Belgium.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'Department of Cardiology, Hospital Clinic, University of Barcelona, Carrer de Villarroel 170, Barcelona, Spain.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Division of Cardiology, Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, 1403 29th Street NW, Calgary, Alberta, Canada.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Abozguia', 'Affiliation': 'Blackpool Teaching Hospitals NHS Lancashire Cardiac Centre, Whinney Heys Road, Blackpool, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Grimaldi', 'Affiliation': 'Department of Cardiology - Arrhythmias Unit, Ospedale ""F. Miulli"" Acquaviva delle Fonti, Strada Provinciale Acquaviva - Santeramo, Km4 Acquaviva delle Fonti, Bari, Italy.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Rauer', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Zielstattstr. 48, München, Germany.'}, {'ForeName': 'Paul-Egbert', 'Initials': 'PE', 'LastName': 'Reimitz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Zielstattstr. 48, München, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Smolnik', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Zielstattstr. 48, München, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mönninghoff', 'Affiliation': 'Institute for Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, Essen, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Kautzner', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine, Videnska 1958/9, Prague, Czech Republic.'}]",European heart journal,['10.1093/eurheartj/ehz190']
1805,31313296,Concomitant Intake of Coca-Cola to Manage the Drug-Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers.,"We aimed to evaluate the effect of the acid beverage Coca-Cola on the pharmacokinetics of velpatasvir (VEL) when given with omeprazole. This was an open-label, randomized, crossover trial in 11 healthy adults. A single dose of sofosbuvir/velpatasvir (SOF/VEL) 400/100 mg was administered alone (reference) or with omeprazole 40 mg once daily with water (intervention I); in the intervention II arm, omeprazole 40 mg was combined with 250 mL of Coca-Cola. Geometric mean ratios (GMRs) were calculated for VEL area under the concentration-time curve from zero to infinity (AUC 0-inf ) and maximum plasma concentration (C max ). VEL exposure was reduced by 26.7% when SOF/VEL was coadministered with omeprazole vs. reference: GMRs (90% confidence interval (CI)) were 73.3% (55.6-96.8) and 69.1% (52.3-91.2) for AUC 0-inf and C max , respectively. Intake of SOF/VEL with Coca-Cola compensated for the interaction with omeprazole and resulted in a higher VEL exposure. GMRs (90% CI) were 161.6% (122.4-213.3) for AUC 0-inf and 143.9% (109.0-190.0) for C max . Therefore, Coca-Cola can be used to overcome the drug-drug interaction between VEL and omeprazole.",2019,GMRs (90% CI) were 161.6% (122.4-213.3) for AUC 0-inf and 143.9% (109.0-190.0) for C max .,"['11 healthy adults', 'Healthy Volunteers']","['Omeprazole', 'sofosbuvir/velpatasvir (SOF/VEL) 400/100', 'omeprazole 40\xa0mg once daily with water (intervention', 'omeprazole 40\xa0mg was combined with 250\xa0mL of Coca-Cola', 'acid beverage Coca-Cola', 'omeprazole']","['Geometric mean ratios (GMRs', 'GMRs', 'VEL exposure']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4271578', 'cui_str': 'sofosbuvir / velpatasvir'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1602244', 'cui_str': 'Omeprazole 40 MG [Prilosec]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0009169', 'cui_str': 'Erythroxylon'}, {'cui': 'C0684195', 'cui_str': 'Cola'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",11.0,0.0435659,GMRs (90% CI) were 161.6% (122.4-213.3) for AUC 0-inf and 143.9% (109.0-190.0) for C max .,"[{'ForeName': 'Minou', 'Initials': 'M', 'LastName': 'van Seyen', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Evertine J', 'Initials': 'EJ', 'LastName': 'Abbink', 'Affiliation': 'Radboudumc Technology Center Clinical Studies, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1569']
1806,28334685,Serum IFN-γ-induced protein 10 (IP-10) as a biomarker for severity of acute respiratory infection in healthy adults.,"BACKGROUND
The inflammatory chemokine, interferon-gamma inducible protein of 10kDa (IP-10), is a biomarker associated with several conditions.
OBJECTIVES
This study investigated serum concentrations of IP-10 in healthy individuals who developed acute respiratory infection (ARI). The hypothesis is that serum IP-10 concentrations correlate with ARI severity and detection of viral pathogens.
STUDY DESIGN
Data come from a randomized controlled trial measuring the effects of mindfulness meditation or exercise on ARI (Clinical Trials ID: NCT01654289). Healthy adults ages 30-69 were followed for a single season for ARI incidence and severity. This trial is ongoing, and the investigators are still blinded. When a participant reported ARI symptoms, nasal swab and lavage for PCR-based viral identification and blood samples were collected within the first 72h of ARI symptoms. Serum IP-10 concentrations were measured by ELISA (R&D Systems, Inc., Quantikine ELISA, Minneapolis, MN). ARI severity was measured using the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24) until the ARI episode resolved.
RESULTS
Serum IP-10 concentrations from 225 ARI episodes correlated with ARI global severity (rho 0.28 [95% CI: 0.15-0.39]; p<0.001). IP-10 concentrations were higher with an ARI in which a viral pathogen was detected compared to no viral pathogen detected (median 366pg/ml [IQR: 227-486] vs 163pg/ml [IQR: 127-295], p<0.0001). Influenza infections had higher IP-10 concentrations than coronavirus, enterovirus or rhinovirus, and paramyxovirus.
CONCLUSION
Serum IP-10 concentration correlates with ARI global severity. Also, IP-10 concentration measured early in the course of the ARI correlates with the daily severity, duration, and illness symptoms.",2017,"Influenza infections had higher IP-10 concentrations than coronavirus, enterovirus or rhinovirus, and paramyxovirus.
","['healthy individuals who developed acute respiratory infection (ARI', 'Healthy adults ages 30-69', 'healthy adults']",['mindfulness meditation or exercise'],"['IP-10 concentration', 'IP-10 concentrations', 'ARI symptoms, nasal swab and lavage for PCR-based viral identification and blood samples', 'ARI global severity', 'ARI severity', 'Serum IP-10 concentrations']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0663981,"Influenza infections had higher IP-10 concentrations than coronavirus, enterovirus or rhinovirus, and paramyxovirus.
","[{'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Hayney', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, United States. Electronic address: mary.hayney@wisc.edu.'}, {'ForeName': 'Kelsey M', 'Initials': 'KM', 'LastName': 'Henriquez', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Jodi H', 'Initials': 'JH', 'LastName': 'Barnet', 'Affiliation': 'Department of Family Medicine, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Tola', 'Initials': 'T', 'LastName': 'Ewers', 'Affiliation': 'Department of Family Medicine, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Champion', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Flannery', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barrett', 'Affiliation': 'Department of Family Medicine, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, United States.'}]",Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology,['10.1016/j.jcv.2017.03.003']
1807,30681726,Low Risk of Variceal Bleeding in Patients With Cirrhosis After Variceal Screening Stratified by Liver/Spleen Stiffness.,"We previously demonstrated the possible noninferiority of a screening strategy for varices guided by liver and spleen stiffness measurement (LSSM) compared to universal endoscopic screening in detecting clinically significant varices in patients with cirrhosis. We now report the long-term outcome of the patients recruited in this trial for incident variceal bleeding and other hepatic events. This was a prospective follow-up study of a noninferiority, open-label, randomized controlled trial (NCT02024347) of 548 adult patients with known chronic liver diseases, radiological evidence of liver cirrhosis, and compensated liver function. The primary outcome of this prospective study was incident variceal bleeding confirmed with upper endoscopy. Between October 2013 and June 2016, 548 patients were randomized to an LSSM arm (n = 274) and a conventional arm (n = 274). Patients in both study arms were predominantly middle-aged men (mean age 59 years, male 68.9%) with viral hepatitis-related cirrhosis (85%). Upper endoscopy examination was performed in 127 (46.4%) patients in the LSSM arm and 263 (96.0%) in the conventional arm. During the follow-up period of 41.3 ± 12.6 months, 12/274 patients in the LSSM arm (4.4%) and 11/274 in the conventional arm (4.0%) developed incident variceal bleeding (log-rank test P = 0.724). The incident rates of hepatic events were also similar in both arms (P = 0.327). Conclusions: Patients with liver cirrhosis who had undergone LSSM-guided variceal screening were at similarly low risk of incident variceal bleeding in the future; patients with cirrhosis may first have LSSM measured to save up to half of the upper endoscopy examinations.",2019,Upper endoscopy examination was performed in 127 (46.4%) patients in the LSSM arm and 263 (96.0%) in the conventional arm.,"['Patients in both study arms were predominantly middle-aged men (mean age 59 years, male 68.9%) with viral hepatitis-related cirrhosis (85', 'Between October 2013 and June 2016, 548 patients', 'patients recruited in this trial for incident variceal bleeding and other hepatic events', 'Patients With Cirrhosis', 'Conclusions: Patients with liver cirrhosis who had undergone LSSM-guided variceal screening', '548 adult patients with known chronic liver diseases, radiological evidence of liver cirrhosis, and compensated liver function', 'patients with cirrhosis']","['LSSM', 'universal endoscopic screening']","['incident rates of hepatic events', 'Upper endoscopy examination', 'incident variceal bleeding', 'incident variceal bleeding confirmed with upper endoscopy', 'Low Risk of Variceal Bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]",548.0,0.131328,Upper endoscopy examination was performed in 127 (46.4%) patients in the LSSM arm and 263 (96.0%) in the conventional arm.,"[{'ForeName': 'Grace Lai-Hung', 'Initials': 'GL', 'LastName': 'Wong', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Lilian Yan', 'Initials': 'LY', 'LastName': 'Liang', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Kwok', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Aric Josun', 'Initials': 'AJ', 'LastName': 'Hui', 'Affiliation': 'Alice Ho Miu Ling Nethersole Hospital, Hong Kong.'}, {'ForeName': 'Yee-Kit', 'Initials': 'YK', 'LastName': 'Tse', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Henry Lik-Yuen', 'Initials': 'HL', 'LastName': 'Chan', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30522']
1808,28148474,Text Messaging to Improve Hypertension Medication Adherence in African Americans From Primary Care and Emergency Department Settings: Results From Two Randomized Feasibility Studies.,"BACKGROUND
Hypertension (HTN) is an important problem in the United States, with an estimated 78 million Americans aged 20 years and older suffering from this condition. Health disparities related to HTN are common in the United States, with African Americans suffering from greater prevalence of the condition than whites, as well as greater severity, earlier onset, and more complications. Medication adherence is an important component of HTN management, but adherence is often poor, and simply forgetting to take medications is often cited as a reason. Mobile health (mHealth) strategies have the potential to be a low-cost and effective method for improving medication adherence that also has broad reach.
OBJECTIVE
Our goal was to determine the feasibility, acceptability, and preliminary clinical effectiveness of BPMED, an intervention designed to improve medication adherence among African Americans with uncontrolled HTN, through fully automated text messaging support.
METHODS
We conducted two parallel, unblinded randomized controlled pilot trials with African-American patients who had uncontrolled HTN, recruited from primary care and emergency department (ED) settings. In each trial, participants were randomized to receive either usual care or the BPMED intervention for one month. Data were collected in-person at baseline and one-month follow-up, assessing the effect on medication adherence, systolic and diastolic blood pressure (SBP and DBP), medication adherence self-efficacy, and participant satisfaction. Data for both randomized controlled pilot trials were analyzed separately and combined.
RESULTS
A total of 58 primary care and 65 ED participants were recruited with retention rates of 91% (53/58) and 88% (57/65), respectively. BPMED participants consistently showed numerically greater, yet nonsignificant, improvements in measures of medication adherence (mean change 0.9, SD 2.0 vs mean change 0.5, SD 1.5, P=.26), SBP (mean change -12.6, SD 24.0 vs mean change -11.3, SD 25.5 mm Hg, P=.78), and DBP (mean change -4.9, SD 13.1 mm Hg vs mean change -3.3, SD 14.3 mm Hg, P=.54). Control and BPMED participants had slight improvements to medication adherence self-efficacy (mean change 0.8, SD 9.8 vs mean change 0.7, SD 7.0) with no significant differences found between groups (P=.92). On linear regression analysis, baseline SBP was the only predictor of SBP change; participants with higher SBP at enrollment exhibited significantly greater improvements at one-month follow-up (β=-0.63, P<.001). In total, 94% (51/54) of BPMED participants agreed/strongly agreed that they were satisfied with the program, regardless of pilot setting.
CONCLUSIONS
Use of text message reminders to improve medication adherence is a feasible and acceptable approach among African Americans with uncontrolled HTN. Although differences in actual medication adherence and blood pressure between BPMED and usual care controls were not significant, patterns of improvement in the BPMED condition suggest that text message medication reminders may have an effect and fully powered investigations with longer-term follow-up are warranted.
TRIAL REGISTRATION
Clinicaltrials.gov NCT01465217; https://clinicaltrials.gov/ct2/show/NCT01465217 (Archived by WebCite at http://www.webcitation.org/6V0tto0lZ).",2017,"Although differences in actual medication adherence and blood pressure between BPMED and usual care controls were not significant, patterns of improvement in the BPMED condition suggest that text message medication reminders may have an effect and fully powered investigations with longer-term follow-up are warranted.
","['78 million Americans aged 20 years and older suffering from this condition', 'African-American patients who had uncontrolled HTN, recruited from primary care and emergency department (ED) settings', 'A total of 58 primary care and 65 ED participants were recruited with retention rates of 91% (53/58) and 88% (57/65), respectively', 'African Americans with uncontrolled HTN', 'African Americans From Primary Care and Emergency Department Settings']","['Text Messaging', 'usual care or the BPMED intervention', 'BPMED']","['medication adherence self-efficacy', 'DBP', 'medication adherence', 'medication adherence, systolic and diastolic blood pressure (SBP and DBP), medication adherence self-efficacy, and participant satisfaction', 'SBP', 'actual medication adherence and blood pressure', 'Hypertension Medication Adherence']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",58.0,0.111988,"Although differences in actual medication adherence and blood pressure between BPMED and usual care controls were not significant, patterns of improvement in the BPMED condition suggest that text message medication reminders may have an effect and fully powered investigations with longer-term follow-up are warranted.
","[{'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Buis', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Hirzel', 'Affiliation': 'College of Nursing, Wayne State University, Detroit, MI, United States.'}, {'ForeName': 'Rachelle M', 'Initials': 'RM', 'LastName': 'Dawood', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Wayne State University, Detroit, MI, United States.'}, {'ForeName': 'Katee L', 'Initials': 'KL', 'LastName': 'Dawood', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Wayne State University, Detroit, MI, United States.'}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Nichols', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Nancy T', 'Initials': 'NT', 'LastName': 'Artinian', 'Affiliation': 'College of Nursing, Wayne State University, Detroit, MI, United States.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Schwiebert', 'Affiliation': 'College of Engineering, Wayne State University, Detroit, MI, United States.'}, {'ForeName': 'Hossein N', 'Initials': 'HN', 'LastName': 'Yarandi', 'Affiliation': 'College of Nursing, Wayne State University, Detroit, MI, United States.'}, {'ForeName': 'Dana N', 'Initials': 'DN', 'LastName': 'Roberson', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Plegue', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'LynnMarie C', 'Initials': 'LC', 'LastName': 'Mango', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Wayne State University, Detroit, MI, United States.'}, {'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Levy', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Wayne State University, Detroit, MI, United States.'}]",JMIR mHealth and uHealth,['10.2196/mhealth.6630']
1809,28217058,Sub-Tenon's injection versus paracetamol in pediatric strabismus surgery.,"BACKGROUND
Emergence agitation, vomiting, and oculocardiac reflex (OCR) in children undergoing strabismus surgery under general anesthesia are common problems. The purpose of this study was to determine whether the effect of analgesia can reduce the incidence of these problems. We compared the effects of sub-Tenon's injection versus intravenous (IV) and rectal paracetamol in this surgery.
METHODS
In a prospective, randomized, double-blind study, ninety patients ranging in age from 4 to 8 years scheduled for extraocular muscle surgery for strabismus were included in this study. After induction of anesthesia, just before the surgery, children were divided into three groups ( n = 30 for each group) Group A received sub-Tenon's anesthesia with 2.5% bupivacaine (0.08 ml/kg). Group B received IV paracetamol (20 mg/kg). Group C received paracetamol rectal suppository (40 mg/kg). The occurrence of oculocardiac reflex (OCR) intraoperatively was recorded. Then, in the Postanesthesia Care Unit, patients were assessed for their emergence behaviors. Vomiting was also noticed.
RESULTS
The OCR developed in few patients, and there was no significant difference between the groups. The highest number of patients with agitation was in Group C followed by Group B then Group A. Vomiting was significantly low in Group A followed by Group B then Group C.
CONCLUSION
Sub-Tenon block in strabismus surgery in children decreased the incidence of postoperative agitation and vomiting compared with IV paracetamol then rectal paracetamol. There was no difference between sub-Tenon block and paracetamol in the incidence of oculocardiac reflex.",2017,There was no difference between sub-Tenon block and paracetamol in the incidence of oculocardiac reflex.,"['children undergoing strabismus surgery under general anesthesia', 'pediatric strabismus surgery', 'ninety patients ranging in age from 4 to 8 years scheduled for extraocular muscle surgery for strabismus were included in this study']","['IV paracetamol', 'paracetamol rectal suppository', ""Sub-Tenon's injection versus paracetamol"", ""sub-Tenon's anesthesia with 2.5% bupivacaine"", 'paracetamol', ""sub-Tenon's injection versus intravenous (IV) and rectal paracetamol""]","['occurrence of oculocardiac reflex (OCR', 'postoperative agitation and vomiting', 'oculocardiac reflex', 'OCR', 'Vomiting', 'vomiting, and oculocardiac reflex (OCR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1705868', 'cui_str': 'Strabismus surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0028863', 'cui_str': 'Extraocular Muscles'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038379', 'cui_str': 'Phorias'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0991547', 'cui_str': 'Rectal Suppository'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0034938', 'cui_str': 'Reflex, Oculocardiac'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",90.0,0.209167,There was no difference between sub-Tenon block and paracetamol in the incidence of oculocardiac reflex.,"[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Shabana', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197349']
1810,28217059,Ultrasound-guided axillary brachial plexus block versus local infiltration anesthesia for arteriovenous fistula creation at the forearm for hemodialysis in patients with chronic renal failure.,"BACKGROUND
The primary failure rate for arteriovenous fistula (AVF) creation under local anesthesia for hemodialysis is about 30%. Axillary brachial plexus block (BPB) may improve blood flow through blood vessels used in fistula creation; it may improve the AVF blood flow and thus may reduce the primary failure rate after 3 months.
METHODS
Hundred and forty patients with chronic renal failure scheduled for AVF creation for hemodialysis were divided into two equal groups; Group 1 (AxBP-G) received ultrasound (US) guided axillary BPB, and Group 2 (LI-G) received local infiltration. We recorded the measurements of the brachial and radial arteries before and after anesthesia and the AVF blood flow in both groups at three different time points. Furthermore, the primary failure rate was recorded in each group and compared.
RESULTS
After anesthesia, the mean radial artery blood flow in the AxBP-group was 3.52 ml/min more than the LI-group, and the brachial artery diameter was also 0.68 mm more than in the LI-group, both differences were statistically significant ( P < 0.05). There were significant increases ( P < 0.05) in the AVF blood flow in the AxBP-group more than the LI-group with mean differences of 29.6, 69.8, and 27.2 ml/min at 4 h, 1 week, and 3 months, respectively. The overall mean of AVF blood flow was 42.21 ml/min more in the AxBP group than the LI-group a difference which is statistically significant ( P < 0.001). The primary failure rate was 17% in the AxBP group versus 30% in the LI-group; however, this difference is not significant statistically ( P = 0.110).
CONCLUSION
The US-guided axillary block increases AVF blood flow significantly more than local infiltration and nonsignificantly decreases the primary failure rate of the AVF after 3 months.",2017,"There were significant increases ( P < 0.05) in the AVF blood flow in the AxBP-group more than the LI-group with mean differences of 29.6, 69.8, and 27.2 ml/min at 4 h, 1 week, and 3 months, respectively.","['Hundred and forty patients with chronic renal failure scheduled for AVF creation for hemodialysis', 'patients with chronic renal failure']","['ultrasound (US) guided axillary BPB, and Group 2 (LI-G) received local infiltration', 'Ultrasound-guided axillary brachial plexus block versus local infiltration anesthesia', 'AxBP', 'arteriovenous fistula (AVF) creation under local anesthesia', 'Axillary brachial plexus block (BPB']","['primary failure rate', 'brachial artery diameter', 'mean radial artery blood flow', 'overall mean of AVF blood flow', 'AVF blood flow']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C1608675', 'cui_str': '4-iodo-N-(4-(4-(2-methoxyphenyl)-piperazin-1-yl)butyl)-benzamide'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0394701', 'cui_str': 'Brachial plexus block by axillary approach (procedure)'}, {'cui': 'C0234945', 'cui_str': 'Anesthesia, Infiltration'}, {'cui': 'C0398221', 'cui_str': 'Arteriovenous fistulization (procedure)'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}]",40.0,0.0315441,"There were significant increases ( P < 0.05) in the AVF blood flow in the AxBP-group more than the LI-group with mean differences of 29.6, 69.8, and 27.2 ml/min at 4 h, 1 week, and 3 months, respectively.","[{'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Nofal', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'El Fawal', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Shoukry', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Eas', 'Initials': 'E', 'LastName': 'Sabek', 'Affiliation': 'Department of Radio-diagnosis, National Centre of Radiation Research and Technology, Atomic Energy Authority, Cairo, Egypt.'}, {'ForeName': 'Wfa', 'Initials': 'W', 'LastName': 'Malak', 'Affiliation': 'Department of Vascular Surgery, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197355']
1811,30835152,"Adjunctive tianeptine treatment for bipolar disorder: A 24-week randomized, placebo-controlled, maintenance trial.","OBJECTIVE
The purpose of this study was to assess the efficacy and tolerability of tianeptine as an adjunctive maintenance treatment for bipolar depression.
METHODS
This is a multicenter double-blind randomized placebo-controlled maintenance trial of adjunctive tianeptine 37.5 mg/day. Participants ( n=161) had a Montgomery-Asberg Depression Rating Scale ⩾12 at entry. After eight weeks of open-label tianeptine treatment, those who responded to tianeptine ( n=69) were randomized to adjunctive tianeptine ( n=36) or placebo ( n=33) in addition to usual treatment. Kaplan-Meier estimates and the Mantel-Cox log-rank test were used to evaluate differences in time to intervention for a mood episode between the tianeptine and placebo groups. We also assessed overall functioning, biological rhythms, quality of life, rates of manic switch and serum brain-derived neurotrophic factor levels.
RESULTS
There were no differences between adjunctive tianeptine or placebo regarding time to intervention or depression scores in the 24-week double-blind controlled phase. Patients in the tianeptine group showed better performance in the letter-number sequencing subtest from the Wechsler Adult Intelligence Scale at the endpoint ( p=0.014). Tianeptine was well tolerated and not associated with higher risk for manic switch compared to placebo.
CONCLUSION
Tianeptine was not more effective than placebo in the maintenance treatment of bipolar depression. There is preliminary evidence suggesting a pro-cognitive effect of tianeptine in working memory compared to placebo.",2019,There were no differences between adjunctive tianeptine or placebo regarding time to intervention or depression scores in the 24-week double-blind controlled phase.,"['bipolar disorder', 'Participants ( n=161) had a Montgomery-Asberg Depression Rating Scale ⩾12 at entry']","['Tianeptine', 'placebo', 'Adjunctive tianeptine treatment', 'adjunctive tianeptine', 'tianeptine']","['depression scores', 'overall functioning, biological rhythms, quality of life, rates of manic switch and serum brain-derived neurotrophic factor levels', 'letter-number sequencing subtest', 'efficacy and tolerability']","[{'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]","[{'cui': 'C0076652', 'cui_str': 'tianeptine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031084', 'cui_str': 'Rhythmicity'}, {'cui': 'C0034380'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.430856,There were no differences between adjunctive tianeptine or placebo regarding time to intervention or depression scores in the 24-week double-blind controlled phase.,"[{'ForeName': 'Márcia', 'Initials': 'M', 'LastName': ""Kauer-Sant'Anna"", 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Benicio N', 'Initials': 'BN', 'LastName': 'Frey', 'Affiliation': ""3 Women's Health Concerns Clinic, St Joseph's Healthcare, Hamilton, ON, Canada.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Fijtman', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Loredo-Souza', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Aroldo A', 'Initials': 'AA', 'LastName': 'Dargél', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Pfaffenseller', 'Affiliation': '4 Mood Disorders Program, Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Wollenhaupt-Aguiar', 'Affiliation': '4 Mood Disorders Program, Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Fernando K', 'Initials': 'FK', 'LastName': 'Gazalle', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Gabriela D', 'Initials': 'GD', 'LastName': 'Colpo', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Ives C', 'Initials': 'IC', 'LastName': 'Passos', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Bücker', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Júlio C', 'Initials': 'JC', 'LastName': 'Walz', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jansen', 'Affiliation': '6 Department of Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Mendes', 'Initials': 'KM', 'LastName': 'Ceresér', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Kelen P', 'Initials': 'KP', 'LastName': 'Bürke Bridi', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Lisiane', 'Initials': 'L', 'LastName': 'Dos Santos Sória', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Kunz', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Pinho', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Natália S', 'Initials': 'NS', 'LastName': 'Kapczinski', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Pedro D', 'Initials': 'PD', 'LastName': 'Goi', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Pedro Vs', 'Initials': 'PV', 'LastName': 'Magalhães', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Reckziegel', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Renan K', 'Initials': 'RK', 'LastName': 'Burque', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Taiane', 'Initials': 'T', 'LastName': 'de Azevedo Cardoso', 'Affiliation': '4 Mood Disorders Program, Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'Kapczinski', 'Affiliation': '1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119826602']
1812,28217045,A comparative study on the efficacy of dexmedetomidine and tramadol on post-spinal anesthesia shivering.,"BACKGROUND
Shivering is a common postanesthesia adverse event with multiple etiologies. At present tramadol is a widely used drug for the control of shivering. However, tramadol may cause a lot of nausea and vomiting. Hence, the need to find a better drug with less of side effects. The aim of this study was to compare the efficacy of dexmedetomidine and tramadol in the treatment of post-spinal anesthesia (SA) shivering as well as to compare their side-effect profile.
MATERIALS AND METHODS
This prospective, double-blind, randomized controlled trial was conducted in a tertiary care hospital. A total of 100 patients having shivering after SA were enrolled, out of which fifty received dexmedetomidine (Group A) and 50 received tramadol (Group B). The response rate, time to cessation of shivering and side effects (if any) was noted. All the results were analyzed using Student's t -test and Chi-square test.
RESULTS
All patients who received dexmedetomidine as well as tramadol had cessation of shivering. The time to cessation of shivering was significantly less with dexmedetomidine (174.12 ± 14.366 s) than with tramadol (277.06 ± 23.374 s) ( P < 0.001). The recurrence rate of shivering with dexmedetomidine was less (6%) as compared to tramadol (16%). Nausea and vomiting was found to be higher in the case of tramadol. On the other hand, dexmedetomidine caused moderate sedation (modified Ramsay sedation score = 3-4) from which the patient could be easily awoken up.
CONCLUSION
Dexmedetomidine offers better results than tramadol with fewer side effects.",2017,The recurrence rate of shivering with dexmedetomidine was less (6%) as compared to tramadol (16%).,"['100 patients having shivering after SA', 'post-spinal anesthesia shivering']","['dexmedetomidine', 'Dexmedetomidine', 'dexmedetomidine and tramadol', 'tramadol']","['nausea and vomiting', 'recurrence rate of shivering', 'side effects', 'response rate, time to cessation of shivering and side effects', 'cessation of shivering', 'Nausea and vomiting', 'moderate sedation', 'time to cessation of shivering']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}]",100.0,0.0928307,The recurrence rate of shivering with dexmedetomidine was less (6%) as compared to tramadol (16%).,"[{'ForeName': 'Tanveer Singh', 'Initials': 'TS', 'LastName': 'Kundra', 'Affiliation': 'Department of Anaesthesia, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru, Karnataka, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Kuthiala', 'Affiliation': 'Department of Anaesthesia and Critical Care, SPS Hospitals, Ludhiana, Punjab, India.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Shrivastava', 'Affiliation': 'Department of Anaesthesia and Critical Care, SPS Hospitals, Ludhiana, Punjab, India.'}, {'ForeName': 'Parminder', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesia, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru, Karnataka, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197344']
1813,28217046,Effect of nebulized budesonide on respiratory mechanics and oxygenation in acute lung injury/acute respiratory distress syndrome: Randomized controlled study.,"BACKGROUND
We tested the hypothesis that nebulized budesonide would improve lung mechanics and oxygenation in patients with early acute lung injury (ALI) and/or acute respiratory distress syndrome (ARDS) during protective mechanical ventilation strategy without adversely affecting systemic hemodynamics.
METHODS
Patients with ALI/ARDS were included and assigned into two groups; budesonide group (30 cases) in whom 1 mg-2 ml budesonide suspension was nebulized through the endotracheal tube and control group (30 cases) in whom 2 ml saline (placebo) were nebulized instead of budesonide. This regimen was repeated every 12 h for three successive days alongside with constant ventilator settings in both groups. Hemodynamics, airway pressures, and PaO 2 /FiO 2 were measured throughout the study period (72 h) with either nebulized budesonide or saline. Furthermore, tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6) were analyzed serologically as markers of inflammation at pre- and post-nebulization sessions.
RESULTS
We found a significant difference between the two groups regarding PaO 2 /FiO 2 ( P = 0.023), peak ( P = 0.021), and plateau ( P = 0.032) airway pressures. Furthermore, TNF-α, IL-1β, and IL-6 were significantly reduced after budesonide nebulizations. No significant difference was found between the two groups regarding hemodynamic variables.
CONCLUSION
Nebulized budesonide improved oxygenation, peak, and plateau airway pressures and significantly reduced inflammatory markers (TNF-α, IL-1β and IL-6) without affecting hemodynamics.
TRIAL REGISTRY
Australian New Zealand Clinical Trial Registry (ANZCTR) at the number: ACTRN12615000373572.",2017,"Furthermore, TNF-α, IL-1β, and IL-6 were significantly reduced after budesonide nebulizations.","['group (30 cases) in whom 1 mg-2', 'Patients with ALI/ARDS', 'patients with early acute lung injury (ALI) and/or acute respiratory distress syndrome (ARDS', 'acute lung injury/acute respiratory distress syndrome']","['saline (placebo', 'ml budesonide suspension', 'Nebulized budesonide', 'nebulized budesonide', 'budesonide', 'nebulized budesonide or saline']","['Furthermore, tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6', 'oxygenation, peak, and plateau airway pressures', 'lung mechanics and oxygenation', 'inflammatory markers (TNF-α, IL-1β and IL-6', 'Hemodynamics, airway pressures, and PaO 2 /FiO 2', 'respiratory mechanics and oxygenation', 'Furthermore, TNF-α, IL-1β, and IL-6']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0242488', 'cui_str': 'Acute Lung Injury'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021753', 'cui_str': 'Catabolin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}]",,0.329315,"Furthermore, TNF-α, IL-1β, and IL-6 were significantly reduced after budesonide nebulizations.","[{'ForeName': 'Hatem Saber', 'Initials': 'HS', 'LastName': 'Mohamed', 'Affiliation': 'Department of Anesthesia and Intensive Care Unit, Faculty of Medicine, Qena University Hospital, South Valley University, Qena, Egypt.'}, {'ForeName': 'Mona Mohamed Abdel', 'Initials': 'MM', 'LastName': 'Meguid', 'Affiliation': 'Department of Clinical Pathology, Qena University Hospital, South Valley University, Qena, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197369']
1814,28217049,"Effectiveness of sodium thiopentone, propofol, and etomidate as an ideal intravenous anesthetic agent for modified electroconvulsive therapy.","INTRODUCTION
Electroconvulsive therapy (ECT) is a well-established psychiatric treatment in which seizures are electrically induced in patients for therapeutic effects. ECT can produce severe disturbances in the cardiovascular system and a marked increase in cerebral blood flow and intracranial pressure. These cardiovascular changes may be altered using various anesthetic drugs.
AIM AND OBJECTIVES
This study was undertaken to compare the effects of intravenous (IV) sodium thiopentone, propofol, and etomidate, used as IV anesthetic agents in modified ECT as regards, induction time and quality of anesthesia, alteration of hemodynamics, seizure duration, and recovery time.
MATERIALS AND METHODS
A total of 90 patients in the age group of 16-60 years of either sex, who had to undergo ECT therapy were divided randomly into three equal groups. Group A received propofol 1% - 1.5 mg/Kg, Group B received etomidate - 0.2 mg/Kg, and Group C received thiopentone 2.5% - 5 mg/Kg. All the patients were monitored for changes in heart rate, systolic blood pressure, diastolic blood pressure, and oxygen saturation at basal, after induction and 1 min, 2 min, 3 min, 5 min, 10 min, 20 min, and 30 min following ECT. Quality of anesthesia, seizure duration, and recovery times were also recorded.
CONCLUSION
We found that propofol had the advantage of smooth induction, stable hemodynamic parameters and rapid recovery as compared to etomidate and thiopentone. Thiopentone had the advantage over propofol of having longer seizure duration at the cost of a relatively prolonged recovery period. Etomidate had a definite advantage of longer seizure duration.",2017,"We found that propofol had the advantage of smooth induction, stable hemodynamic parameters and rapid recovery as compared to etomidate and thiopentone.","['90 patients in the age group of 16-60 years of either sex, who had to undergo ECT therapy']","['intravenous (IV) sodium thiopentone, propofol, and etomidate', 'Thiopentone', 'Electroconvulsive therapy (ECT', 'ECT', 'Etomidate', 'etomidate - 0.2 mg/Kg', 'thiopentone', 'propofol', 'thiopentone 2.5% - 5 mg/Kg', 'sodium thiopentone, propofol, and etomidate']","['Quality of anesthesia, seizure duration, and recovery times', 'heart rate, systolic blood pressure, diastolic blood pressure, and oxygen saturation', 'definite advantage of longer seizure duration', 'induction time and quality of anesthesia, alteration of hemodynamics, seizure duration, and recovery time', 'cerebral blood flow and intracranial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}]",90.0,0.0146731,"We found that propofol had the advantage of smooth induction, stable hemodynamic parameters and rapid recovery as compared to etomidate and thiopentone.","[{'ForeName': 'Altaf Hussain', 'Initials': 'AH', 'LastName': 'Mir', 'Affiliation': 'Department of Anaesthesiology, Government Medical College, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Nida Farooq', 'Initials': 'NF', 'LastName': 'Shah', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Mehraj Ud', 'Initials': 'MU', 'LastName': 'Din', 'Affiliation': 'Department of Anaesthesiology, Government Medical College, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Shabir Ahmad', 'Initials': 'SA', 'LastName': 'Langoo', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Fayaz Ahmad', 'Initials': 'FA', 'LastName': 'Reshi', 'Affiliation': 'Department of Anaesthesiology, Government Medical College, Srinagar, Jammu and Kashmir, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197339']
1815,28217050,Acoustic puncture assist device™ versus conventional loss of resistance technique for thoracic paravertebral space identification: Clinical and ultrasound evaluation.,"BACKGROUND
Acoustic puncture assist device (APAD™) is a pressure measurement combined with a related acoustic signal that has been successfully used to facilitate epidural punctures. The principal of loss of resistance (LOR) is similar when performing paravertebral block (PVB). We investigated the usefulness of APAD™ by comparing it with the conventional LOR techniques for identifying paravertebral space (PVS).
SUBJECTS AND METHODS
A total of 100 women who were scheduled for elective breast surgery under general anesthesia with PVB were randomized into two equal groups. The first group (APAD group) was scheduled for PVB using APAD™. The second group (C group) was scheduled for PVB using conventional LOR technique. We recorded the success rate assessed by clinical and ultrasound findings, the time required to identify the PVS, the depth of the PVS and the number of attempts. The attending anesthesiologist was also questioned about the usefulness of the acoustic signal for detection of the PVS.
RESULTS
The incidence of successful PVB was (49) in APAD group compared to (42) in C group P < 0.05. The time required to do PVB was significantly shorter in APAD group than in C group (3.5 ± 1.35 vs. 4.1 ± 1.42) minutes. Two patients in APAD group needed two or more attempts compared to four patients in C group. The attending anesthesiologist found the acoustic signal valuable in all patients in APAD group.
CONCLUSION
Using APAD™ compared to the conventional LOR technique showed a lower failure rate and a shorter time to identify the PVS.",2017,The incidence of successful PVB was (49) in APAD group compared to (42) in C group P < 0.05.,['100 women who were scheduled for elective breast surgery under general anesthesia with PVB'],"['conventional LOR techniques', 'Acoustic puncture assist device™ versus conventional loss of resistance technique', 'Acoustic puncture assist device (APAD™', 'conventional LOR technique']","['loss of resistance (LOR', 'time required to do PVB', 'incidence of successful PVB', 'failure rate']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0587268', 'cui_str': 'Loss of resistance technique (qualifier value)'}, {'cui': 'C0047196', 'cui_str': 'APADH'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",100.0,0.0265178,The incidence of successful PVB was (49) in APAD group compared to (42) in C group P < 0.05.,"[{'ForeName': 'Monaz Abdulrahman', 'Initials': 'MA', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Ashraf Abualhasan', 'Initials': 'AA', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197368']
1816,32492148,"The Type and Amount of Dietary Fat Affect Plasma Factor VIIc, Fibrinogen, and PAI-1 in Healthy Individuals and Individuals at High Cardiovascular Disease Risk: 2 Randomized Controlled Trials.","BACKGROUND
Factor VIIc, fibrinogen, and plasminogen activator inhibitor 1 (PAI-1) are cardiovascular disease (CVD) risk factors and are modulated, in part, by fat type and amount.
OBJECTIVE
We evaluated fat type and amount on the primary outcomes: factor VIIc, fibrinogen, and PAI-1.
METHODS
In the Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA) Trial, 2 controlled crossover feeding studies evaluated substituting carbohydrate or MUFAs for SFAs. Study 1: healthy participants (n = 103) were provided with (8 wk) an average American diet [AAD; designed to provide 37% of energy (%E) as fat, 16% SFA], a Step 1 diet (30%E fat, 9% SFA), and a diet low in SFA (Low-Sat; 26%E fat, 5% SFA). Study 2: participants (n = 85) at risk for CVD and metabolic syndrome (MetSyn) were provided with (7 wk) an AAD, a step 1 diet, and a high-MUFA diet (designed to provide 37%E fat, 8% SFA, 22% MUFA).
RESULTS
Study 1: compared with AAD, the Step 1 and Low-Sat diets decreased mean factor VIIc by 1.8% and 2.6% (overall P = 0.0001), increased mean fibrinogen by 1.2% and 2.8% (P = 0.0141), and increased mean square root PAI-1 by 0.0% and 6.0% (P = 0.0037), respectively. Study 2: compared with AAD, the Step 1 and high-MUFA diets decreased mean factor VIIc by 4.1% and 3.2% (overall P < 0.0001), increased mean fibrinogen by 3.9% and 1.5% (P = 0.0083), and increased mean square-root PAI-1 by 2.0% and 5.8% (P = 0.1319), respectively.
CONCLUSIONS
Replacing SFA with carbohydrate decreased factor VIIc and increased fibrinogen in healthy and metabolically unhealthy individuals and also increased PAI-1 in healthy subjects. Replacing SFA with MUFA decreased factor VIIc and increased fibrinogen but less than carbohydrate. Our results indicate an uncertain effect of replacing SFA with carbohydrate or MUFA on cardiometabolic risk because of small changes in hemostatic factors and directionally different responses to decreasing SFA. This trial was registered at https://clinicaltrials.gov/ct2/show/NCT00000538?term=NCT00000538&rank=1 as NCT00000538.",2020,"CONCLUSIONS
Replacing SFA with carbohydrate decreased factor VIIc and increased fibrinogen in healthy and metabolically unhealthy individuals and also increased PAI-1 in healthy subjects.","['Healthy Individuals and Individuals at High Cardiovascular Disease Risk', 'Study 1: healthy participants (n\xa0=\xa0103', 'healthy subjects', 'Study 2: participants (n\xa0=\xa085) at risk for']",['carbohydrate or MUFAs'],"['mean square-root PAI-1', 'mean fibrinogen', 'factor\xa0VIIc and increased fibrinogen', 'CVD and metabolic syndrome (MetSyn', 'mean factor VIIc', 'mean square root PAI-1', 'factor VIIc, fibrinogen, and PAI-1', 'Lipoproteins and Thrombogenic Activity (DELTA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",103.0,0.0521474,"CONCLUSIONS
Replacing SFA with carbohydrate decreased factor VIIc and increased fibrinogen in healthy and metabolically unhealthy individuals and also increased PAI-1 in healthy subjects.","[{'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Stewart', 'Affiliation': 'Department of Biostatistics, Collaborative Studies Coordinating Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Colchester Research Facility, University of Vermont, Colchester, VT, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lefevre', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Elmer', 'Affiliation': 'Division of Epidemiology, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Berglund', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Abby G', 'Initials': 'AG', 'LastName': 'Ershow', 'Affiliation': 'Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Pearson', 'Affiliation': 'The Mary Imogene Bassett Research Institute, Cooperstown, NY, USA.'}, {'ForeName': 'Rajasekhar', 'Initials': 'R', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Holleran', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Dennis', 'Affiliation': 'Department of Biostatistics, Collaborative Studies Coordinating Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Wahida', 'Initials': 'W', 'LastName': 'Karmally', 'Affiliation': 'Department of Medicine, Irving Center for Clinical Research, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa137']
1817,32492131,Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial.,"Importance
Two-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis seems to provide benefits in terms of postoperative morbidity compared with standard hand-sewn coloanal anastomosis associated with diverting ileostomy and further ileostomy reversal in patients operated on for low rectal cancer.
Objective
To compare 30-day postoperative and 1-year follow-up results of Turnbull-Cutait pull-through hand-sewn coloanal anastomosis and standard hand-sewn coloanal anastomosis after ultralow rectal resection for rectal cancer.
Design, Setting, and Participants
Multicenter randomized clinical trial. Neither patients nor surgeons were blinded for technique. Patients were recruited in 3 centers, Bellvitge University Hospital and Valle d'Hebron University Hospital in Spain and Instituto Nazionale Tumori Fondazione G. Pascale-Istituto di Ricovero e Cura a Carattere Scientifico in Italy. Patients undergoing ultralow anterior rectal resection needing hand-sewn coloanal anastomosis were randomly assigned to 2-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis or standard hand-sewn coloanal anastomosis associated with diverting ileostomy. Data were analyzed between June 2012 and October 2018.
Interventions
All patients underwent ultralow anterior resection. Patients assigned to the 2-stage Turnbull-Cutait pull-through group underwent exteriorization of a segment of left colon through the anal canal and, after 6 to 10 days, the exteriorized colon was resected and a delayed hand-sewn coloanal anastomosis was performed. For patients assigned to standard coloanal anastomosis, the hand-sewn coloanal anastomosis was performed with diverting ileostomy at first operation. Closure of the ileostomy was planned after 6 to 8 months.
Main Outcomes and Measures
Primary outcome was 30-day postoperative morbidity. For the standard hand-sewn coloanal anastomosis with diverting ileostomy group, overall postoperative morbidity includes 30-day postoperative complications of the ileostomy closure.
Results
Ninety-two white patients, 72 men and 20 women, with a median age of 62 years, were randomized and included in the analysis. Forty-six patients received standard hand-sewn coloanal anastomosis with diverting ileostomy and 46 received the 2-stage pull-through hand-sewn coloanal anastomosis. Seven patients (15.2%) in the standard hand-sewn coloanal anastomosis group did not undergo reversal ileostomy, and 1 patient (2.2%) in the 2-stage pull-through hand-sewn coloanal anastomosis group did not undergo delayed coloanal anastomosis. The 30-day overall composite postoperative complications rate was similar between the 2 groups (34.8% in 2-stage pull-through hand-sewn coloanal anastomosis group vs 45.7% in standard hand-sewn coloanal anastomosis group; P = .40), with a difference of -10.9 (95% CI, -29.5 to 8.9).
Conclusions and Relevance
The 2-stage pull-through hand-sewn coloanal anastomosis after ultralow anterior resection for low rectal cancer is safe and does not increase the postoperative morbidity rate compared with standard coloanal anastomosis with covering ileostomy followed by ileostomy closure.
Trial Registration
ClinicalTrials.gov Identifier: NCT01766661.",2020,"The 30-day overall composite postoperative complications rate was similar between the 2 groups (34.8% in 2-stage pull-through hand-sewn coloanal anastomosis group vs 45.7% in standard hand-sewn coloanal anastomosis group; P = .40), with a difference of -10.9 (95% CI, -29.5 to 8.9).
","['Patients undergoing ultralow anterior rectal resection needing hand-sewn coloanal anastomosis', 'Low Rectal Cancer', 'Ninety-two white patients, 72 men and 20 women, with a median age of 62 years', ""Patients were recruited in 3 centers, Bellvitge University Hospital and Valle d'Hebron University Hospital in Spain and Instituto Nazionale Tumori Fondazione G. Pascale-Istituto di Ricovero""]","['standard coloanal anastomosis, the hand-sewn coloanal anastomosis was performed with diverting ileostomy at first operation', 'Turnbull-Cutait pull-through hand-sewn coloanal anastomosis and standard hand-sewn coloanal anastomosis after ultralow rectal resection', '2-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis or standard hand-sewn coloanal anastomosis associated with diverting ileostomy', 'standard hand-sewn coloanal anastomosis with diverting ileostomy and 46 received the 2-stage pull-through hand-sewn coloanal anastomosis', 'ultralow anterior resection', '2-stage Turnbull-Cutait pull-through group underwent exteriorization of a segment of left colon through the anal canal', 'Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis']","['30-day postoperative morbidity', '30-day overall composite postoperative complications rate', 'postoperative morbidity rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185000', 'cui_str': 'Exteriorization - action'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0227388', 'cui_str': 'Left colon structure'}, {'cui': 'C0227411', 'cui_str': 'Anal canal structure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",92.0,0.128528,"The 30-day overall composite postoperative complications rate was similar between the 2 groups (34.8% in 2-stage pull-through hand-sewn coloanal anastomosis group vs 45.7% in standard hand-sewn coloanal anastomosis group; P = .40), with a difference of -10.9 (95% CI, -29.5 to 8.9).
","[{'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Biondo', 'Affiliation': 'Colorectal Unit, IDIBELL, Bellvitge University Hospital, Department of General and Digestive Surgery, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Trenti', 'Affiliation': 'Colorectal Unit, IDIBELL, Bellvitge University Hospital, Department of General and Digestive Surgery, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Espin', 'Affiliation': ""Colorectal Unit, Vall d'Hebron University Hospital, Department of General and Digestive Surgery, Autonomic University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bianco', 'Affiliation': 'General and Colorectal Surgery Unit, S. Leonardo Hospital/ASL-Na3-sud, Castellammare di Stabia, Naples, Italy.'}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Barrios', 'Affiliation': 'Colorectal Unit, IDIBELL, Bellvitge University Hospital, Department of General and Digestive Surgery, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Falato', 'Affiliation': 'General Surgery Unit, S. Giuliano Hospital, Giugliano, Naples, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'De Franciscis', 'Affiliation': 'Colorectal Cancer Surgery Unit, Istituto Nazionale Tumori di Napoli, Istituto di Ricovero e Cura a Carattere Scientifico, Naples, Italy.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Solis', 'Affiliation': ""Colorectal Unit, Vall d'Hebron University Hospital, Department of General and Digestive Surgery, Autonomic University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kreisler', 'Affiliation': 'Colorectal Unit, IDIBELL, Bellvitge University Hospital, Department of General and Digestive Surgery, University of Barcelona, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.1625']
1818,28217051,Comparison of intrathecal clonidine and fentanyl in hyperbaric bupivacaine for spinal anesthesia and postoperative analgesia in patients undergoing lower abdominal surgeries.,"BACKGROUND
There are many adjuvant used along with bupivacaine for subarachnoid block, but fentanyl and clonidine are commonly used as adjuvant to intrathecal bupivacaine for prolonging both sensory and motor blockade as well as postoperative analgesia in patients undergoing lower abdominal surgeries.
OBJECTIVE
There is a paucity of studies comparing the efficacy of fentanyl and clonidine as adjuvant to intrathecal bupivacaine for improving intraoperative effect and postoperative analgesia in lower abdominal surgeries instigated us compare the effect of these drugs.
METHODS
This prospective, randomized study is conducted on 100 American Society of Anesthesiologists I or II patients between 18 and 65 years of age divided into two groups of 50 each. The patients were given 2.5 ml of 0.5% hyperbaric bupivacaine with either 50 μg of clonidine (BC Group) or 25 μg of fentanyl (BF Group) intrathecally. The onset and duration of sensory and motor block, sedation score, hemodynamic parameters, total analgesia time, and potential side effects were recorded and compared.
RESULTS
Both the groups were comparable in demographic data, onset and duration of sensory and motor blockade, hemodynamic parameters, but the duration of analgesia is significantly longer in clonidine group when compared with fentanyl group. Sedation score is more in clonidine group.
CONCLUSION
Addition of clonidine to intrathecal bupivacaine offers longer duration of postoperative analgesia than fentanyl but with higher sedation.",2017,"Both the groups were comparable in demographic data, onset and duration of sensory and motor blockade, hemodynamic parameters, but the duration of analgesia is significantly longer in clonidine group when compared with fentanyl group.","['patients undergoing lower abdominal surgeries', '100 American Society of Anesthesiologists I or II patients between 18 and 65 years of age divided into two groups of 50 each']","['bupivacaine', 'hyperbaric bupivacaine', 'clonidine', 'clonidine (BC Group) or 25 μg of fentanyl (BF Group) intrathecally', 'intrathecal clonidine and fentanyl']","['Sedation score', 'duration of analgesia', 'duration of postoperative analgesia', 'onset and duration of sensory and motor block, sedation score, hemodynamic parameters, total analgesia time, and potential side effects', 'demographic data, onset and duration of sensory and motor blockade, hemodynamic parameters', 'spinal anesthesia and postoperative analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]",100.0,0.0701458,"Both the groups were comparable in demographic data, onset and duration of sensory and motor blockade, hemodynamic parameters, but the duration of analgesia is significantly longer in clonidine group when compared with fentanyl group.","[{'ForeName': 'Baljit Singh', 'Initials': 'BS', 'LastName': 'Bajwa', 'Affiliation': 'Department of Anesthesia, PIMS Medical College, Jalandhar, Punjab, India.'}, {'ForeName': 'Arwinder Pal', 'Initials': 'AP', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesia, PIMS Medical College, Jalandhar, Punjab, India.'}, {'ForeName': 'Angelina K', 'Initials': 'AK', 'LastName': 'Rekhi', 'Affiliation': 'Department of Anesthesia, PIMS Medical College, Jalandhar, Punjab, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197337']
1819,32492138,No effect of resveratrol supplementation after 6 months on insulin sensitivity in overweight adults: a randomized trial.,"BACKGROUND
Effects of resveratrol on metabolic health have been studied in several short-term human clinical trials, with conflicting results. Next to dose, the duration of the clinical trials may explain the lack of effect in some studies, but long-term studies are still limited.
OBJECTIVES
The objective of this study was to investigate the effects of 6-mo resveratrol supplementation on metabolic health outcome parameters.
METHODS
Forty-one overweight men and women (BMI: 27-35 kg/m2; aged 40-70 y) completed the study. In this parallel-group, double-blind clinical trial, participants were randomized to receive either 150 mg/d of resveratrol (n = 20) or placebo (n = 21) for 6 mo. The primary outcome of the study was insulin sensitivity, using the Matsuda index. Secondary outcome measures were intrahepatic lipid (IHL) content, body composition, resting energy metabolism, blood pressure, plasma markers, physical performance, quality of life, and quality of sleep. Postintervention differences between the resveratrol and placebo arms were evaluated by ANCOVA adjusting for corresponding preintervention variables.
RESULTS
Preintervention, no differences were observed between the 2 treatment arms. Insulin sensitivity was not affected after 6 mo of resveratrol treatment (adjusted mean Matsuda index: 5.18 ± 0.35 in the resveratrol arm compared with 5.50 ± 0.34 in the placebo arm), although there was a significant difference in postintervention glycated hemoglobin (HbA1c) between the arms (P = 0.007). The adjusted means showed that postintervention HbA1c was lower on resveratrol (35.8 ± 0.43 mmol/mol) compared with placebo (37.6 ± 0.44 mmol/mol). No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
CONCLUSIONS
After 6 mo of resveratrol supplementation, insulin sensitivity was unaffected in the resveratrol arm compared with the placebo arm. Nonetheless, HbA1c was lower in overweight men and women in the resveratrol arm. This trial was registered at Clinicaltrials.gov as NCT02565979.",2020,"No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
","['overweight adults', 'Forty-one overweight men and women', 'BMI: 27-35 kg/m2; aged 40-70 y) completed the study']","['6-mo resveratrol supplementation', 'placebo', 'resveratrol supplementation']","['insulin sensitivity, using the Matsuda index', 'metabolic health outcome parameters', 'postintervention glycated hemoglobin (HbA1c', 'postintervention HbA1c', 'insulin sensitivity', 'IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep', 'Insulin sensitivity', 'intrahepatic lipid (IHL) content, body composition, resting energy metabolism, blood pressure, plasma markers, physical performance, quality of life, and quality of sleep']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",41.0,0.562601,"No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
","[{'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'de Ligt', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Bergman', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Rodrigo Mancilla', 'Initials': 'RM', 'LastName': 'Fuentes', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Essers', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Moonen-Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa125']
1820,28216232,"Safety and efficacy of a Nav1.7 selective sodium channel blocker in patients with trigeminal neuralgia: a double-blind, placebo-controlled, randomised withdrawal phase 2a trial.","BACKGROUND
Current standard of care for trigeminal neuralgia is treatment with the sodium channel blockers carbamazepine and oxcarbazepine, which although effective are associated with poor tolerability and the need for titration. BIIB074, a Nav1.7-selective, state-dependent sodium-channel blocker, can be administered at therapeutic doses without titration, and has shown good tolerability in healthy individuals in phase 1 studies. We therefore assessed the safety and efficacy of BIIB074 in patients with trigeminal neuralgia in a phase 2a study.
METHODS
We did a double-blind, multicentre, placebo-controlled, randomised withdrawal phase 2a trial in 25 secondary care centres in Denmark, Estonia, France, Germany, Italy, Latvia, Lithuania, Romania, South Africa, Spain, Switzerland, and the UK. After a 7-day run-in phase, eligible patients aged 18-80 years with confirmed trigeminal neuralgia received open-label, BIIB074 150 mg three times per day, orally, for 21 days. Patients who met at least one response criteria were then randomly assigned (1:1) to BIIB074 or placebo for up to 28 days in a double-blind phase. We used an interactive web response system to assign patients with a computer-generated schedule, with stratification (presence or absence of existing pain medication). Patients, clinicians, and assessors were masked to treatment allocation. The primary endpoint was the difference between groups in the number of patients classified as treatment failure during the double blind phase assessed in the modified intention-to-treat population. We assessed safety in all patients who received one or more doses of BIIB074. This study is registered with ClinicalTrials.gov (NCT01540630) and EudraCT (2010-023963-16).
FINDINGS
The first patient was enrolled on April 23, 2012, and the last patient completed the study on February 26, 2014. We enrolled 67 patients into the open-label phase; 44 completed open-label treatment, and 29 were randomly assigned to double-blind treatment (15 to BIIB074 and 14 to placebo). During the double-blind phase, five (33%) patients assigned to BIIB074 versus nine (64%) assigned to placebo were classified as treatment failures (p=0·0974). BIIB074 was well tolerated, with similar adverse events in the double-blind phase to placebo. Headache was the most common adverse event with BIIB074 in the open-label phase (in 13 [19%] of 67 patients), followed by dizziness (in six [9%] patients). In the double-blind phase, headache, pyrexia, nasopharyngitis, sleep disorder, and tremor were the most frequent adverse events in patients assigned to BIIB074 (in one [7%] of 15 patients for each event), and headache, dizziness, diarrhoea, and vomiting were the most frequent adverse events in patients assigned to placebo (in one [7%] of 14 patients for each event). No severe or serious adverse events were reported in the BIIB074 group during the double-blind phase. One patient assigned to placebo reported intestinal adhesions with obstruction as a severe and serious adverse event, which was considered as unrelated to study medication.
INTERPRETATION
The primary endpoint of treatment failure was not significantly lower in the BIIB074 group than in the placebo group. However, our findings provide a basis for continued investigation of BIIB074 in patients with trigeminal neuralgia in future clinical trials.
FUNDING
Convergence Pharmaceuticals.",2017,No severe or serious adverse events were reported in the BIIB074 group during the double-blind phase.,"['patients with trigeminal neuralgia in future clinical trials', 'patients with trigeminal neuralgia in a phase 2a study', 'eligible patients aged 18-80 years with confirmed trigeminal neuralgia received', 'healthy individuals', 'The first patient was enrolled on April 23, 2012, and the last patient completed the study on February 26, 2014', 'patients who received one or more doses of BIIB074', 'Patients who met at least one response criteria', 'patients with trigeminal neuralgia', '67 patients into the open-label phase; 44 completed', '25 secondary care centres in Denmark, Estonia, France, Germany, Italy, Latvia, Lithuania, Romania, South Africa, Spain, Switzerland, and the UK']","['open-label', 'placebo', 'open-label treatment', 'EudraCT', 'sodium channel blockers carbamazepine and oxcarbazepine', 'Nav1.7 selective sodium channel blocker']","['safety and efficacy', 'intestinal adhesions', 'tolerated', 'modified intention-to-treat population', 'severe or serious adverse events', 'number of patients classified as treatment failure', 'headache, dizziness, diarrhoea, and vomiting', 'Headache', 'headache, pyrexia, nasopharyngitis, sleep disorder, and tremor', 'treatment failure', 'dizziness', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040997', 'cui_str': 'Fothergill Disease'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4505505', 'cui_str': 'BIIB074'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0014908', 'cui_str': 'Estonia'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0023128', 'cui_str': 'Republic of Latvia'}, {'cui': 'C0023879', 'cui_str': 'Lithuania'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037492', 'cui_str': 'Ion Channels, Sodium'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}, {'cui': 'C0872271', 'cui_str': 'Sodium Channel Inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0267778', 'cui_str': 'Adhesion of intestine (disorder)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0162643'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]",67.0,0.563476,No severe or serious adverse events were reported in the BIIB074 group during the double-blind phase.,"[{'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Zakrzewska', 'Affiliation': 'Facial Pain Unit, Division of Diagnostic, Surgical and Medical Sciences, Eastman Dental Hospital, University College London Hospitals NHS Foundation Trust/University College London, London, UK. Electronic address: j.zakrzewska@ucl.ac.uk.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Convergence Pharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Morisset', 'Affiliation': 'Convergence Pharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Gerard Mp', 'Initials': 'GM', 'LastName': 'Giblin', 'Affiliation': 'Convergence Pharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Obermann', 'Affiliation': 'Department of Neurology and German Headache Center, University of Duisburg-Essen, Essen, Germany; Center for Neurology, Asklepios Hospitals Schildautal, Seesen, Germany.'}, {'ForeName': 'Dominik A', 'Initials': 'DA', 'LastName': 'Ettlin', 'Affiliation': 'Interdisciplinary Orofacial Pain Unit, Clinic KFS-KAB, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cruccu', 'Affiliation': 'Department of Neurology and Psychiatry, Sapienza University, Roma, Italy.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bendtsen', 'Affiliation': 'Danish Headache Centre, Department of Neurology, Rigshospitalet-Glostrup, University of Copenhagen, Nordre Ringvej 67, 2600 Glostrup, Denmark.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Estacion', 'Affiliation': 'Department of Neurology and Center for Neuroscience and Regeneration Research, Yale University School of Medicine, and Veterans Affairs Medical Center, West Haven, CT, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Derjean', 'Affiliation': 'Convergence Pharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Waxman', 'Affiliation': 'Department of Neurology and Center for Neuroscience and Regeneration Research, Yale University School of Medicine, and Veterans Affairs Medical Center, West Haven, CT, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Layton', 'Affiliation': 'ParamStat, Ash, Canterbury, Kent, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gunn', 'Affiliation': 'Convergence Pharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tate', 'Affiliation': 'Convergence Pharmaceuticals, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(17)30005-4']
1821,28217076,"Lung ultrasound versus chest radiography for the diagnosis of pneumothorax in critically ill patients: A prospective, single-blind study.",,2017,,['critically ill patients'],['Lung ultrasound versus chest radiography'],[],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]",[],,0.0191752,,"[{'ForeName': 'Mahmood Dhahir', 'Initials': 'MD', 'LastName': 'Al-Mendalawi', 'Affiliation': 'Department of Paediatrics, Al-Kindy College of Medicine, Baghdad University, Baghdad, Iraq.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197360']
1822,28217052,Topical versus caudal ketamine/bupivacaine combination for postoperative analgesia in children undergoing inguinal herniotomy.,"BACKGROUND
Multiple studies claim that caudal administration of ketamine causes effective postoperative analgesia. The aim of this study was to assess the clinical effectiveness of ketamine after caudal or topical administration in pediatric patients undergoing inguinal herniotomy.
PATIENTS AND METHODS
This randomized, comparative, double-blind study included eighty children (aged 6 months to 6 years) received either 1 ml/kg of 0.25% bupivacaine/ketamine 0.5 mg/kg for caudal analgesia (caudal group) or 0.3 ml/kg of 0.25% bupivacaine/ketamine 0.5 mg/kg sprayed by the surgeon around the spermatic cord and upon the ilioinguinal nerve before wound closure for topical analgesia (topical group). The duration of postoperative analgesia, pain scores, rescue analgesic consumption, sedation score, hemodynamic monitoring, and side-effects were evaluated 48 h postoperative.
RESULTS
Kaplan-Meier survival analysis of analgesia free time demonstrated a significant advantage of topical ketamine (TK) group over caudal ketamine (CK) group. The duration of postoperative analgesia was longer in TK group than in CK group (28.74 ± 2.88 vs. 21.43 ± 5.01 h, P = 0.000). Fewer children asked for oral analgesics in the topical group (24 of 36, 66.7%) than in the caudal one (28 of 32, 87.5%; P < 0.01). Postoperative pain scores at the 6 th till 48 th h were lower in topical group with comparable analgesic consumption between two groups. In the caudal group, four subjects suffered from retention of urine: Two presented with a residual motor block and two had photophobia.
CONCLUSION
Wound instillation of bupivacaine/ketamine is a simple, noninvasive, and effective technique that could be a safe alternative to CK for postoperative analgesia in children undergoing inguinal hernia repair.",2017,Postoperative pain scores at the 6 th till 48 th h were lower in topical group with comparable analgesic consumption between two groups.,"['children undergoing inguinal hernia repair', 'eighty children (aged 6 months to 6 years', 'pediatric patients undergoing inguinal herniotomy', 'children undergoing inguinal herniotomy']","['ketamine (CK', 'ketamine', 'bupivacaine/ketamine', '1 ml/kg of 0.25% bupivacaine/ketamine 0.5 mg/kg for caudal analgesia (caudal group) or 0.3 ml/kg of 0.25% bupivacaine/ketamine 0.5 mg/kg sprayed by the surgeon around the spermatic cord and upon the ilioinguinal nerve before wound closure for topical analgesia (topical group', 'topical ketamine (TK', 'Topical versus caudal ketamine/bupivacaine combination']","['retention of urine', 'duration of postoperative analgesia, pain scores, rescue analgesic consumption, sedation score, hemodynamic monitoring, and side-effects', 'Postoperative pain scores', 'duration of postoperative analgesia', 'clinical effectiveness', 'photophobia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0405600', 'cui_str': 'Simple excision of inguinal hernial sac (procedure)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0037855', 'cui_str': 'Funiculus Spermaticus'}, {'cui': 'C0228906', 'cui_str': 'Structure of ilioinguinal nerve'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic Monitoring'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}]",80.0,0.277217,Postoperative pain scores at the 6 th till 48 th h were lower in topical group with comparable analgesic consumption between two groups.,"[{'ForeName': 'Hala Saad', 'Initials': 'HS', 'LastName': 'Abdel-Ghaffar', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Seham Mohamed', 'Initials': 'SM', 'LastName': 'Moeen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Moeen', 'Affiliation': 'Department of Urology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197338']
1823,28217054,Role of intercostal nerve block in reducing postoperative pain following video-assisted thoracoscopy: A randomized controlled trial.,"BACKGROUND
The main advantages of video assisted thoracoscopic surgery (VATS) include less post-operative pain, rapid recovery, less postoperative complications, shorter hospital stay and early discharge. Although pain intensity is less as compared to conventional thoracotomy but still patients experience upto moderate pain postoperatively. The objective of this study was to assess the efficacy and morphine sparing effect of intercostal nerve block in alleviating immediate post-operative pain in patients undergoing VATS.
MATERIALS AND METHODS
Sixty ASA I-III patients, aged between 16 to 60 years, undergoing mediastinal lymph node biopsy through VATS under general anaesthesia were randomly divided into two groups. The intercostal nerve block (ICNB group) received the block along with patient control intravenous analgesia (PCIA) with morphine, while control group received only PCIA with morphine for post-operative analgesia. Patients were followed for twenty four hours post operatively for intervention of post-operative pain in the recovery room and ward.
RESULTS
The pain was assessed using visual analogue scale (VAS) at 1, 6, 12 and 24 hours. There was a significant decrease in pain score and morphine consumption in ICNB group as compared to control group in first 6 hours postoperatively. There was no significant difference in pain scores and morphine consumption between the two groups after 6 hours.
CONCLUSION
Patients receiving intercostal nerve block have better pain control and less morphine consumption as compared to those patients who did not receive intercostal nerve block in early (6 hours) post-operative period.",2017,There was a significant decrease in pain score and morphine consumption in ICNB group as compared to control group in first 6 hours postoperatively.,"['patients undergoing VATS', 'Sixty ASA I-III patients, aged between 16 to 60 years, undergoing mediastinal lymph node biopsy through VATS under general anaesthesia']","['morphine, while control group received only PCIA with morphine', 'morphine', 'conventional thoracotomy', 'video-assisted thoracoscopy', 'video assisted thoracoscopic surgery (VATS', 'intercostal nerve block']","['postoperative pain', 'pain score and morphine consumption', 'pain', 'postoperative complications, shorter hospital stay and early discharge', 'pain scores and morphine consumption', 'pain intensity', 'pain control', 'visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node structure (body structure)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C2923055', 'cui_str': 'Video assisted thoracoscopy (procedure)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block (procedure)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.133801,There was a significant decrease in pain score and morphine consumption in ICNB group as compared to control group in first 6 hours postoperatively.,"[{'ForeName': 'Zulfiqar', 'Initials': 'Z', 'LastName': 'Ahmed', 'Affiliation': 'Department of Anaesthesiology, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Samad', 'Affiliation': 'Department of Anaesthesiology, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Hameed', 'Initials': 'H', 'LastName': 'Ullah', 'Affiliation': 'Department of Anaesthesiology, Aga Khan University, Karachi, Pakistan.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197342']
1824,28217055,Ultrasound-guided transversus abdominis plane block: What are the benefits of adding dexmedetomidine to ropivacaine?,"BACKGROUND
Ultrasound-guided transversus abdominis plane (TAP) block has recently come up as a modality to take care of postoperative pain. It can somewhat avoid the use of intravenous opioid analgesics and hence to avoid its complications. We have performed a prospective, double-blinded, randomized study to assess the analgesic effect of adding dexmedetomidine to local ropivacaine on TAP block for patients undergoing lower abdominal surgeries.
AIM
The aim is to assess whether addition of dexmedetomidine to ropivacaine may bring some improvements to the analgesic efficacy of TAP blocks in patients undergoing lower abdominal surgeries.
MATERIALS AND METHODS
The study was conducted on forty patients undergoing lower abdominal surgeries under general anesthesia. The patients were divided into two groups: one receiving plain ropivacaine (Group 1) and other receiving ropivacaine with dexmedetomidine (Group 2) during TAP block. The patients in the two groups were compared for age, sex, body mass index, incidence of postoperative nausea, and vomiting and pain as measured on visual analog scale (VAS).
RESULTS
There was significantly lower pain score on VAS at 1, 3, 6, 12, and 18 h in Group 2 than in Group 1.
CONCLUSION
The addition of dexmedetomidine to ropivacaine during TAP block improves analgesic effect of TAP block and prolongs the duration of analgesia as well.",2017,"There was significantly lower pain score on VAS at 1, 3, 6, 12, and 18 h in Group 2 than in Group 1.
","['forty patients undergoing lower abdominal surgeries under general anesthesia', 'patients undergoing lower abdominal surgeries']","['Ultrasound-guided transversus abdominis plane (TAP) block', 'plain ropivacaine', 'ropivacaine with dexmedetomidine', 'ropivacaine', 'Ultrasound-guided transversus abdominis plane block', 'TAP blocks', 'dexmedetomidine']","['postoperative nausea, and vomiting and pain as measured on visual analog scale (VAS', 'analgesic effect of TAP block and prolongs the duration of analgesia', 'pain score on VAS', 'TAP block']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}]","[{'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",40.0,0.105453,"There was significantly lower pain score on VAS at 1, 3, 6, 12, and 18 h in Group 2 than in Group 1.
","[{'ForeName': 'Manjaree', 'Initials': 'M', 'LastName': 'Mishra', 'Affiliation': 'Department of Anesthesia, U. P. Rural Institute of Medical Sciences and Research, Saifai, Etawah, Uttar Pradesh, India.'}, {'ForeName': 'Shashi Prakash', 'Initials': 'SP', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, U. P. Rural Institute of Medical Sciences and Research, Saifai, Etawah, Uttar Pradesh, India.'}, {'ForeName': 'Somendra Pal', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, U. P. Rural Institute of Medical Sciences and Research, Saifai, Etawah, Uttar Pradesh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197348']
1825,28217056,Preprocedural ultrasound examination versus manual palpation for thoracic epidural catheter insertion.,"BACKGROUND AND AIMS
Ultrasound imaging before neuraxial blocks was reported to improve the ease of insertion and minimize the traumatic trials. However, the data about the use of ultrasound in thoracic epidural block are scanty. In this study, pre-insertion ultrasound scanning was compared to traditional manual palpation technique for insertion of the thoracic epidural catheter in abdominal operations.
SUBJECTS AND METHODS
Forty-eight patients scheduled to midline laparotomy under combined general anesthesia with thoracic epidural analgesia were included in the study. Patients were divided into two groups with regard to technique of epidural catheter insertion; ultrasound group (done ultrasound screening to determine the needle insertion point, angle of insertion, and depth of epidural space) and manual palpation group (used the traditional manual palpation technique). Number of puncture attempts, number of puncture levels, and number of needle redirection attempts were reported. Time of catheter insertion and complications were also reported in both groups.
RESULTS
Ultrasound group showed lower number of puncture attempts (1 [1, 1.25] vs. 1.5 [1, 2.75], P = 0.008), puncture levels (1 (1, 1) vs. 1 [1, 2], P = 0.002), and needle redirection attempts (0 [0, 2.25] vs. 3.5 [2, 5], P = 0.00). Ultrasound-guided group showed shorter time for catheter insertion compared to manual palpation group (140 ± 24 s vs. 213 ± 71 s P = 0.00).
CONCLUSION
Preprocedural ultrasound imaging increased the incidence of first pass success in thoracic epidural catheter insertion and reduced the catheter insertion time compared to manual palpation method.",2017,"RESULTS
Ultrasound group showed lower number of puncture attempts (1 [1, 1.25] vs. 1.5 [1, 2.75], P = 0.008), puncture levels (1 (1, 1) vs. 1 [1, 2], P = 0.002), and needle redirection attempts (0 [0, 2.25] vs. 3.5 [2, 5], P = 0.00).",['Forty-eight patients scheduled to'],"['midline laparotomy under combined general anesthesia with thoracic epidural analgesia', 'epidural catheter insertion; ultrasound group (done ultrasound screening to determine the needle insertion point, angle of insertion, and depth of epidural space) and manual palpation group (used the traditional manual palpation technique', 'Preprocedural ultrasound examination versus manual palpation for thoracic epidural catheter insertion']","['number of puncture attempts', 'needle redirection attempts', 'Time of catheter insertion and complications', 'Number of puncture attempts, number of puncture levels, and number of needle redirection attempts', 'shorter time for catheter insertion', 'catheter insertion time', 'puncture levels']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter, device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1301791', 'cui_str': 'Depth of epidural space'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",48.0,0.0277818,"RESULTS
Ultrasound group showed lower number of puncture attempts (1 [1, 1.25] vs. 1.5 [1, 2.75], P = 0.008), puncture levels (1 (1, 1) vs. 1 [1, 2], P = 0.002), and needle redirection attempts (0 [0, 2.25] vs. 3.5 [2, 5], P = 0.00).","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Hasanin', 'Affiliation': 'Department of Anesthesia, Kasr Alainy Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Mokhtar', 'Affiliation': 'Department of Anesthesia, Kasr Alainy Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Shereen M', 'Initials': 'SM', 'LastName': 'Amin', 'Affiliation': 'Department of Anesthesia, Kasr Alainy Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Sayed', 'Affiliation': 'Department of Anesthesia, Nasser Institute, Ministry of Health, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.197345']
1826,28060463,Upregulating the positive affect system in anxiety and depression: Outcomes of a positive activity intervention.,"BACKGROUND
Research suggests that the positive affect system may be an important yet underexplored treatment target in anxiety and depression. Existing interventions primarily target the negative affect system, yielding modest effects on measures of positive emotions and associated outcomes (e.g., psychological well-being). The objective of the present pilot study was to evaluate the efficacy of a new transdiagnostic positive activity intervention (PAI) for anxiety and depression.
METHOD
Twenty-nine treatment-seeking individuals presenting with clinically impairing symptoms of anxiety and/or depression were randomly allocated to a 10-session protocol comprised of PAIs previously shown in nonclinical samples to improve positive thinking, emotions, and behaviors (e.g., gratitude, acts of kindness, optimism; n = 16) or a waitlist (WL) condition (n = 13). Participants were assessed at pre- and posttreatment, as well as 3- and 6-month follow-up, on measures of positive and negative affect, symptoms, and psychological well-being. ClinicalTrials.gov Identifier: NCT02330627 RESULTS: The PAI group displayed significantly larger improvements in positive affect and psychological well-being from pre- to posttreatment compared to WL. Posttreatment and follow-up scores in the PAI group were comparable to general population norms. The PAI regimen also resulted in significantly larger reductions in negative affect, as well as anxiety and depression symptoms, compared to WL. Improvements across all outcomes were large in magnitude and maintained over a 6-month follow-up period.
CONCLUSIONS
Targeting the positive affect system through a multicomponent PAI regimen may be beneficial for generating improvements in positive emotions and well-being, as well as reducing negative affect and symptoms, in individuals with clinically impairing anxiety or depression.",2017,The PAI group displayed significantly larger improvements in positive affect and psychological well-being from pre- to posttreatment compared to WL.,"['individuals with clinically impairing anxiety or depression', 'Twenty-nine treatment-seeking individuals presenting with clinically impairing symptoms of anxiety and/or depression']","['new transdiagnostic positive activity intervention (PAI', 'positive activity intervention', '10-session protocol comprised of PAIs previously shown in nonclinical samples to improve positive thinking, emotions, and behaviors (e.g., gratitude, acts of kindness, optimism; n = 16) or a waitlist (WL) condition']",['anxiety and depression symptoms'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4280069', 'cui_str': 'Positive Thinking'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0421385,The PAI group displayed significantly larger improvements in positive affect and psychological well-being from pre- to posttreatment compared to WL.,"[{'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry, University of California , San Diego, CA, USA.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Lyubomirsky', 'Affiliation': 'Department of Psychology, University of California, Riverside, CA, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry, University of California , San Diego, CA, USA.'}]",Depression and anxiety,['10.1002/da.22593']
1827,32492153,VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population.,"CONTEXT
It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting.
OBJECTIVE
To determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk.
DESIGN
VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT including 25,871 adults, randomized November 2011-March 2014 and treated for 5.3 years (median).
SETTING
Nationwide study.
PARTICIPANTS
Men ≥50 and women ≥55 years (mean age 67.1 years) without cancer or cardiovascular disease at baseline.
INTERVENTIONS
Vitamin D3 (cholecalciferol; 2,000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2X2 factorial design.
MAIN OUTCOME MEASURES
Two or more falls, falls resulting in a doctor or hospital visit.
RESULTS
Baseline serum total 25-hydroxyvitamin D [25(OH)D] level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with ≥2 falls were similar between active and placebo groups (9.8% vs. 9.4%). Over 5 years, there were no differences in the proportion having ≥2 falls (OR=0.97; 95% CI, 0.90-1.05, p=0.50), falls resulting in a doctor visit (OR=1.03; 95% CI, 0.94-1.13, p=0.46) or resulting in a hospital visit (OR=1.04; 95% CI, 0.90-1.19, p=0.61) between groups. Results did not differ between those with baseline 25(OH)D <50 vs. >50 nmol/L or other cutpoints.
CONCLUSION
Daily supplemental vitamin D3 vs. placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the U.S. population.",2020,Results did not differ between those with baseline 25(OH)D,"['Men ≥50 and women ≥55 years (mean age 67.1 years) without cancer or cardiovascular disease at baseline', 'Nationwide study', '25,871 adults, randomized November 2011-March 2014 and treated for 5.3 years (median', 'generally healthy adults']","['vitamin D3 vs. placebo', 'supplemental vitamin D3', 'VITamin D and OmegA-3 TriaL (VITAL', 'placebo-controlled RCT', 'VITamin D and OmegA-3 TriaL', 'Vitamin D3 (cholecalciferol; 2,000 IU/day', 'Vitamin D Supplements', 'and/or omega-3 fatty acids (1 g/day) or respective placebos', 'vitamin D supplementation', 'placebo']","['proportion having ≥2 falls', 'falls resulting in a doctor visit', 'Risk of Falls', 'Baseline serum total 25-hydroxyvitamin D [25(OH)D] level', 'fall risk', 'falls, falls resulting in a doctor or hospital visit']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",25871.0,0.702356,Results did not differ between those with baseline 25(OH)D,"[{'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, MA, United States.""}, {'ForeName': 'Elle M', 'Initials': 'EM', 'LastName': 'Murata', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, MA, United States.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Cawthon', 'Affiliation': 'California Pacific Medical Center, Research Institute, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, MA, United States.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa311']
1828,30692889,Comparative study of mid-thoracic spinal versus epidural anesthesia for open nephrectomy in patients with obstructive/restrictive lung disease: A randomized controlled study.,"Background
The aim of this randomized controlled study is to compare the safety and efficacy of thoracic spinal versus thoracic epidural anesthesia for open nephrectomy in patients with obstructive/restrictive lung disease.
Methods
Sixty patients with mild to moderate chronic obstructive/restrictive lung disease undergoing open nephrectomy were randomized into two groups, 30 patients each. The thoracic spinal group (TSA) group received ultrasound guided mid-thoracic spinal anesthesia, and the thoracic epidural group (TEA) group received thoracic epidural anesthesia. All blocks were performed at the T7-T8. Hemodynamics, visual analogue scale score, sensory and motor block profile as well as any adverse events, and patient satisfaction were all reported.
Results
Both blocks were successfully performed and were effective for surgery in all patients, with the exception of only one patient in TSA group who needed to receive general anesthesia even after IV midazolam because of extreme anxiety and was excluded from the study analysis. The sensory block ranges were quiet close, with T2-T5 for the TSA group and T3-T6 for the TEA group as the upper level and L3-L5 as the same lower level. The values for the onset time and the duration of sensory and motor blocks were lower in TSA group. There were no statistically significant differences existed in intraoperative VAS, and hemodynamics between the two groups. Postoperative adverse effects were negligible and insignificant, with no case reporting any neurological sequel.
Conclusion
Ultrasound guided thoracic spinal anesthesia can be performed safely and effectively for open nephrectomy in patients with obstructive/restrictive lung disease with the potential for an early ambulation and great patient satisfaction.",2019,"There were no statistically significant differences existed in intraoperative VAS, and hemodynamics between the two groups.","['Sixty patients with mild to moderate chronic obstructive/restrictive lung disease undergoing open nephrectomy', 'patients with obstructive/restrictive lung disease']","['midazolam', 'TEA', 'mid-thoracic spinal versus epidural anesthesia', 'thoracic spinal versus thoracic epidural anesthesia', 'Ultrasound guided thoracic spinal anesthesia', 'ultrasound guided mid-thoracic spinal anesthesia, and the thoracic epidural group (TEA) group received thoracic epidural anesthesia', 'TSA', 'thoracic spinal group (TSA']","['safety and efficacy', 'Postoperative adverse effects', 'onset time and the duration of sensory and motor blocks', 'intraoperative VAS, and hemodynamics', 'Hemodynamics, visual analogue scale score, sensory and motor block profile as well as any adverse events, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0085581', 'cui_str': 'Restrictive lung disease (disorder)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1872220', 'cui_str': '(125I)-TSA'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",60.0,0.0292349,"There were no statistically significant differences existed in intraoperative VAS, and hemodynamics between the two groups.","[{'ForeName': 'Nazmy Edward', 'Initials': 'NE', 'LastName': 'Seif', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'ELbadawy', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_415_18']
1829,32079876,A Randomized Trial of Static and Articulating Spacers for the Treatment of Infection Following Total Knee Arthroplasty.,"BACKGROUND
There is no consensus whether the interim antibiotic spacer utilized in the 2-stage exchange arthroplasty should immobilize the joint or allow for motion. The purpose of this multicenter, randomized clinical trial was to compare static and articulating spacers as part of the 2-stage exchange arthroplasty for the treatment of chronic periprosthetic joint infection complicating total knee arthroplasty as defined with use of Musculoskeletal Infection Society criteria.
METHODS
Sixty-eight patients undergoing 2-stage exchange arthroplasty were randomized to either a static (32 patients) or an articulating (36 patients) spacer. An a priori power analysis determined that 28 patients per group would be necessary to detect a 13° difference in range of motion between groups. Six patients were excluded after randomization, 6 died, and 7 were lost to follow-up before 2 years.
RESULTS
Patients in the static group had a hospital length of stay that was 1 day greater than the articulating group after stage 1 (6.1 compared with 5.1 days; 95% confidence interval [CI], 5.3 to 6.9 days and 4.6 to 5.6 days, respectively; p = 0.032); no other differences were noted perioperatively. At a mean of 3.5 years (range, 2.0 to 6.4 years), 49 patients were available for evaluation. The mean motion arc was 113.0° (95% CI, 108.4° to 117.6°) in the articulating spacer group, compared with 100.2° (95% CI, 94.2° to 106.1°) in the static spacer group (p = 0.001). The mean Knee Society Score was higher in the articulating spacer cohort (79.4 compared with 69.8 points; 95% CI, 72.4 to 86.3 and 63.6 to 76.1, respectively; p = 0.043). Although not significantly different with the sample size studied, static spacers were associated with a greater need for an extensile exposure at the time of reimplantation (16.7% compared with 4.0%; 95% CI, 0.6% to 38.9% and 0.5% to 26.3%, respectively; p = 0.189) and a higher rate of reoperation (25.0% compared with 8.0%; 95% CI, 9.8% to 46.7% and 1.0% to 26.0%, respectively; p = 0.138).
CONCLUSIONS
Articulating spacers provided significantly greater range of motion and higher Knee Society scores at a mean of 3.5 years. Static spacers were associated with a longer hospital stay following removal of the infected implant. When the soft-tissue envelope allows and if there is adequate osseous support, an articulating spacer is associated with improved outcomes.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"RESULTS
Patients in the static group had a hospital length of stay that was 1 day greater than the articulating group after stage 1 (6.1 compared with 5.1 days; 95% confidence interval [CI], 5.3 to 6.9 days and 4.6 to 5.6 days, respectively; p = 0.032); no other differences were noted perioperatively.","['Total Knee Arthroplasty', 'chronic periprosthetic joint infection complicating total knee arthroplasty', 'Sixty-eight patients undergoing 2-stage exchange arthroplasty']","['Static and Articulating Spacers', '2-stage exchange arthroplasty']","['hospital length of stay', 'mean motion arc', 'rate of reoperation', 'hospital stay', 'mean Knee Society Score', 'range of motion and higher Knee Society scores']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0221874', 'cui_str': 'Spacer (physical object)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",68.0,0.234311,"RESULTS
Patients in the static group had a hospital length of stay that was 1 day greater than the articulating group after stage 1 (6.1 compared with 5.1 days; 95% confidence interval [CI], 5.3 to 6.9 days and 4.6 to 5.6 days, respectively; p = 0.032); no other differences were noted perioperatively.","[{'ForeName': 'Cindy R', 'Initials': 'CR', 'LastName': 'Nahhas', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Chalmers', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Parvizi', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Sporer', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Berend', 'Affiliation': 'Joint Implant Surgeons, Inc., New Albany, Ohio.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Moric', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Antonia F', 'Initials': 'AF', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Austin', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Deirmengian', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Joint Implant Surgeons, Inc., New Albany, Ohio.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00915']
1830,31519705,Enfortumab Vedotin Checks Urothelial Cancer.,"Treatment with enfortumab vedotin generated robust responses in patients with locally advanced or metastatic urothelial carcinoma. In a phase II trial of 125 patients who had previously received platinum-based chemotherapy and a PD-1 or PD-L1 checkpoint inhibitor, the overall response rate was 44%. Although nearly all patients experienced a treatment-related adverse event, most side effects were mild to moderate.",2019,"Although nearly all patients experienced a treatment-related adverse event, most side effects were mild to moderate.","['125 patients who had previously received', 'patients with locally advanced or metastatic urothelial carcinoma', 'Enfortumab Vedotin Checks Urothelial Cancer']","['platinum-based chemotherapy and a PD-1 or PD-L1 checkpoint inhibitor', 'enfortumab vedotin']",['overall response rate'],"[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",125.0,0.0248384,"Although nearly all patients experienced a treatment-related adverse event, most side effects were mild to moderate.",[],Cancer discovery,['10.1158/2159-8290.CD-NB2019-104']
1831,27833480,A comparison of oral midazolam and oral dexmedetomidine as premedication in pediatric anesthesia.,"CONTEXT
Oral premedication is widely used in pediatric anesthesia to provide preoperative anxiolysis and ensure smooth induction. Midazolam is currently the most commonly used premedicant, but newer drugs such as the α2-agonists have emerged as alternatives for premedication in children.
AIMS
The aim of this study was to compare clinical effects of oral midazolam and oral dexmedetomidine on preanesthetic sedation and postoperative recovery profile in children.
SETTINGS AND DESIGN
Randomized controlled trial.
MATERIALS AND METHODS
We performed a prospective, randomized, controlled study in 60 children, aged 1-7 years undergoing elective, minor, lower abdominal surgeries under general anesthesia. Patients were randomly assigned to receive either oral midazolam 0.75 mg/kg (Group M, n = 30) or oral dexmedetomidine 4 μg/kg (Group D, n = 30) 40 min prior to mask induction. Preoperative sedation and anxiolysis, the response at parental separation, quality of mask acceptance and recovery profile were compared for the two groups.
STATISTICAL ANALYSIS USED
Results were analyzed using unpaired Student's t -test and Chi-squared test. P < 0.05 was considered statistically significant.
RESULTS
There was no significant difference in the levels of preoperative sedation and anxiolysis between the two groups, but the onset of sedation was significantly faster with midazolam (18.90 ± 3.68 min) than with dexmedetomidine (30.50 ± 4.44 min). Response to parental separation and quality of mask acceptance was comparable between two groups ( P > 0.05). The incidence of postoperative agitation was significantly less in the dexmedetomidine group ( P < 0.05).
CONCLUSIONS
In this study, premedication with oral dexmedetomidine produced equally effective preoperative sedation and a better recovery from anesthesia in children in comparison to oral midazolam.",2016,"The incidence of postoperative agitation was significantly less in the dexmedetomidine group ( P < 0.05).
","['children', 'pediatric anesthesia', '60 children, aged 1-7 years undergoing elective, minor, lower abdominal surgeries under general anesthesia']","['midazolam', 'oral midazolam and oral dexmedetomidine', 'oral midazolam 0.75 mg/kg (Group M, n = 30) or oral dexmedetomidine', 'dexmedetomidine', 'Midazolam']","['Response to parental separation and quality of mask acceptance', 'incidence of postoperative agitation', 'levels of preoperative sedation and anxiolysis', 'effective preoperative sedation', 'onset of sedation', 'Preoperative sedation and anxiolysis, the response at parental separation, quality of mask acceptance and recovery profile']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}]","[{'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1961138', 'cui_str': 'Anxiolysis'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}]",60.0,0.0902134,"The incidence of postoperative agitation was significantly less in the dexmedetomidine group ( P < 0.05).
","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Jannu', 'Affiliation': 'Department of Anesthesiology, J. N. Medical College, Belagavi, Karnataka, India.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Mane', 'Affiliation': 'Department of Anesthesiology, J. N. Medical College, Belagavi, Karnataka, India.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Dhorigol', 'Affiliation': 'Department of Anesthesiology, J. N. Medical College, Belagavi, Karnataka, India.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Sanikop', 'Affiliation': 'Department of Anesthesiology, J. N. Medical College, Belagavi, Karnataka, India.'}]",Saudi journal of anaesthesia,[]
1832,32412960,Omega-3 fatty acid therapy for cardiovascular disease: justified or not?,"PURPOSE OF REVIEW
To discuss the current evidence regarding the relationship between omega-3 fatty acid intake and atherosclerotic cardiovascular disease (ASCVD) risk.
RECENT FINDINGS
Combined results from randomized controlled trials using low-dosage (≤1.8 g/day of ethyl esters) eicosapentaenoic acid (EPA) or EPA + docosahexaenoic acid (DHA) suggest a small benefit for reducing coronary heart disease risk. The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality. Several national organizations have recommended IPE for ASCVD risk reduction in populations aligning with REDUCE-IT; the Food and Drug Administration has approved IPE for ASCVD risk reduction. However, the Outcomes Study to Assess Statin Residual Risk Reduction with Epanova (EPA + DHA carboxylic acids) in High Cardiovascular Risk Patients with Hypertriglyceridemia was recently stopped for futility.
SUMMARY
At present, the best available evidence for a role of omega-3 fatty acids in ASCVD risk reduction is for 4 g/day of IPE, as an adjunct to statin therapy, for patients with ASCVD or diabetes mellitus and elevated triglycerides.",2020,"The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality.","['High Cardiovascular Risk Patients with Hypertriglyceridemia', 'patients with ASCVD or diabetes mellitus and elevated triglycerides']","['ethyl esters) eicosapentaenoic acid (EPA) or EPA + docosahexaenoic acid (DHA', 'Epanova (EPA + DHA carboxylic acids', 'omega-3 fatty acids', 'Omega-3 fatty acid therapy']","['Reduction of Cardiovascular Events', 'cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4026303', 'cui_str': 'Epanova'}, {'cui': 'C0007066', 'cui_str': 'Carboxylic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}]",,0.0504947,"The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, Boca Raton, Florida.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, Boca Raton, Florida.'}]",Current opinion in cardiology,['10.1097/HCO.0000000000000741']
1833,27833478,Comparison of rocuronium at two different doses and succinylcholine for endotracheal intubation in adult patients for elective surgeries.,"BACKGROUND
The effects of rocuronium at two different doses, that is, 0.6 mg/kg (2 × ED95) and 0.9 mg/kg (3 × ED95), were compared with succinylcholine (2 mg/kg) when used for endotracheal intubation in adult patients for elective surgeries under general anesthesia.
MATERIALS AND METHODS
Ninety patients were divided into three groups of 30 each. Groups A, B received injection rocuronium at 0.6 mg/kg, 0.9 mg/kg respectively and Group C received succinylcholine at 2 mg/kg. Onset of action of relaxant, intubation conditions, time taken to intubate and duration of action were compared.
STATISTICAL ANALYSIS USED
To compare the statistical difference in the age, weight, height of the study subjects, onset of action of relaxant, intubation conditions, time taken to intubate, and duration of action analysis of variance and unpaired t -test were used.
RESULTS
The onset time was considerably shorter with rocuronium 0.9 mg/kg than 0.6 mg/kg. The onset time of rocuronium 0.9 mg/kg was found to be significantly longer than succinylcholine 2 mg/kg. Time taken to intubate was shortest with succinylcholine 2 mg/kg. The time taken to intubate with the rocuronium 0.9 mg/kg was found to be comparable to that of rocuronium 0.6 mg/kg. Intubation score of rocuronium 0.9 mg/kg was the best (17.75), which was comparable with succinylcholine. However, the intubation score obtained with rocuronium 0.6 mg/kg was inferior. Duration of action was shortest with succinylcholine. The duration of action is prolonged when the dose of rocuronium is increased from 0.6 to 0.9 mg/kg.
CONCLUSION
Rapid sequence induction of anesthesia with propofol and fentanyl, succinylcholine allowed a more rapid endotracheal intubation sequence and created superior intubation conditions than rocuronium. However, the technique of using a large dose of rocuronium to achieve perfect conditions for tracheal intubation may have application whenever succinylcholine is relatively contraindicated.",2016,The onset time of rocuronium 0.9 mg/kg was found to be significantly longer than succinylcholine 2 mg/kg.,"['Ninety patients', 'adult patients for elective surgeries', 'adult patients for elective surgeries under general anesthesia']","['endotracheal intubation', 'injection rocuronium', 'succinylcholine', 'propofol and fentanyl, succinylcholine', 'rocuronium']","['Onset of action of relaxant, intubation conditions, time taken to intubate and duration of action', 'time taken to intubate', 'duration of action', 'Intubation score', 'rapid endotracheal intubation sequence and created superior intubation conditions', 'Duration of action', 'onset time']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",90.0,0.291471,The onset time of rocuronium 0.9 mg/kg was found to be significantly longer than succinylcholine 2 mg/kg.,"[{'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Chavan', 'Affiliation': 'Department of Anesthesiology, ESIC Medical College and Hospital, Parippally, Kollam, Kerala, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gangadharan', 'Affiliation': 'Department of Anesthesiology, ESIC Medical College and Hospital, Parippally, Kollam, Kerala, India.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Gopakumar', 'Affiliation': 'Department of Anesthesiology, ESIC Medical College and Hospital, Parippally, Kollam, Kerala, India.'}]",Saudi journal of anaesthesia,[]
1834,27833479,Efficacy of dexmedetomidine as an adjuvant to ropivacaine in pediatric caudal epidural block.,"CONTEXT
Caudal analgesia is a reliable and an easy method to provide intraoperative and postoperative analgesia for infraumbilical surgeries in pediatric population but with the disadvantage of short duration of action after single injection. Many additives were used in combination with local anesthetics in the caudal block to prolong the postoperative analgesia.
AIM
We compared the analgesic effects and side effects of dexmedetomidine added to ropivacaine in pediatric patients undergoing lower abdominal surgeries.
SETTINGS AND DESIGN
Double-blinded randomized controlled trial.
MATERIALS AND METHODS
Sixty patients (2-10 years) were evenly and randomly assigned into two groups in a double-blinded manner. After sevoflurane in oxygen anesthesia, each patient received a single caudal dose of ropivacaine 0.25% (1 ml/kg) combined with either dexmedetomidine 2 μg/kg in normal saline 0.5 ml, or corresponding volume of normal saline according to group assignment. Hemodynamic variables, end-tidal sevoflurane, and emergence time were monitored. Postoperative analgesia, requirement of additional analgesic, sedation, and side effects were assessed during the first 24 h.
RESULTS
The duration of postoperative analgesia was significantly longer ( P = 0.001) and total consumption of rescue analgesic was significantly lower in Group RD compared with Group R ( P < 0.05). Group RD have better quality of sleep and prolonged duration of sedation ( P = 0.001). No significant difference was observed in the incidence of hemodynamic changes or side effects.
CONCLUSION
Addition of dexmedetomidine to caudal ropivacaine significantly prolongs analgesia in children undergoing lower abdominal surgeries without an increase in the incidence of side effects.",2016,The duration of postoperative analgesia was significantly longer ( P = 0.001) and total consumption of rescue analgesic was significantly lower in Group RD compared with Group R ( P < 0.05).,"['pediatric patients undergoing lower abdominal surgeries', 'pediatric caudal epidural block', 'Sixty patients (2-10 years', 'children undergoing lower abdominal surgeries']","['dexmedetomidine', 'dexmedetomidine 2 μg/kg in normal saline 0.5 ml, or corresponding volume of normal saline', 'ropivacaine', 'sevoflurane']","['Hemodynamic variables, end-tidal sevoflurane, and emergence time', 'hemodynamic changes or side effects', 'total consumption of rescue analgesic', 'duration of postoperative analgesia', 'incidence of side effects', 'analgesia', 'quality of sleep and prolonged duration of sedation', 'Postoperative analgesia, requirement of additional analgesic, sedation, and side effects']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block (procedure)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",60.0,0.660205,The duration of postoperative analgesia was significantly longer ( P = 0.001) and total consumption of rescue analgesic was significantly lower in Group RD compared with Group R ( P < 0.05).,"[{'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Anesthesiology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Sadik', 'Initials': 'S', 'LastName': 'Mohammed', 'Affiliation': 'Department of Anesthesiology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Meena', 'Affiliation': 'Department of Anesthesiology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Singariya', 'Affiliation': 'Department of Anesthesiology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesiology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Dilip Singh', 'Initials': 'DS', 'LastName': 'Chauhan', 'Affiliation': 'Department of Anesthesiology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.'}]",Saudi journal of anaesthesia,[]
1835,28105733,Vitamin D supplementation for sickle cell disease.,"BACKGROUND
Sickle cell disease is a genetic chronic haemolytic and pro-inflammatory disorder. The clinical manifestations of sickle cell disease result from the presence of mutations on the beta globin genes that generate an abnormal haemoglobin product (called haemoglobin S) within the red blood cell. Sickle cell disease can lead to many complications such as acute chest syndrome, stroke, acute and chronic bone complications (including painful vaso-occlusive crisis, osteomyelitis, osteonecrosis and osteoporosis). With increased catabolism and deficits in energy and nutrient intake, individuals with sickle cell disease suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency. Since vitamin D maintains calcium homeostasis and is essential for bone mineralisation, its deficiency may worsen musculoskeletal health problems encountered in sickle cell disease. Therefore, there is a need to review the effects and the safety of vitamin D supplementation in sickle cell disease.
OBJECTIVES
To investigate the hypothesis that vitamin D supplementation increases serum 25-hydroxyvitamin D level in children and adults with sickle cell disease.To determine the effects of vitamin D supplementation on general health such as growth status and health-related quality of life; on musculoskeletal health including bone mineral density, pain crises, bone fracture and muscle health; on respiratory health which includes lung function tests, acute chest syndrome, acute exacerbation of asthma and respiratory infections; and the safety of vitamin D supplementation in children and adults with sickle cell disease.
SEARCH METHODS
We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched database such as PubMed, clinical trial registries and the reference lists of relevant articles and reviews.Date of last search: 15 December 2016.
SELECTION CRITERIA
Randomised controlled studies and quasi-randomised controlled studies (controlled clinical studies) comparing oral administration of any form of vitamin D supplementation to another type of vitamin D or placebo or no supplementation at any dose and for any duration, in people with sickle cell disease, of all ages, gender, and phenotypes including sickle cell anaemia, haemoglobin sickle cell disease and sickle beta-thalassaemia diseases.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted the data and assessed the risk of bias of the included study. They used the GRADE guidelines to assess the quality of the evidence.
MAIN RESULTS
One double-blind randomised controlled study including 46 people with sickle cell disease (HbSS, HbSC, HbSβ+thal and HbSβ0thal) was eligible for inclusion in this review. Of the 46 enrolled participants, seven withdrew before randomisation leaving 39 participants who were randomised. Only 25 participants completed the full six months of follow up. Participants were randomised to receive oral vitamin D3 (cholecalciferol) (n = 20) or placebo (n = 19) for six weeks and were followed up to six months. Two participants from the treatment group have missing values of baseline serum 25-hydroxyvitamin D, therefore the number of samples analysed was 37 (vitamin D n = 18, placebo n = 19).The included study had a high risk of bias with regards to incomplete outcome data (high dropout rate in the placebo group), but a low risk of bias for other domains such as random sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, selective outcome reporting; and an unclear risk of other biases.Compared to the placebo group, the vitamin D group had significantly higher serum 25-hydroxyvitamin D (25(OH)D) levels at eight weeks, mean difference 29.79 (95% confidence interval 26.63 to 32.95); at 16 weeks, mean difference 12.67 (95% confidence interval 10.43 to 14.90); and at 24 weeks, mean difference 15.52 (95% confidence interval 13.50 to 17.54). We determined the quality of the evidence for this outcome to be moderate. There was no significant difference of adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% confidence interval 0.14 to 72.84), but the quality of the evidence was low. Regarding the frequency of pain, the vitamin D group had significantly fewer pain days compared to the placebo group, mean difference -10.00 (95% confidence interval -16.47 to -3.53), but again the quality of the evidence was low. Furthermore, the review included physical functioning PedsQL scores which was reported as absolute change from baseline. The vitamin D group had a lower (worse) health-related quality of life score than the placebo group but this was not significant at eight weeks, mean difference -2.02 (95% confidence interval -6.34 to 2.30). However, the difference was significant at both 16 weeks, mean difference -12.56 (95% confidence interval -16.44 to -8.69) and 24 weeks, mean difference -12.59 (95% confidence interval -17.43 to -7.76). We determined the quality of evidence for this outcome to be low.
AUTHORS' CONCLUSIONS
We included only one low-quality clinical study which had a high risk of bias with regards to incomplete outcome data. Therefore, we consider that the evidence is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation (e.g. the Endocrine Society Clinical Practice Guidelines) and dietary reference intakes for calcium and vitamin D (e.g. from the USA Institute of Medicine). Evidence of vitamin D supplementation in sickle cell disease from high quality studies is needed. Well-designed, randomised, placebo-controlled studies of parallel design, are required to determine the effects and the safety of vitamin D supplementation in children and adults with sickle cell disease.",2017,"There was no significant difference of adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% confidence interval 0.14 to 72.84), but the quality of the evidence was low.","['people with sickle cell disease, of all ages, gender, and phenotypes including sickle cell anaemia, haemoglobin sickle cell disease and sickle beta-thalassaemia diseases', 'individuals with sickle cell disease suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency', 'sickle cell disease', '46 people with sickle cell disease (HbSS, HbSC, HbSβ+thal and HbSβ0thal', 'children and adults with sickle cell disease', '46 enrolled participants, seven withdrew before randomisation leaving 39 participants who were randomised']","['vitamin D', 'vitamin D supplementation', 'placebo', 'Vitamin D supplementation', 'vitamin D or placebo or no supplementation', 'oral vitamin D3 (cholecalciferol']","['frequency of pain', 'general health such as growth status and health-related quality of life', 'serum 25-hydroxyvitamin D level', 'pain days', 'adverse events (tingling of lips or hands', 'serum 25-hydroxyvitamin D (25(OH)D) levels', 'lower (worse) health-related quality of life score', 'missing values of baseline serum 25-hydroxyvitamin D']","[{'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte (cell)'}, {'cui': 'C0005283', 'cui_str': 'Microcytemia, beta Type'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2242996', 'cui_str': 'Tingling'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",46.0,0.749159,"There was no significant difference of adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% confidence interval 0.14 to 72.84), but the quality of the evidence was low.","[{'ForeName': 'Htoo Htoo Kyaw', 'Initials': 'HH', 'LastName': 'Soe', 'Affiliation': 'Department of Community Medicine, Melaka-Manipal Medical College, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Adinegara Bl', 'Initials': 'AB', 'LastName': 'Abas', 'Affiliation': 'Department of Community Medicine, Melaka-Manipal Medical College, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Nan Nitra', 'Initials': 'NN', 'LastName': 'Than', 'Affiliation': 'Department of Community Medicine, Melaka-Manipal Medical College, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Internal Medicine, Faculty of Medicine, SEGi University, Hospital Sibu, Jalan Ulu Oya, Sibu, Sarawak, Malaysia, 96000.'}, {'ForeName': 'Jaspal', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Faculty of Medicine, Melaka-Manipal Medical College, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Abdul Razzak Bin Mohd', 'Initials': 'AR', 'LastName': 'Said', 'Affiliation': 'Melaka-Manipal Medical College, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Ifeyinwa', 'Initials': 'I', 'LastName': 'Osunkwo', 'Affiliation': 'Comprehensive Sickle Cell Program, Aflac Cancer and Blood Disorders Service, Emory University School of Medicine, 1405 Clifton Road, NE, Atlanta, Georgia, USA, GA 30322.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010858.pub2']
1836,32413002,Baseline and Clinical Factors Associated with Response to Amblyopia Treatment in a Randomized Clinical Trial.,"SIGNIFICANCE
We sought to identify baseline and clinical factors that were predictive of the response to amblyopia treatment. We report that binocular amblyopia treatment may be especially effective for moderate amblyopia in orthotropic children.
PURPOSE
We previously reported results from the primary cohort (n = 28) enrolled in a randomized clinical trial (NCT02365090), which found that binocular amblyopia treatment was more effective than patching. Enrollment of an additional 20 children was pre-planned to provide the opportunity to examine factors that may be predictive of response to amblyopia treatment.
METHODS
Forty-eight children (4 to 10 years old) were enrolled, with 24 randomized to contrast-rebalanced binocular game treatment (1 hour a day, 5 days a week) and 24 to patching treatment (2 hours a day, 7 days a week). The primary outcome was change in amblyopic eye best-corrected visual acuity at the 2-week visit. Baseline factors examined were age at enrollment, visual acuity, stereoacuity, and suppression. Clinical factors were etiology, age at diagnosis, prior treatment, and ocular alignment.
RESULTS
At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching. Children with moderate amblyopia and orthotropia had more visual acuity improvement with binocular game play than did those with severe amblyopia. In addition, children who spent more time playing the binocular game had more improvement. We were not able to confidently identify any baseline or clinical factors that were associated with response to patching treatment.
CONCLUSIONS
Binocular amblyopia treatment was more effective among orthotropic children with moderate amblyopia than among children with microtropia or severe amblyopia.",2020,"At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching.","['orthotropic children with moderate amblyopia than among children with microtropia or severe amblyopia', 'Children with moderate amblyopia and orthotropia', 'Forty-eight children (4 to 10 years old']","['binocular amblyopia treatment', 'Binocular amblyopia treatment', 'contrast-rebalanced binocular game treatment']","['change in amblyopic eye best-corrected visual acuity', 'visual acuity, stereoacuity, and suppression', 'visual acuity improvement', 'time playing the binocular game']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0271356', 'cui_str': 'Microstrabismus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}]",48.0,0.177459,"At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching.","[{'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Kelly', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Leffler', 'Affiliation': ""Children's Eye Care of North Texas, PA, Plano, Texas.""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Dao', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, PA, Dallas, Texas.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Beauchamp', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, PA, Dallas, Texas.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001514']
1837,32413383,Cost-effectiveness of adding fluoride varnish to a preventive protocol for early childhood caries in rural children with no access to fluoridated drinking water.,"OBJECTIVES
Evidence of the cost-effectiveness of fluoride varnish in the prevention of caries is not yet fully conclusive. The aim of this study was to assess the incremental cost-effectiveness ratio (ICER) of the community-wide application of fluoride varnish in the prevention of early childhood caries (ECC) in non-fluoridated areas.
MATERIALS AND METHODS
A cost-effectiveness analysis was carried out based on a clinical decision tree from the payer's perspective. The effectiveness and cost of the varnish were determined from a two-year follow-up triple-blind randomized control trial in 275 two- to three-year-old children. Costs and benefits were discounted at 3% per year. Only direct costs were evaluated, expressed in Chilean pesos (CLP) valued in July, 2019 (exchange rate USD = CLP686.06). A univariate deterministic sensitivity analysis was carried out.
RESULTS
Incidence of ECC was 45 % for the varnish group and 55.6 % for the placebo group with a two-year follow-up. The weighted cost to intervene and treat the consequences of ECC was CLP 67,757 (USD98.76) for the fluoride varnish and CLP 67,739 (USD98.74) for the control group. The ICER was CLP 173 (USD0.25) for each extra healthy child in favor of fluoride varnish. The sensitivity analysis showed that the increase in caries was the variable which most influenced the ICER.
CONCLUSIONS
The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo.
CLINICAL SIGNIFICANCE
Findings support the application of fluoride varnish as a cost-effective community strategy to prevent ECC in non-fluoridated areas.",2020,"The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo.
","['rural children with no access to fluoridated drinking water', '275 two- to three-year-old children', 'early childhood caries (ECC) in non-fluoridated areas']","['fluoride varnish', 'placebo']","['Cost-effectiveness', 'Costs and benefits', 'caries', 'incremental cost-effectiveness ratio (ICER', 'Incidence of ECC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]",,0.119731,"The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo.
","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zaror', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile. Electronic address: carlos.zaror@ufrontera.cl.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Muñoz-Millán', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: patricia.munoz@ufrontera.cl.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Espinoza-Espinoza', 'Affiliation': 'Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Department of Public Health, Faculty of Medicine, Universidad de La Frontera, Temuco, Chile. Electronic address: gerardo.espinoza@ufrontera.cl.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Vergara-González', 'Affiliation': 'Aysén Health Service, Coyhaique, Chile. Electronic address: carovergarag@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Martínez-Zapata', 'Affiliation': 'Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: MMartinezz@santpau.cat.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103374']
1838,32413581,Trauma-related cognitions predict treatment response in smokers with PTSD: Evidence from cross-lagged panel analyses.,"OBJECTIVE
Compared to smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke more heavily and are less successful in quitting smoking. However, limited research has examined the cognitive pathways underlying this heightened comorbidity. The current study is the first to simultaneously model the cross-sectional and lagged relationships between trauma-related cognitions and cigarette smoking, as well as between trauma-related cognitions and PTSD severity, in smokers with comorbid PTSD receiving treatment.
METHOD
Participants (n = 142) were seeking treatment for smoking cessation and PTSD as part of a randomized controlled trial of varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline + PE vs. varenicline only) (Foa et al., 2017). Data were available for both baseline and end-of-treatment assessments of trauma cognitions severity of cigarette smoking and PTSD symptoms. We conducted both cross-sectional and lagged analysis to simultaneously examine the bidirectional relationship from trauma cognitions and 1) cigarette smoking and 2) PTSD symptoms.
RESULTS
Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only. However, baseline trauma cognitions did not predict post-treatment cigarettes/day. Baseline trauma cognitions (specifically negative beliefs about the self and world) were associated with PTSD severity at both baseline and end of treatment; furthermore, these negative cognitions at baseline positively and prospectively predicted end-of-treatment PTSD severity, but not vice versa. Wald tests revealed that there were no treatment effects on these cross-lagged relationships. Conclusions These findings provide novel empirical support for the importance of addressing trauma-related cognitions in the smoking cessation treatment efforts for patients with comorbid PTSD and cigarette smoking.",2020,"RESULTS
Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","['smokers with PTSD', 'patients with comorbid PTSD and cigarette smoking', 'smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke', 'Participants (n\u202f=\u202f142) were', 'smokers with comorbid PTSD receiving treatment']","['varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline\u202f+\u202fPE vs. varenicline only', 'varenicline', 'seeking treatment for smoking cessation and PTSD']","['Baseline trauma cognitions', 'baseline trauma cognitions', 'PTSD severity', 'trauma cognitions severity of cigarette smoking and PTSD symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",142.0,0.00981447,"RESULTS
Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","[{'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Mu', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: wenting.mu@pennmedicine.upenn.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Narine', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology, Rutgers University, The State University of New Jersey, United States.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Lieblich', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Bredemeier', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106376']
1839,27883237,Iron concentration in breast milk normalised within one week of a single high-dose infusion of iron isomaltoside in randomised controlled trial.,"AIM
We compared the iron concentration in breast milk after a single high dose of intravenous iron isomaltoside or daily oral iron for postpartum haemorrhage.
METHODS
In this randomised controlled trial, the women were allocated a single dose of intravenous 1200 mg iron isomaltoside or oral iron at a mean daily dose of 70.5 mg. We included 65 women with sufficient breast milk three days after inclusion - 30 from the intravenous iron group and 35 from the oral iron group - and collected breast milk and maternal blood samples three days and one week after allocation.
RESULTS
The mean (±SD) iron concentration in breast milk in the intravenous and oral groups was 0.72 ± 0.27 and 0.40 ± 0.18 mg/L at three days (p < 0.001) and 0.47 ± 0.17 and 0.44 ± 0.25 mg/L after one week (p = 0.64). Baseline samples were not available that soon after birth.
CONCLUSION
A single high dose of intravenous iron isomaltoside for postpartum haemorrhage led to a transient increase in the iron concentration in breast milk three days after treatment compared with oral iron. The difference disappeared one week after treatment, and mean iron concentrations were within the normal range in all samples.",2017,A single high dose of intravenous iron isomaltoside for postpartum haemorrhage led to a transient increase in the iron concentration in breast milk three days after treatment compared with oral iron.,['65 women with sufficient breast milk three days after inclusion - 30 from the intravenous iron group and 35 from the oral iron group - and collected breast milk and maternal blood samples three days and one week after allocation'],"['intravenous iron isomaltoside', 'intravenous iron isomaltoside or daily oral iron', 'intravenous 1200 mg iron isomaltoside or oral iron']","['mean iron concentrations', 'mean (±SD) iron concentration in breast milk']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}]",65.0,0.671015,A single high dose of intravenous iron isomaltoside for postpartum haemorrhage led to a transient increase in the iron concentration in breast milk three days after treatment compared with oral iron.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Holm', 'Affiliation': 'Department of Obstetrics, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars Lykke', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Pharmacosmos A/S, Holbaek, Denmark.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Norgaard', 'Affiliation': 'Section for Transfusion Medicine 2034, Capital Region Blood Bank, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Markova', 'Affiliation': 'Department of Obstetrics, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Langhoff-Roos', 'Affiliation': 'Department of Obstetrics, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.13681']
1840,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE
Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial.
MATERIAL AND METHODS
A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed.
RESULTS
Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
CONCLUSION
Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006']
1841,32413595,Double trouble: Do symptom severity and duration interact to predicting treatment outcomes in adolescent depression?,"Studies suggest that depression severity and duration interact to predict outcomes in depression treatment. To our knowledge, no study has explored this question in a sample with a placebo control, two therapies, and their combination nor with adolescents. We used data from the Treatment of Adolescent Depression Study (N = 439), in which adolescent were randomized to placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB). We explore the interaction between depression severity, chronicity, and treatments (vs. placebo) in predicting outcomes. There was interaction between severity and chronicity when comparing COMB and CBT with PBO, but not MEDs. In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression. In chronic depression, the effects of CBT did not vary by severity, but the relative effects of COMB grew, being smallest in milder, more dysthymic-like depression, and largest in chronic-severe depression. These findings support calls to classify depression by severity and chronicity as well efforts to risk stratify patients to different intensity of care according to these variables.",2020,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.",['Adolescent Depression Study (N\xa0=\xa0439'],"['CBT', 'placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB', 'placebo']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],,0.0183832,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lorenzo-Luaces', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA. Electronic address: lolorenz@indiana.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rodriguez-Quintana', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Allen J', 'Initials': 'AJ', 'LastName': 'Bailey', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103637']
1842,27833481,Cardiac and renal protective effects of dexmedetomidine in cardiac surgeries: A randomized controlled trial.,"BACKGROUND
Cardiac and renal injuries are common insults after cardiac surgeries that contribute to perioperative morbidity and mortality. Dexmedetomidine has been shown to protect several organs against ischemia/reperfusion-(I/R) induced injury. We performed a randomized controlled trial to assess the effect of dexmedetomidine on cardiac and renal I/R injury in patients undergoing cardiac surgeries.
MATERIALS AND METHODS
Fifty patients scheduled for elective cardiac surgeries were randomized to dexmedetomidine group that received a continuous infusion of dexmedetomidine initiated 5 min before cardiopulmonary bypass (1 μg/kg over 15 min, followed by 0.5 μg/kg/h) until 6 h after surgery, whereas the control group received an equivalent volume of physiological saline. Primary outcome measures included myocardial-specific proteins (troponin-I, creatine kinase-MB), urinary-specific kidney proteins (N-acetyl-beta-D-glucosaminidase, alpha-1-microglobulin, glutathione transferase-pi, glutathione transferase alpha), serum proinflammatory cytokines (tumor necrosis factor alpha and interleukin-1 beta), norepinephrine, and cortisol levels. They were measured within 5 min of starting anesthesia (T 0 ), at the end of surgery (T 1 ), 12 h after surgery (T 2 ), 24 h after surgery (T 3 ), 36 h postoperatively (T 4 ), and 48 h postoperatively (T 5 ). Furthermore, creatinine clearance and serum cystatin C were measured before starting surgery as a baseline, and at days 1, 4, 7 after surgery.
RESULTS
Dexmedetomidine reduced cardiac and renal injury as evidenced by lower concentration of myocardial-specific proteins, kidney-specific urinary proteins, and pro-inflammatory cytokines. Moreover, it caused higher creatinine clearance and lower serum cystatin C.
CONCLUSION
Dexmedetomidine provided cardiac and renal protection during cardiac surgery.",2016,"RESULTS
Dexmedetomidine reduced cardiac and renal injury as evidenced by lower concentration of myocardial-specific proteins, kidney-specific urinary proteins, and pro-inflammatory cytokines.","['cardiac surgeries', 'patients undergoing cardiac surgeries', 'Fifty patients scheduled for elective cardiac surgeries']","['dexmedetomidine', 'Dexmedetomidine', 'dexmedetomidine initiated 5 min before cardiopulmonary bypass', 'control group received an equivalent volume of physiological saline']","['Cardiac and renal protective effects', 'alpha and interleukin-1 beta), norepinephrine, and cortisol levels', 'lower concentration of myocardial-specific proteins, kidney-specific urinary proteins, and pro-inflammatory cytokines', 'Furthermore, creatinine clearance and serum cystatin C', 'cardiac and renal injury', 'creatinine clearance', 'myocardial-specific proteins (troponin-I, creatine kinase-MB), urinary-specific kidney proteins (N-acetyl-beta-D-glucosaminidase, alpha-1-microglobulin, glutathione transferase-pi, glutathione transferase alpha), serum proinflammatory cytokines (tumor necrosis factor']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0021753', 'cui_str': 'Catabolin'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney (disorder)'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0001057', 'cui_str': 'N-Acetyl-beta-D-glucosaminidase'}, {'cui': 'C2939113', 'cui_str': 'Alpha 1 microglobulin'}, {'cui': 'C0017837', 'cui_str': 'Glutathione Organic Nitrate Ester Reductase'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",50.0,0.412079,"RESULTS
Dexmedetomidine reduced cardiac and renal injury as evidenced by lower concentration of myocardial-specific proteins, kidney-specific urinary proteins, and pro-inflammatory cytokines.","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Ammar', 'Affiliation': 'Asst. Professor in Anesthesiology Department, Minoufiya Faculty of Medicine, Minoufiya University, Minoufiya, Egypt.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Mahmoud', 'Affiliation': 'Asst. Professor in Anesthesiology Department, Minoufiya Faculty of Medicine, Minoufiya University, Minoufiya, Egypt.'}, {'ForeName': 'Z A', 'Initials': 'ZA', 'LastName': 'Kasemy', 'Affiliation': 'Lecturer in Public Health, Statistics and Community Medicine Department, Minoufiya Faculty of Medicine, Minoufiya University, Minoufiya, Egypt.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Helwa', 'Affiliation': 'Lecturer in Clinical Pathology Department, Minoufiya Faculty of Medicine, Minoufiya University, Minoufiya, Egypt.'}]",Saudi journal of anaesthesia,[]
1843,27833486,A comparative study of dexmedetomidine and fentanyl as adjuvants to levobupivacaine for caudal analgesia in children undergoing lower limb orthopedic surgery.,"BACKGROUND
Levobupivacaine is an effective local anesthetic agent with less systemic toxicity than racemic bupivacaine, but it has short postoperative analgesic duration. Dexmedetomidine and fentanyl are promising adjuncts to provide excellent and prolonged postoperative caudal analgesia. This study compared the effects of caudal levobupivacaine plus dexmedetomidine and levobupivacaine plus fentanyl for postoperative analgesia and sedation in children undergoing lower limb orthopedic surgery.
PATIENTS AND METHODS
Ninety children, whose age ranged from 1 to 7 years, American Society of Anesthesiologists I-II, undergoing orthopedic lower limb surgery under general anesthesia received caudal block for postoperative analgesia. The children were randomly allocated into three groups: Group L (control) received 0.75 ml/kg levobupivacaine 0.25% diluted in saline; Group LD received 0.75 ml/kg levobupivacaine 0.25% with dexmedetomidine 1 μg/kg; and Group LF received 0.75 ml/kg levobupivacaine 0.25% with fentanyl 1 μg/kg. Following the administration of the drugs; hemodynamic variables, the total anesthesia time, sedation score, Face, Legs, Activity, Cry, Consolability score, duration of analgesia, and side effects were recorded.
RESULTS
Demographically, all the groups were comparable, both the baseline and the intraoperative hemodynamic profile were similar in all groups. The mean duration of analgesia and the mean sedation score in the Group LD were significantly greater as compared to both the other groups.
CONCLUSION
Dexmedetomidine may be a better additive to levobupivacaine than fentanyl for caudal postoperative analgesia, arousable sedation with comparable hemodynamic and side effect profile in children.",2016,"The mean duration of analgesia and the mean sedation score in the Group LD were significantly greater as compared to both the other groups.
","['children', 'children undergoing lower limb orthopedic surgery', 'Ninety children, whose age ranged from 1 to 7 years, American Society of Anesthesiologists I-II, undergoing orthopedic lower limb surgery under general anesthesia received caudal block for postoperative analgesia']","['Levobupivacaine', 'Dexmedetomidine', 'levobupivacaine plus fentanyl', 'levobupivacaine', 'Dexmedetomidine and fentanyl', 'caudal levobupivacaine plus dexmedetomidine', 'dexmedetomidine and fentanyl', 'Group L (control) received 0.75 ml/kg levobupivacaine 0.25% diluted in saline; Group LD received 0.75 ml/kg levobupivacaine 0.25% with dexmedetomidine 1 μg/kg; and Group LF received 0.75 ml/kg levobupivacaine 0.25% with fentanyl', 'racemic bupivacaine']","['postoperative analgesia and sedation', 'mean duration of analgesia and the mean sedation score', 'total anesthesia time, sedation score, Face, Legs, Activity, Cry, Consolability score, duration of analgesia, and side effects', 'intraoperative hemodynamic profile']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0441846', 'cui_str': 'Group L (qualifier value)'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",90.0,0.153421,"The mean duration of analgesia and the mean sedation score in the Group LD were significantly greater as compared to both the other groups.
","[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Elfawal', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Abdelaal', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Hosny', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,[]
1844,31859575,Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial.,"The aim of this study was to compare inflammatory response and synovial metaplasia in implant-based immediate breast reconstruction with a biological mesh (Veritas ® ) with that of a synthetic mesh (TIGR ® Matrix Surgical Mesh). We hypothesize that the inflammatory response and formation of synovial metaplasia might be different and the rate of capsular contracture therefore different. The patients were recruited from the Gothenburg TIGR ® /Veritas ® Study (ClinicalTrials.Gov identifier NCT02985073). All referrals for bilateral immediate breast reconstruction were assessed for inclusions. During the operation, the patients were randomized to which sides the biological and the synthetic mesh were going to be applied. During the implant exchange biopsies were taken. Biopsies were taken from 30 breasts in 15 patients. There seem to be more myofibroblast and neovascularization in the biological meshes than in the synthetic and the collagen fibers seem to be aligned in an irregular pattern with both parallel and vertical fibers. In the synthetic meshes, there were more giant cells and foreign body reaction and the collagen fibers were loosely and well aligned, oriented parallel to the surface of the implant. Synovial metaplasia was seen in the majority of both the biological and the synthetic meshes. The histological patterns in early capsules from biological and synthetic meshes vary considerably. Nonetheless, it is unknown what role different cell types have in capsular formation in the long run and there was no difference in clinical capsular contracture at the clinical follow-up in this study.",2020,There seem to be more myofibroblast and neovascularization in the biological meshes than in the synthetic and the collagen fibers seem to be aligned in an irregular pattern with both parallel and vertical fibers.,['patients were recruited from the Gothenburg TIGR ® /Veritas ® Study (ClinicalTrials'],"['implant-based immediate breast reconstruction with a biological mesh (Veritas ® ', 'immediate breast reconstruction with a synthetic and a biological mesh', 'synthetic mesh (TIGR ® Matrix Surgical Mesh']","['inflammatory response and synovial metaplasia', 'Synovial metaplasia', 'giant cells and foreign body reaction and the collagen fibers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0038930', 'cui_str': 'Surgical Mesh'}]","[{'cui': 'C1302824', 'cui_str': 'Synovial metaplasia'}, {'cui': 'C0017526', 'cui_str': 'Syncytium'}, {'cui': 'C0016549', 'cui_str': 'Foreign-Body Reaction'}, {'cui': 'C0225325', 'cui_str': 'Collagen fiber (substance)'}]",,0.0318531,There seem to be more myofibroblast and neovascularization in the biological meshes than in the synthetic and the collagen fibers seem to be aligned in an irregular pattern with both parallel and vertical fibers.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hansson', 'Affiliation': 'The Sahlgrenska Academy, Department of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Burian', 'Affiliation': 'Department of Pathology, Unilabs, Skövde, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Hallberg', 'Affiliation': 'The Sahlgrenska Academy, Department of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}]",Journal of plastic surgery and hand surgery,['10.1080/2000656X.2019.1704766']
1845,26543448,"Dexmedetomidine as an adjunct in postoperative analgesia following cardiac surgery: A randomized, double-blind study.","OBJECTIVES
The purpose of this study was to determine analgesic efficacy of dexmedetomidine used as a continuous infusion without loading dose in postcardiac surgery patients.
SETTINGS AND DESIGN
A prospective, randomized, double-blind clinical study in a single tertiary care hospital on patients posted for elective cardiac surgery under cardiopulmonary bypass.
INTERVENTIONS
Sixty-four patients who underwent elective cardiac surgery under general anesthesia were shifted to intensive care unit (ICU) and randomly divided into two groups. Group A (n = 32) received a 12 h infusion of normal saline and group B (n = 32) received a 12 h infusion of dexmedetomidine 0.4 μg/kg/h. Postoperative pain was managed with bolus intravenous fentanyl. Total fentanyl consumption, hemodynamic monitoring, Visual Analogue Scale (VAS) pain ratings, Ramsay Sedation Scale were charted every 6(th) hourly for 24 h postoperatively and followed-up till recovery from ICU. Student's t-test, Chi-square/Fisher's exact test has been used to find the significance of study parameters between the groups.
RESULTS
Dexmedetomidine treated patients had significantly less VAS score at each level (P < 0.001). Total fentanyl consumption in dexmedetomidine group was 128.13 ± 35.78 μg versus 201.56 ± 36.99 μg in saline group (P < 0.001). A statistically significant but clinically unimportant sedation was noted at 6 and 12 h (P < 0.001, and P = 0.046 respectively). Incidence of delirium was less in dexmedetomidine group (P = 0.086+). Hemodynamic parameters were statistically insignificant.
CONCLUSIONS
Dexmedetomidine infusion even without loading dose provides safe, effective adjunct analgesia, reduces narcotic consumption, and showed a reduced trend of delirium incidence without undesirable hemodynamic effects in the cardiac surgery patients.",2015,"RESULTS
Dexmedetomidine treated patients had significantly less VAS score at each level (P < 0.001).","['postoperative analgesia following cardiac surgery', 'cardiac surgery patients', 'postcardiac surgery patients', 'single tertiary care hospital on patients posted for elective cardiac surgery under cardiopulmonary bypass']","['elective cardiac surgery under general anesthesia were shifted to intensive care unit (ICU', '12 h infusion of normal saline', 'Dexmedetomidine', 'dexmedetomidine']","['Total fentanyl consumption, hemodynamic monitoring, Visual Analogue Scale (VAS) pain ratings, Ramsay Sedation Scale', 'VAS score', 'Postoperative pain', 'Total fentanyl consumption', 'Hemodynamic parameters', 'analgesic efficacy', 'Incidence of delirium', 'clinically unimportant sedation', 'narcotic consumption']","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic Monitoring'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}]",64.0,0.340231,"RESULTS
Dexmedetomidine treated patients had significantly less VAS score at each level (P < 0.001).","[{'ForeName': 'Shio', 'Initials': 'S', 'LastName': 'Priye', 'Affiliation': 'Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sathyanarayan', 'Initials': 'S', 'LastName': 'Jagannath', 'Affiliation': 'Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Dipali', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shivaprakash', 'Affiliation': 'Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Durga Prasad', 'Initials': 'DP', 'LastName': 'Reddy', 'Affiliation': 'Department of Cardiac Anaesthesiology, Vydehi Institute of Medical Sciences, Bengaluru, Karnataka, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154715']
1846,32415684,"Clopidogrel, a CYP2C8 inhibitor, causes a clinically relevant increase in the systemic exposure to the active metabolite of selexipag in healthy subjects.","AIMS
Selexipag is a prostacyclin receptor agonist approved for the treatment of pulmonary arterial hypertension. Cytochrome P450 (CYP) 2C8 is involved in the metabolism of selexipag and its active metabolite, ACT-333679. This study evaluated the interaction of selexipag and clopidogrel, a CYP2C8 inhibitor.
METHODS
The study had a 2-treatment, 1-sequence, crossover design. Pharmacokinetics (PK) and CYP2C8 genotype were assessed in healthy male subjects administered selexipag (200 μg twice daily [b.i.d.]) alone or with clopidogrel (300 mg single dose or 75 mg once daily [o.d.]). PK modelling and simulation were conducted to support dosing recommendations.
RESULTS
Clopidogrel had a comparatively small effect on selexipag (<1.5-fold difference in any PK variable). For ACT-333679, the major contributor to the drug effect, the area under the plasma concentration-time curve during a dose interval and the maximum plasma concentration increased 2.25-fold (90% confidence interval [CI] 2.06, 2.46) and 1.69-fold (90% CI 1.55, 1.84), respectively with clopidogrel 300 mg and 2.70-fold (90% CI 2.45, 2.96) and 1.90-fold (90% CI 1.72, 2.11), respectively with clopidogrel 75 mg. The effect of clopidogrel on selexipag and ACT-333679 exposure was comparable for all identified CYP2C8 genotypes. PK simulations predicted comparable exposure to ACT-333679 following selexipag 400 μg b.i.d., 400 μg o.d. in combination with clopidogrel 75 mg o.d and 200 μg b.i.d. with clopidogrel 75 mg o.d.
CONCLUSION
Results suggest that ACT-333679 exposure can be maintained within the therapeutic range by reducing selexipag dosing frequency to o.d. or dose to half, when selexipag is coadministered with clopidogrel.",2020,The effect of clopidogrel on selexipag and ACT-333679 exposure was comparable for all identified CYP2C8 genotypes.,"['pulmonary arterial hypertension', 'healthy male subjects administered', 'healthy subjects']","['selexipag', 'selexipag and clopidogrel, a CYP2C8 inhibitor', 'clopidogrel', 'clopidogrel 75 mg o.d', 'Clopidogrel']","['Pharmacokinetics (PK) and CYP2C8 genotype', 'maximum plasma concentration (C max ', 'plasma concentration-time curve', 'selexipag']","[{'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2000145', 'cui_str': 'selexipag'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C3850061', 'cui_str': 'P450 CYP2C8 Inhibitors'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1382144', 'cui_str': 'Cytochrome p450 CYP2C8 enzyme'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C2000145', 'cui_str': 'selexipag'}]",,0.0966444,The effect of clopidogrel on selexipag and ACT-333679 exposure was comparable for all identified CYP2C8 genotypes.,"[{'ForeName': 'Lene Nygaard', 'Initials': 'LN', 'LastName': 'Axelsen', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Poggesi', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'Rasschaert', 'Affiliation': 'Clinical Pharmacology Unit, Janssen Pharmaceutica NV, Merksem, Belgium.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Perez Ruixo', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Bruderer', 'Affiliation': 'Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14365']
1847,32492377,Impact of submucosal saline solution injection for cold snare polypectomy of small colorectal polyps: a randomized controlled study.,"BACKGROUND AND AIMS
Cold snare polypectomy (CSP) of small colorectal polyps is widely used. However, the technique is still troubled with insufficient resection depth, which may prevent precise pathological evaluation. In this study, we investigated whether submucosal injection of saline solution helps to achieve deeper resection in CSP.
METHODS
The study was a single center, prospective, randomized trial (UMIN000037980). Patients with small (3-10 mm diameter) nonpedunculated adenomatous or sessile serrated colorectal polyps were randomly allocated to either conventional CSP (C-CSP) or CSP with submucosal injection (CSP-SI). Primary outcome was the rate of complete muscularis mucosae (MM) resection, defined by the proportion of MM under the tumor more than 80% of the tumor's horizontal dimension. Secondary outcomes were the rates of negative lateral and vertical margins, fragmentation of resected specimens, conversion to hot-snare mucosal resection, intraprocedural bleeding, delayed bleeding, and perforation.
RESULTS
Two hundred fourteen patients were randomly assigned to CSP-SI (n=107) or C-CSP (n=107). The rate of complete MM resection was 43.9% in the CSP-SI group and 53.3% in the C-CSP group, a statistically insignificant difference. The rates of negative lateral margin and vertical margin (42.3% and 56.7%, respectively) in the CSP-SI group were significantly lower than those (58% and 76%) in the C-CSP group (p=0.03 and p=0.006, respectively). There was no polypectomy-related major bleeding or perforation.
CONCLUSIONS
Saline solution injection into the submucosa did not improve the resection depth of CSP of small colorectal polyps, and the method resulted in lower rates of negative lateral and vertical margins of resected lesions.",2020,"The rates of negative lateral margin and vertical margin (42.3% and 56.7%, respectively) in the CSP-SI group were significantly lower than those (58% and 76%) in the C-CSP group (p=0.03 and p=0.006, respectively).","['Patients with small (3-10 mm diameter) nonpedunculated adenomatous or sessile serrated colorectal polyps', 'cold snare polypectomy of small colorectal polyps', 'Two hundred fourteen patients']","['saline solution', 'conventional CSP (C-CSP) or CSP with submucosal injection (CSP-SI', 'Cold snare polypectomy (CSP', 'submucosal saline solution injection', 'CSP-SI']","['rate of complete MM resection', 'rates of negative lateral margin and vertical margin', 'rates of negative lateral and vertical margins, fragmentation of resected specimens, conversion to hot-snare mucosal resection, intraprocedural bleeding, delayed bleeding, and perforation', 'resection depth of CSP of small colorectal polyps', ""rate of complete muscularis mucosae (MM) resection, defined by the proportion of MM under the tumor more than 80% of the tumor's horizontal dimension"", 'polypectomy-related major bleeding or perforation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0225357', 'cui_str': 'Muscularis mucosae'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0183362', 'cui_str': 'Snare'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",214.0,0.14452,"The rates of negative lateral margin and vertical margin (42.3% and 56.7%, respectively) in the CSP-SI group were significantly lower than those (58% and 76%) in the C-CSP group (p=0.03 and p=0.006, respectively).","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Shimodate', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan. Electronic address: ys13544@kchnet.or.jp.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Itakura', 'Affiliation': 'Department of Pathology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takayama', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Rio', 'Initials': 'R', 'LastName': 'Takezawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nishimura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Mouri', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Sunami', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Hirai', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Shumpei', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Muneaki', 'Initials': 'M', 'LastName': 'Miyake', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Matsueda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Kurashiki Clinical Research Institute, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Motowo', 'Initials': 'M', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.039']
1848,32492577,Associations Between Food Insecurity and Parental Feeding Behaviors of Toddlers.,"OBJECTIVES
We examined associations between household food insecurity status and parental feeding behavior, weight perception, and child weight status in a diverse sample of young children.
METHODS
Cross-sectional analysis of 2-year old children in Greenlight, a cluster randomized trial to prevent childhood obesity. The exposure was food insecurity, defined as a positive response to a validated screen. Outcomes were parent feeding behaviors/beliefs measured by the Child Feeding Questionnaire and child weight status. T-tests and linear regression were used to assess associations between food insecurity and each outcome. We adjusted for child sex, race/ethnicity, parent education, employment, site, number of children in the home, and WIC status.
RESULTS
503 households (37%) were food insecure. After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, p=0.01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; p=0.02). No differences were observed in monitoring or restrictive feeding behaviors. After adjusting for covariates, there was no difference in weight status or prevalence of overweight/obesity of children or parents based on household food insecurity status.
CONCLUSIONS
Parents from food insecure households reported more pressuring feeding behaviors. This finding underscores the need to address food insecurity and potentially prevent harmful effects on child feeding. Parents in food insecure households might benefit from linkage with resources and education to develop healthier feeding behaviors.",2020,"After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, p=0.01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; p=0.02).","['503 households (37%) were food insecure', '2-year old children in Greenlight, a cluster randomized trial to prevent childhood obesity', 'Toddlers']",[],"['pressuring feeding behaviors', 'monitoring or restrictive feeding behaviors', 'weight status or prevalence of overweight/obesity', 'feeding behaviors/beliefs measured by the Child Feeding Questionnaire and child weight status']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]",[],"[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",503.0,0.0299764,"After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, p=0.01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; p=0.02).","[{'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Orr', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina at Chapel, 260 MacNider CB #7220 Chapel Hill, NC 27514. Electronic address: colin_orr@med.unc.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Ravanbakht', 'Affiliation': 'Department of Pediatrics and Duke Center for Childhood Obesity Research, Duke University School of Medicine; 2213 Elba Street, Durham, NC 27705. Electronic address: snravan@email.unc.edu.'}, {'ForeName': 'Kori B', 'Initials': 'KB', 'LastName': 'Flower', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina at Chapel, 260 MacNider CB #7220 Chapel Hill, NC 27514. Electronic address: flower@email.unc.edu.'}, {'ForeName': 'H Shonna', 'Initials': 'HS', 'LastName': 'Yin', 'Affiliation': 'Department of Pediatrics and Department of Population Health; New York University School of Medicine 550 First Avenue New York, NY 10016. Electronic address: yinh02@med.nyu.edu.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': 'Division of General and Internal Medicine, Department of Medicine Vanderbilt University Medical Center, 2525 West End Ave, Suite 100, Nashville, Tennessee 37203; Center for Health Services Research, Vanderbilt University Medical Center, 2525 West End Ave, Suite 100, ashville, Tennessee 37203. Electronic address: russell.rothman@vanderbilt.edu.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Sanders', 'Affiliation': 'General Pediatrics, Department of Pediatrics, Stanford University of School of Medicine, 117 Encina Commons Room 182, Stanford, California 94305. Electronic address: lsanders@stanford.edu.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Delamater', 'Affiliation': 'Mailman Center for Child Development, University of Miami Miller School of Medicine. Electronic address: adelamater@med.miami.edu.'}, {'ForeName': 'Eliana M', 'Initials': 'EM', 'LastName': 'Perrin', 'Affiliation': 'Department of Pediatrics and Duke Center for Childhood Obesity Research, Duke University School of Medicine; 2213 Elba Street, Durham, NC 27705. Electronic address: Eliana.perrin@duke.edu.'}]",Academic pediatrics,['10.1016/j.acap.2020.05.020']
1849,27375386,Comparison of erythromycin versus metoclopramide for gastric feeding intolerance in patients with traumatic brain injury: A randomized double-blind study.,"BACKGROUND
No randomized controlled trial demonstrates the efficacy of erythromycin or metoclopramide in patients with traumatic brain injury (TBI). This study was conducted to determine the efficacy of metoclopramide and erythromycin for improving gastric aspirate volume (GAV) in patients with TBI.
MATERIALS AND METHODS
Patients with Glasgow coma score more than 5 admitted to trauma Intensive Care Unit within 72 h of head injury were assessed for eligibility. 115 patients were prospectively randomized to receive metoclopramide, erythromycin, or placebo eighth hourly. Gastric feeding intolerance was defined as GAV more than 150 ml with abdominal symptoms. Two consecutive high GAV was defined as feeding failure. Feeding failure was treated by increasing the frequency of dose to 6 hourly in metoclopramide and erythromycin group. Combination therapy with both drugs was given as rescue in the placebo group.
RESULTS
Incidence of high GAV was as high as 60.5% in placebo group. Use of erythromycin was associated with a decrease in the incidence of feeding intolerance to 28.9% (P = 0.006). Although feed intolerance decreased to 43.6% in metoclopramide group, values did not reach statistical significance. The proportion of patients not having high GAV at different days were significantly higher in erythromycin group (P = 0.027, log-rank test). There was no difference in the proportion of patients not having feeding failure in three groups with increasing number of days.
CONCLUSION
There was a significant decrease in the incidence of high GAV with the use of erythromycin when compared to metoclopramide and placebo.",2016,Use of erythromycin was associated with a decrease in the incidence of feeding intolerance to 28.9% (P = 0.006).,"['patients with TBI', 'patients with traumatic brain injury (TBI', 'Patients with Glasgow coma score more than 5 admitted to trauma Intensive Care Unit within 72 h of head injury were assessed for eligibility', 'patients with traumatic brain injury', '115 patients']","['metoclopramide, erythromycin, or placebo eighth hourly', 'metoclopramide', 'placebo', 'metoclopramide and erythromycin', 'erythromycin', 'erythromycin or metoclopramide']","['incidence of feeding intolerance', 'proportion of patients not having feeding failure', 'Gastric feeding intolerance', 'feed intolerance', 'incidence of high GAV', 'gastric aspirate volume (GAV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score finding'}, {'cui': 'C4047661', 'cui_str': 'Trauma ICU'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0370199', 'cui_str': 'Aspirate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",115.0,0.203186,Use of erythromycin was associated with a decrease in the incidence of feeding intolerance to 28.9% (P = 0.006).,"[{'ForeName': 'Jeetinder Kaur', 'Initials': 'JK', 'LastName': 'Makkar', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Basanta', 'Initials': 'B', 'LastName': 'Gauli', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Kajal', 'Initials': 'K', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Yatinder Kumar', 'Initials': 'YK', 'LastName': 'Batra', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.174902']
1850,31509204,Effect of a Standard vs Enhanced Implementation Strategy to Improve Antibiotic Prescribing in Nursing Homes: A Trial Protocol of the Improving Management of Urinary Tract Infections in Nursing Institutions Through Facilitated Implementation (IMUNIFI) Study.,"Importance
Suspicion of urinary tract infection (UTI) is the major driver of overuse and misuse of antibiotics in nursing homes (NHs). Effects of interventions to improve the recognition and management of UTI in NHs have been mixed, potentially owing to differences in how interventions were implemented in different studies. An improved understanding of how implementation approach influences intervention adoption is needed to achieve wider dissemination of antibiotic stewardship interventions in NHs.
Objective
To compare the effects of 2 implementation strategies on the adoption and effects of a quality improvement toolkit to enhance recognition and management of UTIs in NHs.
Design, Setting, and Participants
This cluster-randomized hybrid type 2 effectiveness-implementation clinical trial will be performed over a 6-month baseline (January to June 2019) and 12-month postimplementation period (July 2019 to June 2020). A minimum of 20 Wisconsin NHs with 50 or more beds will be recruited and randomized in block sizes of 2 stratified by rurality (rural vs urban). All residents who are tested and/or treated for UTI in study NHs will be included in the analysis. All study NHs will implement a quality improvement toolkit focused on enhancing the recognition and management of UTIs. Facilities will be randomized to either a usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback. Enhanced implementation is hypothesized to be associated with improvements in adoption of the quality improvement toolkit and clinical outcomes. Primary outcomes of the study will include number of (1) urine cultures per 1000 resident days and (2) antibiotic prescriptions for treatment of suspected UTI per 1000 resident-days. Secondary outcomes of the study will include appropriateness of UTI treatments, treatment length, use of fluoroquinolones, and resident transfers and mortality. A mixed-methods evaluation approach will be used to assess extent and determinants of adoption of the UTI quality improvement toolkit in study NHs.
Discussion
Knowledge gained during this study could help inform future efforts to implement antibiotic stewardship and quality improvement interventions in NHs.
Trial Registration
ClinicalTrials.gov identifier: NCT03520010.",2019,"Facilities will be randomized to either a usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback.","['Nursing Homes', 'UTIs in NHs', '20 Wisconsin NHs with 50 or more beds will be recruited and randomized in block sizes of 2 stratified by rurality (rural vs urban', 'All residents who are tested and/or treated for UTI in study NHs will be included in the analysis']","['usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback']","['Antibiotic', 'appropriateness of UTI treatments, treatment length, use of fluoroquinolones, and resident transfers and mortality', 'number of (1) urine cultures per 1000 resident days and (2) antibiotic prescriptions']","[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0430404', 'cui_str': 'Urine culture (procedure)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",,0.108839,"Facilities will be randomized to either a usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback.","[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'School of Pharmacy, University of Wisconsin, Madison.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Vranas', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin, Madison.'}, {'ForeName': 'DaRae', 'Initials': 'D', 'LastName': 'Coughlin', 'Affiliation': 'Center for Health Systems Research and Analysis, University of Wisconsin, Madison.'}, {'ForeName': 'Kathi M', 'Initials': 'KM', 'LastName': 'Selle', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin, Madison.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Nordman-Oliveira', 'Affiliation': 'Center for Health Systems Research and Analysis, University of Wisconsin, Madison.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Ryther', 'Affiliation': 'Center for Health Systems Research and Analysis, University of Wisconsin, Madison.'}, {'ForeName': 'Tola', 'Initials': 'T', 'LastName': 'Ewers', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin, Madison.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Griffin', 'Affiliation': 'Wisconsin Department of Health Services, Division of Quality Assurance, Bureau of Education Services & Technology, Madison.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eslinger', 'Affiliation': 'Marshfield Medical Center, Eau Claire, Wisconsin.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Boero', 'Affiliation': 'Wisconsin Healthcare-Associated Infections in Long-Term Care Coalition, Madison.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Hardgrove', 'Affiliation': 'Aurora Health Care, West Allis, Wisconsin.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Crnich', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin, Madison.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9526']
1851,32492824,A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study.,"BACKGROUND
Our aim was to understand cancer survivor needs prior to, and following the Alberta Cancer Exercise (ACE) pilot randomized trial as a means to inform implementation of a province-wide cancer-specific, community-based exercise program.
METHODS
Questionnaires and semi-structured stakeholder engagement sessions were conducted with cancer survivors to explore preferences, barriers and facilitators/benefits at two timepoints: (1) pre-ACE: prior to initiation of the ACE pilot trial ( n = 13 survivors and n = 5 caregivers); and (2) post-ACE: following participation in the ACE pilot trial ( n = 20 survivors). Descriptive statistics were used to summarize quantitative data from questionnaires. Stakeholder engagement data were analyzed using a framework analysis approach. Emergent themes were then mapped to actionable outcomes.
RESULTS
Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible. Post-ACE, participants identified (1) a lack of exercise counseling from health care providers, (2) the need for earlier introduction of exercise in the care pathway, and (3) supported referral to exercise programming.
CONCLUSIONS
An integrated knowledge translation approach identified actionable outcomes to address survivor needs related to exercise in clinical cancer and community-based contexts.",2020,"Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible.",[],['Questionnaires and semi-structured stakeholder engagement sessions'],[],[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4704677', 'cui_str': 'Stakeholder Engagement'}]",[],,0.0432749,"Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible.","[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Suderman', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Dolgoy', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Yurick', 'Affiliation': 'Cross Cancer Institute, Alberta Health Services, 11560 University Avenue, Edmonton, AB T6G 1Z2, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sellar', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Culos-Reed', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, 2500 University Drive NW, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Anil A', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Cross Cancer Institute, Alberta Health Services, 11560 University Avenue, Edmonton, AB T6G 1Z2, Canada.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNeely', 'Affiliation': 'Department of Physical Therapy, University of Alberta, 2-50 Corbett Hall, Edmonton, AB T6G 2G4, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17113911']
1852,32416157,Effects of high and low sucrose-containing beverages on blood glucose and hypoglycemic-like symptoms.,"BACKGROUND AND AIMS
There is this intriguing but not yet well-explored suggestion that highly absorbable sucrose-sweetened drinks might exacerbate hunger by promoting temporal hypoglycemia-like responses already in non-diabetic healthy individuals. This might provide a possible additional explanatory mechanism for previous reported associations between consumption of sugar-sweetened drinks and body weight gain. The current study involves two separate and independently conducted human experiments exploring the effects of two different single-doses of sugar-sweetened beverages on temporal blood glucose nadir and possible related behavioral hypoglycemic-like symptoms in healthy participants.
METHODS
By way of two separately conducted between-subjects experiments, effects of 1) a low (29 g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80 g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2) were measured on changes in blood glucose, behavioral hypoglycemia, appetite and mood.
RESULTS
Experiment-1: The 29 g sucrose containing beverage caused a high (37%) glycemic increase and a smaller response (15%) to the milk drink, which both peaked 30 min after consumption, whereas the sweetened zero-energy drink had very little effect on blood glucose. Regardless of the different magnitude of peak glycemic responses, both the sugar and milk drinks rather equally caused blood glucose concentrations to return to normal and stable baseline values 90 min later. There were no (different) effects of the beverages on behavioral hypoglycemic-like symptoms, appetite or mood. Experiment-2: the 80 g sucrose containing beverage caused a large (72%) glycemic peak response at +30 min after consumption, whereas neither the sweetened zero-energy nor the non-sweetened colored water drink had any meaningful effect on blood glucose. After intake of the 80 g sugar beverage, blood glucose concentrations remained elevated (13%) at +120 min and returned to lower baseline values in the direction of hypoglycemia levels at +165 min. There were no (differential) effects of the beverages on behavioral hypoglycemic symptoms, appetite or mood.
CONCLUSIONS
The current findings indicate that instead of a low (29 g) sugar-containing beverage, a high (80 g) sugar-containing beverage caused blood glucose concentrations to fall below baseline values almost reaching hypoglycemia levels at the end of measurements. There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165 min after consumption. Since this might include that in particular consumption of high-glycemic index drinks could still promote symptoms in the longer run, further research is needed to explore possible hypoglycemic-like effects of high dosages of sugar-sweetened beverages across more extended/delayed time measurements.",2020,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"['healthy participants', 'Experiment-1', 'Experiment-2']","['high and low sucrose-containing beverages', 'low (29g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2', 'sugar-sweetened beverages']","['blood glucose, behavioral hypoglycemia, appetite and mood', 'behavioral hypoglycemic-like symptoms, appetite or mood', 'blood glucose', 'glycemic peak response', 'blood glucose and hypoglycemic-like symptoms', 'hypoglycemic-like behavioral symptoms including changes in appetite or mood', 'blood glucose concentrations', 'behavioral hypoglycemic symptoms, appetite or mood', 'temporal blood glucose nadir']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",,0.0416675,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"[{'ForeName': 'C Rob', 'Initials': 'CR', 'LastName': 'Markus', 'Affiliation': 'University Maastricht, Faculty of Psychology and Neuroscience; Dept of Neuropsychology & Psychopharmacology, Maastricht, Netherlands.. Electronic address: r.markus@maastrichtuniversity.nl.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, UK.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112916']
1853,31561727,Prospective Randomized Trial Comparing Mobile-Bearing and Fixed-Bearing Total Ankle Replacement.,"BACKGROUND
Outcomes of total ankle replacement for the treatment of end-stage ankle arthritis continue to improve. Debate continues whether a mobile-bearing total ankle replacement (MB-TAR) or a fixed-bearing total ankle replacement (FB-TAR) is superior, with successful outcomes reported long term for MB-TAR and at intermediate- to long-term follow-up for newer generation FB-TAR. Although comparisons between the 2 total ankle designs have been reported, to our knowledge, no investigation has compared the 2 designs with a high level of evidence. This prospective, randomized controlled trial conducted at a single institution compares patient satisfaction, functional outcomes, and radiographic results of the mobile-bearing STAR and the fixed-bearing Salto-Talaris in the treatment of end-stage ankle arthritis.
METHODS
Between November 2011 and November 2014, adult patients with end-stage ankle osteoarthritis failing nonoperative treatment were introduced to the study. With informed consent, 100 patients (31 male and 69 female, average age 65 years, range 35-85 years) were enrolled; a demographic comparison between the 2 cohorts was similar. Exclusion criteria included inflammatory arthropathy, neuropathy, weight exceeding 250 pounds, radiographic coronal plane deformity greater than 15 degrees, or extensive talar dome wear pattern (""flat-top talus""). Prospective patient-reported outcomes, physical examination, and standardized weightbearing ankle radiographs were obtained preoperatively, at 6 and 12 months postoperatively, and then at yearly intervals. Data collection included visual analog pain score, Short Form 36, Foot and Ankle Disability Index, Short Musculoskeletal Functional Assessment, and American Orthopaedic Foot & Ankle Society ankle-hindfoot score. Surgeries were performed by a nondesign team of orthopedic foot and ankle specialists with total ankle replacement expertise. Statistical analysis was performed by a qualified statistician. At average follow-up of 4.5 years (range, 2-6 years) complete clinical data and radiographs were available for 84 patients; 7 had incomplete data, 1 had died, 4 were withdrawn after enrolling but prior to surgery, and 4 were lost to follow-up.
RESULTS
In all outcome measures, the entire cohort demonstrated statistically significant improvements from preoperative evaluation to most recent follow-up with no statistically significant difference between the 2 groups. Radiographically, tibial lucency/cyst formation was 26.8% and 20.9% for MB-TAR and FB-TAR, respectively. Tibial settling/subsidence occurred in 7.3% of MB-TAR. Talar lucency/cyst formation occurred in 24.3% and 2.0% of MB-TAR and FB-TAR, respectively. Talar subsidence was observed in 21.9% and 2.0% of MB-TAR and FH-TAR, respectively. Reoperations were performed in 8 MB-TARs and 3 FH-TARs, with the majority of procedures being to relieve impingement or treat cysts and not to revise or remove metal implants.
CONCLUSION
With a high level of evidence, our study found that patient-reported and clinical outcomes were favorable for both designs and that there was no significant difference in clinical improvement between the 2 implants. The incidence of lucency/cyst formation was similar for MB-TAR and FH-TAR for the tibial component, but the MB-TAR had greater talar lucency/cyst formation and tibial and talar subsidence. As has been suggested in previous studies, clinical outcomes do not necessarily correlate with radiographic findings. Reoperations were more common for MB-TAR and, in most cases, were to relieve impingement or treat cysts rather than revise or remove metal implants.
LEVEL OF EVIDENCE
Level I, prospective randomized study.",2019,"The incidence of lucency/cyst formation was similar for MB-TAR and FH-TAR for the tibial component, but the MB-TAR had greater talar lucency/cyst formation and tibial and talar subsidence.","['Between November 2011 and November 2014', 'Exclusion criteria included inflammatory arthropathy, neuropathy, weight exceeding 250 pounds, radiographic coronal plane deformity greater than 15 degrees, or extensive talar dome wear pattern (""flat-top talus', 'adult patients with end-stage ankle osteoarthritis failing nonoperative treatment', '100 patients (31 male and 69 female, average age 65 years, range 35-85 years']","['Mobile-Bearing and Fixed-Bearing Total Ankle Replacement[Formula', 'total ankle replacement']","['clinical improvement', 'Talar subsidence', 'Radiographically, tibial lucency/cyst formation', 'visual analog pain score, Short Form 36, Foot and Ankle Disability Index, Short Musculoskeletal Functional Assessment, and American Orthopaedic Foot & Ankle Society ankle-hindfoot score', 'Talar lucency/cyst formation', 'talar lucency/cyst formation and tibial and talar subsidence', 'incidence of lucency/cyst formation', 'Tibial settling/subsidence']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C4551585', 'cui_str': 'Frontal plane'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0444914', 'cui_str': 'Domed (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0039277', 'cui_str': 'Astragalus Bone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0409931', 'cui_str': 'Osteoarthritis of ankle (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0188664', 'cui_str': 'Arthroplasty, Replacement, Ankle'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot (body structure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1266099', 'cui_str': 'Spindle epithelial tumor with thymus-like element'}]",100.0,0.0965881,"The incidence of lucency/cyst formation was similar for MB-TAR and FH-TAR for the tibial component, but the MB-TAR had greater talar lucency/cyst formation and tibial and talar subsidence.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Nunley', 'Affiliation': 'Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery, Duke University Health System, Durham, NC, USA.'}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Adams', 'Affiliation': 'Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery, Duke University Health System, Durham, NC, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Easley', 'Affiliation': 'Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery, Duke University Health System, Durham, NC, USA.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'DeOrio', 'Affiliation': 'Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery, Duke University Health System, Durham, NC, USA.'}]",Foot & ankle international,['10.1177/1071100719879680']
1854,31127757,"Effects of resistive jaw opening exercise in stroke patients with dysphagia: A double- blind, randomized controlled study.","BACKGROUND
The resistive jaw opening exercise (RJOE) was suggested as a potential remedial treatment for patients with dysphagia. However, clinical evidence is insufficient.
OBJECTIVE
To investigate the effect of RJOE on hyoid bone movement, aspiration, and oral intake level in stroke patients with dysphagia.
METHODS
Forty stroke patients with dysphagia were randomly allocated into either the experimental group (n= 20) or placebo group (n= 20). The experimental group performed RJOE using a portable device, while the placebo group performed RJOE using a sham device with fewer loads. Intervention was conducted 5 times a week for 4 weeks. Hyoid bone movement was analyzed by two-dimensional analysis of anterior and superior motion based on a videofluoroscopic swallowing study. Aspiration was assessed using a penetration-aspiration scale (PAS), and oral intake level was assessed using the functional oral intake scale (FOIS).
RESULTS
Both groups showed statistically significant differences in hyoid movement, PAS, and FOIS scale (p< 0.05). However, after the intervention, there was no significant difference between the two groups except for the liquid type of PAS. Effect sizes (Cohen's d) were 0.9 and 0.7, 0.6 and 0.6, and 1.1 for the anterior and superior movement of the hyoid bone, semisolid and liquid type of PAS, and FOIS scale respectively.
CONCLUSIONS
This study suggests that RJOE helps in hyoid movement, aspiration reduction, and oral intake in patients with dysphagia after stroke.",2020,"Both groups showed statistically significant differences in hyoid movement, PAS, and FOIS scale (p< 0.05).","['Forty stroke patients with dysphagia', 'patients with dysphagia', 'stroke patients with dysphagia', 'patients with dysphagia after stroke']","['resistive jaw opening exercise (RJOE', 'RJOE', 'placebo', 'resistive jaw opening exercise']","['Hyoid bone movement', 'hyoid movement, PAS, and FOIS scale', 'penetration aspiration scale (PAS), and oral intake level', 'hyoid bone movement, aspiration, and oral intake level', 'liquid type of PAS', 'hyoid bone, semisolid and liquid type of PAS, and FOIS scale respectively', 'functional oral intake scale (FOIS']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0020417', 'cui_str': 'Lingual Bone'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0222045'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",40.0,0.152171,"Both groups showed statistically significant differences in hyoid movement, PAS, and FOIS scale (p< 0.05).","[{'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan, Korea.'}, {'ForeName': 'Duk-Hyun', 'Initials': 'DH', 'LastName': 'An', 'Affiliation': 'Department of Physical Therapy, College of Healthcare Medical Science and Engineering, Inje University, Gimhae, Korea.'}, {'ForeName': 'Kyung-Yoon', 'Initials': 'KY', 'LastName': 'Kam', 'Affiliation': 'Department of Occupational Therapy, College of Healthcare Medical Science and Engineering, Inje University, Gimhae, Korea.'}, {'ForeName': 'Taehyung', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Department of Occupational Therapy, Division of Health Sciences, Dongseo University, Busan, Korea.'}, {'ForeName': 'Taehoon', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Division of Health Sciences, Dongseo University, Busan, Korea.'}, {'ForeName': 'Moon-Young', 'Initials': 'MY', 'LastName': 'Chang', 'Affiliation': 'Department of Occupational Therapy, College of Healthcare Medical Science and Engineering, Inje University, Gimhae, Korea.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181477']
1855,27063626,Assessing the impact of multiple sclerosis disease activity and daclizumab HYP treatment on patient-reported outcomes: Results from the SELECT trial.,"BACKGROUND
The SELECT study demonstrated superior effects of daclizumab high-yield process (DAC HYP) to placebo in key endpoints in patients with relapsing and remitting multiple sclerosis (RRMS).
OBJECTIVE
To assess the impact of DAC HYP and disease activity on health-related quality of life (HRQoL) using data from this study.
METHODS
HRQoL was assessed at baseline, 12, 24, and 52 weeks using the Multiple Sclerosis Impact Scale (MSIS-29), the 12-items Short Form Health Survey, and the EuroQoL-5 Dimensions. An analysis of covariance model was used to compare treatment difference in change from baseline. Mixed-effects models were used to assess the impact of disability progression, relapse, treatment, and interaction between treatment and these events on HRQoL outcome.
RESULTS
DAC HYP 150mg resulted in significant positive impacts on HRQoL compared to placebo. It was also found to significantly reduce the adverse impact of relapse on the MSIS-29 physical scale (-12.45; p=0.0006). Relapse and disability progression were significantly associated with impaired HRQoL.
CONCLUSION
DAC HYP 150mg improved HRQoL in patients with RRMS compared to placebo. The treatment benefit can be partially attributed to reduction in disease activity and attenuation of the adverse impact of relapse on HRQoL.",2016,It was also found to significantly reduce the adverse impact of relapse on the MSIS-29 physical scale (-12.45; p=0.0006).,"['patients with relapsing and remitting multiple sclerosis (RRMS', 'patient-reported outcomes']","['daclizumab HYP treatment', 'placebo', 'daclizumab']","['adverse impact of relapse on the MSIS-29 physical scale', 'HRQoL', 'health-related quality of life (HRQoL', 'Multiple Sclerosis Impact Scale (MSIS-29), the 12-items Short Form Health Survey, and the EuroQoL-5 Dimensions', 'Relapse and disability progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]","[{'cui': 'C4042011', 'cui_str': 'daclizumab HYP'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0663182', 'cui_str': 'Daclizumab'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0994162,It was also found to significantly reduce the adverse impact of relapse on the MSIS-29 physical scale (-12.45; p=0.0006).,"[{'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Phillips', 'Affiliation': 'Biogen, 300 Binney Street, Cambridge, MA 02142, United States. Electronic address: Glenn.Phillips@biogen.com.'}, {'ForeName': 'Shien', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Evidera, 430 Bedford St. Suite 300 Lexington Office Park, Lexington, MA 02420, United States.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Bender', 'Affiliation': 'Evidera, 7101 Wisconsin Ave., Suite 1400, Bethesda, MD 20814 United States.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Havrdová', 'Affiliation': 'Charles University in Prague, Ovocný trh 3-5 Prague 1, 116 36, Prague, Czech Republic.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Proskorovsky', 'Affiliation': 'Evidera, 7575 Trans-Canada Highway Suite 500, St-Laurent, Quebec, Montreal, Canada H4T 1V6.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Vollmer', 'Affiliation': 'University of Colorado School of Medicine, Anschutz Medical Campus, Department of Neurology, Academic Office 1, Mail Stop B-185, 12631 East 17th Avenue, Aurora, CO 80045, United States.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2016.02.001']
1856,30015563,Passive stretching-induced changes detected during voluntary muscle contractions.,"Stretching exercises are known for reduction of musculoskeletal stiffness and elongation of electromechanical delay (EMD). However, computing a change in stiffness by means of time delays, detected between onset of electromyographic (EMG), mechanomyographic (MMG) and force signals, can reveal changes in subcomponents (Δ t EMG-MMG and Δ t MMG-FORCE) of EMD after stretching. In our study, the effect of stretching was investigated while quadriceps femoris (QF) muscle performed isometric contractions. The EMG, MMG, and Force signals were recorded from rectus femoris (RF) and vastus medialis (VM) during five voluntarily isometric contractions at 15°, 30°, and 45° of knee flexion angle, while the leg was positioned on a custom-made device. Subjects in both intervention and control groups underwent same recording procedure before and after stretching. No difference between the baseline repeated contractions (before stretching) was ensured by ANOVA for repeated measures while a difference between PRE and POST was analyzed and concluded based on the effect size results. The EMD did not change; however, subcomponents (Δ t EMG-MMG and Δ t MMG-FORCE) showed differences within RF and VM muscles after stretching. The 30° knee flexion angle appears to be a position where isometric contraction intensity needs to be carefully monitored during rehabilitation period.",2020,No difference between the baseline repeated contractions (before stretching) was ensured by ANOVA for repeated measures while a difference between PRE and POST was analyzed and concluded based on the effect size results.,[],['Stretching exercises'],"['onset of electromyographic (EMG), mechanomyographic (MMG) and force signals', 'EMG, MMG, and Force signals']",[],"[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",,0.0283855,No difference between the baseline repeated contractions (before stretching) was ensured by ANOVA for repeated measures while a difference between PRE and POST was analyzed and concluded based on the effect size results.,"[{'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Begovic', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Hacettepe University , Ankara, Turkey.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Can', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Hacettepe University , Ankara, Turkey.'}, {'ForeName': 'Suha', 'Initials': 'S', 'LastName': 'Yağcioğlu', 'Affiliation': 'Department of Biophysics, Faculty of Medicine, Hacettepe University , Ankara, Turkey.'}, {'ForeName': 'Necla', 'Initials': 'N', 'LastName': 'Ozturk', 'Affiliation': 'Department of Biophysics, Faculty of Medicine, Maltepe University , Istanbul, Turkey.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1491660']
1857,32416781,"Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND
Nivolumab and ipilimumab, alone or in combination, are widely used immunotherapeutic treatment options for patients with advanced-ie, unresectable or metastatic-melanoma. This criterion, however, excludes patients with stage IV melanoma with no evidence of disease. We therefore aimed to evaluate the safety and efficacy of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus a placebo in this patient population.
METHODS
We did a randomised, double-blind, placebo-controlled, phase 2 trial in 20 German academic medical centres. Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy. Key exclusion criteria included uveal or mucosal melanoma, previous therapy with checkpoint inhibitors, and any previous immunosuppressive therapy within the 30 days before study drug administration. Eligible patients were randomly assigned (1:1:1), using a central, interactive, online system, to the nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 mg/kg of nivolumab every 2 weeks), nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1-12), or double-matching placebo group. The primary endpoint was the recurrence-free survival in the intention-to-treat population. The results presented in this report reflect the prespecified interim analysis of recurrence-free survival after 90 events had been reported. This study is registered with ClinicalTrials.gov, NCT02523313, and is ongoing.
FINDINGS
Between Sept 2, 2015, and Nov 20, 2018, 167 patients were randomly assigned to receive nivolumab plus ipilimumab (n=56), nivolumab (n=59), or placebo (n=52). As of July 2, 2019, at a median follow-up of 28·4 months (IQR 17·7-36·8), median recurrence-free survival was not reached in the nivolumab plus ipilimumab group, whereas median recurrence-free survival was 12·4 months (95% CI 5·3-33·3) in the nivolumab group and 6·4 months (3·3-9·6) in the placebo group. The hazard ratio for recurrence for the nivolumab plus ipilimumab group versus placebo group was 0·23 (97·5% CI 0·12-0·45; p<0·0001), and for the nivolumab group versus placebo group was 0·56 (0·33-0·94; p=0·011). In the nivolumab plus ipilimumab group, recurrence-free survival at 1 year was 75% (95% CI 61·0-84·9) and at 2 years was 70% (55·1-81·0); in the nivolumab group, 1-year recurrence-free survival was 52% (38·1-63·9) and at 2 years was 42% (28·6-54·5); and in the placebo group, this rate was 32% (19·8-45·3) at 1 year and 14% (5·9-25·7) at 2 years. Treatment-related grade 3-4 adverse events were reported in 71% (95% CI 57-82) of patients in the nivolumab plus ipilimumab group and in 27% (16-40) of those in the nivolumab group. Treatment-related adverse events of any grade led to treatment discontinuation in 34 (62%) of 55 patients in the nivolumab plus ipilimumab group and seven (13%) of 56 in the nivolumab group. Three deaths from adverse events were reported but were considered unrelated to the study treatment.
INTERPRETATION
Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease. The rates of grade 3-4 treatment-related adverse events in both active treatment groups were higher than the rates reported in previous pivotal trials done in advanced melanoma with measurable disease.
FUNDING
Bristol-Myers Squibb.",2020,"INTERPRETATION
Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease.","['patients with resected stage IV melanoma with no evidence of disease (IMMUNED', '20 German academic medical centres', 'Between Sept 2, 2015, and Nov 20, 2018, 167 patients', 'patients with stage IV melanoma with no evidence of disease', 'Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy', 'patients with advanced-ie, unresectable or metastatic-melanoma', 'Eligible patients']","['nivolumab alone or in combination with ipilimumab', 'adjuvant nivolumab plus ipilimumab', 'nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo', 'nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab', 'nivolumab', 'nivolumab plus ipilimumab', 'Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo', 'placebo']","['Treatment-related grade 3-4 adverse events', 'rates of grade 3-4 treatment-related adverse events', 'hazard ratio for recurrence', 'safety and efficacy', 'recurrence-free survival', '1-year recurrence-free survival', 'median recurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",167.0,0.766829,"INTERPRETATION
Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zimmer', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Livingstone', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Hassel', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fluck', 'Affiliation': 'Department of Oncology Hornheide, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eigentler', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Haferkamp', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center Hannover, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Friedegund', 'Initials': 'F', 'LastName': 'Meier', 'Affiliation': 'Department of Dermatology, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Department of Dermatology, Elbe-Kliniken, Buxtehude, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Schilling', 'Affiliation': 'Department of Dermatology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Menzer', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kieker', 'Affiliation': 'Department of Dermatology, Charité Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Dippel', 'Affiliation': 'Department of Dermatology, Ludwigshafen Medical Center, Ludwigshafen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rösch', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jan-Christoph', 'Initials': 'JC', 'LastName': 'Simon', 'Affiliation': 'Department of Dermatology, Leipzig University Hospital Medical Center, Leipzig, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Conrad', 'Affiliation': 'Department of Oncology Hornheide, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Körner', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Windemuth-Kieselbach', 'Affiliation': 'Alcedis GmbH, Giessen, Germany.'}, {'ForeName': 'Leonora', 'Initials': 'L', 'LastName': 'Schwarz', 'Affiliation': 'Alcedis GmbH, Giessen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jürgen C', 'Initials': 'JC', 'LastName': 'Becker', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany; Translational Skin Cancer Research, German Cancer Consortium (DKTK), Partner Site Essen, Medical Faculty, University of Duisburg-Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30417-7']
1858,31639790,Efficacy of Oral Nicorandil to Prevent Contrast-Induced Nephropathy in Patients with Chronic Renal Dysfunction Undergoing an Elective Coronary Procedure.,"OBJECTIVES
This prospective, randomized study was to investigate the role of nicorandil in the prevention of contrast-induced nephropathy (CIN) in patients with chronic renal dysfunction undergoing an elective coronary procedure.
METHODS
A total of 252 eligible patients were enrolled in this study and allocated into the control group (n = 125) or nicorandil group (n = 127). Both groups received the standard hydration treatment, and patients in the nicorandil group were orally administrated 10 mg of nicorandil (t.i.d.) beginning 2 days before and continuing for 2 days after an elective coronary procedure. Serum creatinine (SCr) and cystatin C (CysC) were measured at 24 h before and 24, 48, and 72 h after the procedure. The occurrences of CIN and adverse events within 1 year were recorded.
RESULTS
The nicorandil group had relatively lower SCr and CysC levels and a higher eGFR at 24 and 48 h after the procedure than the control group (p < 0.05). The incidence of CIN was significantly decreased in the nicorandil group compared to the control group. The multivariate logistic regression model revealed that nicorandil treatment was an independent protective factor for CIN (OR 0.669, 95% CI 0.522-0.857, p = 0.001). The multivariate COX proportional hazard model showed that nicorandil treatment was an independent protective predictor for adverse events (HR 0.881, 95% CI 0.781-0.993, p = 0.037).
CONCLUSIONS
Nicorandil could exhibit a protective effect against CIN in patients with chronic renal dysfunction undergoing an elective coronary procedure and reduce the adverse events within 1 year after the procedure, which is superior to hydration treatment only.",2019,The nicorandil group had relatively lower SCr and CysC levels and a higher eGFR at 24 and 48 h after the procedure than the control group (p < 0.05).,"['Patients with Chronic Renal Dysfunction Undergoing an Elective Coronary Procedure', 'group (n = 127', 'patients with chronic renal dysfunction undergoing an elective coronary procedure', '252 eligible patients']","['Oral Nicorandil', 'Nicorandil', 'nicorandil', 'nicorandil group were orally administrated 10 mg of nicorandil', 'standard hydration treatment']","['SCr and CysC levels', 'adverse events', 'protective factor for CIN', 'occurrences of CIN and adverse events', 'Serum creatinine (SCr) and cystatin C (CysC', 'incidence of CIN']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",252.0,0.0433518,The nicorandil group had relatively lower SCr and CysC levels and a higher eGFR at 24 and 48 h after the procedure than the control group (p < 0.05).,"[{'ForeName': 'Zeyuan', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiovascular Diseases, Civil Aviation General Hospital, Civil Aviation Clinical Medical College of Peking University, Beijing, China, fanzy_mhzyy@163.com.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular Diseases, Civil Aviation General Hospital, Civil Aviation Clinical Medical College of Peking University, Beijing, China.'}, {'ForeName': 'Hanhua', 'Initials': 'H', 'LastName': 'Ji', 'Affiliation': 'Department of Cardiovascular Diseases, Civil Aviation General Hospital, Civil Aviation Clinical Medical College of Peking University, Beijing, China.'}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Jian', 'Affiliation': 'Department of Cardiovascular Diseases, Civil Aviation General Hospital, Civil Aviation Clinical Medical College of Peking University, Beijing, China.'}]",Kidney & blood pressure research,['10.1159/000503160']
1859,31543957,"Protocol for a factorial randomised controlled trial, embedded within WHiTE 8 COPAL, of an Enhanced Trainee Principal Investigator Package and Additional Digital Nudge to increase recruitment rates.","Recruitment remains an issue when conducting randomised controlled trials (RCTs) with a significant proportion of studies failing to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. This factorial RCT will evaluate the effectiveness of an educational intervention to trainee principal investigators and a positive reinforcement intervention via an email nudge on increasing recruitment. The targeted recruiters will be in 20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL. Centres will be randomised via minimisation to one of four groups. The primary outcome is recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model. Results will be presented as adjusted incidence rate ratios with 95% confidence intervals. Secondary outcomes relate to the feasibility and logistics of running the interventions. We will also collect feedback regarding the educational programme set out for the trainee principal investigators. The study started in August 2018 with the anticipation of the primary objective endpoint by October 2019. The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. Trial registration: 11600053, ISRCTN, 20/08/2018; SWAT 67, Northern Ireland Hub for Trials Methodology Research SWAT repository, 01/10/2017.",2019,"The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. ","['August 2018 with the anticipation of the primary objective endpoint by October 2019', '20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL']",[],"['feasibility and logistics of running the interventions', 'recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1564274', 'cui_str': 'Copal'}]",[],"[{'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",,0.326548,"The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. ","[{'ForeName': 'Nickil', 'Initials': 'N', 'LastName': 'Agni', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McDaid', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Reed', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Department of Health Sciences, University of York, UK, York, YO10 5DD, UK.'}]",F1000Research,['10.12688/f1000research.19743.1']
1860,32492168,A metabolomic study of red and processed meat intake and acylcarnitine concentrations in human urine and blood.,"BACKGROUND
Acylcarnitines (ACs) play a major role in fatty acid metabolism and are potential markers of metabolic dysfunction with higher blood concentrations reported in obese and diabetic individuals. Diet, and in particular red and processed meat intake, has been shown to influence AC concentrations but data on the effect of meat consumption on AC concentrations is limited.
OBJECTIVES
To investigate the effect of red and processed meat intake on AC concentrations in plasma and urine using a randomized controlled trial with replication in an observational cohort.
METHODS
In the randomized crossover trial, 12 volunteers successively consumed 2 different diets containing either pork or tofu for 3 d each. A panel of 44 ACs including several oxidized ACs was analyzed by LC-MS in plasma and urine samples collected after the 3-d period. ACs that were associated with pork intake were then measured in urine (n = 474) and serum samples (n = 451) from the European Prospective Investigation into Cancer and nutrition (EPIC) study and tested for associations with habitual red and processed meat intake derived from dietary questionnaires.
RESULTS
In urine samples from the intervention study, pork intake was positively associated with concentrations of 18 short- and medium-chain ACs. Eleven of these were also positively associated with habitual red and processed meat intake in the EPIC cross-sectional study. In blood, C18:0 was positively associated with red meat intake in both the intervention study (q = 0.004, Student's t-test) and the cross-sectional study (q = 0.033, linear regression).
CONCLUSIONS
AC concentrations in urine and blood were associated with red meat intake in both a highly controlled intervention study and in subjects of a cross-sectional study. Our data on the role of meat intake on this important pathway of fatty acid and energy metabolism may help understanding the role of red meat consumption in the etiology of some chronic diseases. This trial was registered at Clinicaltrials.gov as NCT03354130.",2020,"In blood, C18:0 was positively associated with red meat intake in both the intervention study (q = 0.004, Student's t-test) and the cross-sectional study (q = 0.033, linear regression).
","['12 volunteers successively consumed 2 different diets containing either pork or tofu for 3 d each', 'obese and diabetic individuals', 'human urine and blood']",['red and processed meat intake'],"['red meat intake', 'habitual red and processed meat intake', 'several oxidized ACs']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0452867', 'cui_str': 'Pork'}, {'cui': 'C0453233', 'cui_str': 'Tofu'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0556213', 'cui_str': 'Processed meat intake'}]","[{'cui': 'C0556202', 'cui_str': 'Red meat intake'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0556213', 'cui_str': 'Processed meat intake'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}]",12.0,0.0566447,"In blood, C18:0 was positively associated with red meat intake in both the intervention study (q = 0.004, Student's t-test) and the cross-sectional study (q = 0.033, linear regression).
","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wedekind', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Keski-Rahkonen', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Viallon', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Rothwell', 'Affiliation': 'Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cross', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Agnetha Linn', 'Initials': 'AL', 'LastName': 'Rostgaard-Hansen', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Torkjel M', 'Initials': 'TM', 'LastName': 'Sandanger', 'Affiliation': 'Department of Community Medicine, UiT the Arctic university of Norway, Tromsø, Norway.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Jakszyn', 'Affiliation': 'Unit of Nutrition and Cancer, Cancer Epidemiology Research Programme, Catalan Institute of Oncology, Barcelona, Spain.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmidt', 'Affiliation': 'Cancer Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Pala', 'Affiliation': 'Epidemiology and Prevention Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano,Italy.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Vermeulen', 'Affiliation': 'Division of Environmental Epidemiology, \xa0Institute for Risk Assessment Sciences, Utrecht University, \xa0Utrecht, The Netherlands.'}, {'ForeName': 'Matthias B', 'Initials': 'MB', 'LastName': 'Schulze', 'Affiliation': 'Department of Molecular Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Theron', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Trichopoulou', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Peppa', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'La Vechia', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Masala', 'Affiliation': 'Cancer Risk Factors and Life-Style\xa0Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO) , Florence, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Tumino', 'Affiliation': 'Cancer Registry and Histopathology Department, Provincial Health Authority (ASP) Ragusa, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Sacerdote', 'Affiliation': 'Unit of Cancer Epidemiology, Città della Salute e della Scienza University-Hospital and Center for Cancer Prevention (CPO), Turin, Italy.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Wittenbecher', 'Affiliation': 'Department of Molecular Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Maria Santucci', 'Initials': 'MS', 'LastName': 'de Magistris', 'Affiliation': 'Azienda Ospedialiera Universitaria (A.O.U.) Federico II, Naples, Italy.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Dahm', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Severi', 'Affiliation': 'Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France.'}, {'ForeName': 'Francesca Romana', 'Initials': 'FR', 'LastName': 'Mancini', 'Affiliation': 'Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France.'}, {'ForeName': 'Elisabete', 'Initials': 'E', 'LastName': 'Weiderpass', 'Affiliation': 'International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gunter', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Huybrechts', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Scalbert', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa140']
1861,32492186,Laparoscopic sentinel node navigation surgery versus laparoscopic gastrectomy with lymph node dissection for early gastric cancer: short-term outcomes of a multicentre randomized controlled trial (SENORITA).,"BACKGROUND
Sentinel node navigation surgery reduces the extent of gastric and lymph node dissection, and may improve quality of life. The benefit and harm of laparoscopic sentinel node navigation surgery (LSNNS) for early gastric cancer is unknown. The SENORITA (SEntinel Node ORIented Tailored Approach) trial investigated the pathological and surgical outcomes of LSNNS compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection.
METHODS
The SENORITA trial was an investigator-initiated, open-label, parallel-assigned, non-inferiority, multicentre RCT conducted in Korea. The primary endpoint was 3-year disease-free survival. The secondary endpoints, morbidity and mortality within 30 days of surgery, are reported in the present study.
RESULTS
A total of 580 patients were randomized to LSG (292) or LSNNS (288). Surgery was undertaken in 527 patients (LSG 269, LSNNS 258). LSNNS could be performed according to the protocol in 245 of 258 patients, and a sentinel node basin was detected in 237 (96·7 per cent) Stomach-preserving surgery was carried out in 210 of 258 patients (81·4 per cent). Postoperative complications occurred in 51 patients in the LSG group (19·0 per cent) and 40 (15·5 per cent) in the LSNNS group (P = 0·294). Complications with a Clavien-Dindo grade of III or higher occurred in 16 (5·9 per cent) and 13 (5·0 per cent) patients in the LSG and LSNNS groups respectively (P = 0·647).
CONCLUSION
The rate and severity of complications following LSNNS for early gastric cancer are comparable to those after LSG with lymph node dissection. Registration number: NCT01804998 ( http://www.clinicaltrials.gov).",2020,"LSNNS could be performed according to the protocol in 245 of 258 patients, and a sentinel node basin was detected in 237 (96·7 per cent) Stomach-preserving surgery was carried out in 210 of 258 patients (81·4 per cent).","['early gastric cancer', '580 patients', '527 patients (LSG 269, LSNNS 258']","['Laparoscopic sentinel node navigation surgery versus laparoscopic gastrectomy with lymph node dissection', 'laparoscopic sentinel node navigation surgery (LSNNS', 'LSNNS', 'laparoscopic standard gastrectomy (LSG', 'LSG']","['quality of life', 'sentinel node basin', '3-year disease-free survival', 'Postoperative complications', 'rate and severity of complications', 'morbidity and mortality']","[{'cui': 'C0349530', 'cui_str': 'Early gastric cancer'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0179226', 'cui_str': 'Basin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",580.0,0.284092,"LSNNS could be performed according to the protocol in 245 of 258 patients, and a sentinel node basin was detected in 237 (96·7 per cent) Stomach-preserving surgery was carried out in 210 of 258 patients (81·4 per cent).","[{'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'J-S', 'Initials': 'JS', 'LastName': 'Min', 'Affiliation': 'Departments of Surgery, Dongnam Institute of Radiological and Medical Sciences, Cancer Centre, Busan, South Korea.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hur', 'Affiliation': 'Ajou University School of Medicine, Suwon, South Korea.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Gyeongsang National University, Jinju, South Korea.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Cho', 'Affiliation': 'Soonchunhyang University College of Medicine, Bucheon, South Korea.'}, {'ForeName': 'Y-K', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Chonnam National University Medical School, Gwangju, South Korea.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Jung', 'Affiliation': 'Chonnam National University Medical School, Gwangju, South Korea.'}, {'ForeName': 'J-H', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Gyeongsang National University, Jinju, South Korea.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Hyung', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'S-H', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': 'Gyeongsang National University, Jinju, South Korea.'}, {'ForeName': 'Y-W', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': 'Centre for Gastric Cancer.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Yoon', 'Affiliation': 'Centre for Gastric Cancer.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Eom', 'Affiliation': 'Centre for Gastric Cancer.'}, {'ForeName': 'M-C', 'Initials': 'MC', 'LastName': 'Kook', 'Affiliation': 'Centre for Gastric Cancer.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Han', 'Affiliation': 'Biostatistics Collaboration Team, National Cancer Centre, Goyang, South Korea.'}, {'ForeName': 'B-H', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Clinical Design Research Centre, HERINGS Institute of Advanced Clinical and Biomedical Research, Seoul, South Korea.'}, {'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Ryu', 'Affiliation': 'Centre for Gastric Cancer.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of surgery,['10.1002/bjs.11655']
1862,31561325,The effect of different exercise types on sedentary young women's lipid profile.,"BACKGROUND
Individualized exercise programs should be prepared according to duration and intensity.
OBJECTIVE
The current study focused on the effect of different types of exercises regularly done for eight weeks on sedentary young women's body components and lipid profile.
METHODS
The sample of the study was composed of 30 sedentary women recruited from Afyon Kocatepe University. The participants were randomly sorted into three groups and received combined exercises (aerobic + resistance exercises), aerobic exercises and cardio tennis exercises three days a week for eight weeks but no dietary program was given. Before and after the exercise programs, participants' body weights, heights, waist and hip circumferences were measured and their body components were analyzed through the bioelectrical impedance method. For the lipid profile analyses, 5 cc. of blood samples were drawn from forearm veins of the participants with the help of health specialists, and a biochemical doctor analyzed lipid profile markers such as total cholesterol, triglyceride, HDL, LDL, and VLDL.
RESULTS
It was found that exercises regularly done for eight weeks affected young women's body components considerably while it did not influence their lipid profile.
CONCLUSIONS
The effect on body components depended on time. No difference was found in terms of exercise type.",2020,"It was found that exercises regularly done for eight weeks affected young women's body components considerably while it did not influence their lipid profile.
","['30 sedentary women recruited from Afyon Kocatepe University', ""sedentary young women's body components and lipid profile"", ""sedentary young women's lipid profile""]","['combined exercises (aerobic + resistance exercises), aerobic exercises and cardio tennis exercises three days a week for eight weeks but no dietary program']","['total cholesterol, triglyceride, HDL, LDL, and VLDL']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}]",30.0,0.0229038,"It was found that exercises regularly done for eight weeks affected young women's body components considerably while it did not influence their lipid profile.
","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Yildirim', 'Affiliation': 'School of Physical Education and Sports, Mersin University, Mersin, Turkey.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aydin Altinbas', 'Affiliation': 'School of Physical Education and Sports, Afyon Kocatepe University, Afyonkarahisar, Turkey.'}, {'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Demirezen', 'Affiliation': 'School of Physical Education and Sports, Afyon Kocatepe University, Afyonkarahisar, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dener', 'Affiliation': 'School of Physical Education and Sports, Afyon Kocatepe University, Afyonkarahisar, Turkey.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sezgin', 'Affiliation': 'School of Physical Education and Sports, Afyon Kocatepe University, Afyonkarahisar, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181323']
1863,26870676,Exploratory studies on the therapeutic effects of Kumarabharana Rasa in the management of chronic tonsillitis among children at a tertiary care hospital of Karnataka.,"The effect of an Ayurvedic poly-herbo-mineral formulation Kumarabharana Rasa (KR) in the management of chronic tonsillitis (Tundikeri) in children has been assessed in this study. This clinical study was a double-arm study with a pre- and post-test design at the outpatient level in a tertiary Ayurveda hospital attached to a teaching institute located in district headquarters in Southern India. Patients (n = 40) with chronic tonsillitis satisfying diagnostic criteria and aged between 5 and 10 years were selected from the outpatient Department of Kaumarbhritya, SDM College of Ayurveda and Hospital, Hassan. Among them, 20 patients were treated with Kumarabharana rasa (tablet form) at a dose of 500 mg once daily for 30 days (Group A). The other 20 patients were treated with Godhuma Vati (placebo) at a dose of 500 mg once daily for 30 days (Group B). In both groups, Madhu was the Anupana advised. After completion of 30 days of treatment, the patients were assessed on the following day and another investigation took place 15 days later. Statistically significant effects (p < 0.05) in the reduction of all signs and symptoms of chronic tonsillitis after KR treatment were observed. These results indicate that Kumarabharana Rasa has an ameliorative effect in reducing the signs and symptoms of chronic tonsillitis.",2016,Statistically significant effects (p < 0.05) in the reduction of all signs and symptoms of chronic tonsillitis after KR treatment were observed.,"['chronic tonsillitis among children at a tertiary care hospital of Karnataka', 'outpatient level in a tertiary Ayurveda hospital attached to a teaching institute located in district headquarters in Southern India', 'chronic tonsillitis (Tundikeri) in children', 'Patients (n\xa0', '20 patients were treated with', '40) with chronic tonsillitis satisfying diagnostic criteria and aged between 5 and 10 years were selected from the outpatient Department of Kaumarbhritya, SDM College of Ayurveda and Hospital, Hassan']","['Godhuma Vati (placebo', 'Ayurvedic poly-herbo-mineral formulation Kumarabharana Rasa (KR', 'Kumarabharana rasa', 'Kumarabharana Rasa']","['reduction of all signs and symptoms of chronic tonsillitis', 'signs and symptoms of chronic tonsillitis']","[{'cui': 'C0149517', 'cui_str': 'Chronic tonsillitis (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0025122', 'cui_str': 'Medicine, Ayurvedic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0149517', 'cui_str': 'Chronic tonsillitis (disorder)'}]",20.0,0.028425,Statistically significant effects (p < 0.05) in the reduction of all signs and symptoms of chronic tonsillitis after KR treatment were observed.,"[{'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Arun Raj', 'Affiliation': 'Department of Kaumarabhritya, SDM College of Ayurveda and Hospital, Hassan, Karnataka, India.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Shailaja', 'Affiliation': 'Department of Kaumarabhritya, SDM College of Ayurveda and Hospital, Hassan, Karnataka, India.'}, {'ForeName': 'Parikshit', 'Initials': 'P', 'LastName': 'Debnath', 'Affiliation': 'Department of Swasthavritta, SDM College of Ayurveda and Hospital, Hassan, Karnataka, India.'}, {'ForeName': 'Subhadip', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Pharmacology, Bengal Institute of Pharmaceutical Sciences, Kalyani, West Bengal, India.'}, {'ForeName': 'Prasanna N', 'Initials': 'PN', 'LastName': 'Rao', 'Affiliation': 'Department of Shalyatantra, SDM College of Ayurveda and Hospital, Hassan, Karnataka, India.'}]",Journal of traditional and complementary medicine,['10.1016/j.jtcme.2014.11.031']
1864,26543445,"Comments on ""combination of dexmedetomidine and remifentanil for labor analgesia: A double-blinded, randomized, controlled study"".",,2015,,['labor analgesia'],['dexmedetomidine and remifentanil'],[],"[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]",[],,0.640795,,"[{'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Ortiz-Gómez', 'Affiliation': 'Department of Anesthesiology, Navarra Hospital Complex, Pamplona, Spain.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159453']
1865,26543446,Hemodynamic response to endotracheal intubation using C-Trach assembly and direct laryngoscopy.,"PURPOSE
Our objective was to study the pressor response to endotracheal intubation through laryngeal mask airway C-Trach and compare it to the hemodynamic response to intubation with direct laryngoscopy (DL).
MATERIALS AND METHODS
After obtained approval from institutional ethical committee, 100 patients of American Society of Anesthesiologists physical Status I, aged 14-65 years, posted for elective surgery were enrolled in the trial. They were randomly divided into two groups of each 50 patients. Anesthesia technique was standardized and patients of Group I were intubated using DL, while patients of Group II were intubated with the help of C-Trach assembly. Hemodynamic parameters, systemic blood pressure (systolic and diastolic) and heart rate were recorded before and after induction of anesthesia and every minute up to 5 min after intubation.
RESULTS
Patients of Group II recorded a minimal rise in peak systolic blood pressure (SBP) (1.8%) and diastolic blood pressure (10.6%). In comparison patients of Group I recorded a significant sustained rise in peak SBP (20.3%) and diastolic blood pressure (21.4%). However heart rate changes recorded in the two groups were of equal measure (peak rise of 22.9% in Group I vs. 22.4% in Group II).
CONCLUSION
We conclude that intubation through C-Trach generates a lower pressor response to intubation in comparison to intubation using DL.",2015,"RESULTS
Patients of Group II recorded a minimal rise in peak systolic blood pressure (SBP) (1.8%) and diastolic blood pressure (10.6%).","['100 patients of American Society of Anesthesiologists physical Status I, aged 14-65 years, posted for elective surgery were enrolled in the trial']","['endotracheal intubation through laryngeal mask airway C-Trach', 'direct laryngoscopy (DL']","['Hemodynamic parameters, systemic blood pressure (systolic and diastolic) and heart rate', 'pressor response', 'peak SBP', 'heart rate changes', 'diastolic blood pressure', 'Hemodynamic response', 'peak systolic blood pressure (SBP']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0396623', 'cui_str': 'Tracheal intubation through a laryngeal mask airway (procedure)'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0212513,"RESULTS
Patients of Group II recorded a minimal rise in peak systolic blood pressure (SBP) (1.8%) and diastolic blood pressure (10.6%).","[{'ForeName': 'Jayita', 'Initials': 'J', 'LastName': 'Sarkar', 'Affiliation': 'Department of Anesthesiology, JLN Hospital and Research Center, Bhilai Steel Plant, Bhilai, Chhattisgarh, India.'}, {'ForeName': 'Tanuja', 'Initials': 'T', 'LastName': 'Anand', 'Affiliation': 'Department of Anesthesiology, JLN Hospital and Research Center, Bhilai Steel Plant, Bhilai, Chhattisgarh, India.'}, {'ForeName': 'Sunil Kant', 'Initials': 'SK', 'LastName': 'Kamra', 'Affiliation': 'Department of Anesthesiology, JLN Hospital and Research Center, Bhilai Steel Plant, Bhilai, Chhattisgarh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154702']
1866,26543447,Success rates and complications of awake caudal versus spinal block in preterm infants undergoing inguinal hernia repair: A prospective study.,"BACKGROUND
Inguinal hernia is a common disease in preterm infants necessitating surgical repair. Despite the increased risk of postoperative apnea in preterm infants, the procedure was conventionally performed under general anesthesia. Recently, regional anesthesia approaches, including spinal and caudal blocks have been proposed as safe and efficient alternative anesthesia methods in this group of patients. The current study evaluates awake caudal and spinal blocks in preterm infants undergoing inguinal hernia repair.
MATERIALS AND METHODS
In a randomized clinical trial, 66 neonates and infants (weight <5 kg) undergoing inguinal hernia repair were recruited in Tabriz Teaching Children Hospital during a 12-month period. They were randomly divided into two equal groups; receiving either caudal block by 1 ml/kg of 0.25% bupivacaine plus 20 μg adrenaline (group C) or spinal block by 1 mg/kg of 0.5% bupivacaine plus 20 μg adrenaline (group S). Vital signs and pain scores were documented during operation and thereafter up to 24 h after operation.
RESULTS
Decrease in heart rate and systolic blood pressure was significantly higher in group C throughout the study period (P < 0.05). The mean recovery time was significantly higher in group S (27.3 ± 5.5 min vs. 21.8 ± 9.3 min; P = 0.03). Postoperative need for analgesia was significantly more frequent in group S (75.8% vs. 36.4%; P = 0.001). Failure in anesthesia was significantly higher in group S (24.4% vs. 6.1%; P = 0.04).
CONCLUSION
More appropriate success rate, duration of recovery and postoperative need of analgesics could contribute to caudal block being a superior anesthesia technique compared to spinal anesthesia in awaked preterm infants undergoing inguinal hernia repair.",2015,Postoperative need for analgesia was significantly more frequent in group S (75.8% vs. 36.4%; P = 0.001).,"['preterm infants', '66 neonates and infants (weight <5 kg) undergoing inguinal hernia repair were recruited in Tabriz Teaching Children Hospital during a 12-month period', 'preterm infants necessitating surgical repair', 'preterm infants undergoing inguinal hernia repair', 'awaked preterm infants undergoing inguinal hernia repair']","['awake caudal versus spinal block', 'spinal anesthesia', 'caudal block by 1 ml/kg of 0.25% bupivacaine plus 20 μg adrenaline (group C) or spinal block by 1 mg/kg of 0.5% bupivacaine plus 20 μg adrenaline']","['Postoperative need for analgesia', 'mean recovery time', 'Failure in anesthesia', 'heart rate and systolic blood pressure', 'risk of postoperative apnea', 'Vital signs and pain scores']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0518766'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",66.0,0.153734,Postoperative need for analgesia was significantly more frequent in group S (75.8% vs. 36.4%; P = 0.001).,"[{'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Seyedhejazi', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Abdolnaser', 'Initials': 'A', 'LastName': 'Moghadam', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behzad Aliakbari', 'Initials': 'BA', 'LastName': 'Sharabiani', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samad E J', 'Initials': 'SE', 'LastName': 'Golzari', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Taghizadieh', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154704']
1867,26543466,A prospective study to evaluate and compare laryngeal mask airway ProSeal and i-gel airway in the prone position.,"BACKGROUND
Prone position is commonly used to provide surgical access to a variety of surgeries. In view of the advantages of induction of anesthesia in the prone position, we conducted a randomized study to evaluate and compare ProSeal laryngeal mask airway (LMA) and i-gel in the prone position.
MATERIALS AND METHODS
Totally, 40 patients of either sex as per American Society of Anesthesiologists physical status I or II, between 16 and 60 years of age, scheduled to undergo surgery in prone position were included in the study. After the patients positioned themselves prone on the operating table, anesthesia was induced by the standard technique. LMA ProSeal was used as an airway conduit in group 1 while i-gel was used in group 2. At the end of surgery, the airway device was removed in the same position.
RESULTS
Insertion of airway device was successful in first attempt in 16, and 17 cases in ProSeal laryngeal mask airway (PLMA) and i-gel groups, respectively. A second attempt was required to secure the airway in 4 and 3 patients in PLMA and i-gel groups, respectively. The mean insertion time was 21.8 ± 2.70 s for group 1 and 13.1 ± 2.24 s for group 2, the difference being statistically significant (P < 0.05). The mean seal pressure in group 1 was 36 ± 6.22 cm H2 O and in group 2 was 25.4 ± 3.21 cm H2 O. The difference was statistically significant (P < 0.05). 13 patients in group 1 had fiberoptic bronchoscopy (FOB) grade 1 while it was 6 for group 2. The remaining patients in both groups had FOB grade 2.
CONCLUSION
Insertion of supraglottic airways and conduct of anesthesia with them is feasible in the prone position. The PLMA has a better seal while insertion is easier with i-gel.",2015,13 patients in group 1 had fiberoptic bronchoscopy (FOB) grade 1 while it was 6 for group 2.,"['I or II, between 16 and 60 years of age, scheduled to undergo surgery in prone position were included in the study', 'Totally, 40 patients of either sex as per American Society of Anesthesiologists physical status', '13 patients in group 1 had fiberoptic bronchoscopy (FOB) grade 1 while it was 6 for group 2']","['ProSeal laryngeal mask airway (LMA) and i-gel', 'laryngeal mask airway ProSeal and i-gel airway', 'PLMA']","['mean seal pressure', 'FOB grade 2', 'mean insertion time']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0033422', 'cui_str': 'Prone Position'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0189391', 'cui_str': 'Fiberoptic bronchoscopy (procedure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0444858', 'cui_str': 'AM 6 (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0298132,13 patients in group 1 had fiberoptic bronchoscopy (FOB) grade 1 while it was 6 for group 2.,"[{'ForeName': 'Susheela', 'Initials': 'S', 'LastName': 'Taxak', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pt. B. D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Ajith', 'Initials': 'A', 'LastName': 'Gopinath', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pt. B. D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Saini', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pt. B. D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Teena', 'Initials': 'T', 'LastName': 'Bansal', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pt. B. D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Mangal Singh', 'Initials': 'MS', 'LastName': 'Ahlawat', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pt. B. D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Bala', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pt. B. D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159473']
1868,32413933,Adalimumab for maintenance of remission in Crohn's disease.,"BACKGROUND
Conventional medications for Crohn's disease (CD) include anti-inflammatory drugs, immunosuppressants and corticosteroids. If an individual does not respond, or loses response to first-line treatments, then biologic therapies such as tumour necrosis factor-alpha (TNF-α) antagonists such as adalimumab are considered for treating CD. Maintenance of remission of CD is a clinically important goal, as disease relapse can negatively affect quality of life.
OBJECTIVES
To assess the efficacy and safety of adalimumab for maintenance of remission in people with quiescent CD.
SEARCH METHODS
We searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, Embase, and clinicaltrials.gov from inception to April 2019.
SELECTION CRITERIA
We considered for inclusion randomized controlled trials (RCTs) comparing adalimumab to placebo or to an active comparator.
DATA COLLECTION AND ANALYSIS
We analyzed data on an intention-to-treat basis. We calculated risk ratios (RRs) and corresponding 95% confidence intervals (95% CI) for dichotomous outcomes. The primary outcome was failure to maintain clinical remission. We define clinical remission as a Crohn's Disease Activity Index (CDAI) score of < 150. Secondary outcomes were failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs). We assessed biases using the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of evidence supporting the primary outcome.
MAIN RESULTS
We included six RCTs (1158 participants). We rated four trials at low risk of bias and two trials at unclear risk of bias. All participants had moderate-to-severe CD that was in clinical remission. Four studies were placebo-controlled (1012 participants). Two studies (70 participants) compared adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine) in participants who had an ileocolic resection prior to study enrolment. Adalimumab versus placebo Fifty-nine per cent (252/430) of participants treated with adalimumab failed to maintain clinical remission at 52 to 56 weeks, compared with 86% (217/253) of participants receiving placebo (RR 0.70, 95% CI 0.64 to 0.77; 3 studies, 683 participants; high-certainty evidence). Among those who received prior TNF-α antagonist therapy, 69% (129/186) of adalimumab participants failed to maintain clinical or endoscopic response at 52 to 56 weeks, compared with 93% (108/116) of participants who received placebo (RR 0.76, 95% CI 0.68 to 0.85; 2 studies, 302 participants; moderate-certainty evidence). Fifty-one per cent (192/374) of participants who received adalimumab failed to maintain clinical remission at 24 to 26 weeks, compared with 79% (149/188) of those who received placebo (RR 0.66, 95% CI 0.52 to 0.83; 2 studies, 554 participants; moderate-certainty evidence). Eighty-seven per cent (561/643) of participants who received adalimumab reported an AE compared with 85% (315/369) of participants who received placebo (RR 1.01, 95% CI 0.94 to 1.09; 4 studies, 1012 participants; high-certainty evidence). Serious adverse events were seen in 8% (52/643) of participants who received adalimumab and 14% (53/369) of participants who received placebo (RR 0.56, 95% CI 0.39 to 0.80; 4 studies, 1012 participants; moderate-certainty evidence) and withdrawal due to AEs was reported in 7% (45/643) of adalimumab participants compared to 13% (48/369) of placebo participants (RR 0.59, 95% CI 0.38 to 0.91; 4 studies, 1012 participants; moderate-certainty evidence). Commonly-reported AEs included CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain. Adalimumab versus active comparators No studies reported failure to maintain clinical remission. One study reported on failure to maintain clinical response and endoscopic remission at 104 weeks in ileocolic resection participants who received either adalimumab, azathioprine or mesalamine as post-surgical maintenance therapy. Thirteen per cent (2/16) of adalimumab participants failed to maintain clinical response compared with 54% (19/35) of azathioprine or mesalamine participants (RR 0.23, 95% CI 0.06 to 0.87; 51 participants). Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence). One study reported on failure to maintain endoscopic response at 24 weeks in ileocolic resection participants who received either adalimumab or 6-mercaptopurine (6-MP) as post-surgical maintenance therapy. Nine per cent (1/11) of adalimumab participants failed to maintain endoscopic remission compared with 50% (4/8) of 6-MP participants (RR 0.18, 95% CI 0.02 to 1.33; 19 participants).
AUTHORS' CONCLUSIONS
Adalimumab is an effective therapy for maintenance of clinical remission in people with quiescent CD. Adalimumab is also effective in those who have previously been treated with TNF-α antagonists. The effect of adalimumab in the post-surgical setting is uncertain. More research is needed in people with recent bowel surgery for CD to better determine treatment plans following surgery. Future research should continue to explore factors that influence initial and subsequent biologic selection for people with moderate-to-severe CD. Studies comparing adalimumab to other active medications are needed, to help determine the optimal maintenance therapy for CD.",2020,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","['people with moderate-to-severe CD', ""Crohn's disease"", 'people with quiescent CD', 'participants who had an ileocolic resection prior to study enrolment']","['adalimumab to placebo', 'azathioprine', 'adalimumab', '6-MP', 'adalimumab or 6-mercaptopurine (6-MP', 'TNF-α antagonist therapy', 'adalimumab, azathioprine or mesalamine', 'azathioprine or mesalamine', 'mesalamine', 'Adalimumab', 'Adalimumab versus active comparators', 'adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine', 'placebo']","['maintain clinical response', 'maintain clinical or endoscopic response', 'maintain endoscopic remission', ""Crohn's Disease Activity Index (CDAI) score"", 'efficacy and safety', 'maintain clinical remission', 'moderate-certainty evidence) and withdrawal due to AEs', 'failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs', 'CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain', 'failure to maintain clinical remission', 'calculated risk ratios (RRs', 'Serious adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C1280902', 'cui_str': 'Ileocolic resection'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",,0.562927,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","[{'ForeName': 'Cassandra M', 'Initials': 'CM', 'LastName': 'Townsend', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cepek', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Abbass', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012877.pub2']
1869,31563255,A Cost Analysis and Cost-Utility Analysis of a Community Pharmacist-Led Intervention on Reducing Cardiovascular Risk: The Alberta Vascular Risk Reduction Community Pharmacy Project (R x EACH).,"BACKGROUND
A randomized trial (the Alberta Vascular Risk Reduction Community Pharmacy Project) showed that a community pharmacist-led intervention was efficacious for reducing cardiovascular (CV) risk. However, the cost of this strategy is unknown.
OBJECTIVES
We examined the short- and long-term cost of a pharmacist-led intervention to reduce CV risk compared to usual care.
METHODS
We conducted a trial-based cost analysis from the perspective of a publicly funded healthcare system. Over 3 and 12 months of follow-up, we examined specific intervention costs (pharmacy claims), related intervention costs (laboratory tests and medications), and ongoing healthcare costs (physician claims, emergency department visits, and hospital admissions). We also used the validated CV Disease Policy Model-Canada to estimate the long-term effects.
RESULTS
A total of 684 participants (mean age 62, 57% male) were included. Overall, there were no significant differences in healthcare costs at 3 or 12 months between the usual care and intervention groups (P = .127). The CV disease-related healthcare cost of managing a patient over a lifetime was estimated to be Can$45 530 (95% uncertainty interval [UI], 45 460-45 580) and Can$40 750 (95% UI, 37 780-43 620) in usual care and intervention groups, respectively, an incremental cost savings of Can$4770 per patient (95% UI, 1900-7760). The intervention dominated usual care (better outcomes and lower costs) across 3-year, 5-year, 10-year, and lifetime horizons.
CONCLUSION
This economic analysis suggests that a clinical pathway-driven pharmacist-led intervention (previously shown to reduce CV risk) was associated with similar measured healthcare costs over 1 year, and lower extrapolated healthcare costs over a patient lifetime. This strategy could be broadly implemented to realize its benefits.",2019,"Overall, there were no significant differences in healthcare costs at 3 or 12 months between the usual care and intervention groups (P = .127).","['684 participants (mean age 62, 57% male) were included']","['pharmacist-led intervention', 'Community Pharmacist-Led Intervention']","['healthcare costs', 'CV risk', 'cardiovascular (CV) risk', 'CV disease-related healthcare cost of managing a patient over a lifetime', 'Cardiovascular Risk', 'specific intervention costs (pharmacy claims), related intervention costs (laboratory tests and medications), and ongoing healthcare costs (physician claims, emergency department visits, and hospital admissions']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0402003', 'cui_str': 'Community Pharmacists'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",684.0,0.0863447,"Overall, there were no significant differences in healthcare costs at 3 or 12 months between the usual care and intervention groups (P = .127).","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tam-Tham', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Clement', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Brenda R', 'Initials': 'BR', 'LastName': 'Hemmelgarn', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. Electronic address: brenda.hemmelgarn@ahs.ca.'}, {'ForeName': 'Braden J', 'Initials': 'BJ', 'LastName': 'Manns', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Klarenbach', 'Affiliation': 'EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tonelli', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Ross T', 'Initials': 'RT', 'LastName': 'Tsuyuki', 'Affiliation': 'EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; Department of Pharmacology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Yazid N', 'Initials': 'YN', 'LastName': 'Al Hamarneh', 'Affiliation': 'EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Penko', 'Affiliation': 'Centre for Vulnerable Populations, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Colin G W', 'Initials': 'CGW', 'LastName': 'Weaver', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Au', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Weaver', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Jones', 'Affiliation': 'Department of Medicine, Southern Medical Program, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'McBrien', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Family Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.05.012']
1870,32416073,"Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study.","BACKGROUND
Patients with advanced or metastatic oesophageal squamous cell carcinoma have poor prognosis and few treatment options after first-line therapy. We aimed to assess efficacy and safety of the anti-PD-1 antibody camrelizumab versus investigator's choice of chemotherapy in previously treated patients.
METHODS
ESCORT is a randomised, open-label, phase 3 study of patients aged 18 to 75 years with a histological or cytological diagnosis of advanced or metastatic oesophageal squamous cell carcinoma done at 43 hospitals in China. Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and had progressed on, or were intolerant to, first-line standard therapy. Patients were randomly assigned (1:1) to camrelizumab (200 mg every 2 weeks) or chemotherapy with docetaxel (75 mg/m 2 every 3 weeks) or irinotecan (180 mg/m 2 every 2 weeks), all given intravenously. Central randomisation was done using the Randomization and Trial Supply Management system with block size randomly generated as four or six and stratified by disease and ECOG performance status. The primary endpoint was overall survival, assessed in randomised patients who had received at least one dose of treatment. Safety was assessed in all treated patients. The trial is registered with ClinicalTrials.gov, NCT03099382, and is closed to new participants.
FINDINGS
From May 10, 2017, to July 24, 2018, 457 (75%) of 607 screened patients were randomly assigned to treatment, of whom 228 received camrelizumab treatment and 220 received chemotherapy. As of data cutoff on May 6, 2019, with a median follow-up time of 8·3 months (IQR 4·1-12·8) in the camrelizumab group and 6·2 months (3·6-10·1) in the chemotherapy group, median overall survival was 8·3 months (95% CI 6·8-9·7) in the camrelizumab group and 6·2 months (5·7-6·9) in the chemotherapy group (hazard ratio 0·71 [95% CI 0·57-0·87]; two-sided p=0·0010). The most common treatment-related adverse events of grade 3 or worse were anaemia (camrelizumab vs chemotherapy: six [3%] vs 11 [5%]), abnormal hepatic function (four [2%] vs one [<1%]), and diarrhoea (three [1%] vs nine [4%]). Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group. Ten treatment-related deaths occurred, seven (3%) in the camrelizumab group (three deaths from unknown causes, one enterocolitis, one hepatic function abnormal, one pneumonitis, and one myocarditis) and three (1%) in the chemotherapy group (two deaths from unknown causes, and one gastrointestinal haemorrhage).
INTERPRETATION
Second-line camrelizumab significantly improved overall survival in patients with advanced or metastatic oesophageal squamous cell carcinoma compared with chemotherapy, with a manageable safety profile. It might represent a potential option of standard second-line treatment for patients with oesophageal squamous cell carcinoma in China.
FUNDING
Jiangsu Hengrui Medicine.",2020,"Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group.","['Patients with advanced or metastatic oesophageal squamous cell carcinoma', 'Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and had progressed on, or were intolerant to, first-line standard therapy', 'From May 10, 2017, to July 24, 2018, 457 (75%) of 607 screened patients', 'advanced or metastatic oesophageal squamous cell carcinoma (ESCORT', 'patients with oesophageal squamous cell carcinoma in China', 'patients with advanced or metastatic oesophageal squamous cell carcinoma', 'patients aged 18 to 75 years with a histological or cytological diagnosis of advanced or metastatic oesophageal squamous cell carcinoma done at 43 hospitals in China', 'previously treated patients']","['anti-PD-1 antibody camrelizumab', 'camrelizumab', 'chemotherapy with docetaxel', 'Camrelizumab', 'camrelizumab treatment and 220 received chemotherapy', 'chemotherapy', 'irinotecan']","['Safety', 'overall survival', 'diarrhoea', 'efficacy and safety', 'median overall survival', 'adverse events', 'deaths', 'abnormal hepatic function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}]",,0.242005,"Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, Cancer Center, Fifth Medical Center General Hospital of PLA, Beijing, China. Electronic address: jmxu2003@yahoo.com.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'Department of Thoracic Medical Oncology, Fujian Province Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Oncology Department, The Second Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Helong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Oncology Department, Tangdu Hospital of the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zuoxing', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Internal Medicine Ward 4, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lizhu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Oncology Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Kangsheng', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': 'Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Medical Oncology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ba', 'Affiliation': 'Medical Oncology, Tianjin Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Oncology Department, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Oncology Department, The First People's Hospital of Lianyungang, Lianyungang, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': ""Oncology Center, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Radiotherapy, 900 Hospital of the Joint Logistics Team, Fuzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'The Oncology Department, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiotherapy, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xianbao', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Department of Medical Oncology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Integrated Chinese and Western Medical Oncology, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Medical Oncology, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30110-8']
1871,32492727,Influence of Clinical Expertise Between Clinician-Instructors Versus Student-Instructors on the Effectiveness of Ultrasound Courses.,"PURPOSE
To investigate how the extent of an ultrasound instructor's clinical expertise influences the level of hands-on ultrasound competency achieved by clinicians after three-day ultrasound courses in abdominal and emergency ultrasound. The second goal was to determine how physicians in residency rate the sonographic and didactic skills of student instructors compared to medical staff instructors.
METHOD
A total of N = 100 residents participating in a 3-day ultrasound workshop were randomly trained either by 15 student instructors or by clinical staff physicians, both with > 2 years of teaching experience. Both instructor groups had previously completed 120 hours of didactic instructor training. Ultrasound competencies were assessed by a standardized objective structured clinical examination (OSCE) of healthy individuals. The sonographic and didactic skills of both instructor groups were rated by questionnaires with six-step Likert items (1 = excellent, 6 = poor).
RESULTS
The cohort, trained by student instructors, achieved the same scoring level as the second cohort, trained by physician instructors (mean score 76.4, versus 73.7 of max. 100 points, p = 0.28) in the final OSCE. The sonographic qualification was rated for student educators as 1.44 (mean) [1.1-1.62], versus residents 1.46 [1.26-1.61], versus attendings 1.29 [1.05-1.61]. Didactic skill levels were rated without significant differences with means of 1.53, 1.57 and 1.53, respectively.
DISCUSSION & CONCLUSION
The didactic competence of student instructors does not differ statistically from the competency levels of experienced physicians. In terms of the acquired ultrasound skills of trainees, our data indicate that student instructors can be as efficient as staff instructors. Therefore, student instructors can be employed as resource-saving ultrasound educators without decreasing the skills level achieved by course participants, provided that they previously underwent a comprehensive didactic and sonographic training program.",2020,"Didactic skill levels were rated without significant differences with means of 1.53, 1.57 and 1.53, respectively.
","['A total of N\u200a=\u200a100 residents participating in a 3-day ultrasound workshop were randomly trained either by 15 student instructors or by clinical staff physicians, both with >\u200a2\xa0years of teaching experience']",['didactic instructor training'],"['sonographic qualification', 'Didactic skill levels', 'sonographic and didactic skills']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0230268,"Didactic skill levels were rated without significant differences with means of 1.53, 1.57 and 1.53, respectively.
","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hofer', 'Affiliation': 'Department of Radiology, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kamper', 'Affiliation': 'Diagnostic and Interventional Radiology, Witten-Herdecke-University, Wuppertal, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Heussen', 'Affiliation': 'Institute for medical statistics, University Clinic UKA, Aachen, Germany.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Martin', 'Affiliation': 'Diagnostic and Interventional Radiology, Heinrich-Heine-Universität Düsseldorf, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Heverhagen', 'Affiliation': 'Department of Radiology, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}]","Ultraschall in der Medizin (Stuttgart, Germany : 1980)",['10.1055/a-1176-0622']
1872,31561326,Feasibility of supplemental robot-assisted knee flexion exercise following total knee arthroplasty.,"BACKGROUND
The Hybrid Assistive Limb (HAL) is a robotic exoskeleton designed to support impaired limbs.
OBJECTIVE
We aimed to evaluate whether active exercise using a single-joint HAL (HAL-SJ) following total knee arthroplasty can facilitate the recovery of knee flexion.
METHODS
Twenty-two patients who underwent total knee arthroplasty were randomly allocated to the HAL-SJ group (n= 12) or conventional physical therapy (CPT) group (n= 10). On postoperative day 5, patients performed active knee flexion exercises either with or without HAL-SJ assistance every second day. Outcome measures included active and passive knee flexion range of motion (ROM), muscle strength, and pain intensity, as assessed by the visual analog scale, and were assessed on postoperative days 5 (pre-treatment) and 10 (post-treatment). Active ROM was measured at 6 months postoperatively; further long-term follow-up was performed by telephone interview.
RESULTS
Both groups showed significant improvement between postoperative days 5 and 10 in all outcome measures. Improvements in active ROM (p< 0.01), passive ROM (p< 0.01), muscle strength (p< 0.01), and pain (p< 0.01) were significantly greater in the HAL-SJ group than in the CPT group. Long-term outcomes were also significantly better in the HAL-SJ group.
CONCLUSIONS
HAL therapy enables patients to perform painless active movements and facilitates the recovery of knee function.",2020,"Improvements in active ROM (p< 0.01), passive ROM (p< 0.01), muscle strength (p< 0.01), and pain (p< 0.01) were significantly greater in the HAL-SJ group than in the CPT group.","['total knee arthroplasty', 'Twenty-two patients who underwent total knee arthroplasty']","['HAL-SJ', 'Hybrid Assistive Limb (HAL', 'active knee flexion exercises either with or without HAL-SJ assistance', 'supplemental robot-assisted knee flexion exercise', 'HAL therapy', 'conventional physical therapy (CPT', 'active exercise using a single-joint HAL (HAL-SJ', 'CPT']","['Active ROM', 'passive ROM', 'pain', 'active and passive knee flexion range of motion (ROM), muscle strength, and pain intensity, as assessed by the visual analog scale', 'muscle strength', 'active ROM']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0419117', 'cui_str': 'Active exercise (regime/therapy)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",22.0,0.0458674,"Improvements in active ROM (p< 0.01), passive ROM (p< 0.01), muscle strength (p< 0.01), and pain (p< 0.01) were significantly greater in the HAL-SJ group than in the CPT group.","[{'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Kotani', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Morishita', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Saita', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kamada', 'Affiliation': 'Department of Rehabilitation Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Maeyama', 'Affiliation': 'Department of Orthopedic Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Abe', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Takuaki', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Orthopedic Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Etsuji', 'Initials': 'E', 'LastName': 'Shiota', 'Affiliation': 'Department of Rehabilitation Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Tooru', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181482']
1873,32416385,Transdiagnostic preventative intervention for subclinical anxiety: Development and initial validation.,"Risk factors associated with the development of anxiety disorders have been identified; however, the development of preventive interventions targeting these risk factors is in the nascent stage. To date, preventive interventions have tended to target specific anxiety disorder symptoms (e.g., panic attacks). Although these interventions are effective at reducing risk for the targeted disorder (e.g., panic disorder), the focus of the intervention is narrow, thereby limiting the dissemination of these interventions. One approach that may broaden the scope of our prevention efforts is the development of a transdiagnostic intervention. Currently, transdiagnostic interventions have only been used in those with diagnosed conditions (e.g., anxiety disorders); however, it stands to reason that a transdiagnostic approach may also be helpful for those at-risk for developing anxiety disorders. The present study reported on the development and use of a brief preventative intervention for those with subclinical anxiety (i.e., worry, social anxiety). Participants were randomized into either a transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group. Participants consisted of sixty-nine individuals with subclinical levels of anxiety. Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group. Further, change in safety aid utilization was a significant mediator in the association between intervention group and social anxiety and worry at Week 1; however, it was not a significant mediator at Month 1. Implications of these results and avenues for future research are discussed.",2020,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.",['Participants consisted of sixty-nine individuals with subclinical levels of anxiety'],"['transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group', 'Transdiagnostic preventative intervention']","['safety aid utilization', 'social anxiety, worry, and levels of impairment', 'social anxiety and worry']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",69.0,0.0158088,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.","[{'ForeName': 'Kristina J', 'Initials': 'KJ', 'LastName': 'Korte', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA; Harvard T.H. Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: kkorte@mgh.harvard.edu.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, Tallahassee, FL, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.001']
1874,31545681,"Effect of Transdermal Testosterone and Oral Progesterone on Drug-Induced QT Interval Lengthening in Older Men: A Randomized, Double-Blind, Placebo-Controlled Crossover-Design Study.",,2019,,['Older Men'],"['Placebo', 'Transdermal Testosterone and Oral Progesterone']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],,0.332368,,"[{'ForeName': 'Elena Tomaselli', 'Initials': 'ET', 'LastName': 'Muensterman', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jaynes', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Sowinski', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Overholser', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (C.S.).'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Kovacs', 'Affiliation': 'Krannert Institute of Cardiology (R.J.K.), School of Medicine, Indiana University, Indianapolis.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Tisdale', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041395']
1875,31554422,Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography-Guided Revascularization in Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease: The CROSS-AMI Randomized Clinical Trial.,"BACKGROUND
Recent trials suggest that complete revascularization in patients with acute ST-segment-elevation myocardial infarction and multivessel disease is associated with better outcomes than infarct-related artery (IRA)-only revascularization. There are different methods to select non-IRA lesions for revascularization procedures. We assessed the clinical outcomes of complete angiographically guided revascularization versus stress echocardiography-guided revascularization in patients with ST-segment-elevation myocardial infarction.
METHODS
We performed a randomized clinical trial in patients with multivessel disease who underwent a successful percutaneous coronary intervention of the IRA to test differences in prognosis (composite end point included cardiovascular mortality, nonfatal reinfarction, coronary revascularization, and readmission for heart failure after 12 months of follow-up) between complete angiographically guided revascularization (n=154) or stress echocardiography-guided revascularization (n=152) of the non-IRA lesions in an elective procedure before hospital discharge.
RESULTS
The trial was prematurely stopped after the inclusion of 77% of the planned study population. As many as 152 (99%) patients in the complete revascularization group and 44 (29%) patients in the selective revascularization group required a percutaneous coronary intervention procedure of a non-IRA lesion before discharge. The primary end point occurred in 21 (14%) patients of the stress echocardiography-guided revascularization group and 22 (14%) patients of the complete angiographically guided revascularization group (hazard ratio, 0.95; 95% CI, 0.52-1.72; P =0.85).
CONCLUSIONS
In patients with ST-segment-elevation myocardial infarction and multivessel disease, stress echocardiography-guided revascularization may not be significantly different to complete angiographically guided revascularization, thereby reducing the need for elective revascularization before hospital discharge.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01179126.",2019,"The primary end point occurred in 21 (14%) patients of the stress echocardiography-guided revascularization group and 22 (14%) patients of the complete angiographically guided revascularization group (hazard ratio, 0.95; 95% CI, 0.52-1.72; P =0.85).
","['Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease', 'patients with acute ST-segment-elevation myocardial infarction and multivessel disease', 'patients with multivessel disease who underwent a successful percutaneous coronary intervention of the IRA to test differences in prognosis (composite end point included cardiovascular mortality, nonfatal reinfarction, coronary revascularization, and readmission for heart failure after 12 months of follow-up) between complete angiographically guided revascularization (n=154) or', 'patients with ST-segment-elevation myocardial infarction and multivessel disease', 'n=152) of the non-IRA lesions in an elective procedure before hospital discharge', 'patients with ST-segment-elevation myocardial infarction']","['Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography-Guided Revascularization', 'stress echocardiography-guided revascularization', 'complete angiographically guided revascularization versus stress echocardiography-guided revascularization']",['percutaneous coronary intervention procedure of a non-IRA lesion'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0747973', 'cui_str': 'Elective procedure'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0920208', 'cui_str': 'Echocardiography, Stress'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",,0.0880571,"The primary end point occurred in 21 (14%) patients of the stress echocardiography-guided revascularization group and 22 (14%) patients of the complete angiographically guided revascularization group (hazard ratio, 0.95; 95% CI, 0.52-1.72; P =0.85).
","[{'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Calviño-Santos', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Estévez-Loureiro', 'Affiliation': 'Department of Cardiology, Hospital Alvaro Cunqueiro, Vigo, Spain (R.E.-L.).'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Peteiro-Vázquez', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Salgado-Fernández', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Rodríguez-Vilela', 'Affiliation': 'Department of Cardiology, Hospital Universitario Arquitecto Marcide, Ferrol, Spain (A.R.-V., A.M.-P.).'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Franco-Gutiérrez', 'Affiliation': 'Department of Cardiology, Hospital Universitario Lucus Augusti, Lugo, Spain (R.F.-G., C.G.-J.).'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bouzas-Mosquera', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'José Ángel', 'Initials': 'JÁ', 'LastName': 'Rodríguez-Fernández', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Mesías-Prego', 'Affiliation': 'Department of Cardiology, Hospital Universitario Arquitecto Marcide, Ferrol, Spain (A.R.-V., A.M.-P.).'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'González-Juanatey', 'Affiliation': 'Department of Cardiology, Hospital Universitario Lucus Augusti, Lugo, Spain (R.F.-G., C.G.-J.).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Aldama-López', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Piñón-Esteban', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Xacobe', 'Initials': 'X', 'LastName': 'Flores-Ríos', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Soler-Martín', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Seoane-Pillado', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Vázquez-González', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Muñiz', 'Affiliation': 'CIBERCV (Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares), Instituto de Salud Carlos III, Madrid, Spain (J.P.-V., J.S.-F., A.B.-M., N.V.-G., J.M., J.M.V.-R.).'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Vázquez-Rodríguez', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, INIBIC, Spain (R.C.-S., J.P.-V., J.S.-F., A.B.-M., J.A.R.-F., G.A.-L., P.P.-E., X.F.-R., R.S.-M., T.S.-P., N.V.-G., J.M.V.-R.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.007924']
1876,31554765,Effect of Statin on Stroke Recurrence Prevention at Different Infarction Locations: A Post Hoc Analysis of The J-STARS Study.,"AIM
Posterior circulation stroke (PCS) has different clinical features and prognosis compared with anterior circulation stroke (ACS), and whether the effect of statin therapy on stroke prevention differs according to infarction location remains unclear. This post hoc analysis of the J-STARS study aimed to compare the usefulness of statin at different infarction locations (i.e., ACS and PCS).
METHODS
In the J-STARS study, 1578 patients were randomly assigned to the pravastatin or control group. The subjects were divided into two subgroups (ACS and PCS groups) based on the arteries responsible for the infarction. Cox proportional hazards models were used to investigate whether the all stroke recurrence rate was different between the ACS and PCS groups.
RESULTS
The PCS group (n=499) had a significantly higher prevalence of diabetes than the ACS group (n=1022) (30.7% vs. 19.8%, P<0.001). During the follow-up (4.9±1.4 years), the incidence of all stroke was significantly lower in the pravastatin group than in the control group among patients with PCS (adjusted hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.25-0.83, P=0.009); however, the stroke recurrence rates were not significantly different between both groups among patients with ACS (adjusted HR 1.32, 95% CI 0.93-1.88,P=0.123). A significant interaction between the ACS and PCS groups in terms of pravastatin effects was noted (P=0.003 for interaction).
CONCLUSIONS
Pravastatin significantly reduced the recurrence rate of all stroke among patients with PCS. Thus, the effect of statin on the recurrence of stroke may differ according to infarction location.",2020,"During the follow-up (4.9±1.4 years), the incidence of all stroke was significantly lower in the pravastatin group than in the control group among patients with PCS (adjusted hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.25-0.83, P=0.009); however, the stroke recurrence rates were not significantly different between both groups among patients with ACS (adjusted HR 1.32, 95% CI 0.93-1.88,P=0.123).","['at Different Infarction Locations', '1578 patients', 'patients with PCS']","['Statin', 'pravastatin', 'Pravastatin', 'statin therapy', 'PCS', 'Posterior circulation stroke (PCS', 'ACS', 'statin']","['Stroke Recurrence Prevention', 'stroke recurrence rate', 'incidence of all stroke', 'prevalence of diabetes', 'stroke recurrence rates', 'recurrence rate', 'pravastatin effects']","[{'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",1578.0,0.0441505,"During the follow-up (4.9±1.4 years), the incidence of all stroke was significantly lower in the pravastatin group than in the control group among patients with PCS (adjusted hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.25-0.83, P=0.009); however, the stroke recurrence rates were not significantly different between both groups among patients with ACS (adjusted HR 1.32, 95% CI 0.93-1.88,P=0.123).","[{'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Nezu', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Hosomi', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine.""}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Center for Clinical Research, Kobe University Hospital.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Division of Medical Statistics, Translational Research Informatics Center, Foundation for Biomedical Research and Innovation.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Kagimura', 'Affiliation': 'Division of Medical Statistics, Translational Research Informatics Center, Foundation for Biomedical Research and Innovation.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Origasa', 'Affiliation': 'Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'National Cerebral and Cardiovascular Center.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'Clinical Research Center for Medicine, International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.51391']
1877,31434809,Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients With Acute Coronary Syndrome - The ODYSSEY J-IVUS Trial.,"BACKGROUND
In patients with acute coronary syndrome (ACS), alirocumab reduced the risk of recurring ischemic events. ODYSSEY J-IVUS assessed the effect of alirocumab on coronary atheroma volume in Japanese patients recently hospitalized with ACS and hypercholesterolemia, using intravascular ultrasound imaging analysis.Methods and Results:Patients (n=206) who at index ACS diagnosis either had low-density lipoprotein cholesterol (LDL-C) ≥2.59 mmol/L (≥100 mg/dL) despite stable statin therapy, or were not on statins with LDL-C levels above target after statin initiation, were randomized (1:1) to alirocumab (75 mg every 2 weeks [Q2 W]/up to 150 mg Q2 W), or standard of care (SoC; atorvastatin ≥10 mg/day or rosuvastatin ≥5 mg/day) for 36 weeks. The primary efficacy endpoint (week [W] 36 mean [standard error] percent change in normalized total atheroma volume [TAV] from baseline) was -3.1 (1.0)% with SoC vs. -4.8 (1.0)% with alirocumab (between-group difference: -1.6 [1.4]; P=0.23). W36 absolute change from baseline in percent atheroma volume was -1.3 (0.4)% (SoC) and -1.4 (0.4)% (alirocumab; nominal P=0.79). At W36, LDL-C was reduced from baseline by 13.4% (SoC) vs. 63.9% (alirocumab; nominal P<0.0001). In total, 61.8% (SoC) and 75.7% (alirocumab) of patients reported treatment-emergency adverse events.
CONCLUSIONS
In Japanese patients with ACS and hypercholesterolemia inadequately controlled despite statin therapy, from baseline to W36, a numerically greater percent reduction in normalized TAV was observed with alirocumab vs. SoC, which did not reach statistical significance.",2019,W36 absolute change from baseline in percent atheroma volume was -1.3,"['patients with acute coronary syndrome (ACS', 'Japanese patients with ACS and hypercholesterolemia', 'Japanese Patients With Acute Coronary Syndrome\u3000', 'Japanese patients recently hospitalized with ACS and hypercholesterolemia', 'Methods\u2004and\u2004Results:Patients (n=206) who at index ACS diagnosis either had low-density lipoprotein cholesterol (LDL-C) ≥2.59 mmol/L (≥100 mg/dL) despite stable statin therapy, or were not on statins with LDL-C levels above target after statin initiation']","['Alirocumab', 'standard of care (SoC; atorvastatin ≥10 mg/day or rosuvastatin', 'alirocumab']","['LDL-C', 'Coronary Atheroma Volume', 'normalized TAV', 'coronary atheroma volume', 'normalized total atheroma volume [TAV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0264683', 'cui_str': 'Coronary artery atheroma (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0264956', 'cui_str': 'Atheromatous Plaques'}]",36.0,0.0474424,W36 absolute change from baseline in percent atheroma volume was -1.3,"[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiovascular Medicine, Kitasato University School of Medicine.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Tsujita', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Hiro', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Iwate Medical University.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Division of Cardiology, Teikyo University Hospital.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Shinke', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Showa University School of Medicine.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Uno', 'Affiliation': 'Cardiovascular Medical, Sanofi.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals, Inc.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Clinical Sciences and Operations, Sanofi.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0412']
1878,26543459,"Comparative study of preoperative use of oral gabapentin, intravenous dexamethasone and their combination in gynaecological procedure.","BACKGROUND
We studied the effects of oral gabapentin and intravenous (I.V.) dexamethasone given together or separately 1 h before the start of surgery on intraoperative hemodynamics Postoperative analgesia and postoperative nausea vomiting (PONV) in patients undergoing gynaecological procedure.
MATERIALS AND METHODS
Patients were randomly divided into three groups: Group 1 (gabapentin, n = 46) received 400 mg gabapentin, Group 2 (dexamethasone, n = 46) received 8 mg dexamethasone and Group 3 (gabapentin plus dexamethasone, n = 46) received both 400 mg gabapentin and 8 mg dexamethasone I.V. 1 h before the start of surgery. Standard induction and maintenance of anesthesia were accomplished. Visual analog scale for pain was recorded for 12 h. Side effects were noted.
RESULTS
Hemodynamics at various time interval (0, 5, 10, 15, 20, 25 and 30 min) of laryngeal mask airway insertion and PONV were found significantly lower in Group 3 than in Group 1 and Group 2 (P < 0.05). The average time to first postoperative analgesic requirement at (visual analogue score >3) was significantly longer in Group 3 (510.00 ± 61.64 min) than in Group 1 (352.83 ± 80.61 min) and in Group 2 (294.78 ± 60.76 min), (P < 0.05).
CONCLUSION
The present study concludes that the combination of oral Gabapentin and I.V. dexamethasone has significantly less hemodynamic changes, better postoperative analgesia and less incidence of PONV than individual administration of each drug.",2015,"The average time to first postoperative analgesic requirement at (visual analogue score >3) was significantly longer in Group 3 (510.00 ± 61.64 min) than in Group 1 (352.83 ± 80.61 min) and in Group 2 (294.78 ± 60.76 min), (P < 0.05).
","['Patients', 'gynaecological procedure', 'patients undergoing gynaecological procedure']","['dexamethasone', '400 mg gabapentin, Group 2 (dexamethasone, n = 46) received 8 mg dexamethasone and Group 3 (gabapentin plus dexamethasone, n = 46) received both 400 mg gabapentin and 8 mg dexamethasone', 'gabapentin and intravenous (I.V.) dexamethasone', 'oral gabapentin, intravenous dexamethasone', 'Group 1 (gabapentin', 'Gabapentin']","['intraoperative hemodynamics Postoperative analgesia and postoperative nausea vomiting (PONV', 'average time to first postoperative analgesic requirement', 'laryngeal mask airway insertion and PONV', 'Visual analog scale for pain', 'hemodynamic changes, better postoperative analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1327728'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0396618', 'cui_str': 'Laryngeal mask airway insertion (procedure)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",,0.0368219,"The average time to first postoperative analgesic requirement at (visual analogue score >3) was significantly longer in Group 3 (510.00 ± 61.64 min) than in Group 1 (352.83 ± 80.61 min) and in Group 2 (294.78 ± 60.76 min), (P < 0.05).
","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Agrawal', 'Affiliation': 'Department of Anesthesiology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Anesthesiology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Khandelwal', 'Affiliation': 'Department of Anesthesiology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Anesthesiology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Madan Mohan', 'Initials': 'MM', 'LastName': 'Gupta', 'Affiliation': 'Department of Radio Diagnosis Clinical Associate DSA, Jaslok Hospital, Mumbai, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159466']
1879,26543460,Evaluating the quality of intravenous regional anesthesia following adding dexamethasone to lidocaine.,"OBJECTIVES
The quality of anesthesia in intravenous regional anesthesia (IVRA) has been evaluated in many studies so far. This study was designed to evaluate the effects of adding the dexamethasone to lidocaine on the quality of IVRA.
MATERIALS AND METHODS
A double-blind clinical trial was set up involving 50 hand surgery candidates, 20 to 55 years old, and with American Society of Anesthesiologists class of I and II. Patients were randomly allocated into two groups of 25 cases and received either 3 mg/kg of lidocaine (control group) or 3 mg/kg of lidocaine plus 8 mg of dexamethasone (study group). The onset and recovery times from sensory and motor blocks, the starting time of tourniquet pain, the amount of narcotics needed during patients' recovery, and probable side-effects were all compared between the two groups.
RESULTS
No significant differences were detected concerning age, gender, length of surgery and the mean time of starting of tourniquet pain between the two groups. The mean times of both sensory (P = 0.002) and motor (P = 0.004) blocks onset were significantly shorter in the study group. The mean time of recovery from sensory block was significantly longer in the study group (P = 0.01). The average amount of narcotics needed during the recovery was significantly lower in the study group (P = 0.01). No side-effect was detected.
CONCLUSION
We conclude that adding the dexamethasone to lidocaine can improve the quality of anesthesia in IVRA.",2015,"No significant differences were detected concerning age, gender, length of surgery and the mean time of starting of tourniquet pain between the two groups.","['50 hand surgery candidates, 20 to 55 years old, and with American Society of Anesthesiologists class of I and II']","['lidocaine (control group) or 3 mg/kg of lidocaine plus 8 mg of dexamethasone', 'lidocaine', 'intravenous regional anesthesia (IVRA', 'dexamethasone']","[""starting time of tourniquet pain, the amount of narcotics needed during patients' recovery, and probable side-effects"", 'mean times of both sensory', 'length of surgery and the mean time of starting of tourniquet pain', 'quality of anesthesia in IVRA', 'mean time of recovery from sensory block', 'average amount of narcotics needed during the recovery', 'quality of IVRA']","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}]","[{'cui': 'C1301880', 'cui_str': 'Start time'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",,0.0457493,"No significant differences were detected concerning age, gender, length of surgery and the mean time of starting of tourniquet pain between the two groups.","[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Hassani', 'Affiliation': 'Department of Anesthesiology, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mahoori', 'Affiliation': 'Department of Anesthesiology, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mir Mousa', 'Initials': 'MM', 'LastName': 'Aghdashi', 'Affiliation': 'Department of Anesthesiology, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Pirnejad', 'Affiliation': 'Department of Health Information Technology, Urmia University of Medical Sciences, Urmia, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159467']
1880,26543461,Effect of preinduction low-dose ketamine bolus on intra operative and immediate postoperative analgesia requirement in day care surgery: A randomized controlled trial.,"BACKGROUND
Availability of narcotics is an issue in developing countries, and low-dose ketamine offers an alternative to these drugs.
OBJECTIVE
The objective of this study is to evaluate the effect of a preemptive dose of low-dose ketamine on intra operative and the immediate postoperative analgesic requirements.
DESIGN
Randomized double-blind control trial.
SETTINGS
This study has been performed in the operating rooms and postanesthesia care unit at Aga Khan University Hospital, Karachi, Pakistan.
MATERIALS AND METHODS
Totally, 60 adult American Society of Anesthesiologists I and II patients undergoing day care surgery were randomly allocated into two groups, Group A (ketamine group) and Group B (saline group).
INTERVENTION
All patients underwent general anesthesia. Propofol 2 mg/kg was used as an induction agent; laryngeal mask airway (size 3 for females and 4 for males) was inserted. Following induction patients in Group A received ketamine 0.3 mg/kg and Group B saline bolus in a blinded manner. All patients were administered injection fentanyl 1 μg/kg as an analgesic and anesthesia was maintained with oxygen 40%, nitrous oxide 60% and isoflorane 1-2 minimum alveolar concentration. Patients breathed spontaneously on Lack circuit. Postoperatively rescue analgesia was provided with intravenous morphine 0.1 mg/kg when patient complained of pain.
MAIN OUTCOME MEASURES
We observed analgesic effects of low-dose ketamine intra operatively and narcotic requirements in immediate postoperative period for day care surgeries.
RESULTS
There was no significant difference in demographic data in between groups. Saline group required more rescue analgesia (morphine) postoperatively (P < 0.001). No significant psychotomimetic symptoms were noted in either group.
CONCLUSION
Low-dose ketamine 0.3 mg/kg provided adequate co-analgesia with fentanyl 1 μg/kg and was effective in a reduction of morphine requirement in the postoperative phase with minimal adverse effects.",2015,provided adequate co-analgesia with fentanyl 1 μg/kg and was effective in a reduction of morphine requirement in the postoperative phase with minimal adverse effects.,"['day care surgery', 'Totally, 60 adult American Society of Anesthesiologists I and II patients undergoing day care surgery', 'operating rooms and postanesthesia care unit at Aga Khan University Hospital, Karachi, Pakistan']","['morphine', 'Propofol', 'Low-dose ketamine', 'preinduction low-dose ketamine', 'injection fentanyl', 'general anesthesia', 'low-dose ketamine', 'Group A (ketamine group) and Group B (saline group', 'ketamine 0.3 mg/kg and Group B saline', 'analgesic and anesthesia was maintained with oxygen 40%, nitrous oxide 60% and isoflorane 1-2 minimum alveolar concentration', 'ketamine', 'Saline']","['analgesic effects', 'demographic data', 'rescue analgesia', 'psychotomimetic symptoms']","[{'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1305682', 'cui_str': 'Oxygen 40 %'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.422982,provided adequate co-analgesia with fentanyl 1 μg/kg and was effective in a reduction of morphine requirement in the postoperative phase with minimal adverse effects.,"[{'ForeName': 'Khalid Maudood', 'Initials': 'KM', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Anesthesiology, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Fauzia Anis', 'Initials': 'FA', 'LastName': 'Khan', 'Affiliation': 'Department of Anesthesiology, Aga Khan University, Karachi, Pakistan.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159468']
1881,26543463,"Combination of dexmedetomidine and remifentanil for labor analgesia: A double-blinded, randomized, controlled study.","BACKGROUND
Satisfactory analgesia is of great importance in the labor. The clinical efficacy and side effects of remifentanil in the management of labor pain had been evaluated. Dexmedetomidine (DMET) demonstrates an antinociceptive effect in visceral pain conditions. Aims of the study were to assess whether the combination of DMET with remifentanil would produce a synergistic effect that results in lower analgesic requirements. Furthermore, whether this combination would have less maternal and neonatal adverse effects.
PATIENTS AND METHODS
Sixty American Society of Anesthesiologists physical status I-II pregnant women had been enrolled into this study. All were full term (37-40 weeks' gestation), singleton fetus with cephalic presentation in the first stage of spontaneous labor. They were divided into two groups group (I) Patient-controlled IV remifentanil analgesia (bolus dose 0.25 μg/kg, lockout interval 2 min) increased by 0.25 μg/kg to a maximum bolus dose 1 μg/kg in addition to a loading dose of DMET 1 μg/kg over 20 min, followed by infusion at 0.5 μg/kg/h group (II) Patient-controlled IV remifentanil analgesia (PCA) (bolus dose 0.25 μg/kg, lockout interval 2 min) increased by 0.25 μg/kg to a maximum bolus dose 1 μg/kg in addition to a the same volume of normal saline as a loading dose, followed by a continuous saline infusion. Visual analog scale score, maternal, and fetal complications and patients' satisfaction were recorded.
RESULTS
Patients receiving a combination of PCA remifentanil and DMET had a lower pain score compared with remifentanil alone in the second stage of labor (P = 0.001). The Total consumption of remifentanil was reduced by 53.3% in group I. There was an increased incidence of maternal complications and a lower patient satisfaction score in group II.
CONCLUSION
DMET has an opioid sparing effect; a combination of DMET and remifentanil produces a synergistic effect that results in lower analgesic requirements and less maternal and neonatal adverse events.",2015,"There was an increased incidence of maternal complications and a lower patient satisfaction score in group II.
","['Sixty American Society of Anesthesiologists physical status I-II pregnant women had been enrolled into this study', 'labor analgesia']","['dexmedetomidine and remifentanil', 'Patient-controlled IV remifentanil analgesia (bolus dose 0.25 μg/kg, lockout interval 2 min) increased by 0.25 μg/kg to a maximum bolus dose 1 μg/kg in addition to a loading dose of DMET 1 μg/kg over 20 min, followed by infusion at 0.5 μg/kg/h group (II) Patient-controlled IV remifentanil analgesia (PCA', 'Dexmedetomidine (DMET', 'PCA remifentanil and DMET', 'remifentanil']","['patient satisfaction score', 'Total consumption of remifentanil', 'pain score', 'incidence of maternal complications', ""Visual analog scale score, maternal, and fetal complications and patients' satisfaction"", 'labor pain']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0851390', 'cui_str': 'Foetal complications'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}]",60.0,0.453847,"There was an increased incidence of maternal complications and a lower patient satisfaction score in group II.
","[{'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Abdalla', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mona Ahmed', 'Initials': 'MA', 'LastName': 'Ammar', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ayman Ibrahim', 'Initials': 'AI', 'LastName': 'Tharwat', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159470']
1882,32416495,Changing the future: An initial test of Future Specificity Training (FeST).,"A range of psychiatric disorders are characterised by impairments in episodic future thinking (EFT), and particularly simulating specific, spatiotemporally-located future events. No study has examined whether training can lead to sustained improvement in specific EFT. In this study, participants (N = 60; M age = 31, SD = 13.2) were randomized to a two-session, group-based future thinking program (Future Specificity Training; FeST) or wait-list. At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (d = 1.32), use of mental imagery (d = 1.32), anticipated (d = 1.78) and anticipatory pleasure (d = 1.07), perceived control (d = 1.20), and likelihood of occurrence (d = 1.09). Some effects were also observed on positive, generalised future self-states. In the context of inherent limitations of subjective reporting in trials, this study provides evidence that EFT specificity can be enhanced, and the effects of FeST indicate a possible avenue to disrupt psychopathological processes.",2020,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","['participants (N\xa0=\xa060; M age\xa0=\xa031, SD\xa0=\xa013.2']","['group-based future thinking program (Future Specificity Training; FeST) or wait-list', 'Future Specificity Training (FeST']","['anticipatory pleasure', 'detail ', 'ability to mentally simulate specific EFT']","[{'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0143698,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hallford', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia. Electronic address: david.hallford@deakin.edu.au.'}, {'ForeName': 'J J E', 'Initials': 'JJE', 'LastName': 'Yeow', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fountas', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Herrick', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven, Tiensestraat 102, Box 3712, 3000, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""D'Argembeau"", 'Affiliation': 'Psychology and Neuroscience of Cognition Research Unit, Department of Psychology, University of Liège, Belgium and Fonds de La Recherche Scientifique (F.R.S.-FNRS), Belgium.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103638']
1883,32492302,"Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children.","BACKGROUND
Rituximab added to chemotherapy prolongs survival among adults with B-cell cancer. Data on its efficacy and safety in children with high-grade, mature B-cell non-Hodgkin's lymphoma are limited.
METHODS
We conducted an open-label, international, randomized, phase 3 trial involving patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B (LMB) chemotherapy with standard LMB chemotherapy alone. The primary end point was event-free survival. Overall survival and toxic effects were also assessed.
RESULTS
Analyses were based on 328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma. The median follow-up was 39.9 months. Events were observed in 10 patients in the rituximab-chemotherapy group and in 28 in the chemotherapy group. Event-free survival at 3 years was 93.9% (95% confidence interval [CI], 89.1 to 96.7) in the rituximab-chemotherapy group and 82.3% (95% CI, 75.7 to 87.5) in the chemotherapy group (hazard ratio for primary refractory disease or first occurrence of progression, relapse after response, death from any cause, or second cancer, 0.32; 95% CI, 0.15 to 0.66; one-sided P = 0.00096, which reached the significance level required for this analysis). Eight patients in the rituximab-chemotherapy group died (4 deaths were disease-related, 3 were treatment-related, and 1 was from a second cancer), as did 20 in the chemotherapy group (17 deaths were disease-related, and 3 were treatment-related) (hazard ratio, 0.36; 95% CI, 0.16 to 0.82). The incidence of acute adverse events of grade 4 or higher after prephase treatment was 33.3% in the rituximab-chemotherapy group and 24.2% in the chemotherapy group (P = 0.07); events were related mainly to febrile neutropenia and infection. Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
CONCLUSIONS
Rituximab added to standard LMB chemotherapy markedly prolonged event-free survival and overall survival among children and adolescents with high-grade, high-risk, mature B-cell non-Hodgkin's lymphoma and was associated with a higher incidence of hypogammaglobulinemia and, potentially, more episodes of infection. (Funded by the Clinical Research Hospital Program of the French Ministry of Health and others; ClinicalTrials.gov number, NCT01516580.).",2020,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","['adults with B-cell cancer', ""children with high-grade, mature B-cell non-Hodgkin's lymphoma"", ""328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma"", ""High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children"", ""patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B ""]","['standard LMB chemotherapy', 'Rituximab', 'LMB) chemotherapy with standard LMB chemotherapy alone', 'rituximab-chemotherapy']","['Event-free survival', 'efficacy and safety', 'incidence of acute adverse events', 'febrile neutropenia and infection', 'prolonged event-free survival and overall survival', 'event-free survival', 'Overall survival and toxic effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",328.0,0.163524,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pillon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'G A Amos', 'Initials': 'GAA', 'LastName': 'Burke', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Barkauskas', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Delgado', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyttebroeck', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Zsiros', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Csoka', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Bernarda', 'Initials': 'B', 'LastName': 'Kazanowska', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Chiang', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rodney R', 'Initials': 'RR', 'LastName': 'Miles', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wotherspoon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Adamson', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Patte', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915315']
1884,32492654,The Placebo Effect in Sport: How Practitioners Can Inject Words to Improve Performance.,,2020,,['Sport'],['Placebo'],[],"[{'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.105088,,"[{'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Roelands', 'Affiliation': 'Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hurst', 'Affiliation': 'Canterbury Christ Church University, United Kingdom.'}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0358']
1885,27375377,Depth of insertion of right internal jugular central venous catheter: Comparison of topographic and formula methods.,"BACKGROUND
Central venous catheters (CVCs) are inserted in many critically ill patients, but there is no gold standard in estimating their approximate depth of insertion. Many techniques have been described in literature. In this study, we compare the topographic method with the standard formula technique.
MATERIALS AND METHODS
260 patients, in whom central venous catheterization was warranted, were randomly assigned to either topographic method or formula method (130 in each group). The position of the CVC tip in relation to carina was measured on a postprocedure chest X-ray. The primary endpoint was the need for catheter repositioning.
RESULTS
The majority of the CVCs tips positioned by the formula method were situated below the carina, and 68% of these catheters required repositioning after obtaining postprocedure chest X-ray (P < 0.001).
CONCLUSION
The topographic method is superior to formula approach in estimating the depth of insertion of right internal jugular CVCs.",2016,The topographic method is superior to formula approach in estimating the depth of insertion of right internal jugular CVCs.,"['260 patients, in whom central venous catheterization was warranted']","['topographic method or formula method', 'Central venous catheters (CVCs']",['need for catheter repositioning'],"[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007435', 'cui_str': 'Central Catheterization'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]",260.0,0.0561858,The topographic method is superior to formula approach in estimating the depth of insertion of right internal jugular CVCs.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vinay', 'Affiliation': 'Department of Anesthesiology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Tejesh', 'Affiliation': 'Department of Anesthesiology, MS Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.174904']
1886,27375378,To determine block establishment time of supraclavicular brachial plexus block using blunt versus short bevel needle: A prospective randomized trial.,"BACKGROUND
Unintentional intraneural injection under ultrasound guidance (USG) with fine caliber needles and lower success rate with large caliber Tuohy needles in supraclavicular brachial plexus block (SCB) have been reported.
MATERIALS AND METHODS
We undertook study to standardize the use of 20-gauge short versus blunt bevel needle for SCB. After approval of Institutional Ethics Committee and written informed consent, patients were randomized using computer-generated random number table to either of the two groups; blunt bevel needle group (n = 30): SCB under USG using 20-gauge Tuohy needle or short bevel needle group (n = 30): SCB under USG using 20-gauge short bevel needle. The primary outcome of the study was time to establishment of sensory and motor block of individual nerves, and secondary outcome was tolerability and any adverse effects.
RESULTS
The time to establishment of sensory and motor block in individual nerve territory was similar in both the groups. The complete sensory and motor anesthesia was achieved in 78.3% patients and complete sensory and motor anesthesia after supplementary block was achieved in 86.6% patients. Paresthesias during SCB were recorded in 15 patients. Out of these eight patients were of blunt bevel group and seven patients were of short bevel group. None of the patients experienced any neurological adverse effects.
CONCLUSION
The establishment of sensory and motor blockade of individual nerves was similar to 20-gauge short and blunt bevel needle under ultrasound guide with no neurological adverse events.",2016,The complete sensory and motor anesthesia was achieved in 78.3% patients and complete sensory and motor anesthesia after supplementary block was achieved in 86.6% patients.,['supraclavicular brachial plexus block (SCB'],"['supraclavicular brachial plexus block using blunt versus short bevel needle', '20-gauge short versus blunt bevel needle for SCB', 'Unintentional intraneural injection under ultrasound guidance (USG) with fine caliber needles', 'SCB under USG using 20-gauge Tuohy needle or short bevel needle group', 'SCB under USG using 20-gauge short bevel needle']","['time to establishment of sensory and motor block of individual nerves, and secondary outcome was tolerability and any adverse effects', 'neurological adverse effects', 'time to establishment of sensory and motor block', 'Paresthesias during SCB', 'complete sensory and motor anesthesia']","[{'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach (procedure)'}]","[{'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach (procedure)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C1719894', 'cui_str': 'Short bevel needle'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1720515', 'cui_str': 'Bevel needle'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0184186', 'cui_str': 'Tuohy epidural needle'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]",8.0,0.0332778,The complete sensory and motor anesthesia was achieved in 78.3% patients and complete sensory and motor anesthesia after supplementary block was achieved in 86.6% patients.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ahuja', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thapa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gombar', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dhiman', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.174910']
1887,27375379,"Lung ultrasound versus chest radiography for the diagnosis of pneumothorax in critically ill patients: A prospective, single-blind study.","BACKGROUND
Radiologic data remains the gold standard for the diagnosis of pneumothorax (PTX). The use of ultrasonography (US) has recently emerged as the method of choice with physicians who can perform bedside US.
PURPOSE
To compare the diagnostic accuracy of lung US against bedside chest radiography (CR) for the detection of PTX using thoracic computed tomography (CT) as the gold standard.
MATERIALS AND METHODS
We conducted a prospective, single-blind study on 192 critically ill patients; each patient received lung US examination, bedside CR, followed by thoracic CT scan searching for PTX.
RESULTS
Of the studied patients, CT of the chest confirmed the diagnosis of PTX in 36 (18.75%) patients of which 31 were diagnosed by thoracic US while CR detected only 19 cases. Overall lung US showed a considerable higher sensitivity than bedside CR (86.1% vs. 52.7%), lung US also showed higher, negative predictive values, and diagnostic accuracy against CR (96.8% vs. 90.1%), and (95.3% vs. 90.6%), respectively. CR had a slightly higher specificity than lung US (99.4% vs. 97.4%), and higher positive predictive values (95.0% vs. 88.6%).
CONCLUSION
Lung US is an accurate modality more than anteroposterior bedside CR in comparison with CT scanning when evaluating critically ill mechanically ventilated patients, patients underwent thoracocentesis, central venous catheter insertion, or patients with polytrauma.",2016,"Overall lung US showed a considerable higher sensitivity than bedside CR (86.1% vs. 52.7%), lung US also showed higher, negative predictive values, and diagnostic accuracy against CR (96.8% vs. 90.1%), and (95.3% vs. 90.6%), respectively.","['192 critically ill patients', 'critically ill patients']","['lung US examination, bedside CR, followed by thoracic CT scan searching for PTX', 'lung US against bedside chest radiography (CR', 'PTX using thoracic computed tomography (CT', 'Lung ultrasound versus chest radiography', 'CT scanning', 'ultrasonography (US']","['negative predictive values, and diagnostic accuracy against CR', 'positive predictive values', 'diagnosis of PTX']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",192.0,0.0618676,"Overall lung US showed a considerable higher sensitivity than bedside CR (86.1% vs. 52.7%), lung US also showed higher, negative predictive values, and diagnostic accuracy against CR (96.8% vs. 90.1%), and (95.3% vs. 90.6%), respectively.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Abdalla', 'Affiliation': 'Department of Anesthesia, Intensive Care, and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Elgendy', 'Affiliation': 'Department of Anesthesia, Intensive Care, and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Abdelaziz', 'Affiliation': 'Department of Anesthesia, Intensive Care, and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ammar', 'Affiliation': 'Department of Anesthesia, Intensive Care, and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.174906']
1888,27375381,"Controlled hypotension in day care functional endoscopic sinus surgery: A comparison between esmolol and dexmedetomidine: A prospective, double-blind, and randomized study.","BACKGROUND
Functional endoscopic sinus surgery (FESS) is the cornerstone of therapeutic management for nasal pathologies. This study is to compare the ability of preoperative and intraoperative esmolol versus dexmedetomidine for producing induced hypotension during FESS in adults in a day care setting.
MATERIALS AND METHODS
Sixty patients (20-45 years) posted for FESS under general anesthesia were randomly divided into Group E (n = 30) receiving esmolol, loading dose 1 mg/kg over 1 min followed by 0.5 mg/kg/h infusion during maintenance and Group D (n = 30) receiving dexmedetomidine 1 μg/kg over 15 min before induction of anesthesia followed by 0.5 μg/Kg/h infusion during maintenance, respectively. Nasal bleeding and Surgeon's satisfaction score; amount and number of patients receiving fentanyl and nitroglycerine for analgesia and deliberate hypotension, Postanesthesia Care Unit (PACU) and hospital stay; hemodynamic parameters and side effects were recorded for each patient.
RESULTS
Significantly less number and dosage of nitroglycerine was required (P = 0.0032 and 0.0001, respectively) in Group D compared to that in Group E. Again the number and dosage of patients requiring fentanyl were significantly lower in Group D. However, the duration of controlled hypotension was almost similar in both the groups. Group D patients suffered from significantly less nasal bleeding, and surgeon's satisfaction score was also high in this group. Discharge from PACU and hospital were significantly earlier in Group D. Intraoperative hemodynamics were quite comparable (P > 0.05) without any appreciable side effects.
CONCLUSION
Dexmedetomidine found to be providing more effectively controlled hypotension and analgesia and thus allowing less nasal bleeding as well as more surgeons' satisfaction score.",2016,"Significantly less number and dosage of nitroglycerine was required (P = 0.0032 and 0.0001, respectively) in Group D compared to that in Group E. Again the number and dosage of patients requiring fentanyl were significantly lower in Group D.","['Sixty patients (20-45 years) posted for FESS under general anesthesia', 'day care functional endoscopic sinus surgery', 'adults in a day care setting']","['esmolol', 'fentanyl and nitroglycerine', 'Dexmedetomidine', 'Controlled hypotension', 'esmolol and dexmedetomidine', 'esmolol, loading dose 1 mg/kg over 1 min followed by 0.5 mg/kg/h infusion during maintenance and Group D', 'Functional endoscopic sinus surgery (FESS', 'dexmedetomidine']","[""nasal bleeding, and surgeon's satisfaction score"", 'analgesia and deliberate hypotension, Postanesthesia Care Unit (PACU) and hospital stay; hemodynamic parameters and side effects', 'nasal bleeding', ""Nasal bleeding and Surgeon's satisfaction score"", 'number and dosage of nitroglycerine', 'duration of controlled hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}]","[{'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}]",60.0,0.0389788,"Significantly less number and dosage of nitroglycerine was required (P = 0.0032 and 0.0001, respectively) in Group D compared to that in Group E. Again the number and dosage of patients requiring fentanyl were significantly lower in Group D.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chhaule', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Basunia', 'Affiliation': 'Department of Anesthesiology, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Halder', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mandal', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.174919']
1889,32415471,Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial.,"PURPOSE
Primary dysmenorrhea is the most common gynecological problem in young women and adolescents. Exercise therapy provides positive effects on women with primary dysmenorrhea. The aim of the study was to investigate the effects of a combined exercise program on pain, sleep and menstrual symptoms in patients with primary dysmenorrhea.
METHODS
The study is a randomized controlled study. The study included 28 sedentary individuals. The participants were assigned to two groups as the exercise (mean age 22.9 ± 2.0 years) and the control (mean age 23.1 ± 1.8 years) groups. The exercise protocol was carried out with the exercise group three times a week for eight weeks. The Visual Analog Scale (VAS) was used for assessing the intensity of pain. The Menstrual Symptom Questionnaire (MSQ) and Pittsburgh Sleep Quality Index (PSQI) were used for evaluating menstrual symptoms and sleep quality, respectively. The study was registered on the Clinical Trials website by the number NCT03625375.
RESULTS
The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05). The intragroup comparisons of the exercise group demonstrated that the scores of the low back pain and abdominal pain and the MSQ and PSQI scores were found to be significantly different after the 8-week program (p < 0.05).
CONCLUSION
The combined exercise therapy is an effective way to manage symptoms associated with primary dysmenorrhea.",2020,"The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05).","['young women and adolescents', 'patients with primary dysmenorrhea', 'women with primary dysmenorrhea', '28 sedentary individuals']","['functional exercises', 'combined exercise program', 'Exercise therapy', 'combined exercise therapy']","['Visual Analog Scale (VAS', 'Menstrual Symptom Questionnaire (MSQ) and Pittsburgh Sleep Quality Index (PSQI', 'low back pain and abdominal pain and the MSQ and PSQI scores', 'pain, sleep and menstrual symptoms', 'abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods', 'menstrual symptoms and sleep quality', 'pain and sleep quality']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",28.0,0.0352192,"The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05).","[{'ForeName': 'Berkiye', 'Initials': 'B', 'LastName': 'Kirmizigil', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, via Mersin-10, Turkey. berkiye.kirmizigil@emu.edu.tr.'}, {'ForeName': 'Cisel', 'Initials': 'C', 'LastName': 'Demiralp', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, via Mersin-10, Turkey.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05579-2']
1890,32492293,A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.,"BACKGROUND
Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown.
METHODS
We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.
RESULTS
We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was -2.4 percentage points (95% confidence interval, -7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
CONCLUSIONS
After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.).",2020,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","['United States and parts of Canada testing', '821 asymptomatic participants', 'enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure']","['placebo', 'Hydroxychloroquine', 'placebo or hydroxychloroquine', 'hydroxychloroquine']","['Side effects', 'incidence of new illness compatible with Covid-19', 'incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days', 'serious adverse reactions']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0454979', 'cui_str': 'Part of Canada'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0028798', 'cui_str': 'Exposure, Occupational'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",821.0,0.751633,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'LaBar', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}]",The New England journal of medicine,['10.1056/NEJMoa2016638']
1891,32492688,"Prior Therapeutic Experiences, Not Expectation Ratings, Predict Placebo Effects: An Experimental Study in Chronic Pain and Healthy Participants.","INTRODUCTION
Many clinical trials fail because of placebo responses. Prior therapeutic experiences and patients' expectations may affect the capacity to respond to placebos in chronic disorders.
OBJECTIVE
The scope of this study in 763 chronic orofacial pain and healthy study participants was to compare the magnitude and prevalence of placebo effects and determine the putative role of prior therapeutic experiences vs. expectations.
METHODS
We tested placebo propensity in a laboratory setting by using 2 distinct levels of individually tailored painful stimulations (high pain and low pain) to reinforce expectations and provide a hypoalgesic experience (conditioning phase). Afterwards, both levels of pain were surreptitiously set at a moderate pain level to test for placebo effects (testing phase). Pain and expectation ratings were assessed as primary outcomes using visual analog scales.
RESULTS
In both chronic pain and healthy participants, placebo effects were similar in magnitude, with the larger prevalence of responders in the healthy participants. Although chronic pain participants reported higher pain relief expectations, expectations did not account for the occurrence of placebo effects. Rather, prior experience via conditioning strength mediated placebo effects in both pain and healthy participants.
CONCLUSIONS
These findings indicate that participants with chronic pain conditions display robust placebo effects that are not mediated by expectations but are instead directly linked to prior therapeutic experiences. This confirms the importance of assessing the therapeutic history while raising questions about the utility of expectation ratings. Future research is needed to enhance prediction of responses to placebos, which will ultimately improve clinical trial designs.",2020,"In both chronic pain and healthy participants, placebo effects were similar in magnitude, with the larger prevalence of responders in the healthy participants.","['763 chronic orofacial pain and healthy study participants', 'Chronic Pain and Healthy Participants', 'participants with chronic pain conditions', 'pain and healthy participants']",['placebo'],"['pain relief expectations', 'Pain and expectation ratings', 'visual analog scales']","[{'cui': 'C4546211', 'cui_str': 'Chronic orofacial pain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",763.0,0.306134,"In both chronic pain and healthy participants, placebo effects were similar in magnitude, with the larger prevalence of responders in the healthy participants.","[{'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA, colloca@umaryland.edu.'}, {'ForeName': 'Titilola', 'Initials': 'T', 'LastName': 'Akintola', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Nathaniel R', 'Initials': 'NR', 'LastName': 'Haycock', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Maxie', 'Initials': 'M', 'LastName': 'Blasini', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Corsi', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Lieven A', 'Initials': 'LA', 'LastName': 'Schenk', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000507400']
1892,27375382,Arthroscopic medial meniscus trimming or repair under nerve blocks: Which nerves should be blocked?,"BACKGROUND
This study aimed to determine the role of the sciatic and obturator nerve blocks (in addition to femoral block) in providing painless arthroscopic medial meniscus trimming/repair.
MATERIALS AND METHODS
One hundred and twenty patients with medial meniscus tear, who had been scheduled to knee arthroscopy, were planned to be included in this controlled prospective double-blind study. The patients were randomly allocated into three equal groups; FSO, FS, and FO. The femoral, sciatic, and obturator nerves were blocked in FSO groups. The femoral and sciatic nerves were blocked in FS group, while the femoral and obturator nerves were blocked in FO group. Intraoperative pain and its causative surgical maneuver were recorded.
RESULTS
All the patients (n = 7, 100%) in FO group had intraoperative pain. The research was terminated in this group but completed in FS and FSO groups (40 patients each). During valgus positioning of the knee for surgical management of the medial meniscus tear, the patients in FS group experienced pain more frequently than those in FSO group (P = 0.005).
CONCLUSION
Adding a sciatic nerve block to the femoral nerve block is important for painless knee arthroscopy. Further adding of an obturator nerve block may be needed when a valgus knee position is required to manage the medial meniscus tear.",2016,"All the patients (n = 7, 100%) in FO group had intraoperative pain.","['painless knee arthroscopy', 'One hundred and twenty patients with medial meniscus tear, who had been scheduled to knee arthroscopy']","['FSO, FS, and FO', 'Arthroscopic medial meniscus trimming or repair under nerve blocks', 'FSO']","['pain', 'intraoperative pain', 'Intraoperative pain', 'femoral and sciatic nerves', 'femoral, sciatic, and obturator nerves']","[{'cui': 'C0234226', 'cui_str': 'Painless (qualifier value)'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348073', 'cui_str': 'Medial Menisci'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0348073', 'cui_str': 'Medial Menisci'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0036394', 'cui_str': 'Sciatic Nerve'}, {'cui': 'C0028783', 'cui_str': 'Obturator Nerve'}]",120.0,0.0422409,"All the patients (n = 7, 100%) in FO group had intraoperative pain.","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Taha', 'Affiliation': 'Department of Anesthesia, Abu Dhabi Knee and Sports Center, Madinat Zayed, Abu Dhabi, UAE.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Abd-Elmaksoud', 'Affiliation': 'Department of Anesthesia, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.174912']
1893,27375383,Intraoperative effect of dexmedetomidine infusion during living donor liver transplantation: A randomized control trial.,"BACKGROUND
Dexmedetomidine hydrochloride (Dex) is a useful adjuvant for general anesthesia. The aim was to evaluate the effects of Dex infusion during living donors liver transplantation (LDLT) on the general anesthetic requirements, hemodynamics, oxygen consumption (VO2), and CO2 production (VCO2).
MATERIALS AND METHODS
Forty LDLT recipients were allocated randomly to receive either Dex (0.2-0.7 μg/kg/h) or placebo (control [C]). Patient state index (PSI), SEDLine monitored anesthesia depth (25-50) with desflurane (Des) % and fentanyl altered accordingly. Transesophageal Doppler (TED), invasive mean arterial blood pressure (MAP) and heart rate (HR) were monitoring any Dex side effects and altering infusion rate accordingly; TED was used for fluid optimization. Metabolic gas monitoring (VO2, VCO2) and Des consumption were recorded.
RESULTS
Dex reduced Des and fentanyl consumption versus C (120.0 ± 30.2 vs. 248.0 ± 38.8) ml, (440.0 ± 195.74 vs. 1300.0 ± 32) μg, respectively (P < 0.01). Dex was delivered for 11.35 ± 2.45 h with comparable HR, MAP, and TED variables versus C and with similar mean noradrenaline support (5.63 ± 2.44 vs. 5.83 ± 2.57 mg, P = 0.81). VO2 was reduced with Dex vs. C during anhepatic, 30 min postreperfusion and end of surgery (193.2 ± 26.78 vs. 239 ± 14.93) (172.1 ± 28.14 vs. 202.7 ± 18.03) and (199.7 ± 26.63 vs. 283.8 ± 14.83) ml/min/m(2) respectively (P < 0.01). VCO2 was also reduced with Dex versus C during the same periods (195.2 ± 46.41 vs. 216.7 ± 29.90, P = 0.09), (210.6 ± 60.71 vs. 253.9 ± 32.51, P = 0.01), and (158.7 ± 49.96 vs. 209.7 ± 16.78, P < 0.01), ml/min/m(2) respectively.
CONCLUSION
TED and PSI guided Dex infusion helped to reduce Des and fentanyl consumption as well as VO2 and VCO2 at a lower cost with no adverse effects on hemodynamics.",2016,TED and PSI guided Dex infusion helped to reduce Des and fentanyl consumption as well as VO2 and VCO2 at a lower cost with no adverse effects on hemodynamics.,"['Forty LDLT recipients', 'living donor liver transplantation']","['dexmedetomidine infusion', 'placebo', 'desflurane (Des) % and fentanyl', 'Dex infusion during living donors liver transplantation (LDLT', 'Dex', 'Dexmedetomidine hydrochloride (Dex']","['hemodynamics, oxygen consumption (VO2), and CO2 production (VCO2', 'Patient state index (PSI), SEDLine monitored anesthesia depth', 'Metabolic gas monitoring (VO2, VCO2) and Des consumption', 'VCO2', 'Transesophageal Doppler (TED), invasive mean arterial blood pressure (MAP) and heart rate (HR', 'VO2']","[{'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0752310', 'cui_str': 'Dexmedetomidine Hydrochloride'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0033268'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0522518', 'cui_str': 'Transesophageal approach (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.106933,TED and PSI guided Dex infusion helped to reduce Des and fentanyl consumption as well as VO2 and VCO2 at a lower cost with no adverse effects on hemodynamics.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sayed', 'Affiliation': 'Department of Anesthesia, National Liver Institute, Menoufia University, Egypt.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Yassen', 'Affiliation': 'Department of Anesthesia, National Liver Institute, Menoufia University, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.174914']
1894,27375385,Comparative effect of propofol versus sevoflurane on renal ischemia/reperfusion injury after elective open abdominal aortic aneurysm repair.,"BACKGROUND
Renal injury is a common cause of morbidity and mortality after elective abdominal aortic aneurysm (AAA) repair. Propofol has been reported to protect several organs from ischemia/reperfusion (I/R) induced injury. We performed a randomized clinical trial to compare propofol and sevoflurane for their effects on renal I/R injury in patients undergoing elective AAA repair.
MATERIALS AND METHODS
Fifty patients scheduled for elective AAA repair were randomized to receive propofol anesthesia in group I or sevoflurane anesthesia in group II. Urinary specific kidney proteins (N-acetyl-beta-glucosamidase, alpha-1-microglobulin, glutathione transferase [GST]-pi, GST-alpha) were measured within 5 min of starting anesthesia as a base line (T0), at the end of surgery (T1), 8 h after surgery (T2), 16 h after surgery (T3), and 24 h postoperatively (T4). Serum pro-inflammatory cytokines (tumor necrosis factor-α and interleukin 1-β) were measured at the same time points. In addition, serum creatinine and cystatin C were measured before starting surgery as a baseline and at days 1, 3, and 6 after surgery.
RESULTS
Postoperative urinary concentrations of all measured kidney specific proteins and serum pro-inflammatory cytokines were significantly lower in the propofol group. In addition, the serum creatinine and cystatin C were significantly lower in the propofol group compared with the sevoflurane group.
CONCLUSION
Propofol significantly reduced renal injury after elective open AAA repair and this could have clinical implications in situations of expected renal I/R injury.",2016,"RESULTS
Postoperative urinary concentrations of all measured kidney specific proteins and serum pro-inflammatory cytokines were significantly lower in the propofol group.","['Fifty patients scheduled for elective AAA repair', 'elective abdominal aortic aneurysm (AAA) repair', 'patients undergoing elective AAA repair', 'after elective open abdominal aortic aneurysm repair']","['Propofol', 'propofol and sevoflurane', 'propofol', 'propofol anesthesia', 'sevoflurane', 'sevoflurane anesthesia']","['Urinary specific kidney proteins (N-acetyl-beta-glucosamidase, alpha-1-microglobulin, glutathione transferase [GST]-pi, GST-alpha', 'Serum pro-inflammatory cytokines (tumor necrosis factor-α and interleukin 1-β', 'kidney specific proteins and serum pro-inflammatory cytokines', 'renal injury', 'renal ischemia/reperfusion injury', 'serum creatinine and cystatin C']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0162871', 'cui_str': 'Aortic Aneurysm, Abdominal'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C2939113', 'cui_str': 'Alpha 1 microglobulin'}, {'cui': 'C0017837', 'cui_str': 'Glutathione Organic Nitrate Ester Reductase'}, {'cui': 'C0769262', 'cui_str': 'GST-alpha'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney (disorder)'}, {'cui': 'C0920646', 'cui_str': 'Ischemia of kidney (disorder)'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-Reperfusion Injury'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}]",50.0,0.09551,"RESULTS
Postoperative urinary concentrations of all measured kidney specific proteins and serum pro-inflammatory cytokines were significantly lower in the propofol group.","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Ammar', 'Affiliation': 'Department of Anesthesiology, Minoufiya Faculty of Medicine, Minoufiya University, Egypt.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Anesthesiology, Minoufiya Faculty of Medicine, Minoufiya University, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.174907']
1895,27404645,Baseline Predictors of Singular Action Among Participants With Multiple Health Behavior Risks.,"PURPOSE
Previous studies found that treatment effects can change two behaviors, but not one. This study examined baseline transtheoretical model constructs as three alternative predictors (stage of change, effort, and severity) of singular action among participants with co-occurring health behavior risks.
DESIGN
The study examined participants at risk for three pairs of behaviors (sun and smoking; smoking and diet; and diet and sun). Analyses were conducted with participants who changed only one behavior in a pair (singular action).
SETTING
School and home-based behavior change programs recruited participants via schools, worksites, and physician practices. School, worksite, medical, and home-based prevention programs were the study setting.
SUBJECTS
The sample (N = 3213) was age 44.6 years (SD, 11.1 years), 94.6% white, and 63.7% female.
MEASURES
Stages of change, effort, and severity variables were measured.
ANALYSIS
Pooled data were analyzed using logistic regressions from three randomized controlled trials.
RESULTS
Across all three behaviors, stage of change, effort, and severity effects were consistently related to behavior change at 24 months. Change efforts on one behavior were related to change on another behavior. Baseline sun severity (odds ratio, .97 [.94, 1.00]; p = .046) and smoking severity (odds ratio, .89 [.80, .98]; p = .019) were significant predictors of change on diet at final follow-up.
CONCLUSION
Stage of change was the biggest predictor. Problem severity was the smallest predictor of change at 2-year follow-up. Four of six predictors were within behaviors, whereas two were between.",2016,"Across all three behaviors, stage of change, effort, and severity effects were consistently related to behavior change at 24 months.","['participants with co-occurring health behavior risks', 'participants who changed only one behavior in a pair (singular action', 'change programs recruited participants via schools, worksites, and physician practices', 'School and home-based behavior', 'The sample (N = 3213) was age 44.6 years (SD, 11.1 years), 94.6% white, and 63.7% female', 'Participants With Multiple Health Behavior Risks', 'participants at risk for three pairs of behaviors (sun and smoking; smoking and diet; and diet and sun']",[],['smoking severity'],"[{'cui': 'C0018687'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",[],"[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",1.0,0.02086,"Across all three behaviors, stage of change, effort, and severity effects were consistently related to behavior change at 24 months.","[{'ForeName': 'Miryam', 'Initials': 'M', 'LastName': 'Yusufov', 'Affiliation': 'Cancer Prevention Research Center and the Department of Psychology, University of Rhode Island, RI, USA miryam_yusufov@my.uri.edu.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Prochaska', 'Affiliation': 'Cancer Prevention Research Center and the Department of Psychology, University of Rhode Island, RI, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Paiva', 'Affiliation': 'Cancer Prevention Research Center and the Department of Psychology, University of Rhode Island, RI, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Rossi', 'Affiliation': 'Cancer Prevention Research Center and the Department of Psychology, University of Rhode Island, RI, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Blissmer', 'Affiliation': 'Cancer Prevention Research Center and the Department of Kinesiology, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Redding', 'Affiliation': 'Cancer Prevention Research Center and the Department of Psychology, University of Rhode Island, RI, USA.'}, {'ForeName': 'Wayne F', 'Initials': 'WF', 'LastName': 'Velicer', 'Affiliation': 'Cancer Prevention Research Center and the Department of Psychology, University of Rhode Island, RI, USA Cancer Prevention Research Center and the Department of Kinesiology, University of Rhode Island, Kingston, RI, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117116646341']
1896,32416072,"Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND
Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahepatic cholangiocarcinoma, a relatively uncommon cancer with a poor clinical outcome. The aim of this international phase 3 study was to assess the efficacy and safety of ivosidenib (AG-120)-a small-molecule targeted inhibitor of mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma.
METHODS
This multicentre, randomised, double-blind, placebo-controlled, phase 3 study included patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (2:1) with a block size of 6 and stratified by number of previous systemic treatment regimens for advanced disease to oral ivosidenib 500 mg or matched placebo once daily in continuous 28-day cycles, by means of an interactive web-based response system. Placebo to ivosidenib crossover was permitted on radiological progression per investigator assessment. The primary endpoint was progression-free survival by independent central review. The intention-to-treat population was used for the primary efficacy analyses. Safety was assessed in all patients who had received at least one dose of ivosidenib or placebo. Enrolment is complete; this study is registered with ClinicalTrials.gov, NCT02989857.
FINDINGS
Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients were randomly assigned to ivosidenib (n=124) or placebo (n=61). Median follow-up for progression-free survival was 6·9 months (IQR 2·8-10·9). Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001). The most common grade 3 or worse adverse event in both treatment groups was ascites (four [7%] of 59 patients receiving placebo and nine [7%] of 121 patients receiving ivosidenib). Serious adverse events were reported in 36 (30%) of 121 patients receiving ivosidenib and 13 (22%) of 59 patients receiving placebo. There were no treatment-related deaths.
INTERPRETATION
Progression-free survival was significantly improved with ivosidenib compared with placebo, and ivosidenib was well tolerated. This study shows the clinical benefit of targeting IDH1 mutations in advanced, IDH1-mutant cholangiocarcinoma.
FUNDING
Agios Pharmaceuticals.",2020,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"['mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma', 'patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1', 'Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients']","['Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy', 'ivosidenib or placebo', 'Placebo', 'oral ivosidenib 500 mg or matched placebo', 'ivosidenib', 'ivosidenib (AG-120)-a small-molecule targeted inhibitor', 'placebo']","['Safety', 'tolerated', 'progression-free survival', 'Median follow-up for progression-free survival', 'adverse event', 'efficacy and safety', 'Progression-free survival', 'Serious adverse events']","[{'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C4682397', 'cui_str': 'ivosidenib'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3827169', 'cui_str': 'AG-120'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",230.0,0.76452,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"[{'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Medical College at Cornell University, New York, NY, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Milind M', 'Initials': 'MM', 'LastName': 'Javle', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lubner', 'Affiliation': 'Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Adeva', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Department of Hematology-Oncology, Mayo Clinic Cancer Center, Phoenix, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Medical Oncology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Harris', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Murphy', 'Affiliation': 'Department of Oncology-Gastrointestinal Cancer, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Whisenant', 'Affiliation': 'Medical Oncology and Hematology, Utah Cancer Specialists, Salt Lake City, UT, USA.'}, {'ForeName': 'Maeve A', 'Initials': 'MA', 'LastName': 'Lowery', 'Affiliation': 'Trinity St James Cancer Institute, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachna T', 'Initials': 'RT', 'LastName': 'Shroff', 'Affiliation': 'Department of Medicine, University of Arizona Cancer Center, Tucson, AZ, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christina X', 'Initials': 'CX', 'LastName': 'Chamberlain', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Liewen', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Gliser', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Shuchi S', 'Initials': 'SS', 'LastName': 'Pandya', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, UK; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA; Jiahui International Cancer Center, Jiahui Health, Shanghai, China. Electronic address: azhu@mgh.harvard.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30157-1']
1897,32492705,Moderate-intensity exercise and high-intensity interval training affect insulin sensitivity similarly in obese adults.,"OBJECTIVE
We compared the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on insulin sensitivity and other important metabolic adaptations in adults with obesity.
METHODS
Thirty-one inactive adults with obesity (age: 31±6 years, BMI: 33±3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10x1-minute at 90%HRmax, 1-minute active recovery; n=16) or MICT (45 minutes at 70%HRmax; n=15). To assess the direct effects of exercise independent of weight/fat loss, participants were required to maintain body mass.
RESULTS
Training increased peak oxygen uptake by ~10% in both HIIT and MICT (p<0.0001), and body weight/fat mass were unchanged. Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp) was ~20% greater the day after the final exercise session compared to Pre-Training (p<0.01), with no difference between HIIT and MICT. When trained participants abstained from exercise for 4 days, insulin sensitivity returned to Pre-Training levels in both groups. HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism. Training-induced alterations in muscle lipid profile were also similar between groups.
CONCLUSION
Despite large differences in training intensity and exercise time, 12 weeks of HIIT and MICT induce similar acute improvements in peripheral insulin sensitivity the day after exercise, and similar longer-term metabolic adaptations in skeletal muscle in adults with obesity. These findings support the notion that the insulin-sensitizing effects of both HIIT and MICT are mediated by factors stemming from the most recent exercise session(s) rather than adaptations that accrue with training.",2020,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"['adults with obesity', 'obese adults', 'Thirty-one inactive adults with obesity (age: 31±6 years, BMI: 33±3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10x1-minute at 90%HRmax, 1-minute active recovery; n=16) or']","['MICT', 'high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT', 'HIIT and MICT', 'Moderate-intensity exercise and high-intensity interval training']","['muscle lipid profile', 'peak oxygen uptake', 'insulin sensitivity', 'Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp', 'body weight/fat mass']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",31.0,0.0721815,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Schleh', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Cheehoon', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Ludzki', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Gillen', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Varshney', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Van Pelt', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Chenevert', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Gioscia-Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Suzette M', 'Initials': 'SM', 'LastName': 'Howton', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rode', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Burant', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Horowitz', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa345']
1898,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND
Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity.
METHODS
Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy.
FINDINGS
152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases.
INTERPRETATION
Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039']
1899,31610936,Predictors and Outcomes of Early Intubation in Infants Born at 28-36 Weeks of Gestation Receiving Noninvasive Respiratory Support.,"OBJECTIVE
To identify predictors and outcomes of early intubation in preterm infants with respiratory distress, and predictors of need for brief respiratory support (≤1 day).
STUDY DESIGN
Secondary analysis of data from a randomized trial comparing nasal high-flow with continuous positive airway pressure as primary respiratory support in preterm infants born at 28-36 weeks of gestation. Intubation was assessed within 72 hours of randomization.
RESULTS
There were 564 included infants with a mean (SD) gestational age of 32.0 (2.2) weeks and birth weight 1744 (589) g; 76 infants (13.5%) received early intubation. On multivariable analysis, lower gestational age and higher pre-randomization fraction of inspired oxygen (FiO 2 ) predicted intubation. A test based on gestational age of <30 weeks and an FiO 2 of ≥0.30 produced a likelihood ratio of 9.1. Intubation was associated with prolonged duration of respiratory support and supplemental oxygen, with pneumothorax and nasal trauma, and in infants born at <32 weeks of gestational, with bronchopulmonary dysplasia and patent ductus arteriosus requiring treatment. Greater gestational age and lower FiO 2 predicted the need for ≤1 day of respiratory support. A test based on a gestational age of ≥34 weeks and an FiO 2 of 0.21 produced a likelihood ratio of 4.7.
CONCLUSIONS
In preterm infants 28-36 week of gestation receiving primary noninvasive respiratory support, lower gestational age, and higher FiO 2 predicted need for intubation within 72 hours. Intubation was associated with adverse respiratory outcomes. Greater gestational age and lower FiO 2 predicted need for ≤1 day of respiratory support. It may be reasonable to defer the use of respiratory support in more mature infants with low FiO 2 requirements. TRIAL REGISTRATION AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY: ACTRN12613000303741.",2020,"Intubation was associated with prolonged duration of respiratory support and supplemental oxygen, with pneumothorax and nasal trauma, and in infants born at <32 weeks of gestational, with bronchopulmonary dysplasia and patent ductus arteriosus requiring treatment.","['infants born at <32\xa0weeks of gestational, with bronchopulmonary dysplasia and patent ductus arteriosus requiring treatment', 'Infants Born at 28-36\xa0Weeks of Gestation Receiving Noninvasive Respiratory Support', '564 included infants with a mean (SD) gestational age of 32.0 (2.2) weeks and birth weight 1744 (589) g; 76 infants (13.5%) received early intubation', 'preterm infants born at 28-36\xa0weeks of gestation', 'preterm infants with respiratory distress, and predictors of need for brief respiratory support (≤1\xa0day', 'preterm infants 28-36\xa0week of gestation receiving primary noninvasive respiratory support, lower gestational age, and higher FiO 2 predicted need for intubation within 72\xa0hours']",['nasal high-flow with continuous positive airway pressure'],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]",[],,0.211618,"Intubation was associated with prolonged duration of respiratory support and supplemental oxygen, with pneumothorax and nasal trauma, and in infants born at <32 weeks of gestational, with bronchopulmonary dysplasia and patent ductus arteriosus requiring treatment.","[{'ForeName': 'Calum T', 'Initials': 'CT', 'LastName': 'Roberts', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, Victoria, Australia; Department of Pediatrics, Monash University, Melbourne, Victoria, Australia; Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia. Electronic address: calum.roberts@monash.edu.""}, {'ForeName': 'Louise S', 'Initials': 'LS', 'LastName': 'Owen', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Dag H', 'Initials': 'DH', 'LastName': 'Frøisland', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Pediatrics, Innlandet Hospital Trust, Lillehammer, Norway.""}, {'ForeName': 'Lex W', 'Initials': 'LW', 'LastName': 'Doyle', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Pediatrics, The University of Melbourne, Melbourne, Australia.""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Manley', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.09.026']
1900,32492157,Young adult outcomes of childhood prophylaxis for severe hemophilia A: results of the Joint Outcome Continuation Study.,"The Joint Outcome Study (JOS), a randomized controlled trial, demonstrated that children with severe hemophilia A (HA) initiating prophylactic factor VIII (FVIII) prior to age 2.5 years had reduced joint damage at age 6 years compared with those treated with episodic FVIII for bleeding. The Joint Outcome Continuation Study (JOS-C) evaluated early vs delayed prophylaxis effects on long-term joint health, following JOS participants to age 18 years in an observational, partially retrospective study. Index joint magnetic resonance imaging (MRI) scores of osteochondral (OC) damage (primary outcome), joint physical examination scores, and annualized rates of joint/other bleeding episodes (secondary outcomes) were collected. Thirty-seven of 65 JOS participants enrolled in JOS-C, including 15 randomized to prophylaxis at mean age 1.3 years (""early prophylaxis""); 18 initially randomized to episodic treatment, starting ""delayed prophylaxis"" at mean age 7.5 years; and 4 with high-titer inhibitors. At JOS-C exit, MRI OC damage was found in 77% of those on delayed and 35% of those on early prophylaxis for an odds ratio of OC damage, in the delayed vs early prophylaxis group, of 6.3 (95% confidence interval, 1.3, 29.9; P = .02). Annualized bleeding rates were higher with delayed prophylaxis (mean plus or minus standard deviation, 10.6 ± 6.6 vs 3.5 ± 2.1; P < .001), including when only comparing time periods on prophylaxis (6.2 ± 5.3 vs 3.3 ± 1.9; P < .05). In severe HA, early initiation of prophylaxis provided continued protection against joint damage throughout childhood compared with delayed initiation, but early prophylaxis was not sufficient to fully prevent damage. This trial was registered at www.clinicaltrials.gov as #NCT01000844.",2020,"At JOS-C exit, MRI OC damage was found in 77% of those on delayed and 35% of those on early prophylaxis for an odds ratio of OC damage, in the delayed vs early prophylaxis group, of 6.3 (95% confidence interval, 1.3, 29.9; P = .02).","['JOS participants to age 18 years in an observational, partially retrospective study', 'severe hemophilia A', 'Thirty-seven of 65 JOS participants enrolled in JOS-C, including 15 randomized to prophylaxis at mean age 1.3 years (""early prophylaxis""); 18 initially randomized to episodic treatment, starting ""delayed prophylaxis"" at mean age 7.5 years; and 4 with high-titer inhibitors', 'children with severe hemophilia A (HA) initiating prophylactic factor VIII (FVIII) prior to age 2.5 years had reduced joint damage at age 6 years compared with those treated with episodic FVIII for bleeding']",['childhood prophylaxis'],"['Index joint magnetic resonance imaging (MRI) scores of osteochondral (OC) damage (primary outcome), joint physical examination scores, and annualized rates of joint/other bleeding episodes (secondary outcomes', 'MRI OC damage', 'Annualized bleeding rates']","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0444497', 'cui_str': 'In joint'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0476169', 'cui_str': 'Osteochondral fracture'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",18.0,0.141139,"At JOS-C exit, MRI OC damage was found in 77% of those on delayed and 35% of those on early prophylaxis for an odds ratio of OC damage, in the delayed vs early prophylaxis group, of 6.3 (95% confidence interval, 1.3, 29.9; P = .02).","[{'ForeName': 'Beth Boulden', 'Initials': 'BB', 'LastName': 'Warren', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Thornhill', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': ""Section of Pediatric Radiology, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fadell', 'Affiliation': ""Section of Pediatric Radiology, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Ingram', 'Affiliation': ""Section of Pediatric Radiology, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Funk', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Norton', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Heidi D', 'Initials': 'HD', 'LastName': 'Lane', 'Affiliation': ""Primary Children's Hospital, Salt Lake City, UT.""}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Bennett', 'Affiliation': 'Department of Pediatrics, School of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Dunn', 'Affiliation': 'Department of Pediatrics, School of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Recht', 'Affiliation': 'Division of Hematology and Oncology, Department of Pediatrics, Oregon Health & Science University, Portland, OR; and.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shapiro', 'Affiliation': 'Indiana Hemophilia and Thrombosis Center, Indianapolis, IN.'}, {'ForeName': 'Marilyn J', 'Initials': 'MJ', 'LastName': 'Manco-Johnson', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO.'}]",Blood advances,['10.1182/bloodadvances.2019001311']
1901,27547026,Harmonic Scalpel versus Monopolar Electrocauterization in Cholecystectomy.,"BACKGROUND AND OBJECTIVES
Laparoscopic cholecystectomy (LC) using surgical electrocautery is considered to be the gold standard procedure for the treatment of uncomplicated cholecystitis and cholelithiasis. The objective of the current study was to evaluate the effectiveness and safety of the Harmonic scalpel, an advanced laparoscopic technique associated with less thermal damage in LC, when compared to electrocautery.
METHODS
From October 2010 through June 2013, a total of 198 patients were randomly allocated to LC with a Harmonic scalpel (experimental group, 117 patients) or conventional monopolar electrocautery (control group, 81 patients). The main outcome measures were operative time, blood loss, conversion to laparotomy, postoperative hospital stay, post-LC pain, and cost effectiveness.
RESULTS
The 2 groups were comparable with respect to baseline patient characteristics. When compared to conventional monopolar electrocautery, there were no significant reductions in the operative time, bleeding, frequency of conversion to laparotomy, and duration of postoperative recovery with the Harmonic scalpel (P > .05 for all).
CONCLUSIONS
Laparoscopic cholecystectomy using conventional monopolar electrocautery is as effective and safe as that with the Harmonic scalpel, for treating uncomplicated cholecystitis and cholelithiasis.",2016,"When compared to conventional monopolar electrocautery, there were no significant reductions in the operative time, bleeding, frequency of conversion to laparotomy, and duration of postoperative recovery with the Harmonic scalpel (P > .05 for all).
","['From October 2010 through June 2013, a total of 198 patients']","['LC with a Harmonic scalpel', 'Laparoscopic cholecystectomy using conventional monopolar electrocautery', 'Laparoscopic cholecystectomy (LC', 'Harmonic Scalpel versus Monopolar Electrocauterization', 'Harmonic scalpel', 'conventional monopolar electrocautery']","['operative time, bleeding, frequency of conversion to laparotomy, and duration of postoperative recovery', 'operative time, blood loss, conversion to laparotomy, postoperative hospital stay, post-LC pain, and cost effectiveness', 'effectiveness and safety']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",198.0,0.028081,"When compared to conventional monopolar electrocautery, there were no significant reductions in the operative time, bleeding, frequency of conversion to laparotomy, and duration of postoperative recovery with the Harmonic scalpel (P > .05 for all).
","[{'ForeName': 'Guanqun', 'Initials': 'G', 'LastName': 'Liao', 'Affiliation': 'Department of General Surgery, Foshan Municipal Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Shunqian', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of General Surgery, Foshan Municipal Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Xueyi', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of General Surgery, Foshan Municipal Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, Foshan Municipal Hospital, Southern Medical University, Foshan, China.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2016.00037']
1902,32492354,Rationale and Design of ORCHID: A Randomized Placebo-Controlled Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19.,"The Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with COVID-19. This document provides the rationale and background for the trial and highlights key design features. We discuss five novel challenges to the design and conduct of a large, multi-center, randomized trial during a pandemic, including: 1) widespread, off-label use of the study drug before the availability of safety and efficacy data; 2) the need to adapt traditional procedures for documentation of informed consent during an infectious pandemic; 3) developing a flexible and robust Bayesian analysis incorporating significant uncertainty about the disease, outcomes, and treatment; 4) obtaining indistinguishable drug and placebo without delaying enrollment; and 5) rapidly obtaining administrative and regulatory approvals. Our goals in describing how the ORCHID trial progressed from study conception to enrollment of the first patient in 15 days are to inform the development of other high-quality, multi-center trials targeting COVID-19. We describe lessons learned to improve the efficiency of future clinical trials, particularly in the setting of pandemics. The ORCHID trial will provide high-quality, clinically relevant data on the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults. This trial was registered with ClinicalTrials.gov (NCT04332991) prior to enrollment of the first patient on April 2, 2020.",2020,"The Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with COVID-19.","['patients with symptomatic Disease (ORCHID) trial', 'hospitalized adults', 'adults hospitalized with COVID-19', 'Adults Hospitalized with COVID-19']","['Placebo', 'ORCHID', 'hydroxychloroquine', 'Hydroxychloroquine', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.277733,"The Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with COVID-19.","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Vanderbilt University Medical Center, Division of Allergy, Pulmonary, and Critical Care, Nashville, Tennessee, United States; jonathan.d.casey@vumc.org.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Johnson', 'Affiliation': 'University of Washington/Harborview Medical Center, Emergency Medicine, Seattle, Washington, United States.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Vanderbilt University, Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Nashville, Tennessee, United States.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Vanderbilt University Medical Center, Emergency Medicine, Nashville, Tennessee, United States.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Aggarwal', 'Affiliation': 'NHLBI, 35035, Division of Lung Diseases, Bethesda, Maryland, United States.'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'School of Medicine, Johns Hopkins University, Pulmonary and Critical Care, Baltimore, Maryland, United States.'}, {'ForeName': 'Steven Y', 'Initials': 'SY', 'LastName': 'Chang', 'Affiliation': 'David Geffen School of Medicine at UCLA, Medicine (Pulmonary & Critical Care), Los Angeles, California, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eppensteiner', 'Affiliation': 'Duke University School of Medicine, 12277, Department of Surgery, Durham, North Carolina, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Filbin', 'Affiliation': 'Massachusetts General Hospital, 2348, Emergency Medicine, Boston, Massachusetts, United States.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Wake Forest University School of Medicine, 12279, Pulmonary, Critical Care, Allergy, and Immunologic Disease, Winston Salem, North Carolina, United States.'}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'University of Colorado School of Medicine, Department of Emergency Medicine, Aurora, Colorado, United States.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': 'Montefiore Medical Center, 12Division of Epidemiology and Population Health, Department of Medicine, Bronx, New York, United States.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Harrell', 'Affiliation': 'Vanderbilt University Medical Center, Biostatistics, Nashville, Tennessee, United States.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Hayden', 'Affiliation': 'Massachusetts General Hospital, 2348, Medicine, Boston, Massachusetts, United States.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'University of Washington/Harborview Medical Center, Division of Pulmonary, Critical Care, and Sleep Medicine, Seattle, Washington, United States.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Oregon Health and Science University, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Portland, Oregon, United States.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Leither', 'Affiliation': 'Intermountain Medical Center, 98078, Division of Pulmonary and Critical Care Medicine, Murray, Utah, United States.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'University of Colorado School of Medicine, Division of Pulmonary Sciences and Critical Care Medicine, Aurora, Colorado, United States.'}, {'ForeName': 'Cathryn F', 'Initials': 'CF', 'LastName': 'Oldmixon', 'Affiliation': 'Massachusetts General Hospital, 2348, Medicine, Boston, Massachusetts, United States.'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'University of Michigan, Surgery, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Lora A', 'Initials': 'LA', 'LastName': 'Reineck', 'Affiliation': 'NHLBI, 35035, Division of Lung Diseases, Bethesda, Maryland, United States.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Ringwood', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, United States.'}, {'ForeName': 'Bryce Rh', 'Initials': 'BR', 'LastName': 'Robinson', 'Affiliation': 'University of Washington, Surgery, Seattle, Washington, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Massachusetts General Hospital, 2348, Medicine, Boston, Massachusetts, United States.'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'Beth Israel Deaconess Medical Center, Emergency Medicine, Boston, Massachusetts, United States.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Steingrub', 'Affiliation': 'Baystate Medical Center, Division of Pulmonary and Critical Care, Springfield, Massachusetts, United States.'}, {'ForeName': 'Donna K', 'Initials': 'DK', 'LastName': 'Torr', 'Affiliation': 'Vanderbilt University Medical Center, Department of Pharmacy Services, Nashville, Tennessee, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weissman', 'Affiliation': 'University of Pittsburgh, 6614, Emergency Medicine, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Vanderbilt University, Biostatistics, Nashville, Tennessee, United States.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Vanderbilt University Medical Center, 12328, Department of Allergy, Pulmonary, and Critical Care Medicine, Nashville, Tennessee, United States.'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'Massachusetts General Hospital, Harvard School of Medicine,, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Boston, Massachusetts, United States.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': 'Intermountain Medical Center, Division of Pulmonary and Critical Care Medicine, Murray, Utah, United States.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Vanderbilt University Medical Center, 12328, Emergency Medicine, Nashville, Tennessee, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202005-478SD']
1903,32492600,Cross-fading motives for simultaneous alcohol and marijuana use: Associations with young adults' use and consequences across days.,"BACKGROUND
Many young adults engage in simultaneous alcohol and marijuana (SAM) use so that their effects overlap. Little is known about motivations for dual substance use and associations with use and consequences. This study examined daily-level associations between cross-fading motives and levels of alcohol and marijuana use and consequences.
METHODS
Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts. Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women). Multilevel models assessed between- and within-person effects of cross-fading motives (i.e., to enhance the effects of marijuana and/or alcohol use by using them simultaneously) on alcohol and marijuana use and consequences, after adjusting for general enhancement, social, coping, and conformity motives and the amount of alcohol and marijuana used that day.
RESULTS
On 76 % of SAM use days, participants endorsed cross-fading motives (i.e., to enhance the effect of alcohol or marijuana or to get drunk and high at the same time). Having stronger cross-fading motives was associated with greater alcohol use, perceived intoxication, and positive alcohol consequences at the between- and within-person levels. In addition, between-person, individuals who reported stronger cross-fading motives on average reported more negative alcohol consequences and positive marijuana consequences on average. Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day.
CONCLUSIONS
Cross-fading motives were common and varied from day to day. Understanding the motivational context for dual substance use may support future interventions for cross-fading.",2020,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day.
","['Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women', 'Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts']",[],['negative alcohol consequences and positive marijuana consequences'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C4517627', 'cui_str': '2.16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]",1049.0,0.0152649,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day.
","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health and Institute of Child Development, University of Minnesota, 1100 Washington Ave S., Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fairlie', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108077']
1904,32492882,Low Expression of miR-20a-5p Predicts Benefit to Bevacizumab in Metastatic Breast Cancer Patients Treated within the TANIA Phase III Trial.,"BACKGROUND
In metastatic breast cancer (MBC) patients, no biomarker predicting benefit to a bevacizumab-containing therapy has been established yet. MicroRNAs (miRNAs) are involved in angiogenesis and treatment resistance and therefore could be of predictive value.
METHODS
Profiling of 754 miRNAs was performed in tumor samples of 58 MBC patients treated with a bevacizumab-containing first-line regimen (learning set). Based on progression-free survival (PFS), patients were divided into responders (R) and non-responders (NR). Differentially expressed miRNAs between R and NR were analyzed in a cohort of 57 patients treated with first-line chemotherapy without bevacizumab (control set), to exclude miRNAs providing prognostic information. MiRNA candidates significantly associated with PFS in multivariate analysis were further validated in tumor samples of 203 patients treated within the phase III trial TANIA randomizing between chemotherapy either alone or with bevacizumab after progression on first-line bevacizumab.
RESULTS
Low expression of miR-20a-5p (multivariate p = 0.035) and miR-21-5p (multivariate p = 0.004) were significantly associated with longer PFS in the learning set, but not in the control set. In samples from the TANIA trial, low expression of miR-20a-5p was also significantly associated with longer PFS (hazard ration (HR) 0.60; 95%-CI 0.37-0.89; p = 0.012) and longer overall survival (OS; HR 0.54; 95%-CI 0.32-0.83; p = 0.007) in the bevacizumab arm but not in the chemotherapy-only arm (PFS: HR 0.73, p = 0.119; OS: HR 1.01; p = 0.964). For miR-21-5p no significant association with PFS or OS in both treatment arms was observed.
CONCLUSION
MiR-20a-5p expression in breast cancer tissue was predictive for a greater benefit from bevacizumab-containing therapy in two independent cohorts.",2020,"RESULTS
Low expression of miR-20a-5p (multivariate p = 0.035) and miR-21-5p (multivariate p = 0.004) were significantly associated with longer PFS in the learning set, but not in the control set.","['Metastatic Breast Cancer Patients', 'metastatic breast cancer (MBC) patients', 'Profiling of 754 miRNAs was performed in tumor samples of 58 MBC patients treated with a']","['bevacizumab-containing first-line regimen (learning set', 'bevacizumab-containing therapy', 'bevacizumab', 'Bevacizumab']","['progression-free survival (PFS', 'PFS or OS', 'overall survival']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.032456,"RESULTS
Low expression of miR-20a-5p (multivariate p = 0.035) and miR-21-5p (multivariate p = 0.004) were significantly associated with longer PFS in the learning set, but not in the control set.","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rinnerthaler', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Simon Peter', 'Initials': 'SP', 'LastName': 'Gampenrieder', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Hackl', 'Affiliation': 'Institute of Bioinformatics, Biocenter, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Steiner', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Monzo-Fuentes', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Melchardt', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Magnes', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Huemer', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Westphal', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Hufnagl', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Hauser-Kronberger', 'Affiliation': 'Department of Pathology, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Egle', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Department of Internal Medicine III with Haematology, Salzburg Cancer Research Institute, Oncologic Center Salzburg, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9061663']
1905,31326117,Visual Acuity Assessment and Vision Screening Using a Novel Smartphone Application.,"OBJECTIVES
To evaluate a smartphone-based application's (Peek Acuity) ability to assess visual acuity and screen for ocular conditions in children, we compared visual acuity assessment between Peek Acuity and the pediatric ophthalmology examination and evaluated Peek Acuity's ability to identify children with referable ocular conditions.
STUDY DESIGN
We prospectively recruited 111 children age 3-17 years, presenting to a pediatric ophthalmology clinic, who could follow instructions. Monocular visual acuity assessments by Peek Acuity and standard clinical methods were performed in randomized order. We compared visual acuity assessments between methods using intraclass correlation coefficient (ICC) and evaluated Peek Acuity's ability to identify children with referable ocular conditions.
RESULTS
ICC comparing visual acuity assessed between methods was 0.88 (95% CI 0.83-0.92) for first and 0.85 (95% CI 0.78-0.89) for second eyes examined. ICC among 3 to 5-year-olds (preschool-age children) was 0.88 (95% CI 0.77-0.94) for first and 0.45 (95% CI 0.13-0.68) for second eyes examined. Peek Acuity had a sensitivity of 83%-86% for decreased vision and 69%-83% for referable ocular disease. Sensitivity was highest among 3 to 5-year-olds with decreased vision, 93%-100%.
CONCLUSIONS
Overall, Peek Acuity visual acuity assessment correlated well with visual acuity assessed by standard clinical methods, though preschool-age children appeared more susceptible to examination fatigue. Peek Acuity performed adequately as a screening tool and had the greatest sensitivity among those with decreased vision and preschool-age children.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03212222.",2019,Peek Acuity had a sensitivity of 83%-86% for decreased vision and 69%-83% for referable ocular disease.,"['111 children age 3-17\xa0years, presenting to a pediatric ophthalmology clinic, who could follow instructions', 'children with referable ocular conditions']","[""smartphone-based application's (Peek Acuity""]","['Sensitivity', 'Visual Acuity Assessment and Vision Screening', 'visual acuity', 'Monocular visual acuity assessments', 'Overall, Peek Acuity visual acuity assessment', 'visual acuity assessments']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1628978', 'cui_str': 'Pediatric ophthalmology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0042792', 'cui_str': 'Vision Screening'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}]",111.0,0.287758,Peek Acuity had a sensitivity of 83%-86% for decreased vision and 69%-83% for referable ocular disease.,"[{'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Sandra S', 'Initials': 'SS', 'LastName': 'Stinnett', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, NC; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'S Grace', 'Initials': 'SG', 'LastName': 'Prakalapakorn', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, NC; Department of Pediatrics, Duke University, Durham, NC. Electronic address: grace.prakalapakorn@duke.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.06.021']
1906,32416434,The immediate effects of a shoulder brace on muscle activity and scapular kinematics in subjects with shoulder impingement syndrome and rounded shoulder posture: A randomized crossover design.,"BACKGROUND
Round shoulder posture (RSP) is one of the potential risks for shoulder impingement syndrome (SIS) due to alignment deviation of the scapula. Evidence on how the characteristics of a shoulder brace affecting the degree of RSP, shoulder kinematics, and associated muscle activity during movements is limited.
RESEARCH QUESTION
The purposes of this study were (1) to compare the effects of a shoulder brace on clinical RSP measurements, muscle activities and scapular kinematics during arm movements in subjects with shoulder impingement syndrome (SIS) and RSP; and (2) to compare the effects of two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps on muscle activities and scapular kinematics during arm movements in subjects with SIS and RSP.
METHODS
Twenty-four participants (12 males; 12 females) with SIS and RSP were randomly assigned into 2 groups (comfortable then forced, and forced then comfortable) with 2 strap configurations in each tension condition. The pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA) were used to assess the degree of RSP. Three-dimensional electromagnetic motion analysis and electromyography were used to record the scapular kinematics and muscle activity during arm movements.
RESULTS
All clinical measurements with the brace were significantly improved (p < 0.05). Under forced tension, muscle activities were higher with the diagonal configuration than with the parallel configuration in the lower trapezius (LT) (1.2-2.3% MVIC, p < 0.05) and serratus anterior (SA) (2.3% MVIC, p = 0.015). For upward rotation and posterior tilting of the scapula, the diagonal configuration was larger than the parallel configuration (1.5°, p = 0.038; 0.4°-0.5°, p < 0.05, respectively).
SIGNIFICANCE
Different characteristics of the straps of the shoulder brace could alter muscle activity and scapular kinematics at different angles during arm movement. Based on the clinical treatment preference, the application of a shoulder brace with a diagonal configuration and forced tension is suggested for SIS and RSP subjects.",2020,All clinical measurements with the brace were significantly improved (p < 0.05).,"['subjects with SIS and RSP.\nMETHODS\n\n\nTwenty-four participants (12 males; 12 females) with SIS and RSP', 'subjects with shoulder impingement syndrome (SIS) and RSP; and (2', 'subjects with shoulder impingement syndrome and rounded shoulder posture']","['Round shoulder posture (RSP', 'shoulder brace', 'two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps']","['pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA', 'Under forced tension, muscle activities', 'muscle activity and scapular kinematics', 'clinical RSP measurements, muscle activities and scapular kinematics', 'serratus anterior (SA) ']","[{'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0443198', 'cui_str': 'Diagonal'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0183631', 'cui_str': 'Strap'}]","[{'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C2717795', 'cui_str': 'Clinical Rounds'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0621097,All clinical measurements with the brace were significantly improved (p < 0.05).,"[{'ForeName': 'Yuan-Chun', 'Initials': 'YC', 'LastName': 'Chiu', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Yung-Shen', 'Initials': 'YS', 'LastName': 'Tsai', 'Affiliation': 'Department of Sports Sciences and Institute of Sports Equipment Technology, University of Taipei, Taiwan.'}, {'ForeName': 'Chien-Lung', 'Initials': 'CL', 'LastName': 'Shen', 'Affiliation': 'Department of Products, Taiwan Textile Research Institute, Taiwan.'}, {'ForeName': 'Tyng-Guey', 'Initials': 'TG', 'LastName': 'Wang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Jing-Lan', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: yangjinglan@gmail.com.'}, {'ForeName': 'Jiu-Jenq', 'Initials': 'JJ', 'LastName': 'Lin', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan; Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: jiujlin@ntu.edu.tw.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.028']
1907,26916879,The Impact of Smoking Very Low Nicotine Content Cigarettes on Alcohol Use.,"BACKGROUND
Reducing the nicotine content in cigarettes could improve public health by reducing smoking and toxicant exposure, but may also have unintended consequences on alcohol use. The primary objective of this study was to examine the effect of reducing the nicotine content in cigarettes on alcohol outcomes. The secondary aim was to examine whether the effects of these cigarettes on alcohol outcomes were mediated by changes in nicotine exposure, smoking behavior, or withdrawal.
METHODS
Between June 2013 and July 2014, we conducted a 7-arm, double-blind, randomized clinical trial at 10 U.S.-based sites. Daily smokers not currently interested in quitting (n = 839) were assigned to equally sized groups to smoke for 6 weeks cigarettes containing either normal nicotine content (NNC; 15.8 mg/g, 9 mg tar), moderate nicotine content (5.2 mg/g nicotine, 9 mg tar), or very low nicotine content (VLNC; 0.4 to 2.4 mg/g, 9 to 13 mg tar). This investigation focused on a subsample of current drinkers (n = 403). Each reduced nicotine content cigarette condition was compared to the NNC control condition with respect to trajectories over the 6-week period of average daily alcohol use and occurrence of binge drinking. Moderating variables were considered. Mediation analyses tested potential explanatory processes including changes in nicotine exposure, cigarettes per day, and withdrawal.
RESULTS
Over time, reduced nicotine exposure and smoking rate mediated effects of VLNC cigarette use on reduced alcohol use. There was no evidence of compensatory drinking in response to nicotine reduction or nicotine withdrawal, even among subgroups expected to be at greater risk (e.g., relatively heavier drinkers, highly nicotine-dependent individuals).
CONCLUSIONS
The findings suggest that compensatory drinking is unlikely to occur in response to switching to VLNC cigarettes. In contrast, reducing the nicotine content of cigarettes may reduce alcohol use (clinicalTrials.gov number, NCT01681875).",2016,"There was no evidence of compensatory drinking in response to nicotine reduction or nicotine withdrawal, even among subgroups expected to be at greater risk (e.g., relatively heavier drinkers, highly nicotine-dependent individuals).
","['subsample of current drinkers (n\xa0=\xa0403', 'Daily smokers not currently interested in quitting (n\xa0=\xa0839', 'Between June 2013 and July 2014']","['normal nicotine content (NNC; 15.8\xa0mg/g, 9\xa0mg tar), moderate nicotine content (5.2\xa0mg/g nicotine, 9\xa0mg tar), or very low nicotine content (VLNC', 'Smoking Very Low Nicotine Content Cigarettes']","['nicotine exposure, smoking behavior, or withdrawal', 'nicotine exposure, cigarettes per day, and withdrawal']","[{'cui': 'C0556297', 'cui_str': 'Current drinker of alcohol (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0651569', 'cui_str': ""9-(1'-hydroxy-2'-(hydroxymethyl)ethoxy)methylguanine""}, {'cui': 'C3887664', 'cui_str': 'Tars, topical antipsoriatics'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}]",839.0,0.0138265,"There was no evidence of compensatory drinking in response to nicotine reduction or nicotine withdrawal, even among subgroups expected to be at greater risk (e.g., relatively heavier drinkers, highly nicotine-dependent individuals).
","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Dermody', 'Affiliation': 'Department of Psychology , University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies , Brown University, Providence, Rhode Island.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger', 'Affiliation': 'Center for Alcohol and Addiction Studies , Brown University, Providence, Rhode Island.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""al'Absi"", 'Affiliation': 'University of Minnesota Medical School , Duluth, Minnesota.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Department of Health Outcomes and Behavior , Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry , University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Psychology , University of Pittsburgh, Pittsburgh, Pennsylvania.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.12980']
1908,31511436,Efficacy and Safety of Uninterrupted Periprocedural Edoxaban in Patients Undergoing Catheter Ablation for Atrial Fibrillation - The Prospective KYU-RABLE Study.,"BACKGROUND
The KYU-RABLE study, a prospective, multicenter, single-arm interventional study, evaluated the efficacy and safety of uninterrupted oral edoxaban in patients undergoing catheter ablation (CA) for atrial fibrillation (AF).Methods and Results:We enrolled patients with AF from 23 centers in Japan. Edoxaban 60 mg (30 mg in patients indicated for dose adjustment) was administered uninterrupted, once daily in the morning for ≥4 weeks before CA and 4 weeks ±7 days after CA with one dose delayed on the procedural day. The primary endpoint was a composite of thromboembolism and major bleeding during 4 weeks from the procedural day. Among the 513 eligible patients who underwent CA, 63.5% received edoxaban 60 mg/day and 36.1% received 30 mg/day. For the primary endpoint, no thromboembolism and 1 major bleeding event (0.2%, cardiac tamponade) were observed. The plasma edoxaban concentration decreased depending on the time from the last administration to the CA procedure. However, plasma levels of coagulative biomarkers were within appropriate ranges regardless of the interval from the last administration of edoxaban.
CONCLUSIONS
The present study provided evidence of the efficacy and safety of uninterrupted edoxaban administered once daily in the morning, with one dose delayed on procedural day, in patients with AF undergoing CA. Edoxaban was associated with a low risk of periprocedural thromboembolic and bleeding complications.",2019,"For the primary endpoint, no thromboembolism and 1 major bleeding event (0.2%, cardiac tamponade) were observed.","['patients undergoing catheter ablation (CA) for atrial fibrillation (AF).Methods\u2004and\u2004Results:We enrolled patients with AF from 23 centers in Japan', '513 eligible patients who underwent CA, 63.5% received', 'Patients Undergoing Catheter Ablation for Atrial Fibrillation\u3000', 'patients with AF undergoing CA']","['edoxaban', 'uninterrupted oral edoxaban', 'Uninterrupted Periprocedural Edoxaban', 'Edoxaban', 'uninterrupted edoxaban']","['plasma edoxaban concentration', 'composite of thromboembolism and major bleeding', 'efficacy and safety', 'plasma levels of coagulative biomarkers', 'Efficacy and Safety', 'periprocedural thromboembolic and bleeding complications', 'no thromboembolism and 1 major bleeding event']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",513.0,0.0305278,"For the primary endpoint, no thromboembolism and 1 major bleeding event (0.2%, cardiac tamponade) were observed.","[{'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology and Clinical Examination, Oita University Faculty of Medicine.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Mukai', 'Affiliation': 'Cardiology Division, Japanese Red Cross Fukuoka Hospital.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Medical Science Department, Daiichi Sankyo Co., Ltd.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Medical Science Department, Daiichi Sankyo Co., Ltd.'}, {'ForeName': 'Takuyuki', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Safety and Risk Management Department, Daiichi Sankyo Co., Ltd.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Origasa', 'Affiliation': 'Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0535']
1909,31554423,Comparison of the Effects of Ticagrelor and Clopidogrel on Microvascular Dysfunction in Patients With Acute Coronary Syndrome Using Invasive Physiologic Indices.,"BACKGROUND
Ticagrelor reduced the rate of myocardial infarction and death compared with clopidogrel in patients with acute coronary syndrome. However, little is understood about chronic treatment of ticagrelor on microvascular dysfunction. The objective of this study was to assess the impact of ticagrelor maintenance treatment on microvascular system and coronary flow in comparison with clopidogrel.
METHODS
This study was a nonblinded, open-label, parallel-group, prospective, randomized controlled trial that enrolled 120 patients with acute coronary syndrome requiring stent implantation. Patients were randomized into the ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300 to 600 mg loading dose, 75 mg daily thereafter) group. The primary end point was coronary microvascular dysfunction as measured by an index of microcirculatory resistance (IMR) at 6 months after treatment.
RESULTS
The baseline clinical characteristics and physiological parameters, such as fractional flow reserve, coronary flow reserve, and IMR, did not differ between the ticagrelor and clopidogrel groups. Six-month follow-up physiological data showed that the IMR value was significantly lower in the ticagrelor group than the clopidogrel group (15.57±5.65 versus 21.15±8.39, P <0.01), and coronary flow reserve was higher in the ticagrelor group than in the clopidogrel group (3.85±0.72 versus 3.37±0.76, P <0.01). However, there was no difference in fractional flow reserve (0.87±0.08 versus 0.87±0.09, P =0.94) between the 2 groups. The improvement in IMR after 6 months of treatment was higher in the ticagrelor group ( P <0.01). Analyses of 223 nonculprit vessels of registered patients based on physiological results showed no differences in baseline fractional flow reserve (0.93±0.13 versus 0.92±0.09, P =0.58), coronary flow reserve (3.62±1.27 versus 3.51±1.24, P =0.16), or IMR (21.37±12.37 versus 24.19±21.08, P =0.22) or in follow-up fractional flow reserve (0.91±0.09 versus 0.91±0.08, P =0.67), coronary flow reserve (3.91±1.22 versus 3.75±1.16, P =0.36), or IMR (19.43±10.32 versus 21.52±18.90, P =0.34) between the 2 groups.
CONCLUSIONS
Compared with clopidogrel, 6 months of ticagrelor therapy significantly improved microvascular dysfunction in acute coronary syndrome patients with stent implantation.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02618733.",2019,The improvement in IMR after 6 months of treatment was higher in the ticagrelor group ( P <0.01).,"['patients with acute coronary syndrome', 'Patients With Acute Coronary Syndrome Using Invasive Physiologic Indices', 'acute coronary syndrome patients with stent implantation', 'enrolled 120 patients with acute coronary syndrome requiring stent implantation']","['clopidogrel', 'Ticagrelor and Clopidogrel', 'Ticagrelor', 'ticagrelor therapy', 'ticagrelor', 'ticagrelor maintenance treatment']","['microvascular dysfunction', 'fractional flow reserve', 'IMR value', 'Microvascular Dysfunction', 'microvascular system and coronary flow', 'IMR', 'fractional flow reserve, coronary flow reserve, and IMR', 'coronary microvascular dysfunction as measured by an index of microcirculatory resistance (IMR', 'baseline fractional flow reserve', 'rate of myocardial infarction and death', 'coronary flow reserve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",120.0,0.0511629,The improvement in IMR after 6 months of treatment was higher in the ticagrelor group ( P <0.01).,"[{'ForeName': 'Kyungil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Young-Rak', 'Initials': 'YR', 'LastName': 'Cho', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Jong-Sung', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Moo-Hyun', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}, {'ForeName': 'Young-Dae', 'Initials': 'YD', 'LastName': 'Kim', 'Affiliation': 'Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008105']
1910,26700214,"Topical treatment for acute phase Peyronie's disease utilizing a new gel, H-100: a randomized, prospective, placebo-controlled pilot study.","Safety and efficacy of topically applied gel H-100 composed of Nicardipine, superoxide dismutase and emu oil for treatment of acute phase Peyronie's disease (PD) was evaluated. Twenty-two patients (PD <12 months duration) were studied in a prospective, randomized, double-blind, placebo-controlled study. Eleven patients received H-100 and 11 patients received placebo for 3 months. All 22 patients then received H-100 for the final 3 months. Flaccid-stretched penile length, degree of penile curvature, pain level and side effects were assessed monthly. H-100 showed significant improvement in all PD parameters at 6 months: mean stretched penile length increase (22.6%, P=0.0002), mean curvature reduction (40.8%, P=0.0014), and mean pain level reduction (85.7%, P=0.004). Placebo group showed no significant improvement except for mean stretched penile length increase (6.8%, P=0.009). Crossover patients from placebo to H-100 showed significant improvement in all parameters: mean stretched penile length increase (17.5%, P=0.000007), mean curvature reduction (37.1%, P=0.006), and mean pain level reduction (40%, P=0.17). Treatment was well tolerated. A self-limited rash was the only side effect in three patients. Statistically significant improvements in flaccid-stretched penile length, curvature and pain suggest that H-100 is a safe and possibly effective non-invasive, topically applied treatment for acute phase Peyronie's Disease.",2016,"mean stretched penile length increase (22.6%, P=0.0002), mean curvature reduction (40.8%, P=0.0014), and mean pain level reduction (85.7%, P=0.004).","['Twenty-two patients (PD <12 months duration', ""acute phase Peyronie's disease (PD""]","['Placebo', 'Topical treatment', 'placebo', 'Nicardipine, superoxide dismutase and emu oil']","['mean stretched penile length increase', 'PD parameters', 'tolerated', 'flaccid-stretched penile length, curvature and pain', 'Flaccid-stretched penile length, degree of penile curvature, pain level and side effects', 'mean curvature reduction', 'mean pain level reduction', 'Safety and efficacy', 'penile length increase']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0030848', 'cui_str': 'Peyronie Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C1337244', 'cui_str': 'EMU OIL'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231511', 'cui_str': 'Flaccid (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C2938970', 'cui_str': 'Penile curvature'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",22.0,0.0851056,"mean stretched penile length increase (22.6%, P=0.0002), mean curvature reduction (40.8%, P=0.0014), and mean pain level reduction (85.7%, P=0.004).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Twidwell', 'Affiliation': 'Urology Associates, Robbinsdale, MN, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Levine', 'Affiliation': 'Rush Medical College, Chicago, IL, USA.'}]",International journal of impotence research,['10.1038/ijir.2015.22']
1911,26543454,The effects of dexmedetomidine on attenuation of hemodynamic changes and there effects as adjuvant in anesthesia during laparoscopic surgeries.,"BACKGROUND
As an anesthetic adjuvant dexmedetomidine has been shown to provide good perioperative hemodynamic stability with minimum alveolar concentration sparing effect on inhalational anesthetic agents during laparoscopic surgeries performed under general anesthesia.
AIM
The study was planned to investigate the effects of dexmedetomidine on attenuation of hemodynamic changes and requirements of intra-operative analgesic and inhalational anesthetic during laparoscopic surgeries and its postoperative side effects.
MATERIALS AND METHODS
A total of 70 patients scheduled for elective laparoscopic surgeries were randomized to receive bolus infusion of dexmedetomidine (group D) or saline (group S) 1 mcg/kg/h, followed by continuous infusion of the same, at the rate of 0.5 mcg/kg/h. Anesthesia was maintained with nitrous oxide in oxygen, muscle relaxant and isoflurane. Supplementation with end-tidal isoflurane was considered when heart rate (HR) and mean arterial blood pressure (BP) exceeded 20% of the baseline value. Hemodynamics, end-tidal isoflurane concentration and adverse events were recorded.
RESULTS
Intra-operative mean HR and mean BP in group D were lower than group S (P < 0.05) throughout the laparoscopy surgery. Requirement of intra-operative fentanyl, end-tidal isoflurane and postoperative tramadol were significantly more in group S compared to group D (P < 0.05) Statistically significant nausea and vomiting were noted in group S. Undue sedation and other adverse effects are comparable in both the groups.
CONCLUSION
Dexmedetomidine as an adjuvant in general anesthesia for laparoscopic surgeries provided a stable hemodynamic profile in the perioperative period and effectively blunted pressor response to intubation and extubation, leading to minimal requirements for additional analgesics and potent inhalational agents. There were less adverse events.",2015,"RESULTS
Intra-operative mean HR and mean BP in group D were lower than group S (P < 0.05) throughout the laparoscopy surgery.","['anesthesia during laparoscopic surgeries', '70 patients scheduled for elective laparoscopic surgeries']","['intra-operative fentanyl, end-tidal isoflurane and postoperative tramadol', 'Dexmedetomidine', 'saline', 'Supplementation with end-tidal isoflurane', 'nitrous oxide in oxygen, muscle relaxant and isoflurane', 'dexmedetomidine']","['Hemodynamics, end-tidal isoflurane concentration and adverse events', 'nausea and vomiting', 'Intra-operative mean HR and mean BP', 'heart rate (HR) and mean arterial blood pressure (BP', 'adverse effects', 'adverse events']","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}]","[{'cui': 'C1961064', 'cui_str': 'ET isoflurane - end tidal isoflurane %'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",70.0,0.132307,"RESULTS
Intra-operative mean HR and mean BP in group D were lower than group S (P < 0.05) throughout the laparoscopy surgery.","[{'ForeName': 'Kalpana S', 'Initials': 'KS', 'LastName': 'Vora', 'Affiliation': 'Department of Anesthesia and Critical Care, G. R. Doshi and K. M. Mehta Institute of Kidney Diseases and Research Centre and Dr. H. L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Baranda', 'Affiliation': 'Department of Anesthesia and Critical Care, G. R. Doshi and K. M. Mehta Institute of Kidney Diseases and Research Centre and Dr. H. L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Veena R', 'Initials': 'VR', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesia and Critical Care, G. R. Doshi and K. M. Mehta Institute of Kidney Diseases and Research Centre and Dr. H. L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Modi', 'Affiliation': 'Department of Anesthesia and Critical Care, G. R. Doshi and K. M. Mehta Institute of Kidney Diseases and Research Centre and Dr. H. L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Geeta P', 'Initials': 'GP', 'LastName': 'Parikh', 'Affiliation': 'Department of Anesthesia and Critical Care, Institute of Kidney Diseases and Research Centre and Dr. H. L. Trivedi Institute of Transplantation Sciences, Asarwa, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Bina P', 'Initials': 'BP', 'LastName': 'Butala', 'Affiliation': 'Department of Anesthesia and Critical Care, Institute of Kidney Diseases and Research Centre and Dr. H. L. Trivedi Institute of Transplantation Sciences, Asarwa, Ahmedabad, Gujarat, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159461']
1912,26543455,Midazolam as an adjuvant to intrathecal lignocaine: A prospective randomized control study.,"CONTEXT
Unfortunately in the past decade, phenomenon of transient neurologic symptoms (TNS) cast doubts on the use of lignocaine for spinal anesthesia. Intrathecal midazolam has been proved to have its role in relieving neuropathic pain. We attempted to study the role of midazolam as an adjuvant to intrathecal lignocaine.
AIMS
The primary objective of the study was to evaluate the effect of intrathecal midazolam as an adjuvant to spinal lignocaine in terms of quality and duration of spinal sensory blockade. The secondary objectives are to study the effect on hemodynamics and the incidence of TNS.
SETTINGS AND DESIGN
A prospective randomized control double-blinded study in American Society of Anesthesiology I and II surgical population.
MATERIALS AND METHODS
Hundred healthy adult patients scheduled for elective infraumbilical surgery were randomly assigned to group A patients received spinal anesthesia with 1.5 ml of 5% lignocaine heavy with 0.4 ml of 0.9% saline and group B (control group) received spinal anesthesia with 1.5 ml of 5% heavy lignocaine with 0.4 ml of preservative-free 0.5% midazolam.
STATISTICAL ANALYSIS USED
Z test for study parameters and analysis of variance was used for hemodynamic parameters in the same group. P < 0.05 was considered statistically significant.
RESULTS
Midazolam resulted in improved quality of sensory blockade in terms of early onset, increased duration of effective analgesia, and delayed two segment regression time and also decreases the incidence of TNS with intrathecal lignocaine.
CONCLUSIONS
Midazolam is an effective adjuvant to intrathecal lignocaine.",2015,"RESULTS
Midazolam resulted in improved quality of sensory blockade in terms of early onset, increased duration of effective analgesia, and delayed two segment regression time and also decreases the incidence of TNS with intrathecal lignocaine.
","['American Society of Anesthesiology I and II surgical population', 'Hundred healthy adult patients scheduled for elective infraumbilical surgery']","['Midazolam', 'lignocaine', 'spinal lignocaine', 'intrathecal midazolam', 'midazolam', 'spinal anesthesia with 1.5 ml of 5% lignocaine heavy with 0.4 ml of 0.9% saline and group B (control group) received spinal anesthesia with 1.5 ml of 5% heavy lignocaine with 0.4 ml of preservative-free 0.5% midazolam', 'Intrathecal midazolam']","['quality and duration of spinal sensory blockade', 'quality of sensory blockade', 'duration of effective analgesia']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",0.0,0.0626422,"RESULTS
Midazolam resulted in improved quality of sensory blockade in terms of early onset, increased duration of effective analgesia, and delayed two segment regression time and also decreases the incidence of TNS with intrathecal lignocaine.
","[{'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Selvaraj', 'Affiliation': 'Department of Anesthesiology, MKCG Medical College, Berhampur University, Brahmapur, Odisha, India.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Ray', 'Affiliation': 'Department of Anesthesiology, MKCG Medical College, Berhampur University, Brahmapur, Odisha, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159462']
1913,26543457,Comparison of dexmedetomidine and clonidine as an adjuvant to ropivacaine for epidural anesthesia in lower abdominal and lower limb surgeries.,"BACKGROUND
The quality and duration of analgesia is improved when a local anesthetic is combined with alpha 2 adrenergic agonist. Though, the effects of clonidine on local anesthetics have been extensively studied, there are limited studies demonstrating the effects of epidural dexmedetomidine on local anesthetics. The aim of our study is to compare the effect of clonidine and dexmedetomidine when used as an adjuvant to epidural ropivacaine in lower abdominal and lower limb surgeries.
MATERIALS AND METHODS
Patients were randomized into two groups-group ropivacaine with clonidine (RC) received 15 ml of 0.75% ropivacaine with 1 μg/kg clonidine and group ropivacaine with dexmedetomidine (RD) received 15 ml of 0.75% ropivacaine with 1 μg/kg dexmedetomidine epidurally. Onset of sensory analgesia using cold swab, onset of motor blockade using Bromage scale, time to 2 dermatome regression of sensory level, time to first demand for analgesia, sedation using Ramsay sedation scale, intra operative hemodynamic parameters and complications were assessed.
RESULTS
The onset (RD-8.53 ± 1.81, RC-11.93 ± 1.96) and duration of sensory blockade (RD-316 ± 31.5, RC-281 ± 37, sedation were found to be significantly better in the dexmedetomidine group. No significant difference was found in terms of onset of motor blockade and hemodynamic changes.
CONCLUSION
Dexmedetomidine at doses of 1 μg/kg is an effective adjuvant to ropivacaine for epidural anesthesia, which is comparable to clonidine.",2015,"The onset (RD-8.53 ± 1.81, RC-11.93 ± 1.96) and duration of sensory blockade (RD-316 ± 31.5, RC-281 ± 37, sedation were found to be significantly better in the dexmedetomidine group.","['epidural anesthesia in lower abdominal and lower limb surgeries', 'Patients']","['dexmedetomidine and clonidine', 'Dexmedetomidine', 'epidural ropivacaine', 'clonidine and dexmedetomidine', 'clonidine', 'ropivacaine with clonidine (RC) received 15 ml of 0.75% ropivacaine', 'ropivacaine', 'clonidine and group ropivacaine with dexmedetomidine (RD) received 15 ml of 0.75% ropivacaine', 'dexmedetomidine']","['sensory level, time to first demand for analgesia, sedation using Ramsay sedation scale, intra operative hemodynamic parameters and complications', 'duration of sensory blockade (RD-316 ± 31.5, RC-281 ± 37, sedation', 'onset of motor blockade and hemodynamic changes']","[{'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0665454,"The onset (RD-8.53 ± 1.81, RC-11.93 ± 1.96) and duration of sensory blockade (RD-316 ± 31.5, RC-281 ± 37, sedation were found to be significantly better in the dexmedetomidine group.","[{'ForeName': 'Sruthi', 'Initials': 'S', 'LastName': 'Arunkumar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Puducherry, India.'}, {'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Hemanth Kumar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Puducherry, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Krishnaveni', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Puducherry, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ravishankar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Puducherry, India.'}, {'ForeName': 'Velraj', 'Initials': 'V', 'LastName': 'Jaya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Puducherry, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aruloli', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Puducherry, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159464']
1914,26543458,Endotracheal intubation without muscle relaxants in children using remifentanil and propofol: Comparative study.,"INTRODUCTION
Endotracheal intubation is essential during general anesthesia and muscle relaxant drugs provide ideal conditions for this purpose. The objective of this study was to evaluate the intubating condition of remifentanil combined with propofol without muscle relaxant.
MATERIALS AND METHODS
In this prospective randomized study, 60 children aged 3-12 years, American Society of Anesthesiologists physical status I and II were included. All the children were premedicated with 0.05 mg/kg midazolam and 1.5 mg/kg lidocaine 5 min before the induction of anesthesia with 3 mg/kg propofol. Then, they were allocated randomly to receive either 2 μg/kg remifentanil (group R) or 1.5 mg/kg succinylcholine (group S). Tracheal intubation was attempted 90 s after the administration of propofol. The quality of intubation was assessed by using Copenhagen score based on jaw relaxation, ease of laryngoscopy, position of vocal cord, coughing and limb movement. Heart rate and blood pressure were recorded before and after induction, and 1, 3, 5 min after intubation.
RESULTS
There was no significant difference in intubating condition between the two groups (P = 0.11). Intubation condition was excellent in 26 of 30 (86.7%) patients in the group R compared with 30 (100%) patients in the group S. We observed significant difference in heart rate and systolic blood pressure over time between two groups (P = 0.02, P = 0.03 respectively). After intubation, we had higher heart rate and systolic blood pressure with a significant difference in group S compared with group R (P = 0.006, P = 0.018). None of the children had a chest rigidity, laryngospasm, and hypoxia.
CONCLUSIONS
In premedicated children, propofol-remifentanil combination provides adequate conditions for tracheal intubation that is comparable with succinylcholine. Hemodynamic response to laryngoscopy and tracheal intubation was controlled better in group R.",2015,"After intubation, we had higher heart rate and systolic blood pressure with a significant difference in group S compared with group R (P = 0.006, P = 0.018).","['children using', '60 children aged 3-12 years, American Society of Anesthesiologists physical status I and II were included']","['remifentanil and propofol', 'Endotracheal intubation without muscle relaxants', 'lidocaine', 'midazolam', 'propofol', 'propofol-remifentanil combination', 'succinylcholine', 'anesthesia with 3 mg/kg propofol', 'remifentanil']","['Intubation condition', 'chest rigidity, laryngospasm, and hypoxia', 'heart rate and systolic blood pressure', 'Heart rate and blood pressure', 'Tracheal intubation', 'quality of intubation', 'intubating condition', 'Copenhagen score based on jaw relaxation, ease of laryngoscopy, position of vocal cord, coughing and limb movement', 'Hemodynamic response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0026837', 'cui_str': 'Rigidity, Muscular'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",60.0,0.132482,"After intubation, we had higher heart rate and systolic blood pressure with a significant difference in group S compared with group R (P = 0.006, P = 0.018).","[{'ForeName': 'Freshteh', 'Initials': 'F', 'LastName': 'Naziri', 'Affiliation': 'Department of Anesthesiology, Babol University of Medical Sciences, Babol, Mazandaran, Iran.'}, {'ForeName': 'Hakimeh Alereza', 'Initials': 'HA', 'LastName': 'Amiri', 'Affiliation': 'Department of Anesthesiology, Babol University of Medical Sciences, Babol, Mazandaran, Iran.'}, {'ForeName': 'Mozaffar', 'Initials': 'M', 'LastName': 'Rabiee', 'Affiliation': 'Department of Anesthesiology, Babol University of Medical Sciences, Babol, Mazandaran, Iran.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Banihashem', 'Affiliation': 'Department of Anesthesiology, Babol University of Medical Sciences, Babol, Mazandaran, Iran.'}, {'ForeName': 'Farhad Mohammad', 'Initials': 'FM', 'LastName': 'Nejad', 'Affiliation': 'Department of Anesthesiology, Babol University of Medical Sciences, Babol, Mazandaran, Iran.'}, {'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Shirkhani', 'Affiliation': 'Department of Anesthesiology, Babol University of Medical Sciences, Babol, Mazandaran, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Solimanian', 'Affiliation': 'Department of Anesthesiology, Babol University of Medical Sciences, Babol, Mazandaran, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159465']
1915,30655452,Sertraline or placebo in chronic breathlessness? Lessons from placebo research.,,2019,,[],"['Sertraline or placebo', 'placebo']",[],[],"[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.21493,,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'IMPACCT, University of Technology Sydney, Ultimo, Australia.'}]",The European respiratory journal,['10.1183/13993003.02316-2018']
1916,31553121,Conversations between people with aphasia and speech pathology students via telepractice: A Phase II feasibility study.,"BACKGROUND
Speech pathology students can experience low confidence when communicating with people with aphasia. Communication partner training (CPT) is one method to increase confidence and skills when communicating with people with aphasia. There is a paucity of research exploring the effects of delivering CPT to students via technology, such as telepractice.
AIMS
To explore the feasibility (acceptability, demand, implementation, practicality, limited efficacy) of a conversation with a person with aphasia via telepractice as part of a CPT programme with speech pathology students. A secondary aim was to explore the effects of feedback from the people with aphasia (i.e., patient feedback) on students' perceived confidence and proficiency in communicating with people with aphasia.
METHODS & PROCEDURES
A Phase II feasibility study design was used, where both quantitative and qualitative data were collected. A total of 33 speech pathology students attended a lecture about the strategies used to communicate effectively with people with aphasia. They then participated in a 10-min conversation via videoconferencing with a person with aphasia 1 week later. Students were randomly allocated to patient feedback or no patient feedback conditions. They completed a custom designed questionnaire pre- and post-conversation.
OUTCOMES & RESULTS
The study had a low recruitment rate but good retention. The programme was delivered as intended. Students reported that they found the conversations to be a positive but challenging experience. Post-conversation, statistically significant increases were found in students' self-rated confidence communicating with people with aphasia, proficiency at engaging in an everyday conversation and proficiency obtaining a case history (all p < 0.001). There were no significant differences for these ratings between the groups according to feedback condition (all p > 0.01).
CONCLUSIONS & IMPLICATIONS
CPT involving a conversation with a person with aphasia via telepractice is feasible and can provide a valuable learning experience for students. Further research is required.",2020,"Post-conversation, statistically significant increases were found in students' self-rated confidence communicating with people with aphasia, proficiency at engaging in an everyday conversation and proficiency obtaining a case history (all p < 0.001).","['people with aphasia and speech pathology students via telepractice', ""people with aphasia (i.e., patient feedback) on students' perceived confidence and proficiency in communicating with people with aphasia"", 'with speech pathology students', '33 speech pathology students']","['CPT programme', 'patient feedback or no patient feedback conditions', 'conversation with a person with aphasia via telepractice', 'Communication partner training (CPT']","[""students' self-rated confidence communicating with people with aphasia, proficiency at engaging in an everyday conversation and proficiency obtaining a case history"", 'feasibility (acceptability, demand, implementation, practicality, limited efficacy']","[{'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0080355', 'cui_str': 'Pathology, Speech'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}]","[{'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0085970', 'cui_str': 'Case Histories'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",33.0,0.0648059,"Post-conversation, statistically significant increases were found in students' self-rated confidence communicating with people with aphasia, proficiency at engaging in an everyday conversation and proficiency obtaining a case history (all p < 0.001).","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Finch', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lethlean', 'Affiliation': 'Speech Pathology Department, Princess Alexandra Hospital, Queensland Health, Woolloongabba, QLD, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Rose', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fleming', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Theodoros', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cameron', 'Affiliation': 'Speech Pathology Department, Princess Alexandra Hospital, Queensland Health, Woolloongabba, QLD, Australia.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Coleman', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Copland', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Centre for Functioning and Health Research, Metro South Health, Queensland Health, Buranda, QLD, Australia.'}]",International journal of language & communication disorders,['10.1111/1460-6984.12501']
1917,26543449,"Stress response in shoulder surgery under interscalene block, randomized controlled study comparing ultrasound guidance to nerve stimulation.","BACKGROUND
Shoulder surgeries are known to cause moderate to severe pain. Many techniques have been used successfully to minimize that stress response including interscalene block. Ultrasound guided techniques are becoming widely spread and commonly used for regional anesthesia. The objective of the present randomized controlled study is to compare the ultrasound guidance with nerve stimulation for interscalene brachial plexus block (IBPB) regarding the effect on stress response.
PATIENTS AND METHODS
50 patients, American Society of Anesthesiologists physical status I, II, and III, undergoing shoulder surgery were enrolled in the current study. Group U patients (n = 25) received ultrasound guided IBPB and Group N patients (n = 25) received IBPB using nerve locator. IBPB was done under ultrasound guidance using the linear 13-6 MHz transducer of the SonoSite M-Turbo ultrasonic device. In both groups, venous blood samples to measure cortisol level and assess stress response as a primary outcome were collected.
RESULTS
The current study demonstrated that the stress response, as indicated by the cortisol level in blood, showed no significant difference in the preoperative blood level between Group U and Group N, as well as blood level after block and before skin incision. However, it differed significantly between the two groups postoperatively.
CONCLUSION
The current study concluded that the use of ultrasound guidance for IBPB in shoulder surgeries offered a significant suppression of the stress response intraoperatively and postoperatively as indicated by the low cortisol level with less complications and easier technique compared to nerve location.",2015,"However, it differed significantly between the two groups postoperatively.
","['shoulder surgery under interscalene block', '50 patients, American Society of Anesthesiologists physical status']","['ultrasound guidance to nerve stimulation', 'interscalene brachial plexus block (IBPB', 'IBPB using nerve locator', 'ultrasound guidance with nerve stimulation', 'ultrasound guided IBPB']","['Stress response', 'venous blood samples to measure cortisol level and assess stress response', 'cortisol level in blood', 'blood level', 'preoperative blood level']","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",50.0,0.034792,"However, it differed significantly between the two groups postoperatively.
","[{'ForeName': 'Hossam A', 'Initials': 'HA', 'LastName': 'Elshamaa', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159454']
1918,26543450,"Effect of ondansetron on prevention of post-induction hypotension in elderly patients undergoing general anesthesia: A randomized, double-blind placebo-controlled clinical trial.","BACKGROUND
Elderly patients are susceptible to post-induction hypotension. Volume loading and vasopressors for prevention of hypotension in elderly patients may increase perioperative cardiovascular risks. Ondansetron by blocking Bezold-Jarisch reflex (BJR) through inhibition of serotonin receptors has been effective in the prevention of post-spinal hypotension, and bradycardia. Bradycardia frequently accompanies post-induction hypotension in elderly patients, which signifies a possible preventing role for ondansetron. No previous study has evaluated the prophylactic effects of ondansetron for the prevention of post-induction hypotension.
MATERIALS AND METHODS
In this randomized placebo-controlled clinical trial, ondansetron 4 mg was given intravenously to 65 elderly patients, 20 min before induction of general anesthesia, and the rate of post-induction hypotension defined as 25% or more reduction in mean arterial blood pressure, compared with a placebo groups.
RESULTS
A total of 114 patients completed the study (58 in ondansetron and 56 in the placebo group). Proportions of post-induction hypotension were 9 (16%) and 25 (45%) in ondansetron and placebo groups, respectively, (P = 0.001). Forty-five patients (40%) developed bradycardia. Rates of bradycardia were not significantly different between two groups.
CONCLUSIONS
The results of this study show the effectiveness of intravenous ondansetron for prevention of post-induction hypotension in elderly patients. The mechanism of this effect largely is unknown. Role of ondansetron for prevention of post-induction hypotension may not fully understandable by its interaction with BJR, as has been shown in post-spinal hypotension.",2015,"Proportions of post-induction hypotension were 9 (16%) and 25 (45%) in ondansetron and placebo groups, respectively, (P = 0.001).","['114 patients completed the study (58 in ondansetron and 56 in the placebo group', 'Elderly patients', '65 elderly patients', 'elderly patients undergoing general anesthesia', 'elderly patients']","['Ondansetron', 'placebo', 'ondansetron']","['Proportions of post-induction hypotension', 'perioperative cardiovascular risks', 'prevention of post-induction hypotension', 'mean arterial blood pressure', 'Rates of bradycardia', 'bradycardia']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}]",114.0,0.493653,"Proportions of post-induction hypotension were 9 (16%) and 25 (45%) in ondansetron and placebo groups, respectively, (P = 0.001).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Golparvar', 'Affiliation': 'Department of Anesthesia, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Saghaei', 'Affiliation': 'Department of Anesthesia, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Saadati', 'Affiliation': 'Department of Anesthesia, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Farsaei', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159455']
1919,26543452,Comparative study between paracetamol and two different doses of pregabalin on postoperative pain in laparoscopic cholecystectomy.,"BACKGROUND
Postoperative pain is the primary reason for prolonged hospital stay after laparoscopic cholecystectomy. This study compared the effect of a single oral preoperative administration of paracetamol (1 g) with 2 different doses of pregabalin (150 or 300 mg) for attenuating postoperative pain and analgesic consumption.
MATERIALS AND METHODS
Seventy-five patients, aged 18-60 years, American Society of Anesthesiologists' physical status I and II undergoing elective laparoscopic cholecystectomy were included in this randomized controlled study. Patients were divided into three groups, 25 each to receive either oral paracetamol 1 g (group I, control group) or pregabalin 150 (group II) or 300 mg (group III), 2 h before surgery. Postoperative pain was evaluated based on visual analog scale over a period of 6 h and 1(st) time for rescue analgesia. Postoperative sedation, hemodynamic changes, serum cortisol level, and side effects were also evaluated.
RESULTS
There was a significant decrease in mean heart rate, mean systolic blood pressure, sedation score, pain score, and delayed the first request for analgesics postoperatively in group (II) and group (III) compared to group (I) 2 h postoperatively. There was no significant difference in group (III) compared to group (II) postoperatively. The incidence of postoperative side effects was more in group (III).
CONCLUSION
The single oral preoperative dose administration of pregabalin had significant opioid-sparing effect in the first 6 h after surgery, whereas side effects were more common with administration of pregabalin 300 mg.",2015,"There was a significant decrease in mean heart rate, mean systolic blood pressure, sedation score, pain score, and delayed the first request for analgesics postoperatively in group (II) and group (III) compared to group (I) 2 h postoperatively.","['laparoscopic cholecystectomy', 'I and II undergoing elective laparoscopic cholecystectomy', ""Seventy-five patients, aged 18-60 years, American Society of Anesthesiologists' physical status"", 'prolonged hospital stay after laparoscopic cholecystectomy']","['paracetamol', 'pregabalin', 'oral paracetamol']","['Postoperative pain', 'side effects', 'visual analog scale over a period of 6 h and 1(st) time for rescue analgesia', 'postoperative pain', 'postoperative side effects', 'Postoperative sedation, hemodynamic changes, serum cortisol level, and side effects', 'mean heart rate, mean systolic blood pressure, sedation score, pain score, and delayed the first request for analgesics postoperatively']","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.0222715,"There was a significant decrease in mean heart rate, mean systolic blood pressure, sedation score, pain score, and delayed the first request for analgesics postoperatively in group (II) and group (III) compared to group (I) 2 h postoperatively.","[{'ForeName': 'Ibrahim M', 'Initials': 'IM', 'LastName': 'Esmat', 'Affiliation': 'Lecturer of Anesthesia and Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Hanan M', 'Initials': 'HM', 'LastName': 'Farag', 'Affiliation': 'Lecturer of Anesthesia and Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.159459']
1920,26452769,"Fat Reduction Efforts: A 24-Month Longitudinal Comparison of a Large Sample of Maintainers, Relapsers, and Non-Changers.","This research examined dynamic transtheoretical model (TTM) constructs for dietary fat reduction. This secondary data analysis pooled three large population-based TTM-tailored school, worksite, medical, and home-based intervention studies and examined use of constructs across three groups organized by longitudinal progress (dynatypes): Maintainers, Relapsers, and Stable Non-Changers. The criteria for successful change, at the time, were that less than 30% of calories came from fat. A total of 2,718 adults met criteria for an unhealthy diet at baseline. The majority of participants were female, White, married, and middle-aged. Demographics, Stage of Change, Processes of Change, Decisional Balance, and Temptations were measured. Dynatype groups were assessed with reliable and valid scales assessing constructs at baseline and 6, 12, and 24 months. Analyses included a multivariate analysis of variance followed by a series of analyses of variance, with Tukey follow-up tests assessing differences in use of TTM constructs across the three groups at each time point. Relapsers and Maintainers were similar in their use of all TTM Processes of Change at baseline, with the exception of Self-Liberation (η(2) = 0.15, p < .001) and Reinforcement Management (η(2) = 0.01, p < .001). Although Relapsers reverted to an unhealthy diet, their overall greater use of Processes of Change suggests that their behaviors and strategy use remain better than that of the Stable Non-Changer group. Results suggest that specific cognitive and behavioral constructs may contribute differentially to intervention outcomes.",2016,"Relapsers and Maintainers were similar in their use of all TTM Processes of Change at baseline, with the exception of Self-Liberation (η(2) = 0.15, p < .001) and Reinforcement Management (η(2) = 0.01, p < .001).","['participants were female, White, married, and middle-aged', '2,718 adults met criteria for an unhealthy diet at baseline']",[],"['Demographics, Stage of Change, Processes of Change, Decisional Balance, and Temptations']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3805118', 'cui_str': 'Unhealthy diet'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",2718.0,0.0248106,"Relapsers and Maintainers were similar in their use of all TTM Processes of Change at baseline, with the exception of Self-Liberation (η(2) = 0.15, p < .001) and Reinforcement Management (η(2) = 0.01, p < .001).","[{'ForeName': 'Miryam', 'Initials': 'M', 'LastName': 'Yusufov', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA miryam_yusufov@my.uri.edu.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Paiva', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Redding', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Lipschitz', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'N Simay', 'Initials': 'NS', 'LastName': 'Gokbayrak', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Greene', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Rossi', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Blissmer', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Wayne F', 'Initials': 'WF', 'LastName': 'Velicer', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Prochaska', 'Affiliation': 'University of Rhode Island, Kingston, RI, USA.'}]",Health promotion practice,['10.1177/1524839915606423']
1921,30575484,Sorafenib for Advanced and Refractory Desmoid Tumors.,"BACKGROUND
Desmoid tumors (also referred to as aggressive fibromatosis) are connective tissue neoplasms that can arise in any anatomical location and infiltrate the mesentery, neurovascular structures, and visceral organs. There is no standard of care.
METHODS
In this double-blind, phase 3 trial, we randomly assigned 87 patients with progressive, symptomatic, or recurrent desmoid tumors to receive either sorafenib (400-mg tablet once daily) or matching placebo. Crossover to the sorafenib group was permitted for patients in the placebo group who had disease progression. The primary end point was investigator-assessed progression-free survival; rates of objective response and adverse events were also evaluated.
RESULTS
With a median follow-up of 27.2 months, the 2-year progression-free survival rate was 81% (95% confidence interval [CI], 69 to 96) in the sorafenib group and 36% (95% CI, 22 to 57) in the placebo group (hazard ratio for progression or death, 0.13; 95% CI, 0.05 to 0.31; P<0.001). Before crossover, the objective response rate was 33% (95% CI, 20 to 48) in the sorafenib group and 20% (95% CI, 8 to 38) in the placebo group. The median time to an objective response among patients who had a response was 9.6 months (interquartile range, 6.6 to 16.7) in the sorafenib group and 13.3 months (interquartile range, 11.2 to 31.1) in the placebo group. The objective responses are ongoing. Among patients who received sorafenib, the most frequently reported adverse events were grade 1 or 2 events of rash (73%), fatigue (67%), hypertension (55%), and diarrhea (51%).
CONCLUSIONS
Among patients with progressive, refractory, or symptomatic desmoid tumors, sorafenib significantly prolonged progression-free survival and induced durable responses. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT02066181 .).",2018,"Before crossover, the objective response rate was 33% (95% CI, 20 to 48) in the sorafenib group and 20% (95% CI, 8 to 38) in the placebo group.","['87 patients with progressive, symptomatic, or recurrent desmoid tumors to receive either', 'Advanced and Refractory Desmoid Tumors', 'group who had disease progression']","['Sorafenib', 'sorafenib (400-mg tablet once daily) or matching placebo', 'sorafenib', 'placebo']","['fatigue', 'median time to an objective response', 'investigator-assessed progression-free survival; rates of objective response and adverse events', '2-year progression-free survival rate', 'adverse events', 'progression-free survival', 'hypertension', 'objective response rate', 'diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0079218', 'cui_str': 'Desmoid'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",87.0,0.569801,"Before crossover, the objective response rate was 33% (95% CI, 20 to 48) in the sorafenib group and 20% (95% CI, 8 to 38) in the placebo group.","[{'ForeName': 'Mrinal M', 'Initials': 'MM', 'LastName': 'Gounder', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Mahoney', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Van Tine', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Ravi', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Hari A', 'Initials': 'HA', 'LastName': 'Deshpande', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Abha A', 'Initials': 'AA', 'LastName': 'Gupta', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Milhem', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Conry', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Sujana', 'Initials': 'S', 'LastName': 'Movva', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Pishvaian', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Riedel', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sabagh', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tap', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Natally', 'Initials': 'N', 'LastName': 'Horvat', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Schwartz', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Narasimhan P', 'Initials': 'NP', 'LastName': 'Agaram', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lefkowitz', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Mazaheri', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Rikiya', 'Initials': 'R', 'LastName': 'Yamashita', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Wright', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}, {'ForeName': 'Gary K', 'Initials': 'GK', 'LastName': 'Schwartz', 'Affiliation': 'From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center (M.M.G., W.D.T., N.H., N.P.A., R.A.L., Y.M., R.Y.) and Columbia University Vagellos College of Physicians and Surgeons and New York Presbyterian Hospital (L.H.S., G.K.S.), New York, and Northwell Cancer Institute and Cold Spring Harbor Laboratory, Lake Success (R.G.M.) - all in New York; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (M.R.M.); Washington University School of Medicine, St. Louis (B.A.V.T.); M.D. Anderson Cancer Center, University of Texas, Houston (V.R.); Mayo Clinic in Florida, Jacksonville (S.A.); Yale University, New Haven, CT (H.A.D.); University Health Network Princess Margaret Cancer Centre, Toronto (A.A.G.); University of Iowa-Holden Comprehensive Cancer Center, Iowa City (M.M.M.); University of Alabama at Birmingham Cancer Center, Birmingham (R.M.C.); Fox Chase Cancer Center, Philadelphia (S.M.); Georgetown University, Lombardi Comprehensive Cancer Center, Washington, DC (M.J.P.); Duke Cancer Institute, Duke University Medical Center, Durham (R.F.R.), and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill (E.B.) - both in North Carolina; Dayton National Cancer Institute Community Oncology Research Program, Dayton, OH (T.S.); National Cancer Institute, Bethesda, MD (J.J.W.); and the Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ (A.C.D.).'}]",The New England journal of medicine,['10.1056/NEJMoa1805052']
1922,31819377,Efficacy and Safety of Combined Vitrectomy with Intravitreal Dexamethasone Implant for Advanced Stage Epiretinal Membrane.,"Purpose
To evaluate the efficacy and safety of combined 25-gauge (G) pars plana vitrectomy (PPV) with intravitreal dexamethasone implant (DXI) for the treatment of advanced stage epiretinal membrane (ERM).
Methods
Forty consecutive pseudophakic eyes with idiopathic stage 3-4 ERM and intraretinal cysts were randomly assigned to two treatment groups. Twenty eyes underwent combined 25-G PPV, ERM peeling and slow-release DXI (DEX group), whereas 20 eyes underwent standard 25-G PPV with ERM peeling only (control group). Differences in postoperative best-corrected visual acuity (BCVA), intraocular pressure (IOP), central macular thickness (CMT) were evaluated.
Results
In all patients, BCVA significantly increased at 1, 3 and 6 months after surgery compared to baseline (all p < 0.05), but at 3 and 6 months, the visual gain was higher in the DEX group (respectively, p = 0.036, p = 0.006). CMT was significantly lower in DEX group compared to control group at 3 and 6 months after surgery (respectively, p = 0.042, p = 0.003). There was no statistically significant difference in IOP change over the course of the follow-up between groups ( p > 0.05).
Conclusion
Combined 25-G PPV with DXI is associated with better anatomical and functional outcomes in patients with advanced stage ERM.",2019,"There was no statistically significant difference in IOP change over the course of the follow-up between groups ( p > 0.05).
","['Twenty eyes underwent', 'patients with advanced stage ERM', 'advanced stage epiretinal membrane (ERM', 'Forty consecutive pseudophakic eyes with idiopathic stage 3-4 ERM and intraretinal cysts', 'Advanced Stage Epiretinal Membrane']","['combined 25-gauge (G) pars plana vitrectomy (PPV) with intravitreal dexamethasone implant (DXI', 'standard 25-G PPV with ERM peeling', 'ERM peeling and slow-release DXI (DEX', 'DEX', 'Combined Vitrectomy with Intravitreal Dexamethasone Implant', 'combined 25-G PPV']","['CMT', 'visual gain', 'postoperative best-corrected visual acuity (BCVA), intraocular pressure (IOP), central macular thickness (CMT', 'BCVA', 'efficacy and safety', 'IOP change', 'Efficacy and Safety']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal Membrane'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach (procedure)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456638', 'cui_str': '25G (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",40.0,0.089511,"There was no statistically significant difference in IOP change over the course of the follow-up between groups ( p > 0.05).
","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Iovino', 'Affiliation': 'Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giannaccare', 'Affiliation': 'Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bernabei', 'Affiliation': 'Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Braghiroli', 'Affiliation': 'Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Tomaso', 'Initials': 'T', 'LastName': 'Caporossi', 'Affiliation': 'Department of Ophthalmology, Ospedale Careggi, Firenze, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Peiretti', 'Affiliation': 'Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Italy.'}]","Drug design, development and therapy",['10.2147/DDDT.S229031']
1923,30764710,Father's Involvement When Bringing Baby Home: Efficacy Testing of a Couple-Focused Transition to Parenthood Intervention for Promoting Father Involvement.,"The goal of the present research was to test the efficacy of the Bringing Baby Home couple-focused psychoeducational program for promoting father involvement and related satisfaction. A randomized clinical trial design was used to randomly assign 136 pregnant couples to either an intervention or control group. Father involvement post-intervention was assessed through self-report of engagement in parenting tasks. Intent-to-treat analysis of covariance analyses indicated that fathers who participated in the Bringing Baby Home program reported significantly more involvement in parenting tasks, satisfaction with the division of parenting labor, and feeling appreciated by their wives. Both husbands and wives were also more satisfied with the division of labor when fathers were more involved in parenting. Results suggest that couple-focused psychoeducational programs can be successful for promoting father involvement.",2020,"Intent-to-treat analysis of covariance analyses indicated that fathers who participated in the Bringing Baby Home program reported significantly more involvement in parenting tasks, satisfaction with the division of parenting labor, and feeling appreciated by their wives.","['136 pregnant couples to either an intervention or control group', ""Father's Involvement""]","['Couple-Focused Transition to Parenthood Intervention', 'Baby Home couple-focused psychoeducational program']","['parenting tasks, satisfaction with the division of parenting labor, and feeling']","[{'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0337469', 'cui_str': 'Parenthood (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",136.0,0.0279515,"Intent-to-treat analysis of covariance analyses indicated that fathers who participated in the Bringing Baby Home program reported significantly more involvement in parenting tasks, satisfaction with the division of parenting labor, and feeling appreciated by their wives.","[{'ForeName': 'Alyson F', 'Initials': 'AF', 'LastName': 'Shapiro', 'Affiliation': 'Department of Child and Family Development, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Gottman', 'Affiliation': 'Relationship Research Institute, The Gottman Institute and the Department of Psychology at the University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Brandi C', 'Initials': 'BC', 'LastName': 'Fink', 'Affiliation': 'Department Psychiatry and Behavioral Sciences, University of New Mexico, Albuquerque, NM, USA.'}]",Psychological reports,['10.1177/0033294119829436']
1924,27051359,"A comparison between intrathecal clonidine and neostigmine as an adjuvant to bupivacaine in the subarachnoid block for elective abdominal hysterectomy operations: A prospective, double-blind and randomized controlled study.","BACKGROUND AND AIMS
Adjuvant to the local anesthetic agent has proven benefits when used intrathecally. With regards to intrathecal bupivacaine as control, we have compared in this study the effects of clonidine and neostigmine when co-administered intrathecally with hyperbaric (0.5%) bupivacaine for abdominal hysterectomy.
MATERIALS AND METHODS
This prospective, randomized, double-blind study was conducted from May 2009 to June 2011. A total of 150 patients of American Society of Anaesthesiology grades I and II scheduled for abdominal hysterectomy under spinal anesthesia were randomly allocated into three groups. A volume of 3 ml of 0.5% hyperbaric bupivacaine was respectively added 1 ml solution containing 5% dextrose and 75 mcg of neostigmine in Group N, 1 ml containing 5% dextrose and 30 mcg of clonidine in Group C and 1 ml of 5% dextrose in Group D (control). We compared the sensory and motor block, the surgical condition, the duration of spinal analgesia and the side-effect profile.
RESULTS AND OBSERVATIONS
Sensory and motor blocks and duration of spinal analgesia were significantly increased in both Group C and Group N compared to Group D. More incidences of Nausea and vomiting were observed in Group N compared to other groups. The surgical condition was poorer in Group N compared to Group C.
CONCLUSION
Both intrathecal clonidine and neostigmine increase the bupivacaine-induced spinal block. However, clonidine provides better surgical condition and fewer incidences of nausea and vomiting.",2016,"RESULTS AND OBSERVATIONS
Sensory and motor blocks and duration of spinal analgesia were significantly increased in both Group C and Group N compared to Group D.","['I and II scheduled for abdominal hysterectomy under spinal anesthesia', 'May 2009 to June 2011', 'elective abdominal hysterectomy operations', '150 patients of American Society of Anaesthesiology grades']","['clonidine and neostigmine', 'hyperbaric bupivacaine', 'intrathecal clonidine', 'neostigmine', 'dextrose and 30 mcg of clonidine', 'bupivacaine', 'intrathecal bupivacaine', 'clonidine', 'intrathecal clonidine and neostigmine', 'hyperbaric (0.5%) bupivacaine']","['Nausea and vomiting', 'nausea and vomiting', 'Sensory and motor blocks and duration of spinal analgesia']","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}]",,0.146148,"RESULTS AND OBSERVATIONS
Sensory and motor blocks and duration of spinal analgesia were significantly increased in both Group C and Group N compared to Group D.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bhar', 'Affiliation': 'Department of Anaesthesiology, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'RoyBasunia', 'Affiliation': 'Department of Anaesthesiology, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kundu', 'Affiliation': 'Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Mondal', 'Affiliation': 'Department of Gynecology and Obstetrics, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Halder', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of Gynecology and Obstetrics, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.168797']
1925,27051361,Effect of intraoperative magnesium intravenous infusion on the hemodynamic changes associated with right lobe living donor hepatotomy under transesophageal Doppler monitoring-randomized controlled trial.,"BACKGROUND
Liver donors are subjected to specific postresection hemodynamic changes. The aim was to monitor these changes and to evaluate the effect of magnesium sulfate infusion (MgSO4) on these changes together with total anesthetic agents consumption.
PATIENTS AND METHODS
A total of 50 donors scheduled for right hepatotomy were divided into two equal groups. Controls (C) received saline and magnesium group (Mg) received MgSO4 10% (30 mg/kg over 20 min) administered immediately after induction of anesthesia, followed by infusion (10 mg/kg/h) till the end of surgery. Hemodynamics, transesophageal Doppler (TED) data and anesthetic depth guided by Entropy were recorded.
RESULTS
Postresection both groups demonstrated an increase in heart rate (HR) and cardiac output (COP) in association with lowering of systemic vascular resistance (SVR). The increase in HR with Mg was lower when compared with C, P = 0.00. Increase in COP was lower with Mg compared to (C) (6.1 ± 1.3 vs. 7.5 ± 1.6 L/min, P = 0.00) and with less reduction in SVR compared to C (1145 ± 251 vs. 849.2 ± 215 dynes.s/cm(5), P < 0.01), respectively. Sevoflurane consumption was lower with Mg compared to C (157.1 ± 35.1 vs. 187.6 ± 25.6 ml, respectively, P = 0.001). Reduced fentanyl and rocuronium consumption in Mg group are compared to C (P = 0.00). Extubation time, postoperative patient-controlled fentanyl were lower in Mg than C (P = 0.001).
CONCLUSION
TED was able to detect significant hemodynamic changes associated with major hepatotomy. Prophylactic magnesium helped to reduce these changes with lower anesthetic and analgesics consumption and an improvement in postoperative pain relief.",2016,"Extubation time, postoperative patient-controlled fentanyl were lower in Mg than C (P = 0.001).
",['50 donors scheduled for right hepatotomy'],"['Prophylactic magnesium', 'magnesium sulfate infusion (MgSO4', 'intraoperative magnesium intravenous infusion', 'MgSO4', 'saline and magnesium']","['COP', 'SVR', 'Extubation time, postoperative patient-controlled fentanyl', 'fentanyl and rocuronium consumption', 'Sevoflurane consumption', 'increase in HR with Mg', 'postoperative pain relief', 'heart rate (HR) and cardiac output (COP', 'Hemodynamics, transesophageal Doppler (TED) data and anesthetic depth guided by Entropy', 'systemic vascular resistance (SVR']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0193377', 'cui_str': 'Incision of liver (procedure)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0522518', 'cui_str': 'Transesophageal approach (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}]",50.0,0.122581,"Extubation time, postoperative patient-controlled fentanyl were lower in Mg than C (P = 0.001).
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Anesthesia, National Liver Institute, Menoufiya University, Sheben ELkom City, Menoufiya, Egypt.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sayed', 'Affiliation': 'Department of Anesthesia, National Liver Institute, Menoufiya University, Sheben ELkom City, Menoufiya, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eskander', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Menoufiya University, Sheben ELkom City, Menoufiya, Egypt.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'ElSheikh', 'Affiliation': 'Department of Anesthesia, National Liver Institute, Menoufiya University, Sheben ELkom City, Menoufiya, Egypt.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lotfy', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Menoufiya University, Sheben ELkom City, Menoufiya, Egypt.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yassen', 'Affiliation': 'Department of Anesthesia, National Liver Institute, Menoufiya University, Sheben ELkom City, Menoufiya, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.168799']
1926,27051362,Efficacy of two doses of tramadol versus bupivacaine in perioperative caudal analgesia in adult hemorrhoidectomy.,"BACKGROUND
The study was conducted to evaluate the perioperative analgesic efficacy of the two doses of caudally administered tramadol versus bupivacaine in adult hemorrhoidectomy.
PATIENTS AND METHODS
A total of 90 patients, aged 20-50 years, undergoing hemorrhoidectomy were randomly scheduled to receive bupivacaine 0.25% in 20 ml (Group B; n = 30), tramadol 1 mg/kg in 20 ml (Group T1; n = 30), tramadol 2 mg/kg in 20 ml (Group T2; n = 30) through caudal route after induction of general anesthesia. Postoperative pain was assessed every hour until the visual analog scale was 6, which is 1(st) time for rescue analgesia. Postoperative sedation, hemodynamic changes, serum cortisol, and epinephrine levels and incidence of side effects were also evaluated.
RESULTS
Duration of analgesia was longer in Group T2 (20 [1.14] h] compared with the Group B (7 [1.2] h) or Group T1 (12 [0.75] h); all P < 0.001. There were no significant hemodynamic changes. There were not incidences of side effects.
CONCLUSION
Caudal tramadol 2 mg/kg provided a longer duration of postoperative analgesia with rapid onset and no incidence of complications or adverse effects in adult hemorrhoidectomy.",2016,Caudal tramadol 2 mg/kg provided a longer duration of postoperative analgesia with rapid onset and no incidence of complications or adverse effects in adult hemorrhoidectomy.,"['adult hemorrhoidectomy', '90 patients, aged 20-50 years, undergoing hemorrhoidectomy']","['Caudal tramadol', 'tramadol 1 mg/kg in 20 ml', 'tramadol', 'bupivacaine']","['perioperative analgesic efficacy', 'Postoperative pain', 'Duration of analgesia', 'side effects', 'hemodynamic changes', 'Postoperative sedation, hemodynamic changes, serum cortisol, and epinephrine levels and incidence of side effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0201998', 'cui_str': 'Adrenaline measurement'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",90.0,0.243353,Caudal tramadol 2 mg/kg provided a longer duration of postoperative analgesia with rapid onset and no incidence of complications or adverse effects in adult hemorrhoidectomy.,"[{'ForeName': 'Hanan M', 'Initials': 'HM', 'LastName': 'Farag', 'Affiliation': 'Department of Anesthesia and Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim M', 'Initials': 'IM', 'LastName': 'Esmat', 'Affiliation': 'Department of Anesthesia and Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.168801']
1927,27051365,Comparison of caudal tramadol versus caudal fentanyl with bupivacaine for prolongation of postoperative analgesia in pediatric patients.,"BACKGROUND AND AIMS
Caudal block is a common technique for pediatric analgesia for infraumblical surgeries. Because of the short duration of analgesia with bupivacaine alone various additive have been used to prolong the action of bupivacaine. The present study was aimed to evaluate the analgesic effect of tramadol or fentanyl added to bupivacaine for infraumblical surgeries in pediatric patients.
MATERIALS AND METHODS
We conducted a prospective, randomized, single-blind controlled trial. After written informed consent from parents, 100 patients belonging to American Society of Anesthesiologist physical status I-II, in the age group of 1-12 years, of either sex undergoing infraumblical surgery under general anesthesia were divided into two groups. Group BT received 1 ml/kg of 0.25% bupivacaine with tramadol 2 mg/kg in normal saline and Group BF received 1 ml/kg of 0.25% bupivacaine with fentanyl 2 μg/kg in normal saline with maximum volume of 12 ml in both groups. All patients were assessed intraoperatively for hemodynamic changes, the requirement of sevoflurane concentration, as well as postoperatively for pain by using FLACC (F = Face, L = Leg, A = Activity, C = Cry, C = Consolability), pain score and for sedation by using four point sedation score.
RESULTS
The mean duration of analgesia was 10-18 h in Group BT while in Group BF it was 7-11 h. The postoperatively period up to 1½ h, Group BF had higher sedation score up to two as compared to that below one on Group BT.
CONCLUSION
Caudal tramadol significantly prolongs the duration of analgesia as compared to caudal fentanyl without any side effects.",2016,"The postoperatively period up to 1½ h, Group BF had higher sedation score up to two as compared to that below one on Group BT.
","['pediatric patients', '100 patients belonging to American Society of Anesthesiologist physical status I-II, in the age group of 1-12 years, of either sex undergoing infraumblical surgery under general anesthesia']","['caudal tramadol versus caudal fentanyl with bupivacaine', 'bupivacaine', 'Caudal tramadol', 'tramadol or fentanyl', 'bupivacaine with tramadol 2 mg/kg in normal saline and Group BF received 1 ml/kg of 0.25% bupivacaine with fentanyl 2 μg/kg in normal saline']","['mean duration of analgesia', 'pain score and for sedation by using four point sedation score', 'duration of analgesia', 'sedation score', 'analgesic effect']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",100.0,0.0976897,"The postoperatively period up to 1½ h, Group BF had higher sedation score up to two as compared to that below one on Group BT.
","[{'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Solanki', 'Affiliation': 'Department of Anesthesia, B. J. Medical College and Civil Hospital, Asarwa, Ahmedabad, Gujarat, India.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Engineer', 'Affiliation': 'Department of Anesthesia, B. J. Medical College and Civil Hospital, Asarwa, Ahmedabad, Gujarat, India.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Jansari', 'Affiliation': 'Department of Anesthesia, B. J. Medical College and Civil Hospital, Asarwa, Ahmedabad, Gujarat, India.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Patel', 'Affiliation': 'Department of Anesthesia, B. J. Medical College and Civil Hospital, Asarwa, Ahmedabad, Gujarat, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.168807']
1928,30941887,Micronutrient powder supplements combined with nutrition education marginally improve growth amongst children aged 6-23 months in rural Burkina Faso: A cluster randomized controlled trial.,"Micronutrients powder (MNP) can prevent anaemia amongst children 6-23 months old. However, evidence of an effect on growth is limited and concerns about the safety of iron-containing MNP interventions limits their applicability. In a cluster randomized controlled intervention, we evaluated the effectiveness of a nutritional package including counselling and provision of MNP to improve the nutritional status of children aged 6-23 months and the effect of sustained use of MNP on morbidity in a malaria-endemic area. Child feeding practises and nutritional status were assessed through cross-sectional surveys. Biweekly morbidity surveillance and anthropometry measurements were carried out in a nested cohort study. No significant differences in the prevalence of wasting (-0.7% [-6.8, 5.3] points; p = .805), stunting (+4.6% [-2.9, 12.0] points; p = .201), or mean length-for-age z-score and weight-for-length z-score scores were found between study groups. The proportion of children with a minimum dietary diversity score and those with a minimum acceptable diet significantly increased in the intervention group compared with the control by 6.5% points (p = .043) and 5.8% points (p = .037), respectively. There were no significant differences in the risk of diarrhoea (RR: 1.68, 95% CI [0.94, 3.08]), fever (RR: 1.20 [0.82, 1.77]), and malaria (RR: 0.68 [0.37, 1.26]) between study groups. In the nested study, the rate of linear growth was higher in the intervention than in the control group by 0.013 SD/month (p = .027). In a programmatic intervention, MNP and nutrition education marginally improved child feeding practises and growth, without increasing morbidity from malaria or fever.",2019,"The proportion of children with a minimum dietary diversity score and those with a minimum acceptable diet significantly increased in the intervention group compared with the control by 6.5% points (p = .043) and 5.8% points (p = .037), respectively.","['children aged 6-23\xa0months in rural Burkina Faso', 'children 6-23\xa0months old', 'children aged 6-23\xa0months']","['MNP', 'Micronutrients powder (MNP', 'nutritional package including counselling and provision of MNP', 'Micronutrient powder supplements combined with nutrition education']","['proportion of children with a minimum dietary diversity score', 'fever', 'morbidity from malaria or fever', 'mean length-for-age z-score and weight-for-length z-score scores', 'prevalence of wasting', 'Biweekly morbidity surveillance and anthropometry measurements', 'rate of linear growth', 'risk of diarrhoea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.09083,"The proportion of children with a minimum dietary diversity score and those with a minimum acceptable diet significantly increased in the intervention group compared with the control by 6.5% points (p = .043) and 5.8% points (p = .037), respectively.","[{'ForeName': 'Hermann B', 'Initials': 'HB', 'LastName': 'Lanou', 'Affiliation': 'Ministry of Higher Education, Scientific Research and Innovation, Institut de Recherche en Sciences de la Santé, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Saskia J M', 'Initials': 'SJM', 'LastName': 'Osendarp', 'Affiliation': 'Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Argaw', 'Affiliation': 'Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kirrily', 'Initials': 'K', 'LastName': 'De Polnay', 'Affiliation': 'Child Health and Nutrition Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ouédraogo', 'Affiliation': 'Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Seni', 'Initials': 'S', 'LastName': 'Kouanda', 'Affiliation': 'Ministry of Higher Education, Scientific Research and Innovation, Institut de Recherche en Sciences de la Santé, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kolsteren', 'Affiliation': 'Child Health and Nutrition Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}]",Maternal & child nutrition,['10.1111/mcn.12820']
1929,26955303,"Pain relief after ambulatory hand surgery: A comparison between dexmedetomidine and clonidine as adjuvant in axillary brachial plexus block: A prospective, double-blinded, randomized controlled study.","BACKGROUND
For ages various adjuvants have been tried to prolong axillary brachial plexus block. We compared the effect of adding dexmedetomidine versus clonidine to ropivacaine for axillary brachial plexus blockade. The primary endpoints were the onset and duration of sensory and motor block and duration of analgesia.
MATERIALS AND METHODS
A total of 90 patients (20-40 years) posted for ambulatory elective hand surgery under axillary brachial plexus block were divided into two equal groups (groups ropivacaine dexmedetomidine [RD] and ropivacaine clonidine [RC]) in a randomized, double-blind fashion. In group RD (n = 45) 30 ml 0.5% ropivacaine + 100 μg of dexmedetomidine and group RC (n = 45) 30 ml 0.5% ropivacaine + 75 μg clonidine were administered in axillary plexus block. Sensory and motor block onset times and block durations, time to first analgesic use, total analgesic need, postoperative visual analog scale (VAS), hemodynamics and side-effects were recorded for each patient.
RESULTS
Though with similar demographic profile in both groups, sensory and motor block in group RD (P < 0.05) was earlier than group RC. Sensory and motor block duration and time to first analgesic use were significantly longer and the total need for rescue analgesics was lower in group RD (P < 0.05) than group RC. Postoperative VAS value at 18 h were significantly lower in group RD (P < 0.05). Intraoperative hemodynamics were insignificantly lower in group RD (P < 0.05) without any appreciable side-effects.
CONCLUSION
It can be concluded that adding dexmedetomidine to axillary plexus block increases the sensory and motor block duration and time to first analgesic use, and decreases total analgesic use with no side-effects.",2016,"Intraoperative hemodynamics were insignificantly lower in group RD (P < 0.05) without any appreciable side-effects.
","['axillary brachial plexus blockade', '90 patients (20-40 years) posted for ambulatory elective hand surgery under axillary brachial plexus block', 'axillary brachial plexus block']","['dexmedetomidine and clonidine', 'clonidine', 'ambulatory hand surgery', 'ropivacaine dexmedetomidine [RD', 'ropivacaine', 'ropivacaine clonidine [RC', 'dexmedetomidine']","['Pain relief', 'Postoperative VAS value', 'Sensory and motor block onset times and block durations, time to first analgesic use, total analgesic need, postoperative visual analog scale (VAS), hemodynamics and side-effects', 'onset and duration of sensory and motor block and duration of analgesia', 'Intraoperative hemodynamics', 'Sensory and motor block duration and time to first analgesic use', 'total need for rescue analgesics', 'sensory and motor block']","[{'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0394701', 'cui_str': 'Brachial plexus block by axillary approach (procedure)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",90.0,0.0840651,"Intraoperative hemodynamics were insignificantly lower in group RD (P < 0.05) without any appreciable side-effects.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Orthopedics, R. G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chhaule', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Banu', 'Affiliation': 'Department of G and O, Berhampore, West Bengal, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mandal', 'Affiliation': 'Department of G and O, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chandra', 'Affiliation': 'Department of Orthopedics, R. G. Kar Medical College, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169443']
1930,32416779,Trial and error.,,2020,,[],[],[],[],[],[],,0.0803244,,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ofri', 'Affiliation': 'Bellevue Hospital, NYU School of Medicine, New York, NY 10016, USA. Electronic address: danielle.ofri@nyumc.org.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30965-X']
1931,32416538,"Peer outreach point-of-care testing as a bridge to hepatitis C care for people who inject drugs in Toronto, Canada.","BACKGROUND
People who inject drugs have high rates of hepatitis C (HCV) and yet many remain undiagnosed and untreated. HCV treatment guidelines and elimination strategies recommend task-shifting to expand where, and by whom, HCV testing and care is delivered.
METHODS
A randomized controlled trial design was used to evaluate if point-of-care (POC) HCV antibody testing by peer outreach workers outside of health and social service spaces would improve engagement in HCV care. People with a lifetime history of injection drug use without prior knowledge of HCV antibody status were randomized to receive HCV outreach plus either POC or referral to community-based HCV program for testing as usual. The study was co-designed by people with lived experience of HCV.
RESULTS
920 people were approached to participate over 14 weeks. After refusals, withdrawals and removal of duplicates, there were 380 study participants. Outreach took place primarily in public spaces (66%) such as parks, coffee shops and apartment lobbies. Participants reported very high rates of poverty, housing instability and recent injection drug use. Despite being at high risk for HCV, 61% had no history or knowledge of past HCV testing (n = 230). Of those who received a POC test 77/195 (39%) were positive for HCV antibodies. There was no change in rates of engagement in HCV care among those who received the POC (n = 6; 3%) compared to those who did not (n = 5; 3%).
CONCLUSION
Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing. This improved participants' knowledge of their HCV antibody status, but that knowledge in itself did not lead to any change in participant's subsequent engagement in HCV care. Future work is required to evaluate strategies such as incentives or peer navigators to improve linkage to HCV care after diagnosis.",2020,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"['people with lived experience of HCV', '920 people were approached to participate over 14 weeks', 'by peer outreach workers outside of health and social service spaces', 'People with a lifetime history of injection drug use without prior knowledge of HCV antibody status', 'people who inject drugs in Toronto, Canada']","['HCV outreach plus either POC or referral to community-based HCV program', 'care (POC) HCV antibody testing']",['rates of engagement in HCV care'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]",920.0,0.0380034,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Broad', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mason', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Guyton', 'Affiliation': 'Sherbourne Health, 333 Sherbourne St, Toronto, ON M5A 2S5, Canada.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Lettner', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada; Regent Park Community Health Centre, 465 Dundas St East, Toronto, ON M5A 2B2, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'University Health Network, 235 - 200 Elizabeth St, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Powis', 'Affiliation': 'Michael Garron Hospital, 825 Coxwell Ave, Toronto, ON M4C 3E7, Canada. Electronic address: jeff.powis@tehn.ca.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102755']
1932,26955315,"Induced hypotension in ambulatory functional endoscopic sinus surgery: A comparison between dexmedetomidine and clonidine as premedication. A prospective, double-blind, and randomized study.","BACKGROUND
Functional endoscopic sinus surgery (FESS) is the mainstay of a therapeutic technique for nasal pathologies. This study is to compare the ability of preoperative dexmedetomidine versus clonidine for producing controlled hypotensive anesthesia during FESS in adults in an ambulatory care setting.
MATERIALS AND METHODS
Sixty patients (25-50 years) posted for ambulatory FESS procedures under general anesthesia were randomly divided into Group C and D (n = 33 each) receiving dexmedetomidine 1 μg/kg and clonidine 1.5 μg/kg, respectively; both diluted in 100 ml saline solution 15 min before anesthetic induction. Nasal bleeding and surgeon's satisfaction score; amount and number of patients receiving fentanyl and nitroglycerine for analgesia and deliberate hypotension, duration of hypotension, post anesthesia care unit (PACU) and hospital stay; hemodynamic parameters and side effects were recorded for each patient.
RESULTS
Number and dosage of nitroglycerine used was significantly (P = 0.034 and 0.0001 respectively) lower in Group D compared to that in Group C. Similarly, number of patients requiring fentanyl and dosage of same was significantly lower in Group D. But, the duration of controlled hypotension was almost similar in both the groups. Group D patients suffered from significantly less nasal bleeding and surgeon's satisfaction score was also high in this group. Discharge from PACU was significantly earlier in Group D, but hospital discharge timing was quite comparable among two groups. Intraoperative hemodynamics was significantly lower in Group D (P < 0.05) without any appreciable side effects.
CONCLUSION
Dexmedetomidine found to be providing more effectively controlled hypotension and analgesia, and thus, allowing less nasal bleeding as well as more surgeons' satisfaction score.",2016,"RESULTS
Number and dosage of nitroglycerine used was significantly (P = 0.034 and 0.0001 respectively) lower in Group D compared to that in Group C. Similarly, number of patients requiring fentanyl and dosage of same was significantly lower in Group D.","['ambulatory functional endoscopic sinus surgery', 'Sixty patients (25-50 years) posted for ambulatory FESS procedures under general anesthesia', 'adults in an ambulatory care setting']","['fentanyl and nitroglycerine', 'Dexmedetomidine', 'clonidine', 'Functional endoscopic sinus surgery (FESS', 'dexmedetomidine 1 μg/kg and clonidine 1.5 μg/kg, respectively; both diluted in 100 ml saline solution', 'dexmedetomidine']","['hospital discharge timing', ""Nasal bleeding and surgeon's satisfaction score"", 'Intraoperative hemodynamics', 'nasal bleeding', ""nasal bleeding and surgeon's satisfaction score"", 'Induced hypotension', 'duration of controlled hypotension', 'analgesia and deliberate hypotension, duration of hypotension, post anesthesia care unit (PACU) and hospital stay; hemodynamic parameters and side effects']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0354612,"RESULTS
Number and dosage of nitroglycerine used was significantly (P = 0.034 and 0.0001 respectively) lower in Group D compared to that in Group C. Similarly, number of patients requiring fentanyl and dosage of same was significantly lower in Group D.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukherje', 'Affiliation': 'Department of Anaesthesiology, N.R.S Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chhaule', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Halder', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Basunia', 'Affiliation': 'Department of Anaesthesiology, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169480']
1933,27051371,Adding magnesium sulfate to bupivacaine in transversus abdominis plane block for laparoscopic cholecystectomy: A single blinded randomized controlled trial.,"INTRODUCTION AND AIM
Use of transversus abdominis plane block (TAP) in the management of postoperative pain after the laparoscopic cholecystectomy (LC) has been a common anesthetic practice. This study evaluates the effect of adding magnesium sulfate to bupivacaine in TAP block in LC regarding postoperative analgesia and analgesic consumption.
PATIENTS AND METHODS
Ninety patients of American Society of Anesthesiologists I and II was divided into three groups: Control group (C group, n = 30), bupivacaine group (B group, n = 30), bupivacaine magnesium group (M group, n = 30).
RESULTS
M group showed better analgesic profile in the 1(st) postoperative day in the form of lower mean visual analog scale score (2.8 ± 0.6 for C group, 2.1 ± 0.5 for B group, 2.2 ± 0.5 for M group, P < 0.001), longer duration of analgesia (7 ± 2.8 h for C group, 16 ± 2.5 h for B group, 19 ± 2.2 h for M group, P < 0.006), lower morphine consumption (2 ± 0.1 mg for C group, 0.9 ± 0.1 mg for B group, 0.5 ± 0.1 mg for M group, P < 0.011). There was a significant lower incidence of postoperative nausea and vomiting (PONV) (32% for C group, 6% B group, 7% M group, P < 0.004).
CONCLUSION
Adding MgSo4 as an adjuvant to bupivacaine in TAP block; during anesthesia for LC; improved postoperative analgesia in the form of increased duration, decreased analgesic requirements and PONV.",2016,"There was a significant lower incidence of postoperative nausea and vomiting (PONV) (32% for C group, 6% B group, 7% M group, P < 0.004).
","['Ninety patients of American Society of Anesthesiologists I and II', 'transversus abdominis plane block for laparoscopic cholecystectomy']","['magnesium sulfate', 'bupivacaine magnesium', 'transversus abdominis plane block (TAP', 'bupivacaine', 'laparoscopic cholecystectomy (LC', 'magnesium sulfate to bupivacaine']","['analgesic profile', 'postoperative analgesia', 'analgesic requirements and PONV', 'postoperative nausea and vomiting (PONV', 'lower morphine consumption', 'mean visual analog scale score', 'longer duration of analgesia']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",90.0,0.0542227,"There was a significant lower incidence of postoperative nausea and vomiting (PONV) (32% for C group, 6% B group, 7% M group, P < 0.004).
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Al-Refaey', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Usama', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Al-Hefnawey', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Mansoura University, Mansoura, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.168821']
1934,27051372,A randomized placebo-controlled trial to evaluate a novel noninjectable anesthetic gel with thermosetting agent during scaling and root planing in chronic periodontitis patients.,"AIM
To study the efficacy of a noninjectable anesthetic gel with a thermosetting agent in the reduction of pain during scaling and root planing (SRP) in untreated chronic periodontitis patients.
MATERIALS AND METHODS
This study is a randomized, double-masked, split-mouth, placebo-controlled trial. Thirty patients were enrolled who underwent SRP in a split-mouth (right side/left side) manner. Before commencement of SRP, both quadrants on each side were isolated and had a randomized gel (either placebo or test gel) placed in the periodontal pockets for 30 s. The pain was measured using numerical rating scale (NRS) and verbal rating scale (VRS).
RESULTS
The median NRS pain score for the patients treated with the anesthetic test gel was 1 (range: 0-4) as opposed to 5 (range: 3-7) in the placebo treated patients. The mean rank of pain score using NRS in test gel was 16.18 as compared to 44.82 in placebo treated sites. Hence, significant reduction in pain was found in test gel as compared to placebo using NRS (P < 0.001). The VRS showed that the majority of patients reported no pain or mild pain with a median of 1 as compared to placebo treated sites with a median of 2 suggestive of moderate pain.
CONCLUSIONS
The NRS and VRS pain scores showed that the side treated with anesthetic gel was statistically more effective than the placebo in reducing pain during SRP.",2016,The NRS and VRS pain scores showed that the side treated with anesthetic gel was statistically more effective than the placebo in reducing pain during SRP.,"['chronic periodontitis patients', 'Thirty patients were enrolled who underwent SRP in a split-mouth (right side/left side) manner', 'untreated chronic periodontitis patients']","['novel noninjectable anesthetic gel with thermosetting agent during scaling and root planing', 'placebo', 'noninjectable anesthetic gel']","['pain', 'median NRS pain score', 'pain or mild pain', 'mean rank of pain score', 'numerical rating scale (NRS) and verbal rating scale (VRS', 'NRS and VRS pain scores', 'pain during scaling and root planing (SRP']","[{'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0444532', 'cui_str': 'Right sided (qualifier value)'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale (assessment scale)'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}]",30.0,0.507632,The NRS and VRS pain scores showed that the side treated with anesthetic gel was statistically more effective than the placebo in reducing pain during SRP.,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Dayakar', 'Affiliation': 'Department of Periodontics, KVG Dental College and Hospital, Sullia, DK, Karnataka, India.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Akbar', 'Affiliation': 'Department of Periodontics, KVG Dental College and Hospital, Sullia, DK, Karnataka, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.168823']
1935,27051374,Clinical performance of cuffed versus uncuffed preformed endotracheal tube in pediatric patients undergoing cleft palate surgery.,"BACKGROUND
Uncuffed endotracheal tubes are commonly used in children but due to several decade preferred in paediatric oral surgery. Due to lack of conclusive evidences in this regard, we have conducted this study to compare post-operative morbidity following use of cuffed and uncuffed endotracheal tubes in paediatric patients undergoing cleft lip-palate surgery.
METHODS
This randomised controlled trial was conducted on children aged 2 to 12 years.110 patients were allocated in two parallel groups using computer generated list of random numbers. Post operative extubation stridor, sore throat, time to first oral intake and regaining of normal voice were compared between two groups.
RESULTS
The incidence of sore throat was significantly more (P value > 0.005) in patients of uncuffed group compared to cuffed group. The time to first oral intake and time to regain normal voice were significantly earlier in cuffed group compared to the other.
CONCLUSION
With standard care, preformed cuffed ET tube has shown reduced incidence of post operative sore throat. Cuffed group has earlier oral intake and normal voice regain compared to uncuffed group.",2016,The incidence of sore throat was significantly more (P value > 0.005) in patients of uncuffed group compared to cuffed group.,"['pediatric patients undergoing cleft palate surgery', 'children aged 2 to 12 years.110 patients', 'paediatric patients undergoing cleft lip-palate surgery']","['Uncuffed endotracheal tubes', 'cuffed and uncuffed endotracheal tubes', 'cuffed versus uncuffed preformed endotracheal tube']","['time to first oral intake and time to regain normal voice', 'Post operative extubation stridor, sore throat, time to first oral intake and regaining of normal voice', 'incidence of sore throat']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008924', 'cui_str': 'Harelip'}, {'cui': 'C0700374', 'cui_str': 'Palate'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C1720479', 'cui_str': 'Preformed endotracheal tube'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0234759', 'cui_str': 'Normal voice (finding)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0038450', 'cui_str': 'Stridor'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.0873483,The incidence of sore throat was significantly more (P value > 0.005) in patients of uncuffed group compared to cuffed group.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Anaesthesiology and Critical Care, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Anaesthesiology and Critical Care, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Department of Anaesthesiology and Critical Care, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Anaesthesiology and Critical Care, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ganguly', 'Affiliation': 'Department of Anaesthesiology and Critical Care, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.168842']
1936,27051376,Is it time for routine use of the retromolar fiberscope?,"PURPOSE
This study aimed to determine the effectiveness, safety, and oral intubation time (IT) using a retromolar Bonfils fiberoptic scope compared with a conventional Macintosh laryngoscope.
MATERIALS AND METHODS
Sixty patients (16-60 years old, American Society of Anesthesiology I/II) scheduled for general anesthesia for elective ear-nose-throat and plastic surgery were randomly divided into a Bonfils group (Group B, n = 30) and a Macintosh group (Group M, n = 30). Exclusion criteria included Mallampati IV, thyromental distance ≤4 cm, mouth <4 cm, cervical spine problems, body mass index >35, sleep apnea, reflux esophagitis, coronary artery disease, intracranial vascular malformation, elevated intracranial pressure, bleeding disorders, allergies to planned drugs, and patient refusal. Mallampati scoring, mouth opening, and thyromental distance were used for airway assessment. The time needed for successful intubation (IT), number of attempts, number of failures, systolic (SBP), diastolic (DBP), mean blood pressure (MBP), heart rate (HR) and Oxygen saturation (O2) and damage to the lips, dentures, and pharyngeal or laryngeal structures were recorded. Continuous variables are presented as mean ± standard deviation and categorical variables are presented as frequency and percentage. Chi-square tests and Student's t-tests were used to compare the groups. P < 0.05 was considered statistically significant.
RESULTS
The groups were comparable regarding demographic data, preoperative airway parameters, IT, the number of attempts, O2, and the incidence of complications (P > 0.05). However, Bonfils intubation was associated with more stable HR, SBP, DBP and MBP (P < 0.05).
CONCLUSION
The Bonfils fiberoptic scope is comparable to a Macintosh laryngoscope but assures better hemodynamic stability. In difficult cases, the Bonfils scope is a better choice because of its ability to navigate.",2016,"However, Bonfils intubation was associated with more stable HR, SBP, DBP and MBP (P < 0.05).
","['Sixty patients (16-60 years old, American Society of Anesthesiology I/II) scheduled for general anesthesia for elective ear-nose-throat and plastic surgery', 'Exclusion criteria included Mallampati IV, thyromental distance ≤4 cm, mouth <4 cm, cervical spine problems, body mass index >35, sleep apnea, reflux esophagitis, coronary artery disease, intracranial vascular malformation, elevated intracranial pressure, bleeding disorders, allergies to planned drugs, and patient refusal']",[],"['hemodynamic stability', 'Mallampati scoring, mouth opening, and thyromental distance', 'demographic data, preoperative airway parameters, IT, the number of attempts, O2, and the incidence of complications', 'effectiveness, safety, and oral intubation time (IT', 'stable HR, SBP, DBP and MBP', 'time needed for successful intubation (IT), number of attempts, number of failures, systolic (SBP), diastolic (DBP), mean blood pressure (MBP), heart rate (HR) and Oxygen saturation (O2) and damage to the lips, dentures, and pharyngeal or laryngeal structures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C0230069', 'cui_str': 'Structure of anterior portion of neck'}, {'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1959923', 'cui_str': 'Thyroid to mentum distance'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0677659', 'cui_str': 'Gastroesophageal reflux disease with esophagitis (disorder)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C3839297', 'cui_str': 'Congenital intracranial vascular malformation (disorder)'}, {'cui': 'C0151740', 'cui_str': 'Intracranial Pressure Increase'}, {'cui': 'C1458140', 'cui_str': 'Tendency to bleed (observable entity)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",[],"[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1959923', 'cui_str': 'Thyroid to mentum distance'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0662675', 'cui_str': '(18F)MBP'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}]",60.0,0.0288288,"However, Bonfils intubation was associated with more stable HR, SBP, DBP and MBP (P < 0.05).
","[{'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Shallik', 'Affiliation': 'Department of Anestheisa, Hamad Medical Corporation, Doha, Qatar; Department of Anestheisa, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed Hassan', 'Initials': 'MH', 'LastName': 'Soliman', 'Affiliation': 'Department of Anestheisa, Hamad Medical Corporation, Doha, Qatar; Department of Anestheisa, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Sami M', 'Initials': 'SM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anestheisa, Hamad Medical Corporation, Doha, Qatar; Department of Anestheisa, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Algeziry', 'Affiliation': 'Department of Anestheisa, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Mohamed Magdy', 'Initials': 'MM', 'LastName': 'Hussein', 'Affiliation': 'Department of Anestheisa, Hamad Medical Corporation, Doha, Qatar; Department of Anestheisa, Al-Azhar University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.177418']
1937,30859503,"Capsule Commentary on Anthenelli et al., Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial.",,2019,,[],[],[],[],[],[],,0.052487,,"[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, CA, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Young-Wolff', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04909-8']
1938,26952155,In Response: Dexmedetomidine versus propofol in dilatation and curettage: An open-label pilot randomized controlled trial.,,2016,,['dilatation and curettage'],"['propofol', 'Dexmedetomidine']",[],"[{'cui': 'C0012358', 'cui_str': 'D&C'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.087441,,"[{'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Tomar', 'Affiliation': 'Department of Neuroanaesthesiology and Critical Care, AIIMS, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169493']
1939,26955304,"Multiple levels paravertebral block versus morphine patient-controlled analgesia for postoperative analgesia following breast cancer surgery with unilateral lumpectomy, and axillary lymph nodes dissection.","BACKGROUND
Postoperative pain after breast cancer surgery is not uncommon. Narcotic based analgesia is commonly used for postoperative pain management. However, the side-effects and complications of systemic narcotics is a significant disadvantage. Different locoregional anesthetic techniques have been tried including, single and multiple levels paravertebral block (PVB), which seems to have a significant reduction in immediate postoperative pain with fewer side-effects. The aim of this study was to compare unilateral multiple level PVB versus morphine patient-controlled analgesia (PCA) for pain relief after breast cancer surgery with unilateral lumpectomy and axillary lymph nodes dissection.
MATERIALS AND METHODS
Forty patients scheduled for breast cancer surgery were randomized to receive either preoperative unilateral multiple injections PVB at five thoracic dermatomes (group P, 20 patients) or postoperative intravenous PCA with morphine (group M, 20 patients) for postoperative pain control. Numerical pain scale, mean arterial pressure, heart rate, Time to first analgesic demand, 24-h morphine consumption side-effects and length of hospital stay were recorded.
RESULTS
PVB resulted in a significantly more postoperative analgesia, maintained hemodynamic, more significant reduction in nausea and vomiting, and shorter hospital stay compared with PCA patients.
CONCLUSION
Multiple levels PVB is an effective regional anesthetic technique for postoperative pain management, it provides superior analgesia with less narcotics consumption, and fewer side-effects compared with PCA morphine for patients with breast cancer who undergo unilateral lumpectomy, with axillary lymph nodes dissection.",2016,"RESULTS
PVB resulted in a significantly more postoperative analgesia, maintained hemodynamic, more significant reduction in nausea and vomiting, and shorter hospital stay compared with PCA patients.
","['Forty patients scheduled for breast cancer surgery', 'breast cancer surgery with unilateral lumpectomy, and axillary lymph nodes dissection', 'pain relief after breast cancer surgery with unilateral lumpectomy and axillary lymph nodes dissection', 'patients with breast cancer who undergo unilateral lumpectomy, with axillary lymph nodes dissection']","['PCA morphine', 'morphine patient-controlled analgesia', 'postoperative pain control', 'Narcotic based analgesia', 'morphine patient-controlled analgesia (PCA', 'preoperative unilateral multiple injections PVB at five thoracic dermatomes (group P, 20 patients) or postoperative intravenous PCA with morphine']","['postoperative analgesia, maintained hemodynamic', 'nausea and vomiting, and shorter hospital stay', 'Numerical pain scale, mean arterial pressure, heart rate, Time to first analgesic demand, 24-h morphine consumption side-effects and length of hospital stay']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",40.0,0.0613596,"RESULTS
PVB resulted in a significantly more postoperative analgesia, maintained hemodynamic, more significant reduction in nausea and vomiting, and shorter hospital stay compared with PCA patients.
","[{'ForeName': 'Summayah', 'Initials': 'S', 'LastName': 'Fallatah', 'Affiliation': 'Department of Anesthesia, Surgical ICU and Pain Medicine, College of Medicine, University of Dammam, Al Khober, Saudi Arabia.'}, {'ForeName': 'W F', 'Initials': 'WF', 'LastName': 'Mousa', 'Affiliation': 'Department of Anesthesia, Surgical ICU and Pain Medicine, College of Medicine, University of Dammam, Al Khober, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169468']
1940,26955305,Effects of perineural administration of dexmedetomidine in combination with bupivacaine in a femoral-sciatic nerve block.,"BACKGROUND AND AIM
Perineural administration of dexmedetomidine, a α2-adrenoceptor agonist, prolongs the duration of analgesia. We hypothesized that adding dexmedetomidine to bupivacaine would prolong postoperative analgesia after below knee surgery.
MATERIALS AND METHODS
After ethical approval, 60 patients scheduled for below knee surgery under combined femoral-sciatic nerve block were randomly allocated into two groups to have their block performed using bupivacaine 0.5% alone (group B) or bupivacaine 0.5% combined with 100 μg bupivacaine-dexmedetomidine (group BD). Motor and sensory block onset times; durations of blockades and analgesia were recorded.
RESULTS
Sensory and motor block onset times were shorter by 20% in group BD than in group B (P < 0.01). Sensory and motor blockade durations were longer in group BD (+45% and +40%, respectively) than in group B (P < 0.01). Duration of analgesia was longer in group BD by 75% than in group B (P < 0.01). Systolic, diastolic arterial blood pressure levels, and heart rate were significantly less in group BD, six patients in group BD, and no patients in group B developed bradycardia (P < 0.05).
CONCLUSION
The addition of dexmedetomidine 100 μg to bupivacaine 0.5% during ultrasound-guided combined femoral and sciatic block for below knee surgery was associated with a prolonged duration of analgesia. However, this may be associated with significant bradycardia requiring treatment.",2016,"Systolic, diastolic arterial blood pressure levels, and heart rate were significantly less in group BD, six patients in group BD, and no patients in group B developed bradycardia (P < 0.05).
","['60 patients scheduled for below knee surgery under combined femoral-sciatic nerve block', 'a femoral-sciatic nerve block']","['bupivacaine 0.5% combined with 100 μg bupivacaine-dexmedetomidine', 'bupivacaine', 'ultrasound-guided combined femoral and sciatic block', 'bupivacaine 0.5% alone', 'dexmedetomidine']","['postoperative analgesia', 'Duration of analgesia', 'Sensory and motor block onset times', 'Systolic, diastolic arterial blood pressure levels, and heart rate', 'Sensory and motor blockade durations', 'bradycardia']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve (procedure)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}]",60.0,0.121417,"Systolic, diastolic arterial blood pressure levels, and heart rate were significantly less in group BD, six patients in group BD, and no patients in group B developed bradycardia (P < 0.05).
","[{'ForeName': 'Safaa M', 'Initials': 'SM', 'LastName': 'Helal', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Menoufia University, Shebin El Kom, Menoufia, Egypt.'}, {'ForeName': 'Ashraf M', 'Initials': 'AM', 'LastName': 'Eskandr', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Menoufia University, Shebin El Kom, Menoufia, Egypt.'}, {'ForeName': 'Khaled M', 'Initials': 'KM', 'LastName': 'Gaballah', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Menoufia University, Shebin El Kom, Menoufia, Egypt.'}, {'ForeName': 'Ihab S', 'Initials': 'IS', 'LastName': 'Gaarour', 'Affiliation': 'Department of Anesthesiology, King Fahd Hospital of the University of Dammam, Al Khobar, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169469']
1941,26955306,Ultrasound-guided rectus sheath and transversus abdominis plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled study.,"BACKGROUND
Regional anesthetic techniques can be used to alleviate postoperative pain in patients undergoing major upper abdominal surgery. Our aim was to evaluate the efficacy of bilateral ultrasound (US)-guided rectus sheath (RS) and transversus abdominis plane (TAP) blocks for better perioperative analgesia.
PATIENTS AND METHODS
It is a prospective, observer-blinded, randomized clinical study. 40 eligible patients undergoing elective liver resection or Whipple procedure were included. All patients received a standardized anesthetic technique. Group 1 (n = 20) received preincisional US-guided bilateral RS and TAP blocks using 20 ml volume of bupivacaine 0.25% for each, and group 2 (n = 20) received local wound infiltration at end of surgery with 40 ml of bupivacaine 0.25%. A standardized postoperative analgesic regimen composed of intravenous paracetamol and a morphine patient-controlled analgesia (PCA). The use of intraoperative fentanyl and recovery room morphine boluses, PCA-administered morphine, pain scores as well as number of patients' experienced postoperative nausea and vomiting in the ward at 6 and 24 h were recorded.
RESULTS
Group 1 patients received a significantly lower cumulative intraoperative fentanyl, significantly lesser boluses of morphine in postanesthesia care unit, as well, significantly lower cumulative 24 h postoperative morphine dosage than the group 2 patients. Pain visual analog scale scores were significantly lower at both 6 and 24 h postoperatively in TAP group when compared with the no-TAP group. There were no complications related to the TAP block procedures. No signs or symptoms of local anesthetic systemic toxicity were detected.
CONCLUSION
The combination of bilateral US-guided RS and TAP blocks provides excellent perioperative analgesia for major upper abdominal surgery.",2016,Pain visual analog scale scores were significantly lower at both 6 and 24 h postoperatively in TAP group when compared with the no-TAP group.,"['40 eligible patients undergoing elective liver resection or Whipple procedure were included', 'patients undergoing major upper abdominal surgery', 'upper abdominal surgery', 'major upper abdominal surgery']","['morphine', 'standardized anesthetic technique', 'bilateral ultrasound (US)-guided rectus sheath (RS) and transversus abdominis plane (TAP) blocks', 'bilateral US-guided RS and TAP blocks', 'bupivacaine', 'paracetamol', 'local wound infiltration at end of surgery with 40 ml of bupivacaine', 'intraoperative fentanyl and recovery room morphine boluses, PCA-administered morphine', 'Ultrasound-guided rectus sheath and transversus abdominis plane blocks', 'morphine patient-controlled analgesia (PCA', 'preincisional US-guided bilateral RS and TAP blocks']","['cumulative intraoperative fentanyl', 'signs or symptoms of local anesthetic systemic toxicity', 'Pain visual analog scale scores', 'postoperative nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C4552199', 'cui_str': 'Systemic toxicity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]",40.0,0.0579249,Pain visual analog scale scores were significantly lower at both 6 and 24 h postoperatively in TAP group when compared with the no-TAP group.,"[{'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdelsalam', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Ain Shams University, Cairo, Egypt; Department of Anesthesia, Faculty of Medicine, King Fahd Specialist Hospital, Dammam, Saudi Arabia.'}, {'ForeName': 'O W', 'Initials': 'OW', 'LastName': 'Mohamdin', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, King Fahd Specialist Hospital, Dammam, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169470']
1942,26955308,"Enhancing needle visualization during parasagittal approach in paravertebral block for patients undergoing simple mastectomy using in-plane, multiangle ultrasound needle guidance system.","BACKGROUND
Ultrasound-guided paravertebral blocks during breast surgeries with in-plane needle approaches can be challenging due to difficult needle visualization. The purpose of this study was to assess the usefulness of using a needle guide while performing in-plane parasagittal approach paravertebral block for breast surgery.
PATIENTS AND METHODS
Eighty patients, American Society of Anesthesiologists physical status I-III, aged 20-40 years with breast mass scheduled for simple mastectomy surgery, were involved in prospective, controlled, randomized study, and were randomly divided by closed envelope method into two groups: Group I (n = 40): Scheduled for ultrasound-guided paravertebral block or group II (n = 40): Scheduled for ultrasound-guided paravertebral block using the needle guide. Both techniques compared as regards: (i) Needle visibility and block performance time; (ii) number of needle passes; (iii) duration of the block; (iv) doctor and patient satisfaction; and (v) incidence of complications.
RESULTS
Needle visibility score was better in group II (2.92 ± 0.26 vs. 1.9 ± 0.44, P < 0.0001). Block performance time was shorter in group II (90.92 ± 15 vs. 128.25 ± 16s, P < 0.0001). A number of needle passes were less in group II (1.27 ± 0.45 vs. 2.2 ± 0.68, P < 0.0001). Doctor and patient satisfaction were better in group II (P = 0.015). No differences were found regarding the duration of the block and incidence of complications between groups.
CONCLUSION
A needle guide can help reduce the time needed to perform a parasagittal in-plane thoracic paravertebral block, with a significant reduction in the block performance time, the number of needle passes, better needle visibility and better doctor and patient's satisfaction. However, there was no significant difference regarding the duration of the block or incidence of complications.",2016,"Block performance time was shorter in group II (90.92 ± 15 vs. 128.25 ± 16s, P < 0.0001).","['patients undergoing simple mastectomy using in-plane, multiangle ultrasound needle guidance system', 'Eighty patients, American Society of Anesthesiologists physical status I-III, aged 20-40 years with breast mass scheduled for simple mastectomy surgery']","['ultrasound-guided paravertebral block or group II (n = 40): Scheduled for ultrasound-guided paravertebral block using the needle guide', 'needle guide while performing in-plane parasagittal approach paravertebral block']","['Doctor and patient satisfaction', 'Needle visibility score', 'Block performance time', 'number of needle passes', 'Needle visibility and block performance time; (ii) number of needle passes; (iii) duration of the block; (iv) doctor and patient satisfaction; and (v) incidence of complications', 'duration of the block or incidence of complications', 'duration of the block and incidence of complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024103', 'cui_str': 'Breast lump (finding)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0181951', 'cui_str': 'Needle guide, device (physical object)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0522491', 'cui_str': 'Parasagittal (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",80.0,0.0281389,"Block performance time was shorter in group II (90.92 ± 15 vs. 128.25 ± 16s, P < 0.0001).","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Kasr Al-Ainy Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Sonbaty', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Kasr Al-Ainy Hospital, Cairo University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169472']
1943,26952175,Dexmedetomidine as an additive to local anesthetics compared with intravenous dexmedetomidine in peribulbar block for cataract surgery.,"BACKGROUND
No studies compared parenteral dexmedetomidine with its use as an adjuvant to ophthalmic block. We compared between adding dexmedetomidine to bupivacaine in peribulbar block and intravenous (IV) dexmedetomidine during peribulbar block for cataract surgery.
MATERIALS AND METHODS
A prospective, randomized, double-blind study on 90 patients for cataract surgery under peribulbar anesthesia. Study included three groups; all patients received 10 ml of peribulbar anesthesia and IV infusion of drugs as follows: Group I: Received a mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + normal saline (1 ml) + 150 IU hyaluronidase + IV infusion of normal saline, Group II: Received mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) +150 IU hyaluronidase + IV infusion of normal saline and Group III: Received mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + normal saline (1 ml) +150 IU hyaluronidase + IV dexmedetomidine 1 μg/kg over 10 min; followed by 0.4 μg/kg/h IV infusion. We recorded onset, duration of block, Ramsay Sedation Score, intra-ocular pressure (IOP), hemodynamics, and adverse effects.
RESULTS
There was a significant decrease in the onset of action and increase in the duration of block in Group II as compared with the Group I and Group III. Mean Ramsay Sedation Score was higher in Group III. The IOP showed a significant decrease in Group II and Group III 10 min after injection (P < 0.01). Heart rate showed a significant decrease in Group III in comparison with the two other groups (P < 0.05). Only two patients in Group III developed bradycardia.
CONCLUSION
Dexmedetomidine as an additive shortens onset time, prolong block durations and significantly decreases the IOP with minimal side effects. IV dexmedetomidine, in addition, produces intra-operative sedation with hemodynamic stability.",2016,The IOP showed a significant decrease in Group II and Group III,"['90 patients for cataract surgery under peribulbar anesthesia', 'peribulbar block for cataract surgery']","['Dexmedetomidine', 'dexmedetomidine', 'mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) +150 IU hyaluronidase + IV infusion of normal saline and Group III: Received mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + normal saline (1 ml) +150 IU hyaluronidase + IV dexmedetomidine', 'parenteral dexmedetomidine', 'bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + normal saline (1 ml) + 150 IU hyaluronidase + IV infusion of normal saline', 'IV dexmedetomidine', 'bupivacaine', 'peribulbar anesthesia and IV infusion of drugs as follows', 'intravenous (IV) dexmedetomidine']","['block durations', 'Heart rate', 'onset of action', 'Mean Ramsay Sedation Score', 'duration of block', 'duration of block, Ramsay Sedation Score, intra-ocular pressure (IOP), hemodynamics, and adverse effects', 'bradycardia', 'IOP with minimal side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0583006', 'cui_str': 'Peribulbar block'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]",90.0,0.330306,The IOP showed a significant decrease in Group II and Group III,"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Aaa', 'Initials': 'A', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Beni Suef University, Beni Suef, Egypt.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Abdelhaq', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Yasin', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Al Fayoum University, Faiyum, Egypt.'}, {'ForeName': 'Asm', 'Initials': 'A', 'LastName': 'Bayoumi', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Benha University, Benha, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169475']
1944,32107609,Ramucirumab after prior sorafenib in patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein: Japanese subgroup analysis of the REACH-2 trial.,"BACKGROUND
The global, randomized, phase 3 REACH-2 study (ClinicalTrials.gov identifier: NCT02435433) found significantly longer overall survival (OS) for second-line ramucirumab versus placebo (hazard ratio [HR]: 0.710, 95% confidence interval [CI] 0.531-0.949, P = 0.0199) in patients with advanced hepatocellular carcinoma (HCC) and alpha-fetoprotein (AFP) ≥ 400 ng/mL. This prespecified subgroup analysis evaluated the efficacy and safety of ramucirumab in the Japanese patients enrolled in the study.
METHODS
Patients with advanced HCC and AFP ≥ 400 ng/mL after first-line sorafenib were randomized 2:1 to ramucirumab (8 mg/kg intravenously) or placebo every 2 weeks. Hazard ratios for progression-free survival (PFS) and OS (primary endpoint of the overall study) were estimated using the stratified Cox regression model. We also pooled individual patient data from REACH-2 with data from REACH (NCT01140347) for patients with AFP ≥ 400 ng/mL.
RESULTS
In the Japanese REACH-2 subpopulation, there were improvements for ramucirumab (n = 41) versus placebo (n = 18) in PFS (HR 0.282, 95% CI 0.144-0.553) and OS was numerically prolonged (HR 0.599, 95% CI 0.303-1.187), consistent with the significant benefit seen in the overall REACH-2 study population. In the ramucirumab and placebo arms, respectively, the objective response rate was 7.3% and 0%, and the disease control rate was 70.7% and 33.3%. The most frequently reported grade ≥ 3 treatment-emergent adverse event was hypertension (ramucirumab: 15%; placebo: 11%).
CONCLUSIONS
Ramucirumab after prior sorafenib improved PFS and OS compared with placebo, with a manageable safety profile, in the Japanese REACH-2 subpopulation, consistent with the overall REACH-2 study results. Ramucirumab is the first agent to demonstrate clinical benefit for Japanese patients with HCC in the second-line setting.",2020,"In the Japanese REACH-2 subpopulation, there were improvements for ramucirumab (n = 41) versus placebo (n = 18) in PFS (HR 0.282, 95% CI 0.144-0.553) and OS was numerically prolonged (HR 0.599, 95% CI 0.303-1.187), consistent with the significant benefit seen in the overall REACH-2 study population.","['patients with advanced hepatocellular carcinoma (HCC) and alpha-fetoprotein (AFP)\u2009≥\u2009400', 'patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein', 'Japanese patients enrolled in the study', 'Patients with advanced HCC and AFP\u2009≥', 'patients with AFP\u2009≥\u2009400', 'Japanese patients with HCC in the second-line setting']","['placebo', 'Ramucirumab', 'ramucirumab', 'Ramucirumab after prior sorafenib']","['objective response rate', 'efficacy and safety', 'overall survival (OS', 'Hazard ratios for progression-free survival (PFS) and OS', 'disease control rate', 'PFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0002210', 'cui_str': 'alpha-Fetoproteins'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.561281,"In the Japanese REACH-2 subpopulation, there were improvements for ramucirumab (n = 41) versus placebo (n = 18) in PFS (HR 0.282, 95% CI 0.144-0.553) and OS was numerically prolonged (HR 0.599, 95% CI 0.303-1.187), consistent with the significant benefit seen in the overall REACH-2 study population.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan. m-kudo@med.kindai.ac.jp.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Aso Iizuka Hospital, Fukuoka, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Ohno', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Kyoundo Hospital, Sasaki Institute, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Graduate School of Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Furukawa', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Aramaki', 'Affiliation': 'Shizuoka Cancer Center Hospital, Shizuoka, Japan.'}, {'ForeName': 'Seijin', 'Initials': 'S', 'LastName': 'Nadano', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Ohkawa', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Kudo', 'Affiliation': 'Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Takai', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Gosuke', 'Initials': 'G', 'LastName': 'Homma', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Reigetsu', 'Initials': 'R', 'LastName': 'Yoshikawa', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}]",Journal of gastroenterology,['10.1007/s00535-020-01668-w']
1945,31553468,Association of Short-term Change in Leukocyte Telomere Length With Cortical Thickness and Outcomes of Mental Training Among Healthy Adults: A Randomized Clinical Trial.,"Importance
Telomere length is associated with the development of age-related diseases and structural differences in multiple brain regions. It remains unclear, however, whether change in telomere length is linked to brain structure change, and to what extent telomere length can be influenced through mental training.
Objectives
To assess the dynamic associations between leukocyte telomere length (LTL) and cortical thickness (CT), and to determine whether LTL is affected by a longitudinal contemplative mental training intervention.
Design, Setting, and Participants
An open-label efficacy trial of three 3-month mental training modules with healthy, meditation-naive adults was conducted. Data on LTL and CT were collected 4 times over 9 months between April 22, 2013, and March 31, 2015, as part of the ReSource Project. Data analysis was performed between September 23, 2016, and June 21, 2019. Of 1582 eligible individuals, 943 declined to participate; 362 were randomly selected for participation and assigned to training or retest control cohorts, with demographic characteristics matched. The retest control cohorts underwent all testing but no training. Intention-to-treat analysis was performed.
Interventions
Training cohort participants completed 3 modules cultivating interoception and attention (Presence), compassion (Affect), or perspective taking (Perspective).
Main Outcomes and Measures
Change in LTL and CT.
Results
Of the 362 individuals randomized, 30 participants dropped out before study initiation (initial sample, 332). Data were available for analysis of the training intervention in 298 participants (n = 222 training; n = 76 retest control) (175 women [58.7%]; mean [SD] age, 40.5 [9.3] years). The training modules had no effect on LTL. In 699 observations from all 298 participants, mean estimated changes in the relative ratios of telomere repeat copy number to single-copy gene (T/S) were for no training, 0.004 (95% CI, -0.010 to 0.018); Presence, -0.007 (95% CI, -0.025 to 0.011); Affect, -0.005 (95% CI, -0.019 to 0.010); and Perspective, -0.001 (95% CI, -0.017 to 0.016). Cortical thickness change data were analyzed in 167 observations from 67 retest control participants (37 women [55.2%], mean [SD] age, 39.6 [9.0] years). In this retest control cohort subsample, naturally occurring LTL change was related to CT change in the left precuneus extending to the posterior cingulate cortex (mean t161 = 3.22; P < .001; r = 0.246). At the individual participant level, leukocyte telomere shortening as well as lengthening were observed. Leukocyte telomere shortening was related to cortical thinning (t77 = 2.38; P = .01; r = 0.262), and leukocyte telomere lengthening was related to cortical thickening (t77 = 2.42; P = .009; r = 0.266). All analyses controlled for age, sex, and body mass index.
Conclusions and Relevance
The findings of this trial indicate an association between short-term change in LTL and concomitant change in plasticity of the left precuneus extending to the posterior cingulate cortex. This result contributes to the evidence that LTL changes more dynamically on the individual level than previously thought. Further studies are needed to determine potential long-term implications of such change in relation to cellular aging and the development of neurodegenerative disorders. No effect of contemplative mental training was noted in what may be, to date, the longest intervention with healthy adults.
Trial Registration
ClinicalTrials.gov identifier: NCT01833104.",2019,"Leukocyte telomere shortening was related to cortical thinning (t77 = 2.38; P = .01; r = 0.262), and leukocyte telomere lengthening was related to cortical thickening (t77 = 2.42; P = .009; r = 0.266).","['Healthy Adults', 'with healthy, meditation-naive adults', '167 observations from 67 retest control participants (37 women [55.2', '1582 eligible individuals, 943 declined to participate; 362 were randomly selected for participation and assigned to training or retest control cohorts, with demographic characteristics matched', 'healthy adults', '298 participants (n\u2009=\u2009222 training; n\u2009=\u200976 retest control) (175 women [58.7%]; mean [SD] age, 40.5 [9.3] years', '30 participants dropped out before study initiation (initial sample, 332', '362 individuals randomized']","['mental training modules', 'contemplative mental training', 'Mental Training', 'Interventions\n\n\nTraining cohort participants completed 3 modules cultivating interoception and attention (Presence), compassion (Affect), or perspective taking (Perspective']","['LTL', 'leukocyte telomere length (LTL) and cortical thickness (CT', 'Measures\n\n\nChange in LTL and CT', 'relative ratios of telomere repeat copy number to single-copy gene (T/S', 'Cortical thickness change data', 'Leukocyte Telomere']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0150277'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3850156', 'cui_str': 'Interoception'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1264683', 'cui_str': 'Relative ratio'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",298.0,0.0716763,"Leukocyte telomere shortening was related to cortical thinning (t77 = 2.38; P = .01; r = 0.262), and leukocyte telomere lengthening was related to cortical thickening (t77 = 2.42; P = .009; r = 0.266).","[{'ForeName': 'Lara M C', 'Initials': 'LMC', 'LastName': 'Puhlmann', 'Affiliation': 'Research Group, ""Social Stress and Family Health,"" Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Sofie L', 'Initials': 'SL', 'LastName': 'Valk', 'Affiliation': 'Institute of Systems Neuroscience, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Engert', 'Affiliation': 'Research Group, ""Social Stress and Family Health,"" Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Boris C', 'Initials': 'BC', 'LastName': 'Bernhardt', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Biochemistry and Biophysics, University of California, San Francisco.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vrticka', 'Affiliation': 'Research Group, ""Social Stress and Family Health,"" Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Singer', 'Affiliation': 'Social Neuroscience Lab, Max Planck Society, Berlin, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9687']
1946,31553469,Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial.,"Importance
Owing to biological, behavioral, and societal factors, sleep duration in teenagers is often severely truncated, leading to pervasive sleep deprivation.
Objective
To determine whether a novel intervention, using both light exposure during sleep and cognitive behavioral therapy (CBT), would increase total sleep time in teenagers by enabling them to go to sleep earlier than usual.
Design, Setting, and Participants
This double-blind, placebo-controlled, randomized clinical trial, conducted between November 1, 2013, and May 31, 2016, among 102 adolescents enrolled full-time in grades 9 to 12, who expressed difficulty going to bed earlier and waking up early enough, was composed of 2 phases. In phase 1, participants were assigned to receive either 3 weeks of light or sham therapy and were asked to try to go to sleep earlier. In phase 2, participants received 4 brief CBT sessions in addition to a modified light or sham therapy. All analyses were performed on an intent-to-treat basis.
Interventions
Light therapy consisted of receiving a 3-millisecond light flash every 20 seconds during the final 3 hours of sleep (phase 1) or final 2 hours of sleep (phase 2). Sham therapy used an identical device, but delivered 1 minute of light pulses (appearing in 20-second intervals, for a total of 3 pulses) per hour during the final 3 hours of sleep (phase 1) or 2 hours of sleep (phase 2). Light therapy occurred every night during the 4-week intervention. Cognitive behavioral therapy consisted of four 50-minute in-person sessions once per week.
Main Outcomes and Measures
Primary outcome measures included diary-based sleep times, momentary ratings of evening sleepiness, and subjective measures of sleepiness and sleep quality.
Results
Among the 102 participants (54 female [52.9%]; mean [SD] age, 15.6 [1.1] years), 72 were enrolled in phase 1 and 30 were enrolled in phase 2. Mixed-effects models revealed that light therapy alone was inadequate in changing the timing of sleep. However, compared with sham therapy plus CBT alone, light therapy plus CBT significantly moved sleep onset a mean (SD) of 50.1 (27.5) minutes earlier and increased nightly total sleep time by a mean (SD) of 43.3 (35.0) minutes. Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale.
Conclusions and Relevance
This study found that light exposure during sleep, in combination with a brief, motivation-focused CBT intervention, was able to consistently move bedtimes earlier and increase total sleep time in teenagers. This type of passive light intervention in teenagers may lead to novel therapeutic applications.
Trial Registration
ClinicalTrials.gov identifier: NCT01406691.",2019,"Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale.
","['teenagers', 'Adolescents', 'November 1, 2013, and May 31, 2016, among 102 adolescents enrolled full-time in grades 9 to 12, who expressed difficulty going to bed earlier and waking up early enough, was composed of 2 phases', '102 participants (54 female [52.9%]; mean [SD] age, 15.6 [1.1] years), 72 were enrolled in phase 1 and 30 were enrolled in phase 2', 'teenagers by enabling them to go to sleep earlier than usual']","['4 brief CBT sessions in addition to a modified light or sham therapy', 'light therapy', 'Light therapy plus CBT', 'CBT intervention', 'light or sham therapy', 'light exposure during sleep and cognitive behavioral therapy (CBT', 'Adjunct Cognitive Behavioral Therapy', 'placebo', 'Cognitive behavioral therapy', 'Light Flashes vs Sham Therapy', 'Light therapy', 'passive light intervention']","['total sleep time', 'subjective evening sleepiness', 'Sleep Quality', 'diary-based sleep times, momentary ratings of evening sleepiness, and subjective measures of sleepiness and sleep quality', 'nightly total sleep time', '7-point sleepiness scale', 'bedtime compliance']","[{'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085635', 'cui_str': 'Photopsia (disorder)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",102.0,0.0521975,"Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale.
","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Kaplan', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Meital', 'Initials': 'M', 'LastName': 'Mashash', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Rayma', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Batchelder', 'Affiliation': 'Palo Alto University, Palo Alto, California.'}, {'ForeName': 'Lolly', 'Initials': 'L', 'LastName': 'Starr-Glass', 'Affiliation': 'Palo Alto University, Palo Alto, California.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zeitzer', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11944']
1947,26955309,Comparison of effects of ropivacaine with and without dexmedetomidine in axillary brachial plexus block: A prospective randomized double-blinded clinical trial.,"BACKGROUND
Addition of dexmedetomidine to ropivacaine for peripheral nerve blocks has shown to improve the efficacy of ropivacaine by prolonging the duration of analgesia. This study was undertaken to evaluate the effects of ropivacaine alone and in combination with dexmedetomidine in the axillary block.
MATERIALS AND METHODS
A total of 80 patients belonging to American Society of Anesthesiologists physical status I, II, and III, scheduled for elective forearm and/or hand surgeries were randomly allocated into one of the two groups to receive either 39 ml of 0.375% ropivacaine and 1 ml normal saline (Group R) or 39 ml of 0.375% ropivacaine and 1 μg/kg dexmedetomidine diluted to 1 ml with normal saline (Group RD).
RESULTS
There was a significant early the onset of sensory and the motor block in Group RD. Duration of sensory block in Group RD was 677.25 ± 99.64 min and in Group R was 494.38 ± 70.64 min and the difference was clinically significant (P < 0.001). Duration of motor block in Group RD was 712.88 ± 89.32 min and in Group R was 526.25 ± 70.229 min and was clinically significant. Duration of analgesia in Group RD was 764.38 ± 110.275 min and that in Group R was 576.88 ± 76.306 min and was clinically significant. There was a significant alteration in hemodynamics in Group RD when compared to Group R without any side effects.
CONCLUSION
Dexmedetomidine as an adjuvant to ropivacaine provides quicker onset of anesthesia, longer duration of analgesia. It offers convenient, simple, effective mode of anesthesia, and postoperative analgesia for forearm and/or hand surgeries.",2016,"There was a significant alteration in hemodynamics in Group RD when compared to Group R without any side effects.
","['80 patients belonging to American Society of Anesthesiologists physical status I, II, and III, scheduled for elective forearm and/or hand surgeries', 'axillary brachial plexus block']","['Dexmedetomidine', '39 ml of 0.375% ropivacaine and 1 ml normal saline (Group R) or 39 ml of 0.375% ropivacaine and 1 μg/kg dexmedetomidine diluted to 1 ml with normal saline', 'ropivacaine with and without dexmedetomidine', 'ropivacaine', 'dexmedetomidine']","['onset of sensory and the motor block', 'Duration of analgesia', 'hemodynamics', 'Duration of motor block', 'Duration of sensory block']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0394701', 'cui_str': 'Brachial plexus block by axillary approach (procedure)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4517455', 'cui_str': '0.375 (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441852', 'cui_str': 'Group R (qualifier value)'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",80.0,0.141335,"There was a significant alteration in hemodynamics in Group RD when compared to Group R without any side effects.
","[{'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Bangera', 'Affiliation': 'Department of Anesthesia, K S Hegde Medical Academy, Nitte University, Mangalore, Karnataka, India.'}, {'ForeName': 'Mukka', 'Initials': 'M', 'LastName': 'Manasa', 'Affiliation': 'Department of Anesthesia, K S Hegde Medical Academy, Nitte University, Mangalore, Karnataka, India.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Krishna', 'Affiliation': 'Department of Anesthesia, K S Hegde Medical Academy, Nitte University, Mangalore, Karnataka, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169473']
1948,26955312,Effect of preoperative flupirtine on postoperative morphine sparing in patients undergoing total abdominal hysterectomy.,"BACKGROUND
Flupirtine is a unique non-opioid, centrally acting analgesic with muscle relaxant properties. So far no study has evaluated, use of preoperative flupirtine on postoperative morphine sparing effect in patients undergoing total abdominal hysterectomy (TAH).
MATERIALS AND METHODS
We performed a prospective, controlled, and randomized study in 50 female patients of American Society of Anesthesiologists physical status I-II, aged between 30 and 60 years scheduled for TAH under general anesthesia (GA). Patients were randomized to receive either single dose flupirtine 100 mg or placebo 1 h prior to surgery. A standard anesthetic and analgesic protocol was followed in both the groups. Postoperatively, a titrated loading dose of intravenous morphine 0.1 mg/kg was followed with patient-controlled analgesia with morphine (bolus of 0.01 mg/kg with a lockout time of 7 min). The primary outcome was cumulative morphine consumption at 48 h postoperatively. Secondary outcomes included hemodynamics, visual analog scale (VAS) at rest, VAS on cough, and any adverse effects.
RESULTS
All enrolled 50 patients completed the follow-up. The cumulative mean morphine consumption (standard deviation [SD]) at 48 h (40.4 [6.0] vs. 47 [6.6] mg, P = 0.001) was reduced in-group flupirtine as compared with placebo. The cumulative mean VAS at rest (SD) (3 [0.7] vs. 3.7 [0.7], P = 0.001) and on cough (3 [0.9] vs. 3.8 [0.5], P = 0.002) were reduced in-group flupirtine as compared with placebo at 48 h postoperatively.
CONCLUSION
Preoperative use of flupirtine exhibited morphine sparing effect in patients following TAH under GA at 48 h.",2016,"CONCLUSION
Preoperative use of flupirtine exhibited morphine sparing effect in patients following TAH under GA at 48 h.","['patients undergoing total abdominal hysterectomy (TAH', '50 female patients of American Society of Anesthesiologists physical status I-II, aged between 30 and 60 years scheduled for TAH under general anesthesia (GA', 'patients following TAH under GA at 48 h', 'patients undergoing total abdominal hysterectomy']","['preoperative flupirtine', 'morphine 0.1 mg/kg was followed with patient-controlled analgesia with morphine', 'placebo', 'flupirtine 100 mg or placebo']","['cumulative mean morphine consumption', 'cumulative morphine consumption', 'cumulative mean VAS at rest (SD', 'cough', 'hemodynamics, visual analog scale (VAS) at rest, VAS on cough, and any adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0060583', 'cui_str': 'flupirtine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",50.0,0.321365,"CONCLUSION
Preoperative use of flupirtine exhibited morphine sparing effect in patients following TAH under GA at 48 h.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thapa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ahuja', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dass', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gombar', 'Affiliation': 'Department of Anesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Huria', 'Affiliation': 'Department of Obstetrics and Gynecology, Government Medical College and Hospital, Chandigarh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169477']
1949,26955313,Effect of addition of magnesium to local anesthetics for peribulbar block: A prospective randomized double-blind study.,"BACKGROUND
Magnesium sulphate has been used along with local anesthetics in different regional blocks and found to be effective in decreasing the time of onset of the block and increasing the duration of the block.
OBJECTIVE
To evaluate the effect of addition of magnesium sulfate to standard local anesthetics mixture on the time for onset of the globe and lid akinesia for peribulbar block in ophthalmic surgeries.
MATERIALS AND METHODS
Sixty patients with American Society of Anesthesiologists status I to III undergoing ophthalmic surgery under peribulbar block were included in this study. Patients were randomized into two groups. Both the groups received 4.5 ml of 2% lidocaine, 4.5 ml of 0.5% bupivacaine with150 IU hyaluronidase. Group NS received normal saline 1 ml in the peribulbar block and Group MS, magnesium sulfate 50 mg in 1 ml normal saline. The onset of akinesia, satisfactory block and complications were observed by an independent observer.
RESULTS
Demographic data was statistically similar. In the Group NS at 3, 5, 10 and 15 min after the block, complete akinesia was seen in 0, 2, 11 and 28 patients respectively. In the Group MS, at 3, 5, 10 and 15 min after the block, complete akinesia was seen in 13, 23, 27 and 28 patients respectively. Patients received magnesium sulfate showed the statistically significant rapid onset of lid and globe akinesia than the control group till 10 min (P < 0.000). None of the patients needed a supplementary block and had complications during the surgery.
CONCLUSION
Addition of 50 mg of magnesium sulfate to the lidocaine-bupivacaine mixture for peribulbar block decreases the onset of akinesia without any obvious side effect.",2016,"In the Group NS at 3, 5, 10 and 15 min after the block, complete akinesia was seen in 0, 2, 11 and 28 patients respectively.","['peribulbar block', 'Sixty patients with American Society of Anesthesiologists status I to III undergoing ophthalmic surgery under peribulbar block']","['bupivacaine with150 IU hyaluronidase', 'magnesium sulfate', 'Magnesium sulphate', 'lidocaine', 'normal saline 1 ml in the peribulbar block and Group MS, magnesium sulfate 50 mg in 1 ml normal saline', 'lidocaine-bupivacaine mixture', 'magnesium to local anesthetics']","['rapid onset of lid and globe akinesia', 'onset of akinesia without any obvious side effect', 'onset of akinesia, satisfactory block and complications', 'complete akinesia']","[{'cui': 'C0583006', 'cui_str': 'Peribulbar block'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0583006', 'cui_str': 'Peribulbar block'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0085623', 'cui_str': 'Akinesia (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",60.0,0.317305,"In the Group NS at 3, 5, 10 and 15 min after the block, complete akinesia was seen in 0, 2, 11 and 28 patients respectively.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Ray', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chandiran', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chandralekha', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Ophthalmology, All India Institute of Medical Sciences, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169478']
1950,30887611,"Letter to the Editor regarding the paper ""Cardioversion of atrial fibrillation in obese patients: Results from the Cardioversion-BMI randomized controlled trial"".",,2019,,['obese patients'],[],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.0539849,,"[{'ForeName': 'F Daniel', 'Initials': 'FD', 'LastName': 'Ramirez', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Mouhannad M', 'Initials': 'MM', 'LastName': 'Sadek', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Birnie', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13910']
1951,26941086,Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.,"BACKGROUND
The combination of prophylactic pancreatic stent placement (PSP) - a temporary plastic stent placed in the pancreatic duct - and rectal non-steroidal anti-inflammatory drugs (NSAIDs) is recommended for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Preliminary data, however, suggest that PSP may be unnecessary if rectal NSAIDs are administered. Given the costs and potential risks of PSP, we aim to determine whether rectal indomethacin obviates the need for pancreatic stent placement in patients undergoing high-risk ERCP.
METHODS/DESIGN
The SVI (Stent vs. Indomethacin) trial is a comparative effectiveness, multicenter, randomized, double-blind, non-inferiority study of rectal indomethacin alone versus the combination of rectal indomethacin and PSP for preventing PEP in high-risk cases. One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention, will be randomized to indomethacin alone or combination therapy. Those who are aware of study group assignment, including the endoscopist, will not be involved in the post-procedure care of the patient for at least 48 hours. Subjects will be assessed for PEP and its severity by a panel of independent and blinded adjudicators. Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups. Biological specimens will be obtained from trial participants and centrally banked.
DISCUSSION
The SVI trial is designed to determine whether PSP remains necessary in the era of NSAIDs pharmacoprevention. The associated bio-repository will establish the groundwork for important scientific breakthrough.
TRIAL REGISTRATION
NCT02476279, registered June 2015.",2016,Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups.,"['patients undergoing high-risk ERCP', 'high-risk cases', 'One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention']","['rectal indomethacin and PSP', 'SVI (Stent vs. Indomethacin', 'indomethacin alone or combination therapy', 'Rectal indomethacin', 'indomethacin and prophylactic pancreatic stent placement', 'Indomethacin', 'prophylactic pancreatic stent placement (PSP) - a temporary plastic stent placed', 'PSP', 'rectal indomethacin']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C2747855', 'cui_str': 'Pancreatic stent placement'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent (physical object)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]",[],1430.0,0.326371,Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups.,"[{'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. elmunzer@musc.edu.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA. SerranoJ@extra.niddk.nih.gov.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA. Amitabh.Chak@uhhospitals.org.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Edmundowicz', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA. SEdmundo@dom.wustl.edu.'}, {'ForeName': 'Georgios I', 'Initials': 'GI', 'LastName': 'Papachristou', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. papachri@pitt.edu.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Scheiman', 'Affiliation': 'Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA. jscheima@med.umich.edu.'}, {'ForeName': 'Vikesh K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA. vsingh1@jhmi.edu.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadurajulu', 'Affiliation': 'Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA. svaradarajulu@yahoo.com.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Vargo', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA. Vargoj@ccf.org.'}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': 'Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA. field.willingham@emoryhealthcare.org.'}, {'ForeName': 'Todd H', 'Initials': 'TH', 'LastName': 'Baron', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. todd_baron@med.unc.edu.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Coté', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. cotea@musc.edu.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Romagnuolo', 'Affiliation': 'Tidelands Health, Murrels Inlet, SC, USA. romagnuoloj@gmail.com.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Wood-Williams', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. woodap@musc.edu.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Depue', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. depue@musc.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. spitzer@musc.edu.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA. spino@med.umich.edu.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. fosterl@musc.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. durkalsv@musc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-016-1251-2']
1952,32416780,"Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial.","BACKGROUND
Atezolizumab can induce sustained responses in metastatic urothelial carcinoma. We report the results of IMvigor130, a phase 3 trial that compared atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in first-line metastatic urothelial carcinoma.
METHODS
In this multicentre, phase 3, randomised trial, untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries, were randomly assigned to receive atezolizumab plus platinum-based chemotherapy (group A), atezolizumab monotherapy (group B), or placebo plus platinum-based chemotherapy (group C). Patients received 21-day cycles of gemcitabine (1000 mg/m 2 body surface area, administered intravenously on days 1 and 8 of each cycle), plus either carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin (70 mg/m 2 body surface area administered intravenously) on day 1 of each cycle with either atezolizumab (1200 mg administered intravenously on day 1 of each cycle) or placebo. Group B patients received 1200 mg atezolizumab, administered intravenously on day 1 of each 21-day cycle. The co-primary efficacy endpoints for the intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival (group A vs group C) and overall survival (group B vs group C), which was to be formally tested only if overall survival was positive for group A versus group C. The trial is registered with ClinicalTrials.gov, NCT02807636.
FINDINGS
Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients. 451 (37%) were randomly assigned to group A, 362 (30%) to group B, and 400 (33%) to group C. Median follow-up for survival was 11·8 months (IQR 6·1-17·2) for all patients. At the time of final progression-free survival analysis and interim overall survival analysis (May 31, 2019), median progression-free survival in the intention-to-treat population was 8·2 months (95% CI 6·5-8·3) in group A and 6·3 months (6·2-7·0) in group C (stratified hazard ratio [HR] 0·82, 95% CI 0·70-0·96; one-sided p=0·007). Median overall survival was 16·0 months (13·9-18·9) in group A and 13·4 months (12·0-15·2) in group C (0·83, 0·69-1·00; one-sided p=0·027). Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24). Adverse events that led to withdrawal of any agent occurred in 156 (34%) patients in group A, 22 (6%) patients in group B, and 132 (34%) patients in group C. 50 (11%) patients in group A, 21 (6%) patients in group B, and 27 (7%) patients in group C had adverse events that led to discontinuation of atezolizumab or placebo.
INTERPRETATION
Addition of atezolizumab to platinum-based chemotherapy as first-line treatment prolonged progression-free survival in patients with metastatic urothelial carcinoma. The safety profile of the combination was consistent with that observed with the individual agents. These results support the use of atezolizumab plus platinum-based chemotherapy as a potential first-line treatment option for metastatic urothelial carcinoma.
FUNDING
F Hoffmann-La Roche and Genentech.",2020,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","['0·82', 'patients with metastatic urothelial carcinoma', 'Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients', 'metastatic urothelial cancer (IMvigor130', 'first-line metastatic urothelial carcinoma', 'untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries', 'metastatic urothelial carcinoma']","['atezolizumab to platinum-based chemotherapy', 'carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin', 'Atezolizumab', 'atezolizumab', 'atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy', 'IMvigor130', 'atezolizumab plus platinum-based chemotherapy', 'gemcitabine', 'placebo plus platinum-based chemotherapy', 'Atezolizumab with or without chemotherapy', 'atezolizumab monotherapy', 'placebo']","['Median overall survival', 'median progression-free survival', 'Adverse events', 'overall survival', 'time of final progression-free survival analysis and interim overall survival analysis', 'intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517491', 'cui_str': '1.1'}]",1213.0,0.469836,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY, USA. Electronic address: matthew.galsky@mssm.edu.'}, {'ForeName': 'José Ángel Arranz', 'Initials': 'JÁA', 'LastName': 'Arija', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Eastern Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'De Santis', 'Affiliation': 'Charité University Hospital, Berlin, Germany; Department of Urology, Medical University, Vienna, Austria.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kikuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Garcia-Del-Muro', 'Affiliation': 'Catalan Institute of Oncology, IDIBELL, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mencinger', 'Affiliation': 'Institute of Oncology Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Panni', 'Affiliation': 'Istituti Ospitalieri Cremona, Cremona, Italy.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gumus', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Arash Rezazadeh', 'Initials': 'AR', 'LastName': 'Kalebasty', 'Affiliation': 'Norton Cancer Institute, Louisville, KY, USA.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'P Herzen Oncology Research Institute, Moscow, Russia.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Schutz', 'Affiliation': 'Beneficencia Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jian-Ri', 'Initials': 'JR', 'LastName': 'Li', 'Affiliation': 'Taichung Veterans General Hospital, HungKuang University, Taichung, Taiwan.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Bernhard', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Tayama', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Mecke', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'AnnChristine', 'Initials': 'A', 'LastName': 'Thåström', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'MD Anderson Cancer Center Madrid, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30230-0']
1953,32419303,"Influence of Clinical, Physical, Psychological, and Psychophysical Variables on Treatment Outcomes in Somatic Tinnitus Associated With Temporomandibular Pain: Evidence From a Randomized Clinical Trial.","OBJECTIVE
To assess the influence of clinical, psychological, and psychophysical variables on treatment outcomes after application of exercise combined with education with/without manual therapy in people with tinnitus associated with temporomandibular disorder (TMD).
METHODS
A secondary analysis of a clinical trial was performed investigating the effectiveness of including cervico-mandibular manual therapy into an exercise combined with education program in 61 subjects with TMD-related tinnitus. Clinical outcomes including tinnitus severity and tinnitus-related handicap were assessed at 3 and 6 months post-intervention. Patients were assessed at baseline for clinical (tinnitus severity, tinnitus-related handicap, quality of life), physical (range of motion), psychological (depression), and psychophysical (pressure pain thresholds [PPTs]) variables that were included as predictors.
RESULTS
The regression models indicated that higher scores of tinnitus severity at baseline predicted better outcomes 3 and 6 months post-intervention (explaining 13% to 41% of the variance) in both groups. Higher scores of tinnitus-related handicap at baseline predicted better outcome of tinnitus-related handicap (45% variance) in the manual therapy with exercise/education group. Lower PPTs over the temporalis muscle at baseline predicted poorer clinical outcomes (10.5% to 41% of the variance) in both groups. Other predictors were sex and quality of life (6.7% variance) in the manual therapy group and PPTs over the masseter muscle (5.8% variance) in the exercise/education group.
CONCLUSION
This study found that baseline tinnitus severity and localized PPT over the temporalis muscle were predictive of clinical outcomes in individuals with TMD-related tinnitus following physical therapy. Other predictors (eg, sex, quality of life) were less influential.",2020,Higher scores of related-handicap at baseline predicted better outcome of tinnitus handicap (45% variance) in the manual therapy with exercise/education group.,"['Somatic Tinnitus associated to Temporomandibular Pain', '61 subjects with TMD-related tinnitus was performed', 'individuals with TMD-related tinnitus following physical therapy', 'people with tinnitus associated to TMD']","['cervico-mandibular manual therapy into an exercise combined with education program', 'exercise combined with education with/without manual therapy']","['sex and quality of life', 'clinical outcomes', 'tinnitus severity and related-handicap', 'Higher scores of related-handicap', 'baseline clinical (severity, handicap, quality of life), physical (range of motion), psychological (depression), and psychophysical (pressure pain thresholds, PPTs) variables', 'sex, quality of life', 'tinnitus severity', 'tinnitus handicap']","[{'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",61.0,0.115174,Higher scores of related-handicap at baseline predicted better outcome of tinnitus handicap (45% variance) in the manual therapy with exercise/education group.,"[{'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Plaza-Manzano', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Delgado-de-la-Serna', 'Affiliation': 'Department of Physical Therapy, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Díaz-Arribas', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Diana P', 'Initials': 'DP', 'LastName': 'Rodrigues-de-Souza', 'Affiliation': 'Department of Physical Therapy, Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alburquerque-Sendín', 'Affiliation': 'Department of Physical Therapy, Universidad de Córdoba, Córdoba, Spain.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12919']
1954,26175552,Evaluating Mechanical Bowel Preparation Prior to Total Laparoscopic Hysterectomy.,"BACKGROUND AND OBJECTIVES
Mechanical bowel preparation (MBP) has been used prior to total laparoscopic hysterectomy (TLH), but evidence for its use is lacking. Our study seeks to assess whether or not completion of preoperative MBP prior to TLH improves visualization of the surgical field, bowel handling, or overall ease of the operation.
METHODS
Women aged 18-65 years undergoing TLH for benign indications at a level 1 trauma center were randomized to a bowel preparation (BP; n = 39) or non-bowel preparation (NP; n = 39) regimen. After each operation, the surgeon completed a survey about intraoperative visualization of the surgical field, bowel handling, and the overall ease of the operation. The surgeon was also asked whether or not he thought the patient had completed MBP. The patient completed a survey about pre- and postoperative gastrointestinal discomfort. The surgeon was blinded to whether MBP was completed before the operation.
RESULTS
There was no difference in intraoperative visualization, bowel handling, or overall ease of the operation between the BP and NP groups. Comfort levels before and after surgery were not significantly different between the two groups. The surgeon was able to correctly predict whether the patient performed MBP in 59% of cases.
CONCLUSION
The routine use of MBP before TLH does not improve intraoperative visualization, bowel handling, or overall ease of performing the procedure. It also has no significant effect on patient comfort levels. MBP is not indicated before TLH for benign indications.",2015,"There was no difference in intraoperative visualization, bowel handling, or overall ease of the operation between the BP and NP groups.",['Women aged 18-65 years undergoing TLH for benign indications at a level 1 trauma center'],"['TLH', 'total laparoscopic hysterectomy (TLH', 'bowel preparation (BP; n = 39) or non-bowel preparation', 'Mechanical Bowel Preparation Prior to Total Laparoscopic Hysterectomy']","['MBP', 'Comfort levels', 'intraoperative visualization, bowel handling, or overall ease of the operation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0662675', 'cui_str': '(18F)MBP'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0018578', 'cui_str': 'Handling'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",,0.101051,"There was no difference in intraoperative visualization, bowel handling, or overall ease of the operation between the BP and NP groups.","[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Ryan', 'Affiliation': 'Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Vicki Sue-Mei', 'Initials': 'VS', 'LastName': 'Ng', 'Affiliation': ""Department of Obstetrics and Gynecology, St. Luke's Women's Center, San Francisco, California.""}, {'ForeName': 'Haleh', 'Initials': 'H', 'LastName': 'Sangi-Haghpeykar', 'Affiliation': 'Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2015.00035']
1955,31047023,I Am the Clinical Trial.,,2019,,[],[],[],[],[],[],,0.02603,,"[{'ForeName': 'Jillianne', 'Initials': 'J', 'LastName': 'Code', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2018.12.019']
1956,31047734,Re: Evaluation of Intense Androgen Deprivation Before Prostatectomy: A Randomized Phase II Trial of Enzalutamide and Leuprolide With or Without Abiraterone.,,2019,,['Intense Androgen Deprivation Before Prostatectomy'],['Enzalutamide and Leuprolide With or Without Abiraterone'],[],"[{'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}]",[],,0.0205836,,"[{'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Devos', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium. Electronic address: gaetan.devos@uzleuven.be.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'De Meerleer', 'Affiliation': 'Department of Radiotherapy, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Charlien', 'Initials': 'C', 'LastName': 'Berghen', 'Affiliation': 'Department of Radiotherapy, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}]",European urology,['10.1016/j.eururo.2019.04.023']
1957,26240539,Noninvasive intracranial pressure monitoring via optic nerve sheath diameter for robotic surgery in steep Trendelenburg position.,"BACKGROUND
Recent reports of increased intracranial pressure (ICP) due to steep Trendelenburg (ST) position causing neurological deterioration, decreased regional cerebral oxygen saturation and postoperative visual loss after robotic urological and gynecological surgeries led us to consider a simple technique of ICP monitoring. Ours is one of the first instances reported of quantitative noninvasive measurement of increase in ICP with ST position by serial measurement of binocular optic nerve sheath diameter (ONSD) in patients undergoing robot assisted urological and gynecological oncosurgery. We tested whether ONSD values rose to above the upper limits of normal and for what length of time they remained elevated.
MATERIALS AND METHODS
Prospective, randomized, interventional, parallel group, active control study conducted on 252 American Society of Anesthesiologists I and II patients. ONSD was measured using 7.5 MHz linear ultrasound probe in supine and Trendelenburg positions.
STATISTICS
Student's t-test to compare the inter-group mean ONSD and the repetitive t-test for intra-group analysis.
RESULT
Comparison of the mean ONSD values of both groups yielded a 2-tailed significance P <0.01 at all compared time points intra- and post-operatively. In Group-O (open surgery; supine position), the baseline mean bilateral ONSD was 4.36 mm, which did not show any statistically significant change throughout open surgery and postoperative period. On de-docking the robot, 6.2 mm was the mean ONSD value in Group-R (robotic group) while 4.3 mm was the corresponding value in control Group-O.
CONCLUSION
ONSD evaluation is a simple, quick, safe, readily available, reliable, cost effective, noninvasive, potential standard of care for screening and monitoring of patients undergoing robotic surgery in ST position.",2015,"Group-O.
CONCLUSION
ONSD evaluation is a simple, quick, safe, readily available, reliable, cost effective, noninvasive, potential standard of care for screening and monitoring of patients undergoing robotic surgery in ST position.","['patients undergoing robot assisted urological and gynecological oncosurgery', '252 American Society of Anesthesiologists I and II patients', ""Student's t-test to compare the inter-group mean"", 'patients undergoing robotic surgery in ST position']",['Noninvasive intracranial pressure monitoring via optic nerve sheath diameter for robotic surgery'],"['mean ONSD value', 'mean ONSD values', 'ONSD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]","[{'cui': 'C0150260', 'cui_str': 'ICP-intracranial pressure monitoring'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",252.0,0.0412653,"Group-O.
CONCLUSION
ONSD evaluation is a simple, quick, safe, readily available, reliable, cost effective, noninvasive, potential standard of care for screening and monitoring of patients undergoing robotic surgery in ST position.","[{'ForeName': 'Shagun Bhatia', 'Initials': 'SB', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.'}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Bhargava', 'Affiliation': 'Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.'}, {'ForeName': 'Itee', 'Initials': 'I', 'LastName': 'Choudhury', 'Affiliation': 'Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154693']
1958,26240540,Comparative study between sugammadex and neostigmine in neurosurgical anesthesia in pediatric patients.,"BACKGROUND
Postoperative recurarization remains a risk following the use of the conventional neuromuscular blocking agents. In addition, none of the commonly used reversal agents, such as neostigmine or edrophonium are capable of reliably reversing profound blockade. The present comparative and randomized study investigated the use of sugammadex for reversing profound neuromuscular blockade (NMB) in pediatric neurosurgical patients undergone posterior fossa tumor excision.
PATIENTS AND METHODS
Forty pediatric patients undergoing elective craniotomy for posterior fossa tumor excision were randomly divided into either of neostigmine or sugammadex group in which muscle relaxant was reversed at the end of anesthesia either with neostigmine 0.04 mg/kg added to atropine 0.02 mg/kg or sugammadex 4 mg/kg alone, respectively. The primary endpoint was the time from the administration of sugammadex or neostigmine to recovery of the train of four (TOF) ratio to 90% after rocuronium-induced neuromuscular block. Unpaired t-test was used to compare continuous variables between groups. Meanwhile, repeated ANOVA was used to detect intragroup differences.
RESULTS
Patients in sugammadex group attained a TOF ratio 90% in statistically shorter time (1.4 ± 1.2 min) than those in neostigmine group (25.16 ± 6.49 min) for reversal of the rocuronium. Mean arterial pressure and heart rate were significantly higher in neostigmine group at 2, 5 and 10 min after administration of the reversal agents and returned nonsignificantly different after that. With no recurarization in any patient throughout the study period.
CONCLUSION
Sugammadex rapidly and effectively reverses rocuronium-induced NMB in pediatric patients undergoing neurosurgery when administered at reappearance of T2 of TOF at dose 4 mg/kg.",2015,"Mean arterial pressure and heart rate were significantly higher in neostigmine group at 2, 5 and 10 min after administration of the reversal agents and returned nonsignificantly different after that.","['pediatric patients', 'Forty pediatric patients undergoing elective craniotomy for posterior fossa tumor excision', 'pediatric patients undergoing neurosurgery', 'pediatric neurosurgical patients undergone posterior fossa tumor excision']","['neostigmine', 'sugammadex and neostigmine', 'neostigmine or sugammadex group in which muscle relaxant', 'neostigmine or edrophonium', 'neostigmine 0.04 mg/kg added to atropine 0.02 mg/kg or sugammadex 4 mg/kg alone, respectively', 'sugammadex']","['Sugammadex rapidly and effectively reverses rocuronium-induced NMB', 'neuromuscular block', 'Mean arterial pressure and heart rate', 'time from the administration of sugammadex or neostigmine to recovery of the train of four (TOF) ratio', 'TOF ratio']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0021432', 'cui_str': 'Posterior Fossa Tumors'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}, {'cui': 'C0013615', 'cui_str': 'Edrophonium'}, {'cui': 'C4517407', 'cui_str': 'Zero point zero four'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C4517398', 'cui_str': '0.02'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0428698', 'cui_str': 'Train of four ratio (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",40.0,0.23139,"Mean arterial pressure and heart rate were significantly higher in neostigmine group at 2, 5 and 10 min after administration of the reversal agents and returned nonsignificantly different after that.","[{'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Ghoneim', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'El Beltagy', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154696']
1959,26240541,Comparison of pregabalin versus ketamine in postoperative pain management in breast cancer surgery.,"BACKGROUND
Breast surgery compromises one of the most common cancer surgeries in females and commonly followed by acute postoperative pain. Pregabalin and ketamine have been used in many previous studies and was found to have a good analgesic profile. We assumed that pregabalin and ketamine can be used in control of postoperative pain in female patients undergoing breast cancer surgery.
MATERIAL AND METHODS
Ninety female patients scheduled for cancer breast surgery were allocated in three groups (30 patients each), control group (group c) received preoperative placebo, pregabalin group (group p) received oral 150 mg pregabalin 1 h before surgery, ketamine group (group k) received intravenous (IV) 0.5 mg/kg ketamine with induction of anesthesia followed by 0.25 mg/kg/h IV throughout the surgery. All patients received general anesthesia and after recovery, the three groups were assessed in the first postoperative 24 h for postoperative visual analog scale (VAS), total 24 h morphine consumption, incidence of postoperative nausea and vomiting (PONV), sedation score >2 and any complications from the drugs used in the study.
RESULTS
The use of pregabalin or ketamine was found to reduce total postoperative morphine consumption with P < 0.001. There was no difference between pregabalin and ketamine groups in opioid requirement. There was no difference between the three groups in postoperative VAS scores or incidence of PONV and sedation score >2.
CONCLUSION
The use of preoperative oral 150 mg pregabalin 1 h before surgery or IV 0.5 mg ketamine with induction of anesthesia can reduce postoperative opioid consumption in breast cancer surgery without change in sedation or PONV and with a good safety profile.",2015,The use of pregabalin or ketamine was found to reduce total postoperative morphine consumption with P < 0.001.,"['breast cancer surgery', 'female patients undergoing breast cancer surgery', 'Ninety female patients scheduled for cancer breast surgery']","['pregabalin or ketamine', 'pregabalin and ketamine', 'pregabalin', 'oral 150 mg pregabalin 1 h before surgery, ketamine', 'intravenous (IV) 0.5 mg/kg ketamine with induction of anesthesia followed by 0.25 mg/kg/h IV throughout the surgery', 'Pregabalin', 'ketamine', 'preoperative oral 150 mg pregabalin', 'preoperative placebo, pregabalin', 'ketamine with induction of anesthesia']","['postoperative VAS scores or incidence of PONV and sedation score >2', 'postoperative visual analog scale (VAS), total 24 h morphine consumption, incidence of postoperative nausea and vomiting (PONV), sedation score >2 and any complications', 'postoperative opioid consumption', 'total postoperative morphine consumption']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",90.0,0.0350969,The use of pregabalin or ketamine was found to reduce total postoperative morphine consumption with P < 0.001.,"[{'ForeName': 'Essam', 'Initials': 'E', 'LastName': 'Mahran', 'Affiliation': 'Department of Anesthesia, ICU, and Pain Therapy National Cancer Institute, Cairo University, Giza, Egypt.'}, {'ForeName': 'Mohamed Elsayed', 'Initials': 'ME', 'LastName': 'Hassan', 'Affiliation': 'Department of Anesthesia, ICU, and Pain Therapy National Cancer Institute, Cairo University, Giza, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154697']
1960,30862278,A randomised controlled trial comparing compression therapy after stripping for primary great saphenous vein incompetence.,,2019,"The intervention group (4 h) showed a 57 mL reduction in leg volume after 14 days, compared to 6 mL of the control group (72 h) ( p = 0.11).","['Patients in the Zuyderland Medical Centre with an indication for stripping of the great saphenous vein were eligible for inclusion in this study', '78 patients were randomised, 36 patients enrolled the intervention (4 h) group and 42 patients the control group (72 h', 'primary great saphenous vein incompetence']","['leg compression (standard elastic bandaging) after stripping of the great saphenous vein', 'compression therapy', 'leg compression after great saphenous vein stripping']","['leg volume', 'leg oedema', 'Post-operative pain, complications and time to full recovery', 'change in leg volume', 'post-operative pain scores, complications and time to full recovery', 'pain and time to full recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0235886', 'cui_str': 'Leg edema'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",78.0,0.251515,"The intervention group (4 h) showed a 57 mL reduction in leg volume after 14 days, compared to 6 mL of the control group (72 h) ( p = 0.11).","[{'ForeName': 'Attila G', 'Initials': 'AG', 'LastName': 'Krasznai', 'Affiliation': 'Department of Vascular Surgery, Zuyderland Medical Centre, Heerlen, The Netherland.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Sigterman', 'Affiliation': 'Department of Surgery, Viecuri Medical Centre, Venlo, the Netherlands.'}, {'ForeName': 'Janine P', 'Initials': 'JP', 'LastName': 'Houtermans-Auckel', 'Affiliation': 'Department of Surgery, Viecuri Medical Centre, Venlo, the Netherlands.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Eussen', 'Affiliation': 'Department of Vascular Surgery, Zuyderland Medical Centre, Heerlen, The Netherland.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Snoeijs', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Kees Jan Jm', 'Initials': 'KJJ', 'LastName': 'Sikkink', 'Affiliation': 'Department of Vascular Surgery, Zuyderland Medical Centre, Heerlen, The Netherland.'}, {'ForeName': 'Edith M', 'Initials': 'EM', 'LastName': 'de Boer', 'Affiliation': 'Department of Dermatology, VU Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Cees Ha', 'Initials': 'CH', 'LastName': 'Wittens', 'Affiliation': 'Department of Venous Surgery, Maastricht University Medical Centre, the Netherlands.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Bouwman', 'Affiliation': 'Department of Vascular Surgery, Zuyderland Medical Centre, Heerlen, The Netherland.'}]",Phlebology,['10.1177/0268355519833255']
1961,26240550,"Efficacy of trans abdominis plane block for post cesarean delivery analgesia: A double-blind, randomized trial.","BACKGROUND
The transverse abdominis plane (TAP) block, a regional block provides effective analgesia after lower abdominal surgeries if used as part of multimodal analgesia. In this prospective, randomized double-blind study, we determined the efficacy of TAP block in patients undergoing cesarean section.
MATERIALS AND METHODS
Totally, 62 parturients undergoing cesarean section were randomized in a double-blind manner to receive either bilateral TAP block at the end of surgery with 20 ml of 0.25% bupivacaine or no TAP block, in addition to standard analgesic comprising 75 mg diclofenac 8 hourly and intravenous patient-controlled analgesia (PCA) tramadol. Each patient was assessed at 0, 4, 8, 12, 24, 36, and 48 h after surgery by an independent observer for pain at rest and on movement using numeric rating scale of 0-10, time of 1(st) demand for tramadol, total consumption of PCA tramadol, satisfaction with pain management and side effects.
RESULTS
Use of tramadol was reduced in patients given TAP block by 50% compared to patients given no block during 48 h after surgery (P < 0.001). Pain scores were lower both on rest and activity at each time point for 24 h in study group (P < 0.001), time of first analgesia was significantly longer, satisfaction was higher, and side effects were less in study group compared to control group.
CONCLUSION
Transverse abdominis plane block was effective in providing analgesia with a substantial reduction in tramadol use during 48 h after cesarean section when used as adjunctive to standard analgesia.",2015,"Pain scores were lower both on rest and activity at each time point for 24 h in study group (P < 0.001), time of first analgesia was significantly longer, satisfaction was higher, and side effects were less in study group compared to control group.
","['post cesarean delivery analgesia', 'patients undergoing cesarean section', 'Totally, 62 parturients undergoing cesarean section']","['bilateral TAP block at the end of surgery with 20 ml of 0.25% bupivacaine or no TAP block, in addition to standard analgesic comprising 75 mg diclofenac 8 hourly and intravenous patient-controlled analgesia (PCA) tramadol', 'tramadol', 'TAP block', 'trans abdominis plane block']","['side effects', 'time of first analgesia', 'TAP block', 'pain at rest and on movement using numeric rating scale of 0-10, time of 1(st) demand for tramadol, total consumption of PCA tramadol, satisfaction with pain management and side effects', 'Pain scores']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0222045'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",62.0,0.481941,"Pain scores were lower both on rest and activity at each time point for 24 h in study group (P < 0.001), time of first analgesia was significantly longer, satisfaction was higher, and side effects were less in study group compared to control group.
","[{'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Srivastava', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sarojini Naidu Medical College, Agra, Uttar Pradesh, India.'}, {'ForeName': 'Shilpi', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sarojini Naidu Medical College, Agra, Uttar Pradesh, India.'}, {'ForeName': 'Tapas Kumar', 'Initials': 'TK', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sarojini Naidu Medical College, Agra, Uttar Pradesh, India.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sarojini Naidu Medical College, Agra, Uttar Pradesh, India.'}, {'ForeName': 'Avanish', 'Initials': 'A', 'LastName': 'Saxsena', 'Affiliation': 'Department of Surgery, Sarojini Naidu Medical College, Agra, Uttar Pradesh, India.'}, {'ForeName': 'Keshav Dev', 'Initials': 'KD', 'LastName': 'Jagar', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sarojini Naidu Medical College, Agra, Uttar Pradesh, India.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sarojini Naidu Medical College, Agra, Uttar Pradesh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154732']
1962,26240542,Dexmedetomidine versus propofol in dilatation and curettage: An open-label pilot randomized controlled trial.,"BACKGROUND
Traditionally propofol has been used for providing sedation in dilatation and curettage (D and C). Recently, dexmedetomidine has been tried, but very little evidence exists to support its use.
AIMS
The aim was to compare hemodynamic and recovery profile of both the drugs along with a degree of comfort experienced by patients and the usefulness of the drug to surgeons.
SETTINGS AND DESIGN
Tertiary care center and open-label randomized controlled trial.
MATERIALS AND METHODS
Patients posted for D and C were enrolled in two groups (25 each). Both groups received fentanyl 1 μg/kg intravenous (IV) at the beginning of the procedure. Group P received IV propofol in dose of 1.5 mg/kg over 10-15 min and Group D received dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by 0.5 μg/kg/h infusion until Ramsay sedation score reached 3-4. Hemodynamic vitals were compared during and after the procedure. In the recovery room time to reach modified Aldrete score (MAS) of 9-10 and patient's and surgeon's satisfaction scores were also recorded and compared.
RESULTS
In Group D, patients had statistically significant lower heart rate at 2, 5, 10 and 15 min as compared to Group P. Hypotension was present in 52% in Group P and 4% in Group D (P < 0.05). MAS of 9-10 was achieved in 4.4 min in subjects in Group D in contrast to 16.2 min in Group P (P < 0.05). Group D showed higher patient and surgeon satisfaction scores (P < 0.05).
CONCLUSION
Dexmedetomidine provide better hemodynamic and recovery profile than propofol. It can be a superior alternative for short surgical day care procedures.",2015,"Group D showed higher patient and surgeon satisfaction scores (P < 0.05).
","['dilatation and curettage', 'Patients posted for D and C were enrolled in two groups (25 each']","['Dexmedetomidine', 'fentanyl', 'propofol', 'IV propofol', 'dexmedetomidine']","['Hemodynamic vitals', ""recovery room time to reach modified Aldrete score (MAS) of 9-10 and patient's and surgeon's satisfaction scores"", 'heart rate', 'MAS', 'higher patient and surgeon satisfaction scores', 'Hypotension']","[{'cui': 'C0012358', 'cui_str': 'D&C'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",,0.0976785,"Group D showed higher patient and surgeon satisfaction scores (P < 0.05).
","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sethi', 'Affiliation': 'Department of Anesthesiology, Dr. S.N. Medical College, Jodhpur, Rajasthan, India ; Department of Anesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sindhi', 'Affiliation': 'Department of Anesthesiology, Dr. S.N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Anesthesiology, Dr. S.N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Tulsiani', 'Affiliation': 'Department of Anesthesiology, Dr. S.N. Medical College, Jodhpur, Rajasthan, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154699']
1963,26240543,Fentanyl versus tramadol with levobupivacaine for combined spinal-epidural analgesia in labor.,"BACKGROUND
Neuraxial labor analgesia using new local anesthetics such as levobupivacaine has become very popular by virtue of the safety and lesser motor blockade caused by these agents. Combined spinal-epidural analgesia (CSEA) has become the preferred method for labor analgesia as it combines benefits of both spinal analgesia and flexibility of the epidural catheter. Adding opioids to local anesthetic drugs provide rapid onset and prolonged analgesia but may be associated with several maternal and fetal adverse effects. The purpose of this study is to compare fentanyl and tramadol used in CSEA in terms of duration of analgesia and frequency of the adverse fetomaternal outcome.
MATERIALS AND METHODS
A total of 60 primiparas with a singleton pregnancy in active labor were given CSEA after randomly allocating them in two groups of 30 each. Group I received intrathecal 2.5 mg levobupivacaine + 25 μg fentanyl followed by epidural top ups of 20 ml 0.125% solution of the same combination. Group II received 25 mg tramadol instead of fentanyl. Epidural top ups were given when parturient complained of two painful contractions (visual analogue scale ≥ 4). Data collected were demographic profile of the patients, analgesic qualities, side- effects and the fetomaternal outcome.
RESULTS
Patients in Group II had significantly prolonged analgesia (145 ± 9 minutes) than in Group I (95 ± 7 minutes). Patients receiving fentanyl showed rapid onset of analgesia, but there were more incidence of side-effects like shivering, pruritus, transient fetal bradycardia, hypotension, nausea and vomiting. Only side-effect in the tramadol group was nausea and vomiting. During labor, maternal satisfaction was excellent.
CONCLUSIONS
Adding tramadol to local anesthetic provides prolonged analgesia with minimal side effects. Fentanyl, when used as adjuvant to local anesthetic, has a rapid onset of analgesia but has certain fetomaternal side-effects.",2015,"Patients receiving fentanyl showed rapid onset of analgesia, but there were more incidence of side-effects like shivering, pruritus, transient fetal bradycardia, hypotension, nausea and vomiting.","['60 primiparas with a singleton pregnancy in active labor', 'combined spinal-epidural analgesia in labor']","['Fentanyl', 'Combined spinal-epidural analgesia (CSEA', 'Fentanyl versus tramadol with levobupivacaine', 'fentanyl', 'fentanyl and tramadol', 'tramadol instead of fentanyl', 'tramadol', 'levobupivacaine', 'intrathecal 2.5 mg levobupivacaine ', 'CSEA']","['nausea and vomiting', 'rapid onset of analgesia', 'duration of analgesia and frequency of the adverse fetomaternal outcome', 'prolonged analgesia', 'incidence of side-effects like shivering, pruritus, transient fetal bradycardia, hypotension, nausea and vomiting']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0233081', 'cui_str': 'Normal labor (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0410919', 'cui_str': 'Fetal bradycardia (disorder)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",60.0,0.0617189,"Patients receiving fentanyl showed rapid onset of analgesia, but there were more incidence of side-effects like shivering, pruritus, transient fetal bradycardia, hypotension, nausea and vomiting.","[{'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Chatrath', 'Affiliation': 'Department of Medicine, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Ranjana', 'Initials': 'R', 'LastName': 'Khetarpal', 'Affiliation': 'Department of Medicine, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Kumari', 'Affiliation': 'Department of Medicine, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Sudha', 'Affiliation': 'Department of Medicine, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Kusum', 'Initials': 'K', 'LastName': 'Bali', 'Affiliation': 'Department of Anesthesia, PIMS, Jalandhar, Punjab, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154700']
1964,26240544,Regional anesthesia in transurethral resection of prostate (TURP) surgery: A comparative study between saddle block and subarachnoid block.,"BACKGROUND
Spinal anesthesia is the technique of choice in transurethral resection of prostate (TURP). The major complication of spinal technique is risk of hypotension. Saddle block paralyzed pelvic muscles and sacral nerve roots and hemodynamic derangement is less.
AIMS AND OBJECTIVES
To compare the hemodynamic changes and adequate surgical condition between saddle block and subarachnoid block for TURP.
MATERIAL AND METHODS
Ninety patients of aged between 50 to 70 years of ASA-PS I, II scheduled for TURP were randomly allocated into 2 groups of 45 in each group. Group A patients were received spinal (2 ml of hyperbaric bupivacaine) and Group B were received saddle block (2 ml of hyperbaric bupivacaine). Baseline systolic, diastolic and mean arterial pressure, heart rate, oxygen saturation were recorded and measured subsequently. The height of block was noted in both groups. Hypotension was corrected by administration of phenylephrine 50 mcg bolus and total requirement of vasopressor was noted. Complications (volume overload, TURP syndrome etc.) were noted.
RESULTS
Incidence of hypotension and vasopressor requirement was less (P < 0.01) in Gr B patients. Adequate surgical condition was achieved in both groups. There was no incidence of volume overload, TURP syndrome, and bladder perforation.
CONCLUSION
TURP can be safely performed under saddle block without hypotension and less vasopressor requirement.",2015,"RESULTS
Incidence of hypotension and vasopressor requirement was less (P < 0.01) in Gr B patients.","['transurethral resection of prostate (TURP', 'Ninety patients of aged between 50 to 70 years of ASA-PS I, II scheduled for TURP']","['transurethral resection of prostate (TURP) surgery', 'Regional anesthesia', 'saddle block (2 ml of hyperbaric bupivacaine', 'TURP', 'phenylephrine', 'spinal (2 ml of hyperbaric bupivacaine']","['hypotension and vasopressor requirement', 'volume overload, TURP syndrome, and bladder perforation', 'Baseline systolic, diastolic and mean arterial pressure, heart rate, oxygen saturation', 'Complications (volume overload, TURP syndrome etc', 'Adequate surgical condition', 'Hypotension', 'height of block']","[{'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0647347', 'cui_str': 'ASA-PS'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0394826', 'cui_str': 'Saddle block (procedure)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}, {'cui': 'C0580179', 'cui_str': 'TURP syndrome'}, {'cui': 'C0434133', 'cui_str': 'Perforation of bladder (disorder)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",90.0,0.0628044,"RESULTS
Incidence of hypotension and vasopressor requirement was less (P < 0.01) in Gr B patients.","[{'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Anaesthesiology, Burdwan Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Subrata', 'Initials': 'S', 'LastName': 'Bisai', 'Affiliation': 'Department of Anaesthesiology, Burdwan Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Hirak', 'Initials': 'H', 'LastName': 'Biswas', 'Affiliation': 'Department of Anaesthesiology, Burdwan Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Mandeep Kumar', 'Initials': 'MK', 'LastName': 'Tiwary', 'Affiliation': 'Department of Anaesthesiology, Burdwan Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Suchismita', 'Initials': 'S', 'LastName': 'Mallik', 'Affiliation': 'Department of Anaesthesiology, Burdwan Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Swarna Mukul', 'Initials': 'SM', 'LastName': 'Saha', 'Affiliation': 'Department of Anaesthesiology, Burdwan Medical College and Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.158497']
1965,26240545,Effectiveness of intravenous infusion of N-acetylcysteine in cirrhotic patients undergoing major abdominal surgeries.,"BACKGROUND
Postoperative acute kidney injury (AKI) is common in patients with chronic liver disease. We prospectively evaluated effectiveness of the N-acetylcysteine (NAC) in preserving postoperative renal functions in cirrhotic patients undergoing major abdominal surgeries.
MATERIALS AND METHODS
A total of 60 cirrhotic patients child A to B were randomized into two groups of 30 each. NAC groupwas received intravenous infusion of NAC (1200 mg/12h starting immediately before surgery and continued for 72h h postoperative) and controls group received a similar volume of glucose 5% solution as a a placebo. Systemic hemodynamics, hepatic and renal functions, serum cystatin C and cystatin C glomerular filtration rate (GFR) (GFR) were compared between both groups.
RESULTS
Serum level of cystatin C was raised significantly above the basal value at postoperative day 1 and day 3 associated with significantly decreased in cystatin C GFR below the basal value in the control group (P = 0.001). 6 (20%) (PP = 0.03) in control group developed AKI based on cystatin C GFR criteria (GFR <55 ml/min/1.73m(2)). Mean values of alanine aminotransferase and aspartate aminotransferase were increased significantly above the basal values in both groups, but the increases were significantly lower in NAC group (P = 0.00). Chest infection was significantly lower associated with shorter hospital stay in the NAC group than the control group.
CONCLUSION
Intravenous administration of NAC NAC in cirrhotic patients undergoing major abdominal surgeries reduces the incidence of cystatin C GFR-based AKI, postoperative renal and liver functions were well-preserved and improved outcome.",2015,"Mean values of alanine aminotransferase and aspartate aminotransferase were increased significantly above the basal values in both groups, but the increases were significantly lower in NAC group (P = 0.00).","['patients with chronic liver disease', 'cirrhotic patients undergoing major abdominal surgeries', '60 cirrhotic patients child A to B']","['NAC NAC', 'intravenous infusion of NAC', 'N-acetylcysteine (NAC', 'similar volume of glucose 5% solution as a a placebo', 'intravenous infusion of N-acetylcysteine']","['Systemic hemodynamics, hepatic and renal functions, serum cystatin C and cystatin C glomerular filtration rate (GFR) (GFR', 'Mean values of alanine aminotransferase and aspartate aminotransferase', 'cystatin C GFR', 'hospital stay', 'incidence of cystatin C GFR-based AKI, postoperative renal and liver functions', 'Chest infection', 'Serum level of cystatin C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.060089,"Mean values of alanine aminotransferase and aspartate aminotransferase were increased significantly above the basal values in both groups, but the increases were significantly lower in NAC group (P = 0.00).","[{'ForeName': 'Eman Sayed', 'Initials': 'ES', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesia, National Liver Institute, Menofeya University, Menofeya, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sharawy', 'Affiliation': 'Department of Clinical Pathology, National Liver Institute, Menofeya University, Menofeya, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154706']
1966,26240546,Femoral nerve block versus adductor canal block for postoperative pain control after anterior cruciate ligament reconstruction: A randomized controlled double blind study.,"BACKGROUND
The objective of this study was to evaluate the reliability of the postoperative pain control using adductor canal block (ACB) compared that using the femoral nerve block (FNB) in patients with anterior cruciate ligament reconstructions (ACLR).
MATERIALS AND METHODS
One hundred and twenty-eight patients who had been scheduled to patellar graft ACLR were included in this double blind study, and were randomly allocated into two groups; group ACB and group FNB (64 patients each). All patients received general anesthesia. At the end of the surgery, patients in group FNB received a FNB and those in group ACB received an ACB. The postoperative pain (visual analog scale [VAS]) and muscle weakness were assessed in the postoperative care unit and every 6 h thereafter for 24 h. The total morphine requirements were also recorded.
RESULTS
Patients in group ACB had significantly higher VAS (at 18 h and 24 h), higher morphine consumption, but significantly less quadriceps weakness than those in group FNB.
CONCLUSION
In patients with patellar graft ACLR, the ACB can maintain a higher quadriceps power, but with lesser analgesia compared with the FNB.",2015,"RESULTS
Patients in group ACB had significantly higher VAS (at 18 h and 24 h), higher morphine consumption, but significantly less quadriceps weakness than those in group FNB.
","['One hundred and twenty-eight patients who had been scheduled to patellar graft ACLR', 'patients with anterior cruciate ligament reconstructions (ACLR', 'postoperative pain control after anterior cruciate ligament reconstruction']","['adductor canal block (ACB', 'Femoral nerve block versus adductor canal block', 'femoral nerve block (FNB', 'general anesthesia', 'ACB']","['quadriceps weakness', 'VAS', 'total morphine requirements', 'postoperative pain (visual analog scale [VAS]) and muscle weakness']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}]",128.0,0.102904,"RESULTS
Patients in group ACB had significantly higher VAS (at 18 h and 24 h), higher morphine consumption, but significantly less quadriceps weakness than those in group FNB.
","[{'ForeName': 'Mohamed Sayed', 'Initials': 'MS', 'LastName': 'El Ahl', 'Affiliation': 'Lecturer of Anesthesia, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154708']
1967,26240547,Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study.,"BACKGROUND
Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children.
MATERIALS AND METHODS
After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED95; Group 75: Received atracurium at 75% dose of ED95; Group 100: Received atracurium of 100% dose of ED95. Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group.
RESULTS
The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001). Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001) with the least satisfaction in Group 0. The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001). However, number of attempts for LMA placement was comparable among the four groups (P - 0.766).
CONCLUSION
We conclude that a balanced anesthetic technique including atracurium provided better surgical condition for cataract procedures in children. The surgical condition improved with increasing dose of atracurium from 25% to 100% ED95 dose.",2015,The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001).,"['cataract surgery in children', 'children scheduled for cataract surgery under general anesthesia', 'children']","['atracurium of 100% dose of ED95', 'atracurium at 75% dose of ED95', 'atracurium', 'atracurium at 50% dose of ED95']","['surgeon satisfaction score', 'need of atracurium supplementation based on grading of surgical conditions', 'number of attempts for LMA placement', 'laryngeal mask airway (LMA) insertion score']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0396618', 'cui_str': 'Laryngeal mask airway insertion (procedure)'}]",,0.274539,The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001).,"[{'ForeName': 'Vanlal', 'Initials': 'V', 'LastName': 'Darlong', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Pandey', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Khokhar', 'Affiliation': 'Department of Opthalmology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Chandralekha', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Punj', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Opthalmology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154711']
1968,26240549,"Ultrasound-guided ilioinguinal and iliohypogastric nerve block, a comparison with the conventional technique: An observational study.","BACKGROUND
The conventional technique of ilioinguinal and iliohypogastric nerve block may be associated with drug toxicity, block failure and needs large drug volume. The ultrasound-guided (USG) nerve block enables accurate needle positioning that may reduce the chances of drug toxicity, drug dose and block failure.
AIM
In this study, we compared the onset and duration of the motor and sensory nerve block, the drug volume required and time to rescue analgesic between USG and conventional technique.
SETTINGS AND DESIGN
Sixty male patients aged between 18 and 60 years, belonging to American society of Anesthesiology I-II, scheduled for inguinal hernia repair were enrolled in this prospective study and were randomly allocated into two groups of thirty each by computerized method.
MATERIALS AND METHODS
Group A patients received hernia block by conventional method using 0.75% ropivacaine 15 ml, and Group B patients were given the block guided by ultrasound using 0.75% ropivacaine, till the nerves were surrounded on all sides by the drug.
STATISTICAL ANALYSIS
The data were analyzed using two independent sample t-tests for demographic and hemodynamic parameters. Nonparametric test (Mann-Whitney U-test) was used to find the significance between visual analog scale.
RESULTS
There was significantly early onset of sensory block in Group B 14.03 ± 2.82 min as compared to Group A 15.57 ± 1.52 min (P = 0.047). The onset of motor block was also earlier in Group B 19.40 ± 2.85 min as compared to Group A 20.67 ± 1.90 min. The time to rescue analgesia was more in Group B 7.22 ± 0.97 h as compared to Group A 6.80 ± 0.70 h (P = 0.062). The volume of drug required was less with ultrasound guided block.
CONCLUSIONS
Ultrasound-guided hernia block thus has the advantage of early onset, less dose requirement and increase in time to rescue analgesia.",2015,The time to rescue analgesia was more in Group B 7.22 ± 0.97 h as compared to Group A 6.80 ± 0.70 h (P = 0.062).,"['Sixty male patients aged between 18 and 60 years, belonging to American society of Anesthesiology I-II, scheduled for inguinal hernia repair', 'Group A patients received']","['conventional technique', 'block guided by ultrasound using 0.75% ropivacaine', 'ultrasound-guided (USG) nerve block', 'hernia block by conventional method using 0.75% ropivacaine', 'Ultrasound-guided ilioinguinal and iliohypogastric nerve block']","['time to rescue analgesia', 'onset of motor block', 'early onset of sensory block']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0394767', 'cui_str': 'Local anesthetic block of iliohypogastric nerve (procedure)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]",60.0,0.0524182,The time to rescue analgesia was more in Group B 7.22 ± 0.97 h as compared to Group A 6.80 ± 0.70 h (P = 0.062).,"[{'ForeName': 'Sunita Milind', 'Initials': 'SM', 'LastName': 'Khedkar', 'Affiliation': 'Department of Anaesthesiology, B. J. Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Pradnya Milind', 'Initials': 'PM', 'LastName': 'Bhalerao', 'Affiliation': 'Department of Anaesthesiology, B. J. Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Shweta Rahul', 'Initials': 'SR', 'LastName': 'Yemul-Golhar', 'Affiliation': 'Department of Anaesthesiology, B. J. Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Kalpana Vinod', 'Initials': 'KV', 'LastName': 'Kelkar', 'Affiliation': 'Department of Anaesthesiology, B. J. Medical College, Pune, Maharashtra, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.154730']
1969,31549903,Use of a Bidirectional Text Messaging System for Emergency Department Follow-Up Versus Usual Follow-Up.,"Background: The use of text messaging is a growing trend. Usual care for follow-up with patients (no dedicated communication) has proven unreliable, and alternative communication methods may be beneficial. Introduction: The objective was to evaluate the effect of text messaging as a means of follow-up communication compared to usual care on patient satisfaction among patients discharged from the emergency department (ED). Materials and Methods: Participants completed a baseline survey about their text message usage and ED visit satisfaction. The participants completed a follow-up survey 2 weeks later. Participants randomized to text messaging received a text message at 24 h, 1 week, and 2 weeks after discharge. Control participants received usual care (typically no dedicated communication). Bivariate analyses were performed, and intent-to-treat and per protocol analyses were completed to examine follow-up satisfaction with ED communication/care. Results: A total of 802 subjects were recruited (text messaging-398 subjects, usual care-404 subjects). In the intent-to-treat analysis, text messaging subjects were not more likely to report satisfaction with follow-up communication (adjusted odds ratio [aOR] 0.90 [0.46-1.75]) or follow-up care (aOR 0.66 [0.30-1.46]) than usual care subjects. In per-protocol analysis, text messaging subjects had 2.95 (1.52-5.73) higher odds of reporting satisfaction with follow-up communication and 3.24 (1.46-7.16) higher odds of reporting satisfaction with follow-up care. Discussion: The use of text messaging for follow-up, when comparing satisfaction with follow-up communication and follow-up care after discharge, performs at least equally as well as usual follow-up. Conclusions: Text messaging is a provider time-saving and resource-conserving technology allowing health care providers to potentially reach a larger proportion of patients, making it a valuable form of follow-up communication.",2020,"In the intent-to-treat analysis, text messaging subjects were not more likely to report satisfaction with follow-up communication (adjusted odds ratio [aOR] 0.90 [0.46-1.75]) or follow-up care (aOR 0.66 [0.30-1.46]) than usual care subjects.","['patients discharged from the emergency department (ED', '802 subjects were recruited (text messaging-398 subjects, usual care-404 subjects']","['Bidirectional Text Messaging System', 'usual care (typically no dedicated communication', 'text messaging']",[],"[{'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",[],802.0,0.0576994,"In the intent-to-treat analysis, text messaging subjects were not more likely to report satisfaction with follow-up communication (adjusted odds ratio [aOR] 0.90 [0.46-1.75]) or follow-up care (aOR 0.66 [0.30-1.46]) than usual care subjects.","[{'ForeName': 'Brooks J', 'Initials': 'BJ', 'LastName': 'Obr', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Young', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Karisa K', 'Initials': 'KK', 'LastName': 'Harland', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nugent', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0002']
1970,25731828,Adherence to Guidelines for Adjuvant Imatinib Therapy for GIST: A Multi-institutional Analysis.,"BACKGROUND
Gastrointestinal stromal tumors (GIST) are the most common mesenchymal tumors of the gastrointestinal tract. Adjuvant imatinib therapy improves recurrence-free and overall survival following surgery for patients with high-risk GIST; however, the factors associated with use of adjuvant imatinib therapy are unclear, and adherence to adjuvant imatinib has not been investigated. We sought to determine the clinicopathologic predictors of therapy with adjuvant imatinib following surgical resection for GIST and to determine the utilization of adjuvant imatinib in patients who underwent surgical resection of primary GIST in 2009 or later as recommended by National Comprehensive Cancer network (NCCN) guidelines.
METHODS
A multi-institutional cohort including 171 patients who underwent surgery for primary GIST at seven high-volume cancer centers in the USA and Canada between January 2009-December 2012 was used in this study. Receipt of adjuvant imatinib therapy was ascertained, and factors associated with imatinib therapy were analyzed.
RESULTS
Following surgery for primary GIST, tumor size (<5.0 cm: ref; 5.0-9.9 cm: odds ratio (OR) 2.36, 95 % confidence interval (CI) 0.74-7.55; >10.0 cm: OR 9.15, 95 % CI 2.28-36.75; p = 0.007), mitotic rate (≤5/50 mitoses per 50 high powered field [HPF]: ref; 6-10/50 HPF: OR 24.91, 95 % CI 3.64-170.35; >10/50 HPF: OR 5.80, 95 % CI 3.64-170.35; p < 0.001), and neoadjuvant therapy (OR 9.52; 95 % CI 2.51-36.14; p = 0.001) were associated with receipt of adjuvant imatinib therapy. Overall, 75 % of patients received appropriate treatment, 23 % of patients were undertreated, and 2 % of patients were overtreated as compared to NCCN guidelines. Adjuvant imatinib therapy was administered in only 53 % of patients for which the NCCN guidelines recommended adjuvant therapy.
CONCLUSION
The clinicopathologic factors associated with use of adjuvant imatinib therapy in patients following resection of primary GIST are consistent with established risk factors for recurrence. Adjuvant imatinib therapy remains underutilized in patients with intermediate and high-risk GIST and in patients who receive neoadjuvant therapy. Barriers to adjuvant imatinib therapy in this group of patients needs to be further explored.",2015,", tumor size (<5.0 cm: ref; 5.0-9.9 cm: odds ratio (OR) 2.36, 95 % confidence interval (CI) 0.74-7.55; >10.0 cm: OR 9.15, 95 % CI 2.28-36.75; p = 0.007), mitotic rate (≤5/50 mitoses per 50 high powered field [HPF]: ref; 6-10/50 HPF: OR 24.91, 95 % CI 3.64-170.35; >10/50 HPF: OR 5.80, 95 % CI 3.64-170.35; p < 0.001), and neoadjuvant therapy (OR 9.52; 95 % CI 2.51-36.14; p = 0.001) were associated with receipt of adjuvant imatinib therapy.","['Following surgery for primary GIST', 'patients with intermediate and high-risk GIST and in patients who receive neoadjuvant therapy', 'patients with high-risk GIST', 'patients following resection of primary GIST', '171 patients who underwent surgery for primary GIST at seven high-volume cancer centers in the USA and Canada between January 2009-December 2012 was used in this study', 'patients who underwent surgical resection of primary GIST in 2009 or later as recommended by National Comprehensive Cancer network (NCCN) guidelines', 'GIST']",['Adjuvant imatinib therapy'],"['recurrence-free and overall survival', 'mitotic rate']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0842973,", tumor size (<5.0 cm: ref; 5.0-9.9 cm: odds ratio (OR) 2.36, 95 % confidence interval (CI) 0.74-7.55; >10.0 cm: OR 9.15, 95 % CI 2.28-36.75; p = 0.007), mitotic rate (≤5/50 mitoses per 50 high powered field [HPF]: ref; 6-10/50 HPF: OR 24.91, 95 % CI 3.64-170.35; >10/50 HPF: OR 5.80, 95 % CI 3.64-170.35; p < 0.001), and neoadjuvant therapy (OR 9.52; 95 % CI 2.51-36.14; p = 0.001) were associated with receipt of adjuvant imatinib therapy.","[{'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Bischof', 'Affiliation': 'Department of Surgery, The Johns Hopkins University, Baltimore, MD, USA, danielle.bischof@gmail.com.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dodson', 'Affiliation': ''}, {'ForeName': 'M Carolina', 'Initials': 'MC', 'LastName': 'Jimenez', 'Affiliation': ''}, {'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Behman', 'Affiliation': ''}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Cocieru', 'Affiliation': ''}, {'ForeName': 'Dan G', 'Initials': 'DG', 'LastName': 'Blazer', 'Affiliation': ''}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Malcolm H', 'Initials': 'MH', 'LastName': 'Squires', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kooby', 'Affiliation': ''}, {'ForeName': 'Shishir K', 'Initials': 'SK', 'LastName': 'Maithel', 'Affiliation': ''}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Groeschl', 'Affiliation': ''}, {'ForeName': 'T Clark', 'Initials': 'TC', 'LastName': 'Gamblin', 'Affiliation': ''}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Bauer', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Karanicolas', 'Affiliation': ''}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Law', 'Affiliation': ''}, {'ForeName': 'Fayez A', 'Initials': 'FA', 'LastName': 'Quereshy', 'Affiliation': ''}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Pawlik', 'Affiliation': ''}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-015-2782-7']
1971,26163352,Transtheoretical Model Constructs' Longitudinal Prediction of Sun Protection Over 24 Months.,"PURPOSE
This research examined dynamic transtheoretical model (TTM) constructs for adopting sun protection practices. This secondary data analysis pooled four large population-based TTM-tailored intervention studies and examined use of constructs across three groups, organized by longitudinal progress: maintainers, relapsers, and stable non-changers.
METHODS
A total of 3463 adults, in the USA, who met criteria for unsafe sun exposure at baseline received a TTM-tailored computerized intervention at baseline, 6 months, and 12 months. The final analytic sample consisted of 1894 participants; the majority were female, White, married, and middle-aged. The three groups were assessed with reliable and valid scales assessing use of TTM constructs at baseline, 6 months, 12 months, and 24 months. Analyses included a MANOVA followed by a series of ANOVAs, with Tukey follow-up tests assessing differences in use of TTM constructs across the three groups at each timepoint.
RESULTS
Findings demonstrated that relapsers and maintainers were similar in their use of most TTM processes of change at baseline, with the exception of Consciousness Raising, Stimulus Control, Reinforcement Management, and Self-Liberation.
CONCLUSIONS
These findings suggest that although relapsers reverted to unsafe sun practices, their overall greater use of processes of change indicates that their change efforts remain better than that of stable non-changers.",2016,"RESULTS
Findings demonstrated that relapsers and maintainers were similar in their use of most TTM processes of change at baseline, with the exception of Consciousness Raising, Stimulus Control, Reinforcement Management, and Self-Liberation.
","['1894 participants; the majority were female, White, married, and middle-aged', 'A total of 3463 adults, in the USA, who met criteria for unsafe sun exposure at baseline received a']",['TTM-tailored computerized intervention'],"['Consciousness Raising, Stimulus Control, Reinforcement Management, and Self-Liberation']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",[],"[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",3463.0,0.0236203,"RESULTS
Findings demonstrated that relapsers and maintainers were similar in their use of most TTM processes of change at baseline, with the exception of Consciousness Raising, Stimulus Control, Reinforcement Management, and Self-Liberation.
","[{'ForeName': 'Miryam', 'Initials': 'M', 'LastName': 'Yusufov', 'Affiliation': 'Cancer Prevention Research Center, University of Rhode Island, 130 Flagg Road, Kingston, RI, 02881, USA. miryam_yusufov@my.uri.edu.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Rossi', 'Affiliation': 'Cancer Prevention Research Center, University of Rhode Island, 130 Flagg Road, Kingston, RI, 02881, USA.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Redding', 'Affiliation': 'Cancer Prevention Research Center, University of Rhode Island, 130 Flagg Road, Kingston, RI, 02881, USA.'}, {'ForeName': 'Hui-Qing', 'Initials': 'HQ', 'LastName': 'Yin', 'Affiliation': 'Cancer Prevention Research Center, University of Rhode Island, 130 Flagg Road, Kingston, RI, 02881, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Paiva', 'Affiliation': 'Cancer Prevention Research Center, University of Rhode Island, 130 Flagg Road, Kingston, RI, 02881, USA.'}, {'ForeName': 'Wayne F', 'Initials': 'WF', 'LastName': 'Velicer', 'Affiliation': 'Cancer Prevention Research Center, University of Rhode Island, 130 Flagg Road, Kingston, RI, 02881, USA.'}, {'ForeName': 'Geoffrey W', 'Initials': 'GW', 'LastName': 'Greene', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI, 02881, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Blissmer', 'Affiliation': 'Department of Kinesiology, University of Rhode Island, Kingston, RI, 02881, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Robbins', 'Affiliation': 'Cancer Prevention Research Center, University of Rhode Island, 130 Flagg Road, Kingston, RI, 02881, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Prochaska', 'Affiliation': 'Cancer Prevention Research Center, University of Rhode Island, 130 Flagg Road, Kingston, RI, 02881, USA.'}]",International journal of behavioral medicine,['10.1007/s12529-015-9498-7']
1972,31076738,HDAC inhibitors tested in phase III trial.,,2019,,[],[],[],[],[],[],,0.0225855,,"[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Romero', 'Affiliation': 'Nature Reviews Clinical Oncology, . nrclinonc@nature.com.'}]",Nature reviews. Clinical oncology,['10.1038/s41571-019-0224-2']
1973,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE
This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD).
METHODS
This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks.
RESULTS
Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo.
CONCLUSIONS
Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878']
1974,30738709,"Reply to Jae Heon Kim and Benjamin I. Chung's Letter to the Editor re: Teemu J. Murtola, Heimo Syvälä, Teemu Tolonen, et al. Atorvastatin Versus Placebo for Prostate Cancer Before Radical Prostatectomy-A Randomized, Double-blind, Placebo-controlled Clinical Trial. Eur Urol 2018;74:697-701.",,2019,,['Prostate Cancer'],"['Placebo', 'Atorvastatin Versus Placebo']",[],"[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]",[],,0.26218,,"[{'ForeName': 'Teemu J', 'Initials': 'TJ', 'LastName': 'Murtola', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland; Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland. Electronic address: teemu.murtola@uta.fi.'}, {'ForeName': 'Heimo', 'Initials': 'H', 'LastName': 'Syvälä', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riikonen', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}]",European urology,['10.1016/j.eururo.2019.01.044']
1975,25829908,Comparison between general anesthesia and spinal anesthesia in attenuation of stress response in laparoscopic cholecystectomy: A randomized prospective trial.,"BACKGROUND
Laparoscopy though minimally invasive produces significant hemodynamic surge and neuroendocrine stress response. Though general anesthesia (GA) is the conventional technique, now-a-days, regional anesthesia has been accepted for laparoscopic diagnostic procedures, and its use is also being extended to laparoscopic surgeries.
OBJECTIVE
The aim was to compare the hemodynamic surge and neuroendocrine stress response during laparoscopic cholecystectomy (LC) under GA and spinal anesthesia (SA) in American Society of Anesthesiologists (ASA) PS 1 patients.
MATERIALS AND METHODS
Thirty ASA physical status I patients, aged 18-65 years were randomly allocated into two equal groups of 15 each. Group A received GA with controlled ventilation. Patients were preoxygenated for 5 min with 100/5 oxygen, premedicated with midazolam 0.03 mg/kg intravenous (i.v), fentanyl 2 mcg/kg i.v; induction was done with thiopentone 3-5 mg/kg i.v; intubation was achieved after muscle relaxation with 0.5 mg/kg atracurium besylate i.v. Anesthesia was maintained with 1-2% sevoflurane and N2O:O2 (60:40) and intermittent i.v injection of atracurium besylate. Group B SA with 0.5% hyperbaric bupivacaine and 25 μg fentanyl along with local anesthetic instillation in the subdiaphragmatic space. Mean arterial pressure, heart rate (HR), oxygen saturation, end tidal carbon-dioxide were recorded. Venous blood was collected for cortisol assay before induction and 30 min after pneumoperitoneum. All data were collected in Microsoft excel sheet and statistically analyzed using SPSS software version 16 (SPSS Inc., Chicago, IL, USA). All numerical data were analyzed using Student's t-test and paired t-test. Any value <0.05 was taken as significant.
RESULTS
Mean arterial pressure and mean HR and postpneumoperitoneum cortisol level were lower in group B than group A though the difference was not statistically significant in hemodynamic parameters but significant in case of cortisol.
CONCLUSION
Spinal anesthesia administered for LC maintained comparable hemodynamics compared to GA and did not produce any ventilatory depression. It also produced less neuroendocrine stress response as seen by reduction in the level of serum cortisol in ASA PS 1 patients put for LC.",2015,"Mean arterial pressure and mean HR and postpneumoperitoneum cortisol level were lower in group B than group A though the difference was not statistically significant in hemodynamic parameters but significant in case of cortisol.
","['laparoscopic cholecystectomy', 'American Society of Anesthesiologists (ASA) PS 1 patients', 'I patients, aged 18-65 years', 'Thirty ASA physical status']","['laparoscopic cholecystectomy (LC) under GA and spinal anesthesia (SA', 'hyperbaric bupivacaine', 'general anesthesia and spinal anesthesia', 'midazolam 0.03 mg/kg intravenous (i.v), fentanyl 2 mcg/kg i.v; induction was done with thiopentone 3-5 mg/kg i.v; intubation was achieved after muscle relaxation with 0.5 mg/kg atracurium besylate i.v', 'sevoflurane and N2O:O2 (60:40) and intermittent i.v injection of atracurium besylate', 'GA with controlled ventilation', 'general anesthesia (GA']","['hemodynamic surge and neuroendocrine stress response', 'ventilatory depression', 'Mean arterial pressure, heart rate (HR), oxygen saturation, end tidal carbon-dioxide', 'Venous blood', 'neuroendocrine stress response', 'Mean arterial pressure and mean HR and postpneumoperitoneum cortisol level', 'hemodynamic parameters']","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517402', 'cui_str': '0.03 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0700323', 'cui_str': 'Neuromuscular block, function (observable entity)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0004235', 'cui_str': 'Atracurium Besylate'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.0517221,"Mean arterial pressure and mean HR and postpneumoperitoneum cortisol level were lower in group B than group A though the difference was not statistically significant in hemodynamic parameters but significant in case of cortisol.
","[{'ForeName': 'Writuparna', 'Initials': 'W', 'LastName': 'Das', 'Affiliation': 'Department of Anesthesiology, Burdwan Medical College, Burdwan, West Bengal, India.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Anesthesiology, Burdwan Medical College, Burdwan, West Bengal, India.'}, {'ForeName': 'Sarmila', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Department of Anesthesiology, Burdwan Medical College, Burdwan, West Bengal, India.'}, {'ForeName': 'Swarnamukul', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Department of Anesthesiology, Burdwan Medical College, Burdwan, West Bengal, India.'}, {'ForeName': 'Suchismita', 'Initials': 'S', 'LastName': 'Mallik', 'Affiliation': 'Department of Anesthesiology, Burdwan Medical College, Burdwan, West Bengal, India.'}, {'ForeName': 'Saswati', 'Initials': 'S', 'LastName': 'Pal', 'Affiliation': 'Department of Anesthesiology, N.R.S. Medical College, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.152881']
1976,25829910,Influence of GlideScope assisted endotracheal intubation on intraocular pressure in ophthalmic patients.,"BACKGROUND
Traditional Macintoch laryngoscopy is known to cause a rise in intraocular pressure (IOP), tachycardia and hypertension. These changes are not desirable in patients with glaucoma and open globe injury. GlideScope is a video laryngoscope that functions independent of the line of sight, reduces upward lifting forces for glottic exposure and requires less cervical neck movement for intubation, making it less stimulating than Macintosh laryngoscopy.
AIM
The aim was to assess the variations in IOP and hemodynamic changes after GlideScope assisted intubation.
MATERIALS AND METHODS
After approval of the local Institutional Research and Ethical Board and informed patient consent, 50 adult American Society of Anesthesiologist I and II patients with normal IOP were enrolled in a prospective, randomized study for ophthalmic surgery requiring tracheal intubation. In all patients, trachea was intubated using either GlideScope or Macintoch laryngoscope. IOP of nonoperated eye, heart rate and blood pressure were measured as baseline, 1 min after induction, 1 min and 5 min after tracheal intubation.
RESULTS
IOP was not significantly different between groups before and after anesthetic induction and 5 min after tracheal intubation (P = 0.217, 0.726, and 0.110 respectively). The only significant difference in IOP was at 1 min after intubation (P = 0.041). No significant difference noted between groups in mean arterial pressure (P = 0.899, 0.62, 0.47, 0.82 respectively) and heart rate (P = 0.21, 0.72, 0.07, 0.29, respectively) at all measurements.
CONCLUSION
GlideScope assisted tracheal intubation shown lesser rise in IOP at 1 min after intubation in comparison to Macintoch laryngoscope, suggesting that GlideScope may be preferable to Macintosh laryngoscope.",2015,"No significant difference noted between groups in mean arterial pressure (P = 0.899, 0.62, 0.47, 0.82 respectively) and heart rate (P = 0.21, 0.72, 0.07, 0.29, respectively) at all measurements.
","['ophthalmic patients', '50 adult American Society of Anesthesiologist I and II patients with normal IOP', 'patients with glaucoma and open globe injury']","['GlideScope or Macintoch laryngoscope', 'GlideScope assisted intubation', 'ophthalmic surgery requiring tracheal intubation', 'GlideScope', 'GlideScope assisted endotracheal intubation']","['intraocular pressure (IOP), tachycardia and hypertension', 'IOP', 'heart rate', 'mean arterial pressure', 'IOP and hemodynamic changes', 'intraocular pressure', 'IOP of nonoperated eye, heart rate and blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C3898098', 'cui_str': 'Open globe injury'}]","[{'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",50.0,0.279023,"No significant difference noted between groups in mean arterial pressure (P = 0.899, 0.62, 0.47, 0.82 respectively) and heart rate (P = 0.21, 0.72, 0.07, 0.29, respectively) at all measurements.
","[{'ForeName': 'Nauman', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': 'Department of Anesthesia, King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Zahoor', 'Affiliation': 'Department of Anesthesia, King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Riad', 'Affiliation': ""Department of Anesthesia, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Al Motowa', 'Affiliation': 'Department of Anterior Segment Division, King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.152885']
1977,32417102,"Corrigendum to ""Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes - A randomized controlled trial"" [Contemporary Clinical Trials 89 (2020) 105933].",,2020,,[],[],[],[],[],[],,0.05593,,"[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America. Electronic address: minalrp@umich.edu.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; Department of Internal Medicine, Michigan Medicine, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Hae Mi', 'Initials': 'HM', 'LastName': 'Choe', 'Affiliation': 'College of Pharmacy, University of Michigan, United States of America; University of Michigan Medical Group, United States of America.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Tobi', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106025']
1978,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND
No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).
MATERIALS AND METHODS
Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).
RESULTS
The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.
CONCLUSION
No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020']
1979,32417537,Dual X-ray absorptiometry has limited utility in detecting bone pathology in children with hypophosphatasia: A pooled post hoc analysis of asfotase alfa clinical trial data.,"Asfotase alfa is an enzyme replacement therapy approved for treatment of patients with pediatric-onset hypophosphatasia (HPP), a rare, inherited, systemic disease causing impaired skeletal mineralization, short stature, and reduced physical function in children. The role of dual X-ray absorptiometry (DXA) in the assessment of children with HPP has been insufficiently explored. This post hoc analysis included pooled DXA data from 2 open-label, multicenter studies in 19 children with HPP. The study population was aged ≥5 to <18 years and had received asfotase alfa for ≤6.6 years at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7]; treatment duration: 6.3 y [range: 0.1-6.6]. Baseline height Z-scores indicated short stature (median [min, max]: -1.26 [-6.6, 0]); mean [SD]: -2.30 [1.97]), thus requiring height adjustment of DXA Z-scores. At Baseline, few patients had height-adjusted bone mineral density (BMD ht ) Z-scores of -2 or less for whole body (n = 3) or lumbar spine (n = 5). In treated patients, mean whole body and lumbar spine BMD ht Z-scores did not change over time, but whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores increased significantly from Baseline to Last Assessment (P ≤ 0.0056). Improvements in Radiographic Global Impression of Change (RGI-C) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores. Improvements in Rickets Severity Score (RSS) correlated significantly with increases in lumbar spine BMD ht Z-scores and whole body BMC ht Z-scores (P < 0.05). No significant correlations were observed between any DXA and bone histomorphometry measure. These findings suggest that DXA BMD Z-scores, which are commonly used in clinical practice, have limited utility in assessing deficient bone mineralization in patients with HPP. Although BMC ht Z-scores increased significantly over time with asfotase alfa therapy, the lack of significant changes in more than one DXA parameter suggests that this tool may not be useful in everyday clinical practice. Furthermore, the use of BMC as an independent metric is not typical or recommended by guidelines. Complementary measures, such as skeletal radiographs supplemented with age-appropriate functional assessments, should be considered.",2020,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores.,"['patients with pediatric-onset hypophosphatasia (HPP', 'children with hypophosphatasia', 'The study population was aged ≥5 to <18\u202fyears and had received asfotase alfa for ≤6.6\u202fyears at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7];]; treatment duration: 6.3 y [range: 0.1-6.6', '19 children with HPP', 'patients with HPP', 'children with HPP']","['dual X-ray absorptiometry (DXA', 'Dual X-ray absorptiometry']","['BMC ht Z-scores', 'whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores', 'mean [SD', 'Rickets Severity Score (RSS', 'mean whole body and lumbar spine BMD ht Z-scores', 'Radiographic Global Impression of Change (RGIC) scale scores', 'DXA and bone histomorphometry measure', 'lumbar spine BMD ht Z-scores and whole body', 'height-adjusted bone mineral density (BMD ht ) Z-scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C0520739', 'cui_str': 'Hereditary pyropoikilocytosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",19.0,0.0447297,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores.,"[{'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Vanderbilt University, Village at Vanderbilt, 1500 21st Ave South, Suite 1514, Nashville, TN 37212, USA. Electronic address: jill.h.simmons@vumc.org.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Rush', 'Affiliation': ""Department of Pediatrics, Children's Mercy Kansas City, Adele Hall Campus, 2401 Gillham Rd, Kansas City, MO 64108, USA; University of Missouri - Kansas City School of Medicine, 2411 Holmes St, Kansas City, MO 64108, USA; University of Kansas School of Medicine, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: etrush@cmh.edu.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Petryk', 'Affiliation': 'Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210, USA. Electronic address: Anna.Petryk@alexion.com.'}, {'ForeName': 'Shanggen', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Clinical Development Services-Corporate, Covance, Inc., 210 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: shanggen.zhou@covance.com.'}, {'ForeName': 'Gabriel Á', 'Initials': 'GÁ', 'LastName': 'Martos-Moreno', 'Affiliation': 'Department of Endocrinology, Hospital Infantil Universitario Niño Jesús, IIS La Princesa, Av. de Menéndez Pelayo, 65, 28009 Madrid, Spain; Department of Pediatrics, Universidad Autónoma de Madrid, Calle Arzobispo Morcillo, 4, 28029 Madrid, Spain; CIBERobn, Instituto de Salud Carlos III, C/ Sinesio Delgado, 4, 28029 Madrid, Spain. Electronic address: gabrielangelmartos@yahoo.es.'}]",Bone,['10.1016/j.bone.2020.115413']
1980,31829912,Sequencing of Androgen-Deprivation Therapy With External-Beam Radiotherapy in Localized Prostate Cancer: A Phase III Randomized Controlled Trial.,"PURPOSE
Dose-escalated radiotherapy (RT) with androgen-deprivation therapy (ADT) is a standard definitive treatment of localized prostate cancer (LPCa). The optimal sequencing of these therapies is unclear. Our phase III trial compared neoadjuvant versus concurrent initiation of ADT in combination with dose-escalated prostate RT (PRT).
PATIENTS AND METHODS
Patients with newly diagnosed LPCa with Gleason score ≤ 7, clinical stage T1b to T3a, and prostate-specific antigen < 30 ng/mL were randomly allocated to neoadjuvant and concurrent ADT for 6 months starting 4 months before RT (neoadjuvant group) or concurrent and adjuvant ADT for 6 months starting simultaneously with RT (concurrent group). The primary end point was biochemical relapse-free survival (bRFS). Stratified log-rank test was used to compare bRFS and overall survival (OS). Incidence of grade ≥ 3 late RT-related toxicities was compared by log-rank test.
RESULTS
Overall, 432 patients were randomly assigned to the neoadjuvant (n = 215) or concurrent group (n = 217). At 10 years, bRFS rates for the two groups were 80.5% and 87.4%, respectively. Ten-year OS rates were 76.4% and 73.7%, respectively. There was no significant difference in bRFS ( P = .10) or OS ( P = .70) between the two groups. Relative to the neoadjuvant group, the hazard ratio for the concurrent group was 0.66 (95% CI, 0.41 to 1.07) for bRFS and 0.94 (95% CI, 0.68 to 1.30) for OS. No significant difference was observed in the 3-year incidence of late RT-related grade ≥ 3 GI (2.5% v 3.9%) or genitourinary toxicity (2.9% v 2.9%).
CONCLUSION
In our study, there was no statistically significant difference in bRFS between the two treatment groups. Similarly, no difference was seen in OS or late RT-related toxicities. On the basis of these results, both neoadjuvant and concurrent initiations of short-term ADT with dose-escalated PRT are reasonable standards of care for LPCa.",2020,There was no significant difference in bRFS ( P = .10) or OS ( P = .70) between the two groups.,"['Patients with newly diagnosed LPCa with Gleason score ≤ 7, clinical stage T1b to T3a, and prostate-specific antigen', 'localized prostate cancer (LPCa', 'Localized Prostate Cancer', '432 patients were randomly assigned to the neoadjuvant (n = 215) or concurrent group (n = 217']","['ADT', 'radiotherapy (RT) with androgen-deprivation therapy (ADT', 'Androgen-Deprivation Therapy With External-Beam Radiotherapy', 'RT (neoadjuvant group) or concurrent and adjuvant ADT', 'neoadjuvant and concurrent ADT']","['Incidence of grade ≥ 3 late RT-related toxicities', '3-year incidence of late RT-related grade ≥ 3 GI', 'bRFS', 'OS or late RT-related toxicities', 'bRFS and overall survival (OS', 'biochemical relapse-free survival (bRFS', 'bRFS rates', 'genitourinary toxicity', 'hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1136355', 'cui_str': 'BRFSS'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",432.0,0.0881589,There was no significant difference in bRFS ( P = .10) or OS ( P = .70) between the two groups.,"[{'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Soumyajit', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Choan', 'Initials': 'C', 'LastName': 'E', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'MacRae', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Perry', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bowen', 'Affiliation': 'Northeast Cancer Centre, Sudbury, Ontario, Canada.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Samant', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Morgan', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grimes', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01904']
1981,25829896,Conscious sedation for middle ear surgeries: A comparison between fentanyl-propofol and fentanyl-midazolam infusion.,"INTRODUCTION AND AIM
Middle ear surgeries can be performed under local anesthesia and sedation and can be well tolerated by the patient with minimal discomfort. This study was undertaken to compare two techniques of conscious sedation, intravenous midazolam, and propofol infusion for tympanoplasty.
MATERIALS AND METHODS
Forty patients scheduled for right or left tympanoplasty. American Society of Anesthesiologists I or II in age group 18-75 years were included in the study. The patients were randomly allocated into one of the two groups to receive either propofol (group I) or midazolam (group II).
RESULTS
The mean duration of anesthesia was 116.00 ± 33.94 min in group I, while 97.50 ± 30.76 min in group II (P = 0.07). The modified Ramsay sedation scale was not statistically significant in both the groups. In group I, 70% of the patients and 95% of the patients in group II had amnesia during the surgery (P = 0.091). The mean visual analog scale (VAS) score for surgeons and patients was not statistically significant in both the groups. In group I there was a positive correlation between the total dose of fentanyl and VAS score for surgeons (P = 0.02). There was also a positive correlation between the total dose of propofol and VAS score for surgeons (P = 0.034) and patients (P = 0.039) in group I.
CONCLUSION
Though propofol had shown a faster recovery and less nausea vomiting, we need a larger sample size to conclude, which of the technique is better. Both the techniques are safe, simple and versatile and provide excellent sedation with rapid trouble free recovery.",2015,"There was also a positive correlation between the total dose of propofol and VAS score for surgeons (P = 0.034) and patients (P = 0.039) in group I.
CONCLUSION
","['middle ear surgeries', 'American Society of Anesthesiologists', 'Forty patients scheduled for right or left tympanoplasty', 'I or II in age group 18-75 years were included in the study']","['midazolam', 'propofol', 'midazolam, and propofol infusion', 'Conscious sedation', 'fentanyl-propofol and fentanyl-midazolam infusion']","['VAS score', 'mean duration of anesthesia', 'nausea vomiting', 'modified Ramsay sedation scale', 'mean visual analog scale (VAS) score']","[{'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",40.0,0.0201842,"There was also a positive correlation between the total dose of propofol and VAS score for surgeons (P = 0.034) and patients (P = 0.039) in group I.
CONCLUSION
","[{'ForeName': 'Raghu S', 'Initials': 'RS', 'LastName': 'Thota', 'Affiliation': 'Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Ambardekar', 'Affiliation': 'Department of Anesthesia, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Priyamvada', 'Initials': 'P', 'LastName': 'Likhate', 'Affiliation': 'Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Mumbai, Maharashtra, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.152818']
1982,25829897,A randomized controlled prospective study comparing a low dose bupivacaine and fentanyl mixture to a conventional dose of hyperbaric bupivacaine for cesarean section.,"CONTEXT
Hormonal and mechanical factors make obstetric patients need strict dose calculations of local anesthetics intrathecally for spinal anesthesia. Any greater dose of local anesthetics can cause hemodynamic instability, maternal morbidity and any lesser dose can produce inadequate block. Hence, we hypothesized in our study that by using low dose of bupivacaine with fentanyl can maintain stable hemodynamics and provide better analgesia.
AIM
The aim was to compare the hemodynamics and duration of analgesia using a low dose (7.5 mg) bupivacaine fentanyl mixture to a conventional dose (10 mg) of hyperbaric bupivacaine for cesarean section.
SETTINGS AND DESIGN
Double-blinded, randomized, controlled prospective study was conducted at a tertiary academic hospital from 2008 to 2011.
MATERIALS AND METHODS
Fifty singleton parturient, scheduled for elective caesarean section were randomly allocated into two groups. Study group (group-S) received a combination of 25 μg fentanyl and 7.5 mg of hyperbaric bupivacaine, whereas the control group (group-C) received 10 mg of hyperbaric bupivacaine. Maternal hemodynamics, sensory and motor block, duration of analgesia and the Apgar score of the newborn were compared between the groups.
STATISTICAL ANALYSIS USED
Observational descriptive statistics, statistical package for social sciences (SPSS Inc. Released 2006, SPSS for Windows, Version 15.0. Chicago), paired t-test was used as applicable.
RESULTS
The blood pressure significantly decreased with >25% fall from the baseline in group-C (98.76 ± 8.36) than in group-S (117.32 ± 12.21) with P < 0.001. The duration of effective analgesia was significantly prolonged in the study group than in the control group (P < 0.001).
CONCLUSION
The combination of low dose bupivacaine and fentanyl in comparison to bupivacaine alone is hemodynamically stable and prolonged duration of analgesia in caesarean section.",2015,"The duration of effective analgesia was significantly prolonged in the study group than in the control group (P < 0.001).
","['Fifty singleton parturient, scheduled for elective caesarean section', 'tertiary academic hospital from 2008 to 2011', 'cesarean section']","['combination of 25 μg fentanyl and 7.5 mg of hyperbaric bupivacaine', 'hyperbaric bupivacaine', 'bupivacaine with fentanyl', 'bupivacaine and fentanyl', 'bupivacaine', 'bupivacaine fentanyl mixture', 'bupivacaine and fentanyl mixture']","['blood pressure', 'duration of effective analgesia', 'Maternal hemodynamics, sensory and motor block, duration of analgesia and the Apgar score of the newborn']","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]",,0.0647572,"The duration of effective analgesia was significantly prolonged in the study group than in the control group (P < 0.001).
","[{'ForeName': 'Himabindu Gandam', 'Initials': 'HG', 'LastName': 'Venkata', 'Affiliation': 'Department of Anesthesiology and Critical Care, Gandhi Medical College/Hospital, Secunderabad, Telangana, India.'}, {'ForeName': 'Surender', 'Initials': 'S', 'LastName': 'Pasupuleti', 'Affiliation': 'Department of Anesthesiology and Critical Care, Gandhi Medical College/Hospital, Secunderabad, Telangana, India.'}, {'ForeName': 'Upender Gowd', 'Initials': 'UG', 'LastName': 'Pabba', 'Affiliation': 'Department of Anesthesiology and Critical Care, Gandhi Medical College/Hospital, Secunderabad, Telangana, India.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Porika', 'Affiliation': 'Department of Anesthesiology and Critical Care, Gandhi Medical College/Hospital, Secunderabad, Telangana, India.'}, {'ForeName': 'Goutham', 'Initials': 'G', 'LastName': 'Talari', 'Affiliation': 'Department of Internal Medicine, University of Kentucky, Lexington, Kentucky, USA.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.152827']
1983,25846982,Race/Ethnicity and Treatment Outcome in a Randomized Controlled Trial for Trichotillomania (Hair-Pulling Disorder).,"OBJECTIVE
Treatment outcome was compared among non-Hispanic White and racial/ethnic minority participants with trichotillomania (TTM), or hair-pulling disorder.
METHOD
Symptom severity, quality of life, and TTM-related disability were compared in a behavior therapy trial with a stepped care approach: web-based self-help and then individual behavior therapy. The sample comprised 72% (n = 38) non-Hispanic White participants and 28% (n = 15) minority participants.
RESULTS
The ethnic groups responded differently to treatment, with fewer minority participants showing improvement during web-based self-help. Response rates were equivalent between ethnic groups during the in-person behavior therapy. These results should be interpreted with caution because of the small sample size of minorities in the study and consequent inability to analyze results for each racial/ethnic group individually.
CONCLUSIONS
Future studies should focus on the investigation of factors that may enable or hinder racial and ethnic minority participants to benefit from online and/or self-help behavior therapy for TTM.",2015,Response rates were equivalent between ethnic groups during the in-person behavior therapy.,"['The sample comprised 72% (n = 38) non-Hispanic White participants and 28% (n = 15) minority participants', 'Hair-Pulling Disorder', 'non-Hispanic White and racial/ethnic minority participants with trichotillomania (TTM), or hair-pulling disorder']",['Trichotillomania'],"['Response rates', 'Symptom severity, quality of life, and TTM-related disability']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}]","[{'cui': 'C0040953', 'cui_str': 'Trichotillomania'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",38.0,0.0837517,Response rates were equivalent between ethnic groups during the in-person behavior therapy.,"[{'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Falkenstein', 'Affiliation': 'American University.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'American University.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Malloy', 'Affiliation': 'American University.'}, {'ForeName': 'David A F', 'Initials': 'DA', 'LastName': 'Haaga', 'Affiliation': 'American University.'}]",Journal of clinical psychology,['10.1002/jclp.22171']
1984,32417634,"Supplemental selenium and coenzyme Q10 reduce glycation along with cardiovascular mortality in an elderly population with low selenium status - A four-year, prospective, randomised, double-blind placebo-controlled trial.","BACKGROUND
A low intake of selenium has been shown to increase the risk of cardiovascular mortality, and supplementation of selenium and coenzyme Q10 influences this. The mechanism behind is unclear although effects on inflammation, oxidative stress and microRNA expression have been reported. Fructosamine, a marker of long-term glycaemic control, is also a marker of increased risk of heart disease and death, even in non-diabetics.
OBJECTIVE
To analyse the impact of selenium and coenzyme Q10 supplementation on the concentration of fructosamine. Also, the relation between pre-intervention serum selenium concentration and the effect on fructosamine of the intervention was studied.
METHODS
Fructosamine plasma concentration was determined in 219 participants after six and 42 months of intervention with selenium yeast (200 μg/day) and coenzyme Q10 (200 mg/ day) (n = 118 of which 20 had diabetes at inclusion), or placebo (n = 101 of which 18 had diabetes at inclusion). Pre-intervention, the serum selenium levels were 67 μg/L (active treatment group: 66.6 μg/L; placebo group: 67.4 μg/L), corresponding to an estimated intake of 35 μg/day. Changes in concentrations of fructosamine following intervention were assessed by the use of T-tests, repeated measures of variance, and ANCOVA analyses.
RESULTS
Post-intervention selenium concentrations were 210 μg/L in the active group and 72 μg/L in the placebo group. A lower concentration of fructosamine could be seen as a result of the intervention in the total population (P = 0.001) in both the males (P = 0.04) and in the females (P = 0.01) in the non-diabetic population (P = 0.002), and in both the younger (<76 years) (P = 0.01) and the older (≥76 years) participants (P = 0.03). No difference could be demonstrated in fructosamine concentration in the diabetic patients, but the total sample was small (n = 38). In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
CONCLUSION
A significantly lower concentration of fructosamine was observed in the elderly community-living participants supplemented with selenium and coenzyme Q10 for 42 months compared to those on the placebo. As oxidative mechanisms are involved in the glycation of proteins, less glycoxidation could be a result of the supplementation of selenium and coenzyme Q10, which could have contributed to lower cardiac mortality and less inflammation, as has earlier been reported. This study was registered at Clinicaltrials.gov, and has the identifier NCT01443780.",2020,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
","['219 participants after six and 42 months of intervention with selenium yeast (200\u202fμg/day) and', 'elderly population with low selenium status - A four-year', '\u202f101 of which 18 had diabetes at inclusion']","['Fructosamine', 'selenium and coenzyme Q10', 'coenzyme Q10 ', 'selenium and coenzyme Q10 supplementation', 'placebo (n', 'Supplemental selenium and coenzyme Q10 reduce glycation', 'placebo']","['serum selenium levels', 'fructosamine', 'concentration of fructosamine', 'fructosamine concentration']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0455308', 'cui_str': 'Serum selenium measurement'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",219.0,0.328184,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
","[{'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Alehagen', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University, SE-581 85 Linköping, Sweden. Electronic address: Urban.Alehagen@liu.se.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aaseth', 'Affiliation': 'Research Department, Innlandet Hospital Trust, N-2381 Brumunddal, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Alexander', 'Affiliation': 'Norwegian Institute of Public Health, P.O. Box 222 Skøyen, N-0213 Oslo, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johansson', 'Affiliation': 'Department of Social and Welfare studies. Department of Medical and Health Sciences, Linköping University, SE-601 74 Norrköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, SE-751 85 Uppsala, Sweden.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126541']
1985,25994742,Culprit lesion thrombus burden after manual thrombectomy or percutaneous coronary intervention-alone in ST-segment elevation myocardial infarction: the optical coherence tomography sub-study of the TOTAL (ThrOmbecTomy versus PCI ALone) trial.,"AIMS
Manual thrombectomy has been proposed as a strategy to reduce thrombus burden during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). However, the effectiveness of manual thrombectomy in reducing thrombus burden is uncertain. In this substudy of the TOTAL (ThrOmbecTomy versus PCI ALone) trial, we compared the thrombus burden at the culprit lesion using optical coherence tomography (OCT) in patients treated with thrombectomy vs. PCI-alone.
METHODS AND RESULTS
The TOTAL trial (N = 10 732) was an international, multicentre, randomized trial of thrombectomy (using the Export catheter, Medtronic Cardiovascular, Santa Rosa, CA, USA) in STEMI patients treated with primary PCI. The OCT substudy prospectively enrolled 214 patients from 13 sites in 5 countries. Optical coherence tomography was performed immediately after thrombectomy or PCI-alone and then repeated after stent deployment. Thrombus quantification was performed by an independent core laboratory blinded to treatment assignment. The primary outcome of pre-stent thrombus burden as a percentage of segment analysed was 2.36% (95% CI: 1.73-3.22) in the thrombectomy group and 2.88% (95% CI: 2.12-3.90) in the PCI-alone group (P = 0.373). Absolute pre-stent thrombus volume was not different (2.99 vs. 3.74 mm(3), P = 0.329). Other secondary outcomes of pre-stent quadrants of thrombus, post-stent atherothrombotic burden, and post-stent atherothrombotic volume were not different between groups.
CONCLUSION
Manual thrombectomy did not reduce pre-stent thrombus burden at the culprit lesion compared with PCI-alone. Both strategies were associated with low thrombus burden at the lesion site after the initial intervention to restore flow.",2015,"Absolute pre-stent thrombus volume was not different (2.99 vs. 3.74 mm(3), P = 0.329).","['patients with ST-segment elevation myocardial infarction (STEMI', 'patients treated with thrombectomy vs. PCI-alone', '214 patients from 13 sites in 5 countries', 'ST-segment elevation myocardial infarction']","['primary PCI', 'manual thrombectomy or percutaneous coronary intervention-alone', 'optical coherence tomography (OCT']","['pre-stent thrombus burden as a percentage of segment analysed', 'Absolute pre-stent thrombus volume', 'pre-stent quadrants of thrombus, post-stent atherothrombotic burden, and post-stent atherothrombotic volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",214.0,0.185623,"Absolute pre-stent thrombus volume was not different (2.99 vs. 3.74 mm(3), P = 0.329).","[{'ForeName': 'Ravinay', 'Initials': 'R', 'LastName': 'Bhindi', 'Affiliation': 'Royal North Shore Hospital, Sydney, and University of Sydney, Sydney, Australia.'}, {'ForeName': 'Olli A', 'Initials': 'OA', 'LastName': 'Kajander', 'Affiliation': 'Heart Hospital, Tampere University Hospital and School of Medicine, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Sanjit S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, David Braley Cardiac, Vascular, and Stroke Research Institute, 237 Barton St E, Hamilton, ON, Canada L8L 2X4.'}, {'ForeName': 'Saleem', 'Initials': 'S', 'LastName': 'Kassam', 'Affiliation': 'Rouge Valley Health System Centenary, Cardiac Care Program, Toronto, ON, Canada.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Lavi', 'Affiliation': 'Department of Cardiology, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Niemelä', 'Affiliation': 'Heart Hospital, Tampere University Hospital and School of Medicine, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fung', 'Affiliation': 'Division of Cardiology, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Asim N', 'Initials': 'AN', 'LastName': 'Cheema', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Meeks', 'Affiliation': 'Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, David Braley Cardiac, Vascular, and Stroke Research Institute, 237 Barton St E, Hamilton, ON, Canada L8L 2X4.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'Cardiology Department, Patras University Hospital, Patras, Greece.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kočka', 'Affiliation': 'Medicine, Charles University in Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Cantor', 'Affiliation': 'Southlake Regional Health Centre, University of Toronto, Newmarket, ON, Canada.'}, {'ForeName': 'Timo P', 'Initials': 'TP', 'LastName': 'Kaivosoja', 'Affiliation': 'Heart Hospital, Tampere University Hospital and School of Medicine, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Shestakovska', 'Affiliation': 'Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, David Braley Cardiac, Vascular, and Stroke Research Institute, 237 Barton St E, Hamilton, ON, Canada L8L 2X4.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, David Braley Cardiac, Vascular, and Stroke Research Institute, 237 Barton St E, Hamilton, ON, Canada L8L 2X4.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Stankovic', 'Affiliation': 'Department of Cardiology, Clinical Center of Serbia, and Medical Faculty, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Džavík', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Tej', 'Initials': 'T', 'LastName': 'Sheth', 'Affiliation': 'Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, David Braley Cardiac, Vascular, and Stroke Research Institute, 237 Barton St E, Hamilton, ON, Canada L8L 2X4 shetht@mcmaster.ca.'}]",European heart journal,['10.1093/eurheartj/ehv176']
1986,25829901,Response to low-dose intrathecal clonidine in septuagenarians undergoing sub-umbilical surgeries: A study.,"UNLABELLED
Clonidine, an alpha-2-adrenergic agonist, may have a clinically relevant analgesic action but also a hypotensive action, when administered spinally.
AIM
To evaluate the analgesic and circulatory effects of low-dose intrathecal clonidine co-administered with hyperbaric bupivacaine in septuagenarian patients undergoing sub-umbilical surgeries.
MATERIALS AND METHODS
A total of 20 patients within the age group of 70-80 years of either sex, enrolled in this study, were randomly divided into groups of 10 each. Group I received clonidine 7.5 μg as an adjuvant to 15 mg of hyperbaric bupivacaine and Group II (control group) received 15 mg of bupivacaine with saline to make volume in the two solutions equal.
RESULT
The level of subarachnoid block was comparable in the two groups. Duration of motor blockade was longer in the clonidine group (221.4 ± 35.92 min) compared with the control group (112.3 ± 12.45 min). Request for 1(st) dose of analgesic was earlier in the control group (135.5 ± 28.52 min) than the clonidine group (295 ± 18.85 min). Mean arterial pressure (clonidine 77.67 ± 6.47 vs. control 93.87 ± 3.03, P = 0.0002) and heart rate (clonidine 65.2 ± 5.20 vs. control 77.4 ± 6.06, P = 0.003) were significantly lower (P < 0.05) in the clonidine group compared with the control group from 20 mins after the block to the end of 3 h. In the clonidine group, 3 patients had postoperative headache, 4 had intra-operative shivering. 2 patients in the clonidine group also developed hypotension and 1 bradycardia and 1 of them developed bradyapnea along with acute hypotension 5 min after shifting to the postoperative ward and later recovered on resuscitation. In the control group 2 patients had bradycardia, 6 had intra-operative shivering and 3 had postoperative headache.
CONCLUSION
We conclude that addition of clonidine in the dose of 7.5 μg to bupivacaine significantly increases the duration of spinal analgesia with clinically insignificant influence on hemodynamic parameters.",2015,"Mean arterial pressure (clonidine 77.67 ± 6.47 vs. control 93.87 ± 3.03, P = 0.0002) and heart rate (clonidine 65.2 ± 5.20 vs. control 77.4 ± 6.06, P = 0.003) were significantly lower (P < 0.05) in the clonidine group compared with the control group from 20 mins after the block to the end of 3 h.","['septuagenarians undergoing sub-umbilical surgeries', '20 patients within the age group of 70-80 years of either sex', 'septuagenarian patients undergoing sub-umbilical surgeries']","['bupivacaine with saline', 'clonidine 7.5 μg as an adjuvant to 15 mg of hyperbaric bupivacaine', 'low-dose intrathecal clonidine', 'low-dose intrathecal clonidine co-administered with hyperbaric bupivacaine', 'bupivacaine', 'clonidine', 'Clonidine']","['intra-operative shivering', 'duration of spinal analgesia', 'postoperative headache', 'heart rate', 'level of subarachnoid block', 'hypotension and 1 bradycardia', 'Duration of motor blockade', 'hemodynamic parameters', 'analgesic and circulatory effects', 'bradycardia, 6 had intra-operative shivering', 'Mean arterial pressure']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",20.0,0.0497354,"Mean arterial pressure (clonidine 77.67 ± 6.47 vs. control 93.87 ± 3.03, P = 0.0002) and heart rate (clonidine 65.2 ± 5.20 vs. control 77.4 ± 6.06, P = 0.003) were significantly lower (P < 0.05) in the clonidine group compared with the control group from 20 mins after the block to the end of 3 h.","[{'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Sen', 'Affiliation': 'Department of Anesthesia, Goldfield Institute of Medical Sciences and Research, Ballabgargh, Faridabad, India.'}, {'ForeName': 'Bitan', 'Initials': 'B', 'LastName': 'Sen', 'Affiliation': 'Department of Emergency Medicine, Apollo Hospital, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.152840']
1987,25829902,Dexmedetomidine as an adjuvant to ropivacaine in supraclavicular brachial plexus block.,"CONTEXT
Dexmedetomidine as an adjuvant to local anesthetics in peripheral nerve blocks has been used in only a few studies.
AIMS
We aimed at assessing the effect of dexmedetomidine as an adjuvant to ropivacaine in supraclavicular brachial plexus block.
SETTINGS AND DESIGN
Random, controlled, and triple blind.
MATERIALS AND METHODS
Sixty American Society of Anesthesiologist grade I and II patients of either sex scheduled for elective upper limb surgery under supraclavicular brachial plexus block were divided into three equal groups in a prospective randomized double-blind controlled manner. For block patients in Group C received 0.5% ropivacaine (30cc), 0.5% ropivacaine with 50 μg dexmedetomidine (30cc) in Group D and 0.5% ropivacaine (30cc) in Group D-IV along with intravenous infusion of 50 μg dexmedetomidine in normal saline.
STATISTICAL ANALYSIS USED
IBM-SPSS software version 17, Chi-square test, Mann-Whitney U-test.
RESULTS
Demographic profile and surgical characteristics were similar in all the three groups. Sensory block and motor block onset was earlier in group D than in group D-IV and group C. The sensory block and motor block duration was also prolonged in group D when compared with group D-IV and group C. The duration of analgesia was significantly longer in group D and D-IV when compared to group C.
CONCLUSIONS
Dexmedetomidine as an adjuvant to 0.5%ropivacaine in ultrasound guided brachial plexus block shortens the sensory as well as motor block onset time, prolongs sensory and motor block duration and also increases the duration of analgesia. The action of dexmedetomidine most probably is local rather than centrally mediated.",2015,The sensory block and motor block duration was also prolonged in group D when compared with group D-IV and group C.,"['Sixty American Society of Anesthesiologist grade', 'I and II patients of either sex scheduled for elective upper limb surgery under supraclavicular brachial plexus block', 'supraclavicular brachial plexus block']","['Dexmedetomidine', '0.5%ropivacaine', 'dexmedetomidine (30cc) in Group D and 0.5% ropivacaine', 'ropivacaine', 'ropivacaine (30cc), 0.5% ropivacaine', 'dexmedetomidine']","['sensory block and motor block duration', 'duration of analgesia', 'Sensory block and motor block onset']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach (procedure)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",60.0,0.0741232,The sensory block and motor block duration was also prolonged in group D when compared with group D-IV and group C.,"[{'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Kathuria', 'Affiliation': 'Department of Anesthesia. Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesia. Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Dhawan', 'Affiliation': 'Department of Anesthesia. Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.152841']
1988,25829905,"Comparison of intraoperative brain condition, hemodynamics and postoperative recovery between desflurane and sevoflurane in patients undergoing supratentorial craniotomy.","BACKGROUND
Post operative recovery has been reported to be faster with desflurane than sevoflurane anesthesia in previous studies. The use of desflurane is often criticized in neurosurgery due to the concerns of cerebral vasodilation and increase in ICP and studies comparing desflurane and sevoflurane in neurosurgey are scarce. So we compared the intraoperative brain condition, hemodynamics and postoperative recovery in patients undergoing elective supratentorial craniotomy receiving either desflurane or sevoflurane.
MATERIALS AND METHODS
Fifty three patients between 18-60yr undergoing elective supratentorial craniotomy receiving N2O and oxygen (60%:40%) and 0.8-1.2 MAC of either desflurane or sevoflurane were randomized to group S (Sevoflurane) or group D (Desflurane). Subdural intra cranial pressure (ICP) was measured and brain condition was assessed.. Emergence time, tracheal extubation time and recovery time were recorded. Cognitive behavior was evaluated with Short Orientation Memory Concentration Test (SOMCT) and neurological outcome (at the time of discharge) was assessed using Glasgow Outcome Score (GOS) between the two groups.
RESULTS
The emergence time [Group D 7.4 ± 2.7 minutes vs. Group S 7.8 ± 3.7 minutes; P = 0.65], extubation time [Group D 11.8 ± 2.8 minutes vs. Group S 12.9 ± 4.9 minutes; P = 0.28] and recovery time [Group D 16.4 ± 2.6 minutes vs. Group S 17.1 ± 4.8 minutes; P = 0.50] were comparable between the two groups. There was no difference in ICP [Group D; 9.1 ± 4.3 mmHg vs. Group S; 10.9 ± 4.2 mmHg; P = 0.14] and brain condition between the two groups. Both groups had similar post-operative complications, hospital and ICU stay and GOS.
CONCLUSION
In patients undergoing elective supratentorial craniotomy both sevoflurane and desflurane had similar intra-operative brain condition, hemodynamics and post operative recovery profile.",2015,"In patients undergoing elective supratentorial craniotomy both sevoflurane and desflurane had similar intra-operative brain condition, hemodynamics and post operative recovery profile.","['patients undergoing elective supratentorial craniotomy receiving either', 'patients undergoing elective supratentorial craniotomy both', 'Fifty three patients between 18-60yr undergoing elective supratentorial craniotomy receiving N2O and oxygen (60%:40%) and 0.8-1.2 MAC of either', 'patients undergoing supratentorial craniotomy']","['desflurane', 'sevoflurane and desflurane', 'desflurane and sevoflurane', 'desflurane or sevoflurane', 'sevoflurane anesthesia', 'group S (Sevoflurane) or group D (Desflurane']","['Cognitive behavior', 'extubation time', 'similar post-operative complications, hospital and ICU stay and GOS', 'Emergence time, tracheal extubation time and recovery time', 'Subdural intra cranial pressure (ICP', 'brain condition', 'similar intra-operative brain condition, hemodynamics and post operative recovery profile', 'Glasgow Outcome Score (GOS', 'recovery time', 'Short Orientation Memory Concentration Test (SOMCT) and neurological outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451474', 'cui_str': 'Short orientation - memory - concentration test (assessment scale)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",53.0,0.0856716,"In patients undergoing elective supratentorial craniotomy both sevoflurane and desflurane had similar intra-operative brain condition, hemodynamics and post operative recovery profile.","[{'ForeName': 'Surya Kumar', 'Initials': 'SK', 'LastName': 'Dube', 'Affiliation': 'Department of Neuroanesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Mihir Prakash', 'Initials': 'MP', 'LastName': 'Pandia', 'Affiliation': 'Department of Neuroanesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Neuroanesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Parmod', 'Initials': 'P', 'LastName': 'Bithal', 'Affiliation': 'Department of Neuroanesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Hari Hara', 'Initials': 'HH', 'LastName': 'Dash', 'Affiliation': 'Department of Anesthesiology, Fortis Memorial Research Institute, Gurgaon, Haryana, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.152866']
1989,25829907,A comparative evaluation of the effect of intravenous dexmedetomidine and clonidine on intraocular pressure after suxamethonium and intubation.,"BACKGROUND
In patients with penetrating eye injury and a full stomach, suxamethonium is still used for rapid sequence induction of anesthesia. But its use is associated with the rise in intraocular pressure (IOP) and this can result in permanent vision loss in these patients. Dexmedetomidine and clonidine are two alpha-2 adrenergic agonist drugs which prevent the rise in IOP. The aim of this study is to compare the efficacy of intravenous (i.v.) dexmedetomidine and clonidine in preventing an increase in IOP after administration of suxamethonium and tracheal intubation.
MATERIALS AND METHODS
Sixty patients undergoing elective nonophthalmic surgery under general anesthesia were included in this clinical study. Patients were randomly assigned into three groups to receive 0.5 mcg/kg dexmedetomidine (Group D), 2 mcg/kg clonidine (Group C) or normal saline (Group S) as premedication i.v. over a period of 10 min before induction. IOP, heart rate, and mean arterial pressure were recorded before and after premedication, after suxamethonium, after intubation and then after 5 min.
RESULTS
Following administration of dexmedetomidine and clonidine IOP decreased in both groups. After suxamethonium IOP increased in all three groups but it never crossed the baseline in Group D and C. After laryngoscopy and intubation IOP again increased in all three groups but in dexmedetomidine group it never crossed the baseline whereas in clonidine group it was significantly higher than the baseline.
CONCLUSION
Single i.v. dose of dexmedetomidine premedication (0.5 mcg/kg) blunt the IOP and hemodynamic response to suxamethonium injection and tracheal intubation more effectively than single i.v. dose of clonidine premedication (2 mcg/kg).",2015,"After laryngoscopy and intubation IOP again increased in all three groups but in dexmedetomidine group it never crossed the baseline whereas in clonidine group it was significantly higher than the baseline.
","['Sixty patients undergoing elective nonophthalmic surgery under general anesthesia', 'patients with penetrating eye injury and a full stomach']","['dexmedetomidine and clonidine', 'dexmedetomidine premedication', 'normal saline', 'suxamethonium injection and tracheal intubation', 'Dexmedetomidine', 'suxamethonium', 'clonidine', 'suxamethonium and intubation', 'clonidine IOP', 'clonidine premedication', 'dexmedetomidine']","['intubation IOP again', 'IOP', 'IOP, heart rate, and mean arterial pressure', 'intraocular pressure (IOP', 'intraocular pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0015409', 'cui_str': 'Eye Injuries, Penetrating'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",60.0,0.187397,"After laryngoscopy and intubation IOP again increased in all three groups but in dexmedetomidine group it never crossed the baseline whereas in clonidine group it was significantly higher than the baseline.
","[{'ForeName': 'Puneet K', 'Initials': 'PK', 'LastName': 'Banga', 'Affiliation': 'Department of Anesthesiology and Critical Care, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Dhananjay K', 'Initials': 'DK', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesiology and Critical Care, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Dadu', 'Affiliation': 'Department of Anesthesiology and Critical Care, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Community Medicine, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.152878']
1990,31548238,"Naturalistic Audio-Movies and Narrative Synchronize ""Visual"" Cortices across Congenitally Blind But Not Sighted Individuals.","How does developmental experience, as opposed to intrinsic physiology, shape cortical function? Naturalistic stimuli were used to elicit neural synchrony in individuals blind from birth ( n = 18) and those who grew up with sight ( n = 18). Blind and blindfolded sighted participants passively listened to three audio-movie clips, an auditory narrative, a sentence shuffled version of the narrative (maintaining language but lacking a plotline), and a version of the narrative backward (lacking both language and plot). For both groups, early auditory cortices were synchronized to a similar degree across stimulus types, whereas higher-cognitive temporoparietal and prefrontal areas were more synchronized by meaningful, temporally extended stimuli (i.e., audio movies and narrative). ""Visual"" cortices were more synchronized across blind than sighted individuals, but only for audio-movies and narrative. In the blind group, visual cortex synchrony was low for backward speech and intermediate for sentence shuffle. Meaningful auditory stimuli synchronize visual cortices of people born blind. SIGNIFICANCE STATEMENT Naturalistic stimuli engage cognitive processing at many levels. Here, we harnessed this richness to investigate the effect of experience on cortical function. We find that listening to naturalistic audio movies and narrative drives synchronized activity across ""visual"" cortices of blind, more so than sighted, individuals. Visual cortex synchronization varies with meaningfulness and cognitive complexity. Higher synchrony is observed for temporally extended meaningful stimuli (e.g., movies/narrative), intermediate for shuffled sentences, lowest for time varying complex noise. By contrast, auditory cortex was synchronized equally by meaningful and meaningless stimuli. In congenitally blind individuals most of visual cortex is engaged by meaningful naturalistic stimuli.",2019,"""Visual"" cortices were more synchronized across blind than sighted individuals, but only for audio-movies and narrative.","['people born blind', 'individuals blind from birth (n=18) and those who grew up with sight (n=18', 'sighted individuals']","['Naturalistic auditory stories synchronize ""visual"" cortices', 'blindfolded sighted participants passively listened to three audio-movie clips, an auditory narrative, a sentence shuffled version of the narrative (maintaining language but lacking a plotline), and a version of the narrative backwards (lacking both language and plot']","['auditory cortex', 'Visual"" cortices', 'visual"" cortex synchrony']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0560464', 'cui_str': 'Does shuffle (finding)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}]","[{'cui': 'C0004302', 'cui_str': 'Temporal Auditory Area'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",,0.024925,"""Visual"" cortices were more synchronized across blind than sighted individuals, but only for audio-movies and narrative.","[{'ForeName': 'Rita E', 'Initials': 'RE', 'LastName': 'Loiotile', 'Affiliation': 'Johns Hopkins University, Department of Psychological and Brain Sciences, Baltimore, Maryland 21218, and.'}, {'ForeName': 'Rhodri', 'Initials': 'R', 'LastName': 'Cusack', 'Affiliation': 'Trinity College Institute of Neuroscience and School of Psychology, Trinity College Dublin, Dublin 2, Ireland.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bedny', 'Affiliation': 'Johns Hopkins University, Department of Psychological and Brain Sciences, Baltimore, Maryland 21218, and marina.bedny@jhu.edu.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0298-19.2019']
1991,32425361,"Efficacy and Safety of Lianhuaqingwen Capsules, a repurposed Chinese Herb, in Patients with Coronavirus disease 2019: A multicenter, prospective, randomized controlled trial.","Background
Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza.
Purpose
To determine the safety and efficacy of LH capsule in patients with Covid-19.
Methods
We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery.
Results
We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, P =0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, P <0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all P <0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, P <0.001) and clinical cure (78.9% vs. 66.2%, P= 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both P >0.05). No serious adverse events were reported.
Conclusion
In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.",2020,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, P <0.001) and clinical cure (78.9% vs. 66.2%, P= 0.017) was also higher in treatment group.","['patients with Covid-19', '284 patients (142 each in treatment and control group) in the full-analysis set', 'Patients with Coronavirus disease 2019']","['LH capsule', 'Lianhuaqingwen Capsules, a repurposed Chinese Herb', 'usual treatment alone or in combination with LH capsules']","['Efficacy and Safety', 'rate of improvement in chest computed tomographic manifestations', 'coughing', 'Time to recovery of fever', 'fatigue', 'rate of symptom (fever, fatigue, coughing) recovery', 'rate of conversion to severe cases or viral assay findings', 'clinical cure', 'safety and efficacy', 'serious adverse events', 'median time to symptom recovery', 'recovery rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3852361', 'cui_str': 'lianhuaqingwen'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",284.0,0.213016,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, P <0.001) and clinical cure (78.9% vs. 66.2%, P= 0.017) was also higher in treatment group.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Guan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province,510120, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Gynaecology and Obstetrics, Wuhan Red Cross Hospital, 392 Hongkong Road, Wuhan 430015, Hubei province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of College of Medicine, Zhejiang province, China.'}, {'ForeName': 'Boli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'The First Teaching Hospital of Tianjin University of traditional Chinese medicine.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Beijing Hospital of traditional Chinese medicine, Beijing, China.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Ditan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Youan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Shanghai University of traditional Chinese medicine, Shanghai, China.'}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province,510120, P.R. China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province,510120, P.R. China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Fuyang Second People's Hospital, Fuyang, China.""}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, Hubei province, China.'}, {'ForeName': 'Chaomin', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Jia', 'Affiliation': 'Hebei Yiling Hospital, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, Hebei province 050035, P.R China.'}, {'ForeName': 'Nan-Shan', 'Initials': 'NS', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province,510120, P.R. China.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153242']
1992,25422600,Intracuff alkalized lidocaine reduces sedative/analgesic requirements for mechanically ventilated patients.,"BACKGROUND
The objective of this study is to investigate the effect of intracuff alkalized lidocaine on sedative/analgesic requirements for mechanically ventilated patients and its consequence on patient-ventilator interaction.
MATERIALS AND METHODS
A total of 64 patients who expected to require ventilatory support for a period of more than 48 h were randomly assigned to groups S and L. In group S, the endotracheal tube (ETT) cuffs were inflated with normal saline. In group L, the ETT cuffs were inflated with lidocaine 2% and sodium bicarbonate 8.4%. The investigator and the surgical intensive care unit staff were blinded to the nature of cuff-filled solutions. Sedation was maintained with propofol and fentanyl infusions. The total requirements for propofol and fentanyl, frequency and severity of cough and number of ineffective triggering during the first 24 h of mechanical ventilation were recorded.
RESULTS
There was a significant reduction (about 30%) in the requirements for propofol and fentanyl in patients who received intracuff alkalinized lidocaine; P < 0.001. The frequency and severity of cough were significantly lower in group L compared with group S and the frequency of ineffective triggering was significantly lower in group L; P < 0.001 for both comparisons.
CONCLUSION
Intracuff alkalized lidocaine increases ETT tolerance and hence, decreases sedatives/analgesics requirements for mechanically ventilated patients. This results in improved patient-ventilator synchronization.",2014,There was a significant reduction (about 30%) in the requirements for propofol and fentanyl in patients who received intracuff alkalinized lidocaine; P < 0.001.,"['mechanically ventilated patients and its consequence on patient-ventilator interaction', 'mechanically ventilated patients', '64 patients who expected to require ventilatory support for a period of more than 48 h']","['lidocaine', 'sodium bicarbonate', 'Intracuff alkalized lidocaine', 'propofol', 'intracuff alkalized lidocaine', 'endotracheal tube (ETT) cuffs were inflated with normal saline', 'intracuff alkalinized lidocaine']","['ETT tolerance and hence, decreases sedatives/analgesics requirements', 'frequency of ineffective triggering', 'patient-ventilator synchronization', 'sedative/analgesic requirements', 'frequency and severity of cough', 'total requirements for propofol and fentanyl, frequency and severity of cough and number of ineffective triggering']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff, device (physical object)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",64.0,0.0263784,There was a significant reduction (about 30%) in the requirements for propofol and fentanyl in patients who received intracuff alkalinized lidocaine; P < 0.001.,"[{'ForeName': 'Ahmed Sobhy', 'Initials': 'AS', 'LastName': 'Basuni', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Tanta University, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140816']
1993,25422601,"Prevention of altered hemodynamics after spinal anesthesia: A comparison of volume preloading with tetrastarch, succinylated gelatin and ringer lactate solution for the patients undergoing lower segment caesarean section.","BACKGROUND
Spinal anesthesia has replaced general anesthesia in obstetric practice. Hemodynamic instability is a common, but preventable complication of spinal anesthesia. Preloading the circulation with intravenous fluids is considered a safe and effective method of preventing hypotension following spinal anesthesia. We had conducted a study to compare the hemodynamic stability after volume preloading with either Ringer's lactate (RL) or tetrastarch hydroxyethyl starch (HES) or succinylated gelatin (SG) in the patients undergoing cesarean section under spinal anesthesia.
MATERIALS AND METHODS
It was a prospective, double-blinded and randomized controlled study. Ninety six ASA-I healthy, nonlaboring parturients were randomly divided in 3 groups HES, SG, RL (n = 32 each) and received 10 ml/kg HES 130/0.4; 10 ml/kg SG (4% modified fluid gelatin) and 20 ml/kg RL respectively prior to SA scheduled for cesarean section. Heart rate, blood pressure (BP), oxygen saturation was measured.
RESULTS
The fall in systolic blood pressure (SBP) (<100 mm Hg) noted among 5 (15.63%), 12 (37.5%) and 14 (43.75%) parturients in groups HES, SG, RL respectively. Vasopressor (phenylephrine) was used to treat hypotension when SBP <90 mm Hg. Both the results and APGAR scores were comparable in all the groups. Lower preloading volume and less intra-operative vasopressor requirement was noted in HES group for maintaining BP though it has no clinical significance.
CONCLUSION
RL which is cheap, physiological and widely available crystalloid can preload effectively and maintain hemodynamic stability well in cesarean section and any remnant hypotension can easily be manageable with vasopressor.",2014,"The fall in systolic blood pressure (SBP) (<100 mm Hg) noted among 5 (15.63%), 12 (37.5%) and 14 (43.75%) parturients in groups HES, SG, RL respectively.","['Ninety six ASA', 'altered hemodynamics after spinal anesthesia', 'patients undergoing lower segment caesarean section', 'patients undergoing cesarean section under spinal anesthesia', 'I healthy, nonlaboring parturients']","['Vasopressor (phenylephrine', ""Ringer's lactate (RL) or tetrastarch hydroxyethyl starch (HES) or succinylated gelatin (SG"", 'tetrastarch, succinylated gelatin and ringer lactate solution', '10 ml/kg HES 130/0.4; 10 ml/kg SG (4% modified fluid gelatin) and 20 ml/kg RL respectively prior to SA scheduled for cesarean section']","['hemodynamic stability', 'Lower preloading volume and less intra-operative vasopressor requirement', 'systolic blood pressure (SBP', 'Heart rate, blood pressure (BP), oxygen saturation', 'APGAR scores']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0195620', 'cui_str': 'Low cervical cesarean section (procedure)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C1816356', 'cui_str': 'Product containing tetrastarch'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0143961', 'cui_str': 'succinylated gelatin'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0128811', 'cui_str': 'modified fluid gelatins'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}]",96.0,0.0698988,"The fall in systolic blood pressure (SBP) (<100 mm Hg) noted among 5 (15.63%), 12 (37.5%) and 14 (43.75%) parturients in groups HES, SG, RL respectively.","[{'ForeName': 'Tapobrata', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Bangur Institute of Neurology, Kolkata, West Bengal, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Rahul Deb', 'Initials': 'RD', 'LastName': 'Mandal', 'Affiliation': 'Department G and O, Burdwan Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Bimal Kumar', 'Initials': 'BK', 'LastName': 'Hajra', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140817']
1994,32425482,Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes.,"Objectives
We aim to evaluate our policy of index admission management of gall bladder empyema and the effect of the timing of surgery on the outcomes.
Methods
We analyzed a series of 5400 laparoscopic cholecystectomies. Data were collected prospectively over 26 y. Patients were divided into two groups: group 1, intervention within 72 h, and group 2, intervention after 72 h of admission. We had a policy of intention to treat during the index admission, but delays sometimes occurred because of late referral, a need to optimize patients, availability of theater time, or the biliary surgeon being on leave. The groups were then compared with regard to the duration of surgery, the difficulty grading, complications, hospital stay, and conversion rate.
Results
A total of 372 patients were included; 160 (43%) operated on within 72 h (group 1) and 212 (57%) after 72 h (group 2). There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate. The difference in total hospital stay was, however, statistically significant.
Conclusion
Surgical management of empyema should be offered as soon as possible after admission as with any acute cholecystitis. Surgery carried out after 72 h of admission is only associated with longer hospital stay but no statistically significant differences in other outcome parameters. In the presence of specialist expertise, fitness for surgery should be the determining factor of whether or not to offer surgery to these patients, regardless of the interval since their admission.",2020,"There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate.","['5400 laparoscopic cholecystectomies', 'Gall Bladder Empyema', 'A total of 372 patients were included; 160 (43%) operated on within 72 h (group 1) and 212 (57%) after 72 h (group 2']",[],"['difficulty grading, complications, hospital stay, and conversion rate', 'longer hospital stay', 'operation time, conversion rate, and complications rate', 'total hospital stay']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0014012', 'cui_str': 'Empyema of gallbladder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]",[],"[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",372.0,0.051755,"There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate.","[{'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'El Zanati', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Ahmad H M', 'Initials': 'AHM', 'LastName': 'Nassar', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Zino', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Katbeh', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Hwei Jene', 'Initials': 'HJ', 'LastName': 'Ng', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abdellatif', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00015']
1995,25558193,Modified sevoflurane-based sedation technique versus propofol sedation technique: A randomized-controlled study.,"BACKGROUND
The aim of this study was to evaluate the safety and efficacy of sevoflurane-based sedation technique for colonoscopy in geriatric patients as compared with that using propofol.
MATERIALS AND METHODS
Sixty elderly patients, who were scheduled for colonoscopy, participated in this controlled prospective study and were randomly allocated into two groups; P and S. The patients were sedated using either propofol in P group or sevoflurane in S group. Complications (including apnea, the need for airway intervention, occurrence of general anesthesia [GA], hemodynamic instability and others), the fentanyl requirement and the times of the procedure, recovery, and discharge were recorded in both groups.
RESULTS
The patients in P group had more frequent apnea attacks, need for airway intervention and occurrence of GA compared to the patients in S group. However, both groups were comparable regarding the other measured variables.
CONCLUSION
For geriatric colonoscopy, sevoflurane can provide safe and effective sedation alternative to propofol.",2015,"The patients in P group had more frequent apnea attacks, need for airway intervention and occurrence of GA compared to the patients in S group.","['geriatric patients', 'Sixty elderly patients, who were scheduled for']","['propofol in P group or sevoflurane', 'For geriatric colonoscopy', 'colonoscopy', 'Modified sevoflurane-based sedation technique versus propofol sedation technique', 'propofol', 'sevoflurane', 'sevoflurane-based sedation technique']","['safety and efficacy', 'frequent apnea attacks, need for airway intervention and occurrence of GA', 'Complications (including apnea, the need for airway intervention, occurrence of general anesthesia [GA], hemodynamic instability and others), the fentanyl requirement and the times of the procedure, recovery, and discharge']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0474454', 'cui_str': 'Apneic attack'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",60.0,0.0191576,"The patients in P group had more frequent apnea attacks, need for airway intervention and occurrence of GA compared to the patients in S group.","[{'ForeName': 'Mohamed Ibrahim', 'Initials': 'MI', 'LastName': 'Syaed El Ahl', 'Affiliation': 'Department of Anesthesia, Burjeel Hospital, Abu Dhabi, UAE ; Lecturer of Anesthesia, Anesthesia Department, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.146265']
1996,25558198,Effect of low dose tranexamic acid on intra-operative blood loss in neurosurgical patients.,"BACKGROUND
Blood loss is often a major complication in neurosurgery that requires transfusion of multiple units of blood. The purpose of this study was to assess the effect of tranexamic acid (TXA) on intraoperative blood loss and the need for blood transfusion in patients undergoing craniotomy for tumor excision.
MATERIALS AND METHODS
A total of 100 patients aged 18-60 years, with American Society of Anesthesiologists physical Status 1 and 2 scheduled to undergo elective craniotomy for tumor excision were enrolled. Patients received 10 mg/kg bolus about 20 min before skin incision followed by 1 mg/kg/h infusion of either TXA or saline. Hemodynamic variables, intravenous fluid transfused, amount of blood loss and blood given were measured every 2 h. Laboratory parameters such as serum electrolytes and fibrinogen values were measured every 3 h. On the 5(th) postoperative day hemoglobin (POD Hb5), Hb estimation was done and the estimated blood loss (EBL) calculated. Patients were also monitored for any complications.
RESULTS
The Mean heart rate in TXA group was significantly lower compared with the saline group. Mean arterial pressure and fibrinogen levels were higher in TXA group. The mean total blood loss in the TXA group was less than in the saline group. Blood transfusion requirements were comparable in two groups. The EBL and POD5 Hb were comparable in two groups.
CONCLUSION
Even though, there is a significant reduction in the total amount of blood loss in TXA group. However, there was no reduction in intraoperative transfusion requirement.",2015,Mean arterial pressure and fibrinogen levels were higher in TXA group.,"['100 patients aged 18-60 years, with American Society of Anesthesiologists physical Status 1 and 2 scheduled to undergo elective craniotomy for tumor excision were enrolled', 'patients undergoing craniotomy for tumor excision', 'neurosurgical patients']","['TXA or saline', 'tranexamic acid', 'tranexamic acid (TXA']","['intraoperative transfusion requirement', 'Hemodynamic variables, intravenous fluid transfused, amount of blood loss and blood given', 'serum electrolytes and fibrinogen values', 'Mean heart rate', 'total amount of blood loss', 'Mean arterial pressure and fibrinogen levels', 'mean total blood loss', 'Blood transfusion requirements', 'intraoperative blood loss', 'intra-operative blood loss']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1299802', 'cui_str': 'Excision of neoplasm'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0005768'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen measurement'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",100.0,0.0794965,Mean arterial pressure and fibrinogen levels were higher in TXA group.,"[{'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Vel', 'Affiliation': 'Department of Anesthesiology and Critical Care, JIPMER, Puducherry, India.'}, {'ForeName': 'Bidkar Prasanna', 'Initials': 'BP', 'LastName': 'Udupi', 'Affiliation': 'Department of Anesthesiology and Critical Care, JIPMER, Puducherry, India.'}, {'ForeName': 'Munaganuri Venkata Siva', 'Initials': 'MV', 'LastName': 'Satya Prakash', 'Affiliation': 'Department of Anesthesiology and Critical Care, JIPMER, Puducherry, India.'}, {'ForeName': 'Sethuramachandran', 'Initials': 'S', 'LastName': 'Adinarayanan', 'Affiliation': 'Department of Anesthesiology and Critical Care, JIPMER, Puducherry, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Anesthesiology and Critical Care, JIPMER, Puducherry, India.'}, {'ForeName': 'Lenin', 'Initials': 'L', 'LastName': 'Babu', 'Affiliation': 'Department of Anesthesiology and Critical Care, JIPMER, Puducherry, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.146304']
1997,25558199,"Is the World Health Organization-recommended dose of pralidoxime effective in the treatment of organophosphorus poisoning? A randomized, double-blinded and placebo-controlled trial.","BACKGROUND
Organophosphorus poisoning (OPP) is a major global public health problem. Pralidoxime has been used in a complimentary role to atropine for the management of OPP. World Health Organization (WHO) recommends use of pralidoxime but studies regarding its role have been inconclusive, ranging from being ineffective to harmful or beneficial.
MATERIALS AND METHODS
The present study was undertaken to evaluate the effectiveness of pralidoxime. Eddleston's study was the most compelling factor for our study, as he showed worst outcomes using pralidoxime. Our practice of continuous use of pralidoxime was based on the WHO guidelines and the study by Pawar (2006), which showed better outcome with higher doses of pralidoxime. These conflicting results suggested that a re-evaluation of its use in our clinical practice was indicated.
RESULTS
There was no difference in mortality rates, hemodynamic parameters and atropine requirements between the AP and A groups. Mean duration of ventilation (3.6 ± 4.6 in AP group vs. 3.6 ± 4.4 in A group) and Intensive Care Unit stay (7.1 ± 5.4 in AP group vs. 6.8 ± 4.7 in A group) was comparable. Serum sodium concentrations showed a correlation with mortality, with lower concentrations associated with better outcomes.
CONCLUSION
The study suggests that add-on WHO-recommended pralidoxime therapy does not provide any benefit over atropine monotherapy. Adding pralidoxime does not seem to be beneficial and at the same time does not result in increased mortality rates. Our practice changed after completion of this study, and it has proven to be of significant benefit to patients who had to bear the expense of treatment.",2015,"There was no difference in mortality rates, hemodynamic parameters and atropine requirements between the AP and A groups.","['Organophosphorus poisoning (OPP', 'patients who had to bear the expense of treatment']","['placebo', 'pralidoxime', 'Pralidoxime', 'pralidoxime therapy', 'atropine']","['mortality rates, hemodynamic parameters and atropine requirements', 'mortality rates', 'Intensive Care Unit stay', 'Serum sodium concentrations', 'Mean duration of ventilation']","[{'cui': 'C0353676', 'cui_str': 'Organophosphorus Poisoning'}, {'cui': 'C0911329', 'cui_str': 'OPP'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0071808', 'cui_str': 'pralidoxime'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}]","[{'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]",,0.11027,"There was no difference in mortality rates, hemodynamic parameters and atropine requirements between the AP and A groups.","[{'ForeName': 'Sumaya', 'Initials': 'S', 'LastName': 'Syed', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sheri Kashmir Institute of Medical Sciences, Soura, Srinagar, Kashmir, India.'}, {'ForeName': 'Showkat Ahmad', 'Initials': 'SA', 'LastName': 'Gurcoo', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sheri Kashmir Institute of Medical Sciences, Soura, Srinagar, Kashmir, India.'}, {'ForeName': 'Ayaz Khalid', 'Initials': 'AK', 'LastName': 'Farooqui', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sheri Kashmir Institute of Medical Sciences, Soura, Srinagar, Kashmir, India.'}, {'ForeName': 'Waqarul', 'Initials': 'W', 'LastName': 'Nisa', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sheri Kashmir Institute of Medical Sciences, Soura, Srinagar, Kashmir, India.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Sofi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sheri Kashmir Institute of Medical Sciences, Soura, Srinagar, Kashmir, India.'}, {'ForeName': 'Tariq M', 'Initials': 'TM', 'LastName': 'Wani', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Nationwide Children's Hospital, Columbus, Ohio, USA.""}]",Saudi journal of anaesthesia,['10.4103/1658-354X.146306']
1998,25558200,Comparison of efficacy of three subanesthetic doses of ketamine in allaying procedural discomfort during establishment of subarachnoid block: A randomized double-blind trial.,"BACKGROUND
Procedural discomfort is experienced by patients during the establishment of subarachnoid block even after good preoperative counseling and adequate premedication. To enhance comfort, procedural sedation that would provide good analgesia, faster recovery, and amnesia is necessary.
MATERIALS AND METHODS
Patients with American Society of Anesthesiologists Status I and II posted for elective surgeries under subarachnoid block were premedicated with injection midazolam 0.05 mg/kg and preloaded with 10 ml/kg ringer lactate solution. They were randomized into three groups of 30 each. Group K0.3 received ketamine 0.3 mg/kg, Group K0.4 received ketamine 0.4 mg/kg and Group K0.5 received ketamine 0.5 mg/kg intravenously. University of Michigan sedation score, ease of positioning, prick response, verbal response, hallucinations, recall of procedure, and patient satisfaction were evaluated.
RESULTS
There was statistically significant difference in sedation among the three groups. Increased dose necessitated help of two persons to position the patient, which showed statistically significant difference. Verbal response was seen early in Group K0.3 (4.67 ± 2.84 min). There was no recall of experience of subarachnoid block procedure in any of the groups in spite of back muscle contraction or patient movement. Hence, all patients in all three groups were satisfied and were willing to undergo subarachnoid block, if the situation arises.
CONCLUSION
Ketamine in the dose of 0.3 mg/kg provided sufficient sedation for allaying procedural discomfort due to less sedation, less positional difficulty, early verbal response, no hallucinations, no recall of performance of procedure, and good patient satisfaction.",2015,There was no recall of experience of subarachnoid block procedure in any of the groups in spite of back muscle contraction or patient movement.,"['Patients with American Society of Anesthesiologists', 'subarachnoid block']","['Ketamine', 'injection midazolam 0.05 mg/kg and preloaded with 10 ml/kg ringer lactate solution', 'ketamine 0.4 mg/kg and Group K0.5 received ketamine 0.5 mg/kg intravenously', 'ketamine']","['positional difficulty, early verbal response, no hallucinations, no recall of performance of procedure, and good patient satisfaction', 'recall of experience of subarachnoid block procedure', 'sedation', 'Verbal response', 'University of Michigan sedation score, ease of positioning, prick response, verbal response, hallucinations, recall of procedure, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}]",,0.165129,There was no recall of experience of subarachnoid block procedure in any of the groups in spite of back muscle contraction or patient movement.,"[{'ForeName': 'V R Hemanth', 'Initials': 'VR', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'Umesh Kumar', 'Initials': 'UK', 'LastName': 'Athiraman', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'Sameer M', 'Initials': 'SM', 'LastName': 'Jahagirdar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sripriya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Parthasarathy', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ravishankar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.146307']
1999,25538514,Topical airway anesthesia for awake fiberoptic intubation: Comparison between airway nerve blocks and nebulized lignocaine by ultrasonic nebulizer.,"OVERVIEW
Awake fiberoptic bronchoscope (FOB) guided intubation is the gold standard of airway management in patients with cervical spine injury. It is essential to sufficiently anesthetize the upper airway before the performance of awake FOB guided intubation in order to ensure patient comfort and cooperation. This randomized controlled study was performed to compare two methods of airway anesthesia, namely ultrasonic nebulization of local anesthetic and performance of airway blocks.
MATERIALS AND METHODS
A total of 50 adult patients with cervical spine injury were randomly allocated into two groups. Group L received airway anesthesia through ultrasonic nebulization of 10 ml of 4% lignocaine and Group NB received airway blocks (bilateral superior laryngeal and transtracheal recurrent laryngeal) each with 2 ml of 2% lignocaine and viscous lignocaine gargles. FOB guided orotracheal intubation was then performed. Hemodynamic variables at baseline and during the procedure, patient recall, vocal cord visibility, ease of intubation, coughing/gagging episodes, and signs of lignocaine toxicity were noted.
RESULTS
The observations did not reveal any significant differences in demographics or hemodynamic parameters at any time during the study. However, the time taken for intubation was significantly lower in Group NB as compared with the Group L. Group L had an increased number of coughing/gagging episodes as compared with Group NB. Vocal cord visibility and ease of intubation were better in patients who received airway blocks and hence the amount of supplemental lignocaine used was less in this group. Overall patient comfort was better in Group NB with fewer incidences of unpleasant recalls as compared with Group L.
CONCLUSION
Upper airway blocks provide better quality of anesthesia than lignocaine nebulization as assessed by patient recall of procedure, coughing/gagging episodes, ease of intubation, vocal cord visibility, and time taken to intubate.",2014,"Overall patient comfort was better in Group NB with fewer incidences of unpleasant recalls as compared with Group L.
CONCLUSION
Upper airway blocks provide better quality of anesthesia than lignocaine nebulization as assessed by patient recall of procedure, coughing/gagging episodes, ease of intubation, vocal cord visibility, and time taken to intubate.","['awake fiberoptic intubation', '50 adult patients with cervical spine injury', 'patients with cervical spine injury']","['nebulized lignocaine', 'lignocaine', 'FOB guided orotracheal intubation', 'Topical airway anesthesia', 'Awake fiberoptic bronchoscope (FOB) guided intubation', 'airway anesthesia through ultrasonic nebulization of 10 ml of 4% lignocaine and Group NB received airway blocks (bilateral superior laryngeal and transtracheal recurrent laryngeal) each with 2 ml of 2% lignocaine and viscous lignocaine gargles']","['patient recall, vocal cord visibility, ease of intubation, coughing/gagging episodes, and signs of lignocaine toxicity', 'Overall patient comfort', 'time taken for intubation', 'demographics or hemodynamic parameters', 'number of coughing/gagging episodes', 'Vocal cord visibility and ease of intubation', 'patient recall of procedure, coughing/gagging episodes, ease of intubation, vocal cord visibility, and time taken to intubate']","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope (physical object)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0442387', 'cui_str': 'Transtracheal approach (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",50.0,0.0391322,"Overall patient comfort was better in Group NB with fewer incidences of unpleasant recalls as compared with Group L.
CONCLUSION
Upper airway blocks provide better quality of anesthesia than lignocaine nebulization as assessed by patient recall of procedure, coughing/gagging episodes, ease of intubation, vocal cord visibility, and time taken to intubate.","[{'ForeName': 'Babita', 'Initials': 'B', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology and Intensive Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Santvana', 'Initials': 'S', 'LastName': 'Kohli', 'Affiliation': 'Department of Anesthesiology and Intensive Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Farooque', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Jalwal', 'Affiliation': 'Department of Anesthesiology and Intensive Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Chandralekha', 'Affiliation': 'Department of Anesthesiology and Intensive Care, All India Institute of Medical Sciences, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.144056']
2000,25538518,"Patient-controlled sedation with propofol/remifentanil versus propofol/alfentanil for patients undergoing outpatient colonoscopy, a randomized, controlled double-blind study.","CONTEXT
Many techniques are used for sedation of colonoscopies. Patient-controlled sedation (PCS) is utilizing many drugs or drug combinations.
AIMS
The aim of this study is to compare the safety and feasibility of propofol/remifentanil versus propofol/alfentanil given to sedate patients undergoing outpatient colonoscopies through a patient-controlled technique.
SETTINGS AND DESIGN
Controlled randomized and double-blind study.
MATERIALS AND METHODS
A total of 80 patients were randomly divided into two groups; PA group received a combination of propofol/alfentanil and PR group received propofol/remifentanil combination. Patients were monitored for heart rate (HR), blood pressure (BP), oxygen saturation, and Ramsay sedation scale (RSS). Times of the following events were recorded; initiation of sedation, insertion and removal of the colonoscope, recovery and discharge. Five intervals were calculated; time to sedation, procedure time, postprocedure time, procedure room time, and postanesthesia care unit (PACU) time. Endoscopist and patient satisfaction scores were obtained.
STATISTICAL ANALYSIS USED
Unpaired Student's t-test was used to compare between the two groups. Paired Student's t-test was used to compare baseline readings with readings after 30 min of sedation in the same group when needed.
RESULTS
Both groups showed slowing of the HR and decrease in mean arterial BP. HR and mean arterial BP were significantly lower 5 and 10 min after initiation of sedation in PR group when compared with PA group. Both HR and mean arterial BP returned to presedation readings 30 min after initiation of sedation in PR group but not in PA group. No differences between the two groups concerning oxygen saturation, RSS, endoscopist and patient satisfaction scores. Postprocedure and PACU times were significantly prolonged in PA group.
CONCLUSION
PCS with either remifentanil/propofol or alfentanil/propofol for patients undergoing outpatient colonoscopy is safe and feasible. Remifentanil/proofol has more beneficial advantages in this setting secondary to its more rapid clearance.",2014,HR and mean arterial BP were significantly lower 5 and 10 min after initiation of sedation in PR group when compared with PA group.,"['80 patients', 'patients undergoing outpatient colonoscopy', 'sedate patients undergoing outpatient colonoscopies through a patient-controlled technique']","['Patient-controlled sedation (PCS', 'propofol/alfentanil and PR group received propofol/remifentanil combination', 'remifentanil/propofol or alfentanil/propofol', 'propofol/alfentanil', 'propofol/remifentanil', 'Remifentanil/proofol']","['time to sedation, procedure time, postprocedure time, procedure room time, and postanesthesia care unit (PACU) time', 'Postprocedure and PACU times', 'Endoscopist and patient satisfaction scores', 'heart rate (HR), blood pressure (BP), oxygen saturation, and Ramsay sedation scale (RSS', 'safety and feasibility', 'mean arterial BP', 'HR and mean arterial BP', 'oxygen saturation, RSS, endoscopist and patient satisfaction scores', 'initiation of sedation, insertion and removal of the colonoscope, recovery and discharge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C2699011', 'cui_str': 'Really Simple Syndication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0180022', 'cui_str': 'Colonoscopes'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",80.0,0.0301253,HR and mean arterial BP were significantly lower 5 and 10 min after initiation of sedation in PR group when compared with PA group.,"[{'ForeName': 'Sherif S', 'Initials': 'SS', 'LastName': 'Sultan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.144068']
2001,32425222,[Repurposing chlorpromazine to treat COVID-19: the reCoVery study].,"OBJECTIVES
The ongoing COVID-19 pandemic has caused approximately 2,350,000 infections worldwide and killed more than 160,000 individuals. In Sainte Anne Hospital (GHU PARIS Psychiatrie & Neuroscience, Paris, France) we have observed a lower incidence of symptomatic forms of COVID-19 among patients than among our clinical staff. This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties. Chlorpromazine (CPZ), a phenothiazine derivative, is also known for its antiviral activity via the inhibition of clathrin-mediated endocytosis. Recent in vitro studies have reported that CPZ exhibits anti-MERS-CoV and anti-SARS-CoV-1 activity.
METHODS
In this context, the ReCoVery study aims to repurpose CPZ, a molecule with an excellent tolerance profile and a very high biodistribution in the saliva, lungs and brain. We hypothesize that CPZ could reduce the unfavorable course of COVID-19 infection among patients requiring respiratory support without the need for ICU care, and that it could also reduce the contagiousness of SARS-CoV-2. For this purpose, we plan a pilot, multicenter, randomized, single blind, controlled, phase III therapeutic trial (standard treatment vs. CPZ + standard treatment).
CONCLUSION
This repurposing of CPZ for its anti-SARS-CoV-2 activity could offer an alternative, rapid strategy to alleviate infection severity. This repurposing strategy also avoids numerous developmental and experimental steps, and could save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easily managed side effects.",2020,"This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties.",[],"['Chlorpromazine (CPZ', 'chlorpromazine', 'phenothiazine derivative', 'CPZ', 'CPZ + standard treatment']",[],[],"[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0585347,"This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties.","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}, {'ForeName': 'Anne-Cécile', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 Evolutionary Genomics of RNA Viruses, Paris, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': 'Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.05.006']
2002,25538527,"Effect of dexmedetomidine as adjuvant in ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded and randomized controlled study.","BACKGROUND AND AIMS
Different additives have been used to prolong brachial plexus block. We evaluated the effect of adding dexmedetomidine to ropivacaine for supraclavicular brachial plexus blockade. The primary endpoints were the onset and duration of sensory and motor block and duration of analgesia.
MATERIALS AND METHODS
A total of 84 patients (20-50 years) posted for elective forearm and hand surgery under supraclavicular brachial plexus block were divided into two equal groups (Group R and RD) in a randomized, double-blind fashion. In group RD (n = 42) 30 ml 0.5% ropivacaine +1 ml (100 μg) of dexmedetomidine and group R (n = 42) 30 ml 0.5% ropivacaine +1 ml normal saline were administered in supraclavicular block. Sensory and motor block onset times and block durations, time to first analgesic use, total analgesic need, postoperative visual analog scale (VAS), hemodynamics and side-effects were recorded for each patient.
RESULTS
Though with similar demographic profile in both groups, sensory and motor block in group RD (P < 0.05) was earlier than group R. Sensory and motor block duration and time to first analgesic use were significantly longer and the total need for rescue analgesics was lower in group RD (P < 0.05) than group R. Post-operative VAS value at 12 h were significantly lower in group RD (P < 0.05). Intra-operative hemodynamics were significantly lower in group RD (P < 0.05) without any appreciable side-effects.
CONCLUSION
It can be concluded that adding dexmedetomidine to supraclavicular brachial plexus block increases the sensory and motor block duration and time to first analgesic use, and decreases total analgesic use with no side-effects.",2014,"Intra-operative hemodynamics were significantly lower in group RD (P < 0.05) without any appreciable side-effects.
","['induced supraclavicular brachial plexus block', 'supraclavicular brachial plexus blockade', '84 patients (20-50 years) posted for elective forearm and hand surgery under supraclavicular brachial plexus block']","['ropivacaine', 'ropivacaine +1 ml normal saline', 'dexmedetomidine']","['operative VAS value', 'motor block duration and time to first analgesic use', 'Sensory and motor block onset times and block durations, time to first analgesic use, total analgesic need, postoperative visual analog scale (VAS), hemodynamics and side-effects', 'onset and duration of sensory and motor block and duration of analgesia', 'total need for rescue analgesics', 'sensory and motor block', 'Intra-operative hemodynamics']","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach (procedure)'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach (qualifier value)'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",84.0,0.0858076,"Intra-operative hemodynamics were significantly lower in group RD (P < 0.05) without any appreciable side-effects.
","[{'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine & Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Susanta', 'Initials': 'S', 'LastName': 'Halder', 'Affiliation': 'Department of Anaesthesiology, R. G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Surajit', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of Anaesthesiology, Bankura Sammilani Medical College, Bankura, West Bengal, India.'}, {'ForeName': 'Saswati', 'Initials': 'S', 'LastName': 'Pal', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Ratul', 'Initials': 'R', 'LastName': 'Kundu', 'Affiliation': 'Department of Anaesthesiology, Institute of Post Graduate Medical Education And Research, Kolkata, West Bengal, India.'}, {'ForeName': 'Subrata Kumar', 'Initials': 'SK', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesiology, College of Medicine & Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of G & O, College of Medicine & Sagore Dutta Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.144082']
2003,25538528,"The efficacy of adding dexamethasone, midazolam, or epinephrine to 0.5% bupivacaine in supraclavicular brachial plexus block.","AIMS
The aim was to assess the effectiveness of adding either dexamethasone or midazolam in comparison with epinephrine addition to 0.5% bupivacaine in supraclavicular brachial plexus block.
SETTINGS AND DESIGN
This is a prospective randomized controlled observer-blinded study.
SUBJECTS AND METHODS
This study was carried out in Tanta University Hospital on 60 patients of both sexes; American Society of Anesthesiologists physical Status I and II, age range from 18 to 45 years undergo elective surgery to upper limb. All patients were anesthetized with ultrasound guided supraclavicular brachial plexus block and randomly divided into three groups (each group 20 patients) Group E (epinephrine): 30 mL bupivacaine 0.5%with 1:200,000 epinephrine (5 μg/mL). Group D (dexamethasone): 30 mL bupivacaine 0.5% and dexamethasone 8 mg. Group M (midazolam): 30 ml bupivacaine 0.5% and midazolam 50 μg/kg. The primary outcome measures were onset and duration of sensory and motor block and time to first analgesic request.
STATISTICAL ANALYSIS USED
The windows version of SPSS 11.0.1 (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. Data were presented in form of mean ± standard deviation multiple analysis of variance (ANOVA) was used to compare the three groups and Scheffe test was used after ANOVA. Power of significance P < 0.05 was considered to be statistically significant.
RESULTS
Onset of sensory and motor block was significantly rapid (P < 0.05) in Groups D and M in comparison with Group E. Time of administration of rescue analgesic, duration of sensory and motor block showed significant increase (P < 0.05) in Group D in comparison with Group M which showed significant increase (P < 0.05) in comparison with Group E.
CONCLUSIONS
In comparison with epinephrine and midazolam addition of dexamethasone to bupivacaine had rapid onset of block and longer time to first analgesic request with fewer side-effects.",2014,"RESULTS
Onset of sensory and motor block was significantly rapid (P < 0.05) in Groups D and M in comparison with Group E. Time of administration of rescue analgesic, duration of sensory and motor block showed significant increase (P < 0.05) in Group D in comparison with Group M which showed significant increase (P < 0.05) in comparison with Group E.
CONCLUSIONS
","['All patients were anesthetized with ultrasound guided supraclavicular brachial plexus block and randomly divided into three groups (each group 20 patients', 'Tanta University Hospital on 60 patients of both sexes; American Society of Anesthesiologists physical Status I and II, age range from 18 to 45 years undergo elective surgery to upper limb', 'supraclavicular brachial plexus block']","['dexamethasone or midazolam', 'Group M (midazolam', 'epinephrine', 'dexamethasone', 'epinephrine and midazolam', 'midazolam', 'bupivacaine 0.5%with 1:200,000 epinephrine', 'bupivacaine', 'dexamethasone, midazolam, or epinephrine to 0.5% bupivacaine', 'Group D (dexamethasone): 30 mL bupivacaine']","['rapid onset of block and longer time to first analgesic request', 'onset and duration of sensory and motor block and time to first analgesic request', 'rescue analgesic, duration of sensory and motor block']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach (procedure)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",60.0,0.106819,"RESULTS
Onset of sensory and motor block was significantly rapid (P < 0.05) in Groups D and M in comparison with Group E. Time of administration of rescue analgesic, duration of sensory and motor block showed significant increase (P < 0.05) in Group D in comparison with Group M which showed significant increase (P < 0.05) in comparison with Group E.
CONCLUSIONS
","[{'ForeName': 'Ghada F', 'Initials': 'GF', 'LastName': 'El-Baradey', 'Affiliation': 'Department of Anesthesia and ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Nagat S', 'Initials': 'NS', 'LastName': 'Elshmaa', 'Affiliation': 'Department of Anesthesia and ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.144083']
2004,25538526,"Postoperative nausea and vomiting prophylaxis: A comparative study of ondansetron, granisetron and granisetron and dexamethasone combination after modified radical mastectomy.","BACKGROUND
Post-operative nausea and vomiting (PONV) is commonly seen after modified radical mastectomy (MRM). In this randomized double-blind prospective study we compared the efficacy of ondansetron, granisetron and granisetron and dexamethasone combination for prevention of PONV following MRM in female patients.
MATERIALS AND METHODS
A total of 75 patients (20-60 years of age) undergoing elective MRM were randomly allocated to one of the three groups of 25 patients each. Group O received ondansetron 4 mg, Group G received granisetron 40 mcg/kg and group granisetron and dexamethasone (G + D) received granisetron 40 mcg/kg + dexamethasone 8 mg prior to induction. All episodes of PONV within 24 h after induction of anesthesia were recorded.
STATISTICAL ANALYSIS
Statistical analysis was done using Kruskal-Wallis test (nonparametric ANOVA).
RESULTS
The incidence of complete response (no PONV, no rescue medication) was 96% with G+D, as compared with 86% with granisetron and 4% with ondansetron during 0-3h after surgery which was clinically significant (P < 0.05). Similarly clinically significant response was seen during 3-6, 6-9, 9-12 and 12-24 h of surgery.
CONCLUSION
Granisetron and dexamethasone combination is more effective for prevention of PONV in comparison to individual ondansetron and granisetron in MRM.",2014,Granisetron and dexamethasone combination is more effective for prevention of PONV in comparison to individual ondansetron and granisetron in MRM.,"['after modified radical mastectomy', 'female patients', '75 patients (20-60 years of age) undergoing elective MRM']","['granisetron 40 mcg/kg and group granisetron and dexamethasone', 'ondansetron, granisetron and granisetron and dexamethasone combination', 'modified radical mastectomy (MRM', 'ondansetron', 'granisetron 40 mcg/kg + dexamethasone', 'Granisetron', 'dexamethasone', 'granisetron']","['Postoperative nausea and vomiting prophylaxis', 'incidence of complete response (no PONV, no rescue medication']","[{'cui': 'C0024883', 'cui_str': 'Modified Mastectomy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0024883', 'cui_str': 'Modified Mastectomy'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",75.0,0.341351,Granisetron and dexamethasone combination is more effective for prevention of PONV in comparison to individual ondansetron and granisetron in MRM.,"[{'ForeName': 'Pushplata', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Senior Consultant Anesthesia, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Shilpi', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Senior Resident Anesthesia, MBS Hospital, Nayapura, Kota, Rajasthan, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.144081']
2005,25558191,Effect of single oral dose of tramadol on gastric secretions pH.,"BACKGROUND
Tramadol is an atypical analgesic agent. It has been shown that intramuscular or intravenous injection tramadol is able to inhibit M3 muscarinic receptors. Tramadol is able to mediate smooth muscles contraction and glandular secretions. We have evaluated the effects of single oral dose of tramadol given preoperatively on gastric juices pH in patients electively scheduled for laparoscopic cholecystectomy.
MATERIALS AND METHODS
Sixty adult, American Society of Anesthesiologist I and II patients scheduled for laparoscopic cholecystectomy were included in the study. Patients were randomly assigned to receive either placebo (n = 30) or oral tramadol 50 mg (n = 30). General anesthesia was induced using propofol, fentanyl and cisatracurium. After induction of anesthesia 5 ml of gastric fluid was aspirated through orogastric tube. The gastric fluid pH was measured using pH meter.
RESULT
There was no significant difference in the pH between the groups. Gastric pH of the placebo and tramadol groups was 1.97 versus 1.98 (P = 0.092) respectively.
CONCLUSION
Preoperatively single oral dose of tramadol was unable to elevate the desired level of gastric acid secretions pH (>2.5). This may be due to pharmacokinetic disparity between the analgesic and pH elevating properties of tramadol.",2015,"Gastric pH of the placebo and tramadol groups was 1.97 versus 1.98 (P = 0.092) respectively.
","['patients electively scheduled for laparoscopic cholecystectomy', 'Sixty adult, American Society of Anesthesiologist I and II patients scheduled for']","['laparoscopic cholecystectomy', 'oral tramadol', 'placebo and tramadol', 'placebo', 'propofol, fentanyl and cisatracurium', 'tramadol', 'Tramadol']","['Gastric pH', 'gastric juices pH', 'gastric secretions pH', 'level of gastric acid secretions pH', 'gastric fluid pH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}]","[{'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C0017133', 'cui_str': 'Gastric Juice'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0232552', 'cui_str': 'Gastric acid secretion (observable entity)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]",60.0,0.135228,"Gastric pH of the placebo and tramadol groups was 1.97 versus 1.98 (P = 0.092) respectively.
","[{'ForeName': 'Khan Mueen', 'Initials': 'KM', 'LastName': 'Ullah', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Aqil', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Altaf', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Al Zahrani', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hillis', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.146252']
2006,25558190,0.5% levobupivacaine versus 0.5% ropivacaine: Are they different in ultrasound-guided sciatic block?,"CONTEXT AND AIMS
Little is known about onset and duration of sciatic block after 0.5% levobupivacaine (Levo) versus 0.5% ropivacaine (Ropi) for ultrasound-guided technique. We assessed these parameters in the ultrasound-guided block, to know for the practice.
SETTING AND DESIGN
A comparative randomized double-blind study was conducted in the University Hospital.
MATERIALS AND METHODS
Were included 35 adults of ASA I-II, scheduled for foot surgery, presenting clear imaging of their sciatic nerve at mid-thigh. A volume of 20 mL of either 0.5% Levo or 0.5% Ropi were injected around the sciatic nerve at mid-thigh using ultrasound guidance (out of the plane) followed by placement of a catheter to use, if necessary, for perioperative analgesia. A femoral single shot block was systematically performed to block the saphenous nerve. The onset times until complete foot block (primary outcome) and the sensory and motor block duration (secondary outcome) were assessed using Wilcoxon test. Values were expressed as medians (1(st)-3(rd) quartile).
RESULTS
Except for two delayed sciatic blocks in each group, the onset time otherwise was 35 min (20-60) in Ropi versus 40 min (30-60) in Levo, P = 0.5. Sensory block lasted longer in Levo, 17 h (14-27) compared with 15 h (10-17) in Ropi, P = 0.04. No significant between-group difference was found with motor block durations, 15 h (12-18) in Levo and 15 h (12-16) in Ropi, P = 0.3.
CONCLUSION
No difference of onset times was found in ultrasound-guided sciatic block whether using Levo or Ropi. Levo induced a longer-lasting sensory block.",2015,"No significant between-group difference was found with motor block durations, 15 h (12-18) in Levo and 15 h (12-16) in Ropi, P = 0.3.
","['University Hospital', 'Were included 35 adults of ASA I-II, scheduled for foot surgery, presenting clear imaging of their sciatic nerve at mid-thigh']","['ropivacaine', 'levobupivacaine', 'levobupivacaine (Levo) versus 0.5% ropivacaine (Ropi']","['onset time otherwise', 'Levo induced a longer-lasting sensory block', 'motor block durations', 'sensory and motor block duration (secondary outcome']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0188413', 'cui_str': 'Operative procedure on foot'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0036394', 'cui_str': 'Sciatic Nerve'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.172617,"No significant between-group difference was found with motor block durations, 15 h (12-18) in Levo and 15 h (12-16) in Ropi, P = 0.3.
","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pham Dang', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Hotel-Dieu, University Hospital of Nantes, 44093 France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Langlois', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Hotel-Dieu, University Hospital of Nantes, 44093 France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Hotel-Dieu, University Hospital of Nantes, 44093 France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Hopital Saint Jacques, University Hospital of Nantes, 44093 France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Hotel-Dieu, University Hospital of Nantes, 44093 France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Lejus', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Hotel-Dieu, University Hospital of Nantes, 44093 France.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.146250']
2007,28945839,Validation of a new prognostic model to easily predict outcome in renal cell carcinoma: the GRANT score applied to the ASSURE trial population.,"Background
Prognostic scores have been developed to estimate the risk of recurrence and the probability of survival after nephrectomy for renal cell carcinoma (RCC). The use of these tools, despite being helpful to plan a customized schedule of follow-up, to the patient's tailored counselling and to select individuals who could potentially benefit from adjuvant treatment, currently is not routine, due to their relative complexity and to the lack of histological data (i.e. necrosis).
Patients and methods
We developed a simple score called GRade, Age, Nodes and Tumor (GRANT) based on four easily obtained parameters: Fuhrman grade, age, pathological nodal status and pathological tumor size. Patients with 0 or 1 factor are classified as favorable risk, whereas patients with two or more risk factors as unfavorable risk. The large population of RCC patients from the ASSURE adjuvant trial was used as independent dataset for this external validation, to investigate the prognostic value of the new score in terms of disease-free survival and overall survival and to evaluate its possible application as predictive tool. Statistical analyses were carried out by the Department of Biostatistics & Computational Biology, Dana-Farber Cancer Institute (Boston, USA) for the ASSURE trial patients' population.
Results
The performance of the new model is similar to that of the already validated score systems, but its strength, compared with the others already available, is the ease and clarity of its calculation, with great speed of use during the clinical practice. Limitations are the use of the Fuhrman nuclear grade, not valid for rare histologies, and the TNM classification modifications over time.
Conclusion
The GRANT score demonstrated its potential usefulness for clinical practice.
ClinicalTrials.gov Identifier for the ASSURE trial
NCT00326898.",2017,"The performance of the new model is similar to that of the already validated score systems, but its strength, compared with the others already available, is the ease and clarity of its calculation, with great speed of use during the clinical practice.",['renal cell carcinoma'],[],[],"[{'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]",[],[],4.0,0.0534203,"The performance of the new model is similar to that of the already validated score systems, but its strength, compared with the others already available, is the ease and clarity of its calculation, with great speed of use during the clinical practice.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Buti', 'Affiliation': 'Medical Oncology Unit, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Puligandla', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bersanelli', 'Affiliation': 'Medical Oncology Unit, University Hospital of Parma, Parma, Italy. Electronic address: bersamel@libero.it.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'Medical Oncology Unit, Medical Center, University of Kentucky, Lexington, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Manola', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Taguchi', 'Affiliation': 'Department of Urology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Haas', 'Affiliation': 'Abramson Cancer Center, Philadelphia, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx492']
2008,31267962,NEJ026 trial: progression-free survival benefit is not enough.,,2019,,[],[],[],[],[],[],,0.101126,,"[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. Electronic address: liangfei0726@163.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30397-3']
2009,25422608,Combined spinal and general anesthesia is better than general anesthesia alone for laparoscopic hysterectomy.,"CONTEXT
Spinal anesthesia (SA) was combined with general anesthesia (GA) for achieving hemodynamic stability in laparoscopic hysterectomy.
AIMS
The aim of our study was to evaluate the impact of SA combined with GA in maintaining hemodynamic stability in laparoscopic hysterectomy. The secondary outcomes studied were requirement of inhaled anesthetics, vasodilators, and recovery profile.
SETTINGS AND DESIGN
We conducted a prospective, randomized study in ASAI/II patients posted for laparoscopic hysterectomy, who were willing to participate in the study.
MATERIALS AND METHODS
Patients were randomly assigned to receive SA with GA (group SGA) or plain GA (group GA). Group SGA received 10 mg bupivacaine (heavy) for SA. GA was administered using conventional balanced technique. Maintenance was carried out with nitrous oxide, oxygen, and isoflurane. Comparison of hemodynamic parameters was carried out during creation of pneumoperitoneum and thereafter. Total isoflurane requirement, need of vasodilators, recovery profile, and regression of SA were studied.
STATISTICAL ANALYSIS USED
Descriptive statistics in the form of mean, standard deviation, frequency, and percentages were calculated for interval and categorical variables, respectively. One-way analysis of variance (ANOVA) was applied for noting significant difference between the two groups, with chi-square tests for categorical variables and post-hoc Bonferroni test for interval variables. Comparison of heart rate (HR), mean arterial pressure (MAP), SPO2, and etCO2 was done with Student's t-test or Mann-Whitney test, wherever applicable.
RESULTS
Patients in group SGA maintained stable and acceptable MAP values throughout pneumoperitoneum. The difference as compared to group GA was statistically significant (P < 0.01). Group GA showed additional requirement of metoprolol (53.33%) and higher concentration of isoflurane (P < 0.001) to combat the increased MAP. Recovery was early and quick in group SGA as against group GA (P = 0.000). There were no adverse/residual effects of SA.
CONCLUSION
The hemodynamic repercussions during pneumoperitoneum can be effectively attenuated by combining SA and GA, without any adverse effects.",2014,"The hemodynamic repercussions during pneumoperitoneum can be effectively attenuated by combining SA and GA, without any adverse effects.","['Patients', 'ASAI/II patients posted for laparoscopic hysterectomy, who were willing to participate in the study', 'laparoscopic hysterectomy']","['SA combined with GA', 'GA', 'metoprolol', 'bupivacaine', 'nitrous oxide, oxygen, and isoflurane', 'general anesthesia (GA', 'Combined spinal and general anesthesia', 'SA with GA (group SGA) or plain GA']","['hemodynamic stability', 'heart rate (HR), mean arterial pressure (MAP), SPO2, and etCO2', 'acceptable MAP values', 'hemodynamic repercussions', 'Total isoflurane requirement, need of vasodilators, recovery profile, and regression of SA', 'requirement of inhaled anesthetics, vasodilators, and recovery profile', 'higher concentration of isoflurane']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator Drugs'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0470043,"The hemodynamic repercussions during pneumoperitoneum can be effectively attenuated by combining SA and GA, without any adverse effects.","[{'ForeName': 'Poonam S', 'Initials': 'PS', 'LastName': 'Ghodki', 'Affiliation': 'Department of Anaesthesiology, Shrimati Kashibai Navale Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Shalini P', 'Initials': 'SP', 'LastName': 'Sardesai', 'Affiliation': 'Department of Anaesthesiology, Shrimati Kashibai Navale Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Ramesh W', 'Initials': 'RW', 'LastName': 'Naphade', 'Affiliation': 'Department of Anaesthesiology, Shrimati Kashibai Navale Medical College, Pune, Maharashtra, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140864']
2010,25422610,A randomized trial evaluating low doses of propofol infusion after intravenous ketamine for ambulatory pediatric magnetic resonance imaging.,"OBJECTIVE
Our study compared the discharge time after pediatric magnetic resonance imaging (MRI) following sedation with propofol infusion dose of 100, 75 and 50 mcg/kg/min given after a bolus dose of ketamine and propofol.
MATERIALS AND METHODS
One hundred children of American Society of Anesthesiologists status 1/2, aged 6 months to 8 years, scheduled for elective MRI were enrolled and randomized to three groups to receive propofol infusion of 100, 75 or 50 mcg/kg/min (Groups A, B, and C, respectively). After premedicating children with midazolam 0.05 mg/kg intravenous (i.v.), sedation was induced with bolus dose of ketamine and propofol (1 mg/kg each) and the propofol infusion was connected. During the scan, heart rate, noninvasive blood pressure, respiratory rate, and oxygen saturation were monitored.
RESULTS
The primary outcome that is, discharge time was shortest for Group C (44.06 ± 18.64 min) and longest for Group A (60.00 ± 18.66 min), the difference being statistically and clinically significant. The secondary outcomes that is, additional propofol boluses, scan quality and awakening time were comparable for the three groups. The systolic blood pressure at 20, 25 and 30 min was significantly lower in Groups A and B compared with Group C. The incidence of sedation related adverse events was highest in Group A and least in Group C.
CONCLUSION
After a bolus dose of ketamine and propofol (1 mg/kg each), propofol infusion of 50 mcg/kg/min provided sedation with shortest discharge time for MRI in children premedicated with midazolam 0.05 mg/kg i.v. It also enabled stable hemodynamics with less adverse events.",2014,"The systolic blood pressure at 20, 25 and 30 min was significantly lower in Groups A and B compared with Group C.","['ambulatory pediatric magnetic resonance imaging', 'One hundred children of American Society of Anesthesiologists status 1/2, aged 6 months to 8 years, scheduled for elective MRI']","['pediatric magnetic resonance imaging (MRI', 'midazolam', 'propofol', 'ketamine', 'ketamine and propofol']","['heart rate, noninvasive blood pressure, respiratory rate, and oxygen saturation', 'systolic blood pressure', 'additional propofol boluses, scan quality and awakening time', 'discharge time', 'incidence of sedation related adverse events']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0441633'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",100.0,0.158709,"The systolic blood pressure at 20, 25 and 30 min was significantly lower in Groups A and B compared with Group C.","[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Sethi', 'Affiliation': ""Department of Anesthesia, Employees' State Insurance-Postgraduate Institute of Medical Sciences and Research, New Delhi, India.""}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': ""Department of Anesthesia, Employees' State Insurance-Postgraduate Institute of Medical Sciences and Research, New Delhi, India.""}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Subramanian', 'Affiliation': ""Department of Anesthesia, Employees' State Insurance-Postgraduate Institute of Medical Sciences and Research, New Delhi, India.""}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140871']
2011,25422612,General anesthesia plus ilioinguinal nerve block versus spinal anesthesia for ambulatory inguinal herniorrhapy.,"OBJECTIVE
The aim was to evaluate general anesthesia (GA) plus ilioinguinal nerve block (IIB) versus spinal anesthesia (SA) in patients scheduled for ambulatory inguinal hernia repair regarding pain management, anesthesia recovery and reducing potential complications.
MATERIALS AND METHODS
A double-blind, prospective, randomized, controlled study in patients American Society of Anesthesiologists I-III randomized into two groups: GA plus IIB group, induction of anesthesia with propofol, maintenance with sevoflurane, airway management with laryngeal mask allowing spontaneous ventilation and ultrasound-guided IIB; SA group, patients who underwent spinal block with 2% mepivacaine. The study variables were pain intensity, assessed by visual analog scale, analgesic requirements until hospital discharge, time to ambulation and discharge, postoperative complications-related to both techniques and satisfaction experienced.
RESULTS
Thirty-two patients were enrolled; 16 patients in each group. The differences regarding pain were statistically significant at 2 h of admission (P < 0.001) and at discharge (P < 0.001) in favor of the GA plus ilioinguinal block group. In addition in this group, analgesic requirements were lower than SA group (P < 0.001), with times of ambulation and discharge significantly shorter. The SA group had a higher tendency to develop complications and less satisfaction.
CONCLUSION
General anesthesia plus IIB is better than SA regarding postoperative analgesia, time to mobilization and discharge, side-effect profile and satisfaction experienced by the patients.",2014,The differences regarding pain were statistically significant at 2 h of admission (P < 0.001) and at discharge (P < 0.001) in favor of the GA plus ilioinguinal block group.,"['patients American Society of Anesthesiologists I-III randomized into two groups', 'Thirty-two patients were enrolled; 16 patients in each group', 'patients scheduled for ambulatory inguinal hernia repair regarding pain management', 'ambulatory inguinal herniorrhapy']","['GA plus IIB group, induction of anesthesia with propofol, maintenance with sevoflurane, airway management with laryngeal mask allowing spontaneous ventilation and ultrasound-guided IIB; SA', 'spinal block with 2% mepivacaine', 'general anesthesia (GA) plus ilioinguinal nerve block (IIB) versus spinal anesthesia (SA', 'General anesthesia plus ilioinguinal nerve block versus spinal anesthesia']","['analgesic requirements', 'pain', 'pain intensity, assessed by visual analog scale, analgesic requirements until hospital discharge, time to ambulation and discharge, postoperative complications-related to both techniques and satisfaction experienced']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0150126', 'cui_str': 'Airway Control'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0394766', 'cui_str': 'Local anesthetic block of ilioinguinal nerve (procedure)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",32.0,0.0650356,The differences regarding pain were statistically significant at 2 h of admission (P < 0.001) and at discharge (P < 0.001) in favor of the GA plus ilioinguinal block group.,"[{'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Vizcaíno-Martínez', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Complejo Hospitalario Universitario de A Coruña, A Coruña, Galicia, Spain.'}, {'ForeName': 'Manuel Ángel', 'Initials': 'MÁ', 'LastName': 'Gómez-Ríos', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Complejo Hospitalario Universitario de A Coruña, A Coruña, Galicia, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'López-Calviño', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Complejo Hospitalario Universitario de A Coruña, A Coruña, Galicia, Spain.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140883']
2012,31542304,"Androgen Receptor Modulation Optimized for Response-Splice Variant: A Phase 3, Randomized Trial of Galeterone Versus Enzalutamide in Androgen Receptor Splice Variant-7-expressing Metastatic Castration-resistant Prostate Cancer.","BACKGROUND
Detection of androgen receptor (AR) splice variant-7 (AR-V7) messenger RNA (mRNA) in circulating tumor cells (CTCs) is associated with a suboptimal response to abiraterone and enzalutamide in metastatic castration-resistant prostate cancer (mCRPC). Galeterone inhibits CYP17 and AR, and induces AR protein degradation. We hypothesized that galeterone would be clinically superior to enzalutamide in AR-V7-positive (AR-V7+) mCRPC.
OBJECTIVE
To screen and characterize AR-V7+ mCRPC, and evaluate galeterone compared with enzalutamide.
DESIGN, SETTING, AND PARTICIPANTS
This was a multicenter randomized phase 3 trial; enzalutamide-, abiraterone-, and chemotherapy-naïve mCRPC patients had AR-V7 prescreening using a CTC-based mRNA assay.
INTERVENTION
AR-V7+ patients were randomized (1:1) to open-label galeterone or enzalutamide; planned sample size was 148.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary endpoint was radiographic progression-free survival (rPFS). Baseline AR-V7 status was correlated with patient characteristics.
RESULTS AND LIMITATIONS
Overall, 953 men were prescreened for AR-V7; 323 (34%) had detectable CTCs, and 73/323 had AR-V7 mRNA. The AR-V7+ prevalence was 8% (73/953; 95% confidence interval [CI] 6-10%). AR-V7 was associated with indicators of advanced and high-volume disease at baseline, including higher prostate-specific antigen (PSA) level (p < 0.001), more bone metastases (p < 0.001), docetaxel for hormone-sensitive disease (p < 0.001), prior first-generation androgen deprivation therapy (p < 0.001), and shorter time from diagnosis to enrollment (p < 0.001). Of 73 eligible patients, 38 were randomized to galeterone (n=19) or enzalutamide (n=19); 35 dropped out before randomization. Owing to high censorship for the rPFS events, the data monitoring committee recommended early closure based on interim evidence that the primary endpoint would not be met. The PSA50 values were 2/16 (13%) and 8/19 (42%) for galeterone and enzalutamide respectively (proportion difference=-0.278, 95% CI -0.490 to 0.097).
CONCLUSIONS
The prevalence of CTC mRNA AR-V7 in first-line mCRPC was 8% (95% CI 6-10%). AR-V7+ was associated with the characteristics of aggressive and advanced disease. These men had rapid disease progression. Development of galeterone will not be pursued.
PATIENT SUMMARY
Of men with metastatic castration-resistant prostate cancer, 8% had the androgen receptor splice variant-7 (AR-V7) blood biomarker. The AR-V7+ patients had features of aggressive disease. Thirty-eight men were treated with either galeterone or enzalutamide; the trial was stopped early prior to determining efficacy because too many patients transitioned off the trial due to advancing cancer before having required radiographs.",2019,"AR-V7 was associated with indicators of advanced and high-volume disease at baseline, including higher prostate-specific antigen (PSA) level (p < 0.001), more bone metastases (p < 0.001), docetaxel for hormone-sensitive disease (p < 0.001), prior first-generation androgen deprivation therapy (p < 0.001), and shorter time from diagnosis to enrollment (p < 0.001).","['73 eligible patients, 38 were randomized to', 'Thirty-eight men', 'men with metastatic castration-resistant prostate cancer, 8% had the androgen receptor splice variant-7 (AR-V7) blood biomarker', 'Androgen Receptor Splice', 'naïve mCRPC patients had AR-V7 prescreening using a CTC-based mRNA assay', 'metastatic castration-resistant prostate cancer (mCRPC', 'Response-Splice Variant', '953 men were prescreened for AR-V7; 323 (34%) had detectable CTCs, and 73/323 had AR-V7 mRNA', 'Variant-7-expressing Metastatic Castration-resistant Prostate Cancer']","['docetaxel', 'galeterone or enzalutamide', 'enzalutamide', 'abiraterone and enzalutamide', 'open-label galeterone or enzalutamide', 'enzalutamide-, abiraterone-, and chemotherapy', 'Galeterone Versus Enzalutamide', 'galeterone']","['bone metastases', 'PSA50 values', 'prevalence of CTC mRNA AR-V7', 'higher prostate-specific antigen (PSA) level', 'radiographic progression-free survival (rPFS', 'Baseline AR-V7 status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1569219', 'cui_str': '3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",953.0,0.1197,"AR-V7 was associated with indicators of advanced and high-volume disease at baseline, including higher prostate-specific antigen (PSA) level (p < 0.001), more bone metastases (p < 0.001), docetaxel for hormone-sensitive disease (p < 0.001), prior first-generation androgen deprivation therapy (p < 0.001), and shorter time from diagnosis to enrollment (p < 0.001).","[{'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: Mary_taplin@dfci.harvard.edu.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Medical Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Ferrante', 'Affiliation': 'Oncology Strategic Advisor and Board Member (formerly Tokai Pharmaceuticals), East Greenwich, RI, USA.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Horgan', 'Affiliation': 'Vertex Pharmaceuticals (formerly Tokai Pharmaceuticals), Boston, MA, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Blumenstein', 'Affiliation': 'Trial Architecture Consulting, Chevy Chase, MD, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'Urology, University of Montreal Hospital Center, Montreal, Canada.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Urology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'Medical Oncology, Royal Marsden/The Institute of Cancer Research, London, UK.'}]",European urology,['10.1016/j.eururo.2019.08.034']
2013,25538520,"Identification of epidural space using loss of resistance syringe, infusion drip, and balloon technique: A comparative study.","BACKGROUND AND OBJECTIVE
There are various techniques to identify epidural space but superiority of one technique over other has not been adequately studied. We conducted a study to Compare and evaluate the three techniques for epidural space localization that is, loss of resistance (LOR) syringe technique, balloon technique and drip infusion technique.
MATERIALS AND METHODS
Seventy-five patients of either sex, belonging to American Society of Anesthesiologists physical status Class 1 or 2, between 20 and 50 years of age, scheduled to undergo lower abdominal and lower limb surgeries were randomly allocated to one of the three groups (n = 25 each) depending upon epidural space localization. In Group I, epidural space localization was done with LOR syringe technique. In Group II Balloon technique and in Group III drip infusion technique was used. Distance of the epidural space from skin, number of attempts, time taken for epidural space localization and quality of the block were the parameter recorded during the study.
RESULTS
First attempt success rate for epidural space localization was highest in Group III (100%). The mean time taken for epidural space localization was least in Group III, and when compared with other groups it was found to be statistically significant with P = 0.016. Number of attempt for space localization and success rate of the block was better in the majority of patients of Group III, but the difference was found to be statistically nonsignificant. Complication rate was almost negligible in all three techniques.
CONCLUSION
We conclude that the time taken to localize the epidural space was least in drip infusion technique. As for number of attempts, quality of the block and complications is concerned, all the three techniques are comparable.",2014,"Number of attempt for space localization and success rate of the block was better in the majority of patients of Group III, but the difference was found to be statistically nonsignificant.","['Seventy-five patients of either sex, belonging to American Society of Anesthesiologists physical status Class 1 or 2, between 20 and 50 years of age, scheduled to undergo lower abdominal and lower limb surgeries']","['LOR syringe technique', 'resistance syringe, infusion drip, and balloon technique']","['epidural space localization', 'Complication rate', 'mean time taken for epidural space localization']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1531504', 'cui_str': 'ASA physical status class 1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0452837', 'cui_str': 'Dripping (substance)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]","[{'cui': 'C0228134', 'cui_str': 'Epidural Space'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",,0.0204324,"Number of attempt for space localization and success rate of the block was better in the majority of patients of Group III, but the difference was found to be statistically nonsignificant.","[{'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Singhal', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pt. B. D. Sharma, PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Bala', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pt. B. D. Sharma, PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Kiranpreet', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pt. B. D. Sharma, PGIMS, Rohtak, Haryana, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.144070']
2014,25538522,Comparison of serum triglyceride levels with propofol in long chain triglyceride and propofol in medium and long chain triglyceride after short term anesthesia in pediatric patients.,"BACKGROUND
Significant increase in serum triglyceride (ST) concentration have been described in adult population after prolonged administration of propofol formulation containing long chain triglyceride (LCT). Though, medium chain triglyceride-LCT (MCT-LCT) propofol when compared with LCT propofol for long-term sedation in adults resulted in identical triglyceride levels, the elimination of triglyceride was faster in patients administered MCT-LCT propofol.
MATERIALS AND METHODS
A total of 40 children were randomized into two groups of 20 each; Group I were induced with 1% LCT propofol (3 mg/kg) and Group II with 1% medium and LCT propofol and maintained with descalating dose of 20.15 and 10 mg/kg/h at 10 min intervals. Blood samples for ST concentration were obtained before induction of anesthesia, at the end of propofol infusion and 4 h after terminating propofol infusion.
RESULTS
ST levels were raised significantly above the basal values in both the groups but the rise was significantly higher in Group I (P < 0.05). Four hours after stopping propofol infusion the triglyceride levels were similar to the basal values in Group II, whereas in Group I the values were significantly greater than the baseline (P < 0.05) as well as those of Group II (P < 0.05). No clinically significant adverse effect of hypertriglyceridemia was observed.
CONCLUSION
Even short term anesthesia with LCT and MCT-LCT propofol (1%) leads to elevated ST levels. The increase in ST levels is less with MCT-LCT propofol and elimination of triglyceride is also rapid after terminating MCT-LCT propofol infusion.",2014,"RESULTS
ST levels were raised significantly above the basal values in both the groups but the rise was significantly higher in Group I (P < 0.05).","['pediatric patients', '40 children']","['LCT propofol', 'MCT-LCT propofol', 'LCT propofol (3 mg/kg) and Group II with 1% medium and LCT propofol', 'propofol', 'medium chain triglyceride-LCT (MCT-LCT) propofol', 'propofol formulation containing long chain triglyceride (LCT', 'LCT and MCT-LCT propofol']","['Blood samples for ST concentration', 'serum triglyceride (ST) concentration', 'identical triglyceride levels, the elimination of triglyceride', 'triglyceride levels', 'ST levels', 'serum triglyceride levels', 'adverse effect of hypertriglyceridemia', 'elevated ST levels']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3873606', 'cui_str': 'Long chain triglyceride (substance)'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}]",40.0,0.0155753,"RESULTS
ST levels were raised significantly above the basal values in both the groups but the rise was significantly higher in Group I (P < 0.05).","[{'ForeName': 'Ishwar', 'Initials': 'I', 'LastName': 'Bhukal', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Gokul', 'Initials': 'G', 'LastName': 'Thimmarayan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Bala', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sohan Lal', 'Initials': 'SL', 'LastName': 'Solanki', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Samra', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.144076']
2015,25538523,"Effect of clonidine versus dexmedetomidine on pain control after laparoscopic gastric sleeve: A prospective, randomized, double-blinded study.","BACKGROUND
The use of opioids in surgeries for morbidly obese patients could cause respiratory depression. Therefore, alternative analgesics are needed to improve anesthetic management for obese patients. The objective of this study was to compare the effect of dexmedetomidine and clonidine on pain as well as analgesic consumption at 24 h postoperatively in patients undergoing laparoscopic gastric sleeve. The secondary objective was to compare patients' and surgeons' satisfaction.
MATERIALS AND METHODS
A total of 60 obese and morbidly obese patients scheduled to undergo laparoscopic gastric sleeve were randomly assigned into two groups. 10 min after induction of general anesthesia, one group received 0.8-1.2 μg/kg/30 min intravenous (IV) clonidine through 500 mL lactated Ringer's solution and placebo (normal saline solution) through syringe pump. The second group received IV dexmedetomidine through syringe pump at a rate 0.5-0.8 μg/kg/h and placebo through 500 mL lactated Ringer's solution. Data on pain, analgesic consumption, and return to normal activity in addition to patients' and surgeons' satisfaction were collected.
RESULTS
Both groups were similar with respect to demographic and intraoperative hemodynamic characteristics. Fentanyl consumption, surgery duration and hospital stay were similar for the two groups. Pain scores on walking were significantly lower in the clonidine group at 12 h postoperatively (P = 0.014) compared with dexmedetomidine group. The number of patients who consumed pethidine was significantly lower in the clonidine group at 12 h postoperatively (P = 0.045).
CONCLUSION
This study concluded that clonidine and dexmedetomidine yielded similar outcomes with a difference in pain and analgesic consumption at 12 h postoperatively.",2014,Pain scores on walking were significantly lower in the clonidine group at 12 h postoperatively (P = 0.014) compared with dexmedetomidine group.,"['patients undergoing laparoscopic gastric sleeve', '60 obese and morbidly obese patients scheduled to undergo laparoscopic gastric sleeve', 'morbidly obese patients', 'obese patients', 'pain control after laparoscopic gastric sleeve']","['opioids', 'dexmedetomidine and clonidine', ""placebo through 500 mL lactated Ringer's solution"", 'pethidine', 'dexmedetomidine through syringe pump', 'clonidine', ""clonidine through 500 mL lactated Ringer's solution and placebo (normal saline solution) through syringe pump"", 'dexmedetomidine']","['pain as well as analgesic consumption', 'Fentanyl consumption, surgery duration and hospital stay', 'pain, analgesic consumption, and return to normal activity', 'pain and analgesic consumption', 'Pain scores on walking']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0181332', 'cui_str': 'Syringe pump (physical object)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",60.0,0.516883,Pain scores on walking were significantly lower in the clonidine group at 12 h postoperatively (P = 0.014) compared with dexmedetomidine group.,"[{'ForeName': 'Zoher M', 'Initials': 'ZM', 'LastName': 'Naja', 'Affiliation': 'Department of Anesthesia and Pain Management, Makassed General Hospital, Beirut, Lebanon.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Khatib', 'Affiliation': 'Department of Anesthesia and Pain Management, Makassed General Hospital, Beirut, Lebanon.'}, {'ForeName': 'Fouad M', 'Initials': 'FM', 'LastName': 'Ziade', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Moussa', 'Affiliation': 'Department of Anesthesia and Pain Management, Makassed General Hospital, Beirut, Lebanon.'}, {'ForeName': 'Zeina Z', 'Initials': 'ZZ', 'LastName': 'Naja', 'Affiliation': 'Department of Pediatric, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ahmad Salah Eddine', 'Initials': 'AS', 'LastName': 'Naja', 'Affiliation': 'Resident at the Faculty of Medicine, Lebanese American University, Beirut, Lebanon.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Kanawati', 'Affiliation': 'Department of Anesthesia and Pain Management, Makassed General Hospital, Beirut, Lebanon.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.144078']
2016,25538525,Randomized controlled trial to evaluate intraocular pressure following sub-Tenon's local anesthesia for cataract surgery: With and without hyaluronidase added to anesthetic solution.,"AIM
To evaluate effect on intraocular pressure (IOP) during sub-Tenon's local anesthesia (LA) during cataract surgery with 4 ml of anesthetic injected without and with addition of hyluronidase to anesthetic solution.
MATERIALS AND METHODS
This randomized controlled study included 65 eyes of 65 patients undergoing phacoemulsification and lens implant for cataract. The patients were randomized to a standardized procedure of administration of 4 ml of sub-Tenon's LA without and with addition of 15 IU/ml hylaluronidase to 2% lidocaine (control group and intervention group respectively). IOP measurements were carried out immediately prior to and at 2, 5, and 10 and 15 min after sub-Tenon's injection using a hand held tonometer (Tonopen).
RESULTS
All patients achieved satisfactory akinesia and complete analgesia during surgery. The mean age of patients in control group was 59.56 ± 14.3 years, and 61.77 ± 11.91 years in intervention group (P = 0.507). The mean preinjection and 15 min IOP was 19.16 ± 4.39 and 20.21 ± 5.49 mm Hg, respectively in control group (P = 0.220); and 19.81 ± 3.8 and 19.68 ± 5.19 mmHg respectively in intervention group (P = 0.911). No statistical difference from baseline was detected between preinjection and at 2, 5, 10, and 15 min after injection in control (P = 0.124, 0.310, 0.804, 0.220, respectively) and intervention group (P = 0.367, 0.879, 0.765, 0.911 respectively).
CONCLUSION
No significant rise in IOP occurs following injection of sub-Tenon's LA, when up to 4 ml of anesthetic is injected. The addition of hyaluronidase to 2% lignocaine has no beneficial lowering effect on IOP in sub-Tenon's LA. Hence, the practice of addition of this agent may not be necessary during cataract surgery.",2014,The addition of hyaluronidase to 2% lignocaine has no beneficial lowering effect on IOP in sub-Tenon's LA.,"['65 eyes of 65 patients undergoing', 'cataract surgery']","['lignocaine', ""sub-Tenon's local anesthesia (LA"", ""standardized procedure of administration of 4 ml of sub-Tenon's LA without and with addition of 15 IU/ml hylaluronidase to 2% lidocaine"", 'phacoemulsification and lens implant for cataract', ""intraocular pressure following sub-Tenon's local anesthesia"", 'anesthetic solution']","['IOP', 'mean preinjection and 15 min IOP', 'IOP measurements', 'intraocular pressure (IOP', 'satisfactory akinesia and complete analgesia']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0023311', 'cui_str': 'Lens Implantation, Intraocular'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0085623', 'cui_str': 'Akinesia (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",65.0,0.222643,The addition of hyaluronidase to 2% lignocaine has no beneficial lowering effect on IOP in sub-Tenon's LA.,"[{'ForeName': 'Naif', 'Initials': 'N', 'LastName': 'Al-Ali', 'Affiliation': 'Cornea Division, Dhahran Eye Specialist Hospital, Dhahran, KSA.'}, {'ForeName': 'Rizwan A', 'Initials': 'RA', 'LastName': 'Cheema', 'Affiliation': 'Retina Division, Dhahran Eye Specialist Hospital, Dhahran, KSA.'}, {'ForeName': 'Medhat A', 'Initials': 'MA', 'LastName': 'Abdelaziz', 'Affiliation': 'Glaucoma Division, Dhahran Eye Specialist Hospital, Dhahran, KSA.'}, {'ForeName': 'Ashbala', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Cornea Division, Dhahran Eye Specialist Hospital, Dhahran, KSA.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.144080']
2017,25516371,A translational investigation targeting stress-reactivity and prefrontal cognitive control with guanfacine for smoking cessation.,"Stress and prefrontal cognitive dysfunction have key roles in driving smoking; however, there are no therapeutics for smoking cessation that attenuate the effects of stress on smoking and enhance cognition. Central noradrenergic pathways are involved in stress-induced reinstatement to nicotine and in the prefrontal executive control of adaptive behaviors. We used a novel translational approach employing a validated laboratory analogue of stress-precipitated smoking, functional magnetic resonance imaging (fMRI), and a proof-of-concept treatment period to evaluate whether the noradrenergic α2a agonist guanfacine (3 mg/day) versus placebo (0 mg/day) reduced stress-precipitated smoking in the laboratory, altered cortico-striatal activation during the Stroop cognitive-control task, and reduced smoking following a quit attempt. In nicotine-deprived smokers (n=33), stress versus a neutral condition significantly decreased the latency to smoke, and increased tobacco craving, ad-libitum smoking, and systolic blood pressure in placebo-treated subjects, and these effects were absent or reduced in guanfacine-treated subjects. Following stress, placebo-treated subjects demonstrated decreased cortisol levels whereas guanfacine-treated subjects demonstrated increased levels. Guanfacine, compared with placebo, altered prefrontal activity during a cognitive-control task, and reduced cigarette use but did not increase complete abstinence during treatment. These preliminary laboratory, neuroimaging, and clinical outcome data were consistent and complementary and support further development of guanfacine for smoking cessation.",2015,"Guanfacine, compared with placebo, altered prefrontal activity during a cognitive-control task, and reduced cigarette use but did not increase complete abstinence during treatment.",[],"['guanfacine', 'noradrenergic α2a agonist guanfacine', 'placebo', 'Guanfacine']","['cortisol levels', 'complete abstinence', 'prefrontal activity', 'latency to smoke, and increased tobacco craving, ad-libitum smoking, and systolic blood pressure']",[],"[{'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.0260371,"Guanfacine, compared with placebo, altered prefrontal activity during a cognitive-control task, and reduced cigarette use but did not increase complete abstinence during treatment.","[{'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'McKee', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA Cancer Prevention and Control Research Program, Yale Cancer Center, New Haven, CT, USA sherry.mckee@yale.edu.'}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Potenza', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA Department of Neurobiology, Yale University School of Medicine, New Haven, CT, USA Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kober', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Amy F T', 'Initials': 'AF', 'LastName': 'Arnsten', 'Affiliation': 'Department of Neurobiology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Marina R', 'Initials': 'MR', 'LastName': 'Picciotto', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Andrea H', 'Initials': 'AH', 'LastName': 'Weinberger', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881114562091']
2018,32424986,Efficacy of a collagen hydrolysate and antioxidants-containing nutraceutical on metrics of skin health in Indian women.,"BACKGROUND
The skin's aging process involves a decreased biosynthesis of extracellular matrix proteins (predominantly collagen) compounded by damage from environmental and intrinsic stressors. The Indian population is susceptible to skin damage given its geography and increasing urbanization or a genetic disposition. Previous studies have investigated nutrients such as collagen peptides, vitamins and phytonutrient-rich botanical extracts for their individual benefits on skin.
AIMS
This study examined the collective effect of a proprietary blend of these nutrients (in Nutrova Collagen+Antioxidants; NCA) on skin parameters, which has not been previously studied, especially in an Indian context.
PATIENTS/METHODS
34 healthy, Indian women (mean age = 39.5 years) were given a placebo daily for 30 days to establish a baseline, followed by NCA for two intervals of 30 days. 3D image reconstruction allowed the analysis of skin topography and blemishes. Instrumental measurements also included skin firmness, elasticity, hydration, and transepidermal water loss. Clinical evaluation was used to grade blemishes, wrinkles and periorbital hyperpigmentation.
RESULTS
Based on instrumental evaluation, NCA significantly reduced wrinkle width, open pores, skin roughness, and the colour of hyperpigmented blemishes, while improving skin hydration, firmness and barrier function from baseline to Day 30 and Day 60. NCA also increased elasticity at Day 30. Clinical evaluation showed that periorbital hyperpigmentation and wrinkles reduced significantly.
CONCLUSION
NCA is effective for improving overall skin health in Indian women. These results show that targeted nutrient supplementation can improve skin health and further research over extended durations is merited.",2020,"Based on instrumental evaluation, NCA significantly reduced wrinkle width, open pores, skin roughness, and the colour of hyperpigmented blemishes, while improving skin hydration, firmness and barrier function from baseline to Day 30 and Day 60.","['34 healthy, Indian women (mean age = 39.5 years', 'Indian women']","['NCA', 'collagen hydrolysate and antioxidants-containing nutraceutical', 'proprietary blend of these nutrients (in Nutrova Collagen+Antioxidants; NCA', 'placebo']","['periorbital hyperpigmentation and wrinkles reduced significantly', 'skin health', 'overall skin health', 'skin firmness, elasticity, hydration, and transepidermal water loss', 'wrinkle width, open pores, skin roughness, and the colour of hyperpigmented blemishes, while improving skin hydration, firmness and barrier function']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",34.0,0.0230159,"Based on instrumental evaluation, NCA significantly reduced wrinkle width, open pores, skin roughness, and the colour of hyperpigmented blemishes, while improving skin hydration, firmness and barrier function from baseline to Day 30 and Day 60.","[{'ForeName': 'Meghna S', 'Initials': 'MS', 'LastName': 'Motwani', 'Affiliation': 'Axys Nutrition Products Pvt. Ltd., Mumbai, India.'}, {'ForeName': 'Kaynat', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': 'Axys Nutrition Products Pvt. Ltd., Mumbai, India.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Pai', 'Affiliation': 'Axys Nutrition Products Pvt. Ltd., Mumbai, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Joshi', 'Affiliation': 'CLAIMS Pvt. Ltd., Mumbai, India.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13404']
2019,25422602,Comparative evaluation of ropivacaine versus dexmedetomidine and ropivacaine in epidural anesthesia in lower limb orthopedic surgeries.,"BACKGROUND
Various adjuvant are being used with local anesthetics for prolongation of intra operative and postoperative analgesia in epidural block for lower limb surgeries. Dexmedetomidine, the highly selective α2 adrenergic agonist is a new neuroaxial adjuvant gaining popularity. The aim of the present study was to compare the hemodynamic, sedative and analgesia potentiating effects of epidurally administered dexmedetomidine when combined with ropivacaine.
MATERIALS AND METHODS
The study was conducted in prospective, randomized double-blind manner in which 100 patients of American Society of Anesthesiologist Grade I and II in the age group of 20-65 years of either sex under going lower limb surgeries were included after taking informed consent. The patients were randomly allocated into two groups of 50 each. Epidural anesthesia was given with 150 mg of 0.75% ropivacaine in Group A (n = 50) and 150 mg of 0.75% ropivacaine with dexmedetomidine (1 μg/kg) in Group B (n = 50). Two groups were compared with respect to hemodynamic changes, block characteristics which included time to onset of analgesia at T10, maximum sensory analgesic level, time to maximum sensory and motor block, time to regression at S1 dermatome and time to the first dose of rescue analgesia for 24 h. At the end of study, data was compiled and analyzed statistically using Chi-square test, Fisher's exact test and Student t-test. P < 0.05 was considered to be significant and P < 0.001 as highly significant.
RESULTS
Significant difference was observed in relation to the duration of sensory block (375.20 ± 15.97 min in Group A and 535.18 ± 19.85 min in Group B [P - 0.000]), duration of motor block (259.80 ± 15.48 min in Group A and 385.92 ± 17.71 min in Group B [P - 0.000]), duration of post-operative analgesia (312.64 ± 16.21 min in Group A and 496.56 ± 16.08 min in Group B [P < 0.001]) and consequently low doses of rescue analgesia in Group B (1.44 ± 0.501) as compared to Group A (2.56 ± 0.67). Sedation score was significantly more in Group B in the post-operative period.
CONCLUSION
Epidural Dexmedetomidine as an adjuvant to Ropivacaine is associated with prolonged sensory and motor block, hemodynamic stability, prolonged postoperative analgesia and reduced demand for rescue analgesics when compared to plain Ropivacaine.",2014,"CONCLUSION
Epidural Dexmedetomidine as an adjuvant to Ropivacaine is associated with prolonged sensory and motor block, hemodynamic stability, prolonged postoperative analgesia and reduced demand for rescue analgesics when compared to plain Ropivacaine.","['100 patients of American Society of Anesthesiologist Grade I and II in the age group of 20-65 years of either sex under going lower limb surgeries were included after taking informed consent', 'epidural anesthesia in lower limb orthopedic surgeries']","['Epidural anesthesia', 'ropivacaine with dexmedetomidine', 'Dexmedetomidine', 'Epidural Dexmedetomidine', 'plain Ropivacaine', 'dexmedetomidine and ropivacaine', 'ropivacaine', 'Ropivacaine', 'dexmedetomidine']","['hemodynamic, sedative and analgesia potentiating effects', 'hemodynamic changes, block characteristics which included time to onset of analgesia at T10, maximum sensory analgesic level, time to maximum sensory and motor block, time to regression at S1 dermatome and time to the first dose of rescue analgesia', 'duration of motor block', 'prolonged sensory and motor block, hemodynamic stability, prolonged postoperative analgesia', 'duration of sensory block', 'Sedation score', 'duration of post-operative analgesia']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}]","[{'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0392338', 'cui_str': 'Dermatome (body structure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",,0.163989,"CONCLUSION
Epidural Dexmedetomidine as an adjuvant to Ropivacaine is associated with prolonged sensory and motor block, hemodynamic stability, prolonged postoperative analgesia and reduced demand for rescue analgesics when compared to plain Ropivacaine.","[{'ForeName': 'Sarabjit', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Anesthesia, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Joginder Pal', 'Initials': 'JP', 'LastName': 'Attri', 'Affiliation': 'Department of Anesthesia, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Department of Anesthesia, Government Medical College, Amritsar, Punjab, India.'}, {'ForeName': 'Tejinder Pal', 'Initials': 'TP', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesia, Government Medical College, Amritsar, Punjab, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140838']
2020,25422603,Comparison of the air-Q intubating laryngeal airway and the cobra perilaryngeal airway as conduits for fiber optic-guided intubation in pediatric patients.,"BACKGROUND
One of the methods proposed in cases of difficult airway management in children is using a supraglottic airway device as a conduit for tracheal intubation. The aim of this study was to compare the efficacy of the Air-Q Intubating Laryngeal Airway (Air-Q) and the Cobra Perilaryngeal Airway (CobraPLA) to function as a conduit for fiber optic-guided tracheal intubation in pediatric patients.
MATERIALS AND METHODS
A total of 60 children with ages ranging from 1 to 6 years, undergoing elective surgery, were randomized to have their airway managed with either an Air-Q or CobraPLA. Outcomes recorded were the success rate, time and number of attempts required for fiber optic-guided intubation and the time required for device removal after intubation. We also recorded airway leak pressure (ALP), fiber optic grade of glottic view and occurrence of complications.
RESULTS
Both devices were successfully inserted in all patients. The intubation success rate was comparable with the Air-Q and the CobraPLA (96.7% vs. 90%), as was the first attempt success rate (90% vs. 80%). The intubation time was significantly longer with the CobraPLA (29.5 ± 10.9 s vs. 23.2 ± 9.8 s; P < 0.05), but the device removal time was comparable in the two groups. The CobraPLA showed a significantly higher ALP (20.8 ± 5.2 cmH2O vs. 16.3 ± 4.5 cmH2O; P < 0.001), but the fiber optic grade of glottic view was comparable with the two devices. The CobraPLA was associated with a significantly higher incidence of blood staining of the device on removal and post-operative sore throat.
CONCLUSION
Both the Air-Q and CobraPLA can be used effectively as a conduit for fiber optic-guided tracheal intubation in children. However, the Air-Q proved to be superior due to a shorter intubation time and less airway morbidity compared with the CobraPLA.",2014,"The CobraPLA was associated with a significantly higher incidence of blood staining of the device on removal and post-operative sore throat.
","['pediatric patients', '60 children with ages ranging from 1 to 6 years, undergoing elective surgery']","['Air-Q Intubating Laryngeal Airway (Air-Q) and the Cobra Perilaryngeal Airway (CobraPLA', 'airway managed with either an Air-Q or CobraPLA']","['fiber optic grade of glottic view', 'intubation success rate', 'airway leak pressure (ALP), fiber optic grade of glottic view and occurrence of complications', 'success rate', 'device removal time', 'success rate, time and number of attempts required for fiber optic-guided intubation and the time required for device removal after intubation', 'airway morbidity', 'intubation time']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C3873831', 'cui_str': 'Laryngeal airway'}, {'cui': 'C0206326', 'cui_str': 'Cobra'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]","[{'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0752250', 'cui_str': 'Device Removal'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1301933', 'cui_str': 'Airway morbidity'}]",60.0,0.0542424,"The CobraPLA was associated with a significantly higher incidence of blood staining of the device on removal and post-operative sore throat.
","[{'ForeName': 'Karim K', 'Initials': 'KK', 'LastName': 'Girgis', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Maha M I', 'Initials': 'MM', 'LastName': 'Youssef', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Nashwa S', 'Initials': 'NS', 'LastName': 'ElZayyat', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Giza, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140841']
2021,25422605,Safety and reliability of the sealing cuff pressure of the Microcuff pediatric tracheal tube for prevention of post-extubation morbidity in children: A comparative study.,"OBJECTIVES
The objective of this study is to evaluate the efficacy and safety of sealing pressure as an inflation technique of the Microcuff pediatric tracheal cuffed tube.
MATERIALS AND METHODS
A total of 60 children were enrolled in this study. After induction of anesthesia and intubation with Microcuff pediatric tracheal tube, patients were randomly assigned, to one of the three groups. Control group (n = 20) the cuff was inflated to a cuff pressure of 20 cm H2O; sealing group (n = 20) the cuff was inflated to prevent the air leak at peak airway pressure of 20 cm H2O and the finger group (n = 20) the cuff was inflated to a suitable pressure using the finger estimation. Tracheal leak, incidence and severity of post-extubation cough, stridor, sore throat and hoarseness were recorded.
RESULTS
The cuff pressure as well as the volume of air to fill the cuff was significantly low in the sealing group when compared with the control group (P < 0.001); however, their values were significantly high in the finger group compared with both the control and the sealing group (P < 0.001). The incidence and severity of sore throat were significantly high in the finger group compared with both the control and the sealing group (P = 0.0009 and P = 0.0026). Three patients in the control group developed air leak around the endotracheal tube cuff. The incidence and severity of other complications were similar in the three groups.
CONCLUSION
In pediatric N2O, free general anesthesia using Microcuff pediatric tracheal tub, sealing cuff pressure is safer than finger palpation technique regarding post-extubation morbidities and more reliable than recommended safe pressure in prevention of the air leak.",2014,The incidence and severity of sore throat were significantly high in the finger group compared with both the control and the sealing group (P = 0.0009 and P = 0.0026).,"['60 children', 'children']","['Microcuff pediatric tracheal tube', 'sealing pressure']","['volume of air to fill the cuff', 'incidence and severity of other complications', 'Tracheal leak, incidence and severity of post-extubation cough, stridor, sore throat and hoarseness', 'cuff pressure', 'incidence and severity of sore throat', 'air leak']","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube (physical object)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0038450', 'cui_str': 'Stridor'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",60.0,0.0194757,The incidence and severity of sore throat were significantly high in the finger group compared with both the control and the sealing group (P = 0.0009 and P = 0.0026).,"[{'ForeName': 'Roshdi Roshdi', 'Initials': 'RR', 'LastName': 'Al-Metwalli', 'Affiliation': 'Department of Anaethesia, University of Dammam, King Fahad Hospital, Al-Khobar 31952, Saudi Arabia.'}, {'ForeName': 'Sayed', 'Initials': 'S', 'LastName': 'Sadek', 'Affiliation': 'Department of Anesthesiology, El-Fayoum University, El-Fayoum, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140856']
2022,25422606,The use of laryngeal mask airway during transesophageal echocardiography in pediatric patients.,"BACKGROUND
Transesophageal echocardiography (TEE) in the cardiac lab is usually performed in pediatric patients under general anesthesia with an endotracheal intubation (ET). This study was performed to investigate the safety and efficacy of using the laryngeal mask airway (LMA) as an alternative to ET to maintain pediatric airway during the general anesthesia for TEE.
MATERIALS AND METHODS
A total of 50 pediatric patients undergoing TEE in the cardiac lab were randomized to have their airway maintained during the procedure with either LMA (LMA group) or ET (ET group). Hemodynamic, respiratory parameters, time to extubation, recovery time, the incidence of complication and operator satisfaction were compared between the two groups.
RESULTS
There were no differences between both groups in hemodynamic and respiratory parameters. Laryngeal spasm was reported in one patient in the LMA group and two patients in the ET group. TEE operators were equally satisfied with the procedure in groups. The time to extubation was shorter in the LMA group (P < 0.01). The mean recovery time was also significantly shorter in the LMA than in the ET group (44 ± 8 min and 59 ± 11 min, respectively; P < 0.001).
CONCLUSION
The LMA is safe and effective in securing the airway of children undergoing diagnostic TEE.",2014,The time to extubation was shorter in the LMA group (P < 0.01).,"['pediatric patients', '50 pediatric patients undergoing TEE in the cardiac lab', 'pediatric patients under general anesthesia with an endotracheal intubation (ET']","['LMA (LMA group) or ET', 'Transesophageal echocardiography (TEE', 'laryngeal mask airway during transesophageal echocardiography', 'laryngeal mask airway (LMA', 'LMA']","['mean recovery time', 'Hemodynamic, respiratory parameters, time to extubation, recovery time, the incidence of complication and operator satisfaction', 'safety and efficacy', 'Laryngeal spasm', 'time to extubation']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0206054', 'cui_str': 'Echocardiography, Transesophageal'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}]",50.0,0.0208724,The time to extubation was shorter in the LMA group (P < 0.01).,"[{'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Shafi Ahmed', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, University of Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Abdulmohsin A', 'Initials': 'AA', 'LastName': 'Al-Ghamdi', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, University of Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Hany A', 'Initials': 'HA', 'LastName': 'Mowafi', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, University of Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Roshdy R', 'Initials': 'RR', 'LastName': 'Al-Metwalli', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, University of Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Wesam F', 'Initials': 'WF', 'LastName': 'Mousa', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, University of Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Amer A', 'Initials': 'AA', 'LastName': 'Lardhi', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Dammam, Dammam, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140858']
2023,25392635,Clonidine versus nitroglycerin infusion in laparoscopic cholecystectomy.,"BACKGROUND AND OBJECTIVES
Laparoscopic surgery offers the advantages of minimally invasive surgery; however, pneumoperitoneum and the patient's position induce pathophysiological changes that may complicate anesthetic management. We studied the effect of clonidine and nitroglycerin on heart rate and blood pressure, if any, in association with these drugs or the procedure, as well as the effect of these drugs, if any, on end-tidal carbon dioxide pressure and intraocular pressure.
METHODS
Sixty patients (minimum age of 20 years and maximum age of 65 years, American Society of Anesthesiologists class I or II) undergoing laparoscopic cholecystectomy were randomized into 3 groups and given an infusion of clonidine (group I), nitroglycerin (group II), or normal saline solution (group III) after induction and before creation of pneumoperitoneum. We observed and recorded the following parameters: heart rate, mean arterial blood pressure, end-tidal carbon dioxide pressure, and intraocular pressure. The mean and standard deviation of the parameters studied during the observation period were calculated for the 3 treatment groups and compared by use of analysis of variance tests. Intragroup comparison was performed with the paired t test. The critical value of P, indicating the probability of a significant difference, was taken as < .05 for comparisons.
RESULTS
Statistically significant differences in heart rate were observed among the various groups, whereas comparisons of mean arterial pressure, intraocular pressure, and end-tidal carbon dioxide pressure showed statistically significant differences only between groups I and III and between groups II and III.
CONCLUSION
We found clonidine to be more effective than nitroglycerin at preventing changes in hemodynamic parameters and intraocular pressure induced by carbon dioxide insufflation during laparoscopic cholecystectomy. It was also found not to cause hypotension severe enough to stop the infusion and warrant treatment.",2014,We found clonidine to be more effective than nitroglycerin at preventing changes in hemodynamic parameters and intraocular pressure induced by carbon dioxide insufflation during laparoscopic cholecystectomy.,"['laparoscopic cholecystectomy', 'Sixty patients (minimum age of 20 years and maximum age of 65 years, American Society of Anesthesiologists class I or II) undergoing']","['laparoscopic cholecystectomy', 'Laparoscopic surgery', 'normal saline solution', 'clonidine', 'carbon dioxide insufflation', 'Clonidine', 'clonidine and nitroglycerin', 'nitroglycerin']","['tidal carbon dioxide pressure and intraocular pressure', 'mean arterial pressure, intraocular pressure, and end-tidal carbon dioxide pressure', 'heart rate and blood pressure', 'heart rate', 'hemodynamic parameters and intraocular pressure', 'heart rate, mean arterial blood pressure, end-tidal carbon dioxide pressure, and intraocular pressure']","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}]",,0.0586432,We found clonidine to be more effective than nitroglycerin at preventing changes in hemodynamic parameters and intraocular pressure induced by carbon dioxide insufflation during laparoscopic cholecystectomy.,"[{'ForeName': 'Manjaree', 'Initials': 'M', 'LastName': 'Mishra', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Shashi Prakash', 'Initials': 'SP', 'LastName': 'Mishra', 'Affiliation': 'General Surgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Sharad Kumar', 'Initials': 'SK', 'LastName': 'Mathur', 'Affiliation': 'Departments of Anesthesiology.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2014.00305']
2024,25392647,The da vinci robot system eliminates multispecialty surgical trainees' hand dominance in open and robotic surgical settings.,"BACKGROUND AND OBJECTIVES
Handedness, or the inherent dominance of one hand's dexterity over the other's, is a factor in open surgery but has an unknown importance in robot-assisted surgery. We sought to examine whether the robotic surgery platform could eliminate the effect of inherent hand preference.
METHODS
Residents from the Urology and Obstetrics/Gynecology departments were enrolled. Ambidextrous and left-handed subjects were excluded. After completing a questionnaire, subjects performed three tasks modified from the Fundamentals of Laparoscopic Surgery curriculum. Tasks were performed by hand and then with the da Vinci robotic surgical system (Intuitive Surgical, Sunnyvale, California). Participants were randomized to begin with using either the left or the right hand, and then switch. Left:right ratios were calculated from scores based on time to task completion. Linear regression analysis was used to determine the significance of the impact of surgical technique on hand dominance.
RESULTS
Ten subjects were enrolled. The mean difference in raw score performance between the right and left hands was 12.5 seconds for open tasks and 8 seconds for robotic tasks (P<.05). Overall left-right ratios were found to be 1.45 versus 1.12 for the open and robot tasks, respectively (P<.05). Handedness significantly differed between robotic and open approaches for raw time scores (P<.0001) and left-right ratio (P=.03) when controlling for the prior tasks completed, starting hand, prior robotic experience, and comfort level. These findings remain to be validated in larger cohorts.
CONCLUSION
The robotic technique reduces hand dominance in surgical trainees across all task domains. This finding contributes to the known advantages of robotic surgery.",2014,"Handedness significantly differed between robotic and open approaches for raw time scores (P<.0001) and left-right ratio (P=.03) when controlling for the prior tasks completed, starting hand, prior robotic experience, and comfort level.","['Ten subjects were enrolled', 'Residents from the Urology and Obstetrics/Gynecology departments were enrolled']",['robotic surgery platform'],"['raw time scores', 'raw score performance', 'Overall left-right ratios']","[{'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0587481', 'cui_str': 'Gynecology department (environment)'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",10.0,0.0388637,"Handedness significantly differed between robotic and open approaches for raw time scores (P<.0001) and left-right ratio (P=.03) when controlling for the prior tasks completed, starting hand, prior robotic experience, and comfort level.","[{'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Badalato', 'Affiliation': 'Department of Urology, Columbia University, College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Edan', 'Initials': 'E', 'LastName': 'Shapiro', 'Affiliation': 'Department of Urology, Columbia University, College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Rothberg', 'Affiliation': 'Department of Urology, Columbia University, College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Bergman', 'Affiliation': 'Department of Urology, Columbia University, College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'RoyChoudhury', 'Affiliation': 'Department of Biostatistics, Columbia University, Mailman School of Public Health, New York, New York, USA.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Korets', 'Affiliation': 'Department of Urology, Columbia University, College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Trushar', 'Initials': 'T', 'LastName': 'Patel', 'Affiliation': 'Department of Urology, Columbia University, College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Ketan K', 'Initials': 'KK', 'LastName': 'Badani', 'Affiliation': 'Department of Urology, Columbia University, College of Physicians and Surgeons, New York, New York, USA.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2014.00399']
2025,25392671,Prospective randomized comparison between transperitoneal laparoscopic pyeloplasty and retroperitoneoscopic pyeloplasty for primary ureteropelvic junction obstruction.,"BACKGROUND AND OBJECTIVES
To compare laparoscopic transperitoneal versus retroperitoneoscopic pyeloplasty for primary ureteropelvic junction obstruction in a prospective randomized manner and assess overall results with long-term follow-up.
METHODS
In this prospective study, from 2008 to 2012, 112 cases of primary ureteropelvic junction obstruction were randomized in a 1:1 ratio into 2 groups. Group I included patients who underwent transperitoneal laparoscopic pyeloplasty, and group II consisted of patients who underwent retroperitoneoscopic laparoscopic pyeloplasty. Demographic and clinical characteristics and postoperative and operative data were collected and analyzed. The statistical analysis was performed with the Fisher exact test, χ2 test, and Mann-Whitney U test for independent groups, and P<.05 was considered statistically significant.
RESULTS
The total operative time and intracorporeal suturing time were significantly higher in group II than in group I (P<.001). The visual analog scale score for pain on postoperative day 1 and the requirement for tramadol were significantly higher in group I than in group II (P=.004). The hospital stay and the rate of temporary ileus were significantly greater (P<.036 and P<.02, respectively) in group I than in group II. The success rate of transperitoneal laparoscopic pyeloplasty versus retroperitoneoscopic laparoscopic pyeloplasty was 96.4% versus 96.6% with a mean follow-up period of 30.75±4.85 months versus 30.99±5.59 months (P<.88).
CONCLUSION
Transperitoneal laparoscopic pyeloplasty is associated with significantly greater postoperative pain, a higher tramadol dose, a higher rate of ileus, and a longer hospital stay in comparison with retroperitoneoscopic laparoscopic pyeloplasty. Although the operative time for retroperitoneoscopic laparoscopic pyeloplasty is significantly longer, the success rate remains the same for both procedures.",2014,"The hospital stay and the rate of temporary ileus were significantly greater (P<.036 and P<.02, respectively) in group I than in group II.","['primary ureteropelvic junction obstruction', 'from 2008 to 2012, 112 cases of primary ureteropelvic junction obstruction']","['transperitoneal laparoscopic pyeloplasty versus retroperitoneoscopic laparoscopic pyeloplasty', 'transperitoneal laparoscopic pyeloplasty and retroperitoneoscopic pyeloplasty', 'retroperitoneoscopic laparoscopic pyeloplasty', 'laparoscopic transperitoneal versus retroperitoneoscopic pyeloplasty', 'transperitoneal laparoscopic pyeloplasty', 'Transperitoneal laparoscopic pyeloplasty']","['hospital stay and the rate of temporary ileus', 'success rate', 'postoperative pain', 'visual analog scale score for pain', 'hospital stay', 'total operative time and intracorporeal suturing time']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0521619', 'cui_str': 'Pelvi-ureteric junction obstruction'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0205501', 'cui_str': 'Transperitoneal approach (qualifier value)'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}, {'cui': 'C3697103', 'cui_str': 'Laparoscopic reconstruction of ureteropelvic junction by retroperitoneal approach (procedure)'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0527495,"The hospital stay and the rate of temporary ileus were significantly greater (P<.036 and P<.02, respectively) in group I than in group II.","[{'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': ""Department of Urology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Rahul Janak', 'Initials': 'RJ', 'LastName': 'Sinha', 'Affiliation': ""Department of Urology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Dheeraj Kumar', 'Initials': 'DK', 'LastName': 'Gupta', 'Affiliation': ""Department of Urology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': ""Department of Urology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Pandey', 'Affiliation': ""Department of Radiodiagnosis, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Akhtar', 'Affiliation': ""Department of Psychiatry, King George's Medical University, Lucknow, India.""}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2014.00366']
2026,25191187,Does preoperative gabapentin affects the characteristics of post-dural puncture headache in parturients undergoing cesarean section with spinal anesthesia?,"BACKGROUND
Gabapentin is effective for treating different types of headache including post-dural puncture headache (PDPH), also used for prophylaxis against migraine. We studied the effect of pre-operative administration of gabapentin on the characteristics of PDPH in parturients undergoing cesarean section (CS) under spinal anesthesia.
MATERIALS AND METHODS
Women undergoing elective cesarean section under spinal anesthesia were randomized to receive preoperative gabapentin 600 mg or placebo. Spinal anesthesia was achieved with 12.5 mg hyperbaric bupivacaine plus 25 μg fentanyl. Babies were followed up by Apgar scores, umbilical artery blood gases, breastfeeding difficulties, and need for NICU admission. The mothers were followed up for any side-effects of gabapentin for 24 h. Patients with PDPH were re-admitted and onset and duration of the headache were reported and severity was assessed using a visual analog scale (VAS) for 4 days from diagnosis. Paracetamol with caffeine and diclofenac were given for treatment, and the doses were adjusted according to VAS; also number of doses given for each group was recorded.
RESULTS
Eighty eight patients were randomized, and 2 were excluded. The incidence of headache and co-existing symptoms were similar in both groups. The onset of headache was significantly delayed in gabapentin group (P < 0.05). Also, severity and duration of headache were significantly less in gabapentin group (P < 0.05). The incidence of sedation was more in gabapentin group 11 (26.19%) versus placebo group 3 (6.81%). Neonatal outcomes were statistically insignificant between both groups.
CONCLUSION
Pre-operative administration of gabapentin has no effect on incidence of (PDPH) but delays its onset and reduces its severity and duration in parturients undergoing cesarean section with spinal anesthesia without significant adverse effects on the mother or the baby.",2014,The incidence of sedation was more in gabapentin group 11 (26.19%) versus placebo group 3 (6.81%).,"['Women undergoing elective cesarean section under spinal anesthesia', 'parturients undergoing cesarean section (CS) under spinal anesthesia', 'parturients undergoing cesarean section with', 'Eighty eight patients were randomized, and 2 were excluded', 'parturients undergoing cesarean section with spinal anesthesia']","['gabapentin', 'hyperbaric bupivacaine', 'placebo', 'Paracetamol with caffeine and diclofenac', 'spinal anesthesia', 'preoperative gabapentin 600 mg or placebo', 'Gabapentin']","['Neonatal outcomes', 'severity and duration of headache', 'visual analog scale (VAS', 'incidence of headache and co-existing symptoms', 'Apgar scores, umbilical artery blood gases, breastfeeding difficulties, and need for NICU admission', 'incidence of sedation', 'onset of headache']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2978027', 'cui_str': 'gabapentin 600 MG [Gralise]'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding (finding)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}]",88.0,0.110189,The incidence of sedation was more in gabapentin group 11 (26.19%) versus placebo group 3 (6.81%).,"[{'ForeName': 'Walid Hamed', 'Initials': 'WH', 'LastName': 'Nofal', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Sidky', 'Initials': 'MS', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Azza Atef Abd', 'Initials': 'AA', 'LastName': 'Al Alim', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ain Shams University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136433']
2027,25191192,Evaluation of bupivacaine-clonidine combination for unilateral spinal anesthesia in lower limb below-knee orthopedic surgery.,"BACKGROUND AND OBJECTIVES
The purposes of this study were to evaluate the onset, quality and duration of sensory and motor blockade between hyperbaric bupivacaine and clonidine combination with bupivacaine alone when administered intrathecally for unilateral spinal anesthesia in below-knee orthopedic surgery, efficacy of clonidine for post-operative analgesia and side-effects of clonidine, if any.
METHODS
Sixty ASA I and ASA II patients scheduled for elective surgery with time duration up to 90 min were studied. Patients were randomised in two equal groups by the lottery method. Group A (control group) was given Inj. bupivacaine (hyperbaric) 0.5% - 12.5 mg (2.5 ml) + 0.5 ml of normal saline intrathecally. Group B (clonidine group) was given Inj. bupivacaine (hyperbaric) 0.5% - 12.5 mg (2.5 ml) + 50 mcg clonidine in 0.5 ml volume intrathecally.
RESULTS
The mean peak sensory block was earlier in Group B (4.7±1.23 min) as compared with Group A (6.27±1.51 min). The mean peak motor block was earlier in Group B (6.17±1.20 min) as compared with Group A (8.63±1.71 min). The two-segment regression of sensory block was longer in Group B (106.23±9.17 min) as compared with Group A (104.43±17.75 min), which is clinically significant. Requirement of rescue analgesia was considerably prolonged in Group B (450.33±95.10 min) as compared with Group A (220±36.36 min), which was also clinically highly significant.
CONCLUSION
Intrathecal clonidine potentiates bupivacaine induced spinal sensory block and, motor block and reduces the analgesic requirement in the early post-operative period in unilateral spinal anesthesia for lower limb below knee surgery.",2014,"The two-segment regression of sensory block was longer in Group B (106.23±9.17 min) as compared with Group A (104.43±17.75 min), which is clinically significant.","['unilateral spinal anesthesia in lower limb below-knee orthopedic surgery', 'unilateral spinal anesthesia in below-knee orthopedic surgery', 'Sixty ASA']","['hyperbaric bupivacaine and clonidine', 'bupivacaine (hyperbaric) 0.5% - 12.5 mg (2.5 ml) + 50 mcg clonidine', 'bupivacaine', 'clonidine', 'bupivacaine (hyperbaric) 0.5% - 12.5 mg (2.5 ml) + 0.5 ml of normal saline intrathecally', 'bupivacaine-clonidine combination', 'Group B (clonidine']","['mean peak sensory block', 'analgesic requirement', 'sensory block', 'mean peak motor block', 'spinal sensory block and, motor block']","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",60.0,0.122126,"The two-segment regression of sensory block was longer in Group B (106.23±9.17 min) as compared with Group A (104.43±17.75 min), which is clinically significant.","[{'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Sapate', 'Affiliation': 'Department of Anesthesia, Pad. Dr. D.Y. Patil Medical College, Dr. D.Y. Patil Vidyapeeth, Hospital and Research Centre, Pimpri, Pune, Maharastra, India.'}, {'ForeName': 'Preety', 'Initials': 'P', 'LastName': 'Sahu', 'Affiliation': 'Department of Anesthesia, Pad. Dr. D.Y. Patil Medical College, Dr. D.Y. Patil Vidyapeeth, Hospital and Research Centre, Pimpri, Pune, Maharastra, India.'}, {'ForeName': 'Bhavini', 'Initials': 'B', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesia, Pad. Dr. D.Y. Patil Medical College, Dr. D.Y. Patil Vidyapeeth, Hospital and Research Centre, Pimpri, Pune, Maharastra, India.'}, {'ForeName': 'Chhaya', 'Initials': 'C', 'LastName': 'Suryawanshi', 'Affiliation': 'Department of Anesthesia, Pad. Dr. D.Y. Patil Medical College, Dr. D.Y. Patil Vidyapeeth, Hospital and Research Centre, Pimpri, Pune, Maharastra, India.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Anesthesia, Pad. Dr. D.Y. Patil Medical College, Dr. D.Y. Patil Vidyapeeth, Hospital and Research Centre, Pimpri, Pune, Maharastra, India.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Panditrao', 'Affiliation': 'Department of Anesthesia, Pad. Dr. D.Y. Patil Medical College, Dr. D.Y. Patil Vidyapeeth, Hospital and Research Centre, Pimpri, Pune, Maharastra, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136626']
2028,25191179,Evaluation of gabapentin and dexamethasone alone or in combination for pain control after adenotonsillectomy in children.,"BACKGROUND
Different methods and many drugs have been used to control the post-operative pain. In this study, we evaluate the role of gabapentin premedication and/or dexamethasone in management of post-operative pain following adenotonsillectomy in children.
MATERIALS AND METHODS
In a double-blind randomized study, 120 children were subjected for adenotonsillectomy classified into three equal groups. Group G: Gabapentin 10 mg/kg was given orally 2 h before induction of anesthesia (Gabapentin syrup 250 mg/5 ml. Group D: Children in this group received placebo pre-operatively and received dexamethasone 0.15 mg/kg intravenously after induction of anesthesia, but before surgery. Group C: Children in this group received combination of oral gabapentin 10 mg/kg 2 h before induction of anesthesia and intra-operative 0.15 mg/kg dexamethasone intravenously. All children underwent general anesthesia. Pain score was assisted post-operatively 2 h, 4 h, 6 h, 8 h, 12 h and 18 h after recovery using face, legs, activity, cry, consolability scale.
RESULTS
Pain score in Group C and Group G was significantly less at 4 h, 6 h and 8 h post-operatively than in Group D (P < 0.05). At 12 h, the pain score in Group C was significantly less than Group G and Group D (P < 0.05). And no significant changes were observed in pain score at 18 h post-operatively between all groups (P > 0.05). The time to first analgesia was longer in the Group C than in Group G and Group D and the time to first analgesia was significantly longer in Group G than in Group D (P < 0.05). The total amount of pethidine was less in Group C and Group G than in Group D (P < 0.05). The incidence of post-operative nausea and vomiting was statically insignificant among all groups and no reported post-operative bleeding.
CONCLUSION
Gabapentin 10 mg/kg premedication combined with intra-operative dexamethasone 0.15 mg/kg prolongs the post-operative analgesia following adenotonsillectomy in children and decreases the amount of pethidine used post-operatively with no reported adverse effects or increase in the incidence of post-operative bleeding.",2014,"The incidence of post-operative nausea and vomiting was statically insignificant among all groups and no reported post-operative bleeding.
","['All children underwent general anesthesia', '120 children were subjected for adenotonsillectomy classified into three equal groups', 'pain control after adenotonsillectomy in children', 'adenotonsillectomy in children', 'Group D']","['combination of oral gabapentin 10 mg/kg 2 h before induction of anesthesia and intra-operative 0.15 mg/kg dexamethasone', 'placebo', 'dexamethasone', 'anesthesia (Gabapentin syrup', 'gabapentin premedication and/or dexamethasone', 'gabapentin and dexamethasone', 'Gabapentin']","['Pain score', 'total amount of pethidine', 'pain score', 'time to first analgesia', 'face, legs, activity, cry, consolability scale', 'incidence of post-operative nausea and vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",120.0,0.0591397,"The incidence of post-operative nausea and vomiting was statically insignificant among all groups and no reported post-operative bleeding.
","[{'ForeName': 'Sabry Mohammad', 'Initials': 'SM', 'LastName': 'Amin', 'Affiliation': 'Department of Anesthesia, Tanta University Hospital, Faculty of Medicine, Tanta 31527, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136417']
2029,25191180,Epidural dexamethasone for post-operative analgesia in patients undergoing abdominal hysterectomy: A dose ranging and safety evaluation study.,"AIM
Number of studies revealed that epidural bupivacaine-dexamethasone has the same analgesic potency as bupivacaine-fentanyl with opioid sparing and antiemetic effects. Different doses of dexamethasone were used in different studies. This study was designed to evaluate the optimum dose of epidural dexamethasone for post-operative analgesia.
MATERIALS AND METHODS
In this double-blinded randomized controlled study, we evaluated the efficiency and safety of different doses of epidural dexamethasone for post-operative analgesia in 160 patients aged 45-60 years scheduled for total abdominal hysterectomy. Patient were randomly allocated into four groups to receive a total volume of 10 ml epidural plain bupivacaine 0.25% in the control group (Group D0) with either 4 mg dexamethasone in (Group D4) or 6 mg dexamethasone in (Group D6) or 8 mg dexamethasone in (Group D8). Patients then received general anesthesia. Sedation, satisfaction and visual analog pain scores (VAS) at rest and with effort were measured post-operatively. Meperidine was administered when VAS > or = 4. Intra-operative fentanyl dose, post-operative meperidine consumption and the time to first analgesic requirement were recorded by a blinded observer. Blood glucose was measured pre-operatively and at 4 h and 8 h after study drug administration. Wound healing and infection were assessed after 1 week.
RESULTS
Intraoperative fentanyl requirements were comparable among groups. The time to first analgesic requirement was significantly prolonged 5.5 times in D8 Group but only 1.5 times in D6 and D4 Groups more than the analgesic duration in the control Group D0, with a P < 0.01. There was a significant reduction in post-operative meperidine consumption during the first 24 h in the D8 (75%) in comparison with D6 and D4 Groups (50%), respectively, (P < 0.01) and the control Group D0 (0%) (P < 0.01). VAS scores were significantly lower and patient satisfaction score was significantly higher in the D8 and compared with Groups D6 and D4 (P < 0.01) and the control Group D0 (P < 0.01). Post-operative nausea was significantly lower in the D8, D6 and D4 Groups versus the D0 Group (P < 0.05).
CONCLUSION
Epidural dexamethasone in a dose of 8 mg is probably more effective than lower doses to control moderate to severe post-operative pain. This dose is not associated with increased glucose level or delayed wound healing.",2014,"Post-operative nausea was significantly lower in the D8, D6 and D4 Groups versus the D0 Group (P < 0.05).
","['160 patients aged 45-60 years scheduled for total abdominal hysterectomy', 'patients undergoing abdominal hysterectomy']","['Meperidine', 'total volume of 10 ml epidural plain bupivacaine', 'dexamethasone', 'Epidural dexamethasone', 'bupivacaine', 'general anesthesia', 'epidural dexamethasone', 'bupivacaine-dexamethasone']","['efficiency and safety', 'post-operative meperidine consumption', 'patient satisfaction score', 'Wound healing and infection', 'Blood glucose', 'Post-operative nausea', 'time to first analgesic requirement', 'VAS scores', 'Sedation, satisfaction and visual analog pain scores (VAS']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}]","[{'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",160.0,0.110127,"Post-operative nausea was significantly lower in the D8, D6 and D4 Groups versus the D0 Group (P < 0.05).
","[{'ForeName': 'Amira Fathy', 'Initials': 'AF', 'LastName': 'Hefni', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed Sidky', 'Initials': 'MS', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Azza Atef Abd', 'Initials': 'AA', 'LastName': 'Al Alim', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Ain Shams University Hospitals, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136420']
2030,25191181,"Tracheal tube cuff inflation guided by pressure volume loop closure associated with lower postoperative cuff-related complications: Prospective, randomized clinical trial.","BACKGROUND
The main function of an endotracheal tube (ETT) cuff is to prevent aspiration. High cuff pressure is usually associated with postoperative complications. We tried to compare cuff inflation guided by pressure volume loop closure (PV-L) with those by just to seal technique (JS) and assess the postoperative incidence of sore throat, cough and hoarseness.
MATERIALS AND METHODS
In a prospective, randomized clinical trial, 100 patients' tracheas were intubated. In the first group (n = 50), ETT cuff inflation was guided by PV-L, while in the second group (n. = 50) the ETT cuff was inflated using the JS technique. Intracuff pressures and volumes were measured. The incidence of postoperative cuff-related complications was reported.
RESULTS
Demographic data and durations of intubation were comparable between the groups. The use of PV-L was associated with a lesser amount of intracuff air [4.05 (3.7-4.5) vs 5 (4.8-5.5), P < 0.001] and lower cuff pressure than those in the JS group [18.25 (18-19) vs 33 (32-35), P ≤ 0.001]. The incidence of postextubation cuff-related complications was significantly less frequent among the PV-L group patients as compared with the JS group patients (P ≤ 0.009), except for hoarseness of voice, which was less frequent among the PV-L group, but not statistically significant (P ≤ 0.065). Multiple regression models for prediction of intra-cuff pressure after intubation and before extubation revealed a statistically significant association with the technique used for cuff inflation (P < 0.0001).
CONCLUSIONS
The study confirms that PV-L-guided ETT cuff inflation is an effective way to seal the airway and associates with a lower ETT cuff pressure and lower incidence of cuff-related complications.",2014,"The incidence of postextubation cuff-related complications was significantly less frequent among the PV-L group patients as compared with the JS group patients (P ≤ 0.009), except for hoarseness of voice, which was less frequent among the PV-L group, but not statistically significant (P ≤ 0.065).","[""100 patients' tracheas were intubated""]","['PV-L-guided ETT cuff inflation', 'endotracheal tube (ETT) cuff', 'Tracheal tube cuff inflation guided by pressure volume loop closure', 'cuff inflation guided by pressure volume loop closure (PV-L) with those by just to seal technique (JS']","['lower cuff pressure', 'hoarseness of voice', 'Demographic data and durations of intubation', 'High cuff pressure', 'incidence of postoperative cuff-related complications', 'postoperative incidence of sore throat, cough and hoarseness', 'Intracuff pressures and volumes', 'incidence of postextubation cuff-related complications']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040578', 'cui_str': 'Trachea'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff, device (physical object)'}, {'cui': 'C0428735', 'cui_str': 'Pressure volume loop (observable entity)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",100.0,0.0247552,"The incidence of postextubation cuff-related complications was significantly less frequent among the PV-L group patients as compared with the JS group patients (P ≤ 0.009), except for hoarseness of voice, which was less frequent among the PV-L group, but not statistically significant (P ≤ 0.065).","[{'ForeName': 'Waleed A', 'Initials': 'WA', 'LastName': 'Almarakbi', 'Affiliation': 'Department of Anesthesia and Critical Care, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia ; Department of Anesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Kaki', 'Affiliation': 'Department of Anesthesia and Critical Care, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136422']
2031,25191184,Comparison between the intravenous and caudal routes of sufentanil in children undergoing orchidopexy and further evaluation of the association of caudal adrenaline and neostigmine.,"BACKGROUND
The aim of this study was to compare the intravenous (IV) and caudal routes of administration of sufentanil for children undergoing orchidopexy and also to evaluate the effects on addition of caudal adrenaline and neostigmine.
MATERIALS AND METHODS
SIXTY PATIENTS SCHEDULED FOR ORCHIDOPEXY WERE DIVIDED INTO THE FOLLOWING GROUPS: 1) Group IVSu received IV 0.5 μg/kg sufentanil and caudal saline; 2) Group CSu received caudal 0.5 μg/kg sufentanil and IV saline; 3) Group CSuAdr received caudal sufentanil plus adrenaline 5 μg/ml (1:200,000) and IV saline; 4) Group CSuNeo received caudal sufentanil plus neostigmine, and IV saline; and 5) Group CSuNeoAdr received caudal sufentanil plus neostigmine plus adrenaline, and IV saline. Heart rate and mean blood pressure >15% was treated with increasing isoflurane concentration. Consumption of isoflurane, side effects, quality of sleep, time to first administration of analgesic, and number of doses of 24-h rescue analgesic were recorded.
RESULTS
Groups were demographically similar. Isoflurane consumption showed the following association: Group IVSu = Group CSuNeo = Group CSuNeoAdr < Group CSu = Group CSuAdr (P < 0.02). VAS for sedation on reversal of anesthesia showed the following association: Group CSuNeo = Group CSuNeoAdr < Group CSu = Group CSuAdr = Group IVSu (P < 0.005). Time to the first administration of dipyrone showed the following association: Group IVSu = Group CSu = Group CSuAdr (3-4 h) < Group CSuNeo = Group CSuNeoAdr (10-11 h) (P < 0.05). Number of doses of rescue analgesic showed the following association: Group IVSu = Group CSu = Group CSuAdr > Group CSuNeo = Group CSuNeoAdr (P < 0.005). Incidence of adverse effects was similar among groups.
CONCLUSION
Caudal sufentanil alone was no better than when administered in the IV route, and would just be justified by the association of neostigmine, but not adrenaline. Neostigmine association resulted in better perioperative analgesia.",2014,"Incidence of adverse effects was similar among groups.
",['children undergoing orchidopexy'],"['caudal adrenaline and neostigmine', 'caudal sufentanil plus adrenaline 5 μg/ml (1:200,000) and IV saline; 4) Group CSuNeo received caudal sufentanil plus neostigmine, and IV saline; and 5) Group CSuNeoAdr received caudal sufentanil plus neostigmine plus adrenaline, and IV saline', 'neostigmine', 'VAS', 'Caudal sufentanil', 'sufentanil', 'Neostigmine', 'dipyrone', 'sufentanil and caudal saline; 2) Group CSu received caudal 0.5 μg/kg sufentanil and IV saline']","['Incidence of adverse effects', 'Isoflurane consumption', 'perioperative analgesia', 'Heart rate and mean blood pressure', 'Consumption of isoflurane, side effects, quality of sleep, time to first administration of analgesic, and number of doses of 24-h rescue analgesic']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0194907', 'cui_str': 'Orchidopexy'}]","[{'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3714569', 'cui_str': 'METAMIZOLE SODIUM'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",60.0,0.144484,"Incidence of adverse effects was similar among groups.
","[{'ForeName': 'Gabriela Rocha', 'Initials': 'GR', 'LastName': 'Lauretti', 'Affiliation': 'Department of Biomechanics, Medicine and Rehabilitation of Locomotor Members, Teaching Hospital, School of Medicine of Ribeirão Preto, University of São Paulo, Brazil.'}, {'ForeName': 'Vera Maria Silveira', 'Initials': 'VM', 'LastName': 'de Azevedo', 'Affiliation': 'Department of Anesthesiology, FacultySchool of Medicine, University of Tiradentes, Sergipe, Brazil.'}, {'ForeName': 'Bruno Carvalho', 'Initials': 'BC', 'LastName': 'Portes Lopes', 'Affiliation': 'Department of Biomechanics, Medicine and Rehabilitation of Locomotor Members, Teaching Hospital, School of Medicine of Ribeirão Preto, University of São Paulo, Brazil.'}, {'ForeName': 'Anita Leocadia', 'Initials': 'AL', 'LastName': 'de Mattos', 'Affiliation': 'Department of Biomechanics, Medicine and Rehabilitation of Locomotor Members, Teaching Hospital, School of Medicine of Ribeirão Preto, University of São Paulo, Brazil.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136430']
2032,25191189,"Pain relief in day care arthroscopic knee surgery: A comparison between intra-articular ropivacaine and levobupivacaine: A prospective, double-blinded, randomized controlled study.","BACKGROUND
Post-operative pain frequently hampers implementation of day care arthroscopic knee surgery in spite of so many analgesic, local anesthetic drugs and routes of administration.
AIMS
The aim of the present study was carried out to compare the efficacy of ropivacaine and levobupivacaine when administered through intra-articular route in controlling pain after day care arthroscopic knee surgery.
SETTING AND DESIGN
It was a prospective, double-blinded and randomized controlled study.
MATERIALS AND METHODS
April 2008-December 2008, 60 patients of both sex, of American Society of Anesthesiologists physical status I and II, undergoing day care arthroscopic knee surgery were randomly assigned into two groups (R, L). Group R received 10 ml of 0.75% ropivacaine, whereas group L received 10 ml of 0.50% levobupivacaine through intra-articular route at the end of the procedure. Pain assessed using visual analog scale (VAS) and diclofenac sodium given as rescue analgesia when VAS >3. Time of first analgesic request and total rescue analgesic were calculated.
STATISTICAL ANALYSIS AND RESULTS
based on comparable demographic profiles; time for the requirement of first post-operative rescue analgesia (242.16 ± 23.86 vs. 366.62 ± 24.42) min and total mean rescue analgesic requirement was (104.35 ± 18.96 vs. 76.82 ± 14.28) mg in group R and L respectively. Group R had higher mean VAS score throughout the study period. No side effects found among the groups. These two results were clinically and statistically significant (P < 0.05).
CONCLUSION
Hence, it was evident that intra-articular levobupivacaine give better post-operative pain relief, with an increase in time of first analgesic request and decreased need of total post-operative analgesia compared with ropivacaine.",2014,No side effects found among the groups.,"['controlling pain after day care arthroscopic knee surgery', 'April 2008-December 2008, 60 patients of both sex, of American Society of Anesthesiologists physical status I and II, undergoing day care arthroscopic knee surgery', 'day care arthroscopic knee surgery']","['ropivacaine', 'levobupivacaine', 'diclofenac sodium', 'ropivacaine and levobupivacaine']","['Pain assessed using visual analog scale (VAS', 'Pain relief', 'total mean rescue analgesic requirement', 'time of first analgesic request and decreased need of total post-operative analgesia', 'Time of first analgesic request and total rescue analgesic', 'mean VAS score']","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0873129,No side effects found among the groups.,"[{'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine & Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Ratul', 'Initials': 'R', 'LastName': 'Kundu', 'Affiliation': 'Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapobrata', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Bangur Institute of Neurology, Kolkata, West Bengal, India.'}, {'ForeName': 'Anindya', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Bimal Kumar', 'Initials': 'BK', 'LastName': 'Hajra', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Soumyadip', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Orthopedics, R.G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of G & O, College of Medicine & Sagore Dutta Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136435']
2033,25191190,"Comparing the effect of pregabalin, gabapentin, and acetaminophen on post-dural puncture headache.","INTRODUCTION
Post-dural puncture headache (PDPH) is a common complication of lumbar puncture for any purpose. To avoid the need for invasive methods of treating PDPH such as blood patch, the search for novel pharmacological agents to manage PDPH continues. The aim of this study was to compare the effects of acetaminophen, gabapentin and pregabalin in controlling PDPH in patients who underwent surgery under spinal anesthesia.
MATERIALS AND METHODS
A total of 90 patients who underwent elective orthopedic surgery under spinal anesthesia and suffered from PDPH consequently were enrolled in this randomized trial. Patients were categorized randomly into three groups. Group A, B and C have received Acetaminophen, Gabapentin and Pregabalin (3 times a day for 3 days), respectively. The effect of medications on the severity of PDPH was evaluated and compared using visual analog scale (VAS).
RESULTS
The mean VAS score was significantly lower in pregabalin group compared with others 24, 48 and 72 h after the onset of headache (P = 0.001 for all of them) and lower in Gabapentin group compared with Acetaminophen group 24, 48 and 72 h after the onset of headache (P = 0.001 for all analyses). No adverse outcome was reported in groups.
CONCLUSION
Pregabalin and gabapentin are both useful and safe in management of PDPH, but pregabalin is more effective in this regard.",2014,"The mean VAS score was significantly lower in pregabalin group compared with others 24, 48 and 72 h after the onset of headache (P = 0.001 for all of them) and lower in Gabapentin group compared with Acetaminophen group 24, 48 and 72 h after the onset of headache (P = 0.001 for all analyses).","['90 patients who underwent elective orthopedic surgery under spinal anesthesia and suffered from PDPH consequently were enrolled', 'patients who underwent surgery under spinal anesthesia']","['acetaminophen, gabapentin and pregabalin', 'pregabalin', 'pregabalin, gabapentin, and acetaminophen', 'Acetaminophen, Gabapentin and Pregabalin', 'Pregabalin and gabapentin', 'Acetaminophen', 'Gabapentin']","['post-dural puncture headache', 'visual analog scale (VAS', 'adverse outcome', 'mean VAS score', 'severity of PDPH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",90.0,0.102366,"The mean VAS score was significantly lower in pregabalin group compared with others 24, 48 and 72 h after the onset of headache (P = 0.001 for all of them) and lower in Gabapentin group compared with Acetaminophen group 24, 48 and 72 h after the onset of headache (P = 0.001 for all analyses).","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mahoori', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Imam Khomeini Training Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Heydar', 'Initials': 'H', 'LastName': 'Noroozinia', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Imam Khomeini Training Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Hasani', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Imam Khomeini Training Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Saghaleini', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Imam Khomeini Training Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136436']
2034,25191191,Comparative study between computed tomography guided superior hypogastric plexus block and the classic posterior approach: A prospective randomized study.,"CONTEXT
The classic posterior approach to superior hypogastric plexus block (SHPB) is sometimes hindered by the iliac crest or a prominent transverse process of L5. The computed tomography (CT) - guided anterior approach might overcome these difficulties.
AIMS
This prospective, comparative, randomized study was aimed to compare the CT guided anterior approach versus the classic posterior approach.
SETTINGS AND DESIGN
Controlled randomized study.
MATERIALS AND METHODS
A total of 30 patients with chronic pelvic cancer pain were randomized into either classic or CT groups where classic posterior approach or CT guided anterior approach were done, respectively. Visual analog score, daily analgesic morphine consumed and patient satisfaction were assessed just before the procedure, then, after 24 h, 1 week and monthly for 2 months after the procedure. Duration of the procedure was also recorded. Adverse effects associated with the procedure were closely observed and recorded.
STATISTICAL ANALYSIS USED
Student's t-test was used for comparison between groups.
RESULTS
Visual analog scale and morphine consumption decreased significantly in both groups at the measured times after the block compared with the baseline in the same group with no significant difference between both groups. The procedure was carried out in significantly shorter duration in the CT group than that in the classic group. The mean patient satisfaction scale increased significantly in both groups at the measured times after the block compared with the baseline in the same group. The patients in the CT groups were significantly more satisfied than those in classic group from day one after the procedure until the end of the study.
CONCLUSIONS
The CT guided approach for SHPB is easier, faster, safer and more effective, with less side-effects than the classic approach.",2014,"RESULTS
Visual analog scale and morphine consumption decreased significantly in both groups at the measured times after the block compared with the baseline in the same group with no significant difference between both groups.",['30 patients with chronic pelvic cancer pain'],"['SHPB', 'CT', 'CT guided anterior approach', 'classic or CT', 'computed tomography guided superior hypogastric plexus block', 'computed tomography (CT) - guided anterior approach']","['Adverse effects', 'Visual analog score, daily analgesic morphine consumed and patient satisfaction', 'Visual analog scale and morphine consumption', 'mean patient satisfaction scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0751416', 'cui_str': 'Cancer of Pelvis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach (qualifier value)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0229047', 'cui_str': 'Structure of superior hypogastric plexus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}]",30.0,0.0288623,"RESULTS
Visual analog scale and morphine consumption decreased significantly in both groups at the measured times after the block compared with the baseline in the same group with no significant difference between both groups.","[{'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Ghoneim', 'Affiliation': 'Department of Anesthesia and Pain Relief, National Cancer Institute, Cairo, Egypt.'}, {'ForeName': 'Sahar M', 'Initials': 'SM', 'LastName': 'Mansour', 'Affiliation': ""Department of Radiology Women's Imaging Unit, Faculty of Medicine, Cairo University, Cairo, Egypt.""}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136625']
2035,24665245,Effect of continuous magnesium sulfate infusion on spinal block characteristics: A prospective study.,"BACKGROUND
Spinal anesthesia is an established mode of anesthesia for lower limb orthopedic surgeries. The limitations of the technique are short duration of action and limited post-operative analgesia. Concomitant use of intravenous infusion of magnesium sulfate may have an effect on the block characteristics and duration of action of intrathecal bupivacaine.
METHODS
A total of 80 American Society of Anesthesiologists I and II patients, either sex, 20-60 years of age scheduled for elective orthopedic fixation of fracture of long bones of lower limbs under spinal anesthesia were included. Spinal anesthesia administered with 2.5 ml heavy bupivacaine mixed with 10 mcg fentanyl. The groups were then divided to receive an infusion of injection magnesium sulfate 50 mg/kg/h over 15 min followed by 15 mg/kg/h until the end of the surgery (Group M) and 15 ml of Normal Saline over 15 min followed by 100 ml/h until the end of surgery (Group S). Onset, duration of sensory and motor block and amount of post-operative analgesic were noted.
RESULTS
A total of 6 patients (Group M) and seven patients (Group S) had inadequate block and excluded from the study. Mean block height was T6. Time required to achieve block height was 8.82 min versus 7.42 min in Groups M and S respectively (P = 0.04). Mean duration of motor block was longer in group M (160.63 ± 17.76 min) compared with Group S (130.12 ± 20.70 min) (P = 0.000). Time for regression of sensory block to T12/L1was 206.88 ± 20.96 min (Group M) and 163.88 ± 15.46 min (Group S) (P = 0.000). Hemodynamic parameters were similar and statistically not significant. Need for first analgesic requirement was after 262.88 ± 21.11 min in group M and 193.25 ± 17.74 min in the group S (P = 0.000). Mean dosage of tramadol needed in first 24 h was less in group M (190 ± 30.38 mg vs. 265 ± 48.30 mg, P = 0.000).
CONCLUSION
Use of intravenous magnesium with spinal anesthesia reduces post-operative pain and analgesic consumption.",2014,Mean duration of motor block was longer in group M (160.63 ± 17.76 min) compared with Group S (130.12 ± 20.70 min) (P = 0.000).,"['spinal block characteristics', '80 American Society of Anesthesiologists I and II patients, either sex, 20-60 years of age scheduled for elective orthopedic fixation of fracture of long bones of lower limbs under spinal anesthesia were included', '6 patients (Group M) and seven patients (Group S) had inadequate block and excluded from the study']","['injection magnesium sulfate 50 mg/kg/h over 15 min followed by 15 mg/kg/h until the end of the surgery (Group M) and 15 ml of Normal Saline', 'magnesium sulfate', 'Spinal anesthesia administered with 2.5 ml heavy bupivacaine mixed with 10 mcg fentanyl', 'continuous magnesium sulfate infusion', 'magnesium with spinal anesthesia']","['Hemodynamic parameters', 'Mean duration of motor block', 'Onset, duration of sensory and motor block and amount of post-operative analgesic', 'Time required to achieve block height', 'post-operative pain and analgesic consumption', 'Mean dosage of tramadol', 'Mean block height']","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016641', 'cui_str': 'Fracture Reduction'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",80.0,0.0871985,Mean duration of motor block was longer in group M (160.63 ± 17.76 min) compared with Group S (130.12 ± 20.70 min) (P = 0.000).,"[{'ForeName': 'Akansha', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Department of Anesthesia, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Anesthesia, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Yashwant S', 'Initials': 'YS', 'LastName': 'Payal', 'Affiliation': 'Department of Anesthesia, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125945']
2036,24665242,Intrathecal fentanyl as an adjuvant to 0.75% isobaric ropivacaine for infraumbilical surgery under subarachnoid block: A prospective study.,"BACKGROUND
Subarachnoid blockade can be used in all surgical procedures carried out on the infraumbilical region. This study was aimed to evaluate the clinical efficacy and safety of intrathecal fentanyl as an adjuvant to 0.75% isobaric ropivacaine on onset, duration, intensity, and recovery time of sensory and motor blockade of subarachnoid block for infra umbilical surgery.
METHODS
One hundred sixty adult consented patients of either gender with American Society of Anesthesiologist ASA I and II scheduled for infraumbilical surgery were randomized into two groups of 80 patients each to receive either intrathecal study solution of 4 mL of 0.75% ropivacaine with 0.4 mL of 0.9% sodium chloride (Group I-Ropivacaine Control Group RC) or fentanyl (20 μg) (Group II-Ropivacaine with Fentanyl RF). The end points were hemodynamic variability, onset of analgesia at T 10, maximum sensory analgesic level, time to complete motor blockade, duration of sensory and motor blockade and adequacy of surgical anesthesia. The post-spinal nausea and vomiting, shivering, pruritus, respiratory depression or any other side-effects were also assessed. At the end of study, data were systematically complied and analyzed for statistically significance.
RESULT
The intrathecal fentanyl has accelerated the onset time to achieve sensory blockade to T10 dermatome and motor blockade. Small dose of intrathecal fentanyl with ropivacaine has prolonged the duration of analgesia in the early post-operative period when compared with intrathecal ropivacaine alone. The intraoperative hemodynamic variability showed no statistically significant differences between groups.
CONCLUSION
Intrathecal fentanyl as an adjuvant to 0.75% isobaric ropivacaine demonstrated better clinical profile as compared to ropivacaine alone.",2014,Intrathecal fentanyl as an adjuvant to 0.75% isobaric ropivacaine demonstrated better clinical profile as compared to ropivacaine alone.,"['infraumbilical surgery under subarachnoid block', 'One hundred sixty adult consented patients of either gender with American Society of Anesthesiologist ASA I and II scheduled for infraumbilical surgery']","['intrathecal study solution of 4 mL of 0.75% ropivacaine with 0.4 mL of 0.9% sodium chloride', 'Ropivacaine Control Group RC) or fentanyl (20 μg) (Group II-Ropivacaine with Fentanyl RF', 'intrathecal fentanyl', 'Intrathecal fentanyl', 'ropivacaine', 'isobaric ropivacaine']","['post-spinal nausea and vomiting, shivering, pruritus, respiratory depression or any other side-effects', 'intraoperative hemodynamic variability', 'hemodynamic variability, onset of analgesia at T 10, maximum sensory analgesic level, time to complete motor blockade, duration of sensory and motor blockade and adequacy of surgical anesthesia', 'onset, duration, intensity, and recovery time of sensory and motor blockade of subarachnoid block', 'duration of analgesia', 'clinical efficacy and safety']","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",160.0,0.102389,Intrathecal fentanyl as an adjuvant to 0.75% isobaric ropivacaine demonstrated better clinical profile as compared to ropivacaine alone.,"[{'ForeName': 'Kumkum', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology and Critical Care, N.S.C.B. Subharti Medical College, Swami Vivekananda Subharti University, Subhartipuram, NH-58, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Surjeet', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology and Critical Care, N.S.C.B. Subharti Medical College, Swami Vivekananda Subharti University, Subhartipuram, NH-58, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesiology and Critical Care, N.S.C.B. Subharti Medical College, Swami Vivekananda Subharti University, Subhartipuram, NH-58, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Prashant K', 'Initials': 'PK', 'LastName': 'Gupta', 'Affiliation': 'Department of Radio-diagnosis, Imaging and Interventional Radiology, N.S.C.B. Subharti Medical College, Swami Vivekananda Subharti University, Subhartipuram, NH-58, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Krishan', 'Affiliation': 'Department of Surgery, N.S.C.B. Subharti Medical College, Swami Vivekananda Subharti University, Subhartipuram, NH-58, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Pandey', 'Affiliation': 'Department of Anaesthesiology and Critical Care, N.S.C.B. Subharti Medical College, Swami Vivekananda Subharti University, Subhartipuram, NH-58, Meerut, Uttar Pradesh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125939']
2037,24665243,"Effect of auditory stimulation on traumatic coma duration in intensive care unit of Medical Sciences University of Mazandarn, Iran.","BACKGROUND
Sensory deprivation is one of the common complications of coma patients in the intensive care unit (ICU). The purpose of this study was to investigate the impact of a familiar voice to consciousness level in coma patients.
METHODS
A total of 13 patients with traumatic coma (8 ≥ Glasgow's coma scale [GCS]) admitted in ICU ward were randomly assigned to control and experimental groups. The experimental group was treated twice a daily each time 15 min with a familiar recorded MP3 sound for 2 weeks. The control group received only natural voices of environment. GCS applied to evaluate patients' level of consciousness.
FINDING
Findings showed that duration to reach GCS = 15 was significantly shorter in the experimental group (χ(2) = 12/96, P < 0/001).
CONCLUSION
These findings imply that providing familiar auditory stimulation programs for coma patients in the ICU could be effective.",2014,Findings showed that duration to reach GCS = 15 was significantly shorter in the experimental group (χ(2) =,"['coma patients', ""13 patients with traumatic coma (8 ≥ Glasgow's coma scale [GCS]) admitted in ICU ward"", 'coma patients in the intensive care unit (ICU', 'traumatic coma duration in intensive care unit of Medical Sciences University of Mazandarn, Iran']","['natural voices of environment', 'GCS', 'auditory stimulation']",[],"[{'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0394016', 'cui_str': 'Coma, Traumatic'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}]",[],13.0,0.025172,Findings showed that duration to reach GCS = 15 was significantly shorter in the experimental group (χ(2) =,"[{'ForeName': 'Mohammad Ali Heidari', 'Initials': 'MA', 'LastName': 'Gorji', 'Affiliation': 'Nursing and Midwifery Department, Medical Science University of Mazandaran, Sari, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Araghiyansc', 'Affiliation': 'Nursing and Midwifery Department, Medical Science University of Mazandaran, Sari, Iran.'}, {'ForeName': 'Hadayat', 'Initials': 'H', 'LastName': 'Jafari', 'Affiliation': 'Nursing and Midwifery Department, Medical Science University of Mazandaran, Sari, Iran.'}, {'ForeName': 'Ali Morad Heidari', 'Initials': 'AM', 'LastName': 'Gorgi', 'Affiliation': 'Nursing and Midwifery Department, Medical Science University of Mazandaran, Sari, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Yazdani', 'Affiliation': 'Nursing and Midwifery Department, Medical Science University of Mazandaran, Sari, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125940']
2038,24680148,Transvaginal endoscopic surgery for tubal ectopic pregnancy.,"OBJECTIVE
To explore the feasibility, safety, efficacy, and cosmetic outcomes of transvaginal endoscopic salpingectomy for tubal ectopic pregnancy.
METHODS
From May 2009 to May 2012, we prospectively enrolled 40 patients, each of whom had been scheduled for a salpingectomy because of a tubal ectopic pregnancy, and randomized them into two groups: transvaginal endoscopic surgery and laparoscopic approach. We recorded the estimated blood loss, time of anal exhaust, postoperative pain score, length of stay, and scar assessment scale associated with transvaginal endoscopic access (n = 18) (natural orifice transluminal endoscopic surgery) and laparoscopic salpingectomy (n = 20) (control group) for tubal ectopic pregnancy. The transvaginal salpingectomy was performed with a double-channel endoscope through a vaginal puncture. A single surgeon performed the surgical procedures in patients in both groups.
RESULTS
The group that underwent the transvaginal endoscopic procedure reported lesser pain at all postoperative visits than the group that underwent the laparoscopic approach. The duration of time for transvaginal endoscopic surgery was slightly longer than that for the laparoscopic approach. However, there was no statistically significant difference between the two groups in the duration of operative time. The group that underwent transvaginal endoscopic surgery was more satisfied with the absence of an external scar than the group that underwent the laparoscopic procedure, which left a scar. The estimated blood loss, time of anal exhaust, and length of stay were the same in both groups.
CONCLUSION
The safety and efficacy of transvaginal endoscopic salpingectomy for tubal ectopic pregnancy are equivalent to those of the laparoscopic procedure. Lesser postoperative pain and a more satisfactory cosmetic outcome were found with the transvaginal endoscopic procedure, making it the more preferred method and superior to the laparoscopic approach.",2014,The group that underwent the transvaginal endoscopic procedure reported lesser pain at all postoperative visits than the group that underwent the laparoscopic approach.,"['From May 2009 to May 2012, we prospectively enrolled 40 patients, each of whom had been scheduled for a salpingectomy because of a tubal ectopic pregnancy', 'tubal ectopic pregnancy', 'patients in both groups']","['transvaginal salpingectomy was performed with a double-channel endoscope', 'Transvaginal endoscopic surgery', 'transvaginal endoscopic procedure', 'transvaginal endoscopic salpingectomy', 'transvaginal endoscopic surgery', 'transvaginal endoscopic surgery and laparoscopic approach']","['estimated blood loss, time of anal exhaust, and length of stay', 'Lesser postoperative pain', 'tubal ectopic pregnancy', 'estimated blood loss, time of anal exhaust, postoperative pain score, length of stay, and scar assessment scale associated with transvaginal endoscopic access (n = 18) (natural orifice transluminal endoscopic surgery) and laparoscopic salpingectomy', 'lesser pain at all postoperative visits', 'safety and efficacy', 'feasibility, safety, efficacy, and cosmetic outcomes', 'duration of operative time', 'duration of time for transvaginal endoscopic surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0032987', 'cui_str': 'Ectopic Pregnancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0041271', 'cui_str': 'Tubectomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0231226', 'cui_str': 'Exhausting (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032987', 'cui_str': 'Ectopic Pregnancy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2936208', 'cui_str': 'Natural Orifice Transluminal Endoscopic Surgery'}, {'cui': 'C1282523', 'cui_str': 'Laparoscopic salpingectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0580703', 'cui_str': 'Postoperative visit (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}]",40.0,0.0666332,The group that underwent the transvaginal endoscopic procedure reported lesser pain at all postoperative visits than the group that underwent the laparoscopic approach.,"[{'ForeName': 'Boqun', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Obstetrics and Gynecology, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yawen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Digestive Endoscopy & Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ying', 'Affiliation': 'Department of Obstetrics and Gynecology, Second Affiliated Hospital of Nanjing Medical University, 121 Jiang Jia Yuan, Xia Guan Qu, Nanjing 210011, China. xiaoyanying@yahoo.com.'}, {'ForeName': 'Zhining', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': ""Department of Obstetrics and Gynecology, Northern Jiangsu People's Hospital, Yangzhou, China.""}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680813X13693422519875']
2039,24665246,"A comparison of granisetron and nitroglycerine for attenuating rocuronium pain: A double-blinded randomized, placebo controlled trial.","BACKGROUND
The incidence of pain reported in literature after IV administration of rocuronium is 50-80%. The aim of our study was to determine whether pre-treatment with intravenous granisetron and nitroglycerine would reduce rocuronium-induced pain.
METHODS
One hundred fifty patients of either sex, aged 18-65 years, American society of Anaesthesiologist grading (ASA) I-II, scheduled for various surgeries under general anesthesia were randomly assigned to one of the groups. Group G: received 2 granisetron (1mg/ml) diluted with 3 ml of 0.9% normal saline) while the Group C: received 5 ml of 0.9% normal saline. Group N: received 200΅g of nitroglycerine diluted to a total of 5 ml(with 0.9% normal saline). It was accompanied by manual venous occlusion for 20 seconds. Then 0.06mg/kg of rocuronium was injected through same cannula over 10-15 sec. Patients were asked by a blinded investigator to score the pain on injection of rocuronium using visual analogue scale (0-10) with 0-no pain,1-3 mild pain, 4-6 moderate and >=7 severe pain. At the same time discomfort in the form of patient's movement, such as no movement (grade 0), movement only wrist (grade 1), movement to the upper arm and shoulder of injected arm (grade 2) or generalized movements (grade3) was observed. Statistical analysis using independent t test, Mann-Whitney test and reverse ANOVA was done.
RESULTS
1. At 0 seconds, in group G number of patients who experienced withdrawl score of 0-1 were 92%,group N were 82% while only 26% of patients in group C had favourable withdrawl score.74% of patients in group C had score of 2-3 at same time. 2. At 0 sec, in group G number of patients who experienced VAS score of 0-3 were 96%, group N 72%. At same time Group C 48 % of patients had VAS score of 2-3.
CONCLUSION
We conclude that pre-treatment with granisetron or nitroglycerine both are highly effective in attenuation of rocuronium induced pain.",2014,N were 82% while only 26% of patients in group C had favourable withdrawl,"['using visual analogue scale (0-10) with 0-no pain,1-3 mild pain, 4-6 moderate and >=7 severe pain', 'One hundred fifty patients of either sex, aged 18-65 years, American society of Anaesthesiologist grading (ASA) I-II, scheduled for various surgeries under general anesthesia']","['granisetron or nitroglycerine', 'placebo', 'granisetron (1mg/ml) diluted with 3 ml of 0.9% normal saline) while the Group C: received 5 ml of 0.9% normal saline', 'rocuronium', 'nitroglycerine diluted to a total of 5 ml(with 0.9% normal saline', 'granisetron and nitroglycerine']","['favourable withdrawl', 'VAS score', 'rocuronium pain']","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",150.0,0.586164,N were 82% while only 26% of patients in group C had favourable withdrawl,"[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Goyal', 'Affiliation': 'Department of Anesthesia, Himalyan Institute of Medical Sciences, Jolly Grant, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Jindal', 'Affiliation': 'Department of Anesthesia, Himalyan Institute of Medical Sciences, Jolly Grant, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Gurjeet', 'Initials': 'G', 'LastName': 'Khurana', 'Affiliation': 'Department of Anesthesia, Himalyan Institute of Medical Sciences, Jolly Grant, Dehradun, Uttarakhand, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125948']
2040,24665247,Efficacy of spinal ropivacaine versus ropivacaine with fentanyl in transurethral resection operations.,"BACKGROUND
The low-dose ropivacaine provides differential spinal block to reduce adverse hemodynamic effects in elderly patients. Addition of intrathecal fentanyl with ropivacaine may enhance analgesia and early postoperative mobility. The present study was performed to evaluate the efficacy of intrathecal ropivacaine alone and in combination with fentanyl in transurethral resection operation.
METHODS
Sixty male patients aged >50 years of ASA I-III scheduled for elective transurethral resection were included in a prospective, randomized, double-blinded study and they were divided in two groups of 30 each. Group A (n = 30) received intrathecal injection of ropivacaine 2 ml (0.75%) and Group B (n = 30) ropivacaine 1.8 ml (0.75%) with fentanyl 10 μg. The characteristics of onset and regression of sensory and motor blockade, hemodynamic stability, and side effects were observed. Student's t test (for parametric data) and Mann-Whitney U test (for non-parametric data) were used for statistical analyses.
RESULTS
There were no significant differences between the two groups for patient demographic data, intraoperative hemodynamic parameters, side effects, and satisfaction to patients and surgeon. The highest level of sensory block was at T10 in group A and T9 in group B (P = 0.001). Duration of motor block was longer in group B being 210.51 ± 61.25 min than in group A being 286.25 ± 55.65 min (P < 0.001).
CONCLUSION
The addition of fentanyl to ropivacaine may offer the advantage of shorter duration of complete motor block, hemodynamic stability, and without any increase in the frequency of major side effects.",2014,"There were no significant differences between the two groups for patient demographic data, intraoperative hemodynamic parameters, side effects, and satisfaction to patients and surgeon.","['Sixty male patients aged >50 years of ASA I-III scheduled for', 'elderly patients', 'transurethral resection operations']","['intrathecal injection of ropivacaine', 'elective transurethral resection', 'ropivacaine with fentanyl', 'spinal ropivacaine', 'fentanyl', 'intrathecal fentanyl', 'ropivacaine', 'intrathecal ropivacaine']","['highest level of sensory block', 'shorter duration of complete motor block, hemodynamic stability', 'frequency of major side effects', 'analgesia and early postoperative mobility', 'patient demographic data, intraoperative hemodynamic parameters, side effects, and satisfaction', 'Duration of motor block', 'sensory and motor blockade, hemodynamic stability, and side effects', 'adverse hemodynamic effects']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0021896', 'cui_str': 'Injections, Intrathecal'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",60.0,0.140194,"There were no significant differences between the two groups for patient demographic data, intraoperative hemodynamic parameters, side effects, and satisfaction to patients and surgeon.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chaudhary', 'Affiliation': ""Department of Anesthesia, KG's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bogra', 'Affiliation': ""Department of Anesthesia, KG's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Singh', 'Affiliation': ""Department of Anesthesia, KG's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': ""Department of Anesthesia, KG's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chandra', 'Affiliation': ""Department of Anesthesia, KG's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': ""Department of Anesthesia, KG's Medical University, Lucknow, Uttar Pradesh, India.""}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125951']
2041,24665232,"Low-dose ketamine infusion for labor analgesia: A double-blind, randomized, placebo controlled clinical trial.","BACKGROUND
Most primary and secondary level hospitals in developing countries provide inadequate labor analgesia due to various medical, technical and economic reasons. This clinical trial was an effort to study the efficacy, safety and feasibility of intravenous (IV) ketamine to provide labor analgesia.
MATERIALS AND METHODS
A total of 70 parturients were consented and randomly assigned to receive either IV ketamine or 0.9% saline. A loading dose of ketamine (0.2 mg/kg) was followed-by an infusion (0.2 mg/kg/h) until the delivery of the neonate. Similar volume of saline was infused in the placebo-group. Intramuscular meperidine was the rescue analgesic in both groups. The pain score, hemodynamic parameters of mother and fetus and the anticipated side-effects of ketamine were observed for. The newborn was assessed by the Neonatologist.
RESULTS
The pain score showed a decreasing trend in the ketamine group and after the 1(st) h more than 60% of women in the ketamine group had pain relief, which was statistically significant. There was no significant clinical change in the maternal hemodynamics and fetal heart rate. However, 17 (48.5%) of them had transient light headedness in the ketamine group. All the neonates were breast fed and the umbilical cord blood pH was between 7.1 and 7.2. The overall satisfaction was significantly high in the intervention group (P = 0.028).
CONCLUSION
A low-dose ketamine infusion (loading dose of 0.2 mg/kg delivered over 30 min, followed-by an infusion at 0.2 mg/kg/h) could provide acceptable analgesia during labor and delivery.",2014,"The pain score showed a decreasing trend in the ketamine group and after the 1(st) h more than 60% of women in the ketamine group had pain relief, which was statistically significant.","['A total of 70 parturients', 'labor analgesia']","['Intramuscular meperidine', 'placebo', 'IV ketamine or 0.9% saline', 'intravenous (IV) ketamine', 'ketamine']","['overall satisfaction', 'maternal hemodynamics and fetal heart rate', 'efficacy, safety and feasibility', 'transient light headedness', 'pain score', 'pain relief', 'umbilical cord blood pH', 'pain score, hemodynamic parameters of mother and fetus and the anticipated side-effects of ketamine']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018811', 'cui_str': 'Heart Rate, Fetal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0220870', 'cui_str': 'Lightheadedness'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]",70.0,0.40054,"The pain score showed a decreasing trend in the ketamine group and after the 1(st) h more than 60% of women in the ketamine group had pain relief, which was statistically significant.","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Joel', 'Affiliation': 'Department of Surgery, Christian Medical College & Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Joselyn', 'Affiliation': 'Department of Anesthesia, Christian Medical College & Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Verghese T', 'Initials': 'VT', 'LastName': 'Cherian', 'Affiliation': 'Department of Anesthesiology, Milton S Hershey Medical Center, PA, USA.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Nandhakumar', 'Affiliation': 'Department of Anesthesia and Pain Management, Mount Sinai Hospital, Toronto, Canada.'}, {'ForeName': 'Nithin', 'Initials': 'N', 'LastName': 'Raju', 'Affiliation': 'Department of Anesthesia, Christian Medical College & Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Ilamurugu', 'Initials': 'I', 'LastName': 'Kaliaperumal', 'Affiliation': 'Department of Anesthesia, The Queen Elizabeth Hospital, Adelaide, South Australia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125897']
2042,24665233,Use of oral tramadol to prevent perianesthetic shivering in patients undergoing transurethral resection of prostate under subarachnoid blockade.,"CONTEXT
Under regional anesthesia, geriatric patients are prone to shivering induced perioperative complications that Anesthesiologists should prevent rather than treat.
AIM
We investigated the prophylactic efficacy of oral tramadol 50 mg to prevent the perioperative shivering after transurethral resection of prostate (TURP) surgery under subarachnoid blockade (SAB). Shivering is usually overlooked in patients undergoing urological surgery under spinal anesthesia and may result in morbidity, prolonged hospital stay and increased financial burden. Use of prophylactic measures to reduce shivering in geriatric patients who undergo urological procedures could circumvent this. Oral formulation of tramadol is a universally available cost-effective drug with the minimal side-effects.
SETTINGS AND DESIGN
Prospective, randomized, double-blinded, placebo-controlled study.
PATIENTS AND METHODS
A total of 80 patients who were scheduled for TURP surgery under subarachnoid block were randomly selected. Group I and II (n = 40 each) received oral tramadol 50 mg and placebo tablet respectively. After achieving subarachnoid block, the shivering, body temperature (tympanic membrane, axillary and forehead), hemodynamic parameters and arterial saturation were recorded at regular intervals.
STATISTICAL ANALYSIS USED
T-test, analysis of variance test, Z-test and Fisher exact test were utilized while Statistical Product and Service Solutions, IBM, Chicago (SPSS statistics (version 16.0)), software was used for analysis.
RESULTS
Incidence of shivering was significantly less in patients who received tramadol (7.5% vs. 40%; P < 0.01). The use of tramadol was associated with clinically inconsequential side-effects.
CONCLUSION
We conclude that the use of oral tramadol 50 mg is effective as a prophylactic agent to reduce the incidence, severity and duration of perioperative shivering in patients undergoing TURP surgery under SAB.",2014,"RESULTS
Incidence of shivering was significantly less in patients who received tramadol (7.5% vs. 40%; P < 0.01).","['patients undergoing urological surgery under spinal anesthesia', '80 patients who were scheduled for TURP surgery under subarachnoid block', 'geriatric patients who undergo urological procedures', 'after transurethral resection of prostate (TURP) surgery under subarachnoid blockade (SAB', 'patients undergoing TURP surgery under SAB', 'patients undergoing transurethral resection of prostate under subarachnoid blockade']","['oral tramadol 50 mg and placebo', 'oral tramadol', 'tramadol', 'placebo']","['prophylactic efficacy', 'perianesthetic shivering', 'perioperative shivering', 'Incidence of shivering', 'shivering, body temperature (tympanic membrane, axillary and forehead), hemodynamic parameters and arterial saturation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0041445', 'cui_str': 'Eardrum'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",80.0,0.147406,"RESULTS
Incidence of shivering was significantly less in patients who received tramadol (7.5% vs. 40%; P < 0.01).","[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Tewari', 'Affiliation': 'Department of Anesthesiology, Dayanand Medical College, Ludhiana, India.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Dhawan', 'Affiliation': 'Department of Anesthesiology, Dayanand Medical College, Ludhiana, India.'}, {'ForeName': 'Vidhi', 'Initials': 'V', 'LastName': 'Mahendru', 'Affiliation': 'Department of Anesthesiology, Dayanand Medical College, Ludhiana, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Katyal', 'Affiliation': 'Department of Anesthesiology, Dayanand Medical College, Ludhiana, India.'}, {'ForeName': 'Avtar', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesiology, Dayanand Medical College, Ludhiana, India.'}, {'ForeName': 'Shuchita', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Anesthesiology, Dayanand Medical College, Ludhiana, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125898']
2043,24665234,Comparison of nasal Midazolam with Ketamine versus nasal Midazolam as a premedication in children.,"BACKGROUND
This study was done to compare effects of intranasal midazolam and intranasal midazolam with ketamine for premedication of children aged 1-12 yrs undergoing intermediate and major surgeries.
AIMS
Midazolam and Ketamine have already been used as premedicants in children. Our aim was to find out advantage of combination of midazolam with ketamine over midazolam by nasal route.
METHODS
Sixty children of age group 1-12 yrs of American Society of Anesthesiologists (ASA) grade 1 and 2 were selected. Group A- midazolam (0.2 mg/kg), Group B- midazolam (0.15 mg/kg + ketamine 1 mg/kg). Both groups received drug intranasally 30 min before surgery in recovery room with monitored anesthesia care. Onset of sedation, sedation score, emotional reaction, intravenous cannula acceptance, and mask acceptance were studied.
STATISTICAL ANALYSIS
Unpaired t test and chi square test.
RESULTS
Sedation score, anxiolysis, attitude, reaction to intravenous cannulation, face mask acceptance, and emotional reaction were significantly better in midazolam with ketamine group. Intra operatively, in both groups, pulse rate, oxygen saturation, and respiratory rate had no significant difference; also, post operatively, no significant difference was observed in above parameters, post operative analgesia was significantly better in midazolam with ketamine group.
CONCLUSIONS
Intra nasal premedication allows rapid and predictable sedation in children. Midazolam as well as combination of Midazolam with ketamine gives good level of sedation and comfort. But quality of sedation, analgesia, and comfort is significantly better in midazolam with ketamine group. No significant side effects were observed in both groups.",2014,"Intra operatively, in both groups, pulse rate, oxygen saturation, and respiratory rate had no significant difference; also, post operatively, no significant difference was observed in above parameters, post operative analgesia was significantly better in midazolam with ketamine group.
","['Sixty children of age group 1-12 yrs of American Society of Anesthesiologists (ASA) grade 1 and 2 were selected', 'children aged 1-12 yrs undergoing intermediate and major surgeries', 'children']","['Midazolam with ketamine', 'Midazolam', 'nasal Midazolam with Ketamine', 'midazolam with ketamine', 'midazolam', 'intranasal midazolam and intranasal midazolam', 'Group B- midazolam', 'ketamine', 'Ketamine', 'Group A- midazolam', 'nasal Midazolam']","['side effects', 'quality of sedation, analgesia, and comfort', 'operative analgesia', 'pulse rate, oxygen saturation, and respiratory rate', 'Sedation score, anxiolysis, attitude, reaction to intravenous cannulation, face mask acceptance, and emotional reaction', 'Onset of sedation, sedation score, emotional reaction, intravenous cannula acceptance, and mask acceptance']","[{'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1961138', 'cui_str': 'Anxiolysis'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0398266', 'cui_str': 'Introduction of catheter into vein'}, {'cui': 'C0180823', 'cui_str': 'Face mask (physical object)'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]",60.0,0.0686978,"Intra operatively, in both groups, pulse rate, oxygen saturation, and respiratory rate had no significant difference; also, post operatively, no significant difference was observed in above parameters, post operative analgesia was significantly better in midazolam with ketamine group.
","[{'ForeName': 'Sonal S', 'Initials': 'SS', 'LastName': 'Khatavkar', 'Affiliation': 'Department of Anesthesiology, Padmashree Dr. Dnyandeo Yashwantrao Patil Medical College, Hospital and Research Centre, Nerul, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Rochana G', 'Initials': 'RG', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Anesthesiology, Padmashree Dr. Dnyandeo Yashwantrao Patil Medical College, Hospital and Research Centre, Nerul, Navi Mumbai, Maharashtra, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125904']
2044,24665236,"PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study.","BACKGROUND
postoperative nausea and vomiting (PONV) frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens.
AIMS
the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery.
SETTING AND DESIGN
it was a prospective, double blinded, and randomized controlled study.
METHODS
124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62) receiving (IV) Ondansetron (4 mg)] and Group B [(n=62) receiving IV Ramosetron (0.3 mg)] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6, 12, and 18 h postoperatively.
STATISTICAL ANALYSIS AND RESULTS
statistically significant difference between Groups A and B (P <0.05) was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity.
CONCLUSION
it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg) has better efficacy than single dose IV Ondansetron (4 mg) in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.",2014,"statistically significant difference between Groups A and B (P <0.05) was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity.
","['Ambulatory surgery', 'patients undergoing day-care surgery under general anesthesia', '124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery']","['Ramosetron', 'PONV', 'IV Ramosetron', 'Ondansetron', 'Ramosetron and Ondansetron']","['episodes of PONV', 'Episodes of PONV']","[{'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0526950', 'cui_str': 'ramosetron'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]",124.0,0.239984,"statistically significant difference between Groups A and B (P <0.05) was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity.
","[{'ForeName': 'Debasis', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': 'Department of Anaesthesiology, MNC and H, Berhampur, West Bengal, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'C.M.S.D.H, Kolkata, West Bengal, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Rahul Deb', 'Initials': 'RD', 'LastName': 'Mandal', 'Affiliation': 'Department of G and O, Burdwan Medical College, Burdwan, West Bengal, India.'}, {'ForeName': 'Soumyadip', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Orthopedics, R.G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Anindya', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Chakraborty', 'Affiliation': 'C.M.S.D.H, Kolkata, West Bengal, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'C.M.S.D.H, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125917']
2045,24665237,A comparison between over-the-head and lateral cardiopulmonary resuscitation with a single rescuer by bag-valve mask.,"CONTEXT
mask fixation in the lateral position is difficult during CPR.
AIM
the aim of this study is to compare the lateral CPR for the use of bag-valve mask by single paramedic rescuer as well as over-the-head CPR on the chest compression and ventilation on the manikin.
SETTINGS AND DESIGN
Mazandaran University of Medical Sciences. The design of this study was a randomized cross-over trial.
METHODS
participants learned a standardized theoretical introduction CPR according to the 2010 guidelines. The total number of chest compressions per two minutes was measured. Total number of correct and wrong ventilation per two minutes was evaluated.
STATISTICAL ANALYSIS
we used Wilcoxon signed-rank test to analyze the non-normally distributed data in dependence groups A. P-value of more than 0.05 was considered to show statistical significance.
RESULTS
there were 100 participants (45 women and 55 men) who participated in the study from September to March, 2011. The compression and ventilation rate in lateral CPR was lower than OTH CPR. Around 51% of participants had correct chest compression rate more than 90 beats per minute in lateral CPR and 65% of them had equal or more than ten correct ventilations per minute.
CONCLUSIONS
in conclusion, this study confirmed that in a simulated CPR model over-the-head position CPR led to a better BLS than the lateral position CPR by a single paramedic student with a BVM device. We also concluded that by this new BVM fixation method on the face of the patients in the lateral position CPR can be a good alternative over-the-head mask fixation by a single trained rescuer.",2014,Around 51% of participants had correct chest compression rate more than 90 beats per minute in lateral CPR and,"['Mazandaran University of Medical Sciences', 'participants learned a standardized theoretical introduction CPR according to the 2010 guidelines', '100 participants (45 women and 55 men) who participated in the study from September to March, 2011']",[],"['Total number of correct and wrong ventilation', 'total number of chest compressions', 'compression and ventilation rate in lateral CPR', 'correct chest compression rate']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]",45.0,0.0245496,Around 51% of participants had correct chest compression rate more than 90 beats per minute in lateral CPR and,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Nasiri', 'Affiliation': 'Department Anesthesiology and Emergency Medicine, Faculty Member, Traditional and Complementary Medicine Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Nasiri', 'Affiliation': 'Medical Student, Medical Student Research Committee, Ramsar, Mazandaran University of Medical Sciences, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125923']
2046,24665238,Lornoxicam versus tramadol for post-operative pain relief in patients undergoing ENT procedures.,"BACKGROUND
Pain following ear-nose and throat surgery is one of the most important complaints for which, several drugs are used. This prospective, randomized, double-blind controlled trial was designed to compare the analgesic effect of tramadol versus lornoxicam for post-operative pain relief in patients undergoing ENT surgical procedures.
METHODS
One hundred and twenty patients of ASA class I-II, who had undergone elective ENT surgical procedures under general anesthesia, were assigned in a randomized manner into three equal groups. Group L received lornoxicam8 mg IV, Group T received tramadol 1 mg/kg IV and Group C received IV saline after induction of anesthesia before the start of the surgery. Post-operative pain was assessed using the visual analogue scale (VAS) and sedation level was evaluated during stay in the post-anesthesia care unit with a four-point sedation scale. Intraoperative blood loss was estimated using the Five-Point Scale. Adverse events in the first 24 h post-operative were recorded.
RESULTS
The VAS pain scores were significantly higher in Group C as compared with those in Groups L and T at 30 min and 1, 2, 4and 6 h post-operatively, with no significant difference between Group L and Group T. The amount of morphine consumption post-operatively was significantly lower in Group L (5.2 ± 2.5 mg) and Group T (5.0 ± 2.0 mg) as compared with that in Group C (7.4 ± 2.3 mg) (P = 0.001). The time for the first analgesic requirement was significantly less in Group L (92.62 ± 24.23 min) and Group T (88 ± 21.43 min) as compared with that in Group C (42.82 ± 25.61 min), with no significant difference between the other two groups. Estimated intraoperative blood loss score by the surgeons showed no significant difference between the three groups. The most frequent side-effects in the three groups were nausea and vomiting, and their incidence was significantly higher in the placebo group as compared with the other two groups.
CONCLUSION
Tramadol 1 mg/kg was comparable to lornoxicam 8 mg for post-operative pain relief in patients undergoing ENT surgical procedures; both drugs helped to reduce the post-operative opioid requirement and consequently minimized the related adverse effects of the opioids.",2014,"The VAS pain scores were significantly higher in Group C as compared with those in Groups L and T at 30 min and 1, 2, 4and 6 h post-operatively, with no significant difference between Group L and Group T.","['patients undergoing ENT procedures', 'patients undergoing ENT surgical procedures', 'One hundred and twenty patients of ASA class I-II, who had undergone elective ENT surgical procedures under general anesthesia']","['placebo', 'lornoxicam8', 'lornoxicam', 'tramadol', 'Lornoxicam', 'IV saline', 'Tramadol']","['visual analogue scale (VAS) and sedation level', 'Adverse events', 'time for the first analgesic requirement', 'VAS pain scores', 'amount of morphine consumption post-operatively', 'nausea and vomiting, and their incidence', 'analgesic effect', 'Intraoperative blood loss', 'Estimated intraoperative blood loss score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274038', 'cui_str': 'Ear, nose and throat surgery'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0055477', 'cui_str': 'lornoxicam'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",120.0,0.0552726,"The VAS pain scores were significantly higher in Group C as compared with those in Groups L and T at 30 min and 1, 2, 4and 6 h post-operatively, with no significant difference between Group L and Group T.","[{'ForeName': 'Ashraf A', 'Initials': 'AA', 'LastName': 'Abdelhalim', 'Affiliation': 'Department of Anesthesiology, Alexandria University, Egypt and King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Al Harethy', 'Affiliation': 'Department of ENT, King Abdul Aziz University Hospital, Collage of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Moustafa', 'Affiliation': 'Department of Anesthesiology, Assiut University, Egypt, Consultant, King Saud University, Riyadh, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125935']
2047,24665239,Ring block with levobupivacaine 0.25% and paracetamol vs. paracetamol alone in children submitted to three different surgical techniques of circumcision: A prospective randomized study.,"BACKGROUND
circumcision in children is a painful procedure. We aim compare the intraoperative and postoperative efficacy of three different surgical procedures of the ring block using levobupivacaine 0.25% combined with rectal paracetamol as opposed to rectal paracetamol alone.
METHODS
the study included 106 boys scheduled to undergo circumcision. The patients were randomly assigned within two groups to receive either ring block with levobupivacaine 0.25% and rectal paracetamol 30 mg/kg, or rectal paracetamol 30 mg/kg alone. The following surgical procedures were performed: sutureless proctoplasty, preputial plasty, and conventional circumcision. The efficacy of intraoperative analgesia was estimated on the basis of increases in heart rate and mean arterial pressure. Postoperatively, children were assessed for pain, pain-free (PF) period, and the total doses of analgesics administered during hospitalization, on the day after discharge, and on the first and second postoperative days.
RESULTS
all children remained stable during anesthesia. Postoperatively, the mean pain score did not show statistical differences between the groups. Children who received combined analgesia had a longer PF period (P < 0.001). However, the total doses of paracetamol administered during the observational period showed no differences. Children undergoing sutureless prepuceplasty received lower doses of paracetamol postoperatively (P < 0.001).
CONCLUSION
subcutaneous ring block either with levobupivacaine 0.25% plus rectal paracetamol or rectal paracetamol alone provides adequate intraoperative and postoperative analgesia in circumcised children. However, combined analgesia allows a longer PF period. The need for less analgesic administration in children undergoing sutureless prepuceplasty could mean that the circumcision techniques might be a mitigating factor in terms of pain.",2014,"Children undergoing sutureless prepuceplasty received lower doses of paracetamol postoperatively (P < 0.001).
","['circumcised children', 'children submitted to three different surgical techniques of circumcision', '106 boys scheduled to undergo circumcision', 'children undergoing sutureless prepuceplasty']","['sutureless proctoplasty, preputial plasty, and conventional circumcision', 'paracetamol vs. paracetamol', 'combined analgesia', 'paracetamol', 'rectal paracetamol', 'levobupivacaine 0.25% plus rectal paracetamol or rectal paracetamol', 'levobupivacaine', 'ring block with levobupivacaine 0.25% and rectal paracetamol 30 mg/kg, or rectal paracetamol 30 mg/kg alone']","['pain, pain-free (PF', 'heart rate and mean arterial pressure', 'mean pain score', 'longer PF period', 'intraoperative and postoperative efficacy']","[{'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0403330', 'cui_str': 'Prepuceplasty (procedure)'}]","[{'cui': 'C0161906', 'cui_str': 'Repair of rectum (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0857542', 'cui_str': 'Ring block'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",106.0,0.131239,"Children undergoing sutureless prepuceplasty received lower doses of paracetamol postoperatively (P < 0.001).
","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Zavras', 'Affiliation': 'Department of Surgery, ATTIKO University Hospital, Athens-Greece.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Tsamoudaki', 'Affiliation': ""Department of Pediatric Surgery, Penteli, General Children's Hospital, P. Penteli, Athens-Greece.""}, {'ForeName': 'Efstratios', 'Initials': 'E', 'LastName': 'Christianakis', 'Affiliation': ""Department of Pediatric Surgery, Penteli, General Children's Hospital, P. Penteli, Athens-Greece.""}, {'ForeName': 'Demetrios', 'Initials': 'D', 'LastName': 'Schizas', 'Affiliation': 'Department of Surgery, ATTIKO University Hospital, Athens-Greece.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Pikoulis', 'Affiliation': 'Department of Surgery, Laiko University Hospital, Athens-Greece.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kyritsi', 'Affiliation': 'Department of Nursing A, Technological and Educational Institute of Athens-Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Chrousos', 'Affiliation': ""Department of Pediatrics, Athens University Medical School, Aghia Sophia Children's Hospital, Athens-Greece.""}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125936']
2048,24665240,A comparison of the analgesic efficacy of transforaminal methylprednisolone alone and with low doses of clonidine in lumbo-sacral radiculopathy.,"BACKGROUND
Although transforaminal epidural steroid injections under fluoroscopic guidance have become a common mode of treatment of lumbosacral radiculopathy due to herniated disc, the efficacy of steroid with low doses of clonidine has not been compared yet.
OBJECTIVES
Comparison of the analgesic efficacy of methylprednisolone alone and with low doses of clonidine for transforaminal injection in lumbosacral radiculopathy.
STUDY DESIGN
A randomized, double-blind trial.
SETTING
This study was performed at the Pain Clinic under the Department of Anaesthesiology, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh, India.
METHODS
One hundred and eighty ASA grade I and II patients aged between 18 and 55 years were allocated into groups I, II and III to receive methylprednisolone 60 mg alone or methylprednisolone 60 mg with or without low doses of clonidine (0.5 mcg/kg or 1 mcg/kg) as transforaminal epidural injection. Pain relief and patient's satisfaction were evaluated with the global pain scale. Follow-up visits were advised at 1, 2, 4, 6 and 12 weeks and then at 6 months after injection. Associated complications were recorded.
RESULTS
Maximum pain relief was observed at 2 weeks after injection in all the three groups, with no difference in complication rate among the three groups. The most common complication observed was paresthesia in the nerve distribution. Greater than 60% improvement in pain scores was seen in 40% of the patients in group I, 50% of the patients in group II and 75% of the patients in group III.
LIMITATIONS
This study is limited by the lack of a placebo group.
CONCLUSION
Adding 1 mcg/kg clonidine to 60 mg methylprednisolone in transforaminal epidural injections provided better pain relief than 60 mg methylprednisolone with 0.5 mcg/kg clonidine or 60 mg methylprednisolone alone in patients suffering from lumbosacral radiculopathy, with practically no significant side-effects.",2014,"RESULTS
Maximum pain relief was observed at 2 weeks after injection in all the three groups, with no difference in complication rate among the three groups.","['One hundred and eighty ASA grade', 'lumbo-sacral radiculopathy', 'This study was performed at the Pain Clinic under the Department of Anaesthesiology, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh, India', 'I and II patients aged between 18 and 55 years', 'patients suffering from lumbosacral radiculopathy']","['transforaminal epidural injection', 'placebo', 'clonidine', 'methylprednisolone 60 mg alone or methylprednisolone 60 mg with or without low doses of clonidine', 'methylprednisolone', 'transforaminal methylprednisolone']","[""Pain relief and patient's satisfaction"", 'analgesic efficacy', 'pain scores', 'global pain scale', 'pain relief', 'Maximum pain relief', 'complication rate']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1263856', 'cui_str': 'Sacral radiculopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0242936', 'cui_str': 'Pain Centers'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0026870', 'cui_str': 'Muslims'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0154738', 'cui_str': 'Lumbosacral root lesion'}]","[{'cui': 'C0021486', 'cui_str': 'Extradural Injections'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",180.0,0.121684,"RESULTS
Maximum pain relief was observed at 2 weeks after injection in all the three groups, with no difference in complication rate among the three groups.","[{'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Tauheed', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Hammad', 'Initials': 'H', 'LastName': 'Usmani', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Anwar Hasan', 'Initials': 'AH', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Physiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125937']
2049,24665241,A randomized clinical trial comparing the efficacy and safety of ramosetron versus ondansetron in patients undergoing abdominal surgery under general anesthesia.,"BACKGROUND
Post-operative nausea and vomiting is one of the most common and distressing complications after anesthesia and surgery. It may lead to serious post-operative complications. Ramosetron is a newer 5-HT3 receptor antagonist and has more potent and longer duration of antiemetic effects compared to first generation 5HT3 receptor antagonists. The purpose of this study was to compare the efficacy of Ramosetron for the prevention of post-operative nausea and vomiting with that of Ondansetron in patients undergoing abdominal surgeries under general anesthesia.
METHODS
In this randomized, double-blind study, 60 patients, 18-60 years of both genders falling under ASA I-II category scheduled for abdominal surgery were included. Group I received I.V ramosetron 0.3 mg while group II received I.V Ondansetron 4 mg at the time of extubation. The standard general anesthetic technique was used throughout. Postoperatively the incidences of nausea, vomiting, and safety assessments were performed at 1, 2, 6, and 24 h during the first 24 h after surgery.
RESULTS
There were no differences between groups with respect to patient demographics. The percentage of patients who had complete response (no PONV, and no need for another rescue antiemetic) from 0 to 24 h after anesthesia was 56% with ramosetron and 33% with ondansetron. The corresponding rates at 1, 2, 6, and 24 h after anesthesia were 76% and 63%, 76% and 50%, 100 and 83%, 100 and 93%, respectively. Safety profiles of the two drugs were comparable, as no clinically serious adverse effects caused by study drugs were observed in either of the groups.
CONCLUSION
Our study concludes that prophylactic therapy with ramosetron is highly efficacious than ondansetron in preventing PONV in patients undergoing abdominal surgery under general anesthesia.",2014,Ramosetron is a newer 5-HT3 receptor antagonist and has more potent and longer duration of antiemetic effects compared to first generation 5HT3 receptor antagonists.,"['60 patients, 18-60 years of both genders falling under ASA I-II category scheduled for abdominal surgery were included', 'patients undergoing abdominal surgery under general anesthesia', 'patients undergoing abdominal surgeries under general anesthesia']","['Ondansetron', 'Ramosetron', 'ramosetron', 'ondansetron']","['efficacy and safety', 'nausea, vomiting, and safety assessments']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0526950', 'cui_str': 'ramosetron'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",60.0,0.177584,Ramosetron is a newer 5-HT3 receptor antagonist and has more potent and longer duration of antiemetic effects compared to first generation 5HT3 receptor antagonists.,"[{'ForeName': 'Sriramamurthy', 'Initials': 'S', 'LastName': 'Kaja', 'Affiliation': 'Department of Anesthesia, Mahadevappa Rampure Medical College, Gulbarga, Karnataka, India.'}, {'ForeName': 'Ravindra S', 'Initials': 'RS', 'LastName': 'Giri', 'Affiliation': 'Department of Anesthesia, Mahadevappa Rampure Medical College, Gulbarga, Karnataka, India.'}, {'ForeName': 'Deepak V', 'Initials': 'DV', 'LastName': 'Tugave', 'Affiliation': 'Department of Anesthesia, Mahadevappa Rampure Medical College, Gulbarga, Karnataka, India.'}, {'ForeName': 'Mukarram', 'Initials': 'M', 'LastName': 'Iqbal', 'Affiliation': 'Department of Anesthesia, Mahadevappa Rampure Medical College, Gulbarga, Karnataka, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125938']
2050,30763142,"Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer.","BACKGROUND
Darolutamide is a structurally unique androgen-receptor antagonist that is under development for the treatment of prostate cancer. We evaluated the efficacy of darolutamide for delaying metastasis and death in men with nonmetastatic, castration-resistant prostate cancer.
METHODS
We conducted a randomized, double-blind, placebo-controlled, phase 3 trial involving men with nonmetastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less. Patients were randomly assigned in a 2:1 ratio to receive darolutamide (600 mg [two 300-mg tablets] twice daily) or placebo while continuing androgen-deprivation therapy. The primary end point was metastasis-free survival, with the presence of metastasis determined by independent central review of radiographic imaging every 16 weeks.
RESULTS
In total, 1509 patients underwent randomization (955 to the darolutamide group and 554 to the placebo group). In the planned primary analysis, which was performed after 437 primary end-point events had occurred, the median metastasis-free survival was 40.4 months with darolutamide, as compared with 18.4 months with placebo (hazard ratio for metastasis or death in the darolutamide group, 0.41; 95% confidence interval, 0.34 to 0.50; P<0.001). Darolutamide was also associated with benefits with regard to all secondary end points, including overall survival, time to pain progression, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event. The incidence of adverse events that occurred or worsened during the treatment period and had a frequency of 5% or more or were of grade 3 or higher was similar in the two groups; all such events except fatigue occurred in less than 10% of patients in either group. The percentage of patients who discontinued the assigned regimen because of adverse events was 8.9% in the darolutamide group and 8.7% in the placebo group. Darolutamide was not associated with a higher incidence of seizures, falls, fractures, cognitive disorder, or hypertension than placebo.
CONCLUSIONS
Among men with nonmetastatic, castration-resistant prostate cancer, metastasis-free survival was significantly longer with darolutamide than with placebo. The incidence of adverse events was similar for darolutamide and placebo. (Funded by Bayer HealthCare and Orion Pharma; ARAMIS ClinicalTrials.gov number, NCT02200614.).",2019,"Darolutamide was not associated with a higher incidence of seizures, falls, fractures, cognitive disorder, or hypertension than placebo.
","['Nonmetastatic, Castration-Resistant Prostate Cancer', '1509 patients underwent randomization (955 to the darolutamide group and 554 to the', 'men with nonmetastatic, castration-resistant prostate cancer', 'men with nonmetastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less']","['darolutamide (600 mg [two 300-mg tablets] twice daily) or placebo while continuing androgen-deprivation therapy', 'darolutamide', 'placebo']","['metastasis-free survival', 'seizures, falls, fractures, cognitive disorder, or hypertension', 'median metastasis-free survival', 'overall survival, time to pain progression, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event', 'adverse events', 'incidence of adverse events']","[{'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0009241', 'cui_str': 'Cognition Disorders'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",1509.0,0.629713,"Darolutamide was not associated with a higher incidence of seizures, falls, fractures, cognitive disorder, or hypertension than placebo.
","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Ulys', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Egils', 'Initials': 'E', 'LastName': 'Vjaters', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Polyakov', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Jievaltas', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Luz', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kuss', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kappeler', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Snapir', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Sarapohja', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) - all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Bayer, Berlin (I.K., C.K.); and Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1815671']
2051,31390035,Effect of Telephone-Delivered Collaborative Goal Setting and Behavioral Activation vs Enhanced Usual Care for Depression Among Adults With Uncontrolled Diabetes: A Randomized Clinical Trial.,"Importance
Depression symptoms are present in one-third of patients with diabetes, contributing to significant adverse consequences. Population screening of high-risk patients coupled with telephone delivery of evidence-based therapies for comorbid diabetes may address barriers to care.
Objective
To evaluate the effectiveness of proactive population screening plus telephone delivery of a collaborative goal-setting intervention among high-risk patients with uncontrolled diabetes and depression.
Design, Setting, and Participants
In this randomized clinical trial, 225 participants (intervention [n = 136] and control [n = 89]) were enrolled from a regional Veterans Healthcare System serving Southeast Texas from November 1, 2012, through June 24, 2016. Data were gathered at baseline and 6 and 12 months after intervention. Patients selected had uncontrolled diabetes (hemoglobin A1c [HbA1c] >7.5%]) and clinically significant depression (Patient Health Questionnaire-9 scores [PHQ-9] ≥10) and were living more than 20 miles from the Veterans Affairs medical center. Data collection was completed on December 6, 2016, and final analyses were completed by January 25, 2018. All analyses were intent to treat.
Interventions
Healthy Outcomes Through Patient Empowerment (HOPE) included 9 telephone sessions with 24 trained health care professionals using collaborative goal-setting and behavioral activation methods. The control group received enhanced usual care (EUC) and notification of high-risk status.
Main Outcomes and Measures
Change in depression symptoms using PHQ-9 and glycemic control using HbA1c from baseline to 6 months and to 12 months. Secondary analyses evaluated clinically significant responses for these measures.
Results
Among 225 participants, 202 (89.8%) were men, the mean (SD) age was 61.9 (8.3) years, 145 (64.4%) were married, and 156 (69.3%) had some education beyond high school. For the overall study, 38 participants (16.9%) were lost to follow-up or withdrew at 6 months and another 21 (9.3%) were lost to follow-up or withdrew at 12 months. Repeated-measures analysis with multiple imputation for missing data assessing the interaction of treatment group (HOPE vs EUC) and time (baseline, 6 months, and 12 months) found no significant improvement in PHQ-9 (β, 1.56; 95% CI, -0.68 to 3.81; P = .17) or HbA1c (β, -0.005; 95% CI, -0.73 to 0.72; P = .82). Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P = .03) and for HbA1c of -0.06% (95% CI, -0.61% to 0.50%; P = .83). A secondary analysis of patients experiencing a clinical response found that 52.1% of HOPE participants had clinically significant responses in PHQ-9 at 12 months vs 32.9% in EUC (difference, 0.19; 95% CI, 0.04-0.33; P = .01).
Conclusions and Relevance
Telephone-delivered, collaborative goal setting produced clinically significant reductions in depression symptoms but not glycemic control among patients who remained engaged at 12 months compared with EUC among a population screened sample of high-risk patients with diabetes and depression. Although the intervention created some lasting effect for depression, additional strategies are needed to maintain engagement of this high-risk population within an interprofessional team approach to primary care.
Trial Registration
ClinicalTrials.gov identifier: NCT01572389.",2019,"Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P = .03) and for HbA1c of -0.06% (95% CI, -0.61% to 0.50%; P = .83).","['Healthy Outcomes Through Patient Empowerment (HOPE) included 9 telephone sessions with 24 trained health care professionals using collaborative goal-setting and behavioral activation methods', 'Patients selected had uncontrolled diabetes (hemoglobin A1c', '225 participants (intervention [n\u2009=\u2009136] and control [n\u2009=\u200989]) were enrolled from a regional Veterans Healthcare System serving Southeast Texas from November 1, 2012, through June 24, 2016', 'the mean (SD) age was 61.9 (8.3) years, 145 (64.4%) were married, and 156 (69.3%) had some education beyond high school', 'Adults With Uncontrolled Diabetes', 'high-risk patients with uncontrolled diabetes and depression', '225 participants, 202 (89.8%) were men']","['Telephone-Delivered Collaborative Goal Setting and Behavioral Activation vs Enhanced Usual Care for Depression', 'proactive population screening plus telephone delivery of a collaborative goal-setting intervention', 'EUC', 'enhanced usual care (EUC) and notification of high-risk status']","['depression symptoms', 'depression symptoms using PHQ-9 and glycemic control using HbA1c', 'PHQ-9']","[{'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",225.0,0.255136,"Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P = .03) and for HbA1c of -0.06% (95% CI, -0.61% to 0.50%; P = .83).","[{'ForeName': 'Aanand D', 'Initials': 'AD', 'LastName': 'Naik', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Hundt', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Vaughan', 'Affiliation': 'Alkek Department of Medicine, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Petersen', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'Zeno', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cully', 'Affiliation': 'Research Service Line, Houston Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey VA Medical Center, Houston, Texas.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8634']
2052,31390037,Efficacy of a Technology-Enhanced Community Health Nursing Intervention vs Standard of Care for Female Adolescents and Young Adults With Pelvic Inflammatory Disease: A Randomized Clinical Trial.,"Importance
Pelvic inflammatory disease (PID) is a common reproductive health disorder that disproportionately affects female adolescents and young adults. Despite data indicating poor adherence and adverse outcomes among those who experience subsequent Neisseria gonorrhoeae and Chlamydia trachomatis infection, few trials have been designed to address this public health need.
Objective
To examine the efficacy of a technology-enhanced community health nursing (TECH-N) intervention vs standard of care for improving PID self-management behaviors and 90-day longitudinal prevalence of N gonorrhoeae and C trachomatis infection.
Design, Setting, and Participants
This randomized clinical trial of the TECH-N intervention was conducted among female patients 13 to 25 years of age diagnosed with mild to moderate PID who were being discharged to outpatient treatment from September 6, 2012, to December 8, 2016, at a large academic medical center. The final analysis of data was completed in November 2018. This study compared the efficacy of the intervention with that of the standard of care using an intention-to-treat analysis.
Interventions
Enrolled participants completed an audio computer-assisted self-interview, provided specimens for N gonorrhoeae and C trachomatis testing, and were randomized to standard treatment (n = 137) or the TECH-N intervention (n = 149). Intervention participants received text-messaging support and a community health nurse visit within 5 days of diagnosis. Change in the prevalence of N gonorrhoeae and C trachomatis infection was estimated with logistic regression. The N gonorrhoeae and C trachomatis positivity rate over time was evaluated using generalized estimating equations.
Main Outcomes and Measures
The primary outcome was the prevalence of N gonorrhoeae and C trachomatis infection at 90-day follow-up. The secondary outcome was adherence to the Centers for Disease Control and Prevention recommendations for self-care.
Results
A total of 286 patients (mean [SD] age, 18.8 [2.5] years; 268 [93.7%] African American) participated in the study. Although the study groups were demographically similar, the intervention group had a higher baseline rate of C trachomatis infection (45 of 139 [32.4%] vs 25 of 132 [18.9%], P = .01). Although N gonorrhoeae and C trachomatis positivity was not statistically different between groups at 90-day follow-up (6 of 135 [4.4%] vs 13 of 125 [10.4%], P = .07), the differential rate of decrease was significantly higher in the intervention group (48 of 140 [34.4%] to 6 of 135 [4.4%] compared with 34 of 133 [25.6%] to 13 of 112 [10.4%], P = .02). Intervention participants were more likely to receive the Centers for Disease Control and Prevention-recommended short-term follow-up visit compared with the control group (131 of 139 [94.2%] vs 20 of 123 [16.3%], P < .001).
Conclusions and Relevance
Adolescent and young adults with PID in the TECH-N intervention were more likely to experience decreases in N gonorrhoeae and C trachomatis positivity compared with the control group and to receive short-term clinical assessment. These findings suggest that the TECH-N intervention should be considered as a potential enhancement of standard of care approaches for management of female adolescents and young adults with mild to moderate PID in urban communities facing significant sexually transmitted infection disparities.
Trial Registration
ClinicalTrials.gov identifier: NCT01640379.",2019,"Although N gonorrhoeae and C trachomatis positivity was not statistically different between groups at 90-day follow-up (6 of 135 [4.4%] vs 13 of 125 [10.4%], P = .07), the differential rate of decrease was significantly higher in the intervention group (48 of 140 [34.4%] to 6 of 135 [4.4%] compared with 34 of 133 [25.6%] to 13 of 112 [10.4%], P = .02).","['286 patients (mean [SD] age, 18.8 [2.5] years; 268 [93.7%] African American) participated in the study', 'Female Adolescents and Young Adults With Pelvic Inflammatory Disease', 'female adolescents and young adults', 'female patients 13 to 25 years of age diagnosed with mild to moderate PID who were being discharged to outpatient treatment from September 6, 2012, to December 8, 2016, at a large academic medical center']","['TECH-N intervention', 'text-messaging support and a community health nurse visit', 'Technology-Enhanced Community Health Nursing Intervention vs Standard of Care', 'audio computer-assisted self-interview, provided specimens for N gonorrhoeae and C trachomatis testing', 'technology-enhanced community health nursing (TECH-N) intervention vs standard of care']","['baseline rate of C trachomatis infection', 'prevalence of N gonorrhoeae and C trachomatis infection', 'C trachomatis positivity', 'differential rate of decrease', 'adherence to the Centers for Disease Control and Prevention recommendations for self-care', 'Centers for Disease Control and Prevention-recommended short-term follow-up visit']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0242172', 'cui_str': 'Pelvic Inflammatory Disease'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1522710', 'cui_str': 'Nurses, Community Health'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009471', 'cui_str': 'Community Health Nursing'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]",286.0,0.0756613,"Although N gonorrhoeae and C trachomatis positivity was not statistically different between groups at 90-day follow-up (6 of 135 [4.4%] vs 13 of 125 [10.4%], P = .07), the differential rate of decrease was significantly higher in the intervention group (48 of 140 [34.4%] to 6 of 135 [4.4%] compared with 34 of 133 [25.6%] to 13 of 112 [10.4%], P = .02).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Trent', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'Johns Hopkins International STD Laboratory, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Anders', 'Affiliation': 'Division of Pediatric Emergency Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tabacco Saeed', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rowell', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Huettner', 'Affiliation': 'Section on Adolescent/Young Adult Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rothman', 'Affiliation': 'Department of Adult Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Butz', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8652']
2053,24843324,A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery.,"BACKGROUND
One of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. Its main disadvantage remains the short duration of action. Hence, different additives have been used. Dexmedetomidine is a potent as well as highly selective α2 adrenergic receptor agonist. The aim of this randomized, double-blinded, study was to compare the duration of postoperative analgesia of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing lower abdominal or perineal surgery.
PATIENTS AND METHODS
A total of 50 pediatric patients 1-5 years old The American Society of Anesthesiologists status I, II scheduled for lower abdominal and perineal surgeries were included in the study. The patients were enrolled into 2 equal groups: Group A patients (n = 25) received dexmedetomidine with bupivacaine while Group B patients (n = 25) received morphine with bupivacaine. Patients were placed in a supine position then inhalational general anesthesia was induced, and laryngeal mask airway (LMA) was placed. Patients were then given caudal epidural analgesia. By the end of surgery reversal of muscle relaxation was done and the LMA was removed. Post-operatively, the sedation as well as pain score were observed and recorded.
RESULTS
The current study showed that minor complications were recorded in the post-anesthesia care unit; in addition, significantly longer periods of analgesia and sedation were detected in Group A. However, no significant differences in demographic data, as well as in the duration of surgery, and the time of emergence from anesthesia and patient condition during recovery were detected.
CONCLUSION
The present study suggested that use of dexmedetomidine, during single dose injection, as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of post-operative analgesia following lower abdominal as well as perineal surgery compared with caudal morphine with no side-effects on the vital signs. Postoperative side effects were seen with caudal morphine injection rather than with dexmedetomidine.",2014,"However, no significant differences in demographic data, as well as in the duration of surgery, and the time of emergence from anesthesia and patient condition during recovery were detected.
","['pediatric patients undergoing lower abdominal or perineal surgery', 'pediatric infra-umbilical surgery', '50 pediatric patients 1-5 years old']","['morphine', 'Dexmedetomidine', 'morphine with bupivacaine', 'inhalational general anesthesia was induced, and laryngeal mask airway (LMA', 'dexmedetomidine with bupivacaine', 'caudal morphine', 'caudal epidural analgesia', 'bupivacaine', 'caudal dexmedetomidine', 'dexmedetomidine']","['Postoperative side effects', 'duration of surgery, and the time of emergence from anesthesia and patient condition during recovery', 'pain score', 'analgesia and sedation']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block (procedure)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1301785', 'cui_str': 'Emergence from anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444752', 'cui_str': 'Status during (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",50.0,0.135476,"However, no significant differences in demographic data, as well as in the duration of surgery, and the time of emergence from anesthesia and patient condition during recovery were detected.
","[{'ForeName': 'Hossam A', 'Initials': 'HA', 'LastName': 'El Shamaa', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130677']
2054,24843335,The optimal effect-site concentration of sufentanil for laryngeal mask insertion during induction with target-controlled propofol infusion at 4.0 μg/mL.,"OBJECTIVE
The objective of this study is to determine the optimal effect-site concentration (Ce) of sufentanil for satisfactory insertion of laryngeal mask airway (LMA) when administered with a target-controlled infusion (TCI) of propofol at 4.0 μg/mL.
MATERIALS AND METHODS
A total of 25 adult patients scheduled for minor elective surgery were enrolled in this study. All patients received induction with a combination of propofol and sufentanil TCI. The TCI of sufentanil was started at a target Ce of 0.1 ng/mL. After equilibrium with the plasma concentration, the TCI of propofol was initiated, targeting a preset Ce of 4.0 μg/mL. After the loss of consciousness, LMA was inserted and assessed by an experienced Anesthesiologist. The Ce of sufentanil for the next patient was guided by modified Dixon's up-and-down method using 0.05 ng/mL as a step size. The Ce of sufentanil required for successful LMA insertion in 50% of adults (EC50) was determined by calculating the midpoint concentration of all independent pairs of patients after at least seven crossover points.
RESULTS
The optimal Ce (EC50) of sufentanil for LMA insertion during propofol induction using target Ce of 4 μg/mL was 0.16 ng/mL (95% confidence interval [CI] = 0.12-0.20). There was a significant reduction in propofol induced pain score P = 0.0275 and insignificant hemodynamic changes.
CONCLUSION
Ce of sufentanil required for successful LMA insertion in 50% of patients (EC50) using propofol target Ce of 4.0 μg/mL was 0.16 ng/mL (95% CI = 0.12-0.20) with a significant reduction in the propofol induced pain and hemodynamic stability.",2014,"There was a significant reduction in propofol induced pain score P = 0.0275 and insignificant hemodynamic changes.
",['A total of 25 adult patients scheduled for minor elective surgery were enrolled in this study'],"['propofol', 'sufentanil', 'propofol and sufentanil TCI']","['successful LMA insertion', 'propofol induced pain score', 'pain and hemodynamic stability']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",25.0,0.237292,"There was a significant reduction in propofol induced pain score P = 0.0275 and insignificant hemodynamic changes.
","[{'ForeName': 'Roshdi R', 'Initials': 'RR', 'LastName': 'Al-Metwalli', 'Affiliation': 'Department of Anesthesiology, University of Dammam, King Fahad Hospital, Al-Khobar, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130721']
2055,24843337,Evaluations of topical application of tranexamic acid on post-operative blood loss in off-pump coronary artery bypass surgery.,"OBJECTIVE
One of the major complications of cardiac surgery is the presence of post-operative bleeding. The aim of the present study was to investigate the topical application of tranexamic acid in the pericardial cavity on post-operative bleeding in off-pump coronary artery bypass graft (CABG) surgery.
MATERIALS AND METHODS
This study was on 71 patients who underwent off-pump CABG. The anesthesia and surgery methods were the same for all patients. Patients were assigned to two equal groups. In the first group, 1 g of tranexamic acid in 100 mL of normal saline solution (NSS) was applied to pericardium and mediastinal cavity at the end of surgery. In the second group, only 100 mL of NSS was applied. Chest drainage of the patients after 24 h and the amounts of blood and blood products transfusion were also recorded during this time.
RESULTS
Patients were the same regarding demographic information and surgery. The average volume of blood loss after 24 h was 366 mL for the first group and 788 mL for the control group. There was a statistically significant difference between the two groups (P < 0.001). The amount of packed red blood cells transfusion in the first group was less than that of the control group, which was not statistically significant. There was no statistically significant difference between the amount of hemoglobin, hematocrit, platelets, prothrombin time and partial thromboplastin time in the post-operative stage in the two groups.
CONCLUSION
The topical application of tranexamic acid in off-pump CABG patients leads to a decreased post-operative blood loss.",2014,The topical application of tranexamic acid in off-pump CABG patients leads to a decreased post-operative blood loss.,"['off-pump coronary artery bypass surgery', '71 patients who underwent off-pump CABG']","['normal saline solution (NSS', 'tranexamic acid']","['average volume of blood loss', 'packed red blood cells transfusion', 'blood and blood products transfusion', 'Chest drainage', 'hemoglobin, hematocrit, platelets, prothrombin time and partial thromboplastin time']","[{'cui': 'C1449706', 'cui_str': 'Coronary Artery Bypass, Off-Pump'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199962', 'cui_str': 'Transfusion of packed red blood cells (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}]",,0.0429454,The topical application of tranexamic acid in off-pump CABG patients leads to a decreased post-operative blood loss.,"[{'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Rahimianfar', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Abdollahi', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Moshtaghiyoon', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Haddadzadeh', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Asefeh', 'Initials': 'A', 'LastName': 'Fekri', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Barzegar', 'Affiliation': 'Faculty member at the English Language Department, School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rahimianfar', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130724']
2056,24843327,Oral clonidine versus gabapentin as premedicant for obtunding hemodynamic response to laryngoscopy and tracheal intubation.,"BACKGROUND
We compared the effects of oral clonidine and gabapentin as premedicant in obtunding hemodynamic response to laryngoscopy and intubation in normotensive patients undergoing elective surgery.
METHODS
A total of 100 patients of either sex enrolled in the study were randomly divided into two groups of 50 each. Group A patients received oral clonidine 200 μg and Group B patients received oral gabapentin 900 mg, 90 min prior to induction of anesthesia.
RESULTS
Both groups were matched for age, sex weight and intubation time. Anxiety score and sedation scores before induction were significantly better in Group A as compared with Group B. Heart rate rise was obtunded in Group A except at 1 min, as compared with Group B in which tachycardia persisted even at 3 and 5 min following intubation. Mean arterial pressure was maintained below baseline at all times in Group A as compared with Group B in which significant rise (+7.55%, P < 0.001) was seen at 1 min after intubation.
CONCLUSION
Oral clonidine provided good attenuation of hemodynamic response to laryngoscopy and intubation as compared with oral gabapentin.",2014,"Anxiety score and sedation scores before induction were significantly better in Group A as compared with Group B. Heart rate rise was obtunded in Group A except at 1 min, as compared with Group B in which tachycardia persisted even at 3 and 5 min following intubation.","['normotensive patients undergoing elective surgery', '100 patients of either sex enrolled in the study']","['clonidine and gabapentin', 'gabapentin', 'oral gabapentin', 'oral gabapentin 900 mg, 90 min prior to induction of anesthesia', 'clonidine', 'oral clonidine', 'Oral clonidine']","['Mean arterial pressure', 'hemodynamic response', 'Anxiety score and sedation scores', 'Heart rate rise']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",,0.0272277,"Anxiety score and sedation scores before induction were significantly better in Group A as compared with Group B. Heart rate rise was obtunded in Group A except at 1 min, as compared with Group B in which tachycardia persisted even at 3 and 5 min following intubation.","[{'ForeName': 'Suresh K', 'Initials': 'SK', 'LastName': 'Singhal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Kiranpreet', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Promila', 'Initials': 'P', 'LastName': 'Arora', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130692']
2057,24843328,Effect of slow versus rapid rewarming on jugular bulb oxygen saturation in adult patients undergoing open heart surgery.,"BACKGROUND
A debate has appeared in the recent literature about the optimum rewarming strategy (slow vs. rapid) for the best brain function. This study was designed to compare the effect of slow versus rapid rewarming on jugular bulb oxygen saturation (SjO2) in adult patients undergoing open heart surgery.
MATERIALS AND METHODS
A total of 80 patients undergoing valve and adult congenital heart surgery were randomly allocated equally to rapid rewarming group 0.5 (0.136)°C/min and slow rewarming group 0.219 (0.055)°C/min in jugular bulb sampling was taken before, during and after surgery. Surgery was done at cardiopulmonary bypass (CPB) temperature of 28-30°C and rewarming was performed at the end of the surgical procedure.
RESULTS
CPB time, rewarming period were significantly longer in the slow rewarming group. Significant difference was observed in the number of the desaturated patients (SjO2 ≤ 50%) between the two groups; 14 (35%) in rapid rewarming versus 6 (15%) in the slow rewarming group; P = 0.035 by Fisher's exact test.
CONCLUSIONS
Slow rewarming could reduce the incidence of SjO2 desaturation during rewarming in adult patients undergoing open heart surgery.",2014,"Significant difference was observed in the number of the desaturated patients (SjO2 ≤ 50%) between the two groups; 14 (35%) in rapid rewarming versus 6 (15%) in the slow rewarming group; P = 0.035 by Fisher's exact test.
","['adult patients undergoing open heart surgery', '80 patients undergoing valve and adult congenital heart surgery']","['rapid rewarming group 0.5', 'slow versus rapid rewarming', 'slow versus rapid rewarming on jugular bulb oxygen saturation (SjO2', 'Slow rewarming']","['SjO2 desaturation', 'CPB time, rewarming period', 'jugular bulb oxygen saturation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0206156', 'cui_str': 'Rewarming'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2711336', 'cui_str': 'Jugular bulb oxygen saturation'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0206156', 'cui_str': 'Rewarming'}, {'cui': 'C2711336', 'cui_str': 'Jugular bulb oxygen saturation'}]",80.0,0.0693619,"Significant difference was observed in the number of the desaturated patients (SjO2 ≤ 50%) between the two groups; 14 (35%) in rapid rewarming versus 6 (15%) in the slow rewarming group; P = 0.035 by Fisher's exact test.
","[{'ForeName': 'Mohmaed Shaaban', 'Initials': 'MS', 'LastName': 'Ali', 'Affiliation': 'Departments of Anesthesia, Assiut University Hospital, Assiut, Egypt.'}, {'ForeName': 'Sameh Abd Al Rhman', 'Initials': 'SA', 'LastName': 'Sayed', 'Affiliation': 'Department of Cardiothoracic Surgery Department, Assiut University Hospital, Assiut, Egypt.'}, {'ForeName': 'Maged Salah', 'Initials': 'MS', 'LastName': 'Mohamoud', 'Affiliation': 'Department of Clinical Pathology Department, Assiut University Hospital, Assiut, Egypt.'}, {'ForeName': 'Sayed Kaoud', 'Initials': 'SK', 'LastName': 'Abd-Elshafy', 'Affiliation': 'Departments of Anesthesia Assiut University Hospital, Assiut, Egypt.'}, {'ForeName': 'Mohamed Gomaa', 'Initials': 'MG', 'LastName': 'Almaz', 'Affiliation': 'Departments of Anesthesia Assiut University Hospital, Assiut, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130698']
2058,24843329,A comparison of conventional endotracheal tube with silicone wire-reinforced tracheal tube for intubation through intubating laryngeal mask airway.,"BACKGROUND
A specially designed wire-reinforced endotracheal tube - the Fastrach silicone tube (FTST) designed to facilitate endotracheal intubation through intubating laryngeal mask airway (ILMA) are expensive and not readily available. Hence, it is worth considering alternative such as polyvinyl chloride tracheal tube (PVCT), which is disposable, cheap and easily available. The aim of the present study was to compare the clinical performance of FTST with conventional PVCT for tracheal intubation through ILMA.
METHODS
After informed consent, 60 ASA I-II adults with normal airway undergoing elective surgery were randomly allocated to undergo blind tracheal intubation through ILMA with a FTST or conventional PVCT. Overall success rate, ease of insertion, number of attempts for successful intubation, critical incidence during intubation and post-operative sore throat were compared.
RESULTS
The overall success rate with FTST was 96.63% and 93.33% with PVCT; in addition, the first-attempt success rate was 86.25% with FTST compared to 82.14% with PVCT. The time taken for intubation was 18.6 ± 6.8 s. in FTST group and 22.42 ± 8.5 s. in PVCT group. Incidence of sore throat was 21.42% in PVCT group compared with 6.89% in FTST group.
CONCLUSION
Blind tracheal intubation through an ILMA with the conventional PVCT instead of FTST is a feasible alternative in patients with normal airways.",2014,"Incidence of sore throat was 21.42% in PVCT group compared with 6.89% in FTST group.
","['patients with normal airways', '60 ASA I-II adults with normal airway undergoing elective surgery']","['PVCT', 'ILMA with a FTST or conventional PVCT', 'FTST', 'wire-reinforced endotracheal tube - the Fastrach silicone tube (FTST', 'conventional endotracheal tube with silicone wire-reinforced tracheal tube', 'polyvinyl chloride tracheal tube (PVCT', 'FTST with conventional PVCT']","['overall success rate with FTST', 'time taken for intubation', 'success rate', 'Incidence of sore throat', 'Overall success rate, ease of insertion, number of attempts for successful intubation, critical incidence during intubation and post-operative sore throat']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}, {'cui': 'C0587273', 'cui_str': 'Armored endotracheal tube'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube (physical object)'}, {'cui': 'C0032624', 'cui_str': 'Vinyl Chloride Polymer'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",60.0,0.13638,"Incidence of sore throat was 21.42% in PVCT group compared with 6.89% in FTST group.
","[{'ForeName': 'Veena R', 'Initials': 'VR', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesia and Critical Care, Smt. K.M. Mehta and Smt. G.R. Doshi Institute of Kidney Diseases and Research Center, Dr. H.L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Guruprasad P', 'Initials': 'GP', 'LastName': 'Bhosale', 'Affiliation': 'Department of Anesthesia and Critical Care, Smt. K.M. Mehta and Smt. G.R. Doshi Institute of Kidney Diseases and Research Center, Dr. H.L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Tanu', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': 'Department of Anesthesia and Critical Care, Smt. K.M. Mehta and Smt. G.R. Doshi Institute of Kidney Diseases and Research Center, Dr. H.L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Geeta P', 'Initials': 'GP', 'LastName': 'Parikh', 'Affiliation': 'Department of Anesthesia and Critical Care, Smt. K.M. Mehta and Smt. G.R. Doshi Institute of Kidney Diseases and Research Center, Dr. H.L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130702']
2059,24843330,"A comparison of McCoy, TruView, and Macintosh laryngoscopes for tracheal intubation in patients with immobilized cervical spine.","BACKGROUND
Cervical spine immobilization results in a poor laryngeal view on direct laryngoscopy leading to difficulty in intubation. This randomized prospective study was designed to compare the laryngeal view and ease of intubation with the Macintosh, McCoy, and TruView laryngoscopes in patients with immobilized cervical spine.
MATERIALS AND METHODS
60 adult patients of ASA grade I-II with immobilized cervical spine undergoing elective cervical spine surgery were enrolled. Anesthesia was induced with propofol, fentanyl, and vecuronium and maintained with isoflurane and nitrous oxide in oxygen. The patients were randomly allocated into three groups to achieve tracheal intubation with Macintosh, McCoy, or TruView laryngoscopes. When the best possible view of the glottis was obtained, the Cormack-Lehane laryngoscopy grade and the percentage of glottic opening (POGO) score were assessed. Other measurements included the intubation time, the intubation difficulty score, and the intubation success rate. Hemodynamic parameters and any airway complications were also recorded.
RESULTS
TruView reduced the intubation difficulty score, improved the Cormack and Lehane glottic view, and the POGO score compared with the McCoy and Macintosh laryngoscopes. The first attempt intubation success rate was also high in the TruView laryngoscope group. However, there were no differences in the time required for successful intubation and the overall success rates between the devices tested. No dental injury or hypoxia occurred with either device.
CONCLUSION
The use of a TruView laryngoscope resulted in better glottis visualization, easier tracheal intubation, and higher first attempt success rate as compared to Macintosh and McCoy laryngoscopes in immobilized cervical spine patients.",2014,"RESULTS
TruView reduced the intubation difficulty score, improved the Cormack and Lehane glottic view, and the POGO score compared with the McCoy and Macintosh laryngoscopes.","['immobilized cervical spine patients', '60 adult patients of ASA grade I-II with immobilized cervical spine undergoing elective cervical spine surgery were enrolled', 'patients with immobilized cervical spine']","['tracheal intubation with Macintosh, McCoy, or TruView laryngoscopes', 'McCoy, TruView, and Macintosh laryngoscopes', 'propofol, fentanyl, and vecuronium', 'isoflurane and nitrous oxide in oxygen', 'TruView laryngoscope']","['intubation time, the intubation difficulty score, and the intubation success rate', 'time required for successful intubation and the overall success rates', 'intubation success rate', 'Hemodynamic parameters and any airway complications', 'Cormack and Lehane glottic view, and the POGO score', 'intubation difficulty score', 'dental injury or hypoxia', 'Cormack-Lehane laryngoscopy grade and the percentage of glottic opening (POGO) score', 'glottis visualization, easier tracheal intubation']","[{'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0242531', 'cui_str': 'Vecuronium'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",60.0,0.0351499,"RESULTS
TruView reduced the intubation difficulty score, improved the Cormack and Lehane glottic view, and the POGO score compared with the McCoy and Macintosh laryngoscopes.","[{'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bharti', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Nidhi B', 'Initials': 'NB', 'LastName': 'Panda', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130705']
2060,24843332,Anesthetic effectiveness of topical levobupivacaine 0.75% versus topical proparacaine 0.5% for intravitreal injections.,"BACKGROUND AND PURPOSE
Today no method of topical anesthesia for intravitreal injection administration has been proven to make the patient comfortable yet. We compared the efficacy of topical levobupivacaine 0.75% and proparacaine 0.5% in patients undergoing intravitreal injections.
MATERIALS AND METHODS
A prospective, randomized study comparing two agents for topical anesthesia in intravitreal injections. Ninety-six consecutive patients were enrolled into two groups to receive either topical levobupivacaine 0.75% (n=48) or proparacaine 0.5% (n=48). Patients were asked to score their pain using a visual analog scale (VAS) immediately following the injection. The average of these scores was used as the primary outcome. The surgeon performing the procedure scored his perception of the patients' pain using the Wong-Baker FACES scale.
RESULTS
Mean VAS pain scores for two groups were found to be 44.77 ± 16.42 and 34.18 ± 14.83, respectively. Mean VAS pain score in the proparacaine group was significantly lower than that in the levobupivacaine group (P= 0.003). Mean Wong-Baker FACES scores for the two groups were 1.08 ± 0.49 and 1.10 ± 0.30, respectively. There was no statistically significant difference between levobupivacaine and proparacaine groups (P=0.824).
CONCLUSIONS
Topical proparacaine 0.5% was more effective in preventing pain during intravitreal injections.",2014,"There was no statistically significant difference between levobupivacaine and proparacaine groups (P=0.824).
","['patients undergoing intravitreal injections', 'Ninety-six consecutive patients']","['intravitreal injections', 'topical levobupivacaine', 'topical proparacaine', 'topical anesthesia', 'proparacaine', 'levobupivacaine', 'Topical proparacaine']","['pain', 'Mean VAS pain score', 'Anesthetic effectiveness', 'score their pain using a visual analog scale (VAS', 'Mean Wong-Baker FACES scores', 'Mean VAS pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0072510', 'cui_str': 'proxymetacaine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",96.0,0.0280905,"There was no statistically significant difference between levobupivacaine and proparacaine groups (P=0.824).
","[{'ForeName': 'Nurgül', 'Initials': 'N', 'LastName': 'Ornek', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Kırıkkale University, Kırıkkale, Turkey.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Apan', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Kırıkkale University, Kırıkkale, Turkey.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Ornek', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Kırıkkale University, Kırıkkale, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Günay', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Kırıkkale University, Kırıkkale, Turkey.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130713']
2061,24843333,Effects of intravenous dexmedetomidine on hyperbaric bupivacaine spinal anesthesia: A randomized study.,"BACKGROUND AND OBJECTIVES
The present study was designed to evaluate the effect of intravenous dexmedetomidine on spinal anesthesia with 0.5% of hyperbaric bupivacaine.
MATERIALS AND METHODS
One hundred American Society of Anesthesiologists (ASA) physical status I/II patients undergoing elective surgeries under spinal anesthesia were randomized into two groups of 50 each. Immediately after subarachnoid block with 3 ml of 0.5% hyperbaric bupivacaine, patients in group D received a loading dose of 1 μg/kg of dexmedetomidine intravenously by infusion pump over 10 min followed by a maintenance dose of 0.5 μg/kg/h till the end of surgery, whereas patients in group C received an equivalent quantity of normal saline.
RESULTS
The time taken for regression of motor blockade to modified Bromage scale 0 was significantly prolonged in group D (220.7 ± 16.5 min) compared to group C (131 ± 10.5 min) (P < 0.001). The level of sensory block was higher in group D (T 6.88 ± 1.1) than group C (T 7.66 ± 0.8) (P < 0.001). The duration for two-dermatomal regression of sensory blockade (137.4 ± 10.9 min vs. 102.8 ± 14.8 min) and the duration of sensory block (269.8 ± 20.7 min vs. 169.2 ± 12.1 min) were significantly prolonged in group D compared to group C (P < 0.001). Intraoperative Ramsay sedation scores were higher in group D (4.4 ± 0.7) compared to group C (2 ± 0.1) (P < 0.001). Higher proportion of patients in group D had bradycardia (33% vs. 4%) (P < 0.001), as compared to group C. The 24-h mean analgesic requirement was less and the time to first request for postoperative analgesic was prolonged in group D than in group C (P < 0.001).
CONCLUSION
Intravenous dexmedetomidine significantly prolongs the duration of sensory and motor block of bupivacaine spinal anesthesia. The incidence of bradycardia is significantly higher when intravenous dexmedetomidine is used as an adjuvant to bupivacaine spinal anesthesia. Dexmedetomidine provides excellent intraoperative sedation and postoperative analgesia.",2014,Intravenous dexmedetomidine significantly prolongs the duration of sensory and motor block of bupivacaine spinal anesthesia.,"['hyperbaric bupivacaine spinal anesthesia', 'One hundred American Society of Anesthesiologists (ASA) physical status I/II patients undergoing elective surgeries under spinal anesthesia']","['subarachnoid block with 3 ml of 0.5% hyperbaric bupivacaine', 'hyperbaric bupivacaine', 'Dexmedetomidine', 'bupivacaine', 'equivalent quantity of normal saline', 'dexmedetomidine']","['time to first request for postoperative analgesic', 'Intraoperative Ramsay sedation scores', 'incidence of bradycardia', 'duration of sensory block', '24-h mean analgesic requirement', 'duration of sensory and motor block', 'bradycardia', 'intraoperative sedation and postoperative analgesia', 'level of sensory block']","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",100.0,0.128254,Intravenous dexmedetomidine significantly prolongs the duration of sensory and motor block of bupivacaine spinal anesthesia.,"[{'ForeName': 'Chilkunda N', 'Initials': 'CN', 'LastName': 'Dinesh', 'Affiliation': 'Department of Anesthesiology, M. S. Ramaiah Medical College, Bangalore, Karnataka, India.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Sai Tej', 'Affiliation': 'Department of Anesthesiology, M. S. Ramaiah Medical College, Bangalore, Karnataka, India.'}, {'ForeName': 'Bevinaguddaiah', 'Initials': 'B', 'LastName': 'Yatish', 'Affiliation': 'Department of Anesthesiology, M. S. Ramaiah Medical College, Bangalore, Karnataka, India.'}, {'ForeName': 'Vinayak S', 'Initials': 'VS', 'LastName': 'Pujari', 'Affiliation': 'Department of Anesthesiology, M. S. Ramaiah Medical College, Bangalore, Karnataka, India.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Mohan Kumar', 'Affiliation': 'Department of Anesthesiology, M. S. Ramaiah Medical College, Bangalore, Karnataka, India.'}, {'ForeName': 'Chadalawada V R', 'Initials': 'CV', 'LastName': 'Mohan', 'Affiliation': 'Department of Anesthesiology, M. S. Ramaiah Medical College, Bangalore, Karnataka, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130719']
2062,24843334,Clonidine as an adjuvant to hyperbaric bupivacaine for spinal anesthesia in elderly patients undergoing lower limb orthopedic surgeries.,"BACKGROUND
In elderly patients, use of adjuvant with small doses of local anesthetics is a preferred technique for spinal anesthesia for lower limb surgeries. This study tested the hypothesis that addition of small doses of clonidine augments the spinal block levels produced by hyperbaric bupivacaine in elderly without affecting the side-effects if any of clonidine in these patients.
MATERIALS AND METHODS
This was a prospective, randomized, double-blind study. Above 60 years male patients were allocated to three equal groups. Group C received 9 mg hyperbaric bupivacaine without clonidine while Group C15 and Group C30 received 15 μg and 30 μg clonidine with hyperbaric bupivacaine respectively for spinal anesthesia. Effect of clonidine on sensory block levels was the primary study outcome measure. Motor blockade and hemodynamic parameters were also studied.
RESULTS
A significantly higher median block levels were achieved in Group C15 (P < 0.001) and Group C30 (P = 0.015) than Group C. Highest median sensory block level, the mean times for sensory regression to T12 level and motor block regression were statistically significant between Groups C15 and C and between Groups C30 and C. On comparison of fall in systolic blood pressure trends, there was no significant difference in the clonidine groups as compared with the control group.
CONCLUSIONS
In elderly patients, clonidine when used intrathecally in doses of 15 μg or 30 μg with bupivacaine, significantly potentiated the sensory block levels and duration of analgesia without affecting the trend of systolic blood pressure as compared to bupivacaine alone. Clonidine in doses of 30 μg however facilitated the ascent of sensory level block to unexpectedly higher dermatomes for a longer time.",2014,"A significantly higher median block levels were achieved in Group C15 (P < 0.001) and Group C30 (P = 0.015) than Group C. Highest median sensory block level, the mean times for sensory regression to T12 level and motor block regression were statistically significant between Groups C15 and C and between Groups C30 and C.","['elderly patients undergoing lower limb orthopedic surgeries', 'elderly patients', 'Above 60 years male patients']","['hyperbaric bupivacaine', 'clonidine with hyperbaric bupivacaine', 'bupivacaine', 'clonidine', 'Clonidine', 'hyperbaric bupivacaine without clonidine']","['systolic blood pressure trends', 'sensory block levels', 'systolic blood pressure', 'mean times for sensory regression to T12 level and motor block regression', 'Motor blockade and hemodynamic parameters', 'median block levels', 'median sensory block level', 'sensory block levels and duration of analgesia']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",60.0,0.126489,"A significantly higher median block levels were achieved in Group C15 (P < 0.001) and Group C30 (P = 0.015) than Group C. Highest median sensory block level, the mean times for sensory regression to T12 level and motor block regression were statistically significant between Groups C15 and C and between Groups C30 and C.","[{'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Chopra', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.'}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Mohta', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Sethi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130720']
2063,24843336,The effect of pre-operative administration of gabapentin on post-operative pain relief after herniorrhaphy.,"BACKGROUND
Gabapentin, an anticonvulsant, recently has been suggested as an effective post-operative ""analgesic"" agent. The objective of the present study was to examine the analgesic effectiveness and opioid-sparing effects associated with the use of a single dose of gabapentin as a prophylactic analgesic.
MATERIALS AND METHODS
In a randomized double-blinded clinical trial, 50 American Society of Anesthesiologists I and II patients with an age range of 40-60 years who were the candidate for inguinal herniorrhaphy under spinal anesthesia were randomly assigned to receive 400 mg gabapentin or placebo 2 h prior to surgery. Post-operatively, the pain was assessed on a visual analog scale (VAS) at 2, 4, 12 and 24 h at rest. Morphine 0.05 mg/kg intravenously was used to treat post-operative pain on patient's demand. Total morphine consumption in the first 24 h after surgery was also recorded.
RESULTS
Patients in the gabapentin group had significantly lower VAS scores at the all-time intervals of study than those in the placebo group (P < 0.05). The total morphine consumption in the first 24 h after surgery was also significantly lower in gabapentin group than in the placebo group (0.9 ± 1.23 vs. 1.8 ± 1.5; P = 0.003). There was no significant difference between the first time of analgesic request among the two groups.
CONCLUSION
In conclusion, prophylactic administration of gabapentin decreases pain scores and analgesic consumption in the first 24 h after repair of inguinal hernia.",2014,The total morphine consumption in the first 24 h after surgery was also significantly lower in gabapentin group than in the placebo group (0.9 ± 1.23 vs. 1.8 ± 1.5; P = 0.003).,"['50 American Society of Anesthesiologists I and II patients with an age range of 40-60 years who were the candidate for inguinal herniorrhaphy under spinal anesthesia', 'post-operative pain relief after herniorrhaphy']","['gabapentin', 'placebo', 'Morphine', 'gabapentin or placebo', 'Gabapentin']","['analgesic effectiveness', 'Total morphine consumption', 'total morphine consumption', 'visual analog scale (VAS', 'analgesic request', 'VAS scores', 'pain scores and analgesic consumption']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",50.0,0.560984,The total morphine consumption in the first 24 h after surgery was also significantly lower in gabapentin group than in the placebo group (0.9 ± 1.23 vs. 1.8 ± 1.5; P = 0.003).,"[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mahoori', 'Affiliation': 'Department of Anesthesiology, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Heydar', 'Initials': 'H', 'LastName': 'Noroozinia', 'Affiliation': 'Department of Anesthesiology, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Hasani', 'Affiliation': 'Department of Anesthesiology, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Hosainzadeh', 'Affiliation': 'Imam Khomeini Training Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130722']
2064,24843341,Evaluation of preoperative Strepsils lozenges on incidence of postextubation cough and sore throat in smokers undergoing anesthesia with endotracheal intubation.,"UNLABELLED
Post-operative sore throat (POST) is an undesirable side effect of endotracheal intubation. Pharmacological and non-pharmacological measures have been utilized for minimizing the morbidity caused by POST. We have tested use of Strepsils lozenges in providing efficacy for decreasing POST in smokers presenting for surgery under general anesthesia with endotracheal intubation.
MATERIALS AND METHODS
100 patients, 20-65 years, American Society of Anesthesiologists (ASA) physical status I and II, either sex, history of smoking, posted for elective surgical procedure of more than 1 hour, requiring general anesthesia with endotracheal intubation were included and randomly divided into groups (n = 50) to receive Strepsils (Group A) and sugar candy (Group B). The patients were assessed for cough, sore throat, and hoarseness of voice after extubation, 30 min, 12 hrs, and 24 hrs after extubation.
RESULTS
At extubation no cough was seen in 39 (78%) patients (group A) compared to 23 (46%) patients (Group B), and mild cough in 22% (Group A) and 52% (Group B). Incidence of sore throat at extubation was lower in group A compared to Group B (P = 0.04). At other times of observations (30 min,12 hrs and 24 hrs) there was a significant decrease in incidence of sore throat in Group A compared to Group B (P = 0.000). Hoarseness of voice was not observed in any patient in either group.
CONCLUSIONS
Use of preoperative Strepsils lozenges decreases incidence of POST and maybe utilized as a simple and cost-effective measure for decreasing the symptoms of POST and increasing the satisfaction of patients.",2014,Incidence of sore throat at extubation was lower in group A compared to Group B (P = 0.04).,"['smokers presenting for surgery under general anesthesia with endotracheal intubation', 'smokers undergoing anesthesia with endotracheal intubation', '100 patients, 20-65 years, American Society of Anesthesiologists (ASA) physical status I and II, either sex, history of smoking, posted for elective surgical procedure of more than 1 hour, requiring general anesthesia with endotracheal intubation']","['Strepsils lozenges', 'Strepsils (Group A) and sugar candy', 'preoperative Strepsils lozenges']","['Incidence of sore throat at extubation', 'mild cough', 'cough, sore throat, and hoarseness of voice', 'incidence of postextubation cough and sore throat', 'incidence of sore throat', 'Hoarseness of voice']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0592141', 'cui_str': 'Strepsils'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}]",100.0,0.0283877,Incidence of sore throat at extubation was lower in group A compared to Group B (P = 0.04).,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesia, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Anesthesia, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Jagdish P', 'Initials': 'JP', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesia, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130737']
2065,24843339,"Pain relief after Arthroscopic Knee Surgery: A comparison of intra-articular ropivacaine, fentanyl, and dexmedetomidine: A prospective, double-blinded, randomized controlled study.","BACKGROUND
Postoperative pain is very common distressing symptom after any surgical procedure. Different drugs in different routes have been used for controlling post-arthroscopic pain. No one proved to be ideal. We have compared the analgesic effect of ropivacaine, fentanyl, and dexmedetomidine when administered through the intra-articular route in arthroscopic knee surgery.
MATERIALS AND METHODS
From March 2008 to July 2010, 99 patients undergoing arthroscopic knee surgery were randomly assigned into three groups (A,B,C) in a prospective double-blinded fashion. Group A received 10 ml of 0.75% ropivacaine, where Group B received 50 μg fentanyl, and Group C received 100 μg of dexmedetomidine through the intra-articular route at the end of procedure. Pain assessed using visual analog scale and diclofenac sodium given as rescue analgesia when VAS >4. Time of first analgesia request and total rescue analgesic used in 24 hours were calculated.
RESULTS
Demographic profiles are quite comparable among the groups. Time for requirement of first postoperative rescue analgesia in Group A was 380.61 ± 22.973 min, in Group B was 326.82 ± 17.131 min and in Group C was 244.09 ± 20.096 minutes. Total rescue analgesia requirement was less in Group A (1.394 ± 0.496) compared to Group B (1.758 ± 0.435) and Group C (2.546 ± 0.546). Group A had higher mean VAS score at 6(th) and 24(th) postoperative hours. No side effects found among the groups.
CONCLUSION
Therefore, it suggests that intra-articular ropivacaine gives better postoperative pain relief, with increased time of first analgesic request and decreased need of total postoperative analgesia compared to fentanyl and dexmedetomidine.",2014,Total rescue analgesia requirement was less in Group A (1.394 ± 0.496) compared to Group B (1.758 ± 0.435) and Group C (2.546 ± 0.546).,"['From March 2008 to July 2010, 99 patients undergoing arthroscopic knee surgery', 'after Arthroscopic Knee Surgery']","['10 ml of 0.75% ropivacaine', 'ropivacaine, fentanyl, and dexmedetomidine', 'ropivacaine', 'diclofenac sodium', 'dexmedetomidine']","['Pain relief', 'Total rescue analgesia requirement', 'total postoperative analgesia', 'postoperative pain relief', 'Time of first analgesia request and total rescue analgesic', 'mean VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}]","[{'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",99.0,0.109689,Total rescue analgesia requirement was less in Group A (1.394 ± 0.496) compared to Group B (1.758 ± 0.435) and Group C (2.546 ± 0.546).,"[{'ForeName': 'Mohammed Babrak', 'Initials': 'MB', 'LastName': 'Manuar', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Bimal Kumar', 'Initials': 'BK', 'LastName': 'Hajra', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Soumyadip', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Orthopedics, R.G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Dipankar', 'Initials': 'D', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapobrata', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of R.M.O cum CT, B.I.N, Kolkata, West Bengal, India.'}, {'ForeName': 'Ratul', 'Initials': 'R', 'LastName': 'Kundu', 'Affiliation': 'Department of R.M.O cum CT, B.I.N, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130727']
2066,24843340,The effects of preemptive tramadol and dexmedetomidine on shivering during arthroscopy.,"BACKGROUND
Shivering, the rate of which in regional anesthesia is 39% is an undesired complication seen postoperatively.
AIMS
This study aims to compare the ability of preventing the shivering of preemptive tramadol and dexmedetomidine during the spinal anesthesia (SA).
METHODS
A total of 90 patients with American Society of Anesthesiologists physical status I-II, aged 18-60 years and undergoing elective arthroscopic surgery with SA were divided into three groups randomly. After spinal block, 100 mg tramadol in 100 ml saline was applied in group T- (n = 30) and 0.5 μg/kg dexmedetomidine in 100 ml saline was applied in group D- (n = 30) and 100 ml saline was administered in group P- (n = 30) in 10 min. The hemodynamics, oxygen saturation, tympanic temperature, shivering and sedation scores were evaluated and recorded intraoperatively and 45 min after a postoperative period.
RESULTS
In group T and D, shivering scores were significantly lower when compared with group P in the intraoperative 20(th) min (P = 0.01). Sedation scores in group D were significantly higher than the baseline values (P = 0.03) and values in group T and P (P = 0.04).
CONCLUSIONS
Preemptive tramadol and dexmedetomidine are effective in preventing the shivering under SA. In addition, dexmedetomidine was superior in increasing the level of sedation which is sufficient to prevent the anxiety without any adverse effects.",2014,"Sedation scores in group D were significantly higher than the baseline values (P = 0.03) and values in group T and P (P = 0.04).
","['90 patients with American Society of Anesthesiologists physical status I-II, aged 18-60 years and undergoing elective arthroscopic surgery with SA', 'shivering during arthroscopy']","['tramadol and dexmedetomidine', 'preemptive tramadol and dexmedetomidine', 'tramadol', 'dexmedetomidine']","['Sedation scores', 'shivering scores', 'hemodynamics, oxygen saturation, tympanic temperature, shivering and sedation scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopic Surgical Procedures'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}]",90.0,0.0446638,"Sedation scores in group D were significantly higher than the baseline values (P = 0.03) and values in group T and P (P = 0.04).
","[{'ForeName': 'Semsettin', 'Initials': 'S', 'LastName': 'Bozgeyik', 'Affiliation': 'Anesthesiology and Reanimation, Gaziantep University School of Medicine, Gaziantep/Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Mizrak', 'Affiliation': 'Anesthesiology and Reanimation, Gaziantep University School of Medicine, Gaziantep/Turkey.'}, {'ForeName': 'Ertuğrul', 'Initials': 'E', 'LastName': 'Kılıç', 'Affiliation': 'Anesthesiology and Reanimation, Gaziantep University School of Medicine, Gaziantep/Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Yendi', 'Affiliation': 'Anesthesiology and Reanimation, Gaziantep University School of Medicine, Gaziantep/Turkey.'}, {'ForeName': 'Berna Kaya', 'Initials': 'BK', 'LastName': 'Ugur', 'Affiliation': 'Anesthesiology and Reanimation, Gaziantep University School of Medicine, Gaziantep/Turkey.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130729']
2067,24843325,Addition of dexmedetomidine to bupivacaine in transversus abdominis plane block potentiates post-operative pain relief among abdominal hysterectomy patients: A prospective randomized controlled trial.,"BACKGROUND
Dexmedetomidine is an alpha 2 adrenergic agonist, prolongs analgesia when used in neuraxial and peripheral nerve blocks. We studied the effect of addition of dexmedetomidine to bupivacaine to perform transversus abdominis plane (TAP) block.
MATERIALS AND METHODS
A total of 50 patients scheduled for abdominal hysterectomy were divided into two equal groups in a randomized double-blinded way. Group B patients (n = 25) received TAP block with 20 ml of 0.25% bupivacaine and 2 ml of normal saline while Group BD (n = 25) received 0.5 mcg/kg (2 ml) of dexmedetomidine and 20 ml of 0.25% bupivacaine bilaterally. Time for first analgesic administration, totally used doses of morphine, pain scores, hemodynamic data and side-effects were recorded.
RESULTS
Demographic and operative characteristics were comparable between the two groups. The time for the first analgesic dose was longer in Group BD than Group B (470 vs. 280 min, P < 0.001) and the total doses of used morphine were less among Group BD patients in comparison to those in Group B (19 vs. 29 mg/24 h, P < 0.001). Visual analog scores were significantly lower in Group BD in the first 8 h post-operatively when compared with Group B, both at rest and on coughing (P < 0.001). In Group BD, lower heart rate was noticed 60 min from the induction time and continued for the first 4 h post-operatively (P < 0.001).
CONCLUSIONS
The addition of dexmedetomidine to bupivacaine in TAP block achieves better local anesthesia and provides better pain control post-operatively without any major side-effects.",2014,"Visual analog scores were significantly lower in Group BD in the first 8 h post-operatively when compared with Group B, both at rest and on coughing (P < 0.001).","['abdominal hysterectomy patients', '50 patients scheduled for abdominal hysterectomy']","['TAP block with 20 ml of 0.25% bupivacaine and 2 ml of normal saline while Group BD', 'Dexmedetomidine', 'bupivacaine', 'dexmedetomidine and 20 ml of 0.25% bupivacaine', 'dexmedetomidine']","['lower heart rate', 'morphine, pain scores, hemodynamic data and side-effects', 'Visual analog scores', 'total doses of used morphine']","[{'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",50.0,0.224154,"Visual analog scores were significantly lower in Group BD in the first 8 h post-operatively when compared with Group B, both at rest and on coughing (P < 0.001).","[{'ForeName': 'Waleed A', 'Initials': 'WA', 'LastName': 'Almarakbi', 'Affiliation': 'Department of Anesthesia and Critical Care, King Abdulaziz University, Jeddah, Saudi Arabia ; Department of Anesthesiology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Kaki', 'Affiliation': 'Department of Anesthesia and Critical Care, King Abdulaziz University, Jeddah, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130683']
2068,24843326,Comparison of epidural butorphanol and fentanyl as adjuvants in the lower abdominal surgery: A randomized clinical study.,"BACKGROUND
Epidural opioids acting through the spinal cord receptors improve the quality and duration of analgesia along with dose-sparing effect with the local anesthetics. The present study compared the efficacy and safety profile of epidurally administered butorphanol and fentanyl combined with bupivacaine (B).
MATERIALS AND METHODS
A total of 75 adult patients of either sex of American Society of Anesthesiologist physical status I and II, aged 20-60 years, undergoing lower abdominal under epidural anesthesia were enrolled into the study. Patients were randomly divided into three groups of 25 each: B, bupivacaine and butorphanol (BB) and bupivacaine + fentanyl (BF). B (0.5%) 20 ml was administered epidurally in all the three groups with the addition of 1 mg butorphanol in BB group and 100 μg fentanyl in the BF group. The hemodynamic parameters as well as various block characteristics including onset, completion, level and duration of sensory analgesia as well as onset, completion and regression of motor block were observed and compared. Adverse events and post-operative visual analgesia scale scores were also noted and compared. Data was analyzed using ANOVA with post-hoc significance, Chi-square test and Fisher's exact test. Value of P < 0.05 was considered significant and P < 0.001 as highly significant.
RESULTS
The demographic profile of patients was comparable in all the three groups. Onset and completion of sensory analgesia was earliest in BF group, followed by BB and B group. The duration of analgesia was significantly prolonged in BB group followed by BF as compared with group B. Addition of butorphanol and fentanyl to B had no effect on the time of onset, completion and regression of motor block. No serious cardio-respiratory side effects were observed in any group.
CONCLUSIONS
Butorphanol and fentanyl as epidural adjuvants are equally safe and provide comparable stable hemodynamics, early onset and establishment of sensory anesthesia. Butorphanol provides a significantly prolonged post-operative analgesia.",2014,"The duration of analgesia was significantly prolonged in BB group followed by BF as compared with group B. Addition of butorphanol and fentanyl to B had no effect on the time of onset, completion and regression of motor block.","['75 adult patients of either sex of American Society of Anesthesiologist physical status I and II, aged 20-60 years, undergoing lower abdominal under epidural anesthesia were enrolled into the study', 'lower abdominal surgery']","['bupivacaine and butorphanol (BB) and bupivacaine + fentanyl (BF', 'epidural butorphanol and fentanyl', 'butorphanol and fentanyl combined with bupivacaine (B', 'Butorphanol', 'butorphanol', 'Butorphanol and fentanyl']","['various block characteristics including onset, completion, level and duration of sensory analgesia as well as onset, completion and regression of motor block', 'time of onset, completion and regression of motor block', 'Adverse events and post-operative visual analgesia scale scores', 'serious cardio-respiratory side effects', 'efficacy and safety profile', 'duration of analgesia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0449244', 'cui_str': 'Time of onset (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",75.0,0.0652327,"The duration of analgesia was significantly prolonged in BB group followed by BF as compared with group B. Addition of butorphanol and fentanyl to B had no effect on the time of onset, completion and regression of motor block.","[{'ForeName': 'Jasleen', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Gian Sagar Medical College & Hospital, Ram Nagar, Banur, Punjab, India.'}, {'ForeName': 'Sukhminder Jit Singh', 'Initials': 'SJ', 'LastName': 'Bajwa', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Gian Sagar Medical College & Hospital, Ram Nagar, Banur, Punjab, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130687']
2069,24267010,"Novel design for a phase IIa placebo-controlled, double-blind randomized withdrawal study to evaluate the safety and efficacy of CNV1014802 in patients with trigeminal neuralgia.","BACKGROUND
Trigeminal neuralgia (TN) is a rare severe unilateral facial pain condition. Current guidelines in trigeminal neuralgia management recommend sodium channel blockers--carbamazepine or oxcarbazepine--as the first-line treatment. However, the currently available drugs are often associated with poor tolerability resulting in sub-optimal pain control. CNV1014802 is a novel sodium channel blocker that is being assessed in the treatment of trigeminal neuralgia. Due to the severity of the condition, it is not ethical to conduct a traditional placebo-controlled randomized controlled trial. It is also difficult to use an active control such as carbamazepine, the current gold standard, because of its complex pharmacology and potential for drug interactions.
METHODS/DESIGN
The trial uses a randomized withdrawal design to assess efficacy in this rare condition. There is a 21-day open-label phase followed by a randomized 28-day placebo-controlled phase for responders. Thirty patients will be randomized. The primary outcome measure will be pain relief, but secondary measures of quality of life will be of significant importance given the effect of this condition on activities of daily living. Safety and adverse event endpoints are described.
DISCUSSION
There have been very few well-controlled, randomized, placebo-controlled studies in trigeminal neuralgia, and the majority of drugs have had other primary uses. Due to the severity of the pain, minimizing the time a patient is administered placebo was a key factor in designing this study. This study will not only provide data on the efficacy of CNV1014802 in trigeminal neuralgia, but will also provide information on the effectiveness and acceptability of a novel trial design in trigeminal neuralgia.
TRIAL REGISTRATION
Trial number NCT01540630.",2013,Current guidelines in trigeminal neuralgia management recommend sodium channel blockers--carbamazepine or oxcarbazepine--as the first-line treatment.,"['Thirty patients', 'patients with trigeminal neuralgia']","['carbamazepine', 'sodium channel blockers--carbamazepine', 'CNV1014802', 'placebo']","['safety and efficacy', 'activities of daily living', 'pain relief']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040997', 'cui_str': 'Fothergill Disease'}]","[{'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0037492', 'cui_str': 'Ion Channels, Sodium'}, {'cui': 'C3886322', 'cui_str': 'CNV1014802'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",30.0,0.399666,Current guidelines in trigeminal neuralgia management recommend sodium channel blockers--carbamazepine or oxcarbazepine--as the first-line treatment.,"[{'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Zakrzewska', 'Affiliation': ""Facial pain unit, Division of Diagnostic, Surgical and Medical Sciences, Eastman Dental Hospital, UCLH NHS Foundation Trust/University College London, 256 Gray's Inn Road, WC1X 8LD, London, UK. j.zakrzewska@ucl.ac.uk.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': ''}, {'ForeName': 'Dominik A', 'Initials': 'DA', 'LastName': 'Ettlin', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Obermann', 'Affiliation': ''}, {'ForeName': 'Gerard M P', 'Initials': 'GM', 'LastName': 'Giblin', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Morisset', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tate', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gunn', 'Affiliation': ''}]",Trials,['10.1186/1745-6215-14-402']
2070,32427108,User Experiences of an Internet-Based Stepped-Care Intervention for Individuals With Cancer and Concurrent Symptoms of Anxiety or Depression (the U-CARE AdultCan Trial): Qualitative Study.,"BACKGROUND
The internet-based stepped-care intervention iCAN-DO, used in the multicenter randomized controlled trial AdultCan, was developed for adult patients undergoing treatment for cancer and concurrently experiencing anxiety or depressive symptoms. iCAN-DO aimed to decrease symptoms of anxiety or depression. Step 1 comprises access to a library with psychoeducational material and a peer-support section, as well as the possibility to pose questions to a nurse. Step 2 of the intervention offers treatment consisting of internet-based cognitive behavioral therapy (iCBT) to participants still experiencing anxiety or depression at 1, 4, or 7 months after inclusion.
OBJECTIVE
The study aimed to explore user experiences of delivery, design, and structure of iCAN-DO from the perspective of people with cancer.
METHODS
We studied user experiences by interviewing 15 informants individually: 10 women with breast cancer (67%), 4 men with prostate cancer (27%), and 1 man with colorectal cancer (7%) with a mean age 58.9 years (SD 8.9). The interviews focused on informants' perceptions of ease of use and of system design and structure. Informants had been included in iCAN-DO for at least 7 months. They were purposefully selected based on activity in Step 1, participation in iCBT (ie, Step 2), gender, and diagnosis.
RESULTS
Of the 15 informants, 6 had been offered iCBT (40%). All informants used the internet on a daily basis, but 2 (13%) described themselves as very inexperienced computer users. The analysis revealed three subthemes, concerning how user experiences were affected by disease-specific factors and side effects (User experience in the context of cancer), technical problems (Technical struggles require patience and troubleshooting), and the structure and design of iCAN-DO (Appealing and usable, but rather simple).
CONCLUSIONS
The results indicate that user experiences were affected by informants' life situations, the technical aspects and the design of iCAN-DO, and informants' preferences. The results have generated some developments feasible to launch during the ongoing study, but if iCAN-DO is to be used beyond research interest, a greater level of tailoring of information, features, and design may be needed to improve user experiences. The use of recurrent questionnaires during the treatment period may highlight an individual's health, but also function as a motivator showing improvements over time.",2020,"The results indicate that user experiences were affected by informants' life situations, the technical aspects and the design of iCAN-DO, and informants' preferences.","['user experiences by interviewing 15 informants individually: 10 women with breast cancer (67%), 4 men with prostate cancer (27%), and 1 man with colorectal cancer (7%) with a mean age 58.9 years (SD 8.9', 'adult patients undergoing treatment for cancer and concurrently experiencing anxiety or depressive symptoms', 'Individuals With Cancer and Concurrent Symptoms of Anxiety or Depression', 'people with cancer']","['internet-based cognitive behavioral therapy (iCBT', 'Internet-Based Stepped-Care Intervention']",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],10.0,0.0532678,"The results indicate that user experiences were affected by informants' life situations, the technical aspects and the design of iCAN-DO, and informants' preferences.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Igelström', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hauffman', 'Affiliation': 'Department of Immmunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Alfonsson', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Sjöström', 'Affiliation': 'Department of Informatics and Media, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Cajander', 'Affiliation': 'Department of Information Technology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Department of Immmunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}]",Journal of medical Internet research,['10.2196/16604']
2071,31957648,A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel.,"STUDY OBJECTIVES
The aim of this study was to obtain preliminary data on the efficacy, credibility, and acceptability of Exposure, relaxation, and rescripting therapy for military service members and veterans (ERRT-M) in active duty military personnel with trauma-related nightmares.
METHODS
Forty participants were randomized to either 5 sessions of ERRT-M or 5 weeks of minimal contact control (MCC) followed by ERRT-M. Assessments were completed at baseline, posttreatment/postcontrol, and 1-month follow-up.
RESULTS
Differences between ERRT-M and control were generally medium in size for nightmare frequency (Cohen d = -0.53), nights with nightmares (d = -0.38), nightmare severity (d = -0.60), fear of sleep (d = -0.44), and symptoms of insomnia (d = -0.52), and depression (d = -0.51). In the 38 participants who received ERRT-M, there were statistically significant, medium-sized decreases in nightmare frequency (d = -0.52), nights with nightmares (d = -0.50), nightmare severity (d = -0.55), fear of sleep (d = -0.48), and symptoms of insomnia (d = -0.59), posttraumatic stress disorder (PTSD) (d = -0.58) and depression (d = -0.59) from baseline to 1-month follow-up. Participants generally endorsed medium to high ratings of treatment credibility and expectancy. The treatment dropout rate (17.5%) was comparable to rates observed for similar treatments in civilians.
CONCLUSIONS
ERRT-M produced medium effect-size reductions in nightmares and several secondary outcomes including PTSD, depression, and insomnia. Participants considered ERRT-M to be credible. An adequately powered randomized clinical trial is needed to confirm findings and to compare ERRT-M to an active treatment control.
CLINICAL TRIAL REGISTRATION
Registry: ClinicalTrials.gov; Title: A Pilot Randomized Controlled Trial of Treatment for Trauma-Related Nightmares In Active Duty Military Personnel; Identifier: NCT02506595; URL: https://clinicaltrials.gov/ct2/show/NCT02506595.",2020,"CONCLUSIONS
ERRT-M produced medium effect-size reductions in nightmares and several secondary outcomes including PTSD, depression, and insomnia.","['military service members and veterans (ERRT-M) in active duty military personnel with trauma-related nightmares', 'Forty participants', 'trauma-related nightmares in active duty military personnel', 'Trauma-Related Nightmares']","['ERRT-M or 5 weeks of minimal contact control (MCC) followed by ERRT-M. Assessments were completed at baseline, posttreatment/postcontrol, and 1-month follow-up', 'cognitive behavioral treatment']","['efficacy, credibility, and acceptability of Exposure, relaxation', 'treatment dropout rate', 'nightmare frequency', 'symptoms of insomnia', 'PTSD, depression, and insomnia', 'fear of sleep', 'posttraumatic stress disorder (PTSD', 'nights with nightmares', 'nightmare severity']","[{'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",40.0,0.135922,"CONCLUSIONS
ERRT-M produced medium effect-size reductions in nightmares and several secondary outcomes including PTSD, depression, and insomnia.","[{'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Pruiksma', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, Texas.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Nicholson', 'Affiliation': 'Department of Medicine, Carl R. Darnall Army Medical Center, Fort Hood, Texas.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rodgers', 'Affiliation': 'Department of Medicine, Carl R. Darnall Army Medical Center, Fort Hood, Texas.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Hall-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Fina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Cobos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Wardle-Pinkston', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, Texas.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8116']
2072,31870132,Anlotinib Combined with S-1 in the Third-Line Treatment of Stage IV Non-Small Cell Lung Cancer: Study Protocol for Phase II Clinical Trial.,"BACKGROUND
A proportion of patients with stage IV non-small-cell lung cancer (NSCLC) is predicted to receive third-line treatment. However, currently no standard third-line treatment for NSCLC is available. Anlotinib is an oral, multi-targeted tyrosine kinase (TK) receptor inhibitor, which was approved as a third-line treatment for stage IV NSCLC in China on May 9, 2018. Nevertheless, The objective response rate of patients treated with anlotinib was merely 9.2% and the overall survival was only 3 months compared with the patients treated with placebo. Previous studies have shown that cancer treatment with a combination of chemotherapy with TK receptor inhibitors is effective and safe well tolerated. Therefore, the combination of anlotinib with other chemotherapeutic agents may be an effective treatment strategy for patients with stage IV NSCLC. Oral S-1 is a third-generation fluorouracil derivative; it showed good efficacy and caused relatively low toxicity in patients with NSCLC.
METHODS
The purpose of this trial is to evaluate the efficacy and safety of anlotinib combined with S-1 as the third-line treatment for patients with stage IV NSCLC. This is a prospective, phase II clinical trial. We will enroll29 patients with stage IV NSCLC treated with anlotinib plus S-1. Tumors will be assessed using computed tomography prior to treatment, after two, four, and six cycles of treatment, and during follow-up every 3 months until disease progression or death. The primary endpoint is the objective response rate (ORR). The secondary endpoints are progression-free survival, duration of response, proportion of disease control, and safety.
DISCUSSION
The expected outcome of this study is that anlotinib combined with S-1 has tolerable toxicity and better ORR than anlotinibmonotherapy. The results may indicate additional treatment options for patients with stage IV NSCLC.
.",2019,"Nevertheless, The objective response rate of patients treated with anlotinib was merely 9.2% and the overall survival was only 3 months compared with the patients treated with placebo.","['patients with NSCLC', 'patients with stage IV NSCLC', 'patients with stage IV non-small-cell lung cancer (NSCLC', 'patients with stage IV', 'enroll29 patients with stage IV NSCLC treated with', 'Stage IV Non-Small Cell Lung Cancer']","['NSCLC.
50 Kg/m(2)) undergoing laparoscopic sleeve gastrectomies were recruited and provided an informed signed consent. Patients were randomized using a computer generated randomization table to receive either opioid or non-opioid based anesthesia. The patient and the investigator scoring patient outcome after surgery were blinded to the anesthetic protocol. Primary outcomes were hemodynamics in the form of ""heart rate, systolic, diastolic, and mean arterial blood pressure"" on induction and ½ hourly thereafter. Pain monitoring through visual analog scale (VAS) 30 min after recovery, hourly for 2 h and every 4 h for 24 h was also recorded. Pain monitoring through VAS and post-operative nausea and vomiting 30 min after recovery were also recorded and finally patient satisfaction and acute pain nurse satisfaction.
RESULTS
There was no difference in background characteristics in both groups. There were no statistically significant differences in different outcomes as heart rate, mean blood pressure, O2 saturation in different timings between groups at any of the determined eight time points but pain score and nurse satisfaction showed a trend to better performance with non-opioid treatment.
CONCLUSION
Nonopioid based general anesthesia for Bariatric surgery is as effective as opioid one. There is no need to use opioids for such surgery especially that there was a trend to less pain in non-opioid anesthesia.",2013,"There were no statistically significant differences in different outcomes as heart rate, mean blood pressure, O2 saturation in different timings between groups at any of the determined eight time points but pain score and nurse satisfaction showed a trend to better performance with non-opioid treatment.
","['Obese patients (body mass index >50 Kg/m(2)) undergoing', 'bariatric surgery']","['Nonopioid versus opioid based general anesthesia technique', 'opioid or non-opioid based anesthesia', 'laparoscopic sleeve gastrectomies']","['pain', 'pain score and nurse satisfaction', 'efficacy and safety', 'Pain monitoring through visual analog scale (VAS', 'hemodynamics in the form of ""heart rate, systolic, diastolic, and mean arterial blood pressure"" on induction and ½ hourly thereafter', 'heart rate, mean blood pressure, O2 saturation']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",,0.307141,"There were no statistically significant differences in different outcomes as heart rate, mean blood pressure, O2 saturation in different timings between groups at any of the determined eight time points but pain score and nurse satisfaction showed a trend to better performance with non-opioid treatment.
","[{'ForeName': 'Mohamed Ahmed', 'Initials': 'MA', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Ahmed Abdelaal Ahmed', 'Initials': 'AA', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Anesthesia, Beni Suef University, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Geddawy', 'Affiliation': 'King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.121045']
2076,24348289,The effect of ketamine versus fentanyl on the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients undergoing tonsillectomy with or without adenoidectomy.,"BACKGROUND
Emergence agitation (EA) has been documented as a common side-effect of sevoflurane anesthesia. This prospective, randomized, double-blind, placebo-controlled study was designed to compare the effects of ketamine versus fentanyl, administered 10 min before the end of surgery on the development of EA.
METHODS
A total of 120 children aged 3-7 years of American Society of Anesthesiologists I-II physical status were randomly assigned to one of three equal groups receiving either ketamine 0.5 mg/kg (Group K), fentanyl 1 μg/kg (Group F) or saline (Group C) at 10 min before the end of surgery. Post-operative EA was assessed with Aono's four point scale. Recovery times, the post-operative pain and adverse reactions were assessed.
RESULTS
There was no significant difference between the three groups regarding recovery and discharge times from post-anesthesia care unit. The incidence of EA was significantly low in Group K and Group F (15% and 17.5%, respectively) compared to the control group (42.5%), with no significant difference between Group K and Group F. There were no significant differences in Children's Hospital of Eastern Ontario Pain Scale between the three groups. The incidence of nausea or vomiting was significantly more in Group F compared to that in other two groups. However, no complications such as somnolence, oxygen desaturation or respiratory depression occurred during the study period and there were no episodes of hallucinations or bad dreams in the ketamine group.
CONCLUSION
The intravenous administration of either ketamine 0.5 mg/kg or fentanyl 1 μg/kg before the end of surgery in sevoflurane-anesthetized children undergoing tonsillectomy with or without adenoidectomy reduces the incidence of post-operative agitation without delaying emergence.",2013,"The incidence of EA was significantly low in Group K and Group F (15% and 17.5%, respectively) compared to the control group (42.5%), with no significant difference between Group K and Group F.","['pediatric patients undergoing tonsillectomy with or without adenoidectomy', '120 children aged 3-7 years of American Society of Anesthesiologists I-II physical status']","['placebo', 'ketamine 0.5 mg/kg or fentanyl', 'ketamine versus fentanyl', 'fentanyl', 'ketamine', 'sevoflurane-anesthetized children undergoing tonsillectomy with or without adenoidectomy', 'sevoflurane anesthesia', 'ketamine 0.5 mg/kg (Group K), fentanyl 1 μg/kg (Group F) or saline']","['somnolence, oxygen desaturation or respiratory depression', 'incidence of EA', 'nausea or vomiting', 'recovery and discharge times', 'hallucinations or bad dreams', ""Children's Hospital of Eastern Ontario Pain Scale"", 'Recovery times, the post-operative pain and adverse reactions']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0441845', 'cui_str': 'Group K (qualifier value)'}, {'cui': 'C0441840', 'cui_str': 'Group F (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0857051', 'cui_str': 'Bad dreams'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",120.0,0.261997,"The incidence of EA was significantly low in Group K and Group F (15% and 17.5%, respectively) compared to the control group (42.5%), with no significant difference between Group K and Group F.","[{'ForeName': 'Ashraf Arafat', 'Initials': 'AA', 'LastName': 'Abdelhalim', 'Affiliation': 'Department of Anesthesia, Alexandria University, Egypt ; Department of Anesthesia, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Alarfaj', 'Affiliation': 'Department of ENT, King Abdul Aziz University Hospital, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.121047']
2077,24398192,Bladeless direct optical trocar insertion in laparoscopic procedures on the obese patient.,"BACKGROUND
Recently, we have shown advantages of a direct optical entry (DOE) using a bladeless trocar in comparison with the open Hasson technique (OHT) in older reproductive-age women with previous operations, as well as in comparison with Veress needle entry in reproductive-age and postmenopausal women.
OBJECTIVES
A prospective multicenter randomized study to determine whether the DOE is feasible for establishing safe and rapid entry into the abdomen in comparison with those of the OHT in reproductive-age obese women.
METHODS
Two types of surgical techniques were blindly applied in 224 obese reproductive-age women with benign neoplastic diseases of ovary and uterus. Namely, laparoscopic entry into the abdomen in 108 patients was performed by DOE and in 116 women by OHT. Following parameters (entry time in seconds needed to establish the intra-abdominal vision after pneumoperitoneum, blood loss, occurrence of vascular and/or bowel injuries) were compared during surgery as main outcomes.
RESULTS
Main baseline characteristics of patients, including age (36.1 ± 4.5 vs 35.7 ± 5.8), body mass index (34.9 ± 5.1 vs 35.1 ± 4.9 kg/m(2)), and parity (2.1 ± 0.4 vs 1.9 ± 0.9), were not significantly different between the DOE and OHT groups (P > .05). While intraoperative parameters such as the entry time (71.9 ± 3.7 vs 215.1 ± 6.2 seconds) and blood loss value (9.7 ± 6.1 vs 12.2 ± 2.9 mL) were significantly reduced in the DOE group in comparison with those of OHT group (respectively, P < .0001 and < .01), there were also trends to slight decrease of the occurrence of the minor injuries, manifested as omental small vessels rupture (0 of 108 vs 4 of 116) and punctures and pinches of jejunal serosa (0 of 108 vs 3 of 116) in patients of the DOE group in comparison with those of OHT group (respectively, P = .0515 and = .0925).
CONCLUSIONS
DOE reduced entry time and blood loss with trends to slightly decrease of the occurrence of the minor vascular and bowel injuries, thus enabling a possible alternative to OHT in obese women; however, further larger trials need to confirm the possible additional benefits of a DOE.",2013,"CONCLUSIONS
DOE reduced entry time and blood loss with trends to slightly decrease of the occurrence of the minor vascular and bowel injuries, thus enabling a possible alternative to OHT in obese women; however, further larger trials need to confirm the possible additional benefits of a DOE.","['reproductive-age obese women', 'obese women', '108 patients was performed by DOE and in 116 women by OHT', 'obese patient', '224 obese reproductive-age women with benign neoplastic diseases of ovary and uterus', 'older reproductive-age women with previous operations']","['Bladeless direct optical trocar insertion', 'DOE', 'OHT', 'direct optical entry (DOE) using a bladeless trocar in comparison with the open Hasson technique (OHT']","['blood loss, occurrence of vascular and/or bowel injuries', 'blood loss value', 'omental small vessels rupture', 'entry time and blood loss', 'punctures and pinches of jejunal serosa', 'body mass index']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0086692', 'cui_str': 'Benign Neoplasm'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028977', 'cui_str': 'Omentum'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0022378', 'cui_str': 'Jejunum'}, {'cui': 'C0036760', 'cui_str': 'Serosa'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",224.0,0.159441,"CONCLUSIONS
DOE reduced entry time and blood loss with trends to slightly decrease of the occurrence of the minor vascular and bowel injuries, thus enabling a possible alternative to OHT in obese women; however, further larger trials need to confirm the possible additional benefits of a DOE.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tinelli', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Experimental Endoscopic Surgery, Imaging, Technology and Minimally Invasive Therapy, Vito Fazzi Hospital, Piazza Muratore, 73100 Lecce, Italy. andreatinelli@gmail.com.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Malvasi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Santa Maria Hospital, Bari, Italy.'}, {'ForeName': 'Ospan A', 'Initials': 'OA', 'LastName': 'Mynbaev', 'Affiliation': 'Experimental Researches and Modeling Division, Moscow State University of Medicine and Dentistry, Moscow, Russia.'}, {'ForeName': 'Daniel Alberto', 'Initials': 'DA', 'LastName': 'Tsin', 'Affiliation': 'Department of Gynecology, Division of Minimal Invasive Endoscopy, The Mount Sinai Hospital of Queens, New York, NY, USA.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Davila', 'Affiliation': 'Hospital Regional de Poza Rica, Sesver, Monterrey, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Dominguez', 'Affiliation': 'Fundaciòn Hospitalaria, Buenos Aires, Argentina.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Perrone', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Farr R', 'Initials': 'FR', 'LastName': 'Nezhat', 'Affiliation': ""Columbia University College of Physicians and Surgeons, New York, NY, USA, Division of Gynecologic Oncology and the Department of Obstetrics and Gynecology, St. Luke's-Roosevelt Hospital Center, New York, NY, USA.""}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680813X13693422519398']
2078,24398197,Suture versus tack fixation of mesh in laparoscopic umbilical hernia repair.,"BACKGROUND AND OBJECTIVES
Mesh fixation in laparoscopic umbilical hernia repair is poorly studied. We compared postoperative outcomes of laparoscopic umbilical hernia repair in suture versus tack mesh fixation.
METHODS
Patients who underwent laparoscopic umbilical hernia repair were separated by method of mesh fixation: sutures versus primarily tacks. Medical history and follow-up data were collected through medical records. The primary outcome of this study was the recurrence rates of hernias. Postoperative major and minor complications, such as surgical site infection, small-bowel obstruction, and seroma formation, were regarded as secondary outcomes. Additionally, a telephone interview was conducted to assess postoperative pain, recovery time, and overall patient satisfaction.
RESULTS
Eighty-six patients were identified: 33 in the suture group and 53 in the tacks group. The number of emergent cases was increased in the tacks group (6 vs 0; P = .022). Mean follow-up time was 2.7 years for both groups. Documented postoperative follow-up was obtained in 29 (90%) suture group and 31 (58%) tacks group patients. Hernia recurrence occurred in 3 and 2 patients in the sutures and tacks groups, respectively (P was not significant). No differences were found in secondary outcomes, including subjective outcomes from telephone interviews, between groups.
CONCLUSIONS
There are no differences in postoperative complication rates in suture versus tack mesh fixation in laparoscopic umbilical hernia repair.",2013,"Hernia recurrence occurred in 3 and 2 patients in the sutures and tacks groups, respectively (P was not significant).","['Patients who underwent', 'laparoscopic umbilical hernia repair', 'Eighty-six patients were identified: 33 in the suture group and 53 in the tacks group']","['suture versus tack mesh fixation', 'laparoscopic umbilical hernia repair were separated by method of mesh fixation: sutures versus primarily tacks', 'Suture versus tack fixation of mesh', 'laparoscopic umbilical hernia repair in suture versus tack mesh fixation']","['Postoperative major and minor complications, such as surgical site infection, small-bowel obstruction, and seroma formation', 'Hernia recurrence', 'subjective outcomes', 'postoperative complication rates', 'postoperative pain, recovery time, and overall patient satisfaction', 'recurrence rates of hernias', 'number of emergent cases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019333', 'cui_str': 'Repair of umbilical hernia (procedure)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3874006', 'cui_str': 'Tack'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C3874006', 'cui_str': 'Tack'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0019333', 'cui_str': 'Repair of umbilical hernia (procedure)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction (disorder)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",86.0,0.191225,"Hernia recurrence occurred in 3 and 2 patients in the sutures and tacks groups, respectively (P was not significant).","[{'ForeName': 'Riley K', 'Initials': 'RK', 'LastName': 'Kitamura', 'Affiliation': 'Department of Surgery, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lynn', 'Affiliation': 'Department of Surgery, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Celia M', 'Initials': 'CM', 'LastName': 'Divino', 'Affiliation': 'Department of Surgery, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1259, 5th Floor, New York, NY 10029. Celia.Divino@mountsinai.org.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680813X13693422520044']
2079,24348291,Comparison of unilateral spinal and continous spinal anesthesia for hip surgery in elderly patients.,"BACKGROUND
Continous spinal anesthesia (CSA) and frequently unilateral spinal anesthesia (USpA) are usually preferred for lower extremity surgeries. In this study, we aimed to compare the effects of these anesthetic techniques, on hemodynamic parameters, quality of anesthesia and complications in elderly patients undergoing hip surgeries.
METHODS
Forty patients aged 65 years and older, assigned to receive either CSA or USpA with 7.5 mg (1.5 cc) 0.5% hyperbaric bupivacaine initially. In CSA group, additional doses of 2.5 mg bupivacaine were applied until sensory block reach to T10. Maximum sensorial block level, time to reach the level of T10 (defined as onset time) and to regress to T12, hemodynamic parameters and ephedrine requirements were recorded peroperatively and during 2 h postoperatively.
RESULTS
Hemodynamic parameters, ephedrine requirements and regression of sensory block by two levels were similar in two groups. The onset time of anesthesia was significantly longer in USpA group than CSA group. Neuraxial anesthesia had to be converted to general anesthesia in 5 patients (25%) in CSA group and 1 patient (5%) in USpA group.
CONCLUSIONS
We conclude that both USpA and CSA techniques have similar effects in elderly high risk patients. On the other hand, USpA is more preferable for surgeries with shorter durations due to its low cost and high success rate.",2013,The onset time of anesthesia was significantly longer in USpA group than CSA group.,"['with 7.5 mg (1.5 cc', 'elderly patients undergoing hip surgeries', 'Forty patients aged 65 years and older', 'elderly high risk patients', 'elderly patients']","['unilateral spinal and continous spinal anesthesia', 'hyperbaric bupivacaine', 'CSA or USpA', 'bupivacaine', 'Continous spinal anesthesia (CSA) and frequently unilateral spinal anesthesia (USpA', 'USpA and CSA techniques', 'USpA', 'Neuraxial anesthesia']","['onset time of anesthesia', 'Hemodynamic parameters, ephedrine requirements and regression of sensory block', 'Maximum sensorial block level, time to reach the level of T10 (defined as onset time) and to regress to T12, hemodynamic parameters and ephedrine requirements', 'hemodynamic parameters, quality of anesthesia and complications']","[{'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",40.0,0.0254978,The onset time of anesthesia was significantly longer in USpA group than CSA group.,"[{'ForeName': 'Leyla T', 'Initials': 'LT', 'LastName': 'Kilinc', 'Affiliation': 'Department of Anesthesiology and Reanimation, Sisli Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'G Ulufer', 'Initials': 'GU', 'LastName': 'Sivrikaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, Antalya Training and Research Hospital, Antalya, Turkey.'}, {'ForeName': 'Birsen', 'Initials': 'B', 'LastName': 'Eksioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Sisli Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Hanci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Sisli Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Dobrucali', 'Affiliation': 'Department of Anesthesiology and Reanimation, Sisli Etfal Training and Research Hospital, Istanbul, Turkey.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.121054']
2080,24348293,Analyzing the effects of intra-operation video-clip display on hemodynamic and satisfaction of patients during lumbar discectomy under spinal anesthesia.,"OBJECTIVE
Most neurosurgeons and anesthesiologists prefer the less invasive intervention for most surgeries; recently, the lumbar anesthesia is more popular method. In this study we have tried to distract the attention of the patients to their favorite video-clip instead of their surrounding operating room background to evaluate the hemodynamic as well as their satisfaction during the operation.
METHODS
80 patients who were scheduled for an elective one level discectomy under the regional spinal anesthesia enrolled in this prospective randomized clinical trial. The patients were randomized with sealed envelope method and each envelope was randomly assigned from this set of envelops to be either in case group one (video group) or control groups two (no audio and video and only head phone on their ears) group. In all patients, systolic and diastolic blood pressure, pulse rate and SPO2 were measured and recorded in the questionnaire charts.
RESULTS
Of the 80 patients with Lumbar disk herniation, 53 patients were male and 27 female. The mean age for all patients was 44 year. Systolic and diastolic blood pressure at the end of surgery was significantly lower in video group (P=0.045 and 0.004). Systolic Blood pressure differences between 3(rd) and 5(th) and the end of the surgery with minute zero was significantly less in the video group. (P=0.025, 0.018 and 0.030). Diastolic blood pressure differences between 3(rd) and 5(th) and the end of the surgery with minute zero was significantly less in the video group.(P=0.051, 0.019 and 0.15). Pulse rate differences between first, 3(rd), 5(th) and exactly before leaving the recovery room with minute zero was significantly less in the video group. (P=0.015, 0.028, 0.030 and 0.008).
CONCLUSION
According to our study, by displaying patient's favorite video clip during the surgical intervention we could highly reduce the patient's attention to what is happening in operating room and therefore, decrease their anxiety and stress.",2013,Systolic and diastolic blood pressure at the end of surgery was significantly lower in video group (P=0.045 and 0.004).,"['patients during lumbar discectomy under spinal anesthesia', '80 patients who were scheduled for an elective one level discectomy under the regional spinal anesthesia enrolled', '80 patients with Lumbar disk herniation', '53 patients were male and 27 female']","['intra-operation video-clip display', 'control groups two (no audio and video and only head phone on their ears) group']","['hemodynamic and satisfaction', 'Diastolic blood pressure differences', 'systolic and diastolic blood pressure, pulse rate and SPO2', 'Systolic and diastolic blood pressure', 'Systolic Blood pressure differences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",80.0,0.0463126,Systolic and diastolic blood pressure at the end of surgery was significantly lower in video group (P=0.045 and 0.004).,"[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Masoudifar', 'Affiliation': 'Department of Anesthesiology, Kashani Hospital, Isfahan, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Abrishamkar', 'Affiliation': 'Department of Neurosurgery, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Rouhani', 'Affiliation': 'Department of Anesthesiology, Kashani Hospital, Isfahan, Iran.'}, {'ForeName': 'Salman Abbasi', 'Initials': 'SA', 'LastName': 'Fard', 'Affiliation': 'Department of Neurosurgery, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Noorian', 'Affiliation': 'Department of Neurosurgery, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.121058']
2081,24348295,Comparative evaluation of two doses of tranexamic acid used prophylactically in anemic parturients for lower segment cesarean section: A double-blind randomized case control prospective trial.,"BACKGROUND
Postpartum hemorrhage (PPH) and anemia thereafter can be a life threatening condition in parturients undergoing lower segment cesarean section (LSCS), especially when anemia is present.
AIM
The objective of this study was to assess two doses of Tranexamic acid (TXA) in reducing intra operative blood loss and incidence of PPH, in terms of both efficacy and safety profiles, when used prophylactically.
METHODS
A monocenter prospective case control double blind randomized study was carried out on a consecutive series of 90 anemic patients undergoing LSCS, with hemoglobin between 7-10 g percent. Three random groups were formed. Group T1 (n=30) received 10mg/kg TXA in 20 ml of 5% dextrose intravenously, while T2 group (n=30) received 15mg/kg. Group C (n=30) received a placebo. Drug was administered prophylactically 20 min before skin incision. Blood loss was measured from placental delivery up to 24 hours by method of weight and volume.
STAISTICAL ANALYSIS
To compare quantitative data between two groups, t-test, and for more than two groups ANOVA was used. To compare the mean for non- parametric data between two groups Mann - Whitney test was used, while in case of more than two groups Kruskal - Wallis test was employed. Probability (p) value was considered significant when it was 0.05 or less.
RESULTS
TXA significantly reduced blood loss in both the study groups. Mean total blood loss was 527.17±88.666 ml, 376.83±31.961ml and 261.17±56.777 ml in group C, T1, and T2 respectively. While reduction of blood loss in T1 group compared to control group was 146.34±56.32ml, it was 262±31.51ml in T2 group. Difference between T1 and T2 was 115.66±24.81ml, which was statistically significant (P<0.05). Postoperative blood loss was insignificant in all three groups. Pre- and post-operative hemoglobin levels differed significantly when compared to control group. Blood transfusion was needed in two patients in the control group, whereas no patient in groups T1 and T2 needed transfusion (P=0.02). No significant adverse effect was seen in all the three groups.
CONCLUSION
Hence, TXA was found to be effective in reducing blood loss and transfusion in anemic parturients undergoing LSCS. 15mg/kg dose of TXA was more efficacious than the 10mg/kg dose and without any undue increase in adverse events. Postpartum anemia is a public health problem worldwide and TXA could prove to be a very useful drug to prevent blood loss and transfusions in patients undergoing LSCS, especially in the anemic subgroup.",2013,"Blood transfusion was needed in two patients in the control group, whereas no patient in groups T1 and T2 needed transfusion (P=0.02).","['parturients undergoing lower segment cesarean section (LSCS', '90 anemic patients undergoing LSCS, with hemoglobin between 7-10 g percent', 'anemic parturients undergoing LSCS', 'anemic parturients for lower segment cesarean section']","['Tranexamic acid (TXA', '10mg/kg TXA', 'placebo', 'tranexamic acid', 'TXA']","['Blood transfusion', 'Pre- and post-operative hemoglobin levels', 'blood loss', 'intra operative blood loss and incidence of PPH', 'Blood loss', 'blood loss and transfusion', 'Postoperative blood loss', 'adverse events', 'Mean total blood loss', 'adverse effect', 'Probability (p) value']","[{'cui': 'C0195620', 'cui_str': 'Low cervical cesarean section (procedure)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",90.0,0.0790247,"Blood transfusion was needed in two patients in the control group, whereas no patient in groups T1 and T2 needed transfusion (P=0.02).","[{'ForeName': 'Upasana', 'Initials': 'U', 'LastName': 'Goswami', 'Affiliation': 'Department of Anesthesiology, Deen Dayal Upadhyay Hospital, New Delhi, India.'}, {'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Sarangi', 'Affiliation': 'Department of Anesthesiology, Deen Dayal Upadhyay Hospital, New Delhi, India.'}, {'ForeName': 'Sunali', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Deen Dayal Upadhyay Hospital, New Delhi, India.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Babbar', 'Affiliation': 'Department of Anesthesiology, Deen Dayal Upadhyay Hospital, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.121077']
2082,24348297,Use of extraglottic airways in patients undergoing ambulatory laparoscopic surgery without the need for tracheal intubation.,"BACKGROUND
Second generation extraglottic airway devices with gastric access and separate breathing channels have ushered in a new era where their use is increasingly prevalent in surgical patients who would have been traditionally intubated for general anesthesia. New innovations like the i-gel, which is constructed of a thermoplastic elastomer, provide an airtight seal around patient's perilaryngeal anatomy without the inflatable cuff mechanism found in the laryngeal mask airway supreme (LMAS).
METHODS
We conducted a randomized controlled trial comparing the LMAS with the i-gel in 70 anesthetized paralyzed patients undergoing laparoscopic female sterilization. Our primary outcome measure was the oropharyngeal leak pressure (OLP). We studied secondary outcomes of successful first attempt insertion rates, time and ease of the airway and gastric tube insertion, leak fractions and pharyngeal morbidity.
RESULTS
We found no difference in the OLP between LMAS and i-gel, 25.9 (4.2) versus 24.4 (4.3) s, P=0.153. Both devices had similar first attempt insertion rates (LMAS 94% vs. i-gel 91%) with similar ease and comparable times to achieve an effective airway, LMAS 14.7 (2.7) versus i-gel 16.5 (9.6) s, P=0.306, although gastric tube insertion was easier and faster for the LMAS, 7.9 (1.9) versus i-gel 14.8 (7.7) s, P<0.005. Intraoperatively, there was a significantly greater leak fraction with the i-gel of 0.06 (0.03) versus 0.04 (0.02) with the LMAS, P=0.013. Three patients (8.6%) with LMAS had mild sore throat; one patient (2.9%) had mucosal injury. No complications were documented in the i-gel group.
CONCLUSIONS
Both these extraglottic airway devices offer similar OLPs, high insertion success rates at the first attempt with similar ease and insertion times (albeit longer gastric tube insertion with i-gel). Both provided effective ventilation despite a higher leak fraction with i-gel that was clinically inconsequential.",2013,"Intraoperatively, there was a significantly greater leak fraction with the i-gel of 0.06 (0.03) versus 0.04 (0.02) with the LMAS, P=0.013.","['70 anesthetized paralyzed patients undergoing laparoscopic female sterilization', 'surgical patients who would have been traditionally intubated for general anesthesia', 'patients undergoing ambulatory laparoscopic surgery without the need for tracheal intubation']",['LMAS'],"['OLP', 'successful first attempt insertion rates, time and ease of the airway and gastric tube insertion, leak fractions and pharyngeal morbidity', 'oropharyngeal leak pressure (OLP', 'mild sore throat', 'leak fraction']","[{'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404183', 'cui_str': 'Laparoscopic female sterilization (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]",[],"[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}]",,0.131513,"Intraoperatively, there was a significantly greater leak fraction with the i-gel of 0.06 (0.03) versus 0.04 (0.02) with the LMAS, P=0.013.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Suhitharan', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore.""}, {'ForeName': 'Wendy H L', 'Initials': 'WH', 'LastName': 'Teoh', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore.""}]",Saudi journal of anaesthesia,['10.4103/1658-354X.121081']
2083,24071762,"Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal background therapy with beta-blockers: a 12-week, randomized, double-blind, placebo-controlled trial.","BACKGROUND
The organic nitrate pentaerithrityl tetranitrate (PETN) has been shown to have ancillary properties that prevent the development of tolerance and endothelial dysfunction. This randomized, double-blind, placebo-controlled, multicentre study ('CLEOPATRA' study) was designed to investigate the anti-ischaemic efficacy of PETN 80 mg b.i.d. (morning and mid-day) over placebo in patients with chronic stable angina pectoris.
METHODS AND RESULTS
A total of 655 patients were evaluated in the intention-to-treat population, randomized to PETN (80 mg b.i.d., n = 328) or placebo (n = 327) and completed the study. Patients underwent treadmill exercise tests at randomization, after 6 and 12 weeks of treatment. Treatment with PETN over 12 weeks did not modify the primary endpoint total exercise duration (TED, P = 0.423). In a pre-specified sub-analysis of patients with reduced exercise capacity (TED at baseline ≤9 min, n = 257), PETN appeared more effective than placebo treatment (P = 0.054). Superiority of PETN over placebo was evident in patients who were symptomatic at low exercise levels (n = 120; P = 0.017). Pentaerithrityl tetranitrate 80 mg b.i.d. was well tolerated, and the overall safety profile was comparable with placebo.
CONCLUSION
Although providing no additional benefit in unselected patients with known coronary artery disease, PETN therapy, administered in addition to modern anti-ischaemic therapy, could increase exercise tolerance in symptomatic patients with reduced exercise capacity.",2014,"Treatment with PETN over 12 weeks did not modify the primary endpoint total exercise duration (TED, P = 0.423).","['unselected patients with known coronary artery disease', '655 patients', 'symptomatic patients with reduced exercise capacity', 'patients with chronic stable angina pectoris receiving anti-anginal background therapy with beta-blockers', 'patients with chronic stable angina pectoris']","['treadmill exercise tests', 'placebo', 'pentaerithrityl tetranitrate', 'PETN', 'long-acting nitro vasodilator']","['primary endpoint total exercise duration', 'exercise tolerance', 'overall safety profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030858', 'cui_str': 'pentaerithrityl tetranitrate'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator Drugs'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",655.0,0.546211,"Treatment with PETN over 12 weeks did not modify the primary endpoint total exercise duration (TED, P = 0.423).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': '2. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz, University Medical Center Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinertz', 'Affiliation': ''}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Tebbe', 'Affiliation': ''}, {'ForeName': 'Heinrich Theodor', 'Initials': 'HT', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Stalleicken', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wargenau', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': ''}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Klingmann', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/eht384']
2084,31250880,A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma.,"BACKGROUND
The CDK4/6 inhibitor palbociclib prolongs progression-free survival in hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer when combined with endocrine therapy. This phase II trial was designed to determine the feasibility of adjuvant palbociclib and endocrine therapy for early breast cancer.
PATIENTS AND METHODS
Eligible patients with HR+/HER2- stage II-III breast cancer received 2 years of palbociclib at 125 mg daily, 3 weeks on/1 week off, with endocrine therapy. The primary end point was discontinuation from palbociclib due to toxicity, non-adherence, or events related to tolerability. A discontinuation rate of 48% or higher would indicate the treatment duration of 2 years was not feasible, and was evaluated under a binomial test using a one-sided α = 0.025.
RESULTS
Overall, 162 patients initiated palbociclib; over half had stage III disease (52%) and most received prior chemotherapy (80%). A total of 102 patients (63%) completed 2 years of palbociclib; 50 patients discontinued early for protocol-related reasons (31%, 95% CI 24% to 39%, P = 0.001), and 10 discontinued due to protocol-unrelated reasons. The cumulative incidence of protocol-related discontinuation was 21% (95% CI 14% to 27%) at 12 months from start of treatment. Rates of palbociclib-related toxicity were congruent with the metastatic experience, and there were no cases of febrile neutropenia. Ninety-one patients (56%) required at least one dose reduction.
CONCLUSION
Adjuvant palbociclib is feasible in early breast cancer, with a high proportion of patients able to complete 2 years of therapy. The safety profile in the adjuvant setting mirrors that observed in metastatic disease, with approximately half of the patients requiring dose-modification. As extended duration adjuvant palbociclib appears feasible and tolerable for most patients, randomized phase III trials are evaluating clinical benefit in this population.
CLINICALTRIALS.GOV REGISTRATION
NCT02040857.",2019,The cumulative incidence of protocol-related discontinuation was 21% (95%CI 14-27%) at 12 months from start of treatment.,"['Eligible patients with HR+/HER2- stage II-III breast cancer received 2 years of', 'early breast cancer', '162 patients initiated palbociclib; over half had stage III disease (52%) and most received prior chemotherapy (80', '102 patients (63%) completed 2 years of palbociclib; 50 patients discontinued early for protocol-related reasons (31%, 95%CI 24-39%, p\u2009=\u20090.001), and 10 discontinued due to protocol-unrelated reasons', 'Hormone Receptor Positive Invasive Breast Carcinoma']","['Adjuvant Endocrine Therapy', 'Palbociclib', 'Adjuvant palbociclib', 'palbociclib', 'endocrine therapy', 'adjuvant palbociclib and endocrine therapy']","['Rates of palbociclib-related toxicity', 'cumulative incidence of protocol-related discontinuation', 'febrile neutropenia', 'discontinuation from palbociclib due to toxicity, non-adherence, or events related to tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C4517385', 'cui_str': '0.001 (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast (disorder)'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",102.0,0.0564235,The cumulative incidence of protocol-related discontinuation was 21% (95%CI 14-27%) at 12 months from start of treatment.,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Mayer', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston. Electronic address: emayer@partners.org.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'DeMichele', 'Affiliation': 'Division of Hematology and Oncology, University of Pennsylvania Abramson Cancer Center, Philadelphia.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Division of Hematology and Medical Oncology, University of California San Francisco Helen Diller Comprehensive Cancer Center, San Francisco.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Division of Hematology/Oncology, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Waks', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Come', 'Affiliation': 'Division of Hematology and Oncology, Beth Israel Deaconess Medical Center, Boston.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mulvey', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital Cancer Center, Boston.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jeselsohn', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Overmoyer', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Huang Bartlett', 'Affiliation': 'Pfizer, Inc., New York, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koehler', 'Affiliation': 'Pfizer, Inc., New York, USA.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz198']
2085,23743377,A pilot feasibility multicenter study of patients after excision of endometriosis.,"OBJECTIVE
To serve as a pilot feasibility study for a randomized study of excision versus ablation in the treatment of endometriosis by (1) estimating the magnitude of change in symptoms after excision only at multiple referral centers and (2) determining the proportion of women willing to participate in a randomized trial.
METHODS
We performed a multicenter prospective study of women undergoing excision for endometriosis (Canadian Task Force class II-3) at Duke University Center for Endometriosis Research & Treatment (currently the Saint Louis University Center for Endometriosis), Center for Endometriosis Care, Northshore University Health System, Memorial University (Canada), and Florida Hospital. The study comprised 100 female patients, aged 18 to 55 years, with endometriosis-suspected pelvic pain. The intervention was laparoscopic excision only of the abnormal peritoneum suspicious for endometriosis. The main outcome measures were quality of life, pelvic pain, dysmenorrhea, dyspareunia, and bowel and bladder symptoms.
RESULTS
The mean follow-up period was 8.5 months. Excision of endometriosis showed a significant reduction in all pain scores except bowel symptoms, as well as significant improvement in quality of life. Of the patients, 84% were willing to participate in a randomized study.
CONCLUSIONS
Quality of life is a needed primary outcome for any randomized study comparing excision versus ablation. A multicenter comparative trial is feasible, although quality assurance would have to be addressed. Patients were willing to be randomized even at surgical referral centers.",2013,"Excision of endometriosis showed a significant reduction in all pain scores except bowel symptoms, as well as significant improvement in quality of life.","['women undergoing excision for endometriosis (Canadian Task Force class II-3) at Duke University Center for Endometriosis Research & Treatment (currently the Saint Louis University Center for Endometriosis), Center for Endometriosis Care, Northshore University Health System, Memorial University (Canada), and Florida Hospital', '100 female patients, aged 18 to 55 years, with endometriosis-suspected pelvic pain', 'patients after excision of endometriosis']",['excision versus ablation'],"['pain scores except bowel symptoms', 'quality of life', 'quality of life, pelvic pain, dysmenorrhea, dyspareunia, and bowel and bladder symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0162458', 'cui_str': 'Task Forces'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}]",100.0,0.048686,"Excision of endometriosis showed a significant reduction in all pain scores except bowel symptoms, as well as significant improvement in quality of life.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Yeung', 'Affiliation': ""Department of Obstetrics, Gynecology & Women's Health, Saint Louis University, St. Louis, MO, USA. PYeungl@slu.edu""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tu', 'Affiliation': ''}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Bajzak', 'Affiliation': ''}, {'ForeName': 'Georgine', 'Initials': 'G', 'LastName': 'Lamvu', 'Affiliation': ''}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Guzovsky', 'Affiliation': ''}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Agnelli', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Peavey', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Winer', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Albee', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sinervo', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680812X13517013317833']
2086,24015121,Effects of tranexamic acid during endoscopic sinsus surgery in children.,"OBJECTIVES
This study was conducted to evaluate the effect of tranexamic acid (TA) on the intra-operative bleeding during the functional endoscopic sinus surgery (FESS) in children.
METHODS
A total of 100 children recruited to undergo FESS were randomized into two groups. Group I: Was given just after induction, intra-venous 25 mg/kg TA diluted in 10 ml of normal saline. Group II: Was given 10 ml of normal saline. Non-invasive blood pressure, heart rate, and quality of the surgical field were estimated every 15 min. Volume of bleeding and duration of the surgical procedure were recorded.
RESULTS
Surgical field quality after 15 min revealed that seven patients in group I had minimal bleeding versus no one in group II, P=0.006. Meanwhile, 35 patients in group I had mild bleeding versus 26 patients in group II, P=0.064. Higher number of patients in group II than in group I had moderate bleeding, P=0006. Also, at 30 min, revealed that 10 patients in group I had minimal bleeding versus one patient in group II, P=0.004. Meanwhile, 37 patients in group I had mild bleeding versus 28 patients in group II, P=0.059. Higher number of patients in group II than in group I had moderate bleeding, P<0001. Duration of the surgeries and volume of bleeding were significantly less in tranexamic group than the placebo group, P<0.0001.
CONCLUSION
Single intra-venous bolus dose of tranexamic in children during the FESS improves quality of surgical field, reduces intra-operative bleeding, and duration of surgery.",2013,"RESULTS
Surgical field quality after 15 min revealed that seven patients in group I had minimal bleeding versus no one in group II, P=0.006.","['100 children recruited to undergo FESS', 'children']","['placebo', 'tranexamic acid', 'tranexamic', 'tranexamic acid (TA', 'functional endoscopic sinus surgery (FESS']","['moderate bleeding', 'Volume of bleeding and duration of the surgical procedure', 'mild bleeding', 'quality of surgical field, reduces intra-operative bleeding, and duration of surgery', 'minimal bleeding', 'Surgical field quality', 'Duration of the surgeries and volume of bleeding']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C3267156', 'cui_str': 'Operative bleeding'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",100.0,0.0336104,"RESULTS
Surgical field quality after 15 min revealed that seven patients in group I had minimal bleeding versus no one in group II, P=0.006.","[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Eldaba', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Yasser Mohamed', 'Initials': 'YM', 'LastName': 'Amr', 'Affiliation': ''}, {'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Albirmawy', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115314']
2087,24015122,Effect of hypercapnia on pleth variability index during stable propofol: Remifentanil anesthesia.,"BACKGROUND
The pleth variability index (PVI), which is calculated from respiratory variations in the perfusion index (PI), has been shown to predict fluid responsiveness in mechanically ventilated patients; however, vasomotor tone changes induced by hypercapnia can affect PI and hence may slim down the accuracy of PVI. This study was designed to find out the impact of mild hypercapnia on PVI.
METHODS
A total of 30 patients were randomized after induction of general anesthesia with target controlled infusion propofol and remifentanil to either hypercapnia, (etCO2 =45 mmHg), (group 1, 15 patients) or normocapnia (etCO2 =35 mmHg) (group 2, 15 patients). After a stabilization period of 10 min, patients were crossed over to the other intentional level of etCO2. Heart rate (HR), mean arterial pressure (MAP), PI, PVI were collected at the end of each stabilization period.
RESULTS
Patient characteristics and baseline values of HR, MAP, PI and PVI were comparable between the groups. Carryover effect was statistically excluded. Hypercapnia significantly increased PI and decreased PVI with significant negative correlation.
CONCLUSION
Hypercapnia retracts back PVI values compared with normocapnia. Precise judgment of fluid responsiveness as indicated by PVI necessitates its comparison against similar etCO2 levels.",2013,"RESULTS
Patient characteristics and baseline values of HR, MAP, PI and PVI were comparable between the groups.","['mechanically ventilated patients', 'A total of 30 patients']","['propofol: Remifentanil anesthesia', 'general anesthesia with target controlled infusion propofol and remifentanil to either hypercapnia, (etCO2 =45 mmHg', 'hypercapnia', 'normocapnia (etCO2 =35 mmHg']","['HR, MAP, PI and PVI', 'Carryover effect', 'pleth variability index', 'Heart rate (HR), mean arterial pressure (MAP), PI, PVI', 'Hypercapnia retracts back PVI values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0347823,"RESULTS
Patient characteristics and baseline values of HR, MAP, PI and PVI were comparable between the groups.","[{'ForeName': 'Wesam Farid', 'Initials': 'WF', 'LastName': 'Mousa', 'Affiliation': 'Department of Anesthesia and Surgical ICU, College of Medicine, University of Dammam, Al-Khobar, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115317']
2088,24015124,A comparison of Truview EVO2 laryngoscope with Macintosh laryngoscope in routine airway management: A randomized crossover clinical trial.,"BACKGROUND
The Truview EVO2 blade facilitates the view of vocal cords by indirect laryngoscopy and does not require the proper alignment of the oral, pharyngeal and tracheal axes as with the Macintosh blade.
METHODS
In a crossover fashion, we prospectively compared the view obtained at laryngoscopy with Truview EVO2 and the Macintosh blade in 110 adult patients of either sex between the age of 18 and 60 years, who were scheduled to undergo general anesthesia with endotracheal intubation. The patients were intubated with the second laryngoscope. The preoperative airway variables, laryngoscopic view, difficulty of intubation scale (IDS) score, duration of intubation, and degree of difficulty percentage of glottic opening (POGO score) of use with each laryngoscope were compared.
RESULTS
The IDS score was low and comparable between the two laryngoscopes. The laryngeal view was easy; Modified Cormack Lehane (MCL) grade 2a or less in 98.14% of the cases with the Truview laryngoscope compared to 78.7% of the cases with the Macintosh laryngoscope. Nineteen patients of MCL grade 3, one patient of grade 2b, and seven patients of grade 2a view with the Macintosh laryngoscope had MCL grade 1 view with the Truview laryngoscope. The duration of intubation was comparable between Truview and Macintosh laryngoscopes (12.1±3.8 s vs. 10.9±2.1 s).
CONCLUSION
Truview laryngoscope performed comparably to Macintosh laryngoscope in patients with normal airway; however, the Truview laryngoscope may be a better option in difficult airway situations when the Macintosh blade fails to show the glottic opening.",2013,The IDS score was low and comparable between the two laryngoscopes.,"['110 adult patients of either sex between the age of 18 and 60 years, who were scheduled to undergo general anesthesia with endotracheal intubation', 'Nineteen patients of MCL grade 3, one patient of grade 2b, and seven patients of grade 2a view with the Macintosh laryngoscope had MCL grade 1 view with the Truview laryngoscope', 'routine airway management', 'patients with normal airway']","['view obtained at laryngoscopy with Truview EVO2 and the Macintosh blade', 'Truview EVO2 laryngoscope with Macintosh laryngoscope']","['preoperative airway variables, laryngoscopic view, difficulty of intubation scale (IDS) score, duration of intubation, and degree of difficulty percentage of glottic opening (POGO score) of use with each laryngoscope', 'IDS score', 'duration of intubation']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0150126', 'cui_str': 'Airway Control'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}]",110.0,0.0277292,The IDS score was low and comparable between the two laryngoscopes.,"[{'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Huma', 'Initials': 'H', 'LastName': 'Sayeed', 'Affiliation': ''}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhardwaj', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115322']
2089,31364105,"A pilot study of soft gel technology: a new vaginal device to improve the symptomatology of vulvovaginal atrophy in post-partum, menopause and in patients with recurrent vulvovaginitis.","OBJECTIVE
This is a pilot study to evaluate the effectiveness of the treatment with Vaginal Soft gels technology in the improvement of common signs and symptoms in postmenopausal, postpartum and with recurrent vulvovaginitis patients. These conditions may cause the onset of Vulvovaginal Atrophy (VVA) with effects on sexual activity, self-confidence and daily activities. The main symptoms are itching, irritation and dryness. Many therapies have been evaluated and almost all those without hormonal component have shown poor results.
PATIENTS AND METHODS
Women diagnosed with severe VVA from January to September 2018 were recruited. The study groups were composed of 25 postmenopausal women, 30 post-partum women and 30 women with recurrent vulvovaginitis. For each group, patients were randomized 1:1 among those who carried out the experimental treatment and those that did not perform it. The efficacy of treatment was evaluated with a clinical visit in which Vaginal Health Index (VHI) was estimated. The symptomatology was determined through the questionnaire Female Sexual Function Index (FSFI).
RESULTS
A significant improvement has been shown with regard to the sexual function (orgasm, lubrification, pain) in patients who performed the treatment. A significant increase in VHI has been evaluated in postmenopausal patients (4 months p=0.054, 6 months p=0.005) and in recurrent vulvovaginitis but not in post-partum patients (4 months p=0.681, 6 months p=0.109). An improvement of lubrication, satisfaction, orgasm, pain, as well as dyspareunia, was observed in the three study groups.
CONCLUSIONS
In this pilot study the treatment with soft gels seems to be effective in improving sexual health and atrophy being a treatment available for all types of patients thanks to the absence of systemic and local side effects. It is an excellent alternative especially for patients who cannot use hormones. These findings must be confirmed by larger and randomized further studies.",2019,"An improvement of lubrication, satisfaction, orgasm, pain, as well as dyspareunia, was observed in the three study groups.
","['patients who cannot use hormones', 'Women diagnosed with severe VVA from January to September 2018 were recruited', 'patients with recurrent vulvovaginitis', '25 postmenopausal women, 30 post-partum women and 30 women with recurrent vulvovaginitis', 'postmenopausal, postpartum and with recurrent vulvovaginitis patients']","['soft gel technology', 'Vaginal Soft gels technology']","['lubrication, satisfaction, orgasm, pain, as well as dyspareunia', 'itching, irritation and dryness', 'Vaginal Health Index (VHI', 'recurrent vulvovaginitis', 'symptomatology of vulvovaginal atrophy', 'questionnaire Female Sexual Function Index (FSFI', 'VHI', 'sexual function (orgasm, lubrification, pain', 'sexual activity, self-confidence and daily activities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0042998', 'cui_str': 'Vulvovaginitis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C1318469', 'cui_str': 'Lubrication'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0042998', 'cui_str': 'Vulvovaginitis'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",2018.0,0.0267078,"An improvement of lubrication, satisfaction, orgasm, pain, as well as dyspareunia, was observed in the three study groups.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maniglio', 'Affiliation': ""Department of Surgical and Medical Sciences and Translational Medicine, Sant'Andrea University Hospital, Sapienza University of Rome, Rome, Italy. donatella.caserta@uniroma1.it.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ricciardi', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Meli', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'De Marco', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Costanzi', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Caserta', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201907_18416']
2090,23956720,The comparative evaluation of intravenous with intramuscular clonidine for suppression of hemodynamic changes in laparoscopic cholecystectomy.,"BACKGROUND
Clonidine diminishes stress response by reducing circulating catecholamines and hence increases perioperative circulatory stability in patients undergoing laparoscopic surgeries. The aim of this study was to compare intravenous (IV) clonidine (2 μg/kg) with intramuscular (IM) clonidine (2 μg/kg) for attenuation of stress response in laproscopic surgeries.
METHODS
Eighty adult patients classified as ASA physical status I or II, aged between 20 and 60 years undergoing elective cholecystectomy under general anesthesia were enrolled for a prospective, randomized, and double-blind controlled trial. They received either IV clonidine (2 μg/kg) 15 min prior to the scheduled surgery (Group I) or IM clonidine (2 μg/kg) 60-90 min prior to the scheduled surgery (Group II). Hemodynamic variables (Heart rate, systolic (SBP), diastolic (DBP), mean arterial pressure (MAP)), SpO2 and EtCO2 were recorded at specific times - baseline, prior to induction, 1 min after intubation, before CO2, insufflation, after CO2 insufflation at 1,5,10,20,30,45,60 min, after release of CO2, at 1 and 10 minutes after extubation. Secondary outcomes included evaluation of adverse effect profile of the two groups.
RESULTS
No significant difference was observed in the HR throughout the intraoperative period in between the two groups (P>0.05). There was statistically significant difference in SBP between the two groups starting from 1 minute after induction till 1 min after extubation (P<0.05) but not in DBP except at 1 minute after intubation (P=0.042). Significant difference in MAP was noted at 1 minute after intubation (P=0.004) and then from 5 minutes after CO2 insufflation to 1 minute after extubation (P<0.05). Incidence of adverse effects were higher in group II (P=0.02) especially incidence of hypertension requiring treatment (0.006).
CONCLUSION
We conclude that under the conditions of this study, hemodynamic parameters (SBP, DBP and MAP) were better maintained in the IV as compared to the IM route that had significantly higher incidence of hypertension requiring treatment.",2013,There was statistically significant difference in SBP between the two groups starting from 1 minute after induction till 1 min after extubation (P<0.05) but not in DBP except at 1 minute after intubation (P=0.042).,"['laparoscopic cholecystectomy', 'Eighty adult patients classified as ASA physical status I or II, aged between 20 and 60 years undergoing elective cholecystectomy under general anesthesia', 'patients undergoing laparoscopic surgeries']","['intramuscular (IM) clonidine', 'IM clonidine', 'intramuscular clonidine', 'intravenous (IV) clonidine', 'IV clonidine', 'Clonidine']","['evaluation of adverse effect profile', 'Incidence of adverse effects', 'MAP', 'SBP', 'Hemodynamic variables (Heart rate, systolic (SBP), diastolic (DBP), mean arterial pressure (MAP)), SpO2 and EtCO2', 'hemodynamic changes', 'hemodynamic parameters (SBP, DBP and MAP', 'perioperative circulatory stability']","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",80.0,0.0614709,There was statistically significant difference in SBP between the two groups starting from 1 minute after induction till 1 min after extubation (P<0.05) but not in DBP except at 1 minute after intubation (P=0.042).,"[{'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia and Critical Care, JPNA Trauma Centre, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Arin', 'Initials': 'A', 'LastName': 'Choudhury', 'Affiliation': ''}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Dootika', 'Initials': 'D', 'LastName': 'Liddle', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Verghese', 'Affiliation': ''}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Balakrishnan', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.114070']
2091,24015125,Comparative study of intrathecal hyperbaric versus isobaric ropivacaine: A randomized control trial.,"BACKGROUND
Hyperbaric ropivacaine produce more reliable sensory and motor block, with faster onset, better quality of muscles relaxation than isobaric ropivacaine. So, this study was designed to compare the efficacy of hyperbaric ropivacaine with isobaric ropivacaine in patients undergoing lower abdominal surgery.
METHODS
A randomized controlled double blind study in two groups of patients. group A (n=35) received 3 ml of isobaric ropivacaine 6 mg/ml (18 mg). Group B (n=35) received 3 ml of hyperbaric ropivacaine 6 mg/ml (18 mg). The onset and duration of sensory block at dermatome level T10, maximum upper and lower spread of sensory block, intensity, and duration of motor block were recorded.
STATISTICAL ANALYSIS
Block characteristics were compared using the two-tailed Mann - Whitney U-test. The proportion of side effects was compared using the Chi-square test.
RESULTS
The median time of onset of sensory block at the T10 dermatome was 4.4±1.3 min in group B and 6.0±1.03 min in group A. The median time to maximum block height was 16.7±3.7 min in group A and 12.03±1.96 min in group B. The median duration of complete motor recovery (B0) was significantly shorter in the heavy ropivacaine group (166.5±11.7 min) compared with the isobaric ropivacaine group (192.9±9.6 min).
CONCLUSIONS
Intrathecal hyperbaric ropivacaine provides more rapid, adequate, and good quality of sensory and motor block with rapid post-operative recovery as compare to isobaric ropivacaine.",2013,The median time to maximum block height was 16.7±3.7 min in group A and 12.03±1.96 min in group B.,"['patients undergoing lower abdominal surgery', 'two groups of patients']","['intrathecal hyperbaric versus isobaric ropivacaine', 'Hyperbaric ropivacaine', 'heavy ropivacaine', 'Intrathecal hyperbaric ropivacaine', 'ropivacaine', 'hyperbaric ropivacaine', 'isobaric ropivacaine', '3 ml of isobaric ropivacaine']","['median duration of complete motor recovery (B0', 'onset and duration of sensory block at dermatome level T10, maximum upper and lower spread of sensory block, intensity, and duration of motor block', 'proportion of side effects', 'median time to maximum block height', 'median time of onset of sensory block']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392338', 'cui_str': 'Dermatome (body structure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449244', 'cui_str': 'Time of onset (observable entity)'}]",,0.138864,The median time to maximum block height was 16.7±3.7 min in group A and 12.03±1.96 min in group B.,"[{'ForeName': 'Rajni', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': ""Department of Anaesthesia, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Jaishri', 'Initials': 'J', 'LastName': 'Bogra', 'Affiliation': ''}, {'ForeName': 'Prithvi Kumar', 'Initials': 'PK', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Sulekha', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': ''}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Chandra', 'Affiliation': ''}, {'ForeName': 'Jitendra Kumar', 'Initials': 'JK', 'LastName': 'Kushwaha', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115326']
2092,24015126,"Comparison of the antiemetic effect of ramosetron with the combination of dexamethasone and ondansetron in middle ear surgery: A double-blind, randomized clinical study.","BACKGROUND
Postoperative nausea and vomiting (PONV) is a frequent complication of middle ear surgery. Ondansetron has been shown to be effective for early PONV and dexamethasone has been shown to be effective for late PONV. Therefore, a combination of dexamethasone and ondansetron is commonly used for middle ear surgery. This study was conducted to compare the combination of ondansetron and dexamethasone with ramosetron for early and late PONV up to 48 h after middle ear surgery.
METHODS
One hundred and twenty adults scheduled for middle ear surgery were allocated to receive either dexamethasone 8 mg and ondansetron 4 mg (n=60) or ramosetron 0.3 mg (n=60). General anesthesia with inhalation agents was used for all the patients. The incidence and severity of PONV, administration of rescue antiemetic, and the side effects of the antiemetic were documented during the first 48 h after surgery.
RESULTS
The incidence of nausea was significantly lower in the dexamethasone and ondansetron group compared to the ramosetron group between 2 and 24 h. The complete response, which is patients with no nausea or vomiting, was significantly more in dexamethasone and ondansetron group compared to ramosetron group between 2 and 24 h and between 24 and 48 h (76% vs. 56%, P=0.02, 93% vs. 81%, P=0.05, respectively). Overall, complete response was more in dexamethasone and ondansetron group compared to ramosetron group (71% vs. 40%, P=0.01).
CONCLUSION
The combination of dexamethasone and ondansetron is superior to ramosetron for prevention of PONV after middle ear surgeries.",2013,The incidence of nausea was significantly lower in the dexamethasone and ondansetron group compared to the ramosetron group between 2 and 24 h.,"['middle ear surgery', 'One hundred and twenty adults scheduled for middle ear surgery', 'early and late PONV up to 48 h after middle ear surgery']","['dexamethasone', 'dexamethasone 8 mg and ondansetron', 'ondansetron and dexamethasone with ramosetron', 'ondansetron', 'ramosetron', 'dexamethasone and ondansetron', 'Ondansetron']","['incidence of nausea', 'incidence and severity of PONV, administration of rescue antiemetic, and the side effects of the antiemetic', 'nausea or vomiting']","[{'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0526950', 'cui_str': 'ramosetron'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",120.0,0.17458,The incidence of nausea was significantly lower in the dexamethasone and ondansetron group compared to the ramosetron group between 2 and 24 h.,"[{'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwar, Karnataka, India.'}, {'ForeName': 'M C B', 'Initials': 'MC', 'LastName': 'Santosh', 'Affiliation': ''}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Annigeri', 'Affiliation': ''}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Santoshi', 'Affiliation': ''}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115328']
2093,24015128,Propofol for laryngeal mask airway insertion in children: Effect of two different doses.,"PURPOSE
To compare two different doses of propofol for laryngeal mask airway (LMA) insertion in children undergoing out-patient surgeries.
BACKGROUND
Insertion of LMA just after anesthesia induction is facilitated using propofol. However, the optimal dose of this drug not determined yet as heavy doses may lead to severe complications, whereas lower doses may not be quite as effective.
METHODS
In a double-blind randomized clinical trial, 120 children undergoing out-patient surgeries were recruited to receive intravenous propofol at a dose of either 2.5 mg/kg (group 1) or 3.5 mg/kg (group 2) for induction. Intravenous midazolam (0.03 mg/kg) and fentanyl (1 μg/kg) were used as pre-medication in all patients and anesthesia induction was initiated using lidocaine (1 mg/kg) prior to propofol administration. Hemodynamic changes, probable complications, quality of the established airway and number of attempts for LMA insertion were compared between two groups.
RESULTS
There were no differences in systolic and diastolic blood pressure, heart rate, peripheral oxygen saturation and intraoperative complications between the groups (P>0.05). LMA insertion was successful at the first attempt in 55 (93.2%) and 54 (91.5%) cases in group 1 and group 2, respectively (P>0.05). The efficiency of the established airways was adequate in all the patients of both groups.
CONCLUSION
It seems that propofol doses of 2.5 and 3.5 mg/kg are equally effective for LMA insertion following intravenous midazolam, fentanyl, and lidocaine.",2013,"There were no differences in systolic and diastolic blood pressure, heart rate, peripheral oxygen saturation and intraoperative complications between the groups (P>0.05).","['120 children undergoing out-patient surgeries', 'children', 'children undergoing out-patient surgeries']","['Propofol', 'propofol administration', 'midazolam, fentanyl, and lidocaine', 'lidocaine', 'fentanyl', 'Intravenous midazolam', 'intravenous propofol', 'propofol for laryngeal mask airway (LMA) insertion']","['Hemodynamic changes, probable complications, quality of the established airway and number of attempts for LMA insertion', 'systolic and diastolic blood pressure, heart rate, peripheral oxygen saturation and intraoperative complications']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0396618', 'cui_str': 'Laryngeal mask airway insertion (procedure)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}]",120.0,0.171029,"There were no differences in systolic and diastolic blood pressure, heart rate, peripheral oxygen saturation and intraoperative complications between the groups (P>0.05).","[{'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Seyedhejazi', 'Affiliation': 'Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Eydi', 'Affiliation': ''}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Ghojazadeh', 'Affiliation': ''}, {'ForeName': 'Aref', 'Initials': 'A', 'LastName': 'Nejati', 'Affiliation': ''}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Ghabili', 'Affiliation': ''}, {'ForeName': 'Samad Ej', 'Initials': 'SE', 'LastName': 'Golzari', 'Affiliation': ''}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Iranpour', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115339']
2094,24015131,The effect of addition of intrathecal clonidine to hyperbaric bupivacaine on postoperative pain after lower segment caesarean section: A randomized control trial.,"BACKGROUND
Intrathecal clonidine prolongs spinal anesthesia but the optimum dose to be used in cesarean delivery is not yet known. We evaluated the effect of addition of intrathecal clonidine to hyperbaric bupivacaine on postoperative pain after lower segment caesarean section.
METHODS
A total of 105 parturients carrying a singleton fetus at term, scheduled to undergo elective LSCS under spinal anesthesia were randomized in a double blind fashion to one of the three groups. Group BF (n=35) received 2 ml of 0.5% hyperbaric bupivacaine+25 μg fentanyl, Group BC50 (n=35) received 2 ml of 0.5% hyperbaric bupivacaine+50 μg clonidine, Group BC75 (n=35) received 2 ml of 0.5% hyperbaric bupivacaine+75 μg clonidine.
RESULTS
The duration of postoperative analgesia was 184.73±68.64 min in group BF, 360.71±86.51 min in group BC50 and 760.50±284.03 min in group BC75, P<0.001. The incidence of hypotension was comparable, P=0.932, whereas the incidence of nausea and pruritis was significantly lower in groups BC50 and BC75 as compared to group BF, P<0.001. No other side effects of intrathecal clonidine were detected. Neonatal outcome was similar in all the three groups.
CONCLUSIONS
Addition of 75 μg clonidine to hyperbaric bupivacaine in spinal anesthesia for LSCS significantly prolongs the duration of postoperative analgesia without any increase in maternal side effects. There was no difference in neonatal outcome.",2013,"The incidence of hypotension was comparable, P=0.932, whereas the incidence of nausea and pruritis was significantly lower in groups BC50 and BC75 as compared to group BF, P<0.001.","['105 parturients carrying a singleton fetus at term, scheduled to undergo elective LSCS under spinal anesthesia', 'after lower segment caesarean section']","['2 ml of 0.5% hyperbaric bupivacaine+25 μg fentanyl, Group BC50 (n=35) received 2 ml of 0.5% hyperbaric bupivacaine+50 μg clonidine, Group BC75 (n=35) received 2 ml of 0.5% hyperbaric bupivacaine+75 μg clonidine', 'clonidine', 'hyperbaric bupivacaine', 'intrathecal clonidine']","['maternal side effects', 'neonatal outcome', 'incidence of hypotension', 'postoperative pain', 'Neonatal outcome', 'duration of postoperative analgesia', 'nausea and pruritis']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0195620', 'cui_str': 'Low cervical cesarean section (procedure)'}]","[{'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]",105.0,0.104482,"The incidence of hypotension was comparable, P=0.932, whereas the incidence of nausea and pruritis was significantly lower in groups BC50 and BC75 as compared to group BF, P<0.001.","[{'ForeName': 'Ranju', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Lady Hardinge Medical College and Shrimati Sucheta Kriplani Hospital, New Delhi, India.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115360']
2095,24018083,Use of collapsible box trainer as a module for resident education.,"BACKGROUND AND OBJECTIVES
We sought to determine whether training with a simple collapsible mobile box trainer leads to improved performance of fundamental laparoscopic skills (FLSs) during a 6-month interval versus validated laparoscopic box trainers and virtual-reality trainers, only accessible at a simulation training center.
METHODS
With institutional review board approval, 20 first- and second-year general surgery residents were randomized to scheduled training sessions in a surgical simulation laboratory or training in the use of a portable, collapsible Train Anywhere Skill Kit (TASKit) (Ethicon Endo-Surgery Cincinnati, OH, USA) trainer. Training was geared toward the FLS set for a skill assessment examination at a 6-month interval.
RESULTS
The residents who trained with the TASKit performed the peg-transfer, pattern-cut exercise, Endoloop, and intracorporeal knot-tying FLS tasks statistically more efficiently during their 6-month assessment versus their initial evaluation as compared with the group randomized to the simulation laboratory training.
CONCLUSIONS
Using a simple collapsible mobile box trainer such as the TASKit can be a cost-effective method of training and preparing residents for FLS tasks considering the current cost associated with virtual and highdefinition surgical trainers. This mode of surgical training allows residents to practice in their own time by removing barriers associated with simulation centers.",2013,"BACKGROUND AND OBJECTIVES
We sought to determine whether training with a simple collapsible mobile box trainer leads to improved performance of fundamental laparoscopic skills (FLSs) during a 6-month interval versus validated laparoscopic box trainers and virtual-reality trainers, only accessible at a simulation training center.
","['With institutional review board approval, 20 first- and second-year general surgery residents']","['scheduled training sessions in a surgical simulation laboratory or training in the use of a portable, collapsible Train Anywhere Skill Kit (TASKit) (Ethicon Endo-Surgery Cincinnati, OH, USA) trainer', 'collapsible box trainer', 'simulation laboratory training']",[],"[{'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}]",[],,0.0448355,"BACKGROUND AND OBJECTIVES
We sought to determine whether training with a simple collapsible mobile box trainer leads to improved performance of fundamental laparoscopic skills (FLSs) during a 6-month interval versus validated laparoscopic box trainers and virtual-reality trainers, only accessible at a simulation training center.
","[{'ForeName': 'Angel M', 'Initials': 'AM', 'LastName': 'Caban', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Guido', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Rossidis', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sarosi', 'Affiliation': ''}, {'ForeName': 'Kfir', 'Initials': 'K', 'LastName': 'Ben-David', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680813X13693422521430']
2096,24015133,Prevention of sevoflurane related emergence agitation in children undergoing adenotonsillectomy: A comparison of dexmedetomidine and propofol.,"BACKGROUND
Emergence agitation (EA) in children is increased after sevoflurane anesthesia. Propofol and dexmedetomidine have been used for prophylactic treatment with controversial results. The aim of the present study was to compare the effect of a single dose of propofol or dexmedetomidine prior to termination of sevoflurane-based anesthesia on the incidence and severity of EA in children.
METHODS
One hundred and twenty children, American Society of Anesthesiologists I-II, 2-6 years old undergoing adenotonsillectomy under sevoflurane based anesthesia were enrolled in the study. Children were randomly allocated to one of the three equal groups: (Group C) received 10 ml saline 0.9%, (Group P) received propofol 1 mg/kg or (group D) received dexmedetomidine 0.3 ug/kg(-1). The study drugs were administered 5 min before the end of surgery. In post anesthesia care unit (PACU), the incidence of EA was assessed with Aonos four point scale and the severity of EA was assessed with pediatric anesthesia emergence delirium scale upon admission (T0), after 5 min (T5), 15 min (T15) and 30 min (T30). Extubation time, emergence time, duration of PACU stay and pain were assessed.
RESULTS
The incidence and severity of EA were lower in group P and group D compared to group C at T0, T5 and T15. The incidence and severity of EA in group P were significantly higher than group D at the same times. The incidence and severity of EA decreased significantly over time in all groups. The modified Children's Hospital of Eastern Ontario Pain Scale was significantly lower in group D compared to group C and group P.
CONCLUSIONS
Dexmedetomidine 0.3 ug/kg(1) was more effective than propofol 1 mg/kg in decreasing the incidence and severity of EA, when administered 5 min before the end of surgery in children undergoing adenotonsillectomy under sevoflurane anesthesia.",2013,"The incidence and severity of EA were lower in group P and group D compared to group C at T0, T5 and T15.","['children undergoing adenotonsillectomy under sevoflurane anesthesia', 'children undergoing adenotonsillectomy', 'One hundred and twenty children, American Society of Anesthesiologists I-II, 2-6 years old undergoing adenotonsillectomy under sevoflurane based anesthesia were enrolled in the study', 'children']","['Propofol', 'Dexmedetomidine', '10 ml saline', 'propofol', 'propofol or dexmedetomidine', 'sevoflurane', 'sevoflurane-based anesthesia', 'dexmedetomidine and propofol', 'sevoflurane anesthesia', 'dexmedetomidine 0.3 ug/kg(-1', 'dexmedetomidine']","['Extubation time, emergence time, duration of PACU stay and pain', ""modified Children's Hospital of Eastern Ontario Pain Scale"", 'incidence and severity of EA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}]","[{'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",120.0,0.0977554,"The incidence and severity of EA were lower in group P and group D compared to group C at T0, T5 and T15.","[{'ForeName': 'Monaz Abdulrahman', 'Initials': 'MA', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Menoufiya University, Menufia, Egypt.'}, {'ForeName': 'Ashraf Abualhasan', 'Initials': 'AA', 'LastName': 'Abdellatif', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115363']
2097,24015134,Prophylactic administration of recombinant activated factor VII in coronary revascularization surgery.,"OBJECTIVE
The objective of this clinical trial is to study the effectiveness of administering recombinant activated factor VII (rFVIIa) in reducing the amount of bleeding and the need for homologous blood and products transfusion in cardiac surgical coronary revascularization procedures done under cardiopulmonary bypass (CPB).
METHODS
In a randomized controlled prospective observational study, 30 patients were scheduled for elective cardiac revascularization under CPB. Patients were randomly allocated into two groups. In Group I (Control group), no rFVIIa was administered following CPB. In Group II (Study group), a dose of 90 ug/Kg of rFVIIa was administered following weaning off CPB. The total amount of chest tube drain during the 1(st) 24 h following surgery was recorded as well as the qualitative and quantitative assessments of homologous blood and products transfusion. Serial analysis of hematological parameters including hemoglobin level and coagulation test in a definite data points was done. T0=baseline readings prior to CPB, T1=off CPB after protamine administration and before administration of the study drug, T2=on Cardiac Intensive Care Unit (CICU) admission, T3=12 h post-CICU admission, and T4=24 h post-CICU admission.
RESULTS
Considering the total chest tube drainage, mean values showed statistically significant results with a P value of 0.001. Homologous blood and products transfusion were statistically lower in the study group. Regarding the mean values for hematological assessment, results showed statistically lower International Normalized Ratio values at CICU admission and 12 h post-CICU admission with a P value of 0.018 and 0.004, respectively. Also, the Partial Thromboplastin Time mean values were statistically lower at same timings with estimated P values of 0.04 and 0.001, respectively.
CONCLUSION
It is concluded that the prophylactic use of rFVIIa in patients undergoing coronary revascularization surgery under the management of CPB had a remarkable significant results on both the amount of post-operative bleeding and the amount of blood and products transfusion.",2013,"Regarding the mean values for hematological assessment, results showed statistically lower International Normalized Ratio values at CICU admission and 12 h post-CICU admission with a P value of 0.018 and 0.004, respectively.","['coronary revascularization surgery', '30 patients were scheduled for elective cardiac revascularization under CPB', 'cardiac surgical coronary revascularization procedures done under cardiopulmonary bypass (CPB', 'patients undergoing coronary revascularization surgery']","['recombinant activated factor VII', 'rFVIIa', 'recombinant activated factor VII (rFVIIa']","['Partial Thromboplastin Time mean values', 'hemoglobin level and coagulation test', 'total amount of chest tube drain', 'Homologous blood and products transfusion']","[{'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0015505', 'cui_str': 'Factor VIIa'}, {'cui': 'C0534191', 'cui_str': 'recombinant FVIIa'}]","[{'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1504378', 'cui_str': 'Coagulation test'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0005768'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]",30.0,0.0372251,"Regarding the mean values for hematological assessment, results showed statistically lower International Normalized Ratio values at CICU admission and 12 h post-CICU admission with a P value of 0.018 and 0.004, respectively.","[{'ForeName': 'Mohamed Essam', 'Initials': 'ME', 'LastName': 'Abdel-Meguid', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Ain Shams University, Egypt and King Fahad Specialist Hospital, KSA.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115364']
2098,24015135,Efficacy of diltiazem as an adjunct to lignocaine in intravenous regional anesthesia.,"BACKGROUND
Various adjuncts have been used with lignocaine to decrease tourniquet pain and prolong post-operative analgesia during intravenous regional anesthesia (IVRA). Calcium-channel blockers potentiate the analgesic effect of local anesthetics. This study was designed to evaluate the efficacy of diltiazem as an adjunct to lignocaine in IVRA with respect to tourniquet tolerance, perioperative analgesia, and quality of anesthesia.
METHODS
In this prospective, randomized, and double-blind study, 40 patients (American Society for Anesthesiologists grade I/II) undergoing elective hand surgery under IVRA were assigned into two groups of 20 each and administered IVRA either with lignocaine 3 mg/kg (group Lignocaine (L)) or lignocaine 3 mg/kg plus diltiazem 0.2 mg/kg (group Lignocaine-Diltiazem (LD)) with normal saline (total volume-40 ml). Hemodynamic parameters, onset of the complete sensory blockade, motor blockade, and intraoperative (tourniquet pain) and post-operative Visual Analogue Scale scores, total intraoperative and consumption of post-operative fentanyl intraoperative were recorded.
RESULTS
Sensory block was established in 2.5±0.688 min in group LD verses 5.60±0.851 min in group L. Motor blockade was established in 8.65±0.933 min in group LD and 13.46±0.604 min in group L. The mean VAS scores >3 were attained early at 30 min (3.1±0.912) in group L. Patients in group L requested early rescue analgesic at 30±8.633 min compared with 49.64±7.958 min in group LD.
CONCLUSIONS
Diltiazem as an adjunct to lignocaine provided enhanced intraoperative and post-operative analgesia without any significant side effects.",2013,"RESULTS
Sensory block was established in 2.5±0.688 min in group LD verses 5.60±0.851 min in group L. Motor blockade was established in 8.65±0.933 min in group LD and 13.46±0.604 min in group L.","['40 patients (American Society for Anesthesiologists grade I/II) undergoing elective hand surgery under IVRA', 'intravenous regional anesthesia']","['Lignocaine (L)) or lignocaine 3 mg/kg plus diltiazem 0.2 mg/kg (group Lignocaine-Diltiazem (LD)) with normal saline (total volume-40 ml', 'Diltiazem', 'lignocaine', 'diltiazem', 'Calcium-channel blockers']","['tourniquet pain', 'mean VAS scores', 'Hemodynamic parameters, onset of the complete sensory blockade, motor blockade, and intraoperative (tourniquet pain) and post-operative Visual Analogue Scale scores, total intraoperative and consumption of post-operative fentanyl intraoperative', 'early rescue analgesic', 'tourniquet tolerance, perioperative analgesia, and quality of anesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]",40.0,0.0809294,"RESULTS
Sensory block was established in 2.5±0.688 min in group LD verses 5.60±0.851 min in group L. Motor blockade was established in 8.65±0.933 min in group LD and 13.46±0.604 min in group L.","[{'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Khanna', 'Affiliation': 'Department of Anaesthesia, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Virender Kumar', 'Initials': 'VK', 'LastName': 'Mohan', 'Affiliation': ''}, {'ForeName': 'Rani Achanpa', 'Initials': 'RA', 'LastName': 'Sunder', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.115359']
2099,23956707,Analgesic efficacy of peritubal infiltration of ropivacaine versus ropivacaine and morphine in percutaneous nephrolithotomy under ultrasonic guidance.,"BACKGROUND AND PURPOSE
Percutaneous nephrolithotomy is a safe and effective endourologic procedure which is less morbid than open surgery. However, pain around a nephrostomy tube requires good post-operative analgesia. We hypothesize that infiltration of local anesthetic with opioid from the renal capsule to the skin around the nephrostomy tract under ultrasonic guidance would alleviate the postoperative pain for a long period.
METHODS
A total of 60 ASA physical status I to II patients were selected for a prospective randomized double-blind controlled study in percutaneous nephrolithotomy surgeries. Patients were divided into group R (n=30) and group RM (n=30). Balanced general anesthesia was given. After completion of the surgical procedure, a 23-gauze spinal needle was inserted at 6 and 12 O'clock position under ultrasonic guidance up to renal capsule along the nephrostomy tube. A 10 ml drug solution was infiltrated in each tract while withdrawing from renal capsule to the skin. After extubation, the patient was shifted to the post-anesthesia care unit for 24 hours. Post-operative pain was assessed using the visual analog scale (VAS) and dynamic visual analog scale (DVAS) (during deep breathing and coughing) rating 0-10 for initial 24 hours. Rescue analgesia was given in the form of injection tramadol 1.0 mg/kg intravenously when VAS ≥4 and maximum up to 400 mg in 24 hours. Time to 1(st) rescue analgesic, number of doses of tramadol and total consumption of tramadol required in initial 24 hours were noted. Patients were observed for any side effect and treated accordingly.
RESULTS
Time to 1(st) rescue analgesic, i.e., duration of analgesia in group RM is more prolonged than group R (P=0.0004). The number of doses of tramadol in 24 hours in group R were higher as compared to group RM (P=0.0003). The total amount of tramadol in 24 hours in group R was more than in group RM (P=0.0013). Side effects like nausea and vomiting and sedation were comparable in both the groups.
CONCLUSION
Addition of morphine to ropivacaine for nephrostomy tract infiltration significantly prolonged the duration of post-operative analgesia and reduced the number of doses and total consumption of rescue analgesic in initial 24 hours in percutaneous nephrolithotomy surgery.",2013,The total amount of tramadol in 24 hours in group R was more than in group RM (P=0.0013).,"['60 ASA physical status I to II patients', 'percutaneous nephrolithotomy under ultrasonic guidance']","['morphine', 'percutaneous nephrolithotomy surgery', 'percutaneous nephrolithotomy surgeries', 'ropivacaine and morphine', 'Percutaneous nephrolithotomy', 'tramadol', 'ropivacaine']","['total amount of tramadol', 'nausea and vomiting and sedation', 'Time to 1(st) rescue analgesic, i.e., duration of analgesia', 'number of doses of tramadol', 'Time to 1(st) rescue analgesic, number of doses of tramadol and total consumption of tramadol', 'postoperative pain', 'visual analog scale (VAS) and dynamic visual analog scale (DVAS', 'duration of post-operative analgesia', 'number of doses and total consumption of rescue analgesic', 'Analgesic efficacy']","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",60.0,0.0294716,The total amount of tramadol in 24 hours in group R was more than in group RM (P=0.0013).,"[{'ForeName': 'Geeta P', 'Initials': 'GP', 'LastName': 'Parikh', 'Affiliation': 'Department of Anaesthesia and Critical Care, Smt. K. M. Mehta and Smt. G. R. Doshi Institute of Kidney Diseases and Research Center, Dr. H. L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Veena R', 'Initials': 'VR', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Kalpana S', 'Initials': 'KS', 'LastName': 'Vora', 'Affiliation': ''}, {'ForeName': 'Manisha P', 'Initials': 'MP', 'LastName': 'Modi', 'Affiliation': ''}, {'ForeName': 'Tanu', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sonde', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.114046']
2100,23956709,Dose sparing of induction dose of propofol by fentanyl and butorphanol: A comparison based on entropy analysis.,"BACKGROUND
The induction dose of propofol is reduced with concomitant use of opioids as a result of a possible synergistic action.
AIM AND OBJECTIVES
The present study compared the effect of fentanyl and two doses of butorphanol pre-treatment on the induction dose of propofol, with specific emphasis on entropy.
METHODS
Three groups of 40 patients each, of the American Society of Anaesthesiologistsphysical status I and II, were randomized to receive fentanyl 2 μg/kg (Group F), butorphanol 20 μg/kg (Group B 20) or 40 μg/kg (Group B 40) as pre-treatment. Five minutes later, the degree of sedation was assessed by the observer's assessment of alertness scale (OAA/S). Induction of anesthesia was done with propofol (30 mg/10 s) till the loss of response to verbal commands. Thereafter, rocuronium 1 mg/kg was administered and endotracheal intubation was performed 2 min later. OAA/S, propofol induction dose, heart rate, blood pressure, oxygen saturation and entropy (response and state) were compared in the three groups.
STATISTICAL ANALYSIS
Data was analyzed using ANOVA test with posthoc significance, Kruskal-Wallis test, Chi-square test and Fischer exact test. A P<0.05 was considered as significant.
RESULTS
The induction dose of propofol (mg/kg) was observed to be 1.1±0.50 in Group F, 1.05±0.35 in Group B 20 and 1.18±0.41 in Group B40. Induction with propofol occurred at higher entropy values on pre-treatment with both fentanyl as well as butorphanol. Hemodynamic variables were comparable in all the three groups.
CONCLUSION
Butorphanol 20 μg/kg and 40 μg/kg reduce the induction requirement of propofol, comparable to that of fentanyl 2 μg/kg, and confer hemodynamic stability at induction and intubation.",2013,"Hemodynamic variables were comparable in all the three groups.
","['Three groups of 40 patients each, of the American Society of Anaesthesiologistsphysical status I and II']","['Butorphanol', 'rocuronium', 'fentanyl', 'propofol', 'butorphanol']","['hemodynamic stability', 'OAA/S, propofol induction dose, heart rate, blood pressure, oxygen saturation and entropy (response and state', 'degree of sedation', 'Hemodynamic variables', 'alertness scale (OAA/S']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0222045'}]",,0.075711,"Hemodynamic variables were comparable in all the three groups.
","[{'ForeName': 'Jasleen', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Gian Sagar Medical College and Hospital, Banur, Patiala, Punjab, India.'}, {'ForeName': 'Moningi', 'Initials': 'M', 'LastName': 'Srilata', 'Affiliation': ''}, {'ForeName': 'Durga', 'Initials': 'D', 'LastName': 'Padmaja', 'Affiliation': ''}, {'ForeName': 'Ramchandran', 'Initials': 'R', 'LastName': 'Gopinath', 'Affiliation': ''}, {'ForeName': 'Sukhminder Jit Singh', 'Initials': 'SJ', 'LastName': 'Bajwa', 'Affiliation': ''}, {'ForeName': 'Dorairay John', 'Initials': 'DJ', 'LastName': 'Kenneth', 'Affiliation': ''}, {'ForeName': 'Parasa Sujay', 'Initials': 'PS', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Chalumuru', 'Initials': 'C', 'LastName': 'Nitish', 'Affiliation': ''}, {'ForeName': 'Wudaru Sreedhar', 'Initials': 'WS', 'LastName': 'Reddy', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.114052']
2101,23956710,"Infraclavicular brachial plexus block: Comparison of posterior cord stimulation with lateral or medial cord stimulation, a prospective double blinded study.","BACKGROUND
Infraclavicular approach to the brachial plexus sheath provides anesthesia for surgery on the distal arm, elbow, forearm, wrist, and hand. It has been found that evoked distal motor response or radial nerve-type motor response has influenced the success rate of single-injection infraclavicular brachial plexus block.
AIM
We conducted this study to compare the extent and effectiveness of infraclavicular brachial plexus block achieved by injecting a local anesthetic drug after finding specific muscle action due to neural stimulator guided posterior cord stimulation and lateral cord/medial cord stimulation.
METHODS
After ethical committee approval, patients were randomly assigned to one of the two study groups of 30 patients each. In group 1, posterior cord stimulation was used and in group 2 lateral/medial cord stimulation was used for infraclavicular brachial plexus block. The extent of motor block and effectiveness of sensory block were assessed.
RESULTS
All four motor nerves that were selected for the extent of block were blocked in 23 cases (76.7%) in group 1 and in 15 cases (50.0%) in group 2 (P:0.032). The two groups did not differ significantly in the number of cases in which 0, 1, 2, and 3 nerves were blocked (P>0.05). In group 1, significantly lesser number of patients had pain on surgical manipulation compared with patients of group 2 (P:0.037).
CONCLUSION
Stimulating the posterior cord guided by a nerve stimulator before local anesthetic injection is associated with greater extent of block (in the number of motor nerves blocked) and effectiveness of block (in reporting no pain during the surgery) than stimulation of either the lateral or medial cord.",2013,"The two groups did not differ significantly in the number of cases in which 0, 1, 2, and 3 nerves were blocked (P>0.05).",[],"['infraclavicular brachial plexus block', 'posterior cord stimulation with lateral or medial cord stimulation']",['pain on surgical manipulation'],[],"[{'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach (procedure)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]",,0.120174,"The two groups did not differ significantly in the number of cases in which 0, 1, 2, and 3 nerves were blocked (P>0.05).","[{'ForeName': 'Dushyant', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, PGIMER, Dr. Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Srivastava', 'Affiliation': ''}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Pawar', 'Affiliation': ''}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Vijay Kumar', 'Initials': 'VK', 'LastName': 'Nagpal', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.114054']
2102,23956711,"Does dexamethasone prevent subarachnoid meperidin-induced nausea, vomiting and pruritus after cesarean delivery?","BACKGROUND
Opioid-induced side effects such as nausea and vomiting and pruritus are common and may be more debilitating than pain itself. We performed a study to assess the efficacy of dexamethasone in reducing postoperative nausea, vomiting, and pruritus in patients receiving neuraxial anesthesia with meperidine.
METHODS
Fifty-two women undergoing cesarean section were enrolled in the study. The control group and dexamethasone group received intravenously normal saline and dexamethasone, respectively, before spinal anesthesia. The occurrence of postoperative nausea, vomiting, and pruritus was assessed for 24 h in both groups.
RESULTS
The overall incidence of nausea and vomiting during the 24 h follow-up period was 37% and 22.2% for group saline and 20% and 12% for group dexamethasone, respectively (P=0.175, 0.469). The incidence of pruritus was not significantly different between the two groups. Pruritus severity was significantly less in the dexamethasone group than in the saline group (P=0.019).
CONCLUSION
Prophylactic dexamethasone does not reduce the incidence of subarachnoid meperidine-induced nausea, vomiting, and pruritus in women undergoing cesarean delivery.",2013,"Pruritus severity was significantly less in the dexamethasone group than in the saline group (P=0.019).
","['women undergoing cesarean delivery', 'Fifty-two women undergoing cesarean section were enrolled in the study', 'patients receiving neuraxial anesthesia with meperidine']","['Prophylactic dexamethasone', 'intravenously normal saline and dexamethasone', 'dexamethasone']","['postoperative nausea, vomiting, and pruritus', 'nausea and vomiting', 'nausea, vomiting, and pruritus', 'incidence of pruritus', 'nausea, vomiting and pruritus', 'Pruritus severity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",52.0,0.201815,"Pruritus severity was significantly less in the dexamethasone group than in the saline group (P=0.019).
","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Banihashem', 'Affiliation': 'Department of Anaesthesia, Babol University of Medical Science, Babol, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Hasannasab', 'Affiliation': ''}, {'ForeName': 'Hakimeh', 'Initials': 'H', 'LastName': 'Alereza', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.114057']
2103,32059954,All-Inside Quadrupled Semitendinosus Autograft Shows Stability Equivalent to Patellar Tendon Autograft Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial in Athletes 24 Years or Younger.,"PURPOSE
To compare clinical outcomes of knee anterior cruciate ligament (ACL) autograft reconstruction using all-inside quadrupled semitendinosus (AIST) versus bone-patellar tendon-bone (BPTB) in a high-risk athletic population 24 years or younger.
METHODS
Skeletally mature candidates younger than 24 years old with an ACL tear were randomized into either the AIST (n = 32) or BPTB (n = 32) group and were followed for 2 years. Magnetic resonance imaging scans were obtained at 1-year follow-up, and radiographs were obtained at 2-year follow-up. All surgeries were performed by a single surgeon using an anteromedial portal to establish the femoral tunnel. The primary outcome measure was KT-1000 stability testing. Secondary outcome measures included International Knee Documentation Committee (IKDC) Knee Evaluation Form, IKDC Subjective Form, Knee Injury and Osteoarthritis Outcome Score, Marx Activity Scale, visual analog pain scale, and SF-12 (Mental and Physical).
RESULTS
At 2-year follow-up, no statistical difference existed with KT-1000-measured side-to-side laxity between AIST (0.3 ± 0.7 mm, 95% confidence interval 0.0-1.0 mm) and BPTB (0.0 ± 0.8 mm, confidence interval CI -0.3 to 1.1 mm) (P = .197). In addition, no statistical differences between the groups were found for IKDC Subjective Form, Knee Injury and Osteoarthritis Outcome Score, Marx, SF-12 Mental, SF-12 Physical, or with regards to imaging findings. Patients with BPTB reported significantly greater postoperative pain scores at days 2 (P = .049), 3 (P = .004), and 7 (P = .015) and had significantly greater kneeling pain at 2 years (P < .019). A return to sport questionnaire at 2 years revealed no significant difference between the groups for returning to preoperative level of sport activity (83% AIST, 74% BPTB; P = .415). Two graft retears (7%; P = .222) occurred in the AIST group. Three patients in the BPTB group experienced ACL tears in the contralateral knee (9%; P = .239).
CONCLUSIONS
ACL reconstruction with an all-inside quadrupled semitendinosus autograft construct is equivalent to patellar BPTB autograft based on KT-1000 stability testing in athletes 24 years or younger.
LEVEL OF EVIDENCE
randomized controlled trial with 92% 2-year follow-up, Level I.",2020,"A return to sport questionnaire at 2 years revealed no significant difference between the groups for returning to preoperative level of sport activity (83% AIST, 74% BPTB; p=0.415).","['Skeletally mature candidates younger than 24 years old with an ACL tear', 'Patellar Tendon Autograft Anterior Cruciate Ligament Reconstruction', 'high-risk athletic population 24 years or younger', 'Athletes 24 Years or Younger', 'athletes 24 years or younger']","['AIST', 'BPTB', 'patellar BPTB autograft based on KT-1000 stability testing', 'knee anterior cruciate ligament (ACL) autograft reconstruction using all-inside quadrupled semitendinosus (AIST) versus bone-patellar tendon-bone (BPTB']","['KT- 1000 stability testing', 'KT-1000 measured side to side laxity', 'ACL tears', 'IKDC Knee Evaluation Form, IKDC Subjective Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Marx Activity Scale, VAS Pain Scale and SF-12 (Mental and Physical', 'kneeling pain', 'MRIs', 'preoperative level of sport activity', 'postoperative pain scores', 'IKDC Subjective Form, KOOS, Marx, SF-12 Mental, SF-12 Physical or with regards to imaging findings']","[{'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C0206332', 'cui_str': 'Ligamentum Patellae'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0078960', 'cui_str': 'Anterior Cranial Cruciate Ligament'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0206332', 'cui_str': 'Ligamentum Patellae'}]","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1260920', 'cui_str': 'Kneeling (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1287399', 'cui_str': 'Imaging finding'}]",,0.0468013,"A return to sport questionnaire at 2 years revealed no significant difference between the groups for returning to preoperative level of sport activity (83% AIST, 74% BPTB; p=0.415).","[{'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri, Columbia, Missouri, U.S.A.; Columbia Orthopaedic Group, Columbia, Missouri, U.S.A.. Electronic address: psmithmudoc@aol.com.'}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Cook', 'Affiliation': 'Columbia Orthopaedic Group, Columbia, Missouri, U.S.A.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Bley', 'Affiliation': 'Columbia Orthopaedic Group, Columbia, Missouri, U.S.A.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.01.048']
2104,21189851,Cisatracurium in different doses versus atracurium during general anesthesia for abdominal surgery.,"BACKGROUND
Cisatracurium in clinical practice is devoid of histamine-induced cardiovascular effects. On the other hand, 2 ED(95) doses of cisatracurium (100 µ g/kg) do not create satisfactory intubating conditions such as those seen with equipotent doses of atracurium. The recommended intubating dose of cisatracurium is 3 ED(95). To understand this discrepancy better, we evaluated the potency and onset of atracurium and cisatracurium.
MATERIALS AND METHODS
The study designed as randomized controlled clinical trial to compare between atracurium (2×ED(95)) and different doses of cisatracurium (2×ED(95), 4×ED(95), 6×ED(95)) regarding onset time, duration of action, condition of intubation, hemodynamic effects, and sings of histamine release clinically. Sixty four patients were randomly assigned to one of four groups, the first group (group 1) received 2×ED(95) dose of atracurium, group 2 received 2×ED(95) dose of cisatracurium, group 3 received 4×ED(95) dose of cisatracurium, while group 4 received 6×ED(95) dose of cisatracurium. The Datex relaxograph (Type NMT-100-23-01, S/N: 37541) for neuromuscular monitoring was used.
RESULTS
HR, MABP was statistically significant increased post-intubation with administration of 2×ED(95) dose of atracurium in group 1 and the same dose of cisatracurium in group 2 but 5-20 min later was not statistically significant with administration of 4×ED(95) and 6×ED(95) doses of cisatracurium in groups 3 and 4, respectively. Onset time was found to be significantly lower with 2×ED(95) dose of atracurium than with the same dose of cisatracurium. At the same time, higher doses of cisatracurium (4×ED(95) and 6×ED(95)) showed onset time and longer duration of action that was significantly lower than with atracurium and with lower dose of cisatracurium (2×ED(95)). Only 6×ED(95) dose of cisatracurium showed statistically significant difference versus the atracurium dose with higher percentages of patients with excellent condition of intubation. 4×ED(95) and 6×ED(95) doses of cisatracurium were significantly better than 2×ED(95) dose of cisatracurium. 2×ED(95) dose of atracurium and 2×ED(95) dose of cisatracurium were similar, while 4×ED(95) and 6×ED(95) doses of cisatracurium were significantly better than atracurium and 2×ED(95) dose of cisatracurium.
CONCLUSION
The same dose (2×ED(95) dose) atracurium is more effective neuromuscular blocking agent than cisatracurium, while higher doses of cisatracurium 4×ED(95) and 6×ED(95) provide more effective, more rapid neuromuscular blocking with longer duration of action, stable hemodynamic status, and no associated signs of histamine release clinically.",2010,Only 6×ED(95) dose of cisatracurium showed statistically significant difference versus the atracurium dose with higher percentages of patients with excellent condition of intubation.,"['Sixty four patients', 'abdominal surgery']","['cisatracurium (2×ED(95), 4×ED(95), 6×ED(95', '6×ED(95', 'atracurium and 2×ED(95', 'atracurium', 'cisatracurium', '2×ED(95) dose of atracurium, group 2 received 2×ED(95) dose of cisatracurium, group 3 received 4×ED(95) dose of cisatracurium, while group 4 received 6×ED(95) dose of cisatracurium', 'atracurium (2×ED(95']","['onset time and longer duration of action', 'regarding onset time, duration of action, condition of intubation, hemodynamic effects, and sings of histamine release clinically']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}]","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0019595', 'cui_str': 'Histamine Liberation'}]",64.0,0.120978,Only 6×ED(95) dose of cisatracurium showed statistically significant difference versus the atracurium dose with higher percentages of patients with excellent condition of intubation.,"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'El-Kasaby', 'Affiliation': 'Department of Anaesthesia, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Atef', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Helmy', 'Affiliation': ''}, {'ForeName': 'M Abo', 'Initials': 'MA', 'LastName': 'El-Nasr', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.71571']
2105,32426888,Preschoolers exhibit greater on-task behavior following physically active lessons on the approximate number system.,"OBJECTIVE
To determine how the dual-task nature of incorporating physical activity with instructional activities immediately impacts acuity of the approximate number system and on-task behavior in preschoolers.
METHODS
Using a randomized within-participants repeated-measures crossover design, 51 children completed an approximate number system task before and after either 20-min of physically active instruction corresponding to 38% heart rate reserve (HRR; light-to-moderate intensity) or conventional sedentary instruction at corresponding to 21% HRR (very light intensity).
RESULTS
Findings revealed that preschool-aged children exhibited similar learning and greater on-task behavior following a single bout of physically active instruction relative to conventional sedentary instruction. Overall, preschoolers accrued 931.3 ± 8.2 more steps and an additional 9 minutes at or above light-intensity activity during the physically active instruction.
CONCLUSION
Accordingly, these findings suggest that the dual-task nature of physically active learning does not compromise learning, reduces the need for redirecting off-task behavior, and ultimately allows children to avoid sedentary behavior in educational contexts.",2020,"RESULTS
Findings revealed that preschool-aged children exhibited similar learning and greater on-task behavior following a single bout of physically active instruction relative to conventional sedentary instruction.","['preschoolers', '51 children completed an']",['approximate number system task before and after either 20-min of physically active instruction corresponding to 38% heart rate reserve (light-to-moderate intensity) or conventional sedentary instruction at corresponding to 21% heart rate reserve (very light intensity'],['task behavior'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439538', 'cui_str': 'Very light'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",51.0,0.058158,"RESULTS
Findings revealed that preschool-aged children exhibited similar learning and greater on-task behavior following a single bout of physically active instruction relative to conventional sedentary instruction.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'McGowan', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Ferguson', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Hope K', 'Initials': 'HK', 'LastName': 'Gerde', 'Affiliation': 'Human Development and Family Studies, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Karin A', 'Initials': 'KA', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Pontifex', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13727']
2106,23956712,Hemiarthroplasty in high risk elderly patient under epidural anesthesia with 0.75% ropivacaine-fentanyl versus 0.5% bupivacaine-fentanyl: Clinical trial.,"BACKGROUND
Anesthetic management of elderly patients is a challenge as aging makes them more susceptible to hemodynamic fluctuations during regional anesthesia. This study was aimed to compare the clinical efficacy of epidural 0.75% ropivacaine fentanyl (RF)- with 0.5% bupivacaine-fentanyl (BF) for hemiarthroplasty in high-risk elderly patients.
METHODS
Sixty elderly consented patients of either sex with American Society of Anesthesiologist ASA II and III, scheduled for elective hemiarthroplasty were randomized into two Groups of 30 patients to receive epidural study solution of 15 mL of 0.75% Ropivacaine or 0.5% Bupivacaine with 1 mL fentanyl (50 μg). The hemodynamic variability with onset and duration of sensory and motor blocks were recorded. The adequacy and quality of surgical anesthesia were assessed. The post-epidural nausea and vomiting, shivering, respiratory parameters, or any other side effects were also recorded.
RESULTS
There was no difference in the demographic profile between groups. The mean onset time to achieve sensory block to the T10 dermatome was rapid in the Group BF (12.4±6.9 vs. 17.5±3.7 min in Group RF). The mean time to achieve motor block was 17.5±3.4 min in Group BF versus 21.7±7.8 min in Group RF. The intraoperative hemodynamic fluctuations showed statistically significant differences between groups. The pruritis was observed in five patients but post-epidural shivering, nausea, vomiting, respiratory depression, or urinary retention were not observed in any patient.
CONCLUSION
Epidural 0.75% Ropivacaine with fentanyl showed better clinical profile as compared to 0.5% Bupivacaine with fentanyl for hemiarthroplasty in elderly patients.",2013,The intraoperative hemodynamic fluctuations showed statistically significant differences between groups.,"['high-risk elderly patients', 'elderly patients', 'Sixty elderly consented patients of either sex with American Society of Anesthesiologist ASA II and III, scheduled for elective hemiarthroplasty', 'high risk elderly patient under epidural anesthesia with 0.75']","['Hemiarthroplasty', 'ropivacaine-fentanyl', 'epidural study solution of 15 mL of 0.75% Ropivacaine or 0.5% Bupivacaine with 1 mL fentanyl', 'fentanyl', 'Bupivacaine', 'epidural 0.75% ropivacaine fentanyl (RF)- with 0.5% bupivacaine-fentanyl (BF', 'Ropivacaine', 'bupivacaine-fentanyl']","['adequacy and quality of surgical anesthesia', 'mean time to achieve motor block', 'intraoperative hemodynamic fluctuations', 'hemodynamic variability with onset and duration of sensory and motor blocks', 'mean onset time to achieve sensory block', 'clinical efficacy', 'demographic profile', 'post-epidural nausea and vomiting, shivering, respiratory parameters, or any other side effects', 'nausea, vomiting, respiratory depression, or urinary retention']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}]",60.0,0.0337145,The intraoperative hemodynamic fluctuations showed statistically significant differences between groups.,"[{'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Rastogi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, N.S.C.B., Subharti Medical College, Subhartipuram, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Kumkum', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': ''}, {'ForeName': 'Prashant K', 'Initials': 'PK', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Apoorva B', 'Initials': 'AB', 'LastName': 'Singhal', 'Affiliation': ''}, {'ForeName': 'Ivesh', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.114058']
2107,23956714,N-acetylcysteine instead of theophylline in patients with COPD who are candidates for elective off-pump CABG surgery: Is it possible in cardiovascular surgery unit?,"BACKGROUND
Forced expiratory volume in one second (FEV1) is a good predictor of chronic obstructive pulmonary disease (COPD). COPD is characterized by a chronic limitation of airflow. This study was designed to compare the effects and complications of theophylline alone, N-acetylcysteine (NAC) alone, and a combination of the two drugs on the rates of FEV1 in patients with COPD who were candidates for off-pump coronary artery bypass graft (CABG) surgery.
METHODS
This clinical trial was performed on 100 patients who had a smoking history of 27 pack years with a range of 20 to 40 pack years but were not heavy smokers and were candidates for elective off-pump CABG surgery in Afshar Cardiovascular Hospital, Yazd, Iran. The patients with a history of asthma and bronchospasm and non-COPD respiratory disorders were excluded. There were three groups, that is, the theophylline group (n=33) that received theophylline 10 mg/kg TDS after consumption of food, NAC group (n=33) who received NAC 10-15 mg/kg BD after consumption of food, and the combined group (n=32) who received theophylline and NAC together. Data were analyzed by analysis of variance (ANOVA), Chi-square, and exact test for quantitative and qualitative variables.
RESULTS
One hundred patients with COPD enrolled in this study as possible candidates for CABG surgery. Average age of the patients was 60.36±10.21 years. Of the participants, 83 (83.3%) were male and 17 (17%) were female. Rate of postoperative FEV1 to basal FEV1 was 0.76±0.32, 0.66±0.22, and 0.69±0.24 in the treatments with theophylline, NAC, and the combination, respectively. Theophylline, NAC, and a combination of these drugs can decrease the rate of postoperative FEV1 compared to basal FEV1 significantly. (P=0.0001).
CONCLUSION
Theophylline alone, NAC alone, and a combination of these drugs improve pulmonary function, and there are no significant differences between these protocols. Stomach discomfort and cardiac complications in treatment with theophylline alone is significantly higher than NAC alone and the combination.",2013,"Theophylline, NAC, and a combination of these drugs can decrease the rate of postoperative FEV1 compared to basal FEV1 significantly.","['patients with COPD who were candidates for off-pump coronary artery bypass graft (CABG) surgery', 'One hundred patients with COPD enrolled in this study as possible candidates for CABG surgery', '100 patients who had a smoking history of 27 pack years with a range of 20 to 40 pack years but were not heavy smokers and were candidates for elective off-pump CABG surgery in Afshar Cardiovascular Hospital, Yazd, Iran', 'chronic obstructive pulmonary disease (COPD', 'patients with a history of asthma and bronchospasm and non-COPD respiratory disorders', 'Of the participants, 83 (83.3%) were male and 17 (17%) were female', 'patients with COPD who are candidates for elective off-pump CABG surgery']","['theophylline and NAC together', 'theophylline', 'Theophylline', 'theophylline 10 mg/kg TDS', 'NAC', 'theophylline alone, N-acetylcysteine (NAC', 'Theophylline, NAC']","['pulmonary function', 'rate of postoperative FEV1', 'Stomach discomfort and cardiac complications', 'Rate of postoperative FEV1 to basal FEV1', 'rates of FEV1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1449706', 'cui_str': 'Coronary Artery Bypass, Off-Pump'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0455544', 'cui_str': 'H/O: asthma'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0172161', 'cui_str': 'tyramine-deoxysorbitol'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0235309', 'cui_str': 'Upset stomach (finding)'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",100.0,0.0771998,"Theophylline, NAC, and a combination of these drugs can decrease the rate of postoperative FEV1 compared to basal FEV1 significantly.","[{'ForeName': 'Seyed Jalil', 'Initials': 'SJ', 'LastName': 'Mirhosseini', 'Affiliation': 'Department of Cardiac Surgery, Yazd Cardiovascular Researches Center, Afshar Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyed Khalil', 'Initials': 'SK', 'LastName': 'Forouzannia', 'Affiliation': ''}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Nasirian', 'Affiliation': ''}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Ali-Hassan-Sayegh', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.114069']
2108,23956716,Comparison of the effects of remifentanil and alfentanil on intraocular pressure in cataract surgery.,"BACKGROUND
Anesthesia for ophthalmic surgery requires management of intraocular pressure (IOP) during perioperative period. In an open eye, in conditions such as after traumatic injury or during cataract surgery, IOP increase can lead to permanent vision loss. Administration of narcotics concomitant with anesthetics has the ability to reduce this increase of IOP. This clinical trial aims to compare the efficacy of remifentanil and alfentanil in preventing an increase in IOP after administration of succinylcholine, intubation and during anesthesia.
METHODS
This double-blind clinical trial was conducted on 50 patients undergoing elective general surgery for cataracts. Patients were randomly divided into two groups. Alfentanil (20 μg/kg in 30 s) for group 1 and remifentanil (1 μg/kg in 30 s) for group 2 were injected before induction of anesthesia, and 0.5 μg/kg/min alfentanil for group 1 and 0.1 μg/kg/min remifentanil for group 2 were infused during the anesthesia. Systolic and diastolic blood pressure, heart rate, and IOP from normal eye were measured before the induction, after administration of thiopental and succinylcholine, after tracheal intubation, and 2 min later, and were repeated in 2-min intervals until the end of operation.
RESULTS
IOP decreased after injection of anesthetics and remained lower all through the operation in both groups, but IOP decreased after injection of succinylcholine in remifentanil group while it increased in alfentanil group (P<0.05).
CONCLUSIONS
Results of this study indicate benefits of both remifentanil and alfentanil in managing IOP after induction and during anesthesia. It seems that remifentanil is better than alfentanil in controlling the IOP after injection of succinylcholine.",2013,"RESULTS
IOP decreased after injection of anesthetics and remained lower all through the operation in both groups, but IOP decreased after injection of succinylcholine in remifentanil group while it increased in alfentanil group (P<0.05).
","['50 patients undergoing elective general surgery for cataracts', 'cataract surgery']","['thiopental and succinylcholine', 'alfentanil', 'remifentanil and alfentanil', 'remifentanil', 'succinylcholine', 'Alfentanil', 'alfentanil for group 1 and 0.1 μg/kg/min remifentanil']","['IOP', 'Systolic and diastolic blood pressure, heart rate, and IOP from normal eye', 'permanent vision loss', 'intraocular pressure (IOP', 'intraocular pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",50.0,0.265812,"RESULTS
IOP decreased after injection of anesthetics and remained lower all through the operation in both groups, but IOP decreased after injection of succinylcholine in remifentanil group while it increased in alfentanil group (P<0.05).
","[{'ForeName': 'Godrat', 'Initials': 'G', 'LastName': 'Akhavanakbari', 'Affiliation': 'Department of Anesthesiology and Ophtalmology, Ardabil University of Medical Sciences, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Entezariasl', 'Affiliation': ''}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Ojagi', 'Affiliation': ''}, {'ForeName': 'Khatereh', 'Initials': 'K', 'LastName': 'Isazadehfar', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.114074']
2109,23956719,Induced hypotension for functional endoscopic sinus surgery: A comparative study of dexmedetomidine versus esmolol.,"OBJECTIVE
A comparative study to evaluate the efficacy of dexmedetomidine as a hypotensive agent in comparison to esmolol in Functional Endoscopic Sinus Surgery (FESS).
METHODS
Forty patients ASA I or II scheduled for FESS were equally randomly assigned to receive either dexmedetomidine 1 μg/Kg over 10 min before induction of anesthesia followed by 0.4-0.8 μg/Kg/h infusion during maintenance (DEX group), or esmolol, loading dose 1mg/kg was infused over one min followed by 0.4-0.8 mg/kg/h infusion during maintenance (E group) to maintain mean arterial blood pressure (MAP) between (55-65 mmHg). General anesthesia was maintained with sevoflurane 2%-4%. The surgical field was assessed using Average Category Scale and average blood loss was calculated. Hemodynamic variables (MAP and HR); arterial blood gas analysis; plasma cortisol level; intraoperative fentanyl consumption; Emergence time and total recovery from anesthesia (Aldrete score ≥9) were recorded. Sedation score was determined at 15, 30, 60 min after tracheal extubation and time to first analgesic request was recorded.
RESULT
Both DEX group and E group reached the desired MAP (55-65 mmHg) with no intergroup differences in MAP or HR. The for the quality of the surgical filed in the range of MAP (55-65 mmHg) were <=2 with no significant differences between group scores during hypotensive period. Mean intraoperative fentanyl consumption was significantly lower in DEX group than E group. Cortisol level showed no significant changes between or within groups. No significant changes were observed in arterial blood gases. Emergence time and time to achieve Aldrete score ≥9 were significantly lower in E group compared with DEX group. The sedation score were significantly lower in E group compared with DEX group at 15 and 30 minutes postoperatively. Time to first analgesic request was significantly longer in DEX group.
CONCLUSION
Both dexmedetomidine or esmolol with sevoflurane are safe agents for controlled hypotension and are effective in providing ideal surgical field during FESS. Compared with esmolol, dexmedetomidine offers the advantage of inherent analgesic, sedative and anesthetic sparing effect.",2013,Both DEX group and E group reached the desired MAP (55-65 mmHg) with no intergroup differences in MAP or HR.,"['Functional Endoscopic Sinus Surgery (FESS', 'functional endoscopic sinus surgery', 'Forty patients ASA I or II scheduled for FESS']","['esmolol', 'DEX', 'dexmedetomidine 1 μg/Kg over 10 min before induction of anesthesia followed by 0.4-0.8 μg/Kg/h infusion during maintenance (DEX group), or esmolol, loading dose 1mg/kg was infused over one min followed by 0.4-0.8 mg/kg/h infusion during maintenance (E group) to maintain mean arterial blood pressure (MAP', 'sevoflurane', 'esmolol, dexmedetomidine', 'dexmedetomidine']","['Hemodynamic variables (MAP and HR); arterial blood gas analysis; plasma cortisol level; intraoperative fentanyl consumption; Emergence time and total recovery from anesthesia (Aldrete score ≥9', 'Average Category Scale and average blood loss', 'Emergence time and time to achieve Aldrete score ≥9', 'Time to first analgesic request', 'Sedation score', 'arterial blood gases', 'Induced hypotension', 'sedation score', 'Mean intraoperative fentanyl consumption', 'Cortisol level']","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",40.0,0.0419209,Both DEX group and E group reached the desired MAP (55-65 mmHg) with no intergroup differences in MAP or HR.,"[{'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Shams', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Nahla S', 'Initials': 'NS', 'LastName': 'El Bahnasawe', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abu-Samra', 'Affiliation': ''}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'El-Masry', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.114073']
2110,23717223,Dexmedetomidine as anesthetic adjunct for fast tracking and pain control in off-pump coronary artery bypass.,"OBJECTIVE
This study was designed to determine the efficacy of dexmedetomidine (a highly selective alpha-2 agonist) in achieving fast tracking and improved postoperative pain control in off-pump coronary artery bypass (OPCAB) patients.
METHODS
THIRTY PATIENTS SCHEDULED FOR ELECTIVE OPCAB WERE PROSPECTIVELY RANDOMIZED INTO TWO GROUPS: Group I (15 patients) started dexmedetomidine at 0.5 ug/kg/hour after the induction of anesthesia; this was reduced to 0.3 ug/kg/hour on admission in the cardiac intensive care unit and continued for 12 hours post extubation. Group II (15 patients) received a similar volume and infusion rate of normal saline. Visual analog scale (VAS) of 10-100 was explained thoroughly to the patients during the preoperative visit. Postoperative pain was managed with morphine. The total dose of morphine was recorded. Extubation time and VAS was recorded every two hours for 12 hours post extubation.
RESULTS
Extubation time in group I was 72±8 minutes and 186±22 minutes in group II. Mean total use of narcotics in group II was 23.5±20.7 mg compared to 11.4±6.3 mg in group I. VAS median figures were lower at all data points in group I than in group II.
CONCLUSION
Dexmedetomidine showed an effective and safe profile as an anesthetic adjunct in OPCAB, achieving fast tracking of patients and higher quality of pain control with a lower consumption of narcotics.",2013,"RESULTS
Extubation time in group",['off-pump coronary artery bypass (OPCAB) patients'],"['morphine', 'normal saline', 'Dexmedetomidine', 'dexmedetomidine']","['Extubation time and VAS', 'Postoperative pain', 'effective and safe profile', 'Visual analog scale (VAS', 'postoperative pain control', 'Mean total use of narcotics']","[{'cui': 'C1449706', 'cui_str': 'Coronary Artery Bypass, Off-Pump'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}]",30.0,0.0215699,"RESULTS
Extubation time in group","[{'ForeName': 'Mohamed Essam', 'Initials': 'ME', 'LastName': 'Abdel-Meguid', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Ain Shams University, Egypt, King Fahad Specialist Hospital, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109557']
2111,23717224,Equal ratio ventilation (1:1) improves arterial oxygenation during laparoscopic bariatric surgery: A crossover study.,"BACKGROUND
Hypoxaemia and high peak airway pressure (Ppeak) are common anesthetic problems during laparoscopic bariatric surgery. Several publications have reported the successful improvement in arterial oxygenation using positive end expiratory pressure and alveolar recruitment maneuver, however, high peak airway pressure during laparoscopic bariatric surgery may limit the use of both techniques. This study was designed to determine whether equal I:E (inspiratory-to-expiratory) ratio ventilation (1:1) improves arterial oxygenation with parallel decrease in the Ppeak values.
METHODS
Thirty patients with a body mass index ≥40 kg/m(2) scheduled for laparoscopic bariatric surgery were randomized, after creation of pneumoperitoneum, to receive I:E ratio either 1:1 (group 1, 15 patients) or 1:2 (group 2, 15 patients). After a stabilization period of 30 min, patients were crossed over to the other studied I:E ratio. Ppeak, mean airway pressure (Pmean), dynamic compliance (Cdyn), arterial blood gases and hemodynamic data were collected at the end of each stabilization period.
RESULTS
VENTILATION WITH I: E ratio of 1:1 significantly increased partial pressure of O2 in the arterial blood (PaO2), Pmean and Cdyn with concomitant significant decrease in Ppeak compared to ventilation with I: E ratio of 1:2. There were no statistical differences between the two groups regarding the mean arterial pressure, heart rate, respiratory rate, end tidal CO2 or partial pressure of CO2 in the arterial blood.
CONCLUSION
Equal ratio ventilation (1:1) is an effective technique in increase PaO2 during laparoscopic bariatric surgery. It increases Pmean and Cdyn while decreasing Ppeak without adverse respiratory or hemodynamic effects.",2013,"There were no statistical differences between the two groups regarding the mean arterial pressure, heart rate, respiratory rate, end tidal CO2 or partial pressure of CO2 in the arterial blood.
",['Thirty patients with a body mass index ≥40 kg/m(2) scheduled for laparoscopic bariatric surgery'],"['laparoscopic bariatric surgery', 'Equal ratio ventilation', 'equal I:E (inspiratory-to-expiratory) ratio ventilation', 'pneumoperitoneum, to receive I']","['mean arterial pressure, heart rate, respiratory rate, end tidal CO2 or partial pressure of CO2 in the arterial blood', 'Ppeak, mean airway pressure (Pmean), dynamic compliance (Cdyn), arterial blood gases and hemodynamic data', 'arterial oxygenation', 'partial pressure of O2 in the arterial blood (PaO2), Pmean and Cdyn']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance (observable entity)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",30.0,0.0943694,"There were no statistical differences between the two groups regarding the mean arterial pressure, heart rate, respiratory rate, end tidal CO2 or partial pressure of CO2 in the arterial blood.
","[{'ForeName': 'Wesam Farid', 'Initials': 'WF', 'LastName': 'Mousa', 'Affiliation': 'Department of Anesthesia and Surgical ICU, College of Medicine, University of Dammam, Al Khobar, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109559']
2112,23717226,Randomized double blind trial of intraperitoneal instillation of bupivacaine and morphine for pain relief after laparoscopic gynecological surgeries.,"BACKGROUND
Intraperitoneal injection of anesthetic has been proposed to minimize postoperative pain after laparoscopic surgery. So a randomized, placebo-controlled study was conducted to compare the effectiveness of intraperitoneal bupivacaine with or without morphine for postoperative analgesia after laparoscopic gynecological surgeries.
METHODS
A total of 90 ASA I and II female patients scheduled for laparoscopic gynecological procedures were enrolled in the randomized double blind prospective study. The drug was injected intraperitoneally before the removal of trocar at the end of surgery. In group BM (n=30): 0.25% bupivacaine 30 ml + 2 mg morphine, in group BO (n=30) 30 ml 0.25% bupivacaine and in group C (n=30) 30 ml of saline was injected intraperitoneally. Postoperative quality of analgesia was assessed by VAS (0-100), for 24 hours and when VAS >40, rescue analgesic was administered. Total dose of rescue analgesia and side effects were noted.
RESULTS
INTRAPERITONEAL INSTILLATION OF BUPIVACAINE AND MORPHINE SIGNIFICANTLY REDUCES IMMEDIATE POSTOPERATIVE PAIN (VAS: 23.33±6.04 vs. 45.5±8.57). It also reduces pain at 4 hours after surgery in the BM group (VAS 24±12.13 vs. 41.17±7.27 in the BO group). The time of administration of first rescue analgesic was significantly higher in the BM group (6.15 hours) compared to the BO group (4.51 hours). The total dosage of rescue analgesic was more in the BO and C groups compared to the BM group.
CONCLUSION
Addition of morphine to local anesthetic significantly prolonged the time to first rescue analgesic requirement and the total consumption of rescue analgesic in 24 hours without any significant increase in adverse events.",2013,REDUCES IMMEDIATE POSTOPERATIVE PAIN (VAS: 23.33±6.04 vs. 45.5±8.57).,"['In group BM (n=30', 'A total of 90 ASA I and II female patients scheduled for laparoscopic gynecological procedures', 'after laparoscopic gynecological surgeries', 'postoperative analgesia after laparoscopic gynecological surgeries']","['morphine', 'intraperitoneal bupivacaine', 'placebo', 'saline', 'bupivacaine', 'bupivacaine and morphine']","['total dosage of rescue analgesic', 'pain', 'time of administration of first rescue analgesic', 'time to first rescue analgesic requirement and the total consumption of rescue analgesic', 'pain relief', 'adverse events', 'Postoperative quality of analgesia']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1327728'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",90.0,0.282172,REDUCES IMMEDIATE POSTOPERATIVE PAIN (VAS: 23.33±6.04 vs. 45.5±8.57).,"[{'ForeName': 'Bina P', 'Initials': 'BP', 'LastName': 'Butala', 'Affiliation': 'Department of Anaesthesia and Critical Care, Smt. K. M. Mehta and Smt. G. R. Doshi Institute of Kidney Diseases and Research Center, Dr. H. L. Trivedi Institute of Transplantation Sciences, Civil Hospital Campus, Asarwa, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Veena R', 'Initials': 'VR', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nived', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109800']
2113,23717233,Assessment of hemostatic changes after crystalloid and colloid fluid preloading in trauma patients using standard coagulation parameters and thromboelastography.,"BACKGROUND
The choice of an ideal fluid administered post trauma and its subsequent influence on coagulation still poses a clinical dilemma. Hence, this study was designed to assess the influence of in vivo hemodilution with various fluid preparations (4% gelatin, 6% hydoxyethyl starch (HES), Ringer's lactate, 0.9% normal saline) on coagulation using standard coagulation parameters and real-time thromboelastography (TEG) in patients undergoing elective surgery post trauma.
METHODS
In a randomized, double-blind study, 100 patients of either sex and age, belonging to ASA Grades I and II, scheduled for elective surgeries were allocated into four groups of 25 each according to the type of fluid infused. Group G (4% gelatin), Group N (0.9% normal saline), Group R (Ringer's lactate), and Group H (6% HES) received preloading with 1 L of fluid according to the group. The coagulation status of the patients was assessed during perioperative period (before surgery, after fluid preloading, and at the end of the surgery) using both conventional coagulation analysis and TEG.
STATISTICAL ANALYSIS
Analysis of variance (ANOVA), post hoc and Pearson Chi-square test were used.
RESULTS
In all the patients preloaded with gelatin, there was a significant increase in prothrombin time index (PTI; 14.88±0.90 vs. 13.78±3.01, P<0.001) and international normalized ratio (INR; 1.12±0.09 vs. 1.09±0.19, P<0.05) compared to the baseline value. An increase was observed in these parameters in the postoperative period also. In the HES group, there was statistically significant increase in PT time (15.70±1.51 vs. 13.74±0.75, P=0.01) and INR (1.20±0.15 vs. 1.03±0.17, P<0.001) as compared to the baseline. In the intergroup comparisons, the patients preloaded with HES had a significant increase in INR (1.20±0.15 vs. 1.12±0.09, P=0.04) and reaction time (R time; 6.84±2.55 min vs. 4.79±1.77 min, P=0.02) as compared to the gelatin group. The fall in coagulation time (k time; 2.16±0.98 vs. 3.94±2.6, P=0.02), rise in maximum amplitude (MA; 61.94±14.08 vs. 50.11±14.10, P=0.04), and rise in A20 (56.17±14.66 vs. 43.11±14.24, P=0.05) were more in patients preloaded with RL as compared to the HES group. 100% patients in the gelatin group, 84.2% patients in the NS group, 94.4% patients in the RL group, and 66.7% patients in the HES group had hypocoagulable (R time > 14 min) state in the postoperative period.
CONCLUSION
Crystalloids are optimal volume expanders in trauma, with RL having beneficial effects on coagulation system (decrease in k time and increase in MA and A20). Among the colloids, HES 6% (130/0.4) affects coagulation parameters (increase in PTI, INR, R time, k time) more than gelatin. Trial registration (protocol number-IEC/NP-189/2011).",2013,"In the HES group, there was statistically significant increase in PT time (15.70±1.51 vs. 13.74±0.75, P=0.01) and INR (1.20±0.15 vs. 1.03±0.17, P<0.001) as compared to the baseline.","['trauma patients using standard coagulation parameters and thromboelastography', 'patients undergoing elective surgery post trauma', 'I and II, scheduled for elective surgeries', '100 patients of either sex and age, belonging to ASA Grades']","['HES', ""vivo hemodilution with various fluid preparations (4% gelatin, 6% hydoxyethyl starch (HES), Ringer's lactate, 0.9% normal saline) on coagulation using standard coagulation parameters and real-time thromboelastography (TEG""]","['INR', 'hypocoagulable (R time', 'reaction time', 'PT time', 'rise in maximum amplitude', 'prothrombin time index', 'coagulation parameters', 'fall in coagulation time', 'coagulation system', 'PTI, INR, R time, k time', 'hemostatic changes']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0019009', 'cui_str': 'Hemodilution'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}]","[{'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0368930', 'cui_str': 'Clotting time'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0391072', 'cui_str': 'platinum (bis(acetato))(ethylenediamine) diiodide'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",100.0,0.0926736,"In the HES group, there was statistically significant increase in PT time (15.70±1.51 vs. 13.74±0.75, P=0.01) and INR (1.20±0.15 vs. 1.03±0.17, P<0.001) as compared to the baseline.","[{'ForeName': 'Chhavi', 'Initials': 'C', 'LastName': 'Sawhney', 'Affiliation': 'Department of Anaesthesia and Critical Care, JPNA Trauma Centre, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Arulselvi', 'Initials': 'A', 'LastName': 'Subramanian', 'Affiliation': ''}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Ajaz', 'Initials': 'A', 'LastName': 'Anjum', 'Affiliation': ''}, {'ForeName': 'Venencia', 'Initials': 'V', 'LastName': 'Albert', 'Affiliation': ''}, {'ForeName': 'Kapil Dev', 'Initials': 'KD', 'LastName': 'Soni', 'Affiliation': ''}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109809']
2114,23717235,Single-dose paravertebral blockade versus epidural blockade for pain relief after open renal surgery: A prospective randomized study.,"BACKGROUND
Paravertebral block (PVB) has been an established technique for providing analgesia to the chest and abdomen. We conducted the current study to compare single-dose PVB versus single-dose epidural blockade (EP) for pain relief after renal surgery.
METHODS
Eighty patients scheduled for renal surgery were randomly assigned into two groups according to the analgesic technique, PVB group or EP group. General anesthesia was induced for all patients. Postoperative pain was assessed over 24 h using 10-cm visual analog scale (VAS). Postoperative total pethidine consumption was recorded. Any postoperative events, such as nausea, vomiting, shivering, or respiratory complications, were recorded. Hemodynamics and blood gasometry were also recorded.
RESULTS
EP group showed significant decrease of both heart rate and mean blood pressure at most of the operative periods when compared with PVB group. There was no difference in total rescue analgesic consumption. Postoperative VAS showed no significant difference between the studied groups. Postoperative events were comparable in both the groups.
CONCLUSION
Single injection PVB resulted in similar analgesia but greater hemodynamic stability than epidural analgesia in patients undergoing renal surgery, therefore this technique may be recommended for patients with coexisting circulatory disease.",2013,"Single injection PVB resulted in similar analgesia but greater hemodynamic stability than epidural analgesia in patients undergoing renal surgery, therefore this technique may be recommended for patients with coexisting circulatory disease.","['Eighty patients scheduled for renal surgery', 'pain relief after renal surgery', 'after open renal surgery', 'patients undergoing renal surgery', 'patients with coexisting circulatory disease']","['Single-dose paravertebral blockade versus epidural blockade', 'analgesic technique, PVB group or EP', 'PVB versus single-dose epidural blockade (EP', 'Paravertebral block (PVB', 'epidural analgesia', 'Single injection PVB']","['hemodynamic stability', 'Postoperative pain', 'Postoperative VAS', 'Postoperative events', '10-cm visual analog scale (VAS', 'pain relief', 'nausea, vomiting, shivering, or respiratory complications', 'heart rate and mean blood pressure', 'Hemodynamics and blood gasometry', 'Postoperative total pethidine consumption', 'total rescue analgesic consumption']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation (procedure)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0005768'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",80.0,0.0547501,"Single injection PVB resulted in similar analgesia but greater hemodynamic stability than epidural analgesia in patients undergoing renal surgery, therefore this technique may be recommended for patients with coexisting circulatory disease.","[{'ForeName': 'Hazem Ebrahem', 'Initials': 'HE', 'LastName': 'Moawad', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Sherif Abdo', 'Initials': 'SA', 'LastName': 'Mousa', 'Affiliation': ''}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'El-Hefnawy', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109814']
2115,23717236,Granisetron versus tropisetron in the prevention of postoperative nausea and vomiting after total thyroidectomy.,"BACKGROUND
Postoperative nausea and vomiting (PONV) are frequently encountered after thyroidectomy. For PONV prevention, selective serotonin 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists are considered one of the first-line therapy. We report on the efficiency of granisetron and tropisetron, with that of placebo on the prevention of PONV in patients undergoing total thyroidectomy.
METHODS
One hundred twenty-seven patients were divided into three groups and randomized to receive intravenously, prior to induction of anesthesia, tropisetron 5 mg, or granisetron 3 mg, or normal saline. All patients received additionally 0.625 mg droperidol. All episodes of postoperative PONV during the first 24 h after surgery were evaluated.
RESULTS
Nausea visual analogue scale (VAS) score was lower in tropisetron and granisetron groups than the control group at all measurements (P<0.01) except for the 8-h measurement for tropisetron (P=0.075). Moreover, granisetron performed better than tropisetron (P<0.011 at 4 h and P<0.01 at all other points of time) apart from the 2-h measurement. Vomiting occurred in 22.2%, 27.5%, and 37.5% in granisetron, tropisetron, and control groups, respectively (P=0.43).
CONCLUSIONS
The combination of the 5-HT3 antagonists with droperidol given before induction of anesthesia is well tolerated and superior to droperidol alone in preventing nausea but not vomiting after total thyroidectomy.",2013,"Moreover, granisetron performed better than tropisetron (P<0.011 at 4 h and P<0.01 at all other points of time) apart from the 2-h measurement.","['patients undergoing total thyroidectomy', 'One hundred twenty-seven patients']","['droperidol', 'placebo', 'Granisetron', 'tropisetron', 'anesthesia, tropisetron 5 mg, or granisetron 3 mg, or normal saline', 'granisetron, tropisetron', 'granisetron', 'granisetron and tropisetron']","['Vomiting', 'postoperative PONV', 'Nausea visual analogue scale (VAS) score', 'postoperative nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319602', 'cui_str': '27'}]","[{'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1130306', 'cui_str': 'tropisetron 5 MG'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",127.0,0.0211398,"Moreover, granisetron performed better than tropisetron (P<0.011 at 4 h and P<0.01 at all other points of time) apart from the 2-h measurement.","[{'ForeName': 'Artemisia', 'Initials': 'A', 'LastName': 'Papadima', 'Affiliation': 'Department of Anesthesiology, Hippocrateion Hospital, Athens Medical School, University of Athens, Athens, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Gourgiotis', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Lagoudianakis', 'Affiliation': ''}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Pappas', 'Affiliation': ''}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Seretis', 'Affiliation': ''}, {'ForeName': 'Pantelis T', 'Initials': 'PT', 'LastName': 'Antonakis', 'Affiliation': ''}, {'ForeName': 'Haridimos', 'Initials': 'H', 'LastName': 'Markogiannakis', 'Affiliation': ''}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Makri', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Manouras', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109817']
2116,23717237,Clinical vs. bispectral index-guided propofol induction of anesthesia: A comparative study.,"BACKGROUND
Clinically optimized focusing of drug administration to specific need of patient with bispectral index (BIS) monitoring results in reduced dose and faster recovery of consciousness. This study was planned with an aim to study and compare the conventional clinical end point or BIS on the requirement of dosage of propofol, hemodynamic effects, and BIS alterations following propofol induction.
METHODS
70 patients, ASA I and II, 20-60 years undergoing elective surgical procedure under general anesthesia with endotracheal intubation were selected and divided into two groups. Group A received (inj.) fentanyl (2 μg/kg), followed 3 min later by inj. propofol at the rate of 30 mg/kg/hr infusion till the loss of response to verbal command while group B received inj. fentanyl (2 μg/kg), followed 3 min later by inj. propofol at the rate of 30 mg/kg/hr infusion. The end point of hypnosis was when the BIS value was sustained for 1 min at 48±2. The patients were intubated. Total induction dose of propofol was noted in each group. The value of BIS and hemodynamic parameters (heart rate, systolic/diastolic blood pressure) were noted at the time of loss of consciousness, at the time of intubation, and 1 min after intubation, thereafter every minute for first 10 min and thereafter every 10 min till end of surgery. Any involuntary muscle activity such as jerky movements, dystonic posturing, and opisthotonos were also recorded.
RESULTS
The mean dose of propofol used in groups A and B were 1.85±0.48 mg/kg and 1.79±0.41 mg/kg, respectively. The dosage used in group B were less but not clinically significant (P=0.575). On comparing the dosage of propofol in males among the groups there was a significantly lower dosage of propofol required in group B (2.06±0.45 mg/kg and 1.83±0.32 mg/kg, respectively, P=0.016). This decrease however was not seen in female patients dosage being 1.65±0.44 mg/kg and 1.75±0.49 mg/kg, respectively (P=0.372). The hemodynamic variables including heart rate, systolic/diastolic blood pressure and BIS were comparable within the group at induction, post-induction, and intubation. However, there was a significant increase in all the parameters at postintubation readings (P<0.001).
CONCLUSION
No significant difference in the induction dose of propofol was observed when assessed clinically (loss of verbal response) or by BIS monitoring. Traditional teaching to titrate the dose of propofol and depth of anesthesia during intubation by loss of verbal response is as good as BIS value monitoring.",2013,"On comparing the dosage of propofol in males among the groups there was a significantly lower dosage of propofol required in group B (2.06±0.45 mg/kg and 1.83±0.32 mg/kg, respectively, P=0.016).","['70 patients, ASA I and II, 20-60 years undergoing elective surgical procedure under general anesthesia with endotracheal intubation', 'anesthesia']","['propofol', 'propofol and depth of anesthesia', 'fentanyl']","['heart rate, systolic/diastolic blood pressure and BIS', 'value of BIS and hemodynamic parameters (heart rate, systolic/diastolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0474710', 'cui_str': 'Depth of anesthesia (observable entity)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",70.0,0.0259046,"On comparing the dosage of propofol in males among the groups there was a significantly lower dosage of propofol required in group B (2.06±0.45 mg/kg and 1.83±0.32 mg/kg, respectively, P=0.016).","[{'ForeName': 'Snehdeep', 'Initials': 'S', 'LastName': 'Arya', 'Affiliation': 'Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Asthana', 'Affiliation': ''}, {'ForeName': 'Jagdish P', 'Initials': 'JP', 'LastName': 'Sharma', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109819']
2117,23717225,Intraperitoneal hydrocortisone for pain relief after laparoscopic cholecystectomy.,"BACKGROUND
Laparoscopic cholecystectomy is associated with shorter hospital stay and less pain in comparison to open surgery. The aim of this study was to evaluate the effect of intraperitoneal hydrocortisone on pain relief following laparoscopic cholecystectomy.
METHODS
Sixty two patients were enrolled in a double-blind, randomized clinical trial. Patients randomly received intraperitoneal instillation of either 250 ml normal saline (n=31) or 100 mg hydrocortisone in 250 ml normal saline (n=31) before insufflation of CO2 into the peritoneum. Abdominal and shoulder pain were evaluated using VAS after surgery and at 6, 12, and 24 hours postoperatively. The patients were also followed for postoperative analgesic requirements, nausea and vomiting, and return of bowel function.
RESULTS
Sixty patients completed the study. Patients in the hydrocortisone group had significantly lower abdominal and shoulder pain scores (10.95 vs 12.95; P<0.01). The patients were similar regarding analgesic requirements in the recovery room. However, those in the hydrocortisone group required less meperidine than the saline group (151.66 (±49.9) mg vs 61.66 (±38.69) mg; P=0.00). The patients were similar with respect to return of bowel function, nausea and vomiting. No adverse reaction was observed in either group.
CONCLUSION
Intraperitoneal administration of hydrocortisone can significantly decrease pain and analgesic requirements after laparoscopic cholecystectomy with no adverse effects.",2013,"CONCLUSION
Intraperitoneal administration of hydrocortisone can significantly decrease pain and analgesic requirements after laparoscopic cholecystectomy with no adverse effects.","['Sixty two patients', 'after laparoscopic cholecystectomy', 'Sixty patients completed the study']","['Laparoscopic cholecystectomy', 'Intraperitoneal hydrocortisone', 'hydrocortisone in 250 ml normal saline', 'meperidine', 'hydrocortisone', 'intraperitoneal instillation of either 250 ml normal saline', 'intraperitoneal hydrocortisone']","['Abdominal and shoulder pain', 'abdominal and shoulder pain scores', 'pain and analgesic requirements', 'bowel function, nausea and vomiting', 'pain relief', 'adverse reaction', 'postoperative analgesic requirements, nausea and vomiting, and return of bowel function']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}]","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",62.0,0.249057,"CONCLUSION
Intraperitoneal administration of hydrocortisone can significantly decrease pain and analgesic requirements after laparoscopic cholecystectomy with no adverse effects.","[{'ForeName': 'Amene S', 'Initials': 'AS', 'LastName': 'Sarvestani', 'Affiliation': 'Department of Surgery, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Amini', 'Affiliation': ''}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Kalhor', 'Affiliation': ''}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Roshanravan', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Amir Hussein', 'Initials': 'AH', 'LastName': 'Lebaschi', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109799']
2118,23717227,A randomized controlled trial to compare fentanyl-propofol and ketamine-propofol combination for procedural sedation and analgesia in laparoscopic tubal ligation.,"BACKGROUND
Procedural sedation and analgesia is widely being used for female laparoscopic sterilization using combinations of different drugs at varying doses. This study compared the combination of fentanyl and propofol, and ketamine and propofol in patients undergoing outpatient laparoscopic tubal ligation, with respect to their hemodynamic effects, postoperative recovery characteristics, duration of hospital stay, adverse effects, and patient comfort and acceptability.
SETTINGS AND DESIGN
Randomized, double blind.
METHODS
Patients were assigned to receive premixed injection of either fentanyl 1.5 μg/kg + propofol 2 mg/kg (Group PF, n=50) or ketamine 0.5 mg/kg + propofol 2 mg/kg (Group PK, n=50). Hemodynamic data, peripheral oxygen saturation, and respiratory rate were recorded perioperatively. Recovery time, time to discharge, and comfort score were noted.
STATISTICAL ANALYSIS
Chi-square (χ(2)) test was used for categorical data. Student's t-test was used for quantitative variables for comparison between the two groups. For intragroup comparison, paired t-test was used. SPSS 14.0 was used for analysis.
RESULTS
Although the heart rate was comparable, blood pressures were consistently higher in group PK. Postoperative nausea and vomiting and delay in voiding were more frequent in group PK (P<0.05). The time to reach Aldrete score ≥8 was significantly longer in group PK (11.14±3.29 min in group PF vs. 17.3±6.32 min in group PK, P<0.01). The time to discharge was significantly longer in group PK (105.8±13.07 min in group PF vs.138.18±13.20 min in group PK, P<0.01). Patient comfort and acceptability was better in group PF, P<0.01).
CONCLUSION
As compared to ketamine-propofol, fentanyl-propofol combination is associated with faster recovery, earlier discharge, and better patient acceptability.",2013,"Patient comfort and acceptability was better in group PF, P<0.01).
","['laparoscopic tubal ligation', 'Patients', 'patients undergoing outpatient laparoscopic tubal ligation']","['ketamine-propofol, fentanyl-propofol combination', 'fentanyl-propofol and ketamine-propofol combination', 'fentanyl 1.5 μg/kg + propofol', 'fentanyl and propofol, and ketamine and propofol', 'ketamine 0.5 mg/kg + propofol']","['time to reach Aldrete score ≥8', 'Patient comfort and acceptability', 'blood pressures', 'hemodynamic effects, postoperative recovery characteristics, duration of hospital stay, adverse effects, and patient comfort and acceptability', 'heart rate', 'faster recovery, earlier discharge, and better patient acceptability', 'Recovery time, time to discharge, and comfort score', 'Hemodynamic data, peripheral oxygen saturation, and respiratory rate', 'time to discharge', 'Postoperative nausea and vomiting and delay in voiding']","[{'cui': 'C0520483', 'cui_str': 'Tubal Ligation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]",,0.173047,"Patient comfort and acceptability was better in group PF, P<0.01).
","[{'ForeName': 'Ranju', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Lady Hardinge Medical College and Shrimati Sucheta Kriplani Hospital, New Delhi, India.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Ghazanwy', 'Affiliation': ''}, {'ForeName': 'Homay', 'Initials': 'H', 'LastName': 'Vajifdar', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109801']
2119,23717228,Role of tranexamic acid in reducing postoperative blood loss and transfusion requirement in patients undergoing hip and femoral surgeries.,"CONTEXT
Pharmacological agents are used to reduce postoperative blood loss.
AIMS
To assess the effects of tranexamic acid on prevention of bleeding and requirement of blood transfusion after major hip and femoral surgeries.
SETTINGS AND DESIGN
A prospective, randomized, double blinded study was conducted in the tertiary care teaching hospital.
METHODS
Ninety ASA grade I-II patients undergoing hip fracture surgery were included in this prospective study. Forty-five patients received tranexamic acid (TA) given in a bolus dose of 500 mg 15 min before surgical incision followed by continuous infusion. The remaining, 45 patients were allocated as a control group. Postoperative bleeding (volume of blood in the drain), percentage fall of hemoglobin, transfusions and complications were recorded.
RESULTS
Mean volume of blood in the drain was 39.33±10.09 ml (mean±SD) as compared to 91.11±17.61 ml in placebo group showing a P<0.001. Mean percentage fall in Hb at day 0 was 2.99±3.45 in the study group as compared to 7.70±6.05 in the placebo group (P<0.001), and fall at day 2 in the study group was 0.35±0.74, compared to 2.72±2.70 in the placebo group (P<0.001). The number of patients required blood transfusions were lower in the study group than in the placebo group (P=0.01).
CONCLUSIONS
We conclude that tranexamic acid significantly reduces postoperative blood loss and transfusion requirements during major hip and femoral surgeries.",2013,"The number of patients required blood transfusions were lower in the study group than in the placebo group (P=0.01).
","['after major hip and femoral surgeries', 'I-II patients undergoing hip fracture surgery', 'Ninety ASA grade', 'patients undergoing hip and femoral surgeries', 'major hip and femoral surgeries']","['placebo', 'tranexamic acid', 'tranexamic acid (TA']","['Mean percentage fall in Hb', 'postoperative blood loss', 'postoperative blood loss and transfusion requirement', 'postoperative blood loss and transfusion requirements', 'prevention of bleeding and requirement of blood transfusion', 'Postoperative bleeding (volume of blood in the drain), percentage fall of hemoglobin, transfusions and complications', 'Mean volume of blood in the drain', 'number of patients required blood transfusions']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",45.0,0.369183,"The number of patients required blood transfusions were lower in the study group than in the placebo group (P=0.01).
","[{'ForeName': 'Bhavani S', 'Initials': 'BS', 'LastName': 'Vijay', 'Affiliation': 'Department of Anaesthesiology, Jawaharlal Nehru Medical College, A.M.U. Aligarh, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Bedi', 'Affiliation': ''}, {'ForeName': 'Subhro', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': ''}, {'ForeName': 'Bikramjit', 'Initials': 'B', 'LastName': 'Das', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109803']
2120,23717232,The analgesic efficacy of ultrasound-guided transversus abdominis plane block for retroperitoneoscopic donor nephrectomy: A randomized controlled study.,"BACKGROUND
Transversus abdominis plane (TAP) block is suitable for lower abdominal surgeries. Blind TAP block has many complications and uncertainty of its effects. Use of ultrasonography increases the safety and efficacy. This study was conducted to evaluate the analgesic efficacy of ultrasound (USG)-guided TAP block for retroperitoneoscopic donor nephrectomy (RDN).
METHODS
In a prospective randomized double-blind study, 60 patients undergoing laparoscopic donor nephrectomy were randomly divided into two groups by closed envelope method. At the end of surgery, USG-guided TAP block was given to the patients of both the groups. Study group (group S) received inj. Bupivacaine (0.375%), whereas control group (group C) received normal saline. Inj. Tramadol (1 mg/kg) was given as rescue analgesic at visual analog scale (VAS) more than 3 in any group at rest or on movement. The analgesic efficacy was judged by VAS both at rest and on movement, time tofirst dose of rescue analgesic, cumulative dose of tramadol, sedation score, and nausea score, which were also noted at 30 min, 2, 4, 6, 12, 18, and 24 h postoperatively. Total tramadol consumption at 24 h was also assessed.
RESULTS
Patients in group S had significantly lower VAS score, longer time tofirst dose of rescue analgesic (547.13±266.96 min vs. 49.17±24.95 min) and lower tramadol consumption (103.8±32.18 mg vs. 235.8±47.5 mg) in 24 h.
CONCLUSION
The USG-guided TAP block is easy to perform and effective as a postoperative analgesic regimen in RDN, with opioids-sparing effect and without any complications.",2013,"RESULTS
Patients in group S had significantly lower VAS score, longer time tofirst dose of rescue analgesic (547.13±266.96 min vs. 49.17±24.95 min) and lower tramadol consumption (103.8±32.18 mg vs. 235.8±47.5 mg) in 24 h.
CONCLUSION
",['60 patients undergoing'],"['retroperitoneoscopic donor nephrectomy (RDN', 'laparoscopic donor nephrectomy', 'normal saline', 'Transversus abdominis plane (TAP) block', 'ultrasound-guided transversus abdominis plane block', 'ultrasonography', 'Bupivacaine', 'ultrasound (USG)-guided TAP block', 'Tramadol', 'retroperitoneoscopic donor nephrectomy']","['Total tramadol consumption', 'rescue analgesic, cumulative dose of tramadol, sedation score, and nausea score', 'analgesic efficacy', 'VAS score, longer time tofirst dose of rescue analgesic', 'safety and efficacy', 'tramadol consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.150832,"RESULTS
Patients in group S had significantly lower VAS score, longer time tofirst dose of rescue analgesic (547.13±266.96 min vs. 49.17±24.95 min) and lower tramadol consumption (103.8±32.18 mg vs. 235.8±47.5 mg) in 24 h.
CONCLUSION
","[{'ForeName': 'Beena K', 'Initials': 'BK', 'LastName': 'Parikh', 'Affiliation': 'Department of Anaesthesia and Critical Care, Institute of Kidney Diseases and Research Centre, Civil Hospital Campus, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Vishal T', 'Initials': 'VT', 'LastName': 'Waghmare', 'Affiliation': ''}, {'ForeName': 'Veena R', 'Initials': 'VR', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Tanu', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Beena P', 'Initials': 'BP', 'LastName': 'Butala', 'Affiliation': ''}, {'ForeName': 'Geeta P', 'Initials': 'GP', 'LastName': 'Parikh', 'Affiliation': ''}, {'ForeName': 'Kalpana S', 'Initials': 'KS', 'LastName': 'Vora', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.109808']
2121,32421603,Efficacy and cost-effectiveness of intensive short-term dynamic psychotherapy for treatment resistant depression: 18-Month follow-up of the Halifax depression trial.,"BACKGROUND
Depressed patients with chronic and complex health issues commonly relapse; therefore, examining longer-term outcomes is an important consideration. For treatment resistant depression (TRD), the post-treatment efficacy of time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP) has been demonstrated but longer-term outcomes and cost-effectiveness are unclear.
METHOD
In this superiority trial, 60 patients referred to Community Mental Health Teams (CMHT) were randomised to 2 groups (ISTDP=30 and CMHT=30). The primary outcome was Hamilton Depression Rating scale (HAM-D) scores at 18 months. Secondary outcomes included Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission. A health economic evaluation examined mental health costs with quality-adjusted life years (QALYs).
RESULTS
Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up. Group differences in depression were in the moderate to large range on both the observer rated (Cohen's d = .64) and self-report measures (Cohen's d = .70). At 18 months follow-up the remission rate in ISTDP patients was 40.0%, and 23.4% had discontinued antidepressants. Health economic analysis suggests that ISTDP was more cost-effective than CMHT at 18 months. Probabilistic analysis suggests that there is a 64.5% probability of ISTDP being cost-effective at a willingness to pay for a QALY of $25,000 compared to CMHT at 18 months.
LIMITATIONS
Replication of these findings is necessary in larger samples and future cost analyses should also consider indirect costs.
CONCLUSIONS
ISTDP demonstrates long-term efficacy and cost-effectiveness in TRD.",2020,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,['60 patients referred to Community Mental Health Teams (CMHT'],"['ISTDP', 'intensive short-term dynamic psychotherapy', 'time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP']","['Hamilton Depression Rating scale (HAM-D) scores', 'Efficacy and cost-effectiveness', 'Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission', 'remission rate', 'depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",60.0,0.0697056,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,"[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Town', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada. Electronic address: joel.town@dal.ca.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stride', 'Affiliation': 'The Institute of Work Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry & Faculty of Computer Science, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernier', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berrigan', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.04.035']
2122,31365113,Effect of Enhanced Medical Rehabilitation on Functional Recovery in Older Adults Receiving Skilled Nursing Care After Acute Rehabilitation: A Randomized Clinical Trial.,"Importance
Enhanced medical rehabilitation (EMR) is a systematic and standardized approach for physical and occupational therapists to engage patients. Higher patient engagement in therapy might lead to improved functional recovery in rehabilitation settings, such as skilled nursing facilities (SNFs).
Objective
To determine whether EMR improves older adults' functional recovery.
Design, Setting, and Participants
A double-blind, parallel-group, randomized clinical trial was conducted from July 29, 2014, to July 13, 2018, in 229 adults aged 65 years or older admitted to 2 US SNFs. Participants were randomized to receive EMR (n = 114) vs standard-of-care rehabilitation (n = 115). Intention-to-treat analysis was used.
Interventions
The intervention group received their physical and occupational therapy from therapists trained in EMR. Based on models of motivation and behavior change, EMR is a toolkit of techniques to increase patient engagement and therapy intensity. The control group received standard-of-care rehabilitation from physical and occupational therapists not trained in EMR.
Main Outcomes and Measures
The primary outcome was change in function in activities of daily living and mobility, as assessed with the Barthel Index, which measures 10 basic activities of daily living or mobility items (scale range, 0-100), from SNF admission to discharge; secondary outcomes were gait speed for 10 m, 6-minute walk test, discharge disposition, rehospitalizations, and self-reported functional status at days 30, 60, and 90. To examine the rehabilitation process, therapists' engagement with patients and patient active time during therapy were measured for a sample of the sessions.
Results
Of the 229 participants, 149 (65.1%) were women; 177 (77.3%) were white, and 51 (22.3%) were black; mean (SD) age was 79.3 (8.0) years. Participants assigned to EMR showed greater recovery of function than those assigned to standard of care (mean increase in Barthel Index score, 35 points; 95% CI, 31.6-38.3 vs 28 points; 95% CI, 25.2-31.7 points; P = .007). There was no evidence of a difference in the length of stay (mean [SD], 23.5 [13.1] days). However, there were no group by time differences in secondary outcome measures, including self-reported function after SNF discharge out to 90 days as measured on the Barthel Index (mean [SE] score: EMR, 83.65 [2.20]; standard of care, 84.67 [2.16]; P = .96). The EMR therapists used a median (interquartile range) of 24.4 (21.0-37.3) motivational messages per therapy session vs 2.3 (1.1-2.9) for nontrained therapists (P < .001), and EMR patients were active during a mean (SD) of 52.5 (6.6%) of the therapy session time vs 41.2 (6.8%) for nontrained therapists (P = .001).
Conclusions and Relevance
Enhanced medical rehabilitation modestly improved short-term functional recovery for selected older adults rehabilitating in SNFs. However, there was no evidence that the benefits persisted over the longer term. This study demonstrates the value of engaging and motivating older adults in rehabilitation therapy, but more work is needed to extend these benefits to longer-term outcomes after discharge home.
Trial Registration
ClinicalTrials.gov identifier: NCT02114879.",2019,"Participants assigned to EMR showed greater recovery of function than those assigned to standard of care (mean increase in Barthel Index score, 35 points; 95% CI, 31.6-38.3 vs 28 points; 95% CI, 25.2-31.7 points; P = .007).","['229 participants, 149 (65.1%) were women; 177 (77.3%) were white, and 51 (22.3%) were black', 'n\u2009=\u2009114', 'selected older adults rehabilitating in SNFs', '229 adults aged 65 years or older admitted to 2 US SNFs', 'Older Adults Receiving Skilled Nursing Care']","['Importance\n\n\nEnhanced medical rehabilitation (EMR', 'physical and occupational therapy from therapists trained in EMR', 'EMR', 'standard-of-care rehabilitation from physical and occupational therapists not trained in EMR', 'EMR ', 'Enhanced Medical Rehabilitation']","['self-reported function after SNF discharge out to 90 days as measured on the Barthel Index', 'length of stay', 'change in function in activities of daily living and mobility, as assessed with the Barthel Index, which measures 10 basic activities of daily living or mobility items (scale range, 0-100), from SNF admission to discharge; secondary outcomes were gait speed for 10 m, 6-minute walk test, discharge disposition, rehospitalizations, and self-reported functional status', 'recovery of function']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",229.0,0.235244,"Participants assigned to EMR showed greater recovery of function than those assigned to standard of care (mean increase in Barthel Index score, 35 points; 95% CI, 31.6-38.3 vs 28 points; 95% CI, 25.2-31.7 points; P = .007).","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lenard', 'Affiliation': 'Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Marghuretta', 'Initials': 'M', 'LastName': 'Bland', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Barco', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yingling', 'Affiliation': 'Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Lang', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Morrow-Howell', 'Affiliation': 'Brown School of Social Work, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Baum', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Ellen F', 'Initials': 'EF', 'LastName': 'Binder', 'Affiliation': 'Division of Geriatrics and Nutritional Science, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Rodebaugh', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St Louis, St Louis, Missouri.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8199']
2123,32492883,EUS-Guided Versus Percutaneous Celiac Neurolysis for the Management of Intractable Pain Due to Unresectable Pancreatic Cancer: A Randomized Clinical Trial.,"Although endoscopic ultrasound-guided celiac neurolysis (EUS-CN) and percutaneous celiac neurolysis (PCN) are utilized to manage intractable pain in pancreatic cancer patients, no direct comparison has been made between the two methods. We compared the efficacy and safety of EUS-CN and PCN in managing intractable pain in such patients. Sixty pancreatic cancer patients with intractable pain were randomly assigned to EUS-CN ( n = 30) or PCN ( n = 30). The primary outcomes were pain reduction in numerical rating scale (NRS) and opioid requirement reduction. Secondary outcomes were: successful pain response (NRS decrease ≥50% or ≥3-point reduction from baseline); quality of life; patient satisfaction; adverse events; and survival rate at 3 months postintervention. Both groups reported sustained decreases in pain scores up to 3 months postintervention (mean reductions in abdominal pain: 0.9 (95% confidence interval (CI): -0.8 to 4.2) and 1.7 (95% CI: -0.3 to 2.1); back pain: 1.3 (95% CI: -0.9 to 3.4) and 2.5 (95% CI: -0.2 to 5.2) in EUS-CN, and PCN groups, respectively). The differences in mean pain scores between the two groups at baseline and 3 months were -0.5 ( p = 0.46) and -1.4 ( p = 0.11) for abdominal pain and 0.1 ( p = 0.85) and -0.9 ( p = 0.31) for back pain in favor of PCN. No significant differences were noted in opioid requirement reduction and other outcomes. EUS-CN and PCN were similarly effective and safe in managing intractable pain in pancreatic cancer patients. Either methods may be used depending on the resources and expertise of each institution.",2020,The differences in mean pain scores between the two groups at baseline and 3 months were -0.5 ( p = 0.46) and -1.4 ( p = 0.11) for abdominal pain and 0.1 ( p = 0.85) and -0.9 ( p = 0.31) for back pain in favor of PCN.,"['Intractable Pain Due to Unresectable Pancreatic Cancer', 'pancreatic cancer patients', 'Sixty pancreatic cancer patients with intractable pain']","['EUS-CN', 'PCN', 'EUS-CN and PCN', 'endoscopic ultrasound-guided celiac neurolysis (EUS-CN', 'percutaneous celiac neurolysis (PCN', 'EUS-Guided Versus Percutaneous Celiac Neurolysis']","['successful pain response (NRS decrease ≥50% or ≥3-point reduction from baseline); quality of life; patient satisfaction; adverse events; and survival rate', 'pain scores', 'pain reduction in numerical rating scale (NRS) and opioid requirement reduction', 'back pain', 'mean pain scores', 'opioid requirement reduction', 'abdominal pain']","[{'cui': 'C0030200', 'cui_str': 'Refractory Pain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0854776', 'cui_str': 'Pancreatic carcinoma non-resectable'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0196878', 'cui_str': 'Neurolysis'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",60.0,0.213644,The differences in mean pain scores between the two groups at baseline and 3 months were -0.5 ( p = 0.46) and -1.4 ( p = 0.11) for abdominal pain and 0.1 ( p = 0.85) and -0.9 ( p = 0.31) for back pain in favor of PCN.,"[{'ForeName': 'Won Jae', 'Initials': 'WJ', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul 07804, Korea.'}, {'ForeName': 'Yul', 'Initials': 'Y', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Changhoon', 'Initials': 'C', 'LastName': 'Yoo', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Sunguk', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Seong-Sik', 'Initials': 'SS', 'LastName': 'Cho', 'Affiliation': 'Department of Occupational and Environmental Medicine, College of Medicine, Dong-A University, Busan 49201, Korea.'}, {'ForeName': 'Jeong-Hun', 'Initials': 'JH', 'LastName': 'Suh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Seong-Soo', 'Initials': 'SS', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Do Hyun', 'Initials': 'DH', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9061666']
2124,23610743,Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin Versus Toxin-Naïve Subjects with Cervical Dystonia.,"BACKGROUND
To determine whether botulinum toxin treatment history affected the outcomes of a study comparing the safety and efficacy of incobotulinumtoxinA with placebo in subjects with cervical dystonia (CD).
METHODS
This was a prospective, double-blind, randomized, placebo-controlled, multicenter trial in botulinum toxin-treated or toxin-naïve CD subjects. Subjects received a fixed dose of either 120 U or 240 U of incobotulinumtoxinA or placebo. The primary outcome measure was change from baseline to Week 4 in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score. Treatment-emergent adverse events (TEAEs) were also evaluated. This report represents a subgroup analysis of botulinum toxin-treated or toxin-naïve subjects.
RESULTS
Participants (N = 233; 38.6% toxin-naïve) had a mean age of 52.8 years. IncobotulinumtoxinA significantly improved TWSTRS total scores from baseline to Week 4 in both dose groups versus placebo, and the improvement persisted through the end of the study (≤20 weeks). Both the previously toxin-treated and toxin-naïve subjects demonstrated significant improvements in TWSTRS total scores at Week 4 compared to baseline. The most frequent TEAEs in the incobotulinumtoxinA groups were dysphagia, neck pain, and muscular weakness, which were generally mild. TEAEs were more common in the 240 U group and toxin-naïve subjects.
DISCUSSION
Overall, incobotulinumtoxinA was safe and effective in CD, regardless of toxin therapy history. A lower starting dose may be better tolerated among toxin-naïve subjects without sacrificing efficacy.",2013,"IncobotulinumtoxinA significantly improved TWSTRS total scores from baseline to Week 4 in both dose groups versus placebo, and the improvement persisted through the end of the study (≤20 weeks).","['subjects with cervical dystonia (CD', 'Participants (N\u200a=\u200a233; 38.6% toxin-naïve) had a mean age of 52.8 years', 'Naïve Subjects with Cervical Dystonia', 'Subjects']","['Botulinum Toxin Versus Toxin', 'placebo', 'botulinum toxin-treated or toxin-naïve subjects', 'incobotulinumtoxinA', 'botulinum toxin-treated or toxin-naïve CD subjects', 'IncobotulinumtoxinA', 'incobotulinumtoxinA with placebo', 'incobotulinumtoxinA or placebo', 'botulinum toxin']","['Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score', 'TWSTRS total scores', 'Efficacy and Safety', 'dysphagia, neck pain, and muscular weakness']","[{'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}]","[{'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}]",,0.192697,"IncobotulinumtoxinA significantly improved TWSTRS total scores from baseline to Week 4 in both dose groups versus placebo, and the improvement persisted through the end of the study (≤20 weeks).","[{'ForeName': 'Hubert H', 'Initials': 'HH', 'LastName': 'Fernandez', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Pappert', 'Affiliation': ''}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Comella', 'Affiliation': ''}, {'ForeName': 'Virgilio Gerald H', 'Initials': 'VG', 'LastName': 'Evidente', 'Affiliation': ''}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Truong', 'Affiliation': ''}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jankovic', 'Affiliation': ''}]","Tremor and other hyperkinetic movements (New York, N.Y.)",['10.7916/D87P8X43']
2125,32421612,Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up.,"INTRODUCTION
Mindfulness-Based Cognitive Therapy (MBCT) has been shown to reduce depressive symptoms in patients with recurrent or chronic depression. However, sequential, follow-up interventions are needed to further improve outcome for this group of patients. One possibility is to cultivate mechanisms thought to support recovery from depression, such as (self-)compassion. The current study examined the efficacy of mindfulness-based compassionate living (MBCL) in recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up.
METHODS
Part one is a randomized controlled trial (RCT) comparing MBCL in addition to treatment as usual (TAU) with TAU alone. The primary outcome measure was severity of depressive symptoms. Possible mediators and moderators of treatment outcome were examined. Part two is an uncontrolled study of both intervention- and control group on the consolidation of treatment effect of MBCL over the course of a 6-months follow-up period.
RESULTS
Patients were recruited between July 2013 and December 2014 (N = 122). MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61). The results at 6-months follow-up showed a continued improvement of depressive symptoms.
LIMITATIONS
As MBCL was not compared with an active control condition, we have little information about the possible effectiveness of non-specific factors.
CONCLUSION
MBCL appears to be effective in reducing depressive symptoms in a population suffering from severe, prolonged, recurrent depressive symptoms. To optimise the (sequential) treatment trajectory, replication of the study in a prospective sequential trial is needed. Registered at ClinicalTrials.gov:NCT02059200.",2020,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","['patients with recurrent or chronic depression', 'recurrent depression', 'recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up', 'Patients were recruited between July 2013 and December 2014 (N\xa0=\xa0122']","['MBCL', 'TAU', 'mindfulness-based compassionate living (MBCL', 'intervention', 'Mindfulness-Based Cognitive Therapy (MBCT', 'mindfulness-based compassionate living compared with treatment-as-usual']","['depressive symptoms', 'severity of depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0570495,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","[{'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Schuling', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands. Electronic address: rhoda.schuling@radboudumc.nl.'}, {'ForeName': 'Marloes J', 'Initials': 'MJ', 'LastName': 'Huijbers', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Hiske', 'Initials': 'H', 'LastName': 'van Ravesteijn', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Health Technology Assessment, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.182']
2126,32492884,Short-Term Effects of PENS versus Dry Needling in Subjects with Unilateral Mechanical Neck Pain and Active Myofascial Trigger Points in Levator Scapulae Muscle: A Randomized Controlled Trial.,"Procedures such as dry needling (DN) or percutaneous electrical nerve stimulation (PENS) are commonly proposed for the treatment of myofascial trigger points (MTrP). The aim of the present study is to investigate if PENS is more effective than DN in the short term in subjects with mechanical neck pain. This was an evaluator-blinded randomized controlled trial. Subjects were recruited through announcements and randomly allocated into DN or PENS groups. Pain intensity, disability, pressure pain threshold (PPT), range of motion (ROM), and side-bending strength were measured. The analyses included mixed-model analyses of variance and pairwise comparisons with Bonferroni correction. The final sample was composed of 44 subjects (22 per group). Both groups showed improvements in pain intensity (η p 2 = 0.62; p < 0.01), disability (η p 2 = 0.74; p < 0.01), PPT (η p 2 = 0.79; p < 0.01), and strength (η p 2 = 0.37; p < 0.01). The PENS group showed greater improvements in disability (mean difference, 3.27; 95% CI, 0.27-6.27) and PPT (mean difference, 0.88-1.35; p < 0.01). Mixed results were obtained for ROM. PENS seems to produce greater improvements in PPT and disability in the short term.",2020,"Both groups showed improvements in pain intensity (η p 2 = 0.62; p < 0.01), disability (η p 2 = 0.74; p < 0.01), PPT (η p 2 = 0.79; p < 0.01), and strength (η p 2 = 0.37; p < 0.01).","['Subjects with Unilateral Mechanical Neck Pain and Active Myofascial Trigger Points in Levator Scapulae Muscle', 'subjects with mechanical neck pain']","['dry needling (DN) or percutaneous electrical nerve stimulation (PENS', 'PENS', 'PENS versus Dry Needling']","['strength', 'disability', 'pain intensity', 'PPT and disability', 'Pain intensity, disability, pressure pain threshold (PPT), range of motion (ROM), and side-bending strength']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0224368', 'cui_str': 'Structure of levator scapulae muscle'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",,0.141071,"Both groups showed improvements in pain intensity (η p 2 = 0.62; p < 0.01), disability (η p 2 = 0.74; p < 0.01), PPT (η p 2 = 0.79; p < 0.01), and strength (η p 2 = 0.37; p < 0.01).","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Garcia-de-Miguel', 'Affiliation': 'Physiotherapy and Pain Group, University of Alcalá, 28871 Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pecos-Martin', 'Affiliation': 'Physiotherapy and Pain Group, University of Alcalá, 28871 Madrid, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Larroca-Sanz', 'Affiliation': 'Department of Plastic and Restorative Surgery, University Hospital QuironSalud Madrid, 28223 Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Sanz-de-Vicente', 'Affiliation': 'Center of Sports Medicine of the Agencia Española de Protección de la Salud en el Deporte, 28040 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Garcia-Montes', 'Affiliation': 'Department of Physical Therapy, General University Hospital Gregorio Marañón, 28007 Madrid, Spain.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Fernandez-Matias', 'Affiliation': 'Research Institute of Physiotherapy and Pain, University of Alcala, 28805 Madrid, Spain.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Gallego-Izquierdo', 'Affiliation': 'Physiotherapy and Pain Group, University of Alcalá, 28871 Madrid, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9061665']
2127,31365099,Genetic Variation of the Vitamin D Binding Protein Affects Vitamin D Status and Response to Supplementation in Infants.,"CONTEXT
Single nucleotide polymorphisms (SNPs) of the vitamin D binding protein encoding the GC (group component) gene affect 25-hydroxyvitamin D (25OHD) concentrations, but their influence on vitamin D status and response to vitamin D supplementation in infants is unknown.
OBJECTIVE
To study GC genotype-related differences in 25OHD concentrations and the response to supplementation during a vitamin D intervention study in infants.
DESIGN
In this randomized controlled trial, healthy term infants received vitamin D3 (10 or 30 μg/d) from 2 weeks to 24 months of age. GC SNPs rs2282679, rs4588, rs7041, and rs1155563 were genotyped. rs4588/7041 diplotype and haplotypes of rs2282679, rs4588, and rs7041 (Haplo3SNP) and of all four SNPs (Haplo4SNP) were determined.
MAIN OUTCOME MEASURES
25OHD measured in cord blood at birth and at 12 and 24 months during intervention.
RESULTS
A total of 913 infants were included. Minor allele homozygosity of all studied GC SNPs, their combined haplotypes, and rs4588/rs7041 diplotype 2/2 were associated with lower 25OHD concentrations at all time points in one or both intervention groups [analysis of covariance (ANCOVA) P < 0.043], with the exception of rs7041, which did not affect 25OHD at birth. In the high-dose supplementation group receiving 30 μg/d vitamin D3, but not in those receiving 10 µg/d, genotype of rs2282679, rs4588, and rs7041; diplotype; and Haplo3SNP significantly affected intervention response (repeated measurement ANCOVA Pinteraction < 0.019). Minor allele homozygotes had lower 25OHD concentrations and smaller increases in 25OHD throughout the intervention.
CONCLUSIONS
In infants, vitamin D binding protein genotype affects 25OHD concentration and efficiency of high-dose vitamin D3 supplementation.",2019,"Minor allele homozygotes had lower 25OHD concentrations and smaller increase in 25OHD throughout intervention.
","['Altogether 913 infants were included', 'Infants', 'healthy term infants received 10 or 30 μg vitamin D3/day from 2 weeks to 24 months of age', 'infants']",['vitamin D supplementation'],"['25OHD measured in cord blood at birth', '25OHD concentrations', '25-hydroxyvitamin D (25OHD) concentrations']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",913.0,0.144209,"Minor allele homozygotes had lower 25OHD concentrations and smaller increase in 25OHD throughout intervention.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Enlund-Cerullo', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Koljonen', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Holmlund-Suila', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hauta-Alus', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rosendahl', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Valkama', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Helve', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Hytinantti', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Viljakainen', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Sture', 'Initials': 'S', 'LastName': 'Andersson', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Mäkitie', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Pekkinen', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00630']
2128,32427114,Use of the Healthy Lifestyle Coaching Chatbot App to Promote Stair-Climbing Habits Among Office Workers: Exploratory Randomized Controlled Trial.,"BACKGROUND
Lack of time for exercise is common among office workers given their busy lives. Because of occupational restrictions and difficulty in taking time off, it is necessary to suggest effective ways for workers to exercise regularly. Sustaining lifestyle habits that increase nonexercise activity in daily life can solve the issue of lack of exercise time. Healthy Lifestyle Coaching Chatbot is a messenger app based on the habit formation model that can be used as a tool to provide a health behavior intervention that emphasizes the importance of sustainability and involvement.
OBJECTIVE
This study aimed to assess the efficacy of the Healthy Lifestyle Coaching Chatbot intervention presented via a messenger app aimed at stair-climbing habit formation for office workers.
METHODS
From February 1, 2018, to April 30, 2018, a total of 106 people participated in the trial after online recruitment. Participants were randomly assigned to the intervention group (n=57) or the control group (n=49). The intervention group received cues and intrinsic and extrinsic rewards for the entire 12 weeks. However, the control group did not receive intrinsic rewards for the first 4 weeks and only received all rewards as in the intervention group from the fifth to twelfth week. The Self-Report Habit Index (SRHI) of participants was evaluated every week, and the level of physical activity was measured at the beginning and end of the trial. SPSS Statistics version 21 (IBM Corp) was used for statistical analysis.
RESULTS
After 4 weeks of intervention without providing the intrinsic rewards in the control group, the change in SRHI scores was 13.54 (SD 14.99) in the intervention group and 6.42 (SD 9.42) in the control group, indicating a significant difference between the groups (P=.04). When all rewards were given to both groups, from the fifth to twelfth week, the change in SRHI scores of the intervention and control groups was comparable at 12.08 (SD 10.87) and 15.88 (SD 13.29), respectively (P=.21). However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045).
CONCLUSIONS
This study provides evidence that intrinsic rewards are important to enhance the sustainability and effectiveness of an intervention. The Healthy Lifestyle Coaching Chatbot program can be a cost-effective method for healthy habit formation.
TRIAL REGISTRATION
Clinical Research Information Service KCT0004009; https://tinyurl.com/w4oo7md.",2020,"However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045).
","['Office Workers', 'office workers given their busy lives', 'From February 1, 2018, to April 30, 2018, a total of 106 people participated in the trial after online recruitment']","['Healthy Lifestyle Coaching Chatbot intervention', 'Healthy Lifestyle Coaching Chatbot App']","['Self-Report Habit Index (SRHI', 'level of physical activity', 'SRHI scores']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",106.0,0.0395995,"However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045).
","[{'ForeName': 'Meihua', 'Initials': 'M', 'LastName': 'Piao', 'Affiliation': 'Office of Hospital Information, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeongju', 'Initials': 'H', 'LastName': 'Ryu', 'Affiliation': 'College of Nursing, Seoul National University, Jongno-gu, Republic of Korea.'}, {'ForeName': 'Hyeongsuk', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College\xa0of\xa0Nursing, Gachon\xa0University, Incheon, Republic of Korea.'}, {'ForeName': 'Jeongeun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Seoul National University, Jongno-gu, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/15085']
2129,32492913,"Effects of Monomeric and Oligomeric Flavanols on Kidney Function, Inflammation and Oxidative Stress in Runners: A Randomized Double-Blind Pilot Study.","Nonsteroidal anti-inflammatory drugs are frequently used by athletes in order to prevent musculoskeletal pain and improve performance. In combination with strenuous exercise, they can contribute to a reduction of renal blood flow and promote development of kidney damage. We aimed to investigate whether monomeric and oligomeric flavanols (MOF) could reduce the severity of kidney injuries associated with the intake of 400-mg ibuprofen followed by the completion of a half-marathon in recreational athletes. In this double-blind, randomized study, the original MOF blend of extracts from grape seeds ( Vitis vinifera L.) and pine bark ( Pinus pinaster L.) or placebo were taken for 14 days preceding the ibuprofen/half-marathon. Urine samples were collected before and after the ibuprofen/half-marathon, and biomarkers of kidney injury, inflammation and oxidative stress were assessed. Intake of MOF significantly reduced the incidence of post-race hematuria ( p = 0.0004) and lowered concentrations of interleukin (IL)-6 in the urine ( p = 0.032). Urinary neutrophil-associated lipocalin, creatine, albumin, IL-8 and malondialdehyde tended to decrease. The supplementation with MOF in recreational runners appears to safely preserve kidney function, reduce inflammation and promote antioxidant defense during strenuous exercise and intake of a single dose of ibuprofen.",2020,"Urinary neutrophil-associated lipocalin, creatine, albumin, IL-8 and malondialdehyde tended to decrease.","['recreational runners', 'recreational athletes', 'Runners']","['strenuous exercise', 'monomeric and oligomeric flavanols (MOF', 'Monomeric and Oligomeric Flavanols', '400-mg ibuprofen', 'ibuprofen', 'placebo']","['Kidney Function, Inflammation and Oxidative Stress', 'incidence of post-race hematuria', 'Urinary neutrophil-associated lipocalin, creatine, albumin, IL-8 and malondialdehyde', 'lowered concentrations of interleukin (IL)-6', 'biomarkers of kidney injury, inflammation and oxidative stress', 'renal blood flow and promote development of kidney damage']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",,0.218245,"Urinary neutrophil-associated lipocalin, creatine, albumin, IL-8 and malondialdehyde tended to decrease.","[{'ForeName': 'Khrystyna O', 'Initials': 'KO', 'LastName': 'Semen', 'Affiliation': 'Campus Venlo, Faculty of Science and Engineering, Maastricht University, 5911 BV Venlo, The Netherlands.'}, {'ForeName': 'Antje R', 'Initials': 'AR', 'LastName': 'Weseler', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Health, Medicine, and Life Sciences, Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Marcel J W', 'Initials': 'MJW', 'LastName': 'Janssen', 'Affiliation': 'Department of Clinical Chemistry and Haematology, VieCuri Medical Center Noord Limburg, 5912 BL Venlo, The Netherlands.'}, {'ForeName': 'Marie-José', 'Initials': 'MJ', 'LastName': 'Drittij-Reijnders', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Health, Medicine, and Life Sciences, Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Jos L M L', 'Initials': 'JLML', 'LastName': 'le Noble', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Health, Medicine, and Life Sciences, Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Aalt', 'Initials': 'A', 'LastName': 'Bast', 'Affiliation': 'Campus Venlo, Faculty of Science and Engineering, Maastricht University, 5911 BV Venlo, The Netherlands.'}]",Nutrients,['10.3390/nu12061634']
2130,31998014,Ultrasound is a reliable and faster tool for confirmation of endotracheal intubation compared to chest auscultation and capnography when performed by novice anaesthesia residents - A prospective controlled clinical trial.,"Background
Anesthesia trainee may initially take longer time to intubate and unintentionally place the endotracheal tube (ETT) in the esophagus. The present study determined if ultrasound is the fastest method of confirmation of correct placement of ETT compared to capnography, and chest auscultation in trainees.
Methods
First year anesthesia residents performed intubation in 120 patients recruited after ethical clearance and informed consent. Time to visualize flutter in trachea, double trachea sign, time to appearance of first and sixth capnography, and time to execute chest auscultation was noted.
Results
Ultrasonography was statistically fastest method to determine endotracheal intubation (36.50 ± 15.14 seconds) vs unilateral chest auscultation (50.29 ± 15.50 seconds) vs bilateral chest auscultation (51.90 ± 15.98 seconds) vs capnography first waveform (53.57 ± 15.97 seconds) vs capnography sixth waveform (61.67 ± 15.88 seconds).
Conclusion
When teaching endotracheal intubation to novice anesthesia residents using conventional direct laryngoscopy, ultrasonography is the fastest method to confirm correct ETT placement compared to capnograph and chest auscultation. Mentor can guide trainee to direct ETT towards trachea and can promptly detect esophageal intubation by double trachea sign.",2020,"Results
Ultrasonography was statistically fastest method to determine endotracheal intubation (36.50 ± 15.14 seconds) vs unilateral chest auscultation (50.29 ± 15.50 seconds) vs bilateral chest auscultation (51.90 ± 15.98 seconds) vs capnography first waveform (53.57 ± 15.97 seconds)",['120 patients recruited after ethical clearance and informed consent'],[],"['Time to visualize flutter in trachea, double trachea sign, time to appearance of first and sixth capnography, and time to execute chest auscultation']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0040578', 'cui_str': 'Trachea'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0205440', 'cui_str': 'Sixth (qualifier value)'}, {'cui': 'C0376529', 'cui_str': 'Capnography'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]",120.0,0.042864,"Results
Ultrasonography was statistically fastest method to determine endotracheal intubation (36.50 ± 15.14 seconds) vs unilateral chest auscultation (50.29 ± 15.50 seconds) vs bilateral chest auscultation (51.90 ± 15.98 seconds) vs capnography first waveform (53.57 ± 15.97 seconds)","[{'ForeName': 'Apala Roy', 'Initials': 'AR', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Punj', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pandey', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Darlong', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bhoi', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_180_19']
2131,32427115,Mobile App to Improve House Officers' Adherence to Advanced Cardiac Life Support Guidelines: Quality Improvement Study.,"BACKGROUND
Effective and timely delivery of cardiac arrest interventions during in-hospital cardiac arrest resuscitation is associated with greater survival. Whether a mobile app that provides timely reminders of critical interventions improves adherence to Advanced Cardiovascular Life Support (ACLS) guidelines among house officers, who may lack experience in leading resuscitations, remains unknown.
OBJECTIVE
The aim of this study was to assess the impact of a commercially available, dynamic mobile app on house officers' adherence to ACLS guidelines.
METHODS
As part of a quality improvement initiative, internal medicine house officers were invited to participate and randomized to lead 2 consecutive cardiac arrest simulations, one with a novel mobile app and one without a novel mobile app. All simulations included 4 cycles of cardiopulmonary resuscitation with different cardiac arrest rhythms and were video recorded. The coprimary end points were chest compression fraction and number of correct interventions in each simulation. The secondary end point was incorrect interventions, defined as interventions not indicated by the 2015 ACLS guidelines. Paired t tests compared performance with and without the mobile app.
RESULTS
Among 53 house officers, 26 house officers were randomized to lead the first simulation with the mobile app, and 27 house officers were randomized to do so without the app. Use of the mobile app was associated with a higher number of correct ACLS interventions (out of 7; mean 6.2 vs 5.1; absolute difference 1.1 [95% CI 0.6 to 1.6]; P<.001) as well as fewer incorrect ACLS interventions (mean 0.3 vs 1.0; absolute difference -0.7 [95% CI -0.3 to -1.0]; P<.001). Simulations with the mobile app also had a marginally higher chest compression fraction (mean 90.9% vs 89.0%; absolute difference 1.9% [95% CI 0.6% to 3.4%]; P=.007).
CONCLUSIONS
This proof-of-concept study suggests that this novel mobile app may improve adherence to ACLS protocols, but its effectiveness on survival in real-world resuscitations remains unknown.",2020,"RESULTS
Among 53 house officers","['53 house officers', '26 house officers were randomized to lead the first simulation with the mobile app, and 27 house officers']",['novel mobile app and one without a novel mobile app'],"['higher number of correct ACLS interventions', 'chest compression fraction', 'incorrect ACLS interventions', 'chest compression fraction and number of correct interventions']","[{'cui': 'C0401975', 'cui_str': 'House officer'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",,0.123049,"RESULTS
Among 53 house officers","[{'ForeName': 'Vittal', 'Initials': 'V', 'LastName': 'Hejjaji', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Ali O', 'Initials': 'AO', 'LastName': 'Malik', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Poghni A', 'Initials': 'PA', 'LastName': 'Peri-Okonny', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Merrill', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wooldridge', 'Affiliation': 'Department of Internal Medicine, University of Missouri Kansas City, Kansas City, MO, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Chan', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}]",JMIR mHealth and uHealth,['10.2196/15762']
2132,23623526,Association of CYP2C19 polymorphisms and lansoprazole-associated respiratory adverse effects in children.,"OBJECTIVE
To determine whether cytochrome P450 (CYP)2C19 haplotype associates with lansoprazole-associated adverse event frequency.
STUDY DESIGN
Respiratory adverse events from a clinical trial of lansoprazole in children with asthma were analyzed for associations with extensive or poor metabolizer (PM) phenotype based on CYP2C19 haplotypes. Carriers of CYP2C19*2, *3, *8, or *9 alleles were PMs; carriers of 2 wild-type alleles were extensive metabolizers (EMs). Plasma concentrations of lansoprazole were determined in PM and EM phenotypes.
RESULTS
The frequency of upper respiratory infection among PMs (n = 45) was higher than that among EMs (n = 91), which in turn was higher than that in placebo subjects (n = 135; P = .0039). The frequency of sore throat (ST) was similarly distributed among EMs and PMs (P = .0015). The OR (95% CI) for upper respiratory infections in PMs was 2.46 (1.02-5.96) (P = .046); for EMs, the OR (95% CI) was 1.55 (0.86-2.79). The OR (95% CI) for ST in EMs and PMs was 2.94 (1.23-7.05, P = .016) vs 1.97 (1.09-3.55, P = .024), respectively. Mean ± SD plasma concentrations of lansoprazole were higher in PMs than in EMs: 207 ± 179 ng/mL vs 132 ± 141 ng/mL (P = .04).
CONCLUSIONS
Lansoprazole-associated upper respiratory infections and ST in children are related in part to CYP2C19 haplotype. Our data suggest that lansoprazole-associated adverse events in children may be mitigated by adjusting the conventional dose in PMs. Additional studies are required to replicate our findings.",2013,The frequency of sore throat (ST) was similarly distributed among EMs and PMs (P = .0015).,"['children', 'children with asthma were analyzed for associations with extensive or poor metabolizer (PM) phenotype based on CYP2C19 haplotypes']","['Lansoprazole', 'lansoprazole', 'CYP2C19']","['frequency of sore throat (ST', 'Mean ± SD plasma concentrations', 'adverse events', 'Plasma concentrations of lansoprazole', 'frequency of upper respiratory infection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}]","[{'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0732223', 'cui_str': 'SD plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",,0.0624398,The frequency of sore throat (ST) was similarly distributed among EMs and PMs (P = .0015).,"[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lima', 'Affiliation': ""Center for Pharmacogenomics and Translational Research, Nemours Children's Clinic, Jacksonville, FL, USA. jlima@nemours.org""}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Lang', 'Affiliation': ''}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Mougey', 'Affiliation': ''}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Blake', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': ''}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Teague', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2013.03.017']
2133,32492920,"Comparisons between Manual Lymph Drainage, Abdominal Massage, and Electrical Stimulation on Functional Constipation Outcomes: A Randomized, Controlled Trial.","BACKGROUND
Evidence supports abdominal massage (AM) or electrical stimulation (ES) as effective in treating functional constipation (FC). Manual lymph drainage (MLD) may also be beneficial, however, it was not previously investigated or compared to ES and AM.
METHODS
Sixteen college-aged males and 36 females were recruited. Participants were randomly assigned to MLD, AM or ES. Heart rate variability (HRV) measures for total power (TP), high frequency (HF), low frequency and LF/HF ratio assessed ANS outcomes. state-trait anxiety inventory (STAI) and stress response inventory (SRI) assessed psychological factors and bowel movement frequency (BMF) and duration (BMD) were recorded daily.
RESULTS
MLD significantly improved all ANS measures (p≤0.01); AM significantly improved LF, HF and LF/HF ratios (p = 0.04); and ES significantly improved LF (p = 0.1). STAI measures improved, but not significantly in all groups. SRI improved significantly from MLD (p < 0.01), AM (p = 0.04) and ES (p < 0.01), but changes were not significant between groups. BMD improved significantly in all groups (p≤ 0.02). BMF improved significantly only following MLD and AM (p < 0.1), but differences between groups were not significant (p = 0.39).
CONCLUSIONS
MLD significantly reduced FC symptoms and MLD had greater improvements than AM or ES.",2020,"RESULTS
MLD significantly improved all ANS measures (p≤0.01); AM significantly improved LF, HF and LF/HF ratios (p = 0.04); and ES significantly improved LF (p = 0.1).",['Sixteen college-aged males and 36 females were recruited'],"['Manual Lymph Drainage, Abdominal Massage, and Electrical Stimulation', 'MLD, AM or ES', 'Manual lymph drainage (MLD', 'abdominal massage (AM) or electrical stimulation (ES']","['SRI', 'Functional Constipation Outcomes', 'FC symptoms and MLD', 'BMF', 'Heart rate variability (HRV) measures for total power (TP), high frequency (HF), low frequency and LF/HF ratio assessed ANS outcomes', 'STAI measures', 'BMD', 'LF, HF and LF/HF ratios', 'state-trait anxiety inventory (STAI) and stress response inventory (SRI) assessed psychological factors and bowel movement frequency (BMF) and duration (BMD']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",36.0,0.135208,"RESULTS
MLD significantly improved all ANS measures (p≤0.01); AM significantly improved LF, HF and LF/HF ratios (p = 0.04); and ES significantly improved LF (p = 0.1).","[{'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'Drouin', 'Affiliation': 'School of Health Sciences, Oakland University, 433 Meadow Brook Road, Rochester, MI 48309-4451, USA.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Pfalzer', 'Affiliation': 'Physical Therapy Department, University of Michigan-Flint, 2157 WSW Bldg., Flint, MI 48502-195, USA.'}, {'ForeName': 'Jung Myo', 'Initials': 'JM', 'LastName': 'Shim', 'Affiliation': 'Department of Skin and Health Care, Suseong University, 15 Dalgubeol-daero 528-gil, Suseong-gu, Daegu 13557, Korea.'}, {'ForeName': 'Seong Jung', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Health and Science, Kangwon National University, 346, Hwangjo-gil, Dogye-eup, Samcheok-si, Gangwon-do 24341, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17113924']
2134,23493245,The comparison of Alfentanil and Remifentanil infusion during anesthesia on post-anesthesia recovery.,"BACKGROUND AND OBJECTIVE
With consideration the daily increased development of outpatient surgeries and high rate of these surgeries in elderly patients, rapid and safe recovery of patients is necessary. In this clinical trial study, recovery time and nausea and vomiting after the use of two rapid-onset narcotics, Alfentanil and Remifentanil, in elderly patients were evaluated.
METHODS
In this double-blind prospective clinical trial, 40 elderly patients (age above 65 years) candidate to cataract surgery with general anesthesia were studied. The patients were divided randomly into two groups and for first group, 10 μg/kg of Alfentanil was injected and for second group Remifentanil 0.5 μg/kg was injected intravenously during 30 seconds one minute before induction. Both two groups were under general anesthesia with same method and during the anesthesia, first group took infusion of Alfentanil 1 μg/kg/min and second group took Remifentanil 0.1 μg/kg/min. In the end of surgery, the time intervals between end of anesthesia drug administration and spontaneous respiration, eyes opening with stimulation, verbal response and discharge of recovery room, also the incidence of complications related to narcotic drugs, especially nausea and vomiting, was recorded. The data were analyzed in SPSS software using descriptive and analytical statistics such as T-test and chi square test.
RESULTS
The time of spontaneous respiration in Alfentanil group was 2 minutes and in Remifentanil group was 3.3 minutes, the difference was not statistically significant (P=0.08). The time of eyes opening with stimulation, verbal response, and discharge of recovery room were not significantly different. During recovery, incidence of nausea and vomiting in Remifentanil group (30% of patients) was significantly more than Alfentanil group (5% of patients) (P=0.045).
CONCLUSIONS
Recovery time between Alfentanil and Remifentanil group was not significantly different, but incidence of nausea and vomiting in Remifentanil group was higher than Alfentanil group significantly. It seems that using Alfentanil in the anesthesia for surgical treatment of the elderly people can be preferred.",2012,"During recovery, incidence of nausea and vomiting in Remifentanil group (30% of patients) was significantly more than Alfentanil group (5% of patients) (P=0.045).
","['elderly patients were evaluated', '40 elderly patients (age above 65 years) candidate to cataract surgery with general anesthesia were studied', 'elderly patients']","['Alfentanil 1 μg/kg/min and second group took Remifentanil', 'two rapid-onset narcotics, Alfentanil and Remifentanil', 'Alfentanil and Remifentanil', 'Alfentanil', 'Remifentanil']","['nausea and vomiting', 'spontaneous respiration, eyes opening with stimulation, verbal response and discharge of recovery room', 'time of spontaneous respiration', 'time of eyes opening with stimulation, verbal response, and discharge of recovery room', 'recovery time and nausea and vomiting']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",40.0,0.0667063,"During recovery, incidence of nausea and vomiting in Remifentanil group (30% of patients) was significantly more than Alfentanil group (5% of patients) (P=0.045).
","[{'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Entezariasl', 'Affiliation': 'Department of Anesthesiology, EDC Center, Ardabil University of Medical Sciences, Iran.'}, {'ForeName': 'Godrat', 'Initials': 'G', 'LastName': 'Akhavanakbari', 'Affiliation': ''}, {'ForeName': 'Khatereh', 'Initials': 'K', 'LastName': 'Isazadehfar', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105851']
2135,32493029,Dexmedetomidine aggravates hypotension following mesenteric traction during total gastrectomy: a randomized controlled trial.,"BACKGROUND
Mesenteric traction syndrome (MTS), which is characterized by arterial hypotension and tachycardia following mesenteric traction (MT), frequently occurs during abdominal surgery. Dexmedetomidine, commonly used in general anesthesia during major surgery, has a sympatholytic effect and attenuates the compensatory response to hypotension.
OBJECTIVE
Assess the effect of dexmedetomidine on hypotension following mesenteric traction.
DESIGN
Prospective, randomized, controlled clinical trial.
SETTING
Department of Anesthesiology, Zhenjiang First People's Hospital in China.
PATIENTS AND METHODS
Patients were randomly divided into three groups. Dexmedetomidine, 0.5 or 1.0 µg/kg, was intravenously administered over 15 minutes before skin incision followed by a maintenance rate of 0.5 µg/kg/h in groups D1 and D2, respectively; saline was administered in group C.
MAIN OUTCOME MEASURE(S)
The duration of hypotension, heart rate and plasma norepinephrine level in patients with MTS were recorded within 60 minutes following MT.
SAMPLE SIZE
75 patients.
RESULTS
The duration of hypotension in the MTS patients in group D1 and D2 was significantly longer than that in groups C (D1 vs. C, P <.05; D2 vs. C, P <.01). Significantly more phenylephrine was required to treat hypotension in group D1 and D2 than was required for patients in group C ( P <.05). The increase in heart rate during the first 15 minutes of MT in group D2 was significantly attenuated compared to that in group C ( P <.0083). The increases in norepinephrine levels during the first 15 minutes of MT in group C were significantly higher than those in groups D1 and D2 ( P <.0167).
CONCLUSION
Adjunctive dexmedetomidine in general anesthesia aggravates hypotension during MTS in open total gastrectomy.
LIMITATIONS
Postoperative complications were not evaluated.
CONFLICT OF INTEREST
None.",2020,"The increases in norepinephrine levels during the first 15 minutes of MT in group C were significantly higher than those in groups D1 and D2 ( P <.0167).
","['patients with MTS', 'Patients', 'aggravates hypotension following mesenteric traction during total gastrectomy', ""Department of Anesthesiology, Zhenjiang First People's Hospital in China"", 'general anesthesia aggravates hypotension during MTS in open total gastrectomy']","['Dexmedetomidine', 'dexmedetomidine', 'phenylephrine']","['treat hypotension', 'heart rate', 'duration of hypotension', 'duration of hypotension, heart rate and plasma norepinephrine level', 'norepinephrine levels', 'hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2747799', 'cui_str': 'Mesenteric traction syndrome'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025474', 'cui_str': 'Mesenteric'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1275472', 'cui_str': 'Plasma norepinephrine measurement'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",75.0,0.0582829,"The increases in norepinephrine levels during the first 15 minutes of MT in group C were significantly higher than those in groups D1 and D2 ( P <.0167).
","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""From the Department of Anesthesiology, Zhenjiang First People's Hospital, Zhenjiang, Jiangsu, China.""}, {'ForeName': 'Dong-Hua', 'Initials': 'DH', 'LastName': 'Shao', 'Affiliation': ""From the Department of Anesthesiology, Zhenjiang First People's Hospital, Zhenjiang, Jiangsu, China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Ma', 'Affiliation': ""From the Department of Anesthesiology, Zhenjiang First People's Hospital, Zhenjiang, Jiangsu, China.""}, {'ForeName': 'Zu-Min', 'Initials': 'ZM', 'LastName': 'Mao', 'Affiliation': ""From the Department of Anesthesiology, Zhenjiang First People's Hospital, Zhenjiang, Jiangsu, China.""}]",Annals of Saudi medicine,['10.5144/0256-4947.2020.183']
2136,23493460,The effects of warm and cold intrathecal bupivacaine on shivering during delivery under spinal anesthesia.,"BACKGROUND
Shivering associated with neuraxial anesthesia is a common problem that is uncomfortable for patients; it is of unknown ethnology and has no definite treatment.
PURPOSE
The purpose of this study was to compare the effects of warm intrathecal bupivacaine stored at 23°C and cold intrathecal bupivacaine stored at 4°C on shivering during delivery under spinal anesthesia.
METHODS
Seventy-eight parturient women scheduled for nonemergency cesarean delivery were enrolled in the study and separated into 2 groups. The standard group received 10 mg of heavy bupivacaine 0.5% stored at room temperature (23°C) plus 10 μg of fentanyl intrathecally (warm group), and the case group received 10 mg of heavy bupivacaine 0.5% stored at 4°C plus 10 μg of fentanyl intrathecally (cold group). Data collection, including sensory block level, blood pressure, core temperature, and shivering intensity, was first performed every minute for 10 min, then every 5 min for 35 min and, finally, every 10 min until the sensory level receded to L4.
RESULTS
There were no differences between the 2 groups in the amount of bleeding, pulse rate, oxygen saturation, neonatal Apgar, and incidence of vomiting. The incidence and intensity of shivering decreased in the warm group (P=0.002).
CONCLUSION
Warming of solutions can reduce the incidence and intensity of shivering in parturient candidates for cesarean delivery under spinal anesthesia.",2012,"There were no differences between the 2 groups in the amount of bleeding, pulse rate, oxygen saturation, neonatal Apgar, and incidence of vomiting.","['shivering during delivery under spinal anesthesia', 'parturient candidates for cesarean delivery under spinal anesthesia', 'Seventy-eight parturient women scheduled for nonemergency cesarean delivery were enrolled in the study and separated into 2 groups']","['warm intrathecal bupivacaine', 'heavy bupivacaine 0.5% stored at room temperature (23°C) plus 10 μg of fentanyl intrathecally (warm group), and the case group received 10 mg of heavy bupivacaine 0.5% stored at 4°C plus 10 μg of fentanyl intrathecally (cold group', 'warm and cold intrathecal bupivacaine', 'bupivacaine']","['incidence and intensity of shivering', 'sensory block level, blood pressure, core temperature, and shivering intensity', 'amount of bleeding, pulse rate, oxygen saturation, neonatal Apgar, and incidence of vomiting']","[{'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",78.0,0.0331794,"There were no differences between the 2 groups in the amount of bleeding, pulse rate, oxygen saturation, neonatal Apgar, and incidence of vomiting.","[{'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Najafianaraki', 'Affiliation': 'Department of Anesthesia, Bushehr Medical Science, Bushehr, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Mirzaei', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Macaire', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105854']
2137,23493723,Satisfaction level with topical versus peribulbar anesthesia experienced by same patient for phacoemulsification.,"BACKGROUND
Various studies have assessed patient satisfaction with topical versus peribulbar anesthesia with conflicting results. Aim of study was to determine satisfaction level in same patient who gets topical anesthesia in one eye and peribulbar block in another eye. We propose that evaluation of various indicators of patient satisfaction will enable better selection of cases for topical anesthesia in the future.
METHODS
Eighty patients scheduled for phacoemulsification were enrolled in prospective, randomized, double-blind study. Each patient scheduled twice for one eye under topical anesthesia and other in peribulbar block. Pain, discomfort and pressure during application of local anesthetic, during phacoemulsification and at 2 hours after procedure were assessed on standard scales. Before discharge patient satisfaction level was checked with Iowa satisfaction with anesthesia scale (ISAS). The Student's t-test was used to determine the significance of IOWA score in both groups. P<0.05 was considered significant.
RESULTS
Feeling of pain, pressure and discomfort scores during administration of topical anesthesia were all significantly lower compared to peribulbar anesthesia (P=0.004, 0.000, 0.002, respectively). In contrast, intraoperative scores were significantly higher in the topical anesthesia group compared to peribulbar anesthesia (P=0.022, 0.000, 0.000, respectively). Patient satisfaction measured with ISAS shows that peribulbar anesthesia with P=0.000 is strongly significant.
CONCLUSION
Peribulbar anesthesia provided significantly better patient satisfaction in comparison with topical anesthesia when used for cataract surgery.",2012,"RESULTS
Feeling of pain, pressure and discomfort scores during administration of topical anesthesia were all significantly lower compared to peribulbar anesthesia (P=0.004, 0.000, 0.002, respectively).","['Eighty patients scheduled for phacoemulsification', 'same patient who gets topical anesthesia in one eye and peribulbar block in another eye']","['topical anesthesia', 'peribulbar anesthesia']","['Feeling of pain, pressure and discomfort scores', 'IOWA score', 'satisfaction level', 'patient satisfaction', 'intraoperative scores', 'Satisfaction level', 'Iowa satisfaction with anesthesia scale (ISAS', 'Pain, discomfort and pressure']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0583006', 'cui_str': 'Peribulbar block'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0222045'}]",80.0,0.120883,"RESULTS
Feeling of pain, pressure and discomfort scores during administration of topical anesthesia were all significantly lower compared to peribulbar anesthesia (P=0.004, 0.000, 0.002, respectively).","[{'ForeName': 'Nauman', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': 'Department of Anesthesia, King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Zahoor', 'Affiliation': ''}, {'ForeName': 'Saeed A', 'Initials': 'SA', 'LastName': 'Motowa', 'Affiliation': ''}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Jastaneiah', 'Affiliation': ''}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Riad', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105866']
2138,32427113,A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness.,"BACKGROUND
The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated.
OBJECTIVE
This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored.
METHODS
This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement.
RESULTS
A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t 116 =2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI -7.423 to 6.301), and hemoglobin A 1c was 4.5 mmol/mol (95% CI -13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction.
CONCLUSIONS
Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care.
TRIAL REGISTRATION
International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.",2020,"Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37).","['patients with either or both hypertension and type 2 diabetes', 'nonadherent patients with either or both hypertension and type 2 diabetes', '135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years', 'Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting']","['control group that received usual care', 'highly tailored digital intervention', 'Tailored Text and Voice Messaging Intervention', 'highly tailored text message and interactive voice response intervention']","['Medication adherence', 'intentional nonadherence and nonintentional nonadherence', 'Systolic blood pressure and glucose levels', 'quality of life and mechanisms of behavior change', 'behavioral efficacy', 'Intervention fidelity, engagement, and satisfaction', 'Systolic blood pressure', 'Medication Adherence', 'high fidelity, engagement, and satisfaction', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}]",135.0,0.110415,"Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37).","[{'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Kassavou', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Mirzaei', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brimicombe', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Edwards', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Efthalia', 'Initials': 'E', 'LastName': 'Massou', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial College London, Cambridge, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Griffin', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}]",Journal of medical Internet research,['10.2196/16629']
2139,23493333,Preoperative C-reactive protein can predict early clinical outcomes following elective off-pump CABG surgery in patients with severe left ventricle dysfunction.,"PURPOSE
Atrial fibrillation (AF) is the most common type of arrhythmia following elective off-pump coronary bypass graft (CABG) surgery, occurring on the 2(nd) or 3(rd) postoperative day. Postoperative atrial fibrillation and early complications may be the cause of long term morbidity and mortality after hospital discharge. High sensitive C-reactive protein (hsCRP) seems to be most significantly associated with cardiovascular disorders. This study was designed to evaluate whether preoperative hsCRP (≥3 mg/dl) can predict post-elective off-pump CABG, AF, and early complications in patients with severe left ventricle dysfunction (Ejection Fraction (EF)<30%).
METHODS
This study was conducted on 104 patients with severe left ventriclar dysfunction (EF < 30%), undergoing elective off-pump CABG surgery during April to September 2011 at the Afshar Cardiovascular Center in Yazd, Iran. Patients undergoing emergency surgery and those with unstable angina, creatinine higher than 2.0 mg/dl, malignancy, or immunosuppressive disease were excluded from the study. The subjects were divided into two groups: Group I with preoperative increased hsCRP (>3 mg/dl) (n=51) and group N with preoperative normal hsCRP (<3 mg/dl) (n=53). We evaluated post-CABG variables including incidence, duration, and frequency of AF, early morbidity (bleeding, infection, vomiting, renal and respiratory dysfunctions), ICU or hospital stay and early mortality. Data were then analyzed by Analysis of Variance (ANOVA), Chi-square and Fisher exact test for quantitative and qualitative variables.
RESULTS
The average age of the patients was 62.5 years, 75 cases (72.1%) were male, and 39 (37.5%) were female. Postoperative AF occurred in 19 cases (18.2%); 17 cases (33.3%) had hsCRP≥3 mg/dl and 2 cases (3.8%) had hsCRP≤3 mg/dl (P=0.03). Postoperative midsternotomy infection, respiratory dysfunction, and hospital stay were significantly higher in group I compared with group N (P<0.05). No statistical significant differences were identified between the two groups concerning other postoperative complications (bleeding, vomiting, renal dysfunction and ICU stay) (P>0.05).
CONCLUSION
Preoperative hsCRP ≥3 mg/dl can predict incidence of postoperative atrial fibrillation and early complications such as midsternotomy infection, respiratory dysfunction, and hospital stay following elective off-pump CABG.",2012,"No statistical significant differences were identified between the two groups concerning other postoperative complications (bleeding, vomiting, renal dysfunction and ICU stay) (P>0.05).
","['The average age of the patients was 62.5 years, 75 cases (72.1%) were male, and 39 (37.5%) were female', 'Patients undergoing emergency surgery and those with unstable angina, creatinine higher than 2.0 mg/dl, malignancy, or immunosuppressive disease were excluded from the study', 'patients with severe left ventricle dysfunction (Ejection Fraction (EF)<30', '104 patients with severe left ventriclar dysfunction (EF < 30%), undergoing elective off-pump CABG surgery during April to September 2011 at the Afshar Cardiovascular Center in Yazd, Iran', 'patients with severe left ventricle dysfunction']","['elective off-pump CABG surgery', 'preoperative hsCRP (≥3 mg/dl', 'High sensitive C-reactive protein (hsCRP', 'preoperative increased hsCRP', 'preoperative normal hsCRP', 'Preoperative C-reactive protein']","['Postoperative midsternotomy infection, respiratory dysfunction, and hospital stay', 'Postoperative AF', 'incidence, duration, and frequency of AF, early morbidity (bleeding, infection, vomiting, renal and respiratory dysfunctions), ICU or hospital stay and early mortality', 'postoperative atrial fibrillation and early complications such as midsternotomy infection, respiratory dysfunction, and hospital stay', 'postoperative complications (bleeding, vomiting, renal dysfunction and ICU stay', 'Postoperative atrial fibrillation and early complications']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0151578', 'cui_str': 'Creatinine increased'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018827', 'cui_str': 'Heart Ventricle'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing (finding)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0231243', 'cui_str': 'Early complication (finding)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",104.0,0.0229036,"No statistical significant differences were identified between the two groups concerning other postoperative complications (bleeding, vomiting, renal dysfunction and ICU stay) (P>0.05).
","[{'ForeName': 'Seyed Jalil', 'Initials': 'SJ', 'LastName': 'Mirhosseini', 'Affiliation': 'Department of Cardiac Surgery, Yazd Cardiovascular Research Center, Yazd, Iran.'}, {'ForeName': 'Seyed Khalil', 'Initials': 'SK', 'LastName': 'Forouzannia', 'Affiliation': ''}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Ali-Hassan-Sayegh', 'Affiliation': ''}, {'ForeName': 'Hamidreza Varasteh', 'Initials': 'HV', 'LastName': 'Ravan', 'Affiliation': ''}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Abdollahi', 'Affiliation': ''}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mozayan', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105852']
2140,23493523,The evaluation of efficacy and safety of paravertebral block for perioperative analgesia in patients undergoing laparoscopic cholecystectomy.,"BACKGROUND
Paravertebral block is a popular regional anesthetic technique used for perioperative analgesia in multiple surgical procedures. There are very few randomized trials of its use in laparoscopic cholecystectomy in medical literature. This study was aimed at assessing its efficacy and opioid-sparing potential in this surgery.
METHODS
FIFTY PATIENTS WERE INCLUDED IN THIS PROSPECTIVE RANDOMIZED STUDY AND ALLOCATED TO TWO GROUPS: Group A (25 patients) receiving general anesthesia alone and Group B (25 patients) receiving nerve-stimulator-guided bilateral thoracic Paravertebral Block (PVB) at T6 level with 0.3 ml/kg of 0.25% bupivacaine prior to induction of general anesthesia. Intraoperative analgesia was supplemented with fentanyl (0.5 μg/kg) based on hemodynamic and clinical parameters. Postoperatively, patients in both the groups received Patient-Controlled Analgesia (PCA) morphine for the first 24 hours. The efficacy of PVB was assessed by comparing intraoperative fentanyl requirements, postoperative VAS scores at rest, and on coughing and PCA morphine consumption between the two groups.
RESULTS
Intraoperative supplemental fentanyl was significantly less in Group B compared to Group A (17.6 μg and 38.6 μg, respectively, P =0.001). PCA morphine requirement was significantly low in the PVB group at 2, 6, 12, and 24 hours postoperatively compared to that in Group A (4.4 mg vs 6.9 mg, 7.6 mg vs 14.2 mg, 11.6 mg vs 20.0 mg, 16.8 mg vs 27.2 mg, respectively; P <0.0001 at all intervals).
CONCLUSION
Pre-induction PVB resulted in improved analgesia for 24 hours following laparoscopic cholecystectomy in this study, along with a significant reduction in perioperative opioid consumption and opioid-related side effects.",2012,"PCA morphine requirement was significantly low in the PVB group at 2, 6, 12, and 24 hours postoperatively compared to that in Group A (4.4 mg vs 6.9 mg, 7.6 mg vs 14.2 mg, 11.6 mg vs 20.0 mg, 16.8 mg vs 27.2 mg, respectively; P <0.0001 at all intervals).
CONCLUSION
Pre-induction PVB resulted in improved analgesia for 24 hours following laparoscopic cholecystectomy in this study, along with a significant reduction in perioperative opioid consumption and opioid-related side effects.",['patients undergoing laparoscopic cholecystectomy'],"['laparoscopic cholecystectomy', 'paravertebral block', 'fentanyl', 'general anesthesia alone and Group B (25 patients) receiving nerve-stimulator-guided bilateral thoracic Paravertebral Block (PVB) at T6 level with 0.3 ml/kg of 0.25% bupivacaine', 'Patient-Controlled Analgesia (PCA) morphine']","['PCA morphine requirement', 'efficacy of PVB', 'perioperative opioid consumption and opioid-related side effects', 'intraoperative fentanyl requirements, postoperative VAS scores at rest, and on coughing and PCA morphine consumption', 'analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582124', 'cui_str': 'Neurostimulator, device (physical object)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",50.0,0.0548193,"PCA morphine requirement was significantly low in the PVB group at 2, 6, 12, and 24 hours postoperatively compared to that in Group A (4.4 mg vs 6.9 mg, 7.6 mg vs 14.2 mg, 11.6 mg vs 20.0 mg, 16.8 mg vs 27.2 mg, respectively; P <0.0001 at all intervals).
CONCLUSION
Pre-induction PVB resulted in improved analgesia for 24 hours following laparoscopic cholecystectomy in this study, along with a significant reduction in perioperative opioid consumption and opioid-related side effects.","[{'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Ravinder K', 'Initials': 'RK', 'LastName': 'Batra', 'Affiliation': ''}, {'ForeName': 'Anjolie', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': ''}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Subramaniam', 'Affiliation': ''}, {'ForeName': 'Mahesh C', 'Initials': 'MC', 'LastName': 'Misra', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105860']
2141,23493430,Airtraq™ versus Macintoch laryngoscope in intubation performance in the pediatric population.,"PURPOSE
Airtraq™ is an optical laryngoscope that allows viewing of the vocal cords without a direct line of sight. The main objective of this prospective, randomized, controlled trial was to evaluate Airtraq intubation characteristics, mainly intubation time and cardiovascular changes in the pediatric patients.
METHODS
Fifty children of American Society of Anesthesiologists class I, 2-10 years of age were divided into 2 groups using sealed envelope technique. Children were premedicated with midazolam. Anesthesia was induced with sevoflurane, fentanyl, and atracurium. Patients were randomly allocated to be intubated with either Airtraq (Airtraq group) or Macintosh laryngoscope (Macintosh group). Intubation time, number of intubation attempts, optimization maneuvers, and ease of intubation were recorded. Hemodynamic variables were recorded before and after anesthetic induction, 1, 3, and 5 min after tracheal intubation.
RESULTS
The mean age of children was 6.1 years. Compared with Macintosh group, the use of Airtraq was associated with shorter intubation time (51.6±26.7 s vs 22.8±6.1 s, respectively, P=0.001), less median number of intubation attempts 2 (1-2) versus 1 (1-1), P=0.001), more ease of intubation [2 (1-3) versus 1 (1-1), P=0.001] and less increase in the heart rate 5 min after intubation (P=0.007). No optimization maneuvers required for Airtraq laryngoscope (P=0.001).
CONCLUSION
Airtraq decreases intubation time, number of attempts, and optimization maneuvers, less heart rate changes during intubation compared with Macintosh laryngoscope.",2012,"Airtraq decreases intubation time, number of attempts, and optimization maneuvers, less heart rate changes during intubation compared with Macintosh laryngoscope.","['pediatric patients', 'pediatric population', 'Fifty children of American Society of Anesthesiologists class']","['sevoflurane, fentanyl, and atracurium', 'Airtraq (Airtraq group) or Macintosh laryngoscope (Macintosh group', 'midazolam', 'Airtraq™ versus Macintoch laryngoscope']","['ease of intubation', 'heart rate', 'Hemodynamic variables', 'Airtraq intubation characteristics, mainly intubation time and cardiovascular changes', 'median number of intubation attempts', 'shorter intubation time', 'Intubation time, number of intubation attempts, optimization maneuvers, and ease of intubation', 'intubation time, number of attempts, and optimization maneuvers, less heart rate changes']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}]",50.0,0.117075,"Airtraq decreases intubation time, number of attempts, and optimization maneuvers, less heart rate changes during intubation compared with Macintosh laryngoscope.","[{'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Riad', 'Affiliation': 'Department of Anesthesia, Toronto Western Hospital, 399 Bathurst Street, McL 2 405 Toronto, ON, Canada M5T 2SB, Canada.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moussa', 'Affiliation': ''}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Wong', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105853']
2142,23493806,Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks versus caudal block for postoperative analgesia in children undergoing unilateral groin surgery.,"CONTEXT
Ultrasound (US) guidance is strongly recommended when performing peripheral nerve blocks in infants and children.
AIMS
To assess whether US-guided ilioinguinal/iliohypogastric (II/IH) nerve blocks with local anesthetic (LA) would provide comparable postoperative analgesia to blind technique caudal block with LA following pediatric unilateral groin surgery. Secondary endpoints included analgesic consumption, parental satisfaction, and postoperative complications.
SETTINGS AND DESIGN
Prospective, crossover randomized controlled trial performed on children undergoing unilateral groin surgery.
METHODS
Fifty children aged 1-6 years scheduled for unilateral groin surgery were included in the study. After induction of general anesthesia and prior to surgical incision, patients were prospectively randomized into one of two groups: Group B received US-guided II/IH nerve blocks with 0.1 ml.kg(-1) of 0.25% bupivacaine and Group C received a caudal blockade with 0.7 ml.kg(-1) of 0.25% bupivacaine. Patients were assessed in the recovery room, the day-stay unit and for 24 h at home for pain score, analgesic consumption, and parental satisfaction.
STATISTICAL ANALYSIS
Arithmetic mean and standard deviation values were calculated and statistical analyses were performed for each group. Independent sample t-test was used to compare continuous variables exhibiting normal distribution, and Chi-squared test or Fisher exact test for non-continuous variables. P<0.05 was considered significant.
RESULTS
The average pain scores during hospital stay were 1.82±1.71and 1.52±1.41 for group C and group B respectively (P>0.05). The average time to first rescue analgesia was longer in group B 253±102.6 min as compared to 219.6±48.4 min in group C. In recovery room, four patients in group C required pain rescue medication compared to five patients in group B (P>0.05). Similarly eight patients in the group C and six patients in group B required pain rescue medication at day-stay unit or at home (P>0.05). Group C received 0.74 pain rescue medication doses (range 0-8), while group B received 0.65 pain rescue medication doses (range 0-6) at hospital and at home (P>0.05).
CONCLUSIONS
US-guided II/IH nerve blocks is an ideal postoperative analgesic for unilateral groin surgery in children, particularly hernia repairs and is as effective as caudal block, with a lower volume of local anesthetics.",2012,The average pain scores during hospital stay were 1.82±1.71and 1.52±1.41 for group C and group B respectively (P>0.05).,"['infants and children', 'children undergoing unilateral groin surgery', 'Fifty children aged 1-6 years scheduled for unilateral groin surgery were included in the study', 'pediatric unilateral groin surgery']","['caudal blockade with 0.7 ml.kg(-1) of 0.25% bupivacaine', 'general anesthesia and prior to surgical incision', 'US-guided II/IH nerve blocks with 0.1 ml.kg(-1) of 0.25% bupivacaine', 'Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks versus caudal block', 'US-guided II', 'US-guided ilioinguinal/iliohypogastric (II/IH) nerve blocks with local anesthetic (LA']","['average pain scores during hospital stay', 'pain rescue medication', 'average time to first rescue analgesia', 'Arithmetic mean and standard deviation values', 'pain score, analgesic consumption, and parental satisfaction', 'analgesic consumption, parental satisfaction, and postoperative complications']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0394767', 'cui_str': 'Local anesthetic block of iliohypogastric nerve (procedure)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",50.0,0.134625,The average pain scores during hospital stay were 1.82±1.71and 1.52±1.41 for group C and group B respectively (P>0.05).,"[{'ForeName': 'Abualhassan A', 'Initials': 'AA', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Menoufiya University, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105868']
2143,23493852,Combined general-epidural anesthesia with continuous postoperative epidural analgesia preserves sigmoid colon perfusion in elective infrarenal aortic aneurysm repair.,"BACKGROUND
In elective open infrarenal aortic aneurysm repair the use of epidural anesthesia and analgesia may preserve splanchnic perfusion. The aim of this study was to investigate the effects of epidural anesthesia on gut perfusion with gastrointestinal tonometry in patients undergoing aortic reconstructive surgery.
METHODS
THIRTY PATIENTS, SCHEDULED TO UNDERGO AN ELECTIVE INFRARENAL ABDOMINAL AORTIC RECONSTRUCTIVE PROCEDURE WERE RANDOMIZED IN TWO GROUPS: the epidural anesthesia group (Group A, n=16) and the control group (Group B, n=14). After induction of anesthesia, a transanally inserted sigmoid tonometer was placed for the measurement of sigmoid and gastric intramucosal CO2 levels and the calculation of regional-arterial CO2 difference (ΔPCO2). Additional measurements included mean arterial pressure (MAP), cardiac output (CO), systemic vascular resistance (SVR), and arterial lactate levels.
RESULTS
There were no significant intra- and inter-group differences for MAP, CO, SVR, and arterial lactate levels. Sigmoid pH and PCO2 increased in both the groups, but this increase was significantly higher in Group B, 20 min after aortic clamping and 10 min after aortic declamping.
CONCLUSIONS
Patients receiving epidural anesthesia during abdominal aortic reconstruction appear to have less severe disturbances of sigmoid perfusion compared with patients not receiving epidural anesthesia. Further studies are needed to verify these results.",2012,"Sigmoid pH and PCO2 increased in both the groups, but this increase was significantly higher in Group B, 20 min after aortic clamping and 10 min after aortic declamping.
","['patients undergoing aortic reconstructive surgery', 'elective infrarenal aortic aneurysm repair']","['epidural anesthesia and analgesia', 'gastrointestinal tonometry', 'epidural anesthesia']","['severe disturbances of sigmoid perfusion', 'Sigmoid pH and PCO2', 'MAP, CO, SVR, and arterial lactate levels', 'sigmoid and gastric intramucosal CO2 levels and the calculation of regional-arterial CO2 difference (ΔPCO2', 'mean arterial pressure (MAP), cardiac output (CO), systemic vascular resistance (SVR), and arterial lactate levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0397942', 'cui_str': 'Aortic aneurysm repair (procedure)'}]","[{'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0391839', 'cui_str': 'PCO2'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}]",30.0,0.0256609,"Sigmoid pH and PCO2 increased in both the groups, but this increase was significantly higher in Group B, 20 min after aortic clamping and 10 min after aortic declamping.
","[{'ForeName': 'Venetiana', 'Initials': 'V', 'LastName': 'Panaretou', 'Affiliation': 'Department of Anesthesiology, ""Hippokration"", Vascular Surgery Unit, University of Athens Medical School, ""Hippokration"" Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Siafaka', 'Affiliation': ''}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Theodorou', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Manouras', 'Affiliation': ''}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Seretis', 'Affiliation': ''}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Gourgiotis', 'Affiliation': ''}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Katsaragakis', 'Affiliation': ''}, {'ForeName': 'Fragiska', 'Initials': 'F', 'LastName': 'Sigala', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zografos', 'Affiliation': ''}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Filis', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105870']
2144,23484573,Comparison of Nintendo Wii and PlayStation2 for enhancing laparoscopic skills.,"BACKGROUND AND OBJECTIVE
The increase in laparoscopic surgery has led to a growing need to train residents in this skill. Virtual reality simulators and box trainers have been used as educational tools outside of the operating room, but both approaches have advantages and disadvantages. Video games have been an area of interest in the search for other modalities to train residents. Experience with the traditional single controller unit video games have been correlated with better surgical skill acquisition. In 2006, Nintendo introduced the Wii, a novel gaming modality that mimics movements in laparoscopy better than traditional games do. Our objective was to compare the Nintendo Wii and PlayStation2 for enhancing laparoscopy skills.
METHODS
The study included stratified randomization of 23 less experienced ( 12 laparoscopy cases per year) and 19 more experienced ( 12 per year) physicians, residents, and medical students to 30 min of Wii versus PlayStation2 in a university-affiliated hospital Department of Obstetrics and Gynecology. Pre- and posttest bead transfer and suturing scores were obtained.
RESULTS
Baseline characteristics were similar for both video game groups. Participants assigned to Wii and PlayStation2 both demonstrated significant improvement in bead transfer. Neither Wii nor PlayStation2 participants improved in suturing scores. The Wii group improved more in bead transfer scores when compared to the PlayStation2 group (60 points vs. 40 points, respectively), but this difference was not statistically significant.
CONCLUSIONS
Both Wii and PlayStation2 significantly improved laparoscopic skills in bead transfer. These video games may be inexpensive alternatives to laparoscopy training simulators.",2012,"The Wii group improved more in bead transfer scores when compared to the PlayStation2 group (60 points vs. 40 points, respectively), but this difference was not statistically significant.
","['23 less experienced ( 12 laparoscopy cases per year) and 19 more experienced ( 12 per year) physicians, residents, and medical students to 30 min of Wii versus PlayStation2 in a university-affiliated hospital Department of Obstetrics and Gynecology']","['Video games', 'Nintendo Wii and PlayStation2', 'Virtual reality simulators and box trainers']","['laparoscopic skills', 'Pre- and posttest bead transfer and suturing scores', 'bead transfer scores', 'surgical skill acquisition', 'bead transfer', 'suturing scores']","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0019961', 'cui_str': 'Hospital Departments'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.0704876,"The Wii group improved more in bead transfer scores when compared to the PlayStation2 group (60 points vs. 40 points, respectively), but this difference was not statistically significant.
","[{'ForeName': 'Rujin', 'Initials': 'R', 'LastName': 'Ju', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of North Carolina, Chapel Hill, NC 27514, USA. Rujin_ju@med.unc.edu'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Buckley', 'Affiliation': ''}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Wang', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680812X13462882737294']
2145,23492881,Caudal block and emergence delirium in pediatric patients: Is it analgesia or sedation?,"BACKGROUND
Emergence delirium (ED) although a short-lived and self-limiting phenomenon, makes a child prone to injury in the immediate postoperative period and hence is a cause of concern not only to the pediatric anesthesiologist, surgeons, and post anesthesia care unit staff but also amongst parents. Additional medication to quieten the child offsets the potential benefits of rapid emergence and delays recovery in day care settings. There is conflicting evidence of influence of analgesia and sedation following anesthesia on emergence agitation. We hypothesized that an anesthetic technique which improves analgesia and prolongs emergence time will reduce the incidence of ED. We selected ketamine as adjuvant to caudal block for this purpose.
METHODS
This randomized, double blind prospective study was performed in 150 premedicated children ASA I, II, aged 2 to 8 years who were randomly assigned to either group B (caudal with bupivacaine), BK (bupivacaine and ketamine), or NC (no caudal), soon after LMA placement. Recovery characteristics and complications were recorded.
RESULTS
Emergence time, duration of pain relief, and Pediatric Anesthesia Emergence Delirium (PAED) scores were significantly higher in the NC group (P<0.05). Duration of analgesia and emergence time were significantly more in group BK than groups B and NC. However, the discharge readiness was comparable between all groups. No patient in BK group required to be given any medication to treat ED.
CONCLUSION
Emergence time as well as duration of analgesia have significant influence on incidence of emergence delirium. Ketamine, as caudal adjuvant is a promising agent to protect against ED in children, following sevoflurane anesthesia.",2012,Duration of analgesia and emergence time were significantly more in group BK than groups B and NC.,"['pediatric patients', '150 premedicated children ASA I, II, aged 2 to 8 years']","['bupivacaine), BK (bupivacaine and ketamine), or NC (no caudal), soon after LMA placement', 'Ketamine', 'ketamine', 'sevoflurane anesthesia']","['Emergence time, duration of pain relief, and Pediatric Anesthesia Emergence Delirium (PAED) scores', 'Duration of analgesia and emergence time', 'discharge readiness']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",150.0,0.232241,Duration of analgesia and emergence time were significantly more in group BK than groups B and NC.,"[{'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Consultant Anesthesiologist, Pain and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Sood', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105887']
2146,23493938,Effect of sevoflurane versus propofol-based anesthesia on the hemodynamic response and recovery characteristics in patients undergoing microlaryngeal surgery.,"BACKGROUND
This randomized study was conducted to compare the hemodynamic changes and emergence characteristics of sevoflurane versus propofol anesthesia for microlaryngeal surgery.
METHODS
Forty adult patients undergoing microlaryngoscopy were randomly allocated into two groups. In propofol group, anesthesia was induced with 2-3 mg/kg propofol and maintained with propofol infusion 50-200 μg/kg/h. In sevoflurane group induction was carried out with 5-8% sevoflurane and maintained with sevoflurane in nitrous oxide and oxygen. The propofol and sevoflurane concentrations were adjusted to maintain the bispectral index of 40-60. All patients received fentanyl 2 μg/kg before induction and succinylcholine 2 mg/kg to facilitate tracheal intubation. The hemodynamic changes during induction and suspension laryngoscopy were compared. In addition, the emergence time, time to extubation, and recovery were assessed.
RESULTS
The changes in heart rate were comparable. The mean arterial pressure was significantly lower after induction and higher at insertion of operating laryngoscope in propofol group as compared to sevoflurane group. More patients in propofol group had episodes of hypotension and hypertension than sevoflurane group. The emergence time, extubation times, and recovery time were similar in both groups.
CONCLUSION
We found that sevoflurane showed advantage over propofol in respect of intraoperative cardiovascular stability without increasing recovery time.",2012,The mean arterial pressure was significantly lower after induction and higher at insertion of operating laryngoscope in propofol group as compared to sevoflurane group.,"['Forty adult patients undergoing microlaryngoscopy', 'patients undergoing microlaryngeal surgery']","['nitrous oxide and oxygen', 'fentanyl 2 μg/kg before induction and succinylcholine 2 mg/kg to facilitate tracheal intubation', 'propofol-based anesthesia', 'propofol and sevoflurane', 'propofol', 'propofol anesthesia', 'sevoflurane', 'propofol and maintained with propofol']","['emergence time, time to extubation, and recovery', 'heart rate', 'mean arterial pressure', 'emergence time, extubation times, and recovery time', 'intraoperative cardiovascular stability', 'hemodynamic response and recovery characteristics', 'episodes of hypotension and hypertension']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456202', 'cui_str': 'Microlaryngoscopy (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",40.0,0.107228,The mean arterial pressure was significantly lower after induction and higher at insertion of operating laryngoscope in propofol group as compared to sevoflurane group.,"[{'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bharti', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Promila', 'Initials': 'P', 'LastName': 'Chari', 'Affiliation': ''}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.105876']
2147,32492942,"Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients with Acute Myocardial Infarction: A Randomized, Placebo-Controlled EPISODE Trial.","BACKGROUND
Endothelial progenitor cells (EPCs) have the potential to protect against atherothrombotic event occurrences. There are no data to evaluate the impact of cilostazol on EPC levels in high-risk patients.
METHODS
We conducted a randomized, double-blind, placebo-controlled trial to assess the effect of adjunctive cilostazol on EPC mobilization and platelet reactivity in patients with acute myocardial infarction (AMI). Before discharge, patients undergoing percutaneous coronary intervention (PCI) were randomly assigned to receive cilostazol SR capsule (200-mg) a day ( n = 30) or placebo ( n = 30) on top of dual antiplatelet therapy (DAPT) with clopidogrel and aspirin. Before randomization (baseline) and at 30-day follow-up, circulating EPC levels were analyzed using flow cytometry and hemostatic measurements were evaluated by VerifyNow and thromboelastography assays. The primary endpoint was the relative change in EPC levels between baseline and 30-day.
RESULTS
At baseline, there were similar levels of EPC counts between treatments, whereas patients with cilostazol showed higher levels of EPC counts compared with placebo after 30 days. Cilostazol versus placebo treatment displayed significantly higher changes in EPC levels between baseline and follow-up (ΔCD133 + /KDR + : difference 216%, 95% confidence interval (CI) 44~388%, p = 0.015; ΔCD34 + /KDR + : difference 183%, 95% CI 25~342%, p = 0.024). At 30-day follow-up, platelet reactivity was lower in the cilostazol group compared with the placebo group (130 ± 45 versus 169 ± 62 P2Y12 Reaction Unit, p = 0.009). However, there were no significant correlations between the changes of EPC levels and platelet reactivity.
CONCLUSION
Adjunctive cilostazol on top of clopidogrel and aspirin versus DAPT alone is associated with increased EPC mobilization and decreased platelet reactivity in AMI patients, suggesting its pleiotropic effects against atherothrombotic events (NCT04407312).",2020,"At 30-day follow-up, platelet reactivity was lower in the cilostazol group compared with the placebo group (130 ± 45 versus 169 ± 62 P2Y12 Reaction Unit, p = 0.009).","['patients undergoing percutaneous coronary intervention (PCI', 'Patients with Acute Myocardial Infarction', 'patients with acute myocardial infarction (AMI']","['Adjunctive Cilostazol', 'adjunctive cilostazol', 'dual antiplatelet therapy (DAPT) with clopidogrel and aspirin', 'Placebo', 'clopidogrel and aspirin versus DAPT', 'cilostazol', 'Endothelial progenitor cells (EPCs', 'cilostazol SR capsule', 'Cilostazol versus placebo', 'placebo']","['EPC levels and platelet reactivity', 'platelet reactivity', 'relative change in EPC levels', 'EPC mobilization and platelet reactivity', 'EPC mobilization', 'circulating EPC levels', 'EPC levels', 'EPC counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.682286,"At 30-day follow-up, platelet reactivity was lower in the cilostazol group compared with the placebo group (130 ± 45 versus 169 ± 62 P2Y12 Reaction Unit, p = 0.009).","[{'ForeName': 'Yongwhi', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Gyeongsang National University, Jinju 52828, Korea.'}, {'ForeName': 'Jin Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Institute of the Health Sciences, Gyeongsang National University, Jinju 52727, Korea.'}, {'ForeName': 'Tae Ho', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Biomedical Research Institute, Gyeongsang National University Hospital, Jinju52727, Korea.'}, {'ForeName': 'Jin-Sin', 'Initials': 'JS', 'LastName': 'Koh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Gyeongsang National University, Jinju 52828, Korea.'}, {'ForeName': 'Seok-Jae', 'Initials': 'SJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Gyeongsang National University, Jinju 52828, Korea.'}, {'ForeName': 'Jin-Yong', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Gyeongsang National University, Jinju 52828, Korea.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Gyeongsang National University, Jinju 52828, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9061678']
2148,32427280,Thyroid function in neonates conceived after hysterosalpingography with iodinated contrast.,"STUDY QUESTION
Does exposure to preconceptional hysterosalpingography (HSG) with iodinated oil-based contrast affect neonatal thyroid function as compared to iodinated water-based contrast?
SUMMARY ANSWER
Preconceptional HSG with iodinated contrast did not influence the neonatal thyroid function.
WHAT IS KNOWN ALREADY
HSG is a commonly applied tubal patency test during fertility work-up in which either oil- or water-based contrast is used. Oil-based contrast contains more iodine compared to water-based contrast. A previous study in an East Asian population found an increased risk of congenital hypothyroidism (CH) in neonates whose mothers were exposed to high amounts of oil-based contrast during HSG.
STUDY DESIGN, SIZE, DURATION
This is a retrospective data analysis of the H2Oil study, a randomized controlled trial (RCT) comparing HSG with the use of oil- versus water-based contrast during fertility work-up. After an HSG with oil-based contrast, 214 women had an ongoing pregnancy within 6 months leading to a live birth compared to 155 women after HSG with water-based contrast.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Of the 369 women who had a live born infant, 208 consented to be approached for future research and 138 provided informed consent to collect data on the thyroid function tests of their offspring (n = 140). Thyroid function tests of these children were retrieved from the Dutch neonatal screening program, which includes the assessment of total thyroxine (T4) in all newborns, followed by thyroid-stimulating hormone only in those with a T4 level of ≤ -0.8 SD score. Furthermore, amount of contrast medium used and time between HSG and conception were compared between the two study groups.
MAIN RESULTS AND THE ROLE OF CHANCE
Data were collected from 140 neonates conceived after HSG with oil-based (n = 76) or water-based (n = 64) contrast. The median T4 concentration was 87.0 nmol/l [76.0-96.0] in the oil group and 90.0 nmol/l [78.0-106.0] in the water group (P = 0.13). None of the neonates had a positive screening result for CH.The median amount of contrast medium used was 9.0 ml [interquartile range (IQR), 6.0-11.8] in the oil-group and 10.0 ml [IQR, 7.5-14.0] in the water group (P = 0.43). No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
LIMITATIONS, REASONS FOR CAUTION
A relatively small sample size and possible attrition at follow-up are limitations of this study. Although our results suggest that the use of iodinated contrast media for HSG is safe for the offspring, the impact of a decrease in maternal thyroid function on offspring neurodevelopment could not be excluded, as data on maternal thyroid function after HSG and during conception were lacking.
WIDER IMPLICATIONS OF THE FINDINGS
As HSG with oil-based contrast does not affect thyroid function of the offspring, there is no reason to withhold this contrast to infertile women undergoing HSG. Future studies should investigate whether HSG with iodinated contrast influences the periconceptional maternal thyroid function and, consequently, offspring neurodevelopment.
STUDY FUNDING/COMPETING INTEREST(S)
This study received no funding. The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (Academic Medical Center and VU University Medical Center) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and intrepretation of the data. I.R. reports receiving travel fee from Guerbet. C.B.L. reports speakers fee from Ferring in the past and research grants from Ferring, Merck and Guerbet. K.D. reports receiving travel fee and speakers fee from Guerbet. B.W.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. V.M. reports receiving travel fee and speakers fee as well as research grants from Guerbet. The other authors do not report conflicts of interest.
TRIAL REGISTRATION NUMBER
Netherlands Trial Register NTR 7526 (Neonates born after the H2Oil study), NTR 3270 (original H2Oil study), www.trialregister.nl.",2020,"No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
","['in all newborns, followed by thyroid-stimulating hormone only in those with a T4 level of ≤\u2009-0.8 SD score', 'infertile women undergoing HSG', 'NTR 7526 (Neonates born after the H2Oil study), NTR 3270 (original H2Oil study), www.trialregister.nl', 'East Asian population', 'Of the 369 women who had a live born infant', '208 consented to be approached for future research and 138 provided informed consent to collect data on the thyroid function tests of their offspring (n\u2009=\u2009140']","['Oil-based contrast contains more iodine', 'HSG']","['neonatal thyroid function', 'maternal thyroid function', 'Thyroid function', 'risk of congenital hypothyroidism (CH', 'median T4 concentration', 'total thyroxine (T4', 'T4 concentrations']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0040130', 'cui_str': 'Thyroid panel'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010308', 'cui_str': 'Congenital hypothyroidism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]",214.0,0.03966,"No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Roest', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Portela', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Koks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, De Run 4600, 5504 DB, Veldhoven, the Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Scenic Blvd, Clayton, VIC 3800, Australia.'}, {'ForeName': 'M J J', 'Initials': 'MJJ', 'LastName': 'Finken', 'Affiliation': ""Department of Paediatric Endocrinology, Amsterdam UMC, Vrije Universiteit Amsterdam, Emma Children's Hospital, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa049']
2149,32492933,Caffeine and Gastric Emptying Time in Very Preterm Neonates.,"BACKGROUND
Caffeine has been commonly used for prevention and treatment of apnea-related symptoms in premature infants. However, its side effects have not been thoroughly studied. We investigated whether caffeine affects gastric motility in very-preterm (VP) neonates.
METHODS
The study is a randomized crossover clinical trial. Twenty-two neonates with mean birth weight (BW) (standard deviation-SD) 1077 (229) g and mean gestational age (GA) (SD) 28.6 (2.1) weeks were recruited. Each neonate had its gastric emptying time checked twice with ultrasound assessment of changes in antral cross sectional area (ACSA). All neonates were sequentially allocated to the caffeine group (A) and the control group (B). Complications from the gastrointestinal tract were documented throughout the study.
RESULTS
Statistically significant difference was found with regards to the gastric emptying time [median, (range)] between caffeine and control group (p = 0.040). Additionally, in the neonates with BW 1000-1500 g and GA ≥ 28 weeks, the gastric emptying time (minutes) was significantly longer during caffeine treatment [44.5 (36-68.2)] and [40 (34.5-66.5)] respectively, as compared to the gastric emptying time during no caffeine treatment [27 (24.2-30)] ( p = 0.002) and [27 (24.5-30)] ( p = 0.001). The incidence of gastrointestinal (GI) complications was significantly greater in neonates receiving caffeine [6 (27.%)] as compared with those without caffeine treatment [1 (4.6%)] ( p = 0.039).
CONCLUSIONS
During caffeine treatment, a significantly delayed gastric emptying time was noted in all study neonates, especially in these with BW 1000-1500 g and those with GA ≥ 28 weeks. Further larger studies are necessary in order to confirm this interesting finding.",2020,"Statistically significant difference was found with regards to the gastric emptying time [median, (range)] between caffeine and control group (p = 0.040).","['g and mean gestational age (GA) (SD) 28.6 (2.1) weeks were recruited', 'Twenty-two neonates with mean birth weight (BW) (standard deviation-SD) 1077 (229', 'very-preterm (VP) neonates', 'premature infants', 'Very Preterm Neonates']","['caffeine', 'Caffeine']","['gastric emptying time', 'incidence of gastrointestinal (GI) complications', 'gastric motility', 'gastric emptying time checked twice with ultrasound assessment of changes in antral cross sectional area (ACSA', 'delayed gastric emptying time']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517679', 'cui_str': '28.6'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}, {'cui': 'C0232572', 'cui_str': 'Gastric motility'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",22.0,0.0751421,"Statistically significant difference was found with regards to the gastric emptying time [median, (range)] between caffeine and control group (p = 0.040).","[{'ForeName': 'Antonios K', 'Initials': 'AK', 'LastName': 'Gounaris', 'Affiliation': 'Neonatal Clinic-NICU, University General Hospital, 41222 Larissa, Greece.'}, {'ForeName': 'Ioanna N', 'Initials': 'IN', 'LastName': 'Grivea', 'Affiliation': 'Neonatal Clinic-NICU, University General Hospital, 41222 Larissa, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baltogianni', 'Affiliation': 'Neonatal Clinic-NICU, University General Hospital, 451 10 Ioannina, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Gounari', 'Affiliation': ""NICU, Royal Alexandra Children's Hospital Brighton, Eastern Road, Brighton, East Sussex BN2 5BE, UK.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Antonogeorgos', 'Affiliation': 'Neonatal Clinic-NICU, General Hospital ""Agios Panteleimon"", 18454 Piraeus, Greece.'}, {'ForeName': 'Fedra', 'Initials': 'F', 'LastName': 'Kokori', 'Affiliation': 'Department of Radiology, General Hospital ""Agios Panteleimon"", 18454 Piraeus, Greece.'}, {'ForeName': 'Polytimi', 'Initials': 'P', 'LastName': 'Panagiotounakou', 'Affiliation': 'Neonatal Clinic-NICU, General Hospital ""Agios Panteleimon"", 18454 Piraeus, Greece.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Theodoraki', 'Affiliation': 'Neonatal Clinic-NICU, General Hospital ""Agios Panteleimon"", 18454 Piraeus, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Konstantinidi', 'Affiliation': 'Neonatal Clinic-NICU, General Hospital ""Agios Panteleimon"", 18454 Piraeus, Greece.'}, {'ForeName': 'Rozeta', 'Initials': 'R', 'LastName': 'Sokou', 'Affiliation': 'Neonatal Clinic-NICU, General Hospital ""Agios Panteleimon"", 18454 Piraeus, Greece.'}]",Journal of clinical medicine,['10.3390/jcm9061676']
2150,23439966,Multichannel Electromyographic Mapping to Optimize OnabotulinumtoxinA Efficacy in Cervical Dystonia.,"BACKGROUND
Cervical dystonia (CD) is characterized by sustained, involuntary contraction of head and neck muscles. Botulinum toxin injections are established as safe and effective, but unfortunately 15-25% of patients fail to respond. The aim of this study was to examine whether multichannel electromyogaphic mapping improved outcomes in a cohort of antibody-negative onabotulinumtoxinA non-responders by more precisely identifying which muscles were involved in the dystonia.
METHODS
Patients with cervical dystonia who had ""failed chemodenervation therapy"" administered by an outside provider were enrolled in a single-blind, randomized, crossover design study. Patients received either a multichannel electromyographic mapping study prior to the first botulinum toxin injection, which was followed by use of only a single-lead injection 16 weeks later (injected by an alternate and blinded movement disorders specialist) or vice versa. The primary outcome measure was change in total Toronto Western Spasmodic Torticollis Rating Scale score 4 weeks after each injection compared with each pre-injection baseline score.
RESULTS
Nine subjects completed this study. Mean percentage improvement in Total Toronto Western Spasmodic Torticollis Rating Scale was 23.5% using multichannel electromyography compared with 9% using the single-channel technique (p = 0.11).
DISCUSSION
This pilot study suggests that multichannel electromyographic mapping may result in improved efficacy in the treatment of antibody-negative onabotulinumtoxinA refractory CD.",2012,"Mean percentage improvement in Total Toronto Western Spasmodic Torticollis Rating Scale was 23.5% using multichannel electromyography compared with 9% using the single-channel technique (p = 0.11).
","['Nine subjects completed this study', 'Patients with cervical dystonia who had ""failed chemodenervation therapy"" administered by an outside provider', 'Cervical Dystonia']","['Botulinum toxin injections', 'multichannel electromyogaphic', 'multichannel electromyographic mapping study prior to the first botulinum toxin injection', 'Multichannel Electromyographic Mapping', 'multichannel electromyographic mapping', 'multichannel electromyography']","['change in total Toronto Western Spasmodic Torticollis Rating Scale score', 'Total Toronto Western Spasmodic Torticollis Rating Scale']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}]","[{'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0778944,"Mean percentage improvement in Total Toronto Western Spasmodic Torticollis Rating Scale was 23.5% using multichannel electromyography compared with 9% using the single-channel technique (p = 0.11).
","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Kilbane', 'Affiliation': ""Department of Neurology, University of California, San Francisco, San Francisco, California, United States of America ; Parkinson's Disease Research, Education, and Clinical Center, San Francisco Veterans Affairs Medical Center, San Francisco, United States of America.""}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Ostrem', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': ''}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Grace', 'Affiliation': ''}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Markun', 'Affiliation': ''}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Glass', 'Affiliation': ''}]","Tremor and other hyperkinetic movements (New York, N.Y.)",['10.7916/D8XK8D8V']
2151,23277740,Efficacy of sorafenib after liver transplantation in patients with primary hepatic carcinoma exceeding the Milan criteria: a preliminary study.,"BACKGROUND
The purpose of this study was to determine the efficacy of sorafenib in preventing and treating tumor recurrence after liver transplantation in patients with primary hepatic carcinoma exceeding the Milan criteria.
METHODS
Thirty patients with primary hepatic carcinoma exceeding the Milan criteria underwent liver transplantation at our hospital between March 2008 and June 2010. Matched for age and gender, the patients were randomized to treatment with sorafenib 400 mg bid or capecitabine (control group, 1500 mg bid, administered for 2 weeks followed by a 2-week rest interval in each cycle). Treatments were discontinued 18 months after transplantation if no recurrence occurred. Patients who experienced tumor recurrence continued their allocated treatment until they were deemed no longer suitable for the medication. Sorafenib and capecitabine were stopped or their dose was reduced in patients with severe adverse reactions.
RESULTS
The one-year recurrence rates were 53.3% and 86.6% in patients treated with sorafenib and capecitabine, respectively (χ(2) = 3.968, P < 0.05), and the one-year survival rates were 93.3% and 46.6%, respectively (χ(2) = 7.777, P < 0.05). Mean survival time was significantly longer in the sorafenib group (24.6 ± 1.7 [range 7-28] months) than in the capecitabine group (16.4 ± 2.7 [range 5-34], months (χ(2) = 7.154, P < 0.05). Most treatment-emergent adverse reactions in both treatment groups were of grade 1 or 2 in severity. The incidence of diarrhea and hand-foot syndrome tended to be higher in the sorafenib group.
CONCLUSION
For patients with primary hepatic carcinoma exceeding the Milan criteria, sorafenib may reduce or delay tumor recurrence after liver transplantation and prolong patient survival, with tolerable side effects.",2012,"CONCLUSION
For patients with primary hepatic carcinoma exceeding the Milan criteria, sorafenib may reduce or delay tumor recurrence after liver transplantation and prolong patient survival, with tolerable side effects.","['patients with primary hepatic carcinoma exceeding the Milan criteria', 'Thirty patients with primary hepatic carcinoma exceeding the Milan criteria underwent liver transplantation at our hospital between March 2008 and June 2010', 'patients with primary hepatic carcinoma', 'patients with severe adverse reactions']","['capecitabine', 'sorafenib 400 mg bid or capecitabine', 'sorafenib and capecitabine', 'sorafenib', 'Sorafenib and capecitabine']","['Mean survival time', 'tumor recurrence', 'recurrence rates', 'incidence of diarrhea and hand-foot syndrome', 'one-year survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",30.0,0.0571321,"CONCLUSION
For patients with primary hepatic carcinoma exceeding the Milan criteria, sorafenib may reduce or delay tumor recurrence after liver transplantation and prolong patient survival, with tolerable side effects.","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Center of Hepatobiliary Surgery, Peking University People's Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Guang-Ming', 'Initials': 'GM', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ji-Ye', 'Initials': 'JY', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xi-Sheng', 'Initials': 'XS', 'LastName': 'Leng', 'Affiliation': ''}]",OncoTargets and therapy,['10.2147/OTT.S31387']
2152,32493052,Continuous intravenous versus intermittent bolus midazolam with remifentanil during arteriovenous fistula placement with monitored anesthesia care in chronic renal failure patients: a randomized controlled trial.,"BACKGROUND
There is limited data on the use of intravenous continuous infusion (CI) versus intravenous intermittent bolus (IB) doses of midazolam for conscious sedation in patients with chronic renal failure. Unexpected adverse events can occur in chronic renal failure patients undergoing short procedures.
OBJECTIVE
Investigate and compare the sedoanalgesic and adverse effects of intravenous continuous infusion (CI) use of midazolam with intravenous intermittent bolus (IB) doses of midazolam while using intravenous remifentanil as a rescue medication, and assess patient and surgeon satisfaction.
DESIGN
Prospective, randomized, single-blind controlled study.
SETTINGS
Two tertiary care hospitals.
PATIENTS AND METHODS
Study included patients aged 43-81 years with a diagnosis of chronic renal failure who were referred for an arteriovenous fistula procedure with modified anesthesia care between August 2012 and April 2016. The patients were randomized to intravenous CI or IB doses of midazolam. IB doses of remifentanil were used as a rescue medication.
MAIN OUTCOME MEASURES
Primary outcomes were amounts of midazolam and remifentanil medications during the operation, the amount of remifentanil as a rescue medication, and the satisfaction of patient and surgeon.
SAMPLE SIZE
116 assessed for eligibility; 99 randomized to CI (n=50) or IB doses (n=49 of midazolam).
RESULTS
The total dose of midazolam by CI was greater than with midazolam by IB ( P =.002). The total dose of remifentanil was higher with IB doses of midazolam in comparison to CI of midazolam ( P =.001). The groups were similar in sedation and pain control, duration of procedure, recovery time, patient satisfaction and adverse events; surgeon satisfaction was greater with CI versus IB ( P =.035).
CONCLUSION
Intravenous CI midazolam during MAC provides better surgeon satisfaction then IB midazolam and can be used safely for arteriovenous fistula procedures.
LIMITATIONS
Two different surgeon groups.
CONFLICT OF INTEREST
None.",2020,"The groups were similar in sedation and pain control, duration of procedure, recovery time, patient satisfaction and adverse events; surgeon satisfaction was greater with CI versus IB ( P =.035).
","['Study included patients aged 43-81 years with a diagnosis of chronic renal failure who were referred for an arteriovenous fistula procedure with modified anesthesia care between August 2012 and April 2016', 'patients with chronic renal failure', 'chronic renal failure patients undergoing short procedures', 'Two tertiary care hospitals', 'chronic renal failure patients']","['Intravenous CI midazolam', 'remifentanil', 'midazolam with remifentanil', 'midazolam', 'intravenous continuous infusion (CI', 'intravenous continuous infusion (CI) versus intravenous intermittent bolus (IB) doses of midazolam']","['amounts of midazolam and remifentanil medications during the operation, the amount of remifentanil as a rescue medication, and the satisfaction of patient and surgeon', 'sedation and pain control, duration of procedure, recovery time, patient satisfaction and adverse events; surgeon satisfaction']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.247795,"The groups were similar in sedation and pain control, duration of procedure, recovery time, patient satisfaction and adverse events; surgeon satisfaction was greater with CI versus IB ( P =.035).
","[{'ForeName': 'Gonul', 'Initials': 'G', 'LastName': 'Sagiroglu', 'Affiliation': 'From the Department of Anesthesiology, Faculty of Medicine, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Baysal', 'Affiliation': 'From the Department of Anesthesiology and Reanimation, Pendik Bolge Hospital, Istanbul, Turkey.'}]",Annals of Saudi medicine,['10.5144/0256-4947.2020.175']
2153,23162402,Effect of fentanyl versus buprenorphine on the pupil size in phacoemulsification cataract surgery.,"BACKGROUND
Despite several recent innovations in phacoemulsification surgery, importance of pupil diameter in this surgery is becoming more evident.
PURPOSE
To compare the effect of opioid agonist (fentanyl) versus opioid agonist-antagonist (buprenorphine) on pupil diameter in cataract surgery and to choose the best opioid in high-risk phacoemulsification surgery.
METHODS
In this randomized double-blinded clinical trial, 60 patients who were candidates for elective phacoemulsification surgery were randomly divided into two equal groups: experimental (buprenorphine, 0.3 μg/kg) and control (fentanyl, 1 μg/kg). Pupil diameter was measured preinjection and at several times postinjection. Blood pressure was recorded at several intervals, as well as shivering, nausea and vomiting, and recovery time.
RESULTS
Mean (SD) recovery time was significantly less in the control group (19.46±5.43) than in the experimental group (33.23±10.75) (P<0.0001). The constriction effect (ie, pupillary diameter in mm) was significantly lower in the experimental group (0.53±0.45) than in the control group (1.06±0.52) (P=0.0001). The percentages of constriction effect in experimentaland control groups were 7.68% and 15.07%, respectively. The eye was two times more constricted in the control group in comparison with the experimental group after induction of anesthesia.
CONCLUSION
Buprenorphine is a better solution to decrease pupil constriction in comparison with fentanylinhigh-risk phacoemulsification surgery.",2012,"The constriction effect (ie, pupillary diameter in mm) was significantly lower in the experimental group (0.53±0.45) than in the control group (1.06±0.52) (P=0.0001).","['phacoemulsification cataract surgery', '60 patients who were candidates for elective phacoemulsification surgery']","['opioid agonist (fentanyl', 'Buprenorphine', 'experimental (buprenorphine, 0.3 μg/kg) and control (fentanyl', 'buprenorphine', 'fentanyl', 'opioid agonist-antagonist (buprenorphine']","['shivering, nausea and vomiting, and recovery time', 'pupil size', 'Blood pressure', 'Pupil diameter', 'pupil constriction', 'constriction effect (ie, pupillary diameter in mm', 'Mean (SD) recovery time', 'percentages of constriction effect']","[{'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0728710', 'cui_str': 'Pupil constriction (observable entity)'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",60.0,0.0879724,"The constriction effect (ie, pupillary diameter in mm) was significantly lower in the experimental group (0.53±0.45) than in the control group (1.06±0.52) (P=0.0001).","[{'ForeName': 'Abdolreza Najafi', 'Initials': 'AN', 'LastName': 'Anaraki', 'Affiliation': 'Department of Anesthesiology, Bushehr University of Medical Sciences, Bushehr, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Akrami', 'Affiliation': ''}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Motamed', 'Affiliation': ''}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Seydali', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101220']
2154,23162403,"Evaluation of single epidural bolus dose of magnesium as an adjuvant to epidural fentanyl for postoperative analgesia: A prospective, randomized, double-blind study.","OBJECTIVE
Magnesium has been used as an adjuvant by various routes, including intravenous, intrathecal, and epidural in different dosage regimens. The effect of single bolus dose of magnesium as an adjuvant to fentanyl for postoperative analgesia has not been studied. This prospective randomized controlled trial was done to evaluate the efficacy of single bolus administration of magnesium epidurally as an adjuvant to epidural fentanyl for postoperative analgesia in patients undergoing total hip replacement under combined spinal epidural anesthesia.
METHODS
Sixty patients received combined spinal-epidural anesthesia with 2 mL of 0.5% hyperbaric bupivacaine intrathecally. After the surgery, patients were randomized into Group F [epidural fentanyl (1 μg/kg) in 10 mL saline] and Group FM [epidural magnesium (75 mg) along with fentanyl (1 μg/kg) in 10 mL saline]. Supplementary analgesia was provided by 50 mg intravenous tramadol if Verbal Rating Score (VRS) >4. Patient's first analgesic requirement and duration of analgesia were recorded.
RESULTS
The duration of analgesia was significantly longer for Group FM, 340±28.8 min, compared with Group F, 164±17.1 min (P=0.001). The frequency of rescue analgesics required in 24-h postoperative period in Group FM (2.3±0.5) was significantly less than that in Group F (4.3±0.5) (P=0.001). VRS was significantly lower in Group FM up to 4 h in the postoperative period (P=0.001). Bromage scale was statistically insignificant at all points of time.
CONCLUSIONS
The administration of magnesium (75 mg) as an adjuvant to epidural fentanyl (1 μg/ kg) for postoperative analgesia results in significantly lower VRS with prolonged duration of analgesia as compared with epidural fentanyl (1 μg/kg) alone. Concomitant administration of magnesium also reduces the requirement of breakthrough analgesics with no increased incidence of side effects.",2012,VRS was significantly lower in Group FM up to 4 h in the postoperative period (P=0.001).,"['patients undergoing total hip replacement under combined spinal epidural anesthesia', 'Sixty patients received', 'postoperative analgesia']","['Group F [epidural fentanyl (1 μg/kg) in 10 mL saline] and Group FM [epidural magnesium', 'epidural fentanyl', 'fentanyl', 'magnesium', 'combined spinal-epidural anesthesia with 2 mL of 0.5% hyperbaric bupivacaine intrathecally']","['side effects', 'VRS', 'frequency of rescue analgesics', 'duration of analgesia', 'analgesic requirement and duration of analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0441840', 'cui_str': 'Group F (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",,0.571345,VRS was significantly lower in Group FM up to 4 h in the postoperative period (P=0.001).,"[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Banwait', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Postgraduate Institute of Medical Education and Research and Dr. Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Mridula', 'Initials': 'M', 'LastName': 'Pawar', 'Affiliation': ''}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sood', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101221']
2155,22847485,"Specificity of effects of cognitive behavior therapy on coping, acceptance, and distress tolerance in a randomized controlled trial for smoking cessation.","OBJECTIVE
Although there is extensive evidence of the efficacy of cognitive-behavioral therapy (CBT), it is less certain what potential mechanisms of change are specifically affected by CBT interventions. This study was intended to test the specific effects of CBT on compensatory coping skills, acceptance, and distress tolerance or persistence.
METHOD
Using data from a randomized controlled trial of 8-session group CBT and a time-matched comparison condition for cigarette smokers, we evaluated CBT effects on compensatory coping skills, self-rated acceptance and behavioral markers of persistence and distress tolerance. Because depression proneness had moderated treatment response in the parent clinical trial (Kapson & Haaga, 2010), we tested not only main effects (CBT vs. comparison condition) but also moderated effects (treatment condition X depression proneness).
RESULTS
CBT significantly improved compensatory coping skills only among the less depression-prone participants, who were the subset of smokers who did not benefit from CBT in terms of smoking cessation outcomes. There were no specific effects of CBT on acceptance or behavioral persistence.
CONCLUSIONS
To the extent that CBT had specific effects on compensatory coping skills, it was for the participants who did not benefit clinically from the intervention. Much more theory-driven research on multiple candidate change mechanisms is needed to clarify how effective and specific treatments have their effects, for either patients in general or subsets of patients as in moderated effects.",2012,"This study was intended to test the specific effects of CBT on compensatory coping skills, acceptance, and distress tolerance or persistence.
",['cigarette smokers'],"['cognitive-behavioral therapy (CBT', 'cognitive behavior therapy', 'CBT', '8-session group CBT']","['compensatory coping skills, acceptance, and distress tolerance or persistence', 'acceptance or behavioral persistence', 'compensatory coping skills', 'coping, acceptance, and distress tolerance', 'compensatory coping skills, self-rated acceptance and behavioral markers of persistence and distress tolerance']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0668348,"This study was intended to test the specific effects of CBT on compensatory coping skills, acceptance, and distress tolerance or persistence.
","[{'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Kapson', 'Affiliation': 'American University, Washington, District of Columbia 20016–8062, USA.'}, {'ForeName': 'Meaghan A', 'Initials': 'MA', 'LastName': 'Leddy', 'Affiliation': ''}, {'ForeName': 'David A F', 'Initials': 'DA', 'LastName': 'Haaga', 'Affiliation': ''}]",Journal of clinical psychology,['10.1002/jclp.21903']
2156,22754434,Ultrasound-guided single injection infraclavicular brachial plexus block using bupivacaine alone or combined with dexmedetomidine for pain control in upper limb surgery: A prospective randomized controlled trial.,"BACKGROUND
Dexmedetomidine, is a selective α2-adrenoceptor agonist that is used as an adjuvant mixed with local anesthetics during regional anesthesia. This study was designed to test the efficacy of adding dexmedetomidine to bupivacaine during placement of infraclavicular brachial plexus blockade (ICB).
METHODS
Sixty adult patients were divided into 2 equal groups of 30 subjects each. Patients in Group I received an ICB using 30 mL of 0.33% bupivacaine and Group II patients received 30 mL of 0.33% bupivacaine mixed with 0.75 μg/kg of dexmedetomidine. The following brachial plexus nerve block parameters were assessed: block success rate, sensory onset time and duration, motor block onset time and duration, analgesic pain scores using the verbal rating scale (VRS) for pain, duration of analgesia, and amount of supplemental intravenous (IV) morphine required.
RESULTS
There was a statistically significant shorter time to onset of sensory blockade (13.2 vs 19.4 min, P=0.003), longer duration of sensory block (179.4 vs 122.7 min, P=0.002), shorter onset time to achieve motor block (15.3 vs 22.2 min, P=0.003), longer duration of motor block (155.5 vs 105.7 min, P=0.002), lower VRS pain scores, prolonged analgesia (403 vs 233 min, P=0.002), and lower morphine rescue requirements for 48 h after surgery (4.9 (0-8.0) vs 13.6 mg (4.0-16.0) mg, P=0.005). All patients recovered without evidence of sensory or motor deficit.
CONCLUSION
ADDING DEXMEDETOMIDINE TO BUPIVACAINE DURING THE PLACEMENT OF AN ICB PROVIDES: (1) enhancement of onset of sensory and motor blockade, (2) prolonged duration of analgesia, (3) increases duration of sensory and motor block, (4) yields lower VRS pain scores, and (5) reduces supplemental opioid requirements.",2012,"The following brachial plexus nerve block parameters were assessed: block success rate, sensory onset time and duration, motor block onset time and duration, analgesic pain scores using the verbal rating scale (VRS) for pain, duration of analgesia, and amount of supplemental intravenous (IV) morphine required.
","['pain control in upper limb surgery', 'Sixty adult patients were divided into 2 equal groups of 30 subjects each']","['ICB', 'bupivacaine alone or combined with dexmedetomidine', 'Dexmedetomidine', 'bupivacaine', 'dexmedetomidine']","['block success rate, sensory onset time and duration, motor block onset time and duration, analgesic pain scores using the verbal rating scale (VRS) for pain, duration of analgesia, and amount of supplemental intravenous (IV) morphine required', 'longer duration of sensory block', 'shorter time to onset of sensory blockade', 'shorter onset time to achieve motor block', '1) enhancement of onset of sensory and motor blockade, (2) prolonged duration of analgesia, (3) increases duration of sensory and motor block, (4) yields lower VRS pain scores, and (5) reduces supplemental opioid requirements', 'morphine rescue requirements', 'lower VRS pain scores, prolonged analgesia', 'longer duration of motor block']","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale (assessment scale)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",60.0,0.232882,"The following brachial plexus nerve block parameters were assessed: block success rate, sensory onset time and duration, motor block onset time and duration, analgesic pain scores using the verbal rating scale (VRS) for pain, duration of analgesia, and amount of supplemental intravenous (IV) morphine required.
","[{'ForeName': 'Amany S', 'Initials': 'AS', 'LastName': 'Ammar', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Minoufiya University, Shebin El Kom, Minoufiya, Egypt.'}, {'ForeName': 'Khaled M', 'Initials': 'KM', 'LastName': 'Mahmoud', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.97021']
2157,32114531,Effect modifiers for patient-reported outcomes in operatively and nonoperatively treated patients with adult symptomatic lumbar scoliosis: a combined analysis of randomized and observational cohorts.,"OBJECTIVE
Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS.
METHODS
Patients 40-80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7).
RESULTS
Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence-lumbar lordosis (PI-LL) match (≤ 11°). Male patients and patients with more (> 11°) PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes.
CONCLUSIONS
Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI-LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.",2020,PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment.,"['patient-reported outcomes in operatively and nonoperatively treated patients with adult symptomatic lumbar scoliosis', 'Male patients and patients with more (> 11°', 'Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment', 'Patients 40-80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers', 'Adult symptomatic lumbar scoliosis (ASLS']",['ASLS-1'],"['High BMI, lower socioeconomic status, and poor mental health', 'mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI']","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2748518', 'cui_str': 'Lumbar scoliosis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",286.0,0.0431524,PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment.,"[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Yanik', 'Affiliation': '1Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Kelly', 'Affiliation': '1Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Lurie', 'Affiliation': '2Department of Medicine, Dartmouth Medical School, Hanover, New Hampshire.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'Baldus', 'Affiliation': '1Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Shaffrey', 'Affiliation': '4Department of Neurological Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Schwab', 'Affiliation': '5Hospital for Special Surgery, New York, New York; and.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Bess', 'Affiliation': '3Denver International Spine Center, Denver, Colorado.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Lenke', 'Affiliation': '6Department of Orthopedic Surgery, Columbia University, New York, New York.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'LaBore', 'Affiliation': '1Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Keith H', 'Initials': 'KH', 'LastName': 'Bridwell', 'Affiliation': '1Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}]",Journal of neurosurgery. Spine,['10.3171/2020.1.SPINE191288']
2158,23162389,Comparison of caudal analgesia between ropivacaine and ropivacaine with clonidine in children: A randomized controlled trial.,"BACKGROUND
Addition of clonidine to ropivacaine (0.2%) can potentially enhance analgesia without producing prolonged motor blockade. The aim of the present study was to compare the post-operative pain relieving quality of ropivacaine 0.2% and clonidine mixture to that of plain ropivacaine 0.2% following caudal administration in children.
METHODS
In a prospective, double-blinded, randomized controlled trial, 30 ASA 1 pediatric patients undergoing infraumbilical surgery were randomly allocated to receive a caudal injection of either plain ropivacaine 0.2% (1 ml/kg) (group A) or a mixture of ropivacaine 0.2% (1 ml/kg) with clonidine 2 μg/kg (group B). Objective pain score and need for supplemental analgesics were compared during the 1(st) 24 hours postoperatively. Residual post-operative sedation and motor blockade were also assessed.
RESULTS
Significantly prolonged duration of post-operative analgesia was observed in group B (P<0.0001). Heart rate and blood pressure were not different in 2 groups. Neither motor blockade nor post-operative sedation varied significantly between the groups.
CONCLUSION
The combination of clonidine (2 μg/kg) and ropivacaine 0.2% was associated with an improved quality of post-operative analgesia compared to plain 0.2% ropivacaine. The improved analgesic quality of the clonidine-ropivacaine mixture was achieved without causing any significant degree of post-operative sedation or prolongation of motor blockade.",2012,The improved analgesic quality of the clonidine-ropivacaine mixture was achieved without causing any significant degree of post-operative sedation or prolongation of motor blockade.,"['30 ASA 1 pediatric patients undergoing infraumbilical surgery', 'children']","['clonidine', 'clonidine mixture', 'ropivacaine', 'caudal injection of either plain ropivacaine', 'clonidine-ropivacaine', 'plain ropivacaine']","['Objective pain score and need for supplemental analgesics', 'analgesic quality', 'Heart rate and blood pressure', 'prolonged duration of post-operative analgesia', 'quality of post-operative analgesia', 'motor blockade nor post-operative sedation']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",30.0,0.475314,The improved analgesic quality of the clonidine-ropivacaine mixture was achieved without causing any significant degree of post-operative sedation or prolongation of motor blockade.,"[{'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Laha', 'Affiliation': 'Department of Anaesthesiology, R. G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Sarmila', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': ''}, {'ForeName': 'Haripada', 'Initials': 'H', 'LastName': 'Das', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101199']
2159,23162390,Comparison between intrathecal morphine with paravertebral patient controlled analgesia using bupivacaine for intraoperative and post-thoracotomy pain relief.,"OBJECTIVES
This study was designed to compare the intrathecal morphine and paravertebral block with bupivacaine given before induction of anesthesia for intra-operative and post-thoracotomy pain relief for 48 hours using patient controlled paravertebral analgesia in post-operative period.
METHODS
After taken an approval from the ethics committee of the University, 40 patients were randomly assigned to receive either preservative-free intrathecal morphine 0.3 mg in 3 ml normal saline together with paravertebral block (group I) or paravertebral block alone using bupivacaine (group II) before an induction of anesthesia. No continuous infusion of bupivacaine was started in both groups. Primary outcomes were Visual Analogue Score (VAS) at rest and on coughing. Hemodynamic and respiratory effects, bupivacaine consumption, patient's satisfaction, and side effects like nausea, vomiting, urinary retention, and itching were considered as secondary outcomes. All patients in both groups received paracetamol 1 gram (gm) IV every 6 hourly for the 1(st) 24 hr. Amount of rescue analgesic (pethidine 0.5 mg/kg IV) in both groups and total bupivacaine cumulative doses in 48 hrs were calculated.
RESULTS
VAS at rest and on coughing did not differ significantly between the 2 groups at 0, 1, 6, 12, 18, 24, and 48 hours (P= >0.1). At 24 hours, VAS increased in both the groups, but the increase in VAS was comparable in both groups. There were insignificant incidences of nausea, purities, and urinary retention in intrathecal group compared with paravertebral group. The other side effects and patient satisfaction did not show any statistical significant difference between 2 groups.
CONCLUSION
Intrathecal morphine 0.3 mg is safe and effective way to improves pain control for thoracic surgery and was comparable to paravertebral patient control analgesia (PPCA) with bupivacaine for the 1(st) 48 hours post-thoracotomy.",2012,Intrathecal morphine 0.3 mg is safe and effective way to improves pain control for thoracic surgery and was comparable to paravertebral patient control analgesia (PPCA) with bupivacaine for the 1(st) 48 hours post-thoracotomy.,"['48 hours using patient controlled paravertebral analgesia in post-operative period', '40 patients']","['Intrathecal morphine', 'bupivacaine', 'preservative-free intrathecal morphine 0.3 mg in 3 ml normal saline together with paravertebral block (group I) or paravertebral block alone using bupivacaine', 'paracetamol', 'intrathecal morphine', 'rescue analgesic (pethidine']","[""Hemodynamic and respiratory effects, bupivacaine consumption, patient's satisfaction, and side effects like nausea, vomiting, urinary retention, and itching"", 'VAS', 'VAS at rest and on coughing', 'side effects and patient satisfaction', 'pain control', 'Visual Analogue Score (VAS) at rest and on coughing', 'nausea, purities, and urinary retention']","[{'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.0524043,Intrathecal morphine 0.3 mg is safe and effective way to improves pain control for thoracic surgery and was comparable to paravertebral patient control analgesia (PPCA) with bupivacaine for the 1(st) 48 hours post-thoracotomy.,"[{'ForeName': 'Haitham Abou', 'Initials': 'HA', 'LastName': 'Zeid', 'Affiliation': 'Department of Anesthesiology, King Fahd Hospital of the University, University of Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Ahsan Khaliq', 'Initials': 'AK', 'LastName': 'Siddiqui', 'Affiliation': ''}, {'ForeName': 'Ehab F A', 'Initials': 'EF', 'LastName': 'Elmakarem', 'Affiliation': ''}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Ghonaimy', 'Affiliation': ''}, {'ForeName': 'Awatif', 'Initials': 'A', 'LastName': 'Al Nafea', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101204']
2160,23162391,"A randomized, clinical trial of ketorolac tromethamine vs ketorolac trometamine plus complex B vitamins for cesarean delivery analgesia.","BACKGROUND
Ketorolac is widely used for postoperative analgesia in patients who undergo cesarean delivery. In countries where the use of opioids is considerably restricted, alternatives to narcotics are required.
AIM
We hypothesize that the addition of complex B synergize the analgesic effect of ketorolac in postoperative cesarean patients, thus requiring a smaller dose of the anti-inflammatory agent, and therefore decreasing the potential side effects of ketorolac.
METHODS
A randomized clinical trial with 100 patients undergoing a primary elective cesarean delivery enrolled in the study. Pain was assessed in the recovery room and then they were randomized to receive ketorolac 30 mg intramuscular (i.m.) or 15 mg of ketorolac plus complex B vitamin (CBV). The pain score with an analog scale was assessed 1, 2, 6, 12, 18, and 24 h after the baseline. The student's t test was performed to compare the demographic differences between the 2 means.
RESULTS
100 patients were included in the study, showing no statistical differences in the demographics. The patient's pain score at 1, 2, 6, 12, 18 and 24 hours showed no statistical differences between the control group (ketorolac 30mg) compared to the group of ketorolac 15mg and complex B vitamins. No changes in the coagulation studies were found in both groups.
CONCLUSION
The present study demonstrates that ketorolac 30 mg and ketorolac 15 mg plus complex B vitamins can provide acceptable analgesia in many patients with severe pain.",2012,"The patient's pain score at 1, 2, 6, 12, 18 and 24 hours showed no statistical differences between the control group (ketorolac 30mg) compared to the group of ketorolac 15mg and complex B vitamins.","['100 patients undergoing a primary elective cesarean delivery enrolled in the study', '100 patients', 'patients who undergo cesarean delivery', 'cesarean delivery analgesia', 'patients with severe pain', 'postoperative cesarean patients']","['ketorolac', 'ketorolac tromethamine vs ketorolac trometamine plus complex B vitamins', 'ketorolac plus complex B vitamin (CBV', 'ketorolac 15 mg plus complex B vitamins', 'Ketorolac']","['pain score with an analog scale', 'Pain', ""patient's pain score""]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0064326', 'cui_str': 'Ketorolac Tromethamine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",100.0,0.10359,"The patient's pain score at 1, 2, 6, 12, 18 and 24 hours showed no statistical differences between the control group (ketorolac 30mg) compared to the group of ketorolac 15mg and complex B vitamins.","[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Beltrán-Montoya', 'Affiliation': 'Department of Obstetrics and Gynecology, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes. Montes Urales 800 Lomas Virreyes, Distrito Federal, Mexico.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Herrerias-Canedo', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arzola-Paniagua', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vadillo-Ortega', 'Affiliation': ''}, {'ForeName': 'Omar Felipe', 'Initials': 'OF', 'LastName': 'Dueñas-Garcia', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rico-Olvera', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101209']
2161,23162393,Dexmedetomidine premedication for fiberoptic intubation in patients of temporomandibular joint ankylosis: A randomized clinical trial.,"BACKGROUND
Fiberoptic intubation is the gold standard technique for difficult airway management in patients of temporomandibular joint. This study was aimed to evaluate the clinical efficacy and safety of dexmedetomidine as premedication with propofol infusion for fiberoptic intubation.
METHODS
Consent was obtained from 46 adult patients of temporomandibular joint ankylosis, scheduled for gap arthroplasty. They were enrolled for thisdouble-blind, randomized, prospective clinical trial with two treatment groups - Group D and Group P, of 23 patients each. Group D patients had received premedication of dexmedetomidine 1 μg/kg infused over 10 min followed by sedative propofol infusion and the control Group P patients were given only propofol infusion to achieve sedation. Condition achieved at endoscopy, intubating conditions, hemodynamic changes and postoperative events were evaluated as primary outcome.
RESULTS
The fiberoptic intubation was successful with satisfactory endoscopic and intubating condition in all patients. Dexmedetomidine premedication has provided satisfactory conditions for fiberoptic intubation and attenuated the hemodynamic response of fiberoptic intubation than the propofol group.
CONCLUSION
Fiberoptic intubation was found to be easier with dexmedetomidine premedication along with sedative infusion of propofol with complete amnesia of the procedure, hemodynamic stability and preservation of patent airway.",2012,"Fiberoptic intubation was found to be easier with dexmedetomidine premedication along with sedative infusion of propofol with complete amnesia of the procedure, hemodynamic stability and preservation of patent airway.","['patients of temporomandibular joint', 'patients of temporomandibular joint ankylosis', '46 adult patients of temporomandibular joint ankylosis, scheduled for gap arthroplasty']","['Fiberoptic intubation', 'Dexmedetomidine', 'fiberoptic intubation', 'propofol', 'Dexmedetomidine premedication', 'dexmedetomidine 1 μg/kg infused over 10 min followed by sedative propofol infusion and the control Group P patients were given only propofol infusion to achieve sedation', 'dexmedetomidine']","['hemodynamic response of fiberoptic intubation', 'hemodynamic stability and preservation of patent airway', 'Condition achieved at endoscopy, intubating conditions, hemodynamic changes and postoperative events', 'clinical efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C2931375', 'cui_str': 'Temporomandibular ankylosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",46.0,0.154949,"Fiberoptic intubation was found to be easier with dexmedetomidine premedication along with sedative infusion of propofol with complete amnesia of the procedure, hemodynamic stability and preservation of patent airway.","[{'ForeName': 'Kumkum', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology and Critical Care, N.S.C.B. Subharti Medical College, Subhartipuram, NH-58, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': ''}, {'ForeName': 'Prashant K', 'Initials': 'PK', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Rastogi', 'Affiliation': ''}, {'ForeName': 'Sanjeev K', 'Initials': 'SK', 'LastName': 'Saxena', 'Affiliation': ''}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Manngo', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101211']
2162,32422538,Short- and long-term changes in substance-related coping as mediators of in-person and computerized CBT for alcohol and drug use disorders.,"BACKGROUND
No studies have examined long-term changes in substance-related coping skills as a statistical mediator of cognitive-behavioral therapy (CBT) for substance use disorders (SUD).
METHODS
We tested both short- and long-term changes in coping as mediators of treatment effects in two trials of in-person and/or computerized CBT for SUD. The first trial included 137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in-person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU). The second trial included 68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following: CBT4CBT plus brief monitoring, CBT4CBT plus TAU, or TAU only. Coping was assessed with the Coping Strategies Scale. Latent growth curve mediational models were conducted, with both short-term (baseline through end-of-treatment) and long-term (baseline through 3-month post-treatment follow-up) changes in coping.
RESULTS
There were no mediation effects for short-term changes in coping. However, in both trials, there were significant mediation effects for long-term changes in coping: In trial 1, the effect of CBT4CBT vs. TAU on substance use at the 6-month follow-up was mediated by long-term increases in coping. This same mediation effect was not found for in-person CBT vs. TAU. In trial 2, the effect of CBT4CBT vs. not receiving CBT4CBT on heavy drinking at the 6-month follow-up was mediated by long-term increases in coping.
CONCLUSIONS
Long-term increases in coping may be a mechanism of change in computerized CBT for SUD.",2020,This same mediation effect was not found for in-person CBT vs. TAU.,"['68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following', 'two trials of in-person and/or computerized CBT for SUD', '137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in']","['CBT4CBT vs. TAU', 'CBT4CBT vs. not receiving CBT4CBT', 'person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU']","['coping', 'heavy drinking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",137.0,0.0462548,This same mediation effect was not found for in-person CBT vs. TAU.,"[{'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States. Electronic address: corey.roos@yale.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Frankforter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108044']
2163,22956855,Evaluation of Viable Dynamic Treatment Regimes in a Sequentially Randomized Trial of Advanced Prostate Cancer.,"We present new statistical analyses of data arising from a clinical trial designed to compare two-stage dynamic treatment regimes (DTRs) for advanced prostate cancer. The trial protocol mandated that patients were to be initially randomized among four chemotherapies, and that those who responded poorly were to be rerandomized to one of the remaining candidate therapies. The primary aim was to compare the DTRs' overall success rates, with success defined by the occurrence of successful responses in each of two consecutive courses of the patient's therapy. Of the one hundred and fifty study participants, forty seven did not complete their therapy per the algorithm. However, thirty five of them did so for reasons that precluded further chemotherapy; i.e. toxicity and/or progressive disease. Consequently, rather than comparing the overall success rates of the DTRs in the unrealistic event that these patients had remained on their assigned chemotherapies, we conducted an analysis that compared viable switch rules defined by the per-protocol rules but with the additional provision that patients who developed toxicity or progressive disease switch to a non-prespecified therapeutic or palliative strategy. This modification involved consideration of bivariate per-course outcomes encoding both efficacy and toxicity. We used numerical scores elicited from the trial's Principal Investigator to quantify the clinical desirability of each bivariate per-course outcome, and defined one endpoint as their average over all courses of treatment. Two other simpler sets of scores as well as log survival time also were used as endpoints. Estimation of each DTR-specific mean score was conducted using inverse probability weighted methods that assumed that missingness in the twelve remaining drop-outs was informative but explainable in that it only depended on past recorded data. We conducted additional worst-best case analyses to evaluate sensitivity of our findings to extreme departures from the explainable drop-out assumption.",2012,"The primary aim was to compare the DTRs' overall success rates, with success defined by the occurrence of successful responses in each of two consecutive courses of the patient's therapy.","['Advanced Prostate Cancer', 'Of the one hundred and fifty study participants, forty seven did not complete their therapy per the algorithm', 'advanced prostate cancer']",[],"['efficacy and toxicity', 'log survival time']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C0002045'}]",[],"[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",150.0,0.101857,"The primary aim was to compare the DTRs' overall success rates, with success defined by the occurrence of successful responses in each of two consecutive courses of the patient's therapy.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI 48109.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rotnitzky', 'Affiliation': ''}, {'ForeName': 'Xihong', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Randall E', 'Initials': 'RE', 'LastName': 'Millikan', 'Affiliation': ''}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': ''}]",Journal of the American Statistical Association,[]
2164,22906322,"The effect of video game ""warm-up"" on performance of laparoscopic surgery tasks.","BACKGROUND
Performing laparoscopic procedures requires special training and has been documented as a significant source of surgical errors. ""Warming up"" before performing a task has been shown to enhance performance. This study investigates whether surgeons benefit from ""warming up"" using select video games immediately before performing laparoscopic partial tasks and clinical tasks.
METHODS
This study included 303 surgeons (249 men and 54 women). Participants were split into a control (n=180) and an experimental group (n=123). The experimental group played 3 previously validated video games for 6 minutes before task sessions. The Cobra Rope partial task and suturing exercises were performed immediately after the warm-up sessions.
RESULTS
Surgeons who played video games prior to the Cobra Rope drill were significantly faster on their first attempt and across all 10 trials. The experimental and control groups were significantly different in their total suturing scores (t=2.28, df=288, P<.05). The overall Top Gun score showed that the experimental group performed marginally better overall.
CONCLUSION
This study demonstrates that subjects completing ""warming-up"" sessions with select video games prior to performing laparoscopic partial and clinical tasks (intracorporeal suturing) were faster and had fewer errors than participants not engaging in ""warm-up."" More study is needed to determine whether this translates into superior procedural execution in the clinical setting.",2012,"The experimental and control groups were significantly different in their total suturing scores (t=2.28, df=288, P<.05).",['303 surgeons (249 men and 54 women'],"['warming-up"" sessions with select video games prior to performing laparoscopic partial and clinical tasks (intracorporeal suturing) were faster and had fewer errors than participants not engaging in ""warm-up', 'video game ""warm-up', 'Cobra Rope partial task and suturing exercises']","['overall Top Gun score', 'total suturing scores']","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0206326', 'cui_str': 'Cobra'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018397', 'cui_str': 'Guns'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]",303.0,0.0248014,"The experimental and control groups were significantly different in their total suturing scores (t=2.28, df=288, P<.05).","[{'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Rosser', 'Affiliation': 'Morehouse School of Medicine, Atlanta, GA, USA. brosser1@mac.com'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Gentile', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Hanigan', 'Affiliation': ''}, {'ForeName': 'Omar K', 'Initials': 'OK', 'LastName': 'Danner', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680812X13291597715664']
2165,31867655,Examining Age as a Potential Moderator of Response to Reduced Nicotine Content Cigarettes in Vulnerable Populations.,"INTRODUCTION
Young adults (aged 18-24 years) have a higher smoking prevalence than younger and older age groups and young adulthood is an important developmental period during which long-term behavior patterns like cigarette smoking are established. The aim of the current study was to examine how young adult smokers with additional vulnerabilities to smoking respond to reduced nicotine content cigarettes.
METHODS
This is a secondary analysis of a double-blind, within-subject experiment conducted with 169 cigarette smokers recruited from populations with comorbid psychiatric conditions or socioeconomic disadvantage assessing acute effects of research cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g). Participants were dichotomized by chronological age (18-24 vs. ≥25 years). Across 14 laboratory sessions effects of nicotine content were examined on measures of relative reinforcing efficacy (Cigarette Purchase Task [CPT] and Concurrent Choice testing), subjective effects, craving/withdrawal, and smoking topography. Repeated measures analysis of variances were used to examine potential moderating effects of age.
RESULTS
Young adults exhibited lower demand for reduced nicotine content cigarettes than older adults across three of five CPT indices (ps < .05). No differences by age were observed on other measures of reinforcing efficacy, subjective effects, craving/withdrawal, or smoking topography where effects generally decreased as an orderly function of decreasing nicotine content (ps <.05).
CONCLUSION
Overall, these findings suggest that reducing the nicotine content of cigarettes would decrease the addiction potential of cigarette smoking in young adult smokers as much or perhaps more than older adult smokers from populations at increased vulnerability to smoking, addiction, and smoking-related health consequences.
IMPLICATIONS
Reducing the nicotine content in cigarettes to lower addiction potential of smoking has been proposed as a means to improve overall population health. It is imperative to examine how young adults may respond to a nicotine reduction policy. We saw minimal evidence that age moderates acute response and where there was evidence it was in the direction of reduced nicotine content cigarettes having less addictive potential among young versus older adults (eg, steeper decreases in demand for very low nicotine content cigarettes among young versus older adults). Overall, a nicotine reduction policy has the potential to reduce smoking across age groups.",2019,"No differences by age were observed on other measures of reinforcing efficacy, subjective effects, craving/withdrawal, or smoking topography where effects generally decreased as an orderly function of decreasing nicotine content (ps <.05).
","['Participants were dichotomized by chronological age (18-24 vs. ≥25 years', 'young adult smokers', '169 cigarette smokers recruited from populations with comorbid psychiatric conditions or socioeconomic disadvantage assessing acute effects of research cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g', 'Vulnerable Populations', 'Young adults (aged 18-24 years', 'young adult smokers with additional vulnerabilities to smoking respond to reduced nicotine content cigarettes']",[],"['addiction potential of cigarette smoking', 'relative reinforcing efficacy (Cigarette Purchase Task [CPT] and Concurrent Choice testing), subjective effects, craving/withdrawal, and smoking topography', 'nicotine content cigarettes', 'orderly function of decreasing nicotine content', 'reinforcing efficacy, subjective effects, craving/withdrawal, or smoking topography']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",[],"[{'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",,0.0203721,"No differences by age were observed on other measures of reinforcing efficacy, subjective effects, craving/withdrawal, or smoking topography where effects generally decreased as an orderly function of decreasing nicotine content (ps <.05).
","[{'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Davis', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Parker', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University, Bloomington, IN.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'Harvard Medical School/Massachusetts General Hospital, Department of Psychiatry, Boston, MA.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Priest', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, RI.'}, {'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz134']
2166,23162395,Effect of adding dexamethasone to bupivacaine on transversus abdominis plane block for abdominal hysterectomy: A prospective randomized controlled trial.,"PURPOSE
Different adjuvants have been used to improve the quality and increase the duration of local anesthetics during various nerve block techniques. The current study was aimed to evaluate the effect of adding dexamethasone to bupivacaine on the quality and duration of transversus abdominis plane (TAP) block.
METHODS
Sixty adult patients undergoing elective open abdominal hysterectomy were randomly allocated to receive TAP block using 20 mL of bupivacaine hydrochloride 0.25% + 2 mL saline 0.9% (control group, n=30) or 20 mL of bupivacaine hydrochloride 0.25% + 2 mL dexamethasone ""8 mg"" (dexamethasone group, n=30). The primary outcome was postoperative pain, as evaluated by visual analog scale (VAS) for pain scoring at 1, 2, 4, 12, 24 and 48 h postoperatively, whereas the secondary outcomes were time to first analgesia (TFA), morphine consumption and the occurrence of nausea, vomiting or somnolence.
RESULTS
The pain VAS score was significantly lower at the postoperative 2 h (4.9 vs. 28.1, P=0.01), 4 h (12.2 vs. 31.1, P=0.01) and 12 h (15.7 vs. 25.4, P=0.02). Furthermore, TFA was significantly longer in the dexamethasone group (459.8 vs. 325.4 min, P=0.002), with lesser morphine requirements in the postoperative 48 h (4.9 vs. 21.2 mg, P=0.003) and lower incidence of nausea and vomiting (6 vs. 14, P=0.03). No complications attributed to the block were recorded.
CONCLUSION
Addition of dexamethasone to bupivacaine in TAP block prolonged the duration of the block and decreased the incidence of nausea and vomiting.",2012,"The pain VAS score was significantly lower at the postoperative 2 h (4.9 vs. 28.1, P=0.01), 4 h (12.2 vs. 31.1, P=0.01) and 12 h (15.7 vs. 25.4, P=0.02).","['abdominal hysterectomy', 'Sixty adult patients undergoing elective open abdominal hysterectomy']","['bupivacaine', 'TAP block', 'bupivacaine hydrochloride 0.25% + 2 mL saline 0.9% (control group, n=30) or 20 mL of bupivacaine hydrochloride 0.25% + 2 mL dexamethasone ""8 mg"" (dexamethasone', 'dexamethasone']","['nausea and vomiting', 'quality and duration of transversus abdominis plane (TAP) block', 'TFA', 'postoperative pain, as evaluated by visual analog scale (VAS) for pain scoring', 'time to first analgesia (TFA), morphine consumption and the occurrence of nausea, vomiting or somnolence', 'pain VAS score', 'transversus abdominis plane block']","[{'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.110102,"The pain VAS score was significantly lower at the postoperative 2 h (4.9 vs. 28.1, P=0.01), 4 h (12.2 vs. 31.1, P=0.01) and 12 h (15.7 vs. 25.4, P=0.02).","[{'ForeName': 'Amany S', 'Initials': 'AS', 'LastName': 'Ammar', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Minoufiya University, Shebin El Kom, Minoufiya, Egypt.'}, {'ForeName': 'Khaled M', 'Initials': 'KM', 'LastName': 'Mahmoud', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101213']
2167,23162398,Comparison of the use of McCoy and TruView EVO2 laryngoscopes in patients with cervical spine immobilization.,"CONTEXT
The cervical spine has to be stabilized in patients with suspected cervical spine injury during laryngoscopy and intubation by manual in-line axial stabilization. This has the propensity to increase the difficulty of intubation. An attempt has been made to compare TruView EVO2 and McCoy with cervical spine immobilization, which will aid the clinician in choosing an appropriate device for securing the airway with an endotracheal tube (ETT) in the clinical scenario of trauma.
AIMS
To compare the effectiveness of TruView EVO2 and McCoy laryngoscopes when performing tracheal intubation in patients with neck immobilization using manual in-line axial cervical spine stabilization.
SETTINGS AND DESIGN
K. M. C. Hospital, Mangalore, This was a randomized control clinical trial.
METHODS
Sixty adult patients of either sex of ASA physical status 1 and 2 who were scheduled to undergo general anesthesia with endotracheal intubation were studied. Comparison of intubation difficulty score (IDS), hemodynamic response, Cormack and Lehane grade, duration of the tracheal intubation and rate of successful placement of the ETT in the trachea between TruView EVO2 and McCoy laryngoscopes was performed.
RESULTS
The results demonstrated that TruView has a statistically significant less IDS of 0.33 compared with an IDS of 1.2 for McCoy. TruView also had a better Cormack and Lehane glottic view (CL 1 of 77% versus 40%) and less hemodynamic response.
CONCLUSIONS
The TruView blade is a useful option for tracheal intubation in patients with suspected cervical spine injury.",2012,The results demonstrated that TruView has a statistically significant less IDS of 0.33 compared with an IDS of 1.2 for McCoy.,"['patients with suspected cervical spine injury during laryngoscopy and intubation by manual in-line axial stabilization', 'patients with neck immobilization using manual in-line axial cervical spine stabilization', 'patients with suspected cervical spine injury', 'patients with cervical spine immobilization', 'Sixty adult patients of either sex of ASA physical status 1 and 2 who were scheduled to undergo general anesthesia with endotracheal intubation were studied']","['TruView EVO2 and McCoy laryngoscopes', 'McCoy and TruView EVO2 laryngoscopes']","['intubation difficulty score (IDS), hemodynamic response, Cormack and Lehane grade, duration of the tracheal intubation and rate of successful placement of the ETT', 'hemodynamic response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C1301792', 'cui_str': 'Cervical spine immobilization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0456719', 'cui_str': 'Cormack and Lehane grade'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",60.0,0.0579689,The results demonstrated that TruView has a statistically significant less IDS of 0.33 compared with an IDS of 1.2 for McCoy.,"[{'ForeName': 'Jiju', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': 'Department of Anesthesiology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Sequeira', 'Affiliation': ''}, {'ForeName': 'Madhusudan', 'Initials': 'M', 'LastName': 'Upadya', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101216']
2168,23162399,To evaluate the efficacy of intrathecal magnesium sulphate for hysterectomy under subarachnoid block with bupivacaine and fentanyl: A prospective randomized double blind clinical trial.,"BACKGROUND
Intrathecal magnesium has been found to prolong the duration of analgesia in various surgical procedures like lower limb surgeries and as adjuncts to general anesthesia for pain management. The present study was designed to examine whether addition of intrathecal magnesium sulfate would enhance the analgesic efficacy of intrathecal bupivacaine and fentanyl in patients undergoing total abdominal hysterectomy.
METHODS
After taking informed consent, 60 patients were randomised into two groups with 30 patients. Group ""S"" received 2.5 mL (12.5 mg) of hyperbaric bupivacaine + 0.5 mL (25 mcg) of fentanyl + 0.5 mL of normal saline and Group ""M"" received 2.5 mL (12.5 mg) of hyperbaric bupivacaine + 0.5 mL (25 mcg) of fentanyl + 0.5 mL (100 mg) of magnesium sulfate. Onset of sensory, motor block and duration of analgesia was noted.
RESULTS
Demographic profile and duration of surgery were comparable (P>0.5). Time of onset of sensory and motor blockade was delayed in Group M compared with Group S, and this was statistically significant. A statistically significant longer duration of analgesia was observed in Group M compared with the control Group S. However, the recovery of motor blockade was found to be statistically insignificant in both the groups. The hemodynamic parameters were comparable in the perioperative period (P>0.05). The incidence of side-effects in both the groups were also comparable (P>0.05).
CONCLUSION
The addition of 100 mg intrathecal magnesium led to prolonged duration of analgesia significantly without increasing the incidence of side-effects. Also, there was a significant delay in the onset of both sensory and motor blockade.",2012,"Time of onset of sensory and motor blockade was delayed in Group M compared with Group S, and this was statistically significant.","['60 patients were randomised into two groups with 30 patients', 'patients undergoing total abdominal hysterectomy']","['fentanyl + 0.5 mL of normal saline', 'intrathecal magnesium sulfate', 'intrathecal magnesium sulphate', 'fentanyl + 0.5 mL', 'magnesium sulfate', 'intrathecal magnesium', 'bupivacaine and fentanyl', 'hyperbaric bupivacaine + 0.5 mL']","['prolonged duration of analgesia', 'Time of onset of sensory and motor blockade', 'analgesic efficacy', 'onset of both sensory and motor blockade', 'recovery of motor blockade', 'duration of analgesia', 'Onset of sensory, motor block and duration of analgesia', 'hemodynamic parameters', 'incidence of side-effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449244', 'cui_str': 'Time of onset (observable entity)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",60.0,0.232258,"Time of onset of sensory and motor blockade was delayed in Group M compared with Group S, and this was statistically significant.","[{'ForeName': 'Mridu Paban', 'Initials': 'MP', 'LastName': 'Nath', 'Affiliation': 'Department of Anesthesiology and Critical Care, Gauhati Medical College Hospital, Guwahati, Assam, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Talukdar', 'Affiliation': ''}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Choudhary', 'Affiliation': ''}, {'ForeName': 'Anulekha', 'Initials': 'A', 'LastName': 'Chakrabarty', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101217']
2169,23162401,Effects of preoperative β-blocker on blood loss and blood transfusion during spinal surgeries with sodium nitroprusside-controlled hypotension.,"BACKGROUND
The present study sought to determine whether premedication with oral β-blocker before hypotensive anesthesia with sodium nitroprusside could improve the quality of surgical field, decrease the blood loss, and decrease the need for homologous blood transfusion and duration of surgery.
METHODS
Eighty patients scheduled for spinal fixation surgery were included in a prospective, randomized, double-blinded study. Patients were classified into two groups: Group I received oral atenolol 50 mg twice one day before surgery; and Group II received placebo tablets identical in appearance to atenolol tablets for the same period and interval. All patients in both the groups received intraoperative sodium nitroprusside (SNP) as a hypotensive agent. Hemodynamic variables, amount of sodium nitroprusside used, quality of surgical field, and the amount of homologous blood transfusion and blood loss were compared between groups.
RESULTS
Heart rate and amount of SNP used were significantly less (P<0.0001) in the atenolol group, but no significant difference was found in intraoperative mean arterial blood pressure (MABP) between the two groups. The time of surgeries was significantly shorter in Group I than in Group II (185±15.21 vs 225±12.61 min), P<0.0001. The quality of surgical field was better in Group I than in Group II in all times of measurements, P<0.0001. The amount of blood loss and the amount of packed red blood cells transfused were significantly less in Group I than in Group II, P<0.0001. No clinically significant complications were observed in either group.
CONCLUSION
Premedication with oral atenolol 50 mg twice/day for one day before hypotensive anesthesia with SNP during spinal surgeries seems to be clinically safe and effective to reduce heart rate, amount of SNP used, amount of blood loss, and amount of blood transfused with better quality of surgical field.",2012,"The quality of surgical field was better in Group I than in Group II in all times of measurements, P<0.0001.","['Eighty patients scheduled for spinal fixation surgery', 'spinal surgeries with sodium nitroprusside-controlled hypotension']","['oral atenolol', 'intraoperative sodium nitroprusside (SNP', 'atenolol', 'sodium nitroprusside', 'placebo tablets identical in appearance to atenolol tablets', 'preoperative β-blocker']","['Heart rate and amount of SNP', 'blood loss and the amount of packed red blood cells transfused', 'quality of surgical field', 'blood loss', 'time of surgeries', 'blood loss and blood transfusion', 'Hemodynamic variables, amount of sodium nitroprusside used, quality of surgical field, and the amount of homologous blood transfusion and blood loss', 'intraoperative mean arterial blood pressure (MABP']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}]",80.0,0.0393193,"The quality of surgical field was better in Group I than in Group II in all times of measurements, P<0.0001.","[{'ForeName': 'Yasser Mohamed', 'Initials': 'YM', 'LastName': 'Amr', 'Affiliation': 'Department of Anesthesia, Tanta University, Egypt.'}, {'ForeName': 'Sabry M', 'Initials': 'SM', 'LastName': 'Amin', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101219']
2170,32421593,Familial severe psychiatric history in bipolar disorder and correlation with disease severity and treatment response.,"BACKGROUND
Bipolar disorder is a heritable disorder, and we aimed to assess the impact of family history of mental disorders in first-degree relatives on the severity and course of bipolar disorder.
METHODS
The Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium) comparative effectiveness studies were similar trials among bipolar disorder outpatients studying four different randomized treatment arms for 24 weeks. Patients self-reported on six severe mental disorders among first-degree relatives. We performed ANOVA and linear regression regarding disease severity measures, sociodemographic and cardiometabolic markers and mixed effects linear regression to evaluate treatment response.
RESULTS
Among 757 patients, 644 (85.1%) reported at least one first-degree relative with a severe mental disorder (mean=2.8; standard deviation=2.2; range=0-13). Depression (67.1%), alcohol abuse (51.0%) and bipolar disorder (47.0%) were the most frequently reported disorders. Familial psychiatric history correlated with several disease severity measures (hospitalizations, suicide attempts, and earlier onset) and sociodemographic markers (lower education and household income) but not with cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score. Patients with familial psychiatric history tended to require more psychopharmacological treatment (p=0.054) but responded similarly (all p>0.1) to all four treatment arms.
CONCLUSIONS
Our findings indicate that familial psychiatric history is common among outpatients with bipolar disorder and correlates with disease severity and sociodemographic measures. Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.",2020,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"['Patients with familial psychiatric history', 'bipolar disorder outpatients', 'outpatients with bipolar disorder']",['Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium'],"['severe mental disorder', 'Depression', 'cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score', 'bipolar disorder', 'alcohol abuse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse'}]",757.0,0.044469,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark; Department of Clinical Medicin, Aarhus University, Aarhus, Denmark; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: karkoe@rm.dk.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Ruberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Kuperberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alec P', 'Initials': 'AP', 'LastName': 'Shannon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Fung', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital; Department of Medicine, Harvard Medical School.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Overhage', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Friedman', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH and Lindner Center of HOPE, Mason, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.157']
2171,22906338,Irrigation with bupivacaine at the surgical bed for postoperative pain relief after laparoscopic cholecystectomy.,"PURPOSE
The aim of this study was to evaluate the effect of bupivacaine irrigated at the surgical bed on postoperative pain relief in laparoscopic cholecystectomy patients.
METHODS
This study included 60 patients undergoing elective laparoscopic cholecystectomy who were prospectively randomized into 2 groups. The placebo group (n=30) received 20cc saline without bupivacaine, installed into the gallbladder bed. The bupivacaine group (n=30) received 20cc of 0.5% bupivacaine in at the same surgical site. Pain was assessed at 0, 6, 12, and 24 hours by using a visual analog scale (VAS).
RESULTS
A significant difference (P=.018) was observed in pain levels between both groups at 6 hours postoperatively. The average analgesic requirement was lower in the bupivacaine group, but this did not reach statistical significance.
CONCLUSIONS
In our study, the use of bupivacaine irrigated over the surgical bed was an effective method for reducing pain during the first postoperative hours after laparoscopic cholecystectomy.",2012,"The average analgesic requirement was lower in the bupivacaine group, but this did not reach statistical significance.
","['60 patients undergoing elective laparoscopic cholecystectomy who', 'laparoscopic cholecystectomy patients', 'after laparoscopic cholecystectomy']","['20cc of 0.5% bupivacaine', '20cc saline without bupivacaine', 'placebo', 'bupivacaine']","['pain', 'average analgesic requirement', 'Pain', 'visual analog scale (VAS', 'pain levels', 'postoperative pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",60.0,0.0348252,"The average analgesic requirement was lower in the bupivacaine group, but this did not reach statistical significance.
","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Castillo-Garza', 'Affiliation': 'General Surgery, Tecnologico de Monterrey-Escuela de Medicina y Ciencias de la Salud. Postgraduate Area, Monterrey, N. L. México. dr.gcg@hotmail.com'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Díaz-Elizondo', 'Affiliation': ''}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Cuello-García', 'Affiliation': ''}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Villegas-Cabello', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680812X13291597716221']
2172,22754437,Cardioprotective effect of sevoflurane in patients with coronary artery disease undergoing vascular surgery.,"OBJECTIVES
The present study was conducted to evaluate the cardioprotective effect of sevoflurane compared with propofol in patients with coronary artery disease (CAD) undergoing peripheral vascular surgery; and to address the question whether a volatile anesthetic might improve cardiac outcome in these patients.
METHODS
One hundred twenty-six patients scheduled for elective peripheral vascular surgery were prospectively randomized to receive either sevoflurane inhalation anesthesia or total intravenous anesthesia. ST-segment monitoring was performed continuously during intra- and post-operative 48 h periods. The number of ischemic events and the cumulative duration of ischemia in each patient were recorded. Blood was sampled in all patients for the determination of cTnI. Samples were obtained before the induction of anesthesia, on admission to the ICU, and at 6, 12, 24, and 48 h after admission to the intensive care unit (ICU). Patients were followed-up during their hospital stay for any adverse cardiac events.
RESULTS
The incidence of ischemia were comparable among the groups [16 (25%) patients in sevoflurane group vs 24 (39%) patients in propofol group; P=0.126]. Duration, cumulative duration, and magnitude of ST-segment depression of ischemic events in each patient were significantly less in sevoflurane group (P=0.008, 0.048, 0.038, respectively). cTnI levels of the overall population were significantly less in sevoflurane group vs propofol group (P values <0.0001) from 6 h postoperative and onward. Meanwhile, cTnI levels at 6, 12, 24, and 48 h after admission to the ICU in patients who presented with ischemic electrocardiographic (ECG) changes were significantly lower in sevoflurane group than in the propofol group (P<0.0001, <0.0001, <0.0001, 0.0003). None of the patients presented with unstable angina, myocardial infarction, congestive heart failure, or serious arrhythmia either during ICU or hospital stay.
CONCLUSION
Patients with CAD receiving sevoflurane for peripheral vascular surgery had significantly lower release of cardiac troponin I at 6 h postoperatively and lasting for 48 h than patients receiving propofol for the same procedure with significant decrease in duration, cumulative duration of ischemic events, and degree of ST depression in each patient.",2012,levels of the overall population were significantly less in sevoflurane group vs propofol group (P values <0.0001) from 6 h postoperative and onward.,"['patients with coronary artery disease undergoing vascular surgery', 'patients with coronary artery disease (CAD) undergoing peripheral vascular surgery', 'patients presented with unstable angina, myocardial infarction, congestive heart failure, or serious arrhythmia either during ICU or hospital stay', 'One hundred twenty-six patients scheduled for elective peripheral vascular surgery', 'Patients with CAD receiving']","['propofol', 'sevoflurane inhalation anesthesia or total intravenous anesthesia', 'sevoflurane', 'cTnI']","['number of ischemic events and the cumulative duration of ischemia', 'levels of the overall population', 'cardiac troponin', 'duration, cumulative duration of ischemic events, and degree of ST depression', 'ischemic electrocardiographic (ECG) changes', 'incidence of ischemia', 'Meanwhile, cTnI levels', 'Duration, cumulative duration, and magnitude of ST-segment depression of ischemic events', 'cardioprotective effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002917', 'cui_str': 'Anesthesia, Inhalation'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0520887', 'cui_str': 'ST segment depression (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",126.0,0.0665445,levels of the overall population were significantly less in sevoflurane group vs propofol group (P values <0.0001) from 6 h postoperative and onward.,"[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Bassuoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, Tanta University, Egypt.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Amr', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.97024']
2173,22754438,Spectral entropy as an objective measure of sedation state in midazolam-premedicated patients.,"CONTEXT
Objective assessment of sedation depth is a valuable target. Spectral entropy is an anesthetic depth monitor based on the analysis of the electroencephalogram signal.
AIMS
To evaluate the performance of spectral entropy as an objective measure of sedation state in midazolam-premedicated patients and to correlate it with a clinically assessed sedation score.
SETTINGS AND DESIGN
This prospective double-blind placebo-controlled study was performed in King Fahd Hospital of the university.
METHODS
Eighty adult ASA I-II patients were randomly assigned into 4 groups. Patients were premedicated using 0.02, 0.04, or 0.06 mg/kg midazolam or saline intramuscularly. The effect of these doses on the Observer's Assessment of Alertness and Sedation (OAA/S) scale, hemodynamic variables, response entropy (RE), and state entropy (SE), was evaluated at 10, 20, and 30 min after premedication.
STATISTICAL ANALYSIS
Spearman Rank-order correlation analysis to examine the relation between OAA/S and entropy. The ability of spectral entropy to predict the depth of sedation was evaluated using Smith prediction probability.
RESULTS
Midazolam doses ≥0.04 mg/kg produced significant decreases in RE, SE, and OAA/S scores. There was a strong correlation between midazolam dose and OAA/S scale, RE, and SE since Spearman Rank R values were 0.792, 0.822, and 0.745, respectively (P<0.001). In addition, RE and SE were strong predictors of OAA/S level during midazolam sedation with no significant difference in prediction between the 2 entropy components.
CONCLUSIONS
Spectral entropy is a reliable measure for the sedative premedication. It may be used to objectively assess the adequacy of midazolam premedication and to determine the dose requirement.",2012,"Midazolam doses ≥0.04 mg/kg produced significant decreases in RE, SE, and OAA/S scores.","['King Fahd Hospital of the university', 'premedicated patients', 'Eighty adult ASA']","['placebo', 'midazolam', 'Midazolam']","[""Observer's Assessment of Alertness and Sedation (OAA/S) scale, hemodynamic variables, response entropy (RE), and state entropy (SE"", 'OAA/S scale, RE, and SE since Spearman Rank R values', 'RE, SE, and OAA/S scores', 'sedation state', 'OAA/S level']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",80.0,0.318023,"Midazolam doses ≥0.04 mg/kg produced significant decreases in RE, SE, and OAA/S scores.","[{'ForeName': 'Hany A', 'Initials': 'HA', 'LastName': 'Mowafi', 'Affiliation': 'Department of Anaesthesia, Faculty of Medicine, King Faisal University, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.97025']
2174,22754440,"Effects of addition of ketamine, fentanyl and saline with Propofol induction on hemodynamics and laryngeal mask airway insertion conditions in oral clonidine premedicated children.","BACKGROUND
The aim of this double-blind, prospective, randomized, controlled study was to compare the effect of addition of ketamine; fentanyl and saline with propofol anesthesia on hemodynamic profile and laryngeal mask airway (LMA) insertion conditions in oral clonidine premedicated children.
METHODS
180 children (age 2 - 10 years) were at first given oral clonidine (4 μg/kg) 90 minutes before operation, and then were randomly allocated to receive either ketamine 0.5 mg/kg (n=60), fentanyl 1 μg/kg (n=60) or 0.9% normal saline (n=60) before induction with propofol 3.0 mg/kg. Insertion of LMA was performed within 1 minute of injection of propofol. Heart rate and mean blood pressure were noted 1 min before induction (baseline), immediately after induction, before and after insertion of LMA for up to 3 min. Following LMA insertion, 6 subjective end points were noted-mouth opening, coughing, swallowing, patient's movement, laryngospasm, and ease of an insertion. LMA insertion summed score was prepared depending upon these variables.
RESULTS
LMA insertion summed score was nearly similar in ketamine and fentanyl group, which were significantly better than saline group (P<0.004). Mean blood pressure and heart rate were maintained in ketamine than with fentanyl or saline group. Incidence of prolonged apnea (>120 secs.) was higher in fentanyl group compared to ketamine and saline group.
CONCLUSION
Even in oral clonidine premedicated children, addition of ketamine with propofol provides hemodynamic stability and comparable conditions for LMA insertion like fentanyl propofol with significantly less prolonged apnea.",2012,"Incidence of prolonged apnea (>120 secs.) was higher in fentanyl group compared to ketamine and saline group.
","['180 children (age 2 - 10 years', 'premedicated children', 'oral clonidine premedicated children']","['fentanyl 1 μg/kg (n=60) or 0.9% normal saline', 'fentanyl or saline', 'ketamine, fentanyl and saline with Propofol induction', 'ketamine; fentanyl and saline with propofol anesthesia', 'propofol', 'clonidine', 'propofol 3.0 mg/kg', 'ketamine', 'oral clonidine', 'ketamine with propofol', 'LMA']","['hemodynamic profile and laryngeal mask airway ', 'Incidence of prolonged apnea', 'Mean blood pressure and heart rate', 'hemodynamics and laryngeal mask airway insertion conditions', 'prolonged apnea', ""mouth opening, coughing, swallowing, patient's movement, laryngospasm, and ease of an insertion"", 'Heart rate and mean blood pressure']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0396618', 'cui_str': 'Laryngeal mask airway insertion (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",180.0,0.279114,"Incidence of prolonged apnea (>120 secs.) was higher in fentanyl group compared to ketamine and saline group.
","[{'ForeName': 'Tanmoy', 'Initials': 'T', 'LastName': 'Ghatak', 'Affiliation': 'Department of Critical Care Medicine, SGPGIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Rajni', 'Initials': 'R', 'LastName': 'Kapoor', 'Affiliation': ''}, {'ForeName': 'Jaishree', 'Initials': 'J', 'LastName': 'Bogra', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.97027']
2175,22754441,Prophylactic administration of haloperidol plus midazolam reduces postoperative nausea and vomiting better than using each drug alone in patients undergoing middle ear surgery.,"AIMS
The efficacy of using midazolam or haloperidol for prevention of postoperative nausea and vomiting (PONV) has been investigated before. The main object of the present study was to evaluate the anti-emetic effects of combining administration of intravenous haloperidol with intravenous midazolam on PONV in patients underwent middle ear surgery in comparison with using each drug alone.
METHODS
Study design was randomized, double-blind, placebo-controlled. 80 patients, aged 18-60 years, scheduled for middle ear surgery in Kashani Hospital Medical Center under general anesthesia were enrolled in this randomized, double-blind, placebo-controlled study. Patients were divided into 4 groups of 20 each and received haloperidol 2 mg i.v. (Group H); midazolam 2 mg i.v. (Group M); haloperidol 2 mg plus midazolam 2 mg i.v. (Group HM); saline i.v. (Group C). The incidences of PONV and complete response were evaluated at 0-2 hours after arrival to the PACU and 2-24 hours after arrival to the ward in 4 groups.
RESULTS
Patients in group HM had significantly lower incidence of PONV compared with groups H, M, and C throughout 0-24 h (P<00.5). The HM group had the lowest incidence of PONV (0-2, 2-24, and 0-24 h) and the highest incidence of complete response. Postoperative anti-emetic requirement was significantly less in group HM compared with group M or H (P<0.05).
CONCLUSION
Combine administration of haloperidol 2 mg plus midazolam 2 mg significantly reduced PONV better than using each drug alone in patients underwent middle ear surgery under general anesthesia.",2012,"Postoperative anti-emetic requirement was significantly less in group HM compared with group M or H (P<0.05).
","['Patients in group', '80 patients, aged 18-60 years, scheduled for middle ear surgery in Kashani Hospital Medical Center under general anesthesia', 'patients underwent middle ear surgery under general anesthesia', 'patients undergoing middle ear surgery', 'patients underwent middle ear surgery in comparison with using each drug alone']","['placebo', 'midazolam', 'midazolam or haloperidol', 'haloperidol plus midazolam', 'haloperidol', 'haloperidol 2 mg i.v', 'haloperidol 2 mg plus midazolam']","['postoperative nausea and vomiting better', 'incidences of PONV and complete response', 'postoperative nausea and vomiting (PONV', 'Postoperative anti-emetic requirement', 'incidence of PONV', 'PONV better', 'lowest incidence of PONV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0986407', 'cui_str': 'Haloperidol 2 MG'}]","[{'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",80.0,0.195709,"Postoperative anti-emetic requirement was significantly less in group HM compared with group M or H (P<0.05).
","[{'ForeName': 'Azim', 'Initials': 'A', 'LastName': 'Honarmand', 'Affiliation': 'Departments of Anesthesiology and Critical Care, Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Safavi', 'Affiliation': ''}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Khalili', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohammadnejad', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.97028']
2176,32493111,A randomized controlled trial of dorsal web space versus palmar midline injection of steroid in the treatment of trigger digits.,"One hundred and sixty patients were enrolled in a prospective randomized controlled trial to assess whether a steroid injection through the dorsal web space was less painful than the palmar midline technique in the treatment of trigger digits and whether they were equally effective. There were 116 women and 44 men with a mean age of 60 years. The mean visual analogue score for pain during the injection was 3.6 in the dorsal web space group and 5.4 in the palmar midline group on a scale of 0-10. The overall success of treatment in the dorsal group was 67%, whereas it was 56% in the palmar group. No complications were noted. We concluded from this study that the dorsal web space technique is less painful and at least as effective as the palmar midline technique. Level of evidence: I.",2020,"The overall success of treatment in the dorsal group was 67%, whereas it was 56% in the palmar group.","['One hundred and sixty patients', '116 women and 44 men with a mean age of 60 years', 'trigger digits']","['dorsal web space versus palmar midline injection of steroid', 'steroid injection']","['mean visual analogue score for pain', 'overall success']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0158328', 'cui_str': 'Trigger finger'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1184147', 'cui_str': 'Palmar'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",160.0,0.0543586,"The overall success of treatment in the dorsal group was 67%, whereas it was 56% in the palmar group.","[{'ForeName': 'Isidro', 'Initials': 'I', 'LastName': 'Jiménez', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Gerardo L', 'Initials': 'GL', 'LastName': 'Garcés', 'Affiliation': 'School of Medicine. Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marcos-García', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Medina', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420927999']
2177,23149426,"Stress reduction in the secondary prevention of cardiovascular disease: randomized, controlled trial of transcendental meditation and health education in Blacks.","BACKGROUND
Blacks have disproportionately high rates of cardiovascular disease. Psychosocial stress may contribute to this disparity. Previous trials on stress reduction with the Transcendental Meditation (TM) program have reported improvements in cardiovascular disease risk factors, surrogate end points, and mortality in blacks and other populations.
METHODS AND RESULTS
This was a randomized, controlled trial of 201 black men and women with coronary heart disease who were randomized to the TM program or health education. The primary end point was the composite of all-cause mortality, myocardial infarction, or stroke. Secondary end points included the composite of cardiovascular mortality, revascularizations, and cardiovascular hospitalizations; blood pressure; psychosocial stress factors; and lifestyle behaviors. During an average follow-up of 5.4 years, there was a 48% risk reduction in the primary end point in the TM group (hazard ratio, 0.52; 95% confidence interval, 0.29-0.92; P=0.025). The TM group also showed a 24% risk reduction in the secondary end point (hazard ratio, 0.76; 95% confidence interval, 0.51-0.1.13; P=0.17). There were reductions of 4.9 mmHg in systolic blood pressure (95% confidence interval -8.3 to -1.5 mmHg; P=0.01) and anger expression (P<0.05 for all scales). Adherence was associated with survival.
CONCLUSIONS
A selected mind-body intervention, the TM program, significantly reduced risk for mortality, myocardial infarction, and stroke in coronary heart disease patients. These changes were associated with lower blood pressure and psychosocial stress factors. Therefore, this practice may be clinically useful in the secondary prevention of cardiovascular disease. Clinical Trial Registration- URL: www.clinicaltrials.gov Unique identifier: NCT01299935.",2012,"A selected mind-body intervention, the TM program, significantly reduced risk for mortality, myocardial infarction, and stroke in coronary heart disease patients.","['coronary heart disease patients', '201 black men and women with coronary heart disease', 'Blacks']","['TM program or health education', 'transcendental meditation and health education', 'Transcendental Meditation (TM) program']","['systolic blood pressure', 'risk for mortality, myocardial infarction, and stroke', 'composite of cardiovascular mortality, revascularizations, and cardiovascular hospitalizations; blood pressure; psychosocial stress factors; and lifestyle behaviors', 'survival', 'anger expression', 'composite of all-cause mortality, myocardial infarction, or stroke', 'blood pressure and psychosocial stress factors']","[{'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018701'}, {'cui': 'C0150814', 'cui_str': 'Transcendental Meditation'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",201.0,0.30288,"A selected mind-body intervention, the TM program, significantly reduced risk for mortality, myocardial infarction, and stroke in coronary heart disease patients.","[{'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schneider', 'Affiliation': 'Institute for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA, USA.'}, {'ForeName': 'Clarence E', 'Initials': 'CE', 'LastName': 'Grim', 'Affiliation': ''}, {'ForeName': 'Maxwell V', 'Initials': 'MV', 'LastName': 'Rainforth', 'Affiliation': ''}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Kotchen', 'Affiliation': ''}, {'ForeName': 'Sanford I', 'Initials': 'SI', 'LastName': 'Nidich', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Gaylord-King', 'Affiliation': ''}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Salerno', 'Affiliation': ''}, {'ForeName': 'Jane Morley', 'Initials': 'JM', 'LastName': 'Kotchen', 'Affiliation': ''}, {'ForeName': 'Charles N', 'Initials': 'CN', 'LastName': 'Alexander', 'Affiliation': ''}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.112.967406']
2178,31867653,Potential Moderating Effects of Psychiatric Diagnosis and Symptom Severity on Subjective and Behavioral Responses to Reduced Nicotine Content Cigarettes.,"INTRODUCTION
Given FDA's authority to implement a cigarette nicotine reduction policy, possible outcomes of this regulation must be examined, especially among those who may be most affected, such as those with comorbid psychiatric disorders.
METHODS
In this secondary analysis of a multisite, randomized, clinical laboratory study, we used analyses of variance to examine the effects of nicotine dose (0.4, 2.4, 5.2, and 15.8 mg/g of tobacco), depressive and anxiety diagnoses (depression only, anxiety only, both, or neither), and depressive and anxiety symptom severity on cigarette choice, smoke exposure, craving, and withdrawal across three vulnerable populations: socioeconomically disadvantaged women of reproductive age, opioid-dependent individuals, and those with affective disorders (n = 169).
RESULTS
Diagnosis and symptom severity largely had no effects on smoking choice, total puff volume, or CO boost. Significant main effects on craving and withdrawal were observed, with higher scores in those with both anxiety and depression diagnoses compared with depression alone or no diagnosis, and in those with more severe depressive symptoms (p's < .001). These factors did not interact with nicotine dose. Cigarettes with <15.8 mg/g nicotine were less reinforcing, decreased total puff volume, and produced significant but lower magnitude and shorter duration reductions in craving and withdrawal than higher doses (p's < .01).
CONCLUSIONS
Reducing nicotine dose reduced measures of cigarette addiction potential, with little evidence of moderation by either psychiatric diagnosis or symptom severity, providing evidence that those with comorbid psychiatric disorders would respond to a nicotine reduction policy similarly to other smokers.
IMPLICATIONS
Thus far, controlled studies in healthy populations of smokers have demonstrated that use of very low nicotine content cigarettes reduces cigarette use and dependence without resulting in compensatory smoking. These analyses extend those findings to a vulnerable population of interest, those with comorbid psychiatric disorders. Cigarettes with very low nicotine content were less reinforcing, decreased total puff volume, and produced significant but lower magnitude and shorter duration reductions in craving and withdrawal than higher doses. These nicotine dose effects did not interact with psychiatric diagnosis or mood symptom severity suggesting that smokers in this vulnerable population would respond to a nicotine reduction strategy similarly to other smokers.",2019,"Reducing nicotine dose reduced measures of cigarette addiction potential, with little evidence of moderation by either psychiatric diagnosis or symptom severity, providing evidence that those with comorbid psychiatric disorders would respond to a nicotine reduction policy similarly to other smokers.
","['healthy populations of smokers', 'across three vulnerable populations: socioeconomically disadvantaged women of reproductive age, opioid-dependent individuals, and those with affective disorders (n = 169']","['nicotine', 'Nicotine Content Cigarettes']","['depressive and anxiety diagnoses (depression only, anxiety only, both, or neither), and depressive and anxiety symptom severity on cigarette choice, smoke exposure, craving, and withdrawal', 'severe depressive symptoms', 'Psychiatric Diagnosis and Symptom Severity on Subjective and Behavioral Responses', 'smoking choice, total puff volume, or CO boost', 'total puff volume', 'craving and withdrawal']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0376338', 'cui_str': 'Diagnosis, Psychiatric'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",3.0,0.0250267,"Reducing nicotine dose reduced measures of cigarette addiction potential, with little evidence of moderation by either psychiatric diagnosis or symptom severity, providing evidence that those with comorbid psychiatric disorders would respond to a nicotine reduction policy similarly to other smokers.
","[{'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, RI.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Davis', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Desarno', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont, Burlington, VT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz139']
2179,22808589,"You can take the eyes out of the doll, but....","The perceived animacy of a face is well-predicted by the perceived animacy of the eyes presented in isolation. This is not true for other facial features (eg having a highly life-like nose does not appear to be crucial), suggesting that the eyes are a critical feature for perceiving life in a face. Here, we asked whether it was therefore possible to 'transplant' animacy into a face by transplanting the eyes into a face image. We conducted digital eye surgery on a series of morphed human/doll faces and found that while doll eyes make a morphed face look less alive, human eyes do not make you look more so. Thus, we cannot so easily transplant animacy into a face, but we can take it away.",2012,"Here, we asked whether it was therefore possible to 'transplant' animacy into a face by transplanting the eyes into a face image.",[],['digital eye surgery'],[],[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}]",[],,0.0184246,"Here, we asked whether it was therefore possible to 'transplant' animacy into a face by transplanting the eyes into a face image.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Balas', 'Affiliation': 'Department of Psychology, North Dakota State University, Fargo, ND 58105, USA. benjamin.balas@ndsu.edu'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Horski', 'Affiliation': ''}]",Perception,[]
2180,32493088,"A Randomized, Placebo-Controlled Trial Evaluating Changes in Peripheral Neuropathy and Quality of Life by Using Low-Frequency Electrostimulation on Breast Cancer Patients Treated With Chemotherapy.","Background: This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer. Methods: A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN). Results: No differences in NRS scores were found between the patients in the ES and the SES group ( P = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES P < .001; SES P < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group ( P = .006). Conclusion: Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible.",2020,"No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B.","['72 patients newly diagnosed with CIPN', 'patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer', 'Breast Cancer Patients Treated With Chemotherapy']","['Placebo', 'Duloxetine or pregabalin', 'portable low-frequency electrostimulation (ES) device', 'sham ES', 'Low-Frequency Electrostimulation', 'placebo']","['CIPN intensities', 'TNS, EORTC-QLQ, CIPN20, and FACT-B', 'overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS', 'Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast', 'NRS scores', 'Peripheral Neuropathy and Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0045733', 'cui_str': '2-(4-toluidino)-6-naphthalenesulfonic acid'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4727882', 'cui_str': 'Total neuropathy score'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]",72.0,0.150093,"No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B.","[{'ForeName': 'Si-Yeon', 'Initials': 'SY', 'LastName': 'Song', 'Affiliation': 'Dunsan Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Ji-Hye', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Seoul Korean Medicine Hospital of Daejeon University, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Sun', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Je Ryong', 'Initials': 'JR', 'LastName': 'Kim', 'Affiliation': 'Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Eun Hee', 'Initials': 'EH', 'LastName': 'Sohn', 'Affiliation': 'Chungnam National University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Mi Sook', 'Initials': 'MS', 'LastName': 'Jung', 'Affiliation': 'Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Hwa-Seung', 'Initials': 'HS', 'LastName': 'Yoo', 'Affiliation': 'Seoul Korean Medicine Hospital of Daejeon University, Seoul, Republic of Korea.'}]",Integrative cancer therapies,['10.1177/1534735420925519']
2181,32493115,Will high-dose heparin affect blood loss and inflammatory response in patients undergoing cardiopulmonary bypass?,"INTRODUCTION
We performed a randomized study to investigate if a high versus a standard dose of heparin dose during cardiopulmonary bypass could affect intra- and post-operative bleeding and reduce the inflammatory response.
METHODS
A total of 30 patients undergoing elective coronary artery bypass grafting were randomized into high or standard dose of heparin during cardiopulmonary bypass. Blood loss was documented peri- and post-operatively, and interleukin-6, tumor necrosis factor-α, and C3 were measured in conjunction with cardiopulmonary bypass.
RESULTS
Data from 29 patients were analyzed after exclusion of one patient. The mean initial bolus and total heparin doses were 43,000 ± 5,800 IU versus 35,000 ± 4,100 IU, (p < 0.001), and 58,000 ± 9,500 IU versus 45,000 ± 7,900 IU, (p < 0.001) in the intervention and the control group, respectively. The median intra-operative bleeding was 150 mL (interquartile range 100-325) in the control versus 225 mL (IQR 200-350) in the intervention group, p = 0.15. The median chest tube blood loss 12 hour post-operatively was 300 mL (interquartile range 250-385) in the control versus 450 mL (IQR 315-505) in the intervention group, p = 0.029. There was no significant difference between the control group and the intervention group during cardiopulmonary bypass for the measured inflammatory markers interleukin-6 (p = 0.98), tumor necrosis factor-α (p = 0.72), or C3 (p = 0.13).
CONCLUSION
This small study showed a small increase of post-operative bleeding associated with higher heparin dosage in conjunction with cardiopulmonary bypass but did not demonstrate an effect of heparin on the inflammatory response to cardiopulmonary bypass.",2020,"The median intra-operative bleeding was 150 mL (interquartile range 100-325) in the control versus 225 mL (IQR 200-350) in the intervention group, p = 0.15.","['29 patients were analyzed after exclusion of one patient', 'patients undergoing cardiopulmonary bypass', '30 patients undergoing elective coronary artery bypass grafting']",['heparin'],"['median intra-operative bleeding', 'tumor necrosis factor-α ', 'median chest tube blood loss', 'blood loss and inflammatory response', 'inflammatory markers interleukin-6', 'Blood loss', 'mean initial bolus and total heparin doses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]",30.0,0.0961332,"The median intra-operative bleeding was 150 mL (interquartile range 100-325) in the control versus 225 mL (IQR 200-350) in the intervention group, p = 0.15.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Braatz', 'Affiliation': 'Department of Perioperative Medicine & Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Vanja', 'Initials': 'V', 'LastName': 'Sesartic', 'Affiliation': 'Department of Perioperative Medicine & Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Liska', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.'}]",Perfusion,['10.1177/0267659120924917']
2182,22643511,Preoperative warm-up using a virtual reality simulator.,"BACKGROUND AND OBJECTIVES
All modern surgical procedures require a high level of cognitive and psychomotor skills achieved using different training methods, but could be influenced by fatigue and other psychological factors. We evaluated the effect of warm-up exercises on operative laparoscopic performances.
METHODS
The surgical team operated on a consecutive series of 20 patients with gallstones. Patients were randomly allocated in 2 groups: group A to be operated on without warm-up exercises and group B to be operated on after a short-term warm-up. All the patients were operated on by the same surgical team. The full-time records of the operation were analyzed by 2 independent reviewers. A modified simplified Global Rating Score (GRS) was used to assess the surgical procedures. A training module using the Lap Mentor simulator was designed for the warm-up.
RESULTS
Better performances were noted by both observers in group B only regarding ""Respect for tissue"" scores (3.75 0.16 vs 4.43 0.20, P=.021 and 3.87 0.22 vs 4.57 0.20, P=.041) achieving significant or marginally significant differences for all categories; GRS scores for ""time and motion"" and ""overall impression"" tend to be better after warm-up, but differences failed to reach statistical significance in our series.
CONCLUSION
Surgeons, even the most experienced in laparoscopic surgery, can increase specific psychomotor skills associated with a laparoscopic environment by doing simple exercises on a virtual reality simulator, just before an operation. These improvements are reflected in more accurate handling of tissue during laparoscopic cholecystectomy.",2011,"RESULTS
Better performances were noted by both observers in group B only regarding ""Respect for tissue"" scores (3.75 0.16 vs 4.43 0.20, P=.021 and 3.87 0.22 vs 4.57 0.20, P=.041) achieving significant or marginally significant differences for all categories; GRS scores for ""time and motion"" and ""overall impression"" tend to be better after warm-up, but differences failed to reach statistical significance in our series.
",['20 patients with gallstones'],"['warm-up exercises', 'Preoperative warm-up using a virtual reality simulator']","['GRS scores for ""time and motion"" and ""overall impression', 'tissue"" scores', 'simplified Global Rating Score (GRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0947622', 'cui_str': 'Cholecystolithiasis'}]","[{'cui': 'C2350169', 'cui_str': 'Warmup Exercise'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",20.0,0.0169525,"RESULTS
Better performances were noted by both observers in group B only regarding ""Respect for tissue"" scores (3.75 0.16 vs 4.43 0.20, P=.021 and 3.87 0.22 vs 4.57 0.20, P=.041) achieving significant or marginally significant differences for all categories; GRS scores for ""time and motion"" and ""overall impression"" tend to be better after warm-up, but differences failed to reach statistical significance in our series.
","[{'ForeName': 'Radu', 'Initials': 'R', 'LastName': 'Moldovanu', 'Affiliation': 'University of Medicine and Pharmacy Gr.T. Popa Iasi, Romania. rmoldovanu@gmail.com'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Târcoveanu', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Dimofte', 'Affiliation': ''}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Lupaşcu', 'Affiliation': ''}, {'ForeName': 'Costel', 'Initials': 'C', 'LastName': 'Bradea', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680811X13176785204409']
2183,32492988,"A randomized trial comparing the acute coronary, systemic, and environmental effects of electronic vaping cigarettes versus heat-not-burn cigarettes in smokers of combustible cigarettes undergoing invasive coronary assessment: rationale and design of the SUR-VAPES 3 trial.","BACKGROUND
Traditional combustible cigarette (TCC) smoking remains a major cause of preventable cardiovascular morbidity and mortality. Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) may be safer than TCC but may still have detrimental oxidative, platelet and vascular effects of particular importance to people with symptomatic coronary artery disease (CAD).
METHODS
We aim to compare the acute coronary, systemic and environmental effects of two leading MRP in 20 TCC smokers admitted for invasive coronary assessment of CAD and willing to quit or after prior failed quitting attempts. After confirmation at angiography of an intermediate coronary stenosis, coronary flow reserve (CFR) will be appraised. Patients will then be randomized 1:1 to use a single EVC or a single HNBC in the catheterization laboratory, followed by repeat CFR measurement. The primary endpoint will be the change in CFR before and after product use. Quantitative coronary angiography, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR) will also be measured.
EXPECTED RESULTS
We expect to accrue results able to: 1) test whether MRP have in general a detrimental impact on coronary vascular function in TCC smokers; 2) test whether EVC have a different impact than HNBC on coronary function; 3) provide ancillary pathophysiologic and translational insights on the acute risk and safety profile of MRP in TCC smokers with established cardiovascular disease, including complex correlations between coronary, cardiac, systemic and environmental effects. In addition, by directly informing participants of their individual results, they will be further empowered to quit TCC.
CONCLUSIONS
The Sapienza University of Rome-Vascular Assessment of Proatherosclerotic Effects of Smoking (SUR-VAPES) 3 trial will provide important insights into the pathophysiologic cardiovascular impact of EVC and HNBC, also suitable to inform patients and individualize their smoking cessation strategy.",2020,"Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) may be safer than TCC but may still have detrimental oxidative, platelet and vascular effects of particular importance to people with symptomatic coronary artery disease (CAD).
","['smokers of combustible cigarettes undergoing invasive coronary assessment', 'people with symptomatic coronary artery disease (CAD', '20 TCC smokers admitted for invasive coronary assessment of CAD and willing to quit or after prior failed quitting attempts']","['electronic vaping cigarettes versus heat-not-burn cigarettes', 'MRP', 'EVC', 'Smoking (SUR-VAPES', 'TCC', 'Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC']","['change in CFR', 'Quantitative coronary angiography, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0455956', 'cui_str': 'Cigarette burn'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",20.0,0.183359,"Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) may be safer than TCC but may still have detrimental oxidative, platelet and vascular effects of particular importance to people with symptomatic coronary artery disease (CAD).
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi-Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy - giuseppe.biondizoccai@uniroma1.it.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carnevale', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vitali', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Tritapepe', 'Affiliation': 'UOC Anestesia e Rianimazione, AO San Camillo-Forlanini, Rome, Italy.'}, {'ForeName': 'Ombretta', 'Initials': 'O', 'LastName': 'Martinelli', 'Affiliation': 'Vascular Surgery Department, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Macrina', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Peruzzi', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cavarretta', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Antonino G', 'Initials': 'AG', 'LastName': 'Marullo', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Pauley Heart Center, Wright Center for Clinical and Translation Research, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Romagnoli', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Sciarretta', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Casati', 'Affiliation': 'UOC UTIC Emodinamica e Cardiologia, Ospedale Santa Maria Goretti, Latina, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Visconti', 'Affiliation': 'Direzione Sanitaria, ASL Latina, Latina, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Versaci', 'Affiliation': 'UOC UTIC Emodinamica e Cardiologia, Ospedale Santa Maria Goretti, Latina, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Frati', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.'}]",Minerva cardioangiologica,['10.23736/S0026-4725.20.05181-6']
2184,31860107,Effect of Teaching Bayesian Methods Using Learning by Concept vs Learning by Example on Medical Students' Ability to Estimate Probability of a Diagnosis: A Randomized Clinical Trial.,"Importance
Clinicians use probability estimates to make a diagnosis. Teaching students to make more accurate probability estimates could improve the diagnostic process and, ultimately, the quality of medical care.
Objective
To test whether novice clinicians can be taught to make more accurate bayesian revisions of diagnostic probabilities using teaching methods that apply either explicit conceptual instruction or repeated examples.
Design, Setting, and Participants
A randomized clinical trial of 2 methods for teaching bayesian updating and diagnostic reasoning was performed. A web-based platform was used for consent, randomization, intervention, and testing of the effect of the intervention. Participants included 61 medical students at McMaster University and Eastern Virginia Medical School recruited from May 1 to September 30, 2018.
Interventions
Students were randomized to (1) receive explicit conceptual instruction regarding diagnostic testing and bayesian revision (concept group), (2) exposure to repeated examples of cases with feedback regarding posttest probability (experience group), or (3) a control condition with no conceptual instruction or repeated examples.
Main Outcomes and Measures
Students in all 3 groups were tested on their ability to update the probability of a diagnosis based on either negative or positive test results. Their probability revisions were compared with posttest probability revisions that were calculated using the Bayes rule and known test sensitivity and specificity.
Results
Of the 61 participants, 22 were assigned to the concept group, 20 to the experience group, and 19 to the control group. Approximate age was 25 years. Two participants were first-year; 37, second-year; 12, third-year; and 10, fourth-year students. Mean (SE) probability estimates of students in the concept group were statistically significantly closer to calculated bayesian probability than the other 2 groups (concept, 0.4%; [0.7%]; experience, 3.5% [0.7%]; control, 4.3% [0.7%]; P < .001). Although statistically significant, the differences between groups were relatively modest, and students in all groups performed better than expected, based on prior reports in the literature.
Conclusions and Relevance
The study showed a modest advantage for students who received theoretical instruction on bayesian concepts. All participants' probability estimates were, on average, close to the bayesian calculation. These findings have implications for how to teach diagnostic reasoning to novice clinicians.
Trial Registration
ClinicalTrials.gov identifier: NCT04130607.",2019,"Mean (SE) probability estimates of students in the concept group were statistically significantly closer to calculated bayesian probability than the other 2 groups (concept, 0.4%; [0.7%]; experience, 3.5% [0.7%]; control, 4.3% [0.7%]; P < .001).","['61 participants', 'Participants included 61 medical students at McMaster University and Eastern Virginia Medical School recruited from May 1 to September 30, 2018', 'Two participants were first-year; 37, second-year; 12, third-year; and 10, fourth-year students']","['explicit conceptual instruction regarding diagnostic testing and bayesian revision (concept group), (2) exposure to repeated examples of cases with feedback regarding posttest probability (experience group), or (3) a control condition with no conceptual instruction or repeated examples', 'Teaching Bayesian Methods Using Learning by Concept vs Learning by Example']","['Mean (SE) probability estimates', 'probability of a diagnosis based on either negative or positive test results', 'calculated bayesian probability']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0036378', 'cui_str': 'Schools, Medical'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0242198', 'cui_str': 'Bayesian Method'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",61.0,0.049877,"Mean (SE) probability estimates of students in the concept group were statistically significantly closer to calculated bayesian probability than the other 2 groups (concept, 0.4%; [0.7%]; experience, 3.5% [0.7%]; control, 4.3% [0.7%]; P < .001).","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Brush', 'Affiliation': 'Cardiology Division, Department of Internal Medicine, Eastern Virginia Medical School, Sentara Healthcare, Norfolk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'McMaster Education Research, Innovation and Theory Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sherbino', 'Affiliation': 'McMaster Education Research, Innovation and Theory Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Taylor-Fishwick', 'Affiliation': 'Cardiology Division, Department of Internal Medicine, Eastern Virginia Medical School, Sentara Healthcare, Norfolk.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Norman', 'Affiliation': 'McMaster Education Research, Innovation and Theory Program, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18023']
2185,32493179,Effects of Preferred and Nonpreferred Warm-Up Music on Exercise Performance.,"This study investigated the effects of preferred and non-preferred warm-up music listening conditions on subsequent exercise performance. A total of 12 physically active male and female participants engaged in a crossover, counterbalanced research design in which they completed exercise trials after 3 different warm-up experiences of (a) no music (NM), (b) preferred music (PREF), and (c) nonpreferred music (NON-PREF). Participants began warming up by rowing at 50% of of age-predicted heart rate maximum (HR max ) for 5 minutes while exposed to the three music conditions. Immediately following the warm-up and cessation of any music, participants completed a 2000-m rowing time trial as fast as possible. Relative power output, trial time, heart rate, rating of perceived exertion, and motivation were analyzed. Results indicated that, compared with NM, relative power output was significantly higher ( p = .018), trial time was significantly lower ( p = .044), and heart rate was significantly higher ( p = .032) during the PREF but not the NON-PREF condition. Rating of perceived exertion was not altered, regardless of music condition ( p > .05). Motivation to exercise was higher during the PREF condition versus the NM ( p = .001) and NON-PREF ( p < .001) conditions. Listening to preferred warm-up music improved subsequent exercise performance compared with no music, while nonpreferred music did not impart ergogenic benefit.",2020,Motivation to exercise was higher during the PREF condition versus the NM ( p = .001) and NON-PREF ( p < .001) conditions.,['12 physically active male and female participants'],"['Preferred and Nonpreferred Warm-Up Music', 'no music (NM), (b) preferred music (PREF), and (c) nonpreferred music (NON-PREF', 'preferred and non-preferred warm-up music listening conditions']","['Exercise Performance', 'heart rate maximum (HR max ', 'trial time', 'Motivation to exercise', 'subsequent exercise performance', 'relative power output', 'heart rate', 'Rating of perceived exertion', 'Relative power output, trial time, heart rate, rating of perceived exertion, and motivation']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",12.0,0.167338,Motivation to exercise was higher during the PREF condition versus the NM ( p = .001) and NON-PREF ( p < .001) conditions.,"[{'ForeName': 'Morgan C', 'Initials': 'MC', 'LastName': 'Karow', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Rogers', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Pederson', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Williams', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Mallory R', 'Initials': 'MR', 'LastName': 'Marshall', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Ballmann', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}]",Perceptual and motor skills,['10.1177/0031512520928244']
2186,32492981,Impact of CD56 Continuously Recognizable as Prognostic Value of Acute Promyelocytic Leukemia: Results of Multivariate Analyses in the Japan Adult Leukemia Study Group (JALSG)-APL204 Study and a Review of the Literature.,"BACKGROUND
After long-term analysis of the JALSG-APL204 study we recently reported that maintenance therapy with tamibarotene was more effective than all-trans retinoic acid (ATRA) by reducing relapse in APL patients. Here, the clinical significance of other important prognostic factors was evaluated with multivariate analyses.
PATIENTS AND METHODS
Newly diagnosed acute promyelocytic leukemia (APL) patients were registered with the study. Induction was composed of ATRA and chemotherapy. Patients who achieved molecular remission after consolidation were randomly assigned to maintenance with tamibarotene or ATRA.
RESULTS
Of the 344 eligible patients, 319 (93%) achieved complete remission (CR). After completing consolidation, 269 patients underwent maintenance random assignment-135 to ATRA, and 134 to tamibarotene. By multivariate analysis, overexpression of CD56 in blast was an independent unfavorable prognostic factor for relapse-free survival (RFS) ( p = 0.006) together with more than 10.0 × 10 9 /L WBC counts ( p = 0.001) and the ATRA arm in maintenance ( p = 0.028). Of all phenotypes, CD56 was related most clearly to an unfavorable prognosis. The CR rate, mortality rate during induction and overall survival of CD56 + APL were not significantly different compared with CD56 - APL. CD56 is continuously an independent unfavorable prognostic factor for RFS in APL patients treated with ATRA and chemotherapy followed by ATRA or tamibarotene maintenance therapy.",2020,"The CR rate, mortality rate during induction and overall survival of CD56 + APL were not significantly different compared with CD56 - APL.","['Acute Promyelocytic Leukemia', 'Patients who achieved molecular remission after consolidation', 'Newly diagnosed acute promyelocytic leukemia (APL) patients were registered with the study', 'Japan Adult Leukemia Study Group ', '269 patients underwent maintenance random assignment-135 to ATRA, and 134 to tamibarotene']","['tamibarotene or ATRA', 'CD56', 'tamibarotene']","['CR rate, mortality rate during induction and overall survival of CD56 + APL', 'relapse-free survival (RFS', 'WBC counts', 'complete remission (CR']","[{'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C1567753', 'cui_str': 'tamibarotene'}]","[{'cui': 'C1567753', 'cui_str': 'tamibarotene'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0108754', 'cui_str': 'Lymphocyte antigen CD56'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0108754', 'cui_str': 'Lymphocyte antigen CD56'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",344.0,0.133671,"The CR rate, mortality rate during induction and overall survival of CD56 + APL were not significantly different compared with CD56 - APL.","[{'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Takeshita', 'Affiliation': 'Transfusion and Cell Therapy, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, Higashiku 431-3192, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Asou', 'Affiliation': 'International Medical Center, Saitama Medical University, 1397-1, Yamane, Hidaka 350-1298, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Atsuta', 'Affiliation': 'The Japanese Data Center for Hematopoietic Cell Transplantation, 1-1-20 Taikou-minami, Higashiku, Nagoya 461-0047, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Furumaki', 'Affiliation': 'Transfusion and Cell Therapy, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, Higashiku 431-3192, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sakura', 'Affiliation': 'Hematology, Saiseikai Maebashi Hospital, 564-1, Kamishindenmachi, Maebashi 371-0821, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Ueda', 'Affiliation': 'Hematology/Oncology, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki 710-8602, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Sawa', 'Affiliation': 'Hematology and Oncology, Anjo Kosei Hospital, 28 Higashikurokute, Anjochou, Anjo 446-8602, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Dobashi', 'Affiliation': 'Clinical Oncology/Hematology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8, Nishisinbashi, Minatoku, Tokyo 105-8461, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Hematology and Rheumatology, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Ohsakasayama 589-8511, Japan.'}, {'ForeName': 'Rikio', 'Initials': 'R', 'LastName': 'Suzuki', 'Affiliation': 'Hematology and Oncology, Tokai University School of Medicine, 143 Shimokasuya, Isahara 259-1193, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': 'Hematology and Rheumatology, Nihon University School of Medicine, 30-1 Ohyaguchikamichou, Itabashiku, Tokyo 173-8610, Japan.'}, {'ForeName': 'Shigehisa', 'Initials': 'S', 'LastName': 'Tamaki', 'Affiliation': 'Hematology, Japanese Red Cross Ise Hospital, 1-471-2 Funae, Ise 516-8512, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Hagihara', 'Affiliation': 'Hematology and Clinical Immunology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawaku, Yokohama 236-0004, Japan.'}, {'ForeName': 'Katsumichi', 'Initials': 'K', 'LastName': 'Fujimaki', 'Affiliation': 'Hematology, Fujisawa City Hospital, 2-6-1 Fujisawa, Fujisawa 251-8550, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Minamiguchi', 'Affiliation': 'Hematology, Shiga University of Medical Science, Seta-Tsukinowa, Otsu 520-2192, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Hematology, Saiseikai Yokohama Nanbu Hospital, 3-2-10 Kounandai, Kounanku, Yokohama 234-0054, Japan.'}, {'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Yanada', 'Affiliation': 'Hematology and Cell Therapy, Aichi Cancer Center, 1-1 Kanokoden, Chikusaku, Nagoya 464-8681, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Maeda', 'Affiliation': 'Hematology, Oncology and Respiratory Medicine, Okayama University Medical School, 2-5-1 Shikatachou, Kitaku, Okayama 700-8558, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Usui', 'Affiliation': 'Clinical Oncology/Hematology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8, Nishisinbashi, Minatoku, Tokyo 105-8461, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'National Cancer Center Hospital, 5-1-1 Tsukiji, Chuouku, Tokyo 104-0045, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kiyoi', 'Affiliation': 'Hematology and Oncology, Nagoya University Graduate School of Medicine, 65 Tsurumaichou, Showaku, Nagoya 466-8550, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Ohtake', 'Affiliation': 'Kanazawa University, Kakumamachi, Kanazawa 920-1192, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Hematology and Rheumatology, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Ohsakasayama 589-8511, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Naoe', 'Affiliation': 'National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Nakaku, Nagoya 460-0001, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Hematology, Atomic Bomb Institute, Nagasaki University, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan.'}, {'ForeName': 'The Japan Adult Leukemia Study', 'Initials': 'TJALS', 'LastName': 'Group', 'Affiliation': 'JALSG office, 3-6-35 Nishiki, Nakaku, Nagoya 460-0003, Japan.'}]",Cancers,['10.3390/cancers12061444']
2187,32493206,"Efficacy, tolerability, and safety of erenumab for the preventive treatment of persistent post-traumatic headache attributed to mild traumatic brain injury: an open-label study.","BACKGROUND
Calcitonin gene-related peptide (CGRP) has recently been implicated in the pathogenesis of post-traumatic headache (PTH), which raises the prospect for therapeutic use of monoclonal antibodies targeting CGRP or its receptor. Therefore, we decided to assess the efficacy, tolerability, and safety of erenumab for prevention of persistent PTH attributed to mild traumatic brain injury.
METHODS
A single-center, non-randomized, single-arm, open-label study of erenumab for adults aged 18-65 years with persistent PTH. Patients were assigned to receive 140-mg erenumab monthly by two subcutaneous 1-mL injections, given every 4 weeks for 12 weeks. The primary outcome measure was the mean change in number of monthly headache days of moderate to severe intensity from baseline (4-week pretreatment period) to week 9 through 12. Tolerability and safety endpoints were adverse events (i.e. number and type).
RESULTS
Eighty-nine of 100 patients completed the open-label trial. At baseline, the mean monthly number of headache days of moderate to severe intensity was 15.7. By week 9 through 12, the number was reduced by 2.8 days. The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15). Of 100 patients who received at least one dose of erenumab, two patients discontinued the treatment regimen due to adverse events.
CONCLUSIONS
Among patients with persistent PTH, erenumab resulted in a lower frequency of moderate to severe headache days in this 12-week open-label trial. In addition, erenumab was well-tolerated as discontinuations due to adverse events were low. Placebo-controlled randomized clinical trials are needed to adequately evaluate the efficacy and safety of erenumab in patients with persistent PTH.
TRIAL REGISTRATION
ClinicalTrials.Gov, NCT03974360. Registered on April 17, 2019 - Retrospectively registered.",2020,The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15).,"['adults aged 18-65\u2009years with persistent PTH', 'Eighty-nine of 100 patients completed the open-label trial', 'persistent post-traumatic headache attributed to mild traumatic brain injury', 'patients with\xa0persistent PTH']","['Calcitonin gene-related peptide (CGRP', 'erenumab', 'Placebo']","['Efficacy, tolerability, and safety', 'efficacy, tolerability, and safety', 'Tolerability and safety endpoints were adverse events (i.e. number and type', 'mean change in number of monthly headache days of moderate to severe intensity', 'efficacy and safety', 'mean monthly number of headache days of moderate to severe intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032816', 'cui_str': 'Posttraumatic headache'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.205377,The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15).,"[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Haidar Muhsen', 'Initials': 'HM', 'LastName': 'Al-Khazali', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Anna Kristina', 'Initials': 'AK', 'LastName': 'Eigenbrodt', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Eigil Lindekilde', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Amalie Middelboe', 'Initials': 'AM', 'LastName': 'Andersen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Kevin John', 'Initials': 'KJ', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Karoline Bendix', 'Initials': 'KB', 'LastName': 'Bräuner', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mørch-Jessen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Basit', 'Initials': 'B', 'LastName': 'Chaudhry', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Antic', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Casper Emil', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Faisal Mohammad', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Henrik Winther', 'Initials': 'HW', 'LastName': 'Schytz', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark. henrik.winther.schytz.01@regionh.dk.'}]",The journal of headache and pain,['10.1186/s10194-020-01136-z']
2188,22640466,Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial.,"OBJECTIVE
This study was conducted to determine the costs and comparative cost-effectiveness of two methods of abdominal aortic aneurysm (AAA) repair in the Open Versus Endovascular Repair (OVER) Veterans Affairs (VA) Cooperative Study, a multicenter randomized trial of 881 patients.
METHODS
The primary outcomes of this analysis were mean total health care cost per life-year and per quality-adjusted life-year (QALY) from randomization to 2 years after. QALYs were calculated from EuroQol (EQ)-5D questionnaires collected at baseline and annually. Health care utilization data were obtained directly from patients and from national VA and Medicare data sources. VA costs were obtained from national VA sources using methods previously developed by the VA Health Economics Resource Center. Costs for non-VA care were determined from Medicare claims data or billing data from the patient's health care providers.
RESULTS
After 2 years of follow-up, mean life-years were 1.78 in the endovascular repair group and 1.74 in the open repair group (difference, 0.04; 95% confidence interval [CI], -0.03 to 0.09; P = .29). Mean QALYs were 1.462 in the endovascular group and 1.461 in the open group (difference adjusting for baseline EQ-5D score, 0.006; 95% CI, -0.038 to 0.052; P = .78). Mean graft costs were higher in the endovascular group ($14,052 vs $1363; P < .001), but length of stay was shorter (5.0 vs 10.5 days; P < .001), resulting in a lower mean cost of the hospital admission for the AAA procedure in the endovascular repair group of $37,068 vs $42,970 (difference, -$5901; 95% CI, -$12,135 to -$821; P = .04). After 2 years, total health care costs remained lower in the endovascular group, but the difference was no longer significant (-$5019; 95% CI, -$16,720 to $4928; P = .35). The probability of endovascular repair being less costly and more effective was 70.9% for life-years and 51.4% for QALYs.
CONCLUSIONS
In this multicenter randomized trial, endovascular AAA repair resulted in lower cost and better survival than open repair after the initial hospitalization for repair; but after 2 years, survival, quality of life, and costs were not significantly different between the two treatments.",2012,"Mean graft costs were higher in the endovascular group ($14,052 vs $1363; P < .001), but length of stay was shorter (5.0 vs 10.5 days; P < .001), resulting in a lower mean cost of the hospital admission for the AAA procedure in the endovascular repair group of $37,068 vs $42,970 (difference, -$5901; 95% CI, -$12,135 to -$821; P = .04).",['881 patients'],"['endovascular AAA repair', 'open versus endovascular repair of abdominal aortic aneurysm', 'abdominal aortic aneurysm (AAA) repair']","['Mean graft costs', 'lower cost and better survival', 'costs and comparative cost-effectiveness', 'mean cost of the hospital admission', 'length of stay', 'EuroQol (EQ)-5D questionnaires', 'mean total health care cost per life-year and per quality-adjusted life-year (QALY', 'Mean QALYs', 'mean life-years', 'Cost-effectiveness', 'total health care costs', 'survival, quality of life, and costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0918249', 'cui_str': 'Endovascular repair of abdominal aortic aneurysm (procedure)'}, {'cui': 'C0162871', 'cui_str': 'Aortic Aneurysm, Abdominal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0034380'}]",881.0,0.318641,"Mean graft costs were higher in the endovascular group ($14,052 vs $1363; P < .001), but length of stay was shorter (5.0 vs 10.5 days; P < .001), resulting in a lower mean cost of the hospital admission for the AAA procedure in the endovascular repair group of $37,068 vs $42,970 (difference, -$5901; 95% CI, -$12,135 to -$821; P = .04).","[{'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Stroupe', 'Affiliation': 'Veterans Affairs Medical Center in Hines, Minneapolis, MN 55417, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Lederle', 'Affiliation': ''}, {'ForeName': 'Jon S', 'Initials': 'JS', 'LastName': 'Matsumura', 'Affiliation': ''}, {'ForeName': 'Tassos C', 'Initials': 'TC', 'LastName': 'Kyriakides', 'Affiliation': ''}, {'ForeName': 'Yvonne C', 'Initials': 'YC', 'LastName': 'Jonk', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ge', 'Affiliation': ''}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Freischlag', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery,['10.1016/j.jvs.2012.01.086']
2189,21804790,"Evaluation of ""no touch"" extubation technique on airway-related complications during emergence from general anesthesia.","BACKGROUND AND OBJECTIVES
Awake ""no touch"" extubation requires performing extubations only when the patient spontaneously wakes up without any kind of stimulation during emergence from general anesthesia. The aim of this study was to evaluate absolutely awake extubation ""no touch"" technique in adult patients, scheduled for elective nasal and paranasal sinus surgeries under general anesthesia as regard to emergence airway complications.
METHODS
A total of 60 adult patients were randomly allocated into one of two equal groups according to the method of extubation: Group I: Standard fully awake, Group II: Absolutely ""no touch"" awake extubation (absolutely no stimulation no touch was allowed until patients were able to open their eyes). The incidence of laryngospasm and its grade according to a four-point scale was reported. Occurrence of airway events (excessive secretions, breath-holding, coughing, hoarseness, biting, as well as the number and severity of any desaturation episodes), oozing from the wound, and postoperative sore throat were also recorded. The heart rate (HR), systolic (SBP) and diastolic (DBP) blood pressure measured at the end of surgery served as baseline values, and subsequent measurements were taken within 30 minutes after the end of surgery.
RESULTS
There was absolutely no case of laryngeal spasm or episode of desaturation among patients who were extubated with the ""no touch"" technique. On the other hand, there were 3 cases of laryngeal spasm in standard fully awake group. Severity of coughing, excessive secretions and breath holding, hoarseness, biting, and occurrence of non-purposeful movements of the limbs were significantly less in the absolutely ""no touch"" technique awake technique. The changes in HR, SBP, and DBP during emergence extubation were significantly less in ""no touch"" technique technique group. However, oozing from the wound was significantly higher with standard fully awake extubation. However, there were no significant differences between the two groups regarding the incidence of postoperative sore throat (39 and 36%, respectively).
CONCLUSION
The results of the present study showed that awake ""no touch"" technique technique for tracheal extubation produces less airway-related complications, as well as minimal hemodynamic response during emergence from general anesthesia in nasal and paranasal surgeries. It could be a safe alternative for tracheal extubation in airway surgery.",2011,"There was absolutely no case of laryngeal spasm or episode of desaturation among patients who were extubated with the ""no touch"" technique.","['adult patients, scheduled for elective nasal and paranasal sinus surgeries under general anesthesia', '60 adult patients']","['Standard fully awake, Group II: Absolutely ""no touch"" awake extubation (absolutely no stimulation no touch', 'no touch"" extubation technique', 'awake extubation ""no touch"" technique']","['heart rate (HR), systolic (SBP) and diastolic (DBP) blood pressure', 'Occurrence of airway events (excessive secretions, breath-holding, coughing, hoarseness, biting, as well as the number and severity of any desaturation episodes), oozing from the wound, and postoperative sore throat', 'laryngeal spasm', 'laryngeal spasm or episode of desaturation', 'incidence of postoperative sore throat', 'Severity of coughing, excessive secretions and breath holding, hoarseness, biting, and occurrence of non-purposeful movements of the limbs', 'changes in HR, SBP, and DBP during emergence extubation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0030471', 'cui_str': 'Paranasal Sinuses'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0445093', 'cui_str': 'No stimulation (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1320715', 'cui_str': 'Airway event'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0235744', 'cui_str': 'Breath Holding'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]",60.0,0.0198371,"There was absolutely no case of laryngeal spasm or episode of desaturation among patients who were extubated with the ""no touch"" technique.","[{'ForeName': 'Saad A', 'Initials': 'SA', 'LastName': 'Sheta', 'Affiliation': 'Department of Oral Maxillofacial Surgery, Dental College, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ashraf A', 'Initials': 'AA', 'LastName': 'Abdelhalim', 'Affiliation': ''}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Nada', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82778']
2190,22609540,Tinnitus retraining therapy: mixing point and total masking are equally effective.,"OBJECTIVES
Habituation to tinnitus cannot occur with total masking, an argument made by proponents of ""tinnitus retraining therapy."" We also compared the effectiveness of retraining therapy with mixing-point masking, total masking, and with counseling alone.
DESIGN
Forty-eight tinnitus patients were randomly assigned to one of three groups: counseling, counseling plus bilateral noise generators set to completely mask the tinnitus, or counseling plus bilateral noise generators with a focus on the mixing point (partial masking just below total masking). A picture-based counseling protocol was used to assist in providing similar counseling among all three groups. The Tinnitus Handicap Questionnaire was administered before and after about 12 months of treatment.
RESULTS
After 12 months, in the counseling group, three of 18 patients benefited significantly, in the mixing-point group, six of 19 patients benefited, and in the total masking group, four of 11 patients benefited from the treatment. The average decrease in the questionnaire was 16.7% for the counseling group, 31.6% for the retraining group, and 36.4% for the total masking group. No significant average differences among groups were observed.
CONCLUSIONS
One premise of retraining therapy is incorrect; a focus on mixing-point masking is not required for habituation.",2012,"The average decrease in the questionnaire was 16.7% for the counseling group, 31.6% for the retraining group, and 36.4% for the total masking group.",['Forty-eight tinnitus patients'],"['Tinnitus retraining therapy', 'retraining therapy with mixing-point masking, total masking, and with counseling alone', 'counseling, counseling plus bilateral noise generators set to completely mask the tinnitus, or counseling plus bilateral noise generators with a focus on the mixing point (partial masking just below total masking']",['Tinnitus Handicap Questionnaire'],"[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",48.0,0.0230067,"The average decrease in the questionnaire was 16.7% for the counseling group, 31.6% for the retraining group, and 36.4% for the total masking group.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Tyler', 'Affiliation': 'Departments of Otolaryngology-Head and Neck Surgery, The University of Iowa, Iowa City, Iowa 52242, USA. rich-tyler@uiowa.edu'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Noble', 'Affiliation': ''}, {'ForeName': 'Claudia Barros', 'Initials': 'CB', 'LastName': 'Coelho', 'Affiliation': ''}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Ji', 'Affiliation': ''}]",Ear and hearing,['10.1097/AUD.0b013e31824f2a6e']
2191,31377776,Thromboembolic events around the time of cardioversion for atrial fibrillation in patients receiving antiplatelet treatment in the ACTIVE trials.,"AIMS
It is unknown whether cardioversion of atrial fibrillation causes thromboembolic events or is a risk marker. To assess causality, we examined the temporal pattern of thromboembolism in patients having cardioversion.
METHODS AND RESULTS
We studied patients randomized to aspirin or aspirin plus clopidogrel in the ACTIVE trials, comparing the thromboembolic rate in the peri-cardioversion period (30 days before until 30 days after) to the rate during follow-up, remote from cardioversion. Among 962 patients, the 30-day thromboembolic rate remote from cardioversion was 0.16%; while it was 0.73% in the peri-cardioversion period [hazard ratio (HR) 4.1, 95% confidence interval (CI) 2.1-7.9]. The 30-day thromboembolic rates in the periods immediately before and after cardioversion were 0.47% and 0.96%, respectively (HR 2.2, 95% CI 0.7-7.1). Heart failure (HF) hospitalization increased in the peri-cardioversion period (HR 11.5, 95% CI 6.8-19.4). Compared to baseline, the thromboembolic rate in the 30 days following cardioversion was increased both in patients who received oral anticoagulation or a transoesophageal echocardiogram prior to cardioversion (HR 7.9, 95% CI 2.8-22.4) and in those who did not (HR 4.8, 95% CI 1.6-14.9) (interaction P = 0.2); the risk was also increased with successful (HR 4.5; 95% CI 2.0-10.5) and unsuccessful (HR 10.2; 95% CI 2.3-44.9) cardioversion.
CONCLUSIONS
Thromboembolic risk increased in the 30 days before cardioversion and persisted until 30 days post-cardioversion, in a pattern similar to HF hospitalization. These data suggest that the increased thromboembolic risk around the time of cardioversion may not be entirely causal, but confounded by the overall clinical deterioration of patients requiring cardioversion.",2019,"Compared to baseline, the thromboembolic rate in the 30 days following cardioversion was increased both in patients who received oral anticoagulation or a transoesophageal echocardiogram prior to cardioversion (HR 7.9, 95% CI 2.8-22.4) and in those who did not (HR 4.8, 95% CI 1.6-14.9) (interaction P = 0.2); the risk was also increased with successful (HR 4.5; 95% CI 2.0-10.5) and unsuccessful (HR 10.2; 95% CI 2.3-44.9) cardioversion.
","['patients having cardioversion', 'patients receiving antiplatelet treatment in the ACTIVE trials']",['aspirin or aspirin plus clopidogrel'],"['Thromboembolic events', 'thromboembolic risk', 'Heart failure (HF) hospitalization', 'thromboembolic rate', '30-day thromboembolic rates', '30-day thromboembolic rate remote from cardioversion', 'Thromboembolic risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}]",962.0,0.0807114,"Compared to baseline, the thromboembolic rate in the 30 days following cardioversion was increased both in patients who received oral anticoagulation or a transoesophageal echocardiogram prior to cardioversion (HR 7.9, 95% CI 2.8-22.4) and in those who did not (HR 4.8, 95% CI 1.6-14.9) (interaction P = 0.2); the risk was also increased with successful (HR 4.5; 95% CI 2.0-10.5) and unsuccessful (HR 10.2; 95% CI 2.3-44.9) cardioversion.
","[{'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'McIntyre', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Masiero', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Benz', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Wong', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Beresh', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}]",European heart journal,['10.1093/eurheartj/ehz521']
2192,21957409,Intra and postoperative outcome of adding clonidine to bupivacaine in infraorbital nerve block for young children undergoing cleft lip surgery.,"UNLABELLED
AIMS AND CONTEXT: To evaluate the efficacy of adding clonidine to bupivacaine in bilateral infraorbital nerve block for hemodynamic changes, requirement of opioids, volatile agent, and muscle relaxants intraoperatively and relief of pain postoperatively
SETTING AND DESIGN
Prospective, randomized, double-blind study.
METHODS
Fifty pediatric patients aged less than 24 months undergoing elective cleft lip repair were randomly allocated to two groups of 25 each. After tracheal intubation, group A received bilateral infraorbital nerve block with 1 ml solution of clonidine (1 μg/kg) and bupivacaine 0.25%, and group B received 1 ml of 0.25% bupivacaine. Hemodynamic parameters, intraoperative requirement of volatile anesthetic agent, muscle relaxant, and analgesic were recorded. Pain was assessed postoperatively using the Face, Legs, Activity, Cry, Consolability scale till the first rescue drug was given.
STATISTICAL ANALYSIS
Two sample unpaired t-test and the correlation r test.
RESULTS
The duration of analgesia from the time of administration of block in group A was 667.72 ± 210.74 min compared to 558.48 ± 150.28 min in group B (P<0.05).
CONCLUSION
Addition of clonidine as an adjunct to local anesthetic significantly decreased the requirement of other anesthetic drugs and significantly prolonged the duration of postoperative analgesia without any adverse effects.",2011,"Pain was assessed postoperatively using the Face, Legs, Activity, Cry, Consolability scale till the first rescue drug was given.
","['Fifty pediatric patients aged less than 24 months undergoing elective cleft lip repair', 'young children undergoing cleft lip surgery']","['clonidine', 'bilateral infraorbital nerve block with 1 ml solution of clonidine', 'bupivacaine']","['Face, Legs, Activity, Cry, Consolability scale', 'Pain', 'duration of postoperative analgesia', 'Hemodynamic parameters, intraoperative requirement of volatile anesthetic agent, muscle relaxant, and analgesic', 'duration of analgesia']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0008924', 'cui_str': 'Harelip'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0394792', 'cui_str': 'Local anesthetic infraorbital nerve block (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",50.0,0.357913,"Pain was assessed postoperatively using the Face, Legs, Activity, Cry, Consolability scale till the first rescue drug was given.
","[{'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Jindal', 'Affiliation': 'Department of Anesthesia Pain Management & ICU, Himalayan Institute of Medical Sciences, Jolly Grant, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Gurjeet', 'Initials': 'G', 'LastName': 'Khurana', 'Affiliation': ''}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Dvivedi', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Sharma', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.84104']
2193,21804791,Ultrasound-guided continuous infraclavicular brachial plexus block using bupivacaine alone or combined with adenosine for pain control in upper limb surgery.,"INTRODUCTION
The infraclavicular brachial plexus block (ICB) is designed to deposit anesthetic high in the plexus, achieving anesthesia of the hand, forearm, elbow, and distal arm. Adenosine is a metabolic intermediate that is involved in nearly all aspects of cell function, including neurotransmission and signal transduction.This study was aimed to show whether addition of adenosine to bupivacaine in ultrasound-guided ICB had an analgesic effect.
METHODS
Sixty adult patients were divided into two equal groups, each group included 30 patients. Group I received infraclavicular bupivacaine 0.325% in a volume of 30 ml. Group II received 30 ml of 0.325% bupivacaine + 12 mg adenosine. The block was maintained with an infusion of 10 ml/h. The following parameters were assessed: Success rate, time of the sensory onset, motor block, visual analog scale (VAS), and amount of i.v. pethidine needed.
RESULTS
This study showed an analgesic effect of infraclavicular adenosine as evidenced by a statistically significant shorter mean time of onset of the sensory block (16 vs. 20 min, P < 0.05), lower mean VAS score over 48 h (1.7 vs. 2.7, P < 0.05), longer mean time of first parenteral analgesic requirement (299 vs. 255 min, P < 0.05), and lower mean total dose of pethidine needed over 48 h after surgery (25.5 vs. 56.6 mg, P <0.05). All patients got successful infraclavicular block and recovered uneventfully without any sensory or motor deficit.
CONCLUSION
Adenosine may provide valuable addition to the therapeutic options in anesthesia and pain management. Further research is required to figure out its exact role.",2011,"This study showed an analgesic effect of infraclavicular adenosine as evidenced by a statistically significant shorter mean time of onset of the sensory block (16 vs. 20 min, P < 0.05), lower mean VAS score over 48 h (1.7 vs. 2.7, P < 0.05), longer mean time of first parenteral analgesic requirement (299 vs. 255 min, P < 0.05), and lower mean total dose of pethidine needed over 48 h after surgery (25.5 vs. 56.6 mg, P <0.05).","['Sixty adult patients were divided into two equal groups, each group included 30 patients', 'pain control in upper limb surgery']","['bupivacaine alone or combined with adenosine', 'infraclavicular bupivacaine', 'pethidine', 'adenosine to bupivacaine', 'Adenosine', 'infraclavicular adenosine', 'bupivacaine + 12 mg adenosine']","['mean time of onset of the sensory block', 'longer mean time of first parenteral analgesic requirement', 'lower mean VAS score', 'Success rate, time of the sensory onset, motor block, visual analog scale (VAS), and amount of i.v']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449244', 'cui_str': 'Time of onset (observable entity)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.0293629,"This study showed an analgesic effect of infraclavicular adenosine as evidenced by a statistically significant shorter mean time of onset of the sensory block (16 vs. 20 min, P < 0.05), lower mean VAS score over 48 h (1.7 vs. 2.7, P < 0.05), longer mean time of first parenteral analgesic requirement (299 vs. 255 min, P < 0.05), and lower mean total dose of pethidine needed over 48 h after surgery (25.5 vs. 56.6 mg, P <0.05).","[{'ForeName': 'Khaled M', 'Initials': 'KM', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Minoufiya University, Shebin El-Kom, Minoufiya, Egypt.'}, {'ForeName': 'Amany S', 'Initials': 'AS', 'LastName': 'Ammar', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82779']
2194,21804792,Single-injection percutaneous peribulbar anesthesia with a short needle versus sub-Tenon's anesthesia for cataract extraction.,"PURPOSE
This study compared the efficacy of single-injection percutaneous peribulbar anesthesia (PBA) with a short needle with sub-Tenon's anesthesia (STA) to produce optimal operating conditions for cataract extraction in patients with complicated cataract.
METHODS
Two hundred patients with complicated cataract were enrolled in this prospective, double-blinded, randomized study. Adequate akinesia was a surgical requisite for all cases included in the study because of the expected difficult surgery. The patients were divided into two equal groups to receive either peribulbar anesthesia (PBA) with a 16-mm needle or sub-Tenon's anesthesia. Surgical akinesia (as a primary end point), analgesia, incidence of complications, as well as patient and surgeon satisfaction (as secondary end points) were assessed.
RESULTS
Both techniques provided similar analgesia during the operation and similar rates of incidence of chemosis with no serious complications; while the PBA group provided higher degree of akinesia 10 minutes after injection of the local anesthetic, a lower incidence of subconjunctival hemorrhage (SCH) and higher patient and surgeon satisfaction compared to the STA group.
CONCLUSION
We concluded that when globe akinesia is necessary during surgery, the single-injection technique for percutaneous peribulbar anesthesia with a short needle proved to be more suitable than the STA in providing akinesia for cataract surgery. Also, this PBA technique demonstrated a lower incidence of SCH and was preferred to STA by the patients and surgeon.",2011,"Both techniques provided similar analgesia during the operation and similar rates of incidence of chemosis with no serious complications; while the PBA group provided higher degree of akinesia 10 minutes after injection of the local anesthetic, a lower incidence of subconjunctival hemorrhage (SCH) and higher patient and surgeon satisfaction compared to the STA group.
","['patients with complicated cataract', 'Two hundred patients with complicated cataract']","['PBA', 'STA', ""single-injection percutaneous peribulbar anesthesia (PBA) with a short needle with sub-Tenon's anesthesia (STA"", ""Single-injection percutaneous peribulbar anesthesia with a short needle versus sub-Tenon's anesthesia"", ""peribulbar anesthesia (PBA) with a 16-mm needle or sub-Tenon's anesthesia""]","['analgesia, incidence of complications, as well as patient and surgeon satisfaction', 'Surgical akinesia', 'subconjunctival hemorrhage (SCH) and higher patient and surgeon satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152259', 'cui_str': 'Cataract secondary to ocular disease (disorder)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0085623', 'cui_str': 'Akinesia (finding)'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",200.0,0.0205677,"Both techniques provided similar analgesia during the operation and similar rates of incidence of chemosis with no serious complications; while the PBA group provided higher degree of akinesia 10 minutes after injection of the local anesthetic, a lower incidence of subconjunctival hemorrhage (SCH) and higher patient and surgeon satisfaction compared to the STA group.
","[{'ForeName': 'Ashraf M', 'Initials': 'AM', 'LastName': 'Ghali', 'Affiliation': 'Department of Anesthesiology, Magrabi Eye & Ear Hospital, Muscat, Oman.'}, {'ForeName': 'Abdulkader', 'Initials': 'A', 'LastName': 'Mahfouz', 'Affiliation': ''}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Hafez', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82780']
2195,21804793,Neuraxial opioids in geriatrics: A dose reduction study of local anesthetic with addition of sufentanil in lower limb surgery for elderly patients.,"BACKGROUND AND OBJECTIVES
Neuraxial anesthesia in the elderly is associated with exaggerated responses to conventional doses of local anesthetics, thereby increasing the incidence of hemodynamic complications. A double-blind prospective study was carried out in our institute with an aim to compare the hemodynamic stability and quality of the conventional dose of hyperbaric bupivacaine (LA) with low dose of LA and sufentanil in elderly patients scheduled for lower limb surgery, randomized to receive combined spinal epidural anesthesia.
METHODS
A total of 50 elderly patients of ASA grade I and II, divided randomly into groups I and II, of either sex undergoing lower limb surgery under combined spinal epidural anesthesia at our institute attached to a Government Medical College were enrolled for study. Group I received 2.5 ml of intrathecal hyperbaric bupivacaine (LA), while group II received 1.5 ml of intrathecal LA+0.1 ml sufentanil (5 μg). Both initial and postoperative subarachnoid block characteristics, hemodynamic and respiratory parameters, duration of analgesia, and side effects were observed and recorded. Statistical analysis was carried out using Chi-square and paired t test.
RESULTS
Demographic profile was comparable in both groups. Group I had a greater incidence of hypotension and, consequently, higher use of vasopressors (P<0.05). Onset of sensory analgesia, time to achieve peak sensory level, and recovery from motor blockade were significantly earlier in group II (P<0.05). Postoperative consumption of LA through epidural route was significantly higher in group I (P<0.05). The side effect profile was similar, except for a significantly higher incidence of shivering in group I (P<0.05).
CONCLUSIONS
The study established that the dose of a local anesthetic can be safely and significantly lowered by 40%, with addition of low-dose sufentanil, thereby avoiding the hemodynamic fluctuation and providing a stable perioperative and postoperative period in the geriatric population. In addition, duration of sensory analgesia is prolonged and postoperative requirement for the epidural top-up also decreases.",2011,"Group I had a greater incidence of hypotension and, consequently, higher use of vasopressors (P<0.05).","['50 elderly patients of ASA grade I and II', 'elderly patients scheduled for lower limb surgery', 'at our institute attached to a Government Medical College were enrolled for study', 'elderly patients', 'in geriatrics']","['intrathecal hyperbaric bupivacaine (LA', 'Neuraxial opioids', 'sex undergoing lower limb surgery under combined spinal epidural anesthesia', 'LA and sufentanil', 'sufentanil', 'combined spinal epidural anesthesia', 'hyperbaric bupivacaine (LA', 'intrathecal LA+0.1 ml sufentanil']","['hemodynamic stability and quality', 'Postoperative consumption of LA through epidural route', 'incidence of hypotension', 'hemodynamic and respiratory parameters, duration of analgesia, and side effects', 'incidence of shivering', 'Onset of sensory analgesia, time to achieve peak sensory level, and recovery from motor blockade']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0592511', 'cui_str': 'Epidural use'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",50.0,0.0945878,"Group I had a greater incidence of hypotension and, consequently, higher use of vasopressors (P<0.05).","[{'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, Government Medical College, Patiala, India.'}, {'ForeName': 'Sukhminder Jit Singh', 'Initials': 'SJ', 'LastName': 'Bajwa', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82781']
2196,21804795,Comparison of pre- vs. post-incisional caudal bupivacaine for postoperative analgesia in unilateral pediatric herniorrhaphy: A double-blind randomized clinical trial.,"INTRODUCTION
This study was designed to evaluate the pre- vs. post-incisional analgesic efficacy of bupivacaine administered caudally in children undergoing unilateral hernia repair.
METHODS
Fifty children aged 6 months to 6 years were included in the study. Children were divided blindly between the two groups to receive pre- vs. post-incisional caudal bupivacaine. The preincisional group received 1 ml/kg of 0.125% bupivacaine caudally after induction of anesthesia and the postincisional group received the same dose caudally at the end of surgery. Heart rate, SaO(2), end tidal CO(2), and noninvasive arterial blood pressure were recorded every 10 min. The duration of surgery, extubation time, and duration of recovery period were also recorded. The pain scores were measured with using an Oucher chart in the recovery room, 2, 4, 6, 12, and 24 h after surgery. Time to first analgesia, numbers of supplementary analgesics required by each child in a 24-h period and total analgesic consumptions were recorded. Any local and systemic complications were recorded. Quantitative data were compared using a two-tailed t-test. Sex distribution and frequency of acetaminophen consumption were measured using χ(2) test. P < 0.05 was considered statistically significant.
RESULTS
The Oucher pain scale at 4, 6, 12, and 24 h after surgery, the total analgesic consumption and the numbers of demand for supplemental acetaminophen were lower statistically in preincisional group (P < 0.05). Extubation time and duration were higher in preincisional group (P < 0.05). Mean changes of heart rates were statistically lower during the anesthesia period and recovery time in preincisional group (P < 0.05).
CONCLUSION
Preincisional caudal analgesia with a single injection of 0.125% bupivacaine is more effective than the postincisional one for postoperative pain relief and analgesic consumption in unilateral pediatric herniorrhaphy.",2011,Extubation time and duration were higher in preincisional group (P < 0.05).,"['children undergoing unilateral hernia repair', 'unilateral pediatric herniorrhaphy', 'Fifty children aged 6 months to 6 years were included in the study']","['preincisional group received 1 ml/kg of 0.125% bupivacaine', 'Preincisional caudal analgesia with a single injection of 0.125% bupivacaine', 'pre- vs. post-incisional caudal bupivacaine', 'bupivacaine']","['total analgesic consumption and the numbers of demand for supplemental acetaminophen', 'Extubation time and duration', 'Time to first analgesia, numbers of supplementary analgesics required by each child in a 24-h period and total analgesic consumptions', 'Heart rate, SaO(2), end tidal CO(2), and noninvasive arterial blood pressure', 'postoperative pain relief and analgesic consumption', 'pain scores', 'Oucher pain scale', 'recovery time', 'Mean changes of heart rates', 'Sex distribution and frequency of acetaminophen consumption', 'duration of surgery, extubation time, and duration of recovery period']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036878', 'cui_str': 'Sex Distribution'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",50.0,0.301033,Extubation time and duration were higher in preincisional group (P < 0.05).,"[{'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Sajedi', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Yaraghi', 'Affiliation': ''}, {'ForeName': 'Mohammad Taher Dehdari', 'Initials': 'MT', 'LastName': 'Zadeh', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82783']
2197,22412776,Efficacy of tranexamic acid on blood loss during bimaxilary osteotomy: A randomized double blind clinical trial.,"BACKGROUND
Tranexamic acid has been used to reduce bleeding and the subsequent need for blood transfusion in many surgeries. Because orthognathic surgery can be associated with significant bleeding, this study evaluated the efficacy of prophylactic intravenous (IV) tranexamic acid on blood loss during bimaxillary osteotomy.
METHODS
Thirty-two consecutive patients, scheduled for elective bimaxillary osteotomy, were included in the study and 16 were randomly assigned to each group. They received tranexamic acid (20 mg/kg) or equal volume of placebo (normal saline) intravenously just before induction of anesthesia. Intraoperative blood loss, pre and post operative hemoglobin (Hb) and hematocrit (Hct) concentration, duration of surgery, hospital stay time, and rate of blood transfusion were recorded for each patient.
RESULTS
Intraoperative blood loss in the tranexamic group and control group were 585.9 and 790 mL respectively (P=0.008). Postoperative Hb concentration at the 6(th) hour was greater in the tranexamic group (P=0.008). There was no significant difference in the Hct concentration between the study groups. There was no significant difference in blood transfusion rate, hospital stay time and duration of surgery between the study groups.
CONCLUSION
Preoperative IV administration of tranexamic acid reduces the amount of blood loss during bimaxillary osteotomy.",2012,Postoperative Hb concentration at the 6(th) hour was greater in the tranexamic group (P=0.008).,"['bimaxillary osteotomy', 'Thirty-two consecutive patients, scheduled for elective bimaxillary osteotomy, were included in the study and 16 were randomly assigned to each group', 'bimaxilary osteotomy']","['placebo (normal saline', 'prophylactic intravenous (IV) tranexamic acid', 'tranexamic acid', 'tranexamic', 'Tranexamic acid']","['Postoperative Hb concentration', 'Hct concentration', 'blood loss', 'Intraoperative blood loss, pre and post operative hemoglobin (Hb) and hematocrit (Hct) concentration, duration of surgery, hospital stay time, and rate of blood transfusion', 'Intraoperative blood loss', 'blood transfusion rate, hospital stay time and duration of surgery']","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",32.0,0.291462,Postoperative Hb concentration at the 6(th) hour was greater in the tranexamic group (P=0.008).,"[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Karimi', 'Affiliation': 'Department of Craniomaxillofacial Surgery, Tehran University of Medical Sciences, Dr. Shariati Hospital, Tehran, Iran.'}, {'ForeName': 'Sussan Soltani', 'Initials': 'SS', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Hasheminasab', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.93057']
2198,22412779,Assessment of the hemodynamic changes following fluid preloading in cardiac surgery.,"BACKGROUND
This prospective double-blind randomized study aims to study the hemodynamic changes following fluid preloading with Hydroxyethyl starch (HES) 6% (130/0.4) compared with normal saline (NS) in cardiac surgery patients.
METHODS
Forty patients undergoing coronary artery bypass grafting (CABG) were enrolled in this study, then they were divided in 2 equal groups, HES and NS. After fast administration of 10 mL/kg from either solutions over 5 min only, hemodynamic parameters, such as heart rate, mean arterial pressure (MAP), central venous pressure (CVP), pulmonary artery occlusion pressure (PAOP), mean pulmonary artery pressure, systemic vascular resistance, and pulmonary vascular resistance were measured every 5 min for the total duration of 40 minutes.
RESULTS
There were significant differences in the cardiac index measurements between both groups at 15 min onward; also PAOP was significantly higher in HES group at 10 min onward. CVP was higher in HES group but statistically significant at 10 min only. MAP was higher in HES group, but that was statistically significant at 40 min only. On the other hand PAP was significantly higher at 10 and 40 min.
CONCLUSION
Fluid preloading with HES led to a significant increase in filling pressure of the left ventricle (PAOP) and cardiac index compared with NS. We believe that HES (130/0.4) could be a suitable solution for fluid preloading in CABG surgery patients. However, further studies are needed on different fluid preloading modalities with different dosing regimens.",2012,There were significant differences in the cardiac index measurements between both groups at 15 min onward; also PAOP was significantly higher in HES group at 10 min onward.,"['cardiac surgery patients', 'cardiac surgery', 'Forty patients undergoing', 'CABG surgery patients']","['HES', 'normal saline (NS', 'coronary artery bypass grafting (CABG', 'Hydroxyethyl starch (HES']","['filling pressure of the left ventricle (PAOP) and cardiac index', 'MAP', 'PAOP', 'CVP', 'cardiac index measurements', 'heart rate, mean arterial pressure (MAP), central venous pressure (CVP), pulmonary artery occlusion pressure (PAOP), mean pulmonary artery pressure, systemic vascular resistance, and pulmonary vascular resistance']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0018827', 'cui_str': 'Heart Ventricle'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary Artery Wedge Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}]",40.0,0.252129,There were significant differences in the cardiac index measurements between both groups at 15 min onward; also PAOP was significantly higher in HES group at 10 min onward.,"[{'ForeName': 'Raed A', 'Initials': 'RA', 'LastName': 'Alsatli', 'Affiliation': 'Department of Anesthesiologist, College of Medicine, King Fahad Cardiac Center, King Saud University, Riyadh, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.93064']
2199,22144926,Preanesthetic medication in children: A comparison of intranasal dexmedetomidine versus oral midazolam.,"BACKGROUND
Relieving preoperative anxiety is an important concern for the pediatric anesthesiologist. Midazolam has become the most frequently used premedication in children. However, new drugs such as the α(2) -agonists have emerged as alternatives for premedication in pediatric anesthesia.
METHODS
One hundred and twenty children scheduled for adenotonsillectomy were enrolled in this prospective, double-blind, randomized study. The children were divided into two equal groups to receive either intranasal dexmedetomidine 1 μg/kg (group D), or oral midazolam 0.5 mg/kg (group M) at approximately 60 and 30 mins, respectively, before induction of anesthesia. Preoperative sedative effects, anxiety level changes, and the ease of child-parent separation were assessed. Also, the recovery profile and postoperative analgesic properties were assessed.
RESULTS
Children premedicated with intranasal dexmedetomidine achieved significantly lower sedation levels (P=0.042), lower anxiety levels (P=0.036), and easier child-parent separation (P=0.029) than children who received oral midazolam at the time of transferring the patients to the operating room. Postoperatively, the time to achieve an Aldrete score of 10 was similar in both the groups (P=0.067). Also, the number of children who required fentanyl as rescue analgesia medication was significantly less (P=0.027) in the dexmedetomidine group.
CONCLUSION
Intranasal dexmedetomidine appears to be a better choice for preanesthetic medication than oral midazolam in our study. Dexmedetomidine was associated with lower sedation levels, lower anxiety levels, and easier child-parent separation at the time of transferring patients to the operating room than children who received oral midazolam. Moreover, intranasal dexmedetomidine has better analgesic property than oral midazolam with discharge time from postanesthetic care unit similar to oral midazolam.",2011,"Also, the number of children who required fentanyl as rescue analgesia medication was significantly less (P=0.027) in the dexmedetomidine group.
","['One hundred and twenty children scheduled for adenotonsillectomy', 'children']","['oral midazolam', 'Midazolam', 'Dexmedetomidine', 'midazolam', 'intranasal dexmedetomidine', 'Preanesthetic medication', 'dexmedetomidine']","['lower anxiety levels', 'rescue analgesia medication', 'lower sedation levels, lower anxiety levels, and easier child-parent separation', 'recovery profile and postoperative analgesic properties', 'sedation levels', 'time to achieve an Aldrete score', 'Preoperative sedative effects, anxiety level changes, and the ease of child-parent separation']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0032924', 'cui_str': 'Preanesthetic Medication'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C3179159', 'cui_str': 'Sedative Effect'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",120.0,0.0482823,"Also, the number of children who required fentanyl as rescue analgesia medication was significantly less (P=0.027) in the dexmedetomidine group.
","[{'ForeName': 'Ashraf M', 'Initials': 'AM', 'LastName': 'Ghali', 'Affiliation': 'Department of Anesthesia, Magrabi Eye & Ear Hospital, Muscat, Sultanate of Oman.'}, {'ForeName': 'Abdul Kader', 'Initials': 'AK', 'LastName': 'Mahfouz', 'Affiliation': ''}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Al-Bahrani', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.87268']
2200,21957405,"Comparison of streamlined liner of the pharynx airway (SLIPA™) with the laryngeal mask airway Proseal™ for lower abdominal laparoscopic surgeries in paralyzed, anesthetized patients.","CONTEXT
Supraglottic airway devices have been used as an alternative to tracheal intubation during laparoscopic surgery.
AIMS
The study was designed to compare the efficacy of Streamlined Liner of the Pharynx Airway (SLIPA) for positive pressure ventilation and postoperative complications with the Laryngeal Mask Airway ProSeal (PLMA) for patients undergoing lower abdominal laparoscopies under general anesthesia with controlled ventilation.
SETTINGS AND DESIGN
Prospective, crossover randomized controlled trial performed on patients undergoing lower abdominal laparoscopic surgeries.
METHODS
A total of 120 patients undergoing lower abdominal laparoscopic surgeries were randomly allocated into two equal groups; PLMA and SLIPA groups. Number of intubation attempts, insertion time, ease of insertion, and fiberoptic bronchoscopic view were recorded. Lung mechanics data were collected 5 minutes after securing the airway, then after abdominal insufflation. Blood traces and regurgitation were checked for; postoperative sore throat and other complications were recorded.
STATISTICAL ANALYSIS
Arithmetic mean and standard deviation values were calculated and statistical analyses were performed for each group. Independent sample t-test was used to compare continuous variables exhibiting normal distribution, and Chi-squared test for noncontinuous variables. P value <0.05 was considered significant.
RESULTS
Insertion time, first insertion success rate, and ease of insertion were comparable in both groups. Fiberoptic bronchoscopic view was significantly better and epiglottic downfolding was significantly lower in SLIPA group. Sealing pressure and lung mechanics were similar. Gastric distension was not observed in both groups. Postoperative sore throat was significantly higher in PACU in PLMA group. Blood traces on the device were significantly more in SLIPA group.
CONCLUSIONS
SLIPA can be used as a useful alternative to PLMA in patients undergoing lower abdominal laparoscopic surgery with muscle relaxant and controlled ventilation.",2011,Fiberoptic bronchoscopic view was significantly better and epiglottic downfolding was significantly lower in SLIPA group.,"['paralyzed, anesthetized patients', 'patients undergoing lower abdominal laparoscopic surgery with muscle relaxant and controlled ventilation', '120 patients undergoing lower abdominal laparoscopic surgeries', 'patients undergoing lower abdominal laparoscopies under general anesthesia with controlled ventilation', 'patients undergoing lower abdominal laparoscopic surgeries']","['Laryngeal Mask Airway ProSeal (PLMA', 'Streamlined Liner of the Pharynx Airway (SLIPA', 'PLMA and SLIPA', 'streamlined liner of the pharynx airway (SLIPA™) with the laryngeal mask airway Proseal™']","['Blood traces and regurgitation', 'Insertion time, first insertion success rate, and ease of insertion', 'Number of intubation attempts, insertion time, ease of insertion, and fiberoptic bronchoscopic view', 'Sealing pressure and lung mechanics', 'Blood traces', 'Gastric distension', 'Postoperative sore throat', 'postoperative sore throat and other complications', 'Arithmetic mean and standard deviation values']","[{'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0181663', 'cui_str': 'Liner (physical object)'}, {'cui': 'C0031354', 'cui_str': 'Throat'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]","[{'cui': 'C0005768'}, {'cui': 'C0442822', 'cui_str': 'Trace (qualifier value)'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439630', 'cui_str': 'First insertion (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",120.0,0.0702113,Fiberoptic bronchoscopic view was significantly better and epiglottic downfolding was significantly lower in SLIPA group.,"[{'ForeName': 'Ashraf Abualhassan', 'Initials': 'AA', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Menoufiya University, Egypt.'}, {'ForeName': 'Monaz Abdulrahman', 'Initials': 'MA', 'LastName': 'Ali', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.84100']
2201,21957406,Epidural anesthesia and post-operative analgesia for bilateral inguinal mesh hernioplasty: Comparison of equipotent doses of ropivacaine and bupivacaine.,"OBJECTIVES
Ropivacaine is a long-acting amide local anesthetic, which is structurally very similar to bupivacaine but produces less motor block and less cardiac and central nervous system toxicity. It is also about 40% less potent than bupivacaine. Our double blind study was designed to compare the clinical efficacy of the equipotent doses of ropivacaine 0.75% and bupivacaine 0.5% for epidural anesthesia and ropivacaine 0.2% and bupivacaine 0.125% for post-operative analgesia in patients undergoing bilateral mesh hernioplasty.
METHODS
Sixty-one patients were randomized to receive 15 ml of 0.75% ropivacaine or 0.5% bupivacaine. Sensory and motor block characteristics were compared. Changes in heart rate, mean arterial blood pressure, and adverse effects were noted. For post-operative analgesia, 0.2% ropivacaine and 0.125% bupivacaine were given as continuous epidural infusion. Analgesia using VAS scores, motor block, volume of local anesthetic used and patient satisfaction was assessed.
RESULTS
There was no significant variation in the sensory block profile. A greater intensity of motor block was achieved with bupivacaine in the beginning but by 30 minutes the difference was not significant. Duration of motor block was similar in the two groups. Visual analog scale scores were similar in both groups during the post-operative period, with a similar motor block profile. No major side effects were noted in any group.
CONCLUSION
The equipotent doses of ropivacaine and bupivacaine provided good quality epidural anesthesia and post-operative analgesia.",2011,A greater intensity of motor block was achieved with bupivacaine in the beginning but by 30 minutes the difference was not significant.,"['Sixty-one patients', 'patients undergoing bilateral mesh hernioplasty', 'bilateral inguinal mesh hernioplasty']","['ropivacaine and bupivacaine', 'ropivacaine or 0.5% bupivacaine', 'bupivacaine', 'Epidural anesthesia and post-operative analgesia', 'ropivacaine', 'Ropivacaine']","['sensory block profile', 'intensity of motor block', 'major side effects', 'heart rate, mean arterial blood pressure, and adverse effects', 'Analgesia using VAS scores, motor block, volume of local anesthetic used and patient satisfaction', 'clinical efficacy', 'Duration of motor block', 'good quality epidural anesthesia and post-operative analgesia', 'Visual analog scale scores']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0018246', 'cui_str': 'Groin'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",61.0,0.167906,A greater intensity of motor block was achieved with bupivacaine in the beginning but by 30 minutes the difference was not significant.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Korula', 'Affiliation': 'Department of Anaesthesiology, MOSC Medical College, Kolenchery, Kerala, India.'}, {'ForeName': 'Grace Maria', 'Initials': 'GM', 'LastName': 'George', 'Affiliation': ''}, {'ForeName': 'Shaloo', 'Initials': 'S', 'LastName': 'Ipe', 'Affiliation': ''}, {'ForeName': 'Saramma P', 'Initials': 'SP', 'LastName': 'Abraham', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.84101']
2202,21957407,A single-centre randomized-controlled trial to study effect of dilution on propofol-induced injection pain at injection site.,"BACKGROUND
Propofol is a commonly used short-acting intravenous anaesthetic agent. A major disadvantage of propofol is pain at injection site with high incidence up to 90%. Various modalities have been tried to obtund propofol-induced pain; however, search for an ideal agent continues. We assessed the effect of double and triple dilution of 1% propofol emulsion with normal saline on pain at injection site.
METHODS
This randomized, double-blinded study was done on 60 adult patients of both sexes, belonging to ASA grade I and II scheduled for elective surgery under general anesthesia, divided into three groups named I, II, III of 20 patients each. The patients of group I, II, and III received 1% propofol 2 ml, 0.5% propofol 4 ml, and 0.33% propofol 6 ml, respectively, over a period of 4 s and pain felt was assessed.
RESULTS
There was no statistically significant difference in the pain score in group II as compared to patients in group I. However, there was a statistically significant decrease in the pain score in group III as compared to patients in group I (P value 0.02) and group II (P value 0.03).
CONCLUSIONS
We found a significant decrease in both incidence and severity of pain during injection with a 0.33% propofol solution without significant adverse hemodynamic effects. The small size of data was a limitation in our study and a large-scale study will be needed to prove its therapeutic beneficence.",2011,We found a significant decrease in both incidence and severity of pain during injection with a 0.33% propofol solution without significant adverse hemodynamic effects.,"['I and II scheduled for elective surgery under general anesthesia', '60 adult patients of both sexes, belonging to ASA grade']","['Propofol', 'propofol emulsion with normal saline', 'propofol', 'propofol-induced injection pain at injection site', 'propofol 2 ml, 0.5% propofol 4 ml, and 0.33% propofol']","['pain score', 'pain at injection site', 'adverse hemodynamic effects', 'incidence and severity of pain']","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517449', 'cui_str': 'Zero point three three'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.114338,We found a significant decrease in both incidence and severity of pain during injection with a 0.33% propofol solution without significant adverse hemodynamic effects.,"[{'ForeName': 'Sourabh', 'Initials': 'S', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Anaesthesiology & Critical Care, University College of Medical Sciences, Guru Teg Bahadur Hospital, Shahdara, India.'}, {'ForeName': 'Mahendra', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.84102']
2203,21957401,The evaluation of upper leg traction in lateral position for pediatric caudal block.,"PURPOSE
A well-functioning caudal block is an excellent adjunct to general anesthesia, but misplaced injection results in poor analgesia as well as possibility of serious morbidity. Therefore, the purpose of this study was to evaluate the effectiveness of leg traction on success rate of caudal block in lateral position in children.
METHODS
Two hundred children, age 2 months to 6 years, ASA I and II, who underwent lower abdominal surgeries were randomized in prospective controlled clinical trial study in two groups. After induction of General anesthesia, the caudal block was performed in the lateral position with upper leg traction (L-T-) or with the standard position (S-P) (leg flexed 90°). Hemodynamicchanges, movement of lower extremity in response to surgical stimulus were evaluated.
RESULTS
There was no significant difference in caudal block's success rate between two groups at first attempt (P=0.25). In group (S-P) the procedure was successful in 60% of cases at first attempt, 25% at second,10% at third attempt and 5% failure of caudal block, whereas in the first group it was 75%, 20%, 1% and 4% of cases respectively. There were no significant differences in heart rate and blood pressure changes between two groups (P>0.05).
CONCLUSION
The success rate of pediatric caudal block in upper leg traction did not differ from that of the standard position.",2011,There was no significant difference in caudal block's success rate between two groups at first attempt (P=0.25).,"['Two hundred children, age 2 months to 6 years, ASA I and II, who underwent lower abdominal surgeries', 'children']",['leg traction'],"[""caudal block's success rate"", 'heart rate and blood pressure changes', 'success rate of pediatric caudal block']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]",200.0,0.0226618,There was no significant difference in caudal block's success rate between two groups at first attempt (P=0.25).,"[{'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Seyedhejazi', 'Affiliation': 'Department of Anesthesiology, Tabriz Children Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Taheri', 'Affiliation': ''}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Ghojazadeh', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.84096']
2204,21957410,"A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging.","AIM
To compare the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging procedures.
METHODS
Sixty children between the age of 1 to 7 years were randomly distributed into two groups: The dexmedetomidine (D) group received 1 μg/kg initial dose followed by continuous infusion of 0.5 μg/kg/h, and the propofol group (P) received 3 mg/kg initial dose, followed by a continuous infusion of 100 μg/kg/min. Inadequate sedation was defined as difficulty in completing the procedure because of the child's movement during magnetic resonance imaging. Mean arterial pressure (MAP), heart rate, peripheral oxygen saturation, and respiratory rate (RR) were recorded during the study.
RESULT
The onset of sedation, recovery, and discharge time were significantly shorter in group P than in group D. MAP, heart rate, and RR decreased during sedation from the baseline values in both groups. MAP and RR were significantly lower in group P than in group D during sedation. Dexmedetomidine and propofol provided adequate sedation in most of the children.
CONCLUSION
We conclude that although propofol provided faster anesthetic induction and recovery times, it caused hypotension and desaturation. Dexmedetomidine could be an alternative, reliable sedative drug to propofol in selected patients.",2011,"The onset of sedation, recovery, and discharge time were significantly shorter in group P than in group D. MAP, heart rate, and RR decreased during sedation from the baseline values in both groups.","['selected patients', 'children undergoing magnetic resonance imaging', 'Sixty children between the age of 1 to 7 years', 'children undergoing magnetic resonance imaging procedures']","['Dexmedetomidine', 'propofol', 'Dexmedetomidine and propofol', 'dexmedetomidine and propofol', 'dexmedetomidine (D) group received 1 μg/kg initial dose followed by continuous infusion of 0.5 μg/kg/h, and the propofol']","['Mean arterial pressure (MAP), heart rate, peripheral oxygen saturation, and respiratory rate (RR', 'anesthetic induction and recovery times', 'MAP and RR', 'heart rate, and RR', 'Inadequate sedation', 'onset of sedation, recovery, and discharge time', 'hypotension and desaturation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",60.0,0.0811951,"The onset of sedation, recovery, and discharge time were significantly shorter in group P than in group D. MAP, heart rate, and RR decreased during sedation from the baseline values in both groups.","[{'ForeName': 'Jaydev', 'Initials': 'J', 'LastName': 'Dave', 'Affiliation': 'Department of Anaesthesiology, M. P. Shah Medical College, Jamnagar, Gujarat, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Vaghela', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.84105']
2205,21902964,A simple vacuum dressing reduces the wound infection rate of single-incision pediatric endosurgical appendectomy.,"BACKGROUND AND OBJECTIVES
After introducing single-incision pediatric endosurgical (SIPES) appendectomy at our institution, we noticed an increased number of post-operative umbilical infections. This study evaluates the impact of a simple, low-cost wound vacuum dressing on the wound infection rate.
METHODS
Umbilical wounds after single-incision laparoscopic appendectomy were covered with standard dressing (approximating strips), or the new umbilical vacuum dressing. A wound infection was defined as an infected umbilicus requiring antibiotics, or incision and drainage. The wound infection rate was compared between both groups. Statistical analysis was performed using Fischer's exact test. Continuous variables were compared using the Student t test.
RESULTS
Included in this study were 183 children, 97 of whom were treated with the vacuum dressing. The study populations were no different in terms of age, weight, operative time, blood loss, length of stay, or proportion of acute versus perforated appendicitis. A total of 7 (3.8%) wound infections occurred, 1 in the vacuum dressing group (1%), versus 6 in the conventional dressing group (7%, P=0.038).
CONCLUSIONS
This simple, low-cost umbilical vacuum dressing decreased the wound infection rate after SIPES appendectomy, possibly by absorbing secretions from the base of the wound. It may be equally effective for other indications.",2011,"The study populations were no different in terms of age, weight, operative time, blood loss, length of stay, or proportion of acute versus perforated appendicitis.","['Umbilical wounds after single', 'single-incision pediatric endosurgical appendectomy', '183 children, 97 of whom were treated with the vacuum dressing']","['incision laparoscopic appendectomy', 'simple, low-cost wound vacuum dressing', 'vacuum dressing', 'standard dressing (approximating strips), or the new umbilical vacuum dressing']","['wound infections', 'wound infection rate', 'age, weight, operative time, blood loss, length of stay, or proportion of acute versus perforated appendicitis']","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]","[{'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0854119', 'cui_str': 'Perforated Appendicitis'}]",183.0,0.0537774,"The study populations were no different in terms of age, weight, operative time, blood loss, length of stay, or proportion of acute versus perforated appendicitis.","[{'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Muensterer', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA. oliver.muensterer@att.net'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keijzer', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680811X13071180406592']
2206,21804796,Comparative study of dopamine and norepinephrine in the management of septic shock.,"OBJECTIVE
The objective was to compare the ability of norepinephrine and dopamine in reversing the hemodynamic and metabolic abnormalities of septic shock using Edwards Vigileo Monitor with Flotrac Sensor.
DESIGN
Prospective randomized control study.
METHODS
Fifty consecutive patients presenting with hyperdynamic septic shock who fulfilled the inclusion criteria were randomly allocated to either group I or group II. The goal of therapy was to achieve and maintain for 6 hours, all of the following - systolic blood pressure (SBP) >90 mmHg, systemic vascular resistance index (SVRI) >1800 dynes.s/cm(5)m(2), cardiac index (CI) >4.0 lt/min/m(2), index of oxygen delivery >550 ml/min/m(2), index of oxygen uptake >150 ml/min/m(2). The patients in group I were started on dopamine infusion at 10 μg/kg/min which was increased by 2.5 μg/kg/min, every 15 minutes till the goals were achieved. The patients in group II received norepinephrine infusion started at a dose of 0.5 μg/kg/min with a dose increment of 0.25 μg/kg/min, every 15 minutes till the goals were achieved.
RESULTS
Post-treatment heart rate showed an increase in the mean value in group I patients and a decrease in group II patients. The post-treatment mean SBP and SVRI in group II was significantly higher than that in group I. Patients in group I showed a significantly higher increase in post-treatment CI and index of oxygen delivery compared to patients in group II. Nineteen out of 25 patients responded to the treatment in group II while only 10 out of 25 responded in group I.
CONCLUSION
Norepinephrine was more useful in reversing the hemodynamic and metabolic abnormalities of hyperdynamic septic shock compared to dopamine.",2011,"Nineteen out of 25 patients responded to the treatment in group II while only 10 out of 25 responded in group I.
CONCLUSION
Norepinephrine was more useful in reversing the hemodynamic and metabolic abnormalities of hyperdynamic septic shock compared to dopamine.","['Fifty consecutive patients presenting with hyperdynamic septic shock who fulfilled the inclusion criteria', 'septic shock']","['norepinephrine infusion', 'Norepinephrine', 'dopamine infusion', 'dopamine and norepinephrine', 'norepinephrine and dopamine']","['post-treatment CI and index of oxygen delivery', 'hemodynamic and metabolic abnormalities of hyperdynamic septic shock', 'systolic blood pressure (SBP) >90 mmHg, systemic vascular resistance index (SVRI) >1800 dynes.s/cm(5)m(2), cardiac index (CI) >4.0 lt/min/m(2), index of oxygen delivery >550 ml/min/m(2), index of oxygen uptake', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0349413', 'cui_str': 'Hyperdynamic septic shock (disorder)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}]","[{'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0349413', 'cui_str': 'Hyperdynamic septic shock (disorder)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index (observable entity)'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",50.0,0.0429666,"Nineteen out of 25 patients responded to the treatment in group II while only 10 out of 25 responded in group I.
CONCLUSION
Norepinephrine was more useful in reversing the hemodynamic and metabolic abnormalities of hyperdynamic septic shock compared to dopamine.","[{'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Department of Internal Medicine, Chattrapati Shahuji Maharaj Medical University, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Shuchi', 'Initials': 'S', 'LastName': 'Consul', 'Affiliation': ''}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Shastri', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82784']
2207,21804799,Comparison of two ventilation modes in post-cardiac surgical patients.,"BACKGROUND
The cardiopulmonary bypass (CPB)-associated atelectasis accounted for most of the marked post-CPB increase in shunt and hypoxemia. We hypothesized that pressure-regulated volume-control (PRVC) modes having a distinct theoretical advantage over pressure-controlled ventilation (PCV) by providing the target tidal volume at the minimum available pressure may prove advantageous while ventilating these atelactic lungs.
METHODS
In this prospective study, 36 post-cardiac surgical patients with a PaO(2)/FiO(2) (arterial oxygen tension/Fractional inspired oxygen) < 300 after arrival to intensive care unit (ICU), (n = 34) were randomized to receive either PRVC or PCV. Air way pressure (P(aw)) and arterial blood gases (ABG) were measured at four time points [T1: After induction of anesthesia, T2: after CPB (in the ICU), T3: 1 h after intervention mode, T4: 1 h after T3]. Oxygenation index (OI) = [PaO(2)/ {FiO(2) × mean airway pressure (P(mean))}] was calculated for each set of data and used as an indirect estimation for intrapulmonary shunt.
RESULTS
There is a steady and significant improvement in OI in both the groups at first hour [PCV, 27.5(3.6) to 43.0(7.5); PRVC, 26.7(2.8) to 47.6(8.2) (P = 0.001)] and second hour [PCV, 53.8(6.4); PRVC, 65.8(7.4) (P = 0.001)] of ventilation. However, the improvement in OI was more marked in PRVC at second hour of ventilation owing to significant low mean air way pressure compared to the PCV group [PCV, 8.6(0.8); PRVC, 7.7(0.5), P = 0.001].
CONCLUSIONS
PRVC may be useful in a certain group of patients to reduce intrapulmonary shunt and improve oxygenation after cardiopulmonary bypass-induced perfusion mismatch.",2011,"There is a steady and significant improvement in OI in both the groups at first hour [PCV, 27.5(3.6) to 43.0(7.5); PRVC, 26.7(2.8) to 47.6(8.2) (P = 0.001)] and second hour [PCV, 53.8(6.4); PRVC, 65.8(7.4) (P = 0.001)] of ventilation.","['36 post-cardiac surgical patients with a PaO(2)/FiO(2) (arterial oxygen tension/Fractional inspired oxygen', ' 300 after arrival to intensive care unit (ICU), (n = 34', 'post-cardiac surgical patients']","['pressure-regulated volume-control (PRVC) modes having a distinct theoretical advantage over pressure-controlled ventilation (PCV', 'PRVC or PCV']","['Oxygenation index (OI) ', '× mean airway pressure (P(mean', 'PRVC', 'Air way pressure (P(aw)) and arterial blood gases (ABG', 'PaO(2)/ {FiO(2']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial (procedure)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449972', 'cui_str': 'Volume control (attribute)'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation (procedure)'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}]","[{'cui': 'C1278185', 'cui_str': 'Oxygenation index'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}]",34.0,0.0226178,"There is a steady and significant improvement in OI in both the groups at first hour [PCV, 27.5(3.6) to 43.0(7.5); PRVC, 26.7(2.8) to 47.6(8.2) (P = 0.001)] and second hour [PCV, 53.8(6.4); PRVC, 65.8(7.4) (P = 0.001)] of ventilation.","[{'ForeName': 'Aloka', 'Initials': 'A', 'LastName': 'Samantaray', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, India.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hemanth', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82790']
2208,21804800,Oral premedication with pregabalin or clonidine for hemodynamic stability during laryngoscopy and laparoscopic cholecystectomy: A comparative evaluation.,"BACKGROUND
Hemodynamic responses of laryngoscopy and laparoscopy should be attenuated by the appropriate premedication, smooth induction, and rapid intubation. The present study evaluated the clinical efficacy of oral premedication with pregabalin or clonidine for hemodynamic stability during laryngoscopy and laparoscopic cholecystectomy.
METHODS
A total of 180 healthy adult consented patients aged 35 to 52 years with American Society of Anesthesiologist (ASA) physical status I and II of both gender, who met the inclusion criteria for elective laparoscopic cholecystectomy, were randomized to receive placebo Group I, pregabalin (150 mg) Group II, or clonidine (200 μg) Group III, given 75 to 90 minutes before surgery as oral premedication. All groups were compared for preoperative sedation and anxiety level along with changes of heart rate and mean arterial pressure prior to premedication, before induction, after laryngoscopy, pneumoperitoneum, release of carbon dioxide, and extubation. Intraoperative analgesic drug requirement and any postoperative complications were also recorded.
RESULTS
Pregabalin and clonidine proved to have sedative and anxiolytic effects as oral premedicants and decreased the need of intraoperative analgesic drug requirement. Clonidine was superior to pregabalin for attenuation of the hemodynamic responses to laryngoscopy and laparoscopy, but it increased the incidence of intra-and postoperative bradycardia. No significant differences in the parameters of recovery were observed between the groups. None of the premedicated patient has suffered from any postoperative side effects.
CONCLUSION
Oral premedication with pregabalin 150 mg or clonidine 200 μg causes sedation and anxiolysis with hemodynamic stability during laryngoscopy and laparoscopic cholecystectomy, without prolongation of recovery time and side effects.",2011,"Clonidine was superior to pregabalin for attenuation of the hemodynamic responses to laryngoscopy and laparoscopy, but it increased the incidence of intra-and postoperative bradycardia.","['180 healthy adult consented patients aged 35 to 52 years with American Society of Anesthesiologist (ASA) physical status I and II of both gender, who met the inclusion criteria for elective laparoscopic cholecystectomy']","['laryngoscopy and laparoscopy', 'laryngoscopy and laparoscopic cholecystectomy', 'placebo', 'pregabalin', 'pregabalin or clonidine', 'clonidine', 'Clonidine']","['recovery time and side effects', 'hemodynamic stability', 'preoperative sedation and anxiety level', 'sedative and anxiolytic effects', 'heart rate and mean arterial pressure prior to premedication, before induction, after laryngoscopy, pneumoperitoneum, release of carbon dioxide, and extubation', 'incidence of intra-and postoperative bradycardia', 'Intraoperative analgesic drug requirement and any postoperative complications', 'parameters of recovery']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C3179404', 'cui_str': 'Antianxiety Effects'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",180.0,0.0251229,"Clonidine was superior to pregabalin for attenuation of the hemodynamic responses to laryngoscopy and laparoscopy, but it increased the incidence of intra-and postoperative bradycardia.","[{'ForeName': 'Kumkum', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology & Crtical Care, N.S.C.B. Subharti Medical College, Subhartipuram, NH-58, Meerut, Uttarpradesh, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Prashant K', 'Initials': 'PK', 'LastName': 'Gupta', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82791']
2209,21804801,"Is sealing cuff pressure, easy, reliable and safe technique for endotracheal tube cuff inflation?: A comparative study.","OBJECTIVE
To compare the three common methods of endotracheal tube cuff inflation (sealing pressure, precise standard pressure or finger estimation) regarding the effective tracheal seal and the incidence of post-intubation airway complications.
METHODS
Seventy-five adult patients scheduled for N(2) O free general anesthesia were enrolled in this study. After induction of anesthesia, endotracheal tubes size 7.5 mm for female and 8.0 mm for male were used. Patients were randomly assigned into one of three groups. Control group (n=25), the cuff was inflated to a pressure of 25 cm H(2)O; sealing group (n=25), the cuff was inflated to prevent air leaks at airway pressure of 20 cm H(2)O and finger group (n=25), the cuff was inflated using finger estimation. Tracheal leaks, incidence of sore throat, hoarseness and dysphagia were tested.
RESULTS
Although cuff pressure was significantly low in the sealing group compared to the control group (P<0.001), the incidence of sore throat was similar in both groups. On the other hand, cuff pressure as well as the incidence of sore throat were significantly higher in the finger group compared to both the control and the sealing group (P<0.001 and P=0.008). The incidence of dysphagia and hoarseness were similar in the three groups. None of the patients in the three groups developed air leak around the endotracheal tube cuff..
CONCLUSIONS
In N(2)O, free anesthesia sealing cuff pressure is an easy, undemanding and safe alternative to the standard technique, regarding effective sealing and low incidence of sore throat.",2011,"Although cuff pressure was significantly low in the sealing group compared to the control group (P<0.001), the incidence of sore throat was similar in both groups.","['Seventy-five adult patients scheduled for N(2', 'O free general anesthesia']","['endotracheal tube cuff inflation (sealing pressure, precise standard pressure or finger estimation', 'cuff was inflated to prevent air leaks at airway pressure of 20 cm H(2)O and finger group']","['incidence of dysphagia and hoarseness', 'cuff pressure', 'incidence of sore throat', 'Tracheal leaks, incidence of sore throat, hoarseness and dysphagia', 'air leak']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff, device (physical object)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]",75.0,0.0271133,"Although cuff pressure was significantly low in the sealing group compared to the control group (P<0.001), the incidence of sore throat was similar in both groups.","[{'ForeName': 'Roshdi R', 'Initials': 'RR', 'LastName': 'Al-Metwalli', 'Affiliation': 'Department of Anesthesia, University of Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abdulmohsen A', 'Initials': 'AA', 'LastName': 'Al-Ghamdi', 'Affiliation': ''}, {'ForeName': 'Hany A', 'Initials': 'HA', 'LastName': 'Mowafi', 'Affiliation': ''}, {'ForeName': 'Sayed', 'Initials': 'S', 'LastName': 'Sadek', 'Affiliation': ''}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Abdulshafi', 'Affiliation': ''}, {'ForeName': 'Wesam F', 'Initials': 'WF', 'LastName': 'Mousa', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82795']
2210,31145798,Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial.,"AIMS
The antiplatelet treatment strategy providing optimal balance between thrombotic and bleeding risks in patients undergoing coronary artery bypass grafting (CABG) is unclear. We prospectively compared the efficacy of ticagrelor and aspirin after CABG.
METHODS AND RESULTS
We randomly assigned in double-blind fashion patients scheduled for CABG to either ticagrelor 90 mg twice daily or 100 mg aspirin (1:1) once daily. The primary outcome was the composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG. The main safety endpoint was based on the Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings. The study was prematurely halted after recruitment of 1859 out of 3850 planned patients. Twelve months after CABG, the primary endpoint occurred in 86 out of 931 patients (9.7%) in the ticagrelor group and in 73 out of 928 patients (8.2%) in the aspirin group [hazard ratio 1.19; 95% confidence interval (CI) 0.87-1.62; P = 0.28]. All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group. The main safety endpoint was also not significantly different (ticagrelor 3.7% vs. aspirin 3.2%, hazard ratio 1.17, CI 0.71-1.92; P = 0.53).
CONCLUSION
In this prematurely terminated and thus underpowered randomized trial of ticagrelor vs. aspirin in patients after CABG no significant differences in major cardiovascular events or major bleeding could be demonstrated.
CLINICALTRIALS.GOV IDENTIFIER
NCT01755520.",2019,"All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group.","['patients undergoing coronary artery bypass grafting (CABG', 'patients after coronary artery bypass grafting', '3850 planned patients']","['aspirin', 'ticagrelor', 'CABG to either ticagrelor 90\u2009mg twice daily or 100\u2009mg aspirin', 'ticagrelor and aspirin', 'ticagrelor vs. aspirin']","['composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG', 'Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings', 'cardiovascular death', 'major cardiovascular events or major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",3850.0,0.279313,"All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group.","[{'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Boening', 'Affiliation': 'Department of Cardiovascular Surgery, Justus-Liebig University Gießen, Ludwigstraße 23, Gießen, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'von Scheidt', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Lanig', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Gusmini', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'de Waha', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Kuna', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fach', 'Affiliation': 'Department of Cardiology and Angiology, Klinikum Links der Weser, Senator-Weßling-Straße 1, Bremen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Grothusen', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Arnold-Heller-Straße 3, Kiel, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Oberhoffer', 'Affiliation': 'Department of Cardiac Surgery, Asklepios Klinik St. Georg, Lohmühlenstraße 5, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Knosalla', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Augustenburger Platz 1, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walther', 'Affiliation': 'Department of Cardiac Surgery, Kerckhoff Heart and Thorax Center, Benekestraße 2-8, Bad Nauheim, Germany.'}, {'ForeName': 'Bernhard C', 'Initials': 'BC', 'LastName': 'Danner', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Medical Center, Robert-Koch-Straße 40, Göttingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Misfeld', 'Affiliation': 'University Department of Cardiac Surgery, Leipzig Heart Center, Strümpellstraße 39, Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen and Institut für Herzinfarktforschung Ludwigshafen, Bremserstraße 79, Ludwigshafen, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Wimmer-Greinecker', 'Affiliation': 'Department for Cardiothoracic Surgery, Heart and Vessel Center Bad Bevensen, Römstedter Straße 25, Bad Bevensen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Siepe', 'Affiliation': 'Department of Cardiovascular Surgery, Heart Centre Freiburg University, University of Freiburg, Hugstetter Straße 55, Freiburg, Germany.'}, {'ForeName': 'Herko', 'Initials': 'H', 'LastName': 'Grubitzsch', 'Affiliation': 'Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, Charitéplatz 1, Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Joost', 'Affiliation': 'Department of Cardiology, Angiology and Intensive Care Medicine, Medical Clinic II, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, Lübeck, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schaefer', 'Affiliation': 'Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Lenard', 'Initials': 'L', 'LastName': 'Conradi', 'Affiliation': 'Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Cremer', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Arnold-Heller-Straße 3, Kiel, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Justus-Liebig University Gießen, Kerckhoff Campus, Ludwigstraße 23, Gießen, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Lange', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Radke', 'Affiliation': 'Department of Internal Medicine-Cardiology, Schön Klinik Neustadt SE & Co. KG, Am Kiebitzberg 10, Neustadt, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Schulz', 'Affiliation': 'Institute of Physiology, Justus-Liebig University Gießen, Aulweg 129, Gießen, Germany.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Laufer', 'Affiliation': 'Division of Cardiac Surgery, Medical University Vienna, Spitalgasse 23, Wien, Austria.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grieshaber', 'Affiliation': 'Department of Cardiovascular Surgery, Justus-Liebig University Gießen, Ludwigstraße 23, Gießen, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Pader', 'Affiliation': 'Department of Cardiology and Angiology, Klinikum Links der Weser, Senator-Weßling-Straße 1, Bremen, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Attmann', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Arnold-Heller-Straße 3, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schmoeckel', 'Affiliation': 'Department of Cardiac Surgery, Asklepios Klinik St. Georg, Lohmühlenstraße 5, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Augustenburger Platz 1, Berlin, Germany.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Ziegelhöffer', 'Affiliation': 'Department of Cardiac Surgery, Kerckhoff Heart and Thorax Center, Benekestraße 2-8, Bad Nauheim, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hambrecht', 'Affiliation': 'Department of Cardiology and Angiology, Klinikum Links der Weser, Senator-Weßling-Straße 1, Bremen, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Sigrid E', 'Initials': 'SE', 'LastName': 'Sandner', 'Affiliation': 'Division of Cardiac Surgery, Medical University Vienna, Spitalgasse 23, Wien, Austria.'}]",European heart journal,['10.1093/eurheartj/ehz185']
2211,31155673,Impact of preoperative fractional flow reserve on arterial bypass graft anastomotic function: the IMPAG trial.,"AIMS
Visual estimation is the most commonly used method to evaluate the degree of coronary artery stenosis prior to coronary artery bypass grafting. In interventional cardiology, the use of fractional flow reserve (FFR) to guide revascularization decisions has become routine. We investigated whether the preoperative FFR measurement of coronary lesions is associated with anastomosis function 6 months after surgical revascularization using a multiarterial grafting strategy.
METHODS AND RESULTS
In this prospective double-blind study, 67 patients were enrolled from two institutions in Europe and Canada. From these patients, 199 coronary lesions were assessed visually and with FFR at the time of the preoperative angiogram. All patients received coronary revascularization using multiple arterial grafts. A post-operative 6-month angiogram was performed to assess anastomosis functionality using a described angiographic method. The primary outcome was the association between preoperative FFR values and anastomosis function 6 months after surgery. Preoperative FFR was significantly associated with 6-months anastomotic function for all conduits and for all targets (P < 0.001). An FFR value of ≤0.78 was associated with an anastomotic occlusion rate of 3%.
CONCLUSION
We found a significant association between the preoperative FFR measurement of the target vessel and the anastomotic functionality at 6 months, with a cut-off of 0.78. Integration of FFR measurement into the preoperative diagnostic workup before multiarterial coronary surgical revascularization leads to improved anastomotic graft function.
CLINICAL TRIALS. GOV IDENTIFIER
NCT02527044.",2019,Preoperative FFR was significantly associated with 6-months anastomotic function for all conduits and for all targets (P < 0.001).,['67 patients were enrolled from two institutions in Europe and Canada'],['coronary revascularization using multiple arterial grafts'],"['arterial bypass graft anastomotic function', 'anastomotic occlusion rate', '6-months anastomotic function', 'Preoperative FFR', 'preoperative FFR values and anastomosis function', 'preoperative FFR measurement of the target vessel and the anastomotic functionality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0450140', 'cui_str': 'Arterial graft (morphologic abnormality)'}]","[{'cui': 'C0189695', 'cui_str': 'Arterial bypass graft'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}]",67.0,0.0303736,Preoperative FFR was significantly associated with 6-months anastomotic function for all conduits and for all targets (P < 0.001).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Glineur', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Juan B', 'Initials': 'JB', 'LastName': 'Grau', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Etienne', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'Department of Cardiothoracic Surgery, New York Presbyterian-Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jacqueline H', 'Initials': 'JH', 'LastName': 'Fortier', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Spiridon', 'Initials': 'S', 'LastName': 'Papadatos', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Laruelle', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pieters', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'El Khoury', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Blouard', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Timmermans', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Aun-Yeong', 'Initials': 'AY', 'LastName': 'Chong', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'So', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Rubens', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Mario Fl', 'Initials': 'MF', 'LastName': 'Gaudino', 'Affiliation': 'Department of Cardiothoracic Surgery, New York Presbyterian-Weill Cornell Medicine, New York, NY, USA.'}]",European heart journal,['10.1093/eurheartj/ehz329']
2212,22412770,Comparison of propofol versus sevoflurane on thermoregulation in patients undergoing transsphenoidal pituitary surgery: A preliminary study.,"PURPOSE
General anesthesia causes inhibition of thermoregulatory mechanisms. Propofol has been reported to cause more temperature fall, but in case of deliberate mild hypothermia, both sevoflurane and propofol were comparable. Thermoregulation is found to be disturbed in cases of pituitary tumors. We aimed to investigate which of the two agents, sevoflurane or propofol, results in better preservation of thermoregulation in patients undergoing transsphenoidal excision of pituitary tumors.
METHODS
Twenty-six patients scheduled to undergo transsphenoidal removal of pituitary adenomas were randomly allocated to receive propofol or sevoflurane anesthesia. Baseline esophageal temperature was noted. Times for temperature to fall by 1°C or 35°C and to return to baseline were also comparable (P>0.05). After that warmer was started at 43°C and time to rise to baseline was noted. Duration of surgery, total blood loss, and total fluid intake were also noted. If any, side effects such as delayed arousal and recovery from muscle relaxant were noted.
RESULTS
The demographics of the patients were comparable. Duration of surgery and total blood loss were comparable in the two groups. The time for temperature to fall by 1°C or 35°C and time to return to baseline was also comparable (P>0.05). No side effects related to body temperature were noted.
CONCLUSION
Both propofol and sevoflurane show similar effects in maintaining thermal homeostasis in patients undergoing transsphenoidal pituitary surgery.",2012,The time for temperature to fall by 1°C or 35°C and time to return to baseline was also comparable (P>0.05).,"['patients undergoing transsphenoidal excision of pituitary tumors', 'Twenty-six patients scheduled to undergo transsphenoidal removal of pituitary adenomas', 'patients undergoing transsphenoidal pituitary surgery']","['propofol or sevoflurane anesthesia', 'Propofol', 'propofol and sevoflurane', 'propofol', 'sevoflurane', 'sevoflurane or propofol']","['Baseline esophageal temperature', 'thermal homeostasis', 'Duration of surgery and total blood loss', 'Duration of surgery, total blood loss, and total fluid intake']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205508', 'cui_str': 'Transsphenoidal approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0032019', 'cui_str': 'Pituitary Tumors'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0032000', 'cui_str': 'Pituitary Adenoma'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake (observable entity)'}]",26.0,0.0322224,The time for temperature to fall by 1°C or 35°C and time to return to baseline was also comparable (P>0.05).,"[{'ForeName': 'Tumul', 'Initials': 'T', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Neuroanesthesiology, Neurosciences Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Hemanshu', 'Initials': 'H', 'LastName': 'Prabhakar', 'Affiliation': ''}, {'ForeName': 'Sachidanand Jee', 'Initials': 'SJ', 'LastName': 'Bharati', 'Affiliation': ''}, {'ForeName': 'Keshav', 'Initials': 'K', 'LastName': 'Goyal', 'Affiliation': ''}, {'ForeName': 'Surya Kumar', 'Initials': 'SK', 'LastName': 'Dube', 'Affiliation': ''}, {'ForeName': 'Gyaninder Pal', 'Initials': 'GP', 'LastName': 'Singh', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.93046']
2213,22412771,The outcome of thoracic epidural anesthesia in elderly patients undergoing coronary artery bypass graft surgery.,"BACKGROUND
Thoracic epidural anesthesia (TEA) improves analgesia and outcomes after a cardiac surgery. As aging is a risk factor for postoperative pulmonary complications, TEA is of particular importance in elderly patients undergoing coronary artery bypass graft (CABG).
METHODS
Fifty patients aged 65-75 years; ASA II and III scheduled for elective CABG were included in the study. Patients were randomized to receive either general anesthesia (GA) group alone or GA combined with TEA group. Heart rate (HR), mean arterial pressure (MAP), and central venous pressure were recorded. Total dose of fentanyl μg/kg, aortic cross clamping, cardiopulmonary bypass (CPB) time, time to first awaking and extubation, arterial blood gases, visual analog scale (VAS) score in intensive care unit were reported. Postoperative pulmonary function tests were done.
RESULTS
TEA showed a significant HR and lower MAP compared with the GA group. The total dose of intraoperative fentanyl and nitroglycerine were significantly lower in the TEA. Patients in TEA group have statistically significantly higher PaO(2), lower PaCO(2), increase in Forced Vital Capacity (FVC) and Forced Expiratory Volume in one second (FEV(1))
CONCLUSIONS
TEA reduced severity of postoperative pulmonary function and restoration was faster in TEA group in elderly patients undergoing CABG. Also, it resulted in earlier extubation and awakening, better analgesia, lower VAS.",2012,"Patients in TEA group have statistically significantly higher PaO(2), lower PaCO(2), increase in Forced Vital Capacity (FVC) and Forced Expiratory Volume in one second (FEV(1))
","['Fifty patients aged 65-75 years; ASA II and III scheduled for elective CABG were included in the study', 'elderly patients undergoing CABG', 'elderly patients undergoing coronary artery bypass graft (CABG', 'elderly patients undergoing coronary artery bypass graft surgery']","['TEA', 'Thoracic epidural anesthesia (TEA', 'general anesthesia (GA) group alone or GA combined with TEA', 'thoracic epidural anesthesia', 'fentanyl μg/kg, aortic cross clamping, cardiopulmonary bypass']","['higher PaO(2), lower PaCO(2', 'Forced Vital Capacity (FVC) and Forced Expiratory Volume in one second (FEV(1', 'Heart rate (HR), mean arterial pressure (MAP), and central venous pressure', 'CPB) time, time to first awaking and extubation, arterial blood gases, visual analog scale (VAS) score', 'earlier extubation and awakening, better analgesia, lower VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",50.0,0.135044,"Patients in TEA group have statistically significantly higher PaO(2), lower PaCO(2), increase in Forced Vital Capacity (FVC) and Forced Expiratory Volume in one second (FEV(1))
","[{'ForeName': 'Gamal Z', 'Initials': 'GZ', 'LastName': 'El-Morsy', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'El-Deeb', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.93048']
2214,22412772,The efficacy of 0.75% levobupivacaine versus 0.75% ropivacaine for peribulbar anesthesia in vitreoretinal surgery.,"BACKGROUND
We evaluated the anesthetic efficacy and the postoperative analgesic effects of 0.75% levobupivacaine versus 0.75% ropivacaine for peribulbar anesthesia in patients undergoing primary vitreoretinal surgery.
METHODS
We investigated 120 patients subjected to vitreoretinal surgery under peribulbar anesthesia. They were randomized into two equal groups according to the local anesthetic (LA) used, namely, 0.75% levobupivacaine or 0.75% ropivacaine, both with the addition of hyaluronidase. Nerve block was carried out by injection of 5-7 mL of the LA using single injection percutaneous peribulbar anesthesia with a short needle.
RESULTS
When compared with 0.75% ropivacaine, 0.75% levobupivacaine provided more successful akinesia at 10 min after block (P=0.026), fewer supplementary injections (P=0.026), and less volume (mL) was used (P=0.031). Also, levobupivacaine provided significantly longer motor block duration (342±27 min versus 206±40 min, P=0.001) and significantly longer sensory block duration (513±24 min versus 394±11 min, P=0.001) when compared with ropivacaine. In the postoperative period, the patients in the levobupivacaine group achieved lower values of verbal numeric rating scale of pain compared with patients in the ropivacaine group among the period from 4 to 12 h. Also, there were significantly (P=0.001) lower diclofenac consumption (mg) and the percentage of patients who required tramadol rescue medication were significantly less (P=0.034) in the levobupivacaine group compared with the ropivacaine group.
CONCLUSION
We are concluding that, at equipotent doses and concentrations, 0.75% levobupivacaine provides more effective peribulbar anesthesia and more effective postoperative analgesia for vitreoretinal surgery compared with 0.75% ropivacaine.",2012,"In the postoperative period, the patients in the levobupivacaine group achieved lower values of verbal numeric rating scale of pain compared with patients in the ropivacaine group among the period from 4 to 12 h.","['peribulbar anesthesia in vitreoretinal surgery', 'patients undergoing primary vitreoretinal surgery', '120 patients subjected to vitreoretinal surgery under peribulbar anesthesia']","['ropivacaine', 'levobupivacaine', 'levobupivacaine or 0.75% ropivacaine', 'local anesthetic (LA']","['successful akinesia', 'longer motor block duration', 'sensory block duration', 'tramadol rescue medication', 'verbal numeric rating scale of pain']","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0085623', 'cui_str': 'Akinesia (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.0340575,"In the postoperative period, the patients in the levobupivacaine group achieved lower values of verbal numeric rating scale of pain compared with patients in the ropivacaine group among the period from 4 to 12 h.","[{'ForeName': 'Ashraf M', 'Initials': 'AM', 'LastName': 'Ghali', 'Affiliation': 'Department of Aanaesthesia, Magrabi Eye and Ear Hospital, Muscat, Sultanate of Oman.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.93050']
2215,22412775,Epidural analgesia during labor vs no analgesia: A comparative study.,"BACKGROUND
Epidural analgesia is claimed to result in prolonged labor. Previous studies have assessed epidural analgesia vs systemic opioids rather than to parturients receiving no analgesia. This study aimed to evaluate the effect of epidural analgesia on labor duration compared with parturients devoid of analgesia.
METHODS
One hundred sixty nulliparous women in spontaneous labor at full term with a singleton vertex presentation were assigned to the study. Parturients who request epidural analgesia were allocated in the epidural group, whereas those not enthusiastic to labor analgesia were allocated in the control group. Epidural analgesia was provided with 20 mL bolus 0.5% epidural lidocaine plus fentanyl and maintained at 10 mL for 1 h. Duration of the first and second stages of labor, number of parturients receiving oxytocin, maximal oxytocin dose required for each parturient, numbers of instrumental vaginal, vacuum-assisted, and cesarean deliveries and neonatal Apgar score were recorded.
RESULTS
There was no statistical difference in the duration of the active-first and the second stages of labor, instrumental delivery, vacuum-assisted or cesarean delivery rates, the number of newborns with 1-min and 5-min Apgar scores less than 7 between both groups and number of parturients receiving oxytocin, however, the maximal oxytocin dose was significantly higher in the epidural group.
CONCLUSION
Epidural analgesia by lidocaine (0.5%) and fentanyl does not prolong labor compared with parturients without analgesia; however, significant oxytocin augmentation is required during the epidural analgesia to keep up the aforementioned average labor duration.",2012,"There was no statistical difference in the duration of the active-first and the second stages of labor, instrumental delivery, vacuum-assisted or cesarean delivery rates, the number of newborns with 1-min and 5-min Apgar scores less than 7 between both groups and number of parturients receiving oxytocin, however, the maximal oxytocin dose was significantly higher in the epidural group.
","['Parturients who request epidural analgesia', 'parturients devoid of analgesia', 'One hundred sixty nulliparous women in spontaneous labor at full term with a singleton vertex presentation']","['lidocaine plus fentanyl', 'oxytocin', 'oxytocin, maximal oxytocin', 'Epidural analgesia during labor vs no analgesia', 'lidocaine', 'fentanyl', 'epidural analgesia', 'Epidural analgesia']","['cesarean deliveries and neonatal Apgar score', 'maximal oxytocin dose', 'labor duration', 'duration of the active-first and the second stages of labor, instrumental delivery, vacuum-assisted or cesarean delivery rates, the number of newborns with 1-min and 5-min Apgar scores']","[{'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0233260', 'cui_str': 'Vertex presentation (finding)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery (procedure)'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",160.0,0.0838315,"There was no statistical difference in the duration of the active-first and the second stages of labor, instrumental delivery, vacuum-assisted or cesarean delivery rates, the number of newborns with 1-min and 5-min Apgar scores less than 7 between both groups and number of parturients receiving oxytocin, however, the maximal oxytocin dose was significantly higher in the epidural group.
","[{'ForeName': 'Wesam Farid', 'Initials': 'WF', 'LastName': 'Mousa', 'Affiliation': 'Department of Anesthesia, Dammam University, Kingdom of Saudi Arabia.'}, {'ForeName': 'Roshdi', 'Initials': 'R', 'LastName': 'Al-Metwalli', 'Affiliation': ''}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.93055']
2216,30946523,"Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial.","OBJECTIVES
To report the long-term oncological outcomes of a randomised trial comparing androgen-deprivation therapy (ADT) combined with external beam radiation therapy (EBRT) and ADT alone in patients with locally advanced prostate cancer.
PATIENTS AND METHODS
In this multicentre phase III trial, patients were randomly assigned to ADT alone or ADT+EBRT. Leuprorelin 11.25 mg was administered for 3 years. The whole pelvis was treated at a dose of 46 Gy and the prostate with a boost from 20 to 28 Gy. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), disease-specific survival (DSS), locoregional PFS (LRPFS), metastasis-free survival (MFS), biochemical PFS (BPFS), and tolerance.
RESULTS
With a median follow-up of 7.3 years, 263 patients were included. The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% vs 7%; hazard ratio [HR] 0.27, 95% confidence interval [CI] 0.17-0.39; P < 0.001); in patients with a baseline PSA level ≥50 ng/mL (HR 0.10, 95% CI 0.05-0.20; P < 0.001) and in patients with a baseline PSA level <50 ng/mL (HR 0.28, 95% CI 0.19-0.40; P < 0.001). The risk of death from prostate cancer was significantly reduced in the ADT+EBRT arm (sub-HR [SHR] 0.48, 95% CI 0.25-0.91; P = 0.02). The 8-year OS rate was 57% in the ADT arm and 65% in the ADT+EBRT arm (no significant difference). LRPFS was significantly in favour of the ADT+EBRT arm (SHR 0.61, 95% CI 0.42-0.89; P = 0.01). MFS was comparable between both arms (P = 0.88). Analysis of toxicities revealed acute lower tolerance in the ADT+EBRT arm, with a gradual decrease in intensity from 6 months after the end of EBRT.
CONCLUSIONS
These long-term results confirm the oncological benefit of combining EBRT with ADT in the treatment of locally advanced prostate cancer.",2020,"The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% versus 7%; hazard ratio: 0.27; 95%CI: (0.17;0.39), p<0.0001) (hazard ratio [HR] = 0.10; 95%CI: (0.05; 0.20); p < 0.0001 in patients with baseline PSA ≥ 50ng/ml and HR = 0.28; 95%CI: (0.19; 0.40), p < 0.0001 in patients with baseline PSA < 50ng/ml).","['locally advanced prostate cancer', 'locally-advanced prostate cancer', 'With a median follow-up of 7.3 years, 263 patients were included', 'patients treated with locally advanced prostate cancer']","['Leuprorelin', 'Long-term androgen deprivation, with or without radiotherapy', 'ADT alone or ADT+EBRT', 'EBRT with ADT', 'androgen-deprivation therapy (ADT) combined with external beam radiation therapy (EBRT) and ADT alone']","['progression-free survival (PFS', 'overall survival (OS), disease-specific survival (DSS), locoregional progression free survival (LPFS), metastasis-free survival (MFS), biochemical progression free survival (BPFS) and tolerance', 'MFS', '8-year PFS rate', '8-year OS rate', 'risk of death from prostate cancer', 'LPFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",263.0,0.383482,"The 8-year PFS rate was significantly higher in the ADT+EBRT arm than in the ADT arm (48% versus 7%; hazard ratio: 0.27; 95%CI: (0.17;0.39), p<0.0001) (hazard ratio [HR] = 0.10; 95%CI: (0.05; 0.20); p < 0.0001 in patients with baseline PSA ≥ 50ng/ml and HR = 0.28; 95%CI: (0.19; 0.40), p < 0.0001 in patients with baseline PSA < 50ng/ml).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargos', 'Affiliation': 'Department of Radiation Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mottet', 'Affiliation': 'Department of Urology, University Hospital, Saint-Etienne, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Bellera', 'Affiliation': 'Clinical and Epidemiological Research Unit, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Richaud', 'Affiliation': 'Department of Radiation Oncology, Institut Bergonié, Bordeaux, France.'}]",BJU international,['10.1111/bju.14768']
2217,31539295,Negative Hyperselection of Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer Who Received Panitumumab-Based Maintenance Therapy.,"PURPOSE
We assessed the prognostic/predictive role of primary tumor sidedness and uncommon alterations of anti-epidermal growth factor receptor (EGFR) primary resistance (primary resistance in RAS and BRAF wild-type metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with RAS / BRAF wild-type (wt) metastatic colorectal cancer (mCRC) who were randomly assigned to panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino trial (ClinicalTrials.gov identifier: NCT02476045).
PATIENTS AND METHODS
This prespecified retrospective analysis included 199 evaluable patients with RAS / BRAF wt. The PRESSING panel included the following: immunohistochemistry (IHC) and in situ hybridization for HER2/MET amplification, IHC with or without RNA sequencing for ALK/ROS1/NTRKs/RET fusions, next-generation sequencing for HER2 / PIK3CAex.20/PTEN / AKT1 and RAS mutations with low mutant allele fraction, and multiplex polymerase chain reaction for microsatellite instability. PRESSING status (any positive biomarker v all negative) and sidedness were correlated with overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) in the study population and by treatment arm.
RESULTS
Overall, left- and right-sided tumors were 85.4% and 14.6%, respectively, and PRESSING-negative and -positive tumors were 75.4% and 24.6%, respectively. At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2% v 74.1%; P = .037), PFS (8.4 v 11.5 months; P = .026), and OS (2-year rate: 50.2% v 65.1%; P = .062). Similar results were observed in the PRESSING-positive versus PRESSING-negative subgroup for ORR (59.2% v 75.3%; P = .030), PFS (7.7 v 12.1 months; P < .001), and OS (2-year rate: 48.1% v 68.1%; P = .021). The PFS benefit of FU plus LV added to panitumumab maintenance, reported in the study, was independent from sidedness and PRESSING status (interaction for PFS P = .293 and .127, respectively). However, outcomes were extremely poor in patients who received single-agent panitumumab and had right-sided tumors (median PFS, 7.7 months; 2-year OS, 38.5%) or PRESSING-positive tumors (median PFS, 7.4 months; 2-year OS, 47.0%).
CONCLUSION
The combined assessment of sidedness and molecular alterations of anti-EGFR primary resistance identified a consistent proportion of patients with RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs.",2019,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2% v 74.1%; P = .037), PFS (8.4 v 11.5 months; P = .026), and OS (2-year rate: 50.2% v 65.1%; P = .062).","['199 evaluable patients with RAS / BRAF wt', 'Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer', 'patients with RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs', 'metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with RAS / BRAF wild-type (wt) metastatic colorectal cancer (mCRC']","['Panitumumab-Based Maintenance Therapy', 'panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino']","['Overall, left- and right-sided tumors', 'overall response rate (ORR), progression-free survival (PFS), and overall survival (OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",199.0,0.168706,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2% v 74.1%; P = .037), PFS (8.4 v 11.5 months; P = .026), and OS (2-year rate: 50.2% v 65.1%; P = .062).","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'University of Pisa, Pisa, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Humanitas Cancer Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Murialdo', 'Affiliation': 'University of Genoa and IRCCS Azienda Ospedaliera Universitaria (AOU) San Martino-IST, Genoa, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sartore-Bianchi', 'Affiliation': 'Niguarda Cancer Center, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Azienda Socio-Sanitaria Territoriale Ospedale di Cremona, Cremona, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Racca', 'Affiliation': 'AOU Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Clavarezza', 'Affiliation': 'Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Adamo', 'Affiliation': 'University of Messina, Messina, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Annunziata', 'Initials': 'A', 'LastName': 'Gloghini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tamborini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Busico', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Palermo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Milione', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01254']
2218,32422456,Cognitive and emotional predictors of real versus sham repetitive transcranial magnetic stimulation treatment response in methamphetamine use disorder.,"BACKGROUND AND AIMS
Repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (DLPFC) can effectively reduce cravings in methamphetamine use disorder (MUD). However, a considerable group still fails to respond. Cognitive and emotional disturbance, as well as impulsive features, are widespread in patients with MUD and might mediate the treatment response of rTMS. The purpose of this study is to figure out whether these variables can help predicting patients' responses to rTMS treatment.
METHODS
Ninety-seven patients with severe MUD and thirty-one gender- and age-matched healthy subjects were included. Patients were randomized to receive 20 sessions of real or sham rTMS. Intermittent theta burst protocols (iTBS) or sham iTBS were applied every weekday over the DLPFC for 20 daily sessions. Both groups received regular treatment. Craving induced by drug-related cue was measured before and after stimulation. Cognition was evaluated by using the CogState Battery. Baseline characteristics were collected through the Addiction Severity Index, Patient Health Questionnaire-9, General Anxiety Disorder Scale-7, and Barrett Impulsivity Scale-11.
RESULTS
Results showed that patients with MUD have worse spatial working memory, problem-solving ability, as well as depression and anxiety symptoms compared with healthy controls. Cognition and emotion differed between responders (craving decrease ≥60%) and non-responders in real rTMS group but not in the sham group. Better cognitive and emotional functions means that patients have higher possibility for better response to real rTMS treatment.
CONCLUSIONS
This study suggests that cognitive, emotional and impulsive features could be used to predict the prospective treatment responses of rTMS in patients with MUD.",2020,Cognition and emotion differed between responders (craving decrease ≥60%) and non-responders in real rTMS group but not in the sham group.,"['methamphetamine use disorder', 'Ninety-seven patients with severe MUD and thirty-one gender- and age-matched healthy subjects were included', 'patients with MUD']","['Intermittent theta burst protocols (iTBS) or sham iTBS', 'Repetitive transcranial magnetic stimulation (rTMS', '20 sessions of real or sham rTMS', 'real versus sham repetitive transcranial magnetic stimulation', 'rTMS']","['Craving', 'spatial working memory, problem-solving ability', 'Cognitive and emotional disturbance', 'depression and anxiety symptoms', 'Cognition and emotion']","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0013985', 'cui_str': 'Emotional Disturbances'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",97.0,0.0306309,Cognition and emotion differed between responders (craving decrease ≥60%) and non-responders in real rTMS group but not in the sham group.,"[{'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Yunnan Institute on Drug Dependence, Yunnan, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Duan', 'Affiliation': 'Yunnan Institute on Drug Dependence, Yunnan, China.'}, {'ForeName': 'Congbin', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Yunnan Institute on Drug Dependence, Yunnan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology (CEBSIT), Chinese Academy of Sciences, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.007']
2219,22144920,Effects of local low-dose rocuronium on the quality of peribulbar anesthesia for cataract surgery.,"OBJECTIVES
Peribulbar anesthesia is associated with delayed and/or incomplete orbital akinesia compared with retrobulbar anesthesia. This study examined the effects of adding rocuronium 5 mg to two different concentrations of lidocaine-bupivacaine mixture on onset time of orbital and eyelid akinesia in patients undergoing cataract surgery.
METHODS
In a double-blind study, 90 patients were equally randomized to receive a mixture of 0.5 ml normal saline, 4 ml lidocaine 2%, and 4 ml bupivacaine 0.5% (group I), a mixture of rocuronium 0.5 ml (5 mg), 4 ml lidocaine 2%, and 4 ml bupivacaine 0.5% (group II), or a mixture of rocuronium 0.5 ml (5 mg), 4 ml lidocaine 1%, and 4 ml bupivacaine 0.25% (group III). Orbital akinesia was assessed on a 0-8 score (0 = no movement, 8 = normal) at 2 min intervals for 10 min. Time to adequate anesthesia was also recorded. Results are presented as mean±SD.
RESULTS
Ocular movement score decreased during the assessment period in all groups. However, at 2 min after block administration, the score decreased to 4±2 (95% CI 3,5) in groups II and III compared with 5±2 (95% CI 4,6) in group I (P<0.01). Time to adequate condition to begin surgery was 9.8±2.9 vs. 6.9±4.1 vs. 7.9±3.9 min for groups I, II, and III, respectively (P=0.01).
CONCLUSION
The addition of rocuronium 5 mg to a mixture of lidocaine 2% and bupivacaine 0.5% shortened the onset time of peribulbar anesthesia in patients undergoing cataract surgery without causing adverse effects.",2011,"Time to adequate condition to begin surgery was 9.8±2.9 vs. 6.9±4.1 vs. 7.9±3.9 min for groups I, II, and III, respectively (P=0.01).
","['90 patients', 'patients undergoing cataract surgery without causing adverse effects', 'cataract surgery', 'patients undergoing cataract surgery']","['rocuronium 0.5 ml (5 mg), 4 ml lidocaine', 'retrobulbar anesthesia', 'lidocaine', 'rocuronium', 'bupivacaine', 'mixture of rocuronium 0.5 ml (5 mg), 4 ml lidocaine', 'local low-dose rocuronium', 'lidocaine-bupivacaine mixture', 'mixture of 0.5 ml normal saline, 4 ml lidocaine']","['Ocular movement score', 'onset time of orbital and eyelid akinesia', 'onset time of peribulbar anesthesia', 'Orbital akinesia', 'Time to adequate condition to begin surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0699036', 'cui_str': 'Orbital (qualifier value)'}, {'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0085623', 'cui_str': 'Akinesia (finding)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",90.0,0.342234,"Time to adequate condition to begin surgery was 9.8±2.9 vs. 6.9±4.1 vs. 7.9±3.9 min for groups I, II, and III, respectively (P=0.01).
","[{'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Anesthesia, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'El Shahawy', 'Affiliation': ''}, {'ForeName': 'Ahmed I', 'Initials': 'AI', 'LastName': 'Ahmed', 'Affiliation': ''}, {'ForeName': 'Waleed A', 'Initials': 'WA', 'LastName': 'Almarakbi', 'Affiliation': ''}, {'ForeName': 'Jamal A', 'Initials': 'JA', 'LastName': 'Alhashemi', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.87263']
2220,22144922,Comparative evaluation of dexmedetomidine and fentanyl for epidural analgesia in lower limb orthopedic surgeries.,"BACKGROUND AND AIMS
Opioids as epidural adjunct to local anesthetics (LA) have been in use since long and α-2 agonists are being increasingly used for similar purpose. The present study aims at comparing the hemodynamic, sedative, and analgesia potentiating effects of epidurally administered fentanyl and dexmedetomidine when combined with ropivacaine.
METHODS
A total of one hundred patients of both gender aged 21-56 years, American Society of Anaesthesiologist (ASA) physical status I and II who underwent lower limb orthopedic surgery were enrolled into the present study. Patients were randomly divided into two groups: Ropivacaine + Dexmedetomidine (RD) and Ropivacaine + Fentanyl (RF), comprising 50 patie nts each. Inj. Ropivacaine, 15 ml of 0.75%, was administered epidurally in both the groups with addition of 1 μg/kg of dexmedetomidine in RD group and 1 μg/kg of fentanyl in RF group. Besides cardio-respiratory parameters and sedation scores, various block characteristics were also observed which included time to onset of analgesia at T10, maximum sensory analgesic level, time to complete motor blockade, time to two segmental dermatomal regressions, and time to first rescue analgesic. At the end of study, data was compiled systematically and analyzed using ANOVA with post-hoc significance, Chi-square test and Fisher's exact test. Value of P<0.05 is considered significant and P<0.001 as highly significant.
RESULTS
The demographic profile of patients was comparable in both the groups. Onset of sensory analgesia at T10 (7.12±2.44 vs 9.14±2.94) and establishment of complete motor blockade (18.16±4.52 vs 22.98±4.78) was significantly earlier in the RD group. Postoperative analgesia was prolonged significantly in the RD group (366.62±24.42) and consequently low dose consumption of local anaesthetic LA (76.82±14.28 vs 104.35±18.96) during epidural top-ups postoperatively. Sedation scores were much better in the RD group and highly significant on statistical comparison (P<0.001). Incidence of nausea and vomiting was significantly high in the RF group (26% and 12%), while incidence of dry mouth was significantly higher in the RD group (14%) (P<0.05).
CONCLUSIONS
Dexmedetomidine seems to be a better alternative to fentanyl as an epidural adjuvant as it provides comparable stable hemodynamics, early onset, and establishment of sensory anesthesia, prolonged post-op analgesia, lower consumption of post-op LA for epidural analgesia, and much better sedation levels.",2011,Sedation scores were much better in the RD group and highly significant on statistical comparison (P<0.001).,"['lower limb orthopedic surgeries', 'A total of one hundred patients of both gender aged 21-56 years, American Society of Anaesthesiologist (ASA) physical status I and II who underwent lower limb orthopedic surgery were enrolled into the present study']","['Dexmedetomidine', 'dexmedetomidine and fentanyl', 'Ropivacaine + Dexmedetomidine (RD) and Ropivacaine + Fentanyl (RF', 'ropivacaine', 'fentanyl and dexmedetomidine', 'Ropivacaine', 'dexmedetomidine']","['time to onset of analgesia at T10, maximum sensory analgesic level, time to complete motor blockade, time to two segmental dermatomal regressions, and time to first rescue analgesic', 'incidence of dry mouth', 'Incidence of nausea and vomiting', 'Sedation scores', 'establishment of complete motor blockade', 'Postoperative analgesia', 'low dose consumption of local anaesthetic LA']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}]",100.0,0.0676843,Sedation scores were much better in the RD group and highly significant on statistical comparison (P<0.001).,"[{'ForeName': 'Sukhminder Jit Singh', 'Initials': 'SJ', 'LastName': 'Bajwa', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Gian Sagar Medical College and Hospital, Ram Nagar, Banur, Punjab, India.'}, {'ForeName': 'Vikramjit', 'Initials': 'V', 'LastName': 'Arora', 'Affiliation': ''}, {'ForeName': 'Jasbir', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Amarjit', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Parmar', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.87264']
2221,22144923,Maternal and neonatal effects of nalbuphine given immediately before induction of general anesthesia for elective cesarean section.,"BACKGROUND
Although nalbuphine was studied extensively in labour analgesia and was proved to be acceptable analgesics during delivery, its use as premedication before induction of general anesthesia for cesarean section is not studied. The aim of this study was to evaluate the effect of nalbuphine given before induction of general anesthesia for cesarean section on quality of general anesthesia, maternal stress response, and neonatal outcome.
METHODS
Sixty full term pregnant women scheduled for elective cesarean section, randomly classified into two equal groups, group N received nalbuphine 0.2 mg/kg diluted in 10 ml of normal saline (n=30), and group C placebo (n=30) received 10 ml of normal saline 1 min before the induction of general anesthesia. Maternal heart rate and blood pressure were measured before, after induction, during surgery, and after recovery. Neonates were assisted by using APGAR0 scores, time to sustained respiration, and umbilical cord blood gas analysis.
RESULT
Maternal heart rate showed significant increase in control group than nalbuphine group after intubation (88.2±4.47 versus 80.1±4.23, P<0.0001) and during surgery till delivery of baby (90.8±2.39 versus 82.6±2.60, P<0.0001) and no significant changes between both groups after delivery. MABP increased in control group than nalbuphine group after intubation (100.55±6.29 versus 88.75±6.09, P<0.0001) and during surgery till delivery of baby (98.50±2.01 versus 90.50±2.01, P<0.0001) and no significant changes between both groups after delivery. APGAR score was significantly low at one minute in nalbuphine group than control group (6.75±2.3, 8.5±0.74, respectively, P=0.0002) (27% of nalbuphine group APGAR score ranged between 4-6, while 7% in control group APGAR score ranged between 4-6 at one minute). All neonates at five minutes showed APGAR score ranged between 9-10. Time to sustained respiration was significantly longer in nalbuphine group than control group (81.8±51.4 versus 34.9±26.2 seconds, P<0.0001). The umbilical cord blood gas was comparable in both groups. None of the neonates need opioid antagonist (naloxone) or endotracheal intubation.
CONCLUSION
Administration of nalbuphine before cesarean section under general anesthesia reduces maternal stress response related to intubation and surgery, but decreases the APGAR score at one minute after delivery. So, when nalbuphine was used, all measures for neonatal monitoring and resuscitation must be available including attendance of a pediatrician.",2011,"MABP increased in control group than nalbuphine group after intubation (100.55±6.29 versus 88.75±6.09, P<0.0001) and during surgery till delivery of baby (98.50±2.01 versus 90.50±2.01, P<0.0001) and no significant changes between both groups after delivery.","['Sixty full term pregnant women scheduled for elective cesarean section', 'general anesthesia for elective cesarean section']","['10 ml of normal saline', 'placebo', 'nalbuphine', 'opioid antagonist (naloxone', 'nalbuphine 0.2 mg/kg diluted in 10 ml of normal saline']","['Maternal heart rate and blood pressure', 'Maternal heart rate', 'umbilical cord blood gas', 'APGAR0 scores, time to sustained respiration, and umbilical cord blood gas analysis', 'quality of general anesthesia, maternal stress response, and neonatal outcome', 'Time to sustained respiration', 'MABP', 'maternal stress response', 'APGAR score']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}]",60.0,0.143178,"MABP increased in control group than nalbuphine group after intubation (100.55±6.29 versus 88.75±6.09, P<0.0001) and during surgery till delivery of baby (98.50±2.01 versus 90.50±2.01, P<0.0001) and no significant changes between both groups after delivery.","[{'ForeName': 'Sabry M', 'Initials': 'SM', 'LastName': 'Amin', 'Affiliation': 'Department of Anesthesia, Tanta University Hospital, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Amr', 'Affiliation': ''}, {'ForeName': 'Sameh M', 'Initials': 'SM', 'LastName': 'Fathy', 'Affiliation': ''}, {'ForeName': 'Ashraf E', 'Initials': 'AE', 'LastName': 'Alzeftawy', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.87265']
2222,22144925,Addition of intrathecal Dexamethasone to Bupivacaine for spinal anesthesia in orthopedic surgery.,"OBJECTIVES
Spinal anesthesia has the advantage that profound nerve block can be produced in a large part of the body by the relatively simple injection of a small amount of local anesthetic. Intrathecal local anesthetics have limited duration. Different additives have been used to prolong spinal anesthesia. The effect of corticosteroids in prolonging the analgesic effects of local anesthetics in peripheral nerves is well documented. The purpose of this investigation was to determine whether the addition of dexamethasone to intrathecal bupivacaine would prolong the duration of sensory analgesia or not.
METHODS
We conducted a randomized, prospective, double-blind, case-control, clinical trial. A total of 50 patients were scheduled for orthopedic surgery under spinal anesthesia. The patients were randomly allocated to receive 15 mg hyperbaric bupivacaine 0.5% with 2 cc normal saline (control group) or 15 mg hyperbaric bupivacaine 0.5% plus 8 mg dexamethasone (case group) intrathecally. The patients were evaluated for quality, quantity, and duration of block; blood pressure, heart rate, nausea, and vomiting or other complications.
RESULTS
There were no signification differences in demographic data, sensory level, and onset time of the sensory block between two groups. Sensory block duration in the case group was 119±10.69 minutes and in the control group was 89.44±8.37 minutes which was significantly higher in the case group (P<0.001). The duration of analgesia was 401.92±72.44 minutes in the case group; whereas it was 202±43.67 minutes in the control group (P<0.001). The frequency of complications was not different between two groups.
CONCLUSION
This study has shown that the addition of intrathecal dexamethasone to bupivacaine significantly improved the duration of sensory block in spinal anesthesia without any changes in onset time and complications.",2011,"There were no signification differences in demographic data, sensory level, and onset time of the sensory block between two groups.","['spinal anesthesia in orthopedic surgery', '50 patients were scheduled for orthopedic surgery under spinal anesthesia']","['hyperbaric bupivacaine 0.5% with 2 cc normal saline (control group) or 15 mg hyperbaric bupivacaine 0.5% plus 8 mg dexamethasone', 'intrathecal Dexamethasone', 'dexamethasone', 'intrathecal dexamethasone', 'bupivacaine', 'corticosteroids', 'Bupivacaine']","['duration of sensory analgesia or not', 'Sensory block duration', 'duration of sensory block', 'quality, quantity, and duration of block; blood pressure, heart rate, nausea, and vomiting or other complications', 'demographic data, sensory level, and onset time of the sensory block', 'duration of analgesia', 'frequency of complications']","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",50.0,0.215438,"There were no signification differences in demographic data, sensory level, and onset time of the sensory block between two groups.","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bani-Hashem', 'Affiliation': 'Department of Anesthesiology, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Hassan-Nasab', 'Affiliation': ''}, {'ForeName': 'Ebrahim Alijan', 'Initials': 'EA', 'LastName': 'Pour', 'Affiliation': ''}, {'ForeName': 'Parviz Amri', 'Initials': 'PA', 'LastName': 'Maleh', 'Affiliation': ''}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Nabavi', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jabbari', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.87267']
2223,21957400,Anesthesiologists work-related exhaustion: A comparison study with other hospital employees.,"BACKGROUND
Anesthesia is a demanding occupation due to long working hours, sustained vigilance, unpredictability of stressful situation, fear of litigation, competence, and production pressure. Work-related exhaustion can lead to several physical and psychological symptoms and delay decision making. The aim of this study was to evaluate how different work conditions affect personnel exhaustion by studying a sample of anesthesiologists comparing them with ophthalmologists and ancillary hospital staff
METHODS
One hundred fifty persons divided into three equal groups (50 each) were invited to participate in this study. Subjects were asked to answer two self report questionnaires: The Multidimensional Fatigue Inventory (MFI-20) and General Health Questionnaire (GHQ-12) which used to assess work related exhaustion and mental health, respectively.
RESULTS
Multidimensional Fatigue Inventory scale (MFI 20) and General Health Questionnaire (GHQ 12) were significantly higher in anesthesiologists than in other groups (P = 0.001). Different aspects of work-related exhaustion showed that general, physical and mental fatigue were significantly higher in anesthesiologists (P = 0.002 and 0.001, respectively). Reduced activity and reduced motivation were also higher in anesthesiologists compare to the other groups (P = 0.005 and 0.001, respectively).
CONCLUSION
Work-related exhaustion under the current study is more obvious among anesthesiologists. Ophthalmologist and ancillary hospital employees felt that they had less stress at their work.",2011,"Reduced activity and reduced motivation were also higher in anesthesiologists compare to the other groups (P = 0.005 and 0.001, respectively).
",['One hundred fifty persons divided into three equal groups (50 each) were invited to participate in this study'],[],"['Reduced activity and reduced motivation', 'Multidimensional Fatigue Inventory scale (MFI 20) and General Health Questionnaire (GHQ 12', 'general, physical and mental fatigue', 'Multidimensional Fatigue Inventory (MFI-20) and General Health Questionnaire (GHQ-12']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}]",150.0,0.0259707,"Reduced activity and reduced motivation were also higher in anesthesiologists compare to the other groups (P = 0.005 and 0.001, respectively).
","[{'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Riad', 'Affiliation': 'Department of Anesthesia, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Afaf', 'Initials': 'A', 'LastName': 'Mansour', 'Affiliation': ''}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moussa', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.84095']
2224,22412769,A comparison of midazolam and clonidine as an oral premedication in pediatric patients.,"BACKGROUND
To compare oral midazolam (0.5 mg/kg) versus oral clonidine (4 μg/kg) as a premedication in pediatric patients aged between 2-12 years with regard to sedation and anxiolysis.
METHODS
Sixty pediatric patients belonging to the American Society of Anesthesiologists class I and II between the age group of 2-12 years scheduled for elective surgery were randomly allocated to receive either oral midazolam (group I) 30 min before induction or oral clonidine (group II) 90 min before induction of anesthesia. The children were evaluated for levels of sedation and anxiety at the time of separation from the parents, venepuncture, and at the time of mask application for induction of anesthesia.
RESULTS
After premedication, the percentage of children who were sedated and calm increased in both the groups. The overall level of sedation was better in the children in the clonidine group, but children in the midazolam group had a greater degree of anxiolysis at times of venepuncture and mask application. In addition, midazolam did not cause significant changes in hemodynamics unlike clonidine where a significant fall in blood pressure was noted, after premedication, but preinduction.
CONCLUSION
We conclude that under the conditions of the study, oral midazolam is superior to clonidine as an anxiolytic in pediatric population. Clonidine with its sedative action especially at the time of separation from parents along with its other perioperative benefits cannot be discounted.",2012,"The overall level of sedation was better in the children in the clonidine group, but children in the midazolam group had a greater degree of anxiolysis at times of venepuncture and mask application.","['pediatric patients aged between 2-12 years with regard to sedation and anxiolysis', 'I and II between the age group of 2-12 years scheduled for elective surgery', 'pediatric population', 'pediatric patients', 'Sixty pediatric patients belonging to the American Society of Anesthesiologists class']","['oral midazolam', 'midazolam', 'midazolam and clonidine', 'clonidine', 'oral clonidine', 'Clonidine']","['levels of sedation and anxiety', 'blood pressure', 'overall level of sedation', 'degree of anxiolysis']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1961138', 'cui_str': 'Anxiolysis'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1961138', 'cui_str': 'Anxiolysis'}]",60.0,0.031491,"The overall level of sedation was better in the children in the clonidine group, but children in the midazolam group had a greater degree of anxiolysis at times of venepuncture and mask application.","[{'ForeName': 'Sequeira', 'Initials': 'S', 'LastName': 'Trevor', 'Affiliation': 'Department of Anaesthesia, Kasturba Medical College, Mangalore, Karnataka, India.'}, {'ForeName': 'Madhusudan', 'Initials': 'M', 'LastName': 'Upadya', 'Affiliation': ''}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Sinha', 'Affiliation': ''}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.93045']
2225,32423584,"Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.","BACKGROUND
No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models.
METHODS
We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2-10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04257656.
FINDINGS
Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87-1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95-2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.
INTERPRETATION
In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.
FUNDING
Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project.",2020,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"['Between Feb 6, 2020, and March 12, 2020, 237 patients', 'Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia', 'adults with severe COVID-19', 'patients with severe coronavirus disease 2019 (COVID-19', 'ten hospitals in Hubei, China']","['lopinavir-ritonavir, interferons, and corticosteroids', 'intravenous remdesivir', 'placebo']","['time to clinical improvement', 'six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first', 'Adverse events', 'intention-to-treat (ITT) population and safety analysis', 'adverse events']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",237.0,0.583704,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"[{'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shouzhi', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhenshun', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qiaofa', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Chengqing', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Mei', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xianzhi', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Tsinghua University School of Medicine, Beijing, China.'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Teddy Clinical Research Laboratory, Shanghai, China.'}, {'ForeName': 'Yushen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Hangzhou DI'AN Medical Laboratory, Hangzhou, China.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University, Lancaster, UK; University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'International Severe Acute Respiratory and Emerging Infection Consortium, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China. Electronic address: caobin_ben@163.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China; Peking Union Medical College, Beijing, China. Electronic address: wangchen@pumc.edu.cn.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31022-9']
2226,32421737,Predictors of change of health workers' knowledge and skills after the Helping Mothers Survive Bleeding after Birth (HMS BAB) in-facility training in Tanzania.,"BACKGROUND
Our study aimed to assess the effect of Helping Mothers Survive Bleeding after Birth on knowledge and skills of health workers and whether such effect varies by health workers characteristics.
METHODS
Nested in a cluster-randomised trial to assess the effect of the training on health outcomes, we assessed changes in knowledge and simulated skills in 61 facilities. The assessments were done i) before, ii) immediately-after training session and iii) at 10-month follow-up for subset of health-workers of implementation facilities as defined by the trial. We used a self-administered questionnaire and Objective Structures Clinical Examinations to assess three skill sets: Active Management of Third Stage of Labour, removal of retained placenta and management of severe postpartum haemorrhage. We computed summary statistics and used the paired t-test to assess change of knowledge and skills immediately post-training and at 10-month follow-up. Linear regression was done to assess association of scores and health worker characteristics.
RESULTS
Of the 636 health workers included, 606 (96.7%) and 591 (91.4%) completed the knowledge and skills assessments, respectively. Majority of the participants (68%) were nurse-midwives. Knowledge scores increased by 15 percentage-points from 77.5% to 93% (95% CI 14.3, 16.3, p-value <0.000), and skills scores by 47 percentage-points (95% CI 46.5, 49.2, p-value <0.000) from 37.5% to 83%. There was a 4.0% decline of skills at 10-month follow-up. The decline was higher in auxiliary staff (-11.8%) and least in nurse-midwives (-2.1%) p-value <0.001. Health workers who assisted less than 5 deliveries in the last month, those who never attended postpartum haemorrhage in-service training and profession experience >8 years were associated with lower mean skill change immediately post-training.
CONCLUSION
Our study supports the potential of the Helping Mothers Survive Bleeding after Birth training to increase knowledge and skills of postpartum haemorrhage among all professional groups. Auxiliary staff benefited most from the training but also showed higher skill decline at 10-month. Our study highlights the importance to disaggregate knowledge and skills by health workers characteristics.",2020,"Knowledge scores increased by 15 percentage-points from 77.5% to 93% (95% CI 14.3, 16.3, p-value <0.000), and skills scores by 47 percentage-points (95% CI 46.5, 49.2, p-value <0.000) from 37.5% to 83%.","['61 facilities', 'Health workers who assisted less than 5 deliveries in the last month, those who never attended postpartum haemorrhage in-service training and profession experience >8 years', 'Of the 636 health workers', 'Mothers Survive Bleeding after Birth (HMS BAB) in-facility training in Tanzania']",[],"['knowledge and skills of postpartum haemorrhage', 'Knowledge scores', 'auxiliary staff', 'skills scores', 'skill decline']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557286', 'cui_str': 'No formal education'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",,0.0861455,"Knowledge scores increased by 15 percentage-points from 77.5% to 93% (95% CI 14.3, 16.3, p-value <0.000), and skills scores by 47 percentage-points (95% CI 46.5, 49.2, p-value <0.000) from 37.5% to 83%.","[{'ForeName': 'Fadhlun', 'Initials': 'F', 'LastName': 'Alwy Al-Beity', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Andrea Barnabas', 'Initials': 'AB', 'LastName': 'Pembe', 'Affiliation': 'Department of Obstetrics and Gynaecology, Muhimbili University of Health and Allied Sciences, Dar es salaam, Tanzania.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Marrone', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Baker', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hanson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0232983']
2227,32422244,"Implementation of basic life support training for school children: Online education for potential instructors? Results of a cluster randomised, controlled, non-inferiority trial.","AIM OF THE STUDY
Comprehensive training of the population in basic life support (BLS) increases the chance of survival in cardiac arrest. To implement BLS trainings at schools a high number of instructors will be needed. This non-inferiority study investigated, if online education is effective to prepare instructors to teach BLS compared to face-to-face education.
METHODS
A cluster randomised, controlled, single blinded study was performed in 2018 in Hamburg, Germany. A mixed group of potential instructors were allocated alternately to either the intervention or control group and participated in a four-hour instructor training. The instructor training of the control group was realised by trained educators. The intervention group participated in a self-regulated online training with hands-on training supported by peers. Instructors provided BLS training for high school students. The primary endpoint was a mean score in the BLS skills assessment of the students. The secondary endpoint was teaching effectiveness of the instructors.
RESULTS
BLS assessments of 808 students of 46 classes, who were taught by 74 instructors could be analysed. The students trained by interventional instructors achieved 0.14 points less (95% CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48). The non-inferiority could not be confirmed. The teaching performance in the intervention group was better in some aspects compared to the control group.
CONCLUSION
Integrating all results of this study, online education may be an effective alternative to prepare potential BLS instructors. Using free online courses, motivated persons can independently acquire necessary skills to become instructors and autonomously realise low cost BLS trainings at schools.",2020,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"['808 students of 46 classes, who were taught by 74 instructors could be analysed', '2018 in Hamburg, Germany', 'high school students', 'school children']","['Basic life support training', 'BLS training', 'self-regulated online training with hands-on training supported by peers', 'intervention or control group and participated in a four-hour instructor training']","['mean score in the BLS skills assessment of the students', 'teaching effectiveness of the instructors']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",,0.042077,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Napp', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Kosan', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hoffend', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Häge', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Breitfeld', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Doehn', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kubitz', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Beck', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany. Electronic address: st.beck@uke.de.'}]",Resuscitation,['10.1016/j.resuscitation.2020.04.041']
2228,21804802,Effect of bupivacaine concentration on the efficacy of ultrasound-guided interscalene brachial plexus block.,"BACKGROUND
Interscalene brachial plexus block (ISBPB) is an effective technique for shoulder surgery and postoperative pain control. The aim of this study is to compare the analgesic efficacy of 0.1% vs 0.2% bupivacaine for continuous postoperative pain control following arthroscopic shoulder surgery.
METHODS
A total of 40 adult patients divided into two groups (each 20 patients) undergoing arthroscopic shoulder surgery were randomized to receive an ultrasound-guided ISBPB of either 0.1% or 0.2% bupivacaine 10 ml bolus plus 5 ml/h infusion through interscalene catheter. Standard general anesthesia was given. Both groups received rescue postoperative PCA morphine. Pain, sensory, and motor power were assessed before for all patients, 20 minute after the block, postoperatively in the recovery room, and at 2, 6, 12, and 24 hours thereafter. The patient and surgeon satisfaction and the analgesic consumption of morphine were recorded in the first 24 hours postoperatively. A nonparametric Mann-Whitney was used to compare between the two groups for numerical rating scale, morphine consumption in different time interval.
RESULTS
Group 1 (0.1% bupivacaine) patients had significantly received more intraoperative fentanyl and postoperative morphine with higher pain scores at 24 hours postoperatively vs group 2 (0.2% bupivacaine) patients.
CONCLUSIONS
The use of ultrasound-guided ISBPB with 0.2% bupivacaine provided better intra- and post-operative pain relief vs 0.1% bupivacaine in arthroscopic shoulder surgery.",2011,The use of ultrasound-guided ISBPB with 0.2% bupivacaine provided better intra- and post-operative pain relief vs 0.1% bupivacaine in arthroscopic shoulder surgery.,"['arthroscopic shoulder surgery', '40 adult patients divided into two groups (each 20 patients) undergoing arthroscopic shoulder surgery']","['Interscalene brachial plexus block (ISBPB', 'ultrasound-guided interscalene brachial plexus block', 'bupivacaine', 'ultrasound-guided ISBPB of either 0.1% or 0.2% bupivacaine 10 ml bolus plus 5 ml/h infusion through interscalene catheter', 'ultrasound-guided ISBPB with 0.2% bupivacaine', 'rescue postoperative PCA morphine']","['intraoperative fentanyl and postoperative morphine with higher pain scores', 'analgesic consumption of morphine', 'analgesic efficacy', 'numerical rating scale, morphine consumption', 'Pain, sensory, and motor power']","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439391', 'cui_str': 'mL/h'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]",40.0,0.0955517,The use of ultrasound-guided ISBPB with 0.2% bupivacaine provided better intra- and post-operative pain relief vs 0.1% bupivacaine in arthroscopic shoulder surgery.,"[{'ForeName': 'Alzahrani', 'Initials': 'A', 'LastName': 'Tariq', 'Affiliation': 'Department of Anesthesiology, College of Medicine, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Al-Ahaideb', 'Initials': 'AA', 'LastName': 'Abdulaziz', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82798']
2229,21804803,Comparison of respiratory quotient and resting energy expenditure in two regimens of enteral feeding - continuous vs. intermittent in head-injured critically ill patients.,"INTRODUCTION
Measurement of respiratory quotient (RQ) and resting energy expenditure (REE) has been shown to be helpful in designing nutritional regimens. There is a paucity of the literature describing the impact of a feeding regimen on the energy expenditure patterns. Therefore, we studied the effect of continuous vs. intermittent feeding regimen in head-injured patients on mechanical ventilation on RQ and REE.
METHODS
After institutional ethical approval, this randomized study was conducted in 40 adult male patients with head injury requiring controlled mode of ventilation. Patients were randomly allocated into two groups. Group C: Feeds (30 kcal/kg/day) were given for 18 h/day, with night rest for 6 h. Group I: Six bolus feeds (30 kcal/kg/day) were given three hourly for 18 h with night rest for 6 h. RQ and REE were recorded every 30 min for 24 h. Blood sugar was measured 4 hourly. Other adverse effects such as feed intolerance, aspiration were noted.
RESULTS
Demographic profile and SOFA score were comparable in the two groups. Base line RQ (0.8 vs. 0.86) and REE (1527 vs. 1599 kcal/day) were comparable in both the groups (P>0.05). RQ was comparable in both groups during the study period at any time of the day (P>0.05). Base line RQ was compared with all other RQ values measured every half hour and fluctuation from the base line value was insignificant in both groups (P>0.05). REE was comparable in both the groups throughout the study period (P>0.5). Adequacy of feeding as assessed by EI/MREE was 105.7% and 105.3% in group C and group I, respectively. There was no significant difference in the blood sugar levels between the two groups (P>0.05).
CONCLUSION
We found from our study that RQ, REE, and blood sugar remain comparable with two regimens of enteral feeding - continuous vs. intermittent in neurosurgical patients on ventilator support in a ICU setup.",2011,RQ was comparable in both groups during the study period at any time of the day (P>0.05).,"['head-injured patients on mechanical ventilation on RQ and REE', '40 adult male patients with head injury requiring controlled mode of ventilation', 'head-injured critically ill patients']","['respiratory quotient (RQ) and resting energy expenditure (REE', 'enteral feeding - continuous vs. intermittent']","['Adequacy of feeding as assessed by EI/MREE', 'Demographic profile and SOFA score', 'RQ', 'blood sugar levels', 'REE']","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood (procedure)'}]",40.0,0.0305862,RQ was comparable in both groups during the study period at any time of the day (P>0.05).,"[{'ForeName': 'Indubala', 'Initials': 'I', 'LastName': 'Maurya', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Postgraduate Institute of Medical Education and Research, Dr. Ram Manohar Lohia Hospital, New Delhi, India.'}, {'ForeName': 'Mridula', 'Initials': 'M', 'LastName': 'Pawar', 'Affiliation': ''}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Mohandeep', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sood', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82800']
2230,21655020,"Evaluating ranitidine, pantoprazole and placebo on gastric pH in elective surgery.","BACKGROUND AND AIM
Concern about the grim nature of postoperative acid aspiration syndrome grew among the anesthesiologist over the years warranting the need for pre-emptive intervention. The aim of the study is to compare the effects of preoperative oral ranitidine versus pantoprazole given in regulating gastric pH in elective surgery.
METHODS
This prospective, parallel group, controlled, randomized, single-blind study was conducted at a tertiary care postgraduate teaching institute at Kolkata, involving 120 participants of either sex, aged 18-60 years of American Society of Anesthesiologists physical status I and II, who were scheduled for elective surgery under general anesthesia lasting for more than 2 h. The participants were divided into three groups. In group A (n=40) participants received placebo tablet, in group B (n=40) participants received ranitidine tablet while in group C (n=40), participants received pantoprazole tablet and their gastric pH estimated serially.
RESULTS
The participants in the three groups were comparable in terms of age, sex, body weight, duration of surgery and type of surgery distribution. In regard to changes in gastric pH trends, there was no statistically significant difference between serial pH values in group A (Friedman test; P>0.05) and group C participants. (P>0.05). However, the mean preoperative gastric pH values (7.140±.7652) were significantly lower than mean pH values (7.253±.7514) after 2 h postoperatively in group B participants (P<0.05).
CONCLUSION
From the observations and analyses of the present study, it can be inferred that ranitidine is more effective than pantoprazole to raise the gastric pH for prevention of aspiration pneumonitis.",2011,"The participants in the three groups were comparable in terms of age, sex, body weight, duration of surgery and type of surgery distribution.","['tertiary care postgraduate teaching institute at Kolkata, involving 120 participants of either sex, aged 18-60 years of American Society of Anesthesiologists physical status I and II, who were scheduled for elective surgery under general anesthesia lasting for more than 2 h', 'elective surgery']","['pantoprazole tablet and their gastric pH estimated serially', 'ranitidine', 'ranitidine tablet', 'pantoprazole', 'placebo tablet', 'ranitidine, pantoprazole and placebo']","['gastric pH', 'mean preoperative gastric pH values', 'serial pH values']","[{'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0034665', 'cui_str': 'Ranitidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",120.0,0.0595144,"The participants in the three groups were comparable in terms of age, sex, body weight, duration of surgery and type of surgery distribution.","[{'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Anaesthesiology, Institute of Postgraduate Medical Education & Research (IPGME&R), Kolkata, India.'}, {'ForeName': 'Debabrata', 'Initials': 'D', 'LastName': 'Sarbapalli', 'Affiliation': ''}, {'ForeName': 'Ranabir', 'Initials': 'R', 'LastName': 'Pal', 'Affiliation': ''}, {'ForeName': 'Ujjal', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': ''}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': ''}, {'ForeName': 'Kanak Kanti', 'Initials': 'KK', 'LastName': 'Kundu', 'Affiliation': ''}, {'ForeName': 'Forhad Akhtar', 'Initials': 'FA', 'LastName': 'Zaman', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.76508']
2231,21655008,A comparative study of efficacy of esmolol and fentanyl for pressure attenuation during laryngoscopy and endotracheal intubation.,"OBJECTIVE
To compare the effectiveness of single bolus dose of esmolol or fentanyl in attenuating the hemodynamic responses during laryngoscopy and endotracheal intubation.
METHODS
Ninety adult ASA I and ASA II patients were included in the study who underwent elective surgical procedures. Patients were divided into three groups. Group C (control) receiving 10 ml normal saline, group E (esmolol) receiving bolus dose of esmolol 2 mg/kg and group F (fentanyl) receiving bolus dose of fentanyl 2 µg/kg intravenously slowly. Study drug was injected 3 min before induction of anesthesia. Heart rate, systemic arterial pressure and ECG were recorded as baseline and after administration of study drug at intubation and 15 min thereafter.
RESULTS
Reading of heart rate, blood pressure and rate pressure product were compared with baseline and among each group. The rise in heart rate was minimal in esmolol group and was highly significant. Also the rate pressure product at the time of intubation was minimal and was statistically significant rate 15 min thereafter in group E.
CONCLUSION
Esmolol 2 mg/kg as a bolus done proved to be effective in attenuating rises in heart rate following laryngoscopy and intubation while the rise in blood pressure was suppressed but not abolished by bolus dose of esmolol.",2011,"Also the rate pressure product at the time of intubation was minimal and was statistically significant rate 15 min thereafter in group E.
CONCLUSION
Esmolol 2 mg/kg as a bolus done proved to be effective in attenuating rises in heart rate following laryngoscopy and intubation while the rise in blood pressure was suppressed but not abolished by bolus dose of esmolol.",['Ninety adult ASA I and ASA II patients were included in the study who underwent elective surgical procedures'],"['esmolol', 'Esmolol', 'Group C (control) receiving 10 ml normal saline, group E (esmolol) receiving bolus dose of esmolol 2 mg/kg and group F (fentanyl) receiving bolus dose of fentanyl 2 µg/kg intravenously slowly', 'esmolol or fentanyl', 'esmolol and fentanyl']","['Reading of heart rate, blood pressure and rate pressure product', 'heart rate', 'Heart rate, systemic arterial pressure and ECG', 'rate pressure product', 'hemodynamic responses', 'blood pressure']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441839', 'cui_str': 'Group E (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0441840', 'cui_str': 'Group F (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",90.0,0.106324,"Also the rate pressure product at the time of intubation was minimal and was statistically significant rate 15 min thereafter in group E.
CONCLUSION
Esmolol 2 mg/kg as a bolus done proved to be effective in attenuating rises in heart rate following laryngoscopy and intubation while the rise in blood pressure was suppressed but not abolished by bolus dose of esmolol.","[{'ForeName': 'Shobhana', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology, Medical College, Jamnagar, Gujarat, India.'}, {'ForeName': 'Purvi', 'Initials': 'P', 'LastName': 'Tank', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.76473']
2232,21655011,Palonosetron: A novel approach to control postoperative nausea and vomiting in day care surgery.,"BACKGROUND
Postoperative nausea and vomiting (PONV) is one of the complications which hamper the successful implementation of day care surgical procedure in spite of the availability of so many antiemetic drugs and regimens for its prevention. The aim was to compare the prophylactic effects of intravenously (IV) administered ondansetron and palonosetron on PONV prevention in patients undergoing laparoscopic gynecological surgery under general anesthesia.
METHODS
A prospective double-blind study comprised of 60 ASAI/II female patients between the age group of 25 and 40 years was carried out in the Departments of Anesthesiology and Obstetrics and Gynecology of our institute. Patients were randomly divided into two groups of 30 patients each in a double-blind manner. Group I received 8 mg of inj. ondansetron IV while group II received inj. palonosetron 0.075 mg IV 5 minutes before the induction of anesthesia. The need for rescue antiemetics, episodes of PONV and other side effects were observed for 6 hours in the postanesthesia care unit and thereafter complaints were received on phone after the discharge. At the end of study, results were compiled and statistical data was subjected to statistical analysis using Student two-tailed 't' and χ(2) test and value of P<0.05 was considered significant.
RESULTS
The demographical profile of the patients was comparable. Twenty and 13.33% of the patients in group I had nausea and vomiting episodes postoperatively as compared to 6.67% and 3.33%, respectively, in group II which was statistically significant (P<0.05). Twenty percent of the patients in group I experienced significant post-op headache as compared to 6.67% in group II. The mean rescue dose of antiemetic was significantly higher (10.6 mg) in the group I as compared to group II (6.4 mg) (P=0.036). The rest of parameters were comparable and statistically nonsignificant.
CONCLUSIONS
Palonosetron is a comparatively better drug to prevent the PONV in patients undergoing day care surgical procedures as compared to ondansetron as it has got a prolonged duration of action and favorable side-effects profile.",2011,The mean rescue dose of antiemetic was significantly higher (10.6 mg) in the group I as compared to group II (6.4 mg) (P=0.036).,"['day care surgery', 'patients undergoing day care surgical procedures', 'patients undergoing laparoscopic gynecological surgery under general anesthesia', '60 ASAI/II female patients between the age group of 25 and 40 years was carried out in the Departments of Anesthesiology and Obstetrics and Gynecology of our institute']","['palonosetron', 'ondansetron', 'Palonosetron', 'ondansetron and palonosetron']","['nausea and vomiting episodes', 'mean rescue dose of antiemetic', 'significant post-op headache']","[{'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",,0.0610056,The mean rescue dose of antiemetic was significantly higher (10.6 mg) in the group I as compared to group II (6.4 mg) (P=0.036).,"[{'ForeName': 'Sukhminderjit Singh', 'Initials': 'SS', 'LastName': 'Bajwa', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Gian Sagar Medical College & Hospital, Ram Nagar, Banur, Punjab, India.'}, {'ForeName': 'Sukhwinder Kaur', 'Initials': 'SK', 'LastName': 'Bajwa', 'Affiliation': ''}, {'ForeName': 'Jasbir', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Veenita', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Amarjit', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Sps', 'Initials': 'S', 'LastName': 'Goraya', 'Affiliation': ''}, {'ForeName': 'Ss', 'Initials': 'S', 'LastName': 'Parmar', 'Affiliation': ''}, {'ForeName': 'Kamaljit', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.76484']
2233,21655013,Evaluation of analgesic effects of intrathecal clonidine along with bupivacaine in cesarean section.,"UNLABELLED
AIMS AND CONTEXT: The objective of the present study was to evaluate the analgesic and adverse effects of intrathecal clonidine with hyperbaric bupivacaine in spinal anesthesia.
SETTINGS AND DESIGN
Randomized single blind trial.
METHODS
210 ASA I-II pregnant females undergoing emergency cesarean section were randomized in a single-blind fashion to one of the three groups. In group I (n=70) patients received 12.5 mg of 0.5% hyperbaric bupivacaine intrathecally. In group II (n=70) patients received intrathecal mixture of 0.5% hyperbaric bupivacaine (8 mg) and clonidine 50 μg. In group III (n=70), patients received 0.5% hyperbaric bupivacaine (10 mg) intrathecally along with 50 μg of clonidine.
STATISTICAL ANALYSIS USED
Groups were compared using one-way ANOVA with the Bonferroni multiple comparison post hoc test. The proportion of adverse events was compared using the chi-square test (χ(2) =57.2410).
RESULTS
On adding 50 μg clonidine, we were able to reduce intrathecal dose of bupivacaine for cesarean section to 8 mg. Patients receiving intrathecal clonidine along with bupivacaine had significantly long lasting analgesia with lower bupivacaine dose [246.21±5.15 min. (group II) vs 146.0±4.55 min (group I), P=0.021; 95% confidence interval: 238.01-257.40, group II and 134.99-157.0 group I].
CONCLUSIONS
Addition of intrathecal clonidine causes some sedation in the postoperative period, but it provides adequate analgesia and motor paralysis at lower dose of bupivacaine. It also significantly prolongs postoperative pain relief.",2011,"(group II) vs 146.0±4.55 min (group I), P=0.021; 95% confidence interval: 238.01-257.40, group II and 134.99-157.0 group I].
","['210 ASA I-II pregnant females undergoing emergency cesarean section', 'cesarean section']","['hyperbaric bupivacaine', 'intrathecal clonidine', 'bupivacaine', 'clonidine', 'intrathecal mixture of 0.5% hyperbaric bupivacaine']","['postoperative pain relief', 'lasting analgesia', 'proportion of adverse events']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",210.0,0.140908,"(group II) vs 146.0±4.55 min (group I), P=0.021; 95% confidence interval: 238.01-257.40, group II and 134.99-157.0 group I].
","[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Kothari', 'Affiliation': 'Department of Anesthesiology, CSMMU (erstwhile KGMC), Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Jaishri', 'Initials': 'J', 'LastName': 'Bogra', 'Affiliation': ''}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Chaudhary', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.76499']
2234,21655014,Dexmedetomidine versus propofol for sedation in patients undergoing vitreoretinal surgery under sub-Tenon's anesthesia.,"PURPOSE
The purpose of this study was to evaluate the hemodynamic, respiratory effects, the recovery profile, surgeons, and patients satisfaction with dexmedetomidine sedation compared with those of propofol sedation in patients undergoing vitreoretinal surgery under sub-Tenon's anesthesia.
METHODS
Sixty patients were enrolled in this prospective, single-blind, randomized study. The patients were divided into two groups to receive either dexmedetomidine (group D) or propofol (group P). Sedation level was titrated to a Ramsay sedation scale (RSS) of 3. Hemodynamic and respiratory effects, postoperative recovery time, analgesic effects, surgeons and patients satisfaction were assessed.
RESULTS
Both groups provided a similar significant reduction in heart rate and mean arterial pressure compared with baseline values. The respiratory rate values of the dexmedetomidine group were significantly higher than those in the propofol group. The oxygen saturation values of the dexmedetomidine group were significantly higher than those of the propofol group. The expired CO(2) was similar in both groups. Postoperatively, the time to achieve an Aldrete score of 10 was similar in both groups. Dexmedetomidine patients have significantly lower visual analog scale for pain than propofol patients. The surgeon satisfaction with patients' sedation was similar for both groups. The patients' satisfaction was higher in the dexmedetomidine group.
CONCLUSION
Dexmedetomidine at similar sedation levels with propofol was associated with equivalent hemodynamic effects, maintaining an adequate respiratory function, similar time of discharge from PACU, better analgesic properties, similar surgeon's satisfaction, and higher patient's satisfaction. Thus, dexmedetomidine may prove to be a valuable adjuvant for sedation in patients undergoing vitreoretinal surgery under sub-Tenon's anesthesia.",2011,The oxygen saturation values of the dexmedetomidine group were significantly higher than those of the propofol group.,"[""patients undergoing vitreoretinal surgery under sub-Tenon's anesthesia"", 'Sixty patients']","['Dexmedetomidine', 'dexmedetomidine sedation', 'propofol', 'propofol sedation', 'dexmedetomidine']","['heart rate and mean arterial pressure', 'visual analog scale for pain', 'respiratory rate values', 'Sedation level', 'time to achieve an Aldrete score', 'expired CO(2', 'oxygen saturation values', 'Hemodynamic and respiratory effects, postoperative recovery time, analgesic effects, surgeons and patients satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",60.0,0.0415783,The oxygen saturation values of the dexmedetomidine group were significantly higher than those of the propofol group.,"[{'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Ghali', 'Affiliation': 'Department of Anaesthesiology, Magrabi Eye & Ear Hospital, Muscat, Sultanate of Oman.'}, {'ForeName': 'Abdul Kader', 'Initials': 'AK', 'LastName': 'Mahfouz', 'Affiliation': ''}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Ihanamäki', 'Affiliation': ''}, {'ForeName': 'Ashraf M', 'Initials': 'AM', 'LastName': 'El Btarny', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.76506']
2235,21655016,Combined parecoxib and I.V. paracetamol provides additional analgesic effect with better postoperative satisfaction in patients undergoing anterior cruciate ligament reconstruction.,"BACKGROUND
Adequacy of postoperative analgesia is one of the most important factors that determine early hospital discharge and patients' ability to resume their normal activities postoperatively. The optimal non-opioid analgesic technique for postoperative pain management would reduce pain and enhance patient satisfaction, and it also facilitates earlier mobilization and rehabilitation by reducing pain-related complications after surgery. The aim of this study was to evaluate the analgesic efficacy of intravenous paracetamol and parecoxib when used alone, or in combination.
METHODS
Sixty American Society of Anesthesiology (ASA) physical status I and II adult patients who were scheduled for anterior cruciate ligament reconstruction were included in this study. Patients were allocated into three groups: group I patients received 1g intravenous paracetamol after induction and another 1 g 4 h later, group II received 40 mg parecoxib after induction, while group III received combination of both drugs (paracetamol 1 g and parecoxib 40 mg). Pain during rest and mobility was assessed in the immediate postoperative period, 2 h and 8 h successively using visual analog scale (VAS). Patient satisfaction was rated according to satisfaction score.
RESULTS
Total morphine requirements were lower in group III patients (6.9±2.7 mg) in comparison to group I patients (12.6±3.6 mg) or group II patients (9.8±2.8 mg). The least VAS scores were recorded during knee movement (3.8±1.1) in group III patients compared to group I (6.0±1.8) and group II patients (4.8±1.9). Eight hours postoperatively, group III patients were more satisfied regarding the postoperative pain management.
CONCLUSION
Combination of intravenous paracetamol and parecoxib provided better analgesia and higher patient satisfaction than each drug when used separately.",2011,"RESULTS
Total morphine requirements were lower in group III patients (6.9±2.7 mg) in comparison to group I patients (12.6±3.6 mg) or group II patients (9.8±2.8 mg).","['adult patients who were scheduled for anterior cruciate ligament reconstruction', 'Sixty American Society of Anesthesiology', 'patients undergoing anterior cruciate ligament reconstruction']","['intravenous paracetamol', 'parecoxib', 'paracetamol and parecoxib', 'paracetamol', 'combination of both drugs (paracetamol 1 g and parecoxib']","['pain and enhance patient satisfaction', 'Patient satisfaction', 'analgesic efficacy', 'visual analog scale (VAS', 'least VAS scores', 'Pain during rest and mobility', 'Total morphine requirements', 'ASA) physical status', 'postoperative pain management', 'analgesia and higher patient satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",60.0,0.0306938,"RESULTS
Total morphine requirements were lower in group III patients (6.9±2.7 mg) in comparison to group I patients (12.6±3.6 mg) or group II patients (9.8±2.8 mg).","[{'ForeName': 'Zeinab Ahmed', 'Initials': 'ZA', 'LastName': 'Elseify', 'Affiliation': 'AL-Ahli Hospital, Doha, Qatar.'}, {'ForeName': 'Salwa Omar', 'Initials': 'SO', 'LastName': 'El-Khattab', 'Affiliation': ''}, {'ForeName': 'Ahmed Metwally', 'Initials': 'AM', 'LastName': 'Khattab', 'Affiliation': ''}, {'ForeName': 'Eman Mohammed', 'Initials': 'EM', 'LastName': 'Atta', 'Affiliation': ''}, {'ForeName': 'Layal Fares', 'Initials': 'LF', 'LastName': 'Ajjoub', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.76510']
2236,21655017,"Comparative study of attenuation of the pain caused by propofol intravenous injection, by granisetron, magnesium sulfate and nitroglycerine.","BACKGROUND
Propofol has the disadvantage of causing pain or discomfort on injection. The aim of the study was to assess the efficacy of pretreatment with various drugs to alleviate the propofol injection pain.
METHODS
One hundred American Society of Anesthesiology (ASA) I and II adults, scheduled for various elective surgical procedures under general anesthesia (GA), were included in the study. They were randomly divided into four groups having 25 patients in each group. Group A received pretreatment with intravenous (i.v.) magnesium sulfate, group B received i.v. granisetron, group C received i.v. nitroglycerine and group D was the control group. One-fourth of the total calculated induction dose of propofol was administered over a period of 5 seconds. The patients were asked about the pain on injection. The intensity of pain was assessed using verbal response. A score of 0-3 which corresponds to no, mild, moderate and severe pain was recorded.
RESULTS
All the three drugs reduced the incidence and intensity of pain on propofol injection but the order of efficacy in attenuation of pain on the propofol injection was granisetron > nitroglycerine > magnesium sulfate > control.
CONCLUSION
Granisetron was the most effective followed by nitroglycerine and magnesium sulfate in attenuating pain on propofol intravenous injection.",2011,Granisetron was the most effective followed by nitroglycerine and magnesium sulfate in attenuating pain on propofol intravenous injection.,"['One hundred American Society of Anesthesiology (ASA', 'I and II adults, scheduled for various elective surgical procedures under general anesthesia (GA']","['Propofol', 'granisetron, magnesium sulfate and nitroglycerine', 'intravenous (i.v.) magnesium sulfate', 'Granisetron', 'nitroglycerine and magnesium sulfate', 'propofol', 'nitroglycerine', 'granisetron']","['intensity of pain', 'incidence and intensity of pain', 'severe pain']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",100.0,0.0387152,Granisetron was the most effective followed by nitroglycerine and magnesium sulfate in attenuating pain on propofol intravenous injection.,"[{'ForeName': 'Dhananjay Kumar', 'Initials': 'DK', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, Pain Management & ICU, Himalayan Institute of Medical Sciences, Jolly Grant, Dehradun, India.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Jindal', 'Affiliation': ''}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.76511']
2237,21655018,Effect of magnesium infusion on thoracic epidural analgesia.,"INTRODUCTION
Patients of lung volume reduction surgery (LVRS) having an ASA status III or more are likely to be further downgraded by surgery to critical levels of pulmonary function.
AIM
To compare the efficacy of thoracic epidural block with (0.125%) bupivacaine, fentanyl combination and (0.125%) bupivacaine, fentanyl combination with adjunctive intravenous magnesium infusion for the relief of postoperative pain in patients undergoing LVRS.
METHODS
Patients were operated under general anesthesia. Thirty minutes before the anticipated completion of skin closure in both groups, (Group A and Group B) 7 ml of (0.125%) bupivacaine calculated as 1.5 ml/thoracic segment space for achieving analgesia in dermatomes of T4, T5, T6, T7, and T8 segments, along with fentanyl 50 μg (0.5 ml), was administered through the catheter, activating the epidural block, and the time was noted. Thereafter, in patients of Group A, magnesium sulfate injection 30 mg/kg i.v. bolus was followed by infusion of magnesium sulfate at 10 mg/kg/hr and continued up to 24 hours. Group B was treated as control.
RESULTS AND ANALYSIS
A significant increase in the mean and maximum duration of analgesia in Group A in comparison with Group B (P<0.05) was observed. Total epidural dose of fentanyl and bupivacaine required in Group A was significantly lower in comparison with Group B in 24 hours.
DISCUSSION
Requirement of total doses of local anesthetics along with opioids could be minimized by magnesium infusion; therefore, the further downgradation of patients of LVRS may be prevented.
CONCLUSION
Intravenous magnesium can prolong opioid-induced analgesia while minimizing nausea, pruritus, and somnolence.",2011,"Total epidural dose of fentanyl and bupivacaine required in Group A was significantly lower in comparison with Group B in 24 hours.
","['Patients were operated under general anesthesia', 'patients undergoing LVRS']","['lung volume reduction surgery (LVRS', 'magnesium sulfate', 'bupivacaine', 'magnesium infusion', 'bupivacaine, fentanyl combination and (0.125%) bupivacaine, fentanyl combination with adjunctive intravenous magnesium infusion', 'fentanyl and bupivacaine', 'magnesium', 'magnesium sulfate injection']","['thoracic epidural analgesia', 'mean and maximum duration of analgesia', 'postoperative pain', 'nausea, pruritus, and somnolence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0375931', 'cui_str': 'Lung volume reduction surgery'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4034135', 'cui_str': 'Magnesium Sulfate Injection'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}]",,0.0616778,"Total epidural dose of fentanyl and bupivacaine required in Group A was significantly lower in comparison with Group B in 24 hours.
","[{'ForeName': 'Sampa Dutta', 'Initials': 'SD', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology & Chest Medicine, Institute of Postgraduate Medical Education and Research /SSKM Hospital, Bose Road, Kolkata, India.'}, {'ForeName': 'Koel', 'Initials': 'K', 'LastName': 'Mitra', 'Affiliation': ''}, {'ForeName': 'Maitreyee', 'Initials': 'M', 'LastName': 'Mukherjee', 'Affiliation': ''}, {'ForeName': 'Suddhadeb', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'Aniruddha', 'Initials': 'A', 'LastName': 'Sarkar', 'Affiliation': ''}, {'ForeName': 'Sudeshna', 'Initials': 'S', 'LastName': 'Kundu', 'Affiliation': ''}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Goswami', 'Affiliation': ''}, {'ForeName': 'Uday Narayan', 'Initials': 'UN', 'LastName': 'Sarkar', 'Affiliation': ''}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Sanki', 'Affiliation': ''}, {'ForeName': 'Ritabrata', 'Initials': 'R', 'LastName': 'Mitra', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.76512']
2238,21655019,"A clinical comparison of etomidate-lipuro, propofol and admixture at induction.","OBJECTIVE
The purpose of this study was to compare etomidate-lipuro and propofol and 50%, (1:1) admixture of these agents at induction with special reference to injection pain, hemodynamic changes, and myoclonus.
METHODS
Ninety patients were assigned at random to three groups in which induction was performed with either etomidate-lipuro, propofol or etomidate-lipuro-propofol admixture. After monitorization with bispectral index (BIS) all agents were given with infusion with a perfuser at a constant rate of 200 ml/min till the BIS values decreased to 40. Blood pressure and heart rate were measured every 30 s at this period. Patients were asked for pain at the injection site and observed visually for myoclonus. The time BIS values decreased to 40 (BIS 40 time) and total amounts of induction doses were measured.
RESULTS
BIS 40 time measurements were P > E > PE (199.4 ± 40.9, 176.9 ± 31.6, 163.5 ± 20.6 s). The hemodynamic (systolic, diastolic and mean blood pressures, heart rate) changes were minimal in group PE than other two groups (P = 0.017). The intensity of myoclonus was graded as mild in 9, moderate in 12, and severe in 5 patients in the group E (76.3%). Myoclonus was not observed in group PE and group P. There were no injection pain in group PE as the incidence were (83.8%) in group P and in (63.2%) group E.
CONCLUSION
Incidence of hemodynamic changes, myoclonus, and injection pain is significantly lower in group PE. BIS 40 times is least in group PE. We concluded that 1:1 admixture of etomidate-lipuro and propofol is a valuable agent for induction.",2011,"The hemodynamic (systolic, diastolic and mean blood pressures, heart rate) changes were minimal in group PE than other two groups (P = 0.017).",['Ninety patients'],"['etomidate-lipuro, propofol or etomidate-lipuro-propofol admixture', 'etomidate-lipuro and propofol', 'etomidate-lipuro, propofol and admixture at induction']","['time BIS values', 'Blood pressure and heart rate', 'intensity of myoclonus', 'injection pain', 'hemodynamic changes, myoclonus, and injection pain', 'hemodynamic (systolic, diastolic and mean blood pressures, heart rate) changes', 'Myoclonus']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0027066', 'cui_str': 'Myoclonic Jerk'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",90.0,0.0430165,"The hemodynamic (systolic, diastolic and mean blood pressures, heart rate) changes were minimal in group PE than other two groups (P = 0.017).","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Saricaoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ankara, Turkey.'}, {'ForeName': 'Sennur', 'Initials': 'S', 'LastName': 'Uzun', 'Affiliation': ''}, {'ForeName': 'Oguzhan', 'Initials': 'O', 'LastName': 'Arun', 'Affiliation': ''}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Arun', 'Affiliation': ''}, {'ForeName': 'Ulku', 'Initials': 'U', 'LastName': 'Aypar', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.76509']
2239,31302767,Oral cryotherapy for oral mucositis management in patients receiving allogeneic hematopoietic stem cell transplantation: a prospective randomized study.,"PURPOSE
To explore the best schedule of oral cryotherapy for the prevention of oral mucositis in recipients of myeloablative hematopoietic stem cell transplantation (HSCT).
METHODS
A prospective randomized study was conducted to recruit allogeneic HSCT recipients, who were then randomly allocated into four arms to accept the following: oral cryotherapy during the whole course (arm A) or second half of the course (arm B) of cytotoxic agents administration, regular oral cryotherapy twice a day (arm C), or conventional oral care without cryotherapy (arm D). Status of oral mucositis was daily assessed from the first day of conditioning to the 15th day post-HSCT. A myeloablative conditioning regimen was used which was composed of busulfan, cyclophosphamide, and cytarabine.
RESULTS
Totally 160 cases were consecutively enrolled in this study, and 145 cases were eligible for oral mucositis assessment. Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678). The highest incidence of severe mucositis was observed in arm C. Recovery of mucositis also had a significant diversity among the 4 arms (F = 4.133, p = 0.008).
CONCLUSIONS
Risk and outcome of severe oral mucositis could be ameliorated by oral cryotherapy during the administration of cytotoxic agents for allogeneic HSCT patients receiving non-radiation myeloablative conditioning regimen, and a half-course schedule could acquire a comparable efficacy compared with the whole-course schedule.",2020,"Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678).","['allogeneic HSCT patients receiving non-radiation myeloablative conditioning regimen', 'recruit allogeneic HSCT recipients', 'recipients of myeloablative hematopoietic stem cell transplantation (HSCT', 'Totally 160 cases were consecutively enrolled in this study, and 145 cases were eligible for oral mucositis assessment', 'patients receiving allogeneic hematopoietic stem cell transplantation']","['oral cryotherapy', 'Oral cryotherapy', 'busulfan, cyclophosphamide, and cytarabine', 'cytotoxic agents administration, regular oral cryotherapy twice a day (arm C), or conventional oral care without cryotherapy (arm D']","['Status of oral mucositis', 'severe mucositis', 'lower incidence and short duration of severe mucositis', 'mucositis', 'severe oral mucositis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}]",160.0,0.0126175,"Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678).","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Xiaming', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Pingfang', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Shizhen', 'Initials': 'S', 'LastName': 'Teng', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Depei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China.""}, {'ForeName': 'Haifang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Nursing, The First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, 215006, Jiangsu Province, People's Republic of China. nswanghaifang@sina.com.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04966-z']
2240,32493213,Comparison of gastric insufflation using LMA-supreme and I-gel versus tracheal intubation in laparoscopic gynecological surgery by ultrasound: a randomized observational trial.,"BACKGROUND
The application of bedside ultrasound to evaluate gastric content and volume can assist in determining aspiration risk. Applying positive pressure ventilation via supraglottic airway devices (SAD) can result in a degree of gastric insufflation. This study assessed and compared the antral cross-sectional area (CSA) in patients undergoing laparoscopic gynecological surgery when managed with different SAD.
METHODS
One hundred American Society of Anesthesiologists I or II female patients were assessed for inclusion in this study and divided into three groups of different ventilation devices. Patients were randomly allocated into three groups to receive LMA-Supreme (Group S), I-gel (Group I) or tracheal tube (Group T). The primary outcome was the antral cross-sectional area and secondary outcomes included haemodynamic parameters and postoperative morbidity such as sore throat, hoarseness, dry throat, nausea and vomiting.
RESULTS
The antral CSA was not significantly different among three groups before induction (P = 0.451), after induction (P = 0.456) and at the end of surgery (P = 0.195). The haemodynamic variables were significantly higher in the tracheal tube group than in the LMA-Supreme and I-gel groups after insertion (P < 0.0001) and after removal (P < 0.01). Sore throat was detected in none in the I-gel group compare to two patients (6.7%) in the LMA-Supreme group and fifteen patients (50%) in the tracheal tube group. Hoareness was detected in one (3.3%) in the I-gel group compare to two patients (6.7%) in the LMA-Supreme group and eleven patients (36.7%) in the tracheal tube group.
CONCLUSIONS
The SADs do not cause obvious gastric insufflation. Thus, LMA-Supreme and I-gel can be widely used as alternative to endotracheal intubation for the short laparoscopic gynecological surgery.
TRIAL REGISTRATION
This trial was registered at the Chinese Clinical Trial Registry (ChiCTR1800018212, data of registration, September 2018).",2020,The haemodynamic variables were significantly higher in the tracheal tube group than in the LMA-Supreme and I-gel groups after insertion (P < 0.0001) and after removal (P < 0.01).,"['One hundred American Society of Anesthesiologists', 'laparoscopic gynecological surgery by ultrasound', 'I or II female patients', 'patients undergoing laparoscopic gynecological surgery when managed with different SAD']","['LMA-Supreme (Group S), I-gel (Group I) or tracheal tube', 'positive pressure ventilation via supraglottic airway devices (SAD', 'LMA-supreme and I-gel versus tracheal intubation']","['antral cross-sectional area and secondary outcomes included haemodynamic parameters and postoperative morbidity such as sore throat, hoarseness, dry throat, nausea and vomiting', 'haemodynamic variables', 'Hoareness', 'Sore throat', 'antral CSA']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0235234', 'cui_str': 'Pharyngeal dryness'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",100.0,0.131033,The haemodynamic variables were significantly higher in the tracheal tube group than in the LMA-Supreme and I-gel groups after insertion (P < 0.0001) and after removal (P < 0.01).,"[{'ForeName': 'Qiuping', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China.""}, {'ForeName': 'Gordon Tin Chun', 'Initials': 'GTC', 'LastName': 'Wong', 'Affiliation': ""Department of Anesthesiology, The University of Hong Kong, Hong Kong SAR, People's Republic of China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China. luyao-mz@163.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01057-z']
2241,21189855,Superficial extraconal blockade for vitreoretinal surgery.,"CONTEXT
Needle length plays an important role for the success of ophthalmic block. The standard practice is to use 25 mm needles length; however, unnecessarily long needles may increase the risk of complications especially in the presence of staphyloma or previous scleral buckle.
AIMS
This work was designed to compare the efficacy of using 15 and 25 mm needle in performing extraconal block for patients undergoing vitreoretinal surgery.
SETTINGS AND DESIGN
Prospective randomized double blinded study.
MATERIALS AND METHODS
A total of 120 patients were enrolled in this study and were divided in two groups. In group (1) extraconal block was performed using 25 mm needle, while in group (2) 15 mm needle was used. After primary injection, assessment of the block was done by an anesthesiologist who was unaware of the needle used. If satisfactory akinesia was not achieved a supplementation was provided. At the end of the procedures, patients and surgeons were asked to assess their pain and satisfaction with the anesthetic technique.
STATISTICAL ANALYSIS USED
The sample size calculation using N-Quary version 4. Numerical and categorical data were analyzed using an independent sample, a two-tailed t-test, and chi-square test, respectively.
RESULTS
The volume of primary injectable was significantly higher in group 2. The two groups were comparable as regards total volume of local anesthetic, supplementation rate, akinesia, pain score, and surgeon satisfaction.
CONCLUSIONS
Using 15 mm needle length to perform extraconal blockade for posterior segment procedures is equally effective to 25 mm needle.",2010,"The two groups were comparable as regards total volume of local anesthetic, supplementation rate, akinesia, pain score, and surgeon satisfaction.
","['patients undergoing vitreoretinal surgery', 'vitreoretinal surgery', 'A total of 120 patients were enrolled in this study and were divided in two groups']",['Superficial extraconal blockade'],"['total volume of local anesthetic, supplementation rate, akinesia, pain score, and surgeon satisfaction', 'pain and satisfaction', 'volume of primary injectable']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0085623', 'cui_str': 'Akinesia (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]",120.0,0.0595112,"The two groups were comparable as regards total volume of local anesthetic, supplementation rate, akinesia, pain score, and surgeon satisfaction.
","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Riad', 'Affiliation': 'Department of Anesthesiology King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Abboud', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Al-Harthi', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kahtani', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.71346']
2242,21189856,Comparison of efficacy of bupivacaine and fentanyl with bupivacaine and sufentanil for epidural labor analgesia.,"OBJECTIVES
A study to compare the efficacy between fentanyl and sufentanil combined with low concentration (0.0625%) of bupivacaine for epidural labor analgesia in laboring women
MATERIALS AND METHODS
Fifty full term parturients received an initial bolus dose of a 10 ml solution containing 0.125% bupivacaine. The patients were randomly divided into two: group F received 0.0625% bupivacaine with 2.5 mcg/ml fentanyl and group S received 0.0625% bupivacaine with 0.25 mcg/ml sufentanil. Verbal analogue pain scores, need of supplementary/rescue boluses dose of bupivacaine consumed, mode of delivery, maternal satisfaction, and neonatal Apgar scores were recorded. No significant difference was observed between both groups.
RESULTS
Both the groups provided equivalent labor analgesia and maternal satisfaction. The chances of cesarean delivery were also not increased in any group. No difference in the cephalad extent of sensory analgesia, motor block or neonatal Apgar score were observed. Although mean pain scores throughout the labor and delivery were similar in both groups, more patients in fentanyl group required supplementary boluses though not statistically significant.
CONCLUSION
We conclude that both 0.0625% bupivacaine-fentanyl (2.5 μg/ml) and 0.0625% bupivacaine-sufentanil (0.25 μg/ml) were equally effective by continuous epidural infusion in providing labor analgesia with hemodynamic stability achieving equivalent maternal satisfaction without serious maternal or fetal side effects. We found that sufentanil was 10 times more potent than fentanyl as an analgesic for continuous epidural labor analgesia.",2010,We found that sufentanil was 10 times more potent than fentanyl as an analgesic for continuous epidural labor analgesia.,"['Fifty full term parturients', 'epidural labor analgesia', 'laboring women']","['bupivacaine with 2.5 mcg/ml fentanyl and group S received 0.0625% bupivacaine with 0.25 mcg/ml sufentanil', 'bupivacaine', 'bupivacaine and fentanyl', 'fentanyl', 'fentanyl and sufentanil', 'bupivacaine and sufentanil', 'bupivacaine-sufentanil', 'sufentanil', '10 ml solution containing 0.125% bupivacaine', 'bupivacaine-fentanyl']","['equivalent labor analgesia and maternal satisfaction', 'mode of delivery, maternal satisfaction, and neonatal Apgar scores', 'mean pain scores', 'cephalad extent of sensory analgesia, motor block or neonatal Apgar score', 'Verbal analogue pain scores', 'chances of cesarean delivery']","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}]","[{'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205096', 'cui_str': 'Cephalic (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}]",50.0,0.0868874,We found that sufentanil was 10 times more potent than fentanyl as an analgesic for continuous epidural labor analgesia.,"[{'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Kalra', 'Affiliation': 'Department of Anaesthesia, Lady Hardinge Medical College, New Delhi, India.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Saraswat', 'Affiliation': ''}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Agnihotri', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.71569']
2243,21189846,Evaluation of the surgical factor in postoperative pain control.,"BACKGROUND
Postoperative pain control has been studied extensively, including many perioperative pain control procedures. Unfortunately, the impact of the surgical technique was not objectively studied.
AIM
The aim of this study is to evaluate if the type of surgical dissection needed for extensive abdominal wall dissection actually has an effect in the reduction of postoperative pain or not.
MATERIALS AND METHODS
Forty adult patients, 19 males and 21 females, were randomly divided into two groups with each group containing 20 patients having different varieties of anterior abdominal wall ventral hernia. Patients in group I had their hernias and abdominal wall flaps dissected by only sharp dissection using scalpel. Patients in group II had their hernias and abdominal wall flaps dissected using mainly blunt dissection assisted by sharp dissection where blunt dissection could not do the job. All the patients had general anesthesia. No preemptive analgesia was used. Nalbufen was used as the only postoperative pain killer and the total amount used of it was treated as the indicator for the intensity of postoperative pain.
RESULTS
The results of the present study showed that the total amount of Nalbufen used for the control of postoperative pain is significantly less in group I throughout the postoperative follow-up period.
CONCLUSION
This study concludes that use of sharp dissection in cases of extensive abdominal wall dissection is statistically better than other methods of dissection in terms of postoperative pain control.",2010,This study concludes that use of sharp dissection in cases of extensive abdominal wall dissection is statistically better than other methods of dissection in terms of postoperative pain control.,"['20 patients having different varieties of anterior abdominal wall ventral hernia', 'patients had general anesthesia', 'Forty adult patients, 19 males and 21 females']",[],['postoperative pain'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0230193', 'cui_str': 'Anterior abdominal wall structure'}, {'cui': 'C0019326', 'cui_str': 'Ventral Hernia'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",40.0,0.0291133,This study concludes that use of sharp dissection in cases of extensive abdominal wall dissection is statistically better than other methods of dissection in terms of postoperative pain control.,"[{'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Shams', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Hosam M', 'Initials': 'HM', 'LastName': 'Atef', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.71134']
2244,32130025,Angiotensin II-mediated nondipping during sleep in healthy humans: effects on baroreflex function at subsequent daytime.,"Blood pressure dipping at night is mediated by sleep-inherent, active downregulation of sympathetic vascular tone. Concomitantly, activity of the renin-angiotensin system is reduced, which might contribute to the beneficial effect of baroreflex downward resetting on daytime blood pressure homeostasis. To evaluate whether experimental nondipping mediated by angiotensin II during sleep would alter blood pressure and baroreflex function the next day in healthy humans, angiotensin-II or placebo (saline) was infused for a 7-h period at night, preventing blood pressure dipping in 11 sleeping normotensive individuals (5 males, balanced, crossover design). Baroreflex function was assessed about 1 h upon awakening and stop of infusion via microneurographic recordings of muscle sympathetic nerve activity (MSNA), showing that resting MSNA was significantly increased following angiotensin II nondipping compared with placebo ( P = 0.029), whereas blood pressure and heart rate remained unchanged. Baroreflex sensitivity in response to vasoactive drug challenge was preserved, and neuroendocrine markers of fluid balance and electrolytes did not differ between conditions. Ambulatory blood pressure during subsequent daytime was not altered. Data were compared with analog experiments previously performed within the same subjects during awake daytime (ANCOVA). We conclude that angiotensin-II mediated nocturnal nondipping did not induce blood pressure elevation at subsequent daytime in healthy humans but was linked to increased vasoconstrictive sympathetic activity. This is in contrast to a prolonged increase in blood pressure in corresponding daytime experiments of the same individuals. Evidently, sleep strongly preserves normotensive blood pressure homeostasis in healthy humans.",2020,Ambulatory blood pressure during subsequent daytime was not altered.,"['healthy humans', 'eleven sleeping normotensive individuals (5 males, balanced, cross-over design']","['placebo', 'Angiotensin-II or placebo (saline', 'Angiotensin-II-mediated non-dipping', 'Angiotensin-II during sleep']","['Baroreflex sensitivity', 'Ambulatory blood pressure', 'blood pressure elevation', 'Blood pressure', 'baroreflex function', 'blood pressure and heart rate', 'blood pressure', 'blood pressure and baroreflex function', 'normotensive blood pressure homeostasis', 'Baroreflex function', 'vasoconstrictive sympathetic activity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0378785', 'cui_str': 'DIPS'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}]","[{'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",11.0,0.0295353,Ambulatory blood pressure during subsequent daytime was not altered.,"[{'ForeName': 'Friedhelm', 'Initials': 'F', 'LastName': 'Sayk', 'Affiliation': 'Department of Internal Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Twesten', 'Affiliation': 'Department of Internal Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Adametz', 'Affiliation': 'Institute of Radiology, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'Franzen', 'Affiliation': 'Department of Internal Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Vonthein', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Dodt', 'Affiliation': 'Department of Emergency Medicine, München-Bogenhausen Hospital, München, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Meusel', 'Affiliation': 'Department of Cardiology and Angiology, University Heart Center Lübeck, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00355.2019']
2245,21333193,Uterine artery occlusion for treatment of symptomatic uterine myomas.,"OBJECTIVE
To compare the effectiveness and safety of uterine artery occlusion by laparoscopy versus embolization as a treatment modality for symptomatic uterine fibroids.
METHODS
Ninety-six premenopausal women with symptomatic uterine leiomyomata were studied. None of them desired further pregnancy. They were randomized to treatment either by laparoscopic occlusion (group 1) or by radiologic embolization of uterine arteries (group 2). The primary outcome measure was patient satisfaction as regards menstrual blood loss compared with pretreatment loss. Secondary outcome measures included postoperative pain, complications, secondary interventions, and failures.
RESULTS
Ninety women were followed for 1, 3, 6, and 12 months after both procedures. The primary outcome was comparable between the 2 groups (86.7% after laparoscopic occlusion versus 88.8% after embolization, with no statistically significant difference). After 12 months of follow-up, more patients resumed heavy periods in the uterine artery occlusion group [4/45 patients, 8.8% in occlusion group compared with 3/45 (6.6%) in embolization group, P=0.044].
CONCLUSION
Both laparoscopic occlusion and superselective embolization of uterine arteries improved clinical symptoms in the majority of patients. At 12-month follow-up, embolization might be more effective.",2010,"The primary outcome was comparable between the 2 groups (86.7% after laparoscopic occlusion versus 88.8% after embolization, with no statistically significant difference).","['symptomatic uterine fibroids', 'Ninety women', 'symptomatic uterine myomas', 'Ninety-six premenopausal women with symptomatic uterine leiomyomata were studied']","['laparoscopic occlusion and superselective embolization', 'uterine artery occlusion by laparoscopy versus embolization', 'laparoscopic occlusion (group 1) or by radiologic embolization of uterine arteries', 'Uterine artery occlusion']","['patient satisfaction as regards menstrual blood loss', 'clinical symptoms', 'heavy periods', 'postoperative pain, complications, secondary interventions, and failures']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0729536', 'cui_str': 'Uterine Artery Embolization'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood (substance)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",90.0,0.256638,"The primary outcome was comparable between the 2 groups (86.7% after laparoscopic occlusion versus 88.8% after embolization, with no statistically significant difference).","[{'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Helal', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University Hospitals, Faculty of Medicine, Mansoura University, Egypt. adelsaadhelal@yahoo.com'}, {'ForeName': 'Abd El-Mageed', 'Initials': 'Ael-M', 'LastName': 'Mashaly', 'Affiliation': ''}, {'ForeName': 'Talal', 'Initials': 'T', 'LastName': 'Amer', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680810X12924466007403']
2246,21333194,"A randomized, controlled study comparing two standardized closure methods of laparoscopic port sites.","OBJECTIVES
To compare octyl-cyanoacrylate tissue adhesive (OCT) with the standard suture technique for the closure of laparoscopic port sites.
METHODS
This was a randomized clinical trial of 40 patients. All participants had 2 lower abdominal ports, with one port closed using OCT while the opposite port was closed with 4-0 monocryl suture. An evaluation of the wound was performed 2 weeks to 4 weeks after surgery. The Hollander Wound Evaluation Scale (HWES, including step-off of borders, contour irregularities, margin separation, edge inversion, excessive distortion, and overall appearance) was used for cosmetic evaluation. Complications, such as erythema, warmth, tenderness, drainage, and wound infection, were evaluated. Analysis of complications was performed using the chi-square test, and cosmetic evaluation including individual components of the HWES was compared with the t test, P<0.05 considered significant.
RESULTS
Eighty wounds were evaluated in 40 patients. The number of patients with complications including erythema (1/40 vs. 16/40), tenderness (1/40 vs. 19/40), and drainage (1/40 vs. 9/40) was lower with OCT than with sutures, respectively (all P<0.001). The ports closed with OCT had higher overall HWES, ie, better cosmetic score (5.92 ± 0.05 vs 5.50±0.13) and lower margin separation (1/40 vs. 10/40) but had higher contour irregularity (6/40 vs. 1/40) (all P=0.05). However, skin contour irregularity was significantly better when OCT was applied using fine tissue forceps (P=0.002).
CONCLUSION
Laparoscopic ports closed with OCT had fewer early complications, such as wound erythema, tenderness, and drainage. Ports closed with OCT had a better cosmetic appearance.",2010,"However, skin contour irregularity was significantly better when OCT was applied using fine tissue forceps (P=0.002).
","['Eighty wounds were evaluated in 40 patients', '40 patients']","['OCT', 'octyl-cyanoacrylate tissue adhesive (OCT) with the standard suture technique', 'laparoscopic port sites']","['number of patients with complications including erythema', 'tenderness', 'cosmetic score', 'Hollander Wound Evaluation Scale (HWES, including step-off of borders, contour irregularities, margin separation, edge inversion, excessive distortion, and overall appearance', 'Complications, such as erythema, warmth, tenderness, drainage, and wound infection', 'overall HWES', 'skin contour irregularity', 'lower margin separation', 'early complications, such as wound erythema, tenderness, and drainage', 'cosmetic appearance']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0391770', 'cui_str': '2-propenoic acid, 2-cyano-, octyl ester'}, {'cui': 'C0040277', 'cui_str': 'Tissue Adhesives'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038968', 'cui_str': 'Suture Technics'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0231627', 'cui_str': 'Step-off (finding)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0021945', 'cui_str': 'Inversion (morphologic abnormality)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0332482', 'cui_str': 'Abnormal shape'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0231243', 'cui_str': 'Early complication (finding)'}, {'cui': 'C0406833', 'cui_str': 'Wound erythema (finding)'}]",80.0,0.0772508,"However, skin contour irregularity was significantly better when OCT was applied using fine tissue forceps (P=0.002).
","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetric and Gynecology, New York Downtown Hospital, New York, New York, USA.'}, {'ForeName': 'Allan S', 'Initials': 'AS', 'LastName': 'Klapper', 'Affiliation': ''}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Voige', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Del Priore', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680810X12924466006729']
2247,21189848,Study of the effect of oral gabapentin used as preemptive analgesia to attenuate post-operative pain in patients undergoing abdominal surgery under general anesthesia.,"AIMS
To study the effect of oral gabapentin used as preemptive analgesia to attenuate post operative pain in patients undergoing abdominal surgery under general anesthesia.
MATERIALS AND METHODS
In a randomized double blind study, 60 patients were divided into two groups. Group A received 600mg gabapentin and group B oral received placebo 1 h prior to surgery. Anesthesia was induced with Propofol 2 mg/kg and Vecuronium 0.1mg/kg and maintained with 60% N(2)O in O(2) and Vecuronium 0.02 mg/kg. All cases were given Fentanyl 2µg/kg as pre medication and a repeat dose 1µg/kg at the end of the first hour. Assessment of post-operative pain was made with the visual analog score (VAS) at extubation (0 h), 2, 4, 6, 12, and 24 h post-operatively. Post-operative analgesia was provided with intravenous Tramadol. The first dose was given in the Post Anesthesia Care Unit as 2mg/kg, and repeated at 8 and 16 h. Rescue analgesia was given with Diclofenac 1.5mg/kg, slow intravenous. The number of doses of rescue analgesia in both the groups was noted.
RESULTS
The VAS scores at 0, 2, 4, 6, 12, and 24 h were 1.9 vs. 2.4 (P=0.002), 2.3 vs. 3.0 (P=0.000), 3.2 vs. 3.7 (P=0.006), 2.9 vs. 4.4 (P=0.000), 3.6 vs. 4.6 (P=0.000), and 3.7 vs.4.6 (P=0.000), respectively. Numbers of patients requiring rescue analgesia with Diclofenac were 3 vs. 14 (P=0.004).
CONCLUSION
A single oral dose of gabapentin given pre-operatively enhanced the analgesic effect of Tramadol as it also reduced the requirement of rescue analgesia with Diclofenac.",2010,"Numbers of patients requiring rescue analgesia with Diclofenac were 3 vs. 14 (P=0.004).
","['60 patients', 'patients undergoing abdominal surgery under general anesthesia']","['Diclofenac 1.5mg/kg, slow intravenous', 'oral gabapentin', 'gabapentin', 'placebo', 'Propofol', 'Vecuronium', 'Diclofenac', 'Tramadol']","['VAS scores', 'number of doses of rescue analgesia', 'visual analog score (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0242531', 'cui_str': 'Vecuronium'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",60.0,0.154183,"Numbers of patients requiring rescue analgesia with Diclofenac were 3 vs. 14 (P=0.004).
","[{'ForeName': 'Harshel G', 'Initials': 'HG', 'LastName': 'Parikh', 'Affiliation': 'Department of Anesthesia & Critical Care, Grant Medical College & Sir J.J. Group of Hospitals, Mumbai-08, India.'}, {'ForeName': 'Sananta Kumar', 'Initials': 'SK', 'LastName': 'Dash', 'Affiliation': ''}, {'ForeName': 'Chitra B', 'Initials': 'CB', 'LastName': 'Upasani', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.71409']
2248,21189850,Combined use of remifentanil and propofol to limit patient movement during retinal detachment surgery under local anesthesia.,"BACKGROUND
One of the drawbacks of performing ophthalmic surgery under local anesthesia is patient movement, which might affect optimal surgical outcome.
PURPOSE
The study aims to evaluate the efficacy of the combined use of propofol and remifentanil as a sedative technique in comparison with the use of propofol alone to limit patient discomfort and movement during local anesthesia for vitreo-retinal surgery lasting for more than two hours.
MATERIALS AND METHODS
A total of 140 patients scheduled for vitreo-retinal surgery under local anesthesia, with an expected surgical time of more than two hours, were included in the study. Patients were divided randomly into two equal groups: group I where patients were given propofol and remifentanil by continuous infusion and group II where patients were given propofol alone by continuous infusion.
RESULTS
The two groups were comparable with regard to age, weight, gender, ASA physical status and duration of surgery. There was a significant decrease in heart rate and mean arterial blood pressure (MABP) in each group 10 minutes after the start of sedation compared with pre-sedation data and continued all through the procedure. There was an insignificant difference between the two groups with regard to changes in heart rate and MABP all through surgical procedure. There was no significant difference between the two groups with regard to the incidence of complications except for an increased incidence of breakthrough pain and discomfort which necessitated the use of fentanyl as a rescue treatment in the propofol group P<0.001. There were no instances of movements with a major effect on the surgical field, which could have affected surgical outcome, in the two groups. The number of patients who did not move was significantly higher, 56 (80%), in group I compared with 38 (54.29%) in group II with P<0.001. The ophthalmologist satisfaction scale was significantly higher in group I (4.5±0.63) compared with group II (3.7±1.04) with P=0.0016.
CONCLUSION
The combined use of propofol and remifentanil as a continuous infusion before performance of the block and during lengthy vitreo-retinal surgery was associated with a lower incidence of patient discomfort, breakthrough pain, and patient movement along with high degree of surgeons' satisfaction and hemodynamic stability.",2010,There was an insignificant difference between the two groups with regard to changes in heart rate and MABP all through surgical procedure.,"['retinal detachment surgery under local anesthesia', '140 patients scheduled for vitreo-retinal surgery under local anesthesia, with an expected surgical time of more than two hours, were included in the study', 'alone to limit patient discomfort and movement during local anesthesia for vitreo-retinal surgery lasting for more than two hours']","['propofol', 'propofol and remifentanil', 'remifentanil and propofol', 'propofol alone by continuous infusion']","['ophthalmologist satisfaction scale', 'heart rate and mean arterial blood pressure (MABP', 'breakthrough pain and discomfort', 'heart rate and MABP']","[{'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1720483', 'cui_str': 'Vitreoretinal surgery specialty'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}]","[{'cui': 'C1704292', 'cui_str': 'Ophthalmologists'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0222045'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",140.0,0.0342525,There was an insignificant difference between the two groups with regard to changes in heart rate and MABP all through surgical procedure.,"[{'ForeName': 'Abdul Kader M', 'Initials': 'AK', 'LastName': 'Mahfouz', 'Affiliation': 'Department of Anaesthesia, Alexandria University Egypt.'}, {'ForeName': 'Ashraf M', 'Initials': 'AM', 'LastName': 'Ghali', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.71570']
2249,21189853,"Comparison of esmolol and labetalol, in low doses, for attenuation of sympathomimetic response to laryngoscopy and intubation.","OBJECTIVE
The present study compared the efficacy of esmolol and labetalol, in low doses, for attenuation of sympathomimetic response to laryngoscopy and intubation.
DESIGN
Prospective, randomized, placebo controlled, double-blinded study.
SETTING
Operation room.
PATIENTS AND METHODS
75 ASA physical status I and II adult patients, aged 18-45 years undergoing elective surgical procedures, requiring general anesthesia and orotracheal intubation.
INTERVENTIONS
Patients were allocated to any of the three groups (25 each)-Group C (control)10 ml 0.9% saline i.v. Group E (esmolol) 0.5 mg/kg diluted with 0.9% saline to 10 ml i.v. Group L (labetalol) 0.25 mg/kg diluted with 0.9% saline to 10 ml i.v. In the control group 10 ml of 0.9% saline was given both at 2 and 5 min prior to intubation. In the esmolol group 0.5 mg/kg of esmolol (diluted with 0.9% saline to 10 ml) was given 2 min prior and 10 ml of 0.9% saline 5 min prior to intubation. In the labetalol group 10 ml of 0.9% saline was administered 2 min prior and 0.25 mg/kg of labetalol (diluted with 0.9% saline to 10 ml) 5 min prior to intubation. All the patients were subjected to the same standard anesthetic technique.
MEASUREMENTS
Heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded prior to induction, at time of intubation and 1, 3, 5, and 10 min after intubation. Mean arterial pressure (MAP) and rate pressure product (RPP) were calculated. Abnormal ECG changes were also recorded.
RESULTS
Compared to placebo and esmolol (0.5 mg/kg), labetalol (0.25 mg/kg) significantly attenuated the rise in heart rate, systolic blood pressure, and RPP during laryngoscopy and intubation. However, the difference was not statistically significant among the values for DBP and MAP.
CONCLUSION
In lower doses, labetalol (0.25 mg/kg) is a better agent than esmolol (0.5 mg/kg) in attenuating the sympathomimetic response to laryngoscopy and intubation.",2010,"However, the difference was not statistically significant among the values for DBP and MAP.
","['I and II adult patients, aged 18-45 years undergoing elective surgical procedures, requiring general anesthesia and orotracheal intubation', 'Operation room', '75 ASA physical status']","['esmolol', 'Group L (labetalol) 0.25 mg/kg diluted with 0.9% saline', 'placebo', 'placebo and esmolol', 'esmolol and labetalol', 'labetalol', 'Group E (esmolol) 0.5 mg/kg diluted with 0.9% saline', 'esmolol (diluted with 0.9% saline to 10 ml) was given 2 min prior and 10 ml of 0.9% saline 5 min prior to intubation', 'labetalol (diluted with 0.9% saline to 10 ml) 5 min prior to intubation', 'each)-Group C (control)10 ml 0.9% saline i.v']","['Abnormal ECG changes', 'Heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP', 'Mean arterial pressure (MAP) and rate pressure product (RPP', 'heart rate, systolic blood pressure, and RPP during laryngoscopy and intubation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0441846', 'cui_str': 'Group L (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0441839', 'cui_str': 'Group E (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}]","[{'cui': 'C0522055', 'cui_str': 'Electrocardiogram abnormal'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",75.0,0.235849,"However, the difference was not statistically significant among the values for DBP and MAP.
","[{'ForeName': 'Sarvesh P', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia, J N Medical College, Aligarh, India.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Quadir', 'Affiliation': ''}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Malhotra', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.71573']
2250,21189854,Assessment of role of perioperative melatonin in prevention and treatment of postoperative delirium after hip arthroplasty under spinal anesthesia in the elderly.,"CONTEXT
Little is known about the relationship between sedative drugs used preoperatively and postoperative delirium. Melatonin is a drug used to sedate patients preoperatively and is hypothesized by recent works to have a curative effect on postoperative delirium.
AIMS
The incidence of postoperative delirium will be tested if affected by three different sedative drugs including melatonin.
SETTINGS AND DESIGN
Controlled randomized doubleblind study.
PATIENTS AND METHODS
Three-hundred patients aged>65 years scheduled for hip arthroplasty under spinal anesthesia were randomly distributed to one of the four groups. Group 1 (control) received nothing for sedation. Group 2 (melatonin) received 5 mg melatonin. Group 3 (midazolam) received 7.5 mg midazolam. Group 4 (clonidine) received 100 μg clonidine. These medications were given orally at sleep time at night of operation and another dose 90 min before operative time. Patients who developed postoperative delirium received 5 mg of melatonin 9 pm for three successive days in a trial to treat delirium.
STATISTICAL ANALYSIS USED
Statistical analysis was done using the SPSS Software (version 13).
RESULTS
Total of 222 patients completed the study. Percentage of postoperative delirium in the control group was 32.65% (16/49 patients). The melatonin group showed a statistically significant decrease in the percentage of postoperative delirium to 9.43% (5/53 patients). Melatonin was successful in treating 58.06% of patients suffered postoperative delirium (36/62 patients) with no difference between different groups.
CONCLUSIONS
Postoperative delirium is affected with the drug used for preoperative sedation. Melatonin was successful in decreasing postoperative delirium when used preoperatively and in treating more than half of patients developed postoperative delirium when used for three postoperative nights.",2010,Melatonin was successful in decreasing postoperative delirium when used preoperatively and in treating more than half of patients developed postoperative delirium when used for three postoperative nights.,"['postoperative delirium after hip arthroplasty under spinal anesthesia in the elderly', 'Total of 222 patients completed the study', 'Three-hundred patients aged>65 years scheduled for hip arthroplasty under spinal anesthesia']","['nothing for sedation', 'Melatonin', 'midazolam', 'Group 2 (melatonin) received 5 mg melatonin', 'perioperative melatonin', 'clonidine', 'melatonin']","['postoperative delirium', 'percentage of postoperative delirium']","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}]",300.0,0.123524,Melatonin was successful in decreasing postoperative delirium when used preoperatively and in treating more than half of patients developed postoperative delirium when used for three postoperative nights.,"[{'ForeName': 'Sherif S', 'Initials': 'SS', 'LastName': 'Sultan', 'Affiliation': 'Assistant Professor of Anesthesia and Intensive Care, Faculty of Medicine, Ain Shams University, Cairo, Egypt, Consultant, Department of Anesthesia, Al-Hada Armed Forces Hospital, Taif, Kingdom of Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.71132']
2251,31537332,Cardiac Resynchronization in Women: A Substudy of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial.,"OBJECTIVES
This study sought to evaluate the effect of cardiac resynchronization therapy with defibrillator (CRT-D) as compared with implantable cardioverter-defibrillator (ICD) on mortality, heart failure (HF) hospitalization, and ventricular arrhythmia in women versus men.
BACKGROUND
CRT-D has demonstrated reduced mortality and HF hospitalizations with greater benefit observed in women compared with men. However, whether CRT-D prevented ventricular arrhythmias in women compared with men was unclear.
METHODS
The RAFT (Resynchronization-Defibrillation for Ambulatory Heart Failure Trial) study randomized 1,798 patients to an ICD or CRT-D. In this post hoc analysis, women and men were compared by randomized group. By using a multivariable model, the outcomes of death and HF hospitalization and incidence of ventricular arrhythmia were compared between men and women.
RESULTS
There were 1,490 (83%) men (732, ICD; 758, CRT-D) and 308 (17%) women (172, ICD; 136, CRT-D) included in the analysis. Women with CRT-D had a significantly reduced incidence of death and HF hospitalization compared with men with CRT-D (hazard ratio: 0.52; 95% confidence interval: 0.33 to 0.81; p < 0.001) on multivariable analysis. Women with a primary prevention indication and CRT-D had the lowest rate of ventricular arrhythmia compared with men (hazard ratio: 0.59; 95% confidence interval: 0.39 to 0.91; p = 0.016).
CONCLUSIONS
Women have improved rates of death and HF hospitalization with CRT-D and were less likely to experience ventricular arrhythmia when compared with men, after adjusting for differences in baseline characteristics over a prolonged follow-up. Whether these improved outcomes reflect inherent sex differences in the underlying myocardial substrate resulting in an enhanced response to CRT-D requires further research.",2019,Women with CRT-D had a significantly reduced incidence of death and HF hospitalization compared with men with CRT-D (hazard ratio: 0.52; 95% confidence interval: 0.33 to 0.81; p < 0.001) on multivariable analysis.,"['men and women', '1,798 patients to an ICD or CRT-D', 'Women', 'women versus men']","['Resynchronization-Defibrillation', 'RAFT (Resynchronization-Defibrillation', 'implantable cardioverter-defibrillator (ICD', 'Cardiac Resynchronization', 'cardiac resynchronization therapy with defibrillator (CRT-D', 'CRT-D']","['rates of death and HF hospitalization', 'lowest rate of ventricular arrhythmia', 'incidence of death and HF hospitalization', 'death and HF hospitalization and incidence of ventricular arrhythmia', 'mortality, heart failure (HF) hospitalization, and ventricular arrhythmia', 'mortality and HF hospitalizations', 'ventricular arrhythmias']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0336849', 'cui_str': 'Raft, device (physical object)'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",1798.0,0.317147,Women with CRT-D had a significantly reduced incidence of death and HF hospitalization compared with men with CRT-D (hazard ratio: 0.52; 95% confidence interval: 0.33 to 0.81; p < 0.001) on multivariable analysis.,"[{'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Waard', 'Affiliation': 'Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jaimie', 'Initials': 'J', 'LastName': 'Manlucu', 'Affiliation': 'London Health Sciences Center, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Gillis', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Bernick', 'Affiliation': 'Ottawa Cardiovascular Research Methods Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Doucette', 'Affiliation': 'Research Methods Unit, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'London Health Sciences Center, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'Ottawa Cardiovascular Research Methods Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada. Electronic address: ratika.parkash@nshealth.ca.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.06.007']
2252,31537689,KMT2D mutations and TP53 disruptions are poor prognostic biomarkers in mantle cell lymphoma receiving high-dose therapy: a FIL study.,"In recent years, the outcome of mantle cell lymphoma (MCL) has improved, especially in younger patients, receiving cytarabine-containing chemoimmunotherapy and autologous stem cell transplantation. Nevertheless, a proportion of MCL patients still experience early failure. To identify biomarkers anticipating failure of intensive chemotherapy in MCL, we performed target resequencing and DNA profiling of purified tumor samples collected from patients enrolled in the prospective FIL-MCL0208 phase 3 trial (high-dose chemoimmunotherapy followed by autologous transplantation and randomized lenalidomide maintenance). Mutations of KMT2D and disruption of TP53 by deletion or mutation associated with an increased risk of progression and death, both in univariate and multivariate analysis. By adding KMT2D mutations and TP53 disruption to the MIPI-c backbone, we derived a new prognostic index, the ""MIPI-genetic"" (""MIPI- g""). The ""MIPI-g"" improved the model discrimination ability compared to the MIPI-c alone, defining three risk groups: i) low-risk patients (4-year progression free survival and overall survival of 72.0% and 94.5%); ii) inter-mediate-risk patients (4-year progression free survival and overall survival of 42.2% and 65.8%) and iii) high-risk patients (4-year progression free survival and overall survival of 11.5% and 44.9%). Our results: i) confirm that TP53 disruption identifies a high-risk population characterized by poor sensitivity to conventional or intensified chemotherapy; ii) provide the pivotal evidence that patients harboring KMT2D mutations share the same poor outcome as patients harboring TP53 disruption; and iii) allow to develop a tool for the identification of high-risk MCL patients for whom novel therapeutic strategies need to be investigated. ( Trial registered at clinicaltrials.gov identifier: NCT02354313 ).",2020,"The MIPI-g improved the model discrimination ability compared to the MIPI-c alone, defining three risk groups: i) low-risk patients (4-years progression free survival and overall survival of 72.0% and 94.5%); ii) intermediate-risk patients (4-years progression free survival and overall survival of 42.2% and 65.8%) and iii) high-risk patients (4-years progression free survival and overall survival of 11.5% and 44.9%).","['mantle cell lymphoma', 'patients enrolled in the prospective FIL-MCL0208 phase III trial (high-dose chemoimmunotherapy followed by autologous transplantation and randomized lenalidomide maintenance']",['cytarabine-containing chemoimmunotherapy and autologous stem cell transplantation'],"['progression free survival and overall survival', 'risk of progression and death', 'model discrimination ability']","[{'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.034178,"The MIPI-g improved the model discrimination ability compared to the MIPI-c alone, defining three risk groups: i) low-risk patients (4-years progression free survival and overall survival of 72.0% and 94.5%); ii) intermediate-risk patients (4-years progression free survival and overall survival of 42.2% and 65.8%) and iii) high-risk patients (4-years progression free survival and overall survival of 11.5% and 44.9%).","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ferrero', 'Affiliation': 'Department of Molecular Biotechnologies and Health Sciences - Hematology Division, Università di Torino, Torino, Italy simone.ferrero@unito.it.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Rossi', 'Affiliation': 'Hematology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rinaldi', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Bruscaggin', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Spina', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Eskelund', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Evangelista', 'Affiliation': 'Clinical Epidemiology, Città della Salute e della Scienza and CPO Piemonte, Torino, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Moia', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Kwee', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dahl', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Di Rocco', 'Affiliation': 'Department of Cellular Biotechnologies and Hematology, Policlinico Umberto I, ""Sapienza"" University of Rome, Roma, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Stefoni', 'Affiliation': 'Institute of Hematology ""L. e A. Seràgnoli"", University of Bologna, Bologna, Italy.'}, {'ForeName': 'Fary', 'Initials': 'F', 'LastName': 'Diop', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Favini', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Ghione', 'Affiliation': 'Department of Molecular Biotechnologies and Health Sciences - Hematology Division, Università di Torino, Torino, Italy.'}, {'ForeName': 'Abdurraouf Mokhtar', 'Initials': 'AM', 'LastName': 'Mahmoud', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Schipani', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Kolstad', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Barbero', 'Affiliation': 'Department of Molecular Biotechnologies and Health Sciences - Hematology Division, Università di Torino, Torino, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Novero', 'Affiliation': 'First Unit of Pathology, AOU Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Paulli', 'Affiliation': 'Unit of Anatomic Pathology, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo and Università degli Studi di Pavia, Pavia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zamò', 'Affiliation': 'Department of Oncology, Università di Torino, Torino, Italy.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Jerkeman', 'Affiliation': 'Department of Oncology, Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Maria Gomes', 'Initials': 'MG', 'LastName': 'da Silva', 'Affiliation': 'Department of Hematology, Instituto Português de Oncologia de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Humanitas Cancer Center, Humanitas Clinical and Research Center, Rozzano, Italy.'}, {'ForeName': 'Annalia', 'Initials': 'A', 'LastName': 'Molinari', 'Affiliation': 'Hematology, Ospedale degli Infermi, Rimini, Italy.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Ferreri', 'Affiliation': 'Lymphoma Unit, Department of Onco-Haematology, IRCCS San Raffaele Scientific Institute, Milano, Italy.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Piccin', 'Affiliation': 'Department of Hematology, Ospedale Generale, Bolzano, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Cortelazzo', 'Affiliation': 'Oncology Unit, Humanitas/Gavazzeni Clinic, Bergamo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bertoni', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ladetto', 'Affiliation': 'SC Ematologia, Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gaidano', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}]",Haematologica,['10.3324/haematol.2018.214056']
2253,30654713,The Effect of an HIV Self-Management Intervention on Neurocognitive Behavioral Processing.,"People living with HIV (PLHIV) are increasingly diagnosed with comorbidities which require increasing self-management. We examined the effect of a self-management intervention on neurocognitive behavioral processing. Twenty-nine PLHIV completed a two-group, 3-month randomized clinical trial testing a self-management intervention to improve physical activity and dietary intake. At baseline and 3 months later, everyone completed validated assessments of physical, diet, and neurocognitive processing (functional magnetic resonance imaging [fMRI]-derived network analyses). We used linear mixed effects modeling with a random intercept to examine the effect of the intervention. The intervention improved healthy eating ( p = .08) but did not improve other self-management behaviors. There was a significant effect of the intervention on several aspects of neurocognitive processing including in the task positive network (TPN) differentiation ( p = .047) and an increase in the default mode network (DMN) differentiation ( p = .10). Self-management interventions may influence neurocognitive processing in PLHIV, but those changes were not associated with positive changes in self-management behavior.",2019,There was a significant effect of the intervention on several aspects of neurocognitive processing including in the task positive network (TPN) differentiation ( p = .047) and an increase in the default mode network (DMN) differentiation ( p = .10).,"['People living with HIV (PLHIV', 'Twenty-nine PLHIV']","['HIV Self-Management Intervention', 'self-management intervention', 'self-management intervention to improve physical activity and dietary intake']","['Neurocognitive Behavioral Processing', 'physical, diet, and neurocognitive processing (functional magnetic resonance imaging [fMRI]-derived network analyses', 'self-management behaviors', 'neurocognitive behavioral processing', 'default mode network (DMN) differentiation', 'healthy eating', 'task positive network (TPN) differentiation']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",29.0,0.0334739,There was a significant effect of the intervention on several aspects of neurocognitive processing including in the task positive network (TPN) differentiation ( p = .047) and an increase in the default mode network (DMN) differentiation ( p = .10).,"[{'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Webel', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Schreiner', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Friedman', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Jack', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fresco', 'Affiliation': '3 Kent State University, OH, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}]",Western journal of nursing research,['10.1177/0193945918823347']
2254,31539162,The application of dexmedetomidine combined with dezocine in thoracoscopic radical resection of lung cancer and its effect on awakening quality of patients.,"OBJECTIVE
The paper aims to explore the application of dexmedetomidine combined with dezocine in thoracoscopic radical resection of lung cancer and its effect on the awakening quality.
PATIENTS AND METHODS
122 patients undergoing thoracoscopic radical resection of lung cancer in The Affiliated Hospital of Qingdao University from April 2009 to January 2012 were selected as the subjects of the study. Among them, 68 patients were anesthetized with dexmedetomidine combined with dezocine as a study group, 54 patients with midazolam combined with fentanyl as a control group. The onset of anesthetic, operation time, awakening time, extubation time, and recovery time was compared. The mean arterial pressure (MAP), central venous pressure (CVP), and heart rate (HR) were compared before anesthesia (t0), at extubation (t1), 10 min after extubation (t2), and when patients left anesthesia recovery room (t3). The postoperative sedation score (Ramsay), modified the objective pain score (MOPS), and the pediatric anesthesia emergence delirium (PAED) score were compared at the time of the postoperative awakening (b1), 30 min after awakening (b2), 1 hour after awakening (b3), and 3 hours after awakening (b4).
RESULTS
There was no significant difference in MAP, CVP, and HR between the study group and the control group at t0 (p > 0.05). The scores of PAED at b3 and b4 in the study group were lower than those in the control group (p < 0.05).
CONCLUSIONS
The anesthesia effect of dexmedetomidine combined with dezocine in thoracoscopic radical resection of lung cancer is better and safer than other drugs, and it can produce good sedation and analgesic effect.",2019,"The scores of PAED at b3 and b4 in the study group were lower than those in the control group (p < 0.05).
","['68 patients were anesthetized with', '122 patients undergoing', 'of lung cancer in The Affiliated Hospital of Qingdao University from April 2009 to January 2012 were selected as the subjects of the study', 'patients', 'thoracoscopic radical resection of lung cancer', '54 patients with']","['dezocine', 'dexmedetomidine', 'midazolam combined with fentanyl', 'thoracoscopic radical resection']","['onset of anesthetic, operation time, awakening time, extubation time, and recovery time', 'MAP, CVP, and HR', 'awakening quality', 'scores of PAED', 'postoperative sedation score (Ramsay), modified the objective pain score (MOPS), and the pediatric anesthesia emergence delirium (PAED) score', 'mean arterial pressure (MAP), central venous pressure (CVP), and heart rate (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0057626', 'cui_str': 'dezocine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",2012.0,0.0410791,"The scores of PAED at b3 and b4 in the study group were lower than those in the control group (p < 0.05).
","[{'ForeName': 'Z-G', 'Initials': 'ZG', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, P.R. China. sjfdoctor@163.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'H-L', 'Initials': 'HL', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'X-Y', 'Initials': 'XY', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'X-L', 'Initials': 'XL', 'LastName': 'Yi', 'Affiliation': ''}, {'ForeName': 'J-F', 'Initials': 'JF', 'LastName': 'Song', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201909_18893']
2255,21378081,"Effect of stress and bupropion on craving, withdrawal symptoms, and mood in smokers.","INTRODUCTION
Studies suggest that in smokers attempting to quit smoking, the occurrence of stressful events is associated with smoking relapse. The purpose of this study was to determine the effect of bupropion (an agent known to increase smoking cessation rates) on the craving, withdrawal, and mood response to stressful tasks administered in a laboratory setting.
METHODS
Response to three tasks (a speech, math, and cold pressor task) was measured in 65 smokers during ad libitum smoking. Smokers were then randomized to either bupropion or placebo. Fourteen days after starting medication, 43 subjects (28 receiving bupropion and 15 receiving placebo) quit smoking and laboratory procedures were repeated on the third day of abstinence.
RESULTS
Prior to cessation, stressors presented in a laboratory setting increased craving, nicotine withdrawal symptoms, and subjective distress but decreased positive affect. Thirty minutes of relaxation after the stressors did not result in these measures returning to prestress levels. During the nicotine withdrawal period, stress-induced responses were generally smaller than during the precessation period. Bupropion (relative to placebo) reduced overall levels of craving and withdrawal symptoms but did not have significant effects on response to stress during the nicotine withdrawal period.
CONCLUSIONS
This study demonstrates that stress results in sustained increases in craving and withdrawal symptoms and changes in mood symptoms and that bupropion affects overall levels of these symptoms. Further research is needed to determine if modifying response to stress is predictive of an effective treatment for facilitating smoking cessation.",2011,"Bupropion (relative to placebo) reduced overall levels of craving and withdrawal symptoms but did not have significant effects on response to stress during the nicotine withdrawal period.
","['43 subjects (28 receiving', 'in smokers', '65 smokers during ad libitum smoking']","['bupropion', 'placebo', 'bupropion or placebo', 'stress and bupropion', 'bupropion and 15 receiving placebo', 'Bupropion']","['craving, withdrawal symptoms, and mood', 'overall levels of craving and withdrawal symptoms', 'craving, nicotine withdrawal symptoms, and subjective distress', 'craving and withdrawal symptoms and changes in mood symptoms', 'smoking cessation rates']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.117422,"Bupropion (relative to placebo) reduced overall levels of craving and withdrawal symptoms but did not have significant effects on response to stress during the nicotine withdrawal period.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kotlyar', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 7-170 Weaver Densford Hall, 308 Harvard Street SE, Minneapolis, MN 55455, USA. kotly001@umn.edu'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Drone', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thuras', 'Affiliation': ''}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brauer', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Adson', 'Affiliation': ''}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""al'Absi"", 'Affiliation': ''}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntr011']
2256,20932370,Comparison of laparoscopy training using the box trainer versus the virtual trainer.,"BACKGROUND AND OBJECTIVES
To evaluate whether training on a virtual reality laparoscopic simulator improves the performance on a laparoscopic box trainer.
METHODS
Twenty-six subjects were trained using a box trainer, and 17 participants were trained using a virtual simulator. Participants in the experimental group completed 1 session of 5 exercises on the box trainer, 4 sessions on the virtual simulator, and a final session on the box trainer. Participants in the control group completed 6 sessions of 5 exercises on the box trainer alone. Exercises were monitored and scored for time and accuracy. Participants completed a self-evaluation survey after each session and a user satisfaction questionnaire at the end of the training.
RESULTS
No significant difference existed between the 2 groups in improvement of accuracy. Pegboard time (P=0.0110) and pattern cutting time (P=0.0229) were the only exercise parameters that improved significantly more in the control group compared with the experimental group. The experimental group developed more interest in a surgical field as a result of their experience than the control group did (70.6% vs 53.8%, respectively).
CONCLUSION
The virtual simulator is a reasonable alternative to the box trainer for laparoscopic skills training.",2010,Pegboard time (P=0.0110) and pattern cutting time (P=0.0229) were the only exercise parameters that improved significantly more in the control group compared with the experimental group.,"['Twenty-six subjects were trained using a box trainer, and 17 participants were trained using a virtual simulator']","['5 exercises on the box trainer alone', 'laparoscopy training', 'virtual reality laparoscopic simulator']","['accuracy', 'Pegboard time', 'pattern cutting time']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",26.0,0.023026,Pegboard time (P=0.0110) and pattern cutting time (P=0.0229) were the only exercise parameters that improved significantly more in the control group compared with the experimental group.,"[{'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Public Health, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Lerner', 'Affiliation': ''}, {'ForeName': 'Amanjot S', 'Initials': 'AS', 'LastName': 'Sethi', 'Affiliation': ''}, {'ForeName': 'Chandru P', 'Initials': 'CP', 'LastName': 'Sundaram', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680810X12785289144115']
2257,32493217,Cardiotoxicity evaluation using magnetic resonance imaging in breast Cancer patients (CareBest): study protocol for a prospective trial.,"BACKGROUND
Cardiovascular disease is second only to cancer recurrence as a determinant of lifespan in cancer survivors, and cancer therapy-related cardiac dysfunction is a clinically important risk factor. We aim to investigate the use of cardiac magnetic resonance imaging (MRI) to evaluate early tissue changes and perform functional assessment of chemo- and radiation-induced cardiotoxicity and to identify MRI prognostic indicators of cardiotoxicity in breast cancer patients.
METHODS
A 3-min cardiac imaging protocol will be added to the breast MRI examination to diagnose cardiotoxicity in breast cancer patients. Standardized MRI-based evaluation of breast cancer and the left ventricular myocardium will be performed at baseline and at 3, 6, and 12 months and 2 years or more after cancer treatment. We will analyze both ventricular volume and ejection fraction (EF), strain of left ventricle (LV), native T1, extracellular volume fraction (ECV), and T2 values acquired in the mid LV.
DISCUSSION
The primary result of this study will be the comparison of the prognostic value of MRI parameters (native T1, ECV, both ventricular systolic function and LV strain) for cardiotoxicity. The endpoint is defined as the occurrence of a major adverse cardiac event (MACE). The secondary outcome will be an assessment of the temporal relationships between contractile dysfunction and microstructural injury over 4 years using MRI. This study will assess the usefulness of quantitative MRI to diagnose cardiotoxicity and will clarify the temporal relationships between contractile dysfunction and microstructural injury of the LV myocardium using MRI during breast cancer treatment.
TRIAL REGISTRATION
The protocol was registered at clinicaltrials.gov (Clinical trial no. NCT03301389) on October 4, 2017.",2020,"This study will assess the usefulness of quantitative MRI to diagnose cardiotoxicity and will clarify the temporal relationships between contractile dysfunction and microstructural injury of the LV myocardium using MRI during breast cancer treatment.
","['breast cancer patients', 'breast Cancer patients (CareBest']","['cardiac magnetic resonance imaging (MRI', 'chemo- and radiation-induced cardiotoxicity', 'magnetic resonance imaging']","['ventricular volume and ejection fraction (EF), strain of left ventricle (LV), native T1, extracellular volume fraction (ECV), and T2 values acquired in the mid LV', 'occurrence of a major adverse cardiac event (MACE', 'prognostic value of MRI parameters (native T1, ECV, both ventricular systolic function and LV strain) for cardiotoxicity', 'Cardiotoxicity evaluation', 'contractile dysfunction and microstructural injury over 4\u2009years using MRI']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0698136,"This study will assess the usefulness of quantitative MRI to diagnose cardiotoxicity and will clarify the temporal relationships between contractile dysfunction and microstructural injury of the LV myocardium using MRI during breast cancer treatment.
","[{'ForeName': 'Yoo Jin', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Gun Min', 'Initials': 'GM', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyunghwa', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Pan Ki', 'Initials': 'PK', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Su An', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Eunkyung', 'Initials': 'E', 'LastName': 'An', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Hye-Jeong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Hur', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea. MINES@yuhs.ac.'}, {'ForeName': 'Byoung Wook', 'Initials': 'BW', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea. bchoi305@gmail.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01497-y']
2258,21189847,"Comparative study between I-gel, a new supraglottic airway device, and classical laryngeal mask airway in anesthetized spontaneously ventilated patients.","OBJECTIVE
To compare two different supraglottic airway devices, the laryngeal mask airway (LMA) and the I-gel, regarding easiness of insertion of the device, leak pressure, gastric insufflation, end tidal CO(2), oxygen saturation, hemodynamic and postoperative complications in anesthetized, spontaneously ventilated adult patients performing different non-emergency surgical procedures.
MATERIALS AND METHODS
The study was carried out as a prospective, randomized, clinical trial among 80 patients who underwent different surgical procedures under general anesthesia with spontaneous ventilation in supine position. They were equally randomized into two groups: I-gel and LMA groups. Both the devices were compared with regard to heart rate, arterial BP, SPO(2), end-tidal CO(2), number and duration of insertion attempts, incidence of gastric insufflation, leak pressure and airway assessment after removal of the device.
RESULTS
No statistically significant difference was reported between both the groups, regarding heart rate, arterial BP, SPO(2) and end-tidal CO(2). The mean duration of insertion attempts was 15.6±4.9 seconds in the I-gel group, while it was 26.2±17.7 seconds in the LMA group. The difference between both the groups regarding duration of insertion attempts was statistically significant (P=0.0023*), while the number of insertion attempts was statistically insignificant between both the study groups (P>0.05). Leak pressure was (25.6±4.9 vs. 21.2±7.7 cm H(2)O) significantly higher among studied patients of the I-gel group (P=0.016*) and the incidence of gastric insufflation was significantly more with LMA group 9 (22.5%) vs. I-gel group (5%) (P=0.016).
CONCLUSION
Both LMA and I-gel do not cause any significant alteration in the hemodynamic status of the patients, end tidal CO(2), and SPO(2). The postoperative complications were not significantly different except nusea and vomiting was statistically significant higher in LMA group (P=0.032). among both LMA and I-gel patients. Insertion of I-gel was significantly easier and more rapid than insertion of LMA. Leak pressure was significantly higher with I-gel than LMA and thus incidence of gastric insufflation was significantly lower with I-gel.",2010,"The difference between both the groups regarding duration of insertion attempts was statistically significant (P=0.0023*), while the number of insertion attempts was statistically insignificant between both the study groups (P>0.05).","['80 patients who underwent different surgical procedures under general anesthesia with spontaneous ventilation in supine position', 'anesthetized spontaneously ventilated patients', 'anesthetized, spontaneously ventilated adult patients performing different non-emergency surgical procedures']","['new supraglottic airway device, and classical laryngeal mask airway', 'laryngeal mask airway (LMA', 'LMA']","['vomiting', 'duration of insertion attempts', 'incidence of gastric insufflation', 'heart rate, arterial BP, SPO(2), end-tidal CO(2), number and duration of insertion attempts, incidence of gastric insufflation, leak pressure and airway assessment after removal of the device', 'heart rate, arterial BP, SPO(2) and end-tidal CO(2', 'postoperative complications', 'Leak pressure', 'number of insertion attempts', 'device, leak pressure, gastric insufflation, end tidal CO(2), oxygen saturation, hemodynamic and postoperative complications', 'mean duration of insertion attempts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",80.0,0.0421104,"The difference between both the groups regarding duration of insertion attempts was statistically significant (P=0.0023*), while the number of insertion attempts was statistically insignificant between both the study groups (P>0.05).","[{'ForeName': 'Amr M', 'Initials': 'AM', 'LastName': 'Helmy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Hossam M', 'Initials': 'HM', 'LastName': 'Atef', 'Affiliation': ''}, {'ForeName': 'Ezzat M', 'Initials': 'EM', 'LastName': 'El-Taher', 'Affiliation': ''}, {'ForeName': 'Ahmed Mosaad', 'Initials': 'AM', 'LastName': 'Henidak', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.71250']
2259,31395416,Effects of birth weight on body composition and overweight/obesity at early school age.,"OBJECTIVES
The prevalence of childhood obesity has increased substantially. We aimed to characterize the effect of birth weight on body composition and overweight/obesity at early school age.
STUDY DESIGN
A total of 1669 children with available birth records from a double-blind cluster-randomized controlled trial exploring micronutrient supplementation during pregnancy were included. Data regarding school-aged body composition, social-demographic factors and health behaviours were prospectively collected.
RESULT
s: The study population consisted of 1004 boys and 665 girls aged between 7 and 10 years. The prevalence of overweight/obesity (>85th age-sex-specific percentiles) was 7.4% for boys and 5.0% for girls. Generalized estimating equation models were used to account for the cluster nature of the data. A significant upward trend across quintiles of birth weight was observed for fat mass index (boys: P for trend 0.002; girls: P for trend <0.001), fat-free mass index (boys: P for trend <0.001; girls: P for trend <0.001), and percentage of body fat (boys: P for trend 0.003; girls: P for trend <0.001). A birth weight in the higher three quintiles could increase the risk ratios [RRs (95% CI) third quintile: 2.88, (1.13, 7.32); fourth quintile: 2.40, (0.87, 6.66); top quintile: 2.31, (0.92, 5.80)] of overweight/obesity at early school age compared with the RRs of the reference group (the second quintile of birth weight) among boys.
CONCLUSIONS
Higher birth weight could increase the risk of being overweight/obese among 7- to 10-year-old boys in rural western China. Sex differences in this association need to be considered when planning interventions.
RESEARCH REGISTRATION
This trial was registered at www.isrctn.com with the identifier ISRCTN08850194.",2020,"A significant upward trend across quintiles of birth weight was observed for fat mass index (boys: P for trend 0.002; girls: P for trend <0.001), fat-free mass index (boys: P for trend <0.001; girls: P for trend <0.001), and percentage of body fat (boys: P for trend 0.003; girls: P for trend <0.001).","['1004 boys and 665 girls aged between 7 and 10 years', 'overweight/obesity (>85th age-sex-specific percentiles) was 7.4% for boys and 5.0% for girls', '1669 children with available birth records from a double-blind cluster-randomized controlled trial exploring', 'body composition and overweight/obesity at early school age']",['micronutrient supplementation'],"['fat-free mass index', 'quintiles of birth weight', 'percentage of body fat', 'risk ratios [RRs', 'body composition and overweight/obesity']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005609', 'cui_str': 'Birth Records'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",1669.0,0.143084,"A significant upward trend across quintiles of birth weight was observed for fat mass index (boys: P for trend 0.002; girls: P for trend <0.001), fat-free mass index (boys: P for trend <0.001; girls: P for trend <0.001), and percentage of body fat (boys: P for trend 0.003; girls: P for trend <0.001).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, PR China.""}, {'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, PR China.""}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinic Science, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, PR China.""}, {'ForeName': 'Yuesheng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, PR China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, PR China; Nutrition and Food Safety Engineering Research Center of Shaanxi Province, Xi'an, Shaanxi, PR China; Key Laboratory of Environment and Genes Related to Diseases (Xi'an Jiaotong University), Ministry of Education, Xi'an, Shaanxi, 710061, China.""}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, PR China. Electronic address: xyf_xjtu@163.com.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.07.013']
2260,32423937,"Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women: a protocol for a randomised, placebo-controlled, double-blind feasibility trialOptimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA).","INTRODUCTION
Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial.
METHODS AND ANALYSIS
Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1 year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs.
ETHICS AND DISSEMINATION
The OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie's Team) and through social media platforms.
TRIAL REGISTRATION NUMBER
ISRCTN20930880.",2020,"The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study.","['women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5\u2009years after delivery', 'type 2 diabetes after gestational diabetes in postnatal women', '160 postnatal women with gestational diabetes treated with medication to either', 'diAbetes After pregnancy (OMAhA', 'to prevent diAbetes After pregnancy', 'postnatal women with a history of gestational diabetes']","['Metformin', 'metformin versus placebo', 'metformin', 'metformin (intervention) or placebo (control) tablets', 'placebo']","['maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention', 'rates of recruitment, randomisation, adherence and attrition', 'Effectiveness and acceptability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",160.0,0.592804,"The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study.","[{'ForeName': 'Chiamaka Esther', 'Initials': 'CE', 'LastName': 'Amaefule', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK c.e.amaefule@qmul.ac.uk.""}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Bolou', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Drymoussi', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Gonzalez Carreras', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Maria Del Carmen', 'Initials': 'MDC', 'LastName': 'Pardo Llorente', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Sweeney', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pizzo', 'Affiliation': 'Collaborations for Leadership in Applied Health Research and Care (CLAHRC) for North Thames London, Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Amico"", 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Heighway', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Jahnavi', 'Initials': 'J', 'LastName': 'Daru', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Sobhy', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robson', 'Affiliation': 'Clinical Effectiveness Group, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sanghi', 'Affiliation': ""Women's Division, Royal London Hospital, Barts Health NHS Trust, London, UK.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Clinical Biostatistics Unit (IRYCIS) and CIBER Epidemiology and Public Health, Ramon y Cajal University Hospital, Madrid, Spain.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Harden', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Hitman', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pérez', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Mohammed Sb', 'Initials': 'MS', 'LastName': 'Huda', 'Affiliation': 'Department of Diabetes and Metabolism, Barts Health NHS Trust, Royal London Hospital, London, UK.'}, {'ForeName': 'Shakila', 'Initials': 'S', 'LastName': 'Thangaratinam', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2019-036198']
2261,21035610,Depression vulnerability moderates the effects of cognitive behavior therapy in a randomized controlled trial for smoking cessation.,"Several clinical trials have tested the hypothesis that smoking cessation treatments with a mood management component derived from cognitive behavior therapy (CBT) for depression would be specifically effective for depression-vulnerable smokers, with mixed results. This trial addressed methodological concerns with some of the previous studies to clarify whether depression vulnerability does in fact moderate CBT smoking cessation outcome. The study compared 8-session group CBT with a time-matched comparison group condition in a sample of 100 cigarette smokers randomized to treatment condition. Each treatment group was led by one of 7 American University clinical psychology graduate students; therapists were crossed with treatment conditions. Outcome (7-day point prevalence abstinence) was evaluated 1 month and 3 months after quit date. Baseline self-reported depression vulnerability (sample median split on the Depression Proneness Inventory) moderated treatment response, such that more depression-prone smokers fared better in CBT whereas less depression-prone smokers fared better in the comparison condition. These results may have implications for determining when to use CBT components in smoking cessation programs.",2010,"Baseline self-reported depression vulnerability (sample median split on the Depression Proneness Inventory) moderated treatment response, such that more depression-prone smokers fared better in CBT whereas less depression-prone smokers fared better in the comparison condition.","['100 cigarette smokers randomized to treatment condition', '7 American University clinical psychology graduate students; therapists']","['CBT', 'cognitive behavior therapy', 'cognitive behavior therapy (CBT']",[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0033912', 'cui_str': 'Psychology, Clinical'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],100.0,0.0181887,"Baseline self-reported depression vulnerability (sample median split on the Depression Proneness Inventory) moderated treatment response, such that more depression-prone smokers fared better in CBT whereas less depression-prone smokers fared better in the comparison condition.","[{'ForeName': 'Heather Schloss', 'Initials': 'HS', 'LastName': 'Kapson', 'Affiliation': 'Department of Psychology, American University, Washington, DC 20016-8062, USA.'}, {'ForeName': 'David A F', 'Initials': 'DA', 'LastName': 'Haaga', 'Affiliation': ''}]",Behavior therapy,['10.1016/j.beth.2009.10.001']
2262,20932368,"Saving time during laparoscopy using a new, wall anchoring trocar device.","OBJECTIVE
Safe and reliable access systems are crucial in laparoscopy, and trocar dislodgement is still a common and frustrating problem. Wall emphysema can occur besides the risky prolongation of the surgical procedure. Wall-anchoring components provide a better hold of the device. This comparative analysis assesses the frequency of dislodgement and a time-sparing effect on the intervention of 3 different trocar systems, including an innovation in the field of access-providing systems.
METHODS
Patients who underwent laparoscopy for various gynecological indications were included and randomized consecutively into 3 groups according to the access system used in the intervention: (A) trocar fitted with a spiral thread on the sleeve, (B) trocar with plain sleeve, (C) trocar as in B together with a fixator. This novelty is installed on the trocar before insertion and then sutured to the abdominal wall. Intervention time, frequency of trocar corrections, and the time loss through correction were registered. Standard statistical analyses were performed.
RESULTS
The cohort comprised 131 patients; 51 patients were consecutively randomized into group A, 38 into group B, and 42 into group C. Mean intervention time was different, shortest in C and highest in B. Frequency of interruption of the intervention due to adjustment of the device and time loss through adjustment was lowest in group C (fixator + plain sleeve) and highest in group B (plain-sleeve) (0.47 vs 0.29, P<0.05 and 2.13 minutes vs 0.69 minutes, P<0.05).
CONCLUSION
Wall-anchoring components lead to higher stability of ports and have a time-sparing effect. Comparing the 2 trocar groups with wall-anchoring properties (trocar with thread-fitted sleeve vs fixator + trocar with plain sleeve), the mean operation time was lowest in the fixator group, and the time-saving effect was higher.",2010,"This comparative analysis assesses the frequency of dislodgement and a time-sparing effect on the intervention of 3 different trocar systems, including an innovation in the field of access-providing systems.
","['131 patients; 51 patients', 'Patients who underwent laparoscopy for various gynecological indications']","['wall-anchoring properties (trocar with thread-fitted sleeve vs fixator + trocar with plain sleeve', 'access system used in the intervention: (A) trocar fitted with a spiral thread on the sleeve, (B) trocar with plain sleeve, (C) trocar as in B together with a fixator']","['mean operation time', 'Intervention time, frequency of trocar corrections, and the time loss through correction', 'Saving time', 'Mean intervention time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0441254', 'cui_str': 'Fixator (physical object)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0522554', 'cui_str': 'Spiral'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}]",131.0,0.0204991,"This comparative analysis assesses the frequency of dislodgement and a time-sparing effect on the intervention of 3 different trocar systems, including an innovation in the field of access-providing systems.
","[{'ForeName': 'Garri', 'Initials': 'G', 'LastName': 'Tchartchian', 'Affiliation': 'Department of Obstetrics and Gynecology, Pius-Clinic, Oldenburg, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Dietzel', 'Affiliation': ''}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Surrey', 'Affiliation': ''}, {'ForeName': 'Rudy L', 'Initials': 'RL', 'LastName': 'Dewilde', 'Affiliation': ''}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Bojahr', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680810X12785289144034']
2263,20927267,Comparison of classic peribulbar anesthesia and new entry point (single percutaneous injection technique) in vitroretinal surgery.,"PURPOSE
To describe the method that seeks to improve the administration of regional anesthesia for vitroretinal surgery avoiding the risk of potential complications associated with other techniques through comparison of safety and efficacy of classic peribulbar anesthesia versus single percutaneous technique using a prospective, randomized clinical trial.
MATERIALS AND METHODS
One hundred patients were randomized to classic peribulbar and single percutaneous peribulbar technique after informed consent. Pain during administration of anesthesia, during surgery was graded on a visual analogue pain scale and compared for both techniques. Globe akinesia, analgesia and IOP measurements before and after administration of anesthesia, detection of distribution of local anesthetic agent by ultrasound scanning and complications related were also compared.
RESULTS
Twenty out of 50 (40%) patients of group 1(classic pirebulbar) and 36/50 (72%) of group II (single percutaneous technique) experience no pain during administration of anesthesia. Scores for globe akinesia and anesthesia were less satisfactory in group 1 and supplemental blocks required in 8% of the patients while in group II all of the patients (100%) showed proper globe akinesia and anesthesia. There were significant elevation in mean IOP following injection in both groups and the incidence of subconjunctival haemorrhage, chemosis and echymosis were more frequent in group 1.
CONCLUSION
Single percutaneous peribulbar technique proved to be a safe and efficient technique that offers excellent anesthesia and akinesia with less complication for various ophthalmic procedures.",2010,"There were significant elevation in mean IOP following injection in both groups and the incidence of subconjunctival haemorrhage, chemosis and echymosis were more frequent in group 1.
","['Twenty out of 50 (40%) patients of group 1(classic pirebulbar) and 36/50 (72%) of group II (single percutaneous technique', 'One hundred patients', 'vitroretinal surgery']","['classic peribulbar anesthesia versus single percutaneous technique', 'classic peribulbar and single percutaneous peribulbar technique', 'anesthesia', 'classic peribulbar anesthesia and new entry point (single percutaneous injection technique']","['visual analogue pain scale', 'pain', 'mean IOP', 'Pain', 'Globe akinesia, analgesia and IOP measurements', 'globe akinesia and anesthesia', 'subconjunctival haemorrhage, chemosis and echymosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0457431', 'cui_str': 'Percutaneous techniques (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0457431', 'cui_str': 'Percutaneous techniques (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}]","[{'cui': 'C0042815', 'cui_str': 'Visual Analog Pain Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085623', 'cui_str': 'Akinesia (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0271298', 'cui_str': 'Chemosis of conjunctiva (disorder)'}]",100.0,0.0397885,"There were significant elevation in mean IOP following injection in both groups and the incidence of subconjunctival haemorrhage, chemosis and echymosis were more frequent in group 1.
","[{'ForeName': 'Tarek M', 'Initials': 'TM', 'LastName': 'El Said', 'Affiliation': 'Department of Anesthesiology, Al-Azhar University, Egypt.'}, {'ForeName': 'Mamdouh Mahmoud', 'Initials': 'MM', 'LastName': 'Kabeel', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.65130']
2264,20927262,Comparison of epidural ropivacaine and ropivacaine clonidine combination for elective cesarean sections.,"BACKGROUND AND AIM
Neuraxial adjuvants augment the action of local anesthetics. The aim is to determine the qualitative and quantitative aspects of epidural block of ropivacaine 0.75% versus ropivacaine 0.75% with clonidine for elective cesarean section.
SETTINGS AND DESIGN
A randomized double-blind study was conducted among 51 healthy parturients, scheduled for elective cesarean section, at Gian Sagar Medical College and Hospital, Banur, Punjab, India.
MATERIALS AND METHODS
Epidural block was administered with 20 ml of ropivacaine 0.75% (group R) and ropivacaine 0.75% and clonidine 75 µg (group RC) and anesthetic level was achieved minimum until T6-T7 dermatome. Onset time of analgesia, sensory and motor block levels, maternal heart rate and blood pressure, neonatal Apgar scores, postoperative analgesic dose and adverse events were recorded.
RESULTS
Fifty one patients were enrolled in this study and were subjected to statistical analysis. Groups were comparable with regard to demographic data, neonatal Apgar scores and incidences of side effects except for the higher incidence of dry mouth in patients of RC group. Onset of analgesia was much shorter in RC group along with prolonged duration of analgesia. The incidence of bradycardia and hypotension was more in RC group as compared to R group which was statistically significant. The dose requirement for postoperative pain relief was significantly lesser in RC group.
CONCLUSIONS
The addition of 75 µg clonidine to isobaric epidural ropivacaine results in longer, complete and effective analgesia with similar block properties and helped to reduce the effective dose of ropivacaine when compared with plain ropivacaine for cesarean delivery.",2010,"Groups were comparable with regard to demographic data, neonatal Apgar scores and incidences of side effects except for the higher incidence of dry mouth in patients of RC group.","['Fifty', 'elective cesarean sections', '51 healthy parturients, scheduled for elective cesarean section, at Gian Sagar Medical College and Hospital, Banur, Punjab, India']","['ropivacaine clonidine combination', 'epidural ropivacaine', 'clonidine', 'ropivacaine', 'plain ropivacaine']","['incidence of bradycardia and hypotension', 'demographic data, neonatal Apgar scores and incidences of side effects', 'postoperative pain relief', 'Onset time of analgesia, sensory and motor block levels, maternal heart rate and blood pressure, neonatal Apgar scores, postoperative analgesic dose and adverse events']","[{'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",51.0,0.149627,"Groups were comparable with regard to demographic data, neonatal Apgar scores and incidences of side effects except for the higher incidence of dry mouth in patients of RC group.","[{'ForeName': 'Sukhminder Jit Singh', 'Initials': 'SJ', 'LastName': 'Bajwa', 'Affiliation': 'Gian Sagar Medical College and Hospital, Banur, Patiala, Punjab, India.'}, {'ForeName': 'Sukhwinder Kaur', 'Initials': 'SK', 'LastName': 'Bajwa', 'Affiliation': ''}, {'ForeName': 'Jasbir', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.65119']
2265,20927263,Does the use of ketamine or nitroglycerin as an adjuvant to lidocaine improve the quality of intravenous regional anesthesia?,"AIMS
To compare and evaluate the effect of adding ketamine or nitroglycerin (NTG) as adjuncts to lidocaine for intravenous regional anesthesia (IVRA) on intraoperative and postoperative analgesia, sensorial and motor block onset times, and tourniquet pain.
SETTINGS AND DESIGN
A prospective, randomized, double-blind study was carried out.
MATERIALS AND METHODS
Seventy-five patients undergoing hand surgery were divided into three groups as follows: control group receiving lidocaine 2%, LK group receiving lidocaine 2% with ketamine, and LN group administered lidocaine 2% with NTG. Sensory and motor blocks' onset and recovery times were recorded. Visual analog scale (VAS) for tourniquet pain was measured after tourniquet application and it was also used to measure postoperative pain. Analgesic consumption for tourniquet pain and postoperatively were recorded.
RESULTS
Sensory block onset times were shorter in the LK (4.4 ± 1.2 minutes) and LN (3.5 ± 0.9 minutes) groups compared with the control group (6.5 ± 1.1 minute) (P < 0.0001) and motor block onset times were shorter in the LK (7.3 ± 1.6 minutes) and LN (3.6 ± 1.2 minutes) groups compared with the control group (10.2 ± 1.5 minutes) (P< 0.0001). Sensory recovery time prolonged in the LK (6.7 ± 1.3 minutes) and LN (6.9 ± 1.1 minutes) groups compared with the control group (5.3 ± 1.4 minutes) (P = 0.0006 and < 0.0001, respectively). Motor recovery time prolonged in the LK (8.4 ± 1.4 minutes) and LN (7.9 ± 1.1 minutes) groups compared with the control group (7.1 ± 1.3 minutes) (P = 0.0014 and 0.023, respectively). The sensory and motor block onset times were also shorter in LN group than in the LK group (3.5 ± 0.9 versus 4.4 ± 1.2 minutes, P=0.004; and 3.6 ± 1.2 versus 7.3 ± 1.6 minutes, P < 0.0001, respectively). The amount of fentanyl required for tourniquet pain was less in adjuvant groups when compared with control group. It was 13.6 ± 27.9 and 27.6 ± 34.9 µg in LK group and LN groups, respectively, versus 54.8 ± 28 µg in the control group. VAS scores of tourniquet pain were higher at 10, 20, 30, 40 minutes in the control group compared with the other study groups (P < 0.0001). It was also higher in LN group compared with LK group at 30 and 40 minutes (P < 0.001). Postoperative VAS scores were higher for the first 4 h in control group compared with the other study groups (P< 0.0001).
CONCLUSIONS
The adjuvant drugs (ketamine or NTG) when added to lidocaine in IVRA were effective in improving the overall quality of anesthesia, reducing tourniquet pain, increasing tourniquet tolerance and improving the postoperative analgesia in comparison to the control group. Ketamine as an adjuvant produced better tolerance to tourniquet than the other groups. NTG as an adjuvant produced faster onset of sensory and motor blockades in comparison to other groups.",2010,"VAS scores of tourniquet pain were higher at 10, 20, 30, 40 minutes in the control group compared with the other study groups (P < 0.0001).",['Seventy-five patients undergoing hand surgery'],"['NTG', 'LK', 'lidocaine', 'ketamine or nitroglycerin (NTG', 'ketamine or nitroglycerin', 'Ketamine', 'adjuvant drugs (ketamine or NTG', 'control group receiving lidocaine 2%, LK group receiving lidocaine 2% with ketamine, and LN group administered lidocaine 2% with NTG']","['Visual analog scale (VAS) for tourniquet pain', 'tourniquet pain', 'Postoperative VAS scores', 'overall quality of anesthesia, reducing tourniquet pain, increasing tourniquet tolerance and improving the postoperative analgesia', 'sensory and motor blockades', 'Motor recovery time', 'Sensory recovery time', 'motor block onset times', ""Sensory and motor blocks' onset and recovery times"", 'sensory and motor block onset times', 'postoperative pain', 'quality of intravenous regional anesthesia', 'VAS scores of tourniquet pain', 'Sensory block onset times', 'intraoperative and postoperative analgesia, sensorial and motor block onset times, and tourniquet pain']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",75.0,0.0695295,"VAS scores of tourniquet pain were higher at 10, 20, 30, 40 minutes in the control group compared with the other study groups (P < 0.0001).","[{'ForeName': 'Khaled Fawzy', 'Initials': 'KF', 'LastName': 'Elmetwaly', 'Affiliation': 'Assistant Professor of Anesthesia, College of Medicine, Ain Shames University, Cairo, Egypt.'}, {'ForeName': 'Nasr Abdelmohsen', 'Initials': 'NA', 'LastName': 'Hegazy', 'Affiliation': ''}, {'ForeName': 'Abdelkhalek Abdelmonem', 'Initials': 'AA', 'LastName': 'Aboelseoud', 'Affiliation': ''}, {'ForeName': 'Ahmad Abdullah', 'Initials': 'AA', 'LastName': 'Alshaer', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.65122']
2266,32493211,"Dural sac cross-sectional area is a highly effective parameter for spinal anesthesia in geriatric patients undergoing transurethral resection of the prostate: a prospective, double blinded, randomized study.","BACKGROUND
Spinal anesthesia is optimal choice for transurethral resection of the prostate (TURP), but the sensory block should not cross the T10 level. With advancing age, the sensory blockade level increases after spinal injection in some patients with spinal canal stenosis. We optimize the dose of spinal anesthesia according to the decreased ratio of the dural sac cross-sectional area (DSCSA), the purpose of this study is to hypothesis that if DSCSA is an effective parameter to modify the dosage of spinal anesthetics to achieve a T10 blockade in geriatric patients undergoing TURP.
METHODS
Sixty geriatric patients schedule for TURP surgery were enrolled in this study. All subjects were randomized divided into two groups, the ultrasound (group U) and the control (group C) groups, patient receive either a dose of 2 ml of 0.5% isobaric bupivacaine in group C, or a modified dose of 0.5% isobaric bupivacaine in group U. We measured the sagittal anteroposterior diameter (D) of the dural sac at the L3-4 level with ultrasound, and calculated the approximate DSCSA (A) according to the following formula: A = π(D/2) 2 , ( π = 3.14). The modified dosage of bupivacaine was adjusted according to the decreased ratio of the DSCSA.
RESULTS
The cephalad spread of the sensory blockade level was significantly lower (P < 0.001) in group U (T10, range T7-T12) compared with group C (T3, range T2-T9). The dosage of bupivacaine was significantly decreased in group U compared with group C (P < 0.001). The regression times of the two segments were delay in group U compared with group C (P < 0.001). The maximal decrease in MAP was significantly higher in the group C than in group U after spinal injection (P < 0.001), without any modifications HR in either group. Eight patients in group C and two patients in group U required ephedrine (P = 0.038).
CONCLUSIONS
The DSCSA is a highly effective parameter for spinal anesthesia in geriatric patients undergoing TURP, a modified dose of local anesthetic is a critical factor for controlling the sensory level.
TRIAL REGISTRATION
This study was registered in the Chinese Clinical Trial Registry (Registration number: ChiCTR1800015566).on 8, April, 2018.",2020,"The cephalad spread of the sensory blockade level was significantly lower (P < 0.001) in group U (T10, range T7-T12) compared with group C (T3, range T2-T9).","['Sixty geriatric patients schedule for TURP surgery were enrolled in this study', 'geriatric patients undergoing transurethral resection of the prostate', 'geriatric patients undergoing TURP', 'geriatric patients undergoing', 'patients with spinal canal stenosis']","['TURP', 'bupivacaine', 'DSCSA', 'modified dose of 0.5% isobaric bupivacaine', 'patient receive either a dose of 2\u2009ml of 0.5% isobaric bupivacaine', 'spinal anesthesia', 'ephedrine']","['sagittal anteroposterior diameter (D) of the dural sac', 'cephalad spread of the sensory blockade level', 'maximal decrease in MAP']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1861329', 'cui_str': 'Spinal canal stenosis'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",60.0,0.0363662,"The cephalad spread of the sensory blockade level was significantly lower (P < 0.001) in group U (T10, range T7-T12) compared with group C (T3, range T2-T9).","[{'ForeName': 'Wei Bing', 'Initials': 'WB', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China. w2bwang@sina.com.'}, {'ForeName': 'Ai Jiao', 'Initials': 'AJ', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}, {'ForeName': 'Hong Ping', 'Initials': 'HP', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}, {'ForeName': 'Jing Chun', 'Initials': 'JC', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01059-x']
2267,31529471,Comparing the efficacy of field treatments for actinic keratosis: a critical appraisal of a randomized trial in the New England Journal of Medicine.,"AIM
Jansen et al. conducted a randomized trial to compare the efficacy of four field treatments for actinic keratosis (AK).
SETTING AND DESIGN
This was a multicentre, single-blind, randomized trial conducted in the dermatology departments of four Netherlands hospitals. Patients were not blinded. The investigator who evaluated the trial outcome was blinded.
STUDY EXPOSURE
This study included adult patients with at least five AKs on the face or vertex scalp. Patients were randomized to treatment with fluorouracil 5% cream, imiquimod 5% cream, methyl aminolaevulinate photodynamic therapy (MAL-PDT) or ingenol mebutate 0·015% gel.
OUTCOMES
The primary outcome was whether patients had ≥ 75% reduction in AK count 12 months after treatment.
RESULTS
In total 624 patients participated. The likelihood of having ≥ 75% reduction in AK count 12 months after treatment was significantly higher (twice as high or greater) for fluorouracil than for any other therapy. Approximately 75% of patients treated with fluorouracil experienced ≥ 75% reduction in AK count at 12 months.
CONCLUSIONS
Jansen et al. conclude that 1 year after treatment, fluorouracil was significantly more effective at AK reduction than imiquimod, MAL-PDT or ingenol mebutate.",2020,The likelihood of having at least a 75% reduction in AK count 12 months after treatment was significantly higher (twice as high or greater) for fluorouracil than for any other therapy.,"['624 patients participated', 'actinic keratosis (AK', 'dermatology departments of four Netherlands hospitals', 'adult patients with at least five AKs on the face or vertex scalp', 'actinic keratosis']","['5% fluorouracil cream, 5% imiquimod cream, methyl aminolevulinate photodynamic therapy (MAL-PDT), or 0.015% ingenol mebutate gel', 'fluorouracil']",['AK count'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0587461', 'cui_str': 'Dermatology department (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C1134467', 'cui_str': 'methyl aminolevulinate'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C4517396', 'cui_str': 'Zero point zero one five'}, {'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",624.0,0.167952,The likelihood of having at least a 75% reduction in AK count 12 months after treatment was significantly higher (twice as high or greater) for fluorouracil than for any other therapy.,"[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Wehner', 'Affiliation': 'Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18537']
2268,31531547,Carnitine analysis in pterygium.,"PURPOSE
The aim of the present study was to measure the free carnitine and acylcarnitine levels in pterygium tissue and normal conjunctival tissue at the metabolomics level using tandem mass spectrometry.
METHODS
In this prospective, clinical randomized study, pterygium tissues and normal conjunctival tissues taken during pterygium excision with autograft were compared regarding their free carnitine and acylcarnitine profiles. After tissue homogenization, carnitine levels were measured using tandem mass spectrometry. The data were statistically analyzed with the Wilcoxon signed-rank test.
RESULTS
Pterygium and normal conjunctival tissue samples from a single eye of 29 patients (16 females, 13 males; mean age, 54.75 ± 11.25 years [range, 21-78 years]) were evaluated. While the free carnitine (C0) level was significantly high in the pterygium tissue (p<0.001), acylcarnitine levels were significantly high in some esterized derivatives (C2, C5, C5:1, C5DC, C16:1, C18, methylglutarylcarnitine) (p<0.05). No statistically significant difference was determined for the other esterized derivatives (p>0.05).
CONCLUSION
That the carnitine levels in pterygium tissue were higher suggests that acceleration of cell metabolism developed secondary to chronic inflammation and the premalignant characteristics of pterygium tissue. High carnitine levels may also effectively suppress the apoptosis process. The data reported in our study indicate that further, more extensive studies of the carnitine profile could help clarify the pathogenesis of pterygium.",2020,"While the free carnitine (C0) level was significantly high in the pterygium tissue (p<0.001), acylcarnitine levels were significantly high in some esterized derivatives (C2, C5, C5:1, C5DC, C16:1, C18, methylglutarylcarnitine) (p<0.05).","['Pterygium and normal conjunctival tissue samples from a single eye of 29 patients (16 females, 13 males; mean age, 54.75 ± 11.25 years [range, 21-78 years']",[],"['acylcarnitine levels', 'free carnitine (C0) level', 'free carnitine and acylcarnitine levels', 'carnitine levels']","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517532', 'cui_str': '11.25 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",[],"[{'cui': 'C0368608', 'cui_str': 'acylcarnitine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4040379', 'cui_str': 'Free carnitine (substance)'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}]",,0.0187213,"While the free carnitine (C0) level was significantly high in the pterygium tissue (p<0.001), acylcarnitine levels were significantly high in some esterized derivatives (C2, C5, C5:1, C5DC, C16:1, C18, methylglutarylcarnitine) (p<0.05).","[{'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Saglik', 'Affiliation': 'Department of Ophthalmology, Harran University Faculty of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Koyuncu', 'Affiliation': 'Department of Biochemistry, Harran University Faculty of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Yalcin', 'Affiliation': 'Unit of Biometry and Genetics, Harran University Faculty of Agriculture, Şanlıurfa, Turkey.'}, {'ForeName': 'Fatih Mehmet', 'Initials': 'FM', 'LastName': 'Adibelli', 'Affiliation': 'Department of Ophthalmology, Harran University Faculty of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Ataman', 'Initials': 'A', 'LastName': 'Gonel', 'Affiliation': 'Department of Biochemistry, Harran University Faculty of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Muslum', 'Initials': 'M', 'LastName': 'Toptan', 'Affiliation': 'Department of Ophthalmology, Harran University Faculty of Medicine, Şanlıurfa, Turkey.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200001']
2269,31529312,The Sunbelt Melanoma Trial.,"The Sunbelt Melanoma Trial, a multicenter, prospective randomized clinical study, evaluated the role of high-dose interferon alfa-2b (HDI) therapy for patients with a single positive sentinel lymph node (SLN) metastasis treated with a completion lymph node dissection (CLND). A second protocol in the trial evaluated the prognostic significance of using molecular markers to identify submicroscopic metastases in sentinel lymph nodes that were negative by routine pathologic analysis. The role of CLND with or without adjuvant HDI was evaluated in this group of patients. The results of the study demonstrated that adjuvant HDI offered no survival benefit for patients with a single positive SLN in terms of disease-free or overall survival. Molecular staging using polymerase chain reaction (PCR) for melanoma markers did not identify a high-risk group of patients at increased risk of melanoma recurrence. Additional treatment of these patients who were PCR-positive with either CLND alone or CLND plus HDI did not improve their survival. Additional studies from the Sunbelt Melanoma Trial helped to validate the operational standards of the SLN biopsy procedure and defined the complication rates for both SLN biopsy and CLND. A prognostic risk calculator has been developed from trial data, and the importance of different micrometastatic tumor burden measurements was reported. Although the Sunbelt Melanoma Trial did not demonstrate an improvement in survival with HDI, it is an important trial that highlights the significance of surgeon-initiated randomized clinical trials that incorporate surgical techniques, molecular biomarkers, and adjuvant therapy.",2020,Molecular staging using polymerase chain reaction (PCR) for melanoma markers did not identify a high-risk group of patients at increased risk of melanoma recurrence.,['patients with a single positive sentinel lymph node (SLN) metastasis treated with a completion lymph node dissection (CLND'],"['interferon alfa-2b (HDI) therapy', 'CLND with or without adjuvant HDI', 'CLND alone or CLND plus HDI', 'Molecular staging using polymerase chain reaction (PCR']","['disease-free or overall survival', 'survival', 'complication rates', 'survival benefit', 'survival with HDI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}]","[{'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.516918,Molecular staging using polymerase chain reaction (PCR) for melanoma markers did not identify a high-risk group of patients at increased risk of melanoma recurrence.,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Egger', 'Affiliation': 'The Hiram C Polk, Jr, MD Department of Surgery, University of Louisville School of Medicine, Louisville, KY, USA. michael.egger@louisville.edu.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Scoggins', 'Affiliation': 'The Hiram C Polk, Jr, MD Department of Surgery, University of Louisville School of Medicine, Louisville, KY, USA.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'McMasters', 'Affiliation': 'The Hiram C Polk, Jr, MD Department of Surgery, University of Louisville School of Medicine, Louisville, KY, USA.'}]",Annals of surgical oncology,['10.1245/s10434-019-07828-4']
2270,31532518,Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial.,"Importance
Parents of children with serious illness, such as cancer, experience high stress and distress. Few parent-specific psychosocial interventions have been evaluated in randomized trials.
Objective
To determine if individual- or group-based delivery of a novel intervention called Promoting Resilience in Stress Management for Parents (PRISM-P) improves parent-reported resilience compared with usual care.
Design, Setting, and Participants
This parallel, phase 2 randomized clinical trial with enrollment from December 2016 through December 2018 and 3-month follow-up was conducted at Seattle Children's Hospital. English-speaking parents or guardians of children who were 2 to 24 years old, who had received a diagnosis of a new malignant neoplasm 1 to 10 weeks prior to enrollment, and who were receiving cancer-directed therapy at Seattle Children's Hospital were included. Parents were randomized 1:1:1 to the one-on-one or group PRISM-P intervention or to usual care. Data were analyzed in 2019 (primary analyses from January to March 2019; final analyses in July 2019).
Interventions
The PRISM-P is a manualized, brief intervention targeting 4 skills: stress management, goal setting, cognitive reframing, and meaning making. For one-on-one delivery, skills were taught privately and in person for 30 to 60 minutes approximately every other week. For group delivery, the same skills were taught in a single session with at least 2 parents present.
Main Outcomes and Measures
Participants completed patient-reported outcome surveys at enrollment and at 3 months. Linear regression modeling evaluated associations in the intention-to-treat population between each delivery format and the primary outcome (Connor-Davidson Resilience Scale scores, ranging from 0 to 40, with higher scores reflecting greater resilience) and secondary outcomes (benefit finding, social support, health-related quality of life, stress, and distress) at 3 months.
Results
In total, 94 parents enrolled, were randomized to 1 of the 3 groups, and completed baseline surveys (32 parents in one-on-one sessions, 32 in group sessions, and 30 in usual care). Their median (interquartile range) ages were 35 to 38 (31-44) years across the 3 groups, and they were predominantly white, college-educated mothers. Their children had median (interquartile range) ages of 5 to 8 (3-14) years; slightly more than half of the children were boys, and the most common cancer type was leukemia or lymphoma. One-on-one PRISM-P delivery was significantly associated with improvement compared with usual care in parent-reported outcomes for resilience (β, 2.3; 95% CI, 0.1-4.6; P = .04) and for benefit finding (β, 0.5; 95% CI, 0.2-0.8; P = .001). No significant associations were detected between either platform and other parent-reported outcomes.
Conclusions and Relevance
When delivered individually, PRISM-P was associated with improved parent-reported resilience and benefit finding. This scalable psychosocial intervention may help parents cope and find meaning after their child receives a diagnosis of a serious illness.
Trial Registration
ClinicalTrials.gov identifier: NCT02998086.",2019,"One-on-one PRISM-P delivery was significantly associated with improvement compared with usual care in parent-reported outcomes for resilience (β, 2.3; 95% CI, 0.1-4.6; P = .04) and for benefit finding (β, 0.5; 95% CI, 0.2-0.8; P = .001).","['94 parents enrolled, were randomized to 1 of the 3 groups, and completed baseline surveys (32 parents in one-on-one sessions, 32 in group sessions, and 30 in usual care', 'Their median (interquartile range) ages were 35 to 38 (31-44) years across the 3 groups, and they were predominantly white, college-educated mothers', ""English-speaking parents or guardians of children who were 2 to 24 years old, who had received a diagnosis of a new malignant neoplasm 1 to 10 weeks prior to enrollment, and who were receiving cancer-directed therapy at Seattle Children's Hospital were included"", ""enrollment from December 2016 through December 2018 and 3-month follow-up was conducted at Seattle Children's Hospital"", 'Parents of Children With Cancer (PRISM-P']","['individual- or group-based delivery of a novel intervention called Promoting Resilience in Stress Management for Parents (PRISM-P', 'Stress Management Intervention', 'one or group PRISM-P intervention or to usual care']","['secondary outcomes (benefit finding, social support, health-related quality of life, stress, and distress']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0037438'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",94.0,0.115915,"One-on-one PRISM-P delivery was significantly associated with improvement compared with usual care in parent-reported outcomes for resilience (β, 2.3; 95% CI, 0.1-4.6; P = .04) and for benefit finding (β, 0.5; 95% CI, 0.2-0.8; P = .001).","[{'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Children's Core for Biomedical Statistics, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Junkins', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sherr', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kross', 'Affiliation': 'Cambia Palliative Care Center of Excellence, University of Washington, Seattle.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Cambia Palliative Care Center of Excellence, University of Washington, Seattle.'}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.11578']
2271,31532520,Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial.,"Importance
Planning complex operations such as robotic-assisted partial nephrectomy requires surgeons to review 2-dimensional computed tomography or magnetic resonance images to understand 3-dimensional (3-D), patient-specific anatomy.
Objective
To determine surgical outcomes for robotic-assisted partial nephrectomy when surgeons reviewed 3-D virtual reality (VR) models during operative planning.
Design, Setting, and Participants
A single-blind randomized clinical trial was performed. Ninety-two patients undergoing robotic-assisted partial nephrectomy performed by 1 of 11 surgeons at 6 large teaching hospitals were prospectively enrolled and randomized. Enrollment and data collection occurred from October 2017 through December 2018, and data analysis was performed from December 2018 through March 2019.
Interventions
Patients were assigned to either a control group undergoing usual preoperative planning with computed tomography and/or magnetic resonance imaging only or an intervention group where imaging was supplemented with a 3-D VR model. This model was viewed on the surgeon's smartphone in regular 3-D format and in VR using a VR headset.
Main Outcomes and Measures
The primary outcome measure was operative time. It was hypothesized that the operations performed using the 3-D VR models would have shorter operative time than those performed without the models. Secondary outcomes included clamp time, estimated blood loss, and length of hospital stay.
Results
Ninety-two patients (58 men [63%]) with a mean (SD) age of 60.9 (11.6) years were analyzed. The analysis included 48 patients randomized to the control group and 44 randomized to the intervention group. When controlling for case complexity and other covariates, patients whose surgical planning involved 3-D VR models showed differences in operative time (odds ratio [OR], 1.00; 95% CI, 0.37-2.70; estimated OR, 2.47), estimated blood loss (OR, 1.98; 95% CI, 1.04-3.78; estimated OR, 4.56), clamp time (OR, 1.60; 95% CI, 0.79-3.23; estimated OR, 11.22), and length of hospital stay (OR, 2.86; 95% CI, 1.59-5.14; estimated OR, 5.43). Estimated ORs were calculated using the parameter estimates from the generalized estimating equation model. Referent group values for each covariate and the corresponding nephrometry score were summed across the covariates and nephrometry score, and the sum was exponentiated to obtain the OR. A mean of the estimated OR weighted by sample size for each nephrometry score strata was then calculated.
Conclusions and Relevance
This large, randomized clinical trial demonstrated that patients whose surgical planning involved 3-D VR models had reduced operative time, estimated blood loss, clamp time, and length of hospital stay.
Trial Registration
ClinicalTrials.gov identifiers (1 registration per site): NCT03334344, NCT03421418, NCT03534206, NCT03542565, NCT03556943, and NCT03666104.",2019,"This large, randomized clinical trial demonstrated that patients whose surgical planning involved 3-D VR models had reduced operative time, estimated blood loss, clamp time, and length of hospital stay.
","['Ninety-two patients (58 men [63%]) with a mean (SD) age of 60.9 (11.6) years were analyzed', 'Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes', 'Ninety-two patients undergoing robotic-assisted partial nephrectomy performed by 1 of 11 surgeons at 6 large teaching hospitals', '48 patients randomized to the control group and 44 randomized to the intervention group']","['control group undergoing usual preoperative planning with computed tomography and/or magnetic resonance imaging only or an intervention group where imaging was supplemented with a 3-D VR model', '3-Dimensional Virtual Reality Models', 'robotic-assisted partial nephrectomy']","['estimated blood loss', 'clamp time', 'length of hospital stay', 'operative time', 'clamp time, estimated blood loss, and length of hospital stay', 'operative time, estimated blood loss, clamp time, and length of hospital stay']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy (procedure)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy (procedure)'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",92.0,0.171402,"This large, randomized clinical trial demonstrated that patients whose surgical planning involved 3-D VR models had reduced operative time, estimated blood loss, clamp time, and length of hospital stay.
","[{'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Shirk', 'Affiliation': 'David Geffen School of Medicine, Department of Urology, University of California, Los Angeles.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Thiel', 'Affiliation': 'Department of Urology, Mayo Clinic Florida, Jacksonville.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Wallen', 'Affiliation': 'Chapel Hill School of Medicine, Department of Urology, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Linehan', 'Affiliation': ""John Wayne Cancer Institute, Providence St John's Health Center, Santa Monica, California.""}, {'ForeName': 'Wesley M', 'Initials': 'WM', 'LastName': 'White', 'Affiliation': 'Department of Urology, The University of Tennessee Medical Center, Knoxville.'}, {'ForeName': 'Ketan K', 'Initials': 'KK', 'LastName': 'Badani', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Porter', 'Affiliation': 'Swedish Urology Group, Seattle, Washington.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11598']
2272,31434507,"Ezetimibe Lipid-Lowering Trial on Prevention of Atherosclerotic Cardiovascular Disease in 75 or Older (EWTOPIA 75): A Randomized, Controlled Trial.","BACKGROUND
Evidence regarding the primary prevention of coronary artery disease events by low-density lipoprotein cholesterol (LDL-C) lowering therapy in older individuals, aged ≥75 years, is insufficient. This trial tested whether LDL-C-lowering therapy with ezetimibe is useful for the primary prevention of cardiovascular events in older patients.
METHODS
This multicenter, prospective, randomized, open-label, blinded end-point evaluation conducted at 363 medical institutions in Japan examined the preventive efficacy of ezetimibe for patients aged ≥75 years, with elevated LDL-C without history of coronary artery disease. Patients, who all received dietary counseling, were randomly assigned (1:1) to receive ezetimibe (10 mg once daily) versus usual care with randomization stratified by site, age, sex, and baseline LDL-C. The primary outcome was a composite of sudden cardiac death, myocardial infarction, coronary revascularization, or stroke.
RESULTS
Overall, 3796 patients were enrolled between May 2009 and December 2014, and 1898 each were randomly assigned to ezetimibe versus control. Median follow-up was 4.1 years. After exclusion of 182 ezetimibe patients and 203 control patients because of lack of appropriate informed consent and other protocol violations, 1716 (90.4%) and 1695 (89.3%) patients were included in the primary analysis, respectively. Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% CI, 0.50-0.86; P =0.002). Regarding the secondary outcomes, the incidences of composite cardiac events (HR, 0.60; 95% CI, 0.37-0.98; P =0.039) and coronary revascularization (HR, 0.38; 95% CI, 0.18-0.79; P =0.007) were lower in the ezetimibe group than in the control group; however, there was no difference in the incidence of stroke, all-cause mortality, or adverse events between trial groups.
CONCLUSIONS
LDL-C-lowering therapy with ezetimibe prevented cardiovascular events, suggesting the importance of LDL-C lowering for primary prevention in individuals aged ≥75 years with elevated LDL-C. Given the open-label nature of the trial, its premature termination and issues with follow-up, the magnitude of benefit observed should be interpreted with caution. Clinical Registration: URL: https://www.umin.ac.jp. Unique identifier: UMIN000001988.",2019,"Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.50-0.86; P=0.002).","['older individuals aged ≥75 years', '363 medical institutions in Japan', '3,796 patients were enrolled between May 2009 and December 2014, and 1,898 each', '75 or Older (EWTOPIA 75', 'older patients', 'individuals aged ≥75 years with elevated LDL-C', 'patients aged ≥75 years with elevated LDL-C without history of coronary artery disease', 'https://www.umin.ac.jp Unique identifier']","['Ezetimibe', 'LDL-C-lowering therapy with ezetimibe', 'dietary counseling', 'Ezetimibe Lipid-Lowering Trial', 'ezetimibe', 'ezetimibe versus control', 'LDL-C-lowering therapy']","['coronary revascularization', 'incidences of composite cardiac events', 'incidence of stroke, all-cause mortality, or adverse events', 'cardiovascular events', 'composite of sudden cardiac death, myocardial infarction, coronary revascularization, or stroke']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",3796.0,0.28082,"Ezetimibe reduced the incidence of the primary outcome (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.50-0.86; P=0.002).","[{'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Ouchi', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan (Y. Ouchi, M.K.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sasaki', 'Affiliation': 'International University of Health and Welfare, Fukuoka, Japan (J.S.).'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'National Center for Geriatrics and Gerontology, Obu, Japan (H.A.).'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Chiba University, Chiba, Japan (K.Y.).'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan (K.H., H.I.).'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Katayama', 'Affiliation': 'General Tokyo Hospital, Tokyo, Japan (Y.K.).'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Urabe', 'Affiliation': 'Juntendo University Urayasu Hospital, Urayasu, Japan (T.U.).'}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Saga Memorial Hospital, Saga, Japan (Y.U.).'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': 'Nagahama City Hospital, Nagahama, Japan (M.H.).'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Yokota', 'Affiliation': 'Yokota Clinic, Miyazaki, Japan (N.Y.).'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nishida', 'Affiliation': 'Nishida Clinic, Neyagawa, Japan (H.N.).'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Otonari', 'Affiliation': 'Otonari Clinic, Chikushino, Japan (T.O.).'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Arai', 'Affiliation': 'Arai Clinic, Yamagata, Japan (T.A.).'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sakuma', 'Affiliation': 'Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan (I.S.).'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Sakabe', 'Affiliation': 'Sakabe Clinic, Kyoto, Japan (K.S.).'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Yamamoto Clinic, Shimoniikawa, Japan (M.Y.).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Jyuzen General Hospital, Niihama, Japan (T.K.).'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Oikawa', 'Affiliation': 'Fukujuji Hospital, Tokyo, Japan (S.O.).'}, {'ForeName': 'Shizuya', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Rinku General Medical Center, Izumisano, Japan (S.Y.).'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Osaka University, Suita, Japan (H.R.).'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Kyoto University, Japan (T.I., S.T.).'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Kyoto University, Japan (T.I., S.T.).'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Chuo University, Tokyo, Japan (Y. Osachi).'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Kuwabara', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan (Y. Ouchi, M.K.).'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan (K.H., H.I.).'}]",Circulation,['10.1161/CIRCULATIONAHA.118.039415']
2273,27788018,Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome.,"RATIONALE
After the sample size of a randomized clinical trial (RCT) is set by the power requirement of its primary endpoint, investigators select secondary endpoints while unable to further adjust sample size. How the sensitivity and specificity of an instrument used to measure these outcomes, together with their expected underlying event rates, affect an RCT's power to measure significant differences in these outcomes is poorly understood.
OBJECTIVES
Motivated by the design of an RCT of neuromuscular blockade in acute respiratory distress syndrome, we examined how power to detect a difference in secondary endpoints varies with the sensitivity and specificity of the instrument used to measure such outcomes.
METHODS
We derived a general formula and Stata code for calculating an RCT's power to detect differences in binary outcomes when such outcomes are measured with imperfect sensitivity and specificity. The formula informed the choice of instrument for measuring post-traumatic stress-like symptoms in the Reevaluation of Systemic Early Neuromuscular Blockade RCT ( www.clinicaltrials.gov identifier NCT02509078).
MEASUREMENTS AND MAIN RESULTS
On the basis of published sensitivities and specificities, the Impact of Events Scale-Revised was predicted to measure a 36% symptom rate, whereas the Post-Traumatic Stress Symptoms instrument was predicted to measure a 23% rate, if the true underlying rate of post-traumatic stress symptoms were 25%. Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity.
CONCLUSIONS
Examining instruments' power to detect differences in outcomes may guide their selection when multiple instruments exist, each with different sensitivities and specificities.",2017,"Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity.
","['acute respiratory distress syndrome', 'Subjects with Acute Respiratory Distress Syndrome']",[],[],"[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}]",[],[],,0.167258,"Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity.
","[{'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sjoding', 'Affiliation': '1 Department of Internal Medicine and.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': '3 Biostatistics Unit, Massachusetts General Hospital and Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': '4 Department of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': '5 Division of Pulmonary and Critical Care Medicine, Harborview Medical Center, University of Washington, Seattle, Washington.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': '6 Department of Emergency Medicine and.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': '7 Department of Medicine, University of Colorado, Denver, Colorado; and.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': '8 Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Iwashyna', 'Affiliation': '1 Department of Internal Medicine and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201608-585OC']
2274,30655451,Sertraline or placebo in chronic breathlessness? Lessons from placebo research.,,2019,,[],"['Sertraline or placebo', 'placebo']",[],[],"[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.21493,,"[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Pattinson', 'Affiliation': 'Nuffield Dept of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vishvarani', 'Initials': 'V', 'LastName': 'Wanigasekera', 'Affiliation': 'Nuffield Dept of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]",The European respiratory journal,['10.1183/13993003.02225-2018']
2275,30692903,Retraction: A randomized comparative study assessing efficacy of pain versus comfort scores.,"[This retracts the article on p. 396 in vol. 11, PMID: 29033718.].",2019,[This retracts the article on p. 396 in vol.,['Retraction'],[],[],"[{'cui': 'C0332523', 'cui_str': 'Retraction (finding)'}]",[],[],,0.0161005,[This retracts the article on p. 396 in vol.,[],Saudi journal of anaesthesia,['10.4103/1658-354X.248909']
2276,20668559,Low flow anesthesia: Efficacy and outcome of laryngeal mask airway versus pressure-optimized cuffed-endotracheal tube.,"BACKGROUND
Low flow anesthesia can lead to reduction of anesthetic gas and vapor consumption. Laryngeal mask airway (LMA) has proved to be an effective and safe airway device. The aim of this study is to assess the feasibility of laryngeal mask airway during controlled ventilation using low fresh gas flow (1.0 L/min) as compared to endotracheal tube (ETT).
PATIENTS AND METHODS
Fifty nine non-smoking adult patients; ASA I or II, being scheduled for elective surgical procedures, with an expected duration of anesthesia 60 minutes or more, were randomly allocated into two groups - Group I (29 patients) had been ventilated using LMA size 4 for females and 5 for males respectively; and Group II (30 patients) were intubated using ETT. After 10 minutes of high fresh gas flow, the flow was reduced to 1 L/min. Patients were monitored for airway leakage, end-tidal CO(2)(ETCO(2)), inspiratory and expiratory isoflurane and nitrous oxide fraction concentrations, and postoperative airway-related complications.
RESULTS
Two patients in the LMA-group developed initial airway leakage (6.9%) versus no patient in ETT-group. Cough and sore throat were significantly higher in ETT patients. There were no evidences of differences between both groups regarding ETCO(2), uptake of gases, nor difficulty in swallowing.
CONCLUSION
The laryngeal mask airway proved to be effective and safe in establishing an airtight seal during controlled ventilation under low fresh gas flow of 1 L/min, inducing less coughing and sore throat during the immediate postoperative period than did the ETT, with continuous measurement and readjustment of the tube cuff pressure.",2010,"There were no evidences of differences between both groups regarding ETCO(2), uptake of gases, nor difficulty in swallowing.
","['Fifty nine non-smoking adult patients; ASA I or II, being scheduled for elective surgical procedures, with an expected duration of anesthesia 60 minutes or more']","['laryngeal mask airway versus pressure-optimized cuffed-endotracheal tube', 'Laryngeal mask airway (LMA']","['initial airway leakage', 'Cough and sore throat', 'airway leakage, end-tidal CO(2)(ETCO(2)), inspiratory and expiratory isoflurane and nitrous oxide fraction concentrations, and postoperative airway-related complications', 'ETCO(2), uptake of gases, nor difficulty in swallowing']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}]",,0.0211154,"There were no evidences of differences between both groups regarding ETCO(2), uptake of gases, nor difficulty in swallowing.
","[{'ForeName': 'Zeinab A', 'Initials': 'ZA', 'LastName': 'El-Seify', 'Affiliation': 'Department of Anesthesia, Doha Clinic Hospital, Doha, Qatar.'}, {'ForeName': 'Ahmed Metwally', 'Initials': 'AM', 'LastName': 'Khattab', 'Affiliation': ''}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Shaaban', 'Affiliation': ''}, {'ForeName': 'Dobrila', 'Initials': 'D', 'LastName': 'Radojevic', 'Affiliation': ''}, {'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Jankovic', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.62607']
2277,20529525,Hand-eye dominance and depth perception effects in performance on a basic laparoscopic skills set.,"OBJECTIVES
Our study determined whether depth perception defects and hand-eye dominance affect an individual's ability to perform laparoscopic skills.
METHODS
The study cohort comprised 104 third-year medical students from LSU School of Medicine who completed a questionnaire including information on handedness and were tested for eye dominance and depth perception by using standardized methods. Training sessions involved an initial recorded performance, a 20-minute practice session, followed by a final recorded performance. Recorded sessions were randomized and rated by using a visual analog scale (maximal possible score = 16) based on overall performance (OPS) and depth perception (DPS). A general linear model was used to correlate depth perception defects and hand-eye dominance with assessment scores for OPS and DPS.
RESULTS
Students with depth perception defects scored significantly lower on their initial performance than did those with normal depth perception (OPS, 4.80 vs. 7.16, P=0.0008; DPS, 5.25 vs. 6.93, P=0.0195). After training, the depth perception defect group continued to have lower scores compared with the normal depth perception group. However, the 2 groups showed similar increases in pre- to posttraining performance scores (OPS, 3.84 vs. 3.18, P=0.0732). Hand-eye dominance did not significantly affect scores.
CONCLUSIONS
Depth perception defects appear to compromise an individual's ability to perform basic laparoscopic skills. Individuals with defects can improve their skills by a proportion comparable to that of people with uncompromised depth perception. Differences in hand-eye dominance do not correlate with performance differences in basic laparoscopic skills. Although further research is necessary, the findings indicate that training can be tailored for individuals with depth perception defects to improve laparoscopic performance.",2010,"RESULTS
Students with depth perception defects scored significantly lower on their initial performance than did those with normal depth perception (OPS, 4.80 vs. 7.16, P=0.0008; DPS, 5.25 vs. 6.93, P=0.0195).",['104 third-year medical students from LSU School of Medicine who completed a questionnaire including information on handedness and were tested for eye dominance and depth perception by using standardized methods'],[],"['pre- to posttraining performance scores', 'initial performance', 'overall performance (OPS) and depth perception (DPS']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023114', 'cui_str': 'Handedness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0422883', 'cui_str': 'Eyedness'}, {'cui': 'C0011586', 'cui_str': 'Stereopsis'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011586', 'cui_str': 'Stereopsis'}]",,0.0903902,"RESULTS
Students with depth perception defects scored significantly lower on their initial performance than did those with normal depth perception (OPS, 4.80 vs. 7.16, P=0.0008; DPS, 5.25 vs. 6.93, P=0.0195).","[{'ForeName': 'Rabiya', 'Initials': 'R', 'LastName': 'Suleman', 'Affiliation': 'Department of Obstetrics/Gynecology, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Paige', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Chauvin', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Alleyn', 'Affiliation': ''}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Brewer', 'Affiliation': ''}, {'ForeName': 'Stephen I', 'Initials': 'SI', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Hoxsey', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/108680810X12674612014428']
2278,32128848,The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomised controlled trial.,"BACKGROUND
In vivo studies show that cannabidiol (CBD) acutely reduces blood pressure (BP) in men. The aim of this study was to assess the effects of repeated CBD dosing on haemodynamics.
METHODS
Twenty-six healthy males were given CBD (600 mg) or placebo orally for seven days in a randomised, placebo-controlled, double-blind, parallel study (n = 13/group). Cardiovascular parameters were assessed at rest and in response to isometric exercise after acute and repeated dosing using Finometer®, Vicorder® and Duplex ultrasound.
RESULTS
Compared to placebo, CBD significantly reduced resting mean arterial pressure (P = .04, two-way ANOVA, mean difference (MD) -2 mmHg, 95% CI -3.6 to -0.3) after acute dosing, but not after repeated dosing. In response to stress, volunteers who had taken CBD had lower systolic BP after acute (P = .001, two-way ANOVA, MD -6 mmHg, 95% CI -10 to -1) and repeated (P = .02, two-way ANOVA, MD -5.7 mmHg, 95% CI -10 to -1) dosing. Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01). Within the CBD group, repeated dosing reduced arterial stiffness by day 7 (pulse wave velocity; MD -0.44 m/s, P = .05) and improved endothelial function (flow mediation dilatation, MD +3.5%, P = .02, n = 6 per group), compared to day 1.
CONCLUSION
CBD reduces BP at rest after a single dose but the effect is lost after seven days of treatment (tolerance); however, BP reduction during stress persists. The reduction in arterial stiffness and improvements in endothelial function after repeated CBD dosing are findings that warrant further investigation in populations with vascular diseases.",2020,"Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01).","['Twenty-six healthy males', 'healthy men', 'men']","['placebo', 'CBD', 'placebo, CBD', 'cannabidiol (CBD']","['Cardiovascular parameters', 'BP reduction', 'systolic BP', 'blood pressure (BP', 'arterial stiffness', 'resting mean arterial pressure', 'internal carotid artery diameter', 'endothelial function']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",26.0,0.459438,"Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01).","[{'ForeName': 'Salahaden R', 'Initials': 'SR', 'LastName': 'Sultan', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Saoirse E', 'Initials': 'SE', 'LastName': ""O'Sullivan"", 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}]",British journal of clinical pharmacology,['10.1111/bcp.14225']
2279,20532105,Sevoflurane-emergence agitation: Effect of supplementary low-dose oral ketamine premedication in preschool children undergoing dental surgery.,"BACKGROUND AND OBJECTIVES
The use of sevoflurane in pediatric anesthesia, which could enable a more rapid emergence and recovery, is complicated by the frequent occurrence of post-anesthesia agitation. This study aims to test the efficacy of adding a low dose of ketamine orally, as a supplement to the midazolam-based oral premedication for reducing sevoflurane-related emergence agitation.
MATERIALS AND METHODS
Ninety-two preschool children, aged between two and six years, with an American Society of Anesthesiologists physical status I or II, scheduled for elective dental filling and extractions under general anesthesia were included. The patients were allocated into two groups: Group M (46 patients) received oral midazolam 0.5 mg/kg, mixed with ibuprofen 10 mg/kg, while group KM (46 patients) received a similar premedication mixture, in addition to ketamine 2 mg/kg. The acceptance of the drug mixture, the onset of action, and the occurrence of vomiting were monitored over the next 30 minutes. Induction of anesthesia was carried out using sevoflurane 8 Vol% in 100% oxygen via face mask. Anesthesia was maintained with sevoflurane 1.5-2 Vol% in an oxygen-nitrous oxide mixture. After extubation, the standard scoring scale was used for assessing the quality of emergence. Agitation parameters were measured using a five-point scale. Agitated children were managed by giving intravenous increments of fentanyl 1 mug/ kg. The time of hospital discharge allowance was recorded.
RESULTS
Drug palatability, vomiting, and onset of action of premedication; showed no significant differences between both groups. Time of eye opening after discontinuation of sevoflurane showed no significant differences between both groups. Postoperative agitation score and rescue fentanyl consumption were higher in group M than in group KM on admission to the PACU (P < 0.01). The time of hospital discharge allowance in group M was longer than in group KM (P < 0.05).
CONCLUSION
Adding a low dose of oral ketamine to midazolam-based oral premedication in preschool children undergoing dental surgery reduced sevoflurane-related emergence agitation without delaying discharge.",2009,Postoperative agitation score and rescue fentanyl consumption were higher in group M than in group KM on admission to the PACU (P < 0.01).,"['preschool children undergoing dental surgery', 'preschool children undergoing dental surgery reduced sevoflurane-related emergence agitation without delaying discharge', 'Ninety-two preschool children, aged between two and six years, with an American Society of Anesthesiologists', 'physical status I or II, scheduled for elective dental filling and extractions under general anesthesia were included']","['supplementary low-dose oral ketamine premedication', 'sevoflurane 1.5-2 Vol% in an oxygen-nitrous oxide mixture', 'midazolam-based oral premedication', 'Sevoflurane', 'sevoflurane', 'ketamine', 'oral midazolam 0.5 mg/kg, mixed with ibuprofen 10 mg/kg, while group KM (46 patients) received a similar premedication mixture, in addition to ketamine 2 mg/kg']","['Time of eye opening', 'occurrence of vomiting', 'Agitation parameters', 'Postoperative agitation score and rescue fentanyl consumption', 'time of hospital discharge allowance', 'Drug palatability, vomiting, and onset of action of premedication']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0178866'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}]",92.0,0.163303,Postoperative agitation score and rescue fentanyl consumption were higher in group M than in group KM on admission to the PACU (P < 0.01).,"[{'ForeName': 'Ahmed Metwally', 'Initials': 'AM', 'LastName': 'Khattab', 'Affiliation': 'Ain Shams University, Cairo, Egypt, Doha Clinic Hospital, Department of Anesthesia, Doha, Qatar.'}, {'ForeName': 'Zeinab Ahmed', 'Initials': 'ZA', 'LastName': 'El-Seify', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.57878']
2280,32430334,Polygenic risk for skin autoimmunity impacts immune checkpoint blockade in bladder cancer.,"PD-1 and PD-L1 act to restrict T cell responses in cancer and contribute to self-tolerance. Consistent with this role, PD-1 checkpoint inhibitors have been associated with immune-related adverse events (irAEs), immune toxicities thought to be autoimmune in origin. Analyses of dermatological irAEs have identified an association with improved overall survival (OS) following anti-PD-(L)1 therapy, but the factors that contribute to this relationship are poorly understood. We collected germline whole-genome sequencing data from IMvigor211, a recent phase 3 randomized controlled trial comparing atezolizumab (anti-PD-L1) monotherapy to chemotherapy in bladder cancer. We found that high vitiligo, high psoriasis, and low atopic dermatitis polygenic risk scores (PRSs) were associated with longer OS under anti-PD-L1 monotherapy as compared to chemotherapy, reflecting the Th17 polarization of these diseases. PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures. Shared genetic factors impact risk for dermatological autoimmunity and anti-PD-L1 monotherapy in bladder cancer.",2020,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.",['bladder cancer'],['atezolizumab (anti-PD-L1) monotherapy'],"['overall survival (OS', 'low atopic dermatitis polygenic risk scores (PRSs']","[{'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0526833,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.","[{'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Di Nucci', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Kwan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hammer', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rouilly', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Fontes', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Ley Acosta', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Guardino', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Haiyin', 'Initials': 'H', 'LastName': 'Chen-Harris', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Bhangale', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Mellman', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, EC1M 6BQ London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hunkapiller', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Chandler', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Albert', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1922867117']
2281,31163332,Feasibility and acceptability of integrated psychological therapy versus treatment as usual for people with bipolar disorder and co-morbid alcohol use: A single blind randomised controlled trial.,"BACKGROUND
Alcohol use is a common problem in bipolar disorder (BD) and evidence indicates more promising outcomes for alcohol use than other substances. No trials have evaluated individual integrated motivational interviewing and cognitive behaviour therapy (MI-CBT) for problematic alcohol use in BD. We therefore assessed the feasibility and acceptability of a novel MI-CBT intervention for alcohol use in BD.
METHODS
A single blind RCT was conducted to compare MI-CBT plus treatment as usual (TAU) with TAU only. MI-CBT was delivered over 20 sessions with participants followed up at 3, 6, 9 and 12 months post-randomisation. Primary outcomes were the feasibility and acceptability of MI-CBT (recruitment to target, retention to follow-up and therapy, acceptability of therapy and absence of adverse events). We also conducted preliminary analyses of alcohol and mood outcomes (frequency and severity of alcohol use and time to mood relapse).
RESULTS
44 participants were recruited with 75% retention to 6 and 12 months follow-up. Therapy participants attended a mean of 17.6 (SD 4.5) sessions. Therapy alliance and treatment fidelity were acceptable. Qualitative interviews indicated the intervention was experienced as collaborative, and helpful, in addressing mood and alcohol issues, although risk of overconfidence following therapy was also identified. Clinical outcomes did not differ between arms at 12 months follow-up.
LIMITATIONS
As a feasibility and acceptability trial any secondary results should be treated with caution.
CONCLUSIONS
Integrated MI-CBT is feasible and acceptable, but lack of clinical impact, albeit in a feasibility study, suggests need for further development. Potential adaptations are discussed.",2019,No trials have evaluated individual integrated motivational interviewing and cognitive behaviour therapy (MI-CBT) for problematic alcohol use in BD.,"['people with bipolar disorder and co-morbid alcohol use', '44 participants were recruited with 75% retention to 6 and 12 months follow-up']","['novel MI-CBT intervention', 'integrated psychological therapy', 'individual integrated motivational interviewing and cognitive behaviour therapy (MI-CBT']","['Feasibility and acceptability', 'alcohol and mood outcomes (frequency and severity of alcohol use and time to mood relapse', 'feasibility and acceptability of MI-CBT (recruitment to target, retention to follow-up and therapy, acceptability of therapy and absence of adverse events']","[{'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.0566174,No trials have evaluated individual integrated motivational interviewing and cognitive behaviour therapy (MI-CBT) for problematic alcohol use in BD.,"[{'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Medicine, Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, Lancashire UK. Electronic address: s.jones7@lancaster.ac.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Riste', 'Affiliation': 'Faculty of Biology, Medicine and Health, Centre for Primary Care, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Faculty of Health and Medicine, Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, Lancashire UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Holland', 'Affiliation': 'Faculty of Biology, Medicine and Health, Institute of Population Health, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Psychology and Mental Health, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Rosalyn', 'Initials': 'R', 'LastName': 'Hartwell', 'Affiliation': 'Greater Manchester Mental Health NHS Foundation Trust, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Berry', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Psychology and Mental Health, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Fitzsimmons', 'Affiliation': 'Lancashire Care NHS Foundation Trust, Preston, Lancashire, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Wilson', 'Affiliation': 'Greater Manchester Mental Health NHS Foundation Trust, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hilton', 'Affiliation': 'Faculty of Health and Medicine, Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, Lancashire UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Long', 'Affiliation': 'Faculty of Health and Medicine, Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, Lancashire UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bateman', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Psychology and Mental Health, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Weymouth', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Psychology and Mental Health, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Psychology and Mental Health, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Faculty of Biology, Medicine and Health, Institute of Population Health, University of Manchester, Manchester, Greater Manchester, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Barrowclough', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Psychology and Mental Health, University of Manchester, Manchester, Greater Manchester, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2019.05.038']
2282,20298924,B-type natriuretic peptide and the effect of ranolazine in patients with non-ST-segment elevation acute coronary syndromes: observations from the MERLIN-TIMI 36 (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary-Thrombolysis In Myocardial Infarction 36) trial.,"OBJECTIVES
We designed a prospective evaluation of the interaction between B-type natriuretic peptide (BNP) and the effect of ranolazine in patients with acute coronary syndromes (ACS) as part of a randomized, blinded, placebo-controlled trial.
BACKGROUND
Ranolazine is believed to exert anti-ischemic effects by reducing myocardial sodium and calcium overload and consequently ventricular wall stress. BNP increases in response to increased wall stress and is a strong risk indicator in ACS.
METHODS
We measured plasma BNP in all available baseline samples (n = 4,543) among patients with non-ST-segment elevation ACS randomized to ranolazine or placebo in the MERLIN-TIMI 36 (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary-Thrombolysis In Myocardial Infarction 36) trial and followed them for a mean of 343 days. The primary end point was a composite of cardiovascular death, myocardial infarction, and recurrent ischemia. BNP elevation was defined as >80 pg/ml.
RESULTS
Patients with elevated BNP (n = 1,935) were at significantly higher risk of the primary trial end point (26.4% vs. 20.4%, p < 0.0001), cardiovascular death (8.0% vs. 2.1%, p < 0.001), and myocardial infarction (10.6% vs. 5.8%, p < 0.001) at 1 year. In patients with BNP >80 pg/ml, ranolazine reduced the primary end point (hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.66 to 0.94, p = 0.009). The effect of ranolazine in patients with BNP >80 pg/ml was directionally similar for recurrent ischemia (HR: 0.78; 95% CI: 0.62 to 0.98; p = 0.04) and cardiovascular death or myocardial infarction (HR: 0.83; 95% CI: 0.66 to 1.05, p = 0.12). There was no detectable effect in those with low BNP (p interaction value = 0.05).
CONCLUSIONS
Our findings indicate that ranolazine may have enhanced efficacy in high-risk patients with ACS identified by increased BNP. The interaction of biomarkers of hemodynamic stress and the effects of ranolazine warrants additional investigation. (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes; NCT00099788).",2010,"In patients with BNP >80 pg/ml, ranolazine reduced the primary end point (hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.66 to 0.94, p = 0.009).","['patients with acute coronary syndromes (ACS', 'patients with BNP >80 pg/ml', 'Non-ST Elevation Acute Coronary-Thrombolysis', 'patients with non-ST-segment elevation acute coronary syndromes', 'in all available baseline samples (n = 4,543) among patients with non-ST-segment elevation ACS randomized to', 'Non-ST Elevation Acute Coronary Syndromes', 'for Less Ischemia in Non-ST Elevation Acute Coronary-Thrombolysis']","['placebo', 'ranolazine', 'Ranolazine', 'B-type natriuretic peptide (BNP', 'ranolazine or placebo']","['recurrent ischemia', 'cardiovascular death or myocardial infarction', 'composite of cardiovascular death, myocardial infarction, and recurrent ischemia', 'myocardial infarction', 'plasma BNP', 'cardiovascular death', 'BNP elevation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073633', 'cui_str': 'ranolazine'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",1935.0,0.0899025,"In patients with BNP >80 pg/ml, ranolazine reduced the primary end point (hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.66 to 0.94, p = 0.009).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: dmorrow@partners.org.""}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'de Lemos', 'Affiliation': 'University of Texas Southwestern Medical School, Dallas, Texas.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Theroux', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Medizinische Universitatsklinik, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2009.09.068']
2283,30946156,Cardiorespiratory fitness is associated with inflammation and physical activity in HIV+ adults.,"OBJECTIVE
Our objective was to examine the effect of a lifestyle diet and exercise intervention on cardiorespiratory fitness (CRF) and to examine predictors of change in CRF.
DESIGN
People living with HIV (PLHIV) are at increased risk for cardiovascular disease. CRF is a better predictor of cardiovascular disease-related mortality than established risk factors yet very little is known about CRF in PLHIV.
METHODS
One-hundred and seven virally suppressed PLHIV were randomized to a group-based intervention to improve lifestyle behaviors or a control condition. All PLHIV maximal cardiorespiratory stress test to determine VO2 peak, VO2 at anaerobic threshold, and ventilatory efficiency/VCO2, at baseline and 6 months later. Participants wore an accelerometer to measure physical activity, completed waist-hip circumference measures, and had a fasting lipid profile, IL-6, and high sensitivity C-reactive protein analyzed. Generalized estimating equations were used to examine the effect of the intervention on CRF and predictors of change in CRF.
RESULTS
Participants were approximately 53 years old, 65% male (n = 70), and 86% African-American (n = 93). There was no effect of the intervention on markers of CRF over time (P > 0.05). After controlling for age, sex, waist-hip-ratio, the inflammatory biomarker IL-6 was inversely associated with a decline in both VO2 peak (P = 0.03) and VO2 at anaerobic threshold (P = 0.03). In addition, participants who walked an additional 10 000 steps per day had a 2.69 ml/kg per min higher VO2 peak (P = 0.02).
CONCLUSION
Despite HIV viral suppression, PLHIV had remarkably poor CRF and inflammation was associated with a clinically adverse CRF profile. However, increased physical activity was associated with improved CRF.",2019,There was no effect of the intervention on markers of CRF over time (P > 0.05).,"['People living with HIV (PLHIV', 'HIV+ adults', 'Participants were approximately 53 years old, 65% male (n\u200a=\u200a70), and 86% African-American (n\u200a=\u200a93', 'One-hundred and seven virally suppressed PLHIV']","['CRF', 'lifestyle diet and exercise intervention', 'group-based intervention to improve lifestyle behaviors or a control condition']","['VO2 peak', 'markers of CRF over time', 'cardiorespiratory fitness (CRF', 'VO2 peak, VO2 at anaerobic threshold, and ventilatory efficiency/VCO2', 'HIV viral suppression', 'physical activity', 'CRF and inflammation']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",107.0,0.057033,There was no effect of the intervention on markers of CRF over time (P > 0.05).,"[{'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Webel', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vest', 'Affiliation': 'University Hospitals Harrington Heart and Vascular Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Vitor H F', 'Initials': 'VHF', 'LastName': 'Oliveira', 'Affiliation': 'Department of Exercise Physiology, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Chris T', 'Initials': 'CT', 'LastName': 'Longenecker', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine.'}, {'ForeName': 'Jintao', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Currie', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Josephson', 'Affiliation': 'Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002154']
2284,20206456,Efficacy of rosuvastatin among men and women with moderate chronic kidney disease and elevated high-sensitivity C-reactive protein: a secondary analysis from the JUPITER (Justification for the Use of Statins in Prevention-an Intervention Trial Evaluating Rosuvastatin) trial.,"OBJECTIVES
We evaluated the efficacy of statin therapy in primary prevention among individuals with moderate chronic kidney disease (CKD).
BACKGROUND
Whether patents with moderate CKD (estimated glomerular filtration rate [eGFR] <60 ml/min/1.73 m(2)) benefit from statin therapy is uncertain, particularly among those without hyperlipidemia or known cardiovascular disease.
METHODS
Within the JUPITER (Justification for the Use of statins in Prevention-an Intervention Trial Evaluating Rosuvastatin) primary prevention trial of rosuvastatin 20 mg compared with placebo among men and women free of cardiovascular disease who had low-density lipoprotein cholesterol (LDL-C) <130 mg/dl and high-sensitivity C-reactive protein (hsCRP) >or=2 mg/l, we performed a secondary analysis comparing cardiovascular and mortality outcomes among those with moderate CKD at study entry (n = 3,267) with those with baseline eGFR >or=60 ml/min/1.73 m(2) (n = 14,528). Median follow-up was 1.9 years (maximum 5 years).
RESULTS
Compared with those with eGFR >or=60 ml/min/1.73 m(2), JUPITER participants with moderate CKD had higher vascular event rates (hazard ratio [HR]: 1.54, 95% confidence interval [CI]: 1.23 to 1.92, p = 0.0002). Among those with moderate CKD, rosuvastatin was associated with a 45% reduction in risk of myocardial infarction, stroke, hospital stay for unstable angina, arterial revascularization, or confirmed cardiovascular death (HR: 0.55, 95% CI: 0.38 to 0.82, p = 0.002) and a 44% reduction in all-cause mortality (HR: 0.56, 95% CI: 0.37 to 0.85, p = 0.005). Median LDL-C and hsCRP reductions as well as side effect profiles associated with rosuvastatin were similar among those with and without CKD. Median eGFR at 12 months was marginally improved among those allocated to rosuvastatin as compared with placebo.
CONCLUSIONS
Rosuvastatin reduces first cardiovascular events and all-cause mortality among men and women with LDL-C <130 mg/dl, elevated hsCRP, and concomitant evidence of moderate CKD. (JUPITER-Crestor 20 mg Versus Placebo in Prevention of Cardiovascular [CV] Events; NCT00239681).",2010,"Among those with moderate CKD, rosuvastatin was associated with a 45% reduction in risk of myocardial infarction, stroke, hospital stay for unstable angina, arterial revascularization, or confirmed cardiovascular death (HR: 0.55, 95% CI: 0.38 to 0.82, p = 0.002) and a 44% reduction in all-cause mortality (HR: 0.56, 95% CI: 0.37 to 0.85, p = 0.005).","['men and women free of cardiovascular disease who had low-density lipoprotein cholesterol (LDL-C) <130 mg/dl and high-sensitivity C-reactive protein (hsCRP', 'men and women with moderate chronic kidney disease and elevated high-sensitivity C-reactive protein', 'or=60 ml/min/1.73 m(2', 'Cardiovascular [CV', 'individuals with moderate chronic kidney disease (CKD', 'those with moderate CKD at study entry (n = 3,267) with those with baseline eGFR ']","['rosuvastatin', 'placebo', 'JUPITER', 'Placebo', 'statin therapy', 'Rosuvastatin']","['Median eGFR', 'risk of myocardial infarction, stroke, hospital stay for unstable angina, arterial revascularization, or confirmed cardiovascular death', 'vascular event rates', 'Median LDL-C and hsCRP reductions']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242754', 'cui_str': 'Jupiter'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",3267.0,0.106353,"Among those with moderate CKD, rosuvastatin was associated with a 45% reduction in risk of myocardial infarction, stroke, hospital stay for unstable angina, arterial revascularization, or confirmed cardiovascular death (HR: 0.55, 95% CI: 0.38 to 0.82, p = 0.002) and a 44% reduction in all-cause mortality (HR: 0.56, 95% CI: 0.37 to 0.85, p = 0.005).","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: pridker@partners.org.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cressman', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2010.01.020']
2285,31589269,Studies Making Use of the Same Randomized Clinical Trial Cohorts-Reply.,,2019,,[],[],[],[],[],[],,0.1002,,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Newtown, New South Wales, Australia.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.4624']
2286,31589263,Studies Making Use of the Same Randomized Clinical Trial Cohorts.,,2019,,[],[],[],[],[],[],,0.112045,,"[{'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Basic Medical College, Department of Biochemistry and Molecular Biology, Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Yunni', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Basic Medical College, Department of Biochemistry and Molecular Biology, Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Shanggui', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Basic Medical College, Department of Biochemistry and Molecular Biology, Guangxi Medical University, Nanning, Guangxi, China.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.4621']
2287,31364501,Pump controlled retrograde trial off using the Cardiohelp console: safety considerations.,,2019,,[],[],[],[],[],[],,0.0665031,,"[{'ForeName': 'Adrian C', 'Initials': 'AC', 'LastName': 'Mattke', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Haisz', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Black', 'Affiliation': ""Paediatric Critical Care Research Group, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Venugopal', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}]",Perfusion,['10.1177/0267659119865827']
2288,20532102,Effect of fluid preloading on postoperative nausea and vomiting following laparoscopic cholecystectomy.,"BACKGROUND
Postoperative nausea and vomiting (PONV) is a common complication following general anesthesia. Different regimens have been described for the treatment of PONV with few that mention the prevention of it. Therefore, we conducted this study to compare the effect of preloading with either crystalloids or colloids on the incidence of PONV following laparoscopic cholecystectomy (LC), under general anesthesia.
MATERIALS AND METHODS
This study was carried out on 80 patients who underwent LC. The patients were divided into four groups (each 20 patients), to receive preloading of intravenous fluid, as follows: Group 1 received, 10 ml/kg of low-MW tetrastarch in saline (Voluven), group 2 received, 10 ml/kg medium-MW pentastarch in saline (Pentaspan), group 3, received 10 ml/kg of high-MW heta-starch in saline (Hespan), and group 4, received 10 ml/kg Lactated Ringer's, and this was considered as the control group. All patients received the standard anesthetic technique. The incidence of PONV was recorded, two and 24 hours following surgery. The need for antiemetics and/or analgesics was recorded postoperatively.
RESULTS
The highest incidence of PONV was in group 3 (75% of the patients) compared to the other three groups. Also the same trend was found with regard to the number of patients who needed antiemetic therapy. It was the highest incidence in group 3 (70%), followed by group 2 (60%), and then group 1(35%), and the least one was in the control group (25%).
CONCLUSION
Intravascular volume deficits may be a factor in PONV and preloading with crystalloids showed a lower incidence of PONV.",2009,The highest incidence of PONV was in group 3 (75% of the patients) compared to the other three groups.,"['laparoscopic cholecystectomy', '80 patients who underwent LC']","['crystalloids or colloids', ""10 ml/kg of low-MW tetrastarch in saline (Voluven), group 2 received, 10 ml/kg medium-MW pentastarch in saline (Pentaspan), group 3, received 10 ml/kg of high-MW heta-starch in saline (Hespan), and group 4, received 10 ml/kg Lactated Ringer's"", 'laparoscopic cholecystectomy (LC', 'fluid preloading', 'standard anesthetic technique']","['incidence of PONV', 'highest incidence of PONV', 'postoperative nausea and vomiting']","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1816356', 'cui_str': 'Product containing tetrastarch'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C2350383', 'cui_str': 'Pentastarch'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",80.0,0.085617,The highest incidence of PONV was in group 3 (75% of the patients) compared to the other three groups.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Turkistani', 'Affiliation': 'Department of Anesthesia, College of Medicine, King Saud University, Kingdom of Saudi Arabia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Abdullah', 'Affiliation': ''}, {'ForeName': 'Essam', 'Initials': 'E', 'LastName': 'Manaa', 'Affiliation': ''}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Delvi', 'Affiliation': ''}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Khairy', 'Affiliation': ''}, {'ForeName': 'Badiah', 'Initials': 'B', 'LastName': 'Abdulghani', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Khalil', 'Affiliation': ''}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Damas', 'Affiliation': ''}, {'ForeName': 'Abdelazeem', 'Initials': 'A', 'LastName': 'El-Dawlatly', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.57872']
2289,20532103,Pre-incisional infiltration of tonsils with dexamethasone dose not reduce posttonsillectomy vomiting and pain in children.,"BACKGROUND AND OBJECTIVE
Recently, dexamethasone has been found to have a prophylactic effect on postoperative vomiting and pain in children undergoing tonsillectomy. However, few studies have examined the preemptive analgesic effects of dexamethasone after tonsillectomy. The aim of this study was to evaluate the effect of pre-incisional infiltration of tonsils with dexamethasone on the incidence and severity of postoperative pain and vomiting in children undergoing tonsillectomy under general anesthesia.
MATERIALS AND METHODS
In a double blinded study, 62 patients were randomly allocated to infiltrate dexamethasone (0.5 mg/kg, maximum dose, 12 mg) or an equivalent volume of saline at the peritonsillar region. All infiltrations were performed following the induction of general anesthesia and 5 minutes prior to the onset of surgery. Anesthetic agents, end-tidal carbon dioxide levels, and the administration of intravenous fluids were carefully regulated. Surgery was performed by one attending otolaryngologists using the same dissection and snare technique. The incidence of pain and vomiting, need for rescue antiemetics, and analgesic consumption were compared in both groups. Pain scores used included Children's Hospital Eastern Ontario Pain Scale, ""faces"", and a 0-10 visual analogue pain scale.
RESULTS
Demographics of dexamethasone and placebo groups were similar. No statistically significant difference was found between the dexamethasone and placebo groups in pain score, nausea, vomiting, irritability, or analgesic requirement postoperatively.
CONCLUSION
Preincisional infiltration of the tonsils with dexamethasone play a limited role in the recovery phase from tonsillectomy, but further prospective, randomized studies are needed to support it.",2009,"No statistically significant difference was found between the dexamethasone and placebo groups in pain score, nausea, vomiting, irritability, or analgesic requirement postoperatively.
","['children undergoing tonsillectomy under general anesthesia', 'children undergoing tonsillectomy', '62 patients', 'children']","['placebo', 'infiltrate dexamethasone', 'dexamethasone and placebo', 'dexamethasone']","['Pain scores used included Children\'s Hospital Eastern Ontario Pain Scale, ""faces"", and a 0-10 visual analogue pain scale', 'pain and vomiting, need for rescue antiemetics, and analgesic consumption', 'pain score, nausea, vomiting, irritability, or analgesic requirement postoperatively', 'postoperative pain and vomiting', 'postoperative vomiting and pain', 'posttonsillectomy vomiting and pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0042815', 'cui_str': 'Visual Analog Pain Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0520905', 'cui_str': 'Postoperative Emesis'}]",62.0,0.247358,"No statistically significant difference was found between the dexamethasone and placebo groups in pain score, nausea, vomiting, irritability, or analgesic requirement postoperatively.
","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Montazeri', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Isfahan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Okhovat', 'Affiliation': ''}, {'ForeName': 'Azim', 'Initials': 'A', 'LastName': 'Honarmand', 'Affiliation': ''}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Safavi', 'Affiliation': ''}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ashrafy', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.57874']
2290,20532104,Preoperative oral dextromethorphan does not reduce pain or morphine consumption after open cholecystectomy.,"BACKGROUND
Dextromethorphan, the D-isomer of the codeine analog levorphanol, is a weak, noncompetitive N-Methyl-D-Aspartate (NMDA) receptor antagonist. It has been suggested that NMDA receptor antagonists induce preemptive analgesia when administered before tissue injury occurs, thus decreasing the subsequent sensation of pain.
MATERIALS AND METHODS
The study was conducted in the Dr. Ali Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran, between February 2005 and December 2006. In this study, 72 patients scheduled for elective cholesyctectomy were randomized into three groups to receive either oral dextromethorphan 45 mg (Group D45 = 24), dextromethorphan 90 mg (Group D90 = 24), or placebo (Group C, n = 24), as premedication, 120 minutes before surgery. A visual analog scale (VAS) for pain of each patient was measured at arrival in the ward and six and 24 hours after surgery.
RESULTS
The demographic characteristics of patients, ASA physical status class, duration of surgery, and the basal VAS pain score were similar in the two groups. There was no significant difference in the mean of the VAS pain scores measured over time or morphine consumption among the three groups.
CONCLUSION
Dextromethorphan 45 mg and 90 mg, administrated orally, two hours before surgery, had no effect on postoperative morphine requirement and pain intensity.",2009,"There was no significant difference in the mean of the VAS pain scores measured over time or morphine consumption among the three groups.
","['Dr. Ali Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran, between February 2005 and December 2006', '72 patients scheduled for elective cholesyctectomy']","['Dextromethorphan', 'dextromethorphan', 'oral dextromethorphan', 'placebo']","['postoperative morphine requirement and pain intensity', 'ASA physical status class, duration of surgery, and the basal VAS pain score', 'pain or morphine consumption', 'VAS pain scores', 'A visual analog scale (VAS) for pain of each patient']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",72.0,0.0384301,"There was no significant difference in the mean of the VAS pain scores measured over time or morphine consumption among the three groups.
","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Mahmoodzadeh', 'Affiliation': 'Department of Surgery, Dr. Ali Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Movafegh', 'Affiliation': ''}, {'ForeName': 'Noshin Mosavi', 'Initials': 'NM', 'LastName': 'Beigi', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.57876']
2291,31170620,Internet-delivered treatment for young adults with anxiety and depression: Evaluation in routine clinical care and comparison with research trial outcomes.,"INTRODUCTION
Mood and anxiety disorders typically emerge in adolescence and early adult life, but young adults are often reluctant to seek treatment. The Mood Mechanic course is a transdiagnostic internet-delivered psychological intervention for symptoms of depression and anxiety, targeted at people aged 18-24 years. The current study compared the efficacy of the course when delivered under strict research trial conditions (research trial; n = 192) with its effectiveness in a routine health-care setting (routine care; n = 222).
METHODS
Symptoms of depression, anxiety and general distress at baseline, during, and after treatment were measured by the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), and Kessler 10-Item Scale (K-10), respectively.
RESULTS
Both groups showed significant symptom reductions on all measures at post-treatment and 3-month follow-up. Deterioration rates were low, within-group effect sizes were large (>1.0) and both groups reported high levels of treatment satisfaction. Patients in routine care were less likely to complete post-treatment or follow-up symptom questionnaires.
LIMITATIONS
The study is based on self-reported data from treatment-seeking individuals that were motivated enough to start the course, and the absence of a control group and a formal diagnosis in the routine care sample means that some caution is needed in generalising the results.
CONCLUSION
The results show that the Mood Mechanic course is effective and acceptable in routine clinical care, and that online psychological interventions designed for young adults are an effective treatment option for this hard-to-reach group.",2019,Both groups showed significant symptom reductions on all measures at post-treatment and 3-month follow-up.,"['young adults with anxiety and depression', 'young adults']","['transdiagnostic internet-delivered psychological intervention', 'routine health-care setting (routine care; n\u202f=\u202f222']","['Deterioration rates', 'Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), and Kessler 10-Item Scale (K-10), respectively', 'depression, anxiety and general distress']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0398951,Both groups showed significant symptom reductions on all measures at post-treatment and 3-month follow-up.,"[{'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Staples', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia. Electronic address: lauren.staples@mq.edu.au.'}, {'ForeName': 'Blake F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Bareena', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fogliati', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Gandy', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Fogliati', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Nielssen', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Nickolai', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2019.05.058']
2292,31843817,Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management to empower adolescents with arthritis in Ireland: protocol for a pilot randomised controlled trial.,"INTRODUCTION
Juvenile idiopathic arthritis (JIA) negatively affects adolescents' everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking Charge (TTC) and integrated it with Skype-based peer support iPeer2Peer (iP2P).
OBJECTIVES
To explore the feasibility and preliminary outcome impact (effectiveness) of an integrated iP2P and Irish TTC, via three-arm (treatment as usual, TTC and iP2P-TTC) pilot randomised controlled trial (RCT); and determine feasibility and sample size for a full RCT. To ensure active involvement of adolescents with JIA via a Young Person Advisory Panel and examine how participants experienced the study. Finally, to see if TTC and iP2P with TTC reduce costs for families.
METHODS AND ANALYSIS
Recruitment of 60 families will be ongoing until July 2019, via healthcare professionals and support groups. Analysis will consist of single-blinded (outcome assessment), three-arm pilot RCT, using online questionnaires, with assessments at baseline (T1), after intervention (T2) and 3 months post-intervention (T3). The primary outcomes on feasibility with comparisons of TTC and iP2P-TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring. The secondary outcomes will be self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs.Participants from the intervention groups will be invited to share their perspectives on the process in semistructured interviews. Quantitative data will be analysed using SPSS V.21 and the audio-taped and transcribed qualitative data will be analysed using qualitative content analysis.
DISSEMINATION
Via journal articles, conference presentations, co-delivered by key stakeholders when possible, launch of accessible, effective and sustainable Internet self-management and peer support for Irish adolescents with JIA.
TRIAL REGISTRATION NUMBER
ISRCTN13535901; Pre-results.",2019,"The primary outcomes on feasibility with comparisons of TTC and iP2P-TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring.","['Irish adolescents with JIA', '60 families will be ongoing until July 2019, via healthcare professionals and support groups', 'adolescents with arthritis in Ireland']","['integrated iP2P and Irish TTC', 'Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management']","['self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs', 'feasibility with comparisons of TTC and iP2P-TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring']","[{'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}]","[{'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",60.0,0.171361,"The primary outcomes on feasibility with comparisons of TTC and iP2P-TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring.","[{'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': ""O'Higgins"", 'Affiliation': 'Centre for Pain Research, School of Psychology, National University of Ireland, Galway, Galway, Ireland siobhan.ohiggins@nuigalway.ie.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ahola Kohut', 'Affiliation': 'Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Caes', 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, Stirling, Scotland, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Heary', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'McGuire', 'Affiliation': 'Centre for Pain Research, School of Psychology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-027952']
2293,32429917,Reducing cardiometabolic risk in adults with a low socioeconomic position: protocol of the Supreme Nudge parallel cluster-randomised controlled supermarket trial.,"BACKGROUND
Unhealthy lifestyle behaviours such as unhealthy dietary intake and insufficient physical activity (PA) tend to cluster in adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk. Educational approaches aiming to improve lifestyle behaviours show limited effect in this population. Using environmental and context-specific interventions may create opportunities for sustainable behaviour change. In this study protocol, we describe the design of a real-life supermarket trial combining nudging, pricing and a mobile PA app with the aim to improve lifestyle behaviours and lower cardiometabolic disease risk in adults with a low SEP.
METHODS
The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i) control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods). In collaboration with a Dutch supermarket chain we will select nine stores located in low SEP neighbourhoods, with the nearest competitor store at > 1 km distance and managed by a committed store manager. Across the clusters, a personalized mobile coaching app targeting walking behaviour will be randomised at the individual level, with: i) control group; ii) a group receiving the mobile PA app. All participants (target n = 1485) should be Dutch-speaking, aged 45-75 years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets. Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods. Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up. Secondary outcomes are changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction after 12 months follow-up. The trial will be reflexively monitored to support current and future implementation.
DISCUSSION
The findings can guide future research and public health policies on reducing lifestyle-related health inequalities, and contribute to a supermarket-based health promotion intervention implementation roadmap.
TRIAL REGISTRATION
Dutch Trial Register ID NL7064, 30th of May, 2018.",2020,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","['adults with a low socioeconomic position', 'The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i', 'adults with a low SEP', 'All participants (target n\xa0=\u20091485) should be Dutch-speaking, aged 45-75\u2009years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets', 'Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods', 'adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk']","['control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods']","['changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake', 'changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction', 'cardiometabolic risk', 'lifestyle behaviours']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0039371', 'cui_str': 'Tax'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009827', 'cui_str': 'Consumer Satisfaction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",,0.122374,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","[{'ForeName': 'Josine M', 'Initials': 'JM', 'LastName': 'Stuber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands. j.stuber@amsterdamumc.nl.'}, {'ForeName': 'Joreintje D', 'Initials': 'JD', 'LastName': 'Mackenbach', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Femke E', 'Initials': 'FE', 'LastName': 'de Boer', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'de Bruijn', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Gillebaart', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Marjolein C', 'Initials': 'MC', 'LastName': 'Harbers', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Jody C', 'Initials': 'JC', 'LastName': 'Hoenink', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michel C A', 'Initials': 'MCA', 'LastName': 'Klein', 'Affiliation': 'Social AI group, department of Computer Science, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cédric N H', 'Initials': 'CNH', 'LastName': 'Middel', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Tjerk Jan', 'Initials': 'TJ', 'LastName': 'Schuitmaker-Warnaar', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Velema', 'Affiliation': 'Netherlands Nutrition Centre (Voedingscentrum), The Hague, The Netherlands.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Vos', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Wilma E', 'Initials': 'WE', 'LastName': 'Waterlander', 'Affiliation': 'Department of Public Health, Amsterdam Public Health research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Lakerveld', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joline W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}]",Nutrition journal,['10.1186/s12937-020-00562-8']
2294,31433091,Fluoroscopy guided axillary vein access versus cephalic vein access in pacemaker and defibrillator implantation: Randomized clinical trial of efficacy and safety.,,2019,,['pacemaker and defibrillator implantation'],['Fluoroscopy guided axillary vein access versus cephalic vein access'],[],"[{'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0004456', 'cui_str': 'Axillary Vein'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}]",[],,0.146265,,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Creta', 'Affiliation': ""Barts Heart Centre, St. Bartholomew's Hospital, London, United Kingdom.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Providência', 'Affiliation': ""Barts Heart Centre, St. Bartholomew's Hospital, London, United Kingdom.""}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Finlay', 'Affiliation': ""Barts Heart Centre, St. Bartholomew's Hospital, London, United Kingdom.""}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14115']
2295,31422671,Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association.,"Hypertriglyceridemia (triglycerides 200-499 mg/dL) is relatively common in the United States, whereas more severe triglyceride elevations (very high triglycerides, ≥500 mg/dL) are far less frequently observed. Both are becoming increasingly prevalent in the United States and elsewhere, likely driven in large part by growing rates of obesity and diabetes mellitus. In a 2002 American Heart Association scientific statement, the omega-3 fatty acids (n-3 FAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) were recommended (at a dose of 2-4 g/d) for reducing triglycerides in patients with elevated triglycerides. Since 2002, prescription agents containing EPA+DHA or EPA alone have been approved by the US Food and Drug Administration for treating very high triglycerides; these agents are also widely used for hypertriglyceridemia. The purpose of this advisory is to summarize the lipid and lipoprotein effects resulting from pharmacological doses of n-3 FAs (>3 g/d total EPA+DHA) on the basis of new scientific data and availability of n-3 FA agents. In treatment of very high triglycerides with 4 g/d, EPA+DHA agents reduce triglycerides by ≥30% with concurrent increases in low-density lipoprotein cholesterol, whereas EPA-only did not raise low-density lipoprotein cholesterol in very high triglycerides. When used to treat hypertriglyceridemia, n-3 FAs with EPA+DHA or with EPA-only appear roughly comparable for triglyceride lowering and do not increase low-density lipoprotein cholesterol when used as monotherapy or in combination with a statin. In the largest trials of 4 g/d prescription n-3 FA, non-high-density lipoprotein cholesterol and apolipoprotein B were modestly decreased, indicating reductions in total atherogenic lipoproteins. The use of n-3 FA (4 g/d) for improving atherosclerotic cardiovascular disease risk in patients with hypertriglyceridemia is supported by a 25% reduction in major adverse cardiovascular events in REDUCE-IT (Reduction of Cardiovascular Events With EPA Intervention Trial), a randomized placebo-controlled trial of EPA-only in high-risk patients treated with a statin. The results of a trial of 4 g/d prescription EPA+DHA in hypertriglyceridemia are anticipated in 2020. We conclude that prescription n-3 FAs (EPA+DHA or EPA-only) at a dose of 4 g/d (>3 g/d total EPA+DHA) are an effective and safe option for reducing triglycerides as monotherapy or as an adjunct to other lipid-lowering agents.",2019,The use of n-3 FA (4 g/d) for improving atherosclerotic cardiovascular disease risk in patients with hypertriglyceridemia is supported by a 25% reduction in major adverse cardiovascular events in REDUCE-IT (Reduction of Cardiovascular Events,"['patients with elevated triglycerides', 'patients with hypertriglyceridemia', 'high-risk patients treated with a statin']","['n-3 FA agents', 'n-3 FAs', 'placebo', 'prescription n-3 FAs (EPA+DHA or EPA', 'n-3 FA', 'omega-3 fatty acids (n-3 FAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'Omega-3 Fatty Acids']","['low-density lipoprotein cholesterol', 'density lipoprotein cholesterol and apolipoprotein B', 'total atherogenic lipoproteins', 'atherosclerotic cardiovascular disease risk', 'Hypertriglyceridemia', 'hypertriglyceridemia', 'severe triglyceride elevations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.0770584,The use of n-3 FA (4 g/d) for improving atherosclerotic cardiovascular disease risk in patients with hypertriglyceridemia is supported by a 25% reduction in major adverse cardiovascular events in REDUCE-IT (Reduction of Cardiovascular Events,"[{'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Skulas-Ray', 'Affiliation': ''}, {'ForeName': 'Peter W F', 'Initials': 'PWF', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': ''}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': ''}, {'ForeName': 'Chesney K', 'Initials': 'CK', 'LastName': 'Richter', 'Affiliation': ''}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Jacobson', 'Affiliation': ''}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Engler', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'Conrad B', 'Initials': 'CB', 'LastName': 'Blum', 'Affiliation': ''}, {'ForeName': 'Delfin', 'Initials': 'D', 'LastName': 'Rodriguez-Leyva', 'Affiliation': ''}, {'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'de Ferranti', 'Affiliation': ''}, {'ForeName': 'Francine K', 'Initials': 'FK', 'LastName': 'Welty', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIR.0000000000000709']
2296,30700853,Pilot study of feasibility and effect of anodal transcutaneous spinal direct current stimulation on chronic neuropathic pain after spinal cord injury.,"STUDY DESIGN
A single-blind crossover study.
OBJECTIVES
This study aimed to evaluate neuropathic pain in persons with spinal cord injury (SCI) after the application of transcutaneous spinal direct current stimulation (tsDCS).
SETTING
Outpatient Clinic of the Rehabilitation Department, Seoul National University Hospital.
METHODS
The effect of single sessions of both anodal and sham tsDCS (2 mA, 20 min) on chronic neuropathic pain in ten volunteers with complete motor cervical SCI was assessed. The active electrode was placed over the spinal process of the tenth thoracic vertebra and the reference electrode, at the top of the head. Pre- to post-tsDCS intervention changes in pain intensity (numeric rating scale, NRS), patient global assessment, and present pain intensity (PPI) were assessed before and after the tsDCS session (immediately post stimulation, and at 1 and 2 h post stimulation).
RESULTS
All participants underwent the stimulation procedure without dropout. Our results showed no significant pre- to post-treatment difference in pain intensity between the active and sham tsDCS groups. Only in the sham tsDCS stimulation, NRS and PPI scores were reduced after the stimulation session. Furthermore, in the mixed effect model analysis, the response in the second period appeared to be more favorable.
CONCLUSION
The results suggest that a single session of anodal tsDCS with the montage used in this study is feasible but does not have a significant analgesic effect in individuals with chronic cervical SCI.
SPONSORSHIP
The study was funded by Seoul National University Hospital (No. 0420160470) and Korea Workers' Compensation & Welfare Service.",2019,Our results showed no significant pre- to post-treatment difference in pain intensity between the active and sham tsDCS groups.,"['Outpatient Clinic of the Rehabilitation Department, Seoul National University Hospital', 'individuals with chronic cervical SCI', 'persons with spinal cord injury (SCI', 'after spinal cord injury', ""The study was funded by Seoul National University Hospital (No. 0420160470) and Korea Workers' Compensation & Welfare Service"", 'ten volunteers with complete motor cervical SCI']","['Pre- to post-tsDCS intervention', 'transcutaneous spinal direct current stimulation (tsDCS', 'anodal and sham tsDCS', 'anodal transcutaneous spinal direct current stimulation']","['pain intensity (numeric rating scale, NRS), patient global assessment, and present pain intensity (PPI', 'chronic neuropathic pain', 'pain intensity', 'neuropathic pain', 'NRS and PPI scores']","[{'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department (environment)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0442831', 'cui_str': 'Direct current (physical force)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",10.0,0.116297,Our results showed no significant pre- to post-treatment difference in pain intensity between the active and sham tsDCS groups.,"[{'ForeName': 'Young-Ah', 'Initials': 'YA', 'LastName': 'Choi', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Yale', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung-Ik', 'Initials': 'HI', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Seoul National University, Seoul, Republic of Korea. hyungik1@snu.ac.kr.'}]",Spinal cord,['10.1038/s41393-019-0244-x']
2297,31909887,Pharmacokinetics of isoniazid in children with tuberculosis-A comparative study at two doses.,"AIM
To compare the pharmacokinetics of isoniazid (INH) at doses 5 and 10 mg/kg/day.
METHODS
INH concentrations were estimated by high-performance liquid chromatography in 24 Indian children aged 1 to 15 years on antituberculosis therapy. Blood samples were collected at 0, 2, 4, 6, 8 hours after administration of INH. Patients were randomly given INH at 5 or 10 mg/kg/day and maximum concentrations (C max ) and area under the curve (AUC (0-8) ) were determined in each group. The 2-hour concentration of INH was used as C max for this study.
RESULTS
Mean (standard deviation) C max was reached in 2 hours and was 2.68 ± 1.19 µg/mL in 5 mg/kg/day group and 8.86 ± 3.94 µg/mL in 10 mg/kg/day group (P < .05). The normal therapeutic range at 2-hour concentrations for INH in adults achieving good clinical response is between 3 and 5 µg/mL. Among 5 mg/kg/day, only 4 (33%) patients had INH concentrations within the 2-hour concentrations therapeutic range whereas in 10 mg/kg/day group, 11 (91%) patients achieved C max higher than the 2-hour concentrations therapeutic range and 1 (9%) patient had C max within the 2-hour concentrations therapeutic range. The mean AUC (0-8) in 5 mg/kg/day group was 10.04 ± 6.12 and 35.93 ± 25.37 µg·h/mL in 10 mg/kg/day group (P = .0001).
CONCLUSION
Children on daily INH 10 mg/kg/day have higher AUC and C max than the required therapeutic range whereas over 65% of children with daily 5 mg/kg/day INH therapy failed to achieve the optimal therapeutic range.",2020,"Among 5 mg/kg/day, only 4 (33%) patients had INH concentrations within the 2-hour concentrations therapeutic range whereas in 10 mg/kg/day group, 11 (91%) patients achieved C max higher than the 2-hour concentrations therapeutic range and 1 (9%) patient had C max within the 2-hour concentrations therapeutic range.","['children with tuberculosis', '24 Indian children aged 1 to 15 years on antituberculosis therapy']","['isoniazid (INH', 'isoniazid']","['Mean (standard deviation', 'mean AUC', 'Blood samples', 'INH concentrations', '2-hour concentration of INH', 'C max']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0208681', 'cui_str': 'factor XIIa inhibitor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0208681', 'cui_str': 'factor XIIa inhibitor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",24.0,0.0396882,"Among 5 mg/kg/day, only 4 (33%) patients had INH concentrations within the 2-hour concentrations therapeutic range whereas in 10 mg/kg/day group, 11 (91%) patients achieved C max higher than the 2-hour concentrations therapeutic range and 1 (9%) patient had C max within the 2-hour concentrations therapeutic range.","[{'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Shah', 'Affiliation': 'Pediatric TB Clinic, Department of Pediatric Infectious Diseases, B J Wadia Hospital for Children, Mumbai, India.'}, {'ForeName': 'Sajal', 'Initials': 'S', 'LastName': 'Kumar Das', 'Affiliation': 'Pediatric TB Clinic, Department of Pediatric Infectious Diseases, B J Wadia Hospital for Children, Mumbai, India.'}, {'ForeName': 'Naman S', 'Initials': 'NS', 'LastName': 'Shetty', 'Affiliation': 'Pediatric TB Clinic, Department of Pediatric Infectious Diseases, B J Wadia Hospital for Children, Mumbai, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kannan', 'Affiliation': 'Department of Clinical Pharmacology, National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Clinical Pharmacology, National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Ak Hemanth', 'Initials': 'AH', 'LastName': 'Kumar', 'Affiliation': 'Department of Clinical Pharmacology, National Institute for Research in Tuberculosis, Chennai, India.'}]",Pediatric pulmonology,['10.1002/ppul.24624']
2298,19793473,The role of prophylactic antibiotics in elective laparoscopic cholecystectomy.,"BACKGROUND AND OBJECTIVES
Elective laparoscopic cholecystectomy has a low risk for infectious complications, but many surgeons still use prophylactic antibiotics. The aim of this prospective study was to investigate the necessity and test the efficacy of prophylactic antibiotics on postoperative infection complications in low-risk patients undergoing laparoscopic cholecystectomy.
METHODS
Low-risk patients were randomly placed into 2 groups: 68 patients (group 1) received cefazolin 1g intravenously after induction of anesthesia, and 76 patients (group 2) were not given prophylactic antibiotics. In both groups, septic complications were recorded and compared.
RESULTS
Positive bile culture and gallbladder rupture did not significantly increase the rate of surgical site infections. In group 1, there were 3 (4.41%) cases of wound infection, 3 (4.41%) cases of pulmonary infections, and 1 (1.47%) case of urinary tract infection. In group 2, there were 2 (2.63%) cases of wound infection, 2 (2.63%) case of pulmonary infections, and 3 (3.95%) cases of urinary tract infection. No significant difference existed in the complication rates.
CONCLUSIONS
Based on our data, the use of prophylactic antibiotics does not decrease the rate of postoperative infection complications and surgical-site infections and is not necessary in low-risk patients undergoing laparoscopic cholecystectomy.",2009,"Based on our data, the use of prophylactic antibiotics does not decrease the rate of postoperative infection complications and surgical-site infections and is not necessary in low-risk patients undergoing laparoscopic cholecystectomy.","['Low-risk patients', 'elective laparoscopic cholecystectomy', 'low-risk patients undergoing laparoscopic cholecystectomy']","['prophylactic antibiotics', 'Elective laparoscopic cholecystectomy', 'cefazolin 1g intravenously after induction of anesthesia']","['postoperative infection complications', 'septic complications', 'wound infection', 'Positive bile culture and gallbladder rupture', 'urinary tract infection', 'complication rates', 'pulmonary infections', 'rate of surgical site infections']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}]","[{'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1167872'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}]",,0.0367503,"Based on our data, the use of prophylactic antibiotics does not decrease the rate of postoperative infection complications and surgical-site infections and is not necessary in low-risk patients undergoing laparoscopic cholecystectomy.","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Uludag', 'Affiliation': 'Second Department of General Surgery, Sisli Etfal Training and Research Hospital, Istanbul, Turkey. drmuludag@hotmail.com'}, {'ForeName': 'Gurkan', 'Initials': 'G', 'LastName': 'Yetkin', 'Affiliation': ''}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Citgez', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2299,19793466,Improved outcomes for lap-banding using the Insuflow device compared with heated-only gas.,"BACKGROUND AND OBJECTIVES
Preconditioning gas by humidification and warming the pneumoperitoneum improves laparoscopic outcomes. This prevents peritoneal desiccation and detrimental events related to traditional cold-dry gas. Few comparisons have been done comparing traditional cold-dry, heated-only, and humidified-warmed carbon dioxide.
METHODS
A prospective, controlled, randomized, double-blind study of laparoscopic gastric banding included 113 patients and compared traditional dry-cold (n=35) versus dry-heated (n=40), versus humidified-warm gas (n=38). Pain medications were standardized for all groups. Endpoints were recovery room length of stay, pain location, pain intensity, and total pain medications used postoperatively for up to 10 days.
RESULTS
The humidified-warmed group had statistically significant differences from the other 2 groups with improvement in all end points. The dry-heated group had significantly more pain medication use and increased shoulder and chest pain than the other 2 groups had.
CONCLUSION
Using warm-humidified gas for laparoscopic gastric banding reduces shoulder pain, shortens recovery room length of stay, and decreases pain medication requirements for up to 10 days postoperatively. Dry-heated gas may cause additional complications as is indicated by the increase in pain medication use and pain intensity.",2009,"The dry-heated group had significantly more pain medication use and increased shoulder and chest pain than the other 2 groups had.
","['113 patients and compared traditional dry-cold (n=35) versus dry-heated (n=40), versus humidified-warm gas (n=38']",['laparoscopic gastric banding'],"['recovery room length of stay, pain location, pain intensity, and total pain medications used postoperatively for up to 10 days', 'Pain medications', 'shoulder pain, shortens recovery room length of stay, and decreases pain medication requirements', 'pain medication use and increased shoulder and chest pain', 'pain medication use and pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]","[{'cui': 'C1960832', 'cui_str': 'Partitioning of stomach using band (procedure)'}]","[{'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}]",113.0,0.129228,"The dry-heated group had significantly more pain medication use and increased shoulder and chest pain than the other 2 groups had.
","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Benavides', 'Affiliation': 'Surgery Center of Richardson, Texas, USA. scasey@aigb.com'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Hoang', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2300,31329855,"N-acetyl galactosamine-conjugated antisense drug to APOC3 mRNA, triglycerides and atherogenic lipoprotein levels.","AIMS
Elevated apolipoprotein C-III (apoC-III) levels are associated with hypertriglyceridaemia and coronary heart disease. AKCEA-APOCIII-LRx is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selectively inhibits apoC-III protein synthesis.
METHODS AND RESULTS
The safety, tolerability, and efficacy of AKCEA-APOCIII-LRx was assessed in a double-blind, placebo-controlled, dose-escalation Phase 1/2a study in healthy volunteers (ages 18-65) with triglyceride levels ≥90 or ≥200 mg/dL. Single-dose cohorts were treated with 10, 30, 60, 90, and 120 mg subcutaneously (sc) and multiple-dose cohorts were treated with 15 and 30 mg weekly sc for 6 weeks or 60 mg every 4 weeks sc for 3 months. In the single-dose cohorts treated with 10, 30, 60, 90, or 120 mg of AKCEA-APOCIII-LRx, median reductions of 0, -42%, -73%, -81%, and -92% in apoC-III, and -12%, -7%, -42%, -73%, and -77% in triglycerides were observed 14 days after dosing. In multiple-dose cohorts of 15 and 30 mg weekly and 60 mg every 4 weeks, median reductions of -66%, -84%, and -89% in apoC-III, and -59%, -73%, and -66% in triglycerides were observed 1 week after the last dose. Significant reductions in total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, and increases in HDL-C were also observed. AKCEA-APOCIII-LRx was well tolerated with one injection site reaction of mild erythema, and no flu-like reactions, platelet count reductions, liver, or renal safety signals.
CONCLUSION
Treatment of hypertriglyceridaemic subjects with AKCEA-APOCIII-LRx results in a broad improvement in the atherogenic lipid profile with a favourable safety and tolerability profile. ClinicalTrials.gov Identifier: NCT02900027.",2019,"Significant reductions in total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, and increases in HDL-C were also observed.",['healthy volunteers (ages 18-65) with triglyceride levels ≥90 or ≥200\u2009mg/dL. Single-dose cohorts'],[],"['atherogenic lipid profile', 'APOC3 mRNA, triglycerides and atherogenic lipoprotein levels', 'Elevated apolipoprotein C-III (apoC-III) levels', 'safety, tolerability, and efficacy of AKCEA-APOCIII-LRx', 'total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, and increases in HDL-C', 'triglycerides']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",[],"[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0052191', 'cui_str': 'Apolipoprotein CIII'}, {'cui': 'C4048315', 'cui_str': 'ApoC-III'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0574537,"Significant reductions in total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, and increases in HDL-C were also observed.","[{'ForeName': 'Veronica J', 'Initials': 'VJ', 'LastName': 'Alexander', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Hurh', 'Affiliation': 'Akcea Therapeutics, 22 Boston Wharf Road, 9th Floor, Boston, MA, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Hughes', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': ""O'Dea"", 'Affiliation': 'Akcea Therapeutics, 22 Boston Wharf Road, 9th Floor, Boston, MA, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Geary', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, USA.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}]",European heart journal,['10.1093/eurheartj/ehz209']
2301,31397289,"Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial.","BACKGROUND
Inclusion body myositis is an idiopathic inflammatory myopathy and the most common myopathy affecting people older than 50 years. To date, there are no effective drug treatments. We aimed to assess the safety, efficacy, and tolerability of bimagrumab-a fully human monoclonal antibody-in individuals with inclusion body myositis.
METHODS
We did a multicentre, double-blind, placebo-controlled study (RESILIENT) at 38 academic clinical sites in Australia, Europe, Japan, and the USA. Individuals (aged 36-85 years) were eligible for the study if they met modified 2010 Medical Research Council criteria for inclusion body myositis. We randomly assigned participants (1:1:1:1) using a blocked randomisation schedule (block size of four) to either bimagrumab (10 mg/kg, 3 mg/kg, or 1 mg/kg) or placebo matched in appearance to bimagrumab, administered as intravenous infusions every 4 weeks for at least 48 weeks. All study participants, the funder, investigators, site personnel, and people doing assessments were masked to treatment assignment. The primary outcome measure was 6-min walking distance (6MWD), which was assessed at week 52 in the primary analysis population and analysed by intention-to-treat principles. We used a multivariate normal repeated measures model to analyse data for 6MWD. Safety was assessed by recording adverse events and by electrocardiography, echocardiography, haematological testing, urinalysis, and blood chemistry. This trial is registered with ClinicalTrials.gov, number NCT01925209; this report represents the final analysis.
FINDINGS
Between Sept 26, 2013, and Jan 6, 2016, 251 participants were enrolled to the study, of whom 63 were assigned to each bimagrumab group and 62 were allocated to the placebo group. At week 52, 6MWD change from baseline did not differ between any bimagrumab dose and placebo (least squares mean treatment difference for bimagrumab 10 mg/kg group, 17·6 m, SE 14·3, 99% CI -19·6 to 54·8; p=0·22; for 3 mg/kg group, 18·6 m, 14·2, -18·2 to 55·4; p=0·19; and for 1 mg/kg group, -1·3 m, 14·1, -38·0 to 35·4; p=0·93). 63 (100%) participants in each bimagrumab group and 61 (98%) of 62 in the placebo group had at least one adverse event. Falls were the most frequent adverse event (48 [76%] in the bimagrumab 10 mg/kg group, 55 [87%] in the 3 mg/kg group, 54 [86%] in the 1 mg/kg group, and 52 [84%] in the placebo group). The most frequently reported adverse events with bimagrumab were muscle spasms (32 [51%] in the bimagrumab 10 mg/kg group, 43 [68%] in the 3 mg/kg group, 25 [40%] in the 1 mg/kg group, and 13 [21%] in the placebo group) and diarrhoea (33 [52%], 28 [44%], 20 [32%], and 11 [18%], respectively). Adverse events leading to discontinuation were reported in four (6%) participants in each bimagrumab group compared with one (2%) participant in the placebo group. At least one serious adverse event was reported by 21 (33%) participants in the 10 mg/kg group, 11 (17%) in the 3 mg/kg group, 20 (32%) in the 1 mg/kg group, and 20 (32%) in the placebo group. No significant adverse cardiac effects were recorded on electrocardiography or echocardiography. Two deaths were reported during the study, one attributable to subendocardial myocardial infarction (secondary to gastrointestinal bleeding after an intentional overdose of concomitant sedatives and antidepressants) and one attributable to lung adenocarcinoma. Neither death was considered by the investigator to be related to bimagrumab.
INTERPRETATION
Bimagrumab showed a good safety profile, relative to placebo, in individuals with inclusion body myositis but did not improve 6MWD. The strengths of our study are that, to the best of our knowledge, it is the largest randomised controlled trial done in people with inclusion body myositis, and it provides important natural history data over 12 months.
FUNDING
Novartis Pharma.",2019,"Falls were the most frequent adverse event (48 [76%] in the bimagrumab 10 mg/kg group, 55 [87%] in the 3 mg/kg group, 54 [86%] in the 1 mg/kg group, and 52 [84%] in the placebo group).","['Individuals (aged 36-85 years) were eligible for the study if they met modified 2010 Medical Research Council criteria for inclusion body myositis', 'people older than 50 years', ' at 38 academic clinical sites in Australia, Europe, Japan, and the USA', 'Between Sept 26, 2013, and Jan 6, 2016, 251 participants were enrolled to the study, of whom 63 were assigned to each bimagrumab group and 62 were allocated to the', 'individuals with inclusion body myositis']","['intravenous bimagrumab', 'placebo', 'bimagrumab-a fully human monoclonal antibody', 'bimagrumab']","['diarrhoea', 'adverse cardiac effects', 'adverse events and by electrocardiography, echocardiography, haematological testing, urinalysis, and blood chemistry', 'Safety and efficacy', 'serious adverse event', 'subendocardial myocardial infarction', '6MWD', 'safety, efficacy, and tolerability', 'adverse event', 'muscle spasms', '6-min walking distance (6MWD']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0238190', 'cui_str': 'Myositis, Inclusion Body'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0262568', 'cui_str': 'Subendocardial myocardial infarction'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",251.0,0.673075,"Falls were the most frequent adverse event (48 [76%] in the bimagrumab 10 mg/kg group, 55 [87%] in the 3 mg/kg group, 54 [86%] in the 1 mg/kg group, and 52 [84%] in the placebo group).","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Hanna', 'Affiliation': 'Medical Research Council (MRC) Centre for Neuromuscular Diseases, University College London (UCL) Institute of Neurology, London, UK. Electronic address: m.hanna@ucl.ac.uk.'}, {'ForeName': 'Umesh A', 'Initials': 'UA', 'LastName': 'Badrising', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Benveniste', 'Affiliation': 'Department of Internal Medicine and Clinical Immunology, Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Lloyd', 'Affiliation': 'Department of Neuroscience, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Merrilee', 'Initials': 'M', 'LastName': 'Needham', 'Affiliation': 'Fiona Stanley Hospital, Institute for Immunology & Infectious Diseases Murdoch University and Notre Dame University, Perth, WA, Australia.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Chinoy', 'Affiliation': 'National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Aoki', 'Affiliation': 'Department of Neurology, Tohoku University School of Medicine, Sendai, Japan.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Machado', 'Affiliation': 'Medical Research Council (MRC) Centre for Neuromuscular Diseases, University College London (UCL) Institute of Neurology, London, UK; Centre for Rheumatology, Division of Medicine, UCL, London, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Reardon', 'Affiliation': 'Calvary Health Care Bethlehem, Caulfield South, VIC, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'de Visser', 'Affiliation': 'Department of Neurology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Dana P', 'Initials': 'DP', 'LastName': 'Ascherman', 'Affiliation': 'Department of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Mazen M', 'Initials': 'MM', 'LastName': 'Dimachkie', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'James A L', 'Initials': 'JAL', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': 'Department of Neurology, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Oskarsson', 'Affiliation': 'UC Davis School of Medicine, Neuromuscular Research Center, Sacramento, CA, USA.'}, {'ForeName': 'Nanette C', 'Initials': 'NC', 'LastName': 'Joyce', 'Affiliation': 'UC Davis School of Medicine, Neuromuscular Research Center, Sacramento, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van den Bergh', 'Affiliation': 'Department of Neurology, University Hospital Saint-Luc, University of Louvain, Brussels, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Baets', 'Affiliation': 'Neuromuscular Reference Centre, Department of Neurology, Antwerp University Hospital, and the Institute Born-Bunge, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'De Bleecker', 'Affiliation': 'Department of Neurology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'David', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston, MA, USA.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mirabella', 'Affiliation': 'Department of Neurology, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Universitá Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Sharon P', 'Initials': 'SP', 'LastName': 'Nations', 'Affiliation': 'Department of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Hans H', 'Initials': 'HH', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pegoraro', 'Affiliation': 'Department of Neurosciences, University of Padua School of Medicine, Padua, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Maggi', 'Affiliation': 'Neuroimmunology and Neuromuscular Diseases Unit, Foundation IRCCS Neurological Institute Carlo Besta, Milan, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Rodolico', 'Affiliation': 'Unit of Neurology and Neuromuscular Disorders, Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina, Messina, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Filosto', 'Affiliation': 'Center for Neuromuscular Diseases, Unit of Neurology, Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy.'}, {'ForeName': 'Aziz I', 'Initials': 'AI', 'LastName': 'Shaibani', 'Affiliation': 'Nerve and Muscle Center of Texas, Houston, TX, USA.'}, {'ForeName': 'Kumaraswamy', 'Initials': 'K', 'LastName': 'Sivakumar', 'Affiliation': 'Neuromuscular Research Center, Phoenix, AZ, USA.'}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': 'Department of Neurology, University of California Irvine, Amyotrophic Lateral Sclerosis & Neuromuscular Center, Orange, CA, USA.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Mori-Yoshimura', 'Affiliation': 'Department of Neurology, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Department of Neurology, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Masahisa', 'Initials': 'M', 'LastName': 'Katsuno', 'Affiliation': 'Department of Neurology, Nagoya University Hospital, Aichi, Japan.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': 'Wakayama Medical University Hospital, Wakayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nodera', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Ichizo', 'Initials': 'I', 'LastName': 'Nishino', 'Affiliation': 'Department of Neuromuscular Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Carla D', 'Initials': 'CD', 'LastName': 'Romano', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, NC, USA.'}, {'ForeName': 'Valerie S L', 'Initials': 'VSL', 'LastName': 'Williams', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lixin Zhang', 'Initials': 'LZ', 'LastName': 'Auberson', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Vera', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Dimitris A', 'Initials': 'DA', 'LastName': 'Papanicolaou', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30200-5']
2302,19660204,Flexible and rigid cystoscopy in women.,"PURPOSE
Previous studies have evaluated the tolerability of rigid versus flexible cystoscopy in men. Similar studies, however, have not been performed in women. We sought to determine whether office-based flexible cystoscopy was better tolerated than rigid cystoscopy in women.
MATERIALS AND METHODS
Following full IRB approval, women were prospectively randomized in a single-blind manner. Patients were randomized to flexible or rigid cystoscopy and draped in the lithotomy position to maintain blinding of the study. Questionnaires evaluated discomfort before, during, and after cystoscopy.
RESULTS
Thirty-six women were randomized to flexible (18) or rigid (18) cystoscopy. Indications were surveillance (16), hematuria (15), recurrent UTIs (2), voiding dysfunction (1), and other (2). All questionnaires were returned by 31/36 women. Using a 10-point visual analog scale (VAS), median discomfort during the procedure for flexible and rigid cystoscopy were 1.4 and 1.8, respectively, in patients perceiving pain. Median recalled pain 1 week later was similar at 0.8 and 1.15, respectively. None of these differences were statistically significant.
CONCLUSIONS
Flexible and rigid cystoscopy are well tolerated in women. Discomfort during and after the procedure is minimal in both groups. Urologists should perform either procedure in women based on their preference and skill level.",2009,Discomfort during and after the procedure is minimal in both groups.,"['men', 'women', 'Thirty-six women']","['Flexible and rigid cystoscopy', 'flexible or rigid cystoscopy and draped in the lithotomy position', 'office-based flexible cystoscopy', 'flexible (18) or rigid (18) cystoscopy', 'rigid versus flexible cystoscopy', 'rigid cystoscopy']","['hematuria (15), recurrent UTIs (2), voiding dysfunction (1), and other (2', 'Discomfort', '10-point visual analog scale (VAS), median discomfort during the procedure for flexible and rigid cystoscopy', 'Median recalled pain']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0577993', 'cui_str': 'Rigid cystoscopy (procedure)'}, {'cui': 'C0150665', 'cui_str': 'Lithotomy position (finding)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy (procedure)'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}]","[{'cui': 'C0018965', 'cui_str': 'Hematuria'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0429826', 'cui_str': 'Dysfunctional voiding of urine (finding)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0577993', 'cui_str': 'Rigid cystoscopy (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",36.0,0.0786042,Discomfort during and after the procedure is minimal in both groups.,"[{'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Gee', 'Affiliation': 'Department of Urology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin 53792, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Waterman', 'Affiliation': ''}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Jarrard', 'Affiliation': ''}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Hedican', 'Affiliation': ''}, {'ForeName': 'Reginald C', 'Initials': 'RC', 'LastName': 'Bruskewitz', 'Affiliation': ''}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Nakada', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2303,31557306,Pharmacogenomics and Placebo Response in a Randomized Clinical Trial in Asthma.,"Genetic variation may differentially modify drug and placebo treatment effects in randomized clinical trials. In asthma, although lung function and asthma control improvements are commonplace with placebo, pharmacogenomics of placebo vs. drug response remains unexamined. In a genomewide association study of subjective and objective outcomes with placebo treatment in Childhood Asthma Management Program of nedocromil/budesonide vs. placebo (N = 604), effect estimates for lead single nucleotide polymorphisms (SNPs) were compared across arms. The coughing/wheezing lead SNP, rs2392165 (β = 0.94; P = 1.10E-07) mapped to BBS9, a gene implicated in lung development that contains a lung function expression quantitative trait locus. The effect was attenuated with budesonide (P interaction = 1.48E-07), but not nedocromil (P interaction = 0.06). The lead forced vital capacity SNP, rs12930749 (β = -5.80; P = 1.47E-06), mapped to KIAA0556, a locus genomewide associated with respiratory diseases. The rs12930749 effect was attenuated with budesonide (P interaction = 1.32E-02) and nedocromil (P interaction = 1.09E-02). Pharmacogenomic analysis revealed differential effects with placebo and drug treatment that could potentially guide precision drug development in asthma.",2019,The rs12930749 effect was attenuated with budesonide (P interaction =1.32E-02) and nedocromil (P interaction =1.09E-02).,[],"['placebo', 'nedocromil', 'budesonide', 'nedocromil/budesonide versus placebo']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068483', 'cui_str': 'Nedocromil'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]",[],,0.212646,The rs12930749 effect was attenuated with budesonide (P interaction =1.32E-02) and nedocromil (P interaction =1.09E-02).,"[{'ForeName': 'Rui-Sheng', 'Initials': 'RS', 'LastName': 'Wang', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Damien C', 'Initials': 'DC', 'LastName': 'Croteau-Chonka', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Edwin K', 'Initials': 'EK', 'LastName': 'Silverman', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Loscalzo', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Hall', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1646']
2304,31366435,Strategies for Improving Influenza Vaccination Rates in Patients with Chronic Renal Disease.,"BACKGROUND
The influenza vaccination rate among older and chronically ill patients in Germany has declined in the past decade in spite of vaccination campaigns.
METHODS
The influenza vaccination rate among persons with chronic renal disease was studied with the aid of billing data from various Associations of Statutory Health Insurance Physicians (Kassenärztliche Vereinigungen, ASHIPs) in Germany. It was tested in a randomized controlled trial whether a written vaccination appeal, sent by physicians to patients, led to an increase in the vaccination rate. It was tested in a further such trial whether the vaccination rate among patients with renal disease could be improved by an appeal for vaccination that was sent by the ASHIPs to the treating nephrologists. Finally, it was also tested in a prospective interventional study whether the vaccination rate could be improved by an appeal for vaccination sent by a health- insurance carrier directly to the patients.
RESULTS
In 2012-2017, the vaccination rate among persons with chronically impaired renal function ranged from 41.1% to 46.9%; it ranged from 31.7% to 33.7% in kidney transplant recipients and from 42.7% to 44.7% in dialysis patients. An appeal for vaccination that was sent from physicians to patients raised the vaccination rate by 8.3% in the intervention group compared to the control group (p = 0.03; number needed to treat [NNT]: 13). On the other hand, an appeal for vaccination that was sent to the nephrologists lowered the vaccination rate by 0.8% in the intervention group compared to the control group. Finally, an appeal for vaccination that was sent by the health-insurance fund to the patients raised the vaccination rate by 3.2% (p<0.001; NNT: 32).
CONCLUSION
Fewer than half of all patients with chronic renal failure in Germany are vaccinated against influenza. The vaccination rate was found to be increased only after an appeal for vaccination that was sent directly to the patients. A letter sent to the treating physicians had no positive effect at all.",2019,An appeal for vaccination that was sent from physicians to patients raised the vaccination rate by 8.3% in the intervention group compared to the control group (p = 0.03; number needed to treat [NNT]: 13).,"['patients with renal disease', 'Patients with Chronic Renal Disease', 'older and chronically ill patients in Germany', 'persons with chronic renal disease was studied with the aid of billing data from various Associations of Statutory Health Insurance Physicians (Kassenärztliche Vereinigungen, ASHIPs) in Germany']",[],"['Influenza Vaccination Rates', 'influenza vaccination rate', 'renal function', 'vaccination rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]",[],"[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.022799,An appeal for vaccination that was sent from physicians to patients raised the vaccination rate by 8.3% in the intervention group compared to the control group (p = 0.03; number needed to treat [NNT]: 13).,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Schulte', 'Affiliation': 'Department of Nephrology and Hypertension. University Hospital Schleswig-Holstein; Department of Strategic Data Analysis and Health Policy North Rhine-Westphalia, North Rhine Association of Statutory Health Insurance Physicians, Düsseldorf; IKK Südwest, Saarbrücken; Medical Department, Division of Infectiology and Pneumology, Faculty of Medicine, Charite Berlin; Center for Renal, Hypertensive, and Metabolic Diseases, Hanover; Institute of Medical Informatics and Statistics, University of Kie; Division of Information Technology-Analysis and Development, Schleswig-Holstein Association of Statutory Health Insurance Physicians, Bad Segeberg; Thuringia Association of Statutory Health Insurance Physicians, Weimar.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schierke', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Tamayo', 'Affiliation': ''}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Hager', 'Affiliation': ''}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Engehausen', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Raspe', 'Affiliation': ''}, {'ForeName': 'Ralf-Harto', 'Initials': 'RH', 'LastName': 'Hübner', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schlieper', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Borzikowsky', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Urbschat', 'Affiliation': ''}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Auerswald', 'Affiliation': ''}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Kunzendorf', 'Affiliation': ''}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Feldkamp', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0413']
2305,31397263,The 4 'A's test for detecting delirium in acute medical patients: a diagnostic accuracy study.,"BACKGROUND
Delirium is a common and serious neuropsychiatric syndrome, usually triggered by illness or drugs. It remains underdetected. One reason for this is a lack of brief, pragmatic assessment tools. The 4 'A's test (Arousal, Attention, Abbreviated Mental Test - 4, Acute change) (4AT) is a screening tool designed for routine use. This project evaluated its usability, diagnostic accuracy and cost.
METHODS
Phase 1 - the usability of the 4AT in routine practice was measured with two surveys and two qualitative studies of health-care professionals, and a review of current clinical use of the 4AT as well as its presence in guidelines and reports. Phase 2 - the 4AT's diagnostic accuracy was assessed in newly admitted acute medical patients aged ≥ 70 years. Its performance was compared with that of the Confusion Assessment Method (CAM; a longer screening tool). The performance of individual 4AT test items was related to cognitive status, length of stay, new institutionalisation, mortality at 12 weeks and outcomes. The method used was a prospective, double-blind diagnostic test accuracy study in emergency departments or in acute general medical wards in three UK sites. Each patient underwent a reference standard delirium assessment and was also randomised to receive an assessment with either the 4AT ( n = 421) or the CAM ( n = 420). A health economics analysis was also conducted.
RESULTS
Phase 1 found evidence that delirium awareness is increasing, but also that there is a need for education on delirium in general and on the 4AT in particular. Most users reported that the 4AT was useful, and it was in widespread use both in the UK and beyond. No changes to the 4AT were considered necessary. Phase 2 involved 785 individuals who had data for analysis; their mean age was 81.4 (standard deviation 6.4) years, 45% were male, 99% were white and 9% had a known dementia diagnosis. The 4AT ( n = 392) had an area under the receiver operating characteristic curve of 0.90. A positive 4AT score (> 3) had a specificity of 95% [95% confidence interval (CI) 92% to 97%] and a sensitivity of 76% (95% CI 61% to 87%) for reference standard delirium. The CAM ( n = 382) had a specificity of 100% (95% CI 98% to 100%) and a sensitivity of 40% (95% CI 26% to 57%) in the subset of participants whom it was possible to assess using this. Patients with positive 4AT scores had longer lengths of stay (median 5 days, interquartile range 2.0-14.0 days) than did those with negative 4AT scores (median 2 days, interquartile range 1.0-6.0 days), and they had a higher 12-week mortality rate (16.1% and 9.2%, respectively). The estimated 12-week costs of an initial inpatient stay for patients with delirium were more than double the costs of an inpatient stay for patients without delirium (e.g. in Scotland, £7559, 95% CI £7362 to £7755, vs. £4215, 95% CI £4175 to £4254). The estimated cost of false-positive cases was £4653, of false-negative cases was £8956, and of a missed diagnosis was £2067.
LIMITATIONS
Patients were aged ≥ 70 years and were assessed soon after they were admitted, limiting generalisability. The treatment of patients in accordance with reference standard diagnosis limited the ability to assess comparative cost-effectiveness.
CONCLUSIONS
These findings support the use of the 4AT as a rapid delirium assessment instrument. The 4AT has acceptable diagnostic accuracy for acute older patients aged > 70 years.
FUTURE WORK
Further research should address the real-world implementation of delirium assessment. The 4AT should be tested in other populations.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN53388093.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 40. See the NIHR Journals Library website for further project information. The funder specified that any new delirium assessment tool should be compared against the CAM, but had no other role in the study design or conduct of the study.",2019,"The performance of individual 4AT test items was related to cognitive status, length of stay, new institutionalisation, mortality at 12 weeks and outcomes.","['785 individuals who had data for analysis; their mean age was 81.4 (standard deviation 6.4', 'acute medical patients', 'emergency departments or in acute general medical wards in three UK sites', 'years, 45% were male, 99% were white and 9% had a known dementia diagnosis', 'Patients were aged ≥\u200970 years and were assessed soon after they were admitted, limiting generalisability', 'acute older patients aged >\u200970 years', 'newly admitted acute medical patients aged ≥\u200970 years', 'patients with delirium']","['CAM', '4AT']","['longer lengths of stay', '12-week mortality rate', 'usability, diagnostic accuracy and cost', 'negative 4AT scores', 's test (Arousal, Attention, Abbreviated Mental Test - 4, Acute change) (4AT', 'cognitive status, length of stay, new institutionalisation, mortality', 'positive 4AT score']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",[],"[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0450977', 'cui_str': ""Hodkinson's test""}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",785.0,0.218407,"The performance of individual 4AT test items was related to cognitive status, length of stay, new institutionalisation, mortality at 12 weeks and outcomes.","[{'ForeName': 'Alasdair Mj', 'Initials': 'AM', 'LastName': 'MacLullich', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Shenkin', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Goodacre', 'Affiliation': 'Emergency Medicine, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Godfrey', 'Affiliation': 'Health and Social Care, Leeds Institute of Health Sciences, School of Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Hanley', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Antaine', 'Initials': 'A', 'LastName': 'Stíobhairt', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lavender', 'Affiliation': 'Health and Social Care, Leeds Institute of Health Sciences, School of Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Boyd', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Stephen', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'MacRaild', 'Affiliation': 'Emergency Medicine Research Group (EMERGE), NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Steven', 'Affiliation': 'Emergency Medicine Research Group (EMERGE), NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Black', 'Affiliation': 'Emergency Medicine Research Group (EMERGE), NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Diernberger', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Zoë', 'Initials': 'Z', 'LastName': 'Tieges', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford, UK.'}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Siddiqi', 'Affiliation': 'Psychiatry, University of York, York.'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23400']
2306,31560581,"Minimally Invasive Radical Hysterectomy for Cervical Cancer: When Adoption of a Novel Treatment Precedes Prospective, Randomized Evidence.",,2019,,['Cervical Cancer'],['Minimally Invasive Radical Hysterectomy'],[],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}]",[],,0.0168194,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Melamed', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'J Alejandro', 'Initials': 'JA', 'LastName': 'Rauh-Hain', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01164']
2307,31073361,Comparative Evaluation between Single Noncompression Miniplate and Two Noncompression Miniplates in the Treatment of Mandibular Angle Fractures.,"This study was conducted to compare the outcome of single noncompression miniplate versus two noncompression miniplates in the treatment of mandibular angle fracture. A total of 40 patients were divided into two groups: Group I ( n = 20), patients were treated by single miniplate at superior border of mandible by intraoral approach; Group II ( n = 20), patients were treated by one miniplate at superior border of mandible, intraorally, and another at the lateral aspect of angle, transbuccally by trocar and cannula. Comparative evaluation was done at 1, 2, 4, 6, and 12 weeks and 6 months. The findings of this study suggest that there was no significant difference in postoperative complications (malocclusion, pain, swelling, infection, facial nerve injury, wound dehiscence, plate exposure) and bite force between the two groups.",2019,"The findings of this study suggest that there was no significant difference in postoperative complications (malocclusion, pain, swelling, infection, facial nerve injury, wound dehiscence, plate exposure) and bite force between the two groups.","['40 patients', 'Mandibular Angle Fractures', 'mandibular angle fracture']",['single noncompression miniplate versus two noncompression miniplates'],"['postoperative complications (malocclusion, pain, swelling, infection, facial nerve injury, wound dehiscence, plate exposure) and bite force']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0161408', 'cui_str': 'Injuries, Cranial Nerve VII'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence (morphologic abnormality)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}]",40.0,0.0163272,"The findings of this study suggest that there was no significant difference in postoperative complications (malocclusion, pain, swelling, infection, facial nerve injury, wound dehiscence, plate exposure) and bite force between the two groups.","[{'ForeName': 'Shubhamoy', 'Initials': 'S', 'LastName': 'Mondal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Mishra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Gaur', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sardar Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India.'}]",Craniomaxillofacial trauma & reconstruction,['10.1055/s-0038-1629907']
2308,19366542,Prevention of postlaparoscopic shoulder pain by forced evacuation of residual CO(2).,"BACKGROUND AND OBJECTIVES
Shoulder pain is one of the early postlaparoscopic symptoms related to CO(2) used for pneumoperitoneum and remaining in the abdomen. The present study was conducted to validate the hypothesis that complete evacuation of the residual CO(2) would prevent postlaparoscopic shoulder pain.
METHODS
Forty consecutive patients, the candidates for gynecologic laparoscopic surgery, were randomly enrolled into one of the following 2 groups. Nineteen patients entered Group I where the residual CO(2) was evacuated by abdominal oppression and served as the study control group. The remaining 21 patients entered Group II, where the residual CO(2) was evacuated by pumping warm saline into the abdomen until it spilled out of the open ports. Nurses, blind to the patient's grouping, recorded shoulder pain VAS scores twice daily.
RESULTS
VAS scores in Group I started to increase at Day 1AM, reached a peak at Day 1PM, and decreased gradually thereafter. VAS scores in Group II stayed low throughout the investigation period. The difference was highly significant (P<0.001).
CONCLUSIONS
Abdominal filling with saline at the end of laparoscopic surgery effectively evacuates residual CO(2) thus preventing postlaparoscopic shoulder pain.",2009,VAS scores in Group II stayed low throughout the investigation period.,"['Nineteen patients entered Group I where the residual CO(2) was evacuated by abdominal oppression and served as the study control group', 'Forty consecutive patients, the candidates for gynecologic laparoscopic surgery']",[],"['VAS scores', 'shoulder pain VAS scores twice daily']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0522171', 'cui_str': 'Sense of oppression (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]",40.0,0.0201347,VAS scores in Group II stayed low throughout the investigation period.,"[{'ForeName': 'Rumiko', 'Initials': 'R', 'LastName': 'Suginami', 'Affiliation': 'Department of Gynecology, Takanohara Central Hospital, Nara, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Taniguchi', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Suginami', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2309,32428027,Effects of the Community Score Card approach on reproductive health service-related outcomes in Malawi.,"BACKGROUND
Social accountability approaches are increasingly being employed in low-resource settings to improve government services. In line with the continuous quality improvement (CQI) philosophy that quality is the product of a linked chain, collaborative social accountability approaches like the Community Score Card (CSC) aim to empower clients and frontline service providers to transform their own lives and hold public officials to account for state obligations. Despite being a critical focus of collaborative social accountability approaches, to our knowledge, a quantitative survey of health workers to understand the impact of these approaches on their self-reported responsibilities and service provision has not been conducted. To fill this gap, we carried out a quantitative survey with health workers to assess the CSC's impact on health worker-reported service responsibilities and provision and complement women's self-reports.
METHODS
We evaluated the effect of the CSC on reproductive health-related outcomes using a cluster-randomized design in Ntcheu district, Malawi. We matched 10 pairs of health facilities and surrounding catchment communities; one from each pair was randomly assigned to the intervention and control arms. The intervention communities and health workers each completed 3-4 cycles of the CSC process by endline. We then surveyed all health workers in the 20 intervention and comparison sites at endline (n = 412) to estimate the intervention's impact.
RESULTS
Significantly (p < .05) more health workers in the CSC intervention areas compared to control areas reported responsibility for antenatal care, comprehensive antenatal care counseling, recording of the number of pregnant and postpartum women seen each month, and the average age of their last family planning client was younger. In addition, marginally significantly (p < .10) more health workers in treatment versus control areas report visiting women at their home at least once during their pregnancy. However, health worker-reported responsibility for HIV testing was significantly lower in intervention areas than in control.
CONCLUSIONS
The CSC aims to empower health workers to collaborate with the community and rest of the health system to identify and overcome the diverse and context-specific range of performance barriers they face. In doing so, it aims to support them to demand and ensure quality care for themselves from the health system so they can, in turn, deliver quality services to clients. Our results contribute to the evidence that the CSC may hold promise at improving service provision. While there is increasing evidence that collaborative social accountability approaches like the CSC are effective means to improving reproductive health-related service provision and outcomes in low-resource settings, additional research is needed.",2020,"Significantly (p < .05) more health workers in the CSC intervention areas compared to control areas reported responsibility for antenatal care, comprehensive antenatal care counseling, recording of the number of pregnant and postpartum women seen each month, and the average age of their last family planning client was younger.","['surveyed all health workers in the 20 intervention and comparison sites at endline (n = 412', 'reproductive health service-related outcomes in Malawi', 'We matched 10 pairs of health facilities and surrounding catchment communities']","['Community Score Card approach', 'CSC']",['health workers'],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1136000', 'cui_str': 'Reproductive Health Services'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",,0.064098,"Significantly (p < .05) more health workers in the CSC intervention areas compared to control areas reported responsibility for antenatal care, comprehensive antenatal care counseling, recording of the number of pregnant and postpartum women seen each month, and the average age of their last family planning client was younger.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gullo', 'Affiliation': 'CARE USA, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Galavotti', 'Affiliation': 'CARE USA, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sebert Kuhlmann', 'Affiliation': 'College for Public Health & Social Justice, Saint Louis University, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Thumbiko', 'Initials': 'T', 'LastName': 'Msiska', 'Affiliation': 'CARE Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Hastings', 'Affiliation': 'Far Harbor, LLC, Austin, TX, United States of America.'}, {'ForeName': 'C Nathan', 'Initials': 'CN', 'LastName': 'Marti', 'Affiliation': 'Far Harbor, LLC, Austin, TX, United States of America.'}]",PloS one,['10.1371/journal.pone.0232868']
2310,19249750,Varenicline reduces alcohol self-administration in heavy-drinking smokers.,"BACKGROUND
Alcohol and tobacco dependence are highly comorbid disorders, with preclinical evidence suggesting a role for nicotinic acetylcholine receptors (nAChRs) in alcohol consumption. Varenicline, a partial nicotinic agonist with high affinity for the alpha4beta2 nAChR receptor, reduced ethanol intake in rodents. We aimed to test whether varenicline would reduce alcohol consumption and alcohol craving in humans.
METHODS
This double-blind, placebo-controlled investigation examined the effect of varenicline (2 mg/day vs. placebo) on alcohol self-administration using an established laboratory paradigm in non-alcohol-dependent heavy drinkers (n = 20) who were daily smokers. Following 7 days of medication pretreatment, participants were first administered a priming dose of alcohol (.3 g/kg) and subjective, and physiologic responses were assessed. A 2-hour alcohol self-administration period followed during which participants could choose to consume up to 8 additional drinks (each .15 g/kg).
RESULTS
Varenicline (.5 +/- SE = .40) significantly reduced the number of drinks consumed compared to placebo (2.60 +/- SE = .93) and increased the likelihood of abstaining from any drinking during the self-administration period. Following the priming drink, varenicline attenuated alcohol craving and reduced subjective reinforcing alcohol effects (high, like, rush, feel good, intoxicated). Adverse events associated with varenicline were minimal and, when combined with alcohol, produced no significant effects on physiologic reactivity, mood, or nausea.
CONCLUSIONS
This preliminary investigation demonstrated that varenicline significantly reduced alcohol self-administration and was well tolerated, alone and in combination with alcohol in heavy-drinking smokers. Varenicline should be investigated as a potential treatment for alcohol use disorders.",2009,"Adverse events associated with varenicline were minimal and, when combined with alcohol, produced no significant effects on physiologic reactivity, mood, or nausea.
","['heavy-drinking smokers', 'non-alcohol-dependent heavy drinkers (n = 20) who were daily smokers', 'rodents', 'humans']","['varenicline (2 mg/day vs. placebo', 'varenicline', 'placebo', 'Varenicline']","['number of drinks', 'physiologic reactivity, mood, or nausea', 'alcohol consumption and alcohol craving', 'alcohol craving and reduced subjective reinforcing alcohol effects']","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0035804', 'cui_str': 'Rodentias'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",20.0,0.0700604,"Adverse events associated with varenicline were minimal and, when combined with alcohol, produced no significant effects on physiologic reactivity, mood, or nausea.
","[{'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'McKee', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut 06519, USA. sherry.mckee@yale.edu'}, {'ForeName': 'Emily L R', 'Initials': 'EL', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': ''}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': ''}, {'ForeName': 'Marina R', 'Initials': 'MR', 'LastName': 'Picciotto', 'Affiliation': ''}, {'ForeName': 'Ismene L', 'Initials': 'IL', 'LastName': 'Petrakis', 'Affiliation': ''}, {'ForeName': 'Naralys', 'Initials': 'N', 'LastName': 'Estevez', 'Affiliation': ''}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Balchunas', 'Affiliation': ''}]",Biological psychiatry,['10.1016/j.biopsych.2009.01.029']
2311,31625915,Pulmonary artery denervation - the time has come for a multicentre blinded randomised controlled trial.,,2019,,[],[],[],[],[],[],,0.36727,,"[{'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Lang', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJV15I8A122']
2312,28945833,"De-escalation strategies in HER2-positive early breast cancer (EBC): final analysis of the WSG-ADAPT HER2+/HR- phase II trial: efficacy, safety, and predictive markers for 12 weeks of neoadjuvant dual blockade with trastuzumab and pertuzumab ± weekly paclitaxel.","Background
Response rates in HER2-overexpressing EBC treated with neoadjuvant chemotherapy and trastuzumab (T) have been improved by addition of pertuzumab (P). The prospective, phase II, neoadjuvant WSG-ADAPT HER2+/HR- trial assessed whether patients with strong early response to dual blockade alone might achieve pathological complete response (pCR) comparable to that of patients receiving dual blockade and chemotherapy.
Patients and methods
Female patients with HER2+/HR- EBC (M0) were randomized (5:2) to 12 weeks of T + P ± weekly paclitaxel (pac) at 80 mg/m2. Early response was defined as proliferation decrease ≥30% of Ki-67 (versus baseline) or low cellularity (<500 invasive tumor cells) in the 3-week biopsy. The trial was designed to test non-inferiority for pCR in early responding patients of the T + P arm versus all chemotherapy-treated patients.
Results
From February 2014 to December 2015, 160 patients were screened, 92 were randomized to T + P and 42 to T + P+pac. Baseline characteristics were well balanced (median age 54 versus 51.5 years, cT2 51.1 versus 52.4%, cN0 54.3 versus 61.9%); 91.3% of patients completed T + P per protocol and 92.9% T + P+pac. The pCR rate in the T + P+pac arm was 90.5%, compared with 36.3% in the T + P arm as a whole. In the T + P arm, 24/92 were classified as non-responders, and their pCR rate was only 8.3% compared with 44.7% in responders (38/92) and 42.9% in patients with unclassified early response (30/92). No new safety signals were observed in the study population.
Conclusion
Addition of taxane monotherapy to dual HER2 blockade in a 12-week neoadjuvant setting substantially increases pCR rates in HER2+/HR- EBC compared with dual blockade alone, even within early responders to dual blockade. Early non-response under dual blockade strongly predicts failure to achieve pCR.",2017,"The pCR rate in the T + P+pac arm was 90.5%, compared with 36.3% in the T + P arm as a whole.","['Results\n\n\nFrom February 2014 to December 2015', 'early responding patients of the T\u2009+\u2009P arm versus all chemotherapy-treated patients', 'patients with strong early response', '160 patients were screened, 92 were randomized to T\u2009+\u2009P and 42 to T\u2009+\u2009P+pac', 'Patients and methods\n\n\nFemale patients with HER2+/HR- EBC (M0', 'HER2-positive early breast cancer (EBC']","['T\u2009+\u2009P\u2009±\u2009weekly paclitaxel (pac) at 80\u2009mg/m2', 'taxane monotherapy', 'trastuzumab and pertuzumab ± weekly paclitaxel', 'neoadjuvant chemotherapy and trastuzumab (T']","['pCR rate', 'pCR rates']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",92.0,0.0627124,"The pCR rate in the T + P+pac arm was 90.5%, compared with 36.3% in the T + P arm as a whole.","[{'ForeName': 'U A', 'Initials': 'UA', 'LastName': 'Nitz', 'Affiliation': 'West German Study Group GmbH, Moenchengladabach; Evangelical Hospital Johanniter Bethesda, Breast Center Niederrhein, Moenchengladbach.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Gluz', 'Affiliation': 'West German Study Group GmbH, Moenchengladabach; Evangelical Hospital Johanniter Bethesda, Breast Center Niederrhein, Moenchengladbach; University of Cologne, Cologne. Electronic address: oleg.gluz@wsg-online.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Christgen', 'Affiliation': 'Institute of Pathology, Medical School Hannover, Hannover.'}, {'ForeName': 'E-M', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': 'Department of Gynecology and Obstetrics, University Clinics Tuebingen, Tuebingen.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Augustin', 'Affiliation': 'Breast Center Ostbayern, Deggendorf.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kuemmel', 'Affiliation': 'Breast Center, Clinics Essen-Mitte, Essen.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Braun', 'Affiliation': 'Rotkreuz Clinics Munich Breast Center, Munich.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Potenberg', 'Affiliation': 'Department of Oncology Evangelical Waldkrankenhaus Berlin, Berlin.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kohls', 'Affiliation': 'Department of Gynecology and Obstetrics, Evangelical Hospital, Ludwigsfelde.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Krauss', 'Affiliation': 'Department of Gynecology and Obstetrics, University Clinics RWTH, Aachen.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stefek', 'Affiliation': 'Breast Center, Evangelical Hospital Johanniter, Stendal.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schumacher', 'Affiliation': 'Breast Center, St. Elisabeth Hospital Cologne, Cologne.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Forstbauer', 'Affiliation': 'Oncology Practice Network, Troisdorf.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Reimer', 'Affiliation': 'Department of Gynecology and Obstetrics, University Clinics Rostock, Suedstadt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fischer', 'Affiliation': 'Breast Center, Evangelical Hospital Gelsenkirchen, Gelsenkirchen.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Liedtke', 'Affiliation': 'Department of Gynecology and Obstetrics, University Clinics Schleswig-Holstein/Campus Luebeck, Luebeck; Charite Berlin.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wuerstlein', 'Affiliation': 'Breast Center, Department of Gynecology and Obstetrics, University of Munich (LMU) and CCCLMU, Munich.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': 'Palleos Healthcare, Statistics, Wiesbaden, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kates', 'Affiliation': 'West German Study Group GmbH, Moenchengladabach.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kreipe', 'Affiliation': 'University of Cologne, Cologne.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'West German Study Group GmbH, Moenchengladabach; Breast Center, Department of Gynecology and Obstetrics, University of Munich (LMU) and CCCLMU, Munich.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx494']
2313,19275849,Simulation training in laparoscopy using a computerized physical reality simulator.,"OBJECTIVE
To describe a new simulator, SurgicalSIM LTS, and summarize our preliminary experience with system.
METHODS
LTS was evaluated in 3 studies: (1) 124 participants from 3 Canadian universities: 13 students; 30 residents, fellows, attendings from surgery; 59 gynecologists; 22 urologists were classified based on laparoscopic experience as novice, intermediate, competent, or expert. All were tested on the LTS. Seventy-four were tested on the LTS and MISTELS (McGill Inanimate System for Training and Evaluation of Laparoscopic Skills). Participants completed a satisfaction questionnaire. (2) Twenty-five international gynecologists in-training at Kiel Gynaecologic Endoscopy Center, and 15 students from the center pretested on LTS underwent voluntary additional trials and posttesting. (3) Seventeen experienced laparoscopic surgeons from 3 specialties were recruited to perform on randomly assigned simulators involving 5 commercial, computer-based systems. The surgeons practiced repetitively for 1.5 days. Efficient, error-free performance was measured and proficiency score formulas were developed.
RESULTS
Study A: LTS showed a good correlation with level of experience (P=0.000) and MISTELS (0.79). Satisfaction: LTS vs MISTELS 79.9 vs 70.4 (P=0.012). Study B: Posttest scores were significantly better in all tasks for both groups, P<0.0001. Group mean scores with < or =5 trials were significantly better than with 2 or 3 trials (P<0.012, P<0.018). Study C: LTS had the highest effectiveness rating of the 5 simulators.
CONCLUSIONS
A new computerized physical reality simulator can be used to assess/train laparoscopic technical skills.",2008,"Group mean scores with < or =5 trials were significantly better than with 2 or 3 trials (P<0.012, P<0.018).","['Seventy-four were tested on the LTS and MISTELS', '124 participants from 3 Canadian universities: 13 students; 30 residents, fellows, attendings from surgery; 59 gynecologists; 22 urologists were classified based on laparoscopic experience as novice, intermediate, competent, or expert', '3) Seventeen experienced laparoscopic surgeons from 3 specialties', '2) Twenty-five international gynecologists in-training at Kiel Gynaecologic Endoscopy Center, and 15 students from the center pretested on LTS underwent voluntary additional trials and posttesting']","['LTS', 'Simulation training']","['Efficient, error-free performance', 'satisfaction questionnaire']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist (occupation)'}, {'cui': 'C0260314', 'cui_str': 'Urologists'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",124.0,0.0526543,"Group mean scores with < or =5 trials were significantly better than with 2 or 3 trials (P<0.012, P<0.018).","[{'ForeName': 'Harrith M', 'Initials': 'HM', 'LastName': 'Hasson', 'Affiliation': 'University of New Mexico, Albuquerque, NM. drhasson@aol.com'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2314,19275854,Laparoscopic gastric bypass for morbid obesity-a randomized controlled trial comparing two gastrojejunal anastomosis techniques.,"OBJECTIVES
We present a randomized controlled trial of laparoscopic gastric bypass comparing 2 techniques of gastrojejunostomy in patients with morbid obesity.
METHODS
Eighty consecutive patients underwent laparoscopic Roux-en-Y gastric bypass between September 2005 and August 2006. Patients were randomly assigned to 2 groups by the use of sealed envelopes. In group A, the gastrojejunal anastomosis was performed with a 21-mm circular-stapler, and in group B, this anastomosis was performed with a 45-mm linear-stapler. The rest of the procedure was identical in both groups. Variables evaluated were complications involving the gastrojejunostomy, operative time, length of stay, and percentage of excess weight loss.
RESULTS
Both groups were similar in age and body mass index. No patients experienced leakage or gastrojejunal anastomosis fistula, but group A patients had a more frequent stricture rate (P<0.05). Operative time and hospital stay were comparable in both groups (P>0.05). Percentage excess weight loss at one year following surgery was satisfactory in both groups, without a statistically significant difference (P>0.05).
CONCLUSION
Gastrojejunal anastomosis does not seem to be a critical factor in excess weight loss for morbidly obese patients who underwent laparoscopic gastric bypass. The 2 techniques used in this experience are safe and effective; however, the 45-mm liner-stapler is preferable because it has a lower stricture rate.",2008,"No patients experienced leakage or gastrojejunal anastomosis fistula, but group A patients had a more frequent stricture rate (P<0.05).","['Eighty consecutive patients underwent laparoscopic Roux-en-Y gastric bypass between September 2005 and August 2006', 'morbidly obese patients who underwent laparoscopic gastric bypass', 'patients with morbid obesity']","['laparoscopic gastric bypass', 'Laparoscopic gastric bypass', 'Gastrojejunal anastomosis']","['leakage or gastrojejunal anastomosis fistula', 'complications involving the gastrojejunostomy, operative time, length of stay, and percentage of excess weight loss', 'Percentage excess weight loss', 'Operative time and hospital stay', 'frequent stricture rate']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}]","[{'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}]","[{'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0399839', 'cui_str': 'Gastrojejunostomy'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",80.0,0.0350534,"No patients experienced leakage or gastrojejunal anastomosis fistula, but group A patients had a more frequent stricture rate (P<0.05).","[{'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Leyba', 'Affiliation': 'Universidad Central de Venezuela, Caracus, Venezuela. jlleyba@yahoo.es'}, {'ForeName': 'Salvador Navarrete', 'Initials': 'SN', 'LastName': 'Llopis', 'Affiliation': ''}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Isaac', 'Affiliation': ''}, {'ForeName': 'Salvador Navarrete', 'Initials': 'SN', 'LastName': 'Aulestia', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bravo', 'Affiliation': ''}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Obregon', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2315,31606234,Time to Reconsider Calcium-Based Phosphate Binders in Dialysis? A Call for a Well-Designed Randomized Controlled Trial.,,2020,,[],['Reconsider Calcium-Based Phosphate Binders'],[],[],"[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}]",[],,0.109219,,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': 'Rocky Mountain Regional VA Medical Center, University of Colorado Anschutz Medical Campus, Aurora, CO. Electronic address: anna.jovanovich@cuanschutz.edu.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.08.008']
2316,31618132,Clinicogenomic Radiotherapy Classifier Predicting the Need for Intensified Locoregional Treatment After Breast-Conserving Surgery for Early-Stage Breast Cancer.,"PURPOSE
Most patients with early-stage breast cancer are treated with adjuvant radiotherapy (RT) after breast-conserving surgery (BCS) to prevent locoregional recurrence (LRR). However, no genomic tools are used currently to select the optimal RT strategy.
METHODS
We profiled the transcriptome of primary tumors on a clinical grade assay from the SweBCG91-RT trial, in which patients with node-negative breast cancer were randomly assigned to either whole-breast RT after BCS or no RT. We derived a new classifier, Adjuvant Radiotherapy Intensification Classifier (ARTIC), comprising 27 genes and patient age, in three publicly available cohorts, then independently validated ARTIC for LRR in 748 patients in SweBCG91-RT. We also compared previously published genomic signatures for ability to predict benefit from RT in SweBCG91-RT.
RESULTS
ARTIC was highly prognostic for LRR in patients treated with RT (hazard ratio [HR], 3.4; 95% CI, 2.0 to 5.9; P < .001) and predictive of RT benefit ( P interaction = .005). Patients with low ARTIC scores had a large benefit from RT (HR, 0.33 [95% CI, 0.21 to 0.52], P < .001; 10-year cumulative incidence of LRR, 6% v 21%), whereas those with high ARTIC scores benefited less from RT (HR, 0.73 [95% CI, 0.44 to 1.2], P = .23; 10-year cumulative incidence of LRR, 25% v 32%). In contrast, none of the eight previously published signatures were predictive of benefit from RT in SweBCG91-RT.
CONCLUSION
ARTIC identified women with a substantial benefit from RT as well as women with a particularly elevated LRR risk in whom whole-breast RT was not sufficiently effective and, thus, in whom intensified treatment strategies such as tumor-bed boost, and possibly regional nodal RT, should be considered. To our knowledge, ARTIC is the first classifier validated as predictive of benefit from RT in a phase III clinical trial with patients randomly assigned to receive or not receive RT.",2019,"Patients with low ARTIC scores had a large benefit from RT (HR, 0.33","['patients with node-negative breast cancer', 'Early-Stage Breast Cancer', '748 patients in SweBCG91-RT', 'patients with early-stage breast cancer']","['whole-breast RT after BCS or no RT', 'adjuvant radiotherapy (RT) after breast-conserving surgery (BCS', 'Clinicogenomic Radiotherapy Classifier']",['predictive of RT benefit'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],748.0,0.0539045,"Patients with low ARTIC scores had a large benefit from RT (HR, 0.33","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'S Laura', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'PFS Genomics, Vancouver, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Fishbane', 'Affiliation': 'Decipher Biosciences, Vancouver, Canada.'}, {'ForeName': 'Elai', 'Initials': 'E', 'LastName': 'Davicioni', 'Affiliation': 'Decipher Biosciences, Vancouver, Canada.'}, {'ForeName': 'Shuang G', 'Initials': 'SG', 'LastName': 'Zhao', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hartman', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Corey W', 'Initials': 'CW', 'LastName': 'Speers', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00761']
2317,32430775,"Comparison of clinical efficacy and patient acceptance of interdental brush and silicone coated interdental pick: a randomized split-mouth, prospective clinical trial.","OBJECTIVES
The aim of this split-mouth, prospective controlled study was to compare the effects of two different interdental devices on clinical plaque elimination, gingival bleeding and patient acceptance and comfort.
MATERIALS AND METHODS
Thirty participants who had been diagnosed with gingivitis were included in the study. After professional oral prophylaxis and a 3-day washout period, patients were advised to use two test devices (TePe Interdental Brushes Original and TePe EasyPick™, Malmö, Sweden) according to instructions. The plaque index (Turesky modification of the Quigley and Hein Index) and bleeding index (Papillary Bleeding Index) were recorded at baseline and after 2 weeks. Patient satisfaction and comfort were assessed with a questionnaire.
RESULTS
Both of the tested devices improved the plaque and bleeding index scores. There were no differences between the two sides in terms of time-dependent changes. The patients felt more satisfied with the cleansing capacity and more comfortable with the use of SCIP compared with IDB (p = 0.001). Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
CONCLUSION
The clinical efficiency of the tested interdental devices was similar in terms of removing plaque and decreasing bleeding. However, SCIP were found to be more comfortable and preferable to IDB.
CLINICAL RELEVANCE
The silicone coated interdental picks showed similar effects on plaque removal as interdental brushes and superiority in terms of ease to use than interdental brushes.",2020,"Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
",['Thirty participants who had been diagnosed with gingivitis were included in the study'],['interdental brush and silicone coated interdental pick'],"['plaque and bleeding index scores', 'clinical plaque elimination, gingival bleeding and patient acceptance and comfort', 'plaque removal', 'plaque index (Turesky modification of the Quigley and Hein Index) and bleeding index (Papillary Bleeding Index', 'Pain sensation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",30.0,0.0542861,"Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
","[{'ForeName': 'Gülbahar', 'Initials': 'G', 'LastName': 'Ustaoğlu', 'Affiliation': 'Department of Periodontology, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ercan', 'Affiliation': 'Department of Periodontology, Çanakkale Onsekiz Mart University, Çanakkale, Turkey. esraercan82@gmail.com.'}, {'ForeName': 'Kerem Çağlar', 'Initials': 'KÇ', 'LastName': 'Gümüş', 'Affiliation': 'Department of Periodontology, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03293-6']
2318,18765042,Virtual reality and computer-enhanced training devices equally improve laparoscopic surgical skill in novices.,"BACKGROUND
The study aim was to compare the effectiveness of virtual reality and computer-enhanced videoscopic training devices for training novice surgeons in complex laparoscopic skills.
METHODS
Third-year medical students received instruction on laparoscopic intracorporeal suturing and knot tying and then underwent a pretraining assessment of the task using a live porcine model. Students were then randomized to objectives-based training on either the virtual reality (n=8) or computer-enhanced (n=8) training devices for 4 weeks, after which the assessment was repeated.
RESULTS
Posttraining performance had improved compared with pretraining performance in both task completion rate (94% versus 18%; P<0.001*) and time [181+/-58 (SD) versus 292+/-24*]. Performance of the 2 groups was comparable before and after training. Of the subjects, 88% thought that haptic cues were important in simulators. Both groups agreed that their respective training systems were effective teaching tools, but computer-enhanced device trainees were more likely to rate their training as representative of reality (P<0.01).
CONCLUSIONS
Training on virtual reality and computer-enhanced devices had equivalent effects on skills improvement in novices. Despite the perception that haptic feedback is important in laparoscopic simulation training, its absence in the virtual reality device did not impede acquisition of skill.",2008,"RESULTS
Posttraining performance had improved compared with pretraining performance in both task completion rate (94% versus 18%; P<0.001*) and time [181+/-58 (SD) versus 292+/-24","['Third-year medical students received', 'novices']","['Virtual reality and computer-enhanced training devices', 'virtual reality (n=8) or computer-enhanced (n=8) training devices', 'instruction on laparoscopic intracorporeal suturing and knot tying and then underwent a pretraining assessment of the task using a live porcine model', 'virtual reality and computer-enhanced videoscopic training devices']","['pretraining performance in both task completion rate', 'laparoscopic surgical skill']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.0392824,"RESULTS
Posttraining performance had improved compared with pretraining performance in both task completion rate (94% versus 18%; P<0.001*) and time [181+/-58 (SD) versus 292+/-24","[{'ForeName': 'Prathima', 'Initials': 'P', 'LastName': 'Kanumuri', 'Affiliation': 'Baystate Medical Center, Department of Surgery, Tufts University School of Medicine, Springfield, Massachusetts 01199, USA.'}, {'ForeName': 'Sabha', 'Initials': 'S', 'LastName': 'Ganai', 'Affiliation': ''}, {'ForeName': 'Eyad M', 'Initials': 'EM', 'LastName': 'Wohaibi', 'Affiliation': ''}, {'ForeName': 'Ronald W', 'Initials': 'RW', 'LastName': 'Bush', 'Affiliation': ''}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Grow', 'Affiliation': ''}, {'ForeName': 'Neal E', 'Initials': 'NE', 'LastName': 'Seymour', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2319,31685555,Minimally invasive interval cytoreductive surgery: it's time for a randomized trial.,,2019,,[],['Minimally invasive interval cytoreductive surgery'],[],[],"[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}]",[],,0.0524414,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Melamed', 'Affiliation': 'Department of Obstetrics and Gynecology and Herbert Irving Comprehensive Cancer Center, Columbia University, New York Presbyterian Hospital, New York City, New York, USA.'}, {'ForeName': 'Jose Alejandro', 'Initials': 'JA', 'LastName': 'Rauh-Hain', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States jarauh@mdanderson.org.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000971']
2320,31714608,Improving timely access to food allergy care: A pragmatic controlled trial.,,2020,,[],[],[],[],[],[],,0.0896965,,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Prescilla', 'Initials': 'P', 'LastName': 'Perera', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Danchin', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Vic., Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Sung', 'Affiliation': ""Centre for Community Child Health, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Vic., Australia.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Stival', 'Affiliation': ""Clinical Epidemiology & Biostatistics Unit, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Peat', 'Affiliation': ""Centre for Community Child Health, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Molloy', 'Affiliation': ""Population Allergy, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Sharoan', 'Initials': 'S', 'LastName': 'Selvakumaran', 'Affiliation': ""Health Services Research Unit, Royal Children's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'Mimi L K', 'Initials': 'MLK', 'LastName': 'Tang', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Melbourne, Vic., Australia.'}]",Allergy,['10.1111/all.14105']
2321,32428066,Effect of an interdisciplinary intervention with motivational approach on exercise capacity in obese adolescents: a randomized controlled clinical trial.,"Objective To evaluate the effect of an interdisciplinary intervention with a motivational approach on exercise capacity and usual physical activity levels in overweight and obese adolescents. Methods This is a randomized, controlled clinical trial with single blinding of subjects. Adolescents aged 15 to 18 years with overweight and obesity (body mass index ≥ 85 percentile) were included. The adolescents were randomized into two groups: interdisciplinary intervention or control - traditional approach aiming at lifestyle modifications. The initial evaluations were carried out, including the cardiopulmonary exercise test and the physical activity level measurement by using the International Physical Activity Questionnaire and a pedometer. The evaluations were performed in two moments: time zero (time of inclusion in the study) and after 3 months (end of intervention). There were 12 sessions with weekly meetings. Results A total of 37 participants were included, 19 in the Intervention Group. There were no significant differences in the baseline demographic, anthropometric and physical activity characteristics between groups, with mean age of 17.3±1.0 years in the Control Group, and 16.8±0.9 years in the Intervention Group (p=0.14). The motivational intervention did not cause significant differences (p>0.05) in the comparison of the variables of exercise capacity and usual physical activity (questionnaire and pedometer) between groups. Conclusion The intervention with a motivational approach did not alter exercise capacity and levels of usual physical activity in overweight and obese adolescents. Clinical Trial Registry: NCT02455973 and REBEC: RBR-234nb5.",2020,The motivational intervention did not cause significant differences (p>0.05) in the comparison of the variables of exercise capacity and usual physical activity (questionnaire and pedometer) between groups.,"['overweight and obese adolescents', 'subjects', 'Adolescents aged 15 to 18 years with overweight and obesity (body mass index ≥ 85 percentile', 'obese adolescents', 'A total of 37 participants were included, 19 in the Intervention Group']","['interdisciplinary intervention with a motivational approach', 'RBR-234nb5', 'interdisciplinary intervention or control - traditional approach aiming at lifestyle modifications', 'interdisciplinary intervention with motivational approach']","['exercise capacity and levels of usual physical activity', 'exercise capacity and usual physical activity levels', 'baseline demographic, anthropometric and physical activity characteristics', 'exercise capacity', 'exercise capacity and usual physical activity (questionnaire and pedometer']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",37.0,0.0502785,The motivational intervention did not cause significant differences (p>0.05) in the comparison of the variables of exercise capacity and usual physical activity (questionnaire and pedometer) between groups.,"[{'ForeName': 'Letiane Bueno', 'Initials': 'LB', 'LastName': 'Zanatta', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Heinzmann-Filho', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Fernanda Maria', 'Initials': 'FM', 'LastName': 'Vendrusculo', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Natália Evangelista', 'Initials': 'NE', 'LastName': 'Campos', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Margareth da Silva', 'Initials': 'MDS', 'LastName': 'Oliveira', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ana Maria Pandolfo', 'Initials': 'AMP', 'LastName': 'Feoli', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Andréia da Silva', 'Initials': 'ADS', 'LastName': 'Gustavo', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]","Einstein (Sao Paulo, Brazil)",['10.31744/einstein_journal/2020ao5268']
2322,31553693,"High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008.","PURPOSE
The R2Pulm trial was conducted to evaluate the effect of busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI) on event-free survival (main end point) and overall survival, compared with standard chemotherapy with WLI in Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases.
METHODS
From 2000 to 2015, we enrolled patients younger than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases. Patients received chemotherapy with six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI) by randomized assignment. The analysis was conducted as intention to treat. The estimates of the hazard ratio (HR), 95% CI, and P value were corrected for the three previous interim analyses by the inverse normal method.
RESULTS
Of 543 potentially eligible patients, 287 were randomly assigned to VAI plus WLI (n = 143) or BuMel (n = 144). Selected patients requiring radiotherapy to an axial primary site were excluded from randomization to avoid excess organ toxicity from interaction between radiotherapy and busulfan. Median follow-up was 8.1 years. We did not observe any significant difference in survival outcomes between treatment groups. Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16). For overall survival, the HR was 1.00 (95% CI, 0.70 to 1.44; P = .99). Four patients died as a result of BuMel-related toxicity, and none died after VAI plus WLI. Significantly more patients in the BuMel arm experienced severe acute toxicities than in the VAI plus WLI arm.
CONCLUSION
In ES with pulmonary or pleural metastases, there is no clear benefit from BuMel compared with conventional VAI plus WLI.",2019,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16).","['Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases', 'From 2000 to 2015, we enrolled patients older than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases', 'Ewing Sarcoma', 'Selected patients requiring radiotherapy to an axial primary site', 'Of 543 potentially eligible patients']","['standard chemotherapy with WLI', 'busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI', 'Standard Chemotherapy and Lung Radiation', 'radiotherapy and busulfan', 'chemotherapy', 'High-Dose Chemotherapy', 'BuMel', 'vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI', 'VAI plus WLI']","['severe acute toxicities', 'Event-free survival', 'survival outcomes', 'overall survival', 'hazard ratio (HR']","[{'cui': 'C0553580', 'cui_str': ""Ewing's Tumor""}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0153678', 'cui_str': 'Secondary malignant neoplasm of pleura (disorder)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",287.0,0.239424,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16).","[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Dirksen', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Brennan', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Centre Oscar Lambret, Lille; and Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Cozic', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van den Berg', 'Affiliation': 'Emma Children Hospital - Amsterdam University Medical Centres, Amsterdam, the Netherlands.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Bhadri', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Brichard', 'Affiliation': 'Cliniques Universitaires Saint Luc, Brussels, Belgium.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Claude', 'Affiliation': 'Centre Léon Bérard, Lyon; France.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Craft', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Amler', 'Affiliation': 'Westfalian Wilhelms University Muenster, Muenster; and Friedrich- Loeffler Institute, Greifswald-Insel Riems, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gaspar', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldsby', 'Affiliation': ""University of California San Francisco Benioff Children's Hospital, San Francisco, CA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gorlick', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Holcombe E', 'Initials': 'HE', 'LastName': 'Grier', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Guinbretiere', 'Affiliation': 'Hôpital René-Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hauser', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hjorth', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Janeway', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Juergens', 'Affiliation': 'Universitaetskinderklinik Muenster, Muenster, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Judson', 'Affiliation': 'Royal Marsden Foundation NHS Trust, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Krailo', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jarmila', 'Initials': 'J', 'LastName': 'Kruseova', 'Affiliation': 'Charles University Prague, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuehne', 'Affiliation': ""University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Lervat', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Lessnick', 'Affiliation': ""Nationwide Children's Hospital and The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Lewis', 'Affiliation': 'University of Leeds, Liverpool, United Kingdom.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Linassier', 'Affiliation': 'Centre Hospitalier Universitaire, Tours, France.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Marec-Berard', 'Affiliation': 'Institute of Pediatric Onco-Haematology, Lyon, France.'}, {'ForeName': 'Neyssa', 'Initials': 'N', 'LastName': 'Marina', 'Affiliation': 'Five Time Therapeutics, South San Francisco, CA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Morland', 'Affiliation': ""Birmingham Women and Children's Hospital, Birmingham, United Kingdom.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pacquement', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paulussen', 'Affiliation': 'Witten/Herdecke University, Datteln, Germany.'}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'University of California Davis, Sacramento, CA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ranft', 'Affiliation': 'Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Gwénaël', 'Initials': 'G', 'LastName': 'Le Teuff', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'University College Hospital, London, United Kingdom.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Womer', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Oberlin', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00915']
2323,31280058,Time-dependent effects of psychosocial stress on the contextualization of neutral memories.,"Memories about stressful experiences need to be both specific and generalizable to adequately guide future behavior. Memory strength is influenced by emotional significance, and contextualization (i.e., encoding experiences with their contextual details) enables selective context-dependent retrieval and protects against overgeneralization. The current randomized-controlled study investigated how the early and late phase of the endogenous stress response affects the contextualization of neutral and negative information. One hundred healthy male participants were randomly divided into three experimental groups that performed encoding either 1) without stress (control), 2) immediately after acute stress (early) or 3) two hours after acute stress (late). Stress was induced via the Trier Social Stress Test and salivary alpha-amylase and cortisol levels were measured throughout the experiment. In the Memory Contextualization Task, neutral and angry faces (items) were depicted against unique context pictures during encoding. During testing 24 h later, context-dependent recognition memory of the items was assessed by presenting these in either congruent or incongruent contexts (relative to encoding). Multilevel analyses revealed that neutral information was more contextualized when encoding took place two hours after psychosocial stress, than immediately after the stressor. Results suggest that the late effects in the unique, time-dependent sequence of a healthy endogenous stress response, could complement reduced contextualization immediately after stress. The contextualization of negative information was not influenced by psychosocial stress, as opposed to earlier reported effects of exogenous hydrocortisone administration. An imbalance between the early and late effects of the endogenous stress response could increase vulnerability for stress-related psychopathology.",2019,"The contextualization of negative information was not influenced by psychosocial stress, as opposed to earlier reported effects of exogenous hydrocortisone administration.",['One hundred healthy male participants'],[],"['Memory Contextualization Task, neutral and angry faces (items', 'Trier Social Stress Test and salivary alpha-amylase and cortisol levels', 'contextualization of neutral memories', 'Memory strength']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",100.0,0.0151868,"The contextualization of negative information was not influenced by psychosocial stress, as opposed to earlier reported effects of exogenous hydrocortisone administration.","[{'ForeName': 'Milou S C', 'Initials': 'MSC', 'LastName': 'Sep', 'Affiliation': 'Brain Research and Innovation Centre, Ministry of Defence, Utrecht, the Netherlands; Department of Translational Neuroscience, UMC Utrecht Brain Center, Utrecht University, Utrecht, the Netherlands. Electronic address: m.s.c.sep-2@umcutrecht.nl.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'van Ast', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Gorter', 'Affiliation': 'Brain Research and Innovation Centre, Ministry of Defence, Utrecht, the Netherlands.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Joëls', 'Affiliation': 'Department of Translational Neuroscience, UMC Utrecht Brain Center, Utrecht University, Utrecht, the Netherlands; University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Elbert', 'Initials': 'E', 'LastName': 'Geuze', 'Affiliation': 'Brain Research and Innovation Centre, Ministry of Defence, Utrecht, the Netherlands; Department of Psychiatry, UMC Utrecht Brain Center, Utrecht University, Utrecht, the Netherlands.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.06.021']
2324,18765046,Laparoscopically assisted vaginal hysterectomy versus vaginal hysterectomy for enlarged uterus.,"OBJECTIVES
To compare the surgical and immediate postoperative outcomes for vaginal hysterectomy (VH) with those for laparoscopically assisted vaginal hysterectomy (LAVH) in patients with enlarged myomatous uterus.
METHODS
Eighty women requiring hysterectomy for an enlarged myomatous uterus were randomly allocated into 2 treatment arms: VH (n=40) and LAVH (n=40). The randomization procedure was based on a computer-generated list. The primary outcome was a comparison of the discharge times between the 2 procedures. Continuous outcome variables were analyzed using the Student t test. Discrete variables were analyzed with the chi-square test or Fisher's exact test. P<0.05 was considered statistically significant.
RESULTS
The mean discharge time was longer for LAVH than for VH (72+/-4.2 vs 48+/-2.6 h; P=0.00). VH resulted in shorter times for paralytic ileus (19+/-3 vs 26+/-3 h; P=0.00) and surgery (71+/-3 vs 129+/-7 min; P=0.00). The intraoperative blood loss was less with VH (186.0+/-52 vs 362.7+/-65 mL; P=0.00). No intraoperative complications occurred, and no patient was returned to the operative theater in either group.
CONCLUSIONS
Several surgical and immediate postoperative outcomes were significantly better in the VH group than in the LAVH group. However, further controlled prospective studies are required for identifying the best approach for hysterectomy in patients with enlarged uterus.",2008,Several surgical and immediate postoperative outcomes were significantly better in the VH group than in the LAVH group.,"['patients with enlarged myomatous uterus', 'Eighty women requiring hysterectomy for an enlarged myomatous uterus', 'patients with enlarged uterus']","['Laparoscopically assisted vaginal hysterectomy versus vaginal hysterectomy', 'laparoscopically assisted vaginal hysterectomy (LAVH', 'LAVH', 'VH', 'vaginal hysterectomy (VH']","['intraoperative complications', 'mean discharge time', 'paralytic ileus', 'discharge times', 'Several surgical and immediate postoperative outcomes', 'intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0020700', 'cui_str': 'Colpohysterectomy'}]","[{'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030446', 'cui_str': 'Paralytic Ileus'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",80.0,0.144836,Several surgical and immediate postoperative outcomes were significantly better in the VH group than in the LAVH group.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sesti', 'Affiliation': 'Section of Gynaecology and Obstetrics, Department of Surgery, School of Medicine, Tor Vergata University Hospital, Viale Oxford 81, Rome, Italy. Francesco.Sesti@uniroma2.it'}, {'ForeName': 'Velia', 'Initials': 'V', 'LastName': 'Ruggeri', 'Affiliation': ''}, {'ForeName': 'Adalgisa', 'Initials': 'A', 'LastName': 'Pietropolli', 'Affiliation': ''}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Piccione', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2325,31709557,Laboratory analogue investigation of defusion and reappraisal strategies in the context of symbolically generalized avoidance.,"The present study examined and compared the effects of 2 analogues of cognitive treatments-cognitive defusion and cognitive reappraisal-on symbolically generalized avoidance established using a basic behavioral laboratory paradigm. This back-translation design contributes to the development and validation of principle-based definitions of the applied constructs of defusion and reappraisal. Eighty-eight participants first underwent basic laboratory procedures designed to establish symbolically generalized avoidance in response to an arbitrary stimulus (a nonsense word). Participants were then randomized to defusion, reappraisal, or control conditions. The response variables were (a) equivalence responding-indicative of the trained relational network and analogous to the cognitive content responsible for symbolic generalization-and (b) avoidance-the behavioral impact of symbolic generalization. A between-groups analysis revealed that defusion and reappraisal significantly increased the odds of nonavoidance responding. Discrete-time survival mediation analyses provided preliminary support for the classification of defusion as a functional context intervention and reappraisal as a relational context intervention.",2019,A between-groups analysis revealed that defusion and reappraisal significantly increased the odds of nonavoidance responding.,[],['cognitive treatments-cognitive defusion and cognitive reappraisal'],[],[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],88.0,0.0218997,A between-groups analysis revealed that defusion and reappraisal significantly increased the odds of nonavoidance responding.,"[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Donati', 'Affiliation': 'Georgia State University.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Masuda', 'Affiliation': ""University of Hawai'i at Mānoa.""}, {'ForeName': 'L Ward', 'Initials': 'LW', 'LastName': 'Schaefer', 'Affiliation': 'Georgia State University.'}, {'ForeName': 'Lindsey L', 'Initials': 'LL', 'LastName': 'Cohen', 'Affiliation': 'Georgia State University.'}, {'ForeName': 'Erin B', 'Initials': 'EB', 'LastName': 'Tone', 'Affiliation': 'Georgia State University.'}, {'ForeName': 'Dominic J', 'Initials': 'DJ', 'LastName': 'Parrott', 'Affiliation': 'Georgia State University.'}]",Journal of the experimental analysis of behavior,['10.1002/jeab.550']
2326,31872398,Rehabilitation of ADHD children by sport intervention: a Tunisian experience.,"INTRODUCTION
Childhood attention-deficit/hyperactivity disorder is associated with impairment across multiple domains, including social, familial, emotional and academic functioning. Available therapies, and in particular medical treatment, fail to produce improvement in this impairment. In this context, interest has grown in physical activity and exercise as potential interventions for the treatment of children with ADHD.
AIM
The present study investigates the effect of a recreational swimming program on cognitives functions on Tunisian children with attention deficit hyperactivity disorder (ADHD).
METHODS
The study recruited school children aged 9 to 12 years (n total = 40) with diagnosis of ADHD. They were randomly assigned into exercise or control groups. Neuropsychological tasks; the complex figure of Rey (ROCF), the stroop test and the Hayling test were assessed before and after the exercise program.
RESULTS
The results indicates that there were significant improvements in memory accuracy (p=0,000), selective attention (p=0,000), and inhibition process (p=0,000), in experimental group compared with the control group after the intervention. In the post-program, children experienced an overall shortening of task execution times with fewer errors of omissions. They also made fewer errors in interference situations, signaling better cognitive functioning. Conclusion These findings suggest that a recreational swimming program may have positive implications for cognitive function and may provide preliminary support for alternative therapeutic interventions that can be used by researchers, parents, educators, and clinicians and they support that reinforcement approved by recreational program can normalize cognitive deficiencies in children with ADHD.",2019,"The results indicates that there were significant improvements in memory accuracy (p=0,000), selective attention (p=0,000), and inhibition process (p=0,000), in experimental group compared with the control group after the intervention.","['school children aged 9 to 12 years (n total = 40) with diagnosis of ADHD', 'children with ADHD', 'Tunisian children with attention deficit hyperactivity disorder (ADHD']","['sport intervention', 'recreational swimming program']","['memory accuracy (p=0,000), selective attention (p=0,000), and inhibition process', 'overall shortening of task execution times', 'complex figure of Rey (ROCF), the stroop test and the Hayling test']","[{'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention (finding)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0246815,"The results indicates that there were significant improvements in memory accuracy (p=0,000), selective attention (p=0,000), and inhibition process (p=0,000), in experimental group compared with the control group after the intervention.","[{'ForeName': 'Soukaina', 'Initials': 'S', 'LastName': 'Hattabi', 'Affiliation': ''}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Bouallegue', 'Affiliation': ''}, {'ForeName': 'Houda', 'Initials': 'H', 'LastName': 'Ben Yahya', 'Affiliation': ''}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Bouden', 'Affiliation': ''}]",La Tunisie medicale,[]
2327,29674341,Contrast-Induced Acute Kidney Injury in the PRESERVE Trial: Lessons Learned.,,2018,,['Trial'],[],[],[],[],[],,0.0749604,,"[{'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Siew', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt Center for Kidney Disease and Integrated Program for AKI Research, Vanderbilt University Medical Center, Nashville, Tennessee; edward.siew@vanderbilt.edu.'}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': 'Division of Nephrology, Department of Medicine, and.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.01060118']
2328,31522785,A randomized-controlled trial of arginine infusion in severe sepsis on microcirculation and metabolism.,"BACKGROUND & AIMS
Sepsis is hypothesized as an arginine deficient state, with lack of nitric oxide (NO) for adequate microcirculation and local perfusion. This study aimed to investigate if prolonged (72-h) intravenous l-arginine administration in sepsis patients improves microcirculation. Secondly, effects on arginine and protein metabolism, and organ function were studied.
METHODS
Critically ill patients with a diagnosis of septic shock participated in a long-term (72 h) randomized double-blind placebo-controlled parallel-group study. l-arginine-HCl (1.2 μmol kg -1 min -1 ; n = 9) or l-alanine (isocaloric control: 2.4 μmol kg -1 min -1 ; n = 9) was continuously infused. Primary study outcome was microcirculation, assessed as gastric mucosal perfusion by gastric tonometry (P r-a CO 2 gap) and skin perfusion by Laser Doppler flowmetry. Secondary endpoints were whole body (WB) arginine and protein metabolism, organ function and clinical outcomes. We measured global hemodynamics continuously for safety monitoring. Statistical analyses were performed by mixed model for repeated measures with treatment by time interaction as estimate for between-group difference.
RESULTS
P r-a CO 2 increased only in the l-arginine group (p = 0.006), without a significant between-group difference (p = 0.17). We found no significant differences in skin perfusion parameters. l-arginine infusion resulted in a larger increase of plasma arginine and ornithine concentrations (p < 0.01), WB (endogenous) arginine appearance (p < 0.001), WB NO synthesis (p = 0.027) and WB arginine to urea conversion (p < 0.001) than infusion of l-alanine. We found no effect on global hemodynamics, and protein metabolism by l-arginine infusion. Organ function parameters were unaffected, except for a significant difference between groups in intra-abdominal pressure over time (p = 0.029).
CONCLUSIONS
Prolonged intravenous l-arginine administration does not improve local perfusion and organ function despite an increase in WB NO synthesis. Administration is safe with regard to global hemodynamics, but the observed increase in P r-a CO 2 and intra-abdominal pressure warrants careful application of l-arginine infusion and further research, especially in the early stage of septic shock.",2020,"l-arginine infusion resulted in a larger increase of plasma arginine and ornithine concentrations (p < 0.01), WB (endogenous) arginine appearance (p < 0.001), WB NO synthesis (p = 0.027) and WB arginine to urea conversion (p < 0.001) than infusion of l-alanine.","['Critically ill patients with a diagnosis of septic shock participated in a long-term (72\xa0h) randomized', 'severe sepsis on microcirculation and metabolism', 'sepsis patients improves microcirculation']","['arginine infusion', 'double-blind placebo', 'l-arginine-HCl', 'l-alanine (isocaloric control', 'prolonged (72-h) intravenous l-arginine']","['local perfusion and organ function', 'plasma arginine and ornithine concentrations', 'gastric mucosal perfusion by gastric tonometry (P r-a CO 2 gap) and skin perfusion by Laser Doppler flowmetry', 'WB NO synthesis', 'skin perfusion parameters', 'intra-abdominal pressure over time', 'WB (endogenous) arginine appearance', 'whole body (WB) arginine and protein metabolism, organ function and clinical outcomes', 'global hemodynamics, and protein metabolism', 'Organ function parameters', 'arginine and protein metabolism, and organ function']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0029277', 'cui_str': 'Ornithine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0162520', 'cui_str': 'Laser-Doppler Flowmetry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.297496,"l-arginine infusion resulted in a larger increase of plasma arginine and ornithine concentrations (p < 0.01), WB (endogenous) arginine appearance (p < 0.001), WB NO synthesis (p = 0.027) and WB arginine to urea conversion (p < 0.001) than infusion of l-alanine.","[{'ForeName': 'Yvette C', 'Initials': 'YC', 'LastName': 'Luiking', 'Affiliation': 'Maastricht University Medical Center+, Department of Surgery and Intensive Care Medicine, P.O. Box 5800, 6202 AZ Maastricht, the Netherlands; NUTRIM School for Nutrition and Translational Research in Metabolism, P.O. Box 616, 6200 MD Maastricht, the Netherlands. Electronic address: yc.luiking@ctral.org.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Poeze', 'Affiliation': 'Maastricht University Medical Center+, Department of Surgery and Intensive Care Medicine, P.O. Box 5800, 6202 AZ Maastricht, the Netherlands; NUTRIM School for Nutrition and Translational Research in Metabolism, P.O. Box 616, 6200 MD Maastricht, the Netherlands.'}, {'ForeName': 'Nicolaas E', 'Initials': 'NE', 'LastName': 'Deutz', 'Affiliation': 'NUTRIM School for Nutrition and Translational Research in Metabolism, P.O. Box 616, 6200 MD Maastricht, the Netherlands; Maastricht University, Department of Surgery, Maastricht P.O. Box 616, 6200 MD Maastricht, the Netherlands.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.08.013']
2329,31831143,"Corrigendum to ""Effect of lurasidone vs olanzapine on neurotrophic biomarkers in unmedicated schizophrenia: A randomized controlled trial"" [J. Psychiatr. Res. 112 (2019) 1-6].",,2020,,"['unmedicated schizophrenia', '112']",['lurasidone vs olanzapine'],['neurotrophic biomarkers'],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C4704801', 'cui_str': 'Neurotrophic'}]",,0.075146,,"[{'ForeName': 'Monalisa', 'Initials': 'M', 'LastName': 'Jena', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India. Electronic address: pharm_monalisa@aiimsbhubaneswar.edu.in.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Ranjan', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Patna, India.'}, {'ForeName': 'Biswa Ranjan', 'Initials': 'BR', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Santanu', 'Initials': 'S', 'LastName': 'Nath', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Pallabi', 'Initials': 'P', 'LastName': 'Sahu', 'Affiliation': 'Department of Psychiatry, KIMS, Bhubaneswar, India.'}, {'ForeName': 'Bikash Ranjan', 'Initials': 'BR', 'LastName': 'Meher', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Maiti', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.11.019']
2330,32427667,Racial Differences in the Influence of Health Care System Factors on Informal Support for Cancer Care Among Black and White Breast and Lung Cancer Survivors.,"This retrospective, secondary qualitative analysis investigates whether health system factors influence social support among Black and white breast and lung cancer survivors and racial differences in support. These data come from race- and cancer-stratified focus groups (n = 6) and interviews (n = 2) to inform a randomized controlled trial utilizing antiracism and community-based participatory research approaches. Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted. Resources within individual support networks reflect broader sociostructural factors. Reliance on family/friends to fill gaps in cancer care may exacerbate racial disparities.",2020,"Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted.","['Cancer Care', 'Black and White Breast and Lung Cancer Survivors', 'Black and white breast and lung cancer survivors']",['health system factors influence social support'],[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",[],6.0,0.0371642,"Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted.","[{'ForeName': 'Katrina R', 'Initials': 'KR', 'LastName': 'Ellis', 'Affiliation': 'Greensboro Health Disparities Collaborative, North Carolina (Drs Ellis, Black, Baker, Davis, Doost, Lightfoot, Samuel, Schaal, and Eng and Mss Cothern, Goestch, Griesemer, Guerrab, Padilla, and Yongue); School of Social Work, University of Michigan, Ann Arbor (Dr Ellis); College of Health and Human Performance, East Carolina University, Greenville (Dr Black); Public Health Studies Program, Elon University, North Carolina (Dr Baker); School of Medicine, Washington University, St Louis, Missouri (Dr Davis); Departments of Health Behavior (Mss Griesemer and Guerrab and Drs Lightfoot and Eng) and Health Policy and Management (Ms Padilla and Dr Samuel), University of North Carolina, Chapel Hill; Center for Health Promotion and Disease Prevention, University of North Carolina (Dr Lightfoot); The Partnership Project, Inc, Greensboro, North Carolina (Dr Schaal); and Department of Public Health Education, University of North Carolina at Greensboro (Ms Yongue).'}, {'ForeName': 'Kristin Z', 'Initials': 'KZ', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cothern', 'Affiliation': ''}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Doost', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Goestch', 'Affiliation': ''}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Griesemer', 'Affiliation': ''}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Guerrab', 'Affiliation': ''}, {'ForeName': 'Alexandra F', 'Initials': 'AF', 'LastName': 'Lightfoot', 'Affiliation': ''}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Padilla', 'Affiliation': ''}, {'ForeName': 'Cleo A', 'Initials': 'CA', 'LastName': 'Samuel', 'Affiliation': ''}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Schaal', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yongue', 'Affiliation': ''}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Eng', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000264']
2331,18435881,Postoperative pain after laparoscopic ventral hernia repair: a prospective comparison of sutures versus tacks.,"BACKGROUND AND OBJECTIVES
Mesh fixation in laparoscopic ventral hernia repair typically involves the use of tacks, transabdominal permanent sutures, or both of these. We compared postoperative pain after repair with either of these 2 methods.
METHODS
Patients undergoing laparoscopic ventral hernia repair at the Mount Sinai Medical Center were prospectively enrolled in the study. They were sorted into 2 groups (1) those undergoing hernia repairs consisting primarily of transabdominal suture fixation and (2) those undergoing hernia repairs consisting primarily of tack fixation. The patients were not randomized. The technique of surgical repair was based on surgeon preference. A telephone survey was used to follow-up at 1 week, 1 month, and 2 months postoperatively.
RESULTS
From 2004 through 2005, 50 patients were enrolled in the study. Twenty-nine had hernia repair primarily with transabdominal sutures, and 21 had repair primarily with tacks. Both groups had similar average age, BMI, hernia defect size, operative time, and postoperative length of stay. Pain scores at 1 week, 1 month, and 2 months were similar. Both groups also had similar times to return to work and need for narcotic pain medication.
CONCLUSIONS
Patients undergoing laparoscopic ventral hernia repair with primarily transabdominal sutures or tacks experience similar postoperative pain. The choice of either of these fixation methods during surgery should not be based on risk of postoperative pain.",2008,"Pain scores at 1 week, 1 month, and 2 months were similar.","['Patients undergoing laparoscopic ventral hernia repair at the Mount Sinai Medical Center were prospectively enrolled in the study', 'From 2004 through 2005, 50 patients were enrolled in the study', 'Twenty-nine had hernia repair primarily with transabdominal sutures, and 21 had repair primarily with tacks']","['sutures versus tacks', 'laparoscopic ventral hernia repair with primarily transabdominal sutures', 'hernia repairs consisting primarily of transabdominal suture fixation and (2) those undergoing hernia repairs consisting primarily of tack fixation', 'laparoscopic ventral hernia repair']","['postoperative pain', 'Postoperative pain', 'average age, BMI, hernia defect size, operative time, and postoperative length of stay', 'Pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia (procedure)'}, {'cui': 'C0181909', 'cui_str': 'Mount (physical object)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C3874006', 'cui_str': 'Tack'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C3874006', 'cui_str': 'Tack'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia (procedure)'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",50.0,0.152709,"Pain scores at 1 week, 1 month, and 2 months were similar.","[{'ForeName': 'Scott Q', 'Initials': 'SQ', 'LastName': 'Nguyen', 'Affiliation': 'Department of Surgery, Mount Sinai School of Medicine, New York, New York 10029, USA.'}, {'ForeName': 'Celia M', 'Initials': 'CM', 'LastName': 'Divino', 'Affiliation': ''}, {'ForeName': 'Kerri E', 'Initials': 'KE', 'LastName': 'Buch', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schnur', 'Affiliation': ''}, {'ForeName': 'Kaare J', 'Initials': 'KJ', 'LastName': 'Weber', 'Affiliation': ''}, {'ForeName': 'L Brian', 'Initials': 'LB', 'LastName': 'Katz', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Reiner', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Aldoroty', 'Affiliation': ''}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Herron', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2332,18435883,Umbilical port-site complications in laparoscopic cholecystectomy: role of topical antibiotic therapy.,"BACKGROUND AND OBJECTIVES
Umbilical port-site infections after video-laparoscopic cholecystectomy (VLC) are frequent complications. The aim of this prospective randomized study was to verify the validity of topical rifamycin for prevention of post-VLC umbilical infections.
METHODS
From September 2006 to April 2007, 48 patients with uncomplicated cholelithiasis who underwent VLC were enrolled in the study. Enrolled patients were randomized into 2 groups. The first group of 24 patients was treated with topical rifamycin to the umbilicus. The second group of 24 patients was not treated with rifamycin.
RESULTS
Postoperative umbilical pain with a need for analgesics, presence of signs of inflammation of the umbilical wound, dehiscence of the umbilical skin sutures, and the presence of incisional umbilical hernia on the 60th postoperative day were statistically significantly better in the rifamycin group compared with the control group.
CONCLUSIONS
Topical administration of rifamycin to the umbilicus in the pre-, intra- and postoperative periods was a rapid, safe, and economic way to reduce infective complications after VLC.",2008,"RESULTS
Postoperative umbilical pain with a need for analgesics, presence of signs of inflammation of the umbilical wound, dehiscence of the umbilical skin sutures, and the presence of incisional umbilical hernia on the 60th postoperative day were statistically significantly better in the rifamycin group compared with the control group.
","['laparoscopic cholecystectomy', '48 patients with uncomplicated cholelithiasis who underwent VLC were enrolled in the study', 'From September 2006 to April 2007']","['rifamycin', 'topical antibiotic therapy', 'video-laparoscopic cholecystectomy (VLC', 'topical rifamycin']","['presence of incisional umbilical hernia', 'Postoperative umbilical pain with a need for analgesics, presence of signs of inflammation of the umbilical wound, dehiscence of the umbilical skin sutures']","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008350', 'cui_str': 'Cholelithiasis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0035609', 'cui_str': 'Rifamycins'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1306503', 'cui_str': 'Exomphalos'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0232504', 'cui_str': 'Umbilical pain (finding)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]",48.0,0.0263303,"RESULTS
Postoperative umbilical pain with a need for analgesics, presence of signs of inflammation of the umbilical wound, dehiscence of the umbilical skin sutures, and the presence of incisional umbilical hernia on the 60th postoperative day were statistically significantly better in the rifamycin group compared with the control group.
","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Neri', 'Affiliation': 'University of Foggia, Department of Surgical Sciences, Division of General Surgery, Polyclinic Ospedali Riuniti, Foggia, Italy. tizpv@tiscali.it'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Fersini', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ambrosi', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Tartaglia', 'Affiliation': ''}, {'ForeName': 'Tiziano Pio', 'Initials': 'TP', 'LastName': 'Valentino', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2333,32432550,A Brief Music App to Address Pain in the Emergency Department: Prospective Study.,"BACKGROUND
Emergency physicians face the challenge of relieving acute pain daily. While opioids are a potent treatment for pain, the opioid epidemic has ignited a search for nonopioid analgesic alternatives that may decrease the dose or duration of opioid exposure. While behavioral therapies and complementary medicine are effective, they are difficult to deploy in the emergency department. Music is a potential adjunctive therapy that has demonstrated effectiveness in managing pain.
OBJECTIVE
Our objective was to understand the feasibility and potential for an effect of a novel music app to address acute pain and anxiety in patients admitted to an emergency department observation unit.
METHODS
This prospective cohort study enrolled patients admitted to an emergency department observation unit with pain who had received orders for opioids. We gathered baseline pain and psychosocial characteristics including anxiety, sleep disturbance, and pain catastrophizing using validated questionnaires. Participants received a smartphone-based music intervention and listened to the music in either a supervised (research assistant-delivered music session 3 times during their stay) or unsupervised manner (music used ad lib by participant). The app collected premusic and postmusic pain and anxiety scores, and participants provided qualitative feedback regarding acceptability of operating the music intervention.
RESULTS
We enrolled 81 participants and randomly assigned 38 to an unsupervised and 43 to a supervised group. Mean pain in both groups was 6.1 (1.8) out of a possible score of 10. A total of 43 (53%) reported previous use of music apps at home. We observed an overall modest but significant decrease in pain (mean difference -0.81, 95% CI -0.45 to -1.16) and anxiety (mean difference -0.72, 95% CI -0.33 to -1.12) after music sessions. Reduction of pain and anxiety varied substantially among participants. Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief. Changes in pain were correlated to changes in anxiety (Pearson ρ=0.3, P=.02) but did not vary between supervised and unsupervised groups. Upon conclusion of the study, 46/62 (74%) reported they liked the music intervention, 57/62 (92%) reported the app was easy to use, and 49/62 (79%) reported they would be willing to use the music intervention at home.
CONCLUSIONS
A smartphone-based music intervention decreased pain and anxiety among patients in an emergency department observation unit, with no difference between supervised and unsupervised use. Individuals reporting the greatest reduction in pain after music sessions included those scoring highest on baseline assessment of catastrophic thinking, suggesting there may be specific patient populations that may benefit more from using music as an analgesic adjunct in the emergency department. Qualitative feedback suggested that this intervention was feasible and acceptable by emergency department patients.",2020,"Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief.","['Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief', 'enrolled patients admitted to an emergency department observation unit with pain who had received orders for opioids', 'patients admitted to an emergency department observation unit']","['smartphone-based music intervention and listened to the music in either a supervised (research assistant-delivered music session 3 times during their stay) or unsupervised manner (music used ad lib by participant', 'smartphone-based music intervention', 'Music App', 'novel music app']","['Changes in pain', 'pain and anxiety', 'anxiety', 'Mean pain', 'pain', 'baseline pain and psychosocial characteristics including anxiety, sleep disturbance, and pain catastrophizing', 'acute pain and anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4284828', 'cui_str': 'Observation Units'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",81.0,0.0985102,"Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief.","[{'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Chai', 'Affiliation': ""Division of Medical Toxicology, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Schwartz', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Mohammad Adrian', 'Initials': 'MA', 'LastName': 'Hasdianda', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Desiree R', 'Initials': 'DR', 'LastName': 'Azizoddin', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, MA, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kikut', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Guruprasad D', 'Initials': 'GD', 'LastName': 'Jambaulikar', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Boyer', 'Affiliation': ""Division of Medical Toxicology, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Schreiber', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}]",Journal of medical Internet research,['10.2196/18537']
2334,31524140,The effect of a 4-week core strengthening program on determinants of wrestling performance in junior Greco-Roman wrestlers: A randomized controlled trial.,"BACKGROUND
Core-strength is vital for Greco-Roman wrestling, although studies have yet to establish the effectives of core-specific training in this sport.
OBJECTIVE
To examine the effect of core-specific strength training on determinants of Greco-Roman wrestling performance in elite junior athletes.
METHODS
Twenty state-level, junior, Greco-Roman wrestlers were randomized into a core-specific training group (COR; n= 12) and a control group (CON; n= 8). The COR group undertook a 4-week, core-specific training program concurrently with their typical training program, whilst the CON group completed 4 weeks of typical training only. Both groups completed overhead medicine ball throw (OMBT), Suplexes, bridges and medicine ball chest throw (MBCT) prior to and following the intervention.
RESULTS
The COR group demonstrated significantly greater improvement in bridges (p= 0.037; F= 5.046) and OMBT (p< 0.001; F= 26.43) than the CON group, with moderate to large between-group effect sizes (ES = 0.79-2.35). In addition, the effect size calculations were moderate-to-large (0.79-0.87) for Suplex and MBCT, with measures for the COR group greater than the CON group.
CONCLUSION
Accordingly, core-specific training programs should be combined with wrestling-specific conditioning programs to improve back and hip extensor performance in junior Greco-Roman wrestlers.",2020,"The COR group demonstrated significantly greater improvement in bridges (p= 0.037; F= 5.046) and OMBT (p< 0.001; F= 26.43) than the CON group, with moderate to large between-group effect sizes (ES = 0.79-2.35).","['Twenty state-level, junior', 'junior Greco-Roman wrestlers', 'elite junior athletes']","['core-specific strength training', '4-week core strengthening program', 'overhead medicine ball throw (OMBT), Suplexes, bridges and medicine ball chest throw (MBCT', 'core-specific training program concurrently with their typical training program, whilst the CON group completed 4 weeks of typical training only', 'CON']","['bridges', 'OMBT']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1720467', 'cui_str': 'Only'}]","[{'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}]",20.0,0.0227928,"The COR group demonstrated significantly greater improvement in bridges (p= 0.037; F= 5.046) and OMBT (p< 0.001; F= 26.43) than the CON group, with moderate to large between-group effect sizes (ES = 0.79-2.35).","[{'ForeName': 'Vahid Valipour', 'Initials': 'VV', 'LastName': 'Dehnou', 'Affiliation': 'Sport Sciences Department, Faculty of Literature and Human Sciences, Lorestan University, Lorestan Province, Iran.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Azadi', 'Affiliation': 'Sport Sciences Department, Faculty of Literature and Human Sciences, Lorestan University, Lorestan Province, Iran.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'Sport and Exercise Science, College of Healthcare Sciences, James Cook University, Townsville, Australia.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181328']
2335,31521543,A pragmatic randomized controlled trial exploring the relationship between pulse number and response to repetitive transcranial magnetic stimulation treatment in depression.,"BACKGROUND
Repetitive transcranial magnetic stimulation treatment (rTMS) is an effective treatment for depression but the optimal methods of administration have yet to be determined. In particular, it is unclear whether there is a relationship between elements of the dose of stimulation (i.e., number of pulses) and clinical response. To address one aspect of dose, we conducted a trial comparing standard and high dose versions of high frequency left sided and low frequency right sided rTMS protocols (left standard = 50 trains, left high = 125 trains, right standard = 20 min, right high = 60 min, all per day in a single session).
METHOD
300 patients with treatment resistant depression were enrolled in a four arm randomized controlled trial across a four week time period. The primary outcome assessment was a comparison of response and remission rates on data from the 17-item Hamilton Rating Scale for Depression Rating Scale (HRSD-17).
RESULTS
The rate of response exceeded 45% in all groups. There was no significant difference between groups on initial analysis of the primary or secondary outcome measures (response rates: standard left = 52.5%, high left = 47.3%, standard right = 49.1%, high right = 48.4%). There was a greater remission rate with high compared to moderate dose left sided treatment when controlling for illness duration. We also found significant improvements in quality of life across all treatment groups. Illness duration was weakly associated with response.
CONCLUSIONS
There was no consistent association between the antidepressant effect of rTMS and the number of TMS pulses provided across the ranges investigated in this study. Increasing TMS pulse number in individual sessions seems unlikely to be a method to substantially improve clinical outcomes, and future research should explore alternative means of improving clinical response. The study was registered on the Australian and New Zealand Clinical Trials Register (ACTRN12612000321842) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362063&isReview=true.",2020,"There was no significant difference between groups on initial analysis of the primary or secondary outcome measures (response rates: standard left = 52.5%, high left = 47.3%, standard right = 49.1%, high right = 48.4%).",['300 patients with treatment resistant depression'],"['Repetitive transcranial magnetic stimulation treatment (rTMS', 'rTMS', 'standard and high dose versions of high frequency left sided and low frequency right sided rTMS protocols (left standard\u202f=\u202f50 trains, left high\u202f=\u202f125 trains, right standard\u202f=\u202f20\u202fmin, right high\u202f=\u202f60\u202fmin, all per day in a single session', 'repetitive transcranial magnetic stimulation treatment']","['comparison of response and remission rates on data from the 17-item Hamilton Rating Scale for Depression Rating Scale (HRSD-17', 'Illness duration', 'quality of life', 'remission rate', 'rate of response']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0443246', 'cui_str': 'Left sided (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034380'}]",300.0,0.11053,"There was no significant difference between groups on initial analysis of the primary or secondary outcome measures (response rates: standard left = 52.5%, high left = 47.3%, standard right = 49.1%, high right = 48.4%).","[{'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, Victoria, Australia, 3004; Monash Alfred Psychiatry Research Centre, Monash University Central Clinical School, Commercial Rd, Melbourne, Victoria, Australia. Electronic address: paul.fitzgerald@monash.edu.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University Central Clinical School, Commercial Rd, Melbourne, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Biostatistics Consulting Platform, Faculty of Medicine, Nursing and Health Sciences, Monash University, Commercial Rd, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ajeet', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'The Geelong Clinic & Deakin University School of Medicine, Australia.'}, {'ForeName': 'Ranil', 'Initials': 'R', 'LastName': 'Gunewardene', 'Affiliation': 'Mosman Private Hospital, Mosman, New South Wales, 2088, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Slack', 'Affiliation': 'Pine Rivers Private Hospital, Strathpine, Queensland, 4500, Australia.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Northpark Private Hospital, Bundoora, Victoria, 3083, Australia.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Clarke Division, Toronto, Ontario, Canada.'}]",Brain stimulation,['10.1016/j.brs.2019.09.001']
2336,31521532,"Effectiveness of home-based and remotely supervised aerobic exercise in Parkinson's disease: a double-blind, randomised controlled trial.","BACKGROUND
High-intensity aerobic exercise might attenuate the symptoms of Parkinson's disease, but high-quality evidence is scarce. Moreover, long-term adherence remains challenging. We aimed to evaluate the effectiveness of aerobic exercise-gamified and delivered at home, to promote adherence-on relieving motor symptoms in patients with Parkinson's disease with mild disease severity who were on common treatment regimes.
METHODS
In this single-centre, double-blind, randomised controlled trial (Park-in-Shape), we recruited sedentary patients with Parkinson's disease from the outpatient clinic at Radboudumc, Nijmegen, Netherlands. Patients were made aware of the study either by their treating neurologist or via information in the waiting room. Patients could also contact the study team via social media. We included patients aged 30-75 years with a Hoehn and Yahr stage of 2 or lower, who were on stable dopaminergic medication. Patients were randomly assigned (in a 1:1 ratio) to either aerobic exercise done on a stationary home-trainer (aerobic intervention group) or stretching (active control group) by means of a web-based system with minimisation for sex and medication status (treated or untreated) and permuted blocks of varying sizes of more than two (unknown to study personnel). Patients were only aware of the content of their assigned programme. Assessors were unaware of group assignments. Both interventions were home based, requiring 30-45 min training three times per week for 6 months. Both groups received a motivational app and remote supervision. Home trainers were enhanced with virtual reality software and real-life videos providing a so-called exergaming experience (ie, exercise enhanced by gamified elements). The primary outcome was the between-group difference in the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor section at 6 months, tested during the off state (≥12 h after last dopaminergic medication). The analysis was done on an intention-to-treat basis in patients who completed the follow-up assessment, regardless of whether they completed the assigned intervention. Patients reported adverse events directly to their coach and also after the 6-month visit retrospectively. A between-group difference of 3·5 points or more was deemed a-priori clinically relevant. The study is concluded and registered with the Dutch Trial Registry, NTR4743.
FINDINGS
Between Feb 2, 2015, and Oct 27, 2017, 139 patients were assessed for eligibility in person, of whom 130 were randomly assigned to either the aerobic intervention group (n=65) or the active control group (n=65). Data from 125 (96%) patients were available for the primary analysis; five patients were lost to follow-up (four in the intervention group; one in the control group). 20 patients (ten in each group) did not complete their assigned programme. The off-state MDS-UPDRS motor score revealed a between-group difference of 4·2 points (95% CI 1·6-6·9, p=0·0020) in favour of aerobic exercise (mean 1·3 points [SE 1·8] in the intervention group and 5·6 points [SE 1·9] for the control group). 11 patients had potentially related adverse events (seven [11%] in the intervention group, four [6%] in the control group) and seven had unrelated serious adverse events (three in the intervention group [vestibilar disorder, vasovagal collapse, knee injury during gardening that required surgery; 6%], four in the control group [supraventricular tachycardia, hip fracture, fall related injury, severe dyskinesias after suprathreshold dose levodopa in a patient with deep brain stimulation; 7%]).
INTERPRETATION
Aerobic exercise can be done at home by patients with Parkinson's disease with mild disease severity and it attenuates off-state motor signs. Future studies should establish long-term effectiveness and possible disease-modifying effects.
FUNDING
Netherlands Organization for Health Research and Development.",2019,"The off-state MDS-UPDRS motor score revealed a between-group difference of 4·2 points (95% CI 1·6-6·9, p=0·0020) in favour of aerobic exercise (mean 1·3 points [SE 1·8] in the intervention group and 5·6 points [SE 1·9] for the control group).","['patients aged 30-75 years with a Hoehn and Yahr stage of 2 or lower, who were on stable dopaminergic medication', 'Patients were made aware of the study either by their treating neurologist or via information in the waiting room', ""patients with Parkinson's disease with mild disease severity who were on common treatment regimes"", ""Parkinson's disease"", ""sedentary patients with Parkinson's disease from the outpatient clinic at Radboudumc, Nijmegen, Netherlands"", ""patients with Parkinson's disease with mild disease severity and it attenuates off-state motor signs"", 'Between Feb 2, 2015, and Oct 27, 2017, 139 patients were assessed for eligibility in person, of whom 130', '20 patients (ten in each group) did not complete their assigned programme']","['aerobic exercise-gamified and delivered at home', 'levodopa', 'motivational app and remote supervision', 'aerobic exercise done on a stationary home-trainer (aerobic intervention group) or stretching (active control group) by means of a web-based system with minimisation for sex and medication status (treated or untreated) and permuted blocks of varying sizes of more than two (unknown to study personnel', 'virtual reality software and real-life videos providing a so-called exergaming experience (ie, exercise enhanced by gamified elements', 'active control group', 'Aerobic exercise', 'home-based and remotely supervised aerobic exercise', 'aerobic intervention']","['adverse events', ""Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor section"", 'supraventricular tachycardia, hip fracture, fall related injury, severe dyskinesias', 'vasovagal collapse, knee injury', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237426', 'cui_str': 'Neurologists'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1518543', 'cui_str': 'Off (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013879', 'cui_str': 'Elements'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}]",139.0,0.268757,"The off-state MDS-UPDRS motor score revealed a between-group difference of 4·2 points (95% CI 1·6-6·9, p=0·0020) in favour of aerobic exercise (mean 1·3 points [SE 1·8] in the intervention group and 5·6 points [SE 1·9] for the control group).","[{'ForeName': 'Nicolien M', 'Initials': 'NM', 'LastName': 'van der Kolk', 'Affiliation': 'Donders Institute for Brain, Cognition, and Behavior and Department of Neurology, Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Donders Institute for Brain, Cognition, and Behavior and Department of Neurology, Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Roy P C', 'Initials': 'RPC', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Psychology & Radboudumc Alzheimer Center, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Joosten', 'Affiliation': 'Canisius Wilhelmina Hospital, Department of Sports Medicine, Nijmegen, Netherlands.'}, {'ForeName': 'Aeilko H', 'Initials': 'AH', 'LastName': 'Zwinderman', 'Affiliation': 'Amsterdam University Medical Centers, Clinical Epidemiology & Biostatistics, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Post', 'Affiliation': 'Donders Institute for Brain, Cognition, and Behavior and Department of Neurology, Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Donders Institute for Brain, Cognition, and Behavior and Department of Neurology, Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center, Nijmegen, Netherlands. Electronic address: bas.bloem@radboudumc.nl.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30285-6']
2337,31860101,"An Educational Intervention for Improving Infant Sleep Duration-Why Won't You Sleep, Baby?",,2019,,[],['Educational Intervention'],[],[],[],[],,0.0334539,,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Health Services Research Group, Murdoch Children's Research Institute, Parkville, Australia.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.18061']
2338,31977628,"Norepinephrine for the prevention of spinal-induced hypotension during caesarean delivery under combined spinal-epidural anaesthesia: Randomised, double-blind, dose-finding study.","BACKGROUND
During caesarean delivery under spinal anaesthesia hypotension may be managed by norepinephrine in preference to phenylephrine due a perception of less bradycardia and fewer reductions in cardiac output.
OBJECTIVE
As the optimum prophylactic dose of norepinephrine is unclear, we aimed to investigate its dose-response for preventing postspinal hypotension in caesarean delivery.
DESIGN
A randomised, double-blinded, dose-finding study.
SETTING
Jiaxing University affiliated Women and Children Hospital, Jiaxing, China.
PATIENTS
Ninety-nine patients undergoing elective caesarean delivery from 1 February to 5 August: excluding patients with ASA III or above, preeclampsia or hypertension, pre-existing or gestational diabetes, BMI more than 35 kg m, height less than 150 cm or with more than 175 cm, or with contraindications to local anaesthesia.
INTERVENTIONS
Patients received 0, 0.04, 0.05, 0.06 or 0.07 μg kg min preventive norepinephrine infusions immediately after intrathecal injection of 10 mg bupivacaine with 5 μg sufentanil.
MAIN OUTCOME MEASURES
The norepinephrine (Median effective dose) or (95% effective dose) ED50 and ED95, which were estimated using Probit analysis to compare haemodynamic changes associated with the different doses.
RESULTS
The incidence of hypotension was 70, 47.4, 40, 20 and 15% in the 0, 0.04, 0.05, 0.06 and 0.07 μg kg min groups, respectively. The ED50, ED80 and ED95 values were 0.029 (95% CI 0.008 to 0.042 μg kg min), 0.068 (95% CI 0.055 to 0.099 μg kg min) and 0.105 μg kg min (95% CI 0.082 to 0.172 μg kg min), respectively. Apgar scores or umbilical arterial pH were similar among groups.
CONCLUSION
The ED50, ED80 and ED95 were 0.029, 0.068 and 0.105 μg kg min respectively. A 0.07 μg kg min norepinephrine infusion may be optimum for preventing postspinal hypotension after intrathecal injection of 10 mg bupivacaine combined with 5 μg sufentanil.
TRIAL REGISTRATION
Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-1800014614).",2020,"The ED50, ED80 and ED95 values were 0.029","['Ninety-nine patients undergoing elective caesarean delivery from 1 February to 5 August: excluding patients with ASA III or above, preeclampsia or hypertension, pre-existing or gestational diabetes, BMI more than 35\u200akg\u200am, height less than 150\u200acm or with more than 175\u200acm, or with contraindications to local anaesthesia', 'spinal-induced hypotension during caesarean delivery under combined spinal-epidural anaesthesia', 'Jiaxing University affiliated Women and Children Hospital, Jiaxing, China']","['norepinephrine', 'phenylephrine', 'bupivacaine', 'bupivacaine with 5\u200aμg sufentanil']","['postspinal hypotension', 'ED50, ED80 and ED95 values', 'Apgar scores or umbilical arterial pH', 'incidence of hypotension']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",99.0,0.637192,"The ED50, ED80 and ED95 values were 0.029","[{'ForeName': 'Changna', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ''}, {'ForeName': 'Yinfa', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Xiangyan', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Huijing', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001152']
2339,32050864,Randomized trial to assess safety/feasibility of memantine administration during residential treatment for alcohol use disorder: a pilot study.,"The N -methyl- D -aspartate receptor (NMDAr) system is critically involved in the pathogenesis and neurobehavioral sequelae of alcohol use disorder (AUD), and constitutes a potential pharmacotherapeutic target. Memantine (Namenda) is an FDA-approved NMDAr antagonist with suggested utility in AUD, however its safety and tolerability during long-term administration among recently-detoxified patients remains uncharacterized. This pilot study assessed safety, feasibility, and several secondary measures of interest, during a 4-week period of residential AUD treatment. Participants ( N = 18) met diagnostic criteria for AUD. A double-blind, placebo-controlled, escalating-dose design was utilized. Assessments of medication side-effects were conducted weekly. At intake, week 2, and study completion, participants completed a battery assessing affective symptomatology, craving, and neurocognitive function. Medication groups reported equivalent side effects and severity. Medication compliance was high, and did not differ by group. No memantine effects were observed in secondary outcome measures. Memantine maintains a profile of high tolerability and low side-effects during post-detoxification AUD treatment. These data suggest a more aggressive dosing/escalation schedule may be used safely in future trials designed to ascertain improvements in neurocognitive function, affect, and/or craving as primary measures.",2020,Medication groups reported equivalent side effects and severity.,"['alcohol use disorder', 'Participants ( N \u2009=\u200918) met diagnostic criteria for AUD']","['placebo', 'memantine', 'Memantine', 'Memantine (Namenda']","['safety and tolerability', 'equivalent side effects and severity', 'Medication compliance', 'battery assessing affective symptomatology, craving, and neurocognitive function']","[{'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C1330412', 'cui_str': 'Namenda'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3489773', 'cui_str': 'Medication Non-Compliance'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0868684,Medication groups reported equivalent side effects and severity.,"[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Merlo', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greene', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}]",Journal of addictive diseases,['10.1080/10550887.2020.1721404']
2340,32427638,The 11th Trial of a Cardiovascular Clinical Trialist: Coronavirus-2: Part 1.,,2020,,[],[],[],[],[],[],,0.0179934,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'From the Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, New York, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000316']
2341,32432556,Efficacy of Text Messaging and Personal Consultation by Pharmacy Students Among Adults With Hypertension: Randomized Controlled Trial.,"BACKGROUND
Hypertension is one of the leading risk factors for ischemic heart diseases, and high rates of hypertension prevalence have either remained the same or increased in developing countries in recent years. Unfortunately, about 20% to 50% of patients with chronic diseases have been nonadherent to their drug therapy. SMS text messaging and pharmacy student-led consultations have the potential to help patients manage their blood pressure (BP).
OBJECTIVE
The aim of this study was to assess the effectiveness, feasibility, and acceptability of SMS text messaging and consultation to manage the BP of Chinese patients with hypertension.
METHODS
We conducted a two-arm cluster randomized controlled trial among patients with hypertension in Xi'an City, Shaanxi Province, China, and recruited 384 patients from 8 community health care centers. Patients were randomized into an intervention group to receive SMS text messages and consultations or into a control group to receive usual care for 3 months. We sent SMS text messages at 3-day intervals and collected data at baseline (including demographics, clinical outcomes, medication complexity, side effects, patient behavior, knowledge about hypertension, BP, and medication adherence) and the 3-month follow-up (including BP, medication adherence, and knowledge about hypertension).
RESULTS
We assessed 445 patients with hypertension and excluded 61 patients who were not eligible or who had not filled out their questionnaires. The mean age of the patients was 68.5 (SD 7.9) years in the intervention group and 69.4 (SD 9.7) years in the control group, and the sample was primarily female (265/384, 69.0%). Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm Hg vs mean 140.7 mm Hg, SD 15.2 mm Hg; P=.001), medication adherence (mean 7.4, SD 1.2 vs mean 7.0, SD 1.3; P=.04), and knowledge about hypertension (mean 6.3, SD 0.9 vs mean 5.9, SD 1.2; P=.004) compared with those in the control group. In measures of diastolic BP (DBP), the two arms showed nonsignificant improvements (mean 78.2 mm Hg, SD 9.0 mm Hg vs mean 77.2 mm Hg, SD 10.3 mm Hg; P=.06). In total, 176 patients had controlled BP at the 3-month follow-up (98 patients in the intervention group vs 78 patients in the control group), but it was nonsignificant (P=.08).
CONCLUSIONS
The use of SMS text messaging and consultation to manage SBP and improve medication adherence is effective, feasible, and acceptable among Chinese patients with hypertension, although a significant difference was not observed with regard to DBP. It is important to maximize the potential of SMS text messaging and consultation by increasing the feasibility and acceptance of mobile interventions and conduct a cost-effectiveness analysis on this method.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR1900026862; http://www.chictr.org.cn/showproj.aspx?proj=42717.",2020,"Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm","['Chinese patients with hypertension', 'mean age of the patients was 68.5 (SD 7.9) years in the intervention group and 69.4 (SD 9.7) years in the control group, and the sample was primarily female (265/384, 69.0', '445 patients with hypertension and excluded 61 patients who were not eligible or who had not filled out their questionnaires', 'Pharmacy Students', ""patients with hypertension in Xi'an City, Shaanxi Province, China, and recruited 384 patients from 8 community health care centers"", 'Adults With Hypertension']","['SMS text messaging and consultation', 'Text Messaging and Personal Consultation', 'SMS text messages and consultations or into a control group to receive usual care for 3 months']","['controlled BP', 'medication adherence', 'diastolic BP (DBP', 'medication complexity, side effects, patient behavior, knowledge about hypertension, BP, and medication adherence) and the 3-month follow-up (including BP, medication adherence, and knowledge about hypertension', 'knowledge about hypertension', 'blood pressure (BP', 'effectiveness, feasibility, and acceptability', 'systolic BP (SBP']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",445.0,0.126857,"Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm","[{'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Zhai', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Khezar', 'Initials': 'K', 'LastName': 'Hayat', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Ji', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Naveel', 'Initials': 'N', 'LastName': 'Atif', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Pengchao', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Du', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}]",Journal of medical Internet research,['10.2196/16019']
2342,31524141,Comparison of clinical outcomes of ultrasonography-guided and blind local injections in facet syndrome: A 6-week randomized controlled trial.,"BACKGROUND
Facet syndrome is defined as pain that arises from any structure of the facet joints, including the fibrous capsule, synovial membrane, hyaline cartilage, and bone.
OBJECTIVES
To compare the effectiveness of US-guided and blind injections on clinical outcome in facet syndrome.
MATERIALS AND METHODS
Forty-seven patients with the diagnosis of facet syndrome were included. Patients were consecutively randomized into one of the two groups. The patient's history, physical examination and routine laboratory parameters were obtained and diagnose was established based on physical findings. Two injections (mixture of 2 ml of 1% lidocaine hydrochloride and 20 mg of triamcinolone, to a single or maximum two sites depending on the clinical characteristics of the facet joint) were performed with 15 days apart, as blinded or US-guided manner. Clinical outcome assessments were carried out at 0, 2nd and 6th weeks, using Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and State-Trait Anxiety Inventory (STAI).
RESULTS
The patients' initial VAS and ODI were not significantly different. When the two groups were compared in the 6th week in terms of VAS scores, improvement was more pronounced in the US-guided injection group (US-guided group (n= 23) before 7.6 (2.2) cm, after 3.0 (1.7) cm, P= 0.0001 vs blind group (n= 24) before 7.2 (1.3) cm, after 5.2 (2.0) cm, P= 0.0001). The improvement in initial and 6th week ODI was statistically significant in the US-guided injection group (P= 0.006). Except STAI I for US-group, trait anxiety scale scores were significant in both groups.
CONCLUSION
The US-guided local injections offer better clinical outcome in the treatment of facet syndrome.",2020,The improvement in initial and 6th week ODI was statistically significant in the US-guided injection group (P= 0.006).,"['Forty-seven patients with the diagnosis of facet syndrome were included', 'facet syndrome']","['ultrasonography-guided and blind local injections', 'US-guided and blind injections', 'Two injections (mixture of 2\xa0ml of 1% lidocaine hydrochloride and 20\xa0mg of triamcinolone']","['Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and State-Trait Anxiety Inventory (STAI', 'initial VAS and ODI', 'VAS scores', 'trait anxiety scale scores']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine Hydrochloride'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",47.0,0.0356601,The improvement in initial and 6th week ODI was statistically significant in the US-guided injection group (P= 0.006).,"[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Karkucak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medical School, Division of Rheumatology, Karadeniz Technical University, Farabi Hospital, Trabzon, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Batmaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Medical School, Dicle University, Diyarbakır, Turkey.'}, {'ForeName': 'Servet', 'Initials': 'S', 'LastName': 'Kerimoglu', 'Affiliation': 'Department Orthopaedics and Traumatology, Medical School, Karadeniz Technical University, Trabzon, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Ayar', 'Affiliation': 'Department Physiology, Medical School, Karadeniz Techical University, Trabzon, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181447']
2343,18402744,Evaluation of efficacy of four laparoscopic needle drivers.,"INTRODUCTION
To evaluate the impact of needle driver design on laparoscopic suturing skills by experts and novices.
METHODS
Three experienced laparoscopic surgeons and 3 novice junior residents were asked to perform a fixed set of suturing tasks in a laparoscopic pelvic-trainer. The laparoscopic needle drivers compared were (1) the Ethicon driver (E 705R), (2) Karl Storz (KS) pistol grip (26173 KC), (3) KS finger grip (26167 SK), and (4) KS palm grip (26173 ML). Times were recorded for each operator to grasp and position a needle for suturing in a particular angle, as well as to throw a horizontal and a vertical stitch and tie a single square knot using 2-0 Vicryl suture with a taper CT-1 needle. Subsequently, participants were asked to complete a subjective questionnaire rating the drivers.
RESULTS
The average suturing time provided the most discriminatory power in comparing the needle drivers. For experienced operators, the KS pistol grip allowed faster suturing times than did the KS finger grip and the KS palm grip but not the Ethicon driver. For novice users, the Ethicon driver allowed faster suturing times than did the KS finger grip but not the KS pistol grip or the KS palm grip. In the subjective questionnaire, the KS pistol grip received the highest scores, and the KS finger grip received the lowest scores.
CONCLUSION
Novice laparoscopists performed best with the KS pistol grip as well as the Ethicon laparoscopic needle drivers while experienced laparoscopists performed best with the pistol grip KS needle driver.",2008,"For experienced operators, the KS pistol grip allowed faster suturing times than did the KS finger grip and the KS palm grip but not the Ethicon driver.",['Three experienced laparoscopic surgeons and 3 novice junior residents'],"['KS pistol grip', 'laparoscopic pelvic-trainer', 'laparoscopic needle drivers']","['average suturing time', 'subjective questionnaire rating the drivers', 'Ethicon driver (E 705R), (2) Karl Storz (KS) pistol grip (26173 KC), (3) KS finger grip (26167 SK), and (4) KS palm grip', 'KS palm grip']","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0336677', 'cui_str': 'Pistol'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0336677', 'cui_str': 'Pistol'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}]",,0.021908,"For experienced operators, the KS pistol grip allowed faster suturing times than did the KS finger grip and the KS palm grip but not the Ethicon driver.","[{'ForeName': 'Anup P', 'Initials': 'AP', 'LastName': 'Ramani', 'Affiliation': 'Department of Urological Surgery, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Braasch', 'Affiliation': ''}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Botnaru', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lavers', 'Affiliation': ''}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Herrera', 'Affiliation': ''}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Nardi Pedro', 'Affiliation': ''}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Monga', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2344,31925817,"First-in-human clinical trial to assess the safety, tolerability and pharmacokinetics of P218, a novel candidate for malaria chemoprotection.","AIMS
This first-in-human clinical trial of P218, a novel dihydrofolate reductase inhibitor antimalarial candidate, assessed safety, tolerability, pharmacokinetics and food effects in healthy subjects.
METHODS
The study consisted of two parts. Part A was a double-blind, randomized, placebo-controlled, parallel group, ascending dose study comprising seven fasted cohorts. Eight subjects/cohort were randomized (3:1) to receive either a single oral dose of P218 (10, 30, 100, 250, 500, 750 and 1000 mg) or placebo. Part B was an open-label, cross-over, fed/fasted cohort (eight subjects) that received a 250 mg single dose of P218 in two treatment periods.
RESULTS
P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects. Nine adverse events in five subjects, all of mild intensity, were judged drug related. No clinically relevant abnormalities in ECG, vital signs or laboratory tests changes were observed. P218 was rapidly absorbed, with C max achieved between 0.5 and 2 hours post dose. Plasma concentrations declined bi-exponentially with half-life values ranging from 3.1 to 6.7 hours (10 and 30 mg), increasing up to 8.9 to 19.6 hours (doses up to 1000 mg). Exposure values increased dose-proportionally between 100 and 1000 mg for P218 (parent) and three primary metabolites (P218 β-acyl glucuronide, P218-OH and P218-OH β-acyl glucuronide). Co-administration of P218 with food reduced C max by 35% and delayed absorption by 1 hour, with no significant impact on AUC.
CONCLUSION
P218 displayed favourable safety, tolerability and pharmacokinetics. In view of its short half-life, a long-acting formulation will be needed for malaria chemoprotection.",2020,"RESULTS
P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects.",['healthy subjects'],"['placebo', 'Co']","['Plasma concentrations', 'safety, tolerability, pharmacokinetics and food effect', 'delayed absorption', 'safety, tolerability and pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",8.0,0.0945555,"RESULTS
P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects.","[{'ForeName': 'M Farouk', 'Initials': 'MF', 'LastName': 'Chughlay', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rossignol', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Donini', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'El Gaaloul', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lorch', 'Affiliation': 'Richmond Pharmacology Ltd, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coates', 'Affiliation': 'Richmond Pharmacology Ltd, London, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Langdon', 'Affiliation': 'PTx Solutions, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hammond', 'Affiliation': 'Preclinical Safety Consulting Ltd, Loughborough, Leicestershire, UK.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Möhrle', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Chalon', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14219']
2345,32432553,Midwives' Attitudes Toward and Experience With a Tablet Intervention to Promote Safety Behaviors for Pregnant Women Reporting Intimate Partner Violence: Qualitative Study.,"BACKGROUND
Violence against women is considered a global health problem, and intimate partner violence (IPV) around the time of childbirth can have severe consequences for mother and child. Prenatal care is considered a window of opportunity to address IPV and ask women about exposure to violence since women are in regular contact with health care providers. Mobile health (mHealth) interventions might overcome the barriers to talking about IPV face-to-face.
OBJECTIVE
Our objective was to explore midwives' attitudes toward a tablet intervention consisting of information about IPV and safety behaviors as well as their experiences with recruiting pregnant women of different ethnic backgrounds in a randomized controlled trial (RCT).
METHODS
Individual interviews were conducted with 9 midwives who recruited participants for an RCT to test a video to promote safety behaviors delivered on a tablet during prenatal care. Analysis was guided by thematic analysis.
RESULTS
Midwives perceived the tablet intervention as an appropriate supplement during prenatal care to provide information about IPV and promote safety behaviors. They participated in the RCT primarily to obtain more knowledge regarding how to communicate about IPV. The intervention was perceived as an anonymous door-opener to talk about IPV and a good solution to ensure that every woman gets the same information. However, the content of the intervention had to be trustworthy and align with the information the midwives provide to women. Given the sensitivity of IPV, midwives outlined the importance of following the intervention with face-to-face communication. Midwives reported technical problems and a high demand on their time as the main challenges to recruiting women. They experienced challenges recruiting women of different ethnic backgrounds due to linguistic barriers and the women's skepticism about scientific research.
CONCLUSIONS
The tablet intervention might help midwives communicate about IPV. Although the video was considered as an anonymous door-opener to talk about IPV, midwives outlined the importance of following the intervention with face-to-face communication. The scarcity of midwives' time during consultations has to be considered when implementing the intervention. Further research is needed to overcome barriers that limit inclusion of women from different ethnic backgrounds.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03397277; https://clinicaltrials.gov/ct2/show/NCT03397277.",2020,"RESULTS
Midwives perceived the tablet intervention as an appropriate supplement during prenatal care to provide information about IPV and promote safety behaviors.","['Violence against women', 'Individual interviews were conducted with 9 midwives who recruited participants for an', 'Pregnant Women Reporting Intimate Partner Violence']","['Tablet Intervention', 'RCT to test a video to promote safety behaviors delivered on a tablet during prenatal care', 'Mobile health (mHealth) interventions']",[],"[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]",[],9.0,0.0527447,"RESULTS
Midwives perceived the tablet intervention as an appropriate supplement during prenatal care to provide information about IPV and promote safety behaviors.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Garnweidner-Holme', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Henriksen', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Eva Marie', 'Initials': 'EM', 'LastName': 'Flaathen', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Klette Bøhler', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Lukasse', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}]",JMIR mHealth and uHealth,['10.2196/16828']
2346,31731527,"Altilix ® Supplement Containing Chlorogenic Acid and Luteolin Improved Hepatic and Cardiometabolic Parameters in Subjects with Metabolic Syndrome: A 6 Month Randomized, Double-Blind, Placebo-Controlled Study.","The objective was to evaluate the effects of 6 months of supplementation with Altilix ® , containing chlorogenic acid and its derivatives, and luteolin and its derivatives, on cardiovascular risk and hepatic markers in subjects with metabolic syndrome (MetS). A randomized, double-blind, placebo-controlled study was performed in 100 subjects with MetS with a follow-up period of 6 months; 50 subjects were randomized to Altilix ® (26 men and 24 women, mean age 63 ± 8 years) and the other 50 to placebo (28 men and 22 women, mean age 63 ± 11 years). Anthropometric, cardiometabolic, and hepatic parameters were assessed at baseline and at the end of follow-up. Carotid intima-media thickness and endothelial function were assessed by doppler ultrasound and by flow-mediated dilation of the brachial artery, respectively. The presence and degree of non-alcoholic fatty liver disease (NAFLD) was assessed by the fatty liver index (FLI), and subjects were divided into three subgroups: (1) without NAFLD; (2) with borderline NAFLD; and (3) with NAFLD. After 6 months of Altilix ® supplementation, we found a significant improvement vs. placebo in most of the evaluated parameters, including body weight (-2.40% (95% CI -3.79, -1.01); p < 0.001), waist circumference (-2.76% (95% CI -4.55, -0.96); p = 0.003), HbA1c (-0.95% (95% CI -1.22, -0.67); p < 0.001), plasma lipids, FLI (-21.83% (95% CI -27.39, -16.27); p < 0.001), hepatic transaminases, flow-mediated dilation (10.56% (95% CI 5.00, 16.12); p < 0.001), and carotid intima-media thickness (-39.48% (95% CI -47.98, -30.97); p < 0.001). Further, the improvement in cardiometabolic variables was independent of the degree of hepatic steatosis. Altilix ® supplementation improved hepatic and cardio-metabolic parameters in MetS subjects. Altilix ® supplementation was a beneficial approach in the management of hepatic and cardiometabolic alterations in MetS subjects.",2019,"After 6 months of Altilix ® supplementation, we found a significant improvement vs. placebo in most of the evaluated parameters, including body weight (-2.40% (95% CI -3.79, -1.01); p < 0.001), waist circumference (-2.76% (95% CI -4.55, -0.96); p = 0.003), HbA1c (-0.95% (95% CI -1.22, -0.67); p < 0.001), plasma lipids, FLI (-21.83% (95% CI -27.39, -16.27); p < 0.001), hepatic transaminases, flow-mediated dilation (10.56% (95% CI 5.00, 16.12); p < 0.001), and carotid intima-media thickness (-39.48% (95% CI -47.98, -30.97); p < 0.001).","['MetS subjects', '28 men and 22 women, mean age 63 ± 11 years', 'subjects with metabolic syndrome (MetS', '26 men and 24 women, mean age 63 ± 8 years) and', 'Subjects with Metabolic Syndrome', '100 subjects with MetS with a follow-up period of 6 months; 50 subjects']","['Placebo', 'Chlorogenic Acid and Luteolin', 'placebo', 'Altilix ® supplementation', 'Altilix ®', 'NAFLD', 'supplementation with Altilix ® , containing chlorogenic acid and its derivatives, and luteolin and its derivatives']","['hepatic and cardio-metabolic parameters', 'Carotid intima-media thickness and endothelial function', 'Anthropometric, cardiometabolic, and hepatic parameters', 'Hepatic and Cardiometabolic Parameters', 'body weight', 'plasma lipids, FLI', 'hepatic transaminases, flow-mediated dilation', 'cardiometabolic variables', 'carotid intima-media thickness', 'waist circumference', 'presence and degree of non-alcoholic fatty liver disease (NAFLD']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008240', 'cui_str': 'Chlorogenic acid'}, {'cui': 'C0065264', 'cui_str': 'Luteolin'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]",100.0,0.426236,"After 6 months of Altilix ® supplementation, we found a significant improvement vs. placebo in most of the evaluated parameters, including body weight (-2.40% (95% CI -3.79, -1.01); p < 0.001), waist circumference (-2.76% (95% CI -4.55, -0.96); p = 0.003), HbA1c (-0.95% (95% CI -1.22, -0.67); p < 0.001), plasma lipids, FLI (-21.83% (95% CI -27.39, -16.27); p < 0.001), hepatic transaminases, flow-mediated dilation (10.56% (95% CI 5.00, 16.12); p < 0.001), and carotid intima-media thickness (-39.48% (95% CI -47.98, -30.97); p < 0.001).","[{'ForeName': 'Giuseppa', 'Initials': 'G', 'LastName': 'Castellino', 'Affiliation': 'Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Nikolic', 'Affiliation': 'Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Magán-Fernández', 'Affiliation': 'Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Giuseppe Antonio', 'Initials': 'GA', 'LastName': 'Malfa', 'Affiliation': 'Department of Drug Science, Biochemistry Section, University of Catania, 95125 Catania, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Chianetta', 'Affiliation': 'Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'Patti', 'Affiliation': 'Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Amato', 'Affiliation': 'Department of Biological, Chemical and Pharmaceutical Sciences and Technologies (STEBICEF), University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Montalto', 'Affiliation': 'Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Toth', 'Affiliation': 'Department of Medicine, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD 21205-2196, USA.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Hypertension, Medical University of Lodz, 90137 Lodz, Poland.'}, {'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Manfredi', 'Initials': 'M', 'LastName': 'Rizzo', 'Affiliation': 'Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), University of Palermo, 90100 Palermo, Italy.'}]",Nutrients,['10.3390/nu11112580']
2347,31872894,Does adoption of an evidence-based practice lead to job turnover? Results from a randomized trial.,"It is important to understand the impact of implementation of evidence-based practices (EBPs) on the workforce. EBP implementation can increase job demands, stress, and burnout, and may thereby exacerbate turnover. This study examined the effects of implementation of an EBP on turnover among staff at nine child welfare agencies. A total of 102 providers were randomized to either adopt an EBP, SafeCare © , or continue providing services as usual. Participants completed a baseline survey assessing demographics, attitudes toward EBPs, and organizational functioning, and provider turnover was recorded for up to 18 months following implementation. The overall turnover rate was 35%, but did not differ by EBP assignment (odds ratio [OR] = 1.27; 95% confidence interval [0.66, 2.45]). Variables associated with turnover included age (OR = 0.92), years since degree completion (OR = 0.94), prior exposure to EBP (OR = 3.91), believing that adopting an EBP was burdensome (OR = 0.52), and motivation for change (OR = 0.89). EBP assignment moderated two aspects of negative attitudes toward EBP (divergence and monitoring) to predict turnover; those attitudes were only positively related to turnover for individuals assigned to the EBP (OR = 1.46, 1.16). Implications of the findings for implementation are discussed.",2020,"The overall turnover rate was 35%, but did not differ by EBP assignment (odds ratio [OR] = 1.27; 95% confidence interval [0.66, 2.45]).",['A total of 102 providers'],"['EBP implementation', 'EBP, SafeCare © , or continue providing services as usual', 'EBP']","['overall turnover rate', 'baseline survey assessing demographics, attitudes toward EBPs, and organizational functioning, and provider turnover']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0301051,"The overall turnover rate was 35%, but did not differ by EBP assignment (odds ratio [OR] = 1.27; 95% confidence interval [0.66, 2.45]).","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Whitaker', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Weeks', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Self-Brown', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Rabab', 'Initials': 'R', 'LastName': 'Zahidi', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}]",Journal of community psychology,['10.1002/jcop.22305']
2348,31468656,Cognitive and motor effects of Kinect-based games training in people with and without Parkinson disease: A preliminary study.,"OBJECTIVE
Purpose of this study is to evaluate the effects of training with six commercial Xbox Kinect TM games on cognitive and motor aspects in Parkinson's disease (PD) patients and to compare the effects with a group of paired healthy subjects.
METHODS
This study was a quasi-experimental, controlled trial. Eight individuals with PD (mean age 68.9 ± 7.9) and eight older adults without PD, matched by age (mean age 67.6 ± 7.3) were enrolled in the study. Ten sessions of six Xbox 360 Kinect TM commercial games were performed for 5 weeks. Subjects were evaluated before and 7 and 30 days after intervention. They were assessed using Montreal Cognitive Assessment, Frontal Assessment Battery (FAB), Timed Up and Go test, Ten Meters Walking test, and Balance Berg Scale. The Freezing of Gait Questionnaire, the Movement Disorder Society Unified Parkinson Disease Rating Scale, and the Parkinson's disease Questionnaire were also applied to PD group.
RESULTS
Significant improvement was found for cognitive aspects measured by Montreal Cognitive Assessment and FAB in both groups but without retention on FAB in PD group. No significant improvements were found for motor aspects in none group.
CONCLUSION
Motor-cognitive training using Xbox Kinect TM games is a feasible resource to improve executive functions in PD patients and in older healthy people.",2020,"RESULTS
Significant improvement was found for cognitive aspects measured by Montreal Cognitive Assessment and FAB in both groups but without retention on FAB in PD group.","['Eight individuals with PD (mean age 68.9 ± 7.9) and eight older adults without PD, matched by age (mean age 67.6 ± 7.3) were enrolled in the study', ""Parkinson's disease (PD) patients"", 'PD patients and in older healthy people', 'paired healthy subjects', 'people with and without Parkinson disease']","['Kinect-based games training', 'training with six commercial Xbox Kinect TM games']","['Montreal Cognitive Assessment, Frontal Assessment Battery (FAB), Timed Up and Go test, Ten Meters Walking test, and Balance Berg Scale', 'executive functions', 'Freezing of Gait Questionnaire, the Movement Disorder Society Unified Parkinson Disease Rating Scale', 'Cognitive and motor effects', 'cognitive aspects measured by Montreal Cognitive Assessment and FAB']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C3496286'}, {'cui': 'C2732353', 'cui_str': 'Frontal assessment battery'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0222045'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0243151', 'cui_str': 'cognitive aspects'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",8.0,0.0102225,"RESULTS
Significant improvement was found for cognitive aspects measured by Montreal Cognitive Assessment and FAB in both groups but without retention on FAB in PD group.","[{'ForeName': 'Thília Maria', 'Initials': 'TM', 'LastName': 'de Melo Cerqueira', 'Affiliation': 'Faculty of Ceilàndia, Department of Physiotherapy, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Júlia Araújo', 'Initials': 'JA', 'LastName': 'de Moura', 'Affiliation': 'Faculty of Ceilândia, Post-graduation program in Rehabilitation Sciences, Univeristy of Brasília, Brasília, Brazil.'}, {'ForeName': 'Juliana Onofre', 'Initials': 'JO', 'LastName': 'de Lira', 'Affiliation': 'Faculty of Ceilândia, Department of Phonoaudiology, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Josevan Cerqueira', 'Initials': 'JC', 'LastName': 'Leal', 'Affiliation': 'Faculty of Ceilândia, Department of Phonoaudiology, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': ""D'Amelio"", 'Affiliation': 'Dipartimento di Biomedicina, Neuroscienze e Diagnostica Avanzata (BiND), Università degli Studi di Palermo, Italy.'}, {'ForeName': 'Felipe Augusto', 'Initials': 'FA', 'LastName': 'do Santos Mendes', 'Affiliation': 'Faculty of Ceilândia, Post-graduation program in Rehabilitation Sciences, Univeristy of Brasília, Brasília, Brazil.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1807']
2349,31744060,Daily Ingestion of Eggplant Powder Improves Blood Pressure and Psychological State in Stressed Individuals: A Randomized Placebo-Controlled Study.,"Eggplant ( Solanum melongena ) is a globally popular vegetable and its significant health effect has not been reported in randomized controlled trials. Recently, we reported that eggplant was rich in choline esters, including acetylcholine (ACh), and had an antihypertensive effect in spontaneously hypertensive rats. Here, we evaluated the effects of a continuous intake of eggplant powder on blood pressure (BP), stress, and psychological state (PS) in 100 stressed participants with normal-high BP or grade 1 hypertension in a randomized, double-blind, placebo-controlled, parallel-group comparative study. The participants were randomly assigned to the eggplant or placebo group. Participants in the eggplant group ingested capsules containing eggplant powder (1.2 g/day; 2.3 mg of ACh/day) for 12 weeks, whereas participants in the placebo group ingested placebo capsules. The primary outcome assessed was hospital BP. Secondary outcomes were stress and PS. Eggplant powder intake significantly decreased the hospital diastolic blood pressure (DBP) at week 8 overall and in the normal-high BP group, and the systolic blood pressure (SBP) and DBP at week 12 overall and in the grade 1 hypertension group, compared to those of the placebo group. It also improved negative PSs at week 8 or 12 in the normal-high BP group. This is the first evidence of the BP- and PS-improving effects of eggplant intake in humans. The functional substance responsible for the effects was estimated to be eggplant-derived choline ester, namely ACh.",2019,"Eggplant powder intake significantly decreased the hospital diastolic blood pressure (DBP) at week 8 overall and in the normal-high BP group, and the systolic blood pressure (SBP) and DBP at week 12 overall and in the grade 1 hypertension group, compared to those of the placebo group.","['spontaneously hypertensive rats', '100 stressed participants with normal-high BP or grade 1 hypertension', 'Stressed Individuals', 'humans']","['placebo capsules', 'Placebo', 'eggplant group ingested capsules containing eggplant powder', 'eggplant or placebo', 'Eggplant Powder', 'placebo', 'eggplant powder']","['Blood Pressure and Psychological State', 'hospital BP', 'stress and PS', 'blood pressure (BP), stress, and psychological state (PS', 'hospital diastolic blood pressure (DBP', 'negative PSs', 'systolic blood pressure (SBP) and DBP']","[{'cui': 'C0034705', 'cui_str': 'Rats, SHR'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0453111', 'cui_str': 'Aubergine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.554202,"Eggplant powder intake significantly decreased the hospital diastolic blood pressure (DBP) at week 8 overall and in the normal-high BP group, and the systolic blood pressure (SBP) and DBP at week 12 overall and in the grade 1 hypertension group, compared to those of the placebo group.","[{'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'Department of Medical Management and Informatics, Hokkaido Information University, Hokkaido 069-8585, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Agriculture, Graduate School of Science and Technology, Shinshu University, Nagano 399-4598, Japan.'}, {'ForeName': 'Ryuto', 'Initials': 'R', 'LastName': 'Takahashi', 'Affiliation': 'Department of Agriculture, Graduate School of Science and Technology, Shinshu University, Nagano 399-4598, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Science and Technology, Graduate School of Medicine, Science and Technology, Shinshu University, Nagano 399-4598, Japan.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Tsubaki', 'Affiliation': 'Future Business Search Team, Planning Department, R & D Division, ADEKA co., Tokyo 116-8554, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Agriculture, Graduate School of Science and Technology, Shinshu University, Nagano 399-4598, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nishihira', 'Affiliation': 'Department of Medical Management and Informatics, Hokkaido Information University, Hokkaido 069-8585, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Agriculture, Graduate School of Science and Technology, Shinshu University, Nagano 399-4598, Japan.'}]",Nutrients,['10.3390/nu11112797']
2350,17761080,Prospective randomized comparison of cutting and dilating disposable trocars for access during laparoscopic renal surgery.,"BACKGROUND AND OBJECTIVES
Traditional trocar tip design for laparoscopic access incorporates cutting blades to penetrate the body wall. More recently, trocars applying tissue dilation have been used that create a smaller defect, seldom requiring fascial wound closure. Four 12-mm commercially available single-use trocar designs were evaluated for postoperative pain.
METHODS
The 4-trocar types included 2 cutting (single or pyramidal bladed) and 2 dilating trocars (radially or axially dilating) type. Fifty-six patients undergoing transperitoneal laparoscopic renal surgery were randomized and blinded to one of the 4 trocar types. In each case, trocars were placed in a standard ""diamond"" configuration: three 12-mm study trocars and a lateral 5-mm trocar that served as a reference point for normalizing patients' pain scores. Postoperative pain based on a visual analog scale and complications were assessed.
RESULTS
No statistically significant difference existed in pain scores between different trocar types or trocar sites at 3-hour, 24-hour, and 1-week postoperative assessment time points. Eight (4.8%) minor complications occurred: bleeding in 7 (4.2%) and 1 (0.6%) wound infection. The radially dilating trocar had more device malfunction (P<0.05) than did the others.
CONCLUSION
All 4 disposable trocars, muscle cutting or dilating type, were safe and yielded similar postoperative pain scores with or without the fascial wound closure after renal laparoscopy.",2007,"All 4 disposable trocars, muscle cutting or dilating type, were safe and yielded similar postoperative pain scores with or without the fascial wound closure after renal laparoscopy.","['Fifty-six patients undergoing transperitoneal laparoscopic renal surgery', 'laparoscopic renal surgery']","['cutting and dilating disposable trocars', '2 cutting (single or pyramidal bladed) and 2 dilating trocars (radially or axially dilating) type']","['complications occurred: bleeding', 'Postoperative pain', 'postoperative pain scores', 'wound infection', 'pain scores', 'visual analog scale and complications', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach (qualifier value)'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation (procedure)'}]","[{'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C1272741', 'cui_str': 'Disposable trocar'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",56.0,0.105345,"All 4 disposable trocars, muscle cutting or dilating type, were safe and yielded similar postoperative pain scores with or without the fascial wound closure after renal laparoscopy.","[{'ForeName': 'Ramakrishna', 'Initials': 'R', 'LastName': 'Venkatesh', 'Affiliation': 'Washington University School of Medicine, Division of Urology, St. Louis, Missouri 63110, USA. venkateshr@wudosis.wustl.edu'}, {'ForeName': 'Chandru P', 'Initials': 'CP', 'LastName': 'Sundaram', 'Affiliation': ''}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Figenshau', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': ''}, {'ForeName': 'Ralph V', 'Initials': 'RV', 'LastName': 'Clayman', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Landman', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2351,32428747,A synergistic effect between family intervention and rTMS improves cognitive and negative symptoms in schizophrenia: A randomized controlled trial.,"OBJECTIVE
The present study explored an efficient new therapy that combined repetitive transcranial magnetic stimulation (rTMS) and family intervention in addition to risperidone to improve schizophrenia.
METHODS
A randomized controlled trial (January 2016-September 2017) involving 200 patients, of which 188 patients completed the 12-week study, and 50 controls were conducted in the research. The patients were randomly assigned to 12 weeks of treatment with risperidone alone (risperidone group), rTMS and risperidone (rTMS group), family intervention and risperidone (family intervention group), rTMS and risperidone plus family intervention (combined group). MATRICS Consensus Cognitive Battery (MCCB) and the Positive and Negative Symptoms Scale (PANSS) were used to evaluate treatment efficacy. Repeated measures analysis of variance (RMANOVA) were performed to evaluate different treatment efficacy between four groups after 12 weeks of treatment.
RESULTS
(1) There were no significant differences in sex, age, education, cognitive function, or PANSS scores between the four groups at baseline (p's > 0.05). (2) There was a significant decrease in the PANSS scores and an increase in the MCCB scores after 12 weeks of treatment in all groups (time effect p's < 0.001). (3) The improvements in positive symptoms and negative symptoms were more obvious in the combined group than in other groups (p's < 0.05). (4) The combined group showed the superior effect in cognition function after 12 weeks. (5) And, interestingly, a remarkable synergistic effect between rTMS and family intervention therapy was observed.
CONCLUSION
There was a synergistic effect between rTMS and the family intervention as an effective combined therapy in improving schizophrenia. This study is registered with Chictr.org, number ChiCTR1900024422 (http://www.chictr.org.cn/edit.aspx?pid=34285&htm=4).",2020,The improvements in positive symptoms and negative symptoms were more obvious in the combined group than in other groups (,"['schizophrenia', '200 patients, of which 188 patients completed the 12-week study, and 50 controls were conducted in the research']","['risperidone', 'combined repetitive transcranial magnetic stimulation (rTMS', 'risperidone alone (risperidone group), rTMS and risperidone (rTMS group), family intervention and risperidone (family intervention group), rTMS and risperidone plus family intervention (combined group', 'rTMS']","['sex, age, education, cognitive function, or PANSS scores', 'MCCB scores', 'positive symptoms and negative symptoms', 'PANSS scores', 'Consensus Cognitive Battery (MCCB) and the Positive and Negative Symptoms Scale (PANSS', 'cognitive and negative symptoms', 'cognition function']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",200.0,0.0287929,The improvements in positive symptoms and negative symptoms were more obvious in the combined group than in other groups (,"[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiuxia', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Biomedical Engineering, College of Engineering, Peking University, Beijing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Supervision Bureau of the Health and Family Planning Commission, Wancheng District, Nanyang City, China.'}, {'ForeName': 'Qiyue', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Luxian', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Henan Province Mental Hospital, The Second Affiliated Hospital, Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Xu-Feng', 'Initials': 'XF', 'LastName': 'Huang', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Medicine, University of Wollongong, NSW2522, Australia. Electronic address: xhuang@uow.edu.au.'}, {'ForeName': 'Xueqin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China. Electronic address: fccsongxq@zzu.edu.cn.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.009']
2352,30237584,Genome-wide association analysis of common genetic variants of resistant hypertension.,"Resistant hypertension (RHTN), defined as uncontrolled blood pressure (BP) ≥ 140/90 using three or more drugs or controlled BP (<140/90) using four or more drugs, is associated with adverse outcomes, including decline in kidney function. We conducted a genome-wide association analysis in 1194 White and Hispanic participants with hypertension and coronary artery disease from the INternational VErapamil-SR Trandolapril STudy-GENEtic Substudy (INVEST-GENES). Top variants associated with RHTN at p < 10 -4 were tested for replication in 585 White and Hispanic participants with hypertension and subcortical strokes from the Secondary Prevention of Subcortical Strokes GENEtic Substudy (SPS3-GENES). A genetic risk score for RHTN was created by summing the risk alleles of replicated RHTN signals. rs11749255 in MSX2 was associated with RHTN in INVEST (odds ratio (OR) (95% CI) = 1.50 (1.2-1.8), p = 7.3 × 10 -5 ) and replicated in SPS3 (OR = 2.0 (1.4-2.8), p = 4.3 × 10 -5 ), with genome-wide significance in meta-analysis (OR = 1.60 (1.3-1.9), p = 3.8 × 10 -8 ). Other replicated signals were in IFLTD1 and PTPRD. IFLTD1 rs6487504 was associated with RHTN in INVEST (OR = 1.90 (1.4-2.5), p = 1.1 × 10 - 5 ) and SPS3 (OR = 1.70 (1.2-2.5), p = 4 × 10 -3 ). PTPRD rs324498, a previously reported RHTN signal, was among the top signals in INVEST (OR = 1.60 (1.3-2.0), p = 3.4 × 10 - 5 ) and replicated in SPS3 (OR = 1.60 (1.1-2.4), one-sided p = 0.005). Participants with the highest number of risk alleles were at increased risk of RHTN compared to participants with a lower number (p-trend = 1.8 × 10 -15 ). Overall, we identified and replicated associations with RHTN in the MSX2, IFLTD1, and PTPRD regions, and combined these associations to create a genetic risk score.",2019,"IFLTD1 rs6487504 was associated with RHTN in INVEST (OR = 1.90 (1.4-2.5), p = 1.1 × 10 - 5 ) and SPS3 (OR = 1.70 (1.2-2.5), p = 4 × 10 -3 ).","['1194 White and Hispanic participants with hypertension and coronary artery disease from the INternational', '585 White and Hispanic participants with hypertension and subcortical strokes']",['VErapamil-SR Trandolapril'],[],"[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0076891', 'cui_str': 'trandolapril'}]",[],1194.0,0.0629486,"IFLTD1 rs6487504 was associated with RHTN in INVEST (OR = 1.90 (1.4-2.5), p = 1.1 × 10 - 5 ) and SPS3 (OR = 1.70 (1.2-2.5), p = 4 × 10 -3 ).","[{'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'El Rouby', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Caitrin W', 'Initials': 'CW', 'LastName': 'McDonough', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'McClure', 'Affiliation': 'Department of Epidemiology and Biostatistics, Dornsife School of Public Health, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Braxton D', 'Initials': 'BD', 'LastName': 'Mitchell', 'Affiliation': 'Division of Endocrinology, Diabetes and Nutrition, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Horenstein', 'Affiliation': 'Division of Endocrinology, Diabetes and Nutrition, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Talbert', 'Affiliation': 'College of Pharmacy, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Dana C', 'Initials': 'DC', 'LastName': 'Crawford', 'Affiliation': 'Epidemiology and Biostatistics, Institute for Computational Biology, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Gitzendanner', 'Affiliation': 'Department of Biology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'RIKEN Center for Integrative Medical Sciences, Yokohama, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'RIKEN Center for Integrative Medical Sciences, Yokohama, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Kubo', 'Affiliation': 'RIKEN Center for Integrative Medical Sciences, Yokohama, Japan.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Cooper-DeHoff', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Oscar R', 'Initials': 'OR', 'LastName': 'Benavente', 'Affiliation': 'Department of Neurology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Shuldiner', 'Affiliation': 'Division of Endocrinology, Diabetes and Nutrition, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, College of Pharmacy, University of Florida, Gainesville, FL, USA. johnson@cop.ufl.edu.'}]",The pharmacogenomics journal,['10.1038/s41397-018-0049-x']
2353,17931510,Criterion-based training with surgical simulators: proficiency of experienced surgeons.,"OBJECTIVE
In our effort to establish criterion-based skills training for surgeons, we assessed the performance of 17 experienced laparoscopic surgeons on basic technical surgical skills recorded electronically in 26 modules selected in 5 commercially available, computer-based simulators.
METHODS
Performance data were derived from selected surgeons randomly assigned to simulator stations, and practicing repetitively during one and one-half day sessions on 5 different simulators. We measured surgeon proficiency defined as efficient, error-free performance and developed proficiency score formulas for each module. Demographic and opinion data were also collected.
RESULTS
Surgeons' performance demonstrated a sharp learning curve with the most performance improvement seen in early practice attempts. Median scores and performance levels at the 10th, 25th, 75th, and 90th percentiles are provided for each module. Construct validity was examined for 2 modules by comparing experienced surgeons' performance with that of a convenience sample of less-experienced surgeons.
CONCLUSION
A simple mathematical method for scoring performance is applicable to these simulators. Proficiency levels for training courses can now be specified objectively by residency directors and by professional organizations for different levels of training or post-training assessment of technical performance. But data users should be cautious due to the small sample size in this study and the need for further study into the reliability and validity of the use of surgical simulators as assessment tools.",2007,"Construct validity was examined for 2 modules by comparing experienced surgeons' performance with that of a convenience sample of less-experienced surgeons.
","['Performance data were derived from selected surgeons randomly assigned to simulator stations, and practicing repetitively during one and one-half day sessions on 5 different simulators', '17 experienced laparoscopic surgeons on basic technical surgical skills recorded electronically in 26 modules selected in 5 commercially available, computer-based simulators']",[],['Median scores and performance levels'],"[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C1275574', 'cui_str': 'one half day'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",26.0,0.0641154,"Construct validity was examined for 2 modules by comparing experienced surgeons' performance with that of a convenience sample of less-experienced surgeons.
","[{'ForeName': 'Wm LeRoy', 'Initials': 'WL', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Obstetrics-Gynecology, Stanford University, 251 Campus Drive West, Stanford, CA 94305, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lukoff', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Youngblood', 'Affiliation': ''}, {'ForeName': 'Parvati', 'Initials': 'P', 'LastName': 'Dev', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Shavelson', 'Affiliation': ''}, {'ForeName': 'Harrith M', 'Initials': 'HM', 'LastName': 'Hasson', 'Affiliation': ''}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': ''}, {'ForeName': 'Elspeth M', 'Initials': 'EM', 'LastName': 'McDougall', 'Affiliation': ''}, {'ForeName': 'Paul Alan', 'Initials': 'PA', 'LastName': 'Wetter', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2354,17931519,Three-port versus standard four-port laparoscopic cholecystectomy: a randomized controlled clinical trial in a community-based teaching hospital in eastern Nepal.,"OBJECTIVES
With increasing surgeon experience, laparoscopic cholecystectomy has undergone many refinements including reduction in port number and size. Three-port laparoscopic cholecystectomy has been reported to be safe and feasible in various clinical trials. However, whether it offers any additional advantages remains controversial. This study reports a randomized trial that compared the clinical outcomes of 3-port laparoscopic cholecystectomy versus conventional 4-port laparoscopic cholecystectomy.
METHODS
Seventy-five consecutive patients who underwent elective laparoscopic cholecystectomy were randomized to undergo either the 3-port or the 4-port technique. Four surgical tapes were applied to standard 4-port sites in both groups at the end of the operation. All dressings were kept intact until the first follow-up 1 week after surgery. Postoperative pain at the 4 sites was assessed on the first day after surgery by using a 10-cm unscaled visual analog scale (VAS). Other outcome measures included analgesia requirements, length of the operation, postoperative stay, and patient satisfaction score on surgery and scars.
RESULTS
Demographic data were comparable for both groups. Patients in the 3-port group had shorter mean operative time (47.3+/-29.8 min vs 60.8+/-32.3 min) for the 4-port group (P=0.04) and less pain at port sites (mean score using 10-cm unscaled VAS: 2.19+/-1.06 vs 2.91+/-1.20 (P=0.02). Overall pain score, analgesia requirements, hospital stay, and patient satisfaction score (mean score using 10-cm unscaled VAS: 8.2+/-1.7 vs 7.8+/-1.7, P=0.24) on surgery and scars were similar between the 2 groups.
CONCLUSION
Three-port laparoscopic cholecystectomy resulted in less individual port-site pain and similar clinical outcomes with fewer surgical scars and without any increased risk of bile duct injury compared with 4-port laparoscopic cholecystectomy. Thus, it can be recommended as a safe alternative procedure in elective laparoscopic cholecystectomy.",2007,"CONCLUSION
Three-port laparoscopic cholecystectomy resulted in less individual port-site pain and similar clinical outcomes with fewer surgical scars and without any increased risk of bile duct injury compared with 4-port laparoscopic cholecystectomy.","['Seventy-five consecutive patients who underwent', 'community-based teaching hospital in eastern Nepal', 'elective laparoscopic cholecystectomy']","['laparoscopic cholecystectomy', '4-port laparoscopic cholecystectomy', 'elective laparoscopic cholecystectomy', '3-port laparoscopic cholecystectomy versus conventional 4-port laparoscopic cholecystectomy', 'Three-port versus standard four-port laparoscopic cholecystectomy']","['pain', 'shorter mean operative time', 'Postoperative pain', 'analgesia requirements, length of the operation, postoperative stay, and patient satisfaction score on surgery and scars', 'individual port-site pain', 'Overall pain score, analgesia requirements, hospital stay, and patient satisfaction score', 'risk of bile duct injury']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0434034', 'cui_str': 'Injury of bile duct (disorder)'}]",75.0,0.0271258,"CONCLUSION
Three-port laparoscopic cholecystectomy resulted in less individual port-site pain and similar clinical outcomes with fewer surgical scars and without any increased risk of bile duct injury compared with 4-port laparoscopic cholecystectomy.","[{'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgery, B P Koirala Institute of Health Sciences, Dharan, Nepal. docmk_2002@yahoo.co.in'}, {'ForeName': 'Chandra Shekhar', 'Initials': 'CS', 'LastName': 'Agrawal', 'Affiliation': ''}, {'ForeName': 'Rakesh Kumar', 'Initials': 'RK', 'LastName': 'Gupta', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2355,31356374,Comparison of neostigmine vs. sugammadex for recovery of muscle function after neuromuscular block by means of diaphragm ultrasonography in microlaryngeal surgery: A randomised controlled trial.,"BACKGROUND
Postoperative residual curarisation (PORC) is a risk directly related to the use of neuromuscular blocking agents during surgical procedures. Acceleromyography is distressing for conscious patients when assessing PORC. Diaphragm ultrasonography could be a valid alternative.
OBJECTIVES
The primary objective was to achieve a 28% lower incidence of PORC in patients who, after rocuronium administration, received neostigmine or sugammadex at 30 min after surgery. To assess PORC, diaphragm ultrasonography was used, and thickening fractioning [the difference of thickness at the end of inspiration (TEI) and at the end of expiration (TEE), normalised for TEE (TEI - TEE/TEE)] was measured. PORC was defined as thickening fractioning of 0.36 or less. The secondary object was the comparison, in the two treatment groups, of the return to baseline thickening fractioning at 30 min after surgery (ΔTF30).
DESIGN
Randomised, double-blind, single-centre study.
SETTING
University Hospital Careggi, Florence, Italy.
PATIENTS
Patients of American Society Anesthesiologists' physical status 1 or 2, 18 to 80 years, receiving rocuronium during microlaryngeal surgery.
INTERVENTIONS
At the end of surgery participants were randomised to receive neostigmine (NEO group) or sugammadex (SUG group) as the reversal drug. Thickening fractioning and ΔTF30 were evaluated at baseline and at 0, 10 and 30 min after surgery.
MAIN OUTCOME MEASURES
TEE and TEI at each time point.
RESULTS
A total of 59 patients with similar demographic characteristics were enrolled. An association between lack of recovery (thickening fractioning ≤0.36) and drug treatment was only observed at 0 min (SUG vs. NEO, P < 0.05). Concerning ΔTF, at 30 min more patients in the SUG group returned to baseline than those in the NEO group (P < 0.001), after adjusting for side (P = 0.52), baseline thickening fractioning (P < 0.0001) and time of measurement (P < 0.01).
CONCLUSION
We found an early (0 min) but not long-lasting (30 min) association between diaphragm failure and treatment allocation; a full recovery in baseline diaphragm function was observed only in patients receiving sugammadex. We cannot exclude that further differences have not been found due to interpatients variability in assessing diaphragm contractility by ultrasonography.
TRIAL REGISTRATION
EudraCT Identifier: 2013-004787-62, Clinicaltrials.gov Identifier: NCT02698969.",2020,"An association between lack of recovery (thickening fractioning ≤0.36) and drug treatment was only observed at 0 min (SUG vs. NEO, P < 0.05).","['microlaryngeal surgery', '59 patients with similar demographic characteristics were enrolled', ""Patients of American Society Anesthesiologists' physical status 1 or 2, 18 to 80 years, receiving rocuronium during microlaryngeal surgery"", 'University Hospital Careggi, Florence, Italy', 'patients receiving sugammadex']","['Diaphragm ultrasonography', 'neostigmine vs. sugammadex', 'Acceleromyography', 'curarisation (PORC', 'diaphragm ultrasonography', 'neostigmine (NEO group) or sugammadex (SUG group', 'neostigmine or sugammadex']","['muscle function', 'Thickening fractioning and ΔTF30', 'baseline thickening fractioning', 'PORC', 'thickness at the end of inspiration (TEI) and at the end of expiration (TEE), normalised for TEE (TEI\u200a-\u200aTEE/TEE', 'incidence of PORC', 'baseline diaphragm function']","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C3805242', 'cui_str': 'Acceleromyography'}, {'cui': 'C1112352', 'cui_str': 'Neuromuscular blocking therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0205400', 'cui_str': 'Thickened (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.408617,"An association between lack of recovery (thickening fractioning ≤0.36) and drug treatment was only observed at 0 min (SUG vs. NEO, P < 0.05).","[{'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Cappellini', 'Affiliation': 'From the Department of Health Sciences, Azienda Ospedaliero Universitaria Careggi (IC, DO, BL, ARDG, CA) and Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Florence, Italy (LT).'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Ostento', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Loriga', 'Affiliation': ''}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Tofani', 'Affiliation': ''}, {'ForeName': 'Angelo R', 'Initials': 'AR', 'LastName': 'De Gaudio', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Adembri', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001055']
2356,31180819,Prospective Multicenter Study on the Prognostic and Predictive Impact of Tumor Budding in Stage II Colon Cancer: Results From the SACURA Trial.,"PURPOSE
The International Union Against Cancer highlighted tumor budding as a tumor-related prognostic factor. International assessment criteria for tumor budding were recently defined by the 2016 International Tumor Budding Consensus Conference (ITBCC2016). This study aimed to clarify the prognostic and predictive values of tumor budding in a randomized controlled trial evaluating the superiority of adjuvant chemotherapy with oral tegafur-uracil over surgery alone for stage II colon cancer (SACURA trial; ClinicalTrials.gov identifier: NCT00392899).
PATIENTS AND METHODS
Between 2006 and 2010, we enrolled 991 patients from 123 institutions with stage II colon cancer. Tumor budding was diagnosed by central review on the basis of the criteria adopted in the ITBCC2016. We prospectively recorded all clinical and pathologic data, including the budding grade, and performed prognostic analyses after 5 years of completing the patients' registration.
RESULTS
Of 991 tumors, 376, 331, and 284 were classified as BD1, BD2, and BD3, respectively; the 5-year relapse-free survival (RFS) rate was 90.9%, 85.1%, and 74.4%, respectively ( P < .001), and ranged widely in T4 tumors (86.6% to 53.3%). The budding grade significantly correlated with recurrence in the liver, lungs, lymph nodes, and peritoneum ( P < .001 to .01). Multivariable analysis revealed that budding and T stage exerted an independent impact on RFS, and on the basis of the Harrell concordance index, these two factors substantially contributed to the improvement of the Cox model for predicting RFS. Both the BD2 and BD3 groups demonstrated greater improvement in the 5-year recurrence rate in the adjuvant chemotherapy group than the surgery-alone group by approximately 5%, but the difference was statistically nonsignificant.
CONCLUSION
Tumor budding grade on the basis of the ITBCC2016 criteria should be routinely evaluated in pathologic practice and could improve the benefit of adjuvant chemotherapy for stage II colon cancer.",2019,"Both the BD2 and BD3 groups demonstrated greater improvement in the 5-year recurrence rate in the adjuvant chemotherapy group than the surgery-alone group by approximately 5%, but the difference was statistically nonsignificant.
","['991 patients from 123 institutions with stage II colon cancer', 'Stage II Colon Cancer', 'Between 2006 and 2010']",['adjuvant chemotherapy with oral tegafur-uracil over surgery alone'],"['5-year recurrence rate', 'BD1, BD2, and BD3', '5-year relapse-free survival (RFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0041917', 'cui_str': 'Uracil'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",991.0,0.175321,"Both the BD2 and BD3 groups demonstrated greater improvement in the 5-year recurrence rate in the adjuvant chemotherapy group than the surgery-alone group by approximately 5%, but the difference was statistically nonsignificant.
","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ueno', 'Affiliation': '1National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Ishiguro', 'Affiliation': '2Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Nakatani', 'Affiliation': '3Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Hyogo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': '2Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': '2Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Matsuda', 'Affiliation': '4Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Nakamoto', 'Affiliation': '5Kobe City Medical Center West Hospital, Hyogo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kotake', 'Affiliation': '6Kouseiren Takaoka Hospital, Toyama, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Kurachi', 'Affiliation': '7Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Egawa', 'Affiliation': '8Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Yasumasa', 'Affiliation': '9Japan Community Health Care Organization Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': '10Suita Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ikawa', 'Affiliation': '11Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Shinji', 'Affiliation': '12Nippon Medical School Chiba Hokusoh Hospital, Chiba, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': '13Kurume University, Fukuoka, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': '14Nagoya University, Aichi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Teramukai', 'Affiliation': '15Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': '16Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': '2Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02059']
2357,30768411,A Longitudinal Follow-up Study Examining Adolescent Depressive Symptoms as a Function of Prior Anxiety Treatment.,"OBJECTIVE
Children who are fearful and anxious are at heightened risk for developing depression in adolescence. Treating anxiety disorders in pre-/early adolescence may be one mechanism through which depressive symptoms later in adolescence can be prevented. We hypothesized that anxious youth who responded positively to cognitive-behavioral therapy (CBT) for anxiety would show reduced onset of depressive symptoms 2 years later compared to treatment nonresponders, and that this effect would be specific to youth treated with CBT compared to an active supportive comparison treatment.
METHOD
Participants were 80 adolescents ages 11 to 17 years who had previously completed a randomized trial comparing predictors of treatment response to CBT and child-centered therapy (CCT). Youth met DSM-IV criteria for generalized, separation, and/or social anxiety disorder at the time of treatment. The present study was a prospective naturalistic 2-year follow-up examining trajectories toward depression, in which participants were reassessed for depressive symptoms 2 years after anxiety treatment. Treatment response was defined as a 35% reduction in independent evaluator-rated anxiety severity on the Pediatric Anxiety Rating Scale after treatment.
RESULTS
As hypothesized, lower levels of depressive symptoms were observed in anxious youth who responded to CBT for anxiety (β = -0.807, p = .004) but not CCT (β = 0.254, p = .505). Sensitivity analyses showed that the effects were driven by girls.
CONCLUSION
Findings suggest that CBT for anxiety is a promising approach to preventing adolescent depressive symptomatology, especially among girls. The results highlight the need for better early screening for anxiety and better dissemination of CBT programs targeting anxiety in youth.",2019,"Treatment response was defined as a 35% reduction in independent evaluator-rated anxiety severity on the Pediatric Anxiety Rating Scale after treatment.
","['Children who are fearful and anxious are at heightened risk for developing depression in adolescence', 'participants were reassessed for depressive symptoms 2 years after anxiety treatment', 'Participants were 80 adolescents ages 11 to 17 years who had previously completed']","['CBT and child-centered therapy (CCT', 'cognitive-behavioral therapy (CBT', 'CBT']","['depressive symptoms', 'Pediatric Anxiety Rating Scale', 'adolescent depressive symptomatology']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0442803', 'cui_str': 'Heightened (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",80.0,0.0264559,"Treatment response was defined as a 35% reduction in independent evaluator-rated anxiety severity on the Pediatric Anxiety Rating Scale after treatment.
","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Silk', 'Affiliation': 'University of Pittsburgh, PA. Electronic address: jss4@pitt.edu.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Price', 'Affiliation': 'University of Pittsburgh, PA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Rosen', 'Affiliation': 'University of Pittsburgh, PA.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Ryan', 'Affiliation': 'University of Pittsburgh, PA.'}, {'ForeName': 'Erika E', 'Initials': 'EE', 'LastName': 'Forbes', 'Affiliation': 'University of Pittsburgh, PA.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Siegle', 'Affiliation': 'University of Pittsburgh, PA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Dahl', 'Affiliation': 'School of Public Health, University of California at Berkeley, CA.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'McMakin', 'Affiliation': ""Florida International University, Miami, FL; Nicklaus Children's Hospital, Miami, FL.""}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Temple University, Philadelphia, PA.'}, {'ForeName': 'Cecile D', 'Initials': 'CD', 'LastName': 'Ladouceur', 'Affiliation': 'University of Pittsburgh, PA.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.10.012']
2358,30295295,"Interventional femoral ""crossover"" bypass for peripheral ischaemia under cardiocirculatory support with the Impella CP heart pump.",,2020,,[],[],[],[],[],[],,0.0134604,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Geyer', 'Affiliation': 'Center for Cardiology, Cardiology I, Heart Center and German Center for Cardiovascular Research (DZHK), Partner Site Rhein-Main, University Medical Center Mainz (Johannes Gutenberg-University Mainz), Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vosseler', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-18-00797']
2359,17651563,Substituting virtual reality trainers for inanimate box trainers does not decrease laparoscopic skills acquisition.,"OBJECTIVES
Inanimate and virtual reality box training help in developing basic laparoscopic skills. The lack of tactile feedback and lack of reality may be a detriment when training with virtual reality trainers. This study examined the hypothesis that there is no difference in laparoscopic skills acquisition when virtual reality trainers are partially substituted for inanimate box trainers.
METHODS
Medical students without laparoscopic experience were randomized into either Group A or Group B. Group A performed tasks on the LTS 2000 (an inanimate box trainer) alone for 10 sessions. Group B performed tasks on the box trainer as well as on the MIST-VR (a virtual reality trainer) for 10 sessions. Scores for 5 inanimate box trainer exercises (time and errors) for the first and tenth sessions were compared between both groups.
RESULTS
No statistical differences were seen in any exercises in the first session between Group A (n=14) and Group B (n=18) in either time or errors (P=NS for all comparisons). Mean times decreased in both groups from the first session to the last session. At the last session, again both groups demonstrated no differences in any of the exercises (P=NS for all comparisons).
CONCLUSIONS
No difference was found in laparoscopic skills acquisition when incorporating virtual reality trainers into a curriculum based on inanimate box trainers. Ideally, laparoscopic training laboratories should include both virtual reality and inanimate trainers.",2007,No difference was found in laparoscopic skills acquisition when incorporating virtual reality trainers into a curriculum based on inanimate box trainers.,['Medical students without laparoscopic experience'],['Group A or Group B. Group'],"['Mean times', 'laparoscopic skills acquisition']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0245111,No difference was found in laparoscopic skills acquisition when incorporating virtual reality trainers into a curriculum based on inanimate box trainers.,"[{'ForeName': 'Atul K', 'Initials': 'AK', 'LastName': 'Madan', 'Affiliation': 'Department of Surgery, University of Tennessee Health Science Center, Memphis, Tennessee 38163, USA. amadan@utmem.edu'}, {'ForeName': 'Constantine T', 'Initials': 'CT', 'LastName': 'Frantzides', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2360,32428865,"Remdesivir in COVID-19: A critical review of pharmacology, pre-clinical and clinical studies.","BACKGROUND & AIMS
Remdesivir is a broad spectrum anti-viral drug that has shown to inhibit SARS-CoV-2, in vitro and in vivo. In absence of any effective treatment for SARS-CoV-2 infection (COVID-19), remdesivir has been tried for a compassionate use in severe COVID-19. Newer randomized controlled studies that have recently become available, showed a mixed result. We aimed to systematically search the literature to understand the pharmacology and clinical effects of remdesivir in patients with COVID-19.
METHODS
We systematically searched the PubMed, ClinicalTrial.Org and MedRxiv database up till May 5, 2020 using specific key words such as ""Remdesivir"" or 'GS-5734″ AND ""COVID-19"" or ""SARS-CoV-2"" and retrieved all the article published in English language, that have reported the pharmacology and the clinical outcomes of remdesivir in patients with COVID-19.
RESULTS
Initial compassionate use of remdesivir has shown a fairly good result, but difficult to quantify, in the absence of control arm. While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
CONCLUSIONS
Remdesivir has shown a mixed result in patients with COVID-19 with an acceptable side effect. However, jury is still out while awaiting the results from the forthcoming trials.",2020,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
","['Remdesivir in COVID-19', 'patients with COVID-19']",['placebo'],['mortality'],"[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.151411,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
","[{'ForeName': 'Awadhesh Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Diabetes & Endocrinology, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India. Electronic address: draksingh_2001@yahoo.com.'}, {'ForeName': 'Akriti', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'College of Medicine and JNM Hospital, Kalyani, Nadia, West Bengal, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Gynaecology & Obstetrics, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Fortis C-DOC Hospital for Diabetes and Allied Sciences, New Delhi, India.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.018']
2361,17663093,"Laparoscopic appendectomy in patients with a body mass index of 25 or greater: results of a double blind, prospective, randomized trial.","BACKGROUND
The reported advantages of the laparoscopic approach to appendectomy are shortened hospital stay, less postoperative pain, and earlier return to usual activities (work). However, a prospective, randomized, double-blind trial comparing laparoscopic appendectomy with open appendectomy in active-duty males failed to disclose a benefit of laparoscopic appendectomy with regards to postoperative pain and return to work. The aim of our study was to compare open and laparoscopic appendectomy in overweight patients.
METHODS
We conducted a prospective, randomized, double-blind study to determine whether laparoscopic appendectomy or the open procedure in overweight patients offers a significant reduction in lost workdays, postoperative pain, or operative time from. Open appendectomy in overweight patients (those with a body mass index > or =25) may be more difficult due to excessive subcutaneous adipose tissue. The open incision may be of considerable size, which may result in increased postoperative pain and a prolonged convalescence.
RESULTS
There was a statistically significant increase in operative time for laparoscopic appendectomy of 11 minutes. As expected, the aggregate incision length for open appendectomy was twice that of the laparoscopic appendectomy.
CONCLUSION
The data from this prospective, randomized, double-blind study failed to demonstrate any significant reduction in lost workdays, postoperative pain, or operative time with laparoscopic appendectomy.",2007,"The data from this prospective, randomized, double-blind study failed to demonstrate any significant reduction in lost workdays, postoperative pain, or operative time with laparoscopic appendectomy.","['patients with a body mass index of 25 or greater', 'overweight patients (those with a body mass index > or =25', 'active-duty males', 'overweight patients']","['laparoscopic appendectomy with open appendectomy', 'Laparoscopic appendectomy', 'Open appendectomy', 'laparoscopic appendectomy']","['lost workdays, postoperative pain, or operative time from', 'lost workdays, postoperative pain, or operative time with laparoscopic appendectomy', 'operative time', 'postoperative pain', 'aggregate incision length']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",,0.523049,"The data from this prospective, randomized, double-blind study failed to demonstrate any significant reduction in lost workdays, postoperative pain, or operative time with laparoscopic appendectomy.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ricca', 'Affiliation': 'Department of General Surgery, Naval Medical Center, Portsmouth, Virginia 23708, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Brar', 'Affiliation': ''}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Lucha', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2362,30871894,In-hospital physiotherapy improves physical activity level after lung cancer surgery: a randomized controlled trial.,"OBJECTIVES
Patients undergoing lung cancer surgery are routinely offered physiotherapy. Despite its routine use, effects on postoperative physical recovery have yet not been demonstrated. The aim of this study was to investigate whether physiotherapy could improve postoperative in-hospital physical activity level and physical capacity.
DESIGN
Single-blind randomized controlled trial.
SETTING
Thoracic surgery department at a University Hospital.
PARTICIPANTS
Patients undergoing elective thoracic surgery (n=94) for confirmed or suspected lung cancer were assessed during hospital stay.
INTERVENTION
Daily physiotherapy, consisting of mobilization, ambulation, shoulder exercises and breathing exercises. The control group received no physiotherapy treatment.
OUTCOMES
In-hospital physical activity assessed with the Actigraph GT3X+ accelerometer, six-minute walk test, spirometry and dyspnea scores.
RESULTS
The treatment group reached significantly more accelerometer counts (2010 (1508) vs 1629 (1146), mean difference 495 [95% CI 44 to 1109]), and steps per hour (49 (47) vs 37 (34), mean difference 14 [95% CI 3 to 30]), compared to the control group, during the first three postoperative days. No significant differences in six-minute walk test (percent of preoperative 71% vs 79%, P=0.13), spirometry (FEV1 percent of preoperative 69% vs 69%, P=0.83) or dyspnoea (M-MRC 2 vs 2, P=0.74) between the groups were found.
CONCLUSIONS
Patients receiving in-hospital physiotherapy showed increased level of physical activity during the first days after lung cancer surgery, compared to an untreated control group. However, no effects on the six-minute walk test or spirometric values were found. The clinical importance of an increased physical activity level during the early postoperative period needs to be further evaluated.
CLINICAL TRIAL REGISTRATION NUMBER
NCT01961700.",2019,"No significant differences in six-minute walk test (percent of preoperative 71% vs 79%, P=0.13), spirometry (FEV1 percent of preoperative 69% vs 69%, P=0.83) or dyspnoea (M-MRC 2 vs 2, P=0.74) between the groups were found.
","['Patients undergoing lung cancer surgery', 'Thoracic surgery department at a University Hospital', 'Patients undergoing elective thoracic surgery (n=94) for confirmed or suspected lung cancer were assessed during hospital stay', 'lung cancer surgery']","['physiotherapy', 'Daily physiotherapy, consisting of mobilization, ambulation, shoulder exercises and breathing exercises', 'no physiotherapy treatment']","['six-minute walk test', 'level of physical activity', 'postoperative in-hospital physical activity level and physical capacity', 'six-minute walk test or spirometric values', 'hospital physical activity assessed with the Actigraph GT3X+ accelerometer, six-minute walk test, spirometry and dyspnea scores', 'physical activity level', 'dyspnoea', 'accelerometer counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0587506', 'cui_str': 'Thoracic surgery department (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0581834', 'cui_str': 'Suspected lung cancer'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0454323', 'cui_str': 'Shoulder exercises (regime/therapy)'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.158624,"No significant differences in six-minute walk test (percent of preoperative 71% vs 79%, P=0.13), spirometry (FEV1 percent of preoperative 69% vs 69%, P=0.83) or dyspnoea (M-MRC 2 vs 2, P=0.74) between the groups were found.
","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Jonsson', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine and Health, Örebro University, SE-70182 Örebro, Sweden. Electronic address: marcus.jonsson@oru.se.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hurtig-Wennlöf', 'Affiliation': 'School of Health Sciences, Department of Medical Diagnostics, Faculty of Medicine and Health, Örebro University, SE-70182 Örebro, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ahlsson', 'Affiliation': 'Cardiovascular Division, Karolinska University Hospital, SE-17176 Stockholm, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Vidlund', 'Affiliation': 'Department of Vascular and Cardiothoracic Surgery, Faculty of Medicine and Health, Örebro University, SE-70182 Örebro, Sweden.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, SE-17177 Stockholm, Sweden; Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, SE-70182 Örebro, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Westerdahl', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine and Health, Örebro University, SE-70182 Örebro, Sweden.'}]",Physiotherapy,['10.1016/j.physio.2018.11.001']
2363,32428843,Aquatic exercising may improve sexual function in females with multiple sclerosis - an exploratory study.,"BACKGROUND
Persons with multiple sclerosis (PwMS) report impaired sexual function, and this is particularly prevalent and burdensome for females with MS. The present study included a randomized controlled trial (RCT) design and examined the effect of aquatic exercise training on sexual function among females with MS.
METHODS
The sample consisted of 60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75) who were randomly assigned into one of the following conditions: aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC). Participants completed questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction before and after the 8-week study period.
RESULTS
The interventions had significant and positive effects on the overall score of sexual function (p < .001, η ρ 2 = .35), all subscales (desire (p = .002, 2 = .20), arousal (p = .01, 2 =.15), lubrication (p = .011, 2 = .15), orgasm (p = .007, 2 = .16), satisfaction (p = .023, 2 = .13), pain (p = .02, 2 = .13)) and depression (p =.002, 2 = .20).The interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
CONCLUSIONS
Aquatic exercise training may improve sexual function among female PwMS, but this requires further examination using a large sample pre-screened for sexual dysfunction. If confirmed, the present findings are of clinical and practical importance for females with MS.",2020,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","['Persons with multiple sclerosis (PwMS', 'females with multiple sclerosis', 'females with MS.\nMETHODS', 'females with MS', '60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75']","['Aquatic exercise training', 'aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC', 'aquatic exercise training', 'Aquatic exercising']","['arousal', 'overall score of sexual function', 'fatigue', 'sleep complaints', 'couple satisfaction', 'questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction', 'sexual function', 'satisfaction', 'pain', 'depression', 'lubrication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C4517514', 'cui_str': '1.75'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.044883,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran. Electronic address: dena.sadeghibahmani@upk.ch.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Razazian', 'Affiliation': 'Kermanshah University of Medical Sciences, Neurology Department, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, Kermanshah, Iran; University of Basel, Department of Sport, Exercise, and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102106']
2364,32428636,Non-Pharmacological interventions for the anxiety in patients with dementia. A cross-over randomised controlled trial.,"BACKGROUND
Behavioural and Psychiatric Symptoms in dementia (BPSD) tend to be a crucial and big problem in dementia. Anxiety several times remains under-diagnosed because it is often considered to be a psychological response to cognitive decline. As only the 10 % of patients were correctly treated, the pharmacological treatment should be well- considered. The aim of this study was to evaluate three non-pharmacological interventions for the treatment of anxiety in dementia.
METHODS
A cross-over randomised controlled trial with 60 participants (different types and stages of dementia) conducted in Greece. The sample was randomly assigned to 6 different groups of 10 participants each. The non-pharmacological interventions that have been evaluated are: a) Music Therapy b) Exercise and c) Aromatherapy & Massage. The measurements that were used are: MMSE, ACE-R, GDS, FRSSD and NPI questionnaire. The interventions lasted 5 days and there was two days off as a wash-out period. There was no drop-out rate.
RESULTS
The study showed that the most effective intervention is Music therapy. The second most effective intervention is Exercise and the third one is Aromatherapy and Massage. In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results. (p = <0.05, p = 0.55, accordingly). Caregivers' burden also reduced with MT. In the parenthesis p results indicate Music Therapy's p is less than 0.05 in comparison with the two other interventions and therefore the sequence of the interventions does not interfere with the results, as well (p = <0.05, p = 0.19).
CONCLUSIONS
Our results are in accordance with the current literature. Music Therapy is a promising alternative intervention for the treatment of anxiety in PwD. Music Therapy is an effective non-pharmacological treatment for the reduction of the caregivers' burden, because of the anxiety symptoms in PwD, such as lack of sleep, lack of personal time, unhealthy lifestyle, lack of solutions on what to do with their patients etc. The type of music, the duration of the intervention and the long-term benefits remain unclear. There is a big need of further research with stronger possible evaluation methods.",2020,In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results.,"['60 participants (different types and stages of dementia) conducted in Greece', 'dementia (BPSD', 'patients with dementia', 'anxiety in dementia']","['Music Therapy', 'Music Therapy b) Exercise and c) Aromatherapy & Massage']","['MMSE, ACE-R, GDS, FRSSD and NPI questionnaire']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.0553418,In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results.,"[{'ForeName': 'Tatiana-Danai', 'Initials': 'TD', 'LastName': 'Dimitriou', 'Affiliation': 'Aristotle University of Thessaloniki, 44 Salaminos Street, Halandri, 15232, Athens, Greece. Electronic address: tt.kirxof@gmail.com.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Verykouki', 'Affiliation': 'Department of Hygiene, Social Preventive Medicine and Medical Statistics, School of Medicine, Aristotle University of Thessaloniki, University Campus, 54124, Thessaloniki, Makedonia, Greece. Electronic address: e.verykouki@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Papatriantafyllou', 'Affiliation': ""3rd Age Center IASIS, 2nd Neurology Dpt., University of Athens, 'Attikon' Hospital, 73 Krimeas Str., Glyfada, Athens, Greece. Electronic address: jpapatriantafyllou@gmail.com.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Konsta', 'Affiliation': '1st Department of Psychiatry, ""Papageorgiou"" General Hospital of Thessaloniki, Aristotle University of Thessaloniki, Greece. Electronic address: konstaa@auth.gr.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kazis', 'Affiliation': '3rd Neurology Department, Aristotle University of Thessaloníki, Greece. Electronic address: dimitrios.kazis@gmail.com.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Tsolaki', 'Affiliation': '1st Department of Neurology, Aristotle University of Thessaloniki, Makedonia, 3 Despere Street, Thessaloniki, Greece. Electronic address: tsolakim1@gmail.com.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112617']
2365,17575757,Randomized prospective study of totally extraperitoneal inguinal hernia repair: fixation versus no fixation of mesh.,"BACKGROUND
Fixation of the mesh during laparoscopic totally extraperitoneal (TEP) inguinal hernia repair is thought to be necessary to prevent recurrence. However, mesh fixation may increase postoperative pain and lead to an increased risk of complications. We questioned whether elimination of fixation of the mesh during TEP inguinal hernia repair leads to decreased postoperative pain or complications, or both, without an increased rate of recurrence.
METHODS
A randomized prospective single-blinded study was carried out in 40 patients who underwent laparoscopic TEP inguinal hernia repair with (Group A=20) or without (Group B=20) fixation of the mesh.
RESULTS
Patients in whom the mesh was not fixed had shorter hospital length of stay (8.3 vs 16.0 hours, P=0.01), were less likely to be admitted to the hospital (P=0.001), used less postoperative narcotic analgesia in the PACU (P=0.01), and were less likely to develop urinary retention (P=0.04). No significant differences occurred in the level of pain, time to return to normal activity, or the difficulty of the operation between the 2 groups. No hernia recurrences were observed in either group (follow-up range, 6 to 30 months, median=19).
CONCLUSIONS
Elimination of tack fixation of mesh during laparoscopic TEP inguinal hernia repair significantly reduces the use of postoperative narcotic analgesia, hospital length of stay, and the development of postoperative urinary retention but does not lead to a significant reduction in postoperative pain. Eliminating tacks does not lead to an increased rate of recurrence.",2006,"No hernia recurrences were observed in either group (follow-up range, 6 to 30 months, median=19).
",['40 patients who underwent'],"['laparoscopic totally extraperitoneal', 'laparoscopic TEP inguinal hernia repair with (Group A=20) or without (Group B=20) fixation of the mesh', 'totally extraperitoneal inguinal hernia repair: fixation versus no fixation of mesh']","['postoperative narcotic analgesia', 'rate of recurrence', 'postoperative narcotic analgesia, hospital length of stay, and the development of postoperative urinary retention', 'risk of complications', 'hernia recurrences', 'postoperative pain or complications', 'level of pain, time to return to normal activity, or the difficulty of the operation', 'shorter hospital length of stay', 'postoperative pain', 'urinary retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442090', 'cui_str': 'Extraperitoneal (qualifier value)'}, {'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",40.0,0.0963002,"No hernia recurrences were observed in either group (follow-up range, 6 to 30 months, median=19).
","[{'ForeName': 'Cody A', 'Initials': 'CA', 'LastName': 'Koch', 'Affiliation': 'Mayo Medical School, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Greenlee', 'Affiliation': ''}, {'ForeName': 'Dirk R', 'Initials': 'DR', 'LastName': 'Larson', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Farley', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2366,17575754,Prospective randomized trial of right-sided paracolic adhesiolysis for chronic pelvic pain.,"BACKGROUND
Prior study has shown that right paracolic adhesions are found in 90% of patients with chronic pelvic pain and less frequently in pain-free patients. We set out to determine whether paracolic adhesiolysis will reduce site-specific pain.
METHODS
This was a prospective, randomized trial of right paracolic adhesiolysis at the time of diagnostic and operative laparoscopy for chronic pelvic pain. Twenty-five patients with a diagnosis of chronic pelvic pain were randomized to either undergo or withhold lysis of right paracolic adhesions at the time of operative laparoscopy.
RESULTS
Right paracolic adhesions were found in 100% of our patients. For all subjects, there was a significant reduction of right and left lower quadrant pain (P<0.001) following the operative laparoscopy. Those who underwent right paracolic adhesiolysis had significantly greater right pelvic pain reduction than those who did not (P=0.014). There was no difference in the reduction of left or mid pelvic pain between the treatment and control groups.
CONCLUSIONS
Right paracolic adhesiolysis reduces short-term site-specific tenderness in patients with chronic pelvic pain. Patients who would benefit from diagnostic or operative laparoscopy are likely to benefit further from paracolic adhesiolysis.",2006,"For all subjects, there was a significant reduction of right and left lower quadrant pain (P<0.001) following the operative laparoscopy.","['Twenty-five patients with a diagnosis of chronic pelvic pain', 'Patients who would benefit from diagnostic or operative laparoscopy are likely to benefit further from paracolic adhesiolysis', 'chronic pelvic pain', 'patients with chronic pelvic pain']","['undergo or withhold lysis of right paracolic adhesions', 'right-sided paracolic adhesiolysis']","['right and left lower quadrant pain', 'Right paracolic adhesions', 'short-term site-specific tenderness', 'right pelvic pain reduction', 'reduction of left or mid pelvic pain']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0442135', 'cui_str': 'Paracolic (qualifier value)'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}]","[{'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0442135', 'cui_str': 'Paracolic (qualifier value)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0442135', 'cui_str': 'Paracolic (qualifier value)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}]",25.0,0.019984,"For all subjects, there was a significant reduction of right and left lower quadrant pain (P<0.001) following the operative laparoscopy.","[{'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Keltz', 'Affiliation': ""Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology, St. Luke's-Roosevelt Hospital Center, Columbia College of Physicians and Surgeons, New York, New York 10019, USA.""}, {'ForeName': 'Puja Sharma', 'Initials': 'PS', 'LastName': 'Gera', 'Affiliation': ''}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Olive', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2367,32119692,Language effects on bargaining.,"Language is critical to coordination in groups. Though, how language affects coordination in groups is not well understood. We prime distributive and integrative language in a bargaining experiment to better understand the links between group outcomes and communication. We accomplish this by priming interests or positions language in randomized groups. We find that priming positions as opposed to interests language leads to agreements where controllers, subjects with unilateral authority over the group outcome, receive a larger share of the benefits but where the total benefits to the group are unaffected. In contrast to common justifications for the use of integrative language in bargaining, our experimental approach revealed no significant differences between priming interests and positions language in regards to increasing joint outcomes for the groups. Across treatments, we find subjects that use gain frames and make reference to visuals aids during bargaining experience larger gains for the group, while loss frames and pro-self language experience larger gains for the individual through side payments. This finding suggests a bargainer's dilemma: whether to employ language that claims a larger share of group's assets or employ language to increase joint gains.",2020,"In contrast to common justifications for the use of integrative language in bargaining, our experimental approach revealed no significant differences between priming interests and positions language in regards to increasing joint outcomes for the groups.",[],[],[],[],[],[],,0.0233567,"In contrast to common justifications for the use of integrative language in bargaining, our experimental approach revealed no significant differences between priming interests and positions language in regards to increasing joint outcomes for the groups.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Weir', 'Affiliation': 'Dept. of Environmental and Natural Resource Economics, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Ashcraft', 'Affiliation': 'Natural Resources and the Environment, University of New Hampshire, Durham, NH, United States of America.'}, {'ForeName': 'Natallia', 'Initials': 'N', 'LastName': 'Leuchanka Diessner', 'Affiliation': 'Natural Resources and the Environment, University of New Hampshire, Durham, NH, United States of America.'}, {'ForeName': 'Bridie', 'Initials': 'B', 'LastName': 'McGreavy', 'Affiliation': 'Department of Communication and Journalism, University of Maine, Orono, ME, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Vogler', 'Affiliation': 'Rhode Island School of Design, Providence, RI, United States of America.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Guilfoos', 'Affiliation': 'Dept. of Environmental and Natural Resource Economics, University of Rhode Island, Kingston, RI, United States of America.'}]",PloS one,['10.1371/journal.pone.0229501']
2368,31884564,24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients.,"OBJECTIVE
The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG).
METHODS
This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs).
RESULTS
At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
CONCLUSIONS
Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364.",2020,"After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
","['Glaucoma Patients', 'patients with open-angle glaucoma (OAG', 'adult patients with OAG (N\xa0=\u200975) received']","['topical bimatoprost 0.03% once daily', 'Bimatoprost SR', 'Bimatoprost Sustained-Release Implant (Bimatoprost SR', 'biodegradable bimatoprost sustained-release implant (Bimatoprost SR']","['safety and intraocular pressure (IOP)-lowering effects', 'overall AE incidence', 'adverse events (AEs', 'IOP change', 'favorable efficacy and safety profiles', 'mean IOP reduction']","[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C4517402', 'cui_str': '0.03 (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.167087,"After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
","[{'ForeName': 'E Randy', 'Initials': 'ER', 'LastName': 'Craven', 'Affiliation': 'Johns Hopkins University School of Medicine, 600 N. Wolfe Street, 110, Baltimore, MD, 21287, USA. erandycraven@gmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walters', 'Affiliation': 'Keystone Research, Ltd, Austin, TX, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Christie', 'Affiliation': 'Scott & Christie and Associates, Pittsburgh, PA, USA.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Day', 'Affiliation': 'Coastal Research Associates, Roswell, GA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Sacramento Eye Consultants, Sacramento, CA, USA.'}, {'ForeName': 'Margot L', 'Initials': 'ML', 'LastName': 'Goodkin', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Wangsadipura', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Robinson', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bejanian', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drugs,['10.1007/s40265-019-01248-0']
2369,31375279,Randomised Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Positive Margins or Extracapsular Extension.,"BACKGROUND
It remains unclear whether patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy.
OBJECTIVE
To compare the effectiveness and tolerability of adjuvant radiotherapy following radical prostatectomy.
DESIGN, SETTING, AND PARTICIPANTS
This was a randomised, open-label, parallel-group trial. A total of 250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion.
INTERVENTION
A total of 126 patients received adjuvant radiotherapy at 66.6Gy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary endpoint was biochemical recurrence-free survival, which we analysed using the Kaplan-Meier method and Cox proportional hazard regression. Overall survival, cancer-specific survival, local recurrence, and adverse events were secondary endpoints.
RESULTS AND LIMITATIONS
The median follow-up time for patients who were alive when the follow-up ended was 9.3yr in the adjuvant group and 8.6yr in the observation group. The 10-yr survival for biochemical recurrence was 82% in the adjuvant group and 61% in the observation group (hazard ratio [HR] 0.26 [95% confidence interval {CI} 0.14-0.48], p<0.001), and for overall survival 92% and 87%, respectively (HR 0.69 [95% CI 0.29-1.60], p=0.4). Two and four metastatic cancers occurred, respectively. Out of the 43 patients with biochemical recurrence in the observation group, 37 patients received salvage radiotherapy. In the adjuvant group, 56% experienced grade 3 adverse events, versus 40% in the observation group (p=0.016). Only one grade 4 adverse event occurred (adjuvant group). A limitation of this study was the number of patients.
CONCLUSIONS
Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
PATIENT SUMMARY
Radiotherapy given immediately after prostate cancer surgery prolongs prostate-specific antigen progression-free survival, but causes more adverse events, when compared with surgery alone.",2019,"Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
","['250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion', '43 patients with biochemical recurrence in the observation group, 37 patients received', 'patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy', 'Prostate Cancer Patients with Positive Margins or Extracapsular Extension', '126 patients received', 'patients with positive margins or extracapsular extension']","['Radical Prostatectomy Versus Radical Prostatectomy Alone', 'Adjuvant radiotherapy', 'radical prostatectomy alone', 'adjuvant radiotherapy', 'Radiotherapy', 'Adjuvant Radiotherapy', 'salvage radiotherapy']","['Overall survival, cancer-specific survival, local recurrence, and adverse events', 'overall survival', '10-yr survival for biochemical recurrence', 'effectiveness and tolerability', 'grade 3 adverse events', 'tolerated and prolongs biochemical recurrence-free survival', 'biochemical recurrence-free survival', 'median follow-up time']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4042485', 'cui_str': 'Pt(acac)2'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0036628', 'cui_str': 'Seminal Vesicles'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",250.0,0.344689,"Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
","[{'ForeName': 'Greetta', 'Initials': 'G', 'LastName': 'Hackman', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'Department of Surgery, Tampere University Hospital, Faculty of Medicine and Life Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Matikainen', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Kouri', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Joensuu', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland; Docrates Cancer Center, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Luukkaala', 'Affiliation': 'Research, Development and Innovation Center, Tampere University Hospital and Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Salonen', 'Affiliation': 'Department of Urology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Isotalo', 'Affiliation': 'Department of Urology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Pétas', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Niilo', 'Initials': 'N', 'LastName': 'Hendolin', 'Affiliation': 'Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Boström', 'Affiliation': 'Department of Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Aaltomaa', 'Affiliation': 'Department of Urology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lehtoranta', 'Affiliation': 'Department of Urology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Hellström', 'Affiliation': 'Department of Urology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riikonen', 'Affiliation': 'Department of Surgery, Tampere University Hospital, Faculty of Medicine and Life Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Korpela', 'Affiliation': 'Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Minn', 'Affiliation': 'Department of Oncology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Pirkko-Liisa', 'Initials': 'PL', 'LastName': 'Kellokumpu-Lehtinen', 'Affiliation': 'Department of Oncology, Tampere University Hospital, Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Pukkala', 'Affiliation': 'Finnish Cancer Registry-Institute for Statistical and Epidemiological Cancer Research, Helsinki, Finland; Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Akseli', 'Initials': 'A', 'LastName': 'Hemminki', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland; Docrates Cancer Center, Helsinki, Finland; Cancer Gene Therapy Group, Translational Immunology Research Program, University of Helsinki, Helsinki, Finland. Electronic address: akseli.hemminki@helsinki.fi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.07.001']
2370,32428983,Dietary interventions for multiple sclerosis-related outcomes.,"BACKGROUND
Multiple sclerosis (MS) is a common demyelinating disease of the central nervous system. Although the exact pathogenesis remains unknown, the leading theory is that it results from immune system dysregulation. Approved disease-modifying therapy appears to modulate the immune system to improve MS-related outcomes. There is substantial interest in the ability of dietary interventions to influence MS-related outcomes. This is an update of the Cochrane Review 'Dietary interventions for multiple sclerosis' (Farinotti 2003; Farinotti 2007; Farinotti 2012).
OBJECTIVES
To assess the effects of dietary interventions (including dietary plans with recommendations for specific whole foods, macronutrients, and natural health products) compared to placebo or another intervention on health outcomes (including MS-related outcomes and serious adverse events) in people with MS.
SEARCH METHODS
On 30 May 2019, we searched CENTRAL, MEDLINE, Embase, and Web of Science. We also searched ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform (ICTRP), and Networked Digital Library of Theses and Dissertations (NDLTD). We checked reference lists in identified trials and requested information from trial authors to identify any additional published or unpublished data.
SELECTION CRITERIA
We included any randomized controlled trial (RCT) or controlled clinical trial (CCT) examining the effect of a dietary intervention versus placebo or another intervention among participants with MS on MS-related outcomes, including relapses, disability progression, and magnetic resonance imaging (MRI) measures.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Planned primary outcomes were number of participants experiencing relapse and change in disability progression, according to a validated disability scale at the last reported follow-up. Secondary outcomes included MRI activity, safety, and patient-reported outcomes. We entered and analysed data in Review Manager 5.
MAIN RESULTS
We found 41 full-text articles examining 30 trials following full-text review. Participants were adults with MS, defined by established criteria, presenting to MS clinics in Europe, North America, and the Middle East. Study design varied considerably, although all trials had at least one methodological issue leading to unknown or high risk of bias. Trials examined: supplementation to increase polyunsaturated fatty acids (PUFAs) (11 trials); a variety of antioxidant supplements (10 trials); dietary programmes (3 trials); and other dietary supplements (e.g. acetyl L-carnitine, biotin, creatine, palmitoylethanolamide, probiotic, riboflavin) (6 trials). In three trials comparing PUFAs with monounsaturated fatty acids (MUFAs), the evidence was very uncertain concerning difference in relapses (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.88 to 1.20; 3 studies, 217 participants; 75% in the PUFA group versus 74% in the MUFA group; very low-certainty evidence). Among four trials comparing PUFAs with MUFAs, there may be little to no difference in global impression of deterioration (RR 0.85, 95% CI 0.71 to 1.03; 4 studies, 542 participants; 40% in the PUFA group versus 47% in the MUFA group; low-certainty evidence). In two trials comparing PUFAs with MUFAs (102 participants), there was very low-certainty evidence for change in disability progression. None of the PUFA versus MUFA trials examined MRI outcomes. In one trial comparing PUFAs with MUFAs (40 participants), there were no serious adverse events; based on low-certainty evidence. In two trials comparing different PUFAs (omega-3 versus omega-6), there may be little to no difference in relapses (RR 1.02, 95% CI 0.62 to 1.66; 2 studies, 129 participants; 30% in the omega-3 versus 29% in the omega-6 group; low-certainty evidence). Among three trials comparing omega-3 with omega-6, there may be little to no difference in change in disability progression, measured as mean change in Expanded Disability Status Scale (EDSS) (mean difference (MD) 0.00, 95% CI -0.30 to 0.30; 3 studies, 166 participants; low-certainty evidence). In one trial comparing omega-3 with omega-6, there was likely no difference in global impression of deterioration (RR 0.99, 95% CI 0.51 to 1.91; 1 study, 86 participants; 29% in omega-3 versus 29% in omega-6 group; moderate-certainty evidence). In one trial comparing omega-3 with omega-6 (86 participants), there was likely no difference in number of new T1- weighted gadolinium-enhancing lesions, based on moderate-certainty evidence. In four trials comparing omega-3 with omega-6, there may be little to no difference in serious adverse events (RR 1.12, 95% CI 0.38 to 3.31; 4 studies, 230 participants; 6% in omega-3 versus 5% in omega-6 group; low-certainty evidence). In four trials examining antioxidant supplementation with placebo, there may be little to no difference in relapses (RR 0.98, 95% CI 0.59 to 1.64; 4 studies, 345 participants; 17% in the antioxidant group versus 17% in the placebo group; low-certainty evidence). In six trials examining antioxidant supplementation with placebo, the evidence was very uncertain concerning change in disability progression, measured as mean change of EDSS (MD -0.19, 95% CI -0.49 to 0.11; 6 studies, 490 participants; very low-certainty evidence). In two trials examining antioxidant supplementation with placebo, there may be little to no difference in global impression of deterioration (RR 0.99, 95% 0.50 to 1.93; 2 studies, 190 participants; 15% in the antioxidant group versus 15% in the placebo group; low-certainty evidence). In two trials examining antioxidant supplementation with placebo, the evidence was very uncertain concerning difference in gadolinium-enhancing lesions (RR 0.67, 95% CI 0.09 to 4.88; 2 studies, 131 participants; 11% in the antioxidant group versus 16% in the placebo group; very low-certainty evidence). In three trials examining antioxidant supplementation versus placebo, there may be little to no difference in serious adverse events (RR. 0.72, 95% CI 0.17 to 3.08; 3 studies, 222 participants; 3% in the antioxidant group versus 4% in the placebo group; low-certainty evidence).
AUTHORS' CONCLUSIONS
There are a variety of controlled trials addressing the effects of dietary interventions for MS with substantial variation in active treatment, comparator, and outcomes of interest. PUFA administration may not differ when compared to alternatives with regards to relapse rate, disability worsening, or overall clinical status in people with MS, but evidence is uncertain. Similarly, at present, there is insufficient evidence to determine whether supplementation with antioxidants or other dietary interventions have any impact on MS-related outcomes.",2020,"PUFA administration may not differ when compared to alternatives with regards to relapse rate, disability worsening, or overall clinical status in people with MS, but evidence is uncertain.","['people with MS', 'Participants were adults with MS, defined by established criteria, presenting to MS clinics in Europe, North America, and the Middle East']","['PUFAs with monounsaturated fatty acids (MUFAs', 'antioxidant supplements (10 trials); dietary programmes (3 trials); and other dietary supplements (e.g. acetyl L-carnitine, biotin, creatine, palmitoylethanolamide, probiotic, riboflavin', 'supplementation to increase polyunsaturated fatty acids (PUFAs', 'dietary interventions', 'dietary intervention versus placebo', 'PUFA', 'PUFAs with MUFAs', 'omega-3 with omega-6', 'PUFAs (omega-3 versus omega-6', 'placebo']","['relapses, disability progression, and magnetic resonance imaging (MRI) measures', 'Expanded Disability Status Scale (EDSS) (mean difference (MD', 'global impression of deterioration', 'disability progression', 'serious adverse events', 'number of participants experiencing relapse and change in disability progression, according to a validated disability scale', 'health outcomes', 'relapses (risk ratio (RR', 'MRI activity, safety, and patient-reported outcomes', 'gadolinium-enhancing lesions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3839267', 'cui_str': 'Multiple sclerosis clinic'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1719844', 'cui_str': 'Omega'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",86.0,0.466002,"PUFA administration may not differ when compared to alternatives with regards to relapse rate, disability worsening, or overall clinical status in people with MS, but evidence is uncertain.","[{'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Parks', 'Affiliation': 'Department of Medicine, Division of Neurology, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Caitlin S', 'Initials': 'CS', 'LastName': 'Jackson-Tarlton', 'Affiliation': 'Department of Medicine, Division of Neurology, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vacchi', 'Affiliation': 'Department of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Roah', 'Initials': 'R', 'LastName': 'Merdad', 'Affiliation': 'Department of Community Health and Epidemiology, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Bradley C', 'Initials': 'BC', 'LastName': 'Johnston', 'Affiliation': 'Department of Nutrition, Texas A&M University, College Station, Texas, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004192.pub4']
2371,32434370,Comparison of the effects of general and local anesthesia in lumbar interlaminar endoscopic surgery.,"BACKGROUND
Percutaneous endoscopic lumbar discectomy (PELD) with an interlaminar approach is a technique used to treat lumbar disc hernia. It has not yet been established whether general or local anesthesia (LA) is preferable for lumbar interlaminar endoscopic surgery.
METHODS
Between October, 2012 and June, 2016, 60 patients were recruited and randomly divided into 2 groups: the general anesthesia (GA) group and the LA group. The patients' basic clinical data, intraoperative patient experience, Oswestry disability index (ODI), visual analog scale (VAS) score, and the postoperative patient satisfaction rate were assessed.
RESULTS
Statistically significant differences were found between the two groups in operative time and length of hospital stay. There were no significant differences in postoperative ODI or VAS scores between the two groups during follow-up at 3, 6, and 12 months. One patient in the GA group sustained a nerve root injury intraoperatively. Two patients in the LA group suffered adverse reactions, as did six patients in the GA group. However, 50% of the patients expressed fear about undergoing the surgery with LA, while all patients felt they could undergo the same surgery with GA.
CONCLUSIONS
General and LA are both suitable for use in lumbar interlaminar endoscopic surgery. However, GA makes a positive intraoperative surgical experience more likely for the patient.",2020,"There were no significant differences in postoperative ODI or VAS scores between the two groups during follow-up at 3, 6, and 12 months.","['lumbar interlaminar endoscopic surgery', 'Between October, 2012 and June, 2016', '60 patients', 'lumbar disc hernia']","['GA', 'local anesthesia (LA', 'Percutaneous endoscopic lumbar discectomy (PELD', 'general anesthesia (GA) group and the LA', 'LA', 'general and local anesthesia']","['intraoperative patient experience, Oswestry disability index (ODI), visual analog scale (VAS) score, and the postoperative patient satisfaction rate', 'adverse reactions', 'operative time and length of hospital stay', 'postoperative ODI or VAS scores']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.0380796,"There were no significant differences in postoperative ODI or VAS scores between the two groups during follow-up at 3, 6, and 12 months.","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Ye', 'Affiliation': ""Department of Anesthesiology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Ai-Min', 'Initials': 'AM', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Lin-Zheng', 'Initials': 'LZ', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Jiao-Xiang', 'Initials': 'JX', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Sun-Ren', 'Initials': 'SR', 'LastName': 'Sheng', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China. shengsunren82330@126.com.""}]",Annals of palliative medicine,['10.21037/apm-20-623']
2372,32434761,A School-Based Intervention for Mental Illness Stigma: A Cluster Randomized Trial.,"OBJECTIVES
To determine the effectiveness of a school-based curriculum, Eliminating the Stigma of Differences (ESD), in improving attitudinal and/or behavioral contexts regarding mental illness in schools and increasing the likelihood that youth seek treatment for mental health problems when needed.
METHODS
We conducted a cluster randomized trial in sixth-grade classes from 14 schools in 2011 and 2012 with follow-up at 6-month intervals through 24 months (2012-2015). Using a fully crossed 2 × 2 × 2 factorial design, we compared ESD to a no-intervention control and to 2 comparator interventions: (1) contact with 2 young adults with a history of mental illness and (2) exposure to antistigma printed materials. We implemented interventions in classrooms in an ethnically and socioeconomically diverse school district. There were 416 youth who participated in the follow-up, and 312 (75%) of these participated for the full 2 years. Outcome measures were knowledge and positive attitudes, social distance from peers with mental illness, and mental health treatment seeking.
RESULTS
Youth assigned to ESD reported greater knowledge and positive attitudes and reduced social distance (Cohen's d = 0.35 and 0.16, respectively) than youth in the comparator interventions and no-intervention groups across the 2-year follow-up. Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention.
CONCLUSIONS
ESD shows potential for improving the social climate related to mental illnesses in schools and increasing treatment seeking when needed. ESD and interventions like it show promise as part of a public mental health response to youth with mental health needs in schools.",2020,"Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention.
","['416 youth who participated in the follow-up, and 312 (75%) of these participated for the full 2 years', 'sixth-grade classes from 14 schools in 2011 and 2012 with follow-up at 6-month intervals through 24 months (2012-2015', 'classrooms in an ethnically and socioeconomically diverse school district', 'Mental Illness Stigma']",['ESD to a no-intervention control and to 2 comparator interventions: (1) contact with 2 young adults with a history of mental illness and (2) exposure to antistigma printed materials'],"['mental health symptoms', 'knowledge and positive attitudes, social distance from peers with mental illness, and mental health treatment seeking', 'knowledge and positive attitudes and reduced social distance']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]",2.0,0.0591902,"Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention.
","[{'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Link', 'Affiliation': 'Department of Sociology, School of Public Policy, University of California, Riverside, Riverside, California; bruce.link@ucr.edu.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'DuPont-Reyes', 'Affiliation': 'Latino Research Institute, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Barkin', 'Affiliation': 'Mental Health Connection of Tarrant County, Fort Worth, Texas.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Villatoro', 'Affiliation': 'Latino Research Institute, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Jo C', 'Initials': 'JC', 'LastName': 'Phelan', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York; and.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Painter', 'Affiliation': 'School of Social Work, University of Texas Arlington, Arlington, Texas.'}]",Pediatrics,['10.1542/peds.2019-0780']
2373,32434362,The clinical effect of plum blossom needle acupuncture with qi-invigorating superficies-consolidating therapy on seborrheic alopecia.,"BACKGROUND
Seborrheic alopecia (SA) is a common dermatological disease with a long disease course, and treatment for this disease usually exhibits slow effects. Currently, Western medicine treatments have shown some effects; however, they also have certain limitations. In recent years, Chinese medicine has made breakthroughs in treating SA. The efficacy of plum blossom needle acupuncture with qi-invigorating superficies-consolidating therapy for SA was observed, and its clinical effects were investigated in this study.
METHODS
A total of 87 patients with SA treated at the First Affiliated Hospital of Guangzhou University of Chinese Medicine from September 2018 to September 2019 were enrolled as the research subjects. They were divided into a Western medicine group and a Chinese medicine group by the random number table method. The 43 patients in the Western medicine group were treated with conventional Western medicine, and the 44 patients in the Chinese medicine group were treated with a comprehensive traditional Chinese medicine regimen of plum blossom needling with qi-invigorating superficies-consolidating therapy. The treatment effects, changes in estradiol (E2) and testosterone (T) levels, and scores for various body signs (hair growth and hair loss) of the two groups before and after treatment were compared.
RESULTS
The difference in total effective rate between the Chinese medicine group and the Western medicine group (95.45% vs. 81.40%) was statistically significant (P<0.05). After treatment, the T levels of both groups were lower than before treatment, and the E2 levels of both groups were higher than before treatment; the difference between the two groups was statistically significant (P<0.05). After treatment, the hair growth and hair loss scores of the two groups were lower than those before treatment, and those of the Chinese medicine group were lower than those of the Western medicine group; the differences were statistically significant (P<0.05).
CONCLUSIONS
Plum blossom needle acupuncture combined with qi-invigorating superficies-consolidating therapy is significantly effective for treating patients with SA. It can effectively adjust the patient's hormone levels, improve hair loss, and promote hair growth. It has the advantages of simplicity, tolerability, and low cost. It cures the cause of the disease and is worth promoting.",2020,"After treatment, the T levels of both groups were lower than before treatment, and the E2 levels of both groups were higher than before treatment; the difference between the two groups was statistically significant (P<0.05).","['87 patients with SA treated at the First Affiliated Hospital of Guangzhou University of Chinese Medicine from September 2018 to September 2019 were enrolled as the research subjects', 'patients with SA', '43 patients in the Western medicine group were treated with']","['conventional Western medicine', 'plum blossom needle acupuncture with qi-invigorating superficies-consolidating therapy', 'Chinese medicine', 'comprehensive traditional Chinese medicine regimen of plum blossom needling with qi-invigorating superficies-consolidating therapy']","['hair growth and hair loss scores', 'total effective rate', 'seborrheic alopecia', 'changes in estradiol (E2) and testosterone (T) levels, and scores for various body signs (hair growth and hair loss', 'E2 levels', 'T levels', 'hair loss, and promote hair growth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0232407', 'cui_str': 'Hair growth'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",87.0,0.0221398,"After treatment, the T levels of both groups were lower than before treatment, and the E2 levels of both groups were higher than before treatment; the difference between the two groups was statistically significant (P<0.05).","[{'ForeName': 'Qiuyi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Yubin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Xushan', 'Initials': 'X', 'LastName': 'Zha', 'Affiliation': 'Department of Dermatology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China. lmmengmeng@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-909']
2374,32434359,Effectiveness of different silicone oil remove methods after vitrectomy and light silicone oil tamponade in elderly patients.,"BACKGROUND
During the remove of oil from the silicone oil-filled eye after vitrectomy, perfusion fluid is often mistakenly aspirated when mechanical force is used to remove the oil. This leads to a sudden sharp drop in intraocular pressure and collapse of the eyeball, which may cause complications. The aspiration of perfusion fluid can be detected when the oil is removed manually, and the force of the hand and location of the aspiration can be adjusted to remove the silicone oil instead. In this study, we assessed the efficacy and safety of a manual 23-gauge (23G) silicone oil remove method and confirmed that this is a feasible, highly efficient, safe, simple and economical way to remove oil.
METHODS
We recruited 130 patients (130 affected eyes) 3-6 months after they had undergone vitrectomy and light silicone oil tamponade at our hospital. The patients/eyes were randomly divided into two groups (manual or vitrectomy system), with 65 eyes in each group. All eyes in both groups underwent 23G oil remove by the same physician. The following aspects of the two groups were compared: 1. Oil remove duration; 2. Average intraocular pressure at 1 day, 1 week and 1 month after the procedure; and 3. Postoperative complications, such as retinal redetachment, silicone oil residue, massive suprachoroidal hemorrhage and choroid detachment.
RESULTS
The average oil remove durations of the manual group and the vitrectomy system group were 5.92±1.34 and 8.87±1.68 min, respectively (P<0.05); the duration for the manual group was significantly shorter than that for the vitrectomy system group (t=11.07, P=0). The average intraocular pressures at 1 day, 1 week and 1 month after operation of the manual group were 10.2±2.7, 15.2±3.5 and 17.2±3.1 mmHg, respectively, and those of the vitrectomy system group were 9.8±2.4, 15.5±3.1 and 16.8±3.4 mmHg, respectively; the differences between the two groups were not statistically significant at any time point (t=0.892, P=0.374 at 1 day; t=0.517, P=0.606 at 1 week; and t=0.701, P=0.485 at 1 month). The difference in the incidence of postoperative complications, including retinal redetachment, silicone oil residue, massive suprachoroidal hemorrhage and choroid detachment, between the two groups was statistically significant (χ 2 =4.2787, P=0.0386). None of the affected eyes were complicated with transient intraocular hypotension, vitreous hemorrhage or endophthalmitis.
CONCLUSIONS
The manual 23G silicone oil remove method is highly efficient, safe, simple and economical and can be used conveniently and clinically by the majority of medical institutions.",2020,"The manual 23G silicone oil remove method is highly efficient, safe, simple and economical and can be used conveniently and clinically by the majority of medical institutions.","['130 patients (130 affected eyes) 3-6 months after they had undergone vitrectomy and light silicone oil tamponade at our hospital', 'elderly patients']","['silicone oil remove methods after vitrectomy and light silicone oil tamponade', 'manual 23-gauge (23G) silicone oil']","['Average intraocular pressure', 'average intraocular pressures', 'Postoperative complications, such as retinal redetachment, silicone oil residue, massive suprachoroidal hemorrhage and choroid detachment', 'efficacy and safety', 'transient intraocular hypotension, vitreous hemorrhage or endophthalmitis', 'incidence of postoperative complications, including retinal redetachment, silicone oil residue, massive suprachoroidal hemorrhage and choroid detachment', 'average oil remove durations']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C1644185', 'cui_str': 'Suprachoroidal hemorrhage'}, {'cui': 'C0008520', 'cui_str': 'Choroidal structure'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0014236', 'cui_str': 'Endophthalmitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",130.0,0.0259711,"The manual 23G silicone oil remove method is highly efficient, safe, simple and economical and can be used conveniently and clinically by the majority of medical institutions.","[{'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': ""Department of Ophthalmology, Liuzhou People's Hospital, Liuzhou 545006, China. wanxiaobo_gx@163.com.""}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou 545006, China.'}, {'ForeName': 'Qiguang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou 545006, China.'}]",Annals of palliative medicine,['10.21037/apm-20-949']
2375,32434996,Monounsaturated fat rapidly induces hepatic gluconeogenesis and whole-body insulin resistance.,"BACKGROUNDWhile saturated fat intake leads to insulin resistance and nonalcoholic fatty liver, Mediterranean-like diets enriched in monounsaturated fatty acids (MUFA) may have beneficial effects. This study examined effects of MUFA on tissue-specific insulin sensitivity and energy metabolism.METHODSA randomized placebo-controlled cross-over study enrolled 16 glucose-tolerant volunteers to receive either oil (OIL, ~1.18 g/kg), rich in MUFA, or vehicle (VCL, water) on 2 occasions. Insulin sensitivity was assessed during preclamp and hyperinsulinemic-euglycemic clamp conditions. Ingestion of 2H2O/acetaminophen was combined with [6,6-2H2]glucose infusion and in vivo 13C/31P/1H/ex vivo 2H-magnet resonance spectroscopy to quantify hepatic glucose and energy fluxes.RESULTSOIL increased plasma triglycerides and oleic acid concentrations by 44% and 66% compared with VCL. Upon OIL intervention, preclamp hepatic and whole-body insulin sensitivity markedly decreased by 28% and 27%, respectively, along with 61% higher rates of hepatic gluconeogenesis and 32% lower rates of net glycogenolysis, while hepatic triglyceride and ATP concentrations did not differ from VCL. During insulin stimulation hepatic and whole-body insulin sensitivity were reduced by 21% and 25%, respectively, after OIL ingestion compared with that in controls.CONCLUSIONA single MUFA-load suffices to induce insulin resistance but affects neither hepatic triglycerides nor energy-rich phosphates. These data indicate that amount of ingested fat, rather than its composition, primarily determines the development of acute insulin resistance.TRIAL REGISTRATIONClinicalTrials.gov NCT01736202.FUNDINGGerman Diabetes Center, German Federal Ministry of Health, Ministry of Culture and Science of the state of North Rhine-Westphalia, German Federal Ministry of Education and Research, German Diabetes Association, German Center for Diabetes Research, Portugal Foundation for Science and Technology, European Regional Development Fund, and Rede Nacional de Ressonancia Magnética Nuclear.",2020,"During insulin stimulation hepatic and whole-body insulin sensitivity were reduced by 21% and 25%, respectively, after OIL ingestion compared with that in controls.",['controlled cross-over study enrolled 16 glucose-tolerant volunteers'],"['2H2O/acetaminophen', 'oil (OIL, ~1.18 g/kg), rich in MUFA, or vehicle (VCL, water', 'MUFA', 'placebo']","['insulin stimulation hepatic and whole-body insulin sensitivity', 'hepatic glucose and energy fluxes', 'tissue-specific insulin sensitivity and energy metabolism', 'hepatic gluconeogenesis and whole-body insulin resistance', 'hepatic gluconeogenesis', 'preclamp hepatic and whole-body insulin sensitivity', 'Insulin sensitivity', 'plasma triglycerides and oleic acid concentrations', 'rates of net glycogenolysis, while hepatic triglyceride and ATP concentrations']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C1454484', 'cui_str': 'VCL protein, human'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0017715', 'cui_str': 'Gluconeogenesis'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0596624', 'cui_str': 'Glycogenolysis'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}]",,0.110362,"During insulin stimulation hepatic and whole-body insulin sensitivity were reduced by 21% and 25%, respectively, after OIL ingestion compared with that in controls.","[{'ForeName': 'Theresia', 'Initials': 'T', 'LastName': 'Sarabhai', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kahl', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Szendroedi', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Markgraf', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Oana-Patricia', 'Initials': 'OP', 'LastName': 'Zaharia', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Barosa', 'Affiliation': 'Centre for Neurosciences and Cell Biology, UC Biotech, Cantanhede, Portugal.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herder', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Frithjof', 'Initials': 'F', 'LastName': 'Wickrath', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Bobrov', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Jong-Hee', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'John Griffith', 'Initials': 'JG', 'LastName': 'Jones', 'Affiliation': 'Centre for Neurosciences and Cell Biology, UC Biotech, Cantanhede, Portugal.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}]",JCI insight,['10.1172/jci.insight.134520']
2376,32434932,Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach.,"OBJECTIVES
To evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence.
DESIGN
Repeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial.
SETTING
Research clinic in Kigali, Rwanda.
PARTICIPANTS
Rwandan women with high sexual risk.
INTERVENTIONS
Women diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet.
OUTCOME MEASURES
Adherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131).
RESULTS
Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher's exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients.
CONCLUSIONS
High-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes.
TRIAL REGISTRATION NUMBER
NCT02459665.",2020,"Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence.","['Research clinic in Kigali, Rwanda', 'randomised women and women attending recruitment sessions (n=131', 'Rwandan women with high sexual risk participating', 'Rwandan women with high sexual risk', 'Women diagnosed with BV and/or trichomoniasis', 'Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics']","['EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet', 'intermittent vaginal probiotic or antibiotic', 'metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi']","['Self-reported vaginal washing practices', 'Vaginal probiotic adherence and acceptability', 'Vaginal infection knowledge', 'sexual risk behaviours', 'Adherence and acceptability', 'BV recurrence', 'Vaginal probiotic acceptability and adherence', 'reporting urogenital symptoms']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0040921', 'cui_str': 'Infection by Trichomonas'}, {'cui': 'C0240816', 'cui_str': 'Sex worker'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C1273011', 'cui_str': 'Vaginal capsule'}, {'cui': 'C0042264', 'cui_str': 'Vaginal tablet'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0360345', 'cui_str': 'Metronidazole-containing product in oral dose form'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0404521', 'cui_str': 'Infective vaginitis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.22675,"Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence.","[{'ForeName': 'Marijn C', 'Initials': 'MC', 'LastName': 'Verwijs', 'Affiliation': 'Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, Merseyside, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Agaba', 'Affiliation': 'Rinda Ubuzima, Kigali, Rwanda.'}, {'ForeName': 'Marie Michele', 'Initials': 'MM', 'LastName': 'Umulisa', 'Affiliation': 'Rinda Ubuzima, Kigali, Rwanda.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Uwineza', 'Affiliation': 'Rinda Ubuzima, Kigali, Rwanda.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Nivoliez', 'Affiliation': 'Biose, Aurillac, France.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Lievens', 'Affiliation': 'Winclove, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke H H M', 'Initials': 'JHHM', 'LastName': 'van de Wijgert', 'Affiliation': 'Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, Merseyside, UK j.vandewijgert@liverpool.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-031819']
2377,17212883,A warm-up laparoscopic exercise improves the subsequent laparoscopic performance of Ob-Gyn residents: a low-cost laparoscopic trainer.,"INTRODUCTION
Residents traditionally acquire surgical skills through on-the-job training. Minimally invasive laparoscopic techniques present additional demands to master complex surgical procedures in a remote 2-dimensional venue. We examined the effectiveness of a brief warm-up laparoscopic simulation toward improving operative proficiency.
METHODS
Using a ""Poor-Man's Laparoscopy Simulator,"" 12 Ob/Gyn residents and 12 medical students were allocated 10 minutes to transfer 30 tablets with a 5-mm grasper from point A to point B via laparoscopic visualization in a warm-up exercise. Participants repeated the exercise following a 5-minute pause. Mean scores, expressed in seconds/tablet, and overall improvement (percentage difference between warm-up and follow-up) were analyzed according to postgraduate standing (PGY14), dexterity skills, and pertinent vocational activities.
RESULTS
Significant improvements were noted for both residents (+25%) and medical students (+29%), P<0.0001. Scores between the 2 groups, however, were not significant (P=0.677). Proficiency was not influenced by PGY standing. Interestingly, the best (8.73 sec/pill) and the worst (25 sec/pill) scores were attained by a medical student and a chief resident, respectively, suggesting the contribution of individual aptitude.
CONCLUSION
A brief warm-up exercise before an actual laparoscopic surgical procedure significantly improves subsequent laparoscopic performance.",2006,"RESULTS
Significant improvements were noted for both residents (+25%) and medical students (+29%), P<0.0001.","[' 12 Ob/Gyn residents and 12 medical students', 'Ob-Gyn residents']","['A warm-up laparoscopic exercise', 'transfer 30 tablets with a 5-mm grasper from point A to point B via laparoscopic visualization in a warm-up exercise', ""Poor-Man's Laparoscopy Simulator"", 'brief warm-up laparoscopic simulation']","['subsequent laparoscopic performance', 'postgraduate standing (PGY14), dexterity skills, and pertinent vocational activities', 'Mean scores, expressed in seconds/tablet, and overall improvement']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C2924613', 'cui_str': 'Point B'}, {'cui': 'C2350169', 'cui_str': 'Warmup Exercise'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0578393', 'cui_str': 'Occupation and employment activity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0326275,"RESULTS
Significant improvements were noted for both residents (+25%) and medical students (+29%), P<0.0001.","[{'ForeName': 'Ann T', 'Initials': 'AT', 'LastName': 'Do', 'Affiliation': 'Department of Obstetrics and Gynecology, The Brooklyn Hospital Center, Brooklyn, New York 11209, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Cabbad', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kerr', 'Affiliation': ''}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Serur', 'Affiliation': ''}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Robertazzi', 'Affiliation': ''}, {'ForeName': 'Miljan R', 'Initials': 'MR', 'LastName': 'Stankovic', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2378,17212893,Infiltration of suture sites with local anesthesia for management of pain following laparoscopic ventral hernia repairs: a prospective randomized trial.,"BACKGROUND
Postoperative pain control after laparoscopic ventral hernia repairs remains a significant clinical problem. We sought to determine the pain-sparing efficacy of local anesthetic infiltrated into the abdominal wall wounds created by the placement of transabdominal sutures used to ensure adequate fixation of the mesh during laparoscopic ventral hernia repair.
METHODS
Patients undergoing laparoscopic ventral/incisional hernia repair were randomized to receive local anesthesia (0.25% bupivacaine with epinephrine) into all layers of the abdominal wall to the level of the parietal peritoneum at suture fixation sites immediately before suture placement (Group I; n=9) or no local anesthesia (Group II, control; n=9). The anesthetic technique was otherwise standard for both groups. Postoperatively, pain was assessed with a 10-point visual analogue scale (VAS) at 1, 2, 4, and 24 hours. Analgesic use and hospital stay were also recorded.
RESULTS
The groups were similar in age, sex, ASA, and size of hernia defect. The operative times were not statistically different between the 2 groups (Group I, 118+/-12 minutes; Group II, 144+/-21 minutes; P>0.05). Group I had a statistically significant decrease in the pain scores compared with Group II (2.2+/-0.8 vs. 6.4+/-0.9; P<0.05) at 1 hour postoperatively. At 2 and 4 hours, the mean pain scores were decreased but not statistically different. Similarly, the cumulative consumption of pain medication at 1, 2, and 4 hours postoperatively as well as the average hospital stay (Group I, 2.0+/-0.4; Group II, 2.4+/-0.4 days) were lower but not statistically significant in patients in Group I compared with those in Group II.
CONCLUSION
This small, randomized study demonstrates that infiltration of suture fixation sites is effective in reducing early postoperative pain but not analgesic consumption following laparoscopic incisional and ventral hernia repairs. A larger study is required to investigate this strategy on later postoperative pain and hospital stay.",2006,Group I had a statistically significant decrease in the pain scores compared with Group II (2.2+/-0.8 vs. 6.4+/-0.9; P<0.05) at 1 hour postoperatively.,"['laparoscopic incisional and ventral hernia repairs', 'pain following laparoscopic ventral hernia repairs', 'Patients undergoing laparoscopic ventral/incisional hernia repair']","['transabdominal sutures', 'local anesthesia (0.25% bupivacaine with epinephrine) into all layers of the abdominal wall to the level of the parietal peritoneum at suture fixation sites immediately before suture placement (Group I; n=9) or no local anesthesia', 'suture fixation sites', 'local anesthesia']","['operative times', 'cumulative consumption of pain medication', '10-point visual analogue scale (VAS', 'Analgesic use and hospital stay', 'pain-sparing efficacy', 'pain scores', 'mean pain scores', 'average hospital stay']","[{'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0342971', 'cui_str': 'Repair of incisional hernia (procedure)'}]","[{'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0230203', 'cui_str': 'Parietal peritoneum structure'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0486604,Group I had a statistically significant decrease in the pain scores compared with Group II (2.2+/-0.8 vs. 6.4+/-0.9; P<0.05) at 1 hour postoperatively.,"[{'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Bellows', 'Affiliation': 'Department of Surgery, Baylor College of Medicine, Michael E, DeBakey VA Medical Center, Houston, Texas 77030, USA. cbellows@bcm.tmc.edu'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Berger', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2379,17212895,Factors leading to long-term hospitalization after laparoscopic appendectomy.,"BACKGROUND
Randomized studies demonstrate that laparoscopic appendectomy yields better results compared with open techniques. We sought to identify factors that determine an extended hospital stay among patients undergoing laparoscopic appendectomy.
METHODS
This was a prospective study including 669 patients undergoing laparoscopic appendectomy. We analyzed variables that can predict the length of hospital stay.
RESULTS
Of 669 patients undergoing laparoscopic appendectomy, 141 stayed in the hospital for > or = 5 days (Group 1), and 97 stayed in the hospital for < or = 1 day after surgery (Group 2). The univariate analysis demonstrated that fever (P<0.0001), nausea and vomiting (P=0.060), leukocytosis (P<0.0001), gangrened or perforated intraoperative appearance of the appendix (P<0.0001), and appendix position behind the ileocecal junction (P<0.001) were related to a longer hospital stay. The multivariate analysis through logistical regression showed that the factors independently and significantly associated with an extended hospital stay were presurgical fever, appendix position behind the ileocecal junction, and intraoperative gangrened or perforated appearance of the appendix.
CONCLUSION
Fever, appearance, and position of the appendix are factors related to an extended hospital stay.",2006,"The univariate analysis demonstrated that fever (P<0.0001), nausea and vomiting (P=0.060), leukocytosis (P<0.0001), gangrened or perforated intraoperative appearance of the appendix (P<0.0001), and appendix position behind the ileocecal junction (P<0.001) were related to a longer hospital stay.","['669 patients undergoing laparoscopic appendectomy, 141 stayed in the hospital for > or = 5 days (Group 1), and 97 stayed in the hospital for < or = 1 day after surgery (Group 2', '669 patients undergoing', 'patients undergoing laparoscopic appendectomy']",['laparoscopic appendectomy'],"['length of hospital stay', 'leukocytosis', 'nausea and vomiting', 'fever']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",669.0,0.0547395,"The univariate analysis demonstrated that fever (P<0.0001), nausea and vomiting (P=0.060), leukocytosis (P<0.0001), gangrened or perforated intraoperative appearance of the appendix (P<0.0001), and appendix position behind the ileocecal junction (P<0.001) were related to a longer hospital stay.","[{'ForeName': 'Paulo Cezar Galvão', 'Initials': 'PC', 'LastName': 'do Amaral', 'Affiliation': 'General Surgery Division, São Rafael Hospital, Department of Surgery, Escola Bahiana de Medicina e Saúde Pública, Salvador, Bahia, Brazil. pcgamaral@terra.com.br'}, {'ForeName': 'Euler de Medeiros Azaro', 'Initials': 'Ede M', 'LastName': 'Filho', 'Affiliation': ''}, {'ForeName': 'Thales Delmondes', 'Initials': 'TD', 'LastName': 'Galvão', 'Affiliation': ''}, {'ForeName': 'Eric Ettinger', 'Initials': 'EE', 'LastName': 'Junior', 'Affiliation': ''}, {'ForeName': 'Galeno Egydio José', 'Initials': 'GE', 'LastName': 'de Magalhães Neto', 'Affiliation': ''}, {'ForeName': 'Fabrício', 'Initials': 'F', 'LastName': 'Mascarenhas', 'Affiliation': ''}, {'ForeName': 'Edvaldo', 'Initials': 'E', 'LastName': 'Fahel', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2380,31515355,"Health-related quality of life in transplant ineligible newly diagnosed multiple myeloma patients treated with either thalidomide or lenalidomide-based regimen until progression: a prospective, open-label, multicenter, randomized, phase 3 study.","Data on the impact of long term treatment with immunomodulatory drugs (IMiD) on health-related quality of life (HRQoL) is limited. The HOVON-87/NMSG18 study was a randomized, phase 3 study in newly diagnosed transplant ineligible patients with multiple myeloma, comparing melphalan-prednisolone in combination with thalidomide or lenalidomide, followed by maintenance therapy until progression (MPT-T or MPR-R). The EORTC QLQ-C30 and MY20 questionnaires were completed at baseline, after three and nine induction cycles and six and 12 months of maintenance therapy. Linear mixed models and minimal important differences were used for evaluation. 596 patients participated in HRQoL reporting. Patients reported clinically relevant improvement in global quality of life (QoL), future perspective and role and emotional functioning, and less fatigue and pain in both arms. The latter being of large effect size. In general, improvement occurred after 6-12 months of maintenance only and was independent of the World Health Organisation performance at baseline. Patients treated with MPR-R reported clinically relevant worsening of diarrhea, and patients treated with MPT-T reported a higher incidence of neuropathy. Patients who remained on lenalidomide maintenance therapy for at least three months reported clinically meaningful improvement in global QoL and role functioning at six months, remaining stable thereafter. There were no clinically meaningful deteriorations, but patients on thalidomide reported clinically relevant worsening in neuropathy. In general, HRQoL improves both during induction and maintenance therapy with immunomodulatory drugs. The side effect profile of treatment did not negatively affect global QoL, but it was, however, clinically relevant for the patients. ( Clinicaltrials.gov identifier: NTR1630 ).",2020,"Patients reported clinically relevant improvement in global quality of life, future perspective and role and emotional functioning, and less fatigue and pain in both arms.","['596 patients participated in health-related quality of life reporting', 'newly diagnosed transplant ineligible patients with multiple myeloma, comparing', 'transplant ineligible newly diagnosed multiple myeloma patients treated with either']","['melphalan-prednisolone in combination with thalidomide or lenalidomide, followed by maintenance therapy until progression (MPT-T or MPR-R', 'thalidomide or lenalidomide', 'thalidomide']","['global quality of life', 'global QoL and role functioning', 'global quality of life, future perspective and role and emotional functioning, and less fatigue and pain', 'neuropathy', 'diarrhea', 'Health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",596.0,0.0684156,"Patients reported clinically relevant improvement in global quality of life, future perspective and role and emotional functioning, and less fatigue and pain in both arms.","[{'ForeName': 'Lene Kongsgaard', 'Initials': 'LK', 'LastName': 'Nielsen', 'Affiliation': 'Quality of Life Research Center, Department of Haematology, Odense University Hospital, Odense, Denmark lene.kongsgaard.nielsen@rsyd.dk.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Stege', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Hematology, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam, the Netherlands.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Section of Hematology and Coagulation, Department of Medicine, Sahlgrenska University Hospital, Gotheborg, Sweden.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Salomo', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Department of Haematology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Visser-Wisselaar', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hansson', 'Affiliation': 'Department of Haematology and Wallenberg Center for Molecular Medicine, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Velden', 'Affiliation': 'Department of Internal Medicine, Martini Ziekenhuis, Groningen, the Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Deenik', 'Affiliation': 'Department of Internal Medicine, Tergooi Ziekenhuis, Hilversum, the Netherlands.'}, {'ForeName': 'Juleon', 'Initials': 'J', 'LastName': 'Coenen', 'Affiliation': 'Department of Internal Medicine, Isala, Zwolle, the Netherlands.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Hinge', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, Vejle Hospital, Vejle, Denmark.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Department of Internal Medicine, Meander Medisch Centrum, Amersfoort, the Netherlands.'}, {'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Tanis', 'Affiliation': 'Department of Internal Medicine, Groene Hart Ziekenhuis, Gouda, the Netherlands.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Szatkowski', 'Affiliation': 'Department of Oncology, Haematology and Palliative Care, Førde Central Hospital, Førde, Norway.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Brouwer', 'Affiliation': 'Department of Internal Medicine, Reinier de Graaf Ziekenhuis, Delft, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Westerman', 'Affiliation': 'Department of Internal Medicine, Northwest Clinics, Alkmaar, the Netherlands.'}, {'ForeName': 'Rineke', 'Initials': 'R', 'LastName': 'Leys', 'Affiliation': 'Department of Internal Medicine, Maasstad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'Sinnige', 'Affiliation': 'Department of Internal Medicine, Jeroen Bosch Ziekenhuis, Den Bosch, the Netherlands.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Haukås', 'Affiliation': 'Department of Haematology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'van der Hem', 'Affiliation': 'Department of Internal Medicine, Zaans Medisch Centrum, Zaandam, the Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Durian', 'Affiliation': 'Department of Internal Medicine, Tweesteden Ziekenhuis, Tilburg, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gimsing', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van de Donk', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Hematology, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Haematology, Erasmus Medical Center Cancer Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'Department of Haematology, St Olavs Hospital and Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Abildgaard', 'Affiliation': 'Quality of Life Research Center, Department of Haematology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Hematology, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}]",Haematologica,['10.3324/haematol.2019.222299']
2381,31421157,Impact of combined selective internal radiation therapy and sorafenib on survival in advanced hepatocellular carcinoma.,"BACKGROUND & AIMS
Sorafenib is the recommended treatment for patients with advanced hepatocellular carcinoma (HCC). We aimed to compare the efficacy and safety of a combination of sorafenib and selective internal radiation therapy (SIRT) - with yttrium-90 ( 90 Y) resin microspheres - to sorafenib alone in patients with advanced HCC.
METHODS
SORAMIC is a randomised controlled trial comprising diagnostic, local ablation and palliative cohorts. Based on diagnostic study results, patients were assigned to local ablation or palliative cohorts. In the palliative cohort, patients not eligible for TACE were randomised 11:10 to SIRT plus sorafenib (SIRT + sorafenib) or sorafenib alone. The primary endpoint was overall survival (OS; Kaplan-Meier analysis) in the intention-to-treat (ITT) population.
RESULTS
In the ITT cohort, 216 patients were randomised to SIRT + sorafenib and 208 to sorafenib alone. Median OS was 12.1 months in the SIRT + sorafenib arm, and 11.4 months in the sorafenib arm (hazard ratio [HR] 1.01; 95% CI 0.81-1.25; p = 0.9529). Median OS in the per protocol population was 14.0 months in the SIRT + sorafenib arm (n = 114), and 11.1 months in the sorafenib arm (n = 174; HR 0.86; p = 0.2515). Subgroup analyses of the per protocol population indicated a survival benefit of SIRT + sorafenib for patients without cirrhosis (HR 0.46; 0.25-0.86; p = 0.02); cirrhosis of non-alcoholic aetiology (HR 0.63; p = 0.012); or patients ≤65 years old (HR 0.65; p = 0.05). Adverse events (AEs) of Common Terminology Criteria for AE Grades 3-4 were reported in 103/159 (64.8%) patients who received SIRT + sorafenib, 106/197 (53.8%) patients who received sorafenib alone (p = 0.04), and 8/24 (33.3%) patients who only received SIRT.
CONCLUSION
Addition of SIRT to sorafenib did not result in a significant improvement in OS compared with sorafenib alone. Subgroup analyses led to hypothesis-generating results that will support the design of future studies.
LAY SUMMARY
Sorafenib given orally is the recommended treatment for patients with advanced hepatocellular carcinoma (HCC). In selective internal radiation therapy (SIRT), also known as radioembolisation, microscopic, radioactive resin or glass spheres are introduced into the blood vessels that feed the tumours in the liver. This study found that the addition of SIRT with 90 yttrium-loaded resin microspheres to sorafenib treatment in people with advanced HCC did not significantly improve overall survival compared with sorafenib treatment alone. However, the results give an indication of how future studies using this combination therapy in people with advanced HCC could be designed.
STUDY REGISTRATION
EudraCT 2009-012576-27, NCT0112 6645.",2019,Grades 3-4 were reported in 103/159 (64∙8%),"['216 patients', 'only (p=0∙04), and 8/24 (33∙3', 'patients who only received SIRT', 'patients not eligible for TACE', 'patients with advanced HCC', 'patients with advanced hepatocellular carcinoma (HCC', 'people with advanced HCC', 'advanced hepatocellular carcinoma']","['sorafenib alone', 'SIRT+sorafenib', 'selective internal radiotherapy therapy (SIRT', 'combined selective internal radiation therapy and sorafenib', 'SIRT plus sorafenib (SIRT+sorafenib) or sorafenib alone', 'Sorafenib', 'sorafenib', 'selective internal radiotherapy (SIRT) with yttrium-90 ( 90 Y) resin microspheres and sorafenib']","['Adverse events (AEs) of Common Terminology Criteria for AE', 'overall survival', 'Median OS', 'survival benefit of SIRT+sorafenib', 'efficacy and safety', 'overall survival (OS; Kaplan-Meier analysis) in the intention-to-treat (ITT) population', 'OS']","[{'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1136177', 'cui_str': 'SIRTs'}, {'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0555352', 'cui_str': 'Internal radiotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1136177', 'cui_str': 'SIRTs'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1831994'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0303596', 'cui_str': '90Y radioisotope'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",216.0,0.251653,Grades 3-4 were reported in 103/159 (64∙8%),"[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ricke', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany. Electronic address: jens.ricke@med.uni-muenchen.de.'}, {'ForeName': 'Heinz Josef', 'Initials': 'HJ', 'LastName': 'Klümpen', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Amthauer', 'Affiliation': 'Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bargellini', 'Affiliation': 'Department of Interventional Radiology, Pisa University Hospitalvia Paradisa 2, 56100 Pisa, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bartenstein', 'Affiliation': 'Department of Nuclear Medicine, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Enrico N', 'Initials': 'EN', 'LastName': 'de Toni', 'Affiliation': 'Department of Medicine II, Liver Center Munich, University Hospital, Munich, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gasbarrini', 'Affiliation': 'Internal Medicine, Gastroenterology and Hepatic Diseases Unit, IRCCS Fondazione Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Pech', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Magdeburg, Leipziger Str. 44, 39120 Magdeburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Peck-Radosavljevic', 'Affiliation': 'Department of Internal Medicine and Gastroenterology, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Popovič', 'Affiliation': 'Clinical Institute of Radiology, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rosmorduc', 'Affiliation': ""APHP, Hôpital La Pitié Salpêtrière, Service d'Hépato-Gastroentérologie, Paris, France.""}, {'ForeName': 'Eckart', 'Initials': 'E', 'LastName': 'Schott', 'Affiliation': 'Department of Gastroenterology, Hepatology and Diabetology, Internal Medicine II, HELIOS Hospital Emil von Behring, Berlin, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Seidensticker', 'Affiliation': 'University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Verslype', 'Affiliation': 'Department of Digestive Oncology, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Sangro', 'Affiliation': 'Liver Unit, Clinica Universidad de Navarra-IDISNA and CIBEREHD, Pamplona, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malfertheiner', 'Affiliation': 'Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}]",Journal of hepatology,['10.1016/j.jhep.2019.08.006']
2382,31517967,Co-occurrence of Violence-Related Risk and Protective Behaviors and Adult Support Among Male Youth in Urban Neighborhoods.,"Importance
Male youth in lower-resource neighborhoods bear a disproportionate burden of violence involvement, but little is known about clusters of specific violence-related behaviors to inform cross-cutting interventions that address multiple forms of violence.
Objective
To examine associations between adult support and patterns of violence and risk or protective behavior co-occurrence among male youths in urban neighborhoods.
Design, Setting, and Participants
Cross-sectional analysis of baseline and end-of-program data from a recently completed cluster-randomized sexual violence prevention trial across 20 lower-resource neighborhoods. Participants were male youths, aged 13 to 19 years, enrolled at youth-serving community agencies in Pittsburgh, Pennsylvania, from July 27, 2015, to June 5, 2017. Data were analyzed from July 1, 2018, to February 28, 2019.
Exposures
Social support and natural mentoring, as defined by validated survey measures.
Main Outcomes and Measures
Validated survey measures (youth violence, bullying, sexual and dating violence, history of exposure to violence and related adversities, substance use, school engagement, and future orientation) were assessed for detailed co-occurrence patterns using hierarchical clustering, dendrograms, and heatmaps across prespecified domains. Wilcoxon rank sum tests and logistic regression models examined associations between adult support and violence involvement.
Results
Among 866 participants, the mean (SD) age was 15.5 (1.6) years and 632 participants (77.5%) identified as African American. All 866 participants completed baseline surveys and 577 completed end-of-program surveys. Seven clusters of risk and protective behaviors emerged: (1) school engagement; (2) career and future aspirations; (3) substance use and bullying exposure; (4) exposure to violence and related adversities, sexual violence exposure, peer delinquency, and gang involvement; (5) sexual violence, youth violence, and bullying perpetration; (6) dating abuse perpetration; and (7) physical or sexual partner violence perpetration. The strongest association cluster occurred among sexual violence perpetration behaviors. Youth with high social support engaged in significantly fewer of the 40 prespecified risk behaviors (high social support median [interquartile range], 8 [5-12] behaviors vs low social support median [interquartile range], 10 [6-14] behaviors; mean difference, 1.64 behaviors; 95% CI, 0.63-2.64 behaviors; P = .004). High social support and natural mentoring were both inversely associated with gang involvement (social support: odds ratio [OR], 0.39; 95% CI, 0.22-0.71; and natural mentoring: OR, 0.44; 95% CI, 0.25-0.76) and sexual violence exposure (social support: OR, 0.39; 95% CI, 0.24-0.64; and natural mentoring: OR, 0.61; 95% CI, 0.39-0.98).
Conclusions and Relevance
These findings suggest that co-occurrence of risk and protective behaviors differ significantly among youth with vs without adult support. Violence prevention interventions designed to leverage adult support should address broader co-occurrence patterns.",2019,"High social support and natural mentoring were both inversely associated with gang involvement (social support: odds ratio [OR], 0.39; 95% CI, 0.22-0.71; and natural mentoring: OR, 0.44; 95% CI, 0.25-0.76) and sexual violence exposure (social support: OR, 0.39; 95% CI, 0.24-0.64; and natural mentoring: OR, 0.61; 95% CI, 0.39-0.98).
","['Participants were male youths, aged 13 to 19 years, enrolled at youth-serving community agencies in Pittsburgh, Pennsylvania, from July 27, 2015, to June 5, 2017', 'male youths in urban neighborhoods', 'Importance\n\n\nMale youth in lower-resource neighborhoods', 'the mean (SD) age was 15.5 (1.6) years and 632 participants (77.5%) identified as African American', '866 participants', 'Male Youth in Urban Neighborhoods', 'Participants\n\n\nCross-sectional analysis of baseline and end-of-program data from a recently completed cluster-randomized sexual violence prevention trial across 20 lower-resource neighborhoods', 'All 866 participants completed baseline surveys and 577 completed end-of-program surveys']",[],"['risk and protective behaviors emerged: (1) school engagement; (2) career and future aspirations; (3) substance use and bullying exposure; (4) exposure to violence and related adversities, sexual violence exposure, peer delinquency, and gang involvement; (5) sexual violence, youth violence, and bullying perpetration; (6) dating abuse perpetration; and (7) physical or sexual partner violence perpetration', 'Main Outcomes and Measures\n\n\nValidated survey measures (youth violence, bullying, sexual and dating violence, history of exposure to violence and related adversities, substance use, school engagement, and future orientation', 'risk and protective behaviors', 'High social support and natural mentoring', 'sexual violence exposure']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0814549', 'cui_str': 'Exposure to Violence'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0522174', 'cui_str': 'Delinquent behavior (finding)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}]",866.0,0.049639,"High social support and natural mentoring were both inversely associated with gang involvement (social support: odds ratio [OR], 0.39; 95% CI, 0.22-0.71; and natural mentoring: OR, 0.44; 95% CI, 0.25-0.76) and sexual violence exposure (social support: OR, 0.39; 95% CI, 0.24-0.64; and natural mentoring: OR, 0.61; 95% CI, 0.39-0.98).
","[{'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Culyba', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UMPC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UMPC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Sciences, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11375']
2383,31517964,Effect of a Prize-Linked Savings Intervention on Savings and Healthy Behaviors Among Men in Kenya: A Randomized Clinical Trial.,"Importance
Interventions to reduce men's alcohol use and risky sexual behaviors are essential for reducing new HIV infections in high-prevalence settings in sub-Saharan Africa. Prize-linked savings accounts can motivate savings and may decrease expenditures on risky behaviors, but few studies have examined the HIV prevention potential of such savings interventions among men.
Objective
To evaluate the effect of prize-linked savings accounts on savings behavior and expenditures on alcohol, gambling, and transactional sex among men in Kenya.
Design, Setting, and Participants
Randomized clinical trial among communities in Siaya County, Kenya. Participants were men 21 years or older who owned a mobile phone, were engaged in fishing or transportation sector work, and were willing to open an account with a local bank; they were screened for eligibility between September 3 and October 5, 2018.
Interventions
Eligible participants were offered savings accounts endowed with 1000 Kenya shillings (US $10) and randomized (1:1) to receive weekly lottery-based rewards contingent on growth in savings balance or to a control group that received standard interest.
Main Outcomes and Measures
The primary outcome was an indicator of whether a participant saved any money in the bank account (intent-to-treat analysis) during the study period. Secondary outcomes included total amount saved in the bank account, total amount saved in all sources, and expenditures on alcohol, gambling, and transactional sex.
Results
A total of 425 men were screened, 329 (77.4%) met eligibility criteria, 300 (70.6%) were enrolled (with 152 randomized to the intervention group and 148 to the control group), and 270 of 300 (90.0%) opened bank accounts. Participants' mean age was 33.7 years (interquartile range, 13.5 years), 84.3% (253 of 300) were married, and the mean weekly earnings were US $30 (interquartile range, US $23). During a mean (SD) follow-up of 9 (2) weeks, 37.3% (50 of 134) in the intervention group saved money in a bank account vs 27.2% (37 of 136) in the control group, although the difference was not statistically significant (odds ratio, 1.62; 95% CI, 0.96-2.74). The intervention group had higher growth in bank savings balances (US $10.26; 95% CI, US $5.00-US $58.20 vs US $4.87; 95% CI, US $0.67-US $9.00) and higher total savings from all sources (US $201; 95% CI, US $133-US $269 vs US $145; 95% CI, US $88-US $202), but neither difference was statistically significant. The intervention did not have a significant effect on alcohol, gambling, and transactional sex expenditures.
Conclusions and Relevance
Prize-linked savings accounts modestly increased savings among high-risk men in Kenya over a 9-week period, but the difference compared with standard-interest savings accounts was not significant. Testing of more powerful savings products is needed to assess whether such savings-led interventions can reduce men's expenditures on alcohol, gambling, and transactional sex.
Trial Registration
Social Science Registry identifier: AEARCTR-0003224, and ClinicalTrials.gov identifier: NCT04013295.",2019,"The intervention group had higher growth in bank savings balances (US $10.26; 95% CI, US $5.00-US $58.20 vs US $4.87; 95% CI, US $0.67-US $9.00) and higher total savings from all sources (US $201; 95% CI, US $133-US $269 vs US $145; 95% CI, US $88-US $202), but neither difference was statistically significant.","[""Participants' mean age was 33.7 years (interquartile range, 13.5 years), 84.3% (253 of 300) were married, and the mean weekly earnings were US $30 (interquartile range, US $23"", 'A total of 425 men were screened, 329 (77.4%) met eligibility criteria, 300 (70.6%) were enrolled (with 152 randomized to the intervention group and 148 to the control group), and 270 of 300 (90.0%) opened bank accounts', 'Participants were men 21 years or older who owned a mobile phone, were engaged in fishing or transportation sector work, and were willing to open an account with a local bank; they were screened for eligibility between September 3 and October 5, 2018', 'men', 'Men in Kenya', 'communities in Siaya County, Kenya', 'men in Kenya']","['prize-linked savings', 'weekly lottery-based rewards contingent on growth in savings balance or to a control group that received standard interest', 'Prize-Linked Savings Intervention']","['total amount saved in the bank account, total amount saved in all sources, and expenditures on alcohol, gambling, and transactional sex', 'higher growth in bank savings balances', 'indicator of whether a participant saved any money in the bank account (intent-to-treat analysis', 'Savings and Healthy Behaviors', 'total savings', 'alcohol, gambling, and transactional sex expenditures', 'savings behavior and expenditures on alcohol, gambling, and transactional sex']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4042872', 'cui_str': 'Bank Accounts'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0080049', 'cui_str': 'Prizes'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4042872', 'cui_str': 'Bank Accounts'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",425.0,0.0919333,"The intervention group had higher growth in bank savings balances (US $10.26; 95% CI, US $5.00-US $58.20 vs US $4.87; 95% CI, US $0.67-US $9.00) and higher total savings from all sources (US $201; 95% CI, US $133-US $269 vs US $145; 95% CI, US $88-US $202), but neither difference was statistically significant.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moscoe', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kawango', 'Initials': 'K', 'LastName': 'Agot', 'Affiliation': 'Impact Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11162']
2384,31519516,"Complications and Adverse Events of Three Magnetic Resonance Imaging-based Target Biopsy Techniques in the Diagnosis of Prostate Cancer Among Men with Prior Negative Biopsies: Results from the FUTURE Trial, a Multicentre Randomised Controlled Trial.","BACKGROUND
Three techniques of magnetic resonance imaging (MRI)-based targeted biopsy (TB) of the prostate exist. There is no superiority regarding diagnostic efficacy of prostate cancer (PCa) detection.
OBJECTIVE
To compare adverse events (AEs) among three TB techniques and to evaluate the effect on urinary and erectile function.
DESIGN, SETTING, AND PARTICIPANTS
Post hoc analysis of a multicentre randomised controlled trial among men with negative systematic biopsy (SB) and suspicion of PCa.
INTERVENTION
In 234 patients, 3-T multiparametric MRI demonstrated PIRADS≥ 3 lesions, and patients were randomised 1:1:1 for TB: transrectal in-bore MRI TB (MRI-TB), transperineal MRI-transrectal ultrasound (TRUS) fusion TB (FUS-TB), and transrectal cognitive TRUS TB (COG-TB).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
AEs (Clavien-Dindo) were compared using Pearson chi-square test. Univariate logistic regression tests were performed for the number of cores, biopsy approach, and usage of anticoagulants. The participants filled in baseline and 30-d postbiopsy International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) questionnaires. The delta between measurements was compared using one-way analysis of variance.
RESULTS AND LIMITATIONS
There were significant differences in minor AEs: 53% in MRI-TB, 71% in FUS-TB, and 85% in COG-TB (p < 0.001). The number of cores was associated with AEs (odds ratio [OR] 1.11 per extra biopsy [95% confidence interval {CI} 1.06-1.17, p < 0.001]). Anticoagulants were not associated with bleeding complications (OR 1.24 [95% CI 0.66-2.35, p = 0.5]). Transrectal approach (MRI-TB + COG-TB) increased the risk of any AE (OR 2.54 [95% CI 1.16-5.77, p < 0.05]) and nonsignificantly increased the risk of urinary tract infections (OR 3.69 [95% CI 0.46-168.4, p = 0.3]). Biopsy did not impact urinary (ΔIPSS 0.3, p = 0.1) and erectile function (ΔIIEF-5 -0.4, p = 0.5). The main limitation was that additional SB was performed in FUS-TB and COG-TB, and was omitted in MRI-TB, making comparison difficult.
CONCLUSIONS
There was a significant difference in minor AEs among groups. An increase in the number of cores increased the overall risk of AEs. A low AE occurrence in MRI-TB was likely caused by the omission of SB. Prostate biopsy did not impact self-reported urinary and erectile functions.
PATIENT SUMMARY
In this study, we compared the complication rates of three techniques of magnetic resonance imaging (MRI)-based targeted biopsy of the prostate. We found a significant difference in the occurrence of minor complication rates among three groups in favour of transrectal in-bore MRI targeted biopsy, likely caused by the omission of additional systematic biopsy in this group.",2019,"Biopsy did not impact urinary (ΔIPSS 0.3, p = 0.1) and erectile function (ΔIIEF-5 -0.4, p = 0.5).","['men with negative systematic biopsy (SB) and suspicion of PCa', 'Men with Prior Negative Biopsies', '234 patients, 3-T multiparametric MRI demonstrated PIRADS≥ 3 lesions, and patients']","['Transrectal approach (MRI-TB\u202f+\u202fCOG-TB', 'Magnetic Resonance Imaging-based Target Biopsy Techniques', 'magnetic resonance imaging (MRI)-based targeted biopsy of the prostate', 'magnetic resonance imaging (MRI)-based targeted biopsy (TB']","['erectile function', 'risk of any AE (OR', 'bleeding complications (OR', 'complication rates', 'occurrence of minor complication rates', 'overall risk of AEs', 'MRI TB (MRI-TB), transperineal MRI-transrectal ultrasound (TRUS) fusion TB (FUS-TB), and transrectal cognitive TRUS TB (COG-TB', 'postbiopsy International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) questionnaires', 'risk of urinary tract infections']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1097281', 'cui_str': '3-(DMP)-T'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205500', 'cui_str': 'Perineal approach (qualifier value)'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",234.0,0.447051,"Biopsy did not impact urinary (ΔIPSS 0.3, p = 0.1) and erectile function (ΔIIEF-5 -0.4, p = 0.5).","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Wegelin', 'Affiliation': 'Department of Urology, St. Antonius Hospital, Nieuwegein/Utrecht, The Netherlands. Electronic address: o.wegelin@antoniusziekenhuis.nl.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Exterkate', 'Affiliation': 'Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'van der Leest', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': 'Department of Epidemiology, St. Antonius Hospital, Nieuwegein/Utrecht, The Netherlands.'}, {'ForeName': 'J L H Ruud', 'Initials': 'JLHR', 'LastName': 'Bosch', 'Affiliation': 'Department of Urology, UMC, Utrecht, The Netherlands.'}, {'ForeName': 'Jelle O', 'Initials': 'JO', 'LastName': 'Barentsz', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Diederik M', 'Initials': 'DM', 'LastName': 'Somford', 'Affiliation': 'Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Harm H E', 'Initials': 'HHE', 'LastName': 'van Melick', 'Affiliation': 'Department of Urology, St. Antonius Hospital, Nieuwegein/Utrecht, The Netherlands.'}]",European urology oncology,['10.1016/j.euo.2019.08.007']
2385,31514191,Evaluating the Outcome of Two Different Regimes in Adhesive Capsulitis: A Prospective Clinical Study.,"OBJECTIVE
Adhesive capsulitis or frozen shoulder is a painful condition affecting up to 5% of the general population. We conducted this study with the aim of evaluating the results of physiotherapy plus intra-articular methylprednisolone injection versus physiotherapy alone in idiopathic frozen shoulder.
METHODS
This prospective clinical study was conducted in a tertiary care center between August 2016 and August 2018. Patients who were diagnosed with idiopathic frozen shoulder were included in the study, and each patient was randomly allocated to one of two groups: physiotherapy alone (group A) and physiotherapy plus intra-articular steroid injection (group B).
RESULTS
A total of 52 cases diagnosed with idiopathic frozen shoulder were included and treated with the two modalities. There was a significant improvement in group B compared to group A at 6 weeks and 3 months in the range of flexion, abduction, and external rotation. The Shoulder Pain and Disability Index showed improvement in both pain and disability score in group B -compared to group A, and improvement was significant at 6 weeks and 3 months.
CONCLUSION
The results demonstrate the advantages of physiotherapy plus intra-articular steroid injection in idiopathic frozen shoulder. The predictability of results with physiotherapy plus intra-articular steroid injection in selected patients is excellent, and it is a better modality of treatment compared to physiotherapy alone.",2020,"There was a significant improvement in Group B as compared to Group A at 6 weeks and 3 months in the range of flexion, abduction and external rotation.","['52 cases diagnosed with idiopathic frozen shoulder', 'tertiary care centre between August 2016 to August 2018', 'Patients who were diagnosed with idiopathic frozen shoulder were included in the study and each patient', 'idiopathic frozen shoulder', 'Adhesive Capsulitis']","['intra-articular methylprednisolone with physiotherapy versus physiotherapy alone', 'intra-articular steroid plus physiotherapy', 'physiotherapy alone and physiotherapy and intra articular injection', 'physiotherapy alone (Group A) and physiotherapy and intra-articular steroid injection (Group B']","['Shoulder pain and disability index (SPADI', 'pain and disability score']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0158300', 'cui_str': 'Adhesive Capsulitis'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0429527,"There was a significant improvement in Group B as compared to Group A at 6 weeks and 3 months in the range of flexion, abduction and external rotation.","[{'ForeName': 'Rashid', 'Initials': 'R', 'LastName': 'Anjum', 'Affiliation': 'ASCOMS & Hospital, Jammu, India, raashidanjum@gmail.com.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Aggarwal', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Gautam', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}, {'ForeName': 'Aryan', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'MM Institute of Medical Sciences and Research, Ambala, India.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000503317']
2386,31176622,Clinical and Biological Characterisation of Localised High-risk Prostate Cancer: Results of a Randomised Preoperative Study of a Luteinising Hormone-releasing Hormone Agonist with or Without Abiraterone Acetate plus Prednisone.,"Optimal therapeutic strategy remains an unmet need in localised high-risk prostate cancer (LHRPC). Androgen biosynthesis inhibition in the preoperative setting may improve outcomes. In this single-centre randomised trial, we looked at therapy outcomes of preoperative treatment with abiraterone acetate+prednisone (AAP)+luteinising hormone-releasing hormone agonist (LHRHa) or LHRHa alone followed by radical prostatectomy in 65 men. We did not see a significant difference of organ-confined carcinoma (p=0.27). However, tumour volume measures were significantly lower for AAP+LHRHa treatment (p≤0.001). Of note, lower tumour epithelium volume correlated with improved biochemical recurrence-free survival at ≥4-yr follow-up (p=0.0014). Tumours pretreated with AAP+LHRHa had lower proliferation and androgen signalling expression than LHRHa. On multivariate analysis, glucocorticoid receptor (GR) overexpression correlated with persistent tumours in AAP+LHRHa (p=0.018). The presence of nuclear androgen receptor splice variant (nARV7) correlated with persistent tumours in both arms. No new safety signals were observed. This is the first study investigating the role of preoperative AAP+LHRHa versus LHRHa alone in LHRPC. We report significant cytoreduction by tumour volume measures inversely correlating with biochemical relapse. Validation of these proposed tumour volume measures is planned. A potential role of GR in resistance to androgen biosynthesis inhibition warrants further study. PATIENT SUMMARY: This is the first study of abiraterone acetate plus leuprolide versus leuprolide alone in high-risk localised prostate cancer followed by prostatectomy. Patients in the combination arm had a significantly smaller tumour size.",2019,"However, tumour volume measures were significantly lower for AAP+LHRHa treatment (p≤0.001).","['65 men', 'high-risk localised prostate cancer followed by prostatectomy', 'Localised High-risk Prostate Cancer']","['leuprolide alone', 'abiraterone acetate plus leuprolide', 'preoperative AAP+LHRHa versus LHRHa', 'Luteinising Hormone-releasing Hormone Agonist with or Without Abiraterone Acetate plus Prednisone', 'AAP+LHRHa', 'abiraterone acetate+prednisone (AAP)+luteinising hormone-releasing hormone agonist (LHRHa) or LHRHa alone followed by radical prostatectomy']","['smaller tumour size', 'lower proliferation and androgen signalling expression', 'tumour volume measures', 'glucocorticoid receptor (GR) overexpression', 'biochemical recurrence-free survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0475277', 'cui_str': 'Small tumor (finding)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid Receptor'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}]",65.0,0.0368284,"However, tumour volume measures were significantly lower for AAP+LHRHa treatment (p≤0.001).","[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Clinical Therapeutics, University of Athens, Athens, Greece. Electronic address: eefstathiou@mdanderson.org.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Davis', 'Affiliation': 'Division of Surgery, Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Pisters', 'Affiliation': 'Division of Surgery, Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Biostatistics, West Virginia University School of Public Health, Morgantown, WV, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'McMullin', 'Affiliation': 'LabConnect LLC, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gormley', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ricci', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Titus', 'Affiliation': 'Department of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Hoang', 'Affiliation': 'Department of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Amado J', 'Initials': 'AJ', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'NamPhuong', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Clinical Research & Development, Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Clinical Research & Development, Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Thian', 'Initials': 'T', 'LastName': 'Kheoh', 'Affiliation': 'Department of Biostatistics & Programming, Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Molina', 'Affiliation': 'Oncology Science Innovation, Janssen Research & Development, Menlo Park, CA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Troncoso', 'Affiliation': 'Division of Pathology and Laboratory Medicine, Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Logothetis', 'Affiliation': 'Department of Genitourinary Medical Oncology, David H. Koch Center for Applied Research of GU Cancers, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",European urology,['10.1016/j.eururo.2019.05.010']
2387,32127350,Impact of Social Support on Colorectal Cancer Screening among Adult Hispanics/Latinos: A Randomized Community-based Study in Central Pennsylvania.,"In the United States, the five-year survival rate of colorectal cancer for Latinos is lower than it is for White, non-Latinos. Differences in survival are due, in part, to Latinos being diagnosed at a later stage. An ethnic gap in the use of colorectal cancer screening contributes to the difference in survival. We developed, implemented, and evaluated a targeted colorectal cancer screening intervention to increase colorectal cancer screening uptake by sex, ethnicity, and geography. We measured actual colorectal cancer screening uptake in both arms as a method to determine completion rates. We used a randomized, community-based, participatory design to test the impact of social support (intervention) on completion of a provider-recommended, take-home fecal immunochemical test (FIT) kit screening test among average-risk, urban, and rural Pennsylvania Latino adults age 50 and older not currently adherent to national colorectal cancer screening guidelines ( n = 264). Participants in each arm attended a community-based educational program offered at eight sites. Among the 264 participants, 154 (58%) returned a completed usable FIT kit screening test. A higher return rate was observed among participants in the social support arm (66.0%) compared with the control (47.2%). Participants in the social support arm were statistically significant 2.67 times as likely to return a completed FIT kit. Of these, 27 (17.5%) had a positive FIT kit screening test result. The results of this study suggest that social support is an effective method to increase colorectal cancer screening rates among Latinos. Future studies should examine dissemination and implementation of community-based strategies among Latinos that include social support.",2020,A higher return rate was observed among participants in the social support arm (66.0%) compared to the control (47.2%).,"['average-risk, urban and rural Pennsylvania Latino adults age 50 and older not currently adherent to national CRC screening guidelines (n=264', '264 participants, 154 (58%) returned a completed usable FIT kit screening test', 'Latinos', 'Adult Hispanics']","['social support (intervention', 'Social Support', 'CRC screening intervention', 'provider-recommended, take-home fecal immunochemical test (FIT) kit screening test']","['survival', 'CRC screening rates', 'return rate', 'actual CRC screening uptake']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0037438'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",264.0,0.0226142,A higher return rate was observed among participants in the social support arm (66.0%) compared to the control (47.2%).,"[{'ForeName': 'Oralia G', 'Initials': 'OG', 'LastName': 'Dominic', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania. Dr.Oralia@gmail.com.'}, {'ForeName': 'Vern', 'Initials': 'V', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wasserman', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Curry', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Kambic', 'Affiliation': 'Kambic Family Clinic, Steelton, Pennsylvania.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Caicedo', 'Affiliation': 'Pinnacle Health System, Harrisburg, Pennsylvania.'}, {'ForeName': 'Amelie G', 'Initials': 'AG', 'LastName': 'Ramirez', 'Affiliation': 'Institute for Health Promotion Research, Health Disparities Research, UT Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ochoa', 'Affiliation': 'Department of Spanish, Italian and Portuguese, College of Health and Human Development, The Pennsylvania State University, State College, Pennsylvania.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Lengerich', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0333']
2388,32494976,"A daily study of stressors, continuously measured glucose, and diabetes symptoms in latinos with type 2 diabetes.","This study examined whether daily stressors and continuously monitored glucose levels and glucose variability predict daily diabetes symptoms. Fifty Latinos with type 2 diabetes were randomized to either diabetes education (DE-only; N = 23) or DE plus stress management and relaxation training (DE + SMR; N = 32). After treatment, for 7 days they wore 'blinded' continuous glucose monitors and reported common stressors and diabetes symptoms twice daily. Between individuals, participants with more numerous overall stressors and more time in hyperglycemia reported higher symptoms. Within individuals, symptoms were higher during intervals of greater than usual stressors. Yet, diabetes symptoms did not covary with changes in glucose levels or glucose variability. The within-person stressor-symptom association was stronger among older individuals and non-significant for participants in DE + SMR condition. Diabetes symptoms were associated with recent stressor exposure, but not recent glucose level or changes in glucose. CLINICAL TRIAL NUMBER: ClinicalTrials.gov Identifier (No. NCT01578096).",2020,The within-person stressor-symptom association was stronger among older individuals and non-significant for participants in DE + SMR condition.,"['Fifty Latinos with type 2 diabetes', 'latinos with type 2 diabetes']",['diabetes\xa0education (DE-only; N\u2009=\u200923) or\xa0DE plus stress management and relaxation training (DE\u2009+\u2009SMR; N\u2009=\u200932'],[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0036154', 'cui_str': 'San Marino'}]",[],50.0,0.0350559,The within-person stressor-symptom association was stronger among older individuals and non-significant for participants in DE + SMR condition.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'Division of Behavioral Sciences and Community Health and Department of Psychiatry, UConn Schools of Dental Medicine and Medicine, UConn Health, 263 Farmington Ave, Farmington, CT, 06030, USA. juwagner@uchc.edu.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Armeli', 'Affiliation': 'Department of Psychology, Farleigh Dickinson University, Teaneck, NJ, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Tennen', 'Affiliation': 'Department of Public Health Sciences, UConn School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bermudez-Millan', 'Affiliation': 'Department of Public Health Sciences, UConn School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Wolpert', 'Affiliation': 'Harvard Medical School, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Pérez-Escamilla', 'Affiliation': 'Yale School of Public Health, New Haven, CT, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-020-00162-1']
2389,32493267,Effectiveness of a progressive resistance exercise program for industrial workers during breaks on perceived fatigue control: a cluster randomized controlled trial.,"BACKGROUND
There is strong evidence that physical exercise in the workplace is effective for reducing workers' musculoskeletal complaints. Studies with industrial workers and studies on progressive resistance exercises during breaks are scarce. Our aim was to evaluate the effects of a resistance exercise program on perceived fatigue control among industrial workers.
METHODS
204 employees from the dairy industry were allocated to two groups, the intervention group (IG) (n = 98) and the control group (CG) (n = 106). The primary outcome measures were perceived fatigue control and maximum muscle strength, measured through the Need for Recovery Scale and one-repetition maximum contraction (1-RM), respectively. Secondary outcome measures were musculoskeletal complaints, physical activity level, perceived risk factors, physical fitness (BMI, vital signs, and body fat percentage), and workers´ productivity. All outcomes were assessed at baseline and then again after 4 months. The IG performed resistance exercises using progressively greater loads while the CG performed general exercise using elastic bands. The exercise protocols were performed three times per week for 20 min. An intention-to-treat analysis was performed using the mixed linear model. Results were considered significant when p < 0.05.
RESULTS
The IG did not show to be superior to the CG, although both groups improved perceived fatigue control and muscle strength after the resistance physical exercise program in the worplace. There was also no significant difference between the groups for musculoskeletal complaints and other secondary variables analyzed. However, both groups showed significant improvements between baseline and after 4 months of intervention for all evaluated outcomes (p < 0.05).
CONCLUSION
The implementation of a progressive resistance exercise program during work breaks for perceived fatigue control was no more effective than exercises using elastic bands. However, resistance exercises during work breaks presented better results on all measured outcomes regardless of the exercise protocol used.
TRIAL REGISTRATION
U.S. National Institutes of Health, ClinicalTrials.gov Identifier: NCT02172053. Registered 19 June 2014.",2020,"The IG did not show to be superior to the CG, although both groups improved perceived fatigue control and muscle strength after the resistance physical exercise program in the worplace.","[""workers' musculoskeletal complaints"", 'industrial workers during breaks on perceived fatigue control', 'industrial workers', '204 employees from the dairy industry']","['control group (CG', 'resistance exercise program', 'progressive resistance exercise program', 'physical exercise']","['fatigue control and maximum muscle strength, measured through the Need for Recovery Scale and one-repetition maximum contraction (1-RM', 'musculoskeletal complaints', 'fatigue control and muscle strength', 'progressive resistance exercises', 'musculoskeletal complaints, physical activity level, perceived risk factors, physical fitness (BMI, vital signs, and body fat percentage), and workers´ productivity']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C4279966', 'cui_str': 'Dairy Industry'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",204.0,0.0894599,"The IG did not show to be superior to the CG, although both groups improved perceived fatigue control and muscle strength after the resistance physical exercise program in the worplace.","[{'ForeName': 'Hélio Gustavo', 'Initials': 'HG', 'LastName': 'Santos', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Luciana Dias', 'Initials': 'LD', 'LastName': 'Chiavegato', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Daniela Pereira', 'Initials': 'DP', 'LastName': 'Valentim', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Rosimeire Simprini', 'Initials': 'RS', 'LastName': 'Padula', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil. rosimeire.padula@unicid.edu.br.'}]",BMC public health,['10.1186/s12889-020-08994-x']
2390,32493318,Impact of take-home messages written into slide presentations delivered during lectures on the retention of messages and the residents' knowledge: a randomized controlled study.,"BACKGROUND
Lectures with slide presentations are widely used to teach evidence-based medicine to large groups. Take-home messages (THMs) are poorly identified and recollected by students. We investigated whether an instruction to list THMs in written form on slides would improve the retention thereof by residents, and the residents' level of knowledge, 1 month after lectures.
METHODS
Prospective blinded randomized controlled study was conducted. Twelve lectures (6 control and 6 intervention lectures) were delivered to 73 residents. For the intervention lectures, the lecturers were instructed to incorporate clear written THMs into their slide presentations. The outcomes were ability of resident to recollect THMs delivered during a lecture (as assessed by accordance rate between the lecturers' and residents' THMs) and knowledge (as assessed by multiple choice questions (MCQs)).
RESULTS
Data for 3738 residents' THMs and 3410 MCQs were analyzed. The intervention did not significantly increase the number of THMs written on slides (77% (n = 20/26), 95% CI 56-91 vs 64% (n = 18/28), 95% CI 44-81, p = 0.31) nor THMs retention (13% (n = 238/1791), 95% CI 12-15 vs 17% (n = 326/1947), 95% 15-18, p = 0.40) nor knowledge (63.8 ± 26.2 vs 61.1 ± 31.4 /100 points, p = 0.75). In multivariable analyses performed with all THMs written on slides from the two groups, a superior knowledge was associated with notetaking during lectures (OR 1.88, 95% CI 1.41-2.51) and THMs retention (OR 2.17, 95% CI 1.54-3.04); and THMs retention was associated with written THMs (OR 2.94, 95% CI 2.20-3.93).
CONCLUSIONS
In lectures delivered to residents, a third of the THMs were not in written form. An intervention based on an explicit instruction to lecturers to provide THMs in written form in their slide presentations did not result in increased use of written THMs into the slide presentation or improvement of the THMs retention or level of knowledge. However, we showed that there was a strong positive association between writing THMs on a slide, retention of THMs and residents' knowledge. Further researches are needed to assess interventions to increase written THMs in lectures by faculty.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01795651 (Fev 21, 2013).",2020,"The intervention did not significantly increase the number of THMs written on slides (77% (n = 20/26), 95% CI 56-91 vs 64% (n = 18/28), 95% CI 44-81, p = 0.31) nor THMs retention (13% (n = 238/1791), 95% CI 12-15 vs 17% (n = 326/1947), 95% 15-18, p = 0.40) nor knowledge (63.8 ± 26.2 vs 61.1 ± 31.4 /100 points, p = 0.75).","[""3738 residents' THMs and 3410 MCQs""]",[],"['THMs retention or level of knowledge', 'THMs retention', ""ability of resident to recollect THMs delivered during a lecture (as assessed by accordance rate between the lecturers' and residents' THMs) and knowledge (as assessed by multiple choice questions (MCQs"", 'number of THMs written on slides']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],"[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}]",,0.0987876,"The intervention did not significantly increase the number of THMs written on slides (77% (n = 20/26), 95% CI 56-91 vs 64% (n = 18/28), 95% CI 44-81, p = 0.31) nor THMs retention (13% (n = 238/1791), 95% CI 12-15 vs 17% (n = 326/1947), 95% 15-18, p = 0.40) nor knowledge (63.8 ± 26.2 vs 61.1 ± 31.4 /100 points, p = 0.75).","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Intensive Care Medicine, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France. alautrette@chu-clermontferrand.fr.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Boyer', 'Affiliation': 'Intensive Care Unit, Pellegrin-Tripode Hospital, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Gruson', 'Affiliation': 'Intensive Care Unit, Pellegrin-Tripode Hospital, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Argaud', 'Affiliation': 'Intensive Care Unit, Edouard Herriot Hospital, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Schwebel', 'Affiliation': 'Intensive Care Unit, Albert Michallon Hospital, University Hospital of Grenoble, Grenoble, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Tardy', 'Affiliation': 'Clinical Investigation Center-CIC 1408, Nord Teaching Hospital, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Vignon', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Dupuytren Hospital, University Hospital of Limoges, Limoges, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Megarbane', 'Affiliation': 'Department of Medical and Toxicological Critical Care, Lariboisière Hospital, Assistance Publique - Hopitaux de Paris, INSERM UMRS-1144, Paris-Diderot University, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Schoeffler', 'Affiliation': 'Intensive Care Unit, Department of Anaesthesiology, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Chabrot', 'Affiliation': 'Department of Radiology, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Jeannot', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Adult Emergency Department, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Nutrition Unit, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Guerin', 'Affiliation': 'Intensive Care Unit, Croix Rousse Hospital, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Darmon', 'Affiliation': 'Intensive Care Unit, Nord Teaching Hospital, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Kada', 'Initials': 'K', 'LastName': 'Klouche', 'Affiliation': 'Intensive Care Unit, Lapeyronie Hospital, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Souweine', 'Affiliation': 'LMGE «Laboratoire Micro-organismes: Génome et Environnement», UMR CNRS 6023, Clermont-Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Intensive Care Unit, l'Archet Hospital, Cote d'Azur University, Nice, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics unit, Delegation à la Recherche Clinique (DRCI), University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medical education,['10.1186/s12909-020-02092-7']
2391,31383985,Survival benefits of dose-dense early postoperative intraperitoneal chemotherapy in front-line therapy for advanced ovarian cancer: a randomised controlled study.,"Dose-dense early postoperative intraperitoneal chemotherapy (DD-EPIC) significantly increased non-progression rate in advanced ovarian cancer (OC) patients. We report final overall survival (OS) results to further strengthen the efficacy of DD-EPIC in the front-line therapy. In this phase 2 trial, 218 patients with FIGO IIIC-IV OC were randomly allocated to receive DD-EPIC followed by intravenous (IV) chemotherapy (DD-EPIC group), or IV chemotherapy alone (IV group). The study was prespecified to detect differences in progression-free survival (PFS) and OS. At a median follow-up period of 69.1 months, the median OS was 67.5 and 46.3 months in the DD-EPIC and IV group, respectively. The probability rate of OS at 5 years was 61.0% with DD-EPIC, and 38.2% with IV (hazard ratio [HR] for death from OC, 0.70; 95% confidence interval [CI], 0.49-1.00). DD-EPIC was associated with a prolonged PFS compared with the IV group (the estimated rate of PFS at 5 years, 26.0% vs. 8.5%; HR for disease progression, 0.64; 95% CI, 0.47-0.86). DD-EPIC was associated with a longer OS than IV chemotherapy alone. It may be considered as a valuable option of the front-line therapy for advanced ovarian cancer.Trial registration: ClinicalTrials.gov, NCT01669226 (date of registration: August 20, 2012).",2019,"DD-EPIC was associated with a prolonged PFS compared with the IV group (the estimated rate of PFS at 5 years, 26.0% vs. 8.5%; HR for disease progression, 0.64; 95% CI, 0.47-0.86).","['advanced ovarian cancer (OC) patients', 'advanced ovarian cancer', '218 patients with FIGO IIIC-IV OC']","['dose-dense early postoperative intraperitoneal chemotherapy', 'Dose-dense early postoperative intraperitoneal chemotherapy (DD-EPIC', 'DD-EPIC followed by intravenous (IV) chemotherapy (DD-EPIC group), or IV chemotherapy alone']","['median OS', 'probability rate of OS', 'Survival benefits', 'progression-free survival (PFS) and OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0413365', 'cui_str': 'Intravenous chemotherapy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",218.0,0.207204,"DD-EPIC was associated with a prolonged PFS compared with the IV group (the estimated rate of PFS at 5 years, 26.0% vs. 8.5%; HR for disease progression, 0.64; 95% CI, 0.47-0.86).","[{'ForeName': 'Tingyan', 'Initials': 'T', 'LastName': 'Shi', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Pu', 'Affiliation': 'Department of Obstetrics and Gynecology, Wuxi Caner Hospital, Jiangsu, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Department of Mathematics and Statistics, Queen's University, Kingston, Canada.""}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': 'Department of Obstetrics and Gynecology, Suzhou Municipal Hospital, Jiangsu, China.'}, {'ForeName': 'Yunlang', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Obstetrics and Gynecology, Zhongda Hospital Southeast University, Jiangsu, China.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Clinical Statistics Center, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Ruiqin', 'Initials': 'R', 'LastName': 'Tu', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Huaying', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Luan', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shumo', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Zang', 'Affiliation': 'Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China. ryzang@yahoo.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-019-0543-1']
2392,32493256,Differences in realized access to healthcare among newly arrived refugees in Germany: results from a natural quasi-experiment.,"BACKGROUND
Germany has a statutory health insurance (SHI) that covers nearly the entire population and most of the health services provided. Newly arrived refugees whose asylum claim is still being processed are initially excluded from the SHI. Instead, their entitlements are restricted and parallel access models have been implemented. We assessed differences in realized access of healthcare services between these access models.
METHODS
In Germany's largest federal state, North Rhine-Westphalia, two different access models have been implemented in the 396 municipalities: the healthcare voucher (HcV) model and the electronic health card (eHC) model. As refugees are quasi-randomly assigned to municipalities, we were able to realize a natural quasi-experiment including all newly assigned refugees from six municipalities (three for each model) in 2016 and 2017. Using claims data, we compared the standardized incidence rates (SIR) of specialist services use, emergency services use, and hospitalization due to ambulatory care sensitive conditions (ACSC) between both models. We indirectly standardized utilization patterns first for age and then for the sex.
RESULTS
SIRs of emergency use were higher in municipalities with HcV (ranging from 1.41 to 2.63) compared to emergency rates in municipalities with eHC (ranging from 1.40 to 1.71) and differed significantly from the expected rates derived from official health reporting. SIRs of emergency and specialist use in municipalities with eHC converged with the expected rates over time. There were no significant differences in standardized hospitalization rates for ACSC.
CONCLUSION
The results suggest that the eHC model is slightly better able to provide refugees with SHI-like access to specialist services and goes along with lower utilization of emergency services compared to the HcV model. No difference between the models was found for hospitalizations due to ACSC. Results might be slightly biased due to incompletely documented service use and due to (self-) selection on the level of municipalities with municipalities interested in facilitating access showing more interest in joining the project.",2020,"RESULTS
SIRs of emergency use were higher in municipalities with HcV (ranging from 1.41 to 2.63) compared to emergency rates in municipalities with eHC",[],['eHC'],"['standardized incidence rates (SIR) of specialist services use, emergency services use, and hospitalization due to ambulatory care sensitive conditions (ACSC', 'standardized hospitalization rates']",[],"[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0302105,"RESULTS
SIRs of emergency use were higher in municipalities with HcV (ranging from 1.41 to 2.63) compared to emergency rates in municipalities with eHC","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Wenner', 'Affiliation': 'Department of Epidemiology & International Public Health, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany. judith.wenner@uni-bielefeld.de.'}, {'ForeName': 'Kayvan', 'Initials': 'K', 'LastName': 'Bozorgmehr', 'Affiliation': 'Department of Population Medicine and Health Services Research, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Duwendag', 'Affiliation': 'Department of Epidemiology & International Public Health, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rolke', 'Affiliation': 'Department of Epidemiology & International Public Health, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Razum', 'Affiliation': 'Department of Epidemiology & International Public Health, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany.'}]",BMC public health,['10.1186/s12889-020-08981-2']
2393,32493276,The effect of intraoperative lidocaine infusion on opioid consumption and pain after totally extraperitoneal laparoscopic inguinal hernioplasty: a randomized controlled trial.,"BACKGROUND
As a component of multimodal analgesia, the administration of systemic lidocaine is a well-known technique. We aimed to evaluate the efficacy of lidocaine infusion on postoperative pain-related outcomes in patients undergoing totally extraperitoneal (TEP) laparoscopies inguinal hernioplasty.
METHODS
In this randomized controlled double-blind study, we recruited 64 patients to receive either lidocaine 2% (intravenous bolus 1.5 mg. kg - 1 followed by an infusion of 2 mg. kg - 1 . h - 1 ), or an equal volume of normal saline. The infusion was initiated just before the induction of anesthesia and discontinued after tracheal extubation. The primary outcome of the study was postoperative morphine equivalent consumption up to 24 h after surgery. Secondary outcomes included postoperative pain scores, nausea/vomiting (PONV), sedation, quality of recovery (scores based on QoR-40 questionnaire), patient satisfaction, and the incidence of chronic pain.
RESULTS
The median (IQR) cumulative postoperative morphine equivalent consumption in the first 24 h was 0 (0-1) mg in the lidocaine group and 4 [1-8] mg in the saline group (p < 0.001). Postoperative pain intensity at rest and during movement at various time points in the first 24 h were significantly lower in the lidocaine group compared with the saline group (p < 0.05). Fewer patients reported PONV in the lidocaine group than in the saline group (p < 0.05). Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001). Patients receiving lidocaine were more satisfied with postoperative analgesia than those receiving saline (p = 0.02). No difference was detected in terms of postoperative sedation and chronic pain after surgery.
CONCLUSIONS
Intraoperative lidocaine infusion for laparoscopic TEP inguinal hernioplasty reduces opioid consumption, pain intensity, PONV and improves the quality of recovery and patient satisfaction.
TRIAL REGISTRATION
ClinicalTrials.gov- NCT02601651. Date of registration: November 10, 2015.",2020,Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001).,"['patients undergoing totally extraperitoneal (TEP) laparoscopies inguinal hernioplasty', '64 patients to receive either', 'after totally extraperitoneal laparoscopic inguinal hernioplasty']","['lidocaine infusion', 'lidocaine', 'intraoperative lidocaine infusion', 'lidocaine 2% (intravenous bolus 1.5\u2009mg']","['postoperative morphine equivalent consumption', 'satisfied with postoperative analgesia', 'postoperative pain scores, nausea/vomiting (PONV), sedation, quality of recovery (scores based on QoR-40 questionnaire), patient satisfaction, and the incidence of chronic pain', 'median (IQR) cumulative postoperative morphine', 'postoperative pain-related outcomes', 'PONV', 'opioid consumption, pain intensity, PONV and improves the quality of recovery and patient satisfaction', 'Median QoR scores', 'opioid consumption and pain', 'Postoperative pain intensity', 'equivalent consumption', 'postoperative sedation and chronic pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.699271,Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001).,"[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Ghimire', 'Affiliation': 'Department of Anesthesiology, Nepal Mediciti Hospital, Lalitpur, Nepal.'}, {'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Subedi', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal. asishsubedi19@gmail.com.'}, {'ForeName': 'Balkrishna', 'Initials': 'B', 'LastName': 'Bhattarai', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Birendra Prasad', 'Initials': 'BP', 'LastName': 'Sah', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal.'}]",BMC anesthesiology,['10.1186/s12871-020-01054-2']
2394,32493248,Prophylactic intra-aortic balloon pump in patients with left main disease undergoing off-pump coronary artery bypass grafting.,"BACKGROUND
Preventive intra-aortic balloon pump (IABP) for high-risk patients with stable hemodynamics is controversial, and its definition of high-risk is still unclear. This study aimed to investigate the effect of prophylactic IABP on the early outcome of left main disease (LMD) patients receiving off-pump coronary artery bypass grafting (OPCABG) with stable hemodynamics.
METHODS
From January 2013 to April 2020, 257 consecutive patients who underwent OPCABG through sternotomy were enrolled in this study. All LMD patients (greater than 70%) had stable hemodynamics (BP>100 mmHg without vasoconstrictor substance infusion). Early outcomes of 125 patients with prophylactic IABP (IABP group) and 132 patients without IABP (Control group) were compared in this study.
RESULTS
IABP did not show favorable effect on the conversion to CPB (RR 0.63, 95%CI 0.05-7.89, P = 0.7211), perioperative MI (RR 0.69, 95%CI 0.22-2.12, P = 0.5163), mortality (RR 0.65, 95%CI 0.04-10.25, P = 0.7608) or the composite end of the conversion, MI and mortality (RR 0.63, 95%CI 0.23-1.74, P = 0.3747). There was greater incidence of prolonged ventilation in IABP after adjustment (RR2.16, 95%CI 1.12-4.18, P = 0.0221). There was no IABP-related mortality or limb ischemia.
CONCLUSION
No significant difference in early outcomes was observed in hemodynamically stable patients with LMD between prophylactic IABP group and control group. Prophylactic IABP may be unnecessary in patients with LMD undergoing OPCABG.",2020,No significant difference in early outcomes was observed in hemodynamically stable patients with LMD between prophylactic IABP group and control group.,"['left main disease (LMD) patients receiving off-pump coronary artery bypass grafting (OPCABG) with stable hemodynamics', 'high-risk patients with stable hemodynamics', '125 patients with prophylactic IABP (IABP group) and 132 patients without IABP (Control group', 'From January 2013 to April 2020, 257 consecutive patients who underwent OPCABG through sternotomy were enrolled in this study', 'patients with left main disease undergoing off-pump coronary artery bypass grafting', 'patients with LMD undergoing OPCABG']","['Prophylactic intra-aortic balloon pump', 'prophylactic IABP', 'Preventive intra-aortic balloon pump (IABP', 'Prophylactic IABP']","['stable hemodynamics', 'conversion, MI and mortality', 'mortality', 'IABP-related mortality or limb ischemia', 'prolonged ventilation in IABP', 'conversion to CPB', 'perioperative MI']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",257.0,0.109726,No significant difference in early outcomes was observed in hemodynamically stable patients with LMD between prophylactic IABP group and control group.,"[{'ForeName': 'Ju-Bing', 'Initials': 'JB', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Hua', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Shao-You', 'Initials': 'SY', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Shi-Jun', 'Initials': 'SJ', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Juan-Juan', 'Initials': 'JJ', 'LastName': 'Sheng', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China. dongran6618@126.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01554-6']
2395,31441525,Effects of a transtheoretical model-based WeChat health education programme on self-management among haemodialysis patients: A longitudinal experimental intervention study.,"AIM
To examine the effects of a transtheoretical model-based WeChat health education programme on self-management in haemodialysis patients in China.
DESIGN
A longitudinal experimental intervention study.
METHODS
Patients (N = 120) who underwent haemodialysis from December 2015-November 2017 were recruited and randomly allocated to either group 1 (who received a 3-month WeChat health education immediately after randomization) or group 2 (who was combined with group 1 and received the same intervention at the 5th month after enrolment in the study). Self-management, knowledge and self-efficacy were assessed at baseline (T 0 ), 3 months after enrolment in the study (T 1 ), 21 months after enrolment in the study (T 2 ).
RESULTS
There were significant group effects on self-efficacy; time effects on partnership, self-care, emotion management with total self-management; interaction effects on problem-solving and emotion management within total self-management according to the two-way repeated measures ANCOVA. Further between-group comparisons indicated that patients in group 1 had better self-management than those in group 2 at T 1 . Within-group comparisons demonstrated that, compared with the baseline values, group 1 had significantly improved self-management at T 1 ; however, group 2 had improved self-management at T 2 .
CONCLUSION
The transtheoretical model-based WeChat health education programme had a potentially positive effect on improving the self-management of haemodialysis patients.
IMPACT
Self-management is often difficult yet crucial for haemodialysis patients. This study indicated that the transtheoretical model-based WeChat health education resulted in improved self-management in haemodialysis patients and can be implemented in continuing care during the interdialysis period to improve self-management in patients.
TRIAL REGISTRATION
ChiCTR1800018172.",2019,"There were significant group effects on self-efficacy; time effects on partnership, self-care, emotion management with total self-management; interaction effects on problem-solving and emotion management within total self-management according to the two-way repeated measures ANCOVA.","['hemodialysis patients', 'hemodialysis patients in China', 'Patients (n=120) who underwent hemodialysis from December 2015 - November 2017']","['3-month WeChat health education immediately after randomization) or group 2 (who was combined with group 1 and received the same intervention', 'transtheoretical model-based WeChat health education', 'transtheoretical model-based WeChat health education program']","['Self-management, knowledge and self-efficacy', 'self-management', 'better self-management', 'self-efficacy; time effects on partnership, self-care, emotion management with total self-management; interaction effects on problem-solving and emotion management within total self-management']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}]",2017.0,0.026199,"There were significant group effects on self-efficacy; time effects on partnership, self-care, emotion management with total self-management; interaction effects on problem-solving and emotion management within total self-management according to the two-way repeated measures ANCOVA.","[{'ForeName': 'Qingli', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'Nursing Department, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Minling', 'Initials': 'M', 'LastName': 'Lian', 'Affiliation': 'Kidney Medical Ward, The First Affiliated Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Nursing Department, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Thomas-Hawkins', 'Affiliation': 'Center for Healthcare Quality, School of Nursing, Rutgers University, Newark, NJ, USA.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Nursing Department, School of Medicine, Xiamen University, Xiamen, China.'}]",Journal of advanced nursing,['10.1111/jan.14182']
2396,32493290,Pre-application of dentin bonding agent prevents discoloration caused by mineral trioxide aggregate.,"BACKGROUND
To evaluate tooth discoloration by newly developed calcium silicate-based materials, and to examine the pre-application of dentin bonding agent (DBA) for preventing discoloration caused by mineral trioxide aggregate (MTA).
METHODS
The roots of 50 premolars were randomly divided into five groups (n = 10) and cavities were prepared from resected root surfaces. MTA was placed in the cavities of teeth belonging to the ProRoot MTA (MTA) and RetroMTA (RMTA) groups. For teeth belonging to the ProRoot + DBA (MTA-B) and RetroMTA + DBA (RMTA-B) groups, DBA was first applied to the cavities prior to the addition of MTA. Teeth in the control group were restored with composite resin only (i.e., without MTA). After 12 weeks, MTA was removed from the MTA and RMTA groups and bleaching agents were applied for 3 additional weeks. Color assessments were recorded at baseline, and 1, 4, and 12 weeks, as well as after bleaching. A one-way ANOVA was performed to assess the differences between the two types of MTAs and color changes following DBA pre-application in each MTA group. A p-value of < 0.05 was considered indicative of statistical significance.
RESULTS
Following 12 weeks of MTA treatment, there was a significant difference between the discoloration in the MTA and RMTA groups (p < 0.05). However, no significant difference was observed between the RMTA and RMTA-B groups (p > 0.05). Following bleaching, the color changes (ΔE values) of the MTA group were not significantly different from those of the MTA-B group (p > 0.05). The difference of ΔE between the RMTA group after internal bleaching and the RMTA-B group was also not significant (p > 0.05).
CONCLUSIONS
RetroMTA caused significantly less discoloration than ProRoot MTA. Pre-application of DBA reduced discoloration caused by ProRoot MTA. MTA discoloration was improved equally well between DBA pre-application and post-bleaching.",2020,"However, no significant difference was observed between the RMTA and RMTA-B groups (p > 0.05).",['50 premolars'],"['MTA', 'RetroMTA']","['discoloration', 'MTA discoloration']","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C4310582', 'cui_str': 'RetroMTA'}]","[{'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}]",50.0,0.0141938,"However, no significant difference was observed between the RMTA and RMTA-B groups (p > 0.05).","[{'ForeName': 'Yoo-Lim', 'Initials': 'YL', 'LastName': 'Choi', 'Affiliation': 'Department of Conservative Dentistry, College of Medicine, Ewha Womans University, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Conservative Dentistry, College of Medicine, Ewha Womans University, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea.'}, {'ForeName': 'Bom Sahn', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine, College of Medicine, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, College of Medicine, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Yemi', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, College of Medicine, Ewha Womans University, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea. yemis@ewha.ac.kr.'}]",BMC oral health,['10.1186/s12903-020-01151-1']
2397,31507250,Using the Personalized Advantage Index for individual treatment allocation to cognitive behavioral therapy (CBT) or a CBT with integrated exposure and emotion-focused elements (CBT-EE).,"Even though different psychotherapeutic interventions for depression have shown to be effective, patients suffering from depression vary substantially in their treatment response. The goal of this study was to answer the following research questions: (1) What are the most important predictors determining optimal treatment allocation to cognitive behavioral therapy (CBT) or CBT with integrated exposure and emotion-focused elements (CBT-EE)?, and (2) Would model-determined treatment allocation using this predictive information result in better treatment outcomes? Bayesian Model Averaging (BMA) was applied to the data of a randomized controlled trial comparing the efficacy of CBT and CBT-EE in depressive outpatients. Predictions were made for every patient for both treatment conditions and an optimal versus a suboptimal treatment was identified in each case. An index comparing the two estimates, the Personalized Advantage Index (PAI), was calculated. Different predictors were found for both conditions. A PAI of 1.35 BDI-II points for the two conditions was found and 46% of the sample was predicted to have a clinically meaningful advantage in one of the therapies. Although the utility of the PAI approach must be further confirmed in prospective research, the present study study promotes the identification of specific interventions favorable for specific patients.",2020,Different predictors were found for both conditions.,['depressive outpatients'],"['cognitive behavioral therapy (CBT', 'CBT and CBT-EE', 'Bayesian Model Averaging (BMA', 'cognitive behavioral therapy (CBT) or CBT with integrated exposure and emotion-focused elements (CBT-EE']",['Personalized Advantage Index (PAI'],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0013879', 'cui_str': 'Elements'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0178449,Different predictors were found for both conditions.,"[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Friedl', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Caspar', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grosse Holtforth', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1664782']
2398,16381354,A randomized comparison of the early outcome of stapled and unstapled techniques of laparoscopic total extraperitoneal inguinal hernia repair.,"OBJECTIVE
The need for stapling is a relative drawback of laparoscopic hernia repairs because it adds to the complications and costs. The safety of unstapled repairs as a viable alternative lacks validation, due to the dearth of analogous comparative trials.
METHODS
Patients were randomized to undergo either stapled or unstapled total extraperitoneal hernia repairs. The groups were matched for age and the type of hernia repaired. Pain scores, intraoperative complications, postoperative complications, postoperative recovery, and long-term outcomes (ie, groin pain, paraesthesias, testicular atrophy, and recurrence) were studied.
RESULTS
The incidence of complications, pain scores, pain trends, hospital stay, return to activity, and long-term outcomes were comparable. No recurrence has been noted at a median follow-up of 23 months in 63 hernias repaired in 49 patients.
CONCLUSION
Unstapled laparoscopic hernia repair scores are equivalent to their stapled counterparts with respect to recurrence and complications.",2005,"No recurrence has been noted at a median follow-up of 23 months in 63 hernias repaired in 49 patients.
",['Patients'],"['stapled or unstapled total extraperitoneal hernia repairs', 'stapled and unstapled techniques', 'laparoscopic total extraperitoneal inguinal hernia repair']","['Pain scores, intraoperative complications, postoperative complications, postoperative recovery, and long-term outcomes (ie, groin pain, paraesthesias, testicular atrophy, and recurrence', 'incidence of complications, pain scores, pain trends, hospital stay, return to activity, and long-term outcomes', 'Unstapled laparoscopic hernia repair scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain (finding)'}, {'cui': 'C0156312', 'cui_str': 'Atrophy of testis (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.251177,"No recurrence has been noted at a median follow-up of 23 months in 63 hernias repaired in 49 patients.
","[{'ForeName': 'Rajinder', 'Initials': 'R', 'LastName': 'Parshad', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India. rparshad@yahoo.com'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Hazrah', 'Affiliation': ''}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Bal', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2399,16381363,"Comparison of 5-, 10-, and 15-point laparoscopic ovarian electrocauterization in patients with polycystic ovarian disease: a prospective, randomized study.","OBJECTIVE
We compared 12-month pregnancy and live birth rates in patients with polycystic ovarian disease undergoing 5-, 10-, and 15-point laparoscopic ovarian electrocauterization.
METHODS
This was a prospective, randomized study performed at the Dabirashrafi Fertility and Endoscopy Research Center, Tehran, Iran. The study included 187 patients with polycystic ovarian disease who were randomly assigned to 3 groups. Group I comprised 67 patients whose ovaries received 5-point electrocauterization. Group II comprised 57 patients whose ovaries received 10-point electrocauterization. Group III comprised 63 patients whose ovaries received 15-point electocauterization. Laparoscopic ovarian electrocauterization with a unipolar current was used. The main outcome measures were 12-month pregnancy and live birth rates.
RESULTS
Patients were homogeneous for age, body mass index, and type and duration of infertility. Twenty pregnancies resulted in Group I, with a pregnancy rate of 29.9% (20/67) and a live birth rate of 20.9% (14/57). Eighteen pregnancies resulted in Group II, with a pregnancy rate of 31.6% (18/57), and a live birth rate of 28.1% (16/57). Thirty-three pregnancies resulted in group III, with a pregnancy rate of 52.4% (33/63), and a live birth rate of 47.6% (30/63). Comparison of Group III with Groups I and II revealed a statistically significant increase in pregnancies (P=0.016) and live birth rates (P=0.004).
CONCLUSION
We recommend 15-point electrocauterization of ovaries in patients with polycystic ovarian disease.",2005,"Comparison of Group III with Groups I and II revealed a statistically significant increase in pregnancies (P=0.016) and live birth rates (P=0.004).
","['187 patients with polycystic ovarian disease', 'Patients were homogeneous for age, body mass index, and type and duration of infertility', 'patients with polycystic ovarian disease', 'patients with polycystic ovarian disease undergoing 5-, 10-, and 15-point laparoscopic ovarian electrocauterization']","['Laparoscopic ovarian electrocauterization', '5-, 10-, and 15-point laparoscopic ovarian electrocauterization']","['pregnancies', 'live birth rate', 'live birth rates', '12-month pregnancy and live birth rates', 'pregnancy rate']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",187.0,0.0750707,"Comparison of Group III with Groups I and II revealed a statistically significant increase in pregnancies (P=0.016) and live birth rates (P=0.004).
","[{'ForeName': 'Nasrin Moghadami', 'Initials': 'NM', 'LastName': 'Tabrizi', 'Affiliation': 'Dabirashrafi Fertility and Endoscopy Research Center Tehran, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Mohammad', 'Affiliation': ''}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Dabirashrafi', 'Affiliation': ''}, {'ForeName': 'Fahime Iravani', 'Initials': 'FI', 'LastName': 'Nia', 'Affiliation': ''}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Salehi', 'Affiliation': ''}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Dabirashrafi', 'Affiliation': ''}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Shams', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2400,16381364,Laparoscopy or laparotomy for the management of endometrial cancer.,"OBJECTIVE
The aim of this study was to evaluate the feasibility of laparoscopy in the management of early stage endometrial cancer.
METHODS
Fifty-two patients with endometrial cancer who underwent surgical staging consisting of total hysterectomy, bilateral salpingo-oophorectomy with pelvic lymph node dissection, and cytology between 1998 to 2002 were included in the study. Laparotomy and laparoscopy were randomly offered to patients upon admittance.
RESULTS
Of 52 patients, 26 underwent laparotomy and the remaining 26 underwent laparoscopic staging surgery. No significant difference existed between the demographic characteristics of the 2 groups. The mean number of harvested lymph nodes was 18.2 in the laparoscopic group and 21.1 in the laparotomic group (P>0.05). Pelvic lymph node metastases were detected in 7.7% of the patients in the laparoscopy group and 15.4% in the laparotomy group, and the difference was not significant. Adjuvant radiotherapy was applied later to 42.3% of the laparoscopy group and 38.5% of the laparotomy group. Operative morbidity was higher in the laparotomy group mainly because of postoperative wound infection, and the patients in the laparotomy group had a longer hospital stay.
CONCLUSION
Laparoscopic surgery is a method that can be applied as well as laparotomy in the management of endometrial cancer. Lymph node number and detection of lymph node metastasis did not differ significantly in laparotomic and laparoscopic approaches. Wound infections were more frequent in laparotomies.",2005,"Pelvic lymph node metastases were detected in 7.7% of the patients in the laparoscopy group and 15.4% in the laparotomy group, and the difference was not significant.","['early stage endometrial cancer', '52 patients, 26 underwent laparotomy and the remaining 26 underwent laparoscopic staging surgery', 'endometrial cancer', 'Fifty-two patients with endometrial cancer who underwent surgical staging consisting of total hysterectomy, bilateral salpingo-oophorectomy with pelvic lymph node dissection, and cytology between 1998 to 2002 were included in the study']","['laparoscopy', 'Laparoscopic surgery', 'Laparotomy and laparoscopy', 'Laparoscopy or laparotomy', 'Adjuvant radiotherapy']","['longer hospital stay', 'mean number of harvested lymph nodes', 'Operative morbidity', 'Pelvic lymph node metastases', 'Wound infections', 'Lymph node number and detection of lymph node metastasis']","[{'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy (procedure)'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}]",52.0,0.0537656,"Pelvic lymph node metastases were detected in 7.7% of the patients in the laparoscopy group and 15.4% in the laparotomy group, and the difference was not significant.","[{'ForeName': 'C Gurkan', 'Initials': 'CG', 'LastName': 'Zorlu', 'Affiliation': 'Akdeniz University School of Medicine, Antalya, Turkey. gurkanzorlu@hotmail.com'}, {'ForeName': 'Tayup', 'Initials': 'T', 'LastName': 'Simsek', 'Affiliation': ''}, {'ForeName': 'Eylem Seker', 'Initials': 'ES', 'LastName': 'Ari', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2401,31513046,Efficacy of the Fluorescein Tear Breakup Time Test in Dry Eye.,"PURPOSE
To examine the effects of volume and method on fluorescein tear breakup time (TBUT) values and to evaluate test efficacy in an independent sample free of selection bias.
METHODS
Subjects were assessed using a battery of dry eye tests (DETs). Efficacy study: Subjects were randomized to the DET, standard strip, and liquid NaFl on separate days. A masked examiner measured TBUTs from video recordings. Verification study: Subjects were investigated for efficacy using volumes of 5.0 and 2.0 μL mL of NaFl for TBUT.
RESULTS
Efficacy study: 46 subjects completed the study. Log-transformed TBUTs were significantly different, normal subjects versus dry subjects, for all 3 methods (all P values < 0.001). Area under the curves (AUCs), cut-points, sensitivity, and specificity were 1) DET: 0.873, 4.4 seconds, 0.97, and 0.67, respectively; 2) 2.0 mL: 0.901, 3.22 seconds, 0.90, and 0.87, respectively; and 3) standard strip: 0.912, 3.42 seconds, 0.97, and 0.80, respectively. Verification study: Data splitting analysis for the 2.0 μL data (n = 174 dry subjects and 97 normal subjects) generated an AUC of 0.917 and a cut-point of 6.05 seconds for a sensitivity of 0.87 and a specificity of 0.81. The 5.0 μL sample yielded an AUC of 0.940, with a sensitivity and specificity of 0.92 and 0.83, respectively, at a cut-point of 5.5 seconds.
CONCLUSIONS
Little difference in TBUT was found using the 3 clinical methods with video recordings. Analysis using liquid NaFl suggests that the TBUT test has excellent diagnostic accuracy and that a cut-point of 5.3 to 6.0 seconds is the optimum to differentiate normals from persons with dry eye.",2020,"Log-transformed TBUTs were significantly different, normal subjects versus dry subjects, for all 3 methods (all P values < 0.001).","['46 subjects completed the study', 'Dry Eye', '2.0 μL data (n = 174 dry subjects and 97 normal subjects', 'Subjects']","['Fluorescein Tear Breakup Time Test', 'DET, standard strip, and liquid NaFl']","['Area under the curves (AUCs), cut-points, sensitivity, and specificity', 'fluorescein tear breakup time (TBUT) values']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0027170', 'cui_str': 'N,-N-diethyltryptamine (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",174.0,0.0428637,"Log-transformed TBUTs were significantly different, normal subjects versus dry subjects, for all 3 methods (all P values < 0.001).","[{'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Paugh', 'Affiliation': 'Southern California College of Optometry at Marshall B. Ketchum University, Fullerton, CA.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Tse', 'Affiliation': 'Private Practice, Hillsboro, OR.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Private Practice, Dover, DE.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sasai', 'Affiliation': 'Southern California College of Optometry at Marshall B. Ketchum University, Fullerton, CA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Southern California College of Optometry at Marshall B. Ketchum University, Fullerton, CA.'}, {'ForeName': 'Melinda Thomas', 'Initials': 'MT', 'LastName': 'De Jesus', 'Affiliation': 'Private Practice, West Covina, CA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Kwan', 'Affiliation': 'Private Practice, Niles, IL.'}, {'ForeName': 'Andrew Loc', 'Initials': 'AL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Mathematics, California State University, Fullerton, CA.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Farid', 'Affiliation': 'Gavin Herbert Eye Institute, University of California, Irvine, CA, and.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Gavin Herbert Eye Institute, University of California, Irvine, CA, and.'}, {'ForeName': 'James V', 'Initials': 'JV', 'LastName': 'Jester', 'Affiliation': 'Gavin Herbert Eye Institute, University of California, Irvine, CA, and.'}]",Cornea,['10.1097/ICO.0000000000002148']
2402,32101857,"Assessment of the Effect of Short-Term Combined High-Intensity Interval Training on TLR4, NF-κB and IRF3 Expression in Young Overweight and Obese Girls.","Obesity is commonly associated with immunometabolic dysfunctions. Activation of inflammatory macrophages through TLR4 (toll-like receptor 4) and the anti-inflammatory impact of exercise have been and are the new concerns among researchers. A new short-term combined high-intensity interval training was proposed in young sedentary overweight/obese females. All participants were allocated to one of two groups: the exercise group (EG) and the control group (CG), where the EG participated in a 2-week combined training and the CG continued its routine lifestyle. Gene expression levels of TLR4, NF-κB(nuclear factor κB), and IRF3 (interferon regulatory factor 3) were assessed by real-time PCR. Physiological, anthropometric, and biomedical metabolic factors were assessed. The between-group comparisons indicated a tendency to a decrease in NF-κB gene expression in the EG. The IRF3 levels were not significantly changed compared to CG and the levels before training. Fasting glucose levels and β-cell function revealed a significant improvement in EG. These findings indicated that this protocol decreased meta-inflammation levels and improved insulin resistance independent of body composition changes. Consequently, combined training may be recommended as a therapeutic approach in metabolic diseases.",2020,"Gene expression levels of TLR4, NF-κB(nuclear factor κB), and IRF3 (interferon regulatory factor 3) were assessed by real-time PCR.","['Young Overweight and Obese Girls', 'young sedentary overweight/obese females']","['exercise group (EG) and the control group (CG', 'combined training and the CG continued its routine lifestyle', 'new short-term combined high-intensity interval training', 'Short-Term Combined High-Intensity Interval Training']","['Fasting glucose levels and β-cell function', 'NF-κB gene expression', 'TLR4, NF-κB and IRF3 Expression', 'Gene expression levels of TLR4, NF-κB(nuclear factor κB), and IRF3 (interferon regulatory factor 3', 'meta-inflammation levels', 'IRF3 levels']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510506', 'cui_str': 'Interferon Regulatory Factor 3'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0128358,"Gene expression levels of TLR4, NF-κB(nuclear factor κB), and IRF3 (interferon regulatory factor 3) were assessed by real-time PCR.","[{'ForeName': 'Nakisa', 'Initials': 'N', 'LastName': 'Soltani', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Esmaeil', 'Affiliation': 'Department of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran, n_esmaeil@med.mui.ac.ir.'}, {'ForeName': 'Sayed Mohammad', 'Initials': 'SM', 'LastName': 'Marandi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Volga', 'Initials': 'V', 'LastName': 'Hovsepian', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Momen', 'Affiliation': 'Department of Allergy and Clinical Immunology, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Noncommunicable Diseases, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Armindokht', 'Initials': 'A', 'LastName': 'Shahsanai', 'Affiliation': 'Department of Community and Family Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kelishadi', 'Affiliation': 'Department of Pediatrics/Child Growth and Development Research Center, Research Institute for Primordial Prevention of Noncommunicable Diseases, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Public health genomics,['10.1159/000506057']
2403,28988765,Results of a Phase 1/2 Study in Metastatic Renal Cell Carcinoma Patients Treated with a Patient-specific Adjuvant Multi-peptide Vaccine after Resection of Metastases.,"Treatment of metastatic renal cell carcinoma comprises metastasectomy±systemic medical treatment. Specific immunotherapy after metastasectomy could be a complementary option. In this phase 1/2 study, safety and tolerability of an adjuvant multi-peptide vaccine (UroRCC) after metastasectomy was evaluated together with immune response and efficacy, compared with a contemporary cohort of patients (n=44) treated with metastasectomy only. Nineteen metastatic renal cell carcinoma patients received UroRCC via intradermal or subcutaneous application randomized to immunoadjuvants (granulocyte-macrophage colony-stimulating factor or Montanide). Adverse events of UroRCC were mainly grade I and II; frequency of immune response was higher for major histocompatibility complex class II peptides (17/19, 89.5%) than for major histocompatibility complex class I peptides (8/19, 42.1%). Median overall survival was not reached in the UroRCC group (mean: 112.6 mo, 95% confidence interval [CI]: 92.1-133.1) and 58.0 mo (95% CI: 32.7-83.2) in the control cohort (p=0.015). UroRCC was an independent prognosticator of overall survival (hazard ratio=0.19, 95% CI: 0.05-0.69, p=0.012). Adjuvant UroRCC multi-peptide vaccine after metastasectomy was well tolerated, immunogenic, and indicates potential clinical benefit when compared with a contemporary control cohort (NCT02429440). PATIENT SUMMARY: The application of a patient-specific peptide vaccine after complete resection of metastases in metastatic renal cell carcinoma patients resulted in favorable tolerability and outcome.",2019,"Adverse events of UroRCC were mainly grade I and II; frequency of immune response was higher for major histocompatibility complex class II peptides (17/19, 89.5%) than for major histocompatibility complex class I peptides (8/19, 42.1%).","['metastatic renal cell carcinoma', 'Metastatic Renal Cell Carcinoma Patients Treated with a Patient-specific Adjuvant Multi-peptide Vaccine after Resection of Metastases', 'Nineteen metastatic renal cell carcinoma patients', 'metastatic renal cell carcinoma patients', 'patients (n=44) treated with metastasectomy only']","['UroRCC', 'UroRCC via intradermal or subcutaneous application randomized to immunoadjuvants (granulocyte-macrophage colony-stimulating factor or Montanide', 'adjuvant multi-peptide vaccine (UroRCC', 'patient-specific peptide vaccine']","['frequency of immune response', 'Median overall survival', 'safety and tolerability', 'overall survival']","[{'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0599934', 'cui_str': 'Vaccines, Peptide'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0001551', 'cui_str': 'Immunoactivators'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0599934', 'cui_str': 'Vaccines, Peptide'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.175504,"Adverse events of UroRCC were mainly grade I and II; frequency of immune response was higher for major histocompatibility complex class II peptides (17/19, 89.5%) than for major histocompatibility complex class I peptides (8/19, 42.1%).","[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Rausch', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Gouttefangeas', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hennenlotter', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Laske', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Walter', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Premachandran Anoop', 'Initials': 'PA', 'LastName': 'Chandran', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kruck', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh-Jasuja', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Frick', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kröger', 'Affiliation': 'Department of Urology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Stevanović', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Rammensee', 'Affiliation': 'Department of Immunology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: jens.bedke@med.uni-tuebingen.de.'}]",European urology focus,['10.1016/j.euf.2017.09.009']
2404,15554283,Evaluation of operative imaging techniques in surgical education.,"BACKGROUND
Certain open surgical procedures are difficult to observe, and poor visualization of the surgical field results in a compromised teaching environment for residents and medical students. In an attempt to improve the visualization of the open surgical field, we performed an open surgical procedure while viewing it via a laparoscope mounted to the side of the operating room table with an alpha port. These images were then compared in a blinded fashion with images from a boom-mounted camera positioned above the surgical field and a head-mounted camera positioned on the operating surgeon.
METHODS
Participants viewed all 3 images from a remote location in a blinded, random fashion. All participants then completed a Likert questionnaire evaluating each image.
RESULTS
Fourteen participants were in the study. The alpha port/laparoscope image was superior to the head-cam image in all 8 categories. The alpha port/laparoscope image was superior to the sky-cam image in 4 of 8 categories. All 14 participants felt the alpha port/laparoscope image would benefit surgical education
CONCLUSIONS
Use of a laparoscope mounted via an alpha port to an operating room table provides superior images during open surgery. This provides a unique and affordable way to teach residents and medical students operative procedures that are otherwise difficult to view.",2004,"All 14 participants felt the alpha port/laparoscope image would benefit surgical education
CONCLUSIONS
Use of a laparoscope mounted via an alpha port to an operating room table provides superior images during open surgery.","['Fourteen participants were in the study', 'residents and medical students', 'Participants viewed all 3 images from a remote location in a blinded, random fashion', 'surgical education']",[],[],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],[],14.0,0.0160656,"All 14 participants felt the alpha port/laparoscope image would benefit surgical education
CONCLUSIONS
Use of a laparoscope mounted via an alpha port to an operating room table provides superior images during open surgery.","[{'ForeName': 'Shanu N', 'Initials': 'SN', 'LastName': 'Kothari', 'Affiliation': 'Department of Surgery and Center for Minimally Invasive Surgery, Medical College of Virginia Campus of Virginia Commonwealth University, Richmond, Virginia 23298, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Broderick', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'DeMaria', 'Affiliation': ''}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Merrell', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2405,31512550,The effects of a sleep/recovery supplement: 'Night Time Recharge' on sleep parameters in young adults.,"BACKGROUND
Concentrated cherry juice reportedly contains melatonin which, in turn, has been highlighted as an important regulator in initiating sleep.
AIM
The present investigation aims to clarify whether Night Time Recharge (NTR), a marketed sleep aid containing cherry extract, improves key sleep parameters in young, active adults with mildly poor sleep.
METHODS
A double-blind, randomized, placebo-controlled, cross-over study design was employed. Twenty participants (nine female) consumed either NTR or a placebo for seven days. Accelerometers were used to assess sleep quality and physical activity levels. Urinary levels of 6-sulphatoxymelatonin (6-SMT), a marker of melatonin synthesis, was assessed via enzyme-linked immunosorbent assay.
RESULTS
6-SMT levels increased following NTR treatment (28.95 ng/ml) compared with placebo (4.0 ng/ml) ( p < 0.001). There was also a significant difference ( p = 0.047) in dietary tryptophan consumption during the NTR treatment (1236 mg) versus placebo (1149 mg). No trace of melatonin was detected from our analysis of the supplement. NTR had no significant effect on any sleep parameters with the exception of sleep latency ( p = 0.001).
CONCLUSIONS
As chemical analysis of NTR by liquid-chromatography mass-spectrometry identified no detectable melatonin, the tryptophan content of the supplement is a likely reason for improvement in sleep latency. These results are in contrast to previous studies which have found a positive effect on sleep following cherry supplementation. Future work should focus on sleep latency and investigating whether cherry juice is effective in participants with problems in initiating sleep.",2019,"NTR had no significant effect on any sleep parameters with the exception of sleep latency ( p = 0.001).
","['young adults', 'Twenty participants (nine female', 'young, active adults with mildly poor sleep', 'participants with problems in initiating sleep']","['placebo', 'Night Time Recharge (NTR', 'NTR or a placebo', ""sleep/recovery supplement: 'Night Time Recharge""]","['dietary tryptophan consumption', 'Urinary levels of 6-sulphatoxymelatonin (6-SMT), a marker of melatonin synthesis', 'sleep latency', 'sleep quality and physical activity levels', 'sleep parameters', '6-SMT levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0049713', 'cui_str': '6-hydroxymelatoninsulfate'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",20.0,0.236778,"NTR had no significant effect on any sleep parameters with the exception of sleep latency ( p = 0.001).
","[{'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Simper', 'Affiliation': 'Food and Nutrition group, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Gilmartin', 'Affiliation': 'Food and Nutrition group, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Allwood', 'Affiliation': 'Department of Biosciences and Chemistry, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'School of Pharmacy and Life Science, Robert Gordon University, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chappell', 'Affiliation': 'School of Pharmacy and Life Science, Robert Gordon University, Aberdeen, UK.'}]",Nutrition and health,['10.1177/0260106019875911']
2406,32433165,Effect of Different 131I Dose Strategies for Treatment of Hyperthyroidism on Graves' Ophthalmopathy.,"PURPOSE
The study aims to define the effect of different dose strategies on ophthalmic complications in patients with Graves' disease (GD).
METHODS
All the patients with GD and no or inactive ophthalmopathy (clinical activity score; CAS < 3) underwent Snellen chart examination, measurement of proptosis, thyroid volume, and radioactive iodine uptake, and randomized into 1 of 3 groups. In group 1, all the patients received fixed low dose (FLD) of 259 MBq of I, whereas in group 2, all the patients received fixed high dose (FHD) of 555 MBq, and in group 3, calculated dose (CD) was administered to deliver 5.55 MBq/g (thyroid weight) of I. All examinations were repeated 6 months after treatment. The measurement of thyroid function tests and clinical examination were repeated after 12 months.
RESULTS
We studied 92 patients (58 female and 34 male) with mean age of 38.2 ± 12.0 years. Overall, 29, 32, and 31 patients were studied in FLD, FHD, and CD groups, respectively. The patients in CD received a mean activity of 240.5 MBq. The 3 groups were not significantly different regarding age, sex ratio, radioactive iodine uptake, smoking, visual acuity, and proptosis. The response rate 12 months after radioactive iodine therapy was 66.7%, 94.4%, and 92.9% in FLD, FHD, and CD groups, respectively (P = 0.05). Overall, CAS was increased significantly after treatment. Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05). The highest increment in proptosis was seen in FHD group.
CONCLUSIONS
The administration of 5.55 MBq/g of I has fewer ophthalmic complications compared with high fixed dose model and is more effective than low fixed dose strategy.",2020,Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05).,"['92 patients (58 female and 34 male) with mean age of 38.2 ± 12.0 years', ""patients with Graves' disease (GD""]",['radioactive iodine therapy'],"['Delta proptosis and delta CAS', 'response rate', 'ophthalmic complications', 'age, sex ratio, radioactive iodine uptake, smoking, visual acuity, and proptosis', 'CAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0203610', 'cui_str': 'Teleradiotherapy with iodine-125'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0015300', 'cui_str': 'Exophthalmos'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C0203778', 'cui_str': 'Radionuclide imaging of thyroid using iodine radioisotope'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",92.0,0.0359855,Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05).,"[{'ForeName': 'Shahrara', 'Initials': 'S', 'LastName': 'Ariamanesh', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Narjess', 'Initials': 'N', 'LastName': 'Ayati', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mazloum Khorasani', 'Affiliation': 'Metabolic Syndrome Research Center.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mousavi', 'Affiliation': 'Metabolic Syndrome Research Center.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Kiavash', 'Affiliation': 'Ophthalmology Department, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kiamanesh', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Seyed Rasoul', 'Initials': 'SR', 'LastName': 'Zakavi', 'Affiliation': 'From the Nuclear Medicine Research Center.'}]",Clinical nuclear medicine,['10.1097/RLU.0000000000003086']
2407,31507265,"Promoting vaccination in maternity wards ─ motivational interview technique reduces hesitancy and enhances intention to vaccinate, results from a multicentre non-controlled pre- and post-intervention RCT-nested study, Quebec, March 2014 to February 2015.","BackgroundMany countries are grappling with growing numbers of parents who delay or refuse recommended vaccinations for their children. This has created a need for strategies to address vaccine hesitancy (VH) and better support parental decision-making regarding vaccination.AimTo assess vaccination intention (VI) and VH among parents who received an individual motivational-interview (MI) based intervention on infant immunisation during post-partum stay at a maternity ward between March 2014 and February 2015.MethodsThis non-controlled pre-/post-intervention study was conducted using the results from parents enrolled in the intervention arm of the PromoVaQ randomised control trial (RCT), which was conducted in four maternity wards across the Province of Quebec. Participants (n = 1,223) completed pre- and post-intervention questionnaires on VI and VH using Opel's score. Pre-/post-intervention measures were compared using McNemar's test for categorical variables and Wilcoxon signed-rank test for continuous variables.ResultsPre-intervention: overall VI was 78% and significantly differed across maternity wards (74%, 77%, 84%, 79%, p = 0.02). Post-intervention: VI rose significantly across maternity wards (89%, 85%, 95%, 93%) and the overall increase in VI was 12% (78% vs 90%, p < 0.0001). VH corroborated these observations, pre- vs post-intervention, for each maternity ward (28% vs 16%, 29% vs 21%, 27% vs 17%, 24% vs 13%). Overall, VH was curbed post-intervention by 40% (27% vs 16%; p < 0.0001).ConclusionsCompared with pre-intervention status, participants who received the MI-based intervention on immunisation displayed lower hesitancy and greater intention to vaccinate their infant at 2 months of age.",2019,"Overall, VH was curbed post-intervention by 40% (27% vs 16%; p < 0.0001).ConclusionsCompared with pre-intervention status, participants who received the MI-based intervention on immunisation displayed lower hesitancy and greater intention to vaccinate their infant at 2 months of age.","['parents who received an', 'Participants (n\u2009=\u20091,223) completed', 'parents enrolled in the intervention arm of the PromoVaQ randomised control trial (RCT), which was conducted in four maternity wards across the Province of Quebec']","['Post-intervention', 'individual motivational-interview (MI) based intervention on infant immunisation during post-partum stay at a maternity ward between March 2014 and February 2015.MethodsThis non-controlled pre-/post-intervention', ""pre- and post-intervention questionnaires on VI and VH using Opel's score""]",[],"[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",[],,0.133223,"Overall, VH was curbed post-intervention by 40% (27% vs 16%; p < 0.0001).ConclusionsCompared with pre-intervention status, participants who received the MI-based intervention on immunisation displayed lower hesitancy and greater intention to vaccinate their infant at 2 months of age.","[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gagneur', 'Affiliation': 'Centre hospitalier universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Battista', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'François D', 'Initials': 'FD', 'LastName': 'Boucher', 'Affiliation': 'Centre de recherche du Centre Hospitalier Universitaire de Québec, Québec, Québec, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Tapiero', 'Affiliation': 'CHU Sainte Justine, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Quach', 'Affiliation': 'McGill University Health Centre Research Institute - Vaccine Study Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'De Wals', 'Affiliation': 'Department of Social and Preventive Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lemaitre', 'Affiliation': 'Centre de recherche du CHUS, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Farrands', 'Affiliation': 'Centre de recherche du CHUS, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Boulianne', 'Affiliation': 'Institut national de santé publique du Québec, Québec, Québec, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Sauvageau', 'Affiliation': 'Institut national de santé publique du Québec, Québec, Québec, Canada.'}, {'ForeName': 'Manale', 'Initials': 'M', 'LastName': 'Ouakki', 'Affiliation': 'Institut national de santé publique du Québec, Québec, Québec, Canada.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Gosselin', 'Affiliation': 'Centre de recherche du CHUS, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Petit', 'Affiliation': ""Direction de santé publique du CIUSSS de l'Estrie - CHUS, Département des sciences de la santé communautaire, Université de Sherbrooke, Sherbrooke, Québec, Canada.""}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Jacques', 'Affiliation': ""Institut universitaire de première ligne en santé et services sociaux du CIUSSS de l'Estrie - CHUS, Québec, Canada.""}, {'ForeName': 'Ève', 'Initials': 'È', 'LastName': 'Dubé', 'Affiliation': 'Institut national de santé publique du Québec, Québec, Québec, Canada.'}]",Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin,['10.2807/1560-7917.ES.2019.24.36.1800641']
2408,15347114,Evaluation of fundus-first laparoscopic cholecystectomy.,"OBJECTIVES
Laparoscopic cholecystectomy is the gold standard for gallbladder surgery. Cholecystectomy from the fundus to the cystic duct may be advantageous when cystic duct exposure becomes difficult due to adhesions on Calot's triangle. The aim of this study was to compare conventional laparoscopic cholecystectomy with the fundus-first procedure and to evaluate whether the fundus-first technique can prevent conversion in difficult cases.
METHODS
The study included 145 patients treated over 18 months. The inclusion criterion was the presence of ultrasound proven gallstones. Patients were excluded from the study if there was evidence of common bile duct stones, a bilioenteric fistula, or carcinoma of the gallbladder.
RESULTS
The fundus-first approach was started in 45 patients; all procedures were completed laparoscopically. Conventional laparoscopic cholecystectomy was begun in 100 patients. Twenty-seven of the 100 patients were converted to fundus dissection (adhesions within Calot's triangle). Four of the 27 were further converted to open surgery. One patient had a drop in blood pressure on creation of pneumoperitoneum. Time taken for severely inflammatory and noninflammatory cases was significantly greater (P<0.05) in the fundus-first group. The average hospital stay was 48 hours in both groups. No major complications were observed.
CONCLUSION
The rate of conversion in the conventional laparoscopic cholecystectomy group decreased from 18.75% (27/144) to 2.08% (3/144). The fundus-first technique has the potential to decrease conversion in difficult cases.",2004,Time taken for severely inflammatory and noninflammatory cases was significantly greater (P<0.05) in the fundus-first group.,"['145 patients treated over 18 months', ""Twenty-seven of the 100 patients were converted to fundus dissection (adhesions within Calot's triangle"", 'Patients were excluded from the study if there was evidence of common bile duct stones, a bilioenteric fistula, or carcinoma of the gallbladder', '100 patients']","['fundus-first laparoscopic cholecystectomy', 'Laparoscopic cholecystectomy', 'Conventional laparoscopic cholecystectomy', 'conventional laparoscopic cholecystectomy']","['average hospital stay', 'rate of conversion', 'blood pressure on creation of pneumoperitoneum']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0205119', 'cui_str': 'Triangular (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009438', 'cui_str': 'Common Bile Duct Gall Stones'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder'}]","[{'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}]",145.0,0.0162921,Time taken for severely inflammatory and noninflammatory cases was significantly greater (P<0.05) in the fundus-first group.,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, Delhi, India. amitgupta76@hotmail.com'}, {'ForeName': 'Prem Narayan', 'Initials': 'PN', 'LastName': 'Agarwal', 'Affiliation': ''}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Kant', 'Affiliation': ''}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Malik', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2409,32040960,"Poxvirus Vectored Cytomegalovirus Vaccine to Prevent Cytomegalovirus Viremia in Transplant Recipients: A Phase 2, Randomized Clinical Trial.","Background
Triplex vaccine was developed to enhance cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation early after hematopoietic stem cell transplant (HCT).
Objective
To determine the safety and efficacy of Triplex.
Design
First-in-patient, phase 2 trial. (ClinicalTrials.gov: NCT02506933).
Setting
3 U.S. HCT centers.
Participants
102 CMV-seropositive HCT recipients at high risk for CMV reactivation.
Intervention
Intramuscular injections of Triplex or placebo were given on days 28 and 56 after HCT. Triplex is a recombinant attenuated poxvirus (modified vaccinia Ankara) expressing immunodominant CMV antigens.
Measurements
The primary outcomes were CMV events (CMV DNA level ≥1250 IU/mL, CMV viremia requiring antiviral treatment, or end-organ disease), nonrelapse mortality, and severe (grade 3 or 4) graft-versus-host disease (GVHD), all evaluated through 100 days after HCT, and grade 3 or 4 adverse events (AEs) within 2 weeks after vaccination that were probably or definitely attributable to injection.
Results
A total of 102 patients (51 per group) received the first vaccination, and 91 (89.2%) received both vaccinations (46 Triplex and 45 placebo). Reactivation of CMV occurred in 5 Triplex (9.8%) and 10 placebo (19.6%) recipients (hazard ratio, 0.46 [95% CI, 0.16 to 1.4]; P = 0.075). No Triplex recipient died of nonrelapse causes during the first 100 days or had serious AEs, and no grade 3 or 4 AEs related to vaccination were observed within 2 weeks after vaccination. Incidence of severe acute GVHD after injection was similar between groups (hazard ratio, 1.1 [CI, 0.53 to 2.4]; P = 0.23). Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
Limitation
The lower-than-expected incidence of CMV events in the placebo group reduced the power of the trial.
Conclusion
No vaccine-associated safety concerns were identified. Triplex elicited and amplified CMV-specific immune responses, and fewer Triplex-vaccinated patients had CMV viremia.
Primary Funding Source
National Cancer Institute and Helocyte.",2020,"Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
","['≥1250', 'Participants\n\n\n102 CMV-seropositive HCT recipients at high risk for CMV reactivation', 'Transplant Recipients', '102 patients (51 per group) received the first vaccination, and 91 (89.2%) received']","['Poxvirus Vectored Cytomegalovirus Vaccine', 'placebo', 'Triplex or placebo', 'both vaccinations (46 Triplex and 45 placebo']","['Cytomegalovirus Viremia', 'CMV events (CMV DNA level', 'Incidence of severe acute GVHD', 'Levels of long-lasting, pp65-specific T cells with effector memory phenotype', 'nonrelapse mortality, and severe (grade 3 or 4) graft-versus-host disease (GVHD', 'CMV events', 'cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation', 'Triplex elicited and amplified CMV-specific immune responses', 'Reactivation of CMV']","[{'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0032868', 'cui_str': 'Poxviruses'}, {'cui': 'C0887903', 'cui_str': 'Cytomegalovirus Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877635', 'cui_str': 'Cytomegalovirus viremia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C4543203', 'cui_str': 'Effector (disposition)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",102.0,0.529622,"Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Aldoss', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'La Rosa', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts (L.R.B., N.C.I.).""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Longmate', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Ella J', 'Initials': 'EJ', 'LastName': 'Ariza-Heredia', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas (E.J.A.).'}, {'ForeName': 'Wasima N', 'Initials': 'WN', 'LastName': 'Rida', 'Affiliation': 'Biostatistics Consultant, Arlington, Virginia (W.N.R.).'}, {'ForeName': 'Chetan Raj', 'Initials': 'CR', 'LastName': 'Lingaraju', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Kaltcheva', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Dagis', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Hardwick', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Nicolas C', 'Initials': 'NC', 'LastName': 'Issa', 'Affiliation': ""Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts (L.R.B., N.C.I.).""}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Farol', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Auayporn', 'Initials': 'A', 'LastName': 'Nademanee', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Monzr M', 'Initials': 'MM', 'LastName': 'Al Malki', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Don J', 'Initials': 'DJ', 'LastName': 'Diamond', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2511']
2410,15791969,Endoscope-assisted inguinal hernia repair.,"BACKGROUND
Since the advent of laparoscopic inguinal hernia repair, the procedure has invited numerous controversies, and although the procedure has some definitive advantages, no definitive indications for its use have been formulated. The objective of this study was to investigate a novel method for inguinal hernia repair (through a small 2 cm to 2.5 cm) single skin incision that combines the time-tested fundamentals of Lichtenstein's tension-free repair with the advantages of laparoscopic assistance.
METHODS
The study was conducted as a randomized, controlled trial over a 1-year period and included 50 patients. Only patients with simple reducible hernias without associated comorbid conditions were included. The patients were randomized into 2 groups of 25 patients each. One group underwent conventional tension-free meshplasty, while the other group underwent the repair through a single 2-cm to 2.5-cm skin incision with laparoscopic assistance. This repair was carried out with the help of an indigenously designed steel retractor, 10-mm laparoscope, and conventional instruments; the mesh was fixed with the help of endotacks. Univariate analysis of variance techniques using SPSS 7.5 software was used for data analysis.
RESULTS
Two groups were compared for time taken for the procedure, size of skin incision, postoperative pain, complications, return to work, and cosmetic appearance. The results showed a significant decrease in postoperative pain and an earlier return to work, along with much improved cosmesis for the new procedure.
CONCLUSIONS
Although the study was conducted with a limited number of patients and a very short follow-up, it is worth considering this method over laparoscopic and conventional techniques, especially in reducible hernias.",2005,"RESULTS
Two groups were compared for time taken for the procedure, size of skin incision, postoperative pain, complications, return to work, and cosmetic appearance.","['50 patients', 'Only patients with simple reducible hernias without associated comorbid conditions were included']","['Endoscope-assisted inguinal hernia repair', 'conventional tension-free meshplasty, while the other group underwent the repair through a single 2-cm to 2.5-cm skin incision with laparoscopic assistance', ""inguinal hernia repair (through a small 2 cm to 2.5 cm) single skin incision that combines the time-tested fundamentals of Lichtenstein's tension-free repair""]","['time taken for the procedure, size of skin incision, postoperative pain, complications, return to work, and cosmetic appearance', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0205337', 'cui_str': 'Reducible (qualifier value)'}, {'cui': 'C1275743', 'cui_str': 'Comorbid conditions'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]",50.0,0.0776127,"RESULTS
Two groups were compared for time taken for the procedure, size of skin incision, postoperative pain, complications, return to work, and cosmetic appearance.","[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Department of Surgery, Lady Hardinge Medical College and Associated Hospitals, New Delhi, India. chawlasaurabh@yahoo.co.in'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Lal', 'Affiliation': ''}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Ganguly', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Arora', 'Affiliation': ''}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Hadke', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2411,31800067,Association of β-Blocker Use With Heart Failure Hospitalizations and Cardiovascular Disease Mortality Among Patients With Heart Failure With a Preserved Ejection Fraction: A Secondary Analysis of the TOPCAT Trial.,"Importance
β-Blockers are prescribed to most patients with heart failure (HF) with a preserved ejection fraction (HFpEF), but their effect on HFpEF remains unclear.
Objective
To determine the association of β-blocker use with HF hospitalizations and cardiovascular disease (CVD) mortality, overall and in strata of patients with an ejection fraction (EF) of 50% or greater or less than 50%.
Design, Setting, and Participants
For 1761 participants from North and South America enrolled in the multicenter, double-blinded Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist randomized clinical trial of spironolactone for patients with HFpEF between August 10, 2006, and January 31, 2012, the association of baseline β-blocker use with HF hospitalization and CVD mortality was analyzed using unadjusted and adjusted Cox proportional hazards regression models, overall and in strata of patients with an EF of 50% or greater or less than 50%. Participants had symptomatic HF with a left ventricular EF of 45% or greater, with enrollment based on either hospitalization attributed to decompensated HF in the prior year or elevated natriuretic peptide levels. Statistical analysis was performed from January 31 to May 2, 2019.
Exposure
Use of β-blockers.
Main Outcomes and Measures
Incident HF hospitalization and CVD mortality.
Results
Among 1761 participants included in the analysis (879 women and 882 men; mean [SD] age, 71.5 [9.6] years), 1394 (79.2%) reported β-blocker use and 1567 (89.0%) had an EF of 50% or greater. Hospitalizations for HF occurred for 399 participants (22.7%), and CVD mortality occurred for 229 participants (13.0%). Use of β-blockers was associated with a higher risk of HF hospitalization among patients with HFpEF with an EF of 50% or greater (hazard ratio, 1.74 [95% CI, 1.28-2.37]; P < .001) but not among patients with an EF between 45% and 49% (hazard ratio, 0.68 [95% CI, 0.28-1.63]; P = .39). There was a significant interaction between β-blocker use and EF threshold for incident HF hospitalizations (P = .03). Use of β-blockers was not associated with a change in CVD mortality.
Conclusions and Relevance
For patients with an EF of 50% or greater, β-blocker use was associated with an increased risk of HF hospitalizations but not CVD mortality. For patients with an EF between 45% and 49%, there was no such association.",2019,There was a significant interaction between β-blocker use and EF threshold for incident HF hospitalizations (P = .03).,"['patients with an ejection fraction (EF) of 50% or greater or less than 50', 'Patients With Heart Failure', '1761 participants included in the analysis (879 women and 882 men; mean [SD] age, 71.5 [9.6] years), 1394 (79.2%) reported β-blocker use and 1567 (89.0%) had an EF of 50% or greater', 'Participants had symptomatic HF with a left ventricular EF of 45% or greater, with enrollment based on either hospitalization attributed to decompensated HF in the prior year or elevated natriuretic peptide levels', 'patients with an EF of 50% or greater or less than 50', '1761 participants from North and South America enrolled in the multicenter, double-blinded Treatment of Preserved Cardiac Function Heart Failure with an', 'patients with heart failure (HF) with a preserved ejection fraction (HFpEF']","['Aldosterone Antagonist', 'Preserved Ejection Fraction', 'spironolactone']","['Cardiovascular Disease Mortality', 'HF hospitalizations and cardiovascular disease (CVD) mortality', 'Measures\n\n\nIncident HF hospitalization and CVD mortality', 'risk of HF hospitalizations', 'HF hospitalization and CVD mortality', 'higher risk of HF hospitalization', 'Hospitalizations for HF', 'CVD mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]",1761.0,0.150451,There was a significant interaction between β-blocker use and EF threshold for incident HF hospitalizations (P = .03).,"[{'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Silverman', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Infeld', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Callas', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Geoff B', 'Initials': 'GB', 'LastName': 'Dougherty', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.16598']
2412,31509210,Effect of MyTeen SMS-Based Mobile Intervention for Parents of Adolescents: A Randomized Clinical Trial.,"Importance
There is global pressure to respond to the burden posed by adolescent mental health problems. The National Mental Health Commission has made a call for investment in mobile health services directed at prevention and early intervention to relieve the demand on targeted mental health services that are costly to provide. Parents and primary caregivers play a significant role in the lives of adolescents and are important targets for such efforts. Currently, there is no evidence for the effectiveness of programs delivered solely via text message for parents of adolescents.
Objective
To evaluate the effects of a text-messaging program (MyTeen) on promoting parental competence and mental health literacy for parents of adolescents.
Design, Setting, and Participants
A parallel 2-group randomized clinical trial was conducted in New Zealand. A total of 221 parents and primary caregivers of adolescents aged 10 to 15 years were recruited from March 19 to August 17, 2018, via community outreach and social media and were randomly allocated 1:1 into the control or the intervention group. Statistical analysis was performed on the principle of intention to treat with adjustment for baseline factors and ethnicity.
Intervention
A text-messaging program for parents of adolescents (age 10-15 years) to promote parental competence and mental health literacy. Participants received 1 daily text message over 4 weeks.
Main Outcomes and Measures
Parental competence, assessed at 1 month after randomization by the Parenting Sense of Competence Scale.
Results
In total, 221 participants (214 [96.8%] female) were randomized, 109 to the intervention group and 112 to the control group; 201 participants (91%) completed the trial at 3 months. Significant group difference was observed on the primary outcome at the end of 1 month of intervention, with participants reporting a higher level of parental competence than those in the control group (estimated mean difference, 3.33 points; 95% CI, 1.37-5.29 points; P = .002). Except for knowledge about mental health, all secondary outcomes were significant, including continued improvement in parental competence at 3 months (estimated mean difference, 4.08 points; 95% CI, 1.96-6.20 points; P < .001), knowledge of help seeking (estimated mean difference, 0.99 points; 95% CI, 0.49-1.50 points; P < .001), parental distress (estimated mean difference, -2.39 points; 95% CI, -4.37 to -0.40 points; P = .02), and parent-adolescent communication (estimated mean difference, 2.21 points; 95% CI, 0.48-3.95 points; P = .01), with participants in the intervention group reporting better parenting-related outcomes than the control group at 1 and 3 months after the intervention.
Conclusions and Relevance
This text-messaging program for parents of adolescents appears to be an effective and feasible way to facilitate the implementation and delivery of evidence-based information to populations that are not easily reached with other intervention modalities. The program can be easily scaled up for delivery as an early preventive intervention and may represent a less expensive option for service delivery.
Trial Registration
anzctr.org.au Identifier: ACTRN12618000117213.",2019,A text-messaging program for parents of adolescents (age 10-15 years) to promote parental competence and mental health literacy.,"['parents of adolescents', 'parents of adolescents (age 10-15 years) to promote parental competence and mental health literacy', '221 participants (214 [96.8%] female) were randomized, 109 to the intervention group and 112 to the control group; 201 participants (91%) completed the trial at 3 months', 'Parents of Adolescents', '221 parents and primary caregivers of adolescents aged 10 to 15 years were recruited from March 19 to August 17, 2018, via community outreach and social media']","['MyTeen SMS-Based Mobile Intervention', 'text-messaging program (MyTeen']","['level of parental competence', 'knowledge of help seeking', 'Parenting Sense of Competence Scale', 'parental distress', 'parental competence and mental health literacy', 'parent-adolescent communication', 'parental competence']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0222045'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",221.0,0.227912,A text-messaging program for parents of adolescents (age 10-15 years) to promote parental competence and mental health literacy.,"[{'ForeName': 'Joanna Ting Wai', 'Initials': 'JTW', 'LastName': 'Chu', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wadham', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Stasiak', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Shepherd', 'Affiliation': 'School of Psychology, Massey University, Auckland, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'The National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11120']
2413,16121879,Intraperitoneal and intravenous routes for pain relief in laparoscopic cholecystectomy.,"BACKGROUND
Postoperative abdominal and shoulder pain are the most common complaints after elective laparoscopic cholecystectomy. Postoperative pain is multifactorial in origin, and therefore multimodal therapy may be needed to optimize pain relief.
METHODS
We conducted a double-blind study where patients were randomly allocated to 1 of 5 groups of 20 patients each. Statistical significance was considered P<0.05. Group 1 received 40 mL bupivacaine 0.25% intraperitoneal spray. Group 2 received 40 mL bupivacaine 0.25% intraperitoneal spray mixed with 200 mg ketoprofen. Group 3 received 40 mL bupivacaine 0.25% intraperitoneal spray and intravenous 200 mg ketoprofen. Group 4 received 200 mg ketoprofen intravenously. Group 5 was the control group.
RESULTS
Demographic data were similar in the 5 groups. As compared with the control group, group 1 had significantly lower abdominal pain scores at 6 hours; group 2 at 0, 1, 2, and 6 hours; group 3 at 0, 1, 2, 6, 12, and 24 hours; and group 4 at 2 hours. Group 1 had significantly lower shoulder pain scores at 1 and 6 hours; group 2 at 0 and 6 hours; and groups 3 and 4 at 0, 1, and 6 hours. The number of patients requiring postoperative rescue analgesics and the incidence of postoperative vomiting were significantly lower in group 3 only.
CONCLUSIONS
A multimodal approach to pain management following elective laparoscopic cholecystectomy is best achieved with a combination of 40 mL bupivacaine 0.25% intraperitoneal spray and 200 mg intravenous ketoprofen, achieving the least incidence of postoperative vomiting.",2005,"Group 1 had significantly lower shoulder pain scores at 1 and 6 hours; group 2 at 0 and 6 hours; and groups 3 and 4 at 0, 1, and 6 hours.","['laparoscopic cholecystectomy', 'patients were randomly allocated to 1 of 5 groups of 20 patients each']","['40 mL bupivacaine 0.25% intraperitoneal spray mixed with 200 mg ketoprofen', 'ketoprofen', '40 mL bupivacaine 0.25% intraperitoneal spray and intravenous 200 mg ketoprofen', 'elective laparoscopic cholecystectomy', '40 mL bupivacaine 0.25% intraperitoneal spray', 'bupivacaine', 'Intraperitoneal and intravenous routes']","['number of patients requiring postoperative rescue analgesics and the incidence of postoperative vomiting', 'abdominal pain scores', 'pain relief', 'postoperative vomiting', 'shoulder pain scores']","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C1522726', 'cui_str': 'IV use'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520905', 'cui_str': 'Postoperative Emesis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]",,0.0295053,"Group 1 had significantly lower shoulder pain scores at 1 and 6 hours; group 2 at 0 and 6 hours; and groups 3 and 4 at 0, 1, and 6 hours.","[{'ForeName': 'Samar I', 'Initials': 'SI', 'LastName': 'Jabbour-Khoury', 'Affiliation': 'Department of Anesthesiology and Surgery, American University of Beirut-Medical Center, Beirut, Lebanon. gkhoury02@hotmail.com'}, {'ForeName': 'Aliya S', 'Initials': 'AS', 'LastName': 'Dabbous', 'Affiliation': ''}, {'ForeName': 'Frederic J', 'Initials': 'FJ', 'LastName': 'Gerges', 'Affiliation': ''}, {'ForeName': 'Mireille S', 'Initials': 'MS', 'LastName': 'Azar', 'Affiliation': ''}, {'ForeName': 'Chakib M', 'Initials': 'CM', 'LastName': 'Ayoub', 'Affiliation': ''}, {'ForeName': 'Ghattas S', 'Initials': 'GS', 'LastName': 'Khoury', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2414,32102058,Hypoxic Exercise Training to Improve Exercise Capacity in Obese Individuals.,"INTRODUCTION
Combining exercise training with hypoxic exposure has been recently proposed as a new therapeutic strategy to improve health status of obese individuals. Whether hypoxic exercise training (HET) provides greater benefits regarding body composition and cardiometabolic parameters than normoxic exercise training (NET) remains however unclear. We hypothesized that HET would induce greater improvement in exercise capacity and health status than NET in overweight and obese individuals.
METHODS
Twenty-three subjects were randomized into 8-week HET (11 males and 1 female ; age: 52 ± 12 years ; BMI: 31.2 ± 2.4 kg·m) or NET (8 males and 3 females ; age: 56 ± 11 years ; BMI: 31.8 ± 3.2 kg·m) programs (3 sessions/week; constant-load cycling at 75% of maximal heart rate; target arterial oxygen saturation for HET 80%, FiO2 ~0.13, i.e. ~3700 m a.s.l.). Before and after the training programs, the following evaluations were performed: incremental maximal and submaximal cycling tests, measurements of pulse-wave velocity, endothelial function, fasting glucose, insulin and lipid profile, blood NO metabolites and oxidative stress, determination of body composition by magnetic resonance imaging.
RESULTS
Peak oxygen consumption and maximal power output increased significantly after HET only (peak oxygen consumption HET + 10 ± 11% versus NET + 1 ± 10% and maximal power output HET + 11 ± 7% versus NET + 3 ± 10%, p < 0.05). Submaximal exercise responses improved similarly after HET and NET. Except diastolic blood pressure which decreased significantly after both HET and NET, no change in vascular function, metabolic status and body composition was observed after training. HET only increased nitrite and reduced superoxide dismutase concentrations.
CONCLUSION
Combining exercise training and hypoxic exposure may provide some additional benefits to standard NET for obese individual health status.",2020,"RESULTS
Peak oxygen consumption and maximal power output increased significantly after HET only (peak oxygen consumption HET + 10 ± 11% versus NET + 1 ± 10% and maximal power output HET + 11 ± 7% versus NET + 3 ± 10%, p < 0.05).","['obese individuals', 'overweight and obese individuals', 'Obese Individuals', 'Twenty-three subjects were randomized into 8-week HET (11 males and 1 female ; age: 52 ± 12 years ; BMI: 31.2 ± 2.4 kg·m) or NET (8 males and 3 females ; age: 56 ± 11 years ; BMI']","['Hypoxic Exercise Training', 'hypoxic exercise training (HET', 'normoxic exercise training (NET', 'HET']","['Submaximal exercise responses', 'Exercise Capacity', 'incremental maximal and submaximal cycling tests, measurements of pulse-wave velocity, endothelial function, fasting glucose, insulin and lipid profile, blood NO metabolites and oxidative stress, determination of body composition by magnetic resonance imaging', 'Except diastolic blood pressure', 'exercise capacity and health status', 'vascular function, metabolic status and body composition', 'Peak oxygen consumption and maximal power output', 'nitrite and reduced superoxide dismutase concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005768'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",23.0,0.0284828,"RESULTS
Peak oxygen consumption and maximal power output increased significantly after HET only (peak oxygen consumption HET + 10 ± 11% versus NET + 1 ± 10% and maximal power output HET + 11 ± 7% versus NET + 3 ± 10%, p < 0.05).","[{'ForeName': 'Samarmar', 'Initials': 'S', 'LastName': 'Chacaroun', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borowik', 'Affiliation': ''}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Vega-Escamilla Y Gonzalez', 'Affiliation': ''}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Doutreleau', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Wuyam', 'Affiliation': ''}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Belaidi', 'Affiliation': ''}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': ''}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pepin', 'Affiliation': ''}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Flore', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Verges', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002322']
2415,32433273,β-Galactooligosaccharide in Conjunction With Low FODMAP Diet Improves Irritable Bowel Syndrome Symptoms but Reduces Fecal Bifidobacteria.,"INTRODUCTION
The low FODMAP diet (LFD) reduces symptoms and bifidobacteria in irritable bowel syndrome (IBS). β-galactooligosaccharides (B-GOS) may reduce the symptoms and increase bifidobacteria in IBS. We investigated whether B-GOS supplementation alongside the LFD improves IBS symptoms while preventing the decline in bifidobacteria.
METHODS
We performed a randomized, placebo-controlled, 3-arm trial of 69 Rome III adult patients with IBS from secondary care in the United Kingdom. Patients were randomized to a sham diet with placebo supplement (control) or LFD supplemented with either placebo (LFD) or 1.4 g/d B-GOS (LFD/B-GOS) for 4 weeks. Gastrointestinal symptoms, fecal microbiota (fluorescent in situ hybridization and 16S rRNA sequencing), fecal short-chain fatty acids (gas-liquid chromatography) and pH (probe), and urine metabolites (H NMR) were analyzed.
RESULTS
At 4 weeks, adequate symptom relief was higher in the LFD/B-GOS group (16/24, 67%) than in the control group (7/23, 30%) (odds ratio 4.6, 95% confidence interval: 1.3-15.6; P = 0.015); Bifidobacterium concentrations (log10 cells/g dry weight) were not different between LFD and LFD/B-GOS but were lower in the LFD/B-GOS (9.49 [0.73]) than in the control (9.77 [0.41], P = 0.018). A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%). Fecal butyrate was lower in the LFD (387.3, P = 0.028) and LFD/B-GOS (346.0, P = 0.007) groups than in the control group (609.2).
DISCUSSION
The LFD combined with B-GOS prebiotic produced a greater symptom response than the sham diet plus placebo, but addition of 1.4 g/d B-GOS did not prevent the reduction of bifidobacteria. The LFD reduces fecal Actinobacteria and butyrate thus strict long-term use should not be advised.",2020,"A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%).","['69 Rome III adult patients with IBS from secondary care in the United Kingdom', 'irritable bowel syndrome (IBS']","['β-Galactooligosaccharide', 'β-galactooligosaccharides (B-GOS', 'sham diet with placebo supplement (control) or LFD supplemented with either placebo (LFD', 'Low FODMAP Diet', 'low FODMAP diet (LFD', 'LFD combined with B-GOS prebiotic', 'placebo']","['Bifidobacterium concentrations', 'Fecal butyrate', 'LFD/B-GOS', 'IBS symptoms', 'adequate symptom relief', 'Gastrointestinal symptoms, fecal microbiota (fluorescent in situ hybridization and 16S rRNA sequencing), fecal short-chain fatty acids (gas-liquid chromatography) and pH (probe), and urine metabolites (H NMR', 'reduction of bifidobacteria', 'symptom response']","[{'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0162789', 'cui_str': 'Fluorescence in situ hybridization'}, {'cui': 'C0035702', 'cui_str': '16S Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0008556', 'cui_str': 'Gas liquid chromatography measurement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0915586,"A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%).","[{'ForeName': 'Bridgette', 'Initials': 'B', 'LastName': 'Wilson', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Tokuwa', 'Initials': 'T', 'LastName': 'Kanno', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, United Kingdom.""}, {'ForeName': 'Gareth C', 'Initials': 'GC', 'LastName': 'Parkes', 'Affiliation': 'Department of Gastroenterology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': ""Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': 'Mason', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, United Kingdom.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Irving', 'Affiliation': ""Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Lomer', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000641']
2416,31513027,Comparison of Short-Term Efficacy Between Endoscopic Submucosal Tunnel Dissection and Endoscopic Submucosal Dissection in Treatment of Wide Esophageal Squamous Cell Carcinoma of Early Stage.,"GOAL
The goal of this study was to compare the efficacy and safety of endoscopic submucosal tunnel dissection (ESTD) with endoscopic submucosal dissection (ESD) for the removal of early-stage esophageal squamous cancer wider than or equal to one half the circumference of the esophagus.
BACKGROUND
Although ESD has been successfully applied for resection of early-stage esophageal cancer, there are still technical challenges and postoperative stenosis when it is applied to treat large lesions.
PATIENTS AND METHODS
A total of 40 patients with early-stage esophageal cancer wider than or equal to one half its circumference were enrolled in this study and randomly assigned to an ESTD or ESD group for treatment of esophageal superficial squamous cell carcinoma. All of the patients received oral steroids after endoscopic dissection. We then compared the 2 groups in terms of average operating time, dissection speed, en bloc resection rate, R0 resection rate, and complications during a 1-year follow-up period.
RESULTS
The dissection speed in the ESTD group was significantly faster than that in the ESD group (P=0.047). There were no significant differences in operating time, en bloc resection rates, or R0 resection rates between the ESTD and ESD group (P=0.319, 1.000, 1.000, respectively). There were also no significant differences in perforation, bleeding, or stenosis rates between the ESTD and ESD group (P=1.000, 0.748, 1.000, respectively).
CONCLUSION
Both ESTD and ESD are safe and effective therapies for early-stage esophageal cancer wider than or equal to one half the esophageal circumference. The dissection speed of ESTD is faster than that of ESD.",2020,"There were no significant differences in operating time, en bloc resection rates, or R0 resection rates between the ESTD and ESD group (P=0.319, 1.000, 1.000, respectively).","['esophageal superficial squamous cell carcinoma', 'Wide Esophageal Squamous Cell Carcinoma of Early Stage', '40 patients with early-stage esophageal cancer wider than or equal to one half its circumference']","['endoscopic submucosal tunnel dissection (ESTD) with endoscopic submucosal dissection (ESD', 'ESTD or ESD', 'Endoscopic Submucosal Tunnel Dissection and Endoscopic Submucosal Dissection', 'ESD', 'oral steroids']","['operating time, en bloc resection rates, or R0 resection rates', 'efficacy and safety', 'perforation, bleeding, or stenosis rates', 'average operating time, dissection speed, en bloc resection rate, R0 resection rate, and complications', 'dissection speed']","[{'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]","[{'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",40.0,0.0222927,"There were no significant differences in operating time, en bloc resection rates, or R0 resection rates between the ESTD and ESD group (P=0.319, 1.000, 1.000, respectively).","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Departments of Gastroenterology.'}, {'ForeName': 'Keyi', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Thoracic Surgery.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Departments of Gastroenterology.'}, {'ForeName': 'Rongli', 'Initials': 'R', 'LastName': 'Cui', 'Affiliation': 'Departments of Gastroenterology.'}, {'ForeName': 'Hejun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Departments of Gastroenterology.'}, {'ForeName': 'Shigang', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Departments of Gastroenterology.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001266']
2417,31510777,Dynamic Changes in the Molecular Signature of Adverse Left Ventricular Remodeling in Patients With Compensated and Decompensated Chronic Primary Mitral Regurgitation.,"BACKGROUND
There is no proven medical therapy that attenuates adverse left ventricular remodeling in patients with chronic primary mitral regurgitation (CPMR). Identification of molecular pathways important in the progression of left ventricular remodeling in patients with CPMR may lead to development of new therapeutic strategies.
METHODS AND RESULTS
We performed baseline echocardiographic, cardiac catheterization, and serum NT-pro-BNP analysis in patients with severe CPMR awaiting mitral valve surgery and stratified the study population into compensated or decompensated CPMR. We obtained left ventricular endomyocardial biopsies (n=12) for mRNA expression analysis, and compared baseline transcript levels of 109 genes important in volume-overload left ventricular remodeling with levels in normal hearts (n=5) and between patients with compensated (n=6) versus decompensated (n=6) CPMR. Patients were then randomized to treatment with and without carvedilol and followed until the time of surgery (mean follow-up 8.3 months) when repeat endomyocardial biopsies were obtained to correlate transcriptional dynamics with indices of adverse remodeling. CPMR was associated with increased NPPA expression levels (21.6-fold, P =0.004), decreased transcripts of genes important in cell survival, and enrichment of extracellular matrix genes. Decompensated CPMR was associated with downregulation of SERCA2 (0.77-fold, P =0.009) and mitochondrial gene expression levels and upregulation of genes related to inflammation, the extracellular matrix, and apoptosis, which were refractory to carvedilol therapy.
CONCLUSIONS
Transition to decompensated CPMR is associated with calcium dysregulation, increased expression of inflammatory, extracellular matrix and apoptotic genes, and downregulation of genes important in bioenergetics. These changes are not attenuated by carvedilol therapy and highlight the need for development of specific combinatorial therapies, targeting myocardial inflammation and apoptosis, together with urgent surgical or percutaneous valve interventions.",2019,"CPMR was associated with increased NPPA expression levels (21.6-fold, P =0.004), decreased transcripts of genes important in cell survival, and enrichment of extracellular matrix genes.","['patients with chronic primary mitral regurgitation (CPMR', 'Patients With Compensated and Decompensated Chronic Primary Mitral Regurgitation', 'patients with severe CPMR awaiting mitral valve surgery and stratified the study population into compensated or decompensated CPMR', 'patients with CPMR', 'normal hearts (n=5) and between patients with compensated (n=6) versus decompensated (n=6) CPMR']",['carvedilol'],"['NPPA expression levels', 'decreased transcripts of genes important in cell survival, and enrichment of extracellular matrix genes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026264', 'cui_str': 'Bicuspid Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}]","[{'cui': 'C0068273', 'cui_str': 'NPPA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}, {'cui': 'C0015350', 'cui_str': 'Extracellular Matrix'}]",,0.0290515,"CPMR was associated with increased NPPA expression levels (21.6-fold, P =0.004), decreased transcripts of genes important in cell survival, and enrichment of extracellular matrix genes.","[{'ForeName': 'Keir', 'Initials': 'K', 'LastName': 'McCutcheon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dickens', 'Affiliation': 'Molecular Biology Laboratory, Department of Internal Medicine (C.D., T.D.-P., R.D.), University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'van Pelt', 'Affiliation': 'Department of Clinical Digestive Oncology, Faculty of Medicine, Katholieke Universiteit, Leuven and Leuven Cancer Institute, Leuven, Belgium (J.v.P.).'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Dix-Peek', 'Affiliation': 'Molecular Biology Laboratory, Department of Internal Medicine (C.D., T.D.-P., R.D.), University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Grinter', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'McCutcheon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Atulkumar', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiothoracic Surgery (A.P.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hale', 'Affiliation': 'Department of Anatomical Pathology (M.H.), University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nqoba', 'Initials': 'N', 'LastName': 'Tsabedze', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Vachiat', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Zachariah', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Duarte', 'Affiliation': 'Molecular Biology Laboratory, Department of Internal Medicine (C.D., T.D.-P., R.D.), University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., S.J.).'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Manga', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.005974']
2418,31356571,Post-operative pain management among surgical trauma patients in an acute ward: a best practice implementation project.,"INTRODUCTION
Effective pain management should be one of the main goals of healthcare professionals. The trauma unit of a hospital in an urban area of Spain carried out an implementation project, guided by the evidence-based criteria from JBI, to put in place the processes and initiatives needed to reduce post-operative pain.
OBJECTIVES
The aim of this implementation project was to promote evidence-based practice in managing post-operative pain.
METHODS
A pre-post implementation audit was implemented using the JBI Practical Application of Clinical Evidence System (PACES) and Getting Research into Practice (GRiP) tool. Each audit included 30 post-operative patients from a randomized sample who were evaluated before the project started and six months after key strategies had been implemented. The criteria were audited according to evidence-based process criteria.
RESULTS
At the baseline audit, the compliance percentages for the evidence-based criteria ranged from 10% to 43%. Seven obstacles were identified in relation to post-operative pain management. Following the GRiP table, the team established a series of strategies and resources to implement the improvement actions. When the implementation period ended, all the criteria had improved.
CONCLUSIONS
The quality improvement cycle allowed us to implement the clinical best practice recommendations, with subsequent outcome improvements for patients. Future audits should be performed to drive new cycles of improvement in evidence-based practice.",2019,"At the baseline audit, the compliance percentages for the evidence-based criteria ranged from 10% to 43%.",['surgical trauma patients in an acute ward'],[],[],"[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}]",[],[],30.0,0.0394675,"At the baseline audit, the compliance percentages for the evidence-based criteria ranged from 10% to 43%.","[{'ForeName': 'Emilia Irene', 'Initials': 'EI', 'LastName': 'García-Monasterio', 'Affiliation': 'Trauma Unit, Lucus Augusti University Hospital, Lugo, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Alvárez-Vázquez', 'Affiliation': 'Quality Unit, Lucus Augusti University Hospital, Lugo, Spain.'}, {'ForeName': 'Purificación', 'Initials': 'P', 'LastName': 'Morado-Quiñoá', 'Affiliation': 'Quality Unit, Lucus Augusti University Hospital, Lugo, Spain.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Pena-Pena', 'Affiliation': 'Trauma Unit, Lucus Augusti University Hospital, Lugo, Spain.'}, {'ForeName': 'Mar Folgueira', 'Initials': 'MF', 'LastName': 'Mazón', 'Affiliation': 'Trauma Unit, Lucus Augusti University Hospital, Lugo, Spain.'}, {'ForeName': 'Ana Murado', 'Initials': 'AM', 'LastName': 'Bouso', 'Affiliation': 'Teaching Unit, Lucus Augusti University Hospital, Lugo, Spain.'}, {'ForeName': 'Angeles Landeira', 'Initials': 'AL', 'LastName': 'López', 'Affiliation': 'Pain Unit, Lucus Augusti University Hospital, Lugo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cendán-Celeiro', 'Affiliation': 'Hospitalization Unit, Lucus Augusti University Hospital, Lugo, Spain.'}]",JBI database of systematic reviews and implementation reports,['10.11124/JBISRIR-2017-003916']
2419,15791966,Randomized comparison between two microlaparoscopic techniques for partial salpingectomy.,"OBJECTIVE
We compared 2 techniques for performing a partial salpingectomy by using microlaparoscopy and either bipolar coagulation or loop ligation.
METHODS
A 3-mm transumbilical laparoscope with secondary midline port sites midway and suprapubically was used to perform a partial salpingectomy in 109 women desiring permanent sterilization. Each patient was randomly assigned to undergo a tubal resection either after Pomeroy ligation (n= 54) or after bipolar coagulation with Kleppinger forceps (n=55). Postoperative pain, as assessed using a 10-point visual analog scale, was the primary comparison endpoint.
RESULTS
No technical difficulties with either technique required conversion to a minilaparotomy. The mean time to remove both tubal segments was not different between techniques (7 minutes, 21 seconds; range, 4 minutes, 25 seconds to 15 minutes, 43 seconds). Each segment (mean, 1.6 cm; range, 0.8 to 3.5 cm) was confirmed in the operating room, then histologically. Postoperative pain at 6 hours was scored similarly (median, ligation 4.6, coagulation 4.0 of 10). Outpatient recovery was the same, unless pelvic pain required overnight observation (ligation, 4 patients; coagulation, 2 patients).
CONCLUSION
Partial salpingectomy, using microlaparoscopy with either bipolar coagulation or loop ligation, was performed with comparable ease, confirmation of the removed tube, and similar postoperative discomfort.",2005,"Postoperative pain at 6 hours was scored similarly (median, ligation 4.6, coagulation 4.0 of 10).",['109 women desiring permanent sterilization'],"['microlaparoscopy with either bipolar coagulation or loop ligation', 'microlaparoscopy and either bipolar coagulation or loop ligation', 'tubal resection either after Pomeroy ligation (n= 54) or after bipolar coagulation with Kleppinger forceps']","['mean time to remove both tubal segments', 'Postoperative pain', '10-point visual analog scale']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0362065', 'cui_str': 'Sterilization'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",109.0,0.0600038,"Postoperative pain at 6 hours was scored similarly (median, ligation 4.6, coagulation 4.0 of 10).","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Siegle', 'Affiliation': 'Departments of Obstetrics and Gynecology, Valley View Regional Hospital, Ada, Oklahoma, USA. coder827@aol.com'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bishop', 'Affiliation': ''}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Rayburn', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2420,31498753,"Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group.","PURPOSE
Combined-modality treatment (CMT) with 2× ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and small-field radiotherapy is standard of care for patients with early-stage favorable Hodgkin lymphoma (HL). However, the role of radiotherapy has been challenged. Positron emission tomography (PET) after 2× ABVD (PET-2) might help to predict individual outcomes and guide treatment.
METHODS
Between November 2009 and December 2015, we recruited patients age 18 to 75 years with newly diagnosed, early-stage favorable HL for this international randomized phase III trial. Patients were assigned to standard CMT of 2× ABVD and 20-Gy involved-field radiotherapy or PET-guided treatment, omitting involved-field radiotherapy after negative PET-2 (Deauville score < 3). Primary objectives were to exclude inferiority of 10% or more in 5-year progression-free survival (PFS) of ABVD alone compared with CMT in a per-protocol analysis among PET-2-negative patients (noninferiority margin for hazard ratio, 3.01) and to confirm PET-2 positivity (Deauville score ≥ 3) as a risk factor for PFS among CMT-treated patients.
RESULTS
We enrolled 1,150 patients. Median follow-up was 45 months. Among 628 PET-2-negative, per-protocol-treated patients, 5-year PFS was 93.4% (95% CI, 90.4% to 96.5%) with CMT and 86.1% (95% CI, 81.4% to 90.9%) with ABVD (difference 7.3% [95% CI, 1.6% to 13.0%]; hazard ratio, 1.78 [95% CI, 1.02 to 3.12]). Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD. Among 693 patients who were assigned to CMT, 5-year PFS was 93.2% (95% CI, 90.2% to 96.2%) among PET-2-negative patients and 88.4% (95% CI, 84.2% to 92.6%) in PET-2-positive patients ( P = .047). When using the more common liver cutoff (Deauville score, 4) for PET-2 positivity, the difference was more pronounced (5-year PFS, 93.1% [95% CI, 90.7% to 95.5%] v 80.9% [95% CI, 72.2% to 89.7%]; P = .0011).
CONCLUSION
In early-stage favorable HL, a positive PET after two cycles ABVD indicates a high risk for treatment failure, particularly when a Deauville score of 4 is used as a cutoff for positivity. In PET-2-negative patients, radiotherapy cannot be omitted from CMT without clinically relevant loss of tumor control.",2019,"Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD.","['We enrolled 1,150 patients', 'Between November 2009 and December 2015', '693 patients', 'patients with early-stage favorable Hodgkin lymphoma (HL', 'Early-Stage Favorable Hodgkin Lymphoma', 'recruited patients age 18 to 75 years with newly diagnosed, early-stage favorable HL for this international randomized phase III trial']","['Positron Emission Tomography-Guided Treatment', 'Combined-modality treatment (CMT) with 2× ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and small-field radiotherapy', 'standard CMT of 2× ABVD and 20-Gy involved-field radiotherapy or PET-guided treatment, omitting involved-field radiotherapy', 'Positron emission tomography (PET', 'radiotherapy']","['5-year PFS', '5-year progression-free survival (PFS) of ABVD', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1150.0,0.269604,"Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Goergen', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Kobe', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Kuhnert', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Lohri', 'Affiliation': 'Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'IIIrd Medical Department, Paracelcus Medical University and Salzburg Cancer Research Institute, Salzburg, Austria.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sasse', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Topp', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Erhardt', 'Initials': 'E', 'LastName': 'Schäfer', 'Affiliation': 'Dres. med. Just/Düwel/Riesenberg/Steinke/Schäfer, Studiengesellschaft, Bielefeld, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Internal Medicine I, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soekler', 'Affiliation': 'University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Vogelhuber', 'Affiliation': 'Medizinische Klinik III, Universitätsklinik Regensburg, Regensburg, Germany.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit, Department of Hematology, Amsterdam, Netherlands.'}, {'ForeName': 'Ulrich Bernd', 'Initials': 'UB', 'LastName': 'Keller', 'Affiliation': 'Department of Internal Medicine III, Klinikum ""Rechts der Isar"", Munich, Germany.'}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Krause', 'Affiliation': 'Department of Internal Medicine 5, Haematology/Oncology, University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Medical Oncology, Klinikum Nürnberg, Paracelsus Medical University, Nürnberg, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Ernst von Bergmann, Potsdam, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Thiemer', 'Affiliation': 'Clinic for Hematology, Oncology and Immunology, Philipps University, Marburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dührsen', 'Affiliation': 'Department of Haematology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Meissner', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Viardot', 'Affiliation': 'Department of Internal Medicine III, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eich', 'Affiliation': 'Department of Radiotherapy, University Hospital of Muenster, Muenster, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baues', 'Affiliation': 'Department of Radiotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, Julius Maximilian University of Würzburg and Comprehensive Cancer Center Mainfranken, Würzburg, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'von Tresckow', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Dietlein', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00964']
2421,32097119,Optimization of Upper Extremity Rehabilitation by Combining Telerehabilitation With an Exergame in People With Chronic Stroke: Protocol for a Mixed Methods Study.,"BACKGROUND
Exergames have the potential to provide an accessible, remote approach for poststroke upper extremity (UE) rehabilitation. However, the use of exergames without any follow-up by a health professional could lead to compensatory movements during the exercises, inadequate choice of difficulty level, exercises not being completed, and lack of motivation to pursue exercise programs, thereby decreasing their benefits. Combining telerehabilitation with exergames could allow continuous adjustment of the exercises and monitoring of the participant's completion and adherence. At present, there is limited evidence regarding the feasibility or efficacy of combining telerehabilitation and exergames for stroke rehabilitation.
OBJECTIVE
This study aims to (1) determine the preliminary efficacy of using telerehabilitation combined with exergames on UE motor recovery, function, quality of life, and motivation in participants with chronic stroke, compared with conventional therapy (the graded repetitive arm supplementary program; GRASP); (2) examine the feasibility of using the technology with participants diagnosed with stroke at home; and (3) identify the obstacles and facilitators for its use by participants diagnosed with stroke and stroke therapists and understand the shared decision-making process.
METHODS
A mixed methods study protocol is proposed, including a randomized, blinded feasibility trial with an embedded multiple case study. The intervention consists of the provision of a remote rehabilitation program, during which participants will use the Jintronix exergame for UE training and the Reacts Application to conduct videoconferenced sessions with the therapists (physical or occupational therapists). We plan to recruit 52 participants diagnosed with stroke, randomly assigned to a control group (n=26; 2-month on-paper home exercise program: the GRASP with no supervision) and an experimental group (n=26; 2-month home program using the technology). The primary outcome is the Fugl-Meyer UE Assessment, a performance-based measure of UE impairment. The secondary outcomes are self-reported questionnaires and include the Motor Activity Log-28 (quality and frequency of use of the UE), Stroke Impact Scale-16 (the quality of life), and Treatment Self-Regulation Questionnaire (motivation). Feasibility data include process, resources, management, and scientific outcomes. Qualitative data will be collected by interviews with both participants and therapists.
RESULTS
At present, data collection was ongoing with one participant who had completed the exergame- telerehabilitation based intervention. We expect to collect preliminary efficacy data of this technology on the functional and motor recovery of the UE, following a stroke; collect feasibility data with users at home (adherence, safety, and technical difficulties); and identify the obstacles and facilitators for the technology use and understand the shared decision-making process.
CONCLUSIONS
This paper describes the protocol underlying the study of a telerehabilitation-exergame technology to contribute to understanding its feasibility and preliminary efficacy for UE stroke rehabilitation.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03759106; http://clinicaltrials.gov/show/NCT03759106.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/14629.",2020,"BACKGROUND
Exergames have the potential to provide an accessible, remote approach for post stroke upper extremity (UE) rehabilitation.","['participants with chronic stroke, compared with conventional therapy (the graded repetitive arm supplementary program) 2', '52 stroke participants', 'people with chronic stroke']","['Jintronix exergame for UE training and the Reacts Application to conduct video conferenced sessions with the therapists (physical or occupational therapists', 'control group (n=26, 2 months on-paper home exercise program: the graded repetitive arm supplementary program with no supervision']","['self-reported questionnaires and include the Motor Activity Log-28 (quality and frequency of use of the UE in 28 everyday tasks), Stroke Impact Scale-16 (impact on quality of life) and Treatment Self-Regulation Questionnaire (motivation', 'Feasibility data include process (recruitment and retention rates), resources (exercise adherence, time spent with therapist,), management (technical problems)and scientific (safety, simple size) outcomes', 'Fugl-Meyer UE Assessment, a performance-based measure of UE impairment', 'UE motor recovery, function, quality of life and motivation']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0441661', 'cui_str': 'Everyday tasks (observable entity)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",52.0,0.0591919,"BACKGROUND
Exergames have the potential to provide an accessible, remote approach for post stroke upper extremity (UE) rehabilitation.","[{'ForeName': 'Dorra Rakia', 'Initials': 'DR', 'LastName': 'Allegue', 'Affiliation': 'School of Rehabilitation, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Kairy', 'Affiliation': 'School of Rehabilitation, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Higgins', 'Affiliation': 'School of Rehabilitation, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Archambault', 'Affiliation': 'McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Michaud', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Miller', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Shane Norman', 'Initials': 'SN', 'LastName': 'Sweet', 'Affiliation': 'The Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Institut universitaire sur la réadaptation en déficience physique de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Tousignant', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, QC, Canada.'}]",JMIR research protocols,['10.2196/14629']
2422,32436390,Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings from the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.,"Background: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. Methods: We linked adults aged ≥65 in the US CoreValve Pivotal High Risk (HiR) and Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trials to 100% Medicare inpatient claims, 1/1/2003-12/31/2016. Primary (e.g. death and stroke) and secondary trial endpoints, were compared across treatment arms (e.g. TAVR vs. SAVR) using trial-adjudicated outcomes versus outcomes derived from claims at 1-year (HiR) or 2-years (SURTAVI). Results: Among 600 linked CoreValve HiR participants (linkage rate 80.0%), the rate of the trial's primary endpoint of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1-year using both trial data (HR 0.84, 95% CI 0.65-1.09; p= 0.33) and claims data (HR 0.86, 95% CI 0.66-1.11; p = 0.34; interaction p-value = 0.80). Noninferiority of TAVR relative to SAVR was seen using both trial and claims-based outcomes (p noninferiority < 0.001 for both). Among 1005 linked SURTAVI trial participants (linkage rate 60.5%), the trial's primary endpoint was 12.9% for TAVR and 13.1% for SAVR using trial data (HR 1.08, 95% CI 0.79-1.48, p = 0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (HR 1.02, 95% CI 0.73-1.41, p = 0.58; interaction p-value = 0.89). TAVR was noninferior to SAVR when compared using both trial and claims (p non-inferiority < 0.001 for both). Rates of procedural secondary outcomes (e.g. aortic valve reintervention, pacemaker rates) were more closely concordant between trial and claims data than non-procedural outcomes (e.g., stroke, bleeding, cardiogenic shock). Conclusions: In the CoreValve HiR and SURTAVI trials, ascertainment of trial primary endpoints using claims reproduced both the magnitude and direction of treatment effect compared with adjudicated event data, but non-fatal and non-procedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes, but may be less suitable for other endpoints.",2020,TAVR was noninferior to SAVR when compared using both trial and claims (p non-inferiority < 0.001 for both).,"['adults aged ≥65 in the US CoreValve Pivotal High Risk (HiR) and Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trials to 100% Medicare inpatient claims, 1/1/2003-12/31/2016']","['TAVR', 'Transcatheter Aortic Valve Replacement']","['cause mortality', 'aortic valve reintervention, pacemaker rates', 'claims at 1-year (HiR) or 2-years (SURTAVI', 'stroke, bleeding, cardiogenic shock']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}]",1005.0,0.276108,TAVR was noninferior to SAVR when compared using both trial and claims (p non-inferiority < 0.001 for both).,"[{'ForeName': 'Jordan B', 'Initials': 'JB', 'LastName': 'Strom', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Kamil F', 'Initials': 'KF', 'LastName': 'Faridi', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Neel M', 'Initials': 'NM', 'LastName': 'Butala', 'Affiliation': 'Harvard Medical School, Boston, MA; Division of Cardiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Yuansong', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Tamez', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Valsdottir', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'J Matthew', 'Initials': 'JM', 'LastName': 'Brennan', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA; Baim Institute for Clinical Research, Boston, MA.'}, {'ForeName': 'Dhruv S', 'Initials': 'DS', 'LastName': 'Kazi', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Yeh', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA; Baim Institute for Clinical Research, Boston, MABaim Institute for Clinical Research, Boston, MA.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046159']
2423,31490536,Assessment of the End Point Adjudication Process on the Results of the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: A Secondary Analysis.,"Importance
Debate continues about the value of event adjudication in clinical trials and whether independent centralized assessments improve reliability and validity of study results in masked randomized trials compared with local, investigator-assessed end points.
Objective
To assess the results of the adjudicated end point process in the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial by comparing end points assessed by local site investigators with centrally adjudicated end points.
Design, Setting, and Participants
This is an ad hoc secondary analysis of a randomized, double-blind clinical trial comparing safety and effectiveness of clopidogrel bisulphate plus aspirin vs placebo plus aspirin. Patients received either 600 mg of clopidogrel bisulphate on day 1, then 75 mg per day through day 90 plus 50 to 325 mg of aspirin per day, or the same range of dosages of placebo plus aspirin. Investigators reported all potential end points; independent masked adjudicators were randomly assigned to review using definitions specified in the study protocol. This was a multicenter study; 269 international sites in 10 countries enrolled from May 28, 2010, to December 19, 2017. The study enrolled 4881 patients 18 years or older with transient ischemic attack or minor acute ischemic stroke within 12 hours of symptom onset and followed for 90 days from randomization; last follow-up was completed in March 2018.
Main Outcomes and Measures
Independent adjudicators external to the study and masked to study treatment assignment adjudicated 467 primary and secondary effectiveness outcomes and major and minor bleeding events, including the primary composite end point, which was the risk of a composite of major ischemic events at 90 days, defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event. The primary safety end point was major hemorrhage. All components of the primary and safety outcomes were adjudicated.
Results
In this secondary analysis of an international randomized clinical trial, a total of 269 sites worldwide randomized 4881 patients (median age, 65.0 years; interquartile range, 55-74 years); 55.0% were male. The primary results have been published previously. The hazard ratios for clopidogrel plus aspirin vs placebo plus aspirin for the primary composite end point were 0.75 (95% CI, 0.59-0.95) for adjudicator-assessed events and 0.76 (95% CI, 0.60-0.95) for investigator-assessed events. Agreement between adjudicator and investigator assessments was 90.7%. The hazard ratios for clopidogrel plus aspirin vs placebo plus aspirin for the primary safety end point were 2.32 (95% CI, 1.10-4.87) for adjudicator-assessed events and 2.58 (95% CI, 1.19-5.58) for investigator-assessed events, with an agreement rate of 77.5%.
Conclusions and Relevance
Independent end point adjudication did not substantially alter estimates of the primary treatment effectiveness in the POINT trial.
Trial Registration
ClinicalTrials.gov identifier: NCT00991029.",2019,"The hazard ratios for clopidogrel plus aspirin vs placebo plus aspirin for the primary composite end point were 0.75 (95% CI, 0.59-0.95) for adjudicator-assessed events and 0.76","['4881 patients 18 years or older with transient ischemic attack or minor acute ischemic stroke within 12 hours of symptom onset and followed for 90 days from randomization; last follow-up was completed in March 2018', 'multicenter study; 269 international sites in 10 countries enrolled from May 28, 2010, to December 19, 2017', '269 sites worldwide randomized 4881 patients (median age, 65.0 years; interquartile range, 55-74 years); 55.0% were male']","['clopidogrel bisulphate', 'clopidogrel bisulphate plus aspirin vs placebo plus aspirin', 'placebo plus aspirin', 'aspirin']","['secondary effectiveness outcomes and major and minor bleeding events, including the primary composite end point, which was the risk of a composite of major ischemic events at 90 days, defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event', 'Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT', 'major hemorrhage', 'hazard ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",467.0,0.646926,"The hazard ratios for clopidogrel plus aspirin vs placebo plus aspirin for the primary composite end point were 0.75 (95% CI, 0.59-0.95) for adjudicator-assessed events and 0.76","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Farrant', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Adelman', 'Affiliation': 'Department of Neurology, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'Brett L', 'Initials': 'BL', 'LastName': 'Cucchiara', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Holly J', 'Initials': 'HJ', 'LastName': 'Tillman', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Wenle', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Pauls', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Walsh', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': 'Department of Neurology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, The University of Texas at Austin.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.10769']
2424,31502003,The Effect of Fibrinogen/Thrombin-Coated Collagen Patch (TachoSil ® ) Application in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreaticoduodenectomy: A Randomized Clinical Trial.,"BACKGROUND
Fibrin sealants and topical glue have been studied to reduce the incidence of postoperative pancreatic fistulas (POPF) after pancreatico-enteric anastomosis, but a definitive innovation is still needed. We aim to evaluate the effectiveness of fibrin sealant patch applied to pancreatico-enteric anastomosis to reduce postoperative complications, including POPF.
METHODS
This study was a single-center, prospective, randomized, phase IV trial involving three pancreaticobiliary surgeons. The primary outcome was POPF; secondary outcomes included complications, drain removal days, hospital stay, readmission rate, and cost. Risk factors for POPF were identified by logistic regression analysis.
RESULTS
A total of 124 patients were enrolled. Biochemical leakage (BL) or POPF occurred in 16 patients (25.8%) in the intervention group and 23 patients (37.1%) in the control group (no statistical significance). Clinically relevant POPF occurred in 4 patients (6.5%) in both the intervention and control groups (p = 1.000). Hospital stay (11.6 days vs. 12.1 days, p = 0.585) and drain removal days (5.7 days vs. 5.3 days, p = 0.281) were not statistically different between two groups. Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103). In multivariable analysis, age and soft pancreas texture were independent risk factors for BL or POPF in this study. Applying fibrin sealant patch is not a negative risk factor, but the p value may indicate a likelihood of reducing the incidence of BL (p = 0.084).
CONCLUSIONS
Fibrin sealant patches after pancreaticojejunostomy did not reduce the incidence of POPF or other postoperative complications. This study was registered at clinicaltrials.gov (NCT03269955).",2019,"Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103).",['124 patients were enrolled'],"['fibrin sealant patch', 'Fibrinogen/Thrombin-Coated Collagen Patch (TachoSil ® ']","['drain removal days', 'Biochemical leakage (BL) or POPF', 'incidence of POPF', 'Clinically relevant POPF', 'complications, drain removal days, hospital stay, readmission rate, and cost', 'Hospital stay', 'Complication rates', 'readmission rates']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1276898', 'cui_str': 'Fibrinogen / Thrombin'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C1871272', 'cui_str': 'TachoSil'}]","[{'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",124.0,0.166,"Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103).","[{'ForeName': 'Jaewoo', 'Initials': 'J', 'LastName': 'Kwon', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Division of Hepatobiliary-Pancreatic Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-Ro, Gangnam-gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Sukyung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Guisuk', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Yejong', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Seung Jae', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Woohyung', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Ki Byung', 'Initials': 'KB', 'LastName': 'Song', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Dae Wook', 'Initials': 'DW', 'LastName': 'Hwang', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Song Cheol', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Division of Hepato-Biliary and Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine and Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-gu, Seoul, 05505, South Korea. hbpsurgeon@gmail.com.'}]",World journal of surgery,['10.1007/s00268-019-05172-y']
2425,31494097,"Safety and efficacy of AMG 714 in patients with type 2 refractory coeliac disease: a phase 2a, randomised, double-blind, placebo-controlled, parallel-group study.","BACKGROUND
Refractory coeliac disease type 2 is a rare subtype of coeliac disease with high mortality rates; interleukin 15 (IL-15) is strongly implicated in its pathophysiology. This trial aimed to investigate the effects of AMG 714, an anti-IL-15 monoclonal antibody, on the activity and symptoms of refractory coeliac disease type 2.
METHODS
This was a randomised, double-blind, placebo-controlled, phase 2a study of adults with a confirmed diagnosis of refractory coeliac disease type 2. Patients were randomly assigned at a 2:1 ratio to receive seven intravenous doses over 10 weeks of AMG 714 (8 mg/kg) or matching placebo. Biopsy samples were obtained at baseline and week 12 for cellular analysis and histology. The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry. Secondary endpoints were the change in aberrant intraepithelial lymphocytes with respect to intestinal epithelial cells; intestinal histological scores (villous height-to-crypt depth ratio; VHCD); intraepithelial lymphocyte counts; Marsh score; and patient-reported symptom measures, including the Bristol stool form scale (BSFS) and gastrointestinal symptom rating scale (GSRS). Main analyses were done in the per-protocol population of patients who received their assigned treatment, provided evaluable biopsy samples, and did not have major protocol deviations; only patients with non-atypical disease were included in the analyses of aberrant intraepithelial lymphocytes, including the primary analysis. Safety was assessed in all patients who received at least one dose of study drug. This study is registered at ClinicalTrials.gov (NCT02633020) and EudraCT (2015-004063-36).
FINDINGS
From April 13, 2016, to Jan 19, 2017, 28 patients were enrolled and randomly assigned to AMG 714 (n=19) and placebo (n=9). Six patients were not included in the primary analysis because of protocol deviation (one in the AMG 714 group), insufficient biopsy samples (one in the AMG 714 group), and atypical intraepithelial lymphocytes (three in the AMG 714 group and one in the placebo group). At 12 weeks, the least square mean difference between AMG 714 and placebo in the relative change from baseline in aberrant intraepithelial lymphocyte percentage was -4·85% (90% CI -30·26 to 20·56; p=0·75). The difference between the AMG 714 and placebo groups in aberrant intraepithelial lymphocytes with respect to epithelial cells at 12 weeks was -38·22% (90% CI -95·73 to 19·29; nominal p=0·18); the difference in change in Marsh score from baseline was 0·09% (95% CI -1·60-1·90; nominal p=0·92); the difference in VHCD ratio was 10·67% (95% CI -38·97 to 60·31; nominal p=0·66); and the difference in change in total intraepithelial lymphocyte count was -12·73% (95% CI -77·57-52·12); nominal p=0·69). Regarding symptoms, the proportion of patients with diarrhoea per the BSFS score decreased from ten (53%) of 19 at baseline to seven (37%) of 19 at week 12 in the AMG 714 group and increased from two (22%) of nine at baseline to four (44%) of nine at week 12 in the placebo group (nominal p=0·0008); and the difference between the groups in change in GSRS score was -0·14 (SE 0·19; nominal p=0·48). Eight (89%) patients in the placebo group and 17 (89%) in the AMG 714 group had treatment-emergent adverse events, including one (11%) patient in the placebo group and five (26%) in the AMG 714 group who had serious adverse events. The most common adverse event in the AMG 714 group was nasopharyngitis (eight [42%] patients vs one [11%] in the placebo group).
INTERPRETATION
In patients with refractory coeliac disease type 2 who were treated with AMG 714 or placebo for 10 weeks, there was no difference between the groups in terms of the primary endpoint of aberrant intraepithelial lymphocyte reduction from baseline. Effects on symptoms and other endpoints suggest that further research of AMG 714 may be warranted in patients with refractory coeliac disease type 2.
FUNDING
Celimmune and Amgen.",2019,The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry.,"['adults with a confirmed diagnosis of refractory coeliac disease type 2', 'patients with refractory coeliac disease type 2 who were treated with', 'patients with type 2 refractory coeliac disease', 'patients with refractory coeliac disease type 2', 'Six patients were not included in the primary analysis because of protocol deviation (one in the AMG 714 group), insufficient biopsy samples (one in the AMG 714 group), and atypical intraepithelial lymphocytes (three in the AMG 714 group and one in the placebo group', 'From April 13, 2016, to Jan 19, 2017, 28 patients']","['AMG 714 (8 mg/kg) or matching placebo', 'AMG', 'placebo', 'EudraCT', 'AMG 714 or placebo']","['BSFS score', 'GSRS score', 'Safety', 'VHCD ratio', 'Safety and efficacy', 'proportion of aberrant intraepithelial lymphocytes', 'aberrant intraepithelial lymphocytes with respect to epithelial cells', 'nasopharyngitis', 'treatment-emergent adverse events', 'change in aberrant intraepithelial lymphocytes with respect to intestinal epithelial cells; intestinal histological scores (villous height-to-crypt depth ratio; VHCD); intraepithelial lymphocyte counts; Marsh score; and patient-reported symptom measures, including the Bristol stool form scale (BSFS) and gastrointestinal symptom rating scale (GSRS', 'aberrant intraepithelial lymphocyte reduction', 'total intraepithelial lymphocyte count', 'aberrant intraepithelial lymphocyte percentage', 'serious adverse events', 'change in Marsh score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample (specimen)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C1512944', 'cui_str': 'Intraepithelial T Cells'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C1512944', 'cui_str': 'Intraepithelial T Cells'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0014597', 'cui_str': 'Epithelial Cells'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1721089', 'cui_str': 'Marshes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",714.0,0.631348,The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry.,"[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Cellier', 'Affiliation': 'Department of Gastroenterology and Endoscopy, University Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France. Electronic address: christophe.cellier@aphp.fr.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Bouma', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van Gils', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Sherine', 'Initials': 'S', 'LastName': 'Khater', 'Affiliation': 'Department of Gastroenterology and Endoscopy, University Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Malamut', 'Affiliation': 'Department of Gastroenterology and Endoscopy, University Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Crespo', 'Affiliation': 'Department of Gastroenterology, University Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Collin', 'Affiliation': 'Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Peter H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Celiac Disease Center, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sheila E', 'Initials': 'SE', 'LastName': 'Crowe', 'Affiliation': 'Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medicine, University of California San Diego, Celimmune, Bethesda, MD, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Butz', 'Affiliation': 'Department of Medicine, University of California San Diego, Celimmune, Bethesda, MD, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Cerf-Bensussan', 'Affiliation': 'Laboratory of Intestinal Immunity and Institut Imagine, Paris, France.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Macintyre', 'Affiliation': 'Haematology, Université Paris Descartes, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Parnes', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Leon', 'Affiliation': 'Department of Medicine, University of California San Diego, Celimmune, Bethesda, MD, USA; Provention Bio, Oldwick, NJ, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Haematology, Université Paris Descartes, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Mulder', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30265-1']
2426,31496440,Constraint-induced or multi-modal personalized aphasia rehabilitation (COMPARE): A randomized controlled trial for stroke-related chronic aphasia.,"RATIONALE
The comparative efficacy and cost-effectiveness of constraint-induced and multi-modality aphasia therapy in chronic stroke are unknown.
AIMS AND HYPOTHESES
In the COMPARE trial, we aim to determine whether Multi-Modal Aphasia Treatment (M-MAT) and Constraint-Induced Aphasia Therapy Plus (CIAT-Plus) are superior to usual care (UC) for chronic post-stroke aphasia. Primary hypothesis: CIAT-Plus and M-MAT will reduce aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ)) compared with UC: CIAT-Plus superior for moderate aphasia; M-MAT superior for mild and severe aphasia.
SAMPLE SIZE ESTIMATES
A total of 216 participants (72 per arm) will provide 90% power to detect a 5-point difference on the WAB-R-AQ between CIAT-Plus or M-MAT and UC at α = 0.05.
METHODS AND DESIGN
Prospective, randomized, parallel group, open-label, assessor blinded trial. Participants: Stroke >6 months; aphasia severity categorized using WAB-R-AQ. Computer-generated blocked and stratified randomization by aphasia severity (mild, moderate, and severe), to 3 arms: CIAT-Plus, M-MAT (both 30 h therapy over two weeks); UC (self-reported usual community care).
STUDY OUTCOMES
WAB-R-AQ immediately post-intervention. Secondary outcomes: WAB-R-AQ at 12-week follow-up; naming scores, discourse measures, Communicative Effectiveness Index, Scenario Test, and Stroke and Aphasia Quality of Life Scale-39 g immediately and at 12 weeks post-intervention; incremental cost-effectiveness ratios compared with UC at 12 weeks.
DISCUSSION
This trial will determine whether CIAT-Plus and M-MAT are superior and more cost-effective than UC in chronic aphasia. Participant subgroups with the greatest response to CIAT-Plus and M-MAT will be described.",2019,"Primary hypothesis: CIAT-Plus and M-MAT will reduce aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ)) compared with UC: CIAT-Plus superior for moderate aphasia; M-MAT superior for mild and severe aphasia.
",['Participants: Stroke >6 months; aphasia severity categorized using WAB-R-AQ'],"['Constraint-induced or multi-modal personalized aphasia rehabilitation (COMPARE', 'CIAT-Plus and M-MAT', 'constraint-induced and multi-modality aphasia therapy', 'Multi-Modal Aphasia Treatment (M-MAT) and Constraint-Induced Aphasia Therapy Plus (CIAT-Plus']","['cost-effectiveness ratios', 'WAB-R-AQ', 'WAB-R-AQ at 12-week follow-up; naming scores, discourse measures, Communicative Effectiveness Index, Scenario Test, and Stroke and Aphasia Quality of Life Scale-39', 'aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4273775', 'cui_str': 'WAB-R - Western Aphasia Battery-Revised'}]",216.0,0.120584,"Primary hypothesis: CIAT-Plus and M-MAT will reduce aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ)) compared with UC: CIAT-Plus superior for moderate aphasia; M-MAT superior for mild and severe aphasia.
","[{'ForeName': 'Miranda L', 'Initials': 'ML', 'LastName': 'Rose', 'Affiliation': 'Department of Speech Pathology, Audiology and Orthoptics, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Copland', 'Affiliation': 'Centre of Research Excellence in Aphasia Recovery and Rehabilitation, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': 'Nickels', 'Affiliation': 'Centre of Research Excellence in Aphasia Recovery and Rehabilitation, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'Centre of Research Excellence in Aphasia Recovery and Rehabilitation, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'Centre of Research Excellence in Aphasia Recovery and Rehabilitation, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Rai', 'Affiliation': 'Graduate Research School, University of Technology Sydney, Australia.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Cadilhac', 'Affiliation': 'Centre of Research Excellence in Aphasia Recovery and Rehabilitation, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Joosup', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Foster', 'Affiliation': 'Department of Speech Pathology, Audiology and Orthoptics, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Carragher', 'Affiliation': 'Department of Speech Pathology, Audiology and Orthoptics, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Hurley', 'Affiliation': 'Department of Speech Pathology, Audiology and Orthoptics, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Godecke', 'Affiliation': 'Centre of Research Excellence in Aphasia Recovery and Rehabilitation, La Trobe University, Melbourne, Australia.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019870401']
2427,31498699,"Response by Schrage et al to Letter Regarding Article, ""Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock: A Matched-Pair IABP-SHOCK II Trial 30-Day Mortality Analysis"".",,2019,,['Acute Myocardial Infarction Complicated by Cardiogenic Shock'],[],[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}]",[],[],,0.0575052,,"[{'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schrage', 'Affiliation': 'University Heart Centre Hamburg, Department of General and Interventional Cardiology, Germany (B.S., D.W.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen am Rhein, Germany (S.S., U.Z.).'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen am Rhein, Germany (S.S., U.Z.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology, Germany (H.T.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Westermann', 'Affiliation': 'University Heart Centre Hamburg, Department of General and Interventional Cardiology, Germany (B.S., D.W.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041637']
2428,14626395,"The effect of preincisional periportal infiltration with ropivacaine in pain relief after laparoscopic procedures: a prospective, randomized controlled trial.","BACKGROUND AND OBJECTIVES
It is essential to minimize pain after laparoscopic surgery. This study examined the effect of wound infiltration by a long-acting local anesthetic.
METHODS
This prospective, randomized study includes 190 laparoscopic procedures carried out by the same surgeon. The patients were randomly allocated into 2 groups. The control group comprised 75 cases of laparoscopic cholecystectomy (LC) and 20 cases of laparoscopic inguinal hernia repair (LIHR) without the use of a local anesthetic; only saline was used. The study group comprised 75 cases of LC and 20 cases of LIHR with preincisional periportal infiltration with 20 mL of ropivacaine (10 mg/mL). The postoperative pain scores at 3, 6, 12, and 24 hours determined with a visual analogue scale (VAS), nausea, and the kind and amount of analgesic drugs were assessed.
RESULTS
In the study group in 41% of LC cases and 85% of LIHR cases, no analgesia was required at all; likewise, in the control group in 20% of LC cases and 44% of LIHR cases, no analgesia was required. The difference was statistically significant (P<0.05). In the remainder, pain at 3 and 6 hours and total analgesic requirements in the study group were less than that in the control group (P<0.05). The postoperative nausea and shoulder pain remained statistically unchanged (P>0.05).
CONCLUSIONS
It seems that wound infiltration with ropivacaine in laparoscopy provides satisfactory postoperative analgesia, diminishing or reducing the need for opioids.",2003,"The postoperative nausea and shoulder pain remained statistically unchanged (P>0.05).
","['10 mg/mL', 'pain relief after laparoscopic procedures', '75 cases of LC and 20 cases of LIHR with preincisional periportal infiltration with 20 mL of', '190 laparoscopic procedures carried out by the same surgeon']","['ropivacaine', 'laparoscopic inguinal hernia repair (LIHR) without the use of a local anesthetic; only saline', 'laparoscopic cholecystectomy (LC']","['visual analogue scale (VAS), nausea, and the kind and amount of analgesic drugs', 'postoperative nausea and shoulder pain', 'total analgesic requirements', 'postoperative pain scores']","[{'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0521291', 'cui_str': 'Laparoscopic-assisted procedure'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.058339,"The postoperative nausea and shoulder pain remained statistically unchanged (P>0.05).
","[{'ForeName': 'Theodoros E', 'Initials': 'TE', 'LastName': 'Pavlidis', 'Affiliation': 'Second Surgical Department of Medical Faculty of the Aristotles University of Thessaloniki, G. Gennimatas Hospital, Greece. pavlidth@med.auth.gr'}, {'ForeName': 'Konstantinos S', 'Initials': 'KS', 'LastName': 'Atmatzidis', 'Affiliation': ''}, {'ForeName': 'Basilios T', 'Initials': 'BT', 'LastName': 'Papaziogas', 'Affiliation': ''}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Makris', 'Affiliation': ''}, {'ForeName': 'Charalabos N', 'Initials': 'CN', 'LastName': 'Lazaridis', 'Affiliation': ''}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Papaziogas', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2429,31419309,"Assessment of the impact of sex in intensity, skin flares and central processing of histaminergic itch-A pilot study.","Itch is the commonest skin-related symptom, and sex differences are increasingly recognised as important determinants in stratified medicine, but only little is known about sex differences in itch. Questionnaire-based studies indicated that women perceive itch as more intensive and bothersome in comparison with men. However, data of studies using standardised itch models to objectify sex differences are scarce and inconsistent. To determine sex differences in intensity, skin flares and central processing of histaminergic itch, we compared 15 female and 15 male healthy subjects in a double-blinded, within-subject, placebo-controlled study using a histamine skin prick itch model (histamine 1% applied onto the volar forearm) and functional MRI. We found trends in higher mean itch intensity (0.58 VAS, CI 95% 0.004-1.19, P = .056) and maximum itch intensity (men 3.93 VAS ± 0.39 SD at 3 minutes, women 4.73 VAS ± 0.31 SD at 4 minutes, P = .073) in women paralleled by a trend in a stronger positive correlation between itch intensity and blood oxygen level-dependent (BOLD) activity in brain structures identified during itch in comparison with men (r s in women: .46, P = .08, r s in men: .07, P = .79). The erythema and wheal following histamine skin pricking were (non-significantly) larger in men, indicating that higher mean itch intensities on the right volar forearm in women may not be explained by more intense flares. The comparison of the activation patterns between the sexes revealed increased activity in men compared to women in the left middle temporal gyrus (temporooccipital part)/lateral occipital cortex. Thus, our findings indicate that histaminergic itch perception and central itch processing differ between the sexes under standardised conditions.",2019,The comparison of the activation patterns between the sexes revealed increased activity in men compared to women in the left middle temporal gyrus (temporooccipital part)/lateral occipital cortex.,"['women', '15 female and 15 male healthy subjects']","['placebo', 'histamine skin prick itch-model (histamine 1% applied onto the volar forearm) and functional MRI', 'histamine skin pricking']","['maximum itch intensity', 'activity', 'blood oxygen level dependent (BOLD) activity', 'mean itch intensity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0844804,The comparison of the activation patterns between the sexes revealed increased activity in men compared to women in the left middle temporal gyrus (temporooccipital part)/lateral occipital cortex.,"[{'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Mueller', 'Affiliation': 'Department of Dermatology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mueller', 'Affiliation': 'Department of Psychiatry, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Reinhardt', 'Affiliation': 'Division of Diagnostic and Interventional Neuroradiology, Department of Radiology, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Itin', 'Affiliation': 'Department of Dermatology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Navarini', 'Affiliation': 'Department of Dermatology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stippich', 'Affiliation': 'Division of Diagnostic and Interventional Neuroradiology, Department of Radiology, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Department of Psychiatry, University of Basel, Basel, Switzerland.'}]",Experimental dermatology,['10.1111/exd.14021']
2430,32436761,Glyceryl trinitrate in first-episode psychosis unmedicated with antipsychotics: A randomised controlled pilot study.,"BACKGROUND
There is a pressing need for new classes of treatment for psychosis. A key therapeutic target for novel compounds is the NMDA receptor, which may be modulated by nitric oxide donors such as sodium nitroprusside (SNP). Recent studies of SNP in patients with psychosis have mixed results, and the drug has to be administered intravenously. Glyceryl trinitrate (GTN) is a well-established cardiovascular medicine that is also a nitric oxide donor, and can be given orally.
AIMS
We explored the safety and potential effects of GTN in unmedicated patients with a first episode of psychosis.
METHODS
This was a single-centre, randomised, double-blind, placebo-controlled trial from December 2016 to April 2019 (ClinicalTrials.gov identifier: NCT02906553). Patients received 3 × sprays of GTN or placebo for three consecutive days, and were re-assessed on Days 1, 2, 3 and 7. The primary outcome was cognition (Jumping to Conclusions task), secondary outcomes were symptoms (Positive and Negative Syndrome Scale (PANSS)), verbal memory (Hopkins Verbal Learning task), and mood (Bond-Lader Visual Analogue Scales).
RESULTS
Nineteen patients were randomised, and 13 participants were included in the analyses. Compared with placebo, GTN was well tolerated, but was not associated with significant effects on cognition, symptoms, or mood. Bayesian statistics indicate that our results were 2× more likely under the null hypothesis than the alternative hypothesis, providing anecdotal evidence that GTN does not improve psychotic symptoms.
CONCLUSIONS
We found no indication of an effect of GTN on symptoms of psychosis or cognition.",2020,"Compared with placebo, GTN was well tolerated, but was not associated with significant effects on cognition, symptoms, or mood.","['Nineteen patients were randomised, and 13 participants were included in the analyses', 'patients with psychosis', 'unmedicated patients with a first episode of psychosis', 'controlled trial from December 2016 to April 2019 (ClinicalTrials.gov identifier', 'first-episode psychosis unmedicated with antipsychotics']","['GTN', 'Glyceryl trinitrate (GTN', 'SNP', 'placebo, GTN', '3 × sprays of GTN or placebo', 'Glyceryl trinitrate', 'placebo']","['tolerated', 'cognition (Jumping to Conclusions task), secondary outcomes were symptoms (Positive and Negative Syndrome Scale (PANSS)), verbal memory (Hopkins Verbal Learning task), and mood (Bond-Lader Visual Analogue Scales', 'symptoms of psychosis or cognition', 'psychotic symptoms', 'cognition, symptoms, or mood']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}]",19.0,0.469584,"Compared with placebo, GTN was well tolerated, but was not associated with significant effects on cognition, symptoms, or mood.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Merritt', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Catalan', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cowley', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Arsime', 'Initials': 'A', 'LastName': 'Demjaha', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Cooper', 'Affiliation': 'Newham Centre for Mental Health, Unit for Social and Community Psychiatry, Queen Mary University of London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922967']
2431,32433138,Modeling Medical Education: The Impact of Three-Dimensional Printed Models on Medical Student Education in Plastic Surgery.,"PURPOSE
Trainee exposure to craniofacial pathology can be limited due to rare disease presentation, revealing a need for tools that assist in visualizing complex 3D pathologic anatomy. 3D-printed models show potential as a useful aid, allowing for physical manipulation and hands-on experience. This study investigates their educational value in teaching craniofacial pathology and surgical repair.
METHODS
Forty-four medical students randomly assigned to a control group or model group were given a PowerPoint presentation-based module on craniosynostosis and surgical repair. The model group was also provided with 3D-printed models of sagittal, metopic, and bicoronal synostosis, created using patient-specific preoperative computed tomography data. A survey using the Likert scale evaluated participants' learning experience. Pre- and postmodule scores on a 10-question multiple choice quiz were recorded.
RESULTS
The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = 0.0064), gaining an improved understanding of surgical approach (4.38 ± 0.37 versus 3.83 ± 0.29; P = 0.0266), which was more effectively taught (4.24 ± 0.33 versus 3.30 ± 0.38; P = 0.0007) with the 3D-printed models. The mean pre- and post-module quiz scores between groups were similar.
CONCLUSION
3D-printed models demonstrated an improved learning experience for medical students as shown by survey. These findings suggest a potential use for 3D-printed models in medical education of craniofacial pathology and surgery.",2020,The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = ,"['Medical Student Education in Plastic Surgery', 'Modeling Medical Education', 'Forty-four medical students']",['control group or model group were given a PowerPoint presentation-based module on craniosynostosis and surgical repair'],"['learning experience', 'mean pre- and post-module quiz scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",44.0,0.0201991,The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = ,"[{'ForeName': 'Jaina C', 'Initials': 'JC', 'LastName': 'Lane', 'Affiliation': 'Department of Plastic Surgery, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Black', 'Affiliation': ''}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006567']
2432,31567592,A novel method for ultrasound-guided radial artery cannulation in neonates by trainee anaesthesiologists: A randomised controlled trial.,"BACKGROUND
The modified dynamic needle tip positioning (MDNTP) technique for ultrasound-guided radial artery cannulation (MDNTP-US technique) in neonates can be technically challenging for trainee anaesthesiologists. We hypothesised that by associating the MDNTP-US technique with hypodermic 0.9% sodium chloride (Saline MDNTP-US technique), which increases the subcutaneous radial artery depth, the procedure would become easier for trainee anaesthesiologists.
OBJECTIVE
To compare the Saline MDNTP-US technique, with the MDNTP-US technique for radial artery catheterisation in neonates by trainee anaesthesiologists with limited experience.
DESIGN
Randomised controlled trial.
PATIENTS
Ninety-six neonates scheduled to undergo major abdominal surgery requiring continuous arterial pressure monitoring between May 2018 and December 2018 at the Children's Hospital of Chongqing Medical University were enrolled. Neonates with signs of skin erosions or haematomas at or near the insertion site, as well as those with low noninvasive blood pressure values, were excluded.
INTERVENTION
Neonates were randomised to the Saline MDNTP-US and MDNTP-US groups in a 1 : 1 ratio. Twelve trainees performed the cannulation procedures.
MAIN OUTCOME MEASURES
Duration of procedure, first attempt success rate, rate of success within 10 min, and the incidence of haematoma and thrombosis.
RESULTS
The median [IQR] time to perform cannulation was less for the Saline MDNTP-US technique than for the MDNTP-US technique: 203 [160 to 600] vs. 600 s [220 to 600]; P = 0.005. The rate of success within 10 min, 72.9 vs. 47.9%; P = 0.012, was higher in the Saline MDNTP-US group than in the MDNTP-US group. The incidence of haematoma on postoperative day 1 was lower in the Saline MDNTP-US group than in the MDNTP-US group: 8.3 vs. 22.9%; P = 0.049.
CONCLUSION
Trainee anaesthesiologists can achieve higher success rates by using the Saline MDNTP-US technique instead of the MDNTP-US technique for radial artery catheterisation in neonates, taking less time with a lower incidence of complications.
TRIAL REGISTRATION
ChiCTR-IOR-17014119 (Chinese Clinical Trial Registry).",2020,"The rate of success within 10 min, 72.9 vs. 47.9%; P = 0.012, was higher in the Saline MDNTP-US group than in the MDNTP-US group.","['neonates by trainee anaesthesiologists with limited experience', 'neonates by trainee anaesthesiologists', ""Ninety-six neonates scheduled to undergo major abdominal surgery requiring continuous arterial pressure monitoring between May 2018 and December 2018 at the Children's Hospital of Chongqing Medical University were enrolled"", 'Neonates with signs of skin erosions or haematomas at or near the insertion site, as well as those with low noninvasive blood pressure values, were excluded']","['ultrasound-guided radial artery cannulation', 'Saline MDNTP-US and MDNTP-US', 'modified dynamic needle tip positioning (MDNTP) technique for ultrasound-guided radial artery cannulation (MDNTP-US technique', 'Saline MDNTP-US technique, with the MDNTP-US technique', 'MDNTP-US technique with hypodermic 0.9% sodium chloride (Saline MDNTP-US technique', 'MDNTP-US technique']","['Duration of procedure, first attempt success rate, rate of success within 10\u200amin, and the incidence of haematoma and thrombosis', 'incidence of haematoma on postoperative day 1', 'rate of success', 'median [IQR] time to perform cannulation']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0150460', 'cui_str': 'Systemic arterial pressure monitoring (regime/therapy)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C3887524'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0449682', 'cui_str': 'Site of insertion (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}]",96.0,0.115425,"The rate of success within 10 min, 72.9 vs. 47.9%; P = 0.012, was higher in the Saline MDNTP-US group than in the MDNTP-US group.","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ye', 'Affiliation': ""From the Department of Anesthesiology, Children's Hospital of Chongqing Medical University (PY, YT, MY, SL, LB, LL), Ministry of Education Key Laboratory of Child Development and Disorders (PY, YT), Chongqing Key Laboratory of Paediatrics (PY, SL) and Chongqing International Science and Technology Cooperation Centre for Child Development and Disorders, Chongqing, PR China (PY, LB).""}, {'ForeName': 'Yanzhe', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Shangyingying', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': ''}, {'ForeName': 'Lifei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001089']
2433,31418808,Effect of Primary Care Parent-Targeted Interventions on Parent-Adolescent Communication About Sexual Behavior and Alcohol Use: A Randomized Clinical Trial.,"Importance
Adolescent well care visits provide opportunities for clinicians to facilitate parent-adolescent communication (PAC) to reduce pregnancy, sexually transmitted infections, and alcohol-related harm among adolescents.
Objective
To test the effect of brief parent-targeted interventions delivered in primary care settings on PAC about sexual and alcohol use behaviors.
Design, Setting, and Participants
Randomized clinical trial conducted at a primary care pediatric practice from January 4, 2016, to April 10, 2017. Adolescents who were scheduled for a well care visit were recruited, along with their parent or guardian. Data analyses continued through April 30, 2018.
Interventions
During well care visits, parents in sexual health intervention and alcohol prevention intervention groups received coaching to discuss written intervention materials encouraging PAC about sex or alcohol, respectively, with their adolescent within 2 weeks, followed by a brief clinician endorsement. After 2 weeks, parents received a follow-up telephone call. Control group parents received usual care.
Main Outcomes and Measures
Participants were surveyed 4 months after the well care visit. Parent-reported and adolescent-reported quality of PAC was measured using the 20-item Parent-Adolescent Communication Scale, in which a higher score indicates better PAC; and frequency of PAC about sex or alcohol was measured using a 4-point Likert-type scale with 1 indicating not at all or never, and 4 indicating a lot or often.
Results
Of 196 parent-adolescent dyads assessed for eligibility, 118 (60.2%) were eligible to participate. These 118 dyads were randomized to 1 of 3 groups: (1) sexual health intervention (n = 38 [32.2%]); (2) alcohol prevention intervention (n = 40 [33.9%]); and control (n = 40 [33.9%]); 104 parents (88.1%) and 99 adolescents (83.9%) completed the study. Parents included 112 women (94.9%) and had a mean (SD) age of 45.8 (6.9) years. Adolescents included 60 girls (50.9%); 67 adolescents (56.8%) were aged 14 years, and 51 adolescents (43.2%) were aged 15 years. Participant race/ethnicity reflected that of the practice (63 black adolescents [53.4%]; 46 white adolescents [38.9%]; 111 non-Hispanic adolescents [94.1%]). At baseline, 15 adolescents (12.7%) reported a history of sexual behavior and 16 adolescents (13.6%) reported a history of alcohol use. Intention-to-treat analyses found that 4 months after the intervention, adolescents in the sexual health intervention group reported a higher mean frequency score for PAC about sex compared with those in the control group (2.32 [95% CI, 1.97-2.66] vs 1.79 [95% CI, 1.50-2.08]; P = .02); adolescents in the alcohol prevention intervention group reported a higher mean frequency score for PAC about alcohol compared with those in the control group (2.93 [95% CI, 2.60-3.25] vs 2.40 [95% CI, 2.08-2.72]; P = .03). Parent-reported frequency scores for PAC about sex or alcohol did not differ by group.
Conclusions and Relevance
Brief parent-targeted interventions in primary care settings increased adolescent-reported frequency of PAC about sexual health and alcohol use and may be an important strategy for parents to influence adolescent behaviors and health outcomes.
Trial Registration
ClinicalTrials.gov identifier: NCT02554682.",2019,"P = .02); adolescents in the alcohol prevention intervention group reported a higher mean frequency score for PAC about alcohol compared with those in the control group (2.93 [95% CI, 2.60-3.25] vs 2.40 [95% CI, 2.08-2.72]; P = .03).","['n\u2009=\u200940 [33.9%]); and control (n\u2009=\u200940 [33.9%]); 104 parents (88.1%) and 99 adolescents (83.9%) completed the study', 'Parent-Adolescent Communication About Sexual Behavior and Alcohol Use', '196 parent-adolescent dyads assessed for eligibility, 118 (60.2%) were eligible to participate', 'primary care pediatric practice from January 4, 2016, to April 10, 2017', 'Adolescents who were scheduled for a well care visit were recruited, along with their parent or guardian', '63 black adolescents [53.4%]; 46 white adolescents [38.9%]; 111 non-Hispanic adolescents [94.1', 'Adolescents included 60 girls (50.9%); 67 adolescents (56.8%) were aged 14 years, and 51 adolescents (43.2%) were aged 15 years', '118 dyads', 'Parents included 112 women (94.9%) and had a mean (SD) age of 45.8 (6.9) years']","['coaching to discuss written intervention materials encouraging PAC about sex or alcohol', 'usual care', 'Primary Care Parent-Targeted Interventions', 'sexual health intervention', 'alcohol prevention intervention']","['quality of PAC', 'mean frequency score for PAC about sex', 'history of alcohol use', 'mean frequency score for PAC about alcohol', 'history of sexual behavior']","[{'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",60.0,0.0649916,"P = .02); adolescents in the alcohol prevention intervention group reported a higher mean frequency score for PAC about alcohol compared with those in the control group (2.93 [95% CI, 2.60-3.25] vs 2.40 [95% CI, 2.08-2.72]; P = .03).","[{'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Ford', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'Jessica H', 'Initials': 'JH', 'LastName': 'Mirman', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'J Felipe', 'Initials': 'JF', 'LastName': 'García-España', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Fisher Thiel', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Friedrich', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'Elyse C', 'Initials': 'EC', 'LastName': 'Salek', 'Affiliation': ""Perelman School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jaccard', 'Affiliation': 'Silver School of Social Work, New York University, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9535']
2434,31433479,Patient Perspectives About Decisions to Share Medical Data and Biospecimens for Research.,"Importance
Patients increasingly demand transparency in and control of how their medical records and biospecimens are shared for research. How much they are willing to share and what factors influence their sharing preferences remain understudied in real settings.
Objectives
To examine whether and how various presentations of consent forms are associated with differences in electronic health record and biospecimen sharing rates and whether these rates vary according to user interface design, data recipients, data and biospecimen items, and patient characteristics.
Design, Setting, and Participants
For this survey study, a data and biospecimen sharing preference survey was conducted at 2 academic hospitals from May 1, 2017, to September 31, 2018, after simple randomization of patients to 1 of 4 options with different layout and formats of indicating sharing preferences: opt-in simple, opt-in detailed, opt-out simple, and opt-out detailed.
Interventions
All participants were presented with a list of data and biospecimen items that could be shared for research within the same health care organization or with other nonprofit or for-profit institutions. Participating patients were randomly asked to select the items that they would share (opt-in) or were asked to select items they would not share (opt-out). Patients in these 2 groups were further randomized to select only among 18 categories vs 59 detailed items (simple vs detailed form layout).
Main Outcomes and Measures
The primary end points were the percentages of patients willing to share data and biospecimen categories or items.
Results
Among 1800 eligible participants, 1246 (69.2%) who completed their data sharing survey were included in the analysis, and 850 of these patients (mean [SD] age, 51.1 [16.7] years; 507 [59.6%] female; 677 [79.6%] white) responded to the satisfaction survey. A total of 46 participants (3.7%) declined sharing with the home institution, 352 (28.3%) with nonprofit institutions, and 590 (47.4%) with for-profit institutions. A total of 836 (67.1%) indicated that they would share all items with researchers from the home institution. When comparing opt-out with opt-in interfaces, all 59 sharing choice variables (100%) were associated with the sharing decision. When comparing simple with detailed forms, only 14 variables (23.7%) were associated with the sharing decision.
Conclusions and Relevance
The findings suggest that most patients are willing to share their data and biospecimens for research. Allowing patients to decide with whom they want to share certain types of data may affect research that involves secondary use of electronic health records and/or biosamples for research.",2019,"When comparing simple with detailed forms, only 14 variables (23.7%) were associated with the sharing decision.
","['A total of 46 participants (3.7%) declined sharing with the home institution, 352 (28.3%) with nonprofit institutions, and 590 (47.4%) with for-profit institutions', 'Participants\n\n\nFor this survey study, a data and biospecimen sharing preference survey was conducted at 2 academic hospitals from May 1, 2017, to September 31, 2018, after simple randomization of patients to 1 of 4 options with different', '1800 eligible participants, 1246 (69.2%) who completed their data sharing survey were included in the analysis, and 850 of these patients (mean [SD] age, 51.1 [16.7] years; 507 [59.6%] female; 677 [79.6%] white) responded to the satisfaction survey', 'All participants were presented with a list of data and biospecimen items that could be shared for research within the same health care organization or with other nonprofit or for-profit institutions']","['layout and formats of indicating sharing preferences: opt-in simple, opt-in detailed, opt-out simple, and opt-out detailed']",['percentages of patients willing to share data and biospecimen categories or items'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2713450', 'cui_str': 'Data Sharing'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0220885', 'cui_str': 'organization'}]","[{'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}]",1800.0,0.0327228,"When comparing simple with detailed forms, only 14 variables (23.7%) were associated with the sharing decision.
","[{'ForeName': 'Jihoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Informatics, UC San Diego Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Hyeoneui', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'School of Nursing, Duke University, Durham, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bell', 'Affiliation': 'Office of Graduate Studies and Research, California State University, San Marcos.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bath', 'Affiliation': 'Department of Biomedical Informatics, UC San Diego Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Paul', 'Affiliation': 'Department of Biomedical Informatics, UC San Diego Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Pham', 'Affiliation': 'Department of Biomedical Informatics, UC San Diego Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'School of Biomedical Informatics, University of Texas Health Science Center, Houston.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': 'Department of Informatics, University of California, Irvine.'}, {'ForeName': 'Lucila', 'Initials': 'L', 'LastName': 'Ohno-Machado', 'Affiliation': 'Department of Biomedical Informatics, UC San Diego Health, University of California, San Diego, La Jolla.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9550']
2435,31492652,"Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial.","BACKGROUND
Ozanimod is a sphingosine 1-phosphate receptor modulator, which selectively binds to sphingosine 1-phosphate receptor subtypes 1 and 5 with high affinity. In the RADIANCE phase 2 study in participants with relapsing multiple sclerosis, ozanimod was associated with better efficacy than placebo on MRI measures and was well tolerated. The RADIANCE phase 3 study aimed to confirm the safety and efficacy of ozanimod versus interferon beta-1a in individuals with relapsing multiple sclerosis.
METHODS
We did a 24-month, multicentre, double-blind, double-dummy phase 3 trial in participants with relapsing multiple sclerosis at 147 medical centres and clinical practices in 21 countries. Participants were aged 18-55 years, had multiple sclerosis according to 2010 McDonald criteria, a relapsing clinical course, brain MRI lesions consistent with multiple sclerosis, an expanded disability status scale score of 0·0-5·0, and either at least one relapse within 12 months before screening or at least one relapse within 24 months before screening plus at least one gadolinium-enhancing lesion within the 12 months before randomisation. Participants were randomly assigned (1:1:1) via an interactive voice response system to daily oral ozanimod 1·0 mg or 0·5 mg or weekly intramuscular interferon beta-1a 30 μg. Participants, investigators, and study staff were masked to treatment allocation. The primary endpoint was annualised relapse rate (ARR) over 24 months. The primary analysis was done in the intention-to-treat population of all participants who received study drug and safety was assessed in all randomly assigned participants who received study drug, grouped by highest dose of ozanimod received. This trial is registered at ClinicalTrials.gov, NCT02047734, and EudraCT, 2012-002714-40.
FINDINGS
Between Dec 27, 2013, and March 31, 2015, we screened 1695 participants, of which 375 did not meet inclusion criteria. 1320 participants were enrolled and randomly assigned to a group, of whom 1313 received study drug (433 assigned to ozanimod 1·0 mg, 439 assigned to ozanimod 0·5 mg, and 441 assigned to interferon beta-1a) and 1138 (86·7%) completed 24 months of treatment. Adjusted ARRs were 0·17 (95% CI 0·14-0·21) with ozanimod 1·0 mg, 0·22 (0·18-0·26) with ozanimod 0·5 mg, and 0·28 (0·23-0·32) with interferon beta-1a, with rate ratios versus interferon beta-1a of 0·62 (95% CI 0·51-0·77; p<0·0001) for ozanimod 1·0 mg and 0·79 (0·65 to 0·96; p=0·0167) for ozanimod 0·5 mg. The incidence of treatment-emergent adverse events was higher in the interferon beta-1a group (365 [83·0%] of 440 participants) than in the ozanimod 1·0 mg group (324 [74·7%] of 434) or the ozanimod 0·5 mg group (326 [74·3%] of 439). More participants in the interferon beta-1a group had treatment-emergent adverse events leading to treatment discontinuation than in the ozanimod groups. Incidences of infections and serious treatment-emergent adverse events were similar across treatment groups. No cases of ozanimod-related symptomatic reduction in heart rate and no second-degree or third-degree cases of atrioventricular block were reported.
INTERPRETATION
In this 24-month phase 3 study in participants with relapsing multiple sclerosis, ozanimod was well tolerated and associated with a significantly lower rate of clinical relapses than intramuscular interferon beta-1a. These findings show the potential of ozanimod as an effective oral therapy for individuals with relapsing multiple sclerosis.
FUNDING
Celgene International II.",2019,"Adjusted ARRs were 0·17 (95% CI 0·14-0·21) with ozanimod 1·0 mg, 0·22 (0·18-0·26) with ozanimod 0·5 mg, and 0·28","['participants with relapsing multiple sclerosis', '1320 participants', 'individuals with relapsing multiple sclerosis', '1695 participants, of which 375 did not meet inclusion criteria', '2012-002714-40', 'Participants were aged 18-55 years, had multiple sclerosis according to 2010 McDonald criteria, a relapsing clinical course, brain MRI lesions consistent with multiple sclerosis, an expanded disability status scale score of 0·0-5·0, and either at least one relapse within 12 months before screening or at least one relapse within 24 months before screening plus at least one gadolinium-enhancing lesion within the 12 months before randomisation', 'participants with relapsing multiple sclerosis at 147 medical centres and clinical practices in 21 countries']","['interactive voice response system to daily oral ozanimod 1·0 mg or 0·5 mg or weekly intramuscular interferon beta-1a 30 μg', 'placebo', 'ozanimod', 'ozanimod 0·5', 'ozanimod 1·0 mg, 439 assigned to ozanimod 0·5 mg, and 441 assigned to interferon beta-1a', 'interferon']","['tolerated', 'MRI measures', 'Safety and efficacy', 'incidence of treatment-emergent adverse events', 'annualised relapse rate (ARR', 'rate of clinical relapses', 'treatment-emergent adverse events', 'Incidences of infections and serious treatment-emergent adverse events', 'safety and efficacy']","[{'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0449259', 'cui_str': 'Clinical course (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",1320.0,0.215109,"Adjusted ARRs were 0·17 (95% CI 0·14-0·21) with ozanimod 1·0 mg, 0·22 (0·18-0·26) with ozanimod 0·5 mg, and 0·28","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cohen', 'Affiliation': 'Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA. Electronic address: cohenj@ccf.org.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Krzysztof W', 'Initials': 'KW', 'LastName': 'Selmaj', 'Affiliation': 'Center for Neurology, Lodz, Poland; Collegium Medicum, Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'Center for Neuroinflammation and Experimental Therapeutics, and Multiple Sclerosis Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'NeuroRx Research and Montréal Neurological Institute, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Steinman', 'Affiliation': 'Department of Neurology and Neurological Sciences, Beckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine University, Dusseldorf, Germany.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Division of Neurology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada; Department of Neurology-Neuroimmunology, and Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kubala Havrdová', 'Affiliation': 'Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Sheffield', 'Affiliation': 'Department of Clinical Development, Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Minton', 'Affiliation': 'Drug Safety, Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Raghupathi', 'Affiliation': 'Department of Biostatistics, Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, University Hospital and University of Basel, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30238-8']
2436,31493013,"The effect of balneotherapy and peloid therapy on changes in the functional state of patients with knee joint osteoarthritis: a randomized, controlled, single-blind pilot study.","The treatment of OA using pharmaceutical and non-pharmaceutical measures remains a topical subject. The purpose of this study is to assess the effect of natural factors (mineral water and mud) on changes in the functional state of patients with knee joint OA. Ninety-two adult people with grade I-III knee joint OA according to the Kellgren and Lawrence scoring system participated in the study. The subjects received 10 mineral water bath plus physical therapy or mud application procedures plus physical therapy or physical therapy alone every other day. The effectiveness of the treatment was assessed on the basis of anthropometric changes of data, VAS, SF-36, KOOS questionnaire indicators. Significantly greater walking speed, test of 5 sit downs/stand ups, circumference of a knee joint, flexion and extension range, flexor and extensor strength after treatment lasting 1 month were obtained in the intervention group. After 1 month after treatment pain intensity scores over the past month and when changing position were significantly higher in the control group. The positive changes in SF-36 were identified after 1 month after treatment: physical activity increased and pain decreased in the intervention groups. There was no significant difference between the averages of any KOOS subscale in groups. However, average percentages of symptoms, stiffness, and pain in the intervention groups were significantly better after treatment and lasting 1 month after treatment. Balneotherapy and peloid therapy effectively reduce pain and improve the functional state of patients with OA of a knee joint.",2020,After 1 month after treatment pain intensity scores over the past month and when changing position were significantly higher in the control group.,"['patients with knee joint OA', 'patients with OA of a knee joint', 'Ninety-two adult people with grade I-III knee joint OA according to the Kellgren and Lawrence scoring system participated in the study', 'patients with knee joint osteoarthritis']","['natural factors (mineral water and mud', 'balneotherapy and peloid therapy', '10 mineral water bath plus physical therapy or mud application procedures plus physical therapy or physical therapy alone every other day', 'Balneotherapy and peloid therapy']","['KOOS subscale', 'anthropometric changes of data, VAS, SF-36, KOOS questionnaire indicators', 'average percentages of symptoms, stiffness, and pain', 'functional state', 'pain intensity scores', 'pain', 'walking speed, test of 5 sit downs/stand ups, circumference of a knee joint, flexion and extension range, flexor and extensor strength', 'physical activity increased and pain', 'positive changes in SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0085867', 'cui_str': 'Balneotherapy'}, {'cui': 'C0026729', 'cui_str': 'Peloid Therapy'}, {'cui': 'C0150141'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0585841', 'cui_str': 'Application procedure (administrative) (procedure)'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0560831', 'cui_str': 'Does sit down (finding)'}, {'cui': 'C0444796', 'cui_str': 'Standing up (observable entity)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",92.0,0.0179924,After 1 month after treatment pain intensity scores over the past month and when changing position were significantly higher in the control group.,"[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Varzaityte', 'Affiliation': 'Department of Rehabilitation, Lithuanian University of Health Sciences, A. Mickevičiaus str. 9, LT-44307, Kaunas, Lithuania. lina.varzaityte@gmail.com.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Rehabilitation, Lithuanian University of Health Sciences, A. Mickevičiaus str. 9, LT-44307, Kaunas, Lithuania.'}, {'ForeName': 'Lolita', 'Initials': 'L', 'LastName': 'Rapoliene', 'Affiliation': 'Department of Nursing, Klaipeda University, H. Mantas str. 84, LT-92294, Klaipėda, Lithuania.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Bartuseviciute', 'Affiliation': 'Limited company Medical SPA Eglės Sanatorija, Eglės str. 1, LT-66251, Druskininkai, Lithuania.'}, {'ForeName': 'Arvydas', 'Initials': 'A', 'LastName': 'Balcius', 'Affiliation': 'Limited company Medical SPA Eglės Sanatorija, Eglės str. 1, LT-66251, Druskininkai, Lithuania.'}, {'ForeName': 'Kestutis', 'Initials': 'K', 'LastName': 'Ramanauskas', 'Affiliation': 'Druskininkai Recreation and Health Centre, Vilniaus av. 11, LT-66119, Druskininkai, Lithuania.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Nedzelskiene', 'Affiliation': 'Department of Dental and Oral Pathology, Lithuanian University of Health Sciences, Mickevičiaus str. 9, LT-44307, Kaunas, Lithuania.'}]",International journal of biometeorology,['10.1007/s00484-019-01785-z']
2437,30561610,Persistent arterial wall inflammation in patients with elevated lipoprotein(a) despite strong low-density lipoprotein cholesterol reduction by proprotein convertase subtilisin/kexin type 9 antibody treatment.,"AIMS
Subjects with lipoprotein(a) [Lp(a)] elevation have increased arterial wall inflammation and cardiovascular risk. In patients at increased cardiovascular risk, arterial wall inflammation is reduced following lipid-lowering therapy by statin treatment or lipoprotein apheresis. However, it is unknown whether lipid-lowering treatment in elevated Lp(a) subjects alters arterial wall inflammation. We evaluated whether evolocumab, which lowers both low-density lipoprotein cholesterol (LDL-C) and Lp(a), attenuates arterial wall inflammation in patients with elevated Lp(a).
METHODS AND RESULTS
In this multicentre, randomized, double-blind, placebo-controlled study, 129 patients {median [interquartile range (IQR)]: age 60.0 [54.0-67.0] years, Lp(a) 200.0 [155.5-301.5] nmol/L [80.0 (62.5-121.0) mg/dL]; mean [standard deviation (SD)] LDL-C 3.7 [1.0] mmol/L [144.0 (39.7) mg/dL]; National Cholesterol Education Program high risk, 25.6%} were randomized to monthly subcutaneous evolocumab 420 mg or placebo. Compared with placebo, evolocumab reduced LDL-C by 60.7% [95% confidence interval (CI) 65.8-55.5] and Lp(a) by 13.9% (95% CI 19.3-8.5). Among evolocumab-treated patients, the Week 16 mean (SD) LDL-C level was 1.6 (0.7) mmol/L [60.1 (28.1) mg/dL], and the median (IQR) Lp(a) level was 188.0 (140.0-268.0) nmol/L [75.2 (56.0-107.2) mg/dL]. Arterial wall inflammation [most diseased segment target-to-background ratio (MDS TBR)] in the index vessel (left carotid, right carotid, or thoracic aorta) was assessed by 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography. Week 16 index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%) [treatment difference -3.0% (95% CI -7.4% to 1.4%); P = 0.18].
CONCLUSION
Evolocumab treatment in patients with median baseline Lp(a) 200.0 nmol/L led to a large reduction in LDL-C and a small reduction in Lp(a), resulting in persistent elevated Lp(a) levels. The latter may have contributed to the unaltered arterial wall inflammation.",2019,index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%),"['patients with median baseline Lp(a', '129 patients {median [interquartile range (IQR)]: age 60.0 [54.0-67.0] years, Lp(a) 200.0', 'Aims\n\n\nSubjects with lipoprotein(a) [Lp(a', 'patients with elevated lipoprotein(a', 'patients with elevated Lp(a']","['subcutaneous evolocumab 420\u2009mg or placebo', 'dL', 'placebo']","['cardiovascular risk, arterial wall inflammation', 'index vessel MDS TBR', 'arterial wall inflammation and cardiovascular risk', 'mean (SD) LDL-C level', 'low-density lipoprotein cholesterol (LDL-C) and Lp(a', 'median (IQR) Lp(a) level', 'Arterial wall inflammation [most diseased segment target-to-background ratio (MDS TBR', 'LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0507850', 'cui_str': 'Structure of wall of artery (body structure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",129.0,0.615669,index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%),"[{'ForeName': 'Lotte C A', 'Initials': 'LCA', 'LastName': 'Stiekema', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Simone L', 'Initials': 'SL', 'LastName': 'Verweij', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Helina', 'Initials': 'H', 'LastName': 'Kassahun', 'Affiliation': 'Department of Clinical Development, Amgen Inc., One Amgen Center Drive Thousand Oaks, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Amgen Inc., One Amgen Center Drive Thousand Oaks, CA, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wasserman', 'Affiliation': 'Department of Clinical Development, Amgen Inc., One Amgen Center Drive Thousand Oaks, CA, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School, Fenwood Road, Boston, MA, USA.""}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Mani', 'Affiliation': 'Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Pl, New York, NY, USA.'}, {'ForeName': 'Zahi A', 'Initials': 'ZA', 'LastName': 'Fayad', 'Affiliation': 'Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Pl, New York, NY, USA.'}]",European heart journal,['10.1093/eurheartj/ehy862']
2438,14974655,Octylcyanoacrylate skin closure in laparoscopy.,"OBJECTIVES
Octylcyanoacrylate (Dermabond) is a dermal bond useful in closing surgical skin incisions. We compared skin octylcyanoacrylate with subcuticular skin sutures to close laparoscopic trocar sites.
METHODS
A randomized, double-armed, prospective study was performed with 59 patients, in whom 228 trocar sites were closed. Twenty-nine patients underwent subcuticular closure of laparoscopic incisions, and 30 patients received closure with octylcyanoacrylate. Sutured trocar sites were closed with subcuticular 4-0 absorable suture. Octylcyanoacrylate wounds received closure in accordance with the recommendations of the manufacturer (Ethicon, Somerville, NJ). The number of sutures or vials of octylcyanoacrylate used, closure times, and postoperative wound problems were recorded. Wounds were assessed 2 weeks postoperatively for healing complications. Closure costs were estimated using published operating room time per hour plus the cost of octylcyanoacrylate or suture. The Student paired t test was used for statistical analysis.
RESULTS
The overall mean time for skin closure using octylcyanoacrylate and suture was 3.7 minutes and 14 minutes, respectively (P<0.00001). An average of 2.2 packets of suture were used to close all port sites, while those closed with octylcyanoacrylate required an average of 3.4 vials per patient. Wound complications consisted of subcuticular seroma with skin separation. No difference was noted in complication rates between the 2 groups. Overall average cost per closure using octylcyanoacrylate was 198 dollars while cost for closure using suture was 497 dollars (P<0.00001).
CONCLUSIONS
Laparoscopic port-site skin closure with octylcyanoacrylate is rapid and effective. Closure with octylcyanoacrylate yields cost savings and a decrease in operative time of more than 9 minutes per case.",2004,Closure with octylcyanoacrylate yields cost savings and a decrease in operative time of more than 9 minutes per case.,"['59 patients, in whom 228 trocar sites were closed']","['closure with octylcyanoacrylate', 'skin octylcyanoacrylate with subcuticular skin sutures', 'Octylcyanoacrylate skin closure in laparoscopy', 'subcuticular seroma with skin separation', 'subcuticular closure of laparoscopic incisions', 'Sutured trocar sites were closed with subcuticular 4-0 absorable suture']","['overall mean time for skin closure', 'number of sutures or vials of octylcyanoacrylate used, closure times, and postoperative wound problems', 'Closure costs', 'operative time', 'healing complications', 'complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}]","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0767652', 'cui_str': 'octylcyanoacrylate'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0457280', 'cui_str': 'Number of sutures (qualifier value)'}, {'cui': 'C1706398', 'cui_str': 'Vil'}, {'cui': 'C0767652', 'cui_str': 'octylcyanoacrylate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0285555,Closure with octylcyanoacrylate yields cost savings and a decrease in operative time of more than 9 minutes per case.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sebesta', 'Affiliation': 'Wilford Hall Medical Center, Lackland AFB, Texas 78326, USA.'}, {'ForeName': 'Jay T', 'Initials': 'JT', 'LastName': 'Bishoff', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2439,14974656,Preemptive analgesia does not reduce pain or improve postoperative functioning.,"OBJECTIVES
To examine the effectiveness of preemptive analgesia in gynecologic laparoscopy patients.
METHODS
A double-blinded, randomized trial was performed from June 2000 to June 2001. Preoperatively, patients were randomly assigned to 0.25% bupivicaine or normal saline control. Following anesthetic induction, the study drug or a placebo was injected prior to the proposed incisions.
RESULTS
Of the 164 patients enrolled, 85 were randomized to the study group and 79 to the control. Age, surgery indication, and estimated blood loss did not vary significantly between groups. Overall mean pain score (+/-standard error of the mean) for study and control groups did not differ at 4 hours (3.2+/-0.3 vs 3.2+/-0.3) or at 24 hours (4.2+/-0.3 vs 4.2+/-0.3). Incisional pain scores also did not differ at 4 hours (3.0+/-0.3 vs 2.7+/-0.3) or at 24 hours (3.6+/-0.3 vs 3.6+/-0.3). Both groups were similar in activity limitation at 24 hours and oral narcotic consumption within 24 hours postoperatively. After stratifying surgery type for level of complexity, no difference was noted between groups. Multiple logistic regression analysis also noted no difference in outcomes.
CONCLUSION
Preemptive analgesia in patients undergoing gynecologic laparoscopy does not reduce postoperative pain or decrease the time to return of normal activities.",2004,Preemptive analgesia in patients undergoing gynecologic laparoscopy does not reduce postoperative pain or decrease the time to return of normal activities.,"['patients undergoing', 'gynecologic laparoscopy patients', 'June 2000 to June 2001', '164 patients enrolled, 85 were randomized to the study group and 79 to the control']","['gynecologic laparoscopy', 'placebo', 'preemptive analgesia', 'Preemptive analgesia', 'bupivicaine or normal saline control']","['pain or improve postoperative functioning', 'time to return of normal activities', 'blood loss', 'Incisional pain scores', 'postoperative pain', 'activity limitation', 'Overall mean pain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",164.0,0.332564,Preemptive analgesia in patients undergoing gynecologic laparoscopy does not reduce postoperative pain or decrease the time to return of normal activities.,"[{'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Grube', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University Medical School, Chicago, Illinois, USA.'}, {'ForeName': 'Magdy P', 'Initials': 'MP', 'LastName': 'Milad', 'Affiliation': ''}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Damme-Sorenen', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2440,31494096,"Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study.","BACKGROUND
Interleukin 15 (IL-15) is implicated in the pathophysiology of coeliac disease. AMG 714 is the first anti-IL-15 monoclonal antibody to be investigated for the treatment of coeliac disease. We aimed to investigate the effects of AMG 714 in patients with coeliac disease who underwent gluten challenge.
METHODS
This randomised, double-blind, placebo-controlled, parallel-group, phase 2a trial was done at three clinical sites in Finland. Inclusion criteria included age 18-80 years, a confirmed diagnosis of coeliac disease, and adherence to a gluten-free diet for at least 12 months before screening. Patients were randomly assigned (1:1:1) to 150 mg AMG 714, 300 mg AMG 714, or placebo using permuted blocks and stratified by study site and sex. Patients and study staff were masked to treatment assignment. Treatments were administered by two subcutaneous injections every 2 weeks for 10 weeks (total six doses). Patients without severe villous atrophy at baseline received a gluten challenge (2-4 g daily) during weeks 2-12. Small bowel biopsy samples were obtained for histological assessments at baseline and week 12. The primary efficacy endpoint was the percentage change from baseline to week 12 in villous height-to-crypt depth (VHCD) ratio. Secondary endpoints were CD3-positive intraepithelial lymphocyte density; clinical symptoms measured by gastrointestinal symptom rating scale (GSRS), coeliac disease GSRS, and Bristol stool form scale (BSFS); and changes in anti-tTG and anti-DGP antibodies from baseline. The primary analysis was done in the per-protocol 1 population of patients who received at least one dose of study drug and who underwent the gluten challenge. Safety analyses were done in all patients who received at least one dose of study drug. This trial is registered at ClinicalTrials.gov, NCT02637141 and EudraCT, 2015-003647-19.
FINDINGS
Between April 13, 2016, and Nov 22, 2016, 64 patients were enrolled and randomly assigned to either the 150 mg AMG 714 group (n=22), the 300 mg AMG 714 group (n=22), or the placebo group (n=20). Two patients did not start treatment and two did not provide post-treatment biopsy samples. 49 patients underwent the gluten challenge (per-protocol 1 population) and 11 patients did not because of baseline villous atrophy. AMG 714 did not prevent mucosal injury due to gluten challenge. The least square mean difference in the relative change from baseline in VHCD ratio was -2·49% (95% CI -16·82 to 11·83; p=0·73) between 150 mg AMG 714 and placebo and 6·39% (-7·07 to 19·85; p=0·34) between 300 mg AMG 714 and placebo. Neither comparison was statistically significant. The density of CD3-positive intraepithelial lymphocytes increased in all groups, with smaller increases in the 300 mg group (-41·24% [95% CI -79·28 to -3·20] vs placebo, nominal p=0·03) but not the 150 mg group (-14·32% [-54·39 to 25·74], nominal p=0·47). Clinical symptoms were ameliorated with AMG 714 treatment between baseline and week 12, particularly diarrhoea as measured by the BSFS (nominal p=0·01 for 150 mg vs placebo, and nominal p=0·0002 for 300 mg vs placebo). Serum antibody titres for anti-tTG and anti-DGP antibodies increased in all three treatment groups, with no significant difference between AMG 714 and placebo. Treatment-emergent adverse events occurred in 21 (95%) patients in the 150 mg AMG 714 group, 0 (95%) in the 300 mg AMG 714 group, and 19 (100%) in the placebo group. The most common treatment-emergent adverse events were gastrointestinal disorders (17 [77%] participants in the 150 mg AMG 714 group, 16 [76%] in the 300 mg AMG 714 group, and 13 [68%] in the placebo group). Injection site reactions were the most common individual adverse event, reported in eight (36%) patients in the 150 mg AMG 714 group, 11 (52%) in the 300 mg group, and five (26%) in the placebo group. No serious adverse events occurred.
INTERPRETATION
The primary endpoint, change in VHCD ratio from baseline after 12 weeks of treatment in patients with coeliac disease undergoing gluten challenge, was not significantly different between placebo and AMG 714 at either 150 mg or 300 mg. Effects on intraepithelial lymphocyte density and symptoms suggest that further research of AMG 714 may be warranted in patients with non-responsive coeliac disease.
FUNDING
Celimmune and Amgen.",2019,"The density of CD3-positive intraepithelial lymphocytes increased in all groups, with smaller increases in the 300 mg group (-41·24% [95% CI -79·28 to -3·20] vs placebo, nominal p=0·03) but not the 150 mg group (-14·32% [-54·39 to 25·74], nominal p=0·47).","['Inclusion criteria included age 18-80 years, a confirmed diagnosis of coeliac disease, and adherence to a gluten-free diet for at least 12 months before screening', 'patients with non-responsive coeliac disease', 'Between April 13, 2016, and Nov 22, 2016, 64 patients', 'adults with coeliac disease exposed to gluten challenge', '49 patients underwent the gluten challenge (per-protocol 1 population) and 11 patients did not because of baseline villous atrophy', 'patients with coeliac disease who underwent gluten challenge']","['placebo', 'AMG', 'AMG 714, 300 mg AMG 714, or placebo']","['Small bowel biopsy samples', 'adverse events', 'VHCD ratio', 'diarrhoea', 'percentage change from baseline to week 12 in villous height-to-crypt depth (VHCD) ratio', 'severe villous atrophy', 'Safety and efficacy', 'CD3-positive intraepithelial lymphocyte density; clinical symptoms measured by gastrointestinal symptom rating scale (GSRS), coeliac disease GSRS, and Bristol stool form scale (BSFS); and changes in anti-tTG and anti-DGP antibodies', 'Serum antibody titres for anti-tTG and anti-DGP antibodies', 'change in VHCD ratio', 'Clinical symptoms', 'density of CD3-positive intraepithelial lymphocytes', 'gastrointestinal disorders']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0554101', 'cui_str': 'Villous atrophy (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample (specimen)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0554101', 'cui_str': 'Villous atrophy (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1512944', 'cui_str': 'Intraepithelial T Cells'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}]",714.0,0.486434,"The density of CD3-positive intraepithelial lymphocytes increased in all groups, with smaller increases in the 300 mg group (-41·24% [95% CI -79·28 to -3·20] vs placebo, nominal p=0·03) but not the 150 mg group (-14·32% [-54·39 to 25·74], nominal p=0·47).","[{'ForeName': 'Marja-Leena', 'Initials': 'ML', 'LastName': 'Lähdeaho', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'Clinical Research Services Turku, Turku, Finland; Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Vuotikka', 'Affiliation': 'Institute of Biomedicine, University of Turku, Terveystalo, Oulu, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Taavela', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland; Department of Internal Medicine, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Popp', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland; University of Medicine and Pharmacy ""Carol Davila"", Bucharest, Romania.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Laukkarinen', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Koffert', 'Affiliation': 'Department of Gastroenterology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Olli-Pekka', 'Initials': 'OP', 'LastName': 'Koivurova', 'Affiliation': 'Institute of Biomedicine, University of Turku, Terveystalo, Oulu, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Pesu', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kivelä', 'Affiliation': 'Tampere Center for Child Health Research, Tampere University and University Hospital, Tampere, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'Clinical Research Services Turku, Turku, Finland.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Keisala', 'Affiliation': 'Institute of Biomedicine, University of Turku, Terveystalo, Oulu, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Isola', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland; Tampere Center for Child Health Research, Tampere University and University Hospital, Jilab, Tampere, Finland.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Parnes', 'Affiliation': 'Tampere Center for Child Health Research, Tampere University and University Hospital, Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Leon', 'Affiliation': 'Tampere Center for Child Health Research, Tampere University and University Hospital, Celimmune, Bethesda, MD, USA; Tampere Center for Child Health Research, Tampere University and University Hospital, Provention Bio, Oldwick, NJ, USA. Electronic address: fleon@proventionbio.com.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Mäki', 'Affiliation': 'Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technologies, Tampere University, Tampere, Finland.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30264-X']
2441,32494981,Comparison of S-1-cisplatin every 5 weeks with capecitabine-cisplatin every 3 weeks for HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced): pooled analysis of HERBIS-2 (OGSG 1103) and HERBIS-4A (OGSG 1105) trials.,"BACKGROUND
We previously reported the HERBIS-4A phase II trial comparing S-1 plus cisplatin (SP) with capecitabine plus cisplatin (XP) in chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC). We performed a pooled analysis of HERBIS-4A and HERBIS-2, the phase II trial comparing SP with XP in HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of ≥ 6 months.
PATIENTS AND METHODS
Patients were randomly assigned to receive either SP [S-1 (40-60 mg twice daily for 21 days) plus cisplatin (60 mg/m 2 on day 8), every 5 weeks] or XP [capecitabine (1000 mg/m 2 twice daily for 14 days) plus cisplatin (80 mg/m 2 on day 1), every 3 weeks].
RESULTS
In the pooled analysis, SP (n = 44-50) showed a longer progression-free survival [6.4 versus 5.1 months; hazard ratio (HR), 0.666; P = 0.062], overall survival (14.8 versus 10.6 months; HR, 0.695; P = 0.099), and time to treatment failure (4.6 versus 3.6 months; HR, 0.668; P = 0.045) as well as a higher disease control rate (86.4% versus 68.1%, P = 0.149) compared with XP (n = 47-51). A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.
CONCLUSION
Our pooled analysis supports the use of SP in the first-line setting for patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of ≥ 6 months.
CLINICAL TRIAL REGISTRATION
The HERBIS-2 trial was registered with UMIN-CTR as UMIN000006105.",2020,"A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.
","['HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of\u2009≥\u20096\xa0months', 'Patients', 'chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC', 'HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced', 'patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of\u2009≥\u20096\xa0months']","['S-1 plus cisplatin (SP) with\xa0capecitabine plus cisplatin (XP', 'XP', 'S-1-cisplatin', 'capecitabine-cisplatin', 'SP [S-1', 'cisplatin', 'XP [capecitabine']","['time to treatment failure', 'longer progression-free survival', 'overall survival', 'disease control rate']","[{'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.153097,"A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.
","[{'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, 377-2 Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan. kawakami_h@med.kindai.ac.jp.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka Prefectural General Medical Center, Osaka-shi, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Akamaru', 'Affiliation': 'Department of Surgery, Ikeda Municipal Hospital, Ikeda, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Endo', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Kindai University, Osaka-sayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Sakai, Japan.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Makari', 'Affiliation': 'Department of Medical Oncology, Kindai University Nara Hospital, Ikoma, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Cancer Center, Izumi City General Hospital, Izumi, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Tsujinaka', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical oncology,['10.1007/s10147-020-01711-z']
2442,31418805,Effect of Bismuth Subsalicylate vs Placebo on Use of Antibiotics Among Adult Outpatients With Diarrhea in Pakistan: A Randomized Clinical Trial.,"Importance
Many of the 4.5 billion annual episodes of diarrhea are treated unnecessarily with antibiotics; prevalence of antibiotic resistance among diarrheal pathogens is increasing. Knowledge-based antibiotic stewardship interventions typically yield little change in antibiotic use.
Objective
To compare antibiotic use among adult outpatients with diarrhea given bismuth subsalicylate (BSS) or placebo.
Design, Setting, and Participants
This randomized clinical trial took place from April to October 2014. Participants were patients aged 15 to 65 years with acute, nonbloody diarrhea from 22 outpatient clinics in Karachi, Pakistan. Participants were interviewed about symptoms and health care utilization during the 5 days after enrollment. Group assignment was concealed from participants, field staff, and the statistician. Primary analysis occurred from August to September 2015.
Interventions
Participants were randomly assigned (1:1) to receive BSS or placebo for 48 hours or less.
Main Outcomes and Measures
Use of systemic antibiotics within 5 days of enrollment. Secondary outcomes included measures of duration and severity of illness.
Results
Among eligible patients, 39 declined to participate, 440 enrolled, and 1 enrolled participant was lost to follow-up, for a total of 439 patients included in the analysis. Median (interquartile range) participant age was 32 (23-45) years and 187 (43%) were male. Two hundred twenty patients were randomized to BSS and 220 were randomized to placebo. Overall, 54 participants (12%) used systemic antibiotics (16% in the placebo group and 9% in the BSS group); all antibiotic use followed consultation with a physician. Use of any antibiotic was significantly lower in the BSS group (20 of 220 vs 34 of 219 patients; odds ratio [OR], 0.54; 95% CI, 0.30-0.98), as was use of fluoroquinolones (8 of 220 vs 20 of 219 patients; OR, 0.38; 95% CI, 0.16-0.88). Rates of care seeking and hospitalization were similar between groups and no difference was detected in timing of diarrhea resolution. However, those in the BSS group less commonly received intravenous rehydration (14 of 220 vs 27 of 219 patients; OR, 0.48; 95% CI, 0.25-0.95) and missed less work (median [interquartile range], 0 [0-1] vs 1 [0-1] day; P = .04) during follow-up.
Conclusions and Relevance
This study found less antibiotic use among participants given BSS for acute diarrhea in a setting where antibiotics are commonly used to treat diarrhea. Encouraging health care professionals in such settings to recommend BSS as frontline treatment for adults with diarrhea, and promoting BSS for diarrhea self-management, may reduce antibiotic use and rates of antibiotic resistance globally.
Trial Registration
ClinicalTrials.gov identifier: NCT02047162.",2019,"Use of any antibiotic was significantly lower in the BSS group (20 of 220 vs 34 of 219 patients; odds ratio [OR], 0.54; 95% CI, 0.30-0.98), as was use of fluoroquinolones (8 of 220 vs 20 of 219 patients; OR, 0.38; 95% CI, 0.16-0.88).","['Adult Outpatients With Diarrhea in Pakistan', 'Median (interquartile range) participant age was 32 (23-45) years and 187 (43%) were male', 'participants given BSS for acute diarrhea', 'adults with diarrhea', 'eligible patients, 39 declined to participate, 440 enrolled, and 1 enrolled participant was lost to follow-up, for a total of 439 patients included in the analysis', 'Two hundred twenty patients', 'Participants were patients aged 15 to 65 years with acute, nonbloody diarrhea from 22 outpatient clinics in Karachi, Pakistan', 'adult outpatients with diarrhea given bismuth subsalicylate (BSS) or placebo']","['BSS or placebo', 'placebo', 'Bismuth Subsalicylate vs Placebo']","['Measures\n\n\nUse of systemic antibiotics', 'diarrhea resolution', 'Rates of care seeking and hospitalization', 'systemic antibiotics', 'measures of duration and severity of illness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0053792', 'cui_str': 'bismuth subsalicylate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0053792', 'cui_str': 'bismuth subsalicylate'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]",440.0,0.396332,"Use of any antibiotic was significantly lower in the BSS group (20 of 220 vs 34 of 219 patients; odds ratio [OR], 0.54; 95% CI, 0.30-0.98), as was use of fluoroquinolones (8 of 220 vs 20 of 219 patients; OR, 0.38; 95% CI, 0.16-0.88).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Mubina', 'Initials': 'M', 'LastName': 'Agboatwalla', 'Affiliation': 'Health-Oriented Preventive Education, Karachi, Pakistan.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pitz', 'Affiliation': 'Procter & Gamble Health Care, Cincinnati, Ohio.'}, {'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Salahuddin', 'Affiliation': 'Health-Oriented Preventive Education, Karachi, Pakistan.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Brum', 'Affiliation': 'Procter & Gamble Health Care, Cincinnati, Ohio.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Plikaytis', 'Affiliation': 'BioStat Consulting, LLC, Jasper, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9441']
2443,31490251,Quality of Recovery After Breast Surgery: A Multicenter Randomized Clinical Trial Comparing Pectoral Nerves Interfascial Plane (Pectoral Nerves II) Block With Surgical Infiltration.,"BACKGROUND
Pectoral nerves (PECS II) block is a popular regional analgesia technique for breast surgery. PECS II block or local infiltration by surgeon may improve outcomes including quality of recovery (QoR).
METHODS
In this multicenter randomized clinical trial, 104 female patients undergoing breast surgery received: (1) PECS II block with local anesthetic and surgical infiltration with 0.9% saline (PECS group) or (2) PECS II block with 0.9% saline and surgical infiltration with local anesthetic (infiltration group). Patients, anesthetists, surgeons, nursing staff, and research assistants were blinded to group allocation. Patients received standardized general anesthesia and multimodal analgesia. The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional) QoR-15 questionnaire measured 24 hours postoperatively. Secondary outcomes were pain, and its functional interference measured 24 hours and 3 months postoperatively using the Brief Pain Inventory (BPI) short form (0, optimal; 120, worst possible). Randomly assigned groups were compared on outcomes using the Wilcoxon rank-sum test, and the results were reported as median difference with 95% confidence interval.
RESULTS
One hundred eight patients were recruited from August 17, 2016 to June 8, 2018, and 4 patients were withdrawn. Twelve patients from 104 had mastectomy, with the remainder having less invasive surgery. Baseline QoR-15 global scores reported as median [quartiles] were 135 [129, 143] in the PECS group and 139 [127, 143] in the infiltration group. The 24-hour QoR-15 global score reported as median [quartiles] was 131 [116, 140] in the PECS group and 123 [117, 143] in the infiltration group (P = .60), with median difference (95% confidence interval) of -2 (-9 to 5). The median difference reported as infiltration minus PECS for QoR-15 domains was pain 0 (-2 to 1), physical comfort -1 (-3 to 2), physical independence 0 (-2 to 1), psychological support 0 (0-0), and emotions 0 (-1 to 2) (P > .28). The BPI pain subscale at 24 hours (0-40, lower score indicates less pain), reported as median [quartiles], was 7 [2, 13] in the PECS group and 10 [5, 17] in the infiltration group (P = .15). The BPI global score at 24 hours, reported as median [quartiles], was 20 [7, 36] in the PECS group and 23 [10, 43] in the infiltration group (P = .34) and at 3 months was 0 [0, 14] and 0 [0, 11] (P = .85).
CONCLUSIONS
After mostly minor surgery for breast cancer, PECS II block was not superior to local infiltration by the surgeon.",2020,"The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional)","['After Breast Surgery', '104 female patients undergoing breast surgery received: (1', 'One hundred eight patients were recruited from August 17, 2016 to June 8, 2018, and 4 patients were withdrawn', 'Twelve patients from 104 had mastectomy, with the remainder having less invasive surgery']","['Pectoral nerves (PECS II) block', 'PECS II block with local anesthetic and surgical infiltration with 0.9% saline (PECS group) or (2) PECS II block with 0.9% saline and surgical infiltration with local anesthetic (infiltration group', 'standardized general anesthesia and multimodal analgesia', 'PECS', 'Pectoral Nerves Interfascial Plane (Pectoral Nerves II']","['QoR-15 questionnaire', 'global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional', 'BPI pain subscale', 'pain', 'quality of recovery (QoR', 'physical comfort -1 (-3 to 2), physical independence 0', 'pain, and its functional interference measured 24 hours and 3 months postoperatively using the Brief Pain Inventory (BPI) short form (0, optimal; 120, worst possible', 'Baseline QoR-15 global scores', 'Quality of Recovery', '24-hour QoR-15 global score', 'BPI global score']","[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4273496', 'cui_str': 'Modified PECS block'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}]",104.0,0.164772,"The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional)","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Barrington', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Gloria J', 'Initials': 'GJ', 'LastName': 'Seah', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gotmaker', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lim', 'Affiliation': ""Pharmacy, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Byrne', 'Affiliation': 'Department of Anaesthesia, Waikato Hospital, Hamilton, New Zealand.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004371']
2444,31808921,Effect of True and Sham Acupuncture on Radiation-Induced Xerostomia Among Patients With Head and Neck Cancer: A Randomized Clinical Trial.,"Importance
Radiation-induced xerostomia (RIX) is a common, often debilitating, adverse effect of radiation therapy among patients with head and neck cancer. Quality of life can be severely affected, and current treatments have limited benefit.
Objective
To determine if acupuncture can prevent RIX in patients with head and neck cancer undergoing radiation therapy.
Design, Setting, and Participants
This 2-center, phase 3, randomized clinical trial compared a standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA) among patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centers in the United States and China. Patients were enrolled between December 16, 2011, and July 7, 2015. Final follow-up was August 15, 2016. Analyses were conducted February 1 through 28, 2019.
Intervention
Either TA or SA using a validated acupuncture placebo device was performed 3 times per week during a 6- to 7-week course of radiation therapy.
Main Outcomes and Measures
The primary end point was RIX, as determined by the Xerostomia Questionnaire in which a higher score indicates worse RIX, for combined institutions 1 year after radiation therapy ended. Secondary outcomes included incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes.
Results
Of 399 patients randomized, 339 were included in the final analysis (mean [SD] age, 51.3 [11.7] years; age range, 21-79 years; 258 [77.6%] men), including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group. For the primary aim, the adjusted least square mean (SD) xerostomia score in the TA group (26.6 [17.7]) was significantly lower than in the SCC group (34.8 [18.7]) (P = .001; effect size = -0.44) and marginally lower but not statistically significant different from the SA group (31.3 [18.6]) (P = .06; effect size = -0.26). Incidence of clinically significant xerostomia 1 year after radiation therapy ended followed a similar pattern, with 38 patients in the TA group (34.6%), 54 patients in the SA group (47.8%), and 60 patients in the SCC group (55.1%) experiencing clinically significant xerostomia (P = .009). Post hoc comparisons revealed a significant difference between the TA and SCC groups at both institutions, but TA was significantly different from SA only at Fudan University Cancer Center, Shanghai, China (estimated difference [SE]: TA vs SCC, -9.9 [2.5]; P < .001; SA vs SCC, -1.7 [2.5]; P = .50; TA vs SA, -8.2 [2.5]; P = .001), and SA was significantly different from SCC only at the University of Texas MD Anderson Cancer Center, Houston, Texas (estimated difference [SE]: TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).
Conclusions and Relevance
This randomized clinical trial found that TA resulted in significantly fewer and less severe RIX symptoms 1 year after treatment vs SCC. However, further studies are needed to confirm clinical relevance and generalizability of this finding and to evaluate inconsistencies in response to sham acupuncture between patients in the United States and China.
Trial Registration
ClinicalTrials.gov identifier: NCT01266044.",2019,"TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).
","['399 patients randomized, 339 were included in the final analysis (mean [SD] age, 51.3 [11.7] years; age range, 21-79 years; 258 [77.6%] men), including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group', 'patients with head and neck cancer undergoing radiation therapy', 'Patients were enrolled between December 16, 2011, and July 7, 2015', 'patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centers in the United States and China', 'Patients With Head and Neck Cancer', 'patients with head and neck cancer']","['TA or SA', 'TA', 'True and Sham Acupuncture', 'acupuncture placebo device', 'Importance\n\n\nRadiation-induced xerostomia (RIX', 'standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA', 'acupuncture']","['RIX, as determined by the Xerostomia Questionnaire', 'SA', 'adjusted least square mean (SD) xerostomia score', 'incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes', 'severe RIX symptoms', 'xerostomia', 'Quality of life', 'Radiation-Induced Xerostomia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1275047', 'cui_str': 'Radiation-induced xerostomia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0729650', 'cui_str': 'Constituents (substance)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1275047', 'cui_str': 'Radiation-induced xerostomia'}]",339.0,0.161611,"TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).
","[{'ForeName': 'M Kay', 'Initials': 'MK', 'LastName': 'Garcia', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chambers', 'Affiliation': 'Department of Dental Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Peiying', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Chaosu', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Caijun', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Bei', 'Affiliation': 'Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Prinsloo', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chiang', 'Affiliation': 'Department of Anesthesiology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lopez', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.16910']
2445,31644515,Intranasal dexmedetomidine premedication in children with recent upper respiratory tract infection undergoing interventional cardiac catheterisation: A randomised controlled trial.,"BACKGROUND
Recent upper respiratory tract infection (URI) is a risk factor for the occurrence of peri-operative respiratory adverse events (PRAE). This risk may be higher in children with congenital heart disease (CHD), particularly in those undergoing interventional cardiac catheterisation. It is therefore essential to adapt the anaesthetic strategy in these children to prevent from the occurrence of PRAE.
OBJECTIVE
To determine whether intranasal dexmedetomidine (DEX) premedication can reduce the incidence of PRAE in children with recent URI undergoing interventional cardiac catheterisation.
DESIGN
Randomised controlled trial.
SETTING
Single-centre study based at a tertiary care centre in Shanghai, China.
PATIENTS
A total of 134 children with CHD aged 0 to 16 years with recent URI undergoing interventional cardiac catheterisation.
INTERVENTIONS
Children were randomised to receive either intranasal DEX 1.5 μg kg (DEX group) or intranasal saline (Placebo group) 30 to 45 min before anaesthesia induction.
MAIN OUTCOME MEASURES
The incidence of PRAE.
RESULTS
Intranasal DEX significantly reduced the incidence of PRAE (P = 0.001), particularly oxygen desaturation (P = 0.012). Most PRAE were observed during the emergence phase. The incidence of PRAE was comparable among the three types of left-right shunt CHD children in both groups. In children aged less than 3 years, the incidence of PRAE was significantly lower in the DEX group (P = 0.003). In contrast, the incidence of PRAE was comparable between the two groups in children aged at least 3 years. No differences in the incidence of emergence agitation, fever and vomiting between the two groups were noted.
CONCLUSION
Administration of intranasal DEX 1.5 μg kg 30 to 45 min before induction led to a reduction in the incidence of PRAE in children aged less than 3 years with recent URI undergoing interventional cardiac catheterisation.
TRIAL REGISTRATION
chictr.org.cn identifier: ChiCTR-RRC-17012519.",2020,"Intranasal DEX significantly reduced the incidence of PRAE (P = 0.001), particularly oxygen desaturation (P = 0.012).","['134 children with CHD aged 0 to 16 years with recent URI undergoing interventional cardiac catheterisation', 'children with recent upper respiratory tract infection undergoing interventional cardiac catheterisation', 'children with congenital heart disease (CHD', 'Single-centre study based at a tertiary care centre in Shanghai, China', 'children aged less than 3 years with recent URI undergoing interventional cardiac catheterisation', 'children with recent URI undergoing interventional cardiac catheterisation']","['Intranasal DEX', 'dexmedetomidine (DEX) premedication', 'intranasal DEX 1.5\u200aμg\u200akg (DEX group) or intranasal saline (Placebo', 'intranasal DEX', 'Intranasal dexmedetomidine premedication', 'DEX']","['incidence of PRAE', 'incidence of emergence agitation, fever and vomiting', 'particularly oxygen desaturation']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",134.0,0.209088,"Intranasal DEX significantly reduced the incidence of PRAE (P = 0.001), particularly oxygen desaturation (P = 0.012).","[{'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""From the Department of Anaesthesiology (SZ, RZ, MC, KZ, MZ, JZ) and Paediatric Clinical Pharmacology Laboratory, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (MZ, JZ).""}, {'ForeName': 'Ruidong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Meihua', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Mazhong', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jijian', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001097']
2446,31894015,The Community Resiliency Model® to promote nurse well-being.,"BACKGROUND
Rising rates of secondary traumatic stress and burnout among nurses signal a crisis in healthcare. There is a lack of evidence regarding effective interventions to improve nurse well-being and resiliency.
PURPOSE
This study used a randomized controlled trial parallel design to test the effectiveness of a 3-hour Community Resiliency Model® (CRM) training, a novel set of sensory awareness techniques to improve emotional balance.
METHODS
Registered nurses in two urban tertiary-care hospitals were invited to participate, which entailed attending a single 3-hour ""Nurse Wellness and Well-being"" class; 196 nurses consented and were randomized into the CRM intervention or nutrition education control group to determine if the CRM group would demonstrate improvement in well-being and resiliency, secondary traumatic stress, burnout, and physical symptoms.
FINDINGS
Pre/post data were analyzed for 40 CRM and 37 nutrition group members. Moderate-to-large effect sizes were demonstrated in the CRM group for improved well-being, resiliency, secondary traumatic stress, and physical symptoms. Participants reported using CRM techniques for self-stabilization during stressful work events.
DISCUSSION
CRM shows promise as a brief resiliency training for hospital-based nurses.",2020,"Moderate-to-large effect sizes were demonstrated in the CRM group for improved well-being, resiliency, secondary traumatic stress, and physical symptoms.","['nurses signal a crisis in healthcare', 'Registered nurses in two urban tertiary-care hospitals were invited to participate, which entailed attending a single 3-hour ""Nurse Wellness and Well-being"" class; 196 nurses consented']","['CRM intervention or nutrition education control', 'CRM', '3-hour Community Resiliency Model® (CRM) training']","['well-being, resiliency, secondary traumatic stress, and physical symptoms']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse (occupation)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",196.0,0.0288997,"Moderate-to-large effect sizes were demonstrated in the CRM group for improved well-being, resiliency, secondary traumatic stress, and physical symptoms.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Grabbe', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA. Electronic address: lgrabbe@emory.edu.'}, {'ForeName': 'Melinda K', 'Initials': 'MK', 'LastName': 'Higgins', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Baird', 'Affiliation': 'Emory Healthcare, Atlanta, GA.'}, {'ForeName': 'Patricia Ann', 'Initials': 'PA', 'LastName': 'Craven', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'San Fratello', 'Affiliation': 'Emory Healthcare, Atlanta, GA.'}]",Nursing outlook,['10.1016/j.outlook.2019.11.002']
2447,30755698,The effects of a teaching intervention on weight bias among kinesiology undergraduate students.,"OBJECTIVES
Weight bias is present among kinesiology professionals and this may cause a significant negative impact on their clients with obesity. Thus, our objective was to test if learning about uncontrollable cause of obesity and about weight bias would reduce explicit and implicit weight bias among kinesiology undergraduate students compared to the traditional curriculum which is more focused on controllable causes of weight gain.
METHODS
We recruited undergraduates from two classes of the same kinesiology major course taught by the same instructor. In-class teaching activities consisted of 80 min lecture on day 1, video watching session and a group activity on day 3 for both groups. Intervention group (n = 33) learned about uncontrollable causes of obesity and about weight bias and had activities to evoke empathy. Control group (n = 34) learned the traditional curriculum where they learned the role of exercise and diet in weight management. We measured explicit and implicit weight bias using Anti-Fat Attitude Test (AFAT) and Implicit Association Test (IAT), respectively pre-intervention, immediate post intervention and 1 month later.
RESULTS
In mixed model analysis, AFAT Blame scores had significant group by time interaction (p < 0.001). Blame scores significantly reduced with mean differences (standard error (SE)) of -0.35 (0.08) post intervention (p < 0.001) and persisted to be reduced with mean differences (SE) of -0.39 (0.08) even after 4-week follow-up (p < 0.001) only in the intervention group. Odds of having less implicit weight bias was significantly lower at 4-week follow-up than pre-intervention (odds ratio = 0.4; 95% CI: 0.22-0.73) in the control group but no changes were seen in the intervention group.
CONCLUSIONS
""Blame"" component of explicit weight bias significantly decreased when students learned about controllable causes of obesity and weight bias, but implicit bias did not reduce. However, implicit weight bias appears to increase when education on obesity is limited to diet and exercise interventions as taught in the traditional curriculum.",2019,"In mixed model analysis, AFAT Blame scores had significant group by time interaction (p < 0.001).","['kinesiology undergraduate students', 'We recruited undergraduates from two classes of the same kinesiology major course taught by the same instructor']","['teaching intervention', 'Control group (n\u2009=\u200934) learned the traditional curriculum where they learned the role of exercise and diet in weight management']","['implicit weight bias', 'explicit and implicit weight bias using Anti-Fat Attitude Test (AFAT) and Implicit Association Test (IAT', 'weight bias']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0556993', 'cui_str': 'Instructor (occupation)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",,0.0242101,"In mixed model analysis, AFAT Blame scores had significant group by time interaction (p < 0.001).","[{'ForeName': 'Nadeeja N', 'Initials': 'NN', 'LastName': 'Wijayatunga', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Youngdeok', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Winfield S', 'Initials': 'WS', 'LastName': 'Butsch', 'Affiliation': 'Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Dhurandhar', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA. Emily.dhurandhar@ttu.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0325-0']
2448,31482360,A low-residue diet before colonoscopy tends to improve tolerability by patients with no differences in preparation quality: a randomized trial.,"BACKGROUND
The pre-colonoscopy diet traditionally involves 24 h of a clear liquid diet (CLD) in combination with a lavage solution; however, this preparation is poorly tolerated.
AIM
To compare the impact on the quality of bowel cleansing and tolerability of a CLD versus a low-residue diet (LRD).
METHODS
We performed a randomized trial. Subjects were randomized to CLD or LRD the day before of elective colonoscopy. All subjects received a 4-L preparation of single-dose PEG beginning 16 h prior to colonoscopy. The Boston bowel preparation scale was used to evaluate bowel cleansing; an adequate-quality preparation was defined as a score ≥ 2 per segment.
RESULTS
A total of 205 subjects were included with a mean age (SD) of 55.6 (12.6) years; 133 (64.9%) of them were female. A total of 105 subjects were randomized to receive CLD and 100 to LRD. No significant differences in bowel preparation quality were observed between groups according to the section of colon: right colon (70% vs. 73%, p = 0.08), transverse colon (82% vs. 79%, p = 0.062), or left colon (80% vs. 78.7%, p = 0.28). There was a tendency toward less-frequent nausea (p = 0.08) and vomiting (p = 0.07) in patients with LRD. No differences between groups regarding ADR (12% vs. 10%) were noted.
CONCLUSIONS
An LRD before colonoscopy resulted in a tendency toward improved tolerability by patients, with no differences in the quality of bowel preparation.",2020,"No significant differences in bowel preparation quality were observed between groups according to the section of colon: right colon (70% vs. 73%, p = 0.08), transverse colon (82% vs. 79%, p = 0.062), or left colon (80% vs. 78.7%, p = 0.28).","['105 subjects', 'A total of 205 subjects were included with a mean age (SD) of 55.6 (12.6) years; 133 (64.9%) of them were female']","['CLD', '4-L preparation of single-dose PEG beginning 16\xa0h prior to colonoscopy', 'CLD versus a low-residue diet (LRD', 'CLD or LRD']","['vomiting', 'tolerability', 'quality of bowel cleansing and tolerability', 'frequent nausea', 'quality of bowel preparation', 'bowel preparation quality', 'transverse colon', 'section of colon: right colon']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0055926', 'cui_str': 'endogenous clonidine-like substance'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet (finding)'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0227386', 'cui_str': 'Transverse colon structure'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}]",205.0,0.109691,"No significant differences in bowel preparation quality were observed between groups according to the section of colon: right colon (70% vs. 73%, p = 0.08), transverse colon (82% vs. 79%, p = 0.062), or left colon (80% vs. 78.7%, p = 0.28).","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Gómez-Reyes', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Tepox-Padrón', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Cano-Manrique', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico.'}, {'ForeName': 'Natalia J', 'Initials': 'NJ', 'LastName': 'Vilchis-Valadez', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico.'}, {'ForeName': 'Stefany', 'Initials': 'S', 'LastName': 'Mora-Bulnes', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Medrano-Duarte', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico.'}, {'ForeName': 'Luis Gerardo', 'Initials': 'LG', 'LastName': 'Chaires-Garza', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Grajales-Figueroa', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ruiz-Romero', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico.'}, {'ForeName': 'Félix I', 'Initials': 'FI', 'LastName': 'Téllez-Ávila', 'Affiliation': 'Gastrointestinal Endoscopy Department of the National Institute of Medical Sciences and Nutrition Salvador Zubiran, Vasco de Quiróga #15, Sección XVI, Tlalpan, 14000, Mexico City, Mexico. felixtelleza@gmail.com.'}]",Surgical endoscopy,['10.1007/s00464-019-07100-6']
2449,30918843,Substitution of red meat with soybean but not non- soy legumes improves inflammation in patients with type 2 diabetes; a randomized clinical trial.,"Background and aims
Several studies have documented that consumption of legumes including soybean is inversely associated with systemic inflammation and oxidative stress. This study was done to assess the effects of soy beans or non-soy legumes consumption on C-reactive protein (CRP) and malondialdehyde (MDA) among Patients with Type 2 Diabetes (T2D).
Methods
75 persons with T2D participated in this randomized controlled clinical trial. Participants were randomized to one of the following 3 groups for 8 weeks: soy bean group (taking a cup of cooked soy beans three days a week), legumes group (taking a cup of cooked non-soy legumes three days a week) and control group (taking two servings of red meat three days a week). Anthropometric indices, dietary intakes, and serum MDA and CRP were measured at baseline and after intervention.
Results
A Significant decrease was observed in serum CRP of soy bean group ( P = 0.01) which was significantly more than the controls ( p = 0.001), while no significant changes of CRP was observed in legume group. Serum MDA changed significantly in none of the 3 groups.
Conclusions
In conclusion, we found that substitution of red meat with soybean but not non- soy legumes may reduce inflammatory factors with no effects on oxidative stress in diabetic patients.",2018,"A Significant decrease was observed in serum CRP of soy bean group ( P = 0.01) which was significantly more than the controls ( p = 0.001), while no significant changes of CRP was observed in legume group.","['75 persons with T2D participated', 'Patients with Type 2 Diabetes (T2D', 'patients with type 2 diabetes', 'diabetic patients']","['red meat with soybean but not non- soy legumes', 'soy bean group (taking a cup of cooked soy beans three days a week), legumes group (taking a cup of cooked non-soy legumes three days a week) and control group (taking two servings of red meat three days a week', 'soy beans or non-soy legumes consumption']","['oxidative stress', 'serum CRP', 'Anthropometric indices, dietary intakes, and serum MDA and CRP', 'CRP', 'Serum MDA', 'C-reactive protein (CRP) and malondialdehyde (MDA']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0452848', 'cui_str': 'Red Meat'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}, {'cui': 'C0453184', 'cui_str': 'Legumes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}]",75.0,0.0708769,"A Significant decrease was observed in serum CRP of soy bean group ( P = 0.01) which was significantly more than the controls ( p = 0.001), while no significant changes of CRP was observed in legume group.","[{'ForeName': 'Zeynab', 'Initials': 'Z', 'LastName': 'Hematdar', 'Affiliation': '1Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Ghasemifard', 'Affiliation': '1Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Phishdad', 'Affiliation': '2Department of Internal Medicine, Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Faghih', 'Affiliation': '1Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-018-0346-6']
2450,29505145,"High-Dose Vitamin D 3 Administration Is Associated With Increases in Hemoglobin Concentrations in Mechanically Ventilated Critically Ill Adults: A Pilot Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND
Anemia and vitamin D deficiency are highly prevalent in critical illness, and vitamin D status has been associated with hemoglobin concentrations in epidemiologic studies. We examined the effect of high-dose vitamin D therapy on hemoglobin and hepcidin concentrations in critically ill adults.
MATERIALS AND METHODS
Mechanically ventilated critically ill adults (N = 30) enrolled in a pilot double-blind, randomized, placebo-controlled trial of high-dose vitamin D 3 (D 3 ) were included in this analysis. Participants were randomized to receive placebo, 50,000 IU D 3 , or 100,000 IU D 3 daily for 5 days (totaling 250,000 IU D 3 and 500,000 IU D 3 , respectively). Blood was drawn weekly throughout hospitalization for up to 4 weeks. Linear mixed-effects models were used to assess change in hemoglobin and hepcidin concentrations by treatment group over time.
RESULTS
At enrollment, >75% of participants in all groups had plasma 25-hydroxyvitamin D (25(OH)D) concentrations <30 ng/mL, and >85% of participants across groups were anemic. In the 500,000-IU D 3 group, hemoglobin concentrations increased significantly over time (P group × time = .01) compared with placebo but did not change in the 250,000-IU D 3 group (P group × time = 0.59). Hepcidin concentrations decreased acutely in the 500,000-IU D 3 group relative to placebo after 1 week (P = .007). Hepcidin did not change significantly in the 250,000-IU D 3 group.
CONCLUSION
In these critically ill adults, treatment with 500,000 IU D 3 was associated with increased hemoglobin concentrations over time and acutely reduced serum hepcidin concentrations. These findings suggest that high-dose vitamin D may improve iron metabolism in critical illness and should be confirmed in larger studies.",2018,"Hepcidin concentrations decreased acutely in the 500,000-IU D 3 group relative to placebo after 1 week (P = .007).","['Mechanically ventilated critically ill adults (N = 30', 'Mechanically Ventilated Critically Ill Adults', 'critically ill adults']","['vitamin D', 'Placebo', 'vitamin D therapy', 'placebo']","['plasma 25-hydroxyvitamin D (25(OH)D) concentrations', 'Hepcidin', 'Hemoglobin Concentrations', 'hemoglobin and hepcidin concentrations', 'serum hepcidin concentrations', 'hemoglobin concentrations', 'Hepcidin concentrations']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",30.0,0.751894,"Hepcidin concentrations decreased acutely in the 500,000-IU D 3 group relative to placebo after 1 week (P = .007).","[{'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Smith', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Jenny E', 'Initials': 'JE', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Alvarez', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Sloan', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Konrad', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Susu M', 'Initials': 'SM', 'LastName': 'Zughaier', 'Affiliation': 'Department of Microbiology and Immunology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Greg S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Ziegler', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Vin', 'Initials': 'V', 'LastName': 'Tangpricha', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, Georgia, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1177/0148607116678197']
2451,31858696,"Study of pharmacist intervention in polypharmacy among older patients: Non-randomized, controlled trial.","AIM
We investigated the outcomes of interdisciplinary drug therapy interventions by pharmacists among older residents of special elderly nursing homes.
METHODS
The study was designed as a non-randomized, parallel-group, controlled study. Four nursing homes were allocated in a 1:1 ratio to an intervention group (IG) or control group (CG). The participants of the study were residents taking five or more medications. The nursing homes in the IG were each visited by one pharmacist, who was charged with looking for potential problems in drug therapy. Activities in the CG were carried out as usual. The intervention period was 6 months. The primary end-points were the incidences of potentially inappropriate medication (PIM) and falls. The mean difference and proportion of participants were compared between groups.
RESULTS
Data from 28 participants in the IG and 27 participants in the CG were analyzed. The number of PIM decreased from 2.64 at baseline to 2.39 after 6 months in the IG (P = 0.032). The proportion of participants in whom the use of PIM was reduced without problems was 17.9% in the IG and 3.7% in the CG (P = 0.094). The mean number of falls was 0.04 in the IG and 0.41 in the CG (P = 0.033). Falls occurred in 3.6% of participants in the IG and 22.2% of participants in the CG (P = 0.043).
CONCLUSIONS
The results suggested a trend toward fewer PIM and falls in the IG. Geriatr Gerontol Int 2019; ••: ••-••.",2020,The mean number of falls was 0.04 in the IG and 0.41 in the CG (P = 0.033).,"['Four nursing homes', 'participants of the study were residents taking five or more medications', 'older residents of special elderly nursing homes', '28 participants in the IG and 27 participants in the CG were analyzed', 'polypharmacy among older patients']","['pharmacist intervention', 'interdisciplinary drug therapy interventions', 'intervention group (IG) or control group (CG']","['number of PIM', 'incidences of potentially inappropriate medication (PIM) and falls', 'Falls', 'PIM and falls', 'mean number of falls']","[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0644188', 'cui_str': 'CG-AM'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0376271,The mean number of falls was 0.04 in the IG and 0.41 in the CG (P = 0.033).,"[{'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Hashimoto', 'Affiliation': 'Saera Pharmacy, Osaka, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Saera Pharmacy, Osaka, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Shimoji', 'Affiliation': 'Saera Pharmacy, Osaka, Japan.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Utsumi', 'Affiliation': 'Well-seikokai, Osaka, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Hosokawa', 'Affiliation': 'Well-seikokai, Osaka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Tochino', 'Affiliation': 'Department of Social and Administrative Pharmacy, Osaka University of Pharmaceutical Sciences, Osaka, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Sanehisa', 'Affiliation': 'Department of Social and Administrative Pharmacy, Osaka University of Pharmaceutical Sciences, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Akishita', 'Affiliation': 'Department of Geriatric Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Mitsuko', 'Initials': 'M', 'LastName': 'Onda', 'Affiliation': 'Department of Social and Administrative Pharmacy, Osaka University of Pharmaceutical Sciences, Osaka, Japan.'}]",Geriatrics & gerontology international,['10.1111/ggi.13850']
2452,31485809,"Comparison Between Preoperative and Intraoperative Administration of Nefopam for Acute and Chronic Postoperative Pain in Colon Cancer Patients: A Prospective, Randomized, Double-Blind Study.","BACKGROUND
The present study was designed as a prospective, randomized, double-blind clinical trial to evaluate the effects of preoperatively administered nefopam on postoperative acute hyperalgesia and the long-term painful sequelae compared to intraoperative administration.
METHODS
One hundred and fifty patients undergoing elective laparoscopic colectomy were enrolled. Group 1 (post-incisional nefopam) patients received saline at 30 min before skin incision followed by intraoperative administration of 20 mg nefopam at 1 h after incision. Group 2 (pre-incisional nefopam) patients were administered 20 mg nefopam before skin incision and received saline after skin incision. At postoperative 2, 6, 24, 48, and 72 h, fentanyl consumption and pain intensities at rest and during deep breathing were evaluated by visual analog scale (VAS). The incidence of the long-term painful sequelae after surgery was evaluated more than one year after surgery.
RESULTS
Cumulative fentanyl consumption during postoperative 72 h was similar between Group 1 and Group 2 (1534 ± 698 μg, 95% CI 1367-1702 μg vs. 1442 ± 721 μg, 95% CI 1266-1618 μg, P = 0.197). VAS pain scores at rest were comparable between the two groups, but VAS scores during deep breathing were significantly lower in Group 2 than in Group 1. Six and five patients complained of mild pain (pain rating 1) at the surgical site in Group 1 and 2, respectively.
CONCLUSIONS
Preoperatively administered nefopam reduced exertional pain compared to intraoperative administration although postoperative analgesic consumption was similar between two groups. It may be helpful to conduct early ambulation and deep breathing during the acute postoperative period in patients undergoing intestinal surgery. Trial registration No: KCT0001656.",2019,Preoperatively administered nefopam reduced exertional pain compared to intraoperative administration although postoperative analgesic consumption was similar between two groups.,"['One hundred and fifty patients undergoing elective laparoscopic colectomy were enrolled', 'patients undergoing intestinal surgery', 'Colon Cancer Patients']","['saline at 30\xa0min before skin incision followed by intraoperative administration of 20\xa0mg nefopam at 1\xa0h after incision', '20\xa0mg nefopam before skin incision and received saline after skin incision', 'Nefopam']","['exertional pain', 'postoperative analgesic consumption', 'VAS pain scores', 'incidence of the long-term painful sequelae', 'Cumulative fentanyl consumption', 'visual analog scale (VAS', 'VAS scores during deep breathing', 'fentanyl consumption and pain intensities at rest and during deep breathing', 'mild pain', 'postoperative acute hyperalgesia']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0027556', 'cui_str': 'Nefopam'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1328799', 'cui_str': 'Deep breathing (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}]",150.0,0.606468,Preoperatively administered nefopam reduced exertional pain compared to intraoperative administration although postoperative analgesic consumption was similar between two groups.,"[{'ForeName': 'Hyungsun', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Sehrin', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Seonghoon', 'Initials': 'S', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Jeonbuk, Republic of Korea. shko@jbnu.ac.kr.'}]",World journal of surgery,['10.1007/s00268-019-05119-3']
2453,30193275,Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure: A Randomized Clinical Trial.,"Importance
The optimal temporal approach for reducing nicotine to minimally or nonaddictive levels in all cigarettes sold in the United States has not been determined.
Objectives
To determine the effects of immediate vs gradual reduction in nicotine content to very low levels and as compared with usual nicotine level cigarettes on biomarkers of toxicant exposure.
Design, Setting, and Participants
A double-blind, randomized, parallel-design study with 2 weeks of baseline smoking and 20 weeks of intervention was conducted at 10 US sites. A volunteer sample of daily smokers with no intention to quit within 30 days was recruited between July 2014 and September 2016, with the last follow-up completed in March 2017.
Interventions
(1) Immediate reduction to 0.4 mg of nicotine per gram of tobacco cigarettes; (2) gradual reduction from 15.5 mg to 0.4 mg of nicotine per gram of tobacco cigarettes with 5 monthly dose changes; or (3) maintenance on 15.5 mg of nicotine per gram of tobacco cigarettes.
Main Outcomes and Measures
Between-group differences in 3 co-primary biomarkers of smoke toxicant exposure: breath carbon monoxide (CO), urine 3-hydroxypropylmercapturic acid (3-HPMA, metabolite of acrolein), and urine phenanthrene tetraol (PheT, indicator of polycyclic aromatic hydrocarbons) calculated as area under the concentration-time curve over the 20 weeks of intervention.
Results
Among 1250 randomized participants (mean age, 45 years; 549 women [44%]; 958 [77%] completed the trial), significantly lower levels of exposure were observed in the immediate vs gradual reduction group for CO (mean difference, -4.06 parts per million [ppm] [95% CI, -4.89 to -3.23]; P < .0055), 3-HPMA (ratio of geometric means, 0.83 [95% CI, 0.77 to 0.88]; P < .0055), and PheT (ratio of geometric means, 0.88 [95% CI, 0.83 to 0.93]; P < .0055). Significantly lower levels of exposure were observed in the immediate reduction vs control group for CO (mean difference, -3.38 [95% CI, -4.40 to -2.36]; P < .0055), 3-HPMA (ratio of geometric means, 0.81 [95% CI, 0.75 to 0.88]; P < .0055), and PheT (ratio of geometric means, 0.86 [95% CI, 0.81 to 0.92]; P < .0055). No significant differences were observed between the gradual reduction vs control groups for CO (mean difference, 0.68 [95% CI, -0.31 to 1.67]; P = .18), 3-HPMA (ratio of geometric means, 0.98 [95% CI, 0.91 to 1.06]; P = .64), and PheT (ratio of geometric means, 0.98 [95% CI, 0.92 to 1.04]; P = .52).
Conclusions and Relevance
Among smokers, immediate reduction of nicotine in cigarettes led to significantly greater decreases in biomarkers of smoke exposure across time compared with gradual reduction or a control group, with no significant differences between gradual reduction and control.
Trial Registration
clinicaltrials.gov Identifier: NCT02139930.",2018,"Significantly lower levels of exposure were observed in the immediate reduction vs control group for CO (mean difference, -3.38","['1250 randomized participants (mean age, 45 years; 549 women [44%]; 958 [77', 'A volunteer sample of daily smokers with no intention to quit within 30 days was recruited between July 2014 and September 2016, with the last follow-up completed in March 2017']",['nicotine per gram of tobacco cigarettes; (2) gradual reduction from 15.5 mg to 0.4 mg of nicotine per gram of tobacco cigarettes with 5 monthly dose changes; or (3) maintenance on 15.5 mg of nicotine per gram of tobacco cigarettes'],"['3 co-primary biomarkers of smoke toxicant exposure: breath carbon monoxide (CO), urine 3-hydroxypropylmercapturic acid (3-HPMA, metabolite of acrolein), and urine phenanthrene tetraol (PheT, indicator of polycyclic aromatic hydrocarbons) calculated as area under the concentration-time curve', 'levels of exposure', '3-HPMA', 'biomarkers of smoke exposure across time']","[{'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0042037'}, {'cui': 'C0073815', 'cui_str': ""2-acetamido-3-(3'-hydroxypropylthio)propanoic acid""}, {'cui': 'C0063186', 'cui_str': 'hydroxypropyl methacrylate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0001204', 'cui_str': 'Acraldehyde'}, {'cui': 'C3181403', 'cui_str': 'phenanthrene tetraol'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0032458', 'cui_str': 'Polycyclic Hydrocarbons, Aromatic'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1250.0,0.185662,"Significantly lower levels of exposure were observed in the immediate reduction vs control group for CO (mean difference, -3.38","[{'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""al'Absi"", 'Affiliation': 'Behavioral Medicine Laboratories, University of Minnesota Medical School, Duluth.'}, {'ForeName': 'Sharon S', 'Initials': 'SS', 'LastName': 'Allen', 'Affiliation': 'Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Carmella', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Menglan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, Providence, Rhode Island.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Lane', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Chap T', 'Initials': 'CT', 'LastName': 'Le', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Leischow', 'Affiliation': 'Health Sciences Research, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Luo', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Paiano', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, Eugene.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sipe', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lori G', 'Initials': 'LG', 'LastName': 'Strayer', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Mei Kuen', 'Initials': 'MK', 'LastName': 'Tang', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",JAMA,['10.1001/jama.2018.11473']
2454,31483156,Heat therapy reduces sympathetic activity and improves cardiovascular risk profile in women who are obese with polycystic ovary syndrome.,"Polycystic ovary syndrome (PCOS) affects up to 15% of women and is associated with increased risk of obesity and cardiovascular disease. Repeated passive heat exposure [termed ""heat therapy"" (HT)] is a lifestyle intervention with the potential to reduce cardiovascular risk in obesity and PCOS. Women with obesity ( n = 18) with PCOS [age 27 ± 4 yr, body mass index (BMI) 41.3 ± 4.7 kg/m 2 ] were matched for age and BMI, then assigned to HT ( n = 9) or time control (CON; n = 9). HT subjects underwent 30 one-hour hot tub sessions over 8-10 wk, whereas CON subjects did not undergo HT. Muscle sympathetic nerve activity (MSNA), blood pressure, cholesterol, C-reactive protein, and markers of vascular function were assessed at the start (Pre) and end (Post) of 8-10 wk. These measures included carotid and femoral artery wall thickness and flow-mediated dilation (FMD), measured both before and after 20 min of ischemia-20 min of reperfusion (I/R) stress. HT subjects exhibited reduced MSNA burst frequency (Pre: 20 ± 8 bursts/min, Post: 13 ± 5 bursts/min, P = 0.012), systolic (Pre: 124 ± 5 mmHg, Post: 114 ± 6 mmHg; P < 0.001) and diastolic blood pressure (Pre: 77 ± 6 mmHg, Post: 68 ± 3 mmHg; P < 0.001), C-reactive protein (Pre: 19.4 ± 13.7 nmol/L, Post: 15.2 ± 12.3 nmol/L; P = 0.018), total cholesterol (Pre: 5.4 ± 1.1 mmol/L, Post: 5.0 ± 0.8 mmol/L; P = 0.028), carotid wall thickness (Pre: 0.054 ± 0.005 cm, Post: 0.044 ± 0.005 cm; P = 0.010), and femoral wall thickness (Pre: 0.056 ± 0.009 cm, Post: 0.042 ± 0.005 cm; P = 0.003). FMD significantly improved in HT subjects over time following I/R (Pre: 5.6 ± 2.5%, Post: 9.5 ± 1.7%; P < 0.001). No parameters changed over time in CON, and BMI did not change in either group. These findings indicate that HT reduces sympathetic nerve activity, provides protection from I/R stress, and substantially improves cardiovascular risk profiles in women who are obese with PCOS.",2019,"HT subjects exhibited reduced MSNA burst frequency (Pre:20±8, Post:13±5 bursts/min, p=0.012), systolic (Pre:124±5, Post:114±6 mmHg; p<0.001) and diastolic blood pressure (Pre:77±6, Post:68±3 mmHg; p<0.001), C-Reactive protein (Pre:19.4±13.7, Post:15.2±12.3 nmol/L; p=0.018), total cholesterol (Pre:5.4±1.1, Post: 5.0±0.8 mmol/L; p=0.028), carotid wall thickness (Pre:0.054±0.005 Post: 0.044±0.005 cm; p=0.010) and femoral wall thickness (Pre:0.056±0.009, Post:0.042±0.005 cm; p=0.003).","['obese women with PCOS', 'obese women with polycystic ovary syndrome', 'Eighteen obese women with PCOS (Age: 27±4y, body mass index']","[""Repeated passive heat exposure (termed 'heat therapy"", 'Heat therapy']","['sympathetic activity', 'time in CON, and BMI', 'Muscle sympathetic nerve activity (MSNA), blood pressure, cholesterol, C-reactive protein, and markers of vascular function', 'cardiovascular risk profiles', 'femoral wall thickness', 'cardiovascular risk profile', 'diastolic blood pressure', 'FMD', 'carotid and femoral artery wall thickness and flow-mediated dilation (FMD', 'risk of obesity and cardiovascular disease', 'MSNA burst frequency', 'C-Reactive protein', 'total cholesterol', 'carotid wall thickness']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0239930', 'cui_str': 'Exposure to heat (event)'}, {'cui': 'C0150611', 'cui_str': 'Heat therapy (procedure)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0015801', 'cui_str': 'Femoral Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",18.0,0.0370644,"HT subjects exhibited reduced MSNA burst frequency (Pre:20±8, Post:13±5 bursts/min, p=0.012), systolic (Pre:124±5, Post:114±6 mmHg; p<0.001) and diastolic blood pressure (Pre:77±6, Post:68±3 mmHg; p<0.001), C-Reactive protein (Pre:19.4±13.7, Post:15.2±12.3 nmol/L; p=0.018), total cholesterol (Pre:5.4±1.1, Post: 5.0±0.8 mmol/L; p=0.028), carotid wall thickness (Pre:0.054±0.005 Post: 0.044±0.005 cm; p=0.010) and femoral wall thickness (Pre:0.056±0.009, Post:0.042±0.005 cm; p=0.003).","[{'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Francisco', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Samantha D', 'Initials': 'SD', 'LastName': 'Bryan', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Lindan N', 'Initials': 'LN', 'LastName': 'Comrada', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Larson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Vienna E', 'Initials': 'VE', 'LastName': 'Brunt', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Minson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00078.2019']
2455,32494991,Impact of a pharmacist-administered deprescribing intervention on nursing home residents: a randomized controlled trial.,"Background Polypharmacy is prevalent among long-term care residents in Canada, with 48.4% receiving ten or more different medications and 40.7% chronically prescribed potentially inappropriate medications. Objective We implemented a pharmacist-administered deprescribing program in a long-term care facility to determine if the number of medications taken per resident could be reduced.
SETTING
A long-term care facility in Newfoundland and Labrador, Canada from February 2017 to February 2018.
METHOD
Residents were randomized to receive either a deprescribing-focused medication review by a pharmacist or usual care. Main outcome measure Change in the number of medications at 3 and 6 months. Results Forty-five residents enrolled in the study (n = 22 intervention, n = 23 control). Seventy-eight deprescribing recommendations were made, and 85.1% were successfully implemented. The average number of medications taken by residents in the intervention group was 2.68 less than the control group (p < 0.02; 95% CI - 4.284, - 1.071) at 3 months and 2.88 less (p = 0.02, 95% CI - 4.543, - 1.112) at 6 months. In 14.9% of cases, a medication had to be restarted after deprescribing was attempted because symptoms returned.
CONCLUSION
A pharmacist-led deprescribing intervention can reduce the number of unnecessary and potentially harmful medications taken by LTC residents.",2020,"The average number of medications taken by residents in the intervention group was 2.68 less than the control group (p < 0.02; 95% CI - 4.284, - 1.071) at 3 months and 2.88 less (p = 0.02, 95% CI - 4.543, - 1.112) at 6 months.","['Results Forty-five residents enrolled in the study (n\u2009=\u200922 intervention, n\u2009=\u200923 control', 'nursing home residents', 'Residents', 'A long-term care facility in Newfoundland and Labrador, Canada from February 2017 to February 2018']","['deprescribing-focused medication review by a pharmacist or usual care', 'pharmacist-administered deprescribing program', 'pharmacist-administered deprescribing intervention']","['number of medications at 3 and 6\xa0months', 'average number of medications taken']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1956182', 'cui_str': 'Newfoundland and Labrador'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}]",45.0,0.102374,"The average number of medications taken by residents in the intervention group was 2.68 less than the control group (p < 0.02; 95% CI - 4.284, - 1.071) at 3 months and 2.88 less (p = 0.02, 95% CI - 4.543, - 1.112) at 6 months.","[{'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Balsom', 'Affiliation': ""Medication Therapy Services Clinic, School of Pharmacy, Memorial University, St. John's, NF, Canada. catherineb@mun.ca.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pittman', 'Affiliation': ""Medication Therapy Services Clinic, School of Pharmacy, Memorial University, St. John's, NF, Canada.""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'King', 'Affiliation': ""St. Patrick's Mercy Home, St. John's, NF, Canada.""}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': ""Medication Therapy Services Clinic, School of Pharmacy, Memorial University, St. John's, NF, Canada.""}]",International journal of clinical pharmacy,['10.1007/s11096-020-01073-6']
2456,31645430,Maternal Humoral Immune Responses Do Not Predict Postnatal HIV-1 Transmission Risk in Antiretroviral-Treated Mothers from the IMPAACT PROMISE Study.,"To design immune interventions that can synergize with antiretroviral therapy (ART) to reduce the rate of HIV mother-to-child transmission (MTCT), it is essential to characterize maternal immune responses in the setting of ART during pregnancy and breastfeeding and define their effect on MTCT. Prior studies reported an association between breast milk envelope (Env)-specific antibodies and antibody-dependent cell cytotoxicity (ADCC) activity with reduced postnatal transmission. In this study, we investigated whether these immune correlates were similarly associated with protection in a matched case-control study of mother-infant pairs receiving maternal ART or infant nevirapine prophylaxis during breastfeeding in the International Maternal-Pediatric-Adolescent AIDS Clinical Trials Network Promoting Maternal-Infant Survival Everywhere (PROMISE) trial, assessing postnatal transmission risk in 19 transmitting and 57 nontransmitting mothers using conditional logistic regression models adjusted for maternal plasma viral load. The odds ratios of postnatal MTCT for a 1-unit increase in an immune correlate were 3.61 (95% confidence interval [CI], 0.56, 23.14) for breast milk Env-specific secretory IgA (sIgA), 2.32 (95% CI, 0.43, 12.56) for breast milk and 2.16 (95% CI, 0.51, 9.14) for plasma Env-specific IgA, and 4.57 (95% CI, 0.68, 30.48) for breast milk and 0.96 (95% CI, 0.25, 3.67) for plasma ADCC activity, with all CIs spanning 1.0. Interestingly, although mucosal IgA responses are poor in untreated HIV-infected women, there was a strong correlation between the magnitudes of breast milk and plasma Env-specific IgA in this cohort. In this analysis of the small number of postnatal virus transmissions in the landmark PROMISE study, no single antibody response was associated with breast milk transmission risk. IMPORTANCE Each year, >150,000 infants become newly infected with HIV-1 through MTCT despite ART, with up to 42% of infections occurring during breastfeeding. Several factors contribute to continued pediatric infections, including ART nonadherence, the emergence of drug-resistant HIV strains, acute infection during breastfeeding, and poor access to ART in resource-limited areas. A better understanding of the maternal humoral immune responses that provide protection against postnatal transmission in the setting of ART is critical to guide the design of maternal vaccine strategies to further eliminate postnatal HIV transmission. In this study, we found that in women treated with antiretrovirals during pregnancy, there was a positive correlation between plasma viral load and breast milk and plasma IgA responses; however, conclusions regarding odds of MTCT risk were limited by the small sample size. These findings will inform future studies to investigate maternal immune interventions that can synergize with ART to eliminate MTCT during breastfeeding.",2019,"The odds ratios of postnatal MTCT for a 1-unit increase in an immune correlate were 3.61 (95% confidence interval [CI], 0.56, 23.14) for breast milk Env-specific secretory IgA (sIgA), 2.32 (95% CI, 0.43, 12.56) for breast milk and 2.16 (95% CI, 0.51, 9.14) for plasma Env-specific IgA, and 4.57 (95% CI, 0.68, 30.48) for breast milk and 0.96 (95% CI, 0.25, 3.67) for plasma ADCC activity, with all CIs spanning 1.0.","['150,000 infants become newly infected with HIV-1 through MTCT despite ART, with up to 42% of infections occurring during breastfeeding', '19 transmitting and 57 nontransmitting mothers']","['mother-infant pairs receiving maternal ART or infant nevirapine prophylaxis', 'antiretroviral therapy (ART']","['Maternal Humoral Immune Responses', 'plasma ADCC activity', 'cell cytotoxicity (ADCC) activity', 'mucosal IgA responses', 'plasma viral load and breast milk and plasma IgA responses', 'Maternal-Infant Survival', 'Transmission Risk', 'odds ratios of postnatal MTCT']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003272', 'cui_str': 'Antibody-dependent cellular cytotoxicity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}]",150000.0,0.125915,"The odds ratios of postnatal MTCT for a 1-unit increase in an immune correlate were 3.61 (95% confidence interval [CI], 0.56, 23.14) for breast milk Env-specific secretory IgA (sIgA), 2.32 (95% CI, 0.43, 12.56) for breast milk and 2.16 (95% CI, 0.51, 9.14) for plasma Env-specific IgA, and 4.57 (95% CI, 0.68, 30.48) for breast milk and 0.96 (95% CI, 0.25, 3.67) for plasma ADCC activity, with all CIs spanning 1.0.","[{'ForeName': 'Eliza D', 'Initials': 'ED', 'LastName': 'Hompe', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Jacobson', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Eudailey', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Edwards', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Pollara', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Brummel', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Genevieve G', 'Initials': 'GG', 'LastName': 'Fouda', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'University of North Carolina Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Kamanga', 'Affiliation': 'Johns Hopkins University Research Project, Blantyre, Malawi.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Kinikar', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa and School of Clinical Medicine, College of Health Sciences, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Maxensia', 'Initials': 'M', 'LastName': 'Owor', 'Affiliation': 'Johns Hopkins University Research Collaboration, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Sallie R', 'Initials': 'SR', 'LastName': 'Permar', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA sallie.permar@duke.edu.'}]",mSphere,['10.1128/mSphere.00716-19']
2457,32434104,Effect of the mobile phone-related background on inhibitory control of problematic mobile phone use: An event-related potentials study.,"The present study aims to provide electrophysiological evidence for deficient inhibitory control in problematic mobile phone use and to investigate whether reduced inhibition is more pronounced during exposure to a mobile phone related background cue. A screen scale of smartphone addiction was completed by 227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study. Event-related potentials were recorded during a backgrounded Go/NoGo task performed by those two groups, in which either a frequent Go signal (letter ""M"") or a rare NoGo signal (letter ""W"") was superimposed on three different background cues: neutral, mobile phone application-related and mobile phone using-related pictures. Results showed that problematic mobile phone users performed more commission errors than controls following mobile phone application background. Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background. The result might suggest that there is no general impairment of inhibitory control in problematic mobile phone use. The deficient inhibitory control on behavioral and psychophysiological level appeared merely in the mobile phone-related background. Such deficient stimuli-specific inhibitory control appears at the late stage of inhibitory control. Prevention programs should be designed to curtail exposure to the mobile phone-related stimulus and enhance cognitive control of potential problematic mobile phone users.",2020,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","['227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study']",['mobile phone-related background'],"['behavioral and psychophysiological level', 'commission errors', 'NoGo P3 amplitude']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0394788,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","[{'ForeName': 'Lingfeng', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Jingfu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Qingbai', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Zongkui', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China. Electronic address: zhouzk@mail.ccnu.edu.cn.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106363']
2458,31478095,"The effect of high intensity laser therapy in the management of painful calcaneal spur: a double blind, placebo-controlled study.","To evaluate the effect of high-intensity laser therapy (HILT) in patients with calcaneal spur. The patients were randomized to receive either HILT + exercise (n = 21) (five times a week for a period of 3 weeks) or placebo HILT + exercise (n = 21) (five times a week for a period of 3 weeks). Pain severity (with visual analog scale (VAS) and with Roles and Maudsley score (RMS)), functionality (with Foot and Ankle Outcome Score (FAOS)), plantar pressure measurement, and quality of life (with short form-36 (SF-36)) of the patients were evaluated at baseline, at 4 weeks, and 12 weeks. A significant improvement in the VAS (p < 0.001), RMS (p < 0.001), and most of the SF-36 subgroup scores (p < 0.05) and most of the FAOS subgroup scores (p < 0.05) at 4 and 12 weeks after treatment was achieved in both groups. Besides, there was no significant difference in VAS (p > 0.05) and RMS (p > 0.05) between the groups. FAOS symptoms (p = 0.022) and quality of life (p = 0.038) subgroups were higher in the placebo group at 12 weeks. Significant improvements were observed in dynamic pedographic measurements in the HILT group (p < 0.05), and dynamic measurement values were significantly higher in the HILT group compared to placebo group (p < 0.05). Although the evaluation parameters, except dynamic pedographic measurements, have improved in both groups, our study results showed no superiority of HILT over placebo. To conclude, when the main complaint is pain in patients, only exercise therapy can be an economical, practical, and reliable treatment.",2020,"A significant improvement in the VAS (p < 0.001), RMS (p < 0.001), and most of the SF-36 subgroup scores (p < 0.05) and most of the FAOS subgroup scores (p < 0.05) at 4 and 12 weeks after treatment was achieved in both groups.","['painful calcaneal spur', 'patients with calcaneal spur']","['HILT\u2009+\u2009exercise', 'HILT', 'high-intensity laser therapy (HILT', 'placebo', 'high intensity laser therapy', 'placebo HILT\u2009+\u2009exercise']","['FAOS subgroup scores', 'FAOS symptoms', 'SF-36 subgroup scores', 'Pain severity (with visual analog scale (VAS) and with Roles and Maudsley score (RMS)), functionality (with Foot and Ankle Outcome Score (FAOS)), plantar pressure measurement, and quality of life (with short form-36 (SF-36', 'quality of life', 'VAS', 'dynamic measurement values', 'RMS', 'dynamic pedographic measurements']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0158322', 'cui_str': 'Calcaneal Spur'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.201732,"A significant improvement in the VAS (p < 0.001), RMS (p < 0.001), and most of the SF-36 subgroup scores (p < 0.05) and most of the FAOS subgroup scores (p < 0.05) at 4 and 12 weeks after treatment was achieved in both groups.","[{'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Yesil', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey. dradanur@yahoo.com.'}, {'ForeName': 'Umit', 'Initials': 'U', 'LastName': 'Dundar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Toktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}, {'ForeName': 'Nuran', 'Initials': 'N', 'LastName': 'Eyvaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Yeşil', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.'}]",Lasers in medical science,['10.1007/s10103-019-02870-w']
2459,31474491,Mesenchymal stromal cell therapy during ex vivo lung perfusion ameliorates ischemia-reperfusion injury in lung transplantation.,"BACKGROUND
The application of mesenchymal stromal cell (MSC)-based therapy during ex vivo lung perfusion (EVLP) could repair injured donor lungs before transplantation. The aim of this study was to determine the efficacy of MSC therapy performed during EVLP on ischemia-reperfusion injury using a pig lung transplant model.
METHODS
Following 24 hours of cold storage, pig lungs were randomly assigned to 2 groups (n = 6 each), the control group without MSC vs the MSC group, where 5 × 10 6 cells/kg MSCs were delivered through the pulmonary artery during EVLP. After 12 hours of EVLP, followed by a 1-hour second cold preservation period, the left lung was transplanted and reperfused for 4 hours.
RESULTS
EVLP perfusate hepatocyte growth factor (HGF) level at 12 hours was significantly elevated in the MSC group compared with the control and was associated with a significant decrease in cell death markers, cleaved caspase-3 and terminal deoxynucleotidyl transferase dUTP nick end labeling-positive cells, in the MSC group. The MSC group showed significantly lower interleukin (IL)-18 and interferon gamma levels and a significantly higher IL-4 level in lung tissue at 12 hours of EVLP than the control group. After transplantation, the MSC group showed a significant increase in lung tissue HGF level compared with the control group, associated with a significantly reduced lung tissue wet-to-dry weight ratio. Lung tissue tumor necrosis factor-α level and pathological acute lung injury score were significantly lower in the MSC group than the control group.
CONCLUSIONS
The administration of MSCs ameliorated ischemic injury in donor lungs during EVLP and attenuated the subsequent ischemia-reperfusion injury after transplantation.",2019,The MSC group showed significantly lower interleukin (IL)-18 and interferon gamma levels and a significantly higher IL-4 level in lung tissue at 12 hours of EVLP than the control group.,['lung transplantation'],"['MSC therapy', 'EVLP', 'MSC', 'mesenchymal stromal cell (MSC)-based therapy during ex vivo lung perfusion (EVLP', 'control group without MSC vs the MSC group, where 5\u202f×\u202f10 6 cells/kg MSCs were delivered through the pulmonary artery during EVLP', 'Mesenchymal stromal cell therapy', 'MSCs']","['EVLP perfusate hepatocyte growth factor (HGF) level', 'lung tissue wet-to-dry weight ratio', 'interleukin (IL)-18 and interferon gamma levels', 'lung tissue HGF level', 'IL-4 level in lung tissue', 'Lung tissue tumor necrosis factor-α level and pathological acute lung injury score', 'cell death markers, cleaved caspase-3 and terminal deoxynucleotidyl transferase dUTP nick end labeling-positive cells']","[{'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary Artery'}]","[{'cui': 'C0062534', 'cui_str': 'Hepatopoietin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C1168022', 'cui_str': 'Interferon gamma level'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0242488', 'cui_str': 'Acute Lung Injury'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0205242', 'cui_str': 'Cleaved (qualifier value)'}, {'cui': 'C0291573', 'cui_str': 'CASP3'}, {'cui': 'C0687124', 'cui_str': 'Terminal deoxynucleotidyl transferase stain'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",,0.0266859,The MSC group showed significantly lower interleukin (IL)-18 and interferon gamma levels and a significantly higher IL-4 level in lung tissue at 12 hours of EVLP than the control group.,"[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nakajima', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Ohsumi', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Pipkin', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Manyin', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Mordant', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kanou', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tomohito', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Coutinho', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Caldarone', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Juvet', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Martinu', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rohin K', 'Initials': 'RK', 'LastName': 'Iyer', 'Affiliation': 'Tissue Regeneration Therapeutics Inc, Toronto, Ontario, Canada.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Tissue Regeneration Therapeutics Inc, Toronto, Ontario, Canada; Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hwang', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Waddell', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mingyao', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Shaf', 'Initials': 'S', 'LastName': 'Keshavjee', 'Affiliation': 'Latner Thoracic Surgery Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada. Electronic address: shaf.keshavjee@uhn.ca.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2019.07.006']
2460,31391387,Efficacy and Safety of Ivabradine in Japanese Patients With Chronic Heart Failure - J-SHIFT Study.,"BACKGROUND
Increased heart rate (HR) is an independent risk factor for cardiovascular outcomes in chronic heart failure (HF). Ivabradine, anI f inhibitor, improved outcomes in patients with HF and reduced ejection fraction (HFrEF) in the SHIFT study. We evaluated its efficacy and safety in Japanese HFrEF patients in a randomized, double-blind, placebo-controlled phase III study: the J-SHIFT study. The main objective was to confirm a hazard ratio of <1 in the primary composite endpoint of cardiovascular death or hospital admission for worsening HF.Methods and Results:Patients with NYHA functional class II-IV, left ventricular EF ≤35%, and resting HR ≥75 beats/min in sinus rhythm under optimal medical therapy received ivabradine (n=127) or placebo (n=127). Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1 beats/min, P<0.0001). However, symptomatic bradycardia did not occur. A total of 26 (20.5%) patients in the ivabradine group and 37 (29.1%) patients in the placebo group had the primary endpoint event (hazard ratio 0.67, 95% CI 0.40-1.11, P=0.1179) during median follow-up of 589 days. Mild phosphenes were reported in 8 (6.3%) patients in the ivabradine group and 4 (3.1%) patients in the placebo group (P=0.3760).
CONCLUSIONS
The J-SHIFT study supported the efficacy and safety of ivabradine for Japanese HFrEF patients, in accord with the SHIFT study.",2019,"Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1 beats/min, P<0.0001).","['Japanese HFrEF patients', 'patients with HF and reduced ejection fraction (HFrEF) in the SHIFT study', 'chronic heart failure (HF', 'Japanese Patients With Chronic Heart Failure\u3000- J-SHIFT Study']","['Ivabradine', 'ivabradine', 'placebo', 'Ivabradine, anI']","['symptomatic bradycardia', 'Mean reduction in resting HR', 'cardiovascular death or hospital admission', 'efficacy and safety', 'Efficacy and Safety', 'Mild phosphenes']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0326040', 'cui_str': 'Ani'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]",,0.199184,"Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1 beats/min, P<0.0001).","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsui', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Momomura', 'Affiliation': 'Cardiovascular Division, Jichi Medical University, Saitama Medical Center.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine.'}, {'ForeName': 'Yasuki', 'Initials': 'Y', 'LastName': 'Kihara', 'Affiliation': 'Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical & Health Sciences.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'First Department of Internal Medicine, Nara Medical University.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Faculty of Medicine, Tottori University.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Cardiovascular Medicine, Kitasato University.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Inomata', 'Affiliation': 'Cardiovascular Medicine, Kitasato University Kitasato Institute Hospital.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Osaka University.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0227']
2461,12722996,A modular laparoscopic training program for pediatric surgeons.,"OBJECTIVES
A structured endoscopic training program for pediatric surgeons has not yet been established. This study was conducted to develop a modular training program (MTP) for pediatric surgeons and to evaluate its effectiveness for surgeons with and without previous experience in laparoscopic surgery.
METHODS
Nine pediatric surgeons participated in the study. They were divided into 2 groups: group A (n=4), surgeons who had experienced more than 10 cases of laparoscopic surgery prior to MTP; group B (n=5), those who had experienced fewer than 10 cases. They participated in a standardized MTP workshop, which consisted of 2 ""see-through"" and 3 ""laparoscopic"" tasks. Each participant's psychomotor skills were evaluated objectively before and after MTP with a computer-generated virtual simulator and were evaluated for precision, efficiency, and speed.
RESULTS
In participants, speed was significantly enhanced after MTP. In group A, no differences were observed after MTP, whereas significant improvements were noted in efficiency and speed after MTP in group B. Before MTP, efficiency was significantly higher in group A than in group B; however, no difference remained between the 2 groups after MTP.
CONCLUSIONS
MTP is effective for nonlaparoscopic pediatric surgeons to become familiar with basic endoscopic skills.",2003,"In group A, no differences were observed after MTP, whereas significant improvements were noted in efficiency and speed after MTP in group B.","['pediatric surgeons', 'Nine pediatric surgeons participated in the study']","['laparoscopic training program', 'MTP', 'laparoscopic surgery prior to MTP', 'modular training program (MTP', 'endoscopic training program']","['precision, efficiency, and speed', 'efficiency and speed']","[{'cui': 'C0586905', 'cui_str': 'Pediatric surgeon (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0065610', 'cui_str': 'maltose tetrapalmitate'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}]",9.0,0.0241147,"In group A, no differences were observed after MTP, whereas significant improvements were noted in efficiency and speed after MTP in group B.","[{'ForeName': 'Kiyokazu', 'Initials': 'K', 'LastName': 'Nakajima', 'Affiliation': 'Department of Pediatric Surgery, Osaka University Medical School, Suita, Japan. nakajima@pedsurg.med.osaka-u.ac.jp'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Wasa', 'Affiliation': ''}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Takiguchi', 'Affiliation': ''}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Taniguchi', 'Affiliation': ''}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Soh', 'Affiliation': ''}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Ohashi', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okada', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2462,32097286,Physical Activity in Healthcare Workers With Low Back Pain: Effects of the Back-FIT Randomized Trial.,"OBJECTIVE
To evaluate the effects of physical activity program in healthcare workers with low back pain (LBP).
METHODS
A group of healthcare workers participated voluntarily to a meeting about LBP and to be accepted, were randomly allocated to workplace program or to home-based exercises, illustrated in a booklet and in a video available on the company intranet website. Both programs consisted in 7 weeks of moderate intensity exercises adapted to LBP.
RESULTS
Most outcomes improved in both groups, however with larger improvement of the Oswestry Disability Index in the workplace group (P = 0.02).
CONCLUSIONS
Regular physical exercise, at home or at the workplace among healthcare workers with LBP, represents a great opportunity to improve health and reduce disability.",2020,"RESULTS
Most outcomes improved in both groups, however with larger improvement of the Oswestry Disability Index in the workplace group (P = 0.02).
","['Healthcare Workers with Low Back Pain', 'A group of healthcare workers participated voluntarly to a meeting about LBP and to be accepted', 'healthcare workers with low back pain (LBP']","['Physical Activity program', 'workplace program or to home-based exercises, illustrated in a booklet and in a video available on the company intranet website', 'Regular physical exercise']","['Physical Activity', 'Oswestry Disability Index']","[{'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0600191', 'cui_str': 'Intranets'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",,0.0569118,"RESULTS
Most outcomes improved in both groups, however with larger improvement of the Oswestry Disability Index in the workplace group (P = 0.02).
","[{'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Bernardelli', 'Affiliation': ""Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy (Dr Bernardelli, Dr Colonna); Occupational Health Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy (Dr Vigna, Dr Nava, Dr Consonni, Dr Riboldi); National Research Centre for the Working Environment, Copenhagen, Denmark (Dr Andersen).""}, {'ForeName': 'Luisella', 'Initials': 'L', 'LastName': 'Vigna', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Nava', 'Affiliation': ''}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'De Gennaro Colonna', 'Affiliation': ''}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Consonni', 'Affiliation': ''}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Riboldi', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001844']
2463,31364144,"The effects of oral supplements with Sambucus nigra, Zinc, Tyndallized Lactobacillus acidophilus (HA122), Arabinogalactans, vitamin D, vitamin E and vitamin C in otitis media with effusion in children: a randomized controlled trial.","OBJECTIVE
To evaluate the ability of oral supplements with immune-stimulating molecules (Sambucus nigra, Zinc, Tyndallized Lactobacillus acidophilus (HA122), Arabinogalactans, vitamin D, vitamin E and vitamin C) to reduce the inflammation of the upper airway tract and improve the outcome of otitis media with effusion (OME) in children.
PATIENTS AND METHODS
Randomized controlled trial. One-hundred ninety-eight children (CI 95%: 12-96 months) were divided into four groups. Group 1 (48 subjects) received 10 ml of oral supplements (OS) with immune-stimulating molecules for three months (20 days consecutively, then 10 days of suspension - the therapeutic scheme was repeated three times); Group 2 (54 children) underwent treatment with 10 ml of OS for 90 consecutive days; Group 3 (48 subjects) received 15 ml of OS for 45 consecutive days; a control group (48 children) underwent the standard treatment for rhinitis and OME. Outcome measures included otoscopy, tympanometry, fibroendoscopy, and the pure tone audiometry (PTA) at T0 (before treatment), T1 (45 days after treatment), and T2 (90 days after treatment).
RESULTS
All children treated with OS showed a reduction of Upper Airway Infection (UAI) episodes and OME compared to the control group independent of the administration method and posology. The three groups treated with OS showed statistically significant differences between T0 and T2 for otoscopy, tympanometry, fibroendoscopy, and PTA. In Group 2, the otoscopy and the tympanometry scores improved at T1. Group 2 and 3 had better PTA results than Group 1.
CONCLUSIONS
OS with immune-stimulating molecules should be considered as a supporting therapy in children affected by recurrent episodes of UAI associated with OME due to their capacity to improve the immune response and reduce the inflammatory phenomena. OS can improve the fibroendoscopic findings by restoring middle ear ventilation, in addition to their ability to reduce inflammation in the middle ear.",2019,"The three groups treated with OS showed statistically significant differences between T0 and T2 for otoscopy, tympanometry, fibroendoscopy, and PTA.","['otitis media with effusion in children', 'One-hundred ninety-eight children (CI 95%: 12-96 months', 'otitis media with effusion (OME) in children']","['oral supplements with immune-stimulating molecules (Sambucus nigra, Zinc, Tyndallized Lactobacillus acidophilus (HA122), Arabinogalactans, vitamin D, vitamin E and vitamin C', '15 ml of OS', 'oral supplements with Sambucus nigra, Zinc, Tyndallized Lactobacillus acidophilus (HA122), Arabinogalactans, vitamin D, vitamin E and vitamin C', '10 ml of oral supplements (OS) with immune-stimulating molecules', 'standard treatment for rhinitis and OME']","['reduction of Upper Airway Infection (UAI) episodes and OME', 'otoscopy, tympanometry, fibroendoscopy, and the pure tone audiometry (PTA', 'tympanometry scores', 'T0 and T2 for otoscopy, tympanometry, fibroendoscopy, and PTA']","[{'cui': 'C0029883', 'cui_str': 'Otitis Media, Secretory'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0331059', 'cui_str': 'Elder, European'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0847244', 'cui_str': 'Otoscopy'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry'}, {'cui': 'C0004292', 'cui_str': 'Audiometry, Pure-Tone'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",198.0,0.0784292,"The three groups treated with OS showed statistically significant differences between T0 and T2 for otoscopy, tympanometry, fibroendoscopy, and PTA.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Della Volpe', 'Affiliation': ""Otology and Cochlear Implant Unit, Santobono-Pausilipon Children's Hospital, Naples, Italy. massimo.ralli@uniroma1.it.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ricci', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gambacorta', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Lucia', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Minni', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pirozzi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paccone', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pastore', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Stadio', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201907_18460']
2464,31476757,The Effect of Resin Infiltration on the Progression of Proximal Caries Lesions: A Randomized Clinical Trial.,"OBJECTIVE
The aim of this clinical trial was to assess the effect of resin infiltration on the progression of proximal caries lesions.
SUBJECTS AND METHODS
Forty-one patients, aged between 15 and 33 years, with 2 or more non-cavitated proximal caries lesions were included. In 41 of the adolescent and young adults, 45 pairs of proximal lesions with radiological extension into the inner and outer half of the enamel, or into the outer third of the dentin, were randomly allocated to the test groups (resin infiltration application + fluoridated toothpaste and flossing use) or to the control group (fluoridated toothpaste and flossing use). Standardized geometrically aligned digital bitewing radiographs were obtained using individual biting holders. The radiographic progression of the lesions was assessed after 1 year by digital-subtraction radiography. The McNemar test was used for statistical analysis.
RESULTS
In the test group 1/45 of the lesions (2.2%) and in the control group 9/45 of the lesions (20%) showed progression. The caries progression rate of the control group was significantly higher than that of the test group (p < 0.05).
CONCLUSIONS
Resin infiltration of proximal caries lesions is effective in reducing progression of the lesion.",2020,"The caries progression rate of the control group was significantly higher than that of the test group (p< 0.05).
","['In 41 of the adolescent and young adults 45 pairs of proximal lesions with radiological extension into the inner and outer half of the enamel, or into the outer third of the dentin', 'Forty-one patients, aged 15 to 33 years, with 2 or more non-cavitated proximal caries lesions were included']","['test groups (resin infiltration application + fluoridated toothpaste and flossing use) or to the control group (fluoridated toothpaste and flossing use', 'resin infiltration', 'Resin Infiltration']","['radiographic progression of the lesions', 'caries progression rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}]",41.0,0.0412558,"The caries progression rate of the control group was significantly higher than that of the test group (p< 0.05).
","[{'ForeName': 'Soley', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Erciyes University, Kayseri, Turkey, soley@erciyes.edu.tr.'}, {'ForeName': 'Melek Hilal', 'Initials': 'MH', 'LastName': 'Kaplan', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000503053']
2465,12002292,"Hysteroscopic endometrial destruction, optimum method for preoperative endometrial preparation: a prospective, randomized, multicenter evaluation.","OBJECTIVE
To compare the outcome and cost-effectiveness of various forms of preoperative endometrial preparation prior to hysteroscopic endometrial destruction for abnormal uterine bleeding.
METHODS
This was a multicenter, prospective, comparative, randomized study conducted in a tertiary care hospital in Cairo, Egypt and 2 academic tertiary care teaching hospitals in the United States. One hundred thirty-one premenopausal women, who had completed childbearing, mean age of 45.7 years, with abnormal uterine bleeding refractory to medical management without histologic evidence of endometrial neoplasia were studied. The 131 patients were randomized for preoperative preparation for hysteroscopic endometrial destruction into 1 of 5 groups as follows: Group I, dilation and curettage (D & C) (39); Group II, gonadotropin-releasing hormone analogue (GnRHa) for 1 month (23); Group III, GnRHa for 3 months (26); Group IV, danazol for 3 months (26); and Group V, medroxyprogesterone acetate (MPA) 15 mg for 3 months (27). The choice of endometrial ablation or endometrial resection was left to the surgeon.
RESULTS
Improvement in bleeding patterns, amenorrhea, operative times, complications, and relative cost were the measured outcomes. The mean follow-up time was 1 year from the time of the procedure. Overall, in Group I, 39/39 (100%) improved and 7/39 (18.0%) experienced amenorrhea; in Group II, 21/23 (91.3%) improved and 9/23 (39.1%) experienced amenorrhea; in Group III, 24/26 (92.3%) improved and 10/26 (38.5%) experienced amenorrhea; in Group IV, 24/26 (92.3%) improved and 9/26 (34.6%) experienced amenorrhea; and in Group V, 23/27 (85.1%) improved and 7/27 (25.9%) experienced amenorrhea.
CONCLUSION
Endometrial destruction whether by the ablation or resection technique, regardless of the type of surgical pretreatment is a safe and effective surgical approach for treating abnormal uterine bleeding. D & C or MPA appear to be the most cost-effective pretreatment regimens. MPA pretreatment may confer the added advantage of decreasing blood flow and allowing better hysteroscopic visualization than D & C pretreatment.",2002,"Endometrial destruction whether by the ablation or resection technique, regardless of the type of surgical pretreatment is a safe and effective surgical approach for treating abnormal uterine bleeding.","['tertiary care hospital in Cairo, Egypt and 2 academic tertiary care teaching hospitals in the United States', 'One hundred thirty-one premenopausal women, who had completed childbearing, mean age of 45.7 years, with abnormal uterine bleeding refractory to medical management without histologic evidence of endometrial neoplasia were studied', '131 patients']","['preoperative endometrial preparation prior to hysteroscopic endometrial destruction', 'dilation and curettage (D & C) (39); Group II, gonadotropin-releasing hormone analogue (GnRHa', 'danazol', 'MPA', 'medroxyprogesterone acetate (MPA', 'endometrial ablation or endometrial resection']","['blood flow', 'bleeding patterns, amenorrhea, operative times, complications, and relative cost', 'amenorrhea']","[{'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0014170', 'cui_str': 'Endometrial Neoplasms'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure (procedure)'}, {'cui': 'C0012358', 'cui_str': 'D&C'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues, endocrine therapy drugs'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0341803', 'cui_str': 'Endometrial Ablation'}, {'cui': 'C0404115', 'cui_str': 'Endometrial resection (procedure)'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",131.0,0.0288695,"Endometrial destruction whether by the ablation or resection technique, regardless of the type of surgical pretreatment is a safe and effective surgical approach for treating abnormal uterine bleeding.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Shawki', 'Affiliation': 'Unit of Advanced Laparoscopic Surgery, Al Ebtesama Hospital, Heliopolis, Cairo, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Abraham-Hebert', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2466,12002290,Comparison of immune preservation between CO2 pneumoperitoneum and gasless abdominal lift laparoscopy.,"OBJECTIVE
Carbon dioxide (CO2) pneumoperitoneum has been implicated as a possible factor in early immune preservation in laparoscopic surgery. Although the current analysis was not adequate to clarify this issue, the aim of this study was to compare CO2 insufflation laparoscopic cholecystectomy to gasless abdominal wall lift laparoscopic cholecystectomy with respect to preservation of the immune system.
METHOD
An analysis of the temporal immune responses was performed in 2 similar groups of patients (n = 50) who were divided randomly into the categories of gas or abdominal wall lift laparoscopic cholecystectomy. The patients were matched with respect to age, weight, and operation time. The immune parameters (serum white blood cell count, cortisol, erythrocyte sedimentation rate [ESR], tumor necrosis factor-alpha [TNF-alpha], interferon-y [INF-gamma], interleukin-6 [IL-6], interleukin-8 [IL-8]) were assessed at preoperative 24 hours and at postoperative 24 and 72 hours for the 2 groups. During the operation, the levels of cytokines that were cultured in the peritoneal macrophages were also checked.
RESULTS
The serum white blood cell count, cortisol, and ESR levels were not statistically different in either of the 2 groups. Further, the serum TNF-alpha, INF-gamma, IL-6, and IL-8 levels in both groups were not significantly different from each other at preoperative 24 hours, and postoperative 24 and 72 hours. However, an immediate decrease in the cytokine levels at 24 hours after the operation was significant in both groups. The cytokine levels were particularly higher in the cultured peritoneal macrophages than in the serum, but were not statistically different between the 2 groups.
CONCLUSION
Our results showed that the beneficial immune response obtained in the CO2 gas insufflation laparoscopic procedure could also be obtained in the gasless abdominal wall lift laparoscopic procedure. An immediate preservation of the immune functions in the postoperative period was detected similarly in the 2 groups.",2002,"Further, the serum TNF-alpha, INF-gamma, IL-6, and IL-8 levels in both groups were not significantly different from each other at preoperative 24 hours, and postoperative 24 and 72 hours.",['2 similar groups of patients (n = 50'],"['CO2 insufflation laparoscopic cholecystectomy to gasless abdominal wall lift laparoscopic cholecystectomy', 'CO2 pneumoperitoneum and gasless abdominal lift laparoscopy', 'gas or abdominal wall lift laparoscopic cholecystectomy', 'Carbon dioxide (CO2) pneumoperitoneum']","['serum TNF-alpha, INF-gamma, IL-6, and IL-8 levels', 'serum white blood cell count, cortisol, and ESR levels', 'cytokine levels', 'immune parameters (serum white blood cell count, cortisol, erythrocyte sedimentation rate [ESR], tumor necrosis factor-alpha [TNF-alpha], interferon-y [INF-gamma], interleukin-6 [IL-6], interleukin-8 [IL-8']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]",,0.0196385,"Further, the serum TNF-alpha, INF-gamma, IL-6, and IL-8 levels in both groups were not significantly different from each other at preoperative 24 hours, and postoperative 24 and 72 hours.","[{'ForeName': 'Won Woo', 'Initials': 'WW', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, The Catholic University of Korea, Seoul. lizk@chollian.net""}, {'ForeName': 'Hae Myung', 'Initials': 'HM', 'LastName': 'Jeon', 'Affiliation': ''}, {'ForeName': 'Seung Chul', 'Initials': 'SC', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Sang Kuon', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Chun', 'Affiliation': ''}, {'ForeName': 'Eung Kook', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2467,31288906,Lung Bioposy Without Pleural Drainage.,"BACKGROUND
Video-assisted thoracoscopy and atypical resection of lung parenchyma is a surgical procedure that is carried out very commonly around the world, mainly to determine the degree of malignancy of a suspect pulmonary nodule. A pleural drain is routinely inserted at the end of the procedure. The goal of our study was to evaluate the outcomes of this procedure with and without pleural drainage.
METHODS
From June 2015 to January 2018, 74 patients were prospectively randomized to either the chest-tube group (CT group, 37 patients) or the no-chest-tube group (NCT group, 37 patients) and were followed up until the seventh day after surgery. The postoperative duration of hospital stay was the primary endpoint; the secondary endpoints were the rates of pneumothorax and repeated chest drainage, pain intensity, and analgesic consumption. Blinding was not possible. An intention- to-treat analysis was performed. (Study registration; DRKS00008194, www.drks.de/drks.).
RESULTS
Hospital stays were significantly shorter in the NCT group (means and first and fourth quartiles: 1.5 [1.5; 1.5] versus 2.5 [2.5, 2.5] days, p<0.001). The two groups did not differ significantly with respect to the frequency of postoperative complications. There were two occurrences of postoperative pneumothorax in the NCT group, with one patient needing drainage via chest tube and the other needing no treatment. Pain intensity and analgesic consumption were markedly lower in the NCT group; the cumulative oral intake of metamizole and acetaminophen was also lower in the NCT group (mean ± standard deviation: 3.7 ± 2.2 g in the NCT group versus 10.0 ± 4.2 g in the CT group, p<0.001).
CONCLUSION
Not inserting a chest tube after video-assisted thoracoscopic lung biopsy significantly shortens the postoperative hospital stay, and the complications in the chest-tube and no-chest-tube groups are similar. Postoperative pain and analgesic consumption are markedly less when no chest tube is inserted.",2019,"Pain intensity and analgesic consumption were markedly lower in the NCT group; the cumulative oral intake of metamizole and acetaminophen was also lower in the NCT group (mean ± standard deviation: 3.7 ± 2.2 g in the NCT group versus 10.0 ± 4.2 g in the CT group, p<0.001).
","['From June 2015 to January 2018, 74 patients']","['NCT', 'chest-tube group (CT group, 37 patients) or the no-chest-tube group (NCT']","['postoperative hospital stay', 'postoperative pneumothorax', 'Pain intensity and analgesic consumption', 'Postoperative pain and analgesic consumption', 'rates of pneumothorax and repeated chest drainage, pain intensity, and analgesic consumption', 'Hospital stays', 'cumulative oral intake of metamizole and acetaminophen', 'postoperative duration of hospital stay', 'frequency of postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012586', 'cui_str': 'Metamizole'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",74.0,0.0546485,"Pain intensity and analgesic consumption were markedly lower in the NCT group; the cumulative oral intake of metamizole and acetaminophen was also lower in the NCT group (mean ± standard deviation: 3.7 ± 2.2 g in the NCT group versus 10.0 ± 4.2 g in the CT group, p<0.001).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lesser', 'Affiliation': 'Department of Thoracic-and Vascular Surgery, Lung Cancer Center DKG, SRH Wald-Klinikum Gera, Germany; Department of Cardiothoracic Surgery, University Hospital Jena, Germany; Institute for Medical Statistics, Computer Science, and Data Science, University Hospital Jena, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': ''}, {'ForeName': 'Jerar', 'Initials': 'J', 'LastName': 'Mukdessi', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0329']
2468,12002300,Acute cholecystitis and laparoscopic cholecystectomy.,"OBJECTIVE
To determine whether laparoscopic cholecystectomy (LC) should be the procedure of choice in treating acute cholecystitis.
METHOD
A prospective study was conducted over a 4 1/2-year period. There were 187 patients with acute cholecystitis out of 1020 patients with gallbladder disease who required cholecystectomy. These patients were divided into three groups based on the time interval between the onset of pain and the time patients sought medical attention: Group 1, < 3 days; Group 2, 3 to 7 days; Group 3, > 7 days. All the patients underwent LC after a comprehensive preoperative workup. The parameters analyzed included operating time, hospital stay, and conversion rate. The comparison was made among the various groups and with those who had elective LC.
RESULTS
One hundred twenty patients (64.17%) presented for treatment within 3 to 7 days of the onset of an attack. Empyema of the gallbladder was seen in 106 (56.68%) patients and phlegmon of the gallbladder in 42 (22.46%) patients. Group 3 patients had an operative time of 56.2 min as opposed to 18.5 min in Group 1 and 17.5 min in the elective LC group. The conversion rate in Group 3 was 19.5% versus 3.8% in Group 1 and 3.48% in the elective LC group. The complication rate was 7.3% in Group 3, 3.8% in Group 1, and 3.7% in the elective LC group.
CONCLUSION
Acute cholecystitis is better managed by laparoscopic cholecystectomy, except in the patients presenting with a gallbladder phlegmon later than 7 days after the onset of the attack.",2002,The conversion rate in Group 3 was 19.5% versus 3.8% in Group 1 and 3.48% in the elective LC group.,"['187 patients with acute cholecystitis out of 1020 patients with gallbladder disease who required cholecystectomy', 'One hundred twenty patients (64.17%) presented for treatment within 3 to 7 days of the onset of an attack', 'Acute cholecystitis and laparoscopic cholecystectomy']",['laparoscopic cholecystectomy (LC'],"['Empyema of the gallbladder', 'operative time', 'conversion rate', 'complication rate', 'operating time, hospital stay, and conversion rate']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149520', 'cui_str': 'Acute Cholecystitis'}, {'cui': 'C0016977', 'cui_str': 'Gall Bladder Diseases'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0014009', 'cui_str': 'Empyema'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",1020.0,0.0239924,The conversion rate in Group 3 was 19.5% versus 3.8% in Group 1 and 3.48% in the elective LC group.,"[{'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'M.L.B. Medical College, Jhansi, UP India. sinharga@yahoo.com'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2469,31469393,Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial.,"Importance
Colonoscopy and fecal immunochemical testing (FIT) are considered top-tier tests for colorectal cancer (CRC) screening. Behavioral economic insights about ""choice architecture"" suggest that participation could be influenced by how people are presented test options.
Objective
To investigate response rates for offering colonoscopy only compared with sequential choice (colonoscopy and then FIT) or active choice (colonoscopy or FIT) through mailed outreach.
Design, Setting, and Participants
Three-arm pragmatic randomized clinical trial conducted between November 14, 2017, and May 14, 2018. The setting was primary care practices at an academic health system. Patients aged 50 to 74 years with at least 2 primary care visits in the 2-year preenrollment period were included if they were eligible but not up to date on CRC screening.
Interventions
Eligible patients received mailed outreach about CRC screening. Equal numbers of eligible patients were randomly assigned to 3 outreach groups to receive mailings about CRC screening with the following options: (1) direct phone number to call for scheduling colonoscopy (colonoscopy only), (2) direct phone number to call for colonoscopy and a mailed FIT kit if no response within 4 weeks (sequential choice), or (3) direct phone number to call for colonoscopy and a mailed FIT kit offered at the same time (active choice).
Main Outcomes and Measures
The primary outcome was CRC screening completion (FIT or colonoscopy) within 4 months of initial outreach. The secondary outcomes were CRC screening completion within 6 months of outreach and the choice of colonoscopy as a screening test.
Results
In total, 438 patients were included in the intent-to-treat analysis, with a median age of 56 years (interquartile range, 52-63 years); 55.0% were women. At 4 months, the CRC screening completion rates were 14.4% (95% CI, 8.7%-20.1%) in the colonoscopy-only arm, 17.1% (95% CI, 11.0%-23.2%) in the sequential choice arm, and 19.9% (95% CI, 13.4%-26.4%) in the active choice arm. Neither choice arm achieved a screening rate statistically greater than that in the colonoscopy-alone arm. Among those who completed CRC screening at 4 months, 90.5% (95% CI, 78.0%-103.0%) chose colonoscopy in the colonoscopy-only arm, which was significantly higher than the 52.0% (95% CI, 32.4%-71.6%; P = .005) and 37.9% (95% CI, 20.2%-55.6%; P < .001) in the sequential choice and active choice arms, respectively.
Conclusions and Relevance
There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm. Subtle changes in sequencing or defaults can alter patient decision making related to preventive health.
Trial Registration
ClinicalTrials.gov identifier: NCT03246438.",2019,"There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm.","['438 patients were included in the intent-to-treat analysis, with a median age of 56 years (interquartile range, 52-63 years); 55.0% were women', 'Patients aged 50 to 74 years with at least 2 primary care visits in the 2-year preenrollment period were included if they were eligible but not up to date on CRC screening', 'Colorectal Cancer Screening Outreach', 'Equal numbers of eligible patients', 'Participants\n\n\nThree-arm pragmatic randomized clinical trial conducted between November 14, 2017, and May 14, 2018']","['sequential choice (colonoscopy and then FIT) or active choice (colonoscopy or FIT', 'mailed outreach about CRC screening', 'Importance\n\n\nColonoscopy and fecal immunochemical testing (FIT', 'mailings about CRC screening with the following options: (1) direct phone number to call for scheduling colonoscopy (colonoscopy only), (2) direct phone number to call for colonoscopy and a mailed FIT kit if no response within 4 weeks (sequential choice), or (3) direct phone number to call for colonoscopy and a mailed FIT kit offered at the same time (active choice', 'Sequential or Active Choice']","['CRC screening', 'CRC screening completion rates', 'screening rate', 'rate of colonoscopy', 'CRC screening completion within 6 months of outreach and the choice of colonoscopy as a screening test', 'CRC screening completion (FIT or colonoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property) (qualifier value)'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]",438.0,0.191216,"There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm.","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Vikranth', 'Initials': 'V', 'LastName': 'Induru', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Santos', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McAuliffe', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Orellana', 'Affiliation': 'Clinical Care Associates, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Chyke A', 'Initials': 'CA', 'LastName': 'Doubeni', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.10305']
2470,32439603,The effects of imaginary eating on visual food cue reactivity: An event-related potential study.,"Previous research has demonstrated that imagining consumption of a specific type of food helps individuals to consume less of that food. The present event-related potential study aimed at investigating the underlying neural correlates of this appetite-reducing strategy. A total of 86 women (mean age = 23.65 years) were randomly assigned to one of three imagination conditions. In each condition, they listened to a guided imagery script that either described the eating of 30 colorful button-shaped chocolates (M&Ms), the sorting of 30 M&Ms by color, or the sorting of 30 marbles by color. Subsequently to the imagery task, the participants were presented with images of M&Ms and marbles while their electroencephalogram and craving ratings were recorded. The results showed that imaginary eating did not reduce the appetitive value of M&M pictures. The M&M sorting group reported enhanced craving and showed increased late positivity toward M&M pictures (300-600 ms after picture onset) compared to the two other groups. The present findings indicate that the imagined handling of food increases food cue reactivity and that imaginary eating is not a reliable method to reduce appetite.",2020,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,['86 women (mean age\u202f=\u202f23.65 years'],['imaginary eating'],"['enhanced craving', 'appetitive value of M&M pictures', 'visual food cue reactivity', 'electroencephalogram and craving ratings', 'late positivity toward M&M pictures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",86.0,0.0227251,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,"[{'ForeName': 'Saša', 'Initials': 'S', 'LastName': 'Zorjan', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria; Department of Psychology, Faculty of Arts, University of Maribor, Slovenia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schwab', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}]",Appetite,['10.1016/j.appet.2020.104743']
2471,11394426,Ondansetron versus dehydrobenzoperidol and metoclopramide for management of postoperative nausea in laparoscopic surgery patients.,"BACKGROUND
In this prospective, randomized, double-blind study, we compared the efficacy of ondansetron versus dehydrobenzoperidol (droperidol) or metoclopramide in the treatment of established postoperative nausea and vomiting in 200 adult patients undergoing laparoscopic surgery under general anesthesia.
METHODS
One hundred seventy-three American Society of Anesthesiologists (ASA) I and II patients satisfied inclusion criteria. Fifty-seven patients received ondansetron 4 mg (group O), 57 patients were given droperidol 1.25 mg (group D), and 59 patients received metoclopramide 10 mg (group M). Antiemetic efficacy was compared at 10 minutes and 30 minutes after the administration of the study drug.
RESULTS
At 10 minutes, nausea scores in group O dropped from 8.3 to 3.7, in group D from 8.5 to 5, and in group M from 8.4 to 6.7; (P < 0.05 between the three groups). At 30 minutes, nausea scores were 1.3 in group O, 1.7 in group D, and 5 in group M; (P < 0.05 between group M and the other two groups). In the droperidol group, 25% of patients developed sedation. Patient satisfaction was best with ondansetron.
CONCLUSIONS
Both ondansetron and droperidol were more effective in the treatment of established postoperative nausea and vomiting than was metoclopramide. However, patients were satisfied best with ondansetron, which acts faster and causes less sedation than droperidol.",2001,Both ondansetron and droperidol were more effective in the treatment of established postoperative nausea and vomiting than was metoclopramide.,"['One hundred seventy-three American Society of Anesthesiologists (ASA', 'laparoscopic surgery patients', '200 adult patients undergoing laparoscopic surgery under general anesthesia']","['dehydrobenzoperidol and metoclopramide', 'droperidol', 'metoclopramide', 'ondansetron', 'ondansetron versus dehydrobenzoperidol (droperidol', 'Ondansetron']","['nausea scores', 'postoperative nausea', 'Antiemetic efficacy', 'established postoperative nausea and vomiting', 'sedation']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",200.0,0.263267,Both ondansetron and droperidol were more effective in the treatment of established postoperative nausea and vomiting than was metoclopramide.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dabbous', 'Affiliation': 'Department of Anesthesiology, American University of Beirut, Lebanon.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Khoury', 'Affiliation': ''}, {'ForeName': 'I R', 'Initials': 'IR', 'LastName': 'Chehab', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bartelmaos', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Khoury', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2472,32439189,The Use of Topical Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children: A Randomized Controlled Trial.,"OBJECTIVES
To determine whether the use of topical nitroglycerin patch increases radial artery diameter and facilitate cannulation in children.
DESIGN
Randomized controlled trial.
SETTING
Cairo University Hospital.
PARTICIPANTS
Children aged 2 to 8 years old scheduled for cardiac surgery.
INTERVENTION
In the nitroglycerin group (n = 20), a gauze-covered, half-sized nitroglycerin patch (5 mg) was applied at the site of radial pulsation 1 hour before induction of anesthesia. In the control group (n = 20), a gauze pad was applied to the bare skin at the site of radial pulsation with no intervention.
MEASUREMENTS AND MAIN RESULTS
The primary outcome was the diameter of the radial artery in both limbs using ultrasonography. Other outcomes included the degree of arterial palpability, number of arterial punctures, and incidence of successful first puncture cannulation. The radial artery diameter increased after 30 minutes and 60 minutes compared with the baseline value in the nitroglycerin group in both limbs, whereas no change was reported in the radial artery diameter in the control group. The nitroglycerin group showed a greater incidence of successful first cannulation trial, a fewer number of trials, and a shorter cannulation time compared with the control group. There were no significant hypotensive episodes in any patient.
CONCLUSION
Local application of a half-sized, 5 mg nitroglycerin patch for 60 minutes in children increased the radial artery diameter bilaterally, increased the rate of first trial success, and decreased the time needed for arterial cannulation without significant hypotensive episodes.",2020,"The radial artery diameter increased after 30 minutes and 60 minutes compared with the baseline value in the nitroglycerin group in both limbs, whereas no change was reported in the radial artery diameter in the control group.","['Cairo University Hospital', 'Children', 'Children ages 2 to 8 years old scheduled for cardiac surgery', 'children']","['topical nitroglycerin patch', 'nitroglycerin patch', 'Topical Nitroglycerin', 'nitroglycerin', 'gauze-covered, half-sized nitroglycerin patch']","['radial artery diameter', 'time needed for arterial cannulation', 'shorter cannulation time', 'degree of arterial palpability, number of arterial punctures, and incidence of successful first puncture cannulation', 'incidence of successful first cannulation trial', 'radial artery diameter bilaterally', 'diameter of the radial artery in both limbs using ultrasonography', 'rate of first trial success', 'hypotensive episodes']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0699222', 'cui_str': 'Nitroglycerin Transdermal System'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0520541', 'cui_str': 'Hypotensive episode'}]",,0.261277,"The radial artery diameter increased after 30 minutes and 60 minutes compared with the baseline value in the nitroglycerin group in both limbs, whereas no change was reported in the radial artery diameter in the control group.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Aboelela', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt. Electronic address: maha.mostafa@cu.edu.eg.'}, {'ForeName': 'Rehab Mohamed', 'Initials': 'RM', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Kareem', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.04.035']
2473,31466479,Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator: A Randomized Clinical Trial.,"BACKGROUND
Atrial arrhythmias are common in patients with implantable cardioverter-defibrillator (ICD). External shocks and internal cardioversion through commanded ICD shock for electrical cardioversion are used for rhythm-control. However, there is a paucity of data on efficacy of external versus internal cardioversion and on the risk of lead and device malfunction. We hypothesized that external cardioversion is noninferior to internal cardioversion for safety, and superior for successful restoration of sinus rhythm.
METHODS
Consecutive patients with ICD undergoing elective cardioversion for atrial arrhythmias at 13 centers were randomized in 1:1 fashion to either internal or external cardioversion. The primary safety end point was a composite of surrogate events of lead or device malfunction. Conversion of atrial arrhythmia to sinus rhythm was the primary efficacy end point. Myocardial damage was studied by measuring troponin release in both groups.
RESULTS
N=230 patients were randomized. Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group ( P <0.001). Clinically relevant adverse events caused by external or internal cardioversion were not observed. Three cases of pre-existing silent lead malfunction were unmasked by internal shock, resulting in lead failure. Troponin release did not differ between groups.
CONCLUSIONS
This is the first randomized trial on external vs internal cardioversion in patients with ICDs. External cardioversion was superior for the restoration of sinus rhythm. The unmasking of silent lead malfunction in the internal cardioversion group suggests that an internal shock attempt may be reasonable in selected ICD patients presenting for electrical cardioversion.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.",2019,Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group (p<0.001).,"['patients with implantable cardioverterdefibrillator (ICD', 'Consecutive patients with ICD undergoing elective cardioversion for atrial arrhythmias at 13 centers', 'patients with ICDs', 'selected ICD patients presenting for electrical cardioversion', 'Patients with Implantable Cardioverter-Defibrillator', 'N=230 patients were randomized']","['internal or external cardioversion', 'External cardioversion', 'Internal vs. External Electrical Cardioversion of Atrial Arrhythmia', 'external vs. internal cardioversion', 'External shocks and internal cardioversion through commanded ICD shock', 'external cardioversion']","['Shock efficacy', 'composite of surrogate events of lead or device malfunction', 'troponin release', 'Troponin release', 'Myocardial damage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia (disorder)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia (disorder)'}, {'cui': 'C0419060', 'cui_str': 'Internal electrode cardioversion (procedure)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1504465', 'cui_str': 'Device malfunction'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}]",230.0,0.033156,Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group (p<0.001).,"[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Lüker', 'Affiliation': 'University of Cologne, University Hospital Cologne, Department of Electrophysiology (J.L., A.S., D.S.), Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kuhr', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB) (K.K., S.S.), Germany.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'University of Cologne, University Hospital Cologne, Department of Electrophysiology (J.L., A.S., D.S.), Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Nölker', 'Affiliation': 'Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Clinic for Electrophysiology, Bad Oeynhausen, Germany (G.N., H.O.).'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Omran', 'Affiliation': 'Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Clinic for Electrophysiology, Bad Oeynhausen, Germany (G.N., H.O.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': 'Department of Electrophysiology, University Heart Center, Hamburg, Germany (S.W.).'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Andrié', 'Affiliation': 'Department of Internal Medicine II, University Hospital Bonn, Germany (R.A., J.W.S.).'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Schrickel', 'Affiliation': 'Department of Internal Medicine II, University Hospital Bonn, Germany (R.A., J.W.S.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Winter', 'Affiliation': 'St. Vinzenz Hospital, Cologne, Germany (S.W.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Vollmann', 'Affiliation': 'Herz- & Gefäßzentrum Göttingen, Germany (D.V.).'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Tilz', 'Affiliation': 'Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.H.H.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jobs', 'Affiliation': 'Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.H.H.).'}, {'ForeName': 'Christian-H', 'Initials': 'CH', 'LastName': 'Heeger', 'Affiliation': 'Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.H.H.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Metzner', 'Affiliation': 'Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (A.M.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Meyer', 'Affiliation': 'Department of Cardiology, Heart Center Oldenburg, European Medical School Oldenburg-Groningen, Germany (S.M.).'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Mischke', 'Affiliation': 'Medical Clinic I, Leopoldina Hospital, Schweinfurt, Germany (K.M.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Napp', 'Affiliation': 'Department of Internal Medicine I, RWTH Aachen University Hospital, Germany (A.N.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fahrig', 'Affiliation': 'Klinikum Leverkusen, Germany (A.F.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Steinhauser', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB) (K.K., S.S.), Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brachmann', 'Affiliation': 'Medical Clinic II, Coburg Hospital, Germany (J.B.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Baldus', 'Affiliation': 'Department of Cardiology (S.B.), Germany.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Center for Heart Rhythm Disorders, South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, Australia (R.M., P.S.).'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Center for Heart Rhythm Disorders, South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, Australia (R.M., P.S.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Steven', 'Affiliation': 'University of Cologne, University Hospital Cologne, Department of Electrophysiology (J.L., A.S., D.S.), Germany.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041320']
2474,31466505,Adding Acoustical to Visual Movement Patterns to Retest Whether Imitation Is Goal- or Pattern-Directed.,"This study compared two different motor skill modeling presentations (with and without goal display) in visual and audio-visual conditions for learning a complex skill (basketball jump shot) to evaluate the importance of (a) audio information and (b) goal observation in motor performance kinematics. Specifically, we sought to understand whether the simultaneous presentation of auditory and visual patterns could usefully direct the learner's attention from goal to pattern stimuli. I selected 40 students ( M age = 20.47 years) who had no prior experience with the basketball jump shot or free throw and randomly assigned them into four groups: Pattern/Visual, Pattern/Audio-Visual, Pattern-Goal/Visual, and Pattern-Goal/Audio-Visual. Participants in the pattern-only groups watched only the skilled motor pattern, while those in the pattern-goal groups watched both the pattern and its outcome. Participants in the visual-only groups simply watched the visual pattern, while those in audio-visual groups saw and heard the pattern; we sonified the angular velocity of the skilled performer's elbow joint. Participants then performed in two conditions with and without balls. On all dependent variables, the participants' performance following the audio-visual presentations was better than when following the visual-only presentations. In addition, the participants' performance in pattern-only groups was better than in pattern-goal groups, but this improved pattern-only performance was far less extensive in the audio-visual than in the visual-only group. In sum, complex motor skill imitation was enhanced by an audio pattern of elbow angular velocity in support of generalist theories of imitation learning.",2020,"In sum, complex motor skill imitation was enhanced by an audio pattern of elbow angular velocity in support of generalist theories of imitation learning.",['I selected 40 students ( M age \u2009=\u200920.47 years) who had no prior experience with the basketball jump shot or free throw and randomly assigned them into four groups'],"['Pattern/Visual, Pattern/Audio-Visual, Pattern-Goal/Visual, and Pattern-Goal/Audio-Visual', 'motor skill modeling presentations (with and without goal display']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]",[],,0.0424025,"In sum, complex motor skill imitation was enhanced by an audio pattern of elbow angular velocity in support of generalist theories of imitation learning.","[{'ForeName': 'Hesam', 'Initials': 'H', 'LastName': 'Ramezanzade', 'Affiliation': 'Department of Sport Science, School of Humanities, Damghan University, Iran.'}]",Perceptual and motor skills,['10.1177/0031512519870418']
2475,32439926,Does Erector Spinae Plane Block Have a Visceral Analgesic Effect?: A Randomized Controlled Trial.,"The visceral analgesic efficacy of erector spinae plane block (ESPB) is still a matter of debate. This study attempted to investigate the visceral analgesic efficacy of ESPB in clinical setting. After randomized, we performed ultrasound-guided bilateral rectus sheath block (RSB), which was aimed to prevent postoperative somatic pain on all patients who underwent laparoscopic cholecystectomy (LC). Ultrasound-guided bilateral ESPB at T7 level was performed only to the intervention group to provide the visceral analgesic block. The intraoperative requirement for remifentanil (P = 0.021) and the cumulative fentanyl consumption at postoperative 24-hours was significantly lower in the ESPB group (206.5 ± 82.8 μg vs.283.7 ± 102.4 μg, respectively; P = 0.004) compared to non-ESPB group. The ESPB group consistently showed lower accumulated analgesic consumption compared with those in the non-ESPB group at all observed time-points (all P < 0.05) after 2 hours and the degree of the accumulated analgesic consumption reduction was greater (P = 0.04) during the 24-hour postoperative period. Pain severity was lower in the ESPB group at 6-hours postoperatively. The significantly reduced opioid consumption in ESPB group may imply that while preliminary and in need of confirmation, ESPB has potential visceral analgesic effect. Therefore, performing ESPB solely may be feasible in inducing both somatic and visceral analgesia.",2020,"The intraoperative requirement for remifentanil (P = 0.021) and the cumulative fentanyl consumption at postoperative 24-hours was significantly lower in the ESPB group (206.5 ± 82.8 μg vs.283.7 ± 102.4 μg, respectively; P = 0.004) compared to non-ESPB group.",[],"['ESPB', 'remifentanil', 'erector spinae plane block (ESPB', 'laparoscopic cholecystectomy (LC', 'ultrasound-guided bilateral rectus sheath block (RSB']","['visceral analgesic efficacy', 'analgesic consumption', 'intraoperative requirement', 'Pain severity', 'cumulative fentanyl consumption', 'analgesic consumption reduction', 'opioid consumption']",[],"[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",,0.05068,"The intraoperative requirement for remifentanil (P = 0.021) and the cumulative fentanyl consumption at postoperative 24-hours was significantly lower in the ESPB group (206.5 ± 82.8 μg vs.283.7 ± 102.4 μg, respectively; P = 0.004) compared to non-ESPB group.","[{'ForeName': 'Hye-Mee', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Doo-Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Sung-Moon', 'Initials': 'SM', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Kyu Taek', 'Initials': 'KT', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Sooin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Hyun-Jung', 'Initials': 'HJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Jong-Hyuk', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea. leejhpain@amc.seoul.kr.'}]",Scientific reports,['10.1038/s41598-020-65172-0']
2476,31085679,Effects of Nicotinamide and Lanthanum Carbonate on Serum Phosphate and Fibroblast Growth Factor-23 in CKD: The COMBINE Trial.,"BACKGROUND
Higher serum phosphate and fibroblast growth factor-23 (FGF23) levels may be modifiable to prevent cardiovascular disease in CKD. Short-term studies have reported modest efficacy in phosphate and FGF23 reduction with intestinal phosphate binders in CKD.
METHODS
To investigate effects of lanthanum carbonate (LC; a phosphate binder) and/or nicotinamide (NAM; an inhibitor of active intestinal phosphate transport) on serum phosphate and FGF23 in stage 3b/4 CKD, we conducted a randomized trial among individuals with eGFR 20-45 ml/min per 1.73 m 2 to NAM (750 mg twice daily) plus LC (1000 mg thrice daily), NAM plus LC placebo, LC plus NAM placebo, or double placebo for 12 months. Dual primary end points were change from baseline in serum phosphate and intact FGF23 concentrations.
RESULTS
Mean eGFR for the 205 participants was 32ml/min per 1.73 m 2 . At baseline, serum phosphate was 3.7 mg/dl and median FGF23 was 99 pg/ml (10th, 90th percentiles: 59, 205). Mean rates of change in phosphate increased slightly over 12 months in all groups and did not differ significantly across arms. Similarly, percent changes in FGF23 per 12 months increased for all arms except LC plus placebo, and did not differ significantly across arms. Gastrointestinal symptoms limited adherence. Adverse events rates were similar across arms.
CONCLUSIONS
LC and/or NAM treatment did not significantly lower serum phosphate or FGF23 in stage 3b/4 CKD over 12 months. Although these agents appeared safe, intestinal symptoms limited adherence. Reducing phosphate and FGF23 in nondialysis CKD will require new approaches.",2019,"CONCLUSIONS
LC and/or NAM treatment did not significantly lower serum phosphate or FGF23 in stage","['CKD', 'individuals with eGFR 20-45 ml/min per 1.73 m 2 to']","['LC', 'lanthanum carbonate (LC', 'Nicotinamide and Lanthanum Carbonate', 'nicotinamide (NAM', 'NAM plus LC placebo, LC plus NAM placebo, or double placebo', 'NAM']","['Serum Phosphate and Fibroblast Growth Factor-23', 'serum phosphate and intact FGF23 concentrations', 'Adverse events rates', 'serum phosphate or FGF23', 'Mean rates of change in phosphate']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}]","[{'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0028027', 'cui_str': 'nicotinamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}]",,0.244755,"CONCLUSIONS
LC and/or NAM treatment did not significantly lower serum phosphate or FGF23 in stage","[{'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology-Hypertension, Department of Medicine and joeix@ucsd.edu.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Isakova', 'Affiliation': 'Division of Nephrology and Hypertension.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Larive', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Salt Lake City Veterans Affairs Healthcare System and.'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Raj', 'Affiliation': 'Division of Renal Diseases and Hypertension, George Washington University, Washington, DC.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Salt Lake City Veterans Affairs Healthcare System and.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'Division of Nephrology, Department of Medicine, NorthShore University Health System-University of Chicago, Pritzker School of Medicine, Evanston, Illinois.'}, {'ForeName': 'Linda F', 'Initials': 'LF', 'LastName': 'Fried', 'Affiliation': 'Renal Section.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gassman', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Middleton', 'Affiliation': 'Division of Nephrology.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Flessner', 'Affiliation': 'Division of Kidney, Urologic, and Hematologic Disorders, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland; and.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Denver Nephrology, Denver, Colorado.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Division of Nephrology.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2018101058']
2477,31465307,"Inspiratory Muscle Training After Heart Valve Replacement Surgery Improves Inspiratory Muscle Strength, Lung Function, and Functional Capacity: A RANDOMIZED CONTROLLED TRIAL.","PURPOSE
The aim of this study was to analyze the effects of inspiratory muscle training (IMT) as a therapeutic strategy after heart valve replacement surgery (HVRS).
METHODS
A double-blind, randomized, clinical trial that included patients undergoing elective HVRS, without post-operative complications, were allocated to 2 groups: IMT group (IMT-G) and IMT placebo group (IMT-PG). The IMT started 3 d after surgery and was performed twice daily for 4 wk. Lung function, maximum inspiratory pressure (MIP) as a measure of inspiratory muscle strength, functional capacity, and quality of life were assessed pre-operatively and at the end of training.
RESULTS
The IMT-G recovered pre-operative MIP and lung function values after 4 wk of training. This group also increased the distance walked during the 6-min walk test (6MWD). In the IMT-PG, the values of MIP were below those found pre-operatively, with impairment of lung function and lower 6MWD in the final evaluation. At the end of IMT, MIP was correlated with the 6MWD and with the spirometry variables.
CONCLUSIONS
IMT performed for 4 wk after HVRS was effective in restoring the values of inspiratory muscle strength and lung function to the pre-operative level and increasing the functional capacity assessed by the 6MWD. Furthermore, an association between lung function and functional capacity was observed, demonstrating the clinical relevance of the use of IMT in the rehabilitation process of these patients.",2019,"In the IMT-PG, the values of MIP were below those found pre-operatively, with impairment of lung function and lower 6MWD in the final evaluation.","['heart valve replacement surgery (HVRS', 'patients undergoing elective HVRS, without post-operative complications']","['Inspiratory Muscle Training', 'inspiratory muscle training (IMT', 'IMT', 'IMT group (IMT-G) and IMT placebo']","['lung function and lower 6MWD', 'lung function and functional capacity', 'inspiratory muscle strength, functional capacity, and quality of life', 'Inspiratory Muscle Strength, Lung Function, and Functional Capacity', 'Lung function, maximum inspiratory pressure (MIP', 'distance walked during the 6-min walk test (6MWD', 'values of MIP', 'inspiratory muscle strength and lung function', 'IMT-G recovered pre-operative MIP and lung function values']","[{'cui': 'C0190173', 'cui_str': 'Heart valve replacement (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0034380'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.0252196,"In the IMT-PG, the values of MIP were below those found pre-operatively, with impairment of lung function and lower 6MWD in the final evaluation.","[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Cargnin', 'Affiliation': 'Programa de Pós-graduação em Ciências da Saúde, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil (Ms Cargnin and Dr Dal Lago); Programa de Pós-graduação em Ciências da Reabilitação (UFCSPA), Porto Alegre, Brazil (Drs Karsten and Dal Lago); Departamento de Fisioterapia, Universidade do Estado de Santa Catarina (UDESC), Florianópolis, Brazil (Dr Karsten); Programa de Pós-graduação em Fisioterapia (UDESC), Florianópolis, Brazil (Dr Karsten); Faculdade de Medicina, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil (Dr Guaragna); and Departamento de Fisioterapia (UFCSPA), Porto Alegre, Brazil (Dr Dal Lago).'}, {'ForeName': 'Marlus', 'Initials': 'M', 'LastName': 'Karsten', 'Affiliation': ''}, {'ForeName': 'João Carlos Vieira da Costa', 'Initials': 'JCVDC', 'LastName': 'Guaragna', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Dal Lago', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000409']
2478,31465308,"""Let's Boogie"": FEASIBILITY OF A DANCE INTERVENTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE.","PURPOSE
Exercise is an effective treatment for individuals with chronic obstructive pulmonary disease (COPD); however, lack of adherence to exercise programs is a common barrier. Innovative approaches to exercise are needed to increase patient engagement and adherence. Dance has been shown to benefit populations with neurological conditions. The aim of our study was to investigate the feasibility of a dance intervention in individuals with COPD.
METHODS
Twenty individuals with COPD participated in a 1-hr dance class delivered twice a week for 8 wk. The primary outcome measure of the study was the feasibility determined by enrollment rate, attendance rate, adverse events, and participant satisfaction. Secondary outcomes included functional capacity, balance, anxiety and depression, steps count, and health-related quality of life.
RESULTS
Of the 47 individuals approached, 37 (79%) were interested in the program and 23 (49%) consented to participate and 20 completed the program with no adverse events and a mean attendance rate of 78%. The mean age ± SD of the participants was 73.4 ± 7.6 yr and 70% were females. Participant satisfaction with the program was high and significant improvements were achieved in the 6-min walk test (P = .03), Balance Evaluation Systems Test (BESTest) (P < .01), Chronic Respiratory Disease Questionnaire (P = .001), and the Activities-specific Balance Confidence scale (P = .007).
CONCLUSION
Dance is an enjoyable, safe, and feasible way to exercise for those with COPD. This pilot study will inform the design of a larger randomized controlled trial to determine effectiveness of dance on exercise capacity, balance, and quality of life for people with COPD.",2019,"Participant satisfaction with the program was high and significant improvements were achieved in the 6-min walk test (P = .03), Balance Evaluation Systems Test (BESTest) (P < .01), Chronic Respiratory Disease Questionnaire (P = .001), and the Activities-specific Balance Confidence scale (P = .007).
","['people with COPD', 'Twenty individuals with COPD participated in a 1-hr dance class delivered twice a week for 8 wk', 'individuals with chronic obstructive pulmonary disease (COPD', 'individuals with COPD', 'The mean age ± SD of the participants was 73.4 ± 7.6 yr and 70% were females']",['dance intervention'],"['feasibility determined by enrollment rate, attendance rate, adverse events, and participant satisfaction', 'functional capacity, balance, anxiety and depression, steps count, and health-related quality of life', 'Activities-specific Balance Confidence scale', '6-min walk test', 'Balance Evaluation Systems Test (BESTest', 'mean attendance rate', 'Chronic Respiratory Disease Questionnaire', 'exercise capacity, balance, and quality of life']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}]","[{'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2733457', 'cui_str': 'ABC (activities-specific balance confidence) scale'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire (assessment scale)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",20.0,0.0792223,"Participant satisfaction with the program was high and significant improvements were achieved in the 6-min walk test (P = .03), Balance Evaluation Systems Test (BESTest) (P < .01), Chronic Respiratory Disease Questionnaire (P = .001), and the Activities-specific Balance Confidence scale (P = .007).
","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Wshah', 'Affiliation': 'Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada (Drs Goldstein, and Brooks, Mr Wshah, and Ms Butler); Rehabilitation Sciences Institute (Drs Patterson, Goldstein, and Brooks and Mr Wshah) and Departments of Physical Therapy (Ms Butler and Drs Patterson, Goldstein, and Brooks) and Medicine (Dr Goldstein), University of Toronto, Toronto, Ontario, Canada; School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada (Dr Brooks).'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': ''}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Brooks', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000428']
2479,11394422,Long-term follow-up of a controlled trial of laser laparoscopy for pelvic pain.,"BACKGROUND AND OBJECTIVES
The purpose of this study was to assess the long-term efficacy of laparoscopic laser surgery in the treatment of painful pelvic endometriosis.
METHODS
We conducted a long-term follow-up of 56 patients who had participated in a randomized, double-blind controlled study at a tertiary referral center for the laparoscopic treatment of endometriosis. The patients had pelvic pain, minimal-to-moderate endometriosis, and underwent laser laparoscopy. We asked patients whether they had now achieved satisfactory symptom relief or whether they had received any further medical intervention for their endometriosis. The main outcome measure was continued symptom relief after treatment and subsequent medical history.
RESULTS
Of the original 56 patients, we were able to contact 38 (67.9%). The mean (range) time since operation was 73 months. Painful symptoms had recurred in 28/38 (73.7%) patients at some point since their operation. The median (range) time for recurrence was 19.7 (5-60) months. At the time of follow-up, satisfactory symptom relief was reported in 21/38 (55.3%) patients. The remaining 17/38 (44.7%) patients continued to experience painful symptoms, and eight eventually had a hysterectomy.
CONCLUSIONS
This study suggests that operative laparoscopy can have long-term benefits for the majority of women with pelvic pain due to endometriosis, but because of the small numbers, this study lacks the power to demonstrate this conclusively.",2001,"At the time of follow-up, satisfactory symptom relief was reported in 21/38 (55.3%) patients.","['56 patients who had participated in a randomized, double-blind controlled study at a tertiary referral center for the laparoscopic treatment of endometriosis', 'painful pelvic endometriosis', '56 patients', 'pelvic pain']","['operative laparoscopy', 'laser laparoscopy', 'laparoscopic laser surgery']","['Painful symptoms', 'satisfactory symptom relief', 'symptom relief after treatment and subsequent medical history', 'pelvic pain, minimal-to-moderate endometriosis', 'median (range) time for recurrence', 'mean (range) time since operation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0241880', 'cui_str': 'Pelvic endometriosis'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0023087', 'cui_str': 'Laser Surgery'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",56.0,0.161658,"At the time of follow-up, satisfactory symptom relief was reported in 21/38 (55.3%) patients.","[{'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Jones', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Royal Surrey County Hospital, Guildford, United Kingdom. kjones@rschguilford.freeserve.co.uk'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Haines', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Sutton', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2480,11303989,Laparoscopy in patients with prior surgery: results of the blind approach.,"BACKGROUND AND OBJECTIVES
To compare the complication rate due to blind access laparoscopy between patients with or without a prior history of laparotomy.
METHODS
We examined a prospective record of data on laparoscopic surgeries performed from 1992 to 1998. Only cases in which the Veress needle and the first trocar were inserted through the umbilicus were included in this study. Results issued from patients without previous abdominal surgery (Group I) were compared with those arising from women with prior laparotomy (Group II). A statistical analysis was performed using the Chi-square test or Fisher exact test when appropriate.
RESULTS
One thousand thirty-three laparoscopies were carried out during the study period, 881 of which began with a blind access through the umbilicus. Two hundred two women (19.3%) had an history of abdominal or pelvic surgery. Eight hundred forty-two patients were included in Group I and 39 in Group II. Failure to penetrate into the peritoneal cavity occurred significantly more frequently in Group II (4/39) than in Group I (1/842, P < 0.0001). The insertion of the Veress needle gave rise to 2 complications in Group I and 0 in Group II (P = 1.0). Transumbilical trocar insertion gave rise to 1 complication in each group (1/841 vs. 1/35, P = 0.11). When all events were considered, incidents or accidents were significantly more frequent in Group II (5/39) than in Group I (4/842)(P < 0.0001).
CONCLUSIONS
We recorded a higher rate of incidents/complications due to the Veress needle and trocar insertion in patients with a previous history of laparotomy. An adapted approach should be recommended for these patients.",2001,"Failure to penetrate into the peritoneal cavity occurred significantly more frequently in Group II (4/39) than in Group I (1/842, P < 0.0001).","['patients with a previous history of laparotomy', 'Two hundred two women (19.3%) had an history of abdominal or pelvic surgery', 'Eight hundred forty-two patients', 'patients with or without a prior history of laparotomy', 'One thousand thirty-three laparoscopies were carried out during the study period, 881 of which began with a blind access through the umbilicus', 'patients with prior surgery']","['Laparoscopy', 'Transumbilical trocar insertion']","['complication rate', 'Failure to penetrate into the peritoneal cavity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0041638', 'cui_str': 'Umbilicus'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0457793', 'cui_str': 'Transumbilical (qualifier value)'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205321', 'cui_str': 'Penetrating (qualifier value)'}, {'cui': 'C1704247', 'cui_str': 'Peritoneal Cavity'}]",1033.0,0.0428585,"Failure to penetrate into the peritoneal cavity occurred significantly more frequently in Group II (4/39) than in Group I (1/842, P < 0.0001).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lécuru', 'Affiliation': 'Service de Gynécologie-Obstétrique, H pital Boucicaut, Paris, France. fabrice.lecuru@bcc.ap-hop-paris.fr'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Leonard', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Philippe Jais', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rizk', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Robin', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Taurelle', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2481,30789785,Explaining the Process of Determining Futility Increases Lay Public Acceptance.,"Rationale: National guidelines have laid out a process to conflict resolution in cases of potentially inappropriate medical interventions. Objectives: To determine the association between information about a process-based approach and lay public perceptions of the appropriateness of withholding medically inappropriate interventions. Methods: Respondents from a nationwide sample completed a survey with two adult intensive care unit-based vignettes: one about advanced cancer where doctors told the family that additional chemotherapy would not be offered, and a second case of multiorgan failure after brain hemorrhage where dialysis would not be offered. Participants were randomly assigned to see or not see information about a detailed process for the determination to withhold (second opinion, ethics consultation, exploring transfer to another institution). The primary outcome was the perceived appropriateness of not providing the treatment (four-point scale, dichotomized for analysis, modified Poisson regression), and the secondary outcome was the negative emotional reaction to the case (positive and negative affect schedule, range 1-5, higher is greater negative emotional response, linear regression). Results: A total of 1,191 respondents were included. Providing detailed process information increased the perceived appropriateness of withholding treatment by approximately 10 percentage points in each vignette: (chemotherapy, 75.7-85.4%; dialysis, 68.0-79.3%). Process information remained associated with perceived appropriateness of withholding treatment after adjustment for order effects and prespecified respondent characteristics (chemotherapy: prevalence ratio, 1.13; 95% confidence interval [CI], 1.07-1.19) (dialysis: prevalence ratio, 1.17; 95% CI, 1.10-1.25). Process information was not associated with emotional response to the cases (chemotherapy: β = -0.04; 95% CI, -0.16 to 0.09) (dialysis: β = -0.02; 95% CI, -0.14 to 0.10; both adjusted for order effects). Conclusions: Providing process-based conflict resolution information increased public acceptance of determinations of medical futility, supporting the practice outlined in national consensus statements.",2019,"Process information was not associated with emotional response to the cases (chemotherapy: β = -0.04; 95% CI, -0.16 to 0.09) (dialysis: β = -0.02; 95% CI, -0.14 to 0.10; both adjusted for order effects). ","['A total of 1,191 respondents were included', 'Methods: Respondents from a nationwide sample completed a survey with two adult intensive care unit-based vignettes: one about advanced cancer where doctors told the family that additional']",['chemotherapy'],"['perceived appropriateness of not providing the treatment (four-point scale, dichotomized for analysis, modified Poisson regression', 'negative emotional reaction to the case (positive and negative affect schedule, range 1-5, higher is greater negative emotional response, linear regression', 'emotional response']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C3661900', 'cui_str': 'Not provided (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0222045'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule (assessment scale)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}]",1191.0,0.193047,"Process information was not associated with emotional response to the cases (chemotherapy: β = -0.04; 95% CI, -0.16 to 0.09) (dialysis: β = -0.02; 95% CI, -0.14 to 0.10; both adjusted for order effects). ","[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Bailoor', 'Affiliation': '1 Department of Internal Medicine.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Valley', 'Affiliation': '2 Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kukora', 'Affiliation': '3 Center for Bioethics and Social Sciences in Medicine.'}, {'ForeName': 'Darin B', 'Initials': 'DB', 'LastName': 'Zahuranec', 'Affiliation': '3 Center for Bioethics and Social Sciences in Medicine.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201811-790OC']
2482,32439573,"A commentary on: ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - an open labelled, randomised control trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.0957589,,"[{'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Aneurin Bevan University Health Board, Newport, Wales, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, Wales, United Kingdom; Department of Surgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.041']
2483,31789554,Female drinkers are more sensitive than male drinkers to alcohol-induced heart rate increase.,"The present study examined the acute effect of alcohol and its cues on autonomic and cardiovascular physiology, as indexed by changes in heart rate (HR), in a relatively large sample of healthy young adult men and women. Participants (27-31 years old, final N = 145) were administered an alcoholic beverage ( n = 88; 52 women) or a placebo beverage ( n = 57; 35 women) in a simulated bar. Target breath alcohol concentration (BrAC) was .08 g%. HR was recorded while participants were seated alone during an initial baseline assessment in a lab room; seated with others during preparation and administration of 2 beverages in a simulated bar; and seated alone in the lab room at ascending, peak, and descending BrAC. HR increased over time for participants in both beverage groups during beverage preparation. During beverage consumption, HR decreased over time in those who drank placebo whereas HR increased over time in those who drank alcohol, increasing at a faster rate in women compared to men. HR remained elevated at the ascending, peak, and descending limb assessments only in participants who drank alcohol with HR increasing over time at ascending BrAC in the women but not men. Sex differences in HR under alcohol were not explained by sex differences in body mass index, BrAC, recent alcohol use, or subjective stimulation. Our findings suggest that women may be more sensitive to alcohol-induced increases in HR, especially in environments where alcohol cues are abundant. This may have implications for cardiovascular risks associated with alcohol. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Sex differences in HR under alcohol were not explained by sex differences in body mass index, BrAC, recent alcohol use, or subjective stimulation.","['Participants (27-31 years old, final N = 145', 'healthy young adult men and women', 'Female drinkers']","['placebo', 'placebo beverage', 'alcoholic beverage']","['HR', 'Target breath alcohol concentration (BrAC', 'heart rate (HR']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic Beverages'}]","[{'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",2019.0,0.0349077,"Sex differences in HR under alcohol were not explained by sex differences in body mass index, BrAC, recent alcohol use, or subjective stimulation.","[{'ForeName': 'Roberto U', 'Initials': 'RU', 'LastName': 'Cofresí', 'Affiliation': 'Department of Psychological Sciences, The University of Missouri.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Bartholow', 'Affiliation': 'Department of Psychological Sciences, The University of Missouri.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Fromme', 'Affiliation': 'Department of Psychology, The University of Texas at Austin.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000338']
2484,30575473,Radical Prostatectomy or Watchful Waiting in Prostate Cancer - 29-Year Follow-up.,"BACKGROUND
Radical prostatectomy reduces mortality among men with clinically detected localized prostate cancer, but evidence from randomized trials with long-term follow-up is sparse.
METHODS
We randomly assigned 695 men with localized prostate cancer to watchful waiting or radical prostatectomy from October 1989 through February 1999 and collected follow-up data through 2017. Cumulative incidence and relative risks with 95% confidence intervals for death from any cause, death from prostate cancer, and metastasis were estimated in intention-to-treat and per-protocol analyses, and numbers of years of life gained were estimated. We evaluated the prognostic value of histopathological measures with a Cox proportional-hazards model.
RESULTS
By December 31, 2017, a total of 261 of the 347 men in the radical-prostatectomy group and 292 of the 348 men in the watchful-waiting group had died; 71 deaths in the radical-prostatectomy group and 110 in the watchful-waiting group were due to prostate cancer (relative risk, 0.55; 95% confidence interval [CI], 0.41 to 0.74; P<0.001; absolute difference in risk, 11.7 percentage points; 95% CI, 5.2 to 18.2). The number needed to treat to avert one death from any cause was 8.4. At 23 years, a mean of 2.9 extra years of life were gained with radical prostatectomy. Among the men who underwent radical prostatectomy, extracapsular extension was associated with a risk of death from prostate cancer that was 5 times as high as that among men without extracapsular extension, and a Gleason score higher than 7 was associated with a risk that was 10 times as high as that with a score of 6 or lower (scores range from 2 to 10, with higher scores indicating more aggressive cancer).
CONCLUSIONS
Men with clinically detected, localized prostate cancer and a long life expectancy benefited from radical prostatectomy, with a mean of 2.9 years of life gained. A high Gleason score and the presence of extracapsular extension in the radical prostatectomy specimens were highly predictive of death from prostate cancer. (Funded by the Swedish Cancer Society and others.).",2018,"Among the men who underwent radical prostatectomy, extracapsular extension was associated with a risk of death from prostate cancer that was 5 times as high as that among men without extracapsular extension, and a Gleason score higher than 7 was associated with a risk that was 10 times as high as that with a score of 6 or lower (scores range from 2 to 10, with higher scores indicating more aggressive cancer).
","['695 men with localized prostate cancer to watchful waiting or radical prostatectomy from October 1989 through February 1999 and collected follow-up data through 2017', 'men with clinically detected localized prostate cancer', 'Men with clinically detected, localized prostate cancer', 'By December 31, 2017, a total of 261 of the 347 men in the radical-prostatectomy group and 292 of the 348 men in the watchful-waiting group had']","['Radical prostatectomy', 'Radical Prostatectomy or Watchful Waiting', 'radical prostatectomy', 'radical prostatectomy, extracapsular extension']","['Cumulative incidence and relative risks', 'risk of death from prostate cancer', 'died; 71 deaths']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517733', 'cui_str': '348'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}]",695.0,0.117986,"Among the men who underwent radical prostatectomy, extracapsular extension was associated with a risk of death from prostate cancer that was 5 times as high as that among men without extracapsular extension, and a Gleason score higher than 7 was associated with a risk that was 10 times as high as that with a score of 6 or lower (scores range from 2 to 10, with higher scores indicating more aggressive cancer).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bill-Axelson', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holmberg', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Garmo', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Busch', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Nordling', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Häggman', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Swen-Olof', 'Initials': 'SO', 'LastName': 'Andersson', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andrén', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Steineck', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Hans-Olov', 'Initials': 'HO', 'LastName': 'Adami', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Johansson', 'Affiliation': ""From the Department of Surgical Sciences (A.B.-A., L.H., M.H.), Regional Cancer Center Uppsala Örebro (H.G.), and the Department of Pathology (C.B.), Uppsala University Hospital, Uppsala, the School of Health and Medical Sciences, Örebro University, and the Department of Urology, Örebro University Hospital, Örebro (S.-O.A., O.A., J.-E.J.), the Department of Medical Epidemiology and Biostatistics (H.-O.A.), Karolinska Institutet, Stockholm, and the Division of Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg (G.S.) - all in Sweden; the School of Medicine, Division of Cancer Studies (L.H., H.G.), and the School of Cancer and Pharmaceutical Sciences (L.H.), King's College London, London; the Department of Urology, Helsinki University Hospital (K.T.), and the Department of Pathology, University of Helsinki (S.N.), Helsinki; the Department of Epidemiology, Harvard T.C. Chan School of Public Health, Boston (H.-O.A.); and the Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo (H.-O.A.).""}]",The New England journal of medicine,['10.1056/NEJMoa1807801']
2485,30759467,Comparison between a rotatable sphincterotome and a conventional sphincterotome for selective bile duct cannulation.,"BACKGROUND
Selective biliary cannulation (SBC) is the first challenge of endoscopic retrograde cholangiopancreatography (ERCP), especially for trainees, and a rotatable sphincterotome may be useful to guide the directional axis of the scope and SBC.
METHODS
We performed a prospective randomized single-center trial, enrolling 200 patients with a native papilla who required therapeutic biliary ERCP. Patients were randomly assigned to the rotatable sphincterotome group (n = 100) or the conventional sphincterotome group (n = 100). The primary endpoint was successful SBC by the trainees within 10 minutes.
RESULTS
The early and late cannulation success rates did not differ significantly between the groups ( P = 0.46 and P > 0.99, respectively). For the patients in whom trainees failed to achieve SBC, the rotatable sphincterotome was used as a rescue cannulation technique in four patients from the conventional group; in no patients in the rotatable group was the conventional sphincterotome used for SBC. Post-ERCP pancreatitis (PEP) occurred in 11 patients (5.5 %; 6 mild, 5 moderate); the incidence did not differ significantly between the two groups (rotatable group 3 %, conventional group 8 %; P = 0.21). The two groups were thus combined for evaluation of the factors relating to cannulation difficulty for trainees, which revealed that orientation of the papilla was a significant factor ( P < 0.001).
CONCLUSIONS
The type of sphincterotome used did not affect the success of SBC by trainees. However, orientation of the papilla was revealed to be a significant factor relating to cannulation difficulty for trainees overall.",2019,"The early and late cannulation success rates did not differ significantly between the groups ( P = 0.46 and P > 0.99, respectively).",['200 patients with a native papilla who required therapeutic biliary ERCP'],"['rotatable sphincterotome', 'rotatable sphincterotome and a conventional sphincterotome', 'Selective biliary cannulation (SBC', 'endoscopic retrograde cholangiopancreatography (ERCP', 'conventional sphincterotome']","['late cannulation success rates', 'successful SBC', 'Post-ERCP pancreatitis (PEP']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0183424', 'cui_str': 'Sphincterotome'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}]",200.0,0.040633,"The early and late cannulation success rates did not differ significantly between the groups ( P = 0.46 and P > 0.99, respectively).","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kurita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kudo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Tadamasa', 'Initials': 'T', 'LastName': 'Takemura', 'Affiliation': 'Graduate School of Applied Informatics, University of Hyogo, Kobe Chuo-ku, Hyogo, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Shunjiro', 'Initials': 'S', 'LastName': 'Azuma', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sono', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yamakawa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Koutarou', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nishimura', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Akiyama', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Mayuki', 'Initials': 'M', 'LastName': 'Omatsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Shujiro', 'Initials': 'S', 'LastName': 'Yazumi', 'Affiliation': 'Division of Gastroenterology and Hepatology, Digestive Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}]",Endoscopy,['10.1055/a-0835-5900']
2486,31462579,Communicating about chemicals in cigarette smoke: impact on knowledge and misunderstanding.,"BACKGROUND
The USA must publicly share information about harmful and potentially harmful constituents (chemicals) in tobacco products. We sought to understand whether webpages with chemical information are ""understandable and not misleading to a lay person.""
METHODS
Participants were a national probability sample of US adults and adolescents ( n =1441, 18% smokers). In an online experiment, we randomly assigned participants to view one of the developed webpages (chemical names only, names with quantity ranges, names with visual risk indicators) or no webpage in phase one (between subjects). Participants completed a survey assessing knowledge, misunderstanding, perceived likelihood, perceived severity of health effects from smoking and quit intentions (smokers only). In phase two (within subjects), participants viewed all three webpage formats and reported webpage perceptions (clarity, usability, usefulness) and perceived impact (affect, elaboration, perceived effectiveness).
RESULTS
In phase one, viewing any webpage led to more knowledge of chemicals (48%-54% vs 28% no webpage, p s<0.001) and health harms (77% vs 67% no webpage, p s<0.001). When exposed to any webpage, 5%-23% endorsed misunderstandings that some cigarettes are safer than others. Webpage format did not affect knowledge or reduce misunderstandings. Viewing any webpage led to higher perceived likelihood of experiencing health effects from smoking ( p < 0.001) and, among smokers, greater intentions to quit smoking ( p =0.04). In phase two, where participants viewed all formats, a visual risk indicator led to the highest perceived impact.
CONCLUSIONS
Knowledge of chemicals and health effects can increase after viewing a website. Yet, websites may not correct the misunderstanding that some cigarettes are safer.",2019,"Viewing any webpage led to higher perceived likelihood of experiencing health effects from smoking ( p < 0.001) and, among smokers, greater intentions to quit smoking ( p =0.04).","['Participants were a national probability sample of US adults and adolescents ( n =1441, 18% smokers', 'cigarette smoke']","['webpages (chemical names only, names with quantity ranges, names with visual risk indicators) or no webpage in phase one']","['knowledge of chemicals', 'health harms', 'webpage perceptions (clarity, usability, usefulness) and perceived impact (affect, elaboration, perceived effectiveness', 'intentions to quit smoking']","[{'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0033206', 'cui_str': 'Probability Sample'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.0532091,"Viewing any webpage led to higher perceived likelihood of experiencing health effects from smoking ( p < 0.001) and, among smokers, greater intentions to quit smoking ( p =0.04).","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'M Justin', 'Initials': 'MJ', 'LastName': 'Byron', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': 'Psychology, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA ntb@unc.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054863']
2487,31461776,[French comment on article Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study].,,2019,,['malignant biliary obstruction'],['paclitaxel-eluting biliary metal stent with sodium caprate'],[],"[{'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0441290', 'cui_str': 'Metal stent (physical object)'}, {'cui': 'C0142815', 'cui_str': 'decanoic acid, sodium salt'}]",[],,0.0163294,,[],Endoscopy,['10.1055/a-0978-5782']
2488,10917114,Delayed oral estradiol combined with leuprolide increases endometriosis-related pain.,"OBJECTIVES
To determine if low-dose estrogen replacement can be added to GnRH agonist therapy after three months to reduce hypoestrogenic symptoms while allowing continued relief of pain in patients with endometriosis.
MATERIALS AND METHODS
Thirteen women with endometriosis and pain were treated with six months of leuprolide acetate in a prospective, randomized double-blind placebo controlled study. After three months of therapy, six subjects initiated oral estradiol 1 mg daily, and seven received an identical placebo.
RESULTS
Dysmenorrhea improved in both groups, and dyspareunia significantly improved in the GnRH agonist plus placebo group. The mean pain scores of the oral estrogen group tended to be higher than the placebo group, and hot flushes tended to be less severe with estrogen treatment. However, differences observed between the study and placebo groups did not reach statistical significance.
CONCLUSION
In a prospective, randomized study, low-dose estrogen replacement increases endometriosis-related pain during GnRH agonist therapy. The study was terminated after the first 13 subjects due to the concerning trend toward recurrent symptoms in women who received oral estradiol during GnRH agonist therapy for endometriosis-related pain. With the trend toward increasing pain with estrogen add-back therapy, a larger study would not seem to be justifiable.",2000,"RESULTS
Dysmenorrhea improved in both groups, and dyspareunia significantly improved in the GnRH agonist plus placebo group.","['Thirteen women with endometriosis and pain', 'patients with endometriosis']","['oral estradiol', 'leuprolide', 'placebo', 'leuprolide acetate', 'GnRH agonist therapy', 'GnRH agonist plus placebo', 'estrogen replacement', 'oral estradiol during GnRH agonist therapy']","['dyspareunia', 'mean pain scores', 'endometriosis-related pain', 'hypoestrogenic symptoms', 'Dysmenorrhea']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700596', 'cui_str': 'Leuprolide Acetate'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0086258', 'cui_str': 'Estrogen Replacements'}]","[{'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}]",13.0,0.335674,"RESULTS
Dysmenorrhea improved in both groups, and dyspareunia significantly improved in the GnRH agonist plus placebo group.","[{'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Hurst', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Health Sciences Center, Denver, USA. BSHurst@pop.uky.edu'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Gardner', 'Affiliation': ''}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Tucker', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Awoniyi', 'Affiliation': ''}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schlaff', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2489,11051189,Intraperitoneal bupivacaine does not attenuate pain following laparoscopic cholecystectomy.,"BACKGROUND
Laparoscopic cholecystectomy is characterized by a short hospital stay. Hence, pain control on the day of surgery is increasingly important. The aim of this study was to evaluate the effect of intraperitoneal bupivacaine on pain relief following laparoscopic cholecystectomy.
METHODS
Sixty patients undergoing elective laparoscopic cholecystectomy were prospectively randomized into 2 groups. Following removal of the gallbladder, group A received 100 mg of bupivacaine in 50 cc of saline, installed into the gallbladder bed and right subphrenic space. Group B received saline without bupivacaine. Pain was assessed using a visual/analog scale at fixed-time intervals.
RESULTS
No significant difference occurred in the average pain levels between the groups at 1, 2, 4, and 14 hours postsurgery. The average analgesic requirement was lower in the bupivacaine group, but this did not reach statistical significance.
CONCLUSION
Application of intraperitoneal bupivacaine did not attenuate pain following laparoscopic cholecystectomy, and no role exists for its routine use.",2000,"No significant difference occurred in the average pain levels between the groups at 1, 2, 4, and 14 hours postsurgery.",['Sixty patients undergoing elective laparoscopic cholecystectomy'],"['Laparoscopic cholecystectomy', 'intraperitoneal bupivacaine', 'Intraperitoneal bupivacaine', 'bupivacaine', 'saline without bupivacaine']","['pain', 'average analgesic requirement', 'Pain', 'pain relief', 'average pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",60.0,0.0628124,"No significant difference occurred in the average pain levels between the groups at 1, 2, 4, and 14 hours postsurgery.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Zmora', 'Affiliation': 'Department of Surgery, Chaim Sheba Medical Center, Sackler School of Medicine, Tel Aviv, Israel. Ozmora@hotmail.com'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Stolik-Dollberg', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bar-Zakai', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rosin', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kuriansky', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shabtai', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Perel', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ayalon', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2490,31463720,Gastric myotomy length affects severity but not rate of post-procedure reflux: 3-year follow-up of a prospective randomized controlled trial of double-scope per-oral endoscopic myotomy (POEM) for esophageal achalasia.,"BACKGROUND
Since Inoue performed the first POEM in 2008, safety and efficacy have been well-established. Early studies focused on refining the technique and avoiding incomplete myotomy. Following the discovery that many patients with abnormal acid exposure are asymptomatic, the focus shifted to post-POEM reflux, but no studies have identified any associated procedural factors. In this study, we examined the intermediate-term results of our previous randomized controlled trial, with particular attention to post-POEM reflux.
METHODS
Previously, 100 consecutive patients were randomized to either double- or single-scope POEM. Endoscopy was conducted 2 months post-POEM and annually thereafter. Patients were included in the present study if they completed endoscopy ≥ 6 months post-POEM, and the clinical results of both groups were analyzed with particular attention to clinical efficacy and post-POEM reflux.
RESULTS
Median follow-up was 3 years, and most myotomies were performed in the posterior location. The final gastric myotomy length was longer in the double-scope group (3.3 vs. 2.6 cm). Clinical efficacy (≥ 80%) and rates of post-POEM reflux (~ 60%) were similar; however, there was a higher incidence of moderate esophagitis (Los Angeles Grade B) in the double-scope group (25% vs. 4%). There were no cases of severe esophagitis (Los Angeles Grade C/D). Among patients with normal endoscopy at 2 months, > 40% developed erosive esophagitis on intermediate-term follow-up.
CONCLUSIONS
This is the first study to demonstrate a procedural factor that increases post-POEM esophagitis. Gastric myotomy > 2.5 cm results in increased rates of moderate esophagitis without improving clinical efficacy. Some patients developed esophagitis in a delayed fashion, emphasizing the importance of ongoing surveillance. We also believe that preserving the gastric sling fibers may help to reduce reflux rates. The double-scope method may help to control myotomy length (2.0-2.5 cm) and direction (lesser curve to avoid the gastric sling) to help maximize clinical efficacy while minimizing post-POEM reflux.",2020,The final gastric myotomy length was longer in the double-scope group (3.3 vs. 2.6 cm).,"['100 consecutive patients', 'Patients were included in the present study if they completed endoscopy\u2009≥']","['double-scope per-oral endoscopic myotomy (POEM', 'double- or single-scope POEM']","['rates of post-POEM reflux', 'Clinical efficacy', 'reflux rates', 'erosive esophagitis', 'final gastric myotomy length', 'moderate esophagitis', 'rates of moderate esophagitis', 'severe esophagitis']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0185181', 'cui_str': 'Myotomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0267055', 'cui_str': 'Erosive esophagitis (disorder)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0185181', 'cui_str': 'Myotomy'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",100.0,0.0676675,The final gastric myotomy length was longer in the double-scope group (3.3 vs. 2.6 cm).,"[{'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Grimes', 'Affiliation': 'Department of Surgery, University of Cincinnati College of Medicine, 231 Albert B. Sabin Way, PO Box 670558, Cincinnati, OH, 45267-0558, USA. kevin.grimes@gmail.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bechara', 'Affiliation': ""Division of Gastroenterology, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Shimamura', 'Affiliation': 'Digestive Disease Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruo', 'Initials': 'H', 'LastName': 'Ikeda', 'Affiliation': 'Digestive Disease Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Digestive Disease Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.'}]",Surgical endoscopy,['10.1007/s00464-019-07079-0']
2491,31437413,The Influence of Breastfeeding Peer Support on Breastfeeding Satisfaction Among Japanese Mothers: A Randomized Controlled Trial.,"BACKGROUND
Peer support may help mothers to feel satisfied with their breastfeeding and to continue breastfeeding. However, previous researchers have not examined the influence of peer support on the three breastfeeding-satisfaction domains.
RESEARCH AIM
We aimed to examine the influence of telephone-based peer support on the following three domains of breastfeeding satisfaction among Japanese mothers: maternal satisfaction, perceived benefit to the infant, and lifestyle compatibility with breastfeeding.
METHODS
Breastfeeding mothers were recruited at four maternity hospitals in Japan to participate in a randomized controlled trial. Data were collected 1 month and 4 months postpartum. Among all of the participants ( N = 114), those in the intervention group ( n = 60) received telephone-based peer support until 4 months postpartum, and participants in the control group ( n = 54) received conventional support. Breastfeeding satisfaction was measured using the short version of the revised Japanese Maternal Breastfeeding Evaluation Scale. Generalized estimating equations and effect size analyses were used to examine the influence of the intervention.
RESULTS
On the subscale measuring lifestyle compatibility, participants with peer support had a higher score than those without peer support: regression coefficient 1.54 (95% confidence interval [0.03, 3.04]). The effect size was 0.40 standard deviations among participants with low and mid-level scores at baseline.
CONCLUSION
Although peer support did not change maternal satisfaction or perceived benefit to the infant, it did increase lifestyle compatibility with breastfeeding among these Japanese mothers. This is evidence in favor of increasing the use of peer support.",2020,"On the subscale measuring lifestyle compatibility, participants with peer support had a higher score than those without peer support: regression coefficient 1.54 (95% confidence interval [0.03, 3.04]).","['Japanese Mothers', 'Japanese mothers', 'participants with low and mid-level scores at baseline', 'Breastfeeding mothers were recruited at four maternity hospitals in Japan to participate in a randomized controlled trial']","['Breastfeeding Peer Support', 'conventional support', 'telephone-based peer support', 'telephone-based peer support until 4 months postpartum']","['Breastfeeding satisfaction', 'Japanese Maternal Breastfeeding Evaluation Scale', 'Breastfeeding Satisfaction']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}]",,0.0768733,"On the subscale measuring lifestyle compatibility, participants with peer support had a higher score than those without peer support: regression coefficient 1.54 (95% confidence interval [0.03, 3.04]).","[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Hongo', 'Affiliation': '38551 University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': '38551 University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shibanuma', 'Affiliation': '38551 University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nanishi', 'Affiliation': '38551 University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masamine', 'Initials': 'M', 'LastName': 'Jimba', 'Affiliation': '38551 University of Tokyo, Tokyo, Japan.'}]",Journal of human lactation : official journal of International Lactation Consultant Association,['10.1177/0890334419869601']
2492,31461239,"A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial.","AIMS
Stroke is often a devastating event among patients with heart failure with reduced ejection (HFrEF). In COMMANDER HF, rivaroxaban 2.5 mg b.i.d. did not reduce the composite of first occurrence of death, stroke, or myocardial infarction compared with placebo in patients with HFrEF, coronary artery disease (CAD), and sinus rhythm. We now examine the incidence, timing, type, severity, and predictors of stroke or a transient ischaemic attack (TIA), and seek to establish the net clinical benefit of treatment with low-dose rivaroxaban.
METHODS AND RESULTS
In this double-blind, randomized trial, 5022 patients who had HFrEF(≤40%), elevated natriuretic peptides, CAD, and who were in sinus rhythm were treated with rivaroxaban 2.5 mg b.i.d. or placebo in addition to antiplatelet therapy, after an episode of worsening HF. The primary neurological outcome for this post hoc analysis was time to first event of any stroke or TIA. Over a median follow-up of 20.5 (25th-75th percentiles 20.0-20.9) months, 150 all-cause stroke (127) or TIA (23) events occurred (ischaemic stroke in 82% and haemorrhagic stroke in 11% of stroke events). Overall, 47.5% of first-time strokes were either disabling (16.5%) or fatal (31%). Prior stroke, low body mass index, geographic region, and the CHA2DS2-VASc score were predictors of stroke/TIA. Rivaroxaban significantly reduced the primary neurological endpoint of all-cause stroke or TIA compared with placebo by 32% (1.29 events vs. 1.90 events per 100 patient-years), adjusted for the time from index HF event to randomization and stratified by geographic region (adjusted hazard ratio 0.68, 95% confidence interval 0.49-0.94), with a number needed to treat of 164 patients per year to prevent one stroke/TIA event. The principal safety endpoint of fatal bleeding or bleeding into a critical space, occurred at a similar rate on rivaroxaban and placebo (0.44 events vs. 0.55 events per 100 patient-years).
CONCLUSIONS
Patients with HFrEF and CAD are at risk for stroke or TIA in the period following an episode of worsening heart failure in the absence of atrial fibrillation. Most strokes are of ischaemic origin and nearly half are either disabling or fatal. Rivaroxaban at a dose of 2.5 mg b.i.d. reduced rates of stroke or TIA compared with placebo in this population.
TRIAL REGISTRATION
COMMANDER HF (A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction, or Stroke in Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure); ClinicalTrials.gov NCT01877915.",2019,"Rivaroxaban significantly reduced the primary neurological endpoint of all-cause stroke or TIA compared with placebo by 32% (1.29 events vs. 1.90 events per 100 patient-years), adjusted for the time from index HF event to randomization and stratified by geographic region (adjusted hazard ratio 0.68, 95% confidence interval 0.49–0.94), with a number needed to treat of 164 patients per year to prevent one stroke/TIA event.","['patients with heart failure, coronary artery disease, and sinus rhythm', 'Participants with Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure', 'patients with HFrEF, coronary artery disease (CAD), and sinus rhythm', 'patients with heart failure with reduced ejection (HFrEF', '5022 patients who had HFrEF(≤40%), elevated natriuretic peptides, CAD, and who were in sinus rhythm were treated with']","['placebo', 'rivaroxaban 2.5\u2009mg b.i.d', 'HF ', 'Rivaroxaban', 'rivaroxaban and placebo', 'rivaroxaban']","['composite of first occurrence of death, stroke, or myocardial infarction', 'fatal bleeding or bleeding into a critical space', 'Prior stroke, low body mass index, geographic region, and the CHA2DS2-VASc score', 'Risk of Death, Myocardial Infarction, or Stroke', 'TIA (23) events occurred (ischaemic stroke', 'time to first event of any stroke or TIA', 'primary neurological endpoint of all-cause stroke or TIA', 'reduced rates of stroke or TIA', 'haemorrhagic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C4049268', 'cui_str': 'CHA2DS2-VASc score'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}]",150.0,0.499769,"Rivaroxaban significantly reduced the primary neurological endpoint of all-cause stroke or TIA compared with placebo by 32% (1.29 events vs. 1.90 events per 100 patient-years), adjusted for the time from index HF event to randomization and stratified by geographic region (adjusted hazard ratio 0.68, 95% confidence interval 0.49–0.94), with a number needed to treat of 164 patients per year to prevent one stroke/TIA event.","[{'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Universite de Lorraine, INSERM Unite 1116, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Byra', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Research and Development, Pharmaceuticals, Thrombosis and Hematology Therapeutic Area, Bayer US, LLC, Whippany, NJ, USA.'}, {'ForeName': 'Hsiaowei', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Universite de Lorraine, INSERM Unite 1116, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}]",European heart journal,['10.1093/eurheartj/ehz427']
2493,10772522,Randomized trial comparing a radially expandable needle system with cutting trocars.,"Sharp trocar insertion for laparoscopic procedures carries with it increased risk for vascular and visceral complications and incisional hernia. In a trial, which randomized 87 patients to treatment with either sharp trocars or a radially expanding needle system with blunt dilator, results showed that with the latter system there was statistically improved patient assessment of pain, a lower complications rate, and shorter procedure time. In the group of patients randomized to treatment with conventional trocars, there were a total of six instrument-related adverse events (6/42): four cases (five incidences) of abdominal wall injuries and one small bowel perforation caused by a Veress needle. Of the 45 patients randomized to the blunt dilator/cannula treatment, there was one adverse event (1/45) that was unrelated to the blunt dilator/cannula system: Veress needle injury to abdominal vasculature. The radially expanding access system demonstrates statistically improved patient postoperative comfort and improved patient safety.",2000,"Of the 45 patients randomized to the blunt dilator/cannula treatment, there was one adverse event (1/45) that was unrelated to the blunt dilator/cannula system:",['45 patients randomized to the'],"['blunt dilator/cannula system', 'radially expandable needle system with cutting trocars', 'blunt dilator/cannula treatment']","['abdominal wall injuries and one small bowel perforation', 'patient assessment of pain, a lower complications rate, and shorter procedure time', 'risk for vascular and visceral complications and incisional hernia', 'patient postoperative comfort and improved patient safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0151739', 'cui_str': 'Perforation of small intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0267716', 'cui_str': 'Postoperative Hernia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1113679'}]",87.0,0.0285936,"Of the 45 patients randomized to the blunt dilator/cannula treatment, there was one adverse event (1/45) that was unrelated to the blunt dilator/cannula system:","[{'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Feste', 'Affiliation': ""Texas Women's Hospital, Houston 77054-1989, USA. JoeFeste@classic.msn.com""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bojahr', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Turner', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2494,31461146,"Effect of Prices, Distribution Strategies, and Marketing on Demand for HIV Self-testing in Zimbabwe: A Randomized Clinical Trial.","Importance
HIV self-testing is a promising approach for increasing awareness of HIV status in sub-Saharan Africa, particularly in Zimbabwe, where HIV prevalence is 13%. Evidence is lacking, however, on the optimal pricing policies and delivery strategies for maximizing the effect of HIV self-testing.
Objective
To assess demand for HIV self-testing among adults and priority-population subgroups under alternative pricing and distribution strategies.
Design, Setting, and Participants
This randomized clinical trial recruited study participants between February 15, 2018, and April 25, 2018, in urban and rural communities in Zimbabwe. A factorial design was used to randomize participants to a combination of self-test price, distribution site, and promotional message. Individuals and their household members had to be at least 16 years old to be eligible for participation. This intention-to-treat population comprised 3996 participants.
Interventions
Participants were given a voucher that could be redeemed for an HIV self-test within 1 month at varying prices (US $0-$3) and distribution sites (clinics or pharmacies in urban areas, and retail stores or community health workers in rural areas). Vouchers included randomly assigned promotional messages that emphasized the benefits of HIV testing.
Main Outcomes and Measures
Proportion of participants who obtained self-tests in each trial arm, measured by distributor records.
Results
Among the 4000 individuals enrolled, 3996 participants were included. In total, the mean (SD) age was 35 (14.7) years, and most participants (2841 [71.1%]) were female. Self-testing demand was highly price sensitive; 260 participants (32.5%) who were offered free self-tests redeemed their vouchers, compared with 55 participants (6.9%) who were offered self-tests for US $0.50 (odds ratio [OR], 0.14; 95% CI, 0.10-0.19), a reduction in demand of more than 25 percentage points. Demand was below 3% in the $1, $2, and $3 groups, which was statistically significantly lower than the demand in the free distribution group: in pooled analyses, demand was considerably lower among participants in higher-than-$0 price groups compared with the free distribution group (2.8% vs 32.5%; OR, 0.05; 95% CI, 0.04-0.07). In urban areas, demand was statistically significantly higher with pharmacy-based distribution compared with clinic-based distribution (6.8% vs 2.9%; adjusted OR, 2.78; 95% CI, 1.74-4.45). Price sensitivity was statistically significantly higher among rural residents, men, and those who had never received testing before. Promotional messages did not influence demand.
Conclusions and Relevance
This study found that demand for HIV self-testing in Zimbabwe was highly price sensitive, suggesting that free distribution may be essential for promoting testing among high-priority population groups; additionally, pharmacy-based distribution was preferable to clinic-based distribution in urban areas.
Trial Registration
ClinicalTrials.gov identifier: NCT03559959.",2019,"Demand was below 3% in the $1, $2, and $3 groups, which was statistically significantly lower than the demand in the free distribution group: in pooled analyses, demand was considerably lower among participants in higher-than-$0 price groups compared with the free distribution group (2.8% vs 32.5%; OR, 0.05; 95% CI, 0.04-0.07).","['Zimbabwe', 'participants between February 15, 2018, and April 25, 2018, in urban and rural communities in Zimbabwe', 'In total, the mean (SD) age was 35 (14.7) years, and most participants (2841 [71.1%]) were female', '4000 individuals enrolled, 3996 participants were included', 'adults and priority-population subgroups under alternative pricing and distribution strategies', 'Individuals and their household members had to be at least 16 years old to be eligible for participation', '3996 participants']","['voucher that could be redeemed for an HIV self-test within 1 month at varying prices (US $0-$3) and distribution sites (clinics or pharmacies in urban areas, and retail stores or community health workers in rural areas']",['Price sensitivity'],"[{'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517755', 'cui_str': 'Three thousand nine hundred and ninety-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",260.0,0.0943958,"Demand was below 3% in the $1, $2, and $3 groups, which was statistically significantly lower than the demand in the free distribution group: in pooled analyses, demand was considerably lower among participants in higher-than-$0 price groups compared with the free distribution group (2.8% vs 32.5%; OR, 0.05; 95% CI, 0.04-0.07).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Primrose', 'Initials': 'P', 'LastName': 'Matambanadzo', 'Affiliation': 'CeSHHAR Zimbabwe, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Takaruza', 'Affiliation': 'CeSHHAR Zimbabwe, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hatzold', 'Affiliation': 'Population Services International, Washington, DC.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Cowan', 'Affiliation': 'CeSHHAR Zimbabwe, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Euphemia', 'Initials': 'E', 'LastName': 'Sibanda', 'Affiliation': 'CeSHHAR Zimbabwe, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Division of Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9818']
2495,32441386,Different freezing time of superficial liquid nitrogen cryotherapy in treatment of recalcitrant alopecia areata: Randomized clinical trial.,"Recalcitrant alopecia areata is not uncommon in clinical practice and some patients experienced either treatment failure or recurrence with most of the conventional therapies. Several studies have evaluated the efficacy of cryotherapy in the treatment of alopecia areata with controversial results. This study aimed to optimize the ideal timing of liquid nitrogen cryospraying to achieve the most favorable results. A total of 75 patients with recalcitrant alopecia areata were treated with superficial cryotherapy, two freeze-thaw cycles, each consisted of 3 to 5, 8 to 10, and 13 to 15 seconds in group A, B, and C, respectively. Good to moderate improvement was achieved in 65.2%, 76%, and 76.2% in groups A, B, and C, respectively, with no statistically significant difference. However, the mean percentage of improvement was significantly higher in group B and C compared to group A (P-value < .05 for each). Superficial liquid nitrogen cryotherapy is an effective therapeutic modality for recalcitrant alopecia areata. Moreover, using 8 to 10 seconds dual freeze-thaw cycles is the optimum timing.",2020,"However, the mean percentage of improvement was significantly higher in group B and C compared to group A (p value <0.05 for each).","['75 patients with recalcitrant alopecia areata', 'recalcitrant alopecia areata']","['Superficial liquid nitrogen cryotherapy', 'superficial liquid nitrogen cryotherapy', 'cryotherapy', 'superficial cryotherapy']","['Recalcitrant alopecia areata', 'mean percentage of improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",75.0,0.0145758,"However, the mean percentage of improvement was significantly higher in group B and C compared to group A (p value <0.05 for each).","[{'ForeName': 'Amira A', 'Initials': 'AA', 'LastName': 'Abdel Motaleb', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Assiut University, Asyut, Egypt.'}, {'ForeName': 'Doaa S', 'Initials': 'DS', 'LastName': 'Sayed', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Assiut University, Asyut, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13640']
2496,30334633,Efficacy and safety of secukinumab in Japanese patients with active ankylosing spondylitis: 24-week results from an open-label phase 3 study (MEASURE 2-J).,"Objective: Secukinumab, a fully human monoclonal antibody that neutralizes interleukin-17A, improved the signs and symptoms of ankylosing spondylitis (AS) in three Phase 3 global studies (MEASURE 1, 2, and 3). Here, we describe the efficacy and safety results through Week 24 of a study of secukinumab in Japanese patients with active AS. Methods: In this multicenter, open-label, single arm, 52-week study, 30 AS patients self-administered secukinumab 150 mg subcutaneously at baseline, Weeks 1, 2, 3, and 4, and every 4 weeks thereafter. The primary efficacy endpoint was ASAS 20 response at Week 16. Overall safety and tolerability were assessed beyond Week 24 up to the data reporting cut-off date. Results: The ASAS 20 response rate was 70% (21/30) at Week 16, which was sustained to Week 24. Secukinumab was effective in various clinical outcomes including patient's global assessment of disease activity, spinal pain, nocturnal pain, physical function, spinal mobility, and CRP level. Comparable ASAS 20 and 40 responses were observed regardless of previous anti-TNF therapy. Secukinumab was well-tolerated with a safety profile consistent with previous reports. Conclusion: Secukinumab 150 mg provided sustained improvement in the signs and symptoms of Japanese AS patients through 24 weeks, with no new or unexpected safety signals.",2020,"Secukinumab was effective in various clinical outcomes including patient's global assessment of disease activity, spinal pain, nocturnal pain, physical function, spinal mobility, and CRP level.","['Japanese patients with active ankylosing spondylitis', 'Japanese patients with active AS']","['secukinumab', 'Secukinumab']","['Overall safety and tolerability', ""patient's global assessment of disease activity, spinal pain, nocturnal pain, physical function, spinal mobility, and CRP level"", 'ASAS 20 response rate', 'Efficacy and safety', 'efficacy and safety', 'ASAS 20 response']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0423673', 'cui_str': 'Pain in spine (finding)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",30.0,0.0309967,"Secukinumab was effective in various clinical outcomes including patient's global assessment of disease activity, spinal pain, nocturnal pain, physical function, spinal mobility, and CRP level.","[{'ForeName': 'Mitsumasa', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': ""Immuno-Rheumatology Center, St. Luke's International University and St Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Taniguchi', 'Affiliation': ""Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Fujishige', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Haemmerle', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Brian O', 'Initials': 'BO', 'LastName': 'Porter', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Juntendo Koshigaya Hospital, Juntendo University, Saitama, Japan.'}]",Modern rheumatology,['10.1080/14397595.2018.1538004']
2497,10036122,"Reduction of laparoscopic-induced hypothermia, postoperative pain and recovery room length of stay by pre-conditioning gas with the Insuflow device: a prospective randomized controlled multi-center study.","OBJECTIVE
To assess the efficacy and safety of Insuflow (Georgia BioMedical, Inc.) filter heater hydrator device in reducing the incidence, severity and extent of hypothermia, length of recovery room stay and postoperative pain at the time of laparoscopy.
DESIGN
Prospective, randomized, blinded, controlled multi-center study. Patients underwent gynecologic procedures via laparoscopy; surgeons, anesthesiologists and recovery room personnel assessed the results.
SETTING
Seven North American institutions.
PATIENTS
Seventy-two women for safety evaluation and efficacy studies.
INTERVENTIONS
Intraoperative pre-conditioning of laparoscopic gas with the Insuflow device (treatment) or standard raw gas (control) during laparoscopic surgery and postoperatively.
MAIN OUTCOME MEASURES
Incidence, severity and extent of hypothermia, postoperative pain perception and length of recovery room stay.
RESULTS
The Insuflow group had significantly less intraoperative hypothermia, reduced length of recovery room stay and reduced postoperative pain. Pre-conditioning of laparoscopic gas by filtering heating and hydrating was well tolerated with no adverse effects. The safety profile of the Insuflow pre-conditioned gas showed significant benefits compared to currently used raw gas.
CONCLUSIONS
Pre-conditioning laparoscopic gas by filtering heating and hydrating with the Insuflow device was significantly more effective than the currently used standard raw gas and was safe in reducing or eliminating laparoscopic-induced hypothermia, shortening recovery room length of stay and reducing postoperative pain.",1998,"The Insuflow group had significantly less intraoperative hypothermia, reduced length of recovery room stay and reduced postoperative pain.","['Seventy-two women for safety evaluation and efficacy studies', 'Seven North American institutions']","['Insuflow (Georgia BioMedical, Inc', 'Intraoperative pre-conditioning of laparoscopic gas with the Insuflow device (treatment) or standard raw gas (control) during laparoscopic surgery and postoperatively', 'gynecologic procedures via laparoscopy', 'laparoscopic-induced hypothermia, postoperative pain and recovery room length of stay by pre-conditioning gas with the Insuflow device']","['efficacy and safety', 'intraoperative hypothermia, reduced length of recovery room stay and reduced postoperative pain', 'Incidence, severity and extent of hypothermia, postoperative pain perception and length of recovery room stay', 'postoperative pain', 'incidence, severity and extent of hypothermia, length of recovery room stay and postoperative pain']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1301797', 'cui_str': 'Induced hypothermia (finding)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",72.0,0.0824571,"The Insuflow group had significantly less intraoperative hypothermia, reduced length of recovery room stay and reduced postoperative pain.","[{'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Ott', 'Affiliation': 'Mercer University, School of Engineering, Macon, GA 31207-0001, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Reich', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Love', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McCorvey', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Toledo', 'Affiliation': ''}, {'ForeName': 'C Y', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Syed', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kumar', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2498,31339826,Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study.,"PURPOSE
The PRIMA study (ClinicalTrials.gov identifier: NCT00140582) established that 2 years of rituximab maintenance after first-line immunochemotherapy significantly improved progression-free survival (PFS) in patients with follicular lymphoma compared with observation. Here, we report the final PFS and overall survival (OS) results from the PRIMA study after 9 years of follow-up and provide a final overview of safety.
METHODS
Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma were nonrandomly assigned to receive one of three immunochemotherapy induction regimens. Responding patients were randomly assigned (stratified by induction regimen, response to induction treatment, treatment center, and geographic region) 1:1 to receive 2 years of rituximab maintenance (375 mg/m 2 , once every 8 weeks), starting 8 weeks after the last induction treatment, or observation (no additional treatment). All patients in the extended follow-up provided their written informed consent (data cutoff: December 31, 2016).
RESULTS
In total, 1,018 patients completed induction treatment and were randomly assigned to rituximab maintenance (n = 505) or observation (n = 513). Consent for the extended follow-up was provided by 607 patients (59.6%) of 1,018 (rituximab maintenance, n = 309; observation, n = 298). After data cutoff, median PFS was 10.5 years in the rituximab maintenance arm compared with 4.1 years in the observation arm (hazard ratio, 0.61; 95% CI, 0.52 to 0.73; P < .001). No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40; P = .7948); 10-year OS estimates were approximately 80% in both study arms. No new safety signals were observed.
CONCLUSION
Rituximab maintenance after induction immunochemotherapy provides a significant long-term PFS, but not OS, benefit over observation.",2019,"No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40; P = .7948); 10-year OS estimates were approximately 80% in both study arms.","['Patients With Follicular Lymphoma', 'Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma', 'patients with follicular lymphoma compared with observation', '1,018 patients completed induction treatment']","['immunochemotherapy induction regimens', 'rituximab maintenance', 'Rituximab Maintenance']","['10-year OS estimates', 'final PFS and overall survival (OS', 'median PFS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1449699', 'cui_str': 'Tumor Burden'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1018.0,0.177374,"No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40; P = .7948); 10-year OS estimates were approximately 80% in both study arms.","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bachy', 'Affiliation': 'Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Nancy, Université de Lorraine, INSERM 1256, Nancy, France.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'López-Guillermo', 'Affiliation': 'Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Charles University, Hradec Králové, Czech Republic.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Xerri', 'Affiliation': 'Institut Paoli-Calmettes, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Catalano', 'Affiliation': 'Frankston Hospital and Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lemonnier', 'Affiliation': 'Hôpitaux Universitaires Henri Mondor, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Hospital Universitario de Salamanca-Institute for Biomedical Research of Salamanca, Centro de Investigación Biomédica en Red de Cáncer, Salamanca, Spain.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'Department of Haematology and INSERM 1231, University Hospital F. Mitterrand, Dijon, France.'}, {'ForeName': 'Lars M', 'Initials': 'LM', 'LastName': 'Pedersen', 'Affiliation': 'Herlev University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Dorvaux', 'Affiliation': 'Hôpital de Mercy Centre Hospitalier Régional Metz-Thionville, Metz, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Leppa', 'Affiliation': 'Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gabarre', 'Affiliation': 'Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'da Silva', 'Affiliation': 'Portuguese Institute of Oncology, Lisbon, Portugal.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Glaisner', 'Affiliation': 'Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Ysebaert', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Vekhoff', 'Affiliation': 'Saint Antoine Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Tanin', 'Initials': 'T', 'LastName': 'Intragumtornchai', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Centre de Recherche en Cancérologie et Immunologie Nantes Angers, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lister', 'Affiliation': 'Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Concord Hospital, Concord, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Milone', 'Affiliation': 'Fundaleu, Buenos Aires, Argentina.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sonet', 'Affiliation': 'UCL, Mont-Godinne, Yvoir, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Farhi', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Zeuner', 'Affiliation': 'F Hoffman-La Roche, Basel, Switzerland.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': 'Centre Henri-Becquerel, Rouen, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01073']
2499,31449470,Neoadjuvant Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation Versus Chemoradiation for Locally Advanced Cervical Cancer: A Randomized Phase II Trial.,"PURPOSE
Although chemoradiation therapy (CRT) with cisplatin remains the standard treatment of patients with locally advanced cervical cancer (LACC), 40% of patients present with disease recurrence. Additional treatment strategies are required to improve outcomes. We conducted a trial to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with cisplatin and gemcitabine followed by CRT.
METHODS
In this phase II trial, patients with LACC (International Federation of Gynecology and Obstetrics stage IIB to IVA or with positive lymph nodes) were randomly assigned to three cycles of NAC with cisplatin and gemcitabine followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone. The primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life.
RESULTS
From 107 patients enrolled in the trial, 55 were randomly assigned to the NAC arm and 52 to the CRT-alone arm. The majority of patients had squamous cell carcinoma (87.8%). After a median follow-up of 31.7 months, NAC was associated with an inferior PFS, with 3-year PFS rates of 40.9% v 60.4% in the CRT arm (hazard ratio, 1.84; 95% CI, 1.04 to 3.26; P = .033). NAC also was associated with a lower OS (3-year OS rate, 60.7% v 86.8%; hazard ratio, 2.79; 95% CI, 1.29 to 6.01; P = .006). After treatment completion, complete response rates were 56.3% in the NAC arm and 80.3% in the CRT arm ( P = .008). Toxicities were similar in both arms, with the exception of hypomagnesemia and neuropathy being more common with NAC.
CONCLUSION
This study shows that the addition of NAC consisting of cisplatin and gemcitabine to standard CRT is not superior and is possibly inferior to CRT alone for the treatment of LACC.",2019,"NAC also was associated with a lower OS (3-year OS rate, 60.7% v 86.8%; hazard ratio, 2.79; 95% CI, 1.29 to 6.01; P = .006).","['Locally Advanced Cervical Cancer', '107 patients enrolled in the trial, 55', 'patients with LACC (International Federation of Gynecology and Obstetrics stage IIB to IVA or with positive lymph nodes', 'patients with locally advanced cervical cancer (LACC']","['NAC with cisplatin and gemcitabine followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone', 'neoadjuvant chemotherapy (NAC) with cisplatin and gemcitabine', 'Chemoradiation Versus Chemoradiation', 'cisplatin and gemcitabine', 'Neoadjuvant Chemotherapy With Cisplatin and Gemcitabine', 'chemoradiation therapy (CRT) with cisplatin', 'NAC']","['Toxicities', '3-year PFS rates', '3-year progression-free survival (PFS', 'complete response rates', 'efficacy and safety', 'response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life', 'squamous cell carcinoma']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}]",55.0,0.172895,"NAC also was associated with a lower OS (3-year OS rate, 60.7% v 86.8%; hazard ratio, 2.79; 95% CI, 1.29 to 6.01; P = .006).","[{'ForeName': 'Samantha Cabral S', 'Initials': 'SCS', 'LastName': 'da Costa', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renata Colombo', 'Initials': 'RC', 'LastName': 'Bonadio', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Flavia Carolina G', 'Initials': 'FCG', 'LastName': 'Gabrielli', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Aranha', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Luiza N', 'Initials': 'MLN', 'LastName': 'Dias Genta', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vanessa C', 'Initials': 'VC', 'LastName': 'Miranda', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Freitas', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Abdo Filho', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Patrícia A O', 'Initials': 'PAO', 'LastName': 'Ferreira', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Karime K', 'Initials': 'KK', 'LastName': 'Machado', 'Affiliation': 'Hospital Sírio-Libanês, Brasília, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Scaranti', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Heloísa de A', 'Initials': 'HA', 'LastName': 'Carvalho', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Del Pilar', 'Initials': 'MDP', 'LastName': 'Estevez-Diz', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00674']
2500,31443961,"Docetaxel Versus Surveillance After Radical Radiotherapy for Intermediate- or High-risk Prostate Cancer-Results from the Prospective, Randomised, Open-label Phase III SPCG-13 Trial.","BACKGROUND
Docetaxel combined with androgen deprivation therapy (ADT) has improved patient survival for advanced prostate cancer (PCa).
OBJECTIVE
This randomised trial aimed to evaluate whether six courses of docetaxel improved biochemical disease-free survival (BDFS) after radical radiotherapy (RT) for intermediate- or high-risk PCa patients.
DESIGN, SETTING, AND PARTICIPANTS
A total of 376 patients were randomised in this multinational phase III study, and received either six cycles of adjuvant docetaxel 75 mg/m 2 every 3 wk without continuous prednisone (arm A, n = 188) or surveillance (arm B, n = 188) after RT (NTC006653848). Neoadjuvant/adjuvant ADT was mandatory for all the patients. The primary endpoint was rising prostate-specific antigen (PSA) ≥2 ng/ml above the nadir PSA value. Intermediate- or high-risk PCa was defined as T2 with a Gleason score (GS) of 4 + 3, PSA > 10; T2, GS 8-10, ≤ 70 ng/ml; or any T3. The patients were followed for 5 yr by assessing PSA levels every 3 mo for 2 yr and every 6 mo thereafter.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The study power was 89% to detect a difference in BDFS between groups, and the sample size calculation accounted for the T2/T3 distribution, where a 12%/15% difference in BDFS was assumed for the T2/T3 patients.
RESULTS AND LIMITATIONS
All six cycles were completed in 147 (78%) of the patients in arm A. The median age was 67 yr in both treatment groups, 75% had T3 disease, and 47% had GS 8-10. The median follow-up was 59 mo (range 1-111 mo). The primary endpoint was observed for 58 patients in arm A (docetaxel) and for 57 patients in arm B (surveillance). The Kaplan-Meier analysis showed no difference in the BDFS curves (p = 0.6) between the treatment groups. The 5-yr estimated biochemical progression rates were 31% for arm A and 28% for arm B. Febrile neutropenia occurred in 16% of the docetaxel patients. No deaths were related to the docetaxel treatment. There were 43 deaths during the trial, including 20 in arm A and 23 in arm B, of which nine and seven, respectively, were due to PCa. The hazard ratio from Cox multivariate analysis for PSA progression of arm A (docetaxel) versus arm B (surveillance) was 1.14 (95% confidence interval 0.79-1.64, p = 0.5).
CONCLUSIONS
Adjuvant docetaxel without prednisone did not improve BDFS after radical RT with ADT for intermediate- or high-risk PCa.
PATIENT SUMMARY
We compared six cycles of adjuvant docetaxel given after radical external radiotherapy plus androgen deprivation therapy to surveillance in intermediate- and high-risk localised prostate cancer. We found no overall benefit in this setting.",2019,The Kaplan-Meier analysis showed no difference in the BDFS curves (p = 0.6) between the treatment groups.,"['intermediate- and high-risk localised prostate cancer', 'median age was 67\u202fyr in both treatment groups, 75% had T3 disease, and 47% had GS 8-10', 'advanced prostate cancer (PCa', 'A total of 376 patients', 'intermediate- or high-risk PCa patients']","['adjuvant docetaxel', 'Docetaxel Versus Surveillance', 'Docetaxel combined with androgen deprivation therapy (ADT', 'docetaxel', 'Radical Radiotherapy', 'docetaxel without prednisone', 'radical external radiotherapy plus androgen deprivation therapy', 'radical radiotherapy (RT', 'adjuvant docetaxel 75\u202fmg/m 2 every 3 wk without continuous prednisone', 'Neoadjuvant/adjuvant ADT']","['5-yr estimated biochemical progression rates', 'BDFS curves', 'BDFS', 'biochemical disease-free survival (BDFS', 'Febrile neutropenia']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}]",376.0,0.126569,The Kaplan-Meier analysis showed no difference in the BDFS curves (p = 0.6) between the treatment groups.,"[{'ForeName': 'Pirkko-Liisa', 'Initials': 'PL', 'LastName': 'Kellokumpu-Lehtinen', 'Affiliation': 'Tampere University Hospital, Tampere, Finland. Electronic address: pirkko-liisa.kellokumpu-lehtinen@tuni.fi.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hjälm-Eriksson', 'Affiliation': 'Department of Surgery, Capio S.t Görans Hospital, Stockholm, Sweden; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Thellenberg-Karlsson', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Åström', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Franzen', 'Affiliation': 'Sundsvall University Hospital, Sundsvall, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Fransson', 'Affiliation': 'Gävle Central Hospital, Gävle, Sweden.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Leskinen', 'Affiliation': 'Seinäjoki Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'Mihalj', 'Initials': 'M', 'LastName': 'Zeke', 'Affiliation': 'Växjö Central Hospital, Växjö, Sweden.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Huttunen', 'Affiliation': '4Pharma, Turku, Finland.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Ginman', 'Affiliation': 'Karlstad Central Hospital, Karlstad, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.08.010']
2501,31430226,"Pyrotinib or Lapatinib Combined With Capecitabine in HER2-Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Randomized, Phase II Study.","PURPOSE
Pyrotinib, an irreversible pan-ErbB inhibitor, showed promising antitumor activity and acceptable tolerability in a phase I trial. We assessed the efficacy and tolerability of pyrotinib versus lapatinib, both in combination with capecitabine, in women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer in an open-label, multicenter, randomized phase II study.
PATIENTS AND METHODS
Chinese patients with HER2-positive relapsed or metastatic breast cancer previously treated with taxanes, anthracyclines, and/or trastuzumab were assigned (1:1) to receive 400 mg pyrotinib or lapatinib 1,250 mg orally once per day for 21-day cycles in combination with capecitabine (1,000 mg/m 2 orally twice per day on days 1 to 14). The primary end point was investigator-assessed overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
RESULTS
Between May 29, 2015, and March 15, 2016, 128 eligible patients were randomly assigned to the pyrotinib (n = 65) or lapatinib (n = 63) treatment groups. The overall response rate was 78.5% (95% CI, 68.5% to 88.5%) with pyrotinib and 57.1% (95% CI, 44.9% to 69.4%) with lapatinib (treatment difference, 21.3%; 95% CI, 4.0% to 38.7%; P = .01). The median progression-free survival was 18.1 months (95% CI, 13.9 months to not reached) with pyrotinib and 7.0 months (95% CI, 5.6 to 9.8 months) with lapatinib (adjusted hazard ratio, 0.36; 95% CI, 0.23 to 0.58; P < .001). The most frequent grade 3 to 4 adverse events were hand-foot syndrome in 16 of 65 patients (24.6%) in the pyrotinib group versus 13 of 63 (20.6%) in the lapatinib group; diarrhea in 10 patients (15.4%) versus three patients (4.8%), respectively; and decreased neutrophil count in six patients (9.2%) versus two patients (3.2%), respectively.
CONCLUSION
In women with HER2-positive metastatic breast cancer previously treated with taxanes, anthracyclines, and/or trastuzumab, pyrotinib plus capecitabine yielded statistically significant better overall response rate and progression-free survival than lapatinib plus capecitabine in this randomized phase II trial.",2019,"The median progression-free survival was 18.1 months (95% CI, 13.9 months to not reached) with pyrotinib and 7.0 months (95% CI, 5.6 to 9.8 months) with lapatinib (adjusted hazard ratio, 0.36; 95% CI, 0.23 to 0.58; P < .001).","['HER2-Positive Metastatic Breast Cancer', 'women with HER2-positive metastatic breast cancer', 'Chinese patients with HER2-positive relapsed or metastatic breast cancer previously treated with', 'Between May 29, 2015, and March 15, 2016, 128 eligible patients', 'women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer']","['400 mg pyrotinib or lapatinib', 'capecitabine', 'taxanes, anthracyclines, and/or trastuzumab', 'lapatinib', 'Prior Taxanes, Anthracyclines, and/or Trastuzumab', 'pyrotinib versus lapatinib, both in combination with capecitabine', 'lapatinib plus capecitabine', 'taxanes, anthracyclines, and/or trastuzumab, pyrotinib plus capecitabine', 'Pyrotinib or Lapatinib Combined With Capecitabine']","['investigator-assessed overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1', 'overall response rate and progression-free survival', 'antitumor activity and acceptable tolerability', 'efficacy and tolerability', 'overall response rate', 'median progression-free survival', 'diarrhea', 'neutrophil count']","[{'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",128.0,0.130717,"The median progression-free survival was 18.1 months (95% CI, 13.9 months to not reached) with pyrotinib and 7.0 months (95% CI, 5.6 to 9.8 months) with lapatinib (adjusted hazard ratio, 0.36; 95% CI, 0.23 to 0.58; P < .001).","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': ""National Cancer Center, State Key Laboratory of Molecular Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': ""Hunan Cancer Hospital, Changsha, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""First Affiliated Hospital, Jilin University, Changchun, People's Republic of China.""}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""The Fifth Medical Center of Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Yunjiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Cancer Center of Hebei Province and The Fourth Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China.""}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Tongji Hospital, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': ""Jiangsu Cancer Hospital, Nanjing, People's Republic of China.""}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Jiangsu Hengrui Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Jiangsu Hengrui Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""National Cancer Center, State Key Laboratory of Molecular Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00108']
2502,32441458,"Upper-airway collapsibility and compensatory responses under moderate sedation with ketamine, dexmedetomidine, and propofol in healthy volunteers.","BACKGROUND
Ketamine is a potent sedative drug that helps to maintain upper-airway patency, due to its higher upper-airway dilator muscular activity and higher level of duty cycle, as seen in rats. However, no clinical trials have tested passive upper-airway collapsibility and changes in the inspiratory duty cycle against partial upper-airway obstruction in humans. The present study evaluated both the passive mechanical upper-airway collapsibility and compensatory response against acute partial upper-airway obstruction using three different sedative drugs in a crossover trial.
METHODS
Eight male volunteers entered this nonblinded, randomized crossover study. Upper-airway collapsibility (passive critical closing pressure) and inspiratory duty cycle were measured under moderate sedation with ketamine, propofol, and dexmedetomidine. Propofol, dexmedetomidine, and ketamine anesthesia were induced to obtain adequate, same-level sedation, with a BIS value of 50-70 and the OAA/S score of 2-3 and RASS score of -3.
RESULTS
The median passive critical closing pressure of 0.08 [-5.51 to 1.20] cm H 2 O was not significantly different compared to that of propofol sedation (-0.32 [-1.41 to -0.19] cm H 2 O) and of dexmedetomidine sedation (-0.28 [-0.95 to -0.03] cm H 2 O) (p = .045). The median passive R US for ketamine 54.35 [32.00 to 117.50] cm H 2 O/L/s was significantly higher than that for propofol 5.50 [2.475 to 19.60] cm H 2 O/L/s; (mean difference, 27.50; 95% CI 9.17 to 45.83) (p = .009) and for dexmedetomidine 19.25 [4.125 to 22.05] cm H 2 O/L/s; (mean difference, 22.88; 95% CI 4.67 to 41.09) (p = .021). The inspiratory duty cycle increased significantly as the inspiratory airflow decreased in passive conditions for each sedative drug, but behavior differed among the three sedative drugs.
CONCLUSION
Our findings demonstrate that ketamine sedation may have an advantage of both maintained passive upper-airway collapsibility and a compensatory respiratory response, due to both increase in neuromuscular activity and the increased duty cycle, to acute partial upper-airway obstruction.",2020,O was not significantly different compared to that of propofol sedation (-0.32,"['healthy volunteers', 'Eight male volunteers']","['ketamine', 'Ketamine', 'Propofol, dexmedetomidine, and ketamine anesthesia', 'ketamine, dexmedetomidine, and propofol', 'passive mechanical upper-airway collapsibility and compensatory response against acute partial upper-airway obstruction', 'propofol', 'dexmedetomidine', 'ketamine, propofol, and dexmedetomidine']","['median passive R US', 'Upper-airway collapsibility (passive critical closing pressure) and inspiratory duty cycle', 'inspiratory duty cycle', 'median passive critical closing pressure', 'inspiratory airflow', 'dexmedetomidine sedation', 'neuromuscular activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",8.0,0.0335115,O was not significantly different compared to that of propofol sedation (-0.32,"[{'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Sanuki', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}]",Physiological reports,['10.14814/phy2.14439']
2503,32437937,Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens.,"OBJECTIVES
This study investigated causes of fever in the primary levels of care in Southeast Asia, and evaluated whether C-reactive protein (CRP) could distinguish bacterial from viral pathogens.
METHODS
Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5 °C) or history of fever (<14 days) in Thailand and Myanmar.
RESULTS
Of 773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected. Influenza virus type A was detected in 85/227 cases (37.5%), followed by dengue virus (30 cases, 13.2%), respiratory syncytial virus (24 cases, 10.6%) and Leptospira spp. (nine cases, 4.0%). Clinical outcomes were similar between patients with a bacterial or a viral organism, regardless of antibiotic prescription. CRP was higher among patients with a bacterial organism compared with those with a viral organism (median 18 mg/L, interquartile range [10-49] versus 10 mg/L [≤8-22], p = 0.003), with an area under the curve of 0.65 (95% CI 0.55-0.75).
CONCLUSIONS
Serious bacterial infections requiring antibiotics are an exception rather than the rule in the first line of care. CRP testing could assist in ruling out such cases in settings where diagnostic uncertainty is high and routine antibiotic prescription is common. The original CRP randomised controlled trial was registered with ClinicalTrials.gov, number NCT02758821.",2020,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","['fever in the primary levels of care in Southeast Asia', '773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected', 'Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5˚C) or history of fever (<14 days) in Thailand and Myanmar']",[],"['respiratory syncytial virus', 'CRP']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}]",[],"[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",773.0,0.237316,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: thomas.a@tropmedres.ac.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Myo Maung Maung', 'Initials': 'MMM', 'LastName': 'Swe', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Dittrich', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.'}, {'ForeName': 'Pimnara', 'Initials': 'P', 'LastName': 'Peerawaranun', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pieter W', 'Initials': 'PW', 'LastName': 'Smit', 'Affiliation': 'Maasstad Ziekenhuis Hospital, Department of Medical Microbiology, Rotterdam, The Netherlands; Public Health Laboratory (GGD), Amsterdam, The Netherlands.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Blacksell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Winchell', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Maureen H', 'Initials': 'MH', 'LastName': 'Diaz', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Cambodia-Oxford Medical Research Unit (COMRU), Angkor Hospital for Children, Siem Reap, Cambodia.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.016']
2504,9876706,Analgesia following major gynecological laparoscopic surgery--PCA versus intermittent intramuscular injection.,"BACKGROUND AND OBJECTIVES
To compare the use of patient-controlled analgesia to intermittent intramuscular injections of morphine following major gynecological laparoscopic procedures in order to assess differences in level of pain, sedation, episodes of nausea and/or vomiting, hospitalization time and patient satisfaction with their postoperative analgesia.
METHODS
Seventy-two patients undergoing major gynecological laparoscopic surgery were randomized to receive either postoperative analgesia via intermittent intramuscular injection of morphine (Group 1) or patient controlled analgesia (PCA-Group 2). All patients received anesthesia via a standardized protocol. Postoperative pain levels were recorded via a 10 cm visual analogue scale, and sedation scores were recorded on a standard PCA form. Episodes of nausea and vomiting were also recorded on the same form.
RESULTS
There were no statistically significant differences between intramuscular analgesia and PCA for any of the factors studied. Most significantly it was found that most patients ceased to require either form of parenteral analgesia within 24 hours of their procedure, regardless of the operating time.
CONCLUSION
It is important for the surgeon to be aware of the effects of postoperative analgesia on his or her patients' level of satisfaction. We do not recommend the use of PCA analgesia following major laparoscopic gynecological surgery.",1998,"Most significantly it was found that most patients ceased to require either form of parenteral analgesia within 24 hours of their procedure, regardless of the operating time.
","['major laparoscopic gynecological surgery', 'Seventy-two patients undergoing major gynecological laparoscopic surgery']","['major gynecological laparoscopic surgery--PCA versus intermittent intramuscular injection', 'PCA analgesia', 'morphine', 'postoperative analgesia via intermittent intramuscular injection of morphine (Group 1) or patient controlled analgesia (PCA-Group 2']","['visual analogue scale, and sedation scores', 'Postoperative pain levels', 'level of pain, sedation, episodes of nausea and/or vomiting, hospitalization time and patient satisfaction', 'nausea and vomiting']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",72.0,0.0945302,"Most significantly it was found that most patients ceased to require either form of parenteral analgesia within 24 hours of their procedure, regardless of the operating time.
","[{'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Rosen', 'Affiliation': ""Sydney Women's Endosurgery Centre, St. George Private Hospital, NSW, Australia. swec@tpgi.com.au""}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Carlton', 'Affiliation': ''}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Cario', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McBride', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2505,9876731,Correlation of the end-tidal PCO2 during laparoscopic surgery with the pH of the gastric juice.,"BACKGROUND AND OBJECTIVES
During laparoscopy, the increase of the carbon dioxide tension may increase the synthesis of hydrochloric acid in the parietal cells of the stomach; the source of the secreted hydrogen ions is carbonic acid derived from the hydration of carbon dioxide. The present report tests this hypothesis by correlating the changes of end-tidal PCO2 (ETCO2) with the pH of the gastric juice in patients undergoing laparoscopic cholecystectomy.
METHODS
40 adult patients were investigated: 20 controls, and 20 patients receiving 100 mg nizatidine intravenously, prior to surgery. In both groups, the ETCO2 was measured by capnography and the pH of the gastric juice was monitored before carbon dioxide insufflation and at the end of laparoscopy prior to carbon dioxide deflation.
RESULTS
In the control group, the ETCO2 increased following carbon dioxide insufflation from a mean basal value of 30.2 (standard deviation [SD] 4.6) mm Hg to 41.1 (SD 9.5) mm Hg, while the mean pH of the gastric juice decreased significantly from 1.9 (SD 0.4) to 1.27 (SD 0.43). There was a significant negative correlation between the ETCO2 and pH of the gastric juice (r = -0.4). In the Nizatidine group, the ETCO2 also increased following carbon dioxide insufflation from a mean basal value of 30.9 (SD 3.0) mm Hg to 39.4 (SD 5.3) mm Hg. However, in contrast with the control group, the mean pH of the gastric juice did not decrease, but paradoxically increased from 1.68 (SD 0.36) to 3.6 (SD 1.02).
CONCLUSIONS
During laparoscopy, the pH of the gastric juice is significantly decreased. This decrease is inversely related to the increase of ETCO2. The preoperative administration of the selective H2-blocker nizatidine can prevent the increase in gastric acidity and can result in a paradoxical increase of pH of the gastric juice.",1998,"However, in contrast with the control group, the mean pH of the gastric juice did not decrease, but paradoxically increased from 1.68 (SD 0.36) to 3.6 (SD 1.02).
","['40 adult patients were investigated: 20 controls, and 20 patients receiving 100 mg', 'patients undergoing laparoscopic cholecystectomy']","['Nizatidine', 'carbon dioxide insufflation', 'nizatidine']","['gastric acidity', 'mean pH of the gastric juice', 'ETCO2', 'ETCO2 and pH of the gastric juice']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0085154', 'cui_str': 'Nizatidine'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]","[{'cui': 'C0017120', 'cui_str': 'Gastric acidity, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017133', 'cui_str': 'Gastric Juice'}]",40.0,0.0354994,"However, in contrast with the control group, the mean pH of the gastric juice did not decrease, but paradoxically increased from 1.68 (SD 0.36) to 3.6 (SD 1.02).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baraka', 'Affiliation': 'Department of Anesthesia, American University of Beirut Medical Center, Lebanon.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jabbour-Khoury', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Karam', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Assaf', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kai', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nabbout', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Khoury', 'Affiliation': ''}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,[]
2506,31441100,Brain Vitality Enhancement (BRAVE) program to promote brain health among persons with mild cognitive impairment: A study protocol.,"AIM
This study aims to evaluate the effects of a community-based program entitled 'Brain Vitality Enhancement (BRAVE)' on the cognitive function, physical and mental well-being of persons with mild cognitive impairment.
STUDY DESIGN
This is a parallel wait list randomized controlled trial.
METHODS
The BRAVE program consists of two phases. Phase 1 is an empowerment workshop for training 50 peer mentors to be the exercise ambassadors, while Phase 2 is a supervised exercise program for 250 persons with mild cognitive impairment. They will be randomly allocated to intervention or wait list control groups. For the intervention group, the peer mentors and mentees will be matched according to gender and residential areas to form mentor-mentee groups to attend an 8-week supervised exercise training. The mentor-mentee groups will continue to participate mentor-directed exercise sessions in the community thereafter. A mobile application will be developed for self-directed learning. We hypothesize that persons with mild cognitive impairment receiving the BRAVE program will demonstrate better cognitive function and health-related quality of life than the control group who receive usual care. This study is funded by a grant from the Food and Health Bureau of the Government of Hong Kong Special Administrative Region in April 2018.
DISCUSSION
This study will empower a group of golden-aged adults to be the ambassadors to promote brain health in the community and persons with mild cognitive impairment to integrate moderate-intensity exercise into their lifestyle to achieve long-term beneficial effects on their cognition and well-being.
IMPACT
Given the population with mild cognitive impairment is growing rapidly and expected to keep escalating in coming decades and limited treatment options for cognitive decline and its significant burden on the health and social care system, this study is timely to promote active ageing in the society and reduce the burden associated with cognitive decline.",2019,We hypothesize that persons with mild cognitive impairment receiving the BRAVE program will demonstrate better cognitive function and health-related quality of life than the control group who receive usual care.,"['persons with mild cognitive impairment', 'persons with mild cognitive impairment receiving the', 'group of golden-aged adults', '250 persons with mild cognitive impairment']","['peer mentors and mentees will be matched according to gender and residential areas to form mentor-mentee groups to attend an 8-week supervised exercise training', 'Brain Vitality Enhancement (BRAVE) program', 'community-based program entitled ""Brain Vitality Enhancement (BRAVE', 'BRAVE program']",['cognitive function and health-related quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",250.0,0.0338945,We hypothesize that persons with mild cognitive impairment receiving the BRAVE program will demonstrate better cognitive function and health-related quality of life than the control group who receive usual care.,"[{'ForeName': 'Polly W C', 'Initials': 'PWC', 'LastName': 'Li', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Doris S F', 'Initials': 'DSF', 'LastName': 'Yu', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Parco M', 'Initials': 'PM', 'LastName': 'Siu', 'Affiliation': 'Division of Kinesiology, School of Public Health, Li Ka Shing, Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Schwinger C K', 'Initials': 'SCK', 'LastName': 'Wong', 'Affiliation': 'Evangelical Lutheran Church of Hong Kong, Hong Kong, Hong Kong.'}]",Journal of advanced nursing,['10.1111/jan.14175']
2507,30826975,Role of Social Network Sexual Norms and Behaviors on the HIV Sexual Risk Behaviors of People Who Inject Drugs in HPTN 037.,"This study examined the effect of social network descriptive sexual norms and behaviors on the sexual behaviors of people who inject drugs (PWID). Data from HPTN037 of 232 PWID (egos) and 464 network members (alters) were used in multilevel multivariate logistic regression models. Egos whose alters reported multiple sex partners had greater odds of multiple sex partners (aOR 2.20, 1.13-4.29). Egos' norms of condomless sex with primary (aOR 2.67, 1.15-6.17) and casual (aOR 2.38, 1.01-5.59) partners and egos' norms of giving (aOR 5.52, 1.87-16.25) and receiving (aOR 7.38, 1.34-40.66) money/drugs for sex were associated with the egos' respective behaviors. History of sex between an ego and alter was not associated with increased influence of alters' norms and behaviors on egos' sexual behavior. Findings provide support for developing interventions that target descriptive norms and selective network behavioral characteristics to decrease sexual HIV risk behavior among PWID.",2019,"Egos' norms of condomless sex with primary (aOR 2.67, 1.15-6.17) and casual (aOR 2.38, 1.01-5.59) partners and egos' norms of giving (aOR 5.52, 1.87-16.25) and receiving (aOR 7.38, 1.34-40.66) money/drugs for sex were associated with the egos' respective behaviors.","['People', 'people who inject drugs (PWID']",[],"['HIV Sexual Risk Behaviors', 'sexual HIV risk behavior', ""alters' norms and behaviors on egos' sexual behavior""]","[{'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.0187029,"Egos' norms of condomless sex with primary (aOR 2.67, 1.15-6.17) and casual (aOR 2.38, 1.01-5.59) partners and egos' norms of giving (aOR 5.52, 1.87-16.25) and receiving (aOR 7.38, 1.34-40.66) money/drugs for sex were associated with the egos' respective behaviors.","[{'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Sheehan', 'Affiliation': 'Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University, 11200 SW 8th St, AHC 5, Room 479, Miami, FL, 33199, USA. dsheehan@fiu.edu.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University, 11200 SW 8th St, AHC 5, Room 479, Miami, FL, 33199, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Trepka', 'Affiliation': 'Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University, 11200 SW 8th St, AHC 5, Room 479, Miami, FL, 33199, USA.'}, {'ForeName': 'Laramie R', 'Initials': 'LR', 'LastName': 'Smith', 'Affiliation': 'Division of Global Public Health, University of California San Diego, UCSD School of Medicine, 9500 Gilman Drive #0507, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, 615\xa0N. Wolfe St, Baltimore, MD, 21205, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02409-8']
2508,29807806,Measuring adherence to antipsychotic medications for schizophrenia: Concordance and validity among a community sample in rural China.,"BACKGROUND
Despite the abundance of measures to assess medication adherence by persons suffering schizophrenia, few studies have evaluated their concordance and validity against a reference standard in resource-poor community settings. We explored the concordance and validity of several measures to assess antipsychotic medication adherence in a resource-poor community.
METHOD
Based on a random sample of 278 villagers diagnosed with schizophrenia from Liuyang, Hunan Province, China, we used a concordance correlation coefficient (r c ) and Kappa statistic to assess agreement among pill counts, refill records, clinician rating, Drug Attitude Inventory (DAI), and the Brief Adherence Rating Scale (BARS). The validity of various measures was evaluated by their concordance and sensitivity/specificity to home-based unannounced pill count (UPC) as the reference standard.
RESULTS
The estimated proportion of adherent patients according to all measures (41% ~ 88%) was substantially higher than identified by UPC (35%). Concordance between any two measures was poor (r c /Kappa mostly <0.30). Validity of various measures also was poor against the UPC (r c < 0.20; Kappa <0.16), although refill records and the structured instruments (BARS) performed better than office-based pill counts and clinician impression. BARS, DAI and clinician rating were not sensitive to changes in adherence and would likely underestimate any program effect.
CONCLUSION
In resource-poor community settings, most measures assessed in this study should not be used alone as they overestimated adherence, underestimated program effect, and had poor validity. A combination of UPC and several other measures may provide more insight into clinical trials and programmatic management.",2018,"Validity of various measures also was poor against the UPC (r c < 0.20; Kappa <0.16), although refill records and the structured instruments (BARS) performed better than office-based pill counts and clinician impression.","['community sample in rural China', 'persons suffering schizophrenia', '278 villagers diagnosed with schizophrenia from Liuyang, Hunan Province, China']","['antipsychotic medications', 'UPC']","['BARS, DAI and clinician rating', 'pill counts, refill records, clinician rating, Drug Attitude Inventory (DAI), and the Brief Adherence Rating Scale (BARS']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}]","[{'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0222045'}]",278.0,0.0175272,"Validity of various measures also was poor against the UPC (r c < 0.20; Kappa <0.16), although refill records and the structured instruments (BARS) performed better than office-based pill counts and clinician impression.","[{'ForeName': 'Dong Roman', 'Initials': 'DR', 'LastName': 'Xu', 'Affiliation': 'Sun Yat-sen Global Health Institute (SGHI), School of Public Health and Institute of National Governance of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Xiangya School of Public Health, Central South University, Changsha, Hunan, China. Electronic address: gongwenjie@csu.edu.cn.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gloyd', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Caine', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Simoni', 'Affiliation': 'Department of Phycology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Shuiyuan', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Xiangya School of Public Health, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Statistics, School of Public Health of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bofeng', 'Initials': 'B', 'LastName': 'Dai', 'Affiliation': 'Department of Statistics, School of Public Health of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Xiangya School of Public Health, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Sun Yat-sen Global Health Institute (SGHI), School of Public Health and Institute of National Governance of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}]",Schizophrenia research,['10.1016/j.schres.2018.05.014']
2509,31439323,Quantifying acute physiological biomarkers of transcutaneous cervical vagal nerve stimulation in the context of psychological stress.,"BACKGROUND
Stress is associated with activation of the sympathetic nervous system, and can lead to lasting alterations in autonomic function and in extreme cases symptoms of posttraumatic stress disorder (PTSD). Vagal nerve stimulation (VNS) is a potentially useful tool as a modulator of autonomic nervous system function, however currently available implantable devices are limited by cost and inconvenience.
OBJECTIVE
The purpose of this study was to assess the effects of transcutaneous cervical VNS (tcVNS) on autonomic responses to stress.
METHODS
Using a double-blind approach, we investigated the effects of active or sham tcVNS on peripheral cardiovascular and autonomic responses to stress using wearable sensing devices in 24 healthy human participants with a history of exposure to psychological trauma. Participants were exposed to acute stressors over a three-day period, including personalized scripts of traumatic events, public speech, and mental arithmetic tasks.
RESULTS
tcVNS relative to sham applied immediately after traumatic stress resulted in a decrease in sympathetic function and modulated parasympathetic/sympathetic autonomic tone as measured by increased pre-ejection period (PEP) of the heart (a marker of cardiac sympathetic function) of 4.2 ms (95% CI 1.6-6.8 ms, p < 0.01), decreased peripheral sympathetic function as measured by increased photoplethysmogram (PPG) amplitude (decreased vasoconstriction) by 47.9% (1.4-94.5%, p < 0.05), a 9% decrease in respiratory rate (-14.3 to -3.7%, p < 0.01). Similar effects were seen when tcVNS was applied after other stressors and in the absence of a stressor.
CONCLUSION
Wearable sensing modalities are feasible to use in experiments in human participants, and tcVNS modulates cardiovascular and peripheral autonomic responses to stress.",2020,"RESULTS
tcVNS relative to sham applied immediately after traumatic stress resulted in a decrease in sympathetic function and modulated parasympathetic/sympathetic autonomic tone as measured by increased pre-ejection period (PEP) of the heart (a marker of cardiac sympathetic function) of 4.2 ms (95% CI 1.6-6.8 ms, p < 0.01), decreased peripheral sympathetic function as measured by increased photoplethysmogram (PPG) amplitude (decreased vasoconstriction) by 47.9% (1.4-94.5%, p < 0.05), a 9% decrease in respiratory rate (-14.3 to -3.7%, p < 0.01).",['24 healthy human participants with a history of exposure to psychological trauma'],"['transcutaneous cervical vagal nerve stimulation', 'transcutaneous cervical VNS (tcVNS', 'active or sham tcVNS', 'Vagal nerve stimulation (VNS']","['peripheral sympathetic function', 'peripheral cardiovascular and autonomic responses', 'photoplethysmogram (PPG) amplitude (decreased vasoconstriction', 'respiratory rate', 'sympathetic function and modulated parasympathetic/sympathetic autonomic tone']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C3203533', 'cui_str': 'Psychological Trauma'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]",24.0,0.0459103,"RESULTS
tcVNS relative to sham applied immediately after traumatic stress resulted in a decrease in sympathetic function and modulated parasympathetic/sympathetic autonomic tone as measured by increased pre-ejection period (PEP) of the heart (a marker of cardiac sympathetic function) of 4.2 ms (95% CI 1.6-6.8 ms, p < 0.01), decreased peripheral sympathetic function as measured by increased photoplethysmogram (PPG) amplitude (decreased vasoconstriction) by 47.9% (1.4-94.5%, p < 0.05), a 9% decrease in respiratory rate (-14.3 to -3.7%, p < 0.01).","[{'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA. Electronic address: nil@gatech.edu.'}, {'ForeName': 'Minxuan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Hewon', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Stacy L', 'Initials': 'SL', 'LastName': 'Ladd', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA; Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Md Mobashir H', 'Initials': 'MMH', 'LastName': 'Shandhi', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Shallenberger', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Nye', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Pearce', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, USA; Department of Internal Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, USA; Department of Internal Medicine, Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA; Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA; Coulter Department of Bioengineering, Georgia Institute of Technology, Atlanta, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2019.08.002']
2510,31439338,Antithrombotic Therapy and Cardiovascular Outcomes After Transcatheter Aortic Valve Replacement in Patients With Atrial Fibrillation.,"OBJECTIVES
The study sought to determine the patterns of antithrombotic therapy and association with clinical outcomes in patients with atrial fibrillation (AF) and CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) score ≥2 following transcatheter aortic valve replacement (TAVR).
BACKGROUND
The impact of antithrombotic regimens on clinical outcomes in patients with AF and severe aortic stenosis treated with TAVR is unknown.
METHODS
In the randomized PARTNER II (Placement of Aortic Transcatheter Valve II) trial and associated registries, 1,621 patients with prior AF and CHA 2 DS 2 -VASc score ≥2 comprised the study cohort. Outcomes were analyzed according to antithrombotic therapy.
RESULTS
During the 5-year enrollment period, 933 (57.6%) patients were discharged on oral anticoagulant therapy (OAC). Uninterrupted antiplatelet therapy (APT) for at least 6 months or until an endpoint event was used in 544 of 933 (58.3%) of patients on OAC and 77.5% of patients not on OAC. At 2 years, patients on OAC had a similar rate of stroke (6.6% vs. 5.6%; p = 0.53) and the composite outcome of death or stroke (29.7% vs. 31.8%; p = 0.33), compared with no OAC. OAC with APT was associated with a reduced rate of stroke (5.4% vs. 11.1%; p = 0.03) and death or stroke (29.7% vs. 40.1%; p = 0.01), compared with no OAC or APT. Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not.
CONCLUSIONS
Among patients with prior AF undergoing TAVR, antiplatelet with or without anticoagulant therapy was associated with a reduced risk of stroke at 2 years, implicating multifactorial stroke mechanisms in this population.",2019,"Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not.
","['1,621 patients with prior AF and CHA 2 DS 2 -VASc score\xa0≥2 comprised the study cohort', 'patients with prior AF undergoing TAVR, antiplatelet with or without', 'patients with atrial fibrillation (AF) and CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age\xa0≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) score\xa0≥2 following transcatheter aortic valve replacement (TAVR', 'Patients With Atrial Fibrillation', 'patients with AF and severe aortic stenosis treated with TAVR is unknown']","['antithrombotic regimens', 'Transcatheter Aortic Valve Replacement', 'oral anticoagulant therapy (OAC', 'anticoagulant therapy', 'Uninterrupted antiplatelet therapy (APT']","['death or stroke', 'rate of stroke', 'rates of stroke', 'Antithrombotic Therapy and Cardiovascular Outcomes', 'composite outcome of death or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0003645', 'cui_str': 'APT'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",1621.0,0.0749304,"Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not.
","[{'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: ik2394@cumc.columbia.edu.'}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Alu', 'Affiliation': 'Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Madhavan', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Chakravarty', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Department of Cardiac Surgery, Medstar Heart and Vascular Institute/Georgetown University, Washington, DC.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Biviano', 'Affiliation': 'Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.06.001']
2511,32437921,Central Review of Radiation Therapy Planning Among Patients with Breast-Conserving Surgery: Results from a Quality Assurance Process Integrated into the INSEMA Trial.,"PURPOSE
After publication of the radiation field design in the American College of Surgeons Oncology Group Z0011 trial, a radiation therapy quality assurance review was integrated into the Intergroup-Sentinel-Mamma (INSEMA) trial. We aimed to investigate the role of patient characteristics, extent of axillary surgery, and radiation techniques for dose distribution in ipsilateral axillary levels.
METHODS AND MATERIALS
INSEMA (NCT02466737) has randomized 5542 patients who underwent breast-conserving surgery. Of these, 276 patients from 108 radiation therapy facilities were included in the central review, using the planning records of the first 3 patients treated at each site.
RESULTS
Of the 276 patients, 41 had major deviations (ie, no axillary contouring or submission of insufficient records) leading to exclusion. A total of 235 (85.1%) radiation therapy planning records were delineated according to the INSEMA protocol, including 9 (3.8%) cases with minor deviations. At least 25% of INSEMA patients were unintentionally treated with ≥95% of the prescribed breast radiation dose in axillary level I. Approximately 50% of patients were irradiated with a median radiation dose of more than 85% of prescription dose in level I. Irradiated volumes and applied doses were significantly lower in levels II and III compared with level I. However, 25% of patients still received a median radiation dose of ≥75% of prescription dose to level II. Subgroup analysis revealed a significant association between incidental radiation dose in the axilla and obesity. Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution.
CONCLUSIONS
Assuming ≥80% of prescribed breast dose as the optimal dose for curative radiation of low-volume disease in axillary lymph nodes, at least 50% of reviewed INSEMA patients received an adequate dose in level I, even with contemporary 3-dimensional techniques. Dose coverage was much less in axillary levels II and III, and far below therapeutically relevant doses.",2020,"Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution.
","['axillary lymph nodes', '5,542 patients with breast-conserving surgery', '276 patients', '276 patients from 108 radiotherapy facilities were included in the central review using the planning records of the first three patients treated at each site', 'patients with breast-conserving surgery']","['radiation therapy planning', 'XXX']",[],"[{'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",[],5542.0,0.0393912,"Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution.
","[{'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Radiotherapy, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Angrit', 'Initials': 'A', 'LastName': 'Stachs', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'Potenberg', 'Affiliation': 'Breast Center, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Wolter', 'Affiliation': 'Department of Radiotherapy, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'Department of Obstetrics and Gynecology, Interdisciplinary Breast Center, Esslingen, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Zierhut', 'Affiliation': 'Department of Radio-Oncology and Radiotherapy, Klinikum Hanau GmbH, Hanau, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sedlmayer', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kaiser', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Reitsamer', 'Affiliation': 'Breast Center, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Breast Unit, University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Bekes', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Toralf', 'Initials': 'T', 'LastName': 'Reimer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany. Electronic address: toralf.reimer@med.uni-rostock.de.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.04.042']
2512,31439467,Dosing Iodinated Contrast Media According to Lean Versus Total Body Weight at Abdominal CT: A Stratified Randomized Controlled Trial.,"RATIONALE AND OBJECTIVES
To compare the magnitude and interpatient variability in normalized mean hepatic enhancement (MHE) indices when dosing contrast media (CM) according to total body weight (TBW) and lean body weight (LBW).
MATERIALS AND METHODS
This ethics-approved stratified randomized controlled study allocated 280 outpatients for abdominal Computed Tomography (CT) between February-November 2018 to TBW- or LBW-dosing using computer-generated tables. CTs were acquired in portal venous phase after fixed 35-second injection of Iohexol 350. Patients with missing precontrast image, incorrect dose, or chronic kidney, liver or heart disease were excluded. The number of included patients and CM doses were: TBW arm, 51 women and 60 men, 1.22 mL/kg; LBW arm, 59 women, 1.66 mL/kg LBW, and 59 men, 1.52 mL/kg LBW. Liver attenuations were obtained from regions of interest. Values and standard deviations in MHE indices normalized to iodine dose (MHE/I) and iodine dose per kg TBW (aMHE = MHE/[I/TBW]) were compared (unpaired t tests and F-tests).
RESULTS
Cohorts were similar in age, sex, TBW, and LBW. TBW groups received more CM than LBW groups: men, 106.5 ± 20 versus 98.4 ± 11 mL, p = 0.007; women, 93.7 ± 20 versus 77.5 ± 11 mL, p < 0.0001. TBW and LBW groups showed no significant difference in MHE/I (women, 1.75 ± 0.5 versus 1.86 ± 0.6 HU/g, p = 0.31; men, 1.53 ± 0.4 versus 1.52 ± 0.4 HU/g, p = 0.90) or aMHE (women, 0.03 ± 0.01 versus 0.03 ± 0.01 HU/g/kg, p = 0.25; men, 0.02 ± 0.01 versus 0.02 ± 0.01 HU/g/kg, p = 0.52). Variances in MHE/I and aMHE were not significantly different for all groups (p > 0.05).
CONCLUSION
TBW- and LBW-based CM dosing yield a similar magnitude and interpatient variability in normalized MHE indices at routine abdominal CT.",2020,"I and aMHE were not significantly different for all groups (p > 0.05).
","['51 women and 60 men, 1.22 mL/kg; LBW arm, 59 women, 1.66 mL/kg LBW, and 59 men, 1.52 mL/kg LBW', 'Patients with missing precontrast image, incorrect dose, or chronic kidney, liver or heart disease were excluded', '280 outpatients for abdominal Computed Tomography (CT) between February-November 2018 to TBW- or LBW-dosing using computer-generated tables']","['Iohexol', 'Dosing Iodinated Contrast Media']",['total body weight (TBW) and lean body weight (LBW'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517510', 'cui_str': '1.66 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1706074', 'cui_str': 'Table'}]","[{'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1960405', 'cui_str': 'Iodinated contrast media'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",280.0,0.107393,"I and aMHE were not significantly different for all groups (p > 0.05).
","[{'ForeName': 'Andreu F', 'Initials': 'AF', 'LastName': 'Costa', 'Affiliation': 'Department of Diagnostic Radiology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Victoria General Building, 3rd floor, 1276 South Park Street, Halifax, NS B3H 2Y9, Canda. Electronic address: andreufcosta@gmail.com.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Peet', 'Affiliation': 'Department of Diagnostic Radiology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Victoria General Building, 3rd floor, 1276 South Park Street, Halifax, NS B3H 2Y9, Canda.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdolell', 'Affiliation': 'Department of Diagnostic Radiology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Victoria General Building, 3rd floor, 1276 South Park Street, Halifax, NS B3H 2Y9, Canda.'}]",Academic radiology,['10.1016/j.acra.2019.07.014']
2513,31440823,Randomized open-label phase II trial of 5-day aprepitant plus ondansetron compared to ondansetron alone in the prevention of chemotherapy-induced nausea-vomiting (CINV) in glioma patients receiving adjuvant temozolomide.,"PURPOSE
CINV remains a distressing side effect experienced by glioma patients receiving multi-day temozolomide therapy, in spite of guideline-based antiemetic therapy with selective serotonin-receptor-antagonists. Antiemetic research with aprepitant has routinely excluded glioma patients. In this randomized open-label phase II study, use of a nonstandard 5-day regimen of aprepitant for glioma patients was investigated.
METHODS
One hundred thirty-six glioma patients receiving their first cycle of adjuvant temozolomide (150-200 mg/m 2 /day × 5 days every 28 days) were randomized to Arm-A (ondansetron 8 mg days 1-5 with aprepitant day 1: 125 mg, days 2-5: 80 mg) or Arm-B (ondansetron). Randomization was stratified by tumor grade and number of prior chemotherapy regimens. The primary endpoint was the percentage of patients achieving complete control (CC), defined as no emetic episode or antiemetic rescue medication over the 7-day study period. Secondary endpoints included CINV efficacy in the acute phase (≤ 24 h) and delayed phase (days 2-7), as well as safety and quality of life (QoL).
RESULTS
Patients were 61% male, 97% white, 48% with KPS > 90%, 60% non-smokers, mean age 54, 92% with low alcohol use, and 46% with a CINV history. The CC was 58.6% (Arm-A) and 54.5% (Arm-B). Acute-complete response (CR) rates, defined as CC on day 1 in Arm-A and -B, were 97.1% and 87.9%, respectively (p = 0.056). Treatment-related toxicities were mild or moderate in severity.
CONCLUSIONS
Aprepitant plus ondansetron may increase acute-CR, may have benefit regarding CINV's effect on QoL, and is safe for 5-day temozolomide compared to ondansetron. This study provides no evidence that aprepitant increases CC rate over ondansetron alone.",2020,The CC was 58.6% (Arm-A) and 54.5% (Arm-B).,"['One hundred thirty-six glioma patients receiving their first cycle of', 'glioma patients receiving adjuvant', 'glioma patients receiving multi-day', 'Patients were 61% male, 97% white, 48% with KPS >\u200990%, 60% non-smokers, mean age 54, 92% with low alcohol use, and 46% with a CINV history', '150-200\xa0mg/m']","['5-day aprepitant plus ondansetron', 'ondansetron 8\xa0mg\xa0days 1-5 with aprepitant day 1: 125\xa0mg, days 2-5: 80\xa0mg) or Arm-B (ondansetron', 'temozolomide therapy', 'adjuvant temozolomide', 'temozolomide', 'ondansetron']","['toxicities', 'percentage of patients achieving complete control (CC), defined as no emetic episode or antiemetic rescue medication', 'CINV efficacy in the acute phase (≤\u200924\xa0h) and delayed phase (days 2-7), as well as safety and quality of life (QoL', 'nausea-vomiting (CINV', 'CC rate', 'Acute-complete response (CR) rates']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1596254', 'cui_str': 'Ondansetron 8 MG [Zofran]'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0013973', 'cui_str': 'Emetic Agents'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",136.0,0.033613,The CC was 58.6% (Arm-A) and 54.5% (Arm-B).,"[{'ForeName': 'Mallika P', 'Initials': 'MP', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy, Duke University Hospital, Durham, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Woodring', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Dina M', 'Initials': 'DM', 'LastName': 'Randazzo', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Henry S', 'Initials': 'HS', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Desjardins', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Healy', 'Affiliation': 'Duke Cancer Center Biostatistics, Durham, NC, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Herndon', 'Affiliation': 'Duke Cancer Center Biostatistics, Durham, NC, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'McSherry', 'Affiliation': 'Duke Cancer Center Biostatistics, Durham, NC, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Lipp', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Peters', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Affronti', 'Affiliation': 'Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA. mary.affronti@duke.edu.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05039-x']
2514,31441936,Effect of Different Financial Incentive Structures on Promoting Physical Activity Among Adults: A Randomized Clinical Trial.,"Importance
Few adults engage in recommended levels of physical activity. Financial incentives can promote physical activity, but little is known about how the structure of these incentives influences their effectiveness (eg, how incentives are disbursed over time).
Objective
To determine if it is more effective to disburse fixed total financial incentives at a constant, increasing, or decreasing rate to encourage physical activity.
Design, Setting, and Participants
A 2-week randomized clinical trial was conducted from June 2 to 15, 2014, using an online platform that automatically records daily steps of pedometer-wearing users and awards points redeemable for cash. The study population comprised 3515 adult users of the online platform in the lower 70th percentile of steps taken among all users before treatment. Data analyses were performed from August 20, 2014, to February 1, 2018. Analysis was performed on an intent-to-treat basis.
Interventions
Participants were randomized to either a control group or to 1 of 3 intervention groups during the 2 weeks of the study. Participants in the control group received a constant daily rate of $0.00001 per step. The 3 intervention groups received a 20-fold incentive increase ($0.00020 per step) distributed differently during the 2 weeks of the study: at a constant, increasing, or decreasing rate. Reminder emails explaining incentive schedules were sent the day before the intervention and halfway through the 2-week intervention.
Main Outcomes and Measures
Change in mean daily steps during the 2-week intervention and 3 weeks after the intervention. The study had 80% power to detect a difference of 280 steps per day during the intervention at α = .05.
Results
The study included 3515 participants (879 in the control condition, 879 in the constant incentive condition, 881 in the increasing incentive condition, and 876 in the decreasing incentive condition). During the intervention, compared with participants in the control group, participants receiving constant incentives logged 306.7 more steps per day (95% CI, 91.5-521.9 steps; P = .005), those receiving decreasing incentives logged 96.9 more steps per day (95% CI, 15.3-178.5 steps; P = .02), and those receiving increasing incentives logged no significant change in steps per day (1.5 steps per day; 95% CI, -81.6 to 84.7 steps; P = .97). One week after the intervention, compared with participants in the control group, only participants receiving constant incentives logged significantly more steps per day (329.5; 95% CI, 20.6-638.4; P = .04). Two and 3 weeks after the intervention, there were no significant differences compared with participants in the control group. Overall, for each $1 spent, participants in the constant incentives group logged 475.4 more steps than those in the increasing incentives group and 429.3 more steps than those in the decreasing incentives group.
Conclusions and Relevance
This study found that financial incentives for physical activity were more effective during a payment period when they were offered at a constant rate rather than an increasing or decreasing rate. However, this effectiveness dissipated shortly after the incentives were removed.
Trial Registration
ClinicalTrials.gov identifier: NCT02154256.",2019,"The study had 80% power to detect a difference of 280 steps per day during the intervention at α = .05.
","['Adults', '3515 adult users of the online platform in the lower 70th percentile of steps taken among all users before treatment', '3515 participants (879 in the control condition, 879 in the constant incentive condition, 881 in the increasing incentive condition, and 876 in the decreasing incentive condition']","['Financial Incentive Structures', 'pedometer-wearing users and awards points redeemable for cash']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0004446', 'cui_str': 'Awards'}]",[],3515.0,0.0833909,"The study had 80% power to detect a difference of 280 steps per day during the intervention at α = .05.
","[{'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Bachireddy', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Joung', 'Affiliation': 'Operations, Information and Decisions Department, The Wharton School of the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Leslie K', 'Initials': 'LK', 'LastName': 'John', 'Affiliation': 'Negotiation, Organizations and Markets Unit, Harvard Business School, Boston, Massachusetts.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gino', 'Affiliation': 'Negotiation, Organizations and Markets Unit, Harvard Business School, Boston, Massachusetts.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Tuckfield', 'Affiliation': 'Operations, Information and Decisions Department, The Wharton School of the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Foschini', 'Affiliation': 'Evidation Health Inc, Santa Barbara, California.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Milkman', 'Affiliation': 'Operations, Information and Decisions Department, The Wharton School of the University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9863']
2515,32441709,Evaluation of the effect of endoscopic partial middleturbinectomy surgery on the quality of life of patients with chronic rhinosinusitis and nasal polyps.,"BACKGROUND
Chronic rhinosinusitis (CRS) is a common chronic inflammatory disease. Endoscopic sinus surgery is recommended as a standard method when medical treatment fails. The effectiveness of various complementary surgical methods such as endoscopic partial middle-turbinectomy is controversial in the improvement of CRS symptoms in these patients. This study aimed to investigate the effect of endoscopic partial middle-turbinectomy on the quality of life (QOL) of patients with chronic rhinosinusitis and nasal polyps (CRSwNP) in Iran.
METHOD
Ninety patients with CRSwNP of grades 3 and 4 were randomly assigned to either an intervention (45 patients) or control group (45 patients). In the control group, endoscopic sinus surgery without middle turbinectomy was performed and in the intervention group, endoscopic partial middle-turbinectomy was performed in addition to endoscopic sinus surgery. To evaluate the outcomes, the SNOT-22 QOL questionnaire was used, and the results were analyzed using SPSS version 24.
RESULTS
Most of the patients were male and had a mean age of 39 years. The mean SNOT-22 QOL questionnaire scores were 49.13 ± 16.72 and 52.51 ± 16.95 before surgery in the control and intervention groups respectively, which did not show any significant difference. In contrast, after endoscopic surgery these scores changed to 28.46 ± 12.38 and 11.13 ± 5.55 in the control and intervention groups, respectively and there was a significant difference between both groups. Although there was a significant improvement in both groups, the patients in the intervention group experienced more improvement than the control group (41.4 (± 16.46)) vs 30.7 (±18.27), respectively CONCLUSION: According to this study, it appears that the use of endoscopic partial middle-turbinectomy in addition to endoscopic sinus surgery improves CRS symptoms and the QOL of patients compared with endoscopic sinus surgery alone.",2020,"Although there was a significant improvement in both groups, the patients in the intervention group experienced more improvement than the control group (41.4 (±16.46) vs 30.7 (±18.27), respectively CONCLUSION:","['patients with chronic rhinosinusitis and nasal polyps (CRSwNP) in Iran', 'patients were male and had a mean age of 39 years', 'patients with chronic rhinosinusitis and nasal polyps', 'Chronic rhinosinusitis (CRS', 'Ninety patients with CRSwNP of grades 3 and 4']","['endoscopic partial middleturbinectomy surgery', 'endoscopic partial middle-turbinectomy was performed in addition to endoscopic sinus surgery', 'Endoscopic sinus surgery', 'endoscopic partial middle-turbinectomy', 'endoscopic sinus surgery without middle turbinectomy']","['quality of life', 'mean SNOT-22 QOL questionnaire scores', 'quality of life (QOL', 'SNOT-22 QOL questionnaire', 'CRS symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0161872', 'cui_str': 'Turbinectomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",90.0,0.0323866,"Although there was a significant improvement in both groups, the patients in the intervention group experienced more improvement than the control group (41.4 (±16.46) vs 30.7 (±18.27), respectively CONCLUSION:","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Delarestaghi', 'Affiliation': 'Firoozgar Clinical Research Development Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rajaeih', 'Affiliation': 'Firoozgar Clinical Research Development Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Firouzabadi', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jamali', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roomiani', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Firouzabadi', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Memari', 'Affiliation': 'Firoozgar Clinical Research Development Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jahandideh', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}]",Rhinology,['10.4193/Rhin19.258']
2516,32011015,"Long-term clinical and radiographic results after treatment or no treatment of small buccal bone dehiscences at posterior dental implants: A randomized, controlled clinical trial.","AIM
To test whether or not buccal vertical bone dehiscences (≤5 mm) around posterior implants left for spontaneous healing (SH) result in the same clinical and radiologic outcome as dehiscences treated with guided bone regeneration (GBR) at 7.5 years after implant placement (IMPL).
MATERIALS AND METHODS
Twenty-two patients receiving 28 posterior implants with a small non-contained buccal bone dehiscence (≤5 mm) were randomly assigned to the SH or the GBR group. Implants were loaded at 6 months. Clinical parameters (probing depths, sulcus bleeding index, plaque index) and approximal marginal radiographic bone levels were assessed regularly up to at least 6.8 years. The vertical extension of the dehiscences was measured clinically at IMPL and abutment connection and radiographically on cone beam computed tomographys at a mean follow-up time of 7.5 years.
RESULTS
Twenty patients with a total of 26 implants were recalled at 7.5 years (9.1% dropout). The implant/crown survival rates were 100% in both groups. Stable peri-implant tissues were observed in both groups showing only minimal signs of inflammation. During the entire study period (IMPL-7.5-year follow-up), the median buccal vertical bone gain measured 1.61 mm for the GBR group and 0.62 for the SH group showing no significant difference between the groups. Also, at 7.5 years, the median approximal marginal bone levels (GBR: 0.53; SH: 0.68) were not significantly different between the two groups (p = .61) while the remaining median buccal vertical dehiscences were larger in the SH group (2.51 mm) compared to the GBR group (1.66 mm; p = .02).
CONCLUSIONS
Implants with small non-contained buccal bone dehiscences exhibited high implant survival rates and healthy peri-implant tissues at 7.5 years. In the GBR group, the buccal vertical bone levels were higher compared to the SH group but remained stable over the entire study period for both treatments.",2020,"In the GBR group, the buccal vertical bone levels were higher compared to the SH group but remained stable over the entire study period for both treatments.","['small buccal bone dehiscences at posterior dental implants', '22 patients receiving 28 posterior implants with a small non-contained buccal bone dehiscence (≤5 mm', '20 patients with a total of 26 implants were recalled at 7.5 years (9.1% drop-out']","['guided bone regeneration (GBR', 'buccal vertical bone dehiscences (≤5 mm) around posterior implants left']","['buccal vertical bone levels', 'implant/crown survival rates', 'spontaneous healing (SH', 'median buccal vertical bone gain', 'implant survival rates', 'median buccal vertical dehiscences', 'median approximal marginal bone levels', 'Clinical parameters (PD, SBI, PI) and approximal marginal radiographic bone levels']","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0011373', 'cui_str': 'Dental Implants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]",26.0,0.0310598,"In the GBR group, the buccal vertical bone levels were higher compared to the SH group but remained stable over the entire study period for both treatments.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Waller', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Herzog', 'Affiliation': 'Private Practice, Affoltern a.A., Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Thoma', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Hüsler', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph H F', 'Initials': 'CHF', 'LastName': 'Hämmerle', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}]",Clinical oral implants research,['10.1111/clr.13588']
2517,32495016,Postoperative comparison of laparoscopic radical resection and open abdominal radical hysterectomy for cervical cancer patient.,"PURPOSE
There are limited data regarding postoperative complications and autoimmune reactions caused by surgery in early-stage cervical cancer patients who underwent laparoscopic radical resection (LRR). This study aimed to investigate the therapeutic effect of LRR of cervical cancer patients and its effect on cytokines.
METHODS
168 patients with cervical cancer were enrolled. The patients were divided into open group and laparoscopic group according to the random number table method, with 84 cases in each group. The surgical-related indexes and the incidence of complications of the two groups were observed, and the IFN-γ, TNF, and IL-1/2/4/6/8/10/12 levels in peripheral blood were compared before and after surgery in both groups.
RESULTS
The operation time of the patients in the laparoscopic group was significantly shorter than that in the open group (119.56 ± 45.26 vs. 206.36 ± 54.39, P < 0.01). The intraoperative blood loss in the laparoscopic group was significantly less than that in the open group (155.29 ± 57.58 vs. 529.58 ± 162.4, P < 0.01). The postoperative visual analog scale (VAS) score was also significantly lower than that in the open group (3.65 ± 0.88 vs. 6.32 ± 1.12, P < 0.01). There was no significant difference in the incidence of complications between the two groups. The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001).
CONCLUSIONS
LRR surgery has less stress on patients with early cervical cancer than open surgery within 5 days after surgery, which has certain reference value for early cervical cancer treatment.",2020,"The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001).
","['168 patients with cervical cancer were enrolled', 'early-stage cervical cancer patients who underwent', 'cervical cancer patient', 'cervical cancer patients', 'patients with early cervical cancer']","['laparoscopic radical resection and open abdominal radical hysterectomy', 'laparoscopic', 'laparoscopic radical resection (LRR', 'LRR surgery']","['IFN-γ, TNF, and IL-1/2/4/6/8/10/12 levels in peripheral blood', 'degree of inflammatory cytokines changes', 'postoperative visual analog scale (VAS) score', 'intraoperative blood loss', 'incidence of complications', 'operation time']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",168.0,0.0199014,"The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001).
","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Dehong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China. yinianwuji212@163.com.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China. hcfy98@126.com.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05606-2']
2518,32495114,Effects of Continuous Theta Burst Stimulation Over the Left Dlpfc on Mother Tongue and Second Language Production In Late Bilinguals: A Behavioral and ERP Study.,"Clinical, neuroimaging, and non-invasive brain stimulation studies have associated the dorsolateral prefrontal cortex (DLPFC) with the multilingual language control system. Here, we investigated if this role is increased during the processing of the non-dominant language due to the higher cognitive/attentional demands. We used an inhibitory repetitive transcranial magnetic stimulation (rTMS) protocol over the left DLPFC and investigated the behavioral and electrophysiological effects on (i) picture naming in the mother tongue and second language, (ii) forward and backward translation and (iii) non-verbal inhibition. To this end, we compared the effects of inhibitory rTMS (cTBS) vs sham-rTMS using a single-blind within-subject design including 22 late bilinguals. Behaviorally, response times were longer after cTBS compared to sham-rTMS in the picture naming task independent of language, while response times were not affected for the word translation task. These results were mirrored on the electrophysiological level showing an effect of stimulation in the picture naming task starting at 547 ms post-stimulus onset, but not in the translation task. This late time range is likely associated with processes of conflict resolution and initiation of the articulation of the word rather than processes related to lexical selection or language switching. For the non-verbal inhibition task, behavioral outcome was not affected despite electrophysiological stimulation-induced changes. Overall, the results suggest that the DLPFC plays a role in top-down cognitive control in language production, but that this role is not increased with higher cognitive demand such as naming in a second language or in language switching during word translation.",2020,"Behaviorally, response times were longer after cTBS compared to sham-rTMS in the picture naming task independent of language, while response times were not affected for the word translation task.",['In Late Bilinguals'],"['inhibitory rTMS (cTBS) vs sham-rTMS', 'inhibitory repetitive transcranial magnetic stimulation (rTMS) protocol', 'Continuous Theta Burst Stimulation']","['behavioral and electrophysiological effects on (i) picture naming in the mother tongue and second language, (ii) forward and backward translation and (iii) non-verbal inhibition', 'Mother Tongue and Second Language Production']","[{'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0557072', 'cui_str': 'Mother tongue'}, {'cui': 'C0557074', 'cui_str': 'Second language'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.033267,"Behaviorally, response times were longer after cTBS compared to sham-rTMS in the picture naming task independent of language, while response times were not affected for the word translation task.","[{'ForeName': 'Lea B', 'Initials': 'LB', 'LastName': 'Jost', 'Affiliation': 'Laboratory for Cognitive and Neurological Sciences, Neurology Unit, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, Ch. du Musée 5, CH-1700, Fribourg, Switzerland. lea.jost@unifr.ch.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Pestalozzi', 'Affiliation': 'Laboratory for Cognitive and Neurological Sciences, Neurology Unit, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, Ch. du Musée 5, CH-1700, Fribourg, Switzerland.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cazzoli', 'Affiliation': 'Gerontechnology and Rehabilitation Group, ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mouthon', 'Affiliation': 'Laboratory for Cognitive and Neurological Sciences, Neurology Unit, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, Ch. du Musée 5, CH-1700, Fribourg, Switzerland.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Müri', 'Affiliation': 'Gerontechnology and Rehabilitation Group, ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Annoni', 'Affiliation': 'Laboratory for Cognitive and Neurological Sciences, Neurology Unit, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, Ch. du Musée 5, CH-1700, Fribourg, Switzerland.'}]",Brain topography,['10.1007/s10548-020-00779-0']
2519,32437393,"Fecal microbiota transplantation in systemic sclerosis: A double-blind, placebo-controlled randomized pilot trial.","OBJECTIVES
Systemic sclerosis (SSc) is an auto-immune, multi organ disease marked by severe gastrointestinal (GI) involvement and gut dysbiosis. Here, we aimed to determine the safety and efficacy of fecal microbiota transplantation (FMT) using commercially-available anaerobic cultivated human intestinal microbiota (ACHIM) in SSc.
METHODS
Ten patients with SSc were randomized to ACHIM (n = 5) or placebo (n = 5) in a double-blind, placebo-controlled 16-week pilot. All patients had mild to severe upper and lower GI symptoms including diarrhea, distention/bloating and/or fecal incontinence at baseline. Gastroduodenoscopy transfer of ACHIM or placebo was performed at weeks 0 and 2. Primary endpoints were safety and clinical efficacy on GI symptoms assessed at weeks 4 and 16. Secondary endpoints included changes in relative abundance of total, immunoglobulin (Ig) A- and IgM-coated fecal bacteria measured by 16s rRNA sequencing.
RESULTS
ACHIM side effects were mild and transient. Two placebo controls experienced procedure-related serious adverse events; one developed laryngospasms at week 0 gastroduodenoscopy necessitating study exclusion whilst one encountered duodenal perforation during gastroduodenoscopy at the last study visit (week 16). Decreased bloating, diarrhea and/or fecal incontinence was observed in four of five patients in the FMT group (week 4 or/and 16) and in two of four in the placebo group (week 4 or 16). Relative abundance, richness and diversity of total and IgA-coated and IgM-coated bacteria fluctuated more after FMT, than after placebo.
CONCLUSIONS
FMT of commercially-available ACHIM is associated with gastroduodenoscopy complications but reduces lower GI symptoms by possibly altering the gut microbiota in patients with SSc.",2020,"Relative abundance, richness and diversity of total and IgA-coated and IgM-coated bacteria fluctuated more after FMT, than after placebo.
","['Ten patients with SSc', 'systemic sclerosis', 'patients with SSc']","['fecal microbiota transplantation (FMT', 'FMT', 'ACHIM or placebo', 'ACHIM', 'Fecal microbiota transplantation', 'placebo']","['safety and clinical efficacy on GI symptoms', 'changes in relative abundance of total, immunoglobulin (Ig) A- and IgM-coated fecal bacteria measured by 16s rRNA sequencing', 'procedure-related serious adverse events', 'mild to severe upper and lower GI symptoms including diarrhea, distention/bloating and/or fecal incontinence', 'Decreased bloating, diarrhea and/or fecal incontinence', 'Relative abundance, richness and diversity of total and IgA-coated and IgM-coated bacteria fluctuated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231241', 'cui_str': 'Fluctuating'}]",10.0,0.365308,"Relative abundance, richness and diversity of total and IgA-coated and IgM-coated bacteria fluctuated more after FMT, than after placebo.
","[{'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Fretheim', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Chung', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Didriksen', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Espen S', 'Initials': 'ES', 'LastName': 'Bækkevold', 'Affiliation': 'Department of Pathology and Centre for Immune Regulation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Midtvedt', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Brunborg', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Holm', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Unger-Vetlesen Institute, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'Anders Heiervang', 'Initials': 'AH', 'LastName': 'Tennøe', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Torhild', 'Initials': 'T', 'LastName': 'Garen', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Midtvedt', 'Affiliation': 'Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Trøseid', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Hasse', 'Initials': 'H', 'LastName': 'Zarè', 'Affiliation': 'Clinical Trial Unit, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'May Brit', 'Initials': 'MB', 'LastName': 'Lund', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Hov', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Knut E A', 'Initials': 'KEA', 'LastName': 'Lundin', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Molberg', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Hoffmann-Vold', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}]",PloS one,['10.1371/journal.pone.0232739']
2520,31433518,Zoledronate for the Prevention of Bone Loss in Women Discontinuing Denosumab Treatment. A Prospective 2-Year Clinical Trial.,"Cessation of denosumab treatment is associated with increases in bone turnover above baseline values and rapid bone loss. We investigated the efficacy of zoledronate to prevent this bone loss in women with postmenopausal osteoporosis who were treated with denosumab (mean duration 2.2 years) and discontinued treatment after achieving osteopenia. Women were randomized to receive a single 5-mg infusion of zoledronate (ZOL) (n = 27) or two additional 60-mg injections of denosumab (Dmab) (n = 30). Both groups were followed for a total period of 24 months. At 24 months lumbar spine-bone mineral density (LS-BMD) was not different from baseline in the ZOL group, but decreased in the Dmab group by (mean ± SD) 4.82% ± 0.7% (p < 0.001) from the 12-month value; the difference in BMD changes between the two groups, the primary endpoint of the study, was statistically significant (p = 0.025). Results of femoral neck (FN)-BMD changes were similar. ZOL infusion was followed by small but significant increases in serum procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide of type 1 collagen (CTX) during the first year and stabilization thereafter. In the Dmab group, bone turnover marker values did not change during the first 12 months but increased significantly at 15 months and in the majority of women these remained elevated at 24 months. Neither baseline nor 12-month bone turnover marker values were associated with BMD changes in either group of women. In the Dmab group, three patients sustained vertebral fractures (two patients multiple clinical, one patient morphometric) whereas one patient in the ZOL group sustained clinical vertebral fractures 12 months after the infusion. In conclusion, a single intravenous infusion of ZOL given 6 months after the last Dmab injection prevents bone loss for at least 2 years independently of the rate of bone turnover. Follow-up is recommended, because in a few patients ZOL treatment might not have the expected effect at 2 years. © 2019 American Society for Bone and Mineral Research.",2019,"At 24 months LS-BMD was not different from baseline in the ZOL group, but decreased in the Dmab group by 4.82 ± 0.7% (p < 0.001) from the 12-month value; the difference in BMD changes between the two groups, the primary endpoint of the study, was statistically significant (p = 0.025).","['Women Discontinuing Denosumab Treatment', 'women with postmenopausal osteoporosis who were treated with denosumab (mean duration 2.2\u2009years) and discontinued treatment after achieving osteopenia']","['denosumab', 'zoledronate', 'single zoledronate 5\u2009mg infusion (n\xa0=\xa027) or two additional denosumab 60\u2009mg injections', 'Zoledronate']","['serum Procollagen type 1\u2009N-terminal propeptide (P1NP) and C-terminal telopeptide of type 1 collagen (CTX', 'bone turnover marker values', 'Bone Loss', '12-month bone turnover marker values', 'BMD changes', 'vertebral fractures', 'bone loss', 'bone turnover above baseline values and rapid bone loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",,0.0319117,"At 24 months LS-BMD was not different from baseline in the ZOL group, but decreased in the Dmab group by 4.82 ± 0.7% (p < 0.001) from the 12-month value; the difference in BMD changes between the two groups, the primary endpoint of the study, was statistically significant (p = 0.025).","[{'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Anastasilakis', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Department of Pharmacology, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3853']
2521,31209171,Training on Abacus-Based Mental Calculation Enhances Visuospatial Working Memory in Children.,"Abacus-based mental calculation (AMC) involves temporary storage and manipulation of an imaginary abacus closely related to the function of visuospatial working memory (VSWM). The present study thus investigated the effects of AMC training on VSWM and its neural correlates. A total of 144 human subjects (67 boys) were assigned to AMC or control groups at their entry to primary school. The AMC group received 2 h AMC training per week for 5 school years, whereas the control group spent the time in activities, such as conventional calculation and reading. Raven's Intelligence Test was administered both before and after training. Two arithmetic tests and a VSWM task were conducted after training. Among these participants, fMRI data were collected from 64 children for the VSWM task. Behavioral results indicated that the AMC group outperformed controls on both arithmetic and VSWM tasks, but not on Raven's Intelligence Test. While the two groups activated similar regions during the VSWM task, the AMC group showed greater activation than the controls in frontal, parietal, and occipital areas. Interestingly, the activation of right middle frontal gyrus mediated the relation between the arithmetic ability and the VSWM performance in the AMC group, suggesting that the frontal region may be the neural substrate underlying the transfer effect from AMC training to VSWM. Although the transfer effects seem quite limited considering the length and intensity of the training, these findings suggest that long-term AMC training not only improves arithmetic ability but also has a potential positive effect on VSWM. SIGNIFICANCE STATEMENT Plasticity of working memory is one of the most rapidly expanding research fields in the developmental and cognitive sciences. Previous studies suggest that abacus-based mental calculation (AMC) relies on a visuospatial imaginary strategy, which is closely related to visuospatial working memory (VSWM). However, the impacts of AMC training on VSWM and the underlying neural basis remain unclear. Here, we found that AMC training enhanced VSWM in children, which was accompanied by altered activation in frontal, parietal, and occipital areas. Moreover, we observed that activation in right middle frontal gyrus played a significant mediation role in the transfer of AMC training to VSWM. These findings provide a new perspective to VSWM training and also advance our understanding of related brain plasticity.",2019,"While the two groups activated similar regions during the VSWM task, the AMC group showed greater activation than the controls in frontal, parietal and occipital areas.","['children', 'One hundred and forty-four human subjects (67 boys']","['AMC', 'Abacus-based mental calculation (AMC', '2-hour AMC training', 'AMC training']","[""Raven's intelligence test"", 'arithmetic and VSWM tasks', 'VSWM performance', 'arithmetic ability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0382121', 'cui_str': '(3H)-AMC'}, {'cui': 'C3878323', 'cui_str': 'Abacus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1449597', 'cui_str': 'Ravens'}, {'cui': 'C0021705', 'cui_str': 'Intelligence Tests'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",144.0,0.0146081,"While the two groups activated similar regions during the VSWM task, the AMC group showed greater activation than the controls in frontal, parietal and occipital areas.","[{'ForeName': 'Chunjie', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou 310027, China.'}, {'ForeName': 'Tianyong', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou 310027, China.'}, {'ForeName': 'Fengji', 'Initials': 'F', 'LastName': 'Geng', 'Affiliation': 'Department of Curriculum and Learning Sciences, College of Education, Zhejiang University, Hangzhou 310027, China.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310027, China, and huyuzheng@zju.edu.cn chenfy@zju.edu.cn.'}, {'ForeName': 'Yunqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of International Studies, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Huafeng', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Modern Optical Instrumentation, Department of Optical Engineering, Zhejiang University, Hangzhou 310027, China.'}, {'ForeName': 'Feiyan', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou 310027, China, huyuzheng@zju.edu.cn chenfy@zju.edu.cn.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.3195-18.2019']
2522,32495208,Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion.,"STUDY DESIGN
Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves.
OBJECTIVE
We hypothesized that patients and families considering fusion surgery would be willing to enroll in a randomized controlled trial (RCT) evaluating the effect of number of implants on curve correction. Surgical RCTs are infrequently performed, particularly in a pediatric population. Parental willingness to enroll affects both study design and trial feasibility. The Minimize Implants Maximize Outcomes (MIMO) Clinical Trial proposes to randomize patients to more versus fewer screws (high or low density) for Lenke 1A curve patterns, but it is unclear whether families and patients are willing to enroll in such a trial.
METHODS
This study was undertaken at 4 of the 14 sites participating in the MIMO Clinical Trial. AIS patients with Cobb > 45° were included. Implant density is defined as screws per level fused. Patients and families reviewed the MIMO education module describing proposed advantages and disadvantages of high (> 1.8) vs. low (< 1.4) density screw constructs and completed a custom survey regarding their preferences about the trial.
RESULTS
159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients. Of those surveyed, 95% mostly or completely understood the trial (range 47-78%), and 63% agreed to enroll. Parents and patients who completely understood the trial were significantly more likely to enroll.
CONCLUSION
Randomization in the MIMO Trial was acceptable to the majority (63%) of patients and parents. Clear patient and parent education materials and access to the surgeon may facilitate enrollment in the trial. Parents afforded the child much autonomy when considering enrollment, although most families agree both child and parent should be in agreement before entering the trial.
LEVEL OF EVIDENCE
II.",2020,"Parents and patients who completely understood the trial were significantly more likely to enroll.
","['adolescent idiopathic scoliosis fusion', '14 sites participating in the MIMO Clinical Trial', 'adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves', 'patients and families considering fusion surgery', '159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients', 'AIS patients with Cobb\u2009>\u200945° were included']",[],"['Minimize Implants Maximize Outcomes (MIMO', 'Implant density']","[{'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}]",[],"[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",159.0,0.204835,"Parents and patients who completely understood the trial were significantly more likely to enroll.
","[{'ForeName': 'A Noelle', 'Initials': 'AN', 'LastName': 'Larson', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. larson.noelle@mayo.edu.'}, {'ForeName': 'Lorena V', 'Initials': 'LV', 'LastName': 'Floccari', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Erickson', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sponseller', 'Affiliation': 'Johns Hopkin University, Baltimore, MD, USA.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Mayo Clinic Shared Decision Making National Resource Center, Mayo Clinic, Rochester, USA.'}, {'ForeName': 'Carl-Eric', 'Initials': 'CE', 'LastName': 'Aubin', 'Affiliation': 'Polytechnique Montreal, Montreal, QC, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Polly', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Spine deformity,['10.1007/s43390-020-00143-z']
2523,31432311,Anti-infective therapy of peri-implant mucositis with adjunctive delivery of a sodium hypochlorite gel: a 6-month randomized triple-blind controlled clinical trial.,"OBJECTIVE
To evaluate the effects of adjunctive delivery of a sodium hypochlorite gel in the treatment of peri-implant mucositis (PM).
MATERIALS AND METHODS
Forty-six subjects with 68 implants diagnosed with PM were randomly assigned to two treatment groups. Prior to mechanical debridement, a sodium hypochlorite gel was delivered to the implants of the test group while implants of the control group received a placebo gel. Application of both test and placebo gels was repeated 5 times at baseline. The primary outcome variable was the change in pocket probing depth (PPD) between baseline and 6 months.
RESULTS
After 6 months, the mean PPD decreased statistically significantly from 3.93 ± 1.09 mm to 3.04 ± 0.46 mm in the test (p = 0.0001) and from 3.68 ± 0.85 mm to 3.07 ± 0.58 mm in the control (p = 0.0001) group, respectively. No statistically significant difference (p = 0.53) was observed with respect to PPD changes from baseline to 6 months between test (0.88 ± 1.04 mm) and control group (0.61 ± 0.75 mm), respectively. The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.
CONCLUSIONS
In conclusion and within the limits of the present study, changes in PPD from baseline to 6 months were not statistically significantly different between groups. Complete resolution of mucosal inflammation was not achieved with either of the therapies.
CLINICAL RELEVANCE
The present outcomes have showed that a complete resolution of peri-implant mucositis is not possible to obtain by means mechanical debridement with or without a sodium hypochlorite gel application.",2020,"The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.
","['peri-implant mucositis (PM', 'Forty-six subjects with 68 implants diagnosed with PM']","['placebo', 'placebo gel', 'sodium hypochlorite gel']","['mean PPD', 'PPD changes', 'Complete resolution of mucosal inflammation', 'change in pocket probing depth (PPD', 'number of implants with bleeding on probing (BoP']","[{'cui': 'C3698407', 'cui_str': 'Dental peri-implant mucositis (disorder)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}]",46.0,0.138324,"The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.
","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iorio-Siciliano', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy. enzois@libero.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Blasi', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy.'}, {'ForeName': 'Stefan-Ioan', 'Initials': 'SI', 'LastName': 'Stratul', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramaglia', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse, 7CH-3010, Bern, Switzerland.'}, {'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Salvi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse, 7CH-3010, Bern, Switzerland.'}, {'ForeName': 'Darian', 'Initials': 'D', 'LastName': 'Rusu', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}]",Clinical oral investigations,['10.1007/s00784-019-03060-2']
2524,31429912,Comparing Web-Based and Classroom-Based Memory Training for Older Adults: The ACTIVE Memory Works™ Study.,"OBJECTIVES
To compare the efficacy of a web-based versus a classroom-based memory training program in enhancing cognition and everyday functioning in older adults, and program satisfaction and acceptability.
METHOD
Participants (N = 208; mean age = 71.1) were randomly assigned to a web-based or classroom-based training, or to a wait-list control condition. Cognitive and everyday functioning measures were administered at baseline, immediate, and 6 months post-training; both training groups evaluated program satisfaction and acceptability at immediate post-training. Repeated-measures analyses of variance assessed training effects on cognitive and functioning outcomes; independent-samples t tests assessed group differences in program satisfaction and acceptability.
RESULTS
Compared to controls, neither training group showed a significant improvement on measures of memory or everyday functioning as assessed by dependence or difficulty on instrumental activities of daily living over time. Training effects did not transfer to non-trained cognitive abilities. The web-based group was as satisfied with the training as the classroom-based group (p > .05).
DISCUSSION
Although no significant training effects were found, we demonstrated that a web-based platform is an acceptable and feasible mode to provide memory training to healthy older adults. Further studies are needed to investigate the potential of web-based memory training programs for improving cognition and function in cognitively healthy older adults.",2020,"The web-based group was as satisfied with the training as the classroom-based group (p>.05).
","['healthy older adults', 'Older Adults', 'older adults', 'Participants (N=208', 'cognitively healthy older adults']","['web-based versus a classroom-based memory training program', 'web-based or classroom-based training, or to a wait-list control condition', 'Web-based and Classroom-based Memory Training']","['transfer to non-trained cognitive abilities', 'Cognitive and everyday functioning measures', 'instrumental activities of daily living over time', 'program satisfaction and acceptability', 'measures of memory or everyday functioning']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729377', 'cui_str': 'Memory Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0183112,"The web-based group was as satisfied with the training as the classroom-based group (p>.05).
","[{'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Tzuang', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Jeanine M', 'Initials': 'JM', 'LastName': 'Parisi', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz107']
2525,32437703,"Reactions to graphic and text health warnings for cigarettes, sugar-sweetened beverages, and alcohol: An online randomized experiment of US adults.","We aimed to examine reactions to graphic versus text-only warnings for cigarettes, SSBs, and alcohol. A convenience sample of US adults completed an online survey in 2018 (n = 1352 in the analytic sample). We randomly assigned participants to view a: 1) text-only warning without efficacy information (i.e., message intended to increase consumers' confidence in their ability to stop using the product), 2) text-only warning with efficacy information, 3) graphic warning without efficacy information, or 4) graphic warning with efficacy information. Participants viewed their assigned warning on cigarettes, SSBs, and alcohol, in a random order. Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ. Compared to SSB and alcohol warnings, cigarette warnings led to higher perceived message effectiveness, believability, fear, thinking about harms, policy support, and greater reductions in product appeal (all p < .05). The efficacy information did not influence any outcomes. Graphic warnings out-performed text-only warnings on key predictors of behavior despite causing more reactance.",2020,"Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ.","['A convenience sample of US adults completed an online survey in 2018 (n\u202f=\u202f1352 in the analytic sample', 'cigarettes, sugar-sweetened beverages, and alcohol', 'US adults']","[""text-only warning without efficacy information (i.e., message intended to increase consumers' confidence in their ability to stop using the product), 2) text-only warning with efficacy information, 3) graphic warning without efficacy information, or 4) graphic warning with efficacy information""]","['message effectiveness, believability, fear, thinking about harms, policy support', 'lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332288', 'cui_str': 'Without'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0359166,"Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ.","[{'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA. Electronic address: mghall@unc.edu.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Center for Population and Development Studies, Harvard TH Chan School of Public Health, Cambridge, MA, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Maynard', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK; MRC Integrative Epidemiology Unit (IEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106120']
2526,32437664,"First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial.","BACKGROUND
Addition of trastuzumab to first-line chemotherapy improves overall survival in patients with HER2-positive metastatic gastric cancer. We assessed the safety and activity of pembrolizumab in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer.
METHODS
This study was an investigator-initiated, open-label, non-randomised, single-arm, single centre, phase 2 trial in patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer. Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53%. Patients were eligible to receive an initial induction cycle of 200 mg flat dose of intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab. For subsequent cycles, patients received 130 mg/m 2 of intravenous oxaliplatin or 80 mg/m 2 of cisplatin on day 1, 850 mg/m 2 of oral capecitabine twice a day for 2 weeks followed by 1 week off (or intravenous 5-fluorouracil, 800 mg/m 2 per day on days 1-5), and a 200 mg flat dose of intravenous pembrolizumab, and 6 mg/kg of trastuzumab, administered on day 1 of each 3-week cycle. The primary endpoint was 6-month progression-free survival, defined as the proportion of patients alive and free of progression at 6 months, assessed in patients who received at least one dose of trastuzumab and pembrolizumab. The regimen would be considered worthy of further investigation if 26 or more of 37 patients were progression-free at 6 months. This trial is registered with ClinicalTrials.gov, NCT02954536, and is ongoing, but closed to enrolment.
FINDINGS
Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled. At the time of data cutoff on Aug 6, 2019, median follow-up among survivors was 13·0 months (IQR 11·7-23·5). The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months. The most common treatment-related adverse event of any grade was neuropathy, which was reported in 36 (97%) of 37 patients. The most common grade 3 or 4 adverse events were lymphocytopenia (seven [19%] patients with grade 3 and two [5%] with grade 4), grade 3 decreased electrolytes (six [16%] patients), and grade 3 anaemia (four [11%] patients). Serious adverse events occurred in two patients patients (both grade 3 nephritis leading to treatment discontinuation). Four patients discontinued pembrolizumab because of immune-related adverse events. There were no treatment-related deaths.
INTERPRETATION
Pembrolizumab can be safely combined with trastuzumab and chemotherapy and has promising activity in HER2-positive metastatic oesophagogastric cancer. A randomised phase 3 clinical trial assessing the efficacy and safety of pembrolizumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric cancer is underway.
FUNDING
Merck & Co.",2020,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"['HER2-positive metastatic oesophagogastric cancer', 'Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53', 'patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer', 'first-line HER2-positive metastatic oesophagogastric cancer', 'HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer', 'Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled', 'first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer', 'patients with HER2-positive metastatic gastric cancer']","['oxaliplatin', 'intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab', 'trastuzumab and pembrolizumab', 'trastuzumab to first-line chemotherapy', 'trastuzumab and chemotherapy', 'capecitabine', 'cisplatin', 'pembrolizumab, and 6 mg/kg of trastuzumab', 'pembrolizumab versus placebo', 'First-line pembrolizumab and trastuzumab', '5-fluorouracil', 'pembrolizumab']","['safety and activity', '6-month progression-free survival, defined as the proportion of patients alive and free of progression', 'overall survival', 'grade 3 decreased electrolytes', 'grade 3 anaemia', 'efficacy and safety', 'Serious adverse events']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0740464', 'cui_str': 'Electrolytes NOS decreased'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",37.0,0.193351,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"[{'ForeName': 'Yelena Y', 'Initials': 'YY', 'LastName': 'Janjigian', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA. Electronic address: janjigiy@mskcc.org.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Maron', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Walid K', 'Initials': 'WK', 'LastName': 'Chatila', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Tri-Institutional Program in Computational Biology and Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Brittanie', 'Initials': 'B', 'LastName': 'Millang', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shweta S', 'Initials': 'SS', 'LastName': 'Chavan', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Alterman', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Segal', 'Affiliation': 'Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marc Z', 'Initials': 'MZ', 'LastName': 'Simmons', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Momtaz', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Shcherba', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Geoffrey Y', 'Initials': 'GY', 'LastName': 'Ku', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Zervoudakis', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Won', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kelsen', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Nagy', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lanman', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Ptashkin', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark T A', 'Initials': 'MTA', 'LastName': 'Donoghue', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Taylor', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Solit', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Schultz', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jaclyn F', 'Initials': 'JF', 'LastName': 'Hechtman', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30169-8']
2527,32073408,Video-assisted cardiopulmonary resuscitation via smartphone improves quality of resuscitation: A randomised controlled simulation trial.,"BACKGROUND
Despite intensive research, cardiac arrest remains a leading cause of death. It is of paramount importance to undertake every possible effort to increase the overall quality of cardiopulmonary resuscitation (CPR) and improve patient outcome. CPR initiated by a bystander is one of the key factors in survival of such an incident. Telephone-assisted CPR (T-CPR) has proved to be an effective measure in improving layperson resuscitation.
OBJECTIVE
We hypothesised that adding video-telephony to the emergency call (video-CPR, V-CPR) enhances the quality of layperson resuscitation.
DESIGN
This randomised controlled simulation trial was performed from July to August 2018. Laypersons were randomly assigned to video-assisted (V-CPR), telephone-assisted (T-CPR) or control (unassisted CPR) groups. Participants were instructed to perform first aid on a mannequin during a simulated cardiac arrest.
SETTING
This study was conducted in the Skills Lab of the University Hospital of Cologne.
PARTICIPANTS
One hundred and fifty healthy adult volunteers.
INTERVENTION
The participants received a smartphone to call emergency services, with Emergency Eye video-call in V-CPR group, and normal telephone functionality in the other groups. T-CPR and V-CPR groups received standardised CPR assistance via phone.
MAIN OUTCOME MEASURES
Our primary endpoint was resuscitation quality, quantified by compression frequency and depth, and correct hand position.
RESULTS
Mean compression frequency of V-CPR group was 106.4 ± 11.7 min, T-CPR group 98.9 ± 12.3 min (NS), unassisted group 71.6 ± 32.3 min (P < 0.001). Mean compression depth was 55.4 ± 12.3 mm in V-CPR, 52.1 ± 13.3 mm in T-CPR (P < 0.001) and 52.9 ± 15.5 mm in unassisted (P < 0.001). Total percentage of correct chest compressions was significantly higher (P < 0.001) in V-CPR (82.6%), than T-CPR (75.4%) and unassisted (77.3%) groups.
CONCLUSION
V-CPR was shown to be superior to unassisted CPR, and was comparable to T-CPR. However, V-CPR leads to a significantly better hand position compared with the other study groups. V-CPR assistance resulted in volunteers performing chest compressions with more accurate compression depth. Despite reaching statistical significance, this may be of little clinical relevance.
TRIAL REGISTRATION
ClinicalTrials.gov (Identifier: NCT03527771).",2020,"Total percentage of correct chest compressions was significantly higher (P < 0.001) in V-CPR (82.6%), than T-CPR (75.4%) and unassisted (77.3%) groups.
","['One hundred and fifty healthy adult volunteers', 'Skills Lab of the University Hospital of Cologne']","['standardised CPR assistance via phone', 'smartphone to call emergency services, with Emergency Eye video-call in V-CPR group, and normal telephone functionality', 'video-assisted (V-CPR), telephone-assisted (T-CPR) or control (unassisted CPR', 'Video-assisted cardiopulmonary resuscitation via smartphone', 'V-CPR assistance', 'video-telephony', 'Telephone-assisted CPR (T-CPR']","['quality of resuscitation', 'overall quality of cardiopulmonary resuscitation (CPR', 'Total percentage of correct chest compressions', 'resuscitation quality, quantified by compression frequency and depth, and correct hand position', 'Mean compression frequency', 'Mean compression depth']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",150.0,0.0961263,"Total percentage of correct chest compressions was significantly higher (P < 0.001) in V-CPR (82.6%), than T-CPR (75.4%) and unassisted (77.3%) groups.
","[{'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Ecker', 'Affiliation': 'From the University of Cologne, Faculty of Medicine and University Hospital of Cologne, Department of Anaesthesiology and Intensive Care Medicine (HE, FL, NA, SW, RS, BWB, WAW); University of Cologne, Faculty of Medicine and University Hospital of Cologne, Institute of Medical Statistics and Computational Biology (IMSB), Cologne, (SH) Germany.'}, {'ForeName': 'Falko', 'Initials': 'F', 'LastName': 'Lindacher', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wingen', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schier', 'Affiliation': ''}, {'ForeName': 'Bernd W', 'Initials': 'BW', 'LastName': 'Böttiger', 'Affiliation': ''}, {'ForeName': 'Wolfgang A', 'Initials': 'WA', 'LastName': 'Wetsch', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001177']
2528,32495449,Randomized Crossover Trial to Compare Abuse Liability of Intravenous Remimazolam Versus Intravenous Midazolam and Placebo in Recreational Central Nervous System Depressant Users.,"Remimazolam (RMZ) is a new and ultra-fast-acting, short-duration intravenous benzodiazepine, a drug class associated with abuse potential. This trial was designed to compare the abuse potential of remimazolam with placebo and midazolam (MDZ), a well-characterized member of the same pharmacological class in healthy, recreational drug users 18-55 years-of-age, who demonstrated good drug tolerance and were able to discriminate between midazolam and placebo. At equipotent intravenous doses selected to produce effects ranging from mild/moderate to relatively strong sedation without loss of consciousness (RMZ: 5, 10 mg versus MDZ: 2.5, 5 mg), peak scores (E max or E min , respectively) for drug liking, good/bad/any effects, and sedation (drowsiness and relaxation) were significantly greater than placebo for both active drugs and were broadly comparable between RMZ and MDZ. In contrast, areas under the effect-time curves (TA_AUE) were notably lower for RMZ versus MDZ, particularly for measures of good and any effects, reflecting the shorter duration of action and consistent with the more rapid observed plasma clearance for RMZ versus MDZ and the lack of an active RMZ metabolite. Scores for willingness to take drug again were also lower for RMZ versus MDZ, but not significantly so. We concluded that the abuse potential of RMZ is comparable to or lower than that of MDZ, a drug known to have a low potential for intravenous abuse.",2020,"Scores for willingness to take drug again were also lower for RMZ versus MDZ, but not significantly so.","['Recreational Central Nervous System Depressant Users', 'healthy, recreational drug users 18-55 years-of-age, who demonstrated good drug tolerance and were able to discriminate between']","['Remimazolam', 'Midazolam and Placebo', 'midazolam and placebo', 'benzodiazepine', 'RMZ', 'Remimazolam (RMZ', 'MDZ', 'remimazolam with placebo and midazolam (MDZ', 'placebo']","['peak scores (E max or E min , respectively) for drug liking, good/bad/any effects, and sedation (drowsiness and relaxation']","[{'cui': 'C0007681', 'cui_str': 'CNS Depressants'}, {'cui': 'C1828298', 'cui_str': 'Recreational drug user'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205235', 'cui_str': 'Discriminate'}]","[{'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",,0.0410927,"Scores for willingness to take drug again were also lower for RMZ versus MDZ, but not significantly so.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schippers', 'Affiliation': 'Paion Deutschland GmbH, Aachen, Germany.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Pesic', 'Affiliation': 'Paion Deutschland GmbH, Aachen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Saunders', 'Affiliation': 'Freelance Consultants.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Borkett', 'Affiliation': 'Freelance Consultants.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Searle', 'Affiliation': 'PRA Health Sciences, Raleigh, North Carolina, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Raleigh, North Carolina, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stoehr', 'Affiliation': 'Paion Deutschland GmbH, Aachen, Germany.'}]",Journal of clinical pharmacology,['10.1002/jcph.1614']
2529,32069472,Efficacy of Magnesium Sulfate Treatment in Children with Acute Asthma.,"OBJECTIVE
Systemic administration of magnesium sulfate (MgSO4) has been proposed as a treatment for pediatric patients with acute asthma. However, previous trials show mixed results and uncertain evidence of benefit. The aim of the study was to ascertain whether intravenous (IV) MgSO4 improves lung function parameters in children with acute asthma.
METHODS
This was a prospective clinical trial. All patients with acute asthma received 40-50 mg/kg or maximum 1,500 mg (>30 kg) of single dose IV MgSO4, administered over 60 min. Spirometry was conducted before and 15 min after MgSO4 infusion.
RESULTS
One hundred and fifteen children aged 6 to 17 years presenting with acute asthma and FEV1 between 40% and 75% of predicted were included. Then, the patients were classified into 2 groups; mild asthma attack (FEV1 ranged from 60% to 75%; n = 50) or moderate asthma attack (FEV1 ranged from 40% to 59%; n = 65). The baseline characteristics were similar in both groups. The mean percent predicted pre and post values for FEV1/FVC ratio (mild group: 82.59 ± 9.46 vs. 85.06 ± 8.95; moderate group: 77.31 ± 11.17 vs. 79.99 ± 11.77), FEV1 (mild group: 67.14 ± 4.99 vs. 72.29 ± 8.05; moderate group: 48.50 ± 6.81 vs. 53.78 ± 9.81), PEF (mild group: 65.49 ± 12.32 vs. 71.37 ± 12.96; moderate group: 47.56 ± 11.78 vs. 51.97 ± 13.98), and FEF25-75 (mild group: 58.20 ± 12.24 vs. 66.57 ± 16.95; moderate group: 37.77 ± 11.37 vs. 43.41 ± 14.19) showed a statistically significant (p < 0.05 for all) bronchodilator effect after MgSO4 infusion in both groups with few side effects.
CONCLUSION
Administration of IV MgSO4 was associated with improved pulmonary function in children with acute asthma.",2020,"The mean percent predicted pre and post values for FEV1/FVC ratio (mild group:82,59± 9,46 vs 85,06± 8,95; moderate group:77,31± 11,17 vs 79,99± 11,77),","['children with acute asthma', 'fifteen children aged 6 to 17 years presenting with acute asthma and FEV1 between 40% to 75% of predicted were included', 'patients were classified into 2 groups; mild asthma attack (FEV1 ranged 60% to 75%; n=50) or moderate asthma attack (FEV1 ranged 40% to 59%; n=65', 'All patients with acute asthma', 'One hundred', 'pediatric patients with acute asthma']","['IV MgSO4', 'SULPHATE', 'intravenous (IV) MgSO4', 'magnesium sulphate (MgSO4']","['pulmonary function', 'lung function measurements']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0582415', 'cui_str': 'Acute asthma (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",115.0,0.416135,"The mean percent predicted pre and post values for FEV1/FVC ratio (mild group:82,59± 9,46 vs 85,06± 8,95; moderate group:77,31± 11,17 vs 79,99± 11,77),","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Özdemir', 'Affiliation': 'Pediatric Pulmonary Section, Department of Pediatrics, Mersin City Training and Research Hospital, Mersin, Turkey, aliozdemir@hotmail.com.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Doğruel', 'Affiliation': 'Pediatric Allergy Section, Department of Pediatrics, University of Cukurova, Adana, Turkey.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000506595']
2530,30337060,"Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial.","BACKGROUND
The extent of lymph node dissection (LND) in bladder cancer (BCa) patients at the time of radical cystectomy may affect oncologic outcome.
OBJECTIVE
To evaluate whether extended versus limited LND prolongs recurrence-free survival (RFS).
DESIGN, SETTING, AND PARTICIPANTS
Prospective, multicenter, phase-III trial patients with locally resectable T1G3 or muscle-invasive urothelial BCa (T2-T4aM0).
INTERVENTION
Randomization to limited (obturator, and internal and external iliac nodes) versus extended LND (in addition, deep obturator, common iliac, presacral, paracaval, interaortocaval, and para-aortal nodes up to the inferior mesenteric artery).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary endpoint was RFS. Secondary endpoints included cancer-specific survival (CSS), overall survival (OS), and complications. The trial was designed to show 15% advantage of 5-yr RFS by extended LND.
RESULTS AND LIMITATIONS
In total, 401 patients were randomized from February 2006 to August 2010 (203 limited, 198 extended). The median number of dissected nodes was 19 in the limited and 31 in the extended arm. Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR]=0.84 [95% confidence interval 0.58-1.22]; p=0.36), CSS (5-yr CSS 76% vs 65%; HR=0.70; p=0.10), and OS (5-yr OS 59% vs 50%; HR=0.78; p=0.12). Clavien grade ≥3 lymphoceles were more frequently reported in the extended LND group within 90d after surgery. Inclusion of T1G3 tumors may have contributed to the negative study result.
CONCLUSIONS
Extended LND failed to show a significant advantage over limited LND in RFS, CSS, and OS. A larger trial is required to determine whether extended compared with limited LND leads to a small, but clinically relevant, survival difference (ClinicalTrials.gov NCT01215071).
PATIENT SUMMARY
In this study, we investigated the outcome in bladder cancer patients undergoing cystectomy based on the anatomic extent of lymph node resection. We found that extended removal of lymph nodes did not reduce the rate of tumor recurrence in the expected range.",2019,"Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR]=0.84 [95% confidence interval 0.58-1.22]; p=0.36), CSS (5-yr CSS 76% vs 65%; HR=0.70; p=0.10), and OS (5-yr OS 59% vs 50%; HR=0.78; p=0.12).","['Bladder Cancer Patients', '401 patients were randomized from February 2006 to August 2010 (203 limited, 198 extended', 'bladder cancer (BCa) patients', 'Prospective, multicenter, phase-III trial patients with locally resectable T1G3 or muscle-invasive urothelial BCa (T2-T4aM0', 'bladder cancer patients undergoing cystectomy based on the anatomic extent of lymph node resection']","['Radical Cystectomy', 'Randomization to limited (obturator, and internal and external iliac nodes) versus extended LND']","['median number of dissected nodes', 'RFS', 'Clavien grade ≥3 lymphoceles', 'cancer-specific survival (CSS), overall survival (OS), and complications', 'rate of tumor recurrence']","[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0182021', 'cui_str': 'Obturator (physical object)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0229815', 'cui_str': 'Structure of external iliac lymph node'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205239', 'cui_str': 'Dissecting (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0024248', 'cui_str': 'Lymphatic Cyst'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",401.0,0.430029,"Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR]=0.84 [95% confidence interval 0.58-1.22]; p=0.36), CSS (5-yr CSS 76% vs 65%; HR=0.70; p=0.10), and OS (5-yr OS 59% vs 50%; HR=0.78; p=0.12).","[{'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany. Electronic address: juergen.gschwend@tum.de.'}, {'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Heck', 'Affiliation': 'Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lehmann', 'Affiliation': 'AUO Study Group, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Rübben', 'Affiliation': 'Department of Urology, University of Essen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Albers', 'Affiliation': 'Department of Urology, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Johannes M', 'Initials': 'JM', 'LastName': 'Wolff', 'Affiliation': 'Department of Urology, Paracelsus Hospital Golzheim Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Frohneberg', 'Affiliation': 'Department of Urology, Hospital of Karlsruhe, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'de Geeter', 'Affiliation': 'Department of Urology, Hospital of Kassel, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heidenreich', 'Affiliation': 'Department of Urology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Kälble', 'Affiliation': 'Department of Urology, Hospital of Fulda, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stöckle', 'Affiliation': 'Department of Urology, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schnöller', 'Affiliation': 'Department of Urology, Ulm University, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': 'Department of Urology, Hospital Ludwigshafen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Truss', 'Affiliation': 'Department of Urology, Hospital Dortmund, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Roth', 'Affiliation': 'Department of Urology, Helios Hospital, Wuppertal, Germany.'}, {'ForeName': 'Uwe-Bernd', 'Initials': 'UB', 'LastName': 'Liehr', 'Affiliation': 'Department of Urology, Otto von Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Leißner', 'Affiliation': 'Department of Urology, Hospital Holweide, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bregenzer', 'Affiliation': 'AUO Study Group, Germany.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Retz', 'Affiliation': 'Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.'}]",European urology,['10.1016/j.eururo.2018.09.047']
2531,28799443,Community-Dwelling Older Adults' Adherence to Environmental Fall Prevention Recommendations.,"This study examined the impact of personalized versus generalized education about environmental fall prevention recommendations on older adults' adherence with recommendations. Secondary aims focused on the impact of recent falls and perceived susceptibility of future falls on adherence with recommendations. Twenty-four community-dwelling older adults aged 65 to 89 years were randomized into two groups to receive either personalized or generalized education intervention on environmental fall prevention recommendations. A significant difference was found in the mean total percentage of adherence with recommendations of those receiving personalized education (69%) compared with those receiving generalized education (37%). No statistically significant relationship was found between sustaining recent falls, nor perceived susceptibility to future falls, and their extent of adherence with environmental fall prevention recommendations. Providing personalized education for environmental fall prevention recommendations may improve older adults' adherence with the recommendations given.",2019,A significant difference was found in the mean total percentage of adherence with recommendations of those receiving personalized education (69%) compared with those receiving generalized education (37%).,"[""older adults' adherence with recommendations"", 'Twenty-four community-dwelling older adults aged 65 to 89 years']","['personalized or generalized education intervention on environmental fall prevention recommendations', 'personalized versus generalized education about environmental fall prevention recommendations']",['mean total percentage of adherence'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",24.0,0.0205019,A significant difference was found in the mean total percentage of adherence with recommendations of those receiving personalized education (69%) compared with those receiving generalized education (37%).,"[{'ForeName': 'Suzänne F', 'Initials': 'SF', 'LastName': 'Taylor', 'Affiliation': '1 Senior Clinical Research Coordinator, Department of Physical Medicine and Rehabilitation, School of Medicine, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Constance L', 'Initials': 'CL', 'LastName': 'Coogle', 'Affiliation': '2 Virginia Center on Aging, School of Allied Health Professions, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Cotter', 'Affiliation': '3 Department of Gerontology, School of Allied Health Professions, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'E Ayn', 'Initials': 'EA', 'LastName': 'Welleford', 'Affiliation': '3 Department of Gerontology, School of Allied Health Professions, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Copolillo', 'Affiliation': '4 Department of Occupational Therapy, School of Allied Health Professions, Virginia Commonwealth University, Richmond, VA, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464817723087']
2532,31421989,Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet.,"BACKGROUND
There have been no studies of dual administration of sublingual immunotherapy (SLIT) tablets for perennial and seasonal allergic rhinitis. This trial (JapicCTI-184014) was conducted to investigate the safety profile and immunological response during dual therapy with SQ house dust mite (HDM) and Japanese cedar pollen (JCP) SLIT tablets.
METHODS
This was a multicenter, open-label, randomized trial of 109 Japanese patients with coexisting HDM and JCP allergic rhinitis who had positive tests for HDM- and JCP specific IgE (≥0.7 kU/L). Patients were allocated to receive HDM (N = 54) or JCP (N = 55) SLIT tablets alone for 4 weeks followed by 8 weeks of dual therapy with both SLIT tablets administered within 5 min of each other. Adverse events (AEs), adverse drug reactions (ADRs), and serum IgE and IgG4 specific for HDM (Dermatophagoides farinae, Dermatophagoides pteronyssinus) and JCP were recorded.
RESULTS
The percentage of subjects with AEs and ADRs was similar between the two groups and between the two periods of monotherapy and dual therapy. Most AEs and ADRs were mild in severity, and no serious events were observed. The most common ADRs were local events in the oral cavity. Levels of IgE and IgG4 specific for HDM (D. farinae, D. pteronyssinus) and JCP were increased after treatment with HDM and JCP SLIT tablets, respectively.
CONCLUSIONS
Dual therapy with both SLIT tablets administered within 5 min after 4 weeks of monotherapy with HDM or JCP tablet was well tolerated and induced the expected immunological responses.",2020,"Levels of IgE and IgG4 specific for HDM (D. farinae, D. pteronyssinus) and JCP were increased after treatment with HDM and JCP SLIT tablets, respectively.
","['perennial and seasonal allergic rhinitis', '109 Japanese patients with coexisting HDM and JCP allergic rhinitis who had positive tests for HDM- and JCP specific IgE (≥0.7\xa0kU/L']","['sublingual immunotherapy (SLIT) tablets', 'HDM or JCP', 'JCP (N\xa0', 'SQ house dust mite (HDM) and Japanese cedar pollen (JCP) SLIT tablets', 'HDM', 'dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet']","['safety profile and immunological response', 'Adverse events (AEs), adverse drug reactions (ADRs), and serum IgE and IgG4 specific for HDM (Dermatophagoides farinae, Dermatophagoides pteronyssinus) and JCP', 'Levels of IgE and IgG4 specific for HDM (D.\xa0farinae, D.\xa0pteronyssinus) and JCP', 'immunological responses', 'percentage of subjects with AEs and ADRs']","[{'cui': 'C0018621', 'cui_str': 'Rhinitis, Allergic, Seasonal'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C3539110', 'cui_str': 'house dust mites'}, {'cui': 'C0440380', 'cui_str': 'Japanese cedar pollen (substance)'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0020860', 'cui_str': 'IgG4'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0323677', 'cui_str': 'House Dust Mite, American'}, {'cui': 'C1122992', 'cui_str': 'European House Dust Mite'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",109.0,0.0294341,"Levels of IgE and IgG4 specific for HDM (D. farinae, D. pteronyssinus) and JCP were increased after treatment with HDM and JCP SLIT tablets, respectively.
","[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kimihiro', 'Initials': 'K', 'LastName': 'Okubo', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yuta', 'Affiliation': 'Yuta Clinic, Mie, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Yuta Clinic, Mie, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Nagakura', 'Affiliation': 'Nagakura Ear, Nose and Throat Allergy Clinic, Tokyo, Japan.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Ueyama', 'Affiliation': 'Funai ENT Clinic, Oita, Japan.'}, {'ForeName': 'Tomoyo', 'Initials': 'T', 'LastName': 'Ueyama', 'Affiliation': 'Funai ENT Clinic, Oita, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kawashima', 'Affiliation': 'Osaka Prefectural Hospital Organization, Osaka Habikino Medical Center, Osaka, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Osaka Prefectural Hospital Organization, Osaka Habikino Medical Center, Osaka, Japan.'}, {'ForeName': 'Shigeharu', 'Initials': 'S', 'LastName': 'Fujieda', 'Affiliation': 'Division of Otorhinolaryngology, Head & Neck Surgery, Department of Sensory and Locomotor Medicine, Faculty of Medical Science, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Sakashita', 'Affiliation': 'Division of Otorhinolaryngology, Head & Neck Surgery, Department of Sensory and Locomotor Medicine, Faculty of Medical Science, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka City University, Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Naruhito', 'Initials': 'N', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka City University, Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Mori', 'Affiliation': 'Department of Otorhinolaryngology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Department of Otorhinolaryngology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Ohta', 'Affiliation': 'Division of Otolaryngology, Tohoku Medical and Pharmaceutical University Hospital, Miyagi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kitazawa', 'Affiliation': 'Division of Pediatrics, Tohoku Medical and Pharmaceutical University Hospital, Miyagi, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Okano', 'Affiliation': 'Department of Otorhinolaryngology, International University of Health and Welfare (IUHW), School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Mikiya', 'Initials': 'M', 'LastName': 'Asako', 'Affiliation': 'Division of Otolaryngology, Head and Neck Surgery, Kansai Medical University Medical Center, Osaka, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Takada', 'Affiliation': 'Division of Otolaryngology, Head and Neck Surgery, Kansai Medical University Medical Center, Osaka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Terada', 'Affiliation': 'Department of Otolaryngology, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Inaka', 'Affiliation': 'Department of Otolaryngology, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Syuji', 'Initials': 'S', 'LastName': 'Yonekura', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Yamanashi University, Yamanashi, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Torii Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Torii Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Nagisa', 'Initials': 'N', 'LastName': 'Hijikata', 'Affiliation': 'Torii Pharmaceutical Co., Ltd., Tokyo, Japan. Electronic address: nagisa.hijikata@torii.co.jp.'}, {'ForeName': 'Hisataka', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Torii Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Masuyama', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Yamanashi University, Yamanashi, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2019.07.007']
2533,31423922,"Optimal delay time to initiate anticoagulation after ischemic stroke in atrial fibrillation (START): Methodology of a pragmatic, response-adaptive, prospective randomized clinical trial.","RATIONALE
An estimated 15% of all strokes are associated with untreated atrial fibrillation. Long-term secondary stroke prevention in atrial fibrillation is anticoagulation, increasingly with non-vitamin K oral anticoagulants. The optimal time to initiate anticoagulation following an atrial fibrillation-related stroke that balances hemorrhagic conversion with recurrent stroke is not yet known.
AIMS
To determine if there is an optimal delay time to initiate anticoagulation after atrial fibrillation-related stroke that optimizes the composite outcome of hemorrhagic conversion and recurrent ischemic stroke.
SAMPLE SIZE ESTIMATES
The study will enroll 1500 total subjects split between a mild to moderate stroke cohort (1000) and a severe stroke cohort (500).
METHODS AND DESIGN
This study is a multi-center, prospective, randomized, pragmatic, adaptive trial that randomizes subjects to four arms of time to start of anticoagulation. The four arms for mild to moderate stroke are: Day 3, Day 6, Day 10, and Day 14. The time intervals for severe stroke are: Day 6, Day 10, Day 14, and Day 21. Allocation involves a response adaptive randomization via interim analyses to favor the arms that have a better risk-benefit profile.
STUDY OUTCOMES
The primary outcome event is the composite occurrence of an ischemic or hemorrhagic event within 30 days of the index stroke. Secondary outcomes are also collected at 30 and 90 days.
DISCUSSION
The optimal timing of direct oral anticoagulants post-ischemic stroke requires prospective randomized testing. A pragmatically designed trial with adaptive allocation and randomization to multiple time intervals such as the START trial is best suited to answer this question in order to directly inform current practice on this question.",2019,"To determine if there is an optimal delay time to initiate anticoagulation after atrial fibrillation-related stroke that optimizes the composite outcome of hemorrhagic conversion and recurrent ischemic stroke.
",['1500 total subjects split between a mild to moderate stroke cohort (1000) and a severe stroke cohort (500'],[],['composite occurrence of an ischemic or hemorrhagic event within 30 days of the index stroke'],"[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",,0.18034,"To determine if there is an optimal delay time to initiate anticoagulation after atrial fibrillation-related stroke that optimizes the composite outcome of hemorrhagic conversion and recurrent ischemic stroke.
","[{'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'King', 'Affiliation': 'Department of Neurology, University of Texas Dell Medical School, Austin, TX, USA.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Lawrence', 'Affiliation': 'Department of Neurology, University of Texas Dell Medical School, Austin, TX, USA.'}, {'ForeName': 'Truman J', 'Initials': 'TJ', 'LastName': 'Milling', 'Affiliation': 'Department of Neurology, University of Texas Dell Medical School, Austin, TX, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Warach', 'Affiliation': 'Department of Neurology, University of Texas Dell Medical School, Austin, TX, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019870651']
2534,30987842,"Re: Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial.",,2019,,['Bladder Cancer Patients'],['Radical Cystectomy'],[],"[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]",[],,0.155659,,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Soria', 'Affiliation': 'Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gontero', 'Affiliation': 'Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy. Electronic address: paolo.gontero@unito.it.'}]",European urology,['10.1016/j.eururo.2019.03.042']
2535,31427204,"Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial.","BACKGROUND
In the ongoing phase 3 CheckMate 214 trial, nivolumab plus ipilimumab showed superior efficacy over sunitinib in patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma, with a manageable safety profile. In this study, we aimed to assess efficacy and safety after extended follow-up to inform the long-term clinical benefit of nivolumab plus ipilimumab versus sunitinib in this setting.
METHODS
In the phase 3, randomised, controlled CheckMate 214 trial, patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries. Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to open-label nivolumab (3 mg/kg intravenously) plus ipilimumab (1 mg/kg intravenously) every 3 weeks for four doses, followed by nivolumab (3 mg/kg intravenously) every 2 weeks; or sunitinib (50 mg orally) once daily for 4 weeks (6-week cycle). Randomisation was done through an interactive voice response system, with a block size of four and stratified by risk status and geographical region. The co-primary endpoints for the trial were overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients. Secondary endpoints were overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events in all treated patients. In this Article, we report overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety after extended follow-up. Efficacy outcomes were assessed in all randomly assigned patients; safety was assessed in all treated patients. This study is registered with ClinicalTrials.gov, number NCT02231749, and is ongoing but now closed to recruitment.
FINDINGS
Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients were randomly assigned to nivolumab plus ipilimumab or sunitinib (550 vs 546 in the intention-to-treat population; 425 vs 422 intermediate-risk or poor-risk patients, and 125 vs 124 favourable-risk patients). With extended follow-up (median follow-up 32·4 months [IQR 13·4-36·3]), in intermediate-risk or poor-risk patients, results for the three co-primary efficacy endpoints showed that nivolumab plus ipilimumab continued to be superior to sunitinib in terms of overall survival (median not reached [95% CI 35·6-not estimable] vs 26·6 months [22·1-33·4]; hazard ratio [HR] 0·66 [95% CI 0·54-0·80], p<0·0001), progression-free survival (median 8·2 months [95% CI 6·9-10·0] vs 8·3 months [7·0-8·8]; HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001). Similarly, in intention-to-treat patients, nivolumab and ipilimumab showed improved efficacy compared with sunitinib in terms of overall survival (median not reached [95% CI not estimable] vs 37·9 months [32·2-not estimable]; HR 0·71 [95% CI 0·59-0·86], p=0·0003), progression-free survival (median 9·7 months [95% CI 8·1-11·1] vs 9·7 months [8·3-11·1]; HR 0·85 [95% CI 0·73-0·98], p=0·027), and the proportion of patients achieving an objective response (227 [41%] of 550 vs 186 [34%] of 546 p=0·015). In all treated patients, the most common grade 3-4 treatment-related adverse events in the nivolumab and ipilimumab group were increased lipase (57 [10%] of 547), increased amylase (31 [6%]), and increased alanine aminotransferase (28 [5%]), whereas in the sunitinib group they were hypertension (90 [17%] of 535), fatigue (51 [10%]), and palmar-plantar erythrodysaesthesia (49 [9%]). Eight deaths in the nivolumab plus ipilimumab group and four deaths in the sunitinib group were reported as treatment-related.
INTERPRETATION
The results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediate-risk or poor-risk and intention-to-treat patients with extended follow-up, and show the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma across all risk categories.
FUNDING
Bristol-Myers Squibb and ONO Pharmaceutical.",2019,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","['patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries', 'Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to', 'advanced renal cell carcinoma', 'patients with previously untreated advanced renal cell carcinoma across all risk categories', 'Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients', 'patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma']","['nivolumab plus ipilimumab or sunitinib', 'Nivolumab plus ipilimumab versus sunitinib', 'open-label nivolumab (3 mg/kg intravenously) plus ipilimumab', 'sunitinib', 'nivolumab plus ipilimumab']","['Efficacy outcomes', 'fatigue', 'alanine aminotransferase', 'overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients', 'overall survival', 'adverse events', 'increased amylase', 'progression-free survival', 'overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events', 'progression-free survival ', 'efficacy', 'efficacy and safety', 'hypertension', 'palmar-plantar erythrodysaesthesia', 'proportion of patients achieving an objective response', 'overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety', 'lipase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517571', 'cui_str': '1390 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",1390.0,0.285576,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mskcc.org.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology and Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Arén Frontera', 'Affiliation': 'Department of Medical Oncology, Centro de Invetigación Clínica Bradford Hill, Santiago, Chile.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Salman', 'Affiliation': 'Department of Medical Oncology, Fundación Arturo López Pérez, Santiago, Chile.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Beuselinck', 'Affiliation': 'Department of Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Levine Cancer Institute, Atrium Healthcare, Charlotte, NC, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Neiman', 'Affiliation': 'Department of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel; Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Department of Oncology, Ospedale San Donato, Azienda USL Toscana Sud-Est, IstitutoToscanoTumori, Arezzo, Italy.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Department of Medical Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Raya', 'Initials': 'R', 'LastName': 'Leibowitz-Amit', 'Affiliation': 'Oncology Department, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Sjoukje F', 'Initials': 'SF', 'LastName': 'Oosting', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redman', 'Affiliation': 'Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacky University, and University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Department of Cancer Services: Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex, UK.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Service de Cancérologie Médicale Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pook', 'Affiliation': 'Department of Oncology, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Department of Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Department of Medicine, British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Harrison', 'Affiliation': 'Division of Medical Oncology, Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Niigata University, Niigata, Japan.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Duran', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Genitourinary Oncology at the West-German Cancer Center, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Sabeen', 'Initials': 'S', 'LastName': 'Mekan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30413-9']
2536,32105334,The nature stroke study; NASTRU: A randomized controlled trial of nature-based post-stroke fatigue rehabilitation.,"OBJECTIVE
To determine whether nature-based rehabilitation, as an add-on to standard care, has a long-term influence on post-stroke fatigue, perceived value of everyday occupations, disability, health-related quality of life, anxiety, and depression at follow-up 8 and 14 months after randomization.
DESIGN
Single-blinded, 2-armed, randomized controlled trial.
METHODS
Stroke survivors, identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year previously), were randomized to standard care + nature-based rehabilitation (intervention group) or standard care alone (control group). Blinded evaluations were conducted at follow-up 8 and 14 months after randomization, for the following outcomes: post-stroke fatigue (Mental Fatigue Scale; MFS), perceived value of everyday occupations (Occupational value instrument with pre-defined items), disability (modified Rankin Scale; mRS), health-related quality of life (Euro-QoL-5 Demension Questionnaire), anxiety (Hospital Anxiety and Depression Scale; HAD) and depression (HAD).
RESULTS
Approximately one-quarter of the screened patients were eligible for inclusion in the study; of these, half agreed to participate; a final total of 101 patients were randomized (mean age 67 years, 60% female). The patients with sub-acute stroke were highly compliant with the intervention. The participants in both the intervention and control groups improved, However, no statistically significant differences in improvement were found between the intervention and control groups for any of the outcome measures. Fatigue decreased to a value below the suggested cut-off for mental fatigue (< 10.5) in the intervention group, but not in the control group.
CONCLUSION
Nature-based rehabilitation is feasible and well tolerated. A larger randomized controlled trial is warranted.",2020,"Fatigue decreased to a value below the suggested cut-off for mental fatigue (< 10.5) in the intervention group, but not in the control group.
","['patients with sub-acute stroke', 'Stroke survivors, identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke >\u20091 year previously', 'Approximately one-quarter of the screened patients were eligible for inclusion in the study; of these, half agreed to participate; a final total of 101 patients were randomized (mean age 67 years, 60% female']","['standard care + nature-based rehabilitation (intervention group) or standard care alone (control group', 'nature-based post-stroke fatigue rehabilitation']","['Fatigue', 'stroke fatigue (Mental Fatigue Scale; MFS), perceived value of everyday occupations (Occupational value instrument with pre-defined items), disability (modified Rankin Scale; mRS), health-related quality of life (Euro-QoL-5 Demension Questionnaire), anxiety (Hospital Anxiety and Depression Scale; HAD) and depression (HAD', 'everyday occupations, disability, health-related quality of life, anxiety, and depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C0222045'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",101.0,0.129872,"Fatigue decreased to a value below the suggested cut-off for mental fatigue (< 10.5) in the intervention group, but not in the control group.
","[{'ForeName': 'Anna María', 'Initials': 'AM', 'LastName': 'Pálsdóttir', 'Affiliation': ''}, {'ForeName': 'Kjerstin', 'Initials': 'K', 'LastName': 'Stigmar', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Norrving', 'Affiliation': ''}, {'ForeName': 'Ingemar F', 'Initials': 'IF', 'LastName': 'Petersson', 'Affiliation': ''}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Åström', 'Affiliation': ''}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pessah-Rasmussen', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2652']
2537,32495463,The effect of a short burst of exercise during the night on subsequent sleep.,"When on-call workers wake during the night to perform work duties, they may experience reduced alertness and impaired performance as a result of sleep inertia. After performing their duties, on-call workers may have the opportunity to return to sleep. Thus, it is important that sleep inertia countermeasures do not affect subsequent sleep. Exercise may be a suitable countermeasure; however, the impact on subsequent sleep is untested. Healthy participants (n = 15) completed three conditions in a counterbalanced order: sedentary, low-intensity exercise or high-intensity exercise, performed for 2 min upon awakening. Sleep was recorded 2 hr later using polysomnography, the Karolinska Sleepiness Scale was administered to measure subjective sleepiness, and core body temperature was measured continuously. Results indicate there was no effect of condition on most sleep variables; however, three variables had small differences, with longer total sleep time (p = .006), higher sleep efficiency (p = .006) and shorter N3 latency (p < .001) in the low-intensity exercise condition. There was no difference in subjective sleepiness (p = .124) or core body temperature (p = .216) 90 min after the exercise intervention. These results indicate that using a short burst of exercise to counteract sleep inertia when woken during the night may be a suitable countermeasure for on-call workers who not only need to be alert upon waking but also need quality sleep when returning to bed. Future research could include participants of other ages and health statuses to investigate whether the results are generalizable.",2020,There was no difference in subjective sleepiness (p = .124) or core body temperature (p = .216),['Healthy participants (n\xa0=\xa015) completed three conditions in a counterbalanced order: sedentary'],"['low-intensity exercise or high-intensity exercise, performed for 2\xa0min upon awakening']","['higher sleep efficiency', 'Karolinska Sleepiness Scale', 'total sleep time', 'subjective sleepiness', 'subjective sleepiness, and core body temperature', 'Sleep', 'shorter N3 latency']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",,0.0141769,There was no difference in subjective sleepiness (p = .124) or core body temperature (p = .216),"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dominiak', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Kovac', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Reynolds', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Ferguson', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Vincent', 'Affiliation': 'Appleton Institute, Central Queensland University, Adelaide, SA, Australia.'}]",Journal of sleep research,['10.1111/jsr.13077']
2538,32134320,Factors contributing to symptom change in standardized and individualized Internet-based interventions for depression: A randomized-controlled trial.,"Research suggests 4 categories of outcome predictors in face-to-face therapy (i.e., treatment expectations, extratherapeutic factors, relationship factors, and factors specific to a treatment approach/technique). However, it is unclear whether these factors are relevant in standardized and individualized Internet-based interventions. To investigate this question, a secondary analysis of data from 1,089 mildly to moderately depressed adults undergoing 6 weeks of cognitive-behavioral Internet-based intervention for depression randomized to receive either weekly written feedback individualized by a counselor or automated and fully standardized feedback was performed. The following variables corresponding to the 4 categories were tested regarding associations with depressive symptom change during multiple treatment periods within a multigroup structural equation model: (a) outcome expectations, (b) extratherapeutic stressors and stress change during treatment, (c) midtreatment working alliance (task/goal and bond), and (d) uptake of treatment-specific components (logins and specific tool use). Results suggest similar regressive associations across treatment conditions: Previous symptom change was the most important predictor for subsequent symptom developments. Stress at baseline and the uptake of specific treatment components only played a minor role, and stronger task/goal ratings were associated with later symptom improvements. Early symptom improvements predicted stronger midtreatment task/goal and bond ratings, whereas only stronger task/goal ratings were associated with later symptom improvements. Outcome expectations were only indirectly related with symptom change mediated through goal/task ratings. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Early symptom improvements predicted stronger midtreatment task/goal and bond ratings, whereas only stronger task/goal ratings were associated with later symptom improvements.","['1,089 mildly to moderately depressed adults undergoing 6 weeks of cognitive-behavioral Internet-based intervention for depression randomized to receive either']",['weekly written feedback individualized by a counselor or automated and fully standardized feedback'],"['stronger task/goal ratings', 'stronger midtreatment task/goal and bond ratings', 'symptom change mediated through goal/task ratings', 'extratherapeutic stressors and stress change during treatment, (c) midtreatment working alliance (task/goal and bond), and (d) uptake of treatment-specific components (logins and specific tool use', 'depressive symptom change']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.056975,"Early symptom improvements predicted stronger midtreatment task/goal and bond ratings, whereas only stronger task/goal ratings were associated with later symptom improvements.","[{'ForeName': 'Pavle', 'Initials': 'P', 'LastName': 'Zagorscak', 'Affiliation': 'Department of Clinical-Psychological Intervention, Freie Universität Berlin.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Heinrich', 'Affiliation': 'Department of Clinical-Psychological Intervention, Freie Universität Berlin.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Schulze', 'Affiliation': 'Department of Psychological Assessment, Differential and Personality Psychology, Freie Universität Berlin.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Böttcher', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Freie Universität Berlin.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Knaevelsrud', 'Affiliation': 'Department of Clinical-Psychological Intervention, Freie Universität Berlin.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000276']
2539,32438250,Ante-and post-mortem strategies to improve the meat quality of high-value muscles harvested from farmed male common eland (Taurotragus oryx).,"The effects of immunocastration, pelvic suspension and wet ageing on the meat quality of the longissimus lumborum et thoracis (LTL) and biceps femoris (BF) muscles of male common eland were evaluated. Ten subadult males were either immunocastrated (n = 5) or remained intact (n = 5) throughout a four-month growth trial, after which their carcass sides were randomly allocated to either pelvic- or Achilles-suspension. The LTL and BF were further aged for 14 days, measuring changes in the physical quality weekly. The sensory quality of the LTL and BF were determined after ageing (8/9 days, respectively). Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force. All muscles reached minimum shear force after seven days of ageing, and the panellists ranked the pelvic-suspended muscles higher for tenderness traits. Incorporating pelvic suspension and wet ageing into the commercial processing of eland carcasses should be considered to improve overall meat quality.",2020,"Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force.","['Ten subadult males were either immunocastrated (n\xa0=\xa05) or remained intact (n\xa0=\xa05) throughout a four-month growth trial, after which their carcass sides', 'high-value muscles harvested from farmed male common eland (Taurotragus oryx']","['pelvic- or Achilles-suspension', 'immunocastration, pelvic suspension and wet ageing']","['meat quality of the longissimus lumborum et thoracis (LTL) and biceps femoris (BF) muscles', 'sensory quality of the LTL and BF', 'overall meat quality']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0325245', 'cui_str': 'Taurotragus oryx'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",10.0,0.0142914,"Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force.","[{'ForeName': 'Tersia', 'Initials': 'T', 'LastName': 'Needham', 'Affiliation': 'Department of Animal Science and Food Processing, Faculty of Tropical AgriSciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic. Electronic address: needham@ftz.czu.cz.'}, {'ForeName': 'Radim', 'Initials': 'R', 'LastName': 'Kotrba', 'Affiliation': 'Department of Animal Science and Food Processing, Faculty of Tropical AgriSciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic; Department of Ethology, Institute of Animal Science, Přátelství 815, Prague 10- Uhříněves, 104 00, Czech Republic.'}, {'ForeName': 'Louwrens C', 'Initials': 'LC', 'LastName': 'Hoffman', 'Affiliation': 'Department of Animal Sciences, University of Stellenbosch, Private Bag X1, Matieland, Stellenbosch 7602, South Africa; Centre for Nutrition and Food Sciences, Queensland Alliance for Agriculture and Food Innovation (QAAFI), The University of Queensland, Health and Food Sciences Precinct, 39 Kessels Rd, Coopers Plains 4108. Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bureš', 'Affiliation': 'Department of Cattle Breeding, Institute of Animal Science, Přátelství 815, Prague 10- Uhříněves, 104 00, Czech Republic; Department of Food Quality, Faculty of Agrobiology, Food and Natural Sciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic.'}]",Meat science,['10.1016/j.meatsci.2020.108183']
2540,31424503,"Short-term diuretic withdrawal in stable outpatients with mild heart failure and no fluid retention receiving optimal therapy: a double-blind, multicentre, randomized trial.","AIMS
Although loop diuretics are widely used to treat heart failure (HF), there is scarce contemporary data to guide diuretic adjustments in the outpatient setting.
METHODS AND RESULTS
In a prospective, randomized and double-blind protocol, we tested the safety and tolerability of withdrawing low-dose furosemide in stable HF outpatients at 11 HF clinics in Brazil. The trial had two blindly adjudicated co-primary outcomes: (i) symptoms assessment quantified as the area under the curve (AUC) of a dyspnoea score on a visual-analogue scale evaluated at 4 time-points (baseline, Day 15, Day 45, and Day 90) and (ii) the proportion of patients maintained without diuretic reuse during follow-up. We enrolled 188 patients (25% females; 59 ± 13 years old; left ventricular ejection fraction = 32 ± 8%) that were randomized to furosemide withdrawal (n = 95) or maintenance (n = 93). For the first co-primary endpoint, no significant difference in patients' assessment of dyspnoea was observed in the comparison of furosemide withdrawal with continuous administration [median AUC 1875 (interquartile range, IQR 383-3360) and 1541 (IQR 474-3124), respectively; P = 0.94]. For the second co-primary endpoint, 70 patients (75.3%) in the withdrawal group and 77 patients (83.7%) in the maintenance group were free of furosemide reuse during follow-up (odds ratio for additional furosemide use with withdrawal 1.69, 95% confidence interval 0.82-3.49; P = 0.16). Heart failure-related events (hospitalizations, emergency room visits, and deaths) were infrequent and similar between groups (P = 1.0).
CONCLUSIONS
Diuretic withdrawal did not result in neither increased self-perception of dyspnoea nor increased need of furosemide reuse. Diuretic discontinuation may deserve consideration in stable outpatients with no signs of fluid retention receiving optimal medical therapy.
CLINICALTRIALS.GOV IDENTIFIER
NCT02689180.",2019,"CONCLUSIONS
Diuretic withdrawal did not result in neither increased self-perception of dyspnoea nor increased need of furosemide reuse.","['stable outpatients with mild heart failure and no fluid retention receiving optimal therapy', 'stable HF outpatients at 11 HF clinics in Brazil', 'stable outpatients with no signs of fluid retention receiving optimal medical therapy', '188 patients (25% females; 59\u2009±\u200913\u2009years old; left ventricular ejection fraction\u2009=\u200932\u2009±\u20098']","['furosemide withdrawal', 'withdrawing low-dose furosemide', 'Diuretic discontinuation']","['safety and tolerability', 'self-perception of dyspnoea', 'symptoms assessment quantified as the area under the curve (AUC) of a dyspnoea score on a visual-analogue scale', 'Heart failure-related events (hospitalizations, emergency room visits, and deaths', ""patients' assessment of dyspnoea"", 'free of furosemide reuse']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0268000', 'cui_str': 'Body fluid retention (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}]",188.0,0.149786,"CONCLUSIONS
Diuretic withdrawal did not result in neither increased self-perception of dyspnoea nor increased need of furosemide reuse.","[{'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Rohde', 'Affiliation': 'Hospital de Clínicas de Porto Alegre and Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, CEP, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Marciane M', 'Initials': 'MM', 'LastName': 'Rover', 'Affiliation': 'Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Figueiredo Neto', 'Affiliation': 'Hospital Universitário da Universidade Federal do Maranhão, São Luis, MA, Brazil.'}, {'ForeName': 'Luiz C', 'Initials': 'LC', 'LastName': 'Danzmann', 'Affiliation': 'Hospital Universitário da Universidade Luterana do Brasil, Canoas, RS, Brazil.'}, {'ForeName': 'Eduardo G', 'Initials': 'EG', 'LastName': 'Bertoldi', 'Affiliation': 'Hospital Escola da Universidade Federal de Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Marcus V', 'Initials': 'MV', 'LastName': 'Simões', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Odilson M', 'Initials': 'OM', 'LastName': 'Silvestre', 'Affiliation': 'Universidade Federal do Acre, Rio Branco, AC, Brazil.'}, {'ForeName': 'Antonio L P', 'Initials': 'ALP', 'LastName': 'Ribeiro', 'Affiliation': 'Hospital da Clinicas e Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Lidia Zytynski', 'Initials': 'LZ', 'LastName': 'Moura', 'Affiliation': 'Hospital Universitário Cajuru da Pontifícia Universidade Católica, Curitiba, PR, Brazil.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Beck-da-Silva', 'Affiliation': 'Hospital de Clínicas de Porto Alegre and Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, CEP, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Prado', 'Affiliation': 'Hospital da Clinicas e Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Roberto T', 'Initials': 'RT', 'LastName': ""Sant'Anna"", 'Affiliation': 'Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Leonardo H', 'Initials': 'LH', 'LastName': 'Bridi', 'Affiliation': 'Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, RS, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Zimerman', 'Affiliation': 'Hospital de Clínicas de Porto Alegre and Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, CEP, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Raupp da Rosa', 'Affiliation': 'Hospital São Lucas da Pontifícia Universidade Católica, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Andréia', 'Initials': 'A', 'LastName': 'Biolo', 'Affiliation': 'Hospital de Clínicas de Porto Alegre and Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, CEP, Porto Alegre, RS, Brazil.'}]",European heart journal,['10.1093/eurheartj/ehz554']
2541,31286387,Long-term effectiveness and cost-effectiveness of an 18-week supervised exercise program in patients treated with autologous stem cell transplantation: results from the EXIST study.,"PURPOSE
To evaluate the long-term effectiveness and cost-effectiveness of a supervised 18-week high-intensity exercise program compared with usual care in patients treated with autologous stem cell transplantation.
METHODS
One hundred nine patients were randomly assigned to the exercise intervention (n = 54) or the usual care control group (n = 55). Data on cardiorespiratory fitness (VO 2 peak), handgrip strength, general fatigue, and health-related quality of life (quality-adjusted life years [QALYs]) were collected at baseline (T0), after completion of the exercise intervention or at a similar time point in the control group (T1) and 12 months later (T2). Cost questionnaires were used to assess societal costs. Long-term effectiveness (at T2) was evaluated using linear mixed model analyses. For the economic evaluation, missing data were imputed using multiple imputation, and data were analyzed using linear mixed models.
RESULTS
At T2, no statistically significant differences were found between the intervention and control group for VO 2 peak (0.12; 95%CI - 1.89; 2.14 ml/min/kg), handgrip strength (- 1.08; 95%CI- 2.47; 2.31), and general fatigue (- 0.69; 95%CI - 2.52; 1.14). During 12-months follow-up, no significant between-group differences in QALYs and societal costs were found (QALYs - 0.07; 95%CI - 0.17; 0.04; costs 529; 95%CI - 3205;4452). Intervention costs were €1340 per patient. For all outcomes, the probability of the intervention being cost-effective was low at reasonable values of willingness-to-pay.
CONCLUSION
We found no evidence for the exercise intervention being effective on physical fitness and fatigue, nor cost-effective from a societal perspective.
TRIAL REGISTRATION
The study was prospectively registered on 27 May 2010 at the Netherlands Trial Register ( NTR2341 ).
IMPLICATIONS FOR CANCER SURVIVORS
The current exercise intervention should not be recommended to patients recently treated with autologous stem cell transplantation.",2019,"During 12-months follow-up, no significant between-group differences in QALYs and societal costs were found (QALYs - 0.07; 95%CI - 0.17; 0.04; costs 529; 95%CI - 3205;4452).","['FOR CANCER SURVIVORS', '27 May 2010 at the Netherlands Trial Register ( NTR2341 ', 'patients treated with autologous stem cell transplantation', 'One hundred nine patients']","['supervised 18-week high-intensity exercise program', 'current exercise intervention', 'exercise intervention', 'autologous stem cell transplantation', '18-week supervised exercise program', 'usual care control group']","['cardiorespiratory fitness (VO 2 peak), handgrip strength, general fatigue, and health-related quality of life (quality-adjusted life years [QALYs', 'probability of the intervention being cost-effective', 'QALYs and societal costs', 'general fatigue', 'handgrip strength', 'Intervention costs', 'societal costs', 'physical fitness and fatigue, nor cost-effective']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",109.0,0.0862264,"During 12-months follow-up, no significant between-group differences in QALYs and societal costs were found (QALYs - 0.07; 95%CI - 0.17; 0.04; costs 529; 95%CI - 3205;4452).","[{'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Vrije Universiteit Amsterdam, Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Persoon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Jongeneel', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, De Boelelaan 1089a, 1018HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Vrije Universiteit Amsterdam, Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marie José', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Haematology, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brug', 'Affiliation': 'National Institute for Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Mai J M', 'Initials': 'MJM', 'LastName': 'Chinapaw', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Laurien M', 'Initials': 'LM', 'LastName': 'Buffart', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, De Boelelaan 1089a, 1018HV, Amsterdam, The Netherlands. l.buffart@vumc.nl.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00775-9']
2542,32438192,MicroRNA expression in response to bisphenol A is associated with high blood pressure.,"Bisphenol A (BPA) is a ubiquitous environmental contaminant that is known to be associated with the risk of arterial hypertension. However, the underlying mechanisms describing how BPA exposure leads to high blood pressure (BP) and the role of epigenetics are still unclear. Therefore, we evaluated associations among BPA exposure, microRNA (miRNA) expression, and BP in a randomized crossover trial with 45 non-smoking females over 60 years of age. The participants visited the study site 3 times and were dose-dependently exposed to BPA. Two hours after exposure to BPA, urine and whole blood were collected for BPA measurement and miRNA profiling, and BP was measured. Relationships among urinary BPA level, miRNA expression, and BP were estimated using the mixed effect model. Decreases in miR-30a-5p, miR-580-3p, miR-627-5p, and miR-671-3p and increases in miR-636 and miR-1224-3p attributable to BPA exposure were associated with high BP. The core functional network from BPA exposure to increased BP was found to be on the pathway through these six miRNAs and their predicted BP-related target genes. Our results suggest that epigenetic biomarkers for BPA exposure and hypertension provide mechanistic data to explain hypertension exacerbation as well as key information for predicting the health effects of BPA exposure.",2020,"Decreases in miR-30a-5p, miR-580-3p, miR-627-5p, and miR-671-3p and increases in miR-636 and miR-1224-3p attributable to BPA exposure were associated with high BP.",['45 non-smoking females over 60\xa0years of age'],['Bisphenol A (BPA'],"['urinary BPA level, miRNA expression, and BP', 'blood pressure (BP', 'BPA exposure, microRNA (miRNA) expression, and BP', 'BPA measurement and miRNA profiling, and BP']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0053800', 'cui_str': 'bisphenol A'}]","[{'cui': 'C0053800', 'cui_str': 'bisphenol A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",45.0,0.0257088,"Decreases in miR-30a-5p, miR-580-3p, miR-627-5p, and miR-671-3p and increases in miR-636 and miR-1224-3p attributable to BPA exposure were associated with high BP.","[{'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Integrative Bioscience & Biotechnology, Sejong University, Seoul 05006, Republic of Korea. Electronic address: jhkim777@sejong.ac.kr.'}, {'ForeName': 'Yoon Hee', 'Initials': 'YH', 'LastName': 'Cho', 'Affiliation': 'Department of Biomedical and Pharmaceutical Sciences, The University of Montana, Montana 59812-1552, USA. Electronic address: unicho3@gmail.com.'}, {'ForeName': 'Yun-Chul', 'Initials': 'YC', 'LastName': 'Hong', 'Affiliation': 'Department of Preventive Medicine, Seoul National University College of Medicine, Seoul 110-799, Republic of Korea.'}]",Environment international,['10.1016/j.envint.2020.105791']
2543,31421060,Pythagorean self-awareness intervention: A novel cognitive stress management technique for body weight control.,"BACKGROUND
Over the past decades, the prevalence of obesity has markedly increased worldwide. Stress is recognized as a substantial contributor to increased body weight; therefore, stress management interventions, especially cognitive behavioural, are becoming increasingly popular. The impact of stress management on stress- and obesity-related biomarkers (eg blood lipid profile, HBA1c, inflammatory biomarkers, such as CRP) has been scarcely studied. The aim of this study was to assess the effect of a novel cognitive behavioural stress management intervention, called 'Pythagorean Self-Awareness Intervention' (PSAI), in overweight/obese adults.
MATERIALS AND METHODS
This was a two-armed 1:1 randomized, nonblind controlled study including overweight/obese individuals. The control group followed a personalized Mediterranean low-calorie diet, and the intervention group followed the same diet in addition to the PSAI intervention for 8 weeks. Measurements included demographic, anthropometric (ie BMI, waist-to-hip ratio), stress (ie perceived stress, salivary cortisol), dietary behaviour (ie emotional eating) and metabolic parameters (ie blood lipid profile, HBA1c, CRP, body composition in fat and water). Outcome per-protocol analysis was performed using mixed linear models adjusted for age and gender.
RESULTS
A total of 49 of 62 eligible adults were analysed in the study (there were three dropouts in the intervention group and 10 dropouts in the control group); 28 were assigned to the intervention group (mean age 54.7 ± 11.9 years) and 21 to the control group (mean age 51.8 ± 11.9 years). The intervention group showed a statistically significant decrease in perceived stress, cortisol concentrations 30 minutes after awakening, cortisol's area under the curve, BMI, waist-to-hip ratio, restrained, emotional and external eating behaviour, fasting glucose, LDL, triglycerides, HbA1c and body and trunk fat, compared with the control group. Based on the observed effect sizes, clinically meaningful changes may be more evident in stress perception, restrained and external eating behaviour, Hb1ac and trunk fat. The compliance to the PSAI intervention reached 100%, and there were no adverse effects.
CONCLUSIONS
The PSAI technique may be an effective stress management method for overweight/obese adults. Future and larger randomized controlled studies are needed to allow generalization of these findings.",2019,"The intervention group showed a statistically significant decrease of perceived stress, cortisol concentrations 30 minutes after awakening, cortisol's area under the curve, BMI, waist-to-hip ratio, restrained, emotional and external eating behavior, fasting glucose, LDL, triglycerides, HbA1c, and body and trunk fat, compared to the control group.","['overweight/obese individuals', 'A total of 49 of 62 eligible adults were analyzed in the study (there were 3 drop-outs in the intervention group and 10 drop-outs in the control group); 28 were assigned to the intervention group (mean age 54.7±11.9 years) and 21 to the control group (mean age 51.8±11.9 years', 'overweight/obese adults']","['novel cognitive-behavioral stress management intervention, called ""Pythagorean Self-Awareness Intervention"" (PSAI', 'Pythagorean Self-Awareness Intervention (PSAI', 'personalized Mediterranean low-calorie diet and the intervention group followed the same diet in addition to the PSAI intervention']","['stress perception, restrained and external eating behavior, Hb1ac and trunk fat', ""perceived stress, cortisol concentrations 30 minutes after awakening, cortisol's area under the curve, BMI, waist-to-hip ratio, restrained, emotional and external eating behavior, fasting glucose, LDL, triglycerides, HbA1c, and body and trunk fat"", 'demographic, anthropometric (i.e. BMI, waist-to-hip ratio), stress (i.e., perceived stress, salivary cortisol), dietary behavior (i.e., emotional eating) and metabolic parameters (i.e., blood lipid profile, HBA1c, CRP, body composition in fat and water', 'adverse effects']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self (observable entity)'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",62.0,0.0280233,"The intervention group showed a statistically significant decrease of perceived stress, cortisol concentrations 30 minutes after awakening, cortisol's area under the curve, BMI, waist-to-hip ratio, restrained, emotional and external eating behavior, fasting glucose, LDL, triglycerides, HbA1c, and body and trunk fat, compared to the control group.","[{'ForeName': 'Dimitrios S', 'Initials': 'DS', 'LastName': 'Simos', 'Affiliation': 'Postgraduate Course Stress Management and Health Promotion, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Kokkinos', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, Diabetes Center, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Tentolouris', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, Diabetes Center, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Charilaos', 'Initials': 'C', 'LastName': 'Dimosthenopoulos', 'Affiliation': 'Department of Clinical Nutrition, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Mantzou', 'Affiliation': ""Division of Endocrinology, Metabolism and Diabetes, First Department of Pediatrics, Medical School, Aghia Sophia Children's Hospital, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Artemios', 'Initials': 'A', 'LastName': 'Artemiadis', 'Affiliation': 'Postgraduate Course Stress Management and Health Promotion, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Bacopoulou', 'Affiliation': ""First Department of Pediatrics, Medical School, Center for Adolescent Medicine and UNESCO Chair on Adolescent Health Care, Aghia Sophia Children's Hospital, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Nicolas C', 'Initials': 'NC', 'LastName': 'Nicolaides', 'Affiliation': 'Postgraduate Course Stress Management and Health Promotion, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ourania', 'Initials': 'O', 'LastName': 'Kosta', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, Medical School, Diabetes Center, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Chrousos', 'Affiliation': 'Postgraduate Course Stress Management and Health Promotion, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Darviri', 'Affiliation': 'Postgraduate Course Stress Management and Health Promotion, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}]",European journal of clinical investigation,['10.1111/eci.13164']
2544,30640287,Functional Resistance Training and Affective Response in Female College-Age Students.,"INTRODUCTION
Although resistance training (RT) can lead to acute improvements in psychological, physiological and psychosocial outcomes, prevalence rates remain low in college-age females likely due to perceived barriers. This study compared the effects of an acute bout of both a functional RT (FRT) and traditional RT (TRT) session on affect, state anxiety enjoyment and physiological measures.
METHODS
Females (n = 34, mean age = 27 ± 4.5 yr) not currently meeting American College of Sports Medicine RT guidelines completed four sessions (2 FRT, 2 TRT) within 4 wk in a randomized crossover design. Session 1 familiarized participants to the RT exercises. Session 2 consisted of 2 × 10 moderate intensity repetitions. Outcome measures included affect and state anxiety (preexercise, postexercise, and 15 min postexercise); enjoyment (post), and manipulation measures of session RPE and HR).
RESULTS
Between-condition comparisons indicate change scores in state anxiety pre- to post-15 (P = 0.028) and enjoyment levels post- (P = 0.02) were significantly greater in FRT than TRT. Within-condition analyses revealed pre- to post-15 changes in affect were positive and greater in FRT (d = 0.79) than TRT (d = 0.53, P = 0.47), and greater in decreases in state anxiety (FRT, d = -0.58; TRT, d = -0.37, P = 0.028). Mean session RPE was not significantly different between conditions (FRT 6 ± 1.2 units; TRT 6.3 ± 1.1 units; P = 0.11), though average percent of age-predicted maximum HR (FRT 68.7 ± 7.6; TRT 57.1 ± 8.4) was significantly different (P < 0.01).
CONCLUSIONS
Findings suggest that compared with TRT, FRT is associated with higher acute positive psychological states, higher levels of enjoyment, and greater energy expenditure. Future studies are recommended to examine additional measures of affect and in-task timepoints to determine how these responses relate to maintenance and adherence, thereby potentially increasing the proportion of college females meeting American College of Sports Medicine RT and moderate-to-vigorous physical activity guidelines.",2019,"RESULTS
Between-condition comparisons indicate change scores in state anxiety pre- to post-15 (P = 0.028) and enjoyment levels post-","['Female College-Age Students', 'college females meeting American College of Sports Medicine RT and moderate-to-vigorous physical activity guidelines', 'Females (n = 34, mean age = 27 ± 4.5 yr) not currently meeting American College of Sports Medicine RT guidelines completed four sessions (2 FRT, 2 TRT) within 4 wk']","['TRT', 'functional RT (FRT) and traditional RT (TRT) session', 'TRT, FRT', 'Functional Resistance Training', 'resistance training (RT']","['affect and state anxiety (preexercise, postexercise, and 15 min postexercise); enjoyment (post), and manipulation measures of session RPE and HR', 'FRT', 'Mean session RPE', 'state anxiety enjoyment and physiological measures', 'state anxiety', 'enjoyment levels post', 'acute positive psychological states, higher levels of enjoyment, and greater energy expenditure']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}]",34.0,0.0493177,"RESULTS
Between-condition comparisons indicate change scores in state anxiety pre- to post-15 (P = 0.028) and enjoyment levels post-","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Faro', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Wright', 'Affiliation': 'Department of Exercise and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Hayman', 'Affiliation': 'Department of Nursing, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Hastie', 'Affiliation': 'Department of Health Sciences, Lasell College, Newton, MA.'}, {'ForeName': 'Philimon N', 'Initials': 'PN', 'LastName': 'Gona', 'Affiliation': 'Department of Exercise and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Whiteley', 'Affiliation': 'Department of Exercise and Health Sciences, University of Massachusetts Boston, Boston, MA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000001895']
2545,32014275,Salvage surgery in head and neck cancer: Does it improve outcomes?,"BACKGROUND
Studies reporting outcomes of salvage surgery in locally advanced head and neck squamous cell carcinoma (LAHNSCC) have inherent biases like biological and temporal selection. Our study considered all patients deemed fit for salvage surgery and compared to those who underwent surgery versus those who refused it thus throwing light on the real world benefit of salvage surgery.
METHODS
This was a post hoc analysis of a phase 3 randomized trial conducted between 2012 and 2018. Out of 536 LAHNSCC patients randomised in the study, 113 patients had residual disease or recurrent disease and were planned for salvage surgery in a multidisciplinary clinic. Patients were divided into 2 cohorts for comparison, willing for salvage surgery (n = 91) and unwilling for salvage surgery(n = 22). The primary endpoint was overall survival.
RESULTS
The median follow up was 28.7 months (95%CI 23.9-33.5 months). Out of the 91 patients who were willing for salvage surgery, 78 underwent same. The median survival in cohort of patients willing for salvage surgery was 22.0 months (95%CI 10.1-33.9) while it was 9.7 months (95%CI 6.6-12.8) in patients who were unwilling for salvage surgery (HR = 0.262 95%CI HR 0.147-0.469, p = 0.000).
CONCLUSION
Salvage surgery leads to a substantial improvement in outcomes in head and neck cancers and should be the de facto standard of care in patients who are eligible for the same.",2020,"The median survival in cohort of patients willing for salvage surgery was 22.0 months (95%CI 10.1-33.9) while it was 9.7 months (95%CI 6.6-12.8) in patients who were unwilling for salvage surgery (HR = 0.262 95%CI HR 0.147-0.469, p = 0.000).
","['91 patients who were willing for salvage surgery, 78 underwent same', 'head and neck cancers', '536 LAHNSCC patients randomised in the study, 113 patients had residual disease or recurrent disease and were planned for salvage surgery in a multidisciplinary clinic', 'head and neck cancer', '2012 and 2018', 'locally advanced head and neck squamous cell carcinoma (LAHNSCC', 'patients who are eligible for the same']","['Salvage surgery', 'salvage surgery']","['overall survival', 'median survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease (disorder)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}]","[{'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",536.0,0.0925169,"The median survival in cohort of patients willing for salvage surgery was 22.0 months (95%CI 10.1-33.9) while it was 9.7 months (95%CI 6.6-12.8) in patients who were unwilling for salvage surgery (HR = 0.262 95%CI HR 0.147-0.469, p = 0.000).
","[{'ForeName': 'Vijay Maruti', 'Initials': 'VM', 'LastName': 'Patil', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Shivakumar', 'Initials': 'S', 'LastName': 'Thiagarajan', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Chandrasekharan', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Talreja', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Jaiprakash', 'Initials': 'J', 'LastName': 'Agarwal', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Sarbani', 'Initials': 'S', 'LastName': 'Ghosh-Laskar', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Budrukkar', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Shashikant', 'Initials': 'S', 'LastName': 'Juvekar', 'Affiliation': 'Department of Radiology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Department of Radiology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Archi', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Nuclear Medicine, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Nilendu', 'Initials': 'N', 'LastName': 'Purandare', 'Affiliation': 'Department of Nuclear Medicine, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Bhattacharjee', 'Affiliation': 'Department of Epidemiology, Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': ""D'Cruz"", 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Prathamesh S', 'Initials': 'PS', 'LastName': 'Pai', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Chaukar', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, HBNI, Mumbai, India. Electronic address: kumarprabhashtmh@gmail.com.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2020.01.019']
2546,32495306,Development of an Intervention to Promote Physical Activity and Reduce Dietary Sodium Intake for Preventing Hypertension and Chronic Disease in Filipino Americans.,"Hypertension is a common chronic health condition affecting Filipino Americans. This pilot study examined the feasibility of addressing high rates of hypertension among Filipino Americans through the implementation of a culturally tailored education intervention. Filipino Americans living in the Greater Philadelphia Area were recruited through community-based organizations for participation and were engaged using a community-based participatory research (CBPR) framework. The study included pre- and post-intervention blood pressure measurements, self-reported body mass index, and questionnaires about physical activity and salt intake. The intervention to promote physical activity and reduce salt intake was conducted through two educational sessions and was accompanied by follow-up at 3 months and by the collection of urine samples for 24-h urinary sodium intake biomarker analysis. Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups. For systolic blood pressure, a reduction of 12.6 mmHg and an increase in 5.3 mmHg was observed in the intervention and control groups, respectively. Diastolic pressure decreased 3.8 mmHg for the intervention group and increased 5.6 mmHg among controls. The culturally tailored education intervention reported here represents a promising tool for blood pressure reduction in high-risk ethnic populations. The methods used were effective for the recruitment and retention of ethnic minorities in a community-based setting.",2020,"Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups.","['Filipino Americans', 'Filipino Americans living in the Greater Philadelphia Area were recruited through community-based organizations for participation and were engaged using a community-based participatory research (CBPR) framework']","['Intervention to Promote Physical Activity and Reduce Dietary Sodium Intake', 'culturally tailored education intervention']","['Diastolic pressure', 'pre- and post-intervention blood pressure measurements, self-reported body mass index, and questionnaires about physical activity and salt intake', 'systolic blood pressure', 'urine sodium']","[{'cui': 'C0597918', 'cui_str': 'Filipino Americans'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine'}]",,0.0143801,"Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups.","[{'ForeName': 'Grace X', 'Initials': 'GX', 'LastName': 'Ma', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA. grace.ma@temple.edu.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Bhimla', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Beeber', 'Affiliation': 'Hunter College, The City University of New York (CUNY), New York, NY, USA.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Aczon', 'Affiliation': 'Filipino American Society of South Jersey Inc., Mount Laurel, NJ, 08084, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Sally Boyle', 'Initials': 'SB', 'LastName': 'Quinn', 'Affiliation': 'Division of Nephrology, Temple University School of Medicine, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Crystal A', 'Initials': 'CA', 'LastName': 'Gadegbeku', 'Affiliation': 'Division of Nephrology, Temple University School of Medicine, Philadelphia, PA, 19140, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-020-00781-z']
2547,31427751,"Effects of immunomodulatory drugs on depressive symptoms: A mega-analysis of randomized, placebo-controlled clinical trials in inflammatory disorders.","Activation of the innate immune system is commonly associated with depression. Immunomodulatory drugs may have efficacy for depressive symptoms that are co-morbidly associated with inflammatory disorders. We report a large-scale re-analysis by standardized procedures (mega-analysis) of patient-level data combined from 18 randomized clinical trials conducted by Janssen or GlaxoSmithKline for one of nine disorders (N = 10,743 participants). Core depressive symptoms (low mood, anhedonia) were measured by the Short Form Survey (SF-36) or the Hospital Anxiety and Depression Scale (HADS), and participants were stratified into high (N = 1921) versus low-depressive strata based on baseline ratings. Placebo-controlled change from baseline after 4-16 weeks of treatment was estimated by the standardized mean difference (SMD) over all trials and for each subgroup of trials targeting one of 7 mechanisms (IL-6, TNF-α, IL-12/23, CD20, COX2, BLγS, p38/MAPK14). Patients in the high depressive stratum showed modest but significant effects on core depressive symptoms (SMD = 0.29, 95% CI [0.12-0.45]) and related SF-36 measures of mental health and vitality. Anti-IL-6 antibodies (SMD = 0.8, 95% CI [0.20-1.41]) and an anti-IL-12/23 antibody (SMD = 0.48, 95% CI [0.26-0.70]) had larger effects on depressive symptoms than other drug classes. Adjustments for physical health outcome marginally attenuated the average treatment effect on depressive symptoms (SMD = 0.20, 95% CI: 0.06-0.35), but more strongly attenuated effects on mental health and vitality. Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment. Novel immune-therapeutics can produce antidepressant effects in depressed patients with primary inflammatory disorders that are not entirely explained by treatment-related changes in physical health.",2020,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"['depressed patients with primary inflammatory disorders', 'for one of nine disorders (N\u2009=\u200910,743 participants']","['Placebo', 'placebo', 'immunomodulatory drugs', 'Janssen or GlaxoSmithKline']","['depressive symptoms', 'Anti-IL-6 antibodies', 'mental health and vitality', 'core depressive symptoms', 'related SF-36 measures of mental health and vitality', 'Core depressive symptoms (low mood, anhedonia', 'Hospital Anxiety and Depression Scale (HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.398153,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"[{'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Wittenberg', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA. gwittenb@its.jnj.com.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Stylianou', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Jagannatha', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hsu', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Curran', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0471-8']
2548,31422028,Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis.,"BACKGROUND
Phase 3 clinical data has shown higher proportions of patients with objective response, longer response duration, and longer overall survival with nivolumab versus docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC). We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival.
METHODS
We pooled data from four clinical studies of nivolumab in patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003) to evaluate survival outcomes. Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included. Comparisons of nivolumab versus docetaxel included all randomised patients from the phase 3 CheckMate 017 and 057 studies. We did landmark analyses by response status at 6 months to determine post-landmark survival outcomes. We excluded patients who did not have a radiographic tumour assessment at 6 months. Safety analyses included all patients who received at least one dose of nivolumab.
FINDINGS
Across all four studies, 4-year overall survival with nivolumab was 14% (95% CI 11-17) for all patients (n=664), 19% (15-24) for those with at least 1% PD-L1 expression, and 11% (7-16) for those with less than 1% PD-L1 expression. In CheckMate 017 and 057, 4-year overall survival was 14% (95% CI 11-18) in patients treated with nivolumab, compared with 5% (3-7) in patients treated with docetaxel. Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52 (0·37-0·71) for nivolumab and 0·80 (0·61-1·04) for docetaxel. Long-term data did not show any new safety signals.
INTERPRETATION
Patients with advanced NSCLC treated with nivolumab achieved a greater duration of response compared with patients treated with docetaxel, which was associated with a long-term survival advantage.
FUNDING
Bristol-Myers Squibb.",2019,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","['patients with previously treated advanced non-small-cell lung cancer (NSCLC', 'patients from the phase 3 CheckMate 017 and 057 studies', 'patients who did not have a radiographic tumour assessment at 6 months', 'patients with previously treated advanced non-small-cell lung cancer', 'patients who received at least one dose of nivolumab', 'patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003', 'Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included']","['docetaxel', 'nivolumab versus docetaxel', 'nivolumab or docetaxel', 'nivolumab']","['survival outcomes', 'duration of response', '4-year overall survival with nivolumab', '4-year overall survival', 'Survival subsequent to response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]",664.0,0.50406,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","[{'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA. Electronic address: scott.antonia@duke.edu.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Castro Carpeño', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pluzanski', 'Affiliation': 'Klinika Nowotworow Pluca i Klatki Piersiowej, Centrum Onkologii-Instytut Im Marii Sklodowskiej-Curie, Warsaw, Poland.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Burgio', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Garassino', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Laura Q M', 'Initials': 'LQM', 'LastName': 'Chow', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gettinger', 'Affiliation': 'Yale Cancer Center, New Haven, CT, USA.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Crinò', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Institut Gustave Roussy, Department of Medical Oncology, Thoracic Group, Villejuif, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Butts', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Drilon', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wojcik-Tomaszewska', 'Affiliation': 'Wojewodzkie Centrum Onkologii, Gdańsk, Poland.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Otterson', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Penrod', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30407-3']
2549,31229634,Oxytocin reduces top-down control of attention by increasing bottom-up attention allocation to social but not non-social stimuli - A randomized controlled trial.,"The neuropeptide oxytocin (OXT) may facilitate attention to social stimuli by influencing early stage bottom-up processing although findings in relation to different emotional expressions are inconsistent and its influence on top-down cognitive processing mechanisms unclear. In the current double-blind placebo (PLC) controlled between-subject design study we therefore recruited 71 male subjects (OXT = 34, PLC = 37) to investigate the effects of intranasal OXT (24IU) on both bottom-up attention allocation and top-down attention inhibition using a prosaccade and antisaccade paradigm incorporating social (neutral, happy, fearful, sad, angry faces) and non-social (oval shape) visual stimuli with concurrent eye movement acquisition. Results revealed a marginal significant interaction effect between treatment, condition and task (p = 0.054), with Bonferroni-corrected post-hoc tests indicating that OXT specifically increased antisaccade errors for social stimuli (ps < 0.04, effect sizes 0.46-0.88), but not non-social stimuli. Antisaccades are under volitional control and therefore this may indicate that OXT treatment reduced top-down inhibition. However, the overall findings are consistent with OXT acting to reduce top-down control of attention as a result of increasing bottom-up early attentional processing of social, but not non-social, stimuli in situations where the two systems are in potential conflict. Marked deficits in bottom-up attention allocation to social stimuli have been reported in autism spectrum disorder, within this context OXT may have the potential to increase early attention allocation towards social cues.",2019,"Results revealed a marginal significant interaction effect between treatment, condition and task (p = 0.054), with Bonferroni-corrected post-hoc tests indicating that OXT specifically increased antisaccade errors for social stimuli (ps < 0.04, effect sizes 0.46-0.88), but not non-social stimuli.","['71 male subjects (OXT\u202f=\u202f34, PLC\u202f=\u202f37']","['OXT', 'Oxytocin', 'intranasal OXT (24IU) on both bottom-up attention allocation and top-down attention inhibition using a prosaccade and antisaccade paradigm incorporating social (neutral, happy, fearful, sad, angry faces) and non-social (oval shape) visual stimuli with concurrent eye movement acquisition', 'neuropeptide oxytocin (OXT', 'placebo (PLC']",['antisaccade errors for social stimuli'],"[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",71.0,0.0718827,"Results revealed a marginal significant interaction effect between treatment, condition and task (p = 0.054), with Bonferroni-corrected post-hoc tests indicating that OXT specifically increased antisaccade errors for social stimuli (ps < 0.04, effect sizes 0.46-0.88), but not non-social stimuli.","[{'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610054, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610054, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610054, China.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610054, China. Electronic address: k.kendrick.uestc@gmail.com.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610054, China. Electronic address: ben_becker@gmx.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.06.004']
2550,31422923,Ten-year outcomes from a randomised comparison of zotarolimus-eluting and sirolimus-eluting stents: the SORT OUT III study.,,2019,,[],['zotarolimus-eluting and sirolimus-eluting stents'],[],[],"[{'cui': 'C1700035', 'cui_str': 'zotarilumus'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]",[],,0.01768,,"[{'ForeName': 'Manan', 'Initials': 'M', 'LastName': 'Pareek', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Madsen', 'Affiliation': ''}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Warnakula Olesen', 'Affiliation': ''}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'Okkels Jensen', 'Affiliation': ''}, {'ForeName': 'Evald', 'Initials': 'E', 'LastName': 'Høj Christiansen', 'Affiliation': ''}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Dalby Kristensen', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Flensted Lassen', 'Affiliation': ''}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Thuesen', 'Affiliation': ''}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00503']
2551,32495498,"Maternal knowledge in complementary feeding following Baby Friendly Community Initiative in Koibatek, Kenya.","The Kenyan Ministry of Health has developed a National Strategy on Infant and Young Child Feeding with the goal of improving feeding practices for infants and children. In order to promote appropriate infant feeding, the government has explored implementation of the Baby Friendly Community Initiative (BFCI). This study assessed maternal knowledge of attributes of complementary feeding following implementation of BFCI in Koibatek, Kenya. A randomized control study composed of 270 mother-infant pairs previously enrolled in a BFCI programme in Koibatek was conducted. The study found that a significantly greater number of mothers in the intervention group were more knowledgeable about proper breastfeeding and complementary feeding aspects compared with controls (P ≤ 0.001). About half (53%) of mothers in the intervention group had high knowledge scores in comparison with 20% of mothers in the control group. When the relationship between mothers' knowledge and complementary feeding practices (minimum meal frequency, minimum dietary diversity and minimum acceptable diet) was assessed, significant associations were observed (P = 0.010, P ≤ 0.001 and P ≤ 0.001, respectively). The odds of having a high knowledge score regarding complementary feeding practices were significantly higher for the intervention group compared with the control group (odds ratio [OR]: 25.98, 95% confidence interval [CI] 13.62-49.55, P ≤ 0.001). The BFCI intervention effectively improved mothers' knowledge on complementary feeding and correlated with improved feeding practices.",2020,"The odds of having a high knowledge score regarding complementary feeding practices were significantly higher for the intervention group compared with the control group (odds ratio [OR]: 25.98, 95% confidence interval [CI] 13.62-49.55, P ≤ 0.001).","['infants and children', 'Baby Friendly Community Initiative in Koibatek, Kenya', '270 mother-infant pairs previously enrolled in a BFCI programme in Koibatek was conducted']",[],"['knowledgeable about proper breastfeeding and complementary feeding aspects', 'odds of having a high knowledge score regarding complementary feeding practices', 'Maternal knowledge', 'high knowledge scores', ""mothers' knowledge on complementary feeding and correlated with improved feeding practices""]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],"[{'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0368679,"The odds of having a high knowledge score regarding complementary feeding practices were significantly higher for the intervention group compared with the control group (odds ratio [OR]: 25.98, 95% confidence interval [CI] 13.62-49.55, P ≤ 0.001).","[{'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Maingi', 'Affiliation': 'School of Nutritional Sciences, The Hebrew University of Jerusalem and The International School of Agricultural Sciences, Rehovot, Israel.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kimiywe', 'Affiliation': 'School of Public Health and Applied Human Sciences, Department of Food Nutrition and Dietetics, Kenyatta University, Nairobi, Kenya.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Iron-Segev', 'Affiliation': 'School of Nutritional Sciences, The Hebrew University of Jerusalem and The International School of Agricultural Sciences, Rehovot, Israel.'}]",Maternal & child nutrition,['10.1111/mcn.13027']
2552,32495381,Randomised controlled trial of multi-modular motion-assisted memory desensitisation and reconsolidation (3MDR) for male military veterans with treatment-resistant post-traumatic stress disorder.,"OBJECTIVE
To explore the potential efficacy of multi-modular motion-assisted memory desensitisation and reprocessing (3MDR) in British military veterans with treatment-resistant, service-related PTSD.
METHODS
Exploratory single-blind, randomised, parallel arm, cross-over controlled trial with nested process evaluation to assess fidelity, adherence and factors that influence outcome.
RESULTS
42 participants (all male) were randomised with 83% retention at 12 weeks and 86% at 26 weeks. The difference in mean Clinician Administered PTSD Scale for DSM-5 scores between the immediate and delayed 3MDR arms was -9.38 (95% CI -17.33 to -1.44, p = 0.021) at 12 weeks and -3.59 (-14.39 to 7.20, p= 0.513) at 26 weeks when both groups had received 3MDR. The likely effect size of 3MDR was found to be 0.65. Improvements were maintained at 26 week follow-up. 3MDR was found to be acceptable to most, but not all, participants. Several factors that may impact efficacy and acceptability of 3MDR were identified.
CONCLUSION
3MDR is a promising new intervention for treatment-resistant PTSD with emerging evidence of effect.",2020,"(-14.39 to 7.20, p= 0.513) at 26 weeks when both groups had received 3MDR.","['male military veterans with treatment-resistant post-traumatic stress disorder', 'British military veterans with treatment-resistant, service-related PTSD', '42 participants (all male']","['multi-modular motion-assisted memory desensitisation and reconsolidation (3MDR', 'multi-modular motion-assisted memory desensitisation and reprocessing (3MDR', '3MDR']","['3MDR', 'mean Clinician Administered PTSD Scale for DSM-5 scores']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.133104,"(-14.39 to 7.20, p= 0.513) at 26 weeks when both groups had received 3MDR.","[{'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Bisson', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'van Deursen', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Hannigan', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kitchiner', 'Affiliation': ""Veterans' NHS Wales, Cardiff and Vale University Health Board, United Kingdom of Great Britain and Northern Ireland.""}, {'ForeName': 'Kali', 'Initials': 'K', 'LastName': 'Barawi', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'Mental Health Research Nurse, Cardiff and Vale University Health Board, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Leigh R', 'Initials': 'LR', 'LastName': 'Abbott', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'van Gelderen', 'Affiliation': 'Psychologist and Researcher, ARQ Centrum 45, Diemen, Netherlands.'}, {'ForeName': 'Mirjam J', 'Initials': 'MJ', 'LastName': 'Nijdam', 'Affiliation': ""Licensed Psychologist and Head of Research Theme, ARQ Centrum '45, ARQ National Psychotrauma Centre, Diemen, Netherlands.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vermetten', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13200']
2553,32495329,[Effects of the Otago Exercise Program on Lower Extremity Strength in Residents of a Long-Term Care Institution].,"BACKGROUND
Falls are a very common problem in older adults. Improving lower extremity muscle strength is the primary objective of fall-prevention programs.
PURPOSE
The aim of the study was to evaluate the effects of the Otago Exercise Program (OEP) on the lower extremity muscle strength of residents living in a long-term care institution.
METHODS
In this repeated measurement study, participants were allocated into either the experimental group (EG) or the control group (CG). All of the participants maintained normal activities, and EG participants were additionally enrolled in a 6-month group OEP led by a physiotherapist. The OEP, comprising warm-up exercises, strength training, balance training, and walking training, requires about 45 minutes per session, 3 times a week. A total of 78 OEP sessions were performed during the 6-month intervention. A 30-Second Sit-to-Stand Test and lower extremity muscle strength measurements were performed at baseline, after 3 months, and after 6 months.
RESULTS
The twenty participants in this study had a mean age over 80 years and were recruited from a long-term care institution in southern Taiwan. There were ten participants in each group, and the mean total OEP session attendance for EG participants was 92.8%. Although the EG had lower extremity muscle strength than the CG at baseline, the EG had achieved significant improvements in the muscle strength values for the knee extensor, knee flexor, ankle plantar flexors, and dorsiflexors after 6 months (group x time interaction, p < .05). In addition, the results of the 30-second sit-to-stand test for the EG were poor at baseline and significantly better after 6 months, while the results for the CG worsened between baseline and 6 months.
CONCLUSIONS / IMPLICATIONS FOR PRACTICE
The results of this study support that participating in a group-based OEP three times per week over 6 months effectively improves lower extremity muscle strength in older adults. Therefore, OEP should be incorporated into fall-prevention programs organized in long-term care institutions.",2020,"Although the EG had lower extremity muscle strength than the CG at baseline, the EG had achieved significant improvements in the muscle strength values for the knee extensor, knee flexor, ankle plantar flexors, and dorsiflexors after 6 months (group x time interaction, p < .05).","['Residents of a Long-Term Care Institution', 'older adults', 'participants maintained normal activities, and EG participants were additionally enrolled in a 6-month group OEP led by a physiotherapist', 'twenty participants in this study had a mean age over 80 years and were recruited from a long-term care institution in southern Taiwan', 'residents living in a long-term care institution']","['Otago Exercise Program (OEP', 'strength training, balance training, and walking training', 'Otago Exercise Program']","['extremity muscle strength', 'knee flexor, ankle plantar flexors, and dorsiflexors', 'mean total OEP session attendance', 'muscle strength values', 'Lower Extremity Strength']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001795', 'cui_str': 'Oldest Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.0147171,"Although the EG had lower extremity muscle strength than the CG at baseline, the EG had achieved significant improvements in the muscle strength values for the knee extensor, knee flexor, ankle plantar flexors, and dorsiflexors after 6 months (group x time interaction, p < .05).","[{'ForeName': 'Yung-Chi', 'Initials': 'YC', 'LastName': 'Cheng', 'Affiliation': 'EMBA, PT, Leader, Department of Rehabilitation, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Taiwan, ROC.'}, {'ForeName': 'Yen-Chi', 'Initials': 'YC', 'LastName': 'Liao', 'Affiliation': 'MSN, RN, Director, Department of Nursing, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Taiwan, ROC.'}, {'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Hsieh', 'Affiliation': 'MSN, RN, Researcher, Department of Nursing, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Taiwan, ROC.'}]",Hu li za zhi The journal of nursing,['10.6224/JN.202006_67(3).07']
2554,32438267,Effect of exercise on knee joint contact forces in people following medial partial meniscectomy: A secondary analysis of a randomised controlled trial.,"BACKGROUND
Arthroscopic partial meniscectomy may cause knee osteoarthritis, which may be related to altered joint loading. Previous research has failed to demonstrate that exercise can reduce medial compartment knee loads following meniscectomy but has not considered muscular loading in their estimates.
RESEARCH QUESTION
What is the effect of exercise compared to no intervention on peak medial tibiofemoral joint contact force during walking using an electromyogram-driven neuromusculoskeletal model, following medial arthroscopic partial meniscectomy?
METHODS
This is a secondary analysis of a randomized controlled trial (RCT). 41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months, were randomly allocated to either a 12-week, home-based, physiotherapist-guided exercise program or to no exercise (control group). Three-dimensional lower-body motion, ground reaction forces, and surface electromyograms from eight lower-limb muscles were acquired during self-selected normal- and fast-paced walking at baseline and follow-up. An electromyogram-driven neuromusculoskeletal model estimated medial compartment contact forces (body weight). Linear regression models evaluated between-group differences (mean difference (95% CI)).
RESULTS
There were no significant between-group differences in the change (follow-up minus baseline) in first peak medial contact force during self-selected normal- or fast-paced walking (0.07 (-0.08 to 0.23), P = 0.34 and 0.01 (-0.19 to 0.22), P = 0.89 respectively). No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02 (-0.17 to 0.22), P = 0.81 respectively). At the individual level, variability was observed for changes in first (range -26.2% to +31.7%) and second (range -46.5% to +59.9%) peak tibiofemoral contact force.
SIGNIFICANCE
This is the first study to apply electromyogram-driven neuromusculoskeletal modelling to an exercise intervention in a RCT. While our results suggest that a 12-week exercise program does not alter peak medial knee loads after meniscectomy, within-participant variability suggests individual-specific muscle activation patterns that warrant further investigation.",2020,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","['41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months', 'people following medial partial meniscectomy']","['exercise intervention', 'physiotherapist-guided exercise program or to no exercise (control group', 'exercise']","['knee joint contact forces', 'peak medial knee loads', 'change in second peak medial contact force during normal- or fast-paced walking', 'peak tibiofemoral contact force', 'peak medial contact force during self-selected normal- or fast-paced walking']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",41.0,0.0930649,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Starkey', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Gavin K', 'Initials': 'GK', 'LastName': 'Lenton', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Saxby', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wrigley', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lloyd', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia. Electronic address: halm@unimelb.edu.au.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.025']
2555,32438481,Intravesical prostatic protrusion does not compromise the therapeutic effects of Mirabegron in male patients with overactive bladder.,"AIMS
Intravesical prostatic protrusion (IPP) is associated with the degree of benign prostatic obstruction. We evaluated the effects of Mirabegron, a selective β3 adrenoceptor agonist, on overactive bladder (OAB) in male patients with different degrees of IPP.
METHODS
About 185 male patients ≥40 years with lower urinary tract symptoms were recruited from a tertiary referral center. OAB was defined by the overactive bladder symptom score (OABSS) urgency score of ≥2 and sum score of ≥3. IPP was measured in the midsagittal section using transrectal ultrasound and patients were divided into IPP ≤5 mm and IPP >5 mm groups. Outcomes were assessed at the baseline, 4, and 12 weeks.
RESULTS
About 104 patients (56.2%) were diagnosed with OAB and received Mirabegron (50 mg) daily use. Both IPP groups (≤5 and >5 mm) had similar baseline OABSS and International Prostate Symptom Scores (IPSS). Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP ≤5 mm -27.4% and IPP >5 mm -19.7% (P = .419) and IPSS: -32% and -22.5% (P = .202), respectively. Urgency, urge incontinence, and nocturia sub-scores were decreased in both groups, -26.3% and -27.4% (P = .690), 53.3% and 46.2% (P = .916), and 20.8% and 15.4% (P = .958). Effects were maintained at 12 weeks. We found no significant improvement in the frequency sub-score in either group. One patient stopped medication because of intolerable hypertension. Most frequent adverse event was increased residual urine (≥50 mL higher than baseline), IPP ≤5 mm 9.2% and IPP >5 mm 5.1% (P = .707), but no case had acute urinary retention.
CONCLUSIONS
Mirabegron is an effective drug to treat male OAB regardless of IPP grade.",2020,"Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP≤5mm -27.4% and IPP>5mm -19.7% (p=0.419) and IPSS:","['185 male patients ≥ 40 years with lower urinary tract symptoms (LUTS) were recruited from a tertiary referral center', '104 patients (56.2%) were diagnosed with OAB and received', 'male patients with overactive bladder', 'male patients with different degrees of IPP']","['Intravesical prostatic protrusion (IPP', 'Intravesical Prostatic Protrusion', 'Mirabegron']","['IPP', 'OAB', 'Urgency, urge incontinence and nocturia sub-scores', 'frequency sub-score', 'overactive bladder (OAB', 'OAB symptom score urgency score', 'IPSS', 'baseline OAB Symptom Scores and International Prostate Symptom Scores (IPSS']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",185.0,0.0757977,"Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP≤5mm -27.4% and IPP>5mm -19.7% (p=0.419) and IPSS:","[{'ForeName': 'Yuan C', 'Initials': 'YC', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Hung J', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei C', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Chien H', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Yao C', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}]",International journal of clinical practice,['10.1111/ijcp.13537']
2556,32438479,Long-term results of a randomized study comparing parathyroidectomy with cinacalcet for treating tertiary hyperparathyroidism.,"Tertiary hyperparathyroidism is a common cause of hypercalcemia after kidney transplantation (KT) and has been associated with renal dysfunction, bone mineral density loss, and increased risk of fracture and cardiovascular events. In a previous 12-month clinical trial, we demonstrated that subtotal parathyroidectomy was more effective than cinacalcet for controlling hypercalcemia. In the current study, we retrospectively evaluate whether this effect is maintained after 5 years of follow-up. In total, 24 patients had data available at 5 years, 13 in the cinacalcet group and 11 in the parathyroidectomy group. At 5 years, 7 of 11 patients (64%) in the parathyroidectomy group and 6 of 13 patients (46%) in the cinacalcet group (P = .44) showed normocalcemia. However, recurrence of hypercalcemia was only observed in the cinacalcet group (P = .016). Subtotal parathyroidectomy retained a greater reduction in intact parathyroid hormone (iPTH) compared with cinacalcet group. No differences were observed in kidney function and incidence of fragility fractures between both groups. Cinacalcet was discontinued in 5 out of 13 patients. In conclusion, in kidney transplant patients with tertiary hyperparathyroidism recurrence of hypercalcemia after 5-year follow-up is more frequent in cinacalcet than after subtotal parathyroidectomy.",2020,Subtotal parathyroidectomy retained a greater reduction of intact parathyroid hormone (iPTH) compared with cinacalcet group.,"['hypercalcemia after kidney transplantation (KT', 'kidney transplant patients with tertiary hyperparathyroidism recurrence', '24 patients had data available at 5 years, 13 in the cinacalcet group and 11 in the parathyroidectomy group']","['parathyroidectomy', 'subtotal parathyroidectomy', 'Subtotal parathyroidectomy']","['recurrence of hypercalcemia', 'intact parathyroid hormone (iPTH', 'hypercalcemia', 'kidney function and incidence of fragility fractures', 'normocalcemia']","[{'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271858', 'cui_str': 'Tertiary hyperparathyroidism'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1337242', 'cui_str': 'cinacalcet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}]","[{'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0193697', 'cui_str': 'Subtotal parathyroidectomy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}]",24.0,0.0524296,Subtotal parathyroidectomy retained a greater reduction of intact parathyroid hormone (iPTH) compared with cinacalcet group.,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Moreno', 'Affiliation': ""Department of Surgery, Hospital Universitari de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Coloma', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'José V', 'Initials': 'JV', 'LastName': 'Torregrosa', 'Affiliation': 'Nephrology and Renal Transplant Service, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Montero', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Francos', 'Affiliation': ""Department of Surgery, Hospital Universitari de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Codina', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Manonelles', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Bestard', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'García-Barrasa', 'Affiliation': ""Department of Surgery, Hospital Universitari de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Melilli', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Cruzado', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Clinical transplantation,['10.1111/ctr.13988']
2557,32438316,Using simulation to teach undergraduate nursing and midwifery students research design.,"Whilst it is widely accepted that the ability to critique, interpret and integrate research is an integral part of the evidence-based practice of nursing and midwifery, teaching such skills to undergraduate students is equally recognised as challenging. From a student's perspective the theoretical aspects, concepts and language of research design may seem far removed from the imperative of developing skills and gaining clinical experience. Simulation has been widely demonstrated as an effective pedagogical approach to engage students in learning and developing practical skills. The 'hands-on' approach provides a cognitive link between theory and practice that is immediately relevant to the student. Simulation training has also been used in other areas of healthcare such as communication and ethics. However, the use of simulation to demonstrate the theoretical and practical aspects of research design to midwifery and nursing students has not been explored. This paper describes a novel approach to teaching undergraduate students fundamental concepts of randomised controlled trial design through their participation in a simulated research trial. Students experienced aspects such as consent, randomisation, intervention, data collection, analysis and interpretation. Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.",2020,"Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.",[],['Simulation training'],[],[],"[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}]",[],,0.0187677,"Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.","[{'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Chamberlain Building University of Queensland, St Lucia, 4072, Queensland, Australia. Electronic address: nigel.lee@uq.edu.au.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Peacock', 'Affiliation': 'Chamberlain Building University of Queensland, St Lucia, 4072, Queensland, Australia. Electronic address: a.peacock2@uq.edu.au.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102804']
2558,31416827,Prednisolone Versus Dexamethasone for Croup: a Randomized Controlled Trial.,"OBJECTIVES
The use of either prednisolone or low-dose dexamethasone in the treatment of childhood croup lacks a rigorous evidence base despite widespread use. In this study, we compare dexamethasone at 0.6 mg/kg with both low-dose dexamethasone at 0.15 mg/kg and prednisolone at 1 mg/kg.
METHODS
Prospective, double-blind, noninferiority randomized controlled trial based in 1 tertiary pediatric emergency department and 1 urban district emergency department in Perth, Western Australia. Inclusions were age >6 months, maximum weight 20 kg, contactable by telephone, and English-speaking caregivers. Exclusion criteria were known prednisolone or dexamethasone allergy, immunosuppressive disease or treatment, steroid therapy or enrollment in the study within the previous 14 days, and a high clinical suspicion of an alternative diagnosis. A total of 1252 participants were enrolled and randomly assigned to receive dexamethasone (0.6 mg/kg; n = 410), low-dose dexamethasone (0.15 mg/kg; n = 410), or prednisolone (1 mg/kg; n = 411). Primary outcome measures included Westley Croup Score 1-hour after treatment and unscheduled medical re-attendance during the 7 days after treatment.
RESULTS
Mean Westley Croup Score at baseline was 1.4 for dexamethasone, 1.5 for low-dose dexamethasone, and 1.5 for prednisolone. Adjusted difference in scores at 1 hour, compared with dexamethasone, was 0.03 (95% confidence interval -0.09 to 0.15) for low-dose dexamethasone and 0.05 (95% confidence interval -0.07 to 0.17) for prednisolone. Re-attendance rates were 17.8% for dexamethasone, 19.5% for low-dose dexamethasone, and 21.7% for prednisolone (not significant [ P = .59 and .19]).
CONCLUSIONS
Noninferiority was demonstrated for both low-dose dexamethasone and prednisolone. The type of oral steroid seems to have no clinically significant impact on efficacy, both acutely and during the week after treatment.",2019,"Adjusted difference in scores at 1 hour, compared with dexamethasone, was 0.03","['A total of 1252 participants', 'Croup', '1 tertiary pediatric emergency department and 1 urban district emergency department in Perth, Western Australia']","['Prednisolone Versus Dexamethasone', 'prednisolone', 'dexamethasone', 'dexamethasone and prednisolone', 'low-dose dexamethasone', 'prednisolone or low-dose dexamethasone', 'prednisolone or dexamethasone allergy, immunosuppressive disease or treatment, steroid therapy']","['Westley Croup Score 1-hour after treatment and unscheduled medical re-attendance during the 7 days after treatment', 'prednisolone. Re-attendance rates']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010380', 'cui_str': 'Croup'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0571611', 'cui_str': 'Dexamethasone allergy (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}]","[{'cui': 'C4720898', 'cui_str': 'Westley croup score'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]",1252.0,0.663817,"Adjusted difference in scores at 1 hour, compared with dexamethasone, was 0.03","[{'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'Parker', 'Affiliation': ""Perth Children's Hospital, Perth, Australia; colin.parker@health.wa.gov.au.""}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cooper', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Australia.'}]",Pediatrics,['10.1542/peds.2018-3772']
2559,31418811,Effect of Physical Activity Coaching on Acute Care and Survival Among Patients With Chronic Obstructive Pulmonary Disease: A Pragmatic Randomized Clinical Trial.,"Importance
While observational studies show that physical inactivity is associated with worse outcomes in chronic obstructive pulmonary disease (COPD), there are no population-based trials to date testing the effectiveness of physical activity (PA) interventions to reduce acute care use or improve survival.
Objective
To evaluate the long-term effectiveness of a community-based PA coaching intervention in patients with COPD.
Design, Setting, and Participants
Pragmatic randomized clinical trial with preconsent randomization to the 12-month Walk On! (WO) intervention or standard care (SC). Enrollment occurred from July 1, 2015, to July 31, 2017; follow-up ended in July 2018. The setting was Kaiser Permanente Southern California sites. Participants were patients 40 years or older who had any COPD-related acute care use in the previous 12 months; only patients assigned to WO were approached for consent to participate in intervention activities.
Interventions
The WO intervention included collaborative monitoring of PA step counts, semiautomated step goal recommendations, individualized reinforcement, and peer/family support. Standard COPD care could include referrals to pulmonary rehabilitation.
Main Outcomes and Measures
The primary outcome was a composite binary measure of all-cause hospitalizations, observation stays, emergency department visits, and death using adjusted logistic regression in the 12 months after randomization. Secondary outcomes included self-reported PA, COPD-related acute care use, symptoms, quality of life, and cardiometabolic markers.
Results
All 2707 eligible patients (baseline mean [SD] age, 72 [10] years; 53.7% female; 74.3% of white race/ethnicity; and baseline mean [SD] percent forced expiratory volume in the first second of expiration predicted, 61.0 [22.5]) were randomly assigned to WO (n = 1358) or SC (n = 1349). The intent-to-treat analysis showed no differences between WO and SC on the primary all-cause composite outcome (odds ratio [OR], 1.09; 95% CI, 0.92-1.28; P = .33) or in the individual outcomes. Prespecified, as-treated analyses compared outcomes between all SC and 321 WO patients who participated in any intervention activities (23.6% [321 of 1358] uptake). The as-treated, propensity score-weighted model showed nonsignificant positive estimates in favor of WO participants compared with SC on all-cause hospitalizations (OR, 0.84; 95% CI, 0.65-1.10; P = .21) and death (OR, 0.62; 95% CI, 0.35-1.11; P = .11). More WO participants reported engaging in PA compared with SC (47.4% [152 of 321] vs 30.7% [414 of 1349]; P < .001) and had improvements in the Patient-Reported Outcomes Measurement Information System 10 physical health domain at 6 months. There were no group differences in other secondary outcomes.
Conclusions and Relevance
Participation in a PA coaching program by patients with a history of COPD exacerbations was insufficient to effect improvements in acute care use or survival in the primary analysis.
Trial Registration
ClinicalTrials.gov identifier: NCT02478359.",2019,"The intent-to-treat analysis showed no differences between WO and SC on the primary all-cause composite outcome (odds ratio [OR], 1.09; 95% CI, 0.92-1.28; P = .33) or in the individual outcomes.","['patients with COPD', 'chronic obstructive pulmonary disease (COPD', '2707 eligible patients (baseline mean [SD] age, 72 [10] years; 53.7% female; 74.3% of white race/ethnicity; and baseline mean [SD] percent forced expiratory volume in the first second of expiration predicted, 61.0 [22.5', 'patients with a history of COPD exacerbations', 'Participants were patients 40 years or older who had any COPD-related acute care use in the previous 12 months; only patients assigned to WO were approached for consent to participate in intervention activities', 'Patients With Chronic Obstructive Pulmonary Disease']","['WO) intervention or standard care (SC', 'Physical Activity Coaching', 'PA coaching program', 'physical activity (PA) interventions', 'community-based PA coaching intervention']","['death', 'Acute Care and Survival', 'self-reported PA, COPD-related acute care use, symptoms, quality of life, and cardiometabolic markers', 'composite binary measure of all-cause hospitalizations, observation stays, emergency department visits, and death using adjusted logistic regression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}]",2707.0,0.159903,"The intent-to-treat analysis showed no differences between WO and SC on the primary all-cause composite outcome (odds ratio [OR], 1.09; 95% CI, 0.92-1.28; P = .33) or in the individual outcomes.","[{'ForeName': 'Huong Q', 'Initials': 'HQ', 'LastName': 'Nguyen', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'In-Lu Amy', 'Initials': 'IA', 'LastName': 'Liu', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Vincent S', 'Initials': 'VS', 'LastName': 'Fan', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Gould', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Smita A', 'Initials': 'SA', 'LastName': 'Desai', 'Affiliation': 'Kaiser Permanente Southern California, San Diego.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Towner', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Yuen', 'Affiliation': 'Kaiser Permanente Southern California, Orange County, Anaheim.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Stacy J', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Anny H', 'Initials': 'AH', 'LastName': 'Xiang', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9657']
2560,32495663,Multiple-dose versus single-dose gonadotropin-releasing hormone agonist after first in vitro fertilization failure associated with luteal phase deficiency: A randomized controlled trial.,"OBJECTIVE
To evaluate the efficacy and safety of multiple- versus single-dose gonadotropin-releasing hormone agonist (GnRH-a) addition to luteal phase support (LPS), in patients with a first in vitro fertilization (IVF) failure associated with luteal phase deficiency (LPD).
METHODS
Eighty patients with a first IVF failure associated with LPD were randomly assigned into single-dose and multiple-dose GnRH-a groups. In the second IVF attempt, patients in the single-dose group were given standard LPS plus a single dose of GnRH-a 6 days after oocyte retrieval. Patients in the multiple-dose group received standard LPS plus 14 daily injections of GnRH-a. Children conceived were followed up for 2 years.
RESULTS
Pregnancy (67.5% vs. 42.5%), clinical pregnancy (50.0% vs. 22.5%), and live birth rates (42.5% vs. 20.0%) were significantly higher in the multiple-dose versus single-dose GnRH-a group. Patients in the multiple-dose GnRH-a group had significantly higher progesterone levels 14 days after oocyte recovery (35.9 vs. 21.4 ng/mL). No significant difference existed in the status at birth or developmental and behavior assessments of 2-year-old children conceived in both groups.
CONCLUSIONS
Daily addition of GnRH-a to standard LPS can achieve better pregnancy outcomes with a sustained safety profile in patients with a first IVF failure associated with LPD.",2020,"No significant difference existed in the status at birth or developmental and behavior assessments of 2-year-old children conceived in both groups.
","['patients with a first in vitro fertilization (IVF) failure associated with luteal phase deficiency (LPD', 'vitro fertilization failure associated with luteal phase deficiency', 'patients with a first IVF failure associated with LPD', 'Eighty patients with a first IVF failure associated with LPD']","['multiple- versus single-dose gonadotropin-releasing hormone agonist (GnRH-a) addition to luteal phase support (LPS', 'standard LPS plus 14 daily injections of GnRH-a', 'standard LPS', 'Multiple-dose versus single-dose gonadotropin-releasing hormone agonist']","['live birth rates', 'status at birth or developmental and behavior assessments of 2-year-old children', 'efficacy and safety', 'progesterone levels', 'clinical pregnancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0404576', 'cui_str': 'Luteal phase defect'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",80.0,0.0718243,"No significant difference existed in the status at birth or developmental and behavior assessments of 2-year-old children conceived in both groups.
","[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Qu', 'Affiliation': 'Medical Center for Human Reproduction, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Medical Center for Human Reproduction, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520926026']
2561,30612246,Randomized clinical trial of class II restoration in permanent teeth comparing ART with composite resin after 12 months.,"OBJECTIVE
This study evaluated the effectiveness of class II restorations, in permanent teeth, through the ART technique in comparison to composite resin.
MATERIALS AND METHODS
Participants (154), aged 8 to 19 years, with good general health, with class II cavities in permanent teeth, and without pulp involvement and tooth pain were included in this parallel and randomized clinical trial. The Ethics Committee approval number was CAAE: 24012913.0.1001.5417. Seventy-seven restorations were made with each restorative material (Equia Fil-GC Corporation and Z350-3M). Evaluations occurred at 6 and 12 months by the criteria of ART and the USPHS modified. Data were analyzed by Mann-Whitney, chi-square, Fisher's exact, chi-square tests with linear trend and logistic regression by enter method (p < 0.050). The Kaplan-Meier test evaluated the survival rates of the restorations. The log-rank test compared the survival curves.
RESULTS
Regardless of the evaluation criteria used, the success rates of ART restorations were 98.7% (6 months) and 95.8% (12 months) and for composite resins were 100% (6 months) and 98.7% (12 months), with no statistical difference of restoration groups (p > 0.050). Survival rates for restorations, regardless of the evaluation criteria used, are the same as the success rates, with the exception of ART restorations at 12 months of follow-up (94.8%).
CONCLUSION
No differences in the success rates of class II restorations of ART compared to resin composite, in permanent teeth, were observed after 12 months.
CLINIC SIGNIFICANT
HVGIC can safely be used to restore proximal cavities in permanent teeth up to 12 months.",2019,"No differences in the success rates of class II restorations of ART compared to resin composite, in permanent teeth, were observed after 12 months.
","['Participants (154), aged 8 to 19\xa0years, with good general health, with class II cavities in permanent teeth, and without pulp involvement and tooth pain']",[],"['composite resins', 'survival rates', 'success rates of ART restorations', 'Survival rates', 'success rates of class II restorations of ART']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0040460', 'cui_str': 'Odontalgia'}]",[],"[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}]",77.0,0.110928,"No differences in the success rates of class II restorations of ART compared to resin composite, in permanent teeth, were observed after 12 months.
","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Menezes-Silva', 'Affiliation': 'Department of Dental Materials, Endodontics and Operative Dentistry, Bauru School of Dentistry, Bauru, Brazil. rafa18ms@hotmail.com.'}, {'ForeName': 'S R M', 'Initials': 'SRM', 'LastName': 'Velasco', 'Affiliation': 'Public Health Faculty, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Bastos', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, Bauru, Brazil.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Molina', 'Affiliation': 'Department of Dental Materials, School of Dentistry, National University of Córdoba, Córdoba, Argentina.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Honório', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, Bauru, Brazil.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Frencken', 'Affiliation': 'Department of Oral Function and Prosthetic Dentistry, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'M F L', 'Initials': 'MFL', 'LastName': 'Navarro', 'Affiliation': 'Department of Dental Materials, Endodontics and Operative Dentistry, Bauru School of Dentistry, Bauru, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-018-2787-1']
2562,31418966,Home-based isometric handgrip training on RBP in hypertensive adults-Partial preliminary findings from RCT.,"OBJECTIVE
The aim of this study is to confirm whether 8 weeks of home-based isometric handgrip (IHG) training would reduce resting blood pressure (RBP) in an adult Indian population.
METHODOLOGY
Hypertensive patients (Stage 1 [previously prehypertension] and Stage 2 [previously Stage 1 hypertension]) aged 30-45 years, male and female, were included.
INTERVENTION
Two groups were included (active control group and IHG training group at 30% of maximal voluntary isometric contraction). Outcomes of this study were resting pulse rate (PR) and RBP, which were taken at baseline and after 8 weeks. Stratified randomization was done by sex and hypertension grade. The study was a double-blind intervention (both participants and the assessor were blinded to intervention allotment).
RESULTS
Forty hypertensive individuals were randomly assigned to a control (N = 20) and an 8-week home-based IHG training (N = 20) using a stratified random sampling technique. Each training session consisted of 4 × 2 min bouts with a 4-min rest between bouts for 8 weeks. Resting PR and RBP were taken at baseline and after 8 weeks. After 8 weeks, there was a significant reduction in blood pressure and PR values in the IHG group as compared with those in the control group: systolic blood pressure (mean difference, MD -8.75 mmHg; 95% CI [-6.51, -10.39]); diastolic blood pressure (MD -8.35 mmHg; 95% CI [-6.25, -10.45]); mean arterial pressure (MD -8.13 mmHg; 95% CI [-6.21, -10.05]); and PR (MD -8.90 mmHg; 95% CI [-5.08, -12.72].
CONCLUSION
On the basis of study findings, home-based IHG training can be used as an adjunct to control BP in the initial stage of hypertension in an Indian population.",2020,"After 8 weeks, there was a significant reduction in blood pressure and PR values in the IHG group as compared with those in the control group: systolic blood pressure (mean difference, MD -8.75 mmHg; 95% CI [-6.51, -10.39]); diastolic blood pressure (MD -8.35 mmHg; 95% CI [-6.25, -10.45]); mean arterial pressure (MD -8.13 mmHg; 95% CI [-6.21, -10.05]); and PR (MD","['hypertensive adults-Partial preliminary findings from RCT', 'Hypertensive patients (Stage 1 [previously prehypertension] and Stage 2 [previously Stage 1 hypertension]) aged 30-45 years, male and female, were included', 'adult Indian population', 'Forty hypertensive individuals']","['Home-based isometric handgrip training', 'home-based isometric handgrip (IHG) training', '8-week home-based IHG training', 'IHG training group at 30% of maximal voluntary isometric contraction']","['Resting PR and RBP', 'mean arterial pressure', 'PR (MD', 'diastolic blood pressure', 'systolic blood pressure', 'resting pulse rate (PR) and RBP', 'blood pressure and PR values', 'resting blood pressure (RBP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0484395,"After 8 weeks, there was a significant reduction in blood pressure and PR values in the IHG group as compared with those in the control group: systolic blood pressure (mean difference, MD -8.75 mmHg; 95% CI [-6.51, -10.39]); diastolic blood pressure (MD -8.35 mmHg; 95% CI [-6.25, -10.45]); mean arterial pressure (MD -8.13 mmHg; 95% CI [-6.21, -10.05]); and PR (MD","[{'ForeName': 'Sonu', 'Initials': 'S', 'LastName': 'Punia', 'Affiliation': 'Department of Physiotherapy, GJUST, Hisar, India.'}, {'ForeName': 'Sivachidambaram', 'Initials': 'S', 'LastName': 'Kulandaivelan', 'Affiliation': 'Department of Physiotherapy, GJUST, Hisar, India.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1806']
2563,32495521,Fall Prevention and Anti-Osteoporosis in Osteopenia Patients of 80 Years of Age and Older: A Randomized Controlled Study.,"To evaluate the effects of two fall-prevention and anti-osteoporotic protocols in elderly patients with osteopenia (OPA).
METHODS
The present randomized controlled study included patients with OPA (n =123). The age of these patients was ≥80 years old, with the mean age of 83.54 ± 2.99 years, and the male-to-female ratio was 2.97:1.00. Fall-prevention guidance was given to all patients. Patients in the experiment group (n = 62) orally received 600 mg/d of calcium carbonate, 0.5 μg/d of alfacalcidol, and 70 mg/week of alendronate, while patients in the control group (n = 61) orally received 600 mg/d of calcium carbonate and 0.5 μg/d of alfacalcidol for 18 months. The grip strength, gait speed, bone turnover markers, serum calcium, serum phosphorus, parathyroid hormone (PTH), and bone mineral density were measured, and the Timed Up and Go (TUG) test and the chair rising test (CRT) were performed. Falls, fragility fractures, medication compliance, and side effects of the drugs were recorded.
RESULTS
The serum levels of bone turnover markers (type I procollagen amino-terminal peptide [P1NP], type I collagen carboxyl terminal peptide [β-CTx], and osteocalcin [OC]) decreased, while the bone mineral density of the lumbar spine and bilateral femoral neck increased after treatment in the experiment group (P < 0.05, P < 0.01). The rate of change in bone mineral density of the bilateral femoral neck was higher in the experiment group than the control group (3.43% vs 0.03%, P < 0.05; 2.86% vs -0.02%, P < 0.01). After treatment, the proportion of patients with increased hip T scores in the experiment group (66.1%, 41/62) was significantly higher than the proportion (35.0%, 21/60) in the control group (P = 0.001). The incidence of fall decreased in both groups after treatment compared to that before treatment (54.8% vs 33.9% and 54.1% vs 36.7%, respectively; P < 0.05). The incidence of fragility fractures was lower in the experiment group than the control group (8.1% vs 20.0%, P = 0.057). During the intervention period, the incidence of fragility fractures in patients who did not fall (3.8%, 3/79) was significantly lower than that in patients who fell (32.6%, 14/43) (P = 0.000). The risk of fragility fractures was significantly lower in patients who did not fall compared to patients who fell (relative risk: 0.117, 95% confidence interval: 0.035-0.384).
CONCLUSION
The combination of alendronate sodium with alfacalcidol and calcium can significantly improve the bone mineral density of the lumbar spine and femoral neck. For older patients with OPA, subjectively paying attention to avoiding falls can significantly reduce the risk of fragility fractures.",2020,"The rate of change in bone mineral density of the bilateral femoral neck was higher in the experiment group than the control group (3.43% vs 0.03%, P < 0.05; 2.86% vs -0.02%, P < 0.01).","['older patients with OPA', 'Osteopenia Patients of 80\u2009Years of Age and Older', 'The age of these patients was ≥80\u2009years old, with the mean age of 83.54 ±\u20092.99\u2009years, and the male-to-female ratio was 2.97:1.00', 'patients with OPA (n =123', 'elderly patients with osteopenia (OPA']","['calcium carbonate, 0.5 μg/d of alfacalcidol, and 70 mg/week of alendronate', 'calcium carbonate and 0.5 μg/d of alfacalcidol', 'fall-prevention and anti-osteoporotic protocols', 'alendronate sodium with alfacalcidol and calcium']","['risk of fragility fractures', 'serum levels of bone turnover markers (type I procollagen amino-terminal peptide', 'hip T scores', 'incidence of fragility fractures', 'rate of change in bone mineral density of the bilateral femoral neck', 'bone mineral density of the lumbar spine and bilateral femoral neck', 'grip strength, gait speed, bone turnover markers, serum calcium, serum phosphorus, parathyroid hormone (PTH), and bone mineral density', 'Timed Up and Go (TUG) test and the chair rising test (CRT', 'Falls, fragility fractures, medication compliance, and side effects', 'incidence of fall', 'bone mineral density of the lumbar spine and femoral neck', 'type I collagen carboxyl terminal peptide [β-CTx], and osteocalcin [OC']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0700482', 'cui_str': 'Alendronate sodium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}]",,0.0191453,"The rate of change in bone mineral density of the bilateral femoral neck was higher in the experiment group than the control group (3.43% vs 0.03%, P < 0.05; 2.86% vs -0.02%, P < 0.01).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University Key Laboratory of Otolaryngology Head and Neck Surgery (Ministry of Education of China), Beijing institute of Otolaryngology, Beijing, China.'}, {'ForeName': 'Ming-Zhao', 'Initials': 'MZ', 'LastName': 'Qin', 'Affiliation': 'Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jin-Ping', 'Initials': 'JP', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}]",Orthopaedic surgery,['10.1111/os.12701']
2564,32495666,'Loss of efficacy of topical 5% permethrin for treating scabies: an Austrian single-center study'.,"Background: Scabies is a contagious, itchy, parasitic infection of the skin. It is transmitted by skin-to-skin contact or by contact with contaminated material. Recent observations, especially in the outpatient setting, suggest there is decreasing efficacy of the standard treatment of choice, topical 5% permethrin cream. Objectives: To assess the efficacy and safety of topical permethrin for scabies treatment in patients. Methods: Patients visiting the Dermatology outpatient clinic with dermatoscopy-assured scabies were assessed for enrollment in the study. In total, 55 patients were enrolled and sequentially randomized into three groups. Group (A) received permethrin 5% cream on two occasions within a one-week interval, while (intensive) group (B) received the same administration of permethrin 5% cream plus the daily application of the cream on dermatoscopically verified affected sites (hands and/or genitals and/or feet). The treatment was evaluated at 3 weeks by dermatoscopy. Group A patients who failed to respond were allowed to repeat the treatment according to the group B scheme and were again evaluated after 3 weeks (group C). Results: Two applications of permethrin 5% cream (group A) produced a cure rate of 29% at follow-up. The intense application of permethrin 5% cream (group B) was not superior at follow-up (cure rate 31%). Patients who were retreated according to the intense scheme (group C) did not benefit at all. Conclusion: Mite populations with reduced susceptibility to permethrin exist in Austria and necessitate the evaluation of alternative treatment regimens.Key MessagesHuman scabies is a rising major public health issue worldwide and has been designated as a neglected tropical disease by the World Health Organization.Resistance to permethrin, the most widely prescribed first-line therapy for scabies is to date underreported.At present, treatment recommendations remain controversially discussed as official guidelines do not address current development of resistances, and therefore their clinical applicability is limited.",2020,The intense application of permethrin 5% cream (group B) was not superior at follow-up (cure rate 31%).,"['patients', 'Patients visiting the Dermatology outpatient clinic with dermatoscopy-assured scabies were assessed for enrollment in the study', '55 patients']","['topical permethrin', 'permethrin 5% cream', 'topical 5% permethrin', 'permethrin 5% cream plus the daily application of the cream']","['cure rate', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1449565', 'cui_str': 'Dermatoscopy'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3219686', 'cui_str': 'Permethrin-containing product in cutaneous dose form'}, {'cui': 'C0358202', 'cui_str': 'Permethrin stain 50 mg/g cutaneous cream'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",55.0,0.0178341,The intense application of permethrin 5% cream (group B) was not superior at follow-up (cure rate 31%).,"[{'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Meyersburg', 'Affiliation': 'Department of Dermatology and Allergology, University Hospital Salzburg of the Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kaiser', 'Affiliation': 'Department of Psychosomatics and Inpatient Psychotherapy, University Hospital of Psychiatry and Psychotherapy, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Johann Wolfgang', 'Initials': 'JW', 'LastName': 'Bauer', 'Affiliation': 'Department of Dermatology and Allergology, University Hospital Salzburg of the Paracelsus Medical University Salzburg, Salzburg, Austria.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1774489']
2565,31375226,Information retention of orthodontic patients and parents: A randomized controlled trial.,"INTRODUCTION
A randomized controlled trial was undertaken to compare the efficacy of 3 methods of delivering information on short- and long-term recall of information in orthodontic patients and parents.
METHODS
Participants who received an audiovisual presentation on orthodontic treatment were randomly allocated to 1 of 3 written information groups (leaflets, generic mind map, or participant's customized mind map). A questionnaire was used to assess short- and long-term retention of information (maximum score 30).
RESULTS
Eighty-eight patients (94.6%) and 77 parents (86.5%) completed the study. The average knowledge scores at baseline for the patient groups were 17.71 95 CI 16.28-19.14), 16.58 (14.67-18.49), and 17.37 (15.92-18.81), respectively. The parents' knowledge scores for the 3 groups were 19.06 (17.51-20.62), 19.39 (17.44-21.35), and 18.76 (17.19-20.33), respectively. The short- and long-term knowledge scores improved over baseline in all 3 groups (P <0.0001). The parents achieved higher scores than the patients (P = 0.002) and their rate of forgetting information was less. The knowledge scores of the mind map groups were higher than that of the leaflet group for all cohorts (P = 0.025). No statistical difference was found between the type of mind map. The correlation between patient and parent knowledge scores was significant (P <0.0001) at all 3 time points.
CONCLUSIONS
Provision of an audiovisual presentation supplemented with 1 of 3 written information methods is an effective way of delivering information. There was a significant improvement in the retention of information with the use of mind maps compared with leaflets. The generic mind map is equally as effective, more consistent in information delivered, and less labor intensive than the individual customized mind map and therefore would be our recommendation. Participation of parents is important because they comprehend and retain information better. In this study, 100% of parents shared information with their children, perhaps improving the patients' recall.",2019,The short- and long-term knowledge scores improved over baseline in all 3 groups (P <0.0001).,"['Eighty-eight patients (94.6%) and 77 parents (86.5%) completed the study', 'Participants who received an audiovisual presentation on orthodontic treatment', 'orthodontic patients and parents']","[""3 written information groups (leaflets, generic mind map, or participant's customized mind map""]","['average knowledge scores', ""parents' knowledge scores"", 'knowledge scores', 'retention of information with the use of mind maps', 'rate of forgetting information', 'short- and long-term knowledge scores']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",88.0,0.100088,The short- and long-term knowledge scores improved over baseline in all 3 groups (P <0.0001).,"[{'ForeName': 'John Hyun-Baek', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': ""Royal Bournemouth Hospital, Bournemouth, United Kingdom; Faculty of Dentistry, Oral and Craniofacial Sciences, King's College London, London, United Kingdom. Electronic address: korean-dentist@hotmail.com.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Power', 'Affiliation': 'Royal Bournemouth Hospital, Bournemouth, United Kingdom.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Thickett', 'Affiliation': 'Royal Bournemouth Hospital, Bournemouth, United Kingdom.'}, {'ForeName': 'Manoharan', 'Initials': 'M', 'LastName': 'Andiappan', 'Affiliation': ""Faculty of Dentistry, Oral and Craniofacial Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Newton', 'Affiliation': ""Faculty of Dentistry, Oral and Craniofacial Sciences, King's College London, London, United Kingdom.""}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.03.017']
2566,32496074,"Effects of the COVID-19 pandemic and nationwide lockdown on trust, attitudes toward government, and well-being.","The contagiousness and deadliness of COVID-19 have necessitated drastic social management to halt transmission. The immediate effects of a nationwide lockdown were investigated by comparing matched samples of New Zealanders assessed before (N prelockdown = 1,003) and during the first 18 days of lockdown (N lockdown = 1,003). Two categories of outcomes were examined: (a) institutional trust and attitudes toward the nation and government and (b) health and well-being. Applying propensity score matching to approximate the conditions of a randomized controlled experiment, the study found that people in the pandemic/lockdown group reported higher trust in science, politicians, and police, higher levels of patriotism, and higher rates of mental distress compared to people in the prelockdown prepandemic group. Results were confirmed in within-subjects analyses. The study highlights social connectedness, resilience, and vulnerability in the face of adversity and has applied implications for how countries face this global challenge. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Two categories of outcomes were examined: (a) institutional trust and attitudes toward the nation and government and (b) health and well-being.,[],"['COVID-19 pandemic and nationwide lockdown', 'nationwide lockdown']","['institutional trust and attitudes toward the nation and government and (b) health and well-being', 'mental distress']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0235109', 'cui_str': 'Mental distress'}]",,0.0275454,Two categories of outcomes were examined: (a) institutional trust and attitudes toward the nation and government and (b) health and well-being.,"[{'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Sibley', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Lara M', 'Initials': 'LM', 'LastName': 'Greaves', 'Affiliation': 'School of Social Sciences, University of Auckland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Satherley', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Wilson', 'Affiliation': 'School of Psychology, Victoria University of Wellington.'}, {'ForeName': 'Nickola C', 'Initials': 'NC', 'LastName': 'Overall', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Carol H J', 'Initials': 'CHJ', 'LastName': 'Lee', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Milojev', 'Affiliation': 'School of Humanities, University of Auckland.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bulbulia', 'Affiliation': 'School of Humanities, University of Auckland.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Osborne', 'Affiliation': 'School of Psychology, University of Auckland.'}, {'ForeName': 'Taciano L', 'Initials': 'TL', 'LastName': 'Milfont', 'Affiliation': 'School of Psychology, Victoria University of Wellington.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Houkamau', 'Affiliation': 'Department of Management and International Business, University of Auckland.'}, {'ForeName': 'Isabelle M', 'Initials': 'IM', 'LastName': 'Duck', 'Affiliation': 'Silverdale Medical.'}, {'ForeName': 'Raine', 'Initials': 'R', 'LastName': 'Vickers-Jones', 'Affiliation': 'School of Psychology, University of Queensland.'}, {'ForeName': 'Fiona Kate', 'Initials': 'FK', 'LastName': 'Barlow', 'Affiliation': 'School of Psychology, University of Queensland.'}]",The American psychologist,['10.1037/amp0000662']
2567,31415087,"Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial.","CONTEXT
The thermoregulatory center in the hypothalamus is stimulated by neurokinin 3 receptor (NK3R) activation and inhibited by estrogen-negative feedback. This balance is disrupted in menopause, producing vasomotor symptoms (VMSs).
OBJECTIVE
To evaluate safety and efficacy of the NK3R antagonist fezolinetant in menopausal VMSs.
DESIGN
Twelve-week, double-blind, randomized, placebo-controlled study.
SETTING
Eight Belgian centers from September 2015 to October 2016.
PARTICIPANTS
Generally healthy menopausal women aged 40 to 65 years with moderate/severe VMSs.
INTERVENTIONS
Subjects were randomized (1:1) to 90 mg of fezolinetant twice daily or placebo for 12 weeks.
MAIN OUTCOME MEASURES
Subjects captured VMS severity and frequency using an electronic diary. The primary outcome was change from baseline to week 12 in total VMS score with fezolinetant vs placebo. Secondary outcomes included timing of changes in frequency and severity of moderate/severe VMSs and quality-of-life assessments at weeks 4, 8, and 12. Pharmacodynamic and pharmacokinetic effects were assessed, as were safety and tolerability.
RESULTS
Of 122 subjects screened, 87 were randomized and 80 (92%) completed the study. At week 12, fezolinetant significantly reduced total VMS score vs placebo (-26.5 vs -12.2, P < 0.001) and decreased mean frequency of moderate/severe VMSs by five episodes per day vs placebo. Severity and frequency of moderate/severe VMSs were reduced from the first day of treatment. Improvements were achieved in all quality-of-life measures. Fezolinetant was well tolerated. The most common fezolinetant-related adverse event was gastrointestinal disorder (n = 6).
CONCLUSIONS
Fezolinetant rapidly and significantly reduced moderate/severe VMSs, supporting its potential as an effective nonhormonal treatment option for menopausal women.",2019,"At Week 12, fezolinetant significantly reduced total VMS score versus placebo (-26.5 versus -12.2, P<0.001) and decreased mean frequency of moderate/severe VMS by 5 episodes per day versus placebo.","['Generally healthy menopausal women aged 40-65 years with moderate/severe VMS', 'Of 122 subjects screened, 87 were randomized and 80 (92%) completed the study', 'Eight Belgian centers from September 2015 to October 2016', 'menopausal women', 'menopausal VMS']","['NK3R antagonist fezolinetant', 'placebo', 'fezolinetant 90 mg BID or placebo']","['Severity and frequency of moderate/severe VMS', 'total VMS score', 'safety and tolerability', 'mean frequency of moderate/severe VMS', 'Pharmacodynamic and pharmacokinetic effects', 'moderate/severe VMS', 'tolerated', 'frequency and severity of vasomotor symptoms and improved quality of life', 'timing of changes in frequency and severity of moderate/severe VMS and quality-of-life assessments']","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C4547455', 'cui_str': 'fezolinetant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",122.0,0.428607,"At Week 12, fezolinetant significantly reduced total VMS score versus placebo (-26.5 versus -12.2, P<0.001) and decreased mean frequency of moderate/severe VMS by 5 episodes per day versus placebo.","[{'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Depypere', 'Affiliation': 'Breast and Menopause Clinic, University Hospital, Ghent, Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Timmerman', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Donders', 'Affiliation': 'Femicare vzw, Tienen, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sieprath', 'Affiliation': 'Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ramael', 'Affiliation': 'Ogeda SA, Gosselies, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Combalbert', 'Affiliation': 'Ogeda SA, Gosselies, Belgium.'}, {'ForeName': 'Hamid R', 'Initials': 'HR', 'LastName': 'Hoveyda', 'Affiliation': 'Ogeda SA, Gosselies, Belgium.'}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Fraser', 'Affiliation': 'Ogeda SA, Gosselies, Belgium.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00677']
2568,32495671,Clinical effectiveness of position management and manual rotation of the fetal position with a U-shaped birth stool for vaginal delivery of a fetus in a persistent occiput posterior position.,"OBJECTIVE
To examine the effects of position management, manual rotation of the fetal position, and using a U-shaped birth stool in primiparous women with a fetus in a persistent occiput posterior position.
METHODS
This was a prospective pilot study of women who delivered at Gansu Provincial Maternity and Child-care Hospital between January and June 2018. The women were divided into the position management ([PM] position management, manual rotation of fetal position, use of a U-shaped birth stool at different stages, and routine nursing) and control groups (position selected by women and routine nursing).
RESULTS
There were 196 women in the PM group and 188 in the control group. There were no significant differences in maternal age, gestational weeks, newborn weight, and the neonatal asphyxia rate between the PM and control groups. The duration of labor was shorter in the PM group than in the control group. Pain and blood loss 2 hours after delivery and the episiotomy rate were significantly lower in the PM group than in the control group.
CONCLUSION
Applying position management, manual rotation of the fetal position, and using a U-shaped birth stool should be considered for women with a fetus in a persistent occiput posterior position.",2020,"Pain and blood loss 2 hours after delivery and the episiotomy rate were significantly lower in the PM group than in the control group.
","['196 women in the PM group and 188 in the control group', 'women who delivered at Gansu Provincial Maternity and Child-care Hospital between January and June 2018', 'primiparous women with a fetus in a persistent occiput posterior position']","['position management and manual rotation of the fetal position with a U-shaped birth stool', 'position management ([PM] position management, manual rotation of fetal position, use of a U-shaped birth stool at different stages, and routine nursing) and control groups (position selected by women and routine nursing', 'position management, manual rotation of the fetal position, and using a U-shaped birth stool']","['maternal age, gestational weeks, newborn weight, and the neonatal asphyxia rate', 'duration of labor', 'Pain and blood loss 2 hours after delivery and the episiotomy rate']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0856256', 'cui_str': 'Occiput posterior'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1286298', 'cui_str': 'Position of fetus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C1443305', 'cui_str': 'Birthing stool'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}]",,0.0261708,"Pain and blood loss 2 hours after delivery and the episiotomy rate were significantly lower in the PM group than in the control group.
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Perinatal Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Tongying', 'Initials': 'T', 'LastName': 'Yi', 'Affiliation': 'Delivery Room, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Perinatal Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Ministry of Science and Technology Development, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Perinatal Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesia Surgery, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Prenatal Diagnosis Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Prenatal Diagnosis Center, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}, {'ForeName': 'Zhaoyan', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Department of Obstetrics, Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China.'}]",The Journal of international medical research,['10.1177/0300060520924275']
2569,32495698,Feasibility of collection and analysis of microbiome data in a longitudinal randomized trial of community gardening.,"Aim: We explored the feasibility of collecting and analyzing human microbiome data in a longitudinal randomized controlled trial of community gardening. Methods & materials: Participants were randomly assigned to gardening (N = 8) or control (N = 8). Participants provided stool, mouth, hand and forehead microbiome samples at six timepoints. Analyses combined mixed models with Qiita output. Results: Participant satisfaction was high, with 75% of participants completing evaluations. While no microbial effects were statistically significant due to small sample size, the analysis pipeline utility was tested. Conclusion: Longitudinal collection and analysis of microbiome data in a community gardening randomized controlled trial is feasible. The analysis pipeline will be useful in larger studies for assessment of the pathway between microbiota, gardening and health outcomes.",2020,"Participant satisfaction was high, with 75% of participants completing evaluations.",[],[],['Participant satisfaction'],[],[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.17883,"Participant satisfaction was high, with 75% of participants completing evaluations.","[{'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Gascon', 'Affiliation': 'ISGlobal, Barcelona, Spain.'}, {'ForeName': 'Kylie K', 'Initials': 'KK', 'LastName': 'Harrall', 'Affiliation': 'Lifecourse Epidemiology of Adiposity and Diabetes Center, Colorado School of Public Health, University of Colorado Denver, Aurora, CO 800455, USA.'}, {'ForeName': 'Alyssa W', 'Initials': 'AW', 'LastName': 'Beavers', 'Affiliation': 'Department of Food Science and Human Nutrition, Michigan State University, East Lansing, MI 488246, USA.'}, {'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'Glueck', 'Affiliation': 'Department of Pediatrics, University of Colorado School of Medicine, University of Colorado Denver, Anschutz Medical Campus, Aurora, CO 800457, USA.'}, {'ForeName': 'Maggie A', 'Initials': 'MA', 'LastName': 'Stanislawski', 'Affiliation': 'Department of Epidemiology, University of Colorado School of Public Health, University of Colorado Denver, Anschutz Medical Campus, Aurora, CO 800458, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Alaimo', 'Affiliation': 'Department of Food Science and Human Nutrition, Michigan State University, East Lansing, MI 488246, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Villalobos', 'Affiliation': 'Environmental Studies, University of Colorado Boulder, Boulder, CO 488246, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hebert', 'Affiliation': 'Department of Epidemiology and Biostatistics and Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Colombia, SC 8030310, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Dexter', 'Affiliation': 'Department of Endocrinology, University of Colorado School of Public Health, University of Colorado Denver, Anschutz Medical Campus, Aurora, CO 2920811, USA.'}, {'ForeName': 'Kaigang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Health & Exercise Science, Colorado State University, CO 8004512, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Litt', 'Affiliation': 'ISGlobal, Barcelona, Spain.'}]",Future microbiology,['10.2217/fmb-2019-0195']
2570,32141277,"Whey protein isolate or concentrate combined with concurrent training does not augment performance, cardiorespiratory fitness, or strength adaptations.","BACKGROUND
Protein supplementation alters both strength and endurance training adaptations individually; however less is known regarding protein supplementation during concurrent training. The primary purpose of this study was to investigate the effects of whey protein supplementation during six weeks of concurrent training on performance, cardiorespiratory fitness, and maximal strength adaptations, as well as acute hormonal and immune responses. A secondary purpose was to explore the effects of two types of whey protein powders on these latter variables.
METHODS
Thirty-one participants were randomly assigned to supplement with a placebo (PLA; N.=10), whey protein isolate (WPI; N.=10), or whey protein concentrate (WPC; N.=11) in addition to their habitual diet. Total protein intake was 1.2, 3.5, and 3.5 g/kg/day for PLA, WPI, WPC groups, respectively. Exercise testing was performed before and after 6 weeks of concurrent training. Blood samples were obtained at rest, and 5 and 60 minutes after a simulated 2000 m rowing race prior to and after training.
RESULTS
There were similar but significant improvements in cardiorespiratory fitness (PLA +7.5%; WPI +3.9%; WPC +6.9%), upper body strength (PLA +5.5%; WPI +5.1%; WPC +6.7%), lower body strength (PLA +13.6%; WPI +9.4%; WPC +14.1%) and 2000m rowing performance (PLA -2.5%; WPI -2.3%; WPC -2.3%) in all groups, P<0.05. As well, hormonal and immune responses to acute exercise were similar over time and between groups.
CONCLUSIONS
Whey protein supplementation did not differentially influence performance, cardiorespiratory fitness, upper and lower body strength, immune or hormonal adaptations following 6 weeks of concurrent training.",2020,"CONCLUSIONS
Whey protein supplementation did not differentially influence performance, cardiorespiratory fitness, upper and lower body strength, immune or hormonal adaptations following 6 weeks of concurrent training.",['Thirty-one participants'],"['whey protein supplementation', 'whey protein concentrate (WPC; n=11) in addition to their habitual diet', 'placebo (PLA']","['performance, cardiorespiratory fitness, and maximal strength adaptations', 'lower body strength', 'acute hormonal and immune responses', 'performance, cardiorespiratory fitness, or strength adaptations', 'Total protein intake', 'performance, cardiorespiratory fitness, upper and lower body strength, immune or hormonal adaptations', 'upper body strength', 'cardiorespiratory fitness']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}]",31.0,0.0142858,"CONCLUSIONS
Whey protein supplementation did not differentially influence performance, cardiorespiratory fitness, upper and lower body strength, immune or hormonal adaptations following 6 weeks of concurrent training.","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education, Faculty of Education, Brandon University, Brandon, MB, Canada - forbess@brandonu.ca.'}, {'ForeName': 'Gordon J', 'Initials': 'GJ', 'LastName': 'Bell', 'Affiliation': 'Faculty of Kinesiology, Sport and Recreation, University of Alberta, Edmonton, AB, Canada.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10314-1']
2571,32495992,"Assessment of Energy and Protein Requirements in Relation to Nitrogen Kinetics, Nutrition, and Clinical Outcomes in Infants Receiving Early Enteral Nutrition Following Cardiopulmonary Bypass.","BACKGROUND
Nutrition therapies in children with congenital heart disease (CHD) after cardiopulmonary bypass (CPB) is crucial, but energy and protein requirements remain undefined. We assessed energy and protein requirements, with nitrogen kinetics and clinical outcomes, in infants with complex CHD following CPB.
METHODS
Infants were randomized to control (1.3 g/kg/d), moderate protein (MP, 2.5 g/kg/d), or high protein (HP, 4 g/kg/d) groups. Resting energy expenditure (REE) was measured 6 hours post-CPB and then at 24-hour intervals, using indirect calorimetry to formulate energy intakes. Enteral formula feeding was initiated 6 hours post-CPB and continued for 5 days. Nitrogen balance (NB); urea nitrogen waste and nitrogen retention; serum prealbumin level; and hepatic, renal, and cardiac function were measured daily. Mid-upper arm circumference and triceps skinfold were measured preoperatively and 5 days after CPB. Adverse outcomes (bacterial infection, reintubation, and cardiac intensive care unit (CICU) stay > 8 days) were recorded.
RESULTS
REE was not different across the 3 groups (P = .37). It declined from 62 ± 6 to 57 ± 7 kcal/kg/d over 5 days post-CPB (P = .02). NB and nitrogen retention became positive by day 3 in the HP group but remained negative in the other 2 groups (P = .045-.003), despite higher urea nitrogen waste in the HP group (P < .0001). The HP group had a greater increase in serum prealbumin level and anthropometric measures (P = .009-.03). Other measures were not significantly different across the 3 groups.
CONCLUSIONS
In infants with complex CHD in the first 5 days post-CPB, protein and energy intakes of ≈4 g/kg/d and 60 kcal/kg/d, respectively, led to improved nutrition outcomes without increased adverse events.",2020,The HP group had a greater increase in serum prealbumin level and anthropometric measures (P = .009-.03).,"['Infants Receiving Early Enteral Nutrition Following Cardiopulmonary Bypass', 'Infants', 'infants with complex CHD following CPB', 'children with congenital heart disease (CHD) after cardiopulmonary bypass (CPB']",[],"['NB and nitrogen retention became positive', 'Resting energy expenditure (REE', 'Adverse outcomes (bacterial infection, reintubation, and cardiac intensive care unit (CICU) stay > 8 days', 'Nitrogen balance (NB); urea nitrogen waste and nitrogen retention; serum prealbumin level; and hepatic, renal, and cardiac function', 'serum prealbumin level and anthropometric measures']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0429631', 'cui_str': 'Nitrogen balance'}, {'cui': 'C0235432', 'cui_str': 'Nitrogen retention'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C1273508', 'cui_str': 'Serum prealbumin level'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0613378,The HP group had a greater increase in serum prealbumin level and anthropometric measures (P = .009-.03).,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Clinical Physiology Laboratory, Capital Institute of Pediatrics, Graduate School of Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan-Qin', 'Initials': 'YQ', 'LastName': 'Cui', 'Affiliation': ""Cardiac Intensive Care Unit, Heart Center, Guangzhou Women and Children's, Guangzhou Medical University, Guangzhou, Guangdong Province, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Department of Cardiac Surgery, Children's Hospital affiliated to Capital Institute of Pediatrics, Beijing, China.""}, {'ForeName': 'Xin-Xin', 'Initials': 'XX', 'LastName': 'Chen', 'Affiliation': ""Department of Pediatric Surgery, Guangdong Provincial Key Laboratory of Research in Structural Birth Defect Disease, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, Guangdong Province, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Physiology Laboratory, Capital Institute of Pediatrics, Graduate School of Peking Union Medical College, Beijing, China.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1863']
2572,32495673,Impact of enhanced recovery after surgery on postoperative neutrophil-lymphocyte ratio in patients with colorectal cancer.,"OBJECTIVE
To investigate the impact of enhanced recovery after surgery (ERAS) on the postoperative neutrophil-lymphocyte ratio (NLR) in patients with colorectal cancer.
METHODS
A total of 200 patients with colorectal cancer who underwent surgery between January 2015 and November 2018 were enrolled in the study. They were divided into a traditional treatment group (n=100) and an ERAS group (n=100). The traditional treatment group underwent radical laparoscopic colorectal surgery, and the ERAS group underwent traditional treatment plus the ERAS protocol (preoperative improvement of glucose tolerance, unconventional indwelling stomach and urinary tubes, intraoperative body temperature management, fluid management, postoperative pain management, early oral feeding, and early activities). Clinical data were collected for all patients. NLR levels before and after surgery, and complications were compared between the two groups.
RESULTS
Postoperative NLR was significantly lower in the ERAS compared with the traditional treatment group. The incidence of complications, including anastomotic leakage, pulmonary infection, urinary tract infection, and cardiopulmonary dysfunction were also significantly lower in the ERAS group.
CONCLUSION
Enhanced recovery after surgery can reduce the increase in postoperative NLR and reduce the occurrence of postoperative complications, which results will be of clinical value.",2020,"The incidence of complications, including anastomotic leakage, pulmonary infection, urinary tract infection, and cardiopulmonary dysfunction were also significantly lower in the ERAS group.
","['patients with colorectal cancer', '200 patients with colorectal cancer who underwent surgery between January 2015 and November 2018 were enrolled in the study']","['surgery (ERAS', 'radical laparoscopic colorectal surgery, and the ERAS group underwent traditional treatment plus the ERAS protocol (preoperative improvement of glucose tolerance, unconventional indwelling stomach and urinary tubes, intraoperative body temperature management, fluid management, postoperative pain management, early oral feeding, and early activities', 'ERAS']","['NLR levels', 'postoperative neutrophil-lymphocyte ratio', 'Postoperative NLR', 'postoperative neutrophil-lymphocyte ratio (NLR', 'incidence of complications, including anastomotic leakage, pulmonary infection, urinary tract infection, and cardiopulmonary dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",200.0,0.0155312,"The incidence of complications, including anastomotic leakage, pulmonary infection, urinary tract infection, and cardiopulmonary dysfunction were also significantly lower in the ERAS group.
","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cancer Radiotherapy Center of Chongqing Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Zhongxue', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",The Journal of international medical research,['10.1177/0300060520925941']
2573,32495742,Simulation-Based Education for Staff Managing Aggression and Externalizing Behaviors in Children With Autism Spectrum Disorder in the Hospital Setting: Pilot and Feasibility Study Protocol for a Cluster Randomized Controlled Trial.,"BACKGROUND
Children with autism spectrum disorder (ASD) frequently demonstrate aggression and externalizing behaviors in the acute care hospital environment. Pediatric acute care nursing staff are often not trained in managing aggression and, in particular, lack confidence in preventing and managing externalizing behaviors in children with ASD. High-fidelity simulation exercises will be used in this study to provide deliberate practice for acute care pediatric nursing staff in the management of aggressive and externalizing behaviors.
OBJECTIVE
The purpose of this study is to conduct a pilot and feasibility cluster randomized controlled trial (RCT) to evaluate the effectiveness of simulation-based education for staff in managing aggression and externalizing behaviors of children with ASD in the hospital setting.
METHODS
This study has a mixed design, with between-group and within-participant comparisons to explore the acceptability and feasibility of delivering a large-scale cluster RCT. The trial process, including recruitment, completion rates, contamination, and completion of outcome measures, will be assessed and reported as percentages. This study will assess the acceptability of the simulation-based training format for two scenarios involving an adolescent with autism, with or without intellectual disability, who displays aggressive and externalizing behaviors and the resulting change in confidence in managing clinical aggression. Two pediatric wards of similar size and patient complexity will be selected to participate in the study; they will be randomized to receive either simulation-based education plus web-based educational materials or the web-based educational materials only. Change in confidence will be assessed using pre- and posttraining surveys for bedside nursing staff exposed to the training and the control group who will receive the web-based training materials. Knowledge retention 3 months posttraining, as well as continued confidence and exposure to clinical aggression, will be assessed via surveys. Changes in confidence and competence will be compared statistically with the chi-square test using before-and-after data to compare the proportion of those who have high confidence between the two arms at baseline and at follow-up. The simulation-based education will be recorded with trained assessors reviewing participants' abilities to de-escalate aggressive behaviors using a validated tool. This data will be analyzed using mean values and SDs to understand the variation in performance of individuals who undertake the training. Data from each participating ward will be collected during each shift for the duration of the study to assess the number of aggressive incidents and successful de-escalation for patients with ASD. Total change in Code Grey activations will also be assessed, with both datasets analyzed using descriptive statistics.
RESULTS
This study gained ethical approval from The Royal Children's Hospital Melbourne Human Research Ethics Committee (HREC) on November 1, 2019 (HREC reference number: 56684). Data collection was completed in February 2020. Data analysis is due to commence with results anticipated by August 2020.
CONCLUSIONS
We hypothesize that this study is feasible to be conducted as a cluster RCT and that simulation-based training will be acceptable for acute care pediatric nurses. We anticipate that the intervention ward will have increased confidence in managing clinical aggression in children with ASD immediately and up to 3 months posttraining.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000139976; http://www.ANZCTR.org.au/ACTRN12620000139976.aspx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/18105.",2020,"We anticipate that the intervention ward will have increased confidence in managing clinical aggression in children with ASD immediately and up to 3 months posttraining.
","['children with ASD', 'patients with ASD', 'Children With Autism', 'adolescent with autism, with or without intellectual disability, who displays aggressive and externalizing behaviors and the resulting change in confidence in managing clinical aggression', 'Children with autism spectrum disorder (ASD', 'children with ASD in the hospital setting']","['simulation-based education plus web-based educational materials or the web-based educational materials only', 'simulation-based education for staff']",['Total change in Code Grey activations'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C1269776', 'cui_str': 'Gray color'}]",,0.196978,"We anticipate that the intervention ward will have increased confidence in managing clinical aggression in children with ASD immediately and up to 3 months posttraining.
","[{'ForeName': 'Marijke Jane', 'Initials': 'MJ', 'LastName': 'Mitchell', 'Affiliation': ""Department of Neurodevelopment and Disability, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Fiona Helen', 'Initials': 'FH', 'LastName': 'Newall', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sokol', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Katrina Jane', 'Initials': 'KJ', 'LastName': 'Williams', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, Australia.'}]",JMIR research protocols,['10.2196/18105']
2574,32495667,"Efficacy of functional magnetic stimulation in improving upper extremity function after stroke: a randomized, single-blind, controlled study.","OBJECTIVE
To clarify the efficacy of functional magnetic stimulation (FMS) in improving hemiplegic upper extremity function in patients with sub-acute stroke.
METHODS
In this randomized controlled trial, 40 sub-acute stroke patients with hemiplegia were recruited from inpatient wards in the Department of Rehabilitation and randomly assigned to two groups. In the FMS group, magnetic stimulation was applied to extensor muscle groups of the affected upper extremity. In the low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) group, stimulation was applied to the contralesional primary motor cortex. All patients received occupational therapy. Hand and upper extremity motor function was evaluated using the Fugl-Meyer Assessment for upper extremity (FMA-UE), and the Barthel Index (BI) evaluated daily living abilities.
RESULTS
The FMA-UE and BI scores were significantly increased in both groups following stimulation. Furthermore, a significant between-group difference was observed in both FMA-UE and BI scores after 2 weeks of therapy. In the FMS group, 6 of 19 patients regained wrist and finger extension abilities, but only 2 patients regained equivalent motor skills in the LF-rTMS group.
CONCLUSIONS
FMS improves paretic upper extremity function and leads to better recovery of motor activity than LF-rTMS. FMS may be a novel modality to improve motor function.",2020,"Hand and upper extremity motor function was evaluated using the Fugl-Meyer Assessment for upper extremity (FMA-UE), and the Barthel Index (BI) evaluated daily living abilities.
","['40 sub-acute stroke patients with hemiplegia were recruited from inpatient wards in the Department of Rehabilitation and randomly assigned to two groups', 'patients with sub-acute stroke', 'upper extremity function after stroke']","['occupational therapy', 'low-frequency repetitive transcranial magnetic stimulation (LF-rTMS', 'functional magnetic stimulation', 'functional magnetic stimulation (FMS']","['wrist and finger extension abilities', 'FMA-UE and BI scores', 'paretic upper extremity function', 'equivalent motor skills', 'Barthel Index (BI) evaluated daily living abilities']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",40.0,0.025792,"Hand and upper extremity motor function was evaluated using the Fugl-Meyer Assessment for upper extremity (FMA-UE), and the Barthel Index (BI) evaluated daily living abilities.
","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xuncan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yinxing', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Guoxing', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xueru', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Zhenlan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The First Hospital of Jilin University, Changchun, Jilin, China.'}]",The Journal of international medical research,['10.1177/0300060520927881']
2575,32141968,Parameterization of the mid-trimester drop in blood pressure trajectory during pregnancy and its utility for predicting preeclampsia.,"OBJECTIVES
The purpose of this study was to parameterize mid-trimester drop in blood pressure (BP) trajectory during pregnancy and to evaluate its utility for predicting preeclampsia.
METHODS
To develop parametric models for BP trajectory during pregnancy, we used data from 7923 Chinese pregnant women with 24 810 routine antenatal care visits. Then, we evaluated the utility of BP trajectory parameters for predicting clinician-diagnosed preeclampsia in a separate sample of 3524 pregnant women from a randomized controlled trial of prenatal vitamin supplementation conducted in the same area. We focused on parameters related to the mid-trimester BP drop, including the gestational age and BP value at the nadir (lowest point), change in BP, velocity, and area under curve during two periods (from 12 weeks of gestation to the nadir and from the nadir to 33 weeks of gestation).
RESULTS
All participants in our analysis had a mid-pregnancy drop in their SBP, DBP, and mean arterial pressure (MAP) trajectories. There were high correlations (|r| > 0.90) among trajectory parameters of the same BP measure. The final prediction model included selective parameters of SBP, DBP, and MAP trajectories, prepregnancy BMI and gestational age at the first antenatal care visit. The area under the receiver-operating curve for predicting preeclampsia was 0.886 (95% confidence interval 0.846--0.926) in the training dataset and 0.802 (0.708--0.895) in the validation dataset.
CONCLUSION
Our novel BP trajectory parameters are informative and can predict preeclampsia at a clinically acceptable level.",2020,The area under the receiver-operating curve for predicting preeclampsia was 0.886,"['3524 pregnant women', '7923 Chinese pregnant women with 24\u200a810 routine antenatal care visits']",['prenatal vitamin supplementation'],"['gestational age and BP value at the nadir (lowest point), change in BP, velocity, and area under curve', 'blood pressure (BP) trajectory', 'blood pressure trajectory', 'selective parameters of SBP, DBP, and MAP trajectories, prepregnancy BMI and gestational age at the first antenatal care visit', 'SBP, DBP, and mean arterial pressure (MAP) trajectories']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}]","[{'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}]","[{'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",3524.0,0.0408078,The area under the receiver-operating curve for predicting preeclampsia was 0.886,"[{'ForeName': 'Baibing', 'Initials': 'B', 'LastName': 'Mi', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'Division of Behavioral Medicine, Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, New York, USA.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Danmeng', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Fangliang', 'Initials': 'F', 'LastName': 'Lei', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Xuelan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Gynecology and Obstetrics, First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Abdal Aziz T', 'Initials': 'AAT', 'LastName': 'Shittu', 'Affiliation': 'Division of Behavioral Medicine, Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, New York, USA.'}, {'ForeName': 'Shaonong', 'Initials': 'S', 'LastName': 'Dang', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}]",Journal of hypertension,['10.1097/HJH.0000000000002395']
2576,32495974,Double recurrence of double cancers: Rhabdomyosarcoma and secondary AML.,,2020,,[],[],[],[],[],[],,0.361475,,"[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kajita', 'Affiliation': 'Division of Hematology/Oncology, Tokyo Metropolitan Children Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Division of Hematology/Oncology, Tokyo Metropolitan Children Medical Center, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Makimoto', 'Affiliation': 'Division of Pathology and Laboratory Medicine, Tokyo Metropolitan Children Medical Center, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Division of Pathology, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yuza', 'Affiliation': 'Division of Hematology/Oncology, Tokyo Metropolitan Children Medical Center, Tokyo, Japan.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14172']
2577,32495899,Correlation between MRAS gene polymorphism and atherosclerosis.,"OBJECTIVE
The aim of this study was to explore the correlation between muscle RAS oncogene homolog (MRAS) gene polymorphism and the onset risk of atherosclerosis (AS).
PATIENTS AND METHODS
A total of 135 AS patients diagnosed and treated in our hospital from November 2017 to October 2018 were randomly enrolled in the observation group. Meanwhile, 150 healthy adults were selected as control group. Venous blood was withdrawn from all the subjects, and DNAs were extracted. MRAS gene loci rs9818870 and rs3755751 were analyzed by the multiplex SNaPshot method, and their correlations with the onset risk of AS were explored.
RESULTS
No statistically significant differences in the frequencies at gene loci were observed between the two groups (p>0.05). Subjects with genotype TT at rs9818870 exhibited significantly higher risk of AS (p=0.041<0.05). The recessive model of rs9818870 (GG + AG/AA) in AS patients with coronary heart disease was correlated with AS (p=0.048<0.05). Similarly, the dominant model of rs3755751 (TT/TC+CC) in those with hypertension was associated with AS (p=0.027<0.05).
CONCLUSIONS
MRAS gene is correlated with the onset of AS to a certain degree.",2020,No statistically significant differences in the frequencies at gene loci were observed between the two groups (p>0.05).,"['150 healthy adults', 'AS patients with coronary heart disease', '135 AS patients diagnosed and treated in our hospital from November 2017 to October 2018 were randomly enrolled in the observation group']",['rs3755751 (TT/TC+CC'],"['Venous blood', 'frequencies at gene loci']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",150.0,0.038921,No statistically significant differences in the frequencies at gene loci were observed between the two groups (p>0.05).,"[{'ForeName': 'Z-Y', 'Initials': 'ZY', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Jiangxi Provincial People's Hospital, Jiangxi Provincial Cardiovascular Disease Institute, Nanchang, China. nadinewzg@163.com.""}, {'ForeName': 'Z-G', 'Initials': 'ZG', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'H-M', 'Initials': 'HM', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Z-T', 'Initials': 'ZT', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Y-Z', 'Initials': 'YZ', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202005_21355']
2578,32496203,Feasibility and Acceptability of a Text Message-Based Intervention to Reduce Overuse of Alcohol in Emergency Department Patients: Controlled Proof-of-Concept Trial.,"BACKGROUND
Emergency department (ED) patients have high rates of risky alcohol use, and an ED visit offers an opportunity to intervene. ED-based screening, brief intervention, and referral to treatment (SBIRT) reduces alcohol use and health care costs. Mobile health (mHealth) interventions may expand the impact of SBIRTs but are understudied in low-resource ED populations.
OBJECTIVE
The objective of this study was to assess the feasibility of and patient satisfaction with a text-based mHealth extension of an ED screening program to reduce risky alcohol use in low-income, urban patients.
METHODS
Research assistants screened a convenience sample of ED patients in person for risky alcohol use via the Alcohol Use Disorders Identification Test (AUDIT). Patients who reported AUDIT scores ≥8 and <20 were informed of their AUDIT score and risk. RAs invited patients with SMS text message-capable phones to receive mROAD (mobilizing to Reduce Overuse of Alcohol in the ED), an SMS text message-based extension of the ED screening program. mROAD is a 7-day program of twice-daily SMS text messages based on the National Institutes of Health's Rethinking Drinking campaign. Participants were allocated to a control group (daily sham text messages without specific guidance on behaviors, such as ""Thanks for taking part!"") or to the mROAD intervention group. Patients were interviewed at 30 days to assess acceptability, satisfaction, and changes in drinking behavior. Satisfaction was examined descriptively. Pre and post measurements of drinking behaviors and motivation were compared, as were differences in change scores between the intervention arms.
RESULTS
Of 1028 patients screened, 95 (9.2%) exhibited risky alcohol use based on AUDIT, and 23/95 (24%) of those patients did not own an SMS text messaging-capable phone; this left 72/95 (76%) eligible patients. Among eligible participants, 48/72 (67%) agreed to enroll; 31/48 (65%) achieved follow-up (18/24 (75%) in the intervention group and 13/24 (55%) in the control group). Participants who completed follow-up reported high satisfaction. Changes in behavior were similar between the arms. Overall, the number of drinking days reported in the prior 30 days decreased by 5.0 (95% CI 1.7-8.3; P=.004), and the number of heavy drinking days decreased by 4.1 (95% CI 1.0 to 7.15, P=.01). Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire. The were no statistical differences in drinking days, heavy drinking days, or motivation to change between the arms.
CONCLUSIONS
The mROAD trial was feasible. Over three-quarters of ED patients with risky alcohol use owned a text message-capable phone, and two-thirds of these patients were willing to participate; only 1 patient opted out of the intervention. Although 35% of patients were lost to follow-up at 30 days, those patients who did follow up had favorable impressions of the program; more than 90% reported that SMS text messages were a ""good way to teach,"" and 89% of intervention arm participants enjoyed the program and found that the messages were motivating. Both the mROAD and sham message groups showed promising changes in alcohol use and motivation to change. mROAD is a feasible intervention that may reduce rates of risky alcohol use in ED patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02158949; https://clinicaltrials.gov/ct2/show/NCT02158949.",2020,"Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire.","['Research assistants screened a convenience sample of ED patients in person for risky alcohol use via the Alcohol Use Disorders Identification Test (AUDIT', 'ED patients', 'low-income, urban patients', 'Emergency Department Patients', '1028 patients screened, 95 (9.2%) exhibited risky alcohol use based on AUDIT, and 23/95 (24%) of those patients did not own an SMS text messaging-capable phone; this left 72/95 (76%) eligible patients']","['Text Message-Based Intervention', 'text-based mHealth extension of an ED screening program', 'Mobile health (mHealth) interventions', 'control group (daily sham text messages without specific guidance on behaviors, such as ""Thanks for taking part!"") or to the mROAD intervention group']","['drinking behaviors and motivation', 'Changes in behavior', 'drinking days, heavy drinking days, or motivation to change between the arms', 'acceptability, satisfaction, and changes in drinking behavior', 'Satisfaction', 'number of drinking days', 'number of heavy drinking days']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.101456,"Patients reported an 11-point increase (95% CI 2.6-20, P=.01, 10% overall increase) in motivation to change alcohol use via the Change Questionnaire.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burner', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Terp', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ford Bench', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Chun Nok', 'Initials': 'CN', 'LastName': 'Lam', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Jesus R', 'Initials': 'JR', 'LastName': 'Torres', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Menchine', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Emergency Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/17557']
2579,32496365,Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial.,"BACKGROUND
Blood flow-restricted resistance training (BFR-RT) has been proven to be safe and efficacious in healthy older adults, but not in cardiovascular disease.
OBJECTIVE
The aim of this study was to investigate the acute and training induced effects of BFR-RT on hemostatic and hemodynamic responses in patients with coronary artery disease (CAD).
METHODS
Stable patients with CAD were randomized to 8 weeks of BFR-RT (30%-40% 1-repetition maximum unilateral knee extension) combined with aerobic training or aerobic training alone (control group). At baseline and after 4 and 8 weeks, blood samples were taken before and after BFR exercise, whereas hemodynamic parameters were monitored throughout the exercise.
RESULTS
Twenty-four patients (12 per group; mean age, 60 ± 2 years; mostly male [75%]) completed the study. The BFR-RT significantly improved systolic blood pressure (-10 mm Hg; P = .020) and tended to lower diastolic blood pressure (-2 mm Hg; P = .066). In contrast, no posttraining alterations were observed in N-terminal prohormone B-type natriuretic hormone, fibrinogen, and D-dimer values. During BFR exercise, all hemodynamic variables significantly increased after the first and second set, whereas blood pressure immediately lowered after the cuff was released in the third set. Last, significant interaction was only observed for repetitions × intensity (P < .001; partial η = 0.908) of diastolic blood pressure at higher exercise intensity (40% 1-repetition maximum).
CONCLUSIONS
The BFR-RT was proven to be safe, with favorable hemodynamic and hemostatic responses in patients with CAD, and can be recommended as an additional exercise modality in cardiac rehabilitation.
TRIAL REGISTRATION
ClinicalTrial.gov Identifier: NCT03087292.",2020,The BFR-RT significantly improved systolic blood pressure (-10 mm Hg; P = .020) and tended to lower diastolic blood pressure (-2 mm Hg; P = .066).,"['Coronary Artery Disease', 'Twenty-four patients (12 per group; mean age, 60 ± 2 years; mostly male [75%]) completed the study', 'patients with coronary artery disease (CAD', 'healthy older adults', 'Stable patients with CAD', 'patients with CAD']","['BFR-RT', 'Blood flow-restricted resistance training (BFR-RT', 'Blood Flow Restriction Resistance Exercise', 'BFR-RT (30%-40% 1-repetition maximum unilateral knee extension) combined with aerobic training or aerobic training alone (control group']","['blood pressure', 'hemostatic and hemodynamic responses', 'systolic blood pressure', 'diastolic blood pressure', 'hemodynamic variables', 'hemodynamic parameters']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0569271,The BFR-RT significantly improved systolic blood pressure (-10 mm Hg; P = .020) and tended to lower diastolic blood pressure (-2 mm Hg; P = .066).,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kambič', 'Affiliation': 'Tim Kambič, MKin Research Fellow, Department of Research, and Education, General Hospital Murska Sobota, Murska Sobota, and PhD Student, Faculty of Sport, University of Ljubljana, Slovenia. Marko Novakovič, MD, PhD Research Fellow and Resident, Department of Vascular Diseases, Division of Internal Medicine, University Medical Centre Ljubljana, Slovenia. Katja Tomažin, PhD Associate Professor of Kinesiology, Faculty of Sport, University of Ljubljana, Ljubljana, Slovenia. Vojko Strojnik, PhD Professor, Faculty of Sport, University of Ljubljana, Slovenia. Mojca Božič-Mijovski, PhD Assistant Professor, Laboratory for Haemostasis and Atherothrombosis, Department of Vascular Diseases, University Medical Centre Ljubljana, Slovenia. Borut Jug, MD, PhD Associate Professor of Medicine, Department of Vascular Diseases, Division of Internal Medicine, University Medical Centre Ljubljana, and Faculty of Medicine, University of Ljubljana, Slovenia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Novaković', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Tomažin', 'Affiliation': ''}, {'ForeName': 'Vojko', 'Initials': 'V', 'LastName': 'Strojnik', 'Affiliation': ''}, {'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Božič-Mijovski', 'Affiliation': ''}, {'ForeName': 'Borut', 'Initials': 'B', 'LastName': 'Jug', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000699']
2580,32496286,Does Educational Handover Influence Subsequent Assessment?,"PURPOSE
Educational handover (i.e., providing information about learners' past performance) is controversial. Proponents argue handover could help tailor learning opportunities. Opponents fear it could bias subsequent assessments and lead to self-fulfilling prophecies. This study examined whether raters provided with reports describing learners' minor weaknesses would generate different assessment scores or narrative comments than those who did not receive such reports.
METHOD
In this 2018 mixed-methods, randomized, controlled, experimental study, clinical supervisors from five postgraduate (residency) programs were randomized into three groups receiving no educational handover (control), educational handover describing weaknesses in medical expertise, and educational handover describing weaknesses in communication. All participants watched the same videos of two simulated resident-patient encounters and assessed performance using a shortened mini-clinical evaluation exercise form. The authors compared mean scores, percentages of negative comments, comments focusing on medical expertise, and comments focusing on communication across experimental groups using repeated-measures analyses of variance. They examined potential moderating effects of rater experience, gender, and mindsets (fixed vs. growth).
RESULTS
Seventy-two supervisors participated. There was no effect of handover report on assessment scores (F(2, 69) = 0.31, P = .74) or percentage of negative comments (F(2, 60) = 0.33, P = .72). Participants who received a report indicating weaknesses in communication generated a higher percentage of comments on communication than the control group (63% vs 50%, P = .03). Participants who received a report indicating weaknesses in medical expertise generated a similar percentage of comments on expertise than the control group (46% vs 47%, P = .98).
CONCLUSIONS
This study provides initial empirical data about the effects of educational handover and suggests that it can-in some circumstances-lead to more targeted feedback without influencing scores. Further studies are required to examine the influence of reports for a variety of performance levels, areas of weakness, and learners.",2020,"Participants who received a report indicating weaknesses in communication generated a higher percentage of comments on communication than the control group (63% vs 50%, P = .03).","['clinical supervisors from five postgraduate (residency) programs', 'Seventy-two supervisors participated']","['no educational handover (control), educational handover describing weaknesses in medical expertise, and educational handover describing weaknesses in communication']",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4319632', 'cui_str': '72'}]","[{'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",[],72.0,0.021339,"Participants who received a report indicating weaknesses in communication generated a higher percentage of comments on communication than the control group (63% vs 50%, P = .03).","[{'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Dory', 'Affiliation': ""V. Dory was, when this study occurred, assistant professor, Department of Medicine, assessment specialist for undergraduate medical education, and core member, Centre for Medical Education, Faculty of Medicine, McGill University, Montreal, Quebec, Canada, and then assistant professor, General Practice, Institut de Recherche Santé et Société and Centre académique de médecine générale, Université catholique de Louvain, Brussels, Belgium. She is currently an educationalist, Department of General Practice, Université de Liège, Liège, Belgium; ORCID: https://orcid.org/0000-0002-5814-5654. D. Danoff is affiliate member, Institute of Health Sciences Education, Faculty of Medicine, McGill University, Montreal, Quebec, Canada. L.H. Plotnick is associate professor and associate chair, Department of Pediatrics, Faculty of Medicine, McGill University, and director, Division of Pediatric Emergency Medicine, Montreal Children's Hospital, McGill University Health Centre, Montreal, Quebec, Canada. She is also associate member, Institute of Health Sciences Education, Faculty of Medicine, McGill University, Montreal, Quebec, Canada. B-A Cummings is associate professor, Department of Medicine, and associate member, Institute of Health Sciences Education, Faculty of Medicine, McGill University, Montreal, Quebec, Canada, ORCID: https://orcid.org/0000-0001-6565-6930. C. Gomez-Garibello is assistant professor, Department of Medicine and Institute of Health Sciences Education and assessment specialist, Postgraduate Medical Education, Faculty of Medicine, McGill University, Montreal, Quebec, Canada; ORCID: http://orcid.org/0000-0003-0288-3081. N.E. Pal is research assistant, Institute of Health Sciences Education, Faculty of Medicine, McGill University, Montreal, Quebec, Canada. S.T. Gumuchian is research assistant, Institute of Health Sciences Education, Faculty of Medicine, McGill University, Montreal, Quebec, Canada. M. Young is associate professor, Institute of Health Sciences Education and Department of Medicine, Faculty of Medicine, McGill University, Montreal, Quebec, Canada; ORCID: http://orcid.org/0000-0002-2036-2119.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Danoff', 'Affiliation': ''}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Plotnick', 'Affiliation': ''}, {'ForeName': 'Beth-Ann', 'Initials': 'BA', 'LastName': 'Cummings', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gomez-Garibello', 'Affiliation': ''}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Pal', 'Affiliation': ''}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Gumuchian', 'Affiliation': ''}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000003528']
2581,32496397,Early inflammatory measures and neurodevelopmental outcomes in preterm infants.,"BACKGROUND
Inflammation may be an important predictor of long-term neurodevelopment in preterm infants. The identification of specific inflammatory biomarkers that predict outcomes is an important research goal.
OBJECTIVES
The purpose of this analysis was to identify associations between an early measure of inflammation and neurodevelopment in very preterm infants and to identify differences in the relationship between inflammation and neurodevelopment based on infant sex and race.
METHODS
We conducted a secondary analysis of data from a randomized controlled trial of a caregiving intervention for preterm infants born less than 33 weeks post-menstrual age. Plasma was collected with a clinically-indicated lab draw by neonatal intensive care unit nurses and analyzed by multiplex assay for cytokines, chemokines, and growth factors. Neurobehavior was assessed by research nurses at the time of discharge from the neonatal intensive care unit using the motor development and vigor and alertness/orientation clusters from the Neurobehavioral Assessment of the Preterm Infant. Neurodevelopment was assessed at six months corrected age by the developmental specialist in the hospital's neonatal follow-up clinic using the Bayley Scales of Infant Development, 3 Edition. We used linear regressions to estimate the effect of cytokine levels on neurodevelopment and allowed the effects to differ by infant sex and race.
RESULTS
In a sample of 62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with six month neurodevelopmental assessments, we found inconsistent associations between single-timepoint inflammatory measures and neurobehavior or neurodevelopment in analyses of the total sample. However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
DISCUSSION
Although early single-timepoint measures of inflammation may be insufficient to predict neurodevelopment for all preterm infants, the effect of inflammation appears to differ by infant sex and race. These demographic factors may be important considerations for future studies of inflammation and neurodevelopment as well was the development of future interventions to optimize outcomes.",2020,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","['very preterm infants', 'preterm infants born less than 33 weeks post-menstrual age', 'preterm infants', '62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with six month neurodevelopmental assessments']",['caregiving intervention'],[],"[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],62.0,0.0941311,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","[{'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': 'The Ohio State University College of Nursing, Columbus, OH The Ohio State University College of Public Health, Division of Biostatistics, Columbus, OH The Ohio State University College of Nursing, Columbus, OH.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Shoben', 'Affiliation': ''}, {'ForeName': 'Rita H', 'Initials': 'RH', 'LastName': 'Pickler', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000448']
2582,32496104,Effectiveness of three brief treatments for recent traumatic events in a low-SES community setting.,"OBJECTIVE
To determine whether brief treatments provide psychological relief after traumatic events in low-resource communities.
METHOD
Participants ( n = 105) who had experienced a traumatic event within the past 6 months were randomly assigned to 1 of 3 4-session treatments: individual eye movement desensitization and reprocessing (EMDR), group-administered stress management with a trauma focus (SMT), or group-administered psychological first aid (PFA). Measures administered pretreatment and at 1-, 3-, and 6-month posttreatment included posttraumatic stress disorder (PTSD) symptoms, posttraumatic cognitions (PTCI), and depressive symptoms (BDI).
RESULTS
The 3 treatment groups all showed significant declines in PTSD, PTCI, and BDI symptoms over time with large prepost effect sizes (median 1-month: 0.96, 3-month: 1.38, 6-month: 1.10). However, the treatment groups showed significantly different rates of decline, with the EMDR group showing the fastest declines-interaction PTCI: F (1, 237) = 5.85, p = .016; depression:, F (1, 239) = 4.90, p = .028-followed by the SMT and then PFA group. While there were significant differences between the EMDR and PFA groups at the 1- and 3-month follow-ups, there were no significant differences in any of the 3 outcome measures at the 6-month follow-up, nor were there significant differences between groups on PTSD symptoms, F (1, 239) = 2.30, p = .131.
CONCLUSION
This study provides preliminary evidence that any of these 3 approaches may be useful in low-resource community settings. Because it gives the quickest relief, EMDR is the preferred approach, followed by SMT, due its ease of administration. PFA provides a reasonable alternative. Where possible, booster sessions should be planned. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The 3 treatment groups all showed significant declines in PTSD, PTCI, and BDI symptoms over time with large prepost effect sizes (median 1-month: 0.96, 3-month: 1.38, 6-month: 1.10).",['Participants ( n = 105) who had experienced a traumatic event within the past 6 months'],"['3 4-session treatments: individual eye movement desensitization and reprocessing (EMDR), group-administered stress management with a trauma focus (SMT), or group-administered psychological first aid (PFA', 'PFA']","['PTSD, PTCI, and BDI symptoms', 'posttraumatic stress disorder (PTSD) symptoms, posttraumatic cognitions (PTCI), and depressive symptoms (BDI']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0016143', 'cui_str': 'First aid'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0214278,"The 3 treatment groups all showed significant declines in PTSD, PTCI, and BDI symptoms over time with large prepost effect sizes (median 1-month: 0.96, 3-month: 1.38, 6-month: 1.10).","[{'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ironson', 'Affiliation': 'Department of Psychology, University of Miami.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hylton', 'Affiliation': 'Department of Psychology, University of Miami.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Gonzalez', 'Affiliation': 'Moffit Cancer Center.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Small', 'Affiliation': 'School of Aging Studies, University of South Florida.'}, {'ForeName': 'Blanche', 'Initials': 'B', 'LastName': 'Freund', 'Affiliation': 'Department of Psychology, University of Miami.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Gerstein', 'Affiliation': 'Jessie Trice Community Health Center.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Thurston', 'Affiliation': 'Jessie Trice Community Health Center.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Bira', 'Affiliation': 'Department of Psychiatry, University of Texas Health San Antonio.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000594']
2583,32496448,Early Goal-directed Therapy During Endovascular Coiling Procedures Following Aneurysmal Subarachnoid Hemorrhage: A Pilot Prospective Randomized Controlled Study.,"BACKGROUND
Maintenance of euvolemia and cerebral perfusion are recommended for the prevention of cerebral vasospasm after aneurysmal subarachnoid hemorrhage (aSAH). We conducted a pilot randomized controlled study to assess the feasibility and efficacy of goal-directed therapy (GDT) to correct fluid and hemodynamic derangements during endovascular coiling in patients with aSAH.
METHODS
This study was conducted between November 2015 and February 2019 at a single tertiary center in Canada. Adult patients with aSAH within 5 days of aneurysm rupture were randomly assigned to receive either GDT or standard therapy during endovascular coiling. The incidence of dehydration at presentation and the efficacy of GDT were evaluated.
RESULTS
Forty patients were allocated to receive GDT (n=21) or standard therapy (n=19). Sixty percent of all patients were found to have dehydration before the coiling procedure commenced. Compared with standard therapy, GDT reduced the duration of intraoperative hypovolemia (mean difference 37.6 [95% confidence interval, 6.2-37.4] min, P=0.006) and low cardiac index (mean difference 30.7 [95% confidence interval, 9.5-56.9] min, P=0.035). There were no differences between the 2 treatment groups with respect to the incidence of vasospasm, stroke, death, and other complications up to postoperative day 90.
CONCLUSIONS
A high proportion of aSAH patients presented at the coiling procedure with dehydration and a low cardiac output state; these derangements were more likely to be corrected if the GDT algorithm was used. Compared with standard therapy, use of the GDT algorithm resulted in earlier recognition and more consistent treatment of dehydration and hemodynamic derangement during endovascular coiling.",2020,"There were no differences between the 2 treatment groups with respect to the incidence of vasospasm, stroke, death, and other complications up to postoperative day 90.
","['Adult patients with aSAH within 5 days of aneurysm rupture', 'patients with aSAH', 'Forty patients', 'Aneurysmal Subarachnoid Hemorrhage', 'cerebral vasospasm after aneurysmal subarachnoid hemorrhage (aSAH', 'November 2015 and February 2019 at a single tertiary center in Canada']","['GDT algorithm', 'GDT', 'standard therapy', 'goal-directed therapy (GDT', 'Endovascular Coiling Procedures', 'GDT or standard therapy']","['low cardiac index', 'incidence of vasospasm, stroke, death, and other complications', 'duration of intraoperative hypovolemia', 'incidence of dehydration at presentation and the efficacy of GDT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0162869', 'cui_str': 'Ruptured aneurysm'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0404094', 'cui_str': 'Intrauterine contraceptive device procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}]",40.0,0.302222,"There were no differences between the 2 treatment groups with respect to the incidence of vasospasm, stroke, death, and other complications up to postoperative day 90.
","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chui', 'Affiliation': 'Departments of Anesthesia & Perioperative Medicine.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Craen', 'Affiliation': 'Departments of Anesthesia & Perioperative Medicine.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dy-Valdez', 'Affiliation': 'Departments of Anesthesia & Perioperative Medicine.'}, {'ForeName': 'Rizq', 'Initials': 'R', 'LastName': 'Alamri', 'Affiliation': 'Departments of Anesthesia & Perioperative Medicine.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Boulton', 'Affiliation': 'Clinical Neurological Science.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Pandey', 'Affiliation': 'Radiology, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Herrick', 'Affiliation': 'Departments of Anesthesia & Perioperative Medicine.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000700']
2584,32140719,Supplementation with Seabuckthorn Oil Augmented in 16:1n-7t Increases Serum Trans-Palmitoleic Acid in Metabolically Healthy Adults: A Randomized Crossover Dose-Escalation Study.,"BACKGROUND
In animal models cis-palmitoleic acid (9-hexadecenoic acid; 16:1n-7c), a lipokine, improves insulin sensitivity, inflammation, and lipoprotein profiles; in humans trans-palmitoleic acid (16:1n-7t) has been associated with lower incidence of type 2 diabetes. The response to dose-escalation of supplements containing cis- and trans-palmitoleic acid has not been evaluated.
OBJECTIVES
We examined dose-escalation effects of oral supplementation with seabuckthorn oil and seabuckthorn oil augmented in 16:1n-7t on serum phospholipid fatty acids (PLFAs).
METHODS
Thirteen participants (7 women and 6 men; age 48 ± 16 y, BMI 30.4 ± 3.7 kg/m2) participated in a randomized, double-blind, crossover, dose-escalation trial of unmodified seabuckthorn oils relatively high in 16:1n-7c (380, 760, and 1520 mg 16:1n-7c/d) and seabuckthorn oils augmented in 16:1n-7t (120, 240, and 480 mg 16:1n-7t/d). Each of the 3 escalation doses was provided for 3 wk, with a 4-wk washout period between the 2 supplements. At the end of each dose period, fasting blood samples were used to determine the primary outcomes (serum concentrations of the PLFAs 16:1n-7t and 16:1n-7c) and the secondary outcomes (glucose homeostasis, serum lipids, and clinical measures). Trends across doses were evaluated using linear regression.
RESULTS
Compared with baseline, supplementation with seabuckthorn oil augmented in 16:1n-7t increased phospholipid 16:1n-7t by 26.6% at the highest dose (P = 0.0343). Supplementation with unmodified seabuckthorn oil resulted in a positive trend across the dose-escalations (P-trend = 0.0199). No significant effects of either supplement were identified on blood glucose, insulin, lipids, or other clinical measures, although this dosing study was not powered to detect such effects. No carryover or adverse effects were observed.
CONCLUSIONS
Supplementation with seabuckthorn oil augmented in 16:1n-7t and unmodified seabuckthorn oil moderately increased concentrations of their corresponding PLFAs in metabolically healthy adults, supporting the use of supplementation with these fatty acids to test potential clinical effects in humans.This trial was registered at clinicaltrials.gov as NCT02311790.",2020,"No carryover or adverse effects were observed.
","['Metabolically Healthy Adults', 'metabolically healthy adults', 'Thirteen participants (7 women and 6 men; age 48\xa0±\xa016']","['seabuckthorn oils', 'unmodified seabuckthorn oil', 'oral supplementation with seabuckthorn oil and seabuckthorn oil', 'unmodified seabuckthorn oils', 'seabuckthorn oil', 'Seabuckthorn Oil', 'supplements containing cis- and trans-palmitoleic acid']","['insulin sensitivity, inflammation, and lipoprotein profiles', 'blood glucose, insulin, lipids, or other clinical measures', 'serum phospholipid fatty acids (PLFAs', 'secondary outcomes (glucose homeostasis, serum lipids, and clinical measures', 'carryover or adverse effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0069966', 'cui_str': 'C16:1n7'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",7.0,0.142098,"No carryover or adverse effects were observed.
","[{'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Huang', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Galluccio', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Peilin', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Friedman School of Nutrition Science & Policy, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Mozaffarian', 'Affiliation': 'Friedman School of Nutrition Science & Policy, Tufts University, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa060']
2585,32140752,"A revalidation and critique of assumptions about urinary sample collection methods, specimen quality and contamination.","INTRODUCTION AND HYPOTHESIS
Midstream urine (MSU) is key in assessing lower urinary tract syndrome (LUTS), but contingent on some assumptions. The aim of this study was to compare the occurrence of contamination and the quality of substrates obtained from four different collections: MSU, catheter specimen urine (CSU), a commercial MSU collecting device (Peezy) and a natural void. Contamination was quantified by differential, uroplakin-positive, urothelial cell counts.
METHODS
This was a single blind, crossover study conducted in two phases. First, we compared the MSU with CSU using urine culture, pyuria counts and differential counting of epithelial cells after immunofluorescence staining for uroplakin III (UP3). Second, we compared the three non-invasive (MSU, Peezy MSU™, natural void) methods using UP3 antibody staining only.
RESULTS
The natural void was best at collecting bladder urinary sediment, with the majority of epithelial cells present derived from the urinary tract. CSU sampling missed much of the urinary sediment and showed sparse culture results. Finally, the MSU collection methods did not capture much of the bladder sediment.
CONCLUSION
We found little evidence for contamination with the four methods. Natural void was the best method for harvesting shed urothelial cells and white blood cells. It provides a richer sample of the inflammatory exudate, including parasitised urothelial cells and the microbial substrate. However, if the midstream sample is believed to be important, the MSU collection device is advantageous.",2020,We found little evidence for contamination with the four methods.,[],['catheter specimen urine (CSU'],[],[],"[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0042037'}]",[],,0.0563349,We found little evidence for contamination with the four methods.,"[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'School of Nursing, Kingston University, Frank Lampl Building, Kingston Hill Campus, London, UK. l.collins@sgul.kingston.ac.uk.'}, {'ForeName': 'Sanchutha', 'Initials': 'S', 'LastName': 'Sathiananthamoorthy', 'Affiliation': 'Department of Renal Medicine, Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rohn', 'Affiliation': 'Department of Renal Medicine, Division of Medicine, University College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Malone-Lee', 'Affiliation': 'Department of Renal Medicine, Division of Medicine, University College London, London, UK.'}]",International urogynecology journal,['10.1007/s00192-020-04272-x']
2586,32496449,The Effect of Atropine on Trigeminocardiac Reflex-induced Hemodynamic Changes During Therapeutic Compression of the Trigeminal Ganglion.,"BACKGROUND
Percutaneous compression of the trigeminal ganglion (PCTG) can induce significant hemodynamic perturbations secondary to the trigeminocardiac reflex (TCR). The aim of this study was to investigate the effect of atropine pretreatment on hemodynamic responses during PCTG for trigeminal neuralgia.
MATERIALS AND METHODS
A total of 120 patients who received PCTG were randomly assigned to control and atropine groups that were pretreated with saline (n=60) and atropine 0.004 mg/kg intravenously (n=60), respectively. Heart rate (HR) and mean arterial pressure (MAP) were measured at 9 timepoints from before induction of anesthesia until the end of the PCTG procedure; the incidence of TCR was also observed.
RESULTS
HR was higher in the atropine compared with control group from the time of skin puncture with the PCTG needle until after the procedure was completed (P<0.05). MAP was also higher in the atropine compared with control group, but only at entry of the needle into the foramen ovale until 1 minute after trigeminal ganglion compression (P<0.05). HR was reduced in both groups during entry of the needle into the foramen ovale and during ganglion compression, but less so in the atropine compared with the control group (P<0.05). MAP increased during PCTG compared with baseline in both groups, but with a larger increase in the atropine group (P<0.05). Two and 52 cases in the control group, and 6 and 1 cases in the atropine group, exhibited a TCR during entry of the needle into the foramen ovale and at ganglion compression, respectively (P<0.05).
CONCLUSION
Pretreatment with atropine was effective in most patients at minimizing abrupt reduction in HR during PCTG.",2020,"MAP increased during PCTG compared with baseline in both groups, but with a larger increase in the atropine group (P<0.05).",['120 patients who received PCTG'],"['control and atropine', 'Atropine', 'saline', 'atropine', 'atropine 0.004\u2009mg/kg intravenously']","['hemodynamic responses', 'HR', 'Trigeminocardiac Reflex-induced Hemodynamic Changes', 'Heart rate (HR) and mean arterial pressure (MAP', 'MAP increased during PCTG', 'MAP', 'incidence of TCR', 'time of skin puncture']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0040995', 'cui_str': 'Structure of trigeminal ganglion'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C2747866', 'cui_str': 'Trigemino-cardiac reflex'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0520853', 'cui_str': 'Increased mean arterial pressure'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0040995', 'cui_str': 'Structure of trigeminal ganglion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}]",120.0,0.0518231,"MAP increased during PCTG compared with baseline in both groups, but with a larger increase in the atropine group (P<0.05).","[{'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Shengjing Hospital of China Medical University.'}, {'ForeName': 'Zhan-Ying', 'Initials': 'ZY', 'LastName': 'Guan', 'Affiliation': 'Department of Anesthesiology, the General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anaesthesiology, Shengjing Hospital of China Medical University.'}, {'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Huang', 'Affiliation': ""Second Department of Neurosurgery, People's Hospital of China Medical University (Liaoning Provical People's Hospital).""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Yan-Feng', 'Initials': 'YF', 'LastName': 'Li', 'Affiliation': ""Second Department of Neurosurgery, People's Hospital of China Medical University (Liaoning Provical People's Hospital).""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Second Department of Neurosurgery, People's Hospital of China Medical University (Liaoning Provical People's Hospital).""}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000702']
2587,31480979,Does testosterone impair men's cognitive empathy? Evidence from two large-scale randomized controlled trials.,"The capacity to infer others' mental states (known as 'mind reading' and 'cognitive empathy') is essential for social interactions across species, and its impairment characterizes psychopathological conditions such as autism spectrum disorder and schizophrenia. Previous studies reported that testosterone administration impaired cognitive empathy in healthy humans, and that a putative biomarker of prenatal testosterone exposure (finger digit ratios) moderated the effect. However, empirical support for the relationship has relied on small sample studies with mixed evidence. We investigate the reliability and generalizability of the relationship in two large-scale double-blind placebo-controlled experiments in young men (n = 243 and n = 400), using two different testosterone administration protocols. We find no evidence that cognitive empathy is impaired by testosterone administration or associated with digit ratios. With an unprecedented combined sample size, these results counter current theories and previous high-profile reports, and demonstrate that previous investigations of this topic have been statistically underpowered.",2019,"The capacity to infer others' mental states (known as 'mind reading' and 'cognitive empathy') is essential for social interactions across species, and its impairment characterizes psychopathological conditions such as autism spectrum disorder and schizophrenia.","['healthy humans', 'young men (n = 243 and n = 400']","['testosterone administration protocols', 'testosterone', 'placebo']",['cognitive empathy'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}]",400.0,0.329516,"The capacity to infer others' mental states (known as 'mind reading' and 'cognitive empathy') is essential for social interactions across species, and its impairment characterizes psychopathological conditions such as autism spectrum disorder and schizophrenia.","[{'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Nadler', 'Affiliation': 'BFI, Toronto, Ontario, Canada.'}, {'ForeName': 'Colin F', 'Initials': 'CF', 'LastName': 'Camerer', 'Affiliation': 'Department of the Humanities and Social Sciences, California Institute of Technology, 1200 E California Boulevard, MC 228-77, Pasadena, CA 91125, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Zava', 'Affiliation': 'ZRT Laboratory, 8605 SW Creekside Place, Beaverton, OR 97008, USA.'}, {'ForeName': 'Triana L', 'Initials': 'TL', 'LastName': 'Ortiz', 'Affiliation': 'Department of Psychology, Nipissing University, 100 College Drive, North Bay, Ontario, Canada P1B 8L7.'}, {'ForeName': 'Neil V', 'Initials': 'NV', 'LastName': 'Watson', 'Affiliation': 'Department of Psychology, Simon Fraser University, 8888 University Drive, Burnaby, British Columbia, Canada V5A 1S6.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Carré', 'Affiliation': 'Department of Psychology, Nipissing University, 100 College Drive, North Bay, Ontario, Canada P1B 8L7.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Nave', 'Affiliation': 'Marketing Department, The Wharton School of the University of Pennsylvania, 3730 Walnut Street, Philadelphia, PA 19104, USA.'}]",Proceedings. Biological sciences,['10.1098/rspb.2019.1062']
2588,31240310,Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial.,"BACKGROUND
Design, conduct, and analysis of randomized clinical trials (RCTs) with time to event end points rely on a variety of assumptions regarding event rates (hazard rates), proportionality of treatment effects (proportional hazards), and differences in intensity and type of events over time and between subgroups.
DESIGN AND METHODS
In this article, we use the experience of the recently reported Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) RCT, which enrolled 8381 patients with human epidermal growth factor 2-positive early breast cancer between June 2007 and July 2011, to highlight how routinely applied statistical assumptions can impact RCT result reporting.
RESULTS AND CONCLUSIONS
We conclude that (i) futility stopping rules are important to protect patient safety, but stopping early for efficacy can be misleading as short-term results may not imply long-term efficacy, (ii) biologically important differences between subgroups may drive clinically different treatment effects and should be taken into account, e.g. by pre-specifying primary subgroup analyses and restricting end points to events which are known to be affected by the targeted therapies, (iii) the usual focus on the Cox model may be misleading if we do not carefully consider non-proportionality of the hazards. The results of the accelerated failure time model illustrate that giving more weight to later events (as in the log rank test) can affect conclusions, (iv) the assumption that accruing additional events will always ensure gain in power needs to be challenged. Changes in hazard rates and hazard ratios over time should be considered, and (v) required family-wise control of type 1 error ≤ 5% in clinical trials with multiple experimental arms discourages investigations designed to answer more than one question.
TRIAL REGISTRATION
clinicaltrials.gov Identifier NCT00490139.",2019,"The results of the accelerated failure time model illustrate that giving more weight to later events (as in the log rank test) can affect conclusions, (iv) the assumption that accruing additional events will always ensure gain in power needs to be challenged.",['8381 patients with human epidermal growth factor 2-positive early breast cancer between June 2007 and July 2011'],[],['hazard rates and hazard ratios'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}]",8381.0,0.0843092,"The results of the accelerated failure time model illustrate that giving more weight to later events (as in the log rank test) can affect conclusions, (iv) the assumption that accruing additional events will always ensure gain in power needs to be challenged.","[{'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Holmes', 'Affiliation': 'Frontier Science (Scotland), Kincraig, Kingussie.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bradbury', 'Affiliation': 'Frontier Science (Scotland), Kincraig, Kingussie.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Williams', 'Affiliation': 'Novartis Pharmaceuticals UK Limited, Frimley, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Korde', 'Affiliation': 'Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'Medical Support Team of the Academic Promoting Team, Institut Jules Bordet, Université Libre de Bruxelles (U.L.B), Brussels.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fumagalli', 'Affiliation': 'Breast International Group (BIG), Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Alliance for Clinical Trials in Oncology (formerly North Central Cancer Treatment Group), Mayo Clinic, Jacksonville.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piccart-Gebhart', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles (U.L.B), Brussels, Belgium.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health, Frontier Science and Technology Research Foundation, Boston, USA. Electronic address: gelber@jimmy.harvard.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz195']
2589,32496526,Evaluation of a Primary Open-Angle Glaucoma Prediction Model Using Long-term Intraocular Pressure Variability Data: A Secondary Analysis of 2 Randomized Clinical Trials.,"Importance
The contribution of long-term intraocular pressure (IOP) variability to the development of primary open-angle glaucoma is still controversial.
Objective
To assess whether long-term IOP variability data improve a prediction model for the development of primary open-angle glaucoma (POAG) in individuals with untreated ocular hypertension.
Design, Setting, and Participants
This post hoc secondary analysis of 2 randomized clinical trials included data from 709 of 819 participants in the observation group of the Ocular Hypertension Treatment Study (OHTS) followed up from February 28, 1994, to June 1, 2002, and 397 of 500 participants in the placebo group of the European Glaucoma Prevention Study (EGPS) followed up from January 1, 1997, to September 30, 2003. Data analyses were completed between January 1, 2019, and March 15, 2020.
Exposures
The original prediction model for the development of POAG included the following baseline factors: age, IOP, central corneal thickness, vertical cup-disc ratio, and pattern SD. This analysis tested whether substitution of baseline IOP with mean follow-up IOP, SD of IOP, maximum IOP, range of IOP, or coefficient of variation IOP would improve predictive accuracy.
Main Outcomes and Measures
The C statistic was used to compare the predictive accuracy of multivariable landmark Cox proportional hazards regression models for the development of POAG.
Results
Data from the OHTS consisted of 97 POAG end points from 709 of 819 participants (416 [58.7%] women; 177 [25.0%] African American and 490 [69.1%] white; mean [SD] age, 55.7 [9.59] years; median [range] follow-up, 6.9 [0.96-8.15] years). Data from the EGPS consisted of 44 POAG end points from 397 of 500 participants in the placebo group (201 [50.1%] women; 397 [100%] white; mean [SD] age, 57.8 [9.76] years; median [range] follow-up, 4.9 [1.45-5.76] years). The C statistic for the original prediction model was 0.741. When a measure of follow-up IOP was substituted for baseline IOP in this prediction model, the C statistics were as follows: mean follow-up IOP, 0.784; maximum IOP, 0.781; SD of IOP, 0.745; range of IOP, 0.741; and coefficient of variation IOP, 0.729. The C statistics in the EGPS were similarly ordered. No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio, and pattern SD, increased the C statistic by more than 0.007 in either cohort.
Conclusions and Relevance
Evidence from the OHTS and the EGPS suggests that long-term variability does not add substantial explanatory power to the prediction model as to which individuals with untreated ocular hypertension will develop POAG.",2020,"No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio, and pattern SD, increased the C statistic by more than 0.007 in either cohort.
","['African American and 490', '819 participants in the observation group of the Ocular Hypertension Treatment Study (OHTS) followed up from February 28, 1994, to June 1, 2002, and 397 of 500 participants in the placebo group of the European Glaucoma Prevention Study (EGPS) followed up from January 1, 1997, to September 30, 2003', 'individuals with untreated ocular hypertension', 'mean [SD] age, 55.7 [9.59] years; median [range] follow-up, 6.9 [0.96-8.15] years', 'group (201 [50.1%] women; 397 [100%] white; mean [SD] age, 57.8 [9.76] years; median [range] follow-up, 4.9 [1.45-5.76] years']","['Primary Open-Angle Glaucoma Prediction Model Using Long-term Intraocular Pressure Variability Data', 'long-term intraocular pressure (IOP', 'placebo']","['C statistic', 'central corneal thickness, vertical cup-disc ratio, and pattern SD', 'IOP variability']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517505', 'cui_str': '1.45'}]","[{'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C1299676', 'cui_str': 'Vertical cup disc ratio'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",,0.230639,"No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio, and pattern SD, increased the C statistic by more than 0.007 in either cohort.
","[{'ForeName': 'Mae O', 'Initials': 'MO', 'LastName': 'Gordon', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Julia Beiser', 'Initials': 'JB', 'LastName': 'Huecker', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Margolis', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kass', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Migliore', 'Affiliation': 'Policlinico di Monza University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Department of Oncology, Istituto di Ricerche Farmacologiche ""Mario Negri,"" Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.1902']
2590,32496604,Response of preterm infants with transient hypothyroxinemia of prematurity to the thyrotropin-releasing hormone stimulation test is characterized by a delayed decrease in thyroid stimulating hormone after the peak.,"OBJECTIVES
We evaluated the response to the thyrotropin-releasing hormone (TRH) stimulation test in very low birth weight (VLBW) infants to elucidate the etiology of transient hypothyroxinemia of prematurity (THOP).
DESIGN AND METHODS
We performed TRH stimulation tests on 43 VLBW infants. Subjects were divided into two groups; a THOP group (N=11; basal TSH < 15 mU/L and basal FT4 ≤ 0.8 ng/dL) and a Non-THOP group (N=32; basal TSH < 15 mU/L and basal FT4 > 0.8 ng/dL). Basal FT4 and FT3 were measured before, and TSH (0, 30, 60, 90, 120, and 180 min) was measured after, the administration of TRH (7 µg/kg). We calculated the ratio of TSH 180 min to THS 0 min as the primary outcome. We also collected data on T3 and rT3 in this study.
RESULTS
In both groups, TSH 30 min values were the highest. However, the ratios of TSH 180 min to THS 0 min in the Non-THOP group and the THOP group were (median [IQR]) 1.3 [1.0-1.7] and 3.0 [1.5-5.3] (p<0.01). No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, p=0.06). However, in the THOP group, rT3 was significantly lower than that of the Non-THOP group (168.0 [148.1-197.0] and 92.9 [74.7-101.6] pg/mL, p<0.01).
CONCLUSIONS
The delayed decrease in the TSH concentration after the peak for the TRH tests and decreased levels of rT3 suggest that the main etiology for THOP is suppression at the level of the hypothalamus, but not inactivation of peripheral thyroid hormone metabolism.",2020,"No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, p=0.06).","['preterm infants with transient hypothyroxinemia of prematurity', 'very low birth weight (VLBW) infants', '43 VLBW infants']","['basal TSH < 15 mU/L and basal FT4 ≤ 0.8 ng/dL) and a Non-THOP group (N=32; basal TSH', 'THOP', 'thyrotropin-releasing hormone (TRH) stimulation test', 'basal FT4']","['Basal FT4 and FT3', 'rT3', 'TSH concentration']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3827793', 'cui_str': 'Transient hypothyroxinaemia of prematurity'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0439342', 'cui_str': 'mU/L'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C3827793', 'cui_str': 'Transient hypothyroxinaemia of prematurity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040162', 'cui_str': 'Thyrotropin-Releasing Hormone'}, {'cui': 'C0201780', 'cui_str': 'Stimulation test'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.0682753,"No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, p=0.06).","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, 54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto-City, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Kogoro', 'Initials': 'K', 'LastName': 'Iwanaga', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, 54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto-City, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsukura', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, 54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto-City, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Fusako', 'Initials': 'F', 'LastName': 'Niwa', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, 54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto-City, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Mukogawa, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Takita', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, 54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto-City, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Kawai', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, 54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto-City, Kyoto, 606-8507, Japan.'}]",Clinical endocrinology,['10.1111/cen.14260']
2591,32139505,Increased dystrophin production with golodirsen in patients with Duchenne muscular dystrophy.,"OBJECTIVE
To report safety, pharmacokinetics, exon 53 skipping, and dystrophin expression in golodirsen-treated patients with Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping.
METHODS
Part 1 was a randomized, double-blind, placebo-controlled, 12-week dose titration of once-weekly golodirsen; part 2 is an ongoing, open-label evaluation. Safety and pharmacokinetics were primary and secondary objectives of part 1. Primary biological outcome measures of part 2 were blinded exon skipping and dystrophin protein production on muscle biopsies (baseline, week 48) evaluated, respectively, using reverse transcription PCR and Western blot and immunohistochemistry.
RESULTS
Twelve patients were randomized to receive golodirsen (n = 8) or placebo (n = 4) in part 1. All from part 1 plus 13 additional patients received 30 mg/kg golodirsen in part 2. Safety findings were consistent with those previously observed in pediatric patients with DMD. Most of the study drug was excreted within 4 hours following administration. A significant increase in exon 53 skipping was associated with ∼16-fold increase over baseline in dystrophin protein expression at week 48, with a mean percent normal dystrophin protein standard of 1.019% (range, 0.09%-4.30%). Sarcolemmal localization of dystrophin was demonstrated by significantly increased dystrophin-positive fibers (week 48, p < 0.001) and a positive correlation (Spearman r = 0.663; p < 0.001) with dystrophin protein change from baseline, measured by Western blot and immunohistochemistry.
CONCLUSION
Golodirsen was well-tolerated; muscle biopsies from golodirsen-treated patients showed increased exon 53 skipping, dystrophin production, and correct dystrophin sarcolemmal localization.
CLINICALTRIALSGOV IDENTIFIER
NCT02310906.
CLASSIFICATION OF EVIDENCE
This study provides Class I evidence that golodirsen is safe and Class IV evidence that it induces exon skipping and novel dystrophin as confirmed by 3 different assays.",2020,"A significant increase in exon 53 skipping was associated with ∼16-fold increase over baseline in dystrophin protein expression at week 48, with a mean percent normal dystrophin protein standard of 1.019% (range, 0.09%-4.30%).","['golodirsen-treated patients with Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping', 'patients with Duchenne muscular dystrophy', 'pediatric patients with DMD', 'Twelve patients']","['placebo', 'golodirsen']","['blinded exon skipping and dystrophin protein production on muscle biopsies (baseline, week 48) evaluated, respectively, using reverse transcription PCR and Western blot and immunohistochemistry', 'dystrophin production', 'dystrophin-positive fibers', 'dystrophin protein expression', 'Safety and pharmacokinetics', 'tolerated; muscle biopsies']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0033268'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035380', 'cui_str': 'Reverse Transcription'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0949466', 'cui_str': 'Western Immunoblot'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",12.0,0.315679,"A significant increase in exon 53 skipping was associated with ∼16-fold increase over baseline in dystrophin protein expression at week 48, with a mean percent normal dystrophin protein standard of 1.019% (range, 0.09%-4.30%).","[{'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'Frank', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Schnell', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Akana', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Saleh H', 'Initials': 'SH', 'LastName': 'El-Husayni', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Cody A', 'Initials': 'CA', 'LastName': 'Desjardins', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Morgan', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Charleston', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Sardone', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Domingos', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dickson', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Straub', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Guglieri', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Servais', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Muntoni', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK. f.muntoni@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009233']
2592,32496624,Clinical and Radiographic Assessment of Circular Versus Triangular cross-section neck Implants in the Posterior Maxilla: A 1-year Randomized Controlled Trial.,"OBJECTIVES
Implants with a triangular neck were recently introduced to limit peri-implant bone loss. The primary objective of this randomized controlled trial was to compare peri-implant bone changes of circular versus triangular cross-section neck implants 1-year after loading. The secondary objectives were to assess buccal hard tissue thickness changes, Pink Esthetic Score (PES) and patient satisfaction.
MATERIAL AND METHODS
Thirty four patients requiring replacement of the single, intercalated missing tooth of healed site for at least 4 months in the posterior maxilla were randomized into 2 groups according to the type of implant. Immediately after surgery and 1 year after final restoration, a cone beam CT (CBCT) was performed to assess proximal bone remodeling and buccal bone thickness. Peri-implant soft tissue health, PES and patient-reported outcome measures (PROMs) were recorded.
RESULTS
No implant loss occurred within the follow-up period. The mean ± SD peri-implant proximal bone loss 1-year after loading was 0.22 ± 0.30 mm for triangular and 0.42 ± 0.67 mm for circular implants necks (p=0.25). Peri-implant bone loss exceeding 2 mm was observed in a single implant in the circular neck group. Buccal bone thickness remained stable and did not differ different between the 2 groups. The peri-implant soft tissue health, PES and patient satisfaction were also comparable.
CONCLUSIONS
Within the limitations of the present study, patient clinical and radiographic outcomes did not differ between triangular and circular cross-section neck implants in the posterior maxilla.",2020,Buccal bone thickness remained stable and did not differ different between the 2 groups.,"['Thirty four patients requiring replacement of the single, intercalated missing tooth of healed site for at least 4 months in the posterior maxilla', 'Posterior Maxilla']","['Circular Versus Triangular cross-section neck Implants', 'circular versus triangular cross-section neck implants 1-year after loading', 'cone beam CT (CBCT']","['implant loss', 'Buccal bone thickness', 'mean ± SD peri-implant proximal bone loss 1-year', 'buccal hard tissue thickness changes, Pink Esthetic Score (PES) and patient satisfaction', 'proximal bone remodeling and buccal bone thickness', 'Peri-implant bone loss']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",34.0,0.145292,Buccal bone thickness remained stable and did not differ different between the 2 groups.,"[{'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Li Manni', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lecloux', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rompen', 'Affiliation': 'University of Liège, Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Aouini', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Shapira', 'Affiliation': 'Department of Periodontology, Hebrew University - Hadassah, Faculty of Dental Medicine, Jerusalem, Israel.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Lambert', 'Affiliation': 'Dental Biomaterials Research Unit, University of Liège, Head of Clinic, Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}]",Clinical oral implants research,['10.1111/clr.13624']
2593,32401626,Combined effects of moderate exercise and short-term fasting on markers of immune function in healthy human subjects.,"This study aimed to investigate the effects of a short-term (36 h) fasting period combined with an acute bout of exercise on markers of immune function and inflammation in healthy human subjects. Fourteen moderately trained male subjects (aged 19-39 yr) participated in a 36-h fasting trial (FA-T), followed by an acute bout of moderate exercise (60% V̇o 2max ). After 1 wk, the same subjects, as their own control, participated in a nonfasting trial (NFA-T) in which they performed an exercise trial of the same duration and intensity. Blood samples were taken before, immediately after, and 1 h after each exercise bout and analyzed for several immunological and metabolic markers. At baseline, fasting subjects showed lower levels of T cell apoptosis, lymphocyte-proliferative responses, IL-6, monocyte chemoattractant protein-1 (MCP-1), insulin, and leptin ( P < 0.05) as well as higher levels of neutrophil oxidative burst and thiobarbituric acid reactive substances (TBARS) than those in the NFA-T ( P < 0.05). After the exercise protocol, fasted subjects revealed higher T cell apoptosis, neutrophil oxidative burst, TBARS, TNFα, and MCP-1 levels as well as lower levels of lymphocyte-proliferative response, IL-6, insulin, and leptin than those in the NFA-T ( P < 0.05). Short-term fasting aggravates perturbations in markers of immune function, and inflammation was induced by an acute moderate-intensity exercise protocol.",2020,"After the exercise protocol, fasted subjects revealed higher T cell apoptosis, neutrophil oxidative burst, TBARS, TNFα, and MCP-1 levels as well as lower levels of lymphocyte-proliferative response, IL-6, insulin, and leptin than those in the NFA-T ( P < 0.05).","['healthy human subjects', 'Fourteen moderately trained male subjects (aged 19-39 yr) participated in a 36-h fasting trial (FA-T), followed by an acute bout of moderate exercise (60% V̇o 2max ']","['short-term (36 h) fasting period combined with an acute bout of exercise', 'moderate exercise and short-term fasting']","['levels of T cell apoptosis, lymphocyte-proliferative responses, IL-6, monocyte chemoattractant protein-1', 'MCP-1), insulin, and leptin', 'higher T cell apoptosis, neutrophil oxidative burst, TBARS, TNFα, and MCP-1 levels as well as lower levels of lymphocyte-proliferative response, IL-6, insulin, and leptin', 'neutrophil oxidative burst and thiobarbituric acid reactive substances (TBARS']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0085416', 'cui_str': 'Oxidative Burst'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",14.0,0.0462555,"After the exercise protocol, fasted subjects revealed higher T cell apoptosis, neutrophil oxidative burst, TBARS, TNFα, and MCP-1 levels as well as lower levels of lymphocyte-proliferative response, IL-6, insulin, and leptin than those in the NFA-T ( P < 0.05).","[{'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Mooren', 'Affiliation': 'Witten/Herdecke University, Faculty of Health/School of Medicine, Witten, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Krueger', 'Affiliation': 'Department of Exercise Physiology and Sports Therapy, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ringseis', 'Affiliation': 'Institute of Animal Nutrition and Nutrition Physiology, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Eder', 'Affiliation': 'Institute of Animal Nutrition and Nutrition Physiology, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Liebisch', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University Hospital, Regensburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Conrad', 'Affiliation': 'Department of Exercise Physiology and Sports Therapy, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Alack', 'Affiliation': 'Department of Exercise Physiology and Sports Therapy, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Hajizadeh Maleki', 'Affiliation': 'Department of Exercise Physiology and Sports Therapy, Justus-Liebig-University, Giessen, Germany.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00341.2019']
2594,32139461,Maternal iron supplementation in pregnancy and asthma in the offspring: follow-up of a randomised trial in Finland.,,2020,,['pregnancy and asthma in the offspring'],['Maternal iron supplementation'],[],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]",[],,0.104416,,"[{'ForeName': 'Seif O', 'Initials': 'SO', 'LastName': 'Shaheen', 'Affiliation': 'Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK s.shaheen@qmul.ac.uk.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Gissler', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Devereux', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Maijaliisa', 'Initials': 'M', 'LastName': 'Erkkola', 'Affiliation': 'Dept of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tarja I', 'Initials': 'TI', 'LastName': 'Kinnunen', 'Affiliation': 'Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Mcardle', 'Affiliation': 'Rowett Institute of Nutrition and Health, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Asthma UK Centre for Applied Research, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Hemminki', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Bright I', 'Initials': 'BI', 'LastName': 'Nwaru', 'Affiliation': 'Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}]",The European respiratory journal,['10.1183/13993003.02335-2019']
2595,32496566,Dose Timing of D-Cycloserine to Augment Exposure Therapy for Social Anxiety Disorder: A Randomized Clinical Trial.,"Importance
Findings suggest that the efficacy of D-cycloserine (DCS) for enhancing exposure therapy may be strongest when administered after sessions marked by low fear at the conclusion of exposure practice. These findings have prompted investigation of DCS dosing tailored to results of exposure sessions.
Objective
To compare tailored postsession DCS administration with presession DCS administration, postsession DCS administration, and placebo augmentation of exposure therapy for social anxiety disorder.
Design, Setting, and Participants
This double-blind randomized clinical trial involved adults with social anxiety disorder enrolled at 3 US university centers. Symptom severity was assessed at baseline, weekly during treatment, and at 1-week and 3-month follow-up. Data analysis was performed from September 2019 to March 2020.
Interventions
Participants completed a 5-session treatment and received pills commensurate with their condition assignment at sessions 2 through 5, which emphasized exposure practice.
Main Outcomes and Measures
Symptom severity was evaluated by the Liebowitz Social Anxiety Scale and Social Phobic Disorders-Severity Form as administered by independent evaluators.
Results
A total of 152 participants were enrolled (mean [SD] age, 29.24 [10.16] years; 84 men [55.26%]). Compared with placebo, presession and postsession conditions showed greater symptom improvement (b = -0.25; 95% CI, -0.37 to -0.13; P < .001; d = 1.07; and b = -0.20; 95% CI, -0.32 to -0.07; P = .002; d = 0.85) and lower symptom severity (b = -0.51; 95% CI, -0.81 to -0.21; P < .001; d = 0.76; and b = -0.49; 95% CI, -0.80 to -0.18; P = .002; d = 0.72) at 3-month follow-up. No differences were found between presession and postsession conditions. The tailored condition showed no advantage over placebo. Compared with the tailored condition, presession and postsession conditions evidenced greater decreases (b = -0.22; 95% CI, -0.34 to -0.10; P < .001; d = 0.94; and b = -0.17, 95% CI, -0.29 to -0.04; P = .008; d = 0.72) and lower symptom severity (b = -0.44, 95% CI, -0.73 to -0.14; P = .004; d = 0.64; and b = -0.41, 95% CI, -0.72 to -0.11; P = .008; d = 0.61) at 3-month follow-up.
Conclusions and Relevance
Administration of DCS enhanced exposure therapy for social anxiety disorder when given before or after the exposure session. However, the study failed to achieve the aim to develop a tailored clinical application.
Trial Registration
ClinicalTrials.gov Identifier: NCT02066792.",2020,"Compared with placebo, presession and postsession conditions showed greater symptom improvement (b = -0.25; 95% CI, -0.37 to -0.13; P < .001;","['Social Anxiety Disorder', 'A total of 152 participants were enrolled (mean [SD] age, 29.24', '10.16] years; 84 men [55.26', 'adults with social anxiety disorder enrolled at 3 US university centers']","['D-cycloserine (DCS', 'D-Cycloserine', '5-session treatment and received pills commensurate with their condition assignment at sessions 2 through 5, which emphasized exposure practice', 'presession DCS administration, postsession DCS administration, and placebo augmentation of exposure therapy', 'DCS enhanced exposure therapy', 'placebo']","['symptom improvement', 'Liebowitz Social Anxiety Scale and Social Phobic Disorders-Severity Form as administered by independent evaluators', 'Symptom severity', 'lower symptom severity']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517518', 'cui_str': '10.16'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",152.0,0.228555,"Compared with placebo, presession and postsession conditions showed greater symptom improvement (b = -0.25; 95% CI, -0.37 to -0.13; P < .001;","[{'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Institute for Mental Health Research, Department of Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Pollack', 'Affiliation': 'Department of Psychiatry, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, Texas.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Dowd', 'Affiliation': 'Department of Psychiatry, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Christina D', 'Initials': 'CD', 'LastName': 'Dutcher', 'Affiliation': 'Institute for Mental Health Research, Department of Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Witcraft', 'Affiliation': 'Institute for Mental Health Research, Department of Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'Institute for Mental Health Research, Department of Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Curtiss', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Andrews', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, Texas.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Kind', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Conroy', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Stefan G', 'Initials': 'SG', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6777']
2596,32130178,A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.,"BACKGROUND
HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low.
OBJECTIVE
The aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States.
METHODS
In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription.
RESULTS
Participant recruitment began in January 2020.
CONCLUSIONS
This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/16231.",2020,"In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM.","['men who have sex with men (MSM', 'southern United States', 'three southern US cities', 'Participant recruitment began in January 2020', 'Men', '657 men']","['PrEP', 'full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health', 'HealthMindr']","['Increase Pre-Exposure Prophylaxis Uptake', 'PrEP uptake']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0566217', 'cui_str': 'Does ask questions (finding)'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]",657.0,0.20504,"In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM.","[{'ForeName': 'Jeb', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dominguez', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'Department of Systems, Populations and Leadership, School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Joanne D', 'Initials': 'JD', 'LastName': 'Stekler', 'Affiliation': 'Division of Allergy & Infectious Diseases, School of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Castel', 'Affiliation': 'Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'Leandro A', 'Initials': 'LA', 'LastName': 'Mena', 'Affiliation': 'Department of Population Health Science, John D Bower School of Population Health, University of Mississippi Medical Center, Jackson, MS, United States.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Jenness', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Siegler', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}]",JMIR research protocols,['10.2196/16231']
2597,32496600,Can a participatory organizational intervention improve social capital and organizational readiness to change? Cluster randomized controlled trial at five Danish hospitals.,"AIM
This study investigates the effect of a participatory organizational intervention on social capital and organizational readiness for change.
DESIGN
Cluster randomized controlled trial METHODS: In 2016, twenty-seven departments from five hospitals in Denmark were randomly allocated at the department level to one year of participatory intervention (14 clusters, 316 healthcare workers) or a control group (13 clusters, 309 healthcare workers). The participatory intervention consisted of 2x2 hour workshops where managers, 2-5 healthcare workers from each department and the hospital's health and safety staff, developed action plans for implementing solutions for improving the use of assistive devices at the department throughout the one-year intervention period. Workplace social capital: (1) within teams (bonding); (2) between teams and nearest leaders (linking A); and (3) between teams and distant leaders (linking B) and organizational readiness for change were measured using questionnaires at baseline, 6 and 12 months.
RESULTS
No group by time interaction occurred for any of the outcome measures. However, explorative post hoc analysis showed within-group improvements in bonding and linking B social capital and Organizational readiness for change following the participatory intervention.
CONCLUSION
Participatory organizational interventions may improve social capital within teams and between teams and distant leaderes and Organizational readiness for change.
IMPACT
Implementing participatory interventions at the workplace may be a cost-effective strategy as they provide additional benefits, e.g. increased social capital and improved organizational readiness for change, that exceed the primary outcome of the intervention.",2020,No group by time interaction occurred for any of the outcome measures.,"['In 2016, twenty-seven departments from five hospitals in Denmark were randomly allocated at the department level to one year of participatory intervention (14 clusters, 316 healthcare workers) or a control group (13 clusters, 309 healthcare workers']","['Participatory organizational interventions', 'participatory organizational intervention']","['social capital and organizational readiness', 'time interaction', 'bonding and linking B social capital and Organizational readiness']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1510639', 'cui_str': 'Social Capital'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.0589774,No group by time interaction occurred for any of the outcome measures.,"[{'ForeName': 'Markus D', 'Initials': 'MD', 'LastName': 'Jakobsen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clausen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}]",Journal of advanced nursing,['10.1111/jan.14441']
2598,31633313,Baseline Psychosocial and Demographic Factors Associated with Study Attrition and 12-Month Weight Gain in the DIETFITS Trial.,"OBJECTIVE
The purpose of this study was to examine correlates of failure-trial attrition and weight gain-in a randomized clinical weight-loss trial.
METHODS
The Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) trial included 609 adults (18-50 years; BMI 28-40). Participants were randomized to a 12-month healthy low-fat or healthy low-carbohydrate diet for weight loss. At baseline, participants completed psychosocial, demographic, and anthropometric measures. Stepwise logistic regressions identified baseline factors associated with (1) study attrition and (2) among trial completers, weight gain at 12 months.
RESULTS
Having higher baseline food addiction and self-efficacy was linked to treatment failure. Being younger, not having a college education, having higher outcome expectations and quality of life, and having lower social functioning and self-control increased the odds of trial attrition. Identifying as other than non-Hispanic white; not being married or cohabitating; having higher cognitive restraint and self-control; and having lower amotivation, family encouragement, and physical limitations increased the odds of gaining weight by treatment's end.
CONCLUSIONS
Participants' baseline psychosocial and demographic factors may support or impede successful weight loss. Trialists should attend to these factors when designing treatments in order to promote participants' likelihood of completing the trial and achieving their weight-loss goals.",2019,Having higher baseline food addiction and self-efficacy was linked to treatment failure.,['609 adults (18-50 years; BMI 28-40'],"['healthy low-fat or healthy low-carbohydrate diet for weight loss', 'Diet Intervention']","['weight gain', 'Study Attrition and 12-Month Weight Gain', 'Baseline Psychosocial and Demographic Factors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}]",609.0,0.0533071,Having higher baseline food addiction and self-efficacy was linked to treatment failure.,"[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Fielding-Singh', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Patel', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22650']
2599,32493359,Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy for teenagers with severe obesity - TEEN-BEST: study protocol of a multicenter randomized controlled trial.,"BACKGROUND
Recent data support the use of bariatric surgery in adolescents with severe obesity following unsuccessful non-surgical treatments. Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) have demonstrated reasonably similar weight loss and reduction of obesity related comorbidities in randomized trials in adults. SG has internationally become the most commonly used procedure in adolescents, yet long-term outcome data are lacking. No randomized controlled trial comparing SG and RYGB has been performed in adolescents.
OBJECTIVE
Determine whether SG is non-inferior to RYGB in terms of total body weight (TBW) loss in adolescents with severe obesity.
METHODS
A multicenter randomized controlled non-inferiority trial. Two hundred sixty-four adolescents aged 13-17 (Tanner stage ≥IV) with severe obesity (corrected for age and sex) will be included. Adolescents agreeing to participate will be randomized to either RYGB or SG. The primary outcome is the proportion of participants achieving 20% TBW loss at 3 years postoperatively. Secondary outcomes include (i) change in body weight, body mass index (BMI) and BMI standard deviation score, (ii) incidence of adverse health events and need for additional surgical intervention, (iii) resolution of obesity-related comorbidities, (iv) prevalence of cardio metabolic risk factor measures, (v) bone health measures and incidence of bone fractures, (vi) quality of life including psychosocial health, patient satisfaction and educational attainment and (vii) body composition. Follow-up will extend into the long term.
RESULTS
Not applicable.
DISCUSSION
This study will, to our knowledge, be the first randomized controlled trial comparing SG and RYGB in adolescents with severe obesity.
TRIAL REGISTRATION
The trial is registered at the Netherlands Trial Register on July 26th, 2018 - NTR7191 - https://www.trialregister.nl/trial/7191 (protocol version 5.0 - February 3th 2020).",2020,"OBJECTIVE
Determine whether SG is non-inferior to RYGB in terms of total body weight","['Netherlands Trial Register on July 26th, 2018 - NTR7191 - https://www.trialregister.nl/trial/7191 (protocol version 5.0 - February 3th 2020', 'adolescents', 'adolescents with severe obesity following unsuccessful non-surgical treatments', 'teenagers with severe obesity - TEEN-BEST', 'Two hundred sixty-four adolescents aged 13-17 (Tanner stage ≥IV) with severe obesity (corrected for age and sex', 'adolescents with severe obesity']","['Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB', 'RYGB or SG', 'SG and RYGB', 'bariatric surgery', 'Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy', 'SG']","['proportion of participants achieving 20% TBW loss', 'total body weight', 'TBW) loss', 'i) change in body weight, body mass index (BMI) and BMI standard deviation score, (ii) incidence of adverse health events and need for additional surgical intervention, (iii) resolution of obesity-related comorbidities, (iv) prevalence of cardio metabolic risk factor measures, (v) bone health measures and incidence of bone fractures, (vi) quality of life including psychosocial health, patient satisfaction and educational attainment and (vii) body composition']","[{'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0335730', 'cui_str': 'Tanner'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",264.0,0.176438,"OBJECTIVE
Determine whether SG is non-inferior to RYGB in terms of total body weight","[{'ForeName': 'Daniëlle S', 'Initials': 'DS', 'LastName': 'Bonouvrie', 'Affiliation': 'Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands. danielle.bonouvrie@mmc.nl.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Department of Gastrosurgical Research and Education - Institute of Clinical Sciences, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Wouter K G', 'Initials': 'WKG', 'LastName': 'Leclercq', 'Affiliation': 'Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands.'}, {'ForeName': 'Edgar G A H', 'Initials': 'EGAH', 'LastName': 'van Mil', 'Affiliation': ""Department of Pediatrics - Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'Arijan A P M', 'Initials': 'AAPM', 'LastName': 'Luijten', 'Affiliation': 'Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Hazebroek', 'Affiliation': 'Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Anita C E', 'Initials': 'ACE', 'LastName': 'Vreugdenhil', 'Affiliation': 'Department of Pediatrics, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Olbers', 'Affiliation': 'Department of Biomedical and Clinical Sciences and Wallenberg Center for Molecular Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'François M H', 'Initials': 'FMH', 'LastName': 'van Dielen', 'Affiliation': 'Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands.'}]",BMC surgery,['10.1186/s12893-020-00778-9']
2600,31326680,Design and rationale of a pragmatic trial integrating routine screening for atrial fibrillation at primary care visits: The VITAL-AF trial.,"Given the preventable morbidity and mortality associated with atrial fibrillation (AF), increased awareness of undiagnosed AF, and advances in mobile electrocardiogram (ECG) technology, there is a critical need to assess the effectiveness of using such technology to routinely screen for AF in clinical practice. VITAL-AF is a pragmatic trial that will test whether screening for AF using a single-lead handheld ECG in individuals 65 years or older during primary care visits will lead to an increased rate of AF detection. The study is a cluster-randomized trial, with 8 primary care practices randomized to AF screening and 8 primary care practices randomized to usual care. We anticipate studying approximately 16,000 patients in each arm. During the 1-year enrollment period, practice medical assistants will screen eligible patients who agree to participate during office visits using a single-lead ECG device. Automated screening results are documented in the electronic health record, and patients can discuss screening results with their provider during the scheduled visit. All single-lead ECGs are overread by a cardiologist. Screen-detected AF is managed at the discretion of the patient's physician. The primary study end point is incident AF during the screening period. Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start. Outcomes are ascertained based on electronic health record documentation and are manually adjudicated. The results of this pragmatic trial may help identify a model for widespread adoption of AF screening as part of routine clinical practice.",2019,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","['atrial fibrillation at primary care visits', '16,000 patients in each arm', 'individuals 65 years or older during primary care visits', 'eligible patients who agree to participate during office visits using a single-lead ECG device']",['AF screening'],"['new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0527347,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Trisini Lipsanopoulos', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Leila H', 'Initials': 'LH', 'LastName': 'Borowsky', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wyliena', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Ellinor', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Singer', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lubitz', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA. Electronic address: slubitz@mgh.harvard.edu.'}]",American heart journal,['10.1016/j.ahj.2019.06.011']
2601,32493335,Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial.,"BACKGROUND
The EXAMINE trial tested the efficacy and safety of alogliptin, an inhibitor of dipeptidyl peptidase 4, compared with placebo in 5380 patients with type 2 diabetes and a recent acute coronary syndrome. Because alogliptin is cleared by the kidney, patients were stratified according to screening renal function within two independently randomized strata: (1) estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73m 2 and (2) eGFR < 60 ml/min/1.73m 2 . We aim to assess the efficacy and safety of alogliptin vs. placebo according to the renal function strata.
METHODS
Cox-proportional hazard models with an interaction term by renal function strata were used. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke.
RESULTS
Patient characteristics were balanced within each renal function strata. In total, 3946 patients were randomized within the eGFR ≥ 60 stratum, and 1434 patients within the eGFR < 60 stratum. The effect of alogliptin was modified by the renal function strata.
PRIMARY OUTCOME
eGFR ≥ 60 HR = 0.81, 95%CI, 0.65-0.99, and eGFR < 60 HR = 1.20, 95%CI, 0.95-1.53; interaction p = 0.014. Cardiovascular death: eGFR ≥ 60 HR = 0.61, 95%CI, 0.42-0.88, and eGFR < 60 HR = 1.16, 95%CI, 0.82-1.65; interaction p = 0.013. Non-fatal MI: eGFR ≥ 60 HR = 0.86, 95%CI, 0.66-1.13, and eGFR < 60 HR = 1.48, 95%CI, 1.07-2.06; interaction p = 0.013.
CONCLUSIONS
Alogliptin may benefit patients with eGFR ≥ 60, but may be detrimental to patients with eGFR < 60 ml/min/1.73m 2 . These hypothesis-generating findings require further validation to assess the potential benefit and risk of alogliptin across the renal function spectrum among patients with type 2 diabetes and a recent acute coronary syndrome.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT00968708.",2020,"Cardiovascular death: eGFR ≥ 60 HR = 0.61, 95%CI, 0.42-0.88, and eGFR < 60 HR = 1.16, 95%CI, 0.82-1.65; interaction p = 0.013. Non-fatal MI: eGFR ≥ 60 HR = 0.86, 95%CI, 0.66-1.13, and eGFR < 60 HR = 1.48, 95%CI, 1.07-2.06; interaction p = 0.013.
","['5380 patients with type 2 diabetes and a recent acute coronary syndrome', '3946 patients were randomized within the eGFR ≥\u200960 stratum, and 1434 patients within the eGFR <\u200960 stratum', 'patients with type 2 diabetes and a recent acute coronary syndrome', 'patients with type 2 diabetes']","['alogliptin', 'eGFR', 'alogliptin vs. placebo', 'Alogliptin', 'placebo']","['efficacy and safety', 'composite of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",5380.0,0.140347,"Cardiovascular death: eGFR ≥ 60 HR = 0.61, 95%CI, 0.42-0.88, and eGFR < 60 HR = 1.16, 95%CI, 0.82-1.65; interaction p = 0.013. Non-fatal MI: eGFR ≥ 60 HR = 0.86, 95%CI, 0.66-1.13, and eGFR < 60 HR = 1.48, 95%CI, 1.07-2.06; interaction p = 0.013.
","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France. j.ferreira@chru-nancy.fr.""}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'Cytel Corportation, Cambridge, MA, USA.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Cardiology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France.""}]",BMC medicine,['10.1186/s12916-020-01616-8']
2602,32493344,"Linagliptin, when compared to placebo, improves CD34+ve endothelial progenitor cells in type 2 diabetes subjects with chronic kidney disease taking metformin and/or insulin: a randomized controlled trial.","BACKGROUND
Endothelial Progenitor cells (EPCs) has been shown to be dysfunctional in both type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) leading to poor regeneration of endothelium and renal perfusion. EPCs have been shown to be a robust cardiovascular disease (CVD) risk indicator. Cellular mechanisms of DPP4 inhibitors such as linagliptin (LG) on CVD risk, in patients with T2DM with established CKD has not been established. Linagliptin, a DPP4 inhibitor when added to insulin, metformin or both may improve endothelial dysfunction in a diabetic kidney disease (DKD) population.
METHODS
31 subjects taking metformin and/or Insulin were enrolled in this 12 weeks, double blind, randomized placebo matched trial, with 5 mg LG compared to placebo. Type 2 diabetes subjects (30-70 years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included. CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition were measured. Data were collected at week 0, 6 and 12. A mixed model regression analysis was done with p value < 0.05 considered significant.
RESULTS
A double positive CD34/CD184 cell count had a statistically significant increase (p < 0.02) as determined by flow cytometry in LG group where CD184 is SDF1a cell surface receptor. Though mRNA differences in CD34+ve was more pronounced CD34- cell mRNA analysis showed increase in antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3). Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group. A reduction in LDL: HDL ratio was noted in treatment group (p < 0.04). Urinary exosome protein examining podocyte health (podocalyxin, Wilms tumor and nephrin) showed reduction or improvement.
CONCLUSIONS
In DKD subjects, Linagliptin promotes an increase in CXCR4 expression on CD34 + progenitor cells with a concomitant improvement in vascular and renal parameters at 12 weeks. Trial Registration Number NCT02467478 Date of Registration: 06/08/2015.",2020,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"['patients with T2DM with established CKD', 'Type 2 diabetes subjects (30-70\xa0years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included', '31 subjects taking', 'type 2 diabetes subjects with chronic kidney disease taking']","['Linagliptin', 'linagliptin (LG', 'metformin', 'Endothelial Progenitor cells (EPCs', 'metformin and/or insulin', 'placebo']","['Arterial stiffness measures such as augmentation Index (AI', 'LDL: HDL ratio', 'endothelial dysfunction', 'CXCR4 expression', 'CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition', 'pulse wave analysis (PWV', 'antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3', 'CD34+ve endothelial progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C2316401', 'cui_str': 'Chronic kidney disease stage 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0232901', 'cui_str': 'Migratory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0968147', 'cui_str': 'superoxide dismutase 2'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}]",,0.207918,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"[{'ForeName': 'Hassan B', 'Initials': 'HB', 'LastName': 'Awal', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Seshagiri Rao', 'Initials': 'SR', 'LastName': 'Nandula', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Cleyton C', 'Initials': 'CC', 'LastName': 'Domingues', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Dore', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Nabanita', 'Initials': 'N', 'LastName': 'Kundu', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Beda', 'Initials': 'B', 'LastName': 'Brichacek', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fakhri', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Elzarki', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Neeki', 'Initials': 'N', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Safai', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Magan', 'Initials': 'M', 'LastName': 'Fosso', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Amdur', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA. ssen1@gwu.edu.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01046-z']
2603,32493460,"A short, animated video to improve good COVID-19 hygiene practices: a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES
Entertainment-education (E-E) media can improve behavioral intent toward health-related practices. In the era of COVID-19, millions of people can be reached by E-E media without requiring any physical contact. We have designed a short, wordless, animated video about COVID-19 hygiene practices-such as social distancing and frequent hand washing-that can be rapidly distributed through social media channels to a global audience. The E-E video's effectiveness, however, remains unclear. The study aims to achieve the following objectives. To: 1.Quantify people's interest in watching a short, animated video about COVID-19 hygiene (abbreviated to CoVideo).2.Establish the CoVideo's effectiveness in increasing behavioural intent toward COVID-19 hygiene.3.Establish the CoVideo's effectiveness in improving COVID-19 hygiene knowledge.
TRIAL DESIGN
The present study is a multi-site, parallel group, randomized controlled trial (RCT) comparing the effectiveness of the CoVideo against an attention placebo control (APC) video or no video. The trial has an intervention arm (CoVideo), placebo arm (APC), and control arm (no video). Nested in each trial arm is a list experiment and questionnaire survey, with the following ordering. Arm 1: the CoVideo, list experiment, and questionnaire survey. Arm 2: the APC video, list experiment, questionnaire survey, and CoVideo. Arm 3: the list experiment, questionnaire survey, and CoVideo. For each list experiment, participants will be randomized to a control or treatment group. The control group will receive a list of five items and the treatment group will receive the same five items plus one item about COVID-19 hygiene. We will use the list experiment to reduce response bias associated with socially desirable answers to COVID-19 questions. The questionnaire survey will include items about the participant's age, sex, country of residence, highest education, and knowledge of COVID-19 spread. After completing the list experiment and questionnaire survey, participants in Arms 2 and 3 will receive the CoVideo to ensure post-trial access to treatment.
PARTICIPANTS
This will be an online study setting. We will use Prolific Academic (ProA: https://www.prolific.co) to recruit participants and host our study on the Gorilla™ platform (www.gorilla.sc). To be eligible, participants must be between the age of 18 and 59 years (male, female, or other) and have current residence in the United States, the United Kingdom, Germany, Spain, Mexico, or France. Participants will be excluded from the study if they cannot speak English, German, French, or Spanish (since the instructions and survey questions will be available in these 4 languages only).
INTERVENTION AND COMPARATOR
The intervention is an E-E video about COVID-19 hygiene (CoVideo). Developed by our co-author (MA) for Stanford Medicine, the CoVideo is animated with sound effects, and has no words, speech, or text. The CoVideo shows how the novel coronavirus is spread (airborne, physical contact) and summarizes the public's response to the COVID-19 outbreak. Key components of the CoVideo are the promotion of five hygiene practices: i) social distancing and avoiding group gatherings, ii) frequently washing hands with soap and water or sanitizer, iii) cleaning surfaces at home (e.g., kitchen counters), iv) not sharing eating utensils, and v) avoidance of stockpiling essential goods (such as toilet paper and face masks). The CoVideo, which was designed for universal reach and optimized for release on social media channels, can be viewed at https://www.youtube.com/watch?v=rAj38E7vrS8. The comparators are an APC video (Arm 2) or no video (Arm 3). The APC video is similar in style to the CoVideo; it is also animated with a duration of 2.30 minutes, has sound effects but no words, speech, or text. The video message is about how small choices become actions, which become habits, which become a way of life. It is available at https://www.youtube.com/watch?v=_HEnohs6yYw. Each list experiment will have a control list as the comparator. The control list is needed to measure the prevalence of behavioral intent toward COVID-19 hygiene.
MAIN OUTCOMES
This study will measure primary and secondary outcomes related to COVID-19 hygiene. By hygiene, we mean the adoption of behaviors or practices that reduce the chances of being infected or spreading COVID-19. As our primary outcome, we will measure changes in behavioral intent toward five hygiene practices: social distancing, washing hands, cleaning household surfaces, not sharing eating utensils, and not stockpiling essential goods. As a secondary outcome, we will measure knowledge about behaviors that can prevent the spread of COVID-19.
RANDOMIZATION
Using a web-based randomization algorithm, Gorilla will randomly allocate participants to the intervention (CoVideo), placebo (APC), or control (no video) arm (sequence generation) at a 1:1:1 ratio. Within each trial arm, Gorilla will randomly allocate participants at a 1:1 ratio to the control or treatment group. Items in the lists will be randomly ordered to avoid order effects. The presentation order of the list experiments will also be randomized.
BLINDING
Because ProA handles the interaction between the study investigators and participants, the participants will be completely anonymous to the study investigators. The outcome measures will be self-reported and submitted anonymously. All persons in the study team will be blinded to the group allocation.
NUMBERS TO BE RANDOMIZED
The Gorilla algorithm will randomize 6,700 participants to each trial arm, giving a total sample size of 20,100.
TRIAL STATUS
The protocol version number is 1.0 and the date is 18 May 2020. Recruitment is expected to end by 22 June 2020. Thus far, the study investigators have recruited 2,500 participants on ProA. Of these participants, 800 have completed the study on the Gorilla platform.
TRIAL REGISTRATION
The study and its outcomes were registered at the German Clinical Trials Register (www.drks.de) on May 12 th , 2020, protocol number: #DRKS00021582. The study was registered before any data was collected.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"As our primary outcome, we will measure changes in behavioral intent toward five hygiene practices: social distancing, washing hands, cleaning household surfaces, not sharing eating utensils, and not stockpiling essential goods.","['6,700 participants to each trial arm, giving a total sample size of 20,100', '2,500 participants on ProA. Of these participants, 800 have completed the study on the Gorilla platform', 'participants must be between the age of 18 and 59 years (male, female, or other) and have current residence in the United States, the United Kingdom, Germany, Spain, Mexico, or France']","['placebo (APC), or control (no video) arm (sequence generation', 'CoVideo against an attention placebo control (APC) video or no video', 'placebo arm (APC), and control arm (no video', 'social distancing and avoiding group gatherings, ii) frequently washing hands with soap and water or sanitizer, iii) cleaning surfaces at home (e.g., kitchen counters), iv) not sharing eating utensils, and v) avoidance of stockpiling essential goods (such as toilet paper and face masks']","['behavioral intent toward five hygiene practices: social distancing, washing hands, cleaning household surfaces, not sharing eating utensils, and not stockpiling essential goods', 'good COVID-19 hygiene practices', 'knowledge about behaviors that can prevent the spread of COVID-19']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018090', 'cui_str': 'Gorilla gorilla'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0700382', 'cui_str': 'Washing hands'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0079260', 'cui_str': 'Eating Utensils'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0700382', 'cui_str': 'Washing hands'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0079260', 'cui_str': 'Eating Utensils'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}]",,0.0892525,"As our primary outcome, we will measure changes in behavioral intent toward five hygiene practices: social distancing, washing hands, cleaning household surfaces, not sharing eating utensils, and not stockpiling essential goods.","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vandormael', 'Affiliation': 'Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany. alain.vandormael@uni-heidelberg.de.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Adam', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Merlin', 'Initials': 'M', 'LastName': 'Greuel', 'Affiliation': 'Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.'}]",Trials,['10.1186/s13063-020-04449-1']
2604,32179181,Efficacy of strategies to increase participation in cervical cancer screening: GPs offering self-sampling kits for HPV testing versus recommendations to have a pap smear taken - A randomised controlled trial.,,2020,,['cervical cancer screening'],[],[],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],[],,0.0359161,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Peeters', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cornet', 'Affiliation': 'De Groet, General Practice Oetingen, Gooik, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Devroey', 'Affiliation': 'General Medicine, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arbyn', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium. Electronic address: marc.arbyn@sciensano.be.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100194']
2605,32199850,Adding Alirocumab to Rosuvastatin Helps Reduce the Vulnerability of Thin-Cap Fibroatheroma: An ALTAIR Trial Report.,,2020,,[],['Rosuvastatin'],['Vulnerability of Thin-Cap Fibroatheroma'],[],"[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C2936351', 'cui_str': 'Fibroatheromatous Plaques'}]",,0.028691,,"[{'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Sugizaki', 'Affiliation': ''}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': ''}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kawamori', 'Affiliation': ''}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Toba', 'Affiliation': ''}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Nagano', 'Affiliation': ''}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Tsukiyama', 'Affiliation': ''}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Yanaka', 'Affiliation': ''}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Nagasawa', 'Affiliation': ''}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Onishi', 'Affiliation': ''}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Takeshige', 'Affiliation': ''}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': ''}, {'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Matsuoka', 'Affiliation': ''}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Tanimura', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': ''}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Fukuyama', 'Affiliation': ''}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Shinke', 'Affiliation': ''}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Ishida', 'Affiliation': ''}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Hirata', 'Affiliation': ''}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2020.01.021']
2606,32493398,CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins.,"BACKGROUND
Several modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates. Despite this, there is the possibility of thermal injury to surrounding structures. The recently introduced cyanoacrylate closure is also considered to be a good alternative and the risk of injury to surrounding structures is minimal. The purpose of this study is to demonstrate the non-inferiority of cyanoacrylate closure with the VenaSeal™ closure system compared to surgical stripping in terms of clinical outcomes for the treatment of incompetent great saphenous veins.
METHODS/DESIGN
This is an open-label, multicenter, prospective, randomized controlled trial evaluating the non-inferior clinical outcomes of cyanoacrylate closure compared to surgical stripping for the treatment of incompetent saphenous veins. After baseline measurements, participants will be randomly allocated into either the cyanoacrylate closure group or the surgical-stripping group. The primary endpoint of the study is the complete closure rate of the target vein in the cyanoacrylate closure group, and the absence of venous reflux or residual venous tissue after surgical stripping in the surgical-stripping group. These endpoints will be measured by Doppler ultrasound performed by qualified vascular technologists or investigators at 3 months after treatment. Secondary outcomes include perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates during the 24-month follow-up period.
DISCUSSION
This multicenter randomized controlled trial is designed to show non-inferiority in terms of complete closure rate of cyanoacrylate compared to surgical stripping for the treatment of incompetent saphenous veins.
TRIAL REGISTRATION
Clinical Research Information Service (CRIS), ID: KCT0003203. Registered on 20 September 2018.",2020,"Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates.",['incompetent saphenous veins'],"['CASS (CyanoAcrylate closure versus Surgical Stripping', 'cyanoacrylate', 'Endovenous thermal ablation', 'cyanoacrylate closure group or the surgical-stripping group', 'cyanoacrylate closure and surgical stripping', 'cyanoacrylate closure', 'cyanoacrylate closure with the VenaSeal™ closure system', 'ligation and stripping of the saphenous vein', 'surgical stripping']","['absence of venous reflux or residual venous tissue after surgical stripping', 'perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates', 'complete closure rate of the target vein']","[{'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}]","[{'cui': 'C0643514', 'cui_str': '6-chloropenicillanic acid S-sulfoxide'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0618221,"Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates.","[{'ForeName': 'Sungsin', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyung Sub', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Taeseung', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Seung Jae', 'Initials': 'SJ', 'LastName': 'Byun', 'Affiliation': 'Department of Surgery, Wonkwang University Hospital, Wonkwang University School of Medicine, Iksan, South Korea.'}, {'ForeName': 'Woo-Sung', 'Initials': 'WS', 'LastName': 'Yun', 'Affiliation': 'Department of Surgery, Yeungnam University Medical Center, Yeungnam University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Shin-Seok', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery, Yeungnam University Medical Center, Yeungnam University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Hyangkyoung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chung-Ang University Hospital, Chung-Ang School of Medicine, Dongjak-gu, South Korea.'}, {'ForeName': 'Woo-Shik', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jin Hyun', 'Initials': 'JH', 'LastName': 'Joh', 'Affiliation': 'Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'In Mok', 'Initials': 'IM', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, 07061 20 Boramae-ro, Dongjak-gu, Seoul, South Korea. sboy5240@gmail.com.'}]",Trials,['10.1186/s13063-020-04393-0']
2607,32493411,Overall adjustment acupuncture for postmenopausal osteoporosis (PMOP): a study protocol for a randomized sham-controlled trial.,"BACKGROUND
Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have side effects. Acupuncture is widely used for treating osteoporotic postmenopausal women because it is non-invasive and has fewer side effects, but the powerful clinical evidence for its efficacy remains insufficient. Our study intends to explore the effect of overall adjustment acupuncture (OA) in the treatment of postmenopausal osteoporosis (PMOP).
METHODS/DESIGN
This study is a randomized, sham-controlled, patient- and assessor-blinded trial and aims to evaluate the effect of OA in women with PMOP. We will recruit 104 women aged 45-70 years with a diagnosis of PMOP. Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group. Both groups will receive real herbal medicine treatment as a basic treatment twice a day for 3 months, the OA group receives real acupuncture treatment and the SA group receives placebo acupuncture treatment (non-penetrating, sham skin-needle therapy, sham cupping). All patients will receive acupuncture treatment twice per week for 3 months. The primary outcome is bone mineral density (BMD) and the secondary outcomes include estradiol (E2), follicle-stimulating hormone (FSH), bone gla protein (BGP), bone alkaline phosphatase (BALP), total antioxidant capacity (TAC), advanced oxidation protein products (AOPP), PPARγ, β-catenin, FoxO3a levels, visual analog pain scale score (VAS), Traditional Chinese medicine (TCM) syndrome scores and quality of daily life score (QOL). Outcome measures will be collected at baseline, middle of the treatment (1.5 months), the end of treatment (3 months). The present protocol followed the SPIRIT guidelines and fulfills the SPIRIT Checklist.
CONCLUSION
This study will be conducted to compare the efficacy of OA versus SA. This trial should help to evaluate whether OA can effectively prevent and treat PMOP by improving the estrogen levels of postmenopausal women. The mechanism is to improve the imbalance of osteogenic differentiation and lipogenesis of bone-marrow cells under oxidative stress.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ID: ChiCTR1800017581. Registered on 5 August 2018. URL: http://www.chictr.org.cn.",2020,Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group.,"['postmenopausal osteoporosis (PMOP', 'postmenopausal women', 'osteoporotic postmenopausal women', 'women with PMOP', '104 women aged 45-70\u2009years with a diagnosis of PMOP']","['acupuncture', 'acupuncture (OA', 'real herbal medicine treatment', 'OA group receives real acupuncture treatment and the SA group receives placebo acupuncture treatment (non-penetrating, sham skin-needle therapy, sham cupping', 'Acupuncture', 'OA group and the sham acupuncture (SA', 'OA versus SA', 'OA']","['bone mineral density (BMD) and the secondary outcomes include estradiol (E2), follicle-stimulating hormone (FSH), bone gla protein (BGP), bone alkaline phosphatase (BALP), total antioxidant capacity (TAC), advanced oxidation protein products (AOPP), PPARγ, β-catenin, FoxO3a levels, visual analog pain scale score (VAS), Traditional Chinese medicine (TCM) syndrome scores and quality of daily life score (QOL']","[{'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C1333633', 'cui_str': 'FOXO3A protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",104.0,0.305839,Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group.,"[{'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Ren', 'Affiliation': 'Nanjing University of Chinese Medicine, No.138 Xianlin Road, Nanjing, 210046, China.'}, {'ForeName': 'Y F', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Ao', 'Affiliation': 'The First Affiliated Hospital of Dali University, No. 32 Jiashibo Road, Dali, 671000, Yunnan Province, China.'}, {'ForeName': 'H X', 'Initials': 'HX', 'LastName': 'Chen', 'Affiliation': 'School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture, Kunming Municipal Hospital of Traditional Chinese Medicine, 25 Dongfeng Road, Panlong District, Kunming, 650011, Yunnan Province, China.'}, {'ForeName': 'M X', 'Initials': 'MX', 'LastName': 'Lai', 'Affiliation': 'School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital of Dali University, No. 32 Jiashibo Road, Dali, 671000, Yunnan Province, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital of Yunnan University of Chinese Medicine, No.120 Guanghua Road, Wuhua District, Kunming, 650032, Yunnan Province, China. kmzhaorong@qq.com.'}]",Trials,['10.1186/s13063-020-04435-7']
2608,32493447,Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
Comparison of the effect of hydroxychloroquine with placebo to prevent infection from the COVID -19 virus among healthcare professionals TRIAL DESIGN: Single centre, 2-arm, double-blind randomised (ratio 1:1) placebo-controlled trial PARTICIPANTS: Treatment staff who are in contact with patients and have at least 3 shifts a week in Arash hospital affiliated with Tehran University of Medical Sciences, in Iran and who consent to participate in the study. Exclusion criteria include: History of COVID -19 virus infection, clinical symptoms such as fever, nausea, dyspnea and myalgia in the past two months, history of underlying diseases hypersensitivity to hydroxychloroquine and G6PD enzyme deficiency.
INTERVENTION AND COMPARATOR
Intervention group: Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical.
CONTROL GROUP
placebo which is completely similar in form and taste to 200 mg hydroxychloroquine tablet and is manufactured by the same factory (Amin Pharmacy). The dosage is two tablets daily, once a week for one to three months (based on the duration of the Coronavirus epidemic in Tehran).
MAIN OUTCOMES
Confirmed COVID-19 virus infection using Polymerase chain reaction (PCR) test is the primary outcome. The time period for measuring the primary outcome is any infection within the trial period up to one month after taking the last dose.
RANDOMISATION
The randomized block allocation method was developed using Stata version 15 software by an independent researcher, using a block size of six. Allocation to the two treatment groups will be conducted by this researcher using paper labels (random 10-digit codes) in a 1:1 ratio t The labels will be attached to the drug packages in order of randomization. Drug packages will be arranged in a box according to the randomization list.
BLINDING (MASKING)
Participants and caregivers are blinded to group assignment and the data will be analyzed by an independent statistical expert who is unaware of the treatment allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
A total of 282 participants will be randomised with 141 participants the Hydroxychloroquineeach intervention group and 141 participants to the placebo control group TRIAL STATUS: The protocol version number is 99-1-101-47091 and the approval ID is IR.TUMS.VCR.REC.1399.001 and recruitment began April 7, 2020, and is anticipated to be complete by August 7, 2020.
TRIAL REGISTRATION
The name of the trial register is Iranian registry of clinical trial (IRCT), registration number is IRCT20120826010664N6, date of trial registration is April 7, 2020, FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Single centre, 2-arm, double-blind randomised (ratio 1:1)","['282 participants will be randomised with 141 participants the Hydroxychloroquineeach intervention group and 141 participants to the', 'healthcare professionals', ' Treatment staff who are in contact with patients and have at least 3 shifts a week in Arash hospital affiliated with Tehran University of Medical Sciences, in Iran and who consent to participate in the study']","['GROUP\n\n\nplacebo', 'hydroxychloroquine', 'hydroxychloroquine with placebo', 'placebo control', 'Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical', 'placebo']",['COVID-19 virus infection using Polymerase chain reaction (PCR) test'],"[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",282.0,0.426417,"Single centre, 2-arm, double-blind randomised (ratio 1:1)","[{'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Pirjani', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran. pirjani@razi.tums.ac.ir.""}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Soori', 'Affiliation': 'Department of Infectious Diseases, Arash Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Dehpour', 'Affiliation': 'Department of Pharmacology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Arshia', 'Initials': 'A', 'LastName': 'Shizarpour', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Razieh Mohammad', 'Initials': 'RM', 'LastName': 'Jafari', 'Affiliation': 'Experimental Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04439-3']
2609,32493383,MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial.,"INTRODUCTION
In the work-up strategy for pulmonary embolism (PE) in the ED, the recently introduced YEARS rule allows the raising of the D-dimer threshold to 1000 ng/ml in patients with no signs of deep venous thrombosis and no hemoptysis and in whom PE is not the most likely diagnosis. However, this decision rule has never been prospectively compared to the usual strategy. Furthermore, it is unclear if the YEARS rule can be used on top of the Pulmonary Embolism Rule-out Criteria (PERC). We aim to assess the non-inferiority of YEARS compared to current guidelines to rule out PE among PERC-positive ED patients with suspicion of PE.
METHODS/DESIGN
The MODIGLIANI study is a multicenter, European, non-inferiority, cluster-randomized, two periods cross-over, controlled trial. Each center will be randomized for the sequence of two 4-month periods: intervention (MOdified Diagnostic Strategy: MODS) followed by control (usual care), or control followed by intervention with 1 month of ""wash-out"" between the two periods. In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients). In the MODS period, the threshold of D-dimers to rule out PE will be raised to 1000 ng/ml if no item of the YEARS score is present or will remain unchanged otherwise. Patients will be included if they have a suspicion of PE, defined as chest pain, dyspnea, or syncope. Non-inclusion criteria comprise a high clinical probability of PE or PERC-negative patients with low clinical probability.
ETHICS AND DISSEMINATION
The study has received the following approvals: Comité de protection des personnes Ile de France XI (France) and Comité de Ética de la Investigación con medicamentos del Hospital Clínic de Barcelona (Spain). Results will be made available to all included participants and other researchers.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04032769. Registered on 24 July 2019.",2020,"In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients).","['Patients will be included if they have a suspicion of PE, defined as chest pain, dyspnea, or syncope. Non-inclusion criteria comprise a high clinical probability of PE or PERC-negative patients with low clinical probability', 'PERC-positive ED patients with suspicion of PE', 'patients aged 50 years or younger and age ×\u200910 for older patients']","['YEARS', 'intervention (MOdified Diagnostic Strategy: MODS) followed by control (usual care), or control followed by intervention with 1\u2009month of ""wash-out"" between the two periods']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]",[],,0.159928,"In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients).","[{'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Philippon', 'Affiliation': 'Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Dumont', 'Affiliation': 'Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jimenez', 'Affiliation': 'Emergency Department, Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Salhi', 'Affiliation': 'Department of clinical pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP.Sorbonne Universite, hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Cachanado', 'Affiliation': 'Department of clinical pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP.Sorbonne Universite, hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'Sorbonne Université, Paris, France.'}, {'ForeName': 'Tabassome', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Department of clinical pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP.Sorbonne Universite, hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Yonathan', 'Initials': 'Y', 'LastName': 'Freund', 'Affiliation': 'Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France. yonathanfreund@gmail.com.'}]",Trials,['10.1186/s13063-020-04379-y']
2610,32493462,"Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial.","BACKGROUND
Transcranial direct current stimulation (tDCS) is promising for improving motor and cognitive performance. Nevertheless, its mechanisms of action are unclear and need to be better characterised according to the stimulated brain area and the type of exercise performed.
METHODS/DESIGN
This is a double-blind crossover study, organised into two parts: the first is to assess the effects of tDCS on explosive performance (jump task) and the second is to assess the effects on endurance performance (cycling time trial task). Participants, who are recreationally active or athletes (parkour practitioners, cyclists), will receive two active tDCS sessions (over the left dorsolateral prefrontal cortex and right motor cortex) and one sham tDCS session (part A), or two sequences (one active and one sham) of two daily tDCS sessions over 5 days (part B). Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B).
DISCUSSION
This study investigates the acute and repeated effects of tDCS on the motor and cognitive performance of healthy subjects. It will try to evaluate if tDCS could be considered as a neuroenhancement technology according to the physical task investigated (endurance versus explosive).
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03937115. Registered on 3 May 2019; retrospectively registered.",2020,"Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B).
","['Participants, who are recreationally active or athletes (parkour practitioners, cyclists', 'healthy subjects', 'sports performance for two profiles of athletes (power and endurance']","['Transcranial direct current stimulation (tDCS', 'active tDCS sessions (over the left dorsolateral prefrontal cortex and right motor cortex) and one sham tDCS session (part A), or two sequences (one active and one sham) of two daily tDCS sessions', 'tDCS', 'transcranial direct current stimulation']",['Motor and cognitive performance'],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],,0.0921396,"Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B).
","[{'ForeName': 'Yohan', 'Initials': 'Y', 'LastName': 'Grandperrin', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France. ygrandperrin@chu-besancon.fr.""}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Grosprêtre', 'Affiliation': 'Laboratoire Culture, Sport, Santé, Société EA 4660, Université de Bourgogne Franche -Comté, UPFR Sports, 25000, Besançon, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Nicolier', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gimenez', 'Affiliation': 'Laboratoire Culture, Sport, Santé, Société EA 4660, Université de Bourgogne Franche -Comté, UPFR Sports, 25000, Besançon, France.'}, {'ForeName': 'Chrystelle', 'Initials': 'C', 'LastName': 'Vidal', 'Affiliation': ""Centre d'Investigation Clinique, INSERM CIC 1431, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Haffen', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}, {'ForeName': 'Djamila', 'Initials': 'D', 'LastName': 'Bennabi', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}]",Trials,['10.1186/s13063-020-04412-0']
2611,32493442,"Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial.","BACKGROUND
Almost 15% of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch-anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 10% of cases, inflammation of the pouch becomes chronic with very few treatments available. Previous studies have suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotics achieved significant results for treating acute episodes of UC-associated pouchitis. However, there is currently no established effective treatment for chronic antibiotic-dependent pouchitis. Fecal microbiota transplantation (FMT) is a novel therapy involving the transfer of normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by the disrupted homeostasis of intestinal microbiota or dysbiosis.
METHODS
Our project aims to compare the delay of relapse of chronic recurrent pouchitis after FMT versus sham transplantation. Forty-two patients with active recurrent pouchitis after having undergone an IPAA for UC will be enrolled at 12 French centers. The patients who respond to antibiotherapy will be randomized at a ratio of 1:1 to receive either FMT or sham transplantation.
DISCUSSION
On April 30, 2014, the World Health Organization published an alarming report on antibiotic resistance. Finding an alternative medical treatment to antibiotics in order to prevent relapses of pouchitis is therefore becoming increasingly important given the risk posed by multiresistant bacteria. Moreover, if the results of this study are conclusive, FMT, which is less expensive than biologics, could become a routine treatment in the future.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03524352. Registered on 14 May 2018.",2020,"Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability.","['chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis', 'patients with ulcerative colitis (UC', 'Forty-two patients with active recurrent pouchitis after having undergone an IPAA for UC will be enrolled at 12 French centers']","['FMT versus sham transplantation', 'Fecal microbiota transplantation (FMT', 'fecal microbiota transplantation', 'proctocolectomy with ileal pouch-anal anastomosis (IPAA', 'FMT or sham transplantation']",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0376620', 'cui_str': 'Pouchitis'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0192755', 'cui_str': 'Ileoanal anastomosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4505465', 'cui_str': 'Ileal Pouch Anal Anastomosis'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0400076', 'cui_str': 'Excision of colon and rectum'}, {'cui': 'C4505465', 'cui_str': 'Ileal Pouch Anal Anastomosis'}]",[],42.0,0.0899589,"Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Trang-Poisson', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Kerdreux', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Poinas', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France. alexandra.poinas@chu-nantes.fr.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Planche', 'Affiliation': 'Methodology and Biostatistics Unit, Delegation to Clinical Research and Innovation for CHU Nantes and Vendée departmental Hospital, Nantes, La Roche sur Yon, France.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Sokol', 'Affiliation': 'Sorbonne Université, Inserm, Centre de Recherche Saint-Antoine, CRSA, AP-HP, Hôpital Saint Antoine, Gastroenterology & Nutrition Department, F-75012, Paris, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Bemer', 'Affiliation': 'MiHAR lab, Nantes University, 44000, Nantes, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Cabanas', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Hivernaud', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Biron', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Flet', 'Affiliation': 'Pharmacy Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Montassier', 'Affiliation': 'MiHAR lab, Nantes University, 44000, Nantes, France.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Le Garcasson', 'Affiliation': 'MiHAR lab, Nantes University, 44000, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chiffoleau', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jobert', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Lepelletier', 'Affiliation': 'Bacteriology and Infection Control Department, CHU Nantes, 44000, Nantes, France.'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Caillon', 'Affiliation': 'Bacteriology and Infection Control Department, CHU Nantes, 44000, Nantes, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Le Pape', 'Affiliation': 'Parasitology-Mycology Department, Institute of Biology CHU Nantes, Nantes, France.'}, {'ForeName': 'Berthe-Marie', 'Initials': 'BM', 'LastName': 'Imbert', 'Affiliation': 'Virology Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourreille', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}]",Trials,['10.1186/s13063-020-04330-1']
2612,32493459,Umbilical cord blood therapy to prevent progression of COVID-19 related pneumonia: a structured summary of a study protocol for a pilot randomised controlled trial.,"OBJECTIVES
Objective: To undertake a pilot, feasibility RCT of umbilical cord blood derived cell therapy for treatment of adult patients infected with SARS-CoV-2 virus related moderate-to-severe pneumonia to prevent progression to severe ARDS.
HYPOTHESIS
Expanded cord blood derived cell therapy will be feasible, well tolerated and show potential efficacy in the treatment of acute COVID-19 related moderate to severe pneumonia in adult patients because of their powerful anti-inflammatory and immunomodulatory properties.
TRIAL DESIGN
Pilot, parallel design randomised controlled trial.
PARTICIPANTS
The trial will recruit 24 hospitalised patients with confirmed SARS-CoV-2 infection and pneumonia from July to December 2020 at Monash Medical Centre in Melbourne, Australia.
INTERVENTION AND COMPARATOR
Intervention: Intravenous injection of expanded umbilical cord blood cells at a dose of 5 million cells/kg (maximum dose - 500 million cells). Cell infusion will occur over 30-60 minutes through a peripheral intravenous cannula. Standard supportive care will continue as needed. Comparator: Standard supportive care.
MAIN OUTCOMES
Safety and tolerability of cell administration within first 24 hours of administration; clinical improvement on a seven-category clinical improvement ordinal scale.
RANDOMISATION
Randomisation will be done using computer generated allocation to intervention/ control groups in a 1:1 ratio (in blocks of 6) using sealed opaque envelopes.
BLINDING (MASKING)
This will be an unblinded study, given that it is the first study using expanded cord blood cells in COVID-19 patients. There will be no placebo infusion.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Twelve participants in each group. Total n=24.
TRIAL STATUS
CBC-19 protocol v2, dated 23 rd April 2020. Recruitment has not started yet. Estimated recruitment timeline is between 1st July - 31st December 2020.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry, ACTRN12620000478910, registered 16th April 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"HYPOTHESIS
Expanded cord blood derived cell therapy will be feasible, well tolerated and show potential efficacy in the treatment of acute COVID-19 related moderate to severe pneumonia in adult patients because of their powerful anti-inflammatory and immunomodulatory properties.
","['Total n=24', 'COVID-19 patients', 'adult patients infected with SARS-CoV-2 virus related moderate-to-severe pneumonia to prevent progression to severe ARDS', '24 hospitalised patients with confirmed SARS-CoV-2 infection and pneumonia from July to December 2020 at Monash Medical Centre in Melbourne, Australia', 'CBC-19 protocol v2, dated 23 rd April 2020']","['umbilical cord blood derived cell therapy', 'Umbilical cord blood therapy', 'Comparator', 'Intravenous injection of expanded umbilical cord blood cells']",['Safety and tolerability of cell administration within first 24 hours of administration; clinical improvement on a seven-category clinical improvement ordinal scale'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",24.0,0.481327,"HYPOTHESIS
Expanded cord blood derived cell therapy will be feasible, well tolerated and show potential efficacy in the treatment of acute COVID-19 related moderate to severe pneumonia in adult patients because of their powerful anti-inflammatory and immunomodulatory properties.
","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': ""Monash Children's Hospital, Melbourne, Australia. atul.malhotra@monash.edu.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ernest', 'Affiliation': 'Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Australia.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Rogers', 'Affiliation': 'Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Haylock', 'Affiliation': 'Kabeth Consulting, Melbourne, Australia.'}, {'ForeName': 'Ashalyn', 'Initials': 'A', 'LastName': 'Watt', 'Affiliation': 'Hudson Institute of Medical Research, Melbourne, Australia.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Moeneclaey', 'Affiliation': 'Hudson Institute of Medical Research, Melbourne, Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Jenkin', 'Affiliation': 'Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Australia.'}]",Trials,['10.1186/s13063-020-04387-y']
2613,31409509,Intermittent energy restriction is comparable to continuous energy restriction for cardiometabolic health in adults with central obesity: A randomized controlled trial; the Met-IER study.,"BACKGROUND & AIMS
Short bouts of severe energy restriction may have additional, beneficial cardiometabolic effects beyond that of weight loss. We aimed to assess the short-term effects of intermittent fasting on insulin sensitivity and related cardiometabolic mechanisms.
METHODS
This parallel arm, randomized controlled trial compared the short-term effects of intermittent and continuous energy restriction (IER and CER) diets on markers of cardiometabolic health in individuals with central obesity, aiming for equivalent weight loss on both diets. Outcomes were assessed in non-smoking men and women (35-75 y), following 4-wk IER (48 h 600 kcal/d followed by 5-day healthy eating advice) or CER diets (-500 kcal/d healthy eating advice). The primary outcome was the revised quantitative insulin sensitivity check index (R-QUICKI), an indirect estimate of insulin sensitivity. Secondary outcomes included ambulatory blood pressure (ABP), indicators of sympathetic activity (heart rate variability (HRV) and normetanephrine), and markers of glucose homeostasis/insulin resistance, adiposity, lipids and inflammation.
RESULTS
Forty-three participants completed the study. Reductions in body weight were equivalent in both groups: mean loss (%) -2.6; 95% CI -3.3, -1.9 and -2.9; -3.6, -2.1 for CER and IER, respectively, P = 0.464). R-QUICKI increased following IER and CER, with no between-diet differences (overall mean increase (%) 6.6; 3.6, 9.6). Fasting plasma glucose concentrations decreased after CER but not after IER (mean difference CER-IER - 4.8% (0.7, 8.9), P < 0.05) and fasting plasma non-esterified fatty acid concentrations were lower after IER compared to CER (mean difference CER-IER 0.15 mmol/L (0.06, 0.24), P < 0.005). There were no differences in lipids, adipokine/inflammatory markers, ABP or HRV between diets.
CONCLUSIONS
Short-term CER or IER diets are comparable in their effects on most markers of cardiometabolic risk, although adaptive changes in glucose and fatty acid metabolism occur. This study is registered at clinicaltrials.gov as NCT02679989.",2020,"Reductions in body weight were equivalent in both groups: mean loss (%) -2.6; 95% CI -3.3, -1.9 and -2.9; -3.6, -2.1 for CER and IER, respectively, P = 0.464).","['individuals with central obesity', 'Forty-three participants completed the study', 'adults with central obesity']","['intermittent and continuous energy restriction (IER and CER) diets', 'CER diets']","['ambulatory blood pressure (ABP), indicators of sympathetic activity (heart rate variability (HRV) and normetanephrine), and markers of glucose homeostasis/insulin resistance, adiposity, lipids and inflammation', 'Fasting plasma glucose concentrations', 'lipids, adipokine/inflammatory markers, ABP or HRV', 'revised quantitative insulin sensitivity check index (R-QUICKI), an indirect estimate of insulin sensitivity', 'fasting plasma non-esterified fatty acid concentrations', 'body weight']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0237504', 'cui_str': 'CER (body structure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0028385', 'cui_str': '3-Methoxynoradrenaline'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",43.0,0.234997,"Reductions in body weight were equivalent in both groups: mean loss (%) -2.6; 95% CI -3.3, -1.9 and -2.9; -3.6, -2.1 for CER and IER, respectively, P = 0.464).","[{'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Pinto', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK. Electronic address: ana_margarida.pinto@kcl.ac.uk.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bordoli', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Buckner', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Curie', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Polly C', 'Initials': 'PC', 'LastName': 'Kaplan', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Ines M', 'Initials': 'IM', 'LastName': 'Del Arenal', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Jeffcock', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.07.014']
2614,32493401,Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan.,"BACKGROUND
The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease. An investigator-initiated, double-blind, randomised, placebo-controlled, multicentre phase 2 clinical trial started recruitment in December 2017, with the aim of evaluating the efficacy and safety of GKT13783, in adults with type 1 diabetes mellitus and persistently elevated urinary albumin excretion over a period of 48 weeks.
METHODS/DESIGN
The trial is currently recruiting in Australia and New Zealand, with recruitment expected to end on 30 June 2020. The primary outcome measure of the trial is the urinary albumin excretion level measured at 48 weeks of treatment. This statistical analysis plan presents an update to the published trial protocol and provides a comprehensive description of the statistical methods that will be used for the analysis of the data from this trial. In doing so, we follow the ""Guidelines for the content of statistical analysis plans in clinical trials"" to support transparency and reproducibility of the trial findings.
DISCUSSION
With the use of this prior statistical analysis plan, we aim to minimise bias in the reporting of the findings of this trial, which evaluates the investigational medicinal product GKT137831. The results of the trial are expected to be published in 2022.
TRIAL REGISTRATION
ANZCTR registry: ACTRN12617001187336. Registered on 14 July 2017. Universal Trial Number: U1111-1187-2609; Protocol number: T1DGKT137831; Genkyotex trial number: GSN000241.",2020,"BACKGROUND
The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease.","['adults with type 1 diabetes and persistently elevated urinary albumin excretion', 'adults with type 1 diabetes mellitus and persistently elevated urinary albumin excretion over a period of 48\u2009weeks']","['GKT13783', 'placebo']","['efficacy and safety', 'urinary albumin excretion level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.413203,"BACKGROUND
The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease.","[{'ForeName': 'Alysha M', 'Initials': 'AM', 'LastName': 'De Livera', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia. alyshad@unimelb.edu.au.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Reutens', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Monash University, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'Merlin', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Monash University, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Jandeleit-Dahm', 'Affiliation': 'Monash University, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Agus', 'Initials': 'A', 'LastName': 'Salim', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia.'}]",Trials,['10.1186/s13063-020-04404-0']
2615,32493434,Community-based program to increase use of hearing conservation practices among farm and rural youth: a cluster randomized trial of effectiveness.,"BACKGROUND
Noise exposure and associated hearing loss affects an estimated 2 million farm youth who are exposed as farm residents, farm family workers, hired workers, children of migrant or seasonal workers, and farm visitors. Risk factors for farm youth include frequent exposure to high farm noise; farm work from an early age, and exposure to high recreational noise (e.g., firearms, ATVs, and personal listening devices).
METHODS
This study compared the effectiveness of two interventions and control. The programs included a community-based interactive youth educational program alone (Group A), a community-based interactive youth educational program followed by an Internet-based booster (Group B), and a no-interaction control (Group C). The study used a cluster randomized control design, with equal allocation ratio to each cluster, without blinding. Inclusion criteria included enrollment in grade 4, parental consent, English speaking, and attending a community-based educational event included in the cluster sampling. A total of 1979 youth were enrolled at 36 sites distributed across the 3 study arms in the following distribution: N = 662 in 13 sites (Group A), N = 680 in 12 sites (Group B), and N = 637 in 11 sites (Group C).
RESULTS
Comparison with pre-intervention data showed no difference in intent to use hearing conservation strategies in experimental groups. However, knowledge and attitudes toward hearing conservation were improved in the groups receiving the Internet-based booster. Participants reported frequent exposure to sources of hazardous noise (e.g., loud sporting events, firecrackers, personal listening devices).
CONCLUSIONS
It is feasible and acceptable to incorporate hearing health education into an already existing system designed to deliver health and safety educational programming to farm and rural youth. The program was adopted by the partner agency for dissemination to up to 100,000 youth annually. Results of this study inform future intervention studies, interventions aimed at farm youth, and interventions to increase use of hearing conservation strategies, as well as offer a base for developing programs for non-English speaking children.
TRIAL REGISTRATION
Clinicaltrials.gov registration CT02472821. Date of trial registration: 06/09/2015 (retrospectively registered).",2020,It is feasible and acceptable to incorporate hearing health education into an already existing system designed to deliver health and safety educational programming to farm and rural youth.,"['hearing conservation practices among farm and rural youth', 'A total of 1979 youth were enrolled at 36 sites distributed across the 3 study arms in the following distribution: N\xa0=\u2009662 in 13 sites (Group A), N\xa0=\u2009680 in 12 sites (Group B), and N\xa0', '2 million farm youth who are exposed as farm residents, farm family workers, hired workers, children of migrant or seasonal workers, and farm visitors', 'Inclusion criteria included enrollment in grade 4, parental consent, English speaking, and attending a community-based educational event included in the cluster sampling']","['Community-based program', 'community-based interactive youth educational program alone (Group A), a community-based interactive youth educational program followed by an Internet-based booster (Group B), and a no-interaction control']","['knowledge and attitudes toward hearing conservation', 'frequent exposure to sources of hazardous noise (e.g., loud sporting events, firecrackers, personal listening devices']","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0600634', 'cui_str': 'Parental Consent'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0336696', 'cui_str': 'Firecracker'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.0391096,It is feasible and acceptable to incorporate hearing health education into an already existing system designed to deliver health and safety educational programming to farm and rural youth.,"[{'ForeName': 'Marjorie C', 'Initials': 'MC', 'LastName': 'McCullagh', 'Affiliation': 'School of Nursing, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109-5482, USA. mcculla@umich.edu.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109-5482, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cohen', 'Affiliation': 'School of Nursing, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109-5482, USA.'}]",BMC public health,['10.1186/s12889-020-08972-3']
2616,32224318,Perspectives on the model-based approach to proton therapy trials: A retrospective study of a lung cancer randomized trial.,"PURPOSE
The goal of this study was to assess whether a model-based approach applied retrospectively to a completed randomized controlled trial (RCT) would have significantly altered the selection of patients of the original trial, using the same selection criteria and endpoint for testing the potential clinical benefit of protons compared to photons.
METHODS AND MATERIALS
A model-based approach, based on three widely used normal tissue complication probability (NTCP) models for radiation pneumonitis (RP), was applied retrospectively to a completed non-small cell lung cancer RCT (NCT00915005). It was assumed that patients were selected by the model-based approach if their expected ΔNTCP value was above a threshold of 5%. The endpoint chosen matched that of the original trial, the first occurrence of severe (grade ≥3) RP.
RESULTS
Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for lung cancer using RP as the normal tissue endpoint. The analyzed lung trial showed that less than 19% (32/165) of patients enrolled in the completed trial would have been enrolled in a model-based trial, prescribing photon therapy to all other patients. The number of patients enrolled was also found to be dependent on the type of NTCP model used for evaluating RP, with the three models enrolling 3%, 13% or 19% of patients. This result does show limitations in NTCP models which would affect the success of a model-based trial approach. No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made.
CONCLUSIONS
Uncertainties in the outcome models to predict NTCP are the inherent drawback of a model-based approach to clinical trials. The impact of these uncertainties on enrollment in model-based trials depends on the predicted difference between the two treatment arms and on the set threshold for patient stratification. Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for specific treatment sites, such as lung cancer, depending on the chosen normal tissue endpoint.",2020,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made.
",[],[],[],[],[],[],,0.0324994,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made.
","[{'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McNamara', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA. Electronic address: amcnamara2@mgh.harvard.edu.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Shusharina', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ajdari', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Paganetti', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.02.022']
2617,21804804,"A comparative evaluation of intrathecal bupivacaine alone, sufentanil or butorphanol in combination with bupivacaine for endoscopic urological surgery.","BACKGROUND
The objective of the present study was to compare the onset, degree and recovery time of sensory and motor block and hemodynamic effects of intrathecal bupivacaine alone and bupivacaine with sufentanil or butorphanol in endoscopic urological surgeries.
METHODS
In a randomized, double-blind study, 90 patients of either sex and age, belonging to ASA Grades I and II, scheduled for elective endoscopic urological surgeries under spinal anesthesia, were allocated into three groups of 30 each. Patients received either 2.5 ml of 0.5% hyperbaric buypivacaine 12.5 mg (Group A), 1.5 ml of 0.5% hyperbaric bupivacaine 7.5 mg with 10 μg sufentanil (Group B) or 1.5 ml of 0.5% hyperbaric bupivacaine 7.5 mg with 25 μg butorphanol (Group C). Vital parameters, level, duration and regression of sensory block and motor block and side-effects were recorded and compared.
STATISTICAL ANALYSIS
Analysis of variance (ANOVA), post hoc test and Chi-square test were used.
RESULTS
Intrathecal addition of sufentanil/butorphanol prolonged the duration of sensory block (DOSB) compared with bupivacaine alone (DOSB being 156.83±23.83 min, 170.87 ± 22.21 min and 171.17 ± 23.99 min in groups A, B and C, respectively) without altering the duration of motor blockade. Bromage score 3 was achieved in 100%, 90% and 54.4% patients in groups A, B and C, respectively. The time to first request for analgesia was 112 ± 46.3 min, 323 ± 65.0 min and 299 ± 73.9 min in groups A, B and C, respectively. Complications were reduced by the addition of butorphanol, which also has a lower tendency than sufentanil to produce pruritus (60%).
CONCLUSIONS
The analgesia was significantly prolonged in groups B and C; group C had a less-intense motor block. Complications were reduced by the addition of butorphanol, which also has a lower tendency than sufentanil to produce pruritus. Thus, this combination of butorphanol with low-dose bupivacaine is especially beneficial in the geriatric group of patients who have multiple co-morbid conditions.",2011,"Bromage score 3 was achieved in 100%, 90% and 54.4% patients in groups A, B and C, respectively.","['90 patients of either sex and age, belonging to ASA Grades', 'geriatric group of patients who have multiple co-morbid conditions', 'I and II, scheduled for elective endoscopic urological surgeries under spinal anesthesia', 'endoscopic urological surgery']","['bupivacaine with sufentanil or butorphanol', 'bupivacaine', 'sufentanil/butorphanol', 'butorphanol', 'intrathecal bupivacaine', 'hyperbaric bupivacaine 7.5 mg with 10 μg sufentanil (Group B) or 1.5 ml of 0.5% hyperbaric bupivacaine 7.5 mg with 25 μg butorphanol', 'sufentanil', '2.5 ml of 0.5% hyperbaric buypivacaine', 'sufentanil or butorphanol']","['duration of motor blockade', 'time to first request for analgesia', 'Vital parameters, level, duration and regression of sensory block and motor block and side-effects', 'Complications', 'duration of sensory block (DOSB', 'analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1275743', 'cui_str': 'Comorbid conditions'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.236256,"Bromage score 3 was achieved in 100%, 90% and 54.4% patients in groups A, B and C, respectively.","[{'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesia and Critical Care, J.P.N.A Trauma Centre, AIIMS, New Delhi, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Katyal', 'Affiliation': ''}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Kathuria', 'Affiliation': ''}, {'ForeName': 'Prabhjot', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82804']
2618,32211987,Medical practice and placebo response: an inseparable bond?,"The history of medicine and the history of placebo are closely intertwined. To understand placebo and its effects this article gives a brief overview about its history, the possible mechanisms of action and its counterpart, nocebo.The Catholic Church used placebo around the sixteenth century for the separation from real and incorrect exorcisms, but it needed Henry Beecher during World War II to quantify the placebo effect as control arm in well-designed studies.Until today the different mechanisms of action of placebo remain poorly researched. Understanding them would allow its effect to be modulated to better serve in research and clinical settings. Expectation, psychosocial context and conditioning play a significant role in the effect size and amplitude.The counterpart, nocebo, is even less investigated, even it is commonly observed as adverse effects during medical treatments.Conclusion: Placebo and nocebo are both underestimated and underresearched in their value. Through further investigation doctors could strengthen the placebo response and prevent adverse effects to help their patients at low cost. These techniques would benefit the patient-doctor relationship, which is the alter of a trust-based successful therapy.",2020,"Expectation, psychosocial context and conditioning play a significant role in the effect size and amplitude.",[],"['Placebo', 'placebo']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.177075,"Expectation, psychosocial context and conditioning play a significant role in the effect size and amplitude.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jilch', 'Affiliation': 'Medical University of Vienna, Vienna, Austria. n1104225@students.meduniwien.ac.at.'}, {'ForeName': 'Ruken', 'Initials': 'R', 'LastName': 'Sel', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Shahrokh F', 'Initials': 'SF', 'LastName': 'Shariat', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}]",Wiener klinische Wochenschrift,['10.1007/s00508-020-01626-9']
2619,31410475,"Exploring the Specificity, Synergy, and Durability of Auditory and Visual Computer Gameplay Transfer Effects in Healthy Older Adults.","OBJECTIVES
To determine whether auditory and visual computer games yield transfer effects that (a) are modality-specific to verbal memory (auditory stimulus presentation) and visual-processing tests, (b) affect working memory and processing speed, (c) are synergistic for combined game-type play, and (d) are durable.
METHOD
A Pilot Study (N = 44) assessed visual transfer effects in a two-group pre-post design. The Main Study (N = 151) employed a 2 (visual games: yes, no) × 2 (auditory games: yes, no) × 3 (test session: pretest, post-test, follow-up) design, allowing different training groups to act as active controls for each other. Neuropsychological test scores were aggregated into verbal-memory (auditory presentation), visual-processing, working-memory, and processing-speed indexes.
RESULTS
Visual-processing and working-memory pre-post-training change scores were differentially modulated across the four gameplay groups in the main sample, demonstrating transfer effects differing across both active- and passive-control groups. Visual training yielded modality-specific transfer effects in both samples, transfer to working memory in the main sample, and transfer to processing speed in the pilot sample. There were no comparable transfer effects for auditory training. Combined-visual-and-auditory training failed to yield synergistic effects or any significant transfer effects. Visual-processing transfer effects remained significant at follow-up.
DISCUSSION
Visual and auditory games differentially modulated transfer effects. Domain-specific visual transfer effects were found at post-test and were durable at follow-up. Visual gameplay holds potential to ameliorate age-related cognitive decline in visual cognition.",2020,"RESULTS
Visual-processing and working-memory pre-post-training change scores were differentially modulated across the four gameplay groups in the main sample, demonstrating transfer effects differing across both active- and passive-control groups.",['Healthy Older Adults'],"['2 (visual games: yes, no) x 2 (auditory games: yes, no', 'Combined-visual-and-auditory training']","['verbal-memory (auditory presentation), visual-processing, working-memory, and processing-speed indexes', 'Visual-processing and working-memory pre-post-training change scores', 'Neuropsychological test scores', 'visual transfer effects', 'Visual-processing transfer effects', 'Domain-specific visual transfer effects']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0589087', 'cui_str': 'Visual processing, function (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.0355473,"RESULTS
Visual-processing and working-memory pre-post-training change scores were differentially modulated across the four gameplay groups in the main sample, demonstrating transfer effects differing across both active- and passive-control groups.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Faust', 'Affiliation': 'Department of Psychological Science, University of North Carolina at Charlotte, North Carolina.'}, {'ForeName': 'Kristi S', 'Initials': 'KS', 'LastName': 'Multhaup', 'Affiliation': 'Department of Psychology, Davidson College, North Carolina.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Ong', 'Affiliation': 'Iredell Memorial Hospital, Statesville, North Carolina.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Demakis', 'Affiliation': 'Department of Psychological Science, University of North Carolina at Charlotte, North Carolina.'}, {'ForeName': 'Kelly G', 'Initials': 'KG', 'LastName': 'Balz', 'Affiliation': 'Department of Psychology, Davidson College, North Carolina.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz096']
2620,31165577,Comparing the Effects of Single- and Multiple-Component Therapies for Insomnia on Sleep Outcomes.,"BACKGROUND
Single- and multiple-component therapies are recommended in professional guidelines for managing chronic insomnia. Systematic reviews point to insufficient evidence of the comparative effectiveness of these therapies, which is required for treatment decision making.
PURPOSE
To compare the effectiveness of three single-component and one multiple-component therapies on short-term sleep outcomes.
METHODS
The data were obtained from 517 persons with chronic insomnia, enrolled in a partially randomized preference trial. They were allocated to the single-component therapies: sleep education and hygiene (SEH), stimulus control therapy (SCT), and sleep restriction therapy (SRT), or the multiple-component therapy (MCT). The outcomes, perceived insomnia severity and sleep parameters, were assessed with established measures at pre and posttest. Repeated measure analysis of variance was used to compare the outcomes across therapy groups over time. The clinical relevance of the therapies' effects was evaluated by examining the effect size and remission rate.
RESULTS
The four therapies differed in their effectiveness in reducing perceived insomnia severity and improving sleep outcomes. SEH was least effective. SCT, SRT, and MCT were moderately effective. SCT and SRT demonstrated slightly higher remission rates than MCT for perceived insomnia severity and some sleep parameters.
LINKING EVIDENCE TO ACTION
SCT and SRT are viable single-component therapies that produce clinical benefits. Single-component insomnia treatment may be more convenient to implement in the primary care setting due to the reduced number of treatment recommendations compared to MCT.",2019,"SCT and SRT demonstrated slightly higher remission rates than MCT for perceived insomnia severity and some sleep parameters.
",['517 persons with chronic insomnia'],"['MCT', 'SCT and SRT', 'Single- and Multiple-Component Therapies', 'single-component therapies: sleep education and hygiene (SEH), stimulus control therapy (SCT), and sleep restriction therapy (SRT), or the multiple-component therapy (MCT']","['effect size and remission rate', 'Sleep Outcomes', 'perceived insomnia severity and improving sleep outcomes', 'remission rates', 'perceived insomnia severity and sleep parameters']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}]","[{'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",517.0,0.031359,"SCT and SRT demonstrated slightly higher remission rates than MCT for perceived insomnia severity and some sleep parameters.
","[{'ForeName': 'Souraya', 'Initials': 'S', 'LastName': 'Sidani', 'Affiliation': 'Daphne Cockwell School of Nursing, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Dana R', 'Initials': 'DR', 'LastName': 'Epstein', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fox', 'Affiliation': 'School of Nursing, York University, Toronto, ON, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'Daphne Cockwell School of Nursing, Ryerson University, Toronto, ON, Canada.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12367']
2621,32493372,Comparison of intrathecal morphine with continuous patient-controlled epidural anesthesia versus intrathecal morphine alone for post-cesarean section analgesia: a randomized controlled trial.,"BACKGROUND
Several neuraxial techniques have demonstrated effective post-cesarean section analgesia. According to previous reports, it is likely that patient-controlled epidural analgesia (PCEA) without opioids is inferior to intrathecal morphine (IM) alone for post-cesarean section analgesia. However, little is known whether adding PCEA to IM is effective or not. The aim of this study was to compare post-cesarean section analgesia between IM with PCEA and IM alone.
METHODS
Fifty patients undergoing elective cesarean section were enrolled in this prospective randomized study. Patients were randomized to one of two groups: IM group and IM + PCEA group. All patients received spinal anesthesia with 12 mg of 0.5% hyperbaric bupivacaine, 10 μg of fentanyl, and 150 μg of morphine. Patients in IM + PCEA group received epidural catheterization through Th11-12 or Th12-L1 before spinal anesthesia and PCEA (basal 0.167% levobupivacaine infusion rate of 6 mL/h, bolus dose of 3 mL in lockout interval of 30 min) was commenced at the end of surgery. A numerical rating scale (NRS) at rest and on movement at 4,8,12,24,48 h after the intrathecal administration of morphine were recorded. In addition, we recorded the incidence of delayed ambulation and the number of patients who requested rescue analgesics. We examined NRS using Bonferroni's multiple comparison test following repeated measures analysis of variance; p < 0.05 was considered as statistically significant.
RESULTS
Twenty-three patients in each group were finally analyzed. Mean NRS at rest was significantly higher in IM group than in IM + PCEA group at 4 (2.7 vs 0.6), 8 (2.2 vs 0.6), and 12 h (2.5 vs 0.7), and NRS during mobilization was significantly higher in IM group than in IM + PCEA group at 4 (4.9 vs 1.5), 8 (4.8 vs 1.9), 12 (4.9 vs 2), and 24 h (5.7 vs 3.5). The number of patients who required rescue analgesics during the first 24 h was significantly higher in IM group compared to IM + PCEA group. No significant difference was observed between the groups in incidence of delayed ambulation.
CONCLUSIONS
The combined use of PCEA with IM provided better post-cesarean section analgesia compared to IM alone.
TRIAL REGISTRATION
UMIN-CTR (Registration No. UMIN000032475). Registered 6 May 2018 - Retrospectively registered.",2020,The number of patients who required rescue analgesics during the first 24 h was significantly higher in IM group compared to IM + PCEA group.,"['Fifty patients undergoing elective cesarean section', 'post-cesarean section analgesia']","['PCEA and IM alone', 'PCEA', 'IM group and IM\u2009+\u2009PCEA', 'morphine', 'intrathecal morphine alone', 'epidural catheterization through Th11-12 or Th12-L1 before spinal anesthesia and PCEA (basal 0.167% levobupivacaine', 'intrathecal morphine', 'IM\u2009+\u2009PCEA', 'spinal anesthesia with 12\u2009mg of 0.5% hyperbaric bupivacaine']","['numerical rating scale (NRS', 'Mean NRS at rest', 'incidence of delayed ambulation', 'NRS during mobilization', 'delayed ambulation and the number of patients who requested rescue analgesics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",50.0,0.0935582,The number of patients who required rescue analgesics during the first 24 h was significantly higher in IM group compared to IM + PCEA group.,"[{'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Sato', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan. iwasakih@asahikawa-med.ac.jp.'}, {'ForeName': 'Sarah Kyuragi', 'Initials': 'SK', 'LastName': 'Luthe', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Iida', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kanda', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}]",BMC anesthesiology,['10.1186/s12871-020-01050-6']
2622,32493387,Multi-ingredient pre-workout supplementation changes energy system contribution and improves performance during high-intensity intermittent exercise in physically active individuals: a double-blind and placebo controlled study.,"BACKGROUND
Nutritional ergogenic aids are commonly used to boost physiological adaptations to exercise and promote greater fitness gains. However, there is a paucity of data about multi-ingredient pre-workout supplementation (MIPS). Therefore, the aim of the present study was to investigate the acute effects of MIPS on the oxidative, glycolytic and ATP-CP energy systems contribution, time spent above 90% V̇O 2max (T90% V̇O 2max ), excess post-exercise oxygen consumption (EPOC) magnitude, number of efforts and time to exhaustion during a high-intensity interval exercise (HIIE) session.
METHODS
Twelve physically-active and healthy men completed the HIIE sessions that involved running bouts of 15 s on the treadmill at 120% of the maximum aerobic speed (MAS), interspersed with 15 s of passive recovery. Blood lactate was collected at immediately post, 3, 5, and 7 min post exercise. The contribution of ATP-CP, glycolytic and oxidative systems was analyzed at rest, during the HIIE sessions and for 20 min post. Performance variables (time to exhaustion, number of efforts) and oxygen consumption were also analyzed.
RESULTS
MIPS significantly increased the number of efforts performed (MIPS: 41 ± 10 vs Placebo: 36 ± 12, p = 0.0220) and time to exhaustion (MIPS: 20.1 ± 6 min vs Placebo: 17 ± 5 min, p = 0.0226). There was no difference between supplements for both T90% V̇O 2max (p = 0.9705) and EPOC (p = 0.4930). Consuming MIPS significantly increased the absolute oxidative energy system contribution by 23.8% (p = 0.0163) and the absolute ATP-CP contribution by 28.4% (p = 0.0055) compared to placebo. There was only a non-significant tendency for a higher glycolytic system contribution after MIPS ingestion (p = 0.0683).
CONCLUSION
Acute MIPS ingestion appears effective at increasing both aerobic and anaerobic alactic energy contribution and time to exhaustion during a HIIE protocol.",2020,Consuming MIPS significantly increased the absolute oxidative energy system contribution by 23.8% (p = 0.0163) and the absolute ATP-CP contribution by 28.4% (p = 0.0055) compared to placebo.,"['physically active individuals', 'Twelve physically-active and healthy men']","['MIPS', 'Placebo', 'HIIE sessions that involved running bouts of 15\u2009s on the treadmill at 120% of the maximum aerobic speed (MAS), interspersed with 15\u2009s of passive recovery', 'placebo']","['Blood lactate', 'absolute oxidative energy system contribution', 'oxidative, glycolytic and ATP-CP energy systems contribution, time spent above 90% V̇O 2max (T90% V̇O 2max ), excess post-exercise oxygen consumption (EPOC', 'Performance variables (time to exhaustion, number of efforts) and oxygen consumption', 'absolute ATP-CP contribution', 'magnitude, number of efforts and time to exhaustion']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0280558', 'cui_str': 'COPE regimen'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449286', 'cui_str': 'Degree'}]",12.0,0.210464,Consuming MIPS significantly increased the absolute oxidative energy system contribution by 23.8% (p = 0.0163) and the absolute ATP-CP contribution by 28.4% (p = 0.0055) compared to placebo.,"[{'ForeName': 'Caique', 'Initials': 'C', 'LastName': 'Figueiredo', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, School of Technology and Sciences, Presidente Prudente, São Paulo, Brazil; Post Graduation Program in Physical Therapy, São Paulo State University (UNESP), São Paulo, Brazil.'}, {'ForeName': 'Fábio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, School of Technology and Sciences, Presidente Prudente, São Paulo, Brazil; Post Graduation Program in Physical Therapy, São Paulo State University (UNESP), São Paulo, Brazil.'}, {'ForeName': 'Fabricio Eduardo', 'Initials': 'FE', 'LastName': 'Rossi', 'Affiliation': 'Immunometabolism of Skeletal Muscle and Exercise Research Group, Department of Physical Education and Associate Graduate Program in Health Science, Federal University of Piauí (UFPI), Teresina, PI, Brazil.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Billaut', 'Affiliation': 'Department of Kinesiology, Laval University, Laval, Quebec, QC, Canada.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Loschi', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, School of Technology and Sciences, Presidente Prudente, São Paulo, Brazil; Post Graduation Program in Physical Therapy, São Paulo State University (UNESP), São Paulo, Brazil.'}, {'ForeName': 'Camila S', 'Initials': 'CS', 'LastName': 'Padilha', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, School of Technology and Sciences, Presidente Prudente, São Paulo, Brazil; Post Graduation Program in Physical Therapy, São Paulo State University (UNESP), São Paulo, Brazil. camilapersonal@yahoo.com.br.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00357-6']
2623,32193166,Add a comment … how fitspiration and body positive captions attached to social media images influence the mood and body esteem of young female Instagram users.,"Social media content can negatively influence body esteem in young women by reinforcing beliefs that to be considered attractive, people must look a certain way. The current study examines how text associated with attractive social media images impacts on female users' mood and feelings about their own body. Female participants (N = 109) aged between 18 and 25 years were randomly allocated to one of three conditions in which they viewed the same fitspiration-style images from Instagram. However, the captions associated with each image were experimentally manipulated to reflect either a fitspiration, body positive, or neutral theme. Images associated with fitspiration captions encouraging observers to improve their personal fitness led to increased negative mood. When body-positive captions encouraging the self-acceptance of appearance or highlighting the unrealistic nature of social media content were viewed with the same images, no increase in negative affect was observed, and participants reported greater body esteem post exposure. The findings provide partial support for the idea that body positive comments accompanying images on Instagram may have some protective value for female body esteem. Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.",2020,"Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.","['Female participants (N = 109) aged between 18 and 25 years', 'young female Instagram users', ""female users' mood and feelings about their own body"", 'young women']",[],"['body esteem', 'mood and body esteem']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0026516', 'cui_str': 'Mood'}]",109.0,0.0163805,"Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.","[{'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Davies', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Bryony.Davies@port.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Mark.Turner@port.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Udell', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Julie.Udell@port.ac.uk.'}]",Body image,['10.1016/j.bodyim.2020.02.009']
2624,32493407,"A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol.","BACKGROUND
Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or 'delayed' orally administered antibiotics, could be at least as effective and safe as immediate orally administered antibiotics for children with AOMd.
METHODS/DESIGN
REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 175 GP practices across the United Kingdom (UK). The study aims to recruit 399 children aged (≥ 12 months and < 16 years) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow-up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day-14 and at 3 months.
DISCUSSION
It is unclear whether prescribing orally administered antibiotics to children with AOMd results in a reduction in symptoms or a shorter duration of illness. The REST trial should allow us to compare the non-inferiority of: immediate topically administered ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin) against immediate orally administered amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the TRANSFoRm software to randomise participants to the trial will enable recruitment for a relatively uncommon condition.
TRIAL REGISTRATION
Name of Registry: ISCRTN Registration Number: ISRCTN12873692. This contains all items required to comply with the World Health Organization Trial Registration Data Set Date of Registration: 24 April 2018 Name of Registry: EudraCT Registration Number: 2017-003635-10 Date of Registration: 6 September 2017.",2020,"Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform.","['Acute otitis media (AOM', 'Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered', 'children with AOMd', 'acute otitis media with discharge in children', '175 GP practices across the United Kingdom (UK', '399 patients from 175 practices in the UK', 'children, with around 2.8 million cases presenting to primary care in England and Wales annually', '399 children aged (≥\u200912\u2009months and\u2009<\u200916\u2009years) presenting to their GP with AOMd']","['amoxicillin (clarithromycin', 'ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin', 'immediate topically administered or delayed orally administered antibiotics', 'ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin', 'antibiotics']","['time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ', 'cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes']","[{'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004519', 'cui_str': 'Azoxymethane'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1154187', 'cui_str': 'Ear drops'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3853088', 'cui_str': 'Moderately bad'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0004519', 'cui_str': 'Azoxymethane'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",399.0,0.285734,"Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Curtis', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University Of Southampton, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Cabral', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Vasa', 'Initials': 'V', 'LastName': 'Curcin', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, Addison House 3.07, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'Jeremey', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morris', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Vibhore', 'Initials': 'V', 'LastName': 'Prasad', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, Addison House 3.07, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schilder', 'Affiliation': 'evidENT, UCL Ear Institute, Royal National Throat, Nose and Ear Hospital, 330 Grays Inn Road, London, WC1X 8DA, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Bristol Randomised Trial Collaboration (BRTC), part of the Bristol Trial Centre, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wilkes', 'Affiliation': 'School of Medicine, Faculty of Health Sciences and Wellbeing, University of Sunderland, Sciences Complex, City Campus, Chester Road, Sunderland, SR1 3SD, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trial Collaboration (BRTC), part of the Bristol Trial Centre, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK. j.taylor@bristol.ac.uk.'}]",Trials,['10.1186/s13063-020-04419-7']
2625,31820012,"Peer review: single-blind, double-blind, or all the way-blind?","A scholarly peer review is the process whereby referees scrutinize research work or a manuscript within their field of expertise and decide on its acceptability for publication in a journal or scientific proceeding. Ideally, peer review is impartial. Among the many models of peer review, the single blind is currently the most adopted model in scientific journals. The double-blind model has been claimed to decrease bias, despite some difficulty in implementation.",2020,A scholarly peer review is the process whereby referees scrutinize research work or a manuscript within their field of expertise and decide on its acceptability for publication in a journal or scientific proceeding.,[],[],[],[],[],[],,0.145548,A scholarly peer review is the process whereby referees scrutinize research work or a manuscript within their field of expertise and decide on its acceptability for publication in a journal or scientific proceeding.,"[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Bazi', 'Affiliation': 'American University of Beirut, Beirut, Lebanon. tb14@aub.edu.lb.'}]",International urogynecology journal,['10.1007/s00192-019-04187-2']
2626,32249509,Center-Based Group and Home-Based Individual Exercise Programs Have Similar Impacts on Gait and Balance in People With Multiple Sclerosis: A Randomized Trial.,"BACKGROUND
Group and home-based exercises to improve function in people with multiple sclerosis (MS) are common but have little underpinning evidence.
OBJECTIVE
To determine the comparative effectiveness of a center-based group versus home-based individual 8-week exercise program to improve gait and balance in people with MS.
DESIGN
Prospective, randomized controlled trial.
SETTING
Community center-based and home-based exercise program.
PARTICIPANTS
Fifty people with MS were randomized and completed allocated intervention (n = 26 center, n = 24 home), 47 completed post-assessment and 44 follow-up assessment.
METHODS
The center- and home-based groups completed an 8-week progressive functional and balance training exercise program. The center-based groups of four to six were supervised by a physiotherapist. The home-based group was provided with telephone support.
MAIN OUTCOME MEASUREMENTS
The primary outcome was gait speed (10-meter walk test). Secondary outcomes were gait endurance (6-minute walk test) and balance (Berg Balance Scale). Outcome assessments were conducted at baseline, immediately postintervention and at 8-week follow-up.
RESULTS
There was no statistically significant difference between groups in gait speed post training, with a mean difference of 0.01 m/s, 95% CI -0.36 to 0.37. There were no group effects, time effects, or interactions for gait speed, endurance, or balance. In both groups, gait speed improved to a level that met minimal clinically important differences.
CONCLUSIONS
Gait speed, endurance, and balance did not statistically improve in either group; however, gait speed changes met minimally important differences.",2020,,['people with Multiple Sclerosis'],['Center-based group and home-based individual exercise programs'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0203986', 'cui_str': 'Individual exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0842804,,"[{'ForeName': 'Katrina Louise', 'Initials': 'KL', 'LastName': 'Williams', 'Affiliation': 'Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Nancy Louise', 'Initials': 'NL', 'LastName': 'Low Choy', 'Affiliation': 'School of Physiotherapy, Australian Catholic University (McAuley Campus), Brisbane, Australia.'}, {'ForeName': 'Sandra Gail', 'Initials': 'SG', 'LastName': 'Brauer', 'Affiliation': 'Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12377']
2627,32493441,Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6, IL-6 receptor and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome.
TRIAL DESIGN
A phase 3 prospective, multi-center, interventional, open label, 6-arm 2x2 factorial design study.
PARTICIPANTS
Subjects will be recruited at the specialized COVID-19 wards and/or ICUs at 16 Belgian participating hospitals. Only adult (≥18y old) patients will be recruited with recent (≤16 days) COVID-19 infection and acute hypoxia (defined as PaO2/FiO2 below 350mmHg or PaO2/FiO2 below 280 on supplemental oxygen and immediately requiring high flow oxygen device or mechanical ventilation) and signs of systemic cytokine release syndrome characterized by high serum ferritin, or high D-dimers, or high LDH or deep lymphopenia or a combination of those, who have not been on mechanical ventilation for more than 24 hours before randomisation. Patients should have had a chest X-ray and/or CT scan showing bilateral infiltrates within the last 2 days before randomisation. Patients with active bacterial or fungal infection will be excluded.
INTERVENTION AND COMPARATOR
Patients will be randomized to 1 of 5 experimental arms versus usual care. The experimental arms consist of Anakinra alone (anti-IL-1 binding the IL-1 receptor), Siltuximab alone (anti-IL-6 chimeric antibody), a combination of Siltuximab and Anakinra, Tocilizumab alone (humanised anti-IL-6 receptor antibody) or a combination of Anakinra with Tocilizumab in addition to standard care. Patients treated with Anakinra will receive a daily subcutaneous injection of 100mg for a maximum of 28 days or until hospital discharge, whichever comes first. Siltuximab (11mg/kg) or Tocilizumab (8mg/kg, with a maximum dose of 800mg) are administered as a single intravenous injection immediately after randomization.
MAIN OUTCOMES
The primary end point is the time to clinical improvement defined as the time from randomization to either an improvement of two points on a six-category ordinal scale measured daily till day 28 or discharge from the hospital or death. This ordinal scale is composed of (1) Death; (2) Hospitalized, on invasive mechanical ventilation or ECMO; (3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; (4) Hospitalized, requiring supplemental oxygen; (5) Hospitalized, not requiring supplemental oxygen; (6) Not hospitalized.
RANDOMISATION
Patients will be randomized using an Interactive Web Response System (REDCap). A 2x2 factorial design was selected with a 2:1 randomization regarding the IL-1 blockade (Anakinra) and a 1:2 randomization regarding the IL-6 blockade (Siltuximab and Tocilizumab).
BLINDING (MASKING)
In this open-label trial neither participants, caregivers, nor those assessing the outcomes are blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
A total of 342 participants will be enrolled: 76 patients will receive usual care, 76 patients will receive Siltuximab alone, 76 patients will receive Tocilizumab alone, 38 will receive Anakinra alone, 38 patients will receive Anakinra and Siltuximab and 38 patients will receive Anakinra and Tocilizumab.
TRIAL STATUS
COV-AID protocol version 3.0 (15 Apr 2020). Participant recruitment is ongoing and started on April 4 th 2020. Given the current decline of the COVID-19 pandemic in Belgium, it is difficult to anticipate the rate of participant recruitment.
TRIAL REGISTRATION
The trial was registered on Clinical Trials.gov on April 1st, 2020 (ClinicalTrials.gov Identifier: NCT04330638) and on EudraCT on April 3rd 2020 (Identifier: 2020-001500-41).
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['Patients with active bacterial or fungal infection will be excluded', 'severely ill COVID-19 patients with anti-interleukin drugs (COV-AID', '342 participants will be enrolled: 76 patients will receive usual care, 76 patients will receive', '3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; (4) Hospitalized, requiring supplemental oxygen; (5) Hospitalized, not requiring supplemental oxygen; (6) Not hospitalized', 'on April 3rd 2020 (Identifier: 2020-001500-41', 'Only adult (≥18y old) patients will be recruited with recent (≤16 days', 'patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome', 'Subjects will be recruited at the specialized COVID-19 wards and/or ICUs at 16 Belgian participating hospitals']","['Interactive Web Response System (REDCap', 'Siltuximab alone', 'EudraCT', 'Anakinra alone (anti-IL-1 binding the IL-1 receptor), Siltuximab alone (anti-IL-6 chimeric antibody), a combination of Siltuximab and Anakinra, Tocilizumab alone (humanised anti-IL-6 receptor antibody) or a combination of Anakinra with Tocilizumab', 'Tocilizumab', 'individually or simultaneously blocking IL-6, IL-6 receptor and IL-1 versus standard of care', 'Siltuximab', 'invasive mechanical ventilation or ECMO', 'IL-6 blockade (Siltuximab and Tocilizumab', 'Tocilizumab alone, 38 will receive Anakinra alone, 38 patients will receive Anakinra and Siltuximab and 38 patients will receive Anakinra and Tocilizumab']","['time to clinical improvement defined as the time from randomization to either an improvement of two points on a six-category ordinal scale measured daily till day 28 or discharge from the hospital or death', 'COVID-19 infection and acute hypoxia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1609931', 'cui_str': 'siltuximab'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0008109', 'cui_str': 'Chimera'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",342.0,0.275166,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium. bastiaan.maes@irc.vib-ugent.be.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Willaert', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bollé', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vanbiervliet', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Decuypere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Libeer', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Lambrecht', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04453-5']
2628,31922432,Prophylactic Effects of Intravenous Dexamethasone and Lidocaine on Attenuating Hemodynamic-Respiratory and Pain Complications in Children Undergoing Cleft Palate Repair Surgery With General Anesthesia.,"This study aimed to compare the prophylactic effects of intravenous (IV) dexamethasone and lidocaine on hemodynamic condition, respiratory complications, pain control, and vomit incidence following cleft palate repair surgery. This double-blind randomized controlled trial was carried out on 87 children assigned to three groups. Prior to anesthesia, subjects in groups D and L received 0.2 and 1 mg/kg IV dexamethasone and lidocaine, respectively. Moreover, group C received placebo in a similar condition. The outcome variables were recorded prior to the surgery and then every 15 minutes during the surgical and recovery time. Mean heart rate (HR), mean arterial blood pressure (MABP), and mean end-tidal carbon dioxide (ETCO2) during the surgical time were not significantly different between dexamethasone and lidocaine groups. Dexamethasone significantly improved the level of blood oxygen saturation (SPO2) during the recovery time. Nevertheless, MABP in recovery time did not significantly decrease in the dexamethasone group. There were no significant differences in respiratory complications, pain score, and vomiting incidence between lidocaine and dexamethasone groups. Premedication with both IV dexamethasone and lidocaine provided similar stable hemodynamic and respiratory conditions during the surgical time. However, the use of dexamethasone developed more desirable effects on HR and SPO2 than administration of lidocaine during the recovery time. Both drugs significantly lessened postoperative pain compared to the placebo group at this time.",2020,"There were no significant differences in respiratory complications, pain score, and vomiting incidence between lidocaine and dexamethasone groups.","['87 children assigned to three groups', 'cleft palate repair surgery', 'Children Undergoing Cleft Palate Repair Surgery']","['Dexamethasone', 'Dexamethasone and Lidocaine', 'placebo', 'intravenous (IV) dexamethasone and lidocaine', 'dexamethasone', 'lidocaine', 'dexamethasone and lidocaine']","['MABP in recovery time', 'postoperative pain', 'level of blood oxygen saturation (SPO2', 'Mean heart rate (HR), mean arterial blood pressure (MABP), and mean end-tidal carbon dioxide (ETCO2) during the surgical time', 'Hemodynamic-Respiratory and Pain Complications', 'respiratory complications, pain score, and vomiting incidence', 'stable hemodynamic and respiratory conditions', 'hemodynamic condition, respiratory complications, pain control, and vomit incidence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0192086', 'cui_str': 'Uranorrhaphy for cleft palate repair (procedure)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}]",87.0,0.154139,"There were no significant differences in respiratory complications, pain score, and vomiting incidence between lidocaine and dexamethasone groups.","[{'ForeName': 'Dorna', 'Initials': 'D', 'LastName': 'Kheirabadi', 'Affiliation': 'Dorna Kheirabadi, MD, is with the Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Amir Shafa is with the Department of Anesthesiology, Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Anahita Hirmanpour is with the Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Fatemeh Zareh, MD, is with the School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Shafa', 'Affiliation': 'Dorna Kheirabadi, MD, is with the Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Amir Shafa is with the Department of Anesthesiology, Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Anahita Hirmanpour is with the Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Fatemeh Zareh, MD, is with the School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Hirmanpour', 'Affiliation': 'Dorna Kheirabadi, MD, is with the Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Amir Shafa is with the Department of Anesthesiology, Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Anahita Hirmanpour is with the Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Fatemeh Zareh, MD, is with the School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Zareh', 'Affiliation': 'Dorna Kheirabadi, MD, is with the Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Amir Shafa is with the Department of Anesthesiology, Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Anahita Hirmanpour is with the Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Fatemeh Zareh, MD, is with the School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of pain & palliative care pharmacotherapy,['10.1080/15360288.2019.1706691']
2629,31397487,Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial.,"AIMS
To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI).
METHODS AND RESULTS
In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011).
CONCLUSION
Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.",2019,"The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011).
","['patients with complex PCI', 'patients who underwent complex percutaneous coronary intervention', '12-month DAPT) after complex percutaneous coronary intervention (PCI', '15\xa0450 patients included in this analysis, 4570 who underwent']","['ticagrelor monotherapy', 'complex PCI', 'antiplatelet therapy (DAPT', 'long-term ticagrelor monotherapy', 'Ticagrelor monotherapy']","['risk of BARC Type 3 or 5 bleeding', 'cause death or new Q-wave myocardial infarction (MI', 'risk of ischaemic and bleeding events', 'patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}]",,0.265148,"The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011).
","[{'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, Guy Scadding Building, Dovehouse St, Chelsea, London, UK.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Molewaterplein 40, GD Rotterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Molewaterplein 40, GD Rotterdam, The Netherlands.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Komiyama', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Soliman', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Molewaterplein 40, GD Rotterdam, The Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Ferrario', 'Affiliation': 'Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Viale Camillo Golgi, 19, Pavia PV, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dominici', 'Affiliation': 'Department of Cardiology, Azienda Ospedaliera S. Maria, Viale Tristano di Joannuccio, Terni TR, Italy.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Center for Cardiovascular Research and Development, American Heart of Poland, Sanatoryjna 1, Ustroń, Poland.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Via Pietro Nenni, 20/22, 52100 Arezzo, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Tumscitz', 'Affiliation': 'Department of Cardiology, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro, 8, Cona FE, Italy.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Stadsomvaart 11, 3500 Hasselt, Belgium and Faculty of Medicine and Life Sciences, University of Hasselt, Martelarenlaan 42, Hasselt, Belgium.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Europe, Rue de Lausanne 29, Morges, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Clinic and Thoraxcenter of the University of Giessen, Benekestraße 2-8, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, French Alliance for Cardiovascular Trials, Paris, France.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Molewaterplein 40, GD Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, 209 Victoria St, Toronto, ON, Canada.""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 4, Bern, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Stadsomvaart 11, 3500 Hasselt, Belgium and Faculty of Medicine and Life Sciences, University of Hasselt, Martelarenlaan 42, Hasselt, Belgium.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Department of Cardiology, Maria Cecilia Hospital-GVM, Via Madonna di Genova, 1, Cotignola RA, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 4, Bern, Switzerland.'}]",European heart journal,['10.1093/eurheartj/ehz453']
2630,32245747,Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615.,,2020,,[],['Mobile Closed-Loop Control'],[],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.138398,,"[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Kovatchev', 'Affiliation': ''}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': ''}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': ''}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': ''}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Buckingham', 'Affiliation': ''}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': ''}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': ''}, {'ForeName': 'Vikash', 'Initials': 'V', 'LastName': 'Dadlani', 'Affiliation': ''}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': ''}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': ''}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': ''}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lum', 'Affiliation': ''}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-er06']
2631,23162394,Comparison of three supraglottic devices in anesthetised paralyzed children undergoing elective surgery.,"CONTEXT
The newest variation of the i-gel supraglottic airway is a pediatric version.
AIMS
This study was designed to investigate the usefulness of the size 2 i-gel compared with the ProSeal laryngeal mask airway (PLMA) and classic laryngeal mask airway (cLMA) of the same size in anesthetized, paralyzed children.
SETTINGS AND DESIGN
A prospective, randomized, single-blinded study was conducted in a tertiary care teaching hospital.
METHODS
Ninety ASA grade I-II patients undergoing lower abdominal, inguinal and orthopedic surgery were included in this prospective study. The patients were randomly assigned to the i-gel, PLMA and cLMA groups (30 patients in each group). Size 2 supraglottic airway was inserted according to the assigned group. We assessed ease of insertion, hemodynamic data, oropharyngeal sealing pressure and postoperative complications.
RESULTS
There were no differences in the demographic and hemodynamic data among the three groups. The airway leak pressure of the i-gel group (27.1±2.6 cmH(2)O) was significantly higher than that of the PLMA group (22.73±1.2 cmH(2)O) and the cLMA group (23.63±2.3 cmH(2)O). The success rates for first attempt of insertion were similar among the three devices. There were no differences in the incidence of postoperative airway trauma, sore throat or hoarse cry in the three groups.
CONCLUSIONS
Hemodynamic parameters, ease of insertion and postoperative complications were comparable among the i-gel, PLMA and cLMA groups, but airway sealing pressure was significantly higher in the i-gel group.",2012,"There were no differences in the incidence of postoperative airway trauma, sore throat or hoarse cry in the three groups.
","['anesthetised paralyzed children undergoing elective surgery', 'Ninety ASA grade', 'I-II patients undergoing lower abdominal, inguinal and orthopedic surgery', 'anesthetized, paralyzed children']","['ProSeal laryngeal mask airway (PLMA) and classic laryngeal mask airway (cLMA', 'PLMA', 'PLMA and cLMA']","['airway sealing pressure', 'incidence of postoperative airway trauma, sore throat or hoarse cry', 'insertion and postoperative complications', 'ease of insertion, hemodynamic data, oropharyngeal sealing pressure and postoperative complications', 'success rates', 'demographic and hemodynamic data', 'airway leak pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}]","[{'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1301659', 'cui_str': 'Airway trauma'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}]",90.0,0.063196,"There were no differences in the incidence of postoperative airway trauma, sore throat or hoarse cry in the three groups.
","[{'ForeName': 'Bikramjit', 'Initials': 'B', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Subhro', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': ''}, {'ForeName': 'Shahin N', 'Initials': 'SN', 'LastName': 'Jamil', 'Affiliation': ''}, {'ForeName': 'Rohit K', 'Initials': 'RK', 'LastName': 'Varshney', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.101212']
2632,32494128,Effect of HFE Gene Mutation on Changes in Iron Metabolism Induced by Nordic Walking in Elderly Women.,"Background
Excess iron accumulation in human tissue is associated with the diet, lack of exercise, or genetic factors. Iron accumulation increases the risk of acute myocardial infarction, diabetes, and cancer. On the other hand, exercise reduces the risk of several morbidities and influences iron metabolism. Here, we evaluated changes in iron metabolism induced by exercise in elderly women bearing the H63A HFE mutation.
Purpose
To identify a factor that modulates the effect of exercise on iron metabolism. We investigated whether regular exercise induces similar changes in iron metabolism, mainly manifested by lowered body iron stores, in individuals bearing the wild-type (WT) and mutated HFE gene.
Subjects and Methods
Seventy-six women (average age 69.2±5.6 years old) were enrolled in the study. Thirty-nine women participated in 12 weeks of Nordic walking (NW) training; the remaining participants were assigned to the control group. Based on the H63A HFE mutation status, the NW group was divided into women bearing the mutation (HET, n=12) and women with the WT gene (WT, n=27).
Results
The training resulted in a statistically significant reduction in the serum iron (p=0.03) and ferritin levels (p=0.001); hepcidin levels remained unchanged. No differences in these parameters were noted between the HET and WT groups.
Conclusion
These observations suggest that a reduction in body iron stores might constitute an important aspect of the health-promoting effect of exercise, regardless of the genetic background.",2020,The training resulted in a statistically significant reduction in the serum iron (p=0.03) and ferritin levels (p=0.001); hepcidin levels remained unchanged.,"['Subjects and Methods\n\n\nSeventy-six women (average age 69.2±5.6 years old', 'Elderly Women', 'individuals bearing the wild-type (WT) and mutated HFE gene', 'Thirty-nine women participated in 12 weeks of', 'H63A HFE mutation status, the NW group was divided into women bearing the mutation (HET, n=12) and women with the WT gene (WT, n=27', 'elderly women bearing the H63A HFE mutation']","['regular exercise', 'Nordic walking (NW) training', 'HFE Gene Mutation']","['serum iron', 'hepcidin levels', 'risk of acute myocardial infarction, diabetes, and cancer', 'risk of several morbidities and influences iron metabolism', 'ferritin levels']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0898753', 'cui_str': 'SAFB protein, human'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}]",39.0,0.0512592,The training resulted in a statistically significant reduction in the serum iron (p=0.03) and ferritin levels (p=0.001); hepcidin levels remained unchanged.,"[{'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Kortas', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sport, Gdansk, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Ziemann', 'Affiliation': 'Department of Athletics, Strength and Conditioning, Poznan University of Physical Education, Poznan, Poland.'}, {'ForeName': 'Jedrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Department of Bioenergetics and Physiology of Exercise, Medical University of Gdansk, Gdansk, Poland.'}]",Clinical interventions in aging,['10.2147/CIA.S252661']
2633,32493780,Accuracy of Xpert Ultra in the diagnosis of pulmonary tuberculosis among children in Uganda: a sub-study from the SHINE trial.,"Background: Childhood tuberculosis presents significant diagnostic challenges associated with paucibacillary disease, and requires a more sensitive test. We evaluated the diagnostic accuracy of XpertMTB/Rif Ultra (Ultra) compared to other microbiological tests using respiratory samples from Ugandan children in the SHINE trial. Design/Methods: SHINE is a randomized trial evaluating shorter treatment in 1204 children with minimal TB disease in Africa/India. Among 352 samples and one cervical lymph node fine needle aspirate, one sample was randomly selected per patient and tested with Xpert MTB/Rif (Xpert), Lowenstein Jensen (LJ) and liquid (MGIT) cultures. We selected only uncontaminated stored sample pellet for Ultra testing. We estimated sensitivity of Xpert and Ultra against culture and a composite microbiological reference standard (any positive result). Results: Of 398 children, 353 (89%) had culture, Xpert and Ultra results. Median age was 2.8-years (IQR 1.3-5.3); 8.5% (30/353) HIV-infected, 54.4% (192/353) male. 31/353 (9%) were positive by LJ and/or MGIT; 36 (10%) by Ultra and 16 (5%) by Xpert. Sensitivities were (%; 95% CI), 58% (39-65% (18/31)) for Ultra and 45% (27-64% (14/31)) for Xpert against any culture-positive, with false-positives of <1% and 5.5% for Xpert and Ultra. Against a composite microbiological reference, sensitives were 72% (58-84% (36/50) for Ultra, and 32% (20-47% (16/50)) for Xpert. However, there were 17 samples that are positive only on Ultra (majority trace). Conclusions: Among children screened for minimal TB in Uganda, Ultra has higher sensitivity than Xpert. This represents an important advance for a condition which has posed a diagnostic challenge for decades.",2020,"Sensitivities were (%; 95% CI), 58% (39-65% (18/31)) for Ultra and 45% (27-64% (14/31)) for Xpert against any culture-positive, with false-positives of <1% and 5.5% for Xpert and Ultra.","['Ugandan children in the SHINE trial', '1204 children with minimal TB disease in Africa/India', '398 children, 353 (89%) had culture, Xpert and Ultra results', 'Among 352 samples and one cervical lymph node fine needle aspirate, one sample was randomly selected per patient and tested with', 'Median age was 2.8-years (IQR 1.3-5.3); 8.5% (30/353) HIV-infected, 54.4% (192/353) male', 'pulmonary tuberculosis among children in Uganda']","['Xpert MTB/Rif (Xpert), Lowenstein Jensen (LJ) and liquid (MGIT) cultures', 'XpertMTB/Rif Ultra (Ultra', 'Xpert Ultra']",['Sensitivities'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C1280568', 'cui_str': 'Specimen obtained by fine needle aspiration procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",1204.0,0.137987,"Sensitivities were (%; 95% CI), 58% (39-65% (18/31)) for Ultra and 45% (27-64% (14/31)) for Xpert against any culture-positive, with false-positives of <1% and 5.5% for Xpert and Ultra.","[{'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Ssengooba', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, P.O.BOX 7072, Kampala, Uganda Willyssengooba@gmail.com.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'de Dieu Iragena', 'Affiliation': 'Communicable Diseases Cluster, HIV/TB and Hepatitis Programme, World Health Organization Regional Office for Africa, Brazzaville, Congo.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Nakiyingi', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'Serestine', 'Initials': 'S', 'LastName': 'Mujumbi', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, P.O.BOX 7072, Kampala, Uganda.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wobudeya', 'Affiliation': 'Makerere University, John Hopkins University, Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mboizi', 'Affiliation': 'Makerere University, John Hopkins University, Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boulware', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Choo', 'Affiliation': 'MRC Clinical Trials Unit, University College London (UCL), London, United Kingdom.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Crook', 'Affiliation': 'MRC Clinical Trials Unit, University College London (UCL), London, United Kingdom.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lebeau', 'Affiliation': 'MRC Clinical Trials Unit, University College London (UCL), London, United Kingdom.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Joloba', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, P.O.BOX 7072, Kampala, Uganda.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Demers', 'Affiliation': 'Desmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Fiona V', 'Initials': 'FV', 'LastName': 'Cresswell', 'Affiliation': 'Makerere University, John Hopkins University, Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'MRC Clinical Trials Unit, University College London (UCL), London, United Kingdom.'}]",Journal of clinical microbiology,['10.1128/JCM.00410-20']
2634,32493872,Effect of Music Therapy on the Chronic Pain and Midterm Quality of Life of Patients after Mechanical Valve Replacement.,"OBJECTIVE
To evaluate the effect of music therapy on the chronic pain and midterm quality of life of patients after mechanical valve replacement.
METHODS
Patients were divided into two groups according to whether or not they received music therapy. The patients in the music group received 30 minutes of music therapy every day for 6 months after the operation. The patients in the control group received standard treatment and had 30 minutes of quiet rest time every day in the same period. The short-form of McGill Pain Questionnaire (SF-MPQ) was used to evaluate the degree of postoperative chronic pain, and the SF-36 was used to evaluate the midterm quality of life of patients.
RESULTS
In terms of the degree of postoperative chronic pain, the score of the pain rating index (PRI) emotional item in the music group was significantly lower than that in the control group. In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
CONCLUSION
This study preliminarily showed that music therapy can effectively reduce chronic pain and improve midterm quality of life after surgery.",2020,"In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
","['Patients after Mechanical Valve Replacement', 'Patients', 'patients after mechanical valve replacement']","['music therapy', 'standard treatment and had 30 minutes of quiet rest time', 'Music Therapy']","['chronic pain', 'emotional function score', 'chronic pain and midterm quality of life', 'postoperative chronic pain, the score of the pain rating index (PRI) emotional item', 'midterm quality of life', 'Chronic Pain and Midterm Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0493251,"In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
","[{'ForeName': 'Ze-Wei', 'Initials': 'ZW', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Liang-Wan', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.20-00022']
2635,32493881,Efficacy and Safety of Prasugrel by Stroke Subtype: A Sub-Analysis of the PRASTRO-I Randomized Controlled Trial.,"AIMS
The efficacy of antiplatelet therapy may vary among different disease subtypes. Prasugrel is generally a more potent, consistent, and fast-acting platelet inhibitor than clopidogrel. This sub-analysis of the phase III comparison of PRAsugrel and clopidogrel in Japanese patients with ischemic STROke (PRASTRO-I) trial aimed to assess the differences in efficacy of these treatments for each stroke subtype.
METHODS
In the PRASTRO-I trial, a total of 3,753 patients with ischemic stroke were recruited from 224 centers throughout Japan and randomized (1:1) to prasugrel (3.75 mg/day) or clopidogrel (75 mg/day) for 96 weeks. For the sub-analysis, strokes were classified as large-artery atherosclerosis, small-artery occlusion (lacunar), stroke of other etiology, and stroke of undetermined etiology. The cumulative incidence of primary events (ischemic stroke, myocardial infarction, and death from other vascular cause) and hazard ratios (HRs) were calculated for each subgroup.
RESULTS
For patients with large-artery atherosclerosis, the primary event incidence was 3.8% in the prasugrel group and 4.8% in the clopidogrel group (HR 0.79; 95% confidence interval [CI] 0.45-1.40). For patients with small-artery occlusion, the incidence was 3.3% in the prasugrel group and 3.9% in the clopidogrel group (HR 0.83; 95% CI 0.46-1.53). For patients with stroke of undetermined etiology, the incidence was 4.6% in the prasugrel group and 3.0% in the clopidogrel group (HR 1.56; 95% CI 0.90-2.72). The incidence of bleeding was similar across subtypes.
CONCLUSIONS
Although statistical significance was not reached, the efficacy of prasugrel was potentially different between stroke subtypes, warranting further studies.",2020,"The cumulative incidence of primary events (ischemic stroke, myocardial infarction, and death from other vascular cause) and hazard ratios (HRs) were calculated for each subgroup.
","['3,753 patients with ischemic stroke were recruited from 224 centers throughout Japan and randomized (1:1) to', 'Japanese patients with ischemic STROke', 'by Stroke Subtype']","['Prasugrel', 'PRAsugrel and clopidogrel', 'clopidogrel', 'prasugrel']","['cumulative incidence of primary events (ischemic stroke, myocardial infarction, and death from other vascular cause) and hazard ratios (HRs', 'Efficacy and Safety', 'incidence of bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",3753.0,0.16897,"The cumulative incidence of primary events (ischemic stroke, myocardial infarction, and death from other vascular cause) and hazard ratios (HRs) were calculated for each subgroup.
","[{'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine.""}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Neurology, Nippon Medical School, Tama-Nagayama Hospital.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamagami', 'Affiliation': 'Department of Stroke Neurology, National Hospital Organization Osaka National Hospital.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Tanahashi', 'Affiliation': 'Department of Neurology, Saitama Medical University International Medical Center.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Neurology, Sakai City Medical Center.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Nagata', 'Affiliation': 'Department of Neurosurgery, Kokura Memorial Hospital.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Nishikawa', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nanto', 'Affiliation': 'Nishinomiya Municipal Central Hospital.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Waseda University Faculty of Science and Engineering.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Shirai', 'Affiliation': 'Clinical Development Department, R&D Division, Daiichi Sankyo Co., Ltd.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Biostatistics & Data Management Department, R&D Division, Daiichi Sankyo Co., Ltd.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ogawa', 'Affiliation': 'Department of Neurosurgery, Iwate Medical University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.56093']
2636,32494060,The effect of Virtual Reality on evoked potentials following painful electrical stimuli and subjective pain.,"BACKGROUND
Virtual reality (VR) has been shown to reduce pain, however outcome parameters of previous studies have primarily been of a subjective nature and susceptible to bias. This study investigated the effect of VR on cortical processing of evoked potentials (EPs) and subjectively reported pain. Additionally, we explored whether subjects' demographic and personal characteristics modulated the effect of VR analgesia.
METHODS
Three VR conditions were compared in a randomized cross-over study of 30 healthy volunteers: Passive VR (i.e. no interaction possible with the virtual world), active VR (interactive virtual environment) and no VR (black screen). Subjects received noxious electrical stimuli at random intervals during all conditions. EPs, recorded at Cz, were extracted time locked to stimuli. Pain scores were reported after each condition.
RESULTS
Active VR significantly decreased pain scores and amplitudes of N1 and P3. Passive VR had no analgesic effect. Age was significantly correlated to pain scores, with older subjects demonstrating larger effects of VR. Gender, game experience, and susceptibility for immersion, did not influence VR analgesia.
CONCLUSION
Active VR decreases pre-perceptual and perceptual brain activity following painful electrical stimuli, corresponding with reduced pain experience. VR has potential to serve as a non-pharmacologic treatment for pain, particularly in elderly patients.",2020,"RESULTS
Active VR significantly decreased pain scores and amplitudes of N1 and P3.","['elderly patients', '30 healthy volunteers']","['noxious electrical stimuli', 'VR', 'Virtual Reality', 'Passive VR (i.e. no interaction possible with the virtual world), active VR (interactive virtual environment) and no VR (black screen']","['pain scores', 'pain scores and amplitudes of N1 and P3', 'Active VR decreases pre-perceptual and perceptual brain activity', 'Pain scores', 'cortical processing of evoked potentials (EPs) and subjectively reported pain']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0186764,"RESULTS
Active VR significantly decreased pain scores and amplitudes of N1 and P3.","[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Lier', 'Affiliation': 'Department of Surgery, Radboud university medical center Nijmegen, Nijmegen, The Netherlands. janienkelier@gmail.com.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Oosterman', 'Affiliation': 'Radboud University, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Assmann', 'Affiliation': 'Department of Surgery, Radboud university medical center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Vries', 'Affiliation': 'Department of Surgery, Radboud university medical center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': 'Department of Surgery, Radboud university medical center Nijmegen, Nijmegen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-66035-4']
2637,32494269,Acute effects of Zamzam water on blood pressure and heart rate variability.,"Objective
There is a lack of studies exploring the effects of Zamzam water on human physiology. The present study determined the effects of Zamzam water on blood pressure and heart rate variability (HRV).
Methods
This comparative interventional study was conducted at the Department of Physiology, of our university in March 2018. A total number of 97 female subjects drank 500 ml of either Zamzam water or mineral water in one minute. Finometer Pro and PowerLab (ADInstruments R ) with ECG electrodes through bioamplifier and attached finger pulse transducer were used to collect data at the baseline (for five minutes), during (for one minute) and after the drink (for five minutes). Paired and uunpaired student's t-test, one-way ANCOVA and one-way repeated measure ANOVA were used for analysis. Blood pressure parameters were followed minute by minute and HRV parameters were compared as a 5-minute of baseline segment to 5-minute post drink segment.
Results
Within-the-group comparison exhibited significant increases in blood pressure parameters (systolic, diastolic, pulse and mean arterial pressure), over a 5-minute post-drinking period in both groups. Zamzam water caused a significant increase in SDRR (an indication of overall HRV) and RMSSD (an indication of vagal activity) as compared to baseline.
Conclusion
Both drinks cause a significant increase in systolic, diastolic, pulse and mean arterial pressure within five minutes post-drinking period. Zamzam water produce a significant increase in cardiac vagal tone but has no effect on cardiac sympathetic activity. Mineral water has no significant effect on both, cardiac vagal and sympathetic activity.",2020,"Both drinks cause a significant increase in systolic, diastolic, pulse and mean arterial pressure within five minutes post-drinking period.","['Department of Physiology, of our university in March 2018', '97 female subjects drank 500 ml of either Zamzam water or mineral water in one minute']","['Zamzam', 'Finometer Pro and PowerLab (ADInstruments R ) with ECG electrodes through bioamplifier and attached finger pulse transducer']","['blood pressure parameters (systolic, diastolic, pulse and mean arterial pressure', 'SDRR', 'Blood pressure parameters', 'systolic, diastolic, pulse and mean arterial pressure', 'cardiac sympathetic activity', 'cardiac vagal and sympathetic activity', 'cardiac vagal tone', 'blood pressure and heart rate variability', 'blood pressure and heart rate variability (HRV']","[{'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0026157', 'cui_str': 'Mineral water'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.021514,"Both drinks cause a significant increase in systolic, diastolic, pulse and mean arterial pressure within five minutes post-drinking period.","[{'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Latif', 'Affiliation': 'Rabia Latif, PhD. Associate Professor, Department of Physiology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Farrukh', 'Initials': 'F', 'LastName': 'Majeed', 'Affiliation': 'Farrukh Majeed, FCPS. Professor, Department of Physiology, Al Tibri Medical College, Karachi, Pakistan.'}, {'ForeName': 'Ahmed Al', 'Initials': 'AA', 'LastName': 'Sunni', 'Affiliation': 'Ahmed Al Sunni, PhD. Associate Professor, Department of Physiology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Rahmah Mohammed K', 'Initials': 'RMK', 'LastName': 'ALamrie', 'Affiliation': 'Rahmah Mohammed K ALamrie, Medical Student, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Shaykhah Nasser', 'Initials': 'SN', 'LastName': 'AlNaimi', 'Affiliation': 'Shaykhah Nasser AlNaimi, Medical Student, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.4.1755']
2638,32494283,Endoscopic thyroid lobectomy vs Conventional open thyroid lobectomy.,"Background and Objective
Surgical managements for these suspicious nontoxic swellings requires open conventional method of thyroidectomy by neck incisions that can result in prominent scars and immediate risk usually hemorrhage. However new technological innovations came into practiced that include video assisted minimal invasive endoscopy by axillo-breast approach that gives very promising results with excellent cosmesis. In this study, we compared conventional open surgery with minimal invasive endoscopic techniques and associate various complaints and complications that were encountered in surgery.
Methods
Sixty patients were enrolled in this comparative study. It was conducted from period February 2018 to February 2019. The patients were randomized alternatively in two groups. Group-I patients underwent conventional lobectomy while Group-II patients were operated endoscopically, Patients having nodules less than 3cm and Thy 1 and 2 were included in this study. Patient having nodules greater than 3cm, Multinodular goiter, recurrent nodule and Thy 3-6 were excluded from the study.
Results
Patients who underwent endoscopic lobectomy were much more satisfied about scar marks whereas some developed post-operative complications. It included hoarseness of voice in Three (13.62%) patients, two patients developed seroma (9.08%), three patients (13.62%) erythema, whereas no postoperative complications were seen in patients who underwent open thyroid lobectomy. No signs of hypocalcemia noted in both approaches.
Conclusions
The complications with endoscopic approaches are higher but they are minor and resolved spontaneously within maximum period of six weeks. However scar mark satisfaction was much higher in endoscopic lobectomy group.",2020,"No signs of hypocalcemia noted in both approaches.
","['Patients having nodules less than 3cm and Thy 1 and 2 were included in this study', 'Patient having nodules greater than 3cm, Multinodular goiter, recurrent nodule and Thy 3-6 were excluded from the study', 'Methods\n\n\nSixty patients']","['conventional open surgery with minimal invasive endoscopic techniques', 'conventional lobectomy', 'Endoscopic thyroid lobectomy vs Conventional open thyroid lobectomy', 'endoscopic lobectomy']","['hypocalcemia', 'seroma', 'postoperative complications', 'scar mark satisfaction', 'satisfied about scar marks', 'hoarseness of voice']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0342208', 'cui_str': 'Multinodular goiter'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}]",60.0,0.0169575,"No signs of hypocalcemia noted in both approaches.
","[{'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Imran', 'Affiliation': 'Dr. Mariam Imran, Department of Surgery Ward 25, Jinnah Postgraduate Medical Center, Karachi, Pakistan.'}, {'ForeName': 'Zahid', 'Initials': 'Z', 'LastName': 'Mehmood', 'Affiliation': 'Dr. Zahid Mehmood, FCPS FRCS FACS. Department of Surgery Ward 25, Jinnah Postgraduate Medical Center, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Naseem', 'Initials': 'MN', 'LastName': 'Baloch', 'Affiliation': 'Dr. Muhammad Naseem Baloch, FCPS FACS. Department of Surgery Ward 25, Jinnah Postgraduate Medical Center, Karachi, Pakistan.'}, {'ForeName': 'Sehrish', 'Initials': 'S', 'LastName': 'Altaf', 'Affiliation': 'Dr. Sehrish Altaf, Department of Surgery Ward 25, Jinnah Postgraduate Medical Center, Karachi, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.4.1604']
2639,32494465,The Use of Electronic Personal Health Records to Improve Medication Adherence and Patient Engagement: A Randomized Study of Non-valvular Atrial Fibrillation Patients.,"Embolic stroke is a major complication of atrial fibrillation (AF) that frequently results in disability or death. The administration of oral anticoagulation can reduce stroke risk in AF patients; however, medication non-adherence can eliminate this benefit. To date, reported patient adherence rates to oral anticoagulation regimens vary. The objective of the current study was to examine the impact of medication-specific education delivered via a personal health record (PHR) system on medication adherence. A randomized, prospective study was conducted from February 2014 to June 2014 at Parkview Health, a not-for-profit, community-based health care clinic that serves a northeastern Indiana population of more than 820,000. AF patients receiving dabigatran (Pradaxa ® ; Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany) to prevent stroke participated in this study. The study participants were predominantly Caucasian males over 65 years of age who were educated, insured, and living above the poverty level. Patients were allowed to view online, download, and transmit health information via a PHR. The intervention group received PHR training and dabigatran education via the PHR. The control group received standard care and PHR access without training. A longitudinal survey pertaining to medication knowledge, medication adherence, and patient engagement was administered at baseline and at the end of the study. Medication-dispensing data collected from pharmacy refill prescriptions were used for calculating the medication possession ratio (MPR). Ninety patients were included in this study, and were randomly assigned to either the intervention group (n = 46) or the control group (n = 44). All participants completed the baseline survey, and 95.6% of patients finished the follow-up survey. The mean score for knowledge increased significantly in the intervention group (from 3.77 to 4.23, p = 0.005), but not in the control group (from 3.70 to 3.95, p = 0.72). The MPR was significantly higher in the intervention group (97.47% vs. 87.67%, p = 0.001). Both groups had similar levels of improvement in Patient Activation Measure scores (from 63.0 to 65.8, p = 0.078 vs. from 63.1 to 63.6, p = 0.814). Patients who used the PHR achieved greater medication knowledge, resulting in improved medication adherence. To our knowledge, no published randomized trial has reported on the use of PHRs to improve medication adherence and knowledge. This study is the first to demonstrate a positive impact on anticoagulation adherence with PHR use.",2017,"The mean score for knowledge increased significantly in the intervention group (from 3.77 to 4.23, p = 0.005), but not in the control group (from 3.70 to 3.95, p = 0.72).","['Non-valvular Atrial Fibrillation Patients', 'study participants were predominantly Caucasian males over 65 years of age who were educated, insured, and living above the poverty level', 'AF patients', 'AF patients receiving', 'February 2014 to June 2014 at Parkview Health, a not-for-profit, community-based health care clinic that serves a northeastern Indiana population of more than 820,000', 'Ninety patients']","['dabigatran (Pradaxa ® ', 'oral anticoagulation', 'PHR training and dabigatran education via the PHR', 'standard care and PHR access without training', 'medication-specific education delivered via a personal health record (PHR) system']","['medication knowledge', 'Patient Activation Measure scores', 'stroke risk', 'medication possession ratio (MPR', 'Medication Adherence and Patient Engagement', 'mean score for knowledge', 'MPR', 'medication adherence']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C2940579', 'cui_str': 'Pradaxa'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018739', 'cui_str': 'Personal Health Records'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4075848', 'cui_str': 'Patient Activation Measure score'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0415474,"The mean score for knowledge increased significantly in the intervention group (from 3.77 to 4.23, p = 0.005), but not in the control group (from 3.70 to 3.95, p = 0.72).","[{'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Amelia E', 'Initials': 'AE', 'LastName': 'Roebuck', 'Affiliation': 'Parkview Research Center, Parkview Health System, Fort Wayne, IN.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'Sami', 'Affiliation': 'Parkview Research Center, Parkview Health System, Fort Wayne, IN.'}, {'ForeName': 'Özlem H', 'Initials': 'ÖH', 'LastName': 'Ersin', 'Affiliation': 'College of Health and Behavioral Studies, James Madison University, Harrisonburg, VA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mirro', 'Affiliation': 'Parkview Research Center, Parkview Health System, Fort Wayne, IN.'}]",The Journal of innovations in cardiac rhythm management,['10.19102/icrm.2017.080803']
2640,32494572,Repeat assessment of examination signs among children in Malawi with fast-breathing pneumonia.,"Background
As part of a randomised controlled trial of treatment with placebo versus 3 days of amoxicillin for nonsevere fast-breathing pneumonia among Malawian children aged 2-59 months, a subset of children was hospitalised for observation. We sought to characterise the progression of fast-breathing pneumonia among children undergoing repeat assessments to better understand which children do and do not deteriorate.
Methods
Vital signs and physical examination findings, including respiratory rate, arterial oxygen saturation measured by pulse oximetry ( S pO 2 ), chest indrawing and temperature were assessed every 3 h for the duration of hospitalisation. Children were assessed for treatment failure during study visits on days 1, 2, 3 and 4.
Results
Hospital monitoring data from 436 children were included. While no children had S pO 2 90-93% at baseline, 7.4% (16 of 215) of children receiving amoxicillin and 9.5% (21 of 221) receiving placebo developed S pO 2 90-93% during monitoring. Similarly, no children had chest indrawing at enrolment, but 6.6% (14 of 215) in the amoxicillin group and 7.2% (16 of 221) in the placebo group went on to develop chest indrawing during hospitalisation.
Conclusion
Repeat monitoring of children with fast-breathing pneumonia identified vital and physical examination signs not present at baseline, including S pO 2 90-93% and chest indrawing. This information may support providers and policymakers in developing guidance for care of children with nonsevere pneumonia.",2020,"While no children had S pO 2 90-93% at baseline, 7.4% (16 of 215) of children receiving amoxicillin and 9.5% (21 of 221) receiving placebo developed S pO 2 90-93% during monitoring.","['children undergoing repeat assessments', '436 children were included', 'Malawian children aged 2-59\u2005months, a subset of children was hospitalised for observation', 'children in Malawi with fast-breathing pneumonia', 'children with nonsevere pneumonia']","['amoxicillin', 'placebo', 'placebo versus 3\u2005days of amoxicillin']","['nonsevere fast-breathing pneumonia', 'respiratory rate, arterial oxygen saturation measured by pulse oximetry ( S pO 2 ), chest indrawing and temperature']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",436.0,0.0777659,"While no children had S pO 2 90-93% at baseline, 7.4% (16 of 215) of children receiving amoxicillin and 9.5% (21 of 221) receiving placebo developed S pO 2 90-93% during monitoring.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Lenahan', 'Affiliation': 'International Programs, Save the Children Federation Inc., Westport, CT, USA.'}, {'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'International Programs, Save the Children Federation Inc., Westport, CT, USA.'}, {'ForeName': 'Melda', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'Dept of Pediatrics, University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Lilongwe, Malawi.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'Dept of Pediatrics, University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Lilongwe, Malawi.'}, {'ForeName': 'Mari T', 'Initials': 'MT', 'LastName': 'Couasnon', 'Affiliation': 'International Programs, Save the Children Federation Inc., Westport, CT, USA.'}, {'ForeName': 'Kali', 'Initials': 'K', 'LastName': 'Turner', 'Affiliation': 'International Programs, Save the Children Federation Inc., Westport, CT, USA.'}, {'ForeName': 'Chifundo', 'Initials': 'C', 'LastName': 'Ndamala', 'Affiliation': 'Dept of Pediatrics, University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Lilongwe, Malawi.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Dept of Pediatrics, Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'Dept of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amy Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'International Programs, Save the Children Federation Inc., Westport, CT, USA.'}]",ERJ open research,['10.1183/23120541.00275-2019']
2641,32497956,Metacognitions about problematic Smartphone use: Development of a self-report measure.,"BACKGROUND AND AIMS
Recent research has suggested that metacognitions may play a role across the spectrum of addictive behaviours, including problematic use of technological devices. Metacognitions associated with problematic Smartphone use (PSU) have been scarcely investigated and measures to assess these beliefs are not yet available. The goal of the present study was: (i) to develop the first self-report scale of metacognitions about Smartphone use; and (ii) to investigate its predictive validity with respect to PSU.
METHODS
Twenty-four items concerning positive and negative metacognitions about PSU were framed and administered to a community sample of 701 Smartphone users (F = 66.2%; mean age: 28.08 ± 9.81; age range: 15-70). An exploratory factor analysis was first performed in a randomly allocated subsample of 350 participants. A confirmative factor analysis was then computed on a second subsample of 351 participants to test the fit of the factor structure identified.
RESULTS
Findings revealed a 3-factor solution consisting of positive metacognitions concerning emotional and cognitive regulation, positive metacognitions concerning social advantages, and negative metacognitions about uncontrollability and cognitive harm of Smartphone use. Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire (MSUQ) factors were significantly associated to PSU independently of anxiety and depressive symptoms.
CONCLUSIONS
The MSUQ might be a promising self-report measure and further support research into the role of metacognition in technological addictions.",2020,Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire,"['350 participants', 'Twenty-four items concerning positive and negative metacognitions about PSU were framed and administered to a community sample of 701 Smartphone users (F\xa0=\xa066.2%; mean age: 28.08\xa0±\xa09.81; age range: 15-70']",[],"['anxiety and depressive symptoms', 'Metacognitions about Smartphone Use Questionnaire']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",701.0,0.0366231,Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Casale', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy. Electronic address: silvia.casale@unifi.it.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Caponi', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Fioravanti', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106484']
2642,32498040,Reducing Sitting Time in Obese Older Adults: The I-STAND Randomized Controlled Trial.,"BACKGROUND
The authors tested the efficacy of the ""I-STAND"" intervention for reducing sitting time, a novel and potentially health-promoting approach, in older adults with obesity.
METHODS
The authors recruited 60 people (mean age = 68 ± 4.9 years, 68% female, 86% White; mean body mass index = 35.4). The participants were randomized to receive the I-STAND sitting reduction intervention (n = 29) or healthy living control group (n = 31) for 12 weeks. At baseline and at 12 weeks, the participants wore activPAL devices to assess sitting time (primary outcome). Secondary outcomes included fasting glucose, blood pressure, and weight. Linear regression models assessed between-group differences in the outcomes.
RESULTS
The I-STAND participants significantly reduced their sitting time compared with the controls (-58 min per day; 95% confidence interval [-100.3, -15.6]; p = .007). There were no statistically significant changes in the secondary outcomes.
CONCLUSION
I-STAND was efficacious in reducing sitting time, but not in changing health outcomes in older adults with obesity.",2020,"The I-STAND participants significantly reduced their sitting time compared with the controls (-58 min per day; 95% confidence interval [-100.3, -15.6]; p = .007).","['Obese Older Adults', 'older adults with obesity', '60 people (mean age = 68 ± 4.9 years, 68% female, 86% White; mean body mass index = 35.4']","['I-STAND sitting reduction intervention', 'I-STAND"" intervention', 'healthy living control group']","['sitting time', 'fasting glucose, blood pressure, and weight']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.145731,"The I-STAND participants significantly reduced their sitting time compared with the controls (-58 min per day; 95% confidence interval [-100.3, -15.6]; p = .007).","[{'ForeName': 'Dori E', 'Initials': 'DE', 'LastName': 'Rosenberg', 'Affiliation': ''}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Renz', 'Affiliation': ''}, {'ForeName': 'Theresa E', 'Initials': 'TE', 'LastName': 'Matson', 'Affiliation': ''}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Mikael Anne', 'Initials': 'MA', 'LastName': 'Greenwood-Hickman', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Arterburn', 'Affiliation': ''}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gardiner', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': ''}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0470']
2643,32498073,Systematic manipulations of the biological stress systems result in sex-specific compensatory stress responses and negative mood outcomes.,"Women are twice as likely as men to be diagnosed with anxiety and mood disorders. One potential underlying mechanism is sex differences in physiological and psychological responses to stress; however, no studies to date have investigated this proposed mechanism experimentally. In a double-blind, placebo-controlled design, pharmacological challenges were administered to individually suppress the hypothalamic-pituitary-adrenal (HPA) axis, or the sympathetic nervous system (SNS) prior to stress exposure, to investigate sex differences in the resulting cross talk among the physiological and psychological stress responses. Sex-specific compensatory patterns and psychological effects emerged when the stress systems were manipulated. Men demonstrated heightened SNS reactivity to stress when the HPA axis was suppressed, and greater HPA reactivity after SNS suppression. This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects. In women, higher baseline activation (but dampened reactivity to stress) of SNS or HPA was observed when the other system was suppressed. This was coupled with worsened mood in response to stress when either stress system was compromised. Our results indicate that men and women may be differentially sensitive to fluctuations of their stress systems. This might be a potential link that underlies the sexual dimorphism in vulnerability for psychopathology.",2020,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.",[],['placebo'],['HPA reactivity'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0182391,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.","[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada. nida.ali@mail.mcgill.ca.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Cooperman', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Baldwin', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Faculty of Medicine, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0726-8']
2644,32493475,A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
Primary objective: to evaluate the efficacy of melatonin as a prophylactic treatment on prevention of symptomatic SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure. Secondary objectives: To evaluate the efficacy of melatonin as a prophylactic treatment on prevention of asymptomatic SARS-CoV-2 infection.To evaluate the efficacy of melatonin to prevent the development of severe COVID-19 in the participants enrolled in this study who develop SARS-CoV-2 infection along the trial.To evaluate the duration of COVID-19 symptoms in participants receiving melatonin before the infection.To evaluate seroconversion timing post-symptom onset. Exploratory objectives:To compare severity of COVID-19 between men and women.To evaluate the influence of sleep and diet on prevention from SARS-CoV-2 infection.To evaluate the effect of melatonin on the incidence and characteristics of lymphopenia and increase of inflammatory cytokines related to COVID-19.
TRIAL DESIGN
This is a two-arm parallel randomised double-blind controlled trial to evaluate the efficacy of melatonin versus placebo in the prophylaxis of coronavirus disease 2019 among healthcare workers.
PARTICIPANTS
Inclusion Criteria: Male or female participants ≥ 18 and ≤ 80 years of age.Healthcare workers from the public and private Spanish hospital network at risk of SARS-CoV 2 infection.Not having a previous COVID19 diagnosis.Understanding the purpose of the trial and not having taken any pre-exposure prophylaxis (PrEP) including HIV PrEP from March 1 st 2020 until study enrolment.Having a negative SARS-CoV 2 reverse-transcription PCR (RT-PCR) result or a negative serologic rapid test (IgM/IgG) result before randomization.Premenopausal women must have a negative urinary pregnancy test in the 7 days before starting the trial treatment.Premenopausal women and males with premenopausal couples must commit to using a high efficiency anticonceptive method.
EXCLUSION CRITERIA
HIV infection.Active hepatitis B infection.Renal failure (CrCl < 60 mL/min/1.73 m2) or need for hemodialysis.Osteoporosis.Myasthenia gravis.Pre-existent maculopathy.Retinitis pigmentosa.Bradycardia (less than 50 bpm).Weight less than 40 Kg.Participant with any immunosuppressive condition or hematological disease.Treatment with drugs that may prolong QT in the last month before randomization for more than 7 days including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone.Hereditary intolerance to galactose, Lapp lactase deficiency or glucose or galactose malabsorption.Treatment with fluvoxamine.Treatment with benzodiazepines or benzodiazepine analogues such as zolpidem, zopiclone or zaleplon.Pregnancy.Breastfeeding.History of potentially immune derived diseases such as: lupus, Crohn's disease, ulcerative colitis, vasculitis or rheumatoid arthritis.Insulin-dependent diabetes mellitus.Known history of hypersensitivity to the study drug or any of its components.Patients that should not be included in the study at the judgment of the research team. Participants will be recruited from the following eight hospitals in Madrid, Spain: Hospital Universitario La Paz, Hospital Ramón y Cajal, Hospital Infanta Sofía, Hospital 12 de Octubre, Hospital Clínico San Carlos, Hospital Central de la defensa Gómez Ulla,Hospital de La Princesa and Hospital Infanta Leonor.
INTERVENTION AND COMPARATOR
Experimental: Melatonin (Circadin®, Exeltis Healthcare, Spain): 2 mg of melatonin orally before bedtime for 12 weeks. Comparator: Identical looking placebo (Laboratorios Liconsa, Spain) orally before bedtime for 12 weeks.
MAIN OUTCOMES
Number of SARS-CoV-2 (COVID-19) symptomatic infections confirmed by polymerase chain reaction (PCR) test or serologic test or according to each centre diagnosis protocol. Primary outcome will be measured until the end of treatment for each participant (until the date of the last dose taken by each patient).
RANDOMISATION
Patients who meet all inclusion and no exclusion criteria will be randomised, stratified by centres, sex and age (<50 and ≥ 50 years old). The randomisation sequence was created using SAS version 9.4 statistical software (procedure 'PROC PLAN') with a 1:1 allocation. No randomisation seed was specified. The randomisation seed was generated taking the hour of the computer where the program was executed. Randomization will be done centrally through the electronic system RedCAP® in order to conceal the sequence until interventions are assigned BLINDING (MASKING): Participants, caregivers, and those assessing the outcomes are blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
A total of 450 participants are planned to be enrolled in this clinical trial, 225 in the experimental arm and 225 in the placebo arm.
TRIAL STATUS
Protocol version 3.0, 17th of April 2020. Recruitment ongoing. First participant was recruited on the 21st of April 2020. The final participant is anticipated to be recruited on the 31st of May 2020. As of May 18th, 2020, a total of 312 participants have been enrolled (154 at Hospital La Paz, 85 at Hospital Infanta Sofía and 73 at Hospital 12 de Octubre).
TRIAL REGISTRATION
EU Clinical Trials Register: 2020-001530-35; Date of trial registration: 13th of April 2020; https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001530-35/ES FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,To evaluate the efficacy of melatonin to prevent the development of severe COVID-19 in the participants enrolled in this study who develop SARS-CoV-2 infection along the trial.,"['high-risk contacts (MeCOVID Trial', 'Premenopausal women', 'participants enrolled in this study who develop SARS-CoV-2 infection along the trial', 'Inclusion Criteria: Male or female participants ≥ 18 and ≤ 80 years of age', 'Premenopausal women and males with premenopausal couples', 'Participants will be recruited from the following eight hospitals in Madrid, Spain: Hospital Universitario La Paz, Hospital Ramón y Cajal, Hospital Infanta Sofía, Hospital 12 de Octubre, Hospital Clínico San Carlos, Hospital Central de la defensa Gómez Ulla,Hospital de La Princesa and Hospital Infanta Leonor', 'Participant with any immunosuppressive condition or hematological disease', 'Protocol version 3.0, 17th of April 2020', 'Healthcare workers from the public and private Spanish hospital network at risk of SARS-CoV 2 infection', 'men and women', 'Retinitis pigmentosa', 'participants receiving melatonin before the infection', '312 participants have been enrolled (154 at Hospital La Paz, 85 at Hospital Infanta Sofía and 73 at Hospital 12 de Octubre', 'coronavirus disease 2019 among healthcare workers', '450 participants are planned to be enrolled in this clinical trial, 225 in the experimental arm and 225 in the placebo arm', 'healthcare workers at high risk of SARS-CoV-2 exposure', 'Myasthenia gravis']","['azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone', 'fluvoxamine', 'Comparator', 'Identical looking placebo (Laboratorios Liconsa, Spain', 'Melatonin (Circadin®', 'melatonin', 'benzodiazepines or benzodiazepine', 'placebo']","['Bradycardia', 'Number of SARS-CoV-2 (COVID-19) symptomatic infections confirmed by polymerase chain reaction (PCR) test or serologic test or according to each centre diagnosis protocol', 'Renal failure', 'duration of COVID-19 symptoms', 'Insulin-dependent diabetes mellitus']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0445462', 'cui_str': 'Carlos'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035334', 'cui_str': 'Retinitis pigmentosa'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0072916', 'cui_str': 'Cisapride'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0120726', 'cui_str': 'halofantrine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0531104', 'cui_str': 'lumefantrine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0030863', 'cui_str': 'Pentamidine'}, {'cui': 'C0033216', 'cui_str': 'Procainamide'}, {'cui': 'C0034414', 'cui_str': 'Quinidine'}, {'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C0037707', 'cui_str': 'Sotalol'}, {'cui': 'C0052585', 'cui_str': 'sparfloxacin'}, {'cui': 'C0039943', 'cui_str': 'Thioridazine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0085228', 'cui_str': 'Fluvoxamine'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}]",312.0,0.378359,To evaluate the efficacy of melatonin to prevent the development of severe COVID-19 in the participants enrolled in this study who develop SARS-CoV-2 infection along the trial.,"[{'ForeName': 'Irene García', 'Initials': 'IG', 'LastName': 'García', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rodriguez-Rubio', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Amelia Rodríguez', 'Initials': 'AR', 'LastName': 'Mariblanca', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Lucía Martínez', 'Initials': 'LM', 'LastName': 'de Soto', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Lucía Díaz', 'Initials': 'LD', 'LastName': 'García', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Jaime Monserrat', 'Initials': 'JM', 'LastName': 'Villatoro', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Javier Queiruga', 'Initials': 'JQ', 'LastName': 'Parada', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Enrique Seco', 'Initials': 'ES', 'LastName': 'Meseguer', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Rosales', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'González', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Carcas', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Oliva', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain. pedro.oliva@salud.madrid.org.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Borobia', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain. alberto.borobia@salud.madrid.org.'}]",Trials,['10.1186/s13063-020-04436-6']
2645,32493478,Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
Primary Objective • To test the efficacy of Hydroxychloroquine (HCQ) (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection Secondary objectives • To determine the safety and tolerability of HCQ as SARS-CoV-2 Post-exposure Prophylaxis (PEP) in adults • To test the efficacy of HCQ (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection 2 weeks after completing therapy, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection • To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group • To test the efficacy of HCQ to prevent incident COVID-19 TRIAL DESIGN: This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of HCQ PEP for the prevention of SARS-CoV-2 infection in adults exposed to the virus.
PARTICIPANTS
This study will enroll up to 2000 asymptomatic adults 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. This multisite trial will be conducted at seven sites in Seattle (UW), Los Angeles (UCLA), New Orleans (Tulane), Baltimore (UMB), New York City (NYU), Syracuse (SUNY-Upstate), and Boston (BMC). Inclusion criteria Participants are eligible to be included in the study only if all of the following criteria apply: 1.Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent2.Willing and able to provide informed consent3.Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or index who is currently being assessed for COVID-19 Close contact is defined as: a.Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis or prolonged exposure within a residence/vehicle/enclosed space without maintaining social distance)b.Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)4.Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case5.Access to device and internet for Telehealth visits6.Not planning to take HCQ in addition to the study medication Exclusion criteria Participants are excluded from the study if any of the following criteria apply: 1.Known hypersensitivity to HCQ or other 4-aminoquinoline compounds2.Currently hospitalized3.Symptomatic with subjective fever, cough, or shortness of breath4.Current medications exclude concomitant use of HCQ5.Concomitant use of other anti-malarial treatment or chemoprophylaxis, including chloroquine, mefloquine, artemether, or lumefantrine.6.History of retinopathy of any etiology7.Psoriasis8.Porphyria9.Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100 K)10.Concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen11.Known moderate or severe liver disease12.Known long QT syndrome13.Severe renal impairment14.Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs or planned use during the study period INTERVENTION AND COMPARATOR: Households will be randomized 1:1 (at the level of household), with close contact participants receiving one of the following therapies: •HCQ 400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days •Placebo-like control (ascorbic acid) 500 mg orally daily for 3 days then 250 mg orally daily for 11 days MAIN OUTCOMES: The primary outcome of the study is the incidence of SARS-CoV-2 infection through day 14 among participants who are SARS-CoV-2 negative at baseline by randomization group.
RANDOMISATION
Participants will be randomized in a 1:1 ratio to HCQ or ascorbic acid at the level of the household (all eligible participants in 1 household will receive the same intervention). The randomization code and resulting allocation list will be generated and maintained by the Study Statistician. The list will be blocked and stratified by site and contact type (household versus healthcare worker).
BLINDING (MASKING)
This is a blinded study. HCQ and ascorbic acid will appear similar, and taste will be partially masked as HCQ can be bitter and ascorbic acid will be sour. The participants will be blinded to their randomization group once assigned. Study team members, apart from the Study Pharmacist and the unblinded statistical staff, will be blinded. Laboratory staff are blinded to the group allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
The sample size for the study is N=2 000 participants randomized 1:1 to either HCZ (n=1 000) and ascorbic acid (n=1 000).
TRIAL STATUS
Protocol version: 1.2 05 April 2020 Recruitment is ongoing, started March 31 and anticipated end date is September 30, 2020.
TRIAL REGISTRATION
ClinicalTrials.gov, Protocol Registry Number: NCT04328961 Date of registration: April 1, 2020, retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group •,"['2000 asymptomatic adults 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test', 'Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)4.Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection', 'adults •', 'Protocol version: 1.2 05 April 2020', '1.Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent2.Willing and able to provide informed consent3.Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or index who is currently being assessed for COVID-19 Close contact is defined as: a', 'of retinopathy of any etiology7.Psoriasis8.Porphyria9.Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100 K)10.Concomitant use of', 'adults exposed to the virus', 'severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19', 'Inclusion criteria Participants are eligible to be included in the study only if all of the following criteria apply']","['placebo-equivalent (ascorbic acid', 'HCZ', 'hydroxychloroquine', 'chloroquine, mefloquine, artemether, or lumefantrine.6.History', 'HCQ', 'HCQ as SARS-CoV-2 Post-exposure Prophylaxis (PEP', '•HCQ 400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days •Placebo-like control (ascorbic acid', 'digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen11.Known moderate or severe liver disease12.Known long QT syndrome13.Severe renal impairment14.Use of any investigational or non-registered drug or vaccine', 'HCQ or ascorbic acid', 'HCQ PEP', 'HCQ and ascorbic acid', 'Hydroxychloroquine (HCQ', 'ascorbic acid']","['incidence of SARS-CoV-2 infection', 'safety and tolerability']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0052429', 'cui_str': 'artemether'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0008783', 'cui_str': 'Cimetidine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1.0,0.289709,To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group •,"[{'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA. rbarnaba@uw.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bershteyn', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': 'Bill and Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wener', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wesche', 'Affiliation': 'Certara, Princeton, NJ, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04446-4']
2646,32493494,"Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial.","BACKGROUND
SARS-CoV-2 infection presents a high transmission in the group of health professionals in Spain (12-15% infected). Currently there is no accepted chemoprophylaxis but hydroxychloroquine (HDQ) is known to inhibit the coronavirus in vitro. Our hypothesis is that oral administration of hydroxychloroquine to healthcare professionals can reduce the incidence and prevalence of infection as well as its severity in this group.
METHODS
Design: Prospective, single center, double blind, randomised, controlled trial (RCT).
PARTICIPANTS
Adult health-care professionals (18-65 years) working in areas of high exposure and high risk of transmission of SARS-COV-2 (COVID areas, Intensive Care Unit -ICUs-, Emergency, Anesthesia and all those performing aerosol-generating procedures) will be included. Exclusion criteria include previous infection with SARS CoV2 (positive SARS-CoV-2 PCR or IgG serology), pregnancy or lactation, any contraindication to hydroxychloroquine or evidence of unstable or clinically significant systemic disease.
INTERVENTIONS
Patients will be randomized (1:1) to receive once-daily oral Hydroxychloroquine 200mg for two months (HC group) or placebo (P group) in addition to the protective measures appropriate to the level of exposure established by the hospital. A serological evaluation will be carried out every 15 days with PCR in case of seroconversion, symptoms or risk exposure. Primary outcome is the percentage of subjects presenting infection (seroconversion and/or PCR +ve) by the SARS-Cov-2 virus during the observation period. Additionally, both the percentage of subjects in each group presenting Pneumonia with severity criteria (Curb 65 ≥2) and that of subjects requiring admission to ICU will be determined.
DISCUSSION
While awaiting a vaccine, hygiene measures, social distancing and personal protective equipment are the only primary prophylaxis measures against SARS-CoV-2, but they have not been sufficient to protect our healthcare professionals. Some evidence of the in vitro efficacy of hydroxychloroquine against this virus is known, along with some clinical data that would support the study of this drug in the chemoprophylaxis of infection. However, there are still no data from controlled clinical trials in this regard. If our hypothesis is confirmed, hydroxychloroquine can help professionals fight this infection with more guarantees.
PARTICIPANTS
This is a single-center study that will be carried out at the Marqués de Valdecilla University Hospital. 450 health professionals working at the Hospital Universitario Marqués de Valdecilla in areas of high exposure and high risk of transmission of SARS COV2 (COVID hospital areas, Intensive Care Unit, Emergency, Anesthesia and all those performing aerosol-generating procedures) will be included.
INCLUSION CRITERIA
1) Health professionals aged between 18 and 65 years (inclusive) at the time of the first screening visit; 2) They must provide signed written informed consent and agree to comply with the study protocol; 3) Active work in high exposure areas during the last two weeks and during the following weeks.
EXCLUSION CRITERIA
1) Previous infection with SARS CoV2 (positive coronavirus PCR or positive serology with SARS Cov2 negative PCR and absence of symptoms); 2) Current treatment with hydroxychloroquine or chloroquine; 3) Hypersensitivity, allergy or any contraindication for taking hydroxychloroquine, in the technical sheet; 4) Previous or current treatment with tamoxifen or raloxifene; 5) Previous eye disease, especially maculopathy; 6) Known heart failure (Grade III to IV of the New York Heart Association classification) or prolonged QTc; 7) Any type of cancer (except basal cell) in the last 5 years; 6) Refusal to give informed consent; 8) Evidence of any other unstable or clinically significant untreated immune, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric illness; 9) Antibodies positive for the human immunodeficiency virus; 10) Significant kidney or liver disease; 11) Pregnancy or lactation.
INTERVENTION AND COMPARATOR
Two groups will be analyzed with a 1: 1 randomization rate. 1)Intervention: (n = 225): One 200 mg hydroxychloroquine sulfate coated tablet once daily for two months.2)Comparator (control group) (n = 225): One hydroxychloroquine placebo tablet (identical to that of the drug) once daily for two months MAIN OUTCOMES: The primary outcome of this study will be to evaluate: number and percentage of healthcare personnel presenting symptomatic and asymptomatic infection (see ""Diagnosis of SARS CoV2 infection"" below) by the SARS-Cov2 virus during the study observation period (8 weeks) in both treatment arms;number and percentage of healthcare personnel in each group presenting with Pneumonia with severity criteria (Curb 65 ≥2) and number and percentage of healthcare personnel requiring admission to the Intensive Care Unit (ICU) in both treatment arms. DIAGNOSIS OF SARS COV2 INFECTION: Determination of IgA, IgM and IgG type antibodies against SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA kit (EUROIMMUN Medizinische Labordiagnostika AG, Germany) every two weeks. In cases of seroconversion, a SARS-CoV-2 PCR will be performed to rule out / confirm an active infection (RT-PCR in One Step: RT performed with mastermix (Takara) and IDT probes, following protocol published and validated by the CDC Evaluation of COVID-19 in case of SARS-CoV-2 infection RANDOMISATION: Participants will be allocated to intervention and comparator groups according to a balanced randomization scheme (1: 1). The assignment will be made through a computer-generated numeric sequence for all participants BLINDING (MASKING): Both participants and investigators responsible for recruiting and monitoring participants will be blind to the assigned arm.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Taking into account the current high prevalence of infection in healthcare personnel in Spain (up to 15%), to detect a difference equal to or greater than 8% in the percentage estimates through a two-tailed 95% CI, with a statistical power of 80% and a dropout rate of 5%, a total of 450 participants will need to be included (250 in each arm).
TRIAL STATUS
The protocol approved by the health authorities in Spain (Spanish Agency for Medicines and Health Products ""AEMPS"") and the Ethics and Research Committee of Cantabria (CEIm Cantabria) corresponds to version 1.1 of April 2, 2020. Currently, recruitment has not yet started, with the start scheduled for the second week of May 2020.
TRIAL REGISTRATION
Eudra CT number: 2020-001704-42 (Registered on 29 March 2020) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Previous infection with SARS CoV2 (positive coronavirus PCR or positive serology with SARS Cov2 negative PCR and absence of symptoms); 2) Current treatment with hydroxychloroquine or chloroquine; 3) Hypersensitivity, allergy or any contraindication for taking hydroxychloroquine, in the technical sheet; 4) Previous or current treatment with tamoxifen or raloxifene; 5) Previous eye disease, especially maculopathy; 6) Known heart failure (Grade III to IV of the New York Heart Association classification) or prolonged QTc; 7) Any type of cancer (except basal cell) in the last 5 years; 6) Refusal to give informed consent; 8) Evidence of any other unstable or clinically significant untreated immune, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric illness; 9) Antibodies positive for the human immunodeficiency virus; 10) Significant kidney or liver disease; 11) Pregnancy or lactation.
","['450 health professionals working at the Hospital Universitario Marqués de Valdecilla in areas of high exposure', 'Eudra CT number: 2020-001704-42 (Registered on 29 March 2020', '1)Intervention: (n = 225', 'Adult health-care professionals (18-65 years) working in areas of high exposure and high risk of transmission of SARS-COV-2 (COVID areas, Intensive Care Unit -ICUs-, Emergency, Anesthesia and all those performing aerosol-generating procedures', 'Health professionals aged between 18 and 65 years (inclusive) at the time of the first screening visit; 2', 'healthcare personnel in the hospital setting']","['hydroxychloroquine chemoprophylaxis', 'hydroxychloroquine placebo', 'Hydroxychloroquine 200mg for two months (HC group) or placebo', 'hydroxychloroquine or chloroquine', 'hydroxychloroquine', 'hydroxychloroquine (HDQ', 'hydroxychloroquine sulfate', 'tamoxifen or raloxifene']","[' number and percentage of healthcare personnel presenting symptomatic and asymptomatic infection (see ""Diagnosis of SARS CoV2 infection"" below', 'efficacy and safety', 'number and percentage of healthcare personnel requiring admission to the Intensive Care Unit (ICU', 'Determination of IgA, IgM and IgG type antibodies against SARS-CoV-2', 'percentage of subjects presenting infection (seroconversion and/or PCR +ve) by the SARS-Cov-2 virus']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C1171177', 'cui_str': 'Adult care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine sulfate'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0275522', 'cui_str': 'Subclinical infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]",450.0,0.193721,"Previous infection with SARS CoV2 (positive coronavirus PCR or positive serology with SARS Cov2 negative PCR and absence of symptoms); 2) Current treatment with hydroxychloroquine or chloroquine; 3) Hypersensitivity, allergy or any contraindication for taking hydroxychloroquine, in the technical sheet; 4) Previous or current treatment with tamoxifen or raloxifene; 5) Previous eye disease, especially maculopathy; 6) Known heart failure (Grade III to IV of the New York Heart Association classification) or prolonged QTc; 7) Any type of cancer (except basal cell) in the last 5 years; 6) Refusal to give informed consent; 8) Evidence of any other unstable or clinically significant untreated immune, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric illness; 9) Antibodies positive for the human immunodeficiency virus; 10) Significant kidney or liver disease; 11) Pregnancy or lactation.
","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cuadrado-Lavín', 'Affiliation': 'Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Av. Valdecilla, 25, 39008, Santander, Cantabria, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Olmos', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Cifrian', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gimenez', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Gandarillas', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'García-Saiz', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Maria Henar', 'Initials': 'MH', 'LastName': 'Rebollo', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Martínez-Taboada', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'López-Hoyos', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'Fariñas', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Crespo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Av. Valdecilla, 25, 39008, Santander, Cantabria, Spain. javiercrespo1991@gmail.com.'}]",Trials,['10.1186/s13063-020-04400-4']
2647,32493500,The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial.,"BACKGROUND
Dentin hypersensitivity (DH) is a condition characterized by short and sharp episodes of pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms cause discomfort in patients and reduce their quality of life. Recently, the novel zinc-containing desensitizer CAREDYNE Shield has been developed as a new type of desensitizer that acts by inducing chemical occlusion of dentinal tubules, and releasing zinc ion for root caries prevention. However, the clinical effectiveness of CAREDYNE Shield on DH remains unclear. Therefore, the aim of this study is to evaluate the effectiveness of CAREDYNE Shield on DH by comparing with that of another desensitizer, Nanoseal, commonly used in Japan.
METHODS/DESIGN
This study protocol is a two-arm, parallel, pilot randomized controlled trial. Forty DH patients will be randomly allocated to two groups. Participants in the intervention group will be treated with CAREDYNE Shield, while those in the control group will be treated with Nanoseal. The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses.
DISCUSSION
CAREDYNE Shield can be casually applied to subgingival areas and proximal surfaces because it reacts with only tooth substance. Furthermore, zinc has been reported to reduce the demineralization of enamel and dentin and inhibit biofilm formation, plaque growth and dentin-collagen degradation. Therefore, CAREDYNE Shield may be expected to be a useful novel desensitizer that acts not only as a desensitizer but also as a root caries inhibitor.
TRIAL REGISTRATION
UMIN Clinical Trials Registry (UMIN-CTR), ID: UMIN000038072. Registered on 21 September 2019.
TRIAL STATUS
This study (protocol version number: version 1.4.0; approved on 22 October 2019) is ongoing. The recruitment of participants began in December 2019 and will be continued until November 2020 (Hanke, Am Dent Assoc 27:1379-1393, 1940).",2020,"The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses.
","['Japan', 'Forty DH patients']",['novel zinc-containing desensitizer'],"['quality of life', 'dentin hypersensitivity', 'reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0917467,"The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses.
","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan. matsuurat@nagasaki-u.ac.jp.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Mae', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohira', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Nakazono', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Kajiro', 'Initials': 'K', 'LastName': 'Yanagiguchi', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}]",Trials,['10.1186/s13063-020-04426-8']
2648,32498269,"Effects of Porphyra tenera Supplementation on the Immune System: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial.","OBJECTIVE
The purpose of this study was to determine if Porphyra tenera extract (PTE) has immune-enhancing effects and is safe in healthy adults.
METHODS
Subjects who met the inclusion criteria (3 × 10 3 ≤ peripheral blood leukocyte level ≥ 8 × 10 3 cells/µL) were recruited for this study. Enrolled subjects ( n = 120) were randomly assigned to either the PTE group ( n = 60) and were given 2.5 g/day of PTE (as PTE) in capsule form or the placebo group ( n = 60) and were given crystal cellulose capsules with the identical appearance, weight, and flavor as the PTE capsules for 8 weeks. Outcomes were assessed based on measuring natural killer (NK) cell activity, cytokines level, and upper respiratory infection (URI), and safety parameters were assessed at baseline and 8 weeks.
RESULTS
Compared with baseline, NK cell activity (%) increased for all effector cell-to-target cell ratios in the PTE group after 8 weeks; however, changes were not observed in the placebo group ( p < 0.10). Subgroup analysis of 101 subjects without URI showed that NK cell activity in the PTE group tended to increase for all effector cell/target cell (E:T) ratios (E:T = 12.5:1 p = 0.068; E:T = 25:1 p = 0.036; E:T = 50:1 p = 0.081) compared with the placebo group. A significant difference between the two groups was observed for the E:T = 25:1 ratio, which increased from 20.3 ± 12.0% at baseline to 23.2 ± 12.4% after 8 weeks in the PTE group ( p = 0.036). A significant difference was not observed in cytokine between the two groups.
CONCLUSION
PTE supplementation appears to enhance immune function by improving NK cell activity without adverse effects in healthy adults.",2020,"Compared with baseline, NK cell activity (%) increased for all effector cell-to-target cell ratios in the PTE group after 8 weeks; however, changes were not observed in the placebo group ( p < 0.10).","['Enrolled subjects ( n = 120', 'Subjects who met the inclusion criteria (3 × 10 3 ≤ peripheral blood leukocyte level ≥ 8 × 10 3 cells/µL', 'healthy adults']","['PTE supplementation', 'Placebo', 'PTE', 'PTE (as PTE) in capsule form or the placebo', 'crystal cellulose capsules with the identical appearance, weight, and flavor as the PTE capsules', 'Porphyra tenera Supplementation', 'Porphyra tenera extract (PTE', 'placebo']","['natural killer (NK) cell activity, cytokines level, and upper respiratory infection (URI), and safety parameters', 'effector cell/target cell (E:T) ratios (E:T', 'cytokine', 'effector cell-to-target cell ratios', 'NK cell activity']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0996258', 'cui_str': 'Porphyra'}, {'cui': 'C4283088', 'cui_str': 'Porphyra tenera extract'}]","[{'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0312740', 'cui_str': 'Immune effector cell'}, {'cui': 'C0221284', 'cui_str': 'Leptocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",120.0,0.381579,"Compared with baseline, NK cell activity (%) increased for all effector cell-to-target cell ratios in the PTE group after 8 weeks; however, changes were not observed in the placebo group ( p < 0.10).","[{'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju 54907, Korea.'}, {'ForeName': 'Hui-Yeon', 'Initials': 'HY', 'LastName': 'Jang', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju 54907, Korea.'}, {'ForeName': 'Eun-Soo', 'Initials': 'ES', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju 54907, Korea.'}, {'ForeName': 'Soon-Ok', 'Initials': 'SO', 'LastName': 'Noh', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju 54907, Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Shin', 'Affiliation': 'Department of Medical Nutrition Therapy, Jeonbuk National University, Jeonju 54896, Korea.'}, {'ForeName': 'Ki-Chan', 'Initials': 'KC', 'LastName': 'Ha', 'Affiliation': 'Healthcare Claims & Management Incorporation, Jeonju 54858, Korea.'}, {'ForeName': 'Hyang-Im', 'Initials': 'HI', 'LastName': 'Baek', 'Affiliation': 'Healthcare Claims & Management Incorporation, Jeonju 54858, Korea.'}, {'ForeName': 'Byung-Jae', 'Initials': 'BJ', 'LastName': 'Ahn', 'Affiliation': 'Marine Biotechnology Research Center, Jeonnam Bioindustry Foundation, Wando 59108, Korea.'}, {'ForeName': 'Tae-Hwan', 'Initials': 'TH', 'LastName': 'Oh', 'Affiliation': 'Marine Biotechnology Research Center, Jeonnam Bioindustry Foundation, Wando 59108, Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju 54907, Korea.'}]",Nutrients,['10.3390/nu12061642']
2649,32498328,The Effect of Low-Carbohydrate Diet on Macrovascular and Microvascular Endothelial Function is Not Affected by the Provision of Caloric Restriction in Women with Obesity: A Randomized Study.,"Obesity impairs both macro- and microvascular endothelial function due to decreased bioavailability of nitric oxide. Current evidence on the effect of low-carbohydrate (LC) diet on endothelial function is conflicting and confounded by the provision of caloric restriction (CR). We tested the hypothesis that LC without CR diet, but not LC with CR diet, would improve macro- and microvascular endothelial function in women with obesity. Twenty-one healthy women with obesity (age: 33 ± 2 years, body mass index: 33.0 ± 0.6 kg/m 2 ; mean ± SEM) were randomly assigned to receive either a LC diet (~10% carbohydrate calories) with CR ( n = 12; 500 calorie/day deficit) or a LC diet without CR ( n = 9) and completed the 6-week diet intervention. After the intervention, macrovascular endothelial function, measured as brachial artery flow-mediated dilation did not change (7.3 ± 0.9% to 8.0 ± 1.1%, p = 0.7). On the other hand, following the LC diet intervention, regardless of CR, blocking nitric oxide production decreased microvascular endothelial function, measured by arteriolar flow-induced dilation ( p ≤ 0.02 for both diets) and the magnitude was more than baseline ( p ≤ 0.04). These data suggest improved NO contributions following the intervention. In conclusion, a 6-week LC diet, regardless of CR, may improve microvascular, but not macrovascular endothelial function, via increasing bioavailability of nitric oxide in women with obesity.",2020,"After the intervention, macrovascular endothelial function, measured as brachial artery flow-mediated dilation did not change (7.3 ± 0.9% to 8.0 ± 1.1%, p = 0.7).","['women with obesity', 'Women with Obesity', 'Twenty-one healthy women with obesity (age: 33 ± 2 years, body mass index: 33.0 ± 0.6 kg/m 2 ; mean ± SEM']","['LC diet without CR ( n = 9) and completed the 6-week diet intervention', 'LC with CR diet', 'Low-Carbohydrate Diet', 'low-carbohydrate (LC) diet', 'LC diet (~10% carbohydrate calories) with CR']","['brachial artery flow-mediated dilation', 'microvascular endothelial function', 'Macrovascular and Microvascular Endothelial Function', 'macro- and microvascular endothelial function', 'macrovascular endothelial function', 'arteriolar flow-induced dilation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",21.0,0.0299143,"After the intervention, macrovascular endothelial function, measured as brachial artery flow-mediated dilation did not change (7.3 ± 0.9% to 8.0 ± 1.1%, p = 0.7).","[{'ForeName': 'Chueh-Lung', 'Initials': 'CL', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ranieri', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Szczurek', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Assem M', 'Initials': 'AM', 'LastName': 'Ellythy', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elokda', 'Affiliation': 'Department of Rehabilitation Sciences, Florida Gulf Coast University, Fort Myers, FL 33965, USA.'}, {'ForeName': 'Abeer M', 'Initials': 'AM', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Nutrients,['10.3390/nu12061649']
2650,32498372,"A Double-Blind, Randomized Placebo-Controlled Trial of Probiotic Lactobacillus casei Shirota in Stable Cirrhotic Patients.","Background : In cirrhosis, a pathological gut microbiome has been linked with immune dysfunction. A pilot study of probiotic Lactobacillus casei Shirota (LcS) in alcoholic cirrhosis demonstrated significant improvement in neutrophil function. This study aimed to evaluate the efficacy of LcS on neutrophil function and significant infection rates in patients with cirrhosis. Methods : 92 cirrhotic patients (Child-Pugh score ≤10) were randomized to receive LcS or placebo, three times daily for six months. Primary end-points were incidence of significant infection and neutrophil function. Secondary end-points were cytokine profile, endotoxin, bacterial DNA positivity, intestinal permeability and quality of life. Results : Rates of infection, decompensation or neutrophil function did not differ between placebo and probiotic groups. LcS significantly reduced plasma monocyte chemotactic protein-1 and, on subgroup analysis, plasma interleukin-1β (alcoholic cirrhosis), interleukin-17a and macrophage inflammatory protein-1β (non-alcoholic cirrhosis), compared with placebo. No significant differences in intestinal permeability, bacterial translocation or metabolomic profile were observed. Conclusion : LcS supplementation in patients with early cirrhosis is safe. Although no significant infections were observed in either group, LcS improved cytokine profile towards an anti-inflammatory phenotype, an effect which appears to be independent of bacterial translocation.",2020,"LcS significantly reduced plasma monocyte chemotactic protein-1 and, on subgroup analysis, plasma interleukin-1β (alcoholic cirrhosis), interleukin-17a and macrophage inflammatory protein-1β (non-alcoholic cirrhosis), compared with placebo.","['Pugh score ≤10', 'Stable Cirrhotic Patients', 'patients with cirrhosis', '92 cirrhotic patients (Child', 'patients with early cirrhosis is safe']","['Placebo', 'LcS supplementation', 'LcS or placebo', 'Probiotic Lactobacillus casei Shirota', 'probiotic Lactobacillus casei Shirota (LcS', 'LcS', 'placebo']","['incidence of significant infection and neutrophil function', 'neutrophil function', 'neutrophil function and significant infection rates', 'cytokine profile, endotoxin, bacterial DNA positivity, intestinal permeability and quality of life', 'subgroup analysis, plasma interleukin-1β (alcoholic cirrhosis), interleukin-17a and macrophage inflammatory protein-1β (non-alcoholic cirrhosis', 'intestinal permeability, bacterial translocation or metabolomic profile', 'plasma monocyte chemotactic protein-1', 'Rates of infection, decompensation or neutrophil function']","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299579', 'cui_str': 'Early cirrhosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0268314', 'cui_str': 'Cholestasis-edema syndrome, Norwegian type'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0012924', 'cui_str': 'Bacterial DNA'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0023891', 'cui_str': 'Alcoholic cirrhosis'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0400943', 'cui_str': 'Cirrhosis - non-alcoholic'}, {'cui': 'C0282583', 'cui_str': 'Bacterial translocation'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}]",92.0,0.471678,"LcS significantly reduced plasma monocyte chemotactic protein-1 and, on subgroup analysis, plasma interleukin-1β (alcoholic cirrhosis), interleukin-17a and macrophage inflammatory protein-1β (non-alcoholic cirrhosis), compared with placebo.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Macnaughtan', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Figorilli', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'García-López', 'Affiliation': 'Data Management Centre, European Foundation for the Study of Chronic Liver Failure (EF-CLIF), 08021 Barcelona, Spain.'}, {'ForeName': 'Haw', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jones', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Sawhney', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Yakult Europe B.V., 1332 EN Almere, The Netherlands.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fairclough', 'Affiliation': 'Mid and South Essex NHS Foundation Trust, Basildon & Thurrock University Hospitals NHS Foundation Trust, Basildon, SS16 5NL, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': ""Department of Biochemistry, Bessemer Wing, King's College Hospital, London SE5 9RS, UK.""}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Moratella', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}, {'ForeName': 'I Jane', 'Initials': 'IJ', 'LastName': 'Cox', 'Affiliation': 'Institute of Hepatology London, Foundation for Liver Research, London SE5 9NT, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Yakult Europe B.V., 1332 EN Almere, The Netherlands.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Davies', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Institute of Hepatology London, Foundation for Liver Research, London SE5 9NT, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Mookerjee', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Wright', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Jalan', 'Affiliation': 'UCL Institute for Liver and Digestive Health, Division of Medicine, University College London, London NW3 2PF, UK.'}]",Nutrients,['10.3390/nu12061651']
2651,32498373,High-Intensity Training Reduces CVD Risk Factors among Rotating Shift Workers: An Eight-Week Intervention in Industry.,"Rotating shift work is associated with risk factors for cardiovascular disease (CVD). We have studied the effect of 17 min high-intensity training three times a week over eight weeks on CVD risk factors among shift workers. Sixty-five shift workers from two plants were recruited. They were all deemed healthy at the initial health screening and in 100% work. From plant A, 42 workers, and plant B, 23 workers participated. After the intervention, 56 workers were retested. The intervention group consisted of 19 participants from plant A who had participated in at least 10 sessions. Twenty workers from plant B and 17 workers from plant A that not had taken part in the training were included in the control group. All workers reported physical activity (PA) by questionnaires before and after the training intervention. We measured blood pressure, heart rate, lipids, glycated hemoglobin (HbA1c), and C-reactive protein (CRP) and arterial stiffness. Maximal oxygen uptake (V̇O 2max ) was assessed by bicycle ergometry. The intervention group favorably differed significantly from the control group in improvement of systolic and diastolic blood pressure and glycated hemoglobin (HbA1c). Short training sessions with 4 min of high-intensity PA, three times a week, for eight weeks among rotating shift workers reduced some CVD risk factors. PA interventions in occupational settings may thus decrease coronary heart disease and stroke incidences in this vulnerable group of workers.",2020,The intervention group favorably differed significantly from the control group in improvement of systolic and diastolic blood pressure and glycated hemoglobin (HbA1c).,"['Rotating Shift Workers', '19 participants from plant A who had participated in at least 10 sessions', 'Sixty-five shift workers from two plants were recruited', 'From plant A, 42 workers, and plant B, 23 workers participated', 'Twenty workers from plant B and 17 workers from plant A that not had taken part in the training were included in the control group']","['High-Intensity Training', 'PA interventions']","['CVD Risk Factors', 'Maximal oxygen uptake (V̇O 2max ', 'CVD risk factors', 'blood pressure, heart rate, lipids, glycated hemoglobin (HbA1c), and C-reactive protein (CRP) and arterial stiffness', 'coronary heart disease and stroke incidences', 'physical activity (PA', 'systolic and diastolic blood pressure and glycated hemoglobin (HbA1c']","[{'cui': 'C0555009', 'cui_str': 'Rotating shift worker'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",19.0,0.0220527,The intervention group favorably differed significantly from the control group in improvement of systolic and diastolic blood pressure and glycated hemoglobin (HbA1c).,"[{'ForeName': 'Asgeir', 'Initials': 'A', 'LastName': 'Mamen', 'Affiliation': 'School of Health Sciences, Kristiania University College, Box 1190, Sentrum, 0107 Oslo, Norway.'}, {'ForeName': 'Reidun', 'Initials': 'R', 'LastName': 'Øvstebø', 'Affiliation': 'The Blood Cell Research Group, Department of Medical Biochemistry, Oslo University Hospital, 0450 Ullevaal, Norway.'}, {'ForeName': 'Per Anton', 'Initials': 'PA', 'LastName': 'Sirnes', 'Affiliation': 'Østlandske Hjertesenter, 1523 Moss, Norway.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nielsen', 'Affiliation': 'Ringvoll BHT, 1523 Moss, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Skogstad', 'Affiliation': 'Ringvoll BHT, 1523 Moss, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17113943']
2652,32499263,"Monitoring patients with acute dyspnoea with a serial focused ultrasound of the heart and the lungs (MODUS): a protocol for a multicentre, randomised, open-label, pragmatic and controlled trial.","INTRODUCTION
Among patients admitted to an emergency department, dyspnoea is one of the most common symptoms. Patients with dyspnoea have high mortality and morbidity. Therefore, novel methods to monitor the patients are warranted. The aim is to investigate whether therapy guided by monitoring patients with acute dyspnoea with serial ultrasound examinations of the heart and the lungs together with standard care can change the severity of dyspnoea compared with treatment guided by standard monitoring alone.
METHODS AND ANALYSIS
The study will be conducted as a multicentre, randomised, pragmatic, open-label and controlled trial where patients admitted with acute dyspnoea to an emergency ward will be randomised into a standard care group and a serial ultrasound group with 103 patients in each. All patients will be examined with an ultrasound of the heart and the lungs upfront. In addition, the patients in the serial ultrasound group will be examined with an ultrasound of the heart and lungs two more times to guide further therapy during the admittance. The primary outcome is a change in dyspnoea on a verbal scale. After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
ETHICS AND DISSEMINATION
The trial is conducted in accordance with the Declaration of Helsinki and approved by The Regional Committee on Health Research Ethics for Region Zealand, Denmark (identifier SJ-744). Data handling agreement with participating centres has been made (identifier REG-056-2019). The General Data Protection Regulation and the Danish Data Protection Act will be respected. The results of the trial will be reported in peer-reviewed scientific journals regardless of the outcomes.
TRIAL REGISTRATION NUMBER
NCT04091334.",2020,"After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
","['Monitoring patients with acute dyspnoea with a serial focused ultrasound of the heart and the lungs (MODUS', 'Patients with dyspnoea have high mortality and morbidity', 'patients admitted with acute dyspnoea to an emergency ward will be randomised into a standard care group and a serial ultrasound group with 103 patients in each', 'patients with acute dyspnoea with serial ultrasound examinations of the heart and the lungs together with standard care']",[],"['change in dyspnoea on a verbal scale', 'number of readmissions, death and length of hospital stay']","[{'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0743323', 'cui_str': 'Acute dyspnea'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1449955', 'cui_str': 'Modus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0722347,"After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Arvig', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark doktorarvig@gmail.com.'}, {'ForeName': 'Annmarie T', 'Initials': 'AT', 'LastName': 'Lassen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gæde', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christian B', 'Initials': 'CB', 'LastName': 'Laursen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034373']
2653,32499552,"Subjective versus objective, polymer bur-based selective carious tissue removal: 1-year interim analysis of a randomized clinical trial.","We aimed to compare subjective (S) vs. objective (O) selective carious tissue removal using hand-excavation versus a self-limiting polymer bur, respectively. A community-based single-blind cluster-randomized controlled superiority trial was performed. This is a 1-year-interim analysis. 115 children (age 7-8 years) with ≥1 vital primary molar with a deep dentin lesion (>1/2 dentin depth) were included (60 S/55 O). The cluster was the child, with eligible molars being treated identically (91 S/86 O). Cavities were prepared and carious tissue on pulpo-proximal walls selectively removed using hand instruments (S), or a self-limiting polymer bur (Polybur P1, Komet). Cavities were restored using glass-hybrid material (Equia Forte, GC). Treatment times and children's satisfaction were recorded. Generalized-linear models (GLM) and multi-level Cox-regression analysis were applied. Initial treatment times were not significantly different between protocols (mean; 95%CI S: 433; 404-462 sec; O: 412; 382-441 sec; p = 0.378/GLM). There was no significant difference in patients' satisfaction (p = 0.164). No pulpal exposures occurred. 113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%). Pulpal complications occurred in 5(6%) O and 2(2.2%) S molars, respectively. Risk of failure was not significantly associated with the removal protocol, age, sex, dental arch or tooth type (p > 0.05/Cox), but was nearly 5-times higher in multi-surface than single-surface restorations (HR: 4.60; 95% CI: 1.70-12.4). Within the limitations of this interim analysis, there was no significant difference in treatment time, satisfaction and risk of failure between O and S.",2020,113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%).,"['113 children', '115 children (age 7-8 years) with ≥1 vital primary molar with a deep dentin lesion (>1/2 dentin depth) were included (60\u2009S/55\u2009O']",['polymer bur-based selective carious tissue removal'],"[""Treatment times and children's satisfaction"", ""patients' satisfaction"", 'Risk of failure', 'Pulpal complications', 'treatment time, satisfaction and risk of failure between O and S']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",115.0,0.0819157,113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%).,"[{'ForeName': 'Marta Gomes', 'Initials': 'MG', 'LastName': 'Marques', 'Affiliation': 'Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Leandro Augusto', 'Initials': 'LA', 'LastName': 'Hilgert', 'Affiliation': 'Department of Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Larissa Ribeiro', 'Initials': 'LR', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Karine Medeiros', 'Initials': 'KM', 'LastName': 'Demarchi', 'Affiliation': 'Graduate Program in Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Patrícia Magno', 'Initials': 'PM', 'LastName': 'Dos Santos Matias', 'Affiliation': 'Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Ana Paula Dias', 'Initials': 'APD', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Restorative Dental Sciences, University of Florida College of Dentistry, Gainesville, Florida, USA.'}, {'ForeName': 'Soraya Coelho', 'Initials': 'SC', 'LastName': 'Leal', 'Affiliation': 'Department of Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Paris', 'Affiliation': 'Department of Oral Diagnostics, Digital Health, Health Services Research, Charité- Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Department of Oral Diagnostics, Digital Health, Health Services Research, Charité- Universitätsmedizin, Berlin, Germany. falk.schwendicke@charite.de.'}]",Scientific reports,['10.1038/s41598-020-66074-x']
2654,32499686,Peripheral Electrical Stimulation Paired With Movement-Related Cortical Potentials Improves Isometric Muscle Strength and Voluntary Activation Following Stroke.,"Background
Endogenous paired associative stimulation (ePAS) is a neuromodulatory intervention that has potential to aid stroke recovery. ePAS involves pairing endogenous electroencephalography (EEG) signals known as movement-related cortical potentials (MRCPs), with peripheral electrical stimulation. Previous studies have used transcranial magnetic stimulation (TMS) to demonstrate changes in corticomotor excitability following ePAS. However, the use of TMS as a measure in stroke research is limited by safety precautions, intolerance, and difficulty generating a measurable response in more severely affected individuals. We were interested in evaluating the effect of ePAS using more feasible measures in people with stroke. This study asks whether ePAS produces immediate improvements in the primary outcomes of maximal voluntary isometric contraction (MVIC) and total neuromuscular fatigue of the dorsiflexor muscles, and in the secondary outcomes of muscle power, voluntary activation (VA), central fatigue, peripheral fatigue, and electromyography activity.
Method
In this repeated-measures cross-over study, 15 participants with chronic stroke completed two interventions, ePAS and sham, in a randomized order. During ePAS, 50 repetitions of visually cued dorsiflexion were completed, while single pulses of electrical stimulation were delivered to the deep branch of the common peroneal nerve. Each somatosensory volley was timed to arrive in the primary motor cortex at the peak negativity of the MRCP. Univariate and multivariate linear mixed models were used to analyze the primary and secondary data, respectively.
Results
There was a statistically significant increase in dorsiflexor MVIC immediately following the ePAS intervention (mean increase 7 N), compared to the sham intervention (mean change 0 N) (univariate between-condition analysis p = 0.047). The multivariate analysis revealed a statistically significant effect of ePAS on VA of the tibialis anterior muscle, such that ePAS increased VA by 7 percentage units (95% confidence interval 1.3-12.7%). There was no statistically significant effect on total neuromuscular fatigue, muscle power, or other secondary measures.
Conclusion
A single session of ePAS can significantly increase isometric muscle strength and VA in people with chronic stroke. The findings confirm that ePAS has a central neuromodulatory mechanism and support further exploration of its potential as an adjunct to stroke rehabilitation. In addition, the findings offer alternative, feasible outcome measures for future research.
Clinical trial registration
Australia New Zealand Clinical Trials Registry ACTRN12617000838314 (www.anzctr.org.au), Universal Trial Number U111111953714.",2020,"There was no statistically significant effect on total neuromuscular fatigue, muscle power, or other secondary measures.
","['people with chronic stroke', 'people with stroke', '15 participants with chronic stroke']","['ePAS', 'TMS', 'Peripheral Electrical Stimulation Paired With Movement-Related Cortical Potentials', '\n\n\nEndogenous paired associative stimulation (ePAS', 'transcranial magnetic stimulation (TMS']","['dorsiflexor MVIC', 'muscle power, voluntary activation (VA), central fatigue, peripheral fatigue, and electromyography activity', 'isometric muscle strength and VA', 'maximal voluntary isometric contraction (MVIC) and total neuromuscular fatigue of the dorsiflexor muscles', 'Isometric Muscle Strength and Voluntary Activation', 'total neuromuscular fatigue, muscle power, or other secondary measures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",15.0,0.169883,"There was no statistically significant effect on total neuromuscular fatigue, muscle power, or other secondary measures.
","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Olsen', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Signal', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Imran K', 'Initials': 'IK', 'LastName': 'Niazi', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Rashid', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Alder', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Mawston', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Rasmus B', 'Initials': 'RB', 'LastName': 'Nedergaard', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Jochumsen', 'Affiliation': 'Center for Sensory-Motor Interaction, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00156']
2655,32499697,"Right Dose, Right Now: Development of AutoKinetics for Real Time Model Informed Precision Antibiotic Dosing Decision Support at the Bedside of Critically Ill Patients.","Introduction
Antibiotic dosing in critically ill patients is challenging because their pharmacokinetics (PK) are altered and may change rapidly with disease progression. Standard dosing frequently leads to inadequate PK exposure. Therapeutic drug monitoring (TDM) offers a potential solution but requires sampling and PK knowledge, which delays decision support. It is our philosophy that antibiotic dosing support should be directly available at the bedside through deep integration into the electronic health record (EHR) system. Therefore we developed AutoKinetics, a clinical decision support system (CDSS) for real time, model informed precision antibiotic dosing.
Objective
To provide a detailed description of the design, development, validation, testing, and implementation of AutoKinetics.
Methods
We created a development framework and used workflow analysis to facilitate integration into popular EHR systems. We used a development cycle to iteratively adjust and expand AutoKinetics functionalities. Furthermore, we performed a literature review to select and integrate pharmacokinetic models for five frequently prescribed antibiotics for sepsis. Finally, we tackled regulatory challenges, in particular those related to the Medical Device Regulation under the European regulatory framework.
Results
We developed a SQL-based relational database as the backend of AutoKinetics. We developed a data loader to retrieve data in real time. We designed a clinical dosing algorithm to find a dose regimen to maintain antibiotic pharmacokinetic exposure within clinically relevant safety constraints. If needed, a loading dose is calculated to minimize the time until steady state is achieved. Finally, adaptive dosing using Bayesian estimation is applied if plasma levels are available. We implemented support for five extensively used antibiotics following model development, calibration, and validation. We integrated AutoKinetics into two popular EHRs (Metavision, Epic) and developed a user interface that provides textual and visual feedback to the physician.
Conclusion
We successfully developed a CDSS for real time model informed precision antibiotic dosing at the bedside of the critically ill. This holds great promise for improving sepsis outcome. Therefore, we recently started the Right Dose Right Now multi-center randomized control trial to validate this concept in 420 patients with severe sepsis and septic shock.",2020,"Therefore we developed AutoKinetics, a clinical decision support system (CDSS) for real time, model informed precision antibiotic dosing.
","['Critically Ill Patients', 'critically ill patients', '420 patients with severe sepsis and septic shock']",['Therapeutic drug monitoring (TDM'],[],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C1720825', 'cui_str': 'Therapeutic Drug Monitoring'}]",[],420.0,0.0731147,"Therefore we developed AutoKinetics, a clinical decision support system (CDSS) for real time, model informed precision antibiotic dosing.
","[{'ForeName': 'Luca F', 'Initials': 'LF', 'LastName': 'Roggeveen', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Tingjie', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Driessen', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Fleuren', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Thoral', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Peter H J', 'Initials': 'PHJ', 'LastName': 'van der Voort', 'Affiliation': 'Intensive Care Unit, OLVG Oost, Amsterdam, Netherlands.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Bosman', 'Affiliation': 'Intensive Care Unit, OLVG Oost, Amsterdam, Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.00646']
2656,32499886,The effectiveness of two different multimodal training modes on physical performance in elderly.,"The study compared the effect of 12-week multimodal training programme performed twice a week at the regular exercise facility (REF) with the 12-week multimodal training programme performed three times per week as a part of the research programme (EX). Additionally, the study analysed how the experimental training programme affect the physical performance of cognitive healthy and mild cognitive impaired elderly (MCI). The REF training group included 19 elderly (65.00±3.62 years). The experimental training programme combined cognitively healthy (EXH: n=16; 66.3±6.42 years) and age-matched individuals with MCI (EXMCI: n=14; 66.00±4.79 years). 10m maximal walking speed (10mMWS), Five Times Sit-to-Stand Test (FTSS), maximal and relative voluntary contraction (MVC & rel. MVC) were analysed. The REF group improved in 10mMWS (t=2.431, p=.026), the MVC (t=-3.528, p=.002) and relative MVC (t=3.553, p=.002). The EXH group improved in FTSS (t=5.210, P=.000), MVC (t=2.771, p=.018) and relative MVC (t=-3.793, p=.004). EXMCI improved in FTSS (t=2.936, p=.012) and MVC (t=-2.276, p=.040). According to results, both training programmes sufficiently improved walking speed and muscle strength in cognitively healthy elderly. Moreover, the experimental training programme improved muscle strength in MCI elderly.",2020,"The EXH group improved in FTSS (t=5.210, P=.000), MVC (t=2.771, p=.018) and relative MVC (t=-3.793, p=.004).","['group included 19 elderly (65.00±3.62 years', 'cognitively healthy elderly', 'cognitive healthy and mild cognitive impaired elderly (MCI', 'cognitively healthy (EXH: n=16; 66.3±6.42 years) and age-matched individuals with MCI (EXMCI: n=14; 66.00±4.79 years', 'elderly']","['multimodal training modes', 'EXH', 'REF training', 'multimodal training programme']","['10m maximal walking speed (10mMWS), Five Times Sit-to-Stand Test (FTSS), maximal and relative voluntary contraction (MVC & rel', 'relative MVC', 'FTSS', 'walking speed and muscle strength', 'muscle strength', 'EXMCI improved in FTSS', 'MVC']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0035018', 'cui_str': 'rel Oncogene'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",19.0,0.0101218,"The EXH group improved in FTSS (t=5.210, P=.000), MVC (t=2.771, p=.018) and relative MVC (t=-3.793, p=.004).","[{'ForeName': 'Ľudmila', 'Initials': 'Ľ', 'LastName': 'Oreská', 'Affiliation': 'Department of Biological and Medical Sciences, Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Slobodová', 'Affiliation': 'Institute of Pathophysiology, Faculty of Medicine, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Matej', 'Initials': 'M', 'LastName': 'Vajda', 'Affiliation': 'Department of Biological and Medical Sciences, Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Kaplánová', 'Affiliation': 'Department of Sport Sciences in Educology and Humanities, Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Tirpáková', 'Affiliation': 'Institute of Sports Medicine, Faculty of Medicine, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Ján', 'Initials': 'J', 'LastName': 'Cvečka', 'Affiliation': 'Diagnostic Centre of Professor Hamar, Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Buzgó', 'Affiliation': 'Department of Biological and Medical Sciences, Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Institute of Pathophysiology, Faculty of Medicine, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ukropcová', 'Affiliation': 'Department of Biological and Medical Sciences, Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Sedliak', 'Affiliation': 'Department of Biological and Medical Sciences, Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}]",European journal of translational myology,['10.4081/ejtm.2019.8820']
2657,32499918,Effect of Helicobacter pylori -eradication therapy on hepatic steatosis in patients with non-alcoholic fatty liver disease: a randomized-controlled pilot study.,"Background
Helicobacter pylori infection has been associated with insulin resistance and non-alcoholic fatty liver disease (NAFLD). This study was done to evaluate the effect of H. pylori -eradication therapy (HPET) in patients with NAFLD compared to standard management therapy (SMT).
Methods
Eighty NAFLD patients with H. pylori co-infection were randomized into SMT (diet and exercise, n = 36) and HPET (SMT plus amoxicillin, clarithromycin, and pantoprazole, n = 44) groups. The controlled attenuation parameter (CAP), anthropometric parameters, liver enzymes, lipid profile, and glycemic parameters including homeostasis model assessment-insulin resistance (HOMA-IR) were measured and compared between two groups at the baseline and 24 weeks.
Results
Sixty-four participants (SMT group [ n = 28] and HPET group [ n = 36]) were included in a modified intention-to-treat analysis. Both the SMT group and the HPET group had a significant reduction in CAP scores at 24 weeks ( P = 0.002 and P < 0.001, respectively), but the change between the groups was insignificant ( P = 0.213). Successful eradication of H. pylori occurred in 68% of the HPET group and led to greater improvement in HOMA-IR at 24 weeks compared to SMT or non-responder patients ( P = 0.007). The liver enzymes reduced significantly at 24 weeks in both groups, but the changes between the groups were similar. The lipid parameters remained unchanged within the groups and between the groups at 24 weeks. A significant increase in the levels of reduced glutathione was noted in the HPET group, but the change between the two groups was not statistically different.
Conclusions
HPET was found to be comparable to SMT alone in reducing hepatic steatosis and liver enzymes at 24 weeks in NAFLD patients. However, successful eradication of H. pylori led to greater improvement in HOMA-IR (Trial registration CTRI/2017/05/008608).",2020,"Both the SMT group and the HPET group had a significant reduction in CAP scores at 24 weeks ( P = 0.002 and P < 0.001, respectively), but the change between the groups was insignificant ( P = 0.213).","['Eighty NAFLD patients with H. pylori co-infection', 'patients with NAFLD compared to standard management therapy (SMT', 'Sixty-four participants (SMT group [ n\u2009 = \u2009 28] and HPET group [ n\u2009 = \u2009 36]) were included in a modified intention-to-treat analysis', 'patients with non-alcoholic fatty liver disease']","['H. pylori -eradication therapy (HPET', 'HPET', 'SMT', 'SMT (diet and exercise, n\u2009 = \u2009 36) and HPET (SMT plus amoxicillin, clarithromycin, and pantoprazole', 'Helicobacter pylori -eradication therapy']","['Successful eradication of H. pylori', 'controlled attenuation parameter (CAP), anthropometric parameters, liver enzymes, lipid profile, and glycemic parameters including homeostasis model assessment-insulin resistance (HOMA-IR', 'HOMA-IR', 'hepatic steatosis', 'liver enzymes', 'lipid parameters', 'levels of reduced glutathione', 'CAP scores', 'hepatic steatosis and liver enzymes']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.0495854,"Both the SMT group and the HPET group had a significant reduction in CAP scores at 24 weeks ( P = 0.002 and P < 0.001, respectively), but the change between the groups was insignificant ( P = 0.213).","[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Maharshi', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vijay L', 'Initials': 'VL', 'LastName': 'Kumar', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Prasenjit', 'Initials': 'P', 'LastName': 'Das', 'Affiliation': 'Department of Pathology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajni', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Department of Pathology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Baibaswata', 'Initials': 'B', 'LastName': 'Nayak', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shalimar', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.'}]",Gastroenterology report,['10.1093/gastro/goz058']
2658,32500016,Prediction of Gestational Diabetes by Measuring the Levels of Pregnancy Associated Plasma Protein-A (PAPP-A) During Gestation Weeks 11-14.,"Background
The present study aimed to determine the association between pregnancy-associated plasma protein A (PAPP-A) and Gestational Diabetes Methods (GDM) to detect a risk factor for predicting GDM at gestational weeks 11-14.
Methods
This analytical prospective study recruited 284 pregnant women presenting to six healthcare centers of Qazvin, Iran from February to December 2016. PAPP-A was measured at gestational weeks 11-14 and glucose tolerance test was conducted at gestational weeks 24-28. The participants were assigned into two groups of exposure (reduced PAPP-A) and non-exposure (normal PAPP-A). The association between GDM and PAPP-A was studied. The number of women in exposure group were 201 and 83 in the non-exposure group. Differences between groups were assessed by the Mann-Whitney, Chi-square, T test, logistic regression analysis and ROC Curve with a significance level of 0.05.
Results
Twenty eight (33.73%) patients of the exposure group and 17 (8.46%) of non-exposure group developed GDM. There was a significant difference between the two groups in terms of GDM (p<0.001) and the risk of GDM was 3.98 fold higher in the exposure group (reduced PAPPA mu/L ) than that of the non-exposure group (CI=2.39-6.65, p<0.001). Also, 53.3% of the exposure group and 46.7% of the nonexposure group were diagnosed with GDM (p=0.02). There was a significant difference in GDM between the groups and the risk of GDM was 1.85 times higher in the exposure group (reduced PAPPA MOM) than that in the control group (CI=1.09-3.15, p=0.020). According to the ROC curve results, PAPP-A and MOM are acceptable indicators for predicting GDM.
Conclusion
A low PAPP-A level (MOM, MU/L) as a new risk factor for GDM can help early prediction and prevent maternal and fetal complication by timely treatment.",2020,"There was a significant difference in GDM between the groups and the risk of GDM was 1.85 times higher in the exposure group (reduced PAPPA MOM) than that in the control group (CI=1.09-3.15, p=0.020).","['284 pregnant women presenting to six healthcare centers of Qazvin, Iran from February to December 2016']","['PAPP', 'exposure (reduced PAPP-A) and non-exposure (normal PAPP-A']","['GDM', 'risk of GDM', 'PAPPA MOM', 'Levels of Pregnancy Associated Plasma Protein-A (PAPP-A']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0135262', 'cui_str': '1-(2-(4-aminophenyl)ethyl)-4-(3-trifluoromethylphenyl)piperazine'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0232989', 'cui_str': 'Normal pregnancy'}]","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",284.0,0.0325339,"There was a significant difference in GDM between the groups and the risk of GDM was 1.85 times higher in the exposure group (reduced PAPPA MOM) than that in the control group (CI=1.09-3.15, p=0.020).","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ramezani', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahboubeh Ahmadi', 'Initials': 'MA', 'LastName': 'Doulabi', 'Affiliation': 'Midwifery and Reproductive Health Research Center, Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Saqhafi', 'Affiliation': 'School of Paramedical Sciences, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Alipoor', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Journal of reproduction & infertility,[]
2659,32500087,Frailty Is Associated With Increased Hemagglutination-Inhibition Titers in a 4-Year Randomized Trial Comparing Standard- and High-Dose Influenza Vaccination.,"Background
Although high-dose (HD) vaccines have been reported to stimulate higher antibody responses compared with standard-dose (SD) influenza vaccines, there have been limited studies on the impact of frailty on such responses.
Methods
We conducted a randomized, double-blind trial (2014/2015 to 2017/2018) of SD versus HD trivalent split-virus vaccine (Fluzone) in 612 study participants aged 65+ over 4 influenza seasons. Hemagglutination inhibition antibody titers for influenza H1N1, H3N2, and B vaccine subtypes were measured at baseline and at 4, 10, and 20 weeks postvaccination and frailty was measured using a validated frailty index.
Results
Geometric mean antibody titers were significantly higher in HD compared with SD vaccine recipients for all influenza subtypes at all time points postvaccination. However, frailty was positively correlated with 4-week titers and was associated with increased odds of being a vaccine responder. For influenza A subtypes, this was mostly limited to HD recipients.
Conclusions
Frailty was associated with higher titers and increased antibody responses at 4 weeks after influenza vaccination, which was partially dependent on vaccine dosage. Chronic inflammation or dysregulated immunity, both of which are commonly observed with frailty, may be responsible, but it requires further investigation.",2020,Geometric mean antibody titers were significantly higher in HD compared with SD vaccine recipients for all influenza subtypes at all time points postvaccination.,['612 study participants aged 65+\u2005over 4 influenza seasons'],"['SD vaccine', 'influenza', 'SD versus HD trivalent split-virus vaccine (Fluzone']","['antibody responses', 'Geometric mean antibody titers']","[{'cui': 'C4517834', 'cui_str': '612'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}]",612.0,0.267004,Geometric mean antibody titers were significantly higher in HD compared with SD vaccine recipients for all influenza subtypes at all time points postvaccination.,"[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Loeb', 'Affiliation': 'Health Sciences North Research Institute, Sudbury, Ontario, Canada.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Andrew', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loeb', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Ontario, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Kuchel', 'Affiliation': 'UConn Center on Aging, University of Connecticut School of Medicine, Farmington, Connecticut, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Haynes', 'Affiliation': 'UConn Center on Aging, University of Connecticut School of Medicine, Farmington, Connecticut, USA.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'McElhaney', 'Affiliation': 'Health Sciences North Research Institute, Sudbury, Ontario, Canada.'}, {'ForeName': 'Chris P', 'Initials': 'CP', 'LastName': 'Verschoor', 'Affiliation': 'Health Sciences North Research Institute, Sudbury, Ontario, Canada.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa148']
2660,32500486,"The Antidiabetic Metformin as an Adjunct to Antidepressants in Patients with Major Depressive Disorder: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.","Metformin (MET) has been reported to have antidepressant effects in animal models and in diabetic patients with depression, owing to its anti-inflammatory, antioxidant, and neuroprotective activity. Accordingly, we proposed that MET would show antidepressant effects in patients with major depressive disorder (MDD) without other comorbidities. In this double-blind placebo-controlled study, 80 adult outpatients with MDD (DSM-IV criteria) and a Hamilton Depression Rating Scale (HAM-D) score >18 were randomized to receive fluoxetine 20 mg once daily plus placebo (n = 40) or fluoxetine 20 mg once daily plus MET 1000 mg once daily for 12 weeks. Patients were assessed by HAM-D score (weeks 0, 4, 8, and 12). The serum levels of TNF-α, IL-1β, IL-6, IGF-1, MDA, CRP, BDNF, and serotonin were measured before and after therapy. Mixed-effects model repeated-measures analysis of covariance was used to compare the HAM-D scores and the biological markers between the two groups. After 4, 8 and 12 weeks, patients in the MET group showed a statistically significant decline in HAM-D score relative to the placebo group (least squares mean difference [LSMD] -2.347, p = 0.000, LSMD -3.369, p = 0.000, and LSMD -3.454, p = 0.000, respectively). Response and remission rates were significantly higher in the MET group (89% and 81%, respectively) than in the placebo group (59% and 46%, respectively). Moreover, the MET group was superior in conserving the measured biological markers compared with the placebo group. Our findings suggest MET as a promising, effective, and safe short-term adjunctive approach in nondiabetic MDD patients. Trial registration ID: NCT04088448.",2020,"After 4, 8 and 12 weeks, patients in the MET group showed a statistically significant decline in HAM-D score relative to the placebo group (least squares mean difference [LSMD] -2.347, p = 0.000, LSMD -3.369, p = 0.000, and LSMD -3.454, p = 0.000, respectively).","['patients with major depressive disorder (MDD) without other comorbidities', 'diabetic patients with depression', 'Patients with Major Depressive Disorder', '80 adult outpatients with MDD (DSM-IV criteria) and a Hamilton Depression Rating Scale (HAM-D) score >18', 'nondiabetic MDD patients']","['Placebo', 'fluoxetine 20 mg once daily plus placebo', 'Metformin (MET', 'Antidiabetic Metformin', 'fluoxetine 20 mg once daily plus MET', 'placebo']","['HAM-D scores and the biological markers', 'HAM-D score relative', 'serum levels of TNF-α, IL-1β, IL-6, IGF-1, MDA, CRP, BDNF, and serotonin', 'HAM-D score', 'Response and remission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0986112', 'cui_str': 'Fluoxetine 20 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",80.0,0.301389,"After 4, 8 and 12 weeks, patients in the MET group showed a statistically significant decline in HAM-D score relative to the placebo group (least squares mean difference [LSMD] -2.347, p = 0.000, LSMD -3.369, p = 0.000, and LSMD -3.454, p = 0.000, respectively).","[{'ForeName': 'Mahmoud S', 'Initials': 'MS', 'LastName': 'Abdallah', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, University of Sadat City (USC), Sadat City, Menoufia, 32897, Egypt. Mahmoud.samy@fop.usc.edu.eg.'}, {'ForeName': 'Esraa M', 'Initials': 'EM', 'LastName': 'Mosalam', 'Affiliation': 'Department of Biochemistry, Faculty of Pharmacy, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Abdel-Aziz A', 'Initials': 'AA', 'LastName': 'Zidan', 'Affiliation': 'Zoology Department, Faculty of Science, Damanhour University, Damanhour & Center of Excellence in Cancer Research (CECR), Tanta University, Tanta, Egypt.'}, {'ForeName': 'Khaled S', 'Initials': 'KS', 'LastName': 'Elattar', 'Affiliation': 'Consultant of Psychiatry & Private Psychiatric Hospital Manager, 10th of Ramadan, Egypt.'}, {'ForeName': 'Shimaa A', 'Initials': 'SA', 'LastName': 'Zaki', 'Affiliation': 'Department of Clinical Biochemistry and Molecular Diagnostics, National Liver Institute, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Ahmed N', 'Initials': 'AN', 'LastName': 'Ramadan', 'Affiliation': 'Department of Neuropsychiatry, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Abla M', 'Initials': 'AM', 'LastName': 'Ebeid', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Delta University for Science and Technology, Gamasaa, Egypt.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-020-00878-7']
2661,32500519,The impact of athletic clothing style and body awareness on motor performance in women.,"The type of clothing worn, revealing versus concealing, can affect the performance of women on cognitive tasks. This difference in performance may arise because of changes in body awareness that may draw cognitive resources from the goal task. The present study investigated the influence of the style of athletic clothing and body awareness on visual-motor performance in women. Participants (women ages 18-35 years) were randomly assigned to wear tight and revealing (TR group, n = 40) or loose and concealing (LC group, n = 40) athletic clothing. All participants completed the same visual-motor aiming task to assess spatiotemporal measures of motor performance. In addition to the clothing, participants were primed to be conscious of their bodies via measurements of height, weight, and waist circumference; photographs taken of their bodies; a computerized body-size distortion task; and a mirror in the testing chamber. Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group. These differences suggest that style of clothing may influence motor performance in women by reallocating cognitive resources towards the body and away from the motor task at hand. This research highlights the interactions between cognitive and motor processes and, potentially, the importance of considering the impact of clothing on performance in many different contexts.",2020,Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group.,"['Participants (women ages 18-35 years', 'women']","['wear tight and revealing (TR group, n = 40) or loose and concealing (LC group, n = 40) athletic clothing', 'athletic clothing and body awareness', 'athletic clothing style and body awareness']","['visual-motor performance', 'movement time variability', 'motor performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",40.0,0.11005,Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Department of Psychology, Faculty of Arts & Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sabiston', 'Affiliation': 'Mental Health and Physical Activity Research Centre, Faculty of Kinesiology & Physical Education, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Karlinsky', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Manzone', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather F', 'Initials': 'HF', 'LastName': 'Neyedli', 'Affiliation': 'Kinesiology, School of Health and Human Performance, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Timothy N', 'Initials': 'TN', 'LastName': 'Welsh', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada. t.welsh@utoronto.ca.'}]",Psychonomic bulletin & review,['10.3758/s13423-020-01755-2']
2662,32500569,A randomised controlled trial of fibrinogen concentrate during scoliosis surgery.,"Bleeding and blood transfusion are common after scoliosis surgery. Fibrinogen is essential for blood clot formation and depletes quickly during haemorrhage. We randomly allocated 102 children 12-18 years old having surgery for idiopathic scoliosis, 51 to intra-operative fibrinogen concentrate 30 mg.kg -1 (maximum 2 g) and 51 to saline placebo. Fibrinogen reduced peri-operative blood loss by a median (95%CI) volume of 155 (5-320) ml, from a median (IQR [range]) of 1035 (818-1420 [400-3030]) ml to 885 (755-1155 [270-2645]) ml, p = 0.04. Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34. There were no side-effects.",2020,"Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34.","['scoliosis surgery', '102 children 12-18\xa0years old having surgery for idiopathic scoliosis, 51 to intra-operative fibrinogen concentrate 30']","['fibrinogen concentrate', 'saline placebo']","['Bleeding and blood transfusion', 'allogeneic red blood cell transfusion', 'Fibrinogen reduced peri-operative blood loss']","[{'cui': 'C0854477', 'cui_str': 'Scoliosis surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}]","[{'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",11.0,0.601726,"Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Orthopedics Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Orthopedics Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}]",Anaesthesia,['10.1111/anae.15124']
2663,32500650,Long-term health-related quality of life among men with prostate cancer in the Finnish randomized study of screening for prostate cancer.,"BACKGROUND
The long-term health-related quality of life (HRQOL) impacts of PCa screening have not been adequately evaluated. We aimed to compare the generic and disease-specific health-related quality of life (HRQOL) among men with prostate cancer in the screening arm with the control arm of the PSA-based prostate cancer screening trial in up to 15 years of follow-up.
MATERIALS AND METHODS
This study was conducted within population-based Finnish Randomized Study of Screening for Prostate Cancer (FinRSPC). During 1996-1999 80,458 men were randomized to the serum prostate-specific antigen (PSA) screening arm (SA, N = 32 000) and the control arm (CA, N = 48 458). Men in the screening arm were screened at 4-year intervals until 2007. HRQOL questionnaires were delivered to newly diagnosed prostate cancer patients in the screening and control arm 1996-2006 (N = 5128) at the time of diagnosis (baseline), at 3-month, 12-month and 5, 10, and 15-year follow-up. Validated UCLA Prostate Cancer Index (UCLA-PCI) and RAND 36-Item Health Survey were used for HRQOL assessment. The data were analyzed with a random effects model for repeated measures.
RESULTS
At baseline, men with prostate cancer in the screening arm reported better Sexual Function, as well as less Sexual and Urinary Bother. Long-term follow-up revealed slightly higher HRQOL scores in the screening arm in prostate cancer specific measures at 10-year post diagnosis, but the differences were statistically significant only in Urinary Bother (UCLA-PCI score 77.9; 95% CI 75.2 to 80.5 vs. 70.9; 95% CI 66.8 to 74.9 P = .005).The generic HRQOL scores were comparable between the trial arms. The overall differences in disease-specific or generic HRQOL scores by trial arm did not vary during the follow-up.
CONCLUSION
No major differences were observed in HRQOL in men with prostate cancer between the prostate cancer screening and control arms during five to 15-year follow-up.",2020,"Long-term follow-up revealed slightly higher HRQOL scores in the screening arm in prostate cancer specific measures at 10-year post diagnosis, but the differences were statistically significant only in Urinary Bother (UCLA-PCI score 77.9; 95% CI 75.2 to 80.5 vs. 70.9; 95% CI 66.8 to 74.9 P = .005).The generic HRQOL scores were comparable between the trial arms.","['Men in the screening arm were screened at 4-year intervals until 2007', 'newly diagnosed prostate cancer patients in the screening and control arm 1996-2006', 'population-based Finnish Randomized Study of Screening for Prostate Cancer (FinRSPC', 'men with prostate cancer in the Finnish randomized study of screening for prostate cancer', 'men with prostate cancer in the screening arm with the control arm of the PSA-based prostate cancer screening trial in up to 15\xa0years of follow-up', 'During 1996-1999 80,458 men']",['serum prostate-specific antigen (PSA) screening'],"['HRQOL questionnaires', 'Validated UCLA Prostate Cancer Index (UCLA-PCI) and RAND 36-Item Health Survey', 'Urinary Bother (UCLA-PCI score', 'HRQOL', 'HRQOL scores', 'generic HRQOL scores', 'disease-specific or generic HRQOL scores', 'generic and disease-specific health-related quality of life (HRQOL', 'Sexual Function']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",80458.0,0.0974762,"Long-term follow-up revealed slightly higher HRQOL scores in the screening arm in prostate cancer specific measures at 10-year post diagnosis, but the differences were statistically significant only in Urinary Bother (UCLA-PCI score 77.9; 95% CI 75.2 to 80.5 vs. 70.9; 95% CI 66.8 to 74.9 P = .005).The generic HRQOL scores were comparable between the trial arms.","[{'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Heinävaara', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Ulf-Håkan', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Clinical Chemistry and Hematology, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Nea', 'Initials': 'N', 'LastName': 'Malila', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Faculty of Social Sciences/Health Sciences, Tampere University, Tampere, Finland.'}]",Cancer medicine,['10.1002/cam4.3181']
2664,32500827,"Effects of long-term administration of Multi-Strain Probiotic on circulating levels of BDNF, NGF, IL-6 and mental health in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled trial.","Background: Mental disorders is one of the main causes of disability and lower life expectancy among patients with Multiple Sclerosis (MS). The present trial aimed to examine the efficacy of multi-strain probiotic supplementation on circulating levels of BDNF, NGF, IL-6 and mental health in patients with MS. Methods: This trial was conducted among 70 patients with MS that referred to the MS Association. Patients were randomized into intervention and control groups to receive 2 multi-strain probiotic capsules or placebo, daily for six months. Serum BDNF, NGF and IL-6 was measured by ELISA kits. Mental health parameters were assessed by valid questionnaires in the baseline and end of the study. Results: Of the 70 patients enrolled in this study, 65 subjects were included in the final analysis. From baseline to 6 months, probiotic supplementation resulted in a significant increase in BDNF and a significant reduction in the IL-6 levels ( P < 0.001). Our findings revealed that probiotic supplementation compared to placebo caused a significant improvement in the general health questionnaire-28 (GHQ-28) (-5.31 ± 4.62 vs. -1.81 ± 4.23; P = 0.002), Beck Depression Inventory-II (BDI-II) (-4.81 ± 0.79 vs. -1.90 ± 0.96; P = 0.001), Fatigue Severity Scale (FSS) (-3.81 ± 6.56 vs. 0.24 ± 5.44; P = 0.007) and Pain Rating Index (PRI) (-3.15 ± 4.51 vs. -0.09 ± 3.67; P = 0.004). However, we not found any significant difference between the two groups in other factors ( P > 0.05). Conclusion: Overall, six months of probiotic supplementation resulted in greater improvement in mental health parameters.",2020,"Our findings revealed that probiotic supplementation compared to placebo caused a significant improvement in the general health questionnaire-28 (GHQ-28) (-5.31 ± 4.62 vs. -1.81 ± 4.23; P = 0.002), Beck Depression Inventory-II (BDI-II) (-4.81 ± 0.79 vs. -1.90 ± 0.96; P = 0.001), Fatigue Severity Scale (FSS) (-3.81 ± 6.56 vs. 0.24 ± 5.44; P = 0.007) and Pain Rating Index (PRI)","['70 patients enrolled in this study, 65 subjects were included in the final analysis', 'patients with MS', '70 patients with MS that referred to the MS Association', 'patients with Multiple Sclerosis (MS', 'patients with multiple sclerosis']","['Multi-Strain Probiotic', 'probiotic supplementation', 'multi-strain probiotic supplementation', '2 multi-strain probiotic capsules or placebo', 'placebo']","['BDNF', 'Serum BDNF, NGF and IL-6', 'Pain Rating Index (PRI', 'Mental health parameters', 'general health questionnaire-28 (GHQ-28', 'IL-6 levels', 'circulating levels of BDNF, NGF, IL-6 and mental health', 'Fatigue Severity Scale (FSS', 'mental health parameters', 'Beck Depression Inventory-II (BDI-II']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0265224', 'cui_str': 'Freeman-Sheldon syndrome'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}]",70.0,0.367968,"Our findings revealed that probiotic supplementation compared to placebo caused a significant improvement in the general health questionnaire-28 (GHQ-28) (-5.31 ± 4.62 vs. -1.81 ± 4.23; P = 0.002), Beck Depression Inventory-II (BDI-II) (-4.81 ± 0.79 vs. -1.90 ± 0.96; P = 0.001), Fatigue Severity Scale (FSS) (-3.81 ± 6.56 vs. 0.24 ± 5.44; P = 0.007) and Pain Rating Index (PRI)","[{'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Rahimlou', 'Affiliation': 'Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Seyed Ahmad', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Majdinasab', 'Affiliation': 'Department of Neurology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Haghighizadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health Ahvaz Jundishapur University of Medical sciences, Ahvaz, Iran.'}, {'ForeName': 'Durdana', 'Initials': 'D', 'LastName': 'Husain', 'Affiliation': 'Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Nutritional neuroscience,['10.1080/1028415X.2020.1758887']
2665,32500862,D-PLEX500: a local biodegradable prolonged release doxycycline-formulated bone graft for the treatment for peri-implantitis. A randomized controlled clinical study.,"OBJECTIVES
In the present pilot, multicenter, randomized, single-blinded, controlled study, surgical treatment with or without the administration of D-PLEX500 (a biodegradable prolonged release local doxycycline formulated with β-tricalcium phosphate bone graft) was accessed for the treatment of peri-implantitis.
METHOD AND MATERIALS
Subjects undergoing surgical treatment for intrabony peri-implantitis defects after flap elevation were randomly assigned, to adjunct D-PLEX500 placement group or to control group. Clinical and radiographic parameters were measured at 6 and 12 months.
RESULTS
Twenty-seven subjects (average age: 64.81 ± 7.61 years) were enrolled; 14 patients (18 implants) were randomized to the test group and 13 (14 implants) to the control group. There was no difference in plaque scores between the groups. There was no difference in the changes of mean periodontal probing depth between the test and control groups between baseline and the 6-month follow-up, whereas statistically significant difference was observed after 12 months' follow-up when analyzed for all sites averaged. There was a statistically significant difference in the changes of clinical attachment levels and radiographic bone levels between the groups between baseline and 12 months. These improvements were demonstrated when analyzed at both implant and subject levels. Only D-PLEX500 treatment led to improved bone levels at both time points. The improvement in bone levels was significant in the D-PLEX500 treatment group already after 6 months, and further improved over the 12-month follow-up. Implants were lost only in the control group (14%).
CONCLUSIONS
D-PLEX500 sustained release local antibiotic formulated with bone filler showed promising results in enabling healing of peri-implantitis lesions. The antibacterial component of the bone graft material might create favorable conditions that enable implant surface decontamination and soft and hard tissue healing over a prolonged period.",2020,D-PLEX500 sustained release local antibiotic formulated with bone filler showed promising results in enabling healing of peri-implantitis lesions.,"['Twenty-seven subjects (average age: 64.81 ± 7.61 years) were enrolled; 14 patients (18 implants', 'peri-implantitis', 'Subjects undergoing surgical treatment for intrabony peri-implantitis defects after flap elevation']","['doxycycline-formulated bone graft', 'adjunct D-PLEX500 placement group or to control group', 'D-PLEX500']","['mean periodontal probing depth', 'bone levels', 'Clinical and radiographic parameters', 'plaque scores', 'clinical attachment levels and radiographic bone levels']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1882337', 'cui_str': 'Periodontal probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",27.0,0.0378858,D-PLEX500 sustained release local antibiotic formulated with bone filler showed promising results in enabling healing of peri-implantitis lesions.,"[{'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Emanuel', 'Affiliation': ''}, {'ForeName': 'Eli E', 'Initials': 'EE', 'LastName': 'Machtei', 'Affiliation': ''}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Reichart', 'Affiliation': ''}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Shapira', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44629']
2666,32500957,No evidence of a legacy effect on survival following randomization to extended hours dialysis in the ACTIVE Dialysis trial.,"AIM
Extended hours hemodialysis is associated with superior survival to standard hours. However, residual confounding limits the interpretation of this observation. We aimed to determine the effect of a period of extended hours dialysis on long-term survival among participants in the ACTIVE Dialysis trial.
METHODS
Two-hundred maintenance hemodialysis recipients were randomized to extended hours dialysis (median 24 hours/week) or standard hours dialysis (median 12 hours/week) for 12 months. Further pre-specified observational follow up occurred at 24, 36 and 60 months. Vital status and modality of renal replacement therapy were ascertained.
RESULTS
Over the 5 years, 38 participants died, 30 received a renal transplant, and 6 were lost to follow up. Total weekly dialysis hours did not differ between standard and extended groups during the follow up period (14.1 h [95%CI 13.4-14.8] vs 14.8 h [95%CI 14.1-15.6]; P = .16). There was no difference in all-cause mortality (hazard ratio for extended hours 0.91 [95%CI 0.48-1.72]; P = .77). Similar results were obtained after censoring participants at transplantation, and after adjusting for potential confounding variables. Subgroup analysis did not reveal differences in treatment effect by region, dialysis setting or vintage (P-interaction .51, .54, .12, respectively).
CONCLUSIONS
Twelve months of extended hours dialysis did not improve long-term survival nor affect dialysis hours after the intervention period. An urgent need remains to further define the optimal dialysis intensity across the broad range of dialysis recipients.
TRIAL REGISTRATION
Clinicaltrials.gov Identifier: NCT00649298.",2020,There was no difference in all-cause mortality (hazard ratio for extended hours 0.91,"['38 participants died, 30 received a renal transplant, and 6 were lost to follow up', 'participants in the ACTIVE Dialysis trial', 'Two-hundred maintenance hemodialysis recipients']",[],"['cause mortality', 'Total weekly dialysis hours', 'long-term survival', 'survival']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",200.0,0.23794,There was no difference in all-cause mortality (hazard ratio for extended hours 0.91,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Gray', 'Affiliation': 'Sunshine Coast University Hospital, Australia.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'University Health Network, Toronto, Canada.'}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Hong', 'Affiliation': ""Renal Department, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""General Practice Department, Sichuan Provincial People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health and University of New South Wales, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology (Carlton, Vic.)",['10.1111/nep.13737']
2667,32500964,Effect of different fraction of inspired oxygen on development of atelectasis in mechanically ventilated children: A randomized controlled trial-A Comment.,,2020,,['mechanically ventilated children'],['fraction of inspired oxygen'],[],"[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",[],,0.281644,,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Swarup', 'Initials': 'S', 'LastName': 'Ray', 'Affiliation': 'Department of Pediatric Anaesthesia, King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai, India.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Yaddanapudi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Paediatric anaesthesia,['10.1111/pan.13854']
2668,32501109,Temporary Bridge Plating vs Primary Arthrodesis of the First Tarsometatarsal Joint in Lisfranc Injuries: Randomized Controlled Trial.,"BACKGROUND
Unstable Lisfranc injuries are best treated with anatomic reduction and stable fixation. There are controversies regarding which type of stabilization is best. In the present study, we compared primary arthrodesis of the first tarsometatarsal (TMT) joint to temporary bridge plating in unstable Lisfranc injuries.
METHODS
Forty-eight patients with Lisfranc injuries were included and followed for 2 years. Twenty-four patients were randomized to primary arthrodesis (PA) of the medial 3 TMT joints, whereas 24 patients were randomized to temporary bridge plate (BP) over the first TMT joint and primary arthrodesis of the second and third TMT joints. The main outcome parameter was the American Orthopaedic Foot & Ankle Society (AOFAS) midfoot scale and the secondary outcome parameters were the 36-Item Short Form Health Survey (SF-36) and visual analog scale for pain (VAS pain). Computed tomography (CT) scans pre- and postoperatively were obtained. Radiographs were obtained at follow-ups. Pedobarographic examination was performed at the 2-year follow-up. Twenty-two of 24 patients in the PA and 23/24 in the BP group completed the 2-year follow-up.
RESULTS
The mean AOFAS midfoot score 2 years postoperatively was 89 (SD 9) in the PA group and 85 (SD 15) in the BP group ( P = .32). There were no significant differences between the groups with regard to SF-36 or VAS pain scores. The alignment of the first metatarsal was better in the BP group than in the PA group measured by the anteroposterior Meary angle ( P = .04). The PA group had a reduced peak pressure under the fifth metatarsal ( P = .047). In the BP group, 11/24 patients had radiologic signs of osteoarthritis in the first TMT joint.
CONCLUSION
Both treatment groups had good outcome scores. The first metatarsal was better aligned in the BP group; however, there was a high incidence of radiographic osteoarthritis in this group.
LEVEL OF EVIDENCE
Therapeutic level I, prospective randomized controlled study.",2020,There were no significant differences between the groups with regard to SF-36 or VAS pain scores.,"['Twenty-four patients were randomized to primary arthrodesis (PA) of the medial 3 TMT joints, whereas 24 patients', 'Twenty-two of 24 patients in the PA and 23/24 in the BP group completed the 2-year follow-up', 'Lisfranc Injuries', 'Forty-eight patients with Lisfranc injuries were included and followed for 2 years']","['primary arthrodesis of the first tarsometatarsal (TMT) joint to temporary bridge plating', 'temporary bridge plate (BP) over the first TMT joint and primary arthrodesis of the second and third TMT joints', 'Temporary Bridge Plating vs Primary Arthrodesis']","['peak pressure', 'Therapeutic level', 'mean AOFAS midfoot score', 'SF-36 or VAS pain scores', 'American Orthopaedic Foot & Ankle Society (AOFAS) midfoot scale', 'radiographic osteoarthritis', '36-Item Short Form Health Survey (SF-36) and visual analog scale for pain (VAS pain', 'radiologic signs of osteoarthritis']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224724', 'cui_str': 'Structure of tarsometatarsal joint'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4523968', 'cui_str': 'Lisfranc injury'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}, {'cui': 'C0447821', 'cui_str': 'First tarsometatarsal joint'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0447823', 'cui_str': 'Third tarsometatarsal joint'}]","[{'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0932074', 'cui_str': 'Midfoot region of foot'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",48.0,0.0430063,There were no significant differences between the groups with regard to SF-36 or VAS pain scores.,"[{'ForeName': 'Are H', 'Initials': 'AH', 'LastName': 'Stødle', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kjetil H', 'Initials': 'KH', 'LastName': 'Hvaal', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helga M', 'Initials': 'HM', 'LastName': 'Brøgger', 'Affiliation': 'Department of Radiology and Nuclear medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elisabeth Ellingsen', 'Initials': 'EE', 'LastName': 'Husebye', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",Foot & ankle international,['10.1177/1071100720925815']
2669,32501127,Injection versus decompression for carpal tunnel syndrome (INDICATE): feasibility trial.,,2020,,['carpal tunnel syndrome (INDICATE'],['Injection versus decompression'],[],"[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}]",[],,0.0129928,,"[{'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Berwin', 'Affiliation': 'Gloucestershire Royal Hospital, Gloucester, UK.'}, {'ForeName': 'Cushla', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Mason', 'Affiliation': 'Gloucestershire Royal Hospital, Gloucester, UK.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420929249']
2670,32501212,The effects of mandibular advancement appliance therapy on jaw-closing muscle activity during sleep in patients with obstructive sleep apnea: a 3-6 months follow-up.,"STUDY OBJECTIVES
The main aim of this study was to investigate the effects of mandibular advancement appliance (MAA) therapy on jaw-closing muscle activity (JCMA) time-related to respiratory arousals, and on JCMA time-related to non-respiratory arousals in patients with obstructive sleep apnea (OSA).
METHODS
Eighteen patients with OSA (mean ± SD = 49.4 ± 9.8 years) with a mean ± SD apnea-hypopnea index (AHI) of 22.0 ± 16.0 events/hour of sleep participated in a randomized controlled crossover trial, in which two ambulatory polysomnographic recordings, one with an MAA in situ and another without the MAA in situ, were performed. JCMA was quantified as the sum of rhythmic masticatory muscle activities and other orofacial activities.
RESULTS
Significant reductions in the AHI (Z = -2.984; P = 0.003), in the respiratory arousal index (Z = - 2.896; P = 0.004), and in the JCMA time-related to respiratory arousal index (Z = -3.434; P = 0.001) were found with MAA in situ. On the non-respiratory arousal index, and on the JCMA time-related to non-respiratory arousal index, MAA had no significant effect (T = 2.23; P = 0.82; and Z = - 0.66; P = 0.51, respectively).
CONCLUSIONS
This study shows that effective mandibular advancement appliance therapy significantly reduces jaw-closing muscle activities time-related to respiratory arousals in OSA patients. Future studies are needed to confirm these findings in OSA patients with comorbid sleep bruxism.
CLINICAL TRIAL REGISTRATION
Registry: ClinicalTrials.gov, Identifier: NCT02011425.",2020,"RESULTS
Significant reductions in the AHI (Z = -2.984; P = 0.003), in the respiratory arousal index (Z = - 2.896; P = 0.004), and in the JCMA time-related to respiratory arousal index (Z = -3.434; P = 0.001) were found with MAA in situ.","['patients with obstructive sleep apnea', 'OSA patients with comorbid sleep bruxism', 'OSA patients', 'patients with obstructive sleep apnea (OSA', 'Eighteen patients with OSA (mean ± SD = 49.4 ± 9.8 years) with a mean ± SD apnea-hypopnea index (AHI) of 22.0 ± 16.0 events/hour of sleep participated']","['mandibular advancement appliance therapy', 'JCMA', 'mandibular advancement appliance (MAA) therapy', 'ambulatory polysomnographic recordings, one with an MAA in situ and another without the MAA']","['jaw-closing muscle activities time-related to respiratory arousals', 'jaw-closing muscle activity (JCMA) time-related to respiratory arousals, and on JCMA time-related to non-respiratory arousals', 'respiratory arousal index', 'JCMA time-related to respiratory arousal index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444498', 'cui_str': 'In situ'}]","[{'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",18.0,0.0219551,"RESULTS
Significant reductions in the AHI (Z = -2.984; P = 0.003), in the respiratory arousal index (Z = - 2.896; P = 0.004), and in the JCMA time-related to respiratory arousal index (Z = -3.434; P = 0.001) were found with MAA in situ.","[{'ForeName': 'Ghizlane', 'Initials': 'G', 'LastName': 'Aarab', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Arcache', 'Affiliation': 'Faculté de Médecine Dentaire, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Gilles J', 'Initials': 'GJ', 'LastName': 'Lavigne', 'Affiliation': 'Faculté de Médecine Dentaire, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lobbezoo', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Huynh', 'Affiliation': 'Faculté de Médecine Dentaire, Université de Montréal, Montréal, Canada.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8612']
2671,32501276,"Efficacy of Three Low-Intensity, Internet-Based Psychological Interventions for the Treatment of Depression in Primary Care: Randomized Controlled Trial.","BACKGROUND
Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches.
OBJECTIVE
This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]).
METHODS
A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months' follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages.
RESULTS
A moderate decrease was detected in PHQ-9 scores from HLP (β=-3.05; P=.01) and MP (β=-3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment.
CONCLUSIONS
The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions.
TRIAL REGISTRATION
ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1186/s12888-015-0475-0.",2020,"PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression.","['Depression in Primary Care', 'n=56), and MP (n=54', 'March 2015 and March 2016, with a follow-up of 12 months', 'patients with depression', '221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions']","['HLP', 'Three Low-Intensity, Internet-Based Psychological Interventions', 'PAPP intervention', 'iTAU', 'PAPP', '3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP', 'internet-based psychological interventions (HLP and MP']","['physical SF-12 scores', 'Spanish version of the Patient Health Questionnaire-9', 'PHQ-9 scores', 'visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0270456', 'cui_str': 'Moderate major depression'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0263420', 'cui_str': 'Hyperkeratosis lenticularis perstans'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0135262', 'cui_str': '1-(2-(4-aminophenyl)ethyl)-4-(3-trifluoromethylphenyl)piperazine'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",221.0,0.0776652,"PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression.","[{'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Adoración', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, Univeristy Jaume I, Castellón, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain.'}, {'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Mayoral-Cleries', 'Affiliation': 'Mental Heath Unit, Hospital Regional of Malaga, Biomedicine Research Institute (IBIMA), Málaga, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, Univeristy Jaume I, Castellón, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Barceló-Soler', 'Affiliation': 'Aragón Institute for Health Research (IIS Aragon), Zaragoza, Spain.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Hurtado', 'Affiliation': 'Mental Heath Unit, Hospital Regional of Malaga, Biomedicine Research Institute (IBIMA), Málaga, Spain.'}, {'ForeName': 'MªTeresa', 'Initials': 'M', 'LastName': 'Navarro', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Villena', 'Affiliation': 'Mental Health Unit of Pozoblaco, Hospital Los Pedroches, Córdoba, Spain.'}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Pérez-Ara', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Riera-Serra', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Rosa Mª', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Biomedical Research Center Network (CIBER) Physiopathology Obesity and Nutrition (CIBERobn), Carlos III Health Institute, Madrid, Spain.'}]",Journal of medical Internet research,['10.2196/15845']
2672,32501339,Senegal to trial $1 speedy test for covid-19.,,2020,,[],[],[],[],[],[],,0.0487405,,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Yeung', 'Affiliation': ''}]",New scientist (1971),['10.1016/S0262-4079(20)30914-3']
2673,32501528,"Filanesib in combination with pomalidomide and dexamethasone in refractory MM patients: safety and efficacy, and association with alpha 1-acid glycoprotein (AAG) levels. Phase Ib/II Pomdefil clinical trial conducted by the Spanish MM group.","This phase I/II trial evaluated the combination of the kinesin spindle protein inhibitor filanesib with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma (RRMM) patients. Forty-seven RRMM patients with a median of three prior lines (2-8) and 94% refractory to lenalidomide were included: 14 in phase I and 33 in phase II. The recommended dose was 1·25 mg/m 2 of filanesib on days 1, 2, 15, 16, with pomalidomide 4 mg on days 1-21 and dexamethasone 40 mg weekly. The defined threshold for success was achieved, with 18 out of 31 patients obtaining at least minor response (MR) in the phase II. In the global population, 51% of patients achieved at least partial response (PR) and 60% ≥MR, resulting in a median progression-free survival (mPFS) of seven months and overall survival (OS) of 19 months. The main toxicity was haematological. Importantly, patients with low serum levels of alpha 1-acid glycoprotein (AAG) at baseline (<800 mg/l) had a superior response (overall response rate of 62% vs. 17%; P = 0·04), which also translated into a longer mPFS (9 vs. 2 months; P = 0·014). In summary, filanesib with pomalidomide and dexamethasone is active in RRMM although with significant haematological toxicity. Most importantly, high levels of AAG can identify patients unlikely to respond to this strategy. Trial registration: clinicaltrials.gov identifier: NCT02384083.",2020,"Importantly, patients with low serum levels of alpha 1-acid glycoprotein (AAG) at baseline (<800 mg/l) had a superior response (overall response rate of 62% vs. 17%; P = 0·04), which also translated into a longer mPFS (9 vs. 2 months; P = 0·014).","['Forty-seven RRMM patients with a median of three prior lines (2-8) and 94% refractory to lenalidomide were included: 14 in phase', 'relapsed or refractory multiple myeloma (RRMM) patients', 'refractory MM patients']","['dexamethasone', 'Filanesib', 'pomalidomide and dexamethasone', 'pomalidomide 4 mg on days 1-21 and dexamethasone']","['median progression-free survival (mPFS) of seven months and overall survival (OS', 'haematological toxicity', 'low serum levels of alpha 1-acid glycoprotein (AAG', 'least partial response (PR']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4550884', 'cui_str': 'filanesib'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C3536053', 'cui_str': 'pomalidomide 4 MG [Pomalyst]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",31.0,0.0835996,"Importantly, patients with low serum levels of alpha 1-acid glycoprotein (AAG) at baseline (<800 mg/l) had a superior response (overall response rate of 62% vs. 17%; P = 0·04), which also translated into a longer mPFS (9 vs. 2 months; P = 0·014).","[{'ForeName': 'Enrique M', 'Initials': 'EM', 'LastName': 'Ocio', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Motlló', 'Affiliation': 'ICO Badalona, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodríguez-Otero', 'Affiliation': 'Clínica Universidad de Navarra, CIMA, IDISNA, CIBERONC, Pamplona, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Martínez-López', 'Affiliation': 'Hospital 12 de Octubre, Universidad Complutense, CNIO, Madrid, Spain.'}, {'ForeName': 'Mª José', 'Initials': 'MJ', 'LastName': 'Cejalvo', 'Affiliation': 'Hospital Universitario Doctor Peset. Departamento de Medicina Interna y Odontología, Universidad Católica de Valencia, Valencia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Martín-Sánchez', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bladé', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mª Dolores', 'Initials': 'MD', 'LastName': 'García-Malo', 'Affiliation': 'Hospital Morales Meseguer, IMIB-Arrixaca, Murcia, Spain.'}, {'ForeName': 'Mª Victoria', 'Initials': 'MV', 'LastName': 'Dourdil', 'Affiliation': 'Hospital Clínico Lozano Blesa, IIS Aragón, Zaragoza, Spain.'}, {'ForeName': 'Aránzazu', 'Initials': 'A', 'LastName': 'García-Mateo', 'Affiliation': 'Hospital General de Segovia, Segovia, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'de Arriba', 'Affiliation': 'Hospital Morales Meseguer, IMIB-Arrixaca, Murcia, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'García-Sanz', 'Affiliation': 'Complejo Asistencial Universitario de Salamanca (IBSAL) y Centro de Investigación del Cáncer (IBMCC-CSIC), Universidad de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Rubia', 'Affiliation': 'Hospital Universitario Doctor Peset. Departamento de Medicina Interna y Odontología, Universidad Católica de Valencia, Valencia, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Oriol', 'Affiliation': 'ICO Badalona, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Juan-José', 'Initials': 'JJ', 'LastName': 'Lahuerta', 'Affiliation': 'Hospital 12 de Octubre, Universidad Complutense, CNIO, Madrid, Spain.'}, {'ForeName': 'Jesús F', 'Initials': 'JF', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra, CIMA, IDISNA, CIBERONC, Pamplona, Spain.'}, {'ForeName': 'María-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Complejo Asistencial Universitario de Salamanca (IBSAL) y Centro de Investigación del Cáncer (IBMCC-CSIC), Universidad de Salamanca, Salamanca, Spain.'}]",British journal of haematology,['10.1111/bjh.16788']
2674,32501541,"Pharmacokinetics, safety and tolerability of long-acting parenteral intramuscular injection formulations of doravirine.","WHAT IS KNOWN AND OBJECTIVE
Doravirine is a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of human immunodeficiency virus (HIV)-1 infection. This phase 1 study in healthy adults investigated the pharmacokinetics, safety and tolerability of long-acting parenteral (LAP) microsuspension formulations of doravirine administered as an intramuscular (IM) injection.
METHODS
After confirmation of tolerability and safety of oral doravirine, 36 participants were randomized 1:1:1 to receive IM doravirine 200 mg as Treatment A (1 × 1 mL, 20% [200 mg/mL] suspension), B (1 × 0.66 mL, 30% [300 mg/mL] suspension) or C (2 × 0.5 mL, 20% suspension). Blood samples were taken as venous plasma, venous dried blood spots (DBS) and fingerstick DBS.
RESULTS AND DISCUSSION
Plasma concentration-time profiles following IM treatments demonstrated rapid initial doravirine release, with initial peak ~4 days post-injection, followed by decline over the next ~6 days; a second peak was reached at ~24-36 days, corresponding to prolonged and sustained release, with measurable concentrations up to Day 183. Treatment C was associated with highest peak concentrations and shortest time to maximum concentration. Elimination half-lives for all IM formulations were prolonged versus oral administration (~46-58 days vs ~11-15 hours). Oral doravirine and IM doravirine were generally well tolerated; injection-site pain was the most common adverse event for IM doravirine. Doravirine concentrations from DBS samples showed strong correlations to venous plasma concentrations.
WHAT IS NEW AND CONCLUSIONS
Novel doravirine LAP IM injection formulations investigated in this study demonstrated sustained plasma doravirine concentrations over a course of >20 weeks.",2020,Oral doravirine and IM doravirine were generally well tolerated; injection-site pain was the most common adverse event for IM doravirine.,"['36 participants', 'human immunodeficiency virus (HIV)-1 infection', 'healthy adults']","['IM doravirine 200\xa0mg as Treatment', 'doravirine', 'oral doravirine', 'Oral doravirine and IM doravirine']","['Pharmacokinetics, safety and tolerability', 'venous plasma, venous dried blood spots (DBS) and fingerstick DBS', 'tolerated; injection-site pain', 'pharmacokinetics, safety and tolerability', 'sustained plasma doravirine concentrations', 'rapid initial doravirine release']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3838734', 'cui_str': 'Venous plasma'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",36.0,0.0348717,Oral doravirine and IM doravirine were generally well tolerated; injection-site pain was the most common adverse event for IM doravirine.,"[{'ForeName': 'Ka Lai', 'Initials': 'KL', 'LastName': 'Yee', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Triantafyllou', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Marissa F', 'Initials': 'MF', 'LastName': 'Dockendorf', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Fackler', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Sauzanne G', 'Initials': 'SG', 'LastName': 'Khalilieh', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13182']
2675,32501595,Metformin monotherapy for adults with type 2 diabetes mellitus.,"BACKGROUND
Worldwide, there is an increasing incidence of type 2 diabetes mellitus (T2DM). Metformin is still the recommended first-line glucose-lowering drug for people with T2DM. Despite this, the effects of metformin on patient-important outcomes are still not clarified.
OBJECTIVES
To assess the effects of metformin monotherapy in adults with T2DM.
SEARCH METHODS
We based our search on a systematic report from the Agency for Healthcare Research and Quality, and topped-up the search in CENTRAL, MEDLINE, Embase, WHO ICTRP, and ClinicalTrials.gov. Additionally, we searched the reference lists of included trials and systematic reviews, as well as health technology assessment reports and medical agencies. The date of the last search for all databases was 2 December 2019, except Embase (searched up 28 April 2017).
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with at least one year's duration comparing metformin monotherapy with no intervention, behaviour changing interventions or other glucose-lowering drugs in adults with T2DM.
DATA COLLECTION AND ANALYSIS
Two review authors read all abstracts and full-text articles/records, assessed risk of bias, and extracted outcome data independently. We resolved discrepancies by involvement of a third review author. For meta-analyses we used a random-effects model with investigation of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall certainty of the evidence by using the GRADE instrument.
MAIN RESULTS
We included 18 RCTs with multiple study arms (N = 10,680). The percentage of participants finishing the trials was approximately 58% in all groups. Treatment duration ranged from one to 10.7 years. We judged no trials to be at low risk of bias on all 'Risk of bias' domains. The main outcomes of interest were all-cause mortality, serious adverse events (SAEs), health-related quality of life (HRQoL), cardiovascular mortality (CVM), non-fatal myocardial infarction (NFMI), non-fatal stroke (NFS), and end-stage renal disease (ESRD). Two trials compared metformin (N = 370) with insulin (N = 454). Neither trial reported on all-cause mortality, SAE, CVM, NFMI, NFS or ESRD. One trial provided information on HRQoL but did not show a substantial difference between the interventions. Seven trials compared metformin with sulphonylureas. Four trials reported on all-cause mortality: in three trials no participant died, and in the remaining trial 31/1454 participants (2.1%) in the metformin group died compared with 31/1441 participants (2.2%) in the sulphonylurea group (very low-certainty evidence). Three trials reported on SAE: in two trials no SAE occurred (186 participants); in the other trial 331/1454 participants (22.8%) in the metformin group experienced a SAE compared with 308/1441 participants (21.4%) in the sulphonylurea group (very low-certainty evidence). Two trials reported on CVM: in one trial no CVM was observed and in the other trial 4/1441 participants (0.3%) in the metformin group died of cardiovascular reasons compared with 8/1447 participants (0.6%) in the sulphonylurea group (very low-certainty evidence). Three trials reported on NFMI: in two trials no NFMI occurred, and in the other trial 21/1454 participants (1.4%) in the metformin group experienced a NFMI compared with 15/1441 participants (1.0%) in the sulphonylurea group (very low-certainty evidence). One trial reported no NFS occurred (very low-certainty evidence). No trial reported on HRQoL or ESRD. Seven trials compared metformin with thiazolidinediones (very low-certainty evidence for all outcomes). Five trials reported on all-cause mortality: in two trials no participant died; the overall RR was 0.88, 95% CI 0.55 to 1.39; P = 0.57; 5 trials; 4402 participants). Four trials reported on SAE, the RR was 0,95, 95% CI 0.84 to 1.09; P = 0.49; 3208 participants. Four trials reported on CVM, the RR was 0.71, 95% CI 0.21 to 2.39; P = 0.58; 3211 participants. Three trial reported on NFMI: in two trials no NFMI occurred and in one trial 21/1454 participants (1.4%) in the metformin group experienced a NFMI compared with 25/1456 participants (1.7%) in the thiazolidinedione group. One trial reported no NFS occurred. No trial reported on HRQoL or ESRD. Three trials compared metformin with dipeptidyl peptidase-4 inhibitors (one trial each with saxagliptin, sitagliptin, vildagliptin with altogether 1977 participants). There was no substantial difference between the interventions for all-cause mortality, SAE, CVM, NFMI and NFS (very low-certainty evidence for all outcomes). One trial compared metformin with a glucagon-like peptide-1 analogue (very low-certainty evidence for all reported outcomes). There was no substantial difference between the interventions for all-cause mortality, CVM, NFMI and NFS. One or more SAEs were reported in 16/268 (6.0%) of the participants allocated to metformin compared with 35/539 (6.5%) of the participants allocated to a glucagon-like peptide-1 analogue. HRQoL or ESRD were not reported. One trial compared metformin with meglitinide and two trials compared metformin with no intervention. No deaths or SAEs occurred (very low-certainty evidence) no other patient-important outcomes were reported. No trial compared metformin with placebo or a behaviour changing interventions. Four ongoing trials with 5824 participants are likely to report one or more of our outcomes of interest and are estimated to be completed between 2018 and 2024. Furthermore, 24 trials with 2369 participants are awaiting assessment.
AUTHORS' CONCLUSIONS
There is no clear evidence whether metformin monotherapy compared with no intervention, behaviour changing interventions or other glucose-lowering drugs influences patient-important outcomes.",2020,"There was no substantial difference between the interventions for all-cause mortality, SAE, CVM, NFMI and NFS (very low-certainty evidence for all outcomes).","['adults with type 2 diabetes mellitus', 'N = 370) with insulin (N = 454', '18 RCTs with multiple study arms (N = 10,680', 'people with T2DM', 'with altogether 1977 participants', '2369 participants are awaiting assessment', '5824 participants are likely to report one or more of our outcomes of interest and are estimated to be completed between 2018 and 2024', 'adults with T2DM']","['metformin monotherapy', 'Metformin', 'SAE', 'metformin with placebo', 'sulphonylurea', 'Metformin monotherapy', 'saxagliptin, sitagliptin, vildagliptin', 'glucagon-like peptide-1 analogue', 'metformin', 'CVM', 'thiazolidinedione', 'NFMI', 'metformin with dipeptidyl peptidase-4 inhibitors', 'metformin monotherapy with no intervention, behaviour changing interventions or other glucose-lowering drugs', 'metformin with thiazolidinediones']","['cause mortality, SAE, CVM, NFMI and NFS', 'HRQoL or ESRD', 'cause mortality, SAE, CVM, NFMI, NFS or ESRD', 'deaths or SAEs', 'died of cardiovascular reasons', 'CVM', 'NFMI', 'cause mortality, serious adverse events (SAEs), health-related quality of life (HRQoL), cardiovascular mortality (CVM), non-fatal myocardial infarction (NFMI), non-fatal stroke (NFS), and end-stage renal disease (ESRD', 'cause mortality', 'overall RR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0007872', 'cui_str': 'Cervical mucus'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007872', 'cui_str': 'Cervical mucus'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",370.0,0.173295,"There was no substantial difference between the interventions for all-cause mortality, SAE, CVM, NFMI and NFS (very low-certainty evidence for all outcomes).","[{'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Gnesin', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Department 7652, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anne Cathrine Baun', 'Initials': 'ACB', 'LastName': 'Thuesen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Lise Katrine Aronsen', 'Initials': 'LKA', 'LastName': 'Kähler', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Hemmingsen', 'Affiliation': 'Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012906.pub2']
2676,32501596,Effects of a person-centred approach in a school setting for adolescents with chronic pain - The HOPE randomized controlled trial.,"BACKGROUND
Chronic pain among adolescents is common but effective interventions applicable in a school setting are rare. Person-centred care (PCC) is a key factor in improving health by engaging people as partners in their own care.
METHODS
In this randomized controlled trial, a total of 98 adolescents in secondary school or upper secondary school (aged 14-21 years) with chronic pain were randomly assigned to a PCC intervention or standard school health care. In the intervention group a pain management program, based on a PCC approach, comprising four face-to-face sessions with a school nurse over a period of five weeks was added to standard school health care. The main outcome measure was self-efficacy in daily activities (SEDA scale) and rating scales for pain intensity and pain impact were used as secondary outcome measures.
RESULTS
At the follow-up, no significant differences were found between the groups in the SEDA scale (p=0.608) or in the rating scales for pain intensity (p=0.261) and pain impact (0.836). In the sub-group analysis, a significant improvement in the SEDA scale was detected at the secondary school in favour of the PCC intervention group (p=0.021).
CONCLUSION
In this pain management program based on a PCC approach, we found no effect in the total sample, but the program showed promising results to improve self-efficacy in daily activities among adolescents at secondary school.",2020,"At the follow-up, no significant differences were found between the groups in the SEDA scale (p=0.608) or in the rating scales for pain intensity (p=0.261) and pain impact (0.836).","['98 adolescents in secondary school or upper secondary school (aged 14-21 years) with chronic pain', 'adolescents at secondary school', 'adolescents with chronic pain ']","['Person-centred care (PCC', 'person-centred approach', 'PCC intervention or standard school health care']","['pain impact', 'rating scales for pain intensity', 'self-efficacy', 'self-efficacy in daily activities (SEDA scale) and rating scales for pain intensity and pain impact', 'SEDA scale']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036372', 'cui_str': 'Nursing, School'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",98.0,0.102401,"At the follow-up, no significant differences were found between the groups in the SEDA scale (p=0.608) or in the rating scales for pain intensity (p=0.261) and pain impact (0.836).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Box 457, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wallbing', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Box 457, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Gösta', 'Initials': 'G', 'LastName': 'Alfvén', 'Affiliation': 'Clintec, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Kemani', 'Affiliation': 'Department of Clinical Neuroscience (CNS), K8, Psychology, Karolinska Institutet, 171 77, Stockholm, Sweden.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Lundberg', 'Affiliation': 'University of Gothenburg, Centre for Person-Centred Care (GPCC), Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Wigert', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Box 457, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Nilsson', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Box 457, 405 30, Gothenburg, Sweden.'}]","European journal of pain (London, England)",['10.1002/ejp.1614']
2677,32501612,"Circulating Adhesion Molecules and Associations with HbA1c, Hypertension, Nephropathy, and Retinopathy in the Treatment Options for type 2 Diabetes in Adolescent and Youth (TODAY) Study.","BACKGROUND
The TODAY study, a randomized clinical trial of three treatments for type 2 diabetes (T2DM) in youth, demonstrated treatment failure (defined as sustained HbA1c ≥8%, or inability to wean insulin after 3 months after acute metabolic decomposition) in over half of the participants. Given that binding of mononuclear cells to vascular endothelium, initiated by cellular adhesion molecules and chemokines, is an early step in vascular injury, we sought to evaluate 1) changes in cellular adhesion molecule levels during the trial, 2) effect of diabetes treatment, and 3) association of markers with HbA1c, hypertension, hypercholesterolemia, nephropathy, and retinopathy.
METHODS
Participants (n = 515 of 699) that had baseline assessment of adhesion molecules (MCP-1, VCAM, ICAM, and E-Selectin) and at least one other assessment, measured at month 12, 24, or 36, were included.
RESULTS
Over 1-3 years, significant increases in MCP-1 and decreases in VCAM (both P < 0.0001) concentrations were found; however, no significant interactions were identified with treatment group for any molecule. For every 1% increase in HbA1c, ICAM increased by 1.8%, VCAM by 1.5%, and E-selectin by 6.8% (all P < 0.0001). E-selectin increased by 3.7% and 4.2% for every 10 mmHg increase in systolic and diastolic blood pressure, respectively (both P < 0.0001). ICAM was 10.2% higher and E-selectin 15.5% higher in participants with microalbuminuria (both P < 0.01). There was no significant association of adhesion molecule levels with retinopathy.
CONCLUSION
Concentrations of cellular adhesion molecules rise with increasing HbA1c in youth with T2DM, and are associated with blood pressure and microalbuminuria, markers of vascular injury. This article is protected by copyright. All rights reserved.",2020,ICAM was 10.2% higher and E-selectin 15.5% higher in participants with microalbuminuria (both P < 0.01).,"['type 2 diabetes (T2DM) in youth, demonstrated treatment failure (defined as sustained HbA1c ≥8%, or inability to wean insulin after 3\u2009months after acute metabolic decomposition) in over half of the participants', 'Participants (n\xa0']",[],"['E-selectin', 'adhesion molecules (MCP-1, VCAM, ICAM, and E-Selectin', 'systolic and diastolic blood pressure', 'HbA1c, ICAM', 'ICAM', 'MCP-1 and decreases in VCAM ']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",[],"[{'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",2.0,0.0525065,ICAM was 10.2% higher and E-selectin 15.5% higher in participants with microalbuminuria (both P < 0.01).,"[{'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Rachana D', 'Initials': 'RD', 'LastName': 'Shah', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Braffett', 'Affiliation': 'The Biostatistics Center, George Washington University, Rockville, Maryland.'}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, California.'}, {'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Gubitosi-Klug', 'Affiliation': 'Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital and the University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital and the University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.13062']
2678,32501613,The causal pathway effects of a physical activity intervention on adiposity in children: The KISS Study cluster randomised clinical trial.,"BACKGROUND
Very little information on the potential mechanisms of the physical activity interventions effects on adiposity is available. We evaluated the possible mediating factors of a physical activity school-based intervention on the sum of skinfolds in children.
METHODS
This is a cluster randomised trial, secondary analysis of the KISS study. Children (n=499) from the first and fifth grades were randomly assigned to intervention or control group. Adiposity was estimated by four skinfolds, aerobic fitness assessed by the shuttle run test, and insulin, triglycerides, total cholesterol, high-density lipoprotein (HDL) and glucose collected via fasting blood samples.
RESULTS
The intervention affected aerobic fitness (0.140 SD, 95%CI 0.011 to 0.270), triglycerides (0.217 SD, 95%CI -0.409 to -0.025), cholesterol/HDL ratio (-0.191 SD, 95%CI -0.334 to -0.047), glucose (-0.330 SD, 95%CI -0.538 to -0.121) and skinfolds (-0.122 SD, 95%CI -0.189 to -0.056). No intervention effect on insulin was found. We observed that changes in aerobic fitness impacted children's triglycerides and cholesterol/HDL ratio and consecutively the glucose levels mediating 30% of the intervention effect on skinfolds.
CONCLUSIONS
Our findings provided evidence of the positive metabolic distress caused by a physical activity intervention on adiposity levels in children.",2020,"The intervention affected aerobic fitness (0.140 SD, 95%CI 0.011 to 0.270), triglycerides (0.217 SD, 95%CI -0.409 to -0.025), cholesterol/HDL ratio (-0.191 SD, 95%CI -0.334 to -0.047), glucose (-0.330 SD, 95%CI -0.538 to -0.121) and skinfolds (-0.122 SD, 95%CI -0.189 to -0.056).","['Children (n=499) from the first and fifth grades', 'children']","['physical activity intervention', 'physical activity school-based intervention']","['aerobic fitness', 'aerobic fitness assessed by the shuttle run test, and insulin, triglycerides, total cholesterol, high-density lipoprotein (HDL) and glucose collected via fasting blood samples', 'Adiposity', 'triglycerides', 'adiposity levels', ""aerobic fitness impacted children's triglycerides and cholesterol/HDL ratio"", 'cholesterol/HDL ratio']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.117116,"The intervention affected aerobic fitness (0.140 SD, 95%CI 0.011 to 0.270), triglycerides (0.217 SD, 95%CI -0.409 to -0.025), cholesterol/HDL ratio (-0.191 SD, 95%CI -0.334 to -0.047), glucose (-0.330 SD, 95%CI -0.538 to -0.121) and skinfolds (-0.122 SD, 95%CI -0.189 to -0.056).","[{'ForeName': 'Rodrigo Antunes', 'Initials': 'RA', 'LastName': 'Lima', 'Affiliation': 'Institute of Sports Science, University of Graz, Graz, Austria.'}, {'ForeName': 'Lars Bo', 'Initials': 'LB', 'LastName': 'Andersen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Fernanda Cunha', 'Initials': 'FC', 'LastName': 'Soares', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Susi', 'Initials': 'S', 'LastName': 'Kriemler', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13741']
2679,32496736,Exercise Training Impacts Skeletal Muscle Clock in Adults with Prediabetes.,"PURPOSE
Disruption of the skeletal muscle molecular clock leads to metabolic disease, while exercise may be restorative, leading to improvements in metabolic health. The purpose of this study was to evaluate the effects of a 12-week exercise intervention on skeletal muscle molecular clock machinery in adults with obesity and prediabetes, and determine whether these changes were related to exercise-induced improvements in metabolic health.
METHODS
Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week exercise intervention and were fully provided isoenergetic diets. Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy) were assessed at baseline and after intervention. Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER 1/2 were measured by quantitative real-time PCR and Western blot, respectively.
RESULTS
Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max) all improved (P<0.005) with exercise training. Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged. The fold change in BMAL1 correlated with post GDR (r=0.43, P=0.044), BMI (r=-0.44, P=0.042), and body weight changes (r=-0.44, P=0.039) expressed as percent delta.
CONCLUSION
Exercise training impacts skeletal muscle molecular clock machinery in a clinically-relevant cohort of adults with obesity and prediabetes. Skeletal muscle BMAL1 gene expression may improve insulin sensitivity. Future studies are needed to determine the physiological significance of exercise-induced alterations in skeletal muscle clock machinery.",2020,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","['Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week', 'adults with obesity and prediabetes', 'Adults with Prediabetes']","['exercise intervention', 'Exercise training', 'Exercise Training', 'exercise intervention and were fully provided isoenergetic diets']","['Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy', 'Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max', 'Skeletal muscle BMAL1 gene', 'PER2 protein expression', 'BMAL1', 'BMI', 'while CLOCK, CRY1/2 and PER1', 'Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER', 'body weight changes']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0337076', 'cui_str': 'Industrial machine'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",26.0,0.0285188,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002368']
2680,32496814,Assessing an evidence-based intervention for spouse caregivers of persons with Alzheimer's disease: results of a community implementation of the NYUCI in Israel.,"Objectives: Alzheimer's disease (AD) affects not only the person with the illness, but family caregivers as well. The NYU Caregiver Intervention (NYUCI), a psychosocial intervention which has demonstrated both short and long-term benefits for caregivers, has been used widely in the United States and in Australia and England. The Israeli study was a hybrid between a community implementation study and a randomized controlled trial (RCT) of the NYUCI in a non-English speaking country. Method: A sample of 100 spouse caregivers participated in trial comparing the NYUCI provided by ten Israeli clinicians (enhanced care), to support group participation (usual care). The major outcome of interest was caregiver depressive symptoms, measured with the Geriatric Depression Scale. A linear random effects regression model controlling for factors associated with depressive symptoms was used to plot the longitudinal trajectories of depressive symptoms over the two-year study period and compare outcomes for the enhanced care and control groups. Results : One hundred spouse caregivers enrolled, of whom 81 provided data at baseline and at one or more post intervention assessments. The Israeli adaptation of the NYUCI was effective in reducing depressive symptoms reported by caregivers compared to their counterparts in the control group, b= -1.29 [95%CI (-2.43, -0.15)], p = .0265. Conclusion: While implementing a randomized controlled trial of an intervention developed and tested in traditional research settings using community providers in Israel, posed unique challenges, the study demonstrated benefits to caregivers. As a result, 30 municipalities in Israel are currently implementing an ongoing adaptation of the NYUCI.",2020,"The Israeli adaptation of the NYUCI was effective in reducing depressive symptoms reported by caregivers compared to their counterparts in the control group, b=","['100 spouse caregivers participated in trial comparing the NYUCI provided by ten Israeli clinicians (enhanced care), to support group participation (usual care', ""spouse caregivers of persons with Alzheimer's disease"", 'in a non-English speaking country', 'One hundred spouse caregivers enrolled, of whom 81 provided data at baseline and at one or more post intervention assessments', ""Alzheimer's disease (AD""]",['NYUCI'],"['caregiver depressive symptoms, measured with the Geriatric Depression Scale', 'depressive symptoms']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0087015', 'cui_str': 'Spouse Caregivers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",100.0,0.0833149,"The Israeli adaptation of the NYUCI was effective in reducing depressive symptoms reported by caregivers compared to their counterparts in the control group, b=","[{'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Werner', 'Affiliation': 'Department of Community Mental Health, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Olivio J', 'Initials': 'OJ', 'LastName': 'Clay', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Dovrat', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Department of Community Mental Health, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Ile', 'Initials': 'I', 'LastName': 'Kermel-Schifmann', 'Affiliation': 'Department of Community Mental Health, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Michal Karen', 'Initials': 'MK', 'LastName': 'Herz', 'Affiliation': 'Association for Dementia Studies, University of Worcester, Worcester, UK.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Epstein', 'Affiliation': 'Department of Psychiatry, NYU School of Medicine, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Mittelman', 'Affiliation': 'Department of Psychiatry, NYU School of Medicine, NYU Langone Health, New York, NY, USA.'}]",Aging & mental health,['10.1080/13607863.2020.1774740']
2681,32496821,A test of a resilience based intervention for mental health problems in Iraqi internally displaced person camps.,"Background and Objectives: The mental health needs of those in internally displaced persons camps are significant and are compounded by a number of barriers to care. Traditional methods of mental health care are often not feasible and thus a need exists for interventions that can successfully meet these conditions. The current study introduces and tests a new positive-psychology intervention, GROW, which was designed specifically for use in internally displaced persons camps. Design: Pre-Post-Follow-up longitudinal examination of those who participated in the GROW intervention group ( N = 766). Methods: The study includes three waves of data for the intervention, which was administered in a group format, using paraprofessionals, over a two-week period in internally displaced persons camps in Iraq. Results: The results indicate significant decreases in symptoms of PTSD for participants from pre- to post-intervention and demonstrates these changes were maintained at a three-month follow-up. Post hoc results indicated participants who were older, female, or who attended more sessions were more likely to respond to the intervention. Conclusions: These data provide initial support for the intervention and suggest additional research to more fully validate this intervention are warranted.",2020,The results indicate significant decreases in symptoms of PTSD for participants from pre- to post-intervention and demonstrates these changes were maintained at a three-month follow-up.,['mental health problems in Iraqi internally displaced person camps'],['GROW intervention'],['symptoms of PTSD'],"[{'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C1556087', 'cui_str': 'Iraqi'}, {'cui': 'C5197839', 'cui_str': 'Internally Displaced Persons'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",,0.0256564,The results indicate significant decreases in symptoms of PTSD for participants from pre- to post-intervention and demonstrates these changes were maintained at a three-month follow-up.,"[{'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Lancaster', 'Affiliation': 'Department of Psychology, Bethel University, St Paul, MN.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Gaede', 'Affiliation': 'Tutapona, New Richmond, WI.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1773446']
2682,32496835,Does person-centred care improve outcomes for musicians fitted with hearing protectors?,"Objective: To reduce the risk of hearing injury, musicians are often recommended custom-made musicians' hearing protectors (MHP). Studies report benefits of use however, many still report challenges leading to relatively low uptake and inconsistent usage. Person-centred approaches to health have been shown to improve patient outcomes, and these principles may be translatable to musicians' hearing care. The aim was to investigate if use of, and satisfaction with, MHP is influenced by the treatment delivered to musicians by audiologists. Design: Participants were randomly allocated to one of four conditions that varied in extent of person-centred care. Study sample: Forty-two musicians with an interest in purchasing MHP were recruited. Results: Satisfaction with MHP was high overall and users reported a reduction in incidence of tinnitus. Participants reported few issues related to sound quality, however insertion difficulty was the main problem reported. Only one musician self-identified the need for alterations to their MHP. Conclusions: Adoption of person-centred approaches to MHP was not found to increase likelihood of use, however, satisfaction was high across all conditions. Most often, the need for MHP alterations were clinician-identified during fitting appointments or follow-up contact, underscoring the importance of including these components when providing audiological services to musicians.",2020,"Conclusions: Adoption of person-centred approaches to MHP was not found to increase likelihood of use, however, satisfaction was high across all conditions.",['Study sample: Forty-two musicians with an interest in purchasing MHP were recruited'],['MHP'],['incidence of tinnitus'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]",42.0,0.0491183,"Conclusions: Adoption of person-centred approaches to MHP was not found to increase likelihood of use, however, satisfaction was high across all conditions.","[{'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'McGinnity', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Elizabeth Francis', 'Initials': 'EF', 'LastName': 'Beach', 'Affiliation': 'The HEARing Cooperative Research Centre, Melbourne, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cowan', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Mulder', 'Affiliation': 'The HEARing Cooperative Research Centre, Melbourne, Australia.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Barr', 'Affiliation': 'Department of Audiology & Speech Pathology, The University of Melbourne, Melbourne, Australia.'}]",International journal of audiology,['10.1080/14992027.2020.1771621']
2683,32496865,Socioecological determinants of community resource utilisation among low-income women in Mexico City who experienced male-to-female intimate partner violence.,"Women who experience intimate partner violence (IPV) face multiple barriers to seeking help from community resources, but little research has examined the impact of ecological influences on community resource utilisation among women living in low- and middle-income countries. The current study investigated individual-, relationship-, family-, and community-level influences on community resource utilisation among Mexican women experiencing IPV. Using baseline data from 950 women in Mexico City enrolled in a clinic-based randomised controlled trial, multilevel regressions were performed to assess associations between socioecological factors and women's community resource utilisation. 41.3% women used at least one resource. At the individual-level, every additional resource that women were aware of, was associated with a 20% increase in the total number of resources used ( p < .001). Every additional lethal risk factor was associated with a 5% increase in the total number of resources used ( p = .004). At the family-level, women who reported having an in-law encourage IPV used 46% more resources ( p < .001). At the community-level, stronger supportive norms around community resource utilisation was associated with a 6% increase in the total number of resources ( p = .01). These findings suggest the importance of addressing family and community factors in the broader ecological context of Mexican women's help-seeking behaviours.",2020,Every additional lethal risk factor was associated with a 5% increase in the total number of resources used ( p = .004).,"['low-income women in Mexico City who experienced male-to-female intimate partner violence', 'Mexican women experiencing IPV', 'Women who experience intimate partner violence (IPV', '950 women in Mexico City enrolled in a clinic', 'women living in low- and middle-income countries']",[],"['total number of resources', 'total number of resources used']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",950.0,0.0384717,Every additional lethal risk factor was associated with a 5% increase in the total number of resources used ( p = .004).,"[{'ForeName': 'Tiara C', 'Initials': 'TC', 'LastName': 'Willie', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bastida', 'Affiliation': 'Department of Psychiatry, University of California, Davis, CA, USA.'}, {'ForeName': 'Claudia Diaz', 'Initials': 'CD', 'LastName': 'Olavarrieta', 'Affiliation': 'Research Division, Faculty of Medicine, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Scolese', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Paola Abril', 'Initials': 'PA', 'LastName': 'Campos', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Falb', 'Affiliation': 'International Rescue Committee, Washington, DC, USA.'}, {'ForeName': 'Jhumka', 'Initials': 'J', 'LastName': 'Gupta', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, VA, USA.'}]",Global public health,['10.1080/17441692.2020.1775868']
2684,32496884,Uterine electromyography (EMG) measurements to predict preterm caesarean section in patients with complete placenta previa.,"The objective of the study was to evaluate uterine electrical activity (EA) with EMG methods in pregnant women with complete placenta previa with preterm caesarean section (CS). This prospective study included 78 patients with complete placenta previa who were recorded for uterine EA activity from 32 to 34 weeks of gestation. The clinical and the uterine EMG burst characteristics, that are responsible for contractions, were compared between a preterm CS group (case group, n = 33) and an elective control group (control group, n = 45). The uterine EA burst duration was longer in the case group compared with the control group (28.79 ± 3.75 vs 19.35 ± 2.56 s; p < .001). Also, the number of burst per 30 min was also higher in the case group compared with the control group (3.28 ± 0.18 vs 1.72 ± 0.22; p < .001), Similarly, the RMS was higher in the case group compared with the control group (0.07 ± 0.01 vs 0.04 ± 0.01 mV; p = .041). In addition, the PDS was higher in the case group compared with the control group (0.47 ± 0.03 vs 0.39 ± 0.02 Hz; p = .023). This study demonstrates that women with complete placenta previa have higher uterine EA at 32-34 weeks of gestation and this is associated with a higher risk of preterm CS due to massive vaginal bleeding.IMPACT STATEMENT What is already known on this subject? Antepartum massive bleeding in complete placenta previa causes maternal and foetal mortality and morbidity, currently there is no effective method to predict it. What do the results of this study add? This study showed in patients with complete placenta previa who were delivered preterm via emergent caesarean section, the uterine electrical activity measured by uterine electromyography (EMG) at 32-34 weeks of gestation had an active pattern What are the implications of these findings for clinical practice and/or further research? Uterine EMG is a potential tool to measure uterine electrical activity and can guide clinical management of patients with complete placenta previa, further study are needed to confirm its effectiveness in a large sample size.",2020,"Uterine EMG is a potential tool to measure uterine electrical activity and can guide clinical management of patients with complete placenta previa, further study are needed to confirm its effectiveness in a large sample size.","['patients with complete placenta previa who were delivered preterm via emergent caesarean section, the', 'pregnant women with complete placenta previa with preterm caesarean section (CS', '78 patients with complete placenta previa who were recorded for uterine EA activity from 32 to 34\u2009weeks of gestation', 'women with complete placenta previa', 'patients with complete placenta previa']","['Uterine electromyography (EMG) measurements', 'IMPACT', 'uterine electrical activity measured by uterine electromyography (EMG']","['uterine electrical activity (EA', 'PDS', 'RMS', 'uterine EA burst duration', 'number of burst per 30\u2009min']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266763', 'cui_str': 'Placenta previa centralis'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]",78.0,0.173946,"Uterine EMG is a potential tool to measure uterine electrical activity and can guide clinical management of patients with complete placenta previa, further study are needed to confirm its effectiveness in a large sample size.","[{'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Xiuyu', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': ""Department of Obstetrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Garfield', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Arizona College of Medicine Phoenix, Phoenix, AZ, USA.'}, {'ForeName': 'Huishu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'First Affiliated Hospital of Jinan University, Guangzhou, China.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2020.1755620']
2685,32496886,Influence of virtual keyboard design and usage posture on typing performance and muscle activity during tablet interaction.,"This study aimed to determine the effects of virtual keyboard designs and postures on task performance and muscle activity during tablet use. Eighteen healthy adults were randomly assigned to one of three postures (DESK, LAP, BED) to complete six sessions of 60-minute typing on a tablet with three virtual keyboards (STD, WIDE, SPLIT) twice in an experimental laboratory. Keystroke dynamics and muscle activity of the forearm and neck-shoulder regions were measured by electromyography. The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD, p = 0.015; SPLIT vs WIDE, p < 0.001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD, p = 0.021). Lap posture was associated with faster typing speed (p = 0.018) and higher forearm muscle activity (p < 0.05). Typing performance decreased (p < 0.001) with elevated neck extensor muscle activity (p = 0.042) when the task duration prolonged. The split virtual keyboard showed potential to improve tablet ergonomics under various postures. Practitioner summary: Tablets have become widely used for a variety of tasks and have gradually expanded into the realm of mobile productivity and education. Adequate designs of virtual keyboards for tablets show the potential for increased task performance and decreased muscle activity pertinent to typing activity and posture constraints imposed by non-traditional work positions.",2020,"The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD, p = 0.015; SPLIT vs WIDE, p < 0.001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD, p = 0.021).",['Eighteen healthy adults'],"['virtual keyboard design and usage posture', 'virtual keyboard designs and postures']","['Typing performance', 'elevated neck extensor muscle activity', 'muscle activity of extensor digitorum communis', 'task performance and muscle activity', 'Keystroke dynamics and muscle activity of the forearm and neck-shoulder regions', 'forearm muscle activity']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224268', 'cui_str': 'Structure of extensor digitorum muscle of hand'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1760774', 'cui_str': 'Structure of muscle of forearm'}]",18.0,0.0249073,"The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD, p = 0.015; SPLIT vs WIDE, p < 0.001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD, p = 0.021).","[{'ForeName': 'Ming-I Brandon', 'Initials': 'MB', 'LastName': 'Lin', 'Affiliation': 'Department of industrial and information management, National Cheng-Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ruei-Hong', 'Initials': 'RH', 'LastName': 'Hong', 'Affiliation': 'Institute of information management, National Cheng-Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Huang', 'Affiliation': 'Department of industrial and information management, National Cheng-Kung University, Tainan, Taiwan.'}]",Ergonomics,['10.1080/00140139.2020.1778097']
2686,32496892,Effects of A Benefit-Finding Intervention in Stroke Caregivers in Communities.,"OBJECTIVES
To verify the effectiveness and feasibility of a nine-week benefit-finding intervention on the burden, quality of life, and benefit finding of caregivers, as well as on the quality of life of stroke survivors.
METHODS
Benefit finding refers to the individual, social, psychological and spiritual benefits perceived by an individual experiencing stress or post-traumatic events. A randomized controlled trial was performed in which 68 stroke survivors and their caregivers were recruited from the Zhengzhou community, China, and randomly split into two groups. The intervention group included those having undergone a nine-week benefit-finding intervention, while the control group included those individuals having undergone a nine-week routine health education. At baseline and one-week post-intervention (after a 9-week intervention), the quality of life of stroke survivors and caregivers and the burden and benefit finding of caregivers were determined.
RESULTS
In comparison to the control group, caregiver benefit finding, quality of life, burden, and stroke survivor quality of life were significantly improved ( P <.005).
CONCLUSIONS
The intervention appears to be feasible for stroke patients and caregivers. The intervention is capable of improving the quality of life of caregivers and survivors, increasing the benefit finding of caregivers and reducing the burden of caregivers.
CLINICAL IMPLICATIONS
The benefit-finding intervention is capable of improving the health condition of stroke patients and caregivers.",2020,"In comparison to the control group, caregiver benefit finding, quality of life, burden, and stroke survivor quality of life were significantly improved (","['Stroke Caregivers in Communities', '68 stroke survivors and their caregivers were recruited from the Zhengzhou community, China, and randomly split into two groups']","['having undergone a nine-week benefit-finding intervention, while the control group included those individuals having undergone a nine-week routine health education', 'Benefit-Finding Intervention']","['quality of life of stroke survivors and caregivers and the burden and benefit finding of caregivers', 'caregiver benefit finding, quality of life, burden, and stroke survivor quality of life', 'burden, quality of life']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",,0.0544393,"In comparison to the control group, caregiver benefit finding, quality of life, burden, and stroke survivor quality of life were significantly improved (","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'School of Nursing and Health, Zhengzhou University , Zhengzhou, China.'}, {'ForeName': 'Yongxia', 'Initials': 'Y', 'LastName': 'Mei', 'Affiliation': 'School of Nursing and Health, Zhengzhou University , Zhengzhou, China.'}, {'ForeName': 'Beilei', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'School of Nursing and Health, Zhengzhou University , Zhengzhou, China.'}, {'ForeName': 'Yawen', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'School of Nursing and Health, Zhengzhou University , Zhengzhou, China.'}, {'ForeName': 'Zhenxiang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing and Health, Zhengzhou University , Zhengzhou, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Qi', 'Affiliation': 'School of Nursing and Health, Zhengzhou University , Zhengzhou, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Nursing and Health, Zhengzhou University , Zhengzhou, China.'}]",Clinical gerontologist,['10.1080/07317115.2020.1765062']
2687,32496902,Impact of Intrathecal Triple Therapy Versus Intrathecal Methotrexate on Disease-Free Survival for High-Risk B-Lymphoblastic Leukemia: Children's Oncology Group Study AALL1131.,"PURPOSE
The high-risk stratum of Children's Oncology Group Study AALL1131 was designed to test the hypothesis that postinduction CNS prophylaxis with intrathecal triple therapy (ITT) including methotrexate, hydrocortisone, and cytarabine would improve the postinduction 5-year disease-free survival (DFS) compared with intrathecal methotrexate (IT MTX), when given on a modified augmented Berlin-Frankfurt-Münster backbone.
PATIENTS AND METHODS
Children with newly diagnosed National Cancer Institute (NCI) high-risk B-cell acute lymphoblastic leukemia (HR B-ALL) or NCI standard-risk B-ALL with defined minimal residual disease thresholds during induction were randomly assigned to receive postinduction IT MTX or ITT. Patients with CNS3-status disease were not eligible. Postinduction IT therapy was given for a total of 21 to 26 doses. Neurocognitive assessments were performed during therapy and during 1 year off therapy.
RESULTS
Random assignment was closed to accrual in March 2018 after a futility boundary had been crossed, concluding that ITT could not be shown to be superior to IT MTX. The 5-year postinduction DFS and overall survival rates (± SE) of children randomly assigned to IT MTX versus ITT were 93.2% ± 2.1% v 90.6% ± 2.3% ( P = .85), and 96.3% ± 1.5% v 96.7% ± 1.4% ( P = .77), respectively. There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities observed for patients receiving IT MTX compared with ITT. There were no significant differences in neurocognitive outcomes for patients receiving IT MTX compared with ITT.
CONCLUSION
Postinduction CNS prophylaxis with ITT did not improve 5-year DFS for children with HR B-ALL. The standard of care for CNS prophylaxis for children with B-ALL and no overt CNS involvement remains IT MTX.",2020,"There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities observed for patients receiving IT MTX compared with ITT.","['children with B-ALL and no overt CNS involvement remains IT MTX', 'Patients with CNS3-status disease', 'Children with newly diagnosed National Cancer Institute (NCI) high-risk B-cell acute lymphoblastic leukemia (HR B-ALL) or NCI standard-risk B-ALL with defined minimal residual disease thresholds during induction']","['Intrathecal Methotrexate', 'postinduction IT MTX or ITT', 'IT MTX', 'Intrathecal Triple Therapy', 'intrathecal triple therapy (ITT) including methotrexate, hydrocortisone, and cytarabine', 'intrathecal methotrexate (IT MTX']","['cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities', 'neurocognitive outcomes', '5-year DFS', 'postinduction 5-year disease-free survival (DFS', '5-year postinduction DFS and overall survival rates (± SE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0686377', 'cui_str': 'Secondary malignant neoplasm of central nervous system'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0503645,"There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse rates, or in toxicities observed for patients receiving IT MTX compared with ITT.","[{'ForeName': 'Wanda L', 'Initials': 'WL', 'LastName': 'Salzer', 'Affiliation': 'Uniformed Services University, Bethesda, MD.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Burke', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Kristina K', 'Initials': 'KK', 'LastName': 'Hardy', 'Affiliation': ""Children's National Medical Center, Washington, DC.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kairalla', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Gore', 'Affiliation': ""Department of Pediatrics, Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Hilden', 'Affiliation': ""Department of Pediatrics, Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': ""Department of Pediatrics, Maine Children's Cancer Program, Scarborough, ME.""}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Rabin', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Zweidler-McKay', 'Affiliation': 'ImmunoGen, Inc, Waltham, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Wood', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, The Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02892']
2688,32496907,Effects of dexamethasone on foetal Doppler flow velocimetry.,"Corticosteroid administration before anticipated preterm birth is a well known antenatal therapy available to improve newborn outcomes. Doppler studies of maternal and foetal vessels provide a way to understand how corticosteroid affects and improves foetal respiratory outcome. This study was registered on 8th of October, 2017 by Menoufia Faculty of Medicine Board with registration number 222-2-10-2017. It included 80 pregnant women divided into two groups. Each group consisted of 40 participants. Group A: participants were between 28 weeks and 34 weeks of gestation and were at risk of preterm labour. Group B: participants were those who had undergone an elective caesarean section (CS) before completing the 39th week of gestation. Each woman had received four doses of Dexamethasone 6 mg intramuscularly, 12 h apart. Doppler studies were performed before the Dexamethasone adminstration and 24 h after the Dexamethasone course. Among both groups, only pregnant women before 34 weeks of gestation showed a significant decrease in middle cerebral artery pulsatility index. However, the other Doppler parameters showed no significant effect. In conclusion, Dexamethasone administration affected only the middle cerebral artery pulsatility index before 34 weeks of gestation.IMPACT STATEMENT What is already known on this subject? Preterm births account for 75% of neonatal morbidity and pulmonary dysfunction plays an important role on such morbidities. Also, neonates born after an elective CS have significantly higher rates of respiratory morbidity and neonatal intensive care unit admission. Corticosteroids are wildly used to improve neonatal outcome in women who have expected preterm labour and before an elective CS. What do the results of this study add? Dexamethasone affected blood distribution of foetal brain only before 34 weeks of gestation that had been proved by changes of foetal middle cerebral artery pulsatility index without affecting other Doppler parameters of both groups. With the improvement of foetal respiratory outcome in both groups. What are the implications of these finding for clinical practice and/or further research? Maternal Dexamethasone injection is recommended for mothers at risk of preterm labour, especially if delivery is expected within six days and mothers who will undergo elective CS before completion of 39 weeks of gestation, in terms of improving neonatal respiratory functions and decreasing the possibility of admission to neonatal intensive care unit for transient tachypnoea of the newborn.",2020,"Among both groups, only pregnant women before 34 weeks of gestation showed a significant decrease in middle cerebral artery pulsatility index.","['80 pregnant women divided into two groups', 'mothers at risk of preterm labour', 'participants were those who had undergone an elective caesarean section (CS) before completing the 39th week of gestation', 'registered on 8th of October, 2017 by Menoufia Faculty of Medicine Board with registration number 222-2-10-2017', 'women who have expected preterm labour and before an elective CS']","['Corticosteroid', 'dexamethasone', 'Corticosteroids', 'Dexamethasone', 'IMPACT', 'Maternal Dexamethasone injection']","['foetal middle cerebral artery pulsatility index', 'blood distribution of foetal brain', 'middle cerebral artery pulsatility index', 'foetal respiratory outcome', 'foetal Doppler flow velocimetry', 'respiratory morbidity and neonatal intensive care unit admission']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4283889', 'cui_str': 'Dexamethasone Injection'}]","[{'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0440731', 'cui_str': 'Fetal brain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0162462', 'cui_str': 'Velocimetry'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",80.0,0.205819,"Among both groups, only pregnant women before 34 weeks of gestation showed a significant decrease in middle cerebral artery pulsatility index.","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Nofal', 'Affiliation': 'Obstetrics and Gynacology Department, Faculty of Medicine, Menoufia University, Shebin El-Kom, Egypt.'}, {'ForeName': 'Tarek M', 'Initials': 'TM', 'LastName': 'Sayyed', 'Affiliation': 'Obstetrics and Gynacology Department, Faculty of Medicine, Menoufia University, Shebin El-Kom, Egypt.'}, {'ForeName': 'Hesham S', 'Initials': 'HS', 'LastName': 'Mahmoud', 'Affiliation': 'Obstetrics and Gynacology Department, Faculty of Medicine, Menoufia University, Shebin El-Kom, Egypt.'}, {'ForeName': 'Tamer Y', 'Initials': 'TY', 'LastName': 'Atia', 'Affiliation': 'Obstetrics and Gynacology Department, Menouf General Hospital, Shebin El-Kom, Egypt.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2020.1742677']
2689,32496921,Neurocognitive effects of atypical antipsychotics in patients with first-episode schizophrenia.,"Introduction: Cognitive impairment is a core feature of schizophrenia. The effects of atypical antipsychotics on the cognitive functions of patients with first-episode schizophrenia have not been comprehensively investigated so far. This study aims to compare neurocognitive effects of risperidone, olanzapine, and aripiprazole for first-episode schizophrenia. Methods: The study was a multicenter, randomized, open-label clinical trial. 546 patients were randomly divided into three medication groups, and followed up for 1 year. Cognitive performance was evaluated with a neuropsychological test battery. The Clinical trials.gov ID of the study is NCT01057849. Results: At 6 months, treatment resulted in significant improvements in all three groups in most cognitive domains except verbal learning and memory. At 12 months, three treatment groups had further improvements in three cognitive domains, but visual learning and memory performance dropped back to baseline. Conclusion: All three atypical antipsychotics tested in the study can potentially improve cognitive performance in first-episode schizophrenia, but no significant difference in the degree of improvement was found between drugs.",2020,"At 12 months, three treatment groups had further improvements in three cognitive domains, but visual learning and memory performance dropped back to baseline.","['first-episode schizophrenia', 'patients with first-episode schizophrenia', '546 patients']","['atypical antipsychotics', 'risperidone, olanzapine, and aripiprazole']","['cognitive domains except verbal learning and memory', 'cognitive performance', 'three cognitive domains, but visual learning and memory performance', 'Neurocognitive effects', 'Cognitive performance']","[{'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0582587', 'cui_str': 'Visual learning'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",546.0,0.0209529,"At 12 months, three treatment groups had further improvements in three cognitive domains, but visual learning and memory performance dropped back to baseline.","[{'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Jiaheng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Peking University, Beijing, 100191, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}]",Nordic journal of psychiatry,['10.1080/08039488.2020.1771767']
2690,32496922,Three-dimensionally printed non-biological simulator for percutaneous nephrolithotomy training.,"Objective : We sought to improve the educational and pre-operative training on various stages of percutaneous nephrolithotomy (PCNL) under fluoroscopic and ultrasound guidance. We developed a three-dimensional (3D) printed simulator (3D-printed PCNL model) for urological trainees. Methods : 40 s year urology residents were randomly assigned into two groups, completing PCNL surgical steps on a URO Mentor™ surgical simulator (Group A) or on our new 3D-printed PCNL model (Group B). Following the training, both groups completed a standardized questionnaire (Likert scale from 0 to 10) which we used to asses the learning curve associated with PCNL training. Results : The mean score of Group A was 65.2/80 while Group B was 76.1/80. Mann-Whitney U-test showed no significant difference between the groups ( U = 16, p < 0.05). Conclusion : The 3D-printed PCNL model developed is a novel and highly effective tool that can facilitate enhanced endourological education and personalized pre-operative planning for urolithiasis cases. According to the criteria tested, residents who used our 3D-printed PCNL models performed better under all metrics.",2020,The 3D-printed PCNL model developed is a novel and highly effective tool that can facilitate enhanced endourological education and personalized pre-operative planning for urolithiasis cases.,"['s year urology residents', '40']","['percutaneous nephrolithotomy (PCNL) under fluoroscopic and ultrasound guidance', 'PCNL surgical steps on a URO Mentor™ surgical simulator (Group A) or on our new 3D-printed PCNL model', 'PCNL training', 'percutaneous nephrolithotomy training']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0185617,The 3D-printed PCNL model developed is a novel and highly effective tool that can facilitate enhanced endourological education and personalized pre-operative planning for urolithiasis cases.,"[{'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Evgenii', 'Initials': 'E', 'LastName': 'Sirota', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Evgenii', 'Initials': 'E', 'LastName': 'Bezrukov', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Zhamshid', 'Initials': 'Z', 'LastName': 'Okhunov', 'Affiliation': 'Department of Urology, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Bukatov', 'Affiliation': 'LLC «VERITEL», Moscow, Russia.'}, {'ForeName': 'Alexandr', 'Initials': 'A', 'LastName': 'Letunovskiy', 'Affiliation': 'LLC «VERITEL», Moscow, Russia.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Grygoriev', 'Affiliation': 'European Medical Center, Moscow, Russia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Taratkin', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Vovdenko', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Andyshea', 'Initials': 'A', 'LastName': 'Afyouni', 'Affiliation': 'Department of Urology, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Alyaev', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}]",Scandinavian journal of urology,['10.1080/21681805.2020.1773529']
2691,32497023,L-arginine supplementation in severe asthma.,"BACKGROUND
Dysregulation of L-arginine metabolism has been proposed to occur in severe asthma patients. The effects of L-arginine supplementation on L-arginine metabolite profiles in these patients is unknown. We hypothesized that severe asthmatics with low fractional exhaled nitric oxide (FeNO) would have fewer asthma exacerbations with the addition of L-arginine to their standard asthma medications compared to placebo and would demonstrate the greatest changes in metabolite profiles.
METHODS
Participants were enrolled in a single-center, cross-over, double-blinded, L-arginine intervention trial at the University of California-Davis (NCT01841281). Subjects received placebo or L-arginine, dosed orally at 0.05mg/kg (ideal body weight) twice daily. The primary endpoint was moderate asthma exacerbations. Longitudinal plasma metabolite levels were measured using mass spectrometry. A linear mixed-effect model with subject-specific intercepts was used for testing treatment effects.
RESULTS
A cohort of 50 subjects was included in the final analysis. L-arginine did not significantly decrease asthma exacerbations in the overall cohort. Higher citrulline levels and a lower arginine availability index (AAI) were associated with higher FeNO (P-value = 0.005 and 2.51 x 10-9 respectively). Higher AAI was associated with lower exacerbation events. The eicosanoid prostaglandin H2 (PGH2) and Nα-Acetyl-L-arginine were found to be good predictors for differentiating clinical responders and non-responders.
CONCLUSIONS
There was no statistically significant decrease in asthma exacerbations in the overall cohort with L-arginine intervention. PGH2, Nα-Acetyl-L-arginine and the AAI could serve as predictive biomarkers in future clinical trials that intervene in the arginine metabolome.",2020,Higher citrulline levels and a lower arginine availability index (AAI) were associated with higher FeNO (P-value = 0.005 and 2.51 x 10-9 respectively).,"['severe asthma patients', 'Participants were enrolled in a single-center, cross-over, double-blinded, L-arginine intervention trial at the University of California-Davis (NCT01841281', 'severe asthma', '50 subjects was included in the final analysis']","['L-arginine supplementation', 'placebo or L-arginine', 'placebo']","['asthma exacerbations', 'Longitudinal plasma metabolite levels', 'Higher citrulline levels and a lower arginine availability index (AAI', 'moderate asthma exacerbations', 'L-arginine metabolite profiles', 'eicosanoid prostaglandin H2 (PGH2) and Nα-Acetyl-L-arginine']","[{'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0013725', 'cui_str': 'Eicosanoid'}, {'cui': 'C0072288', 'cui_str': 'Prostaglandin PGH2'}]",50.0,0.280177,Higher citrulline levels and a lower arginine availability index (AAI) were associated with higher FeNO (P-value = 0.005 and 2.51 x 10-9 respectively).,"[{'ForeName': 'Shu-Yi', 'Initials': 'SY', 'LastName': 'Liao', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep Medicine, Department of Interna, UCD, Davis, United States of America.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Showalter', 'Affiliation': 'NIH West Coast Metabolomics Center, UCD, Davis, United States of America.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Linderholm', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep Medicine, Department of Interna, UCD, Davis, United States of America.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Franzi', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep Medicine, Department of Interna, UCD, Davis, United States of America.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Kivler', 'Affiliation': 'Department of Respiratory Therapy, UCD, Davis, United States of America.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Public Health Sciences, UCD, Davis, United States of America.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Sa', 'Affiliation': 'NIH West Coast Metabolomics Center, UCD, Davis, United States of America.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Kons', 'Affiliation': 'NIH West Coast Metabolomics Center, UCD, Davis, United States of America.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Fiehn', 'Affiliation': 'NIH West Coast Metabolomics Center, UCD, Davis, United States of America.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Public Health Sciences, UCD, Davis, United States of America.'}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Zeki', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep Medicine, Department of Interna, UCD, Davis, United States of America.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Kenyon', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep Medicine, Department of Interna, UCD, Davis, United States of America.'}]",JCI insight,['10.1172/jci.insight.137777']
2692,32497099,Redesign and validation of a computer programming course using Inductive Teaching Method.,"Inductive Teaching Method (ITM) promotes effective learning in technological education (Felder & Silverman, 1988). Students prefer ITM more as it makes the subject easily understandable (Goltermann, 2011). The ITM motivates the students to actively participate in class activities and therefore could be considered a better approach to teach computer programming. There has been little research on implementing ITM in computer science courses despite its potential to improve effective learning. In this research, an existing computer programming lab course is taught using a traditional Deductive Teaching Method (DTM). The course is redesigned and taught by adopting the ITM instead. Furthermore, a comprehensive plan has been devised to deliver the course content in computer labs. The course was evaluated in an experiment consisting of 81 undergraduate students. The students in the Experimental Group (EG) (N = 45) were taught using the redesigned ITM course, whereas the students in the Control Group (CG) (N = 36) were taught using the DTM course. The performance of both groups was compared in terms of the marks obtained by them. A pre-test conducted to compare pre-course mathematical and analytical abilities showed that CG was better in analytical reasoning with no significant differences in mathematical abilities. Three post-tests were used to evaluate the groups theoretical and practical competence in programming and showed EG improved performance with large, medium, and small effect sizes as compared to CG. The results of this research could help computer programming educators to implement inductive strategies that could improve the learning of the computer programming.",2020,"Three post-tests were used to evaluate the groups theoretical and practical competence in programming and showed EG improved performance with large, medium, and small effect sizes as compared to CG.",['81 undergraduate students'],['Inductive Teaching Method (ITM'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]",[],45.0,0.0100507,"Three post-tests were used to evaluate the groups theoretical and practical competence in programming and showed EG improved performance with large, medium, and small effect sizes as compared to CG.","[{'ForeName': 'Iftikhar Ahmed', 'Initials': 'IA', 'LastName': 'Khan', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Iftikhar', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Syed Sajid', 'Initials': 'SS', 'LastName': 'Hussain', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Attiqa', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Nosheen', 'Initials': 'N', 'LastName': 'Gul', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Jadoon', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Nazir', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}]",PloS one,['10.1371/journal.pone.0233716']
2693,32497217,Effects of proximal and distal enteral glucose infusion on cardiovascular response in health and type 2 diabetes.,"CONTEXT
Exposure of the small intestine to nutrients frequently leads to marked reductions in blood pressure (BP) in type 2 diabetes (T2DM). It remains unclear whether the region of the gut exposed to nutrients influences postprandial cardiovascular responses.
OBJECTIVE
To evaluated the cardiovascular responses to proximal and distal small intestinal glucose infusion in health and T2DM.
DESIGN
Double-blind, randomised, crossover design.
SETTING
Single center in Australia.
PATIENTS
10 healthy subjects and 10 T2DM patients.
INTERVENTIONS
Volunteers were studied on two occasions, when a transnasal catheter was positioned with infusion ports opening 13cm and 190cm beyond the pylorus. 30g glucose was infused into either site and 0.9% saline into the alternate site over 60min.
MAIN OUTCOME MEASURES
BP, heart rate (HR) and superior mesenteric artery (SMA) blood flow were measured over 180min.
RESULTS
Systolic BP was unchanged in response to both infusions in health, but decreased in T2DM, with a greater reduction after proximal vs. distal infusion (all P≤0.01). The increment in HR did not differ between treatments in health, but was greater after distal vs. proximal infusion in T2DM (P=0.02). The increases in SMA blood flow were initially greater, but less sustained, with proximal vs. distal infusion in health (P<0.001), a pattern less evident in T2DM.
CONCLUSIONS
In T2DM, postprandial hypotension may be mitigated by diversion of nutrients from the proximal to the distal small intestine.",2020,"The increment in HR did not differ between treatments in health, but was greater after distal vs. proximal infusion in T2DM (P=0.02).","['10 healthy subjects and 10 T2DM patients', '30', 'Single center in Australia', 'health and type 2 diabetes']",['proximal and distal enteral glucose infusion'],"['BP, heart rate (HR) and superior mesenteric artery (SMA) blood flow', 'Systolic BP', 'cardiovascular response', 'blood pressure (BP', 'increment in HR', 'SMA blood flow']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162861', 'cui_str': 'Superior mesenteric artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",10.0,0.0621509,"The increment in HR did not differ between treatments in health, but was greater after distal vs. proximal infusion in T2DM (P=0.02).","[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa341']
2694,32497219,The effect of metformin vs placebo on sex hormones in CCTG MA.32.,"BACKGROUND
Metformin has been associated with lower breast cancer risk and improved outcomes in observational studies. Multiple biologic mechanisms have been proposed, including a recent report of altered sex hormones (SHs). We evaluated the effect of metformin on SHs in MA.32, a phase III trial of nondiabetic BC subjects randomized to metformin or placebo.
METHODS
We studied the subgroup of post-menopausal hormone receptor negative BC subjects not receiving endocrine treatment who provided fasting blood at baseline and at 6 months after randomization. Sex hormone binding globulin (SHBG), bioavailable testosterone (BT) and estradiol levels were assayed using ECLIA (electrochemiluminescense immunoassay). Change from baseline to 6 months between study arms was compared using Wilcoxon sum rank tests and regression models.
RESULTS
312 women were eligible (141 metformin vs 171 placebo); the majority of subjects in each arm had T1/2, N0, HER2 negative BC and had received (neo)adjuvant chemotherapy. Mean age ± SD was 58.1±6.9 vs 57.5±7.9 years, mean BMI was 27.3±5.2 vs 28.9±6.4 kg/m2 for metformin vs placebo respectively. Median estradiol decreased between baseline and 6 months on metformin vs placebo (-5.7 vs 0 pmol/L; p < 0.001) in univariable analysis and after controlling for baseline BMI and BMI change (p < 0.001). There was no change in SHBG or BT.
CONCLUSION
Metformin lowered estradiol levels, independent of BMI. This observation suggests a new metformin effect that has potential relevance to estrogen sensitive cancers.",2020,"There was no change in SHBG or BT.
","['subgroup of post-menopausal hormone receptor negative BC subjects not receiving endocrine treatment who provided fasting blood at baseline and at 6 months after randomization', '312 women were eligible (141 metformin vs 171 placebo); the majority of subjects in each arm had T1/2, N0, HER2 negative BC and had received (neo)adjuvant chemotherapy', 'nondiabetic BC subjects']","['Metformin', 'metformin or placebo', 'metformin', 'metformin vs placebo', 'placebo']","['estradiol levels', 'Sex hormone binding globulin (SHBG), bioavailable testosterone (BT) and estradiol levels', 'Median estradiol', 'SHBG or BT', 'Mean age ± SD', 'mean BMI', 'baseline BMI and BMI change']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0370051', 'cui_str': 'Bioavailable testosterone'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",312.0,0.209572,"There was no change in SHBG or BT.
","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Pimentel', 'Affiliation': 'Vall d`Hebron Institute of Oncology (VHIO), Barcelona, Spain.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University - Cancer Research Institute, Kingston ON, Canada.""}, {'ForeName': 'Ana Elisa', 'Initials': 'AE', 'LastName': 'Lohmann', 'Affiliation': 'University of Western Ontario, ON Canada.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Ennis', 'Affiliation': 'Applied Statistician, 9227, Kennedy Road, Markham; ON, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University - Cancer Research Institute, Kingston ON, Canada.""}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Herbert Irving Cancer Center, Columbia University, New York, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Whelan', 'Affiliation': 'Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton ON, Canada.'}, {'ForeName': 'Vuk', 'Initials': 'V', 'LastName': 'Stambolic', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University, Vanderbilt - Ingram Cancer Center, Nashville TN, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hobday', 'Affiliation': 'Mayo Clinic, Rochester, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lemieux', 'Affiliation': 'CHA-Hopital Du St-Sacrement, Hopital Enfant Jesus Site, Quebec City, Canada.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh PA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'BCCA - Vancouver Cancer Centre, Vancouver BC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'Institute of Cancer Research, Clinical Trials and Statistics Unit, Sutton, UK.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'IBCSG Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ellard', 'Affiliation': 'BCCA - Cancer Centre for the Southern Interior, Kelowna BC, Canada.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston ON, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bedard', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Pitre', 'Affiliation': 'Health Sciences North, Sudbury ON, Canada.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Vandenberg', 'Affiliation': 'London Regional Cancer Program, London ON, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Jo Dowling', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University - Cancer Research Institute, Kingston ON, Canada.""}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Goodwin', 'Affiliation': 'Lunenfeld Tanenbaum Research Institute at Mount Sinai Hospital, University of Toronto, Canada.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa082']
2695,32497226,"Norsworthy KJ, Bird ST, Avagyan A, et al. Second cancers in adults with acute promyelocytic leukemia (APL) treated with or without arsenic trioxide (ATO): a SEER-Medicare analysis [abstract]. Blood. 2019;134(suppl 1). Abstract 3497.",,2020,,['adults with acute promyelocytic leukemia (APL) treated with or without'],['arsenic trioxide (ATO'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}]",[],,0.0127563,,[],Blood,['10.1182/blood.2020006455']
2696,32497234,Pilot of an Adaptive Learning Platform in a Graduate Nursing Education Pathophysiology Course.,"BACKGROUND
Adaptive learning (AL) platforms deliver content personalized to students on the basis of prior knowledge, adjusting content delivery based on individual preferences and differences in knowledge acquisition. This project compared a course developed in an AL platform with one in a traditional learning management system (LMS) only.
METHOD
This pilot of an adaptive graduate nurse educator pathophysiology course was a randomized control group experimental study.
RESULTS
Data from Fall 2018 and Spring 2019 semesters showed 86% of the participants (n = 21) strongly agreed that they learned better using an AL platform. All of the participants (N = 23) reported increased course engagement, and 86% (n = 21) reported they would like to take a course using this platform again.
CONCLUSION
This pilot demonstrated a potentially effective way to support students' learning. Students perceived greater engagement with content, reported more effective learning, and expressed interest in taking a course in an AL platform again. [J Nurs Educ. 2020;59(6):327-330.].",2020,"All of the participants (N = 23) reported increased course engagement, and 86% (n = 21) reported they would like to take a course using this platform again.
",['Graduate Nursing Education Pathophysiology Course'],"['Adaptive Learning Platform', 'Adaptive learning (AL) platforms']",[],"[{'cui': 'C0013641', 'cui_str': 'Graduate Nursing Education'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.0169236,"All of the participants (N = 23) reported increased course engagement, and 86% (n = 21) reported they would like to take a course using this platform again.
","[{'ForeName': 'Julie F', 'Initials': 'JF', 'LastName': 'Hinkle', 'Affiliation': ''}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Saccomano', 'Affiliation': ''}]",The Journal of nursing education,['10.3928/01484834-20200520-05']
2697,32497260,Vitamin K supplementation for cystic fibrosis.,"BACKGROUND
Malabsorption and deficiency of fat-soluble vitamins K may occur in cystic fibrosis, a genetic disorder affecting multiple organs. Vitamin K is known to play an important role in both blood coagulation and bone formation, hence the role of supplementation of vitamin K in this category needs to be reviewed. This is an updated version of the review.
OBJECTIVES
To assess the effects of vitamin K supplementation in people with cystic fibrosis and to investigate the hypotheses that vitamin K will decrease deficiency-related coagulopathy, increase bone mineral density, decrease risk of fractures and improve quality of life in people with CF. Also to determine the optimal dose and route of administration of vitamin K for people with CF (for both routine and therapeutic use).
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Most recent search: 12 August 2019.
SELECTION CRITERIA
Randomised controlled trials of all preparations of vitamin K used as a supplement compared to either no supplementation (or placebo) at any dose or route and for any duration, in patients with cystic fibrosis.
DATA COLLECTION AND ANALYSIS
Two authors independently screened papers, extracted trial details and assessed their risk of bias. The quality of the evidence was assessed using the GRADE criteria.
MAIN RESULTS
Three trials (total 70 participants, aged 8 to 46 years) assessed as having a moderate risk of bias were included. One trial compared vitamin K to placebo, a second to no supplementation and the third compared two doses of vitamin K. No trial in either comparison reported our primary outcomes of coagulation and quality of life or the secondary outcomes of nutritional parameters and adverse events. Vitamin K versus control Two trials compared vitamin K to control, but data were not available for analysis. One 12-month trial (n = 38) compared 10 mg vitamin K daily or placebo in a parallel design and one trial (n = 18) was of cross-over design with no washout period and compared 5 mg vitamin K/week for four-weeks to no supplementation for four-weeks. Only the 12-month trial reported on the primary outcome of bone formation; we are very uncertain whether vitamin K supplementation has any effect on bone mineral density at the femoral hip or lumbar spine (very low-quality evidence). Both trials reported an increase in serum vitamin K levels and a decrease in undercarboxylated osteocalcin levels. The cross-over trial also reported that levels of proteins induced by vitamin K absence (PIVKA) showed a decrease and a return to normal following supplementation, but due to the very low-quality evidence we are not certain that this is due to the intervention. High-dose versus low-dose vitamin K One parallel trial (n = 14) compared 1 mg vitamin K/day to 5 mg vitamin K/day for four weeks. The trial did report that there did not appear to be any difference in serum undercarboxylated osteocalcin or vitamin K levels (very low-quality evidence). While the trial reported that serum vitamin K levels improved with supplementation, there was no difference between the high-dose and low-dose groups.
AUTHORS' CONCLUSIONS
There is very low-quality evidence of any effect of vitamin K in people with cystic fibrosis. While there is no evidence of harm, until better evidence is available the ongoing recommendations by national CF guidelines should be followed.",2020,The trial did report that there did not appear to be any difference in serum undercarboxylated osteocalcin or vitamin K levels (very low-quality evidence).,"['people with cystic fibrosis', 'cystic fibrosis', 'patients with cystic fibrosis', 'Three trials (total 70 participants, aged 8 to 46 years) assessed as having a moderate risk of bias were included', 'people with CF']","['Vitamin K', 'no supplementation (or placebo', 'vitamin K supplementation', 'vitamin K daily or placebo', 'vitamin K', 'Vitamin K supplementation', 'vitamin K to placebo']","['quality of life', 'bone mineral density', 'serum vitamin K levels', 'undercarboxylated osteocalcin levels', 'serum undercarboxylated osteocalcin or vitamin K levels', 'coagulation and quality of life or the secondary outcomes of nutritional parameters and adverse events', 'bone formation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332166', 'cui_str': 'Moderate risk of'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443768', 'cui_str': 'Serum vitamin K measurement'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",70.0,0.547452,The trial did report that there did not appear to be any difference in serum undercarboxylated osteocalcin or vitamin K levels (very low-quality evidence).,"[{'ForeName': 'Vanitha A', 'Initials': 'VA', 'LastName': 'Jagannath', 'Affiliation': 'Department of Paediatrics, American Mission Hospital, Manama, Bahrain.'}, {'ForeName': 'Vidhu', 'Initials': 'V', 'LastName': 'Thaker', 'Affiliation': 'Division of Molecular Genetics and Department of Pediatrics, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'Amy I', 'Initials': 'AI', 'LastName': 'Price', 'Affiliation': 'Research and Development, Empower 2 Go, Edmonton, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008482.pub6']
2698,32497261,"NPC-0501 trial on the value of changing chemoradiotherapy sequence, replacing 5-fluorouracil with capecitabine, and altering fractionation for patients with advanced nasopharyngeal carcinoma.","BACKGROUND
A current recommendation for the treatment of patients with locoregionally advanced nasopharyngeal carcinoma (NPC) is conventional fractionated radiotherapy (RT) with concurrent cisplatin followed by adjuvant cisplatin and 5-fluorouracil (PF). This randomized NPC-0501 trial evaluated the therapeutic effect of changing to an induction-concurrent sequence or accelerated-fractionation sequence, and/or replacing 5-fluorouracil with capecitabine (X).
METHODS
Patients with American Joint Committee on Cancer/International Union Against Cancer stage III to stage IVB NPC initially were randomly allocated to 1 of 6 treatment arms (6-arm full-randomization cohort). The protocol was amended in 2009 to permit centers to opt out of randomization regarding fractionation (3-arm chemotherapy cohort).
RESULTS
A total of 803 patients were accrued (1 of whom was nonevaluable) from 2006 to 2012. Based on the overall comparisons, neither changing the chemotherapy sequence nor accelerated fractionation improved treatment outcome. However, secondary analyses demonstrated that when adjusted for RT parameters and other significant factors, the induction-concurrent sequence, especially the induction-PX regimen, achieved significant improvements in progression-free survival (PFS) and overall survival. Efficacy varied among different RT groups: although no impact was observed in the accelerated-fractionation group and the 3-arm chemotherapy cohort, a comparison of the induction-concurrent versus concurrent-adjuvant sequence in the conventional-fractionation group demonstrated a significant benefit in PFS (78% vs 62% at 5 years; P = .015) and a marginal benefit in overall survival (84% vs 72%; P = .042) after adjusting for multiple comparisons. Comparison of the induction-PX versus the adjuvant-PF regimen demonstrated better PFS (78% vs 62%; P = .027) without an increase in overall late toxicity.
CONCLUSIONS
For patients irradiated using conventional fractionation, changing the chemotherapy sequence from a concurrent-adjuvant to an induction-concurrent sequence, particularly using induction cisplatin and capecitabine, potentially could improve efficacy without an adverse impact on late toxicity. However, further validation is needed for confirmation of these findings.",2020,"Efficacy varied among different RT groups: although no impact was observed in the accelerated-fractionation group and the 3-arm chemotherapy cohort, a comparison of the induction-concurrent versus concurrent-adjuvant sequence in the conventional-fractionation group demonstrated a significant benefit in PFS (78% vs 62% at 5 years; P = .015) and a marginal benefit in overall survival (84% vs 72%; P = .042) after adjusting for multiple comparisons.","['patients with advanced nasopharyngeal carcinoma', 'Patients with American Joint Committee on Cancer/International Union Against Cancer stage III to stage IVB NPC initially', 'A total of 803 patients were accrued (1 of whom was nonevaluable) from 2006 to 2012', 'patients with locoregionally advanced nasopharyngeal carcinoma (NPC']","['conventional fractionated radiotherapy (RT) with concurrent cisplatin followed by adjuvant cisplatin and 5-fluorouracil (PF', '5-fluorouracil with capecitabine, and altering fractionation', '5-fluorouracil with capecitabine (X', 'cisplatin and capecitabine']","['progression-free survival (PFS) and overall survival', 'PFS', 'overall survival', 'Efficacy', 'overall late toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441914', 'cui_str': 'UICC'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441775', 'cui_str': 'Stage IVb'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",803.0,0.103638,"Efficacy varied among different RT groups: although no impact was observed in the accelerated-fractionation group and the 3-arm chemotherapy cohort, a comparison of the induction-concurrent versus concurrent-adjuvant sequence in the conventional-fractionation group demonstrated a significant benefit in PFS (78% vs 62% at 5 years; P = .015) and a marginal benefit in overall survival (84% vs 72%; P = .042) after adjusting for multiple comparisons.","[{'ForeName': 'Anne W M', 'Initials': 'AWM', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Guangdong, China.'}, {'ForeName': 'Roger K C', 'Initials': 'RKC', 'LastName': 'Ngan', 'Affiliation': 'Department of Clinical Oncology, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Wai-Tong', 'Initials': 'WT', 'LastName': 'Ng', 'Affiliation': 'Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Stewart Y', 'Initials': 'SY', 'LastName': 'Tung', 'Affiliation': 'Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Ashley A C', 'Initials': 'AAC', 'LastName': 'Cheng', 'Affiliation': 'Department of Clinical Oncology, Princess Margaret Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Dora L W', 'Initials': 'DLW', 'LastName': 'Kwong', 'Affiliation': 'Department of Clinical Oncology, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Tai-Xiang', 'Initials': 'TX', 'LastName': 'Lu', 'Affiliation': 'Department of Clinical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Anthony T C', 'Initials': 'ATC', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Henry C K', 'Initials': 'HCK', 'LastName': 'Sze', 'Affiliation': 'Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Harry H Y', 'Initials': 'HHY', 'LastName': 'Yiu', 'Affiliation': 'Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Frank C S', 'Initials': 'FCS', 'LastName': 'Wong', 'Affiliation': 'Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Kam-Tong', 'Initials': 'KT', 'LastName': 'Yuen', 'Affiliation': 'Department of Clinical Oncology, Princess Margaret Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Chappell', 'Affiliation': 'Department of Biostatistics, University of Wisconsin Medical School, Madison, Wisconsin, USA.'}, {'ForeName': 'Horace C W', 'Initials': 'HCW', 'LastName': 'Choi', 'Affiliation': 'Department of Clinical Oncology, The University of Hong Kong, Hong Kong, Hong Kong.'}]",Cancer,['10.1002/cncr.32972']
2699,32497409,Long-term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: Results from the B-YOND extension study.,"INTRODUCTION
Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B-LONG and Kids B-LONG studies. However, long-term rFIXFc safety and efficacy data have not yet been reported.
AIM
To report long-term rFIXFc safety and efficacy in subjects with haemophilia B.
METHODS
B-YOND (NCT01425723) was an open-label extension for eligibl previously treated subjects who completed B-LONG or Kids B-LONG. Subjects received ≥1 treatment regimen: weekly prophylaxis (WP), individualized interval prophylaxis (IP), modified prophylaxis or episodic treatment. Subjects could switch regimens at any time. The primary endpoint was inhibitor development.
RESULTS
Ninety-three subjects from B-LONG and 27 from Kids B-LONG (aged 3-63 years) were enrolled. Most subjects received WP (B-LONG: n = 51; Kids B-LONG: n = 23). For subjects from B-LONG, median (range) treatment duration was 4.0 (0.3-5.4) years and median (range) number of exposure days (EDs) was 146 (8-462) EDs. Corresponding values for paediatric subjects were 2.6 (0.2-3.9) years and 132 (50-256) EDs. No inhibitors were observed (0 per 1000 subject-years; 95% confidence interval, 0-8.9) and the overall rFIXFc safety profile was consistent with prior studies. Annualized bleed rates remained low and extended-dosing intervals were maintained for most subjects. Median dosing interval for the IP group was approximately 14 days for adults and adolescents (n = 31) and 10 days for paediatric subjects (n = 5).
CONCLUSIONS
B-YOND results confirm the long-term (up to 5 years, with cumulative duration up to 6.5 years) well-characterized safety and efficacy of rFIXFc treatment for haemophilia B.",2020,"No inhibitors were observed (0 per 1000 subject-years; 95% confidence interval, 0-8.9) and the overall rFIXFc safety profile was consistent with prior studies.","['subjects with haemophilia B', 'Ninety-three subjects from B-LONG and 27 from Kids B-LONG (aged 3-63\xa0years) were enrolled', 'eligibl previously treated subjects who completed B-LONG or Kids B-LONG']","['Recombinant factor IX Fc fusion protein (rFIXFc', '≥1 treatment regimen: weekly prophylaxis (WP), individualized interval prophylaxis (IP), modified prophylaxis or episodic treatment', 'rFIXFc', 'recombinant factor IX Fc fusion protein']","['inhibitor development', 'overall rFIXFc safety profile', 'Annualized bleed rates']","[{'cui': 'C0008533', 'cui_str': 'Factor IX deficiency'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C2826076', 'cui_str': 'Nonacog alfa'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2826076', 'cui_str': 'Nonacog alfa'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",93.0,0.0414276,"No inhibitors were observed (0 per 1000 subject-years; 95% confidence interval, 0-8.9) and the overall rFIXFc safety profile was consistent with prior studies.","[{'ForeName': 'K John', 'Initials': 'KJ', 'LastName': 'Pasi', 'Affiliation': 'Royal London Haemophilia Centre, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Kathelijn', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Van Creveldkliniek, University Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Ragni', 'Affiliation': 'Hemophilia Center of Western Pennsylvania, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Kulkarni', 'Affiliation': 'Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Margareth C', 'Initials': 'MC', 'LastName': 'Ozelo', 'Affiliation': 'Hemocentro UNICAMP, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Mahlangu', 'Affiliation': 'Haemophilia Comprehensive Care Centre, Faculty of Health Sciences, University of the Witwatersrand, and Charlotte Maxeke Johannesburg Academic Hospital and National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shapiro', 'Affiliation': 'Indiana Hemophilia & Thrombosis Center, Inc., Indianapolis, IN, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': ""P'Ng"", 'Affiliation': 'The Haemophilia and Haemostasis Centre, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Chambost', 'Affiliation': ""Children's Hospital La Timone, and Aix Marseille University, INSERM, INRA, C2VN, Marseille, France.""}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Nolan', 'Affiliation': ""Children's Health Ireland at Crumlin, Dublin, Ireland.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bennett', 'Affiliation': ""Emory University School of Medicine, Aflac Cancer and Blood Disorders Center of Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Matsushita', 'Affiliation': 'Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Winding', 'Affiliation': 'Sobi, Stockholm, Sweden.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Fruebis', 'Affiliation': 'Bioverativ, a Sanofi company, Waltham, MA, USA.'}, {'ForeName': 'Huixing', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Sanofi, Waltham, MA, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Rudin', 'Affiliation': 'Bioverativ, a Sanofi company, Waltham, MA, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Oldenburg', 'Affiliation': 'Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany.'}]",Haemophilia : the official journal of the World Federation of Hemophilia,['10.1111/hae.14036']
2700,32497453,Outside-in or Inside-out? A Randomized Controlled Trial of Two Empowerment Approaches for Family Caregivers of People with Schizophrenia.,"Training-based intervention such as psychoeducational groups has become increasingly popular to empower family caregivers of people with schizophrenia, yet existing supportive programs for caregivers tend to focus more on the needs of the patients rather than the development of the caregivers. This study aimed to compare the outcomes of a skill-based empowerment psychoeducational group and an inner-resource enhancing empowerment narrative therapy group for family caregivers of people with schizophrenia. We conducted a randomized controlled trial with a longitudinal design. The sample consisted of 132 family caregivers who were randomly assigned to eight sessions of the two groups (i.e. a narrative-based group, or a psychoeducational group), or a control group with delayed treatment. Psychometric scales were administrated throughout the project. Both the psychoeducational group and the narrative group showed significant improvements in family relationships, caregiving burden, and coping skills compared with the control group across the three time points (pretest, posttest, and 2-month follow-up). A statistically significant advancement in coping skills was found in the psychoeducational group. The narrative group outperformed the psychoeducational group and the control group in the enhancement of inner resources, perceived control, and level of hope. The findings call for the need of an integrative empowerment approach that both values the inner strength and unique experiences of the caregivers and at the same time provides them with necessary skills and knowledge in taking care of their family members with schizophrenia.",2020,"The narrative group outperformed the psychoeducational group and the control group in the enhancement of inner resources, perceived control, and level of hope.","['Family Caregivers of People with Schizophrenia', 'family caregivers of people with schizophrenia', '132 family caregivers']","['control group with delayed treatment', 'skill-based empowerment psychoeducational group and an inner-resource enhancing empowerment narrative therapy']","['family relationships, caregiving burden, and coping skills', 'coping skills', 'Psychometric scales']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3693346', 'cui_str': 'Treatment Delay'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C3494322', 'cui_str': 'Narrative Therapy'}]","[{'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",132.0,0.0357367,"The narrative group outperformed the psychoeducational group and the control group in the enhancement of inner resources, perceived control, and level of hope.","[{'ForeName': 'De-Hui Ruth', 'Initials': 'DR', 'LastName': 'Zhou', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, North Point, Hong Kong.'}, {'ForeName': 'Yu-Lung Marcus', 'Initials': 'YM', 'LastName': 'Chiu', 'Affiliation': 'Department of Applied Social Science, City University of Hong Kong, Kowloon, Hong Kong.'}, {'ForeName': 'Tak-Lam William', 'Initials': 'TW', 'LastName': 'Lo', 'Affiliation': 'Mental Health, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Wai-Fan Alison', 'Initials': 'WA', 'LastName': 'Lo', 'Affiliation': 'Mental Health, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Siu-Sing', 'Initials': 'SS', 'LastName': 'Wong', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, North Point, Hong Kong.'}, {'ForeName': 'Kwok-Leung', 'Initials': 'KL', 'LastName': 'Luk', 'Affiliation': 'Department Operations Manager, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Chi-Hoi Tom', 'Initials': 'CT', 'LastName': 'Leung', 'Affiliation': 'East Kowloon Psychistric Center, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Chui-Kam', 'Initials': 'CK', 'LastName': 'Yu', 'Affiliation': 'East Kowloon Psychistric Center, Kwai Chung Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Yuk Sing Geoffrey', 'Initials': 'YSG', 'LastName': 'Chang', 'Affiliation': 'East Kowloon Psychistric Center, Kwai Chung Hospital, Kowloon, Hong Kong.'}]",Issues in mental health nursing,['10.1080/01612840.2020.1734992']
2701,32497454,The effect of low-volume high-intensity interval training on cardiometabolic health and psychological responses in overweight/obese middle-aged men.,"High-intensity interval training (HIIT) has been proposed as a time-efficient exercise protocol to improve metabolic health, but direct comparisons with higher-volume moderate-intensity continuous training (MICT) under unsupervised settings are limited. This study compared low-volume HIIT and higher-volume MICT interventions on cardiometabolic and psychological responses in overweight/obese middle-aged men. Twenty-four participants (age: 48.1±5.2yr; BMI: 25.8±2.3kg·m -2 ) were randomly assigned to undertake either HIIT (10 X 1-min bouts of running at 80-90% HR max separated by 1-min active recovery) or MICT (50-min continuous jogging/brisk walking at 65-70% HR max ) for 3 sessions/week for 8 weeks (2-week supervised + 6-week unsupervised training). Both groups showed similar cardiovascular fitness (VO 2max ) improvement (HIIT: 32.5±5.6 to 36.0±6.2; MICT: 34.3±6.0 to 38.2±5.1mL kg -1 min -1 , p < 0.05) and %fat loss (HIIT: 24.5±3.4 to 23.2±3.5%; MICT: 23.0±4.3 to 21.5±4.1%, p< 0.05) over the 8-week intervention. Compared to baseline, MICT significantly decreased weight and waist circumference. No significant group differences were observed for blood pressure and cardiometabolic blood markers such as lipid profiles, fasting glucose and glycated haemoglobin. Both groups showed similar enjoyment levels and high unsupervised adherence rates (>90%). Our findings suggest that low-volume HIIT can elicit a similar improvement of cardiovascular fitness as traditional higher-volume MICT in overweight/obese middle-aged men.",2020,Both groups showed similar cardiovascular fitness (VO 2max ) improvement (HIIT: 32.5±5.6 to 36.0±6.2; MICT: 34.3±6.0 to 38.2±5.1mL ,"['overweight/obese middle-aged men', 'Twenty-four\xa0participants (age: 48.1±5.2yr; BMI:\xa025.8±2.3kg·m -2 ', 'overweight/obese middle-aged\xa0men']","['High-intensity\xa0interval training (HIIT', 'low-volume\xa0HIIT and higher-volume\xa0MICT interventions', 'HIIT (10 X 1-min bouts of running at\xa080-90', 'low-volume high-intensity interval training', 'MICT']","['fat loss ', 'cardiometabolic health and psychological responses', 'weight and waist circumference', 'cardiovascular fitness\xa0(VO 2max )\xa0improvement', 'cardiovascular fitness', 'enjoyment levels and high unsupervised adherence rates', 'blood pressure and cardiometabolic blood markers such as lipid profiles, fasting glucose and glycated haemoglobin', 'cardiometabolic and psychological responses']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",-2.0,0.0226287,Both groups showed similar cardiovascular fitness (VO 2max ) improvement (HIIT: 32.5±5.6 to 36.0±6.2; MICT: 34.3±6.0 to 38.2±5.1mL ,"[{'ForeName': 'Eric Tsz-Chun', 'Initials': 'ET', 'LastName': 'Poon', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong , Shatin, Hong Kong.'}, {'ForeName': 'Jonathan Peter', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan , Kelowna, BC, Canada.'}, {'ForeName': 'Cindy Hui-Ping', 'Initials': 'CH', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong , Shatin, Hong Kong.'}, {'ForeName': 'Stephen Heung-Sang', 'Initials': 'SH', 'LastName': 'Wong', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong , Shatin, Hong Kong.'}]",Journal of sports sciences,['10.1080/02640414.2020.1766178']
2702,32497489,Tranexamic Acid Is Associated With Improved Operative Field in Orthognathic Surgery.,"PURPOSE
In the past, both tranexamic acid and dexmedetomidine have been used separately to decrease intraoperative blood loss during orthognathic surgery. However, their combined use in the same setting has never been prospectively evaluated. The present study was conducted to evaluate the effect of tranexamic acid on operative field visibility and blood loss during orthognathic surgery after dexmedetomidine-induced hypotensive anesthesia.
PATIENTS AND METHODS
The present prospective, randomized clinical trial included patients who had undergone orthognathic surgery under general anesthesia. The patients were divided into 2 groups. The dexmedetomidine and tranexamic (DT) group received an intravenous bolus of tranexamic acid (15 mg/kg) and intravenous dexmedetomidine (0.25 to 0.7 μg/kg/hr) as maintenance infusion. The dexmedetomidine (DS) group received only intravenous dexmedetomidine at the same dosage. All the patients had received a bolus dose of intravenous dexmedetomidine (1 μg/kg) before the start of anesthesia induction. The operating surgeon rated the quality of the surgical visual field every 15 minutes using the Fromme ordinal scale. Intraoperative blood loss was estimated using the modified gross formula. The operating surgeon's satisfaction was assessed using a Likert scale. Data were analyzed using SPSS, version 22.0 (IBM Corp, Armonk, NY). Kolmogorov-Smirnov tests were used to assess the normality of the measured data, and categorical variables were analyzed using the χ 2 or Fischer exact test.
RESULTS
The study sample included 36 patients, with a mean age of 23.67 ± 11.298 years in the DS group and 20.28 ± 3.286 years in the DT group. Of the patients in the DS and DT groups, 66.66 and 61.11% were male, respectively. No statistically significant differences were found in the baseline characteristics between the 2 treatment groups. The surgeon reported a significantly better surgical visual field in the DT group compared with that in the DS group (P = .001). Also, the intraoperative blood loss significantly less in the DT group (231.11 ± 137.64 mL vs 360.17 ± 187.86 mL; P = .025).
CONCLUSIONS
Tranexamic acid improved surgical field visibility and reduced intraoperative blood loss when administered in conjunction with dexmedetomidine during orthognathic surgery under controlled hypotensive anesthesia.",2020,"Also, the intraoperative blood loss significantly less in the DT group (231.11 ± 137.64 ","['orthognathic surgery after dexmedetomidine-induced hypotensive anesthesia', '36 patients, with a mean age of 23.67\xa0±\xa011.298\xa0years in the DS group and 20.28\xa0±\xa03.286\xa0years in the DT group', 'Orthognathic Surgery', 'patients who had undergone orthognathic surgery under general anesthesia']","['dexmedetomidine (DS', 'tranexamic acid and dexmedetomidine', 'Tranexamic Acid', 'dexmedetomidine and tranexamic (DT', 'tranexamic acid', 'dexmedetomidine', 'Tranexamic acid']","['operative field visibility and blood loss', 'surgical field visibility and reduced intraoperative blood loss', 'surgical visual field', 'intraoperative blood loss', 'Intraoperative blood loss']","[{'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}]",36.0,0.0629391,"Also, the intraoperative blood loss significantly less in the DT group (231.11 ± 137.64 ","[{'ForeName': 'Harjinder', 'Initials': 'H', 'LastName': 'Sharma', 'Affiliation': 'Junior Resident, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Professor, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Bhatia', 'Affiliation': 'Additional Professor, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: nidhi.bhatia75@gmail.com.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Rattan', 'Affiliation': 'Additional Professor, Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Professor, Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.04.037']
2703,32497491,"Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial.","BACKGROUND
Long-acting injectable cabotegravir is a novel integrase inhibitor currently in advanced clinical development for HIV prevention and treatment. We aimed to assess the terminal phase pharmacokinetics and safety of long-acting injectable cabotegravir in participants included in the HPTN 077 trial.
METHODS
HPTN 077 was a multicentre, double-blind, randomised, placebo-controlled phase 2a trial done at eight sites in Brazil, Malawi, South Africa, and the USA. Participants (aged 18-65 years), who were HIV-uninfected and at low-risk for HIV, were randomly assigned (3:1) to long-acting injectable cabotegravir (800 mg given three times at 12 week intervals or 600 mg given five times, administered at one 4 week interval, and every 8 weeks thereafter) or placebo. Participants were followed up to 76 weeks after final injection. In a prespecified analysis of secondary and exploratory outcomes, we assessed the safety, measured by the proportion of participants with grade 2 or worse adverse events, and pharmacokinetics, measured by apparent terminal phase half-life (t 1/2app ) and estimated time to lower limit of quantification (LLOQ) of long-acting injectable cabotegravir during the injection phase (defined as the time between first injection and 12 weeks or 8 weeks after the last injection in cohort 1 or cohort 2 respectively) and tail phase (defined as the time between final injection and 52-76 weeks post-final injection). Safety was analysed in all participants who received at least one injection. Pharmacokinetic analyses included all participants who had received at least one injection and had at least three cabotegravir measurements higher than the LLOQ after the final injection. Pharmacokinetic outcomes were estimated using non-compartmental methods. The trial is completed, and was registered with ClinicalTrials.gov, NCT02178800.
FINDINGS
Between Feb 9, 2015, and May 27, 2016, 177 participants (134 participants in the cabotegravir group [74 participants in cohort 1; 60 participants in cohort 2] and 43 participants in the placebo group [25 participants in cohort 1; 18 participants in cohort 2) were enrolled and received at least one injection and thus were included in the safety analysis. The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001). At 52-60 weeks after final injection, nine (23%) of 40 male participants had detectable cabotegravir concentrations and at week 76, four (13%) of 30 male participants had detectable cabotegravir concentrations compared with 52 (63%) of 82 female participants and 27 (42%) of 64 female participants at the same timepoints. The median time from the last injection to the time when cabotegravir concentration decreased below the LLOQ was 43·7 weeks (IQR 31·1-66·6; range 20·4-152·5) for male participants and 67·3 weeks (29·1-89·6; 17·7-225·5) for female participants (p=0·0003). t 1/2app was longer for female participants than male participants (geometric mean fold-change 1·33, 95% CI 1·06-1·68; p=0·014), and longer for participants with a high body-mass index (BMI) than those with a low BMI (1·31, 1·06-1·63; p=0·015).
INTERPRETATION
The clinical significance of the long pharmacokinetic tail of cabotegravir observed in female participants compared with male participants, and those with higher BMI compared with a lower BMI, need to be addressed in future trials.
FUNDING
National Institute of Allergy and Infectious Diseases.",2020,The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001).,"['Participants (aged 18-65 years), who were HIV-uninfected and at low-risk for HIV', 'participants who had received at least one injection and had at least three cabotegravir measurements higher than the LLOQ after the final injection', '82 female participants and 27 (42%) of 64 female participants at the same timepoints', 'HIV-uninfected adults', 'participants included in the HPTN 077 trial', 'Between Feb 9, 2015, and May 27, 2016, 177 participants (134 participants in the cabotegravir group [74 participants in cohort 1; 60 participants in cohort 2] and 43 participants in the placebo group [25 participants in cohort 1; 18 participants in cohort 2', 'female participants compared with male participants']","['long-acting injectable cabotegravir', 'placebo']","['Safety', 'Pharmacokinetic outcomes', 'median time', 'detectable cabotegravir concentrations', 'cabotegravir concentration', 'Tail-phase safety, tolerability, and pharmacokinetics', 'incidence of grade 2 or worse adverse events', 'proportion of participants with grade 2 or worse adverse events, and pharmacokinetics, measured by apparent terminal phase half-life (t 1/2app ) and estimated time to lower limit of quantification (LLOQ) of long-acting injectable cabotegravir']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]",40.0,0.577418,The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001).,"[{'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'UCLA Center for Clinical AIDS Research and Education, Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: rlandovitz@mednet.ucla.edu.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Dawood', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Albert Y', 'Initials': 'AY', 'LastName': 'Liu', 'Affiliation': 'Bridge HIV, Population Health Division, San Francisco Department of Health, San Francisco, CA, USA.'}, {'ForeName': 'Manya', 'Initials': 'M', 'LastName': 'Magnus', 'Affiliation': 'Department of Epidemiology, Milken Institute School of Public Health at The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Ravindre', 'Initials': 'R', 'LastName': 'Panchia', 'Affiliation': 'Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cottle', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chau', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Kofron', 'Affiliation': 'UCLA Center for Clinical AIDS Research and Education, Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Adeola', 'Initials': 'A', 'LastName': 'Adeyeye', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burns', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': 'FHI 360, Washington, DC, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30106-5']
2704,32497520,"39·0°C versus 38·5°C ear temperature as fever limit in children with neutropenia undergoing chemotherapy for cancer: a multicentre, cluster-randomised, multiple-crossover, non-inferiority trial.","BACKGROUND
Fever in neutropenia is the most frequent complication of chemotherapy for cancer. The temperature limit defining fever used clinically varies. A higher limit can avoid unnecessary diagnoses in patients spontaneously recovering from fever. This trial primarily aimed to determine if a limit of 39·0°C ear temperature is non-inferior to 38·5°C regarding safety.
METHODS
This cluster-randomised, multiple crossover, non-blinded, non-inferiority trial was done in six Swiss Paediatric Oncology Group centres (clusters) in Switzerland. Patients (aged 1 to <18 years) with any malignancy and treated with myelosuppressive chemotherapy expected to last 2 months or more were repeatedly randomly assigned (1:1), at the cluster level, to either monthly 39·0°C or 38·5°C ear temperature limits for diagnosis of fever in neutropenia. Diagnosis below the randomised limit was allowed for clinical reasons. Such a diagnosis implied emergency hospitalisation, examinations (including blood culture), as-needed antipyretics, and empirical intravenous broad-spectrum antibiotics. The primary outcome was the rate of fever in neutropenia with safety relevant events (SRE) per chemotherapy year; we also assessed efficacy in terms of rate of fever in neutropenia. The non-inferiority margin was 1·33 for safety, and for effiacy, the superiority margin was 1·00. This trial is registered at ClinicalTrials.gov, number NCT02324231.
FINDINGS
269 patients were recruited between April 28, 2016, to Aug 27, 2018, until the trial was stopped for success after the second interim analysis. Patients were repeatedly randomly assigned, with 1210 (48%) of 2547 randomisation periods and 92 (47%) of 195 chemotherapy years randomised to 39·0°C. SREs were diagnosed in 72 (20%) of 360 fever in neutropenia episodes (zero deaths, 16 intensive care unit admissions, 22 cases of severe sepsis, and 56 cases of bacteraemia). In 92 chemotherapy years randomised to the 39·0°C fever limit, 151 episodes of fever with neutropenia were diagnosed (1·64 per year), including 22 (15%) with SRE (0·24 per year). In 103 chemotherapy years randomised to 38·5°C, 209 episodes were diagnosed (2·03 per year), including 50 (24%) with SRE (0·49 per year). The mixed Poisson regression rate ratio (RR) of fever in neutropenia with SRE in 39·0°C versus 38·5°C was 0·56 (95% upper confidence bound 0·72). The corresponding RR of fever in neutropenia was 0·83 (95% upper confidence bound 0·98).
INTERPRETATION
In children with neutropenia and chemotherapy for cancer, 39·0°C ear temperature was safe and seemed efficacious. For Switzerland and comparable settings, 39·0°C can be recommended as new evidence-based standard fever limit except for patients with acute myeloid leukaemia or haematopoietic stem cell transplantation.
FUNDING
Swiss Cancer League (KLS-3645-02-2015).",2020,The corresponding RR of fever in neutropenia was 0·83,"['patients spontaneously recovering from fever', 'children with neutropenia undergoing chemotherapy for cancer', '269 patients were recruited between April 28, 2016, to Aug 27, 2018, until the trial was stopped for success after the second interim analysis', '103 chemotherapy years randomised to 38·5', 'six Swiss Paediatric Oncology Group centres (clusters) in Switzerland', 'patients with acute myeloid leukaemia or haematopoietic stem cell transplantation', 'Patients (aged 1 to <18 years) with any malignancy and treated with myelosuppressive chemotherapy expected to last 2 months or more were repeatedly randomly assigned (1:1), at the cluster level, to either monthly 39·0°C or 38·5']",[],"['rate of fever in neutropenia', 'fever with neutropenia', 'mixed Poisson regression rate ratio (RR) of fever in neutropenia with SRE', 'SREs', 'corresponding RR of fever in neutropenia', 'rate of fever in neutropenia with safety relevant events (SRE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",269.0,0.380971,The corresponding RR of fever in neutropenia was 0·83,"[{'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Koenig', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bodmer', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Philipp K A', 'Initials': 'PKA', 'LastName': 'Agyeman', 'Affiliation': 'Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Niggli', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Adam', 'Affiliation': 'Unit of Pediatric Hematology-Oncology, Woman-Mother-Child Department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, University Hospital of Geneva, Geneva, Switzerland; Department of Paediatrics, CANSEARCH Research Laboratory, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Eisenreich', 'Affiliation': ""Department of Pediatric Oncology and Hematology, Children's Hospital Lucerne, Lucerne, Switzerland.""}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Keller', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Leibundgut', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nadal', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Roessler', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Scheinemann', 'Affiliation': ""Division of Pediatric Hematology and Oncology, Department of Pediatrics, Kantonsspital Aarau, Aarau, Switzerland; Division of Pediatric Hematology and Oncology, University Children's Hospital Basel, University of Basel, Basel, Switzerland; Department of Pediatrics, McMaster Children's Hospital and McMaster University, Hamilton, ON, Canada.""}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital Medical Centre, University Hospital of Saarland, Homburg, Germany.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Teuffel', 'Affiliation': 'University of Tuebingen, Tuebingen, Germany; Division of Oncology, Medical Services of the Statutory Health Insurance, Baden-Wuerttemberg, Germany.'}, {'ForeName': 'Nicolas X', 'Initials': 'NX', 'LastName': 'von der Weid', 'Affiliation': ""Division of Pediatric Hematology and Oncology, University Children's Hospital Basel, University of Basel, Basel, Switzerland.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zeller', 'Affiliation': 'Swiss Paediatric Oncology Group, Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Zimmermann', 'Affiliation': ""Children's Research Centre, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland; Department Public Health-Nursing Science, Faculty of Medicine, University Basel, Basel, Switzerland.""}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Ammann', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: roland.ammann@insel.ch.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30092-4']
2705,32497524,"Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial.","BACKGROUND
Chikungunya disease, which results in incapacitating arthralgia, has been reported worldwide. We developed a live-attenuated chikungunya virus (CHIKV) vaccine candidate designed for active immunisation of the general population living in endemic regions, as well as serving as a prophylactic measure for travellers to endemic areas.
METHODS
This single-blind, randomised, dose-escalation, phase 1 study investigated as primary outcome safety of a live-attenuated CHIKV vaccine candidate. At two professional clinical trial centres in Illinois and Alabama, USA, healthy volunteers aged 18-45 years were randomly assigned (1:1:2) to one of three escalating dose groups (low dose 3·2 × 10 3 per 0·1 mL; medium dose 3·2 × 10 4 per 1 mL; or high dose 3·2 × 10 5 50% tissue culture infection dose per 1 mL) and received a single-shot immunisation on day 0. Individuals in all groups were revaccinated with the highest dose on either month 6 or 12, and followed up for 28 days after revaccination. The safety analysis included all individuals who received the single vaccination; the immunogenicity analysis, which was a secondary outcome, included all individuals who completed the study without major protocol deviations (per-protocol population). The study is registered with ClinicalTrials.gov, NCT03382964, and is complete.
FINDINGS
The study was done between March 5, 2018, and Jul 23, 2019, with 120 adults recruited and enrolled between March 5 and June 21, 2018, and assigned to receive a low (n=31), medium (n=30), or high (n=59) dose of the vaccine. The vaccine was safe in the high-dose group and well tolerated in the low-dose and medium-dose groups. Four (7%) of 59 vaccinees in the high-dose group reported any local reaction, and 11 (36%), 12 (40%), and 40 (68%) volunteers in the low-dose, medium-dose, and high-dose groups, respectively, reported any solicited systemic reaction. No vaccine-related serious adverse events were reported. Data up to month 12 after a single immunisation of the 120 healthy volunteers showed a good immunogenicity profile with 100% seroconversion rates achieved at day 14 (103 [100%] of 103) and sustained for 1 year across all dose groups. Mean peak antibody titres at day 28 ranged from 592·6 to 686·9 geometric mean titres from the low-dose to high-dose groups, respectively. A single vaccination was sufficient to induce sustaining high-titre neutralising antibodies, as shown by the absence of an anamnestic response after any revaccination ranging from 94% to 100% of participants. Following revaccination, vaccinees were protected from vaccine-induced viraemia.
INTERPRETATION
A novel live-attenuated CHIKV vaccine was well tolerated and highly immunogenic in an adult population and could be an effective intervention for prophylaxis of chikungunya disease worldwide.
FUNDING
Valneva, Vienna, Austria; Coalition for Epidemic Preparedness Innovation and EU Horizon 2020.",2020,"Mean peak antibody titres at day 28 ranged from 592·6 to 686·9 geometric mean titres from the low-dose to high-dose groups, respectively.","['120 healthy volunteers', 'individuals who received the single vaccination; the immunogenicity analysis, which was a secondary outcome, included all individuals who completed the study without major protocol deviations (per-protocol population', 'At two professional clinical trial centres in Illinois and Alabama, USA, healthy volunteers aged 18-45 years', 'healthy adults', 'March 5, 2018, and Jul 23, 2019, with 120 adults recruited and enrolled between March 5 and June 21, 2018, and assigned to receive a low (n=31), medium (n=30), or high (n=59) dose of the', '3·2\u2008×', 'active immunisation of the general population living in endemic regions']","['Single-shot live-attenuated chikungunya vaccine', 'live-attenuated CHIKV vaccine candidate', 'vaccine', 'medium dose\u20083·2', 'live-attenuated chikungunya virus (CHIKV) vaccine']","['local reaction', 'solicited systemic reaction', 'tolerated', 'seroconversion rates', 'Mean peak antibody titres', 'good immunogenicity profile']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205991', 'cui_str': 'Active immunization'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008055', 'cui_str': 'Chikungunya fever'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008056', 'cui_str': 'Chikungunya virus'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",120.0,0.316388,"Mean peak antibody titres at day 28 ranged from 592·6 to 686·9 geometric mean titres from the low-dose to high-dose groups, respectively.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wressnigg', 'Affiliation': 'Valneva, Vienna, Austria. Electronic address: nina.wressnigg@valneva.com.'}, {'ForeName': 'Romana', 'Initials': 'R', 'LastName': 'Hochreiter', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zoihsl', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fritzer', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bézay', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Klingler', 'Affiliation': 'Assign Data Management and Biostatistics, Innsbruck, Austria.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lingnau', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Lundberg', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meinke', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Larcher-Senn', 'Affiliation': 'Assign Data Management and Biostatistics, Innsbruck, Austria.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Čorbic-Ramljak', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eder-Lingelbach', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Dubischar', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bender', 'Affiliation': 'Valneva, Vienna, Austria.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30238-3']
2706,32497553,A randomised controlled trial investigating efficacy of a novel toothpaste containing calcium silicate and sodium phosphate in dentine hypersensitivity pain reduction compared to a fluoride control toothpaste.,"OBJECTIVES
To compare a calcium silicate and sodium phosphate toothpaste (CSSP) with a fluoride negative control toothpaste for dentine hypersensitivity (DH) pain reduction after 14, 28 and 29 days.
METHODS
This was a double blind, parallel study in 247 healthy adults with DH (Schiff score >2, tactile 10-20 g) in 2 teeth in different quadrants of the mouth. After acclimatisation, participants were randomised to CSSP or control toothpaste. After measuring baseline sensitivity products were applied twice-daily by toothbrushing, and once daily massaging into the sensitive teeth. Sensitivity was assessed following airblast (Schiff and VAS) and tactile (Yeaple probe) stimuli at baseline, 14 and 28 days, and at 29 days, 12 h after last product application. Participants completed a quality of life questionnaire at each study visit up to day 28.
RESULTS
After 14, 28 and 29 days the CSSP group had significantly lower Schiff, lower VAS and higher Yeaple probe scores compared to control (VAS at 14 days, p < 0.04; all other comparisons, p < 0.001). Quality of life scores improved in both groups, but no significant differences between groups were observed.
CONCLUSIONS
The CSSP toothpaste was more effective than the fluoride control toothpaste at reducing DH pain with benefit persisting 12 h following application.
CLINICAL SIGNIFICANCE
This novel calcium silicate and sodium phosphate toothpaste (CSSP) toothpaste is an effective twice-daily treatment when brushed on the teeth for dentine hypersensitivity sufferers compared to brushing with a conventional fluoride paste. Twice-daily brushing provides a sustained effect for long-lasting pain relief from dentine hypersensitivity.",2020,"After 14, 28 and 29 days the CSSP group had significantly lower Schiff, lower VAS and higher Yeaple probe scores compared to control (VAS at 14 days, p < 0.04; all other comparisons, p < 0.001).","['dentine hypersensitivity (DH) pain reduction after 14, 28 and 29 days', '247 healthy adults with DH (Schiff score >2, tactile 10-20\u2009g) in 2 teeth in different quadrants of the mouth']","['CSSP', 'fluoride negative control toothpaste', 'calcium silicate and sodium phosphate toothpaste (CSSP', 'sodium phosphate toothpaste (CSSP) toothpaste', 'novel toothpaste containing calcium silicate and sodium phosphate', 'fluoride control toothpaste', 'CSSP toothpaste', 'CSSP or control toothpaste']","['airblast (Schiff and VAS) and tactile (Yeaple probe) stimuli', 'Quality of life scores', 'DH pain', 'lower Schiff, lower VAS and higher Yeaple probe scores', 'quality of life questionnaire', 'Sensitivity', 'dentine hypersensitivity pain reduction']","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0074757', 'cui_str': 'sodium phosphate'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",247.0,0.192859,"After 14, 28 and 29 days the CSSP group had significantly lower Schiff, lower VAS and higher Yeaple probe scores compared to control (VAS at 14 days, p < 0.04; all other comparisons, p < 0.001).","[{'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Seong', 'Affiliation': 'Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: J.Seong@bristol.ac.uk.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Newcombe', 'Affiliation': 'Institute of Primary Care & Public Health, Cardiff University, Cardiff, CF10 3AT, UK. Electronic address: newcombe@cardiff.ac.uk.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Matheson', 'Affiliation': 'Unilever Oral Care, Quarry Road East, Bebington, CH63 3JU, UK. Electronic address: Jane.Matheson@unilever.com.'}, {'ForeName': 'Lynnette', 'Initials': 'L', 'LastName': 'Weddell', 'Affiliation': 'Unilever Oral Care, Quarry Road East, Bebington, CH63 3JU, UK. Electronic address: Lynnette.Weddell@unilever.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': 'Unilever Oral Care, Unilever House, 100 Victoria Embankment, London, EC4Y 0DY, UK. Electronic address: Mark.Edwards@unilever.com.'}, {'ForeName': 'Nicola X', 'Initials': 'NX', 'LastName': 'West', 'Affiliation': 'Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: n.x.west@bristol.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103320']
2707,32497586,Cardiovascular adaptations after 10 months of daily 12-min bouts of intense school-based physical training for 8-10-year-old children.,"The present study examined cardiovascular adaptations in 8-10-year-old schoolchildren after a full school year (10 months) of 5 × 12 min/wk. of intense physical training, including small-sided ball games (soccer, basketball and floorball) or interval running. The study involved 8-10-year-old healthy Danish schoolchildren (n = 232), who were cluster-randomized to a small-sided games group (SSG, n = 60), an interval running group (IR, n = 57) or a control group (CON, n = 115). Comprehensive transthoracic echocardiography, resting heart rate and blood pressure measurements were performed at baseline and post intervention. For interval running, analysis of baseline-to-10-months changes showed significant (P < 0.05) between-group differences in delta scores for diastolic blood pressure (BP) and mean arterial BP (IR -3.2 ± 5.7 and - 2.2 ± 6.5 mmHg vs. CON 0.2 ± 5.3 and 0.4 ± 6.4 mmHg, respectively). Delta scores also showed a trend for reduction of mean arterial BP in SSG compared to CON (-2.1 ± 6.0 vs. 0.2 ± 5.3 mmHg, P = 0.067). Moreover, there were between-group differences in delta scores (P < 0.05) for selected echocardiographic parameters, i.e. in SSG vs. CON for interventricular septum thickness and peak transmitral flow velocity in early diastole, and in IR vs. CON for left ventricular systolic diameter. In conclusion, 10 months of 5 × 12 min/wk. of IR in 8-10-year-old children decreased diastolic BP, while both IR and SSG elicited cardiac adaptations. The results suggest that frequent low volume, intense physical training can have effects on the cardiovascular health profile in healthy children.",2020,"Moreover, there were between-group differences in delta scores (P < 0.05) for selected echocardiographic parameters, i.e. in SSG vs. CON for interventricular septum thickness and peak transmitral flow velocity in early diastole, and in IR vs. CON for left ventricular systolic diameter.","['8-10-year-old schoolchildren after a full school year (10\u202fmonths) of 5\u202f×\u202f12\u202fmin/wk', '8-10-year-old children', '8-10-year-old healthy Danish schoolchildren (n\u202f=\u202f232', 'healthy children']","['small-sided games group (SSG, n\u202f=\u202f60), an interval running group (IR, n\u202f=\u202f57) or a control group (CON', 'intense school-based physical training', 'intense physical training, including small-sided ball games (soccer, basketball and floorball) or interval running']","['delta scores for diastolic blood pressure (BP) and mean arterial BP', 'Cardiovascular adaptations', 'diastolic BP', 'Delta scores', 'mean arterial BP', 'Comprehensive transthoracic echocardiography, resting heart rate and blood pressure measurements', 'delta scores', 'interventricular septum thickness and peak transmitral flow velocity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030895', 'cui_str': 'Sodium Stibogluconate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0225870', 'cui_str': 'Interventricular septum structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.050631,"Moreover, there were between-group differences in delta scores (P < 0.05) for selected echocardiographic parameters, i.e. in SSG vs. CON for interventricular septum thickness and peak transmitral flow velocity in early diastole, and in IR vs. CON for left ventricular systolic diameter.","[{'ForeName': 'Malte Nejst', 'Initials': 'MN', 'LastName': 'Larsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark; Department of Nutrition, Exercise and Sports, Copenhagen Centre for Team Sport and Health, University of Copenhagen, Copenhagen, Denmark. Electronic address: mnlarsen@health.sdu.dk.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Madsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Claus Malta', 'Initials': 'CM', 'LastName': 'Nielsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen Centre for Team Sport and Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Manniche', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen Centre for Team Sport and Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Hansen', 'Affiliation': 'Team Denmark, Brøndby, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen Centre for Team Sport and Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark; Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Peter Riis', 'Initials': 'PR', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte University Hospital, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.05.011']
2708,32497599,"Efficacy and safety of MT10107 (Coretox®) in post-stroke upper limb spasticity treatment: A randomized, double-blind, active drug-controlled, multi-center, phase III clinical trial.","OBJECTIVE
To compare the efficacy and safety of MT10107 (Coretox®) with those of onabotulinum toxin A (Botox®) in patients with post-stroke upper limb spasticity DESIGN: A prospective, randomized, double-blind, active drug-controlled, multi-center, phase III clinical trial SETTING: Seven university hospitals in the Republic of Korea PARTICIPANTS: A total of 220 patients with post-stroke upper limb spasticity INTERVENTIONS: All participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group).
MAIN OUTCOME MEASURES
The primary outcome was change in wrist flexor spasticity from baseline to week 4 and was assessed using the modified Ashworth scale (MAS). The secondary outcomes were MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment. Safety was evaluated based on adverse events, vital signs, physical examination findings, and laboratory test results. The efficacy and safety were evaluated at 4, 8, and 12 weeks post-intervention.
RESULTS
The primary outcome was found to be -1.32 ± 0.69 and -1.40 ± 0.69 for the Coretox and Botox groups, respectively. MT10107 showed a non-inferior efficacy compared with onabotulinum toxin A, as the 95% confidence interval for between-group differences was -0.10 to 0.27 and the upper limit was less than the non-inferiority margin of 0.45. Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference. No significant between-group differences were observed regarding response rate, global assessment of treatment, and safety measures.
CONCLUSIONS
MT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in post-stroke upper limb spasticity treatment.",2020,"Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference.","['post-stroke upper limb spasticity treatment', '220 patients with post-stroke upper limb spasticity', 'Seven university hospitals in the Republic of Korea PARTICIPANTS', 'patients with post-stroke upper limb spasticity DESIGN']","['onabotulinum toxin A (Botox®', 'MT10107 (Coretox group) or onabotulinum toxin A (Botox group', 'MT10107 (Coretox®']","['modified Ashworth scale (MAS', 'adverse events, vital signs, physical examination findings, and laboratory test results', 'Efficacy and safety', 'MAS scores for all muscles and DAS scores', 'response rate, global assessment of treatment, and safety measures', 'change in wrist flexor spasticity', 'efficacy and safety', 'MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C4743433', 'cui_str': 'onabotulinum toxin A'}, {'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",220.0,0.288437,"Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference.","[{'ForeName': 'Junekyung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min Ho', 'Initials': 'MH', 'LastName': 'Chun', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: mhchun@amc.seoul.kr.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Ko', 'Affiliation': ""Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Shi-Uk', 'Initials': 'SU', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Deog Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Bum Sun', 'Initials': 'BS', 'LastName': 'Kwon', 'Affiliation': 'Department of Rehabilitation Medicine, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Yoon Ghil', 'Initials': 'YG', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Gangnam Severance Hospital Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.025']
2709,32497605,The duration of intrapartum supplemental oxygen administration and umbilical cord oxygen content.,"OBJECTIVE
We tested the hypothesis that a longer duration of supplemental oxygen (O 2 ) exposure in labor is associated with higher umbilical cord O 2 content.
STUDY DESIGN
This is a planned secondary analysis of a randomized noninferiority trial comparing O 2 to room air (RA) in laboring patients. Patients were randomized to 10 L/min O 2 or RA at any point in active labor when they developed a Category II tracing that otherwise required resuscitation. The primary outcome for this analysis was umbilical vein (UV) pO 2 . The secondary outcome was umbilical artery (UA) pO 2 . These outcomes were compared between patients with short and long durations of O 2 exposure, defined as <75 th percentile and ≥75 th percentile of duration, respectively. Outcomes were also compared between RA, short O 2 , and long O 2 groups.
RESULTS
Among the 99 patients with paired and validated cord gases included in this analysis, UV pO 2 was significantly lower in patients who received longer durations of O 2 compared to those who received shorter durations (median [IQR] 25.5[21.5,33] vs 32.5 [26.5, 37.5] mm Hg, p 0.03). There was no difference in UA pO 2 or other cord gases between short and long duration O 2 groups. Other methods of intrauterine resuscitation were similar between short and long duration O 2 groups. There was no difference in UA or UV pO 2 when compared between RA, short duration O 2 , and long duration O 2 groups.
CONCLUSION
Long durations of O 2 exposure are not associated with higher cord pO 2 . In fact, patients with longer O 2 exposure had lower UV pO 2 , suggesting impaired placental O 2 transfer with prolonged O 2 exposure.",2020,"There was no difference in UA or UV pO 2 when compared between RA, short duration O 2 , and long duration O 2 groups.
",['laboring patients'],[],"['umbilical vein (UV) pO 2 ', 'duration of intrapartum supplemental oxygen administration and umbilical cord oxygen content', 'UA pO 2 or other cord gases', 'umbilical artery (UA) pO 2 ']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0041637', 'cui_str': 'Structure of umbilical vein'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0523806', 'cui_str': 'Oxygen measurement'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}]",99.0,0.283401,"There was no difference in UA or UV pO 2 when compared between RA, short duration O 2 , and long duration O 2 groups.
","[{'ForeName': 'Virginia Y', 'Initials': 'VY', 'LastName': 'Watkins', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO. Electronic address: Watkinsv@wustl.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas at Austin, Dell Medical School.'}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas at Austin, Dell Medical School.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.056']
2710,32497693,Habit Tracking of Sunscreen Use in NCAA Cross Country Athletes: A Randomized Pilot Study.,,2020,,['NCAA Cross Country Athletes'],[],[],"[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],[],,0.030267,,"[{'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'List', 'Affiliation': 'The Christ Hospital, Department of Internal Medicine, Resident, 2139 Auburn Avenue, Cincinnati, OH 45219.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Carter', 'Affiliation': 'University of Louisville, School of Medicine, Department of Global Education, GEO Assistant Director, 500 South Preston Street, Suite 305, Louisville, KY 40202.'}, {'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Adams', 'Affiliation': 'University of Cincinnati, College of Medicine, Department of Dermatology, Chair and Professor of Dermatology, 3230 Eden Avenue, Cincinnati, OH 45267.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.05.108']
2711,32497714,The effect of acupressure on the severity of pruritus and laboratory parameters in patients undergoing hemodialysis: A randomized clinical trail.,"OBJECTIVES
The aim of this study is to determine the effect of acupressure on the severity of pruritus and some laboratory parameters in patients undergoing hemodialysis.
MATERIALS AND METHODS
The present clinical trial was conducted on 90 hemodialysis patients. Pressure was applied on SP6, SP10, ST36, and LI11 points in the intervention group and on ineffective points for the sham control group. The severity of itching was measured using the Numeric Rating Scale.
RESULTS
There was a significant reduction in the severity of pruritus over the course of the study in the intervention and sham control groups (P=0.001). Also significant differences were observed at the end of the intervention in terms of serum phosphorus (P=0.045) and parathyroid hormone (P=0.004) levels between groups.
CONCLUSION
Acupressure can improve the severity of pruritus dramatically in hemodialysis patients, but has no effect on laboratory parameters, except for serum phosphorus and parathyroid hormone levels.",2020,"Also significant differences were observed at the end of the intervention in terms of serum phosphorus (P=0.045) and parathyroid hormone (P=0.004) levels between groups.
","['90 hemodialysis patients', 'patients undergoing hemodialysis', 'hemodialysis patients']","['Acupressure', 'acupressure']","['severity of itching', 'severity of pruritus', 'serum phosphorus', 'severity of pruritus and laboratory parameters', 'Numeric Rating Scale', 'serum phosphorus and parathyroid hormone levels', 'parathyroid hormone']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",90.0,0.0372002,"Also significant differences were observed at the end of the intervention in terms of serum phosphorus (P=0.045) and parathyroid hormone (P=0.004) levels between groups.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Karjalian', 'Affiliation': 'Student research committee, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: karjalian1990@gmail.com.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Momennasab', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: momennasab@sums.ac.ir.'}, {'ForeName': 'Amin Kordi', 'Initials': 'AK', 'LastName': 'Yoosefinejad', 'Affiliation': 'Physical therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: yoosefinejad@sums.ac.ir.'}, {'ForeName': 'Shahrokh Ezzatzadegan', 'Initials': 'SE', 'LastName': 'Jahromi', 'Affiliation': 'Nephrology-urology research center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: shahrokhjahromi@gmail.com.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.05.002']
2712,32497736,Trifluridine/Tipiracil plus Bevacizumab in Patients with Untreated Metastatic Colorectal Cancer Ineligible for Intensive Therapy: the Randomized TASCO1 Study.,"PURPOSE
We designed an open-label, non-comparative phase II study to assess the safety and efficacy of first-line treatment with trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B) in untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies.
PATIENTS AND METHODS
From 29 April 2016 to 29 March 2017, 153 patients were randomly assigned (1:1) to either TT-B (n=77) or C-B (n=76). The primary endpoint was progression-free survival (PFS). The primary PFS analysis was performed after 100 events (radiological progression or death) were observed. Secondary endpoints included overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires) and safety.
RESULTS
Median duration of treatment was 7.8 [6.0;9.7] months and 6.2 [4.1;9.1] months in the TT-B and C-B groups, respectively. Median PFS was 9.2 [7.6;11.6] and 7.8 [5.5;10.1] months, respectively. Median OS was 18 [15.2;NA] and 16.2 [12.5;NA] months, respectively. QoL questionnaires showed no relevant changes over time for either treatment. Therapies were well tolerated. Patients receiving TT-B had more grade ≥3 neutropenia (47% vs. 5% with C-B). Patients receiving C-B had more grade ≥3 hand-foot syndrome (12% vs. 0% with TT-B) and grade ≥3 diarrhea (8% vs. 1% with TT-B), consistent with the known safety profiles of these agents.
CONCLUSION
TT-B treatment showed promising clinical activity in untreated patients with unresectable mCRC ineligible for intensive therapy, with an acceptable safety profile and no clinically relevant changes in QoL.",2020,Patients receiving TT-B had more grade ≥3 neutropenia (47% vs. 5% with C-B).,"['Patients with Untreated Metastatic Colorectal Cancer Ineligible for Intensive Therapy', 'From 29 April 2016 to 29 March 2017', 'untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies', '153 patients']","['Trifluridine/Tipiracil plus Bevacizumab', 'trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B']","['grade ≥3 hand-foot syndrome', 'Median PFS', 'Median OS', 'tolerated', 'overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires) and safety', '100 events (radiological progression or death', 'clinical activity', 'grade ≥3 diarrhea', 'safety and efficacy', 'grade ≥3 neutropenia', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",153.0,0.0974354,Patients receiving TT-B had more grade ≥3 neutropenia (47% vs. 5% with C-B).,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Leuven and KU Leuven, Leuven, Belgium. Electronic address: eric.vancutsem@uzleuven.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Danielewicz', 'Affiliation': 'Szpitale Wojewodzkie w Gdyni/Gdansk Medical University, Gdynia, Poland.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Argilés', 'Affiliation': ""Vall d'Hebrón Institute of Oncology and Vall d'Hebrón University Hospital, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'University Hospital Besançon, Besançon, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'C J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Van de Wouw', 'Affiliation': 'VieCuri Medisch Centrum Noord-Limburg, Venlo, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fedyanin', 'Affiliation': 'NN Blokhin National Medical Research Center of Oncology, Moscow, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital N62, Moscow, Russia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kroening', 'Affiliation': 'Schwerpunktpraxis für Haematologie und Onkologie Hasselbachplatz 2 39104, Magdeburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Garcia-Alfonso', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial college London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'University Hospital of Pisa, Department of Oncology, Pisa, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kanehisa', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Egorov', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Aubel', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Amellal', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moiseenko', 'Affiliation': 'Saint-Petersburg Scientific Practical Center for Specialized Medical Care, St Petersburg, Russia.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.024']
2713,32497779,"Effects of a synbiotic on symptoms, and daily functioning in Attention deficit hyperactivity disorder - a double-blind randomized controlled trial.","Some prebiotics and probiotics have been proposed to improve psychiatric symptoms in children with autism. However, few studies were placebo-controlled, and there is no study on persons with an attention deficit hyperactivity disorder (ADHD) diagnosis. Our aim was to study effects of Synbiotic 2000 on psychiatric symptoms and functioning in children and adults with ADHD without an autism diagnosis. Children and adults (n=182) with an ADHD diagnosis completed the nine weeks randomized double-blind parallel placebo-controlled trial examining effects of Synbiotic 2000 on the primary endpoints ADHD symptoms, autism symptoms and daily functioning, and the secondary endpoint emotion regulation, measured using the questionnaires SNAP-IV, ASRS, WFIRS, SCQ, AQ and DERS-16. Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery. Synbiotic 2000 and placebo improved ADHD symptoms equally well, and neither active treatment nor placebo had any statistically significant effect on functioning or sub-diagnostic autism symptoms. However, Synbiotic 2000, specifically, reduced sub-diagnostic autism symptoms in the domain restricted, repetitive and stereotyped behaviors in children, and improved emotion regulation in the domain of goal-directed behavior in adults. In children with elevated sVCAM-1 levels at baseline as well as in children without ADHD medication, Synbiotic 2000 reduced both the total score of autism symptoms, and the restricted, repetitive and stereotyped behaviors. In adults with elevated sVCAM-1 at baseline, Synbiotic 2000 significantly improved emotion regulation, both the total score and four of the five subdomains. To conclude, while no definite Synbiotic 2000-specific effect was detected, the analysis of those with elevated plasma sVCAM-1 levels proposed a reduction of autism symptoms in children and an improvement of emotion regulation in adults with ADHD. Trial registration number: ISRCTN57795429.",2020,"Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery.","['children with autism', 'persons with an attention deficit hyperactivity disorder (ADHD) diagnosis', 'children and adults with ADHD without an autism diagnosis', 'Children and adults (n=182) with an ADHD diagnosis', 'Attention deficit hyperactivity disorder ', 'adults with ADHD']","['placebo', 'Synbiotic 2000 and placebo', 'Synbiotic 2000', 'synbiotic']","['psychiatric symptoms and functioning', 'plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses', 'emotion regulation', 'total score of autism symptoms', 'reduced sub-diagnostic autism symptoms', 'elevated sVCAM-1 levels', 'ADHD symptoms, autism symptoms and daily functioning, and the secondary endpoint emotion regulation, measured using the questionnaires SNAP-IV, ASRS, WFIRS, SCQ, AQ and DERS-16', 'ADHD symptoms', 'functioning or sub-diagnostic autism symptoms', 'psychiatric symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1177045', 'cui_str': 'Snap'}]",,0.53757,"Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery.","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Skott', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden; PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Liu L', 'Initials': 'LL', 'LastName': 'Yang', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Stiernborg', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Söderström', 'Affiliation': 'PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Ruegg', 'Affiliation': 'Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden; Uppsala University, Department of Organismal Biology, Uppsala, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schalling', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Forsell', 'Affiliation': 'Karolinska Institutet, Department of Global Public Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'MaiBritt', 'Initials': 'M', 'LastName': 'Giacobini', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Lavebratt', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden. Electronic address: catharina.lavebratt@ki.se.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.05.056']
2714,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND
There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM).
METHODS
In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
RESULTS
At least 296 participants and approximately 75 peer supporters will be enrolled.
DISCUSSION
Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes.
TRIAL REGISTRATION
The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina Alvarado', 'Initials': 'CA', 'LastName': 'Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048']
2715,32497906,Radial versus femoral artery access for percutaneous coronary artery intervention in patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock: Subanalysis from the CULPRIT-SHOCK trial.,"BACKGROUND
The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear.
METHODS
This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes.
RESULTS
Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively).
CONCLUSIONS
In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.",2020,No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke.,"['patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock', 'patients undergoing', 'patients presenting with MI and multivessel disease complicated by CS']","['Radial versus femoral artery access', 'percutaneous coronary intervention (PCI', 'transradial artery access (TRA', 'percutaneous coronary artery intervention', 'transfemoral artery access (TFA']","['TRA and TFA', '30-day rate of death', '30-day rate of RRT', '30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke', 'death or RRT and death with TRA', '30-day rate of death or RRT', 'composite of death or renal replacement therapy (RRT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",673.0,0.38324,No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barthélémy', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rouanet', 'Affiliation': 'Statistician unit, StatEthic, Levallois-Perret, France.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung and Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.014']
2716,32497927,Influence of type 1 diabetes on the postural control of women in the third gestational trimester.,"BACKGROUND
Diabetes can cause biomechanical alterations that may be responsible for additional changes to those existing in a regular gestational period. The way a maternal body responds when affected by diabetes has not been clearly understood. This study aimed to describe the influence of type 1 diabetes on pregnant women's postural control.
METHODS
Forty pregnant women in their third gestational trimester were allocated in two equal groups - the control group and the type 1 diabetic group. The variables related to postural control and balance were assessed using photogrammetry (head protrusion; cervical lordosis; thoracic kyphosis; lumbar lordosis; pelvic anteversion, knee flexion, tibiotarsal and foot inclination angles were measured), and baropodometry (anteroposterior and mediolateral distance trajectory of the center of pressure, amplitude and average speed of displacement of the center of pressure).
FINDINGS
The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles. In the baropodometry, the anteroposterior distance and the amplitude of the center of pressure displacement with eyes open and closed were higher.
INTERPRETATION
The findings suggest that type 1 diabetes mellitus in the third trimester of pregnancy is associated with postural changes, a decrease in the active ankle range of motion and increase in the anteroposterior oscillation of the center of pressure, with negative repercussions for postural control.",2020,"The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles.","['Forty pregnant women in their third gestational trimester', 'women in the third gestational trimester', ""pregnant women's postural control""]",[],"['postural analysis, lower head protrusion and pelvic anteversion angles', 'postural control and balance were assessed using photogrammetry (head protrusion; cervical lordosis; thoracic kyphosis; lumbar lordosis; pelvic anteversion, knee flexion, tibiotarsal and foot inclination angles were measured), and baropodometry (anteroposterior and mediolateral distance trajectory of the center of pressure, amplitude and average speed of displacement of the center of pressure', 'cervical lordosis, thoracic kyphosis, and lumbar lordosis angles']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",[],"[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031747', 'cui_str': 'Photogrammetry'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024003', 'cui_str': 'Lordosis accentuated'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C1184923', 'cui_str': 'Lumbar hyperlordosis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",40.0,0.0325439,"The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles.","[{'ForeName': 'Paola Marini', 'Initials': 'PM', 'LastName': 'Valerio', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: paola.marini@usp.br.'}, {'ForeName': 'Vanessa Ellen', 'Initials': 'VE', 'LastName': 'Gonçalves', 'Affiliation': 'Physical Therapy Course, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: vanessa.ellen.goncalves@usp.br.'}, {'ForeName': 'Catarina Clapis', 'Initials': 'CC', 'LastName': 'Zordão', 'Affiliation': 'Physical Therapy Course, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: catarina.zordao@usp.br.'}, {'ForeName': 'Monique Silva', 'Initials': 'MS', 'LastName': 'Rezende', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: moniquerezende@usp.br.'}, {'ForeName': 'Elaine Christine Dantas', 'Initials': 'ECD', 'LastName': 'Moisés', 'Affiliation': 'Postgraduate Program in Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: elainemoises@fmrp.usp.br.'}, {'ForeName': 'Elaine Caldeira de Olveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105062']
2717,31433489,The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care.,,2019,,[],[],[],[],[],[],,0.0285485,,"[{'ForeName': 'Tien M', 'Initials': 'TM', 'LastName': 'Truong', 'Affiliation': 'Committee on Clinical Pharmacology and Pharmacogenomics, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Apfelbaum', 'Affiliation': 'Department of Anesthesia and Critical Care, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Sajid', 'Initials': 'S', 'LastName': 'Shahul', 'Affiliation': 'Department of Anesthesia and Critical Care, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Anitescu', 'Affiliation': 'Department of Anesthesia and Critical Care, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Danahey', 'Affiliation': 'Center for Personalized Therapeutics, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Randall W', 'Initials': 'RW', 'LastName': 'Knoebel', 'Affiliation': 'Department of Pharmacy, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liebovitz', 'Affiliation': 'Department of Medicine, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Karrison', 'Affiliation': 'Department of Public Health Sciences, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Xander M R', 'Initials': 'XMR', 'LastName': 'van Wijk', 'Affiliation': 'Committee on Clinical Pharmacology and Pharmacogenomics, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Kiang-Teck J', 'Initials': 'KJ', 'LastName': 'Yeo', 'Affiliation': 'Committee on Clinical Pharmacology and Pharmacogenomics, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meltzer', 'Affiliation': 'Department of Medicine, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'Committee on Clinical Pharmacology and Pharmacogenomics, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': ""O'Donnell"", 'Affiliation': 'Committee on Clinical Pharmacology and Pharmacogenomics, The University of Chicago, Chicago, Illinois, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1567']
2718,31808664,Changes in plasma volume before and after major abdominal surgery following stroke volume variation-guided fluid therapy: a randomized controlled trial.,"BACKGROUND
The aim of intraoperative fluid therapy is to avoid both hypovolemia and hypervolemia; however, the patient's exact volume status is difficult to determine during surgery. Fluid optimization guided by stroke volume variation (SVV) has been widely used in patients undergoing major open abdominal surgery. The aim of this study was to evaluate the changes in plasma volume before and after surgery following SVV-guided fluid therapy.
METHODS
Patients were randomly allocated into one of two groups according to the SVV criteria for fluid administration during surgery. In the fixed SVV fluid strategy group, fluid was administered to maintain the SVV below 13%. In the individual SVV group, individual SVV values of each patient were maintained until the end of surgery. Plasma volume, body weight, and extracellular water (ECW) were measured before and after surgery. Plasma volume was estimated using the indocyanine green dilution technique.
RESULTS
A total of 118 patients were included. Median (25-75%) plasma volumes in the preoperative and postoperative period were 2.46 (2.20-2.88) L and 2.69 (2.33-3.12) L for the fixed SVV group (N.=57, P=0.133), respectively, and 2.56 (2.23-2.90) L and 2.89 (2.48-3.19) L for the individual SVV group (N.=61, P<0.001), respectively.
CONCLUSIONS
Fluid administration during surgery to maintain SVV below 13% was effective for maintaining the preoperative plasma volume until the end of surgery in patients undergoing major open stomach or colorectal surgery. This result supports the validity of SVV-guided fluid therapy, which maintains the SVV value below 13%, in terms of maintaining patient volume status.",2020,"(2.48-3.19) L for the individual SVV group (N.=61, P<0.001), respectively.
","['A total of 118 patients were included', 'patients undergoing major open stomach or colorectal surgery', 'patients undergoing major open abdominal surgery', 'Patients']","['SVV-guided fluid therapy', 'intraoperative fluid therapy', 'Fluid optimization guided by stroke volume variation (SVV']","['Plasma volume, body weight, and extracellular water (ECW', 'plasma volume', 'individual SVV values', 'Plasma volume', 'plasma volumes']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]","[{'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",118.0,0.0506117,"(2.48-3.19) L for the individual SVV group (N.=61, P<0.001), respectively.
","[{'ForeName': 'Yong-Hun', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hye-Won', 'Initials': 'HW', 'LastName': 'Jang', 'Affiliation': 'University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chan-Hye', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang-Mee', 'Initials': 'SM', 'LastName': 'An', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eun-Kyoung', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Byung-Moon', 'Initials': 'BM', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Gyu-Jeong', 'Initials': 'GJ', 'LastName': 'Noh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea - nohgj@amc.seoul.kr.'}]",Minerva anestesiologica,['10.23736/S0375-9393.19.13952-1']
2719,31830830,Effect of Blood Flow Restricted Resistance Exercise and Remote Ischemic Conditioning on Functional Capacity and Myocellular Adaptations in Patients With Heart Failure.,"BACKGROUND
Patients with congestive heart failure (CHF) have impaired functional capacity and inferior quality of life. The clinical manifestations are associated with structural and functional impairments in skeletal muscle, emphasizing a need for feasible rehabilitation strategies beyond optimal anticongestive medical treatment. We investigated whether low-load blood flow restricted resistance exercise (BFRRE) or remote ischemic conditioning (RIC) could improve functional capacity and quality of life in patients with CHF and stimulate skeletal muscle myofibrillar and mitochondrial adaptations.
METHODS
We randomized 36 patients with CHF to BFRRE, RIC, or nontreatment control. BFRRE and RIC were performed 3× per week for 6 weeks. Before and after intervention, muscle biopsies, tests of functional capacity, and quality of life assessments were performed. Deuterium oxide was administered throughout the intervention to measure cumulative RNA and subfraction protein synthesis. Changes in muscle fiber morphology and mitochondrial respiratory function were also assessed.
RESULTS
BFRRE improved 6-minute walk test by 39.0 m (CI, 7.0-71.1, P =0.019) compared with control. BFRRE increased maximum isometric strength by 29.7 Nm (CI, 10.8-48.6, P =0.003) compared with control. BFRRE improved quality of life by 5.4 points (CI, -0.04 to 10.9; P =0.052) compared with control. BFRRE increased mitochondrial function by 19.1 pmol/s per milligram (CI, 7.3-30.8; P =0.002) compared with control. RIC did not produce similar changes.
CONCLUSIONS
Our results demonstrate that BFRRE, but not RIC, improves functional capacity, quality of life, and muscle mitochondrial function. Our findings have clinical implications for rehabilitation of patients with CHF and provide new insights on the myopathy accompanying CHF.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT03380663.",2019,"BFRRE improved quality of life by 5.4 points (CI, -0.04 to 10.9; P =0.052) compared with control.","['36 patients with CHF to BFRRE, RIC, or nontreatment control', 'patients with CHF and stimulate skeletal muscle myofibrillar and mitochondrial adaptations', 'Patients with congestive heart failure (CHF', 'Patients With Heart Failure']","['Deuterium oxide', 'low-load blood flow restricted resistance exercise (BFRRE) or remote ischemic conditioning (RIC', 'Blood Flow Restricted Resistance Exercise and Remote Ischemic Conditioning']","['BFRRE increased mitochondrial function', 'BFRRE improved 6-minute walk test', 'BFRRE improved quality of life', 'muscle biopsies, tests of functional capacity, and quality of life assessments', 'functional capacity and quality of life', 'maximum isometric strength', 'BFRRE and RIC', 'functional capacity, quality of life, and muscle mitochondrial function', 'Functional Capacity and Myocellular Adaptations', 'muscle fiber morphology and mitochondrial respiratory function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0011745', 'cui_str': 'Deuterium oxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",36.0,0.0478746,"BFRRE improved quality of life by 5.4 points (CI, -0.04 to 10.9; P =0.052) compared with control.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Groennebaek', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sieljacks', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Pryds', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Nichlas R', 'Initials': 'NR', 'LastName': 'Jespersen', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Carlsen', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Frank V', 'Initials': 'FV', 'LastName': 'de Paoli', 'Affiliation': 'Department of Biomedicine (F.V.d.P.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Miller', 'Affiliation': 'Aging and Metabolism Research Program, Oklahoma Medical Research Foundation, Oklahoma City (B.F.M.).'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Vissing', 'Affiliation': 'Section for Sports Science, Department of Public Health, Aarhus University, Aarhus, Denmark (T.G., P.S., J.W., C.R.C., K.V.).'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology (R.N., K.P., N.R.J., M.R.S., H.E.B.), Aarhus University Hospital, Denmark.'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006427']
2720,32499312,The Diet of Higher Insulinemic Potential Is Not Associated with Worse Survival in Patients with Stage III Colon Cancer (Alliance).,"BACKGROUND
Hyperinsulinemia is considered to be important in the development of colon cancer, but few studies have investigated the associations of hyperinsulinemia with colon cancer survival via dietary scores.
METHODS
Empirical dietary index for hyperinsulinemia (EDIH) was derived to assess the insulinemic potential of daily diets reflecting the long-term insulin exposure, with higher (more positive) scores indicating higher insulinemic diets. We prospectively estimated the hazard ratios (HR) and 95% confidence intervals (CI) to investigate the association of EDIH with disease-free, recurrence-free, and overall survival among patients with stage III colon cancer (1999-2009) enrolled in a randomized adjuvant chemotherapy trial (CALGB 89803).
RESULTS
Of 1,024 patients (median follow-up: 7.3 years), 311 died, 350 had recurrences, and 394 had events for disease-free survival. Compared with patients in the lowest quintile of EDIH, the corresponding HRs of patients in the highest quintile for disease-free survival events, cancer recurrence, and overall mortality were 0.80 (95% CI, 0.56-1.15), 0.76 (95% CI, 0.51-1.11), and 0.77 (95% CI, 0.52-1.14).
CONCLUSIONS
Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of stage III colon cancer patients.
IMPACT
EDIH, as a measure of dietary insulinemic potential, may be associated with colon cancer risk, but not survival in late stage colon cancer patients.",2020,"CONCLUSIONS
Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of stage III colon cancer patients.
","['late stage colon cancer patients', 'Patients with Stage III Colon Cancer (Alliance', 'patients with stage III colon cancer (1999-2009) enrolled in a randomized adjuvant chemotherapy trial (CALGB 89803', 'stage III colon cancer patients']",[],"['hazard ratios (HR', 'risk of colon cancer recurrence or mortality', 'EDIH with disease-free, recurrence-free, and overall survival', 'disease-free survival', 'disease-free survival events, cancer recurrence, and overall mortality']","[{'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",,0.343602,"CONCLUSIONS
Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of stage III colon cancer patients.
","[{'ForeName': 'En', 'Initials': 'E', 'LastName': 'Cheng', 'Affiliation': 'Chronic Disease Epidemiology, Yale University.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mullen', 'Affiliation': 'Alliance Statistics and Data Management Center.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Saltz', 'Affiliation': 'Medicine, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwieck', 'Affiliation': 'Duke University School of Medicine.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Rex B', 'Initials': 'RB', 'LastName': 'Mowat', 'Affiliation': 'Oncology, Toledo Community Hospital Oncology Program CCOPO.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Whittom', 'Affiliation': 'Medicine, Hôpital du Sacré-Coeur de Montréal.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hantel', 'Affiliation': 'Medicine, Loyola University, Stritch School of Medicine.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Atienza', 'Affiliation': 'Virginia Oncology Associates.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Messino', 'Affiliation': 'Southeast Clinical Oncology Research Consortium.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kindler', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center and Biological Sciences.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Epidemiology & Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine charles.fuchs@yale.edu.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1454']
2721,32499466,The efficacy of two doses versus 7 days' course of prophylactic antibiotics following cesarean section: An experience from Aminu Kano Teaching Hospital.,"Background
Postcesarean wound infection is a leading cause of prolonged hospital stay. Considerable debates still exist regarding choice of antibiotics, dose, and duration of use.
Objectives
The objective is to compare the efficacy of 2 doses of amoxicillin-clavulanic acid versus a 7 days combination of amoxicillin-clavulanic acid and metronidazole as prophylactic antibiotics following cesarean section (CS).
Methodology
It was a randomized controlled trial that was conducted among 160 women undergoing CS at Aminu Kano Teaching Hospital. Women were randomized into two groups. Group I (study group) received 2 doses of 1.2 g amoxicillin-clavulanic acid. Group II (control group) received a 7 days course of amoxicillin-clavulanic acid and metronidazole. The data obtained were analyzed using SPSS version 17. Categorical (qualitative) variables were analyzed using Chi-square test and Fisher's exact test as appropriate while continuous (quantitative) variables were analyzed using independent sample t-test. P < 0.05 was considered statistically significant.
Results
There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups. There was statistically significant difference in the mean cost of antibiotics (₦2883/US$9.5 vs. ₦7040/US$23.1, P < 0.001) and maternal side effects (10.3% vs. 26.3%, P < 0.001) between the study and the control groups, respectively.
Conclusion
This study found no statistically significant difference in infectious morbidity, duration of hospital stay, and neonatal outcomes when two doses of amoxicillin-clavulanic acid was compared with a 7 days course of prophylactic antibiotic following CS. The use of two doses of amoxicillin-clavulanic acid has the advantages of reduced cost and some maternal side effects. The two doses were cheaper with minimal side effects.",2020,"There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups.","['160 women undergoing CS at Aminu Kano Teaching Hospital', 'cesarean section']","['prophylactic antibiotics', 'amoxicillin-clavulanic acid', 'amoxicillin-clavulanic acid and metronidazole']","['mean duration of hospital stay', 'occurrence of fever', 'mean cost of antibiotics', 'wound infection', 'infectious morbidity, duration of hospital stay, and neonatal outcomes', 'endometritis', 'maternal side effects', 'neonatal outcomes']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",160.0,0.0917406,"There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups.","[{'ForeName': 'Salihu Ozegya', 'Initials': 'SO', 'LastName': 'Mohammed', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Samaila Danjuma', 'Initials': 'SD', 'LastName': 'A Shuaibu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Sule Abdullahi', 'Initials': 'SA', 'LastName': 'Gaya', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Ayyuba', 'Initials': 'A', 'LastName': 'Rabiu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.'}]",Annals of African medicine,['10.4103/aam.aam_39_19']
2722,32499471,The effect of combination of warm intravenous fluid infusion and forced air warming versus forced air warming alone on maternal temperature and shivering during cesarian delivery under spinal anesthesia.,"Objective
Administration of warm intravenous (IV) fluid infusion and use of forced air warmers is the most easy and physiologically viable method for maintaining normothermia during surgery and postsurgical periods This study was conducted to assess the effect of combination of active warming (AW) methods namely warm IV fluid infusion and forced air warming versus forced air warming only (WA) on maternal temperature during elective C-delivery under spinal anesthesia.
Materials and Methods
A total of 100 patients scheduled for elective c-section were grouped into those who received both warmed IV fluid infusion and forced air warmer (Combination of active warming WI= 50) and those who received only forced air warmer (WA = 50). Core body temperature and shivering incidence were recorded using a tympanic thermometer from prespinal till the end of surgery every 10 min and in postanesthesia care unit (PACU) at 0, 15, and 30 min.
Results
Core temperature showed statistically significant difference in 15, 35, 45, and 55 min between air warmer and warm infusion groups and in PACU at 0, 15, and 30 min, it was statistically significant (P = 0.000) among WI group (mean temperature = 36.79°C) when compared to WA group (mean temperature = 35.96°C). There was a lower incidence of shivering in WI compared to WA group, which is statistically significant.
Conclusion
Combination of warm Intravenous fluid infusion and Forced air warming is better than forced air warming alone. In maintaining near normal maternal core body temperature during elective cesarean section following spinal anesthesia. Combined warming method also reduces shivering incidence.",2020,"There was a lower incidence of shivering in WI compared to WA group, which is statistically significant.
","['maternal temperature and shivering during cesarian delivery under spinal anesthesia', '100 patients scheduled for elective c-section']","['warm intravenous fluid infusion and forced air warming versus forced air warming alone', 'warm intravenous (IV) fluid infusion', 'warmed IV fluid infusion and forced air warmer (Combination of active warming WI= 50) and those who received only forced air warmer', 'active warming (AW) methods namely warm IV fluid infusion and forced air warming versus forced air warming only (WA']","['Core body temperature and shivering incidence', 'incidence of shivering', 'shivering incidence']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",100.0,0.0345044,"There was a lower incidence of shivering in WI compared to WA group, which is statistically significant.
","[{'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Meghana', 'Affiliation': 'Department of Anaesthesia, KMC Mangalore, Manipal Academy of Higher Education, Mangalore, Karnataka, India.'}, {'ForeName': 'Sunil Baikadi', 'Initials': 'SB', 'LastName': 'Vasudevarao', 'Affiliation': 'Department of Anaesthesia, KMC Mangalore, Manipal Academy of Higher Education, Mangalore, Karnataka, India.'}, {'ForeName': 'Shaila S', 'Initials': 'SS', 'LastName': 'Kamath', 'Affiliation': 'Department of Anaesthesia, KMC Mangalore, Manipal Academy of Higher Education, Mangalore, Karnataka, India.'}]",Annals of African medicine,['10.4103/aam.aam_58_19']
2723,32499503,Reconsolidation-based treatment for fear of public speaking: a systematic pilot study using propranolol.,"Pharmacological manipulation of memory reconsolidation opens up promising new avenues for anxiety disorder treatment. However, few studies have directly investigated reconsolidation-based approaches in subclinical or clinical populations, leaving optimal means of fear memory reactivation unknown. We conducted a systematic pilot study to assess whether a reconsolidation-based treatment could tackle public speaking anxiety in a subclinical sample (N = 60). As lab studies indicate that the duration of reactivation may be important for inducing reconsolidation, we investigated several speech lengths to help inform further translational efforts. Participants underwent a stress-inducing speech task composed of 3-min preparation, and from 0 to 9 min of public speaking, in 1-min increments. They then received either 40 mg of propranolol (n = 40) or placebo (n = 20), double-blind, allocated 4:2 for each speech duration. Participants performed a second speech 1 week post treatment, and were followed up with questionnaires 1- and 3 months later. Both self-reported speech distress and questionnaire measures of public speaking anxiety showed clear reductions following treatment. However, propranolol did not reliably outperform placebo, regardless of speech duration at treatment. Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test. These findings highlight the challenges facing the translation of laboratory research on memory reconsolidation into clinical interventions. Lack of explicit controls for factors beyond duration, such as 'prediction error', could explain these null findings, but positive results in clinical interventions are needed to demonstrate that taking such factors into account can deliver the promises of reconsolidation-based therapy.",2020,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"['fear of public speaking', 'tackle public speaking anxiety in a subclinical sample (N\u2009=\u200960']","['stress-inducing speech task composed of 3-min preparation, and from 0 to 9\u2009min of public speaking', 'propranolol', 'placebo']",['Physiological responses (heart rate and salivary cortisol'],"[{'cui': 'C0424169', 'cui_str': 'Fear of public speaking'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392359', 'cui_str': 'Public Speaking'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0293513,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"[{'ForeName': 'James W B', 'Initials': 'JWB', 'LastName': 'Elsey', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands. j.w.b.elsey@uva.nl.'}, {'ForeName': 'Anna I', 'Initials': 'AI', 'LastName': 'Filmer', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harriet R', 'Initials': 'HR', 'LastName': 'Galvin', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Kurath', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vossoughi', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linnea S', 'Initials': 'LS', 'LastName': 'Thomander', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Zavodnik', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Kindt', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}]",Translational psychiatry,['10.1038/s41398-020-0857-z']
2724,32501761,"Open-label, randomised, multicentre crossover trial assessing two-layer compression bandaging for chronic venous insufficiency: results of the APRICOT trial.","Compression bandaging is the mainstay therapy for chronic venous insufficiency and venous leg ulcers, but patient compliance can be challenging due to associated discomfort. The study discussed here aimed to compare AndoFlex TLC Calamine and Coban2 compression bandaging in relation to patient comfort and pruritus symptomology, with severity of pruritus as the primary outcome. This was a multi-centre, prospective, non-blinded, randomised controlled crossover trial involving 39 randomised patients with chronic venous insufficiency patients. In two periods, the patients wore AndoFlex TLC Calamine or Coban2 for 3 weeks each. No significant differences in validated pruritus outcome measures were observed, including a non-significant treatment effect for the severity of pruritus scale (n=35 trial completers; p-value=0.24, Wilcoxon test). However, after trying both bandages, 21 of the 35 patients (60%) definitely preferred AndoFlex TLC Calamine, whereas 4 patients (11%) definitely preferred Coban2. Thus, AndoFlex TLC Calamine compression bandage therapy was preferred by most patients, although this observation could not be confirmed using validated patient-reported outcome measures for pruritus. Further research is indicated to establish if patient preference translates into favourable clinical outcomes. ISRCTN number: ISRCTN95282887.",2020,"No significant differences in validated pruritus outcome measures were observed, including a non-significant treatment effect for the severity of pruritus scale (n=35 trial completers; p-value=0.24, Wilcoxon test).","['chronic venous insufficiency', '39 randomised patients with chronic venous insufficiency patients']","['AndoFlex TLC Calamine and Coban2 compression bandaging', 'Compression bandaging', 'layer compression bandaging', 'AndoFlex TLC Calamine compression bandage therapy']",['severity of pruritus scale'],"[{'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0357929', 'cui_str': 'Calamine'}, {'cui': 'C1533146', 'cui_str': 'Compression bandaging'}, {'cui': 'C0677875', 'cui_str': 'Compression Bandage'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",39.0,0.098107,"No significant differences in validated pruritus outcome measures were observed, including a non-significant treatment effect for the severity of pruritus scale (n=35 trial completers; p-value=0.24, Wilcoxon test).","[{'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Jonker', 'Affiliation': 'Science and Innovation Manager, North Cumbria Integrated Care NHS Foundation Trust, Carlisle.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Todhunter', 'Affiliation': 'Specialist Vascular Nurse, North Cumbria Integrated Care NHS Trust.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Robinson', 'Affiliation': 'Specialist Vascular Nurse, North Cumbria Integrated Care NHS Trust.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Fisher', 'Affiliation': 'Research GP, North Cumbria Integrated Care NHS Trust.'}]",British journal of community nursing,['10.12968/bjcn.2020.25.Sup6.S6']
2725,32501774,Efficacy of Alcaftadine 0.25% (AGN-229666) for Once-daily Prevention of Cedar-Pollen Allergic Conjunctivitis: A Phase 3 Randomized Study.,"PURPOSE
This study evaluated the efficacy and safety of once-daily Alcaftadine 0.25% (AGN-229666) for prevention of signs and symptoms of Japanese cedar-pollen allergic conjunctivitis.
METHODS
This was a single-center, placebo-, and comparator-controlled study using the Ora-CAC® model of allergic conjunctivitis. The primary endpoint was ocular itching 16 hours after Alcaftadine 0.25% instillation; efficacy at 16 hours was compared with 0.1% Olopatadine, 4 hours after instillation. Secondary endpoints included conjunctival hyperemia.
RESULTS
263 Japanese subjects were enrolled; 224 completed the trial. Alcaftadine 0.25% was statistically superior to vehicle for relief of ocular itching at 16 hours ( p < .0001). Alcaftadine 0.25% at 16 hours was non-inferior to Olopatadine at 4 hours. Alcaftadine 0.25% was significantly better than vehicle for relief of conjunctival hyperemia. All treatments showed a low frequency of ocular adverse events.
CONCLUSION
Once-daily Alcaftadine 0.25% is safe and effective in preventing signs and symptoms of Japanese cedar-pollen allergic conjunctivitis.",2020,Alcaftadine 0.25% at 16 hours was non-inferior to Olopatadine at 4 hours.,"['263 Japanese subjects were enrolled; 224 completed the trial', 'allergic conjunctivitis', 'Japanese cedar-pollen allergic conjunctivitis', 'Cedar-Pollen Allergic Conjunctivitis']","['Olopatadine', 'Alcaftadine 0.25% (AGN-229666', 'Alcaftadine', 'placebo']","['relief of conjunctival hyperemia', 'low frequency of ocular adverse events', 'ocular itching 16\xa0hours after Alcaftadine 0.25% instillation; efficacy', 'efficacy and safety', 'conjunctival hyperemia', 'relief of ocular itching']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009766', 'cui_str': 'Allergic conjunctivitis'}, {'cui': 'C0440380', 'cui_str': 'Japanese cedar pollen'}, {'cui': 'C0567350', 'cui_str': 'Cedar pollen'}]","[{'cui': 'C0527189', 'cui_str': 'olopatadine'}, {'cui': 'C2348241', 'cui_str': 'alcaftadine'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C2348241', 'cui_str': 'alcaftadine'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022281', 'cui_str': 'Itching of eye'}]",263.0,0.136799,Alcaftadine 0.25% at 16 hours was non-inferior to Olopatadine at 4 hours.,"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Fujishima', 'Affiliation': 'Department of Ophthalmology, Tsurumi University School of Dental Medicine , Kanagawa, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Hasunuma', 'Affiliation': 'Department of Research, Kitasato University Kitasato Institute Hospital , Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kawakita', 'Affiliation': 'Department of Ophthalmology, Kitasato University Kitasato Institute Hospital , Tokyo, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Sekiya', 'Affiliation': 'Research & Development Division, Senju Pharmaceutical Co., Ltd , Osaka, Japan.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gomes', 'Affiliation': 'Allergy Department, Ora, Inc , Andover, Massachusetts, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hollander', 'Affiliation': 'Allergy Department, Ora, Inc , Andover, Massachusetts, USA.'}]",Ocular immunology and inflammation,['10.1080/09273948.2020.1760309']
2726,32501814,Ethanol-Based Disinfectants Containing Urea May Reduce Soap Sensitivity.,"BACKGROUND
The use of disinfectants is crucial to preventing the spread of nosocomial infections in health care workers. As many as 25 applications of hand disinfectants is a realistic default value during a working day. However, alcohol-based hand disinfectants may weaken skin barrier function and induce dryness and eczema, which decrease their acceptance.
OBJECTIVE
To evaluate the effect of ethanol-containing disinfectants with 5% urea on skin barrier function and on sensitivity to an irritant soap (sodium lauryl sulfate [SLS]).
METHODS
Twenty healthy volunteers treated one of their forearms twice daily for 17 days with an ethanol-containing gel with 5% urea. Two types of gels with urea were tested. Treatment was randomized to left or right forearm, and the contralateral forearm served as untreated control. Transepidermal water loss, skin capacitance (dryness), and sensitivity to SLS were evaluated.
RESULTS
Twice-daily application of the urea-containing ethanol gels lowered transepidermal water loss, prevented dryness, and reduced sensitivity to SLS compared with the untreated control skin.
CONCLUSIONS
Improved barrier function using this ethanol gel with urea may have relevance in daily disinfectant procedures.",2020,"RESULTS
Twice-daily application of the urea-containing ethanol gels lowered transepidermal water loss, prevented dryness, and reduced sensitivity to SLS compared with the untreated control skin.
","['Twenty healthy volunteers treated one of their forearms twice daily for 17 days with an', 'health care workers']","['Ethanol-Based Disinfectants Containing Urea', 'ethanol-containing disinfectants', 'contralateral forearm served as untreated control', 'irritant soap (sodium lauryl sulfate [SLS', 'ethanol-containing gel with 5% urea']","['skin barrier function and induce dryness and eczema', 'Transepidermal water loss, skin capacitance (dryness), and sensitivity to SLS', 'skin barrier function', 'Soap Sensitivity', 'transepidermal water loss, prevented dryness, and reduced sensitivity to SLS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022108', 'cui_str': 'Irritant'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",20.0,0.0301597,"RESULTS
Twice-daily application of the urea-containing ethanol gels lowered transepidermal water loss, prevented dryness, and reduced sensitivity to SLS compared with the untreated control skin.
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lodén', 'Affiliation': 'From the Eviderm Institute AB, Solna, Sweden.'}]","Dermatitis : contact, atopic, occupational, drug",['10.1097/DER.0000000000000612']
2727,32501815,Who is reached by HIV self-testing? Individual factors associated with self-testing within a community-based programme in rural Malawi.,"INTRODUCTION
HIV self-testing (HIVST) is an alternative strategy for reaching population sub-groups underserved by available HIV testing services. We assessed individual factors associated with ever HIVST within a community-based programme.
SETTING
Malawi.
METHODS
We conducted secondary analysis of an endline survey administered under a cluster-randomised trial of community-based distribution of HIVST kits. We estimated prevalence differences and prevalence ratios (PR) stratified by sex for the outcome: self-reported ever HIVST.
RESULTS
Prevalence of ever HIVST was 45.0% (475/1,055) among men and 40.1% (584/1,456) among women. Age was associated with ever HIVST in both men and women, with evidence of a strong declining trend across categories of age. Compared with adults aged 25-39 years, HIVST was lowest among adults aged 40 years and older for both men (34.4%, 121/352; PR 0.74, 95% CI 0.62-0.88) and women (30.0%, 136/454; PR 0.71, 95% CI 0.6-0.84). Women who were married, had children, had higher levels of education or were wealthier were more likely to self-test. Men who had condomless sex in the last three months (47.9%, 279/582) reported higher HIVST prevalence compared with men who did not have recent condomless sex (43.1%, 94/218; aPR 1.37, 95% CI: 1.06-1.76). Among men and women, the level of previous exposure to HIV testing and household HIVST uptake were associated with HIVST.
CONCLUSIONS
Community-based HIVST reached men, younger age groups, and some at-risk individuals. HIVST was lowest among older adults and individuals with less previous exposure to HIV testing, suggesting the presence of ongoing barriers to HIV testing.",2020,"Compared with adults aged 25-39 years, HIVST was lowest among adults aged 40 years and older for both men (34.4%, 121/352; PR 0.74, 95% CI 0.62-0.88) and women (30.0%, 136/454; PR 0.71, 95% CI 0.6-0.84).","['Women who were married, had children']","['HIV self-testing (HIVST', 'HIVST kits', 'HIVST']","['HIVST prevalence', 'Prevalence of ever HIVST', 'level of previous exposure to HIV testing and household HIVST uptake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0020052', 'cui_str': 'Households'}]",,0.111305,"Compared with adults aged 25-39 years, HIVST was lowest among adults aged 40 years and older for both men (34.4%, 121/352; PR 0.74, 95% CI 0.62-0.88) and women (30.0%, 136/454; PR 0.71, 95% CI 0.6-0.84).","[{'ForeName': 'Pitchaya P', 'Initials': 'PP', 'LastName': 'Indravudh', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Hensen', 'Affiliation': 'Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Nzawa', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Chilongosi', 'Affiliation': 'Population Services International, Lilongwe, Malawi.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Nyirenda', 'Affiliation': 'Department of HIV and AIDS, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Cheryl C', 'Initials': 'CC', 'LastName': 'Johnson', 'Affiliation': 'Department of HIV/AIDS, World Health Organisation, Geneva, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hatzold', 'Affiliation': 'Population Services International, Washington D.C., United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fielding', 'Affiliation': 'Department of Infectious Disease Epidemiology and MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Neuman', 'Affiliation': 'Department of Infectious Disease Epidemiology and MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002412']
2728,32501868,Novel Orally Administered Recombinant Anti-TNF Alpha Fusion Protein for the Treatment of Ulcerative Colitis: Results From a Phase 2a Clinical Trial.,"BACKGROUND AND OBJECTIVE
OPRX-106 is an orally administered BY2 plant cell-expressing recombinant TNF fusion protein (TNFR). Oral administration of OPRX-106 was shown to be safe and effective in inducing favorable anti-inflammatory immune modulation in humans. The current study was aimed at determining the safety and efficacy of OPRX-106 in patients with ulcerative colitis (UC).
METHODS
Twenty-five patients with active mild-to-moderate UC were enrolled in an open-label trial. Patients were randomized to receive 2 or 8 mg of OPRX-106 administered orally once daily, for 8 weeks. Patients were monitored for safety and efficacy including clinical response or clinical remission, based on the Mayo score. The histopathological improvement in Geboes score, calprotectin level and hs-CRP, and exploratory immune parameters by means of fluorescence-activated cell sorting and cytokine levels were monitored.
RESULTS
Oral administration of OPRX-106 was found to be safe and well tolerated without absorption into the circulation. Out of 24 patients, 18 completed the trial. The analysis of the patients completing treatment demonstrated clinical efficacy as measured by clinical response or remission in 67% and 28%, respectively. Reduction in calprotectin levels and improved Geboes score were noted in the majority of the treated patients. The beneficial clinical effect was associated with an increase in a CD4+CD25+FoxP3 subset of suppressor lymphocytes and a reduction in interleukin 6 and interferon gamma serum levels.
CONCLUSIONS
Oral administration of the nonabsorbable OPRX-106 is safe and effective in mild-to-moderate UC, and not associated with immune suppression, while inducing favorable anti-inflammatory immune modulation.",2020,"The beneficial clinical effect was associated with an increase in a CD4+CD25+FoxP3 subset of suppressor lymphocytes and a reduction in interleukin 6 and interferon gamma serum levels.
","['24 patients, 18 completed the trial', 'Ulcerative Colitis', 'patients with ulcerative colitis (UC', 'Twenty-five patients with active mild-to-moderate UC were enrolled in an open-label trial']","['Recombinant Anti-TNF Alpha Fusion Protein', 'OPRX-106', 'nonabsorbable OPRX-106', 'BY2 plant cell-expressing recombinant TNF fusion protein (TNFR']","['clinical response or remission', 'clinical efficacy', 'calprotectin levels and improved Geboes score', 'safety and efficacy', 'safety and efficacy including clinical response or clinical remission', 'histopathological improvement in Geboes score, calprotectin level and hs-CRP, and exploratory immune parameters by means of fluorescence-activated cell sorting and cytokine levels', 'interleukin 6 and interferon gamma serum levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}, {'cui': 'C3178867', 'cui_str': 'Plant Cells'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079366', 'cui_str': 'Fluorescence-Activated Cell Sorting'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",25.0,0.0554782,"The beneficial clinical effect was associated with an increase in a CD4+CD25+FoxP3 subset of suppressor lymphocytes and a reduction in interleukin 6 and interferon gamma serum levels.
","[{'ForeName': 'Einat', 'Initials': 'E', 'LastName': 'Almon', 'Affiliation': 'Protalix, Carmiel.'}, {'ForeName': 'Yoseph', 'Initials': 'Y', 'LastName': 'Shaaltiel', 'Affiliation': 'Protalix, Carmiel.'}, {'ForeName': 'Wisam', 'Initials': 'W', 'LastName': 'Sbeit', 'Affiliation': 'Western Galilee Hospital, Nahariya.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Fich', 'Affiliation': 'Soroka Medical Center, Beer Sheva.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Schwartz', 'Affiliation': 'Soroka Medical Center, Beer Sheva.'}, {'ForeName': 'Mattitiahu', 'Initials': 'M', 'LastName': 'Waterman', 'Affiliation': 'Rambam Medical Center, Haifa.'}, {'ForeName': 'Mali', 'Initials': 'M', 'LastName': 'Szlaifer', 'Affiliation': 'Protalix, Carmiel.'}, {'ForeName': 'Hadar', 'Initials': 'H', 'LastName': 'Reuveni', 'Affiliation': 'Protalix, Carmiel.'}, {'ForeName': 'Bat-Chen', 'Initials': 'BC', 'LastName': 'Amit-Cohen', 'Affiliation': 'Protalix, Carmiel.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Alon', 'Affiliation': 'Protalix, Carmiel.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Chertkoff', 'Affiliation': 'Protalix, Carmiel.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Paz', 'Affiliation': 'Protalix, Carmiel.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Ilan', 'Affiliation': 'Hadassah Medical Center, Jerusalem, Israel.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001314']
2729,32501914,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND
ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population.
METHODS
Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications.
RESULTS
The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group.
CONCLUSIONS
There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients.
LEVEL OF EVIDENCE
Level I.",2020,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480']
2730,32501985,Influences of different dose of tirofiban for acute ST elevation myocardial infarction patients underwent percutaneous coronary intervention.,"Tirofiban is widely used in patients with acute ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). This drug can efficiently improve myocardial perfusion and cardiac function, but its dose still remains controversial. We here investigated the effects of different dose of tirofiban on myocardial reperfusion and heart function in patients with STEMI. A total of 312 STEMI patients who underwent PCI in our hospital from March 2017 to March 2018 were enrolled and randomly divided into control group (75 cases, 0 μg/kg), low-dose group (79 cases, 5 μg/kg), medium-dose group (81 cases, 10 μg/kg) and high-dose group (77 cases, 20 μg/kg). The infarction-targeted artery flow grade evaluated by thrombolysis in myocardial infarction (TIMI), corrected TIMI frame count (CTFC) and sum-ST-segment resolution were recorded. At Day 7 and Day 30 after PCI, the left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter, left ventricular end systolic diameter, major adverse cardiovascular events and the hemorrhage and thrombocytopenia were also evaluated. After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05). Moreover, the LVEF, left ventricular end diastolic diameter and left ventricular end systolic diameter of high-dose group were significantly improved than those of other groups, and the LVEF of medium-dose group was significantly superior to that of low-dose group (P < .05). However, the incidence of major adverse cardiac events in high-dose group was significantly decreased, while the hemorrhage and incidence of thrombocytopenia of high-dose group were significantly higher than those of other 3 groups (P < .05). The tirofiban can effectively alleviate the myocardial ischemia-reperfusion injury and promote the recovery of cardiac function in STEMI patients underwent PCI. Although the high-dose can enhance the clinical effects, it also increased the hemorrhagic risk. Therefore, the rational dosage application of tirofiban become much indispensable in view of patient's conditions and hemorrhagic risk, and a medium dose of 10 μg/kg may be appropriate for patients without high hemorrhagic risk.",2020,"After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05).","['acute ST elevation myocardial infarction patients underwent percutaneous coronary intervention', 'patients without high hemorrhagic risk', 'patients with STEMI', '312 STEMI patients who underwent PCI in our hospital from March 2017 to March 2018', 'patients with acute ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI']","['tirofiban', 'Tirofiban']","['infarction-targeted artery flow grade evaluated by thrombolysis in myocardial infarction (TIMI), corrected TIMI frame count (CTFC) and sum-ST-segment resolution', 'left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter, left ventricular end systolic diameter, major adverse cardiovascular events and the hemorrhage and thrombocytopenia', 'incidence of major adverse cardiac events', 'myocardial perfusion and cardiac function', 'rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution', 'hemorrhage and incidence of thrombocytopenia', 'LVEF, left ventricular end diastolic diameter and left ventricular end systolic diameter', 'myocardial reperfusion and heart function', 'hemorrhagic risk']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}]","[{'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027054', 'cui_str': 'Reperfusion, Myocardial'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",312.0,0.0198557,"After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05).","[{'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department Pharmacy, the Second Clinical Hospital of Shanxi Medical University, Taiyuan, Shanxi.'}, {'ForeName': 'Meiqin', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'AstraZeneca (Wuxi) trading co. LTD, Wuxi, Jiangsu, China.'}]",Medicine,['10.1097/MD.0000000000020402']
2731,32502040,"The research of Tuna Huichun Gong on pulmonary function, exercise tolerance, and quality of life in patients with chronic obstructive pulmonary disease based on the concept of early pulmonary rehabilitation.","INTRODUCTION
Chronic obstructive pulmonary disease (COPD) is a common high-burden and highly disabling lung disease. The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles. Although recommended by the global initiative for chronic obstructive lung disease guidelines, pulmonary rehabilitation (PR) has not been used widely because of its inherent limitations. Tuna-Hui-Chun-Gong (TNHCG) is a popular traditional exercise used to treat COPD in China. We aim to evaluate the safety and efficacy of TNHCG for PR of COPD.
METHODS
The provided protocol is for a single-blind randomized controlled trial in which 120 COPD patients will be randomly and equally divided into the experimental or control group. The control group will be treated with standard COPD drugs while the experimental group will perform TNHCG exercises apart from standard drug treatment. The duration of treatment will be 24 weeks and a follow-up for 48 weeks. The primary outcome will be the 6-Minute Walk Test. The secondary outcomes will include the pulmonary function test, St George's respiratory questionnaire, COPD assessment test, modified medical research council dyspnea scale, Hospital Anxiety and Depression Scale, and exacerbation frequency. A safety assessment will also be performed during the trial.
DISCUSSION
Our study will provide evidence to support TNHCG exercise as an additional measure for PR of COPD.
TRIAL REGISTRATION
ChiCTR1900028332, Registered December 29, 2019.
ETHICS AND DISSEMINATION
Ethics approval has been granted by the Sichuan Traditional Chinese Medicine Regional Ethics Review Committee (No. 2019KL-050).",2020,The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles.,"['Chronic obstructive pulmonary disease (COPD', '120 COPD patients', 'patients with chronic obstructive pulmonary disease based on the concept of early pulmonary rehabilitation', 'patients with COPD', 'Registered December 29, 2019']","['Tuna Huichun Gong', 'Tuna-Hui-Chun-Gong (TNHCG', 'TNHCG', 'TNHCG exercise', 'standard COPD drugs while the experimental group will perform TNHCG exercises']","['pulmonary function, exercise tolerance, and quality of life', '6-Minute Walk Test', 'quality of life and exercise endurance', 'safety and efficacy', ""pulmonary function test, St George's respiratory questionnaire, COPD assessment test, modified medical research council dyspnea scale, Hospital Anxiety and Depression Scale, and exacerbation frequency""]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0041382', 'cui_str': 'Tuna'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",120.0,0.106714,The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Su', 'Affiliation': 'Department of Cardiothoracic Surgery, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qianming', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Respiratory Medicine, AVIC 363 Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Yuewei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiothoracic Surgery, Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020625']
2732,32502043,A retrospective study of probiotics for the treatment of children with antibiotic-associated diarrhea.,"This retrospective study aimed to explore the benefits and safety of probiotics (live combined Bacillus subtilis and Enterococcus faecium granules with multivitamines) for the treatment of children with antibiotic-associated diarrhea (AAD).A total of 72 children with AAD were analyzed in this study. Of these, 36 children received routine treatment plus probiotics, and were assigned to a treatment group. The other 36 children underwent routine treatment alone, and were assigned to a control group. Patients in both groups were treated for a total of 7 days. The efficacy and safety were evaluated by duration of diarrhea (days), number of dressings needed daily, abdominal pain intensity, stool consistency (as assessed by Bristol Stool Scale (BSS)), and any adverse events.After treatment, probiotics showed encouraging benefits in decreasing duration of diarrhea (days) (P < .01), number of dressings needed every day (P < .01), abdominal pain intensity (P < .01), and stool consistency (BSS (3-5), P < .01; BSS (6-7), P < .01). In addition, no adverse events were documented in this study.The findings of this study demonstrated that probiotics may provide promising benefit for children with AAD. Further studies are still needed to warrant theses findings.",2020,"(P < .01), number of dressings needed every day (P < .01), abdominal pain intensity (P < .01), and stool consistency (BSS (3-5), P < .01; BSS (6-7), P < .01).","['36 children received', 'children with antibiotic-associated diarrhea (AAD).A total of 72 children with AAD', 'children with AAD', '36 children underwent', 'children with antibiotic-associated diarrhea']","['probiotics (live combined Bacillus subtilis and Enterococcus faecium granules with multivitamines', 'probiotics', 'routine treatment plus probiotics', 'routine treatment alone']","['abdominal pain intensity', 'stool consistency (BSS', 'number of dressings needed every day', 'efficacy and safety', 'adverse events', 'duration of diarrhea (days), number of dressings needed daily, abdominal pain intensity, stool consistency (as assessed by Bristol Stool Scale (BSS)), and any adverse events', 'duration of diarrhea (days']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0578159', 'cui_str': 'Antibiotic-associated diarrhea'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0085495', 'cui_str': 'Enterococcus faecium'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0005129', 'cui_str': 'Bernard Soulier syndrome'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",72.0,0.0269625,"(P < .01), number of dressings needed every day (P < .01), abdominal pain intensity (P < .01), and stool consistency (BSS (3-5), P < .01; BSS (6-7), P < .01).","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Rui', 'Affiliation': 'Department of Microecology, School of Basic Medical Science, Jiamusi University, Jiamusi, China.'}, {'ForeName': 'Shu-Xia', 'Initials': 'SX', 'LastName': 'Ma', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020631']
2733,32502050,Effect of video-guided educational intervention on school engagement of adolescent students with hearing impairment: Implications for health and physical education.,"BACKGROUND/OBJECTIVE
Hearing impaired students still face stigmatization and marginalization especially in inclusive classrooms in developing regions. This negatively impacts their school engagement. The present study aimed at ascertaining the effect of video-guided educational intervention on school engagement of hearing impaired students.
METHOD
Randomized controlled trial design was adopted for the present study. A total of 46 junior secondary school students with hearing impairment and low school engagement symptoms participated in this study. The students were randomly assigned to groups - intervention group and care-as-usual control group. A video-guided educational intervention package which consists of 13-minutes captioned video clips with school engagement themes served as the treatment intervention. Data were collected at 3 different times (pre-test, post-test and follow up) using School Engagement Scale created by Fredericks, Blumenfeld, Friedel and Paris (2005). Data were analyzed using independent sample t-test, paired sample t-test, Cohen d and Chi-square.
RESULTS
Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = -9.305, P < .001; Emotional: t(24) = -7.772, P < .001; Cognitive: t(24) = -7.330 P < .001) as well as total student engagement (t(24) = 12.022, P < .001, Δ = 5.362). Also, the students who took part in the video-guided educational intervention maintained improved school engagement at follow-up.
CONCLUSION
Video-guided educational intervention is an effective intervention for improving school engagement of hearing impaired adolescent students. Since acquiring relevant education is essential for leading a quality life especially among the special needs population, it was recommended that students with hearing impairment should be helped to acquire life skills through education by fostering their school engagement.",2020,"RESULTS
Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = ","['students with hearing impairment', 'hearing impaired adolescent students', '46 junior secondary school students with hearing impairment and low school engagement symptoms participated in this study', 'school engagement of hearing impaired students', 'adolescent students with hearing impairment']","[' intervention group and care-as-usual control group', 'video-guided educational intervention', 'Video-guided educational intervention']","['total student engagement', 'school engagement level', 'school engagement']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0308663,"RESULTS
Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = ","[{'ForeName': 'Uche D', 'Initials': 'UD', 'LastName': 'Asogwa', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Theresa Onyema', 'Initials': 'TO', 'LastName': 'Ofoegbu', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Chimaobi Samuel', 'Initials': 'CS', 'LastName': 'Ogbonna', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Ngozi O', 'Initials': 'NO', 'LastName': 'Obiyo', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Godfrey C', 'Initials': 'GC', 'LastName': 'Nji', 'Affiliation': 'Department Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State.'}, {'ForeName': 'Oliver Rotachukwu', 'Initials': 'OR', 'LastName': 'Ngwoke', 'Affiliation': 'Department Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State.'}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Christian Iheanacho', 'Initials': 'CI', 'LastName': 'Agboti', 'Affiliation': 'Department of Sociology/Criminology and Security Studies, Alex-Ekwueme Federal University Ndufu Alike Ikwo, Ebonyi State, Nigeria.'}, {'ForeName': 'Chinedozie', 'Initials': 'C', 'LastName': 'Uwakwe', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Benedict C', 'Initials': 'BC', 'LastName': 'Eze', 'Affiliation': 'Department of Arts Education.'}]",Medicine,['10.1097/MD.0000000000020643']
2734,32502072,Somatic Symptom Perception from a Predictive Coding Perspective - an Empirical Test Using the Thermal Grill Illusion.,"OBJECTIVE
In a predictive coding perspective, symptom perceptions result from an integration of pre-existing information in memory with sensory input. Physical symptoms can therefore reflect the relative predominance of either sensory input or pre-existing information. In this study, we used the thermal grill illusion (TGI), which applies interlaced warm and cool temperatures to the skin to create a paradoxical heat-pain experience. Assuming that the TGI compared to single temperature stimulation relies more importantly on an active integration process of the brain to create this paradoxical sensation, we tested the hypothesis whether a manipulation of the expectations during TGI would have more impact than during single temperature stimulation.
METHODS
Sixty-four participants received different temperature combinations (16/16 °C, 40/40 °C, 16/40 °C) with neutral, positive (""placebo""), and negative (""nocebo"") instructions. Subjective stimulus intensity was rated and neuroticism and absorption (openness to absorbing and self-altering experiences) served as potential moderating factors.
RESULTS
The TGI condition was rated highest. Overall, negative instructions increased (p < .001, d = 0.58), whereas positive instructions did not significantly change the TGI intensity perception (vs. neutral; p = .144, d = 0.19). In the TGI condition, increased modulation of pain was observed with higher neuroticism (β = .33, p = .005) and absorption (β = 0.30, p = .010).
CONCLUSIONS
Whereas negative instructions induced a nocebo effect, no placebo effect emerged after positive instructions. The findings are in line with the predictive coding model of symptom perception for participants with higher levels of neuroticism and absorption.",2020,"Overall, negative instructions increased (p < .001, d = 0.58), whereas positive instructions did not significantly change the TGI intensity perception (vs. neutral; p = .144, d = 0.19).","['Sixty-four participants received different temperature combinations (16/16 °C, 40/40 °C, 16/40 °C) with']","['neutral, positive (""placebo""), and negative (""nocebo"") instructions', 'thermal grill illusion (TGI']","['modulation of pain', 'TGI intensity perception', 'Overall, negative instructions', 'Subjective stimulus intensity was rated and neuroticism and absorption (openness to absorbing and self-altering experiences']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0450328', 'cui_str': '16/16'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}]","[{'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1842981', 'cui_str': 'Neuroticism Traits'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0547049', 'cui_str': 'Openness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",64.0,0.102744,"Overall, negative instructions increased (p < .001, d = 0.58), whereas positive instructions did not significantly change the TGI intensity perception (vs. neutral; p = .144, d = 0.19).","[{'ForeName': 'Anne-Kathrin', 'Initials': 'AK', 'LastName': 'Bräscher', 'Affiliation': 'Department for Clinical Psychology, Psychotherapy, and Experimental Psychopathology, Johannes Gutenberg University Mainz, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sütterlin', 'Affiliation': 'Faculty for Health and Welfare Sciences, Østfold University College, Norway.'}, {'ForeName': 'Raymonde', 'Initials': 'R', 'LastName': 'Scheuren', 'Affiliation': 'Psychologist Center, 31, bd. Prince Henri, L-1724 Luxembourg.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Van den Bergh', 'Affiliation': 'KU Leuven - University of Leuven, Health Psychology, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': 'Department for Clinical Psychology, Psychotherapy, and Experimental Psychopathology, Johannes Gutenberg University Mainz, Germany.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000824']
2735,32502088,"The Effect of Numbered Jerseys on Directed Commands, Teamwork, and Clinical Performance During Simulated Emergencies.","Communication and teamwork are essential during inpatient emergencies such as cardiac arrest and rapid response (RR) codes. We investigated whether wearing numbered jerseys affect directed commands, teamwork, and performance during simulated codes. Eight teams of 6 residents participated in 64 simulations. Four teams were randomized to the experimental group wearing numbered jerseys, and four to the control group wearing work attire. The experimental group used more directed commands (49% vs. 31%, p < .001) and had higher teamwork score (25 vs. 18, p < .001) compared with control group. There was no difference in time to initiation of chest compression, bag-valve-mask ventilation, and correct medications. Time to defibrillation was longer in the experimental group (190 vs. 140 seconds, p = .035). Using numbered jerseys during simulations was associated with increased use of directed commands and better teamwork. Time to performance of clinical actions was similar except for longer time to defibrillation in the jersey group.",2020,"Time to defibrillation was longer in the experimental group (190 vs. 140 seconds, p = .035).",['Eight teams of 6 residents participated in 64 simulations'],['control group wearing work attire'],"['Time to defibrillation', 'time to initiation of chest compression, bag-valve-mask ventilation, and correct medications', 'higher teamwork score']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1960845', 'cui_str': 'Bag valve mask ventilation'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",4.0,0.072803,"Time to defibrillation was longer in the experimental group (190 vs. 140 seconds, p = .035).","[{'ForeName': 'Yekaterina', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Akiva A', 'Initials': 'AA', 'LastName': 'Dym', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Fein', 'Affiliation': ''}, {'ForeName': 'Maneesha', 'Initials': 'M', 'LastName': 'Bangar', 'Affiliation': ''}, {'ForeName': 'Hannah R B', 'Initials': 'HRB', 'LastName': 'Ferenchick', 'Affiliation': ''}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Keene', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Orsi', 'Affiliation': ''}, {'ForeName': 'Moses A', 'Initials': 'MA', 'LastName': 'Washington', 'Affiliation': ''}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Eisen', 'Affiliation': ''}]",Journal for healthcare quality : official publication of the National Association for Healthcare Quality,['10.1097/JHQ.0000000000000264']
2736,32502105,Evaluation of the Nasopharyngeal Cannula Use After Orthognathic Surgery: Permeability of the Nasal Airways and Discomfort of the Patient With Cleft Lip and Palate.,"It is believed that the use of the nasopharyngeal cannula can maintain the patent upper airway in the immediate post-operative period of orthognathic surgery. The present study is a randomized clinical trial with the objective of evaluating the difference in the use of the nasopharyngeal cannula in the post-operative period of orthognathic surgery with respect to permeability and discomfort. The sample was composed of 26 individuals with repaired cleft lip and palate randomly distributed in 2 groups with and without nasopharyngeal cannula. The evaluation was composed by Visual Analogue Scale (VAS), test with Altman mirror in 4 pre-operative periods, 6, 24, 30 hours after the operation. Rhinomanometry was also performed, a flow- pressure technique in 2 distinct moments, 6 and 24 hours after surgery. As a result, greater discomfort, greater obstruction as well as a reduction in the area of bilateral minimum nasal cross-section (ASTM) and increased resistance in the group with nasopharyngeal cannula are observed. In the intra-group comparison with the lowest ASTM values, the test group showed a significant difference between the first and the second moments (P = 0.001). It can be concluded that the nasopharyngeal cannula contributes to increase discomfort, worsens airway permeability by decreasing ASTM and increasing nasal resistance. Regarding the length of stay of the nasopharyngeal cannula, it can be said that from 6 hours onwards it does not contribute to the reduction of discomfort, airway permeability and assist in hemostasis.",2020,"In the intra-group comparison with the lowest ASTM values, the test group showed a significant difference between the first and the second moments (P = 0.001).",['26 individuals with repaired cleft lip and palate randomly distributed in 2 groups with and without nasopharyngeal cannula'],['Nasopharyngeal Cannula Use'],"['Visual Analogue Scale (VAS', 'nasal resistance', 'discomfort, airway permeability and assist in hemostasis']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0192070', 'cui_str': 'Repair of cleft lip'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}]","[{'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",,0.02369,"In the intra-group comparison with the lowest ASTM values, the test group showed a significant difference between the first and the second moments (P = 0.001).","[{'ForeName': 'Maycon Rafael Zanoni', 'Initials': 'MRZ', 'LastName': 'Jordão', 'Affiliation': 'Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo (HRAC-USP).'}, {'ForeName': 'Ana Carolina Boneti', 'Initials': 'ACB', 'LastName': 'Valente', 'Affiliation': 'Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo (HRAC-USP).'}, {'ForeName': 'Marina de Almeida Barbosa', 'Initials': 'MAB', 'LastName': 'Mello', 'Affiliation': 'Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo (HRAC-USP).'}, {'ForeName': 'Juliana Specian Zabotini', 'Initials': 'JSZ', 'LastName': 'da Silveira', 'Affiliation': 'Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo (HRAC-USP).'}, {'ForeName': 'Hélcio José', 'Initials': 'HJ', 'LastName': 'de Moura Junior', 'Affiliation': 'Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo (HRAC-USP).'}, {'ForeName': 'Renata Paciello', 'Initials': 'RP', 'LastName': 'Yamashita', 'Affiliation': 'Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo (HRAC-USP).'}, {'ForeName': 'Renato Yassutaka Faria', 'Initials': 'RYF', 'LastName': 'Yaedú', 'Affiliation': 'Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo (HRAC-USP).'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006605']
2737,32502164,Effect of practice exergames on the mood states and self-esteem of elementary school boys and girls during physical education classes: A cluster-randomized controlled natural experiment.,"Reduced physical exercise can impact children's mental health. Use of active electronic games can help promote psychological health. Physical education (PE class) uses different resources, methods, and contents to promote student health. We investigated the effect of exergames on the mood and self-esteem of children and compare it that of with traditional PE classes. From a sample of 213 children (7-11 years old), 140 from 10 classes of the fourth and fifth grades of elementary school (59 boys, 81 girls; mean age 9.41±0.48 years), allocated to an experimental group (EG; n = 68; five clusters) and a PE group (PE; n = 72; five clusters), participated in this experimental controlled study. The EG practiced exergames during three 40-minute classes, and the PE group held three routine curricular PE classes. Brunel's Mood Scale and Rosenberg's Self-Esteem Scale were applied. Repeated measures ANOVA identified differences between sexes and groups. The main results of the EG demonstrated reduced tension in girls (p <0.05; ES: 0.62; 95% CI: 0.17-1.05). Regarding sex comparisons, anger was lower in girls (F: 4.57; p <0.05; ES: 0.61; 95% CI: 0.11-1.11) in the EG. Vigor was higher in girls in the EG than in those in the PE group (F: 5.46; p <0.05; ES: 0.56; 95% CI: 0.12-1.01). The main results of the PE group indicated increased self-esteem in boys (p <0.05; ES: 0.58; 95% CI: 0.08-1.07) and reduction of girls' mental confusion (p <0.05; ES 0.58; 95% CI 0.15-1.06). Thus, exergames impact boys' and girls' self-esteem and mood, as well as traditional physical education classes. Further study on exergames in schools is essential, with long-term effects on physical and mental health. Exergames bring interesting, varied content, technology, and innovation that can increase the attractiveness of physical education.",2020,The main results of the EG demonstrated reduced tension in girls (p <0.05; ES: 0.62; 95% CI: 0.17-1.05).,"['213 children (7-11 years old), 140 from 10 classes of the fourth and fifth grades of elementary school (59 boys, 81 girls; mean age 9.41±0.48 years', 'elementary school boys and girls during physical education classes']","['physical exercise', 'Physical education (PE class', 'practice exergames', 'active electronic games']","[""Brunel's Mood Scale and Rosenberg's Self-Esteem Scale"", 'Vigor', ""reduction of girls' mental confusion"", 'mood states and self-esteem', 'self-esteem']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",213.0,0.0680954,The main results of the EG demonstrated reduced tension in girls (p <0.05; ES: 0.62; 95% CI: 0.17-1.05).,"[{'ForeName': 'Alexandro', 'Initials': 'A', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Whyllerton Mayron da', 'Initials': 'WMD', 'LastName': 'Cruz', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Clara Knierim', 'Initials': 'CK', 'LastName': 'Correia', 'Affiliation': 'Laboratory of Aquatic Biomechanics, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Ana Luiza Goya', 'Initials': 'ALG', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Guilherme Guimarães', 'Initials': 'GG', 'LastName': 'Bevilacqua', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}]",PloS one,['10.1371/journal.pone.0232392']
2738,32502179,"Efficacy of topical bevacizumab 0.05% eye drops in dry eye disease: A double-masked, randomized trial.","The objective of this double-masked, placebo-controlled, randomized trial was to assess the efficacy and safety of bevacizumab 0.05% eye drops in dry eye patients. This study included Dry Eye Workshop Study (DEWS) Grade 3-4 dry eye participants (n = 31) whose tear break-up time (TBUT) was ≤5 seconds(s). Participants were randomized to undergo treatment with either bevacizumab 0.05% eye drops (n = 19) or placebo (n = 12). The primary outcome was TBUT, and the proportion of responders (increase of ≥3s in TBUT at week 12), ocular surface disease index (OSDI) score, Schirmer test, and Oxford scheme grade were secondary outcomes. All outcomes were measured at 1-, 4- and 12 weeks. TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001). Moreover, the improvement of TBUT in bevacizumab group versus placebo group at 4- and 12 weeks differed significantly from that difference at baseline (P = 0.002 and P = 0.003, respectively). The proportion of participants achieving increase of 3 seconds or more of TBUT at week 12 in the bevacizumab group was significantly greater than that in the placebo group (P = 0.02). Oxford scheme grade at 1-, 4- and 12 weeks differed significantly from the values at baseline in bevacizumab group (P = 0.001, P = 0.01, and P = 0.03, respectively). OSDI scores at 1-, 4- and 12-week follow-ups were significantly lower than that at baseline in bevacizumab group (P<0.001 at each follow-up). Schirmer test were not significantly different within or between groups (the lowest P = 0.92). No adverse events occurred in this study. Patients treated with bevacizumab 0.05% eye drops showed significant improvement in tear film stability, corneal staining and symptoms.",2020,TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001).,"['dry eye patients', 'dry eye disease']","['bevacizumab 0.05% eye drops', 'topical bevacizumab', 'bevacizumab', 'placebo']","['tear film stability, corneal staining and symptoms', 'OSDI scores', 'proportion of participants achieving increase of 3 seconds or more of TBUT', 'efficacy and safety', 'TBUT, and the proportion of responders (increase of ≥3s in TBUT at week 12), ocular surface disease index (OSDI) score, Schirmer test, and Oxford scheme grade', 'adverse events']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",31.0,0.52162,TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001).,"[{'ForeName': 'Ngamjit', 'Initials': 'N', 'LastName': 'Kasetsuwan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kanawat', 'Initials': 'K', 'LastName': 'Chantaralawan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Usanee', 'Initials': 'U', 'LastName': 'Reinprayoon', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lita', 'Initials': 'L', 'LastName': 'Uthaithammarat', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0234186']
2739,32502206,Digital versus analogue record systems for mass casualty incidents at sea-Results from an exploratory study.,"OBJECTIVE
Mis-triage may have serious consequences for patients in mass casualty incidents (MCI) at sea. The purpose of this study was to assess outcome, reliability and validity of an analogue and a digital recording system for triage of a MCI at sea.
METHODS
The study based on a triage exercise conducted with a cross-over-design. Forty-eight volunteers were presented a fictional MCI with 50 cases. The volunteers were randomly assigned to start with the analogue (Group A, starting with the analogue followed by the digital system) or digital system (Group B, starting with the digital followed by the analogue system). Triage score distribution and agreement between the triage methods and a predefined standard were reported. Reliability was analysed using Cronbach's Alpha and Cohen's Kappa. Validity was measured through sensitivity, specificity and predictive value. Treatment, period and carry-over-effects were analysed using a linear mixed-effects model.
RESULTS
The number of patients triaged (total: n = 3545) with the analogue system (n = 1914; 79.75%) was significantly higher (p = 0.001) than with the digital system (n = 1631; 67.96%). A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282). Ratio of under-triage was significantly smaller with the digital system (p = 0.001). Validity measured with Cronbach's Alpha and Cohen's Kappa was higher with the digital system. So was sensitivity (category; green: 80.67%, yellow: 73.24%, red: 83.54%; analogue: green: 93.28%, yellow: 82.36%, red: 94.04%) and specificity of the digital system (green: 78.07%, yellow: 63.75%, red: 66.25%; analogue: green: 85.50%, yellow: 79.88%, red: 91.50%). Comparing the predictive values and accuracy, the digital system showed higher scores than the analogue system. No significant patterns of carry-over-effects were observed.
CONCLUSIONS
Significant differences were found for the number of triages comparing the analogue and digital recording system. The digital system has a slightly higher reliability and validity than the analogue triage system.",2020,A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282).,"['patients in mass casualty incidents (MCI) at sea', 'Forty-eight volunteers were presented a fictional MCI with 50 cases']","['analogue (Group A, starting with the analogue followed by the digital system) or digital system', 'analogue']","['Ratio of under-triage', 'specificity of the digital system ', 'sensitivity, specificity and predictive value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1955957', 'cui_str': 'Mass Casualty Incidents'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",3545.0,0.0347985,A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282).,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Henning', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Mustafa Sinan', 'Initials': 'MS', 'LastName': 'Bakir', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Lyubomir', 'Initials': 'L', 'LastName': 'Haralambiev', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schulz-Drost', 'Affiliation': 'Department of Trauma Surgery, Helios Kliniken Schwerin, Schwerin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hinz', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohlmann', 'Affiliation': 'Institute for Community Medicine, Section Methods in Community Medicine, University Medicine Greifswald, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Ekkernkamp', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Gümbel', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}]",PloS one,['10.1371/journal.pone.0234156']
2740,32502306,Motivational processes during physical endurance tasks.,"PURPOSE
Motivational processes are insufficiently recognized in models of human endurance. Hence, two studies examined a motivational model proposing that the quality of pre-task autonomous motivation influences performance at high intensity via the in-task temptation to reduce effort and value of goal pursuit.
METHODS
The studies involved 40 participants each (Study 1: 33% female, M age = 21.55, SD = 1.97; Study 2: 45% female, M age = 22.65, SD = 2.61) completing measures of autonomous motivation prior to a ten-minute cycling task. Measures of the temptation to reduce effort and value of goal pursuit were taken every minute during the trial (Study 1) or near the midpoint of the trial (Study 2). Data were analyzed using multilevel growth and parallel mediation models.
RESULTS
In both studies, autonomous motivation was associated with lower temptation to reduce effort and higher value of goal pursuit, which were subsequently characteristic of better performance. Study 1 revealed nuances within these relationships depending on whether task initiation or change over time were considered. In Study 2, indirect effects of autonomous motivation on performance via temptation to reduce effort (b = .20, 95% CIs .03 - .50) and goal value (b = .26, 95% CIs .01 - .44) were evidenced.
CONCLUSION
Two studies supported a theoretically viable model explaining the dynamics between pre-task and in-task motivation underpinning performance at high intensities.",2020,"In both studies, autonomous motivation was associated with lower temptation to reduce effort and higher value of goal pursuit, which were subsequently characteristic of better performance.","['40 participants each (Study 1: 33% female, M age = 21.55, SD = 1.97; Study 2: 45% female, M age = 22.65, SD = 2.61) completing measures of autonomous motivation prior to a ten-minute cycling task']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439232', 'cui_str': 'min'}]",[],[],40.0,0.0755075,"In both studies, autonomous motivation was associated with lower temptation to reduce effort and higher value of goal pursuit, which were subsequently characteristic of better performance.","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Taylor', 'Affiliation': 'School of Sport, Exercise & Health Sciences, Loughborough University, Leicestershire, United Kingdom, LE11 3TU.'}, {'ForeName': 'Kieren', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'One-Eighty Psychology Behaviour Support, Oxford, United Kingdom.'}, {'ForeName': 'Raymon', 'Initials': 'R', 'LastName': 'Hunte', 'Affiliation': 'Nottingham Trent University, Nottingham, United Kingdom.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13739']
2741,32502311,Isolating adverse effects of glucocorticoids on the embryonic cardiovascular system.,"Antenatal glucocorticoid therapy reduces mortality in the preterm infant, but evidence suggests off-target adverse effects on the developing cardiovascular system. Whether deleterious effects are direct on the offspring or secondary to alterations in uteroplacental physiology is unclear. Here, we isolated direct effects of glucocorticoids using the chicken embryo, a model system in which the effects on the developing heart and circulation of therapy can be investigated, independent of effects on the mother and/or the placenta. Fertilized chicken eggs were incubated and divided randomly into control (C) or dexamethasone (Dex) treatment at day 14 out of the 21-day incubation period. Combining functional experiments at the isolated organ, cellular and molecular levels, embryos were then studied close to term. Chicken embryos exposed to dexamethasone were growth restricted and showed systolic and diastolic dysfunction, with an increase in cardiomyocyte volume but decreased cardiomyocyte nuclear density in the left ventricle. Underlying mechanisms included a premature switch from tissue accretion to differentiation, increased oxidative stress, and activated signaling of cellular senescence. These findings, therefore, demonstrate that dexamethasone treatment can have direct detrimental off-target effects on the cardiovascular system in the developing embryo, which are independent of effects on the mother and/or placenta.",2020,"Antenatal glucocorticoid therapy reduces mortality in the preterm infant, but evidence suggests off-target adverse effects on the developing cardiovascular system.",['Fertilized chicken eggs'],"['dexamethasone', 'Antenatal glucocorticoid therapy', 'dexamethasone (Dex', 'glucocorticoids']","['mortality', 'systolic and diastolic dysfunction']","[{'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}]",,0.0233044,"Antenatal glucocorticoid therapy reduces mortality in the preterm infant, but evidence suggests off-target adverse effects on the developing cardiovascular system.","[{'ForeName': 'Noor E W D', 'Initials': 'NEWD', 'LastName': 'Teulings', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Tessa A C', 'Initials': 'TAC', 'LastName': 'Garrud', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Youguo', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Skeffington', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beck', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Itani', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Fiona G', 'Initials': 'FG', 'LastName': 'Conlon', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Kimberley J', 'Initials': 'KJ', 'LastName': 'Botting', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Nicholas', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ashmore', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Blackmore', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Tong', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Camm', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jan B', 'Initials': 'JB', 'LastName': 'Derks', 'Affiliation': 'Department of Perinatal Medicine, University Medical Centre, Utrecht, Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Logan', 'Affiliation': 'Medical Research Council Mitochondrial Biology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Murphy', 'Affiliation': 'Medical Research Council Mitochondrial Biology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ozanne', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Dino A', 'Initials': 'DA', 'LastName': 'Giussani', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.202000697R']
2742,32502358,Cognitive behavioral therapy as an adjuvant therapy in Acne excoriée: a randomized controlled clinical trial.,"Background : Acne excoriée (AE) is a difficult challenge in dermatology practice. AE is mostly associated with some psychiatric disorders particularly mood disorders. Thus, patients generally continue to manipulate their lesions. It was aimed to compare the effectiveness of cognitive behavioral therapy (CBT) as an adjuvant treatment for AE in a randomized controlled clinical trial. Methods : Thirty-two adults with AE were randomly assigned to CBT or control group. Both the groups received similar standard medication. Furthermore, eight sessions of CBT were held during 2 months in CBT group. Self-reported Skin Picking Scale (SPS), clinical severity rating, beck anxiety and depression inventories were determined at the baseline and after 2-month follow-up. Results : Participants in CBT group showed significantly more improvement on clinical severity score ( p = 0.01) as well as SPS score ( p = 0.02) after 2-month follow-up, in comparison to the control group. Depression and anxiety scores were significantly diminished after two months among CBT group in comparison to controls (p value 0.01 for both anxiety and depression). Conclusion : CBT constitutes a utile treatment option for AE and should be considered as an adjuvant therapy in clinical setting.",2020,Depression and anxiety scores were significantly diminished after two months among CBT group in comparison to controls (p value 0.01 for both anxiety and depression). ,"['Methods : Thirty-two adults with AE', 'Acne excoriée']","[' ', 'Acne excoriée (AE', 'CBT', 'Cognitive behavioral therapy', 'cognitive behavioral therapy (CBT']","['Self-reported Skin Picking Scale (SPS), clinical severity rating, beck anxiety and depression inventories', 'SPS score', 'clinical severity score', 'Depression and anxiety scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1696701', 'cui_str': 'Dermatillomania'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0085292', 'cui_str': 'Stiff-man syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",32.0,0.0318528,Depression and anxiety scores were significantly diminished after two months among CBT group in comparison to controls (p value 0.01 for both anxiety and depression). ,"[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mashayekhi Goyonlo', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saeidi Sardabi', 'Affiliation': 'Department of Industrial and Organizational Psychology, Faculty of Educational Sciences and Psychology, Shahid Chamran university of Ahvaz, Ahvaz, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Moradi Tavalaei', 'Affiliation': 'Department of psychology, Faculty of educational sciences and psychology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khoshnevisan', 'Affiliation': 'Khorasan Higher Education Institution, Mashhad, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Razmara', 'Affiliation': 'Mashhad University of Medical Sciences, Mashhad, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1776207']
2743,32502443,"Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study.","BACKGROUND
Dual blockade of PD-L1 and VEGF has enhanced anticancer immunity through multiple mechanisms and augmented antitumour activity in multiple malignancies. We aimed to assess the efficacy and safety of atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF) in patients with unresectable hepatocellular carcinoma.
METHODS
GO30140 is an open-label, multicentre, multiarm, phase 1b study that enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide. The study included five cohorts, and the two hepatocellular carcinoma cohorts, groups A and F, are described here. Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1. In group A, all patients received atezolizumab (1200 mg) and bevacizumab (15 mg/kg) intravenously every 3 weeks. In group F, patients were randomly assigned (1:1) to receive intravenous atezolizumab (1200 mg) plus intravenous bevacizumab (15 mg/kg) every 3 weeks or atezolizumab alone by interactive voice-web response system using permuted block randomisation (block size of two) and stratification factors of geographical region; macrovascular invasion, extrahepatic spread, or both; and baseline α-fetoprotein concentration. Primary endpoints were confirmed objective response rate in all patients who received the combination treatment for group A and progression-free survival in the intention-to-treat population in group F, both assessed by an independent review facility according to Response Evaluation Criteria in Solid Tumors version 1.1. In both groups, safety was assessed in all patients who received at least one dose of any study treatment. This study is registered with ClinicalTrials.gov, NCT02715531, and is closed to enrolment.
FINDINGS
In group A, 104 patients were enrolled between July 20, 2016, and July 31, 2018, and received atezolizumab plus bevacizumab. With a median follow-up of 12·4 months (IQR 8·0-16·2), 37 (36%; 95% CI 26-46) of 104 patients had a confirmed objective response. The most common grade 3-4 treatment-related adverse events were hypertension (13 [13%]) and proteinuria (seven [7%]). Treatment-related serious adverse events occurred in 25 (24%) patients and treatment-related deaths in three (3%) patients (abnormal hepatic function, hepatic cirrhosis, and pneumonitis). In group F, 119 patients were enrolled and randomly assigned (60 to atezolizumab plus bevacizumab; 59 to atezolizumab monotherapy) between May 18, 2018, and March 7, 2019. With a median follow-up of 6·6 months (IQR 5·5-8·5) for the atezolizumab plus bevacizumab group and 6·7 months (4·2-8·2) for the atezolizumab monotherapy group, median progression-free survival was 5·6 months (95% CI 3·6-7·4) versus 3·4 months (1·9-5·2; hazard ratio 0·55; 80% CI 0·40-0·74; p=0·011). The most common grade 3-4 treatment-related adverse events in group F were hypertension (in three [5%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group) and proteinuria (in two [3%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group). Treatment-related serious adverse events occurred in seven (12%) patients in the atezolizumab plus bevacizumab group and two (3%) patients in the atezolizumab monotherapy group. There were no treatment-related deaths.
INTERPRETATION
Our study shows longer progression-free survival with a combination of atezolizumab plus bevacizumab than with atezolizumab alone in patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy. Therefore, atezolizumab plus bevacizumab might become a promising treatment option for these patients. This combination is being compared with standard-of-care sorafenib in a phase 3 trial.
FUNDING
F Hoffmann-La Roche/Genentech.",2020,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"['119 patients', 'patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy', 'unresectable hepatocellular carcinoma (GO30140', 'Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1', 'enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide', '104 patients were enrolled between July 20, 2016, and July 31, 2018, and received', 'patients with unresectable hepatocellular carcinoma']","['atezolizumab alone', 'intravenous atezolizumab (1200 mg) plus intravenous bevacizumab', 'atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF', 'atezolizumab', 'atezolizumab alone by interactive voice-web response system', 'Atezolizumab with or without bevacizumab', 'standard-of-care sorafenib', 'atezolizumab monotherapy', 'bevacizumab', 'atezolizumab plus bevacizumab']","['median progression-free survival', 'progression-free survival', 'efficacy and safety', 'serious adverse events', 'proteinuria', 'objective response rate', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",104.0,0.146586,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Numata', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Stein', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hack', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spahn', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abdullah', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Aiwu Ruth', 'Initials': 'AR', 'LastName': 'He', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. Electronic address: kyunghunlee@snu.ac.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30156-X']
2744,32502445,"Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial.","BACKGROUND
In the phase 3 LACC trial and a subsequent population-level review, minimally invasive radical hysterectomy was shown to be associated with worse disease-free survival and higher recurrence rates than was open radical hysterectomy in patients with early stage cervical cancer. Here, we report the results of a secondary endpoint, quality of life, of the LACC trial.
METHODS
The LACC trial was a randomised, open-label, phase 3, non-inferiority trial done in 33 centres worldwide. Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy. Participants were randomly assigned (1:1) to receive open or minimally invasive radical hysterectomy. Randomisation was done centrally using a computerised minimisation program, stratified by centre, disease stage according to FIGO guidelines, and age. Neither participants nor investigators were masked to treatment allocation. The primary endpoint of the LACC trial was disease-free survival at 4·5 years, and quality of life was a secondary endpoint. Eligible patients completed validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical [FACT-Cx], EuroQoL-5D [EQ-5D], and MD Anderson Symptom Inventory [MDASI]) before surgery and at 1 and 6 weeks and 3 and 6 months after surgery (FACT-Cx was also completed at additional timepoints up to 54 months after surgery). Differences in quality of life over time between treatment groups were assessed in the modified intention-to-treat population, which included all patients who had surgery and completed at least one baseline (pretreatment) and one follow-up (at any timepoint after surgery) questionnaire, using generalised estimating equations. The LACC trial is registered with ClinicalTrials.gov, NCT00614211.
FINDINGS
Between Jan 31, 2008, and June 22, 2017, 631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group. 496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group). Median follow-up was 3·0 years (IQR 1·7-4·5). At baseline, no differences in the mean FACT-Cx total score were identified between the open surgery (129·3 [SD 18·8]) and minimally invasive surgery groups (129·8 [19·8]). No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]).
INTERPRETATION
Since recurrence rates are higher and disease-free survival is lower for minimally invasive radical hysterectomy than for open surgery, and postoperative quality of life is similar between the treatment groups, gynaecological oncologists should recommend open radical hysterectomy for patients with early stage cervical cancer.
FUNDING
MD Anderson Cancer Center and Medtronic.",2020,"No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]).
","['patients with early stage cervical cancer', '496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group', 'patients with cervical cancer after', '631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group', '33 centres worldwide', 'Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy', 'Between Jan 31, 2008, and June 22, 2017']","['open versus minimally invasive radical hysterectomy (LACC', 'radical hysterectomy', 'open or minimally invasive radical hysterectomy']","['quality of life', 'validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical', 'mean FACT-Cx total scores', 'postoperative quality of life', 'Quality of life', 'disease-free survival at 4·5 years, and quality of life', 'mean FACT-Cx total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0346202', 'cui_str': 'Adenosquamous carcinoma of cervix'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}]",631.0,0.221146,"No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frumovitz', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: mfrumovitz@mdanderson.org.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obermair', 'Affiliation': 'Queensland Centre for Gynaecological Cancer Research, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pareja', 'Affiliation': 'Instituto Nacional de Cancerología, Bogotá, Colombia; Clínica de Oncología Astorga, Medellín, Colombia.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.'}, {'ForeName': 'Reitan', 'Initials': 'R', 'LastName': 'Ribero', 'Affiliation': 'Erasto Gaertner Hospital, Curitiba, Brazil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isla', 'Affiliation': 'Instituto Nacional de Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rendon', 'Affiliation': 'Instituto de Cancerologia-Las Americas, Medellín, Colombia.'}, {'ForeName': 'Marcus Q', 'Initials': 'MQ', 'LastName': 'Bernadini', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, ON, Canada.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Buda', 'Affiliation': 'San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moretti-Marquez', 'Affiliation': 'Hospital Israelita Albert Einstein, Centro de Oncologia e Hematologia, São Paulo, Brazil.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Zevallos', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.'}, {'ForeName': 'Marcelo A', 'Initials': 'MA', 'LastName': 'Vieira', 'Affiliation': 'Barretos Cancer Hospital, São Paulo, Brazil.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Land', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nicklin', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30081-4']
2745,32502550,Linked-color imaging versus white-light colonoscopy in an organized colorectal cancer screening program.,"BACKGROUND AND AIMS
Linked-color imaging (LCI), a new image-enhancing technology emphasizing contrast in mucosal color, has been demonstrated to substantially reduce polyp miss-rate as compared with standard White-Light (WL) in tandem colonoscopy studies. Whether LCI increases adenoma detection rate (ADR) remains unclear.
METHODS
Consecutive subjects undergoing screening colonoscopy after fecal immunochemical test (FIT) positivity were 1:1 randomized to undergo colonoscopy with LCI or WL, both in high-definition systems. Insertion and withdrawal phases of each colonoscopy were carried out using the same assigned light. Experienced endoscopists from 7 Italian centers participated in the study. Randomization was stratified by gender, age, and screening round. The primary outcome measure was represented by ADR.
RESULTS
Of 704 eligible subjects, 649 (48.9% males, mean age +SD 60.8+7.3 years) were included and randomized to LCI (n=326) or WL (n=323) colonoscopy. The ADR was higher in the LCI (51.8%) than in the WL group (43.7%) (RR, 1.19; 95% CI, 1.01-1.40). The proportions of patients with advanced adenomas and sessile serrated lesions (SSL) were 21.2% and 8.6% in LCI and 18.9% and 5.9% in WL arm, respectively (p=NS for both comparisons). At multivariate analysis, LCI was independently associated with ADR, along with male gender, increasing age and adequate (Boston Bowel Preparation Scale >6) bowel preparation. At per-polyp analysis, the mean+SD number of adenomas per colonoscopy was comparable in the LCI and WL arm, whereas the corresponding figures for proximal adenomas was significantly higher in the LCI group (0.72+1.2 vs 0.55+1.07, p=0.05) CONCLUSION: In FIT positive patients undergoing screening colonoscopy, the routine use of LCI significantly increases ADR. [Clinicaltrials.gov no:NCT03690297].",2020,"The ADR was higher in the LCI (51.8%) than in the WL group (43.7%) (RR, 1.19; 95% CI, 1.01-1.40).","['Consecutive subjects undergoing screening colonoscopy after fecal immunochemical test (FIT) positivity', 'Experienced endoscopists from 7 Italian centers participated in the study', '704 eligible subjects, 649 (48.9% males, mean age +SD 60.8+7.3 years']","['WL', 'LCI', 'Linked-color imaging versus white-light colonoscopy', 'colonoscopy with LCI or WL, both in high-definition systems']","['mean+SD number of adenomas per colonoscopy', 'ADR', 'proximal adenomas', 'proportions of patients with advanced adenomas and sessile serrated lesions (SSL', 'adenoma detection rate (ADR']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",704.0,0.150298,"The ADR was higher in the LCI (51.8%) than in the WL group (43.7%) (RR, 1.19; 95% CI, 1.01-1.40).","[{'ForeName': 'Paggi', 'Initials': 'P', 'LastName': 'Silvia', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Radaelli', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy. Electronic address: francoradaelli01@gmail.com.'}, {'ForeName': 'Senore', 'Initials': 'S', 'LastName': 'Carlo', 'Affiliation': 'Epidemiology and screening Unit - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Maselli', 'Initials': 'M', 'LastName': 'Roberta', 'Affiliation': 'Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy.'}, {'ForeName': 'Amato', 'Initials': 'A', 'LastName': 'Arnaldo', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Andrisani', 'Initials': 'A', 'LastName': 'Gianluca', 'Affiliation': 'Digestive Endoscopy Unit, Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Di Matteo', 'Initials': 'DM', 'LastName': 'Francesco', 'Affiliation': 'Digestive Endoscopy Unit, Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Cecinato', 'Initials': 'C', 'LastName': 'Paolo', 'Affiliation': 'Unit of Gastroenterology and Digestive Endoscopy, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Grillo', 'Initials': 'G', 'LastName': 'Simone', 'Affiliation': 'Unit of Gastroenterology and Digestive Endoscopy, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Sereni', 'Initials': 'S', 'LastName': 'Giuliana', 'Affiliation': 'Unit of Gastroenterology and Digestive Endoscopy, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Sassatelli', 'Initials': 'S', 'LastName': 'Romano', 'Affiliation': 'Unit of Gastroenterology and Digestive Endoscopy, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Manfredi', 'Initials': 'M', 'LastName': 'Guido', 'Affiliation': 'Gastroenterology Department, ASST Maggiore Hospital, Crema, Italy.'}, {'ForeName': 'Alicante', 'Initials': 'A', 'LastName': 'Saverio', 'Affiliation': 'Gastroenterology Department, ASST Maggiore Hospital, Crema, Italy.'}, {'ForeName': 'Buscarini', 'Initials': 'B', 'LastName': 'Elisabetta', 'Affiliation': 'Gastroenterology Department, ASST Maggiore Hospital, Crema, Italy.'}, {'ForeName': 'Canova', 'Initials': 'C', 'LastName': 'Daniele', 'Affiliation': 'Gastroenterology Unit, San Bortolo Hospital, Azienda ULSS n.8 Berica, Vicenza, Italy.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Luisa', 'Affiliation': 'Gastroenterology Unit, San Bortolo Hospital, Azienda ULSS n.8 Berica, Vicenza, Italy.'}, {'ForeName': 'Pallini', 'Initials': 'P', 'LastName': 'Paolo', 'Affiliation': 'Gastroenterology Unit, San Bortolo Hospital, Azienda ULSS n.8 Berica, Vicenza, Italy.'}, {'ForeName': 'Iwatate', 'Initials': 'I', 'LastName': 'Mineo', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Rondonotti', 'Initials': 'R', 'LastName': 'Emanuele', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Repici', 'Initials': 'R', 'LastName': 'Alessandro', 'Affiliation': 'Epidemiology and screening Unit - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy; Humanitas University, Milan, Italy.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Cesare', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.044']
2746,32502559,Optimal timing of a second post-operative voiding trial in women with incomplete bladder emptying after vaginal reconstructive surgery: A randomized trial.,"OBJECTIVE
We aimed to compare the outcomes of a second voiding trial (VT) performed 2-4 days (earlier group) versus 7 days (later group) post-operatively in women with incomplete bladder emptying following vaginal prolapse surgery. Secondary aims included post-operative urinary tract infection (UTI) rates, total days with a catheter, and patient reported catheter bother between groups.
STUDY DESIGN
Across two sites, women undergoing multi-compartment vaginal repair were enrolled. Within 6 hours post-operatively, subjects had an active retrograde VT. Those who passed this VT exited the study; those who had persistent incomplete bladder emptying (postvoid residual >100ml) had a transurethral indwelling catheter placed and were randomized to return for an earlier (post-operative day 2-4) versus later (post-operative day 7) follow-up office VT. Subjects were followed for 6 weeks post-surgery. The primary outcome was the rate of unsuccessful repeat office VT. Secondary outcomes included rates of urinary tract infection, total days with a catheter and subjective catheter bother. A power calculation based on a projected 31% difference, a power of 0.8 and alpha of 0.05 revealed that 30 subjects were needed in each group.
RESULTS
A total of 102 subjects were enrolled: 38 exited on post-operative day 0, leaving 64 subjects for randomization (4 of whom withdrew after randomization). A comparison of data revealed that randomization was effective with no differences between the earlier and later groups in terms of demographic data or surgical procedures. Using an intention-to-treat analysis, women in the earlier group were more likely to be unsuccessful in their follow-up office VT (23.3%) compared to the later group (3.3%) with a risk difference of 20% [95% CI 3.56-36.44], relative risk of 7.00 [95% CI 0.92-53.47], p=0.02. A number needed to treat calculation found that for every 5 patients using a catheter for 7 days post-operatively, 1 case of persistent post-operative incomplete bladder emptying was prevented. Rates of catheter bother did not differ between groups at the time of the follow-up office VT or at 6 weeks, p=0.09 and p=0.20 respectively. UTI rates were higher in the earlier group but did not reach statistical significance (23% vs 7%, p=0.07). Regression analysis revealed that subjects who required additional pain medication refills were 9.6 times (95%CI 1.24, 73.77) more likely to have persistent incomplete bladder emptying after the follow-up office VT.
CONCLUSIONS
Women with incomplete bladder emptying following multi-compartment prolapse repair had a 7-fold higher risk of an unsuccessful repeat office VT if performed within 4 days of surgery as compared to 7 days. In addition, requiring additional prescriptions for analgesia increased the risk of an unsuccessful follow-up office VT.",2020,A comparison of data revealed that randomization was effective with no differences between the earlier and later groups in terms of demographic data or surgical procedures.,"['women with incomplete bladder emptying following vaginal prolapse surgery', 'women with incomplete bladder emptying after vaginal reconstructive surgery', 'women undergoing multi-compartment vaginal repair were enrolled', 'Those who passed this VT exited the study; those who had persistent incomplete bladder emptying (postvoid residual >100ml) had a', '102 subjects were enrolled: 38 exited on post-operative day 0, leaving 64 subjects for randomization (4 of whom withdrew after randomization']",['transurethral indwelling catheter placed'],"['rates of urinary tract infection, total days with a catheter and subjective catheter bother', 'additional pain medication refills', 'incomplete bladder emptying', 'post-operative urinary tract infection (UTI) rates, total days with a catheter, and patient reported catheter bother between groups', 'rate of unsuccessful repeat office VT', 'Rates of catheter bother', 'UTI rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0344365', 'cui_str': 'Incomplete emptying of bladder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205990', 'cui_str': 'Vaginal wall prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1288276', 'cui_str': 'Vaginoplasty'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0344365', 'cui_str': 'Incomplete emptying of bladder'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",102.0,0.290319,A comparison of data revealed that randomization was effective with no differences between the earlier and later groups in terms of demographic data or surgical procedures.,"[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Schachar', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ossin', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, Department of Gynecology, Cleveland Clinic Florida.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Plair', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hurtado', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, Department of Gynecology, Cleveland Clinic Florida.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Parker-Autry', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Badlani', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health.'}, {'ForeName': 'G Willy', 'Initials': 'GW', 'LastName': 'Davila', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, Department of Gynecology, Cleveland Clinic Florida.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Matthews', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery, Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health. Electronic address: CAMatthe@wakehealth.edu.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.001']
2747,32502564,What is the impact of engaging with natural environments delivered via virtual reality on the psycho-emotional health of people with spinal cord injury receiving rehabilitation in hospital? Findings from a pilot randomized controlled trial.,"OBJECTIVES
This study investigated (i) the impact of engaging with 20 minute simulated natural environments delivered via virtual reality (VR) on current mood state, and (ii) the impact of engaging with multiple VR sessions over a period of a week on the depressive symptoms of people with a SCI.
DESIGN
A randomized controlled trial design was utilised.
SETTING
Spinal Cord Injury Rehabilitation Unit in Australia PARTICIPANTS: Participants (n=24) were assigned to a group engaging in VR sessions during week 1 (Group 1, n=10), or week 2 (Group 2, n=14).
INTERVENTIONS
The intervention week involved participation in up to three 20-minute VR sessions over three consecutive days. The control condition involved regular rehabilitation practice over a week.
MAIN OUTCOME MEASURES
The Patient Health Questionnaire-8 (PHQ-8) was completed prior to the first week (T1), after the first week and prior to the second week (T2), and after the second week (T3). Current feeling states- depressed/happy, anxious/relaxed, and not feeling good/feeling good - were rated immediately prior and after each VR session.
RESULTS
Levels of happiness, relaxation, and feeling good, were significantly higher subsequent to engaging with each VR session. Between-group differences in PHQ-8 scores were significantly greater for participants who experienced the intervention during the first week compared to participants within the control group: intervention participants had significant improvements in psycho-emotional health. Within-group PHQ-8 scores reduced for each group subsequent to experiencing the intervention, however differences were not significant.
CONCLUSIONS
Engaging with simulated natural environments delivered via VR can favourably impact the psycho-emotional health of people with SCI receiving rehabilitation in hospital. Future research including larger samples and investigating the impact over a longer time period is required to confirm the findings presented.",2020,"Within-group PHQ-8 scores reduced for each group subsequent to experiencing the intervention, however differences were not significant.
","['people with SCI receiving rehabilitation in hospital', 'Spinal Cord Injury Rehabilitation Unit in Australia', 'Participants (n=24', 'people with spinal cord injury receiving rehabilitation in hospital']","['engaging with 20 minute simulated natural environments delivered via virtual reality (VR', 'group engaging in VR sessions', 'natural environments delivered via virtual reality', 'engaging with multiple VR sessions']","['Levels of happiness, relaxation, and feeling good', 'psycho-emotional health', 'Patient Health Questionnaire-8 (PHQ-8', 'PHQ-8 scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0204101', 'cui_str': 'Spinal cord injury rehabilitation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0557745', 'cui_str': 'Natural environment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",24.0,0.0262716,"Within-group PHQ-8 scores reduced for each group subsequent to experiencing the intervention, however differences were not significant.
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Lakhani', 'Affiliation': 'The School of Psychology and Public Health, La Trobe University, City Campus, 360 Collins Street, Melbourne, Victoria, Australia, 3008; The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Logan Campus, University Drive, Meadowbrook, Queensland, Australia, 4131. Electronic address: a.lakhani@latrobe.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'PA Hospital, Occupational Therapy Department Metro South Health, Division of Rehabilitation, 199 Ipswich Rd, Woolloongabba, Queensland, Australia, 4102.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'PA Hospital, Occupational Therapy Department Metro South Health, Division of Rehabilitation, 199 Ipswich Rd, Woolloongabba, Queensland, Australia, 4102.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mallison', 'Affiliation': 'Western Sydney University, Locked Bag 1797, Penrith, New South Wales, Australia, 2751.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Grimbeek', 'Affiliation': 'Upper Brookfield, Brisbane, Queensland, Australia 4069.'}, {'ForeName': 'Izak', 'Initials': 'I', 'LastName': 'Hollins', 'Affiliation': 'The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Logan Campus, University Drive, Meadowbrook, Queensland, Australia, 4131.'}, {'ForeName': 'Col', 'Initials': 'C', 'LastName': 'Mackareth', 'Affiliation': 'Spinal Life Australia, 109 Logan Road, Woolloongabba, Queensland, Australia, 4102.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.013']
2748,32502588,"Efficacy and Patient-Reported Outcomes from a Phase IIb, Randomized Clinical Trial of Tapinarof Cream for the Treatment of Adolescents and Adults with Atopic Dermatitis.","BACKGROUND
Tapinarof is a topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) under investigation for atopic dermatitis (AD) and psoriasis treatment.
METHODS
Phase IIb, double-blind, vehicle-controlled study randomized adolescents and adults with AD to receive tapinarof cream 0.5%, 1%, or vehicle, once (QD) or twice daily (BID) for 12 weeks with 4-week follow-up. Outcomes included Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), body-surface area (BSA) affected, pruritus numeric rating scale scores, subject impressions of AD and pruritus symptom severity, and Patient-Oriented Eczema Measure (POEM) scores.
RESULTS
191/247 randomized subjects completed the study. Week-12 IGA responses were higher in tapinarof groups vs vehicle, reaching statistical significance with tapinarof 1%BID; ≥75/90% improvement in EASI from baseline were significantly higher in tapinarof groups (except 0.5%QD and 0.5%BID, respectively); EASI scores were significantly improved in all tapinarof groups; BSA affected was significantly reduced in tapinarof groups (except 0.5%BID). More subjects reported AD and pruritus symptom severity as very/moderately improved in tapinarof groups and POEM improvements were observed in all groups. Most adverse events were mild or moderate.
LIMITATIONS
Larger prospective studies are required to confirm reported analyses.
CONCLUSIONS
Tapinarof is a potential important advance in topical medicine development for AD.",2020,"Week-12 IGA responses were higher in tapinarof groups vs vehicle, reaching statistical significance with tapinarof 1%BID; ≥75/90% improvement in EASI from baseline were significantly higher in tapinarof groups (except 0.5%QD and 0.5%BID, respectively); EASI scores were significantly improved in all tapinarof groups; BSA affected was significantly reduced in tapinarof groups (except 0.5%BID).","['atopic dermatitis (AD) and psoriasis treatment', 'Adolescents and Adults with Atopic Dermatitis', 'adolescents and adults with AD to receive']","['Tapinarof Cream', 'tapinarof cream']","['AD and pruritus symptom severity', 'Week-12 IGA responses', 'EASI', 'Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), body-surface area (BSA) affected, pruritus numeric rating scale scores, subject impressions of AD and pruritus symptom severity, and Patient-Oriented Eczema Measure (POEM) scores', 'EASI scores', 'POEM improvements']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4541381', 'cui_str': 'tapinarof'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4304942', 'cui_str': 'POEM - Patient-Oriented Eczema Measure'}]",,0.0715799,"Week-12 IGA responses were higher in tapinarof groups vs vehicle, reaching statistical significance with tapinarof 1%BID; ≥75/90% improvement in EASI from baseline were significantly higher in tapinarof groups (except 0.5%QD and 0.5%BID, respectively); EASI scores were significantly improved in all tapinarof groups; BSA affected was significantly reduced in tapinarof groups (except 0.5%BID).","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Electronic address: apaller@northwestern.edu.'}, {'ForeName': 'Linda Stein', 'Initials': 'LS', 'LastName': 'Gold', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Soung', 'Affiliation': 'Southern California Dermatology, Santa Ana, CA, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Tallman', 'Affiliation': 'Dermavant Sciences, Inc., Long Beach, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rubenstein', 'Affiliation': 'Dermavant Sciences, Inc., Durham, NC, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""SKiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough, ON, Canada.""}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.05.135']
2749,32502705,The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,"BACKGROUND
Current options for effective postoperative analgesia after renal transplantation are limited, due to altered renal clearance and the risk of renal damage. This study compared the analgesic effect of the transversus abdominis plane block, with or without dexmedetomidine, in renal transplant recipients.
MATERIALS AND METHODS
This prospective randomized double-blinded clinical trial was performed from November 2014 to March 2017. Patients were randomly divided into group C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine). Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia were measured at 2, 4, 6, 12 and 24 hours after surgery.
RESULTS
The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour. Morphine consumption was the highest in group C at all assessed time intervals (p < 0.01). By the 12th hour and 24th hour, morphine consumption (calculated by time interval) was the lowest in group RD (p < 0.05), while no statistical difference was found between groups C and R. The average time to first request of analgesia was the longest and shortest in group RD and group C, respectively (p < 0.01). The overall incidence of nausea and vomiting was the highest in group C (p < 0.05).
CONCLUSIONS
The transversus abdominis plane block reduced morphine consumption in the first 24 hours following renal transplantation, and the addition of dexmedetomidine provided a more effective analgesic effect.",2020,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"['renal transplant recipients', 'November 2014 to March 2017', 'renal transplantation']","['C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine', 'transversus abdominis plane block with or without dexmedetomidine', 'dexmedetomidine', 'transversus abdominis plane block, with or without dexmedetomidine']","['visual analogue pain score', 'Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia', 'nausea and vomiting', 'morphine consumption', 'effective analgesic effect', 'Morphine consumption', 'average time to first request of analgesia']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",,0.113764,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University, No.54 Xianlie South Road, 510060, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Hufei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China. Electronic address: mysjz1@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.073']
2750,32502713,Simulation-based Arthroscopic Skills Using a Spaced Retraining Schedule Reduces Short-term Task Completion Time and Camera Path Length.,"PURPOSE
The aim of this study was to investigate whether acquiring basic knee arthroscopic skills via a spaced retraining schedule could prevent skills deterioration and achieve further skills improvement.
METHODS
In the learning phase, sixteen residents with no previous hands-on experience in practicing arthroscopic skills were asked to perform basic arthroscopic tasks on a simulator until they attained perfect scores in each task. Immediately after completing the learning phase, a pretest was performed to assess their performance. Next, they were randomly assigned into two groups. The spaced retraining group, which undertook a spaced repetitive training phase with a fixed-time interval, returned on Day 2, 4 and 6 to repeat the same tasks for 20 minutes per day, while the control group did nothing. On Day 7, all participants performed a posttest. A 2 × 2 mixed ANOVA model was used for statistical analysis.
RESULTS
Significant differences between the 2 groups were found in task completion time (P=0.003) and camera path length (P=0.043) but not cartilage injury (P=0.186). Residents in the spaced retraining group decreased their task completion time (163.2 ± 23.9 s) whereas the task time in the control group increased (351.3 ± 25.5 s). The same pattern was found with the camera path length.
CONCLUSIONS
Implementing a spaced retraining schedule in 1 week resulted in a reduced task completion time and camera path length, but no significant reduction in cartilage injury. It appears that introducing a spaced retraining schedule in order to retain arthroscopic skills acquired through massed learning may be advantageous.",2020,"RESULTS
Significant differences between the 2 groups were found in task completion time (P=0.003) and camera path length (P=0.043) but not cartilage injury (P=0.186).",['sixteen residents with no previous hands-on experience in practicing arthroscopic skills'],[],"['task time', 'camera path length', 'task completion time', 'skills deterioration and achieve further skills improvement', 'reduced task completion time and camera path length', 'cartilage injury', 'Short-term Task Completion Time and Camera Path Length']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0852694', 'cui_str': 'Injury of cartilage'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.0167901,"RESULTS
Significant differences between the 2 groups were found in task completion time (P=0.003) and camera path length (P=0.043) but not cartilage injury (P=0.186).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Orthopedics, Zhujiang Hospital, Southern Medical University, 253 Industrial Avenue, Haizhu, Guangzhou 510280, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Kai-Jun', 'Affiliation': 'The Second Clinical Medical School, Southern Medical University, Baiyun, Guangzhou, 510515, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Shun', 'Affiliation': 'The Second Clinical Medical School, Southern Medical University, Baiyun, Guangzhou, 510515, China.'}, {'ForeName': 'Xie', 'Initials': 'X', 'LastName': 'Xiaobo', 'Affiliation': 'Department of Orthopedics, Zhujiang Hospital, Southern Medical University, 253 Industrial Avenue, Haizhu, Guangzhou 510280, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Weiyu', 'Affiliation': 'Department of Orthopedics, Zhujiang Hospital, Southern Medical University, 253 Industrial Avenue, Haizhu, Guangzhou 510280, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei-Bin', 'Affiliation': 'Clinical Skills Training Center, Zhujiang Hospital, Southern Medical University, 253 Industrial Avenue, Haizhu, Guangzhou 510280, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Jing', 'Affiliation': 'Department of Orthopedics, Zhujiang Hospital, Southern Medical University, 253 Industrial Avenue, Haizhu, Guangzhou 510280, China. Electronic address: tianjing_ortho@163.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.040']
2751,32502730,Clinical outcome of short term compression following sclerotherapy of teleangiectatic varicose veins.,"BACKGROUND
Sclerotherapy is considered to be the method of choice for the treatment of teleangiectatic varicose veins (C1 veins). Whilst the use of compression stockings post sclerotherapy is recommended, little is known about the impact of compression on the outcome of sclerotherapy.
AIM
To assess the influence of compression on the outcome of injection sclerotherapy of C1 varicose veins.
METHODS
100 legs of 50 consecutive patients with chronic venous insufficiency (C1) were included. After randomization per patient both legs were treated with sclerotherapy in a predefined area of the thigh (measuring 100cm 2 ) followed by eccentric compression for 24 hours. Group A was additionally equipped with compression stockings with 18-20mm Hg above the ankle and continued wearing these for one week, whereas Group B received no further compression. Photodocumentation was performed before, one, and four weeks after sclerotherapy and the clinical outcome assessed at these post procedure follow up dates. The photographs were reviewed by an internal unblinded and an independent blinded external rater.
RESULTS
There was no discernable difference between the groups in terms of clinical outcome or side effects after 4 weeks. Whilst interrater reliability was high, there was no correlation between the raters and patients in terms of outcome. In 55% of the treated legs, the patients deemed the result of the treatment to be good, in 27% of the treated legs as fair, and in 18% poor. Post procedure hyperpigmentation occurred in 13% of patients and was comparable in both groups. Compression therapy was found to be comfortable by the majority (58%) of patients.
CONCLUSION
One week of post-interventional compression therapy had no clinical benefit compared to no compression.",2020,There was no discernable difference between the groups in terms of clinical outcome or side effects after 4 weeks.,"['100 legs of 50 consecutive patients with chronic venous insufficiency (C1', 'teleangiectatic varicose veins']","['sclerotherapy', 'compression stockings post sclerotherapy', 'Compression therapy', 'compression stockings']","['Post procedure hyperpigmentation', 'clinical outcome or side effects']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}]","[{'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",50.0,0.0228149,There was no discernable difference between the groups in terms of clinical outcome or side effects after 4 weeks.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bayer', 'Affiliation': 'Department of Surgery, University Medical Centre Schleswig-Holstein, Campus Luebeck, Ratzeburger Allee 160, 23538, Luebeck, Germany and Institute of Anatomy, Christian-Albrechts-University of Kiel, 24118 Kiel, Germany. Electronic address: a.bayer@anat.uni-kiel.de.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kuznik', 'Affiliation': 'Department of Dermatology, University Medical Centre Schleswig-Holstein, Campus Luebeck, Ratzeburger Allee 160, 23538, Luebeck, Germany.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Langan', 'Affiliation': 'Department of Dermatology, University Medical Centre Schleswig-Holstein, Campus Luebeck, Ratzeburger Allee 160, 23538, Luebeck, Germany; Dermatological Sciences, University of Manchester, Oxford Rd, Manchester, M13 9PL, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Recke', 'Affiliation': 'Department of Dermatology, University Medical Centre Schleswig-Holstein, Campus Luebeck, Ratzeburger Allee 160, 23538, Luebeck, Germany.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Recke', 'Affiliation': 'Department of Dermatology, University Medical Centre Schleswig-Holstein, Campus Luebeck, Ratzeburger Allee 160, 23538, Luebeck, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Faerber', 'Affiliation': 'Center for vascular medicine, Paul-Dessau-Straße 3E, 22761 Hamburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kaschwich', 'Affiliation': 'Department of Surgery, University Medical Centre Schleswig-Holstein, Campus Luebeck, Ratzeburger Allee 160, 23538, Luebeck, Germany and Institute of Anatomy, Christian-Albrechts-University of Kiel, 24118 Kiel, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kleemann', 'Affiliation': 'Department of Surgery, University Medical Centre Schleswig-Holstein, Campus Luebeck, Ratzeburger Allee 160, 23538, Luebeck, Germany and Institute of Anatomy, Christian-Albrechts-University of Kiel, 24118 Kiel, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kahle', 'Affiliation': 'Department of Dermatology, University Medical Centre Schleswig-Holstein, Campus Luebeck, Ratzeburger Allee 160, 23538, Luebeck, Germany.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.05.015']
2752,32502772,The impact of copper impregnated wound dressings on surgical site infection following caesarean section: a double blind randomised controlled study.,"OBJECTIVE
To investigate the effect of copper impregnated wound dressings on the surgical site infection (SSI) rate following caesarean section (CS).
DESIGN
Single centre double blind randomised controlled trial.
PARTICIPANTS
Women aged 18 years or over who had a CS.
INTERVENTIONS
All women were randomised to receive either a copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group).
MAIN OUTCOME MEASURES
The primary study outcome was the incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire. Secondary outcomes were length of hospital stay, and readmission rate.
RESULTS
324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group. The follow up rate was 97.5%. A total of 78 women (24.1%) developed an SSI within 30 days following CS; 29 (18.2%) in the study group and 49 (29.7%) controls (P = 0.037, relative risk reduction (RRR) of 38.7%). The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002). Length of hospital stay, and readmission rate did not vary significantly between groups.
CONCLUSIONS
This is the first study to demonstrate a significant reduction in SSI rates following CS with the use of copper impregnated wound dressings. The high SSI rate confirms the importance of new strategies to reduce the infection rate. Copper is a natural remedy which could potentially reduce hospital acquired infections without the use of antibiotics and its associated risks of antibiotic resistance.",2020,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","['Women aged 18 years or over who had a CS', '324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group', 'surgical site infection following caesarean section']","['caesarean section (CS', 'copper impregnated wound dressings', 'copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group']","['SSI rates', 'infection rate', 'length of hospital stay, and readmission rate', 'incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire', 'surgical site infection (SSI) rate', 'Length of hospital stay, and readmission rate', 'incidence of superficial/deep SSI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0056598', 'cui_str': 'Cupric oxide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",324.0,0.239103,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","[{'ForeName': 'Linda P', 'Initials': 'LP', 'LastName': 'Arendsen', 'Affiliation': 'Research Fellow, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: l.p.arendsen@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Consultant Obstetrician and Urogynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: ranee.thakar@nhs.net.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, Amersham, United Kingdom. Electronic address: paul@statsconsultancy.co.uk.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': ""Consultant Obstetrician and UroGynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, Croydon, CR7 7YE, United Kingdom Honorary Reader, St George's University of London. Electronic address: abdulsultan@nhs.net.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.016']
2753,32502775,"Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial.","STUDY OBJECTIVE
Comparison of ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB) in patients undergoing total hip arthroplasty (THA).
DESIGN
Randomized equivalence trial.
SETTING
University Hospital.
PATIENTS
Sixty patients undergoing primary THA.
INTERVENTIONS
Patients were randomly allocated to receive ultrasound-guided LPB (n = 30) or SIFIB (n = 30). The local anesthetic agent (40 mL of levobupivacaine 0.25% with epinephrine 5 μg/mL) and block adjuvant (4 mg of intravenous dexamethasone) were identical in all subjects. Postoperatively, all patients received patient-controlled intravenous analgesia (morphine) as well as acetaminophen and ketoprofen during 48 h.
MEASUREMENTS
A blinded investigator recorded morphine consumption at 24 and 48 h as well as time to first morphine request, pain scores at 3, 6, 12, 24 and 48 h, incidence of adverse events, time to readiness for discharge, and length of hospital stay. The blinded investigator also carried out sensorimotor block assessment at 3, 6 and 24 h using a 10-point sensorimotor composite scale.
MAIN RESULTS
No intergroup differences were found in terms of cumulative morphine consumption at 24 h (95% CI: -4.0 mg to 2.0 mg) and 48 h (95% CI, -5.0 mg to 2.0 mg) or time to first morphine request. Furthermore, pain scores were similar at all time intervals after 3 h. There were no intergroup differences in terms of composite sensorimotor scores at 3 and 6 h. However, SIFIB lasted longer than lumbar plexus block as evidenced by a higher composite score at 24 h. No intergroup differences were found in terms of complications. Compared with LPB, SIFIB was associated with shorter time to readiness for discharge (3 [1-4] vs. 2 [1-3] days; P = 0.042) and length of hospital stay (3 [2-5] vs. 3 [2-4] days; P = 0.048).
CONCLUSIONS
For THA, no differences were found between LPB and SIFIB in terms of breakthrough morphine requirement and pain control. However, SIFIB resulted in a longer block and was associated with shorter time to readiness for discharge as well as decreased hospital stay.",2020,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"['Sixty patients undergoing primary THA', 'University Hospital', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['block adjuvant (4\xa0mg of intravenous dexamethasone', 'acetaminophen and ketoprofen', 'levobupivacaine', 'ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB', 'epinephrine', 'patient-controlled intravenous analgesia (morphine', 'ultrasound-guided LPB', 'Lumbar plexus block versus suprainguinal fascia iliaca block']","['shorter time to readiness for discharge', 'breakthrough morphine requirement and pain control', 'cumulative morphine consumption', 'length of hospital stay', 'complications', 'composite sensorimotor scores', 'adverse events, time to readiness for discharge, and length of hospital stay', 'hospital stay', 'Furthermore, pain scores', 'morphine consumption at 24 and 48\xa0h as well as time to first morphine request, pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394731', 'cui_str': 'Lumbar plexus block'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",60.0,0.130543,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456. Electronic address: dbravoadvis@uchile.cl.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Jara', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Cristián', 'Initials': 'C', 'LastName': 'Barrientos', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Wulf', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Muñoz', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Montreal General Hospital, Department of Anesthesiology, McGill University, 1650 Ave Cedar, D10-D144, Montreal, Quebec H3G-1A4, Canada.'}, {'ForeName': 'De Q', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': ""St. Mary's Hospital, Department of Anesthesiology, McGill University, 3830 Ave Lacombe, Montreal, Quebec H3T-1M5, Canada.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109907']
2754,32502795,Comparison of underwater gait training and overground gait training for improving the walking and balancing ability of patients with severe hemiplegic stroke: A randomized controlled pilot trial.,"BACKGROUND
Walking training is an essential intervention to improve the function in stroke patients. However, only a limited number of gait training strategies are available for stroke patients with relatively severe disabilities.
RESEARCH QUESTION
Is underwater gait training or overground gait training more effective in severe stroke patients?
METHODS
A total of 21 patients with severe hemiplegic stroke were randomly assigned to the experimental and control groups. All participants (n = 21) received 60-minute sessions of general physical therapy, 5 times a week for a period of 12 weeks. Additionally, the experimental and control groups underwent underwater and overground walking training, respectively, for 30 min twice times a week for 12 weeks. Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity were measured before and after the 12-week training.
RESULTS
Both groups showed a significant decrease in the center of pressure path length and velocity after the intervention compared to the values before the intervention (p < .05). However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05). In the walking variables, the step length difference changes after training between the two groups showed a significant difference (p < .05). In the experimental group, the step length difference increased after the intervention compared to that before the intervention (+4.55 cm), whereas that of the control group decreased (-1.25 cm).
SIGNIFICANCE
In severe stroke patients, underwater gait training can be effective for improving balancing ability, but it may be less effective on the improvement of gait function than overground walking.
CLINICAL TRIAL REGISTRATION NUMBER
KCT0002587 (https://cris.nih.go.kr).",2020,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","['21 patients with severe hemiplegic stroke', 'stroke patients', 'severe stroke patients', 'stroke patients with relatively severe disabilities', 'patients with severe hemiplegic stroke']","['Walking training', 'underwater gait training', '60-minute sessions of general physical therapy', 'underwater and overground walking training', 'underwater gait training and overground gait training', 'underwater gait training or overground gait training']","['center of pressure path length and velocity', 'Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity', 'gait function', 'center of pressure path length and velocity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",21.0,0.0299419,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","[{'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: kimnan1004@hanmail.net.'}, {'ForeName': 'Hoon-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: phy9234@naver.com.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: thswlsrb1004@naver.com.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: moyo2ng@naver.com.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: jhlee@dju.kr.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: cha0874@dju.kr.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.022']
2755,32502876,Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study.,"BACKGROUND
Brentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/kg once every 3 weeks; ≤16 cycles) versus physician's choice (methotrexate/bexarotene; ≤48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined.
METHODS
QoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires.
RESULTS
Mean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (-27.96 versus -8.62); the difference, -18.9 (95% confidence interval -26.6, -11.2; adjusted p < 0.001), exceeded the study-defined minimally important difference (9.0-12.3). Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29). EQ-5D changes were also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was -35.54 versus -11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores.
CONCLUSIONS
In summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients.
CLINICAL TRIAL REGISTRATION
NCT01578499.",2020,Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29).,"['patients with relapsed/refractory cutaneous T-cell lymphoma', 'adult patients with CD30-expressing\xa0cutaneous T-cell lymphoma treated with prior']","[""physician's choice (methotrexate/bexarotene"", 'Cancer Therapy-General', 'European QoL 5-dimension', 'systemic therapy']","['quality of life', 'Skindex-29 symptom domain', 'FACT-G and EQ-5D QoL scores', 'Quality of life (QoL', 'EQ-5D changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0079773', 'cui_str': 'Cutaneous T-cell lymphoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0054950', 'cui_str': 'Lymphocyte antigen CD30'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0765273', 'cui_str': 'bexarotene'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.118026,Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29).,"[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Universitäts Spital Zürich, Rämistrasse 100, Zürich 8091, Switzerland. Electronic address: reinhard.dummer@usz.ch.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': ""Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, Victoria 8066, Australia. Electronic address: miles.prince@petermac.org.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Whittaker', 'Affiliation': 'Division of Genetics and Molecular Medicine, Faculty of Life Sciences and Medicine, Kings College London & Guys and St Thomas NHS Foundation Trust, London, UK. Electronic address: sean.whittaker@gstt.nhs.uk.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Horwitz', 'Affiliation': 'Memorial Hospital, 1275 York Avenue, Between 67th and 68th Streets, New York, NY 10065, USA. Electronic address: horwitzs@MSKCC.ORG.'}, {'ForeName': 'Youn H', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Stanford Clinical Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. Electronic address: younkim@stanford.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Scarisbrick', 'Affiliation': 'Nuffield House, Dermatology - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham B15 2TH, UK. Electronic address: Julia.Scarisbrick@uhb.nhs.uk.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Quaglino', 'Affiliation': 'University of Turin, Turin, Italy. Electronic address: Pietro.quaglino@unito.it.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology ""Seràgnoli"", University of Bologna, Via Massarenti 9, Bologna 40138, Italy. Electronic address: pierluigi.zinzani@unibo.it.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wolter', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium. Electronic address: pascalwolter@hotmail.com.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': 'Hematology Oncology, UCLA Lymphoma Program, Bone Marrow Transplant Program, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: Heradat@mednet.ucla.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Pinter-Brown', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA. Electronic address: lpinterb@uci.edu.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Sanches', 'Affiliation': 'Division of Clinical Dermatology, Hospital Das Clinicas, FMUSP, Department of Dermatology, University of Sao Paulo Medical School, Brazil. Electronic address: jasanchesjr@gmail.com.'}, {'ForeName': 'Pablo L', 'Initials': 'PL', 'LastName': 'Ortiz-Romero', 'Affiliation': 'University Hospital 12 de Octubre, Institute i+12, Medical School, Universidad Complutense, Madrid, Spain. Electronic address: portiz.hdoc@salud.madrid.org.'}, {'ForeName': 'Oleg E', 'Initials': 'OE', 'LastName': 'Akilov', 'Affiliation': 'University of Pittsburgh School of Medicine, Biomedical Science Tower, Room E1157, 200 Lothrop Street, Pittsburgh, PA 15261-2109, USA. Electronic address: akilovoe@upmc.edu.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Geskin', 'Affiliation': 'Department of Dermatology, Columbia University and CUMC, 161 Fort Washington Ave, 12th Floor, New York, NY 10032, USA. Electronic address: ljg2145@cumc.columbia.edu.'}, {'ForeName': 'Auris', 'Initials': 'A', 'LastName': 'Huen', 'Affiliation': 'University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: aohuen@mdanderson.org.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, 5 WK Roentgen Str, Warszawa 02-781, Poland. Electronic address: jan.walewski@coi.pl.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: ywang@seagen.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lisano', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: jlisano@seagen.com.'}, {'ForeName': 'Akshara', 'Initials': 'A', 'LastName': 'Richhariya', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: arichhariya@seagen.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Feliciano', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: felicianojoseph1@gmail.com.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Yanyan.Zhu@takeda.com.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Bunn', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Veronica.Bunn@takeda.com.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: meredith.little@takeda.com.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Zagadailov', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: erin.zagadailov@gmail.com.'}, {'ForeName': 'Mehul R', 'Initials': 'MR', 'LastName': 'Dalal', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: mehul.dalal@takeda.com.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Duvic', 'Affiliation': 'University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: mduvic@mdanderson.org.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.010']
2756,32502882,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.,"Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"['patients with COVID-19', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs', '500 participants at 34 sites in Brazil', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', 'Angiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels', 'median days alive and out of the hospital at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.143314,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil. Electronic address: renato.lopes@dm.duke.edu.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil; Santa Casa de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.002']
2757,32502908,Effects of 1 mA and 2 mA transcranial direct current stimulation on working memory performance in healthy participants.,"Anodal transcranial current stimulation (tDCS) to the left dorsolateral prefrontal cortex (DLPFC) has been shown to enhance working memory (WM) in neuropsychiatric patients. In healthy populations, however, tDCS obtains inconclusive results, mostly due to heterogeneous study and stimulation protocols. Here, we approached these issues by investigating effects of tDCS intensity on simultaneous WM performance with three cognitive loads by directly comparing findings of two double-blind, cross-over, sham-controlled experiments. TDCS was administrated to the left DLPFC at intensity of 1 mA (Experiment 1) or 2 mA (Experiment 2), while participants completed a verbal n-back paradigm (1-, 2-, 3-back). Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load. The present study suggests that cognitive load rather than tDCS intensity could be a decisive factor for effects on WM. Moreover, it emphasizes the need of thorough investigation on study parameters to develop more efficient stimulation protocols.",2020,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","['healthy participants', 'neuropsychiatric patients']","['1\xa0mA and 2\xa0mA transcranial direct current stimulation', 'TDCS', 'Anodal transcranial current stimulation (tDCS']",['working memory performance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0450811,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Papazova', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany. Electronic address: Irina.papazova@med.uni-muenchen.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Wienert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Henning', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schwippel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Plewnia', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, BKH Augsburg, Medical Faculty, University of Augsburg, Germany.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102959']
2758,32502923,"A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.","OBJECTIVES
Efficacy, safety, pharmacokinetics (PK), and immunogenicity of the biosimilar candidate SB8 was compared to its reference product bevacizumab (BEV) in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.
METHODS
Patients were randomized (1:1) in a phase III, double-blind study to receive intravenous SB8 or BEV 15 mg/kg with paclitaxel/carboplatin every 3 weeks for 24 weeks, followed by SB8 or BEV maintenance monotherapy. The primary endpoint was best overall response rate (ORR) by 24 weeks. Secondary endpoints included survival outcomes, safety, PK, and immunogenicity.
RESULTS
763 patients (SB8, n = 379; BEV, n = 384) were randomized; baseline characteristics were well balanced. Best ORR in the FAS was 47.6% and 42.8%, and best ORR in the PPS was 50.1% and 44.8% for SB8 and BEV, respectively. The risk ratio of best ORR was 1.11 (90% CI, 0.975-1.269), and the risk difference in best ORR was 5.3% (95% CI, -2.2%-12.9%). Median survival outcomes were comparable between SB8 and BEV: progression-free survival was 8.50 vs 7.90 months, respectively (HR [95% CI], 0.99 [0.83-1.18]; p = 0.9338); overall survival was 14.90 vs 15.80 months, respectively (HR [95% CI], 1.03 [0.83-1.28]; p = 0.7713); and duration of response was 7.70 vs 7.00 months, respectively (HR [95% CI], 1.05 [0.81-1.37]; p = 0.6928). Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
CONCLUSION
This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio, with comparable safety, PK, and immunogenicity.",2020,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","['763 patients (SB8, n\u2009=\u2009379; BEV, n\u2009=\u2009384', 'Patients', 'patients with metastatic or recurrent nonsquamous non-small cell lung cancer']","['paclitaxel/carboplatin', 'bevacizumab (BEV', 'bevacizumab', 'intravenous SB8 or BEV 15']","['duration of response', 'Efficacy, safety, pharmacokinetics (PK), and immunogenicity', 'risk ratio of best ORR', 'Median survival outcomes', 'safety, PK, and immunogenicity', 'overall response rate (ORR', 'overall survival', 'Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity', 'FAS', 'efficacy, safety, pharmacokinetics, and immunogenicity', 'SB8 and BEV: progression-free survival', 'survival outcomes, safety, PK, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",763.0,0.560036,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Lung Clinic, Woehrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, St. Petersburg, Russian Federation. Electronic address: alexander_luft@mail.ru.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine. Electronic address: oncology@dsma.dp.ua.'}, {'ForeName': 'Serhii', 'Initials': 'S', 'LastName': 'Shevnia', 'Affiliation': 'Department of Chemotherapy, Podillia Regional Oncology Center, Vinnytsia, Ukraine. Electronic address: shevnia1969@gmail.com.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Oncology Department, Odessa Regional Oncology Center, Odessa, Ukraine. Electronic address: dtrukhin39@gmail.com.'}, {'ForeName': 'Nadezhda V', 'Initials': 'NV', 'LastName': 'Kovalenko', 'Affiliation': 'Oncology, Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russian Federation. Electronic address: kovalenkost@yandex.ru.'}, {'ForeName': 'Kakha', 'Initials': 'K', 'LastName': 'Vacharadze', 'Affiliation': 'Department of Phthisiatry, Research Institute of Clinical Medicine, Tbilisi, Georgia. Electronic address: kakhavacharadze@yahoo.com.'}, {'ForeName': 'Fülöp', 'Initials': 'F', 'LastName': 'Andrea', 'Affiliation': 'Department of Pulmonary Class and Bronchology, Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary. Electronic address: afulop64@gmail.com.'}, {'ForeName': 'Anatoliy', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Day Staing Department, Chernivtsi Regional Oncology Center, Chernivtsi, Ukraine. Electronic address: anatoliyhontsa@gmail.com.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: jihye24.choi@samsung.com.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: dh01.shin@samsung.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.027']
2759,32502940,"The EndoPredict score predicts response to neoadjuvant chemotherapy and neoendocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients from the ABCSG-34 trial.","BACKGROUND
Neoadjuvant chemotherapy (NaCT) and neoadjuvant endocrine therapy (NET) can reduce pre-operative tumour burden in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer. This prospective translational study assessed the ability of a 12-gene molecular score (MS; EndoPredict®) to predict response to NaCT or NET within the ABCSG-34 trial.
PATIENTS AND METHODS
Hormone receptor (HR)-positive, HER2-negative samples from patients in the ABCSG-34 randomized phase II trial were selected and EndoPredict testing was performed to generate a 12-gene MS. ABCSG-34 patients were assigned to receive either NaCT or NET based on menopausal status, HR expression, grade and Ki67. Response was measured by residual cancer burden (RCB).
RESULTS
Patients selected for NaCT generally had high-risk disease by 12-gene MS (125/134), while slightly more patients treated with NET had low-risk disease (44/83). Low-risk NaCT-treated and high-risk NET-treated tumours responded poorly (NPV 100% [95% CI 66.4%-100%] and NPV 92.3% [95% CI 79.1%-98.4%], respectively]. The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]).
CONCLUSIONS
The 12-gene MS predicted RCB after treatment with neoadjuvant therapies for patients with HR-positive, HER2-negative early-stage breast cancer. Tumours with low MS were unlikely to benefit from NaCT, whereas a high MS predicted resistance to NET. This additional biologic information can aid personalized treatment selection in daily practice and builds a strong rationale to use EndoPredict in biomarker-driven studies in the neoadjuvant setting.",2020,"The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]).
","['patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer', 'Hormone receptor (HR)-positive, HER2-negative samples from patients in the ABCSG-34 randomized phase', 'patients with HR-positive, HER2-negative early-stage breast cancer']","['neoadjuvant chemotherapy and neoendocrine therapy', 'NaCT', 'Neoadjuvant chemotherapy (NaCT) and neoadjuvant endocrine therapy (NET', 'NaCT or NET']","['residual cancer burden (RCB', 'high-risk disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0242594', 'cui_str': 'Residual Cancer'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0845297,"The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]).
","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Dubsky', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Breast Center St. Anna, Lucerne, Switzerland. Electronic address: peter.dubsky@hirslanden.ch.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Gynecology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Wette', 'Affiliation': 'Breast Center, Brustzentrum Kärnten, St. Veit, Austria.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Petru', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Pichler', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Disease, Rheumatology, Oncologic Center, Laboratory for Immunological and Molecular Cancer Research, Paracelsus Medical University, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Petzer', 'Affiliation': 'Internal Medicine I, Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinkum Linz Barmherzige Schwestern, Elisabethinen, Linz, Austria.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fesl', 'Affiliation': 'Department of Statistics, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Meek', 'Affiliation': 'Myriad Genetics, Inc., Salt Lake City, UT, USA.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Kronenwett', 'Affiliation': 'Myriad International GmbH, Cologne, Germany.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.020']
2760,32502969,Treatment of Childhood Obesity Based on Brazilian Dietary Guidelines Plus Energy Restriction: Protocol for a Randomized Clinical Trial (PAPPAS HUPE Study).,"BACKGROUND
The Food Guide for the Brazilian Population relies on natural or minimally processed foods mainly of plant origin such as beans and rice with low oil, salt, and sugar content and limited consumption of ultraprocessed foods. Reduction of ultraprocessed foods improves diet quality and energy consumption.
OBJECTIVE
The goal of this study is to evaluate the effectiveness of an intervention for the treatment of obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake.
METHODS
A parallel, randomized clinical trial will include children aged 7 to 12 years. Randomization will be performed in blocks of 10 individuals using computer-generated random sequence numbers. Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide. These activities will be conducted at the University Hospital Toy Library, located in the pediatric outpatient clinic. For the intervention group, in addition to the educational activities, an individualized food plan based on the nutritional recommendations of the Brazilian Society of Pediatrics will be prescribed and discussed with the mothers and fathers. The primary outcome of the study will be variations in body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference.
RESULTS
This project was funded by the National Council for Scientific and Technological Development in December 2017 (grant no 408333/2017-0). Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants. In addition to the patients referred by the national system of regulation, recruitment was made by medical outpatient referral and external indication. This is an ongoing study. We expect the results to be published in April 2020.
CONCLUSIONS
At the end of the project, in case of a positive result, a protocol for the treatment of obesity based on the Brazilian Food Guide will be proposed to the Unified Health System. A successful method to reduce childhood obesity is expected.
CLINICALTRIAL
Brazilian Registry of Clinical Trials RBR-3st5sn; http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn.
INTERNATIONAL REGISTERED REPORT
DERR1-10.2196/16170.",2019,Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide.,"['10 individuals using computer-generated random sequence numbers', 'obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake', 'Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants', 'children aged 7 to 12 years']",[],"['diet quality and energy consumption', 'body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference', 'childhood obesity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}]",,0.0560747,Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide.,"[{'ForeName': 'Joana Maia', 'Initials': 'JM', 'LastName': 'Brandao', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rua São Francisco Xavier, 524, 7° andar, bloco E, sala 6004, Maracanã, Rio de Janeiro, BR.'}, {'ForeName': 'Rosely', 'Initials': 'R', 'LastName': 'Sichieri', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rua São Francisco Xavier, 524, 7° andar, bloco E, sala 6004, Maracanã, Rio de Janeiro, BR.'}, {'ForeName': 'Simone Augusta', 'Initials': 'SA', 'LastName': 'Ribas', 'Affiliation': 'Department of Nutrition and Public Health, School of Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro, BR.'}, {'ForeName': 'Eliseu', 'Initials': 'E', 'LastName': 'Verly', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rua São Francisco Xavier, 524, 7° andar, bloco E, sala 6004, Maracanã, Rio de Janeiro, BR.'}, {'ForeName': 'Rosangela Alves', 'Initials': 'RA', 'LastName': 'Pereira', 'Affiliation': 'Department of Social and Applied Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro, BR.'}, {'ForeName': 'Inês Rugani Ribeiro De', 'Initials': 'IRR', 'LastName': 'Castro', 'Affiliation': 'Department of Social Nutrition, Nutrition Institute, State University of Rio de Janeiro, Rio de Janeiro, BR.'}, {'ForeName': 'Bruna Kulik', 'Initials': 'BK', 'LastName': 'Hassan', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rua São Francisco Xavier, 524, 7° andar, bloco E, sala 6004, Maracanã, Rio de Janeiro, BR.'}, {'ForeName': 'Alessandra Silva Dias De', 'Initials': 'ASD', 'LastName': 'Oliveira', 'Affiliation': 'Department of Social Nutrition, Nutrition Institute, State University of Rio de Janeiro, Rio de Janeiro, BR.'}, {'ForeName': 'Emanuele Souza', 'Initials': 'ES', 'LastName': 'Marques', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rua São Francisco Xavier, 524, 7° andar, bloco E, sala 6004, Maracanã, Rio de Janeiro, BR.'}, {'ForeName': 'Diana Barbosa', 'Initials': 'DB', 'LastName': 'Cunha', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rua São Francisco Xavier, 524, 7° andar, bloco E, sala 6004, Maracanã, Rio de Janeiro, BR.'}]",JMIR research protocols,['10.2196/16170']
2761,32502991,RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT): a prospective randomized controlled trial.,"OBJECTIVE
The RECO flow restoration (FR) device is a new stent retriever designed for rapid flow restoration in acute ischemic stroke (AIS) caused by large vessel occlusion (LVO). Here, the authors compared the efficacy and safety of the RECO device with the predicate Solitaire FR stent retriever.
METHODS
The RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT) was a multicenter, prospective, open randomized controlled trial. Patients with acute LVO at 7 Chinese stroke centers participated in the study. The primary efficacy endpoint was defined as a modified thrombolysis in cerebral infarction (mTICI) reperfusion grade ≥ 2 within three passes. The primary safety endpoint comprised any serious adverse device effect, symptomatic intracerebral hemorrhage (sICH), and any serious adverse event (SAE; defined as cerebral palsy or death) within 24 hours after the procedure. The secondary efficacy endpoints consisted of functional independence (modified Rankin Scale score 0-2), procedure duration, and 90-day all-cause mortality.
RESULTS
Between January 2014 and August 2016, 67 patients were randomly allocated to the RECO group and 69 patients to the Solitaire FR group. The primary efficacy endpoint (mTICI grade ≥ 2 within three passes) was similar in the two treatment groups (91% vs 87%, respectively, p = 0.5861), and the rate of reperfusion with an mTICI grade 2b/3 was 87% versus 75% (p = 0.1272). There were no serious adverse device effects in any patient. The rates of sICH (1.5% vs 7.2%, p = 0.1027) and SAEs (6.0% vs 1.4%, p = 0.2050) within 24 hours after the procedure were similar in the two treatment groups. There was no significant difference in the rate of functional independence (63% vs 46%, p = 0.0609) or 90-day all-cause mortality (13% vs 23%, p = 0.1848) or in procedure duration (85.39 ± 47.01 vs 89.94 ± 53.34 minutes, p = 0.5986) between the two groups.
CONCLUSIONS
The RECO stent retriever is effective and safe as a mechanical thrombectomy device for AIS due to LVO.Clinical trial registration no.: NCT01983644 (clinicaltrials.gov).",2020,"There was no significant difference in the rate of functional independence (63% vs 46%, p = 0.0609) or 90-day all-cause mortality (13% vs 23%, p = 0.1848) or in procedure duration (85.39 ± 47.01 vs 89.94 ± 53.34 minutes, p = 0.5986) between the two groups.
","['Patients with acute LVO at 7 Chinese stroke centers participated in the study', 'group and 69 patients to the Solitaire FR group', 'Between January 2014 and August 2016, 67 patients']","['RECO', 'RECO flow restoration (FR) device', 'RECO Flow Restoration Device Versus Solitaire FR']","['rate of functional independence', 'rate of reperfusion with an mTICI grade', '90-day all-cause mortality', 'efficacy and safety', 'primary efficacy endpoint (mTICI grade ≥ 2 within three passes', 'functional independence (modified Rankin Scale score 0-2), procedure duration, and 90-day all-cause mortality', 'serious adverse device effects', 'SAEs', 'serious adverse device effect, symptomatic intracerebral hemorrhage (sICH), and any serious adverse event (SAE; defined as cerebral palsy or death', 'rates of sICH', 'modified thrombolysis in cerebral infarction (mTICI) reperfusion grade ≥ 2 within three passes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0326603', 'cui_str': 'Solitaire'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0326603', 'cui_str': 'Solitaire'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",67.0,0.109286,"There was no significant difference in the rate of functional independence (63% vs 46%, p = 0.0609) or 90-day all-cause mortality (13% vs 23%, p = 0.1848) or in procedure duration (85.39 ± 47.01 vs 89.94 ± 53.34 minutes, p = 0.5986) between the two groups.
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': ""1Department of Neurosurgery, The First People's Hospital of Changzhou/The Third Affiliated Hospital of Soochow University, Changzhou.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': '2Department of Neurology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': '2Department of Neurology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou.'}, {'ForeName': 'Kaifu', 'Initials': 'K', 'LastName': 'Ke', 'Affiliation': '3Department of Neurology, The Affiliated Hospital of Nantong University, Nantong.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': '3Department of Neurology, The Affiliated Hospital of Nantong University, Nantong.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': '4Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': '5Department of Neurology, Zhongshan Hospital of Xiamen University, Xiamen.'}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': '5Department of Neurology, Zhongshan Hospital of Xiamen University, Xiamen.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""6Department of Imaging, Yangzhou No. 1 People's Hospital, Yangzhou; and.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""7Department of CCU, Daping Hospital, Chongqing, People's Republic of China.""}, {'ForeName': 'Jinggang', 'Initials': 'J', 'LastName': 'Xuan', 'Affiliation': ""1Department of Neurosurgery, The First People's Hospital of Changzhou/The Third Affiliated Hospital of Soochow University, Changzhou.""}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""1Department of Neurosurgery, The First People's Hospital of Changzhou/The Third Affiliated Hospital of Soochow University, Changzhou.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurosurgery,['10.3171/2020.3.JNS193356']
2762,32502998,Letter to the Editor. Random assignment of patients to intraoperative neuromonitoring for unruptured intracranial aneurysms?,,2020,,[],['intraoperative neuromonitoring'],[],[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",[],,0.0165742,,"[{'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Holdefer', 'Affiliation': '1University of Washington, Seattle, WA; and.'}, {'ForeName': 'LanJun', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': '2University of California, San Francisco, CA.'}]",Journal of neurosurgery,['10.3171/2020.4.JNS20970']
2763,32503004,"Effect of exercise training on insulin sensitivity, hyperinsulinemia and ectopic fat in black South African women: a randomized controlled trial.","Objective
We investigated the effects of a 12-week exercise intervention on insulin sensitivity (SI) and hyperinsulinemia and associated changes in regional and ectopic fat.
Research design and methods
Healthy, black South African women with obesity (mean age 23 ± 3.5 years) and of isiXhosa ancestry were randomised into a 12-week aerobic and resistance exercise training group (n = 23) and a no exercise group (control, n = 22). Pre and post-intervention testing included assessment of SI, insulin response to glucose (AIRg), insulin secretion rate (ISR), hepatic insulin extraction (FEL) and disposition index (DI) (AIRg × SI) (frequently sampled i.v. glucose tolerance test); fat mass and regional adiposity (dual-energy X-ray absorptiometry); hepatic, pancreatic and skeletal muscle fat content and abdominal s.c. and visceral adipose tissue volumes (MRI).
Results
Exercise training increased VO2peak (mean ± s.d.: 24.9 ± 2.42 to 27.6 ± 3.39 mL/kg/min, P < 0.001), SI (2.0 (1.2-2.8) to 2.2 (1.5-3.7) (mU/l)-1 min-1, P = 0.005) and DI (median (interquartile range): 6.1 (3.6-7.1) to 6.5 (5.6-9.2) × 103 arbitrary units, P = 0.028), and decreased gynoid fat mass (18.5 ± 1.7 to 18.2 ± 1.6%, P < 0.001) and body weight (84.1 ± 8.7 to 83.3 ± .9.7 kg, P = 0.038). None of these changes were observed in the control group, but body weight increased (P = 0.030). AIRg, ISR and FEL, VAT, SAT and ectopic fat were unaltered after exercise training. The increase in SI and DI were not associated with changes in regional or ectopic fat.
Conclusion
Exercise training increased SI independent from changes in hyperinsulinemia and ectopic fat, suggesting that ectopic fat might not be a principal determinant of insulin resistance in this cohort.",2020,"None of these changes were observed in the control group, but body weight increased (P = 0.030).","['black South African women', 'Healthy, black South African women with obesity (mean', 'age 23 ± 3.5 years) and of isiXhosa ancestry']","['exercise training', 'Conclusion\n\n\nExercise training', 'no exercise', 'exercise intervention', 'aerobic and resistance exercise training']","['insulin sensitivity (SI) and hyperinsulinemia', 'hyperinsulinemia and ectopic fat', 'body weight', 'AIRg, ISR and FEL, VAT, SAT and ectopic fat', 'insulin sensitivity, hyperinsulinemia and ectopic fat', 'SI', 'SI and DI', 'gynoid fat mass', 'assessment of SI, insulin response to glucose (AIRg), insulin secretion rate (ISR), hepatic insulin extraction (FEL) and disposition index (DI) (AIRg × SI', 'glucose tolerance test); fat mass and regional adiposity']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0272199', 'cui_str': 'Familial hemophagocytic lymphohistiocytosis'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.0228643,"None of these changes were observed in the control group, but body weight increased (P = 0.030).","[{'ForeName': 'Melony C', 'Initials': 'MC', 'LastName': 'Fortuin-de Smidt', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mendham', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hauksson', 'Affiliation': 'Department of Radiation Sciences, Radiation Physics and Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Olah', 'Initials': 'O', 'LastName': 'Hakim', 'Affiliation': ""Department of Diabetes, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Stefanovski', 'Affiliation': 'Department of Clinical Studies, New Bolton Center, University of Pennsylvania, School of Veterinary Medicine, Kennett Square, Pennsylvania, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Clamp', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lindokuhle', 'Initials': 'L', 'LastName': 'Phiri', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Swart', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Goff', 'Affiliation': ""Department of Diabetes, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Micklesfield', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Olsson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Goedecke', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}]",European journal of endocrinology,['10.1530/EJE-19-0957']
2764,32503005,Psychological well-being and personality in relation to weight loss following behavioral modification intervention in obese women with polycystic ovary syndrome: a randomized controlled trial.,"Objective
Little is known about how lifestyle affects psychological well-being in overweight women with polycystic ovary syndrome (PCOS). We investigated the effects of behavioral modification on psychological well-being and the impact of well-being and personality traits on successful weight loss.
Design
A 4-month randomized controlled trial with a 12-month follow-up at a University Hospital.
Methods
Sixty-eight women with PCOS, aged 18 to 40 years with a BMI ≥27 kg/m2, were randomized (1:1) into a behavioral modification program (intervention) or minimal intervention (control). The outcome measures were the psychological well being index and the Swedish universities scales of personality.
Results
At baseline, 60% had a global psychological well being index corresponding to severe distress and 40% to moderate distress. There was no significant change in mean global well-being score at 4 months within or between groups. However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033). Anxiety and general health tended to differ between groups (P = .06, respectively) favoring intervention. In the whole population, women achieving ≥5% weight loss at 12 months (n = 18) were less anxious at baseline compared to those who had not (P = .004). Personality trait-analysis showed that the weight-loss group had higher social desirability (P = .033) and lower embitterment (P = .023).
Conclusions
Psychological well-being is severely impacted in overweight women with PCOS. Behavioral modification can positively impact dimensions of well-being, although not fully significant, compared to control treatment. Personality factors could contribute to the understanding of successful weight loss.",2020,"However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033).","['obese women with polycystic ovary syndrome', 'overweight women with polycystic ovary syndrome (PCOS', 'Methods\n\n\nSixty-eight women with PCOS, aged 18 to 40 years with a BMI ≥27 kg/m2', 'overweight women with PCOS']","['behavioral modification intervention', 'behavioral modification program (intervention) or minimal intervention (control']","['global psychological well being index corresponding to severe distress', 'anxiety', 'weight loss', 'general health', 'Anxiety and general health', 'mean global well-being score', 'psychological well being index and the Swedish universities scales of personality', 'social desirability']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0037408', 'cui_str': 'Social Desirability'}]",68.0,0.0840157,"However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033).","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Oberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lundell', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Liselott', 'Initials': 'L', 'LastName': 'Blomberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Sebastian B', 'Initials': 'SB', 'LastName': 'Gidlöf', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Petra Tollet', 'Initials': 'PT', 'LastName': 'Egnell', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}]",European journal of endocrinology,['10.1530/EJE-20-0066']
2765,32503041,Odour reduction interventions for simple pit latrines in rural Ethiopia: a randomized study.,"Pit latrines are promoted in resource-limited settings, but unpleasant odours may deter their use. In this study, latrines in rural Ethiopia were randomized to the addition of cooking ash, the addition of boiling water or neither. Study staff ranked odour on a 6-point scale before and approximately 24 h after intervention. Following intervention, odour grades were on average 0.2 points lower (95% confidence interval [CI] 0.7 lower to 0.3 higher) in ash-treated latrines and 0.4 points lower (95% CI 0.9 lower to 0.1 higher) in boiled water-treated latrines, although the difference between the three groups was not statistically significant (p = 0.21). Larger studies might detect a smaller difference.",2020,"Following intervention, odour grades were on average 0.2 points lower (95% confidence interval [CI] 0.7 lower to 0.3 higher) in ash-treated latrines and 0.4 points lower (95% CI 0.9 lower to 0.1 higher) in boiled water-treated latrines, although the difference between the three groups was not statistically significant (p = 0.21).","['simple pit latrines in rural Ethiopia', 'latrines in rural Ethiopia']",['Odour reduction interventions'],[],"[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C3266595', 'cui_str': 'Pit latrine'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0023124', 'cui_str': 'Latrine'}]","[{'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0830342,"Following intervention, odour grades were on average 0.2 points lower (95% confidence interval [CI] 0.7 lower to 0.3 higher) in ash-treated latrines and 0.4 points lower (95% CI 0.9 lower to 0.1 higher) in boiled water-treated latrines, although the difference between the three groups was not statistically significant (p = 0.21).","[{'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Aragie', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Dionna M', 'Initials': 'DM', 'LastName': 'Wittberg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Aiemjoy', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Melo', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Meghan J', 'Initials': 'MJ', 'LastName': 'Smith', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Nash', 'Affiliation': 'The Carter Center, Atlanta, GA, USA.'}, {'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Tadesse', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}]",Transactions of the Royal Society of Tropical Medicine and Hygiene,['10.1093/trstmh/traa039']
2766,32503093,Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS.,"OBJECTIVE
To assess the safety of ocrelizumab (OCR) shorter duration infusion in patients with MS.
METHODS
ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early stage relapsing-remitting MS received OCR 600 mg initially as two 300 mg IV infusions 2 weeks apart and subsequently as a single 3.5-hour 600 mg infusion every 24 weeks for 192 weeks. In ENSEMBLE PLUS, OCR 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration). The primary end point was the proportion of patients with infusion-related reactions (IRRs) after the first randomized dose (assessed during and up to 24 hours postinfusion).
RESULTS
From November 1, 2018, to September 27, 2019, 580 patients were randomized 1:1 to the conventional or shorter infusion group. After the first randomized dose, 67 of 291 patients (23.1%) in the conventional and 71 of 289 patients (24.6%) in the shorter infusion group experienced IRRs. Most IRRs were mild or moderate in both groups; one patient in each group experienced a severe IRR, and in both groups, 98.6% (136 of 138) of all IRRs resolved without sequelae. No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuation occurred. During the first randomized dose, 14 of 291 (4.8%) and 25 of 289 (8.7%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption.
CONCLUSION
The frequency and severity of IRRs were similar between conventional and shorter OCR infusions. Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden.
CLASSIFICATION OF EVIDENCE
This interventional study provides Class I evidence that the frequency and severity of IRRs were similar at the first randomized dose using OCR (600 mg) infusions of conventional and shorter duration in patients with relapsing-remitting MS.
CLINICAL TRIAL IDENTIFIER NUMBER
NCT03085810.",2020,"Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden.
","['patients with MS', 'From November 1, 2018, to September 27, 2019, 580 patients', 'patients with relapsing-remitting MS', 'patients with early stage relapsing-remitting MS']","['OCR', 'conventional or shorter infusion group', 'Ocrelizumab', 'ocrelizumab (OCR']","['serious, life-threatening, or fatal', 'IRRs leading to infusion slowing/interruption', 'total infusion site stay time and lessens the overall patient and site staff burden', 'IRRs', 'severe IRR', 'proportion of patients with infusion-related reactions (IRRs', 'frequency and severity of IRRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",580.0,0.17746,"Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden.
","[{'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'From the Department of Neurology, UKD, Center of Neurology and Neuropsychiatry and LVR-Klinikum, Medical Faculty, Heinrich-Heine University Düsseldorf, Germany. hans-peter.hartung@uni-duesseldorf.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000807']
2767,32503194,Acupuncture Treatment Modulates the Connectivity of Key Regions of the Descending Pain Modulation and Reward Systems in Patients with Chronic Low Back Pain.,"Chronic low back pain (cLBP) is a common disorder with unsatisfactory treatment options. Acupuncture has emerged as a promising method for treating cLBP. However, the mechanism underlying acupuncture remains unclear. In this study, we investigated the modulation effects of acupuncture on resting state functional connectivity (rsFC) of the periaqueductal gray (PAG) and ventral tegmental area (VTA) in patients with cLBP. Seventy-nine cLBP patients were recruited and assigned to four weeks of real or sham acupuncture. Resting state functional magnetic resonance imaging data were collected before the first and after the last treatment. Fifty patients completed the study. We found remission of pain bothersomeness in all treatment groups after four weeks, with greater pain relief after real acupuncture compared to sham acupuncture. We also found that real acupuncture can increase VTA/PAG rsFC with the amygdala, and the increased rsFC was associated with decreased pain bothersomeness scores. Baseline PAG-amygdala rsFC could predict four-week treatment response. Our results suggest that acupuncture may simultaneously modulate the rsFC of key regions in the descending pain modulation (PAG) and reward systems (VTA), and the amygdala may be a key node linking the two systems to produce antinociceptive effects. Our findings highlight the potential of acupuncture for chronic low back pain management.",2020,"We found remission of pain bothersomeness in all treatment groups after four weeks, with greater pain relief after real acupuncture compared to sham acupuncture.","['Patients with Chronic Low Back Pain', 'Fifty patients completed the study', 'patients with cLBP', 'Seventy-nine cLBP patients']","['acupuncture', 'real or sham acupuncture', 'Acupuncture']","['remission of pain bothersomeness', 'pain relief', 'resting state functional connectivity (rsFC) of the periaqueductal gray (PAG) and ventral tegmental area (VTA', 'Chronic low back pain (cLBP', 'pain bothersomeness scores', 'Connectivity of Key Regions of the Descending Pain Modulation and Reward Systems', 'VTA/PAG rsFC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0228398', 'cui_str': 'Structure of periaqueductal gray matter'}, {'cui': 'C0175405', 'cui_str': 'Ventral Tegmental Area of Tsai'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",79.0,0.121085,"We found remission of pain bothersomeness in all treatment groups after four weeks, with greater pain relief after real acupuncture compared to sham acupuncture.","[{'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA 15206, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02467, USA.""}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}]",Journal of clinical medicine,['10.3390/jcm9061719']
2768,32503243,Randomized Trial of General Strength and Conditioning Versus Motor Control and Manual Therapy for Chronic Low Back Pain on Physical and Self-Report Outcomes.,"Exercise and spinal manipulative therapy are commonly used for the treatment of chronic low back pain (CLBP) in Australia. Reduction in pain intensity is a common outcome; however, it is only one measure of intervention efficacy in clinical practice. Therefore, we evaluated the effectiveness of two common clinical interventions on physical and self-report measures in CLBP. Participants were randomized to a 6‑month intervention of general strength and conditioning (GSC; n = 20; up to 52 sessions) or motor control exercise plus manual therapy (MCMT; n =20; up to 12 sessions). Pain intensity was measured at baseline and fortnightly throughout the intervention. Trunk extension and flexion endurance, leg muscle strength and endurance, paraspinal muscle volume, cardio‑respiratory fitness and self-report measures of kinesiophobia, disability and quality of life were assessed at baseline and 3- and 6-month follow-up. Pain intensity differed favoring MCMT between-groups at week 14 and 16 of treatment (both, p = 0.003), but not at 6-month follow‑up. Both GSC (mean change (95%CI): -10.7 (-18.7, -2.8) mm; p = 0.008) and MCMT (-19.2 (-28.1, -10.3) mm; p < 0.001) had within-group reductions in pain intensity at six months, but did not achieve clinically meaningful thresholds (20mm) within- or between‑group. At 6-month follow-up, GSC increased trunk extension (mean difference (95% CI): 81.8 (34.8, 128.8) s; p = 0.004) and flexion endurance (51.5 (20.5, 82.6) s; p = 0.004), as well as leg muscle strength (24.7 (3.4, 46.0) kg; p = 0.001) and endurance (9.1 (1.7, 16.4) reps; p = 0.015) compared to MCMT. GSC reduced disability (-5.7 (‑11.2, -0.2) pts; p = 0.041) and kinesiophobia (-6.6 (-9.9, -3.2) pts; p < 0.001) compared to MCMT at 6‑month follow-up. Multifidus volume increased within-group for GSC ( p = 0.003), but not MCMT or between-groups. No other between-group changes were observed at six months. Overall, GSC improved trunk endurance, leg muscle strength and endurance, self-report disability and kinesiophobia compared to MCMT at six months. These results show that GSC may provide a more diverse range of treatment effects compared to MCMT.",2020,"Overall, GSC improved trunk endurance, leg muscle strength and endurance, self-report disability and kinesiophobia compared to MCMT at six months.",['chronic low back pain (CLBP) in Australia'],"['GSC', 'Exercise and spinal manipulative therapy', '6‑month intervention of general strength and conditioning (GSC; n = 20; up to 52 sessions) or motor control exercise plus manual therapy (MCMT', 'General Strength and Conditioning Versus Motor Control and Manual Therapy']","['MCMT', 'endurance', 'Multifidus volume', 'flexion endurance', 'pain intensity', 'Trunk extension and flexion endurance, leg muscle strength and endurance, paraspinal muscle volume, cardio‑respiratory fitness and self-report measures of kinesiophobia, disability and quality of life', 'Pain intensity', 'Overall, GSC improved trunk endurance, leg muscle strength and endurance, self-report disability and kinesiophobia', 'kinesiophobia', 'leg muscle strength', 'GSC reduced disability', 'trunk extension']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C1621352', 'cui_str': 'DNMT1 Enzyme'}]","[{'cui': 'C1621352', 'cui_str': 'DNMT1 Enzyme'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0448353', 'cui_str': 'Deep muscle of back'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0653155,"Overall, GSC improved trunk endurance, leg muscle strength and endurance, self-report disability and kinesiophobia compared to MCMT at six months.","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Tagliaferri', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Clint T', 'Initials': 'CT', 'LastName': 'Miller', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Jon J', 'Initials': 'JJ', 'LastName': 'Ford', 'Affiliation': 'Advance HealthCare, 157 Scoresby Rd, Boronia, VIC 3155, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Hahne', 'Affiliation': 'Low Back Research Team, College of Science, Health & Engineering, La Trobe University, Bundoora, VIC 3083, Australia.'}, {'ForeName': 'Luana C', 'Initials': 'LC', 'LastName': 'Main', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rantalainen', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Connell', 'Affiliation': 'Imaging@Olympic Park, AAMI Park, 60 Olympic Boulevard, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Simson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Owen', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Belavy', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9061726']
2769,32503294,A Mixed Methods Evaluation of a Randomized Control Trial to Evaluate the Effectiveness of the Pure Prairie Living Program in Type 2 Diabetes Participants.,"The primary objective of this randomized control trial was to evaluate the effectiveness of the Pure Prairie Living Program (PPLP) in a primary care setting. Adults with type 2 diabetes were randomized into intervention (PPLP, n = 25) and wait-listed controls (CON, n = 24). The PPLP group participated in education sessions. The intervention yielded no significant within-group changes in HbA1c at three-month (-0.04 (-0.27 to 0.17) and -0.15 (-0.38 to 0.08)) or six-month (-0.09 (-0.41 to 0.22) and 0.06 (-0.26 to 0.38)) follow ups in either CON or PPLP groups, respectively. Dietary adherence scores improved in the PPLP group ( p < 0.05) at three and six months but were not different in the between-group comparison. No changes in diabetes self-efficacy scores were detected. In the qualitative analysis, participants described the program as clear and easy to understand. Knowledge acquired influenced their everyday decision making but participants faced barriers that prevented them from fully applying what they learned. Healthcare professionals enjoyed delivering the program but described the ""back-stage"" workload as detrimental. In conclusion, while some positive effects of the PPLP intervention were observed, they were not comparable to those previously attained by our group in an academic setting or to what the guidelines recommend, which reflects the challenge of translating lifestyle intervention to real-world settings.",2020,Dietary adherence scores improved in the PPLP group ( p < 0.05) at three and six months but were not different in the between-group comparison.,"['Type 2 Diabetes Participants', 'Adults with type 2 diabetes']","['Pure Prairie Living Program (PPLP', 'PPLP', 'Pure Prairie Living Program']","['Dietary adherence scores', 'diabetes self-efficacy scores']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0442534', 'cui_str': 'Prairie'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0301551,Dietary adherence scores improved in the PPLP group ( p < 0.05) at three and six months but were not different in the between-group comparison.,"[{'ForeName': 'M Carolina', 'Initials': 'MC', 'LastName': 'Archundia-Herrera', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, 6-002 Li Ka Shing Centre for Health Innovation Research, Edmonton, AB T6G 2E1, Canada.'}, {'ForeName': 'Fatheema B', 'Initials': 'FB', 'LastName': 'Subhan', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, AB T6G 2T4, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sakowsky', 'Affiliation': 'Sherwood Park Primary Care Network, 150 Broadway Crescent, Suite 108, Sherwood Park, AB T8H 0V3, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Watkins', 'Affiliation': 'Sherwood Park Primary Care Network, 150 Broadway Crescent, Suite 108, Sherwood Park, AB T8H 0V3, Canada.'}, {'ForeName': 'Catherine B', 'Initials': 'CB', 'LastName': 'Chan', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, 6-002 Li Ka Shing Centre for Health Innovation Research, Edmonton, AB T6G 2E1, Canada.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020153']
2770,32503365,Effect of Stress Management Counseling on Self-Efficacy and Continuity of Exclusive Breastfeeding.,"Background: Self-efficacy is an important motivational factor that can be affected by physiological responses such as stress. Objective: The study aimed to determine the effect of stress management counseling on self-efficacy and continuity of exclusive breastfeeding in mothers. Materials and Methods: This randomized controlled trial was carried out on 46 pregnant women recruited at three Childbirth Preparation Centers of Zanjan (Iran) in 2018. The eligible women were allocated into two intervention and control groups according to the block design. Stress management counseling was carried out individually in four sessions, twice a week at 35 and 36 weeks of gestation. The control group only received routine cares. The self-efficacy and continuity of exclusive breastfeeding were measured monthly up to 4 months after childbirth. Results: Breastfeeding self-efficacy showed a statistically significant difference between the two study groups at 1 and 4 months after childbirth ( p = 0.001). More women in the control group terminated exclusive breastfeeding compared to those in the intervention group (16 (72.7%) versus 8 (34.8%), p = 0.013). Conclusion: The results showed that integration of stress management counseling in breastfeeding education package can improve the self-efficacy and continuation of breastfeeding in mothers.",2020,"More women in the control group terminated exclusive breastfeeding compared to those in the intervention group (16 (72.7%) versus 8 (34.8%), p = 0.013). ","['46 pregnant women recruited at three Childbirth Preparation Centers of Zanjan (Iran) in 2018', 'mothers']","['routine cares', 'stress management counseling', 'Stress Management Counseling']","['exclusive breastfeeding', 'self-efficacy and continuity of exclusive breastfeeding', 'Self-Efficacy and Continuity of Exclusive Breastfeeding', 'self-efficacy and continuation of breastfeeding', 'Breastfeeding self-efficacy']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0150169', 'cui_str': 'Childbirth preparation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",46.0,0.0306649,"More women in the control group terminated exclusive breastfeeding compared to those in the intervention group (16 (72.7%) versus 8 (34.8%), p = 0.013). ","[{'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Azizi', 'Affiliation': 'Department of Midwifery, Social Determinants of Health Research Center, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Maleki', 'Affiliation': 'Department of Midwifery, Social Determinants of Health Research Center, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Mazloomzadeh', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Pirzeh', 'Affiliation': 'Department of Psychiatry, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0251']
2771,32503390,Effect of Hydrogen Peroxide Photoactivated Decontamination Using 940 nm Diode Laser in Periodontal Treatment: A Pilot Study.,"Objective: The aim of this study was to compare the antimicrobial effects of hydroxyl radical generation by photoactivation of hydrogen peroxide (H 2 O 2 ) with diode laser (λ = 940 nm) in combination with conventional nonsurgical periodontal therapy. Materials and methods: Thirty-eight patients and 114 teeth were included in this study. The test teeth were randomly assigned to one of the three treatment groups: Group 1 (control group): scaling and root planning (SRP); and the following experimental groups: Group 2: SRP +940 nm diode laser; Group 3: SRP+photoactivation of H 2 O 2 with 940 nm diode laser. Clinical examinations, such as periodontal probing depth (PPD), clinical attachment level (CAL), and bleeding on probing (BoP) were performed before and after the treatment. The microbiological evaluation included nine periodontal bacterial species investigated by means of real-time polymerase chain reaction assay before and after the treatment. The clinical and bacterial differences were assessed between the investigated groups. Results: The total bacteria load was reduced for all three studied groups and all periodontal indexes (PPD, CAL, and BoP) were improved after each treatment. Group 3 showed significant bacterial reduction of the major periodontal bacteria such as Porphyromonas gingivalis , Tannerella forsythia , Treponema denticola , Prevotella intermedia , Peptostreptococcus micros , Fusobacterium nucleatum , Eubacterium nodatum ( p < 0.001) in contrast to the other two groups ( p > 0.001). Differences between tested groups showed significant results with regard to Group 3. Conclusions: The synergistic effect of SRP and photoactivation of H 2 O 2 with 940 nm diode laser offers an efficient and reliable antimicrobial effect in the nonsurgical periodontal treatment approach.",2020,"The total bacteria load was reduced for all three studied groups and all periodontal indexes (PPD, CAL, and BoP) were improved after each treatment.",['Materials and methods: Thirty-eight patients and 114 teeth were included in this study'],"['hydrogen peroxide (H 2 O 2 ) with diode laser (λ\u2009=\u2009940\u2009nm) in combination with conventional nonsurgical periodontal therapy', 'Group 1 (control group): scaling and root planning (SRP', 'Hydrogen Peroxide Photoactivated Decontamination', 'SRP +940\u2009nm diode laser; Group 3: SRP+photoactivation of H 2 O 2 with 940\u2009nm diode laser']","['periodontal indexes (PPD, CAL, and BoP', 'periodontal probing depth (PPD), clinical attachment level (CAL), and bleeding on probing (BoP', 'bacterial reduction of the major periodontal bacteria such as Porphyromonas gingivalis , Tannerella forsythia , Treponema denticola , Prevotella intermedia , Peptostreptococcus micros , Fusobacterium nucleatum , Eubacterium nodatum', 'total bacteria load']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0031092', 'cui_str': 'Periodontal Indexes'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C1882337', 'cui_str': 'Periodontal probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0085478', 'cui_str': 'Porphyromonas gingivalis'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0242938', 'cui_str': 'Prevotella intermedia'}, {'cui': 'C0030967', 'cui_str': 'Peptostreptococcus'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0085479', 'cui_str': 'Fusobacterium nucleatum'}, {'cui': 'C0317496', 'cui_str': 'Eubacterium nodatum'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.024316,"The total bacteria load was reduced for all three studied groups and all periodontal indexes (PPD, CAL, and BoP) were improved after each treatment.","[{'ForeName': 'Alin Alexandru', 'Initials': 'AA', 'LastName': 'Odor', 'Affiliation': 'Department of Periodontology, Faculty of Dental Medicine, University of Titu Maiorescu, Bucharest, Romania.'}, {'ForeName': 'Edwin Sever', 'Initials': 'ES', 'LastName': 'Bechir', 'Affiliation': 'Department of Oral Rehabilitation and Oclusology, Faculty of Dental Medicine, University of Medicine, Pharmacy, Science and Technology of Târgu-Mureş, Târgu-Mureş, Romania.'}, {'ForeName': 'Doriana Agop', 'Initials': 'DA', 'LastName': 'Forna', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine, University of Medicine and Pharmacy Gr.T. Popa Iaşi, Iaşi, Romania.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4718']
2772,32503392,A Pilot Study of a Videoconferencing-Based Binge Eating Disorder Program in Overweight or Obese Females.,"Background: There has been increasing interest in using videoconferencing in health care, but limited research was conducted in Binge Eating Disorder (BED) patients. This 3-month pilot study aimed to assess the feasibility, acceptability, and preliminary efficacy of a videoconferencing (VC)-based treatment program in overweight and obese females with BED. Methods: Eighteen participants, aged 20-73, were diagnosed and randomized into either a face-to-face (F2F) group or a VC-based group. In the F2F group, participants received 12 one-on-one weekly counseling sessions from a Licensed Mental Health Counselor and Registered Dietitian Nutritionist. In the VC group, participants received the same counseling through an online telemedicine software. Measured outcomes include retention, adherence to treatment, and attitudinal and behavioral changes of participants. Results: In the end of study, of the 9 participants randomized into each group, 8 (88.9%) F2F participants and 4 (44.4%) VC participants completed the study. On average, F2F finishers attended 94.8% of sessions and completed 66.2% of dietary diaries. VC finishers attended 95.8% of sessions and completed 55.4% of diaries. No changes in weight and binge eating episode were observed in either group. F2F finishers had significant improvement on uncontrolled eating ( p = 0.01), emotional eating ( p = 0.004), food addiction diagnosis ( p = 0.04), loss of control ( p = 0.04), and clinical significance ( p = 0.04). VC finishers observed significant improvements in eating disorder examination shape concern ( p = 0.03) and global score ( p = 0.03). Conclusion: VC-based treatment program is feasible and could be effective for BED patients. Long-term large-scale randomized clinical trials are warranted to further assess the efficacy.",2020,"F2F finishers had significant improvement on uncontrolled eating ( p = 0.01), emotional eating ( p = 0.004), food addiction diagnosis ( p = 0.04), loss of control ( p = 0.04), and clinical significance ( p = 0.04).","['9 participants randomized into each group, 8 (88.9%) F2F participants and 4 (44.4%) VC participants completed the study', 'overweight and obese females with BED', 'Overweight or Obese Females', 'Binge Eating Disorder (BED) patients', 'Eighteen participants, aged 20-73']","['videoconferencing (VC)-based treatment program', 'Videoconferencing-Based Binge Eating Disorder Program', 'same counseling through an online telemedicine software', 'face-to-face (F2F) group or a VC-based group']","['uncontrolled eating', 'loss of control', 'retention, adherence to treatment, and attitudinal and behavioral changes of participants', 'emotional eating', 'eating disorder examination shape concern', 'global score', 'food addiction diagnosis', 'weight and binge eating episode']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",9.0,0.0653382,"F2F finishers had significant improvement on uncontrolled eating ( p = 0.01), emotional eating ( p = 0.004), food addiction diagnosis ( p = 0.04), loss of control ( p = 0.04), and clinical significance ( p = 0.04).","[{'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Nutrition and Dietetics, University of North Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Brittnee', 'Initials': 'B', 'LastName': 'Roberts', 'Affiliation': 'Department of Nutrition and Dietetics, University of North Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Snyder', 'Affiliation': 'Department of Nutrition and Dietetics, University of North Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Stuart', 'Affiliation': 'Katie Stuart Coaching and Counseling, Jacksonville Beach, Florida, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilburn', 'Affiliation': 'Jen Wilburn Coaching and Counseling, Neptune Beach, Florida, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Pudwill', 'Affiliation': 'Balanced Nutrition of Jacksonville, Jacksonville, Florida, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Cortazzo', 'Affiliation': 'Department of Nutrition and Dietetics, University of North Florida, Jacksonville, Florida, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0070']
2773,32503395,Effects of Collaborative Care for Comorbid Attention Deficit Hyperactivity Disorder Among Children With Behavior Problems in Pediatric Primary Care.,"This study evaluates the impact of a 6-month care management intervention for 206 children diagnosed with comorbid attention deficit hyperactivity disorder (ADHD) from a sample of 321 five- to 12-year-old children recruited for treatment of behavior problems in 8 pediatric primary care offices. Practices were cluster-randomized to Doctor Office Collaboration Care (DOCC) or Enhanced Usual Care (EUC). Chart reviews documented higher rates of service delivery, prescription of medication for ADHD, and titration in DOCC (vs EUC). Based on complex conditional models, DOCC showed greater acute improvement in individualized ADHD treatment goals and follow-up improvements in quality of life and ADHD and oppositional defiant disorder goals. Medication use had a significant effect on acute and follow-up ADHD symptom reduction and quality of life. Medication continuity was associated with some long-term gains. A collaborative care intervention for behavior problems that incorporated treatment guidelines for ADHD in primary care was more effective than psychoeducation and facilitated referral to community treatment.",2020,A collaborative care intervention for behavior problems that incorporated treatment guidelines for ADHD in primary care was more effective than psychoeducation and facilitated referral to community treatment.,"['Children', 'Comorbid Attention Deficit Hyperactivity Disorder', '206 children diagnosed with comorbid attention deficit hyperactivity disorder (ADHD) from a sample of 321 five- to 12-year-old children recruited for treatment of behavior problems in 8 pediatric primary care offices']","['Collaborative Care', 'care management intervention', 'Doctor Office Collaboration Care (DOCC) or Enhanced Usual Care (EUC']","['quality of life and ADHD and oppositional defiant disorder goals', 'acute and follow-up ADHD symptom reduction and quality of life', 'Medication continuity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031834', 'cui_str': ""Physician's Office""}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}]",206.0,0.0862828,A collaborative care intervention for behavior problems that incorporated treatment guidelines for ADHD in primary care was more effective than psychoeducation and facilitated referral to community treatment.,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kolko', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Hart', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campo', 'Affiliation': 'Ohio State University, Morgantown, WV, USA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rounds', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Wolraich', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",Clinical pediatrics,['10.1177/0009922820920013']
2774,32503465,Feasibility and safety of high-intensity interval training for the rehabilitation of geriatric inpatients (HIITERGY) a pilot randomized study.,"BACKGROUND
High-intensity interval training (HIIT) has been shown to be more effective than moderate-intensity continuous training (MICT) for the physical rehabilitation. However, data on its suitability for older hospitalized patients is scarce.
METHODS
Randomized controlled trial in a hospital setting. Inclusion of 100 patients, ≥65 years old, hospitalized for rehabilitation after an acute medical condition, in a two-week rehabilitation program of either four HIIT or three MICT sessions per week. Completion was defined as participation in all but two planned sessions accomplishing ≥50% of each session. We assessed: upper-limb muscle strength (handgrip isometric strength test), lower-limb muscle strength (quadriceps and ankle flexion and extension tests); gait speed and spatio-temporal parameters (instrumented walkway), and exercise capacity (6-min walk test). All adverse events were recorded as safety endpoints.
RESULTS
An intention-to-treat analysis showed a 44% completion rate for the HIIT group (95% CI, 30-59) and 77% for MICT (95% CI, 55-82). A modified intention-to-treat analysis restricted to patients who participated in ≥1 session showed an 88% completion rate in the HIIT group (95%CI, 69-97) and an 80% completion rate in MICT (95%CI, 65-90). The exercises most frequently undertaken were the pedal exerciser (54%) and the NuStep (32%). There were no significant differences in the various measures. No serious adverse events occurred.
CONCLUSION
A HIIT rehabilitation program for this population was feasible, safe and had a high adherence rate.
TRIAL REGISTRATION NUMBER
Clinicatrials.gov ID: NCT02318459. Trial registration date: November 7th, 2014. Retrospectively registered. This study adheres to the CONSORT guidelines.",2020,The exercises most frequently undertaken were the pedal exerciser (54%) and the NuStep (32%).,"['100 patients, ≥65\u2009years old, hospitalized for rehabilitation after an acute medical condition, in a two-week rehabilitation program of either four HIIT or three MICT sessions per week', 'geriatric inpatients (HIITERGY', 'older hospitalized patients']","['high-intensity interval training', 'High-intensity interval training (HIIT', 'MICT']","['Feasibility and safety', 'upper-limb muscle strength (handgrip isometric strength test), lower-limb muscle strength (quadriceps and ankle flexion and extension tests); gait speed and spatio-temporal parameters (instrumented walkway), and exercise capacity (6-min walk test']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",,0.141577,The exercises most frequently undertaken were the pedal exerciser (54%) and the NuStep (32%).,"[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Pires Peixoto', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Trombert', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Poncet', 'Affiliation': 'Division of clinical epidemiology, Geneva University Hospitals and Geneva Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Kizlik', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gold', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ehret', 'Affiliation': 'Division of Cardiology, Department of Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Trombetti', 'Affiliation': 'Division of Bone Diseases, Department of Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Reny', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland. jean-luc.reny@hcuge.ch.'}]",BMC geriatrics,['10.1186/s12877-020-01596-7']
2775,32503469,INFORM2 NivEnt: The first trial of the INFORM2 biomarker driven phase I/II trial series: the combination of nivolumab and entinostat in children and adolescents with refractory high-risk malignancies.,"BACKGROUND
Pediatric patients with relapsed or refractory disease represent a population with a desperate medical need. The aim of the INFORM (INdividualized Therapy FOr Relapsed Malignancies in Childhood) program is to translate next generation molecular diagnostics into a biomarker driven treatment strategy. The program consists of two major foundations: the INFORM registry providing a molecular screening platform and the INFORM2 series of biomarker driven phase I/II trials. The INFORM2 NivEnt trial aims to determine the recommended phase 2 dose (RP2D) of the combination treatment of nivolumab and entinostat (phase I) and to evaluate activity and safety (phase II).
METHODS
This is an exploratory non-randomized, open-label, multinational and multicenter seamless phase I/II trial in children and adolescents with relapsed / refractory or progressive high-risk solid tumors and CNS tumors. The phase I is divided in 2 age cohorts: 12-21 years and 6-11 years and follows a 3 + 3 design with two dose levels for entinostat (2 mg/m 2 and 4 mg/m 2 once per week) and fixed dose nivolumab (3 mg/kg every 2 weeks). Patients entering the trial on RP2D can seamlessly enter phase II which consists of a biomarker defined four group basket trial: high mutational load (group A), high PD-L1 mRNA expression (group B), focal MYC(N) amplification (group C), low mutational load and low PD-L1 mRNA expression and no MYC(N) amplification (group D). A Bayesian adaptive design will be used to early stop cohorts that fail to show evidence of activity. The maximum number of patients is 128.
DISCUSSION
This trial intends to exploit the immune enhancing effects of entinostat on nivolumab using an innovative biomarker driven approach in order to maximize the chance of detecting signs of activity. It prevents exposure to unnecessary risks by applying the Bayesian adaptive design for early stopping for futility. The adaptive biomarker driven design provides an innovative approach accelerating drug development and reducing exposure to investigational treatments in these vulnerable children at the same time.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03838042. Registered on 12 February 2019.",2020,"The INFORM2 NivEnt trial aims to determine the recommended phase 2 dose (RP2D) of the combination treatment of nivolumab and entinostat (phase I) and to evaluate activity and safety (phase II).
","['Pediatric patients with relapsed or refractory disease represent a population with a desperate medical need', 'children and adolescents with refractory high-risk malignancies', 'children and adolescents with relapsed / refractory or progressive high-risk solid tumors and CNS tumors', '2 age cohorts: 12-21\u2009years and 6-11\u2009years']","['entinostat (2\u2009mg/m 2 and 4\u2009mg/m 2 once per week) and fixed dose nivolumab', 'nivolumab and entinostat', 'INFORM2', 'high PD-L1 mRNA expression']",['activity and safety (phase II'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0085136', 'cui_str': 'Neoplasm of central nervous system'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2743752', 'cui_str': 'entinostat'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",,0.0548795,"The INFORM2 NivEnt trial aims to determine the recommended phase 2 dose (RP2D) of the combination treatment of nivolumab and entinostat (phase I) and to evaluate activity and safety (phase II).
","[{'ForeName': 'Cornelis M', 'Initials': 'CM', 'LastName': 'van Tilburg', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany. cornelis.vantilburg@kitz-heidelberg.de.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Witt', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Heiss', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'Kristian W', 'Initials': 'KW', 'LastName': 'Pajtler', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Plass', 'Affiliation': 'Division of Cancer Epigenomics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Poschke', 'Affiliation': 'DKTK Immune Monitoring Unit, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Platten', 'Affiliation': 'DKTK Immune Monitoring Unit, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Harting', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sedlaczek', 'Affiliation': 'Radiology Cooperation Uni/DKFZ, Division of Radiology, NCT, Heidelberg, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Freitag', 'Affiliation': 'NCT Trial Center, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meyrath', 'Affiliation': 'Pharmacy Department, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'Pharmacy Department, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Gnana Prakash', 'Initials': 'GP', 'LastName': 'Balasubramanian', 'Affiliation': ""Hopp Children's Cancer Center Heidelberg (KiTZ), Division of Pediatric Neurooncology, German Cancer Research Center (DKFZ) and German Cancer Consortium (DKTK), Heidelberg, Germany.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Jäger', 'Affiliation': ""Hopp Children's Cancer Center Heidelberg (KiTZ), Division of Pediatric Neurooncology, German Cancer Research Center (DKFZ) and German Cancer Consortium (DKTK), Heidelberg, Germany.""}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Pfaff', 'Affiliation': ""Hopp Children's Cancer Center Heidelberg (KiTZ), Department of Pediatric Hematology and Oncology, Heidelberg University Hospital, Heidelberg, Germany.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Jones', 'Affiliation': ""Hopp Children's Cancer Center Heidelberg (KiTZ), Department of Pediatric Hematology and Oncology, Heidelberg University Hospital, Heidelberg, Germany.""}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Milde', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Pfister', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'David T W', 'Initials': 'DTW', 'LastName': 'Jones', 'Affiliation': ""Pediatric Glioma Research Group, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and German Cancer Consortium (DKTK), Heidelberg, Germany.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Kopp-Schneider', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Witt', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}]",BMC cancer,['10.1186/s12885-020-07008-8']
2776,32503473,The effect of physical activity on cognition relative to APOE genotype (PAAD-2): study protocol for a phase II randomized control trial.,"BACKGROUND
By 2050, the prevalence of Alzheimer's disease (AD) in the United States is predicted to reach 13.8 million. Despite worldwide research efforts, a cure for AD has not been identified. Thus, it is critical to identify preventive strategies that can reduce the risk of or delay the onset of AD. Physical activity (PA) has potential in this regard. This randomized clinical trial aims to (a) test the causal relationship between PA and AD-associated cognitive function for persons with a family history of AD (FH+), (b) determine the moderating role of apolipoprotein epsilon 4 (APOE4) carrier status on cognition, and (c) assess cerebral structure, cerebral function, and putative biomarkers as mediators of the effects of PA on cognition.
METHODS
We are recruiting cognitively normal, middle aged (40-65 years) sedentary adults with FH+. Participants are randomly assigned to a 12-month PA intervention for 3 days/week or to a control group maintaining their normal lifestyle. Saliva samples are taken at pre-test to determine APOE genotype. At pre-, mid-, and post-tests, participants complete a series of cognitive tests to assess information-processing speed, verbal and visual episodic memory, constructional praxis, mnemonic discrimination, and higher-order executive functions. At pre- and post-tests, brain imaging and blood biomarkers are assessed.
DISCUSSION
We hypothesize that 1) the PA group will demonstrate improved cognition compared with controls; 2) PA-derived cognitive changes will be moderated by APOE4 status; and 3) PA-induced changes in neural and blood biomarkers will contribute to cognitive changes and differ as a function of APOE4 status. Our results may provide important insights into the potential of PA to preserve neurocognitive function in people with a heightened risk of AD due to FH+ and as moderated by APOE4 status. By using sophisticated analytic techniques to assess APOE as a moderator and neurobiological mechanisms as mediators across trajectories of cognitive change in response to PA, we will advance our understanding of the potential of PA in protecting against AD.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03876314. Registered March 15, 2019.",2020,Participants are randomly assigned to a 12-month PA intervention for 3 days/week or to a control group maintaining their normal lifestyle.,"['persons with a family history of AD (FH', 'cognitively normal, middle aged (40-65\u2009years) sedentary adults with FH']","['control group maintaining their normal lifestyle', 'PA intervention', 'physical activity', 'PA and AD-associated cognitive function']","['Physical activity (PA', 'information-processing speed, verbal and visual episodic memory, constructional praxis, mnemonic discrimination, and higher-order executive functions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1271045', 'cui_str': ""FH: Alzheimer's disease""}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0760556,Participants are randomly assigned to a 12-month PA intervention for 3 days/week or to a control group maintaining their normal lifestyle.,"[{'ForeName': 'Kyoung Shin', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Ganesh', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Nathaniel T', 'Initials': 'NT', 'LastName': 'Berry', 'Affiliation': 'Under Armour, Baltimore, MD, 21209, USA.'}, {'ForeName': 'Yashonda P', 'Initials': 'YP', 'LastName': 'Mobley', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Karper', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Labban', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Wahlheim', 'Affiliation': 'Department of Psychology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Tomika M', 'Initials': 'TM', 'LastName': 'Williams', 'Affiliation': 'Department of Advanced Nursing Practice and Education, East Carolina University, Greenville, NC, 27858, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Wideman', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA. jletnier@uncg.edu.'}]",BMC neurology,['10.1186/s12883-020-01732-1']
2777,32503494,Effects of trimetazidine on ventricular remodeling in coronary artery disease patients with left ventricular hypertrophy: the rationale and design of a randomized controlled trial.,"BACKGROUND
Trimetazidine is a metabolic anti-ischemic agent, which increases the tolerance of cardiomyocytes to ischemia. However, few studies have explored the effect of trimetazidine on ventricular remodeling in coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) with left ventricular hypertrophy (LVH).
METHODS
It is a randomized, placebo-controlled trial, and we propose to recruit one hundred and twenty-four CAD patients undergoing PCI with LVH during a 12-month period. They will be randomized to receive either trimetazidine (35 mg twice a day) or placebo in the following 12 months after PCI. Blood tests, echocardiography, symptom of angina and major adverse cardiovascular events (MACEs) will be collected at follow-up visit at 3 and 12 months. The primary end point will be the left ventricular remodeling measured by left ventricular mass index (LVMI) at 3- and 12-month follow-up compared with the baseline. The secondary end points will be the symptom of angina assessed by Seattle Angina Questionnaire, myocardial ischemia measured by 6-min walk test and exercise electrocardiography test, as well as MACEs (defined as a composite of death, myocardial infarction, stroke, recurrent angina, re-hospitalization, change of viable myocardium).
DISCUSSION
This study aims to demonstrate the effect of trimetazidine on left ventricular remodeling and myocardial ischemia in CAD patients undergoing PCI with LVH. Trimetazidine treatment is likely to improve the left ventricular remodeling, symptoms of angina and myocardial ischemia. It might also reduce the risk of MACEs in CAD patients undergoing PCI with LVH.
TRIAL REGISTRATION
http://www.chictr.org.cn, Chinese Clinical Trial Registry (ChiCTR1800017876). Registered on 19 Aug 2018.",2020,They will be randomized to receive either trimetazidine (35 mg twice a day) or placebo in the following 12 months after PCI.,"['coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) with left ventricular hypertrophy (LVH', 'coronary artery disease patients with left ventricular hypertrophy', 'recruit one hundred and twenty-four CAD patients undergoing PCI with LVH during a 12-month period', 'CAD patients undergoing PCI with LVH']","['Trimetazidine', 'trimetazidine', 'placebo']","['left ventricular remodeling, symptoms of angina and myocardial ischemia', 'left ventricular remodeling measured by left ventricular mass index (LVMI', 'Blood tests, echocardiography, symptom of angina and major adverse cardiovascular events (MACEs', 'left ventricular remodeling and myocardial ischemia', 'ventricular remodeling', 'symptom of angina assessed by Seattle Angina Questionnaire, myocardial ischemia measured by 6-min walk test and exercise electrocardiography test, as well as MACEs (defined as a composite of death, myocardial infarction, stroke, recurrent angina, re-hospitalization, change of viable myocardium', 'risk of MACEs']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.187267,They will be randomized to receive either trimetazidine (35 mg twice a day) or placebo in the following 12 months after PCI.,"[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luan', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Chongying', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China. 3313011@zju.edu.cn.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01557-3']
2778,32503502,"Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a multicenter, placebo controlled, double blind, randomized clinical trial.","BACKGROUND
Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks.
METHODS
A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 - none; 3 - global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events.
RESULTS
The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups.
CONCLUSIONS
Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation.
TRIAL REGISTRATION
This trial was registered at www.clinicaltrials.gov under the name ""Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent"" with date 2nd November 2017, code NCT03343275, and URL.",2020,Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91,['105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain'],['placebo'],"['Mean encrustation score', 'urine pH decrease, stent removal, and incidence of adverse events', 'global encrustation rate of stent ends', 'efficacy and safety', 'urine pH decreases', 'degree of stent ends encrustation, defined by a 4-point score (0 - none; 3 - global encrustation) using macroscopic and electron microscopy analysis of crystals', 'incidence of adverse events']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0854059', 'cui_str': 'pH urine decreased'}, {'cui': 'C0522778', 'cui_str': 'Removal of stent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",105.0,0.781105,Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Torrecilla', 'Affiliation': 'Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Fernández-Concha', 'Affiliation': 'Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Cansino', 'Affiliation': 'La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Mainez', 'Affiliation': 'La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'José H', 'Initials': 'JH', 'LastName': 'Amón', 'Affiliation': 'Rio Hortega University Hospital, Valladolid, Spain.'}, {'ForeName': 'Simbad', 'Initials': 'S', 'LastName': 'Costas', 'Affiliation': 'Mateu Orfila Hospital, Maó, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Angerri', 'Affiliation': 'Puigvert Foundation, Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Emiliani', 'Affiliation': 'Puigvert Foundation, Barcelona, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Arrabal Martín', 'Affiliation': 'San Cecilio University Hospital, Granada, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Arrabal Polo', 'Affiliation': 'San Cecilio University Hospital, Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García', 'Affiliation': 'Virgen de Valme University Hospital, Sevilla, Spain.'}, {'ForeName': 'Manuel C', 'Initials': 'MC', 'LastName': 'Reina', 'Affiliation': 'Virgen de Valme University Hospital, Sevilla, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Sánchez', 'Affiliation': 'Álvaro Cunqueiro Hospital, Vigo, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Budía', 'Affiliation': 'University and Polytechnic La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pérez-Fentes', 'Affiliation': 'University Hospital Complex of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Grases', 'Affiliation': 'Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS- IDISBA), University of Balearic Islands (UIB), Palma de Mallorca, Spain. fgrases@uib.es.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Costa-Bauzá', 'Affiliation': 'Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS- IDISBA), University of Balearic Islands (UIB), Palma de Mallorca, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cuñé', 'Affiliation': 'Devicare S.L., Cerdanyola del Vallès, Spain.'}]",BMC urology,['10.1186/s12894-020-00633-2']
2779,32503515,"Comparison of ceftriaxone plus macrolide and ampicillin/sulbactam plus macrolide in treatment for patients with community-acquired pneumonia without risk factors for aspiration: an open-label, quasi-randomized, controlled trial.","BACKGROUND
Ceftriaxone (CTRX) and ampicillin/sulbactam (ABPC/SBT) are recommended by various guidelines as the first-line antibiotics for community-acquired pneumonia (CAP). However, which of these antibiotics is more effective for treating non-aspiration CAP remains unclear.
METHODS
This study was a prospective, single-center, open-label, quasi-randomized controlled trial. Patients with adult CAP without risk for aspiration were allocated to either a CTRX or ABPC/SBT group based on the date of hospital admission. Macrolide was added to patients in each group. The primary outcome was the clinical response in the validated per-protocol (VPP) population at end of treatment (EOT). The secondary outcomes were clinical response during treatment and at end of study (EOS) in the VPP population, and mortality rate at day 30 in the modified intention-to-treat (MITT) population.
RESULTS
Of 696 screened patients, 433 patients were excluded and 263 patients were allocated to receive either of the treatments. Males comprised 54% of patients and mean age and PSI were 62.1 ± 19.8 years and 69.3 ± 30.0, respectively, with 124 patients allocated to the CTRX group and 138 patients allocated to the ABPC/SBT group. The clinical effectiveness rate for the VPP population at EOT was 90% in the CTRX and 96% in the ABPC/SBT group (p = 0.072, 95% confidence interval [CI] of risk difference [RD]: - 12.6-0.8%). No significant difference in effectiveness at day 4 was observed between the CTRX and ABPC/SBT groups (p = 0.079, 95%CI of RD: - 12.1-0.4%), but at day 7, ABPC/SBT was significantly more effective than CTRX in the VPP population (p = 0.047, 95%CI of RD: - 13.3--0.4%). No significant difference in late response at EOS was seen between CTRX and ABPC/SBT groups: cure (89 [86%] and 102 [94%]), relapse (5 [5%] and 1 [1%]) and failure (10 [10%] and 5 [5%]; p = 0.053). Deaths within 30 days in MITT population was higher in CTRX group (4 [3%]) than in ABPC/SBT group (0 [0%]) (p = 0.048, 95%CI of RD: 0.1-6.3%).
CONCLUSION
No significant difference in effectiveness was found between ABPC/SBT and CTRX at EOT. However, ABPC/SBT might be more effective in the early phase of treatment.
TRIAL REGISTRATION
UMIN-CTR, UMIN000037464. Registered 25 July 2019 - Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042262.",2020,"No significant difference in late response at EOS was seen between CTRX and ABPC/SBT groups: cure (89 [86%] and 102 [94%]), relapse (5 [5%] and 1 [1%]) and failure (10 [10%] and 5 [5%]; p = 0.053).","['696 screened patients, 433 patients were excluded and 263 patients', 'Males comprised 54% of patients and mean age and PSI were 62.1\u2009±\u200919.8\u2009years and 69.3\u2009±\u200930.0, respectively, with 124 patients allocated to the CTRX group and 138 patients allocated to the', 'patients with community-acquired pneumonia without risk factors for aspiration', 'Patients with adult CAP without risk for aspiration']","['CTRX or ABPC/SBT', 'Ceftriaxone (CTRX) and ampicillin/sulbactam (ABPC/SBT', 'Macrolide', 'ABPC/SBT', 'CTRX', 'ceftriaxone plus macrolide and ampicillin/sulbactam plus macrolide']","['clinical response during treatment and at end of study (EOS) in the VPP population, and mortality rate', 'failure', 'late response at EOS', 'clinical effectiveness rate', 'clinical response in the validated per-protocol (VPP) population at end of treatment (EOT', 'Deaths', 'relapse']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439472', 'cui_str': 'lb/sq. in'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150012', 'cui_str': 'At risk for aspiration'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0036782', 'cui_str': 'Serum bactericidal titer test'}, {'cui': 'C2930041', 'cui_str': 'sultamicillin'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",433.0,0.115557,"No significant difference in late response at EOS was seen between CTRX and ABPC/SBT groups: cure (89 [86%] and 102 [94%]), relapse (5 [5%] and 1 [1%]) and failure (10 [10%] and 5 [5%]; p = 0.053).","[{'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Hamao', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Ito', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan. isaoito@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Konishi', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Tanabe', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shirata', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Oi', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Tsukino', 'Affiliation': 'Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo, 675-1332, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Yasutomo', 'Affiliation': 'Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo, 675-1332, Japan.'}, {'ForeName': 'Seizo', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo, 675-1332, Japan.'}, {'ForeName': 'Toyohiro', 'Initials': 'T', 'LastName': 'Hirai', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01198-4']
2780,32503517,Online yoga to reduce post traumatic stress in women who have experienced stillbirth: a randomized control feasibility trial.,"BACKGROUND
About 1 in every 150 pregnancies end in stillbirth. Consequences include symptoms of post traumatic stress disorder (PTSD), depression, and anxiety. Yoga has been used to treat PTSD in other populations and may improve health outcomes for stillbirth mothers. The purpose of this study was to determine: (a) feasibility of a 12-week home-based, online yoga intervention with varying doses; (b) acceptability of a ""stretch and tone"" control group; and (c) preliminary efficacy of the intervention on reducing symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health.
METHODS
Participants (N = 90) were recruited nationally and randomized into one of three groups for yoga or exercise (low dose (LD), 60 min per week; moderate dose (MD), 150 min per week; and stretch-and-tone control group (STC)). Baseline and post-intervention surveys measured main outcomes (listed above). Frequency analyses were used to determine feasibility. Repeated measures ANCOVA were used to determine preliminary efficacy. Multiple regression analyses were used to determine a dose-response relationship between minutes of yoga and each outcome variable.
RESULTS
Over half of participants completed the intervention (n = 48/90). Benchmarks (≥70% reported > 75% satisfaction) were met in each group for satisfaction and enjoyment. Participants meeting benchmarks (completing > 90% of prescribed minutes 9/12 weeks) for LD and MD groups were 44% (n = 8/18) and 6% (n = 1/16), respectively. LD and MD groups averaged 44.0 and 77.3 min per week of yoga, respectively. The MD group reported that 150 prescribed minutes per week of yoga was too much. There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups. There was a significant difference in depression scores (p = .036) and grief intensity (p = .009) between the MD and STC groups. PTSD showed non-significant decreases of 43% and 56% at post-intervention in LD and MD groups, respectively (22% decrease in control).
CONCLUSIONS
This was the first study to determine the feasibility and preliminary efficacy of an online yoga intervention for women after stillbirth. Future research warrants a randomized controlled trial.
TRIAL REGISTRATION
ClinicalTrials.gov. NCT02925481. Registered 10-04-16.",2020,"There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups.","['women after stillbirth', 'women who have experienced stillbirth', 'Participants (N\xa0=\u200990', 'stillbirth mothers']","['online yoga intervention', 'stretch and tone"" control', 'Online yoga', 'yoga or exercise (low dose (LD), 60\u2009min per week; moderate dose (MD), 150\u2009min per week; and stretch-and-tone control group (STC']","['depression scores', 'symptoms of post traumatic stress disorder (PTSD), depression, and anxiety', 'symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health', 'grief intensity', 'PTSD and depression, and improvements in self-rated health']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.104793,"There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': 'Arizona State University, Tempe, USA. Jhuberty@asu.edu.'}, {'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jeni', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kurka', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jenn', 'Initials': 'J', 'LastName': 'Leiferman', 'Affiliation': 'Colorado School of Public Health, Denver, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gold', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cacciatore', 'Affiliation': 'Arizona State University, Tempe, USA.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02926-3']
2781,32503545,Post-hospital medical respite care for homeless people in Denmark: a randomized controlled trial and cost-utility analysis.,,2020,,['homeless people in Denmark'],[],[],"[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]",[],[],,0.129307,,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Bring', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark. camillabring@hotmail.com.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kruse', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Mikkel Z', 'Initials': 'MZ', 'LastName': 'Ankarfeldt', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Brünés', 'Affiliation': 'Patient Care, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}]",BMC health services research,['10.1186/s12913-020-05358-4']
2782,32503556,"Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan.","BACKGROUND
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. In Afghanistan, where most births take place at home without the assistance of a skilled birth attendant, there is a need for options to manage PPH in community-based settings. Misoprostol, a uterotonic that has been used as prophylaxis at the household level and has also been proven to be effective in treating PPH in hospital settings, is one possible option.
METHODS
A double-blind, randomized placebo-controlled trial was conducted in six districts in Badakhshan Province, Afghanistan to test the effectiveness and safety of administering 800mcg sublingual misoprostol to women after a home birth for treatment of excessive blood loss. Consenting women were enrolled prior to delivery and given 600mcg misoprostol to self-administer orally as prophylaxis. Community health workers (CHW) were trained to observe for signs of PPH after delivery and if PPH was diagnosed, administer the study medication (misoprostol or placebo) and immediately refer the woman. A hemoglobin (Hb) decline of 2 g/dL or greater, measured pre- and post-delivery, served as the primary outcome; side effects, additional interventions, and transfer rates were also analyzed.
RESULTS
Among the 1884 women who delivered at home, nearly all (98.7%) reported self-use of misoprostol for PPH prevention. A small fraction was diagnosed with PPH (4.4%, 82/1884) and was administered treatment. Hb outcomes, including the proportion of women with a Hb drop of 2 g/dL or greater, were similar between the study groups (misoprostol: 56.4% (22/39), placebo: 60.6% (20/33), p = 0.45). Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03). Other side effects were similar between study groups and none required treatment, including among the subset of 39 women, who received misoprostol for both of its PPH indications.
CONCLUSIONS
While the study did not document a clinical benefit associated with misoprostol for treatment of PPH, study findings suggest that use of misoprostol for both prevention and treatment in the same birth as well as its use by lay level providers in home births does not result in any safety concerns.
TRIAL REGISTRATION
This trial was registered with ClinicalTrials.gov, number NCT01508429 Registered on December 1, 2011.",2020,"Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03).","['Badakhshan province, Afghanistan', 'postpartum hemorrhage', 'to women after a home birth for treatment of excessive blood loss', 'Community health workers (CHW', 'Consenting women were enrolled prior to delivery and given 600mcg', 'six districts in Badakhshan Province, Afghanistan', '1884 women who delivered at home, nearly all (98.7%) reported self-use of']","['medication (misoprostol or placebo', 'Misoprostol', 'misoprostol to self-administer orally as prophylaxis', 'sublingual misoprostol', 'misoprostol', 'placebo']","['proportion of women with a Hb drop of 2\u2009g/dL', 'side effects, additional interventions, and transfer rates', 'A hemoglobin (Hb) decline', 'shivering']","[{'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019857', 'cui_str': 'Home birth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}]",,0.667159,"Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03).","[{'ForeName': 'Dina F', 'Initials': 'DF', 'LastName': 'Abbas', 'Affiliation': 'Gynuity Health Projects, 220 East 42nd Street Suite 710, New York, NY, 10017, USA.'}, {'ForeName': 'Shafiq', 'Initials': 'S', 'LastName': 'Mirzazada', 'Affiliation': 'Academic Projects Afghanistan, Aga Khan University, Co French Medical Institute for Children, Ali Abad, Kabul, Afghanistan.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Durocher', 'Affiliation': 'Gynuity Health Projects, 220 East 42nd Street Suite 710, New York, NY, 10017, USA. jdurocher@gynuity.org.'}, {'ForeName': 'Shahfaqir', 'Initials': 'S', 'LastName': 'Pamiri', 'Affiliation': 'Aga Khan Health Services Afghanistan (AKHS-A), An Agency of the Aga Khan Development Network (AKDN), Baghlan, Afghanistan.'}, {'ForeName': 'Meagan E', 'Initials': 'ME', 'LastName': 'Byrne', 'Affiliation': 'Gynuity Health Projects, 220 East 42nd Street Suite 710, New York, NY, 10017, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Winikoff', 'Affiliation': 'Gynuity Health Projects, 220 East 42nd Street Suite 710, New York, NY, 10017, USA.'}]",Reproductive health,['10.1186/s12978-020-00933-8']
2783,32503599,Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial.,"BACKGROUND
This analysis of the IMPACT study assessed the cardiovascular (CV) safety of single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy.
METHODS
IMPACT was a 52-week, randomized, double-blind, multicenter Phase III study comparing the efficacy and safety of FF/UMEC/VI 100/62.5/25 mcg with FF/VI 100/25 mcg or UMEC/VI 62.5/25 mcg in patients ≥40 years of age with symptomatic chronic obstructive pulmonary disease (COPD) and ≥1 moderate/severe exacerbation in the previous year. The inclusion criteria for the study were intentionally designed to permit the enrollment of patients with significant concurrent CV disease/risk. CV safety assessments included proportion of patients with and exposure-adjusted rates of on-treatment CV adverse events of special interest (CVAESI) and major adverse cardiac events (MACE), as well as time-to-first (TTF) CVAESI, and TTF CVAESI resulting in hospitalization/prolonged hospitalization or death.
RESULTS
Baseline CV risk factors were similar across treatment groups. Overall, 68% of patients (n = 7012) had ≥1 CV risk factor and 40% (n = 4127) had ≥2. At baseline, 29% of patients reported a current/past cardiac disorder and 58% reported a current/past vascular disorder. The proportion of patients with on-treatment CVAESI was 11% for both FF/UMEC/VI and UMEC/VI, and 10% for FF/VI. There was no statistical difference for FF/UMEC/VI versus FF/VI or UMEC/VI in TTF CVAESI (hazard ratio [HR]: 0.98, 95% confidence interval [CI]: 0.85, 1.11; p = 0.711 and HR: 0.92, 95% CI: 0.78, 1.08; p = 0.317, respectively) nor TTF CVAESI leading to hospitalization/prolonged hospitalization or death (HR: 1.19, 95% CI: 0.93, 1.51; p = 0.167 and HR: 0.96, 95% CI: 0.72, 1.27; p = 0.760, respectively). On-treatment MACE occurred in ≤3% of patients across treatment groups, with similar prevalence and rates between treatments.
CONCLUSIONS
In a symptomatic COPD population with a history of exacerbations and a high rate of CV disease/risk, the proportion of patients with CVAESI and MACE was 10-11% and 1-3%, respectively, across treatment arms, and the risk of CVAESI was low and similar across treatment arms. There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI.
TRIAL REGISTRATION
NCT02164513 (GSK study number CTT116855).",2020,"There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI.
","['patients with COPD', 'patients ≥40\u2009years of age with symptomatic chronic obstructive pulmonary disease (COPD) and\u2009≥1 moderate/severe exacerbation in the previous year']","['Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol', 'FF/UMEC/VI 100/62.5/25 mcg with FF/VI 100/25 mcg or UMEC', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy']","['cardiovascular (CV) safety', 'CV risk', 'efficacy and safety', 'CV safety assessments included proportion of patients with and exposure-adjusted rates of on-treatment CV adverse events of special interest (CVAESI) and major adverse cardiac events (MACE), as well as time-to-first (TTF) CVAESI, and TTF CVAESI resulting in hospitalization/prolonged hospitalization or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.678148,"There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI.
","[{'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Day', 'Affiliation': 'GlaxoSmithKline, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK. nicola.x.day@gsk.com.'}, {'ForeName': 'Subramanya', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'GlaxoSmithKline, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, Exeter, UK.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}]",Respiratory research,['10.1186/s12931-020-01398-w']
2784,32503602,Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials.,"OBJECTIVES
The objectives of these two separate trials are: (1) to reduce health care workers (HCWs) absenteeism; and (2) to reduce hospital admission among the elderly during the COVID-19 pandemic through BCG vaccination.
TRIAL DESIGN
Two separate multi-centre placebo-controlled parallel group randomized trials PARTICIPANTS: (1) Health care personnel working in the hospital or ambulance service where they will take care of patients with the COVID-19 infection and (2) elderly ≥60 years. The HCW trial is being undertaken in 9 hospitals. The elderly trial is being undertaken in locations in the community in Nijmegen, Utrecht, and Veghel, in the Netherlands, using senior citizen organisations to facilitate recruitment.
INTERVENTION AND COMPARATOR
For both trials the intervention group will be randomized to vaccination with 0.1 ml of the licensed BCG vaccine (Danish strain 1331, SSI, Denmark, equivalent to 0.075 mg attenuated M. bovis). The placebo group consists of 0.1 ml 0.9% NaCl, which is the same amount, and has the same colour and appearance as the suspended BCG vaccine.
MAIN OUTCOMES
(1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19.
RANDOMISATION
Participants will be randomized to BCG vaccine or placebo (1;1) centrally using a computer- based system, stratified by study centre.
BLINDING (MASKING)
Subjects, investigators, physicians and outcome assessors are blinded for the intervention. Only the pharmacist assistant that prepares- and research personnel that administers- study medicines are unblinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): (1) The sample size for the first trial is N=1500 HCWs randomised 1:1 to either BCG vaccine (n=750) and placebo (n=750) and (2) The sample size for the second trial is N=1600 elderly persons randomised to BCG vaccine (n=800) and the placebo group (n=800).
TRIAL STATUS
HCW: version 4.0, 24-04-2020. Recruitment began 25-03-2020 and was completed on the 23-04-2020. Elderly: version 3.0, 04-04-2020. Recruitment began 16-04- 2020 and is ongoing.
TRIAL REGISTRATION
The HCWs trial was registered 31-03-2020 at clinicaltrials.gov (identifier: NCT04328441) and registered 20-03-2020 at the Dutch Trial Registry (trialregister.nl, identifier Trial NL8477). The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547.
FULL PROTOCOL
The full protocols will be attached as additional files, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"MAIN OUTCOMES
(1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19.
","['N=1600 elderly persons randomised to', 'The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547', 'Recruitment began 25-03-2020 and was completed on the 23-04-2020', 'patients with the COVID-19 infection and (2) elderly ≥60 years', 'HCW: version 4.0, 24-04-2020', 'health care workers and hospital admission by elderly persons during the COVID-19 pandemic']","['Bacillus Calmette-Guérin Vaccination', 'BCG vaccine', 'BCG vaccine or placebo', 'placebo']","['cumulative incidence of hospital admission', '1) Number of days of unplanned work absenteeism in HCWs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",,0.395304,"MAIN OUTCOMES
(1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19.
","[{'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Ten Doesschate', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands. t.tendoesschate@umcutrecht.nl.'}, {'ForeName': 'Simone J C F M', 'Initials': 'SJCFM', 'LastName': 'Moorlag', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'van der Vaart', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Taks', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Debisarun', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Ten Oever', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Chantal P', 'Initials': 'CP', 'LastName': 'Bleeker-Rovers', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Patricia Bruijning', 'Initials': 'PB', 'LastName': 'Verhagen', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Arief', 'Initials': 'A', 'LastName': 'Lalmohamed', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Ter Heine', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'van de Wijgert', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Axel B', 'Initials': 'AB', 'LastName': 'Janssen', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Bonten', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'van Werkhoven', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04389-w']
2785,32503606,Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics.,"BACKGROUND
Around 30% of post-menopausal breast cancer is related to excess body fat, alcohol intake and low levels of physical activity. Current estimates suggest that there is a 12% increased risk in post-menopausal breast cancer for every 5 kg/m 2 increase in body mass index (BMI). Despite this evidence there are few lifestyle programmes directed towards breast cancer risk reduction. This paper describes the process of optimising of the ActWELL programme which aims to support weight management in women invited to attend routine National Health Service (NHS) breast screening clinics.
METHODS
A feasibility study of a prototype programme aiming to change lifestyle behaviours was successfully undertaken. The programme used educational approaches and behaviour change techniques delivered by lifestyle coaches using individual face to face meetings and telephone sessions. To optimise the intervention for a definitive randomised controlled trial of weight management, data from the feasibility trial, focus group discussions conducted with the target population, feedback from the trial public advisory group and comments from peer reviewers were obtained. Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group.
RESULTS
The results from the feasibility trial were considered appropriate for moving on to a full trial with 70% of participants finding the programme acceptable. The primary outcomes (weight loss and physical activity) provided an important focus for design input from the target group. The contributions highlighted the need to review programme duration, coach contact time, content and use of behaviour change techniques and communications generally (e.g. science and evidence, non-judgemental approaches and avoiding guilt). In addition, the need for emphasis on support rather than education became apparent. The recommendations from peer reviewers focussed on the magnitude of effort required to achieve the intended weight loss and weight loss maintenance. Implementation science supported the use of the capability/opportunity/motivation (COM-B)model in overall design.
CONCLUSIONS
The optimisation process has facilitated the development and evaluation of a programme that enables the delivery of a promising intervention to achieve weight management in post-menopausal women.
TRIAL REGISTRATION
ISRCTN: ISRCTN11057518. Registered on 21 July 2017. Retrospectively registered.",2020,"Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group.
","['women attending routine NHS breast screening clinics', 'women invited to attend routine National Health Service (NHS) breast screening clinics', 'post-menopausal women']","['lifestyle intervention programme', 'prototype programme']","['weight loss and physical activity', 'body mass index (BMI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0584181,"Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group.
","[{'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK. a.s.anderson@dundee.ac.uk.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Craigie', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gallant', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'McAdam', 'Affiliation': ""Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, St Leonard's Land, Holyrood Road, Edinburgh, EH8 8AQ, UK.""}, {'ForeName': 'E Jane', 'Initials': 'EJ', 'LastName': 'Macaskill', 'Affiliation': 'Department of Breast Surgery, NHS Tayside, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McKell', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, FK9 4LA, Scotland, UK.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': ""Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, St Leonard's Land, Holyrood Road, Edinburgh, EH8 8AQ, UK.""}, {'ForeName': 'Ronan E', 'Initials': 'RE', 'LastName': ""O'Carroll"", 'Affiliation': 'Division of Psychology, School of Natural Sciences, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Stead', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, FK9 4LA, Scotland, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}]",Trials,['10.1186/s13063-020-04405-z']
2786,32503608,"Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial.","INTRODUCTION
Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation that has shown an effect on anti-hepatitis B virus and on slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial. The objective is that the combination of YinQiSanHuang-antiviral decoction with entecavir will reduce the annual incidence of liver fibrosis/cirrhosis to 1%.
METHODS
This is a multicenter, randomized, placebo-controlled, double-blinded trial involving five hospitals. A total of 802 patients are randomly allocated to two groups: the YQSH group (n = 401) or the placebo group (n = 401). The YQSH group receives YQSH with entecavir; the placebo group receives granules of placebo with entecavir. Patients receive treatment for 52 weeks and then are followed up for 52 ± 2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment. Outcomes will be assessed at baseline and after treatment.
DISCUSSION
Combination therapy could become a trend for treatment of CHB, and this trial expects to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB.
TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR1900021521. Registered on 25 February 2019.",2020,"The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment.","['Chronic hepatitis B (CHB', 'hepatitis B cirrhosis', '802 patients', 'chronic hepatitis B']","['YQSH combined with entecavir', 'Antiviral therapy', 'YinQiSanHuang-antiviral decoction (YQSH', 'entecavir', 'YQSH', 'placebo with entecavir', 'traditional Chinese medicine (TCM', 'YinQiSanHuang-antiviral decoction with entecavir', 'YinQiSanHuang-antiviral decoction', 'placebo']","['efficacy and safety', ""hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment"", 'annual incidence of cirrhosis', 'Efficacy and safety']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0919711', 'cui_str': 'Hepatitis B surface antigen negative'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]",5.0,0.721903,"The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment.","[{'ForeName': 'Qing-Juan', 'Initials': 'QJ', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Wen-Liang', 'Initials': 'WL', 'LastName': 'Lv', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China. wenlianglv@126.com.""}, {'ForeName': 'Juan-Mei', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Zhou', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jiu-Chong', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Ruo-Xuan', 'Initials': 'RX', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Si-Tong', 'Initials': 'ST', 'LastName': 'Chen', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Gao-Hui', 'Initials': 'GH', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zheng-Min', 'Initials': 'ZM', 'LastName': 'Cao', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}]",Trials,['10.1186/s13063-020-04395-y']
2787,32503611,Efficacy of Parent-Infant-Psychotherapy with mothers with postpartum mental disorder: study protocol of the randomized controlled trial as part of the SKKIPPI project.,"BACKGROUND
After the birth of a child, many mothers and fathers experience postpartum mental disorders like depression, anxiety, obsessive-compulsive disorder, stress or other illnesses. This endangers the establishment of a secure attachment between the children and their primary caregivers. Early problems in parent-child interaction can have adverse long-term effects on the family and the child's well-being. In order to prevent a transgenerational transmission of mental disorders, it is necessary to evaluate psychotherapeutic interventions that target psychologically burdened parents of infants or toddlers. The aim of this trial is to investigate the efficacy of Parent-Infant-Psychotherapy (PIP) for mothers with postpartum mental disorder and their infants (0-12 months).
METHODS/DESIGN
In this open, randomized controlled intervention trial 180 mother-infant-dyads will be included and randomly allocated to 12 sessions of PIP or care as usual. The interventions take place either in inpatient adult psychiatric departments or in outpatient settings with home visits. The primary outcome is the change in maternal sensitivity assessed by the Sensitivity subscale of the Emotional Availability Scale (EAS) through videotaped dyadic play-interactions after 6 weeks. Secondary outcomes are maternal psychopathology, stress, parental reflective functioning, infant development and attachment after 6 weeks and 12 months. In addition, maternal attachment (AAI) and reflective functioning (AAI) will be analyzed as potential moderators, and resource usage in the German health system as well as associated costs will be evaluated.
DISCUSSION
There is increasing demand for well-controlled studies on psychotherapeutic interventions in the postpartum period that do not only focus on particular risk groups. This randomized controlled trial (RCT) represents one of the first studies to investigate the efficacy of PIP in inpatient psychiatric departments and outpatient care centers in Germany. The results will fill knowledge gaps on the factors contributing to symptom reduction in postpartum mental disorders and improvements in mother-child relationships and help in developing preventive and therapeutic strategies for the fragmented German health care system.
TRIAL REGISTRATION
German Register for Clinical Trials, ID: DRKS00016353.",2020,Early problems in parent-child interaction can have adverse long-term effects on the family and the child's well-being.,"['inpatient psychiatric departments and outpatient care centers in Germany', 'psychologically burdened parents of infants or toddlers', 'mothers with postpartum mental disorder', 'inpatient adult psychiatric departments or in outpatient settings with home visits', '180 mother-infant-dyads', 'mothers with postpartum mental disorder and their infants (0-12\u2009months']","['Parent-Infant-Psychotherapy (PIP', 'Parent-Infant-Psychotherapy', 'PIP']","['Efficacy', 'maternal attachment (AAI) and reflective functioning (AAI', 'maternal psychopathology, stress, parental reflective functioning, infant development and attachment', 'change in maternal sensitivity assessed by the Sensitivity subscale of the Emotional Availability Scale (EAS) through videotaped dyadic play-interactions']","[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3839606', 'cui_str': 'Parent-infant psychotherapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",,0.12825,Early problems in parent-child interaction can have adverse long-term effects on the family and the child's well-being.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mattheß', 'Affiliation': 'International Psychoanalytic University, Stromstr. 3b, 10555, Berlin, Germany. janna.matthess@ipu-berlin.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Eckert', 'Affiliation': 'International Psychoanalytic University, Stromstr. 3b, 10555, Berlin, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Richter', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Diakonissenkrankenhaus Flensburg, Flensburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'International Psychoanalytic University, Stromstr. 3b, 10555, Berlin, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Reinhold', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vienhues', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Diakonissenkrankenhaus Flensburg, Flensburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Berghöfer', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Roll', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Keil', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Schlensog-Schuster', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'von Klitzing', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ludwig-Körner', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Diakonissenkrankenhaus Flensburg, Flensburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kuchinke', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Diakonissenkrankenhaus Flensburg, Flensburg, Germany.'}]",Trials,['10.1186/s13063-020-04443-7']
2788,32503620,Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial.,"OBJECTIVES
Colchicine is a well-known drug, which has been used for years to treat a wide range of rheumatic and inflammatory disorders. It helps break the cycle of inflammation through diverse mechanisms including reducing Intereukin-6, Interleukin-8, Tumour Necrosis Factor-alpha besides controlling oxidative stress pathways which all are important and pathologic components in the clinical course and outcome of patients infected with COVID-19. This study aims to assess the anti-inflammatory effects of colchicine in non-severe hospitalized COVID-19 patients.
TRIAL DESIGN
Prospective, randomized (1:1 ratio), double blind study with parallel group design.
PARTICIPANTS
Hospitalized patients with positive nasopharyngeal swab for COVID-19 infection (RT -PCR) and lung Computed tomography scan involvement compatible with COVID-19 pneumonia. The patients are not severely hypoxic, do not need intubation or invasive oxygenation.
EXCLUSION CRITERIA
known hypersensitivity to colchicine; known hepatic failure; estimated glomerular filtration rate (eGFR)<30 ml/min/1.73m 2 (by the CKD-EPI Creatinine Equation for Glomerular Filtration Rate (GFR) which estimates GFR based on serum creatinine. ; kidney transplant recipients, using Digoxin, QTc >450 msec. Participants will be recruited from inpatients at Labbafinejad Meidcal Center , Tehran, Iran.
INTERVENTION AND COMPARATOR
Eligible enrolled patients will be randomized into two groups. Group A will receive the antiretroviral Lopinavir/Ritonavir (Kaletra) while group B will receive Lopinavir/Ritonavir (Kaletra) + Colchicine 1.5 mg loading then 0.5 mg twice daily orally. All patients in both groups will receive the same amounts of essential minerals, vitamins as antioxidants, and antibiotics. Patients of both groups will be treated under optimal treatment based on the CDC and WHO guidelines and national consensus proposed in Iran including the same dosages of Lopinavir/Ritonavir, antibiotics, trace elements and antioxidants while only in group-B patients Colchicine will be added on top of this protocol.
MAIN OUTCOMES
Primary: Time for clinical improvement and lung CT score changes 14 days after treatment. Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels reduction - Percentage of patients who require supplemental Oxygen - Mean hospital stay length RANDOMISATION: Patients will be allocated to each group (ratio 1:1) by using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm BLINDING (MASKING): This will be a double-blind study in which participants and those assessing the final outcomes will be blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Regarding the pandemic crisis and our center capacity to hospitalize confirmed COVID-19 patients, a total of 80 patients was found to be logical to be randomized into two groups of 40- patients.
TRIAL STATUS
Recruitment is ongoing. Recruitment began on 20/03/2020 and the date by which the recruitment is anticipated to be completed is 30/05/2020.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04360980, registered 24/04/2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels","[' kidney transplant recipients, using Digoxin, QTc >450 msec', 'Hospitalized Patients with Non-Severe Covid-19 Pneumonia', 'Hospitalized patients with positive nasopharyngeal swab for COVID-19 infection (RT -PCR) and lung Computed tomography scan involvement compatible with COVID-19 pneumonia', '80 patients was found to be logical to be randomized into two groups of 40- patients', 'non-severe hospitalized COVID-19 patients', 'Participants will be recruited from inpatients at Labbafinejad Meidcal Center , Tehran, Iran', 'patients who require supplemental Oxygen - Mean hospital stay length RANDOMISATION']","['Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra', 'Colchicine', 'essential minerals, vitamins as antioxidants, and antibiotics', 'colchicine', 'Lopinavir/Ritonavir, antibiotics, trace elements and antioxidants while only in group-B patients Colchicine', 'antiretroviral Lopinavir/Ritonavir (Kaletra) while group B will receive Lopinavir/Ritonavir (Kaletra) + Colchicine']","['glomerular filtration rate', 'Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels', 'clinical improvement and lung CT score changes']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0439223', 'cui_str': 'ms'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0939357', 'cui_str': 'Kaletra'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0202202', 'cui_str': 'Protein measurement'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0412611', 'cui_str': 'CT of lungs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.454787,"Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels","[{'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Dalili', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran. drn.dalili@sbmu.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kashefizadeh', 'Affiliation': 'Department of Pulmonology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Nafar', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Poorrezagholi', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Firouzan', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Samadian', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Samavat', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Ziaie', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Fatemizadeh', 'Affiliation': 'Department of Internal Medicine, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04455-3']
2789,32503649,The effects of mindfulness-based cognitive therapy on risk and protective factors of depressive relapse - a randomized wait-list controlled trial.,"BACKGROUND
The aim of this randomized wait-list controlled trial was to explore the effects of Mindfulness-Based Cognitive Therapy (MBCT) on risk and protective factors for depressive relapse within the domains of cognition, emotion and self-relatedness.
METHODS
Sixty-eight individuals with recurrent depressive disorder were randomized to MBCT or a wait-list control condition (WLC).
RESULTS
Completers of MBCT (N = 26) improved significantly on measures assessing risk and protective factors of recurrent depression compared to WLC (N = 30) on measures of rumination (d = 0.59, p = .015), emotion regulation (d = 0.50, p = .028), emotional reactivity to stress (d = 0.32, p = .048), self-compassion (d = 1.02, p < .001), mindfulness (d = 0.59, p = .010), and depression (d = 0.40, p = .018). In the Intention To Treat sample, findings were attenuated, but there were still significant results on measures of rumination, self-compassion and depression.
CONCLUSIONS
Findings from the present trial contribute to evidence that MBCT can lead to reduction in risk factors of depressive relapse, and strengthening of factors known to be protective of depressive relapse. The largest changes were found in the domain of self-relatedness, in the form of large effects on the participants' ability to be less self-judgmental and more self-compassionate.
TRIAL REGISTRATION
ISRCTN, ISRCTN18001392. Registered 29 June 2018.",2020,"RESULTS
Completers of MBCT (N = 26) improved significantly on measures assessing risk and protective factors of recurrent depression compared to WLC (N = 30) on measures of rumination (d = 0.59, p = .015), emotion regulation (d = 0.50, p = .028), emotional reactivity to stress (d = 0.32, p = .048), self-compassion (d = 1.02, p < .001), mindfulness (d = 0.59, p = .010), and depression (d = 0.40, p = .018).",['Sixty-eight individuals with recurrent depressive disorder'],"['MBCT', 'Mindfulness-Based Cognitive Therapy (MBCT', 'MBCT or a wait-list control\xa0condition (WLC', 'mindfulness-based cognitive therapy']","['emotion regulation', 'measures of rumination', 'rumination, self-compassion and depression', 'emotional reactivity to stress', 'measures assessing risk and protective factors of recurrent depression', 'self-compassion', 'depression']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0349218', 'cui_str': 'Recurrent depressive disorder, unspecified'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}]",68.0,0.0637137,"RESULTS
Completers of MBCT (N = 26) improved significantly on measures assessing risk and protective factors of recurrent depression compared to WLC (N = 30) on measures of rumination (d = 0.59, p = .015), emotion regulation (d = 0.50, p = .028), emotional reactivity to stress (d = 0.32, p = .048), self-compassion (d = 1.02, p < .001), mindfulness (d = 0.59, p = .010), and depression (d = 0.40, p = .018).","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schanche', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway. elisabeth.schanche@uib.no.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Vøllestad', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Endre', 'Initials': 'E', 'LastName': 'Visted', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Julie Lillebostad', 'Initials': 'JL', 'LastName': 'Svendsen', 'Affiliation': 'Kronstad District Psychiatric Centre (DPS), Division of Psychiatry, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Berge', 'Initials': 'B', 'LastName': 'Osnes', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Per Einar', 'Initials': 'PE', 'LastName': 'Binder', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Franer', 'Affiliation': 'Kronstad District Psychiatric Centre (DPS), Division of Psychiatry, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Sørensen', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}]",BMC psychology,['10.1186/s40359-020-00417-1']
2790,32503652,The effects of Anethum graveolens (dill) powder supplementation on clinical and metabolic status in patients with type 2 diabetes.,"BACKGROUND
The objective of this study was to investigate the effects of Anethum graveolens (dill) powder supplementation on glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal symptoms in patients with type 2 diabetes.
MATERIALS AND METHODS
In this study, 42 patients with type 2 diabetes were randomly allocated to intervention and control groups and received either 3 g/day dill powder or placebo (3 capsules/day, 1 g each). Fasting blood sugar, insulin, homeostatic model assessment of insulin resistance, lipid profile, high-sensitivity C-reactive protein, total antioxidant capacity, malondialdehyde and gastrointestinal symptoms were measured in all of the subjects at baseline and postintervention.
RESULTS
The dill powder supplementation significantly decreased the mean serum levels of insulin, homeostatic model assessment of insulin resistance, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde in the intervention group in comparison with the baseline measurements (P < 0.05). Furthermore, the mean serum levels of high-density lipoprotein and total antioxidant capacity were significantly increased in the intervention group in comparison with the baseline measurement (P < 0.05). Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01). The mean changes in insulin, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde were significantly lower in the intervention group than in the control group (P < 0.05). In addition, the mean changes in high-density lipoprotein were significantly higher in the intervention group than in the control group (P < 0.05).
CONCLUSION
Dill powder supplementation can be effective in controlling the glycemic, lipid, stress oxidative and gastrointestinal symptoms in patients with type 2 diabetes.
TRIAL REGISTRATION
Iran Clinical Trials Registry: IRCT20120704010181N12. Registered on 12 May 2018.",2020,Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01).,"['42 patients with type 2 diabetes', 'patients with type 2 diabetes']","['Anethum graveolens (dill) powder supplementation', '3\u2009g/day dill powder or placebo']","['glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal symptoms', 'clinical and metabolic status', 'mean changes in high-density lipoprotein', 'Colonic motility disorder', 'glycemic, lipid, stress oxidative and gastrointestinal symptoms', 'mean serum levels of high-density lipoprotein and total antioxidant capacity', 'Fasting blood sugar, insulin, homeostatic model assessment of insulin resistance, lipid profile, high-sensitivity C-reactive protein, total antioxidant capacity, malondialdehyde and gastrointestinal symptoms', 'mean changes in insulin, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde', 'mean serum levels of insulin, homeostatic model assessment of insulin resistance, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C1260544', 'cui_str': 'Dill'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",42.0,0.0588679,Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Zakerkish', 'Affiliation': 'Health Research Institute, Diabetes Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Borazjani', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi Angali', 'Affiliation': 'Department of Biostatistic, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Amoochi Foroushani', 'Affiliation': 'Health Research Institute, Diabetes Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. golnazamoochi@gmail.com.'}]",Trials,['10.1186/s13063-020-04401-3']
2791,32503654,Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial.,"BACKGROUND
Recent studies have indicated that a ketogenic diet can be used as an adjuvant therapy to enhance sensitivity to chemotherapy and radiotherapy in cancer patients. However, there are no sufficient data and no consistent international treatment guidelines supporting a ketogenic diet as an adjuvant therapy for metastatic breast cancer. Therefore, this trial was designed to observe whether irinotecan with a ketogenic diet can promote sensitivity to chemotherapy and remit target lesions in locally recurrent or metastatic Her-2-negative breast cancer patients.
METHODS/DESIGN
This trial aims to recruit 518 women with locally recurrent or metastatic breast cancer admitted to the Liaoning Cancer Hospital and Institute (Shenyang, China) in northeast China. All patients will be randomly assigned into the combined intervention group (n = 259) or the control group (n = 259), followed by treatment with irinotecan + ketogenic diet or irinotecan + normal diet, respectively. The primary endpoints are sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness. The endpoints will be evaluated at baseline (before drug administration), during treatment, 4 weeks after treatment completion, and every 3months (beginning 2 months after treatment completion).
DISCUSSION
This trial attempts to investigate whether irinotecan treatment with a ketogenic diet for locally recurrent or metastatic breast cancer among women in northeast China can enhance the disease's sensitivity to chemotherapy and reduce target lesions.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ID: ChiCTR1900024597. Registered on 18 July 2019. Protocol Version: 1.1, 24 February 2017.",2020,"The primary endpoints are sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness.","['518 women with locally recurrent or metastatic breast cancer admitted to the Liaoning Cancer Hospital and Institute (Shenyang, China) in northeast China', 'locally recurrent or metastatic Her-2-negative breast cancer patients', 'cancer patients', 'patients with locally recurrent or metastatic Her-2-negative breast cancer', 'locally recurrent or metastatic breast cancer among women in northeast China']","['chemotherapy and radiotherapy', 'ketogenic diet', 'irinotecan + ketogenic diet or irinotecan + normal diet, respectively', 'irinotecan', 'irinotecan with a ketogenic diet']","['sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",518.0,0.103465,"The primary endpoints are sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Ming-Xi', 'Initials': 'MX', 'LastName': 'Jing', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'Jia', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ying', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Xiang-Yu', 'Initials': 'XY', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China. jianong@126.com.'}]",Trials,['10.1186/s13063-020-04429-5']
2792,32503657,"The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES
A variety of possible mechanisms can make the nucleic acid test of patients who meet the discharge conditions positive again, including reinfection, reactivation of the original virus, lack of strict discharge criteria, new infection, and so on. Different reasons will correspond to different prevention and control measures. We will enroll patients who are discharged after treatment, whose nucleic acid test has changed from negative to positive during the screening visit, regardless of the severity of the symptoms, to investigate the mechanism, clinical outcome and therapeutic efficacy with Favipiravir patients with Corona virus Disease 2019. Favipiravir is an anti-viral agent that selectively and potently inhibits the RNA-dependent RNA polymerase, it has been used for treatment of some life-threatening infections such as Ebola virus, Lassa virus and rabies. Its therapeutic efficacy has been proven in these diseases.
TRIAL DESIGN
This is a multi-center, two arm, open label, parallel group, randomized controlled trial.
PARTICIPANTS
Eligibility criteria: Inclusion criteria: 1.Adults 18 to 80 years, male or female.2.After the first diagnosis and treatment of COVID-19, the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs, has been negative for two consecutive times (sampling time interval of at least 24 hours), in accordance with the COVID-19's diagnosis and treatment Plan (7th Edition), discharged.3.During screening visit (follow-up after discharge), The nucleic acid test of COVID-19 is positive in any one of the following samples: sputum, throat swabs, blood, feces or other specimens. Regardless of whether or not they had symptoms and the severity of symptoms.4.Volunteer to participate in the research and sign the Informed Consent Form.
EXCLUSION CRITERIA
1.Allergic to Favipiravjr;2.Pregnant or lactating women3.Uncontrolled diseases of the blood and cardiovascular system, liver or kidney.4.History of mental disorders, drug abuse or dependence;5.Researchers consider it inappropriate for adults to participate;6.Participating in other clinical studies. Loss to Follow up: Cases that do not complete the clinical trial program will be regarded as lost to follow up. Including the withdrawal of patients by themselves (such as poor compliance, etc.), or the withdrawal of patients ordered by the researcher (those who need other drugs which affect the judgment of the curative effect, and those who need to stop taking drugs for severe adverse events) Study setting: The participating hospitals are some of the designated hospitals that have been or may be admitting patients who meet the eligibility criteria, mainly in Hubei, Shenzhen, Anhui and Beijing. Participants will be recruited from these 15 hospitals: Wuhan Pulmonary Hospital, Hubei; Jinyintan Hospital of Wuhan, Hubei; Ezhou Central Hospital, Hubei; The Second People's Hospital of Fuyang, Anhui; The First Affiliated Hospital of USTC, Anhui; Beijing Youan Hospital, Beijing; Capital Medical University Beijing Institute of Hepatology, Beijing; Ezhou Hospital of Traditional Chinese Medicine, Hubei; Zhongnan Hospital of Wuhan University, Hubei; The Fifth Hospital of ShiJiazhuang, Hebei; Jinan Infectious Diseases Hospital, Shandong; Public Health Clinical Center of Chengdu, Sichuan; Wuxi No.5 People's Hospital, Jiangsu; The Third People's Hospital of Shenzhen, Guangdong; The First Affiliated Hospital of Bengfu Medical College, AnHui.
INTERVENTION AND COMPARATOR
Favipiravir group (experimental): Favipiravir 1600mg each dose, twice a day on the 1st day; 600mg each dose, twice a day from the 2nd to the 7th day, Oral administration, the maximum number of days taken will be no more than 14 days plus routine treatment for COVID-19. Regular treatment group (control): Treatments other than Antiviral drugs can be given. Routine treatment for patients with the corona virus will be administered, this includes oxygen therapy, drugs that reduced phlegm and relieve cough, including thymosin, proprietary Chinese medicine, etc. MAIN OUTCOMES: Primary Outcome Measures: Viral nucleic acid test negative [Time Frame: 5 months]: Subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times (sampling time interval of at least 24 hours).
SECONDARY OUTCOME MEASURES
Clinical cure [Time Frame: 5 months]: 1.Body temperature returned to normal for more than 3 days;2.Lung image improved.3.Clinical manifestation improved;4.The viral nucleic acid test of respiratory specimens was negative for two consecutive times (sampling time interval of at least 24 hours).
RANDOMIZATION
The central randomization system (Interactive Web Response Management System), will be used to randomly divide the subjects into the experimental group and the control group according to the ratio of 2:1. In this study, block randomization will be used, in blocks of 6.
BLINDING (MASKING)
This is an open label trial. Trial participants, investigators, care givers, outcome assessors, and date analysts are not blinded to group assignment.
NUMBERS TO BE RANDOMISED
210 patients are expected to be enrolled and allocated according to the ratio of 2 (Favipiravir group, n=140): 1(regular treatment group, n=70).
TRIAL STATUS
Protocol version number 3.0, 10 th April 2020 First Patient, first visit 17 th March 2020; recruitment end date anticipated June 1, 2020.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04333589, April 3, 2020. Registered April 3, 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The central randomization system (Interactive Web Response Management System), will be used to randomly divide the subjects into the experimental group and the control group according to the ratio of 2:1.","['patients with Corona Virus Disease 2019', 'patients with the corona virus', 'Participants will be recruited from these 15 hospitals: Wuhan Pulmonary Hospital, Hubei; Jinyintan Hospital of Wuhan, Hubei; Ezhou Central Hospital, Hubei', 'patients with Corona virus Disease 2019', ""Eligibility criteria: Inclusion criteria: 1.Adults 18 to 80 years, male or female.2.After the first diagnosis and treatment of COVID-19, the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs, has been negative for two consecutive times (sampling time interval of at least 24 hours), in accordance with the COVID-19's diagnosis and treatment Plan (7th Edition), discharged.3.During screening visit (follow-up after discharge"", 'Subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times (sampling time interval of at least 24 hours', '210 patients are expected to be enrolled and allocated according to the ratio of 2 (Favipiravir group, n=140', 'Protocol version number 3.0, 10 th April 2020']","['Favipiravir', 'Regular treatment group (control']","['Clinical cure', 'severe adverse events', 'Viral nucleic acid test negative']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0854545,"The central randomization system (Interactive Web Response Management System), will be used to randomly divide the subjects into the experimental group and the control group according to the ratio of 2:1.","[{'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Guiqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. john131212@126.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. haohong_pufh@bjmu.edu.cn.'}]",Trials,['10.1186/s13063-020-04430-y']
2793,32503661,Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2).,"BACKGROUND
The prevalence of inadequate symptom control among cancer patients is quite high despite the availability of definitive care guidelines and accurate and efficient assessment tools.
METHODS
We will conduct a hybrid type 2 stepped wedge pragmatic cluster randomized clinical trial to evaluate a guideline-informed enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) care model. Teams of clinicians at five hospitals that care for patients with various cancers will be randomly assigned in steps to the E2C2 intervention. The E2C2 intervention will have two levels of care: level 1 will offer low-touch, automated self-management support for patients reporting moderate sleep disturbance, pain, anxiety, depression, and energy deficit symptoms or limitations in physical function (or both). Level 2 will offer nurse-managed collaborative care for patients reporting more intense (severe) symptoms or functional limitations (or both). By surveying and interviewing clinical staff, we will also evaluate whether the use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 technologies improves patient and clinical outcomes. Finally, we will conduct a mixed methods evaluation to identify disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer.
DISCUSSION
The E2C2 intervention offers a pragmatic, scalable approach to delivering guideline-based symptom and function management for cancer patients. Since discrete EHR-imbedded algorithms drive defining aspects of the intervention, the approach can be efficiently disseminated and updated by specifying and modifying these centralized EHR algorithms.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03892967. Registered on 25 March 2019.",2020,"The E2C2 intervention offers a pragmatic, scalable approach to delivering guideline-based symptom and function management for cancer patients.","['elderly and rural-dwelling patients with cancer', 'Teams of clinicians at five hospitals that care for patients with various cancers', 'cancer patients']","['enhanced EHR-facilitated cancer symptom control (E2C2', 'E2C2 intervention']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.151335,"The E2C2 intervention offers a pragmatic, scalable approach to delivering guideline-based symptom and function management for cancer patients.","[{'ForeName': 'Lila J', 'Initials': 'LJ', 'LastName': 'Finney Rutten', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA. rutten.lila@mayo.edu.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Chlan', 'Affiliation': 'Department of Nursing, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Griffin', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jeph', 'Initials': 'J', 'LastName': 'Herrin', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Leppin', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Deirdre R', 'Initials': 'DR', 'LastName': 'Pachman', 'Affiliation': 'Center for Palliative Care, Mayo Clinic, Minnesota, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Ridgeway', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Parvez A', 'Initials': 'PA', 'LastName': 'Rahman', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Curtis B', 'Initials': 'CB', 'LastName': 'Storlie', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Wilson', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Cheville', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}]",Trials,['10.1186/s13063-020-04335-w']
2794,32503662,Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
The hypothesis of the study is that treatment with hydroxychloroquine sulphate in hospitalised patients with coronavirus disease 2019 (Covid-19) is safe and will accelerate the virological clearance rate for patients with moderately severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) when compared to standard care. Furthermore, we hypothesize that early treatment with hydroxychloroquine sulphate is associated with more rapid resolve of clinical symptoms as assessed by the National Early Warning Score 2 (NEWS2), decreased admission rate to intensive care units and mortality, and improvement in protein biomarker profiles (C-reactive protein, markers of renal and hepatic injury, and established cardiac biomarkers like cardiac troponin and B-type natriuretic peptide).
TRIAL DESIGN
The study is a two-arm, open label, pragmatic randomised controlled group sequential adaptive trial designed to assess the effect on viral loads and clinical outcome of hydroxychloroquine sulphate therapy in addition to standard care compared to standard care alone in patients with established Covid-19. By utilizing resources already paid for by the hospitals (physicians and nurses in daily clinical practice), this pragmatic trial can include a larger number of patients over a short period of time and at a lower cost than studies utilizing traditional randomized controlled trial designs with an external study organization. The pragmatic approach will enable swift initiation of randomisation and allocation to treatment.
PARTICIPANTS
Patients will be recruited from all inpatients at Akershus University Hospital, Lørenskog, Norway. Electronic real-time surveillance of laboratory reports from the Department of Microbiology will be examined regularly for SARS-CoV-2 positive subjects. All of the following conditions must apply to the prospective patient at screening prior to inclusion: (1) Hospitalisation; (2) Adults 18 years or older; (3) Moderately severe Covid-19 disease (NEWS2 of 6 or less); (4) SARS-CoV-2 positive nasopharyngeal swab; (5) Expected time of hospitalisation > 48 hours; and (6) Signed informed consent must be obtained and documented according to Good Clinical Practice guidelines of the International Conference on Harmonization, and national/local regulations. Patients will be excluded from participation in the study if they meet any of the following criteria: (1) Requiring intensive care unit admission at screening; (2) History of psoriasis; (3) Known adverse reaction to hydroxychloroquine sulphate; (4) Pregnancy; or (5) Prolonged corrected QT interval (>450 ms). Clinical data, including standard hospital biochemistry, medical therapy, vital signs, NEWS2, and microbiology results (including blood culture results and reverse transcriptase polymerase chain reaction [RT-PCR] for other upper airway viruses), will be automatically extracted from the hospital electronic records and merged with the study specific database.
INTERVENTION AND COMPARATOR
Included patients will be randomised in a 1:1 ratio to (1) standard care with the addition of 400 mg hydroxychloroquine sulphate (Plaquenil TM ) twice daily for seven days or (2) standard care alone.
MAIN OUTCOMES
The primary endpoint of the study is the rate of decline in SARS-CoV-2 viral load in oropharyngeal samples as assessed by RT-PCR in samples collected at baseline, 48 and 96 hours after randomization and administration of drug for the intervention arm. Secondary endpoints include change in NEWS2 at 96 hours after randomisation, admission to intensive care unit, mortality (in-hospital, and at 30 and 90 days), duration of hospital admission, clinical status on a 7-point ordinal scale 14 days after randomization ([1] Death [2] Hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation [3] Hospitalised, on non-invasive ventilation or high flow oxygen devices [4] Hospitalized, requiring supplemental oxygen [5] Hospitalised, not requiring supplemental oxygen [6] Not hospitalized, but unable to resume normal activities [7] Not hospitalised, with resumption of normal activities), and improvement in protein biomarker profiles (C-reactive protein, markers of renal and hepatic injury, and established cardiac biomarkers like cardiac troponin and B-type natriuretic peptide) at 96 hours after randomization.
RANDOMISATION
Eligible patients will be allocated in a 1:1 ratio, using a computer randomisation procedure. The allocation sequence has been prepared by an independent statistician.
BLINDING (MASKING)
Open label randomised controlled pragmatic trial without blinding, no active or placebo control. The virologist assessing viral load in the oropharyngeal samples and the statistician responsible for analysis of the data will be blinded to the treatment allocation for the statistical analyses.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)
This is a group sequential adaptive trial where analyses are planned after 51, 101, 151 and 202 completed patients, with a maximum sample size of 202 patients (101 patients allocated to intervention and standard care and 101 patients allocated to standard care alone).
TRIAL STATUS
Protocol version 1.3 (March 26, 2020). Recruitment of first patient on March 26, 2020, and 51 patients were included as per April 28, 2020. Study recruitment is anticipated to be completed by July 2020.
TRIAL REGISTRATION
ClinicalTrials.gov number, NCT04316377. Trial registered March 20, 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Prolonged corrected QT interval (>450 ms).,"['Recruitment of first patient on March 26, 2020, and 51 patients were included as per April 28, 2020', 'prospective patient at screening prior to inclusion: (1) Hospitalisation; (2) Adults 18 years or older; (3) Moderately severe Covid-19 disease (NEWS2 of 6 or less); (4) SARS-CoV-2 positive nasopharyngeal swab; (5) Expected time of hospitalisation > 48 hours; and (6) Signed informed consent must be obtained and documented according to Good Clinical Practice guidelines of the International Conference on Harmonization, and national/local regulations', 'moderately severe hospitalised patients with coronavirus disease 2019', 'patients with moderately severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'Patients will be excluded from participation in the study if they meet any of the following criteria: (1) Requiring intensive care unit admission at screening; (2) History of psoriasis; (3) Known adverse reaction to hydroxychloroquine sulphate; (4) Pregnancy; or (5', '4] Hospitalized, requiring supplemental oxygen [5] Hospitalised, not requiring supplemental oxygen [6] Not hospitalized, but unable to resume normal activities [7] Not hospitalised, with resumption of normal activities), and improvement in protein biomarker profiles (C-reactive protein, markers of renal and hepatic injury, and established cardiac biomarkers like cardiac troponin and B-type natriuretic peptide) at 96 hours after randomization', 'hospitalised patients with coronavirus disease 2019 (Covid-19', 'patients with established Covid-19', 'Patients will be recruited from all inpatients at Akershus University Hospital, Lørenskog, Norway', 'planned after 51, 101, 151 and 202 completed patients, with a maximum sample size of 202 patients (101 patients allocated to', 'Norwegian Coronavirus Disease 2019']","['hydroxychloroquine sulphate therapy', 'non-invasive ventilation or high flow oxygen devices', 'intervention and standard care and 101 patients allocated to standard care alone', 'placebo control', 'hydroxychloroquine sulphate (Plaquenil TM ) twice daily for seven days or (2) standard care alone', 'hydroxychloroquine sulphate']","['rate of decline in SARS-CoV-2 viral load in oropharyngeal samples as assessed by RT-PCR', 'Prolonged corrected QT interval', 'change in NEWS2 at 96 hours after randomisation, admission to intensive care unit, mortality (in-hospital, and at 30 and 90 days), duration of hospital admission, clinical status on a 7-point ordinal scale 14 days after randomization ([1] Death [2] Hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation', 'virological clearance rate']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0455567', 'cui_str': 'H/O: psoriasis'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine sulfate'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}]","[{'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine sulfate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699177', 'cui_str': 'Plaquenil'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",,0.36269,Prolonged corrected QT interval (>450 ms).,"[{'ForeName': 'Magnus Nakrem', 'Initials': 'MN', 'LastName': 'Lyngbakken', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Berdal', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Eskesen', 'Affiliation': 'Department of Infectious Diseases, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Kvale', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Inge Christoffer', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anbjørg', 'Initials': 'A', 'LastName': 'Rangberg', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Christine Monceyron', 'Initials': 'CM', 'LastName': 'Jonassen', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Omland', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Røsjø', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. helge.rosjo@medisin.uio.no.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Dalgard', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Trials,['10.1186/s13063-020-04420-0']
2795,32503663,Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
The hypothesis of the proposed intervention is that Granulocyte-macrophage colony-stimulating factor (GM-CSF) has profound effects on antiviral immunity, and can provide the stimulus to restore immune homeostasis in the lung with acute lung injury post COVID-19, and can promote lung repair mechanisms, that lead to a 25% improvement in lung oxygenation parameters. Sargramostim is a man-made form of the naturally-occurring protein GM-CSF.
TRIAL DESIGN
A phase 4 academic, prospective, 2 arm (1:1 ratio), randomized, open-label, controlled trial.
PARTICIPANTS
Patients aged 18-80 years admitted to specialized COVID-19 wards in 5 Belgian hospitals with recent (< 2 weeks prior to randomization) confirmed COVID-19 infection and acute respiratory failure defined as a PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen. Patients were excluded from the trial in case of (1) known serious allergic reactions to yeast-derived products, (2) lithium carbonate therapy, (3) mechanical ventilation prior to randomization, (4) peripheral white blood cell count above 25.000/μL and/or active myeloid malignancy, (5) high dose systemic steroid therapy (> 20 mg methylprednisolone or equivalent), (6) enrolment in another investigational study, (7) pregnant or breastfeeding or (8) ferritin levels > 2000 μg/mL.
INTERVENTION AND COMPARATOR
Inhaled sargramostim 125 μg twice daily for 5 days in addition to standard care. Upon progression of disease requiring mechanical ventilation or to acute respiratory distress syndrome (ARDS) and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125 μg/m 2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment. Intervention will be compared to standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards in the standard of care group will have the option (clinician's decision) to initiate IV sargramostim 125m μg/m 2 body surface area once daily for 5 days.
MAIN OUTCOMES
The primary endpoint of this intervention is measuring oxygenation after 5 days of inhaled (and intravenous) treatment through assessment of a change in pretreatment and post-treatment ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient (PAO2= Partial alveolar pressure of oxygen, PaO2=Partial arterial pressure of oxygen; FiO2= Fraction of inspired oxygen).
RANDOMISATION
Patients will be randomized in a 1:1 ratio. Randomization will be done using REDCap (electronic IWRS system).
BLINDING (MASKING)
In this open-label trial neither participants, caregivers, nor those assessing the outcomes will be blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
A total of 80 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be enrolled, 40 in the active and 40 in the control group.
TRIAL STATUS
SARPAC protocol Version 2.0 (April 15 2020). Participant recruitment is ongoing in 5 Belgian Hospitals (i.e. University Hospital Ghent, AZ Sint-Jan Bruges, AZ Delta Roeselare, University Hospital Brussels and ZNA Middelheim Antwerp). Participant recruitment started on March 26 th 2020. Given the current decline of the COVID-19 pandemic in Belgium, it is difficult to anticipate the rate of participant recruitment.
TRIAL REGISTRATION
The trial was registered on Clinical Trials.gov on March 30 th , 2020 (ClinicalTrials.gov Identifier: NCT04326920) - retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT04326920?term=sarpac&recrs=ab&draw=2&rank=1 and on EudraCT on March 24th, 2020 (Identifier: 2020-001254-22).
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['Patients aged 18-80 years admitted to specialized COVID-19 wards in 5 Belgian hospitals with recent (< 2 weeks prior to randomization) confirmed COVID-19 infection and acute respiratory failure defined as a', 'on March 24th, 2020', 'Patients were excluded from the trial in case of (1) known serious allergic reactions to yeast-derived products, (2) lithium carbonate therapy, (3) mechanical ventilation prior to randomization, (4) peripheral white blood cell count above 25.000/μL and/or active myeloid malignancy, (5) high dose systemic steroid therapy (> 20 mg methylprednisolone or equivalent), (6) enrolment in another investigational study, (7) pregnant or breastfeeding or (8) ferritin levels ', '2000', 'patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC', '80 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be enrolled, 40 in the active and 40 in the control group']","['https://clinicaltrials.gov/ct2/show/NCT04326920?term=sarpac&recrs=ab&draw=2&rank=1 and on EudraCT', 'Sargramostim', 'Inhaled sargramostim', 'PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen']","['measuring oxygenation after 5 days of inhaled (and intravenous) treatment through assessment of a change in pretreatment and post-treatment ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient (PAO2= Partial alveolar pressure of oxygen, PaO2=Partial arterial pressure of oxygen; FiO2= Fraction of inspired oxygen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0085217', 'cui_str': 'Lithium Carbonate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2939461', 'cui_str': 'Myeloid neoplasm'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0216231', 'cui_str': 'sargramostim'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0232010', 'cui_str': 'Alveolar pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",80.0,0.333777,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium. bastiaan.maes@irc.vib-ugent.be.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Willaert', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bollé', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vanbiervliet', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Decuypere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Libeer', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Lambrecht', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04451-7']
2796,32503727,Adenosine A2A receptor agonist (regadenoson) in human lung transplantation.,"BACKGROUND
Currently, there are no clinically approved treatments for ischemia-reperfusion injury after lung transplantation. Pre-clinical animal models have demonstrated a promising efficacy of adenosine 2A receptor (A 2A R) agonists as a treatment option for reducing ischemia-reperfusion injury. The purpose of this human study, is to conduct a Phase I clinical trial for evaluating the safety of continuous infusion of an A 2A R agonist in lung transplant recipients.
METHODS
An adaptive, two-stage continual reassessment trial was designed to evaluate the safety of regadenoson (A 2A R agonist) in the setting of lung transplantation. Continuous infusion of regadenoson was administered to lung transplant recipients that was started at the time of skin incision. Adverse events and dose-limiting toxicities, as pre-determined by a study team and assessed by a clinical team and an independent safety monitor, were the primary end-points for safety in this trial.
RESULTS
Between January 2018 and March 2019, 14 recipients were enrolled in the trial. Of these, 10 received the maximum infused dose of 1.44 µg/kg/min for 12 hours. No dose-limiting toxicities were observed. The steady-state plasma regadenoson levels sampled before the reperfusion of the first lung were 0.98 ± 0.46 ng/ml. There were no mortalities within 30 days.
CONCLUSIONS
Regadenoson, an A 2A R agonist, can be safely infused in the setting of lung transplantation with no dose-limiting toxicities or drug-related mortality. Although not powered for the evaluation of secondary end-points, the results of this trial and the outcome of pre-clinical studies warrant further investigation with a Phase II randomized controlled trial.",2020,"There were no mortalities within 30 days.
","['lung transplant recipients', 'Between January 2018 and March 2019, 14 recipients were enrolled in the trial', 'human lung transplantation']","['2A R agonist', 'regadenoson', 'regadenoson (A 2A R agonist', 'Adenosine A2A receptor agonist (regadenoson']","['No dose-limiting toxicities', 'steady-state plasma regadenoson levels', 'Adverse events and dose-limiting toxicities']","[{'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1698215', 'cui_str': 'regadenoson'}, {'cui': 'C2936552', 'cui_str': 'Adenosine A2A Receptor Agonists'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1698215', 'cui_str': 'regadenoson'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",14.0,0.0547169,"There were no mortalities within 30 days.
","[{'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Lau', 'Affiliation': 'Department of Surgery, University of Maryland, Baltimore, Maryland. Electronic address: CLLau@som.umaryland.edu.'}, {'ForeName': 'Jared P', 'Initials': 'JP', 'LastName': 'Beller', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Boys', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Department of Surgery, University of California, San Diego, California.'}, {'ForeName': 'Yunge', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Surgery, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cosner', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Conaway', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Petroni', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Charles', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Mehaffey', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Mannem', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Irving L', 'Initials': 'IL', 'LastName': 'Kron', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia; Department of Surgery, University of Arizona Health Sciences, Tucson, Arizona.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Krupnick', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Linden', 'Affiliation': 'Division of Developmental Immunology, La Jolla Institute for Immunology and Department of Pharmacology, University of California, San Diego, California.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.02.003']
2797,32503866,Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.,"INTRODUCTION
Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD.
METHODS AND ANALYSIS
The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months.
ETHICS AND DISSEMINATION
Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.",2020,"Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle.","['peripheral artery disease', 'patients with PAD', '1760 patients diagnosed with PAD at Fontaine stage II']","['Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach', 'usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle', 'TeGeCoach or care-as-usual', 'TeGeCoach']","['walking ability based on the Walking Impairment Questionnaire', 'quality of life, health literacy and health behaviour', 'walking impairment']","[{'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",1760.0,0.109017,"Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle.","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Rezvani', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany f.rezvani@uke.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Heider', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bienert', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brinkmann', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Herbarth', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Kramer', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Steinisch', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Freudenstein', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Terhalle', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Grosse', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Bock', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Posselt', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Beutel', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Reif', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kirchhoff', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Neuschwander', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Löffler', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brunner', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dickmeis', 'Affiliation': 'IEM GmbH, Stolberg, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenthal', 'Affiliation': 'IEM GmbH, Stolberg, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schmitz', 'Affiliation': 'Philips Germany GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Daniela Patricia', 'Initials': 'DP', 'LastName': 'Chase', 'Affiliation': 'Philips Germany GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Seelenmeyer', 'Affiliation': 'Dr Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Baden-Württemberg, Germany.'}, {'ForeName': 'Mark Dominik', 'Initials': 'MD', 'LastName': 'Alscher', 'Affiliation': 'Dr Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Baden-Württemberg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Department of Sports Medicine, Hannover Medical School, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-032146']
2798,32503867,"Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application.","INTRODUCTION
With the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing.
METHODS AND ANALYSIS
Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later.
ETHICS AND DISSEMINATION
This protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov registry (NCT03793946). Stage; pre-results.",2020,"METHODS AND ANALYSIS
Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland.","['hospitals', 'At participating wards, patients of at least 18 years of age using antimicrobials will be included']","['smartphone-based digital stewardship applications', 'digital antimicrobial stewardship smartphone application']","['antimicrobial use metrics, clinical and process outcomes']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",15.0,0.275037,"METHODS AND ANALYSIS
Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland.","[{'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Helou', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gaud', 'Initials': 'G', 'LastName': 'Catho', 'Affiliation': 'Department of Infectious Diseases, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Peyravi Latif', 'Affiliation': 'Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mouton', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hulscher', 'Affiliation': 'Scientific Center for Quality of Healthcare (IQ Healthcare), Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conly', 'Affiliation': 'Department of Medicine, University of Calgary and Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Benedikt D', 'Initials': 'BD', 'LastName': 'Huttner', 'Affiliation': 'Department of Infectious Diseases, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tängdén', 'Affiliation': 'Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands a.verbon@erasmusmc.nl.'}]",BMJ open,['10.1136/bmjopen-2019-033640']
2799,32503869,Psychosocial consequences of false positives in the Danish Lung Cancer CT Screening Trial: a nested matched cohort study.,"OBJECTIVES
Lung cancer CT screening can reduce lung cancer mortality, but high false-positive rates may cause adverse psychosocial consequences. The aim was to analyse the psychosocial consequences of false-positive lung cancer CT screening using the lung cancer screening-specific questionnaire, Consequences of Screening in Lung Cancer (COS-LC).
DESIGN AND SETTING
This study was a matched cohort study, nested in the randomised Danish Lung Cancer Screening Trial (DLCST).
PARTICIPANTS
Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire. Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group. The true positives and false positives were also matched 1:2 with participants with negative CT screening results (n=252).
PRIMARY OUTCOMES
Primary outcomes were psychosocial consequences measured at five time points.
RESULTS
False positives experienced significantly more negative psychosocial consequences in seven outcomes at 1 week and in three outcomes at 1 month compared with the control group and the true-negative group (mean ∆ score >0 and p<0.001). True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group. No long-term psychosocial consequences were identified either in false positives or true positives.
CONCLUSIONS
Receiving a false-positive result in lung cancer screening was associated with negative short-term psychosocial consequences. These findings contribute to the evidence on harms of screening and should be taken into account when considering implementation of lung cancer screening programmes.
TRIAL REGISTRATION NUMBER
NCT00496977.",2020,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","['Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire', 'Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group']",['false-positive lung cancer CT screening'],"['lung cancer mortality', 'psychosocial consequences measured at five time points', 'lung cancer screening', 'Psychosocial consequences of false positives', 'true positives and false positives', 'negative psychosocial consequences', 'false positives or true positives']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0269201,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","[{'ForeName': 'Jakob Fraes', 'Initials': 'JF', 'LastName': 'Rasmussen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Malmqvist', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark jessica.malmqvist@sund.ku.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034682']
2800,32503877,Inhibition of Bruton tyrosine kinase in patients with severe COVID-19.,"Patients with severe COVID-19 have a hyperinflammatory immune response suggestive of macrophage activation. Bruton tyrosine kinase (BTK) regulates macrophage signaling and activation. Acalabrutinib, a selective BTK inhibitor, was administered off-label to 19 patients hospitalized with severe COVID-19 (11 on supplemental oxygen; 8 on mechanical ventilation), 18 of whom had increasing oxygen requirements at baseline. Over a 10-14 day treatment course, acalabrutinib improved oxygenation in a majority of patients, often within 1-3 days, and had no discernable toxicity. Measures of inflammation - C-reactive protein and IL-6 - normalized quickly in most patients, as did lymphopenia, in correlation with improved oxygenation. At the end of acalabrutinib treatment, 8/11 (72.7%) patients in the supplemental oxygen cohort had been discharged on room air, and 4/8 (50%) patients in the mechanical ventilation cohort had been successfully extubated, with 2/8 (25%) discharged on room air. Ex vivo analysis revealed significantly elevated BTK activity, as evidenced by autophosphorylation, and increased IL-6 production in blood monocytes from patients with severe COVID-19 compared with blood monocytes from healthy volunteers. These results suggest that targeting excessive host inflammation with a BTK inhibitor is a therapeutic strategy in severe COVID-19 and has led to a confirmatory international prospective randomized controlled clinical trial.",2020,"Measures of inflammation - C-reactive protein and IL-6 - normalized quickly in most patients, as did lymphopenia, in correlation with improved oxygenation.","['19 patients hospitalized with severe COVID-19 (11 on supplemental oxygen; 8 on mechanical ventilation), 18 of whom had increasing oxygen requirements at baseline', 'patients with severe COVID-19']","['Bruton tyrosine kinase (BTK', 'BTK inhibitor']","['inflammation - C-reactive protein and IL-6 - normalized quickly', 'elevated BTK activity', 'discernable toxicity', 'IL-6 production in blood monocytes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C4521488', 'cui_str': 'Non-specific protein-tyrosine kinase inhibitor'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}]",,0.111792,"Measures of inflammation - C-reactive protein and IL-6 - normalized quickly in most patients, as did lymphopenia, in correlation with improved oxygenation.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Roschewski', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Michail S', 'Initials': 'MS', 'LastName': 'Lionakis', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Roswarski', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Goy', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'M Andrew', 'Initials': 'MA', 'LastName': 'Monticelli', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roshon', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Wrzesinski', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Jigar V', 'Initials': 'JV', 'LastName': 'Desai', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Marissa A', 'Initials': 'MA', 'LastName': 'Zarakas', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Collen', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hamdy', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Wright', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Chung', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Staudt', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD wilsonw@mail.nih.gov.""}]",Science immunology,['10.1126/sciimmunol.abd0110']
2801,32503946,Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.,"BACKGROUND
We have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.
METHODS
This randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.
RESULTS
At a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 months (95% CI 9.9 to 13.3) at 3 mg/kg (HR 0.84, 95% CI 0.71 to 0.99; p=0.04). In a subgroup analysis, median OS of patients with asymptomatic brain metastasis was 7.0 months (95% CI 4.0 to 12.8) in the 10 mg/kg group and 5.7 months (95% CI 4.2 to 7.0) in the 3 mg/kg group. In patients with wild-type or mutant BRAF tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively. The incidence of grade 3/4 treatment-related AEs was 36% in the 10 mg/kg group vs 20% in the 3 mg/kg group, and deaths due to treatment-related AEs occurred in four (1%) and two patients (1%), respectively.
CONCLUSIONS
This 61-month follow-up of a phase III trial showed sustained long-term survival in patients with advanced melanoma who started metastatic treatment with ipilimumab monotherapy, and confirmed the significant benefit for those who received ipilimumab 10 mg/kg vs 3 mg/kg. These results suggest the emergence of a plateau in the OS curve, consistent with previous ipilimumab studies.
TRIAL REGISTRATION NUMBER
NCT01515189.",2020,"In patients with wild-type or mutant BRAF tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","['patients with advanced melanoma', 'patients with untreated or previously treated unresectable stage III or IV melanoma', 'patients with advanced melanoma who started metastatic treatment with']","['ipilimumab monotherapy', 'ipilimumab']","['OS', 'median OS', 'Overall survival', 'sustained long-term survival', 'median OS of patients with asymptomatic brain metastasis', 'overall survival (OS', 'incidence of grade 3/4 treatment-related AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.585321,"In patients with wild-type or mutant BRAF tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","[{'ForeName': 'Paolo Antonio', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy paolo.ascierto@gmail.com.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Del Vecchio', 'Affiliation': 'Unit of Melanoma Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mackiewicz', 'Affiliation': 'Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Center, Poznan Medical University, Poznan, Poland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Medicine, Dermatology Service, Gustave Roussy, Villejuif and Paris-Sud-University, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Oncology Unit, Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': ""Hospital Clinic and Institut D'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'Université de Paris, INSERM, Dermatology and CIC, Saint Louis Hospital, Paris, France.'}, {'ForeName': 'Inge Marie', 'Initials': 'IM', 'LastName': 'Svane', 'Affiliation': 'Center for Cancer Immune Therapy, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse and Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Skłodowska-Curie Institute-Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': ""Clinique de Dermatologie, Unité d'Onco-Dermatologie, INSERM U1189, Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.""}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Melanoma Center, The Angeles Clinic and Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreno', 'Affiliation': 'Department of Oncodermatology, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, Eberhard Karls Universitat Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancers Department, Aix-Marseille University, APHM, Marseille, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Liszkay', 'Affiliation': 'Department of Oncodermatology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': 'Department of Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoeller', 'Affiliation': 'Division of General Dermatology and Dermato-Oncology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Unit of Medical Oncology, IRCCS-Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Grange', 'Affiliation': 'Department of Dermatology, University Hospital Centre Reims, Reims, Champagne-Ardenne, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Operative Dermatology and Dermato-Oncology, Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pikiel', 'Affiliation': 'Department of Oncology, Wojewodzkie Centrum Oncologii, Gdańsk, Poland.'}, {'ForeName': 'Fareeda', 'Initials': 'F', 'LastName': 'Hosein', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Burcin', 'Initials': 'B', 'LastName': 'Simsek', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Instituto Toscano Tumori, Siena, Italy.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000391']
2802,32503948,Early tumor shrinkage identifies long-term disease control and survival in patients with lung cancer treated with atezolizumab.,"BACKGROUND
Preliminary evidence indicates that early tumor shrinkage (ETS) following immune checkpoint inhibitor (ICI) initiation may be associated with survival outcomes in patients with advanced melanoma. ETS has not been explored as a biomarker of survival outcomes or patient-reported outcomes in patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs.
METHODS
The study pooled data from patients with NSCLC in the randomized trials OAK and POPLAR (atezolizumab vs docetaxel; n=1464), and single-arm atezolizumab trials BIRCH and FIR (n=797). The association between ETS (≥10% decrease in pretreatment sum-of-longest diameters of target-lesions at 6 weeks) and overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF) was assessed using Cox proportional hazard analysis.
RESULTS
ETS occurred in 20% of atezolizumab-treated patients with NSCLC within OAK and POPLAR and was associated with highly favorable OS (HR 0.33, p<0.001), PFS (HR 0.31, p<0.001), TDD in HRQoL (HR 0.73, p=0.01) and PF (HR 0.52, p<0.001). The results were replicated in the BIRCH and FIR data. Atezolizumab-treated patients achieving ETS had markedly improved OS compared with docetaxel-treated patients achieving ETS (24-month OS 55% vs 32%); PFS was also markedly improved (24-month PFS 31% vs 4%). In contrast, for patients not achieving ETS, atezolizumab-treatment was associated with more modest OS (24-month OS 23% vs 20%) and PFS (24-month PFS 3% vs 1%) improvement compared with docetaxel. Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
CONCLUSIONS
ETS is an easily measurable biomarker, predictive of highly favorable survival and patient-reported outcomes with atezolizumab treatment for advanced NSCLC. Further, ETS identifies patients with significantly greater treatment benefit for ICI therapy.",2020,"Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
","['patients with advanced melanoma', 'patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs', 'patients with lung cancer treated with', 'patients with NSCLC']","['atezolizumab', 'POPLAR (atezolizumab vs docetaxel', 'docetaxel', 'Atezolizumab-treated patients achieving ETS']","['modest OS', 'PFS', 'OS', 'effect size for ETS', 'overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF', 'TDD in HRQoL', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0522458', 'cui_str': 'Populus'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0183841', 'cui_str': 'TDD'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.160724,"Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia ashley.hopkins@flinders.edu.au.'}, {'ForeName': 'Ganessan', 'Initials': 'G', 'LastName': 'Kichenadasse', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Chris S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000500']
2803,32504178,"Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years.","INTRODUCTION
The use of quadriceps tendon-patellar bone (QTB) autograft for anterior cruciate ligament (ACL) reconstruction is gaining momentum. Yet, long-term results that compare this procedure with established methods are lacking. The aim of this study was to report and compare long-term results of ACL reconstruction using QTB autografts versus bone-patellar tendon-bone (BPTB) autografts, both anchored using a hardware-free press-fit fixation technique.
MATERIALS AND METHODS
60 athletes (Tegner score ≥6) with primary ACL rupture were prospectively randomized into two groups. 56 patients were evaluated after a mean duration of 12.2 ± 1.9 months (range 10-14) and 43 patients after 10.3 ± 0.2 years (range 10-11).
RESULTS
On final follow-up, 90% of patients scored very good and good results in the functional Lysholm score (mean 99 ± 7.1, range 74-100 points). Normal or almost normal IKDC score was reported by 84% of the patients (mean 97 ± 9.5, range 60-100 points). The activity level decreased in the Tegner score from median of 7 before injury to 6 after 10 years. The KT-1000 arthrometer showed a difference in the anterior translation of less than 3 mm (mean 1.0 ± 1.2, range - 1 to 5 mm) in 91% of the patients. Significant degeneration was radiologically detected in one patient per group. No tunnel widening was seen in any patient. Up to 97% of all patients were satisfied with the operative procedure. No significant differences were found in the mentioned parameters between the two groups and also in comparison with the 1-year results. The only significant difference was in the donor site morbidity. Significantly more patients in the BPTB group had complaints during kneeling both at 1 (p < 0.001) and 10 years (p = 0.019). Squatting was also subjectively more problematic in the BPTB group than in the QTB group both after 1 (p = 0.003) and 10 years (p = 0.046).
CONCLUSIONS
This study shows equally good functional, clinical and radiological long-term results for both hardware-free methods of ACL reconstruction. These results clinically confirm the safety of press-fit anchoring after 10 years. The failure rate in this study was very low, with only one re-rupture in 10 years. The increased donor site morbidity when using the BPTB autograft compared to the QTB autograft supports already reported data. It was also seen in this study for the implant-free press-fit techniques.
STUDY DESIGN
Prospective and randomized, level of evidence 2.",2020,No significant differences were found in the mentioned parameters between the two groups and also in comparison with the 1-year results.,"['56 patients were evaluated after a mean duration of 12.2\u2009±\u20091.9\xa0months (range 10-14) and 43 patients after 10.3\u2009±\u20090.2\xa0years (range 10-11', 'athletes after 10\xa0years', '60 athletes (Tegner score ≥6) with primary ACL rupture']","['ACL reconstruction using QTB autografts versus bone-patellar tendon-bone (BPTB) autografts', 'quadriceps tendon-patellar bone (QTB) autograft for anterior cruciate ligament (ACL) reconstruction', 'QTB', 'Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique']","['Significant degeneration', 'activity level', 'tunnel widening', 'failure rate', 'functional Lysholm score', 'donor site morbidity', 'anterior translation', 'stability, function and return-to-sport level', 'Normal or almost normal IKDC score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0224941', 'cui_str': 'Structure of quadriceps tendon'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0441550', 'cui_str': 'Press-fit component fixation'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",56.0,0.0289652,No significant differences were found in the mentioned parameters between the two groups and also in comparison with the 1-year results.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Barié', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Clinic for Orthopedics and Trauma Surgery, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany. abarie@web.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sprinckstub', 'Affiliation': 'Center for Surgery B. Nimis and Dr. T. Sprinckstub, Zur Helde 4, 69168, Wiesloch, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Center for Orthopedics of the Knee, Hopfenstraße 4, 69469, Weinheim, Germany.'}, {'ForeName': 'Ayham', 'Initials': 'A', 'LastName': 'Jaber', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Clinic for Orthopedics and Trauma Surgery, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03508-1']
2804,32504207,Randomised-controlled feasibility trial on abdominal wall closure techniques in patients undergoing relaparotomy (ReLap study; DRKS00013001).,"BACKGROUND
Patients undergoing relaparotomy are generally underrepresented in clinical trials, despite how common the procedure is in clinical practice. Specifically, techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. The aim of this trial was to identify the optimal abdominal wall closure technique in patients undergoing relaparotomy.
METHODS
In this monocentric, randomised feasibility trial, patients scheduled for elective relaparotomy were randomised to abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop. Patients' postoperative courses were followed for 1 year after the index operation. Effectiveness and safety outcomes were compared at a level of significance of 5% between the two techniques.
RESULTS
A total of 100 out of 131 patients (76.3%) were evenly randomised to the small stitches and large stitches groups. The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334). The overall comprehensive complication index was 14.4 ± 15.5 in the small stitches group and 19.9 ± 23.4 in the large stitches group (p = 0.168). Specifically, rates of surgical site infection (small stitches 30.0% versus large stitches 36.0%; p = 0.524) and burst abdomen (small stitches 4.0% versus large stitches 0.0%; p = 0.495) did not differ. After 1 year, incisional hernia rate was 7.5% in the small stitches group and 10.0% in the large stitches group (p > 0.999).
DISCUSSION
Both abdominal wall closure techniques investigated in this trial were feasible in relaparotomy patients. This exploratory trial revealed no noticeable difference in the effectiveness or safety of the small stitches technique with Monomax® 2-0 versus the large stitches technique with PDS II® 1 loop. Therefore, surgeons should stay with their preferred suture technique in relaparotomy patients.
TRIAL REGISTRATION
Deutsches Register Klinischer Studien (www.germanctr.de): DRKS00013001.",2020,The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334).,"['patients undergoing relaparotomy (ReLap study', 'patients scheduled for elective relaparotomy', 'relaparotomy patients', 'A total of 100 out of 131 patients (76.3', 'patients undergoing relaparotomy']","['abdominal wall closure techniques', 'abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop']","['burst abdomen', 'Effectiveness and safety outcomes', 'rates of surgical site infection', 'incisional hernia rate', 'overall comprehensive complication index', 'time for abdominal wall closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0023035', 'cui_str': 'Suture of abdominal wall'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0085242', 'cui_str': 'Polydioxanone'}, {'cui': 'C0445022', 'cui_str': 'Loop'}]","[{'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023035', 'cui_str': 'Suture of abdominal wall'}]",131.0,0.176231,The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334).,"[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. pascal.probst@med.uni-heidelberg.de.'}, {'ForeName': 'Dinh Thien-An', 'Initials': 'DT', 'LastName': 'Tran', 'Affiliation': 'The Study Center of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Harnoss', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heger', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Alina S', 'Initials': 'AS', 'LastName': 'Ritter', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Doerr-Harim', 'Affiliation': 'The Study Center of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01903-1']
2805,32504217,Cleansing efficacy of an auto-cleaning electronic toothbrushing device: a randomized-controlled crossover pilot study.,"OBJECTIVES
To compare the cleansing efficacy of a representative ""ten seconds"" auto-cleaning device with that of uninstructed manual toothbrushing in a pilot study.
MATERIALS AND METHODS
Twenty periodontally healthy probands refrained from oral hygiene for 3 days. Baseline full-mouth plaque scores (Rustogi Modified Navy Plaque Index, RMNPI) were assessed. After randomization, probands cleaned their teeth either with the auto-cleaning test device according to the manufacturer's protocol or with a manual toothbrush. Plaque reduction was assessed by two aligned blinded investigators. After a 2-week recovery, the clinical investigation was repeated in a crossover design. The brushing pattern of the auto-cleaning device was analyzed in probands' casts.
RESULTS
Full-mouth plaque reduction was 11.37 ± 3.70% for the auto-cleaning device and 31.39 ± 5.27% for manual toothbrushing (p < 0.0001). The investigation of the auto-cleaning device's brushing pattern in dental casts revealed a positive relationship of bristle rows in contact with tooth surfaces and the cleansing efficacy in the respective areas. A maximum of 2/4 bristle rows were in contact with the tooth surfaces; in some areas, the bristles had no contact to the teeth.
CONCLUSIONS
Uninstructed manual toothbrushing is superior to auto-cleaning. The alignment and density of the auto-cleaning device's bristle rows need to be improved, and assorted sizes would be necessary to cover different jaw shapes.
CLINICAL RELEVANCE
The auto-cleaning device has been developed to accommodate individuals with poor dexterity or compliance. To date, it is unable to provide sufficient plaque reduction due to an inappropriate bristle alignment and poor fit with diverse dental arches.",2020,"RESULTS
Full-mouth plaque reduction was 11.37 ± 3.70% for the auto-cleaning device and 31.39 ± 5.27% for manual toothbrushing (p < 0.0001).",['Twenty periodontally healthy probands refrained from oral hygiene for 3\xa0days'],"['representative ""ten seconds"" auto-cleaning device with that of uninstructed manual toothbrushing', 'auto-cleaning electronic toothbrushing device']","['Plaque reduction', 'Cleansing efficacy', 'Full-mouth plaque reduction', 'cleansing efficacy', 'Baseline full-mouth plaque scores (Rustogi Modified Navy Plaque Index, RMNPI']","[{'cui': 'C0702111', 'cui_str': 'Proband'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",20.0,0.0681159,"RESULTS
Full-mouth plaque reduction was 11.37 ± 3.70% for the auto-cleaning device and 31.39 ± 5.27% for manual toothbrushing (p < 0.0001).","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schnabl', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Wiesmüller', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Hönlinger', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wimmer', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Bruckmoser', 'Affiliation': 'Private Practice for Oral and Maxillofacial Surgery, 5020, Salzburg, Austria.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Kapferer-Seebacher', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria. Ines.Kapferer@i-med.ac.at.'}]",Clinical oral investigations,['10.1007/s00784-020-03359-5']
2806,32504272,"Validation of a Drug Transporter Probe Cocktail Using the Prototypical Inhibitors Rifampin, Probenecid, Verapamil, and Cimetidine.","BACKGROUND AND OBJECTIVE
A novel cocktail containing four substrates of key drug transporters was previously optimized to eliminate mutual drug-drug interactions between the probes digoxin (P-glycoprotein substrate), furosemide (organic anion transporter 1/3), metformin (organic cation transporter 2, multidrug and toxin extrusion protein 1/2-K), and rosuvastatin (organic anion transporting polypeptide 1B1/3, breast cancer resistance protein). This clinical trial investigated the effects of four commonly employed drug transporter inhibitors on cocktail drug pharmacokinetics.
METHODS
In a randomized open-label crossover trial in 45 healthy male subjects, treatment groups received the cocktail with or without single oral doses of rifampin, verapamil, cimetidine or probenecid. Concentrations of the probe drugs in serial plasma samples and urine fractions were measured by validated liquid chromatography-tandem mass spectrometry assays to assess systemic exposure.
RESULTS
The results were generally in accordance with known in vitro and/or clinical drug-drug interaction data. Single-dose rifampin increased rosuvastatin area under the plasma concentration-time curve up to the last quantifiable concentration (AUC 0-tz ) by 248% and maximum plasma concentration (C max ) by 1025%. Probenecid increased furosemide AUC 0-tz by 172% and C max by 23%. Cimetidine reduced metformin renal clearance by 26%. The effect of single-dose verapamil on digoxin systemic exposure was less than expected from multiple-dose studies (AUC 0-tz unaltered, C max + 22%).
CONCLUSIONS
Taking all the interaction results together, the transporter cocktail is considered to be validated as a sensitive and specific tool for evaluating transporter-mediated drug-drug interactions in drug development.
CLINICAL TRIAL REGISTRATION
EudraCT number 2017-001549-29.",2020,Single-dose rifampin increased rosuvastatin area under the plasma concentration-time curve up to the last quantifiable concentration (AUC 0-tz ) by 248% and maximum plasma concentration (C max ) by 1025%.,['45 healthy male subjects'],"['verapamil', 'furosemide (organic anion transporter 1/3), metformin (organic cation transporter 2, multidrug and toxin extrusion protein 1/2-K), and rosuvastatin', 'Probenecid, Verapamil, and Cimetidine', 'Cimetidine', 'cocktail with or without single oral doses of rifampin, verapamil, cimetidine or probenecid', 'Probenecid']","['serial plasma samples and urine fractions', 'metformin renal clearance', 'digoxin systemic exposure', 'furosemide AUC 0-tz']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0949791', 'cui_str': 'OATP Proteins'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1453694', 'cui_str': 'SLC22A2 protein, human'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0033209', 'cui_str': 'Probenecid'}, {'cui': 'C0008783', 'cui_str': 'Cimetidine'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",45.0,0.0787025,Single-dose rifampin increased rosuvastatin area under the plasma concentration-time curve up to the last quantifiable concentration (AUC 0-tz ) by 248% and maximum plasma concentration (C max ) by 1025%.,"[{'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Wiebe', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Giessmann', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Hohl', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schmidt-Gerets', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Hauel', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Jambrecina', 'Affiliation': 'CTC North GmbH & Co KG, University Medical Centre Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Bader', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ishiguro', 'Affiliation': 'Kobe Pharma Research Institute, Nippon Boehringer Ingelheim Co. Ltd., Chuo-ku, Kobe, Japan.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Taub', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ebner', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Mikus', 'Affiliation': 'UniversitätsKlinikum Heidelberg-Medizinische Klinik, Abteilung Klinische Pharmakologie and Pharmakoepidemiologie, Heidelberg, Germany.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Fromm', 'Affiliation': 'Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stopfer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany. Peter.Stopfer@boehringer-ingelheim.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00907-w']
2807,32504284,"N083E (Alliance): long-term outcomes of patients treated in a pilot phase II study of docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy for early-stage HER2-positive breast cancer.","BACKGROUND
The addition of lapatinib (L) to trastuzumab (T) was previously found to be synergistic in preclinical models and in the neoadjuvant setting. Prior to the results of the ALTTO trial, this study assessed the safety and feasibility of adding L to the standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen in early-stage HER2-positive breast cancer (HER2+ BC).
METHODS
In this single-arm, 2-stage, phase II study, patients with stages I-III HER2+ BC received TCH plus L at 1000 mg daily for a total of 12 months. The primary endpoint was the safety and tolerability, including the rate of diarrhea. Secondary endpoints included adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety.
RESULTS
Thirty eligible patients were enrolled. Median follow-up is 5.3 years. Diarrhea was the most common AE with 50% Grade (G)1/2 and 43% G3 diarrhea. However, it was responsive to dose reduction of L (750 mg) and institution of anti-diarrheal medications. Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment.
CONCLUSION
TCHL was a tolerable regimen at a starting L dose of 750 mg PO daily when given concurrently with chemotherapy.",2020,"Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment.
","['early-stage HER2-positive breast cancer (HER2+\u2009BC', 'Thirty eligible patients were enrolled', 'early-stage HER2-positive breast cancer']","['standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen', 'TCH plus L', 'lapatinib (L) to trastuzumab (T', 'docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy', 'N083E', 'TCHL']","['safety and tolerability', 'rate of diarrhea', 'Cardiovascular AE', 'congestive heart failure', 'Diarrhea', 'adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",30.0,0.0277203,"Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment.
","[{'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Leon-Ferre', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Celyne', 'Initials': 'C', 'LastName': 'Bueno', 'Affiliation': 'Department of General Oncology, MD Anderson Cancer Center Bay Area, Nassau Bay, TX, USA.'}, {'ForeName': 'Alejandra T', 'Initials': 'AT', 'LastName': 'Perez', 'Affiliation': 'Breast Cancer Centers, Memorial Cancer Institute, Hollywood, FL, USA.'}, {'ForeName': 'Beiyun', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Jenkins', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Johnson', 'Affiliation': 'Department of Hematology/Oncology, Wichita Community Clinical Oncology Program, Wichita, KS, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Carolla', 'Affiliation': 'Department of Hematology/Oncology, Cancer Research for the Ozarks, Springfield, MO, USA.'}, {'ForeName': 'Robin T', 'Initials': 'RT', 'LastName': 'Zon', 'Affiliation': 'Department of Oncology, North Indiana Cancer Research Consortium CCOP, South Bend, IN, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA. morenoaspitia.alvaro@mayo.edu.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05709-z']
2808,32504314,Analysis of C. difficile infection-related outcomes in European participants in the bezlotoxumab MODIFY I and II trials.,"The MODIFY I/II trials demonstrated that bezlotoxumab, a human monoclonal antibody against Clostridioides difficile toxin B, given during antibiotic treatment for Clostridioides difficile infection (CDI) significantly reduced C. difficile recurrence (rCDI) in adults at high risk for rCDI. Efficacy of CDI-directed intervention may depend on ribotype regional epidemiology, and patient characteristics. This post hoc analysis assessed the efficacy of bezlotoxumab in the subgroup of MODIFY I/II trial participants enrolled in Europe. Data from the bezlotoxumab (10 mg/kg single intravenous infusion) and placebo (0.9% saline) groups from MODIFY I/II were compared to assess initial clinical cure (ICC), rCDI, all-cause, and CDI-associated rehospitalizations within 30 days of discharge, and mortality through 12 weeks post-infusion. Of 1554 worldwide participants, 606 were from Europe (bezlotoxumab n = 313, 51%; placebo n = 292; 48%). Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%). Fifty-five percent of participants were female, and 86% were hospitalized at randomization. The rate of ICC was similar between treatment groups. The rate of rCDI in the bezlotoxumab group was lower compared with placebo among European participants overall, and among those with ≥ 1 risk factor for rCDI. Bezlotoxumab reduced 30-day CDI-associated rehospitalizations compared with placebo. These results are consistent with overall results from the MODIFY trials and demonstrate that bezlotoxumab reduces rCDI and CDI-associated rehospitalizations in European patients with CDI. MODIFY I/II (NCT01241552 and NCT01513239).",2020,"Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%).","['Fifty-five percent of participants were female, and 86% were hospitalized at randomization', 'adults at high risk for rCDI', 'Of 1554 worldwide participants, 606 were from Europe (bezlotoxumab n = 313, 51%; placebo n = 292; 48', 'European participants in the bezlotoxumab MODIFY I and II trials', 'European patients with CDI', 'subgroup of MODIFY I/II trial participants enrolled in Europe']","['bezlotoxumab', 'CDI-directed intervention', 'Bezlotoxumab', 'placebo']","['initial clinical cure (ICC), rCDI, all-cause, and CDI-associated rehospitalizations within 30 days of discharge, and mortality', 'rate of rCDI', 'rate of ICC', '30-day CDI-associated rehospitalizations']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}]","[{'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}]",1554.0,0.572207,"Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%).","[{'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Bouza', 'Affiliation': 'University Complutense of Madrid, Madrid, Spain.'}, {'ForeName': 'Oliver A', 'Initials': 'OA', 'LastName': 'Cornely', 'Affiliation': 'Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM); Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD); Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ramos-Martinez', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plesniak', 'Affiliation': 'University of Rzeszów Medical Center, Łańcut, Poland.'}, {'ForeName': 'Misoo C', 'Initials': 'MC', 'LastName': 'Ellison', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Hanson', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. mary.beth.dorr@merck.com.'}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-020-03935-3']
2809,31091136,Development and Validation of a Cytogenetic Prognostic Index Predicting Survival in Multiple Myeloma.,"PURPOSE
The wide heterogeneity in multiple myeloma (MM) outcome is driven mainly by cytogenetic abnormalities. The current definition of high-risk profile is restrictive and oversimplified. To adapt MM treatment to risk, we need to better define a cytogenetic risk classification. To address this issue, we simultaneously examined the prognostic impact of del(17p); t(4;14); del(1p32); 1q21 gain; and trisomies 3, 5, and 21 in a cohort of newly diagnosed patients with MM.
METHODS
Data were obtained from 1,635 patients enrolled in four trials implemented by the Intergroupe Francophone du Myélome. The oldest collection of data were used for model development and internal validation. For external validation, one of the two independent data sets was used to assess the performance of the model in patients treated with more current regimens. Six cytogenetic abnormalities were identified as clinically relevant, and a prognostic index (PI) that was based on the parameter estimates of the multivariable Cox model was computed for all patients.
RESULTS
In all data sets, a higher PI was consistently associated with a poor survival outcome. Dependent on the validation cohorts used, hazard ratios for patients in the high-risk category for death were between six and 15 times higher than those of patients in the low-risk category. Among patients with t(4;14) or del(17p), we observed a worse survival in those classified in the high-risk category than in those in the intermediate-risk category. The PI showed good performance for discriminating between patients who died and those who survived (Harrell's concordance index greater than 70%).
CONCLUSION
The cytogenetic PI improves the classification of newly diagnosed patients with MM in the high-risk group compared with current classifications. These findings may facilitate the development of risk-adapted treatment strategies.",2019,"The PI showed good performance for discriminating between patients who died and those who survived (Harrell's concordance index greater than 70%).
","['newly diagnosed patients with MM', 'Multiple Myeloma', '1,635 patients enrolled in four trials implemented by the Intergroupe Francophone du Myélome']",['del(17p'],"['Six cytogenetic abnormalities', 'worse survival']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]",[],"[{'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1635.0,0.0274958,"The PI showed good performance for discriminating between patients who died and those who survived (Harrell's concordance index greater than 70%).
","[{'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Perrot', 'Affiliation': '1 Centre Hospitalier Régional Universitaire Nancy, Nancy, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Lauwers-Cances', 'Affiliation': '2 Centre Hospitalier Universitaire Toulouse, Toulouse, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Tournay', 'Affiliation': '2 Centre Hospitalier Universitaire Toulouse, Toulouse, France.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': '3 Centre Hospitalier Universitaire Bordeaux, Bordeaux, France.'}, {'ForeName': 'Marie-Lorraine', 'Initials': 'ML', 'LastName': 'Chretien', 'Affiliation': '4 Centre Hospitalier Universitaire Dijon, Dijon, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Royer', 'Affiliation': '5 Centre Hospitalier Universitaire Amiens, Amiens, France.'}, {'ForeName': 'Mamoun', 'Initials': 'M', 'LastName': 'Dib', 'Affiliation': '6 Centre Hospitalier Universitaire Angers, Angers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Decaux', 'Affiliation': '7 Centre Hospitalier Universitaire Rennes, Rennes, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': '8 Centre Hospitalier Universitaire Limoges, Limoges, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Belhadj', 'Affiliation': '9 Centre Hospitalier Universitaire Créteil, Créteil, France.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Brechignac', 'Affiliation': '10 Centre Hospitalier Universitaire Bobigny, Bobigny, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Fontan', 'Affiliation': '11 Centre Hospitalier Universitaire Besancon, Besançon, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Voillat', 'Affiliation': '12 Centre Hospitalier Chalon sur Saône William Morey, Chalon-sur-Saône, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Demarquette', 'Affiliation': '13 Centre Hospitalier de Dunkerque, Dunkirk, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Collet', 'Affiliation': '14 Centre Hospitalier Universitaire Saint-Étienne, Saint-Étienne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rodon', 'Affiliation': '15 Centre Hospitalier Périgueux, Périgueux, France.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Sohn', 'Affiliation': '16 Centre Hospitalier Toulon, Toulon, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lifermann', 'Affiliation': '17 Centre Hospitalier Dax, Dax, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Orsini-Piocelle', 'Affiliation': '18 Centre Hospitalier Annecy Genevois, Metz-Tessy, France.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': 'Richez', 'Affiliation': '19 Centre Hospitalier Universitaire Nice, Nice, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Mohty', 'Affiliation': '20 Centre Hospitalier Universitaire Paris, Paris, France.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Macro', 'Affiliation': '21 Centre Hospitalier Universitaire Caen Normandie, Caen, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Minvielle', 'Affiliation': '22 Centre Hospitalier Universitaire Nantes, Nantes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': '22 Centre Hospitalier Universitaire Nantes, Nantes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': '23 Centre Hospitalier Universitaire Poitiers, Poitiers, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': '24 Centre Hospitalier Régional Universitaire Lille, Lille, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': '25 Institut Universitaire du Cancer de Toulouse-Oncopole and Centre de Recherches en Cancérologie de Toulouse Institut National de la Santé et de la Recherche Médicale, Toulouse, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': '25 Institut Universitaire du Cancer de Toulouse-Oncopole and Centre de Recherches en Cancérologie de Toulouse Institut National de la Santé et de la Recherche Médicale, Toulouse, France.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Corre', 'Affiliation': '25 Institut Universitaire du Cancer de Toulouse-Oncopole and Centre de Recherches en Cancérologie de Toulouse Institut National de la Santé et de la Recherche Médicale, Toulouse, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.00776']
2810,31100038,Nivolumab Alone and With Ipilimumab in Previously Treated Metastatic Urothelial Carcinoma: CheckMate 032 Nivolumab 1 mg/kg Plus Ipilimumab 3 mg/kg Expansion Cohort Results.,"PURPOSE
CheckMate 032 is an open-label, multicohort study that includes patients with unresectable locally advanced or metastatic urothelial carcinoma (mUC) treated with nivolumab 3 mg/kg monotherapy every 2 weeks (NIVO3), nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks (NIVO3+IPI1), or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks (NIVO1+IPI3). We report on the expanded NIVO1+IPI3 cohort and extended follow-up for the NIVO3 and NIVO3+IPI1 cohorts.
METHODS
Patients with platinum-pretreated mUC were enrolled in this phase I/II multicenter study to receive NIVO3, NIVO3+IPI1, or NIVO1+IPI3 until disease progression or unacceptable toxicity. Primary end point was investigator-assessed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including duration of response.
RESULTS
Seventy-eight patients were treated with NIVO3 (minimum follow-up, 37.7 months), 104 with NIVO3+IPI1 (minimum follow-up, 38.8 months), and 92 with NIVO1+IPI3 (minimum follow-up, 7.9 months). Objective response rate was 25.6%, 26.9%, and 38.0% in the NIVO3, NIVO3+IPI1, and NIVO1+IPI3 arms, respectively. Median duration of response was more than 22 months in all arms. Grade 3 or 4 treatment-related adverse events occurred in 21 (26.9%), 32 (30.8%), and 36 (39.1%) patients treated with NIVO3, NIVO3+IPI1, and NIVO1+IPI3, respectively. Grade 5 treatment-related pneumonitis occurred in one patient each in the NIVO3 and NIVO3+IPI1 arms.
CONCLUSION
With longer follow-up, NIVO3 demonstrated sustained antitumor activity alone and in combination with ipilimumab. NIVO1+IPI3 provided the greatest antitumor activity of all regimens, with a manageable safety profile. This result not only supports additional study of NIVO1+IPI3 in mUC, but demonstrates the potential benefit of immunotherapy combinations in this disease.",2019,"Grade 5 treatment-related pneumonitis occurred in one patient each in the NIVO3 and NIVO3+IPI1 arms.
","['Patients with platinum-pretreated mUC', 'CheckMate 032', 'Seventy-eight patients were treated with NIVO3 (minimum follow-up, 37.7 months), 104 with NIVO3+IPI1 (minimum follow-up, 38.8 months), and 92 with NIVO1+IPI3 (minimum follow-up, 7.9 months', 'Previously Treated Metastatic Urothelial Carcinoma', 'patients with unresectable locally advanced or metastatic urothelial carcinoma (mUC) treated with']","['Nivolumab 1 mg/kg Plus Ipilimumab', 'nivolumab 3 mg/kg monotherapy every 2 weeks (NIVO3), nivolumab 3 mg/kg plus ipilimumab', 'Nivolumab Alone and With Ipilimumab', 'nivolumab monotherapy 3 mg/kg every 2 weeks (NIVO3+IPI1), or nivolumab 1 mg/kg plus ipilimumab', 'NIVO3, NIVO3+IPI1, or NIVO1+IPI3 until disease progression or unacceptable toxicity']","['investigator-assessed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including duration of response', 'Median duration of response', 'antitumor activity', 'Grade 5 treatment-related pneumonitis', 'adverse events', 'Objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",78.0,0.0471775,"Grade 5 treatment-related pneumonitis occurred in one patient each in the NIVO3 and NIVO3+IPI1 arms.
","[{'ForeName': 'Padmanee', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Siefker-Radtke', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': '2 Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Basso', 'Affiliation': '3 Istituto Oncologico Veneto-Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Calvo', 'Affiliation': '4 START Madrid-Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Bono', 'Affiliation': '5 Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Morse', 'Affiliation': '7 Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': '8 Istituto Nazionale Tumori-Istituto di Ricovero e Cura a Carattere Scientifico, Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Martin', 'Affiliation': '9 Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': '10 University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Rohrberg', 'Affiliation': '11 Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Mellado', 'Affiliation': ""12 Hospital Clinic of Barcelona, Institut D'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Fischer', 'Affiliation': '13 Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Meadows-Shropshire', 'Affiliation': '13 Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Abdel Saci', 'Affiliation': '13 Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Margaret K', 'Initials': 'MK', 'LastName': 'Callahan', 'Affiliation': '14 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': '14 Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00538']
2811,31229501,Specific Inhibition of the Classical Complement Pathway Prevents C3 Deposition along the Dermal-Epidermal Junction in Bullous Pemphigoid.,"Deposition of autoantibodies (α-BP180 and BP230) and complement along the dermal-epidermal-junction is a hallmark of bullous pemphigoid and was shown to be important for pathogenesis. Given the adverse effects of standard treatment (glucocorticoids, immunosuppressants), there is an unmet need for safe and effective therapies. In this phase 1 trial, we evaluated the safety and activity of BIVV009 (sutimlimab, previously TNT009), a targeted C1s inhibitor, in 10 subjects with active or past bullous pemphigoid (NCT02502903). Four weekly 60 mg/kg infusions of BIVV009 proved sufficient for inhibition of the classical complement pathway in all patients, as measured by CH50. C3c deposition along the dermal-epidermal junction was partially or completely abrogated in 4 of 5 patients, where it was present at baseline. BIVV009 was found to be safe and tolerable in this elderly population, with only mild to moderate adverse events reported (e.g., headache, fatigue). One serious adverse event (i.e., fatal cardiac decompensation) occurred at the end of the post-treatment observation period in an 84-year-old patient with a history of diabetes and heart failure, but was deemed unlikely to be related to the study drug. This trial provides the first results with a complement-targeting therapy in bullous pemphigoid, to our knowledge, and supports further studies on BIVV009's efficacy and safety in this population.",2019,"Four weekly 60 mg/kg infusions of BIVV009 proved sufficient for inhibition of the classical complement pathway in all patients, as measured by CH50.",['10 subjects with active or past bullous pemphigoid (NCT02502903'],"['standard treatment (glucocorticoids, immunosuppressants']","['safe and tolerable', 'fatal cardiac decompensation', 'C3c deposition']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0030805', 'cui_str': 'Bullous pemphigoid'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1961112', 'cui_str': 'Heart Decompensation'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}]",10.0,0.0213043,"Four weekly 60 mg/kg infusions of BIVV009 proved sufficient for inhibition of the classical complement pathway in all patients, as measured by CH50.","[{'ForeName': 'Patricia Colchete', 'Initials': 'PC', 'LastName': 'Freire', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria. Electronic address: f.patriciac@gmail.com.'}, {'ForeName': 'Cristina Herraez', 'Initials': 'CH', 'LastName': 'Muñoz', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Derhaschnig', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schoergenhofer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Firbas', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Graham C', 'Initials': 'GC', 'LastName': 'Parry', 'Affiliation': 'Complement Translational Research, Sanofi, Waltham, Massachusetts, USA.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Panicker', 'Affiliation': 'Bioverativ, Sanofi, Waltham, Massachusetts, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gilbert', 'Affiliation': 'True North Therapeutics, South San Francisco, California, USA.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stingl', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter Maximilian', 'Initials': 'PM', 'LastName': 'Heil', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.04.025']
2812,31264007,The effect of the debulking by excimer laser coronary angioplasty on long-term outcome compared with drug-coating balloon: insights from optical frequency domain imaging analysis.,"This study evaluated the 1-year efficacy of excimer laser coronary angioplasty (ELCA) before drug-coated balloon (DCB) dilatation for the treatment of in-stent restenosis (ISR). Forty consecutive patients with ISR were treated by DCB with or without the use of ELCA (ELCA plus DCB, N = 20; DCB alone, N = 20). Debulking efficiency (DE) value was defined as the neointima area on optical frequency domain imaging (OFDI) debulked by ELCA. The patients in the ELCA plus DCB group were divided into two groups (greater DE (GDE), N = 10; smaller DE (SDE), N = 10) based on the median value of DE. Thereafter, the ISR segment was prepared with a scoring balloon, followed by DCB. At follow-up, binary restenosis and target lesion revascularization (TLR) were evaluated. There were no significant differences in baseline characteristics such as age, comorbidity, and ISR type. Overall, the incidence of neoatherosclerosis in the ISR segment was 17.5%. Post-PCI, acute gain of minimum lumen diameter on quantitative coronary angiography and of minimum lumen area on OFDI was numerically higher in the GDE than in the SDE and the DCB alone group. At follow-up, the occurrences of binary restenosis and TLR in the ELCA plus DCB group were 20.0% and 10.0%; these values in the DCB alone group were 20.0% and 20.0%, respectively. Two patients from the SDE and none from the GDE developed TLR. DCB alone treatment was inferior to ELCA plus DCB treatment. However, greater ELCA debulking might be required to obtain optimal outcomes.",2020,"Post-PCI, acute gain of minimum lumen diameter on quantitative coronary angiography and of minimum lumen area on OFDI was numerically higher in the GDE than in the SDE and the DCB alone group.",['Forty consecutive patients with ISR'],"['DCB', 'excimer laser coronary angioplasty (ELCA) before drug-coated balloon (DCB) dilatation', 'drug-coating balloon', 'ELCA (ELCA plus DCB', 'ELCA plus DCB', 'excimer laser coronary angioplasty']","['OFDI', 'binary restenosis and target lesion revascularization (TLR', 'Debulking efficiency (DE) value', 'TLR', 'occurrences of binary restenosis and TLR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0392265', 'cui_str': 'Excimer laser device'}, {'cui': 'C0002997', 'cui_str': 'Angioplasty, Coronary Balloon'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0304222', 'cui_str': 'Drug coating'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",40.0,0.0174443,"Post-PCI, acute gain of minimum lumen diameter on quantitative coronary angiography and of minimum lumen area on OFDI was numerically higher in the GDE than in the SDE and the DCB alone group.","[{'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Cardiology, Tachikawa General Hospital, 561-1 Jyojyomachi Aza Yauchi, Nagaoka City, Japan. kirotaro19731013@yahoo.co.jp.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Tsuchida', 'Affiliation': 'Niigata Municipal Hospital, Niigata, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Yuasa', 'Affiliation': 'Cardiology, Tachikawa General Hospital, 561-1 Jyojyomachi Aza Yauchi, Nagaoka City, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Taya', 'Affiliation': 'Cardiology, Tachikawa General Hospital, 561-1 Jyojyomachi Aza Yauchi, Nagaoka City, Japan.'}, {'ForeName': 'Tomoyasu', 'Initials': 'T', 'LastName': 'Koshikawa', 'Affiliation': 'Cardiology, Tachikawa General Hospital, 561-1 Jyojyomachi Aza Yauchi, Nagaoka City, Japan.'}, {'ForeName': 'Komei', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Niigata Municipal Hospital, Niigata, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Cardiology, Tachikawa General Hospital, 561-1 Jyojyomachi Aza Yauchi, Nagaoka City, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Cardiology, Tachikawa General Hospital, 561-1 Jyojyomachi Aza Yauchi, Nagaoka City, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Cardiology, Tachikawa General Hospital, 561-1 Jyojyomachi Aza Yauchi, Nagaoka City, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Okabe', 'Affiliation': 'Cardiology, Tachikawa General Hospital, 561-1 Jyojyomachi Aza Yauchi, Nagaoka City, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Niigata Municipal Hospital, Niigata, Japan.'}, {'ForeName': 'Yoshifusa', 'Initials': 'Y', 'LastName': 'Aizawa', 'Affiliation': 'Cardiology, Tachikawa General Hospital, 561-1 Jyojyomachi Aza Yauchi, Nagaoka City, Japan.'}]",Lasers in medical science,['10.1007/s10103-019-02833-1']
2813,31353364,Patterns of response with talimogene laherparepvec in combination with ipilimumab or ipilimumab alone in metastatic unresectable melanoma.,"Talimogene laherparepvec (T-VEC) has demonstrated efficacy for unresectable melanoma. We explored response patterns from a phase 2 study evaluating patients with unresectable stage IIIB-IVM1c malignant melanoma who received T-VEC plus ipilimumab or ipilimumab alone. Patients with objective response per modified irRC were evaluated for pseudo-progression (single ≥25% increase in tumour burden before response). Patients without pseudo-progression were classified by whether they responded within or after 6 months of treatment start; those with pseudo-progression were classified by whether pseudo-progression was due to increase in existing lesions or development of new lesions. Overall, 39% (n = 38/98) in the combination arm and 18% (n = 18/100) in the ipilimumab arm had an objective response. Eight responders (combination, n = 7 [18.4%]; ipilimumab, n = 1 [5.6%]) had pseudo-progression; most occurred by week 12 and were caused by an increase in existing lesions. These data reinforce use of T-VEC through initial progression when combined with checkpoint inhibitors.Trial Registration NCT01740297 (ClinicalTrials.gov; date of registration, December 4, 2012); 2012-000307-32 (ClinicalTrialsRegister.eu; date of registration, May 13, 2014).",2019,Patients with objective response per modified irRC were evaluated for pseudo-progression (single ≥25% increase in tumour burden before response).,"['metastatic unresectable melanoma', 'patients with unresectable stage IIIB-IVM1c malignant melanoma who received']","['ipilimumab or ipilimumab alone', 'Talimogene laherparepvec (T-VEC', 'T-VEC plus ipilimumab or ipilimumab alone']","['objective response', 'pseudo-progression']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1831828', 'cui_str': 'talimogene laherparepvec'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.159882,Patients with objective response per modified irRC were evaluated for pseudo-progression (single ≥25% increase in tumour burden before response).,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chesney', 'Affiliation': 'James Graham Brown Cancer Center, University of Louisville, Louisville, KY, USA. jason.chesney@louisville.edu.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Puzanov', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Collichio', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Milhem', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University of Kiel, Kiel, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Parminder', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Mehnert', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}]",British journal of cancer,['10.1038/s41416-019-0530-6']
2814,32504574,"Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials.","BACKGROUND
In the primary week-48 analyses of two phase 3 studies, coformulated bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to a dolutegravir-containing regimen in treatment-naive people with HIV. We report week-144 efficacy and safety results from these studies.
METHODS
We did two double-blind, active-controlled studies (now in open-label extension phase). Study 1 randomly assigned (1:1) HLA-B*5701-negative adults without hepatitis B virus co-infection to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg once daily. Study 2 randomly assigned (1:1) adults to bictegravir, emtricitabine, and tenofovir alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and tenofovir alafenamide 25 mg. We previously reported non-inferiority at the primary endpoint. Here, we report the week-144 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 144, by US Food and Drug Administration Snapshot algorithm, analysed in the same manner. These studies were registered with ClinicalTrials.gov, NCT02607930 and NCT02607956.
FINDINGS
629 participants were randomly assigned and treated in study 1 (314 to bictegravir, emtricitabine, and tenofovir alafenamide, and 315 to dolutegravir, abacavir, and lamivudine) and 645 in study 2 (327 to bictegravir, emtricitabine, and tenofovir alafenamide, 325 to dolutegravir, emtricitabine, tenofovir alafenamide). At week 144, bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to both dolutegravir-containing regimens for efficacy. In study 1, 256 (82%) of 314 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and tenofovir alafenamide group and 265 (84%) of 315 in the dolutegravir, abacavir, and lamivudine group (difference -2·6%, 95% CI -8·5 to 3·4). In study 2, 262 (82%) of 320 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and tenofovir alafenamide group and 273 (84%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (difference -1·9%, -7·8 to 3·9). In both studies, no participant had treatment-emergent resistance to study drugs up to week 144. All treatment regimens were well tolerated with additional exposure. Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2). In study 1, statistically significant differences were observed in median changes from baseline in fasting total cholesterol (14 mg/dL vs 10 mg/dL; p=0·034), direct LDL (21 mg/dL vs 14 mg/dL; p=0·004), and total cholesterol to HDL ratio (-0·1 vs -0·3; p=0·007) at week 144; no differences were observed between groups in study 2. Weight gain was seen across all treatment groups in both studies, with no differences in median changes from baseline in weight at week 144 for either study.
INTERPRETATION
These long-term data support the use of bictegravir, emtricitabine, and tenofovir alafenamide as a safe, well tolerated, and durable treatment for people with HIV, with no emergent resistance.
FUNDING
Gilead Sciences.",2020,"Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2).","['people with HIV, with no emergent resistance', 'HLA-B*5701-negative adults without hepatitis B virus co-infection', '629 participants were randomly assigned and treated in study 1 (314 to']","['alafenamide', 'coformulated bictegravir, emtricitabine, and tenofovir alafenamide', 'direct LDL', 'bictegravir, emtricitabine, and tenofovir alafenamide, 325 to dolutegravir, emtricitabine, tenofovir alafenamide', 'tenofovir alafenamide', 'bictegravir, emtricitabine, and tenofovir', 'bictegravir, emtricitabine, and tenofovir alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and tenofovir alafenamide 25 mg', 'Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens', 'bictegravir, emtricitabine, and tenofovir alafenamide', 'coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine', 'lamivudine', 'bictegravir, emtricitabine, and tenofovir alafenamide, and 315 to dolutegravir, abacavir, and lamivudine']","['fasting total cholesterol', 'plasma HIV-1 RNA less', 'total cholesterol to HDL ratio', 'Weight gain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0440557', 'cui_str': 'B*5701'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1331249', 'cui_str': 'emtricitabine 200 MG'}, {'cui': 'C4083965', 'cui_str': 'tenofovir alafenamide 25 MG'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4551053', 'cui_str': 'bictegravir 50 MG'}, {'cui': 'C1629814', 'cui_str': 'abacavir 600 MG'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",629.0,0.25769,"Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2).","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK; Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London, UK.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Infectious Diseases Unit, Hospital Universitario La Paz, IdiPaz Madrid, Spain.'}, {'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Martorell', 'Affiliation': 'The Research Institute, Springfield, MA, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Stephens', 'Affiliation': 'Department of Internal Medicine, Mercer University School of Medicine, Macon, GA, USA.'}, {'ForeName': 'Hans-Jurgen', 'Initials': 'HJ', 'LastName': 'Stellbrink', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wohl', 'Affiliation': 'Department of Medicine, Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'Unit of HIV-related Diseases and Experimental Therapies, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': 'Infectious Disease Department, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hagins', 'Affiliation': 'Georgia Department of Public Health, Coastal Health District, Chatham Care Center, Savannah, GA, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Flamm', 'Affiliation': 'Department of Adult and Family Medicine, Kaiser Permanente Medical Group, Sacramento, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Elton John Centre, Royal Sussex County Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Hailin', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Acosta', 'Affiliation': 'Department of Virology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA. Electronic address: sean.collins@gilead.com.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30099-0']
2815,32504575,"Population uptake of HIV testing, treatment, viral suppression, and male circumcision following a community-based intervention in Botswana (Ya Tsie/BCPP): a cluster-randomised trial.","BACKGROUND
In settings with high HIV prevalence and treatment coverage, such as Botswana, it is unknown whether uptake of HIV prevention and treatment interventions can be increased further. We sought to determine whether a community-based intervention to identify and rapidly treat people living with HIV, and support male circumcision could increase population levels of HIV diagnosis, treatment, viral suppression, and male circumcision in Botswana.
METHODS
The Ya Tsie Botswana Combination Prevention Project study was a pair-matched cluster-randomised trial done in 30 communities across Botswana done from Oct 30, 2013, to June 30, 2018. 15 communities were randomly assigned to receive HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care. The first primary endpoint of HIV incidence has already been reported. In this Article, we report findings for the second primary endpoint of population uptake of HIV prevention services, as measured by proportion of people known to be HIV-positive or tested HIV-negative in the preceding 12 months; proportion of people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised. A longitudinal cohort of residents aged 16-64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates. Differences in intervention uptake over time by randomisation group were tested via paired Student's t test. The study has been completed and is registered with ClinicalTrials.gov (NCT01965470).
FINDINGS
In the six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015. In the same communities, 10 791 (86%) of 12 489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities). At study end, in intervention communities, 1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities. After accounting for baseline differences, at study end the proportion of people living with HIV who were diagnosed was significantly higher in intervention communities (absolute increase of 9% to 93%) compared with standard-of-care communities (absolute increase of 2% to 88%; prevalence ratio [PR] 1·08 [95% CI 1·02-1·14], p=0·032). Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029).
INTERPRETATION
It is possible to achieve very high population levels of HIV testing and treatment in a high-prevalence setting. Maintaining these coverage levels over the next decade could substantially reduce HIV transmission and potentially eliminate the epidemic in these areas.
FUNDING
US President's Emergency Plan for AIDS Relief through the Centers for Disease Control and Prevention.",2020,"Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029).
","['In the same communities, 10\u2008791 (86%) of 12\u2008489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities', 'residents aged 16-64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates', '15 communities', 'people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised', '30 communities across Botswana done from Oct 30, 2013, to June 30, 2018', 'six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015', '1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities']","['community-based intervention in Botswana (Ya Tsie/BCPP', 'HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care']","['Population levels of ART, viral suppression, and male circumcision']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}]",15.0,0.247072,"Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029).
","[{'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Wirth', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA. Electronic address: kathleen.wirth@gmail.com.'}, {'ForeName': 'Tendani', 'Initials': 'T', 'LastName': 'Gaolathe', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Pretorius Holme', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mompati', 'Initials': 'M', 'LastName': 'Mmalane', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Kadima', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Unoda', 'Initials': 'U', 'LastName': 'Chakalisa', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kutlo', 'Initials': 'K', 'LastName': 'Manyake', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Atang', 'Initials': 'A', 'LastName': 'Matildah Mbikiwa', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Selebaleng V', 'Initials': 'SV', 'LastName': 'Simon', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Letlhogile', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kutlwano', 'Initials': 'K', 'LastName': 'Mukokomani', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Widenfelt', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Sikhulile', 'Initials': 'S', 'LastName': 'Moyo', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'Bennett Statistical Consulting, Ballston Lake, NY, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Leidner', 'Affiliation': 'Goodtables Data Consulting, Norman, Oklahoma, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Powis', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Ministry of Health and Wellness, Botswana, Gaborone, Botswana.'}, {'ForeName': 'Mary Grace', 'Initials': 'MG', 'LastName': 'Alwano', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Dryden-Peterson', 'Affiliation': ""Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Coulson', 'Initials': 'C', 'LastName': 'Kgathi', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Raizes', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Abrams', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Block', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA; Intellectual Concepts, Atlanta, GA, USA.'}, {'ForeName': 'Baraedi', 'Initials': 'B', 'LastName': 'Sento', 'Affiliation': 'Tebelopele Voluntary Counseling and Testing Center, Gaborone, Botswana.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Novitsky', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Shenaaz', 'Initials': 'S', 'LastName': 'El-Halabi', 'Affiliation': 'Ministry of Health and Wellness, Botswana, Gaborone, Botswana.'}, {'ForeName': 'Tafireyi', 'Initials': 'T', 'LastName': 'Marukutira', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mills', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Sexton', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Pals', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Shapiro', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Lei', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'DeGruttola', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Essex', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Tchetgen Tchetgen', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA; Department of Statistics, The Wharton School at the University of Pennsylvania, Philadelphia, PA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30103-X']
2816,32504593,Low-dose fractionated radiation with induction docetaxel and cisplatin followed by concurrent cisplatin and radiation therapy in locally advanced nasopharyngeal cancer: A randomized phase II-III trial.,"OBJECTIVE/BACKGROUND
To evaluate the efficacy and outcome of adding low-dose fractionated radiotherapy (LDFRT) to induction chemotherapy plus concurrent chemoradiation in locally advanced nasopharyngeal carcinoma (LANPC).
METHODS
A single-institute, phase II-III, prospectively controlled randomized clinical trial was performed at King Faisal Specialist Hospital and Research Centre. Patients aged 18-70 years with WHO type II and III, stage III-IVB nasopharyngeal carcinoma, Eastern Cooperative Oncology Group performance score of 0-2, with adequate hematological, renal, and hepatic function were eligible. In total, 108 patients were enrolled in this trial. All patients received two cycles of induction docetaxel and cisplatin (75 mg/m 2 each) chemotherapy on Days 1 and 22, followed by concurrent chemoradiation therapy. Radiation therapy consisted of 70 Gy in 33 fractions, with concurrent cisplatin 25 mg/m 2 for 4 days on Days 43 and 64. Patients were randomly assigned to either adding LDFRT (0.5 Gy twice daily 6 hours apart for 2 days) to induction chemotherapy in the experimental arm (54 patients) or induction chemotherapy alone in the control arm (54 patients).
RESULTS
There was no significant difference in the post-induction response rates (RRs) or in toxicity between the two treatment arms. The 3-year overall survival (OS), locoregional control (LRC), and distant metastases-free survival (DMFS) rates for experimental arm and control arm were 94% versus 93% (p = .8), 84.8% versus 87.5% (p = .58), and 84.1% versus 91.6% (p = .25), respectively.
CONCLUSION
The results showed no benefit from adding LDFRT to induction chemotherapy in terms of RR, OS, LRC, and DMFS.",2020,There was no significant difference in the post-induction response rates (RRs) or in toxicity between the two treatment arms.,"['Patients aged 18-70\u202fyears with WHO type II and III, stage III-IVB nasopharyngeal carcinoma, Eastern Cooperative Oncology Group performance score of 0-2, with adequate hematological, renal, and hepatic function were eligible', '108 patients were enrolled in this trial', 'A single-institute, phase II-III, prospectively controlled randomized clinical trial was performed at King Faisal Specialist Hospital and Research Centre', 'locally advanced nasopharyngeal carcinoma (LANPC', 'locally advanced nasopharyngeal cancer']","['Low-dose fractionated radiation with induction docetaxel and cisplatin followed by concurrent cisplatin and radiation therapy', 'LDFRT', 'concurrent cisplatin', 'induction chemotherapy alone', 'induction chemotherapy plus concurrent chemoradiation', 'induction chemotherapy', 'induction docetaxel and cisplatin', 'low-dose fractionated radiotherapy (LDFRT']","['RR, OS, LRC, and DMFS', '3-year overall survival (OS), locoregional control (LRC), and distant metastases-free survival (DMFS) rates', 'post-induction response rates (RRs) or in toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0153392', 'cui_str': 'Malignant tumor of nasopharynx'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",108.0,0.058704,There was no significant difference in the post-induction response rates (RRs) or in toxicity between the two treatment arms.,"[{'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Al-Rajhi', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia. Electronic address: nrajhi@kfshrc.edu.sa.'}, {'ForeName': 'Ehab M', 'Initials': 'EM', 'LastName': 'Khalil', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Shoaib', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Soudy', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'AlGhazi', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Doha M', 'Initials': 'DM', 'LastName': 'Fatani', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Memon', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Moheieldin', 'Initials': 'M', 'LastName': 'Abouzied', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Khafaga', 'Affiliation': 'King Faisal Hospital and Research Centre, Riyadh, Saudi Arabia.'}]",Hematology/oncology and stem cell therapy,['10.1016/j.hemonc.2020.05.005']
2817,32504611,Does Tweeting Improve Citations? One-Year Results from the TSSMN Prospective Randomized Trial.,"BACKGROUND
The Thoracic Surgery Social Media Network (TSSMN) is a collaborative effort of leading journals in cardiothoracic surgery to highlight publications via social media. This study aims to evaluate the 1-year results of a prospective randomized social media trial to determine the effect of tweeting on subsequent citations and non-traditional bibliometrics.
METHODS
A total of 112 representative original articles were randomized 1:1 to be tweeted via TSSMN or a control (non-tweeted) group. Measured endpoints included citations at 1-year compared to baseline, as well as article-level metrics (Altmetric score) and Twitter analytics. Independent predictors of citations were identified through univariable and multivariable regression analyses.
RESULTS
When compared to control articles, tweeted articles achieved significantly greater increase in Altmetric scores (Tweeted 9.4±5.8 vs. Non-Tweeted 1.0±1.8, p<0.001), Altmetric score percentiles relative to articles of similar age from each respective journal (Tweeted 76.0±9.1%ile vs. Non-Tweeted 13.8±22.7%ile, p<0.001), with greater change in citations at 1 year (Tweeted +3.1±2.4 vs. Non-Tweeted +0.7±1.3, p<0.001). Multivariable analysis showed that independent predictors of citations were randomization to tweeting (OR 9.50; 95%CI 3.30-27.35, p<0.001), Altmetric score (OR 1.32; 95%CI 1.15-1.50, p<0.001), open-access status (OR 1.56; 95%CI 1.21-1.78, p<0.001), and exposure to a larger number of Twitter followers as quantified by impressions (OR 1.30, 95%CI 1.10-1.49, p<0.001).
CONCLUSIONS
One-year follow-up of this TSSMN prospective randomized trial importantly demonstrates that tweeting results in significantly more article citations over time, highlighting the durable scholarly impact of social media activity.",2020,"Multivariable analysis showed that independent predictors of citations were randomization to tweeting (OR 9.50; 95%CI 3.30-27.35, p<0.001), Altmetric score (OR 1.32; 95%CI 1.15-1.50, p<0.001), open-access status (OR 1.56; 95%CI 1.21-1.78, p<0.001), and exposure to a larger number of Twitter followers as quantified by impressions (OR 1.30, 95%CI 1.10-1.49, p<0.001).
",['A total of 112 representative original articles'],"['Thoracic Surgery Social Media Network (TSSMN', 'TSSMN']","['Altmetric scores', 'Altmetric score', 'article-level metrics (Altmetric score) and Twitter analytics']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205313', 'cui_str': 'Original'}]","[{'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",112.0,0.101332,"Multivariable analysis showed that independent predictors of citations were randomization to tweeting (OR 9.50; 95%CI 3.30-27.35, p<0.001), Altmetric score (OR 1.32; 95%CI 1.15-1.50, p<0.001), open-access status (OR 1.56; 95%CI 1.21-1.78, p<0.001), and exposure to a larger number of Twitter followers as quantified by impressions (OR 1.30, 95%CI 1.10-1.49, p<0.001).
","[{'ForeName': 'Jessica G Y', 'Initials': 'JGY', 'LastName': 'Luc', 'Affiliation': 'Division of Cardiovascular Surgery, Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Archer', 'Affiliation': 'Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Rakesh C', 'Initials': 'RC', 'LastName': 'Arora', 'Affiliation': 'Section of Cardiac Surgery, Department of Surgery, Max Rady College of Medicine, University of Manitoba, St. Boniface Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Bender', 'Affiliation': 'Department of Cardiothoracic Surgery, Stanford University, Palo Alto, California, USA.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Blitz', 'Affiliation': 'Division of Cardiac Surgery, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Cooke', 'Affiliation': 'Section of General Thoracic Surgery, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Tamara Ni', 'Initials': 'TN', 'LastName': 'Hlci', 'Affiliation': 'Department of Cardiothoracic Surgery, Morriston Hospital, ABMU, Swansea, United Kingdom.'}, {'ForeName': 'Biniam', 'Initials': 'B', 'LastName': 'Kidane', 'Affiliation': 'Section of Thoracic Surgery, Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Maral', 'Initials': 'M', 'LastName': 'Ouzounian', 'Affiliation': 'Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Varghese', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Mara B', 'Initials': 'MB', 'LastName': 'Antonoff', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, UT MD Anderson Cancer Center, Houston, TX, USA. Electronic address: mbantonoff@mdanderson.org.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.04.065']
2818,32504694,Forty-eight-hour fasting declines mental flexibility but improves balance in overweight and obese older women.,"The purpose of this study was to investigate the effects of a 48-h fast on evoked stress, mood, and cognitive and motor functions in overweight and obese older women. Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years were tested under two randomly allocated conditions: 48-h zero-calorie diet with water provided ad libitum and 48-h usual diet. Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance were evaluated before and after each diet. Fasting increased (P < 0.05) cortisol levels, whereas no changes were observed in heart rate and its variability. Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests. Thus, although a 48-h fast resulted in greater hypothalamic-pituitary-adrenal axis activity in overweight and obese older women, autonomic nervous system activity was not affected. Fasting increased fatigue and decreased mental flexibility, but improved balance.",2020,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","['Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years', 'overweight and obese older women']",['48-h zero-calorie diet with water provided ad libitum and 48-h usual diet'],"['evoked stress, mood, and cognitive and motor functions', 'Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance', 'reaction time', 'Fasting increased fatigue and decreased mental flexibility', 'autonomic nervous system activity', 'cortisol levels', 'heart rate and its variability', 'pursuit tracking and finger tapping tests', 'hypothalamic-pituitary-adrenal axis activity', 'Fasting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]",,0.0141728,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University. Electronic address: rima.solianik@lsu.lt.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Drozdova-Statkevičienė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Sujeta', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112995']
2819,32504701,Propofol compared with bolus and titrated midazolam for sedation in outpatient colonoscopy: a prospective randomized double-blind study.,"BACKGROUND AND AIMS
The safest and most efficient method of sedation for outpatient colonoscopy remains unclear. The study aimed to compare the efficiency and safety of bolus administration of midazolam compared with titrated administration and propofol administration for patients undergoing outpatient colonoscopy.
METHODS
We randomly divided patients undergoing colonoscopy into the propofol group, bolus midazolam group, and titrated midazolam group. We compared total procedure time, induction time, recovery time, and discharge time between the 3 groups. We also compared patient satisfaction and the incidence of adverse events.
RESULTS
In total, 267 patients (89 in each study group) were enrolled during the study period. Patients in the propofol group had a shorter total procedure time (39.5 vs 59.4 vs 58.1 min; P < .001), induction time (4.6 vs 6.3 vs 7.6 min; P < .001), recovery time (11.5 vs 29.5 vs 29.2 min; P < .001), and discharge time (20.6 vs 34.9 vs 34.7 min; P < .001) than patients in the bolus midazolam group and titrated midazolam group. Patients in the propofol group reported higher degrees of satisfaction than patients in the bolus or titrated midazolam plus meperidine groups (9.9 vs 9.6 vs 9.6; P = 0.007, 4.9 vs 4.7 vs 4.8; P = .008). Adverse events were not significantly different between groups.
CONCLUSIONS
In this randomized trial, propofol was superior to bolus or titrated midazolam in terms of endoscopy unit efficiency and patient satisfaction during outpatient colonoscopy. (International Clinical Trials Registry Platform number: KCT0002805.).",2020,"Patients in the propofol group reported higher degrees of satisfaction than patients in the bolus or titrated midazolam plus meperidine groups (9.9 vs 9.6 vs 9.6; P = 0.007, 4.9 vs 4.7 vs 4.8; P = .008).","['We randomly divided patients undergoing', '267 patients (89 in each study group) were enrolled during the study period', 'patients undergoing outpatient colonoscopy', 'outpatient colonoscopy']","['bolus and titrated midazolam', 'midazolam plus meperidine', 'midazolam', 'Propofol', 'colonoscopy into the propofol group, bolus midazolam', 'propofol']","['discharge time', 'Adverse events', 'efficiency and safety', 'recovery time', 'induction time', 'higher degrees of satisfaction', 'shorter total procedure time', 'total procedure time, induction time, recovery time, and discharge time']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",267.0,0.230232,"Patients in the propofol group reported higher degrees of satisfaction than patients in the bolus or titrated midazolam plus meperidine groups (9.9 vs 9.6 vs 9.6; P = 0.007, 4.9 vs 4.7 vs 4.8; P = .008).","[{'ForeName': 'Dae Bum', 'Initials': 'DB', 'LastName': 'Kim', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Joon Sung', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. Electronic address: kijoons@catholic.ac.kr.""}, {'ForeName': 'Cheal Wung', 'Initials': 'CW', 'LastName': 'Huh', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Dae Won', 'Initials': 'DW', 'LastName': 'Ma', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Jeong-Seon', 'Initials': 'JS', 'LastName': 'Ji', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Byung-Wook', 'Initials': 'BW', 'LastName': 'Kim', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Hwang', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.045']
2820,32504715,Rehabilitation posture has no effect on the outcome of arthroscopically treated acromioclavicular dislocation.,"PURPOSE
We aimed to assess the effect of the patient's posture (erect or supine) during the rehabilitation sessions on the pain, function and the CC (Coracoclavicular) distance after arthroscopic treatment of acromioclavicular (AC) joint dislocation.
METHODS
Sixty patients with acute AC dislocation injury types, III and V, were randomly allocated into two groups according to their posture during the rehabilitation phase (Supine Rehabilitation Group; SRG, or Erect Rehabilitation Group; ERG). Arthroscopic stabilization with a suspensory fixation device was used for all the patients. Visual Analogue Scale (VAS) was assessed on the first postoperative day, after 1, 3 and 6 months postoperatively. Constant-Murley Score (CMS) was recorded preoperatively, after 3, 6, 12 and 24 months postoperatively. The coracoclavicular (CC) distance was assessed preoperatively, on the first postoperative day, after 6, 12 and 24 months postoperatively.
RESULTS
No significant differences were found between the two groups in terms of the VAS, CMS scores, and CC distance changes. A significant improvement over the follow-up phase was identified in the VAS and CMS of both groups. The CC distance in both groups was significantly reduced from the preoperative (29.34 mm in the ERG and 28.65 mm in the SRG) to the first postoperative day (10.44 mm in the ERG and 10.11 mm in the SRG). However, a statistically significant rewidening in the CC distance occurred within the first six months after surgery (13.55 mm for the ERG and 13.50 mm for the SRG) and 12 months (15.51 for the ERG and 15.80 for the SRG, P<0.001).
CONCLUSION
The patient's posture during early postoperative rehabilitation does not affect the coracoclavicular distance changes.",2020,"No significant differences were found between the two groups in terms of the VAS, CMS scores, and CC distance changes.","['Sixty patients with acute AC dislocation injury types, III and V']","['Arthroscopic stabilization with a suspensory fixation device', ""patient's posture (erect or supine"", 'posture during the rehabilitation phase (Supine Rehabilitation Group; SRG, or Erect Rehabilitation Group; ERG']","['coracoclavicular (CC) distance', 'Constant-Murley Score (CMS', 'CC distance', 'Visual Analogue Scale (VAS', 'coracoclavicular distance changes', 'VAS, CMS scores, and CC distance changes', 'pain, function and the CC (Coracoclavicular) distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0449499', 'cui_str': 'Type of injury'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0441254', 'cui_str': 'Fixation device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",60.0,0.018762,"No significant differences were found between the two groups in terms of the VAS, CMS scores, and CC distance changes.","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Orthopedic department- Faculty of Medicine- Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Gameel', 'Affiliation': 'Orthopedic department- Faculty of Medicine- Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdelghafar', 'Affiliation': 'Orthopedic department- Faculty of Medicine- Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Tarek Mohamed', 'Initials': 'TM', 'LastName': 'Ghandour', 'Affiliation': 'Orthopedic department- Faculty of Medicine- Ain Shams University, Cairo, Egypt. Electronic address: tarekghndr@yahoo.com.'}, {'ForeName': 'Begad M Samy', 'Initials': 'BMS', 'LastName': 'Abbas', 'Affiliation': 'Physical medicine, Rheumatology and Rehabilitation department- Faculty of Medicine- Ain Shams University,cairo,Egypt.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.043']
2821,32504862,Comparative study of mizoribine and mycophenolate mofetil combined with a calcineurin inhibitor-based immunosuppressive regimen in patients with alternative donor hematopoietic cell transplantation: Mizoribine vs mycophenolate mofetil for hematopoietic cell transplantation.,"BACKGROUND AND OBJECTIVE
Cytomegalovirus (CMV) infection and graft versus host disease (GvHD) remain the major causes of nonrelapse mortality (NRM) in patients following alternative donor HCT. Mizoribine (MZR) showed an anti-CMV effect in addition to its immunosuppressive effect in patients with renal transplantation. In this study, we aimed to evaluate the efficacy and safety of MZR combined with CNIs as a method of prophylactic immunosuppression in recipients following alternative donor HCT.
METHODS
Eighty patients were enrolled in the study and randomized to the MZR (n = 40) and MMF (n = 40) cohorts before transplant conditioning. Analyses involved a comparison of the outcomes between the two cohorts as well as risk analyses of early NRM and severe CMV infection.
RESULTS
In contrast to MMF, MZR resulted in a lower but statistically nonsignificant median CMV DNA peak load (p = 0.075), significantly fewer episodes of persistent/refractory infection (OR = 0.12), and a lower failure rate of CMV treatment (OR = 0.82), but the occurrence of hyperuricemia was significantly increased (OR = 2.75). The transplant efficacy was comparable between the two cohorts regarding engraftment, the development of secondary poor graft function (sPGF) and GvHD, and the estimated OS and PFS. The 1-y NRM of the MZR cohort was not different from that of the MMF cohort, while the rate of 1-y NRM caused by viral infections was reduced in the MZR cohort and was of borderline statistical significance (p = 0.05). In the multivariate analysis, lower doses of CD34+ cells in grafts (HR = 3.65) and persistent/refractory CMV infections (vs w/o CMV infection: HR = 7.31; vs CMV infection that was not persistent/refractory: HR = 4.46) were predictors of increased 1-y NRM. The use of MMF (vs MZR cohort: OR = 11.54) and grade Ⅱ to Ⅳ acute GvHD (OR = 15.32) were independent risk factors for developing persistent/refractory CMV infections.
CONCLUSIONS
When combined with CNIs, MZR functioned well in terms of both immunosuppression and the reduction of the severity of CMV infection; however, further studies are warranted to verify whether it could be used as a potential immunosuppressant for alternative donor HCT.",2020,"The transplant efficacy was comparable between the two cohorts regarding engraftment, the development of secondary poor graft function (sPGF) and GvHD, and the estimated OS and PFS.","['patients with renal transplantation', 'recipients following alternative donor HCT', 'patients following alternative donor HCT', 'for hematopoietic cell transplantation', 'patients with alternative donor hematopoietic cell transplantation', 'Eighty patients were enrolled in the study and randomized to the MZR (n\u202f=\u202f40) and MMF (n\u202f=\u202f40) cohorts before transplant conditioning']","['mizoribine and mycophenolate mofetil combined with a calcineurin inhibitor-based immunosuppressive regimen', 'Mizoribine vs mycophenolate mofetil', 'Mizoribine (MZR', 'MMF', 'MZR combined with CNIs']","['risk analyses of early NRM and severe CMV infection', 'episodes of persistent/refractory infection', 'median CMV DNA peak load', 'failure rate of CMV treatment', 'transplant efficacy', 'refractory CMV infections', 'rate of 1-y NRM caused by viral infections', 'efficacy and safety', 'occurrence of hyperuricemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0128608', 'cui_str': 'Mizoribine'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0376450', 'cui_str': 'Conditioning, Transplantation'}]","[{'cui': 'C0128608', 'cui_str': 'Mizoribine'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0369083', 'cui_str': 'Cytomegalovirus DNA'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}]",80.0,0.0245141,"The transplant efficacy was comparable between the two cohorts regarding engraftment, the development of secondary poor graft function (sPGF) and GvHD, and the estimated OS and PFS.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Mingzhe', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Rongli', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Aiming', 'Initials': 'A', 'LastName': 'Pang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhai', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Erlie', 'Initials': 'E', 'LastName': 'Jiang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Sizhou', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China. Electronic address: zhangli@ihcams.ac.cn.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.05.022']
2822,32504895,Patterns of daytime physical activity in patients with chronic fatigue syndrome.,"OBJECTIVES
To classify patients with chronic fatigue syndrome (CFS) by pattern of physical activity and determine the clinical associations of each type.
METHODS
579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy: a randomised Evaluation) trial wore an Actiwatch (accelerometer) for between 3 and 7 days before any trial treatments, which provided a measure of physical activity. Participants' activity was categorised into one of four patterns (pervasively inactive, pervasively active, boom and bust, or indeterminate) primarily using a priori definitions of activity. Clinical associations were sought with each group using an exploratory logistic regression with the indeterminate activity group being the reference group.
RESULTS
124 (21%) of the participants were classified as pervasively inactive, 65 (11%) as pervasively active, 172 (30%) showed a 'boom and bust' pattern of activity, and 218 (38%) had an indeterminate pattern. Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
CONCLUSION
We were able to classify patients with CFS into groups by their daytime activity pattern. The different patterns of activity were associated with important clinical variables, suggesting that they might be helpful in determining prognosis and targeting treatments. These associations need replication.",2020,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
","['patients with chronic fatigue syndrome', '579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy', 'patients with chronic fatigue syndrome (CFS']",[],"['sleep disturbance', 'daytime physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],"[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",641.0,0.0298142,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beynon', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, King's College London, Weston Education Centre, London, UK. Electronic address: Trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'White', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110154']
2823,32505019,"Indentation marks, skin temperature and comfort of two cervical collars: A single-blinded randomized controlled trial in healthy volunteers.","BACKGROUND
Collar-related pressure ulcers (CRPU) are a problem in trauma patients with a suspicion of cervical cord injury patients. Indentation marks (IM), skin temperature (T sk ) and comfort could play a role in the development of CRPU. Two comparable cervical collars are the Stifneck® and Philadelphia®. However, the differences between them remain unclear.
AIM
To determine and compare occurrence and severity of IM, T sk and comfort of the Stifneck® and Philadelphia® in immobilized healthy adults.
METHODS
This single-blinded randomized controlled trial compared two groups of immobilized participants in supine position for 20 min.
RESULTS
All participants (n = 60) generated IM in at least one location in the observed area. Total occurrence was higher in the Stifneck®-group (n = 95 versus n = 69; p = .002). T sk increased significantly with 1.0 °C in the Stifneck®-group and 1.3 °C in the Philadelphia®-group (p = .024). Comfort was rated 3 on a scale of 5 (p = .506).
CONCLUSION
The occurrence of IM in both groups was high. In comparison to the Stifneck®, fewer and less severe IM were observed from the Philadelphia®. The T sk increased significantly with both collars; however, no clinical difference in increase of T sk between them was found. The results emphasize the need for a better design of cervical collars regarding CRPU.",2020,Total occurrence was higher in the Stifneck®-group,"['immobilized healthy adults', 'trauma patients with a suspicion of cervical cord injury patients', 'healthy volunteers', 'participants in supine position for 20\xa0min']","['immobilized', 'Collar-related pressure ulcers (CRPU']","['Indentation marks (IM), skin temperature (T sk ) and comfort', 'T sk', 'severe IM', 'Total occurrence', 'Indentation marks, skin temperature and comfort of two cervical collars']","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0457846', 'cui_str': 'Segment of cervical spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]","[{'cui': 'C0332467', 'cui_str': 'Indentation'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}]",,0.152707,Total occurrence was higher in the Stifneck®-group,"[{'ForeName': 'J P L', 'Initials': 'JPL', 'LastName': 'Leenen', 'Affiliation': 'Department of Surgery, Isala, Dr. van Heesweg 2, 8025 AB Zwolle, The Netherlands. Electronic address: j.p.l.leenen@isala.nl.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Ham', 'Affiliation': 'Emergency Department, University Medical Center Utrecht, University of Applied Science, Institute of Nursing Studies, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: w.h.ham@umcutrecht.nl.'}, {'ForeName': 'L P H', 'Initials': 'LPH', 'LastName': 'Leenen', 'Affiliation': 'Department of Traumatology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: l.p.h.leenen@umcutrecht.nl.'}]",International emergency nursing,['10.1016/j.ienj.2020.100878']
2824,32505126,Striatal activation to monetary reward is associated with alcohol reward sensitivity.,"One well-known phenotypic risk factor for the development of alcohol use disorder is sensitivity to the rewarding effects of alcohol. In the present study, we examined whether individuals who are sensitive to alcohol reward are also sensitive to nondrug rewards, thereby reflecting a broader individual difference risk factor. Specifically, we tested the hypothesis that subjective response to acute rewarding effects of alcohol would be related to neural activation during monetary reward receipt relative to loss (in the absence of alcohol). Community-recruited healthy young social drinkers (N = 58) completed four laboratory sessions in which they received alcohol (0.8 g/kg) and placebo in alternating order under double-blind conditions, providing self-report measures of subjective response to alcohol at regular intervals. At a separate visit 1-3 weeks later, they completed a reward-guessing game, the 'Doors' task, during fMRI in a drug-free state. Participants who reported greater motivation (i.e., wanting) to consume more alcohol after a single moderate dose of alcohol also exhibited greater neural activation in the bilateral ventral caudate and the nucleus accumbens during reward receipt relative to loss. Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking). Our study is the first to show that measures of alcohol reward are related to neural indices of monetary reward in humans. These results support growing evidence that individual differences in responses to drug and nondrug reward are linked and together form a risk profile for drug use or abuse, particularly in young adults.",2020,"Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking).","['young adults', 'Community-recruited healthy young social drinkers (N\u2009=\u200958']","['alcohol', 'placebo']","['neural activation', 'subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.0330504,"Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking).","[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Radoman', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA. mradom3@uic.edu.'}, {'ForeName': 'Natania A', 'Initials': 'NA', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, 1670 Upham Drive, Columbus, OH, 43205, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychology, University of Kentucky, 171 Funkhouser Drive, Lexington, KY, 40506, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Utah, 50N Medical Drive, Salt Lake City, UT, 84132, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841S Maryland Avenue, Chicago, IL, 60637, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Luan Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, 1670 Upham Drive, Columbus, OH, 43205, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0728-6']
2825,32493473,"Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial.","OBJECTIVES
The primary objective of the study is to assess the safety of a single intravenous infusion of Mesenchymal Stromal Cells (MSCs) in patients with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. Secondary objectives are to determine the effects of MSCs on important clinical outcomes, as described below.
TRIAL DESIGN
REALIST COVID 19 is a randomised, placebo-controlled, triple blinded trial.
PARTICIPANTS
The study will be conducted in Intensive Care Units in hospitals across the United Kingdom. Patients with moderate to severe ARDS as defined by the Berlin definition, receiving invasive mechanical ventilation and with a diagnosis of COVID-19 based on clinical diagnosis or PCR test will be eligible. Patients will be excluded for the following reasons: more than 72 hours from the onset of ARDS; age < 16 years; patient known to be pregnant; major trauma in previous 5 days; presence of any active malignancy (other than non-melanoma skin cancer); WHO Class III or IV pulmonary hypertension; venous thromboembolism currently receiving anti-coagulation or within the past 3 months; patient receiving extracorporeal life support; severe chronic liver disease (Child-Pugh > 12); Do Not Attempt Resuscitation order in place; treatment withdrawal imminent within 24 hours; prisoners; declined consent; non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; previously enrolled in the REALIST trial.
INTERVENTION AND COMPARATOR
Intervention: Allogeneic donor CD362 enriched human umbilical cord derived mesenchymal stromal cells (REALIST ORBCEL-C) supplied as sterile, single-use cryopreserved cell suspension of a fixed dose of 400 x10 6 cells in 40ml volume, to be diluted in Plasma-Lyte 148 to a total volume of 200mls for administration. Comparator (placebo): Plasma-Lyte 148 Solution for Infusion (200mls). The cellular product (REALIST ORBCEL-C) was developed and patented by Orbsen Therapeutics.
MAIN OUTCOMES
The primary safety outcome is the incidence of serious adverse events. The primary efficacy outcome is Oxygenation Index (OI) at day 7. Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2 ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality.
RANDOMISATION
After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen). Randomisation will be stratified by recruitment centre and by vasopressor use and patients will be allocated to REALIST ORBCEL-C or placebo control in a 1:1 ratio.
BLINDING (MASKING)
The investigator, treating physician, other members of the site research team and participants will be blinded. The cell therapy facility and clinical trials pharmacist will be unblinded to facilitate intervention and placebo preparation. The unblinded individuals will keep the treatment information confidential. The infusion bag will be masked at the time of preparation and will be administered via a masked infusion set.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
A sample size of 60 patients with 30 patients randomised to the intervention and 30 to the control group. If possible, recruitment will continue beyond 60 patients to provide more accurate and definitive trial results. The total number of patients recruited will depend on the pandemic and be guided by the data monitoring and ethics committee (DMEC).
TRIAL STATUS
REALIST Phase 1 completed in January 2020 prior to the COVID-19 pandemic. This was an open label dose escalation study of REALIST ORBCEL-C in patients with ARDS. The COVID-19 pandemic emerged as REALIST Phase 2 was planned to commence and the investigator team decided to repurpose the Phase 2 trial as a COVID-19 specific trial. This decision was discussed and approved by the Trial Steering Committee (TSC) and DMEC. Submissions were made to the Research Ethics Committee (REC) and MHRA to amend the protocol to a COVID-19 specific patient population and the protocol amendment was accepted by the REC on 27 th March 2020 and MHRA on 30 th March 2020 respectively. Other protocol changes in this amendment included an increase in the time of onset of ARDS from 48 to 72 hours, inclusion of clinical outcomes as secondary outcomes, the provision of an option for telephone consent, an indicative sample size and provision to continue recruitment beyond this indicative sample size. The current protocol in use is version 4.0 23.03.2020 (Additional file 1). Urgent Public Health status was awarded by the NIHR on 2 April 2020 and the trial opened to recruitment and recruited the first participant the same day. At the time of publication the trial was open to recruitment at 5 sites across the UK (Belfast Health and Social Care Trust, King's College London, Guys and St Thomas' Hospital London, Birmingham Heartlands Hospital and the Queen Elizabeth Hospital Birmingham) and 12 patients have been recruited across these sites. Additional sites are planned to open and appropriate approvals for these are being obtained. It is estimated recruitment will continue for 6 months.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03042143 (Registered 3 Feb 2017). EudraCT 2017-000585-33 (Registered 28 Nov 2017).
FULL PROTOCOL
The full protocol (version 4.0 23.03.2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2 ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality.
RANDOMISATION
After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen).","['2017-000585-33', 'Intensive Care Units in hospitals across the United Kingdom', 'Patients with moderate to severe ARDS', '60 patients with 30 patients randomised to the intervention and 30 to the control group', 'REALIST Phase 1 completed in January 2020 prior to the COVID-19 pandemic', 'Patients will be excluded for the following reasons: more than 72 hours from the onset of ARDS; age < 16 years; patient known to be pregnant; major trauma in previous 5 days; presence of any active malignancy (other than non-melanoma skin cancer); WHO Class III or IV pulmonary hypertension; venous thromboembolism currently receiving anti-coagulation or within the past 3 months; patient receiving extracorporeal life support; severe chronic liver disease (Child-Pugh > 12', 'patients with ARDS', 'English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; previously enrolled in the REALIST trial', 'patients with Acute Respiratory Distress Syndrome (ARDS']","['Comparator (placebo', 'Allogeneic donor CD362', 'Stromal Cell Administration in COVID-19 (REALIST-COVID-19', 'EudraCT', 'Mesenchymal Stromal Cells (MSCs', 'placebo']","['time of onset of ARDS', ' OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2 ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality', 'incidence of serious adverse events', 'Oxygenation Index (OI']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0150646', 'cui_str': 'Interpreter'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.415432,"Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2 ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality.
RANDOMISATION
After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen).","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Gorman', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust London and School of Immunology and Microbial Sciences, King's College London, London, UK.""}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': ""Research and Development lead in Critical Care, Kings Trauma Centre, King's College London, London, UK.""}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Tunnicliffe', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, Birmingham, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Silversides', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McGuigan', 'Affiliation': 'Royal Victoria Hospital, Belfast, UK.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Jackson', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Boyle', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'McFerran', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Cliona', 'Initials': 'C', 'LastName': 'McDowell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McFarland', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Smythe', 'Affiliation': 'NHS Blood and Transplant Service, London, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'NHS Blood and Transplant Service, London, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Patient and Public Representative, Belfast, UK.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Curley', 'Affiliation': 'Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Laffey', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': ""O'Kane"", 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK. d.f.mcauley@qub.ac.uk.""}]",Trials,['10.1186/s13063-020-04416-w']
2826,32494242,Evaluation of basic surgical skill workshop at undergraduate level in the discipline of surgery.,"Objective
To evaluate the effectiveness of basic surgical skill workshop at under graduate level.
Methods
This was randomized controlled study (cross-over design) conducted at Al-Nafees Medical College and hospital from 1 st January to November 30 th 2017. Undergraduate medical students of Year-5 MBBS were randomized into two groups to undergo surgical skills training. One was workshop or interventional Group-A, other was traditional teaching or control Group-B. Online random sampling calculator was used for randomization. Both groups were given a pretest and post-test in the form of two OSATS station.
Results
Total 49 students were enrolled in the study; Group-A had 25 whereas Group-B had 24 students. There was significant difference ( p =0.000) in mean post-test scores of Group-A (36.28±6.75) and Group-B (24.17±5.09) out of 53 on OSATS station-1. Significant statistical difference (p=0.000) in the mean score of post-tests of Group-A (26.08±18.34) and Group-B (14.42±9.24) out of 37 was also noted on OSATS station-2. There was no significant difference in mean pretest scores on both stations in both groups.
Conclusions
This study has suggestions in development of curriculum as it provides a quantitative substantiation indicating that workshop teaching as a learning strategy can essentially augment traditional teaching of technical skills to undergraduate medical students.",2020,There was significant difference ( p =0.000) in mean post-test scores of Group-A (36.28±6.75) and Group-B (24.17±5.09) out of 53 on OSATS station-1.,"['undergraduate medical students', 'Al-Nafees Medical College and hospital from 1 st January to November 30 th 2017', 'Undergraduate medical students of Year-5 MBBS', '49 students were enrolled in the study; Group-A had 25 whereas Group-B had 24 students']","['surgical skills training', 'basic surgical skill workshop', 'traditional teaching or control']",['mean pretest scores'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",49.0,0.0264991,There was significant difference ( p =0.000) in mean post-test scores of Group-A (36.28±6.75) and Group-B (24.17±5.09) out of 53 on OSATS station-1.,"[{'ForeName': 'Maliha', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'Prof. Dr. Maliha Yunus, MBBS, FCPS, MHPE. Professor of Surgery, Al-Nafees Medical College & Hospital, Isra University, Islamabad Campus, Pakistan.'}, {'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Ghani', 'Affiliation': 'Dr. Zeeshan Ghani, MBBS, FCPS, MCPS. Associate Professor of Paediatrics, Al-Nafees Medical College & Hospital, Isra University, Islamabad Campus, Pakistan.'}, {'ForeName': 'Ihtasham Muhammad', 'Initials': 'IM', 'LastName': 'Ch', 'Affiliation': 'Dr. Ihtasham Muhammad Ch., MBBS, FCPS, FRCS. Associate Professor of Surgery, Al-Nafees Medical College & Hospital, Isra University, Islamabad Campus, Pakistan.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Akram', 'Affiliation': 'Dr. Ayesha Akram, MBBS, FCPS, MHPE. Assistant Professor of Gynaecology, HITEC Institute of Medical Sciences, Taxila, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.4.1792']
2827,32494243,Sequential butylphthalide therapy combined with dual antiplatelet therapy in the treatment of acute cerebral infarction.,"Objective
To observe the clinical efficacy of sequential butylphthalide therapy combined with dual antiplatelet therapy in the treatment of elderly patients with acute cerebral infarction (ACI).
Methods
One hundred and twenty-two elderly patients with ACI who were admitted to the department of neurology of our hospital at May 2016-August 2018 were selected grouped into a control group and an observation group by random number table method, 61 in each group. On the basis of conventional treatment, the patients in the control group were given dual antiplatelet therapy (aspirin enteric-coated tablets + clopidogrel bisulfate tablets), while the patients in the observation group were given sequential butylphthalide therapy on the basis of the control group. The clinical effects of the two groups were compared after four weeks of treatment, and the changes of National Institutes of Health Stroke Scale (NIHSS), ADL score, plasma 3-mercaptopyruvate sulphurtransferase (3-MST) and Amyloid β 42 (Aβ 42 ) levels and the occurrence of adverse reactions during treatment were recorded.
Results
The clinical efficacy of the observation group was better than that of the control group (P<0.05). There was no significant difference in NIHSS and ADL scores between the two groups before treatment (P>0.05). After treatment, the NIHSS and ADL scores of the observation group were better than those of the control group (P<0.05). There was no significant difference in plasma levels of 3-MST and AB42 between the two groups before treatment (P>0.05). The level of plasma 3-MST in the observation group was higher than that in the control group, and the level of plasma Aβ42 was lower than that in the control group (P<0.05). No serious adverse reactions occurred during the treatment period in both groups.
Conclusion
Butylphthalide sequential therapy combined with dual antiplatelet therapy is effective in the treatment of elderly ACI. It can effectively improve the plasma level of 3-MST and decrease the plasma level of Aβ42, which is conducive to improving the living ability and neurological function of patients and has high safety.",2020,There was no significant difference in plasma levels of 3-MST and AB42 between the two groups before treatment (P>0.05).,"['acute cerebral infarction', 'elderly patients with acute cerebral infarction (ACI', 'elderly ACI', 'One hundred and twenty-two elderly patients with ACI who were admitted to the department of neurology of our hospital at May 2016-August 2018']","['sequential butylphthalide therapy combined with dual antiplatelet therapy', 'dual antiplatelet therapy (aspirin enteric-coated tablets + clopidogrel bisulfate tablets', 'Sequential butylphthalide therapy combined with dual antiplatelet therapy', 'sequential butylphthalide therapy']","['level of plasma 3-MST', 'serious adverse reactions', 'NIHSS and ADL scores', 'clinical efficacy', 'level of plasma Aβ42', 'plasma levels of 3-MST and AB42', 'changes of National Institutes of Health Stroke Scale (NIHSS), ADL score, plasma 3-mercaptopyruvate sulphurtransferase (3-MST) and Amyloid β 42 (Aβ 42 ) levels and the occurrence of adverse reactions']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0633084', 'cui_str': 'Plavix'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0047542', 'cui_str': '3-mercaptopyruvate sulfurtransferase'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",122.0,0.0153414,There was no significant difference in plasma levels of 3-MST and AB42 between the two groups before treatment (P>0.05).,"[{'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Wo', 'Affiliation': ""Xuewen Wo, Departments of Neurology, Binzhou People's Hospital, Shandong, 256610, China.""}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': ""Jinyan Han, Departments of Neurology, Binzhou People's Hospital, Shandong, 256610, China.""}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Jiajia Wang, Departments of Neurology, Binzhou People's Hospital, Shandong, 256610, China.""}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Xinmin Wang, Departments of Neurology, Binzhou People's Hospital, Shandong, 256610, China.""}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Xiaoying Liu, Departments of Neurology, Binzhou People's Hospital, Shandong, 256610, China.""}, {'ForeName': 'Zhonggong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Zhonggong Wang, Departments of Neurology, Binzhou People's Hospital, Shandong, 256610, China.""}]",Pakistan journal of medical sciences,['10.12669/pjms.36.4.1831']
2828,32494244,Can antibiotic preference affect bleeding in percutaneous nephrolithotomy? Retrospective comparative study of two commonly used antibiotics.,"Objective
Bleeding is one of the most common and alarming complication of percutaneous nephrolithotomy (PCNL). In this study, we aimed to compare the effects of ciprofloxacin and cefuroxime on the bleeding in PCNL procedures.
Methods
The study was a retrospective analysis of 97 patients who underwent PCNL between February 2011 and June 2017. We just included the patients who had single tract lower pole PCNL for more objective evaluation of bleeding in the study. The patients were divided into two groups as ciprofloxacin group (Group-I, n:40) and cefuroxime group (Group-II, n:56) according to the type of antibiotic used in the operation. Patient age, gender, body mass index, stone size, preoperative INR, preoperative and postoperative platelet counts and difference, operative time, need for blood transfusion, postoperative fever, hospital stay, postoperative hemoglobin and hematocrit drop were analyzed.
Results
There was no statistically significant difference in patients' gender distribution, body mass index, preoperative INR, preoperative and postoperative platelet counts, preoperative and postoperative platelet difference, duration of operation, hospital stay, postoperative fever and need for postoperative blood transfusion between two antibiotic groups (p > 0.05). Mean patient age was 42,75±16,97 in Group-I and 35,54±14,71 in Group-II (p < 0.05). The mean stone size of Group-I and Group-II were 27,23±7,05 mm and 30,59±8,20, respectively (p < 0.05). The mean postoperative hemoglobin and hematocrit drop were significantly higher in Group-I than in Group-II. The mean hemoglobin drop was 1,73±0,95 for Group-I and 1,28±0,67 for Group-II (p < 0.05). The mean hematocrit drop was 5,17±2,76 for Group-I and 3,80±1,99 for Group-II (p < 0.05).
Conclusion
On the basis of the results of the initial study, the antibiotic preference in patients undergoing surgery may be one of the bleeding factors during and after PCNL.",2020,"There was no statistically significant difference in patients' gender distribution, body mass index, preoperative INR, preoperative and postoperative platelet counts, preoperative and postoperative platelet difference, duration of operation, hospital stay, postoperative fever and need for postoperative blood transfusion between two antibiotic groups (p > 0.05).","['patients who had single tract lower pole PCNL for more objective evaluation of bleeding in the study', 'patients undergoing surgery', '97 patients who underwent PCNL between February 2011 and June 2017']","['ciprofloxacin', 'cefuroxime', 'ciprofloxacin and cefuroxime', 'antibiotics', 'percutaneous nephrolithotomy (PCNL']","[""patients' gender distribution, body mass index, preoperative INR, preoperative and postoperative platelet counts, preoperative and postoperative platelet difference, duration of operation, hospital stay, postoperative fever and need for postoperative blood transfusion"", 'mean postoperative hemoglobin and hematocrit drop', 'mean stone size', 'mean hemoglobin drop', 'operative time, need for blood transfusion, postoperative fever, hospital stay, postoperative hemoglobin and hematocrit drop', 'mean hematocrit drop']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0424786', 'cui_str': 'Postoperative fever'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",,0.0219656,"There was no statistically significant difference in patients' gender distribution, body mass index, preoperative INR, preoperative and postoperative platelet counts, preoperative and postoperative platelet difference, duration of operation, hospital stay, postoperative fever and need for postoperative blood transfusion between two antibiotic groups (p > 0.05).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Akkoc', 'Affiliation': 'Ali Akkoc, Department of Urology, Faculty of Medicine, Alanya Alaaddin Keykubat University, Alanya, Turkey.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Aydin', 'Affiliation': 'Cemil Aydin, Department of Urology, Faculty of Medicine, Hitit University, Corum, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Ucar', 'Affiliation': 'Murat Ucar, Department of Urology, Faculty of Medicine, Alanya Alaaddin Keykubat University, Alanya, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Topcuoglu', 'Affiliation': 'Murat Topcuoglu, Department of Urology, Faculty of Medicine, Alanya Alaaddin Keykubat University, Alanya, Turkey.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.4.1977']
2829,32494249,Continuous positive pressure ventilation combined with pulmonary surfactant in the treatment of neonatal respiratory distress syndrome.,"Objective
To analyze the clinical effect of nasal continuous positive airway pressure (CPAP) combined with pulmonary surfactant in the treatment of neonatal respiratory distress syndrome (NRDS).
Methods
Eighty-two NRDS patients who received treatment from August 2017 to June 2019 in our hospital were selected and divided into a control group and an observation group using random number table, 41 in each group. The control group was treated with CPAP, and the observation group was treated with pulmonary surfactant injection besides CPAP. The therapeutic effect, blood gas index, mechanical ventilation parameters and occurrence of complications were compared between the two groups.
Results
The total response rate of the observation group was 90.24%, which was significantly higher than 70.73% of the control group, and the difference had statistical significance (P<0.05). After treatment, the improvement of blood gas indexes of the observation group was better than that of the control group. The hospitalization time and duration of oxygen treatment of the observation group were shorter than those of the control group, and the hospitalization cost was higher than the control group (P<0.05). The difference of incidence of complications between the two groups was statistically significant (P<0.05).
Conclusion
Endotracheal injection of pulmonary surfactant combined with CPAP in the treatment of NRDS can enhance the efficacy, promote the recovery of blood gas index, and reduce the parameters of mechanical ventilation and the incidence of complications, which is conducive to improving the respiratory function of the newborn. The therapy is worth application in the treatment of NRDS patients.",2020,"The total response rate of the observation group was 90.24%, which was significantly higher than 70.73% of the control group, and the difference had statistical significance (P<0.05).","['neonatal respiratory distress syndrome (NRDS', 'NRDS patients', 'Methods\n\n\nEighty-two NRDS patients who received treatment from August 2017 to June 2019 in our hospital', 'neonatal respiratory distress syndrome']","['pulmonary surfactant injection besides CPAP', 'CPAP', 'nasal continuous positive airway pressure (CPAP) combined with pulmonary surfactant', 'Continuous positive pressure ventilation combined with pulmonary surfactant']","['hospitalization time and duration of oxygen treatment', 'hospitalization cost', 'total response rate', 'blood gas indexes', 'therapeutic effect, blood gas index, mechanical ventilation parameters and occurrence of complications', 'incidence of complications']","[{'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",82.0,0.015483,"The total response rate of the observation group was 90.24%, which was significantly higher than 70.73% of the control group, and the difference had statistical significance (P<0.05).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': ""Jing Miao, Department of Pediatrics, Binzhou People's Hospital, Shandong, 256610, China.""}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': ""Haitao Xie, Department of Pediatrics, Binzhou People's Hospital, Shandong, 256610, China.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Yanping Zhang, Department of Pediatrics, Binzhou People's Hospital, Shandong, 256610, China.""}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Xiaohui Guo, Department of Pediatrics, Binzhou People's Hospital, Shandong, 256610, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cui', 'Affiliation': ""Min Cui, Department of Pediatrics, Binzhou People's Hospital, Shandong, 256610, China.""}]",Pakistan journal of medical sciences,['10.12669/pjms.36.4.1963']
2830,32494971,Clinical Pharmacology of Statins: an Update.,"PURPOSE OF REVIEW
Statins represent the cornerstone for the treatment of hypercholesterolemia, although muscle-related side effects and dysregulation of glucose metabolism have strongly limited their adherence and compliance especially in primary prevention therapy. The purpose of the present review is to provide the most recent evidence of the efficacy and safety of statins in monotherapy or combination with new lipid-lowering drugs.
RECENT FINDINGS
Recent ""life-long"" analysis conducted on young familial hypercholesterolemia patients, elderly hypocholesterolemic subjects, and from a 20-year follow-up of randomized controlled trial (RCT) have been published confirming that the cardiovascular benefits of statin therapy, in patients for whom it is recommended by current guidelines, greatly outweigh the risks of side effects. In addition, recent therapies to be used in combination with statins have shown to increase the percentage of patients at goal for low-density lipoprotein - cholesterol (LDL-C) with a good safety profile. The cardiovascular (CV) benefits of monoclonal antibodies anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) and ezetimibe, in patients under statin therapy, have been proven by specific RCT, while we are still waiting for the results of bempedoic acid and the small-interfering RNA (si-RNA) anti-PCSK9 inclisiran. Taken together, the approval of new pharmacological agents to be used in combination with statins represents the future for a tailored therapy of cardiovascular disease patients.",2020,"The cardiovascular (CV) benefits of monoclonal antibodies anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) and ezetimibe, in patients under statin therapy, have been proven by specific RCT, while we are still waiting for the results of bempedoic acid and the small-interfering RNA (si-RNA) anti-PCSK9 inclisiran.","['young familial hypercholesterolemia patients, elderly hypocholesterolemic subjects', 'cardiovascular disease patients', 'patients under']","['statin therapy', 'monoclonal antibodies anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) and ezetimibe', 'Statins']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0020445', 'cui_str': 'Familial hypercholesterolemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]",[],,0.0310175,"The cardiovascular (CV) benefits of monoclonal antibodies anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) and ezetimibe, in patients under statin therapy, have been proven by specific RCT, while we are still waiting for the results of bempedoic acid and the small-interfering RNA (si-RNA) anti-PCSK9 inclisiran.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ferri', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, University of Padova, Largo Egidio Meneghetti 2, 35131, Padova, Italy. nicola.ferri@unipd.it.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Corsini', 'Affiliation': 'Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.'}]",Current atherosclerosis reports,['10.1007/s11883-020-00844-w']
2831,30576794,Serological biomarker profiles of rapidly progressive osteoarthritis in tanezumab-treated patients.,"There is a need for efficacious and safe pain treatments for OA (osteoarthritis). The nerve growth factor (NGF) antibody tanezumab is associated with high efficacy, but when combined with chronic NSAID treatment shows an increased risk of rapidly progressive osteoarthritis (RPOA) in a small group of patients.
AIM
The aim of this study was to phenotype with biochemical biomarkers of bone, cartilage, soft tissue, synovial metabolism OA patients who are at risk of developing RPOA type-2, for both limited and chronic NSAIDs users.
MATERIAL AND METHODS
The dataset consisted of OA patients participating in tanezumab trials who used NSAIDs <90 days (limited NSAID users) or chronic users (NSAIDs ≥90 days) over an average 10 month period. Biomarker data were available for 47 cases (RPOA type-2) and 92 controls. Non-linear and linear multivariable predictive models were developed.
RESULTS
By use of two biomarkers at baseline the receiver operating characteristic (ROC) curve area for RPOA type-2 in limited NSAID users was 71%, [CI] (60-83%). OA subjects with this biomarker phenotype had 8-fold higher confidence interval [CI][(2-33)] relative risk of developing RPOA type-2 as compared to OA patients without this phenotype. The AUC of the model in chronic NSAIDs users based on 5 biomarkers was 78%, [CI](69-88%), with 4-fold [CI (2-6)] relative risk of developing RPOA type-2.
CONCLUSION
In this hypothesis generating and exploratory study, we identified combinations of biomarkers associated with OA patients who develop RPOA type-2, which may be related to the pathology of the RPOA type-2 joint.",2019,"By use of two biomarkers at baseline the receiver operating characteristic (ROC) curve area for RPOA type-2 in limited NSAID users was 71%, [CI] (60-83%).","['synovial metabolism OA patients who are at risk of developing RPOA type-2, for both limited and chronic NSAIDs users', 'rapidly progressive osteoarthritis in tanezumab-treated patients', 'OA patients participating in tanezumab trials who used NSAIDs <90 days (limited NSAID users) or chronic users (NSAIDs ≥90 days) over an average 10 month period']",[],['risk of rapidly progressive osteoarthritis (RPOA'],"[{'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3854438', 'cui_str': 'Rapidly progressive osteoarthritis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3854438', 'cui_str': 'Rapidly progressive osteoarthritis'}]",,0.0529476,"By use of two biomarkers at baseline the receiver operating characteristic (ROC) curve area for RPOA type-2 in limited NSAID users was 71%, [CI] (60-83%).","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience, Herlev Hovedgade, DK-2730 Herlev, Denmark. Electronic address: mk@nordicbio.com.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA. Electronic address: Kenneth.M.Verburg@pfizer.com.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA. Electronic address: Christine.West@pfizer.com.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Bay-Jensen', 'Affiliation': 'Nordic Bioscience, Herlev Hovedgade, DK-2730 Herlev, Denmark. Electronic address: acbj@nordicbio.com.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Keller', 'Affiliation': 'Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA. Electronic address: David.S.Keller@pfizer.com.'}, {'ForeName': 'R H G P', 'Initials': 'RHGP', 'LastName': 'Arends', 'Affiliation': 'Pfizer Inc., 445 Eastern Point Road, Groton, CT 06340, USA. Electronic address: Rosalin.Arends@pfizer.com.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2018.12.001']
2832,30815968,Monitoring sequential treatment of actinic keratosis using post-processed images: Ingenol mebutate and cryosurgery.,,2019,,['actinic keratosis using post-processed images'],[],[],"[{'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],[],,0.0136459,,"[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Pasquali', 'Affiliation': 'Dermatology Department, Pius Hospital de Valls, Tarragona, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Segurado-Miravalles', 'Affiliation': 'Dermatology Department, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Baldi', 'Affiliation': 'Department of Environmental, Biological and Pharmaceutical Sciences and Technologies, University of Campania ""Luigi Vanvitelli"", Caserta, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vincenzi', 'Affiliation': 'Campus Biomedico University, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bizzi', 'Affiliation': 'Acsys, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bonavenia', 'Affiliation': 'Acsys, Rome, Italy.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Gonzalez', 'Affiliation': 'Dermatology Department, Hospital Ramón y Cajal, Madrid, Spain.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12460']
2833,31067484,Defining a Minimal Effective Serum Trough Concentration of Secukinumab in Psoriasis: A Step toward Personalized Therapy.,,2019,,[],[],[],[],[],[],,0.013218,,"[{'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Soenen', 'Affiliation': 'Department of Dermatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Meulewaeter', 'Affiliation': 'Department of Dermatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Grine', 'Affiliation': 'Department of Dermatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Van den Berghe', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Brouwers', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Reinhart', 'Initials': 'R', 'LastName': 'Speeckaert', 'Affiliation': 'Department of Dermatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Lanssens', 'Affiliation': 'Private Practice Dermatology Maldegem, Maldegem, Belgium.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Temmerman', 'Affiliation': 'Department of Dermatology, Maria Middelares Hospital, Ghent, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Department of Dermatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Gils', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium. Electronic address: ann.gils@kuleuven.be.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.04.012']
2834,32498534,3D-STI evaluation of the effect of dexrazoxane on the mechanical properties of right ventricular myocardium in breast cancer patients treated with pirarubicin.,"BACKGROUND
Observation indexes used to evaluate the effect of dexrazoxane-anthracycline combinations in breast cancer often only take into account the clinical symptoms, or left ventricular ejection fraction (LVEF), biomarkers [such as creatine kinase MB (CK-MB), brain natriuretic peptide (BNP) and cardiac troponin T (cTnT)], or tumor recurrence rate, improvement of autonomic nerve function or economic benefits. This study aimed to evaluate the effect of dexrazoxane on the changes of mechanical properties of right ventricular myocardium in patients who underwent pirarubicin chemotherapy with three-dimensional speckle-tracking imaging (3D-STI).
METHODS
A total of 64 breast cancer post-operation patients who received pirarubicin chemotherapy were randomly divided into two groups: the experimental group (with dexrazoxane added) and the control group (without dexrazoxane). The mechanical properties of the right ventricular myocardium were monitored by 3D-STI before and after chemotherapy. The levels of serum hypersensitive troponin I (hs-cTnI) and N-terminal B-type pro-natriuretic peptide (NT-proBNP) as well as conventional echocardiographic parameters were also measured.
RESULTS
After chemotherapy, right ventricular global longitudinal strain (RVGLS) and right ventricular global area strain (RVGAS) were significantly reduced in both groups (P<0.05). There was a significant difference between the two groups (P<0.05).
CONCLUSIONS
Dexrazoxane can alleviate the toxicity of pirarubicin in the right ventricular myocardium. 3D-STI is a potential new method for early and accurate evaluation of the mechanical properties and functional changes of the right ventricular myocardium.",2020,The levels of serum hypersensitive troponin,"['breast cancer patients treated with', 'patients who underwent', '64 breast cancer post-operation patients who received']","['dexrazoxane', 'Dexrazoxane', 'pirarubicin chemotherapy with three-dimensional speckle-tracking imaging (3D-STI', 'dexrazoxane added) and the control group (without dexrazoxane', 'pirarubicin', 'pirarubicin chemotherapy', 'dexrazoxane-anthracycline combinations']","['right ventricular global longitudinal strain (RVGLS) and right ventricular global area strain (RVGAS', 'toxicity of pirarubicin', 'levels of serum hypersensitive troponin', 'mechanical properties of right ventricular myocardium', 'left ventricular ejection fraction (LVEF), biomarkers [such as creatine kinase MB (CK-MB), brain natriuretic peptide (BNP) and cardiac troponin T (cTnT']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0086444', 'cui_str': 'Dexrazoxane'}, {'cui': 'C0071126', 'cui_str': 'Pirarubicin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0071126', 'cui_str': 'Pirarubicin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0225885', 'cui_str': 'Structure of myocardium of right ventricle'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}]",64.0,0.0216181,The levels of serum hypersensitive troponin,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Ultrasonography Department, the First People's Hospital of Lianyungang (Lianyungang Clinical Medical College of Nanjing Medical University), Lianyungang 222000, China.""}, {'ForeName': 'Congqing', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""Ultrasonography Department, the First People's Hospital of Lianyungang (Lianyungang Clinical Medical College of Nanjing Medical University), Lianyungang 222000, China.""}, {'ForeName': 'Honge', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Ultrasonography Department, the First People's Hospital of Lianyungang (Lianyungang Clinical Medical College of Nanjing Medical University), Lianyungang 222000, China.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""UCardiology Department, the First People's Hospital of Lianyungang (Lianyungang Clinical Medical College of Nanjing Medical University), Lianyungang 222000, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': ""Ultrasonography Department, the First People's Hospital of Lianyungang (Lianyungang Clinical Medical College of Nanjing Medical University), Lianyungang 222000, China. ym26101@163.com.""}, {'ForeName': 'Pingyang', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Ultrasonography, Nanjing First Hospital, Nanjing Medical University, Nanjing 210006, China. hpy@hotmail.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1074']
2835,32498606,Non-invasive brain stimulation in Stroke patients (NIBS): A prospective randomized open blinded end-point (PROBE) feasibility trial using transcranial direct current stimulation (tDCS) in post-stroke hemispatial neglect.,"Up to 80% of people who experience a right-hemisphere stroke suffer from hemispatial neglect. This syndrome is debilitating and impedes rehabilitation. We carried out a clinical feasibility trial of transcranial direct current stimulation (tDCS) and a behavioural rehabilitation programme, alone or in combination, in patients with neglect. Patients >4 weeks post right hemisphere stroke were randomized to 10 sessions of tDCS, 10 sessions of a behavioural intervention, combined intervention, or a control task. Primary outcomes were recruitment and retention rates, with secondary outcomes effect sizes on measures of neglect and quality of life, assessed directly after the interventions, and at 6 months follow up. Of 288 confirmed stroke cases referred (representing 7% of confirmed strokes), we randomized 8% (0.6% of stroke cases overall). The largest number of exclusions (91/288 (34%)) were due to medical comorbidities that prevented patients from undergoing 10 intervention sessions. We recruited 24 patients over 29 months, with 87% completing immediate post-intervention and 67% 6 month evaluations. We established poor feasibility of a clinical trial requiring repeated hospital-based tDCS within a UK hospital healthcare setting, either with or without behavioural training, over a sustained time period. Future trials should consider intensity, duration and location of tDCS neglect interventions. Trial registration: ClinicalTrials.gov identifier: NCT02401724.",2020,"Patients >4 weeks post right hemisphere stroke were randomized to 10 sessions of tDCS, 10 sessions of a behavioural intervention, combined intervention, or a control task.","['24 patients over 29 months, with 87% completing immediate post-intervention and 67% 6 month evaluations', 'Patients >4 weeks post right hemisphere stroke', 'post-stroke hemispatial neglect', 'patients with neglect', 'Stroke patients (NIBS']","['transcranial direct current stimulation (tDCS', 'tDCS, 10 sessions of a behavioural intervention, combined intervention, or a control task']","['recruitment and retention rates, with secondary outcomes effect sizes on measures of neglect and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0228175', 'cui_str': 'Right cerebral hemisphere structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0751421', 'cui_str': 'Hemispatial Neglect'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",8.0,0.110521,"Patients >4 weeks post right hemisphere stroke were randomized to 10 sessions of tDCS, 10 sessions of a behavioural intervention, combined intervention, or a control task.","[{'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Learmonth', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Christopher S Y', 'Initials': 'CSY', 'LastName': 'Benwell', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Märker', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Dascalu', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Checketts', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Celestine', 'Initials': 'C', 'LastName': 'Santosh', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Barber', 'Affiliation': 'University Hospital Monklands, Lanarkshire, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Walters', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Harvey', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2020.1767161']
2836,32498613,The effects of psychological inoculation on condom use tendencies and barriers; a randomized controlled trial.,"Objective: Condom use prevents the contraction of the HIV. Research shows limited effects of education on increasing condom use. Psychological inoculation (PI) has been found to be more effective in this domain, however, its mechanism is unknown. This study examined effects of PI versus education on condom use barriers and tendencies, and its relations with cognitive dissonance, using a fully automatized online system. Design: The study was a randomized controlled trial (RCT) and included 149 students from a German University randomly assigned to PI or a control condition. Main outcome measures: An indirect condom use test (I-CUTE), a condom use barriers questionnaire, self-reported condom use, and cognitive dissonance estimations were all assessed at baseline and one-month post-intervention. Results: PI significantly increased I-CUTE scores when participants had sexual relations. Control participants increased in self-reported condom use and on I-CUTE scores in people without sexual relations. No changes in barriers were seen in either group. The cognitive dissonance tended to be higher in PI participants as compared to control participants. Conclusions: PI increases I-CUTE scores compared to controls (based on effect sizes), and significantly in those with sexual relations. The role of relationship status and the mechanisms of PI should be further examined.",2020,Control participants increased in self-reported condom use and on I-CUTE scores in people without sexual relations.,['149 students from a German University randomly assigned to PI or a control condition'],"['PI versus education', 'psychological inoculation', 'Psychological inoculation (PI']","['self-reported condom use and on I-CUTE scores', 'cognitive dissonance', 'I-CUTE scores', 'indirect condom use test (I-CUTE), a condom use barriers questionnaire, self-reported condom use, and cognitive dissonance estimations']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",149.0,0.046391,Control participants increased in self-reported condom use and on I-CUTE scores in people without sexual relations.,"[{'ForeName': 'Levy', 'Initials': 'L', 'LastName': 'Einav', 'Affiliation': 'Faculty of Medicine and Pharmacy, Free University of Brussels (VUB), Brussels, Belgium.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Warner', 'Affiliation': 'Faculty of Medicine and Pharmacy, Free University of Brussels (VUB), Brussels, Belgium.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Fleig', 'Affiliation': 'Department of Psychology, Health Psychology, Faculty of Natural Sciences, MSB Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Kaufman', 'Affiliation': 'Department of Health, Behavior & Society, Blomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Deschepper', 'Affiliation': 'Faculty of Medicine and Pharmacy, Free University of Brussels (VUB), Brussels, Belgium.'}, {'ForeName': 'Gidron', 'Initials': 'G', 'LastName': 'Yori', 'Affiliation': 'The Israeli School of Humanitarian Action, Tel Aviv, Israel.'}]",Psychology & health,['10.1080/08870446.2020.1775832']
2837,32498620,Study Design and Rationale of EXPLORER-HCM: Evaluation of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy.,"BACKGROUND
Obstructive hypertrophic cardiomyopathy (oHCM) is characterized by unexplained left ventricular (LV) hypertrophy associated with dynamic LV outflow tract obstruction. Current medical therapies are nonspecific and have limited efficacy in relieving symptoms. Mavacamten is a first-in-class targeted inhibitor of cardiac myosin, which has been shown to reduce LV outflow tract obstruction, improve exercise capacity, and relieve symptoms of oHCM in the PIONEER-HCM phase 2 study.
METHODS
EXPLORER-HCM is a multicenter, phase 3, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of mavacamten in treating symptomatic oHCM. Eligible adults with oHCM and New York Heart Association Functional Class II or III are randomized 1:1 to receive once-daily, oral mavacamten, or matching placebo for 30 weeks. The primary composite functional end point is clinical response at week 30 compared to baseline defined as either (1) an increase in peak oxygen consumption ≥1.5 mL/kg/min and reduction of at least one New York Heart Association class; or (2) an improvement of ≥3.0 mL/kg/min in peak oxygen consumption with no worsening of New York Heart Association class. Secondary end points include change in postexercise LV outflow tract gradient, New York Heart Association class, peak oxygen consumption, and patient-reported outcomes assessed by the Kansas City Cardiomyopathy Questionnaire and a novel HCM-specific instrument. Exploratory end points aim to characterize the effect of mavacamten on multiple aspects of oHCM pathophysiology.
CONCLUSIONS
EXPLORER-HCM is a phase 3 trial in oHCM testing a first-in-class, targeted strategy of myosin inhibition to improve symptom burden and exercise capacity through reducing LV outflow tract obstruction. Results of this trial will provide evidence to support the first disease-specific treatment for HCM.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03470545.",2020,"Secondary end points include change in postexercise LV outflow tract gradient, New York Heart Association class, peak oxygen consumption, and patient-reported outcomes assessed by the Kansas City Cardiomyopathy Questionnaire and a novel HCM-specific instrument.","['Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy', 'Eligible adults with oHCM and New York Heart Association Functional Class II or III']","['mavacamten', 'oral mavacamten, or matching placebo', 'EXPLORER-HCM', 'Mavacamten', 'placebo']","['change in postexercise LV outflow tract gradient, New York Heart Association class, peak oxygen consumption, and patient-reported outcomes assessed by the Kansas City Cardiomyopathy Questionnaire and a novel HCM-specific instrument', 'efficacy and safety', 'clinical response', 'peak oxygen consumption ≥1.5 mL/kg/min and reduction of at least one New York Heart Association class; or (2) an improvement of ≥3.0 mL/kg/min in peak oxygen consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4551472', 'cui_str': 'Hypertrophic obstructive cardiomyopathy'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0225912', 'cui_str': 'Structure of outflow tract of left ventricle'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.241001,"Secondary end points include change in postexercise LV outflow tract gradient, New York Heart Association class, peak oxygen consumption, and patient-reported outcomes assessed by the Kansas City Cardiomyopathy Questionnaire and a novel HCM-specific instrument.","[{'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (C.Y.H.).""}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Olivotto', 'Affiliation': 'Careggi University Hospital, Florence, Italy (I.O.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Yale University, New Haven, CT (D.J.).'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lester', 'Affiliation': 'Mayo Clinic, Phoenix, AZ (S.J.L.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (M.R.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Duke University School of Medicine, Durham, NC (A.W.).'}, {'ForeName': 'Cynthia Burstein', 'Initials': 'CB', 'LastName': 'Waldman', 'Affiliation': 'HCMBeat.com, Los Angeles, CA (C.B.W.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'MyoKardia, Inc, Brisbane, CA (D.Z., A.J.S.).'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Sehnert', 'Affiliation': 'MyoKardia, Inc, Brisbane, CA (D.Z., A.J.S.).'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Heitner', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health and Sciences University, Portland (S.B.H.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.120.006853']
2838,32499125,Effect of Acupuncture in Patients With Irritable Bowel Syndrome: A Randomized Controlled Trial.,"OBJECTIVE
To evaluate the effect and safety of acupuncture for the treatment of irritable bowel syndrome (IBS) through comparisons with those of polyethylene glycol (PEG) 4000 and pinaverium bromide.
PATIENTS AND METHODS
This multicenter randomized controlled trial was conducted at 7 hospitals in China and enrolled participants who met the Rome III diagnostic criteria for IBS between May 3, 2015, and June 29, 2018. Participants were first stratified into constipation-predominant or diarrhea-predominant IBS group. Participants in each group were randomly assigned in a 2:1 ratio to receive acupuncture (18 sessions) or PEG 4000 (20 g/d, for IBS-C)/pinaverium bromide (150 mg/d, for IBS-D) over a 6-week period, followed by a 12-week follow-up. The primary outcome was change in total IBS-Symptom Severity Score from baseline to week 6.
RESULTS
Of 531 patients with IBS who were randomized, 519 (344 in the acupuncture group and 175 in the PEG 4000/ pinaverium bromide group) were included in the full analysis set. From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group. The between-group difference was 28.78 (95% CI, 16.84 to 40.72; P<.001). No participant experienced severe adverse effects.
CONCLUSION
Acupuncture may be more effective than PEG 4000 or pinaverium bromide for the treatment of IBS, with effects lasting up to 12 weeks.
TRIAL REGISTRATION
Chinese Clinical Trials Register, ChiCTR-IOR-15006259.",2020,"From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group.","['irritable bowel syndrome (IBS', 'Patients With Irritable Bowel Syndrome', 'Participants were first stratified into constipation-predominant or diarrhea-predominant IBS group', '7 hospitals in China and enrolled participants who met the Rome III diagnostic criteria for IBS between May 3, 2015, and June 29, 2018', '531 patients with IBS who were randomized, 519 (344 in the acupuncture group and 175 in the PEG 4000/ pinaverium bromide group) were included in the full analysis set']","['acupuncture', 'polyethylene glycol (PEG) 4000 and pinaverium bromide', 'Acupuncture', 'acupuncture (18 sessions) or PEG 4000 (20 g/d, for IBS-C)/pinaverium bromide']","['total IBS-Symptom Severity Score', 'severe adverse effects']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0032479', 'cui_str': 'polyethylene glycol 4000'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0006222', 'cui_str': 'bromides'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",531.0,0.308207,"From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group.","[{'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Geng', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Shuyang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Shuyang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Nantong Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Nantong Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Wuxi Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Wuxi Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Yanye', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China; Kunshan Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Shengjie', 'Initials': 'S', 'LastName': 'Weng', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ju', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China. Electronic address: shenghong999@163.com.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China. Electronic address: 377201634@qq.com.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2020.01.042']
2839,32499235,"Camrelizumab plus gemcitabine, vinorelbine and pegylated liposomal doxorubicin in relapsed/refractory primary mediastinal B-cell lymphoma: a single-arm, open-label, phase 2 trial.","PURPOSE
Patients with relapsed/refractory primary mediastinal B-cell lymphoma (rrPMBCL) represent a particularly challenging population to treat, with few life-saving treatment options in the context of a dismal prognosis.
EXPERIMENTAL DESIGN
In this open-label, single-arm, phase 2 study, the safety and efficacy of combined regimen of chemotherapy consisting of gemcitabine, vinorelbine and pegylated liposomal doxorubicin (GVD) plus anti-PD-1 antibody camrelizumab was assessed in rrPMBCL. Patients received chemo-immunotherapy every 3 weeks until the second confirmed complete response or up to 12 cycles, followed by camrelizumab monotherapy for up to 1 year. The primary endpoints were objective response rate and safety.
RESULTS
27 response-evaluable patients were enrolled, who received a median of 3 frontline therapies, 59% with bulky disease. The objective response rate was 74%, including 56% with a complete response. A median time of 1.7 months to response was observed, with 78% exhibiting tumor shrinkage at the first evaluation. After 24.8 months median follow-up, the median duration of response was not reached, with a 65% 2-year estimated response rate. Thirteen responders remained in sustained complete remission. Estimated 24-M progression-free survival and overall survival rates were 48.2% and 81.5%, respectively. Any-grade and grade 3 treatment-related adverse events occurred in 93% and 33% of patients, respectively; with no grade 4 or 5 adverse events. Baseline levels of IL-10, IFN-γ and sFas were associated with objective response.
CONCLUSIONS
Camrelizumab plus GVD chemotherapy offers a potent option as life-saving chemo-immunotherapy with promising efficacy and a manageable safety profile for rrPMBCL patients, especially with bulky aggressive disease.",2020,"Baseline levels of IL-10, IFN-γ and sFas were associated with objective response.
","['Patients with relapsed/refractory primary mediastinal B-cell lymphoma (rrPMBCL', '27 response-evaluable patients were enrolled, who received a median of 3 frontline therapies, 59% with bulky disease', 'relapsed/refractory primary mediastinal B-cell lymphoma']","['Camrelizumab plus GVD chemotherapy', 'Camrelizumab plus gemcitabine, vinorelbine and pegylated liposomal doxorubicin', 'chemo-immunotherapy', 'camrelizumab monotherapy', 'gemcitabine, vinorelbine and pegylated liposomal doxorubicin (GVD']","['safety and efficacy', 'Baseline levels of IL-10, IFN-γ and sFas', 'sustained complete remission', 'adverse events', 'objective response rate', 'median duration of response', 'objective response rate and safety', 'Estimated 24-M progression-free survival and overall survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0809917,"Baseline levels of IL-10, IFN-γ and sFas were associated with objective response.
","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Mei', 'Affiliation': 'Department of Molecular Biology and Department of Bio-therapeutic, Institute of Basic Medicine, Chinese PLA General Hospital.'}, {'ForeName': 'Wen-Ying', 'Initials': 'WY', 'LastName': 'Zhang', 'Affiliation': 'Department of Bio-therapeutic, Chinese PLA General Hospital.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Bio-therapeutic, Chinese PLA General Hospital.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Bio-therapeutic, Chinese PLA General Hospital.'}, {'ForeName': 'John Ej', 'Initials': 'JE', 'LastName': 'Rasko', 'Affiliation': 'Gene and Stem Cell Therapy Program, Centenary Institute.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Department of Bio-therapeutic, Chinese PLA General Hospital.'}, {'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Bio-therapeutic, Chinese PLA General Hospital.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Molecular Biology and Immunology, Chinese PLA General Hospital.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Bio-therapeutic, Chinese PLA General Hospital.'}, {'ForeName': 'Meixia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Bio-therapeutic, Chinese PLA General Hospital.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Bio-therapeutic, Institute of Basic Medicine, Chinese PLA General Hospital.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Bio-therapeutic, Chinese PLA General Hospital.'}, {'ForeName': 'Huitao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'National Engineering Laboratory for Medical Big Data Application Technology, Chinese PLA General Hospital.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Department of Bio-therapeutic, Chinese PLA General Hospital hanwdrsw69@yahoo.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0514']
2840,32499244,"Lenalidomide before and after ASCT for transplant-eligible patients of all ages in the randomized, phase III, Myeloma XI trial.","The optimal way to use immunomodulatory drugs as components of induction and maintenance therapy for multiple myeloma is unresolved. We addressed this question in a large phase III randomized trial, Myeloma XI. Patients with newly diagnosed multiple myeloma (n = 2042) were randomized to induction therapy with cyclophosphamide, thalidomide, and dexamethasone (CTD) or cyclophosphamide, lenalidomide, and dexamethasone (CRD). Additional intensification therapy with cyclophosphamide, bortezomib and dexamethasone (CVD) was administered before ASCT to patients with a suboptimal response to induction therapy using a response-adapted approach. After receiving high-dose melphalan with autologous stem cell transplantation (ASCT), eligible patients were further randomized to receive either lenalidomide alone or observation alone. Co-primary endpoints were progression-free survival (PFS) and overall survival (OS). The CRD regimen was associated with significantly longer PFS (median: 36 vs. 33 months; hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.75-0.96; P = 0.0116) and OS (3-year OS: 82.9% vs. 77.0%; HR, 0.77; 95% CI, 0.63-0.93; P = 0.0072) compared with CTD. The PFS and OS results favored CRD over CTD across all subgroups, including patients with International Staging System stage III disease (HR for PFS, 0.73; 95% CI, 0.58-0.93; HR for OS, 0.78; 95% CI, 0.56-1.09), high-risk cytogenetics (HR for PFS, 0.60; 95% CI, 0.43-0.84; HR for OS, 0.70; 95% CI, 0.42-1.15) and ultra high-risk cytogenetics (HR for PFS, 0.67; 95% CI, 0.41-1.11; HR for OS, 0.65; 95% CI, 0.34-1.25). Among patients randomized to lenalidomide maintenance (n = 451) or observation (n = 377), maintenance therapy improved PFS (median: 50 vs. 28 months; HR, 0.47; 95% CI, 0.37-0.60; P < 0.0001). Optimal results for PFS and OS were achieved in the patients who received CRD induction and lenalidomide maintenance. The trial was registered with the EU Clinical Trials Register (EudraCT 2009-010956-93) and ISRCTN49407852.",2020,"The PFS and OS results favored CRD over CTD across all subgroups, including patients with International Staging System stage III disease (HR for PFS, 0.73; 95% CI, 0.58-0.93; HR for OS, 0.78; 95% CI, 0.56-1.09), high-risk cytogenetics (HR for PFS, 0.60; 95% CI, 0.43-0.84; HR for OS, 0.70; 95% CI, 0.42-1.15) and ultra high-risk cytogenetics (HR for PFS, 0.67; 95% CI, 0.41-1.11; HR for OS, 0.65; 95% CI, 0.34-1.25).",['Patients with newly diagnosed multiple myeloma (n = 2042'],"['cyclophosphamide, bortezomib and dexamethasone (CVD', 'lenalidomide maintenance', 'melphalan with autologous stem cell transplantation (ASCT', 'cyclophosphamide, thalidomide, and dexamethasone (CTD) or cyclophosphamide, lenalidomide, and dexamethasone (CRD', 'lenalidomide alone or observation alone']","['progression-free survival (PFS) and overall survival (OS', 'PFS', 'ultra high-risk cytogenetics', 'longer PFS', 'high-risk cytogenetics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",2042.0,0.275773,"The PFS and OS results favored CRD over CTD across all subgroups, including patients with International Staging System stage III disease (HR for PFS, 0.73; 95% CI, 0.58-0.93; HR for OS, 0.78; 95% CI, 0.56-1.09), high-risk cytogenetics (HR for PFS, 0.60; 95% CI, 0.43-0.84; HR for OS, 0.70; 95% CI, 0.42-1.15) and ultra high-risk cytogenetics (HR for PFS, 0.67; 95% CI, 0.41-1.11; HR for OS, 0.65; 95% CI, 0.34-1.25).","[{'ForeName': 'Graham H', 'Initials': 'GH', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK; graham.jackson@newcastle.ac.uk.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research & The Royal Marsden Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, UK.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Striha', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, UK.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Collett', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Waterhouse', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Jones', 'Affiliation': 'Kings College Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Bhuvan', 'Initials': 'B', 'LastName': 'Kishore', 'Affiliation': 'Heart of England NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Williams', 'Affiliation': 'Centre for Clinical Haematology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Kamaraj', 'Initials': 'K', 'LastName': 'Karunanithi', 'Affiliation': 'University Hospital of North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Jindriska', 'Initials': 'J', 'LastName': 'Lindsay', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Allotey', 'Affiliation': 'Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Shafeek', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Section of Experimental Haematology, Leeds Institute of Cancer & Pathology, University of Leeds, UK.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Russell', 'Affiliation': 'Centre for Clinical Haematology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology, School of Immunity and Infection, University of Birmingham, UK.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': ""St James's University Hospital, Haematological Malignancy Diagnostic Service (HMDS), Leeds, UK.""}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Haematologica,['10.3324/haematol.2020.247130']
2841,32499254,The KOMPACT-P study: Knee Osteoarthritis Management with Physiotherapy informed by Acceptance and Commitment Therapy-Pilot study protocol.,"INTRODUCTION
Incidence of total knee arthroplasty (TKA) is projected to rise 276% in 2030, and psychological distress affects up to 42% of people with knee osteoarthritis undergoing TKA, with demonstrated detrimental effects on postoperative outcomes. Few studies have assessed psychological treatment in people awaiting TKA, and these have been psychologist-delivered treatments. No evidence exists regarding psychologically-informed interventions delivered by health professionals currently embedded in TKA clinical pathways. The primary aim of this pilot study is to explore the safety, acceptability and feasibility of the K nee O steoarthritis M anagement with P hysiotherapy informed by A cceptance and C ommitment T herapy (KOMPACT) approach in people awaiting TKA.
METHODS AND ANALYSIS
51 community-dwelling adults scheduled for a primary TKA at two hospitals will be recruited to this pilot, mixed-methods, prospective randomised controlled trial with assessor blinding. Participants will be randomised in a 1:2 ratio to either usual care (education class) or usual care plus KOMPACT (2 hours 20 min of preoperative physiotherapy informed by Acceptance and Commitment Therapy). Our primary outcome measures are safety (length of stay, complications and psychological health after KOMPACT), acceptability (treatment credibility and qualitative data) and feasibility (recruitment, retention and intervention fidelity) of the KOMPACT approach. Secondary outcomes include health service outcomes, patient-reported physical and psychological outcomes, and physical performance measures. Quantitative data collection was conducted at baseline, 1-2 weeks before TKA, 6 weeks after TKA and 6 months after TKA. Qualitative data collection is 1-2 weeks before TKA. Data analysis will take a quantitative-led approach with triangulation after thematic analysis of the qualitative data.
ETHICS AND DISSEMINATION
This study has full ethics approval (HREC/18/WMEAD/440). Results from this study will be published in peer-reviewed journals and presented at local and international conferences.
TRIAL REGISTRATION NUMBER
Australia New Zealand Clinical Trials Registry (ACTRN12618001867280p).",2020,"A cceptance and C ommitment T herapy (KOMPACT) approach in people awaiting TKA.
","['51 community-dwelling adults scheduled for a primary TKA at two hospitals', 'people awaiting TKA']","['cceptance and C ommitment T herapy (KOMPACT) approach', 'total knee arthroplasty (TKA', 'usual care (education class) or usual care plus KOMPACT (2\u2009hours 20\u2009min of preoperative physiotherapy informed by Acceptance and Commitment Therapy']","['safety (length of stay, complications and psychological health after KOMPACT), acceptability (treatment credibility and qualitative data) and feasibility (recruitment, retention and intervention fidelity) of the KOMPACT approach', 'health service outcomes, patient-reported physical and psychological outcomes, and physical performance measures', 'safety, acceptability and feasibility of the K nee']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.25181,"A cceptance and C ommitment T herapy (KOMPACT) approach in people awaiting TKA.
","[{'ForeName': 'Marie K', 'Initials': 'MK', 'LastName': 'March', 'Affiliation': 'Physiotherapy Department, Blacktown Mt Druitt Hospital, Western Sydney Local Health District, Blacktown, New South Wales, Australia Marie.March@health.nsw.gov.au.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Harmer', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Godfrey', 'Affiliation': ""Department of Health Psychology, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, United Kingdom.""}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Venkatesh', 'Affiliation': 'Renal Supportive Care, Nepean Blue Mountains Local Health District, Penrith, New South Wales, Australia.'}, {'ForeName': 'Bijoy', 'Initials': 'B', 'LastName': 'Thomas', 'Affiliation': 'Orthopaedic Department, Blacktown Mt Druitt Hospital, Western Sydney Local Health District, Blacktown, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dennis', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032675']
2842,32493502,Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial.,"BACKGROUND
Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations.
METHODS
Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months.
DISCUSSION
The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities.
TRIAL REGISTRATION
This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.",2020,"The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2).","['hypertensive patients', 'Responders with persistent hypertension', 'hypertensive patients treated in an urban, safety net Emergency Department (Aim 2', 'Emergency Department patient population']","['primary care provider appointment assistance', 'healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no', 'behavioral intervention', 'facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center']","['blood pressure', 'systolic blood pressure']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0358591,"The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Meurer', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA. wmeurer@med.umich.edu.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Dinh', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Flood', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Champoux', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Whitfield', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Trimble', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Cowdery', 'Affiliation': 'School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti, MI, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Borgialli', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Montas', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cunningham', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Lorraine R', 'Initials': 'LR', 'LastName': 'Buis', 'Affiliation': 'Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Lesli', 'Initials': 'L', 'LastName': 'Skolarus', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}]",Trials,['10.1186/s13063-020-04340-z']
2843,32493506,Correction to: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],"['indomethacin and prophylactic pancreatic stent placement', 'Rectal indomethacin']",[],[],"[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C2747855', 'cui_str': 'Pancreatic stent placement'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}]",[],,0.0368255,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. elmunzer@musc.edu.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Edmundowicz', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Georgios I', 'Initials': 'GI', 'LastName': 'Papachristou', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Scheiman', 'Affiliation': 'Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Vikesh K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadarajulu', 'Affiliation': 'Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Vargo', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': 'Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Todd H', 'Initials': 'TH', 'LastName': 'Baron', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Coté', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Romagnuolo', 'Affiliation': 'Tidelands Health, Murrels Inlet, SC, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Wood-Williams', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Depue', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04458-0']
2844,32493514,"A prospective, randomised, double blind placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (TOC-COVID): A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES
SARS-CoV2 infection leads to a concomitant pulmonary inflammation. This inflammation is supposed to be the main driver in the pathogenesis of lung failure (Acute Respiratory Distress Syndrome) in COVID-19. Objective of this study is to evaluate the efficacy and safety of a single dose treatment with Tocilizumab in patients with severe COVID-19. We hypothesize that Tocilizumab slows down the progression of SARS-CoV-2 induced pneumonia and inflammation. We expect an improvement in pulmonary function compared to placebo-treated patients. Desirable outcomes would be that tocilizumab reduces the number of days that patients are dependent on mechanical ventilation and reduces the invasiveness of breathing assistance. Furthermore, this treatment might result in fewer admissions to intensive care units. Next to these efficacy parameters, safety of a therapy with Tocilizumab in COVID-19 patients has to be monitored closely, since immunosuppression could lead to an increased rate of bacterial infections, which could negatively influence the patient's outcome.
TRIAL DESIGN
Multicentre, prospective, 2-arm randomised (ratio 1:1), double blind, placebo-controlled trial with parallel group design.
PARTICIPANTS
Inclusion criteria 1.Proof of SARS-CoV2 (Symptoms and positive polymerase chain reaction (PCR))2.Severe respiratory failure: a.Ambient air SpO 2 ≤ 92% orb.Need of ≥ 6l O2/min orc.NIV (non-invasive ventilation) ord.IMV (invasive mechanical ventilation)3.Age ≥ 18 years Exclusion criteria 1.Non-invasive or invasive mechanical ventilation ≥ 48 hours2.Pregnancy or breast feeding3.Liver injury or failure (AST/ALT ≥ 5x ULN)4.Leukocytes < 2 × 10 3 /μl5.Thrombocytes < 50 × 10 3 /μl6.Severe bacterial infection (PCT > 3ng/ml)7.Acute or chronic diverticulitis8.Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate, biologicals, prednisolone >10mg/d; exceptions are: prednisolone ≤ 10mg/d, sulfasalazine or hydroxychloroquine)9.Known active or chronic tuberculosis10.Known active or chronic viral hepatitis11.Known allergic reactions to tocilizumab or its ingredients12.Life expectation of less than 1 year (independent of COVID-19)13.Participation in any other interventional clinical trial within the last 30 days before the start of this trial14.Simultaneous participation in other interventional trials (except for participation in COVID-19 trials) which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed15.Failure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception. The data collection of the primary follow up (28 days after randomisation) takes place during the hospital stay. Subsequently, a telephone interview on the quality of life is conducted after 6 and 12 months. Participants will be recruited from inpatients at ten medical centres in Germany.
INTERVENTION AND COMPARATOR
Intervention arm: Application of 8mg/kg body weight (BW) Tocilizumab i.v. once immediately after randomisation (12 mg/kg for patients with <30kg BW; total dose should not exceed 800 mg) AND conventional treatment. Control arm: Placebo (NaCl) i.v. once immediately after randomisation AND conventional treatment.
MAIN OUTCOMES
Primary endpoint is the number of ventilator free days (d) (VFD) in the first 28 days after randomisation. Non-invasive ventilation (NIV), Invasive mechanical ventilation (IMV) and extracorporeal membrane oxygenation (ECMO) are defined as ventilator days. VFD's are counted as zero if the patient dies within the first 28 days.
RANDOMISATION
The randomisation code will be generated by the CTU (Clinical Trials Unit, ZKS Freiburg) using the following procedure to ensure that treatment assignment is unbiased and concealed from patients and investigator staff. Randomisation will be stratified by centre and will be performed in blocks of variable length in a ratio of 1:1 within each centre. The block lengths will be documented separately and will not be disclosed to the investigators. The randomisation code will be produced by validated programs based on the Statistical Analysis System (SAS).
BLINDING (MASKING)
Participants, caregivers, and the study team assessing the outcomes are blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
100 participants will be randomised to each group (thus 200 participants in total).
TRIAL STATUS
Protocol Version: V 1.2, 16.04.2020. Recruitment began 27th April 2020 and is anticipated to be completed by December 2020.
TRIAL REGISTRATION
The trial was registered before trial start in trial registries (EudraCT: No. 2020-001408-41, registered 21st April 2020, and DRKS: No. DRKS00021238, registered 22nd April 2020).
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Randomisation will be stratified by centre and will be performed in blocks of variable length in a ratio of 1:1 within each centre.,"['18 years Exclusion criteria 1.Non-invasive or invasive mechanical ventilation ≥ 48 hours2.Pregnancy or breast feeding3.Liver injury or failure', 'Participants will be recruited from inpatients at ten medical centres in Germany', '2020-001408-41, registered 21st April 2020, and DRKS', 'COVID-19 patients', 'patients with severe COVID-19 pneumonia (TOC-COVID', '100 participants will be randomised to each group (thus 200 participants in total', 'Inclusion criteria 1.Proof of SARS-CoV2 (Symptoms and positive polymerase chain reaction (PCR))2.Severe respiratory failure: a', 'patients with severe COVID-19']","['IMV (invasive mechanical ventilation)3.Age ≥', 'mycophenolate, azathioprine, methotrexate, biologicals, prednisolone ', 'tocilizumab', 'sulfasalazine or hydroxychloroquine)9.Known active or chronic tuberculosis10.Known active', '8mg/kg body weight (BW) Tocilizumab i.v', 'Tocilizumab', 'Placebo (NaCl) i.v', 'prednisolone', 'placebo']","['quality of life', 'invasive ventilation (NIV), Invasive mechanical ventilation (IMV) and extracorporeal membrane oxygenation (ECMO', 'number of ventilator free days (d) (VFD', 'invasiveness of breathing assistance', 'efficacy and safety', 'pulmonary function']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1835664', 'cui_str': 'Tylosis with esophageal cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",100.0,0.594759,Randomisation will be stratified by centre and will be performed in blocks of variable length in a ratio of 1:1 within each centre.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rilinger', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany. jonathan.rilinger@uniklinik-freiburg.de.'}, {'ForeName': 'Winfried V', 'Initials': 'WV', 'LastName': 'Kern', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine II, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duerschmied', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Supady', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Dawid L', 'Initials': 'DL', 'LastName': 'Staudacher', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Wengenmayer', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}]",Trials,['10.1186/s13063-020-04447-3']
2845,32493523,Protein and carbohydrate distribution among the meals: Effect on metabolic parameters of patients with type 2 diabetes: A single-blinded randomized controlled trial.,"Studies have revealed that the timing of macronutrient ingestion may influence body weight and glucose tolerance. We aimed to examine the effect of high protein versus high carbohydrate intake at the evening meal on metabolic parameters of patients with type 2 diabetes. This is a single-blinded, parallel, randomized controlled trial. 96 patients with type 2 diabetes, aged 32-65 years with a mean body mass index (BMI) of 28.5 ± 3.4 kg/m2 were randomly assigned into one of these three groups: Standard evening meal (ST), High carbohydrate evening meal (HC), and High protein evening meal (HP). Then, the patients were followed for 10 weeks. HbA1c, fasting blood glucose (FBG), fasting insulin, insulin resistance, triglyceride, low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), diastolic blood pressure, body weight, body fat percentage, and waist circumference decreased significantly in all three groups (P < 0.05). HbA1c showed more improvement in the ST compared with the HP group (- 0.45 ± 0.36 vs. - 0.26 ± 0.36). Reductions in BMI and body weight were significantly higher in the ST compared with the HP group (P < 0.05). Reductions in total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), and systolic blood pressure were significant in all groups, except for the HP group. Non-HDL-C/HDL-C remained unchanged in all groups. The results of the present study revealed that even distribution of carbohydrates and protein among meals compared with reducing carbohydrates and increasing protein at dinner may have a more beneficial effect on glycemic control of patients with type 2 diabetes.",2020,Reductions in BMI and body weight were significantly higher in the ST compared with the HP group (P < 0.05).,"['96 patients with type 2 diabetes, aged 32-65 years with a mean body mass index (BMI) of 28.5 ± 3.4 kg/m2', 'patients with type 2 diabetes', 'patients with type']","['high protein versus high carbohydrate intake', 'Standard evening meal (ST), High carbohydrate evening meal (HC), and High protein evening meal (HP']","['body weight and glucose tolerance', 'BMI and body weight', 'HbA1c, fasting blood glucose (FBG), fasting insulin, insulin resistance, triglyceride, low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), diastolic blood pressure, body weight, body fat percentage, and waist circumference', 'metabolic parameters', 'total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), and systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0585040', 'cui_str': 'Evening meal'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",96.0,0.0232922,Reductions in BMI and body weight were significantly higher in the ST compared with the HP group (P < 0.05).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nouripour', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mazloom', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fararouei', 'Affiliation': 'Department of Epidemiology, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zamani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The British journal of nutrition,['10.1017/S0007114520001944']
2846,32493624,In vitro evaluation of enamel surface roughness and morphology after orthodontic debonding: Traditional cleanup systems versus polymer bur.,"INTRODUCTION
The primary aim of this randomized in vitro study was to compare the effectiveness of carbide, fibreglass and polymer burs on resinous remnant removal after bracket debonding, by the evaluation of enamel surface roughness and morphology. The secondary objective was to compare the time dispended on the procedures.
METHODS
The buccal surfaces of 28 bovine incisors were analysed by a profilometer to initial roughness measurement (Ra-T1). Brackets were bonded with a light-cured resin and debonded with a debonding plier. The samples were randomly divided into four groups, according to the bur used (n=7): A-Tungsten carbide; B-Fibreglass; C-Polymer; D-Polymer with 75% ethanol pre-treatment. The second roughness measurements were made after resin removal (Ra-T2). Time for removal procedures was also recorded. The third measurements were made after polishing (Ra-T3). Scanning Electronic Microscopy was performed in two samples of each group: after resin removal and after polishing. Results of roughness and time measurements were statically analysed by analysis of variance with post-hoc Bonferroni.
RESULTS
After polishing, tungsten carbide (P=0.1555) and fibreglass burs provided final surface roughness statistically similar to the baseline condition (P=1.0000). Yet, polymer burs, associated (P<0.0001) or not to alcohol (P<0.0001), provided surface roughness significantly higher when compared to baseline values. Polymer burs were more time-consuming on resinous remnant removal than tungsten carbide and fibreglass burs (P<0.05).
CONCLUSION
Polymer burs were less effective and more time-consuming to remove the remaining resin than tungsten carbide and fibreglass burs. The polishing step created smoother surfaces regardless of the burs used for resin removal.",2020,"Polymer burs were more time-consuming on resinous remnant removal than tungsten carbide and fibreglass burs (P<0.05).
",[],"['Tungsten carbide; B-Fibreglass; C-Polymer; D-Polymer with 75% ethanol pre-treatment', 'carbide, fibreglass and polymer burs']",[],[],"[{'cui': 'C0077514', 'cui_str': 'tungsten carbide'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0700351', 'cui_str': 'Bur'}]",[],28.0,0.0282465,"Polymer burs were more time-consuming on resinous remnant removal than tungsten carbide and fibreglass burs (P<0.05).
","[{'ForeName': 'Karen Christina', 'Initials': 'KC', 'LastName': 'Soares Tenório', 'Affiliation': 'Guarulhos University, Department of Orthodontics, São Paulo, Brazil.'}, {'ForeName': 'Murilo Fernando', 'Initials': 'MF', 'LastName': 'Neupmann Feres', 'Affiliation': 'University of São Paulo, School of Dentistry of Ribeirão Preto, Department of Pediatric Dentistry, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Caio Junji', 'Initials': 'CJ', 'LastName': 'Tanaka', 'Affiliation': 'Guarulhos University, Department of Orthodontics, São Paulo, Brazil.'}, {'ForeName': 'Mayara Karolyne Mello', 'Initials': 'MKM', 'LastName': 'Augusto', 'Affiliation': 'Guarulhos University, Department of Orthodontics, São Paulo, Brazil.'}, {'ForeName': 'José Augusto', 'Initials': 'JA', 'LastName': 'Rodrigues', 'Affiliation': 'São Judas University, Department of Restorative Dental Sciences, São Paulo, Brazil.'}, {'ForeName': 'Hélio Doyle', 'Initials': 'HD', 'LastName': 'Pereira da Silva', 'Affiliation': 'Guarulhos University, Department of Orthodontics, São Paulo, Brazil.'}, {'ForeName': 'Victor Elias', 'Initials': 'VE', 'LastName': 'Arana-Chavez', 'Affiliation': 'University of São Paulo, School of Dentistry, Department of Biomaterials and Oral Biology, São Paulo, Brazil.'}, {'ForeName': 'Marina Guimarães', 'Initials': 'MG', 'LastName': 'Roscoe', 'Affiliation': 'University of São Paulo, School of Dentistry, Department of Biomaterials and Oral Biology, São Paulo, Brazil. Electronic address: marinaroscoe@usp.br.'}]",International orthodontics,['10.1016/j.ortho.2020.04.006']
2847,32498426,"Amino Acid Plasma Profiles from a Prolonged-Release Protein Substitute for Phenylketonuria: A Randomized, Single-Dose, Four-Way Crossover Trial in Healthy Volunteers.","Several disorders of amino acid (AA) metabolism are treated with a protein-restricted diet supplemented with specific AA mixtures. Delivery kinetics impacts AA absorption and plasma concentration profiles. We assessed plasma profiles after ingestion of an AA mixture engineered to prolong AA absorption with Physiomimic Technology TM (Test) in a randomized, single-dose, four-way crossover trial in healthy volunteers (Trial Registration: ISRCTN11016729). In a two-step hypothesis, the primary endpoints were (i) significant reduction in peak plasma concentrations (C max ) of essential amino acids (EAAs) while (ii) maintaining EAA bioavailability (AUC 0-300 min ) compared to a free AA mixture (Reference). Secondary endpoints included effects on plasma profiles of other AA groups and effects on several metabolic markers. Thirty subjects completed the study. Both co-primary endpoints were met: C max for EAAs was 27% lower with the Test product compared to the Reference product (ratio, 0.726, p < 0.0001); overall plasma EAA levels from the two AA mixtures was within the pre-specified bioequivalence range (AUC 0-300min ratio, 0.890 (95% CI: 0.865, 0.915)). These findings were supported by the results of secondary endpoints. Prolongation of AA absorption was associated with modulation of several metabolic markers. It will be important to understand whether this can improve the long-term management of disorders of AA metabolism.",2020,"C max for EAAs was 27% lower with the Test product compared to the Reference product (ratio, 0.726, ","['Phenylketonuria', 'Healthy Volunteers', 'healthy volunteers', 'Thirty subjects completed the study']",[],"['C max for EAAs', 'plasma EAA levels', 'peak plasma concentrations (C max ) of essential amino acids (EAAs) while (ii) maintaining EAA bioavailability', 'Prolongation of AA absorption', 'plasma profiles of other AA groups and effects on several metabolic markers']","[{'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0243046', 'cui_str': 'Excitatory Amino Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}]",30.0,0.186598,"C max for EAAs was 27% lower with the Test product compared to the Reference product (ratio, 0.726, ","[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'CRST Oy, Itäinen Pitkäkatu 4B, FI-20520 Turku, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Barassi', 'Affiliation': 'APR Applied Pharma Research sa via Corti 5, CH-6828 Balerna, Switzerland.'}, {'ForeName': 'Jouni', 'Initials': 'J', 'LastName': 'Junnila', 'Affiliation': 'Oy 4Pharma Ltd., Arkadiankatu 7, FI-00100 Helsinki, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'CRST Oy, Itäinen Pitkäkatu 4B, FI-20520 Turku, Finland.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Reiner', 'Affiliation': 'APR Applied Pharma Research sa via Corti 5, CH-6828 Balerna, Switzerland.'}, {'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Sarkkinen', 'Affiliation': 'Food and Nutrition, Oy Medfiles Ltd. (CRO), P. O. Box 1450, FI-70701 Kuopio, Finland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'MacDonald', 'Affiliation': ""Dietetic Department, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham B4 6NH, UK.""}]",Nutrients,['10.3390/nu12061653']
2848,32498526,Clinical effectiveness of matrine sitz bath in treating perianal infection after chemotherapy for acute leukemia.,"BACKGROUND
Perianal infection is a common complication in patients with acute leukemia receiving chemotherapy. It usually manifests as a perianal mass, with redness/swelling, heat, and pain, and can affect physical and mental health in severe cases. The purpose of this study was to investigate the effectiveness of matrine sitz bath (MSB) in treating perianal infection after chemotherapy for acute leukemia.
METHODS
A total of 216 acute leukemia patients with perianal infection that developed during chemotherapy were enrolled in this study and equally randomized into an MSB group and control group. The control group was treated with the conventional potassium permanganate sitz bath. After 14 days of treatment, the clinical efficacy and symptom/sign scores were compared between these 2 groups. The serum levels of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-10(IL-10), erythrocyte sedimentation rate (ESR), and prostaglandin E2 (PGE2) were detected by using enzyme-linked immunosorbent assay (ELISA).
RESULTS
The clinical efficacy of MSB group was significantly superior to that of the control group (P<0.05). The scores of anal pain, systemic symptoms, mass size, and mass texture were significantly decreased after treatment in both groups (P<0.05), and they were significantly lower in the MSB group than in the control group (P<0.05). After treatment, the serum levels of hs-CRP, TNF-α, ESR, and PGE2 in these 2 groups significantly dropped (P<0.05), and they were significantly lower in the MSB group than in the control group (P<0.05); IL-10 level significantly rose in both groups (P<0.05), and it was significantly higher in the MSB group than in the control group (P<0.05).
CONCLUSIONS
MSB is effective in treating perianal infection after chemotherapy for acute leukemia as it can effectively improve symptoms and signs and alleviate inflammatory reactions.",2020,"The scores of anal pain, systemic symptoms, mass size, and mass texture were significantly decreased after treatment in both groups (P<0.05), and they were significantly lower in the MSB group than in the control group (P<0.05).","['acute leukemia', 'patients with acute leukemia receiving chemotherapy', '216 acute leukemia patients with perianal infection that developed during chemotherapy']","['conventional potassium permanganate sitz bath', 'matrine sitz bath (MSB', 'matrine sitz bath', 'MSB']","['serum levels of hs-CRP, TNF-α, ESR, and PGE2', 'scores of anal pain, systemic symptoms, mass size, and mass texture', 'serum levels of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-10(IL-10), erythrocyte sedimentation rate (ESR), and prostaglandin E2 (PGE2', 'clinical efficacy and symptom/sign scores', 'IL-10 level']","[{'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0581363', 'cui_str': 'Perianal infection'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032838', 'cui_str': 'Potassium Permanganate'}, {'cui': 'C0065751', 'cui_str': 'matrine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238637', 'cui_str': 'Anal pain'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",216.0,0.0270295,"The scores of anal pain, systemic symptoms, mass size, and mass texture were significantly decreased after treatment in both groups (P<0.05), and they were significantly lower in the MSB group than in the control group (P<0.05).","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Jiangnan University, Wuxi 214041, China.'}, {'ForeName': 'Huaqiang', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Jiangnan University, Wuxi 214041, China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Hua', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Jiangnan University, Wuxi 214041, China.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Jiangnan University, Wuxi 214041, China.'}, {'ForeName': 'Zhiqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Jiangnan University, Wuxi 214041, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Jiangnan University, Wuxi 214041, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Jiangnan University, Wuxi 214041, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Jiangnan University, Wuxi 214041, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Jiangnan University, Wuxi 214041, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Internal Medicine, Wuxi Maternity and Child Health Hospital, Wuxi 214002, China. 706512989@qq.com.'}]",Annals of palliative medicine,['10.21037/apm-20-912']
2849,32498530,Nutrition counseling combined with head and neck rehabilitation exercises can enhance outcomes among nasopharyngeal carcinoma patients in southern China: a prospective study in an epidemic area.,"BACKGROUND
More than two thirds of new of nasopharyngeal carcinoma (NPC) cases occurring in the east and southeast parts of Asia. As a consequence, the development of intervention programs that can educate and assist patients of NPC in adopting and maintaining long-term behavioral changes to prevent further progression of the disease and improve quality of life represents a continuing need.
METHODS
Patients diagnosed with NPC (n=141) completed chronic disease self-management questionnaires (CDSMP) before, immediately after, and 3, 6, and 12 months after receiving primary cancer treatment. An independent-samples T test was used to compare mean changes in chronic disease self-management (CDSM) items between the intervention group and control group.
RESULTS
There was no difference between the two groups at baseline. Patients who received an intervention demonstrated a significant improvement in fatigue and shortness of breath after treatment. They also demonstrated significant improvements in weekly minutes of aerobic exercise and stretching/strengthening exercise. These advantages lessened slightly with elapsed time.
CONCLUSIONS
For NPC patients, nutrition counseling combined with head and neck rehabilitation exercises can greatly reduce fatigue and shortness of breath and greatly increase the use of stretching/strengthening and aerobic exercise 3 months after intensity-modulated radiotherapy (IMRT).",2020,"CONCLUSIONS
For NPC patients, nutrition counseling combined with head and neck rehabilitation exercises can greatly reduce fatigue and shortness of breath and greatly increase the use of stretching/strengthening and aerobic exercise 3 months after intensity-modulated radiotherapy (IMRT).","['nasopharyngeal carcinoma patients in southern China', 'More than two thirds of new of nasopharyngeal carcinoma ', 'Patients diagnosed with NPC (n=141) completed chronic disease self-management questionnaires (CDSMP) before, immediately after, and 3, 6, and 12 months after receiving primary cancer treatment']","['nutrition counseling combined with head and neck rehabilitation exercises', 'Nutrition counseling combined with head and neck rehabilitation exercises']","['aerobic exercise and stretching/strengthening exercise', 'fatigue and shortness of breath', 'chronic disease self-management (CDSM) items']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]",,0.0317112,"CONCLUSIONS
For NPC patients, nutrition counseling combined with head and neck rehabilitation exercises can greatly reduce fatigue and shortness of breath and greatly increase the use of stretching/strengthening and aerobic exercise 3 months after intensity-modulated radiotherapy (IMRT).","[{'ForeName': 'Dongfang', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China; Department of Clinical Nutrition, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China;Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China;Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jianmei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China;Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China; Department of Breast Surgery, 5Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Linmin', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China;Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China;Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China;Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China; Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China. licong2@sysucc.org.cn.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China;Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China. fanyy@sysucc.org.cn.'}]",Annals of palliative medicine,['10.21037/apm-20-1053']
2850,32498532,Clinical effect of Rougan Tongdu combined with point-pressing massage therapy on children at high risk of delayed motor development.,"BACKGROUND
Delayed motor development (DMD) is an extremely common development disorder in children. Multiple factors, including mother's influence, diseases, physical or chemical factors and trauma, are strongly associated with DMD. Infancy is a key period in the development of neuromotor function. For children who are at high risk of DMD, early clinical intervention can, to a certain extent, reverse and repair the damaged function of the brain, improving the child's prognosis and their quality of life. This study aimed to evaluate the effect of Rougan Tongdu combined with point-pressing massage therapy (RT-PMT) in children at high risk of DMD.
METHODS
Between March 2017 and March 2019, a total of 63 children at high risk of DMD were admitted and treated with RT-PMT in our hospital. These children were divided into three intervention groups (IGs) based on their age in months: IG I (22, 0-3 months), IG II (25, 4-6 months), and IG III (16, 7-12 months). An additional 63 healthy age-matched children were enrolled as a control group (CG) and split into the CG I (0-3 months), CG II (4-6 months), and CG III (7-12 months). All of the children underwent Gesell Infant Development Scale (GESELL) examination both before and three months after intervention and the motor function was scored.
RESULTS
After 3 months of RT-PMT, the gross motor function scores in the three IGs were 88.55±8.56, 81.83±7.95, and 78.89±7.52, respectively. Fine motor function scores in the three IGs were 89.12±6.45, 82.32±6.78, and 78.18±6.69, respectively. Total motor function scores in the three IGs were 89.85±7.20, 82.65±7.05, and 79.52±7.16, respectively. The differences between the scores before and after intervention were statistically significant (all P<0.05). The improvements in the gross, fine, and total motor function scores in IG I were better than those in the other two IGs (P<0.05), and the clinical curative effect in IG I, II, and III was 95.5%, 80.0% and 62.6%, respectively. The clinical curative effect in IG I was better than those in the other groups (P<0.05).
CONCLUSIONS
RT-PMT is beneficial for children at high risk of DMD.",2020,"The improvements in the gross, fine, and total motor function scores in IG I were better than those in the other two IGs (P<0.05), and the clinical curative effect in IG I, II, and III was 95.5%, 80.0% and 62.6%, respectively.","['children at high risk of delayed motor development', 'children at high risk of DMD', 'children', '63 healthy age-matched children', 'Between March 2017 and March 2019, a total of 63 children at high risk of DMD were admitted and treated with RT-PMT in our hospital']","['Rougan Tongdu combined with point-pressing massage therapy (RT-PMT', 'RT-PMT', 'control group (CG) and split into the CG', 'Rougan Tongdu combined with point-pressing massage therapy']","['clinical curative effect', 'Total motor function scores', ""mother's influence, diseases, physical or chemical factors and trauma"", 'gross motor function scores', 'gross, fine, and total motor function scores', 'Fine motor function scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0562229', 'cui_str': 'Fine motor functions'}]",63.0,0.0344443,"The improvements in the gross, fine, and total motor function scores in IG I were better than those in the other two IGs (P<0.05), and the clinical curative effect in IG I, II, and III was 95.5%, 80.0% and 62.6%, respectively.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guizhou University of Chinese Traditional Medicine, Guiyang, China. yangcool_777@163.com.'}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Geng', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guizhou University of Chinese Traditional Medicine, Guiyang, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guizhou University of Chinese Traditional Medicine, Guiyang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guizhou University of Chinese Traditional Medicine, Guiyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ping', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guizhou University of Chinese Traditional Medicine, Guiyang, China.'}]",Annals of palliative medicine,['10.21037/apm-20-1057']
2851,32499730,"Efficacy, Safety, and Tolerability of Theta-Burst Stimulation in Mixed Depression: Design, Rationale, and Objectives of a Randomized, Double-Blinded, Sham-Controlled Trial.","Introduction
Mixed-specifier mood disorders are probably a different subgroup in terms of response to treatment, socio-demographic parameters, course, and family history. Here we describe the rationale and design of a clinical trial aimed to test the efficacy, safety, and tolerability of a non-pharmacological treatment known as theta-burst stimulation (TBS) for treating the mixed depressive episodes of both bipolar (I or II), and unipolar depression.
Methods
The study is designed as a randomized, sham-controlled, double-blinded clinical trial evaluating TBS for the treatment of moderate or severe major depressive episodes with mixed features of patients receiving at least one first or second-line pharmacological treatment for depressive episodes without adequate response. Ninety adult (18 to 65 years old) patients will be enrolled and submitted to 6-week (comprising 5 consecutive days a week sessions for the first 3 weeks and then 2 days a week for a further 3 week) of inhibitory followed by excitatory TBS in dorsolateral prefrontal cortex. Participants will be assessed using clinical and neuropsychological tests before and after the intervention. The primary outcome is change in Montgomery-Åsberg Depression Scale (MADRS) score over time and across groups. Cognitive parameters will also be assessed with neuropsychological tests.
Results
The clinical results will provide evidence about TBS as an adjunctive treatment for mixed depression treatment and neuropsychological parameters will contribute toward an improved understanding the effects of TBS in cognition.
Conclusion
Our results could introduce a novel therapeutic technique for mixed depressive episodes of both bipolar and unipolar disorders.
Clinical Trial Registration
www.ClinicalTrials.gov, identifier NCT04123301; date of registration: 10/10/2019; URL: https://clinicaltrials.gov/ct2/show/NCT04123301?term=NCT04123301&rank=1.",2020,"Introduction
Mixed-specifier mood disorders are probably a different subgroup in terms of response to treatment, socio-demographic parameters, course, and family history.","['Mixed Depression', 'moderate or severe major depressive episodes with mixed features of patients receiving at least one first or second-line pharmacological treatment for depressive episodes without adequate response', 'Ninety adult (18 to 65 years old) patients will be enrolled and submitted to 6-week']","['Theta-Burst Stimulation', 'theta-burst stimulation (TBS', 'TBS', 'inhibitory followed by excitatory TBS']","['efficacy, safety, and tolerability', 'change in Montgomery-Åsberg Depression Scale (MADRS) score', 'Efficacy, Safety, and Tolerability']","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.254903,"Introduction
Mixed-specifier mood disorders are probably a different subgroup in terms of response to treatment, socio-demographic parameters, course, and family history.","[{'ForeName': 'Diego Freitas', 'Initials': 'DF', 'LastName': 'Tavares', 'Affiliation': 'Department of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carla Garcia Rodrigues', 'Initials': 'CGR', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leandro Da Costa Lane', 'Initials': 'LDCL', 'LastName': 'Valiengo', 'Affiliation': 'Department of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Izio', 'Initials': 'I', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Borrione', 'Affiliation': 'Department of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Pamela Marques', 'Initials': 'PM', 'LastName': 'Forte', 'Affiliation': 'Department of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo Alberto', 'Initials': 'RA', 'LastName': 'Moreno', 'Affiliation': 'Department of Psychiatry, University of São Paulo, São Paulo, Brazil.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00435']
2852,32499733,"""Overcoming the Fear That Haunts Your Success"" - The Effectiveness of Interventions for Reducing the Impostor Phenomenon.","The impostor phenomenon (IP) refers to intense thoughts of fraudulence reported by high-achieving individuals. Since it has been shown to account for several personal and work-related complications, effective interventions are greatly needed. Against the background of mindset theory, we developed and tested two mindset interventions. We evaluated the impact of a coaching and a training intervention adopting a randomized controlled outcome design. One hundred and three young employees were randomly assigned to receive coaching ( n = 36), training ( n = 33), or no intervention ( n = 34). Results reveal that coaching was an effective mindset intervention for sustainably reducing IP scores. Fear of negative evaluation emerged to mediate the relation between the coaching intervention and the reduced IP scores significantly. Moreover, coaching improved self-enhancing attributions and self-efficacy and reduced the tendency to cover up errors as well as the fear of negative evaluation. Training was superior in regard to knowledge acquisition. Specific implications are discussed.",2020,"Moreover, coaching improved self-enhancing attributions and self-efficacy and reduced the tendency to cover up errors as well as the fear of negative evaluation.",['One hundred and three young employees'],"['coaching', 'coaching and a training intervention']",['self-enhancing attributions and self-efficacy'],"[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",103.0,0.012241,"Moreover, coaching improved self-enhancing attributions and self-efficacy and reduced the tendency to cover up errors as well as the fear of negative evaluation.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Zanchetta', 'Affiliation': 'Department of Psychology, Paris-Lodron-University of Salzburg (PLUS), Salzburg, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Junker', 'Affiliation': 'Department of Psychology, Paris-Lodron-University of Salzburg (PLUS), Salzburg, Austria.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Wolf', 'Affiliation': 'Department of Psychology, Paris-Lodron-University of Salzburg (PLUS), Salzburg, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Traut-Mattausch', 'Affiliation': 'Department of Psychology, Paris-Lodron-University of Salzburg (PLUS), Salzburg, Austria.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00405']
2853,32499757,Aromatase Inhibitors Plus Weight Loss Improves the Hormonal Profile of Obese Hypogonadal Men Without Causing Major Side Effects.,"Objective: In obese men, the increased expression of the aromatase enzyme in adipose tissue leads to high conversion of androgens to estrogens contributing to hypogonadotropic hypogonadism (HHG). Our objective is to evaluate efficacy and safety of weight loss (WL) plus aromatase inhibitor (AI) therapy in severely obese men with HHG. We hypothesize that AI+WL will be more effective as compared to WL alone in improving the hormonal profile, thus muscle strength and symptoms of HHG (primary outcomes), with no significant adverse effects on lean mass, metabolic profile, and bone mineral density (secondary outcomes). Design: Randomized double-blind placebo-controlled pilot trial. Methods: Twenty-three obese men (BMI≥35 kg/m 2 ), 35-65 years old, were randomized to weight loss (diet and exercise) plus either anastrozole (AI+WL, n = 12) at 1 mg daily or placebo (PBO+WL, n = 11) for 6 months. Inclusion criteria: total testosterone <300 ng/mL (average of 2 measurements), estradiol≥10.9 pg/ml, LH <9 IU/l. Symptoms of hypogonadism by questionnaires; muscle strength by Biodex dynamometer; body composition and bone mineral density by dual-energy X-ray absorptiometry; bone microarchitecture and finite element analysis by high resolution peripheral quantitative-computed tomography. Results: After 6 months of therapy, AI+WL group had higher testosterone ( p = 0.003) and lower estradiol ( p = 0.001) compared to PBO+WL. Changes in symptoms and muscle strength did not differ between groups. AI+WL resulted in higher fat mass loss than PBO+WL ( p = 0.04) without differences in changes in lean mass. Total and LDL cholesterol reduced more in the PBO+WL group compared to AI+WL ( p = 0.03 for both), who experienced a minimal increase with unlikely meaningful clinical impact. Tibial trabecular bone area decreased more in PBO+WL than AI+WL group for which it remained stable ( p = 0.03). Conclusions: Although AI+WL is effective in reversing the hormonal profile of HHG in severely obese men without causing major side effects, it does not lead to greater improvements in muscle strength and symptoms of hypogonadism compared to WL alone. Clinical Trial Registration : www.ClinicalTrials.gov, identifier: NCT02959853.",2020,AI+WL resulted in higher fat mass loss than PBO+WL ( p = 0.04) without differences in changes in lean mass.,"['severely obese men', 'severely obese men with HHG', 'obese men', 'Twenty-three obese men (BMI≥35 kg/m 2 ), 35-65 years old', 'Obese Hypogonadal Men']","['weight loss (diet and exercise) plus either anastrozole (AI+WL, n = 12) at 1 mg daily or placebo', 'estradiol≥10.9 pg/ml, LH', 'weight loss (WL) plus aromatase inhibitor (AI) therapy', 'Aromatase Inhibitors Plus Weight Loss', 'placebo']","['lower estradiol', 'Tibial trabecular bone area', 'muscle strength and symptoms of hypogonadism', 'Total and LDL cholesterol', 'higher testosterone', 'lean mass, metabolic profile, and bone mineral density', 'Changes in symptoms and muscle strength']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0860850', 'cui_str': 'Oestradiol decreased'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0241358', 'cui_str': 'Testosterone increased'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",23.0,0.267862,AI+WL resulted in higher fat mass loss than PBO+WL ( p = 0.04) without differences in changes in lean mass.,"[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Colleluori', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Christie G', 'Initials': 'CG', 'LastName': 'Turin', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Vigevano', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': 'Division of Mathematics and Statistics, University of New Mexico School of Medicine, Albuquerque, NM, United States.'}, {'ForeName': 'Biju', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Research Pharmacy, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mediwala', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Armamento-Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00277']
2854,32500298,Effects of high-frequency repetitive transcranial magnetic stimulation on reach-to-grasp performance in individuals with Parkinson's disease: a preliminary study.,"Individuals with Parkinson's disease (PD) have deficits in reach-to-grasp (RTG) execution and visuospatial processing which may be a result of dopamine deficiency in two brain regions: primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC). We hypothesized that improvement following M1 stimulation would be the result of a direct impact on motor execution; whereas, DLPFC stimulation would improve the role of DLPFC in visuospatial processing. The aim of pilot study was to investigate the effects of HF-rTMS on RTG performance by stimulating either M1 or DLPFC. Thirty individuals with PD participated (H&Y stages I-III). All of them were more affected on the right side. Participants were allocated into three groups. The DLPFC group received HF-rTMS over left DLPFC; while, the M1 group received HF-rTMS over left M1 of extensor digitorum communis representational area. The control group received HF-rTMS over the vertex. Before and immediately post HF-rTMS, right-hand RTG performance was measured under no barrier and barrier conditions. Additionally, TMS measures including motor-evoked-potential (MEP) amplitude and cortical silent period (CSP) were determined to verify the effects of HF-rTMS. For the results, there were no significant differences among the three groups. However, only the M1 group showed a significant decrease in movement time immediately after HF-rTMS for a barrier condition. Moreover, the M1 group showed a near-significant increase in hand opening and transport velocity. As for the DLPFC group, there was a near-significant increase in temporal transport-grasp coordination and a significant increase in velocity. Increased MEP amplitudes and a significantly longer CSP in the M1 and DLPFC groups confirmed the effects of HF-rTMS. Regarding non-significant results among the three groups, it is still inconclusive whether there were different effects of the rTMS on the two stimulation areas. This is a preliminary study demonstrating that HF-rTMS to M1 may improve RTG execution; whereas, HF-rTMS to DLPFC may improve visuospatial processing demands of RTG.",2020,Increased MEP amplitudes and a significantly longer CSP in the M1 and DLPFC groups confirmed the effects of HF-rTMS.,"[""Individuals with Parkinson's disease (PD"", ""individuals with Parkinson's disease"", 'Thirty individuals with PD participated (H&Y stages I-III']","['high-frequency repetitive transcranial magnetic stimulation', 'rTMS', 'HF-rTMS']","['TMS measures including motor-evoked-potential (MEP) amplitude and cortical silent period (CSP', 'Increased MEP amplitudes', 'movement time', 'hand opening and transport velocity', 'reach-to-grasp performance', 'RTG performance', 'temporal transport-grasp coordination', 'velocity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",30.0,0.0137685,Increased MEP amplitudes and a significantly longer CSP in the M1 and DLPFC groups confirmed the effects of HF-rTMS.,"[{'ForeName': 'Jenjira', 'Initials': 'J', 'LastName': 'Thanakamchokchai', 'Affiliation': 'Motor Control and Neural Plasticity Laboratory, Faculty of Physical Therapy, Mahidol University, 999 Putthamonthon 4 Road, Salaya, 73170, Nakorn Pathom, Thailand.'}, {'ForeName': 'Jarugool', 'Initials': 'J', 'LastName': 'Tretriluxana', 'Affiliation': 'Motor Control and Neural Plasticity Laboratory, Faculty of Physical Therapy, Mahidol University, 999 Putthamonthon 4 Road, Salaya, 73170, Nakorn Pathom, Thailand. jarugool.tre@mahidol.ac.th.'}, {'ForeName': 'Narawut', 'Initials': 'N', 'LastName': 'Pakaprot', 'Affiliation': 'Department of Physiology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road Bangkoknoi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Apichart', 'Initials': 'A', 'LastName': 'Pisarnpong', 'Affiliation': 'Movement Disorder Clinic, Division of Neurology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road Bangkoknoi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Fisher', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, Southern California University, 1540 Alcazar St., CHP 155, Los Angeles, CA, 90089-9006, USA.'}]",Experimental brain research,['10.1007/s00221-020-05843-6']
2855,32500299,"Changes in spinal bone density, back muscle size, and visceral adipose tissue and their interaction following a multi-component exercise program in older men: secondary analysis of an 18-month randomized controlled trial.","In middle-aged and older men, an 18-month multi-component exercise program improved spinal trabecular BMD, paraspinal, and psoas muscle cross-sectional area (CSA) but not visceral adipose tissue (VAT). However, changes in both muscle and VAT CSA were associated with changes in spinal BMD, independent of the exercise intervention.
INTRODUCTION
In older men, we previously reported that a multi-component exercise program improved lumbar spine (LS) trabecular volumetric BMD (Tb.vBMD) compared with no exercise. This study aimed to investigate the following: (1) the effect of the exercise program on paraspinal and psoas (back) muscle CSA and VAT, and 2) if any exercise-related changes in muscle CSA and/or VAT were associated with changes in spinal BMD.
METHODS
Men (n = 180) aged 50-79 years were randomized to an exercise or no-exercise group. Exercise involved high-intensity progressive resistance training (60-85% max) with weight-bearing impact exercise (3 days/week) for 18 months. Quantitative computed tomography was used to assess L1-L3 Tb.vBMD, paraspinal, and psoas muscle CSA and VAT.
RESULTS
Exercise resulted in a 2.6% ((95% CI, 1.1, 4.1), P < 0.01) net gain in back muscle CSA, but no effect on VAT (-1.6% (95% CI, -7.3, 4.2)) relative to no exercise. Robust regression indicated that percentage changes in Tb.vBMD were positively associated with changes (expressed as z-scores) in back muscle CSA in both the exercise (beta (β)-coefficient = 1.9, 95% CI 0.5, 3.2, P = 0.007) and no-exercise (β = 2.6, 95% CI, 1.1, 4.1, P = 0.001) group, and negatively with the changes in VAT (β = -2.0, 95% CI -3.3, -0.7, P = 0.003) in the exercise only group. There were no group differences in the slopes for the muscle-bone or VAT-bone relationships. Regression analysis (pooled data) revealed that back muscle CSA and VAT were independent predictors of the change in Tb.vBMD, explaining 14% of the variance.
CONCLUSION
A multi-component exercise program in middle-aged and older men improved spinal BMD and back muscle size but not visceral fat. However, changes in back muscle size and VAT were associated with the changes in spinal BMD, independent of exercise.
TRIAL REGISTRATION
ACTRN 12617001224314, 22/08/2017 retrospectively registered.",2020,A multi-component exercise program in middle-aged and older men improved spinal BMD and back muscle size but not visceral fat.,"['Men (n = 180) aged 50-79 years', 'middle-aged and older men', 'older men']","['exercise program', 'Exercise involved high-intensity progressive resistance training (60-85% max) with weight-bearing impact exercise', 'exercise or no-exercise group', 'multi-component exercise program']","['VAT', 'spinal BMD and back muscle size', 'spinal trabecular BMD, paraspinal, and psoas muscle cross-sectional area (CSA', 'lumbar spine (LS) trabecular volumetric BMD (Tb.vBMD', 'Tb.vBMD', 'muscle-bone or VAT-bone relationships', 'spinal bone density, back muscle size, and visceral adipose tissue and their interaction', 'spinal BMD', 'paraspinal and psoas (back) muscle CSA and VAT, and 2', 'net gain in back muscle CSA']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0442145', 'cui_str': 'Paraspinal'}, {'cui': 'C0085221', 'cui_str': 'Structure of psoas muscle'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",180.0,0.0941906,A multi-component exercise program in middle-aged and older men improved spinal BMD and back muscle size but not visceral fat.,"[{'ForeName': 'A-F', 'Initials': 'AF', 'LastName': 'Turcotte', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Centre, Québec City, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kukuljan', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3128, VIC, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dalla Via', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3128, VIC, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gagnon', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Centre, Québec City, Canada.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Abbott', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3128, VIC, Australia.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3128, VIC, Australia. rmdaly@deakin.edu.au.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05484-z']
2856,32500344,Is Postoperative Adjuvant Transcatheter Arterial Infusion Therapy Effective for Patients with Hepatocellular Carcinoma who Underwent Hepatectomy? A Prospective Randomized Controlled Trial.,"BACKGROUND
The effectiveness of adjuvant transcatheter arterial chemo- or/and chemoembolization therapy after curative hepatectomy of initial hepatocellular carcinoma (HCC) is controversial. This study aimed to evaluate whether hepatectomy combined with adjuvant transcatheter arterial infusion therapy (TAI) for initial HCC has better long-term survival outcomes than hepatectomy alone.
METHODS
From January 2012 to December 2014, a prospective randomized controlled trial of patients with initial HCC was conducted. Then, 114 initial HCC patients were recruited to undergo hepatectomy with adjuvant TAI (TAI group, n = 55) or hepatectomy alone (control group, n = 59) at our institution. The TAI therapy was performed twice, at 3 and 6 months after curative hepatectomy (UMIN 000011900).
RESULTS
The patients treated with TAI had no serious side effects, and operative outcomes did not differ between the two groups. No significant differences were found in the pattern of intrahepatic recurrence or time until recurrence between the two groups. Moreover, no significant differences were found in the relapse-free survival or overall survival. Low cholinesterase level (< 200) had been identified as a risk factor affecting relapse-free survival. Furthermore, compared with surgery alone, adjuvant TAI with hepatectomy improved the overall survival for lower-cholinesterase patients.
CONCLUSIONS
Adjuvant TAI is safe and feasible, but it cannot reduce the incidence of postoperative recurrence or prolong survival for patients who underwent curative hepatectomy for initial HCC.",2020,"Furthermore, compared with surgery alone, adjuvant TAI with hepatectomy improved the overall survival for lower-cholinesterase patients.
","['Patients with Hepatocellular Carcinoma who Underwent Hepatectomy', 'curative hepatectomy of initial hepatocellular carcinoma (HCC', '114 initial HCC patients were recruited to undergo', 'patients with initial HCC', 'From January 2012 to December 2014', 'patients who underwent curative hepatectomy for initial HCC']","['hepatectomy combined with adjuvant transcatheter arterial infusion therapy (TAI', 'TAI', 'hepatectomy with adjuvant TAI (TAI group, n\u2009=\u200955) or hepatectomy alone (control group, n\u2009=\u200959) at our institution', 'adjuvant transcatheter arterial chemo- or/and chemoembolization therapy']","['pattern of intrahepatic recurrence or time until recurrence', 'overall survival', 'serious side effects, and operative outcomes', 'relapse-free survival or overall survival', 'Low cholinesterase level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0202207', 'cui_str': 'Cholinesterase measurement'}]",,0.0610251,"Furthermore, compared with surgery alone, adjuvant TAI with hepatectomy improved the overall survival for lower-cholinesterase patients.
","[{'ForeName': 'Fumitoshi', 'Initials': 'F', 'LastName': 'Hirokawa', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan. sur122@osaka-med.ac.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Komeda', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Taniguchi', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Asakuma', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Tetsunosuke', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Kagota', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tomioka', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Radiology, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Uchiyama', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}]",Annals of surgical oncology,['10.1245/s10434-020-08699-w']
2857,32500393,A Habit-Based Randomised Controlled Trial to Reduce Sugar-Sweetened Beverage Consumption: the Impact of the Substituted Beverage on Behaviour and Habit Strength.,"BACKGROUND
Excess sugar consumption has been linked to numerous negative health outcomes, such as obesity and type II diabetes. Reducing sugar-sweetened beverage (SSB) consumption may reduce sugar intake and thus improve health. The aim of the study was to test the impact of the potentially different rewarding nature of water or diet drinks as replacements for SSB, using a habit and implementation intention-based intervention.
METHOD
An online randomised, two-arm parallel design was used. One hundred and fifty-eight participants (mainly from the UK and USA) who regularly consumed SSBs (M age = 31.5, 51% female) were advised to create implementation intentions to substitute their SSB with either water or a diet drink. Measures of SSB consumption, habit strength and hedonic liking were taken at baseline and at 2 months. Water or diet drink consumption was only measured at 2 months.
RESULTS
There was a large and significant reduction in SSB consumption and self-reported SSB habits for both the water and diet drink groups, but no difference between groups. There were no differences in hedonic liking for the alternative drink, alternative drink consumption and alternative drink habit between the two groups. Reduction in SSB hedonic liking was associated with reduced SSB consumption and habit.
CONCLUSION
This study demonstrates that an implementation intention-based intervention achieved substantial reductions in SSB consumption and habits. It also indicates that hedonic liking for SSBs and alternative drinks are associated with changes in consumption behaviour. Substituting SSBs with water or diet drinks was equally as effective in reducing SSB consumption.",2020,"There were no differences in hedonic liking for the alternative drink, alternative drink consumption and alternative drink habit between the two groups.","['One hundred and fifty-eight participants (mainly from the UK and USA) who regularly consumed SSBs (M age \u2009=\u200931.5, 51% female']","['Sugar-Sweetened Beverage Consumption', 'Reducing sugar-sweetened beverage (SSB) consumption', 'SSB with either water or a diet drink', 'water or diet drinks']","['SSB consumption and habit', 'SSB consumption, habit strength and hedonic liking', 'SSB consumption', 'SSB hedonic liking', 'hedonic liking for the alternative drink, alternative drink consumption and alternative drink habit', 'SSB consumption and habits', 'SSB consumption and self-reported SSB habits']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C5197815', 'cui_str': 'Diet Beverages'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",158.0,0.0347568,"There were no differences in hedonic liking for the alternative drink, alternative drink consumption and alternative drink habit between the two groups.","[{'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Judah', 'Affiliation': 'Institute of Global Health Innovation, Department of Surgery & Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mullan', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Kent Street, Bentley, WA, 6102, Australia. barbara.mullan@curtin.edu.au.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Yee', 'Affiliation': 'Institute of Global Health Innovation, Department of Surgery & Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Allom', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Kent Street, Bentley, WA, 6102, Australia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Liddelow', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Kent Street, Bentley, WA, 6102, Australia.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09906-4']
2858,32500449,"An Empirical Comparison of Statistical Methods for Missing Data in Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trials for Chronic Pain and Lipid-Lowering Products.","BACKGROUND
Missing data are uncollected data but meaningful for the statistical analysis due to clinical relevancy of the data for properly specified estimands in clinical trials. Meanwhile the efforts to prevent or minimize missing data are commonly applied in clinical trials, in practice, missing data still occurs. Choosing a statistical method for imputation that deals with missing data targeting specified estimands provides the more reliable estimates of treatment effects.
METHODS
We considered longitudinal clinical settings that have different degrees of missing data and treatment effects, and simulated different missing mechanisms using data from randomized, double-blind, placebo-controlled phase 3 confirmatory clinical trials of approved drugs. We compared four commonly used statistical methods to deal with missing data in clinical trials.
RESULTS
We find that, when the data are missing not at random (MNAR) with higher missing rates, mixed model for repeated measurements (MMRM) method overestimates treatment difference. Pattern-mixture model estimates were seen to be more conservative in our studies than MMRM given MNAR assumptions, which are more realistic with missing data in clinical trials.
CONCLUSIONS
We emphasize the importance of prevention of missing data and specifying the estimand based on trial objectives beforehand. The specified proper estimand and the proper statistical method might be key features to value the clinical trial results despite missing data.",2020,"Choosing a statistical method for imputation that deals with missing data targeting specified estimands provides the more reliable estimates of treatment effects.
",[],"['Placebo', 'placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.409786,"Choosing a statistical method for imputation that deals with missing data targeting specified estimands provides the more reliable estimates of treatment effects.
","[{'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Gnang', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Yoonhee', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. yoonhee.kim@fda.hhs.gov.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Travis', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Yongman', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.'}]",Therapeutic innovation & regulatory science,['10.1007/s43441-020-00168-6']
2859,32493468,"Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES
We will investigate the effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen in COVID-19 in patients that have tested positive and are moderately to severely ill.
TRIAL DESIGN
This is a single center, open label, randomized, controlled, parallel group, clinical trial that will be conducted at Loghman Hakim Medical Education Center in conjunction with Shahid Beheshti University of Medical Sciences.
PARTICIPANTS
Sixty COVID-19 confirmed cases (using the RT-PCR test) will be enrolled in the trial between April 9 th to April 14 th 2020. Patients will be randomly assigned to the intervention groups or the control group with the following eligibility criteria: ≥ 18 years of age AND (oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24) AND at least one of the following: Contactless infrared forehead thermometer temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission, and time of onset of the symptoms should be acute (Days ≤ 14). Although Hydroxychloroquine will be administered in a single dose, patients with heart problems (prolonged QT or PR intervals, second- or third-degree heart block, and arrhythmias including torsade de pointes) will be excluded. Other exclusion criteria include using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a, Interferon-β 1b, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results and refusal to participate. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services.
INTERVENTION AND COMPARATOR
COVID-19 confirmed patients will be randomly assigned to one of three groups, with 20 patients in each. The first group (Arm 1) will receive Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1a (Recigen), the second group (Arm 2) will be administered Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1b (Ziferon), and the control group (Arm 3) will be treated by Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra).
MAIN OUTCOMES
Time to clinical improvement is our primary outcome measure. This is an improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever comes first. Secondary outcomes include mortality from the date of randomization until the last day of the study which will be the day all of the patients have had at least one of the following outcomes: 1) Improvement of two points on a seven-category ordinal scale. 2) Discharge from the hospital 3) Death. If any patient dies, we have reached an important secondary outcome. SpO2 Improvement between the last and first day of hospitalization, using pulse-oximetry. Duration of hospitalization from date of randomization until the date of hospital discharge or date of death from any cause, whichever comes first. Incidence of new mechanical ventilation uses from date of randomization until the last day of the study. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving. Statistical analysis will be performed by R version 3.6.1 software. We will use Kaplan-Meier to analyze the time to clinical improvement (compared with a log-rank test). Hazard ratios with 95% confidence intervals will be calculated using the Cox proportional-hazards model in crude and adjusted analysis.
RANDOMIZATION
Eligible patients will be randomly assigned in a 1:1:1 ratio to receive either Interferon Beta 1a, Interferon Beta 1b or standard care only. Patients will be randomly allocated to three therapeutic arms using permuted, block-randomization to balance the number of patients allocated to each group. The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1. and placed in individual sealed and opaque envelopes by the statistician. The investigator will enroll the patients and only then open envelopes to assign patients to the different treatment groups. This method of allocation concealment will result in minimum selection and confounding biases.
BLINDING (MASKING)
The present research is open-label (no masking) of patients and health care professionals who are undertaking outcome assessment of the primary outcome - time to clinical improvement.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)
Of the 60 patients who underwent randomization, 20 patients were assigned to receive Interferon beta-1a, 20 patients were assigned to receive Interferon beta 1b plus standard care and the rest of patients were assigned to receive the standard care alone.
TRIAL STATUS
Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on 9 th April 2020 and the end date was on 14 th April 2020. Last point of data collection will be the last day on which all of the 60 participants have had an outcome of clinical improvement or death, completing the study's follow-up time window.
TRIAL REGISTRATION
This study was registered with National Institutes of Health Clinical trials (www.clinicaltrials.gov; identification number NCT04343768, registered April 8, 2020 and first available online April 13, 2020).
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1.","['adults with moderate to severe COVID-19', '20 patients', 'patients that have tested positive and are moderately to severely ill', 'Loghman Hakim Medical Education Center in conjunction with Shahid Beheshti University of Medical Sciences', 'registered with National Institutes of Health Clinical trials (www.clinicaltrials.gov; identification number NCT04343768, registered April 8, 2020 and first available online April 13, 2020', 'Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services', 'Sixty COVID-19 confirmed cases (using the RT-PCR test) will be enrolled in the trial between April 9 th to April 14 th 2020', '60 patients who underwent randomization', 'patients with heart problems (prolonged QT or PR intervals, second- or third-degree heart block, and arrhythmias including torsade de pointes']","['Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1a (Recigen', 'Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1b (Ziferon', 'Interferon Beta 1a, Interferon Beta 1b or standard care only', 'Hydroxychloroquine', 'Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a, Interferon-β', 'Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra', 'Interferon beta 1b plus standard care and the rest of patients were assigned to receive the standard care alone', 'Interferon Beta 1a, compared to Interferon Beta', 'Interferon']","['Hazard ratios', 'SpO2 Improvement', 'mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1300638', 'cui_str': 'Identification number'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0429087', 'cui_str': 'PR interval - finding'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040479', 'cui_str': 'Torsades de pointes'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0939357', 'cui_str': 'Kaletra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",20.0,0.114249,"The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1.","[{'ForeName': 'Seyed Sina Naghibi', 'Initials': 'SSN', 'LastName': 'Irvani', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Golmohammadi', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamad Amin', 'Initials': 'MA', 'LastName': 'Pourhoseingholi', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Shokouhi', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ilad Alavi', 'Initials': 'IA', 'LastName': 'Darazam', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. ilad.alavi@sbmu.ac.ir.'}]",Trials,['10.1186/s13063-020-04382-3']
2860,32494210,"Effect of Acupuncture on Pregnancy-Related Insomnia and Melatonin: A Single-Blinded, Randomized, Placebo-Controlled Trial.","Objective
The aim of the current study is to evaluate the efficacy and safety of acupuncture on sleep quality and overnight melatonin secretion, measured as urinary 6-sulfatoxymelatonin, in pregnant women.
Patients and Methods
This randomized, parallel, single-blinded (participant), controlled trial was conducted on 72 pregnant women with insomnia. Study participants were randomly assigned to either the intervention, 10 sessions of acupuncture treatment over a 3-week period, or control group by block randomization (1:1). Patients in both groups were evaluated at baseline and post-treatment (third week) using the Pittsburgh Sleep Quality Index (PSQI) score (as the primary outcome) and urinary 6-sulfatoxymelatonin.
Results
Fifty-five of 72 participants completed the study. There was no statistically significant difference regarding PSQI score and 6-sulfatoxymelatonin level between intervention and control groups at the baseline ( P =0.169 and P =0.496). At the end of the study period, treatment with acupuncture significantly improved the PSQI score ( P <0.001) with a large effect size of 3.7, as well as 6-sulfatoxymelatonin level ( P =0.020) with a medium effect size of 0.6 as compared to the control group. No adverse effects were noted during acupuncture sessions and follow-up visits.
Conclusion
Acupuncture was shown to significantly improve the sleep quality in pregnant women, possibly through increasing melatonin secretion, and could be recommended as a low-cost and low-risk alternative treatment to pharmacological therapies.",2020,There was no statistically significant difference regarding PSQI score and 6-sulfatoxymelatonin level between intervention and control groups at the baseline ( P =0.169 and P =0.496).,"['Fifty-five of 72 participants completed the study', '72 pregnant women with insomnia', 'pregnant women']","['acupuncture', 'Placebo', 'Acupuncture']","['Pittsburgh Sleep Quality Index (PSQI) score', 'sleep quality and overnight melatonin secretion', 'PSQI score and 6-sulfatoxymelatonin level', 'PSQI score', 'efficacy and safety', '6-sulfatoxymelatonin level', 'Pregnancy-Related Insomnia and Melatonin', 'adverse effects', 'sleep quality']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0049713', 'cui_str': '6-sulfatoxymelatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",72.0,0.200747,There was no statistically significant difference regarding PSQI score and 6-sulfatoxymelatonin level between intervention and control groups at the baseline ( P =0.169 and P =0.496).,"[{'ForeName': 'Saeedeh', 'Initials': 'S', 'LastName': 'Foroughinia', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Eastern Health, Victoria, Australia.'}, {'ForeName': 'Mohammadjavad', 'Initials': 'M', 'LastName': 'Hadianfard', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Hajihosseini', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Pirasteh', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Vossoughi', 'Affiliation': 'Oral and Dental Disease Research Center, Department of Dental Public Health, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Doroudchi', 'Affiliation': 'Department of Immunology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rafiee Monjezi', 'Affiliation': 'Shiraz Institute for Cancer Research, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Nature and science of sleep,['10.2147/NSS.S247628']
2861,32494211,Effects of Alpha-Lipoic Acid Supplementation on Cardiovascular Disease Risk Factors in β-Thalassemia Major Patients: A Clinical Trial Crossover Study.,"Aim
Thalassemia is one of the most common genetic diseases, and cardiovascular disease (CVD) has been considered as the leading cause of mortality in more than 50% of β-thalassemia patients. The aim of this study was to determine the effects of alpha-lipoic acid (ALA) on CVD risk factors in β-thalassemia major patients.
Methods
Twenty β-thalassemia major patients participated in this randomized crossover clinical trial study. Participants were randomly assigned to ALA (600 mg/day) or placebo groups for two 8-wk interventions that were separated by a 3-wk washout period. The CVD risk factors including serum osteoprotegerin (OPG), homocysteine, lipoprotein-associated phospholipase A 2 and trimethylamine N -oxide were measured at the beginning and the end of each intervention phase according to the standard protocol.
Results
Serum OPG reduced significantly in the ALA group in all participants (5.38 ± 2.79 to 3.27 ± 2.43 ng/mL, P = .003) and in the male subgroup (5.24 ± 2.56 to 3.13 ± 2.5 ng/mL, P = .015); this reduction was significant in comparison with the placebo group ( P = .013). The changes in other CVD risk factors were not significant.
Conclusion
The results of this study showed that after 8-wk of ALA consumption, the serum OPG reduced significantly in β-thalassemia major patients. Therefore, controlling the serum OPG level with ALA consumption can be an important complementary therapeutic option to prevent the progression of CVD in β-thalassemia major patients.",2020,"The CVD risk factors including serum osteoprotegerin (OPG), homocysteine, lipoprotein-associated phospholipase A 2 and trimethylamine N -oxide were measured at the beginning and the end of each intervention phase according to the standard protocol.
","['β-Thalassemia Major Patients', 'β-thalassemia major patients', 'Methods\n\n\nTwenty β-thalassemia major patients']","['Alpha-Lipoic Acid Supplementation', '\ufeffalpha-lipoic \ufeffacid (ALA', 'ALA', 'placebo']","['serum OPG', 'Cardiovascular Disease Risk Factors', 'Serum OPG', 'CVD risk factors', 'serum osteoprotegerin (OPG), homocysteine, lipoprotein-associated phospholipase A 2 and trimethylamine N -oxide']","[{'cui': 'C0002875', 'cui_str': 'Homozygous beta thalassemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031667', 'cui_str': 'Phospholipase A>2<'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}]",,0.171414,"The CVD risk factors including serum osteoprotegerin (OPG), homocysteine, lipoprotein-associated phospholipase A 2 and trimethylamine N -oxide were measured at the beginning and the end of each intervention phase according to the standard protocol.
","[{'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Jamshidi', 'Affiliation': 'The Student Research Committee, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Abdollahzad', 'Affiliation': 'Nutritional Sciences Department, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Nachvak', 'Affiliation': 'Nutritional Sciences Department, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Golpayegani', 'Affiliation': 'Department of Pediatrics, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Sharifi Zahabi', 'Affiliation': 'Imam Khomeini Comprehensive Health Services Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Journal of blood medicine,['10.2147/JBM.S252105']
2862,32494217,Effect of Reflexology on the Constipation Status of Elderly People.,"Background
The current literature shows that one of the alternative therapies used to control constipation is reflexology. This study was conducted to assess the effect of reflexology on the constipation status of elderly people.
Methods
This study was randomized clinical trial conducted from at the private nursing home in the Ankara Province. At the nursing home, 60 eligible elderly people were randomly assigned into experimental ( n = 30) and control ( n = 30) groups. The experimental group received foot reflexology massage for 1 month three times per week for 30 min. Reflexology was initiated from the patient's right foot. The foot was relaxed primarily by applying effleurage followed by shaking, rotation, and stretching methods. The practice ended by applying solar plexus pressure on both feet. For elderly people in the control group foot surface massage without pressure was applied to simulate the interventions similar to the experimental group. The scale scores before and after reflexology were noted for the experimental group, and those for the control group, which did not receive any reflexology massage, were also determined.
Results
After the implementation of reflexology, the rate of emptying bowels on alternate days increased in the experimental group as opposed to that in the control group ( P < 0.001). In this study, reflexology was found to improve the quality of life of the elderly and decrease the severity of constipation.
Conclusion
Foot reflexology massage was found to be effective in relieving the constipation of elderly people. Therefore, reflexology is recommended as part of nursing care to reduce the constipation status of elderly people.",2020,"In this study, reflexology was found to improve the quality of life of the elderly and decrease the severity of constipation.
","['elderly people', 'Elderly People', 'private nursing home in the Ankara Province', '60 eligible elderly people']","['Foot reflexology massage', 'reflexology', 'foot reflexology massage', 'Reflexology']","['quality of life', 'rate of emptying bowels', 'severity of constipation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0587730', 'cui_str': 'Private nursing home'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",60.0,0.0156769,"In this study, reflexology was found to improve the quality of life of the elderly and decrease the severity of constipation.
","[{'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Inkaya', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Tuzer', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Ankara Yildirim Beyazit University, Ankara, Turkey.'}]",Yonago acta medica,['10.33160/yam.2020.05.007']
2863,32494240,Effects of routine physiotherapy with and without neuromobilization in the management of internal shoulder impingement syndrome: A randomized controlled trial.,"Background & Objective
Routine physiotherapy has been advocated was an effective treatment for internal shoulder impingement syndrome. However, there is lack of best exercise treatment and lots of studies are under consideration. The objective of the study was to compare the effects of Neuromobilization and routine physiotherapy on pain in patients having shoulder internal impingement syndrome.
Methods
This is a single blinded randomized control clinical trial that was conducted at Social Security Hospital Gujranwala in which 80 patients with SIS were participated. The duration of study was from September 2016 to March 2018. Patients were recruited after giving an informed consent and were randomly assigned to either control or experimental group which was treated with routine physiotherapy and routine physiotherapy plus neuromobilization respectively; pain was assessed by Numeric Rating Scale at base line, 5 th and 11 th week.
Results
The experimental group compared with control group at 11 th week had lower mean pain score 2.15(1.66-2.64) vs 4.90(4.41-5.40); between group difference, 1.82; 95% (CI), -2.38 to -1.25; P < 0.001 and Partial Ŋ 2 =0.33. These results show that pain score is much improved in experimental group.
Conclusion
Neuromobilization along with physical therapy is more effective as compared to physiotherapy alone.",2020,"The experimental group compared with control group at 11 th week had lower mean pain score 2.15(1.66-2.64) vs 4.90(4.41-5.40); between group difference, 1.82; 95% (CI), -2.38 to -1.25; P < 0.001 and Partial Ŋ 2 =0.33.","['Patients were recruited after giving an informed consent', 'patients having shoulder internal impingement syndrome', '80 patients with SIS were participated', 'internal shoulder impingement syndrome']","['routine physiotherapy and routine physiotherapy plus neuromobilization respectively; pain', 'Neuromobilization and routine physiotherapy', 'routine physiotherapy with and without neuromobilization']","['pain score', 'Numeric Rating Scale', 'mean pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C4277522', 'cui_str': 'Posterosuperior Glenoid Impingement'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",80.0,0.136786,"The experimental group compared with control group at 11 th week had lower mean pain score 2.15(1.66-2.64) vs 4.90(4.41-5.40); between group difference, 1.82; 95% (CI), -2.38 to -1.25; P < 0.001 and Partial Ŋ 2 =0.33.","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Akhtar', 'Affiliation': 'Dr. Muhammad Akhtar, M.Phil-PT. Department of Physiotherapy, Social Security Hospital, Gujranwala, Pakistan.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Karimi', 'Affiliation': 'Prof. Hossein Karimi, Ph.D-PT. University Institute of Physiotherapy, The University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Syed Amir', 'Initials': 'SA', 'LastName': 'Gilani', 'Affiliation': 'Prof. Syed Amir Gilani, Ph.D Swiss. Dean Faculty of Allied Health Sciences, The University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'Dr. Ashfaq Ahmad, Ph.D-PT. University Institute of Physiotherapy, The University of Lahore, Lahore, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.4.1545']
2864,32494580,Immunogenicity and Reactogenicity of a Reduced Schedule of a 4-component Capsular Group B Meningococcal Vaccine: A Randomized Controlled Trial in Infants.,"Background
The 4-component capsular group B meningococcal vaccine (4CMenB) was licensed as a 4-dose infant schedule but introduced into the United Kingdom as 3 doses at 2, 4, and 12 months of age. We describe the immunogenicity and reactogenicity of the 2 + 1 schedule in infants.
Methods
Infants were randomized to receive 4CMenB with routine immunizations (test group) at 2, 4, and 12 months or 4CMenB alone at 6, 8, and 13 months of age (control group). Serum bactericidal antibody (SBA) assay against a serogroup B meningococcal reference strain (44/76-SL), memory B-cell responses to factor H binding protein, Neisseria adhesion protein A, Neisseria heparin binding antigen, Porin A (PorA), and reactogenicity was measured.
Results
One hundred eighty-seven infants were randomized (test group: 94; control group: 93). In the test group, 4CMenB induced SBA titers above the putative protective threshold (1:4) after primary and booster doses in 97% of participants. Postbooster, the SBA GMT (72.1; 95% confidence interval [CI], 51.7-100.4) was numerically higher than the serum bactericidal antibody geometric mean titre (SBA GMT) determined post-primary vaccination (48.6; 95% CI, 37.2-63.4). After primary immunizations, memory B-cell responses did not change when compared with baseline controls, but frequencies significantly increased after booster. Higher frequency of local and systemic adverse reactions was associated with 4CMenB.
Conclusions
A reduced schedule of 4CMenB was immunogenic and established immunological memory after booster.",2020,"After primary immunizations, memory B-cell responses did not change when compared with baseline controls, but frequencies significantly increased after booster.","['Infants', 'One hundred eighty-seven infants', 'infants']","['4-component Capsular Group B Meningococcal Vaccine', '4CMenB with routine immunizations', '4-component capsular group B meningococcal vaccine (4CMenB']","['serum bactericidal antibody geometric mean titre (SBA GMT', 'SBA titers', 'immunogenicity and reactogenicity', 'Immunogenicity and Reactogenicity', 'Serum bactericidal antibody (SBA) assay against a serogroup B meningococcal reference strain (44/76-SL), memory B-cell responses', 'memory B-cell responses', 'heparin binding antigen, Porin A (PorA), and reactogenicity', 'Higher frequency of local and systemic adverse reactions']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517895', 'cui_str': '87'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C1259712', 'cui_str': 'VDAC1 protein, human'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",187.0,0.113395,"After primary immunizations, memory B-cell responses did not change when compared with baseline controls, but frequencies significantly increased after booster.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Valente Pinto', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Galal', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Camara Pellisso', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Hughes', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kerridge', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Findlow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa143']
2865,32494763,The effectiveness of counseling based on acceptance and commitment therapy on body image and self-esteem in polycystic ovary syndrome: An RCT.,"Background
Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders known with irregular menstruation, hirsutism, alopecia, obesity, infertility, and acne. These symptoms cause a negative effect on the satisfaction of body image, self-esteem, and quality of life in such patients. Recent studies emphasize the need to consider the psychological problems in these women and also the need for appropriate interventions.
Objective
The aim of this study was to determine the effectiveness of group counseling based on acceptance and commitment therapy (ACT) on body image and self-esteem in patients with PCOS.
Materials and Methods
In this randomized controlled trial, 52 women with PCOS were randomly allocated to intervention and control groups (n = 26/each) using the table of random numbers. Group counseling based on the ACT was held in eight sessions of 90 min once a week for the intervention group. The demographic questionnaire, Littleton development of the body image concern inventory and Rosenberg self-esteem scale were completed in both groups before, immediately after, and one month after the intervention.
Results
The mean scores of body image concern (p = 0.001) and self-esteem (p ≤ 0.001) in the intervention group after the intervention and follow-up were significantly different from the control group.
Conclusion
Based on the findings of this study, use of cognitive-behavioral therapies in health care centers is recommended as a complementary method.",2020,"The mean scores of body image concern (p = 0.001) and self-esteem (p ≤ 0.001) in the intervention group after the intervention and follow-up were significantly different from the control group.
","['health care centers', 'polycystic ovary syndrome', 'patients with PCOS', '\n\n\nPolycystic ovary syndrome (PCOS', '52 women with PCOS']","['cognitive-behavioral therapies', 'group counseling based on acceptance and commitment therapy (ACT']","['satisfaction of body image, self-esteem, and quality of life', 'mean scores of body image concern', 'self-esteem', 'demographic questionnaire, Littleton development of the body image concern inventory and Rosenberg self-esteem scale', 'body image and self-esteem']","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}]",52.0,0.0844013,"The mean scores of body image concern (p = 0.001) and self-esteem (p ≤ 0.001) in the intervention group after the intervention and follow-up were significantly different from the control group.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moradi', 'Affiliation': 'Student Research Committee, Faculty of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Ghadiri-Anari', 'Affiliation': 'Department of Internal Medicine, Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dehghani', 'Affiliation': 'Department of Biostatistics and Epidemiology, Public Health School, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Reza Vaziri', 'Affiliation': 'Clinical Psychologist, Private Counseling Center of Negaresh, Yazd, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Enjezab', 'Affiliation': 'Department of Midwifery, Research Center for Nursing and Midwifery Care, Faculty of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i4.6887']
2866,32494767,Effect of adding letrozole to gonadotropin on in vitro fertilization outcomes: An RCT.,"Background
Aromatase inhibitors prevent the aromatization of androgens into estrogens, which reduces the negative feedback of estrogen on the hypothalamic-pituitary axis. It is clear that increasing the secretion of follicle-stimulating hormones results in an increased follicular growth.
Objective
This study aimed to evaluate the effect of adding letrozole to gonadotropin on in vitro fertilization outcomes in normal responders.
Materials and Methods
In this randomized clinical trial, 100 normal responder women candidate for controlled ovarian stimulation were randomly enrolled in two groups (n = 50/each). In the case group letrozole was added to gonadotropin in the antagonist protocol. The control group received the conventional antagonist protocol. The main outcome was clinical and chemical pregnancy; and the second outcomes were the number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins.
Results
Basic clinical and demographic features were comparable between the groups. Estradiol level on the day of human-chorionic-gonadotropin administration and the total gonadotropin consumption were significantly higher in the control group than the case group (p = 0.045). In addition, the number of MII oocytes was higher (but not significantl) in the case group than the control group (p = 0.09). Moreover, the endometrial thickness was significantly lower in the case group. There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups.
Conclusion
Although adding letrozole to gonadotropin in normal responders reduces the total dose of gonadotropin, it does not improve the pregnancy outcomes.",2020,"There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups.
","['normal responders', '100 normal responder women candidate for controlled ovarian stimulation']","['letrozole to gonadotropin', 'letrozole', 'conventional antagonist protocol']","['number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins', 'Estradiol level', 'fertilization rate and chemical and clinical pregnancy rates', 'vitro fertilization outcomes', 'total gonadotropin consumption', 'endometrial thickness', 'number of MII oocytes']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",100.0,0.0569174,"There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Eftekhar', 'Affiliation': 'Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Saeed', 'Affiliation': 'Afzalipour Hospital, Kerman University of Medical Science, Kerman, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i4.6891']
2867,32498113,"Pharmacokinetics, safety, and bioequivalence of two empagliflozin formulations after single oral administration under fasting and fed conditions in healthy Chinese subjects: an open-label, randomized, single-dose, 2-sequnce, 2-treatment, 2-period, crossover study.","OBJECTIVES
To evaluate the pharmacokinetic properties and safety of empagliflozin, and bioequivalence of test formulation empagliflozin tablet compared with the brand-name drug Jardiance ® (reference formulation) after single oral administration under fasting and fed conditions in healthy Chinese subjects.
METHODS
An open-label, randomized, single-dose, 2-sequence, 2-treatment, 2-period, crossover study was conducted in healthy Chinese subjects, with 30 subjects under fasting condition and another 30 subjects under fed condition. Under each condition, subjects received a single oral administration of either the test or reference empagliflozin formulation, and then received a single oral dose of the other formulation after a 7-day washout period.
RESULTS
29 subjects under each condition completed the study. The maximum plasma concentration (C max ), the area under the plasma concentration-time curve (AUC) from 0 to t (AUC 0-t ), and the AUC from 0 to infinity (AUC 0-∞ ) of test formulation and reference formulation was 186.90 ± 47.21 and 190.60 ± 40.94 ng/mL, 1303.04 ± 234.28 and 1267.78 ± 217.07 ng·h/mL, and 1328.08 ± 243.84 and 1293.22 ± 224.82 ng·h/mL under fasting condition, and 151.55 ± 23.86 and 154.08 ± 30.40 ng/mL, 1215.65 ± 197.62 and 1199.26 ± 186.23 ng·h/mL, and 1241.76 ± 202.47 and 1225.54 ± 192.10 ng·h/mL under fed condition, respectively.
CONCLUSIONS
The two formulations of empagliflozin were bioequivalent, and both were generally well tolerated under fasting and fed conditions.",2020,"The maximum plasma concentration (C max ), the area under the plasma concentration-time curve (AUC) from 0 to t (AUC 0-t ), and the AUC from 0 to infinity (AUC 0-∞ ) of test formulation and reference formulation was 186.90 ± 47.21 and 190.60 ± 40.94 ng/mL, 1303.04 ± 234.28 and 1267.78 ± 217.07 ng·h/mL, and 1328.08 ± 243.84 and 1293.22 ± 224.82 ng·h/mL under fasting condition, and 151.55 ± 23.86 and 154.08 ± 30.40 ng/mL, 1215.65 ± 197.62 and 1199.26 ± 186.23 ng·h/mL, and 1241.76 ± 202.47 and 1225.54 ± 192.10 ng·h/mL under fed condition, respectively.
","['29 subjects under each condition completed the study', 'healthy Chinese subjects', 'healthy Chinese subjects, with 30 subjects under fasting condition and another 30 subjects under fed condition']","['empagliflozin formulations', 'empagliflozin formulation', 'empagliflozin']","['maximum plasma concentration (C max ), the area under the plasma concentration-time curve (AUC', 'Pharmacokinetics, safety, and bioequivalence']","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",30.0,0.0489666,"The maximum plasma concentration (C max ), the area under the plasma concentration-time curve (AUC) from 0 to t (AUC 0-t ), and the AUC from 0 to infinity (AUC 0-∞ ) of test formulation and reference formulation was 186.90 ± 47.21 and 190.60 ± 40.94 ng/mL, 1303.04 ± 234.28 and 1267.78 ± 217.07 ng·h/mL, and 1328.08 ± 243.84 and 1293.22 ± 224.82 ng·h/mL under fasting condition, and 151.55 ± 23.86 and 154.08 ± 30.40 ng/mL, 1215.65 ± 197.62 and 1199.26 ± 186.23 ng·h/mL, and 1241.76 ± 202.47 and 1225.54 ± 192.10 ng·h/mL under fed condition, respectively.
","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Zang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Zejuan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Zhen', 'Affiliation': 'GCP Office, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Beijing Sun-Novo Pharmaceutical Research Co., Ltd, Building #7, Zhongke Yungu, No. 79, Shuang Ying West Road, Changping District, Beijing, 102200, P.R. China.'}, {'ForeName': 'Shuya', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""President's office, Aerospace 731 hospital, No. 3, Yungang Nanli, Yungang Road, Fengtai District, Beijing, 100074, P.R. China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, 15 Yuquan Road, Haidian District, Beijing, 100049, P.R. China.'}]",Pharmacotherapy,['10.1002/phar.2432']
2868,32498216,Difensil Immuno Reduces Recurrence and Severity of Tonsillitis in Children: A Randomized Controlled Trial.,"Oral supplements (OS) support the immune system in fighting upper airways infection. This study aimed to analyze the effect of Difensil Immuno (DI) on the recurrence of tonsillitis and fever in children. A multicentric randomized clinical trial was conducted. One-hundred and twenty children with chronic tonsillitis were randomly assigned to group A, B or control. Patients in group A were treated with 10 mL of DI for 90 consecutive days, patients in group B underwent treatment with 15 mL of DI for 45 consecutive days. The following data were collected at baseline (T0), T1 and T2: tonsillitis and fever episodes, tonsillar volume, blood test results. One-way ANOVA was used to analyze within and between variances. Patients in group A and B statistically improved their clinical parameters (episode of tonsillitis and fever, tonsillar volume) when compared to control group both at T1 and T2. However, T1 variances were more consistent in group A than in group B. All patients in the study groups improved their clinical outcomes. No statistically significant variances were observed in blood parameters both at T1 and T2. Our results suggest that children treated with DI had fewer episodes of tonsillitis and fever and a reduction in their tonsillar volume.",2020,"Patients in group A and B statistically improved their clinical parameters (episode of tonsillitis and fever, tonsillar volume) when compared to control group both at T1 and T2.","['tonsillitis and fever in children', 'Children', 'One-hundred and twenty children with chronic tonsillitis']","['Difensil Immuno', 'Difensil Immuno (DI', 'Oral supplements (OS']","['episodes of tonsillitis and fever', 'blood parameters', 'T1 and T2: tonsillitis and fever episodes, tonsillar volume, blood test results', 'Recurrence and Severity of Tonsillitis', 'clinical parameters (episode of tonsillitis and fever, tonsillar volume']","[{'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0149517', 'cui_str': 'Chronic tonsillitis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",120.0,0.0380602,"Patients in group A and B statistically improved their clinical parameters (episode of tonsillitis and fever, tonsillar volume) when compared to control group both at T1 and T2.","[{'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Di Stadio', 'Affiliation': 'Department of Otolaryngology, University of Perugia, 06129 Perugia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Della Volpe', 'Affiliation': ""Otology and Cochlear Implant Unit, Santobono-Pausilipon Children's Hospital, 80129 Naples, Italy.""}, {'ForeName': 'Fiammetta M', 'Initials': 'FM', 'LastName': 'Korsch', 'Affiliation': ""Otology and Cochlear Implant Unit, Santobono-Pausilipon Children's Hospital, 80129 Naples, Italy.""}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'De Lucia', 'Affiliation': ""Otology and Cochlear Implant Unit, Santobono-Pausilipon Children's Hospital, 80129 Naples, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Sense Organs Department, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Martines', 'Affiliation': 'Biomedicine, Neuroscience and Advanced Diagnostics Department, University of Palermo, 90127 Palermo, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Ricci', 'Affiliation': 'Department of Otolaryngology, University of Perugia, 06129 Perugia, Italy.'}]",Nutrients,['10.3390/nu12061637']
2869,32498240,An Integrative Neuro-Psychotherapy Treatment to Foster the Adjustment in Acquired Brain Injury Patients-A Randomized Controlled Study.,"Adjustment disorders (AjD) with depressive symptoms following an acquired brain injury (ABI) is a common phenomenon. Although brain injuries are increasing more and more, research on psychological therapies is comparably scarce. The present study compared, by means of a randomized controlled trial (RCT), a newly developed integrative treatment (Standard PLUS) to a standard neuropsychological treatment (Standard). Primary outcomes were depressive symptoms assessed with the Beck Depression Inventory (BDI-II) at post-treatment and 6-month follow-up assessment. In total, 25 patients (80% after a stroke) were randomized to one of the two conditions. Intention-to-treat analyses showed that the two groups did not significantly differ either at post-treatment nor at follow-up assessment regarding depressive symptoms. Both treatments showed large within-group effect sizes on depressive symptoms. Regarding secondary outcomes, patients in the Standard PLUS condition reported more emotion regulation skills at post-assessment than in the control condition. However, this difference was not present anymore at follow-up assessment. Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI. More research with larger samples is needed to investigate who profits from which intervention.",2020,Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI.,"['Adjustment disorders (AjD) with depressive symptoms following an acquired brain injury (ABI', '25 patients (80% after a stroke', 'patients suffering from an AjD after ABI']",['Integrative Neuro-Psychotherapy Treatment'],"['emotion regulation skills', 'depressive symptoms', 'depressive symptoms assessed with the Beck Depression Inventory (BDI-II']","[{'cui': 'C0001546', 'cui_str': 'Adjustment disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}]",25.0,0.128683,Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Urech', 'Affiliation': 'Department of Neurology, Inselspital Bern, Bern University Hospital, 3010 Bern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Psychology, University of Bern, 3012 Bern, Switzerland.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Frischknecht', 'Affiliation': 'Department of Psychology, University of Bern, 3012 Bern, Switzerland.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Stalder-Lüthy', 'Affiliation': 'Department of Neurology, Spitalzentrum Biel, 2501 Biel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grosse Holtforth', 'Affiliation': 'Department of Psychology, University of Bern, 3012 Bern, Switzerland.'}, {'ForeName': 'René Martin', 'Initials': 'RM', 'LastName': 'Müri', 'Affiliation': 'Department of Neurology, Inselspital Bern, Bern University Hospital, 3010 Bern, Switzerland.'}, {'ForeName': 'Hansjörg', 'Initials': 'H', 'LastName': 'Znoj', 'Affiliation': 'Department of Psychology, University of Bern, 3012 Bern, Switzerland.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Hofer', 'Affiliation': 'Department of Neurology, Inselspital Bern, Bern University Hospital, 3010 Bern, Switzerland.'}]",Journal of clinical medicine,['10.3390/jcm9061684']
2870,32498248,Ubiquinol-10 Intake Is Effective in Relieving Mild Fatigue in Healthy Individuals.,"Our double-blind, placebo-controlled study evaluated effects of ubiquinol, the reduced form of coenzyme Q 10 , on mild fatigue in healthy individuals experiencing fatigue in daily life that had continued for more than 1 and less than 6 months. The participants received 100-mg/day (Ubq100; age 44.0 ± 9.8 years; 14 females and 6 males) or 150-mg/day ubiquinol (Ubq150; age 40.4 ± 11.8 years; 14 females and 8 males) or placebo (Plc; age 41.3 ± 13.4 years; 13 females and 7 males) daily for 12 weeks. Measurements of subjective and objective fatigue were conducted by using questionnaires-based fatigue scales/visual analogue scales and autonomic nerve function/biological oxidation index, respectively, prior to the first dosing and every 4 weeks thereafter. Serum ubiquinol level increased three- to four-fold after 4 weeks and remained significantly higher than that after Plc administration throughout the intake period. Although a higher blood level of ubiquinol was observed with Ubq150 than with Ubq100, the difference was not statistically significant. In both Ubq100 and Ubq150 groups, subjective levels of fatigue sensation and sleepiness after cognitive tasks, which consisted of the modified Advanced Trail Making Test, the modified Stroop Color-Word Test, and the Digit Symbol Substitution Test, improved significantly compared with those in the placebo group, suggesting an anti-fatigue effect. The Ubq150 group demonstrated significant improvement compared with the Plc group regarding subjective level of relaxation after task, sleepiness before and after task, motivation for task, and serum level of oxidative stress. Correlation analysis between blood level of ubiquinol and each evaluated effect suggested a positive relationship with relaxation after task, motivation for cognitive task, and parasympathetic activity. The results of the study suggest that ubiquinol intake relieves mild fatigue in healthy individuals.",2020,"The Ubq150 group demonstrated significant improvement compared with the Plc group regarding subjective level of relaxation after task, sleepiness before and after task, motivation for task, and serum level of oxidative stress.","['healthy individuals experiencing fatigue in daily life that had continued for more than 1 and less than 6 months', 'healthy individuals', 'Healthy Individuals', 'Plc; age 41.3 ± 13.4 years; 13 females and 7 males) daily for 12 weeks', 'participants received 100-mg/day (Ubq100; age 44.0 ± 9.8 years; 14 females and 6 males) or 150-mg/day ubiquinol (Ubq150; age 40.4 ± 11.8 years; 14 females and 8 males) or']","['ubiquinol intake', 'Ubiquinol-10 Intake', 'placebo']","['subjective level of relaxation after task, sleepiness before and after task, motivation for task, and serum level of oxidative stress', 'subjective levels of fatigue sensation and sleepiness', 'blood level of ubiquinol', 'Serum ubiquinol level', 'relaxation after task, motivation for cognitive task, and parasympathetic activity', 'mild fatigue', 'Measurements of subjective and objective fatigue', 'questionnaires-based fatigue scales/visual analogue scales and autonomic nerve function/biological oxidation index', 'modified Stroop Color-Word Test, and the Digit Symbol Substitution Test']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0077656', 'cui_str': 'ubiquinol'}]","[{'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0077659', 'cui_str': 'ubiquinol-10'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0206250', 'cui_str': 'Autonomic nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582675', 'cui_str': 'Stroop neuropsychological screening test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0818902,"The Ubq150 group demonstrated significant improvement compared with the Plc group regarding subjective level of relaxation after task, sleepiness before and after task, motivation for task, and serum level of oxidative stress.","[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Mizuno', 'Affiliation': 'Osaka City University Center for Health Science Innovation, Osaka 530-0011, Japan.'}, {'ForeName': 'Akihiro T', 'Initials': 'AT', 'LastName': 'Sasaki', 'Affiliation': 'Osaka City University Center for Health Science Innovation, Osaka 530-0011, Japan.'}, {'ForeName': 'Kyosuke', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Osaka City University Center for Health Science Innovation, Osaka 530-0011, Japan.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Osaka City University Center for Health Science Innovation, Osaka 530-0011, Japan.'}]",Nutrients,['10.3390/nu12061640']
2871,32499026,Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial.,"OBJECTIVES
The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES).
BACKGROUND
Emerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and efficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes.
METHODS
BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-specified 3-year clinical outcomes was performed.
RESULTS
Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, significant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. Definite or probable late or very late stent thrombosis was significantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.
CONCLUSIONS
In a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946).",2020,"Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.
","['1,334 patients randomized to treatment with', 'patients treated with', 'Subjects With Coronary Artery Lesions [BIOFLOW-V', 'Subjects']","['BP SES versus DP EES', 'DP EES', 'Versus Thin Durable-Polymer Everolimus-Eluting Stents', 'ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES', 'ultrathin-strut drug-eluting stents', 'Orsiro Sirolimus Eluting Coronary Stent System', 'Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents', 'BP SES', 'coronary revascularization with BP SES and DP EES']","['Definite or probable late or very late stent thrombosis', '3-year rate of target lesion failure', 'Safety and Effectiveness', 'target vessel myocardial infarction (MI', 'clinically driven target lesion revascularization', 'Cardiac death or MI rates', 'target vessel MI and target lesion revascularization', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]","[{'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}]",1334.0,0.0649538,"Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.
","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org.'}, {'ForeName': 'Jacques J', 'Initials': 'JJ', 'LastName': 'Koolen', 'Affiliation': 'Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Gheorghe', 'Initials': 'G', 'LastName': 'Doros', 'Affiliation': 'Department of Biostatistics and Epidemiology, Boston University School of Public Health, Baim Institute for Clinical Research, Boston, Massachusetts.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Roguin', 'Affiliation': 'Department of Cardiology, Hillel Yaffe Medical Center, Hadera, Israel.'}, {'ForeName': 'Elie G', 'Initials': 'EG', 'LastName': 'Gharib', 'Affiliation': 'Charleston Area Medical Center, Charleston, West Virginia.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Cutlip', 'Affiliation': 'Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, Massachusetts.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.02.019']
2872,32499064,Serostatus cutoff levels and fold increase to define seroresponse to recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein vaccine: An evidence-based analysis.,"The recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein (rVSVΔG-ZEBOV-GP) vaccine is a live recombinant vesicular stomatitis virus (VSV) where the VSV G protein is replaced with ZEBOV-GP. To better understand the immune response after receiving the rVSVΔG-ZEBOV-GP vaccine, the current analyses evaluated different definitions of seroresponse that differentiate vaccine and placebo recipients enrolled in a placebo-controlled clinical trial (PREVAIL; NCT02344407) in which a subset of the study participants had elevated baseline titers. Alternative values for serostatus cutoff (SSCO; 200-500 EU/mL) and/or fold rise (two- to five-fold) were applied to compare their ability to distinguish between participants receiving rVSVΔG-ZEBOV-GP or placebo. The results indicate that an SSCO of 200 EU/mL can be used to define seropositivity at baseline (i.e. pre-vaccination). The use of dual criteria of the same SSCO (200 EU/mL) together with a two-fold rise in antibody level from baseline provided the definition of seroresponse that maximized the statistical significance between vaccine recipients and placebo recipients post-vaccination. Clinical trial registration: NCT02344407.",2020,The recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein,[],"['rVSVΔG-ZEBOV-GP or placebo', 'glycoprotein vaccine', 'rVSVΔG-ZEBOV-GP vaccine', 'rVSVΔG-ZEBOV-GP) vaccine', 'recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein', 'placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042587', 'cui_str': 'Vesicular stomatitis Indiana virus'}, {'cui': 'C0949896', 'cui_str': 'Zaire virus'}]",[],,0.221722,The recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Antonello', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: joseph_antonello@merck.com.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Grant-Klein', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: rebecca.klein1@merck.com.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Nichols', 'Affiliation': 'Crozet BioPharma LLC., Devens, MA, USA. Electronic address: rick.nichols@crozetbiopharma.com.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kennedy', 'Affiliation': 'Partnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia. Electronic address: sbkennedy4@aol.com.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Dubey', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: sheri_dubey@merck.com.'}, {'ForeName': 'Jakub K', 'Initials': 'JK', 'LastName': 'Simon', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: jakub.simon@merck.com.'}]",Vaccine,['10.1016/j.vaccine.2020.04.061']
2873,32499069,"Osteosynthesis of Phalangeal Fractures: Biomechanical Comparison of Kirschner Wires, Plates, and Compression Screws.","PURPOSE
The aim of this study was to compare several osteosynthesis techniques (intramedullary headless compression screws, T-plates, and Kirschner wires) for distal epiphyseal fractures of proximal phalanges in a human cadaveric model.
METHODS
A total of 90 proximal phalanges from 30 specimens (index, ring, and middle fingers) were used for this study. After stripping off all soft tissue, a transverse distal epiphyseal fracture was simulated at the proximal phalanx. The 30 specimens were randomly assigned to 1 fixation technique (30 per technique), either a 3.0-mm intramedullary headless compression screw, locking plate fixation with a 2.0-mm T-plate, or 2 oblique 1.0-mm Kirschner wires. Displacement analysis (bending, distraction, and torsion) was performed using optical tracking of an applied random speckle pattern after osteosynthesis. Biomechanical testing was performed with increasing cyclic loading and with cyclic load to failure using a biaxial torsion-tension testing machine.
RESULTS
Cannulated intramedullary compression screws showed significantly less displacement at the fracture site in torsional testing. Furthermore, screws were significantly more stable in bending testing. Kirschner wires were significantly less stable than plating or screw fixation in any cyclic load to failure test setup.
CONCLUSIONS
Intramedullary compression screws are a highly stable alternative in the treatment of transverse distal epiphyseal phalangeal fractures. Kirschner wires seem to be inferior regarding displacement properties and primary stability.
CLINICAL RELEVANCE
Fracture fixation of phalangeal fractures using plate osteosynthesis may have the advantage of a very rigid reduction, but disadvantages such as stiffness owing to the more invasive surgical approach and soft tissue irritation should be taken into account. Headless compression screws represent a minimally invasive choice for fixation with good biomechanical properties.",2020,"Kirschner wires were significantly less stable than plating or screw fixation in any cyclic load to failure test setup.
","['30 specimens', 'transverse distal epiphyseal phalangeal fractures', 'distal epiphyseal fractures of proximal phalanges in a human cadaveric model', 'A total of 90 proximal phalanges from 30 specimens (index, ring, and middle fingers']","['plating or screw fixation', 'plate osteosynthesis', 'Intramedullary compression screws', 'fixation technique (30 per technique), either a 3.0-mm intramedullary headless compression screw, locking plate fixation with a 2.0-mm T-plate, or 2 oblique 1.0-mm Kirschner wires', 'Cannulated intramedullary compression screws', 'several osteosynthesis techniques (intramedullary headless compression screws, T-plates, and Kirschner wires', 'Kirschner Wires, Plates, and Compression Screws']","['Displacement analysis (bending, distraction, and torsion']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C4087378', 'cui_str': 'Digital fracture'}, {'cui': 'C0476159', 'cui_str': 'Epiphyseal fracture'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0223792', 'cui_str': 'Bone structure of phalanx of finger'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0230393', 'cui_str': 'Middle finger structure'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4727954', 'cui_str': 'Plate osteosynthesis'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011119', 'cui_str': 'Bends'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}]",90.0,0.0130479,"Kirschner wires were significantly less stable than plating or screw fixation in any cyclic load to failure test setup.
","[{'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Rausch', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Harbrecht', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany; Department of Anatomy I, Faculty of Medicine, University of Cologne, Cologne, Germany. Electronic address: andreas.harbrecht@uk-koeln.de.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Kahmann', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany; Institute of Bioengineering, FH Aachen University of Applied Sciences, Jülich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fenten', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Jovanovic', 'Affiliation': 'Department of Trauma and Orthopedics, Hand and Microsurgery Unit, Rashid Hospital, Dubai Health Authority, Oud Metha, Dubai.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hackl', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}, {'ForeName': 'Lars P', 'Initials': 'LP', 'LastName': 'Müller', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Staat', 'Affiliation': 'Institute of Bioengineering, FH Aachen University of Applied Sciences, Jülich, Germany.'}, {'ForeName': 'Kilian', 'Initials': 'K', 'LastName': 'Wegmann', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2020.04.010']
2874,32499108,A comparison of chemo-free strategy with G-CSF plus plerixafor on demand versus intermediate-dose cyclophosphamide and G-CSF as PBSC mobilization in newly diagnosed multiple myeloma patients: An Italian explorative cost Analysis.,"BACKGROUND
Upfront single or tandem ASCT still represents an integral part of treatment for patients with multiple myeloma. The combination of intermediate dose (ID) - cyclophosphamide plus G-CSF, has been considered the standard method as mobilization regimen. No prospective randomized clinical trials have compared efficacy and costs using ID - cyclophosphamide against a chemo-free mobilization strategy with G-CSF and plerixafor on demand.
METHODS
A prospective single arm of 20 patients enrolled in three Italian Centers mobilized with G-CSF plus plerixafor on demand was compared with a retrospective historical control arm of 30 patients mobilized with ID - cyclophosphamide (4 g/sqm) and G-CSF. Costs of the prospective arm was compared with the ones of the retrospective control arm with the aim to collect ≥4 × 10 6 /kg CD34 + . The exploratory cost analysis was performed using microcosting specific inputs of G-CSF plus plerixafor on demand versus ID - cyclophosphamide + G-CSF considering pre-apheresis, peri-apheresis and post-apheresis session.
RESULTS
Mobilization with ID - cyclophosphamide and G-CSF resulted in a significantly higher CD34+ peak mean on day 1 yield (119 CD34+ μL vs 67.3; p = 0.06) and in total average CD34+ yield (mean collection 10.6 × 10 6 /kg vs 5.8 × 10 6 /kg; p = 0.004) compared to patients mobilized with G-CSF and plerixafor. There was no significant differences (p = 0.36) in the two groups of patients collecting ≥ 4 million CD34+/Kg with ID - cyclophosphamide and G-CSF (93.3 %) vs G-CSF and plerixafor (90.0 %). None of the patients undergoing G-CSF and plerixafor mobilization had febrile neutropenia compared with 7 patients who received ID - cyclophosphamide and G-CSF (0% vs 23 %, p = 0.03) who had a median of 5 days hospitalization (range 4-6). All patients proceeded to ASCT with a mean of 3.6 CD34+/kg infused for G-CSF and plerixafor arm and 4.4 CD34+/kg for the ID - cyclophosphamide + GCSF group (p = 0.37) with a median time to ANC and PLT engraftment not different in the two groups. Total costs of a mobilizing strategy using a combination of G-CSF and plerixafor on demand was 12.690 euros compared to 16.088 euros with ID - cyclophosphamide and G-CSF (p = 0.07); in particular, mobilization cost components were significantly lower for G-CSF and plerixafor vs G-CSF and ID - cyclophosphamide for hospital stay (3080 euros vs 9653 euros; p < 0.001) whereas for mobilizing agent, there was a significative difference with 5470 euros for G-CSF and plerixafor use due to the cost of plerixafor compared with 1140 euros for ID - cyclophosphamide and G-CSF treatment (P = 0.001).
CONCLUSIONS
Our data demonstrate that in patients with multiple myeloma eligible for ASCT, a chemo-free mobilization with G-CSF and plerixafor on demand is associated with efficacy in PBSC collection and optimal safety profile with similar average costs when compared to a chemo-mobilization with ID - cyclophosphamide. A prospective randomized multicenter study could address which is the most cost-effective strategy for this setting of patients.
CLINICAL TRIAL REGISTRY
Eudract Number EudraCT 2013-004690-27.",2020,There was no significant differences (p = 0.36) in the two groups of patients collecting ≥ 4 million CD34+/Kg with ID - cyclophosphamide and G-CSF (93.3 %) vs G-CSF and plerixafor (90.0 %).,"['on demand was compared with a retrospective historical control arm of 30 patients mobilized with', 'patients with multiple myeloma', 'newly diagnosed multiple myeloma patients', 'patients with multiple myeloma eligible for', '20 patients enrolled in three Italian Centers mobilized with']","['cyclophosphamide', 'G-CSF and plerixafor', 'plerixafor', 'cyclophosphamide plus G-CSF', 'ID - cyclophosphamide', 'cyclophosphamide + GCSF', 'cyclophosphamide + G-CSF considering pre-apheresis, peri-apheresis and post-apheresis session', 'ASCT', 'ID - cyclophosphamide (4 g/sqm) and G-CSF', 'G-CSF plus plerixafor', 'cyclophosphamide and G-CSF']","['febrile neutropenia', 'mobilization cost components', 'CD34+ peak mean', 'Total costs', 'hospital stay', 'total average CD34+ yield']","[{'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005791', 'cui_str': 'Apheresis'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0054953', 'cui_str': 'Lymphocyte antigen CD34'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0296576,There was no significant differences (p = 0.36) in the two groups of patients collecting ≥ 4 million CD34+/Kg with ID - cyclophosphamide and G-CSF (93.3 %) vs G-CSF and plerixafor (90.0 %).,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Laszlo', 'Affiliation': 'Unità Di Mobilizzazione e Raccolta CSE, Divisione Di Laboratorio Di Ematoncologia Clinica, Istituto Europeo Di Oncologia IRCCS- Milano, Italy. Electronic address: daniele.laszlo@ieo.it.'}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Marcacci', 'Affiliation': 'SS UTIE e Trapianto CSE, Dipartimento Ematologico, IRCCS, Istituto Nazionale Dei Tumori Fondazione ""Sen G. Pascale"" - Napoli, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martino', 'Affiliation': 'UOC Centro Trapianti Midollo Osseo, Grande Ospedale BMM - Reggio Calabria, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Radice', 'Affiliation': 'Divisione Di Epidemiologia e Biostatistica, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rabascio', 'Affiliation': 'Unità Di Mobilizzazione e Raccolta CSE, Divisione Di Laboratorio Di Ematoncologia Clinica, Istituto Europeo Di Oncologia IRCCS- Milano, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lucchetti', 'Affiliation': 'Unità Di Mobilizzazione e Raccolta CSE, Divisione Di Laboratorio Di Ematoncologia Clinica, Istituto Europeo Di Oncologia IRCCS- Milano, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Magarò', 'Affiliation': 'Unità Di Mobilizzazione e Raccolta CSE, Divisione Di Laboratorio Di Ematoncologia Clinica, Istituto Europeo Di Oncologia IRCCS- Milano, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caime', 'Affiliation': 'Unità Di Mobilizzazione e Raccolta CSE, Divisione Di Laboratorio Di Ematoncologia Clinica, Istituto Europeo Di Oncologia IRCCS- Milano, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Menna', 'Affiliation': 'Data Management - Istituto Europeo Di Oncologia IRCCS - Milano, Italy.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Lionetti', 'Affiliation': 'Data Management - Istituto Europeo Di Oncologia IRCCS - Milano, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bertolini', 'Affiliation': 'Unità Di Mobilizzazione e Raccolta CSE, Divisione Di Laboratorio Di Ematoncologia Clinica, Istituto Europeo Di Oncologia IRCCS- Milano, Italy.'}]",Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis,['10.1016/j.transci.2020.102819']
2875,32443357,"A prospective observational study to explore the correlation of peripheral arterial pulse/resistance index, organ function, and inflammation in patients with septic shock.","INTRODUCTION
The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect. We aimed to design an observational study protocol to explore the correlation of peripheral arterial pulse/resistance index, organ function and inflammation in patients with septic shock.
METHODS AND ANALYSIS
A total of 60 patients with septic shock in the Affiliated Hospital of Southwest Medical University from June 2020 to September 2020 and 20 healthy volunteers will be enrolled. Total of 60 patients with septic shock will be randomly divided into 20 groups by lot method. Group 1: fluid resuscitation; Group 2: fluid resuscitation + norepinephrine; Group 3: fluid resuscitation + norepinephrine + ulinastatin; Group 4: healthy control group. Fluid resuscitation is an early goal-directed fluid resuscitation in which norepinephrine is adjusted by a senior intensive care unit specialist for clinical presentation and ulinastatin is pumped at 20,000 U/h. Index including vascular ultrasound, inflammatory factors, organ function will be collected and analyzed.
DISCUSSION
Existing studies on septic shock focus on hemodynamics of the heart, brain, and kidney, while the differences in blood flow between peripheral blood vessels and protective renal vessels may be consistent, and imaging analysis is still lacking. This study protocol aims to explore the correlation of peripheral arterial pulsation index/resistance index, organ function, and inflammation in patients with septic shock.
TRIAL REGISTRATION
Chinese Clinical trial registry: ChiCTR2000031565.",2020,"The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect.","['patients with septic shock', '60 patients with septic shock', '60 patients with septic shock in the Affiliated Hospital of Southwest Medical University from June 2020 to September 2020 and 20 healthy volunteers will be enrolled']","['Fluid resuscitation', 'fluid resuscitation; Group 2: fluid resuscitation\u200a+\u200anorepinephrine; Group 3: fluid resuscitation\u200a+\u200anorepinephrine\u200a+\u200aulinastatin; Group 4: healthy control group']","['peripheral arterial pulse/resistance index, organ function and inflammation', 'peripheral arterial pulse/resistance index, organ function, and inflammation', 'peripheral arterial pulsation index/resistance index, organ function, and inflammation', 'Index including vascular ultrasound, inflammatory factors, organ function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0948543', 'cui_str': 'Vascular ultrasound'}]",60.0,0.138439,"The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect.","[{'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'ICU, Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Leng', 'Affiliation': 'Department of General Surgery, Affiliated Hospital of Traditional Chinese Medicine, Southwest Medical University.'}, {'ForeName': 'Changxue', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'ICU, Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Critical Care, Luzhou Maternal and Child Health Hospital, Luzhou, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000020235']
2876,32443364,Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation after anterior cruciate ligament reconstruction: A study protocol for a randomized controlled trial.,"INTRODUCTION
Rehabilitation after anterior cruciate ligament (ACL) reconstruction is critical to patient outcome. Despite its importance; however, hospital-based rehabilitation is limited, with barriers, including distance and cost. With recent technological advancements, wearable devices have actively been used to address these barriers. In this study, we propose a randomized controlled trial protocol investigating the efficacy and feasibility of home-based rehabilitation after ACL reconstruction using a smart wearable device providing electrical stimulation that allows knee exercise.
METHODS AND ANALYSIS
This is a protocol proposal for a prospective, single-center, randomized, controlled study. We plan to recruit adults discharged after ACL reconstruction; the recruited subjects will be randomly allocated to 1 of 2 groups, using a computer-generated randomization method: the intervention (n = 20) or control group (n = 20). The intervention group will receive a 6-week home-based rehabilitation program using smart wearable device. The control group will undergo a 6-week self-exercise program as normal. The following outcomes will be assessed at baseline, 2 weeks, and 6 weeks post the 6-week intervention program: quadriceps strength of the affect side as measured by a dynamometer (primary outcome); range of motion; root mean square of quadriceps muscle using surface electromyography; knee function using questionnaire; quality of life; subject's satisfaction score using questionnaire; frequency and duration of exercise; and knee pain. An intention-to-treat analysis will be conducted for the primary outcome.
DISCUSSION
This study is a prospective, single-center, randomized, controlled study. This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device. The findings of this study will help to establish a home-based rehabilitation program to better recovery in patients with ACL reconstruction.
TRIAL REGISTRATION NUMBER
This protocol was registered in ClinicalTrials.gov, under the number NCT04079205.",2020,"This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device.","['patients after ACL reconstruction using a smart wearable device', 'adults discharged after ACL reconstruction; the recruited subjects', 'anterior cruciate ligament reconstruction', 'patients with ACL reconstruction']","['home-based rehabilitation after ACL reconstruction', '6-week self-exercise program', '6-week home-based rehabilitation program using smart wearable device', 'Rehabilitation after anterior cruciate ligament (ACL) reconstruction', 'Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation', 'structured home-based rehabilitation program']","[""quadriceps strength of the affect side as measured by a dynamometer (primary outcome); range of motion; root mean square of quadriceps muscle using surface electromyography; knee function using questionnaire; quality of life; subject's satisfaction score using questionnaire; frequency and duration of exercise; and knee pain""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0454364', 'cui_str': 'Knee exercises'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]",,0.103089,"This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device.","[{'ForeName': 'Gowun', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}, {'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}, {'ForeName': 'Tae Woo', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul.'}, {'ForeName': 'Yong Seuk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'EXOSYSTEMS Inc., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}]",Medicine,['10.1097/MD.0000000000020256']
2877,32493662,Continuous Magnesium Infusion to Prevent Atrial Fibrillation After Cardiac Surgery: A Sequential Matched Case-Controlled Pilot Study.,"OBJECTIVE
The authors aimed to test whether a bolus of magnesium followed by continuous intravenous infusion might prevent the development of atrial fibrillation (AF) after cardiac surgery.
DESIGN
Sequential, matched, case-controlled pilot study.
SETTING
Tertiary university hospital.
PARTICIPANTS
Matched cohort of 99 patients before and intervention cohort of 99 consecutive patients after the introduction of a continuous magnesium infusion protocol.
INTERVENTIONS
The magnesium infusion protocol consisted of a 10 mmol loading dose of magnesium sulphate followed by a continuous infusion of 3 mmol/h over a maximum duration of 96 hours or until intensive care unit discharge.
MEASUREMENTS AND MAIN RESULTS
The study groups were balanced except for a lower cardiac index in the intervention cohort. The mean duration of magnesium infusion was 27.93 hours (95% confidence interval [CI]: 24.10-31.76 hours). The intervention group had greater serum peak magnesium levels: 1.72 mmol/L ± 0.34 on day 1, 1.32 ± 0.36 on day 2 versus 1.01 ± 1.14 and 0.97 ± 0.13, respectively, in the control group (p < 0.01). Atrial fibrillation occurred in 25 patients (25.3%) in the intervention group and 40 patients (40.4%) in the control group (odds ratio 0.49, 95% CI, 0.27-0.92; p = 0.023). On a multivariate Cox proportional hazards model, the hazard ratio for the development of AF was significantly less in the intervention group (hazard ratio 0.45, 95% CI, 0.26-0.77; p = 0.004).
CONCLUSION
The magnesium delivery strategy was associated with a decreased incidence of postoperative AF in cardiac surgery patients. These findings provide a rationale and preliminary data for the design of future randomized controlled trials.",2020,"The intervention group had greater serum peak magnesium levels: 1.72 mmol/L ± 0.34 on day 1, 1.32 ± 0.36 on day 2 versus 1.01 ± 1.14 and 0.97 ± 0.13, respectively, in the control group (p < 0.01).","['cardiac surgery patients', 'Tertiary university hospital', 'Matched cohort of 99 patients before and intervention cohort of 99 consecutive patients after the introduction of a continuous magnesium infusion protocol']","['magnesium sulphate', 'Continuous Magnesium Infusion', 'magnesium']","['Atrial Fibrillation', 'hazard ratio for the development of AF', 'serum peak magnesium levels', 'Atrial fibrillation', 'atrial fibrillation (AF', 'mean duration of magnesium infusion']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",99.0,0.324668,"The intervention group had greater serum peak magnesium levels: 1.72 mmol/L ± 0.34 on day 1, 1.32 ± 0.36 on day 2 versus 1.01 ± 1.14 and 0.97 ± 0.13, respectively, in the control group (p < 0.01).","[{'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Osawa', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Salvatore L', 'Initials': 'SL', 'LastName': 'Cutuli', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Fondazione Policlinico Universitario A. Gemelli, Universita Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Peck', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Hessels', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Department of Critical Care, University of Groningen, University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Australian and New Zealand Intensive Care Research Centre, Monash University, School of Public Health and Preventive Medicine, Melbourne, Australia.'}, {'ForeName': 'Julia T', 'Initials': 'JT', 'LastName': 'Fukushima', 'Affiliation': 'Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Siven', 'Initials': 'S', 'LastName': 'Seevanayagam', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Heidelberg, Melbourne, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Matalanis', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Heidelberg, Melbourne, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Centre for Integrated Critical Care, School of Medicine, The University of Melbourne, Melbourne, Australia. Electronic address: rinaldo.Bellomo@austin.org.au.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.04.006']
2878,32493693,"Phase 3, Randomized, Double-Blind, Active-Comparator (Darbepoetin Alfa) Study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan.","BACKGROUND
Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in China for dialysis-dependent CKD anemia.
METHODS
This phase 3, 24-week, double-blind, double-dummy study evaluated roxadustat's noninferiority to darbepoetin alfa for hemodialysis-dependent CKD anemia. We randomly assigned Japanese patients to oral roxadustat three times weekly or to darbepoetin alfa injections once weekly, titrating doses to maintain hemoglobin between 10-12 g/dl. The primary end point was change of average hemoglobin from baseline to weeks 18-24 ( ∆ Hb 18-24 ). Secondary end points were average hemoglobin and proportion of patients with hemoglobin between 10-12 g/dl (maintenance rate) at weeks 18-24, and iron parameters. Safety assessments included treatment-emergent adverse events and adjudicated ophthalmologic findings.
RESULTS
We randomly assigned 303 patients to roxadustat ( n =151) or darbepoetin alfa ( n =152). The difference between roxadustat and darbepoetin alfa in ∆ Hb 18-24 was -0.02 g/dl (95% confidence interval, -0.18 to 0.15), confirming roxadustat's noninferiority to darbepoetin alfa. Average hemoglobin at weeks 18-24 with roxadustat was 10.99 g/dl (95% confidence interval: 10.88 to 11.10), confirming its efficacy. Among patients with one or more hemoglobin value during weeks 18-24, the maintenance rate was 95.2% with roxadustat and 91.3% with darbepoetin alfa. Serum iron, ferritin, and transferrin saturation remained clinically stable with roxadustat; transferrin and total iron binding capacity increased through week 4 before stabilizing. Common treatment-emergent adverse events were nasopharyngitis, shunt stenosis, diarrhea, contusion, and vomiting. The proportion of patients with new or worsening retinal hemorrhage was 32.4% with roxadustat and 36.6% with darbepoetin alfa. We observed no clinically meaningful changes in retinal thickness groups.
CONCLUSIONS
Roxadustat maintained hemoglobin within 10-12 g/dl in patients on hemodialysis and was noninferior to darbepoetin alfa. Treatment-emergent adverse events were consistent with previous reports.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER
A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients with Anemia, NCT02952092 (ClinicalTrials.gov).",2020,"Serum iron, ferritin, and transferrin saturation remained clinically stable with roxadustat; transferrin and total iron binding capacity increased through week 4 before stabilizing.","['hemodialysis-dependent CKD anemia', 'Hemodialysis Chronic Kidney Disease Patients with Anemia, NCT02952092 (ClinicalTrials.gov', 'CKD Patients with Anemia on Hemodialysis in Japan', '∆', '303 patients to roxadustat ( n =151) or']","['ASP1517', 'darbepoetin alfa', 'darbepoetin alfa injections']","['proportion of patients with new or worsening retinal hemorrhage', 'Serum iron, ferritin, and transferrin saturation', 'Safety assessments included treatment-emergent adverse events and adjudicated ophthalmologic findings', 'Average hemoglobin', 'hemoglobin value', 'change of average hemoglobin', 'total iron binding capacity', 'nasopharyngitis, shunt stenosis, diarrhea, contusion, and vomiting', 'maintenance rate', 'average hemoglobin and proportion of patients with hemoglobin']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C4027177', 'cui_str': 'darbepoetin alfa Injection'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0035317', 'cui_str': 'Retinal hemorrhage'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0700379', 'cui_str': 'Total iron binding capacity'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C1142174', 'cui_str': 'Shunt stenosis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",303.0,0.137155,"Serum iron, ferritin, and transferrin saturation remained clinically stable with roxadustat; transferrin and total iron binding capacity increased through week 4 before stabilizing.","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Department of Nephrology, Showa University School of Medicine, Tokyo, Japan akizawa@med.showa-u.ac.jp.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Data Science, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yamaguchi', 'Affiliation': 'Japan-Asia Data Science, Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Yoshikatsu', 'Initials': 'Y', 'LastName': 'Majikawa', 'Affiliation': 'Japan-Asia Clinical Development 2, Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reusch', 'Affiliation': 'Development Medical Science Urology and Nephrology, Astellas Pharma Europe B.V., Leiden, The Netherlands.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019060623']
2879,32493715,"Starch Digestion-Related Amylase Genetic Variants, Diet, and Changes in Adiposity: Analyses in Prospective Cohort Studies and a Randomized Dietary Intervention.","Salivary amylase, encoded by the AMY1 gene, is responsible for the digestion of carbohydrates. We investigated associations of the AMY1 genetic variations with general and central adiposity changes considering dietary carbohydrate intake among 32054 adults from 4 prospective cohort studies. A genetic risk score (GRS) was calculated based on nine AMY1 single-nucleotide polymorphisms, with higher AMY1-GRS indicating higher activity of salivary amylase. We meta-analyzed interactions between AMY1-GRS and dietary intake for changes in general and central adiposity over 5.5-10 years. We found that carbohydrate food intake significantly altered associations of AMY1 -GRS with changes in body mass index ( P interaction =0.001) and waist circumference ( P interaction <0.001). Results were consistent and significant in female cohorts rather than in male cohorts. Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low. Also, in a 2-year randomized dietary intervention trial, associations of AMY1 -GRS with changes in weight ( P interaction =0.023) and waist circumference ( P interaction = 0.037) were significantly modified by carbohydrate intake. Our results suggest the importance of precision nutrition strategies considering participants' genetic adaptation to carbohydrate-rich diets in regulating general and central adiposity.",2020,"Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low.",['32054 adults from 4 prospective cohort studies'],[],"['genetic risk score (GRS', 'waist circumference', 'adiposity if dietary carbohydrate food intake', 'body mass index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012170', 'cui_str': 'Carbohydrates, Dietary'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",32054.0,0.0265795,"Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low.","[{'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA nhyoh@channing.harvard.edu lqi1@tulane.edu.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA nhyoh@channing.harvard.edu lqi1@tulane.edu.'}]",Diabetes,['10.2337/db19-1257']
2880,32493720,Induction of Neutralizing Responses against Autologous Virus in Maternal HIV Vaccine Trials.,"A maternal vaccine capable of boosting neutralizing antibody (NAb) responses directed against circulating viruses in HIV-infected pregnant women could effectively decrease mother-to-child transmission of HIV. However, it is not known if an HIV envelope (Env) vaccine administered to infected pregnant women could enhance autologous virus neutralization and thereby reduce this risk of vertical HIV transmission. Here, we assessed autologous virus NAb responses in maternal plasma samples obtained from AIDS Vaccine Evaluation Group (AVEG) protocols 104 and 102, representing historical phase I safety and immunogenicity trials of recombinant HIV Env subunit vaccines administered to HIV-infected pregnant women (ClinicalTrials registration no. NCT00001041). Maternal HIV Env-specific plasma binding and neutralizing antibody responses were characterized before and after vaccination in 15 AVEG 104 ( n = 10 vaccine recipients, n = 5 placebo recipients) and 2 AVEG 102 ( n = 1 vaccine recipient, n = 1 placebo recipient) participants. Single-genome amplification (SGA) was used to obtain HIV env gene sequences of autologous maternal viruses for pseudovirus production and neutralization sensitivity testing in pre- and postvaccination plasma of HIV-infected pregnant vaccine recipients ( n = 6 gp120, n = 1 gp160) and placebo recipients ( n = 3). We detected an increase in Env subunit MN gp120-specific IgG binding in the group of vaccine recipients between the first immunization visit and the last visit at delivery ( P = 0.027, 2-sided Wilcoxon test). While no difference was observed in the levels of autologous virus neutralization potency between groups, in both groups maternal plasma collected at delivery more effectively neutralized autologous viruses from early pregnancy than late pregnancy. Immunization strategies capable of further enhancing these autologous virus NAb responses in pregnant women will be important to block vertical transmission of HIV. IMPORTANCE Maternal antiretroviral therapy (ART) has effectively reduced but not eliminated the burden of mother-to-child transmission of HIV across the globe, as an estimated 160,000 children were newly infected with HIV in 2018. Thus, additional preventive strategies beyond ART will be required to close the remaining gap and end the pediatric HIV epidemic. A maternal active immunization strategy that synergizes with maternal ART could further reduce infant HIV infections. In this study, we found that two historic HIV Env vaccines did not enhance the ability of HIV-infected pregnant women to neutralize autologous viruses. Therefore, next-generation maternal HIV vaccine candidates must employ alternate approaches to achieve potent neutralizing antibody and perhaps nonneutralizing antibody responses to effectively impede vertical virus transmission. Moreover, these approaches must reflect the broad diversity of HIV strains and widespread availability of ART worldwide.",2020,"While no difference was observed in the levels of autologous virus neutralization potency between groups, in both groups maternal plasma collected at delivery more effectively neutralized autologous viruses from early pregnancy than late pregnancy.","['160,000 children were newly infected with HIV in 2018', 'HIV-infected pregnant women', 'HIV-infected pregnant women (ClinicalTrials registration no', 'pregnant women']","['Maternal antiretroviral therapy (ART', 'Single-genome amplification (SGA', 'recombinant HIV Env subunit vaccines', 'AVEG 102 ( n \u2009=\u20091 vaccine recipient, n \u2009=\u20091 placebo', 'placebo']","['Env subunit MN gp120-specific IgG binding', 'levels of autologous virus neutralization potency', 'Maternal HIV Env-specific plasma binding and neutralizing antibody responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0085432', 'cui_str': 'AIDS Vaccines'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]",160000.0,0.230413,"While no difference was observed in the levels of autologous virus neutralization potency between groups, in both groups maternal plasma collected at delivery more effectively neutralized autologous viruses from early pregnancy than late pregnancy.","[{'ForeName': 'Eliza D', 'Initials': 'ED', 'LastName': 'Hompe', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Jesse F', 'Initials': 'JF', 'LastName': 'Mangold', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Eudailey', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McGuire', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Barton F', 'Initials': 'BF', 'LastName': 'Haynes', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'M Anthony', 'Initials': 'MA', 'LastName': 'Moody', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Wright', 'Affiliation': 'Department of Pediatrics, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Genevieve G', 'Initials': 'GG', 'LastName': 'Fouda', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Elena E', 'Initials': 'EE', 'LastName': 'Giorgi', 'Affiliation': 'Los Alamos National Laboratory, Los Alamos, New Mexico, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Sallie R', 'Initials': 'SR', 'LastName': 'Permar', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA sallie.permar@duke.edu.'}]",mSphere,['10.1128/mSphere.00254-20']
2881,32494769,Comparison of ovulation induction with letrozole plus dexamethasone and letrozole alone in infertile women with polycystic ovarian disease: An RCT.,"Background
Infertility is characterized by the inability to obtain a successful pregnancy after 6 months or more with unprotected and regular intercourse. In developing countries, the incidence of infertility is 2%. The causes of infertility could be male factor or female factor, or mixed factor.
Objective
This study was conducted with the aim of comparison the ovarian response to letrozole alone and letrozole plus dexamethasone in infertile women with poly cystic ovarian disease (PCOS).
Materials and Methods
This randomized clinical trial was conducted on 120 infertile women with PCOS referred to Ali-Ebne-Abitaleb hospital, Zahedan, Iran from February to August 2017 into two groups: group I received letrozole alone and group II recived letrozole plus dexamethasone. The endometrial thickness, follicle diameter, and ovulation were evaluated and compared by ultrasound on days 12 to 14.
Results
The mean thickness of endometrium was not different between two groups. Pregnancy rate was 8% in letrozole group and 23% in Letrozole plus Dexamethasone (p = 0.024). Also, the mean diameter of follicles in two groups were not statistically significant.
Conclusion
Overall, this study showed that dexamethasone may increase pregnancy rate.",2020,Pregnancy rate was 8% in letrozole group and 23% in Letrozole plus Dexamethasone (p = 0.024).,"['infertile women with polycystic ovarian disease', 'infertile women with poly cystic ovarian disease (PCOS', '120 infertile women with PCOS referred to Ali-Ebne-Abitaleb hospital, Zahedan, Iran from February to August 2017 into two groups: group I received']","['dexamethasone', 'Letrozole plus Dexamethasone', 'letrozole alone and letrozole plus dexamethasone', 'letrozole', 'letrozole alone and group II recived letrozole plus dexamethasone', 'letrozole plus dexamethasone and letrozole alone']","['Pregnancy rate', 'mean diameter of follicles', 'pregnancy rate', 'endometrial thickness, follicle diameter, and ovulation', 'mean thickness of endometrium']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0029928', 'cui_str': 'Disorder of ovary'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441843', 'cui_str': 'Group I'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}]",120.0,0.149039,Pregnancy rate was 8% in letrozole group and 23% in Letrozole plus Dexamethasone (p = 0.024).,"[{'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Farzaneh', 'Affiliation': 'Infectious Disease and Tropical Medicine Research Center, Zahedan University of Medical Science, Zahedan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Afshar', 'Affiliation': 'Zahedan University of Medical Science, Zahedan, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i4.6893']
2882,32494772,"Randomized trial to evaluate contraceptive efficacy, safety and acceptability of a two-rod contraceptive implant over 4 years in the Dominican Republic.","Objective
Sino-implant (II) is a contraceptive implant that had a commodity price one-third of the competing products a decade ago. To make Sino-implant (II) more widely available, we conducted a trial to collect safety and efficacy data required for World Health Organization (WHO) prequalification, a quality standard allowing global donors to procure a pharmaceutical product.
Study design
This was a randomized controlled trial allocating 650 participants to either Sino-implant (II) or Jadelle®. Participants were seen at 1 and 6 months, and then semiannually. The primary efficacy measure was the pregnancy Pearl Index [number of pregnancies per 100 women-years (WY) of follow-up] in the Sino-implant (II) group during up to 4 years of implant use.
Results
For the primary outcome, Sino-implant (II) had a 4-year Pearl Index of 0.74 (95% confidence interval, 0.36-1.37) compared to 0.00 (95% confidence interval, 0.00-1.04) for Jadelle®. The Sino-implant (II) pregnancy rate was significantly higher in the fourth year (3.54 per 100 WY) than in the first 3 years combined (0.18 per 100 WY; p <.001). Total levonorgestrel concentrations were equivalent between groups at month 12, but were 19%, 22% and 32% lower in the Sino-implant (II) group at months 24, 36 and 48, respectively (p <.001 at each time point). Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001).
Conclusion
Based on these results, WHO prequalified Sino-Implant (II) with a 3-year use label in June 2017, 2 years shorter than the 5-year duration of Jadelle®.
Implications
WHO prequalification allows global donors to procure Sino-implant (II), which means women in many low resource countries will have greater access to highly effective and acceptable contraceptive implants. Our study noted important clinical differences, including shorter duration of high effectiveness with Sino-implant (II) when compared to the other available two-rod system, Jadelle®. Introduction strategies should include appropriate training on these differences.",2019,"Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001).
",['650 participants to either Sino-implant (II) or Jadelle®'],"['Objective\n\n\nSino-implant (II', 'two-rod contraceptive implant']","['Sino-implant (II) had a 4-year Pearl Index', 'Sino-implant (II) pregnancy rate', 'Total levonorgestrel concentrations', 'contraceptive efficacy, safety and acceptability', 'breakage rates', 'Safety and acceptability', 'pregnancy Pearl Index']","[{'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C1657106', 'cui_str': 'Contraceptive implant'}]","[{'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",650.0,0.108083,"Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001).
","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Steiner', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Brache', 'Affiliation': 'Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA), Santo Domingo, Dominican Republic.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Callahan', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Halpern', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jorge', 'Affiliation': 'Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA), Santo Domingo, Dominican Republic.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wevill', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sergison', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dorflinger', 'Affiliation': 'Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.'}]",Contraception: X,['10.1016/j.conx.2019.100006']
2883,32494942,Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American Young Adults (EMERGE): A Feasibility Randomized Clinical Trial.,"Economic vulnerability, such as homelessness and unemployment, contributes to HIV risk among U.S. racial minorities. Yet, few economic-strengthening interventions have been adapted for HIV prevention in this population. This study assessed the feasibility of conducting a randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors. The experimental group received text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages. The comparison group received text messages on job openings only. Primary feasibility objectives assessed recruitment, randomization, participation, and retention. Secondary objectives examined employment, sexual risk behaviors, and HIV preventive behaviors. Outcome assessments used an in-person pre- and post-intervention interview and a weekly text message survey. Several progression criteria for a definitive trial were met. Thirty-eight participants were randomized to experimental (n = 19) or comparison group (n = 19) of which 95% were retained. The comparison intervention enhanced willingness to be randomized and reduced non-participation. Mean age of participants was 21.0 years; 35% were male; 81% were unemployed. Fifty-eight percent (58%) of experimental participants completed ≥ 70% of intervention activities, and 74% completed ≥ 50% of intervention activities. Participation in intervention activities and outcome assessments was highest in the first half (~ 10 weeks) of the study. Seventy-one percent (71%) of weekly text message surveys received a response through week 14, but responsiveness declined to 37% of participants responding to ≥ 70% of weekly text message surveys at the end of the study. The experimental group reported higher employment (from 32% at baseline to 83% at week 26) and lower unprotected sex (79% to 58%) over time compared to reported changes in employment (37% to 47%) and unprotected sex (63% to 53%) over time in the comparison group. Conducting this feasibility trial was a critical step in the process of designing and testing a behavioral intervention. Development of a fully-powered effectiveness trial should take into account lessons learned regarding intervention duration, screening, and measurement.Trial Registration ClinicalTrials.gov. NCT03766165. Registered 04 December 2018. https://clinicaltrials.gov/ct2/show/NCT03766165.",2020,The experimental group reported higher employment (from 32% at baseline to 83% at week 26) and lower unprotected sex (79% to 58%) over time compared to reported changes in employment (37% to 47%) and unprotected sex (63% to 53%) over time in the comparison group.,"['Mean age of participants was 21.0\xa0years; 35% were male; 81% were unemployed', 'economically-vulnerable African-American young adults', 'Economically-Vulnerable African-American Young Adults (EMERGE', 'Thirty-eight participants']","['text messages on job openings only', 'Microenterprise Intervention', 'text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages', 'microenterprise intervention']","['higher employment', 'Sexual Risk Behaviors', 'employment, sexual risk behaviors, and HIV preventive behaviors', 'recruitment, randomization, participation, and retention', 'sexual risk behaviors', 'person pre- and post-intervention interview and a weekly text message survey']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",38.0,0.0844624,The experimental group reported higher employment (from 32% at baseline to 83% at week 26) and lower unprotected sex (79% to 58%) over time compared to reported changes in employment (37% to 47%) and unprotected sex (63% to 53%) over time in the comparison group.,"[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Jennings Mayo-Wilson', 'Affiliation': 'Indiana University School of Public Health, Department of Applied Health Science, 1025 E. 7th Street, Bloomington, IN, USA. ljmayowi@iu.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Fatmata', 'Initials': 'F', 'LastName': 'Timbo', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'The Brown School, Washington University in St. Louis, Goldfarb, One Brookings, Drive, St. Louis, MO, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, USA.'}, {'ForeName': 'Grace T', 'Initials': 'GT', 'LastName': 'Yi', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Bee-Ah', 'Initials': 'BA', 'LastName': 'Kang', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences, 5510 Nathan Shock Drive, Baltimore, MD, USA.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of Biostatistics, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Dodge', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins University School of Nursing, 525 N. Wolfe Street, Baltimore, MD, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02931-0']
2884,32498637,Influence of an Exergaming Training Program on Reducing the Expression of IL-10 and TGF-β in Cancer Patients.,"Objective: To evaluate the effect of exergaming in the plasma levels of adipokines (interleukin [IL]-1β, IL-6, IL-8, and tumor necrosis factor-alpha [TNF-α]), Th1 (IL-2, IL-12, and interferon gamma [IFN-γ]), Th2 (IL-4 and IL-33), Th17 (IL-17 and IL-23), and regulatory T (Treg) (IL-10 and transforming growth factor-beta [TGF-β]) in cancer patients undergoing treatment. Materials and Methods: We conducted a quasi-experimental control clinical trial using exergaming in all groups through the Xbox 360 Kinect™. The game used in this study was called Your Shape Fitness Evolved 2012 . The volunteer participants played the game two to three times per week, for a total of 20 sessions. Forty-five volunteer participants were divided into 3 groups: cancer patients undergoing chemotherapy and/or radiotherapy treatment (chemotherapy and/or radiotherapy group CRG; n = 15); cancer patients who finished chemotherapy and/or radiotherapy treatment (cancer accompaniment group CAG; n = 15); and the control group (volunteers without a cancer diagnosis CG; n = 15). In the pre- and post-training period, all volunteers submitted to blood collection procedures using the enzyme-linked immunosorbent assay (ELISA). This test was used to obtain the levels of adipokines expression (IL-1β, IL-6, IL-8, and TNF-α) and the cytokine profiles Th1 (IL-2, IL-12, and IFN-γ), Th2 (IL-4 and IL-33), Th17 (IL-17 and IL-23), and Treg (IL-10 and TGF-β). Results: After exergaming, the CRG showed significant reductions in proinflammatory cytokines (IL-6: P < 0.05; IL-10: P = 0.038; TGF-β: P = 0.049) and for CAG (IL-10: P = 0.034), as well as a reduction in the expression of cytokines related to the action of T lymphocytes. Conclusion: Exergaming promoted changes in the expression of cytokine profiles IL-6, IL-10, and TGF-β, which correlated with the action profiles of CD4 + T lymphocytes.",2020,"Exergaming promoted changes in the expression of cytokine profiles IL-6, IL-10, and TGF-β, which correlated with the action profiles of CD4 + T lymphocytes.","['Cancer Patients', 'Forty-five volunteer participants were divided into 3 groups: cancer patients undergoing', 'all groups through the Xbox 360 Kinect™', 'cancer patients undergoing treatment']","['chemotherapy and/or radiotherapy treatment (chemotherapy and/or radiotherapy group CRG; n \u2009=\u200915); cancer patients who finished chemotherapy and/or radiotherapy treatment (cancer accompaniment group CAG; n \u2009=\u200915); and the control group (volunteers without a cancer diagnosis CG', 'Exergaming Training Program', 'IL-10 and transforming growth factor-beta [TGF-β']","['expression of cytokine profiles IL-6, IL-10, and TGF-β', 'levels of adipokines expression (IL-1β, IL-6, IL-8, and TNF-α) and the cytokine profiles Th1 (IL-2, IL-12, and IFN-γ), Th2 (IL-4 and IL-33), Th17 (IL-17 and IL-23), and Treg (IL-10 and TGF-β', 'plasma levels of adipokines (interleukin [IL]-1β, IL-6, IL-8, and tumor necrosis factor-alpha [TNF-α]), Th1 (IL-2, IL-12, and interferon gamma [IFN-γ', 'IL-4 and IL-33), Th17 (IL-17 and IL-23), and regulatory T (Treg', 'proinflammatory cytokines', 'Expression of IL-10 and TGF-β']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0040690', 'cui_str': 'Platelet Transforming Growth Factor'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C1667752', 'cui_str': 'IL33 protein, human'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",45.0,0.0339559,"Exergaming promoted changes in the expression of cytokine profiles IL-6, IL-10, and TGF-β, which correlated with the action profiles of CD4 + T lymphocytes.","[{'ForeName': 'Ricardo da Silva', 'Initials': 'RDS', 'LastName': 'Alves', 'Affiliation': 'Bioscience Program, Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Douglas Reis', 'Initials': 'DR', 'LastName': 'Abdalla', 'Affiliation': 'Health Sciences, Humans Talents Faculty and University of Uberaba, Uberaba, Brazil.'}, {'ForeName': 'Denise Hollanda', 'Initials': 'DH', 'LastName': 'Iunes', 'Affiliation': 'Motricity Science Institute, and Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Karina Oliveira Prado', 'Initials': 'KOP', 'LastName': 'Mariano', 'Affiliation': 'Rehabilitation Science Program, Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Juliana Bassalobre Carvalho', 'Initials': 'JBC', 'LastName': 'Borges', 'Affiliation': 'Motricity Science Institute, and Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Eddie Fernando Cândido', 'Initials': 'EFC', 'LastName': 'Murta', 'Affiliation': 'Institute of Oncology Research, Federal University of Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Márcia Antoniazi', 'Initials': 'MA', 'LastName': 'Michelin', 'Affiliation': 'Institute of Oncology Research, Federal University of Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Leonardo César', 'Initials': 'LC', 'LastName': 'Carvalho', 'Affiliation': 'Bioscience Program, Federal University of Alfenas, Alfenas, Brazil.'}]",Games for health journal,['10.1089/g4h.2020.0022']
2885,32498699,"The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) protocol.","INTRODUCTION
Renal stones are common, with a lifetime prevalence of 10% in adults. Global incidence is increasing due to increases in obesity and diabetes, with these patient populations being more likely to suffer renal stone disease. Flank pain from stones (renal colic) is the most common cause of emergency admission to UK urology departments. Stones most commonly develop in the lower pole of the kidney (in ~35% of cases) and here are least likely to pass without intervention. Currently there are three technologies available within the UK National Health Service to remove lower pole kidney stones: extracorporeal shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and flexible ureterorenoscopy (FURS) with laser lithotripsy. Current evidence indicates there is uncertainty regarding the management of lower pole stones, and each treatment has advantages and disadvantages. The aim of this trial is to determine the clinical and cost effectiveness of FURS compared with ESWL or PCNL in the treatment of lower pole kidney stones.
METHODS
The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones. Patients aged ≥16 years with a stone(s) in the lower pole of either kidney confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) and requiring treatment for a stone ≤10 mm will be randomised to receive FURS or ESWL (RCT1), and those requiring treatment for a stone >10 mm to ≤25 mm will be randomised to receive FURS or PCNL (RCT2). Participants will undergo follow-up by questionnaires every week up to 12 weeks post-intervention and at 12 months post-randomisation. The primary clinical outcome is health status measured by the area under the curve calculated from multiple measurements of the EuroQol five dimensions five-level version (EQ-5D-5L) questionnaire up to 12 weeks post-intervention. The primary economic outcome is the incremental cost per quality-adjusted life year gained at 12 months post-randomisation.
DISCUSSION
The PUrE trial aims to provide robust evidence on health status, quality of life, clinical outcomes and resource use to directly inform choice and National Health Service provision of the three treatment options.
TRIAL REGISTRATION
ISRCTN: ISRCTN98970319. Registered on 11 November 2015.",2020,"The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones.","['Flank pain from stones (renal colic', 'lower pole kidney stones', 'Patients aged ≥16\u2009years with a stone(s) in the lower pole of either kidney confirmed by non-contrast computed tomography of the kidney, ureter and bladder\xa0(CTKUB) and requiring treatment for a stone ≤10\u2009mm', 'stones in the lower pole of the kidney']","['percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy', 'ESWL or PCNL', 'FURS or PCNL (RCT2', 'PUrE (PCNL, FURS and ESWL', 'FURS', 'FURS or ESWL (RCT1', 'shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and flexible ureterorenoscopy (FURS) with laser lithotripsy', 'surgical interventions', 'FURS versus ESWL or PCNL']","['health status measured by the area under the curve calculated from multiple measurements of the EuroQol five dimensions five-level version (EQ-5D-5L) questionnaire', 'incremental cost per quality-adjusted life year gained at 12\u2009months post-randomisation']","[{'cui': 'C0016199', 'cui_str': 'Flank pain'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.185133,"The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones.","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'McClinton', 'Affiliation': 'Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK. pure@abdn.ac.uk.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Starr', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lam', 'Affiliation': 'Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Hernandez', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pickard', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Anson', 'Affiliation': ""St George's Hospital, London, UK.""}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Clark', 'Affiliation': 'Stone Patient Advisory Group, Section of Endourology, British Association of Urological Surgeons, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'MacLennan', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Daron', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Turney', 'Affiliation': 'Oxford University Hospitals NHS Trust, Headley Way, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Wiseman', 'Affiliation': ""Addenbrooke's NHS Trust, Hills Road, Cambridge, UK.""}]",Trials,['10.1186/s13063-020-04326-x']
2886,32498755,EFFECTS OF SLOW VERSUS FAST-DIGESTED PROTEIN SUPPLEMENTATION COMBINED WITH MIXED POWER TRAINING ON MUSCLE FUNCTION AND FUNCTIONAL CAPACITIES IN OLDER MEN.,"Aging leads to a progressive loss of muscle function (MF) and quality (MQ: muscle strength [MS]/lean muscle mass [LM]). Power training and protein (PROT) supplementation have been proposed as efficient interventions to improve MF and MQ. Discrepancies between results appear to be mainly related to the type and/or dose of proteins used. The present study aimed at determining whether or not mixed power training (MPT) combined with fast-digested PROT (F-PROT) leads to greater improvements in MF and MQ in elderly men than MPT combined with slow-digested PROT (S-PROT) or MPT alone. Sixty elderly men (Age:69±7years; BMI:18-30kg.m-2) randomized into 3 groups: 1) Placebo+MPT (PLA; n=19); 2) F-PROT+MPT (n=21); 3) S-PROT+MPT (n=20) completed the intervention. LM, handgrip and knee extensor MS and MQ, functional capacity, serum metabolic markers, skeletal muscle characteristics, dietary intake and total energy expenditure were measured. The interventions consisted in 12 weeks of MPT (3-times/week;1h/session) combined with a supplement (30g: 10g per meal) of F-PROT (whey) or S-PROT (casein) or a Placebo. No difference was observed among groups for age, BMI, number of steps and dietary intake pre- and post-intervention. All groups improved significantly their LM, and lower limb MS/MQ, functional capacity, muscle characteristics and serum parameters following the MPT. Importantly, no difference between groups was observed following the MPT. Altogether, adding 30 g PROT per day to MPT, regardless of the type, does not provide additional benefits to MPT alone in older men ingesting an adequate (i.e. above recommended daily allowance) amount of protein per day.",2020,"No difference was observed among groups for age, BMI, number of steps and dietary intake pre- and post-intervention.","['Sixty elderly men (Age:69±7years; BMI:18-30kg.m-2', 'elderly men than MPT combined with slow-digested PROT (S-PROT) or MPT alone']","['MPT (3-times/week;1h/session) combined with a supplement (30g: 10g per meal) of F-PROT (whey) or S-PROT (casein) or a Placebo', 'Placebo+MPT (PLA; n=19); 2) F-PROT+MPT', 'S-PROT+MPT', 'not mixed power training (MPT) combined with fast-digested PROT (F-PROT', 'Power training and protein (PROT) supplementation']","['LM, and lower limb MS/MQ, functional capacity, muscle characteristics and serum parameters', 'LM, handgrip and knee extensor MS and MQ, functional capacity, serum metabolic markers, skeletal muscle characteristics, dietary intake and total energy expenditure']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}]",60.0,0.0199228,"No difference was observed among groups for age, BMI, number of steps and dietary intake pre- and post-intervention.","[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Dulac', 'Affiliation': 'Département de Biologie, Faculté des sciences, Université du Québec à Montréal, Montréal (QC), Canada.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Pion', 'Affiliation': 'Département de Biologie, Faculté des sciences, Université du Québec à Montréal, Montréal (QC), Canada.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Lemieux', 'Affiliation': ""Département des sciences de l'activité physique, Faculté des sciences, Université du Québec à Montréal, Montréal (QC), Canada.""}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Carvalho', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal (QC), Canada.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'El Hajj Boutros', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal (QC), Canada.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bélanger', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal (QC), Canada.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gaudreau', 'Affiliation': ""'Department of Medicine, University of Montreal, Montréal (QC), Canada.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chevalier', 'Affiliation': 'McGill University Health Centre-Research Institute and Department of Medicine, McGill University, Montréal (QC), Canada.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Morais', 'Affiliation': 'McGill University Health Centre-Research Institute and Department of Medicine, McGill University, Montréal (QC), Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Noirez', 'Affiliation': ""Département des sciences de l'activité physique, Faculté des sciences, Université du Québec à Montréal, Montréal (QC), Canada.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gouspillou', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal (QC), Canada.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aubertin-Leheudre', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal (QC), Canada.""}]",The British journal of nutrition,['10.1017/S0007114520001932']
2887,32418886,Updated overall survival and final progression-free survival data for patients with treatment-naïve advanced ALK-positive non-small-cell lung cancer in the ALEX study.,"BACKGROUND
The ALEX study demonstrated significantly improved progression-free survival (PFS) with alectinib versus crizotinib in treatment-naïve ALK-positive non-small-cell lung cancer (NSCLC) at the primary data cut-off (9 February 2017). We report mature PFS (cut-off: 30 November 2018) and overall survival (OS) data up to 5 years (cut-off: 29 November 2019).
PATIENTS AND METHODS
Patients with stage III/IV ALK-positive NSCLC were randomized to receive twice-daily alectinib 600 mg (n = 152) or crizotinib 250 mg (n = 151) until disease progression, toxicity, withdrawal or death. Primary endpoint: investigator-assessed PFS. Secondary endpoints included objective response rate, OS and safety.
RESULTS
Mature PFS data showed significantly prolonged investigator-assessed PFS with alectinib (hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.32-0.58; median PFS 34.8 versus 10.9 months crizotinib). Median duration of OS follow-up: 48.2 months alectinib, 23.3 months crizotinib. OS data remain immature (37% of events). Median OS was not reached with alectinib versus 57.4 months with crizotinib (stratified HR 0.67, 95% CI 0.46-0.98). The 5-year OS rate was 62.5% (95% CI 54.3-70.8) with alectinib and 45.5% (95% CI 33.6-57.4) with crizotinib, with 34.9% and 9.3% of patients still on study treatment, respectively. The OS benefit of alectinib was seen in patients with central nervous system metastases at baseline (HR 0.58 [95% CI 0.34-1.00]) and those without (HR 0.76 [95% CI 0.45-1.26]). Median treatment duration was longer with alectinib (28.1 versus 10.8 months), and no new safety signals were observed.
CONCLUSIONS
Mature PFS data from ALEX confirmed significant improvement in PFS for alectinib over crizotinib in ALK-positive NSCLC. OS data remain immature, with a higher 5-year OS rate with alectinib versus crizotinib. This is the first global randomized study to show clinically meaningful improvement in OS for a next-generation tyrosine kinase inhibitor versus crizotinib in treatment-naïve ALK-positive NSCLC.",2020,"The 5-year OS rate was 62.5% (95% CI 54.3-70.8) with alectinib and 45.5% (95% CI 33.6-57.4) with crizotinib, with 34.9% and 9.3% of patients still on study treatment, respectively.","['patients with treatment-naïve advanced ALK-positive non-small-cell lung cancer in the ALEX study', 'patients with central nervous system metastases at baseline (HR 0.58', 'Patients with stage III/IV ALK-positive NSCLC']","['twice-daily alectinib 600 mg (n = 152) or crizotinib', 'alectinib versus crizotinib']","['overall survival (OS) data', 'Median duration of OS', 'Median OS', 'Updated overall survival and final progression-free survival data', 'Median treatment duration', 'objective response rate, OS and safety', '5-year OS rate', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3853921', 'cui_str': 'alectinib'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.315613,"The 5-year OS rate was 62.5% (95% CI 54.3-70.8) with alectinib and 45.5% (95% CI 33.6-57.4) with crizotinib, with 34.9% and 9.3% of patients still on study treatment, respectively.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': 'State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Shatin, NT, Hong Kong.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Department of Internal Medicine, Rogel Cancer Center/University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Catalan Institute of Oncology, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dziadziuszko', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'D-W', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pérol', 'Affiliation': 'Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'S-H I', 'Initials': 'SI', 'LastName': 'Ou', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Shaw', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bordogna', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Smoljanović', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hilton', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruf', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Noé', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland. Electronic address: solange.peters@chuv.ch.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.478']
2888,32500094,Impact of Ketorolac on Opioid Consumption after Knee Arthroscopy.,"Purpose
The objective of this study was to examine postoperative opioid consumption in outpatients undergoing knee arthroscopy after a single dose of intravenous ketorolac.
Methods
Patients ages 18-65 years old, weighing over 50kg and scheduled for knee arthroscopy were randomized to one of the four groups of preoperative ketorolac (0mg, 7.5mg, 15mg, 30mg). The primary outcome measured was postoperative opioid consumption. Secondary outcomes included visual analog scale pain scores, patient satisfaction scores, side effects and total postoperative anesthesia care unit time. Equivalency between ketorolac groups in opioid reduction relative to placebo was evaluated for each dose pair (7.5 vs. 15mg, 7.5 vs. 30mg, and 15 vs. 30mg). Linear regression models were used to examine associations between ketorolac dose with postoperative length of stay and patient satisfaction. A linear mixed model was used to evalaute the association between ketorolac dose and pain scores over time.
Results
A total of 112 patients with comparable patient and procedural characteristics were enrolled. Equivalency in opioid reduction relative to placebo was not demonstrated between any examined ketorlac doses (7.5 vs. 15mg, P = 0.167; 7.5 vs. 30mg, P = 0.451; 15 vs. 30mg, P = 0.515). Compared to placebo, all ketorlac doses decreased postoperative pain scores (global P=0.012). Patient satisfaction and postoperative duration did not vary with ketorolac dose.
Conclusions
Although all ketorolac doses decreased PACU pain scores, equivalency in PACU opioid reduction between ketorolac doses was not demonstrated.",2018,"Compared to placebo, all ketorlac doses decreased postoperative pain scores (global P=0.012).","['Methods\n\n\nPatients ages 18-65 years old, weighing over 50kg and scheduled for knee arthroscopy', '112 patients with comparable patient and procedural characteristics were enrolled', 'outpatients undergoing knee arthroscopy after a single dose of intravenous', 'after Knee Arthroscopy']","['Ketorolac', 'preoperative ketorolac', 'ketorolac', 'placebo']","['Opioid Consumption', 'pain scores', 'postoperative pain scores', 'PACU pain scores, equivalency in PACU opioid reduction', 'postoperative opioid consumption', 'Patient satisfaction and postoperative duration', 'visual analog scale pain scores, patient satisfaction scores, side effects and total postoperative anesthesia care unit time']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee joint'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",112.0,0.115964,"Compared to placebo, all ketorlac doses decreased postoperative pain scores (global P=0.012).","[{'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Wilson', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Slone', 'Affiliation': 'Department of Orthopedics, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Furse', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, USA.'}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Epperson', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]",Austin journal of anesthesia and analgesia,[]
2889,32500130,"Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.","OBJECTIVE
Perceived stress and musculoskeletal pain are common, especially in low-income populations. Studies evaluating treatments to reduce stress in patients with chronic pain are lacking. We aimed to quantify the effect of two evidence-based interventions for chronic low back pain (cLBP), yoga and physical therapy (PT), on perceived stress in adults with cLBP.
METHODS
We used data from an assessor-blinded, parallel-group randomized controlled trial, which recruited predominantly low-income and racially diverse adults with cLBP. Participants (N = 320) were randomly assigned to 12 weeks of yoga, PT, or back pain education. We compared changes in the 10-item Perceived Stress Scale (PSS-10) from baseline to 12- and 52-week follow-up among yoga and PT participants with those receiving education. Subanalyses were conducted for participants with elevated pre-intervention perceived stress (PSS-10 score ≥17). We conducted sensitivity analyses using various imputation methods to account for potential biases in our estimates due to missing data.
RESULTS
Among 248 participants (mean age = 46.4 years, 80% nonwhite) completing all three surveys, yoga and PT showed greater reductions in PSS-10 scores compared with education at 12 weeks (mean between-group difference = -2.6, 95% confidence interval [CI] = -4.5 to -0.66, and mean between-group difference = -2.4, 95% CI = -4.4 to -0.48, respectively). This effect was stronger among participants with elevated pre-intervention perceived stress. Between-group effects had attenuated by 52 weeks. Results were similar in sensitivity analyses.
CONCLUSIONS
Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.",2020,"CONCLUSIONS
Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.","['patients with chronic pain are lacking', '248 participants (mean age = 46.4 years, 80% nonwhite', 'adults with cLBP', 'recruited predominantly low-income and racially diverse adults with cLBP', 'Chronic Low Back Pain', 'Participants (N\u2009=\u2009320']","['Physical Therapy, and Education Interventions', 'Yoga and PT', 'yoga and physical therapy (PT']","['PSS-10 scores', '10-item Perceived Stress Scale (PSS-10', 'Perceived Stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",320.0,0.203356,"CONCLUSIONS
Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berlowitz', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Joyce', 'Affiliation': 'Department of Rehabilitation Science, Massachusetts General Hospital Institute of Health Professions, Boston, Massachusetts.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Fredman', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Saper', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roseen', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa150']
2890,32500131,Oral caffeine intake amplifies the effect of isoproterenol in patients with frequent premature ventricular contractions.,"AIMS
Infrequent appearance and failed induction of premature ventricular contractions (PVCs) at catheter ablation make their localization difficult and are associated with a poor procedural outcome. This study aimed to assess the effect of preprocedural oral caffeine intake on induction of PVCs during catheter ablation.
METHODS AND RESULTS
Seventy patients (age: 54 ± 14 years, 37 men) undergoing catheter ablation for monofocal PVCs were randomized to receive oral caffeine (5 mg/kg) or placebo. Before ablation, PVC counts for 5 min were performed at baseline and during isoproterenol infusion and the isoproterenol washout period. PVC count fluctuation was defined as the difference between the highest and lowest 5-min count among the three-time periods. The 5-min PVC counts during baseline and isoproterenol infusion were equivalent between the groups. However, those during the isoproterenol washout period and PVC count fluctuation were significantly higher in the caffeine group than the control group (73.1 ± 73.2 vs. 38.9 ± 28.9 beats/5 min, P = 0.012 and 69.3 ± 61.3 vs. 37.7 ± 30.9 beats/5 min, P = 0.008, respectively). The procedure and ablation times were significantly shorter in the caffeine group than the control group (105.0 ± 23.4 vs. 136.9 ± 43.2 min, P < 0.01 and 219.1 ± 104.7 vs. 283.5 ± 136.0 sec, P < 0.01, respectively).
CONCLUSION
Oral caffeine intake amplified the effect of isoproterenol infusion on PVC induction during catheter ablation. The combined use of oral caffeine intake and isoproterenol infusion can be an option to increase intraprocedural PVCs.",2020,"The procedure and ablation times were significantly shorter in the caffeine group than the control group (105.0 ± 23.4 vs. 136.9 ± 43.2 min, P < 0.01 and 219.1 ± ","['Seventy patients (age: 54\u2009±\u200914\u2009years, 37 men) undergoing catheter ablation for monofocal PVCs', 'patients with frequent premature ventricular contractions']","['oral caffeine', 'Oral caffeine', 'caffeine', 'preprocedural oral caffeine', 'isoproterenol infusion', 'isoproterenol', 'oral caffeine intake and isoproterenol infusion', 'placebo']","['procedure and ablation times', '5-min PVC counts', 'PVC count fluctuation']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0022245', 'cui_str': 'Isoproterenol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032624', 'cui_str': 'Polyvinyl chloride'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}]",70.0,0.0199067,"The procedure and ablation times were significantly shorter in the caffeine group than the control group (105.0 ± 23.4 vs. 136.9 ± 43.2 min, P < 0.01 and 219.1 ± ","[{'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Hasebe', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8575, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8575, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Furuyashiki', 'Affiliation': 'Division of Arrhythmology, Shizuoka Saiseikai General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Nogami', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8575, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ieda', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8575, Japan.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa069']
2891,32500154,The poor long-term outcomes of owl's eye pulmonary reconstruction technique after arterial switch operation.,"OBJECTIVES
This study aims to compare the early- and long-term outcomes of patients who undergo owl's eye pulmonary artery (PA) reconstruction to those of patients who undergo conventional PA reconstruction.
METHODS
From January 2016 to January 2017, 64 consecutive patients underwent an arterial switch operation. The patients were divided into 2 groups in terms of neo-PA reconstruction method: 30 patients who underwent neo-PA reconstruction by owl's eye technique were defined as group 1 and 34 patients who underwent neo-PA reconstruction by the conventional approach were defined as group 2. In the final model, after propensity matching, 23 patients from each group with similar propensity scores were included in the study.
RESULTS
There was no significant difference between the groups regarding patient characteristics and operative findings. In the early period, the duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS) were significantly higher in the owl's eye group (P = 0.04, 0.04 and 0.03). In the late period, the rate of severe neo-PS and reintervention was significantly higher in the owl's eye group (P = 0.02 and 0.04). Furthermore, the rates of 3-year freedom from pulmonary reintervention and freedom from moderate-severe neo-PS were significantly lower in group 1 (P = 0.04). In addition, the owl's eye reconstruction was the only factor independently related to moderate-severe neo-PS in the long term (hazard ratios = 11.2, P = 0.02).
CONCLUSIONS
We have abandoned the owl's eye method for neo-PA reconstruction of the neo-PA because of serious complications. According to our series and the literature, reconstruction of the neo-PA with an oversized, pantaloon-shaped fresh autologous pericardial patch is still superior to the other techniques.",2020,"In the early period, the duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS) were significantly higher in the owl's eye group (P = 0.04, 0.04 and 0.03).","['From January 2016 to January 2017, 64 consecutive patients underwent an arterial switch operation', ""patients who undergo owl's eye pulmonary artery (PA) reconstruction to those of patients who undergo conventional PA reconstruction"", '23 patients from each group with similar propensity scores were included in the study']","[""neo-PA reconstruction method: 30 patients who underwent neo-PA reconstruction by owl's eye technique were defined as group 1 and 34 patients who underwent neo-PA reconstruction by the conventional approach"", ""owl's eye pulmonary reconstruction technique after arterial switch operation""]","['duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS', 'rates of 3-year freedom from pulmonary reintervention and freedom from moderate-severe neo-PS', 'rate of severe neo-PS and reintervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0397344', 'cui_str': 'Arterial switch operation'}, {'cui': 'C0326066', 'cui_str': 'Family Strigidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0326066', 'cui_str': 'Family Strigidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0397344', 'cui_str': 'Arterial switch operation'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0034089', 'cui_str': 'Pulmonic valve stenosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",64.0,0.0188175,"In the early period, the duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS) were significantly higher in the owl's eye group (P = 0.04, 0.04 and 0.03).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Dedemoğlu', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Mersin City Training and Research Hospital, Mersin, Turkey.'}, {'ForeName': 'Oktay', 'Initials': 'O', 'LastName': 'Korun', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gültekin', 'Initials': 'G', 'LastName': 'Coşkun', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Özdemir', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Gazi Yaşargil Education and Research Hospital, Diyarbakır, Turkey.'}, {'ForeName': 'Okan', 'Initials': 'O', 'LastName': 'Yurdakök', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Çiçek', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Biçer', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Health Sciences University Erzurum Region Education and Research Hospital, Erzurum, Turkey.'}, {'ForeName': 'Nurgül', 'Initials': 'N', 'LastName': 'Yurtseven', 'Affiliation': 'Department of Anesthesia and Reanimation, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Şaşmazel', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Numan Ali', 'Initials': 'NA', 'LastName': 'Aydemir', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivaa067']
2892,32446979,"Xinyue Capsule in patients with stable coronary artery disease after percutaneous coronary intervention: a multicenter, randomized, placebo-controlled trial.","BACKGROUND
Xinyue capsule, a patented Chinese herbal medicine, has been used to manage coronary artery disease (CAD) for over a decade in China, but whether it can further reduce risk of cardiovascular events beyond conventional treatment is unknown.
METHODS
In this multicenter, randomized, placebo-controlled trial, we randomly assigned patients with stable CAD who underwent percutaneous coronary intervention (PCI) within the preceding 3-12 months to receive Xinyue capsule (100 mg panax quinquefolius saponins, three times a day) or placebo for 24 weeks in addition to conventional treatment. The primary endpoint was a composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting. The secondary composite endpoints included stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality. Quality of life was assessed using a 36-item Short-Form Health Survey (SF-36).
RESULTS
A total of 1054 participants were included in the analyses. The median follow up was 1 year. The primary endpoint events occurred in 16 patients (3.02%) in the Xinyue group and 34 patients (6.49%) in the placebo group (hazard ratio [HR] 0.455, 95% confidence interval [CI] 0.25 to 0.825; P = 0.009). Secondary end-point events occurred in 5.47% of patients in the Xinyue group and 10.31% in the placebo group (HR 0.515, 95% CI 0.328 to 0.809; P = 0.004). SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
CONCLUSIONS
In patients with stable CAD after PCI within the preceding 3 to 12 months, Xinyue capsule added on conventional treatment reduced the incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization).",2020,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","['patients with stable CAD who underwent', 'A total of 1054 participants were included in the analyses', 'patients with stable coronary artery disease after percutaneous coronary intervention']","['percutaneous coronary intervention (PCI', 'Xinyue capsule (100\u2009mg panax quinquefolius saponins, three times a day) or placebo', 'Xinyue Capsule', 'placebo']","['SF-36 subscale scores', 'Secondary end-point events', 'Quality of life', 'composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting', 'stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality', 'incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3651791', 'cui_str': 'Panax quinquefolius whole extract'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",1054.0,0.559087,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Changgeng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Qiaoning', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Zhuye', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of the Henan University of Chinese Medicine, Henan 450046, China.'}, {'ForeName': 'Shuzheng', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing 10029, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'The First Affiliated Hospital of Jilin University of Traditional Chinese Medicine, Changchun 130021, China.'}, {'ForeName': 'Tianchang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Naval General Hospital, Beijing 100048, China.'}, {'ForeName': 'Dazhuo', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China. Electronic address: shidazhuo@cacms.cn.'}, {'ForeName': 'For The Xy', 'Initials': 'FTX', 'LastName': 'Working Group', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}]",Pharmacological research,['10.1016/j.phrs.2020.104883']
2893,32447224,Shorter sleep duration is associated with lower GABA levels in the anterior cingulate cortex.,"BACKGROUND
Alterations in the levels of gamma-aminobutyric acid (GABA) and glutamate + glutamine (Glx), which are major inhibitory and excitatory neurotransmitters, respectively, are frequently associated with insomnia. Previous reports also suggested the involvement of the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration. In the current study, we investigated whether the GABA and Glx levels were altered in the ACC/mPFC in subclinical insomnia while focusing on the sleep duration.
METHODS
We examined levels of GABA and Glx in the ACC/mPFC of the brain with magnetic resonance spectroscopy in 166 individuals with subjective sleep complaints but without a diagnosis of insomnia. Participants were divided into two groups according to sleep duration (≥6 h/night: n = 79 vs. < 6 h/night: n = 74), which was measured using a wrist-worn actigraphy. Working memory function and overall subjective sleep quality were assessed with a computerized neuropsychological test and self-report questionnaire, respectively.
RESULTS
GABA levels in the ACC/mPFC were lower in the shorter sleep duration group relative to the longer sleep duration group (t = -2.21, p = 0.03). Glx levels did not differ between the two groups (t = -0.20, p = 0.84). Lower GABA levels were associated with lower spatial working memory performance in the shorter sleep duration group (β = -0.21, p = 0.03), but not the longer sleep duration group (β = 0.04, p = 0.72).
CONCLUSION
Shorter sleep duration was associated with lower GABA levels in the ACC/mPFC. These findings may provide insight into the underlying mechanisms of impaired working memory function related to insomnia and sleep loss.",2020,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).",['166 individuals with subjective sleep complaints but without a diagnosis of insomnia'],['magnetic resonance spectroscopy'],"['Shorter sleep duration', 'anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration', 'Glx levels', 'mPFC', 'Working memory function and overall subjective sleep quality', 'GABA levels', 'GABA and Glx levels', 'Lower GABA levels', 'spatial working memory performance']","[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",166.0,0.0321215,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).","[{'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Ilhyang', 'Initials': 'I', 'LastName': 'Kang', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russell H. Morgan Department of Radiology and Radiological Science, The Johns Hopkins University School of Medicine, Baltimore, MD, USA; F.M. Kirby Research Center for Functional Brain Imaging, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jinsol', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea. Electronic address: jungyoon.kimm@ewha.ac.kr.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.018']
2894,32448187,"A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study.","BACKGROUND
Delirium is very common in critically ill patients admitted to the intensive care unit (ICU) and results in negative long-term outcomes. Family members are also at risk of long-term complications, including depression and anxiety. Family members are frequently at the bedside and want to be engaged; they know the patient best and may notice subtle changes prior to the care team. By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care.
METHODS
The primary aim of this study is to determine the effect of family-administered delirium prevention, detection, and management in critically ill patients on family member symptoms of depression and anxiety, compared to usual care. One-hundred and ninety-eight patient-family dyads will be recruited from four medical-surgical ICUs in Calgary, Canada. Dyads will be randomized 1:1 to the intervention or control group. The intervention consists of family-partnered delirium prevention, detection, and management, while the control group will receive usual care. Delirium, depression, and anxiety will be measured using validated tools, and participants will be followed for 1- and 3-months post-ICU discharge. All analyses will be intention-to-treat and adjusted for pre-identified covariates. Ethical approval has been granted by the University of Calgary Conjoint Health Research Ethics Board (REB19-1000) and the trial registered. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.
DISCUSSION
Critically ill patients are frequently unable to participate in their own care, and partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families.
TRIAL REGISTRATION
Registered September 23, 2019 on Clinicaltrials.gov NCT04099472.",2020,"By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care.
","['One-hundred and ninety-eight patient-family dyads will be recruited from four medical-surgical ICUs in Calgary, Canada', 'Registered September 23, 2019 on Clinicaltrials.gov', 'critically ill adults', 'Critically ill patients', 'critically ill patients on family member symptoms of depression and anxiety, compared to usual care', 'critically ill patients admitted to the intensive care unit (ICU']",[],"['Delirium, depression, and anxiety']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.100765,"By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care.
","[{'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Fiest', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada. kmfiest@ucalgary.ca.'}, {'ForeName': 'Karla D', 'Initials': 'KD', 'LastName': 'Krewulak', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'Bonnie G', 'Initials': 'BG', 'LastName': 'Sept', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Spence', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Davidson', 'Affiliation': 'Department of Psychiatry, UC San Diego School of Medicine, San Diego, California, USA.'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': ""Tennessee Valley Veteran's Affairs Geriatric Research Education Clinical Center (VA GRECC), Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Soo', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Stelfox', 'Affiliation': 'Department of Critical Care Medicine, University of Calgary & Alberta Health Services, Calgary, Canada.'}]",BMC health services research,['10.1186/s12913-020-05281-8']
2895,32448257,"A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt.","BACKGROUND
Previous community-based research shows that secondary prevention of postpartum hemorrhage (PPH) with misoprostol only given to women with above-average measured blood loss produces similar clinical outcomes compared to routine administration of misoprostol for prevention of PPH. Given the difficulty of routinely measuring blood loss for all deliveries, more operational models of secondary prevention are needed.
METHODS
This cluster-randomized, non-inferiority trial included women giving birth with nurse-midwives at home or in Primary Health Units (PHUs) in rural Egypt. Two PPH management approaches were compared: 1) 600mcg oral misoprostol given to all women after delivery (i.e. primary prevention, current standard of care); 2) 800mcg sublingual misoprostol given only to women with 350-500 ml postpartum blood loss estimated using an underpad (i.e. secondary prevention). The primary outcome was mean change in pre- and post-delivery hemoglobin. Secondary outcomes included hemoglobin ≥2 g/dL and other PPH interventions.
RESULTS
Misoprostol was administered after delivery to 100% (1555/1555) and 10.7% (117/1099) of women in primary and secondary prevention clusters, respectively. The mean drop in pre- to post-delivery hemoglobin was 0.37 (SD: 0.91) and 0.45 (SD: 0.76) among women in primary and secondary prevention clusters, respectively (difference adjusted for clustering = 0.01, one-sided 95% CI: < 0.27, p = 0.535). There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions.
CONCLUSIONS
Misoprostol for secondary prevention of PPH is comparable to universal prophylaxis and can be implemented using local materials, such as underpads.
TRIAL REGISTRATION
Clinicaltrials.gov NCT02226588, date of registration 27 August 2014.",2020,"There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions.
","['women giving birth with nurse-midwives at home or in Primary Health Units (PHUs) in rural Egypt', 'postpartum hemorrhage among community level births in Egypt']","['Misoprostol', 'sublingual misoprostol', 'misoprostol']","['mean drop in pre- to post-delivery hemoglobin', 'hemoglobin drop ≥2\u2009g/dL, PPH diagnosis, transfer to higher level, or other interventions', 'mean change in pre- and post-delivery hemoglobin', 'hemoglobin ≥2\u2009g/dL and other PPH interventions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0028655', 'cui_str': 'Nurse-Midwife'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.355977,"There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions.
","[{'ForeName': 'Holly A', 'Initials': 'HA', 'LastName': 'Anger', 'Affiliation': 'Gynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA. hanger@gynuity.org.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Dabash', 'Affiliation': 'Gynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA.'}, {'ForeName': 'Nevine', 'Initials': 'N', 'LastName': 'Hassanein', 'Affiliation': 'Independent Reproductive Health Consultant, Cairo, Egypt.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Darwish', 'Affiliation': 'Faculty of Medicine, Alexandria University, 17 Champollion St, El Messalah, Alexandria, Egypt.'}, {'ForeName': 'Mohamed Cherine', 'Initials': 'MC', 'LastName': 'Ramadan', 'Affiliation': 'Department of Obstetrics and Gynecology, El Galaa Teaching Hospital, Cairo, Egypt.'}, {'ForeName': 'Medhat', 'Initials': 'M', 'LastName': 'Nawar', 'Affiliation': 'El Beheira Governorate, Ministry of Health and Population, Damanhour, Egypt.'}, {'ForeName': 'Dyanna', 'Initials': 'D', 'LastName': 'Charles', 'Affiliation': 'Gynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA.'}, {'ForeName': 'Miral', 'Initials': 'M', 'LastName': 'Breebaart', 'Affiliation': 'Independent Public Health Consultant, Cairo, Egypt.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Winikoff', 'Affiliation': 'Gynuity Health Projects, 220 E 42nd St, Suite 710, New York, NY, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03008-5']
2896,32448299,Acceptability and feasibility of a behavioral and mobile health intervention (COMBIND) shown to increase uptake of prevention of mother to child transmission (PMTCT) care in India.,"BACKGROUND
A cluster-randomized trial recently demonstrated that an integrated behavioral and mobile technology intervention improved uptake of key components of a Prevention of Mother to Child Transmission (PMTCT) Option B+ program, among HIV- infected pregnant/breastfeeding women in India. To guide scale-up and optimize programmatic implementation, we conducted a mixed-methods evaluation of the feasibility and acceptability of this intervention.
METHODS
The COMmunity Home Based INDia (COMBIND) study, was conducted in four districts of Maharashtra, India and randomized 119 integrated counseling and testing centers (ICTC) and their outreach workers (ORWs) to the COMBIND intervention, an integrated mHealth application that allowed digital data capture, PMTCT educational videos, SMS alerts for missed visits and reminder for visits, combined with personal empowerment and motivational interviewing training for ORWs. This qualitative evaluation was done through 15 in-depth interviews (IDIs) with ORWs and 15 IDIs with HIV-infected pregnant/breastfeeding women from the intervention arm. Utilizing a concurrent nested mixed-method evaluation approach, we assess the feasibility and acceptability of the study intervention.
RESULTS
All 30 participants reported that the PMTCT videos were essential in providing easy to understand information on critical aspects of HIV and necessary care related to PMTCT practices. A majority of the ORWs reported that the personal empowerment training with motivational interviewing skills training increased their confidence, motivation and gave them the tools for effectively supporting their clients. The mHealth application improved their working style as it facilitated targeted PMTCT information support, systemized data capture, streamlined their health education delivery practice and provided a sense of work satisfaction. The SMS appointment alerts improved retention in HIV care for mother and baby to the smaller proportion that had access to their phones. Despite reported improvements in knowledge and communication, few ORWs reported that structural challenges such as limited drug stocks, lack of HIV kits or unavailability of trained staff at ICTC, may hamper the uptake of PMTCT services, thus resulting in limited significant impacts of COMBIND on PMTCT outcomes.
CONCLUSION
This study found that COMBIND intervention is scalable, feasible, beneficial and very well accepted by ORWs and patients, however structural challenges in goods and services remain.",2020,All 30 participants reported that the PMTCT videos were essential in providing easy to understand information on critical aspects of HIV and necessary care related to PMTCT practices.,"['mother to child transmission (PMTCT) care in India', 'Mother to Child Transmission (PMTCT', 'four districts of Maharashtra, India and randomized 119 integrated counseling and testing centers (ICTC) and their outreach workers (ORWs) to the', 'HIV- infected pregnant/breastfeeding women in India', 'The COMmunity Home Based INDia']","['COMBIND intervention, an integrated mHealth application that allowed digital data capture, PMTCT educational videos, SMS alerts for missed visits and reminder for visits, combined with personal empowerment and motivational interviewing training for ORWs', 'behavioral and mobile health intervention (COMBIND']","['feasibility and acceptability', 'retention in HIV care']","[{'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",119.0,0.0351705,All 30 participants reported that the PMTCT videos were essential in providing easy to understand information on critical aspects of HIV and necessary care related to PMTCT practices.,"[{'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Suryavanshi', 'Affiliation': 'Lakshya Society for Public Health Education and Research, 307, Block II, Llyod Chambers, Mangalwar Peth, Pune, Maharashtra, 411001, India. nishisuryavanshi@hotmail.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Kadam', 'Affiliation': 'Lakshya Society for Public Health Education and Research, 307, Block II, Llyod Chambers, Mangalwar Peth, Pune, Maharashtra, 411001, India.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Kanade', 'Affiliation': 'Lakshya Society for Public Health Education and Research, 307, Block II, Llyod Chambers, Mangalwar Peth, Pune, Maharashtra, 411001, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bollinger', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Mave', 'Affiliation': 'Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shankar', 'Affiliation': 'Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.'}]",BMC public health,['10.1186/s12889-020-08706-5']
2897,32448331,"The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study protocol: a pragmatic, cluster, crossover trial.","BACKGROUND
Disruptive behavior in hospitalized patients has become a priority area of safety concern for clinical staff, and also has consequences for patient management and hospital course. Proactive screening and intervention of patients with behavioral comorbidities has been reported to reduce disruptive behavior in some settings, but it has not been studied in a rigorous way.
METHODS
The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study is a pragmatic, cluster, crossover trial that is being conducted. Each month, the behavioral intervention team, comprising a psychiatric-mental health advanced practice nurse and a clinical social worker, with psychiatrist consultation as needed, rotates between an adult medicine unit and a mixed cardiac unit at Vanderbilt University Medical Center in Nashville, TN, USA. The team proactively screens patients upon admission, utilizing a protocol which includes a comprehensive chart review and, if indicated, a brief interview, seeking to identify those patients who possess risk factors indicative of either a potential psychological barrier to their own clinical progress or a potential risk for exhibiting disruptive, aggressive, or self-injurious behavior during their hospitalization. Once identified, the team provides interventions aimed at mitigating these risks, educates and supports the patient care teams (nurses, physicians, and others), and assists non-psychiatric staff in the management of patients who require behavioral healthcare. Patients who are both admitted to and discharged from either unit are included in the study. Anticipated enrollment is approximately 1790 patients. The two primary outcomes are (1) a composite of objective measures related to the patients' disruptive, threatening, or acting out behaviors, and (2) staff self-reported comfort with and confidence in their ability to manage patients exhibiting disruptive, threatening, or acting out behavior. Secondary outcomes include patient length of stay, patient attendant (sitter) use, and the unit nursing staff retention.
DISCUSSION
This ongoing trial will provide evidence on the real-world effectiveness of a proactive behavioral intervention to prevent disruptive, threatening, or acting out events in adult hospitalized patients.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03777241. Registered on 14 December 2018.",2020,"The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study is a pragmatic, cluster, crossover trial that is being conducted.","['1790 patients', 'patients with behavioral comorbidities', 'hospitalized patients', 'adult hospitalized patients', 'psychiatric-mental health advanced practice nurse and a clinical social worker, with psychiatrist consultation as needed, rotates between an adult medicine unit and a mixed cardiac unit at Vanderbilt University Medical Center in Nashville, TN, USA', 'patients who require behavioral healthcare', 'Patients who are both admitted to and discharged from either unit are included in the study']","['Proactive screening and intervention', 'proactive behavioral intervention']","['patient length of stay, patient attendant (sitter) use, and the unit nursing staff retention', ""composite of objective measures related to the patients' disruptive, threatening, or acting out behaviors, and (2) staff self-reported comfort with and confidence in their ability to manage patients exhibiting disruptive, threatening, or acting out behavior""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001241', 'cui_str': 'Acting out - mental defense mechanism'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]",,0.0502974,"The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study is a pragmatic, cluster, crossover trial that is being conducted.","[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Hasselblad', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Kleinpell', 'Affiliation': 'Vanderbilt University School of Nursing, 461 21st Ave, 407 GH, Nashville, TN, 37240, USA. ruth.kleinpell@vanderbilt.edu.'}, {'ForeName': 'Reagan', 'Initials': 'R', 'LastName': 'Buie', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ariosto', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hardiman', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Osborn', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics and Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04278-2']
2898,32448624,"Infant antibody levels following 10-valent pneumococcal-protein D conjugate and DTaP-Hib vaccinations in the first year of life after maternal Tdap vaccination: An open-label, parallel, randomised controlled trial.","BACKGROUND
Maternal antibody levels after Tdap vaccination during pregnancy may affect infant primary antibody responses to pertussis, Tetanus toxoid (TT), Diphtheria toxoid (DT) vaccinations and pneumococcal vaccines with diphtheria toxin mutants like CRM197 as carrier protein.
METHODS
Mothers were recruited in an open label randomised parallel controlled trial in 2014-2016 through midwifes. They received Tdap [Boostrix] at 30-32 weeks of pregnancy (n = 58) or within 48 h after delivery (n = 60). Infants received DTaP-IPV-Hib-HepB [Infanrix Hexa] and 10-valent protein D conjugated pneumococcal conjugate vaccine (PHiD-CV10 [Synflorix]) at age 3, 5 and 11 months. We now report on infant specific IgG levels towards DT, TT, Haemophilus influenzae type b polyribosylribitol phosphate (Hib PRP) and PHiD-CV10 before and after primary- and booster vaccination as secondary study endpoints; pertussis antibodies were the primary endpoint of the study. This trial is registered in clinicaltrialsregister.eu (EudraCT 2012-004006-9) and trialregister.nl (NTR number NTR4314).
FINDINGS
Post primary vaccinations, antibody levels to DT, but not TT, were significantly lower after Tdap vaccination during pregnancy compared to controls (GMC ratio 0.4, 95% CI 0.3-0.6 and 0.9, 95% CI 0.6-1.2, respectively). Antibodies to serotype 19F were significantly lower in the maternal Tdap group, whereas there were no differences in antibody levels to Hib PRP and the other 9 pneumococcal serotypes. Post booster vaccinations, no significant differences were observed, except for DT.
INTERPRETATION
Maternal Tdap vaccination results in significant interference with infants responses not only to DT but also to conjugated pneumococcal vaccines containing DT mutants as carrier proteins. These interactions after maternal Tdap vaccination need to be taken into account when designing infants' national immunization schedules and choice of vaccines.
FUNDING
The Dutch Ministry of Health, Welfare and Sport.",2020,"Antibodies to serotype 19F were significantly lower in the maternal Tdap group, whereas there were no differences in antibody levels to Hib PRP and the other 9 pneumococcal serotypes.","['life after maternal Tdap vaccination', 'Mothers were recruited in an open label randomised parallel controlled trial in 2014-2016 through midwifes']","['10-valent pneumococcal-protein D conjugate and DTaP-Hib vaccinations', 'Tdap [Boostrix', 'DTaP-IPV-Hib-HepB [Infanrix Hexa] and 10-valent protein D conjugated pneumococcal conjugate vaccine (PHiD-CV10 [Synflorix', 'Tetanus toxoid (TT), Diphtheria toxoid (DT) vaccinations']","['Antibodies to serotype 19F', 'antibody levels to DT', 'antibody levels', 'Infant antibody levels']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}]","[{'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0018482', 'cui_str': 'Haemophilus infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1613021', 'cui_str': 'Boostrix'}, {'cui': 'C2716397', 'cui_str': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}, {'cui': 'C3661302', 'cui_str': 'Infanrix hexa'}, {'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0450819', 'cui_str': 'CV10'}, {'cui': 'C3252923', 'cui_str': 'synflorix'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.129252,"Antibodies to serotype 19F were significantly lower in the maternal Tdap group, whereas there were no differences in antibody levels to Hib PRP and the other 9 pneumococcal serotypes.","[{'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Barug', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'Berbers', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Marlies A', 'Initials': 'MA', 'LastName': 'van Houten', 'Affiliation': 'Department of Paediatrics, Spaarne Hospital, Hoofddorp, the Netherlands.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Kuijer', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Pronk', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Mirjam J', 'Initials': 'MJ', 'LastName': 'Knol', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.'}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands; Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, Utrecht, the Netherlands.""}, {'ForeName': 'Nynke Y', 'Initials': 'NY', 'LastName': 'Rots', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands. Electronic address: nynke.rots@rivm.nl.'}]",Vaccine,['10.1016/j.vaccine.2020.04.001']
2899,32448781,What is the feasibility and observed effect of two implementation packages for stroke rehabilitation therapists implementing upper limb guidelines? A cluster controlled feasibility study.,"BACKGROUND
Hand and arm activity after stroke improves with evidence-based rehabilitation. Therapists face known barriers when providing evidence-based rehabilitation and require support to implement guidelines. The aim of this study was to investigate the feasibility of two implementation packages on guideline adherence by occupational therapists and physiotherapists, and explore effect on patient upper limb outcomes.
METHOD
This was a non-randomised clustered feasibility study of occupational and physiotherapy rehabilitation services (n=3 inpatient and n=3 outpatient services). Services were allocated to one of three groups: (group A) facilitator-mediated implementation package, (group B) self-directed implementation package or (group C) usual care (control); we recruited n=1 inpatient and n=1 outpatient service per group. Outcomes of feasibility, adherence to guidelines (medical file audits) and patient upper limb impairment (Fugl-Meyer Upper Extremity Assessment), activity (Box and Block Test) and practice (minutes/week) were collected at baseline and after 3 months of intervention.
RESULTS
29 therapists (8 in group A, 13 in groups B and 8 in group C) and 55 patients participated. Both the facilitator-mediated and the self-directed implementation packages were feasible to deliver in the rehabilitation setting. Therapists in group A improved with respect to guideline adherence (medical file audits; median within-group proportion difference of 0.29 (95% CI 0.22 to 0.36, p<0.0001) preintervention to postintervention). No significant within-group differences from baseline to postintervention were found in group B or group C, and no between-group differences were found for upper limb outcomes.
CONCLUSION
A facilitator-mediated package was acceptable to therapists working in stroke rehabilitation, and feasibility data suggest increased guideline uptake following implementation. An adequately powered study is planned to understand how to support therapists to provide evidence-based upper limb rehabilitation after stroke.
TRIAL REGISTRATION NUMBER
Australian New Zealand Clinical Trials Registry (ACTRN12619000596101).",2020,"A facilitator-mediated package was acceptable to therapists working in stroke rehabilitation, and feasibility data suggest increased guideline uptake following implementation.",['n=3 inpatient and n=3 outpatient services'],"['occupational and physiotherapy rehabilitation services', 'facilitator-mediated implementation package, (group B) self-directed implementation package or (group C) usual care (control']","['feasibility, adherence to guidelines (medical file audits) and patient upper limb impairment (Fugl-Meyer Upper Extremity Assessment), activity (Box and Block Test) and practice (minutes/week', 'guideline adherence', 'upper limb outcomes']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0587660', 'cui_str': 'Rehabilitation service'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0574997,"A facilitator-mediated package was acceptable to therapists working in stroke rehabilitation, and feasibility data suggest increased guideline uptake following implementation.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jolliffe', 'Affiliation': 'Occupational Therapy, Alfred Health, Melbourne, Victoria, Australia l.jolliffe@alfred.org.au.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Lannin', 'Affiliation': 'Occupational Therapy, Alfred Health, Melbourne, Victoria, Australia.'}]",BMJ open quality,['10.1136/bmjoq-2020-000954']
2900,32448788,Effects of a multifactorial ecosustainable isocaloric diet on liver fat in patients with type 2 diabetes: randomized clinical trial.,"INTRODUCTION
Treatment options for non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes (T2D) are still a matter of debate. We compared the effects of a diet including different components versus a proven beneficial diet rich in monounsaturated fatty acids (MUFAs) on liver fat in T2D.
RESEARCH DESIGN AND METHODS
According to a parallel design, 49 individuals with T2D, overweight/obese, with high waist circumference, 35-75 years-old, in satisfactory blood glucose control with diet or drugs not affecting liver fat content, were randomly assigned to an 8-week isocaloric intervention with a MUFA diet (n=26) or a multifactorial diet rich in fiber, MUFA, n-6 and n-3 polyunsaturated fatty acids, polyphenols, and vitamins D, E, and C (n=23). Before and after the intervention, liver fat content was evaluated by proton magnetic resonance spectroscopy ( 1 H-MRS). 1 H-MRS complete data were available for n=21 (MUFA diet) and n=18 (multifactorial diet) participants.
RESULTS
Adherence to dietary interventions was optimal. No significant differences between groups in body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes were observed. Liver fat significantly decreased after both the multifactorial diet (9.18%±7.78% vs 5.22%±4.80%, p = 0.003) and the MUFA diet (9.47%±8.89% vs 8.07%±8.52%, p = 0.027) with a statistically significant difference between changes either in absolute terms (-4.0%±4.5% vs -1.4%±2.7%, p=0.035) or percent (-40%±33% vs -19%±25%, p=0.030).
CONCLUSIONS
An isocaloric multifactorial diet including several beneficial dietary components induced a clinically relevant reduction of liver fat in patients with T2D, more pronounced than that induced by simply replacing saturated fat with MUFA. This suggests that the 'optimal diet' for NAFLD treatment in T2D should be based on synergic actions of different dietary components on multiple pathophysiological pathways.
TRIAL REGISTRATION NUMBER
NCT03380416.",2020,"No significant differences between groups in body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes were observed.","['49 individuals with T2D, overweight/obese, with high waist circumference, 35-75\u2009years-old, in satisfactory blood glucose control with diet or drugs not affecting liver fat content', 'patients with T2D', 'patients with type 2 diabetes', 'patients with type 2 diabetes (T2D']","['isocaloric intervention with a MUFA diet (n=26) or a multifactorial diet rich in fiber, MUFA, n-6 and n-3 polyunsaturated fatty acids, polyphenols, and vitamins D, E, and C', 'multifactorial ecosustainable isocaloric diet', 'diet including different components versus a proven beneficial diet rich in monounsaturated fatty acids (MUFAs']","['liver fat', 'MUFA diet', 'Liver fat', 'body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes', 'liver fat content']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0456369', 'cui_str': 'Proven'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",49.0,0.0243611,"No significant differences between groups in body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes were observed.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Della Pepa', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vetrani', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Brancato', 'Affiliation': 'IRCCS SDN, Napoli, Campania, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Monti', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Napoli, Campania, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Annuzzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Izzo', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Tommasone', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cipriano', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Clemente', 'Affiliation': 'Institute for Research on Population and Social Policies, National Research Council, Fisciano, Italy.'}, {'ForeName': 'Peppino', 'Initials': 'P', 'LastName': 'Mirabelli', 'Affiliation': 'IRCCS SDN, Napoli, Campania, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Napoli, Campania, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Salvatore', 'Affiliation': 'IRCCS SDN, Napoli, Campania, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy rivelles@unina.it.'}, {'ForeName': 'Lutgarda', 'Initials': 'L', 'LastName': 'Bozzetto', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001342']
2901,32453377,"Safety, Tolerability, and Efficacy of Viltolarsen in Boys With Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping: A Phase 2 Randomized Clinical Trial.","Importance
An unmet need remains for safe and efficacious treatments for Duchenne muscular dystrophy (DMD). To date, there are limited agents available that address the underlying cause of the disease.
Objective
To evaluate the safety, tolerability, and efficacy of viltolarsen, a novel antisense oligonucleotide, in participants with DMD amenable to exon 53 skipping.
Design, Setting, and Participants
This phase 2 study was a 4-week randomized clinical trial for safety followed by a 20-week open-label treatment period of patients aged 4 to 9 years with DMD amenable to exon 53 skipping. To enroll 16 participants, with 8 participants in each of the 2 dose cohorts, 17 participants were screened. Study enrollment occurred between December 16, 2016, and August 17, 2017, at sites in the US and Canada. Data were collected from December 2016 to February 2018, and data were analyzed from April 2018 to May 2019.
Interventions
Participants received 40 mg/kg (low dose) or 80 mg/kg (high dose) of viltolarsen administered by weekly intravenous infusion.
Main Outcomes and Measures
Primary outcomes of the trial included safety, tolerability, and de novo dystrophin protein production measured by Western blot in participants' biceps muscles. Secondary outcomes included additional assessments of dystrophin mRNA and protein production as well as clinical muscle strength and function.
Results
Of the 16 included boys with DMD, 15 (94%) were white, and the mean (SD) age was 7.4 (1.8) years. After 20 to 24 weeks of treatment, significant drug-induced dystrophin production was seen in both viltolarsen dose cohorts (40 mg/kg per week: mean [range] 5.7% [3.2-10.3] of normal; 80 mg/kg per week: mean [range] 5.9% [1.1-14.4] of normal). Viltolarsen was well tolerated; no treatment-emergent adverse events required dose reduction, interruption, or discontinuation of the study drug. No serious adverse events or deaths occurred during the study. Compared with 65 age-matched and treatment-matched natural history controls, all 16 participants treated with viltolarsen showed significant improvements in timed function tests from baseline, including time to stand from supine (viltolarsen: -0.19 s; control: 0.66 s), time to run/walk 10 m (viltolarsen: 0.23 m/s; control: -0.04 m/s), and 6-minute walk test (viltolarsen: 28.9 m; control: -65.3 m) at the week 25 visit.
Conclusions and Relevance
Systemic treatment of participants with DMD with viltolarsen induced de novo dystrophin production, and clinical improvement of timed function tests was observed.
Trial Registration
ClinicalTrials.gov Identifier: NCT02740972.",2020,"Viltolarsen was well tolerated; no treatment-emergent adverse events required dose reduction, interruption, or discontinuation of the study drug.","['To enroll 16 participants, with 8 participants in each of the 2 dose cohorts, 17 participants were screened', 'Boys', '16 included boys with DMD, 15 (94%) were white, and the mean (SD) age was 7.4 (1.8) years', 'participants with DMD with', 'participants with DMD amenable to exon 53 skipping', 'patients aged 4 to 9 years with DMD amenable to exon 53 skipping', 'Data were collected from December 2016 to February 2018, and data were analyzed from April 2018 to May 2019', 'Exon 53 Skipping']","['viltolarsen', 'viltolarsen administered by weekly intravenous infusion']","['serious adverse events or deaths', 'additional assessments of dystrophin mRNA and protein production as well as clinical muscle strength and function', 'Safety, Tolerability, and Efficacy of Viltolarsen', ""safety, tolerability, and de novo dystrophin protein production measured by Western blot in participants' biceps muscles"", 'safety, tolerability, and efficacy', 'timed function tests', 'dystrophin production']","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005863', 'cui_str': 'Western Blotting'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",17.0,0.134131,"Viltolarsen was well tolerated; no treatment-emergent adverse events required dose reduction, interruption, or discontinuation of the study drug.","[{'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Clemens', 'Affiliation': 'Department of Neurology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vamshi K', 'Initials': 'VK', 'LastName': 'Rao', 'Affiliation': ""Division of Neurology, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Connolly', 'Affiliation': ""Division of Neurology, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus.""}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Harper', 'Affiliation': ""Children's Hospital of Richmond at Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Mah', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Smith', 'Affiliation': 'Division of Pediatric Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Department of Pediatrics, UC Davis Health, University of California, Davis, Sacramento.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Zaidman', 'Affiliation': 'Department of Neurology, Washington University at St Louis, St Louis, Missouri.'}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Morgenroth', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Osaki', 'Affiliation': 'NS Pharma, Paramus, New Jersey.'}, {'ForeName': 'Youhei', 'Initials': 'Y', 'LastName': 'Satou', 'Affiliation': 'NS Pharma, Paramus, New Jersey.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'NS Pharma, Paramus, New Jersey.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Hoffman', 'Affiliation': 'AGADA BioSciences, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.1264']
2902,32453383,Effect of Academic Detailing on Promoting Appropriate Prescribing of Antipsychotic Medication in Nursing Homes: A Cluster Randomized Clinical Trial.,"Importance
Strategies to reduce the inappropriate prescription of antipsychotics have been the focus of recent attention but have shown considerable variation in their effectiveness.
Objective
To evaluate the effectiveness of academic detailing in nursing homes targeting appropriate prescribing of antipsychotics.
Design, Setting, and Participants
We conducted a pragmatic, cluster randomized clinical trial comparing the effect of academic detailing vs usual care on prescribing antipsychotics in 40 nursing homes with 5363 residents in Ontario, Canada. Data were collected from October 2015 to March 2016 and analyzed from April to August 2018. Primary analyses were conducted using intention to treat.
Intervention
Academic detailing delivered by health professionals (eg, nurses or pharmacists) who arranged meetings (with administrators, physicians, pharmacists, nurses, and support workers), presentations, group visits (with 2-6 clinicians), and 1-on-1 visits (traditional academic detailing visits). Academic detailers had direct and ongoing contact with the nursing homes from the time of launch.
Main Outcomes and Measures
The primary outcome, defined at the level of the resident, was whether continuous antipsychotics were dispensed in the past week. Secondary outcomes included prescribing of other psychotropic medications and clinical outcomes and scores. Prescribing outcomes were assessed at baseline and at 3, 6, and 12 months, and clinical outcomes and scores were assessed at baseline and 3 and 6 months.
Results
A total of 40 nursing homes with 5363 residents were randomized, with 18 intervention homes (45.0%; 2303 [42.9%] residents) and 22 control homes (55.0%; 3060 [57.1%] residents). Participants in the intervention and control groups had similar median (interquartile range) age (86 [79-91] years vs 85 [78-90] years) and sex (674 [29.3%] men vs 970 [31.7%] men). At 12 months, there was no statistically significant difference in the frequency of daily antipsychotic use (intervention: 569 patients [25.2%]; control: 769 [25.6%]; odds ratio, 1.06; 95% CI, 0.93-1.20; P = .49). There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
Conclusions and Relevance
The intervention did not further reduce antipsychotic prescribing in nursing homes beyond system-level secular trends occurring alongside usual care. Our findings highlight the need for a more targeted approach to quality improvement strategies, including academic detailing, that account for the timing and topic of interventions.
Trial Registration
ClinicalTrials.gov Identifier: NCT02604056.",2020,"There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
","['Participants in the intervention and control groups had similar median (interquartile range) age (86 [79-91] years vs 85 [78-90] years) and sex (674 [29.3%] men vs 970 [31.7%] men', '40 nursing homes with 5363 residents were randomized, with 18 intervention homes (45.0%; 2303 [42.9%] residents) and 22 control homes (55.0%; 3060 [57.1%] residents', 'Data were collected from October 2015 to March 2016 and analyzed from April to August 2018', 'Nursing Homes', '40 nursing homes with 5363 residents in Ontario, Canada']","['academic detailing vs usual care on prescribing antipsychotics', 'Antipsychotic Medication', 'Academic Detailing', 'Intervention\n\n\nAcademic detailing delivered by health professionals (eg, nurses or pharmacists) who arranged meetings (with administrators, physicians, pharmacists, nurses, and support workers), presentations, group visits (with 2-6 clinicians), and 1-on-1 visits (traditional academic detailing visits']","['depression (mean [SD] Depression Rating Scale score', 'prescribing of other psychotropic medications and clinical outcomes and scores', 'frequency of daily antipsychotic use', 'pain', 'rates of health care utilization']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4517773', 'cui_str': '42.9'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1277251', 'cui_str': 'Has support worker'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",5363.0,0.142155,"There were no significant differences in the rates of health care utilization, but the intervention group did experience a statistically significant reduction in pain compared with the control group (mean [SD] pain score, 0.30 [0.59] vs 0.38 [0.66]; P < .001) and depression (mean [SD] Depression Rating Scale score, 2.18 [2.37] vs 2.81 [2.65]; P < .001) at 6 months.
","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Tadrous', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Kinwah', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Desveaux', 'Affiliation': ""Women's College Research Institute, Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Gomes', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'University of Ottawa School of Epidemiology, Public Health and Preventive Medicine, Ottawa, Ontario, Canada.'}, {'ForeName': 'Chaim M', 'Initials': 'CM', 'LastName': 'Bell', 'Affiliation': 'Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': 'ICES, Toronto, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.5724']
2903,32453406,Comparison of 3 Treatment Strategies for Medication Overuse Headache: A Randomized Clinical Trial.,"Importance
Medication overuse headache (MOH) is a disabling, globally prevalent disorder representing a well-known and debated clinical problem. Evidence for the most effective treatment strategy is needed.
Objective
To compare 3 treatment strategies for MOH.
Design, Setting, and Participants
This open-label, randomized clinical trial with 6 months of follow-up was conducted in the tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019. Of 483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding. Of these, 75 refused participation and 120 were included. Data were analyzed from July 3 to September 6, 2019.
Interventions
Random assignment (1:1:1 allocation) to 1 of the 3 outpatient treatments consisting of (1) withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal.
Main Outcomes and Measures
The primary outcome was change in headache days per month after 6 months. Predefined secondary outcomes were change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH.
Results
Of 120 patients, 102 (mean [SD] age, 43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up. Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20). No difference was found in reduction of migraine days per month, use of short-term medication, or headache intensity. In the withdrawal plus preventive group, 23 of 31 patients (74.2%) reverted to episodic headache, compared with 21 of 35 (60.0%) in the preventive group and 15 of 36 (41.7%) in the withdrawal group (P = .03). Moreover, 30 of 31 patients (96.8%) in the withdrawal plus preventive group were cured of MOH, compared with 26 of 35 (74.3%) in the preventive group and 32 of 36 (88.9%) in the withdrawal group (P = .03). These findings corresponded to a 30% (relative risk, 1.3; 95% CI, 1.1-1.6) increased chance of MOH cure in the withdrawal plus preventive group compared with the preventive group (P = .03).
Conclusion and Relevance
All 3 treatment strategies were effective, but based on these findings, withdrawal therapy combined with preventive medication from the start of withdrawal is recommended as treatment for MOH.
Trial Registration
ClinicalTrials.gov Identifier: NCT02993289.",2020,"Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20).","['120 patients, 102 (mean [SD] age', '43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up', 'Medication Overuse Headache', 'tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019', '483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding', '75 refused participation and 120 were included']","['withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal']","['chance of MOH cure', 'reduction of migraine days per month, use of short-term medication, or headache intensity', 'Headache days per month', 'change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH', 'episodic headache', 'change in headache days', 'cured of MOH']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C0039567', 'cui_str': 'Tertiary Sector'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",483.0,0.1209,"Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20).","[{'ForeName': 'Louise Ninett', 'Initials': 'LN', 'LastName': 'Carlsen', 'Affiliation': 'Currently a PhD student at the University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe Bruun', 'Initials': 'SB', 'LastName': 'Munksgaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Nielsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Ida Maria Storm', 'Initials': 'IMS', 'LastName': 'Engelstoft', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Maria Lurenda', 'Initials': 'ML', 'LastName': 'Westergaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bendtsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Rigmor Højland', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1179']
2904,32453449,Collaborative care for primary care treatment of late-life depression in Singapore: Randomized controlled trial.,"BACKGROUND
The effectiveness and portability of the collaborative care model in the primary care treatment of depression has not been demonstrated in many randomized controlled trials in healthcare settings across the world. We determined the effectiveness of collaborative care management of elderly depression in the primary care setting in Singapore.
METHOD
Eligible participants with depressive symptoms were randomized to 6-month duration usual care (UC, N = 112) or collaborative care (CC, N = 102). Outcome measures were HDRS-17, GDS, BDI and SF-12 MCS QOL measured at 3, 6, and 12-month, care satisfaction at 6-month, and also measured on 120 participants who refused referral (non-receipt of care, NC). Primary outcome was HDRS-17 measure of depression severity, response and remission at 6-month.
RESULTS
HDRS scores in CC group compared to UC group were reduced more at 6-month (1.5 points difference in change from baseline), and also at 3 and 12-month, with similar observations of differences for GDS and BDI. There was significantly greater improvement for both CC and UC groups compared to NC group. The CC group was about 1.5 times more likely to show HDRS treatment response and remission, and more than two times likely to show GDS treatment response and remission than the UC and NC groups, as well as better quality of life improvement (P < .001) and better care satisfaction (P < .001).
CONCLUSION
Collaborative care is effective for primary care treatment of older persons with depression and is portable in diverse health care settings.",2020,"RESULTS
HDRS scores in CC group compared to UC group were reduced more at 6-month","['older persons with depression', 'Primary Care Treatment of Late-Life Depression in Singapore', 'Eligible participants with depressive symptoms', 'elderly depression in the primary care setting in Singapore']","['collaborative care management', 'six-month duration usual care (UC, N\xa0=\xa0112) or collaborative care']","['care satisfaction', 'GDS treatment response and remission', 'HDRS scores', 'HDRS-17, GDS, BDI and SF-12 MCS QOL measured at 3-month, 6-month and 12-month, care satisfaction', 'quality of life improvement', 'HDRS-17 measure of depression severity, response and remission at 6-month', 'HDRS treatment response and remission']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.0983118,"RESULTS
HDRS scores in CC group compared to UC group were reduced more at 6-month","[{'ForeName': 'Tze Pin', 'Initials': 'TP', 'LastName': 'Ng', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Ma S Z', 'Initials': 'MSZ', 'LastName': 'Nyunt', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Calvin S L', 'Initials': 'CSL', 'LastName': 'Fones', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Soo Meng', 'Initials': 'SM', 'LastName': 'Ko', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}]",International journal of geriatric psychiatry,['10.1002/gps.5353']
2905,31806191,Cost-Effectiveness of Drug-Eluting Stents in Elderly Patients With Coronary Artery Disease: The SENIOR Trial.,"BACKGROUND
Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group.
OBJECTIVES
The objective of this article was to perform an economic evaluation of the SENIOR trial.
METHODS
This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping.
RESULTS
A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from €13 752 to €20 511/MACCE avoided and from €42 835 to €68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of €50 000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries.
CONCLUSION
The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.",2019,The number of MACCEs and average QALYs were not statistically different between the 2 groups.,"['1200 patients underwent randomization', 'Elderly patients receive', '5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values', 'elderly patients', 'Elderly Patients With Coronary Artery Disease']","['DES', 'DAPT', 'bare metal stents instead of drug-eluting stents (DES', 'Drug-Eluting Stents']","['number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE', '1-year incremental cost-effectiveness ratio', 'number of MACCEs and average QALYs', 'incremental cost-effectiveness ratio', 'Cost-Effectiveness', 'average total cost per patient', 'Costs, MACCEs, and quality-adjusted life-years (QALYs']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1200.0,0.0487237,The number of MACCEs and average QALYs were not statistically different between the 2 groups.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bulsei', 'Affiliation': ""AP-HP URC Eco IdF, Unité de recherche clinique en économie de la santé d'Ile de France, Paris, France. Electronic address: julie.bulsei@urc-eco.fr.""}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Butel', 'Affiliation': ""AP-HP URC Eco IdF, Unité de recherche clinique en économie de la santé d'Ile de France, Paris, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Varenne', 'Affiliation': 'AP-HP Hôpital Cochin, Paris, France; Cardiology Department, Université Paris Descartes, Sorbonne Paris-Cité, Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Cardiology Department, University and Hospital of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'Département de Cardiologie, Centre hospitalier universitaire Timone, Marseille, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'Service de Cardiologie, Centre hospitalier universitaire Toulouse Rangueil, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hovasse', 'Affiliation': 'Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy and Quincy, France.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Cardiovascular European Research Center, Massy, France.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""AP-HP URC Eco IdF, Unité de recherche clinique en économie de la santé d'Ile de France, Paris, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.07.008']
2906,31806193,Propensity Score Weighting Using Overlap Weights: A New Method Applied to Regorafenib Clinical Data and a Cost-Effectiveness Analysis.,"BACKGROUND
In situations of markedly different population characteristics and weak population overlap, inverse propensity score (PS) weights suffer from extreme values. The new propensity score weighting method using overlap weights (PSOW) overcomes this limitation by estimating the overlap population at the point of highest mutual overlap, thus may be preferred to other balancing methods (trimming, target, or inverse weights) in some situations.
OBJECTIVES
To evaluate the performance of PSOW with regorafenib effectiveness data from previously treated patients with metastatic colorectal cancer based on the Czech national registry data (regorafenib) and a global phase 3 randomized clinical trial (RCT) (placebo). The second goal was to assess the cost-effectiveness of regorafenib versus placebo.
METHODS
Individual data on progression-free survival (PFS)/overall survival (OS) were balanced via PSOW for age, sex, Eastern Cooperative Oncology Group performance status, number of treatment lines, metastatic colorectal cancer location, KRAS mutation, and time from metastases estimated using logistic regression. The weighted Kaplan-Meier PFS/OS curves were used in a 3-state partitioned survival model. The R code is provided.
RESULTS
In comparison with target or inverse PS weights, PSOW showed remarkable performance measured by effective sample size and PS weight distribution or extreme weights despite the weak overlap between the registry and RCT. In the registry or RCT cohort, regorafenib provided better survival compared with the RCT. The new PSOW hazard ratio for OS was 0.53 (RCT: 0.79), which is conservative compared with inverse or target weights with a hazard ratio of 0.44 and 0.27, respectively.
CONCLUSION
This is the first use of PSOW for clinical data and cost-effectiveness analysis. It is promising in cases of weak or small population overlap and makes pharmacoeconomic modeling, in such cases, feasible.",2019,The new PSOW hazard ratio for OS was 0.53,['previously treated patients with metastatic colorectal cancer based on the Czech national registry data (regorafenib) and a global phase 3 randomized clinical trial '],"['RCT) (placebo', 'regorafenib versus placebo']","['new PSOW hazard ratio for OS', 'Propensity Score Weighting Using Overlap Weights', 'progression-free survival (PFS)/overall survival (OS', 'survival', 'cost-effectiveness']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010871', 'cui_str': 'Czech language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.204898,The new PSOW hazard ratio for OS was 0.53,"[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Mlcoch', 'Affiliation': 'Value Outcomes, Prague, Czech Republic. Electronic address: tomas.mlcoch@valueoutcomes.cz.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Hrnciarova', 'Affiliation': 'Value Outcomes, Prague, Czech Republic; First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tuzil', 'Affiliation': 'Value Outcomes, Prague, Czech Republic; First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Zadak', 'Affiliation': 'Bayer, Prague, Czech Republic.'}, {'ForeName': 'Marisca', 'Initials': 'M', 'LastName': 'Marian', 'Affiliation': 'Bayer Pharmaceuticals, Basel, Switzerland.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Dolezal', 'Affiliation': 'Value Outcomes, Prague, Czech Republic; Faculty of Medicine, Masaryk University, Department of Pharmacology, Brno, Czech Republic.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.06.010']
2907,32450083,Randomized matrix games in a finite population: Effect of stochastic fluctuations in the payoffs on the evolution of cooperation.,"A diffusion approximation for a randomized 2 × 2-matrix game in a large finite population is ascertained in the case of random payoffs whose expected values, variances and covariances are of order given by the inverse of the population size N. Applying the approximation to a Randomized Prisoner's Dilemma (RPD) with independent payoffs for cooperation and defection in random pairwise interactions, conditions on the variances of the payoffs for selection to favor the evolution of cooperation, favor more the evolution of cooperation than the evolution of defection, and disfavor the evolution of defection are deduced. All these are obtained from probabilities of ultimate fixation of a single mutant. It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection. A RPD game with independent payoffs whose expected values are additive is studied in detail to support the conclusions. Randomized matrix games with non-independent payoffs, namely the RPD game with additive payoffs for cooperation and defection based on random cost and benefit for cooperation and the repeated RPD game with Tit-for-Tat and Always-Defect as strategies in pairwise interactions with a random number of rounds, are studied under the assumption that the population-scaled expected values, variances and covariances of the payoffs are all of the same small enough order. In the first model, the conditions in favor of the evolution of cooperation hold only if the covariance between the cost and the benefit is large enough, while the analysis of the second model extends the results on the effects of the variances of the payoffs for cooperation and defection found for the one-round RPD game.",2020,It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection.,[],[],[],[],[],[],,0.0254081,It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection.,"[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Département de mathématiques et de statistique, Université de Montréal, Montréal, Québec, H3C 3J7, Canada.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Lessard', 'Affiliation': 'Département de mathématiques et de statistique, Université de Montréal, Montréal, Québec, H3C 3J7, Canada. Electronic address: lessards@dms.umontreal.ca.'}]",Theoretical population biology,['10.1016/j.tpb.2020.04.006']
2908,32498098,Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial.,"BACKGROUND
The use of macroscopic on-site evaluation (MOSE) to estimate the adequacy of a specimen for histological diagnosis during endoscopic ultrasound (EUS)-guided fine-needle tissue acquisition (FNTA) has recently been advocated. This study aimed to evaluate the diagnostic yield of MOSE compared with conventional EUS-FNTA without rapid on-site evaluation (ROSE).
METHODS
This was an international, multicenter, prospective, randomized controlled study. After providing informed consent, consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2 cm were randomized to a MOSE arm or to a conventional arm without ROSE. A designated cytopathologist from each center performed all cytopathological examinations for that center and was blinded to the randomization results. The primary outcome measure was the diagnostic yield, and the secondary outcomes included sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications.
RESULTS
244 patients (122 conventional, 122 MOSE) were enrolled during the study period. No significant differences between the two arms were found in procedure time or rate of procedure-related adverse events. The diagnostic yield for the MOSE technique (92.6 %) was similar to that for the conventional technique (89.3 %; P = 0.37), with significantly fewer passes made (median: conventional 3, MOSE 2; P < 0.001).
CONCLUSIONS
EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes. This technique can be used when ROSE is not available.",2020,"CONCLUSIONS
EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes.","['244 patients (122 conventional, 122 MOSE) were enrolled during the study period', 'consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2\u200acm']","['conventional EUS-FNTA', 'MOSE', 'Endoscopic ultrasound-guided tissue acquisition with or without macroscopic', 'conventional arm without ROSE', 'endoscopic ultrasound (EUS)-guided fine-needle tissue acquisition (FNTA']","['sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications', 'procedure time or rate of procedure-related adverse events', 'diagnostic yield']","[{'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0441186', 'cui_str': 'Fine needle'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0441186', 'cui_str': 'Fine needle'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",244.0,0.133709,"CONCLUSIONS
EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes.","[{'ForeName': 'Charing C N', 'Initials': 'CCN', 'LastName': 'Chong', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Lakhtakia', 'Affiliation': 'Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.'}, {'ForeName': 'Nam', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Wah Kheong', 'Initials': 'WK', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Center, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medanta, The Medicity, Gurgaon, India.'}, {'ForeName': 'Majid A', 'Initials': 'MA', 'LastName': 'Almadi', 'Affiliation': 'Division of Gastroenterology, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tiing Leong', 'Initials': 'TL', 'LastName': 'Ang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kwek', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Yasuda', 'Affiliation': 'Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Kida', 'Affiliation': 'Department of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan.'}, {'ForeName': 'Hsiu-Po', 'Initials': 'HP', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tsu-Yao', 'Initials': 'TY', 'LastName': 'Cheng', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Aiming', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Anthony W H', 'Initials': 'AWH', 'LastName': 'Chan', 'Affiliation': 'Department of Anatomical and Cellular Pathology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Iwashita', 'Affiliation': 'First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Anthony Y B', 'Initials': 'AYB', 'LastName': 'Teoh', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}]",Endoscopy,['10.1055/a-1172-6027']
2909,31194885,Exposure-Response Analyses of Upadacitinib Efficacy in Phase II Trials in Rheumatoid Arthritis and Basis for Phase III Dose Selection.,"The relationships between upadacitinib, an oral selective Janus kinase 1 inhibitor, plasma exposures, and its efficacy (assessed by the American College of Rheumatology 20%/50%/70% responses over time) in moderate-to-severe active rheumatoid arthritis (RA) were characterized using data from 574 patients, on background methotrexate and inadequate response to methotrexate or anti-TNF therapy, from two phase II trials conducted with twice-daily dosing of an immediate-release formulation. The developed time-continuous Markov models were used to simulate efficacy of once-daily (q.d.). regimens of upadacitinib extended-release incorporating sources of uncertainty. Upadacitinib plasma concentrations associated with 15 and 30 mg extended-release q.d. doses were predicted to achieve that plateau of response across RA subpopulations. Results from these analyses provided the rationale that supported selection and de-risked evaluation of upadacitinib extended-release doses for the first time in >4,000 patients in five large phase III trials.",2019,Upadacitinib plasma concentrations associated with 15 and 30 mg extended-release q.d.,[],['methotrexate or anti-TNF therapy'],['Upadacitinib plasma concentrations'],[],"[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0290846,Upadacitinib plasma concentrations associated with 15 and 30 mg extended-release q.d.,"[{'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Klünder', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Camp', 'Affiliation': 'Immunology Clinical Development, AbbVie, North Chicago, Illinois, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, Illinois, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1543']
2910,31072856,Exploring psychiatrists' perspectives of working with patients with dissociative seizures in the UK healthcare system as part of the CODES trial: a qualitative study.,"OBJECTIVE
There is currently limited research exploring healthcare professionals' (HCPs) experiences of working with patients with dissociative seizures (DS). Existing studies do not focus on the role of psychiatrists in treating this complex condition. The objective of this study was to gain an understanding of UK-based psychiatrists' experiences of the DS patient group. Against the backdrop of a UK-wide randomised controlled trial (RCT), the focus was broadened to encompass issues arising in everyday practice with the DS patient group.
DESIGN, PARTICIPANTS AND METHODS
A qualitative study using semistructured interviews was undertaken with 10 psychiatrists currently working with DS patients within the context of a large RCT investigating treatments for DS. Thematic analysis was used to identify key themes and subthemes.
SETTING
The psychiatrists were working in Liaison or Neuropsychiatry services in England.
RESULTS
The key themes identified were other HCPs' attitudes to DS and the challenges of the DS patient group. There is a clear knowledge gap regarding DS for many HCPs and other clinical services can be reluctant to take referrals for this patient group. Important challenges posed by this patient group included avoidance (of difficult emotions and help), alexithymia and interpersonal difficulties. Difficulties with alexithymia meant DS patients could struggle to identify triggers for their seizures and to express their emotions. Interpersonal difficulties raised included difficulties in attachment with both HCPs and family members.
CONCLUSIONS
A knowledge gap for HCPs regarding DS has been identified and needs to be addressed to improve patient care. Given the complexity of the patient group and that clinicians from multiple disciplines will come into contact with DS patients, it is essential for any educational strategy to be implemented across the whole range of specialties, and to account for those already in practice as well as future trainees.
TRIAL REGISTRATION NUMBER
ISRCTN05681227; NCT02325544; Pre-results.",2019,There is a clear knowledge gap regarding DS for many HCPs and other clinical services can be reluctant to take referrals for this patient group.,"['patients with dissociative seizures (DS', ""UK-based psychiatrists' experiences of the DS patient group"", 'The psychiatrists were working in Liaison or Neuropsychiatry services in England', '10 psychiatrists currently working with DS patients within the context of a large RCT investigating treatments for DS']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0870956', 'cui_str': 'Neuropsychiatry'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],[],,0.0549785,There is a clear knowledge gap regarding DS for many HCPs and other clinical services can be reluctant to take referrals for this patient group.,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Jordan', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Feehan', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': ""Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2018-026493']
2911,32498771,The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial.,"OBJECTIVE
To report the first randomized controlled trial to investigate if immersive virtual reality (VR) treatment can reduce patient perceptions of anxiety compared with a tablet-based control treatment in adults undergoing a first-time sternotomy.
METHODS
Twenty first-time sternotomy patients were prospectively randomized (blinded to investigator) to a control or VR intervention. The VR intervention was a game module ""Bear Blast"" (AppliedVR) displayed using a Samsung Gear Oculus VR headset. The control intervention was a tablet-based game with comparable audio, visual, and tactile components. The State-Trait Anxiety Inventory was administered before and after the assigned intervention. Self-reported anxiety measures between the control and VR groups were evaluated using an unpaired t test. Changes in self-reported anxiety measures pre- and post-intervention were evaluated with a paired t test for both the control and VR groups. The study took place from May 1, 2017, through January 1, 2019 (Institutional Review Board 16-009784).
RESULTS
Both control and VR groups were 90.0% male, with a mean ± SD age of 63.4 ± 9.11 and 69.5 ± 6.9 years, respectively. VR users experienced significant reductions in feeling tense and strained, and significant improvements in feeling calm when compared with tablet controls (P<0.05). They also experienced significant reductions in feeling strained, upset, and tense when compared with their own self-reported anxiety measure pre- and post-intervention (P<0.05). Critically, control patients had no change in these categories.
CONCLUSION
Immersive VR is an effective, nonpharmacologic approach to reducing preoperative anxiety in adults undergoing cardiac surgery and shows the validity and utility of this technology in adult patients.",2020,"VR users experienced significant reductions in feeling tense and strained, and significant improvements in feeling calm when compared with tablet controls (P<0.05).","['First-Time Sternotomy Patients', 'Twenty first-time sternotomy patients', 'adults undergoing a first-time sternotomy', 'adult patients', 'adults undergoing cardiac surgery']","['Immersive VR', 'Virtual Reality', 'control intervention was a tablet-based game with comparable audio, visual, and tactile components', 'immersive virtual reality (VR) treatment', 'control or VR intervention']","['feeling calm', 'Self-reported anxiety measures', 'patient perceptions of anxiety', 'Preoperative Anxiety', 'preoperative anxiety', 'State-Trait Anxiety Inventory']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0522165', 'cui_str': 'Feeling calm'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",,0.0319872,"VR users experienced significant reductions in feeling tense and strained, and significant improvements in feeling calm when compared with tablet controls (P<0.05).","[{'ForeName': 'Tina M', 'Initials': 'TM', 'LastName': 'Hendricks', 'Affiliation': 'Mayo Clinic Alix School of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Claudia N', 'Initials': 'CN', 'LastName': 'Gutierrez', 'Affiliation': 'Mayo Clinic Alix School of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Stulak', 'Affiliation': 'Department of Cardiovascular Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Dearani', 'Affiliation': 'Department of Cardiovascular Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Miller', 'Affiliation': 'Department of Cardiovascular Surgery, Mayo Clinic, Rochester, MN; Departments of Surgery and Physiology & Biomedical Engineering, Mayo Clinic, Rochester, MN. Electronic address: Miller.jordan@mayo.edu.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2020.02.032']
2912,32498930,Metformin intervention against ovarian toxicity during chemotherapy for early breast cancer: Study protocol for a randomized double-blind placebo-controlled trial.,"BACKGROUND
With the significant improvement of the cure rate and survival rate of cancer patients, the survivors face quality-of-life problems, such as a significant decline in reproductive system development, ovarian reserves and function, and even fertility loss and early menopause. These problems are often highly associated with chemotherapy-induced ovarian damage in cancer treatment. However, there are no ideal treatment strategies at present. In our attempt to develop reagents and approaches for delaying ovarian aging and protecting chemotherapy-induced ovarian injury, we recently found that metformin may be the most promising drug to protect female malignant tumor patients from chemotherapy-induced ovarian injury. This trial aims to test whether administration of metformin during chemotherapy can protect the normal ovarian function of patients with early breast cancer.
METHODS
This study is prospective, randomized, double-blind and placebo-controlled. Female patients with early breast cancer (N = 314) will be randomly assigned to two groups (placebo, metformin 2000 mg). Metformin will be administered during and after chemotherapy for patients with stage I-IIIa breast cancer. The primary outcome will be the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year. Patients will be followed up for 5 years to observe long-term ovarian function and prognosis, such as overall survival (OS), objective response rate (ORR), and disease-free survival (DFS). Quality of life and safety will also be assessed.
DISCUSSION
Our research will provide a new treatment strategy for fertility protection, and clinical treatment guidance for cancer patients.",2020,"The primary outcome will be the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year.","['patients with stage I-IIIa breast cancer', 'cancer patients', 'Female patients with early breast cancer (N = 314', 'early breast cancer', 'female malignant tumor patients from chemotherapy-induced ovarian injury', 'patients with early breast cancer']","['placebo, metformin', 'Metformin', 'metformin', 'Metformin intervention', 'chemotherapy', 'placebo']","['ovarian toxicity', 'Quality of life and safety', 'cure rate and survival rate', 'menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year', 'overall survival (OS), objective response rate (ORR), and disease-free survival (DFS', 'normal ovarian function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C4324589', 'cui_str': 'Ovarian injury'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",314.0,0.583759,"The primary outcome will be the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year.","[{'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Panshi', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Breast Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Cui', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Minli', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Xingrui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Breast Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China. Electronic address: lixingrui@tjh.tjmu.edu.cn.'}, {'ForeName': 'Shixuan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China. Electronic address: sxwang@tjh.tjmu.edu.cn.'}]",Maturitas,['10.1016/j.maturitas.2020.04.010']
2913,32498932,Effects of a patient-centered program including the cumulative-complexity model in women with chronic pelvic pain: a randomized controlled trial.,"OBJECTIVES
To evaluate the effects of a patient-centered intervention including the cumulative-complexity model on quality of life related to health, coping behaviors, pain, self-perceived occupational performance and activity levels.
STUDY DESIGN
Randomized controlled trial. Forty-four women with a clinical diagnosis of chronic pelvic pain were randomized into two groups. Patients in the experimental group (n = 22) were included in a patient-centered intervention that involved relevant activities proposed by participants. Patients in the control group (n = 22) received a leaflet with information about chronic pelvic pain, physical activity, fear of movement, false beliefs, active lifestyle and behavioral advice.
MAIN OUTCOME MEASURES
The primary outcome measures were health-related quality of life assessed with the EuroQol-5D and coping behavior using the Coping Strategies Questionnaires. Secondary outcomes included severity of pain using a Visual Analogue Scale, self-perception of occupational performance using the Canadian Occupational Performance Measure and physical activity levels assessed by the International Physical Activity Questionnaire.
RESULTS
An analysis of variance with repeated measures showed, in the experimental group compared with the control group, significantly greater improvement from baseline to post-intervention in health-related quality of life (EuroQol-5D Visual Analog Scale values of 70.06 ± 16.44 vs. 57.38 ± 16.40, p = 0.026) and coping behavior (adaptive coping 113.00 ± 31.89 vs. 83.24 ± 16.69, p = 0.002). Pain, self-perception of performance and physical activity levels also significantly improved.
CONCLUSIONS
A patient-centered intervention considering the workload of patients and their capacity for performing health behaviors provides benefits regarding quality of life and coping behavior. Additionally, pain, self-perceived performance of relevant tasks and physical activity levels improved.",2020,"An analysis of variance with repeated measures showed, in the experimental group compared with the control group, significantly greater improvement from baseline to post-intervention in health-related quality of life (EuroQol-5D Visual Analog Scale values of 70.06 ± 16.44 vs. 57.38 ± 16.40, p = 0.026) and coping behavior (adaptive coping 113.00 ± 31.89 vs. 83.24 ± 16.69, p = 0.002).","['women with chronic pelvic pain', 'Forty-four women with a clinical diagnosis of chronic pelvic pain', 'Patients in the experimental group (n = 22']","['patient-centered program', 'patient-centered intervention', 'leaflet with information about chronic pelvic pain, physical activity, fear of movement, false beliefs, active lifestyle and behavioral advice']","['quality of life related to health, coping behaviors, pain, self-perceived occupational performance and activity levels', 'health-related quality of life (EuroQol-5D Visual Analog Scale values', 'coping behavior', 'Pain, self-perception of performance and physical activity levels', 'severity of pain using a Visual Analogue Scale, self-perception of occupational performance using the Canadian Occupational Performance Measure and physical activity levels assessed by the International Physical Activity Questionnaire', 'pain, self-perceived performance of relevant tasks and physical activity levels', 'health-related quality of life assessed with the EuroQol-5D and coping behavior using the Coping Strategies Questionnaires']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",44.0,0.117721,"An analysis of variance with repeated measures showed, in the experimental group compared with the control group, significantly greater improvement from baseline to post-intervention in health-related quality of life (EuroQol-5D Visual Analog Scale values of 70.06 ± 16.44 vs. 57.38 ± 16.40, p = 0.026) and coping behavior (adaptive coping 113.00 ± 31.89 vs. 83.24 ± 16.69, p = 0.002).","[{'ForeName': 'Mª José', 'Initials': 'MJ', 'LastName': 'Ariza-Mateos', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cabrera-Martos', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain. Electronic address: irenecm@ugr.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rodríguez-Torres', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Torres-Sánchez', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Marie Carmen', 'Initials': 'MC', 'LastName': 'Valenza', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}]",Maturitas,['10.1016/j.maturitas.2020.04.005']
2914,32499826,"The effect of a lifestyle management educational program on blood pressure, heart rate, and body mass index in patients with hypertension.","BACKGROUND
Hypertension (HTN) is one of the most prevalent risk factors for arteriosclerosis and coronary artery disease (CAD). Its side effects can be decreased through the use of some methods and interventions. The present study was conducted with the aim to evaluate the effects of a lifestyle management on blood pressure, heart rate, and body mass index (BMI) of patients with HTN who have undergone angioplasty.
METHODS
This clinical trial was conducted on 2 groups in 3 stages in an educational hospital in Isfahan, Iran, in 2014. The study participants consisted of 60 patients with HTN who had undergone angioplasty. The participants were randomly allocated to the study and control groups. The intervention was implemented in 6 educational sessions during 3 weeks, and then, follow-up was conducted through phone calls in the study group. The collected data were analyzed using independent t-test, chi-square, Mann-Whitney U test, and ANOVA in SPSS software.
RESULTS
Repeated measures ANOVA results indicated that the effect of time (P < 0.001) and group (P = 0.027) on systolic blood pressure (SBP) was significant. The effect of time (P = 0.015) and group (P = 0.040) on diastolic blood pressure (DBP) was also significant. In terms of BMI, both effects of time (P = 0.010) and group (P = 0.034) were significant. However, the effect of time (P = 0.899) and group (P = 0.900) on heart rate was not significant.
CONCLUSION
The lifestyle management program implemented in the present study was effective on decreased DBP, SBP, and BMI in patients with HTN who had undergone angioplasty. Thus, nurses could implement this program as a part of their care provision program for patients.",2020,"However, the effect of time (P = 0.899) and group (P = 0.900) on heart rate was not significant.
","['patients with HTN who had undergone angioplasty', 'patients with HTN who have undergone angioplasty', 'patients with hypertension', '2 groups in 3 stages in an educational hospital in Isfahan, Iran, in 2014', '60 patients with HTN who had undergone angioplasty']","['lifestyle management', 'lifestyle management educational program']","['blood pressure, heart rate, and body mass index', 'heart rate', 'blood pressure, heart rate, and body mass index (BMI', 'systolic blood pressure (SBP', 'DBP, SBP, and BMI', 'diastolic blood pressure (DBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",60.0,0.0194534,"However, the effect of time (P = 0.899) and group (P = 0.900) on heart rate was not significant.
","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Shahriari', 'Affiliation': 'Associate Professor, Nursing and Midwifery Care Research Center AND Department of Adult Health Nursing, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fakhri', 'Initials': 'F', 'LastName': 'Sabouhi', 'Affiliation': 'Department of Adult Health Nursing, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khosravi-Farsani', 'Affiliation': 'Interventional Cardiology Research Center, Cardiovascular Research Institute AND Department of Cardiology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Eghbali-Babadi', 'Affiliation': 'Assistant Professor, Hypertension Research Center, Cardiovascular Research Institute AND Department of Intensive Nursing, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",ARYA atherosclerosis,['10.22122/arya.v16i1.1502']
2915,32499828,Effect of single-dose crystalloid cardioplegic agent compared to bloody cardioplegic agent in cardiac surgery in children with Tetralogy of Fallot.,"BACKGROUND
Cardioplegia is one of the main post-operative cardiac protective factors widely used in recent decades in the form of crystalloid (St. Thomas) and bloody solutions [del Nido (DN)]. The purpose of this study was to compare the effect of a crystalloid cardioplegic agent (St. Thomas) with that of a bloody cardioplegic agent (DN) in pediatric cardiac surgery among children with Tetralogy of Fallot (TOF).
METHODS
This study was performed on 60 children with TOF, who were candidates for heart repair surgery. The participants were randomly divided into two groups of crystalloid cardioplegic agent and bloody cardioplegic agent. Operative outcomes such as required time for onset of heart arrest, duration of returning to normal heart rhythm, and cardiopulmonary bypass (CPB) time, and operative complications were compared between the two groups.
RESULTS
The duration of returning to normal heart rhythm (50.43 ± 10.93 seconds vs. 43.03 ± 16.35 seconds; P = 0.044) and duration of inotropy (80.40 ± 27.14 hours vs. 63.20 ± 26.91 hours; P = 0.017) were significantly higher in the DN group compared to the St. Thomas group. However, there were no significant differences between the two groups in terms of heart arrest time, cross-clamp time, CPB time, supplementary lasix time, duration of intubation, and intensive care unit (ICU) and hospital length of stay (LOS) (P > 0.050).
CONCLUSION
The use of St. Thomas cardioplegic solution was more effective in reducing the duration of returning to normal heart rhythm and inotropy compared with DN cardioplegic agent, and a single dose of these two cardioplegic agents can keep the mean cardiac arrest duration within the range of 50-70 minutes. It seems that the use of St. Thomas cardioplegic solution can be suggested in pediatric heart surgery.",2020,"However, there were no significant differences between the two groups in terms of heart arrest time, cross-clamp time, CPB time, supplementary lasix time, duration of intubation, and intensive care unit (ICU) and hospital length of stay (LOS) (P > 0.050).
","['pediatric cardiac surgery among children with Tetralogy of Fallot (TOF', 'children with Tetralogy of Fallot', '60 children with TOF, who were candidates for heart repair surgery']","['crystalloid cardioplegic agent (St. Thomas) with that of a bloody cardioplegic agent (DN', 'crystalloid cardioplegic agent and bloody cardioplegic agent', 'single-dose crystalloid cardioplegic agent']","['heart arrest time, cross-clamp time, CPB time, supplementary lasix time, duration of intubation, and intensive care unit (ICU) and hospital length of stay (LOS', 'Operative outcomes such as required time for onset of heart arrest, duration of returning to normal heart rhythm, and cardiopulmonary bypass (CPB) time, and operative complications', 'mean cardiac arrest duration', 'duration of returning to normal heart rhythm']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0189919', 'cui_str': 'Repair of heart'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time'}, {'cui': 'C0699992', 'cui_str': 'Lasix'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0558288', 'cui_str': 'As required'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0342499,"However, there were no significant differences between the two groups in terms of heart arrest time, cross-clamp time, CPB time, supplementary lasix time, duration of intubation, and intensive care unit (ICU) and hospital length of stay (LOS) (P > 0.050).
","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Bigdelian', 'Affiliation': 'Associate Professor, Department of Cardiac Surgery, School of Medicine AND Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'Assistant Professor, Department of Cardiac Surgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",ARYA atherosclerosis,['10.22122/arya.v16i1.1943']
2916,32499875,Recurrent metastatic clear cell renal carcinoma with sarcomatoid dedifferentiation treated with surgery and Cabozantinib.,"Renal cell carcinoma with sarcomatoid dedifferentiation is an entity of RCC that has undergone an anaplastic transformation with both a carcinomatous and a sarcomatous component. The standard treatment in metastatic patients is immunotherapy. The aim of this article is to describe our case of metastatic recurrent RCC with sarcomatoid dedifferentiation in a 59 year old male patient treated with nephrectomy and multiple metastasectomies followed by Cabozantinib. Consecutive PET-CT scans showed no evidence of recurrence, three years after the last metastasectomy, and the patient is having currently a normal life. Sarcomatoid dedifferentiation remains a poor prognosis factor in RCC. Surgery for metastases followed by Cabozantinib may be a therapeutic option in metastatic young patients. However, a prospective randomized trial would be the best option to validate this approach.",2020,"Consecutive PET-CT scans showed no evidence of recurrence, three years after the last metastasectomy, and the patient is having currently a normal life.","['Recurrent metastatic clear cell renal carcinoma with sarcomatoid dedifferentiation treated with surgery and Cabozantinib', 'metastatic patients', 'metastatic young patients', '59 year old male patient treated with']",['nephrectomy and multiple metastasectomies followed by Cabozantinib'],[],"[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0002793', 'cui_str': 'Dedifferentiation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}]",[],,0.0221362,"Consecutive PET-CT scans showed no evidence of recurrence, three years after the last metastasectomy, and the patient is having currently a normal life.","[{'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Boustany', 'Affiliation': 'Notre Dame des Secours University Hospital Center (CHUNDS), Byblos City, Lebanon.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Abdessater', 'Affiliation': 'Notre Dame des Secours University Hospital Center (CHUNDS), Byblos City, Lebanon.'}, {'ForeName': 'Charbel El', 'Initials': 'CE', 'LastName': 'Hachem', 'Affiliation': 'Notre Dame des Secours University Hospital Center (CHUNDS), Byblos City, Lebanon.'}, {'ForeName': 'Ziad El', 'Initials': 'ZE', 'LastName': 'Khoury', 'Affiliation': 'Notre Dame des Secours University Hospital Center (CHUNDS), Byblos City, Lebanon.'}, {'ForeName': 'Walid El', 'Initials': 'WE', 'LastName': 'Khoury', 'Affiliation': 'Notre Dame des Secours University Hospital Center (CHUNDS), Byblos City, Lebanon.'}, {'ForeName': 'Raghid El', 'Initials': 'RE', 'LastName': 'Khoury', 'Affiliation': 'Notre Dame des Secours University Hospital Center (CHUNDS), Byblos City, Lebanon.'}]",Oncotarget,['10.18632/oncotarget.27543']
2917,32499879,A randomized controlled trial on Aspirin and complex regional pain syndrome after radius fractures.,"Complex regional pain syndrome (CRPS) is often diagnosed in patients who are recovered with surgery or injury. CRPS is usually diagnosed in patients recovering from distal radius fractures. The aim of study was the effects of aspirin in prevention of the complex regional pain syndrome (CRPS) following a fracture of distal radius. In a double-blind, randomized controlled trial, 91 patients with unilateral extra-articular distal radius fractures were randomly allocated to receive either placebo (PLA) or 500 mg of aspirin (ASA) daily for 7 days. The effect of aspirin on the occurrence of CRPS was evaluated. The patients were assessed clinically and radiographically in the second, fourth and twelfth weeks by a physician who was unaware of the treatment allocation. Ninety-one patients (ASA, n=44; PLA, n=47) were enrolled in the study. The prevalence of CRPS in all patients was 16.5%. The prevalence of CRPS in the aspirin group was lower (13.6%) than the placebo group (19.1%), but this difference was not statistically significant. The only significant difference was the lower rate of regional osteoporosis seen in the radiographs of aspirin group. Mean age was significantly higher in the patients with CRPS. Also, comminuted distal radius fractures (A3-type) were significantly more common in the patients with CRPS. Administration of aspirin in patients with a distal radius fracture was associated with a lower incidence of CRPS, but, not statistically significant. Further investigations needs to be done with a larger sample size, longer follow-up period and multi-center design.",2020,"Administration of aspirin in patients with a distal radius fracture was associated with a lower incidence of CRPS, but, not statistically significant.","['91 patients with unilateral extra-articular distal radius fractures', 'Ninety-one patients (ASA, n=44; PLA, n=47) were enrolled in the study', 'complex regional pain syndrome (CRPS) following a fracture of distal radius', 'patients with a distal radius fracture', 'patients recovering from distal radius fractures', 'patients who are recovered with surgery or injury', 'and complex regional pain syndrome after radius fractures']","['placebo (PLA) or 500 mg of aspirin (ASA', 'Aspirin', 'aspirin', 'CRPS', 'placebo']","['regional osteoporosis', 'prevalence of CRPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}]","[{'cui': 'C0559282', 'cui_str': 'Regional osteoporosis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}]",91.0,0.106391,"Administration of aspirin in patients with a distal radius fracture was associated with a lower incidence of CRPS, but, not statistically significant.","[{'ForeName': 'Amir Sobhani', 'Initials': 'AS', 'LastName': 'Eraghi', 'Affiliation': 'Department of Orthopaedics Surgery, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khazanchin', 'Affiliation': 'Bone and Joint Reconstruction Research Center, Shafa Orthopedic Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Department of Orthopaedics Surgery, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Pahlevansabagh', 'Affiliation': 'Department of Orthopaedics Surgery, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}]",European journal of translational myology,['10.4081/ejtm.2019.8643']
2918,32500194,CT fluoroscopy-guided transforaminal and intra-articular facet steroid injections for the treatment of cervical radiculopathy: injectate distribution patterns and association with clinical outcome.,"OBJECTIVES
To investigate injectate dispersal patterns and their association with therapeutic efficacy during a transforaminal (TFSI) or an intra-articular facet steroid injection (IFSI) to treat cervical radiculopathy.
METHODS
This retrospective study examined the post-intervention cervical spine CT of 56 patients randomized to receive one CT fluoroscopy-guided IFSI (29 patients; 10 (34.5%) males; mean age 45.0 years; SD 8.8 years; range 26-61 years) or TFSI (27 patients; 13 (48.2%) males; mean age 51.1 years; SD 11.2 years; range 29-72 years) (December 2010 to August 2013). The presence of contrast within the intra-articular facet, juxta-articular facet, retrodural, epidural, and foraminal and extraforaminal spaces during IFSI, and within the extraforaminal, foraminal, and epidural spaces during TFSI was assessed. Descriptive data are presented as frequencies. The association between injectate dispersal patterns and therapeutic efficacy, 4-week post-intervention, was assessed with ANCOVA models.
RESULTS
During IFSI, the injectate predominantly spread to the retrodural (62%; 18/29) or juxta-articular (21%; 6/29) space. During TFSI, the injectate predominantly spread to the extraforaminal/foraminal spaces (41%; 11/27) or to the extraforaminal/foraminal/epidural spaces (33%; 9/27). Injectate presence in the juxta-articular (p = .007) or extraforaminal (p < .001) space was a predictor of therapeutic efficacy but not in the foraminal (p = .54), epidural (p = .89), or retrodural (p = .75) space.
CONCLUSIONS
TFSI and IFSI led to preferential extraforaminal and retrodural injectate spread, respectively. Targeting the extraforaminal or juxta-articular facet space improved the clinical efficacy of steroid injections when treating cervical radiculopathy.
KEY POINTS
• During intra-articular facet injection, the injectate spreads from the facet joint to the retrodural space and rarely reaches the epidural and/or foraminal spaces. • Epidural spread of the injectate during an anterolateral transforaminal steroid injection is the least effective for pain relief in patients with cervical radiculopathy. • Injection techniques targeting the extraforaminal or juxta-articular facet space are safer than transforaminal injections and effectively relieve pain in patients with cervical radiculopathy.",2020,"Injectate presence in the juxta-articular (p = .007) or extraforaminal (p < .001) space was a predictor of therapeutic efficacy but not in the foraminal (p = .54), epidural (p = .89), or retrodural (p = .75) space.
","['56 patients randomized to receive one', 'patients with cervical radiculopathy', '29 patients; 10 (34.5%) males; mean age 45.0\xa0years; SD 8.8\xa0years; range 26-61\xa0years) or TFSI (27 patients; 13 (48.2%) males; mean age 51.1\xa0years; SD 11.2\xa0years; range 29-72\xa0years) (December 2010 to August 2013']","['transforaminal (TFSI) or an intra-articular facet steroid injection (IFSI', 'CT fluoroscopy-guided IFSI', 'transforaminal injections', 'steroid injections', 'CT fluoroscopy-guided transforaminal and intra-articular facet steroid injections']","['therapeutic efficacy', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742186', 'cui_str': 'Cervical radiculopathy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C4517531', 'cui_str': '11.2'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",56.0,0.0325887,"Injectate presence in the juxta-articular (p = .007) or extraforaminal (p < .001) space was a predictor of therapeutic efficacy but not in the foraminal (p = .54), epidural (p = .89), or retrodural (p = .75) space.
","[{'ForeName': 'Nathalie J', 'Initials': 'NJ', 'LastName': 'Bureau', 'Affiliation': ""Department of Radiology, Centre hospitalier de l'Université de Montréal (CHUM), 1000 rue Saint-Denis, Montreal, Quebec, H2X 0C1, Canada. nathalie.bureau@umontreal.ca.""}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Moser', 'Affiliation': ""Department of Radiology, Centre hospitalier de l'Université de Montréal (CHUM), 1000 rue Saint-Denis, Montreal, Quebec, H2X 0C1, Canada.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gouvion', 'Affiliation': ""Department of Radiology, Centre hospitalier de l'Université de Montréal (CHUM), 1000 rue Saint-Denis, Montreal, Quebec, H2X 0C1, Canada.""}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Julien', 'Affiliation': 'Department of Mathematics and Statistics, Université Laval, 1045 avenue de la Médecine, Québec, G1V 0A6, Canada.'}]",European radiology,['10.1007/s00330-020-06974-8']
2919,32500201,Efficacy of a novel urinary catheter for men with a local anesthetic injection port for catheter-related bladder discomfort: a randomized controlled study.,"PURPOSE
The NMOC-3WAY catheter ® is a novel urinary catheter for men that can be used to inject a local anesthetic into the urethra. We sought to assess whether the injection of a local anesthetic into the urethra via the NMOC-3WAY catheter ® would reduce catheter-related bladder discomfort (CRBD) after endovascular aneurysm repair (EVAR).
METHODS
Adult male patients who underwent elective EVAR for abdominal aortic aneurysms were randomly assigned to the 2% lidocaine group and the normal saline group (control group). CRBD was evaluated at 0, 1, 2, 4, and 6 h after surgery. The primary outcome was the incidence of CRBD at 0 h after surgery.
RESULTS
Data for 37 patients (19 in the lidocaine group and 18 in the control group) were analyzed. CRBD was observed at 0 h in six patients (31.6%; mild, n = 5; moderate, n = 1) in the lidocaine group and in five patients (27.8%; mild, n = 1; moderate, n = 3; severe, n = 1) in the control group. The control group showed a tendency to have severe CRBD at 0 h, although there was no significant difference in either the incidence (P = 0.80) or severity (P = 0.21) of CRBD between the two groups.
CONCLUSION
Our results suggest that the use of the NMOC-3WAY catheter ® for the injection of 2% lidocaine into the urethra does not reduce the incidence of CRBD immediately after EVAR. However, it may reduce moderate or severe CRBD that may lead to postoperative distress and agitation.",2020,"The control group showed a tendency to have severe CRBD at 0 h, although there was no significant difference in either the incidence (P = 0.80) or severity (P = 0.21) of CRBD between the two groups.
","['37 patients (19 in the', 'men with a local anesthetic injection port for catheter-related bladder discomfort', 'Adult male patients who underwent elective EVAR for abdominal aortic aneurysms']","['novel urinary catheter', 'normal saline group (control group', 'lidocaine']","['CRBD', 'catheter-related bladder discomfort (CRBD', 'incidence of CRBD at 0\xa0h after surgery', 'severe CRBD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",37.0,0.0766028,"The control group showed a tendency to have severe CRBD at 0 h, although there was no significant difference in either the incidence (P = 0.80) or severity (P = 0.21) of CRBD between the two groups.
","[{'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Imai', 'Affiliation': 'Department of Anesthesiology, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, 951-8510, Japan. hdkzimi@med.niigata-u.ac.jp.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Department of Anesthesiology, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, 951-8510, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Anesthesiology, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, 951-8510, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02807-6']
2920,32500209,Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials.,"RATIONALE
Posttraumatic stress disorder (PTSD) is a chronic condition that has wide-ranging negative effects on an individual's health and interpersonal relationships. Treatments with long-term benefits are needed to promote the safety and well-being of those suffering from PTSD.
OBJECTIVES
To examine long-term change in PTSD symptoms and additional benefits/harms after 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD.
METHODS
Participants received two to three active doses of MDMA (75-125 mg) during blinded or open-label psychotherapy sessions with additional non-drug therapy sessions. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) at baseline, 1 to 2 months after the last active MDMA session (treatment exit), and at least 12 months post final MDMA session (LTFU). A mixed-effect repeated-measures (MMRM) analysis assessed changes in CAPS-IV total severity scores. The number of participants who met PTSD diagnostic criteria was summarized at each time point. Participants completed a long-term follow-up questionnaire.
RESULTS
There was a significant reduction in CAPS-IV total severity scores from baseline to treatment exit (LS mean (SE) = - 44.8 (2.82), p < .0001), with a Cohen's d effect size of 1.58 (95% CI = 1.24, 1.91). CAPS-IV scores continued to decrease from treatment exit to LTFU (LS mean (SE) = - 5.2 (2.29), p < .05), with a Cohen's d effect size of 0.23 (95% CI = 0.04, 0.43). The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%). The majority of participants reported benefits, including improved relationships and well-being, and a minority reported harms from study participation.
CONCLUSIONS
PTSD symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and symptom improvement continued at least 12 months post-treatment. Phase 3 trials are investigating this novel treatment approach in a larger sample of participants with chronic PTSD.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.",2020,The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%).,"['participants with chronic PTSD', 'PTSD', 'Participants', 'Posttraumatic stress disorder (PTSD']","['open-label psychotherapy sessions with additional non-drug therapy sessions', '3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy', 'MDMA', 'MDMA-assisted psychotherapy']","['CAPS-IV scores', 'PTSD symptoms', 'CAPS-IV total severity scores', 'Clinician-Administered PTSD Scale for DSM IV']","[{'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",,0.111743,The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%).,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jerome', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA. Ilsa@mapsbcorp.com.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Feduccia', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.'}, {'ForeName': 'Julie B', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Stanford School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Berra', 'Initials': 'B', 'LastName': 'Yazar-Klosinski', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Emerson', 'Affiliation': 'MAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Mithoefer', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Doblin', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05548-2']
2921,32500212,Subjective features of the psilocybin experience that may account for its self-administration by humans: a double-blind comparison of psilocybin and dextromethorphan.,"RATIONALE
Although both psilocybin and dextromethorphan (DXM) produce psychedelic-like subjective effects, rates of non-medical use of psilocybin are consistently greater than DXM.
OBJECTIVE
New data are presented from a study of psilocybin and DXM relevant to understanding the features of psilocybin subjective effects that may account for its higher rates of non-medical use.
METHODS
Single, acute oral doses of psilocybin (10, 20, 30 mg/70 kg), DXM (400 mg/70 kg), and placebo were administered under double-blind conditions to 20 healthy participants with histories of hallucinogen use.
RESULTS
High doses of both drugs produced similar time courses and increases in participant ratings of peak overall drug effect strength. Nine subjective effect domains are proposed to be related to the reinforcing effects of psilocybin: liking, visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience. For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM. These differences were consistent with two measures of desire to take the drug condition again.
CONCLUSIONS
This analysis provides new information about domains of psilocybin subjective effects proposed to be related to its reinforcing effects (alternatively described as the ""motivation"" to use). Observed differences on these domains between psilocybin and DXM are consistent with the relative rates of non-medical use of psilocybin and DXM.",2020,"For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM.",['20 healthy participants with histories of hallucinogen use'],"['psilocybin and dextromethorphan', 'psilocybin and dextromethorphan (DXM', 'psilocybin', 'DXM', 'placebo']","['visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience', 'participant ratings of peak overall drug effect strength', 'DXM']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004898', 'cui_str': 'Beauty'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}]",20.0,0.150916,"For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM.","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Carbonaro', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA. rgriff@jhmi.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05533-9']
2922,32500675,Patient-controlled subcutaneous analgesia using sufentainil or morphine in home care treatment in patients with stage III-IV cancer: A multi-center randomized controlled clinical trial.,"PURPOSE
Patient-controlled subcutaneous analgesia (PCSA) with sufentanil is an alternative analgesia strategy in patients with stage III-IV cancer; however, its efficacy and safety have not been fully investigated.
METHODS
From May 10, 2017 to November 10, 2017, 120 patients with stage III-IV cancer suffering from moderate to severe pain were prospectively enrolled from six hospitals and randomized to receive PCSA with morphine (control group) or sufentanil (intervention group). Before the PCSA and on days 1, 3, 7, 14, 28, and 56 after treatment, the numeric rating scale (NRS) and 36-item Short Form health survey (SF-36) were completed for each patient and the side effects were also recorded.
RESULTS
No significant differences (P > .05) were observed in the preoperative NRS score and the SF-36 parameters between the two groups. Patients in the intervention group achieved better pain relief, as indicated by lower NRS scores at days 14 (P = .040), 28 (P < .001), and 56 (P < .001) after PCSA device implantation (vs control group). Furthermore, the patients in the intervention group also achieved a better life quality, as indicated by the physical role, general health, social function body pain, and mental health scores. Finally, the patients receiving sufentanil showed lower levels of nausea and somnolence than those in the control group.
CONCLUSION
PCSA with sufentanil achieves better pain control and life quality as well as fewer adverse reactions in stage III-IV cancer patients with pain and may be a promising pain management in these patients.
TRIAL REGISTRATION
This study was registered at chictr.org.cn with the trial number: ChiCTR-IPR-17011280.",2020,No significant differences (P > .05) were observed in the preoperative NRS score and the SF-36 parameters between the two groups.,"['From May 10, 2017 to November 10, 2017, 120 patients with stage III-IV cancer suffering from moderate to severe pain', 'stage III-IV cancer patients with pain', 'patients with stage III-IV cancer']","['PCSA with sufentanil', 'sufentanil', 'sufentainil or morphine', 'PCSA with morphine (control group) or sufentanil']","['nausea and somnolence', 'preoperative NRS score and the SF-36 parameters', 'pain relief', 'numeric rating scale (NRS) and 36-item Short Form health survey (SF-36', 'physical role, general health, social function body pain, and mental health scores', 'adverse reactions', 'life quality', 'pain control and life quality', 'lower NRS scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",120.0,0.118879,No significant differences (P > .05) were observed in the preoperative NRS score and the SF-36 parameters between the two groups.,"[{'ForeName': 'Cheng-Fu', 'Initials': 'CF', 'LastName': 'Wan', 'Affiliation': 'Pain Department of the First Affiliated Hospital, China Medical University, Shenyang, China.'}, {'ForeName': 'Qing-Zhu', 'Initials': 'QZ', 'LastName': 'Meng', 'Affiliation': 'Pain Department of the Central Hospital of Haicheng city, Anshan, China.'}, {'ForeName': 'Yan-Wei', 'Initials': 'YW', 'LastName': 'Wang', 'Affiliation': ""Pain Department of the Third People's Hospital of Anshan city, Anshan, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Pain Department of the Central Hospital of Fuxin city, Fuxin, China.'}, {'ForeName': 'Chang-Liang', 'Initials': 'CL', 'LastName': 'Ai', 'Affiliation': ""Pain Department of the Women and Children's Hospital of Dandong city, Dandong, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': 'Pain Department of the Central Hospital of Kuandian city, Dandong, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Pain Department of the First Affiliated Hospital, China Medical University, Shenyang, China.'}]",Cancer medicine,['10.1002/cam4.3194']
2923,32500717,Impact of Acamprosate on Chronic Tinnitus: A Randomized-Controlled Trial.,"OBJECTIVES
Tinnitus is a common and distressing otologic symptom, with various probable pathophysiologic mechanisms, such as an imbalance between excitatory and inhibitory mechanisms. Acamprosate, generally used to treat alcoholism, is a glutaminergic antagonist and GABA agonist suggested for treating tinnitus. Thus, we aimed to evaluate the efficacy and safety of acamprosate in the treatment of tinnitus.
METHODS
The current randomized-controlled trial study included 20 subjects with chronic tinnitus. After performing psycho-acoustic, psychometric and electrophysiological evaluations, all studied tinnitus subjects were randomly divided into two groups of acamprosate and placebo. The first group received oral acamprosate (two tablets of 333 mg/d, three times a day), whereas the second group was given placebo treatment (two tablets, three times a day). After the first 30 days, all evaluations were repeated for the studied groups just in the same manner before the study. Subsequently, the final results of each evaluation were compared together with the baseline values.
RESULTS
Nine studied subjects randomly received acamprosate, whereas eleven others received a placebo. There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus ( P = .039). For those subjects who were receiving acamprosate, a significant reduction was observed in tinnitus handicap inventory ( P = .006), tinnitus questionnaire scores ( P = .007), and the visual analog scores ( P = .007) compared to the placebo group. There was a significant reduction in Action Potential latency ( P = .048) as well as an increase in the amplitude of distortion product otoacoustic emissions at 4 kHz ( P = .048).
CONCLUSIONS
The study results indicated a subjective relief of tinnitus as well as some degree of the electrophysiological improvement at the level of the cochlear and the distal portion of the auditory nerve among the subjects who received the acamprosate.
CLINICAL TRIAL REGISTRATION CODE
IRCT2013121115751N1.",2020,"There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus ( P = .039).","['20 subjects with chronic tinnitus', 'Chronic Tinnitus']","['Acamprosate', 'oral acamprosate', 'acamprosate and placebo', 'acamprosate', 'placebo']","['pitch match of tinnitus', 'Action Potential latency', 'tinnitus questionnaire scores', 'amplitude of distortion product otoacoustic emissions', 'subjective relief of tinnitus', 'psycho-acoustic tests', 'efficacy and safety', 'tinnitus handicap inventory', 'visual analog scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]","[{'cui': 'C0284941', 'cui_str': 'acamprosate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0162525', 'cui_str': 'Spontaneous Otoacoustic Emissions'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",20.0,0.0489289,"There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus ( P = .039).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Farhadi', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Salem', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alimohamad', 'Initials': 'A', 'LastName': 'Asghari', 'Affiliation': 'Skull Base Research Center, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Daneshi', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mirsalehi', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Mahmoudian', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420930773']
2924,32500725,Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies.,"BACKGROUND
Switching between antiarrhythmic drugs is timed to minimize arrhythmia recurrence and adverse reactions. Dronedarone and amiodarone have similar electrophysiological profiles; however, little is known about the optimal timing of switching, given the long half-life of amiodarone.
METHODS
The ARTEMIS atrial fibrillation (AF) Loading and Long-term studies evaluated switching patients with paroxysmal/persistent AF from amiodarone to dronedarone. Patients were randomized based on the timing of the switch: immediate, after a 2-week, or after a 4-week washout of amiodarone. Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion. The primary objectives were, for the Loading study, to evaluate recurrence of AF ≤60 days; and for the Long-term study, to profile the pharmacokinetics of dronedarone and its metabolite according to different timings of dronedarone initiation.
RESULTS
In ARTEMIS AF Loading, 176 were randomized (planned 768) after a 28 ± 2 days load of oral amiodarone. Atrial fibrillation recurrence trended less in the immediate switch versus 4-week washout group (hazard ratio [HR] = 0.65 [97.5% CI: 0.34-1.23]; P = .14) and in the 2-week washout versus the 4-week washout group (HR = 0.75 [97.5% CI: 0.41-1.37]; P = .32). In ARTEMIS AF Long-term, 108 patients were randomized (planned 105). Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
CONCLUSION
The trial was terminated early due to poor recruitment and so our findings are limited by low numbers. However, immediate switching from amiodarone to dronedarone appeared to be well tolerated and safe.",2020,"Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
","['108 patients were randomized (planned 105', 'Patients With Atrial Fibrillation', 'Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion', 'patients with paroxysmal/persistent AF from']","['dronedarone', 'amiodarone to dronedarone', 'amiodarone', 'Dronedarone', 'Amiodarone']","['Atrial fibrillation recurrence', 'tolerated and safe']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",108.0,0.0279373,"Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
","[{'ForeName': 'Gerald V', 'Initials': 'GV', 'LastName': 'Naccarelli', 'Affiliation': 'Division of Cardiology, Heart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group Molecular & Clinical Sciences Institute, St George's University of London, London, UK.""}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Le Heuzey', 'Affiliation': 'Hôpital Européen Georges Pompidou, Université Paris V René Descartes, Paris, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Lombardi', 'Affiliation': 'Cardiologia, Fondazione IRCCS Ospedale Maggiore Policlinico, Milan, Italy.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Tamargo', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Medicine, CIBERCV, University Complutense, Madrid, Spain.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Martinez', 'Affiliation': 'Sanofi, Montpellier, France.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Naditch-Brûlé', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420926874']
2925,32500733,Ambient Scent as a Positive Distraction in Long-Term Care Units: Theory of Supportive Design.,"AIM
This study was designed to explore the associations between an ambient scent environment and residents' wellness in long-term care facilities.
BACKGROUND
The number of older adults living in an institutional setting has been steadily but slowly increasing. Because of a higher chance of having psychological disorders among people living in institutional settings than people living in noninstitutional settings, providing a supportive institutional setting is critical to enhance their wellness. The theory of supportive design suggests healthcare facilities can lower people's stress levels via three conditions (i.e., perceived control, social support, and positive distractions).
METHOD
A single-blind and placebo-randomized controlled study investigated the impacts of ambient scent environment, as a positive distraction, on residents' depression levels. The recruited residents ( N = 58) were randomly assigned into either the intervention group, which received a 1% dilution of lavender scent for 2 weeks nearby their bedside or the placebo group, which received a nonscent for 2 weeks.
RESULTS
Their depression levels were measured by the Geriatric Depression Scale. Based on the t tests, both intervention and placebo groups had improvement in depression, indicating a placebo effect of lavender scent. Further regression analyses explored the interaction effects of built environments (e.g., building, distance to a ventilation system, and square footage). However, no statistically significant impact of the built environment was found.
CONCLUSION
Despite a placebo effect of ambient scent environment and nonsignificant built environment on depression, this study has valuable implications of being a positive distraction during the healing process as developed by the Theory of Supportive design.",2020,"Based on the t tests, both intervention and placebo groups had improvement in depression, indicating a placebo effect of lavender scent.",['recruited residents ( N = 58'],"['1% dilution of lavender scent for 2 weeks nearby their bedside or the placebo', 'placebo']","['depression levels', 'depression', 'Geriatric Depression Scale']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0031516', 'cui_str': 'Recognition odor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",58.0,0.119674,"Based on the t tests, both intervention and placebo groups had improvement in depression, indicating a placebo effect of lavender scent.","[{'ForeName': 'Suyeon', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Department of Architectural Studies, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Abimbola O', 'Initials': 'AO', 'LastName': 'Asojo', 'Affiliation': 'Interior Design, Department of Design, Housing, and Apparel, University of Minnesota, St. Paul, MN, USA.'}]",HERD,['10.1177/1937586720929021']
2926,32500740,I Feel Better Naked: Communal Naked Activity Increases Body Appreciation by Reducing Social Physique Anxiety.,"Positive body image predicts several measures of happiness, well-being, and sexual functioning. Prior research has suggested a link between communal naked activity and positive body image, but has thus far not clarified either the direction or mechanisms of this relationship. This was the first randomized controlled trial of the effects of nakedness on body image. Two potential explanatory mediators of this effect were also investigated. Fifty-one participants were randomly assigned to one of two groups in which they interacted with other people either naked (naked condition) or clothed (control condition). All participants completed measures of body appreciation before and after the intervention, as well as measures of the relative perceived attractiveness of others and social physique anxiety immediately after the intervention. Perceived attractiveness of others was neither affected by the manipulation nor correlated with body appreciation. However, as expected, participants in the naked condition reported more body appreciation, an effect that was mediated by reductions in social physique anxiety. This research provides initial evidence that naked activity can lead to improvements in body image and evidence of a specific explanatory mechanism. Theoretical and practical implications are discussed.",2020,This research provides initial evidence that naked activity can lead to improvements in body image and evidence of a specific explanatory mechanism.,['Fifty-one participants'],['people either naked (naked condition) or clothed (control condition'],"['happiness, well-being, and sexual functioning', 'social physique anxiety', 'body appreciation', 'relative perceived attractiveness of others and social physique anxiety']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424470', 'cui_str': 'Undressed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0424611', 'cui_str': 'Physique type'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",51.0,0.0373859,This research provides initial evidence that naked activity can lead to improvements in body image and evidence of a specific explanatory mechanism.,"[{'ForeName': 'Keon', 'Initials': 'K', 'LastName': 'West', 'Affiliation': 'Department of Psychology, Goldsmiths, University of London.'}]",Journal of sex research,['10.1080/00224499.2020.1764470']
2927,32450904,Comparison of blogshots with plain language summaries of Cochrane systematic reviews: a qualitative study and randomized trial.,"BACKGROUND
Cochrane, an organization dedicated to the production and dissemination of high-quality evidence on health, endeavors to reach consumers by developing appropriate summary formats of its systematic reviews. However, the optimal type of presentation of evidence to consumers is still unknown.
OBJECTIVE
The aim of this study was to investigate consumer preferences for different summary formats of Cochrane systematic reviews (CSRs), using both qualitative and quantitative approaches.
METHODS
Initially, we conducted three focus groups with medical students (n = 7), doctors (n = 4), and patients (n = 9) in 2017 to explore their health information search habits and preferences for CSR summary formats. Based on those findings, we conducted a randomized trial with medical students at the University of Split School of Medicine, Croatia, and with patients from three Dalmatian family practices to determine whether they prefer CSR blogshots (n = 115) or CSR plain language summaries (PLSs; n = 123).
RESULTS
Participants in the focus groups favored brief and explicit CSR summary formats with fewer numbers. Although we found no difference in participants' preferences for a specific summary format in the overall sample, subgroup analysis showed that patients preferred blogshots over PLSs in comparison to medical students (P = 0.003, eta squared effect size η 2 = 0.04).
CONCLUSION
CSR summaries should be produced in a format that meets the expectations and needs of consumers. Use of blogshots as a summary format could enhance the dissemination of CSRs among patients.
TRIAL REGISTRATION
The trial was registered in ClinicalTrials.gov, NCT03542201. Registered on May 31st 2018.",2020,"Although we found no difference in participants' preferences for a specific summary format in the overall sample, subgroup analysis showed that patients preferred blogshots over PLSs in comparison to medical students (P = 0.003, eta squared effect size η 2 = 0.04).
","['medical students at the University of Split School of Medicine, Croatia, and with patients from three Dalmatian family practices to determine whether they prefer CSR blogshots (n\u2009=\u2009115) or CSR plain language summaries (PLSs; n\u2009=\u2009123', 'groups with medical students (n\u2009=\u20097), doctors (n\u2009=\u20094), and patients (n\u2009=\u20099) in 2017 to explore their health information search habits and preferences for CSR summary formats']",[],[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0324355', 'cui_str': 'Dalmatian dog'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1301627', 'cui_str': 'Format'}]",[],[],,0.172296,"Although we found no difference in participants' preferences for a specific summary format in the overall sample, subgroup analysis showed that patients preferred blogshots over PLSs in comparison to medical students (P = 0.003, eta squared effect size η 2 = 0.04).
","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Buljan', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia. ivan.buljan@mefst.hr.'}, {'ForeName': 'Ružica', 'Initials': 'R', 'LastName': 'Tokalić', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Roguljić', 'Affiliation': 'Department of Oral Diseases and Periodontology, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Zakarija-Grković', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Davorka', 'Initials': 'D', 'LastName': 'Vrdoljak', 'Affiliation': 'Department of Family Medicine, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Milić', 'Affiliation': 'University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Puljak', 'Affiliation': 'Center for Evidence-based Medicine and Health Care, Catholic University of Croatia, Split, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Marušić', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}]",Trials,['10.1186/s13063-020-04360-9']
2928,32450908,Efficacy and safety of Bujing Yishi tablet for glaucoma with controlled IOP: study protocol for a multi-centre randomized controlled trial.,"BACKGROUND
As an irreversible, intractable disease with vision loss, glaucoma leads to permanent and progressive damage of visual function. Lowering high intraocular pressure (HIOP) is the first choice for treating glaucoma; however, the control of HIOP is not enough to prevent progressive vison loss. Currently, the therapies to treat glaucoma with controlled IOP (GPCI) are unsatisfactory. Chinese medicine is effective for improving visual function in patients with GPCI. Bujing Yishi tablets (BJYSP) have been the standard preparation for treating GPCI in our hospital for decades. However, no rigorous randomized controlled clinical studies have investigated its effects and safety.
METHODS
This study will be a 6-month, multicenter, stratified trial following a prospective, randomized, open-label, blinded endpoint (PROBE) protocol. A total of 216 eligible GPCI patients aged 18-75 years will be stratified according to the early, moderate, and advanced stages of glaucoma. After stratifying, the participants will be randomly assigned to the BJYSP group or control group at a ratio of 1:1. Following randomization, participants in the BJYSP group and control group will receive BJYSP and mecobalamin tablets, respectively, for the same 6-month period. The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales. The primary and secondary outcomes will be measured at baseline and 8, 16, and 24 weeks thereafter. Safety assessments will also be evaluated at baseline and 12 and 24 weeks thereafter.
DISCUSSION
This study will be a standardized, scientific, clinical trial designed to evaluate the therapeutic effects and safety of BJYSP as a novel therapeutic strategy for improving visual function in patients with GPCI.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR1800016431. Registered on 1 June 2018.",2020,"The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales.","['patients with GPCI', '216 eligible GPCI patients aged 18-75\u2009years will be stratified according to the early, moderate, and advanced stages of glaucoma']","['BJYSP', 'Lowering high intraocular pressure (HIOP', 'Bujing Yishi tablets (BJYSP', 'BJYSP and mecobalamin tablets', 'Bujing Yishi tablet', 'Chinese medicine']","['visual function', 'best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015217', 'cui_str': 'Visual evoked potential'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",216.0,0.291797,"The primary outcomes will include the best-corrected visual acuity (BCVA), visual field assessment, visual evoked potential (VEP) test, and Heidelberg retina tomography II (HRT II); the secondary outcomes will include intraocular pressure (IOP) and Traditional Chinese medicine (TCM) clinical symptom scales.","[{'ForeName': 'Hongji', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Mianyang Central Hospital, Mianyang, 621000, Sichuan, China. carol_hongji@126.com.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China. jeannelxiang@cdutcm.edu.cn.'}, {'ForeName': 'Zongduan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, The Affiliated Eye Hospital of Wenzhou Medical University, Wenzhou, 325027, Zhejiang, China.'}, {'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'National Drug Clinical Trial Agency, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Ophthalmology, Mianyang Central Hospital, Mianyang, 621000, Sichuan, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Mianyang Hospital of Traditional Chinese Medicine, Mianyang, 621000, Sichuan, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Chengdu PiDu District, Chengdu, 611733, Sichuan, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510275, Guangdong, China.'}, {'ForeName': 'Linru', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Ophthalmology, Mianyang Central Hospital, Mianyang, 621000, Sichuan, China.'}]",Trials,['10.1186/s13063-020-04249-7']
2929,32450914,"Update to the AWED (Applying Wolbachia to Eliminate Dengue) trial study protocol: a cluster randomised controlled trial in Yogyakarta, Indonesia.","BACKGROUND
The AWED (Applying Wolbachia to Eliminate Dengue) trial is a parallel, two-arm, non-blinded cluster randomised controlled trial that is under way in Yogyakarta, Indonesia, with the aim of measuring the efficacy of Wolbachia-infected Aedes aegypti deployments in reducing dengue incidence in an endemic setting. Enrolment began in January 2018 and is ongoing. The original study protocol was published in April 2018. Here, we describe amendments that have been made to the study protocol since commencement of the trial.
METHODS
The key protocol amendments are (1) a revised study duration with planned end of participant enrolment in August 2020, (2) the addition of new secondary objectives (i) to estimate serotype-specific efficacy of the Wolbachia intervention and (ii) to compare Ae. aegypti abundance in intervention versus untreated clusters, (3) an additional exposure classification for the per-protocol analysis where the Wolbachia exposure index is calculated using only the cluster-level Wolbachia prevalence in the participant's cluster of residence, (4) power re-estimation using a multinomial sampling method that better accounts for randomness in sampling, and (5) the addition of two trial stopping rules to address the potential for persistently low rates of virologically confirmed dengue case enrolment and Wolbachia contamination into untreated clusters. Additional minor changes to the protocol are also described.
DISCUSSION
The findings from this study will provide the first experimental evidence for the efficacy of Wolbachia in reducing dengue incidence. Enrolment in the trial will conclude this year (2020) and results will be reported shortly thereafter.
TRIAL REGISTRATION
ClinicalTrials.gov, identifier: NCT03055585. Registered on 14 February 2017. Last updated 22 March 2020.",2020,"BACKGROUND
The AWED (Applying Wolbachia to Eliminate Dengue)",[],"['Wolbachia intervention and (ii) to compare Ae', 'Wolbachia-infected Aedes aegypti deployments']",['aegypti abundance'],[],"[{'cui': 'C0752001', 'cui_str': 'Wolbachia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}]",[],,0.212877,"BACKGROUND
The AWED (Applying Wolbachia to Eliminate Dengue)","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Anders', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia. katie.anders@worldmosquito.org.'}, {'ForeName': 'Citra', 'Initials': 'C', 'LastName': 'Indriani', 'Affiliation': 'Department of Biostatistics, Epidemiology and Population Health and Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Riris Andono', 'Initials': 'RA', 'LastName': 'Ahmad', 'Affiliation': 'Department of Biostatistics, Epidemiology and Population Health and Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Warsito', 'Initials': 'W', 'LastName': 'Tantowijoyo', 'Affiliation': 'World Mosquito Program, Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Eggi', 'Initials': 'E', 'LastName': 'Arguni', 'Affiliation': 'Department of Pediatrics and Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Bekti', 'Initials': 'B', 'LastName': 'Andari', 'Affiliation': 'Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Jewell', 'Affiliation': 'Centre for Statistical Methodology, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Dufault', 'Affiliation': 'School of Public Health, University of California, 2121 Berkeley Way, Berkeley, 94720-7360, CA, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ryan', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Tanamas', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Edwige', 'Initials': 'E', 'LastName': 'Rancès', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': ""O'Neill"", 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Cameron P', 'Initials': 'CP', 'LastName': 'Simmons', 'Affiliation': 'Institute of Vector Borne Disease, Monash University, 12 Innovation Walk, Melbourne, 3800, Victoria, Australia.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Utarini', 'Affiliation': 'Department of Health Policy and Management, and Centre for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Jl. Medika, Yogyakarta, 55281, Indonesia.'}]",Trials,['10.1186/s13063-020-04367-2']
2930,32450915,"The COVIRL-001 Trial: A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline: A structured summary of a study protocol for a randomised controlled trial.",,2020,,"['non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline']","['hydroxychloroquine and azithromycin', 'care (SOC) alone, SOC plus hydroxychloroquine monotherapy']",[],"[{'cui': 'C3888499', 'cui_str': 'Polymerase chain reaction positive'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.338873,,"[{'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Feeney', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland. deborah.wallace@ucd.ie.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Cotter', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Willard', 'Initials': 'W', 'LastName': 'Tinago', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'McCarthy', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Keane', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Hussain', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Alvarez Barco', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mallon', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}]",Trials,['10.1186/s13063-020-04407-x']
2931,32450917,"Study Protocol for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a pragmatic, registry-based, multi-center, double-blind, randomized controlled trial evaluating the effect of intravenous fluid therapy with Plasma-Lyte 148 versus 0.9% saline on delayed graft function in deceased donor kidney transplantation.","BACKGROUND
Delayed graft function, the requirement for dialysis due to poor kidney function post-transplant, is a frequent complication of deceased donor kidney transplantation and is associated with inferior outcomes and higher costs. Intravenous fluids given during and after transplantation may affect the risk of poor kidney function after transplant. The most commonly used fluid, isotonic sodium chloride (0.9% saline), contains a high chloride concentration, which may be associated with acute kidney injury, and could increase the risk of delayed graft function. Whether using a balanced, low-chloride fluid instead of 0.9% saline is safe and improves kidney function after deceased donor kidney transplantation is unknown.
METHODS
BEST-Fluids is an investigator-initiated, pragmatic, registry-based, multi-center, double-blind, randomized controlled trial. The primary objective is to compare the effect of intravenous Plasma-Lyte 148 (Plasmalyte), a balanced, low-chloride solution, with the effect of 0.9% saline on the incidence of delayed graft function in deceased donor kidney transplant recipients. From January 2018 onwards, 800 participants admitted for deceased donor kidney transplantation will be recruited over 3 years in Australia and New Zealand. Participants are randomized 1:1 to either intravenous Plasmalyte or 0.9% saline peri-operatively and until 48 h post-transplant, or until fluid is no longer required; whichever comes first. Follow up is for 1 year. The primary outcome is the incidence of delayed graft function, defined as dialysis in the first 7 days post-transplant. Secondary outcomes include early kidney transplant function (composite of dialysis duration and rate of improvement in graft function when dialysis is not required), hyperkalemia, mortality, graft survival, graft function, quality of life, healthcare resource use, and cost-effectiveness. Participants are enrolled, randomized, and followed up using the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry.
DISCUSSION
If using Plasmalyte instead of 0.9% saline is effective at reducing delayed graft function and improves other clinical outcomes in deceased donor kidney transplantation, this simple, inexpensive change to using a balanced low-chloride intravenous fluid at the time of transplantation could be easily implemented in the vast majority of transplant settings worldwide.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry: ACTRN12617000358347. Registered on 8 March 2017. ClinicalTrials.gov: NCT03829488. Registered on 4 February 2019.",2020,"If using Plasmalyte instead of 0.9% saline is effective at reducing delayed graft function and improves other clinical outcomes in deceased donor kidney transplantation, this simple, inexpensive change to using a balanced low-chloride intravenous fluid at the time of transplantation could be easily implemented in the vast majority of transplant settings worldwide.
","['deceased donor\xa0kidney transplant recipients', '800 participants admitted for deceased donor kidney transplantation will be recruited over 3 years in Australia and New Zealand', 'deceased donor kidney transplantation', 'Australian New Zealand Clinical Trials Registry']","['intravenous Plasmalyte or 0.9% saline peri-operatively and until 48\u2009h post-transplant', 'isotonic sodium chloride (0.9% saline', 'intravenous Plasma-Lyte 148 (Plasmalyte', 'intravenous fluid therapy with Plasma-Lyte 148 versus 0.9% saline']","['early kidney transplant function (composite of dialysis duration and rate of improvement in graft function when dialysis is not required), hyperkalemia, mortality, graft survival, graft function, quality of life, healthcare resource use, and cost-effectiveness', 'delayed graft function', 'incidence of delayed graft function, defined as dialysis in the first 7 days post-transplant', 'kidney function', 'risk of poor kidney function']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0071208', 'cui_str': 'Plasma-lyte 148'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",800.0,0.626492,"If using Plasmalyte instead of 0.9% saline is effective at reducing delayed graft function and improves other clinical outcomes in deceased donor kidney transplantation, this simple, inexpensive change to using a balanced low-chloride intravenous fluid at the time of transplantation could be easily implemented in the vast majority of transplant settings worldwide.
","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Collins', 'Affiliation': 'Department of Renal Medicine, Auckland District Health Board, Auckland City Hospital, Auckland, New Zealand. michael.collins@adhb.govt.nz.'}, {'ForeName': 'Magid A', 'Initials': 'MA', 'LastName': 'Fahim', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Dansie', 'Affiliation': 'Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Clayton', 'Affiliation': 'Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Rachael C', 'Initials': 'RC', 'LastName': 'McConnochie', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Mount', 'Affiliation': 'Department of Nephrology, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Varghese', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Liza A', 'Initials': 'LA', 'LastName': 'Vergara', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Weinberg', 'Affiliation': 'Department of Anaesthesia, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Chadban', 'Affiliation': 'Department of Renal Medicine, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04359-2']
2932,32459394,Parent reports of sun safety communication and behaviour for students in a randomised trial on a school policy implementation intervention.,"OBJECTIVE
Schools are an important setting for skin cancer prevention. An intervention for implementation of school sun safety policy, Sun Safety Schools (SSS), was evaluated.
METHODS
Primary schools (n=118) in California school districts that had already adopted a sun safety policy were enrolled in a study with a randomised controlled design. Half of the schools were randomised to SSS intervention (N=58). Parents completed an online post-test.
RESULTS
More parents in intervention schools received information about sun safety (mean=26.3%, sd=3.1%, p=0.017) and children more frequently wore sun-protective clothing when not at school (mean=2.93, sd=0.03, p=0.033) than in control schools (mean=18.0%, sd=2.5%; mean=2.83, sd=0.03, respectively). In schools where principals reported implementing sun safety practices, parents reported that children spent less time outdoors at midday (mean=14.78 hours, sd=0.25, p=0.033) and fewer were sunburned (mean=12.7%, sd=1.1%, p=0.009) than in non-implementing schools (M=16.3 hours, sd=0.67; mean=21.2%, sd=3.8%, respectively). Parents who received sun safety information (mean=3.08, sd=0.04, p=0.008) reported more child sun protection than parents not receiving information (mean=2.96, sd=0.02).
CONCLUSIONS
A school district sun protection policy and support for implementation increased dissemination of sun safety information to parents and student sun safety. Implications for public health: Technical assistance for sun safety policies may increase sun protection of children.",2020,"More parents in intervention schools received information about sun safety (mean=26.3%, sd=3.1%, p=0.017) and children more frequently wore sun-protective clothing when not at school (mean=2.93, sd=0.03, p=0.033) than in control schools (mean=18.0%, sd=2.5%; mean=2.83, sd=0.03, respectively).","['Primary schools (n=118) in California school districts that had already adopted a sun safety policy', 'public health', 'children']","['SSS intervention', 'sun safety information']","['children spent less time outdoors at midday', 'information about sun safety', 'child sun protection']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0585020', 'cui_str': 'Noon'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.152215,"More parents in intervention schools received information about sun safety (mean=26.3%, sd=3.1%, p=0.017) and children more frequently wore sun-protective clothing when not at school (mean=2.93, sd=0.03, p=0.033) than in control schools (mean=18.0%, sd=2.5%; mean=2.83, sd=0.03, respectively).","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel Inc., Colorado, US.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Reynolds', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, California, US.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel Inc., Colorado, US.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Massie', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, California, US.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Klein Buendel Inc., Colorado, US.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Ashley', 'Affiliation': 'Sun Safety for Kids, California, US.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Center for Health Research, Oregon, US.'}]",Australian and New Zealand journal of public health,['10.1111/1753-6405.12987']
2933,32454161,Acute methylphenidate administration reduces cocaine-cue attentional bias.,"Mechanistic research on behavioral processes underlying substance use disorder might help identify novel targets for interventions development. Drug-related attentional bias and response inhibition deficits have received a great deal of consideration in substance use research, broadly, and cocaine use research, specifically. Studies investigating pharmacological mechanisms that may ameliorate, or further impair, these behaviors relevant to cocaine use are relatively lacking. This study evaluated the impact of acute administration of methylphenidate, a dopamine-favoring reuptake inhibitor, on both gaze-related cocaine-cue-attentional bias and cocaine-cue related disruptions in response inhibition among individuals with cocaine use disorder. Participants (N = 12; 33% female) completed a within-subject, outpatient, acute dosing study. Two sessions were completed in which methylphenidate (60 mg) or placebo were administered followed by completion of an attentional bias task using eye-tracking technology and neutral-cue and cocaine-cue response inhibition tasks. Subjective and physiological effects were also recorded. Significant cocaine cue attentional bias and response inhibition failures were observed during placebo administration. Acute methylphenidate administration reduced cocaine-cue attentional bias as measured by cocaine-cue gaze fixations (d z = 1.04; Bayes Factor = 12.37). No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04). Methylphenidate produced prototypical subjective and physiological effects. Although the small sample should be considered, these findings indicate acute manipulation of dopaminergic activity reduced cue-related attentional allocation related to cocaine use disorder. Future research evaluating alternative dopaminergic agents and applications within a clinical setting are needed to determine the clinical significance of targeting this neurobehavioral mechanism.",2020,No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04).,"['individuals with cocaine use disorder', 'Participants (N\u202f=\u202f12; 33% female) completed a within-subject, outpatient, acute dosing study']","['cocaine-cue gaze fixations ', 'attentional bias task using eye-tracking technology and neutral-cue and cocaine-cue response inhibition tasks', 'methylphenidate', 'Methylphenidate', 'Acute methylphenidate', 'placebo']","['prototypical subjective and physiological effects', 'response inhibition', 'cocaine-cue attentional bias', 'Subjective and physiological effects', 'Significant cocaine cue attentional bias and response inhibition failures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",2.0,0.0536529,No statistically significant effects of methylphenidate were observed on response inhibition (Bayes Factors = 0.17-1.04).,"[{'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Alcorn', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Lile', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1110 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536-0086, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY 40506-0044, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA. Electronic address: Craig.Rush@uky.edu.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109974']
2934,32454356,Benefit-cost analysis of Promoting First Relationships®: Implications of victim benefits assumptions for return on investment.,"BACKGROUND
Child abuse and neglect (CAN) cost United States society $136 billion to $428 billion annually. Preventive interventions that reduce CAN may improve people's lives and generate economic benefits to society, but their magnitude is likely to vary greatly with assumptions about victim costs avoided through intervention.
OBJECTIVE
We examined the implications of different assumptions about avoided victim costs in a benefit-cost analysis of Promoting First Relationships® (PFR), a 10-session attachment and strengths-based home visiting intervention.
PARTICIPANTS AND SETTING
Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123).
METHODS
We monetized intervention effects on out-of-home placements and implicit effects on CAN and calculated net present values under three scenarios: (1) benefits from avoided system costs, (2) additional benefits from avoided tangible victim costs, and (3) additional benefits from avoided tangible and intangible quality-of-life victim costs. For scenarios 2 and 3, we varied the CAN effect size and estimated the effect size at which PFR was reliably cost beneficial.
RESULTS
PFR's societal net benefit ranged from $1 (scenario 1) to $5514 - $25,562 (scenario 2) and $7004 - $32,072 (scenario 3) (2014 USD). In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25.
CONCLUSIONS
PFR is cost beneficial assuming tangible victim costs are avoided by PFR. Research into the long-term health and economic consequences of reducing CAN in at-risk populations would contribute to comprehensive, accurate benefits models.",2020,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25.
",['Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123'],['Promoting First Relationships®'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}]",[],,0.0284117,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25.
","[{'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Kuklinski', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 Third Ave. NE, Suite 401, Seattle, WA 98115, United States. Electronic address: mrk63@uw.edu.'}, {'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Oxford', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mloxford@uw.edu.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Spieker', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: spieker@uw.edu.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Lohr', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mjlohr@uw.edu.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'Center for The Study of Health and Risk Behavior, Department of Psychiatry, University of Washington, United States. Electronic address: cnbflem@uw.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104515']
2935,32454417,Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy for laryngeal/hypopharyngeal cancer: Long-term results of the TREMPLIN randomised GORTEC trial.,"BACKGROUND
In Europe, induction chemotherapy (ICT) followed by radiotherapy is preferred to conventional chemoradiotherapy to avoid total laryngectomy in patients with laryngeal/hypopharyngeal cancer. In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
METHODS
Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma. Good responders after three cycles of docetaxel-cisplatin-5-fluorouracil (TPF)-ICT (docetaxel and cisplatin, 75 mg/m 2 each on day 1, and 5-fluorouracil, 750 mg/m 2 /day on days 1-5) every 3 weeks were randomised to receive radiotherapy (70 Gy) with concurrent cisplatin (100 mg/m 2 /day on days 1, 22 and 43 of radiotherapy) or cetuximab (400 mg/m 2 of loading dose, 250 mg/m 2 /week during radiotherapy). The primary end-point was larynx preservation. The secondary end-points were laryngo-oesophageal dysfunction-free survival (LEDFS), LCR and OS.
RESULTS
A total of 153 patients were enrolled. Among 126 TPF-ICT responders, 116 were randomised to receive either cisplatin (n = 60) or cetuximab (n = 56). The median follow-up was 77.5 months. Five-year OS rates were 66.6% (95% confidence interval [CI]: 0.54-0.79) versus 66.9% (95% CI: 0.54-0.79) (p = 0.9), respectively. Five-year LCRs were 79.8% (95% CI: 69.5-90.0) versus 67.8% (95% CI: 55.1-80.5%) (p = 0.18). Five-year LEDFS was 62.2% (95% CI: 49.7-74.8%) versus 56.2% (95% CI: 43.0-69.4) (p = 0.38). Late grade III/IV salivary gland and laryngeal toxicity occurred in 10.3% versus 9.8% and 6.8% versus 11.8% of patients receiving cisplatin-radiotherapy versus cetuximab, respectively.
CONCLUSIONS
No significant difference in LEDFS was observed between the two arms. TPF-ICT followed by conventional chemoradiotherapy or cetuximab was feasible, and long-term toxicity was not statistically different between the two arms. LEDFS appears as a relevant end-point.",2020,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","['Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma', '126 TPF-ICT responders', 'laryngeal/hypopharyngeal cancer', '153 patients were enrolled', 'patients with laryngeal/hypopharyngeal cancer']","['radiotherapy (70\xa0Gy) with concurrent cisplatin', 'cisplatin-radiotherapy', 'radiotherapy', 'LEDFS', 'cetuximab', 'conventional chemoradiotherapy', 'induction chemotherapy (ICT', 'Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy', 'cisplatin', 'conventional radiotherapy, bioradiotherapy with cetuximab', 'TPF)-ICT (docetaxel and cisplatin', '5-fluorouracil, 750\xa0mg/m 2', 'docetaxel-cisplatin-5-fluorouracil', 'TPF-ICT followed by conventional chemoradiotherapy or cetuximab']","['laryngo-oesophageal dysfunction-free survival (LEDFS), LCR\xa0and OS', 'LEDFS', 'locoregional control rates (LCRs) and overall survival (OS', 'larynx preservation', 'unmanageable toxicity', 'Late grade III/IV salivary gland and laryngeal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0153398', 'cui_str': 'Malignant tumor of hypopharynx'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}]",153.0,0.178683,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Janoray', 'Affiliation': 'Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D\'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France; EA 7505, ""Education Ethique Santé"", EES, Tours, France. Electronic address: guillaume.janoray@yahoo.fr.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Clinique Sainte Catherine, Avignon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, Lorient, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': 'Institut de Cancérologie de Lorraine, Vandoeuvre Lès Nancy, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Raucourt', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bardet', 'Affiliation': 'Centre René Gauducheau, Nantes, France.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Garaud', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.009']
2936,32442148,Patient Perception of Plain-Language Medical Notes Generated Using Artificial Intelligence Software: Pilot Mixed-Methods Study.,"BACKGROUND
Clinicians' time with patients has become increasingly limited due to regulatory burden, documentation and billing, administrative responsibilities, and market forces. These factors limit clinicians' time to deliver thorough explanations to patients. OpenNotes began as a research initiative exploring the ability of sharing medical notes with patients to help patients understand their health care. Providing patients access to their medical notes has been shown to have many benefits, including improved patient satisfaction and clinical outcomes. OpenNotes has since evolved into a national movement that helps clinicians share notes with patients. However, a significant barrier to the widespread adoption of OpenNotes has been clinicians' concerns that OpenNotes may cost additional time to correct patient confusion over medical language. Recent advances in artificial intelligence (AI) technology may help resolve this concern by converting medical notes to plain language with minimal time required of clinicians.
OBJECTIVE
This pilot study assesses patient comprehension and perceived benefits, concerns, and insights regarding an AI-simplified note through comprehension questions and guided interview.
METHODS
Synthea, a synthetic patient generator, was used to generate a standardized medical-language patient note which was then simplified using AI software. A multiple-choice comprehension assessment questionnaire was drafted with physician input. Study participants were recruited from inpatients at the University of Colorado Hospital. Participants were randomly assigned to be tested for their comprehension of the standardized medical-language version or AI-generated plain-language version of the patient note. Following this, participants reviewed the opposite version of the note and participated in a guided interview. A Student t test was performed to assess for differences in comprehension assessment scores between plain-language and medical-language note groups. Multivariate modeling was performed to assess the impact of demographic variables on comprehension. Interview responses were thematically analyzed.
RESULTS
Twenty patients agreed to participate. The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant. Age, ethnicity, and health literacy were found to have a significant impact on comprehension scores by multivariate modeling. Thematic analysis of guided interviews highlighted patients' perceived benefits, concerns, and suggestions regarding such notes. Major themes of benefits were that simplified plain-language notes may (1) be more useable than unsimplified medical-language notes, (2) improve the patient-clinician relationship, and (3) empower patients through an enhanced understanding of their health care.
CONCLUSIONS
AI software may translate medical notes into plain-language notes that are perceived as beneficial by patients. Limitations included sample size, inpatient-only setting, and possible confounding factors. Larger studies are needed to assess comprehension. Insight from patient responses to guided interviews can guide the future study and development of this technology.",2020,"The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant.","['Twenty patients agreed to participate', 'Study participants were recruited from inpatients at the University of Colorado Hospital']",['standardized medical language version or AI-generated plain-language version of the patient note'],"['mean number of comprehension assessment questions', 'Interview responses', 'comprehension assessment scores', 'comprehension scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.036171,"The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant.","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bala', 'Affiliation': 'College of Medicine, University of Central Florida, Orlando, FL, United States.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Keniston', 'Affiliation': 'Division of Hospital Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Marisha', 'Initials': 'M', 'LastName': 'Burden', 'Affiliation': 'Division of Hospital Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}]",JMIR formative research,['10.2196/16670']
2937,32442189,Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: A randomized controlled trial.,"BACKGROUND
Women living with HIV (WLHIV) have lower rates of contraceptive use than noninfected peers, yet concerns regarding contraceptive efficacy and interaction with antiretroviral therapy (ART) complicate counseling. Hormonal contraceptives may increase genital tract HIV viral load (gVL) and sexual transmission risk to male partners. We compared gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation between the levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD) in Cape Town, South Africa.
METHODS AND FINDINGS
In this double-masked, randomized controlled noninferiority trial, eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART). Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC. At all visits, participants provided specimens for gVL (primary outcome), pVL, RTI, and pregnancy testing. We assessed gVL and pVL across 6 and 24 months controlling for enrollment measures, ART group, age, and RTI using generalized estimating equation and generalized linear models (non-ART group pVL and hemoglobin) in as-treated analyses. We measured IUC discontinuation rates with Kaplan-Meier estimates and Cox proportional hazards models. We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women. Participant median age was 31 years, and 95% had 1 or more prior pregnancies. Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88). Among ART users, proportions with detectable pVL were not significantly different at 6 (AOR = 0.83, 95% CI 0.37-1.86, p = 0.65) and 24 months (AOR = 0.94, 95% CI 0.49-1.81, p = 0.85), whereas among non-ART women, mean pVL was not significantly different at 6 months (-0.10 log10 copies/mL, 95% CI -0.29 to 0.10, p = 0.50) between LNG-IUS and C-IUD users. IUC continuation was 78% overall; C-IUD users experienced significantly higher expulsion (8% versus 1%, p = 0.02) and elective discontinuation (adjusted hazard ratio: 8.75, 95% CI 3.08-24.8, p < 0.001) rates. Sensitivity analysis adjusted for differential IUC discontinuation found similar gVL results. There were 39 serious adverse events (SAEs); SAEs believed to be directly related to IUC use (n = 7) comprised 3 pelvic inflammatory disease (PID) cases and 4 pregnancies with IUC in place with no discernible trend by IUC arm. Mean hemoglobin change was significantly higher among LNG-IUS users across 6 (0.57 g/dL, 95% CI 0.24-0.90; p < 0.001) and 24 months (0.71 g/dL, 95% CI 0.47-0.95; p < 0.001). Limitations included not achieving non-ART group sample size following change in ART treatment guidelines and truncated 24 months' outcome data, as 17 women were not yet eligible for their 24-month visit at study closure. Also, a change in VL assay during the study may have caused some discrepancy in VL values because of different limits of detection.
CONCLUSIONS
In this study, we found that the LNG-IUS did not increase gVL or pVL and had low levels of contraceptive failure and associated PID compared with the C-IUD among WLHIV. LNG-IUS users were significantly more likely to continue IUC use and had higher hemoglobin levels over time. The LNG-IUS appears to be a safe contraceptive with regard to HIV disease and may be a highly acceptable option for WLHIV.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01721798.",2020,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","['women living with HIV in South Africa', 'Participant median age was 31 years, and 95% had 1 or more prior pregnancies', 'male partners', 'We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women', 'Cape Town, South Africa', 'eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART', 'Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent', 'Women living with HIV (WLHIV']","['Hormonal contraceptives', 'levonorgestrel intrauterine system', 'injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC', 'levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD']","['39 serious adverse events (SAEs); SAEs', 'gVL or pVL and had low levels of contraceptive failure and associated PID', 'Mean hemoglobin change', 'elective discontinuation', 'hemoglobin levels', 'pVL, RTI, and pregnancy testing', 'genital tract HIV viral load (gVL) and sexual transmission risk', 'mean pVL', 'gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation', 'expulsion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C2314882', 'cui_str': 'Genital Tract Infections'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009866', 'cui_str': 'Contraception failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031406', 'cui_str': 'Phenindione'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C1519279', 'cui_str': 'Sexual transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}]",71.0,0.642316,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","[{'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Todd', 'Affiliation': 'Maternal and Child Health and Nutrition Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology and Biostatistics, City University of New York School of Public Health, New York, New York, United States of America.'}, {'ForeName': 'Nontokozo', 'Initials': 'N', 'LastName': 'Langwenya', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': 'Department of Statistics and Institute for Health Care Policy and Aging Research, Rutgers University, Piscataway, New Jersey, United States of America.'}, {'ForeName': 'Pai-Lien', 'Initials': 'PL', 'LastName': 'Chen', 'Affiliation': 'Global Population and Health Research Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Petro', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003110']
2938,32442781,The impact of exposure therapy on stigma and mental health treatment attitudes among active duty U.S. soldiers with combat related PTSD.,"Although cognitive behavioral interventions improve attitudes toward mental health treatment and reduce stigma, little is known about which types of attitudes change, or how this change occurs. Active duty soldiers with PTSD (N = 162) were randomized to 10 sessions of exposure therapy or a waitlist. Soldiers were assessed for PTSD and completed measures of stigma and attitudes towards mental health services before randomization and after 5- and 10- sessions of therapy. At post-treatment, soldiers in exposure therapy demonstrated significant improvements in openness to talking about mental health problems and concerns about what others may think if they knew they were seeking mental health treatment, relative to those in the waitlist. There were significant indirect effects from treatment to changes in stigma and attitudes towards mental health treatment through changes in PTSD symptoms at post-treatment. There was also a significant indirect effect from treatment to changes in stigma at post-treatment through changes in attitudes towards mental health treatment at mid-treatment, suggesting attitude change may occur first. Baseline characteristics did not moderate treatment's change in stigma or attitudes. Improvements in PTSD symptoms and positive changes in attitudes towards mental health treatment appear to separately predict later reductions in stigma.",2020,"At post-treatment, soldiers in exposure therapy demonstrated significant improvements in openness to talking about mental health problems and concerns about what others may think if they knew they were seeking mental health treatment, relative to those in the waitlist.","['stigma and mental health treatment attitudes among active duty U.S. soldiers with combat related PTSD', 'Active duty soldiers with PTSD (N\xa0=\xa0162']","['exposure therapy', 'cognitive behavioral interventions', 'exposure therapy or a waitlist']","['stigma and attitudes towards mental health services', 'openness to talking about mental health problems', 'stigma or attitudes']","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0547049', 'cui_str': 'Openness'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}]",162.0,0.0278219,"At post-treatment, soldiers in exposure therapy demonstrated significant improvements in openness to talking about mental health problems and concerns about what others may think if they knew they were seeking mental health treatment, relative to those in the waitlist.","[{'ForeName': 'Greg M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'VA Puget Sound Health Care System, 9600 Veterans Drive, A-116, Tacoma, WA, 98493, United States; University of Washington School of Medicine, 1959 NE Pacific St, Box 356560, Seattle, WA, 98195-6560, United States. Electronic address: greg.reger@va.gov.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Bourassa', 'Affiliation': 'VA Puget Sound Health Care System, 9600 Veterans Drive, A-116, Tacoma, WA, 98493, United States; Duke University Medical Center, Center for Aging and Human Development, 2020 W. Main St., Durham, NC, 27707, United States.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'VISN 20 Northwest Network Mental Illness Research, Education and Clinical Center (MIRECC), 1660 S. Columbian Way, Seattle, WA, 98108, United States; University of Washington School of Medicine, 1959 NE Pacific St, Box 356560, Seattle, WA, 98195-6560, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'VA Puget Sound Health Care System, 9600 Veterans Drive, A-116, Tacoma, WA, 98493, United States; University of Washington School of Medicine, 1959 NE Pacific St, Box 356560, Seattle, WA, 98195-6560, United States.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.005']
2939,32442828,Subgroup analysis of the early paracetamol trial to preterm infants found haemodynamic changes and improved oxygenation.,"BACKGROUND
We previously reported in a randomised trial that early intravenous paracetamol accelerated contraction of ductus arteriosus in very preterm infants (<32 gestation weeks).
AIMS
To monitor sequentially paracetamol effects on the blood pressure and brain tissue oxygenation in the infants participating the trial.
METHODS
In a double-blind trial, intravenous paracetamol or placebo was infused to 48 very premature infants starting within 24 h of birth for four days. Besides the ductus arteriosus, we systematically measured blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE) during the study period.
RESULTS
Compared to the placebo, the paracetamol loading dose transiently decreased the arterial blood pressure. During treatment, the paracetamol-treated infants had higher spO 2 (p = .042) and rcSO 2 (p = .036) values than the placebo group infants. Additionally, the cFTOE values were lower in the paracetamol group during the study without statistical significance. All infants with closed ductus had higher tissue oxygenation and a lower cFTOE than infants with open ductus.
CONCLUSIONS
Paracetamol caused modest haemodynamic effects and increased cerebral oxygenation. They were mostly due to early contraction of ductus. Additional direct drug-effects in brain are not ruled-out.",2020,"During treatment, the paracetamol-treated infants had higher spO 2 (p = .042) and rcSO 2 (p = .036) values than the placebo group infants.","['very preterm infants (<32 gestation weeks', '48 very premature infants starting within 24\u202fh of birth for four days', 'infants participating the trial']","['paracetamol', 'intravenous paracetamol or placebo', 'Paracetamol', 'placebo']","['haemodynamic effects', 'haemodynamic changes and improved oxygenation', 'tissue oxygenation', 'arterial blood pressure', 'blood pressure and brain tissue oxygenation', 'blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE', 'cerebral oxygenation']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",48.0,0.459725,"During treatment, the paracetamol-treated infants had higher spO 2 (p = .042) and rcSO 2 (p = .036) values than the placebo group infants.","[{'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Härmä', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Aikio', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland. Electronic address: outi.aikio@ppshp.fi.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Härkin', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Leskinen', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Valkama', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Saarela', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}]",Early human development,['10.1016/j.earlhumdev.2020.105042']
2940,32445558,Effect of Electroacupuncture on Postoperative Gastrointestinal Recovery in Patients Undergoing Thoracoscopic Surgery: A Feasibility Study.,"BACKGROUND The aim of this study was to study the feasibility and acceptability of electroacupuncture (EA) for preventing postoperative gastrointestinal complications in patients undergoing thoracoscopic segmentectomy/lobectomy. MATERIAL AND METHODS Sixty patients who underwent video-assisted thoracoscopic (VATS) segmentectomy/lobectomy received either EA treatments plus usual care (EA group) or usual care alone (UC group). Patients in the EA group were given 30 minutes of bilateral electroacupuncture on 3 acupoints [Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37)] at 3 time points (24 hours before surgery, and 4 hours and 24 hours after surgery). The primary outcomes were recruitment, retention, acceptability of the EA intervention, incidence and severity of abdominal distension (AD), and time to first flatus and defecation. Secondary outcomes included postoperative nausea and vomiting (PONV), pain intensity, and duration of hospital stay. RESULTS We recruited 60 participants and 59 were randomized into 2 groups for this study: 30 in the EA group and 29 in the UC group. In total, 57 participants completed the study. With the exception of one participant in the EA group, all participants completed all three sessions of EA. The one exclusion was a case where a paravertebral block was not used during the surgery. Qualitative findings from the acceptability questionnaire indicated that participants viewed the EA treatment as acceptable. After EA treatment, there was a small but statistically significant improvement in participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort (P=0.001). The EA group showed improved outcomes compared to the UC group in terms of time to first flatus (20.8±4.6 versus 24.1±6.2 hours, P=0.026) and defecation (53.9±6.0 versus 57.5±7.2 hours, P=0.046). No significant differences appeared regarding AD, rescue medication, or duration of hospitalization. PONV and pain intensity were similar in both groups at the recorded time periods. CONCLUSIONS EA is feasible and acceptable to patients undergoing VATS surgery. Our preliminary findings of EA promoting postoperative recovery of gastrointestinal function warrants large randomized controlled trials.",2020,"After EA treatment, there was a small but statistically significant improvement in participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort (P=0.001).","['57 participants completed the study', 'Sixty patients who underwent', '60 participants and 59 were randomized into 2 groups for this study: 30 in the EA group and 29 in the UC group', 'patients undergoing VATS surgery', 'patients undergoing thoracoscopic segmentectomy/lobectomy', 'Patients Undergoing Thoracoscopic Surgery']","['electroacupuncture (EA', 'Electroacupuncture', 'bilateral electroacupuncture on 3 acupoints [Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37', 'EA', 'video-assisted thoracoscopic (VATS) segmentectomy/lobectomy received either EA treatments plus usual care (EA group) or usual care alone (UC group']","['time to first flatus', 'PONV and pain intensity', 'postoperative nausea and vomiting (PONV), pain intensity, and duration of hospital stay', 'defecation', 'recruitment, retention, acceptability of the EA intervention, incidence and severity of abdominal distension (AD), and time to first flatus and defecation', 'AD, rescue medication, or duration of hospitalization', 'Postoperative Gastrointestinal Recovery', ""participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort"", 'postoperative gastrointestinal complications']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0450534', 'cui_str': 'ST37'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}]",60.0,0.0873528,"After EA treatment, there was a small but statistically significant improvement in participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort (P=0.001).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Libing', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Siying', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Wenzhong', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Weiqian', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'School of Health and Biomedical Sciences, Royal Melbourne Institute of Technology (RMIT) University, Melbourne, Australia.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': 'Department of Pharmacology, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Fangbing', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.920648']
2941,32446164,Determination of levels of oxidative stress and nitrosative stress in patients with epilepsy.,"BACKGROUND
Epilepsy is one of the most common neurological diseases. The underlying pathophysiological mechanisms in epilepsy are still unknown. Oxidative stress is believed to be one of the factors involved in the pathogenesis of epileptogenesis. In various pathophysiological conditions, reactive nitrogen species (RNS) such as nitrogen and peroxynitrite are produced and these RNSs can bind to free nucleosides and nucleotides or to nucleosides and nucleotides existing in the DNA/RNA structure. 8-Nitroguanine (8-NG) is a typical DNA nucleobase product of nitrosative damage generated by RNS. It has been proposed that F2-isoprostanes, in particular 8-iso-Prostaglandin F2α (8-isoPGF2α), are specific, reliable and non-invasive biomarkers of lipid peroxidation in vivo. In the present study, we compared the levels of lipid oxidative stress biomarker 8-isoPGF2α and nitrosative stress DNA biomarker 8-NG in patients with epilepsy undergoing antiepileptic drug (AEDs) treatment and with those in healthy participants.
METHODS
The present study comprised 90 patients aged between 17 and 53 who were admitted to the Neurology Clinic of Cumhuriyet University and diagnosed with epilepsy. The patients were assigned into the intervention (n = 45) and control (n = 45) groups. Of the participants in the intervention group, 37.7% (n = 17) were treated with levetiracetam (LEV), 33.3% (n = 15) with valproic acid (VA) and 29% (n = 13) with carbamazepine. Serum 8-iso-PGF2α and 8-NG levels of the participants in the intervention and control groups were determined by ELISA.
RESULTS
There was no significant difference between the medication (LEV, VA, Carbamazepine) used by the participants and their 8-iso-PGF2α and 8-NG levels (p > 0.05). However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001).
CONCLUSION
Our study demonstrated that there was an increase in oxidative and nitrosative stres markers in patients with epilepsy. There was no significant difference between the 8-iso-PGF2α and 8-NG levels of the participants taking three different AEDs.",2020,"However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001).
","['patients with epilepsy undergoing antiepileptic drug (AEDs) treatment and with those in healthy participants', 'patients with epilepsy', '90 patients aged between 17 and 53 who were admitted to the Neurology Clinic of Cumhuriyet University and diagnosed with epilepsy']","['levetiracetam (LEV', 'valproic acid (VA', 'lipid oxidative stress biomarker 8-isoPGF2α and nitrosative stress DNA biomarker 8-NG', 'carbamazepine', '8-Nitroguanine']","['Serum 8-iso-PGF2α and 8-NG levels', 'oxidative stress and nitrosative stress', 'medication (LEV, VA, Carbamazepine', '8-iso-PGF2α and 8-NG', '8-iso-PGF2α and 8-NG levels', 'oxidative and nitrosative stres markers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0381956', 'cui_str': '8-nitroguanine'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0381956', 'cui_str': '8-nitroguanine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",90.0,0.0414708,"However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001).
","[{'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Ersan', 'Affiliation': 'Nigde Ömer Halisdemir University, Medical Faculty, Department of Biochemistry, Niğde, Turkey. Electronic address: serpilersan@gmail.com.'}, {'ForeName': 'Burhanettin', 'Initials': 'B', 'LastName': 'Cigdem', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Neurology, Sivas, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Bakir', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Biochemistry, Sivas, Turkey.'}, {'ForeName': 'H Okan', 'Initials': 'HO', 'LastName': 'Dogan', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Biochemistry, Sivas, Turkey.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106352']
2942,32446170,"Independent and combined effect of home-based progressive resistance training and nutritional supplementation on muscle strength, muscle mass and physical function in dynapenic older adults with low protein intake: A randomized controlled trial.","BACKGROUND
With the aging phenomenon, there is growing interest in developing effective strategies to counteract dynapenia, the age-related loss of muscle strength. The positive effect of progressive resistance training on muscle strength is well known, however, the effect of nutritional supplementation or its synergistic effect along with exercise on muscle strength is not a consensus in the literature, especially in populations with low protein intake.
METHODS
We analyzed the muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test) of 69 dynapenic older adults with low protein intake, before and after the intervention period of three months. The participants were randomly allocated into four groups: resistance training, supplementation, resistance training plus supplementation, and control.
RESULTS
There was a significant group x time interaction on the following outcome measures: handgrip strength (p < 0.001), gait speed (p = 0.023), and sit-to-stand test (p < 0.001). Considering the outcomes that showed a significant difference between and within groups, only the resistance training group and the resistance training plus supplementation group showed a large effect size in handgrip strength, gait speed, and sit-to-stand test, whereas the supplementation group showed a moderate effect size in gait speed. After the intervention period, there was no difference between the resistance training and the resistance training plus supplementation groups.
CONCLUSION
This study reinforces the value of resistance training in improving muscle strength. The nutritional supplementation added no further benefits in this specific population. Registration number at the Brazilian registry of clinical trials: RBR-4HRQJF.",2020,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p < 0.001), gait speed (p = 0.023), and sit-to-stand test (","['dynapenic older adults with low protein intake', '69 dynapenic older adults with low protein intake, before and after the intervention period of three months']","['home-based progressive resistance training and nutritional supplementation', 'progressive resistance training', 'resistance training, supplementation, resistance training plus supplementation, and control']","['muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test', 'gait speed', 'sit-to-stand test ', 'muscle strength, muscle mass and physical function', 'handgrip strength', 'moderate effect size in gait speed', 'handgrip strength, gait speed, and sit-to-stand test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0382378,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p < 0.001), gait speed (p = 0.023), and sit-to-stand test (","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'de Carvalho Bastone', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: ale.bastone@gmail.com.'}, {'ForeName': 'Luciana Neri', 'Initials': 'LN', 'LastName': 'Nobre', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: lunerinobre@yahoo.com.br.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'de Souza Moreira', 'Affiliation': 'Postgraduate Program in Public Health - Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: onurbsm@yahoo.com.br.'}, {'ForeName': 'Iramaya Francielle', 'Initials': 'IF', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: iramayafranciellerosa@hotmail.com.'}, {'ForeName': 'Gabrielle Bemfica', 'Initials': 'GB', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: gabi_bferreira@hotmail.com.'}, {'ForeName': 'Dayane Deyse Lee', 'Initials': 'DDL', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: dayanedls@hotmail.com.'}, {'ForeName': 'Nancy Krysna Sancha Silva', 'Initials': 'NKSS', 'LastName': 'Monteiro', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: krysnancymonteiro@gmail.com.'}, {'ForeName': 'Michelle Dullya', 'Initials': 'MD', 'LastName': 'Alves', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: mih.dullya@gmail.com.'}, {'ForeName': 'Rômulo Amaral', 'Initials': 'RA', 'LastName': 'Gandra', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: romulogandra@yahoo.com.br.'}, {'ForeName': 'Elane Marinho', 'Initials': 'EM', 'LastName': 'de Lira', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: e.lira.fisio@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104098']
2943,32446172,Effects of 'participatory group-based care management' on wellbeing of older people living alone: a randomized controlled trial.,"BACKGROUND AND OBJECTIVES
More knowledge is needed of the effectiveness of complex interventions that aim to promote the wellbeing of older people. This study examines the effects of 'participatory group-based care management' conducted among community-dwelling older adults living alone in Central and Eastern Finland. The intervention aimed to promote wellbeing and quality of life (QoL) using a needs-based and participatory approach.
METHODS
The study was carried out as a randomized control trial (intervention group n = 185, control group n = 207). In this article, baseline and 6-month follow-up surveys were used. QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust) were used as outcome measurements, and generalized estimating equations (GEE) modeling as the analysis method. Both per-protocol and intention-to-treat analyses were applied.
RESULTS
According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline. Additionally, the intervention enhanced trust in other people and some dimensions of institutional trust. The intention-to-treat analysis did not result in any significant effects on QoL or loneliness, but some small positive changes in institutional trust were found.
CONCLUSIONS
Based on some evidence of small positive effects, the intervention may be beneficial in alleviating loneliness and enhancing trust among older people living alone. Because of the contradictory results, more research is needed to examine the complexity of 'participatory group-based care management´ from the perspective of process evaluation.",2020,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","['older people', 'community-dwelling older adults living alone in Central and Eastern Finland', 'older people living alone']",['participatory group-based care management'],"['QoL or loneliness', 'wellbeing and quality of life (QoL', 'QoL. Loneliness', 'QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0856593,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Ristolainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Kannasoja', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Tiilikainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hakala', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Närhi', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Rissanen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104095']
2944,32446176,"Efficacy and safety of safinamide as an add-on therapy to L-DOPA for patients with Parkinson's disease: A randomized, double-blind, placebo-controlled, phase II/III study.","INTRODUCTION
Safinamide is a reversible and selective monoamine oxidase-B (MAO-B) and sodium channel inhibitor with demonstrated efficacy in mid-to late-stage Parkinson's disease (PD) as an adjunct to l-DOPA. This study aimed to confirm the efficacy and safety of safinamide in PD patients with wearing-off.
METHODS
This 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study included Japanese PD patients with wearing-off on l-DOPA treatment. Patients were randomized to receive placebo (P), safinamide 50 mg/day (S50), or safinamide 100 mg/day (S100). The primary endpoint was the change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time). Other measures included the changes in mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index.
RESULTS
A total of 406 subjects were randomized, of whom 349 completed the study. Baseline characteristics were balanced. Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group. Changes from baseline in mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part I also showed significant improvements. Adverse events occurred in 58.9%, 60.2%, and 61.4% of the P, S50, and S100 groups, respectively. The most common adverse drug reactions were dyskinesias (2.1%, 8.3%, and 10.6%) and visual hallucinations (1.4%, 3.0%, and 4.5%).
CONCLUSION
As an adjunct to l-DOPA, safinamide safely increased ON-time and improved PD symptoms/signs in PD patients with wearing-off.",2020,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[""patients with Parkinson's disease"", 'PD patients with wearing-off', 'Japanese PD patients with wearing-off on l-DOPA treatment', 'A total of 406 subjects were randomized, of whom 349 completed the study']","['sodium channel inhibitor', 'safinamide', 'placebo (P), safinamide 50\xa0mg/day (S50), or safinamide 100\xa0mg/day (S100', 'placebo']","['Adverse events', 'dyskinesias', 'Efficacy and safety', 'mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part', 'visual hallucinations', 'mean daily ON-time', 'efficacy and safety', ""mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index"", 'change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time', 'ON-time and improved PD symptoms/signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C1098261', 'cui_str': 'safinamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4475891', 'cui_str': 'safinamide 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4475900', 'cui_str': 'safinamide 100 MG'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0233763', 'cui_str': 'Visual hallucinations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",406.0,0.175291,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan. Electronic address: nhattori@juntendo.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: akihiko.yamamoto@meiji.com.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Sasagawa', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: yuuji.sasagawa@meiji.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Graduate School of Medicine, Ehime University, Shizugawa, Tohon, Ehime, 791-0295, Japan; Saiseikai Imabari Center for Health and Welfare, 7-6-1 Kitamura, Imabari, Ehime, 799-1592, Japan. Electronic address: nomoto@m.ehime-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.04.012']
2945,32446787,"Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial.","BACKGROUND & AIMS
In preterm infants, natural variation of breast milk composition makes it difficult to achieve recommended macronutrient intakes with standard fortification. Evidence suggests that nutritional deficiency induces poor postnatal growth. This study investigates impacts of target fortification on preterm growth and metabolism by adjusting breast milk macronutrients.
METHODS
This study was conducted as a single-centre, double-blind, randomized controlled trial for infants <30 gestational weeks. The control group received standard fortification and the intervention group received standard plus target fortification adding modular protein, lipids, and carbohydrates. Breast milk content was measured 3x/week using a validated near-infrared bedside spectrometer (NIRS). Modulars were added to achieve recommended values. To assess total nutrient intake, all 2810 native breast milk samples were analyzed - protein and fat using bedside-NIRS, lactose using tandem mass spectrometry (UPLC-MS/MS). Body composition was measured using air displacement plethysmography. Primary outcome was weight gain during the first 21 days of intervention.
RESULTS
Baseline characteristics, morbidities, and total fluid intake were not different between groups (intervention n = 52, control n = 51). The intervention group infants had higher macronutrient intakes, weight gain (21.2 ± 2.5 vs 19.3 ± 2.4 g/kg/d, mean difference: 1.9 g/kg/d, 95% CI: 0.9 - 2.9), and body weight. Infants in the intervention group from mothers with below-average breast milk protein content showed greatest impact on weight at 36 weeks (2580 ± 280 g vs 2210 ± 300 g), length, head circumference, fat, and fat-free mass. Also, feeding intolerance was less frequent, blood urea was higher, and triglycerides were lower.
CONCLUSIONS
This study provides evidence that target fortification of breast milk with low macronutrient content enhances the quality of nutrition and growth and is feasible in clinical routine.",2020,"Infants in the intervention group from mothers with below-average breast milk protein content showed greatest impact on weight at 36 weeks (2580 ± 280 g vs 2210 ± 300 g), length, head circumference, fat, and fat-free mass.","['21.2\xa0±\xa02.5 vs 19.3\xa0±\xa02.4\xa0g/kg/d, mean difference', '2810 native breast milk samples', 'infants <30 gestational weeks', 'preterm infants']","['standard fortification and the intervention group received standard plus target fortification adding modular protein, lipids, and carbohydrates']","['blood urea', 'Body composition', 'higher macronutrient intakes, weight gain', 'body weight', 'weight gain', 'morbidities, and total fluid intake', 'preterm growth and metabolism']","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.415734,"Infants in the intervention group from mothers with below-average breast milk protein content showed greatest impact on weight at 36 weeks (2580 ± 280 g vs 2210 ± 300 g), length, head circumference, fat, and fat-free mass.","[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Rochow', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada; Department of Pediatrics, Paracelsus Medical School, General Hospital of Nuremberg, Nuremberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Fusch', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Anaam', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Akshdeep', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hon Yiu', 'Initials': 'HY', 'LastName': 'So', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Iskander', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Chessell', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salhab', 'Initials': 'S', 'LastName': 'El Helou', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Fusch', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada; Department of Pediatrics, Paracelsus Medical School, General Hospital of Nuremberg, Nuremberg, Germany. Electronic address: christoph.fusch@klinikum-nuernberg.de.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.04.031']
2946,32447339,Tragus Nerve Stimulation Suppresses Post-Infarction Ventricular Arrhythmia by Modulating Autonomic Activity and Heterogeneities of Cardiac Receptor Distribution.,"BACKGROUND Imbalanced cardiac autonomic control and cardiac receptors redistribution contribute to the arrhythmogenic substrate under the myocardial infarction (MI) condition. Stimulating the auricular branch of vagus nerve (AB-VNS) has been proven to reduce post-infarction ventricular arrhythmia (VAs), but its potential mechanisms were largely unknown. This study aimed to investigate whether long-term intermittent low-intensity AB-VNS could produce a protective effect on modulating autonomic activities and abnormal redistribution of autonomic nerve efferent receptors in a MI canine model. MATERIAL AND METHODS Twelve healthy beagle dogs underwent ligation of the left anterior descending coronary artery to establish a MI model and were randomized into 2 groups: an AB-VNS group, (AB-VNS for 4 weeks) and a control group (sham stimulation for 4 weeks). Dynamic electrocardiogram recording, neural recording, catecholamine concentration, and histological studies were conducted subsequently. RESULTS Compared to the control group, the AB-VNS group had significantly suppressed post-infarction VAs, reduced low frequency (LF) power and increased high frequency (HF) power. In the AB-VNS group, with the progression of reduced cardiac sympathetic activities and augmented cardiac parasympathetic activities, the catecholamine concentration in heart tissue declined in the peripheral infarction area and right ventricle (RV); tyrosine hydroxylase (TH)-positive neurons decreased in the inferior cardiac sympathetic nerve, and choline acetyltransferase (ChAT)-positive neurons increased in the cervical vagus nerve. Expression of TrkA and P75NGFR were reduced in the peripheral MI (peri-MI) and non-MI area with AB-VNS. The mRNA expression of adrenergic and nicotinic receptors (ß₁-AR, ß₃-AR, and CHRNA7) significantly declined in the peri-MI and non-MI area of the AB-VNS group. CONCLUSIONS Chronic intermittent low-intensity AB-VNS effectively suppressed post-infarction VAs by potentially rebalancing extracardiac intrathoracic autonomic activities, reducing excessive cardiac sympathetic denervation, and attenuating the heterogeneities of cardiac efferent nerve receptors distribution.",2020,Expression of TrkA and P75NGFR were reduced in the peripheral MI (peri-MI) and non-MI area with AB-VNS.,['Twelve healthy beagle dogs underwent'],"['AB-VNS group, (AB-VNS for 4 weeks) and a control group (sham stimulation', 'vagus nerve (AB-VNS', 'ligation of the left anterior descending coronary artery to establish a MI model']","['post-infarction VAs, reduced low frequency (LF) power and increased high frequency (HF) power', 'mRNA expression of adrenergic and nicotinic receptors (ß₁-AR, ß₃-AR, and CHRNA7', 'peripheral infarction area and right ventricle (RV); tyrosine hydroxylase (TH)-positive neurons', 'Expression of TrkA and P75NGFR', 'cardiac sympathetic activities and augmented cardiac parasympathetic activities, the catecholamine concentration in heart tissue']","[{'cui': 'C0324306', 'cui_str': 'Beagle'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0042276', 'cui_str': 'Vagus nerve structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034830', 'cui_str': 'Nicotinic receptor'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0041491', 'cui_str': 'Tyrosine 3-monooxygenase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027882', 'cui_str': 'Neuron'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1272575', 'cui_str': 'Heart tissue'}]",12.0,0.0164927,Expression of TrkA and P75NGFR were reduced in the peripheral MI (peri-MI) and non-MI area with AB-VNS.,"[{'ForeName': 'Huaxin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Buajieer-Guli', 'Initials': 'BG', 'LastName': 'Nasi-Er', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Fifth Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Yaodong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'Lianwei', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""Department of Cardiology, People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China (mainland).""}, {'ForeName': 'Qina', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}, {'ForeName': 'BaoPeng', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiac Pacing and Electrophysiology, Heart Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922277']
2947,32448171,Metastasis-directed therapy in castration-refractory prostate cancer (MEDCARE): a non-randomized phase 2 trial.,"BACKGROUND
Patients diagnosed with metastatic castration-refractory prostate cancer (mCRPC) rely on a limited number of therapeutic agents resulting in a median survival of 2-3 years. A subgroup of those patients with mCRPC presents with oligoprogressive disease, with a limited number of progressive lesions while other metastases are still controlled by ongoing systemic treatment.
METHODS
In this single arm prospective phase II trial, we aim to include 18 patients with oligoprogressive mCRPC (1-3 metastases and/or local recurrence) who will be treated with metastasis-directed therapy to all visible progressive lesions. Progression is based on conventional imaging, as the use of PSMA PET-CT is considered investigational. However all patients will undergo PSMA PET-CT and the images will be blinded until progression. Primary endpoint is the postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT. Recruitment of patients for this trial started in January 2020 and will be completed approximately by December 2020.
DISCUSSION
In this phase 2 trial on oligoprogressive mCRPC, we will investigate the benefit of progression-directed therapy while continuing ongoing systemic treatment. We hypothesize that progression-directed therapy (PDT) with surgery or stereotactic body radiation therapy for these oligoprogressive lesions will postpone the start of next-line systemic treatment and therefore serve as a new or add-on therapy in the spectrum of treatments available for mCRPC. The results of this trial will serve as guidance for a later randomized phase 3 trial. All participants are given an information sheet and are required to give written informed consent. Results will be published in a peer-reviewed journal.
TRIAL REGISTRATION
This study is registered at ClinicalTrials.gov: NCT04222634 (December 18th 2019).",2020,Primary endpoint is the postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT.,"['Patients diagnosed with metastatic castration-refractory prostate cancer (mCRPC', 'castration-refractory prostate cancer (MEDCARE', '18 patients with oligoprogressive mCRPC (1-3 metastases and/or local recurrence) who will be treated with metastasis-directed therapy to all visible progressive lesions']","['progression-directed therapy (PDT) with surgery or stereotactic body radiation therapy', 'Metastasis-directed therapy']",['postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",18.0,0.190845,Primary endpoint is the postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT.,"[{'ForeName': 'Charlien', 'Initials': 'C', 'LastName': 'Berghen', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium. charlien.berghen@uzleuven.be.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kato', 'Initials': 'K', 'LastName': 'Rans', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Devos', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Poels', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Slabbaert', 'Affiliation': 'Department of Urology, RZ Tienen, Tienen, Belgium.'}, {'ForeName': 'Herlinde', 'Initials': 'H', 'LastName': 'Dumez', 'Affiliation': 'Department of Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Albersen', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Karolien', 'Initials': 'K', 'LastName': 'Goffin', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Haustermans', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'De Meerleer', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.'}]",BMC cancer,['10.1186/s12885-020-06853-x']
2948,32448177,"The effect of high dietary fiber intake on gestational weight gain, fat accrual, and postpartum weight retention: a randomized clinical trial.","BACKGROUND
Interventions to prevent excessive gestational weight gain (GWG) have had limited success This pilot study examined the effectiveness of a single goal (SG) high dietary fiber intervention to prevent excessive GWG.
METHODS
Twelve weekly lessons focused on consuming a high fiber diet (≥30 g/day). Snacks containing 10-12 g of dietary fiber were given for the first 6 weeks only. Body composition was measured at baseline and at the end of the intervention. At one-year postpartum, body weight retention and dietary practices were assessed. A p-value is reported for the primary analysis only. For all other comparisons, Cohen's d is reported to indicate effect size.
RESULTS
The SG group increased fiber intake during the study (32 g/day at 6 weeks, 27 g/day at 12 weeks), whereas the UC group did not (~ 17 g/day). No differences were found for the proportion of women classified as excessive gainers (p = 0.13). During the intervention, the SG group gained less body weight (- 4.1 kg) and less fat mass (- 2.8 kg) (d = 1.3). At 1 year postpartum, the SG group retained less weight (0.35 vs. 4.4 kg, respectively, d = 1.8), and reported trying to currently eat high fiber foods.
CONCLUSION
The SG intervention resulted in less weight gain, fat accrual, and weight retention at 1 year postpartum. A residual intervention effect was detected postpartum with the participants reporting continued efforts to consume a high fiber diet.
TRIAL REGISTRATION
NCT03984630; Trial registered June 13, 2019 (retrospectively registered).",2020,"At 1 year postpartum, the SG group retained less weight (0.35 vs. 4.4 kg, respectively, d = 1.8), and reported trying to currently eat high fiber foods.
",[],"['single goal (SG) high dietary fiber intervention', 'SG intervention', 'high dietary fiber intake']","['weight gain, fat accrual, and weight retention', 'gestational weight gain, fat accrual, and postpartum weight retention', 'weight', 'Body composition', 'body weight', 'excessive gestational weight gain (GWG', 'fat mass', 'proportion of women classified as excessive gainers', 'fiber intake', 'body weight retention and dietary practices']",[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",,0.0745225,"At 1 year postpartum, the SG group retained less weight (0.35 vs. 4.4 kg, respectively, d = 1.8), and reported trying to currently eat high fiber foods.
","[{'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Hull', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA. hhull@kumc.edu.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Herman', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gibbs', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Krase', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Kansas Hospital, Kansas City, KS, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Carlson', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Goetz', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, 3901 Rainbow BLVD, MS 4013, Kansas City, KS, 66160, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03016-5']
2949,32448374,REDUCE (Reviewing long-term antidepressant use by careful monitoring in everyday practice) internet and telephone support to people coming off long-term antidepressants: protocol for a randomised controlled trial.,"BACKGROUND
Around one in ten adults take antidepressants for depression in England, and their long-term use is increasing. Some need them to prevent relapse, but 30-50% could possibly stop them without relapsing and avoid adverse effects and complications of long-term use. However, stopping is not always easy due to withdrawal symptoms and a fear of relapse of depression. When general practitioners review patients on long-term antidepressants and recommend to those who are suitable to stop the medication, only 6-8% are able to stop. The Reviewing long-term antidepressant use by careful monitoring in everyday practice (REDUCE) research programme aims to identify safe and cost-effective ways of helping patients taking long-term antidepressants taper off treatment when appropriate.
METHODS
Design: REDUCE is a two-arm, 1:1 parallel group randomised controlled trial, with randomisation clustered by participating family practices.
SETTING
England and north Wales.
POPULATION
patients taking antidepressants for longer than 1 year for a first episode of depression or longer than 2 years for repeated episodes of depression who are no longer depressed and want to try to taper off their antidepressant use.
INTERVENTION
provision of 'ADvisor' internet programmes to general practitioners or nurse practitioners and to patients designed to support antidepressant withdrawal, plus three patient telephone calls from a psychological wellbeing practitioner. The control arm receives usual care. Blinding of patients, practitioners and researchers is not possible in an open pragmatic trial, but statistical and health economic data analysts will remain blind to allocation.
OUTCOME MEASURES
the primary outcome is self-reported nine-item Patient Health Questionnaire at 6 months for depressive symptoms.
SECONDARY OUTCOMES
depressive symptoms at other follow-up time points, anxiety, discontinuation of antidepressants, social functioning, wellbeing, enablement, quality of life, satisfaction, and use of health services for costs.
SAMPLE SIZE
402 patients (201 intervention and 201 controls) from 134 general practices recruited over 15-18 months, and followed-up at 3, 6, 9 and 12 months. A qualitative process evaluation will be conducted through interviews with 15-20 patients and 15-20 practitioners in each arm to explore why the interventions were effective or not, depending on the results.
DISCUSSION
Helping patients reduce and stop antidepressants is often challenging for practitioners and time-consuming for very busy primary care practices. If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups.
TRIAL REGISTRATION
ISRCTN:12417565. Registered on 7 October 2019.",2020,"If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups.
","['402 patients (201 intervention and 201 controls) from 134 general practices recruited over 15-18\u2009months, and followed-up at 3, 6, 9 and 12\u2009months', 'England and north Wales', 'interviews with 15-20 patients and 15-20 practitioners', 'patients taking antidepressants for longer than 1 year for a first episode of depression or longer than 2 years for repeated episodes of depression who are no longer depressed and want to try to taper off their antidepressant use']","[""provision of 'ADvisor' internet programmes to general practitioners or nurse practitioners and to patients designed to support antidepressant withdrawal, plus three patient telephone calls from a psychological wellbeing practitioner""]","['self-reported nine-item Patient Health Questionnaire at 6\u2009months for depressive symptoms', 'depressive symptoms at other follow-up time points, anxiety, discontinuation of antidepressants, social functioning, wellbeing, enablement, quality of life, satisfaction, and use of health services for costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.115424,"If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups.
","[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Kendrick', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK. A.R.Kendrick@soton.ac.uk.'}, {'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Bowers', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Leydon', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Department of Health Services Research and Policy, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Guiqing', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, Leicester, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': ""O'Brien"", 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Glowacka', 'Affiliation': 'Department for Rehabilitation and Sport Sciences, Faculty of Health and Social Sciences, Bournemouth University, Bournemouth, UK.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Holley', 'Affiliation': 'School of Psychology, Building 44 Highfield Campus, University of Southampton, Southampton, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dewar-Haggart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Palmer', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bell', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Collinson', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Fry', 'Affiliation': 'School of Psychology, Building 44 Highfield Campus, University of Southampton, Southampton, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton and University Hospitals Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, Seebohm Rowntree Building, University of York, York, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Moncrieff', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Macleod', 'Affiliation': 'Hull York Medical School, Allam Medical Building, University of Hull, Hull, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dowrick', 'Affiliation': 'Institute of Psychology Health and Society, University of Liverpool, Liverpool, UK.'}]",Trials,['10.1186/s13063-020-04338-7']
2950,32448382,"Biphasic human insulin 30 thrice daily, is it reasonable?","OBJECTIVE
To evaluate the efficacy and safety of thrice daily Biphasic Human Insulin 30 (BHI 30) versus the traditional twice-daily regimen in type 2 diabetes mellitus (T2DM) patients. It's a cross over single clinical study. Twenty-two diabetic patients who were already using BHI 30 in twice or thrice daily regimens with or without metformin were included. At the 1st interval; patients continued on their usual insulin regimen as twice or thrice daily injections with adjustment of insulin doses guided by their glucose readings. On the 2nd interval; patients were switched to the other regimen with the same total daily insulin dose redistributed.
RESULTS
There was a significant decrease in HbA1c level (p < 0.05) at the end of the first 3 months of trial regardless on which regimen the patient started, but there was no significant difference in the mean HbA1c reduction in patients when they were on twice daily insulin injections (1.1 ± 1.3) versus the time they were on thrice daily insulin injections (0.8 ± 1.71), p > 0.05. On the other hand, patients had lower average blood glucose readings (mg/dl) when they were on thrice daily insulin injections (161.4 ± 62.7) compared to twice daily regimen (166.0 ± 69.5), p < 0.05.",2020,"There was a significant decrease in HbA1c level (p < 0.05) at the end of the first 3 months of trial regardless on which regimen the patient started, but there was no significant difference in the mean HbA1c reduction in patients when they were on twice daily insulin injections (1.1 ± 1.3) versus the time they were on thrice daily insulin injections (0.8 ± 1.71), p > 0.05.","['type 2 diabetes mellitus (T2DM) patients', 'Twenty-two diabetic patients who were already using BHI 30 in twice or thrice daily regimens with or without metformin were included']",['thrice daily Biphasic Human Insulin 30 (BHI 30) versus the traditional twice-daily regimen'],"['efficacy and safety', 'average blood glucose readings', 'HbA1c level', 'mean HbA1c reduction']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C3501748', 'cui_str': 'biphasic human insulin 30'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3501748', 'cui_str': 'biphasic human insulin 30'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",22.0,0.0189197,"There was a significant decrease in HbA1c level (p < 0.05) at the end of the first 3 months of trial regardless on which regimen the patient started, but there was no significant difference in the mean HbA1c reduction in patients when they were on twice daily insulin injections (1.1 ± 1.3) versus the time they were on thrice daily insulin injections (0.8 ± 1.71), p > 0.05.","[{'ForeName': 'Nesreen A', 'Initials': 'NA', 'LastName': 'Saadeh', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Jordan University of Science and Technology, P.O.Box 3030, Irbid, 22110, Jordan. nasaadeh@just.edu.jo.'}, {'ForeName': 'Ola Y', 'Initials': 'OY', 'LastName': 'Al-Azzeh', 'Affiliation': 'Pharmacy Practice Department, College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Yousef S', 'Initials': 'YS', 'LastName': 'Khader', 'Affiliation': 'Department of Community Medicine, Public Health and Family Medicine, Faculty of Medicine, Jordan University of Science & Technology, Irbid, Jordan.'}]",BMC research notes,['10.1186/s13104-020-05090-6']
2951,32448384,Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study.,"BACKGROUND
Iliotibial band syndrome (ITBS) carries marked morbidity in runners. Its management is not standardized and lacks evidence base. We evaluated the effectiveness of three different exercises programs in reducing ITBS symptoms.
METHODS
Patients were divided into three equal treatment groups: ITB stretching (group A), conventional exercise (group B), and experimental hip strengthening exercise (group C). Numeric pain rating scale (NPRS; every week), lower extremity functional scale (LEFS; every 2 weeks), dynamometer (DN; weeks 0, 2, 4, 6, 8), single-limb mini squat (SLMS; week 0, 8), and Y-balance test™ (YBT), between and within group's differences were evaluated using ANOVA model.
RESULTS
Twenty-four female runners (age 19-45 years) were included into one of three groups (A, B, and C). Statistical significance (p < 0.05) within group C was observed for composite YBT and DN for injured and non-injured leg, the YBT (injured leg for the posterior medial), LEFS, NPRS, and the SLMS. Statistical significance (p < 0.05) was found between group A and group C. The stretching group exhibited statistically significant (p < 0.05) YBT anterior reach for the injured/non-injured leg and the LEFS.
CONCLUSION
There were no statistical differences between the three groups. The subjects who underwent experimental hip strengthening exercises consistently showed improvements in outcome measures, and never scored less than the other two groups.
TRIAL REGISTRATION
ClinicalTrials.gov identifier (NCT number): NCT0229615.",2020,"The stretching group exhibited statistically significant (p < 0.05) YBT anterior reach for the injured/non-injured leg and the LEFS.
","['runners', 'Twenty-four female runners (age 19-45 years', 'Patients', 'female runners']","['ITB stretching', 'Iliotibial band syndrome rehabilitation', 'conventional exercise (group B), and experimental hip strengthening exercise', 'experimental hip strengthening exercises']","['ITBS symptoms', 'Numeric pain rating scale (NPRS; every week), lower extremity functional scale (LEFS; every 2 weeks), dynamometer (DN; weeks 0, 2, 4, 6, 8), single-limb mini squat (SLMS; week 0, 8), and Y-balance test™ (YBT']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0263843', 'cui_str': 'Snapping hip'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0263843', 'cui_str': 'Snapping hip'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0207973,"The stretching group exhibited statistically significant (p < 0.05) YBT anterior reach for the injured/non-injured leg and the LEFS.
","[{'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'McKay', 'Affiliation': 'Emirates Integra Medical and Surgery Centre, Dubai, UAE.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Department of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, Salerno, Italy. n.maffulli@qmul.ac.uk.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Aicale', 'Affiliation': 'Department of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, Salerno, Italy.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Taunton', 'Affiliation': 'Allan McGavin Sports Medicine Centre, Vancouver, BC, Canada.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01713-7']
2952,32448387,The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial.,"BACKGROUND
Chronic pain is highly prevalent in the working population. People tend to attempt self-initiated treatments to manage their pain. The self-efficacy of behavioural change is a suitable model for guiding the development of an electronic pain management programme (ePain). The aim in this study is to develop ePain and to evaluate its effectiveness at improving pain self-efficacy, reducing pain intensity and negative emotions, and increasing quality of life.
METHODS
This study will be a randomized controlled trial. ePain will take the form of a 6-week online pain management programme. Participants will be aged 15 years or above, have chronic pain, and be employed. They must complete the baseline questionnaire and will be randomized into intervention and control groups. They will receive notifications to encourage their participation in ePain and complete the evaluation questionnaires. They will complete the process evaluation at week 3, the post assessment at week 6, and the follow-up assessment at week 12. The study will focus on pain self-efficacy; pain situations; negative emotions including levels of depression, anxiety, and stress; and quality of life. The participants' opinions of ePain will be collected as feedback. Data will be analysed on an intention-to-treat basis and generalized estimating equations will be used to investigate the time-averaged difference and differences at each follow-up time.
DISCUSSION
The study will provide information about the pain situations of online users in the working population. The participants will benefit from improvements in pain self-efficacy, pain situations, emotional status, and quality of life. The study will illustrate whether online learning is an effective intervention for improving the pain self-efficacy of the working population.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03718702. Registered on 23 October 2018.",2020,The self-efficacy of behavioural change is a suitable model for guiding the development of an electronic pain management programme (ePain).,"['working population with chronic pain', 'Participants will be aged 15\xa0years or above, have chronic pain, and be employed']","['electronic pain management programme', 'online learning']","['quality of life', 'pain self-efficacy, pain situations, emotional status, and quality of life', 'pain self-efficacy, reducing pain intensity and negative emotions', 'pain self-efficacy', 'depression, anxiety, and stress; and quality of life']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.151,The self-efficacy of behavioural change is a suitable model for guiding the development of an electronic pain management programme (ePain).,"[{'ForeName': 'Shuk Kwan', 'Initials': 'SK', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong. skangel.tang@connect.polyu.hk.'}, {'ForeName': 'Mimi Mun Yee', 'Initials': 'MMY', 'LastName': 'Tse', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Sau Fong', 'Initials': 'SF', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Theofanis', 'Initials': 'T', 'LastName': 'Fotis', 'Affiliation': 'School of Health Sciences, University of Brighton, Westlain House, Village Way, Brighton, BN1 9PH, UK.'}]",Trials,['10.1186/s13063-020-04348-5']
2953,32462740,Vitamin D supplementation for sickle cell disease.,"BACKGROUND
Sickle cell disease (SCD) is a genetic chronic haemolytic and pro-inflammatory disorder. With increased catabolism and deficits in energy and nutrient intake, individuals with SCD suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency. This is an update of a previous review.
OBJECTIVES
To investigate the effects of vitamin D supplementation in children and adults with SCD and to compare different dose regimens. To determine the effects of vitamin D supplementation on general health (e.g. growth status and health-related quality of life), on musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections) and the safety of vitamin D supplementation.
SEARCH METHODS
We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 19 March 2020. We also searched database such as PubMed, clinical trial registries and the reference lists of relevant articles and reviews. Date of last search: 14 January 2020.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-RCTs comparing oral administration of any form of vitamin D supplementation at any dose and for any duration to another type or dose of vitamin D or placebo or no supplementation in people with SCD, of all ages, gender, and phenotypes.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted the data and assessed the risk of bias of the included studies. They used the GRADE guidelines to assess the quality of the evidence.
MAIN RESULTS
Vitamin D versus placebo One double-blind RCT (n = 39) compared oral vitamin D3 (cholecalciferol) supplementation (20 participants) to placebo (19 participants) for six weeks. Only 25 participants completed the full six months of follow-up. The study had a high risk of bias due to incomplete outcome data, but a low risk of bias for randomisation, allocation concealment, blinding (of participants, personnel and outcome assessors) and selective outcome reporting; and an unclear risk of other biases. Vitamin D supplementation probably led to higher serum 25(OH)D levels at eight weeks, mean difference (MD) 29.79 (95% confidence interval (CI) 26.63 to 32.95); at 16 weeks, MD 12.67 (95% CI 10.43 to 14.90); and at 24 weeks, MD 15.52 (95% CI 13.50 to 17.54) (moderate-quality evidence). There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence). Vitamin D supplementation probably caused fewer pain days compared to the placebo group at eight weeks, MD -10.00 (95% CI -16.47 to -3.53) (low-quality evidence), but probably led to a lower (worse) health-related quality of life score (change from baseline in physical functioning PedsQL scores); at both 16 weeks, MD -12.56 (95% CI -16.44 to -8.69) and 24 weeks, MD -12.59 (95% CI -17.43 to -7.76), although this may not be the case at eight weeks (low-quality evidence). Vitamin D supplementation regimens compared Two double-blind RCTs (83 participants) compared different regimens of vitamin D. One RCT (n = 62) compared oral vitamin D3 7000 IU/day to 4000 IU/day for 12 weeks, while the second RCT (n = 21) compared oral vitamin D3 100,000 IU/month to 12,000 IU/month for 24 months. Both RCTs had low risk of bias for blinding (of participants, personnel and outcome assessors) and incomplete outcome data, but the risk of selective outcome reporting bias was high. The bias from randomisation and allocation concealment was low in one study but not in the second. There was an unclear risk of other biases. When comparing oral vitamin D 100,000 IU/month to 12,000 IU/month, the higher dose may have resulted in higher serum 25(OH)D levels at one year, MD 16.40 (95% CI 12.59 to 20.21) and at two years, MD 18.96 (95% CI 15.20 to 22.72) (low-quality evidence). There was little or no difference in adverse events between doses (low-quality evidence). There were more episodes of acute chest syndrome in the high-dose group, at one year, MD 0.27 (95% CI 0.02 to 0.52) but there was little or no difference at two years, MD 0.09 (95% CI -0.04 to 0.22) (moderate-quality evidence). At one year and two years there was also little or no difference between the doses in the presence of pain (moderate-quality evidence) or forced expiratory volume in one second % predicted. However, the high-dose group had lower values for % predicted forced vital capacity at both one and two years, MD -7.20% predicted (95% CI -14.15 to -0.25) and MD -7.10% predicted (95% CI -14.03 to -0.17), respectively. There were little or no differences between dose regimens in the muscle health of either hand or the dominant hand. The study comparing oral vitamin D3 7000 IU/day to 4000 IU/day (21 participants) did not provide data for analysis, but median serum 25(OH)D levels were reported to be lower in the low-dose group at both six and 12 weeks. At 12 weeks the median serum parathyroid hormone level was lower in the high-dose group.
AUTHORS' CONCLUSIONS
We included three RCTs of varying quality. We consider that the current evidence presented in this review is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation and dietary reference intakes for calcium and vitamin D. Well-designed RCTs of parallel design, are required to determine the effects and the safety of vitamin D supplementation as well as to assess the relative benefits of different doses in children and adults with SCD.",2020,"There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence).","['sickle cell disease', 'children and adults with SCD', 'people with SCD, of all ages, gender, and phenotypes']","['vitamin D. One RCT', 'vitamin D or placebo or no supplementation', 'Vitamin D supplementation', 'oral vitamin D3', 'vitamin D supplementation', 'oral vitamin D3 (cholecalciferol) supplementation', 'placebo']","['general health (e.g. growth status and health-related quality of life', 'musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections', 'forced vital capacity', 'pain days', 'episodes of acute chest syndrome', 'presence of pain (moderate-quality evidence) or forced expiratory volume', 'adverse events (tingling of lips or hands', 'lower (worse) health-related quality of life score', 'adverse events', 'median serum parathyroid hormone level', 'median serum 25(OH)D levels', 'serum 25(OH)D levels']","[{'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0231225', 'cui_str': 'Pain crisis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0742343', 'cui_str': 'Acute chest syndrome'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0877487', 'cui_str': 'Tingling lips'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.658415,"There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence).","[{'ForeName': 'Htoo Htoo Kyaw', 'Initials': 'HHK', 'LastName': 'Soe', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Melaka-Manipal Medical College, Manipal Academy of Higher Education (MAHE), Melaka, Malaysia.'}, {'ForeName': 'Adinegara Bl', 'Initials': 'AB', 'LastName': 'Abas', 'Affiliation': 'Department of Community Medicine, Melaka-Manipal Medical College (Manipal Academy of Higher Education), Melaka, Malaysia.'}, {'ForeName': 'Nan Nitra', 'Initials': 'NN', 'LastName': 'Than', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Melaka-Manipal Medical College (MMMC), Manipal Academy of Higher Education(MAHE), Melaka, Malaysia.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Faculty of Medicine, SEGi University, Sibu, Malaysia.'}, {'ForeName': 'Jaspal', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Faculty of Medicine, Melaka-Manipal Medical College, Melaka, Malaysia.'}, {'ForeName': 'Abdul Razzak Bin Mohd', 'Initials': 'ARBM', 'LastName': 'Said', 'Affiliation': 'Melaka-Manipal Medical College, Melaka, Malaysia.'}, {'ForeName': 'Ifeyinwa', 'Initials': 'I', 'LastName': 'Osunkwo', 'Affiliation': 'Comprehensive Sickle Cell Program, Aflac Cancer and Blood Disorders Service, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010858.pub3']
2954,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES
Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome.
METHODS
Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention.
RESULTS
Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself.
LIMITATIONS
The mean level of procrastination in this study was lower than in other treatment studies of procrastination.
CONCLUSIONS
Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579']
2955,32442195,Antibody and cellular responses to HIV vaccine regimens with DNA plasmid as compared with ALVAC priming: An analysis of two randomized controlled trials.,"BACKGROUND
DNA plasmids promise a pragmatic alternative to viral vectors for prime-boost HIV-1 vaccines. We evaluated DNA plasmid versus canarypox virus (ALVAC) primes in 2 randomized, double-blind, placebo-controlled trials in southern Africa with harmonized trial designs. HIV Vaccine Trials Network (HVTN) 111 tested DNA plasmid prime by needle or needleless injection device (Biojector) and DNA plasmid plus gp120 protein plus MF59 adjuvant boost. HVTN 100 tested ALVAC prime and ALVAC plus gp120 protein plus MF59 adjuvant boost (same protein/adjuvant as HVTN 111) by needle.
METHODS AND FINDINGS
The primary endpoints for this analysis were binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96) at month 6.5, two weeks after the fourth vaccination. Per-protocol cohorts included vaccine recipients from HVTN 100 (n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017. IgG bAb response rates were 100% to 3 Env gp120 antigens in both trials. Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001). Among positive responders, bAb net mean fluorescence intensity (MFI) was significantly higher with the DNA-primed regimen than ALVAC-primed for 1086 V1V2 (geometric mean [GM] 2,833.3 versus 1,200.9; ratio = 2.36, 95% CI 1.42-3.92, p < 0.001) and B.CaseA V1V2 (GM 2314.0 versus 744.6, ratio = 3.11, 95% CI 1.51-6.38, p = 0.002). nAb response rates were >98% in both trials, with significantly higher 50% inhibitory dilution (ID50) among DNA-primed positive responders (n = 53) versus ALVAC-primed (n = 182) to tier 1A MW965.26 (GM 577.7 versus 265.7, ratio = 2.17, 95% CI 1.67-2.83, p < 0.001) and to TV1c8.2 (GM 187.3 versus 100.4, ratio = 1.87, 95% CI 1.48-2.35, p < 0.001). CD4+ T-cell response rates were significantly higher with DNA plasmid prime via Biojector than ALVAC prime (91.4% versus 52.8%, difference = 38.6%, 95% CI 20.5%-56.6%, p < 0.001 for ZM96.C; 88.0% versus 43.1%, difference = 44.9%, 95% CI 26.7%-63.1%, p < 0.001 for 1086.C; 55.5% versus 2.2%, difference = 53.3%, 95% CI 23.9%-82.7%, p < 0.001 for Gag LAI/ZM96). The study's main limitations include the nonrandomized comparison of vaccines from 2 different trials, the lack of data on immune responses to other non-vaccine-matched antigens, and the uncertain clinical significance of the observed immunological effects.
CONCLUSIONS
In this study, we found that further investigation of DNA/protein regimens is warranted given enhanced immunogenicity to the V1V2 correlates of decreased HIV-1 acquisition risk identified in RV144, the only HIV vaccine trial to date to show any efficacy.",2020,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","['Per-protocol cohorts included vaccine recipients from HVTN 100', 'southern Africa with harmonized trial designs', 'n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017']","['placebo', 'ALVAC priming', 'DNA plasmid versus canarypox virus (ALVAC']","['IgG bAb response rates', 'nAb response rates', 'Response rates to V1V2', 'binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96', 'bAb net mean fluorescence intensity (MFI', 'CD4+ T-cell response rates']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0211671', 'cui_str': 'ALVAC vaccine'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0282472', 'cui_str': 'Canarypox virus'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0019686', 'cui_str': 'AIDS Antigens'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.585483,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Maganga', 'Affiliation': 'NIMR-Mbeya Medical Research Center, Mbeya, Tanzania.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Herce', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Naidoo', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'Aurum Institute, Klerksdorp, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'deCamp', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Heptinstall', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Dintwe', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, University of Regensberg, Regensberg, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Swiss Vaccine Research Institute, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Andersen-Nissen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003117']
2956,32442198,No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya.,"BACKGROUND
Attention has recently turned toward the use of device-assisted male circumcision to help scale up male circumcision services in sub-Saharan Africa, with increasing emphasis on younger age groups. We assessed the use of the ShangRing for circumcising the subset of boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya.
METHODS
We performed a sub-analysis of outcomes in 197 boys aged 10 to 12 years; a subset who were enrolled in two randomized clinical trials to assess the use of the no-flip ShangRing circumcision technique in men and boys. One trial assessed spontaneous detachment vs. planned removal of the ShangRing 7 days post-circumcision. The second trial compared the use of topical vs. injectable anesthesia with ShangRing circumcision. Aside from baseline characteristics, data was collected and analyzed for each trial separately.
RESULTS
All participants were successfully circumcised. Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction were similar between the two groups in each trial. Mean time required for spontaneous ShangRing detachment was 14.82±3.76 days. Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001). Median dwell time of the topical anesthetic was 43 (IQR: 35.5-60) minutes, while the median time it took the injectable anesthetic to take effect was 2.04 (IQR: 1.72-3.09) minutes.
CONCLUSION
No-flip ShangRing circumcision had a positive safety profile among young adolescent boys, specifically ages 10-12 years. The use of spontaneous device detachment and topical anesthesia with the procedure have shown promising outcomes in this age group. This may have the potential to further increase the acceptability of ShangRing circumcision, and therefore accelerate the scle up of male circumcision services in sub-Saharan Africa.
TRIAL REGISTRATION
ClinicalTrials.gov registration # NCT02390310.",2020,"Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001).","['boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya', 'young adolescent boys, specifically ages 10-12 years', '10-12 year old boys', '197 boys aged 10 to 12 years', 'in men and boys']","['topical vs. injectable anesthesia with ShangRing circumcision', 'no-flip ShangRing circumcision technique', 'Topical anesthesia']","['Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction', 'Median dwell time of the topical anesthetic', 'positive safety profile', 'mean pain score', 'Mean time required for spontaneous ShangRing detachment']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}]",197.0,0.304241,"Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001).","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Al Hussein Alawamlh', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Quentin D', 'Initials': 'QD', 'LastName': 'Awori', 'Affiliation': 'EngenderHealth, Nairobi, Kenya.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Barone', 'Affiliation': 'EngenderHealth, Washington, DC, NY, United States of America.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Li', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}]",PloS one,['10.1371/journal.pone.0233150']
2957,32442205,No effect of repetitive tDCS on daily smoking behaviour in light smokers: A placebo controlled EMA study.,"INTRODUCTION
The effectiveness of repetitive transcranial Direct Current Stimulation (tDCS) on reducing smoking behaviour has been studied with mixed results. Smoking behaviour is influenced by affect and context, therefore we choose to use mobile ecological momentary assessments (EMA) to measure changes in smoking behaviour after tDCS.
METHODS
In a randomized, placebo-controlled, between subject study, we applied tDCS bilaterally with the anodal electrode targeting the right DLPFC (https://clinicaltrials.gov/ct2/show/NCT03027687). Smokers were allocated to six sessions of either active tDCS (n = 35) or sham tDCS (n = 36) and received two sessions on three different days in one week. They were asked to keep track of their daily cigarette consumption, craving and affect in an application on their mobile phones for three months starting one week before the first tDCS session.
RESULTS
Number of smoked cigarettes a day progressively decreased up to one week after the last tDCS session in both conditions. Active treatment had no additional effect on cigarette consumption, craving and affect.
CONCLUSIONS
In this exploratory study, repetitive bilateral tDCS over the DLPFC had no effect on daily smoking behaviour. Future research needs to investigate how motivation to quit smoking and the number of tDCS sessions affect the efficacy of repetitive tDCS.",2020,"Active treatment had no additional effect on cigarette consumption, craving and affect.
",['light smokers'],"['repetitive transcranial Direct Current Stimulation (tDCS', 'sham tDCS', 'active tDCS', 'repetitive tDCS', 'placebo']","['daily smoking behaviour', 'cigarette consumption, craving and affect']","[{'cui': 'C3494624', 'cui_str': 'Light tobacco smoker'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0277547,"Active treatment had no additional effect on cigarette consumption, craving and affect.
","[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Jongerling', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0233414']
2958,32442688,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - An open labeled, randomized controlled trial"" - What is missing for a careful analysis? The importance of considering all the factors involved.",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.102212,,"[{'ForeName': 'Leandro Ryuchi', 'Initials': 'LR', 'LastName': 'Iuamoto', 'Affiliation': 'Department of Surgery, Laboratory of Medical Research 02, Division of Human Structural Topography, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'General and Gastrointestinal (GI) Surgeon, Hospital Das Clínicas, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil. Electronic address: alberto.meyer@usp.br.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.045']
2959,32443348,Adductor canal block with periarticular infiltration versus periarticular infiltration alone after total knee arthroplasty: A randomized controlled trial protocol.,"BACKGROUND
Effective postoperative analgesia may enhance early rehabilitation after total knee arthroplasty (TKA). The purpose of this study is to perform a randomized controlled trial to compare the efficiency of adductor canal block (ACB) with periarticular infiltration (PAI) versus PAI alone for early postoperative pain treatment after TKA.
METHODS
After institutional review board approval, written informed consent was obtained from patients undergoing elective TKA. Subjects were randomized into 2 groups as follows: adductor canal blockade with 30 mL of 0.5% ropivacaine and 100 mcg of clonidine. All patients received a periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics postoperatively for breakthrough pain. The primary outcome was morphine consumption in the first 24 hours. Secondary outcomes included pain scores, morphine consumption at 48 hours, opioid-related side effects (post-operative nausea/vomiting, sedation scores), functional outcomes, quadriceps strength, and length of hospital stay.
CONCLUSIONS
For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
TRIAL REGISTRATION NUMBER
researchregistry5490.",2020,"For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
","['total knee arthroplasty (TKA', 'after total knee arthroplasty', 'patients undergoing elective TKA', 'early postoperative pain treatment after TKA']","['clonidine', 'periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics', 'Adductor canal block with periarticular infiltration versus periarticular infiltration alone', 'adductor canal block (ACB) with periarticular infiltration (PAI) versus PAI alone', 'adductor canal blockade with 30\u200amL of 0.5% ropivacaine']","['morphine consumption', 'pain scores, morphine consumption at 48\u200ahours, opioid-related side effects (post-operative nausea/vomiting, sedation scores), functional outcomes, quadriceps strength, and length of hospital stay', 'morphine consumption and pain scores']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332153', 'cui_str': 'Requested by patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.331919,"For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
","[{'ForeName': 'Yongcheng', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jiacai', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology and Otorhinolaryngology, Qianjiang District Chinese medicine hospital of Chongqing, Chongqing, China.'}]",Medicine,['10.1097/MD.0000000000020213']
2960,32443977,"The evaluation of Suchana, a large-scale development program to prevent chronic undernutrition in north-eastern Bangladesh.","Evidence of the impact of community-based nutrition programs is uncommon for two main reasons: the lack of untreated controls, and implementation does not account for the evaluation design. Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households. Suchana is being implemented in 157 unions, the smallest administrative unit of government, in two districts of Sylhet. Suchana will deliver a package of interventions to poor people in about 40 randomly selected new unions annually over 4 years, until all are covered. All beneficiaries will receive the normal government nutrition services. For evaluation purposes the last 40 unions will act as a control for the first 40 intervention unions. The remaining unions will receive the program but will not take part in the evaluation. A baseline survey was conducted in both intervention and control unions; it will be repeated after 3 years to estimate the impact on the prevalence of stunted children and other indicators. This stepped wedge design has several advantages for both the implementation and evaluation of services, as well as some disadvantages. The units of delivery are randomized, which controls for other influences on outcomes; the program supports government service delivery systems, so it is replicable and scalable; and the program can be improved over time as lessons are learned. The main disadvantages are the difficulty of estimating the impact of each component of the program, and the geographical distribution of unions, which increases program delivery costs. Stepped implementation allows a cluster randomized trial to be achieved within a large-scale poverty alleviation program and phased-in and scaled-up over a period of time. This paper may encourage evaluators to consider how to estimate attributable impact by using stepped implementation, which allows the counterfactual group eventually to be treated.",2020,"Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households.","['chronic undernutrition in north-eastern Bangladesh', '157 unions, the smallest administrative unit of government, in two districts of Sylhet']",['community-based nutrition programs'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018104', 'cui_str': 'Government'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0221132,"Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households.","[{'ForeName': 'Nuzhat', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. nuzhat@icddrb.org.'}, {'ForeName': 'Mohammad Jyoti', 'Initials': 'MJ', 'LastName': 'Raihan', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'S M Tanvir', 'Initials': 'SMT', 'LastName': 'Ahmed', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Kazi Eliza', 'Initials': 'KE', 'LastName': 'Islam', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Self', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Shahed', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh.'}]",BMC public health,['10.1186/s12889-020-08769-4']
2961,32443981,"Study protocol: improving cognition in people with progressive multiple sclerosis: a multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx).","BACKGROUND
Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people with progressive forms of the disease who have objectively identified cognitive impairment. It is hypothesized that CR and EX are effective treatments for people with PMS who have cognitive impairment, in particular processing speed (PS) deficits, and that a combination of these two treatments is more effective than each individual treatment given alone. We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
METHODS
This study is a multisite, randomized, double-blinded, sham controlled clinical trial of CR and aerobic exercise. Three hundred and sixty subjects from 11 sites will be randomly assigned into one of four groups: CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise. Subjects will participate in the assigned treatments for 12 weeks, twice a week. All subjects will have a cognitive and physical assessment at baseline, 12 weeks and 24 weeks. In an embedded sub-study, approximately 30% of subjects will undergo structural and functional MRI to investigate the neural mechanisms underlying the behavioral response. The primary outcome is the Symbol Digit Modalities Test (SDMT) measuring PS. Secondary outcome measures include: indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI.
DISCUSSION
The study is being undertaken in 6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages. The rationale for this approach is to obtain a robustly powered sample size and to demonstrate that these two interventions can be given effectively in multiple countries and in different languages.
TRIAL REGISTRATION
The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.",2020,"We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
","['people with progressive MS (PMS', 'people with progressive multiple sclerosis', 'Three hundred and sixty subjects from 11 sites', 'people with PMS who have cognitive impairment', '6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages', 'people with relapsing-remitting MS without cognitive impairment', 'people with progressive forms of the disease who have objectively identified cognitive impairment']","['cognitive rehabilitation and aerobic exercise (COGEx', 'cognitive rehabilitation (CR) and aerobic exercise (EX', 'CR and aerobic exercise', 'CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise']","[' indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI', 'Symbol Digit Modalities Test (SDMT) measuring PS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]",,0.510419,"We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Amato', 'Affiliation': 'Department NEUROFARBA, Section Neurosciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Brichetto', 'Affiliation': 'Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Via Operai 40, 16149, Genoa, Italy.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Queen Square MS Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Section for Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, DK-8000, Aarhus, Denmark. dalgas@ph.au.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, and Neurology unit, IRCCS, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health: Medicine, Dentistry and Human Sciences, University of Plymouth, Devon, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Inglese', 'Affiliation': 'Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), and Center of Excellence for Biomedical Research, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Maria Assunta', 'Initials': 'MA', 'LastName': 'Rocca', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, and Neurology unit, IRCCS, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC neurology,['10.1186/s12883-020-01772-7']
2962,32444433,"Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS).","INTRODUCTION
Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.
METHODS AND ANALYSIS
Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.
ETHICS AND DISSEMINATION
NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.
TRIAL REGISTRATION NUMBER
ISRCTN17825590.",2020,"A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use.","['56 participants', 'Subacromial spacer for Tears Affecting Rotator cuff Tendons', 'Tears Affecting Rotator cuff Tendons', '221 participants', 'people with a symptomatic irreparable rotator cuff tear', 'individuals undergoing arthroscopic debridement for irreparable rotator cuff tears']","['subacromial balloon spacer', 'arthroscopic debridement with the InSpace balloon (Stryker, USA', 'deltoid-active MRI scans', 'arthroscopic debridement alone', 'Subacromial spacer']",['Oxford Shoulder Score'],"[{'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}]",221.0,0.251892,"A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Metcalfe', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK A.Metcalfe@warwick.ac.uk.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Gemperle Mannion', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': 'Patient Representative, Durham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kearney', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Lawrence', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Bush', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'McGowan', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hutchinson', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Drew', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036829']
2963,32445975,Wii training versus non-Wii task-specific training on motor learning in children with developmental coordination disorder: A randomized controlled trial.,"BACKGROUND
Wii-based interventions have shown significant benefits in motor learning for children with developmental coordination disorder (DCD); however, studies comparing the effects of Wii interventions versus matched non-Wii interventions, such as task-specific training (TST), are scarce.
OBJECTIVE
We compared motor learning in children with DCD who participated in 12 sessions of Wii-based training and those participating in 12 closely matched non-Wii TST sessions as well as when the highest improvements in performance occurred.
METHODS
In total, 32 children with DCD (16 per group) were randomly allocated to receive the Wii intervention or TST during 12 sessions. Motor learning was assessed in 3 consecutive phases during the intervention and was determined by the mean of the games scores obtained in the: (1) first 4 sessions, (2) intermediate 4 sessions, and (3) last 4 sessions. Six different tasks (table tennis, frisbee, archery, bowling, tightrope walking/balance beam, and marble balance/balance disc) were performed in every session. Each session lasted 42min (time on task).
RESULTS
Wii training and TST elicited improvements in motor learning, as assessed by increased scores with the frisbee and marble balance/balance disc tasks. However, Wii training elicited better performance in the archery and bowling tasks, whereas only TST elicited improvements in the balance beam and table tennis tasks.
CONCLUSION
Wii training is not always superior to non-Wii training, and improvements are based on the type of task trained. Thus, each type of intervention benefits a certain skill.",2020,"Wii training is not always superior to non-Wii training, and improvements are based on the type of task trained.","['children with developmental coordination disorder (DCD', 'children with DCD who participated in 12 sessions of Wii-based training and those participating in 12 closely matched non', 'children with developmental coordination disorder', '32 children with DCD (16 per group']","['Wii training versus non-Wii task-specific training', 'motor learning', 'Wii training', 'Wii TST sessions', 'Wii intervention or TST']","['scores with the frisbee and marble balance/balance disc tasks', 'motor learning', 'Motor learning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205689', 'cui_str': 'Marble'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",32.0,0.0193506,"Wii training is not always superior to non-Wii training, and improvements are based on the type of task trained.","[{'ForeName': 'Jorge Lopes', 'Initials': 'JL', 'LastName': 'Cavalcante Neto', 'Affiliation': 'Department of physical therapy, universidade Federal de São Carlos, São Carlos, São Paulo, Brazil; Department of human sciences, universidade do Estado da Bahia, Jacobina, Bahia, Brazil. Electronic address: jorgelcneto@hotmail.com.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Steenbergen', 'Affiliation': 'Departamento kinesiologia, universidad Católica del Maule, Talca, Maule, Chile.'}, {'ForeName': 'Antonio Roberto', 'Initials': 'AR', 'LastName': 'Zamunér', 'Affiliation': 'Behavioural Science Institute, Radboud university, Nijmegen, The Netherlands.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Tudella', 'Affiliation': 'Department of physical therapy, universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.013']
2964,32446108,Cortisol awakening response in PTSD treatment: Predictor or mechanism of change.,"PTSD is associated with abnormalities in hypothalamic-pituitary-adrenal (HPA) axis activity. This includes enhanced HPA axis negative feedback, attenuated cortisol awakening response, and attenuated cortisol response to personal trauma script. Whether HPA axis function predicts treatment response or treatment related symptom reduction in PTSD remains unclear. In addition, the relative effects of different treatment modalities (i.e., medication and psychotherapy) on HPA axis is unclear. To address this gap in knowledge, the PROGrESS study examined cortisol awakening response across treatment in Veterans with chronic PTSD randomized to receive Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM). Salivary cortisol awakening response (CAR) was assessed at baseline, mid-treatment (week 6 and 12), post-treatment (week 24) and follow-up (week 36 and 52). Among males at baseline, combat veterans with PTSD showed lower CAR Area Under the Curve Increase (AUCi; M = 3.15, SD = 9.57) than Combat controls (M = 7.63, SD = 9.07; p = .02), demonstrating combat veterans with PTSD have a less responsive system than combat controls. Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03). When controlling for PTSD severity, higher baseline CAR AUCi was related to attenuated reduction in PTSD and lower likelihood of high treatment response over treatment (z = -2.06, p = .04).",2020,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).",['Veterans with chronic PTSD'],"['Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM']","['lower CAR Area Under the Curve Increase (AUCi', 'enhanced HPA axis negative feedback, attenuated cortisol awakening response', 'cortisol awakening response', 'Salivary cortisol awakening response (CAR', 'Cortisol awakening response', 'Higher PTSD severity', 'CAR AUCi']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]","[{'cui': 'C0740379', 'cui_str': 'Cortisol decreased'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0100699,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Healthcare System, 1670 Clairmont Road, Decatur, GA, 30033, Georgia; Emory University School of Medicine, 12 Executive Park, 3rdFloor, Atlanta, GA, 30029, Georgia. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Rajaram', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Venners', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; National Center for PTSD, Dissemination and Training Division, 795 Willow Road, Menlo Park, CA 94025, United States.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'New York University Medical School, Department of Psychiatry, One Park Avenue 8thFloor, New York, NY 10016, United States; Massachusetts General Hospital, Department of Psychiatry, One Bowdoin Square, 6th Floor, Boston, MA 02114, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamner', 'Affiliation': 'Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC, 29401, United States; Medical University of South Carolina, Department of Psychiatry, 67 President Street, Charleston, SC 29425, United States.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States; Texas A&M Health Science Center, Department of Psychiatry and Behavioral Science, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104714']
2965,32446145,Thyroid hormones ratio is a major prognostic marker in advanced metastatic colorectal cancer: Results from the phase III randomised CORRECT trial.,"BACKGROUND
Free triiodothyronine (FT3)/free thyroxine (FT4) ratio is an index estimating the peripheral activity of thyroid hormones. In a previous experience, we identified a prognostic role for FT3/FT4 ratio in chemorefractory patients treated with regorafenib. Therefore, we planned this post hoc analysis of the phase III CORRECT trial of regorafenib versus placebo.
METHODS
Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the placebo arm) were evaluable for the present analyses, based on availability of FT3 and FT4 baseline values. Co-primary objectives were to explore the predictive role of FT3/FT4 ratio in patients treated with regorafenib compared with placebo and to validate the prognostic value of FT3/FT4 ratio in the CORRECT trial.
RESULTS
For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively. Hazard ratio (HR) for OS was 0.40 (p < 0.0001) when comparing intermediate versus low and 0.32 (p < 0.0001) when comparing high versus low FT3/FT4 ratio. In the placebo arm, median OS was 3.3, 5.6 and 7.7 months, in the three subgroups. HR for OS was 0.47 (p < 0.0001) when comparing intermediate versus low and 0.33 (p < 0.0001) when comparing high versus low. FT3/FT4 ratio retained its association with OS in the multivariate model in both arms.
CONCLUSIONS
While rejecting the predictive effect of baseline FT3/FT4 ratio, present data strengthen the prognostic role of the ratio, pave the way for direct clinical application, underline the need for a better biological understanding and suggest possible therapeutic implications for thyroid hormones.",2020,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","['Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the', 'advanced metastatic colorectal cancer']","['regorafenib', 'regorafenib versus placebo', 'Thyroid hormones ratio', 'triiodothyronine (FT3)/free thyroxine ', 'placebo']","['Hazard ratio (HR) for OS', 'median OS', 'median overall survival (OS', 'availability of FT3 and FT4 baseline values', 'FT3/FT4 ratio']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",760.0,0.121696,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pasqualetti', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dochy', 'Affiliation': 'Bayer Healthcare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Fassan', 'Affiliation': 'Department of Medicine (DIMED), Surgical Pathology & Cytopathology Unit, University of Padua, Padua, Italy.'}, {'ForeName': 'Pina', 'Initials': 'P', 'LastName': 'Ziranu', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Puzzoni', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Scartozzi', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Monzani', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. Electronic address: fotios.loupakis@iov.veneto.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.023']
2966,32446158,Efficacy of mobile app-based interactive cognitive behavioral therapy using a chatbot for panic disorder.,"BACKGROUND
Cognitive behavioral therapy (CBT) is a well-established treatment for panic disorder, but many fewer patients receive this treatment compared to medication-based therapy. Mobile app-based interactive CBT using a chatbot can increase patient access to CBT. We performed a preliminary study to determine whether short-term use of a newly developed chatbot is feasible and effective for relieving panic symptoms.
METHOD
Forty-one patients were randomly assigned to either a chatbot group (n = 21) or control group (n = 20) for a period of 4 weeks. The chatbot group was guided in the use of the chatbot application, while the control group was provided with a book on panic disorder.
MAIN RESULTS
The severity of panic disorder was significantly decreased in the chatbot group, but not in the control group. The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
DISCUSSION AND CONCLUSION
We found that mobile app-based interactive CBT using the chatbot was feasible and effective for reducing the severity of panic symptoms. Using this novel approach to provide CBT would allow clinicians to effect positive therapeutic outcomes with easy accessibility, interactivity, and self-management for patients with panic symptoms.",2020,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
","['panic disorder', 'patients with panic symptoms', 'Forty-one patients']","['mobile app-based interactive CBT', 'chatbot group (n\u202f=\u202f21) or control group', 'mobile app-based interactive cognitive behavioral therapy', 'Cognitive behavioral therapy (CBT', 'Mobile app-based interactive CBT']","['severity of panic symptoms', 'severity of panic disorder', 'control helplessness score', 'social phobia score']","[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",41.0,0.0195038,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
","[{'ForeName': 'Jooyoung', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sooah', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Jin', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: jaejkim@yonsei.ac.kr.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104171']
2967,32449678,Arterial stiffness and kidney disease progression in the systolic blood pressure intervention trial
.,"AIMS
Arterial stiffness increases with both advancing age and chronic kidney disease (CKD) and may contribute to kidney function decline, but evidence is inconsistent. We hypothesized that greater baseline arterial stiffness (assessed as pulse pressure (PP) and carotid-femoral pulse-wave velocity CFPWV)) was independently associated with kidney disease progression over the follow-up period (3.8 years) in the Systolic Blood Pressure Intervention Trial (SPRINT).
MATERIALS AND METHODS
8,815 SPRINT participants were included in the analysis of PP. 592 adults who participated in a SPRINT ancillary study that measured CFPWV were included in subgroup analyses. Cox proportional hazards analysis was used to examine the association between PP and time to kidney disease progression endpoints: (A) incident estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 in non-CKD participants at baseline; (B) 50% decline in eGFR, initiation of dialysis, or transplant in those with baseline CKD. Mixed model analyses examined the association of baseline PP/CFPWV with follow-up eGFR.
RESULTS AND CONCLUSION
Mean ± SD age was 68 ± 10 years, baseline PP was 62 ± 14 mmHg, and CFPWV was 10.8 ± 2.7 m/s. In the fully adjusted model, PP ≥ median was associated with an increased hazard of kidney disease progression endpoints (HR: 1.93 (1.43 - 2.61)). The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)). In fully adjusted models, higher baseline PP associated with eGFR decline (p < 0.0001 (all, CKD, non-CKD)), but baseline CFPWV did not. Among older adults at high risk for cardiovascular events, baseline PP was associated with kidney disease progression.
.",2020,The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)).,"['8,815 SPRINT participants were included in the analysis of PP', 'SD age was 68\xa0±\xa010 years, baseline PP was 62\xa0±', '592 adults who participated in a SPRINT ancillary study that measured CFPWV were included in subgroup analyses', 'older adults']",[],"['Mean\xa0±', 'Arterial stiffness and kidney disease progression', 'baseline arterial stiffness', 'glomerular filtration rate (eGFR', 'pulse pressure (PP) and carotid-femoral pulse-wave velocity CFPWV', 'hazard of kidney disease progression endpoints', 'eGFR decline', 'kidney disease progression']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",8815.0,0.068225,The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)).,"[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Nowak', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': ''}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': ''}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Glasser', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lash', 'Affiliation': ''}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Simmons', 'Affiliation': ''}, {'ForeName': 'Addison', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': ''}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': ''}]",Clinical nephrology,['10.5414/CN109982']
2968,32448015,"Effects of the model of human occupation-based home modifications on the time use, occupational participation and activity limitation in people with disabilities: a pilot randomized controlled trial.","Purpose: To compare the effect of intervention providing home modifications and assistive devices based on MOHO theory with home exercise on people with disability in time use, competence and values of occupational performance and activity limitations. Methods: Participants were 20 people with disabilities due to deficits in central nervous system. Eleven people in the experimental group partook in environmental modifications and assistive device intervention and nine people in the control partook in home exercise programmes. A total of eight sessions were progressed, one pre-test, six sessions of interventions and one post-test. Occupational Questionnaire (OQ) was used to evaluate one's time use. Occupational Self Assessment (OSA) was used to test the competence and values of one's everyday occupational performance. Activity Limitations Measure (ACTIVLIM) was used to assess the activity limitation of one's functional ability. Wilcoxon signed rank test was used to analyse the comparison of the pre-post of time use, competence and values of occupational performance, and activity limitations. Mann-Whitney U was used to compare between both groups. Results: Among the four occupational areas of OQ, the participation time in ADL significantly increased and rest significantly decreased in the experimental group ( p <.05). The competence of occupational performance also increased in the experimental group whereas the values of occupational performance increased in the control group ( p <.05). The activity limitation significantly decreased in control group ( p <.05) but not in the experimental group. Conclusions: Using the interaction between human and environment for environmental modification increased the time use in occupational participation and competence to perform occupation in people with disability. By applying MOHO theory to evaluate and modify one's home environment and activity performance, we could comprehend the life style of clients and suggest opportunities to actively participate in ADLs.Implications for rehabilitationUsing the interaction between human and environment for environmental modification increased the time use in occupational participation and competence to perform occupation in people with disability.By applying MOHO theory to evaluate and modify one's home environment, we could comprehend the life style of clients and suggest opportunities to actively participate in ADLs.Adapting MOHO theory to enhance activity participation will contribute to enhance the quality of occupational therapy services in community settings.",2020,The activity limitation significantly decreased in control group ( p <.05) but not in the experimental group.,"['people with disabilities', 'Eleven people in the experimental group partook in environmental modifications and assistive device intervention and nine people in the control partook in home exercise programmes', '20 people with disabilities due to deficits in central nervous system', 'people with disability']","['human occupation-based home modifications', 'Occupational Self Assessment (OSA', 'MOHO theory with home exercise']","['Occupational Questionnaire (OQ', 'competence of occupational performance', 'participation time in ADL', 'time use, occupational participation and activity limitation', 'people with disability in time use, competence and values of occupational performance and activity limitations', 'values of occupational performance', 'activity limitation']","[{'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0325748', 'cui_str': 'Porphyrio mantelli'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0243273,The activity limitation significantly decreased in control group ( p <.05) but not in the experimental group.,"[{'ForeName': 'Ye-Ji', 'Initials': 'YJ', 'LastName': 'Jo', 'Affiliation': 'Department of Occupational Therapy, Konyang University, Dae-jeon, Republic of Korea.'}, {'ForeName': 'Hee', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Konyang University, Dae-jeon, Republic of Korea.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2020.1768306']
2969,32460786,"Protocol for a matched-pair cluster control trial of ARCHES (Addressing Reproductive Coercion in Health Settings) among women and girls seeking contraceptive services from community-based clinics in Nairobi, Kenya.","BACKGROUND
Reproductive coercion (RC) and intimate partner violence (IPV) are prevalent forms of gender-based violence (GBV) associated with reduced female control over contraceptive use and subsequent unintended pregnancy. Although the World Health Organization has recommended the identification and support of GBV survivors within health services, few clinic-based models have been shown to reduce IPV or RC, particularly in low or middle-income countries (LMICs). To date, clinic-based GBV interventions have not been shown to reduce RC or unintended pregnancy in LMIC settings.
INTERVENTION
ARCHES (Addressing Reproductive Coercion in Health Settings) is a single-session, clinic-based model delivered within routine contraceptive counseling that has been demonstrated to reduce RC in the United States. ARCHES was adapted to the Kenyan context via a participatory process to reduce GBV and unintended pregnancy among women and girls seeking contraceptive services in this setting. Core elements of ARCHES include enhanced contraceptive counseling that addresses RC, opportunity for patient disclosure of RC and IPV (and subsequent warm referral to local services), and provision of a palm-sized educational booklet.
METHODS
A matched-pair cluster control trial is being conducted to assess whether the ARCHES intervention (treatment condition), as compared to standard-of-care contraceptive counseling (control condition), reduces RC and IPV, and improves contraceptive outcomes for woman and girls of reproductive age (15 to 49 years) seeking contraceptive services from community-based clinics in Nairobi, Kenya. All six clinics were assigned to intervention-control pairs based on similarities in patient volume and demographics, physical structure and neighborhood context. Survey data will be collected from patients immediately prior to their clinic visit (baseline, T1), immediately after their clinic visit (exit), and at 3- and 6-months post-visit (T2 and T3, respectively).
DISCUSSION
This study is the first to assess the efficacy of an adaptation of the ARCHES model to reduce GBV and improve reproductive health outside of the U.S., and one of only a small number of controlled trials to assess reductions in GBV associated with a clinic-based program in an LMIC context. Evidence from this trial will inform health system efforts to reduce GBV, and to enhance female contraceptive control and reproductive health in Kenya and globally.
TRIAL REGISTRATION
Registered May 23, 2018 - ClinicalTrials.gov, NCT03534401. Unique Protocol ID: 170084.",2020,"To date, clinic-based GBV interventions have not been shown to reduce RC or unintended pregnancy in LMIC settings.
","['women and girls seeking contraceptive services from community-based clinics in Nairobi, Kenya', 'woman and girls of reproductive age (15 to 49\u2009years) seeking contraceptive services from community-based clinics in Nairobi, Kenya']","['ARCHES\xa0intervention (treatment condition), as compared to standard-of-care contraceptive counseling (control\xa0condition']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1443484', 'cui_str': 'Contraception care education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],6.0,0.0689499,"To date, clinic-based GBV interventions have not been shown to reduce RC or unintended pregnancy in LMIC settings.
","[{'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Uysal', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA. juysal@ucsd.edu.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Carter', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Johns', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Boyce', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Liambila', 'Affiliation': 'Population Council, Avenue 5, 3rd Floor, Rose Avenue, Nairobi, Kenya.'}, {'ForeName': 'Chi-Chi', 'Initials': 'CC', 'LastName': 'Undie', 'Affiliation': 'Population Council, Avenue 5, 3rd Floor, Rose Avenue, Nairobi, Kenya.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Muketo', 'Affiliation': 'Family Health Options Kenya, Family Health Plaza, Mai Mahiu Rd, Nairobi, Kenya.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Adhiambo', 'Affiliation': 'Family Health Options Kenya, Family Health Plaza, Mai Mahiu Rd, Nairobi, Kenya.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'International Planned Parenthood Federation, 4 Newhams Row, London, SE1 3UZ, UK.'}, {'ForeName': 'Seri', 'Initials': 'S', 'LastName': 'Wendoh', 'Affiliation': 'International Planned Parenthood Federation, 4 Newhams Row, London, SE1 3UZ, UK.'}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Silverman', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}]",Reproductive health,['10.1186/s12978-020-00916-9']
2970,32460799,Testing the efficacy of a minimal-guidance online self-help intervention for alcohol misuse in Estonia: study protocol of a randomized controlled trial.,"BACKGROUND
Despite an initial steep decrease in alcohol misuse among Estonians through structural intervention means and the scaling up of alcohol counselling in the mid-2000's, most of the country's alcohol misuse indicators remain clearly higher than European averages. Consequently, an online self-help program was launched as part of an initial behavioral intervention initiative to foster progress in alcohol prevention on a population level.
METHODS
A two-arm randomized controlled trial (RCT) has been designed to compare the efficacy of a culturally-adapted minimal-guidance online self-help program, the 8-week ""Selge"" online program against a control condition that consists of a self-administered test of alcohol use and advice regarding usual treatment in Estonia. A target sample of 600 individuals will be recruited and randomly assigned to either condition. The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI). Participants in the control group will have access to the full treatment after they complete their final follow-up assessment. The primary outcome will be change in the Alcohol Use Disorders Identification Test (AUDIT) score between the 6-month follow-up and baseline assessments. Secondary outcomes will include the number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health. Assessments will be completed at baseline, at the end of treatment, and at 6 months follow-up. Data analysis will follow the intention-to-treat principle and employ (generalised) linear mixed models.
DISCUSSION
The ""Selge"" program is the first and only internet program for the intervention of alcohol misuse in Estonia. If proven effective, it will foster progress in the intervention of alcohol misuse in the Estonian population and be implemented as a standard program amidst the continuum of intervention and care.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN48753339 registered 04/06/2019 retrospectively.",2020,The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI).,"['600 individuals', 'alcohol misuse in Estonia']","['cognitive behavioural therapy (CBT) and motivational interviewing (MI', 'minimal-guidance online self-help intervention']","['number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health', 'change in the Alcohol Use Disorders Identification Test (AUDIT) score']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0014908', 'cui_str': 'Estonia'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",600.0,0.0620665,The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI).,"[{'ForeName': 'Esta', 'Initials': 'E', 'LastName': 'Kaal', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia. esta.kaal@tai.ee.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wenger', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Triin', 'Initials': 'T', 'LastName': 'Ülesoo', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Haug', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Keough', 'Affiliation': 'Department of Psychology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Noormets', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kilp', 'Affiliation': 'Estonian National Institute for Health Development, Tallinn, Estonia.'}]",BMC public health,['10.1186/s12889-020-08791-6']
2971,32461554,Colchicine's effects on metabolic and inflammatory molecules in adults with obesity and metabolic syndrome: results from a pilot randomized controlled trial.,"OBJECTIVE
Recent clinical trials have demonstrated that colchicine may have metabolic and cardiovascular and benefits in at-risk patients; however, the mechanisms through which colchicine may improve outcomes are still unclear. We sought to examine colchicine's effects on circulating inflammatory and metabolic molecules in adults with obesity and metabolic syndrome (MetS).
METHODS
Blood samples were collected pre- and post-intervention during a double-blind randomized controlled trial in which 40 adults with obesity and MetS were randomized to colchicine 0.6 mg or placebo twice-daily for 3 months. Serum samples were analyzed for 1305 circulating factors using the SomaScan Platform. The Benjamini-Hochberg procedure was used to adjust the false discovery rate (FDR) for multiple testing.
RESULTS
At baseline, age (48.0 ± 13.8 vs. 44.7 ± 10.3 years) and BMI (39.8 ± 6.4 vs. 41.8 ± 8.2 kg/m 2 ) were not different between groups. After controlling for the FDR, 34 molecules were significantly changed by colchicine. Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A). Conversely, relative to placebo, colchicine significantly increased concentrations of eight molecules including secreted factors associated with metabolism and anti-thrombosis.
CONCLUSIONS
In adults with obesity, colchicine significantly affected concentrations of proteins involved in the innate immune system, endothelial function and atherosclerosis, uncovering new mechanisms behind its cardiometabolic effects. Further research is warranted to investigate whether colchicine's IL-6 suppressive effects may be beneficial in COVID-19.",2020,"Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A).","['adults with obesity and metabolic syndrome', '40 adults with obesity and MetS', 'adults with obesity and metabolic syndrome (MetS', 'At baseline, age (48.0\u2009±\u200913.8 vs. 44.7\u2009±\u200910.3 years) and BMI (39.8\u2009±\u20096.4 vs. 41.8\u2009±\u20098.2\u2009kg/m 2 ']","['placebo, colchicine', 'Colchicine', 'colchicine', ""Colchicine's"", 'colchicine 0.6\u2009mg or placebo']","['concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin', 'metabolic and inflammatory molecules', 'circulating inflammatory and metabolic molecules', 'false discovery rate (FDR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517822', 'cui_str': '6.4'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0985108', 'cui_str': 'Colchicine 0.6 MG'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0205557', 'cui_str': 'False positive'}]",40.0,0.602228,"Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A).","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Demidowich', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA. ademido1@jh.edu.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Levine', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Apps', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Foo K', 'Initials': 'FK', 'LastName': 'Cheung', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Jinguo', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Fantoni', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Tushar P', 'Initials': 'TP', 'LastName': 'Patel', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}]",International journal of obesity (2005),['10.1038/s41366-020-0598-3']
2972,32467712,Moderate- to high intensity aerobic and resistance exercise reduces peripheral blood regulatory cell populations in older adults with rheumatoid arthritis.,"Objective
Exercise can improve immune health and is beneficial for physical function in patients with rheumatoid arthritis (RA), but the immunological mechanisms are largely unknown. We evaluated the effect of moderate- to high intensity exercise with person-centred guidance on cells of the immune system, with focus on regulatory cell populations, in older adults with RA.
Methods
Older adults (≥65 years) with RA were randomized to either 20-weeks of moderate - to high intensity aerobic and resistance exercise ( n = 24) or to an active control group performing home-based exercise of light intensity ( n = 25). Aerobic capacity, muscle strength, DAS28 and CRP were evaluated. Blood samples were collected at baseline and after 20 weeks. The frequency of immune cells defined as adaptive regulatory populations, CD4 + Foxp3 + CD25 + CD127- T regulatory cells (Tregs) and CD19 + CD24hiCD38hi B regulatory cells (Bregs) as well as HLA-DR-/lowCD33 + CD11b + myeloid derived suppressor cells (MDSCs), were assessed using flow cytometry.
Results
After 20 weeks of moderate- to high intensity exercise, aerobic capacity and muscle strength were significantly improved but there were no significant changes in Disease Activity Score 28 (DAS28) or CRP. The frequency of Tregs and Bregs decreased significantly in the intervention group, but not in the active control group. The exercise intervention had no effect on MDSCs. The reduction in regulatory T cells in the intervention group was most pronounced in the female patients.
Conclusion
Moderate- to high intensity exercise in older adults with RA led to a decreased proportion of Tregs and Bregs, but that was not associated with increased disease activity or increased inflammation.
Trial registration
Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study, NCT02397798. Registered at ClinicalTrials.gov March 19, 2015.",2020,"After 20 weeks of moderate- to high intensity exercise, aerobic capacity and muscle strength were significantly improved but there were no significant changes in Disease Activity Score 28 (DAS28) or CRP.","['female patients', 'older adults with RA', 'older adults with rheumatoid arthritis', 'Methods\n\n\nOlder adults (≥65\u2009years) with RA', 'patients with rheumatoid arthritis (RA', 'Elderly Patients']","['exercise intervention', 'moderate- to high intensity exercise with person-centred guidance', 'moderate - to high intensity aerobic and resistance exercise ( n \u2009=\u200924) or to an active control group performing home-based exercise of light intensity', 'Moderate- to high intensity aerobic and resistance exercise']","['Disease Activity Score 28 (DAS28) or CRP', 'frequency of immune cells defined as adaptive regulatory populations, CD4\u2009+\u2009Foxp3\u2009+\u2009CD25\u2009+\u2009CD127- T regulatory cells (Tregs) and CD19\u2009+\u2009CD24hiCD38hi B regulatory cells (Bregs', 'Blood samples', 'MDSCs', 'intensity exercise, aerobic capacity and muscle strength', 'regulatory T cells', 'frequency of Tregs and Bregs', 'Aerobic capacity, muscle strength, DAS28 and CRP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007507', 'cui_str': 'Lymphocyte antigen CD25'}, {'cui': 'C0083032', 'cui_str': 'Interleukin-7 receptor'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C3178914', 'cui_str': 'B-Cells, Regulatory'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4277543', 'cui_str': 'MDSCs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}]",,0.0340539,"After 20 weeks of moderate- to high intensity exercise, aerobic capacity and muscle strength were significantly improved but there were no significant changes in Disease Activity Score 28 (DAS28) or CRP.","[{'ForeName': 'Sofia E M', 'Initials': 'SEM', 'LastName': 'Andersson', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Lange', 'Affiliation': '2University of Gothenburg Centre for Person-Centred Care, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kucharski', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Svedlund', 'Affiliation': '4Department of Molecular and Clinical Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Önnheim', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bergquist', 'Affiliation': '5Department of Medical Sciences, Clinical Physiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Josefsson', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Lord', 'Affiliation': '6MRC-ARUK Centre for Musculoskeletal Ageing Research, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Inga-Lill', 'Initials': 'IL', 'LastName': 'Mårtensson', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Mannerkorpi', 'Affiliation': '2University of Gothenburg Centre for Person-Centred Care, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Gjertsson', 'Affiliation': '1Department of Rheumatology and Inflammation research, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 480, 405 30 Göteborg, Sweden.'}]",Immunity & ageing : I & A,['10.1186/s12979-020-00184-y']
2973,32467735,The effectiveness of cognitive- behavioral therapy on quality of life in women with hypothyroidism in the reproductive age: a randomized controlled trial.,"Background
Worldwide, hypothyroidism affects 3.7% of the population, and is associated with impaired quality of life. This study aimed to evaluate the effect of cognitive- behavioral therapy (CBT) on the quality of life in women with hypothyroidism.
Methods
96 women with hypothyroidism randomly allocated into two groups: CBT group ( n = 48) and control group (n = 48). Women in the CBT group were classified into four sub-groups of 12, and each sub-group received eight sessions of counseling (each session lasting 90 min). We collected data using a demographic questionnaire and the 36-Item Short Form Health Survey (SF 36) for measuring the quality of life. We used the independent t-test, chi-square test and ANCOVA to analyze the data.
Results
Five women from each group withdrew from the study, leaving 43 women in each group. The scores on physical functioning, physical health problems, social functioning and pain improved in the CBT group after the intervention, but the differences between the two groups were not significant. The scores on emotional health, emotional health problems, energy and emotions, and general health were significantly better in the CBT group than those in the control group ( p < 0.05).
Conclusion
Counseling using CBT can improve some aspects of quality of life, including emotional health, emotional health problems, energy and general health in patients with hypothyroidism.
Trial registration number
Iranian Registry for Clinical Trials: 20190323043101 N1. https://www.irct.ir/.",2020,"The scores on physical functioning, physical health problems, social functioning and pain improved in the CBT group after the intervention, but the differences between the two groups were not significant.","['patients with hypothyroidism', '96 women with hypothyroidism', 'women with hypothyroidism', 'women with hypothyroidism in the reproductive age', 'Five women from each group withdrew from the study, leaving 43 women in each group']","['CBT', 'cognitive- behavioral therapy (CBT', 'cognitive- behavioral therapy']","['quality of life', 'physical functioning, physical health problems, social functioning and pain', 'quality of life, including emotional health, emotional health problems, energy and general health', 'emotional health, emotional health problems, energy and emotions, and general health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446390', 'cui_str': 'Physical health problems'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",96.0,0.0749025,"The scores on physical functioning, physical health problems, social functioning and pain improved in the CBT group after the intervention, but the differences between the two groups were not significant.","[{'ForeName': 'Sohaila', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': '1MS. c Candidate in Midwifery Department, Reproductive Health Promotion Research Centre, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Abedi', 'Affiliation': '2PhD in Community Nutrition, Associate Professor in Midwifery Department, Menopause Andropause Research Centre, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Maraghi', 'Affiliation': '3PhD of Biostatistics, Assistant Professor, Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Hamid', 'Affiliation': '4Associate Professor of Clinical Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran.'}, {'ForeName': 'Homaira', 'Initials': 'H', 'LastName': 'Rashidi', 'Affiliation': '5Associate Professor in Endocrinology Department, Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Thyroid research,['10.1186/s13044-020-00080-z']
2974,32467763,The effects of hypoxia on muscle deoxygenation and recruitment in the flexor digitorum superficialis during submaximal intermittent handgrip exercise.,"Background
Decreased oxygenation of muscle may be accentuated during exercise at high altitude. Monitoring the oxygen saturation of muscle (SmO 2 ) during hand grip exercise using near infrared spectroscopy during acute exposure to hypoxia could provide a model for a test of muscle performance without the competing cardiovascular stresses that occur during a cycle ergometer or treadmill test. The purpose of this study was to examine and compare acute exposure to normobaric hypoxia versus normoxia on deoxygenation and recruitment of the flexor digitorum superficialis (FDS) during submaximal intermittent handgrip exercise (HGE) in healthy adults.
Methods
Twenty subjects (11 M/9 F) performed HGE at 50% of maximum voluntary contraction, with a duty cycle of 2 s:1 s until task failure on two occasions one week apart, randomly assigned to normobaric hypoxia (FiO 2 = 12%) or normoxia (FiO 2 = 21%). Near-infrared spectroscopy monitored SmO 2 , oxygenated (O 2 Hb), deoxygenated (HHb), and total hemoglobin (tHb) over the FDS. Surface electromyography derived root mean square and mean power frequency of the FDS.
Results
Hypoxic compared to normoxic HGE induced a lower FDS SmO 2 (63.8 ± 2.2 vs. 69.0 ± 1.5, p = 0.001) and both protocols decreased FDS SmO 2 from baseline to task failure. FDS mean power frequency was lower during hypoxic compared to normoxic HGE (64.0 ± 1.4 vs. 68.2 ± 2.0 Hz, p = 0.04) and both decreased mean power frequency from the first contractions to task failure ( p = 0.000). Under both hypoxia and normoxia, HHb, tHb and root mean square increased from baseline to task failure whereas O 2 Hb decreased and then increased during HGE. Arterial oxygen saturation via pulse oximetry (SpO 2 ) was lower during hypoxia compared to normoxia conditions ( p = 0.000) and heart rate and diastolic blood pressure only demonstrated small increases. Task durations and the tension-time index of HGE did not differ between normoxic and hypoxic trials.
Conclusion
Hypoxic compared to normoxic HGE decreased SmO 2 and induced lower mean power frequency in the FDS, during repetitive hand grip exercise however did not result in differences in task durations or tension-time indices. The fiber type composition of FDS, and high duty cycle and intensity may have contributed greater dependence on anaerobiosis.",2020,"FDS mean power frequency was lower during hypoxic compared to normoxic HGE (64.0 ± 1.4 vs. 68.2 ± 2.0 Hz, ",['healthy adults'],"['submaximal intermittent handgrip exercise (HGE', 'hand grip exercise', 'normoxic HGE', 'normobaric hypoxia versus normoxia', 'hypoxia']","['FDS mean power frequency', 'oxygenated (O 2 Hb), deoxygenated (HHb), and total hemoglobin (tHb', 'hypoxia and normoxia, HHb, tHb and root mean square', 'task durations or tension-time indices', 'heart rate and diastolic blood pressure', 'Arterial oxygen saturation via pulse oximetry (SpO 2 ', 'Task durations and the tension-time index of HGE']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0224258', 'cui_str': 'Structure of flexor digitorum superficialis muscle of hand'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0057437', 'cui_str': 'Deoxyhemoglobin'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.051533,"FDS mean power frequency was lower during hypoxic compared to normoxic HGE (64.0 ± 1.4 vs. 68.2 ± 2.0 Hz, ","[{'ForeName': 'Hayley J', 'Initials': 'HJ', 'LastName': 'Nell', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Castelli', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Bertani', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Aaron A', 'Initials': 'AA', 'LastName': 'Jipson', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Sean F', 'Initials': 'SF', 'LastName': 'Meagher', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Luana T', 'Initials': 'LT', 'LastName': 'Melo', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Zabjek', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}, {'ForeName': 'W Darlene', 'Initials': 'WD', 'LastName': 'Reid', 'Affiliation': '1Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON M5G 1V7 Canada.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00163-2']
2975,32467770,Auditory rhythmical cueing to improve gait and physical activity in community-dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial.,"Background
Mobility problems are present in 70-80% of stroke survivors and can result in impaired gait and reduced physical activity limiting independent living. Auditory rhythmic cueing (ARC) has been used to provide auditory feedback and shows promise in improving a variety of walking parameters following stroke. The aim of this pilot study is to assess the feasibility of conducting a multi-centre, observer blind, randomised controlled trial of auditory rhythmical cueing (ARC) intervention in home and community settings in North East England.
Methods
This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England. Participants will be within 24 months of stroke onset causing new problems with mobility. Each participant will be randomised to the study intervention or control group. Intervention treatment participants will undertake 18 auditory rhythmical cueing (ARC) treatment sessions over 6 weeks (3 × 30 min per week, 6 supervised (physiotherapist/research associate)/12 self-managed) in a home/community setting. A metronome will be used to provide ARC during a series of balance and gait exercises, which will be gradually progressed. The control treatment participants will undertake the same duration balance and gait exercise training programme as the intervention group but without the ARC. Feasibility will be determined in terms of recruitment, retention, adverse events, adherence, collection of descriptive clinical and accelerometer motor performance data at baseline, 6 weeks and 10 weeks and description of participant, provider and clinical therapists' experiences. As well as using questionnaires to collate participant views, qualitative interviews will be undertaken to further understand how the intervention is delivered in practice in a community setting and to identify aspects perceived important by participants.
Discussion
The ACTIVATE study will address an important gap in the evidence base by reporting whether it is feasible to deliver auditory rhythmical cueing in the home and community to improve gait and balance parameters following stroke. The feasibility of the study protocol will be established and results will inform the design of a future multi-centre randomised controlled trial.
Trial registration
Trial register: ISRCTN, Trial identifier: ISRCTN10874601: Date of registration: 12/03/2018.",2020,This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England.,"['community-dwelling stroke survivors (ACTIVATE', 'home and community settings in North East England', '60 participants over 15\u2009months from community stroke services in the North East of England']","['Auditory rhythmic cueing (ARC', '18 auditory rhythmical cueing (ARC) treatment sessions', 'auditory rhythmical cueing (ARC) intervention', 'gait exercise training programme', 'Auditory rhythmical cueing']",['gait and physical activity'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0587667', 'cui_str': 'Stroke service'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.158237,This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England.,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCue', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Del Din', 'Affiliation': '2Institute of Neuroscience Henry Wellcome Building, The Medical School, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hunter', 'Affiliation': '2Institute of Neuroscience Henry Wellcome Building, The Medical School, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lord', 'Affiliation': '5Auckland University of Technology, 55 Wellesley St E, Auckland, 1010 New Zealand.'}, {'ForeName': 'Christopher I M', 'Initials': 'CIM', 'LastName': 'Price', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rodgers', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': '2Institute of Neuroscience Henry Wellcome Building, The Medical School, Framlington Place, Newcastle University, Newcastle upon Tyne, NE2 4HH UK.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Moore', 'Affiliation': '1Stroke Research Group, Institute of Neuroscience Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00605-1']
2976,32468741,Pharmacokinetics and Safety of Two Voriconazole Formulations After Intravenous Infusion in Healthy Korean Volunteers.,"BACKGROUND
Voriconazole, a triazole antifungal agent exhibits broad-spectrum antifungal activity. It is used to treat severe, invasive fungal infections, including invasive aspergillosis and candidemia. The aim of this study was to assess the pharmacokinetic equivalence of a test formulation (Vorico® Injection) and reference formulation (Vfend® IV) of voriconazole.
MATERIALS AND METHODS
This was a randomized, open-label, single-dose, three-group, two-treatment, two-sequence, two-period, crossover phase I trial with 7-day washout periods (ClinicalTrials.gov identifier NCT02631954). Twenty-four healthy Korean male subjects were recruited. In each group, eight subjects were randomized in a 1:1 manner to receive a single dose of 200 mg test or reference formulation intravenously over 1.5 h. Blood samples were collected over 24 h post-dose, and plasma drug concentrations were determined by liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were determined using a non-compartmental analysis, and safety was evaluated.
RESULTS
Twenty-three subjects completed the study. The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570 (0.8178 - 1.1199) for the maximum plasma concentration (C max ) and 1.0720 (1.0262 - 1.1198) for the area under the concentration-time curve from dosing to the last quantifiable concentration (AUC last ). The mean plasma concentration-time profiles, pharmacokinetic parameters, and safety were comparable between the two formulations.
CONCLUSION
Equivalent pharmacokinetic characteristics that satisfied the criteria of bioequivalence and similar safety profiles were observed for both test and reference formulations of voriconazole.",2020,The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570,"['Twenty-three subjects completed the study', 'Twenty-four healthy Korean male subjects were recruited', 'Healthy Korean Volunteers']","['Two Voriconazole Formulations', 'test formulation (Vorico® Injection) and reference formulation (Vfend® IV) of voriconazole']","['geometric mean ratio', 'maximum plasma concentration (C max ', 'mean plasma concentration-time profiles, pharmacokinetic parameters, and safety', 'pharmacokinetic equivalence']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1136812', 'cui_str': 'Vfend'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",8.0,0.088423,The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570,"[{'ForeName': 'Sang Heon', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea. shcho123@inha.ac.kr.'}, {'ForeName': 'Cheol Woo', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}, {'ForeName': 'Moon Suk', 'Initials': 'MS', 'LastName': 'Nam', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}]",Infection & chemotherapy,[]
2977,32469373,A Randomized Controlled Trial of Power Posing on Timed Up and Go Test.,"BACKGROUND
Integrating psychological principles into physical therapy treatment may enhance patient outcomes. One intervention strategy from psychological perspectives that could be integrated in physical therapy practice is power posing. There is a lack of research on the effects of power posing on functional outcomes commonly used in physical therapy.
OBJECTIVE
To determine the effects of power posing on the timed up and go test score.
DESIGN
Randomized controlled trial.
METHODS
Subjects in the experimental group were instructed to stand with hands on their hips, elbows pointing out and feet approximately 1 foot apart for 20 s. Subjects in the control group were instructed to stand with hands and arms wrapping around the torso and feet together for 20 s. Timed up and go test was administered using an OmniVR Virtual Rehabilitation System before and after the postural intervention.
RESULTS
The timed up and go test score changed by -0.17 s (SD 0.65) and -0.20 s (SD 0.43) for the experimental and control groups, respectively (p=0.87).
CONCLUSIONS
The timed up and go test scores for both experimental and control groups improved slightly. However, the results did not show significant effects of power posing in the timed up and go test scores.",2020,"The timed up and go test score changed by -0.17 s (SD 0.65) and -0.20 s (SD 0.43) for the experimental and control groups, respectively (p=0.87).
","['Subjects in the experimental group were instructed to stand with hands on their hips, elbows pointing out and feet approximately 1 foot apart for 20 s. Subjects in the']",['control group were instructed to stand with hands and arms wrapping around the torso and feet together for 20 s'],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]",[],20.0,0.026404,"The timed up and go test score changed by -0.17 s (SD 0.65) and -0.20 s (SD 0.43) for the experimental and control groups, respectively (p=0.87).
","[{'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Ge', 'Affiliation': 'Dep. of Physical Therapy, Youngstown State University, One University Plaza, Youngstown, OH 44555, USA. Tel 330-941-2702, fax 330-941-1898. wge@ysu.edu.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Schaefer', 'Affiliation': ''}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Basile', 'Affiliation': ''}]",Journal of allied health,[]
2978,32469375,Mind Mapping to Enhance Critical Thinking Skills in Physician Assistant Education: A Randomized Controlled Study.,"Physician assistant (PA) students need to assimilate and integrate voluminous information quickly and effectively to promote critical thinking skills required to deliver competent care. Mind mapping (MM) is an innovative strategy used to facilitate students' recognition and recall of essential information and to ensure depth in their understanding via making connections between pieces of information. The establishment of relationships between concepts expressed in mind maps enhances critical thinking skills. The purpose of this study was to determine the overall critical thinking skills of PA students using MM as a learning strategy and to determine if there was a significant difference in critical thinking skills between students who used MM versus standard note-taking in their learning environment. In this randomized control study, a convenience sample of 74 PA students was assigned to a standard note-taking group (SNTG) or mind-mapping group (MMG). After completing the Health Science Reasoning Test (pre-HSRT), MMG members were instructed on how to construct mind maps and then asked to create weekly mind maps for 9 weeks, while the SNTG followed their method of study without mind maps for 9 weeks. Differences in the mean pre- and post-overall HSRT scores between groups and within groups were analyzed using independent and dependent t-tests, respectively. There was no significant difference between pre- and post-overall critical thinking scores as measured by HSRT after 9 weeks of intervention in both groups. However, there was a significant difference in the mean overall post-HSRT scores between groups (p=0.026). Hence, mind mapping is a viable active learning strategy to promote critical thinking in PA students.",2020,There was no significant difference between pre- and post-overall critical thinking scores as measured by HSRT after 9 weeks of intervention in both groups.,"['Physician Assistant Education', 'students who used MM versus standard note-taking in their learning environment', 'convenience sample of 74 PA students']","['standard note-taking group (SNTG) or mind-mapping group (MMG', 'Mind mapping (MM']","['pre- and post-overall critical thinking scores', 'mean overall post-HSRT scores', 'mean pre- and post-overall HSRT scores', 'critical thinking skills', 'overall critical thinking skills']","[{'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",74.0,0.0511298,There was no significant difference between pre- and post-overall critical thinking scores as measured by HSRT after 9 weeks of intervention in both groups.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Israel', 'Affiliation': 'School of Graduate Studies, Rutgers, Biomedical Sciences, 675 Hoes Lane, Research Tower Rm 102, Piscataway, NJ 08854, USA. Tel 732-407-5724. israelcyn@gmail.com.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Pinto Zipp', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': ""D'Abundo"", 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Deluca', 'Affiliation': ''}]",Journal of allied health,[]
2979,32445902,"The impact of height-adjustable desks and classroom prompts on classroom sitting time, social, and motivational factors among adolescents.","PURPOSE
This quasi-experimental study examined the impact of height-adjustable desks in combination with prompts to break up prolonged sitting time during class time and identified social and motivational factors associated with breaking up sitting time among adolescents. Teachers' perceptions of strategies were also examined.
METHODS
Over 17 weeks, 1 classroom in a government secondary school in Melbourne, Australia, was equipped with 27 height-adjustable desks and prompts (posters and desk stickers) to break up classroom sitting time. Teachers received professional development in the use of the desks and prompts. One group of adolescents (n = 55) had 2-5 lessons/week using the height-adjustable desks in an intervention classroom, and a comparison group matched by year level and subject (n = 50) was taught in traditional ""seated"" classrooms. Adolescents wore an activPAL monitor at baseline (T0), 4 weeks (T1), and 17 weeks (T2) and completed a survey at T0 and T2. Six teachers participated in interviews at T2. Effect sizes were calculated (d).
RESULTS
Linear mixed models found that, compared to the traditional ""seated"" classrooms, the adolescents in the intervention classroom had significantly lower sitting time (T1: -9.7 min/lesson, d = -0.96; T2: -6.7 min/lesson, d = -0.70) and time spent in sitting bouts >15 min (T2: -11 min/lesson, d = -0.62) and had significantly higher standing time (T1: 7.3 min/lesson, d = 0.84; T2: 5.8 min/lesson, d = 0.91), number of breaks from sitting (T1: 1.3 breaks/lesson, d = 0.49; T2: 1.8 breaks/lesson, d = 0.67), and stepping time (T1: 2.5 min/lesson, d = 0.66). Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50).
CONCLUSION
This intervention shows promise for targeting sitting behaviors in the classroom and indicates that incorporating social and motivational strategies may further enhance outcomes.",2020,"Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50).
","['Six teachers participated in interviews at T2', 'adolescents']",[],"['standing time', 'habit strength', 'self-efficacy for breaking up sitting time', 'sitting time', 'classroom sitting time, social, and motivational factors', 'stepping time', 'time spent in sitting bouts >15 min', 'number of breaks from sitting']","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0445131', 'cui_str': 'Number of breaks'}]",6.0,0.0132516,"Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50).
","[{'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Sudholz', 'Affiliation': 'Pomegranate Community Mental Health, St John of God Social Outreach, Ballarat, VIC 3350, Australia.'}, {'ForeName': 'Ana María Contardo', 'Initials': 'AMC', 'LastName': 'Ayala', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia. Electronic address: a.contardoayala@deakin.edu.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Timperio', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia; Physical Activity Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia; Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Conroy', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA 16802, USA; Department of Preventive Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Abbott', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Holland', 'Affiliation': 'The Australian Council for Health and Physical Education and Recreation, Abbotsford, VIC 3067, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Arundell', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.05.002']
2980,32445969,How do oncoming traffic and cyclist lane position influence cyclist overtaking by drivers?,"Overtaking cyclists is challenging for drivers because it requires a well-timed, safe interaction between the driver, the cyclist, and the oncoming traffic. Previous research has investigated this manoeuvre in different experimental environments, including naturalistic driving, naturalistic cycling, and simulator studies. These studies highlight the significance of oncoming traffic-but did not extensively examine the influence of the cyclist's position within the lane. In this study, we performed a test-track experiment to investigate how oncoming traffic and position of the cyclist within the lane influence overtaking. Participants overtook a robot cyclist, which was controlled to ride in two different lateral positions within the lane. At the same time, an oncoming robot vehicle was controlled to meet the participant's vehicle with either 6 or 9 s time-to-collision. The order of scenarios was randomised over participants. We analysed safety metrics for the four different overtaking phases, reflecting drivers' safety margins to rear-end, head-on, and side-swipe collisions, in order to investigate the two binary factors: 1) time gap between ego vehicle and oncoming vehicle, and 2) cyclist lateral position. Finally, the effects of these two factors on the safety metrics and the overtaking strategy (either flying or accelerative depending on whether the overtaking happened before or after the oncoming vehicle had passed) were analysed. The results showed that, both when the cyclist rode closer to the centre of the lane and when the time gap to the oncoming vehicle was shorter, safety margins for all potential collisions decreased. Under these conditions, drivers-particularly female drivers-preferred accelerative over flying manoeuvres. Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.",2020,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,[],[],[],[],[],[],,0.0264438,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rasch', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: alexander.rasch@chalmers.se.'}, {'ForeName': 'Christian-Nils', 'Initials': 'CN', 'LastName': 'Boda', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: christian-nils.boda@chalmers.se.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Thalya', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden; Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: prateek.thalya@veoneer.com.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Aderum', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: tobias.aderum@veoneer.com.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Knauss', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: alessia.knauss@veoneer.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Dozza', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: marco.dozza@chalmers.se.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105569']
2981,32446298,Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trial.,"BACKGROUND
Treatment with beta-blockers is currently recommended after myocardial infarction (MI). The evidence relies on trials conducted decades ago before implementation of revascularization and contemporary medical therapy or in trials enrolling patients with heart failure or reduced left ventricular ejection fraction (LVEF ≤ 40%). Accordingly, the impact of beta-blockers on mortality and morbidity following acute MI in patients without reduced LVEF or heart failure is unclear.
METHODS/DESIGN
The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure. We will randomize 3570 patients will be randomized within 14 days of index MI to beta-blocker or control for a minimum of 2 years. The primary endpoint is a composite of all-cause mortality, recurrent MI, acute decompensated heart failure, unstable angina pectoris, or stroke. The primary composite endpoint will be assessed through locally reported and adjudicated endpoints supplemented by linkage to the Danish national registers. A number of secondary endpoints will be investigated including patient reported outcomes and cardiovascular mortality. Data from similar ongoing trials in Norway and Sweden will be pooled to perform an individual patient data meta-analysis.
DISCUSSION
DANBLOCK is a randomized clinical trial investigating the effect of long-term beta-blocker therapy after myocardial infarction in patients without heart failure and reduced LVEF. Results from the trial will add important scientific evidence to inform future clinical guidelines.
TRIAL REGISTRATION
Clinicaltrials.gov, NCT03778554. Registered on 19 December 2018. European Clinical Trials Database, 2018-002699-42, registered on 28 September 2018.",2020,"The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure.","['patients without reduced LVEF or heart failure', '3570 patients', 'post-MI patients in the absence of reduced LVEF or heart failure', 'trials enrolling patients with heart failure or reduced left ventricular ejection fraction (LVEF ≤\u200940', 'after myocardial infarction without reduced ejection fraction', '2018-002699-42, registered on 28 September 2018', 'patients without heart failure and reduced LVEF']","['beta-blocker treatment', 'beta-blocker', 'beta-blockers', 'long-term beta-blocker therapy']","['cardiovascular mortality', 'mortality and morbidity', 'composite of all-cause mortality, recurrent MI, acute decompensated heart failure, unstable angina pectoris, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",3570.0,0.267334,"The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure.","[{'ForeName': 'Anna Meta Dyrvig', 'Initials': 'AMD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark. anna.meta.dyrvig.kristensen.02@regionh.dk.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bovin', 'Affiliation': 'Department of Cardiology, Sygehus Lillebælt, Vejle, Denmark.'}, {'ForeName': 'Ann Dorthe', 'Initials': 'AD', 'LastName': 'Zwisler', 'Affiliation': 'Danish Centre for Rehabilitation and Palliative Care, Odense University Hospital and University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cerquira', 'Affiliation': 'The Regional Clinical Quality Development Program, Aarhus, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Karsten Tange', 'Initials': 'KT', 'LastName': 'Veien', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Kristian Korsgaard', 'Initials': 'KK', 'LastName': 'Thomsen', 'Affiliation': 'Department of Cardiology, Sydvestjysk Sygehus, Esbjerg, Denmark.'}, {'ForeName': 'Michael Hecht', 'Initials': 'MH', 'LastName': 'Olsen', 'Affiliation': 'Department of Internal Medicine, Holbæk Hospital, Holbæk, Denmark.'}, {'ForeName': 'Mogens Lytken', 'Initials': 'ML', 'LastName': 'Larsen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Olav Wendelboe', 'Initials': 'OW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Cardiology, Frederiksberg Heart Clinic, Copenhagen, Denmark.'}, {'ForeName': 'Sussie', 'Initials': 'S', 'LastName': 'Foghmar', 'Affiliation': 'Department of Cardiology, Hvidovre-Amager Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Svend Eggert', 'Initials': 'SE', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sehested', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jernberg', 'Affiliation': 'Department of Clinical Sciences, Division of Cardiology, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Atar', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibanez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC) & IIS- Fundación Jiménez Díaz & CIBERCV, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prescott', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-4214-6']
2982,32446304,Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial.,"BACKGROUND
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a complex endoscopic procedure that requires moderate to deep sedation. Propofol is the sedative agent of choice for sedation in ERCP due to its fast distribution and fast elimination time without a cumulative effect after infusion, resulting in shorter recovery time. Benzydamine hydrochloride is a topical non-steroidal anti-inflammatory drug that has analgesic, local anesthetic, and anti-inflammatory effects that have been known to be effective in reducing postoperative sore throat. Combination of propofol and topical analgesic may provide adequate sedation and reduce propofol consumption. This study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the ERCP procedure.
METHODS
This study was a single-blind randomized controlled trial for patients undergoing ERCP procedures at Cipto Mangunkusumo Hospital from August to September 2018. A total of 72 subjects were recruited consecutively and randomly assigned into two groups. The first group received 15 mL of 0.15% benzydamine hydrochloride mouthwash prior to the procedure, whereas the second group received 15 mL of water mouthwash. Additional propofol was administered when patient moved or Ramsay Sedation Scale rose above 4. Cumulative propofol consumption per kg body weight per minute and incidence of postoperative sore throat were recorded in each group. Incidence of desaturation, postoperative nausea vomitting, and dysphagia were also recorded. Data analysis was performed with Statistical Package for the Social Sciences.
RESULTS
Cumulative propofol consumption per minute per kg body weight in the benzydamine hydrochloride group was 152.7 (91.9-238.8) mcg/kg/minute, while in the control group was 200.05 (114.4-380.2) mcg/kg/ minute (p = < 0.001). The incidence of sore throat on the 0th, 2nd, and 4th hour for the benzydamine hydrochloride group was 11.4, 11.4, and 5.7%, while in the control group was 50, 52.8, and 36.1% (p = < 0.001, < 0.001, 0.003). Desaturation was found in control group whereas none in benzydamine hydrochloride group. Complaints of nausea and vomiting were comparable in both groups.
CONCLUSION
Benzydamine hydrochloride gargling was effective in reducing cumulative propofol consumption in the ERCP procedure.
TRIAL REGISTRATION
Study was registered retrospectively in ClinicalTrials.gov with NCT04167592 on November 8th 2019.",2020,"Complaints of nausea and vomiting were comparable in both groups.
","['endoscopic retrograde cholangiopancreatography procedure', 'A total of 72 subjects', 'patients undergoing ERCP procedures at Cipto Mangunkusumo Hospital from August to September 2018']","['Benzydamine hydrochloride', '15\u2009mL of 0.15% benzydamine hydrochloride', 'propofol', 'propofol and topical analgesic', 'Endoscopic Retrograde Cholangiopancreatography (ERCP', 'benzydamine hydrochloride', 'Propofol', '15\u2009mL of water mouthwash', 'benzydamine hydrochloride gargle']","['Incidence of desaturation, postoperative nausea vomitting, and dysphagia', 'Cumulative propofol consumption per minute per kg body weight', 'cumulative propofol consumption', 'Desaturation', 'Complaints of nausea and vomiting', 'Cumulative propofol consumption per kg body weight per minute and incidence of postoperative sore throat', 'propofol consumption', 'incidence of sore throat']","[{'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0282070', 'cui_str': 'Benzydamine hydrochloride'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}]",72.0,0.100761,"Complaints of nausea and vomiting were comparable in both groups.
","[{'ForeName': 'Adhrie', 'Initials': 'A', 'LastName': 'Sugiarto', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia. adhrie@gmail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kapuangan', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia.'}, {'ForeName': 'Aida Rosita', 'Initials': 'AR', 'LastName': 'Tantri', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chrisnata', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia.'}]",BMC anesthesiology,['10.1186/s12871-020-00996-x']
2983,32446306,Fenofibrate decreased microalbuminuria in the type 2 diabetes patients with hypertriglyceridemia.,"BACKGROUND
This study was to research the efficacy of fenofibrate in the treatment of microalbuminuria in the patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia.
METHODS
Type 2 diabetic patients (56) with microalbuminuria and hypertriglyceridemia aged 30 to 75 were randomly divided into the fenofibrate treatment group(n = 28) and the control group (n = 28) for 180 days. Urinary microalbumin /creatinine ratio (UACR) and other metabolic parameters were compared at baseline, during treatment and after treatment.
RESULTS
After 180 days, the reduction of level of fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c) between two groups showed no difference. In the treatment group, uric acid (UA) (296.42 ± 56.41 vs 372.46 ± 72.78), triglyceride (TG) [1.51(1.17, 2.06) vs 3.04(2.21, 3.29)], and UACR [36.45 (15.78,102.41) vs 129.00 (53.00, 226.25)] were significantly decreased compared with the baseline. The high-density lipoprotein cholesterol (HDL-C) levels were significantly increased (1.22 ± 0.26 vs 1.09 ± 0.24) compared with the baseline. The decrease in UACR [- 44.05(- 179.47, - 12.16) vs - 8.15(- 59.69, 41.94)]in treatment group was significantly higher compared with the control group. The decrease in UACR was positively associated with the decreases in TG (r = 0.447, P = 0.042) and UA (r = 0.478, P = 0.024) after fenofibrate treatment.
CONCLUSION
In the patients with hypertriglyceridemia and type 2 diabetes mellitus, fenofibrate can improve microalbuminuria and do not increase the deterioration of glomerular filtration rate.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02314533, 2014.12.9.",2020,The high-density lipoprotein cholesterol (HDL-C) levels were significantly increased (1.22 ± 0.26 vs 1.09 ± 0.24) compared with the baseline.,"['Type 2 diabetic patients (56) with microalbuminuria and hypertriglyceridemia aged 30 to 75', 'patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia', 'patients with hypertriglyceridemia and type 2 diabetes mellitus', 'type 2 diabetes patients with hypertriglyceridemia']","['Fenofibrate', 'fenofibrate', 'fenofibrate treatment group(n\u2009=\u200928) and the control group']","['uric acid (UA', 'microalbuminuria', 'UACR', 'triglyceride (TG', 'deterioration of glomerular filtration rate', 'TG', 'reduction of level of fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c', 'high-density lipoprotein cholesterol (HDL-C) levels', 'Urinary microalbumin /creatinine ratio (UACR) and other metabolic parameters']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.031251,The high-density lipoprotein cholesterol (HDL-C) levels were significantly increased (1.22 ± 0.26 vs 1.09 ± 0.24) compared with the baseline.,"[{'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Beijing Chao-Yang Hospital, Capital Medical University, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, P. R. China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Beijing Chao-Yang Hospital, Capital Medical University, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, P. R. China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Beijing Chao-Yang Hospital, Capital Medical University, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, P. R. China. drwg6688@126.com.'}]",Lipids in health and disease,['10.1186/s12944-020-01254-2']
2984,32448136,Application of CareDose 4D combined with Karl 3D technology in the low dose computed tomography for the follow-up of COVID-19.,"BACKGROUND
Coronavirus disease 2019 (COVID-19) is a highly infectious disease caused by the new coronavirus. Previous studies have shown that the chest CT examination plays an important role in the diagnosis and monitoring of COVID-19. However, some patients with COVID-19 had low white blood cell counts and reduced lymphocyte ratios. Multiple CT examinations may cause radiation damages as well as increase the apoptosis of peripheral blood lymphocytes. A new low-dose CT method should be developed because the regular CT may aggravate the disease.
METHOD
Sixty cases were randomly divided into the study group (n = 30) and control group (n = 30). The lung window was reconstructed by Karl 3D iterative technique in the study group. The image quality was subjectively evaluated by two senior chest group diagnostic physicians using a 5-point double-blind method. The value of CT measurement and its standard deviation (SD) was used as an objective evaluation criteria. The volume of CT dose index (CTDI vol ), dose length product (DLP) and effective dose (ED) from the two groups were compared and analyzed statistically.
RESULT
There was no significant difference in the occurrence rates of ground glass opacities, consolidation, crazy-paving pattern, fiber cable shadow and axial interstitial thickening between the study group and control group (p > 0.05). In addition, no significant difference was found for the subjective score of overall image quality and image noise level (SD) between the two groups (p > 0.05). However, significant differences was found in CTDI vol , DLP, and ED between the study group and the control group (p < 0.05). The effective dose of the study group was reduced by 76% compared to the control group.
CONCLUSION
CareDose 4D low-dose scanning combined with Karl 3D iterative reconstruction technology can not only greatly reduce the radiation dose, but also provide images that meet the diagnostic criteria of COVID-19, which can be used as a routine method for the follow-up of COVID-19 patients.",2020,"There was no significant difference in the occurrence rates of ground glass opacities, consolidation, crazy-paving pattern, fiber cable shadow and axial interstitial thickening between the study group and control group (p > 0.05).",['Sixty cases'],['CareDose 4D combined with Karl 3D technology'],"['CTDI vol , DLP, and ED', 'subjective score of overall image quality and image noise level (SD', 'value of CT measurement and its standard deviation (SD', 'low white blood cell counts and reduced lymphocyte ratios', 'apoptosis of peripheral blood lymphocytes', 'occurrence rates of ground glass opacities, consolidation, crazy-paving pattern, fiber cable shadow and axial interstitial thickening', 'image quality', 'volume of CT dose index (CTDI vol ), dose length product (DLP) and effective dose (ED']","[{'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0085195', 'cui_str': 'Shadowing (Histology)'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.0175715,"There was no significant difference in the occurrence rates of ground glass opacities, consolidation, crazy-paving pattern, fiber cable shadow and axial interstitial thickening between the study group and control group (p > 0.05).","[{'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Xiaolu', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Fangxing', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Biochemistry and Molecular Biology, China Medical University, Shenyang, 110122, China.'}, {'ForeName': 'Guangzuo', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': 'Institute of Translational Medicine, China Medical University, Shenyang, 110122, China. gzluo@cmu.edu.cn.'}, {'ForeName': 'Xunhua', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, China Resources & WISCO General Hospital, Wuhan, 430080, China. xxhwh@163.com.'}]",BMC medical imaging,['10.1186/s12880-020-00456-5']
2985,32448335,Combined use of apatinib mesylate and vinorelbine versus vinorelbine alone in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial.,"BACKGROUND
The emergence of new molecular targeted drugs provides new prospects for the treatment of advanced breast cancer; the future therapeutic trend includes chemotherapy combined with molecular targeted therapy. Apatinib mesylate, a novel, small anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase. Apatinib mesylate also blocks the signaling of vascular endothelial growth factor binding to its receptor, thereby strongly inhibiting tumor angiogenesis and exerting an anti-tumor effect. However, there have been no reports of a randomized controlled clinical trial of apatinib combined with vinorelbine for the treatment of triple-negative breast cancer (TNBC). We will compare the therapeutic effect of vinorelbine alone or in combination with apatinib mesylate, in patients with recurrent or metastatic TNBC in North China who have received at least two drug treatments, including anthracyclines and taxanes.
METHODS/ANALYSIS
This study is a triple-blind, randomized, placebo-controlled, parallel-group clinical trial. We plan to include 238 female patients with locally recurrent or metastatic TNBC, admitted to the Liaoning Cancer Hospital & Institute, Northeast China. All enrolled patients will be randomized to oral vinorelbine alone (40 mg, thrice a week (Mondays, Wednesdays, and Fridays) in each 3-week cycle), or in combination with oral apatinib mesylate (500 mg, once daily in each 3-week cycle). Radiographic assessment will be performed every 6 weeks for 36 weeks and every 9 weeks thereafter. The primary outcome is progression-free survival and secondary outcomes include overall survival, disease control rate, objective response rate, and incidence of adverse events at grades 3 and 4, as defined by the National Cancer Institute Common Toxicity Criteria Version 4.0. Outcome measures will be evaluated at baseline (< 2 weeks before starting treatment), every 6 weeks during treatment, and at 4 weeks and every 3 months after treatment discontinuation.
DISCUSSION
Based on the data from this trial, we hope to identify a treatment plan that is suitable for female patients with TNBC, who have been treated with anthracyclines and taxanes, in Northeast China.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03932526. Registered on 30 April 2019.",2020,"Apatinib mesylate, a novel, small anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase.","['238 female patients with locally recurrent or metastatic TNBC, admitted to the Liaoning Cancer Hospital & Institute, Northeast China', 'female patients with TNBC, who have been treated with anthracyclines and taxanes, in Northeast China', 'advanced breast cancer', 'recurrent or metastatic triple-negative breast cancer', 'patients with recurrent or metastatic TNBC in North China who have received at least two drug treatments, including anthracyclines and taxanes', 'triple-negative breast cancer (TNBC']","['vinorelbine', 'oral vinorelbine alone', 'vinorelbine alone', 'vinorelbine alone or in combination with apatinib mesylate', 'apatinib mesylate and vinorelbine', 'oral apatinib mesylate', 'placebo']","['progression-free survival', 'overall survival, disease control rate, objective response rate, and incidence of adverse events at grades 3 and 4, as defined by the National Cancer Institute Common Toxicity Criteria Version 4.0']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4547969', 'cui_str': 'apatinib mesylate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",238.0,0.175538,"Apatinib mesylate, a novel, small anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase.","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Junnan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110042, Liaoning Province, China. jianong@126.com.'}]",Trials,['10.1186/s13063-020-04342-x']
2986,32448358,A randomized controlled study of immediate versus delayed umbilical cord clamping in infants born by elective caesarean section.,"BACKGROUND
Delayed umbilical cord clamping is associated with greater haemoglobin concentration and iron storage between 3 and 6 months of life and with less need of blood transfusion and lower incidence of neonatal hypotension compared to early umbilical cord clamping.
METHODS
The aim was to test the hypothesis that delayed cord clamping is better than early cord clamping in term infants born by elective caesarean section. Group A was subjected to immediate cord clamping while in the Group B, the umbilical cord was clamped 1 min after birth. Primary aim was revealed the difference in pre-ductal saturation between two groups while secondary aim was investigating the difference in HR, Ht, bilirubin and glycaemia. Pre-ductal SpO 2 and HR were recorded at 5 and 10 min after birth, T was analysed 10 min after birth, glycaemia was revealed at 120 min while Ht and bilirubin were collected at 72 h.
RESULTS
132 newborns were enrolled in the study and allocated in ratio 1:1 to group A or B. Delayed cord clamping did not improve SpO 2, HR and T values compared to immediate cord clamping (p > 0,05). However, Group B showed greater haematocrit and bilirubin values at 72 h compared to Group A (56,71 ± 6663 vs 51,56 ± 6929; p < 0,05 and 8,54 ± 2,90 vs 7,06 ± 2,76; p < 0,05). Glycaemia value did not differ between two groups (p > 0,05).
CONCLUSIONS
Group B did not reveal any differences in SpO 2 , HR, T and glycaemia compared to Group A. Group B showed greater values of haematocrit and bilirubin but without need of phototherapy.
TRIAL REGISTRATION
Umbilical Cord Clamping: What Are the Benefits; NCT03878602. Registered 18 March 2019 retrospectively registered.",2020,"Glycaemia value did not differ between two groups (p > 0,05).
","['infants born by elective caesarean section', 'term infants born by elective caesarean section', '132 newborns']","['Umbilical Cord Clamping', 'immediate versus delayed umbilical cord clamping']","['HR, Ht, bilirubin and glycaemia', 'haematocrit and bilirubin values', 'SpO 2 , HR, T and glycaemia', 'haemoglobin concentration and iron storage', 'pre-ductal saturation', 'Glycaemia value', 'ductal SpO 2 and HR', 'haematocrit and bilirubin', 'neonatal hypotension']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1272667', 'cui_str': 'Born by elective cesarean section'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C0405737', 'cui_str': 'Umbilical cord clamping'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0455995', 'cui_str': 'Neonatal hypotension'}]",132.0,0.146248,"Glycaemia value did not differ between two groups (p > 0,05).
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Bernardo', 'Affiliation': 'Division of Pediatrics Neonatology and NICU, Ospedale Buon Consiglio Fatebenefratelli, Via Manzoni 220, 80123, Naples, Italy. pinodebtin@gmail.com.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Giordano', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'De Santis', 'Affiliation': 'School of specialization in Pediatrics, Catholic University of the Sacred Heart Faculty of Medicine and Surgery, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Castelli', 'Affiliation': 'School of specialization in Pediatrics, University of Pavia Faculty of Medicine and Surgery, Pavia, Italy.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Sordino', 'Affiliation': 'Department of Emergency-NICU, A.O.R.N. Santobono-Pausilipon, Naples, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Trevisanuto', 'Affiliation': ""Department of Woman's and Child's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Buonocore', 'Affiliation': 'Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.'}, {'ForeName': 'Serafina', 'Initials': 'S', 'LastName': 'Perrone', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}]",Italian journal of pediatrics,['10.1186/s13052-020-00835-2']
2987,32448392,Towards a fasting-mimicking diet for critically ill patients: the pilot randomized crossover ICU-FM-1 study.,"BACKGROUND
In two recent randomized controlled trials, withholding parenteral nutrition early in critical illness improved outcome as compared to early up-to-calculated-target nutrition, which may be explained by beneficial effects of fasting. Outside critical care, fasting-mimicking diets were found to maintain fasting-induced benefits while avoiding prolonged starvation. It is unclear whether critically ill patients can develop a fasting response after a short-term nutrient interruption. In this randomized crossover pilot study, we investigated whether 12-h nutrient interruption initiates a metabolic fasting response in prolonged critically ill patients. As a secondary objective, we studied the feasibility of monitoring autophagy in blood samples.
METHODS
In a single-center study in 70 prolonged critically ill patients, 12-h up-to-calculated-target feeding was alternated with 12-h fasting on day 8 ± 1 in ICU, in random order. Blood samples were obtained at the start of the study, at the crossover point, and at the end of the 24-h study period. Primary endpoints were a fasting-induced increase in serum bilirubin and decrease in insulin requirements to maintain normoglycemia. Secondary outcomes included serum insulin-like growth factor I (IGF-I), serum urea, plasma beta-hydroxybutyrate (BOH), and mRNA and protein markers of autophagy in whole blood and isolated white blood cells. To obtain a healthy reference, mRNA and protein markers of autophagy were assessed in whole blood and isolated white blood cells of 23 matched healthy subjects in fed and fasted conditions. Data were analyzed using repeated-measures ANOVA, Fisher's exact test, or Mann-Whitney U test, as appropriate.
RESULTS
A 12-h nutrient interruption significantly increased serum bilirubin and BOH and decreased insulin requirements and serum IGF-I (all p ≤ 0.001). Urea was not affected. BOH was already increased from 4 h fasting onwards. Autophagic markers in blood samples were largely unaffected by fasting in patients and healthy subjects.
CONCLUSIONS
A 12-h nutrient interruption initiated a metabolic fasting response in prolonged critically ill patients, which opens perspectives for the development of a fasting-mimicking diet. Blood samples may not be a good readout of autophagy at the tissue level.
TRIAL REGISTRATION
ISRCTN, ISRCTN98404761. Registered 3 May 2017.",2020,A 12-h nutrient interruption significantly increased serum bilirubin and BOH and decreased insulin requirements and serum IGF,"['patients and healthy subjects', 'critically ill patients', '23 matched healthy subjects in fed and fasted conditions', 'prolonged critically ill patients', '70 prolonged critically ill patients']",['12-h nutrient interruption'],"['metabolic fasting response', 'serum bilirubin and BOH and decreased insulin requirements and serum IGF', 'fasting-induced increase in serum bilirubin and decrease in insulin requirements to maintain normoglycemia', 'BOH', 'Urea', 'serum insulin-like growth factor I (IGF-I), serum urea, plasma beta-hydroxybutyrate (BOH), and mRNA and protein markers of autophagy in whole blood and isolated white blood cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0856666', 'cui_str': 'Serum urea'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",70.0,0.0616562,A 12-h nutrient interruption significantly increased serum bilirubin and BOH and decreased insulin requirements and serum IGF,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Van Dyck', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wilmer', 'Affiliation': 'Medical Intensive Care Unit, Department of Internal Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Schrijvers', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Derese', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Liese', 'Initials': 'L', 'LastName': 'Mebis', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Wouters', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gunst', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Michaël P', 'Initials': 'MP', 'LastName': 'Casaer', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium. michael.casaer@uzleuven.be.'}]","Critical care (London, England)",['10.1186/s13054-020-02987-3']
2988,32448401,"Comparison of the therapeutic effects of 15 mg and 30 mg initial dosage of prednisolone daily in patients with subacute thyroiditis: protocol for a multicenter, randomized, open, parallel control study.","BACKGROUND
Subacute thyroiditis (SAT) is the most common cause of thyroid pain. Several clinical guidelines recommend that patients who fail to respond to full doses of non-steroidal anti-inflammatory drugs (NSAIDs) should be treated instead with oral corticosteroid therapy. However, albeit strong recommendations, the treatment protocol is based on low-quality evidence and high-quality clinical trials are lacking with respect to the optimal initiation dosage and usage of corticosteroid. We aimed to evaluate whether 15 mg/day of prednisolone (PSL) as the initial dosage could provide non-inferiority effectiveness but with lower risk and more safety compared with 30 mg/day of PSL as the initial dosage.
METHODS/DESIGN
This is a multicenter, open-label, randomized, parallel trial that will be conducted at five academic hospitals in China. A total of 90 adult patients diagnosed with SAT who present moderate to severe pain or fail to respond to full doses of NSAIDs will be randomly assigned with a 1:1 ratio to the low initial PSL dosage group (15 mg daily) and standard initial PSL dosage group (30 mg daily). The primary endpoint is the time period (days) required for PSL treatment (including PSL treatment for recurrence).
DISCUSSION
Our randomized controlled trial will try to determine the optimal protocol in the treatment of SAT by providing high-quality evidence.
TRIALS REGISTRATION
Chinese Clinical Trial Register, ChiCTR1900023884. Registered on 15 June 2019.",2020,"The primary endpoint is the time period (days) required for PSL treatment (including PSL treatment for recurrence).
","['patients with subacute thyroiditis', 'patients who fail to respond to full doses of non-steroidal anti-inflammatory drugs (NSAIDs', 'five academic hospitals in China', '90 adult patients diagnosed with SAT who present moderate to severe pain or fail to respond to full doses of NSAIDs']","['prednisolone', 'prednisolone (PSL']",['time period (days) required for PSL treatment (including PSL treatment for recurrence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040149', 'cui_str': 'Subacute thyroiditis'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",90.0,0.143143,"The primary endpoint is the time period (days) required for PSL treatment (including PSL treatment for recurrence).
","[{'ForeName': 'Shaoyong', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Health Statistics, Shaanxi Key Laboratory of Free Radical Biology and Medicine and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Public Health, Air Force Medical University, Changle West Road No. 169, Xi'an, Shaanxi, 710032, China.""}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Department of Clinical Medicine, Medical College of Yan'an University, No. 38, Guanghua Road, Yan'an, 716000, China.""}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Jia', 'Affiliation': 'Department of Endocrinology, No.1 Hospital of Yulin, Yulin, 719000, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, 3201 Hospital of Xi'an Jiao tong University Health Science Center, 783 Tianhan Road, Hanzhong, Shaanxi, 723000, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Changle West Road No. 169, Xi'an, Shaanxi, 710032, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710032, China.""}, {'ForeName': 'Xiaorui', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': ""Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Changle West Road No. 169, Xi'an, Shaanxi, 710032, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Endocrinology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710032, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Endocrinology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710032, China.""}, {'ForeName': 'Wenlei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, Hubei, 441021, China.'}, {'ForeName': 'Ruikun', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, Hubei, 441021, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, Hubei, 441021, China. linggao048@sina.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': ""Department of Health Statistics, Shaanxi Key Laboratory of Free Radical Biology and Medicine and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Public Health, Air Force Medical University, Changle West Road No. 169, Xi'an, Shaanxi, 710032, China. shanglei@fmmu.edu.cn.""}]",Trials,['10.1186/s13063-020-04337-8']
2989,32448790,10-Valent pneumococcal non-typeable H. influenzae protein D conjugate vaccine (PHiD-CV10) versus 13-valent pneumococcal conjugate vaccine (PCV13) as a booster dose to broaden and strengthen protection from otitis media (PREVIX_BOOST) in Australian Aboriginal children: study protocol for a randomised controlled trial.,"INTRODUCTION
Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are major otitis media pathogens that densely co-colonise the nasopharynx and infect the middle ear of Australian Aboriginal infants from very early in life. Our co-primary hypotheses are that at 18 months of age infants receiving 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) compared with those receiving 13-valent pneumococcal conjugate vaccine (PCV13) as a booster at 12 months of age will have higher antibody levels to Haemophilus influenzae protein D and that infants receiving PCV13 will have higher antibody levels to PCV13-only serotypes 3, 6A and 19A.
METHODS AND ANALYSES
Our randomised controlled trial will enrol 270 Aboriginal children at 12 months of age to a booster dose of either PHiD-CV10 or PCV13. Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible. The co-primary assessor-blinded outcomes when the infants are 18 months of age are as follows: (a) IgG geometric mean concentration (GMC) and proportion with IgG ≥100 EU/mL for protein D, and (b) IgG GMC and the proportion with IgG ≥0.35 µg/mL for pneumococcal serotypes 3, 6A and 19A. Secondary immunogenicity comparisons of six primary and booster dose schedules of 10 shared serotypes at 18 months of age, nasopharyngeal carriage, all forms of otitis media, hearing loss and developmental milestones at 18, 24, 30 and 36 months of age will be reported.
ETHICS AND DISSEMINATION
Ethics committees of NT Department of Health, Menzies, WA Department of Health and WA Aboriginal Health approved the study. Results will be presented to communities, at conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT01735084.",2020,"Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible.","['Australian Aboriginal children', '270 Aboriginal children at 12 months of age to a booster dose of either', 'infants are 18\u2009months of age are as follows: (a) IgG geometric mean concentration (GMC) and proportion with IgG ≥100 EU/mL for protein D, and (b) IgG GMC and the proportion with IgG ≥0.35\u2009µg/mL for pneumococcal serotypes 3, 6A and 19A. Secondary immunogenicity comparisons of six primary and booster dose schedules of 10 shared serotypes at 18 months of age, nasopharyngeal carriage, all forms of otitis media, hearing loss and developmental milestones at 18, 24, 30 and 36 months of age will be reported']","['13-valent pneumococcal conjugate vaccine (PCV13', 'Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi', 'PHiD-CV10 or PCV13', '10-Valent pneumococcal non-typeable H. influenzae protein D conjugate vaccine (PHiD-CV10) versus 13-valent pneumococcal conjugate vaccine (PCV13']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532292', 'cui_str': 'Ehrlich units/milliliter'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0029882', 'cui_str': 'Otitis media'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C1864445', 'cui_str': 'Histiocytosis-lymphadenopathy plus syndrome'}, {'cui': 'C0450819', 'cui_str': 'CV10'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]",[],270.0,0.230418,"Children who completed the three-dose primary course schedules of PHiD-CV10 at 2, 4, 6 months of age; PCV13 at 2, 4, 6 months of age; or a combination schedule of PHiD-CV10 at 1, 2, 4 months of age plus PCV13 at 6 months of age are eligible.","[{'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Oguoma', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mulholland', 'Affiliation': 'Infection and Immunity: Pneumococcal Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Mathuram', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Center American Indian Health, John Hopkins School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Torzillo', 'Affiliation': 'Respiratory Medicine, Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McIntyre', 'Affiliation': 'Director, National Centre for Immunisation Research and Surveillance, Sydney, New South Wales, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Smith-Vaughan', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Balloch', 'Affiliation': 'Pneumococcal Immunology, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chatfield', 'Affiliation': 'Cerebral Palsy and Rehabilitation Research Centre, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lehmann', 'Affiliation': 'Division of Population Sciences, Telethon Institute for Child Health Research, West Perth, Western Australia, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Binks', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Director, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Krause', 'Affiliation': 'Centre for Disease Control, Department of Health, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Snelling', 'Affiliation': 'Infectious Disease Implementation Research Team, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Licciardi', 'Affiliation': 'Infections and Immunity: Pneumococcal Research, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Morris', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Amanda Jane', 'Initials': 'AJ', 'LastName': 'Leach', 'Affiliation': 'Child Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia amanda.leach@menzies.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-033511']
2990,32448796,Study protocol for the antidepressant advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care: a feasibility study.,"INTRODUCTION
The Antidepressant Advisor Study is a feasibility trial of a computerised decision-support tool which uses an algorithm to provide antidepressant treatment guidance for general practitioners (GPs) in the UK primary care service. The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.
METHODS AND ANALYSIS
The study is a parallel group, cluster-randomised controlled feasibility trial where participants are blind to treatment allocation. GPs were assigned to two treatment arms: (1) treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices. The study will assess recruitment and lost to follow-up rates, GP satisfaction with the tool and impact on health service use. A meaningful long-term roll-out unit cost will be calculated for the tool, and service use data will be collected at baseline and follow-up to inform a full economic evaluation of a future trial.
ETHICS AND DISSEMINATION
The study has received National Health Service ethical approval from the London-Camberwell St Giles Research Ethics Committee (ref: 17/LO/2074). The trial was pre-registered in the Clinical Trials.gov registry. The results of the study will be published in a pre-publication archive within 1 year of completion of the last follow-up assessment.
TRIAL REGISTRATION NUMBER
NCT03628027.",2020,"The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.
","['depression in UK primary care', 'general practitioners (GPs) in the UK primary care service']","['treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices', 'antidepressant advisor (ADeSS']",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",[],,0.105514,"The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.
","[{'ForeName': 'Phillippa', 'Initials': 'P', 'LastName': 'Harrison', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Carr', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Diede', 'Initials': 'D', 'LastName': 'Fennema', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barrett', 'Affiliation': ""Department of Health Services & Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK Roland.zahn@kcl.ac.uk.""}]",BMJ open,['10.1136/bmjopen-2019-035905']
2991,32453346,"Effects of a Workplace Wellness Program on Employee Health, Health Beliefs, and Medical Use: A Randomized Clinical Trial.","Importance
Many employers use workplace wellness programs to improve employee health and reduce medical costs, but randomized evaluations of their efficacy are rare.
Objective
To evaluate the effect of a comprehensive workplace wellness program on employee health, health beliefs, and medical use after 12 and 24 months.
Design, Setting, and Participants
This randomized clinical trial of 4834 employees of the University of Illinois at Urbana-Champaign was conducted from August 9, 2016, to April 26, 2018. Members of the treatment group (n = 3300) received incentives to participate in the workplace wellness program. Members of the control group (n = 1534) did not participate in the wellness program. Statistical analysis was performed on April 9, 2020.
Interventions
The 2-year workplace wellness program included financial incentives and paid time off for annual on-site biometric screenings, annual health risk assessments, and ongoing wellness activities (eg, physical activity, smoking cessation, and disease management).
Main Outcomes and Measures
Measures taken at 12 and 24 months included clinician-collected biometrics (16 outcomes), administrative claims related to medical diagnoses (diabetes, hypertension, and hyperlipidemia) and medical use (office visits, inpatient visits, and emergency department visits), and self-reported health behaviors and health beliefs (14 outcomes).
Results
Among the 4834 participants (2770 women; mean [SD] age, 43.9 [11.3] years), no significant effects of the program on biometrics, medical diagnoses, or medical use were seen after 12 or 24 months. A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002). The intervention significantly improved a set of employee health beliefs on average: participant beliefs about their chance of having a body mass index greater than 30, high cholesterol, high blood pressure, and impaired glucose level jointly decreased by 0.07 SDs (95% CI, -0.12 to -0.01 SDs; P = .02); however, effects on individual belief measures were not significant.
Conclusions and Relevance
This randomized clinical trial showed that a comprehensive workplace wellness program had no significant effects on measured physical health outcomes, rates of medical diagnoses, or the use of health care services after 24 months, but it increased the proportion of employees reporting that they have a primary care physician and improved employee beliefs about their own health.
Trial Registration
American Economic Association Randomized Controlled Trial Registry number: AEARCTR-0001368.",2020,A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002).,"['4834 participants (2770 women; mean [SD] age, 43.9 [11.3] years', '4834 employees of the University of Illinois at Urbana-Champaign was conducted from August 9, 2016, to April 26, 2018']","['incentives to participate in the workplace wellness program', 'Workplace Wellness Program', 'comprehensive workplace wellness program']","['physical health outcomes, rates of medical diagnoses, or the use of health care services', 'employee health beliefs on average: participant beliefs about their chance of having a body mass index greater than 30, high cholesterol, high blood pressure, and impaired glucose level jointly', 'proportion of employees', 'biometrics, medical diagnoses, or medical use', 'employee health, health beliefs, and medical use', 'Employee Health, Health Beliefs, and Medical Use', 'clinician-collected biometrics (16 outcomes), administrative claims related to medical diagnoses (diabetes, hypertension, and hyperlipidemia) and medical use (office visits, inpatient visits, and emergency department visits), and self-reported health behaviors and health beliefs (14 outcomes', 'financial incentives and paid time off for annual on-site biometric screenings, annual health risk assessments, and ongoing wellness activities (eg, physical activity, smoking cessation, and disease management']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0079272', 'cui_str': 'Employee Health'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0679809', 'cui_str': 'Health Risk Assessment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",4834.0,0.0185591,A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002).,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Reif', 'Affiliation': 'Department of Finance, University of Illinois at Urbana-Champaign.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'National Bureau of Economic Research, Cambridge, Massachusetts.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'National Bureau of Economic Research, Cambridge, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Payne', 'Affiliation': 'Department of Recreation, Sport and Tourism, University of Illinois at Urbana-Champaign.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Molitor', 'Affiliation': 'Department of Finance, University of Illinois at Urbana-Champaign.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1321']
2992,32453368,Effect of Antihypertensive Medication Reduction vs Usual Care on Short-term Blood Pressure Control in Patients With Hypertension Aged 80 Years and Older: The OPTIMISE Randomized Clinical Trial.,"Importance
Deprescribing of antihypertensive medications is recommended for some older patients with polypharmacy and multimorbidity when the benefits of continued treatment may not outweigh the harms.
Objective
This study aimed to establish whether antihypertensive medication reduction is possible without significant changes in systolic blood pressure control or adverse events during 12-week follow-up.
Design, Setting, and Participants
The Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE) study was a randomized, unblinded, noninferiority trial conducted in 69 primary care sites in England. Participants, whose primary care physician considered them appropriate for medication reduction, were aged 80 years and older, had systolic blood pressure lower than 150 mm Hg, and were receiving at least 2 antihypertensive medications were included. Participants enrolled between April 2017 and September 2018 and underwent follow-up until January 2019.
Interventions
Participants were randomized (1:1 ratio) to a strategy of antihypertensive medication reduction (removal of 1 drug [intervention], n = 282) or usual care (control, n = 287), in which no medication changes were mandated.
Main Outcomes and Measures
The primary outcome was systolic blood pressure lower than 150 mm Hg at 12-week follow-up. The prespecified noninferiority margin was a relative risk (RR) of 0.90. Secondary outcomes included the proportion of participants maintaining medication reduction and differences in blood pressure, frailty, quality of life, adverse effects, and serious adverse events.
Results
Among 569 patients randomized (mean age, 84.8 years; 276 [48.5%] women; median of 2 antihypertensive medications prescribed at baseline), 534 (93.8%) completed the trial. Overall, 229 (86.4%) patients in the intervention group and 236 (87.7%) patients in the control group had a systolic blood pressure lower than 150 mm Hg at 12 weeks (adjusted RR, 0.98 [97.5% 1-sided CI, 0.92 to ∞]). Of 7 prespecified secondary end points, 5 showed no significant difference. Medication reduction was sustained in 187 (66.3%) participants at 12 weeks. Mean change in systolic blood pressure was 3.4 mm Hg (95% CI, 1.1 to 5.8 mm Hg) higher in the intervention group compared with the control group. Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).
Conclusions and Relevance
Among older patients treated with multiple antihypertensive medications, a strategy of medication reduction, compared with usual care, was noninferior with regard to systolic blood pressure control at 12 weeks. The findings suggest antihypertensive medication reduction in some older patients with hypertension is not associated with substantial change in blood pressure control, although further research is needed to understand long-term clinical outcomes.
Trial Registration
EudraCT Identifier: 2016-004236-38; ISRCTN identifier: 97503221.",2020,"Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).
","['older patients with hypertension', 'Participants, whose primary care physician considered them appropriate for medication reduction, were aged 80 years and older, had systolic blood pressure lower than 150 mm Hg, and were receiving at least 2 antihypertensive medications were included', 'older patients with polypharmacy and multimorbidity', 'Patients With Hypertension Aged 80 Years and Older', '569 patients randomized (mean age, 84.8 years; 276 [48.5%] women', '69 primary care sites in England', 'older patients treated with multiple antihypertensive medications', 'Participants enrolled between April 2017 and September 2018 and underwent follow-up until January 2019']","['antihypertensive medication reduction (removal of 1 drug [intervention], n\u2009=\u2009282) or usual care (control, n\u2009=\u2009287), in which no medication changes were mandated', 'Antihypertensive Medication Reduction vs Usual Care', 'antihypertensive medications']","['Medication reduction', 'serious adverse event', 'systolic blood pressure control or adverse events', 'systolic blood pressure', 'proportion of participants maintaining medication reduction and differences in blood pressure, frailty, quality of life, adverse effects, and serious adverse events', 'Mild Systolic Hypertension']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension'}]",569.0,0.108474,"Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).
","[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Sheppard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Burt', 'Affiliation': 'The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lown', 'Affiliation': 'Primary Care Research Group, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Temple', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rosalyn', 'Initials': 'R', 'LastName': 'Fraser', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Radcliffe Department of Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Heneghan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'F D Richard', 'Initials': 'FDR', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Shahela', 'Initials': 'S', 'LastName': 'Kodabuckus', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care Population Sciences and Medical Education Unit, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mollison', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rupert A', 'Initials': 'RA', 'LastName': 'Payne', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Marney', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Patient and public involvement representative, London, United Kingdom.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.4871']
2993,32453369,Effect of Doxycycline on Aneurysm Growth Among Patients With Small Infrarenal Abdominal Aortic Aneurysms: A Randomized Clinical Trial.,"Importance
Abdominal aortic aneurysms affect more than 3% of US older adults.
Objective
To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter.
Design, Setting, and Participants
Parallel, 2-group, randomized clinical trial that was conducted at 22 US clinical centers between May 2013 and January 2017, and enrolled patients 50 years or older with small (3.5-5.0 cm for men, 3.5-4.5 cm for women) infrarenal aneurysms. The final date of follow-up was July 31, 2018.
Interventions
Patients were randomized to receive twice daily for 2 years doxycycline 100 mg orally (as capsules) (n = 133) or placebo (n = 128).
Main Outcomes and Measures
The primary outcome was change in abdominal aortic aneurysm maximum transverse diameter measured from CT images at baseline and follow-up at 2 years. Patients were assigned ranks based on the maximum transverse diameter (measured or imputed) of the aorta and also if they underwent aneurysm repair or died. The ranks were converted to scores having a normal distribution to facilitate the primary analysis (""normal scores"").
Results
Of 261 patients randomized, no follow-up CT scans were obtained on 7 (3%), leaving a final analysis set of 129 patients assigned to doxycycline and 125 to placebo (mean [SD] age, 71.0 years [7.4 years], 35 women [14%]). The outcome normal scores used in the primary analysis were based on maximum transverse diameter (measured or imputed) in 113 patients (88%) in the doxycycline group and 112 patients (90%) in the placebo group; aneurysm repair in 13 (10%) and 9 (7%), and death in 3 (2%) and 4 (3%), respectively. The primary outcome, normal scores reflecting change in aortic diameter, did not differ significantly between the 2 groups, mean change in normal scores, 0.0262 vs -0.0258 (1-sided P = .71). Mean (SD) baseline maximum transverse diameter was 4.3 cm (0.4 cm) for doxycycline and 4.3 cm (0.4 cm) for placebo. At the 2-year follow-up, the change in measured maximum transverse diameter was 0.36 cm (95% CI, 0.31 to 0.40 cm) for 96 patients in the doxycycline group vs 0.36 cm (95% CI, 0.30 to 0.41 cm) for 101 patients in the placebo group (difference, 0.0; 95% CI, -0.07 to 0.07 cm; 2-sided P = .93). No patients were withdrawn from the study because of adverse effects. Joint pain occurred in 84 of 129 patients (65%) with doxycycline and 79 of 125 (63%) with placebo.
Conclusions and Relevance
Among patients with small infrarenal abdominal aortic aneurysms, doxycycline compared with placebo did not significantly reduce aneurysm growth at 2 years. These findings do not support the use of doxycycline for reducing the growth of small abdominal aortic aneurysms.
Trial Registration
ClinicalTrials.gov Identifier: NCT01756833.",2020,"To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter.
","['22 US clinical centers between May 2013 and January 2017, and enrolled patients 50 years or older with small (3.5-5.0 cm for men, 3.5-4.5 cm for women) infrarenal aneurysms', 'Patients With Small Infrarenal Abdominal Aortic Aneurysms', 'patients with small infrarenal abdominal aortic aneurysms', '261 patients randomized']","['Doxycycline', 'doxycycline 100 mg orally (as capsules', 'doxycycline', 'placebo']","['Joint pain', 'maximum transverse diameter', 'growth of abdominal aortic aneurysm', 'death', 'mean change in normal scores', 'normal scores reflecting change in aortic diameter', 'change in abdominal aortic aneurysm maximum transverse diameter measured from CT images', 'Mean (SD) baseline maximum transverse diameter', 'aneurysm repair', 'aneurysm growth']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0579133', 'cui_str': 'Aortic diameter'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]",261.0,0.567673,"To test whether doxycycline reduces the growth of abdominal aortic aneurysm over 2 years as measured by maximum transverse diameter.
","[{'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Baxter', 'Affiliation': 'Department of Surgery, University of Nebraska School of Medicine, Omaha.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Matsumura', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Curci', 'Affiliation': 'Department of Surgery, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': 'Axio Research, LLC, Seattle, Washington.'}, {'ForeName': 'LuAnn', 'Initials': 'L', 'LastName': 'Larson', 'Affiliation': 'Department of Surgery, University of Nebraska School of Medicine, Omaha.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Blackwelder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lam', 'Affiliation': 'Genentech, Oakland, California.'}, {'ForeName': 'Marniker', 'Initials': 'M', 'LastName': 'Wijesinha', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.5230']
2994,32464351,Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.,"BACKGROUND AND PURPOSE
Several studies have indicated that altered serotonergic neurotransmission may contribute to the motor features commonly associated with Parkinson's disease (PD) drug treatment such as levodopa-induced dyskinesias (LIDs). 5-Hydroxytryptophan (5-HTP) is the immediate precursor of serotonin. We have recently demonstrated that 5-HTP produces significant antidyskinetic effects in a rat model of PD. To date, there has been inconsistent research on the use of 5-HTP in PD. The purpose of this study was to compare the effects of 5-HTP versus placebo on levodopa-induced motor complications in PD patients.
MATERIAL AND METHODS
A single-center, randomized, double-blind placebo-controlled cross-over study was performed. A total of 12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol. Patients received placebo or 50 mg of 5-HTP daily in a cross-over design over a period of 4 weeks. For the assessment of efficacy on the motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries were obtained at baseline and weeks 4, 8, 12 and 16 (T-end).
RESULTS
Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
CONCLUSIONS
This study provides preliminary evidence of clinical benefit of 5-HTP against LIDs in PD. Larger studies with a longer treatment duration and a wider range of doses are warranted to corroborate these findings.",2020,"RESULTS
Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","['PD patients', ""Parkinson's disease"", '12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol']","['5-Hydroxytryptophan', '5-HTP versus placebo', '5-Hydroxytryptophan (5-HTP', '5-HTP', 'placebo or 50\xa0mg of 5-HTP', '5-HTP against LIDs', 'placebo']","['UDysRS and UPDRS-IV scores', 'Efficacy and safety', 'motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries', 'LIDs']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.222511,"RESULTS
Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. Electronic address: mario.meloni@hotmail.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Puligheddu', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Sanna', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannas', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Farris', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tronci', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Figorilli', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Defazio', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116869']
2995,32464420,Whole egg consumption increases plasma choline and betaine without affecting TMAO levels or gut microbiome in overweight postmenopausal women.,"As a crucial part of the symbiotic system, the gut microbiome is metabolically connected to many diseases and conditions, including cardiovascular diseases (CVD). Trimethylamine (TMA) is produced by gut bacteria from dietary choline, betaine, or L-carnitine, and is then converted in the liver to Trimethylamine N-oxide (TMAO), which in turn affects hepatic and intestinal lipid metabolism. Circulating TMAO is positively associated with CVD risk. Because eggs are rich in choline, it has been speculated that their consumption may increase plasma TMAO. In this study, we hypothesized that 2 eggs per day increases plasma TMAO level by altering gut microbiome composition in mildly hypercholesterolemic postmenopausal women. In this randomized, cross-over study, 20 overweight, postmenopausal women were given 2 whole eggs and the equivalent amount of yolk-free substitute as breakfast for 4 weeks, in randomized order, with a 4-week washout in between. Fasting blood draws and stool were collected at the beginning and end of each treatment period. Plasma TMAO, choline, betaine and other metabolites were analyzed using LC/MS, while gut microbiome composition was analyzed using 16S amplicon sequencing. Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments. Gut microbiome composition showed large inter-individual variability at baseline and in response to the treatments. The consumption of 2 eggs per day in overweight, postmenopausal mildly hypercholesterolemic women significantly increased plasma choline and betaine, but did not increase plasma TMAO or alter gut microbiome composition.",2020,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","['mildly hypercholesterolemic postmenopausal women', 'overweight postmenopausal women', '20 overweight, postmenopausal women']",['Trimethylamine (TMA'],"['plasma TMAO', 'plasma TMAO level', 'Plasma TMAO, choline, betaine and other metabolites', 'Plasma choline and betaine', 'Fasting blood draws and stool', 'TMAO level', 'plasma choline and betaine', 'plasma TMAO or alter gut microbiome composition']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0077172', 'cui_str': 'trimethylamine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0381708,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bardagjy', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: asteve@ucdavis.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: xctang@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: romisacchi@gmail.com.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Randolph', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: jmrandolph@ucdavis.edu.'}, {'ForeName': 'Francene M', 'Initials': 'FM', 'LastName': 'Steinberg', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: fmsteinberg@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.04.002']
2996,32471910,Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial.,"OBJECTIVE
Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system.
RESEARCH DESIGN AND METHODS
After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14-72 years; mean HbA 1c , 7.1% [54 mmol/mol]) were randomly assigned to CLC ( N = 54, Control-IQ) or PLGS ( N = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70-180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study.
RESULTS
All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC versus 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI: 3.6, 8.3%; P < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = -6.0%; 95% CI: -8.4, -3.7%; P < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI: -0.05, 0.13%; P = 0.41). HbA 1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] versus 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol]; 95% CI: -0.57 [-6.2 mmol/mol], -0.11% [1.2 mmol/mol]; P = 0.0035).
CONCLUSIONS
Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA 1c toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.",2020,HbA 1c after 13 weeks was lower on CLC than PLGS (,"['Type 1 Diabetes', 'All 109 participants completed the study', '109 participants with type 1 diabetes (age range, 14-72 years; mean HbA 1c , 7.1% [54 mmol/mol']","['CLC', 'CLC Versus PLGS', 'closed-loop control (CLC) system', 'CLC system', 'PLGS']","['continuous glucose monitor (CGM)-measured time in range (TIR', 'Mean ± SD TIR', 'TIR and increased HbA 1c toward their pre-CLC values, while hypoglycemia']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",109.0,0.176696,HbA 1c after 13 weeks was lower on CLC than PLGS (,"[{'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': ''}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': ''}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': ''}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': ''}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': ''}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': ''}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': ''}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ambler-Osborn', 'Affiliation': ''}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': ''}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': ''}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': ''}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Levister', 'Affiliation': ''}, {'ForeName': 'Vinaya', 'Initials': 'V', 'LastName': 'Simha', 'Affiliation': ''}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kollman', 'Affiliation': ''}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Lum', 'Affiliation': ''}, {'ForeName': 'Boris P', 'Initials': 'BP', 'LastName': 'Kovatchev', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-0124']
2997,32471973,The neuropeptide substance P regulates aldosterone secretion in human adrenals.,"Aldosterone, produced by the adrenals and under the control of plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure. Here we report that the neuropeptide substance P (SP) released by intraadrenal nerve fibres, stimulates aldosterone secretion via binding to neurokinin type 1 receptors (NK1R) expressed by aldosterone-producing adrenocortical cells. The action of SP is mediated by the extracellular signal-regulated kinase pathway and involves upregulation of steroidogenic enzymes. We also conducted a prospective proof-of-concept, double blind, placebo-controlled clinical trial aimed to investigate the impact of the NK1R antagonist aprepitant on aldosterone secretion in healthy male volunteers (EudraCT: 2008-003367-40, ClinicalTrial.gov: NCT00977223). Participants received during two 7-day treatment periods aprepitant (125 mg on the 1 st day and 80 mg during the following days) or placebo in a random order at a 2-week interval. The primary endpoint was plasma aldosterone levels during posture test. Secondary endpoints included basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH during the three different stimulatory tests. The safety of the treatment was assessed on the basis of serum transaminase measurements on days 4 and 7. All pre-specified endpoints were achieved. Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture. These results indicate that the autonomic nervous system exerts a direct stimulatory tone on mineralocorticoid synthesis through SP, and thus plays a role in the maintenance of hydromineral homeostasis. This regulatory mechanism may be involved in aldosterone excess syndromes.",2020,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"['healthy male volunteers (EudraCT', 'human adrenals']","['NK1R antagonist aprepitant', 'Aldosterone', 'neuropeptide substance P (SP', 'placebo']","['plasma aldosterone levels', 'aldosterone secretion', 'aldosterone production', 'plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure', 'basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}]","[{'cui': 'C0038581', 'cui_str': 'Neurokinin alpha'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1272143', 'cui_str': 'Plasma aldosterone level'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}]",,0.0620632,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Wils', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Duparc', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Cailleux', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Antoine-Guy', 'Initials': 'AG', 'LastName': 'Lopez', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Guiheneuf', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutelet', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hadrien-Gaël', 'Initials': 'HG', 'LastName': 'Boyer', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dubessy', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Saloua', 'Initials': 'S', 'LastName': 'Cherifi', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cauliez', 'Affiliation': 'Rouen University Hospital, Department of Biochemistry, 76000, Rouen, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Gobet', 'Affiliation': 'Rouen University Hospital, Department of Pathology, 76000, Rouen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Defortescu', 'Affiliation': 'Rouen University Hospital, Department of Urology, 76000, Rouen, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Ménard', 'Affiliation': 'Rouen University Hospital, Department of Biostatistics, 76000, Rouen, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Louiset', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lefebvre', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France. herve.lefebvre@chu-rouen.fr.'}]",Nature communications,['10.1038/s41467-020-16470-8']
2998,32472001,Olaparib monotherapy for Asian patients with a germline BRCA mutation and HER2-negative metastatic breast cancer: OlympiAD randomized trial subgroup analysis.,"The OlympiAD Phase III study (NCT02000622) established the clinical benefits of olaparib tablet monotherapy (300 mg twice daily) over chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA1/2 mutation (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who had received ≤2 chemotherapy lines in the metastatic setting. Here, we report pre-specified analyses of data from Asian (China, Japan, Korea and Taiwan) patients in the study. All patients were randomized 2:1 to olaparib tablets (300 mg twice daily) or single-agent chemotherapy TPC (21-day cycles of either capecitabine, eribulin or vinorelbine). The primary endpoint was progression-free survival assessed by blinded independent central review. The prevalence of gBRCAm in the OlympiAD Asian subgroup screened for study recruitment was 13.5%. Patient demographics and disease characteristics of the Asian subgroup (87/302 patients) were generally well balanced between treatment arms. Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population. Findings on secondary efficacy and safety/tolerability outcome measures in Asian patients were also similar to those observed in the global OlympiAD study population. The OlympiAD study was not powered to detect race-related differences between treatment groups; however, the consistency of our findings with the global OlympiAD study population suggests that previously reported findings are generalizable to Asian patients.",2020,"Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population.","['Asian patients with a germline BRCA mutation and HER2-negative metastatic breast cancer', 'patients with a germline BRCA1/2 mutation (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who had received ≤2 chemotherapy lines in the metastatic setting', 'Asian (China, Japan, Korea and Taiwan) patients in the study', 'Asian patients']","['olaparib tablet monotherapy', ""chemotherapy treatment of physician's choice (TPC"", 'olaparib tablets (300\u2009mg twice daily) or single-agent chemotherapy TPC (21-day cycles of either capecitabine, eribulin or vinorelbine', 'Olaparib monotherapy']","['secondary efficacy and safety/tolerability outcome measures', 'progression-free survival', 'longer median progression-free survival']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4520027', 'cui_str': 'olaparib Oral Tablet'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.177673,"Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population.","[{'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea. moisa@snu.ac.kr.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/National Clinical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': 'Medical Oncology Center, Hunan Tumor Hospital, Changsha, China.'}, {'ForeName': 'Dah-Cherng', 'Initials': 'DC', 'LastName': 'Yeh', 'Affiliation': 'Cheng Ching Hospital, Taichung City, Taiwan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Aichi, Japan.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Hyuk', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ling-Ming', 'Initials': 'LM', 'LastName': 'Tseng', 'Affiliation': 'Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-020-63033-4']
2999,32472801,Prophylactic Intrathecal Morphine and Prevention of Post-Dural Puncture Headache: A Randomized Double-blind Trial: Erratum.,,2020,,['Post-Dural Puncture Headache'],['Prophylactic Intrathecal Morphine'],[],"[{'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.674421,,[],Anesthesiology,['10.1097/ALN.0000000000003411']
3000,32469850,General concepts in biostatistics and clinical epidemiology: Experimental studies with randomized clinical trial design.,"In experimental studies, researchers apply an intervention to a group of study participants and analyze the effects over a future or prospective timeline. The prospective nature of these types of studies allows for the determination of causal relationships, but the interventions they are based on require rigorous bioethical evaluation, approval from an ethics committee, and registration of the study protocol prior to implementation. Experimental research includes clinical and preclinical testing of a novel intervention or therapy at different phases of development. The main objective of clinical trials is to evaluate an interventions efficacy and safety. Conventional clinical trials are blinded, randomized, and controlled, meaning that participants are randomly assigned to either the study intervention group or a comparator (a control group exposed to a placebo intervention or another non-placebo or active interventionor not exposed to any intervention) to reduce selection and confounding biases, and researchers are also unaware of the type of intervention being applied. Intention-to-treat analysis (inclusion of all originally randomized subjects) should be done to avoid the effects of attrition (dropout) and crossover (variance in the exposure or treatment over time). A quasi-experimental design and external controls may also be used. Metrics used to measure the magnitude of effects include relative risk, absolute and relative risk reductions, and numbers needed to treat and harm. Confounding factors are controlled by randomization. Other types of bias to consider are selection, performance, detection, and reporting. This review is the fifth of a methodological series on general concepts in biostatistics and clinical epidemiology developed by the Chair of Scientific Research Methodology at the School of Medicine, University of Valparaíso, Chile. It describes general theoretical concepts related to randomized clinical trials and other experimental studies in humans, including fundamental elements, historical development, bioethical issues, structure, design, association measures, biases, and reporting guidelines. Factors that should be considered in the execution and evaluation of a clinical trial are also covered.",2020,Intention-to-treat analysis (inclusion of all originally randomized subjects) should be done to avoid the effects of attrition (dropout) and crossover (variance in the exposure or treatment over time).,['biostatistics and clinical epidemiology'],['placebo intervention or another non-placebo or active interventionor not exposed to any intervention'],"['relative risk, absolute and relative risk reductions, and numbers needed to treat and harm']","[{'cui': 'C0005544', 'cui_str': 'Biometry'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}]",,0.0875989,Intention-to-treat analysis (inclusion of all originally randomized subjects) should be done to avoid the effects of attrition (dropout) and crossover (variance in the exposure or treatment over time).,"[{'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Estrada', 'Affiliation': 'Cátedra de Metodología de la Investigación Científica, Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Arancibia', 'Affiliation': 'Cátedra de Metodología de la Investigación Científica, Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile; Centro Interdisciplinario de Estudios en Salud (CIESAL), Universidad de Valparaíso, Valparaíso, Chile.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Stojanova', 'Affiliation': 'Cátedra de Metodología de la Investigación Científica, Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile; Centro Interdisciplinario de Estudios en Salud (CIESAL), Universidad de Valparaíso, Valparaíso, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Papuzinski', 'Affiliation': 'Cátedra de Metodología de la Investigación Científica, Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile; Centro Interdisciplinario de Estudios en Salud (CIESAL), Universidad de Valparaíso, Valparaíso, Chile.'}]",Medwave,['10.5867/medwave.2020.02.7869']
3001,32469870,"Effect of a nutrient-rich, food-based supplement given to rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes: A randomized controlled trial.","Obtaining a nutrient-rich diet during pregnancy is a challenge for pregnant women living in low-income countries. This randomized, controlled trial was designed to determine if a freshly prepared food supplement from local animal-source foods and dark-green leafy vegetables given prior to and/or during pregnancy improved birth outcomes in rural Vietnamese women. Primiparous women, 18 to 30 years of age, who participated in the study were assigned to one of three groups: PC-T women received the supplement from pre-conception to term, MG-T women received the supplement from mid-gestation to term, and the RPC women received routine prenatal care. Supplement intake was observed and quantified. Infant anthropometry was measured at birth and/or within seven days of delivery. The effect of the intervention on maternal and birth outcomes was determined using linear regression modeling. Of the 460 women enrolled in the study, 317 women completed the study. Those not completing the study had either moved from the area, did not conceive within 12 months of study enrollment, or miscarried. The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups. However, it failed to alter infant anthropometric measurements at birth. In the entire cohort, maternal gestational weight gain was greater in women with a low pre-pregnancy BMI (<18.5) and in women with a higher educational attainment. Working as a farmer reduced gestational weight gain but it did not affect birth weight or length. In summary, a nutrient-rich, food-based supplement given to rural Vietnamese women from pre-conception to term or mid-gestation to term did not affect maternal or infant outcomes. The low weight gains, possibly due to demanding farm work done throughout the reproductive cycle, may have obviated any effects of the low energy, nutrient-rich food supplement on birth outcomes. Trial registration : Registered Clinical Trials.gov: NCT01235767.",2020,"The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups.","['rural Vietnamese women', 'pregnant women living in low-income countries', 'Primiparous women, 18 to 30 years of age, who participated in the study', 'rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes', '460 women enrolled in the study, 317 women completed the study']","['freshly prepared food supplement from local animal-source foods and dark-green leafy vegetables', 'nutrient-rich, food-based supplement', 'nutrient-rich diet', 'PC-T women received the supplement from pre-conception to term, MG-T women received the supplement from mid-gestation to term, and the RPC women received routine prenatal care']","['protein, iron, zinc, folate, vitamin A and B12 intakes', 'maternal gestational weight gain', 'low weight gains', 'gestational weight gain', 'maternal and birth outcomes', 'birth weight or length']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C2348897', 'cui_str': 'Green leafy vegetable'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0231246', 'cui_str': 'Failure to gain weight'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",317.0,0.162934,"The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups.","[{'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Chaffee', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Nguyen T', 'Initials': 'NT', 'LastName': 'Diep Anh', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, United States of America.""}]",PloS one,['10.1371/journal.pone.0232197']
3002,32469881,"Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial.","BACKGROUND
Distal radius fractures are common fractures and the cornerstone of treatment remains immobilization of the wrist in a cast. At present, there is a scarcity of studies that compare different cast immobilization methods. The objective of the study was therefore to compare volar-flexion and ulnar deviation cast to functional cast position in the treatment of dorsally displaced distal radius fracture among elderly patients.
METHODS AND FINDINGS
We performed a pragmatic, randomized, controlled trial in three emergency centers in Finland. After closed reduction of the fracture, the wrist was placed in either volar-flexion and ulnar deviation cast or functional cast position. The follow-up was 12 months. The primary outcome was patient-rated wrist evaluation (PRWE) score at 12 months. The secondary outcomes were Quick-DASH score, grip strength, health-related quality of life (15D), and pain catastrophizing scale. The number of complications was also recorded. In total, 105 participants were included in the study. Of these, 88% were female and the mean age was 73.5 (range 65-94) years. In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9 (95% CI: -13.1.- 3.4., p = .24) in favor of the functional cast position. Operative treatment due to loss of reduction of fracture was performed for four patients (8%) in the FC group and for seven patients (13%) in the volar-flexion and ulnar deviation cast group (OR: 0.63, 95% CI: 0.16-2.1).
CONCLUSION
In this study, the data were consistent with a wide range of treatment effects when comparing two different cast positions in the treatment of distal radius fracture among elderly patients at 12-month follow-up. However, the functional cast is more likely to be superior when compared to volar-flexion and ulnar deviation cast.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02894983 Accessible: https://clinicaltrials.gov/ct2/show/NCT02894983.",2020,"In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9","['88% were female and the mean age was 73.5 (range 65-94) years', 'dorsally displaced distal radius fracture among elderly patients', '105 participants were included in the study', ""patients with Colles' fracture"", 'three emergency centers in Finland']",['volar-flexion and ulnar deviation cast to functional cast position'],"['Quick-DASH score, grip strength, health-related quality of life (15D), and pain catastrophizing scale', 'patient-rated wrist evaluation (PRWE) score', 'patient-rated wrist evaluation measure', 'number of complications', 'reduction of fracture', 'distal radius fracture']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009353', 'cui_str': ""Colles' fracture""}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0449752', 'cui_str': 'Ulnar deviation'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",105.0,0.170183,"In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9","[{'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Raittio', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Antti P', 'Initials': 'AP', 'LastName': 'Launonen', 'Affiliation': 'Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Hevonkorpi', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Luokkala', 'Affiliation': 'Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kukkonen', 'Affiliation': 'Satakunta Central Hospital, Pori, Finland.'}, {'ForeName': 'Aleksi', 'Initials': 'A', 'LastName': 'Reito', 'Affiliation': 'Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Minna K', 'Initials': 'MK', 'LastName': 'Laitinen', 'Affiliation': 'Division of Orthopaedics and Traumatology, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ville M', 'Initials': 'VM', 'LastName': 'Mattila', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}]",PloS one,['10.1371/journal.pone.0232153']
3003,32469893,Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial.,"INTRODUCTION
Intramuscular electroporation (IM/EP) is a vaccine delivery technique that improves the immunogenicity of DNA vaccines. We evaluated the acceptability and tolerability of electroporation among healthy African study participants.
METHODS
Forty-five participants were administered a DNA vaccine (HIV-MAG) or placebo by electroporation at three visits occurring at four week-intervals. At the end of each visit, participants were asked to rate pain at four times: (1) when the device was placed on the skin and vaccine injected, before the electrical stimulation, (2) at the time of electrical stimulation and muscle contraction, and (3) at 10 minutes and (4) 30 minutes after the procedure was completed. For analyses, pain level was dichotomized as either ""acceptable"" (none/slight/uncomfortable) or ""too much"" (Intense, severe, and very severe) and examined over time using repeated measures models. Optional brief comments made by participants were summarized anecdotally.
RESULTS
All 45 participants completed all three vaccination visits; none withdrew from the study due to the electroporation procedure. Most (76%) reported pain levels as acceptable at every time point across all vaccination visits. The majority of ""unacceptable"" pain was reported at the time of electrical stimulation. The majority of the participants (97%) commented that they preferred electroporation to standard injection.
CONCLUSION
Repeated intramuscular electroporation for vaccine delivery was found to be acceptable and feasible among healthy African HIV vaccine trial participants. The majority of participants reported an acceptable pain level at all vaccination time points. Further investigation may be warranted into the value of EP to improve immunization outcomes. ClinicalTrials.gov NCT01496989.",2020,The majority of participants reported an acceptable pain level at all vaccination time points.,"['All 45 participants completed all three vaccination visits; none withdrew from the study due to the electroporation procedure', 'Forty-five participants', 'healthy African participants', 'healthy African study participants', 'healthy African HIV vaccine trial participants']","['DNA vaccine (HIV-MAG) or placebo', 'repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine', 'Intramuscular electroporation (IM/EP']","['Acceptability and tolerability', 'acceptability and tolerability of electroporation', 'pain level', 'rate pain', 'pain levels', 'acceptable pain level']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0129439', 'cui_str': 'Myelin associate glycoprotein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0486959', 'cui_str': 'Human immunodeficiency virus DNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",45.0,0.16596,The majority of participants reported an acceptable pain level at all vaccination time points.,"[{'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Mpendo', 'Affiliation': 'Uganda Virus Research Institute-International AIDS Vaccine Initiative, HIV Vaccine Program, Entebbe, Uganda.'}, {'ForeName': 'Gaudensia', 'Initials': 'G', 'LastName': 'Mutua', 'Affiliation': 'Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Nanvubya', 'Affiliation': 'Uganda Virus Research Institute-International AIDS Vaccine Initiative, HIV Vaccine Program, Entebbe, Uganda.'}, {'ForeName': 'Omu', 'Initials': 'O', 'LastName': 'Anzala', 'Affiliation': 'Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Nyombayire', 'Affiliation': 'Project San Francisco (PSF), Kigali, Rwanda.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Karita', 'Affiliation': 'Project San Francisco (PSF), Kigali, Rwanda.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'EMMES Corporation, Rockville, Maryland, United States of America.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Hannaman', 'Affiliation': 'Ichor Medical Systems, Inc., San Diego, California, United States of America.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Fast', 'Affiliation': 'International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Priddy', 'Affiliation': 'International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.'}, {'ForeName': 'Huub C', 'Initials': 'HC', 'LastName': 'Gelderblom', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Hills', 'Affiliation': 'University of California at San Francisco, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0233151']
3004,32469906,"Training intervention to improve hygiene practices in Islamic boarding school in Yogyakarta, Indonesia: A mixed-method study.","BACKGROUND
The primary objective of this study was to determine the effect of a training intervention in overall improvement in students' (santris) knowledge, behavior, and outcome.
METHODS
A mixed-methods exploratory sequential design was applied. First, qualitative data were collected from three focus group discussions with 20 supervisors and one in-depth interview with school principal to explore current hygiene practices. The information was then used to develop training intervention using either video, poster, and leaflet. To measure the effect, a stepped wedge cluster design with pre- and post-test analyses was conducted. A total of 452 junior high school santris in one Islamic boarding school were non-randomly allocated to either three intervention groups. Outcome measures were knowledge, personal behavior, and room hygiene. Codes and categories were produced in the qualitative analysis, while paired t-tests and Wilcoxon rank tests test were used in the quantitative analysis.
RESULTS
The qualitative study identified poor practices on personal and room hygiene among the santris and proposed a training intervention. Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001). Room hygiene was significantly improved among boys and those who received leaflets.
CONCLUSION
Having developed a specific training materials, school-based hygiene training intervention improved knowledge and personal behavior. Its effect on room hygiene particularly for female santris needs further strengthening of the intervention in this Islamic boarding school setting.",2020,"Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001).","['Islamic boarding school in Yogyakarta, Indonesia', '452 junior high school santris in one Islamic boarding school']","['training intervention', 'Training intervention']","[""overall improvement in students' (santris) knowledge, behavior, and outcome"", 'knowledge and personal behavior', 'Room hygiene', 'knowledge, personal behavior, and room hygiene']","[{'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]",452.0,0.0218919,"Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001).","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Widyasari', 'Affiliation': 'International Health, Public Health Graduate Program, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Yayi Suryo', 'Initials': 'YS', 'LastName': 'Prabandari', 'Affiliation': 'Department of Health Behavior, Environment, and Social Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Utarini', 'Affiliation': 'Department of Health Policy and Management, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}]",PloS one,['10.1371/journal.pone.0233267']
3005,32469920,Actor feedback and rigorous monitoring: Essential quality assurance tools for testing behavioral interventions with simulation.,"INTRODUCTION
Simulation is a powerful tool for training and evaluating clinicians. However, few studies have examined the consistency of actor performances during simulation based medical education (SBME). The Simulated Communication with ICU Proxies trial (ClinicalTrials.gov NCT02721810) used simulation to evaluate the effect of a behavioral intervention on physician communication. The purpose of this secondary analysis of data generated by the quality assurance team during the trial was to assess how quality assurance monitoring procedures impacted rates of actor errors during simulations.
METHODS
The trial used rigorous quality assurance to train actors, evaluate performances, and ensure the intervention was delivered within a standardized environment. The quality assurance team evaluated video recordings and documented errors. Actors received both timely, formative feedback and participated in group feedback sessions.
RESULTS
Error rates varied significantly across three actors (H(2) = 8.22, p = 0.02). In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42).
CONCLUSIONS
Rigorous quality assurance procedures may help ensure consistent actor performances during SBME.",2020,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42).
",[],"['Actor feedback and rigorous monitoring', 'behavioral intervention']","['incidence of actor error over time, and errors', 'Error rates']",[],"[{'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0672195,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42).
","[{'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Abshire', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Pragyashree Sharma', 'Initials': 'PS', 'LastName': 'Basyal', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Teply', 'Affiliation': 'Division of Geriatrics, Gerontology, and Palliative Medicine, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, United States of America.'}, {'ForeName': 'Arun L', 'Initials': 'AL', 'LastName': 'Singh', 'Affiliation': ""Division of Pediatric Palliative Medicine, Prisma Health Children's Hopsital - Upstate, University of South Carolina School of Medicine - Greenville, Greenville, South Carolina, United States of America.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Hayes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PloS one,['10.1371/journal.pone.0233538']
3006,32469922,The Community Navigator Study: Results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression.,"BACKGROUND
Loneliness is common among people with mental health problems and predicts poorer recovery from depression and anxiety. Needs for support with loneliness and social relationships are often under-addressed in mental health services. The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services. Acceptability and feasibility of the programme and a trial evaluation were tested in a feasibility randomised controlled trial with qualitative evaluation.
METHODS
Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the Community Navigator programme over six months in addition to routine care (n = 30); or routine care (n = 10). Measures of loneliness, depression, other clinical and social outcomes and service use were collected at baseline and six-months follow-up. Levels of engagement in the programme and rates of trial recruitment and retention were assessed. Programme delivery was assessed through session logs completed by Community Navigators. The acceptability of the programme was explored through qualitative interviews (n = 32) with intervention group participants, their family and friends, programme providers and other involved staff.
RESULTS
Forty participants were recruited in four months from 65 eligible potential participants asked. No one withdrew from the trial. Follow-up interviews were completed with 35 participants (88%). Process records indicated the programme was delivered as intended: there was a median of seven meetings with their Community Navigator (of a maximum ten) per treatment group participant. Qualitative interviews indicated good acceptability of the programme to stakeholders, and potential utility in reducing loneliness and depression and anxiety.
CONCLUSIONS
A definitive, multi-site randomised controlled trial is recommended to evaluate the effectiveness and cost-effectiveness of the Community Navigator programme for people with complex anxiety and depression in secondary mental health services.",2020,The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services.,"['people with complex anxiety and depression in secondary mental health services', 'people with complex anxiety or depression', 'Forty participants were recruited in four months from 65 eligible potential participants asked', 'people with mental health problems', 'adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services', 'Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the']","['Community Navigator programme over six months in addition to routine care (n = 30); or routine care', 'Community Navigator programme']","['Acceptability and feasibility', 'loneliness and depression and anxiety', 'effectiveness and cost-effectiveness', 'loneliness, depression, other clinical and social outcomes and service use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",40.0,0.205116,The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services.,"[{'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Frerichs', 'Affiliation': 'The McPin Foundation, London, United Kingdom.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Stefanidou', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Pinfold', 'Affiliation': 'The McPin Foundation, London, United Kingdom.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Billings', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Barber', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Anjie', 'Initials': 'A', 'LastName': 'Chhapia', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Chipp', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Henderson', 'Affiliation': 'Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, United Kingdom.'}, {'ForeName': 'Prisha', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Shorten', 'Affiliation': 'Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giorgalli', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Terhune', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0233535']
3007,32469946,Training specificity performing single-joint vs. multi-joint resistance exercises among physically active females: A randomized controlled trial.,"Resistance-training of the lower limbs can be performed using exercises moving one (single-joint exercises) or several joints (multi-joint exercises). This study compared the effects of training one multi-joint exercise (leg press) or two single-joint exercises (leg extension and kickback) on dynamic and isometric strength and the transferability of dynamic strength between exercises. Fifty-three physically active women were randomized to a multi-joint (MJ) training group (age = 21.95±0.82 years, mass = 64.85±5.76 kg, height = 167.35±2.47 cm; n = 20), single-joint (SJ) training group (age = 22.56±1.66 years, mass = 64.85±5.76 kg, height = 165.94±2.84 cm; n = 18), or a control (CON) group (age = 21.27±0.68 years, mass = 68.43±4.86 kg, height = 168.63±2.84 cm; n = 15). The training groups participated in an 8-week supervised single- or multi-joint lower limb training consisting of 18 sessions. Pre- and post-training, six repetitions maximum (RM) and maximal voluntary isometric contraction in the three exercises were assessed, along with electromyography of the superficial quadriceps muscles. Improvements in all dynamic exercises were greatest after training the specific exercises (ES = 1.26-2.14, P<0.001-0.025) and all were greater in the training groups than in the CON group (ES = 1.43-3.31, P<0.001-0.021). The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002). However, leg press and leg extension strength improved similarly in the MJ group (ES = 0.54, P = 0.072). All strength and electromyographic measures remained unchanged in the CON group (ES = 0.00-0.44, P = 0.412-0.966). Improved dynamic strength in leg press, kickback and leg extension is best attained by training the specific exercises, but both training modalities can improve strength across all exercises.",2020,"The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002).","['group (age = 22.56±1.66 years, mass = 64.85±5.76 kg, height = 165.94±2.84 cm; n = 18), or a control (CON) group (age = 21.27±0.68 years, mass = 68.43±4.86 kg, height = 168.63±2.84 cm; n = 15', 'Fifty-three physically active women', 'group (age = 21.95±0.82 years, mass = 64.85±5.76 kg, height = 167.35±2.47 cm; n = 20', 'physically active females']","['multi-joint (MJ) training', 'Training specificity performing single-joint vs. multi-joint resistance exercises', 'Pre- and post-training, six repetitions maximum (RM) and maximal voluntary isometric contraction', 'single-joint (SJ) training', 'SJ', '8-week supervised single- or multi-joint lower limb training consisting of 18 sessions', 'training one multi-joint exercise (leg press) or two single-joint exercises (leg extension and kickback']","['6RM in leg extension and kickback', 'dynamic strength in leg press, kickback and leg extension', 'leg press 6RM', 'All strength and electromyographic measures', 'leg press and leg extension strength']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556502', 'cui_str': 'Lower limb training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086504', 'cui_str': 'Kickbacks'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086504', 'cui_str': 'Kickbacks'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",53.0,0.0304002,"The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002).","[{'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Stien', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Aril Hagen', 'Initials': 'AH', 'LastName': 'Ravnøy', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Saeterbakken', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}]",PloS one,['10.1371/journal.pone.0233540']
3008,32470022,Peripheral endothelial function can be improved by daily consumption of water containing over 7 ppm of dissolved hydrogen: A randomized controlled trial.,"BACKGROUND
Measurement of the reactive hyperemia index (RHI) using peripheral arterial tonometry (PAT) has shown benefits in the evaluation of vascular endothelial function and prediction of cardiovascular disease prognosis. Thus, it is important to examine the factors that promote the RHI. In this study, we aimed to investigate the effect of molecular hydrogen (H2) on reactive hyperemia-PAT of the small arteries of fingers in healthy people.
METHODS
To determine the efficacy of H2 for improving peripheral vascular endothelial function, water containing high H2 concentrations was administered to participants, and the Ln_RHI was measured in the finger vasculature. Sixty-eight volunteers were randomly divided into two groups: a placebo group (n = 34) that drank molecular nitrogen (N2)-containing water and a high H2 group (n = 34) that drank high H2 water (containing 7 ppm of H2: 3.5 mg H2 in 500-mL water). The Ln_RHI was measured before ingesting the placebo or high H2 water, 1 h and 24 h after the first ingestion, and 14 days after daily ingestion of high H2 water or the placebo. The mixed effects model for repeated measures was used in data analysis.
RESULTS
The high H2 group had a significantly greater improvement in Ln_RHI than the placebo group. Ln_RHI improved by 22.2% (p<0.05) at 24 h after the first ingestion of high H2 water and by 25.4% (p<0.05) after the daily consumption of high H2 water for 2 weeks.
CONCLUSIONS
Daily consumption of high H2 water improved the endothelial function of the arteries or arterioles assessed by the PAT test. The results suggest that the continuous consumption of high H2 water contributes to improved cardiovascular health.",2020,"Ln_RHI improved by 22.2% (p<0.05) at 24 h after the first ingestion of high H2 water and by 25.4% (p<0.05) after the daily consumption of high H2 water for 2 weeks.
","['Sixty-eight volunteers', 'healthy people']","['molecular hydrogen (H2', 'peripheral arterial tonometry (PAT', 'drank molecular nitrogen (N2)-containing water and a high H2 group (n = 34) that drank high H2 water (containing 7 ppm of H2: 3.5 mg H2 in 500-mL water', 'placebo']","['endothelial function', 'Ln_RHI', 'cardiovascular health', 'peripheral vascular endothelial function, water containing high H2 concentrations', 'Peripheral endothelial function']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",68.0,0.102059,"Ln_RHI improved by 22.2% (p<0.05) at 24 h after the first ingestion of high H2 water and by 25.4% (p<0.05) after the daily consumption of high H2 water for 2 weeks.
","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ishibashi', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kawamoto', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kasumi', 'Initials': 'K', 'LastName': 'Matsuno', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Genki', 'Initials': 'G', 'LastName': 'Ishihara', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Takamichi', 'Initials': 'T', 'LastName': 'Baba', 'Affiliation': 'Department of Rheumatology, Orthopaedic Surgery and Health Care, Huis Ten Bosch Satellite H2 Clinic Hakata, Hakata-ku, Fukuoka, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Komori', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0233484']
3009,32470089,A pilot randomized trial of incentive strategies to promote HIV retesting in rural Uganda.,"BACKGROUND
Retesting for HIV is critical to identifying newly-infected persons and reinforcing prevention efforts among at-risk adults. Incentives can increase one-time HIV testing, but their role in promoting retesting is unknown. We sought to test feasibility and acceptability of incentive strategies, including commitment contracts, to promote HIV retesting among at-risk adults in rural Uganda.
METHODS
At-risk HIV-negative adults were enrolled in a pilot trial assessing feasibility and acceptability of incentive strategies to promote HIV retesting three months after enrollment. Participants were randomized (1:1:3) to: 1) no incentive; 2) standard cash incentive (~US$4); and 3) commitment contract: participants could voluntarily make a low- or high-value deposit that would be returned with added interest (totaling ~US$4 including the deposit) upon retesting or lost if participants failed to retest. Contracts sought to promote retesting by leveraging loss aversion and addressing present bias via pre-commitment. Outcomes included acceptability of trial enrollment, contract feasibility (proportion of participants making deposits), and HIV retesting uptake.
RESULTS
Of 130 HIV-negative eligible adults, 123 (95%) enrolled and were randomized: 74 (60%) to commitment contracts, 25 (20%) to standard incentives, and 24 (20%) to no incentive. Of contract participants, 69 (93%) made deposits. Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups.
CONCLUSION
In a randomized trial of strategies to promote HIV retesting among at-risk adults in Uganda, incentive strategies, including commitment contracts, were feasible and had high acceptability. Our findings suggest use of incentives for HIV retesting merits further comparison in a larger trial.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT:02890459.",2020,"Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups.
","['risk adults in rural Uganda', 'At-risk HIV-negative adults', '130 HIV-negative eligible adults, 123 (95%) enrolled', 'HIV retesting in rural Uganda']",['1) no incentive; 2) standard cash incentive (~US$4); and 3) commitment contract: participants could voluntarily make a low- or high-value deposit that would be returned with added interest (totaling ~US$4 including the deposit'],"['acceptability of trial enrollment, contract feasibility (proportion of participants making deposits), and HIV retesting uptake', 'HIV: uptake']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",130.0,0.175444,"Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups.
","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ndyabakira', 'Affiliation': 'Infectious Diseases Research Collaboration, Mbarara, Uganda.'}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Marson', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Devy M', 'Initials': 'DM', 'LastName': 'Emperador', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Makerere University Joint AIDS Program, Kampala, Uganda.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0233600']
3010,32470230,Relationships Between Executive Function Improvement and ADHD Symptom Improvement With Lisdexamfetamine Dimesylate in Adults With ADHD and Executive Function Deficits: A Post Hoc Analysis.,"Objective
Executive function (EF) deficits are not generally considered synonymous with attention-deficit/hyperactivity disorder (ADHD). Evidence suggests stimulants improve ADHD symptoms and EF deficits in adults with ADHD, but the relationships between improvements in these domains have not been studied.
Methods
These post hoc analyses used data from a 10-week double-blind, placebo-controlled study of adults with ADHD and EF deficits treated with lisdexamfetamine dimesylate (30-70 mg) or placebo conducted from May 2010 to November 2010. Efficacy endpoints included change from baseline at week 10/early termination (ET) in self-report Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score and ADHD-Rating Scale with Adult Prompts total score (ADHD-RS-AP-TS). Relationships between ADHD symptom and EF changes were examined using recursive path analyses.
Results
Mediation proportions were 0.62 (indirect and total treatment effect coefficients [95% CI]: -6.85 [-9.83 to -3.86] and -11.12 [-14.88 to -7.37]) for self-report BRIEF-A GEC T-score change from baseline at week 10/ET on ADHD-RS-AP-TS change from baseline at week 10/ET and 0.93 (indirect and total treatment effect coefficients [95% CI]: -10.34 [-14.11 to -6.57] and -11.18 [-15.80 to -6.55]) for ADHD-RS-AP-TS change from baseline at week 10/ET on self-report BRIEF-A GEC T-score change from baseline at week 10/ET.
Conclusions
Although these data suggest ADHD symptom and EF deficit improvement following lisdexamfetamine are interdependent, it is advantageous to use measures like the BRIEF-A to assess stimulant effects on the wide range of EF deficits associated with ADHD that are not captured by the ADHD-RS-AP alone.
Trial Registration
Data used in this secondary analysis came from ClinicalTrials.gov identifier: NCT01101022.",2020,"Results
Mediation proportions were 0.62 (indirect and total treatment effect coefficients [95% CI]: -6.85","['adults with ADHD and EF deficits treated with', 'Adults With ADHD and Executive Function Deficits', 'adults with ADHD', 'conducted from May 2010 to November 2010']","['placebo', 'lisdexamfetamine', 'lisdexamfetamine dimesylate', 'Lisdexamfetamine Dimesylate']","['Objective\n\n\nExecutive function (EF) deficits', 'self-report BRIEF-A GEC T-score change', 'Global Executive Composite (GEC) T-score and ADHD-Rating Scale with Adult Prompts total score (ADHD-RS-AP-TS', 'ADHD symptoms and EF deficits', 'Executive Function Improvement and ADHD Symptom Improvement', 'change from baseline at week 10/early termination (ET) in self-report Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1873633', 'cui_str': 'Lisdexamfetamine'}, {'cui': 'C1739826', 'cui_str': 'Lisdexamfetamine dimesylate'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.127978,"Results
Mediation proportions were 0.62 (indirect and total treatment effect coefficients [95% CI]: -6.85","[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Brown', 'Affiliation': 'Brown Clinic for Attention & Related Disorders, 500 S Sepulveda Blvd, Ste 218, Manhattan Beach, CA 90266. tebrownyu@gmail.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Biostatistics, Shire, a member of the Takeda group of companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Global Clinical Development, Shire, a member of the Takeda group of companies, Lexington, Massachusetts; currently employed by Yumanity Therapeutics Inc, Cambridge, Massachusetts, USA.'}]",The primary care companion for CNS disorders,['10.4088/PCC.19m02559']
3011,32470239,"Effect of nanohydroxyapatite associated with photobiomodulation in the control of dentin hypersensitivity: A randomized, double-blind, placebo-controlled clinical trial.","PURPOSE
To evaluate the effect of nanohydroxyapatite ( nHAP) associated with photobiomodulation (PBM) in the control of dentin hypersensitivity (DH). (C-Shape It).
METHODS
32 subjects with 83 hypersensitive teeth were randomized into four groups (N =8) : GPlacebo - simulated PBM (without light emission) followed by the application of nHAP-free toothpaste; GLaser - PBM followed by the application of nHAP-free toothpaste; GnHAP - simulated PBM followed by the application of nHAP; GLasernHAP - PBM followed by the application of nHAP. A visual analogue scale (VAS) was used to measure DH after a tactile and evaporative stimulus. DH evaluations were performed at four times: baseline, 1st, and 2nd treatment sessions, and 1 month. A questionnaire was used to evaluate the risk factors associated with DH intensity. Mixed-design ANOVA followed by Tukey test and logistic regression were used.
RESULTS
The mechanical stimulus showed a significant reduction in DH in all experimental groups (P< 0.05) at the 2nd treatment session. For the evaporative stimulus, the GLasernHAP group presented a significant reduction in DH at the 1st treatment session (P< 0.05). Intragroup analysis showed that only the GnHAP group showed regression of DH at 1 month for the two applied stimuli. The variables of parafunctional habits, diets rich in acidic drinks and anxiety had significant relationships with the intensity of DH (P< 0.05).
CLINICAL SIGNIFICANCE
The use of nHAP and application of PBM to laser are effective in the control of dentin hypersensitivity. However, their association did not enhance the desensitizing effect.",2020,Intragroup analysis showed that only the GnHAP group showed regression of DH at 1 month for the two applied stimuli.,"['32 subjects with 83 hypersensitive teeth', 'dentin hypersensitivity', 'dentin hypersensitivity (DH']","['nanohydroxyapatite', 'GnHAP', 'GLasernHAP', 'photobiomodulation (PBM', 'photobiomodulation', 'GPlacebo - simulated PBM (without light emission) followed by the application of nHAP-free toothpaste; GLaser - PBM followed by the application of nHAP-free toothpaste; GnHAP - simulated PBM followed by the application of nHAP; GLasernHAP - PBM', 'nanohydroxyapatite ( nHAP', 'placebo']","['DH', 'visual analogue scale (VAS']","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0645108', 'cui_str': 'N-hydroxy-2-aminopyrene'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",32.0,0.0213293,Intragroup analysis showed that only the GnHAP group showed regression of DH at 1 month for the two applied stimuli.,"[{'ForeName': 'Cristiane deM', 'Initials': 'CD', 'LastName': 'Alencar', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazilcstewa32@uthsc.edu.'}, {'ForeName': 'Mariangela Ig', 'Initials': 'MI', 'LastName': 'Ortiz', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Silva', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil.'}, {'ForeName': 'Eliane B', 'Initials': 'EB', 'LastName': 'Alves', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil.'}, {'ForeName': 'Jesuína Ln', 'Initials': 'JL', 'LastName': 'Araújo', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil.'}, {'ForeName': 'Cecy M', 'Initials': 'CM', 'LastName': 'Silva', 'Affiliation': 'School of Dentistry, Federal University of Para, Belem, PA, Brazil, cecymsilva@gmail.com.'}]",American journal of dentistry,[]
3012,32470240,Marginal adaptation and internal indentation resistance of a Class II bulk-fill resin-based composite.,"PURPOSE
To compare the dentin bonded external marginal integrity and the internal surface indentation hardness of bulk-fill and conventional resin-based composite (RBC) placed in both bulk and increments.
METHODS
120 MO and DO cavities were prepared in 60 extracted human third molars. The teeth were randomly divided into four groups of 15 teeth per group to be restored as follows: BB (bulk-fill RBC, placed in a 4 mm bulk increment), BL (bulk-fill RBC, placed in 2 mm incremental layers), CB (conventional RBC, placed in a 4 mm bulk increment), and CL (conventional RBC, placed in 2 mm incremental layers). Marginal gaps were measured at mesial and distal dentin gingival cavosurfaces of each tooth using scanning electron microscopy of epoxy resin replicas and Knoop hardness (KHN) was measured at three different RBC depths (1.8, 2.8 and 3.8 mm). Statistical analyses included one-way ANOVA with post-hoc Tukey's HSD, and paired-sample t-test or a nonparametric Wilcoxon signed-rank test, as appropriate.
RESULTS
There was no significant effect of RBC restoration type on external marginal gap at the distal surface or at the mesial surface among the four groups tested (P> 0.05 in each instance), while no significant difference in external marginal gap was found between the mesial and distal surfaces within groups (P> 0.05 in each instance). The mean RBC internal surface KHN at 1.8 mm depth was significantly greater than at 2.8 mm and 3.8 mm depths in all tested groups (P< 0.05 for all instances), with a similar mean internal hardness between all groups. The bulk-fill RBC restorations demonstrated similar marginal gap formation and Knoop hardness to conventional universal RBC restorations under the conditions of this study.
CLINICAL SIGNIFICANCE
Bulk-fill resin-based composite (RBC), from the perspective of marginal adaptation and internal hardness, may be a suitable alternative to conventional RBC.",2020,"There was no significant effect of RBC restoration type on external marginal gap at the distal surface or at the mesial surface among the four groups tested (P> 0.05 in each instance), while no significant difference in external marginal gap was found between the mesial and distal surfaces within groups (P> 0.05 in each instance).",['120 MO and DO cavities were prepared in 60 extracted human third molars'],[],"['Marginal adaptation and internal indentation resistance', 'RBC restoration type on external marginal gap at the distal surface', 'mean RBC internal surface KHN', 'external marginal gap']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]",[],"[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332467', 'cui_str': 'Indentation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",,0.0209519,"There was no significant effect of RBC restoration type on external marginal gap at the distal surface or at the mesial surface among the four groups tested (P> 0.05 in each instance), while no significant difference in external marginal gap was found between the mesial and distal surfaces within groups (P> 0.05 in each instance).","[{'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'El Naga', 'Affiliation': 'Orthodontics Program, Georgia School of Orthodontics, Atlanta, Georgia, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qian', 'Affiliation': 'Division of Biostatistics and Computational Biology and Adjunct Faculty, Department of Preventive and Community Dentistry, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Gerald E', 'Initials': 'GE', 'LastName': 'Denehy', 'Affiliation': 'Department of Operative Dentistry, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Quock', 'Affiliation': 'Department of Restorative Dentistry & Prosthodontics, University of Texas School of Dentistry at Houston, Houston, Texas, USA, Ryan.Quock@uth.tmc.edu.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Armstrong', 'Affiliation': 'Department of Operative Dentistry, The University of Iowa, Iowa City, Iowa, USA.'}]",American journal of dentistry,[]
3013,32470241,"Safety and efficacy of a novel toothbrush utilizing RF energy for the reduction of plaque, calculus and gingivitis.","PURPOSE
To evaluate the safety and efficacy of the ToothWave radiofrequency (RF) toothbrush in the reduction of plaque, calculus and gingival inflammation, as compared to a standard powered toothbrush accepted by the American Dental Association (ADA).
METHODS
This was a single-blind, double arm, prospective study. Subjects were randomized to one of two treatment groups, receiving either the RF powered toothbrush or a control powered toothbrush, and performing twice daily brushing for a test period of 6 weeks. Plaque (RMNPI), calculus (V-MI), gingival inflammation (MGI) and bleeding (GBI) were assessed at baseline, after 4 and 6 weeks. Comparisons were completed both within and between each treatment group. Statistical analyses were conducted using the Mann Whitney non-parametric model.
RESULTS
85 subjects completed the study and had fully evaluable data. No significant differences between the groups were found in the baseline scores (P≥ 0.165). Following 6 weeks, the RF test group demonstrated statistically significant reductions in plaque, gingivitis and calculus compared to the control powered toothbrush (P≤ 0.001). Both toothbrushes were well-tolerated and no device-related adverse events were reported. The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush.
CLINICAL SIGNIFICANCE
The RF powered toothbrush used twice daily resulted in an overall improvement in oral health.",2020,"The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush.
",['85 subjects completed the study and had fully evaluable data'],"['RF powered toothbrush or a control powered toothbrush', 'novel toothbrush utilizing RF energy', 'ToothWave radiofrequency (RF) toothbrush']","['plaque, calculus and gingival inflammation', 'oral health', 'Plaque (RMNPI), calculus (V-MI), gingival inflammation (MGI) and bleeding (GBI', 'plaque, gingivitis and calculus', 'safety and efficacy', 'Safety and efficacy', 'tolerated and no device-related adverse events', 'dental plaque, calculus deposition, gingival inflammation and gingival bleeding', 'plaque, calculus and gingivitis']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}]",85.0,0.0424656,"The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush.
","[{'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Fort Wayne, IN, USA.'}, {'ForeName': 'Liora', 'Initials': 'L', 'LastName': 'Levi', 'Affiliation': 'Home Skinovations, Ltd., Yokneam, Israel, lioral@silkn.com.'}, {'ForeName': 'Tori L', 'Initials': 'TL', 'LastName': 'Grahovac', 'Affiliation': 'Salus Research, Fort Wayne, IN, USA.'}, {'ForeName': 'Jeffery L', 'Initials': 'JL', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Fort Wayne, IN, USA.'}]",American journal of dentistry,[]
3014,32470242,Influence of mechanical and chemical degradation on surface gloss of direct and CAD-CAM resin composite materials.,"PURPOSE
To compare the gloss retention of four resin based materials, two direct resin composites (Tetric EvoCeram and Filtek Supreme) and two indirect resin composite CAD-CAM blocks (Tetric CAD and Lava Ultimate).
METHODS
36 samples of 1 mm thickness were readied of each test material and manually polished with polishing discs (Sof-Lex) up to the finest grit size. Three gloss measurements per sample were taken (one every 120 degrees of sample rotation) by means of a glossmeter (Novo-Curve) for a total of 60 values obtained per tested material. Samples of each material were then randomly divided into three equal groups and aged with 75% alcohol (Group 1), amine fluoride gel (Elmex gelée) (Group 2) or mechanical brushing (Group 3). Another set of gloss measurements was performed on all samples after 1 hour of aging. Gloss values were statistically evaluated by means of repeated measures ANOVA and Fisher's LSD post-hoc tests.
RESULTS
Gloss retention values ranged from 59.0 (Tetric EvoCeram) to 70.9 (Lava Ultimate) for alcohol, from 59.3 (Filtek Supreme) to 67.5 (Lava Ultimate) for Elmex gelèe and from 33.3 (Tetric EvoCeram) to 53.4 (Lava Ultimate) for mechanical brushing. Statistical analysis revealed: (1) significant difference between intial and final gloss values for all materials and groups; (2) significant difference between final gloss values of all the materials in the alcohol group; (3) significant difference between final gloss values of Lava Ultimate and all the other materials in the Elmex gelèe group; (4) significant difference between final gloss values of Lava Ultimate and Tetric CAD with the other tested materials in the brushing group.
CLINICAL SIGNIFICANCE
Direct resin composites in general are widely used, and CAD-CAM resin composite materials are becoming progressively more accessible. Making the choice between direct and indirect techniques is still a challenge, and understanding the advantages of CAD-CAM resin composites in the form of higher gloss retention, which translates into higher durability of esthetics, may be one the parameters facilitating the decision.",2020,"RESULTS
Gloss retention values ranged from 59.0 (Tetric EvoCeram) to 70.9 (Lava Ultimate) for alcohol, from 59.3 (Filtek Supreme) to 67.5 (Lava Ultimate) for Elmex gelèe and from 33.3 (Tetric EvoCeram) to 53.4 (Lava Ultimate) for mechanical brushing.",['36 samples of 1 mm thickness were readied of each test material and manually polished with polishing discs (Sof-Lex) up to the finest grit size'],"['mechanical brushing', 'amine fluoride gel (Elmex gelée']","['Lava Ultimate', 'Lava Ultimate and Tetric CAD']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0080188', 'cui_str': 'Lymphocyte antigen CD15'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0440273', 'cui_str': 'Grit'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0169339', 'cui_str': 'amine fluoride gel'}, {'cui': 'C0059034', 'cui_str': 'Elmex'}]","[{'cui': 'C0292041', 'cui_str': 'Tetric'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]",,0.0173536,"RESULTS
Gloss retention values ranged from 59.0 (Tetric EvoCeram) to 70.9 (Lava Ultimate) for alcohol, from 59.3 (Filtek Supreme) to 67.5 (Lava Ultimate) for Elmex gelèe and from 33.3 (Tetric EvoCeram) to 53.4 (Lava Ultimate) for mechanical brushing.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ardu', 'Affiliation': 'Division of Cariology & Endodontology, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland, stefano.ardu@unige.ch.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Daher', 'Affiliation': 'Division of Cariology & Endodontology, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Bella', 'Affiliation': 'Department of Economics and Quantitative Methods, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Isaline', 'Initials': 'I', 'LastName': 'Rossier', 'Affiliation': 'Division of Cariology & Endodontology, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Krejci', 'Affiliation': 'Division of Cariology & Endodontology, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland.'}]",American journal of dentistry,[]
3015,32470244,Prospective randomized clinical trial of primary molar crowns: 36-month results.,"PURPOSE
To clinically evaluate the clinical success of a primary zirconia molar crown, compared with stainless steel crowns (SSCs).
METHODS
This randomized, controlled clinical trial was designed as a split-mouth study. 50 subjects ranging in age from 3-7 years were recruited to provide a total of 50 paired teeth requiring primary molar crowns, each participant receiving a SSC and zirconia crown. Restorations were evaluated at 6-, 12-, 24-, and 36-month recall appointments examining the following criteria: gingival health, estimate of the degree crown was high in occlusion, surface roughness, staining on crown surface, wear of opposing arch tooth, color match, anatomic form, marginal integrity, marginal discoloration, proximal contact area, secondary caries at crown margin and parent/guardian satisfaction with crown appearance.
RESULTS
The 36-month follow up included 23 subjects (46%). 35 crowns (35%) were evaluated; of the 18 zirconia crowns and 17 SSCs, there were no failures at the 36-month evaluation. The only significant differences in the parameters evaluated were parent satisfaction, with the zirconia crown preference (P< 0.05) and gingival health, with the zirconia crowns having healthy adjacent gingiva (P< 0.01). The 36-month results indicated that zirconia primary molar crowns performed similarly to an established SSC for restoration of primary molars.
CLINICAL SIGNIFICANCE
The findings from this study indicated that at 36 months, NuSmile ZR zirconia crowns clinically performed as well as stainless steel crowns.",2020,"The only significant differences in the parameters evaluated were parent satisfaction, with the zirconia crown preference (P< 0.05) and gingival health, with the zirconia crowns having healthy adjacent gingiva (P< 0.01).","['primary molar crowns', '50 subjects ranging in age from 3-7 years were recruited to provide a total of 50 paired teeth requiring primary molar crowns, each participant receiving a SSC and zirconia crown']",['stainless steel crowns (SSCs'],"['gingival health', 'occlusion, surface roughness, staining on crown surface, wear of opposing arch tooth, color match, anatomic form, marginal integrity, marginal discoloration, proximal contact area, secondary caries at crown margin and parent/guardian satisfaction with crown appearance', 'zirconia crown preference']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}]","[{'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",50.0,0.0488815,"The only significant differences in the parameters evaluated were parent satisfaction, with the zirconia crown preference (P< 0.05) and gingival health, with the zirconia crowns having healthy adjacent gingiva (P< 0.01).","[{'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Donly', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA, donly@uthscsa.edu.'}, {'ForeName': 'Maria José C', 'Initials': 'MJC', 'LastName': 'Méndez', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Claudia I', 'Initials': 'CI', 'LastName': 'Contreras', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Jungyi A', 'Initials': 'JA', 'LastName': 'Liu', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}]",American journal of dentistry,[]
3016,32450367,Measures of adherence as predictors of early and total weight loss with intensive behavioral therapy for obesity combined with liraglutide 3.0 mg.,"Individual weight loss outcomes with intensive behavioral therapy (IBT) for obesity are variable. The present study assessed whether visit attendance, dietary self-monitoring, medication, and meal-replacement adherence were associated with 52-week weight loss with IBT and tested whether these relationships were independent of associations with early weight loss. This was a secondary analysis of a randomized trial in which 150 participants (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m 2 ) received either IBT alone, IBT with liraglutide 3.0 mg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%. Only self-monitoring was independently associated with weight loss. In the 100 liraglutide-treated participants, medication adherence accounted for an additional 9.9% of the variance in 52-week weight loss, and both self-monitoring and medication adherence were independent correlates. For the 50 Multi-component participants, meal replacement adherence did not predict weight loss. Early weight loss was associated with higher early and subsequent session attendance and dietary self-monitoring. However, self-monitoring and medication adherence remained important correlates of total weight loss when controlling for this variable. Strategies that help improve self-monitoring consistency and medication usage could improve weight loss with IBT.",2020,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","['150 participants (76.1% female, 55.8% white, BMI\u202f=\u202f38.8\u202f±\u202f4.8\u202fkg/m 2 ']","['intensive behavioral therapy (IBT', 'IBT alone, IBT with liraglutide 3.0\u202fmg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'liraglutide']","['Early weight loss', 'weight loss', 'total weight loss', 'visit attendance, dietary self-monitoring, medication, and meal-replacement adherence', 'self-monitoring and medication adherence', 'medication adherence']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517765', 'cui_str': '4.8'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",150.0,0.0213041,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","[{'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA. Electronic address: jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': ""Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Department of Child and Adolescent Psychiatry, Philadelphia, PA, USA.""}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; University of Pennsylvania School of Nursing, Department of Biobehavioral Health Sciences, Philadelphia, PA, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103639']
3017,32450497,Effect of brexpiprazole on control of impulsivity in schizophrenia: A randomized functional magnetic resonance imaging study.,"Impulsivity in schizophrenia is a risk factor for suicide, drug abuse, and other risk-taking behaviors. This exploratory, multicenter, randomized, double-blind, functional magnetic resonance imaging (fMRI) study assessed the effects of brexpiprazole on brain regions that control impulsive behavior. Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms were randomized to 6 weeks of brexpiprazole 2 or 4 mg/day. The prespecified outcome measure was blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task. Secondary objectives evaluated the efficacy, safety and tolerability of brexpiprazole. Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task. Brexpiprazole was also associated with significantly improved stop-signal reaction time (SSRT). No worsening of psychiatric symptoms, functioning, or impulsivity occurred in these patients. No unexpected safety or tolerability concerns were identified. In conclusion, brexpiprazole treatment among patients with schizophrenia and impulsivity was associated with decreased right VLPFC activation and decreased SSRT, supportive of a benefit of brexpiprazole on inhibition-related brain activation and behavior. ClinicalTrials.gov identifier: NCT02194933.",2020,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","['Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms', 'schizophrenia', 'patients with schizophrenia and impulsivity']","['brexpiprazole', 'functional magnetic resonance imaging (fMRI', 'Brexpiprazole']","['blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task', 'right VLPFC BOLD activation', 'safety or tolerability concerns', 'right VLPFC activation', 'psychiatric symptoms, functioning, or impulsivity', 'efficacy, safety and tolerability of brexpiprazole', 'stop-signal reaction time (SSRT']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",38.0,0.07473,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","[{'ForeName': 'Theo Gm', 'Initials': 'TG', 'LastName': 'van Erp', 'Affiliation': 'Clinical and Translational Neuroscience Laboratory, University of California-Irvine, Irvine, CA, United States; Center for the Neurobiology of Learning and Memory, University of California-Irvine, Irvine, CA, United States. Electronic address: tvanerp@uci.edu.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Baker', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Okame', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eramo', 'Affiliation': 'Lundbeck LLC, Deerfield, IL, United States.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Potkin', 'Affiliation': 'University of California-Irvine, Irvine, CA, United States; Tibor Rubin Veterans Affairs Medical Center, Long Beach, CA, United States. Electronic address: sgpotkin@gmail.com.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111085']
3018,32450831,Emerging pesticides responsible for suicide in rural Sri Lanka following the 2008-2014 pesticide bans.,"BACKGROUND
Sri Lanka has reduced its overall suicide rate by 70% over the last two decades through means restriction, through a series of government regulations and bans removing highly hazardous pesticides from agriculture. We aimed to identify the key pesticide(s) now responsible for suicides in rural Sri Lanka to provide data for further pesticide regulation.
METHODS
We performed a secondary analysis of data collected prospectively during a cluster randomized controlled trial in the Anuradhapura district of Sri Lanka from 2011 to 16. The identity of pesticides responsible for suicides were sought from medical or judicial medical notes, coroners' records, and the person's family. Trend analysis was done using a regression analysis with curve estimation to identify relative importance of key pesticides.
RESULTS
We identified 337 suicidal deaths. Among them, the majority 193 (57.3%) were due to ingestion of pesticides while 82 (24.3%) were due to hanging. A specific pesticide was identified in 105 (54.4%) of the pesticide suicides. Ingestion of carbosulfan or profenofos was responsible for 59 (56.2%) of the suicides with a known pesticide and 17.5% of all suicides. The increasing trend of suicides due to carbosulfan and profenofos over time was statistically significant (R square 0.846, F 16.541, p 0.027).
CONCLUSION
Ingestion of pesticides remains the most important means of suicides in rural Sri Lanka. The pesticides that were once responsible for most pesticide suicides have now been replaced by carbosulfan and profenofos. Their regulation and replacement in agriculture with less hazardous pesticides will further reduce the incidence of both pesticide and overall suicides in rural Sri Lanka.",2020,Ingestion of carbosulfan or profenofos was responsible for 59 (56.2%) of the suicides with a known pesticide and 17.5% of all suicides.,"['rural Sri Lanka following the 2008-2014 pesticide bans', '337 suicidal deaths', 'Anuradhapura district of Sri Lanka from 2011 to 16']",[],['overall suicide rate'],"[{'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031253', 'cui_str': 'Pesticide'}, {'cui': 'C0105185', 'cui_str': 'BANS'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",,0.0803916,Ingestion of carbosulfan or profenofos was responsible for 59 (56.2%) of the suicides with a known pesticide and 17.5% of all suicides.,"[{'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Weerasinghe', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka, Anuradhapura, Sri Lanka.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pearson', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Konradsen', 'Affiliation': 'Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Suneth', 'Initials': 'S', 'LastName': 'Agampodi', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka, Anuradhapura, Sri Lanka.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Sumith', 'Affiliation': 'Office of the Registrar of Pesticides, Getambe, Peradeniya, Sri Lanka.'}, {'ForeName': 'Shaluka', 'Initials': 'S', 'LastName': 'Jayamanne', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'S M H M K', 'Initials': 'SMHMK', 'LastName': 'Senanayake', 'Affiliation': 'Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka.'}, {'ForeName': 'Sandamali', 'Initials': 'S', 'LastName': 'Rajapaksha', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eddleston', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka. m.eddleston@ed.ac.uk.'}]",BMC public health,['10.1186/s12889-020-08871-7']
3019,32450857,Harnessing health plan enrollee data to boost membership in patient-powered research networks.,"BACKGROUND
Patient-powered research networks (PPRNs) have been employing and exploring different methods to engage patients in research activities specific to their conditions. One way to intensify patient engagement is to partner with payer stakeholders. The objective of this study was to evaluate the effectiveness of two common payer-initiated outreach methods (postal mail versus email) for inviting prospective candidates to participate in their initiatives.
METHODS
This descriptive study linked members of a nationally-representative private insurance network to four disease-specific PPRN registries. Eligible members meeting diagnostic criteria who were not registered in any of the four PPRNs by 02/28/2018 were identified, and randomly assigned to either the mail or email group. They were contacted in two outreach efforts: first on 04/23/2018, and one follow-up on 05/23/2018. New registration rates by outreach method as of 8/31/2018 were determined by relinking. We compared registrants and non-registrants using bivariate analysis.
RESULTS
A total of 14,571 patients were assigned to the mail group, and 14,574 to the email group. Invitations were successfully delivered to 13,834 (94.9%) mail group and 10,205 (70.0%) email group members. A small but significantly larger proportion of mail group members, (n = 78; 0.54, 95% Confidence Interval [CI] {0.42-0.67%}) registered in PPRNs relative to the email group (n = 24; 0.16, 95% CI {0.11-0.25%}), p < 0.001. Members who registered had more comorbidities, were more likely to be female, and had marginally greater medical utilization, especially emergency room visits, relative to non-registrants (52.0% vs. 42.5%, p = 0.05).
CONCLUSION
A health plan outreach to invite members to participate in PPRNs was modestly effective. Regular mail outperformed less costly email. Providing more value-add to participants may be a possible way to increase recruitment success.",2020,"A small but significantly larger proportion of mail group members, (n = 78; 0.54, 95% Confidence Interval [CI] {0.42-0.67%}) registered in PPRNs relative to the email group (n = 24; 0.16, 95% CI {0.11-0.25%}), p < 0.001.","['members of a nationally-representative private insurance network to four disease-specific PPRN registries', '14,571 patients were assigned to the mail group, and 14,574 to the email group', 'Eligible members meeting diagnostic criteria who were not registered in any of the four PPRNs by 02/28/2018']",['two common payer-initiated outreach methods (postal mail versus email'],['medical utilization'],"[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0013849', 'cui_str': 'Email'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",14571.0,0.0395978,"A small but significantly larger proportion of mail group members, (n = 78; 0.54, 95% Confidence Interval [CI] {0.42-0.67%}) registered in PPRNs relative to the email group (n = 24; 0.16, 95% CI {0.11-0.25%}), p < 0.001.","[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'HealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE, 19801-5134, USA. xchen@healthcore.com.'}, {'ForeName': 'Abiy', 'Initials': 'A', 'LastName': 'Agiro', 'Affiliation': 'HealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE, 19801-5134, USA.'}, {'ForeName': 'W Benjamin', 'Initials': 'WB', 'LastName': 'Nowell', 'Affiliation': 'Global Healthy Living Foundation, Upper Nyack, New York, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Loud', 'Affiliation': 'Accelerated Cure Project, Waltham, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McBurney', 'Affiliation': 'Accelerated Cure Project, Waltham, MA, USA.'}, {'ForeName': 'Kalen', 'Initials': 'K', 'LastName': 'Young', 'Affiliation': 'Vasculitis Foundation, Kansas City, MO, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sutphen', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bourquardez Clark', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Burroughs', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Sreih', 'Affiliation': 'Division of Rheumatology and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'Division of Rheumatology and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'HealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE, 19801-5134, USA.'}]",BMC health services research,['10.1186/s12913-020-05325-z']
3020,32450869,Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies.,"BACKGROUND
The Phase III PINNACLE studies assessed the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), a dual long-acting bronchodilator for chronic obstructive pulmonary disease (COPD). Here we present a pre-specified pooled analysis of PINNACLE-1, PINNACLE-2, and PINNACLE-4.
METHODS
PINNACLE-1, -2, and -4 were multicenter, double-blind, randomized controlled trials that enrolled patients with moderate-to-very severe COPD, with no requirement for exacerbation history or a high symptom burden. Patients received GFF MDI 18/9.6 μg, glycopyrrolate (GP) MDI 18 μg, formoterol fumarate (FF) MDI 9.6 μg, or placebo MDI, twice-daily for 24 weeks. The primary endpoint of the pooled analysis was the change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV 1 ) at week 24. Secondary endpoints included COPD exacerbations and clinically important deterioration (CID). Adverse events were also assessed.
RESULTS
The pooled intent-to-treat population included 4983 patients; of these, 61.9% had a COPD assessment test (CAT) score ≥15, and 25.0% had experienced ≥1 moderate/severe exacerbation in the past year. At week 24, GFF MDI improved morning pre-dose trough FEV 1 versus GP MDI (least squares mean [LSM] difference [95% confidence interval (CI)]: 59 mL [43, 75]), FF MDI (65 mL [48, 81]), and placebo MDI (146 mL [125, 166]); all p < 0.0001. GFF MDI reduced the risk of a moderate/severe exacerbation by 18% (p = 0.0168), 15% (p = 0.0628), and 28% (p = 0.0012) compared with GP MDI, FF MDI, and placebo MDI, respectively. In general, exacerbation risk reduction with GFF MDI versus comparators was greater in subgroups of symptomatic patients (CAT ≥15) and those who had an exacerbation history, than in the pooled intent-to-treat population. The risk of CID was also lower with GFF MDI versus GP MDI (23% decrease), FF MDI (17%), and placebo MDI (49%); all p < 0.0001. All treatments were well tolerated, with no unexpected safety signals.
CONCLUSIONS
This pooled analysis of the PINNACLE studies demonstrated that GFF MDI improved lung function and reduced the risk of exacerbations compared with monocomponents and placebo in patients with COPD. Exacerbation reductions with GFF MDI versus comparators were generally greater in patients with higher symptom burden and those with exacerbation history.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01854645, NCT01854658, and NCT02343458. Registered 13 May 2013 (NCT01854645, NCT01854658) and 6 January 2015 (NCT02343458).",2020,"GFF MDI reduced the risk of a moderate/severe exacerbation by 18% (p = 0.0168), 15% (p = 0.0628), and 28% (p = 0.0012) compared with GP MDI, FF MDI, and placebo MDI, respectively.","['4983 patients; of these, 61.9% had a COPD assessment test (CAT) score ≥15, and 25.0% had experienced ≥1 moderate/severe exacerbation in the past year', 'patients with COPD', 'patients with moderate-to-very severe COPD', 'enrolled patients with moderate-to-very severe COPD, with no requirement for exacerbation history or a high symptom burden', 'chronic obstructive pulmonary disease (COPD']","['placebo MDI', 'GFF MDI 18/9.6\u2009μg, glycopyrrolate (GP) MDI 18\u2009μg, formoterol fumarate (FF) MDI 9.6\u2009μg, or placebo MDI', 'GFF MDI', 'glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI', 'placebo']","['lung function and reducing exacerbations', 'COPD exacerbations and clinically important deterioration (CID', 'risk of exacerbations', 'Adverse events', 'risk of a moderate/severe exacerbation', 'FF MDI', 'lung function', 'efficacy and safety', 'GFF MDI improved morning pre-dose trough FEV 1 versus GP MDI', 'morning pre-dose trough forced expiratory volume', 'risk of CID']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",4983.0,0.642539,"GFF MDI reduced the risk of a moderate/severe exacerbation by 18% (p = 0.0168), 15% (p = 0.0628), and 28% (p = 0.0012) compared with GP MDI, FF MDI, and placebo MDI, respectively.","[{'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medical College, New York-Presbyterian Hospital/Weill Cornell Medical Center, 525 E 68th St, Room M-522, Box 130, New York, NY, 10065, USA. fjm2003@med.cornell.edu.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Lipworth', 'Affiliation': 'Scottish Centre for Respiratory Research, Ninewells Hospital, University of Dundee, Dundee, Scotland, UK.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Kiel, Germany.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Collier', 'Affiliation': 'William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'University at Buffalo, SUNY, Buffalo, NY, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Feldman', 'Affiliation': 'S. Carolina Pharmaceutical Research, Spartanburg, SC, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': ""O'Brien"", 'Affiliation': 'formerly of AstraZeneca, Wilmington, DE, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}]",Respiratory research,['10.1186/s12931-020-01388-y']
3021,32450875,Transfer of skills for difficult intubation after videolaryngoscopy training: a randomized simulation study.,,2020,,[],['videolaryngoscopy training'],[],[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0560831,,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Kee', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, National University Hospital, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore, 119228, Singapore. Adrian_cl_kee@nuhs.edu.sg.'}, {'ForeName': 'Reyor', 'Initials': 'R', 'LastName': 'Ko', 'Affiliation': 'Ministry of Health Holdings, Singapore, Singapore.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Capistrano', 'Affiliation': 'Division of Critical Care -- Respiratory Therapy, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Dajac', 'Affiliation': 'Division of Critical Care -- Respiratory Therapy, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Juvel', 'Initials': 'J', 'LastName': 'Taculod', 'Affiliation': 'Division of Critical Care -- Respiratory Therapy, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Kay Choong', 'Initials': 'KC', 'LastName': 'See', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, National University Hospital, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore, 119228, Singapore.'}]","Critical care (London, England)",['10.1186/s13054-020-02982-8']
3022,32450901,Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial.,"BACKGROUND
The evidence-based guideline entitled guideline evidence-based health information emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. The guideline addresses providers of health information and its goal is to improve the quality of health information. In addition, we explored the competences of providers of health information and developed a training programme. The aim of this study is to evaluate the efficacy of a training programme addressing providers of health information to support the application of the guideline evidence-based health information. We expected the intervention to improve the quality of health information in comparison to the provision of the guideline on its own.
METHODS/DESIGN
The trial uses a superiority randomised control group design with 10 months' follow-up. Twenty-six providers of health information (groups with up to ten members) will be enrolled to compare the intervention (guideline and training programme) with usual care (a publicly available guideline). The 5-day training programme comprises an evidence-based medicine training module and a module to prepare the application of the guideline. The primary outcome parameter is the quality of the health information. Quality is operationalised as the extent of adherence to the guideline's recommendations. Each provider will prepare a single health information item informing a health-related decision on a topic freely chosen before randomisation. The quality of this information will be rated using the Mapping Health Information Quality (MAPPinfo) Checklist. An accompanying process evaluation will then be conducted.
DISCUSSION
The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term.
TRIAL REGISTRATION
ISRCTN registry, ID: ISRCTN96941060. Registered on 7 March 2019.",2020,"The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term.
",['Twenty-six providers of health information (groups with up to ten members'],"['training programme', 'intervention (guideline and training programme) with usual care (a publicly available guideline']",['quality of the health information'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0719784,"The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lühnen', 'Affiliation': 'Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany. Julia.Luehnen@medizin.uni-halle.de.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Berger-Höger', 'Affiliation': 'Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Haastert', 'Affiliation': 'mediStatistica, Lambertusweg 1b, 58809, Neuenrade, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hinneburg', 'Affiliation': 'Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kasper', 'Affiliation': 'Faculty of Health Sciences, Department of Health and Caring Sciences, University of Tromsø, Postbox 6050, Langnes, Norway.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Steckelberg', 'Affiliation': 'Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany.'}]",Trials,['10.1186/s13063-020-04287-1']
3023,32450921,Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis.,"BACKGROUND
Radiotherapy of head-and-neck cancer can be associated with significant toxicities including dermatitis and oral mucositis. Severe toxicities may require interruptions of the radiation treatment associated with impairment of the patients' prognoses. This study will investigate whether the addition of a reminder app to standard care can reduce dermatitis and oral mucositis rates during radiotherapy in these patients.
METHODS
This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥ 2 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head- and-neck cancer. Moreover, radiation-induced dermatitis and oral mucositis grade ≥ 3 at 60 Gy and both grade ≥ 2 and grade ≥ 3 at the end of radiation treatment (EOT) will be evaluated, as well as quality of life and pain. According to sample size calculations, 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. The impact of the reminder app will be considered clinically relevant, if the rates of grade ≥ 2 radiation dermatitis (primary endpoint) and oral mucositis (secondary endpoint) can be reduced by 20%.
DISCUSSION
If the addition of a reminder app to standard care will lead to a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for patients with head-and-neck cancer during radiotherapy.
TRIAL REGISTRATION
clinicaltrials.gov (NCT04110977). Registered on September 27, 2019. First patient is planned to be included in December 2019.",2020,"This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥ 2 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head- and-neck cancer.","['head-and-neck cancer', 'patients with head-and-neck cancer during radiotherapy', 'for locally advanced head- and-neck cancer', 'and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis']","['standard care alone (Arm B) with respect to grade\u2009≥\u20092 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy', 'mobile application reminding head', 'radiotherapy', 'Radiotherapy']","['quality of life and pain', 'Severe toxicities', 'radiation dermatitis and oral mucositis', 'skin toxicity', 'dermatitis and oral mucositis rates']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0746787', 'cui_str': 'Malignant tumor of neck'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0557033', 'cui_str': 'Reminding'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}]",,0.117227,"This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥ 2 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head- and-neck cancer.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Rades', 'Affiliation': 'Department of Radiation Oncology, University of Lübeck, Lübeck, Germany. rades.dirk@gmx.net.'}, {'ForeName': 'Carlos Andres', 'Initials': 'CA', 'LastName': 'Narvaez', 'Affiliation': 'Department of Radiation Oncology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Doemer', 'Affiliation': 'Department of Radiation Oncology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssen', 'Affiliation': 'Medical Practice for Radiotherapy and Radiation Oncology, Hanover, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Olbrich', 'Affiliation': 'Centre for Clinical Trials Lübeck, Lübeck, Germany.'}, {'ForeName': 'Soeren', 'Initials': 'S', 'LastName': 'Tvilsted', 'Affiliation': 'Research Projects and Clinical Optimization, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Conde-Moreno', 'Affiliation': 'Department of Radiation Oncology, Hospital Universitario y Politecnico La Fe, Valencia, Spain.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Cacicedo', 'Affiliation': 'Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute, Barakaldo, Vizcaya, Spain.'}]",Trials,['10.1186/s13063-020-04307-0']
3024,32452336,Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal.,"AIMS
Psychological interventions that are brief, acceptable, effective and can be delivered by non-specialists are especially necessary in low- and middle-income countries, where mental health systems are unable to address the high level of psychosocial needs. Problem Management Plus (PM+) is a five-session intervention designed for those impaired by psychological distress while living in communities affected by adversity. Individual PM+ has demonstrated effectiveness in reducing distress in Kenya and Pakistan, and a group version of PM+ (Group PM+) was effective for conflict-affected women in Pakistan. This paper describes a feasibility and acceptability trial of locally adapted Group PM+ for women and men in an earthquake-affected region of rural Nepal.
METHODS
In this feasibility cluster randomised controlled trial, participants in the experimental arm were offered five sessions of Group PM+ and participants in the control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG). A mixed-methods design was used to assess the feasibility and acceptability of Group PM+. Feasibility was assessed with criteria including fidelity and retention of participants. Acceptability was assessed through in-depth interviews with participants, family members, programme staff and other stakeholders. The primary clinical outcome was depression symptoms assessed using the Patient Health Questionnaire (PHQ-9) administered at baseline and 8-8.5 weeks post-baseline (i.e. after completion of Group PM+ or EUC).
RESULTS
We recruited 121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1). Group PM+ was delivered over five 2.5-3 hour sessions by trained and supervised gender-matched local non-specialists, with an average attendance of four out of five sessions. The quantitative and qualitative results demonstrated feasibility and acceptability for non-specialists to deliver Group PM+. Though the study was not powered to assess for effectiveness, for all five key outcome measures, including the primary clinical outcome, the estimated mean improvement was larger in the Group PM+ arm than the EUC arm.
CONCLUSION
The intervention and trial procedures were acceptable to participants, family members, and programme staff. The communities and participants found the intervention to be beneficial. Because feasibility and acceptability were established in this trial, a fully powered randomised controlled trial will be conducted for larger scale implementation to determine the effectiveness of the intervention in Nepal.",2020,Problem Management Plus,"['women and men in an earthquake-affected region of rural Nepal', 'adults in earthquake-affected communities in Nepal', '121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1']","['control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG', 'locally adapted Group PM', 'Group Problem Management Plus', 'PM']","['feasibility and acceptability', 'Acceptability', 'depression symptoms assessed using the Patient Health Questionnaire (PHQ-9']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013463', 'cui_str': 'Earthquake'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",121.0,0.0978027,Problem Management Plus,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sangraula', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': ""van 't Hof"", 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shrestha', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ghimire', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Marahatta', 'Affiliation': 'World Health Organization, Country Office for Nepal, Kathmandu, Nepal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'M J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000414']
3025,32454317,Web-based experiential learning strategies to enhance the evidence-based-practice competence of undergraduate nursing students.,"BACKGROUND
Evidence-based practice (EBP) is considered a key competence for practicing high-quality and safe nursing. However, undergraduate nursing programs continue to provide traditional classroom teaching strategies that have limitations in facilitating the development of critical competences for engaging in EBP in real clinical contexts.
OBJECTIVE AND DESIGN
The purpose of this study was to develop a web-based experiential learning program aimed at improving the engagement and experience of nursing students in EBP. A quasi-experimental research with non-equivalent control-group with non-synchronized design was used to describe the process of program development and the innovative learning method, and discuss the outcomes of the program.
METHODS
The experimental group was exposed to a web-based experiential learning program, while the control group received traditional learning with written material. Self-reported EBP scores (knowledge and skills, attitude, and practice) and clinical-questioning confidence were evaluated to assess the effects of the program.
RESULTS
The result showed that web-based experiential learning strategies were effective in significantly improving the EBP knowledge and skills score (F = 12.29, p = .001) and the score for confidence in asking clinical questions (F = 12.14, p = .001). The attitudes toward EBP (F = 0.75, p = .389) and practice score (F = 3.22, p = .076) did not show a significant difference between the experimental group and the control group.
CONCLUSION
The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students. Based on the study results, we suggest using web-based experiential learning to supplement the traditional learning method or as the mainstream learning method for nursing students.",2020,The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students.,"['undergraduate nursing students', 'nursing students in EBP']","['web-based experiential learning program, while the control group received traditional learning with written material']","['Self-reported EBP scores (knowledge and skills, attitude, and practice) and clinical-questioning confidence', 'practice score', 'EBP knowledge and skills score']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0182641,The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students.,"[{'ForeName': 'Myonghwa', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Chungnam National University, Republic of Korea.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Jeong', 'Affiliation': 'College of Nursing, Chungnam National University, Republic of Korea. Electronic address: miri9912@naver.com.'}, {'ForeName': 'Mihyun', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Daejeon Health Institute of Technology, Republic of Korea.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cullen', 'Affiliation': 'Department of Nursing Services and Patient Care, University of Iowa Hospitals and Clinics, United States of America.'}]",Nurse education today,['10.1016/j.nedt.2020.104466']
3026,32454920,"Perioperative Dexmedetomidine Fails to Improve Postoperative Analgesic Consumption and Postoperative Recovery in Patients Undergoing Lateral Thoracotomy for Thoracic Esophageal Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial.","Objectives
Dexmedetomidine is widely used as an adjunct to general anesthesia. In this study, we evaluated the effects of perioperative dexmedetomidine infusion on postoperative analgesia in patients undergoing lateral thoracotomy for thoracic esophageal cancer.
Methods
A total of 62 patients undergoing lateral thoracotomy for thoracic esophageal cancer were randomized to receive adjuvant therapy with either dexmedetomidine (0.5 μ g/kg intravenous bolus injection for 10 min before induction of anesthesia, followed by continuous infusion of 0.2-0.4 μ g/kg/h until the end of surgery, and 0.06 μ g/kg/h for 5 days after surgery) or equal volumes of saline. Acute postoperative pain was treated with patient-controlled intravenous sufentanil and flurbiprofen axetil. The primary outcomes of this study were the numbers of analgesic requirements in the first postoperative 72 h.
Results
Perioperative dexmedetomidine did not decrease the numbers of analgesic requirements in the first postoperative 72 h (dexmedetomidine group: 12.14 ± 4.76, saline group: 10.89 ± 5.66; p =0.367). Likewise, the groups did not differ with respect to total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life. Notably, dexmedetomidine had beneficial effects on decreasing intraoperative opioid consumption and improving postoperative sleep quality. Discussion . Perioperative dexmedetomidine has limited analgesic benefits in lateral thoracotomy for esophageal cancer when added to an opioid-based multimodal anesthetic regimen but can reduce opioid consumption.",2020,"Likewise, the groups did not differ with respect to total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life.","['62 patients undergoing lateral thoracotomy for thoracic esophageal cancer', 'Patients Undergoing Lateral Thoracotomy for Thoracic Esophageal Cancer', 'patients undergoing lateral thoracotomy for thoracic esophageal cancer']","['Placebo', 'flurbiprofen axetil', 'sufentanil', 'Dexmedetomidine', 'Perioperative Dexmedetomidine', 'Perioperative dexmedetomidine', 'perioperative dexmedetomidine infusion', 'dexmedetomidine']","['numbers of analgesic requirements', 'total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life', 'Postoperative Analgesic Consumption and Postoperative Recovery', 'postoperative sleep quality', 'Acute postoperative pain', 'intraoperative opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",62.0,0.395807,"Likewise, the groups did not differ with respect to total postoperative analgesic requirements, postoperative pain, perioperative inflammation, blood cell count, incidence of adverse events, surgical recovery (assessed at postoperative days 2 and 5 using the surgical recovery scale), length of hospital stay, hospital cost, incidence of chronic pain, or quality of life.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Department of Laboratory, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Life Sciences, University of Science and Technology of China, Huangshan Road 443, Hefei City, Anhui Province, China.'}, {'ForeName': 'Erwei', 'Initials': 'E', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Jixi Road 218, Hefei City, Anhui Province, China.'}]",Pain research & management,['10.1155/2020/4145893']
3027,32456702,The effect of information on prostate cancer screening decision process: a discrete choice experiment.,"BACKGROUND
Prostate cancer screening is controversial because of uncertainty about its benefits and risks. The aim of this survey was to reveal preferences of men concerning prostate cancer screening and to test the effect of an informative video on these preferences.
METHODS
A stated preferences questionnaire was sent by e-mail to men aged 50-75 with no history of prostate cancer. Half of them were randomly assigned to view an informative video. A discrete choice model was established to reveal men's preferences for six prostate cancer screening characteristics: mortality by prostate cancer, number of false positive and false negative results, number of overdiagnosis, out-of-pocket costs and recommended frequency.
RESULTS
A population-based sample composed by 1024 men filled in the entire questionnaire. Each attribute gave the expected sign except for overdiagnosis. The video seemed to increase the intention to abstain from prostate cancer screening.
CONCLUSIONS
The participants attached greater importance to a decrease in the number of false negatives and a reduction in prostate cancer mortality than to other risks such as the number of false positives and overdiagnosis. Further research is needed to help men make an informed choice regarding screening.",2020,The participants attached greater importance to a decrease in the number of false negatives and a reduction in prostate cancer mortality than to other risks such as the number of false positives and overdiagnosis.,"['A population-based sample composed by 1024 men filled in the entire questionnaire', 'A stated preferences questionnaire was sent by e-mail to men aged 50-75 with no history of prostate cancer']",[],"['prostate cancer mortality', 'number of false negatives']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205558', 'cui_str': 'False negative'}]",6.0,0.0371722,The participants attached greater importance to a decrease in the number of false negatives and a reduction in prostate cancer mortality than to other risks such as the number of false positives and overdiagnosis.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Charvin', 'Affiliation': 'Normandie Univ, UniCaen, Inserm, Anticipe, 14000, Caen, France. maud_charvin@yahoo.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Launoy', 'Affiliation': 'Normandie Univ, UniCaen, Inserm, Anticipe, 14000, Caen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Berchi', 'Affiliation': 'Normandie Univ, UniCaen, Inserm, Anticipe, 14000, Caen, France.'}]",BMC health services research,['10.1186/s12913-020-05327-x']
3028,32456704,Use of web-based game in neonatal resuscitation - is it effective?,"BACKGROUND
Knowledge and skills decline within months post simulation-based training in neonatal resuscitation. To empower 'Millennial' learners to take control of their own learning, a single-player, unguided web-based Neonatal Resuscitation Game was designed. The present study investigates the effectiveness of the game on retention of resuscitation knowledge and skills.
METHODS
The study evaluated 162 healthcare professionals who attended simulation-based training in neonatal resuscitation. Following standard simulation-based training, participants were assigned to either a gaming group (Gamers) with access to the web-based Neonatal Resuscitation Game or a control group (Controls) with no access to the game. Although Gamers were given access, game utilization was completely voluntary and at will. Some Gamers chose to utilize the web-based game (Players) and others did not (Non-players). Knowledge and skills in neonatal resuscitation were assessed upon completion of training and 6 months post-training using a multiple-choice question test and a manikin-based skills test. Changes in scores were compared statistically between Gamers vs Controls, Players vs Controls, and Players vs Controls + Non-players using two-sample t-tests.
RESULTS
At the final assessment, declines in knowledge scores were seen in all groups. Mean change from baseline in knowledge and skill performance scores at 6 months, adjusted for baseline skill performance and MCQ test scores, did not differ significantly between Players vs Controls and Players vs Controls + Non-players.
CONCLUSION
The web-based game in its current format may not be effective in facilitating retention of knowledge and technical skills in neonatal resuscitation.",2020,"At the final assessment, declines in knowledge scores were seen in all groups.","['162 healthcare professionals who attended simulation-based training in neonatal resuscitation', 'neonatal resuscitation']",['gaming group (Gamers) with access to the web-based Neonatal Resuscitation Game or a control group (Controls) with no access to the game'],"['baseline skill performance and MCQ test scores', 'knowledge and skill performance scores', 'knowledge scores']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",162.0,0.0302701,"At the final assessment, declines in knowledge scores were seen in all groups.","[{'ForeName': 'Cheo Lian', 'Initials': 'CL', 'LastName': 'Yeo', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore. yeo.cheo.lian@singhealth.com.sg.'}, {'ForeName': 'Selina Kah Ying', 'Initials': 'SKY', 'LastName': 'Ho', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Vina Canlas', 'Initials': 'VC', 'LastName': 'Tagamolila', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Arunachalam', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Srabani Samanta', 'Initials': 'SS', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Woei Bing', 'Initials': 'WB', 'LastName': 'Poon', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Mary Grace', 'Initials': 'MG', 'LastName': 'Tan', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Priyantha Ebenezer', 'Initials': 'PE', 'LastName': 'Edison', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}, {'ForeName': 'Wai Yan', 'Initials': 'WY', 'LastName': 'Yip', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Abdul Alim Abdul', 'Initials': 'AAA', 'LastName': 'Haium', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Pooja Agarwal', 'Initials': 'PA', 'LastName': 'Jayagobi', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Shrenik Jitendrakumar', 'Initials': 'SJ', 'LastName': 'Vora', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Simrita Kaur', 'Initials': 'SK', 'LastName': 'Khurana', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'John Carson', 'Initials': 'JC', 'LastName': 'Allen', 'Affiliation': 'Duke-NUS Medical School, Singapore 169857, Singapore.'}, {'ForeName': 'Ereno Imelda', 'Initials': 'EI', 'LastName': 'Lustestica', 'Affiliation': 'Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore 169608, Singapore.'}]",BMC medical education,['10.1186/s12909-020-02078-5']
3029,32457078,"Efficacy of maternal B 12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial.","INTRODUCTION
Vitamin B 12 deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B 12 deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.
METHODS AND ANALYSIS
This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring's neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant's biochemical B 12 status at age 9 months and maternal biochemical B 12 status in the first and third trimesters. Maternal biochemical B 12 status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.
ETHICAL CONSIDERATIONS AND DISSEMINATION
The study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits. Trial registration number CTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov).",2020,"This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal).","['Eligible mothers who give written consent', '720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal', 'vegetarian women for improving infant neurodevelopment']","['250 mcg methylcobalamin', 'maternal B 12 supplementation']","[""offspring's neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants"", ""infant's biochemical B 12 status at age 9 months and maternal biochemical B 12 status in the first and third trimesters""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}]",720.0,0.478247,"This double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal).","[{'ForeName': 'Jitender', 'Initials': 'J', 'LastName': 'Nagpal', 'Affiliation': 'Pediatrics, Sitaram Bhartia Institute of Science and Research, New Delhi, Delhi, India.'}, {'ForeName': 'Manu Raj', 'Initials': 'MR', 'LastName': 'Mathur', 'Affiliation': 'Public Health Foundation of India, New Delhi, India.'}, {'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Rawat', 'Affiliation': 'Pediatrics, Sitaram Bhartia Institute of Science and Research, New Delhi, Delhi, India.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Nagrath', 'Affiliation': 'Public Health Foundation of India, New Delhi, India.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Heys', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortina Borja', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Augustin', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Jageshwor', 'Initials': 'J', 'LastName': 'Gautam', 'Affiliation': ""Obstetrics and Gynaecology, Paropakar Maternity & Women's Hospital, Kathmandu, Nepal.""}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Pant', 'Affiliation': ""Obstetrics and Gynaecology, Paropakar Maternity & Women's Hospital, Kathmandu, Nepal.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Swabey', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Lakhanpaul', 'Affiliation': 'UCL GOS Institute of Child Health, University College London, London, UK m.lakhanpaul@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034987']
3030,32457082,"Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPOCH): study protocol of a randomised controlled, multicentre, superiority trial.","INTRODUCTION
Surgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI.
METHODS AND ANALYSIS
EPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmol l-1 ) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis.
ETHICS AND DISSEMINATION
Ethics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results.
TRIAL REGISTRATION NUMBER
Registered in the Dutch Trial Register: NL5572.",2020,"Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness.","['severe hyperglycaemia (>10 mmol l-1 ) and standardised surgical site handling', 'Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion', 'surgical site infections after elective abdominal surgery (EPOCH']","['EPOCH bundle added to (national) standard care', 'intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control', 'EPOCH added to standard care or standard care only']","['SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up', 'anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness', 'intention-to-treat basis']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0600472', 'cui_str': 'L1 Elements'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",,0.182783,"Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness.","[{'ForeName': 'Stijn W', 'Initials': 'SW', 'LastName': 'de Jonge', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Wolfhagen', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Quirine Jj', 'Initials': 'QJ', 'LastName': 'Boldingh', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Bom', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Posthuma', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Jochem Cg', 'Initials': 'JC', 'LastName': 'Scheijmans', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Bart Mf', 'Initials': 'BM', 'LastName': 'van der Leeuw', 'Affiliation': 'Department of Anesthesiology, Albert Schweitzer Hospital, Dordrecht, Noord-Holland, Netherlands.'}, {'ForeName': 'Joost Ab', 'Initials': 'JA', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, Zuid-Holland, Netherlands.'}, {'ForeName': 'Jens Peter', 'Initials': 'JP', 'LastName': 'Hering', 'Affiliation': 'Anesthesiology, Dijklander Ziekenhuis, Hoorn, Noord-Holland, Netherlands.'}, {'ForeName': 'Dirk Ja', 'Initials': 'DJ', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Surgery, Dijklander Ziekenhuis, Hoorn, Noord-Holland, Netherlands.'}, {'ForeName': 'Otto E', 'Initials': 'OE', 'LastName': 'van Geffen', 'Affiliation': 'Department of Anesthesiology, Tergooiziekenhuizen, Hilversum, Noord-Holland, Netherlands.'}, {'ForeName': 'Eduard R', 'Initials': 'ER', 'LastName': 'Hendriks', 'Affiliation': 'Department of Surgery, Tergooiziekenhuizen, Hilversum, Noord-Holland, Netherlands.'}, {'ForeName': 'Ewoud B', 'Initials': 'EB', 'LastName': 'Kluyver', 'Affiliation': 'Department of Anesthesiology, Rode Kruis Ziekenhuis, Beverwijk, Noord-Holland, Netherlands.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Demirkiran', 'Affiliation': 'Department of Surgery, Rode Kruis Ziekenhuis, Beverwijk, Noord-Holland, Netherlands.'}, {'ForeName': 'Luc Rcw', 'Initials': 'LR', 'LastName': 'van Lonkhuijzen', 'Affiliation': 'Department of Gynaecologic Oncology, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Slotema', 'Affiliation': ""Department of Anesthesiology, Jeroen Bosch Hospital, 's-Hertogenbosch, Noord-Brabant, Netherlands.""}, {'ForeName': 'Werner A', 'Initials': 'WA', 'LastName': 'Draaisma', 'Affiliation': ""Department of Surgery, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Noord-Brabant, Netherlands.""}, {'ForeName': 'Seppe Jsha', 'Initials': 'SJ', 'LastName': 'Koopman', 'Affiliation': 'Department of Anesthesiology, Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'van Rossem', 'Affiliation': 'Department of Surgery, Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Over', 'Affiliation': 'Department of Anesthesiology, Gelre Ziekenhuizen, Apeldoorn, Gelderland, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Duijvendijk', 'Affiliation': 'Department of Surgery, Gelre Ziekenhuizen, Apeldoorn, Gelderland, Netherlands.'}, {'ForeName': 'Marcel Gw', 'Initials': 'MG', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands.'}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Boermeester', 'Affiliation': 'Department of Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Noord-Holland, Netherlands m.a.boermeester@amsterdamumc.nl.'}]",BMJ open,['10.1136/bmjopen-2020-038196']
3031,32457083,"Faecal microbiota transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO): a prospective, randomised placebo-controlled feasibility trial.","INTRODUCTION
Antimicrobial resistance is rising, largely due to the indiscriminate use of antimicrobials. The human gut is the largest reservoir of antibiotic resistant bacteria (ARB). Individuals colonised with ARB have the potential to spread these organisms both in the community and hospital settings. Infections with ARB such as extended spectrum beta-lactamase producing enterobacteriales (ESBL-E) and carbapenemase producing enterobacteriales (CPE) are more difficult to treat and are associated with an increased morbidity and mortality. Presently, there is no effective decolonisation strategy for these ARB. Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach.
METHODS AND ANALYSIS
Prospective, randomised, patient-blinded, placebo-controlled feasibility trial of FMT to eradicate gastrointestinal carriage of ARB. Eighty patients with a recent history of invasive infection secondary to ESBL-E or CPE and persistent gastrointestinal carriage will be randomised 1:1 to receive encapsulated FMT or placebo. The primary outcome measure is consent rate (as a proportion of patients who fulfil inclusion/exclusion criteria); this will be used to determine if a substantive trial is feasible. Participants will be followed up at 1 week, 1 month, 3 months and 6 months and monitored for adverse events as well as gastrointestinal carriage rates of ARB after intervention.
ETHICS AND DISSEMINATION
Research ethics approval was obtained by London-City and East Research Ethics Committee (ref 20/LO/0117). Trial results will be published in a peer-reviewed journal and presented at international conferences.
TRIAL REGISTRATION NUMBER
ISRCTN registration number 34 467 677 and EudraCT number 2019-001618-41.",2020,"Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach.
","['number 34\u2009467', 'Eighty patients with a recent history of invasive infection secondary to ESBL-E or CPE and persistent gastrointestinal carriage', 'Faecal microbiota transplant (FMT', 'Faecal microbiota transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO']","['encapsulated FMT or placebo', 'FMT', 'placebo']","['consent rate', 'gastrointestinal carriage rates of ARB']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442886', 'cui_str': 'Secondary infection'}, {'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C1040967', 'cui_str': 'Order Enterobacterales'}, {'cui': 'C0246081', 'cui_str': 'carbapenemase'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}]","[{'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1444090', 'cui_str': 'Resistant bacteria'}]",80.0,0.359758,"Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach.
","[{'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Merrick', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""Primary Care and Public Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Allen', 'Affiliation': ""Pharmacy Department, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bisnauthsing', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Chi Chi', 'Initials': 'CC', 'LastName': 'Izundu', 'Affiliation': ""Care of Guy's and Saint Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': ""Department of Twin Research and Genetic Epidemiology, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Amos', 'Affiliation': 'National Institute for Biological Standards and Control, Potters Bar, UK.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ""Department of Infectious Diseases, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Shawcross', 'Affiliation': ""Institute of Liver Studies, Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Goldenberg', 'Affiliation': ""Centre for Clinical Infection and Diagnostics Research, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK Simon.Goldenberg@gstt.nhs.uk.""}]",BMJ open,['10.1136/bmjopen-2020-038847']
3032,32470574,Pharmacokinetic and bioequivalence study of new S-1 capsule in Chinese cancer patients.,"S-1 is a multicomponent capsule containing tegafur, gimeracil, and oteracil potassium that has shown anticancer activity against numerous tumor types. However, S-1 capsules from different manufacturing companies have shown variations in pharmacokinetics and safety. Therefore, this multicenter, single-dose, randomized-sequence, open-label, two-way, self-crossover study was conducted to evaluate the bioequivalence of a newly developed generic S-1 (New Times Pharmaceutical Co., Ltd., Shandong, China) and the original brand-name S-1 capsule (Taiho Pharmaceutical Co., Ltd., Japan). Furthermore, the safety profiles of both products were compared. A total of 70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals who were randomly and alternatively administered 50 mg of the reference and test S-1 with a 7-day interval. Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil were detected using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum drug concentration (C max ), time to achieve C max (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ) were determined using non-compartmental analysis with DAS2.0 software. Bioequivalence of the reference and test S-1 was evaluated according to 90% confidence intervals (CIs) for ratios of AUC and C max of S-1. Adverse events were evaluated by monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews. No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation. The 90% CIs of C max , AUC 0-t , and AUC 0-∞ ratios were within the 80%-125% limit. The generic S-1 caused eight mild adverse events including liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity. Similarly, 18 mild adverse events were observed including dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain. There were no differences in the adverse event incidence between the two formulations. In conclusion, the newly developed generic S-1 showed similar pharmacokinetics to those of an original brand-name S-1 in cancer patients, thereby indicating bioequivalence. Furthermore, both treatments were well tolerated, suggesting that the cost-effective generic S-1 should be considered as a feasible option when treating patients.",2020,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","['Chinese cancer patients', '70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals']",['new S-1 capsule'],"['adverse event incidence', 'liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity', 'pharmacokinetics and safety', 'Adverse events', 'Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil', 'dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain', 'monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews', 'maximum drug concentration (C max ), time to achieve C max (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ', 'plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0535459', 'cui_str': 'Gimeracil'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",70.0,0.0538582,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Yehui', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Phase I Clinical Trial Department of Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jianfu', 'Initials': 'J', 'LastName': 'Heng', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: hengjianfu@hnca.org.cn.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: lkunyan@163.com.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105384']
3033,32470635,Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial.,"Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI). Current ablative technologies that modify calcium to optimize stent deployment are limited by guidewire bias and periprocedural complications related to atheroembolization, coronary dissection, and perforation. Intravascular lithotripsy (IVL) delivers pulsatile ultrasonic pressure waves through a fluid-filled balloon into the vessel wall to modify calcium and enhance vessel compliance, reduce fibroelastic recoil, and decrease the need for high-pressure balloon (barotrauma) inflations. IVL has been used in peripheral arteries as stand-alone revascularization or as an adjunct to optimize stent deployment. STUDY DESIGN AND OBJECTIVES: Disrupt CAD III (clinicaltrials.gov identifier: NCT03595176) is a prospective, multicenter, single-arm study designed to assess safety and efficacy of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with de novo calcified coronary stenoses. The primary safety end point is freedom from major adverse cardiovascular events (composite of cardiac death, myocardial infarction, and target vessel revascularization) at 30 days compared to a prespecified performance goal. The primary effectiveness end point is procedural success without in-hospital major adverse cardiovascular events. Enrollment will complete early in 2020 with clinical follow-up ongoing for 2 years. CONCLUSION: Disrupt CAD III will evaluate the safety and effectiveness of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with calcified coronary stenoses.",2020,Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI).,"['severely calcified coronary stenoses', 'patients with de novo calcified coronary stenoses', 'patients with calcified coronary stenoses']","['coronary intravascular lithotripsy', 'Intravascular lithotripsy (IVL', 'Shockwave coronary IVL catheter', 'percutaneous coronary intervention (PCI']","['procedural success without in-hospital major adverse cardiovascular events', 'safety and efficacy', 'freedom from major adverse cardiovascular events (composite of cardiac death, myocardial infarction, and target vessel revascularization']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",,0.0335608,Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI).,"[{'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital and Lindner Research Center, Cincinnati, OH. Electronic address: Lindner@thechristhospital.com.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hill', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Beaux', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': 'Shockwave Medical, Santa Clara, CA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY; New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2020.04.005']
3034,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND
The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients.
PATIENTS AND METHODS
This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24.
RESULTS
Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG.
CONCLUSION
Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108']
3035,32471404,Effectiveness of a theory-based back care intervention on spine-related behavior among pupils: a school-based randomised controlled trial (T-Bak study).,"BACKGROUND
Children's health and welfare have a special place in research and policy in many countries. One of the most important concerns is the increasing rate of backache in children due to many of behavioral risk factors. The aim of this study was to evaluate the effectiveness of an educational program on promoting back-related behavior as well as knowledge, skills, beliefs, and self-efficacy among fifth grade girls.
METHODS
The theory-based back care (T-Bak) study was a school-based randomised controlled trial (RCT) that assessed the effectiveness of developing a back care training program based on the social cognitive theory (SCT). A total of 104 schoolchildren aged 11 ± 1.0 years were assigned to intervention (n = 52) and control (n = 52) groups. The intervention group received six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing. Then, the two groups were assessed for knowledge, skills, self-efficacy, beliefs, and behavior at four points in time: baseline, immediate, three and six-months post-intervention. The changes of the outcomes investigated using univariate repeated measures analysis of variance. Partial eta squared measure (η p 2 ) was used to calculate effect sizes.
RESULTS
A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2 = 0.22). Overall there were 36.4% improvement for knowledge (η p 2 = 0.21), 53.2% for the skills (η p 2 = 0.25), 19.5% for the self-efficacy (η p 2 = 0.11), and 25.6% for the beliefs (η p 2 = 0.14) scores from baseline to 6 months' follow-up assessments among the intervention group (p < 0.001). The results also showed a significant interaction effect between group and time.
CONCLUSION
The T-Bak intervention was effective in improving back-related behavior in pupils. It is now available and could be evaluated further in back-care related studies.
TRIAL REGISTRATION
Current Controlled Trials IRCT20180528039885N1, 30th Oct 2018, 'Prospectively registered'. https://www.irct.ir/trial/31534.",2020,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2 = 0.22).","['104 schoolchildren aged 11\u2009±\u20091.0\u2009years', 'spine-related behavior among pupils']","['theory-based back care intervention', 'six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing', 'educational program']","['rate of backache', 'knowledge, skills, self-efficacy, beliefs, and behavior', 'knowledge', 'knowledge, skills, beliefs, and self-efficacy']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204750', 'cui_str': 'Special back care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",104.0,0.0707787,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2 = 0.22).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari-Chehrehbargh', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Sedigheh Sadat', 'Initials': 'SS', 'LastName': 'Tavafian', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. Tavafian@modares.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Health Metrics Research Center, Iranian Institutes for Health Sciences Research, ACECR, Tehran, Iran. montazeri@acecr.ac.ir.'}]",BMC public health,['10.1186/s12889-020-08566-z']
3036,32471423,Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials.,"BACKGROUND
The comparative efficacy of inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist (ICS/LAMA/LABA) triple therapy administered via single or multiple inhalers in patients with chronic obstructive pulmonary disease (COPD) has not been evaluated comprehensively. We conducted two replicate trials comparing single- with multiple-inhaler ICS/LAMA/LABA combination in COPD.
METHODS
207608 and 207609 were Phase IV, 12-week, randomized, double-blind, triple-dummy non-inferiority trials comparing once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12 μg via metered-dose inhaler plus once-daily tiotropium (TIO) 18 μg via HandiHaler. Patients had symptomatic COPD and forced expiratory volume in 1 s (FEV 1 ) < 50% predicted, or FEV 1 < 80% predicted and ≥ 2 moderate or 1 severe exacerbations in the prior year. The primary endpoint in both trials was weighted mean change from baseline (wmCFB) in 0-24-h FEV 1 at Week 12. Secondary endpoints included CFB in trough FEV 1 at Day 84 and 85. Other endpoints included serial FEV 1 and health status outcomes at Week 12. Safety was evaluated descriptively.
RESULTS
The modified per-protocol population included 720 and 711 patients in studies 207608 and 207609 (intent-to-treat population: 728 and 732). FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV 1 at Week 12 (Study 207608 treatment difference [95% confidence interval]: 15 mL [- 13, 43]; Study 207609: 11 mL [- 20, 41]). FF/UMEC/VI improved trough FEV 1 CFB versus BUD/FOR+TIO at Day 84 and 85 (Day 85 treatment difference: Study 207608: 38 mL [10, 66]; Study 207609: 51 mL [21, 82]) and FEV 1 at 12 and 24 h post-morning dose at Week 12 in both studies. No treatment differences were seen in health status outcomes. Safety profiles were similar between treatments; pneumonia occurred in 7 (< 1%) patients with FF/UMEC/VI and 9 (1%) patients with BUD/FOR+TIO, across both studies.
CONCLUSIONS
FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV 1 at Week 12 in patients with COPD. Greater improvements in trough and serial FEV 1 measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen.
TRIAL REGISTRATION
GSK (207608/207609; NCT03478683/NCT03478696).",2020,"Greater improvements in trough and serial FEV 1 measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen.
","['207608 and 207609 were Phase IV', 'Study 207608: 38\u2009mL', '720 and 711 patients in studies 207608 and 207609 (intent-to-treat population: 728 and 732', '10, 66]; Study 207609: 51\u2009mL [21, 82]) and FEV 1 at 12 and 24\u2009h post-morning dose at Week 12 in both studies', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD: lung function and health status']","['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25\u2009μg via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12\u2009μg via metered-dose inhaler plus once-daily tiotropium', 'inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist (ICS/LAMA/LABA) triple therapy', 'Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy', 'single- with multiple-inhaler ICS/LAMA/LABA combination']","['symptomatic COPD and forced expiratory volume', 'health status outcomes', 'CFB in trough FEV', 'weighted mean change from baseline (wmCFB', 'Safety profiles', 'FF/UMEC/VI improved trough', 'pneumonia', 'serial FEV 1 and health status outcomes']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009002', 'cui_str': 'Clofibrate'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}]",,0.691451,"Greater improvements in trough and serial FEV 1 measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen.
","[{'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Compton', 'Affiliation': 'GlaxoSmithKline, Brentford, Middlesex, UK.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Corbridge', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Dorais', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fogarty', 'Affiliation': 'Spartanburg Medical Research, Spartanburg, SC, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline, Brentford, Middlesex, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sciurba', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Stiegler', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Chang-Qing', 'Initials': 'CQ', 'LastName': 'Zhu', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'Bernstein Clinical Research Center and Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, OH, USA. bernstdd@ucmail.uc.edu.'}]",Respiratory research,['10.1186/s12931-020-01360-w']
3037,32471469,Adapting the myPlan safety app to respond to intimate partner violence for women in low and middle income country settings: app tailoring and randomized controlled trial protocol.,"BACKGROUND
Intimate partner violence (IPV) is a leading threat to women's health and safety globally. Women in abusive relationships make critical decisions about safety and harm reduction while weighing multiple competing priorities, such as safety of children, housing and employment. In many low- and middle-income countries (LMIC), IPV prevention and response services are limited and women lack access to safety planning resources. In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities. This paper describes 1) the community-participatory formative process used to adapt the myPlan app content, interface, and implementation for the Kenya context, and 2) the randomized clinical trial study protocol for efficacy evaluation of myPlan Kenya.
METHODS
A community-participatory formative process engaged service providers and stakeholders, as well as IPV survivors for adaptation, followed by an in-depth pilot and final refinements. A randomized clinical trial design will then be used to determine efficacy of the myPlan Kenya app compared to standard care among women reporting IPV or fear of partner and living in an urban settlement. myPlan Kenya app provides and solicits information on a) relationship health; b) safety priorities; and c) severity of relationship violence. Based on the woman's inputs, the evidence-based algorithm developed for myPlan Kenya generates a tailored safety plan. Outcome measures are assessed at baseline, immediate post-intervention, and 3-month post-baseline. Difference-in-differences analysis compares primary (e.g. safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame) across timepoints by group.
DISCUSSION
Formative phase revealed high feasibility and acceptability of a technology-based intervention for safety planning in this LMIC setting. This phase generated essential refinements to myPlan Kenya app readability, content and implementation, including increased visualization of messaging, and implementation via community health volunteers (CHVs). The resulting trial will be the first to evaluate efficacy of a community-partnered technology-based IPV intervention in a LMIC. Our adaptation process and trial results will inform researchers and interventionists to integrate multiple data sources to adapt IPV intervention content and interface in settings where technology-based interventions for IPV are novel and literacy is limited.
TRIAL REGISTRATION
Pan African Clinical Trial Registry approval received 25 April 2018 (PACTR201804003321122); retrospectively registered.",2020,"In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities.","['Intimate partner violence (IPV', 'women in low and middle income country settings', 'women reporting IPV or fear of partner and living in an urban settlement']",['community-partnered\xa0technology-based IPV intervention'],"['safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}]",,0.147335,"In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities.","[{'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Decker', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA. mdecker@jhu.edu.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Wood', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA.'}, {'ForeName': 'S Rachel', 'Initials': 'SR', 'LastName': 'Kennedy', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Zaynab', 'Initials': 'Z', 'LastName': 'Hameeduddin', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tallam', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Akumu', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Wanjiru', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Asira', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Omondi', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Case', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Clough', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Otieno', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Mwiti', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perrin', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}]",BMC public health,['10.1186/s12889-020-08901-4']
3038,32471476,NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial.,"BACKGROUND
The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing a standard diabetes program in Nepal.
METHODS
We will conduct a two-arm, parallel group, stratified cluster randomized controlled trial of the NUrse-led COntinuum of care for people with Diabetes (N 1 = 200) and prediabetes (N 2 = 1036) (NUCOD) program, with primary care centers (9 outreach centers and 17 government health posts) as a unit of randomization. The NUCOD program will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared with the usual treatment group at 6 and 12 months of the intervention. The primary outcome will be the change in glycated hemoglobin (HbA1c) level among diabetes individuals and progression to type 2 diabetes among prediabetes individuals, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework. Outcomes will be analyzed on an intention-to-treat basis.
DISCUSSION
The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04131257. Registered on 18 October 2019.",2020,"The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context.
","['for people with Diabetes (N 1 \u2009=\u2009200) and prediabetes (N 2 \u2009=\u20091036) (NUCOD) program, with primary care centers (9 outreach centers and 17 government health posts', 'people with Diabetes and prediabetes (NUCOD) in Nepal']","['NUCOD program', 'NUrse-led COntinuum of care']","['glycated hemoglobin (HbA1c) level among diabetes individuals and progression to type 2 diabetes among prediabetes individuals, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",,0.128419,"The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context.
","[{'ForeName': 'Dong Roman', 'Initials': 'DR', 'LastName': 'Xu', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Rubee', 'Initials': 'R', 'LastName': 'Dev', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Department of Community Medicine, Kathmandu University School of Medical Sciences, Dhulikhel, Nepal.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts, Boston, MA, USA.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Pushpanjali', 'Initials': 'P', 'LastName': 'Shakya', 'Affiliation': 'Department of Community Medicine, Kathmandu University School of Medical Sciences, Dhulikhel, Nepal.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Prabin Raj', 'Initials': 'PR', 'LastName': 'Shakya', 'Affiliation': 'College of Dentistry, Biomedical Knowledge Engineer Lab, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Biraj Man', 'Initials': 'BM', 'LastName': 'Karmacharya', 'Affiliation': 'Department of Community Programs, Kathmandu University School of Medical Sciences, Dhulikhel Hospital, Kavre, Nepal. birajmk@kusms.edu.np.'}]",Trials,['10.1186/s13063-020-04372-5']
3039,32471477,"Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial.","BACKGROUND
More than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthritis suffer from debilitating symptoms, such as fatigue and pain, which can also be linked to sleep disturbance. It remains to be determined whether cognitive behavioural therapy for insomnia can be effective in patients with rheumatoid arthritis. The aim of the Sleep-RA trial is to investigate the efficacy of cognitive behavioural therapy for insomnia on sleep and disease-related symptoms in patients with rheumatoid arthritis. The primary objective is to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep efficiency from baseline to week 7 in patients with rheumatoid arthritis. The key secondary objectives are to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms from baseline to week 26 in patients with rheumatoid arthritis.
METHODS
The Sleep-RA trial is a randomised controlled trial with a two-group parallel design. Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity will be allocated 1:1 to treatment with cognitive behavioural therapy for insomnia or usual care. Patients in the intervention group will receive nurse-led, group-based cognitive behavioural therapy for insomnia once a week for 6 weeks. Outcome assessments will be carried out at baseline, after treatment (week 7) and at follow-up (week 26).
DISCUSSION
Data on treatment of insomnia in patients with rheumatoid arthritis are sparse. The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis. Because symptoms of rheumatoid arthritis and insomnia have many similarities, we also find it relevant to investigate the secondary effects of cognitive behavioural therapy for insomnia on fatigue, impact of rheumatoid arthritis, depressive symptoms, pain, functional status, health-related quality of life and disease activity. If we find cognitive behavioural therapy for insomnia to be effective in patients with rheumatoid arthritis this will add weight to the argument that evidence-based non-pharmacological treatment for insomnia in rheumatological outpatient clinics is eligible in accordance with the existing international guidelines on sleep.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03766100. Registered on 30 November 2018.",2020,The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis.,"['patients with rheumatoid arthritis', 'Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity', 'Patients with rheumatoid arthritis suffer from debilitating symptoms']","['Cognitive behavioural therapy', 'nurse-led, group-based cognitive behavioural therapy', 'cognitive behavioural therapy', 'cognitive behavioural therapy for insomnia or usual care']","['sleep\xa0onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms', 'sleep efficiency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",60.0,0.0802292,The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis.,"[{'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Latocha', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark. kristine.marie.latocha@regionh.dk.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Løppenthin', 'Affiliation': 'Department of Oncology, Research unit for Cancer Late Effect, CASTLE, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Jennum', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hetland', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Røgind', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lundbak', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Midtgaard', 'Affiliation': 'The University Hospitals Centre for Health Research, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Esbensen', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}]",Trials,['10.1186/s13063-020-04282-6']
3040,32471478,Evaluation of an intervention to support decisions on disclosure in the employment setting (DECIDES): study protocol of a longitudinal cluster-randomized controlled trial.,"BACKGROUND
Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searching for employment. Disclosure can lead to rejection and discrimination, but alternatively can also have important advantages that may be necessary to retain employment. Whether disclosure decisions lead to sustainable employment depends on many factors, of which unemployed people themselves can only influence their decision to disclose or not and the way in which they communicate. This study evaluates the cost-effectiveness of an intervention to support unemployed people with MHI in their disclosure decision and communication.
METHODS
This is a two-armed, clustered, randomized controlled trial with longitudinal design and randomization at organization level. An intervention will be examined, which consists of a disclosure decision aid tool (CORAL.NL) for unemployed people and workplace stigma-awareness training especially designed for employment specialists, which focusses on how to support unemployed people in their disclosure decisions. Participants in the intervention group are unemployed people who receive support from trained employment specialists from organizations allocated to the intervention group, and receive the CORAL.NL decision aid after baseline. The control group consists of unemployed people who receive support as usual from employment specialists from different organizations allocated to the control group. Primary outcomes are: cost-effectiveness of the intervention, e.g. healthcare costs, having employment, days until start of employment, independency of social security, having other forms of employment and decision making about disclosing MHI. Secondary outcomes are mental health and wellbeing, stigma and discrimination and work-related factors. Financial income data are collected via the registration systems of Dutch municipalities and Statistics Netherlands, and by questionnaires at baseline, and at 3, 6 and 12 months.
DISCUSSION
If using a decision aid to decide about disclosure of MHI leads to people finding and retaining employment more often, this study will contribute to lowering healthcare and societal costs.
TRIAL REGISTRATION
Netherlands Trial Register: NL7798. Registered on 4 June 2019.",2020,"BACKGROUND
Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searching for employment.",['unemployed people with MHI in their disclosure decision and communication'],['unemployed people who receive support as usual from employment specialists from different organizations allocated to the control group'],"['cost-effectiveness of the intervention, e.g. healthcare costs, having employment, days until start of employment, independency of social security, having other forms of employment and decision making about disclosing MHI', 'cost-effectiveness', 'mental health and wellbeing, stigma and discrimination and work-related factors']","[{'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.102735,"BACKGROUND
Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searching for employment.","[{'ForeName': 'K M E', 'Initials': 'KME', 'LastName': 'Janssens', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands. k.m.e.janssens@tilburguniversity.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Weeghel', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': ""Department of Health Services and Population Research, King's College London, London, UK.""}, {'ForeName': 'M C W', 'Initials': 'MCW', 'LastName': 'Joosen', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'E P M', 'Initials': 'EPM', 'LastName': 'Brouwers', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}]",Trials,['10.1186/s13063-020-04376-1']
3041,32471480,Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial.,"BACKGROUND
Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could be a useful therapeutic tool for health promotion. Thus, we aim to verify the effects of this intervention on muscle strength, muscle mass, fiber Pennation angle, fascicle length, functional performance, quality of life, and fall risk scores in this population.
METHODS
Thirty participants will be randomly distributed between 1) BFR-RT and 2) control (CTRL). Assessments will occur at three time points: before the training intervention (0 W), after 12 weeks (12 W), and at follow-up (24 W). The following variables will be assessed: Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length. The BFR-RT group will undergo 12 weeks of knee extension exercise (1 × 30 repetitions and 3 × 15 repetitions at 20% 1-RM and 50% of total blood flow occlusion pressure), with two sessions per week. Data normality will be assessed using the Shapiro-Wilk test. In case of normal distribution, a one-way repeated measures analysis of variance will be implemented to test for differences in baseline values. A mixed model then will be applied for each dependent variable. In case of non-normal data distribution, a Kruskal-Wallis test will be implemented to test for differences in baseline values. Next, the Friedman test will be used to analyze repeated measures. Within- and between-group effect sizes will be calculated using Cohen's d for each outcome. Finally, the minimal clinically important difference will be analyzed with distribution-based methods.
DISCUSSION
To our knowledge, this will be the first trial to investigate BFR-RT in patients with cirrhosis and evaluate the effects on neuromuscular parameters, functional performance, disease severity, and quality of life outcomes.
TRIAL REGISTRATION
Brazilian Clinical Trials Registry (ReBec): RBR-395mfw. Registered on 25 August 2018.",2020,"Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length.","['patients with cirrhosis', 'cirrhosis', 'Thirty participants will be randomly distributed between 1']","['BFR-RT and 2) control (CTRL', 'knee extension exercise', 'resistance training with blood flow restriction (BFR-RT', 'Resistance training combined with blood flow restriction']","['muscle strength, muscle mass, fiber Pennation angle, fascicle length, functional performance, quality of life, and fall risk scores', ""repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length"", 'neuromuscular parameters, functional performance, disease severity, and quality of life outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",30.0,0.0870044,"Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length.","[{'ForeName': 'Sanmy Rocha', 'Initials': 'SR', 'LastName': 'Nóbrega', 'Affiliation': 'MUSCULAB - Laboratory of Neuromuscular Adaptations to Resistance Training, Federal University of São Carlos - UFSCar, Rod. Washington Luiz, km 235 - SP 310, São Carlos, SP, CEP 13565-905, Brazil.'}, {'ForeName': 'Silvana Gama Florencio', 'Initials': 'SGF', 'LastName': 'Chachá', 'Affiliation': 'Department of Medicine, Federal University of São Carlos - UFSCar, Rod. Washington Luiz, km 235 - SP 310, São Carlos, SP, CEP 13565-905, Brazil.'}, {'ForeName': 'Cleiton Augusto', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'MUSCULAB - Laboratory of Neuromuscular Adaptations to Resistance Training, Federal University of São Carlos - UFSCar, Rod. Washington Luiz, km 235 - SP 310, São Carlos, SP, CEP 13565-905, Brazil. c.libardi@ufscar.br.'}]",Trials,['10.1186/s13063-020-04410-2']
3042,32471492,Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial.,"BACKGROUND
Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not yet been researched in the United Kingdom for primary care, which is where most people with depression are treated in the United Kingdom.
METHODS
This is a parallel-group cluster randomised trial with 1:1 allocation to intervention and control. Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria. Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded. The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later. General practitioners are trained in interpreting scores and asked to take them into account in their treatment decisions. Patients are given written feedback on scores and suggested treatments. The primary outcome measure is Depression on the Beck Depression Inventory BDI-II at 12 weeks. Secondary outcomes include BDI-II at 26 weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26 weeks, service use over 26 weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale). The sample includes 676 total participants from 113 practices across three centres. Randomisation is achieved by computerised sequence generation. Blinding is impossible given the nature of the intervention (self-report outcome measures prevent rating bias). Differences at 12 and 26 weeks between intervention and controls in depression, social functioning and quality of life are analysed using linear mixed models, adjusted for socio-demographics, baseline depression, anxiety, and clustering, while including practice as a random effect. Patient satisfaction, quality of life (QALYs) and costs over 26 weeks will be compared between arms. Qualitative process analysis includes interviews with 15-20 GP/NPs and 15-20 patients per arm to reflect trial results and implementation issues, using Normalization Process Theory as a theoretical framework.
DISCUSSION
If PROMs are helpful in improving patient outcomes for depression even to a small extent, then they are likely to be good value for money, given their low cost. The benefits could be considerable, given that depression is common, disabling, and costly.
TRIAL REGISTRATION
ISRCTN no: 17299295. Registered 1st October 2018.",2020,The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later.,"['Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria', 'primary care patients with depression (PROMDEP', '676 total participants from 113 practices across three centres', 'Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded']",['Patient Health Questionnaire (PHQ-9'],"['Patient satisfaction, quality of life (QALYs) and costs', 'BDI-II at 26\u2009weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26\u2009weeks, service use over 26\u2009weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26\u2009weeks (Medical Informant Satisfaction Scale', 'Depression on the Beck Depression Inventory BDI-II at 12\u2009weeks', 'depression, social functioning and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",,0.232089,The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later.,"[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Kendrick', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK. A.R.Kendrick@soton.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Leydon', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Guiqing', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, University Road Leicester, Leicester, LE1 7RH, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Rd, London, W1T 7NF, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Department of Health Services Research and Policy, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dewar-Haggart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dowrick', 'Affiliation': 'Institute of Psychology Health and Society, University of Liverpool, Liverpool, L69 3GL, UK.'}]",Trials,['10.1186/s13063-020-04344-9']
3043,32471494,High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial.,"BACKGROUND
Endoscopic retrograde cholangiopancreatography (ERCP) is an increasingly common intervention in the treatment of pancreaticobiliary disorders. Patients are often elderly with complex co-morbidities. While monitored anaesthesia care with sedation is commonly used for most cases, few would require general anaesthesia with an endotracheal tube. Both low-flow and high-flow nasal cannulas (HFNC) are established ways of delivering supplemental oxygen, but it is unclear whether one technique is better than the other. HFNC seems a promising tool for advanced procedures but evidence to support its application in high-risk ERCP cases is limited. The rate of oxygen desaturation during endoscopy has been reported to be as high as 11%-50% and the method of oxygen delivery for ERCP merits further study.
METHODS/DESIGN
This is a prospective, randomised, multicentre trial comparing the efficacy of oxygen supplementation through HFNC versus low-flow nasal cannula during ERCP, in a cohort of patients at risk of adverse respiratory events. A total of 132 patients will be recruited across three sites and randomly assigned to either the low-flow or the HFNC group. The primary outcome is the proportion of patients experiencing hypoxia, defined by any event of SpO2 < 90%. The secondary outcomes include parameters centred on oxygenation, requirement of airway manoeuvres, successful completion of procedure, perioperative complications, patient satisfaction and cost analysis of the consumables. An intention-to-treat principle will be applied while analysing.
DISCUSSION
The demand for ERCPs is likely to increase in the future with the aging population. Our study results may lead to improved outcomes and reduce airway-related complications in patients undergoing ERCPs. The results will be presented at national and international meetings and published in peer-reviewed journals.
TRIAL REGISTRATION
www.ANZCTR.org.au, CTRN12619000397112. Registered on 12 March 2019.",2020,A total of 132 patients will be recruited across three sites and randomly assigned to either the low-flow or the HFNC group.,"['patients undergoing ERCPs', 'patients at risk of adverse respiratory events', 'high risk cases (OTHER', '132 patients will be recruited across three sites and randomly assigned to either the low-flow or the HFNC group', 'Patients are often elderly with complex co-morbidities']","['low-flow and high-flow nasal cannulas (HFNC', 'oxygen supplementation through HFNC versus low-flow nasal cannula during ERCP', 'High-flow nasal cannula versus standard oxygen therapy assisting sedation', 'endoscopic retrograde cholangiopancreatography', 'Endoscopic retrograde cholangiopancreatography (ERCP', 'HFNC']","['rate of oxygen desaturation', 'parameters centred on oxygenation, requirement of airway manoeuvres, successful completion of procedure, perioperative complications, patient satisfaction and cost analysis of the consumables', 'proportion of patients experiencing hypoxia, defined by any event of SpO2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0010171', 'cui_str': 'Analysis, Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",132.0,0.173656,A total of 132 patients will be recruited across three sites and randomly assigned to either the low-flow or the HFNC group.,"[{'ForeName': 'Venkatesan', 'Initials': 'V', 'LastName': 'Thiruvenkatarajan', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia. Venkatesan.Thiruvenkatarajan@sa.gov.au.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Dharmalingam', 'Affiliation': 'Department of Anaesthesia, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Arenas', 'Affiliation': 'Discipline Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Medhat', 'Initials': 'M', 'LastName': 'Wahba', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Steiner', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia.'}, {'ForeName': 'Vasanth Rao', 'Initials': 'VR', 'LastName': 'Kadam', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Currie', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia.'}, {'ForeName': 'Roelof', 'Initials': 'R', 'LastName': 'Van Wijk', 'Affiliation': 'Discipline Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Quail', 'Affiliation': 'Human Physiology Anaesthesia and Intensive Care, School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Ludbrook', 'Affiliation': 'Discipline Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}]",Trials,['10.1186/s13063-020-04378-z']
3044,32471514,Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study.,"BACKGROUND
Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care.
AIMS AND OBJECTIVES
To conduct a mixed-methods process evaluation of the RCT, in line with Medical Research Council (MRC) process evaluation guidance, to inform interpretation of main trial findings and if the service is found to be effective and efficient, to inform subsequent implementation.
OBJECTIVES
1. To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time. 2. To explore the effects of individual intervention components on the primary outcomes. 3. To investigate the mechanisms of impact. 4. To describe the perceived effectiveness of relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training] from participant [general practitioner (GP), care home, PIP and resident/relative] perspectives. 5. To describe the characteristics of GP, care home, PIP and resident participants to assess reach. 6. To estimate the extent to which intervention delivery is normalised among the intervention healthcare professionals and related practice staff.
METHODS
A mix of quantitative (surveys, record reviews) and qualitative (interviews) approaches will be used to collect data on the extent of the delivery of detailed tasks required to implement the new service, to collect data to confirm the mechanism of impact as hypothesised in the logic model, to collect explanatory process and final outcome data, and data on contextual factors which could have facilitated or hindered effective and efficient delivery of the service.
DISCUSSION
Recruitment is ongoing and the trial should complete in early 2020. The systematic and comprehensive approach that is being adopted will ensure data is captured on all aspects of the study, and allow a full understanding of the implementation of the service and the RCT findings. With so many interrelated factors involved it is important that a process evaluation is undertaken to enable us to identify which elements of the service were deemed to be effective, explain any differences seen, and identify enablers, barriers and future adaptions.
TRIAL REGISTRATION
ISRCTN17847169. Date registered: 15 December 2017.",2020,"A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care.
",[],['relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training'],['effectiveness and cost-effectiveness'],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4542877', 'cui_str': 'Pharmacist prescriber'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0796992,"A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care.
","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Bond', 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, Scotland, UK. c.m.bond@abdn.ac.uk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': 'Leicester Medical School, University of Leicester, Leicester, UK.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Alldred', 'Affiliation': 'School of Healthcare, Baines Wing, University of Leeds, Leeds, UK.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Arthur', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Birt', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Blyth', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Desborough', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': 'Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Handford', 'Affiliation': 'Norfolk & Suffolk Primary and Community Care Research Office, hosted by South Norfolk Clinical Commissioning Group, Norwich, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Athena Care Homes, Unit 2 Rima House, A13 Approach, Ripple Road, Barking, Essex, IG11 0RH, UK.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hughes', 'Affiliation': ""School of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Vivienne', 'Initials': 'V', 'LastName': 'Maskrey', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Massey', 'Affiliation': 'Norfolk & Suffolk Primary and Community Care Research Office, hosted by South Norfolk Clinical Commissioning Group, Norwich, UK.'}, {'ForeName': 'Phyo K', 'Initials': 'PK', 'LastName': 'Myint', 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, Scotland, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Norris', 'Affiliation': 'School of Education & Lifelong Learning University of East Anglia, Norwich, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Poland', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Zermansky', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norwich, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04264-8']
3045,32302671,Editorial: Research in Real-World Settings: Challenging the Limits of Experimental Design.,"As underscored by Ponguta and colleagues in this issue of the Journal, 1 displacement secondary to war, poverty, and unsafe living conditions has affected large segments of the world's population, placing millions of children and their parents in highly stressful living conditions. Positive parenting, parenting that is warm, loving, and responsive to a child's needs, can mitigate the negative effects of early adversity and poverty on a child's behavioral, emotional, and cognitive development 2-4 and is one factor that can be targeted in otherwise almost immutable circumstances. Programs to support parents and to enhance positive parenting skills have proved effective across multiple countries and environments, including low- and middle-income countries 5 ; however, efforts to rigorously test these programs in areas of highest need and psychosocial instability are rare. By conducting a randomized controlled trial (RCT) of the Mother and Child Education Program (MOECP) in two refugee centers and one low-income community in Lebanon, Ponguta and colleagues defy this trend. Their work is an outstanding example of an effort to apply a rigorous scientific approach in a real-world setting underscoring both the value and the challenges inherent in this work.",2020,"By conducting a randomized controlled trial (RCT) of the Mother and Child Education Program (MOECP) in two refugee centers and one low-income community in Lebanon, Ponguta and colleagues defy this trend.","['two refugee centers and one low-income community in Lebanon, Ponguta and colleagues defy this trend']",['Mother and Child Education Program (MOECP'],[],"[{'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0040833', 'cui_str': 'trends'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]",[],,0.0251656,"By conducting a randomized controlled trial (RCT) of the Mother and Child Education Program (MOECP) in two refugee centers and one low-income community in Lebanon, Ponguta and colleagues defy this trend.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McCauley', 'Affiliation': ""University of Washington School of Medicine and Seattle Children's Hospital, Seattle. Electronic address: eliz@uw.edu.""}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Novins', 'Affiliation': 'University of Colorado School of Medicine, Aurora.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.04.002']
3046,31811497,"Comparison of the effect of photobiomodulation therapy and Ibuprofen on postoperative pain after endodontic treatment: randomized, controlled, clinical study.","The aim of the study was to compare the effect of Ibuprofen and the application of photobiomodulation therapy protocol on the reduction of postoperative pain in endodontically treated teeth using a randomized clinical trial design. Seventy patients, diagnosed with symptomatic irreversible pulpitis, were selected. Treatment was performed by a single operator; a reciprocal system was used to prepare the canals; they were obturated using the Tagger's hybrid technique and coronally sealed with glass-ionomer cement. After treatment, patients were randomly divided into 2 groups. In the active control group, two Ibuprofen 600 mg tablets were administered within a 12-h interval. In the photobiomodulation therapy group, the irradiation was applied after treatment. The evaluation of postoperative pain was performed by another researcher blinded to the groups at 6, 12, 24, and 72 h intervals after treatment. To measure the outcome, two pain scales were used: numerical rate scale (NRS) and verbal rate scale (VRS). Data were analyzed using the chi-square, Mann-Whitney, and Wilcoxon paired tests. Outcome was superior with photobiomodulation therapy at 6 h (p < 0.001), 12 h (p = 0.005), and 24 h (p < 0.001) intervals compared with Ibuprofen. The results for the 72 h (p = 0.317) interval were similar, both in the VRS and NRS scales. It may be concluded that the use of photobiomodulation therapy was effective in reducing pain within the first 24 h when compared with the administration of Ibuprofen 600 mg.",2020,"Outcome was superior with photobiomodulation therapy at 6 h (p < 0.001), 12 h (p = 0.005), and 24 h (p < 0.001) intervals compared with Ibuprofen.","['Seventy patients, diagnosed with symptomatic irreversible pulpitis']","['photobiomodulation therapy protocol', 'Ibuprofen', 'photobiomodulation therapy', 'photobiomodulation therapy and Ibuprofen', ""Tagger's hybrid technique and coronally sealed with glass-ionomer cement""]","['postoperative pain', 'numerical rate scale (NRS) and verbal rate scale (VRS', 'pain']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0399194,"Outcome was superior with photobiomodulation therapy at 6 h (p < 0.001), 12 h (p = 0.005), and 24 h (p < 0.001) intervals compared with Ibuprofen.","[{'ForeName': 'Eduardo Costa', 'Initials': 'EC', 'LastName': 'Nunes', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil.'}, {'ForeName': 'Fernando José', 'Initials': 'FJ', 'LastName': 'Herkrath', 'Affiliation': 'Leônidas & Maria Deane Institute, Oswaldo Cruz Foundation, Manaus, Brazil.'}, {'ForeName': 'Eduardo Hideki', 'Initials': 'EH', 'LastName': 'Suzuki', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil.'}, {'ForeName': 'Erivan Clementino', 'Initials': 'EC', 'LastName': 'Gualberto Júnior', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil.'}, {'ForeName': 'André Augusto Franco', 'Initials': 'AAF', 'LastName': 'Marques', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil.'}, {'ForeName': 'Emílio Carlos', 'Initials': 'EC', 'LastName': 'Sponchiado Júnior', 'Affiliation': 'Dental School, Federal University of Amazonas, R. Mins Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil. spemilio@ufam.edu.br.'}]",Lasers in medical science,['10.1007/s10103-019-02929-8']
3047,32473186,"The effects of GAMotion (a giant exercising board game) on physical capacity, motivation and quality of life among nursing home residents: A pilot interventional study.","BACKGROUND
In 2017, our team highlighted promising results of a giant exercising board game on physical activity level and a broader array of physical and psychological outcomes among nursing home residents. However, some improvements of this game were needed to make it more suitable for nursing homes and more challenging in terms of exercises. Therefore, we decided to develop a new version of a giant exercising board game: the GAMotion.
OBJECTIVES
The primary objective of this pilot study was to assess the impact of the GAMotion on physical capacity among nursing home residents. The secondary aims were to assess the impact of the GAMotion on motivation and quality of life in this population.
METHODS
A one-month pilot interventional study was performed in two comparable nursing homes. Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution. The GAMotion required participants to perform strength, flexibility, balance and endurance activities. The assistance provided by an exercising specialist decreased gradually during the intervention in an autonomy-oriented approach based on the self-determination theory. Physical capacity (i.e. fall risk using Tinetti test; dynamic balance using Timed Up and Go test (TUG); physical abilities using SPPB test; grip strength using Jamar dynamometer; isometric lower limb muscle strength using MicroFET2 and quantitative evaluation of walking using Locometrix), motivation (i.e. using Behavioral Regulation in Exercise Questionnaire-2) and quality of life (i.e. using EQ-5D questionnaire) were assessed at baseline and at the end of the intervention. A two-way repeated-measure analysis of variance (ANOVA) was used to assess time*group (intervention vs. control group) effects. All the analyses were adjusted on age, which differed significantly between the 2 groups at baseline.
RESULTS
During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group. No significant improvement was demonstrated on the other parameters.
CONCLUSION
These promising results should be interpreted with caution because of certain limitations (e.g. small sample size, no blind assessment). Further investigation is required to confirm and evaluate the long-term effectiveness of the GAMotion in nursing homes.",2020,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","['nursing home residents', 'Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution', 'two comparable nursing homes']","['GAMotion', 'GAMotion (a giant exercising board game']","['SPPB', 'TUG', 'intrinsic motivation', 'knee extensor isometric strength', 'motivation and quality of life', 'grip strength', 'physical capacity, motivation and quality of life', 'physical capacity', 'strength, flexibility, balance and endurance activities', 'quality of life (i.e. using EQ-5D questionnaire', 'Tinetti score', 'Physical capacity']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.028377,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Buckinx', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium. Electronic address: fanny.buckinx@uliege.be.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium; Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Lengelé', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Marchal', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Hurtrez', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mouton', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}]",Experimental gerontology,['10.1016/j.exger.2020.110983']
3048,32473355,TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial.,"Chronic kidney disease (CKD) is associated with an increased risk of acute coronary syndrome (ACS) and cardiovascular death. CKD patients suffering from ACS are exposed to an increased risk of thrombotic recurrences and a higher bleeding rate than patients with normal renal function. However, CKD patients are excluded or underrepresented in clinical trials. Therefore, determining the optimal antiplatelet strategy in this population is of utmost importance. We designed the TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome (TROUPER) trial: a prospective, controlled, multicenter, randomized trial to investigate the optimal P2Y12 antagonist in CKD patients with ACS. Patients with stage ≥3b CKD are eligible if the diagnosis of ACS is made and invasive strategy scheduled. Patients are randomized 1:1 between a control group with a 600-mg loading dose of clopidogrel followed by a 75-mg/d maintenance dose for 1 year and an experimental group with a 180-mg loading dose of ticagrelor followed by a 90-mg twice daily maintenance dose for the same duration. The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year. Safety will be evaluated by the bleeding rate (Bleeding Academic Research Consortium). To demonstrate the superiority of ticagrelor on major adverse cardiovascular events, we calculated that 508 patients are required. The aim of the TROUPER trial is to compare the efficacy of ticagrelor and clopidogrel in stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy. RCT# NCT03357874.",2020,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","['508 patients are required', 'CKD patients with ACS', 'CKD patients suffering from ACS', 'Patients with stage ≥3b', 'severe or terminal chronic kidney patients Undergoing', 'Chronic kidney disease (CKD', 'severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome', 'stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy']","['ticagrelor and clopidogrel', 'PERcutaneous coronary intervention', 'clopidogrel', 'TicagRelor Or Clopidogrel', 'ticagrelor']","['risk of thrombotic recurrences', 'rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year', 'bleeding rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0495371,"The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France. Electronic address: marc.laine@ap-hm.fr.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lemesle', 'Affiliation': ""Institut Cœur et Poumon, CHRU de Lille, Faculté de Médecine de l'Université de Lille, Unité INSERM UMR 1011, Lille, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Burtey', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France; Service de Néphrologie, Hôpital de la Conception, Assistance Publique des Hôpitaux de Marseille, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Département de Cardiologie, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'Département de Cardiologie, CHU Chartres, Chartres, France.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Quaino', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier Toulon, Toulon, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Canault', 'Affiliation': 'Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pankert', 'Affiliation': ""Service de Cardiologie, Centre Hospitalier d'Avignon, Avignon, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Paganelli', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Puymirat', 'Affiliation': 'Département de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris, Université Paris Descartes, INSERM U-970, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bonello', 'Affiliation': 'Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.'}]",American heart journal,['10.1016/j.ahj.2020.04.013']
3049,32473356,Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.,"BACKGROUND
Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y 12 receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting.
METHODS
Assessment of Loading with the P2Y 12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier).
CONCLUSION
ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.",2020,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"['patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290', 'patients with stable coronary artery disease who are planned for an elective PCI', '1,900 patients', 'patients undergoing elective percutaneous coronary intervention (PCI']","['Loading with the P2Y 12 inhibitor ticagrelor or clopidogrel', 'ticagrelor 180 mg or a loading dose of clopidogrel', 'aspirin', 'aspirin and ticagrelor 90 mg twice daily or clopidogrel']","['PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier', 'periprocedural ischemic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",1900.0,0.0455808,The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent.,"[{'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'CHU de Caen-Département de Cardiologie; Caen, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'CH de Chartres-Département de Cardiologie, Chartes, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Cardiology department, Nîmes university Hospital, Montpellier University, ACTION study group, Nîmes, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Jean-Guillaume', 'Initials': 'JG', 'LastName': 'Dillinger', 'Affiliation': 'Department of Cardiology, Inserm U942, Lariboisière Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris, Paris, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'CH de Bastia-Département de Cardiologie, Bastia, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Hôpital Privé Dijon Bourgogne-Cardiologie Interventionelle GCIDB VALMY, Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pouillot', 'Affiliation': 'Clinique Sainte Clotilde, La Réunion-Département de Cardiologie, La Réunion, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boccara', 'Affiliation': ""AP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Christiaens', 'Affiliation': 'CHU de Poitiers-Service de Cardiologie, Poitiers, France.'}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Labeque', 'Affiliation': 'GCS de Cardiologie de la Côte Basque, CH Bayonne, Bayonne, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Lhermusier', 'Affiliation': 'CHU de Toulouse-Département de Cardiologie, Toulouse, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Georges', 'Affiliation': 'CH de Versailles-Service de Cardiologie, Hôpital A. Mignot, Le Chesnay, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellemain-Appaix', 'Affiliation': ""CH d'Antibes Juan-Les-Pins-Département de Cardiologie, Antibes Juan-Les-Pins, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Le Breton', 'Affiliation': 'Univ Rennes, CHU Rennes, Inserm LTSI U1099, Rennes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'CHU Ambroise Paré (APHP), Université Versailles-Saint Quentin, ACTION study Group, INSERM-U1018 CESP, Boulogne, France-Service de Cardiologie.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Saint-Etienne', 'Affiliation': 'CHU Trousseau, Tours-Département de Cardiologie, Tours, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caussin', 'Affiliation': 'Institut Mutualiste Montsouris-Département de Cardiologie, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jourda', 'Affiliation': 'CH Auxerre-Département de Cardiologie, Auxerre, France.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': '3rd Faculty of Medicine, Charles University and Cardiocentre Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El Kasty', 'Affiliation': ""Grand Hôpital de l'Est Francilien site Marne-La-Vallée - Département de Cardiologie, Marne La Vallée, France.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Laredo', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Dumaine', 'Affiliation': 'Les Grands Prés Cardiac Rehabilitation center, Villeneuve St Denis, France.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), DHU FIRE, Hôpital Bichat, AP-HP, Université de Paris, Inserm U-1148, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique, ACTION Study Group, Hôpital Fernand Widal (AP-HP), Paris, France; SAMM - Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.017']
3050,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045']
3051,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES
This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR.
MATERIALS AND METHODS
Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices.
RESULTS
A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01).
CONCLUSIONS
The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110']
3052,32473563,Exercise improves neurotrophins in multiple sclerosis independent of disability status.,"BACKGROUND
To date, studies examining the effect of exercise on neurotrophic factors in MS are contradictory, and this may be explained, in part, by moderators such as disability status. To investigating the effect of a 12-week (3sessions/week) supervised multimodal exercise program on neurotrophic factors levels.
METHODS
Ninety four women with MS were randomly assigned into exercise or control conditions with randomization stratified by Expanded Disability Status Scale (EDSS) scores of low (EDSS< 4.5), moderate (4.5 ≤EDSS≤ 6), or high (EDSS≥ 6.5) disability. The exercise program comprised resistance, endurance, Pilates, balance and stretch exercises. Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI) were evaluated before and after the intervention period.
RESULTS
Exercise training improved brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels. The effect of exercise on NT-3 was dependent on disability status such that exercise groups with low and high disability had more pronounced changes compared with other condition. There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF). Aerobic capacity and one-repetition maximum, but not PCI, were improved with exercise independent of disability status.
CONCLUSIONS
Exercise can stimulate neurotrophic production and secretion, and this is generally not influenced by disability status. Exercise training may be an adjuvant for disease-modifying therapy among people with MS, and its effect may not be moderated by disability status.",2020,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,['Ninety four women with MS'],"['Exercise', 'Exercise training', 'multimodal exercise program', 'exercise program comprised resistance, endurance, Pilates, balance and stretch exercises']","['Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI', 'ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF', 'brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels', 'Disability Status Scale (EDSS) scores', 'Aerobic capacity and one-repetition maximum']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0207071', 'cui_str': 'Ciliary Neuronotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0083735', 'cui_str': 'Neurotrophin 3'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",94.0,0.0199456,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: banitalebi@sku.ac.ir.'}, {'ForeName': 'Majid Mardaniyan', 'Initials': 'MM', 'LastName': 'Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Raoof', 'Initials': 'R', 'LastName': 'Negaresh', 'Affiliation': 'Department of Physical Education & Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Department of Sport Sciences, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Performance and Health, Institute for Sport and Sport Science, Technical University Dortmund, Germany.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102143']
3053,31806214,Switching of Oral Anticoagulation Therapy After PCI in Patients With Atrial Fibrillation: The RE-DUAL PCI Trial Subanalysis.,"OBJECTIVES
The aim of this study was to assess if prior oral anticoagulant agent (OAC) use modifies the lower bleeding risk observed with dabigatran dual therapy (dabigatran twice daily plus a P2Y 12 inhibitor) versus warfarin triple therapy (warfarin plus a P2Y 12 inhibitor plus aspirin) in patients with atrial fibrillation who underwent percutaneous coronary intervention (PCI).
BACKGROUND
In the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial, the primary outcome of major bleeding or clinically relevant nonmajor bleeding was lower with dabigatran dual therapy versus warfarin triple therapy in patients with atrial fibrillation who underwent PCI.
METHODS
A total of 2,725 patients were randomized to dual therapy with dabigatran (110 or 150 mg twice daily) plus clopidogrel or ticagrelor or triple therapy with warfarin plus aspirin and clopidogrel or ticagrelor. Subgroup analysis compared risk for major bleeding or clinically relevant nonmajor bleeding and a composite thromboembolic endpoint in patients with prior OAC use and in those who were OAC treatment naive.
RESULTS
Risk for major bleeding or clinically relevant nonmajor bleeding was reduced with both dabigatran dual therapies compared with warfarin triple therapy in both the prior OAC use group (hazard ratios: 0.58 [95% confidence interval (CI): 0.42 to 0.81] and 0.61 [95% CI: 0.41 to 0.92] with 110 and 150 mg dabigatran, respectively) and the OAC-naive group (hazard ratios: 0.49 [95% CI: 0.38 to 0.63] and 0.76 [95% CI: 0.59 to 0.97] with 110 and 150 mg dabigatran) (p for interaction = 0.42 and 0.37, 110 and 150 mg dabigatran, respectively). The risk for thromboembolic events seemed similar with dabigatran dual therapy (both doses) and warfarin triple therapy across subgroups.
CONCLUSIONS
Bleeding risk was reduced with dabigatran dual therapy versus warfarin triple therapy in patients with atrial fibrillation after PCI, regardless of whether they were prior OAC users or OAC treatment naive. These results suggest that it is also safe to switch patients on OAC pre-PCI to dabigatran dual therapy post-PCI.",2019,"RESULTS
Risk for major bleeding or clinically relevant nonmajor bleeding was reduced with both dabigatran dual therapies compared with warfarin triple therapy in both the prior OAC use group (hazard ratios: 0.58 [95% confidence interval (CI): 0.42 to 0.81] and 0.61 [95% CI: 0.41 to 0.92] with 110 and 150 mg dabigatran, respectively) and the OAC-naive group (hazard ratios: 0.49 [95% CI: 0.38 to 0.63] and 0.76 [95% ","['Patients With Atrial Fibrillation', 'patients\xa0with atrial\xa0fibrillation after PCI, regardless of whether they were prior OAC users or OAC treatment naive', 'patients with atrial fibrillation who underwent percutaneous coronary intervention (PCI', 'patients with atrial fibrillation who underwent PCI', '2,725 patients', 'Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention']","['warfarin triple therapy', 'clopidogrel or ticagrelor or triple therapy with warfarin plus aspirin and clopidogrel or ticagrelor', 'dabigatran dual therapy (dabigatran twice daily plus a P2Y 12 inhibitor) versus warfarin triple therapy (warfarin plus a P2Y 12 inhibitor plus aspirin', 'Oral Anticoagulation Therapy', 'dual therapy with dabigatran', 'oral anticoagulant agent (OAC', 'Dabigatran Versus Triple Therapy With Warfarin']","['risk for thromboembolic events', 'Bleeding risk', 'Risk for major bleeding or clinically relevant nonmajor bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",2725.0,0.0648341,"RESULTS
Risk for major bleeding or clinically relevant nonmajor bleeding was reduced with both dabigatran dual therapies compared with warfarin triple therapy in both the prior OAC use group (hazard ratios: 0.58 [95% confidence interval (CI): 0.42 to 0.81] and 0.61 [95% CI: 0.41 to 0.92] with 110 and 150 mg dabigatran, respectively) and the OAC-naive group (hazard ratios: 0.49 [95% CI: 0.38 to 0.63] and 0.76 [95% ","[{'ForeName': 'Jurrien M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, the Netherlands. Electronic address: jurtenberg@gmail.com.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'de Veer', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, Paris, France; Université de Paris, Paris, France; INSERM U-1148, Paris, France; Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Dmitry A', 'Initials': 'DA', 'LastName': 'Zateyshchikov', 'Affiliation': 'Primary Vascular Department, City Clinic Hospital #51, Moscow, Russian Federation.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'Department of Cardiovascular Surgery, Faculty Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Ki-Bae', 'Initials': 'KB', 'LastName': 'Seung', 'Affiliation': 'The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.08.039']
3054,31806216,Dabigatran Dual Therapy Versus Warfarin Triple Therapy Post-PCI in Patients With Atrial Fibrillation and Diabetes.,"OBJECTIVES
The aim of this study was to evaluate dabigatran dual therapy versus warfarin triple therapy in patients with or without diabetes mellitus in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial.
BACKGROUND
It is unclear whether dual therapy is as safe and efficacious as triple therapy in patients with atrial fibrillation with diabetes following percutaneous coronary intervention.
METHODS
In RE-DUAL PCI, 2,725 patients with atrial fibrillation (993 with diabetes) who had undergone PCI were assigned to warfarin triple therapy (warfarin, clopidogrel or ticagrelor, and aspirin) or dabigatran dual therapy (dabigatran 110 mg or 150 mg twice daily and clopidogrel or ticagrelor). Median follow-up was 13 months. The primary outcome was the composite of major bleeding or clinically relevant nonmajor bleeding, and the main efficacy outcome was the composite of death, thromboembolic events, or unplanned revascularization.
RESULTS
Among patients with diabetes, the incidence of major bleeding or clinically relevant nonmajor bleeding was 15.2% in the dabigatran 110 mg dual therapy group versus 27.5% in the warfarin triple therapy group (hazard ratio [HR]: 0.48; 95% confidence interval [CI] 0.35 to 0.67) and 23.8% in the dabigatran 150 mg dual therapy group versus 25.1% in the warfarin triple therapy group (HR: 0.87; 95% CI: 0.62 to 1.22). Risk for major bleeding or clinically relevant nonmajor bleeding was also reduced with both dabigatran doses among patients without diabetes (dabigatran 110 mg dual therapy: HR: 0.54; 95% CI: 0.42 to 0.70; dabigatran 150 mg dual therapy: HR: 0.63; 95% CI: 0.48 to 0.83). Risk for the efficacy endpoint was comparable between treatment groups for both patients with and those without diabetes. No interaction between treatment and diabetes subgroup could be observed, either for bleeding or for composite efficacy endpoints.
CONCLUSIONS
In this subgroup analysis, dabigatran dual therapy had a lower risk for bleeding and a comparable rate of the efficacy endpoint compared with warfarin triple therapy in patients with atrial fibrillation with or without diabetes following percutaneous coronary intervention.",2019,Risk for major bleeding or clinically relevant nonmajor bleeding was also reduced with both dabigatran doses among patients without diabetes (dabigatran 110 mg dual therapy: HR: 0.54; 95% CI: 0.42 to 0.70; dabigatran 150 mg dual therapy: HR: 0.63; 95% CI: 0.48 to 0.83).,"['patients with diabetes', '2,725 patients with atrial fibrillation (993 with diabetes) who had undergone PCI', 'Patients With Nonvalvular Atrial Fibrillation', 'Patients', 'patients with or without diabetes mellitus in the RE-DUAL PCI (Randomized Evaluation of', 'patients with atrial fibrillation with diabetes following percutaneous coronary intervention', 'patients with atrial fibrillation with or without diabetes following percutaneous coronary intervention']","['Dabigatran Dual Therapy Versus Warfarin Triple Therapy Post-PCI', 'warfarin triple therapy (warfarin, clopidogrel or ticagrelor, and aspirin) or dabigatran dual therapy (dabigatran 110\xa0mg or 150\xa0mg twice daily and clopidogrel or ticagrelor', 'Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin', 'warfarin triple therapy']","['composite of major bleeding or clinically relevant nonmajor bleeding, and the main efficacy outcome was the composite of death, thromboembolic events, or unplanned revascularization', 'Risk for major bleeding or clinically relevant nonmajor bleeding', 'incidence of major bleeding or clinically relevant nonmajor bleeding', 'risk for bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",2725.0,0.0743746,Risk for major bleeding or clinically relevant nonmajor bleeding was also reduced with both dabigatran doses among patients without diabetes (dabigatran 110 mg dual therapy: HR: 0.54; 95% CI: 0.42 to 0.70; dabigatran 150 mg dual therapy: HR: 0.63; 95% CI: 0.48 to 0.83).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark. Electronic address: michael.maeng@ki.au.dk.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT, an F-CRIN Network, DHU FIRE, Hôpital Bichat, Paris, France; Université Paris Diderot, Paris, France; INSERM U_1148, Paris, France; Hôpital Bichat Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'HMS Analytical Software, Weimar (Lahn), Germany.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.07.059']
3055,31814476,PERson-centredness in hypertension management using information technology (PERHIT): a protocol for a randomised controlled trial in primary health care.,"Purpose: For primary health care (PHC), hypertension is the number one diagnosis for planned health care visits. The treatment of high blood pressure (BP) and its consequences constitutes a substantial economic burden. In spite of efficient antihypertensive medications, a low percentage of patients reach a well-controlled BP. The PERson-centredness in Hypertension management using Information Technology (PERHIT) Study is a multicentre randomised controlled trial. PERHIT is designed to evaluate the effect of supporting self-management on systolic blood pressure by the use of information technology in Swedish primary health care. Materials and Methods: After inclusion, 900 patients from 36 PHC centres are randomised to two groups. In the intervention group, patients are provided with a self-management support system including a home-BP monitor and further requested to perform self-reports and measure BP every evening for eight consecutive weeks. In the control group, patients receive treatment as usual. Results: The primary outcome will be the change in systolic blood pressure in patients with hypertension. In addition, person-centredness, daily life activities, awareness of risk and health care costs will also be evaluated. Conclusion: The results of this randomised controlled trial with assessment of blood pressure and same-day self-reports will provide patients a tool to understand the interplay between blood pressure and lifestyle applicable to primary health care. The self-management support system may be of importance for improved adherence to treatment and persistence to treatment recommendations.",2020,PERHIT is designed to evaluate the effect of supporting self-management on systolic blood pressure by the use of information technology in Swedish primary health care.,"['patients with hypertension', 'Swedish primary health care', '900 patients from 36 PHC centres']","['PERson-centredness in hypertension management using information technology (PERHIT', 'Information Technology (PERHIT']","['person-centredness, daily life activities, awareness of risk and health care costs', 'high blood pressure (BP', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021423', 'cui_str': 'Information Sciences'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",900.0,0.0871856,PERHIT is designed to evaluate the effect of supporting self-management on systolic blood pressure by the use of information technology in Swedish primary health care.,"[{'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Midlöv', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Bengtsson', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Wennersten', 'Affiliation': 'Clinical Studies Sweden - Forum South, Skåne University Health Care, Lund, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Malmqvist', 'Affiliation': 'Clinical Studies Sweden - Forum South, Skåne University Health Care, Lund, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Steen Carlsson', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Ranerup', 'Affiliation': 'Department of applied IT, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kjellgren', 'Affiliation': 'Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden.'}]",Blood pressure,['10.1080/08037051.2019.1697177']
3056,31814531,Comparative effectiveness of a standard behavioral and physical activity enhanced behavioral weight loss intervention in Black women.,"Black women typically lose small amounts of weight in behavioral weight loss interventions, partially due to low engagement in physical activity. Culturally relevant enhancement of the physical activity component may improve weight loss. This study compared the effectiveness of a culturally-relevant, physical activity-enhanced behavioral weight loss intervention to a standard behavioral weight loss intervention in Black women (n = 85) over 6 months. The study was conducted in two cohorts from March 2016 to February 2017 at the University of North Carolina at Chapel Hill. Participants had an average age of 48.30 ± 11.02 years with an average body mass index of 36.46 ± 4.50 kg/m 2 . Standard and enhanced groups' weight change (-2.83 kg and -2.08 kg, respectively) and change in physical activity (43.93 min/ week and 15.29 min/week, respectively) did not differ between groups. Significantly more standard group participants lost 5% of baseline weight compared to enhanced group participants. This study produced typical weight loss results in Black women. Behavioral weight loss treatment remains moderately effective for Black women. Strategies to increase attendance and self-monitoring, and the inclusion of cultural contexts to weight-related behaviors are needed to improve outcomes.",2020,"Standard and enhanced groups' weight change (-2.83 kg and -2.08 kg, respectively) and change in physical activity (43.93 min/ week and 15.29 min/week, respectively) did not differ between groups.","['Participants had an average age of 48.30 ± 11.02 years with an average body mass index of 36.46 ± 4.50 kg/m 2 ', 'two cohorts from March 2016 to February 2017 at the University of North Carolina at Chapel Hill', 'Black women', 'Black women (n = 85) over 6 months']","['Behavioral weight loss treatment', 'standard behavioral and physical activity enhanced behavioral weight loss intervention', 'culturally-relevant, physical activity-enhanced behavioral weight loss intervention', 'standard behavioral weight loss intervention']","['weight loss', 'physical activity', 'weight change']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0558275', 'cui_str': 'Chapel'}, {'cui': 'C0442532', 'cui_str': 'Hill'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",,0.0321959,"Standard and enhanced groups' weight change (-2.83 kg and -2.08 kg, respectively) and change in physical activity (43.93 min/ week and 15.29 min/week, respectively) did not differ between groups.","[{'ForeName': 'Loneke T', 'Initials': 'LT', 'LastName': 'Blackman Carr', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut , Storrs, Connecticut, USA.'}, {'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Samuel-Hodge', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Evenson', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Shrikant I', 'Initials': 'SI', 'LastName': 'Bangdiwala', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University , Hamilton, Ontario, Canada.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Health Behavior, Department of Nutrition, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}]",Women & health,['10.1080/03630242.2019.1700585']
3057,32477853,Text messaging and lottery incentive to improve colorectal cancer screening outreach at a community health center: A randomized controlled trial.,"Efforts to boost colorectal cancer (CRC) screening rates in underserved populations have been limited by effectiveness and scalability. We evaluate the impact of adding a lottery-based financial incentive to a text messaging program that asks patients to opt-in to receive mailed fecal immunochemical testing (FIT). This is a two-arm pragmatic randomized controlled trial at a community health center in Southwest Philadelphia from April to July 2017. We included CRC screening-eligible patients between ages 50-74 years who had a mobile phone, active health insurance, and at least one visit to the clinic in the past 12 months. Patients received a text message about CRC screening with the opportunity to opt-in to receive mailed FIT. They were randomized 1:1 to the following: (1) text messaging outreach alone (text), or (2) text messaging with lottery for a 1-in-5 chance of winning $100 after FIT completion (text + lottery). The primary outcome was the percentage of patients completing the mailed FIT within 3 months of initial outreach. 281 patients were included in the intent-to-treat analysis. The FIT completion rate was 12.1% (95% CI, 6.7%-17.5%) in the text message arm and 12.1% (95% CI, 6.7%-17.5%) in the lottery arm, with no statistical difference between arms. The majority of post-intervention interview respondents found text messaging to be acceptable and convenient. Opt-in text messaging is a feasible option to promote the uptake of mailed FIT screening, but the addition of a lottery-based incentive did not improve completion rates. Trial Registration: clinicaltrials.gov (NCT03072095).",2020,"The FIT completion rate was 12.1% (95% CI, 6.7%-17.5%) in the text message arm and 12.1% (95% CI, 6.7%-17.5%) in the lottery arm, with no statistical difference between arms.","['community health center in Southwest Philadelphia from April to July 2017', '281 patients were included in the intent-to-treat analysis', 'eligible patients between ages 50-74\xa0years who had a mobile phone, active health insurance, and at least one visit to the clinic in the past 12\xa0months']","['text messaging outreach alone (text), or (2) text messaging with lottery', 'lottery-based financial incentive to a text messaging program', 'Text messaging and lottery incentive to improve colorectal cancer screening outreach', 'CRC screening', 'text message about CRC screening']","['FIT completion rate', 'percentage of patients completing the mailed FIT within 3\xa0months of initial outreach']","[{'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",281.0,0.290046,"The FIT completion rate was 12.1% (95% CI, 6.7%-17.5%) in the text message arm and 12.1% (95% CI, 6.7%-17.5%) in the lottery arm, with no statistical difference between arms.","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Akinbowale', 'Initials': 'A', 'LastName': 'Oyalowo', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Dean', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McAuliffe', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Chyke A', 'Initials': 'CA', 'LastName': 'Doubeni', 'Affiliation': 'Center for Health Equity and Community Engagement Research, Mayo Clinic, United States.'}]",Preventive medicine reports,['10.1016/j.pmedr.2020.101114']
3058,32477909,Effect of high-volume hemofiltration on children with sepsis.,"Background
Sepsis has always been a challenge in pediatric intensive care unit (PICU) with poor prognosis. In order to evaluate the effect between routine continuous renal replacement therapy (CRRT) and high-volume hemofiltration (HVHF) in children with sepsis, we performed out this prospective, randomized, controlled, open-label trial.
Methods
Forty-seven children with sepsis were enrolled from January 2015 to December 2016. Twenty-two patients in Control group received routine CRRT and 25 patients in HVHF group received HVHF within 6 hours after the diagnosis of sepsis. The oxygenation index, serum creatinine, urea, lactate, inflammatory cytokines (IL-6, IL-10, and TNF-α), pediatric risk of mortality III (PRISM III) and 28-day mortality rate were collected and compared.
Results
The oxygenation index in HVHF group and Control group was significantly increased at 48 hours (P<0.01) and 72 hours after treatment (P<0.05). The same result of arterial lactate was observed. Serum creatinine, urea, IL-6, IL-10, TNF-α and PRISM III score were significantly ameliorated after 72 hours treatment in HVHF group (P<0.01), while there was no significant difference in Control group. After 72 hours of treatment, the oxygenation index, lactate, serum creatinine, urea, TNF-α, IL-6, IL-10 and PRISM III score in HVHF group were significantly improved compared with Control group (P<0.01). There is no significant difference on 28-day mortality between the two groups (P>0.05).
Conclusions
HVHF might be an effective treatment for children with sepsis.",2020,The oxygenation index in HVHF group and Control group was significantly increased at 48 hours (P<0.01) and 72 hours after treatment (P<0.05).,"['children with sepsis', 'Methods\n\n\nForty-seven children with sepsis were enrolled from January 2015 to December 2016']","['routine continuous renal replacement therapy (CRRT) and high-volume hemofiltration (HVHF', 'HVHF', 'routine CRRT', 'high-volume hemofiltration']","['Serum creatinine, urea, IL-6, IL-10, TNF-α and PRISM III score', 'oxygenation index', 'arterial lactate', '28-day mortality', 'oxygenation index, lactate, serum creatinine, urea, TNF-α, IL-6, IL-10 and PRISM III score', 'oxygenation index, serum creatinine, urea, lactate, inflammatory cytokines (IL-6, IL-10, and TNF-α), pediatric risk of mortality III (PRISM III) and 28-day mortality rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019014', 'cui_str': 'Hemofiltration'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0475502', 'cui_str': 'Pediatric risk of mortality'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",47.0,0.0490601,The oxygenation index in HVHF group and Control group was significantly increased at 48 hours (P<0.01) and 72 hours after treatment (P<0.05).,"[{'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Ning', 'Affiliation': ""Pediatric Intensive Care Unit, Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': ""Pediatric Intensive Care Unit, the Children's Hospital of Zhejiang University, School of Medicine, Shanghai 310052, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lyu', 'Affiliation': 'Department of Anesthesiology, Minhang Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yin', 'Affiliation': ""Pediatric Intensive Care Unit, Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China.""}, {'ForeName': 'Zhenjie', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Pediatric Intensive Care Unit, the Children's Hospital of Zhejiang University, School of Medicine, Shanghai 310052, China.""}]",Translational pediatrics,['10.21037/tp.2020.03.13']
3059,32477961,Significant Short-Term Shifts in the Microbiomes of Smokers With Periodontitis After Periodontal Therapy With Amoxicillin & Metronidazole as Revealed by 16S rDNA Amplicon Next Generation Sequencing.,"The aim of this follow-up study was, to compare the effects of mechanical periodontal therapy with or without adjunctive amoxicillin and metronidazole on the subgingival microbiome of smokers with periodontitis using 16S rDNA amplicon next generation sequencing. Fifty-four periodontitis patients that smoke received either non-surgical periodontal therapy with adjunctive amoxicillin and metronidazole (n = 27) or with placebos (n = 27). Subgingival plaque samples were taken before and two months after therapy. Bacterial genomic DNA was isolated and the V4 hypervariable region of the bacterial 16S rRNA genes was amplified. Up to 96 libraries were normalized and pooled for Illumina MiSeq paired-end sequencing with almost fully overlapping 250 base pairs reads. Exact ribosomal sequence variants (RSVs) were inferred with DADA2. Microbial diversity and changes on the genus and RSV level were analyzed with non-parametric tests and a negative binomial regression model, respectively. Before therapy, the demographic, clinical, and microbial parameters were not significantly different between the placebo and antibiotic groups. Two months after the therapy, clinical parameters improved and there was a significantly increased dissimilarity of microbiomes between the two groups. In the antibiotic group, there was a significant reduction of genera classified as Porphyromonas, Tannerella , and Treponema , and 22 other genera also decreased significantly, while Selenomonas, Capnocytophaga, Actinomycetes , and five other genera significantly increased. In the placebo group, however, there was not a significant decrease in periodontal pathogens after therapy and only five other genera decreased, while Veillonella and nine other genera increased. We conclude that in periodontitis patients who smoke, microbial shifts occurred two months after periodontal therapy with either antibiotics or placebo, but genera including periodontal pathogens decreased significantly only with adjunctive antibiotics.",2020,"Two months after the therapy, clinical parameters improved and there was a significantly increased dissimilarity of microbiomes between the two groups.","['Fifty-four periodontitis patients that smoke received either', 'smokers with periodontitis using 16S rDNA amplicon next generation sequencing', 'Smokers With Periodontitis']","['placebos', 'non-surgical periodontal therapy with adjunctive amoxicillin and metronidazole', 'Amoxicillin & Metronidazole', 'mechanical periodontal therapy with or without adjunctive amoxicillin and metronidazole', 'placebo']","['genera classified as Porphyromonas, Tannerella , and Treponema', 'Microbial diversity and changes on the genus and RSV level', 'Subgingival plaque samples', 'dissimilarity of microbiomes', 'periodontal pathogens']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1217351', 'cui_str': 'Tannerella'}, {'cui': 'C0040837', 'cui_str': 'Treponema'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}]",250.0,0.0157877,"Two months after the therapy, clinical parameters improved and there was a significantly increased dissimilarity of microbiomes between the two groups.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hagenfeld', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Matern', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Karola', 'Initials': 'K', 'LastName': 'Prior', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Harks', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eickholz', 'Affiliation': 'Department of Periodontology, Johann Wolfgang Goethe-University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Lorenz', 'Affiliation': 'Department of Periodontology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ti-Sun', 'Initials': 'TS', 'LastName': 'Kim', 'Affiliation': 'Section of Periodontology, Department of Conservative Dentistry, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kocher', 'Affiliation': 'Unit of Periodontology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Meyle', 'Affiliation': 'Department of Periodontology, University of Giessen, Giessen, Germany.'}, {'ForeName': 'Doğan', 'Initials': 'D', 'LastName': 'Kaner', 'Affiliation': 'Department of Periodontology, Dental School, Faculty of Health, University of Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schlagenhauf', 'Affiliation': 'Department of Periodontology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Harmsen', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ehmke', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}]",Frontiers in cellular and infection microbiology,['10.3389/fcimb.2020.00167']
3060,32477968,A potential prognostic model based on miRNA expression profile in The Cancer Genome Atlas for bladder cancer patients.,"Background
This study aimed to construct prognostic model by screening prognostic miRNA signature of bladder cancer.
Methods
The miRNA expression profile data of bladder cancer (BC) in The Cancer Genome Atlas (TCGA) were obtained and randomly divided into the training set and the validation set. Differentially expressed miRNAs (DEMs) between BC and normal control samples in the training set were firstly identified, and DEMs related to prognosis were screened by Cox Regression analysis. Then, the MiR Score system was constructed using X-Tile based cutoff points and verified in the validation set. The prognostic clinical factors are selected out by univariate and multivariate Cox Regression analysis. Finally, the mRNAs related to prognosis were screened and the biological pathway analysis was carried out.
Results
We identified the 7-miRNA signature was significantly associated with the patient's Overall Survival (OS). A prognostic model was constructed based on the prognostic 7-miRNA signature, and possessed a relative satisfying predicted ability both in the training set and validation set. In addition, univariate and multivariate Cox Regression analysis showed that age, lymphovascular invasion and MiR Score were considered as independent prognostic factors in BC patients. Furthermore, based on MiR Score prognostic model, several differentially expressed genes (DEGs), such as WISP3 and UNC5C , as well as their related biological pathway(s), including cell-cell adhesion and neuroactive ligand-receptor interaction, were considered to be related to BC prognosis.
Conclusion
The prognostic model which was constructed based on the prognostic 7-miRNA signature presented a high predictive ability for BC.",2020,"Furthermore, based on MiR Score prognostic model, several differentially expressed genes (DEGs), such as WISP3 and UNC5C , as well as their related biological pathway(s), including cell-cell adhesion and neuroactive ligand-receptor interaction, were considered to be related to BC prognosis.
","['bladder cancer (BC) in The Cancer Genome Atlas (TCGA', 'bladder cancer patients']",[],"['MiR Score system', 'lymphovascular invasion and MiR Score', ""patient's Overall Survival (OS""]","[{'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.023383,"Furthermore, based on MiR Score prognostic model, several differentially expressed genes (DEGs), such as WISP3 and UNC5C , as well as their related biological pathway(s), including cell-cell adhesion and neuroactive ligand-receptor interaction, were considered to be related to BC prognosis.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""1Anesthesiology Department, Jilin Univ, China Japan Union Hosp, 126 Xiantai St, Changchun, 130033 Jilin People's Republic of China.""}, {'ForeName': 'Dong Yan', 'Initials': 'DY', 'LastName': 'Zhu', 'Affiliation': ""2Vascular Surgery Department, Jilin Univ, China Japan Union Hosp, 126 Xiantai St, Changchun, 130033 Jilin People's Republic of China.""}, {'ForeName': 'Hong Jian', 'Initials': 'HJ', 'LastName': 'Xing', 'Affiliation': ""3Department of Orthopedics, Jilin Univ, China Japan Union Hosp, 126 Xiantai St, Changchun, 130033 Jilin People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ""4Department of Urology, Jilin Univ, China Japan Union Hosp, 126 Xiantai St, Changchun, 130033 Jilin People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""1Anesthesiology Department, Jilin Univ, China Japan Union Hosp, 126 Xiantai St, Changchun, 130033 Jilin People's Republic of China.""}]","Journal of biological research (Thessalonike, Greece)",['10.1186/s40709-020-00116-3']
3061,32478024,Strength Improvements of Different 10-Week Multicomponent Exercise Programs in Elderly Women.,"The purpose of this study was to analyze and compare the effects of various muscle strength sessions performed during 10 weeks physical conditioning programs and 4 weeks of detraining on the physical conditioning, body composition and hematology of elderly women. 48 women were randomly distributed in four groups: a physical conditioning group (PCG; n = 12) with two sessions per week; a PCG with an extra-session focus on hypertrophy (PCGH; n = 12), a PCG with an extra-session in a shallow pool (PCGP; n = 12); and a control group (CG; n = 12). PCGH achieved a significant increase in Abalakov. Significant differences between the CG and the other groups were found in Countermovement Jump. There were significant improvements in the chair-stand test in the PCG and PCGH. The training programs suspected improvements in HDL, LDL, baseline glucose and glycated hemoglobin. In conclusion, a training program with an extra-session focus on hypertrophy achieved a greater improvement in strength in elderly women.",2020,Significant differences between the CG and the other groups were found in Countermovement Jump.,"['Elderly Women', '48 women', 'elderly women']","['various muscle strength sessions', 'PCGH', 'physical conditioning group (PCG; n = 12) with two sessions per week; a PCG with an extra-session focus on hypertrophy (PCGH; n = 12), a PCG with an extra-session in a shallow pool (PCGP']","['chair-stand test', 'HDL, LDL, baseline glucose and glycated hemoglobin', 'Abalakov', 'Countermovement Jump']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",48.0,0.0120554,Significant differences between the CG and the other groups were found in Countermovement Jump.,"[{'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'González-Ravé', 'Affiliation': 'Department of Physical Activity and Sport Sciences, University of Castilla la Mancha, Toledo, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Cuéllar-Cañadilla', 'Affiliation': 'Department of Physical Activity and Sport Sciences, University of Castilla la Mancha, Toledo, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'García-Pastor', 'Affiliation': 'Department of Sport Sciences, University of Camilo Jose Cela, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Juárez Santos-García', 'Affiliation': 'Department of Physical Activity and Sport Sciences, University of Castilla la Mancha, Toledo, Spain.'}]",Frontiers in public health,['10.3389/fpubh.2020.00130']
3062,32478030,An Experimental Study of Effects of Media Implication on Self-Report Symptoms Related With MP Use.,"Along with gradually increases in mobile phone (MP) use, the mass media has played a vital role in informing the public regarding the potential health hazards of MP use. These media warnings have prompted public worries about health. The aim of the present study is to investigate the effects of media warnings about the possible health hazards of MP use on self-reported symptoms. Participants were 703 undergraduate students who volunteered to take part in an experimental study between August 2013 and July 2015. After completing baseline questionnaires containing information on demographics, MP usage and possible confounding variables, the participants were randomly clustered assigned to a video treatment group (watching a 5-min video about the possible health hazards of MP use) or a control group. Then, they completed another set of questionnaires containing 6 self-reported physical symptoms and the Beck Depression Inventory (BDI). Chi-squared tests, Mann-Whitney U -tests and logistic regression models were applied in the data analysis. Participants in the video group reported significantly more frequent headache ( P = 0.01), fatigue ( P = 0.00), memory loss ( P = 0.03), inattention ( P = 0.00), and higher level of depression ( P = 0.05) than those in the control group. Additionally, the prevalence of memory loss (β = 0.071, P = 0.03) and inattention (β = 0.110, P = 0.00) were significantly higher in participants with higher level of depression who watched the video. Media warnings about the possible health hazards of MP use promote people to report physical symptoms and psychological problems. Considering this tendency, more moderate and scientific media information is needed to alleviate public worries about MP use.",2020,"Participants in the video group reported significantly more frequent headache ( P = 0.01), fatigue ( P = 0.00), memory loss ( P = 0.03), inattention ( P = 0.00), and higher level of depression ( P = 0.05) than those in the control group.",['Participants were 703 undergraduate students who volunteered to take part in an experimental study between August 2013 and July 2015'],['video treatment group (watching a 5-min video about the possible health hazards of MP use) or a control group'],"['Chi-squared tests, Mann-Whitney', 'memory loss', 'prevalence of memory loss', 'fatigue', 'physical symptoms and the Beck Depression Inventory (BDI', 'level of depression', 'frequent headache']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4505320', 'cui_str': 'Mobile Phone Use'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0948396', 'cui_str': 'Frequent headache'}]",703.0,0.0264433,"Participants in the video group reported significantly more frequent headache ( P = 0.01), fatigue ( P = 0.00), memory loss ( P = 0.03), inattention ( P = 0.00), and higher level of depression ( P = 0.05) than those in the control group.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Occupational Health, Key Laboratory of Medical Protection for Electromagnetic Radiation, Ministry of Education, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Fei-Zhou', 'Initials': 'FZ', 'LastName': 'Zheng', 'Affiliation': 'General Hospital of Central Theater Command, Wuhan, China.'}, {'ForeName': 'Min-Di', 'Initials': 'MD', 'LastName': 'He', 'Affiliation': 'Department of Occupational Health, Key Laboratory of Medical Protection for Electromagnetic Radiation, Ministry of Education, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Occupational Health, Key Laboratory of Medical Protection for Electromagnetic Radiation, Ministry of Education, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Deng', 'Affiliation': 'Department of Occupational Health, Key Laboratory of Medical Protection for Electromagnetic Radiation, Ministry of Education, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Environmental Medicine, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Zheng-Ping', 'Initials': 'ZP', 'LastName': 'Yu', 'Affiliation': 'Department of Occupational Health, Key Laboratory of Medical Protection for Electromagnetic Radiation, Ministry of Education, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Occupational Health, Key Laboratory of Medical Protection for Electromagnetic Radiation, Ministry of Education, Third Military Medical University, Chongqing, China.'}]",Frontiers in public health,['10.3389/fpubh.2020.00175']
3063,32478133,A Pilot Intervention Study to Improve Sexuality Outcomes in Breast Cancer Survivors.,"Objective
The main objective of the study is to assess the efficacy of the Permission, Limited information, Specific Suggestion, and sexual therapy (PLISSIT) model directly with breast cancer survivor (BCS) on sexual function and quality of life (QOL) domains.
Methods
A pilot control trial was conducted comparing the PLISSIT model intervention to usual care. The intervention was delivered by two health professionals (nurse and professional sexual therapist) consisted of five sessions on counseling, genitalia anatomy, human sexual response, and sexual function. Data were collected before and 3 months after the intervention using the Female Sexual Function Index and the World Health Organization QOL-BREF questionnaire.
Results
The sample consisted of 19 BCS (11 intervention, 8 controls) with a mean age of 54.5 8 years (standard deviation = 7.14) and the majority were married, Black or mixed Brazilian, received chemotherapy, radiation and/or hormonal therapy, and education varied from high school to college. There was significant improvement in physical health ( P = 0.031), social relationships ( P = 0.046), orgasm ( P = 0.055), and pain ( P = 0.049) over time and the intervention resulted in improved arousal ( P = 0.038).
Conclusions
The results suggest that the PLISSIT model may be an effective intervention for BCS in coping with and managing changes in sexuality and sexual function after treatment. It is important that nurses are aware of sexual intimacy concerns for BCS and integrate assessment into their nursing care.",2020,"There was significant improvement in physical health ( P = 0.031), social relationships ( P = 0.046), orgasm ( P = 0.055), and pain ( P = 0.049) over time and the intervention resulted in improved arousal ( P = 0.038).
","['Breast Cancer Survivors', 'sample consisted of 19 BCS (11 intervention, 8 controls) with a mean age of 54.5 8 years (standard deviation = 7.14) and the majority were married, Black or mixed Brazilian, received']","['chemotherapy, radiation and/or hormonal therapy, and education varied from high school to college', 'sexual therapy (PLISSIT) model directly with breast cancer survivor (BCS']","['improved arousal', 'Female Sexual Function Index and the World Health Organization QOL-BREF questionnaire', 'social relationships', 'sexual function and quality of life (QOL) domains', 'Sexuality Outcomes', 'pain', 'physical health', 'sexuality and sexual function']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",19.0,0.0169444,"There was significant improvement in physical health ( P = 0.031), social relationships ( P = 0.046), orgasm ( P = 0.055), and pain ( P = 0.049) over time and the intervention resulted in improved arousal ( P = 0.038).
","[{'ForeName': 'Natalia Gondim', 'Initials': 'NG', 'LastName': 'de Almeida', 'Affiliation': 'Department of Nursing, State University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Tish M', 'Initials': 'TM', 'LastName': 'Knobf', 'Affiliation': 'School of Nursing, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Marcos Renato', 'Initials': 'MR', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Nursing, State University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Marina de Góes', 'Initials': 'MG', 'LastName': 'Salvetti', 'Affiliation': 'School of Nursing, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mônica Oliveira Batista', 'Initials': 'MOB', 'LastName': 'Oriá', 'Affiliation': 'Department of Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Ana Virginia de Melo', 'Initials': 'AVM', 'LastName': 'Fialho', 'Affiliation': 'Department of Nursing, State University of Ceara, Fortaleza, Ceará, Brazil.'}]",Asia-Pacific journal of oncology nursing,['10.4103/apjon.apjon_56_19']
3064,32478195,Pulmonary and cardiovascular safety of inhaled insulin in routine practice: The Exubera Large Simple Trial (VOLUME).,"Objective
VOLUME is a randomized, open-label, post-approval pragmatic trial aiming to evaluate long-term pulmonary and cardiovascular safety of Exubera® (EXU; insulin human [rDNA origin] Inhalation Powder) in routine clinical practice. The primary study objective is to compare risk of persistent decline in forced expiratory volume in 1 second (FEV 1 ) among patients treated with and without EXU.
Research design and methods
Patients eligible to take EXU per approved local label were randomized to EXU or routine care and followed per usual care, with scheduled FEV 1 tests at baseline, 6 months, and yearly.Randomization halted in October 2007 after Pfizer announced it would stop marketing EXU due to low sales. EXU patients were subsequently transitioned to usual care and all patients were followed for 6 additional months.
Results
Although there was insufficient power to evaluate the primary endpoint (37% of the planned 5,300 were randomized), the study provided important descriptive information.Per the primary endpoint definition, more EXU group patients (n = 8) experienced a persistent decline in FEV 1 (n = 0 in usual care). Using a broader, clinically relevant pre-specified supplementary definition of persistent decline, similar numbers were observed in the EXU (n = 27) and usual care (n = 24) groups. Slightly more pulmonary and allergic serious adverse event composite endpoints were seen in the EXU group. There were no consistent treatment group differences in the cardiovascular composite endpoint, all-cause mortality, or glycemic control.
Conclusions
Clinically important declines in lung function that persisted more than 60 days were uncommon and of similar frequency in Exubera and usual care.
Clinicaltrialsgov
NCT00359801.",2020,"There were no consistent treatment group differences in the cardiovascular composite endpoint, all-cause mortality, or glycemic control.
","['routine practice', 'patients treated with and without EXU', 'methods\n\n\nPatients eligible to take EXU per approved local label']","['EXU', 'inhaled insulin', 'Exubera® (EXU; insulin human [rDNA origin] Inhalation Powder']","['pulmonary and allergic serious adverse event composite endpoints', 'cardiovascular composite endpoint, all-cause mortality, or glycemic control']","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1176237', 'cui_str': 'Exubera'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C1176237', 'cui_str': 'Exubera'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1695970', 'cui_str': 'insulin human, rDNA origin'}, {'cui': 'C0991575', 'cui_str': 'Powder for inhalation'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",5300.0,0.144025,"There were no consistent treatment group differences in the cardiovascular composite endpoint, all-cause mortality, or glycemic control.
","[{'ForeName': 'Nicolle M', 'Initials': 'NM', 'LastName': 'Gatto', 'Affiliation': 'Epidemiology, Worldwide Safety & Regulatory, Pfizer, New York, NY, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Bracken', 'Affiliation': 'Yale University, Schools of Public Health and Medicine, New Haven, CT, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Kolitsopoulos', 'Affiliation': 'Epidemiology, Worldwide Safety & Regulatory, Pfizer, New York, NY, USA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Duggan', 'Affiliation': 'Global Product Development, Pfizer, Groton, CT, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Koch', 'Affiliation': 'University of North Carolina at Chapel Hill, Department of Biostatistics, Chapel Hill, NC, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins University School of Medicine, Pulmonary and Critical Care, Baltimore, MD, USA.'}, {'ForeName': 'Neville C', 'Initials': 'NC', 'LastName': 'Jackson', 'Affiliation': 'Global Product Development, Pfizer, Groton, CT, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100427']
3065,32478205,Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-Function Genotypes: Results of a Randomized Pharmacodynamic Study in a Feasibility Investigation of Rapid Genetic Testing.,"The feasibility of rapid genetic testing in patients undergoing percutaneous coronary intervention (PCI) and the comparison of the pharmacodynamic effects of prasugrel versus ticagrelor among carriers of cytochrome P450 2C19 loss-of-function alleles treated with PCI has been poorly explored. Rapid genetic testing using the Spartan assay was shown to be feasible and provides results in a timely fashion in a real-world setting of patients undergoing coronary angiography (n = 781). Among patients (n = 223, 28.5%), carriers of at least 1 loss-of-function allele treated with PCI (n = 65), prasugrel, and ticagrelor achieve similar levels of platelet inhibition. (A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients Undergoing PCI With CYP2C19 Loss-of-function [NCT02065479]).",2020,Rapid genetic testing using the Spartan assay was shown to be feasible and provides results in a timely fashion in a real-world setting of patients undergoing coronary angiography (n = 781).,"['Patients With CYP2C19 Loss-of-Function Genotypes', 'patients undergoing percutaneous coronary intervention (PCI', 'patients undergoing coronary angiography (n\xa0=\xa0781', 'Patients Undergoing PCI']","['prasugrel versus ticagrelor', 'Prasugrel Versus Ticagrelor', 'rapid genetic testing', 'PCI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",[],781.0,0.0366221,Rapid genetic testing using the Spartan assay was shown to be feasible and provides results in a timely fashion in a real-world setting of patients undergoing coronary angiography (n = 781).,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Franchi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Rollini', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Malhar', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Maryuri', 'Initials': 'M', 'LastName': 'Briceno', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Wali', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Nawaz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Silva', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Zubair', 'Initials': 'Z', 'LastName': 'Shaikh', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Maailiki', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Latonya', 'Initials': 'L', 'LastName': 'Been', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Pineda', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Suryadevara', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Soffer', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Zenni', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Bass', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}]",JACC. Basic to translational science,['10.1016/j.jacbts.2020.02.009']
3066,32478296,The effects of hyperventilation on seizure length and cerebral oxygenation during electroconvulsive therapy.,"OBJECTIVE
Previous studies have reported that hyperventilation prolongs seizure length. However, there is no clear consensus in clinical guidelines on how to perform hyperventilation during Electroconvulsive Therapy (ECT). The present study aims to investigate the effects of hyperventilation on seizure length and cerebral oxygenation.
METHODS
Forty patients aged 18-65 and classified as ASA I-II, who would have their first ECT course were included in the study. Ethics committee approval was obtained and all patients' consent was taken. The consecutive patients were randomized into two groups as follows: group H (20 patients; target etCO 2 : 25-30 mmHg) and group N (20 patients; target etCO 2 35-40 mmHg). All patients were ventilated with a facial mask for two minutes and later were ventilated by a laryngeal mask (LMA) for one minute. Vital signs, peripheric oxygen saturation (SpO 2 ), and regional oxygen saturation (rSO 2 ) were measured before general anesthesia induction, on the 3 rd minute of ventilation with an LMA (LMA 3 ), on the 1 st minute postictal (PI 1 ), on the 5 th (PI 5 ), and 10 th (PI 10 ) minutes. The motor seizure duration, Richmond sedation-agitation scale, and the time needed to reach Aldrete Score 9 were also recorded.
RESULTS
There was a significant difference between the groups when they were compared concerning seizure length and recovery time. However, when we compared the rSO 2 values that were measured at different times in group H, the difference between the measurements was statistically significant. When rSO 2 values in group H were compared in doubles, there were significant differences between measurements between the basal and LMA 3 , basal and PI 1 , and the basal and PI 5 . When Richmond agitation scores in both groups are compared, there were no significant differences between the groups.
CONCLUSION
This study found that seizure length was longer, and the recovery time was shorter in group H. There was a contribution of hyperventilation on cerebral oxygenation that was measured on the same person at different times, but cerebral oxygenation was not statistically different from patients that were normoventilated. More studies are required to form a consensus regarding how hyperventilation applies to ECT.",2020,There was a significant difference between the groups when they were compared concerning seizure length and recovery time.,"['Forty patients aged 18-65 and classified as ASA I-II, who would have their first ECT course were included in the study']","['hyperventilation', 'electroconvulsive therapy']","['seizure length and cerebral oxygenation', 'motor seizure duration, Richmond sedation-agitation scale, and the time needed to reach Aldrete Score', 'Vital signs, peripheric oxygen saturation (SpO 2 ), and regional oxygen saturation (rSO 2 ', 'seizure length and recovery time', 'cerebral oxygenation', 'recovery time', 'seizure length']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0751494', 'cui_str': 'Seizures, Convulsive'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1821424', 'cui_str': 'Post Anesthetic Recovery score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",40.0,0.051173,There was a significant difference between the groups when they were compared concerning seizure length and recovery time.,"[{'ForeName': 'Oguz', 'Initials': 'O', 'LastName': 'Gundogdu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cumhuriyet University Faculty of Medicine, Sivas, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Avci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cumhuriyet University Faculty of Medicine, Sivas, Turkey.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Gursoy', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cumhuriyet University Faculty of Medicine, Sivas, Turkey.'}, {'ForeName': 'Kenan', 'Initials': 'K', 'LastName': 'Kaygusuz', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cumhuriyet University Faculty of Medicine, Sivas, Turkey.'}, {'ForeName': 'Iclal Ozdemir', 'Initials': 'IO', 'LastName': 'Kol', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cumhuriyet University Faculty of Medicine, Sivas, Turkey.'}]",Northern clinics of Istanbul,['10.14744/nci.2019.70893']
3067,32456614,Effectiveness of a therapeutic multiple-lifestyle intervention taking into account the periconceptional environment in the management of infertile couples: study design of a randomized controlled trial - the PEPCI study.,"BACKGROUND
Infertility is defined as the inability to conceive after 12 months of unprotected intercourse. It affects approximately one in six couples seeking pregnancy in France or western countries. Many lifestyle factors of the couples' pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee, drugs, physical activity, stress, sleep…) have been identified as risk factors for infertility in both males and females. The high prevalence rates of unhealthy diets and lifestyles in the reproductive population of industrialized countries are worrisome. Nevertheless, adoption of a healthy lifestyle may improve fertility but lifestyle changes are difficult to achieve and to maintain due notably to behavioral factors.
METHODS
Consequently, we decided to propose an interventional study aimed at improving the quality of life of infertile couples before the start of assisted reproductive technology treatment. It is a randomized controlled multicentre trial. Both members of the couples are involved in an integrated global care program (PEPCI for ""Parcours Environnement PériConceptionnel en Infertilité"") vs. usual care. This global intervention not only considers diet and/or physical activity but follows a holistic approach, including a multidisciplinary assessment to address complete physical, psychological and social well-being. According to patient needs, this includes interventions on weight, exercise, diet, alcohol and drugs, mental and social health.
DISCUSSION
The main objective of trial is to demonstrate that periconceptional multidisciplinary care has a positive impact on reproductive functions. We will also focus on feasibility, acceptance, compliance and conditions of success of a multifaceted lifestyle intervention.
TRIAL REGISTRATION
The trial was registered at ClinicalTrials.gov, Identifier: NCT02961907 on November 11, 2016.",2020,The high prevalence rates of unhealthy diets and lifestyles in the reproductive population of industrialized countries are worrisome.,['infertile couples'],['therapeutic multiple-lifestyle intervention'],['quality of life'],"[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",6.0,0.0616562,The high prevalence rates of unhealthy diets and lifestyles in the reproductive population of industrialized countries are worrisome.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Dupont', 'Affiliation': 'Saint Antoine Research Center, INSERM équipe Lipodystrophies génétiques et acquises, Service de biologie de la reproduction-CECOS, AP-HP, Hôpital Tenon, Sorbonne Université, 4 rue de la Chine, F-75020, Paris, France. charlotte.dupont@aphp.fr.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Aegerter', 'Affiliation': 'Unité de Recherche Clinique et Département de Santé Publique, Assistance Publique - Hôpitaux de Paris, Hôpital Ambroise Paré, Boulogne, France.'}, {'ForeName': 'Aude-Marie', 'Initials': 'AM', 'LastName': 'Foucaut', 'Affiliation': 'Université Sorbonne Paris Nord, Laboratoire Educations et Pratiques de Santé, LEPS, UR 3412, F-93017, Bobigny, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Reyre', 'Affiliation': 'Department of Addiction Medicine and Psychiatry, APHP Avicenne University Hospital, Bobigny, France.'}, {'ForeName': 'François J', 'Initials': 'FJ', 'LastName': 'Lhuissier', 'Affiliation': 'Université Sorbonne Paris Nord, UMR INSERM 1272 Hypoxie et poumon, Bobigny, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bourgain', 'Affiliation': 'Department of Addiction Medicine and Psychiatry, APHP Avicenne University Hospital, Bobigny, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Chabbert-Buffet', 'Affiliation': 'Service de Gynécologie-Obstétrique et Médecine de La Reproduction, APHP Hôpital Tenon, 4 Rue de La Chine, 75020, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Cédrin-Durnerin', 'Affiliation': 'APHP Hôpital Jean verdier Service de médecine de la reproduction et préservation de la fertilité, avenue du 14-Juillet, 93143, Bondy, France.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Selleret', 'Affiliation': 'Service de Gynécologie-Obstétrique et Médecine de La Reproduction, APHP Hôpital Tenon, 4 Rue de La Chine, 75020, Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Cosson', 'Affiliation': 'Paris 13 University, Sorbonne Paris Cité, Assistance Publique - Hôpitaux de Paris, Avicenne Hospital, Department of Endocrinology-Diabetology-Nutrition, CRNH-IdF, CINFO, Bobigny, France.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lévy', 'Affiliation': 'Saint Antoine Research Center, INSERM équipe Lipodystrophies génétiques et acquises, Service de biologie de la reproduction-CECOS, AP-HP, Hôpital Tenon, Sorbonne Université, 4 rue de la Chine, F-75020, Paris, France.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-2855-9']
3068,32457373,Participatory practices at work change attitudes and behavior toward societal authority and justice.,"Generalized attitudes toward authority and justice are often conceptualized as individual differences that are resistant to enduring change. However, across two field experiments with Chinese factory workers and American university staff, small adjustments to people's experience of participation in the workplace shifted these attitudes one month later. Both experiments randomly assigned work groups to a 20-minute participatory meeting once per week for six weeks, in which the supervisor stepped aside and workers discussed problems, ideas, and goals regarding their work (vs. a status quo meeting). Across 97 work groups and 1,924 workers, participatory meetings led workers to be less authoritarian and more critical about societal authority and justice, and to be more willing to participate in political, social, and familial decision-making. These findings provide rare experimental evidence of the theoretical predictions regarding participatory democracy: that local participatory experiences can influence broader democratic attitudes and empowerment.",2020,"Across 97 work groups and 1,924 workers, participatory meetings led workers to be less authoritarian and more critical about societal authority and justice, and to be more willing to participate in political, social, and familial decision-making.",[],[],[],[],[],[],,0.0149299,"Across 97 work groups and 1,924 workers, participatory meetings led workers to be less authoritarian and more critical about societal authority and justice, and to be more willing to participate in political, social, and familial decision-making.","[{'ForeName': 'Sherry Jueyu', 'Initials': 'SJ', 'LastName': 'Wu', 'Affiliation': 'Collins Center A-415, Anderson School of Management, University of California Los Angeles, Los Angeles, CA, 90095, USA. sherry.wu@anderson.ucla.edu.'}, {'ForeName': 'Elizabeth Levy', 'Initials': 'EL', 'LastName': 'Paluck', 'Affiliation': '420 Peretsman Scully Hall, Department of Psychology, Princeton University, Princeton, NJ, 08544, USA.'}]",Nature communications,['10.1038/s41467-020-16383-6']
3069,32457492,Melatonin for Treatment-Seeking Alcohol Use Disorder patients with sleeping problems: A randomized clinical pilot trial.,"A high percentage of subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties. Lack of sleep could lead AUD patients to relapse or, sometimes, to suicide. Most of the currently prescribed medications to treat this complex problem retain a high risk of side effects and/or dependence. Therefore, the aim of the current clinical trial is to investigate the possibility of the use of a safer treatment, such as the natural health product melatonin, to treat alcohol-related sleeping problems. Sixty treatment-seeking AUD subjects were assigned to melatonin (5 mg) or placebo for 4 weeks of treatment. Change in sleeping quality which is the primary outcome of the study was assessed using the Pittsburgh sleep quality index (PSQI) scale. Linear mixed models were used to statistically analyze the difference in scores before and after 4 weeks of treatment. There was a reduction in the global PSQI score in both groups with no significant drug effect between groups. In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment. However, higher doses are worth exploring in future research.",2020,"In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment.","['subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties', 'Treatment-Seeking Alcohol Use Disorder patients with sleeping problems', 'Sixty treatment-seeking AUD subjects']","['Melatonin', 'melatonin', 'placebo']","['sleeping problems', 'global PSQI score', 'sleeping quality', 'Pittsburgh sleep quality index (PSQI) scale']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0808956,"In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment.","[{'ForeName': 'Marie N S', 'Initials': 'MNS', 'LastName': 'Gendy', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Lagzdins', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada.'}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'Schaman', 'Affiliation': 'Alcohol Research and Treatment Clinic, Acute Care Program, CAMH, Toronto, M6J 1H4, Ontario, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada. bernard.lefoll@camh.ca.'}]",Scientific reports,['10.1038/s41598-020-65166-y']
3070,32462791,"Prospective, Multicenter Feasibility Study to Evaluate Differential Target Multiplexed Spinal Cord Stimulation Programming in Subjects With Chronic Intractable Back Pain With or Without Leg Pain.","OBJECTIVE
This prospective, open-label, multicenter study evaluated the feasibility of spinal cord stimulation (SCS) therapy programming for chronic low back pain that uses multiple electrical pulsed signals (Differential Target Multiplexed).
METHODS
Twenty-five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States. The subjects evaluated standard and Differential Target Multiplexed programs, each for 4 ± 1 days. A commercially available SCS trial system was used for standard SCS therapy programming. During the trialing of the multiplexed programs, implanted temporary leads were connected to an investigational external trial stimulator system.
RESULTS
Twenty subjects concluded the study. The mean baseline numeric pain rating scale (NPRS) score for low back pain was 7.4, with a mean age of 62.4 years and mean pain duration of 18.0 years. Significant relief in back pain was observed for both treatments, with significantly better response with multiplexed programming. At the end of the trial period, subjects reported a reduction in their mean NPRS score from baseline to 4.2 after standard programming and to 2.4 after Differential Target Multiplexed programming. The difference between standard and multiplexed programming was significant. The responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming. Eighty-five percent of subjects who evaluated both programming approaches preferred Differential Target Multiplexed SCS.
CONCLUSION
In this difficult-to-treat patient population, subjects reported significant reduction in chronic back pain when using multiplexed programming. A randomized clinical trial is needed to confirm the results from this feasibility study.",2020,Responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming.,"['Subjects with Chronic Intractable Back Pain with or Without Leg Pain', 'Twenty subjects concluded the study', 'Twenty-five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States']","['spinal cord stimulation (SCS) therapy programming', 'Differential Target Multiplexed SCS Programming']","['Responder rate for low back pain relief', 'NPRS', 'chronic back pain', 'Mean baseline numerical pain rating score (NPRS', 'back pain']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443199', 'cui_str': 'Differential'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",20.0,0.0338046,Responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Fishman', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, Pennsylvania, U.S.A.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Calodney', 'Affiliation': 'Precision Spine Care, Tyler, Texas, U.S.A.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, Pennsylvania, U.S.A.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Slezak', 'Affiliation': 'Interventional Spine Medicine, Barrington, New Hampshire, U.S.A.'}, {'ForeName': 'Ramsin', 'Initials': 'R', 'LastName': 'Benyamin', 'Affiliation': 'Millennium Pain Center, Bloomington, Illinois, U.S.A.'}, {'ForeName': 'Atiq', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Decatur Memorial Hospital, Decatur, Illinois, U.S.A.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Millennium Pain Center-Libertyville, Libertyville, Illinois, U.S.A.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Swedish Medical Center, Seattle, Washington, U.S.A.'}, {'ForeName': 'Asteghik', 'Initials': 'A', 'LastName': 'Hacobian', 'Affiliation': 'Interventional Spine Medicine, Barrington, New Hampshire, U.S.A.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Griffith', 'Affiliation': 'Precision Spine Care, Tyler, Texas, U.S.A.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Swedish Medical Center, Seattle, Washington, U.S.A.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Vallejo', 'Affiliation': 'Millennium Pain Center, Bloomington, Illinois, U.S.A.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12908']
3071,32459944,"Health Care Hotspotting - A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.210005,,"[{'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Edwards', 'Affiliation': 'Veterans Affairs Portland Health Care System, Portland, OR edwarsam@ohsu.edu.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}]",The New England journal of medicine,['10.1056/NEJMc2001920']
3072,32459945,"Health Care Hotspotting - A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.210005,,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': 'UPMC Insurance Services Division, Pittsburgh, PA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Peele', 'Affiliation': 'UPMC Insurance Services Division, Pittsburgh, PA.'}, {'ForeName': 'Diane P', 'Initials': 'DP', 'LastName': 'Holder', 'Affiliation': 'UPMC Insurance Services Division, Pittsburgh, PA.'}]",The New England journal of medicine,['10.1056/NEJMc2001920']
3073,32459946,"Health Care Hotspotting - A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.210005,,"[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Stevens', 'Affiliation': 'Milken Institute School of Public Health, Washington, DC mordecai@gwu.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2001920']
3074,32459947,"Health Care Hotspotting - A Randomized, Controlled Trial. Reply.",,2020,,[],[],['Health Care'],[],[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.196298,,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, MA afink@mit.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taubman', 'Affiliation': 'National Bureau of Economic Research, Cambridge, MA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Doyle', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, MA.'}]",The New England journal of medicine,['10.1056/NEJMc2001920']
3075,32460179,Preclinical profile and phase I clinical trial of a novel androgen receptor antagonist GT0918 in castration-resistant prostate cancer.,"PURPOSE
We conducted preclinical experiments and phase I clinical trial to investigate the safety, pharmacokinetics (PK) and antitumour effects of GT0918 in castration-resistant prostate cancer (CRPC).
EXPERIMENTAL DESIGN
An androgen receptor (AR) competitive binding assay was performed, followed by evaluation of GT0918 on AR protein expression. The efficacy of GT0918 was investigated in a castration-resistant xenograft model. A phase I dose-escalation study of GT0918 in CRPC was also carried out to evaluate its safety, PK and antitumour efficacy.
RESULTS
GT0918 was demonstrated to inhibit the binding of androgen to AR more potently than MDV3100, and to effectively reduce the AR protein level. GT0918 inhibited the transcriptional activity of wild-type AR and AR with clinically relevant ligand-binding domain mutations. Furthermore, GT0918 significantly inhibited the growth of prostate cancer. A total of 16 patients was treated with GT0918 at five dose levels. Among these 16 patients, 10 and 2 patients, respectively, completed a three-cycle and six-cycle treatment, in which MTD was not reached. All the treatment-related adverse events were grade I, including hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia. PK parameters showed that drug exposure increased with dose proportionally from 50 to 300 mg and a saturation was observed between 300 and 400 mg. PSA declines of ≥30% and ≥50% were, respectively, observed in six and two cases. All the 12 patients with metastatic soft tissue lesions confirmed stable disease.
CONCLUSIONS
GT0918, a full AR antagonist without agonist effect, has high binding affinity to AR with AR protein down-regulation activity. GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC. CLINICALTRIALS: gov identifier CTR20150501.",2020,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"['castration-resistant prostate cancer (CRPC', 'castration-resistant prostate cancer', '12 patients with metastatic soft tissue lesions confirmed stable disease']",['novel androgen receptor antagonist GT0918'],"['safety, pharmacokinetics (PK) and antitumour effects', 'growth of prostate cancer', 'PSA declines', 'AR protein level', 'safety, PK\xa0and antitumour efficacy', 'transcriptional activity of wild-type AR and AR', 'hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia']","[{'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0410013', 'cui_str': 'Soft tissue lesion'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936804', 'cui_str': 'Androgen Receptor Antagonists'}, {'cui': 'C4043276', 'cui_str': 'GT0918'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",16.0,0.014045,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"[{'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Honghua', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Fubo', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qianxiang', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Shancheng', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Chunyun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China. Electronic address: cychen@kintor.com.cn.'}, {'ForeName': 'Yinghao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: sunyhsmmu@126.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.013']
3076,32460220,Ultrasound imaging evaluation of structural and textural features in asymptomatic achilles tendons in pre-professional dancers: A cross-sectional study.,"OBJECTIVE
To evaluate performance descriptors, sociodemographics variables and tendon echogenicity of asymptomatic Achilles tendons and to compare the echotexture from different classification subgroups.
DESIGN
A prospective, randomized cross-sectional study was carried out.
SETTING
laboratory of university.
PARTICIPANTS
Forty-two Achilles tendons (AT) were recruited from pre-professional dancers. Based on the echogenicity pattern, the sample was divided into two groups (n = 21, Heterogeneous group; n = 21, Homogeneous group).
MAIN OUTOCOME MEASURES
Ultrasound images and ImageJ measurements were performed to evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test were measured as performance parameter.
RESULTS
EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups. AT-TH, endurance test, balance test, years of dance, training hours per week and average pointe hours per week did not showed differences between groups. A multivariate prediction model between groups and the echotexture variables (EI (R 2 = 0.569; EV (R 2 = 0.341)) were determined.
CONCLUSION
Asymptomatic AT of heterogeneous group showed a lower EI and a higher EV compared to homogeneous group. Tendon echogenicity did not interact with performance variables.",2020,"RESULTS
EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","['laboratory of university', 'Forty-two Achilles tendons (AT) were recruited from pre-professional dancers', 'asymptomatic achilles tendons in pre-professional dancers']",[],"['evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test', 'Tendon echogenicity']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]",[],"[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",,0.0279145,"RESULTS
EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: bcruz@us.es.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Barrera-García-Martín', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: irebargar@gmail.com.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Almazán-Polo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: jaime.almazan@universidadeuropea.es.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Jaén-Crespo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: gjaencrespo@gmail.com.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: carlos.romero@universidadeuropea.es.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.05.008']
3077,32460459,Effectiveness of nivolumab versus regorafenib in hepatocellular carcinoma patients who failed sorafenib treatment.,"Background/Aims
Several treatment options are currently available for patients with hepatocellular carcinoma (HCC) failing previous sorafenib treatment. We aimed to compare the effectiveness of regorafenib and nivolumab in these patients.
Methods
Consecutive HCC patients who received regorafenib or nivolumab after failure of sorafenib treatment were included. Primary endpoint was overall survival (OS) and secondary endpoints were time to progression, tumor response rate, and adverse events. Inverse probability of treatment weighting (IPTW) using the propensity score was conducted to reduce treatment selection bias.
Results
Among 150 study patients, 102 patients received regorafenib and 48 patients received nivolumab. Median OS was 6.9 (95% confidence interval [CI], 3.0-10.8) months for regorafenib and 5.9 (95% CI, 3.7-8.1) months for nivolumab (P=0.77 by log-rank test). In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04). Time to progression was not significantly different between groups (nivolumab vs. regorafenib: aHR, 0.82; 95% CI, 0.51-1.30; P=0.48). HRs were maintained after IPTW. Objective response rates were 5.9% and 16.7% in patients treated with regorafenib and nivolumab, respectively (P=0.04).
Conclusions
After sorafenib failure, the use of nivolumab may be associated with improved OS and better objective response rate as compared to using regorafenib.",2020,"In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04).","['150 study patients', 'Consecutive HCC patients who received regorafenib or nivolumab after failure of sorafenib treatment were included', 'patients with hepatocellular carcinoma (HCC) failing previous sorafenib treatment', '102 patients received', 'hepatocellular carcinoma patients who failed sorafenib treatment']","['nivolumab versus regorafenib', 'regorafenib', 'nivolumab', 'regorafenib and nivolumab']","['overall survival (OS) and secondary endpoints were time to progression, tumor response rate, and adverse events', 'Median OS', 'Objective response rates', 'Time to progression', 'OS and better objective response rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",150.0,0.318331,"In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04).","[{'ForeName': 'Cheol-Hyung', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yun Bin', 'Initials': 'YB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Minseok Albert', 'Initials': 'MA', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Heejoon', 'Initials': 'H', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyunwoo', 'Initials': 'H', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sun Woong', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}]",Clinical and molecular hepatology,['10.3350/cmh.2019.0049n']
3078,32460725,"A two arm randomized controlled trial comparing the short and long term effects of an elimination diet and a healthy diet in children with ADHD (TRACE study). Rationale, study design and methods.","BACKGROUND
Food may trigger Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. Therefore, an elimination diet (ED) might be an effective treatment for children with ADHD. However, earlier studies were criticized for the nature of the control group, potential confounders explaining the observed effects, unsatisfactory blinding, potential risks of nutritional deficiencies and unknown long term and cost-effectiveness. To address these issues, this paper describes the rationale, study design and methods of an ongoing two arm randomized controlled trial (RCT) comparing the short (5 week) and long term (1 year) effects of an elimination diet and a healthy diet compared with care as usual (CAU) in children with ADHD.
METHODS
A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet. A comparator arm including N = 60 children being solely treated with CAU (e.g. medication) is used to compare the effects found in both dietary groups. The two armed RCT is performed in two youth psychiatry centers in the Netherlands, with randomization within each participating center. The primary outcome measure is response to treatment defined as a ≥ 30% reduction on an ADHD DSM-5 rating scale (SWAN) and/or on an emotion dysregulation rating scale (SDQ: dysregulation profile). This is assessed after 5 weeks of dietary treatment, after which participants continue the diet or not. Secondary outcome measures include the Disruptive Behavior Diagnostic Observational Schedule (DB-DOS), parent and teacher ratings of comorbid symptoms, cognitive assessment (e.g. executive functions), school functioning, physical measurements (e.g. weight), motor activity, sleep pattern, food consumption, nutritional quality of the diet, adherence, parental wellbeing, use of health care resources and cost-effectiveness. Assessments take place at the start of the study (T0), after five weeks (T1), four months (T2), eight months (T3) and 12 months of treatment (T4). T0, T1 and T4 assessments take place at one of the psychiatric centers. T2 and T3 assessments consist of filling out online questionnaires by the parents only.
DISCUSSION
This RCT will likely contribute significantly to clinical practice for ADHD by offering insight into the feasibility, nutritional quality, (cost-)effectiveness and long term effects of dietary treatments for ADHD.
TRIAL REGISTRATION
www.trialregister.nl, NTR5434. Registered at October 11th, 2015.",2020,A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet.,"['children with ADHD', 'children with ADHD (TRACE study', 'two youth psychiatry centers in the Netherlands, with randomization within each participating center', 'A total of N\u2009=\u2009162 children (5-12\u2009years) with ADHD']","['elimination diet and a healthy diet', 'elimination diet and a healthy diet compared with care as usual (CAU', 'CAU (e.g. medication']","['response to treatment defined as a\u2009≥\u200930% reduction on an ADHD DSM-5 rating scale (SWAN) and/or on an emotion dysregulation rating scale (SDQ: dysregulation profile', 'Disruptive Behavior Diagnostic Observational Schedule (DB-DOS), parent and teacher ratings of comorbid symptoms, cognitive assessment (e.g. executive functions), school functioning, physical measurements (e.g. weight), motor activity, sleep pattern, food consumption, nutritional quality of the diet, adherence, parental wellbeing, use of health care resources and cost-effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0452376', 'cui_str': 'Elimination diet'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0521246,A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet.,"[{'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bosch', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands. a.bosch@karakter.com.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Bierens', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Ardine G', 'Initials': 'AG', 'LastName': 'de Wit', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ly', 'Affiliation': 'Leiden University, Institute of Psychology and Leiden Institute for Brain and Cognition, Leiden, The Netherlands.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'van der Velde', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'de Boer', 'Affiliation': 'Accare, Child and Adolescent Psychiatry, Groningen, the Netherlands.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'van Beek', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Appelman', 'Affiliation': 'Triversum - GGZ-NHN, Child and Adolescent Psychiatry, Alkmaar, the Netherlands.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Visser', 'Affiliation': 'Freelance dietician, Velp, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bos', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'van der Meer', 'Affiliation': 'De Bascule, Center for Child and Adolescent Psychiatry, Amsterdam, The Netherlands.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Kamphuis', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Jos M T', 'Initials': 'JMT', 'LastName': 'Draaisma', 'Affiliation': ""Department of Pediatrics, Radboud University Medical Center Amalia Children's hospital, Nijmegen, the Netherlands.""}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Gigi H H', 'Initials': 'GHH', 'LastName': 'van de Loo-Neus', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bottelier', 'Affiliation': 'Triversum - GGZ-NHN, Child and Adolescent Psychiatry, Alkmaar, the Netherlands.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Arias-Vasquez', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Klip', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}, {'ForeName': 'Saskia W', 'Initials': 'SW', 'LastName': 'van den Berg', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.'}, {'ForeName': 'Nanda N', 'Initials': 'NN', 'LastName': 'Rommelse', 'Affiliation': 'Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-02576-2']
3079,32460748,The safe use of dating applications among men who have sex with men: a study protocol for a randomised controlled trial to evaluate an interactive web-based intervention to reduce risky sexual behaviours.,"BACKGROUND
Notably, both international and local studies have found a high prevalence of sexually transmitted infections (STIs) and risky sexual behaviours, such as condomless anal sex, substance misuse in conjunction with sex ('chemsex') and group sex, among men who have sex with men (MSM) dating application (app) users. Although the use of dating apps is an emerging sexual risk factor, little effort has been expended on the promotion of safe sex and good sexual health among the users of those apps. Therefore, the aim of the proposed study is to develop and evaluate the effectiveness of an interactive web-based intervention in improving the sexual health of MSM dating app users in Hong Kong.
METHODS
A two-armed randomised controlled trial will be conducted. Chinese MSM dating app users will be recruited and randomly allocated into either the intervention (n = 200) or control group (n = 200). Subjects in the intervention group will receive the web-based intervention containing interactive content that (1) encourages a positive attitude towards consistent condom use and HIV/STI testing and negative attitude towards chemsex and group sex; (2) positions condom use and regular HIV/STI testing as normative; and (3) targets improved perceived self-efficacy concerning condom use and negotiation and HIV/STI testing. The control group will receive only web-based information without sexual health components. Subjects in both groups will be evaluated at baseline and three and 6 months after baseline. The primary outcome will be the frequency of condomless anal sex in the past 3 months.
DISCUSSION
The proposed study will aid development of culturally relevant health promotion programmes aimed at minimising the potential harm of dating app use and promoting the sexual health of MSM dating app users. The web-based intervention, if found successful, will have important clinical and policy implications, as it can be adopted by the government and non-governmental organisations targeting MSM. Moreover, the proposed intervention can reach many MSM at relatively low cost, and thus has the potential to check the burgeoning HIV/STI epidemic among MSM in Hong Kong in a cost-effective manner.
TRIAL REGISTRATION
International standard randomized controlled trial number (ISRCTN) registry: ISRCTN16681863 registered on 28 April 2020.",2020,The proposed study will aid development of culturally relevant health promotion programmes aimed at minimising the potential harm of dating app use and promoting the sexual health of MSM dating app users.,"['men who have sex with men (MSM) dating application (app) users', 'MSM dating app users in Hong Kong', 'Chinese MSM dating app users', 'men who have sex with men']","['web-based intervention containing interactive content that (1) encourages a positive attitude towards consistent condom use and HIV/STI testing and negative attitude towards chemsex and group sex; (2) positions condom use and regular HIV/STI testing as normative; and (3) targets improved perceived self-efficacy concerning condom use and negotiation and HIV/STI testing', 'control group will receive only web-based information without sexual health components', 'interactive web-based intervention']","['risky sexual behaviours', 'frequency of condomless anal sex in the past 3\u2009months']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0901602,The proposed study will aid development of culturally relevant health promotion programmes aimed at minimising the potential harm of dating app use and promoting the sexual health of MSM dating app users.,"[{'ForeName': 'Edmond P H', 'Initials': 'EPH', 'LastName': 'Choi', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong. h0714919@connect.hku.hk.'}, {'ForeName': 'Eric P F', 'Initials': 'EPF', 'LastName': 'Chow', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Eric Y F', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'William C W', 'Initials': 'WCW', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Janet Y H', 'Initials': 'JYH', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Daniel Y T', 'Initials': 'DYT', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block 21 Sassoon Road, Pokfulam, Hong Kong.'}]",BMC public health,['10.1186/s12889-020-08914-z']
3080,31806881,"OPRM1, OPRK1, and COMT genetic polymorphisms associated with opioid effects on experimental pain: a randomized, double-blind, placebo-controlled study.","Genetic polymorphisms have been shown to affect opioid requirement for pain relief. However, true genetic effect is often difficult to assess due to underlying pain conditions and placebo effects. The goal of this study was to understand how common polymorphisms affect opioid effects while controlling for these factors. A randomized, double-blind, placebo-controlled study was implemented to assess how opioid effects are modulated by COMT (rs6269, rs4633, rs4848, rs4680), OPRM1 (A118G), and OPRK1 (rs1051660, rs702764, rs16918875). One hundred and eight healthy subjects underwent experimental pain testing before and after morphine, butorphanol, and placebo (saline). Association analysis was performed between polymorphisms/haplotypes and opioid response, while correcting for race, gender, placebo effects, and multiple comparisons. Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol. The AA genotype of rs4680 or A_T_C_A/ A_T_C_A (rs6269_rs4633_ rs4818_rs4680) diplotype of COMT, combined with the AG genotype of OPRM1 A118G, showed significantly increased pressure pain threshold from butorphanol. Opioid effects on pressure, ischemic, heat pain, and side effects were nominally associated with several SNPs and haplotypes. Effects were often present in one opioid but not the other. This indicates that these polymorphisms affect pain relief from opioids, and that their effects are opioid and pain modality specific.",2020,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,['One hundred and eight healthy subjects'],"['butorphanol', 'morphine, butorphanol, and placebo (saline', 'placebo']","['Pressure pain', 'pressure, ischemic, heat pain, and side effects', 'pressure pain', 'experimental pain']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",108.0,0.58088,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,"[{'ForeName': 'Kwo Wei David', 'Initials': 'KWD', 'LastName': 'Ho', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, Stanford University, Redwood City, CA, USA. kwoweiho@stanford.edu.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Wallace', 'Affiliation': 'Department of Molecular Genetics & Microbiology, and UF Genetics Institute, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville, FL, USA.'}]",The pharmacogenomics journal,['10.1038/s41397-019-0131-z']
3081,32467805,Management of Gunshot Injuries of Mandible with Open Reduction and Internal Fixation versus Closed Reduction and Maxillo-mandibular Fixation.,"Background/objectives Gunshot injuries are known to cause severe morbidity and mortality when facial regions are involved. Management of the gunshot wounds of the face comprises of securing an airway, controlling hemorrhage, identifying other injuries and definite repair of the traumatic facial deformities. The objective of the present study was to compare the clinical outcome (infection and nonunion) of open reduction and internal fixation versus closed reduction and maxillo-mandibular fixation (CR-MMF) in the treatment of gunshot injuries of the mandible. Materials & methods This study was conducted at Oral and Maxillofacial Surgery Department of Shaheed Zulfiqar Ali Bhutto Medical University/Pakistan Institute of Medical Sciences Islamabad, Pakistan. Ninety gunshot mandibular fractures were randomly allocated in two equal groups. In group-A, 45 patients were treated by open reduction and internal fixation while in group-B, 45 patients were also managed by closed reduction and maxillo-mandibular fixation. Post-operative complications (infection, non-union) were evaluated clinically and radiographically in both groups. Results Patients treated by open reduction and internal fixation were having more complications in terms of infection (17.8%) as compared to closed reduction (4.4%) with a p-value 0.044. Whereas non-union was more in closed reduction (15.6%) as compared to open reduction and internal fixation group (2.2%) with a significant p-value 0.026. Conclusion Both the treatment modalities can be used in the management of gunshot injuries of mandible and there is need for further studies to have clear guideline in this regard in best interest of patients, community and health care providers.",2020,Results Patients treated by open reduction and internal fixation were having more complications in terms of infection (17.8%) as compared to closed reduction (4.4%) with a p-value 0.044.,"['Ninety gunshot mandibular fractures', 'Oral and Maxillofacial Surgery Department of Shaheed Zulfiqar Ali Bhutto Medical University/Pakistan Institute of Medical Sciences Islamabad, Pakistan', 'gunshot injuries of the mandible']","['open reduction and internal fixation versus closed reduction and maxillo-mandibular fixation (CR-MMF', 'Internal Fixation versus Closed Reduction and Maxillo-mandibular Fixation']",['clinical outcome (infection and nonunion'],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0043252', 'cui_str': 'Gunshot wound'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]","[{'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",45.0,0.0151286,Results Patients treated by open reduction and internal fixation were having more complications in terms of infection (17.8%) as compared to closed reduction (4.4%) with a p-value 0.044.,"[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Muddassar', 'Affiliation': 'Oral Medicine / Oral and Maxillofacial Surgery, Islam Dental College, Sialkot, PAK.'}, {'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Arshad', 'Affiliation': 'Oral and Maxillofacial Surgery, Bahria University Medical and Dental College, Karachi, PAK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rabbani', 'Affiliation': 'Oral Pathology, Sharif Medical and Dental College, Lahore, PAK.'}, {'ForeName': 'Imran S', 'Initials': 'IS', 'LastName': 'Qureshi', 'Affiliation': 'Operative Dentistry, Frontier Medical and Dental College, Abbottabad, PAK.'}, {'ForeName': 'Imran K', 'Initials': 'IK', 'LastName': 'Khattak', 'Affiliation': 'Community Dentistry, Frontier Medical and Dental College, Abbottabad, PAK.'}, {'ForeName': 'Zahoor', 'Initials': 'Z', 'LastName': 'Rana', 'Affiliation': 'Oral and Maxillofacial Surgery, Shaheed Zulfiqar Ali Bhutto Medical University/Pakistan Institute of Medical Sciences (PIMS), Islamabad, PAK.'}]",Cureus,['10.7759/cureus.7830']
3082,32467815,Comparison of Ureteroscopic Pneumatic Lithotripsy and Extracorporeal Shock Wave Lithotripsy for Proximal Ureteral Calculi.,"Objective The goal of this study was to compare the effectiveness and complications of ureteroscopic pneumatic lithotripsy (URS) and extracorporeal shock wave lithotripsy (SWL) in the management of patients with proximal ureteral stones. Methods In this trial, 150 patients presenting with proximal ureteral stones at the Department of Urology of Nishter Hospital Multan from November 2018 to November 2019 were allocated 1:1 to undergo URS or SWL. The presence of stone fragments <4 mm on follow-up was regarded as being stone free. The study outcomes included stone-free rates after first, second, and third treatment sessions and stone retropulsion into the kidneys. Results A total of 75 patients each underwent URS and SWL. The mean procedure times for SWL and URS were 61.61± 3.21 and 85.01±6.75 minutes, respectively (P=0.000), and the mean numbers of procedures were 1.51±0.49 and 1.01±0.42, respectively (P=0.000). Stone-free rates after the first, second, and third sessions of SWL were 64%, 77.3%, and 94.7%, respectively, whereas stone-free rates after the first, second, and third sessions of URS were 86.7%, 92%, and 100%, respectively. Rates of stone retropulsion into the kidneys in the SWL and URS groups were 0% and 6.7%, respectively (P=0.000). Conclusion Compared with SWL, URS had significantly higher stone-free rates in patients with proximal ureteral stones. Treatment costs and hospital stay were lower in the SWL group, whereas complication rates were comparable.",2020,"The study outcomes included stone-free rates after first, second, and third treatment sessions and stone retropulsion into the kidneys.","['patients with proximal ureteral stones', '150 patients presenting with proximal ureteral stones at the Department of Urology of Nishter Hospital Multan from November 2018 to November 2019', '75 patients each underwent URS and SWL', 'Proximal Ureteral Calculi']","['SWL, URS', 'URS or SWL', 'Ureteroscopic Pneumatic Lithotripsy and Extracorporeal Shock Wave Lithotripsy', 'ureteroscopic pneumatic lithotripsy (URS) and extracorporeal shock wave lithotripsy (SWL']","['complication rates', 'Treatment costs and hospital stay', 'stone-free rates', 'mean numbers of procedures', 'mean procedure times for SWL and URS', 'stone retropulsion into the kidneys', 'Stone-free rates', 'Rates of stone retropulsion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0277845', 'cui_str': 'Retropulsion'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",150.0,0.0392211,"The study outcomes included stone-free rates after first, second, and third treatment sessions and stone retropulsion into the kidneys.","[{'ForeName': 'Muhammad Fazal', 'Initials': 'MF', 'LastName': 'Ur Rehman', 'Affiliation': 'Urology, Bakhtawar Amin Medical and Dental College, Multan, PAK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Adnan', 'Affiliation': 'Urology, Bakhtawar Amin Medical and Dental College, Multan, PAK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Urology, University of Lahore Teaching Hospital, Lahore, PAK.'}, {'ForeName': 'Fawad', 'Initials': 'F', 'LastName': 'Humayun Akhtar', 'Affiliation': 'Urology, Children Hospital and Institute of Child Health, Lahore, PAK.'}, {'ForeName': 'Naseem', 'Initials': 'N', 'LastName': 'Javed', 'Affiliation': 'Paediatric Urology, Children Hospital and Institute of Child Health, Lahore, PAK.'}, {'ForeName': 'Farman', 'Initials': 'F', 'LastName': 'Ali', 'Affiliation': 'Internal Medicine, District Headquarter Hospital, Khanewal, PAK.'}]",Cureus,['10.7759/cureus.7840']
3083,32467832,Potions for Emotions: Do self-reported individual differences in negative-emotional drinking predict alcohol consumption in the laboratory following exposure to a negative experience?,"Aims
Research suggests that self-reports on inferred motives for engaging in behavior may be biased by limited introspective access into such processes. Self-reports on observable behavior, on the other hand, may generate more accurate responses with which to predict behavior. The aim was to determine whether drinking alcohol in response to negative emotion ( negative-emotional drinking; NED ) is best predicted by self-reported individual differences in ( a ) motives to use alcohol to regulate negative emotion, or ( b ) the degree to which negative emotion impacts alcohol consumption (observable behavior).
Methods
Thirty-nine beer drinkers completed the Drinking Motives Questionnaire-Revised (DMQ-R) which measures individual differences in drinking motives, including the motive to regulate negative emotion (coping motives). They also completed a new self-report measure of the degree to which negative emotion impacts their alcohol consumption. Participants were randomized into a negative emotion induction condition or control condition and completed a subsequent alcohol consumption task to serve as a behavioral measure of drinking in response to negative emotion.
Results
Self-reports on the degree to which negative emotion impacts respondents' alcohol consumption strongly predicted alcohol consumption in the negative emotion induction condition ( r = 0.72, p = <.001) and not in the control condition ( r = 0.09, p = .696). Self-reported coping motives did not predict alcohol consumption in either condition.
Conclusions
The amount of alcohol consumed in response to negative emotion is best predicted by self-reports on observable behavior, and not by self-reports on drinking motives.",2020,"Self-reports on the degree to which negative emotion impacts respondents' alcohol consumption strongly predicted alcohol consumption in the negative emotion induction condition ( r = 0.72, p = <.001) and not in the control condition ( r = 0.09, p = .696).",[],['negative emotion induction condition or control condition and completed a subsequent alcohol consumption task to serve as a behavioral measure of drinking in response to negative emotion'],['Drinking Motives Questionnaire-Revised (DMQ-R'],[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",,0.00916342,"Self-reports on the degree to which negative emotion impacts respondents' alcohol consumption strongly predicted alcohol consumption in the negative emotion induction condition ( r = 0.72, p = <.001) and not in the control condition ( r = 0.09, p = .696).","[{'ForeName': 'Henry R T', 'Initials': 'HRT', 'LastName': 'Austin', 'Affiliation': 'Elizabeth Rutherford Memorial Centre for the Advancement of Research on Emotion (CARE), University of Western Australia, Australia.'}, {'ForeName': 'Lies', 'Initials': 'L', 'LastName': 'Notebaert', 'Affiliation': 'Elizabeth Rutherford Memorial Centre for the Advancement of Research on Emotion (CARE), University of Western Australia, Australia.'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-Lab, Universiteit van Amsterdam, Netherlands.'}, {'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Salemink', 'Affiliation': 'Addiction Development and Psychopathology (ADAPT)-Lab, Universiteit van Amsterdam, Netherlands.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'MacLeod', 'Affiliation': 'Elizabeth Rutherford Memorial Centre for the Advancement of Research on Emotion (CARE), University of Western Australia, Australia.'}]",Addictive behaviors reports,['10.1016/j.abrep.2019.100243']
3084,32469183,Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.,"BACKGROUND
Injectable luteinizing hormone-releasing hormone agonists (e.g., leuprolide) are the standard agents for achieving androgen deprivation for prostate cancer despite the initial testosterone surge and delay in therapeutic effect. The efficacy and safety of relugolix, an oral gonadotropin-releasing hormone antagonist, as compared with those of leuprolide are not known.
METHODS
In this phase 3 trial, we randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks. The primary end point was sustained testosterone suppression to castrate levels (<50 ng per deciliter) through 48 weeks. Secondary end points included noninferiority with respect to the primary end point, castrate levels of testosterone on day 4, and profound castrate levels (<20 ng per deciliter) on day 15. Testosterone recovery was evaluated in a subgroup of patients.
RESULTS
A total of 622 patients received relugolix and 308 received leuprolide. Of men who received relugolix, 96.7% (95% confidence interval [CI], 94.9 to 97.9) maintained castration through 48 weeks, as compared with 88.8% (95% CI, 84.6 to 91.8) of men receiving leuprolide. The difference of 7.9 percentage points (95% CI, 4.1 to 11.8) showed noninferiority and superiority of relugolix (P<0.001 for superiority). All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001). The percentage of patients with castrate levels of testosterone on day 4 was 56.0% with relugolix and 0% with leuprolide. In the subgroup of 184 patients followed for testosterone recovery, the mean testosterone levels 90 days after treatment discontinuation were 288.4 ng per deciliter in the relugolix group and 58.6 ng per deciliter in the leuprolide group. Among all the patients, the incidence of major adverse cardiovascular events was 2.9% in the relugolix group and 6.2% in the leuprolide group (hazard ratio, 0.46; 95% CI, 0.24 to 0.88).
CONCLUSIONS
In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with leuprolide, with a 54% lower risk of major adverse cardiovascular events. (Funded by Myovant Sciences; HERO ClinicalTrials.gov number, NCT03085095.).",2020,All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001).,"['Advanced Prostate Cancer', 'men with advanced prostate cancer', '622 patients received relugolix and 308 received', 'patients with advanced prostate cancer']","['luteinizing hormone-releasing hormone agonists (e.g., leuprolide', 'Oral Relugolix', 'leuprolide', 'relugolix']","['castrate levels of testosterone on day 4, and profound castrate levels', 'Testosterone recovery', 'sustained testosterone suppression to castrate levels', 'mean testosterone levels', 'incidence of major adverse cardiovascular events', 'castrate levels of testosterone', 'superiority of relugolix over leuprolide', 'noninferiority and superiority of relugolix']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}]",622.0,0.384751,All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001).,"[{'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Cookson', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Saltzstein', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Tutrone', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Akaza', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bossi', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'van Veenhuyzen', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Selby', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Kang', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Walling', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004325']
3085,32478802,Comparative Effectiveness of Carotid Endarterectomy vs Initial Medical Therapy in Patients With Asymptomatic Carotid Stenosis.,"Importance
Carotid endarterectomy (CEA) among asymptomatic patients involves a trade-off between a higher short-term perioperative risk in exchange for a lower long-term risk of stroke. The clinical benefit observed in randomized clinical trials (RCTs) may not extend to real-world practice.
Objective
To examine whether early intervention (CEA) was superior to initial medical therapy in real-world practice in preventing fatal and nonfatal strokes among patients with asymptomatic carotid stenosis.
Design, Setting, and Participants
This comparative effectiveness study was conducted from August 28, 2018, to March 2, 2020, using the Corporate Data Warehouse, Suicide Data Repository, and other databases of the US Department of Veterans Affairs. Data analyzed were those of veterans of the US Armed Forces aged 65 years or older who received carotid imaging between January 1, 2005, and December 31, 2009. Patients without a carotid imaging report, those with carotid stenosis of less than 50% or hemodynamically insignificant stenosis, and those with a history of stroke or transient ischemic attack in the 6 months before index imaging were excluded. A cohort of patients who received initial medical therapy and a cohort of similar patients who received CEA were constructed and followed up for 5 years. The target trial method was used to compute weighted Kaplan-Meier curves and estimate the risk of fatal and nonfatal strokes in each cohort in the pragmatic sample across 5 years of follow-up. This analysis was repeated after restricting the sample to patients who met RCT inclusion criteria. Cumulative incidence functions for fatal and nonfatal strokes were estimated, accounting for nonstroke deaths as competing risks in both the pragmatic and RCT-like samples.
Exposures
Receipt of CEA vs initial medical therapy.
Main Outcomes and Measures
Fatal and nonfatal strokes.
Results
Of the total 5221 patients, 2712 (51.9%; mean [SD] age, 73.6 [6.0] years; 2678 men [98.8%]) received CEA and 2509 (48.1%; mean [SD] age, 73.6 [6.0] years; 2479 men [98.8%]) received initial medical therapy within 1 year after the index carotid imaging. The observed rate of stroke or death (perioperative complications) within 30 days in the CEA cohort was 2.5% (95% CI, 2.0%-3.1%). The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%). In an analysis that incorporated the competing risk of death, the risk difference between the 2 cohorts was lower and not statistically significant (risk difference, -0.8%; 95% CI, -2.1% to 0.5%). Among patients who met RCT inclusion criteria, the 5-year risk of fatal and nonfatal strokes was 5.5% (95% CI, 4.5%-6.5%) among patients randomized to CEA and was 7.6% (95% CI, 5.7%-9.5%) among those randomized to initial medical therapy (risk difference, -2.1%; 95% CI, -4.4% to -0.2%). Accounting for competing risks resulted in a risk difference of -0.9% (95% CI, -2.9% to 0.7%) that was not statistically significant.
Conclusions and Relevance
This study found that the absolute reduction in the risk of fatal and nonfatal strokes associated with early CEA was less than half the risk difference in trials from 20 years ago and was no longer statistically significant when the competing risk of nonstroke deaths was accounted for in the analysis. Given the nonnegligible perioperative 30-day risks and the improvements in stroke prevention, medical therapy may be an acceptable therapeutic strategy.",2020,"The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%).","['asymptomatic patients', 'Patients With Asymptomatic Carotid Stenosis', 'total 5221 patients, 2712 (51.9%; mean [SD] age, 73.6 [6.0] years; 2678 men [98.8%]) received CEA and 2509 (48.1%; mean [SD] age, 73.6 [6.0] years; 2479 men [98.8%]) received', 'August 28, 2018, to March 2, 2020, using the Corporate Data Warehouse, Suicide Data Repository, and other databases of the US Department of Veterans Affairs', 'veterans of the US Armed Forces aged 65 years or older who received carotid imaging between January 1, 2005, and December 31, 2009', 'patients with asymptomatic carotid stenosis']","['CEA', 'initial medical therapy', 'Carotid endarterectomy (CEA', 'CEA vs initial medical therapy', 'Carotid Endarterectomy vs Initial Medical Therapy', 'early intervention (CEA']","['rate of stroke or death (perioperative complications', 'history of stroke or transient ischemic attack', 'nonstroke deaths', 'risk of fatal and nonfatal strokes', 'fatal and nonfatal strokes', '5-year risk of fatal and nonfatal strokes', 'Cumulative incidence functions for fatal and nonfatal strokes', 'Measures\n\n\nFatal and nonfatal strokes']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4505078', 'cui_str': 'Data Warehouse'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0203382', 'cui_str': 'Imaging of carotid arteries'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",5221.0,0.184697,"The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, -2.3%; 95% CI, -4.0% to -0.3%).","[{'ForeName': 'Salomeh', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, UCLA (University of California Los Angeles), Los Angeles.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Hoggatt', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Austin', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Madden', 'Affiliation': 'Northern California Institute of Research and Education, San Francisco.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hebert', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Naseri', 'Affiliation': 'San Francisco Veterans Affairs (VA) Medical Center, San Francisco, California.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Johanning', 'Affiliation': 'Department of Surgery, University of Nebraska, Omaha.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mowery', 'Affiliation': 'Biomedical Informatics, University of Utah, Salt Lake City.'}, {'ForeName': 'Wendy W', 'Initials': 'WW', 'LastName': 'Chapman', 'Affiliation': 'University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1427']
3086,32478849,Effects of In-Person Navigation to Address Family Social Needs on Child Health Care Utilization: A Randomized Clinical Trial.,"Importance
While many organizations endorse screening for social risk factors in clinical settings, few studies have examined the health and utilization effects of interventions to address social needs.
Objective
To compare the acute care utilization effects of a written resources handout vs an in-person navigation service intervention to address social needs.
Design, Settings, and Participants
In this secondary analysis of a randomized clinical trial, 1809 adult caregivers of pediatric patients seen in primary and urgent care clinics of 2 safety-net hospitals in northern California were recruited between October 13, 2013, and August 27, 2015. Each participating family was randomly assigned to an in-person navigator intervention vs active control to address the family's social needs. Analyses were conducted between February 28, 2018, and September 25, 2019.
Interventions
Caregivers either received written information about relevant local resources related to social needs (active control) or met with a patient navigator focused on helping them resolve social needs (navigator intervention). After an initial in-person visit, navigation services included telephone, email, and/or in-person follow-up for up to 3 months.
Main Outcome and Measures
Child emergency department visit or hospitalization within 12 months of study enrollment.
Results
Among the 1300 caregivers enrolled in the study without missing follow-up data, most spoke English (878 [67.5%]) and were women (1127 [86.7%]), with a mean (SD) age of 33.0 (9.33) years. Most children were aged 0 to 5 years (779 of 1300 [59.9%]), 723 children (55.6%) had Hispanic ethnicity, and 462 children (35.5%) were in excellent health; 840 families (64.6%) were recruited from urgent care. In total, 637 families (49.0%) were randomized to the in-person navigator group and 663 (51.0%) to the active control group. There was no difference in risk of an emergency department visit between the 2 groups. Children enrolled in the in-person navigator group had a decreased risk of hospitalization within 12 months (hazard ratio, 0.59; 05% CI, 0.38-0.94; P = .03), making them 69% less likely to be hospitalized.
Conclusions and Relevance
In this randomized clinical trial evaluating heath care utilization effects of programs designed to address social needs among families, children enrolled in the navigation group were significantly less likely to be hospitalized after the intervention but equally likely to have an emergency department visit. These findings strengthen our understanding of the effects of addressing social needs in clinical settings as part of a comprehensive strategy to improve health and reduce health care utilization.
Trial Registration
ClinicalTrials.gov Identifier: NCT01939704.",2020,"Children enrolled in the in-person navigator group had a decreased risk of hospitalization within 12 months (hazard ratio, 0.59; 05% CI, 0.38-0.94; P = .03), making them 69% less likely to be hospitalized.
","['1300 caregivers enrolled in the study without missing follow-up data, most spoke English (878 [67.5%]) and were women (1127 [86.7%]), with a mean (SD) age of 33.0 (9.33) years', 'In total, 637 families (49.0', '1809 adult caregivers of pediatric patients seen in primary and urgent care clinics of 2 safety-net hospitals in northern California were recruited between October 13, 2013, and August 27, 2015', 'Most children were aged 0 to 5 years (779 of 1300 [59.9%]), 723 children (55.6%) had Hispanic ethnicity, and 462 children (35.5%) were in excellent health; 840 families (64.6%) were recruited from urgent care', 'Child Health Care Utilization']","['written information about relevant local resources related to social needs (active control) or met with a patient navigator focused on helping them resolve social needs (navigator intervention', 'written resources handout vs an in-person navigation service intervention', ""person navigator intervention vs active control to address the family's social needs"", 'Person Navigation']","['Measures\n\n\nChild emergency department visit or hospitalization within 12 months of study enrollment', 'risk of an emergency department visit', 'risk of hospitalization']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1551285', 'cui_str': 'Urgent care clinic'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517866', 'cui_str': '723'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1809.0,0.114442,"Children enrolled in the in-person navigator group had a decreased risk of hospitalization within 12 months (hazard ratio, 0.59; 05% CI, 0.38-0.94; P = .03), making them 69% less likely to be hospitalized.
","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Pantell', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Dayna', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': ""Center for Child and Community Health, UCSF Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Maoya', 'Initials': 'M', 'LastName': 'Alqassari', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schudel', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, California.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Laves', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Denisse E', 'Initials': 'DE', 'LastName': 'Velazquez', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Anais', 'Initials': 'A', 'LastName': 'Amaya', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sweeney', 'Affiliation': 'School of Nursing, University of California, San Francisco.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': ""Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Francis L', 'Initials': 'FL', 'LastName': 'Harrison', 'Affiliation': 'School of Medicine, University of California, San Francisco.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Adler', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Gottlieb', 'Affiliation': 'Center for Health and Community, University of California, San Francisco.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6445']
3087,32478863,A pilot randomised placebo-controlled trial of cannabidiol to reduce severe behavioural problems in children and adolescents with intellectual disability.,"INTRODUCTION
Severe Behavioural Problems (SBP) are a major contributor to morbidity in children with Intellectual Disability (ID). Medications used to treat SBP in ID are associated with a high risk of side effects. Cannabidiol has potential therapeutic effects in SBP. This pilot study aimed to investigate the feasibility of conducting a randomized placebo-controlled trial of cannabidiol to reduce SBP in children with ID.
METHODS
Double-blind, placebo-controlled, two-armed, parallel-design, randomised controlled trial of cannabidiol in children aged 8 - 16 years with ID and SBP. Participants were randomized 1:1 to receive either 98% cannabidiol in oil (Tilray, Canada) or placebo orally for 8 weeks. The dose was up-titrated over 9 days to 20mg/kg/day in two divided doses, with a maximum dose of 500mg twice/day. The feasibility and acceptability of all study components were assessed.
RESULTS
Eight children were randomised, and all completed the full study protocol. There were no Serious Adverse Events or drop-outs. Protocol adherence for key study components was excellent: study visits 100%, medication adherence 100%, blood tests 92%, and questionnaire completion 88%. Parents reported a high degree of acceptability with the study design. All parents reported they would recommend the study to other families with children with similar problems. There was an efficacy signal in favour of active drug.
CONCLUSIONS
The findings suggest that the study protocol is feasible and acceptable to patients with ID and SBP and their families.",2020,There were no Serious Adverse Events or drop-outs.,"['children and adolescents with intellectual disability', 'children aged 8 - 16 years with ID and SBP', 'children with ID', 'children with Intellectual Disability (ID', 'Eight children']","['cannabidiol', '98% cannabidiol in oil (Tilray, Canada) or placebo', 'placebo']",['severe behavioural problems'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",8.0,0.496793,There were no Serious Adverse Events or drop-outs.,"[{'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Efron', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria.""}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Freeman', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria.""}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Cranswick', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria.""}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Payne', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria.""}, {'ForeName': 'Chidambaram', 'Initials': 'C', 'LastName': 'Prakash', 'Affiliation': ""Royal Children's Hospital, Parkville, Victoria.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria.""}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria.""}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Monash University, Clayton, Victoria.'}]",British journal of clinical pharmacology,['10.1111/bcp.14399']
3088,32478879,Pigmentation effects of blue light irradiation on skin and how to protect against them.,"BACKGROUND
Visible light, in particular blue light, has been identified as an additional contributor to cutaneous photo-aging. However, clinical studies demonstrating the clear effect of blue light on photo-aging are still scarce and so far, most studies have focused on broad spectrum visible light. While there is evidence for increased skin pigmentation, the underlying mechanisms of photo-aging in vivo are still unclear. Furthermore, there is still a need for active ingredients to significantly protect against blue light induced hyperpigmentation in vivo. Our study had two aims: to detect visible changes in skin pigmentation following repeated irradiation of the skin with LED-based blue light; and to reduce pigmentation using suitable active ingredients.
METHOD
We conducted a randomized, double-blind and placebo controlled clinical study on 33 female volunteers with skin phototypes III and IV. We used a repetitive blue light (4x 60 J cm -2 , 450 nm) irradiation protocol on the volunteers' inner forearms. Using hyperspectral imaging we assessed chromophore status. In addition, we took chromameter measurements and photographs to assess visible hyperpigmentation.
RESULTS
We measured significant changes in chromophore status (p<0.001 vs baseline), i.e. of melanin, hemoglobin and oxygen saturation, immediately after blue light irradiation. In addition, we found visible skin color changes which were expressed by a significant decrease in ITA° values (delta ITA° = -16.89, p<0.001 vs baseline for the placebo group), and an increase in a* (delta a* = +3.37, p<0.001 vs baseline for the placebo group) 24 hours post irradiation. Hyperpigmentation and skin reddening were mitigated by both a formulation containing 3% of a microalgal product and a formulation containing 3% niacinamide.
CONCLUSION
Our study sets out an efficient and robust protocol for investigating both blue light induced cutaneous alterations, such as changes in skin chromophores, and signs of photoaging, such as hyperpigmentation. Moreover, we have shown evidence that both an extract of the microalga Scenedesmus rubescens and niacinamide (Vitamin B3) have the potential to protect against blue light induced hyperpigmentation.",2020,"Hyperpigmentation and skin reddening were mitigated by both a formulation containing 3% of a microalgal product and a formulation containing 3% niacinamide.
",['33 female volunteers with skin phototypes III and IV'],"['placebo', 'repeated irradiation of the skin with LED-based blue light', 'repetitive blue light (4x 60 J cm -2 , 450 nm) irradiation protocol', 'blue light irradiation']","['ITA° values (delta ITA° ', 'skin pigmentation', 'chromophore status', 'Hyperpigmentation and skin reddening', 'melanin, hemoglobin and oxygen saturation', 'visible skin color changes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",33.0,0.0481121,"Hyperpigmentation and skin reddening were mitigated by both a formulation containing 3% of a microalgal product and a formulation containing 3% niacinamide.
","[{'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Campiche', 'Affiliation': 'DSM Nutritional Products, Personal Care & Aroma, Wurmisweg 576, 4303, Kaiseraugst, Switzerland.'}, {'ForeName': 'Seerooven Jessen', 'Initials': 'SJ', 'LastName': 'Curpen', 'Affiliation': 'Centre International de Développement Pharmaceutique (CIDP), BioPark Mauritius, SOCOTA Phoenicia, Sayed Hossen Road, Phoenix, 73408, Mauritius.'}, {'ForeName': 'Vimi', 'Initials': 'V', 'LastName': 'Lutchmanen-Kolanthan', 'Affiliation': 'Centre International de Développement Pharmaceutique (CIDP), BioPark Mauritius, SOCOTA Phoenicia, Sayed Hossen Road, Phoenix, 73408, Mauritius.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gougeon', 'Affiliation': 'Newtone Technologies, 13 bis Place Jules Ferry, 69006, Lyon, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Cherel', 'Affiliation': 'Newtone Technologies, 13 bis Place Jules Ferry, 69006, Lyon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Laurent', 'Affiliation': 'DSM Nutritional Products, Personal Care & Aroma, Wurmisweg 576, 4303, Kaiseraugst, Switzerland.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Gempeler', 'Affiliation': 'DSM Nutritional Products, Personal Care & Aroma, Wurmisweg 576, 4303, Kaiseraugst, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Schuetz', 'Affiliation': 'DSM Nutritional Products, Personal Care & Aroma, Wurmisweg 576, 4303, Kaiseraugst, Switzerland.'}]",International journal of cosmetic science,['10.1111/ics.12637']
3089,32478913,"Cognitive and physical performance are well preserved following standard blood donation: A noninferiority, randomized clinical trial.","BACKGROUND
A walking blood bank (WBB) refers to the use of fellow combatants for battlefield blood donation. This requires pretesting combatants for infectious diseases and blood type. A fundamental prerequisite for this technique is that the donating soldier will suffer minimal physiological and mental impact. The purpose of the current study is to assess the effect of blood shedding on battlefield performance.
METHODS
This is a double-blind randomized control trial. Forty Israel Defense Forces combatants volunteered for the study. Participants underwent baseline evaluation, including repeated measurement of vital signs, cognitive evaluation, physical evaluation, and a strenuous shooting test. Three weeks after the baseline evaluation, subjects were randomized to either blood donation or the control group. For blinding purposes, all subjects underwent venous catheterization for the duration of a blood donation. Repeated vital signs and function evaluation were then performed.
RESULTS
Thirty-six patients were available for randomization. Baseline measurements were similar for both groups. Mean strenuous shooting score was 80.5 ± 9.5 for the control group and 82 ± 6.6 for the test group (p = 0.58). No clinically or statistically significant differences were found in tests designed to evaluate cognitive performance or physical functions. Vital signs taken multiple times were also similar between the test and control groups.
CONCLUSIONS
Executive, cognitive, and physical functions were well preserved after blood donation. This study supports the hypothesis that a WBB does not decrease donor combat performance. The categorical prohibition of physical exercise following blood donation might need to be reconsidered in both military and civilian populations.",2020,No clinically or statistically significant differences were found in tests designed to evaluate cognitive performance or physical functions.,"['Forty Israel Defense Forces combatants volunteered for the study', 'Thirty-six patients were available for randomization']",[],"['Vital signs taken multiple times', 'Executive, cognitive, and physical functions', 'Cognitive and physical performance', 'Mean strenuous shooting score', 'cognitive performance or physical functions']","[{'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],"[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444774', 'cui_str': 'Shooting sensation quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0682259,No clinically or statistically significant differences were found in tests designed to evaluate cognitive performance or physical functions.,"[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Nadler', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Avishai M', 'Initials': 'AM', 'LastName': 'Tsur', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Ari M', 'Initials': 'AM', 'LastName': 'Lipsky', 'Affiliation': 'Department of Emergency Medicine, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Gadi', 'Initials': 'G', 'LastName': 'Lending', 'Affiliation': 'Bar-Ilan University Faculty of Medicine (G.E.), Safed, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Benov', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Ishai', 'Initials': 'I', 'LastName': 'Ostffeld', 'Affiliation': 'Office of Medical Affairs, National Insurance Institute of Israel, Jerusalem, Israel.'}, {'ForeName': 'Eilat', 'Initials': 'E', 'LastName': 'Shinar', 'Affiliation': 'National Blood Services, Magen David Adom, Ramat Gan, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Yanovich', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Asher', 'Initials': 'A', 'LastName': 'Moser', 'Affiliation': 'National Blood Services, Magen David Adom, Ramat Gan, Israel.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Haiman', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Hakon', 'Initials': 'H', 'LastName': 'Eliassen', 'Affiliation': 'Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Tarif', 'Initials': 'T', 'LastName': 'Bader', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Elon', 'Initials': 'E', 'LastName': 'Glassberg', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Surgeon General's Headquarters, Israel Defense Forces, Ramat Gan, Israel.""}]",Transfusion,['10.1111/trf.15624']
3090,32473865,A prospective randomized controlled clinical investigation comparing two post-operative wound dressings used after elective hip and knee replacement; Mepilex® Border Post-Op versus Aquacel® surgical.,"BACKGROUND
Post-operative wound complications, including blistering and surgical site infections, can increase recovery times, costs associated with hospital stay and morbidity.
AIM
To compare two post-operative wound dressings (Mepilex Border Post-Op and Aquacel Surgical), in patients undergoing elective hip or knee arthroplasty.
METHODS
International, open-label, prospective, superiority, multicentre, randomised, parallel-group, controlled trial. Primary outcome was dressing failure, a composite endpoint assessing four factors weighted from highest to lowest in relation to the risk of surgical site infection.
RESULTS
Mepilex Border Post-Op was comparable or superior to Aquacel® Surgical in all parameters investigated. Dressing failure rates, skin redness, itching under the dressing, pain during dressing removal and number of patients requiring a dressing change were low in both groups. Mepilex® Border Post-Op outperformed Aquacel Surgical for ease of application (p<0.0001) and removal (p<0.0001), ability to handle blood (p<0.0001), prevention of dressing residuals (p=0.0167), patient satisfaction of wearing the dressing during rehabilitation training (p=0.0037) and patients' overall experience with the dressing (P=0.0025).
CONCLUSION
Both dressings performed well in terms of minimizing post-operative wound complications. However, in relation to clinician satisfaction, minimization of pain and facilitation of patient comfort, Mepilex® Border Post-Op outperformed Aquacel Surgical.",2020,"Mepilex® Border Post-Op outperformed Aquacel Surgical for ease of application (p<0.0001) and removal (p<0.0001), ability to handle blood (p<0.0001), prevention of dressing residuals (p=0.0167), patient satisfaction of wearing the dressing during rehabilitation training (p=0.0037) and patients' overall experience with the dressing (P=0.0025).
",['patients undergoing elective hip or knee arthroplasty'],"['elective hip and knee replacement; Mepilex® Border Post-Op versus Aquacel® surgical', 'operative wound dressings (Mepilex Border Post-Op and Aquacel Surgical']","['risk of surgical site infection', 'dressing failure', 'Dressing failure rates, skin redness, itching under the dressing, pain during dressing removal and number of patients requiring a dressing change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0967370', 'cui_str': 'Aquacel'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0663202,"Mepilex® Border Post-Op outperformed Aquacel Surgical for ease of application (p<0.0001) and removal (p<0.0001), ability to handle blood (p<0.0001), prevention of dressing residuals (p=0.0167), patient satisfaction of wearing the dressing during rehabilitation training (p=0.0037) and patients' overall experience with the dressing (P=0.0025).
","[{'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Beele', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van Overschelde', 'Affiliation': 'AZ Maria Middelares, Ghent, Belgium.'}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Olivecrona', 'Affiliation': 'Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Smet', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium. Electronic address: Steven.Smet@uzgent.be.'}]",International journal of orthopaedic and trauma nursing,['10.1016/j.ijotn.2020.100772']
3091,32460116,The marathon of labour-Does regular exercise training influence course of labour and mode of delivery?: Secondary analysis from a randomized controlled trial.,"OBJECTIVES
Today all pregnant women are recommended to participate in moderate intensity aerobic and resistance-based physical activity/exercise ≥150 min/week. However, there are still controversies and scant knowledge on the role of regular exercise on delivery outcomes, including mode of delivery and length of active labour. In addition, nutritional counselling have often been examined together with exercise, which may independently effect the outcomes. Hence, the aims of the present study were to investigate the sole effect of supervised group exercise, including pelvic floor muscle training on course of labour and mode of delivery.
STUDY DESIGN
A single blind, randomized controlled trial, performed in the municipality of Oslo, Norway. Out of 105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7 ± 4.2) to study the effect regular aerobic exercise (60 min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7 ± 1.7) on labour outcomes (exercise: 43 and control: 47). Data were collected via standardized interviews and birth partographs from hospital records, reported on the postpartum visit (weeks after labour 7.6 ± 1.6). The primary investigator was unaware of the original randomization at the time of the interviews. The principal analysis was done on an intention to treat basis (ITT). For the planned subgroup analyses (per protocol), acceptable intervention adherence was defined as attending ≥ 80% of the recommended exercise program (≥ 19 exercise sessions).
RESULTS
There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT. Per protocol analyses, showed a shorter duration of total active labour in the exercise group (6.8 ± 5.5 h) than the control group (9.8 ± 5.4 h), with a mean between group difference of 3.1 h (95% CI 0.31-5.9, p = 0.029). Rate of normal vaginal delivery was 85.7% among adherent participants and 62.3% in the control group (p = 0.051).
CONCLUSIONS
Regular exercise during pregnancy decreased duration of total active labour and showed a trend towards more normal vaginal deliveries among participants who adhered to the prescribed program.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT00617149.",2020,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","['60\u2009min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7\u2009±\u20091.7) on labour outcomes (exercise: 43 and control: 47', 'Today all pregnant women', '105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7\u2009±\u20094.2) to study the effect', 'municipality of Oslo, Norway']","['regular exercise training', 'Regular exercise', 'regular aerobic exercise', 'supervised group exercise, including pelvic floor muscle training']","['normal vaginal deliveries', 'duration of total active labour', 'shorter duration of total active labour', 'Rate of normal vaginal delivery', 'induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT', 'acceptable intervention adherence']","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",105.0,0.114603,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","[{'ForeName': 'Lene A H', 'Initials': 'LAH', 'LastName': 'Haakstad', 'Affiliation': 'Associate Professor, Exercise Scientist, Norwegian School of Sports Sciences, Department of Sports Medicine, PO Box 4014, Ullevål Stadion, Oslo, Norway. Electronic address: lahaakstad@nih.no.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Bø', 'Affiliation': 'Professor, Exercise Scientist, Physical Therapist, Norwegian School of Sports Sciences, Department of Sports Medicine, Norway. Electronic address: kari.bo@nih.no.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.014']
3092,32460138,Social timing influences sleep quality in patients with sleep disorders.,"OBJECTIVES
We aimed to compare three variants of the Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ) and to assess whether chronotype (MSF sc )/social jetlag (SJL) are associated with sleep quality in patients with sleep disorders (SD).
METHODS
In sum, 431 SD patients and 338 subjects from the general population (GP) were included. Participants filled in three variants of the PSQI and the Munich ChronoType Questionnaire (MCTQ). We used Generalized Estimating Equations (GEE) to investigate effects of group (GP, SD), PSQI (usual, work or free) and their interaction (group∗PSQI) on scores. To investigate associations between MSF sc /SJL and the difference between PSQI w and PSQI f (PSQI diff ) in patients with SD we used linear regressions (N = 352). We used Sobel to test whether there was a mediation effect of SJL on the association between MSF sc and PSQI diff .
RESULTS
PSQI scores differed between groups (p < 0.001). Post-hoc analysis revealed a significant difference between PSQI u vs. PSQI f and PSQI w vs. PSQI f with PSQI f presenting lower scores, while PSQI u vs. PSQI w did not differ in any group. In line with previous findings, SJL was associated to PSQI diff in SD patients.
CONCLUSIONS
PSQI u mainly represents sleep quality on workdays also in SD patients. Being a late chronotype seems to be associated with higher differences in sleep quality on work-vs. free days mostly when it coincides with societal time constraints. Since sleep quality is poorer on workdays even in SD patients, we suggest that treatment strategies should address social aspects affecting sleep, including ways of minimizing SJL.",2020,"f presenting lower scores, while PSQI u vs. PSQI w did not differ in any group.","['patients with sleep disorders (SD', 'patients with SD', 'patients with sleep disorders', '431 SD patients and 338 subjects from the general population (GP) were included', 'SD patients']","['chronotype (MSF sc )/social jetlag (SJL', 'MSF sc /SJL', 'PSQI', 'SJL']","['PSQI (usual, work or free) and their interaction (group∗PSQI) on scores', 'PSQI u vs. PSQI f and PSQI w vs. PSQI', 'Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ', 'PSQI scores', 'Munich ChronoType Questionnaire (MCTQ', 'sleep quality', 'PSQI w and PSQI f (PSQI diff ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0231311', 'cui_str': 'Jet lag'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0284205,"f presenting lower scores, while PSQI u vs. PSQI w did not differ in any group.","[{'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Reis', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; IMM - Faculty of Medicine João Lobo Antunes, University of Lisbon, Portugal.'}, {'ForeName': 'Luísa K', 'Initials': 'LK', 'LastName': 'Pilz', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Laboratório de Cronobiologia e Sono, HCPA/UFRGS, Porto Alegre, RS, Brazil; PPG em Psiquiatria e Ciências do Comportamento, UFRGS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Lena Katharina', 'Initials': 'LK', 'LastName': 'Keller', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Department of Child and Adolescent Psychiatry, University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Paiva', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; CHRC - Nova Medical School - Faculdade de Ciências Médicas, Lisbon, Portugal.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Roenneberg', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany. Electronic address: roenneberg@lmu.de.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.019']
3093,32460145,Effect of cognitive rehabilitation on neuropsychological and semiecological testing and on daily cognitive functioning in multiple sclerosis: The REACTIV randomized controlled study.,"BACKGROUND
Specific cognitive rehabilitation (SCR) has been suggested for multiple sclerosis (MS). A randomized controlled trial (RCT) evaluating the therapeutic effects of SCR is necessary.
OBJECTIVE
To demonstrate the superiority of a SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning.
METHODS
A single-blind RCT compared SCR and NSI in patients with MS with cognitive complaint. Both programs included 50 individual sessions, 3 times a week for 17 weeks in a real-world setting. The primary end-point was NP assessment. Secondary end-points included semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment. Maintenance of the effects at 8 months was studied.
RESULTS
Of the 35 patients, 18 completed the SCR, and 17 completed the NSI. Several NP and semiecological scores improved significantly more after SCR than after NSI. More NP scores improved significantly after SCR than after NSI. SCR improved daily cognitive functioning. Most improvements were maintained at 8 months.
CONCLUSION
SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.",2020,"CONCLUSION
SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","['35 patients', 'patients with MS with cognitive complaint', 'multiple sclerosis']","['Specific cognitive rehabilitation (SCR', 'cognitive rehabilitation', 'SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning']","['SCR improved daily cognitive functioning', 'semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment', 'NP scores', 'Several NP and semiecological scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.067952,"CONCLUSION
SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lamargue', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Koubiyr', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saubusse', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Charre-Morin', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moroso', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Coupé', 'Affiliation': 'Laboratoire Bordelais de Recherche en Informatique, UMR CNRS 5800, PICTURA, F-33405 Talence, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France. Electronic address: bruno.brochet@chu-bordeaux.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116929']
3094,32460523,"A Randomized, Double-Blind, Placebo-Controlled Trial of Vilazodone in Children and Adolescents with Major Depressive Disorder with Twenty-Six-Week Open-Label Follow-Up.","Objective: To evaluate the efficacy and long-term safety of vilazodone in children and adolescent outpatients with major depressive disorder (MDD). Methods: Children and adolescents aged 7-17 years of age with MDD were randomized 2:2:1 to 8 weeks of double-blind placebo, vilazodone 15 or 30 mg/day or fluoxetine 20 mg/day, respectively. The primary and secondary efficacy outcomes, respectively, were change from baseline to week 8 in Children's Depression Rating Scale-Revised (CDRS-R) score total score and Clinical Global Impressions-Severity (CGI-S) score analyzed using a mixed model for repeated measurement approach. Patients who completed the 8-week randomized controlled trial (RCT), as well as new ( de novo ) patients, could participate in a 26-week, vilazodone-only, open-label extension (OLE) study. Results: The RCT enrolled 473 patients (60% female) with an average age of 13 years. Change in CDRS-R and CGI-S scores from baseline to week 8 did not differ between patients who received vilazodone and those randomized to placebo. The least-squares mean change from baseline in CDRS-R scores was similar for vilazodone and placebo (-20.7 vs. -20.3, p = 0.77; least-squares mean difference [LSMD] = -0.40). For fluoxetine, the LSMD versus placebo was -2.3 ( p = 0.14). The OLE enrolled 330 patients (60% female) with an average age of 13-14 years. Overall, no new safety concerns were identified compared to what is known in adults. Conclusions: Similar improvements in depressive symptoms were observed in all arms. This study does not support the efficacy of vilazodone 15 or 30 mg/day for pediatric patients with MDD. No new or unexpected safety concerns were detected during the RCT or OLE studies.",2020,"The least-squares mean change from baseline in CDRS-R scores was similar for vilazodone and placebo (-20.7 vs. -20.3, p = 0.77; least-squares mean difference [LSMD] = -0.40).","['pediatric patients with MDD', 'enrolled 330 patients (60% female) with an average age of 13-14 years', 'Children and adolescents aged 7-17 years of age with MDD', 'enrolled 473 patients (60% female) with an average age of 13 years', 'Children and Adolescents with Major Depressive Disorder with Twenty-Six-Week Open-Label Follow-Up', 'children and adolescent outpatients with major depressive disorder (MDD']","['Vilazodone', 'Placebo', 'OLE', 'RCT', 'placebo', 'fluoxetine', 'placebo, vilazodone 15 or 30\u2009mg/day or fluoxetine', 'vilazodone-only, open-label extension (OLE) study', 'vilazodone']","['Change in CDRS-R and CGI-S scores', ""Children's Depression Rating Scale-Revised (CDRS-R) score total score and Clinical Global Impressions-Severity (CGI-S) score"", 'CDRS-R scores', 'depressive symptoms']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C1530072', 'cui_str': 'vilazodone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",473.0,0.134338,"The least-squares mean change from baseline in CDRS-R scores was similar for vilazodone and placebo (-20.7 vs. -20.3, p = 0.77; least-squares mean difference [LSMD] = -0.40).","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'McCusker', 'Affiliation': 'CNS, AbbVie, Irvine, California, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Anxiety Disorders Research Program, University of Cincinnati, Cincinnati, Ohio, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0176']
3095,32460712,Efficacy of a single dose versus a multiple dose regimen of Mebendazole against hookworm infections among school children: a randomized open-label trial.,"BACKGROUND
Despite the existence of a population-based control program using single dose albendazole or mebendazole as a preventive chemotherapy, hookworm transmission remains high. It causes a negative impact on the growth and school performance of children. In connection to this preventive chemotherapy, different studies produced conflicting results. This study aimed at evaluating the efficacy of single (500 mg) versus multiple doses (100 mg twice a day during three consecutive days) of mebendazole against hookworm infections among school-aged children.
METHODS
This randomized open-label clinical trial took place among school-aged children (6-14 years old) in Burie and Debre Elias towns, Northwest Ethiopia. Using simple randomization, eligible hookworm-positive children were allocated (1:1) to either a single or multiple dose treatment arms. Stool samples were collected and processed using McMaster method at baseline and follow-up period (14-21 days after treatment). Only laboratory technicians were blinded. The cure and egg reduction rates were the primary and secondary therapeutic outcome measures against hookworm infections, respectively. An independent t-test was used to compare group means, and logistic regression was used to calculate odds ratio (OR). P-value < 0.05 at 95% CI was considered statistically significant.
RESULT
One hundred eight children, 54 in each treatment arm had completed baseline data and received allocated treatment. One hundred three children had completed follow-up data records and included for the final efficacy analysis. Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR = 55.125; 95% CI: 11.92-254.9; P < 0.001. The egg reduction rate in the multiple dose treatment arm (99.5%) was also significantly higher than in the single dose arm (68.9%) with difference t (101) =5.38; 95% CI 230.95-505.36; P < 0.001.
CONCLUSION
The single dose regimen of mebendazole for the treatment of hookworm infections showed poor cure and egg reduction rates, while the multiple doses revealed satisfactory. Although multiple dose regimen administration is a bit more complex than the single dose, we strongly encourage replacing it with multiple dose regimen during deworming programs in hookworm endemic areas.
TRIAL REGISTRATION
This trial is retrospectively registered in www.pactr.org, number PACTR201911466695052 on November 26, 2019.",2020,Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR = 55.125; 95% CI: 11.92-254.9; P < 0.001.,"['eligible hookworm-positive children', 'school-aged children', 'One hundred eight children, 54 in each treatment arm had completed baseline data and received allocated treatment', 'school children', 'school-aged children (6-14\u2009years old) in Burie and Debre Elias towns, Northwest Ethiopia', 'One hundred three children had completed follow-up data records and included for the final efficacy analysis']","['Mebendazole', 'albendazole or mebendazole', 'mebendazole']","['poor cure and egg reduction rates', 'cure and egg reduction rates', 'Cure rate against hookworm', 'egg reduction rate']","[{'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0025023', 'cui_str': 'Mebendazole'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}]",108.0,0.16424,Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR = 55.125; 95% CI: 11.92-254.9; P < 0.001.,"[{'ForeName': 'Tegegne', 'Initials': 'T', 'LastName': 'Eshetu', 'Affiliation': 'Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, P.O.Box: 196, Gondar, Ethiopia. tegegneeshetu5@gmail.com.'}, {'ForeName': 'Mulugeta', 'Initials': 'M', 'LastName': 'Aemero', 'Affiliation': 'Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, P.O.Box: 196, Gondar, Ethiopia.'}, {'ForeName': 'Ayalew Jejaw', 'Initials': 'AJ', 'LastName': 'Zeleke', 'Affiliation': 'Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, P.O.Box: 196, Gondar, Ethiopia.'}]",BMC infectious diseases,['10.1186/s12879-020-05097-1']
3096,32460840,A combined individual and group-based stabilization and skill training intervention versus treatment as usual for patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care - a study protocol for a randomized controlled trial.,"BACKGROUND
Suffering linked to previous interpersonal trauma is common among patients in mental health care. Diagnostic labels may vary, but the clinical picture is often characterized by long-lasting and complex psychological and somatic symptoms, subjective distress and reduced quality of health and life. A substantial proportion of patients do not recover after individual treatment in ordinary specialized mental healthcare settings, despite the proven usefulness of individual trauma-specific treatments. The therapeutic factors that arise in group settings, such as normalization, shame reduction and corrective relational experiences, may be particularly useful for trauma survivors. However, evidence in support of group treatment for trauma survivors is scarce. This study aims to test whether combining a novel group intervention to individual treatment is superior to conventional individual out-patient treatment in an ordinary community mental health hospital.
METHODS
In a single-site, non-blinded, randomized controlled trial (RCT), the effect of a combined group-based stabilization and skill-training (SST) intervention added to individual treatment will be compared to conventional treatment (treatment as usual, TAU) alone. Participants (N = 160) with ongoing and long-lasting reactions related to known adverse life events from the past will be recruited among patients at general outpatient clinics in a community mental health centre at St. Olav's University Hospital, Trondheim, Norway. Following baseline assessment and randomization, participants will complete follow-up measures at 4, 8, 13 and 19 months post-baseline. The primary outcome is personal recovery (The questionnaire about the process of recovery , QPR). Secondary outcomes include (1) self-reported symptoms of posttraumatic stress, general mental and somatic health symptoms, well-being, functional impairment and client satisfaction, (2) immunological and endocrine response measured in blood samples and (3) national registry data on occupational status, use of mental health services and pharmacological treatment. Additionally, mechanisms of change via posttraumatic cognitions will be examined.
DISCUSSION
The addition of a group-based intervention to individual treatment for trauma survivors might prove to be an efficient way to meet the need of long-lasting high-intensity treatment in a large group of patients in mental health care, thereby reducing their suffering and increasing their psychosocial functioning.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03887559. Registered on 25 March 2019.",2020,"This study aims to test whether combining a novel group intervention to individual treatment is superior to conventional individual out-patient treatment in an ordinary community mental health hospital.
","[""Participants (N\u2009=\u2009160) with ongoing and long-lasting reactions related to known adverse life events from the past will be recruited among patients at general outpatient clinics in a community mental health centre at St. Olav's University Hospital, Trondheim, Norway"", 'ordinary community mental health hospital', 'patients in mental health care', 'patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care - a study protocol']","['combined group-based stabilization and skill-training (SST) intervention', 'combined individual and group-based stabilization and skill training intervention']","['1) self-reported symptoms of posttraumatic stress, general mental and somatic health symptoms, well-being, functional impairment and client satisfaction, (2) immunological and endocrine response measured in blood samples and (3) national registry data on occupational status, use of mental health services and pharmacological treatment', 'personal recovery (The questionnaire about the process of recovery , QPR']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0014006', 'cui_str': 'Occupational Status'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",,0.171637,"This study aims to test whether combining a novel group intervention to individual treatment is superior to conventional individual out-patient treatment in an ordinary community mental health hospital.
","[{'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Holgersen', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway. katrine.hoyer.holgersen@stolav.no.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Brønstad', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jensen', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brattland', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Hassel', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arentz', 'Affiliation': 'Department of Mental Health (IPH), Faculty of Medicine and Health Sciences, NTNU, Trondheim, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lara-Cabrera', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Skjervold', 'Affiliation': 'Tiller Community Mental Health Centre, Department of Mental Health, Tiller DPS, St. Olavs Hospital HF, Postboks 3250, Torgarden, 7006, Trondheim, Norway.'}]",Trials,['10.1186/s13063-020-04297-z']
3097,32460879,Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial.,"BACKGROUND
There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice.
METHODS/DESIGN
DOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial.
DISCUSSION
Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03851835. Registered on 22 February 2019.",2020,"DISCUSSION
Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis.","['In September 2019 the study began recruiting children aged 6\u2009months to 18\u2009years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72\u2009h of gastroenteritis symptoms and who were administered a dose of', 'six Canadian pediatric emergency departments (EDs', '1030 children (1:1 allocation via an internet-based, third-party, randomization service', 'children presenting to emergency departments with vomiting secondary to acute gastroenteritis', 'children focusing on post-emergency department visit and patient-centered outcomes', 'children with acute gastroenteritis', 'Pediatric Gastroenteritis', 'pediatric Acute GastroEnteritis (DOSE-AGE']","['ondansetron', 'Multi-dose Oral Ondansetron', 'ondansetron oral solution or placebo', 'placebo']","['duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety', 'development of moderate-to-severe gastroenteritis in the 7\u2009days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1238268', 'cui_str': 'Ondansetron Oral Solution [Zofran]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1030.0,0.588411,"DISCUSSION
Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Sections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Stephen.freedman@ahs.ca.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williamson-Urquhart', 'Affiliation': ""Alberta Children's Hospital, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'The Hospital for Sick Children, Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Pechlivanoglou', 'Affiliation': 'The Hospital for Sick Children, Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Hopkin', 'Affiliation': 'Institute of Health Economics, Edmonton, AB, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Departments of Pediatric Emergency Medicine and Pediatrics, CHU Sainte-Justine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Plint', 'Affiliation': ""Children's Hospital of Eastern Ontario, Departments of Pediatric and Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dixon', 'Affiliation': ""Stollery Children's Hospital, Department of Pediatrics, University of Alberta, Women and Children's Health Research Institute, Edmonton, AB, Canada.""}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Beer', 'Affiliation': ""Max Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Joubert', 'Affiliation': ""Division of Paediatric Emergency Medicine, Department of Paediatrics, Children's Hospital LHSC, Western University, London, ON, Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Institute of Health Economics and the Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'Divisions of Emergency Medicine and Clinical Pharmacology and Toxicology, Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': ""Max Rady College of Medicine, Pediatrics and Child Health, Rady Faculty of Health Sciences, University of Manitoba, and the Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04347-6']
3098,32460885,"A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson's disease: a study protocol for a randomised controlled trial.","BACKGROUND
Parkinson's disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to Speech and Language Therapy (SLT) intervention are commonly available: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals' needs per local practice typically consisting of six to eight weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive.
METHODS/DESIGN
PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation.
PRIMARY OUTCOME
Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. Mixed-methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation. The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK.
DISCUSSION
The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions.
TRIAL REGISTRATION
International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016.",2020,The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT.,"[""Parkinson's disease (PD) affects approximately 145,519 people in the UK"", ""Parkinson's disease"", 'Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled']","['NHS SLT or LSVT LOUD® via a central computer-generated programme', 'SLT', 'NHS SLT or LSVT LOUD®', 'NHS SLT', 'intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation', 'Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy', 'Speech and Language Therapy (SLT) intervention']","['Voice Handicap Index (VHI) total score', ""VHI subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5\u2009L; ICECAP-O; resource utilisation; adverse events and carer quality of life""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}]","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0037831', 'cui_str': 'Speech therapy'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",546.0,0.162409,The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT.,"[{'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Sackley', 'Affiliation': ""Population Health Sciences, Addison House, King's College London, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rick', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK. caroline.rick@nottingham.ac.uk.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Au', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Brady', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Beaton', 'Affiliation': 'Queen Elizabeth Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Burton', 'Affiliation': 'School of Allied and Public Health Professions, Canterbury Christ church University, Canterbury, CT1 1QU, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Caulfield', 'Affiliation': 'Bangor Institute for Health and Medical Research, School of Healthcare Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dickson', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dowling', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hughes', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics, University of Birmingham, Birmingham,, B15 2TT, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Masterson-Algar', 'Affiliation': 'Bangor Institute for Health and Medical Research, School of Healthcare Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nicoll', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Smith', 'Affiliation': 'Division of Psychology and Language Science, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Woolley', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Clarke', 'Affiliation': 'Institute for Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04354-7']
3099,32467653,Improving Developmental Abilities in Infants With Tuberous Sclerosis Complex: A Pilot Behavioral Intervention Study.,"Tuberous sclerosis complex (TSC) is a rare genetic syndrome that confers risk for neurodevelopmental disorders, including autism spectrum disorder and intellectual disability. Delays in social communication and early cognitive abilities are observable as early as 9 months of age in children with TSC; however, there have been no studies of early behavioral intervention in TSC. We conducted a pilot study of an evidence-based, parent-mediated behavioral intervention focused on improving early social communication and play skills in 5 children with TSC (aged 1-3 years). Participants showed maintenance and sometimes gains in developmental abilities, relative to peers, following intervention. Parents generally found the intervention to be helpful and were able to administer the intervention with fidelity. Preliminary results demonstrate initial feasibility of an early play-based, parent-mediated intervention and support the need for a large-scale, randomized clinical trial in TSC.",2020,"Participants showed maintenance and sometimes gains in developmental abilities, relative to peers, following intervention.","['5 children with TSC (aged 1-3 years', 'Infants With Tuberous Sclerosis Complex', 'children with TSC']",['parent-mediated behavioral intervention'],"['social communication and early cognitive abilities', 'early social communication and play skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",5.0,0.0468889,"Participants showed maintenance and sometimes gains in developmental abilities, relative to peers, following intervention.","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'McDonald', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Hyde', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'April Boin', 'Initials': 'AB', 'LastName': 'Choi', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Gulsrud', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}, {'ForeName': 'Shafali S', 'Initials': 'SS', 'LastName': 'Jeste', 'Affiliation': ""UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson).""}]",Infants and young children,['10.1097/iyc.0000000000000160']
3100,32467655,Functional outcomes comparative analysis of cemented and uncemented total knee arthroplasty.,"Introduction
Cementless knee arthroplasty becomes more and more popular worldwide. At the beginning of endoprosthetics era, cementless implants showed unsatisfactory results. However, surgical technologies develop rapidly and nowadays the cementless fixation shows better outcomes.
Objectives
To analyze the experience of total knee arthroplasty using cementless fixation for the treatment of advanced arthritis of the knee.
Methods
We operated on 130 patients. The mean follow-up duration was 36 months. In 70 patients we used cementless fixation and in 60 patients we used implants with cemented fixation. To evaluate the results, we used KOOS scale and WOMAC scale. We also evaluated the mean duration of surgical intervention and blood loss.
Results
In the cementless group WOMAC and KOOS scales scores before the operation were 198,2 (±35.7) and 23,1 (±3.4), respectively, and in the cemented group it was 199.3(±36.8) and 24.9 (±2.1), respectively(p > 0,05). One year after the operation, KOOS and WOMAC scores were 54.5(±12.6) and 83.6(±8,.2) in the cementless group and 78.9(±4.6) and 66.9(±5.7) in the cemented group(p < 0,05)., respectively. Intraoperative blood loss was 255(±89,3) in the cemented group and 315(±52,1) in cementless group(p < 0,05). Postoperative blood loss was 515(±119, 5) and 440(±129,3)) (p < 0,05), respectively. Mean duration of intervention was 78 min (±6,8) in cemented group and 64 min (±8,7) in cementless group(p < 0,05).
Conclusions
1We have better functional results using implants with cementless fixation.2There was a greater intraoperative and postoperative blood loss in cementless group.3Cementless knee arthroplasty associated with shorter duration of intervention than cemented.",2020,"Intraoperative blood loss was 255(±89,3) in the cemented group and 315(±52,1) in cementless group(p ","['advanced arthritis of the knee', '130 patients', 'cementless group(p', '70 patients we used cementless fixation and in 60 patients we used implants with cemented fixation']","['total knee arthroplasty using cementless fixation', 'cemented and uncemented total knee arthroplasty']","['Mean duration of intervention', 'KOOS scale and WOMAC scale', 'KOOS and WOMAC scores', 'mean duration of surgical intervention and blood loss', 'KOOS scales scores', 'Postoperative blood loss was 515(±119, 5) and 440(±129,3', 'Intraoperative blood loss']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0240111', 'cui_str': 'Arthritis of knee'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",130.0,0.0341711,"Intraoperative blood loss was 255(±89,3) in the cemented group and 315(±52,1) in cementless group(p ","[{'ForeName': 'V Yu', 'Initials': 'VY', 'LastName': 'Murylev', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Muzychenkov', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Zhuchkov', 'Affiliation': 'S. P. Botkin Moscow City Clinical Hospital, Russia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Tsygin', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Rigin', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Elizarov', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Kukovenko', 'Affiliation': 'I.M.Sechenov First Moscow State Medical University, Russia.'}]",Journal of orthopaedics,['10.1016/j.jor.2020.04.019']
3101,32467688,"The effect of levocetirizine and montelukast on clinical symptoms, serum level and skin expression of COX-1 and COX-2 enzymes in patients suffering from chronic autoimmune urticaria - a pilot study.","Introduction
Chronic autoimmune urticaria (CAU) lasts over 6 weeks and is characterized by circulating IgE autoantibodies or IgG against IgE or IgE receptor.
Aim
To assess the clinical, laboratory and histological effects of 4-week levocetirizine and montelukast therapy in patients suffering from CAU.
Material and methods
Of 296 tested patients with chronic urticaria 40 had a positive ASST test. Only 17 (16 female/1 male; medium age: 44 years) fulfilled all study inclusion/exclusion criteria. The study was designed as an open, randomized trial with two arms: levocetirizine or montelukast treatment for 4 weeks following a 2-week wash-out period. All participants completed urticaria activity score (UAS) and visual analogue scale (VAS) questionnaires before and after both therapies. Blood samples and skin bioptats were obtained before and after treatment to evaluate COX-1 and COX-2 serum concentrations and skin expression.
Results
Clinical response to therapy measured with the UAS and VAS was better in the levocetirizine group. Both drugs caused a significant decrease in COX-1 and COX-2 serum level. COX-1 and COX-2 expression in epidermal and dermal inflammatory infiltration did not change significantly in either study group, but a significant decrease of COX-1 expression was observed when the groups were combined for analysis, and the decrease in COX-2 expression in the epidermis was of borderline significance.
Conclusions
The effectiveness of levocetirizine and montelukast in treating CAU may be partly related to the reduction of COX-1 and COX-2 serum level and tissue expression, but further studies on a larger group of patients are needed to support this observation.",2020,"COX-1 and COX-2 expression in epidermal and dermal inflammatory infiltration did not change significantly in either study group, but a significant decrease of COX-1 expression was observed when the groups were combined for analysis, and the decrease in COX-2 expression in the epidermis was of borderline significance.
","['296 tested patients with chronic urticaria 40 had a positive ASST test', 'patients suffering from chronic autoimmune urticaria - a pilot study', 'patients suffering from CAU', 'Only 17 (16 female/1 male; medium age: 44 years) fulfilled all study inclusion/exclusion criteria']","['levocetirizine or montelukast', 'levocetirizine', 'levocetirizine and montelukast', 'levocetirizine and montelukast therapy']","['clinical symptoms, serum level and skin expression of COX-1 and COX-2 enzymes', 'COX-1 expression', 'COX-1 and COX-2 expression in epidermal and dermal inflammatory infiltration', 'COX-1 and COX-2 serum concentrations and skin expression', 'COX-2 expression', 'COX-1 and COX-2 serum level', 'Blood samples and skin bioptats', 'urticaria activity score (UAS) and visual analogue scale (VAS) questionnaires', 'UAS and VAS']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263338', 'cui_str': 'Chronic urticaria'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1304193', 'cui_str': 'Chronic autoimmune urticaria'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1565830', 'cui_str': 'PTGS1 protein, human'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0302158', 'cui_str': 'Leucocytic infiltrate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",296.0,0.0205452,"COX-1 and COX-2 expression in epidermal and dermal inflammatory infiltration did not change significantly in either study group, but a significant decrease of COX-1 expression was observed when the groups were combined for analysis, and the decrease in COX-2 expression in the epidermis was of borderline significance.
","[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Korczyñska-Krawczyk', 'Affiliation': 'Department of Internal Medicine, Asthma and Allergy, Norbert Barlicki Memorial University Hospital No. 1, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Kupryś-Lipiñska', 'Affiliation': 'Department of Internal Medicine, Asthma and Allergy, Norbert Barlicki Memorial University Hospital No. 1, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kupczyk', 'Affiliation': 'Department of Internal Medicine, Asthma and Allergy, Norbert Barlicki Memorial University Hospital No. 1, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Wągrowska-Danilewicz', 'Affiliation': 'Department of Nephropathology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Szemraj', 'Affiliation': 'Department of Medical Biochemistry, Faculty of Health Sciences with the Division of Nursing and Midwifery, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Bienias', 'Affiliation': 'Department of Dermatology and Pediatric and Oncologic Dermatology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Narbutt', 'Affiliation': 'Department of Dermatology and Pediatric and Oncologic Dermatology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Śmigielski', 'Affiliation': 'Social and Technical Department, State Higher Vocational School, Konin, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kuna', 'Affiliation': 'Department of Internal Medicine, Asthma and Allergy, Norbert Barlicki Memorial University Hospital No. 1, Medical University of Lodz, Lodz, Poland.'}]",Postepy dermatologii i alergologii,['10.5114/ada.2018.79731']
3102,32469184,"Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer.","BACKGROUND
Preliminary trial results showed that enzalutamide significantly improved metastasis-free survival among men who had nonmetastatic, castration-resistant prostate cancer and rapidly increasing prostate-specific antigen (PSA) levels while taking androgen-deprivation therapy. Results from the final analysis of overall survival have not yet been reported.
METHODS
In this double-blind, phase 3 trial, men with nonmetastatic, castration-resistant prostate cancer (defined on the basis of conventional imaging and a PSA doubling time of ≤10 months) who were continuing to receive androgen-deprivation therapy were randomly assigned (in a 2:1 ratio) to receive enzalutamide at a dose of 160 mg or placebo once daily. Overall survival was assessed with a group sequential testing procedure and an O'Brien-Fleming-type alpha-spending function.
RESULTS
As of October 15, 2019, a total of 288 of 933 patients (31%) in the enzalutamide group and 178 of 468 (38%) in the placebo group had died. Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P = 0.001). The exposure-adjusted rate of adverse events of grade 3 or higher was 17 per 100 patient-years in the enzalutamide group and 20 per 100 patient-years in the placebo group. Adverse events in the enzalutamide group were consistent with those previously reported for enzalutamide; the most frequently reported events were fatigue and musculoskeletal events.
CONCLUSIONS
Enzalutamide plus androgen-deprivation therapy resulted in longer median overall survival than placebo plus androgen-deprivation therapy among men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising PSA level. The risk of death associated with enzalutamide was 27% lower than with placebo. Adverse events were consistent with the established safety profile of enzalutamide. (Funded by Pfizer and Astellas Pharma; PROSPER ClinicalTrials.gov number, NCT02003924.).",2020,"Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P = 0.001).","['men who had nonmetastatic, castration-resistant prostate cancer', 'men with nonmetastatic, castration-resistant prostate cancer', 'men with nonmetastatic, castration-resistant prostate cancer (defined on the basis of conventional imaging and a PSA doubling time of ≤10 months) who were continuing to receive androgen-deprivation therapy']","['Enzalutamide plus androgen-deprivation therapy', 'placebo plus androgen-deprivation therapy', 'enzalutamide', 'enzalutamide at a dose of 160 mg or placebo', 'placebo']","['Median overall survival', 'risk of death', 'Adverse events', 'Overall survival', 'died', 'median overall survival', 'metastasis-free survival', 'Enzalutamide and Survival', 'fatigue and musculoskeletal events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.755206,"Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P = 0.001).","[{'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Penson', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Ubirajara', 'Initials': 'U', 'LastName': 'Ferreira', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Madziarska', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Kolinsky', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Daniel I G', 'Initials': 'DIG', 'LastName': 'Cubero', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Noerby', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Zohren', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Modelska', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2003892']
3103,32469304,Pharmacodynamic evaluation of L-carnitine and piracetam in muscle injury induced by the chronic use of simvastatin
.,"OBJECTIVES
To evaluate the effect of L-carnitine and piracetam on the muscle injury induced by simvastatin in healthy male subjects during the therapy with oral doses of 10 mL of a solution containing L-carnitine 100 mg/mL + piracetam 80 mg/mL (test group) or placebo (control group) and 40 mg simvastatin once a day during 35 consecutive days. The effect of L-carnitine and piracetam in the reduction of myopathic symptomatology caused by exercise, as well as safety and tolerability were also evaluated.
MATERIALS AND METHODS
This study was performed on two different occasions, of which 42 subjects were investigated on occasion 1 and 19 on occasion 2. Discomfort or pain was evaluated according to modified Borg scale. Serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase (γ-GT), creatine kinase (CK), and lactic dehydrogenase (LDH) were evaluated on the 4th, 11th, 18th, 25th, and 32nd day after therapy, and before and until 4 hours after an exercise test performed on a treadmill on day 36.
RESULTS
A higher incidence of pain or discomfort was observed in the control group than in the test group, mainly in occasion 1 (29% vs. 62% experienced pain or discomfort in any period, p = 0.0295). The serum levels of AST, ALT, and LDH were statistically different, with lower values in the test group compared to the control group.
CONCLUSION
Concomitant use of L-carnitine and piracetam might have a muscle-protective effect and protection against simvastatin-induced myalgia. Furthermore, the formulation was safe and well tolerated by the subjects investigated in this trial.
.",2020,"A higher incidence of pain or discomfort was observed in the control group than in the test group, mainly in occasion 1 (29% vs. 62% experienced pain or discomfort in any period, p = 0.0295).","['42 subjects were investigated on occasion 1 and 19 on occasion 2', 'healthy male subjects during the therapy with oral doses of 10 mL of a']","['L-carnitine and piracetam', 'simvastatin', 'solution containing L-carnitine 100 mg/mL + piracetam 80 mg/mL (test group) or placebo (control group) and 40 mg simvastatin']","['Discomfort or pain', 'safety and tolerability', 'serum levels of AST, ALT, and LDH', 'safe and well tolerated', 'pain or discomfort', 'Serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase (γ-GT), creatine kinase (CK), and lactic dehydrogenase (LDH']","[{'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0031977', 'cui_str': 'Piracetam'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",42.0,0.0436808,"A higher incidence of pain or discomfort was observed in the control group than in the test group, mainly in occasion 1 (29% vs. 62% experienced pain or discomfort in any period, p = 0.0295).","[{'ForeName': 'Renan Marcel Bonilha', 'Initials': 'RMB', 'LastName': 'Dezena', 'Affiliation': ''}, {'ForeName': 'Natalícia de Jesus', 'Initials': 'NJ', 'LastName': 'Antunes', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Campos', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ilha', 'Affiliation': ''}, {'ForeName': 'Ronilson A', 'Initials': 'RA', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Mendes', 'Affiliation': ''}, {'ForeName': 'Paulo César Pires', 'Initials': 'PCP', 'LastName': 'Rosa', 'Affiliation': ''}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'De Nucci', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203496']
3104,32469305,Bioavailability study of two 81-mg coated tablet formulations of acetylsalicylic acid in fed healthy subjects
.,"OBJECTIVE
To perform a comparative bioavailability study between a test (re-formulation) and a reference acetylsalicylic acid formulation (Ecasil-81, 81 mg coated tablet) in healthy subjects under fed condition.
MATERIALS AND METHODS
Healthy subjects (n = 48) were included in this monocentric, open-label, randomized, two-way crossover pharmacokinetic study. They received a single 81-mg oral dose of a test or a reference formulation of acetylsalicylic acid under fed condition, with a 7-day washout period between the treatments. Blood samples were collected over a period of 36 hours. The salicylic acid plasma concentration was measured by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). Pharmacokinetic analysis was performed using WinNonlin software.
RESULTS
The geometric mean and 90% confidence interval of test/reference formulation ratios were 109.32% (102.54 - 116.54%) and 106.94% (102.97 - 111.07%) for salicylic acid C max and AUC 0-last , respectively. Food decreased the AUC and C max (p < 0.001) and delayed the t max (p = 0.0077). The investigated women presented higher AUC 0-∞ and C max values (p < 0.001) than men. The clinical and laboratory exams did not show significant alterations.
CONCLUSION
The re-formulation is bioequivalent to the reference formulation regarding the absorption extent and rate in fed healthy subjects. The administration of acetylsalicylic acid with food decreased its bioavailability. Moreover, differences in salicylic acid disposition related to sex were observed. The treatments were well tolerated by the investigated subjects.
.",2020,The investigated women presented higher AUC 0-∞ and C max values (p < 0.001) than men.,"['healthy subjects under fed condition', 'fed\xa0healthy subjects\u2029', 'fed healthy subjects', 'Healthy subjects (n\xa0=\xa048']","['acetylsalicylic acid', 'acetylsalicylic acid formulation (Ecasil-81, 81\xa0mg coated tablet']","['salicylic acid disposition', 'Blood samples', 'bioavailability', 'geometric mean and 90% confidence interval of test/reference formulation ratios', 'salicylic acid plasma concentration', 'AUC and C max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",48.0,0.0240262,The investigated women presented higher AUC 0-∞ and C max values (p < 0.001) than men.,"[{'ForeName': 'Raul Cleverson', 'Initials': 'RC', 'LastName': 'Dolores', 'Affiliation': ''}, {'ForeName': 'Natalícia de Jesus', 'Initials': 'NJ', 'LastName': 'Antunes', 'Affiliation': ''}, {'ForeName': 'Alexandre Scremin', 'Initials': 'AS', 'LastName': 'Czezacki', 'Affiliation': ''}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Previato', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Campos', 'Affiliation': ''}, {'ForeName': 'Ronilson A', 'Initials': 'RA', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Mendes', 'Affiliation': ''}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'De Nucci', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203575']
3105,32474584,Potentially inappropriate medication use in older adults with mild-moderate Alzheimer's disease: prevalence and associations with adverse events.,"AIM
Potentially inappropriate medication (PIM) use is prevalent in older adults and is associated with adverse events, hospitalisation and mortality. We assessed the patterns and associations of PIM use in older adults with mild-to-moderate Alzheimer's Disease (AD), who may represent a particularly vulnerable group.
DESIGN
Analysis of data from NILVad, an 18-month Randomised Control Trial of Nilvadapine in mild-to-moderate AD. The v2 STOPP criteria were applied in duplicate to identify PIM use. Associations between PIM use and adverse events/unscheduled healthcare visits in addition to the associations between PIM use and AD progression were evaluated.
SETTING AND PARTICIPANTS
448 older adults with mild-to-moderate AD from 23 centres in nine European countries.
RESULTS
Of 448 participants (mean age: 72.56 ± 8.19 years), over half (55.8%) were prescribed a PIM with 30.1% being prescribed 2+ PIMs. The most frequent PIMs were (i) long-term benzodiazepines (11.6% N = 52/448), (ii) selective serotonin reuptake inhibitors without appropriate indication (11.1% N = 50/448), and (iii) Proton-Pump Inhibitors (PPIs) without appropriate indication (10.7% N = 48/448). Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13-1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17-1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03-1.30, P = 0.016) and GP visits (IRR 1.22, 1.15-1.28, P < 0.001). PIM use was not associated with dementia progression.
CONCLUSIONS AND IMPLICATIONS
PIM use is highly prevalent in mild-to-moderate AD and is associated with adverse events and unscheduled healthcare utilisation. Further attention to de-prescribing in this vulnerable group is warranted.",2020,"Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13-1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17-1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03-1.30, P = 0.016) and GP visits (IRR 1.22, 1.15-1.28, P < 0.001).","['448 older adults with mild-to-moderate AD from 23 centres in nine European countries', 'Of 448 participants (mean age: 72.56\u2009±\u20098.19\xa0years), over half (55.8%) were prescribed a PIM with 30.1% being prescribed 2+ PIMs', 'older adults', ""older adults with mild-moderate Alzheimer's disease"", 'mild-to-moderate AD', ""older adults with mild-to-moderate Alzheimer's Disease (AD""]","['benzodiazepines', 'Nilvadapine', 'inappropriate medication (PIM']","['unscheduled hospitalisations', 'GP visits', 'serious adverse events', 'risk of adverse events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}]","[{'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",448.0,0.0647382,"Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13-1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17-1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03-1.30, P = 0.016) and GP visits (IRR 1.22, 1.15-1.28, P < 0.001).","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Adam H', 'Initials': 'AH', 'LastName': 'Dyer', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lawlor', 'Affiliation': 'Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Kennelly', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Age and ageing,['10.1093/ageing/afaa067']
3106,32474650,Efficacy of teriparatide compared with risedronate on FRAX ® -defined major osteoporotic fractures: results of the VERO clinical trial.,"FRAX ® calculates the 10-year probability of major osteoporotic fractures (MOF), which are considered to have a greater clinical impact than other fractures. Our results suggest that, in postmenopausal women with severe osteoporosis, those treated with teriparatide had a 60% lower risk of FRAX ® -defined MOF compared with those treated with risedronate.
INTRODUCTION
The VERO trial was an active-controlled fracture endpoint clinical trial that enrolled postmenopausal women with severe osteoporosis. After 24 months, a 52% reduction in the hazard ratio (HR) of clinical fractures was reported in patients randomized to teriparatide compared with risedronate. We examined fracture results restricted to FRAX ® -defined major osteoporotic fractures (MOF), which include clinical vertebral, hip, humerus, and forearm fractures.
METHODS
In total, 1360 postmenopausal women (mean age 72.1 years) were randomized to receive subcutaneous daily teriparatide (20 μg) or oral weekly risedronate (35 mg). Patient cumulative incidence of ≥ 1 FRAX ® -defined MOF and of all clinical fractures were estimated by Kaplan-Meier analyses, and the comparison between treatments was based on the stratified log-rank test. Additionally, an extended Cox model was used to estimate HRs at different time points. Incidence fracture rates were estimated at each 6-month interval.
RESULTS
After 24 months, 16 (2.6%) patients in the teriparatide group had ≥ 1 low trauma FRAX ® -defined MOF compared with 40 patients (6.4%) in the risedronate group (HR 0.40; 95% CI 0.23-0.68; p = 0.001). Clinical vertebral and radius fractures were the most frequent FRAX ® -defined MOF sites. The largest difference in incidence rates of both FRAX ® -defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period. There was a statistically significant reduction in fractures between groups as early as 7 months for both categories of clinical fractures analyzed.
CONCLUSION
In postmenopausal women with severe osteoporosis, treatment with teriparatide was more efficacious than risedronate, with a 60% lower risk of FRAX ® -defined MOF during the 24-month treatment period. Fracture risk was statistically significantly reduced at 7 months of treatment.
CLINICAL TRIAL INFORMATION
ClinicalTrials.gov Identifier: NCT01709110 EudraCT Number: 2012-000123-41.",2020,The largest difference in incidence rates of both FRAX ® -defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period.,"['FRAX ® -defined major osteoporotic fractures', '1360 postmenopausal women (mean age 72.1 years', 'enrolled postmenopausal women with severe osteoporosis', 'postmenopausal women with severe osteoporosis', 'major osteoporotic fractures (MOF']","['teriparatide', 'risedronate', 'subcutaneous daily teriparatide (20 μg) or oral weekly risedronate']","['low trauma FRAX ® -defined MOF', 'fractures', 'Incidence fracture rates', 'hazard ratio (HR) of clinical fractures', 'Fracture risk']","[{'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1360.0,0.063252,The largest difference in incidence rates of both FRAX ® -defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period.,"[{'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Body', 'Affiliation': 'CHU Brugmann, Université Libre de Bruxelles (ULB), Brussels, Belgium. jean-jacques.body@chu-brugmann.be.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Marin', 'Affiliation': 'Lilly Research Center Europe, Madrid, Spain.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'C A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Centro Paulista de Investigaçao Clínica, Sao Paulo, Brazil.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'López-Romero', 'Affiliation': 'Lilly Research Center Europe, Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Möricke', 'Affiliation': 'Institut Präventive Medizin & Klinische Forschung, Magdeburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Casado', 'Affiliation': 'University Hospital Parc Taulí Sabadell, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fahrleitner-Pammer', 'Affiliation': 'Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Stepan', 'Affiliation': 'Institute of Rheumatology and Faculty of Medicine 1, Charles University, Prague, Czech Republic.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': 'Regional Hospital, University of Orleans, Orleans, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Minisola', 'Affiliation': 'Sapienza Rome University, Rome, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Geusens', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05463-4']
3107,32474683,The use of whole-body cryotherapy: time- and dose-response investigation on circulating blood catecholamines and heart rate variability.,"PURPOSE
A predominance of parasympathetic drive is observed following cold exposure. Such modulation of the autonomic nervous system (ANS) is associated with faster post-exercise recovery. Within this context, whole-body cryotherapy (WBC) has been spreading in sport medicine, though the optimal temperature and frequency are unclear. The aim of this study was to examine the effects of different cryotherapy conditions on the sympathovagal balance.
METHODS
Forty healthy males were randomly assigned into five different groups (- 110 °C, - 60 °C, - 10 °C, control temperature [≃ 24 °C]) and undertook 5 WBC sessions over 5 consecutive days. Cardiac autonomic activity was assessed through heart rate variability (HRV) using power density of high frequency (HF), root-mean square difference of successive R-R intervals (RMSSD) and sympathovagal balance (LF/HF). Systemic sympathetic activity was assessed via circulating blood catecholamines.
RESULTS
Mean weekly RMSSD (pre: 48 ± 22 ms, post: 68 ± 29 ms) and HF (pre: 607 ± 692 ms 2 , post: 1271 ± 1180 ms 2 ) increased (p < 0.05) from pre to post WBC, only in the - 110 °C condition. A rise in plasma norepinephrine was found after the first - 110 °C WBC session only (pre: 173 ± 98, post: 352 ± 231 ng L -1 , p < 0.01); whereas, it was not significant after the 5th session (pre: 161 ± 120, post: 293 ± 245 ng L -1 , p = 0.15).
CONCLUSION
These results suggest that one - 110 °C WBC exposure is required to stimulate the ANS. After five daily exposures, a lower autonomic response was recorded compared to day one, therefore suggesting the development of physiological habituation to WBC.",2020,"After five daily exposures, a lower autonomic response was recorded compared to day one, therefore suggesting the development of physiological habituation to WBC.",['Forty healthy males'],['whole-body cryotherapy (WBC'],"['heart rate variability (HRV) using power density of high frequency (HF), root-mean square difference of successive R-R intervals (RMSSD) and sympathovagal balance (LF/HF', 'Cardiac autonomic activity', 'autonomic response', 'circulating blood catecholamines and heart rate variability', 'Systemic sympathetic activity', 'plasma norepinephrine']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0440738', 'cui_str': 'Circulating blood'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]",40.0,0.0263788,"After five daily exposures, a lower autonomic response was recorded compared to day one, therefore suggesting the development of physiological habituation to WBC.","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Louis', 'Affiliation': 'Research Institute for Sport and Exercise Sciences (RISES), Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK. J.B.Louis@ljmu.ac.uk.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Theurot', 'Affiliation': 'Laboratoire MOVE (EA 6314), Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Robert', 'Initials': 'JR', 'LastName': 'Filliard', 'Affiliation': 'Medical Department, French Institute of Sport (INSEP), 11 avenue du tremblay, 75012, Paris, France.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Volondat', 'Affiliation': 'Medical Department, French Institute of Sport (INSEP), 11 avenue du tremblay, 75012, Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Dugué', 'Affiliation': 'Laboratoire MOVE (EA 6314), Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuy', 'Affiliation': 'Laboratoire MOVE (EA 6314), Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}]",European journal of applied physiology,['10.1007/s00421-020-04406-5']
3108,32474710,Ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy: a double-blind randomized controlled trial.,"PURPOSE
In this double-blind randomized trial, we aimed to compare the postoperative pain, complications, and length of hospital stay in patients undergoing open hemorrhoidectomy under spinal anesthesia with or without the pudendal nerve block.
METHODS
Patients undergoing Milligan-Morgan hemorrhoidectomy under spinal anesthesia were randomized to undergo a pudendal nerve block or no intervention. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24, and 48 h; opioid administration; and length of hospital stay were recorded and analyzed.
RESULTS
Over the study period, 49 patients were included and 23 randomized in the treatment arm. No differences in terms of age, gender, and preoperative risk factors were noted between groups. The pain on the VAS at 6, 12, 24, and 48 h was 2.8 vs. 4.6 (p = 0.046), 3.4 vs. 4.7 (p = 0.697), 1.4 vs. 3.1 (p = 0.016), and 1.0 vs. 2.1 (p = 0.288) in the treatment and control groups respectively. No differences in opioids use or complications were noted. Length of hospital stay was 1.2 vs. 1.8 days respectively (p = 0.046). No complications directly associated to the pudendal nerve block were observed. Multivariate analysis revealed that the pudendal nerve block was an independent factor reducing the postoperative pain.
CONCLUSIONS
The ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy under spinal anesthesia showed a statistically significant reduction in postoperative pain and length of hospital stay. The proposed technique appeared to be safe and feasible and may be recommendable in patients undergoing open hemorrhoidectomy.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04251884.",2020,Length of hospital stay was 1.2 vs. 1.8 days respectively (p = 0.046).,"['patients undergoing open hemorrhoidectomy', 'patients undergoing open', 'Patients undergoing Milligan-Morgan hemorrhoidectomy under spinal anesthesia', '49 patients were included and 23 randomized in the treatment arm', 'patients undergoing open hemorrhoidectomy under spinal anesthesia', 'patients undergoing open hemorrhoidectomy under spinal anesthesia with or without the pudendal nerve block']","['Ultrasound-guided pudendal nerve block', 'pudendal nerve block or no intervention', 'hemorrhoidectomy']","['pain on the VAS', 'postoperative pain', 'Length of hospital stay', 'length of hospital stay', 'opioids use or complications', 'postoperative pain, complications, and length of hospital stay', 'pudendal nerve block', 'postoperative pain and length of hospital stay', 'Postoperative pain on the visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473074', 'cui_str': 'Open hemorrhoidectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0582521', 'cui_str': 'Morgan'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}]",49.0,0.227957,Length of hospital stay was 1.2 vs. 1.8 days respectively (p = 0.046).,"[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Di Giuseppe', 'Affiliation': 'Surgery, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Saporito', 'Affiliation': 'Anesthesiology, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'La Regina', 'Affiliation': 'Surgery, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Tasciotti', 'Affiliation': 'Anesthesiology, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Enea', 'Initials': 'E', 'LastName': 'Ghielmini', 'Affiliation': 'Surgery, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Vannelli', 'Affiliation': 'Surgery, Ospedale Valduce, Como, Italy.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Pini', 'Affiliation': 'Surgery, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mongelli', 'Affiliation': 'Surgery, Ospedale Regionale di Lugano, 6900, Lugano, Switzerland. francesco.mongelli@mail.com.'}]",International journal of colorectal disease,['10.1007/s00384-020-03630-x']
3109,32475159,Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study.,"Background The objectives of this study were to develop and test in real-world clinical practice the effectiveness of a comprehensive postacute stroke transitional care (TC) management program. Methods and Results The COMPASS study (Comprehensive Post-Acute Stroke Services) was a pragmatic cluster-randomized trial where the hospital was the unit of randomization. The intervention (COMPASS-TC) was initiated at 20 hospitals, and 20 hospitals provided their usual care. Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018. COMPASS-TC was patient-centered and assessed social and functional determinates of health to inform individualized care plans. Ninety-day outcomes were evaluated by blinded telephone interviewers. The primary outcome was functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls. The primary analysis was intention to treat. Of intervention hospitals, 58% had uninterrupted intervention delivery. Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit. The primary outcome was measured for 59% of patients and was not significantly influenced by the intervention. Mean Stroke Impact Scale-16 (±SD) was 80.6±21.1 in TC versus 79.9±21.4 in usual care. Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]). No other secondary outcomes differed. Conclusions Although designed according to the best available evidence with input from various stakeholders and consistent with Centers for Medicare and Medicaid Services TC policies, the COMPASS model of TC was not consistently incorporated into real-world health care. We found no significant effect of the intervention on functional status at 90 days post-discharge. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.",2020,"Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]).","['Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit', 'Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018']",['comprehensive postacute stroke transitional care (TC) management program'],"['Home blood pressure monitoring', 'functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls', 'Mean Stroke Impact Scale-16 (±SD', 'functional status']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0031228', 'cui_str': 'Hospital Personnel'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",6024.0,0.100697,"Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]).","[{'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC. (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.).'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC. (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.).'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill. (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.).'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Psioda', 'Affiliation': 'Department of Biostatistics, Collaborative Studies Coordinat-ing Center, University of North Carolina at Chapel Hill. (M.A.P.).'}, {'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC. (S.B.G.).'}, {'ForeName': 'Ralph B', 'Initials': 'RB', 'LastName': ""D'Agostino"", 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC. (R.B.D., W.T.A.).'}, {'ForeName': 'Mysha E', 'Initials': 'ME', 'LastName': 'Sissine', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC. (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.).'}, {'ForeName': 'Sylvia W', 'Initials': 'SW', 'LastName': 'Coleman', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC. (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.).'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill. (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.).'}, {'ForeName': 'Blair F', 'Initials': 'BF', 'LastName': 'Barton-Percival', 'Affiliation': 'Area Agency on Aging, Piedmont Triad Regional Council, Kernersville, NC (B.F.B.-P., A.G.C.).'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Prvu-Bettger', 'Affiliation': 'Duke University School of Medicine, Durham, NC (J.P.-B., A.M.P.).'}, {'ForeName': 'Adrienne G', 'Initials': 'AG', 'LastName': 'Calhoun', 'Affiliation': 'Area Agency on Aging, Piedmont Triad Regional Council, Kernersville, NC (B.F.B.-P., A.G.C.).'}, {'ForeName': 'Doyle M', 'Initials': 'DM', 'LastName': 'Cummings', 'Affiliation': 'Brody School of Medicine, East Carolina University, Greenville, NC (D.M.C.).'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'Department of Physical Therapy School of Health and Rehabilitation Science, University of Pittsburgh, PA (J.K.F.).'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Halladay', 'Affiliation': 'Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill (J.R.H.).'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kucharska-Newton', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill. (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.).'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Lundy-Lamm', 'Affiliation': 'Minority Women Health Alliance (TriStroke), Raleigh, NC (G.L.-L.).'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Lutz', 'Affiliation': 'University of North Carolina at Wilmington School of Nursing (B.J.L.).'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Mettam', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill. (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.).'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Pastva', 'Affiliation': 'Duke University School of Medicine, Durham, NC (J.P.-B., A.M.P.).'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Xenakis', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill. (J.G.X.).'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC. (R.B.D., W.T.A.).'}, {'ForeName': 'Meghan D', 'Initials': 'MD', 'LastName': 'Radman', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC. (P.W.D., C.D.B., M.E.S., S.W.C., M.D.R.).'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Vetter', 'Affiliation': 'American Heart Association, Raleigh, NC (B.V.).'}, {'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill. (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006285']
3110,32475171,Pressurized-bag irrigation versus hand-operated irrigation pumps during ureteroscopic laser lithotripsy: Comparison of infectious complications.,"Introduction & Objectives A variety of irrigation systems are available during ureteroscopy. We sought to compare gravity-driven pressure bags to hand-operated irrigation pumps; our primary outcome was post-operative infectious complications and secondary outcomes include unplanned re-admissions and emergency presentations. Methods A retrospective analysis of 234 patients undergoing flexible ureteropyeloscopy with laser lithotripsy by 24 supervised trainees over 6 years at a single teaching institution. Patients were divided into those who had procedures performed using gravity driven pressure bags fixed at 60-150 cmH20, versus those who had procedures using a hand operated irrigation pump capable of delivering 1-10mL per flush. Variables including surgical duration, hypotension, fever, sepsis, and haematuria were extracted from the charts, along with the surgical techniques and equipment utilised. Results There was no differences in gender, age, indication, or stone size in the two groups. Post-operative SIRS was significantly greater in the hand-assisted n=11/144 (7.6%) compared to the fixed irrigation group n=1/90 (1.1%); p= 0.032. Emergency room presentations were greater in the hand irrigation group n=46/144 (32%) versus n=12/90 (13%) in the pressure-bag irrigation, p= 0.002. Post-operative fever was also greater in the manual irrigation cohort compared to the continuous pressure cohort (13/144 (9%) versus 1/90 (1%), p= 0.011). No statistical difference was found between the two groups with respect to stone clearance and subsequent procedures required (p=0.123). Conclusions: This analysis suggests that using continuous flow irrigation at a fixed maximum pressure of 150mmHg (204 cmH20) or less may result in decreased pain, infection, and sepsis compared to hand-held pressure irrigation.",2020,"Emergency room presentations were greater in the hand irrigation group n=46/144 (32%) versus n=12/90 (13%) in the pressure-bag irrigation, p= 0.002.","['by 24 supervised trainees over 6 years at a single teaching institution', '234 patients undergoing']","['flexible ureteropyeloscopy with laser lithotripsy', 'gravity driven pressure bags fixed at 60-150 cmH20, versus those who had procedures using a hand operated irrigation pump capable of delivering 1-10mL per flush', 'ureteroscopic laser lithotripsy', 'Pressurized-bag irrigation versus hand-operated irrigation pumps', 'gravity-driven pressure bags to hand-operated irrigation pumps']","['Post-operative SIRS', 'pain, infection, and sepsis', 'unplanned re-admissions and emergency presentations', 'surgical duration, hypotension, fever, sepsis, and haematuria', 'Emergency room presentations', 'Post-operative fever']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",234.0,0.0437799,"Emergency room presentations were greater in the hand irrigation group n=46/144 (32%) versus n=12/90 (13%) in the pressure-bag irrigation, p= 0.002.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Farag', 'Affiliation': 'Austin Health, 3805, UROLOGY, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Brennan', 'Initials': 'B', 'LastName': 'Timm', 'Affiliation': 'Austin Health, 3805, 145 Studley Rd, Heidelberg, Heidelberg, Australia, 3084; bttimmz@gmail.com.'}, {'ForeName': 'Niall F', 'Initials': 'NF', 'LastName': 'Davis', 'Affiliation': 'Tallaght Hospital, Department of Urology, Dublin 24, Co Dublin, Dublin, Ireland; nialldavis2001@yahoo.com.'}, {'ForeName': 'Lih-Ming', 'Initials': 'LM', 'LastName': 'Wong', 'Affiliation': 'St Vincents Hospital, Urology, 41 Victoria Parade, Fitzroy, Melbourne, Victoria, Australia, 3065; lihmingwong@gmail.com.'}, {'ForeName': 'Damien M', 'Initials': 'DM', 'LastName': 'Bolton', 'Affiliation': 'Austin Health, 3805, Department of Urology, 5/210 Burgundy street, Heidelberg, Victoria, Australia, 3084.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Jack', 'Affiliation': 'The Austin Hospital, Urology, Melbourne, Victoria, Australia; gregory.jack@austin.org.au.'}]",Journal of endourology,['10.1089/end.2020.0148']
3111,32475182,Immediate effect of voluntary-induced stepping response training on protective stepping in persons with chronic stroke: a randomized controlled trial.,"Purpose: To compare the immediate effects of voluntary-induced stepping response training (VSR) and DynSTABLE perturbation training (DST) on protective stepping in patients with stroke. Methods: A randomized controlled trial (registration number: TCTR20170827001) was conducted in 34 patients with chronic stroke who were randomly allocated to the VSR ( n = 17) or DST ( n = 17) group. The VSR group was instructed to lean forward to induce protective stepping, while the DST group experienced support surface translation. All participants received one session of training (3 set, 10 min for each set with 10-minute rest in between). Step length, step width, number of steps and center of mass (CoM) position during protective stepping were assessed using a computer-assisted rehabilitation environment (CAREN) system prior to and immediately after training. Two-way ANOVA was used to compare between groups and times. Results: Both types of training resulted in an increase in step width, but step length increased and there was a more positive COM position exhibited following DST ( p < .05) than following VSR. Single-step incidence increased, whereas multiple-step incidence decreased significantly in both groups. Only participants in the VSR group generated protective stepping with the affected leg in a larger percentage of trials (27%) after training than before training. Conclusion: Both DST and VSR led to changes in protective stepping parameters after a single session of training. VSR may be a feasible alternative to equipment-based training but requires further study.Implication for RehabilitationVSR and DST trainings improved protective stepping in stroke.Step length and CoM control at foot touchdown increased after DST training.VSR training for 50 minutes led to increase affected stepping and reduce grasping.Step width, affected step length, and single step increased after both trainings.Without instrument, VSR increased steps execution and performance similar to DST.",2020,"Both types of training resulted in an increase in step width, but step length increased and there was a more positive COM position exhibited following DST ( p < .05) than following VSR.","['34 patients with chronic stroke', 'persons with chronic stroke', 'patients with stroke']","['voluntary-induced stepping response training', 'VSR', 'VSR training', 'DST', 'DST and VSR', 'RehabilitationVSR and DST trainings', 'voluntary-induced stepping response training (VSR) and DynSTABLE perturbation training (DST']","['multiple-step incidence', 'protective stepping parameters', 'Step length and CoM control at foot touchdown', 'protective stepping', 'stepping and reduce grasping', 'Step length, step width, number of steps and center of mass (CoM) position during protective stepping', 'step width, but step length', 'positive COM position', 'protective stepping in stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0262967', 'cui_str': 'Dihydrostreptomycin'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0009490', 'cui_str': 'Comoros islands'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",34.0,0.0403387,"Both types of training resulted in an increase in step width, but step length increased and there was a more positive COM position exhibited following DST ( p < .05) than following VSR.","[{'ForeName': 'Pornprom', 'Initials': 'P', 'LastName': 'Chayasit', 'Affiliation': 'Faculty of Physical Therapy, Srinakharinwirot University, Nakhon Nayok, Thailand.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Hollands', 'Affiliation': 'School of Health Sciences, University of Salford, Salford, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hollands', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Rumpa', 'Initials': 'R', 'LastName': 'Boonsinsukh', 'Affiliation': 'Faculty of Physical Therapy, Srinakharinwirot University, Nakhon Nayok, Thailand.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1769205']
3112,32475183,Does lopinavir measure up in the treatment of Covid-19?,"INTRODUCTION
Lopinavir in combination with ritonavir is approved for the treatment of HIV and has recently been subject to a clinical trial in severe Covid-19.
AREAS COVERED
This evaluation is of LOTUS China (the Lopinavir Trial for Suppression of SARS-Cov-2 in China), which was a randomised trial in hospitalised subjects with Covid-9 in a respiratory sample and pneumonia. As, in severe Covid-19, lopinavir/ritonavir had no beneficial effects but increased gastrointestinal adverse effects, this combination should not be used at this stage of Covid-19.
EXPERT OPINION
In my opinion, the rationale for undertaking a trial of lopinavir/ritonavir in Covid-19 was poor. The analysis of a modified intention to treat group analysis in LOTUS China may have introduced bias. After LOTUS China, there is probably no future for lopinavir in the treatment of severe Covid-19, but some clinical trials for prevention or in various stages of Covid-19 have recently started or are ongoing. The major limitation to these trials is that, as lopinavir does not inhibit Covid-19, it is unlikely to prevent infection, reduce viral load, or reduce severity. However, these trials may be worthwhile in finally determining whether lopinavir has any role in preventing or treating Covid-19.",2020,"After LOTUS China, there is probably no future for lopinavir in the treatment of severe Covid-19, but some clinical trials for prevention or in various stages of Covid-19 have recently started or are ongoing.",['hospitalised subjects with Covid-9 in a respiratory sample and pneumonia'],"['lopinavir', 'ritonavir', 'lopinavir/ritonavir']",['gastrointestinal adverse effects'],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444279', 'cui_str': 'Respiratory sample'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.148574,"After LOTUS China, there is probably no future for lopinavir in the treatment of severe Covid-19, but some clinical trials for prevention or in various stages of Covid-19 have recently started or are ongoing.","[{'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Doggrell', 'Affiliation': 'Faculty of Health, Queensland University of Technology , GPO 2434, QLD 4002, Brisbane, Australia.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1777277']
3113,32475274,2020 Chitranjan S. Ranawat Award: Perioperative essential amino acid supplementation suppresses rectus femoris muscle atrophy and accelerates early functional recovery following total knee arthroplasty.,"AIMS
The aim of this study was to assess the effectiveness of perioperative essential amino acid (EAA) supplementation to prevent rectus femoris muscle atrophy and facilitate early recovery of function after total knee arthroplasty (TKA).
METHODS
The study involved 60 patients who underwent unilateral TKA for primary knee osteo-arthritis (OA). This was a double-blind, placebo-controlled, randomized control trial with patients randomly allocated to two groups, 30 patients each: the essential amino acid supplementation (9 g daily) and placebo (lactose powder, 9 g daily) groups. Supplementation and placebo were provided from one week before to two weeks after surgery. The area of the rectus femoris muscle were measured by ultrasound imaging one month before surgery and one, two, three, and four weeks postoperatively. The serum albumin level, a visual analogue knee pain score, and mobility were also measured at each time point. The time to recovery of activities of daily living (ADLs) was recorded. Postoperative nutrition and physiotherapy were identical in both groups.
RESULTS
The mean relative change from baseline was as follows for the amino acid group: 116% in rectus femoris muscle area (71% to 206%); 95% in serum albumin (80% to 115%) and 39% in VAS pain (0% to 100%) at four weeks after surgery. These values in the placebo group were: 97% in muscle area (68 to 155); 89% in serum albumin (71% to 100%) and 56% in VAS pain four weeks after surgery (0% to 100%). All changes were statistically significant (p < 0.05). The mean time to recovery of ADLs was shorter in the amino acid group compared with the placebo group (p = 0.005).
CONCLUSION
Perioperative essential amino acid supplementation prevents rectus femoris muscle atrophy and accelerates early functional recovery after TKA. Cite this article: Bone Joint J 2020;102-B(6 Supple A):10-18.",2020,"The mean time to recovery of ADLs was shorter in the amino acid group compared with the placebo group (p = 0.005).
","['60 patients who underwent', 'total knee arthroplasty (TKA', 'total knee arthroplasty', 'patients randomly allocated to two groups, 30 patients each: the', '2020 Chitranjan S. Ranawat Award', 'for primary knee osteo-arthritis (OA']","['placebo (lactose powder', 'perioperative essential amino acid (EAA) supplementation', 'Perioperative essential amino acid supplementation', 'unilateral TKA', 'essential amino acid supplementation', 'placebo']","['serum albumin', 'serum albumin level, a visual analogue knee pain score, and mobility', 'Postoperative nutrition and physiotherapy', 'mean time to recovery of ADLs', 'time to recovery of activities of daily living (ADLs', 'VAS pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.422198,"The mean time to recovery of ADLs was shorter in the amino acid group compared with the placebo group (p = 0.005).
","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ueyama', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan, Department of Orthopaedic Surgery, Tanabe Central Hospital, Wakayama, Japan.'}, {'ForeName': 'Narihiro', 'Initials': 'N', 'LastName': 'Kanemoto', 'Affiliation': 'Department of Orthopaedic Surgery, Tanabe Central Hospital, Wakayama, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Minoda', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Orthopaedic Surgery, Tanabe Central Hospital, Wakayama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}]",The bone & joint journal,['10.1302/0301-620X.102B6.BJJ-2019-1370.R1']
3114,32469381,"Effects of Lower Body Positive Pressure Treadmill Training on Balance, Mobility and Lower Extremity Strength of Community-Dwelling Older Adults: A Pilot Study.","AIM
There is growing evidence that confirms the benefits of partially supporting a person's body weight during exercise. Lower body positive pressure (LBPP) unweighting is a new method of providing partial body weight support. This pilot study aims to investigate the effect of LBPP treadmill training on balance, mobility and lower extremity strength in community-dwelling older adults.
SUBJECTS
Five community-dwelling females aged 60-85 years with no neurological conditions or musculoskeletal injuries within the past year.
METHODS
The subjects participated in twice-weekly treadmill training sessions using LBPP at 80% of body weight. They exercised using their self-selected speed and incline for 20 min each session for 8 wks. Pre- and post-test measures included measures of balance, mobility and lower extremity strength.
RESULTS
Average self-selected speed more than doubled from initial to final training session. All subjects exercised within their safe limits, with no unsafe increases in blood pressure or heart rate, and no complaints of extremity pain or muscle soreness throughout the entire training period. Wilcoxon signed ranks test results showed statistically significant improvement in lower extremity strength.
CONCLUSIONS
In a sample of community-dwelling older adult females, an 8-wk regimen of treadmill exercise with LBPP unweighing resulted in improvements in lower extremity strength. The study provides preliminary support for the safe and effective use of LBPP treadmill training in community-dwelling older adults. Improvement in lower extremity strength may have significant implications in maintaining balance and mobility and decreasing fall risk in this population.",2020,The study provides preliminary support for the safe and effective use of LBPP treadmill training in community-dwelling older adults.,"['community-dwelling older adults', 'Five community-dwelling females aged 60-85 years with no neurological conditions or musculoskeletal injuries within the past year', 'community-dwelling older adult females', 'Community-Dwelling Older Adults']","['Lower Body Positive Pressure Treadmill Training', 'treadmill exercise with LBPP unweighing', 'LBPP treadmill training']","['blood pressure or heart rate, and no complaints of extremity pain or muscle soreness', 'lower extremity strength', 'measures of balance, mobility and lower extremity strength', 'Balance, Mobility and Lower Extremity Strength', 'balance, mobility and lower extremity strength']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C1444637', 'cui_str': 'Past'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0424577', 'cui_str': 'No complaints'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0112188,The study provides preliminary support for the safe and effective use of LBPP treadmill training in community-dwelling older adults.,"[{'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Lazaro', 'Affiliation': 'California State University Sacramento, 6000 J Street MS 6020, Sacramento, CA 95819, USA. Tel 916-278-5054, fax 916-278-6842. rolando.lazaro@csus.edu.'}]",Journal of allied health,[]
3115,32469414,Assessment of Patient and Caregiver Attitudes and Approaches to Decision-Making Regarding Bone Marrow Transplant for Sickle Cell Disease: A Qualitative Study.,"Importance
Bone marrow transplant (BMT) is a potentially curative treatment for sickle cell disease (SCD). Patient and caregiver attitudes toward BMT for SCD and the willingness to accept risks of BMT vary, but these attitudes are not well understood.
Objective
To understand patient and caregiver perceptions of and attitudes toward BMT for SCD and decision-making about BMT.
Design, Setting, and Participants
Qualitative study of interview transcripts from a convenience sample. Transcripts were from adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities. Interview transcripts were used from the needs assessment phase to develop a patient-decision aid in 2013 to 2014 (group 1) and from the baseline point in 2015 to 2016 (group 2) of the parent trial, a randomized clinical trial of adults and caregivers of patients with SCD to evaluate the effectiveness of a patient decision aid.
Main Outcomes and Measures
Participant perspectives on decision-making regarding BMT for SCD.
Results
Fifty-seven transcripts from adults with SCD and 50 transcripts from caregivers of patients with SCD were included. Median (interquartile range [IQR]) age of adults with SCD was 34 (21-50) years in group 1 and 30 (23-38) years in group 2. The median (IQR) age of caregivers was 42.5 (31-52) years in group 1 and 41 (35-46.5) years in group 2. Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants. Bone marrow transplant was perceived as a treatment option associated with serious risks. Reported attitudes toward BMT occurred on a continuum ranging from unfavorable to favorable. Participants reported serious decisional dilemma regarding BMT for SCD. Most participants expressed interest in learning about BMT or curative treatments.
Conclusions and Relevance
This qualitative study found a continuum in attitudes toward BMT for SCD and highlights the complexity of decision-making in BMT for SCD. Patients and families with SCD expressed an interest in learning about BMT. Future prospective studies of patient decision-making regarding BMT, especially in the context of emerging curative and novel disease-modifying therapies for SCD, are warranted.",2020,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"['adults with SCD and 50 transcripts from caregivers of patients with SCD', 'sickle cell disease (SCD', 'adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities', 'Sickle Cell Disease']",['Importance\n\n\nBone marrow transplant (BMT'],['decision-making regarding BMT for SCD'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]",,0.0344463,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"[{'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Deeksha', 'Initials': 'D', 'LastName': 'Katoch', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'Sinha', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maa-Ohui', 'Initials': 'MO', 'LastName': 'Quarmyne', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Krishnamurti', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6742']
3116,32469454,Changes in self-reported and observed parenting following a randomized control trial of parent-child interaction therapy for the treatment of preschool depression.,"BACKGROUND
Parenting in early childhood exerts substantial influence over children's emotional health and development. Using data from a randomized controlled trial of a novel treatment for early childhood depression, Parent-Child Interaction Therapy Emotion Development (PCIT-ED), we explored two broad dimensions of parenting (behavior and affect) to determine whether any changes could be detected following treatment when compared to those in a waitlist control condition.
METHOD
229 caregiver-child dyads, 114 randomly assigned to PCIT-ED for preschool-onset depression, and 115 assigned to a waitlist completed two structured interaction tasks at baseline and post-treatment. Interactions were later coded by observer's blind to diagnostic and treatment status.
RESULTS
Greater reductions were found in self-reported negative parenting behaviors and observed negative affect and greater increases in self-reported positive parenting behaviors and observed positive affect among the caregivers in the treatment group. Increases in the overall positivity of the observed interactional style of caregivers, but no observed parenting behavior change was found following treatment. Discrepancies between self-reported and observed parenting were greater among caregivers on the waitlist.
CONCLUSIONS
Following PCIT-ED treatment, caregivers self-reported improvements in parenting practices and declines in punitive practices along with observed increases in positive affect and decreases in negative affect when interacting with their child. Moreover, coherence between self-reported and observed parenting was higher in the treatment group. These findings highlight the efficacy of PCIT-ED in improving parenting behaviors and the need to use multiple methods to assess parenting in treatment studies.",2020,"RESULTS
Greater reductions were found in self-reported negative parenting behaviors and observed negative affect and greater increases in self-reported positive parenting behaviors and observed positive affect among the caregivers in the treatment group.","['early childhood depression, Parent-Child Interaction Therapy Emotion Development (PCIT-ED', 'preschool depression', '229 caregiver-child dyads, 114 randomly assigned to PCIT-ED for preschool-onset depression, and 115 assigned to a']","['waitlist completed two structured interaction tasks at baseline and post-treatment', 'PCIT-ED', 'parent-child interaction therapy']","['self-reported positive parenting behaviors', 'coherence between self-reported and observed parenting', 'parenting behaviors', 'negative parenting behaviors', 'parenting behavior change']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",229.0,0.0498308,"RESULTS
Greater reductions were found in self-reported negative parenting behaviors and observed negative affect and greater increases in self-reported positive parenting behaviors and observed positive affect among the caregivers in the treatment group.","[{'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13263']
3117,32464082,Comparison of the Effects of Two Cochlear Implant Fine Structure Coding Strategies on Speech Perception.,"Purpose This study aims to investigate the effect of upgrading from the fine structure processing (FSP) coding strategy to the novel fine structure strategy ""FS4"" in adults in adults with cochlear implants manufactured by MED-EL GmbH (Innsbruck, Austria). Method A crossover, double-blinded study was conducted for 12 weeks. Twelve adult participants were randomly assigned to two groups. During the first 6-week test interval, one group continued to use their everyday FSP strategy, whereas the other group was upgraded to the FS4 strategy. In the second 6-week interval, the two groups switched coding strategies. Speech perception was measured at the end of each test interval with the Oldenburg Sentence Test and the Göttingen Sentence Test. Participants completed the Speech, Spatial and Qualities of Hearing Scale at the end of each test interval and a simple preference test at the end of the study. Results There was no significant difference in speech perception test results obtained with the Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise. Participants' Speech, Spatial and Qualities of Hearing Scale self-evaluation and preference test results showed that the two coding strategies had similar effects on their hearing perception. No clear preference for either of the strategies was found. Conclusions Speech perception test results and the participants' level of satisfaction were similar for the two FS coding strategies. Despite differences in the presentation of temporal fine structure between FSP and FS4, a clear benefit of the newer FS4 strategy could not be shown.",2020,"There was no significant difference in speech perception test results obtained with the Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise.","['adults in adults with cochlear implants manufactured by MED-EL GmbH (Innsbruck, Austria', 'Twelve adult participants']","['fine structure processing (FSP', 'Two Cochlear Implant Fine Structure Coding Strategies']","['Speech Perception', 'speech perception test', 'Speech perception', 'Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise', 'Speech, Spatial and Qualities of Hearing Scale', 'hearing perception']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}]","[{'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]",12.0,0.0209095,"There was no significant difference in speech perception test results obtained with the Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise.","[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Heinz Dieter', 'Initials': 'HD', 'LastName': 'Klünter', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Fürstenberg', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walger', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lang-Roth', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}]",American journal of audiology,['10.1044/2020_AJA-19-00110']
3118,32464435,Comparison of parasacral transcutaneous electrical stimulation and transcutaneous posterior tibial nerve stimulation in women with overactive bladder syndrome: A randomized clinical trial.,"OBJECTIVE
To compare the effects of parasacral transcutaneous electrical stimulation with the effects of transcutaneous posterior tibial nerve stimulation in women with overactive bladder syndrome (OAB).
STUDYDESIGN
A randomized clinical trial was performed with 50 women aged 40-76 years with symptoms of OAB, divided into two groups: the parasacral transcutaneous electrical stimulation (PS) group and the transcutaneous posterior tibial nerve stimulation (PTN) group. Both groups underwent the same protocol, at home, for 6 weeks, applying electrical stimulation three times per week. The tools used for evaluation were the King's Health Questionnaire (KHQ), the Overactive Bladder-Validated 8-question Awareness Tool (OAB-V8) and the Incontinence Severity Index (ISI). Statistical analysis was undertaken using independent t-test, Mann-Whitney test, Chi-squared test and generalized estimating equations.
RESULTS
After 6 weeks of treatment, OAB-V8 showed a significant improvement in the PTN group compared with the PS group (Mann-Whitney test, p = 0.019). Post-intervention, no between-group differences were seen in terms of KHQ domains, average KHQ symptom scale and proportions of categories of ISI. All variables showed a significant effect of time after 6 weeks of treatment for both groups (p < 0.005).
CONCLUSION
Both forms of transcutaneous electrical stimulation seem to be effective and safe for home treatment of women with OAB.",2020,"Post-intervention, no between-group differences were seen in terms of KHQ domains, average KHQ symptom scale and proportions of categories of ISI.","['women with overactive bladder syndrome (OAB', 'women with overactive bladder syndrome', '50 women aged 40-76 years with symptoms of OAB', 'women with OAB']","['transcutaneous electrical stimulation', 'parasacral transcutaneous electrical stimulation and transcutaneous posterior tibial nerve stimulation', 'transcutaneous posterior tibial nerve stimulation', 'parasacral transcutaneous electrical stimulation', 'parasacral transcutaneous electrical stimulation (PS) group and the transcutaneous posterior tibial nerve stimulation (PTN) group']","[""King's Health Questionnaire (KHQ), the Overactive Bladder-Validated 8-question Awareness Tool (OAB-V8) and the Incontinence Severity Index (ISI"", 'KHQ domains, average KHQ symptom scale and proportions of categories of ISI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",50.0,0.0432647,"Post-intervention, no between-group differences were seen in terms of KHQ domains, average KHQ symptom scale and proportions of categories of ISI.","[{'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Mallmann', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: suzana_mallmann@hotmail.com.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Ferla', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Marina P', 'Initials': 'MP', 'LastName': 'Rodrigues', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luciana L', 'Initials': 'LL', 'LastName': 'Paiva', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Paulo R S', 'Initials': 'PRS', 'LastName': 'Sanches', 'Affiliation': 'Research and Development Service in Biomedical Engineering, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Ferreira', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'José Geraldo L', 'Initials': 'JGL', 'LastName': 'Ramos', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Faculty of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.005']
3119,32464489,"Effects of transcranial direct current stimulation using miniaturized devices vs sertraline for depression in Korea: A 6 week, multicenter, randomized, double blind, active-controlled study.","We compared the efficacy and safety of transcranial direct current stimulation (tDCS) vs. Sertraline in the treatment of Major Depressive Disorder (MDD) in South Korean participants. This was a multi-center, double blind, active controlled study with non-inferiority testing. Patients were randomly assigned to receive tDCS (n = 45) or Sertraline (n = 47). tDCS was administered in 30-min, 2 mA prefrontal stimulation sessions for 10 consecutive weekdays, followed by 2 treatments at 4 and 6 weeks. Sertraline was administered at a dose of 50 mg per day for 6 weeks. The primary outcome measure was a change in the Montgomery-Asberg Depression Rating Scale (MADRS) score at six weeks. Mean MADRS scores decreased by 14.58 ± 8.51 points in the tDCS group and 12.32 ± 8.56 points in the Sertraline group. There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539). Noninferiority of tDCS compared with Sertraline was not demonstrated. The mean difference between the Sertraline and tDCS group was -2.258 (95% confidence interval [CI], -5.795 to 1.27811), and the lower boundary of the CI was lower than the prespecified noninferiority margin of -3.56. There were no significant group differences in the rate of adverse events. In the present study, the noninferiority of tDCS to Sertraline for the treatment of depression was not found in this Korean population.",2020,"There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539).","['depression in Korea', 'Major Depressive Disorder (MDD) in South Korean participants']","['Sertraline', 'tDCS', 'transcranial direct current stimulation (tDCS) vs. Sertraline', 'transcranial direct current stimulation using miniaturized devices vs sertraline']","['efficacy and safety', 'change in the Montgomery-Asberg Depression Rating Scale (MADRS) score', 'Mean MADRS scores', 'rate of adverse events']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.365678,"There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539).","[{'ForeName': 'Sunyoung', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, National Health Insurance Corporation Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Won-Jung', 'Initials': 'WJ', 'LastName': 'Choi', 'Affiliation': 'Gangnam Yonsei Psychiatry Clinic, Seoul, South Korea; Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sejoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Borah', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Son', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Daeyoung', 'Initials': 'D', 'LastName': 'Roh', 'Affiliation': 'Mind-neuromodulation Laboratory and Department of Psychiatry, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Woo Jung', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Gyeonggi, South Korea; Center for Digital Health, Yongin Severance Hospital, Yonsei University Health System, Yongin, Gyeonggi, South Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Gyeonggi, South Korea; Center for Digital Health, Yongin Severance Hospital, Yonsei University Health System, Yongin, Gyeonggi, South Korea. Electronic address: EMPATHY@yuhs.ac.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.012']
3120,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES
Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN
The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.
MAIN OUTCOME MEASURES
20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS
15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).
INTERPRETATION
As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.
FUNDING
The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006']
3121,32464566,"Efficacy of the computer simulation-based, interactive communication education program for nursing students.","BACKGROUND
Simulation-based education using standardized patients or high fidelity patient simulators is resource-intensive and can be limited in its consistency and repeatability. Standardized, interactive, and effective computer simulation-based education programs that improve communication skills among nursing students are greatly needed.
OBJECTIVES
This study aimed to (1) compare the efficacy of a computer simulation-based, interactive communication education (ComEd) program and an attention control (AC) program on communication knowledge, learning self-efficacy, and communication efficacy at baseline and twice after the intervention (immediately after and two weeks after); and (2) assess the acceptability and satisfaction of the ComEd reported by the participants.
DESIGN
This study employed a mixed-method, randomized controlled design with repeated measures.
METHODS
Students were recruited from four nursing schools and randomly assigned to either the intervention or AC group. They received either the ComEd or AC program installed on a tablet PC or a desktop computer in the classrooms and completed a 15-item communication knowledge scale, 10-item learning self-efficacy scale, 22-item communication efficacy scale, and 14-item satisfaction scale. In addition, six open-ended questions were used to help participants reflect on their learning experiences and explore their satisfaction with the programs. The Generalized Estimating Equation (GEE) model was the main model employed to examine the effects of the ComEd program over time in comparison with the AC program, and the content analysis method was used for qualitative data.
RESULTS
In total, 131 nursing students (66 in ComEd and 65 in AC) completed the programs and 127 participated through the two-week follow-up test. Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks. The ComEd program was well accepted by the participants.
CONCLUSIONS
The ComEd is a promising approach because it is highly accessible, consistent, and repeatable, and has positive learning effects.",2020,"Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks.","['131 nursing students (66 in ComEd and 65 in AC) completed the programs and 127 participated through the two-week follow-up test', 'nursing students', 'Students were recruited from four nursing schools']","['computer simulation-based, interactive communication education (ComEd) program and an attention control (AC) program', 'computer simulation-based, interactive communication education program']","['communication skills', 'communication knowledge, learning self-efficacy, and communication efficacy', 'acceptability and satisfaction', '15-item communication knowledge scale, 10-item learning self-efficacy scale, 22-item communication efficacy scale, and 14-item satisfaction scale']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036380', 'cui_str': 'Nursing Schools'}]","[{'cui': 'C0009609', 'cui_str': 'Models, Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",131.0,0.0254637,"Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks.","[{'ForeName': 'Heeseung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea; College of Nursing & The Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea. Electronic address: hchoi20@snu.ac.kr.'}, {'ForeName': 'Ujin', 'Initials': 'U', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Ye Seul', 'Initials': 'YS', 'LastName': 'Jeon', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Dong-A University, Busan, Republic of Korea.'}]",Nurse education today,['10.1016/j.nedt.2020.104467']
3122,32472012,The effectiveness of quick starting oral contraception containing nomegestrol acetate and 17-β estradiol on ovulation inhibition: A randomized controlled trial.,"To determine the effectiveness of quick starting combined oral contraception (COC) contain 2.5 mg nomegestrol acetate and 1.5 mg estradiol (NOMAC/E2) comparing with 0.075 mg gestodene and 0.02 mg ethinyl estradiol (GS/EE) on ovarian ovulation inhibition rate, we conducted a non-inferiority randomized controlled trial involving 69 healthy female volunteers aged 18-40 years who had normal menstrual history and were randomized at a 2:1 ratio to take one pack of COC containing either NOMAC/E2 (study group) or GS/EE (control group) starting on menstrual cycle Day7-9. The ovarian activity was assessed by using Hoogland and Skouby grading. Forty-six and 23 participants were randomized to NOMAC/E2 and GS/EE groups, respectively. Baseline characteristics were similar between groups. No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000). Quick starting COC during day7-9 of menstrual cycle can inhibit ovulation for more than 90%. The quick starting NOMAC/E2 is non-inferior to GS/EE for preventing ovulation and suppressing follicular growth.",2020,"No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000).","['69 healthy female volunteers aged 18-40 years who had normal menstrual history', 'Forty-six and 23 participants']","['nomegestrol acetate and 17-β estradiol', 'NOMAC/E2 and GS/EE', 'gestodene and 0.02\u2009mg ethinyl estradiol (GS/EE', 'quick starting combined oral contraception (COC) contain 2.5\u2009mg nomegestrol acetate and 1.5\u2009mg estradiol (NOMAC/E2', 'COC containing either NOMAC/E2 (study group) or GS/EE (control group) starting on menstrual cycle Day7-9']","['ovarian ovulation inhibition rate', 'ovulation rate', 'ovarian quiescence rate', 'ovulation inhibition rate', 'persistent cyst rate', 'ovulation inhibition', 'ovarian activity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0019664', 'cui_str': 'History'}]","[{'cui': 'C0132749', 'cui_str': 'Nomegestrol acetate'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0061246', 'cui_str': 'Gestodene'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}]","[{'cui': 'C0029968', 'cui_str': 'Ovulation Suppression'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",69.0,0.249135,"No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000).","[{'ForeName': 'Preeyaporn', 'Initials': 'P', 'LastName': 'Jirakittidul', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. preeyajira@hotmail.com.'}, {'ForeName': 'Surasak', 'Initials': 'S', 'LastName': 'Angsuwathana', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Manee', 'Initials': 'M', 'LastName': 'Rattanachaiyanont', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thunyada', 'Initials': 'T', 'LastName': 'Thiampong', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chanon', 'Initials': 'C', 'LastName': 'Neungton', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Benjaphorn', 'Initials': 'B', 'LastName': 'Chotrungrote', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Scientific reports,['10.1038/s41598-020-65642-5']
3123,32472048,Efficacy of conbercept combined with panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.,"This prospective clinical study was to compare the effect of panretinal photocoagulation (PRP) associated with intravitreal conbercept injections versus PRP alone in the treatment of proliferative diabetic retinopathy (PDR). For each of 15 patients included, one eye was randomly assigned to receive treatment with PRP, and the other eye received conbercept combined PRP. Ophthalmic examinations, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) were performed at baseline and at each monthly visit until 6 months. Fluorescein angiography (FA) was acquired at baseline, 3 months and 6 months. Between group and within group analysis was done by using generalized estimating equations (GEE). The combination group had a significant decrease of neovascularization (NV) leakage area than the PRP group at month 3 and month 6 after treatment, and a better best-corrected visual acuity (BCVA) during the first three months. Within-group analysis indicated a significant decrease in NV leakage at month 3 and month 6 in both groups, and a significant increase in BCVA at 1 month in the combination group. In summary, the combination of intravitreal injection of conbercept and PRP can significantly reduce the NV of PDR patients and achieve better BCVA during the drug's lifespan compared with PRP alone.",2020,"The combination group had a significant decrease of neovascularization (NV) leakage area than the PRP group at month 3 and month 6 after treatment, and a better best-corrected visual acuity (BCVA) during the first three months.","['proliferative diabetic retinopathy', '15 patients included, one eye', 'proliferative diabetic retinopathy (PDR']","['PRP', 'conbercept combined with panretinal photocoagulation', 'panretinal photocoagulation (PRP', 'Fluorescein angiography (FA', 'intravitreal conbercept injections versus PRP alone', 'Ophthalmic examinations, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA', 'conbercept combined PRP']","['NV leakage', 'better best-corrected visual acuity (BCVA', 'BCVA', 'neovascularization (NV) leakage area']","[{'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0268657,"The combination group had a significant decrease of neovascularization (NV) leakage area than the PRP group at month 3 and month 6 after treatment, and a better best-corrected visual acuity (BCVA) during the first three months.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Division of Statistics, School of Economics, Shanghai University, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China. yuweihongeye@foxmail.com.'}]",Scientific reports,['10.1038/s41598-020-65833-0']
3124,32472075,Two nights of recovery sleep restores hippocampal connectivity but not episodic memory after total sleep deprivation.,"Sleep deprivation significantly impairs a range of cognitive and brain function, particularly episodic memory and the underlying hippocampal function. However, it remains controversial whether one or two nights of recovery sleep following sleep deprivation fully restores brain and cognitive function. In this study, we used functional magnetic resonance imaging (fMRI) and examined the effects of two consecutive nights (20-hour time-in-bed) of recovery sleep on resting-state hippocampal connectivity and episodic memory deficits following one night of total sleep deprivation (TSD) in 39 healthy adults in a controlled in-laboratory protocol. TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity. Following TSD, two nights of recovery sleep restored hippocampal connectivity to baseline levels, but did not fully restore memory performance nor its associations with hippocampal connectivity. These findings suggest that more than two nights of recovery sleep are needed to fully restore memory function and hippocampal-memory associations after one night of total sleep loss.",2020,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.",['39 healthy adults in a controlled in-laboratory protocol'],"['two consecutive nights (20-hour time-in-bed) of recovery sleep', 'total sleep deprivation (TSD', 'TSD', 'functional magnetic resonance imaging (fMRI']","['hippocampal connectivity to multiple prefrontal and default mode network regions', 'Sleep deprivation', 'memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",39.0,0.0326211,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Fan Nils', 'Initials': 'FN', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Sihua', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Raine', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jieqiong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Meichen', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Basner', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Junghoon J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular, Cellular, and Biomedical Sciences, CUNY School of Medicine, The City College of New York, New York, NY, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wolk', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Detre', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Hengyi', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA. hengyi@pennmedicine.upenn.edu.'}]",Scientific reports,['10.1038/s41598-020-65086-x']
3125,32472363,Role of Aspirin for Primary Prevention in Persons with Diabetes Mellitus and in the Elderly.,"PURPOSE OF REVIEW
To review the clinical evidence of the effect of aspirin as primary prevention for patients with diabetes mellitus and in healthy elderly.
RECENT FINDINGS
Two trials were performed to study these two patient populations: ASCEND showed that the use of low-dose aspirin in persons with diabetes, who did not have prior cardiovascular disease, led to a lower risk of cardiovascular events than placebo (8.5% vs 9.6%, rate ratio 0.88, 95% CI 0.79-0.97; p = 0.01). However, it showed a similar magnitude of increased risk of major bleeding among the aspirin group compared with placebo (4.1% vs 3.2%, rate ratio 1.29, 95% CI 1.09-1.52; p = 0.003). ASPREE showed that the use of low-dose aspirin in healthy elderly did not prolong disability-free survival (21.5% vs 21.2%, HR 1.01, 95% CI 0.92-1.11; p = 0.79); however, the rate of major hemorrhage was higher in the aspirin group than in the placebo group (3.8% vs 2.8%, HR 1.38, 95% CI 1.18-1.62; p < 0.001). Additionally, further analyses of secondary end points of death, cardiovascular disease, and major hemorrhage were also studied. Higher all-cause mortality was seen among healthy elderly who received aspirin compared with placebo (12.7% vs 11.1%, HR 1.14, 95% CI 1.01-1.29) and was primarily attributed to cancer-related deaths. Similar risk of cardiovascular disease was seen among elderly who received aspirin compared with placebo (10.7% vs 11.3%, HR 0.95, 95% CI 0.83-1.08) and resulted in a significantly higher risk of major hemorrhage (8.6% vs 6.8%, HR 1.38, 95% CI 1.18-1.62; p < 0.001). These studies show that the use of low-dose aspirin as primary prevention in patients with diabetes and in the elderly does not have overall beneficial effect compared with its use in secondary prevention. In patients with diabetes without prior cardiovascular disease, the benefits of aspirin use were counterbalanced by the bleeding risk. Additionally, in healthy elderly, the use of aspirin did not prolong disability-free survival and instead led to a higher rate of major hemorrhage.",2020,"Higher all-cause mortality was seen among healthy elderly who received aspirin compared with placebo (12.7% vs 11.1%, HR 1.14, 95% CI 1.01-1.29) and was primarily attributed to cancer-related deaths.","['patients with diabetes mellitus and in healthy elderly', 'Persons with Diabetes Mellitus and in the Elderly', 'patients with diabetes', 'patients with diabetes without prior cardiovascular disease']","['placebo', 'Aspirin', 'aspirin']","['death, cardiovascular disease, and major hemorrhage', 'risk of major bleeding', 'risk of major hemorrhage', 'rate of major hemorrhage', 'disability-free survival', 'Similar risk of cardiovascular disease', 'cause mortality', 'risk of cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.173039,"Higher all-cause mortality was seen among healthy elderly who received aspirin compared with placebo (12.7% vs 11.1%, HR 1.14, 95% CI 1.01-1.29) and was primarily attributed to cancer-related deaths.","[{'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Patel', 'Affiliation': 'University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Ragavendra R', 'Initials': 'RR', 'LastName': 'Baliga', 'Affiliation': 'The Ohio State University Medical Center, Columbus, OH, USA. rrbaliga@gmail.com.'}]",Current cardiology reports,['10.1007/s11886-020-01296-z']
3126,32469811,Endogenous cortisol-related alterations of right anterior insula functional connectivity under acute stress.,"BACKGROUND
Previous studies have suggested that the right anterior insula (rAI) plays a vital role in salience processing and stress-related disorders. In this study, we aimed to investigate the relationship between rAI functional connectivity changes and individual differences in cortisol responses after acute stress, in order to provide insights into psychiatric illness vulnerabilities.
METHODS
Thirty-five young men were enrolled in a randomized, counterbalanced two-session study, with aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation. Resting-state fMRI data was acquired after movie exposure. The rAI was chosen as seed for functional connectivity analysis. We then examined the effect of acute stress on rAI functional connectivity and its association with individuals' cortisol response.
RESULTS
We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress. Moreover, stress-induced cortisol response was significantly positively correlated with the rAI functional connectivity in the medial prefrontal cortex, and negatively correlated with the orbital-frontal cortex, lingual gyrus, and middle temporal gyrus.
LIMITATIONS
Only young Chinese males without any trauma experience were recruited in this study.
CONCLUSIONS
The results suggested tight link between specific rAI functional connectivity alterations and individual stress reactivity, which may help elucidate the potential neurobiological mechanism underlying vulnerability to stress-related disorders.",2020,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","['Only young Chinese males without any trauma experience', 'Thirty-five young men']",['aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation'],"['stress-induced cortisol response', 'orbital-frontal cortex, lingual gyrus, and middle temporal gyrus', 'functional connectivity', 'rAI functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",35.0,0.0233179,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China; Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Yituo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Seventh Medical Center of the Chinese PLA General Hospital, Beijing, 100700, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Lubin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: wanglb@bmi.ac.cn.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: xjhu2003@vip.sina.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.123']
3127,32469819,Short and Long-Term Effects of Cannabis on Symptoms of Post-Traumatic Stress Disorder.,"BACKGROUND
Many individuals use cannabis to manage symptoms of post-traumatic stress disorder (PTSD), and evidence indicates that the endocannabinoid system represents a viable target for treating these symptoms.
METHOD
Data from 404 medical cannabis users who self-identified as having PTSD were obtained from Strainprint®, a medical cannabis app that patients use to track changes in symptoms as a function of different strains and doses of cannabis across time. This sample collectively used the app 11,797 times over 31 months to track PTSD-related symptoms (intrusive thoughts, flashbacks, irritability, and/or anxiety) immediately before and after inhaling cannabis. Latent change score models were used to examine changes in symptom severity and predictors of these changes (gender, dose, cannabis constituents, time). Multilevel models were used to explore long-term consequences of repeatedly using cannabis to manage these symptoms.
RESULTS
All symptoms were reduced by more than 50% immediately after cannabis use. Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions. Higher doses of cannabis predicted larger reductions in intrusions and anxiety, and dose used to treat anxiety increased over time. Baseline severity of all symptoms remained constant across time.
LIMITATIONS
The sample was self-selected, self-identified as having PTSD, and there was no placebo control group.
CONCLUSIONS
Cannabis provides temporary relief from PTSD-related symptoms. However, it may not be an effective long-term remedy as baseline symptoms were maintained over time and dose used for anxiety increased over time, which is indicative of development of tolerance.",2020,"Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions.","['Data from 404 medical cannabis users who self-identified as having PTSD were obtained from Strainprint®, a medical cannabis app that patients use to track changes in symptoms as a function of different strains and doses of cannabis across time']",['Cannabis'],"['intrusions and irritability', 'symptom relief', 'intrusions and anxiety, and dose used to treat anxiety', 'symptoms (intrusive thoughts, flashbacks, irritability, and/or anxiety']","[{'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0558066', 'cui_str': 'Intrusive thoughts'}, {'cui': 'C0236720', 'cui_str': 'Flashbacks'}]",,0.0308863,"Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions.","[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Glodosky', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bonn-Miller', 'Affiliation': 'The University of Pennsylvania Perelman School of Medicine, Department of Psychiatry, 3535 Market Street, Suite 500, Philadelphia, PA 19104.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.132']
3128,32469835,"The effectiveness of modified, group-based CBT for dementia worry among Chinese elders.","OBJECTIVES
Dementias are highly prevalent among Chinese elders. This study examined the effectiveness of a modified group cognitive behavioral therapy (CBT) on dementia worry among Chinese older adults.
METHODS
Eighty-two older adults recruited from four elder group homes were randomly assigned to either intervention or control group. The intervention group (n= 44) received eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual.
RESULTS
Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001). Study findings supported both statistically and clinically significant effect of modified group CBT on dementia worry [g=-1.52, 95% CI (-2.01, -1.03)] and biased beliefs about dementia [g=-.95, 95% CI (-1.40, -.49)].
DISCUSSION
The culturally adapted CBT is promising in alleviating worries and anxiety over dementia among Chinese older adults. Future research needs to include larger samples and participants from different regions to replicate findings.",2020,"RESULTS
Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","['Eighty-two older adults recruited from four elder group homes', 'Chinese elders', 'Chinese older adults']","['eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual', 'modified, group-based CBT', 'modified group cognitive behavioral therapy (CBT']","['dementia worry', 'dementia worry and culturally biased beliefs about dementia']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018257', 'cui_str': 'Group Homes'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",82.0,0.0313174,"RESULTS
Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","[{'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'An', 'Affiliation': 'East China Normal University, School of Social Development, 500 DongChuan Rd., Shanghai, China.'}, {'ForeName': 'Kaipeng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'University of Denver, Graduate School of Social Work, Denver, CO, USA. Electronic address: Kaipeng.Wang@du.edu.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI, USA.'}, {'ForeName': 'Anao', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'University of Michigan, School of Social Work, Ann Arbor, MI, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.054']
3129,32469838,"Repeated transcranial direct current stimulation of dorsolateral-prefrontal cortex improves executive functions, cognitive reappraisal emotion regulation, and control over emotional processing in borderline personality disorder: A randomized, sham-controlled, parallel-group study.","BACKGROUND
Borderline personality disorder (BPD) is primarily characterized by deficient emotion regulation. Impaired cognitive control over negative emotions is central to emotion dysregulation in BPD. Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality. Here, we investigated the effect of increasing activity of the dorsolateral prefrontal cortex (DLPFC) with repeated transcranial direct current stimulation (tDCS) on (1) executive dysfunctions and (2) whether improving cognitive control affects emotion dysregulation and emotional processing in BPD.
METHODS
Thirty-two patients diagnosed with BPD were randomly assigned to active stimulation (N = 16) or sham stimulation (N = 16) group in a randomized, sham-controlled, parallel-group design. They received 10 sessions of active (2 mA, 20 min, anodal left- cathodal right DLPFC) or sham tDCS over 10 days. Major executive functions, emotion regulation strategies, and emotional processing of the patients were assessed before and immediately after the intervention.
RESULTS
The active stimulation group showed a significant improvement in major executive function domains. Importantly, cognitive reappraisal strategy of emotion regulation and several factors of emotional processing involved in the control of emotion significantly improved in the active stimulation group after the intervention. Factors related to emotional expression were, however, not affected.
LIMITATIONS
The single-blind design, absence of follow-up measures, and the intrinsically limited focality of tDCS are limitations of this study.
CONCLUSIONS
Increasing activity of the DLPFC improves executive functioning in BPD and improves ´cognitive control over negative emotions. Cognitive control interventions could be a potential, symptom-driven therapeutic approach in BPD.",2020,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","['borderline personality disorder', 'Thirty-two patients diagnosed with BPD', 'Borderline personality disorder (BPD']","['10 sessions of active (2\xa0mA, 20\xa0min, anodal left', 'repeated transcranial direct current stimulation (tDCS', 'cathodal right DLPFC) or sham tDCS', 'Cognitive control interventions', 'transcranial direct current stimulation of dorsolateral-prefrontal cortex', 'active stimulation (N\xa0=\xa016) or sham stimulation']","['emotional expression', 'major executive function domains', 'Major executive functions, emotion regulation strategies, and emotional processing', 'executive functions, cognitive reappraisal emotion regulation']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",32.0,0.096733,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","[{'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Molavi', 'Affiliation': 'Department of Psychiatry, Fatemi Hospital, School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Aziziaram', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Basharpoor', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: basharpoor_sajjad@uma.ac.ir.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Atadokht', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany. Electronic address: salehinejad@ifado.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.007']
3130,32475705,The risk of developing disordered eating following a family-based program among children with overweight and obesity and their siblings: Retrospective and prospective analyses.,"BACKGROUND
Studies have raised the concern that dieting and weight-loss programs may be a potential risk factor for developing eating disorders, and may have a potential to affect siblings as well. This study assessed the long-term risk of developing disordered eating among children with overweight and obesity and their siblings as well as the change in the obesogenic environment following a family-based intervention program.
METHODS
In a 30-month retrospective follow-up study (n=18 families in intervention group, n=26 families in control group, total of 81 children and siblings) and a 14-month prospective follow-up study (n=42 families, 78 children and siblings), families with one or more children with overweight or obesity ages 8-14 years participated in a multidisciplinary parent-child program called ""Maccabi Active"". Children's version of the eating-attitude-test (ChEAT) questionnaire, family eating-and-activity-habits questionnaire (FEAHQ) and BMI z-score were measured.
RESULTS
in the retrospective study, no difference between groups with respect to ChEAT scores in children and siblings was found. In the prospective study, the FEAHQ score significantly decreased after completion of the program (ΔFEAHQ=-16.2±4.9, p=0.001) and continued to decrease in the 8-month follow-up (ΔFEAHQ=-23.2±5.7, p=0.001). BMI z-scores decreased after 6 months (ΔBMI z-score=-0.3±0.1, p=0.014), and did not increase in the 8-month follow-up.
CONCLUSIONS
Our findings suggest no exacerbation in disordered eating behaviors among children with overweight or obesity or their siblings, thus alleviating concerns surrounding the development of disordered eating after participating in a family-based intervention. Moreover, improvement in obesogenic environment suggests potential benefits to the entire family.",2020,"BMI z-scores decreased after 6 months (ΔBMI z-score=-0.3±0.1, p=0.014), and did not increase in the 8-month follow-up.
","['n=18 families in intervention group, n=26 families in control group, total of 81 children and siblings) and a 14-month prospective follow-up study (n=42 families, 78 children and siblings), families with one or more children with overweight or obesity ages 8-14 years participated in a', 'children with overweight or obesity or their siblings', 'children with overweight and obesity and their siblings']","['multidisciplinary parent-child program called ""Maccabi Active']","['FEAHQ score', 'BMI z-scores', ""Children's version of the eating-attitude-test (ChEAT) questionnaire, family eating-and-activity-habits questionnaire (FEAHQ) and BMI z-score"", 'disordered eating behaviors']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451136', 'cui_str': 'Eating attitudes test'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",81.0,0.0161907,"BMI z-scores decreased after 6 months (ΔBMI z-score=-0.3±0.1, p=0.014), and did not increase in the 8-month follow-up.
","[{'ForeName': 'Batya', 'Initials': 'B', 'LastName': 'Shaharabany', 'Affiliation': 'Department of Nutritional Sciences, Tel-Hai College, Upper Galilee, Israel; Maccabi Health Care Services, Northern District, Haifa, Israel. Electronic address: batya496@gmail.com.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Tepper', 'Affiliation': 'Department of Nutritional Sciences, Tel-Hai College, Upper Galilee, Israel. Electronic address: sigalt@bgu.ac.il.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'Maccabi Health Care Services, Northern District, Haifa, Israel. Electronic address: Berman_s@mac.org.il.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Golan', 'Affiliation': 'Department of Nutritional Sciences, Tel-Hai College, Upper Galilee, Israel. Electronic address: moria.golan@mail.huji.ac.il.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.04.007']
3131,32475771,"Corrigendum to ""Effect of patient education on palliative care knowledge and acceptability of outpatient palliative care services among gynecologic oncology patients: A randomized controlled trial"" [Gynecol. Oncol. 156 (2020) 482-487].",,2020,,"['156 (2020', 'gynecologic oncology patients']",[],[],"[{'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0849144,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Graul', 'Affiliation': ""Department of Gynecologic Oncology, St. Luke's University Health System, Bethlehem, PA, United States of America. Electronic address: Ashley.graul@sluhn.org.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Haggerty', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stickley', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Palliative Care, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bogner', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ko', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.015']
3132,32475836,Improved diabetes control among low-income Mexican Americans through community-clinical interventions: results of an RCT.,"INTRODUCTION
This randomized controlled trial investigated community-clinical intervention strategies for a Mexican American population who had not demonstrated control of their diabetes. We tested a control program (Salud y Vida 1.0) supporting diabetes management versus an enhanced version (Salud y Vida 2.0) for reductions in HbA1c at 12 months.
RESEARCH DESIGN AND METHODS
Adults with uncontrolled diabetes (n=353) were enrolled if they had an HbA1c≥9.0% during a program or doctor's visit between 6 and 36 months of their receipt of SyV 1.0 services, were patients at one of two clinics in local counties, and had an HbA1c≥8.0% at SyV 2.0 baseline enrollment. The control and intervention arms were coordinated by community health workers and the intervention arm included the control program enhanced with medication therapy management; behavioral health services; peer-led support groups; and additional community-based lifestyle programs also open to the family.
RESULTS
At 12 months, both study arms improved HbA1c (mean, (CI), Control (-0.47 (-0.74 to -0.20)) and intervention (-0.48 (-0.76 to -0.19)). The intervention group maintained HbA1c levels after month 6, whereas control group HbA1c levels slightly increased (adjusted mean from 9.83% at month 6%-9.90% at month 12). Also, HbA1c was examined by level of participant engagement. The high engagement group showed a decreasing trend over the study period, while control and lower engagement groups failed to maintain HbA1c levels at month 12.
CONCLUSIONS
Improved HbA1c was found among a population that had not demonstrated diabetes management prior; however, mean HbA1c values were above clinical guideline recommendations. The randomized control trial findings provide additional evidence that extended time and intervention supports may be needed for populations experiencing inequities in social determinants of health.
TRIAL REGISTRATION NUMBER
NCT04035395.",2020,"At 12 months, both study arms improved HbA1c (mean, (CI), Control (-0.47 (-0.74 to -0.20)) and intervention (-0.48 (-0.76 to -0.19)).","[""Adults with uncontrolled diabetes (n=353) were enrolled if they had an HbA1c≥9.0% during a program or doctor's visit between 6 and 36 months of their receipt of SyV 1.0 services, were patients at one of two clinics in local counties, and had an HbA1c≥8.0% at SyV 2.0 baseline enrollment"", 'Mexican American population who had not demonstrated control of their diabetes']","['community health workers and the intervention arm included the control program enhanced with medication therapy management; behavioral health services; peer-led support groups; and additional community-based lifestyle programs also open to the family', 'control program (Salud y Vida 1.0) supporting diabetes management versus an enhanced version']","['HbA1c (mean, (CI), Control', 'maintain HbA1c levels', 'HbA1c levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",353.0,0.0442403,"At 12 months, both study arms improved HbA1c (mean, (CI), Control (-0.47 (-0.74 to -0.20)) and intervention (-0.48 (-0.76 to -0.19)).","[{'ForeName': 'Belinda M', 'Initials': 'BM', 'LastName': 'Reininger', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA Belinda.M.Reininger@uth.tmc.edu.'}, {'ForeName': 'MinJae', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Manouchehr', 'Initials': 'M', 'LastName': 'Hessabi', 'Affiliation': 'Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mitchell-Bennett', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA.'}, {'ForeName': 'Maribel R', 'Initials': 'MR', 'LastName': 'Sifuentes', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Guerra', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA.'}, {'ForeName': 'Ciara D', 'Initials': 'CD', 'LastName': 'Ayala', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA.'}, {'ForeName': 'Tianlin', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Polletta', 'Affiliation': 'Research and Evaluation, Health Resources in Action, Inc, Boston, Massachusetts, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Research and Evaluation, Health Resources in Action, Inc, Boston, Massachusetts, USA.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Rahbar', 'Affiliation': 'Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000867']
3133,32475838,"Long-term changes in carbohydrate tolerance, insulin secretion and action in African-American patients with obesity and history of hyperglycemic crises.","INTRODUCTION
Many African-Americans (AA) with obesity with newly diagnosed diabetes presenting with diabetic ketoacidosis (DKA) or severe hyperglycemia (SH) discontinue insulin therapy and achieve near-normoglycemia remission (hemoglobin A1c (HbA1c) <7%, fasting blood glucose (FBG) <130 mg/dL) and able to be managed on oral antidiabetic agents (OAD) during follow-up. Using combined data from two randomized controlled trials, we assessed long-term carbohydrate tolerance and changes in insulin sensitivity and insulin secretion.
RESEARCH DESIGN AND METHODS
Seventy-five participants with DKA (n=33) and SH (n=42) underwent 2-hour 75 g oral glucose tolerance test (OGTT) after insulin discontinuation and every 6 months until hyperglycemia relapse (FBG ≥130 mg/dL, HbA1c >7% or two random BG ≥180 mg/dL) while treated with OAD (metformin, sitagliptin or pioglitazone) or placebo. Glucose tolerance status was defined as per the American Diabetes Association. Sensitivity index (S i ) was calculated by oral minimal model, insulin secretion as the incremental area under the curve of insulin (IncreAUC i ) and disposition index (DI) as S i ×IncreAUC i .
RESULTS
During remission, OGTT showed normal glucose tolerance (NGT) (n=9 (12%)), prediabetes (n=34 (45%)) and diabetes (n=32 (43%)). DI and S i were higher in patients with NGT versus prediabetes versus diabetes (p<0.001), while IncreAUC i was not significantly different among NGT, prediabetes and diabetes (p=0.14). Achieving NGT status did not prolong near-normoglycemia remission. OAD treatment significantly prolonged hyperglycemia relapse-free survival (log-rank p=0.0012) compared with placebo and was associated with lower hyperglycemia relapse (HR: 0.45, 95% CI: (0.21 to 0.96), p=0.04).
CONCLUSIONS
In AA patients with obesity with history of DKA and SH, near-normoglycemia remission is associated with improved insulin secretion and action with half of patients achieving NGT or prediabetes, and only half having diabetes on OGTT. NGT and prediabetes on OGTT were not associated with prolonged hyperglycemia relapse-free survival.
TRIAL REGISTRATION NUMBER
NCT01099618, NCT00426413.",2020,"OAD treatment significantly prolonged hyperglycemia relapse-free survival (log-rank p=0.0012) compared with placebo and was associated with lower hyperglycemia relapse (HR: 0.45, 95% CI: (0.21 to 0.96), p=0.04).
","['African-Americans (AA) with obesity with newly diagnosed diabetes presenting with diabetic ketoacidosis (DKA) or severe hyperglycemia (SH) discontinue insulin therapy and achieve near-normoglycemia remission (hemoglobin A1c (HbA1c', 'African-American patients with obesity and history of hyperglycemic crises', 'Seventy-five participants with DKA (n=33) and SH (n=42) underwent', 'In AA patients with obesity with history of DKA and SH, near-normoglycemia remission']","['OAD (metformin, sitagliptin or pioglitazone) or placebo', '2-hour 75\u2009g oral glucose tolerance test (OGTT) after insulin discontinuation and every 6 months until hyperglycemia relapse (FBG ≥130\u2009mg/dL', 'placebo']","['incremental area under the curve of insulin (IncreAUC i ) and disposition index (DI', 'Glucose tolerance status', 'near-normoglycemia remission', 'Sensitivity index (S i ', 'DI and S i', 'prolonged hyperglycemia relapse-free survival', 'carbohydrate tolerance, insulin secretion and action', 'hyperglycemia relapse-free survival', 'fasting blood glucose (FBG', 'insulin sensitivity and insulin secretion', 'hyperglycemia relapse', 'normal glucose tolerance (NGT']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}]",75.0,0.0347916,"OAD treatment significantly prolonged hyperglycemia relapse-free survival (log-rank p=0.0012) compared with placebo and was associated with lower hyperglycemia relapse (HR: 0.45, 95% CI: (0.21 to 0.96), p=0.04).
","[{'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, Georgia, USA priyathama.vellanki@emory.edu.'}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Stefanovski', 'Affiliation': 'Department of Clinical Studies-New Bolton Center, University of Pennsylvania School of Veterinary Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Isabel I', 'Initials': 'II', 'LastName': 'Anzola', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Dawn D', 'Initials': 'DD', 'LastName': 'Smiley', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001062']
3134,32475846,Periodontal ligament proliferation and expressions of bone biomolecules upon orthodontic preloading: Clinical implications for tooth autotransplantation.,"Objective
Preservation of the periodontal ligament (PDL) is vital to the success of tooth autotransplantation (TAT). Increased PDL volumes and facilitated tooth extraction have been observed upon orthodontic preloading. However, it is unclear whether any changes occur in the expressions of bone biomolecules in the increased PDL volumes. This study aimed to determine the expressions of runt-related transcription factor 2 (RUNX2), alkaline phosphatase (ALP), receptor activator of nuclear factor kappa-B ligand (RANKL), and osteoprotegerin (OPG) in PDL upon preloading.
Methods
Seventy-two premolars from 18 patients were randomly assigned to experimental groups that received a leveling force for 1, 2, or 4 weeks or to a control unloaded group. Following extraction, PDL volumes from 32 premolars of eight patients (21.0 ± 3.8 years) were evaluated using toluidine blue staining. The expressions of the biomolecules in the PDL from 40 premolars of ten patients (21.4 ± 4.0 years) were analyzed via immunoblotting.
Results
The median percentage of stained PDL was significantly higher at 2 and 4 weeks after preloading than in the unloaded condition ( p < 0.05). The median RUNX2 and ALP expression levels were significantly higher at 2 and 4 weeks after preloading than in the unloaded condition ( p < 0.05), whereas the median RANKL/OPG ratios were significantly higher at 1 and 4 weeks after preloading ( p < 0.05).
Conclusions
Orthodontic preloading for 4 weeks enhances PDL volumes as well as the expressions of RUNX2, ALP and the RANKL/OPG ratio in the PDL, suggesting this loading period is suitable for successful TAT.",2020,"The median RUNX2 and ALP expression levels were significantly higher at 2 and 4 weeks after preloading than in the unloaded condition ( p < 0.05), whereas the median RANKL/OPG ratios were significantly higher at 1 and 4 weeks after preloading ( p < 0.05).
","['tooth autotransplantation', '40 premolars of ten patients (21.4 ± 4.0 years) were analyzed via immunoblotting', 'Methods\n\n\nSeventy-two premolars from 18 patients', '32 premolars of eight patients (21.0 ± 3.8 years) were evaluated using toluidine blue staining']",['periodontal ligament (PDL'],"['median RUNX2 and ALP expression levels', 'Increased PDL volumes', 'expressions of runt-related transcription factor 2 (RUNX2), alkaline phosphatase (ALP), receptor activator of nuclear factor kappa-B ligand (RANKL), and osteoprotegerin (OPG', 'median percentage of stained PDL', 'median RANKL/OPG ratios', 'Periodontal ligament proliferation and expressions of bone biomolecules', 'PDL volumes']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}]","[{'cui': 'C0031093', 'cui_str': 'Periodontal ligament'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1529564', 'cui_str': 'RUNX2 protein, human'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0031093', 'cui_str': 'Periodontal ligament'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0666361', 'cui_str': 'TNFSF11 protein, human'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",18.0,0.0289255,"The median RUNX2 and ALP expression levels were significantly higher at 2 and 4 weeks after preloading than in the unloaded condition ( p < 0.05), whereas the median RANKL/OPG ratios were significantly higher at 1 and 4 weeks after preloading ( p < 0.05).
","[{'ForeName': 'Sasathorn', 'Initials': 'S', 'LastName': 'Phutinart', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Bangkokthonburi University, Bangkok, Thailand.'}, {'ForeName': 'Suttichai', 'Initials': 'S', 'LastName': 'Krisanaprakornkit', 'Affiliation': 'Department of Oral Biology and Diagnostic Sciences, Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Anupong', 'Initials': 'A', 'LastName': 'Makeudom', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Boonsiva', 'Initials': 'B', 'LastName': 'Suzuki', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Bangkokthonburi University, Bangkok, Thailand.'}, {'ForeName': 'Eduardo Yugo', 'Initials': 'EY', 'LastName': 'Suzuki', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Bangkokthonburi University, Bangkok, Thailand.'}]",Korean journal of orthodontics,['10.4041/kjod.2020.50.3.188']
3135,32475902,"Efficacy and safety of miglitol- or repaglinide-based combination therapy with alogliptin in drug-naïve patients with type 2 diabetes: An open-label, single-center, parallel, randomized control pilot study.","BackgroundCombination therapy with an alpha-glucosidase inhibitor or glinide plus a dipeptidyl peptidase-4 inhibitor is thought to be effective for glycemic control because of its effects on postprandial hyperglycemia. However, no studies have directly compared the efficacy and safety of these two combination therapies.MethodsEighteen patients with type 2 diabetes were studied. All had diabetes not adequately controlled with diet and exercise therapy and an HbA1c level of ≥7.5%; none were receiving any medication for diabetes. The patients were randomized to either miglitol- or repaglinide-based combination therapy with alogliptin. Patients received miglitol or repaglinide monotherapy for 3 months (the miglitol and repaglinide groups, respectively), after which alogliptin was added to each group as combination therapy for 3 months. A meal tolerance test (MTT) was performed before the start of treatment and at the end of monotherapy and combination therapy.ResultsDuring the study period, decreases in HbA1c and glycated albumin were significantly greater in the repaglinide group than in the miglitol group; however, there was no significant difference between treatment groups at the end of the study. At the end of monotherapy, insulin secretion relative to glucose elevation (ISG 0-30 : area under the curve of insulin from 0 to 30 min during MTT [AUC 0-30 of IRI]/AUC 0-30 of plasma glucose) was significantly increased only in the repaglinide group; ISG 0-30 did not significantly increase in either group after the addition of alogliptin.ConclusionsThe addition of alogliptin to repaglinide monotherapy did not cause glucose-independent inappropriate insulin secretion and did not appear to increase the incidence of hypoglycemia.",2020,"ResultsDuring the study period, decreases in HbA1c and glycated albumin were significantly greater in the repaglinide group than in the miglitol group; however, there was no significant difference between treatment groups at the end of the study.","['MethodsEighteen patients with type 2 diabetes', 'drug-naïve patients with type 2 diabetes']","['repaglinide', 'miglitol- or repaglinide-based combination therapy with alogliptin', 'miglitol or repaglinide monotherapy', 'Combination therapy with an alpha-glucosidase inhibitor or glinide plus']","['incidence of hypoglycemia', 'insulin secretion relative to glucose elevation (ISG 0-30 : area under the curve of insulin', 'Efficacy and safety', 'efficacy and safety', 'HbA1c and glycated albumin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0066535', 'cui_str': 'miglitol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C1299007', 'cui_str': 'Alpha-glucosidase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]",,0.0245686,"ResultsDuring the study period, decreases in HbA1c and glycated albumin were significantly greater in the repaglinide group than in the miglitol group; however, there was no significant difference between treatment groups at the end of the study.","[{'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Okajima', 'Affiliation': 'Department of Endocrinology, Chiba-Hokusoh Hospital, Nippon Medical School.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Sugihara', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Graduate School of Medicine.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Emoto', 'Affiliation': 'Department of Endocrinology, Chiba-Hokusoh Hospital, Nippon Medical School.'}]",Journal of Nippon Medical School = Nippon Ika Daigaku zasshi,['10.1272/jnms.JNMS.2021_88-205']
3136,32475932,[Analysis of Basic Life Support Training Provided to Pharmacy Students Using Feedback Device].,"The quality of chest compression affects survival after sudden cardiac arrest, particularly when it occurs out of hospital. Pharmacy students should acquire basic life support skills as part of the model core curriculum of pharmacy education. Here, we trained first-year students at the Faculty of Pharmacy to deliver cardiopulmonary resuscitation and used a manikin with a real-time feedback device that quantified chest compression skills. Students were classified into shallow compressions (SC; <50 mm) and deep compressions (DC; ≥50 mm) groups based on the depth of chest compressions measured prior to training. After training, the mean compression depth (mm) was significantly shallower for the SC, than the DC group and many students in the SC group did not reach a depth of 50 mm. Similarly, students were classified into slow compression rate (SR; ≤120/min) and rapid compression rate (RR; >120/min) groups based on the results of training in the rate of chest compressions. Significant differences in mean compression rates were not found between the groups. However, correct compression rate (%), the percentage of maintaining 100-120 compression/min was significantly higher in the SR, than in the RR group. Chest compression rates correlated with compression depth, and chest compression tended to be too shallow in group that was too fast. The quality of chest compression might be improved by delivering chest compressions at a constant rate within the recommended range.",2020,"After training, the mean compression depth (mm) was significantly shallower for the SC, than the DC group and many students in the SC group did not reach a depth of 50 mm.",['Pharmacy Students'],['Pharmacy to deliver cardiopulmonary resuscitation and used a manikin with a real-time feedback device that quantified chest compression skills'],"['slow compression rate (SR; ≤120/min) and rapid compression rate', 'quality of chest compression', 'correct compression rate', 'mean compression rates', 'mean compression depth', 'Chest compression rates']","[{'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}]","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",,0.0192071,"After training, the mean compression depth (mm) was significantly shallower for the SC, than the DC group and many students in the SC group did not reach a depth of 50 mm.","[{'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Maruyama', 'Affiliation': 'Research Center for the Promotion of Pharmacy and Pharmaceutical Practice, School of Pharma-Sciences, Teikyo University.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'Teikyo Simulation Education Research Center, Teikyo University.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ohkura', 'Affiliation': 'Department of Medical and Pharmaceutical Sciences, School of Pharma-Sciences, Teikyo University.'}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Kihara-Negishi', 'Affiliation': 'Department of Life and Health Sciences, School of Pharma-Sciences, Teikyo University.'}, {'ForeName': 'Nobu', 'Initials': 'N', 'LastName': 'Akiyama', 'Affiliation': 'Teikyo Simulation Education Research Center, Teikyo University.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Kaneko', 'Affiliation': 'Teikyo Simulation Education Research Center, Teikyo University.'}]",Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan,['10.1248/yakushi.20-00005']
3137,32470421,"Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study.","BACKGROUND
Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
METHODS
This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
FINDINGS
Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3-4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
INTERPRETATION
This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.
FUNDING
Boston Scientific.",2020,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","['313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned', '23 implanting centres in the USA', ""patients with Parkinson's disease"", ""motor symptoms of Parkinson's disease"", '160 patients included in the interim analysis, 121 (76', 'Between May 17, 2013, and Nov 30, 2017', '313 patients were enrolled across 23 sites', ""Parkinson's disease (INTREPID"", ""Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent""]","['subthalamic nucleus DBS with a novel MICC device', 'Subthalamic nucleus deep brain stimulation', 'Deep brain stimulation (DBS', 'active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group', 'novel multiple independent contact current-controlled (MICC) device']","['ON time without troublesome dyskinesias', 'anti-parkinsonian medications', 'mean number of waking hours per day with good symptom control and no troublesome dyskinesias', '26 serious adverse events', 'mean change from baseline visit to 3 months post-randomisation']","[{'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",313.0,0.575314,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","[{'ForeName': 'Jerrold L', 'Initials': 'JL', 'LastName': 'Vitek', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA. Electronic address: vitek004@umn.edu.'}, {'ForeName': 'Roshini', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Alexander I', 'Initials': 'AI', 'LastName': 'Tröster', 'Affiliation': 'Department of Clinical Neuropsychology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Schrock', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'House', 'Affiliation': 'Neurosurgical Associates, Murray, UT, USA.'}, {'ForeName': 'Monique L', 'Initials': 'ML', 'LastName': 'Giroux', 'Affiliation': 'Movement and Neuroperformance Center of Colorado, Englewood, CO, USA; Clinical Research Neurology, Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Adam O', 'Initials': 'AO', 'LastName': 'Hebb', 'Affiliation': 'Department of Neurological Surgery, Kaiser Permanente, Denver, CO, USA.'}, {'ForeName': 'Sierra M', 'Initials': 'SM', 'LastName': 'Farris', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA; Movement and Neuroperformance Center of Colorado, Englewood, CO, USA.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Whiting', 'Affiliation': 'Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Leichliter', 'Affiliation': 'Department of Neurology, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Ostrem', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'San Luciano', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Verhagen Metman', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Sani', 'Affiliation': 'Department of Neurological Surgery, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Karl', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mustafa S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Tatter', 'Affiliation': 'Department of Neurosurgery, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Ihtsham', 'Initials': 'I', 'LastName': 'Ul Haq', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Andre G', 'Initials': 'AG', 'LastName': 'Machado', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Gostkowski', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tagliati', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Adam N', 'Initials': 'AN', 'LastName': 'Mamelak', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Okun', 'Affiliation': 'Department of Neurology, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Foote', 'Affiliation': 'Department of Neurosurgery, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Moguel-Cobos', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Ponce', 'Affiliation': 'Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jules M', 'Initials': 'JM', 'LastName': 'Nazzaro', 'Affiliation': 'Department of Neurosurgery, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Cathrin M', 'Initials': 'CM', 'LastName': 'Buetefisch', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Gross', 'Affiliation': 'Department of Neurosurgery, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Corneliu C', 'Initials': 'CC', 'LastName': 'Luca', 'Affiliation': 'Department of Neurology, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Jagid', 'Affiliation': 'Department of Neurosurgery, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Gonzalo J', 'Initials': 'GJ', 'LastName': 'Revuelta', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Takacs', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Pourfar', 'Affiliation': 'Department of Neurology, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Alon Y', 'Initials': 'AY', 'LastName': 'Mogilner', 'Affiliation': 'Department of Neurosurgery, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Duker', 'Affiliation': 'Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': 'Mandybur', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Rosenow', 'Affiliation': 'Department of Neurosurgery, Northwestern University School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Cooper', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Park', 'Affiliation': 'Department of Neurosurgery, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Suketu M', 'Initials': 'SM', 'LastName': 'Khandhar', 'Affiliation': 'Department of Neurology, Kaiser Permanente Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sedrak', 'Affiliation': 'Department of Neurosurgery, Kaiser Permanente Medical Center, Redwood City, CA, USA.'}, {'ForeName': 'Fenna T', 'Initials': 'FT', 'LastName': 'Phibbs', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Julie G', 'Initials': 'JG', 'LastName': 'Pilitsis', 'Affiliation': 'Department of Neurosurgery, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Uitti', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Starr', 'Affiliation': 'Department of Neurosurgery, University of California, San Francisco, San Francisco, CA, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30108-3']
3138,32470438,"Evaluation of the efficacy and safety of deferiprone compared with deferasirox in paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2): a multicentre, randomised, open-label, non-inferiority, phase 3 trial.","BACKGROUND
Transfusion-dependent haemoglobinopathies require lifelong iron chelation therapy with one of the three iron chelators (deferiprone, deferasirox, or deferoxamine). Deferasirox and deferiprone are the only two oral chelators used in adult patients with transfusion-dependent haemoglobinopathies. To our knowledge, there are no randomised clinical trials comparing deferiprone, a less expensive iron chelator, with deferasirox in paediatric patients. We aimed to show the non-inferiority of deferiprone versus deferasirox.
METHODS
DEEP-2 was a phase 3, multicentre, randomised trial in paediatric patients (aged 1 month to 18 years) with transfusion-dependent haemoglobinopathies. The study was done in 21 research hospitals and universities in Italy, Egypt, Greece, Albania, Cyprus, Tunisia, and the UK. Participants were receiving at least 150 mL/kg per year of red blood cells for the past 2 years at the time of enrolment, and were receiving deferoxamine (<100 mg/kg per day) or deferasirox (<40 mg/kg per day; deferasirox is not registered for use in children aged <2 years so only deferoxamine was being used in these patients). Any previous chelation treatment was permitted with a 7-day washout period. Patients were randomly assigned 1:1 to receive orally administered daily deferiprone (75-100 mg/kg per day) or daily deferasirox (20-40 mg/kg per day) administered as dispersible tablets, both with dose adjustment for 12 months, stratified by age (<10 years and ≥10 years) and balanced by country. The primary efficacy endpoint was based on predefined success criteria for changes in serum ferritin concentration (all patients) and cardiac MRI T2-star (T2*; patients aged >10 years) to show non-inferiority of deferiprone versus deferasirox in the per-protocol population, defined as all randomly assigned patients who received the study drugs and had available data for both variables at baseline and after 1 year of treatment, without major protocol violations. Non-inferiority was based on the two-sided 95% CI of the difference in the proportion of patients with treatment success between the two groups and was shown if the lower limit of the two-sided 95% CI was greater than -12·5%. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with EudraCT, 2012-000353-31, and ClinicalTrials.gov, NCT01825512.
FINDINGS
435 patients were enrolled between March 17, 2014, and June 16, 2016, 393 of whom were randomly assigned to a treatment group (194 to the deferiprone group; 199 to the deferasirox group). 352 (90%) of 390 patients had β-thalassaemia major, 27 (7%) had sickle cell disease, five (1%) had thalassodrepanocytosis, and six (2%) had other haemoglobinopathies. Median follow-up was 379 days (IQR 294-392) for deferiprone and 381 days (350-392) for deferasirox. Non-inferiority of deferiprone versus deferasirox was established (treatment success in 69 [55·2%] of 125 patients assigned deferiprone with primary composite efficacy endpoint data available at baseline and 1 year vs 80 [54·8%] of 146 assigned deferasirox, difference 0·4%; 95% CI -11·9 to 12·6). No significant difference between the groups was shown in the occurrence of serious and drug-related adverse events. Three (2%) cases of reversible agranulocytosis occurred in the 193 patients in the safety analysis in the deferiprone group and two (1%) cases of reversible renal and urinary disorders (one case of each) occurred in the 197 patients in the deferasirox group. Compliance was similar between treatment groups: 183 (95%) of 193 patients in the deferiprone group versus 192 (97%) of 197 patients in the deferisirox group.
INTERPRETATION
In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment. Considering the need for availability of more chelation treatments in paediatric populations, deferiprone offers a valuable treatment option for this age group.
FUNDING
EU Seventh Framework Programme.",2020,"In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment.","['paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2', 'paediatric patients with transfusion-dependent', '21 research hospitals and universities in Italy, Egypt, Greece, Albania, Cyprus, Tunisia, and the UK', 'paediatric patients (aged 1 month to 18 years) with transfusion-dependent haemoglobinopathies', 'group versus 192 (97%) of 197 patients in the deferisirox group', '435 patients were enrolled between March 17, 2014, and June 16, 2016, 393 of whom were randomly assigned to a treatment group (194 to the deferiprone group; 199 to the deferasirox group', 'adult patients with transfusion-dependent haemoglobinopathies', 'paediatric patients']","['daily deferasirox', 'daily deferiprone', 'deferoxamine', 'haemoglobinopathies, deferiprone', 'Deferasirox and deferiprone', 'deferiprone', 'deferasirox', 'deferiprone versus deferasirox']","['Safety', 'Compliance', 'serum ferritin concentration', 'efficacy and safety', 'occurrence of serious and drug-related adverse events', 'sickle cell disease', 'reversible agranulocytosis', 'reversible renal and urinary disorders']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathy'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0041388', 'cui_str': 'Tunisia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C0011145', 'cui_str': 'Deferoxamine'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0001824', 'cui_str': 'Agranulocytosis'}, {'cui': 'C0042075', 'cui_str': 'Disorder of urinary tract'}]",435.0,0.255378,"In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment.","[{'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Maggio', 'Affiliation': 'Department of Hematology and Rare Diseases, V Cervello, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy. Electronic address: aurelio.maggio@villasofia.it.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kattamis', 'Affiliation': 'First Department of Pediatrics, National and Kapodistriam University of Athens, Athens, Greece.'}, {'ForeName': 'Mariagrazia', 'Initials': 'M', 'LastName': 'Felisi', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Reggiardo', 'Affiliation': 'Biostatistics and Data Management Unit, Medi Service, Genoa, Italy.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'El-Beshlawy', 'Affiliation': 'Pediatric Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bejaoui', 'Affiliation': 'Pediatrics and Bone Marrow Transplantation Centre, Tunis, Tunisia.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Sherief', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Soteroula', 'Initials': 'S', 'LastName': 'Christou', 'Affiliation': 'Thalassaemia Center, Hospital Archbishop Makarios III, Nicosia, Cyprus.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cosmi', 'Affiliation': 'Clinica Pediatrica, Azienda Ospedaliero Universitaria (AOU) Sassari, Sassari, Italy.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Della Pasqua', 'Affiliation': 'Clinical Pharmacology and Therapeutics Group, University College London, London, UK.'}, {'ForeName': 'Giovanni Carlo', 'Initials': 'GC', 'LastName': 'Del Vecchio', 'Affiliation': 'UO Pediatrica B Trambusti, AOU Consorziale Policlinico-Giovanni XXIII, Bari, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Filosa', 'Affiliation': 'UOSD Malattie rare del globulo rosso, AORN A Cardarelli, Napoli, Italy.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Cuccia', 'Affiliation': 'UOC Ematologia con Talassemia, Dipartimento di Medicina, AO Civico Di Cristina-Benfratelli, Palermo, Italy.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Hassab', 'Affiliation': 'Department of Pediatrics and Clinical Research Center, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Manika', 'Initials': 'M', 'LastName': 'Kreka', 'Affiliation': 'Pediatrics Department, University Hospital Center Mother Teresa, Tirana, Albania.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Origa', 'Affiliation': 'DH Talassemia, Ospedale Pediatrico Microcitemico A CAO, AO G Brotzu, Cagliari, Italy.'}, {'ForeName': 'Maria Caterina', 'Initials': 'MC', 'LastName': 'Putti', 'Affiliation': ""Department of Women's and Child's Health (DSDB), University Hospital, Padova, Italy.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spino', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Telfer', 'Affiliation': 'Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Tempesta', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vitrano', 'Affiliation': 'Department of Hematology and Rare Diseases, V Cervello, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.'}, {'ForeName': 'Yu Chung', 'Initials': 'YC', 'LastName': 'Tsang', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Zaka', 'Affiliation': 'Center of Thalassemia, Hospital Ihsan Cabej, Lushnje, Albania.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Tricta', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Bonifazi', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Ceci', 'Affiliation': 'Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Valenzano, Italy.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30100-9']
3139,32471080,"Effectiveness of a Family Intervention to Increase Physical Activity in Disadvantaged Areas-A Healthy Generation, a Controlled Pilot Study.","There are large social inequalities in health. The purpose of this study was to evaluate the effects of a family intervention on physical activity (PA) and sedentary time (ST) in children and their parents. In this controlled pilot study, all 8-9-year-old children from four schools from a socioeconomically disadvantaged area in Sweden were invited and 67 children and 94 parents were included. The intervention was run by a foundation in co-operation with the municipality. The 9-month program included: (1) activity sessions, (2) healthy meals, (3) health information and (4) parental support groups. PA was primary outcome and ST was secondary outcome, measured by accelerometry. In total, 40 of the children (60%) and 45 of the adults (50%) had at least one day of valid accelerometer data at both baseline and follow-up. Significant intervention effects for the whole group were found in total PA ( p = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p = 0.02, MD 8 min/day) during the weekends. There were no differences between groups in the other PA variables or ST. This pilot study shows that it is possible to influence PA in families from a disadvantaged area through a family program.",2020,"Significant intervention effects for the whole group were found in total PA ( p = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p = 0.02, MD 8 min/day) during the weekends.","['all 8-9-year-old children from four schools from a socioeconomically disadvantaged area in Sweden were invited and 67 children and 94 parents were included', 'families from a disadvantaged area through a family program', 'Disadvantaged Areas', 'children and their parents']","['activity sessions, (2) healthy meals, (3) health information and (4) parental support groups', 'family intervention', 'Family Intervention']","['physical activity (PA) and sedentary time (ST', 'total PA']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0240404,"Significant intervention effects for the whole group were found in total PA ( p = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p = 0.02, MD 8 min/day) during the weekends.","[{'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Andermo', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Nordenfelt', 'Affiliation': 'The Foundation A Healthy Generation, 118 63 Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lidin', 'Affiliation': 'Department of Medicine, Karolinska Institutet, 171 76 Stockholm, Sweden.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska Institutet, 171 76 Stockholm, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph17113794']
3140,32471106,Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study.,"BACKGROUND
the aim of this study was to investigate the pharmacokinetic (PK) and safety profile of high-dose vitamin D supplementation, comparing different schedules (daily, weekly, or bi-weekly) in an otherwise healthy vitamin D-deficient population. Methods : single-center, open-label study on healthy subjects deficient in vitamin D (25 (OH)D < 20 ng/mL), randomized to receive cholecalciferol (DIBASE ® , Abiogen Pharma, Italy) using three different schedules: Group A: 10,000 IU/day for eight weeks followed by 1000 IU/day for four weeks; Group B: 50,000 IU/week for 12 weeks, Group C: 100,000 IU/every other week for 12 weeks. Total cumulative doses were: 588,000 IU, 600,000 IU, 600,000 IU. The treatment regimens corresponded to the highest doses allowed for cholecalciferol for the correction of vitamin D deficiency in adults in Italy.
RESULTS
mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C. On day 28, all subjects showed 25 (OH)D levels ≥ 20 ng/mL and 93.1% had 25 (OH)D levels ≥ 30 ng/mL. On day 56 and 84, all subjects had 25 (OH)D levels ≥ 30 ng/mL. No serious adverse events occurred during the study.
CONCLUSIONS
normalization of 25 (OH)D serum levels was quickly attained with all the studied regimens. A more refracted schedule provided a higher systemic 25 (OH)D exposure.",2020,"RESULTS
mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C.","['otherwise healthy vitamin D-deficient population', 'adults in Italy', 'healthy subjects deficient in vitamin D (25 (OH)D < 20 ng/mL', 'Healthy Subjects with Vitamin D Deficiency']","['high-dose vitamin D supplementation', 'Oral Cholecalciferol', 'cholecalciferol (DIBASE ®', 'cholecalciferol']","['OH)D levels ≥', '25 (OH)D levels ≥', 'serious adverse events', 'normalization of 25 (OH)D serum levels', 'pharmacokinetic (PK) and safety profile', 'mean 25 (OH)D plasma levels']","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.0510382,"RESULTS
mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C.","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Fassio', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Adami', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Rossini', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Giollo', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Caimmi', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bixio', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Ombretta', 'Initials': 'O', 'LastName': 'Viapiana', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Milleri', 'Affiliation': 'Centro Ricerche Cliniche di Verona SRL, 37131 Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Gatti', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Gatti', 'Affiliation': 'Rheumatology Unit, University of Verona, 37131 Verona, Italy.'}]",Nutrients,['10.3390/nu12061553']
3141,32471186,Vitamin E-Bonded Membranes Do Not Influence Markers of Oxidative Stress in Hemodialysis Patients with Homozygous Glutathione Transferase M1 Gene Deletion.,"BACKGROUND
Increased oxidative stress is a hallmark of end-stage renal disease. Hemodialysis (HD) patients lacking glutathione transferase M1 (GSTM1) enzyme activity exhibit enhanced oxidative DNA damage and higher mortality rate than those with active GSTM1 enzyme. To our knowledge, this is the first study to use the vitamin E-bonded membranes (VEM) in patients with homozygous GSTM1 gene deletion, and we aimed to determine the effect of VEM on oxidative and inflammatory status in HD patients with homozygous GSTM1 gene deletion.
METHODS
GSTM1 genotypes were determined by polymerase chain reaction (PCR) in 170 chronic HD patients. Those with GSTM1-null genotype were randomized and 80 were included in the study. Forty of them were dialyzed for three months with VEM, while the other forty were dialyzed with high-flux same-surface polysulfone dialyzers. Markers of protein and lipid oxidative damage and inflammation (thiol groups, malondialdehyde (MDA), Interleukin-6 (IL-6)), together with plasma antioxidant activity (glutathione peroxidase (GPX), superoxide dismutase (SOD)) were determined.
RESULTS
Seventy-five patients finished the study. There were no differences at baseline in markers of protein and lipid oxidative damage, inflammation and plasma antioxidant activity. After three months of therapy, GPX, MDA, and thiol groups increased significantly in both groups, but without statistical significance between groups. SOD and C reactive protein (CRP) did not change significantly during the three-month period. IL-6 increased in the control group, and at the same time, decreased in the VEM group, but without statistical significance. Hemoglobin (Hb) value, red blood cells, erythropoiesis resistance index (ERI), serum ferritin and iron did not change significantly within or between groups. Regarding other laboratory parameters, proteins, albumins, triglycerides, serum phosphorus, serum bicarbonate and Kt/V showed significant improvements within groups but with no significant difference between groups.
CONCLUSIONS
Our data shows that therapy with VEM over three months had no benefit over standard polysulfone membrane in decreasing by-products of oxidative stress and inflammation in dialysis patients lacking GSTM1 enzyme activity.",2020,"After three months of therapy, GPX, MDA, and thiol groups increased significantly in both groups, but without statistical significance between groups.","['Seventy-five patients finished the study', '170 chronic HD patients', 'Hemodialysis Patients with Homozygous Glutathione Transferase M1 Gene Deletion', 'patients with homozygous GSTM1 gene deletion', 'Those with GSTM1-null genotype were randomized and 80 were included in the study', 'HD patients with homozygous GSTM1 gene deletion']","['VEM', 'Vitamin E-Bonded Membranes', 'polymerase chain reaction (PCR', 'vitamin E-bonded membranes (VEM']","['Hemoglobin (Hb) value, red blood cells, erythropoiesis resistance index (ERI), serum ferritin and iron', 'Markers of protein and lipid oxidative damage and inflammation (thiol groups, malondialdehyde (MDA), Interleukin-6 (IL-6)), together with plasma antioxidant activity (glutathione peroxidase (GPX), superoxide dismutase (SOD', 'Oxidative Stress', 'SOD and C reactive protein (CRP', 'markers of protein and lipid oxidative damage, inflammation and plasma antioxidant activity', 'IL-6', 'triglycerides, serum phosphorus, serum bicarbonate and Kt/V']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0017837', 'cui_str': 'Glutathione transferase'}, {'cui': 'C0017260', 'cui_str': 'Gene deletion'}, {'cui': 'C1738886', 'cui_str': 'GSTM1 protein, human'}, {'cui': 'C0456148', 'cui_str': 'Null'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0429662', 'cui_str': 'kt/V'}]",170.0,0.0267835,"After three months of therapy, GPX, MDA, and thiol groups increased significantly in both groups, but without statistical significance between groups.","[{'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Djuric', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Suvakov', 'Affiliation': 'Institute of Medical and Clinical Biochemistry, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Simic', 'Affiliation': 'Institute of Medical and Clinical Biochemistry, 11000 Belgrade, Serbia.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Markovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Djurdja', 'Initials': 'D', 'LastName': 'Jerotic', 'Affiliation': 'Institute of Medical and Clinical Biochemistry, 11000 Belgrade, Serbia.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Jankovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bulatovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Tosic Dragovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Damjanovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Marinkovic', 'Affiliation': 'Institute of Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Radomir', 'Initials': 'R', 'LastName': 'Naumovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Dimkovic', 'Affiliation': 'Clinical Department for Renal Diseases, Zvezdara University Medical Center, 11000 Belgrade, Serbia.'}]",Toxins,['10.3390/toxins12060352']
3142,32471214,Total Hip Arthroplasty Using Imageless Computer-Assisted Navigation-2-Year Follow-Up of a Prospective Randomized Study.,"The purpose of this study is to compare computer-assisted to manual implantation-techniques in total hip arthroplasty (THA) and to find out if the computer-assisted surgery is able to improve the clinical and functional results and reduce the dislocation rate in short-terms after THA. We performed a concise minimum 2-year follow-up of the patient cohort of a prospective randomized study published in 2014 and evaluated if the higher implantation accuracy in the navigated group can be seen as an important determinant of success in total hip arthroplasty. Although a significant difference was found in mean postoperative acetabular component anteversion and in the outliers regarding inclination and anteversion (p < 0.05) between the computer-assisted and the manual-placed group, we could not find significant differences regarding clinical outcome or revision rates at 2-years follow-up. The implantation accuracy in the navigated group can be regarded as an important determinant of success in THA, although no significant differences in clinical outcome could be detected at short-term follow-up. Therefore, further long-term follow-up of our patient group is needed.",2020,"Although a significant difference was found in mean postoperative acetabular component anteversion and in the outliers regarding inclination and anteversion (p < 0.05) between the computer-assisted and the manual-placed group, we could not find significant differences regarding clinical outcome or revision rates at 2-years follow-up.","['total hip arthroplasty (THA', 'total hip arthroplasty']","['computer-assisted to manual implantation-techniques', 'computer-assisted surgery']","['dislocation rate', 'implantation accuracy', 'mean postoperative acetabular component anteversion', 'clinical outcome or revision rates', 'Total Hip Arthroplasty']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0949696', 'cui_str': 'Computer-Assisted Surgery'}]","[{'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]",,0.0177396,"Although a significant difference was found in mean postoperative acetabular component anteversion and in the outliers regarding inclination and anteversion (p < 0.05) between the computer-assisted and the manual-placed group, we could not find significant differences regarding clinical outcome or revision rates at 2-years follow-up.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lass', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Olischar', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Kubista', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Waldhoer', 'Affiliation': 'Department of Epidemiology, Center of Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090 Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Giurea', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Windhager', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9061620']
3143,32471226,Proximal Tibiofibular Dislocation in a Closing-Wedge High Tibial Osteotomy Causes Lateral Radiological Gapping of the Knee: A Prospective Randomized Study.,"BACKGROUND
To determine whether a proximal tibiofibular joint dislocation (TFJD) increases lateral compartment gapping more than a fibular head osteotomy (FHO) during a closing-wedge high tibial osteotomy (CWHTO). The second objective was to determine whether lateral compartment gapping affects clinical outcomes.
METHODS
A prospective randomized clinical study was carried out that included 18 patients in Group 1 (FHO) and 18 in Group 2 (TFJD). Varus-stress radiographs of all the patients with both knees at full extension and at 30 ° of flexion were studied pre-operatively and 12 months post-operatively. Lateral compartment gapping was measured in millimeters. The Knee Society Score (KSS) was used to assess clinical stability.
RESULTS
The difference between the pre- and post-operative measurements relative to gapping in the lateral knee compartment at 0 ° of knee flexion was 1.3 mm (SD 1.8) in Group 1 and 4.5 mm (SD 2.4) in Group 2 ( p = 0.006). At 30 ° of knee flexion, this difference was 1.9 mm (SD 1.2) in Group 1 and 5.2 mm (SD 3.1) in Group 2 ( p = 0.01). No differences were observed in the pre- and post-operative period relative to gapping in healthy knees. Pre-operatively, both groups presented similar KSS knee values: Group 1 with 54.7 (SD 11.7), Group 2 with 54.8 (SD 11.1) (n.s.). Post-operatively, these values were also similar: Group 1 with 93.2 (SD 7.4), Group 2 with 93.5 (SD 5.5) (n.s.).
CONCLUSIONS
In patients who have undergone a CWHTO, TFJ dislocation increases knee lateral compartment gapping when compared to an FHO at 0 ° and 30 ° of knee flexion. However, this fact seems to have no repercussion on the functional status of the knees as measured with the KSS at the one-year follow-up.",2020,"At 30 ° of knee flexion, this difference was 1.9 mm (SD 1.2) in Group 1 and 5.2 mm (SD 3.1) in Group 2 ( p = 0.01).","['Proximal Tibiofibular Dislocation in a Closing-Wedge High Tibial Osteotomy Causes Lateral Radiological Gapping of the Knee', 'included 18 patients in Group 1 (FHO) and 18 in Group 2 (TFJD']","['proximal tibiofibular joint dislocation (TFJD', 'TFJ dislocation']",['Knee Society Score (KSS'],"[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0223908', 'cui_str': 'Head of fibula structure'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0730180', 'cui_str': 'Tibiofibular joint structure'}]","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0730180', 'cui_str': 'Tibiofibular joint structure'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0935532,"At 30 ° of knee flexion, this difference was 1.9 mm (SD 1.2) in Group 1 and 5.2 mm (SD 3.1) in Group 2 ( p = 0.01).","[{'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Torres-Claramunt', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Sánchez-Soler', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Hinarejos', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Sala-Pujals', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Leal-Blanquet', 'Affiliation': ""Orthopaedic Department, Hospital de Igualada, Consorci Sanitari de l'Anoia, 08700 Barcelona, Spain.""}, {'ForeName': 'Joan Carles', 'Initials': 'JC', 'LastName': 'Monllau', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autònoma Barcelona, 08003 Barcelona, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9061622']
3144,32471369,Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial.,"BACKGROUND
Induction of labor (IoL) is an increasingly common obstetric procedure. Foley catheter IoL is recommended by WHO. It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods. Insertion is typically via speculum but digital insertion has been reported to be faster, better tolerated and with similar universal insertion success compared to speculum insertion in a mixed population of nulliparas and multiparas. Transcervical procedure is more challenging in nulliparas and when the cervix is unripe. We evaluated the ease and tolerability of digital compared to speculum insertion of Foley catheter for induction of labor in nulliparas with unripe cervixes.
METHODS
A randomized trial was performed in a university hospital in Malaysia. Participants were nulliparas at term with unripe cervixes (Bishop Score ≤ 5) admitted for IoL who were randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position. Primary outcomes were insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure. All primary outcomes were recorded after the first insertion.
RESULTS
Data from 86 participants were analysed. Insertion duration (with standard deviation) was 2.72 ± 1.85 vs. 2.25 ± 0.55 min p = 0.12, pain score (VNRS) median [interquartile range] 3.5 [2-5] vs. 3 [2-5] p = 0.72 and failure 2/42 (5%) vs. 0/44 (0%) p = 0.24 for digital vs speculum respectively. There was no significant difference found between the two groups for all three primary outcomes. Induction to delivery 30.7 ± 9.4 vs 29.6 ± 11.5 h p = 0.64, Cesarean section 25/60 (64%) vs 28/64 (60%) RR 0.9 95% CI p = 0.7 and maternal satisfaction VNRS score with the birth process 7 [IQR 6-8] vs 7 [7-8] p = 0.97 for digital vs. speculum arms respectively. Other labor, delivery and neonatal secondary outcomes were not significantly different.
CONCLUSION
Digital and speculum insertion in nulliparas with unripe cervixes had similar insertion performance. As digital insertion required less equipment and consumables, it could be the preferred insertion method for the equally adept and the insertion technique to train towards.
TRIAL REGISTRATION
This trial was registered with ISRCTN registration number 13804902 on 15 November 2017.",2020,It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods.,"['registration number 13804902 on 15 November 2017', 'nulliparas with unripe cervixes', '86 participants were analysed', 'university hospital in Malaysia', 'Participants were nulliparas at term with unripe cervixes (Bishop Score\u2009≤\u20095) admitted for IoL who were randomized to', 'Nulliparas with unripe cervix']","['speculum insertion of Foley catheter', 'Transcervical procedure', 'digital or speculum-aided transcervical Foley catheter insertion in lithotomy position', 'Speculum versus digital insertion of Foley catheter', 'Digital and speculum insertion']","['uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate', 'maternal satisfaction VNRS score', 'pain score', 'Insertion duration', 'insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0457226', 'cui_str': 'Uneffaced cervix'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]","[{'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0150665', 'cui_str': 'Lithotomy position'}]","[{'cui': 'C0269842', 'cui_str': 'Hypertonic uterine dysfunction'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",86.0,0.415544,It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods.,"[{'ForeName': 'Hang Min', 'Initials': 'HM', 'LastName': 'Chia', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peng Chiong', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia. pctan@um.edu.my.'}, {'ForeName': 'Sze Ping', 'Initials': 'SP', 'LastName': 'Tan', 'Affiliation': ""King's College London, The Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Mukhri', 'Initials': 'M', 'LastName': 'Hamdan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siti Zawiah', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03029-0']
3145,32471373,"Percutaneous mastoid electrical stimulator improves Poststroke depression and cognitive function in patients with Ischaemic stroke: a prospective, randomized, double-blind, and sham-controlled study.","BACKGROUND
Poststroke depression can lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of a percutaneous mastoid electrical stimulator (PMES) plus antidepressants on poststroke depression and cognitive function.
METHODS
This study was a prospective, randomized, double-blind, and sham-controlled study. A total of 258 clinically depressed ischaemic stroke patients within 14 days of index stroke were randomly assigned to the PMES plus antidepressant (PMES group, N = 125) and sham plus antidepressant (sham group, N = 133) groups. All patients underwent the Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months(M6) after ischaemic stroke. Primary outcomes were the percentage of patients showing a treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score ≤ 9) at 6 months. The secondary outcome was the percentage of patients with a MoCA score < 26.
RESULTS
The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively). The mean value of the HRSD score change [M (month)6-baseline] was significantly higher in the PMES group than in the sham group at 6 months (- 11.93 ± 5.32 vs - 10.48 ± 6.10, P = 0.036, respectively). The percentage of patients with MoCA scores < 26 was lower in the PEMS group than in the sham group (12.0% vs 24.06%, P = 0.012,respectively), and the mean value of the MoCA score change (M6-baseline) was higher in the PMES group than in the sham group (3.50 ± 2.55 vs 2.72 ± 2.52, P = 0.005, respectively).
CONCLUSION
These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition.
TRIAL REGISTRATION
This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018.",2020,"The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively).","['258 clinically depressed ischaemic stroke patients within 14\u2009days of index stroke', 'patients with Ischaemic stroke']","['PMES', 'PMES plus antidepressant (PMES group, N\u2009=\u2009125) and sham plus antidepressant', 'percutaneous mastoid electrical stimulator (PMES) plus antidepressants', 'Percutaneous mastoid electrical stimulator']","['mean value of the MoCA score change (M6-baseline', 'treatment response and depression remission', 'mean value of the HRSD score change [M (month)6-baseline', 'Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test', 'Poststroke depression and cognitive function', 'percentage of patients with a MoCA score\u2009<\u200926', 'poststroke depression and cognitive function', 'percentage of patients showing a treatment response', 'percentage of patients with MoCA scores', 'HRSD score) and depression remission (HRSD score']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0446908', 'cui_str': 'Mastoid structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",258.0,0.250207,"The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively).","[{'ForeName': 'Taoli', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Lanying', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China. 531324679@qq.com.""}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Wei Wei', 'Initials': 'WW', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, First Affiliated Hospital, Chongqing Medical University, Chongqing, 400030, PR China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'College of Electrical Engineering, Institute of Electrical Technology, Chongqing University, Chongqing, 400030, PR China.'}]",BMC neurology,['10.1186/s12883-020-01795-0']
3146,32471382,NORAD01-GRECCAR16 multicenter phase III non-inferiority randomized trial comparing preoperative modified FOLFIRINOX without irradiation to radiochemotherapy for resectable locally advanced rectal cancer (intergroup FRENCH-GRECCAR- PRODIGE trial).,"BACKGROUND
Preoperative radiochemotherapy (RCT) is recommended in France prior to total mesorectal excision in patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N+) because it has been shown to improve local control. Preoperative RCT has also disadvantages including the absence of proven impact on metastatic recurrence and the risk of late side effects on bowel and genitourinary function. In patients with primarily resectable LARC, preoperative systemic chemotherapy without pelvic irradiation could be used as an alternative to RCT.
METHODS
This study is a multicenter, open-label randomized, 2-arm phase III non-inferiority trial. Patients with mid or low resectable LARC (cT3N0 or cT1-T3N+ with circumferential resection margin [CRM] > 2 mm on pretreatment MRI) will be randomized to either modified FOLFIRINOX for 3 months or RCT (Cap50 intensified-modulated radiotherapy). All patients have restaging MRI after preoperative treatment. The primary endpoint is 3-year progression-free survival (PFS) from the time to randomization including progression during preoperative treatment. Secondary endpoints are treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response after preoperative treatment. The number of patients required is 574.
DISCUSSION
The choice of modified FOLFIRINOX for preoperative chemotherapy is supported by recent and consistent data on safety and efficacy of this regimen on rectal cancer. The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors. However and first of all, the non-inferiority of preoperative chemotherapy compared to RCT on oncologic outcome has to be validated. If this study demonstrates the non-inferiority of chemotherapy compared to RCT, this can lead to a crucial change in clinical practice in a large subset of rectal cancer patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03875781 (March 15, 2019). Version 1.1.",2020,The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors.,"['rectal cancer patients', 'Patients with mid or low resectable LARC', 'patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N']","['preoperative modified FOLFIRINOX without irradiation to radiochemotherapy', 'Preoperative radiochemotherapy (RCT', 'RCT', 'NORAD01-GRECCAR16', 'cT3N0 or cT1-T3N+ with circumferential resection margin [CRM]\u2009', 'Cap50 intensified-modulated radiotherapy', 'chemotherapy']","['3-year progression-free survival (PFS', 'treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4742253', 'cui_str': 'folfirinox'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}]",,0.14794,The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Brouquet', 'Affiliation': 'Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre, Groupe Hospitalier Universitaire Paris Sud, Assistance Publique, Hôpitaux de Paris, 63, rue Gabriel Péri, Le Kremlin Bicetre, 94275, France. antoine.brouquet@aphp.fr.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': ""Service d'Oncologie Digestive, Hôpital de la Pitié Salpétrière, Assistance Publique, Hôpitaux de Paris, Paris, 75013, France.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Huguet', 'Affiliation': 'Service de Radiothérapie, Hôpital Tenon, Assistance Publique, Hôpitaux de Paris, Paris, 75020, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Karoui', 'Affiliation': 'Service de Chirurgie Digestive, Hôpital Européen Georges Pompidou, Assistance Publique, Hôpitaux de Paris, Paris, 75015, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Artru', 'Affiliation': ""Centre d'oncologie Jean Mermoz, Lyon, France.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Sabbagh', 'Affiliation': 'Service de Chirurgie Digestive, CHU Amiens, Amiens, 60000, France.'}, {'ForeName': 'Jérémie H', 'Initials': 'JH', 'LastName': 'Lefèvre', 'Affiliation': 'Service de Chirurgie Générale et Digestive, Hôpital Saint Antoine, Assistance Publique, Hôpitaux de Paris, Paris, 75012, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Unité de recherche clinique CHU, Besançon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'Service de Chirurgie Digestive et Oncologique, CHU Lille, Lille, 59000, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique Paris VII, Assistance Publique, Hôpitaux de Paris, Paris, 75010, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Benoist', 'Affiliation': 'Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre, Groupe Hospitalier Universitaire Paris Sud, Assistance Publique, Hôpitaux de Paris, 63, rue Gabriel Péri, Le Kremlin Bicetre, 94275, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-06968-1']
3147,32471387,Developmental and sequenced one-to-one educational intervention (DS1-EI) for autism spectrum disorder and intellectual disability: a two-year interim report of a randomized single-blind multicenter controlled trial.,"BACKGROUND
Children with autism spectrum disorder (ASD) and moderate to severe intellectual disability (ID) face many challenges. There is little evidence-based research into educational settings for children with ID and ASD and in France. Little is known about how this unserved population could benefit from intervention and education. This study assessed the feasibility and efficacy of a new intervention model using an individualized educational approach.
METHODS
We conducted a randomized, single-blind controlled trial to assess a novel intervention: the ""Developmental and Sequenced One-to-One Intervention (DS1-EI)"". In DS1-EI, trained teachers worked one-to-one with each child in a small classroom setting, offering 10 h per week of the intervention. The focus was on encouraging spontaneous communication, promoting skills through play with peers, supporting positive interactions, and developmental and sequenced learning. We enrolled 5- to 9-year-old children with ASD and ID across 11 French child care institutions for children with co-occurring ASD and ID. Participants were matched in dyads by developmental quotient and randomized to the treatment-as-usual (TAU) group or the DS1-EI group. Independent raters blindly assessed the primary variables: The Childhood Autism Rating scale (CARS) and the Psychoeducational Profile, third edition (PEP-3). The secondary variables included the Vineland Adaptive Behavior Scale II (VABS-II) and the Clinical Global Assessment Scale (CGAS). Here we perform interim analyses at 24 months.
RESULTS
At baseline, 72 participants were randomized. Nine patients (5 in the DS1-EI group and 4 in the TAU group) dropped out of the study. Using linear mixed models, both intent-to-treat (ITT) and per-protocol (PP) analyses at the 12-, 18- and 24-month outcomes showed no significant group nor group-by-time interaction effects. However, we found significant improvements in most primary and secondary variables over time in both groups.
CONCLUSIONS
The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months. However, the low dropout rate shows that DS1-EI is feasible, and well accepted. As the study is still ongoing, we need to wait for data at 36 months to ensure whether DS1-EI could be recommended.
TRIAL REGISTRATION
ANSM130282B-31 (April 16, 2013) and ACTRN12616000592448. Registered 6 May 2016, retrospectively registered, http://www.anzctr.org.au/.",2020,The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months.,"['autism spectrum disorder and intellectual disability', 'Nine patients (5 in the DS1-EI group and 4 in the TAU group) dropped out of the study', 'children with ID and ASD and in France', '9-year-old children with ASD and ID across 11 French child care institutions for children with co-occurring ASD and ID', 'Children with autism spectrum disorder (ASD) and moderate to severe intellectual disability (ID', '72 participants were randomized']","['DS1-EI', 'http://www.anzctr.org.au', 'Developmental and sequenced one-to-one educational intervention (DS1-EI', 'Developmental and Sequenced One-to-One Intervention (DS1-EI', 'TAU']","['feasibility and efficacy', 'Vineland Adaptive Behavior Scale II (VABS-II) and the Clinical Global Assessment Scale (CGAS', 'Childhood Autism Rating scale (CARS) and the Psychoeducational Profile, third edition (PEP-3']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales'}, {'cui': 'C0077959', 'cui_str': 'VAB II protocol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0055633', 'cui_str': 'Chromogranin A'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}]",72.0,0.0655832,The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Tanet', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Hubert-Barthelemy', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 75013, Paris, France.""}, {'ForeName': 'Marie-Noëlle', 'Initials': 'MN', 'LastName': 'Clément', 'Affiliation': 'Hôpital de jour André Boulloche, association Cerep-Phymentin, 56 rue du Faubourg Poissonnière, 75010, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Soumille', 'Affiliation': ""Association Régionale pour l'Intégration, 26 rue Saint Sébastien, 13006, Marseille, France.""}, {'ForeName': 'Graciela C', 'Initials': 'GC', 'LastName': 'Crespin', 'Affiliation': ""Association Programme de Recherche et d'Etudes sur l'Autisme, 7, square Dunois, 75013, Paris, France.""}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Pellerin', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 75013, Paris, France.""}, {'ForeName': 'François-André', 'Initials': 'FA', 'LastName': 'Allaert', 'Affiliation': 'CEN Biotech, Parc Mazen-Sully, Zone des biotechnologies, Impasse Françoise Dolto, 21000, Dijon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France. david.cohen@aphp.fr.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Saint-Georges', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02156-z']
3148,32471390,Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial.,"BACKGROUND
It is well known that women suffer from negative consequences following breast cancer (BC) treatment and that their largely varying needs for rehabilitation are often unmet. Up to 43% of these women are at risk of developing chronic distress requiring complex interventions; however, how to early identify and meet these women's needs is unknown, leaving them with suboptimal chances of rehabilitation. The aim of the ReScreen study is to develop a model for and evaluate the effect of screening-based, individualized rehabilitation following primary BC treatment.
METHODS
The ReScreen study is designed as a complex intervention. Women with newly diagnosed BC are consecutively included in a three-armed randomized controlled trial. At inclusion, patients score their distress level on the Distress Thermometer (scale of 0-10) aiming to identify patients with extended rehabilitation needs. Patients scoring ≥5 are randomized to the intervention or control group while patients scoring ≤4 are followed longitudinally as an observational group. Patients in the intervention group, in conjunction with a dedicated research nurse, create an individualized rehabilitation plan based on an evidence-based decision support tool that was developed to create a solid base for the intervention. The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period. The intervention will be evaluated through self-reported data focusing on physical and psychological outcomes as well as evaluation of satisfaction with care at baseline, 2 weeks and 3, 6, 9 and 12 months. Evaluation will also include health economic aspects based on register data and patients' and relatives' experiences of the rehabilitation process. In addition, optimal cut-off levels for distress as an indicator for extended rehabilitation needs will be investigated.
DISCUSSION
This study will provide important knowledge related to effectiveness of screening-based identification of rehabilitation needs and standardized evidence-based, individualized rehabilitation after primary BC treatment. With a complex intervention design, this study has the potential to form a comprehensive knowledge base which includes tools and guidelines for implementation into clinical practice.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03434717. Registered February 15, 2018.",2020,The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period.,"['Women with newly diagnosed BC', 'women suffer from negative consequences following breast cancer (BC', 'primary breast cancer treatment']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],[],,0.127976,The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period.,"[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Olsson Möller', 'Affiliation': 'Department of Nursing and Integrated Health Sciences, Faculty of Health Sciences, Kristianstad University, Kristianstad, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Clinical Sciences Lund, Surgery, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malmström', 'Affiliation': 'Department of Health Sciences, Lund University, Box 157, 221 00, Lund, Sweden. marlene.malmstrom@med.lu.se.'}]",BMC cancer,['10.1186/s12885-020-06815-3']
3149,32471400,"Effectiveness of a family intervention on health-related quality of life-a healthy generation, a controlled pilot trial.","BACKGROUND
Physical activity is associated with better health, but knowledge about health promoting interventions, including physical activity for families in disadvantaged areas and the impact on health-related quality of life (HRQOL) is sparse. The aim of this study was to assess HRQOL in children and their parents after participation in the programme ""A Healthy Generation"".
METHODS
The programme is delivered in socioeconomically disadvantaged areas in Sweden and offers physical activity and a healthy meal or fruit twice a week from August to May to families with children in grade 2. Children (n = 67), aged 8-9 years, and their parents (n = 90) participated in this controlled study conducted in four schools, two control and two intervention schools. HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively. Analyses of covariance (ANCOVAs), linear regression and Pearson's correlation were conducted.
RESULTS
There were no significant differences between intervention and control in HRQOL among children or adults after the intervention. However, in a subgroup of children (n = 20) and adults (n = 29) with initial low HRQOL scores at baseline, there was a significant difference between the intervention group and control group after the intervention (children (total score): p = 0.02; adults (social domain) p = 0.04). Furthermore, within the intervention group, there was a significant relationship between level of participation in ""A Healthy Generation"" and the physical domain of HRQOL among girls (r = 0.44, p = 0.01), but not boys (r = - 0.07, p = 0.58).
CONCLUSION
Participation in the programme ""A Healthy Generation"" did not show a significant intervention effect on HRQOL in general. However, the findings suggest that HRQOL may be increased for children and adults with low HRQOL in disadvantaged areas. This knowledge can contribute to the development of health promoting interventions in such areas, and to more equitable health.
TRIAL REGISTRATION
ISRCTN ISRCTN11660938. Retrospectively registered 23 September 2019.",2020,"HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively.","['children and their parents after participation in the programme ""A Healthy Generation', 'children and adults with low HRQOL in disadvantaged areas', 'Children (n\u2009=\u200967), aged 8-9\u2009years, and their parents (n\u2009=\u200990) participated in this controlled study conducted in four schools, two control and two intervention schools']",['family intervention'],"['HRQOL', 'Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale', 'level of participation in ""A Healthy Generation"" and the physical domain of HRQOL', 'health-related quality of life-a healthy generation', 'initial low HRQOL scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0628145,"HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Andermo', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. Susanne.andermo@ki.se.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lidin', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Hedby', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Nordenfelt', 'Affiliation': 'The Foundation A Healthy Generation, Stockholm, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",BMC public health,['10.1186/s12889-020-08895-z']
3150,32476455,A multicomponent intervention to decrease sedentary time during hospitalization: a quasi-experimental pilot study.,"OBJECTIVE
The aim of this study was to evaluate the feasibility and preliminary effects of a multicomponent intervention to decrease sedentary time during and shortly after hospitalization.
DESIGN
This is a quasi-experimental pilot study comparing outcomes in patients admitted before and after the implementation of the intervention.
SETTING
The study was conducted in a university hospital.
SUBJECTS
Participants were adult patients undergoing elective organ transplantation or vascular surgery.
INTERVENTIONS
In the control phase, patients received usual care, whereas in the intervention phase, patients also received a multicomponent intervention to decrease sedentary time. The intervention comprised eight elements: paper and digital information, an exercise movie, an activity planner, a pedometer and Fitbit Flex™, a personal activity coach and an individualized digital training program.
MEASURES
Measures of feasiblity were the self-reported use of the intervention components (yes/no) and satisfaction (low-high = 0-10). Main outcome measure was the median % of sedentary time measured by an accelerometer worn during hospitalization and 7-14 days thereafter.
RESULTS
A total of 42 controls (mean age = 59 years, 62% male) and 52 intervention patients (58 years, 52%) were included. The exercise movie, paper information and Fitbit Flex were the three most frequently used components, with highest satisfaction scores for the fitbit, paper information, exercise movie and digital training. Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively. The difference at Day 6 reached statistical significance (difference = 41 min/day, P = 0.01). No differences were seen after discharge.
CONCLUSION
Implementing a multicomponent intervention to reduce sedentary time appeared feasible and may be effective during but not directly after hospitalization.",2020,"Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively.","['The study was conducted in a university hospital', 'patients admitted before and after the implementation of the intervention', 'A total of 42 controls (mean age = 59\u2009years, 62% male) and 52 intervention patients (58\u2009years, 52%) were included', 'Participants were adult patients undergoing elective organ transplantation or vascular surgery']","['digital information, an exercise movie, an activity planner, a pedometer and Fitbit Flex™, a personal activity coach and an individualized digital training program', 'multicomponent intervention']","['Median sedentary time', 'sedentary time', 'median % of sedentary time measured by an accelerometer worn during hospitalization']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0189748,"Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Conijn', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'van Bodegom-Vos', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Volker', 'Affiliation': 'Department for Innovation, Quality + Research, Basalt Rehabilitation Center, The Hague/Leiden, The Netherlands.'}, {'ForeName': 'Bja', 'Initials': 'B', 'LastName': 'Mertens', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Huurman', 'Affiliation': 'Department of Transplantation Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Schaik', 'Affiliation': 'Department of Vascular Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Tpm', 'Initials': 'T', 'LastName': 'Vliet Vlieland', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jjl', 'Initials': 'J', 'LastName': 'Meesters', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}]",Clinical rehabilitation,['10.1177/0269215520920662']
3151,32476465,Comparison of Anticoagulants for Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Pilot Study.,"BACKGROUND
Direct-acting oral anticoagulants are indicated for the treatment of nonvalvular atrial fibrillation, but their use in patients after undergoing cardiac surgery is poorly defined despite a high prevalence of postoperative atrial fibrillation in this population.
METHODS
Patients diagnosed with postoperative atrial fibrillation were prospectively randomized to warfarin or apixaban. Safety, efficacy, and economic outcomes were evaluated until their 4- to 6-week postoperative appointment.
RESULTS
While this pilot study was not powered to determine a difference in safety or efficacy, adverse event rates were similar to the published literature. It was noted that a patient's course of therapy when utilizing apixaban was significantly less costly than warfarin when including medication, bridging, and laboratory expenses.
CONCLUSION
Apixaban and warfarin both appeared to be safe and effective for anticoagulation throughout the duration of this pilot study in treating postoperative atrial fibrillation after coronary artery bypass grafting. Apixaban was associated with significantly less expense when bridging and monitoring costs were included in addition to medication expense.",2020,"RESULTS
While this pilot study was not powered to determine a difference in safety or efficacy","['Patients diagnosed with postoperative atrial fibrillation', 'patients after undergoing cardiac surgery']","['warfarin or apixaban', 'Coronary Artery Bypass Grafting', 'Anticoagulants', 'warfarin', 'Apixaban and warfarin', 'Apixaban']","['adverse event rates', 'safety or efficacy', 'Safety, efficacy, and economic outcomes', 'Postoperative Atrial Fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.119252,"RESULTS
While this pilot study was not powered to determine a difference in safety or efficacy","[{'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Chapin', 'Affiliation': 'Pharmacy Services, Sanford Health, Fargo, ND, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Leedahl', 'Affiliation': 'Pharmacy Services, Sanford Health, Fargo, ND, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Brown', 'Affiliation': 'University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Pasek', 'Affiliation': 'University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}, {'ForeName': 'Mitchell G', 'Initials': 'MG', 'LastName': 'Sand', 'Affiliation': 'University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}, {'ForeName': 'Maari L', 'Initials': 'ML', 'LastName': 'Loy', 'Affiliation': 'Pharmacy Services, Essentia Health, Fargo, ND, USA.'}, {'ForeName': 'Cornelius M', 'Initials': 'CM', 'LastName': 'Dyke', 'Affiliation': 'University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420929483']
3152,32476469,The effect of the visual exercise environment on the response to psychological stress: a pilot study.,"Background: Performing physical activity whilst exposed to nature can improve health. However, there is little evidence of its impact on stress outcomes. The aim of this study was to examine the influence of the visual exercise environment on the response to a psychosocial stressor. Methods: Eighteen participants were randomized to one of three conditions: i. nature; ii. built or; iii. control condition. Participants exercised for 30 min on a treadmill at 50% of their VO 2 max whilst viewing a video of either a natural or built environment or a blank screen. Following the exercise, participants completed the Trier Social Stress Test (TSST), a standardized laboratory stressor. Salivary samples were collected before, during and after the TSST to calculate cortisol reactivity and recovery. Results: One-way ANOVA revealed a significant effect of viewing condition on cortisol reactivity [ F (2, 11) = 4.686, p = .034; n 2 p = .460]; with significantly lower reactivity in the built compared to the nature condition ( p = .027, d = 1.73). There was no effect of condition on cortisol recovery ( p = .137; n 2 p = .257). Conclusions: In the context of the adverse health impact of lower (i.e., blunted) cortisol responding, these findings could indicate a negative impact of the built environment on stress responses.",2020,There was no effect of condition on cortisol recovery ( p = .137; n 2 p = .257).,['Eighteen participants'],"['VO 2 max whilst viewing a video of either a natural or built environment or a blank screen', 'Trier Social Stress Test (TSST', 'visual exercise environment']","['cortisol reactivity', 'cortisol recovery']","[{'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C4505382', 'cui_str': 'Built Environment'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",18.0,0.037352,There was no effect of condition on cortisol recovery ( p = .137; n 2 p = .257).,"[{'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Sciences, University of Essex, Colchester, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'School of Social Sciences, University of Westminster, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Law', 'Affiliation': 'School of Social Sciences, University of Westminster, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Naufahu', 'Affiliation': 'School of Life Sciences, University of Westminster, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Smyth', 'Affiliation': 'School of Social Sciences, University of Westminster, London, UK.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1770231']
3153,32476482,Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial.,"OBJECTIVE
To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons.
DESIGN
Randomized controlled trial.
SETTING
State welfare organization in Kamyaran, Kurdistan, Iran.
PARTICIPANTS
Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups.
INTERVENTIONS
Participants in the ACT group ( n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n = 29) received psychoeducation regarding depression.
MAIN MEASURES
Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively.
RESULTS
After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT -10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control -0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control -1.90 ± 1.04, P < 0.001).
CONCLUSION
Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.",2020,"Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.","['Participants in the ACT group ( n \u2009=\u200923', 'physically disabled persons', 'State welfare organization in Kamyaran, Kurdistan, Iran', 'Fifty-two physically disabled participants with a primary diagnosis of depression', 'persons with physical disability']","['acceptance and commitment therapy (ACT', 'ACT or control groups', 'psychoeducation regarding depression', 'standard ACT protocol']","[""participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability"", 'depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively', 'psychological flexibility', 'adaptive emotion regulation strategies', 'depressive symptoms']","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0086807', 'cui_str': 'Physically Disabled'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",52.0,0.106167,"Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Zemestani', 'Affiliation': 'Department of Clinical Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Sharmin', 'Initials': 'S', 'LastName': 'Mozaffari', 'Affiliation': 'Department of Clinical Psychology, University of Kurdistan, Sanandaj, Iran.'}]",Clinical rehabilitation,['10.1177/0269215520923135']
3154,32476800,Multi-modal radiomics model to predict treatment response to neoadjuvant chemotherapy for locally advanced rectal cancer.,"BACKGROUND
Neoadjuvant chemotherapy is currently recommended as preoperative treatment for locally advanced rectal cancer (LARC); however, evaluation of treatment response to neoadjuvant chemotherapy is still challenging.
AIM
To create a multi-modal radiomics model to assess therapeutic response after neoadjuvant chemotherapy for LARC.
METHODS
This retrospective study consecutively included 118 patients with LARC who underwent both computed tomography (CT) and magnetic resonance imaging (MRI) before neoadjuvant chemotherapy between October 2016 and June 2019. Histopathological findings were used as the reference standard for pathological response. Patients were randomly divided into a training set ( n = 70) and a validation set ( n = 48). The performance of different models based on CT and MRI, including apparent diffusion coefficient (ADC), dynamic contrast enhanced T1 images (DCE-T1), high resolution T2-weighted imaging (HR-T2WI), and imaging features, was assessed by using the receiver operating characteristic curve analysis. This was demonstrated as area under the curve (AUC) and accuracy (ACC). Calibration plots with Hosmer-Lemeshow tests were used to investigate the agreement and performance characteristics of the nomogram.
RESULTS
Eighty out of 118 patients (68%) achieved a pathological response. For an individual radiomics model, HR-T2WI performed better (AUC = 0.859, ACC = 0.896) than CT (AUC = 0.766, ACC = 0.792), DCE-T1 (AUC = 0.812, ACC = 0.854), and ADC (AUC = 0.828, ACC = 0.833) in the validation set. The imaging performance for extramural venous invasion detection was relatively low in both the training (AUC = 0.73, ACC = 0.714) and validation (AUC = 0.578, ACC = 0.583) sets. The multi-modal radiomics model reached an AUC of 0.925 and ACC of 0.886 in the training set, and an AUC of 0.93 and ACC of 0.875 in the validation set. For the clinical radiomics nomogram, good agreement was found between the nomogram prediction and actual observation.
CONCLUSION
A multi-modal nomogram using traditional imaging features and radiomics of preoperative CT and MRI adds accuracy to the prediction of treatment outcome, and thus contributes to the personalized selection of neoadjuvant chemotherapy for LARC.",2020,"The imaging performance for extramural venous invasion detection was relatively low in both the training (AUC = 0.73, ACC = 0.714) and validation (AUC = 0.578, ACC = 0.583) sets.","['118 patients with LARC who underwent both', 'locally advanced rectal cancer (LARC', 'locally advanced rectal cancer', 'between October 2016 and June 2019']","['computed tomography (CT) and magnetic resonance imaging (MRI) before neoadjuvant chemotherapy', 'neoadjuvant chemotherapy', 'LARC']","['imaging performance for extramural venous invasion detection', 'pathological response', 'area under the curve (AUC) and accuracy (ACC', 'apparent diffusion coefficient (ADC), dynamic contrast enhanced T1 images (DCE-T1), high resolution T2-weighted imaging (HR-T2WI), and imaging features']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",118.0,0.024511,"The imaging performance for extramural venous invasion detection was relatively low in both the training (AUC = 0.73, ACC = 0.714) and validation (AUC = 0.578, ACC = 0.583) sets.","[{'ForeName': 'Zheng-Yan', 'Initials': 'ZY', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Mou', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Xi-Jiao', 'Initials': 'XJ', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Radiology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China. songlab_radiology@163.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Radiology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Radiology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Chun-Chao', 'Initials': 'CC', 'LastName': 'Xia', 'Affiliation': 'Department of Radiology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Life Science, PDx, IPM team, GE Healthcare, Shanghai 210000, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.'}]",World journal of gastroenterology,['10.3748/wjg.v26.i19.2388']
3155,32476816,The correlation of cytokines and sensory hypersensitivity in mild dry eye patients characterized by symptoms outweighing signs.,"Purpose
To explore the correlation of tear and conjunctival cytokines and sensory hypersensitivity in mild dry eye (MDE) patients characterized by symptoms outweighing signs (DESOS).
Methods
The subjects comprised 39 patients with MDE characterized by DESOS, 18 patients with common MDE (CMDE), and 15 healthy controls. The patients with DESOS were randomly subdivided into two groups; the C-DESOS group received artificial tears only, and the G-DESOS group received artificial tears and 0.1% fluorometholone eye drops three times a day. Symptoms were assessed using the Ocular Surface Disease Index (OSDI) and the Neuropathic Pain Symptoms Inventory modified for Eye (NPSI-E) questionnaire. Ocular examinations and in vivo confocal microscopy (IVCM) were also employed. Tear and conjunctival cytokines were measured using Multiplex or RT-PCR on Days 0, 7, and 30. The correlation between the expression of cytokines and hypersensitivity status was analyzed.
Results
Compared with the CMDE and control groups, the DESOS groups showed a significant increase in symptom scores and in the ratio of symptoms versus signs. IL-1 β, IL-2, IL-6, and TNF-α in tears and conjunctiva increased in the DESOS groups compared to the CMDE and control groups, indicating a high correlation with hypersensitivity status in the DESOS groups. Glucocorticoid treatment significantly decreased the level of cytokines in tears and conjunctiva in the G-DESOS group and subsequently ameliorated the symptoms.
Conclusions
Tear and conjunctival cytokines, including IL-1 β, IL-2, IL-6, and TNF-α, were correlated with sensory hypersensitivity status in the DESOS groups, suggesting they play an important role in the discordance of symptoms outweighing signs.",2020,"IL-1 β, IL-2, IL-6, and TNF-α in tears and conjunctiva increased in the DESOS groups compared to the CMDE and control groups, indicating a high correlation with hypersensitivity status in the DESOS groups.","['39 patients with MDE characterized by DESOS, 18 patients with common MDE (CMDE), and 15 healthy controls', 'patients with DESOS', 'mild dry eye (MDE) patients characterized by symptoms outweighing signs (DESOS', 'mild dry eye patients characterized by symptoms outweighing signs']","['CMDE', 'Glucocorticoid', 'vivo confocal microscopy (IVCM', 'C-DESOS group received artificial tears only, and the G-DESOS group received artificial tears and 0.1% fluorometholone eye drops three times a day']","['Conclusions\n\n\nTear and conjunctival cytokines, including IL-1 β, IL-2, IL-6, and TNF-α', 'IL-1 β, IL-2, IL-6, and TNF-α in tears and conjunctiva', 'Ocular Surface Disease Index (OSDI) and the Neuropathic Pain Symptoms Inventory modified for Eye (NPSI-E) questionnaire', 'expression of cytokines and hypersensitivity status', 'level of cytokines in tears and conjunctiva', 'Tear and conjunctival cytokines', 'cytokines and sensory hypersensitivity', 'symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0016351', 'cui_str': 'Fluorometholone'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0009758', 'cui_str': 'Conjunctival structure'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",18.0,0.0262237,"IL-1 β, IL-2, IL-6, and TNF-α in tears and conjunctiva increased in the DESOS groups compared to the CMDE and control groups, indicating a high correlation with hypersensitivity status in the DESOS groups.","[{'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': '.The Third Affiliated Hospital, Guangzhou Medical University, 63 Duobao Road, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': '.The Third Affiliated Hospital, Guangzhou Medical University, 63 Duobao Road, Guangzhou, China.'}, {'ForeName': 'Shuangyong', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': '.The Third Affiliated Hospital, Guangzhou Medical University, 63 Duobao Road, Guangzhou, China.'}]",Molecular vision,[]
3156,32476881,Measuring activity in patients with sarcoidosis - a pilot trial of two wrist-worn accelerometer devices.,"Introduction: Increasing physical activity is associated with health benefits. Reduced physical activity has been noted in sarcoidosis, particularly where fatigue co-exists. Monitoring physical activity is possible with wrist-worn devices. This study compared two available devices to determine patient preference and compare wear-time, with a secondary outcome of comparing device outputs with fatigue scores. Methods: Patients with sarcoidosis wore two wrist-worn activity monitors (GENEActiv actiwatch and Actigraph GT3X-bt) separately for seven days each. Participants were randomly allocated to receive either device first. Participants completed the Fatigue Assessment Scale (FAS) questionnaire immediately before wearing the first device. All participants completed a questionnaire of their perception regarding each device after the wear period. Data from the devices was analysed for total wear time, time spent in moderate or vigorous activity (MVPA) and for time spent in sedentary behaviours. Results: Twelve patients with sarcoidosis were included. The GENEActiv device was preferred by ten (83.3%) participants. Wear time was greater with the GENEActiv device (1354 minutes/day vs 1079 minutes/day). Time spent in MVPA was slightly higher when recorded by the GENEActiv compared with the Actigraph. Moderately strong correlation was seen between FAS scores and sedentary time (r=-0.554), light activity (r=-0.585) and moderate activity (r=0.506). Discussion: A clear preference was demonstrated for the GENEActiv. This was reflected in higher wear time and suggests the device can be comfortably worn 24 hours per day. Data from this small cohort also suggests there is correlation between fatigue and activity scores in patients with sarcoidosis. (Sarcoidosis Vasc Diffuse Lung Dis 2018; 35: 62-68) .",2018,Wear time was greater with the GENEActiv device (1354 minutes/day vs 1079 minutes/day).,"['Twelve patients with sarcoidosis were included', 'patients with sarcoidosis - a pilot trial of two wrist-worn accelerometer devices', 'Patients with sarcoidosis', 'patients with sarcoidosis']",[],"['total wear time, time spent in moderate or vigorous activity (MVPA) and for time spent in sedentary behaviours', 'Time spent in MVPA', 'Wear time', 'physical activity', 'fatigue and activity scores', 'Fatigue Assessment Scale (FAS) questionnaire', 'FAS scores and sedentary time (r=-0.554), light activity (r=-0.585) and moderate activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036202', 'cui_str': 'Sarcoidosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4517464', 'cui_str': '0.585'}]",12.0,0.0600001,Wear time was greater with the GENEActiv device (1354 minutes/day vs 1079 minutes/day).,"[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Atkins', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK, NR4 7TJ.'}, {'ForeName': 'Andy P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK, NR4 7TJ.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Wilson', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK, NR4 7TJ.'}]","Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG",['10.36141/svdld.v35i1.5848']
3157,32476971,"Corrigendum to The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.",[This corrects the article DOI: 10.1177/1179573519899471.].,2020,[This corrects the article DOI: 10.1177/1179573519899471.].,['Patients With Ischemic Stroke in the Early Subacute Recovery Phase'],['Rehabilitation-oriented Virtual Reality Device'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",[],,0.125302,[This corrects the article DOI: 10.1177/1179573519899471.].,[],Journal of central nervous system disease,['10.1177/1179573520923280']
3158,32477199,Mindfulness-Based Student Training Leads to a Reduction in Physiological Evaluated Stress.,"Background and Objective
In today's fast-paced modern lifestyle, chronic stress has become a serious issue with potential consequences for our physical and mental health. The concept of mindfulness and its derived Mindfulness-Based Stress Reduction (MBSR) program is considered to be an effective stress management technique for patients as well as for healthy persons. The effects of MBSR interventions on their participants have been subject of previous research, especially with regard to psychological or social science approaches using self-reports and questionnaires. In contrast, medical investigations in this field have been less frequent and often somehow limited, for example, addressing only absolute (discrete) mean values for heart rate or blood pressure.
Methods
In this study, we have evaluated a Mindfulness Based Student Training program (MBST) by applying methods of biosignal analysis to examine its impact on the training participants' autonomic regulation. This intervention program included classical MBSR elements but was adapted to suit the normal daily needs of university students. We obtained the electrocardiogram, finger-pulse plethysmography, and respiration activity from students participating in either the intervention group (IGR, 38 subjects) or a passive control group (CON, 35 subjects) prior to and after 8 weeks of MBST intervention.
Results
When comparing various indices from heart rate variability, pulse wave variability, and respiration in linear and nonlinear domains, significant changes in the autonomic regulation were observed for the IGR group after 8 weeks of MBST.
Conclusion
The results indicate a reduced stress level exclusively for the intervention participants, and therefore, we assume a health benefit from the MBST program.",2020,"When comparing various indices from heart rate variability, pulse wave variability, and respiration in linear and nonlinear domains, significant changes in the autonomic regulation were observed for the IGR group after 8 weeks of MBST.
","['students participating in either the intervention group (IGR, 38 subjects) or a', 'healthy persons']","['Mindfulness-Based Stress Reduction (MBSR) program', 'Mindfulness Based Student Training program (MBST', 'Mindfulness-Based Student Training', 'passive control group (CON, 35 subjects) prior to and after 8 weeks of MBST intervention', 'MBSR interventions']","['autonomic regulation', 'heart rate variability, pulse wave variability, and respiration in linear and nonlinear domains', 'classical MBSR elements']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}]",38.0,0.0105734,"When comparing various indices from heart rate variability, pulse wave variability, and respiration in linear and nonlinear domains, significant changes in the autonomic regulation were observed for the IGR group after 8 weeks of MBST.
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Voss', 'Affiliation': 'Institute of Innovative Health Technologies (IGHT), Ernst-Abbe-Hochschule Jena, Jena, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bogdanski', 'Affiliation': 'Institute of Innovative Health Technologies (IGHT), Ernst-Abbe-Hochschule Jena, Jena, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Langohr', 'Affiliation': 'Jena Achtsamkeit, Jena, Germany.'}, {'ForeName': 'Reyk', 'Initials': 'R', 'LastName': 'Albrecht', 'Affiliation': 'Faculty of Social and Behavioral Sciences, Friedrich-Schiller-University Jena, Jena, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Sandbothe', 'Affiliation': 'Institute of Innovative Health Technologies (IGHT), Ernst-Abbe-Hochschule Jena, Jena, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00645']
3159,32477208,Training Positive Rumination in Expressive Writing to Enhance Psychological Adjustment and Working Memory Updating for Maladaptive Ruminators.,"Rumination is associated with psychological adjustment and working memory (WM) capacity. Studies have shown that psychological interventions can reduce negative rumination and improve psychological adjustment and WM capacity. The present study investigated the effect of positive rumination training in expressive writing on psychological adjustment and WM updating capacity. Within an experimental design, positive rumination was manipulated for 10 participants who were maladaptive ruminators in an experiment using a 5-week training compared to the control group with nine participants. Results revealed significant enhancement of psychological adjustment and the response time (RT) of WM updating in the experimental group but not in the control group. The two groups did not show significant difference of all the variables in pretest. However, the experimental group showed significantly better outcomes than the control group in posttest. The results suggest that positive rumination training in expressive writing is effective and rumination has a causal influence on WM updating capacity.",2020,Results revealed significant enhancement of psychological adjustment and the response time (RT) of WM updating in the experimental group but not in the control group.,['10 participants who were maladaptive ruminators in an experiment using a 5-week training compared to the control group with nine participants'],['positive rumination training'],"['psychological adjustment and working memory (WM) capacity', 'psychological adjustment and the response time (RT) of WM updating', 'negative rumination and improve psychological adjustment and WM capacity']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0557904', 'cui_str': 'Emotional adjustment'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",10.0,0.0192719,Results revealed significant enhancement of psychological adjustment and the response time (RT) of WM updating in the experimental group but not in the control group.,"[{'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Huizhong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00789']
3160,32477223,Meditative Movement Affects Working Memory Related to Neural Activity in Adolescents: A Randomized Controlled Trial.,"Numerous studies have revealed that meditative movement changes brain activity and improves the cognitive function of adults. However, there is still insufficient data on whether meditative movement contributes to the cognitive function of adolescents whose brain is still under development. Therefore, this study aimed to uncover the effects of meditative movement on the cognitive performance and its relation with brain activity in adolescents. Forty healthy adolescent participants (mean age of 17∼18) were randomly allocated into two groups: meditative movement and control group. The meditative movement group was instructed to perform the meditative movement, twice a day for 9 min each, for a duration of 3 weeks. During the same time of the day, the control group was instructed to rest under the same condition. To measure changes in cognitive abilities, a dual n-back task was performed before and after the intervention and analyzed by repeated two-way analysis of variance (ANOVA). During the task, electroencephalogram signals were collected to find the relation of brain activity with working memory performance and was analyzed by regression analysis. A repeated two-way ANOVA with Bonferroni correction showed that working memory performance was significantly increased by meditative movement compared with the retest effect. Based on regression analysis, the amplitude of high-beta rhythm in the F3 channel showed a significant correlation with dual n-back score in the experimental group after the intervention, while there was no correlation in the control group. Our results suggest that meditative movement improves the performance of working memory, which is related to brain activity in adolescents. Clinical Trial Registration: cris.nih.go.kr/cris, identifier KCT0004706.",2020,A repeated two-way ANOVA with Bonferroni correction showed that working memory performance was significantly increased by meditative movement compared with the retest effect.,"['Forty healthy adolescent participants (mean age of 17∼18', 'Adolescents', 'adolescents']",['meditative movement and control group'],"['cognitive abilities, a dual n-back task', 'performance of working memory', 'dual n-back score', 'working memory performance']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0259225,A repeated two-way ANOVA with Bonferroni correction showed that working memory performance was significantly increased by meditative movement compared with the retest effect.,"[{'ForeName': 'Hojung', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Korea Institute of Brain Science, Seoul, South Korea.'}, {'ForeName': 'Seung Chan', 'Initials': 'SC', 'LastName': 'An', 'Affiliation': 'Korea Institute of Brain Science, Seoul, South Korea.'}, {'ForeName': 'Nah Ok', 'Initials': 'NO', 'LastName': 'Kim', 'Affiliation': 'Korea Institute of Brain Science, Seoul, South Korea.'}, {'ForeName': 'Minkyu', 'Initials': 'M', 'LastName': 'Sung', 'Affiliation': 'Korea Institute of Brain Science, Seoul, South Korea.'}, {'ForeName': 'Yunjung', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Korea Institute of Brain Science, Seoul, South Korea.'}, {'ForeName': 'Ul Soon', 'Initials': 'US', 'LastName': 'Lee', 'Affiliation': 'Department of Brain Education, Global Cyber University, Cheonan-si, South Korea.'}, {'ForeName': 'Hyun-Jeong', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Korea Institute of Brain Science, Seoul, South Korea.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00931']
3161,32477416,"Correction to: Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy.",[This corrects the article DOI: 10.1186/s13223-020-00419-z.].,2020,[This corrects the article DOI: 10.1186/s13223-020-00419-z.].,[],['omalizumab'],[],[],"[{'cui': 'C0966225', 'cui_str': 'omalizumab'}]",[],,0.546869,[This corrects the article DOI: 10.1186/s13223-020-00419-z.].,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlois', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Lavergne', 'Affiliation': 'Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Leroux', 'Affiliation': 'Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Killer', 'Affiliation': 'Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Azzano', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Paradis', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Samaan', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lacombe-Barrios', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eiwegger', 'Affiliation': '4Division of Immunology and Allergy, Department of Paediatrics, The Hospital for Sick Children, The University of Toronto, Toronto, ON Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Upton', 'Affiliation': '4Division of Immunology and Allergy, Department of Paediatrics, The Hospital for Sick Children, The University of Toronto, Toronto, ON Canada.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Gordon Sussman Clinical Research, Toronto, ON Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Poder', 'Affiliation': '6Department of Management, Evaluation and Health Policy, School of Public Health, Université de Montréal, Montreal, QC Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Mâsse', 'Affiliation': 'Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Anne Des', 'Initials': 'AD', 'LastName': 'Roches', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bégin', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}]","Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology",['10.1186/s13223-020-00435-z']
3162,32477421,Gratitude Conversations: An Experimental Trial of an Online Parenting Tool.,"Gratitude is associated with a host of positive outcomes; yet, little is understood about the ways in which parents may foster gratitude in their children. The current study allows for the examination of one possible mechanism, namely parent-child conversations, that may be used to encourage gratitude in children. Using a rigorous experimental design, we tested whether an online program that was designed to enrich parents' skills in having conversations about gratitude with their children was effective in changing parents' socialization behaviors and children's gratitude. Results demonstrated that parents can successfully utilize an online program to enhance their gratitude-related communication. This training permeates other aspects of how parents socialize gratitude in children and positively impacts children's gratitude moments. Implications for program development and understanding the role of parents in the development of children's gratitude are discussed.",2020,"Using a rigorous experimental design, we tested whether an online program that was designed to enrich parents' skills in having conversations about gratitude with their children was effective in changing parents' socialization behaviors and children's gratitude.",['Gratitude Conversations'],[],[],[],[],[],,0.0193394,"Using a rigorous experimental design, we tested whether an online program that was designed to enrich parents' skills in having conversations about gratitude with their children was effective in changing parents' socialization behaviors and children's gratitude.","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Hussong', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Coffman', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Taylor E', 'Initials': 'TE', 'LastName': 'Thomas', 'Affiliation': 'University of North Carolina at Chapel Hill.'}]",The journal of positive psychology,['10.1080/17439760.2019.1610484']
3163,32477434,The impact of a self-management educational program coordinated through WhatsApp on diabetes control.,"Background
Social media can effectively mediate digital health interventions and thus, overcome barriers associated with face-to-face interaction.
Objective
To assess the impact of patient-centered diabetes education program administered through WhatsApp on glycosylated hemoglobin (HbA1c) values, assess the correlation, if any, between health literacy and numeracy on intervention outcomes.
Methods
During an 'intervention phase' spread over six months, target diabetic patients (N=109) received structured education through WhatsApp as per the American Association of Diabetes Educators Self-Care Behaviors recommendations. The control group with an equal number of participants received 'usual care' provided by health professionals void of the social media intervention. Changes in HbA1c levels were recorded thrice (at baseline, 3 and 6 months) for the test group and twice (baseline and 6 months) for the control group. Change in HbA1c values were compared and statistical significance was defined at p<0.05. Baseline health literacy and diabetes numeracy were assessed for both groups (N=218) using the Literacy Assessment for Diabetes (LAD), and the Diabetes Numeracy Test (DNT), respectively, and values were correlated with HbA1c change p<0.05. Participants' satisfaction with the intervention was also assessed.
Results
The average age of respondents was 41.98 (SD 15.05) years, with a diabetes history of 10.2 (SD 8.5) years. At baseline, the average HbA1c in the control and test groups were 8.4 (SD 1.06) and 8.5 (SD 1.29), respectively. After six months, a significant drop in HbA1c value was noticed in intervention group (7.7; SD 1.35; p= 0.001); with no significance in the control group (8.4; SD 1.32; p=0.032, paired t-test). Moreover, the reduction in HbA1c was more in the test group (0.7%) than the control group (0.1%) with a difference of 0.6% which is considered clinically significant. There was no significant correlation between LAD score and HbA1c at baseline (r=-0.203, p=0.064), 3 months (r=-0.123, p=0.266) and 6 months (r=-0.106, p= 0.337) Pearson correlation. A similar result was observed with DNT, where DNT score and HbA1c at baseline, 3 months and 6 months showed no correlation (r=0.112, 0.959 and 0.886; respectively) with HbA1c levels. Eighty percent of the respondents found the social media intervention 'beneficial' and suggested it be used long term.
Conclusions
Diabetes education via WhatsApp showed promising outcomes regardless of the level of patients' health literacy or numeracy.",2020,The control group with an equal number of participants received 'usual care' provided by health professionals void of the social media intervention.,"['The average age of respondents was 41.98 (SD 15.05) years, with a diabetes history of 10.2 (SD 8.5) years', 'diabetic patients (N=109) received']","[""usual care' provided by health professionals void of the social media intervention"", 'structured education through WhatsApp']","['Literacy Assessment for Diabetes (LAD), and the Diabetes Numeracy Test (DNT', 'Changes in HbA1c levels', 'LAD score and HbA1c', 'Baseline health literacy and diabetes numeracy', 'glycosylated hemoglobin (HbA1c) values', 'DNT score and HbA1c', 'average HbA1c', 'reduction in HbA1c', 'diabetes control', 'Change in HbA1c values', 'HbA1c value']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0437577,The control group with an equal number of participants received 'usual care' provided by health professionals void of the social media intervention.,"[{'ForeName': 'Muaed Al', 'Initials': 'MA', 'LastName': 'Omar', 'Affiliation': 'PhD. Associate Professor. Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University. Ajman (United Arab Emirates). m.alomar@ajman.ac.ae.'}, {'ForeName': 'Sanah', 'Initials': 'S', 'LastName': 'Hasan', 'Affiliation': 'PhD. Associate Professor. Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University. Ajman (United Arab Emirates). s.hasan@ajman.ac.ae.'}, {'ForeName': 'Subish', 'Initials': 'S', 'LastName': 'Palaian', 'Affiliation': 'PhD. Associate Professor. Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University. Ajman (United Arab Emirates). s.palaian@ajman.ac.ae.'}, {'ForeName': 'Shrouq', 'Initials': 'S', 'LastName': 'Mahameed', 'Affiliation': 'MSc. Research Assistant. Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University. Ajman (United Arab Emirates). s.mahameed@ajman.ac.ae.'}]",Pharmacy practice,['10.18549/PharmPract.2020.2.1841']
3164,32477475,Comparing the Effectiveness of Neurofeedback and Transcranial Direct Current Stimulation on Sleep Quality of Patients With Migraine.,"Introduction
Migraine is considered one of the most common primary headache disorders. Migraine attacks may occur due to a lack of sleep. Furthermore, sleep is regarded as one of the smoothing factors of migraine pain. Patients with sleep disorders often suffer from headaches when they wake up compared with healthy individuals.
Methods
This research was a quasi-experimental study with a pre-test-post-test design and a 2-month follow-up. The samples included 20 migraine patients within the age range of 15 to 55 years who were selected as volunteers for treatment by the neurologists and psychiatrists during 2017. The initial evaluation was then conducted based on the inclusion and exclusion criteria and using the Ahvaz migraine questionnaire, and Pittsburgh sleep quality index. The patients were randomly assigned to two neurofeedback (n=10) and transcranial Direct Current Stimulation (tDCS) (n=10) groups and evaluated three times. The obtained data were analyzed by the repeated measures ANCOVA and Chi-square test in SPSS.
Results
Based on the scores of both groups, no significant difference was observed between neurofeedback and tDCS groups. However, based on the results, neurofeedback decreased sleep latency, whereas tDCS increased sleep efficiency. Overall, these two treatments were effective in improving subjective sleep quality and sleep quality.
Conclusion
Both neurofeedback and tDCS treatments could significantly enhance sleep quality of the patients in the post-test and 2-month follow-up. Given the effectiveness of both treatments, neurofeedback and tDCS are recommended to be used for improving the sleep status of patients with migraine.",2019,Both neurofeedback and tDCS treatments could significantly enhance sleep quality of the patients in the post-test and 2-month follow-up.,"['20 migraine patients within the age range of 15 to 55 years who were selected as volunteers for treatment by the neurologists and psychiatrists during 2017', 'Patients with sleep disorders', 'Patients With Migraine', 'patients with migraine']","['transcranial Direct Current Stimulation (tDCS', 'Neurofeedback and Transcranial Direct Current Stimulation']","['Ahvaz migraine questionnaire, and Pittsburgh sleep quality index', 'Sleep Quality', 'sleep latency', 'subjective sleep quality and sleep quality', 'sleep quality', 'sleep efficiency']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",20.0,0.0126399,Both neurofeedback and tDCS treatments could significantly enhance sleep quality of the patients in the post-test and 2-month follow-up.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kosari', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Dadashi', 'Affiliation': 'Department of Clinical Psychology, Social Determinants of Health Research Center, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Maghbouli', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Vali Asr Hospital, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Hossin', 'Initials': 'H', 'LastName': 'Mostafavi', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Basic and clinical neuroscience,['10.32598/BCN.10.6.651.3']
3165,32477481,"Comparing the Efficacy of Anodal, Cathodal, and Sham Transcranial Direct Current Stimulation on Brain-Derived Neurotrophic Factor and Psychological Symptoms in Opioid-Addicted Patients.","Introduction
Today, addiction to opioids is a serious problem all over the world. Unfortunately, the consumption of these drugs and the number of addicted people have drastically increased. This research aimed at comparing the efficacy of anodal, cathodal, and sham transcranial Direct Current Stimulation (tDCS) on the Brain-Derived Neurotrophic Factor (BDNF) and psychological symptoms in opioid-addicted patients.
Methods
Thirty opioid-addicted patients were selected based on the Diagnostic and Statistical Manual of Mental Disorders, the Fifth Edition, through the convenience sampling method. They were then randomly assigned to 3 groups (10 in each group). The subjects were evaluated before and after tDCS by their serum level of BDNF, desires for drug questionnaire, and depression anxiety stress scale. The data were analyzed by the Kolmogorov-Smirnov test, one-way analysis of variance, as well as the Bonferroni test.
Results
Stimulating the Dorsolateral Prefrontal Cortex (DLPFC) led to a significant change in increasing the level of BDNF (P=0.031) and reducing the degree of depression (P=0.018), anxiety (P=0.001), stress (P=0.012), and decreased the level of craving (P=0.001) in opioid-addicted patients. There was no significant difference between active stimulation groups (anodal left/cathodal right and anodal right/cathodal left). The stimulation of the right DLPFC (group B) significantly increased BDNF in comparison with the sham group (sham tDCS) and decreased anxiety and craving. Nonetheless, no change was observed in depression and stress. The stimulation of the left DLPFC (group A) significantly reduced depression, anxiety, stress, and craving compared with the sham group, while there was no change in BDNF.
Conclusion
In addition to the conventional treatments of opioid-addicted patients, tDCS is an effective complementary treatment.",2019,There was no significant difference between active stimulation groups (anodal left/cathodal right and anodal right/cathodal left).,"['opioid-addicted patients', 'Opioid-Addicted Patients', 'Methods\n\n\nThirty opioid-addicted patients']","['anodal, cathodal, and sham transcranial Direct Current Stimulation (tDCS', 'tDCS', 'Anodal, Cathodal, and Sham Transcranial Direct Current Stimulation']","['level of craving', 'BDNF', 'anxiety', 'serum level of BDNF, desires for drug questionnaire, and depression anxiety stress scale', 'Brain-Derived Neurotrophic Factor and Psychological Symptoms', 'anxiety and craving', 'degree of depression', 'depression and stress', 'depression, anxiety, stress, and craving', 'level of BDNF']","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",30.0,0.0238118,There was no significant difference between active stimulation groups (anodal left/cathodal right and anodal right/cathodal left).,"[{'ForeName': 'Zakaria', 'Initials': 'Z', 'LastName': 'Eskandari', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Dadashi', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Hossin', 'Initials': 'H', 'LastName': 'Mostafavi', 'Affiliation': 'Department of Clinical Psychology, Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Armani Kia', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Pirzeh', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Basic and clinical neuroscience,['10.32598/BCN.10.6.1710.1']
3166,32477509,Comparing open conventional carpal tunnel release with mini-incision technique in the treatment of carpal tunnel syndrome: A non-randomized clinical trial.,"Background
Carpal tunnel syndrome (CTS) is the most common nerve entrapment neuropathy which is the result of the compression of the median nerve in the wrist. Currently, there is no consensus about the best treatment option. The purpose of this clinical trial was to compare the clinical outcomes of patients undergoing open CT release with mini-incision CT release.
Patients and methods
This clinical trial included 75 patients with CTS who were divided into two groups of 45 and 30 patients to undergo open-CT release or mini incision CT release respectively. Patients were evaluated pre-operatively, days after the surgery and then five months after the operation to record outcomes. At follow-up, the visual analogue scale (VAS) scores for pain, patients' satisfaction, return to work, length of scar, paresthesia, grip and opposition strength were measured.
Results
A total of 75 patients (mean age: 52.13 years, 73.3% female) underwent CTS surgery. Forty-five patients (60%) had open-CT release and 30 patients (40%) had mini-incision CT release. Postoperative pain and scar length were significantly lower in the mini incision group compared to open group (p < 0.001). The mini-incision CT group returned to work earlier than open group with higher satisfaction (p < 0.001). No significant differences were observed between two groups in respect to the improvement of the opposition, grip and paresthesia (p > 0.05).
Conclusion
Our study demonstrated that mini-incision CT release improves pain more effectively and has better quality of life because of smaller length of scar, immediate return to work and higher overall satisfaction. Neurosensory and motor improvements were also seen in both techniques with the same clinical impact.",2020,"No significant differences were observed between two groups in respect to the improvement of the opposition, grip and paresthesia (p > 0.05).
","['patients undergoing open CT release with mini-incision CT release', '75 patients (mean age: 52.13 years, 73.3% female) underwent', 'carpal tunnel syndrome', '75 patients with CTS who were divided into two groups of 45 and 30 patients to', '\n\n\nCarpal tunnel syndrome (CTS']","['conventional carpal tunnel release with mini-incision technique', 'mini-incision CT', 'CTS surgery', 'undergo open-CT release or mini incision CT']","['open-CT release', 'mini-incision CT release', 'Postoperative pain and scar length', ""visual analogue scale (VAS) scores for pain, patients' satisfaction, return to work, length of scar, paresthesia, grip and opposition strength"", 'opposition, grip and paresthesia', 'Neurosensory and motor improvements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0231519', 'cui_str': 'Diffuse rigidity'}]",75.0,0.0243699,"No significant differences were observed between two groups in respect to the improvement of the opposition, grip and paresthesia (p > 0.05).
","[{'ForeName': 'Jalaluddin', 'Initials': 'J', 'LastName': 'Khoshnevis', 'Affiliation': 'Division of Vascular & Endovascular Surgery, Department of Surgery, Shohada-Tajrish Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hojjat', 'Initials': 'H', 'LastName': 'Layegh', 'Affiliation': 'Division of Vascular & Endovascular Surgery, Department of Surgery, Shohada-Tajrish Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Yavari', 'Affiliation': 'Research Department, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Eslami', 'Affiliation': 'Department of Microbiology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Afsharfard', 'Affiliation': 'Division of Vascular & Endovascular Surgery, Department of Surgery, Shohada-Tajrish Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Reza Kalantar-Motamedi', 'Affiliation': 'Division of Vascular & Endovascular Surgery, Department of Surgery, Shohada-Tajrish Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Zarrintan', 'Affiliation': 'Division of Vascular & Endovascular Surgery, Department of Surgery, Shohada-Tajrish Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Annals of medicine and surgery (2012),['10.1016/j.amsu.2020.05.001']
3167,32477627,Physician Usage and Acceptance of a Machine Learning Recommender System for Simulated Clinical Order Entry.,"Clinical decision support tools that automatically disseminate patterns of clinical orders have the potential to improve patient care by reducing errors of omission and streamlining physician workflows. However, it is unknown if physicians will accept such tools or how their behavior will be affected. In this randomized controlled study, we exposed 34 licensed physicians to a clinical order entry interface and five simulated emergency cases, with randomized availability of a previously developed clinical order recommender system. With the recommender available, physicians spent similar time per case (6.7 minutes), but placed more total orders (17.1 vs. 15.8). The recommender demonstrated superior recall (59% vs 41%) and precision (25% vs 17%) compared to manual search results, and was positively received by physicians recognizing workflow benefits. Further studies must assess the potential clinical impact towards a future where electronic health records automatically anticipate clinical needs.",2020,"The recommender demonstrated superior recall (59% vs 41%) and precision (25% vs 17%) compared to manual search results, and was positively received by physicians recognizing workflow benefits.",['34 licensed physicians to a clinical order entry interface and five simulated emergency cases'],[],"['precision', 'superior recall']","[{'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",[],"[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",,0.0332352,"The recommender demonstrated superior recall (59% vs 41%) and precision (25% vs 17%) compared to manual search results, and was positively received by physicians recognizing workflow benefits.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Chiang', 'Affiliation': 'Center for Biomedical Informatics Research, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morales', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, CA.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Saini', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, CA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hom', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shieh', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Musen', 'Affiliation': 'Center for Biomedical Informatics Research, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Goldstein', 'Affiliation': 'Geriatrics Research Education and Clinical Center, Veteran Affairs Palo Alto Health Care System, Palo Alto, CA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': 'Center for Biomedical Informatics Research, Department of Medicine, Stanford University, Stanford, CA.'}]",AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science,[]
3168,32482534,"""Decision for adjuvant treatment in stage II colon cancer based on circulating tumor DNA:The CIRCULATE-PRODIGE 70 trial"".","BACKGROUND
Adjuvant treatment for stage II colon cancer remains debated. Finding a tool to select patients at risk for disease recurrence may help the clinical decision. Circulating tumor DNA (ctDNA) has been reported recently as a potential predictive marker for disease recurrence. We thus aim to test its ability to better select stage II colon cancer patients for adjuvant therapy.
METHODS
This national, phase III trial (NCT00002019-000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients. Patients aged 18 to 75 years with ECOG performance status ≤1 with R0 surgical resection of a pT3-T4aN0 colon or high rectum adenocarcinoma will be randomized within 63 days after curative-intent surgery, to adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-FU bolus 400 mg/m2 then 5FU Continuous infusion 2.4 g/m²) every two weeks for 12 cycles or observation. Patients will be followed for maximum 7 years. A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test]; 1-β, 80%). Secondary endpoints include 2-yr DFS, overall survival, and toxicity. Recruitement began End of January 2020.",2020,"A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test];","['Patients aged 18 to 75 years with ECOG performance status ≤1 with R0 surgical resection of a pT3-T4aN0 colon or high rectum adenocarcinoma', '000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients', 'stage II colon cancer', 'stage II colon cancer patients for adjuvant therapy', 'stage II colon cancer based on circulating tumor DNA']","['curative-intent surgery, to adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-FU bolus 400 mg/m2 then 5FU Continuous infusion 2.4 g/m²']","['survival (DFS', '2-yr DFS, overall survival, and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332393', 'cui_str': 'pT3 category'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.265571,"A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test];","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taïeb', 'Affiliation': 'Department of gastroenterology and GI Oncology, Georges-Pompidou European Hospital, AP-HP; Sorbonne Paris cité, Université de Paris, Paris, France. Electronic address: jtaieb75@gmail.com.'}, {'ForeName': 'Léonor', 'Initials': 'L', 'LastName': 'Benhaim', 'Affiliation': 'Département de chirurgie viscérale oncologique, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent Puig', 'Affiliation': 'Pole biologie, Hospital European George Pompidou, Paris, Île-de-France, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Emile', 'Affiliation': 'EA4340, Ambroise Pare Hospital, Beuvry, Hauts-de-France, France.'}, {'ForeName': 'Flore', 'Initials': 'F', 'LastName': 'Geillon', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Gastroenterology Department and Medical Oncology Department, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Manfredi', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Chauvenet', 'Affiliation': 'Department of Gastroenterology, Groupement hospitalier Sud, Hospices civils de Lyon, Pierre Bénite, France.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Taly', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive; EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Department of digestive oncology University hospital Dijon; University of Burgundy and Franche Comté, Dijon, France; Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Sorbonne Université and Hôpital Saint Antoine, Paris, France.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.04.010']
3169,32482541,"Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR.","BACKGROUND
In the phase III CASTOR study in relapsed or refractory multiple myeloma, daratumumab, bortezomib, and dexamethasone (D-Vd) demonstrated significant clinical benefit versus Vd alone. Outcomes after 40.0 months of median follow-up are discussed.
PATIENTS AND METHODS
Eligible patients had received ≥ 1 line of treatment and were administered bortezomib (1.3 mg/m 2 ) and dexamethasone (20 mg) for 8 cycles with or without daratumumab (16 mg/kg) until disease progression.
RESULTS
Of 498 patients in the intent-to-treat (ITT) population (D-Vd, n = 251; Vd, n = 247), 47% had 1 prior line of treatment (1PL; D-Vd, n = 122; Vd, n = 113). Median progression-free survival (PFS) was significantly prolonged with D-Vd versus Vd in the ITT population (16.7 vs. 7.1 months; hazard ratio [HR], 0.31; 95% confidence interval [CI], 0.25-0.40; P < .0001) and the 1PL subgroup (27.0 vs. 7.9 months; HR, 0.22; 95% CI, 0.15-0.32; P < .0001). In lenalidomide-refractory patients, the median PFS was 7.8 versus 4.9 months (HR, 0.44; 95% CI, 0.28-0.68; P = .0002) for D-Vd (n = 60) versus Vd (n = 81). Minimal residual disease (MRD)-negativity rates (10 -5 ) were greater with D-Vd versus Vd (ITT: 14% vs. 2%; 1PL: 20% vs. 3%; both P < .0001). PFS2 was significantly prolonged with D-Vd versus Vd (ITT: HR, 0.48; 95% CI, 0.38-0.61; 1PL: HR, 0.35; 95% CI, 0.24-0.51; P < .0001). No new safety concerns were observed.
CONCLUSION
After 3 years, D-Vd maintained significant benefits in patients with relapsed or refractory multiple myeloma with a consistent safety profile. D-Vd provided the greatest benefit at first relapse and increased MRD-negativity rates.",2019,"PFS2 was significantly prolonged with D-Vd versus Vd (ITT: HR, 0.48; 95% CI, 0.38-0.61; 1PL: HR, 0.35; 95% CI, 0.24-0.51; P < .0001).","['Patients With Previously Treated Multiple Myeloma', 'patients with relapsed or refractory multiple myeloma', '498 patients in the intent-to-treat (ITT) population (D-Vd, n\xa0= 251; Vd, n\xa0= 247', 'Eligible patients had received\xa0≥ 1 line of treatment and were\xa0administered']","['Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone', 'bortezomib', 'dexamethasone']","['MRD-negativity rates', 'PFS2', 'Median progression-free survival (PFS', 'Minimal residual disease (MRD)-negativity rates', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",-5.0,0.0659076,"PFS2 was significantly prolonged with D-Vd versus Vd (ITT: HR, 0.48; 95% CI, 0.38-0.61; 1PL: HR, 0.35; 95% CI, 0.24-0.51; P < .0001).","[{'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Department of Hematology, University Hospital of Salamanca/IBSAL, Salamanca, Spain.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Irmandade Da Santa Casa De Misericordia De São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Haematology Department, Concord Cancer Centre, Concord Hospital, University of Sydney, Concord NSW, Australia.'}, {'ForeName': 'Wolney', 'Initials': 'W', 'LastName': 'Barreto', 'Affiliation': 'Hospital Santa Marcelina, São Paulo, Brazil.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Fondazione IRCCS Instituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Seoul St. Mary's Hospital, Seoul, The Republic of Korea.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Medvedova', 'Affiliation': 'Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center of Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Schecter', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Amin', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia. Electronic address: aspencer@netspace.net.au.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2019.09.623']
3170,32482565,A Plea for Optimizing Selection in Current Adjuvant Immunotherapy Trials for High-risk Nonmetastatic Renal Cell Carcinoma According to Expected Cancer-specific Mortality.,"BACKGROUND
Tyrosine kinase inhibitor-based adjuvant therapy showed no survival benefits for patients with high-risk nonmetastatic renal cell carcinoma (nmRCC). Five randomized immune-oncology checkpoint inhibitor trials are ongoing. We assessed the effect of stage, grade, and histologic type on cancer-specific mortality (CSM) in candidates for 1 of the 4 North American ongoing immune-oncology checkpoint inhibitor trials of high-risk nmRCC.
PATIENTS AND METHODS
From the Surveillance, Epidemiology, and End Results database (2001-2015), we identified patients who had undergone surgery for nmRCC and had met the inclusion criteria for the PROSPER RCC (nivolumab in treating patients with localized kidney cancer undergoing nephrectomy), CheckMate 914 (a study comparing the combination of nivolumab and ipilimumab versus placebo in participants with localized renal cell carcinoma), KEYNOTE-564 [safety and efficacy study of pembrolizumab (MK-3475) as monotherapy in the adjuvant treatment of renal cell carcinoma post nephrectomy], or IMmotion010 [a study of atezolizumab as adjuvant therapy in participants with renal cell carcinoma (RCC) at high risk of developing metastasis following nephrectomy] trials. Kaplan-Meier and multivariable Cox regression models were used to assess the 10-year CSM rates in the overall cohort according to stage, grade, and histologic characteristics, and in 4 generated random samples according to the eligible patients for each of the 4 trials.
RESULTS
Of 116,750 patients who had undergone surgery for nmRCC, 18,559 (15.9%) had fulfilled the inclusion criteria for 1 of the 4 trials. The greatest proportion of higher stage and grade combinations and sarcomatoid histologic features would have qualified for IMmotion010, followed by KEYNOTE-564, CheckMate 914, and PROSPER RCC. Multivariable Cox regression models demonstrated the most unfavorable prognosis for stage N1 grade 3/4 (hazard ratio [HR], 11.5; P < .001), stage T4N0 grade 3/4 (HR, 9.8; P < .001), and sarcomatoid histologic features (HR, 5.5; P < .001). Among the 4 random samples, the difference in the qualifying criteria resulted in the greatest versus progressively lower CSM rates in the IMmotion010, KEYNOTE-564, CheckMate 914, and PROSPER RCC trials, respectively (P < .001).
CONCLUSIONS
Our findings indicate that participation in adjuvant immunotherapy trials should be predominantly encouraged for patients with high-grade stage T3, T4, and N1 and patients with any stage with sarcomatoid pathologic features.",2019,"Among the 4 random samples, the difference in the qualifying criteria resulted in the greatest versus progressively lower CSM rates in the IMmotion010, KEYNOTE-564, CheckMate 914, and PROSPER RCC trials, respectively (P < .001).
","['patients with localized kidney cancer undergoing', 'High-risk Nonmetastatic Renal Cell Carcinoma', '116,750 patients who had undergone surgery for nmRCC, 18,559 (15.9%) had fulfilled the inclusion criteria for 1 of the 4 trials', 'participants with localized renal cell carcinoma', 'patients with high-grade stage T3, T4, and N1 and patients with any stage with sarcomatoid pathologic features', 'From the Surveillance, Epidemiology, and End Results database (2001-2015', 'patients who had undergone surgery for nmRCC and had met the inclusion criteria for the PROSPER RCC', 'renal cell carcinoma post nephrectomy', 'participants with renal cell carcinoma (RCC) at high risk of developing metastasis following nephrectomy] trials', 'patients with high-risk nonmetastatic renal cell carcinoma (nmRCC']","['Tyrosine kinase inhibitor-based adjuvant therapy', 'pembrolizumab (MK-3475', 'atezolizumab', 'nephrectomy', 'nivolumab and ipilimumab versus placebo']","['10-year CSM rates', 'sarcomatoid histologic features', 'survival benefits', 'cancer-specific mortality (CSM', 'CSM rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475374', 'cui_str': 'T3 category'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C3660977', 'cui_str': 'MK-3475'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",116750.0,0.234096,"Among the 4 random samples, the difference in the qualifying criteria resulted in the greatest versus progressively lower CSM rates in the IMmotion010, KEYNOTE-564, CheckMate 914, and PROSPER RCC trials, respectively (P < .001).
","[{'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Palumbo', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Urology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy. Electronic address: palumbo.carlotta@gmail.com.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Mazzone', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Division of Experimental Oncology, Unit of Urology, Urological Research Institute, IRCCS San Raffaele Scientific Institute, and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Francesco A', 'Initials': 'FA', 'LastName': 'Mistretta', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Department of Urology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Knipper', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Martini Klinik, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perrotte', 'Affiliation': 'Division of Urology, University of Montreal Hospital Center, Montreal, QC, Canada.'}, {'ForeName': 'Shahrokh F', 'Initials': 'SF', 'LastName': 'Shariat', 'Affiliation': 'Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Weill Cornell Medical College, New York, NY; Department of Urology, University of Texas Southwestern Medical School, Dallas, TX; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic; Institute for Urology and Reproductive Health, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Division of Urology, University of Montreal Hospital Center, Montreal, QC, Canada.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Division of Urology, Department of Surgery, Juravinski Cancer Centre, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lattouf', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Department of Surgery, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Simeone', 'Affiliation': 'Urology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Briganti', 'Affiliation': 'Division of Experimental Oncology, Unit of Urology, Urological Research Institute, IRCCS San Raffaele Scientific Institute, and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Antonelli', 'Affiliation': 'Urology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Pierre I', 'Initials': 'PI', 'LastName': 'Karakiewicz', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Division of Urology, University of Montreal Hospital Center, Montreal, QC, Canada.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.11.010']
3171,32482570,A randomised trial comparing the subjective outcomes following septoplasty with or without inferior turbinoplasty.,"AIMS
The surgical management of contralateral inferior turbinate hypertrophy in patients with deviated nasal septum is controversial. In this randomised clinical trial, we aimed to investigate the subjective improvement of nasal symptoms postoperatively in patients undergoing septoplasty with or without inferior turbinoplasty.
MATERIAL AND METHODS
One hundred and thirty-seven patients with nasal obstruction, who had unilateral septal deviation and compensatory contralateral inferior turbinate enlargement, were randomised into either septoplasty alone arm (n=66) or septoplasty combined with turbinoplasty arm (n=71). Preoperative symptom scores and the subjective perception of the nasal obstruction were compared between two groups of the study using Nasal Obstruction Symptom Evaluation Scale (NOSE) and Visual analog scale (VAS) respectively. The measurements were repeated 6 months after surgery as well as at 1, 2, and 4 years postoperatively.
RESULTS
With regard to the findings obtained from both scales, both interventions successfully relieved the patients' complaints of nasal obstruction at almost all postoperative visits when compared with the baseline measurements (P˂0.005 for most comparisons). However, the relief of nasal obstruction was more pronounced in patients undergoing combined intervention at all postoperative visits, except at the 1st follow-up session (P˂0.005). Nasal symptoms of septoplasty alone group began to deteriorate over the period between month 24 and month 48. In contrast, patients undergoing the combined surgery steadily showed symptomatic improvement over the whole period of study.
CONCLUSIONS
A turbinate reduction surgery should be conducted along with septoplasty to achieve better results in cases suffering from deviated nasal septum with concomitant hypertrophied inferior turbinate.",2020,Preoperative symptom scores and the subjective perception of the nasal obstruction were compared between two groups of the study using Nasal Obstruction Symptom Evaluation Scale (NOSE) and Visual analog scale (VAS) respectively.,"['One hundred and thirty-seven patients with nasal obstruction, who had unilateral septal deviation and compensatory contralateral inferior turbinate enlargement', 'cases suffering from deviated nasal septum with concomitant hypertrophied inferior turbinate', 'patients with deviated nasal septum', 'patients undergoing septoplasty with or without inferior turbinoplasty']","['septoplasty with or without inferior turbinoplasty', 'septoplasty alone arm (n=66) or septoplasty combined with turbinoplasty']","['Nasal Obstruction Symptom Evaluation Scale (NOSE) and Visual analog scale (VAS', 'Preoperative symptom scores and the subjective perception of the nasal obstruction', 'relief of nasal obstruction', 'symptomatic improvement', 'Nasal symptoms', ""patients' complaints of nasal obstruction""]","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0264262', 'cui_str': 'Acquired deviated nasal septum'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4087115', 'cui_str': 'Turbinoplasty'}]","[{'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4087115', 'cui_str': 'Turbinoplasty'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",137.0,0.0328829,Preoperative symptom scores and the subjective perception of the nasal obstruction were compared between two groups of the study using Nasal Obstruction Symptom Evaluation Scale (NOSE) and Visual analog scale (VAS) respectively.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Samarei', 'Affiliation': 'Department of Otolaryngology, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: reza.samarei@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mabarian', 'Affiliation': 'Department of Otolaryngology, Urmia University of Medical Sciences, Urmia, Iran.'}]","European annals of otorhinolaryngology, head and neck diseases",['10.1016/j.anorl.2020.01.024']
3172,32482611,Aluminium salt-based antiperspirant coated prosthesis liners do not suppress local sweating during moderate intensity exercise in hot and temperate conditions.,"OBJECTIVE
To determine whether coating prosthesis liners with a 5% aluminium zirconium tetrachlorohydrate antiperspirant solution (AZCH) reduces local sweating on the thigh.
DESIGN
Double-blinded counter-balanced crossover design METHODS: Fourteen able-bodied participants (age: 28±5 y; body mass: 73.9±7.9kg, height: 1.73±0.09m; peak oxygen consumption [VO 2peak ]: 50.7±9.1 mlO 2 ⋅kg -1 ⋅min -1 ) simultaneously wore a prosthesis liner on each leg, one treated with AZCH and one untreated, for four days prior to running at 50% of VO 2peak for 60min in a temperate (23.7±0.7°C and 42.2±2.6% relative humidity) or hot (34.0±1.6°C and 40.8±6.1% relative humidity) environment. Rectal temperature (T re ) and whole-body sweat rates (WBSR) were measured to characterize thermal strain. Local sweat rate (LSR) was measured bilaterally underneath the liners, continuously, and heat-activated-sweat gland density (HASGD) was measured bilaterally every 15min.
RESULTS
In temperate condition, the mean change in T re was 1.2±0.4°C and WBSR was 723±129g⋅h -1 , whereas in the hot condition, change in T re was 1.2±0.5°C and WBSR was 911±231g⋅h -1 . In the temperate condition, AZCH treatment did not alter LSR (treated: 0.50±0.17 mg·cm -2 min -1 , untreated: 0.50±0.17 mg·cm -2 min -1 ; P=0.87) or HASGD (treated: 54±14 glands·cm -2 , untreated 55±14 glands·cm -2 ; P=0.38). In the hot condition, AZCH treatment paradoxically increased LSR (treated: 0.88±0.38 mg·cm -2 min -1 , untreated: 0.74±0.28 mg·cm -2 min -1 ; P=0.04) but not HASGD (treated: 52±17 glands·cm -2 , untreated: 48±19 glands·cm -2 ; P=0.77).
CONCLUSION
These results indicate coating prosthesis liners with 5% AZCH is ineffective at reducing local sweating.",2020,"untreated: 0.74±0.28 mg·cm -2 min -1 ; P=0.04) but not HASGD (treated: 52±17 glands·cm -2 , untreated: 48±19 glands·cm -2 ; P=0.77).
CONCLUSION
","['Fourteen able-bodied participants (age: 28±5 y; body mass: 73.9±7.9kg, height: 1.73±0.09m; peak oxygen consumption [VO 2peak ]: 50.7±9.1']","['HASGD', 'Aluminium salt-based antiperspirant coated prosthesis liners', 'coating prosthesis liners with a 5% aluminium zirconium tetrachlorohydrate antiperspirant solution (AZCH', 'AZCH']","['Local sweat rate (LSR', 'LSR', 'Rectal temperature (T re ) and whole-body sweat rates (WBSR', 'local sweating']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]","[{'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0701858', 'cui_str': 'Antiperspirants'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0043506', 'cui_str': 'Zirconium'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0257472', 'cui_str': '(5)AZCH'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",,0.0908167,"untreated: 0.74±0.28 mg·cm -2 min -1 ; P=0.04) but not HASGD (treated: 52±17 glands·cm -2 , untreated: 48±19 glands·cm -2 ; P=0.77).
CONCLUSION
","[{'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Morris', 'Affiliation': 'Thermal Ergonomics Laboratory, Faculty of Health Sciences, University of Sydney, Australia; Department of Nutrition, Exercise and Sports, Section for Integrative Physiology, University of Copenhagen, Denmark. Electronic address: nathan.morris@sydney.edu.au.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Jay', 'Affiliation': 'Thermal Ergonomics Laboratory, Faculty of Health Sciences, University of Sydney, Australia; Charles Perkins Centre, University of Sydney, Australia.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.05.012']
3173,32482616,Ticagrelor alone or conventional dual antiplatelet therapy in patients with stable or acute coronary syndromes.,"AIMS
To investigate the effect of ticagrelor monotherapy after 1-month dual antiplatelet therapy (DAPT) or conventional DAPT in patients with or without acute coronary syndrome (ACS) in the GLOBAL LEADERS Adjudication Sub-Study (GLASSY).
METHODS AND RESULTS
Risk estimates were expressed as rate ratios (RR) with 95% confidence intervals (CI). A total of3,840 ACS and 3,745 SIHD (stable ischemic heart disease) patients were included. At 2-year, rates of co-primary efficacy endpoint, composite of death, myocardial infarction, stroke or urgent target-vessel revascularization, were 7.94% in the experimental and 9.68% in the control group (RR, 0.82, 95% CI, 0.66-1.01) among ACS and 6.31% in the experimental and 7.14% in the control group (RR, 0.89, 95% CI, 0.69-1.13) among SIHD patients (Pint= 0.63). Trends for lower and higher risk of BARC 3 or 5 bleeding with the experimental strategy in ACS (2.27% vs. 3.00%, RR, 0.76, 95% CI, 0.51-1.12) and SIHD (2.70% vs. 1.96%, RR, 1.39, 95% CI, 0.91-2.12) patients, respectively, were observed with significant interaction testing (Pint=0.039). A net clinical benefit endpoint, composite of both co-primary study endpoints, favored the experimental treatment among ACS patients only.
CONCLUSIONS
Ticagrelor monotherapy after 1-month DAPT provided consistent treatment effects on ischemic endpoints in patients with or without ACS but only the former experienced a net clinical benefit. Trial registration ClinicalTrials.gov number NCT03231059.",2020,"A net clinical benefit endpoint, composite of both co-primary study endpoints, favored the experimental treatment among ACS patients only.
","['patients with stable or acute coronary syndromes', 'patients with or without acute coronary syndrome (ACS', '3,745 SIHD (stable ischemic heart disease', 'patients with or without ACS']","['Ticagrelor alone or conventional dual antiplatelet therapy', 'ticagrelor monotherapy', 'antiplatelet therapy (DAPT) or conventional DAPT']","['rate ratios (RR', 'rates of co-primary efficacy endpoint, composite of death, myocardial infarction, stroke or urgent target-vessel revascularization', 'ischemic endpoints', 'SIHD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]",,0.0916424,"A net clinical benefit endpoint, composite of both co-primary study endpoints, favored the experimental treatment among ACS patients only.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Franzone', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Eugène P', 'Initials': 'EP', 'LastName': 'McFadden', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': ''}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': ''}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ''}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': ''}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Branca', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00145']
3174,32482617,Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent: 3-Year Results of the TARGET All Comers Trial.,"AIMS
The Firehawk is a thin-strut coronary stent with a sirolimus and biodegradable polymer complex that are localized in abluminal grooves. The TARGET All Comers study found similar safety and efficacy of the Firehawk compared with the durable polymer everolimus-eluting XIENCE stent at 1- and 2-years follow-up. The aim of this study was to assess comparative clinical outcomes at 3 years.
METHODS AND RESULTS
The TARGET All Comer study is a prospective, multicenter, randomized, non-inferiority trial. A total of 1653 patients were randomly allocated to receive either the Firehawk or XIENCE stent. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization. At 3-year follow-up, TLF occurred in 11.9% in the Firehawk group and 11.5% in the XIENCE group (p=0.84). The event rates of individual components of TLF were comparable for the 2 groups. Landmark analyses between 1 and 3 years showed no significant difference of TLF for the Firehawk versus XIENCE stent. The incidence of very late definite or probable stent thrombosis was 0.8% in the Firehawk group and 1.4% in the XIENCE group (p=0.24).
CONCLUSIONS
The 3-year follow-up of the TARGET All Comers study showed comparable safety and efficacy profiles of the biodegradable polymer Firehawk and the durable polymer XIENCE stent.",2020,Landmark analyses between 1 and 3 years showed no significant difference of TLF for the Firehawk versus XIENCE stent.,['A total of 1653 patients'],"['Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent', 'Firehawk or XIENCE stent', 'XIENCE']","['safety and efficacy profiles', 'event rates of individual components of TLF', 'TLF', 'safety and efficacy', 'incidence of very late definite or probable stent thrombosis', 'target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",1653.0,0.0502199,Landmark analyses between 1 and 3 years showed no significant difference of TLF for the Firehawk versus XIENCE stent.,"[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yasin', 'Initials': 'Y', 'LastName': 'Hussain', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Schächinger', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': ''}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Lansky', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00344']
3175,32482626,Prioritisation of treatment goals among older patients with non-curable cancer: the OPTion randomised controlled trial in Dutch primary care.,"BACKGROUND
Older patients with cancer often find it difficult to take part in shared decision making.
AIM
To assess the utility of the Outcome Prioritisation Tool (OPT), designed to aid discussion with a patient in regards to their treatment goals, to empower patients with cancer through structured conversations about generic treatment goals with GPs.
DESIGN AND SETTING
A randomised controlled trial of 114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist. The intervention group used the OPT while the control group received care as usual.
METHOD
The primary outcome was patient empowerment using the score on the decision self-efficacy (DSE) scale. Secondary outcomes were symptoms measures of fatigue, anxiety, and depression. The experiences of participants were also explored.
RESULTS
No effect was found on patient empowerment between the OPT group ( n = 48; DSE 86.8; standard deviation [SD] = 18.2) and the control group ( n = 58; DSE 84.2; SD = 17.6; P = 0.47). In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%, n = 9 versus 24.1%, n = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%, n = 30 versus 77.2%, n = 44; P = 0.05). Overall, 44.8% ( n = 13) of patients indicated that the OPT-facilitated conversation helped them make a treatment decision, and 31.1% ( n = 14) of the GPs reported that they gained new insights from the conversation.
CONCLUSION
An OPT-facilitated conversation about generic treatment goals between patients and their GPs is associated with less anxiety and fatigue, but did not show statistically significant improvements in patient empowerment. Adding the OPT to routine care might ensure more patient-tailored care.",2020,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%, n = 9 versus 24.1%, n = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%, n = 30 versus 77.2%, n = 44; P = 0.05).","['Older patients with cancer', 'older patients with non-curable cancer', 'patients with cancer through structured conversations about generic treatment goals with GPs', '114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist']","['OPT while the control group received care as usual', 'Outcome Prioritisation Tool (OPT']","['symptoms measures of fatigue, anxiety, and depression', 'patient empowerment using the score on the decision self-efficacy (DSE) scale', 'mild fatigue', 'anxiety and fatigue', 'patient empowerment', 'mean anxiety scores', 'low empowerment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",114.0,0.0458868,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%, n = 9 versus 24.1%, n = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%, n = 30 versus 77.2%, n = 44; P = 0.05).","[{'ForeName': 'Mariken E', 'Initials': 'ME', 'LastName': 'Stegmann', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Brandenbarg', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'An Kl', 'Initials': 'AK', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'van Geffen', 'Affiliation': 'Department of Pulmonary Diseases, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'T Jeroen N', 'Initials': 'TJN', 'LastName': 'Hiltermann', 'Affiliation': 'Department of Pulmonary Diseases and Tuberculosis, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annette J', 'Initials': 'AJ', 'LastName': 'Berendsen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X710405']
3176,32482641,"Effects of enhanced STI partner notification counselling and provider-assisted partner services on partner referral and the incidence of STI diagnosis in Cape Town, South Africa: randomised controlled trial.","OBJECTIVES
We investigated the effects of an enhanced partner notification (PN) counselling intervention with the offer of provider-assisted referral among people diagnosed with STI in a Cape Town public clinic.
METHODS
Participants were adults diagnosed with STI at a community clinic. After the standard STI consultation, participants were randomly allocated in a 1:1:1 ratio to (1) 'HE': 20 min health education; (2) 'RR': 45 min risk reduction skills counselling; or (3) 'ePN': 45 min enhanced partner notification communication skills counselling and the offer of provider-assisted referral. The primary outcome was the incidence of repeat STI diagnoses during the 12 months after recruitment, and the secondary outcome was participants' reports 2 weeks after diagnosis of notifying recent partners. Incidence rate ratios (IRRs) were used to compare the incidence rates between arms using a Poisson regression model.
RESULTS
The sample included 1050 participants, 350 per group, diagnosed with STI between June 2014 and August 2017. We reviewed 1048 (99%) participant records, and identified 136 repeat STI diagnoses in the ePN arm, 138 in the RR arm and 141 in the HE arm. There was no difference in the annual incidence of STI diagnosis between the ePN and HE arms (IRR: 1.0; 95% CI 0.7 to 1.3), or between the RR and HE arms (IRR: 0.9; 95% CI 0.7 to 1.2). There was a greater chance of a partner being notified in the ePN condition compared with the HE condition, 64.3% compared with 53.8%, but no difference between the RR and HE arms.
CONCLUSIONS
PN counselling and education with provider-assisted services has the potential to change the behaviour of people diagnosed with STIs, increasing the number of partners they notify by more than 10%. However, these changes in behaviour did not lead to a reduction of repeat STI diagnoses.
TRIAL REGISTRATION NUMBER
PACTR201606001682364.",2020,"CONCLUSIONS
PN counselling and education with provider-assisted services has the potential to change the behaviour of people diagnosed with STIs, increasing the number of partners they notify by more than 10%.","['people diagnosed with STI in a Cape Town public clinic', 'Participants were adults diagnosed with STI at a community clinic', 'Cape Town, South Africa', 'The sample included 1050 participants, 350 per group, diagnosed with STI between June 2014 and August 2017', '1048 (99%) participant records, and identified 136 repeat STI diagnoses in the ePN arm, 138 in the RR arm and 141 in the HE arm']","['enhanced STI partner notification counselling and provider-assisted partner services', 'enhanced partner notification (PN) counselling intervention', ""HE': 20\u2009min health education; (2) 'RR': 45\u2009min risk reduction skills counselling; or (3) 'ePN': 45\u2009min enhanced partner notification communication skills counselling and the offer of provider-assisted referral""]","['annual incidence of STI diagnosis', 'incidence of repeat STI diagnoses', 'partner referral and the incidence of STI diagnosis', 'Incidence rate ratios (IRRs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0014614', 'cui_str': 'Ethyl nitrophenyl benzene thiophosphonate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0079990', 'cui_str': 'Partner Notification'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0014614', 'cui_str': 'Ethyl nitrophenyl benzene thiophosphonate'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",1050.0,0.267624,"CONCLUSIONS
PN counselling and education with provider-assisted services has the potential to change the behaviour of people diagnosed with STIs, increasing the number of partners they notify by more than 10%.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa cathy.mathews@mrc.ac.za.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South Africa Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dewing', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Banas', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Sekelwa', 'Initials': 'S', 'LastName': 'Dumile', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mdlikiva', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Thembinkosi', 'Initials': 'T', 'LastName': 'Mdlikiva', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Karen Ann', 'Initials': 'KA', 'LastName': 'Jennings', 'Affiliation': 'City Health Department of Cape Town Municipality, Cape Town, South Africa.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'City Health Department of Cape Town Municipality, Cape Town, South Africa.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Berteler', 'Affiliation': 'City of Cape Town IS&T Department, City of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Seth C', 'Initials': 'SC', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, Connecticut, USA.'}]",Sexually transmitted infections,['10.1136/sextrans-2020-054499']
3177,32482645,Tapering towards DMARD-free remission in established rheumatoid arthritis: 2-year results of the TARA trial.,"OBJECTIVES
To evaluate the 2-year clinical effectiveness of two gradual tapering strategies. The first strategy consisted of tapering the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate in ~90%), followed by the tumour necrosis factor inhibitor (TNF-inhibitor), the second strategy consisted of tapering the TNF-inhibitor first, followed by the csDMARD.
METHODS
This multicentre single-blinded randomised controlled trial included patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4 and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor. Eligible patients were randomised into gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa. The primary outcome was the number of disease flares. Secondary outcomes were DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression.
RESULTS
189 patients were randomly assigned to tapering their csDMARD (n=94) or TNF-inhibitor (n=95) first. The cumulative flare rate after 24 months was, respectively, 61% (95% CI 50% to 71%) and 62% (95% CI 52% to 72%). The patients who tapered their csDMARD first were more often able to go through the entire tapering protocol and reached DFR more often than the group that tapered the TNF-inhibitor first (32% vs 20% (p=0.12) and 21% vs 10% (p=0.07), respectively). Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
CONCLUSION
The order of tapering did not affect flare rates, DAS or HAQ-DI. DFR was achievable in 15% of patients with established RA, slightly more frequent in patients that first tapered csDMARDs. Because of similar effects from a clinical viewpoint, financial arguments may influence the decision to taper TNF-inhibitors first.",2020,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","['189 patients were randomly assigned to tapering their csDMARD (n=94) or', 'patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4\u2009and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor', 'Eligible patients']","['gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa', 'conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate', 'TNF-inhibitor']","['DFR', 'flare rates, DAS or HAQ-DI', 'DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression', 'cumulative flare rate', 'Mean DAS and HAQ-DI over time, and radiographic progression', 'number of disease flares']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",189.0,0.0797802,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'Angelique E', 'Initials': 'AE', 'LastName': 'Weel', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hazes', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Pascal Hendrik Pieter', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217485']
3178,32482668,Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial.,"INTRODUCTION
There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA). Cryotherapy is widely used in rehabilitation as an adjunct treatment due to its effects on pain and the inflammatory process. However, disagreement between KOA guidelines remains with respect to its recommendation status. The aim of this study is to verify the complementary effects of cryotherapy when associated with a tailored therapeutic exercise protocol for patients with KOA.
METHODS AND ANALYSIS
This study is a sham-controlled randomised trial with concealed allocation and intention-to-treat analysis. Assessments will be performed at baseline and immediately following the intervention period. To check for residual effects of the applied interventions, 3-month and 6-month follow-up assessments will be performed. Participants will be community members living with KOA divided into three groups: (1) the experimental group that will receive a tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol. The primary outcome will be pain intensity according to a Visual Analogue Scale. Secondary outcomes will be the Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test.
ETHICS AND DISSEMINATION
The trial was approved by the Institutional Ethics Committee of Federal University of São Carlos, São Paulo, Brazil. Registration approval number: CAAE: 65966617.9.0000.5504. The results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT03360500.",2020,There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA).,"['knee osteoarthritis', 'individuals with knee osteoarthritis (KOA', 'patients with KOA']","['Cryotherapy', 'tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol', 'Cryotherapy associated with tailored land-based exercises', 'cryotherapy']","['Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test', 'pain intensity according to a Visual Analogue Scale']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0399066', 'cui_str': 'Insertion of malleable restoration into tooth'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C4759711', 'cui_str': 'Sand'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0887882,There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA).,"[{'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Ogura Dantas', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Ana Elisa', 'Initials': 'AE', 'LastName': 'Serafim Jorge', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Regina Mendes da Silva Serrão', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Aburquerque-Sendín', 'Affiliation': 'Sociosanitary Sciences, Radiology and Physical Medicine, Universidad de Córdoba, Cordoba, Andalucía, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'de Fatima Salvini', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil tania@ufscar.br.'}]",BMJ open,['10.1136/bmjopen-2019-035610']
3179,32482669,Photobiomodulation therapy associated with supervised therapeutic exercises for people with knee osteoarthritis: a randomised controlled trial protocol.,"BACKGROUND
Physical exercise, a cornerstone of the conservative management of knee osteoarthritis (KOA), is exhaustively recommended by important clinical guidelines. A strength therapeutic exercise program (STEP) relieves pain, improves physical function and ultimately ameliorates quality of life (QoL). Furthermore, photobiomodulation (PBM) has been used as an adjunct treatment for people with KOA; however, there are still controversial recommendations regarding its use on this population. Thus, we hypothesised that PBM, when associated with a STEP protocol on patients with KOA, could induce better clinical outcomes than a STEP protocol alone.
METHODS AND ANALYSIS
The study is a 6-month triple-blind placebo-controlled randomised clinical trial with intention-to-treat analysis. The trial will include 120 people with clinic and radiographic signs of KOA. The intervention consists of a supervised STEP and PBM protocols conducted over an 8-week intervention period. Assessments are performed at baseline, right after treatment, and 3-month and 6-month follow-up periods. The primary clinical outcome is pain intensity according to a 10 cm Visual Analogue Scale. Secondary outcomes are the global Western Ontario & McMaster Universities Osteoarthritis Index; QoL assessed by the 36-item Short-Form health survey questionnaire; and performance-based physical parameters assessed by the 30 s chair stand test; the stair climb test; and the 40 m fast-paced walk test.
ETHICS AND DISSEMINATION
The trial was approved by the Human Research Ethics Committee of the Federal University of São Carlos, São Paulo, Brazil (REC no 2.016.122). Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
Brazilian Clinical Trials Registry (U1111-1215-6510).",2020,"A strength therapeutic exercise program (STEP) relieves pain, improves physical function and ultimately ameliorates quality of life (QoL).","['people with KOA', 'knee osteoarthritis (KOA', 'people with knee osteoarthritis', '120 people with clinic and radiographic signs of KOA']","['Photobiomodulation therapy', 'strength therapeutic exercise program (STEP', 'photobiomodulation (PBM', 'supervised therapeutic exercises', 'placebo']","['global Western Ontario & McMaster Universities Osteoarthritis Index; QoL assessed by the 36-item Short-Form health survey questionnaire; and performance-based physical parameters assessed by the 30 s chair stand test; the stair climb test; and the 40\u2009m fast-paced walk test', 'pain, improves physical function and ultimately ameliorates quality of life (QoL', 'pain intensity according to a 10\u2009cm Visual Analogue Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0220912', 'cui_str': 'signs'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",120.0,0.105911,"A strength therapeutic exercise program (STEP) relieves pain, improves physical function and ultimately ameliorates quality of life (QoL).","[{'ForeName': 'Ana E', 'Initials': 'AE', 'LastName': 'S Jorge', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'O Dantas', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'M S Serrão', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alburquerque-Sendín', 'Affiliation': 'Department of Sociosanitary Sciences, Radiology and Physical Medicine, Universidad de Córdoba, Instituto Maiomónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Andalucía, Spain.'}, {'ForeName': 'Tania F', 'Initials': 'TF', 'LastName': 'Salvini', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil tania@ufscar.br.'}]",BMJ open,['10.1136/bmjopen-2019-035711']
3180,32482712,"Association between Subcutaneous Adipose Tissue Inflammation, Insulin Resistance, and Calorie Restriction in Obese Females.","The worldwide epidemic of overweight and obesity has led to an increase in associated metabolic comorbidities. Obesity induces chronic low-grade inflammation in white adipose tissue (WAT). However, the function and regulation of both innate and adaptive immune cells in human WAT under conditions of obesity and calorie restriction (CR) is not fully understood yet. Using a randomized interventional design, we investigated postmenopausal overweight or obese female subjects who either underwent CR for 3 mo followed by a 4-wk phase of weight maintenance or had to maintain a stable weight over the whole study period. A comprehensive immune phenotyping protocol was conducted using validated multiparameter flow cytometry analysis in blood and s.c. WAT (SAT). The TCR repertoire was analyzed by next-generation sequencing and cytokine levels were determined in SAT. Metabolic parameters were determined by hyperinsulinemic-euglycemic clamp. We found that insulin resistance correlates significantly with a shift toward the memory T cell compartment in SAT. TCR analysis revealed a diverse repertoire in SAT of overweight or obese individuals. Additionally, whereas weight loss improved systemic insulin sensitivity in the intervention group, SAT displayed no significant improvement of inflammatory parameters (cytokine levels and leukocyte subpopulations) compared with the control group. Our data demonstrate the accumulation of effector memory T cells in obese SAT and an association between systemic glucose homeostasis and inflammatory parameters in obese females. The long-standing effect of obesity-induced changes in SAT was demonstrated by preserved immune cell composition after short-term CR-induced weight loss.",2020,"Additionally, whereas weight loss improved systemic insulin sensitivity in the intervention group, SAT displayed no significant improvement of inflammatory parameters (cytokine levels and leukocyte subpopulations) compared with the control group.","['obese females', 'Obese Females', 'postmenopausal overweight or obese female subjects who either underwent CR for 3 mo followed by a 4-wk phase of weight maintenance or had to maintain a stable weight over the whole study period']",[],"['TCR repertoire', 'inflammatory parameters (cytokine levels and leukocyte subpopulations', 'Subcutaneous Adipose Tissue Inflammation, Insulin Resistance, and Calorie Restriction', 'Metabolic parameters', 'weight loss improved systemic insulin sensitivity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0034790', 'cui_str': 'T-cell antigen receptor'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.0276917,"Additionally, whereas weight loss improved systemic insulin sensitivity in the intervention group, SAT displayed no significant improvement of inflammatory parameters (cytokine levels and leukocyte subpopulations) compared with the control group.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sbierski-Kind', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany; julia.sbierski-kind@charite.de.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Kath', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Jurisch', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Streitz', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kuchenbecker', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Babel', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Mikalai', 'Initials': 'M', 'LastName': 'Nienen', 'Affiliation': 'Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Jürchott', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Spranger', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Reiner', 'Initials': 'R', 'LastName': 'Jumpertz von Schwartzenberg', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Decker', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Krüger', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Hans-Dieter', 'Initials': 'HD', 'LastName': 'Volk', 'Affiliation': 'Berlin Institute of Health Center for Regenerative Therapies, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Department of Endocrinology and Metabolism, Berlin Institute of Health, 10178 Berlin, Germany.'}]","Journal of immunology (Baltimore, Md. : 1950)",['10.4049/jimmunol.2000108']
3181,32482970,Efficacy of Guanfacine Extended Release in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder.,"OBJECTIVE
To assess the efficacy of the non-stimulant guanfacine extended release (GXR) on attention-deficit/hyperactivity disorder (ADHD) symptoms in children and adolescents, with and without comorbid oppositional defiant disorder (ODD).
METHODS
Data were derived from 4 phase 3, randomized, placebo-controlled trials of dose-optimized GXR monotherapy, in which at least 10% of participants had a diagnosis of comorbid ODD. SPD503-312 and SPD503-316 were 10- to 13-week studies of GXR (1-7 mg/d). SPD503-314 and SPD503-307 were 8-week studies of GXR (1-4 mg/d). Efficacy was assessed using the ADHD Rating Scale IV (ADHD-RS-IV) total scores.
RESULTS
In total, 1,084 participants were included (SPD503-312 and SPD503-316, n = 537; SPD503-314, n = 333; and SPD503-307, n = 214). GXR was associated with significant improvements in ADHD core symptoms at endpoint in participants with and without ODD (p < 0.01 in all studies). Placebo-adjusted least-squares mean (95% confidence interval) changes from baseline to endpoint in the ADHD-RS-IV total scores in participants with and without ODD were -8.6 (-14.4, -2.8) and -7.3 (-9.5, -5.0) in the pooled data from SPD503-312 and SPD503-316, -12.6 (-19.6, -5.7) and -8.7 (-11.8, -5.5) in SPD503-314, and -12.7 (-17.3, -8.1) and -11.8 (-19.3, -4.4) in SPD503-307, respectively. The corresponding effect sizes were 0.688 and 0.598 in SPD503-312 and SPD503-316, 0.876 and 0.729 in SPD503-314, and 0.962 and 0.842 in SPD503-307.
CONCLUSION
The findings demonstrate the efficacy of GXR for treating ADHD in children and adolescents with comorbid ODD.",2020,GXR was associated with significant improvements in ADHD core symptoms at endpoint in participants with and without ODD (p < 0.01 in all studies).,"['children and adolescents with comorbid ODD', 'Children and Adolescents with Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder', 'Data were derived from 4 phase 3, randomized', 'children and adolescents, with and without comorbid oppositional defiant disorder (ODD', '1,084 participants were included (SPD503-312 and SPD503-316, n = 537; SPD503-314, n = 333; and SPD503-307, n = 214']","['Placebo', 'GXR monotherapy', 'Guanfacine', 'GXR', 'guanfacine extended release (GXR', 'placebo']","['Efficacy', 'ADHD-RS-IV total scores', 'ADHD core symptoms', 'ADHD Rating Scale IV (ADHD-RS-IV) total scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C4517724', 'cui_str': '333'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1084.0,0.181548,GXR was associated with significant improvements in ADHD core symptoms at endpoint in participants with and without ODD (p < 0.01 in all studies).,"[{'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Newcorn', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Huss', 'Affiliation': 'Child and Adolescent Psychiatry, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Connor', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry, University of Connecticut School of Medicine, Farmington, CT.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Hervás', 'Affiliation': 'Psiquiatría Infantil y Juvenil, University Hospital Mútua de Terrassa, Barcelona, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Werner-Kiechle', 'Affiliation': 'Shire, Zug, Switzerland.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Shire, Lexington, MA.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000822']
3182,32482999,Ephedrine versus Phenylephrine Effect on Cerebral Blood Flow and Oxygen Consumption in Anesthetized Brain Tumor Patients: A Randomized Clinical Trial.,"BACKGROUND
Studies in anesthetized patients suggest that phenylephrine reduces regional cerebral oxygen saturation compared with ephedrine. The present study aimed to quantify the effects of phenylephrine and ephedrine on cerebral blood flow and cerebral metabolic rate of oxygen in brain tumor patients. The authors hypothesized that phenylephrine reduces cerebral metabolic rate of oxygen in selected brain regions compared with ephedrine.
METHODS
In this double-blinded, randomized clinical trial, 24 anesthetized patients with brain tumors were randomly assigned to ephedrine or phenylephrine treatment. Positron emission tomography measurements of cerebral blood flow and cerebral metabolic rate of oxygen in peritumoral and normal contralateral regions were performed before and during vasopressor infusion. The primary endpoint was between-group difference in cerebral metabolic rate of oxygen. Secondary endpoints included changes in cerebral blood flow, oxygen extraction fraction, and regional cerebral oxygen saturation.
RESULTS
Peritumoral mean ± SD cerebral metabolic rate of oxygen values before and after vasopressor (ephedrine, 67.0 ± 11.3 and 67.8 ± 25.7 μmol · 100 g · min; phenylephrine, 68.2 ± 15.2 and 67.6 ± 18.0 μmol · 100 g · min) showed no intergroup difference (difference [95% CI], 1.5 [-13.3 to 16.3] μmol · 100 g · min [P = 0.839]). Corresponding contralateral hemisphere cerebral metabolic rate of oxygen values (ephedrine, 90.8 ± 15.9 and 94.6 ± 16.9 μmol · 100 g · min; phenylephrine, 100.8 ± 20.7 and 96.4 ± 17.7 μmol · 100 g · min) showed no intergroup difference (difference [95% CI], 8.2 [-2.0 to 18.5] μmol · 100 g · min [P = 0.118]). Ephedrine significantly increased cerebral blood flow (difference [95% CI], 3.9 [0.7 to 7.0] ml · 100 g · min [P = 0.019]) and regional cerebral oxygen saturation (difference [95% CI], 4 [1 to 8]% [P = 0.024]) in the contralateral hemisphere compared to phenylephrine. The change in oxygen extraction fraction in both regions (peritumoral difference [95% CI], -0.6 [-14.7 to 13.6]% [P = 0.934]; contralateral hemisphere difference [95% CI], -0.1 [- 12.1 to 12.0]% [P = 0.989]) were comparable between groups.
CONCLUSIONS
The cerebral metabolic rate of oxygen changes in peritumoral and normal contralateral regions were similar between ephedrine- and phenylephrine-treated patients. In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine. : WHAT WE ALREADY KNOW ABOUT THIS TOPIC: Phenylepherine may reduce regional cerebral oxygen saturation in anesthetized patients without cerebral pathology when compared with ephedrine WHAT THIS ARTICLE TELLS US THAT IS NEW: In adult patients with brain tumors, there were no differences in cerebral metabolic rate of oxygen in peritumoral regions or in the contralateral cerebral hemisphere after administration of ephedrine or phenylepherine.",2020,"In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.","['Anesthetized Brain Tumor Patients', 'brain tumor patients', '24 anesthetized patients with brain tumors', 'anesthetized patients without cerebral pathology', 'adult patients with brain tumors', 'anesthetized patients']","['ephedrine- and phenylephrine', 'ephedrine or phenylepherine', 'phenylephrine and ephedrine', 'phenylephrine', 'ephedrine or phenylephrine', 'Phenylephrine', 'ephedrine', 'Ephedrine']","['cerebral metabolic rate of oxygen', 'Peritumoral mean ± SD cerebral metabolic rate of oxygen values', 'Corresponding contralateral hemisphere cerebral metabolic rate of oxygen values', 'cerebral blood flow and cerebral metabolic rate of oxygen', 'cerebral blood flow and regional cerebral oxygen saturation', 'change in oxygen extraction fraction', 'Positron emission tomography measurements of cerebral blood flow and cerebral metabolic rate of oxygen', 'contralateral hemisphere difference', 'Cerebral Blood Flow and Oxygen Consumption', 'cerebral blood flow', 'regional cerebral oxygen saturation', 'cerebral metabolic rate of oxygen changes', 'changes in cerebral blood flow, oxygen extraction fraction, and regional cerebral oxygen saturation']","[{'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",24.0,0.583823,"In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.","[{'ForeName': 'Klaus U', 'Initials': 'KU', 'LastName': 'Koch', 'Affiliation': 'From the Department of Anesthesiology, Section of Neuroanesthesia (K.U.K., N.J., L.N., M.R.) Department of Nuclear Medicine and PET Center (J.A.) Department of Neurosurgery (G.v.O.) Department of Neuroradiology (L.Ø.), Aarhus University Hospital, Aarhus, Denmark Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus, Denmark (I.K.M., L.Ø.) Department of Anesthesiology, Horsens Regional Hospital, Horsens, Denmark (U.S.E.) Institute of Neuroradiology, Charité, Universitätsmedizin, Berlin, Germany (A.T.).'}, {'ForeName': 'Irene K', 'Initials': 'IK', 'LastName': 'Mikkelsen', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Aanerud', 'Affiliation': ''}, {'ForeName': 'Ulrick S', 'Initials': 'US', 'LastName': 'Espelund', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tietze', 'Affiliation': ''}, {'ForeName': 'Gorm V', 'Initials': 'GV', 'LastName': 'Oettingen', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Juul', 'Affiliation': ''}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': ''}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': ''}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003377']
3183,32483056,Acupuncture of different treatment frequency in knee osteoarthritis: a pilot randomised controlled trial.,"This 16-week randomised controlled trial (8-week treatment followed by 8-week follow-up) evaluated the symptomatic improvement in patients with knee osteoarthritis (KOA) on 3 sessions per week of acupuncture (TSWA) compared to 1 session per week of acupuncture (OSWA). Sixty participants were randomised to either the TSWA or the OSWA group in a 1:1 ratio. The primary outcome was response rate, defined as the percentage of participants achieving ≥2 points decrease on the numerical rating scale (NRS) and ≥6 points decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at week 8 compared with baseline. Additional outcomes included response rates at weeks 4 and 16, NRS, WOMAC, Patient Global Assessment (PGA), 12-item Short Form Health Survey (SF-12) and treatment credibility and expectancy. No significant difference was seen in response rate between TSWA and OSWA groups at week 8 (64.7% vs. 50.0%; difference, 14.7 percentage points [95% CI, -10.1 to 39.4 percentage points], P=0.435). At weeks 4 and 16, the TSWA group had higher response rates than OSWA group (week-4: difference, 44.7 percentage points [95% CI, 23.2 to 66.1 percentage points], P=0.001; week-16: difference, 46.0 percentage points [95% CI, 24.4 to 67.6 percentage points], P<0.001). Participants in TSWA group experienced significantly greater improvements in NRS, WOMAC function and PGA than OSWA group. There were no significant between-group differences in WOMAC stiffness and SF-12. In summary, TSWA immediately improved knee pain and dysfunction compared with OSWA. In addition, the benefit of TSWA persists throughout follow-up.",2020,"Participants in TSWA group experienced significantly greater improvements in NRS, WOMAC function and PGA than OSWA group.","['knee osteoarthritis', 'Sixty participants', 'patients with knee osteoarthritis (KOA']","['OSWA', 'acupuncture (OSWA', 'Acupuncture', 'TSWA', 'acupuncture (TSWA']","['response rate, defined as the percentage of participants achieving ≥2 points decrease on the numerical rating scale (NRS) and ≥6 points decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score', 'response rates', 'response rates at weeks 4 and 16, NRS, WOMAC, Patient Global Assessment (PGA), 12-item', 'knee pain and dysfunction', 'NRS, WOMAC function and PGA', 'response rate', 'WOMAC stiffness and SF-12']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",60.0,0.126622,"Participants in TSWA group experienced significantly greater improvements in NRS, WOMAC function and PGA than OSWA group.","[{'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Lin', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, Beijing, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jin-Ling', 'Initials': 'JL', 'LastName': 'Li', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jia-Kai', 'Initials': 'JK', 'LastName': 'Shao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}]",Pain,['10.1097/j.pain.0000000000001940']
3184,32483058,"Effects of hypnosis, cognitive therapy, hypnotic cognitive therapy, and pain education in adults with chronic pain: a randomized clinical trial.","Chronic pain is a significant health problem worldwide with limited pharmacological treatment options. This study evaluated the relative efficacy of four treatment sessions each of four non-pharmacological treatments: (1) hypnotic cognitive therapy (using hypnosis to alter the meaning of pain); (2) standard cognitive therapy; (3) hypnosis focused on pain reduction, and (4) pain education. One hundred seventy-three individuals with chronic pain were randomly assigned to receive four sessions of one of the four treatments. Primary (pain intensity) and secondary outcome measures were administered by assessors unaware of treatment allocation at pre-treatment, post-treatment, and 3-, 6- and 12-month follow-up. Treatment effects were evaluated using ANOVA, a generalized estimating equation approach, or a Fisher Exact Test, depending on the outcome domain examined. All four treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months post-treatment. Pre- to post-treatment improvements were observed across the four treatment conditions on the secondary outcomes of pain interference and depressive symptoms, with some return towards pre-treatment levels at 12-months follow-up. No significant between group differences emerged in omnibus analyses, and few statistically significant between-group differences emerged in the planned pairwise analyses, although the two significant effects that did emerge favored hypnotic cognitive therapy. Future research is needed to determine if the significant differences that emerged are reliable.",2020,All four treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months post-treatment.,"['adults with chronic pain', 'One hundred seventy-three individuals with chronic pain']","['hypnosis, cognitive therapy, hypnotic cognitive therapy, and pain education', 'hypnotic cognitive therapy', 'standard cognitive therapy; (3) hypnosis focused on pain reduction, and (4) pain education', 'Pre']","['hypnotic cognitive therapy', 'pain intensity', 'pain interference and depressive symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",173.0,0.0592179,All four treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months post-treatment.,"[{'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'University of Washington.'}, {'ForeName': 'M Elena', 'Initials': 'ME', 'LastName': 'Mendoza', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'University of Washington.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Patterson', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Ivan R', 'Initials': 'IR', 'LastName': 'Molton', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Tiara M', 'Initials': 'TM', 'LastName': 'Dillworth', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Gertz', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Hakimian', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Battalio', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Marcia A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'University of Washington.'}]",Pain,['10.1097/j.pain.0000000000001943']
3185,32483059,Effects of 4 Weeks of Active Exergames Training on Muscular Fitness in Elderly Women.,"Gallardo-Meza, C, Simon, K, Bustamante-Ara, N, Ramirez-Campillo, R, García-Pinillos, F, Keogh, JWL, and Izquierdo, M. Effects of 4 weeks of active exergames training on muscular fitness in elderly women. J Strength Cond Res XX(X): 000-000, 2020-To analyze the effects of 4 weeks of an active exergames training program on muscular fitness in older women, 2 groups of community dwelling physically active subjects were formed by block-design randomization. One was deemed the control group (CG, n = 37; age 68.1 ± 3.3 years), and a second group completed 4 weeks of an active exergames training program (ExG, n = 35; age, 69.2 ± 3.7 years). Training included active exergames (Wii Fit Plus) performed on the Wii Balanceboard, 2 sessions per week. The exergames required mainly balance-related movements, such as leaning forward, leftward, and rightward, also requiring isometric squat positions and explosive leg extension. A supervisor-to-subject ratio method of 2:1 was used. An intensity-based individual progressive overload was applied. There were no significant (all p > 0.05, d = 0.01-0.07) baseline differences between-groups for all dependent variables. For the ExG, significant improvements were observed in static balance right leg test (Δ75.5%, d = 0.89), static balance left leg (Δ33.7%, d = 0.57), timed up-and-go test (Δ14.8%, d = 0.85) and sit-to-stand velocity test (Δ83.8%, d = 1.62). For the control group, trivial to small decrements in performance were observed across all tests (Δ -2.1 to -8.4%, d = -0.08 to 0.32). Group × time interactions were observed for the static balance right and left leg, timed up-and-go test, and the mean velocity achieved in the 5-repetition sit-to-stand test (all p < 0.001; d = 0.33-0.60). In conclusion, exergames training improves muscular fitness in older women. These results should be considered when designing appropriate and better exercise training programs for older women.",2020,"Group × time interactions were observed for the static balance right and left leg, timed up-and-go test, and the mean velocity achieved in the 5-repetition sit-to-stand test (all p < 0.001; d = 0.33-0.60).","['older women', 'Elderly Women', 'older women, 2 groups of community dwelling physically active subjects', 'elderly women']","['Active Exergames Training', 'J Strength Cond Res XX(X', 'active exergames training', 'exergames training', 'active exergames training program']","['Muscular Fitness', 'static balance right leg test', 'mean velocity achieved in the 5-repetition sit-to-stand test', 'muscular fitness', 'static balance left leg', 'static balance right and left leg']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0230415', 'cui_str': 'Structure of right lower limb'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]",37.0,0.0166769,"Group × time interactions were observed for the static balance right and left leg, timed up-and-go test, and the mean velocity achieved in the 5-repetition sit-to-stand test (all p < 0.001; d = 0.33-0.60).","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Gallardo-Meza', 'Affiliation': 'School of Kinesiology, University Santo Tomas, Osorno, Chile.'}, {'ForeName': 'Kristel', 'Initials': 'K', 'LastName': 'Simon', 'Affiliation': 'School of Kinesiology, University Santo Tomas, Osorno, Chile.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Bustamante-Ara', 'Affiliation': 'Autonomous University of Chile, Talca, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Laboratory of Human Performance, Quality of Life and Wellness Research Group, Department of Physical Activity Sciences, University of Los Lagos, Osorno, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'García-Pinillos', 'Affiliation': 'Department of Physical Education, Sports and Recreation, University of La Frontera, Temuco, Chile.'}, {'ForeName': 'Justin W L', 'Initials': 'JWL', 'LastName': 'Keogh', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'GICAEDS Group, Physical Culture, Sports and Recreation Program, University of Santo Tomás, Bogotá, D.C Colombia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003560']
3186,32483061,"The Effects of 6 Weeks Eccentric Training on Speed, Dynamic Balance, Muscle Strength, Power, and Lower Limb Asymmetry in Prepubescent Weightlifters.","Hammami, R, Duncan, MJ, Nebigh, A, Werfelli, H, and Rebai, H. The effects of 6 weeks eccentric training on speed, dynamic balance, muscle strength, power and lower limb asymmetry in prepubescent weightlifters. J Strength Cond Res XX(X): 000-000, 2020-This study examined whether 6 weeks of twice-weekly in-season hamstring eccentric training would enhance selected performance-related abilities in prepubescent male weightlifters. Twenty elite weightlifters (11.1 ± 0.8 years) were randomly split into an eccentric training intervention group (INT n = 10) or a control group (CON) that maintained their standard in-season regimen (n = 10). Pre-intervention and postintervention speed, dynamic balance, muscle strength, power, and lower limb (LL) asymmetry were assessed. Analysis of covariance controlling for maturation was used to determine any differences in the performance variables. There were no significant changes in muscle strength, dynamic balance, or LL asymmetry (all p < 0.05) because of the intervention. Both 10-m (p = 0.001) and 30-m (p = 0.007) sprint speed and agility (p = 0.049) improved to a greater extent in INT compared with the CON group. Similar results were evident for the standing long jump (p = 0.015) and 3 hop test (p = 0.004) where performance improved to a greater magnitude in INT compared with CON groups. This study suggests that eccentric training, undertaken twice weekly for 6-weeks results in positive changes in sprint speed, change of direction speed, and power performance, but not muscle strength, dynamic balance, or LL asymmetry in prepubertal weightlifters.",2020,"There were no significant changes in muscle strength, dynamic balance, or LL asymmetry (all p < 0.05) because of the intervention.","['Prepubescent Weightlifters', 'prepubescent weightlifters', 'prepubertal weightlifters', 'Twenty elite weightlifters (11.1 ± 0.8 years', 'prepubescent male weightlifters']","['J Strength Cond Res XX(X', '6 Weeks Eccentric Training', 'season hamstring eccentric training', 'eccentric training', 'eccentric training intervention group (INT n = 10) or a control group (CON) that maintained their standard in-season regimen', 'CON']","['sprint speed, change of direction speed, and power performance, but not muscle strength, dynamic balance, or LL asymmetry', 'Hammami, R, Duncan, MJ, Nebigh, A, Werfelli, H, and Rebai, H', 'speed, dynamic balance, muscle strength, power and lower limb asymmetry', 'standing long jump', 'muscle strength, dynamic balance, or LL asymmetry', 'Speed, Dynamic Balance, Muscle Strength, Power, and Lower Limb Asymmetry', 'Pre-intervention and postintervention speed, dynamic balance, muscle strength, power, and lower limb (LL) asymmetry']","[{'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0023221', 'cui_str': 'Leg length inequality'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}]",,0.0136686,"There were no significant changes in muscle strength, dynamic balance, or LL asymmetry (all p < 0.05) because of the intervention.","[{'ForeName': 'Raouf', 'Initials': 'R', 'LastName': 'Hammami', 'Affiliation': 'Research Unit, ""Education, Motricity, Sports and Health"" (UR 15JS01), Higher Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Center for Sport, Exercise and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Nebigh', 'Affiliation': 'Research Unit, ""Education, Motricity, Sports and Health"" (UR 15JS01), Higher Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Hanen', 'Initials': 'H', 'LastName': 'Werfelli', 'Affiliation': 'Research Unit, ""Education, Motricity, Sports and Health"" (UR 15JS01), Higher Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'Research Unit, ""Education, Motricity, Sports and Health"" (UR 15JS01), Higher Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003598']
3187,32483072,Outcomes of Resident-Performed Laser-Assisted vs Traditional Phacoemulsification.,"PURPOSE
To compare the effectiveness of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification cataract surgery (CPS) by resident surgeons.
SETTING
Parkland Memorial Health and Hospital System, Dallas, Texas, U.S.A.
DESIGN
Prospective randomized study.
METHODS
All surgeries to be performed by PGY-3 & 4 residents from October 2015 through June 2017 were eligible for inclusion. Patients were required to complete a post-op day 1, week 1, month 1, and month 3 visit. Specular microscopy was performed preoperatively and post-operatively. Surgeries were filmed and each step timed and compared. Surgeon and patient surveys were filled out post-operatively.
RESULTS
Of the 135 eyes of 96 subjects enrolled in the study, 64 eyes received FLACS and 71 eyes received CPS. There was no significant difference in best corrected visual acuity (BCVA), either preoperatively or at the postop day 1, week 1, month 1, or month 3 visits (P= 0.469, 0.539, 0.701, 0.777, and 0.777 respectively). Cumulated dissipated energy and irrigation fluid usage were not different between FLACS and CPS (P-values 0.521 and 0.368), nor was there a difference n the reduction of endothelial cell counts after surgery (P=0.881). Wound creation (P=0.014), cortical cleanup (P=0.009) and IOL implantation (P=0.031) were faster in the CPS group. Survey results indicated that the overall patient experience was similar for FLACS and CPS.
CONCLUSION
This first prospective randomized trial evaluating resident-performed FLACS shows that, in resident hands, FLACS provides similar results to CPS with regards to visual acuity, endothelial cell loss, operative time, patient satisfaction, and surgical complication rate.",2020,"There was no significant difference in best corrected visual acuity (BCVA), either preoperatively or at the postop day 1, week 1, month 1, or month 3 visits (P= 0.469, 0.539, 0.701, 0.777, and 0.777 respectively).","['All surgeries to be performed by PGY-3 & 4 residents from October 2015 through June 2017 were eligible for inclusion', 'Of the 135 eyes of 96 subjects enrolled in the study, 64 eyes received']","['Resident-Performed Laser-Assisted vs Traditional Phacoemulsification', 'CPS', 'conventional phacoemulsification cataract surgery (CPS', 'FLACS', 'femtosecond laser-assisted cataract surgery (FLACS']","['IOL implantation', 'Cumulated dissipated energy and irrigation fluid usage', 'best corrected visual acuity (BCVA', 'visual acuity, endothelial cell loss, operative time, patient satisfaction, and surgical complication rate', 'endothelial cell counts', 'cortical cleanup', 'Wound creation']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}]","[{'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0441513', 'cui_str': 'Construction'}]",96.0,0.0403187,"There was no significant difference in best corrected visual acuity (BCVA), either preoperatively or at the postop day 1, week 1, month 1, or month 3 visits (P= 0.469, 0.539, 0.701, 0.777, and 0.777 respectively).","[{'ForeName': 'Brock', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'From the Department of Ophthalmology, The University of Texas Southwestern Medical Center, Dallas, Texas, U.S.A.'}, {'ForeName': 'Preston H', 'Initials': 'PH', 'LastName': 'Blomquist', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ririe', 'Affiliation': ''}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Pouly', 'Affiliation': ''}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'W Matthew', 'Initials': 'WM', 'LastName': 'Petroll', 'Affiliation': ''}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'McCulley', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000253']
3188,32483076,Comparison of the rotational stability between plate-haptic toric and C-loop haptic toric intraocular lenses in myopic eyes.,"PURPOSE
To compare the rotational stability of a plate-haptic toric intraocular lens (IOL) versus a C-loop haptic toric IOL in myopic cataract eyes.
SETTING
EENT Hospital of Fudan University, China.
DESIGN
Prospective, randomized, controlled study.
METHODS
Cataract eyes with axial length (AXL)>24.5 mm were randomly assigned to receive implantation of a C-loop haptic toric IOL (AcrySof Toric IOL, Group A) or a plate-haptic toric IOL (AT TORBI 709M, Group B). IOL rotation, residual astigmatism (RAS), visual acuity and high-order aberrations (HOAs) evaluated with OPD-Scan III aberrometer were compared at 3 months postoperatively. In total, 62 eyes of 62 patients were eligible for analysis: 31 in Group A and 31 in Group B.
RESULTS
The mean rotation of toric IOLs was greater in Group A than in Group B (8.00±3.60° vs 4.42±3.24°, respectively, p<0.001), especially when IOLs were vertically placed. IOL rotation was positively correlated with AXL in Group A while no such correlations were found in Group B. RAS in Group A was greater than that in Group B (-0.76±0.30D vs -0.51±0.29D, respectively, p=0.001). Fewer eyes achieved a RAS of ≤0.50D in Group A than in Group B (38.71% vs 64.52%). Group A had worse postoperative uncorrected visual acuity and higher total HOAs and coma for a 6mm pupil than Group B, while postoperative corrected visual acuity was not different between the two groups.
CONCLUSIONS
The plate-haptic toric IOL may be a better choice for myopic cataract eyes with corneal astigmatism due to reduced postoperative rotation.",2020,"The mean rotation of toric IOLs was greater in Group A than in Group B (8.00±3.60° vs 4.42±3.24°, respectively, p<0.001), especially when IOLs were vertically placed.","['myopic eyes', 'In total, 62 eyes of 62 patients were eligible for analysis: 31 in Group A and 31 in Group B', 'EENT Hospital of Fudan University, China', 'Cataract eyes with axial length', 'myopic cataract eyes']","['implantation of a C-loop haptic toric IOL (AcrySof Toric IOL, Group A) or a plate-haptic toric IOL (AT TORBI', 'plate-haptic toric intraocular lens (IOL) versus a C-loop haptic toric IOL', 'plate-haptic toric and C-loop haptic toric intraocular lenses']","['mean rotation of toric IOLs', 'IOL rotation', 'IOL rotation, residual astigmatism (RAS), visual acuity and high-order aberrations (HOAs) evaluated with OPD-Scan III aberrometer', 'postoperative corrected visual acuity', 'postoperative uncorrected visual acuity and higher total HOAs and coma']","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C3203722', 'cui_str': 'Residual astigmatism'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1532954', 'cui_str': 'Wavefront analyzer'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009421', 'cui_str': 'Coma'}]",62.0,0.0813194,"The mean rotation of toric IOLs was greater in Group A than in Group B (8.00±3.60° vs 4.42±3.24°, respectively, p<0.001), especially when IOLs were vertically placed.","[{'ForeName': 'Xiangjia', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Eye Institute, Eye and Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Eye Institute, Eye and Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Eye Institute, Eye and Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xianfang', 'Initials': 'X', 'LastName': 'Rong', 'Affiliation': 'Eye Institute, Eye and Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Eye Institute, Eye and Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000259']
3189,32483079,Impact of Personal Protective Equipment on Pediatric Cardiopulmonary Resuscitation Performance: A Controlled Trial.,"OBJECTIVES
This study aimed to determine whether personal protective equipment (PPE) results in deterioration in chest compression (CC) quality and greater fatigue for administering health care providers (HCPs).
METHODS
In this multicenter study, HCPs completed 2 sessions. In session 1 (baseline), HCPs wore normal attire; in session 2, HCPs donned full PPE. During each session, they performed 5 minutes of uninterrupted CCs on a child manikin. Chest compression rate, depth, and release velocity were reported in ten 30-second epochs. Change in CC parameters and self-reported fatigue were measured between the start and 2- and 5-minute epochs.
RESULTS
We enrolled 108 HCPs (prehospital and in-hospital providers). The median CC rate did not change significantly between epochs 1 and 10 during baseline sessions. Median CC depth and release velocity decreased for 5 minutes with PPE. There were no significant differences in CC parameters between baseline and PPE sessions in any provider group. Median fatigue scores during baseline sessions were 2 (at start), 4 (at 2 minutes), and 6 (at 5 minutes). There was a significantly higher median fatigue score between 0 and 5 minutes in both study sessions and in all groups. Fatigue scores were significantly higher for providers wearing PPE compared with baseline specifically among prehospital providers.
CONCLUSIONS
During a clinically appropriate 2-minute period, neither CC quality nor self-reported fatigue worsened to a significant degree in providers wearing PPE. Our data suggest that Pediatric Basic Life Support recommendations for CC providers to switch every 2 minutes need not be altered with PPE use.",2020,"During a clinically appropriate 2-minute period, neither CC quality nor self-reported fatigue worsened to a significant degree in providers wearing PPE.","['Pediatric Cardiopulmonary Resuscitation Performance', 'We enrolled 108 HCPs (prehospital and in-hospital providers']","['Personal Protective Equipment', 'personal protective equipment (PPE']","['Chest compression rate, depth, and release velocity', 'Median CC depth and release velocity', 'median fatigue score', 'CC parameters', 'Change in CC parameters and self-reported fatigue', 'Fatigue scores', 'median CC rate', 'Median fatigue scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",108.0,0.037549,"During a clinically appropriate 2-minute period, neither CC quality nor self-reported fatigue worsened to a significant degree in providers wearing PPE.","[{'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Donoghue', 'Affiliation': 'From the Departments of Anesthesia and Critical Care Medicine.'}, {'ForeName': 'Maybelle', 'Initials': 'M', 'LastName': 'Kou', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Good', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Eiger', 'Affiliation': ""Clinical and Organizational Development, Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nash', 'Affiliation': 'Fairfax County Fire and Rescue Department, Hazardous Materials Response Team, Fairfax, VA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Henretig', 'Affiliation': 'Pediatrics, Perelman School of Medicine at the University of Pennsylvania.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stacks', 'Affiliation': 'Inova Center for Advanced Medical Simulation, Inova Fairfax Medical Campus, Falls Church, VA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kochman', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Debski', 'Affiliation': 'The Emmes Company, Rockville, MD.'}, {'ForeName': 'Jia-Yuh', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'The Emmes Company, Rockville, MD.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'The Emmes Company, Rockville, MD.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Gosnell', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Siegel', 'Affiliation': 'Eunice Kennedy Shriver National Institute for Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Krug', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Adler', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric emergency care,['10.1097/PEC.0000000000002109']
3190,32478400,"The depot GnRH agonist protocol improves the live birth rate per fresh embryo transfer cycle, but not the cumulative live birth rate in normal responders: a randomized controlled trial and molecular mechanism study.","STUDY QUESTION
Do cumulative live birth rates (CLBRs) after one complete ART cycle differ between the three commonly used controlled ovarian stimulation (COS) protocols (GnRH antagonist, depot GnRHa (GnRH agonist) and long GnRHa) in normal responders undergoing IVF/ICSI?
SUMMARY ANSWER
There were similar CLBRs between the GnRH antagonist, depot GnRHa and long GnRHa protocols.
WHAT IS KNOWN ALREADY
There is no consensus on which COS protocol is the most optimal in women with normal ovarian response. The CLBR provides the final success rate after one complete ART cycle, including the fresh and all subsequent frozen-thawed embryo transfer (ET) cycles. We suggest that the CLBR measure would allow for better comparisons between the different treatment protocols.
STUDY DESIGN, SIZE, DURATION
A prospective controlled, randomized, open label trial was performed between May 2016 and May 2017. A total of 819 patients were allocated to the GnRH antagonist, depot GnRHa or long GnRHa protocol in a 1:1:1 ratio. The minimum follow-up time from the first IVF cycle was 2 years. To further investigate the potential effect of COS with the GnRH antagonist, depot GnRHa or long GnRHa protocol on endometrial receptivity, the expression of homeobox A10 (HOXA10), myeloid ecotropic viral integration site 1 (MEIS1) and leukemia inhibitory factor (LIF) endometrial receptivity markers was evaluated in endometrial tissue from patients treated with the different COS protocols.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Infertile women with normal ovarian response (n = 819) undergoing IVF/ICSI treatment were randomized to the GnRH antagonist, depot GnRHa or long GnRHa protocol. Both IVF and ICSI cycles were included, and the sperm samples used were either fresh or frozen partner ejaculates or frozen donor ejaculates. The primary outcome was the live birth rate (LBR) per fresh ET cycle, and the CLBR after one complete ART cycle, until the birth of a first child (after 28 weeks) or until all frozen embryos were used, whichever occurred first. Pipelle endometrial biopsies from 34 female patients were obtained on Days 7-8 after oocyte retrieval or spontaneous ovulation in natural cycles, respectively, and HOXA10, MEIS1 and LIF mRNA and protein expression levels in the human endometrium was determined by quantitative real-time PCR and western blot, respectively.
MAIN RESULTS AND THE ROLE OF CHANCE
There were no significant differences in CLBRs between the GnRH antagonist, depot GnRHa or long GnRHa protocol (71.4 versus 75.5 versus 72.2%, respectively). However, there was a significantly higher LBR per fresh ET cycle in the depot GnRHa protocol than in the long GnRHa and GnRH antagonist protocols (62.6 versus 52.1% versus 45.6%, P < 0.05). Furthermore, HOXA10, MEIS1 and LIF mRNA and protein expression in endometrium all showed significantly higher in the depot GnRHa protocol than in the long GnRHa and GnRH antagonist protocols (P < 0.05).
LIMITATIONS, REASONS FOR CAUTION
A limitation of our study was that both our clinicians and patients were not blinded to the randomization for the randomized controlled trial (RCT). An inclusion criterion for the current retrospective cohort study was based on the 'actual ovarian response' during COS treatment, while the included population for the RCT was 'expected normal responders' based on maternal age and ovarian reserve test. In addition, the analysis was restricted to patients under 40 years of age undergoing their first IVF cycle. Furthermore, the endometrial tissue was collected from patients who cancelled the fresh ET, which may include some patients at risk for ovarian hyperstimulation syndrome, however only patients with 4-19 oocytes retrieved were included in the molecular study.
WIDER IMPLICATIONS OF THE FINDINGS
The depot GnRH agonist protocol improves the live birth rate per fresh ET cycle, but not the cumulative live birth rate in normal responders. A possible explanation for the improved LBR after fresh ET in the depot GnRHa protocol could be molecular signalling at the level of endometrial receptivity.
STUDY FUNDING/COMPETING INTEREST(S)
This project was funded by Grant 81571439 from the National Natural Sciences Foundation of China and Grant 2016YFC1000206-5 from the National Key Research & Development Program of China. The authors declare no conflict of interest.
TRIAL REGISTRATION NUMBER
The RCT trial was registered at the Chinese Clinical Trial Registry, Study Number: ChiCTR-INR-16008220.
TRIAL REGISTRATION DATE
5 April 2016.
DATE OF FIRST PATIENT’S ENROLLMENT
12 May 2016.",2020,"There were no significant differences in CLBRs between the GnRH antagonist, depot GnRHa or long GnRHa protocol (71.4 versus 75.5 versus 72.2%, respectively).","['endometrial tissue from patients treated with the different COS protocols', 'Infertile women with normal ovarian response (n\u2009=\u2009819) undergoing IVF/ICSI treatment', '819 patients', 'patients under 40\xa0years of age undergoing their first IVF cycle', '’S', 'women with normal ovarian response', '34 female patients', 'patients with 4-19 oocytes retrieved were included in the molecular study', 'normal responders undergoing IVF/ICSI']","['GnRH antagonist, depot GnRHa or long GnRHa protocol', 'controlled ovarian stimulation (COS) protocols (GnRH antagonist, depot GnRHa (GnRH agonist) and long GnRHa']","['endometrial receptivity, the expression of homeobox A10 (HOXA10), myeloid ecotropic viral integration site 1 (MEIS1) and leukemia inhibitory factor (LIF) endometrial receptivity markers', 'live birth rate per fresh embryo transfer cycle', 'CLBRs', 'live birth rate (LBR) per fresh ET cycle, and the CLBR after one complete ART cycle, until the birth of a first child', 'Furthermore, HOXA10, MEIS1 and LIF mRNA and protein expression in endometrium', 'LBR per fresh ET cycle', 'live birth rate per fresh ET cycle', 'HOXA10, MEIS1 and LIF mRNA and protein expression levels', 'cumulative live birth rate']","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C4760174', 'cui_str': 'HOXA 10 Proteins'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0085224', 'cui_str': 'Integration, Virus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0125606', 'cui_str': 'Cholinergic Differentiation Factor'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",819.0,0.172986,"There were no significant differences in CLBRs between the GnRH antagonist, depot GnRHa or long GnRHa protocol (71.4 versus 75.5 versus 72.2%, respectively).","[{'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Geerts', 'Affiliation': 'Department of Medical Biology, Amsterdam University Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Shiqiao', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yue', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Guijin', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': ""Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, 1095 JieFang Avenue, Wuhan 430030, People's Republic of China.""}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa086']
3191,32478474,Tofacitinib in the treatment of Indian patients with rheumatoid arthritis: A post hoc analysis of efficacy and safety in Phase 3 and long-term extension studies over 7 years.,"OBJECTIVES
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized tofacitinib efficacy/safety in Indian vs rest of the world (ROW; excluding India) RA patients.
METHODS
Efficacy data were pooled for disease-modified antirheumatic drug (DMARD) inadequate responders from Phase (P)3 studies. For Indian patients, ORAL Solo and ORAL Scan; ROW (excluding India), these studies plus ORAL Step, ORAL Sync, and ORAL Standard. Safety data also included ORAL Start (P3; methotrexate-naïve) and ORAL Sequel (long-term extension [LTE] study; data cut-off March 2017) for Indian patients, and these studies plus A3921041 (LTE study; Japanese study) for ROW. Efficacy outcomes at months 3/6: American College of Rheumatology (ACR)20/50/70; Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission/low disease activity; change from baseline in Health Assessment Questionnaire-Disability Index. Incidence rates (IRs; patients with events/100 patient-years) for adverse events of special interest (AESIs) were assessed throughout. Descriptive data underwent no formal comparison.
RESULTS
One-hundred-and-ninety-seven Indian and 3879 ROW patients were included. Compared with ROW patients, Indian patients were younger, had lower body mass index, shorter RA duration, and higher baseline disease activity; most Indian patients were non-smokers and all were biologic DMARD (bDMARD)-naïve. Month 3 ACR20 rates with tofacitinib 5 mg twice daily/10 mg twice daily/placebo were 67.4%/82.1%/40.9% (India) and 59.0%/66.1%/28.2% (ROW), and month 6 rates were 76.2%/92.1%/88.9% (India) and 69.0%/74.2%/66.5% (ROW). Month 3/6 improvements in other outcomes were generally numerically greater with tofacitinib vs placebo, and similar in both populations. Compared with ROW, Indian patients had numerically fewer AEs/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR = 1.21; 95% CI 0.49, 2.49) vs ROW patients (IR = 0.17; 95% CI 0.11, 0.25).
CONCLUSIONS
Tofacitinib efficacy/safety were similar in both populations, except TB IR, which was higher in Indian patients but in line with those in bDMARD-treated RA patients from high-risk countries (IR = 0.00-2.56; TB IR >0.05 [World Health Organization]). Limitations included the small Indian population and baseline differences between populations.",2020,"Compared with ROW, Indian patients had numerically fewer AEs/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR = 1.21; 95% CI 0.49, 2.49) vs ROW patients (IR = 0.17; 95% CI 0.11, 0.25).
","['Indian vs rest of the world (ROW; excluding India) RA patients', 'Indian patients with rheumatoid arthritis', 'Indian patients, and these studies plus A3921041 (LTE study; Japanese study) for ROW', 'disease-modified antirheumatic drug\xa0(DMARD) inadequate responders from Phase (P)3 studies', 'rheumatoid arthritis (RA', 'One-hundred-and-ninety-seven Indian and 3879 ROW patients were included']","['placebo', 'Tofacitinib', 'ORAL Start (P3; methotrexate-naïve) and ORAL Sequel (long-term extension [LTE', 'tofacitinib 5\xa0mg twice daily/10']","['ACR20 rates', 'tuberculosis (TB) IR', 'adverse events of special interest (AESIs', 'lower body mass index, shorter RA duration, and higher baseline disease activity', 'Incidence rates', 'biologic DMARD (bDMARD)-naïve', 'Tofacitinib efficacy/safety', 'Health Assessment Questionnaire-Disability Index']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0064855', 'cui_str': 'Leukotriene E'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0064855', 'cui_str': 'Leukotriene E'}, {'cui': 'C3505040', 'cui_str': 'tofacitinib 5 MG'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.170653,"Compared with ROW, Indian patients had numerically fewer AEs/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR = 1.21; 95% CI 0.49, 2.49) vs ROW patients (IR = 0.17; 95% CI 0.11, 0.25).
","[{'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Chopra', 'Affiliation': 'Arthritis Research and Care Foundation, Center for Rheumatic Diseases, Pune, India.'}, {'ForeName': 'Vineeta', 'Initials': 'V', 'LastName': 'Shobha', 'Affiliation': ""St. John's Medical College Hospital, Bangalore, India.""}, {'ForeName': 'Srikantiah', 'Initials': 'S', 'LastName': 'Chandrashekara', 'Affiliation': 'ChanRe Rheumatology & Immunology Center & Research, Bangalore, India.'}, {'ForeName': 'Sarath C M', 'Initials': 'SCM', 'LastName': 'Veeravalli', 'Affiliation': 'Krishna Institute of Medical Sciences, Hyderabad, India.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Swastik Rheumatology Clinic, Ahmedabad, India.'}, {'ForeName': 'Uppuluri R', 'Initials': 'UR', 'LastName': 'Rao', 'Affiliation': 'Sri Deepti Rheumatology Center, Hyderabad, India.'}, {'ForeName': 'Sapan', 'Initials': 'S', 'LastName': 'Pandya', 'Affiliation': 'Rheumatic Diseases Clinic, Vedanta Institute of Medical Science, Ahmedabad, India.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Wagh', 'Affiliation': 'Jehangir Clinical Development Center, Maharashtra, India.'}, {'ForeName': 'Jugal K', 'Initials': 'JK', 'LastName': 'Kadel', 'Affiliation': 'Mahavir Hospital & Research Center, Hyderabad, India.'}, {'ForeName': 'Amit V', 'Initials': 'AV', 'LastName': 'Thorat', 'Affiliation': 'Pfizer Australia, Sydney, NSW, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Adhav', 'Affiliation': 'Pfizer Inc, Mumbai, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Santos Estrella', 'Affiliation': 'Pfizer Inc, Makati City, Philippines.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Pfizer Inc, Beijing, China.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Wouters', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}]",International journal of rheumatic diseases,['10.1111/1756-185X.13853']
3192,32478616,Immediate changes in post-stroke gait using a shoe lift on the nonaffected lower limb: A preliminary study.,"INTRODUCTION
Gait impairment is one of the most important post-stroke complications and is associated with reduced mobility, limitations in activities of daily living and decreased quality of life. Gait recovery is an important goal in post-stroke rehabilitation and shoe lifts have been used on the nonaffected lower limb (NLL) to reduce compensatory strategies such as vaulting, pelvic hiking and hip circumduction during the swing phase of the affected lower limb. Moreover, in clinical practice shoe lifts seem to reduce tripping and the risk of falls.
OBJECTIVE
Evaluate walking speed and functional mobility with and without a 1.5 cm shoe lift under the non-affected lower limb in post-stroke gait.
METHODS
Forty-two subjects with hemiparesis after stroke were evaluated on a single day, under two conditions: with and without a 1.5 cm shoe lift. The assessment sequence was randomized and clinical tests (Ten-meter walk Test - 10MWT and Timed Up and Go - TUG) were performed one after the other.
RESULTS
There was a significant increase in walking speed in the 10MWT and shorter TUG times, with mean differences of 0.78 (CI95% 0.15-1.41, P ≤ 0.001, EF = 0.55) and 0.57 seconds (-0.11-1.25, P = .022, EF = 0.35), respectively.
CONCLUSION
The results showed that the immediate use of 1.5 cm shoe lifts seems to improve gait speed and functional mobility in chronic stroke patients. Further studies should focus on understanding the kinematics strategies and gait pattern alterations caused by shoe lifts under the NLL of post-stroke individuals.",2020,"There was a significant increase in walking speed in the 10MWT and shorter TUG times, with mean differences of 0.78 (CI95% 0.15-1.41, P ≤ 0.001, EF = 0.55) and 0.57 seconds (-0.11-1.25, P = .022, EF = 0.35), respectively.
","['Forty-two subjects with hemiparesis after stroke', 'chronic stroke patients']",[],"['quality of life', 'walking speed in the 10MWT and shorter TUG times', 'walking speed and functional mobility', 'gait speed and functional mobility']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",42.0,0.0230422,"There was a significant increase in walking speed in the 10MWT and shorter TUG times, with mean differences of 0.78 (CI95% 0.15-1.41, P ≤ 0.001, EF = 0.55) and 0.57 seconds (-0.11-1.25, P = .022, EF = 0.35), respectively.
","[{'ForeName': 'Caroline Echavarria', 'Initials': 'CE', 'LastName': 'Fortes', 'Affiliation': 'Department of Physical Therapy and Graduate Program in Rehabilitation Sciences, Faculty of Ceilândia, University of Brasília , Brasília, Brazil.'}, {'ForeName': 'Aline Araujo Do', 'Initials': 'AAD', 'LastName': 'Carmo', 'Affiliation': 'Department of Physical Therapy and Graduate Program in Rehabilitation Sciences, Faculty of Ceilândia, University of Brasília , Brasília, Brazil.'}, {'ForeName': 'Karissa Yasmim Araújo', 'Initials': 'KYA', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Therapy and Graduate Program in Rehabilitation Sciences, Faculty of Ceilândia, University of Brasília , Brasília, Brazil.'}, {'ForeName': 'Jerusa Petróvna Resende', 'Initials': 'JPR', 'LastName': 'Lara', 'Affiliation': 'Department of Physical Education, Federal University of Paraná , Curitiba, Brazil.'}, {'ForeName': 'Felipe Augusto Dos Santos', 'Initials': 'FADS', 'LastName': 'Mendes', 'Affiliation': 'Department of Physical Therapy and Graduate Program in Rehabilitation Sciences, Faculty of Ceilândia, University of Brasília , Brasília, Brazil.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1771798']
3193,32478917,Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis.,"BACKGROUND
Palliative care remains suboptimal in end-stage liver disease.
AIMS
To inform a definitive study, we assessed palliative long-term abdominal drains in end-stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison.
METHODS
A 12-week feasibility nonblinded randomised controlled trial comparing large-volume paracentesis vs long-term abdominal drains in refractory ascites due to end-stage liver disease with fortnightly home visits for clinical/questionnaire-based assessments. Study success criteria were attrition not >50%, <10% long-term abdominal drain removal due to complications, the long-term abdominal drain group to spend <50% ascites-related study time in hospital vs large-volume paracentesis group and 80% questionnaire/interview uptake/completion.
RESULTS
Of 59 eligible patients, 36 (61%) were randomised, 17 to long-term abdominal drain and 19 to large-volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long-term abdominal drain group vs large-volume paracentesis group) were 0 (0-1) vs 4 (3-7); week 12 serum albumin (g/L) and serum creatinine (μmol/L) were 29 (26.5-32.5) vs 30 (25-35) and 104.5 (81-115.5) vs 127 (63-158) respectively. Total attrition was 42% (long-term abdominal drain group 47%, large-volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital were lower in the long-term abdominal drain group, £329 (253-580) vs £843 (603-1060) and 0% (0-0.74) vs 2.75% (2.35-3.84) respectively. Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long-term abdominal drains could transform the care pathway.
CONCLUSIONS
The REDUCe study demonstrates feasibility with preliminary evidence of long-term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation.
TRIAL REGISTRATION
ISRCTN30697116, date assigned: 07/10/2015.",2020,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"['59 eligible patients, 36 (61']","['palliative long-term abdominal drains vs large-volume paracentesis', 'large-volume paracentesis vs long-term abdominal drains']","['Total attrition', 'peritonitis incidence', 'serum creatinine', 'Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital', 'Self-limiting cellulitis/leakage', 'median number (IQR) of hospital ascitic drains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441140', 'cui_str': 'Abdominal drain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040227', 'cui_str': 'Time Studies'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439685', 'cui_str': 'Ascitic'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]",59.0,0.162379,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Macken', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crook', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mason', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Lambert', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Evans', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Timeyin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Steer', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Austin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parnell', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Thomson', 'Affiliation': 'Worthing, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sheridan', 'Affiliation': 'Plymouth, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Isaacs', 'Affiliation': 'Blackpool, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hashim', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Brighton, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15802']
3194,32478922,"The effects of garlic (Allium sativum) supplementation on inflammatory biomarkers, fatigue, and clinical symptoms in patients with active rheumatoid arthritis: A randomized, double-blind, placebo-controlled trial.","Based on the antiinflammatory properties of garlic, current study was conducted to evaluate the garlic supplement effects on serum levels of some inflammatory biomarkers, clinical symptoms, and fatigue in women with active rheumatoid arthritis. In this randomized, double-blind, placebo-controlled trial study, 70 women with RA were randomly divided into two groups: The intervention group was supplemented with 1,000 mg of garlic, and the control group received placebo for 8 weeks. At baseline and at the end of the study, clinical symptoms, fatigue, serum level of C-reactive protein (CRP), tumor necrosis factor-a (TNF-a), and erythrocyte sedimentation rate (ESR) were determined. After intervention, serum levels of CRP (p = .018) and TNF-a (p < .001) decreased significantly in the garlic group as compared with the placebo group. Also, pain intensity, tender joint count, disease activity score (DAS-28), and fatigue were significantly decreased in the intervention group compared with the control group (p < .001; for all). Swollen joint count was significantly decreased in the garlic group (p < .001), but not in the placebo group (p = .123). No significant changes were observed for ESR. Garlic supplementation by improving inflammatory mediators and clinical symptoms can be considered as a potential adjunct treatment in patients with RA. However, further studies with larger duration are needed.",2020,"After intervention, serum levels of CRP (p = .018) and TNF-a (p < .001) decreased significantly in the garlic group as compared with the placebo group.","['patients with active rheumatoid arthritis', 'women with active rheumatoid arthritis', 'patients with RA', '70 women with RA']","['garlic (Allium sativum) supplementation', 'Garlic supplementation', 'intervention group was supplemented with 1,000\u2009mg of garlic, and the control group received placebo', 'placebo']","['inflammatory biomarkers, fatigue, and clinical symptoms', 'serum levels of some inflammatory biomarkers, clinical symptoms, and fatigue', 'Swollen joint count', 'ESR', 'serum levels of CRP', 'pain intensity, tender joint count, disease activity score (DAS-28), and fatigue', 'clinical symptoms, fatigue, serum level of C-reactive protein (CRP), tumor necrosis factor-a (TNF-a), and erythrocyte sedimentation rate (ESR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0993630', 'cui_str': 'Garlic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",70.0,0.447113,"After intervention, serum levels of CRP (p = .018) and TNF-a (p < .001) decreased significantly in the garlic group as compared with the placebo group.","[{'ForeName': 'Seyedeh Parisa', 'Initials': 'SP', 'LastName': 'Moosavian', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zamzam', 'Initials': 'Z', 'LastName': 'Paknahad', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Habibagahi', 'Affiliation': 'Department of Rheumatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Maracy', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6723']
3195,32473640,"Omega-3 fatty acid exposure with a low-fat diet in patients with past hypertriglyceridemia-induced acute pancreatitis; an exploratory, randomized, open-label crossover study.","BACKGROUND
Omega-3 fatty acids (OM3-FAs) are recommended with a low-fat diet for severe hypertriglyceridemia (SHTG), to reduce triglycerides and acute pancreatitis (AP) risk. A low-fat diet may reduce pancreatic lipase secretion, which is required to absorb OM3-ethyl esters (OM3-EEs), but not OM3-carboxylic acids (OM3-CAs).
METHODS
In this exploratory, randomized, open-label, crossover study, 15 patients with SHTG and previous AP were instructed to take OM3-CA (2 g or 4 g) and OM3-EE 4 g once daily for 4 weeks, while adhering to a low-fat diet. On day 28 of each treatment phase, a single dose was administered in the clinic with a liquid low-fat meal, to assess 24-h plasma exposure. Geometric least-squares mean ratios were used for between-treatment comparisons of baseline (day 0)-adjusted area under the plasma concentration versus time curves (AUC 0-24 ) and maximum plasma concentrations (C max ) for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
RESULTS
Before initiating OM3-FA treatment, mean baseline fasting plasma EPA + DHA concentrations (nmol/mL) were 723 for OM3-CA 2 g, 465 for OM3-CA 4 g and 522 for OM3-EE 4 g. At week 4, mean pre-dose fasting plasma EPA + DHA concentrations increased by similar amounts (+ 735 - + 768 nmol/mL) for each treatment. During the 24-h exposure assessment (day 28), mean plasma EPA + DHA increased from pre-dose to the maximum achieved concentration by + 32.7%, + 45.8% and + 3.1% with single doses of OM3-CA 2 g, OM3-CA 4 g and OM3-EE 4 g, respectively. Baseline-adjusted AUC 0-24 was 60% higher for OM3-CA 4 g than for OM3-EE 4 g and baseline-adjusted C max was 94% higher (both non-significant).
CONCLUSIONS
Greater 24-h exposure of OM3-CA versus OM3-EE was observed for some parameters when administered with a low-fat meal at the clinic on day 28. However, increases in pre-dose fasting plasma EPA + DHA over the preceding 4-week dosing period were similar between treatments, leading overall to non-significant differences in baseline (day 0)-adjusted AUC 0-24 and C max EPA + DHA values. It is not clear why the greater 24-h exposure of OM3-CA versus OM3-EE observed with a low-fat meal did not translate into significantly higher pre-dose fasting levels of DHA + EPA with longer-term use.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02189252, Registered 23 June 2014.",2020,"Baseline-adjusted AUC 0-24 was 60% higher for OM3-CA 4 g than for OM3-EE 4 g and baseline-adjusted C max was 94% higher (both non-significant).
","['15 patients with SHTG and previous AP', 'patients with past hypertriglyceridemia-induced acute pancreatitis']","['Omega-3 fatty acid exposure with a low-fat diet', 'Omega-3 fatty acids (OM3-FAs', 'OM3-EE 4\u2009g once daily for 4\u2009weeks, while adhering to a low-fat diet', 'OM3-CA', 'OM3-CA versus OM3-EE']","['DHA concentrations', 'mean plasma EPA\u2009+\u2009DHA', 'maximum plasma concentrations (C max ) for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'pre-dose fasting plasma EPA\u2009+\u2009DHA', 'mean baseline fasting plasma EPA\u2009+\u2009DHA concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",15.0,0.0470296,"Baseline-adjusted AUC 0-24 was 60% higher for OM3-CA 4 g than for OM3-EE 4 g and baseline-adjusted C max was 94% higher (both non-significant).
","[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Dunbar', 'Affiliation': 'Cardiometabolic and Lipid Clinic, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA. r.l.dunbar@gmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Lipidology Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Saguenay, QC, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'University of Chicago Pritzker School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rensfeldt', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Nilsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Kvarnström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}]",Lipids in health and disease,['10.1186/s12944-020-01295-7']
3196,32473644,Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial.,"BACKGROUND
Coronary artery diseases (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in progressive replacement of contractile myocardium with dysfunctional, fibrotic scar tissue. Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure. Available neurohumoral treatment strategies aim at the improvement of symptoms. Despite extensive research, therapeutic options for myocardial regeneration, including (stem)-cell therapy, gene therapy, cellular reprogramming or tissue engineering, remain purely experimental. Thus, there is an urgent clinical need for novel treatment options for inducing myocardial regeneration and improving left-ventricular function in ischemic cardiomyopathy. Shockwave Therapy (SWT) is a well-established regenerative tool that is effective for the treatment of chronic tendonitis, long-bone non-union and wound-healing disorders. In preclinical trials, SWT regenerated ischemic myocardium via the induction of angiogenesis and the reduction of fibrotic scar tissue, resulting in improved left-ventricular function.
METHODS/DESIGN
In this prospective, randomized controlled, single-blind, monocentric study, 80 patients with reduced left-ventricular ejection fraction (LVEF≤ 40%) are subjected to coronary-artery bypass-graft surgery (CABG) surgery and randomized in a 1:1 ratio to receive additional cardiac SWT (intervention group; 40 patients) or CABG surgery with sham treatment (control group; 40 patients). This study aims to evaluate (1) the safety and (2) the efficacy of cardiac SWT as adjunctive treatment during CABG surgery for the regeneration of ischemic myocardium. The primary endpoints of the study represent (1) major cardiac events and (2) changes in left-ventricular function 12 months after treatment. Secondary endpoints include 6-min Walk Test distance, improvement of symptoms and assessment of quality of life.
DISCUSSION
This study aims to investigate the safety and efficacy of cardiac SWT during CABG surgery for myocardial regeneration. The induction of angiogenesis, decrease of fibrotic scar tissue formation and, thus, improvement of left-ventricular function could lead to improved quality of life and prognosis for patients with ischemic heart failure. Thus, it could become the first clinically available treatment strategy for the regeneration of ischemic myocardium alleviating the socio-economic burden of heart failure.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT03859466. Registered on 1 March 2019.",2020,Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure.,"['80 patients with reduced left-ventricular ejection fraction (LVEF≤\u200940', 'patients with ischemic heart failure', 'patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial']","['Shockwave Therapy (SWT', 'coronary-artery bypass-graft surgery (CABG) surgery', 'cardiac SWT', 'direct Cardiac Shockwave Therapy', 'additional cardiac SWT (intervention group; 40 patients) or CABG surgery with sham treatment']","['fibrotic scar tissue formation', 'study represent (1) major cardiac events and (2) changes in left-ventricular function', '6-min Walk Test distance, improvement of symptoms and assessment of quality of life', 'quality of life and prognosis', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0241158', 'cui_str': 'Scar of skin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",80.0,0.112858,Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure.,"[{'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Pölzl', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Nägele', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Graber', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Hirsch', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Lobenwein', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mitrovic', 'Affiliation': 'Clinical Trial Center, Medical University of Innsbruck, Innrain 52, 6020, Innsbruck, Austria.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Mayr', 'Affiliation': 'University Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Theurl', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schreinlechner', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Pamminger', 'Affiliation': 'University Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dorfmüller', 'Affiliation': 'Heart Regeneration Technologies GmbH, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grimm', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Gollmann-Tepeköylü', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Holfeld', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. Johannes.holfeld@i-med.ac.at.'}]",Trials,['10.1186/s13063-020-04369-0']
3197,32473649,"The propofol-sparing effect of intravenous lidocaine in elderly patients undergoing colonoscopy: a randomized, double-blinded, controlled study.","BACKGROUND
Propofol provides a prominent sedation effect in colonoscopy. However, anesthesia and sedation induced with propofol in the elderly might result in cardiopulmonary complications, especially when it is combined with opoids in the regimen. This study aimed to test the hypothesis that the addition of intravenous lidocaine to propofol-based sedation could decrease the overall propofol requirement in elderly patients during colonoscopy while the procedural sedation satisfaction and the hemodynamic stability were not compromised.
METHODS
Ninety-two patients undergoing colonoscopy were randomly enrolled into lidocaine+propofol (L + P) group or normal saline+propofol (NS + P) groups. Subjects received intravenous bolus of 1.5 mg/kg lidocaine followed by 4 mg kg - 1 h - 1 lidocaine continuous infusion in L + P group or equivalent volumes of normal saline for boluses and infusion in NS + P group. Anesthesia was induced with 2.5 μg sufentanil followed by injection of 1.2 mg kg - 1 propofol in all patients. A single supplemental bolus of 0.6 mg kg - 1 propofol was administered whenever MOAA/S score > 1 or had body movement during the colonoscopy. The recorded primary endpoints included: the total amount of propofol administered during entire procedure, the supplemental amount of propofol after induction, and the frequencies of boluses of supplemental propofol.
RESULTS
A total of 79 patients were included in the final analysis. Compared with NS + P group, the total amounts of propofol (induction plus supplemental) were no significant differences in L + P group; however, the required supplemental propofol was less (69.9 ± 39.2 mg vs. 51.5 ± 38.6 mg) (P = 0.039); the average frequencies of boluses of supplemental propofol given after induction were lower (2.1 ± 1.1 vs. 1.4 ± 0.9) (P = 0.003); the calculated ""unit propofol"" infusion rate was lower (0.18 ± 0.05 vs. 0.14 ± 0.04 mg kg - 1 min - 1 ) (P = 0.002).
CONCLUSIONS
The addition of intravenous lidocaine to propofol-based sedation resulted in a remarked reduction of supplemental propofol in the elderly during colonoscopy.
TRIAL REGISTRATION
The present clinical trial was registered at http://www.chictr.org.cn on 11th March 2019 (registration No. ChiCTR1900021818).",2020,"Compared with NS + P group, the total amounts of propofol (induction plus supplemental) were no significant differences in L + P group; however, the required supplemental propofol was less (69.9 ± 39.2 mg vs. 51.5 ± 38.6 mg) (P = 0.039); the average frequencies of boluses of supplemental propofol given after induction were lower (2.1 ± 1.1 vs. 1.4 ± 0.9) (P = 0.003); the calculated ""unit propofol"" infusion rate was lower (0.18 ± 0.05 vs. 0.14 ± 0.04 mg kg - 1 min - 1 ) (P = 0.002).
","['elderly patients during colonoscopy', 'A total of 79 patients were included in the final analysis', 'Ninety-two patients undergoing colonoscopy', 'elderly patients undergoing colonoscopy']","['lidocaine+propofol (L\u2009+\u2009P) group or normal saline+propofol (NS\u2009+\u2009P', 'lidocaine', 'intravenous lidocaine', 'propofol-based sedation', 'intravenous bolus of 1.5\u2009mg/kg lidocaine', 'lidocaine continuous infusion in L\u2009+\u2009P group or equivalent volumes of normal saline for boluses and infusion in NS\u2009+\u2009P group', 'Propofol', 'propofol']","['calculated ""unit propofol"" infusion rate', 'overall propofol requirement', 'total amount of propofol administered during entire procedure, the supplemental amount of propofol after induction, and the frequencies of boluses of supplemental propofol', 'total amounts of propofol']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",79.0,0.134813,"Compared with NS + P group, the total amounts of propofol (induction plus supplemental) were no significant differences in L + P group; however, the required supplemental propofol was less (69.9 ± 39.2 mg vs. 51.5 ± 38.6 mg) (P = 0.039); the average frequencies of boluses of supplemental propofol given after induction were lower (2.1 ± 1.1 vs. 1.4 ± 0.9) (P = 0.003); the calculated ""unit propofol"" infusion rate was lower (0.18 ± 0.05 vs. 0.14 ± 0.04 mg kg - 1 min - 1 ) (P = 0.002).
","[{'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Junzheng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesia and Pediatrics, Cincinnati Children Hospital Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Wangning', 'Initials': 'W', 'LastName': 'Shangguan', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China. sgwning@163.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01049-z']
3198,32473654,Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol.,"BACKGROUND
The effects of endometrial scratching (ES) on embryo implantation have been studied for many years. Several studies have shown better outcomes when performed on patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles, but many other reports have not been able to find these differences. As far as cycles with donor eggs are concerned, reported evidence is scarce. Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation.
METHODS
This single centre randomized controlled trial will include patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study. Once informed consent is signed, patients will be randomly allocated to the study arm (group A) and then receive ES in the luteal phase of the cycle prior to embryo transfer, or the control arm (group B) without any intervention. All cycle data will be collected and analyzed to obtain the clinical pregnancy and the live birth rates in the two groups.
DISCUSSION
Several studies have tried to determine the effectiveness of an ES in IVF cycles, but it is still unclear due to the heterogeneity of these reports. The aim of this study is to determine if there are differences in clinical pregnancy rate and live birth rate in egg donor cycles, when comparing an ES performed in the preceding luteal phase versus no intervention, given that embryo quality and endometrial preparation protocols will be comparable.
TRIAL REGISTRATION
Ethical approval of version 2.0 of this trial was obtained on the 13th January 2017. It was retrospectively registered on the 5th April 2017 as the ENDOSCRATCH Trial (NCT03108157) in ClinicalTrials.gov.",2020,"Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation.
","['patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles', 'patients undergoing IVF cycles with donor eggs', 'patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study']","['Endometrial scratch vs no intervention', 'endometrial scratching (ES']","['live birth rates', 'clinical pregnancy rate and live birth rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",,0.165196,"Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation.
","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Izquierdo', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain. izquierdo.alexandra@yahoo.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'de la Fuente', 'Affiliation': 'Human Reproduction Unit, Department of Obstetrics and Gynecology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Spies', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rayward', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'López', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lora', 'Affiliation': 'Clinical Research Unit (imas12-CIBERESP). University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Galindo', 'Affiliation': 'Fetal Medicine Unit - Maternal and Child Health and Development Network (Red SAMID-RD12/0026/0016). Department of Obstetrics and Gynecology. University Hospital 12 de Octubre. 12 de Octubre Research Institute (imas12), Complutense University of Madrid, Madrid, Spain.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-02958-0']
3199,32473765,Outcomes of orthodontic treatment performed by individual orthodontists vs 2 orthodontists collaborating on treatment.,"INTRODUCTION
One factor that can affect treatment outcomes is the treatment provider, and this factor has not been extensively studied. This research aimed to evaluate orthodontic treatment quality, length, and efficiency when 2 orthodontists collaborated on treatment, compared with the treatment provided solely by either orthodontist.
METHODS
A total of 150 consecutively treated subjects were divided into 3 equal groups based on the treating clinician. Patients in group A were treated by orthodontist A, group B by orthodontist B, and group C by both orthodontists in collaboration. The Peer Assessment Rating (PAR), Index of Complexity, Outcome, and Need (ICON), American Board of Orthodontics-Discrepancy Index, and American Board of Orthodontics-Cast and Radiographic Evaluation were used to assess the pretreatment and posttreatment status. Patient age, gender, type of malocclusion, extraction treatment, orthognathic surgery, treatment length, number of visits, and treatment efficiency index were assessed.
RESULTS
Posttreatment PAR and ICON indices showed excellent results in all 3 groups. American Board of Orthodontics-Cast and Radiographic Evaluation was significantly higher in group C (25.3 points) than in group A (21.5 points) or group B (22.0 points) (P = 0.014). Patients in group A had significantly shorter treatment time (23 months) than those in either group B or C (26 months) (P = 0.011). Patients in group C required more appointments (27 visits) than those in either group A or B (23 and 25 visits, respectively). The treatment efficiency index showed no statistically significant difference among the 3 groups.
CONCLUSIONS
There was no difference in treatment quality among the 3 groups, as assessed by the PAR index and ICON. Jointly treated cases required 2 to 4 more visits and had higher American Board of Orthodontics-Cast and Radiograph Evaluation scores than those treated by either orthodontist. Complex cases required 6 to 7 more months when they were treated collaboratively.",2020,Jointly treated cases required 2 to 4 more visits and had higher American Board of Orthodontics-Cast and Radiograph Evaluation scores than those treated by either orthodontist.,['A total of 150 consecutively treated subjects'],[],"['shorter treatment time', 'Peer Assessment Rating (PAR), Index of Complexity, Outcome, and Need (ICON), American Board of Orthodontics-Discrepancy Index, and American Board of Orthodontics-Cast and Radiographic Evaluation', 'PAR index and ICON', 'treatment quality', 'higher American Board of Orthodontics-Cast and Radiograph Evaluation scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429164', 'cui_str': 'Peer assessment rating (orthodontic index)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",150.0,0.0151119,Jointly treated cases required 2 to 4 more visits and had higher American Board of Orthodontics-Cast and Radiograph Evaluation scores than those treated by either orthodontist.,"[{'ForeName': 'Suliman A', 'Initials': 'SA', 'LastName': 'Alsaeed', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada; College of Dentistry, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: alsaeeds@mail.ubc.ca.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Kennedy', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada; Private Practice, Vancouver and Richmond, British Columbia, Canada.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Aleksejuniene', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Yen', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Pliska', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Donal C', 'Initials': 'DC', 'LastName': 'Flanagan', 'Affiliation': 'Private Practice, Vancouver and Delta, British Columbia, Canada.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.015']
3200,32473797,Prior Application of 10% Potassium Nitrate to Reduce Postbleaching Sensitivity: A Randomized Triple-Blind Clinical Trial.,"OBJECTIVE
To evaluate if the topical application of 10% potassium nitrate applied before in-office bleaching is effective to reduce the risk and intensity of tooth sensitivity (TS), as well as to evaluate if its application can jeopardize color change.
MATERIALS AND METHODS
A randomized, split-mouth triple-blind clinical trial was conducted on 43 young patients with incisors A2 or darker. Half of the patient's upper arch received either the application of a 10% potassium nitrate or placebo gel for 10 min in a university setting. In-office bleaching was performed in three 15-min applications in two clinical sessions (1-week interval) using 35% hydrogen peroxide. Risk and intensity of TS was recorded with a 0-4 Numeric Rating Scale and a 0-10 Visual Analogue Scale during bleaching, 1 hour, 24 hours, and 48 hours after bleaching. Color was evaluated before and 1 month after bleaching with shade guides (Vita Classical and Vita Bleachedguide) and a spectrophotometer. The risk of TS (McNemar's test) and intensity of TS (Wilcoxon signed-rank for Numeric Rating Scale and paired t-test for Visual Analogue Scale) were statistically evaluated. Color change was compared using paired t-test. Significant level was set at 5%.
RESULTS
No significant difference was observed in the absolute risks of TS between groups (RR = 1.11; 95% CI 0.97 to 1.27; P = .12), which exceeded 87% for both groups. Similarly, no difference in TS intensities was detected (P > .05). Significant whitening was observed with all color measurement instruments with no difference between groups (P > .05).
CONCLUSION
The topical application of 10% potassium nitrate, before in-office bleaching, did not reduce the risk and intensity of TS and did not jeopardize color change.",2020,"Significant whitening was observed with all color measurement instruments with no difference between groups (P > .05).
",['43 young patients with incisors A2 or darker'],"['hydrogen peroxide', 'potassium nitrate or placebo gel', 'Potassium Nitrate', '10% potassium nitrate']","[""risk of TS (McNemar's test) and intensity of TS (Wilcoxon signed-rank for Numeric Rating Scale and paired t-test for Visual Analogue Scale"", 'risk and intensity of tooth sensitivity (TS', 'absolute risks of TS', 'risk and intensity of TS', 'Postbleaching Sensitivity', 'Risk and intensity of TS', 'TS intensities']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",43.0,0.123407,"Significant whitening was observed with all color measurement instruments with no difference between groups (P > .05).
","[{'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Rezende', 'Affiliation': 'School of Dentistry, Paulo Picanço School of Dentistry, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Karine Leticia', 'Initials': 'KL', 'LastName': 'da Silva', 'Affiliation': 'State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Thais Caroline', 'Initials': 'TC', 'LastName': 'Miguel', 'Affiliation': 'State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Paulo Vitor', 'Initials': 'PV', 'LastName': 'Farago', 'Affiliation': 'School of Pharmacy, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Alessandro Dourado', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Luciana Dorochenko', 'Initials': 'LD', 'LastName': 'Martins', 'Affiliation': 'State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil. Electronic address: reis_ale@hotmail.com.'}]",The journal of evidence-based dental practice,['10.1016/j.jebdp.2020.101406']
3201,32473974,"Bimekizumab for patients with moderate-to-severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled phase 2b extension study.","BACKGROUND
Dual neutralization of both interleukin-17A and interleukin-17F with the monoclonal antibody bimekizumab may have greater efficacy in psoriasis than neutralization of interleukin-17A alone.
OBJECTIVE
To provide longer-term efficacy and safety data for bimekizumab from a phase 2b extension study in patients with moderate-to-severe psoriasis (BE ABLE 2, NCT03010527).
METHODS
After the 12-week initial study (BE ABLE 1), patients who had a Psoriasis Area and Severity Index (PASI) 90 response at week 12 received bimekizumab 64 mg, 160 mg, or 320 mg for an additional 48 weeks (60 weeks in total). The primary objective was safety.
RESULTS
Across all dose groups (N = 217), initial PASI90 responders generally maintained high levels of efficacy through week 60: PASI90, 80-100%; PASI100, 69-83%; Investigator's Global Assessment 0/1, 78-100% (all non-responder imputation). Incidence of serious treatment-emergent adverse events was 15/217 (6.9%). No cases of inflammatory bowel disease, MACE, or suicidal ideation/behavior were reported.
LIMITATIONS
Low numbers in the bimekizumab 64 mg group (n = 15). The majority of 60-week data reported here are primarily for the week 12 PASI90 responders only.
CONCLUSION
Bimekizumab response rates were maintained through week 60. A substantial proportion of patients achieved complete skin clearance. Bimekizumab was generally well tolerated.",2020,"Across all dose groups (N = 217), initial PASI90 responders generally maintained high levels of efficacy through week 60: PASI90, 80-100%; PASI100, 69-83%; Investigator's Global Assessment 0/1, 78-100% (all non-responder imputation).","['patients with moderate-to-severe plaque psoriasis', 'patients who had a Psoriasis Area and Severity Index (PASI) 90 response at week 12 received', 'patients with moderate-to-severe psoriasis (BE ABLE 2, NCT03010527']","['Bimekizumab', 'bimekizumab', 'PASI90', 'placebo']","['tolerated', 'complete skin clearance', 'safety', 'Bimekizumab response rates', 'Incidence of serious treatment-emergent adverse events', 'inflammatory bowel disease, MACE, or suicidal ideation/behavior']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]","[{'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.165099,"Across all dose groups (N = 217), initial PASI90 responders generally maintained high levels of efficacy through week 60: PASI90, 80-100%; PASI100, 69-83%; Investigator's Global Assessment 0/1, 78-100% (all non-responder imputation).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA. Electronic address: ablauvelt@oregonmedicalresearch.com.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research and K Papp Clinical Research, Waterloo, and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cross', 'Affiliation': 'UCB Biosciences Inc., Raleigh, NC, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Madden', 'Affiliation': 'UCB Biosciences Inc., Raleigh, NC, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'UCB Biosciences Inc., Raleigh, NC, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cioffi', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Salford Royal Hospital, University of Manchester, Manchester NIHR Biomedical Research Centre, Manchester, UK.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.05.105']
3202,32474062,The effects on ovarian activity of delaying versus immediately restarting combined oral contraception after missing three pills and taking ulipristal acetate 30 mg.,"OBJECTIVE
Among combined oral contraception (COC) users who missed three consecutive tablets, to determine the effect on ovarian activity and ovulation of waiting five days before restarting COC, versus restarting immediately, having taken ulipristal acetate 30 mg (UPA, the dose used for emergency contraception) after missing three COC pills.
STUDY DESIGN
Women already using COC were enrolled for two cycles of COC use (21/7 regimen). In cycle 2, all women omitted COC pills for three consecutive days (days 5,6,7), and on day 8 took UPA 30 mg. They were randomized either to restart their COC pills that same day (immediate restart) or to wait five days (delayed restart). Transvaginal ultrasound, and blood sampling for estradiol and progesterone were undertaken on days 4,8,11,13,15,18,22 and 26. A modified Hoogland score was used to quantify ovarian activity/ovulation and to assess whether luteal phase progesterone concentrations were sufficiently 'adequate' to have conferred a theoretical risk of pregnancy.
RESULTS
No-one ovulated with risk of pregnancy during the five days following UPA. Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle. Four of 23 women (17.4% CI [5.0; 38.8]) with delayed restart ovulated with theoretical risk of pregnancy before the end of the cycle. This difference was statistically significant (p=0.042).
CONCLUSION
Women who delay restarting COC for five after taking UPA 30 mg are at much greater risk of ovulation, and therefore theoretically of pregnancy, than if they restart their COC on the same day as taking UPA. Current recommendations should be revisited.",2020,"Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle.","['Women who delay restarting COC for five after taking', 'Women already using COC were enrolled for two cycles of COC use (21/7 regimen', '26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle']","['UPA', 'combined oral contraception (COC']","['ovarian activity', 'Transvaginal ultrasound, and blood sampling for estradiol and progesterone', 'risk of ovulation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4546343', 'cui_str': 'Uses contraception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0404588', 'cui_str': 'Finding related to risk factor in pregnancy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]",26.0,0.105905,"Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle.","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Banh', 'Affiliation': 'HRA Pharma, 200 avenue de Paris, 92320 Châtillon, France. Electronic address: c.banh@HRA-PHARMA.COM.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Rautenberg', 'Affiliation': 'Dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Duijkers', 'Affiliation': 'Dinox Consultancy, Marktstraat 19, 9712 PB Groningen, the Netherlands.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Borenzstein', 'Affiliation': 'HRA Pharma, 200 avenue de Paris, 92320 Châtillon, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Monteil', 'Affiliation': 'HRA Pharma, 200 avenue de Paris, 92320 Châtillon, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Levy-Gompel', 'Affiliation': 'HRA Pharma, 200 avenue de Paris, 92320 Châtillon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Klipping', 'Affiliation': 'Dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scherrer', 'Affiliation': 'Bruno Scherrer Conseil, 78730 Saint-Arnoult-en-Yvelines, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Glasier', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Midlothian EH16 4TJ, UK.""}]",Contraception,['10.1016/j.contraception.2020.05.013']
3203,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE
By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population.
METHODS
This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH.
CONCLUSION
This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047']
3204,32474156,Dupilumab improves clinical outcomes in patients with asthma and perennial allergic rhinitis.,"BACKGROUND
Comorbid perennial allergic rhinitis (PAR), or year-round aeroallergen sensitivity, significantly contributes to disease burden in asthma patients. Dupilumab blocks the shared receptor for interleukin (IL)-4 and IL-13, key drivers of type 2 inflammation that play important roles in asthma and PAR. In LIBERTY ASTHMA QUEST (NCT02414854), dupilumab reduced severe asthma exacerbations and improved forced expiratory volume in 1 second (FEV1) in patients with uncontrolled, moderate-to-severe asthma, with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers at baseline (blood eosinophils and fractional exhaled nitric oxide [FeNO]).
OBJECTIVE
We assessed dupilumab efficacy in QUEST patients with comorbid PAR (allergic rhinitis history and ≥1 perennial aeroallergen-specific IgE ≥0.35 kU/L at baseline).
METHODS
Severe asthma exacerbation rates, FEV1, asthma control (ACQ-5), rhinoconjunctivitis-specific health-related quality of life (HRQoL) (RQLQ[S]+12), and type 2 inflammatory biomarkers during the 52-week treatment period were assessed.
RESULTS
814/1902 (42.8%) patients had comorbid PAR. Dupilumab 200 and 300 mg q2w versus placebo reduced severe exacerbations rates by 32.2% and 34.6% (both P<.05), and improved FEV1 at Week 12 by 0.14 L and 0.18 L (both P<.01); greater efficacy was observed in patients with elevated baseline blood eosinophils (≥300 cells/μL) and FeNO. Dupilumab treatment also numerically improved ACQ-5 and RQLQ(s)+12 scores, and suppressed type 2 inflammatory biomarkers.
CONCLUSION
Dupilumab improved key asthma-related outcomes, asthma control and rhinoconjunctivitis-specific HRQoL, while suppressing type 2 inflammatory biomarkers and perennial allergen specific IgE in patients with moderate-to-severe asthma and comorbid PAR, highlighting its dual inhibitory effects on IL-4/IL-13 and its role in managing both asthma and PAR.",2020,"Dupilumab 200 and 300 mg q2w versus placebo reduced severe exacerbations rates by 32.2% and 34.6% (both P<.05), and improved FEV1 at Week 12 by 0.14 L and 0.18 L (both P<.01); greater efficacy was observed in patients with elevated baseline blood eosinophils (≥300 cells/μL) and FeNO.","['asthma patients', 'patients with asthma and perennial allergic rhinitis', 'patients with moderate-to-severe asthma and comorbid PAR', 'patients had comorbid PAR', 'QUEST patients with comorbid PAR (allergic rhinitis history and ≥1 perennial aeroallergen-specific IgE ≥0.35 kU/L at baseline']","['Dupilumab', 'placebo']","['Severe asthma exacerbation rates, FEV1, asthma control (ACQ-5), rhinoconjunctivitis-specific health-related quality of life (HRQoL) (RQLQ[S]+12), and type 2 inflammatory biomarkers', 'forced expiratory volume', 'ACQ-5 and RQLQ(s)+12 scores, and suppressed type 2 inflammatory biomarkers', 'severe exacerbations rates', 'FEV1', 'dupilumab efficacy', 'efficacy']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0837837,"Dupilumab 200 and 300 mg q2w versus placebo reduced severe exacerbations rates by 32.2% and 34.6% (both P<.05), and improved FEV1 at Week 12 by 0.14 L and 0.18 L (both P<.01); greater efficacy was observed in patients with elevated baseline blood eosinophils (≥300 cells/μL) and FeNO.","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Electronic address: wwb@medicine.wisc.edu.'}, {'ForeName': 'Jorge F', 'Initials': 'JF', 'LastName': 'Maspero', 'Affiliation': 'Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Bradley E', 'Initials': 'BE', 'LastName': 'Chipps', 'Affiliation': 'Capital Allergy and Respiratory Disease Center, Sacramento, CA, USA.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Katelaris', 'Affiliation': 'Campbelltown Hospital and Western Sydney University, Campbelltown, Australia.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'University of British Columbia, Vancouver, BC, CA.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Quirce', 'Affiliation': 'Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Ford', 'Affiliation': 'Asthma and Allergy Center, Bellevue, NE, USA.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Siddhesh', 'Initials': 'S', 'LastName': 'Kamat', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Asif H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Jagerschmidt', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Harel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.026']
3205,32483493,Effects of Low-dose Propofol or Ketamine on Coughing at Emergence from Anesthesia in Children Undergoing Tonsillectomy.,"Introduction Coughing is commonly observed during emergence from general anesthesia. In children, smooth emergence from anesthesia, especially after tonsillectomy, is crucial. In this study, we compared the effect of low-dose ketamine or propofol on emergence coughing in children undergoing tonsillectomy. Methods In this randomized clinical trial, 90 children undergoing tonsillectomy were randomly allocated into two groups: children in group A received 0.5-mg/kg propofol and children in group B received 0.5-mg/kg ketamine, at the end of anesthesia. The incidence and severity of cough, postoperative sedation, nausea, and vomiting, and pain score were recorded and compared. Results The incidence of no cough at emergence from anesthesia was 82.2% in the propofol group and 15.5% in the ketamine group (P = 0.00). Children in the ketamine group exhibited postoperative pain but were more sedated compared with those in the propofol group (P > 0.05). The incidence of postoperative nausea and vomiting was lower in the propofol group (P < 0.05). Conclusions At the end of general anesthesia with isoflurane in children undergoing tonsillectomy, 0.5-mg/kg propofol is more effective than 0.5-mg/kg ketamine in reducing cough response upon emergence from anesthesia, with a lower incidence of nausea and vomiting, as well as lower sedation in children.",2020,The incidence of postoperative nausea and vomiting was lower in the propofol group (P < 0.05).,"['Children Undergoing Tonsillectomy', 'children undergoing tonsillectomy', '90 children undergoing tonsillectomy', 'children undergoing tonsillectomy, 0.5-mg/kg']","['isoflurane', 'ketamine', 'Ketamine', '0.5-mg/kg propofol and children in group B received 0.5-mg/kg ketamine', 'Low-dose Propofol', 'propofol']","['cough response', 'postoperative nausea and vomiting', 'incidence and severity of cough, postoperative sedation, nausea, and vomiting, and pain score', 'Coughing at Emergence', 'postoperative pain', 'nausea and vomiting', 'incidence of no cough at emergence from anesthesia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0425502', 'cui_str': 'No cough'}, {'cui': 'C1301785', 'cui_str': 'Emergence from anesthesia'}]",90.0,0.0555144,The incidence of postoperative nausea and vomiting was lower in the propofol group (P < 0.05).,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Sahmeddini', 'Affiliation': 'Anesthesiology, Shiraz Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, IRN.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Panah', 'Affiliation': 'Anesthesiology, Shiraz Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, IRN.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ghanbari', 'Affiliation': 'Anesthesiology, Shiraz Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, IRN.'}]",Cureus,['10.7759/cureus.7842']
3206,32483541,Dentin moisture conditions strongly influence its interactions with bioactive root canal sealers.,"Objectives
It is known that bioactive materials interact with the dentin to undergo biomineralization. The exact role of moisture in this interaction is unknown. Here, we investigate the effects of dentin moisture conditions on the dislocation resistance of two bioactive root canal sealers (MTA Fillapex [Angelus Solucoes Odontologicas] and GuttaFlow BioSeal [Colténe/Whaledent AG]) at 3 weeks and 3 months after obturation.
Materials and Methods
Mandibular premolars ( n = 120) were prepared and randomly divided into 3 groups based on the dentin condition: group 1, dry dentin; group 2, moist dentin; group 3, wet dentin. Each group was divided into 2 subgroups for root canal filling: MTA Fillapex and GuttaFlow BioSeal. Dislocation resistance was evaluated by measuring the push-out bond strength at 3 weeks and 3 months. Failure modes were examined under a stereomicroscope. Data were statistically analyzed by Kruskal-Wallis test with a significance level of 5%.
Results
Moist dentin resulted in higher bond strength values for both materials at both time points. This was significantly higher than wet and dry dentin for both the sealers at the 3 months ( p < 0.05), while at 3 weeks it was significant only for GuttaFlow Bioseal. The different moisture conditions demonstrated similar trends in their effects on the dislocation resistance of the 2 root canal sealers.
Conclusions
The dentin moisture conditions had a significant impact on its interaction with the bioactive materials tested. Maintaining moist dentin, but not dry or wet dentin, may be advantageous before the filling root canals with bioactive sealers.",2020,"This was significantly higher than wet and dry dentin for both the sealers at the 3 months ( p < 0.05), while at 3 weeks it was significant only for GuttaFlow Bioseal.",['Materials and Methods\n\n\nMandibular premolars ( n = 120'],"['root canal filling: MTA Fillapex and GuttaFlow BioSeal', 'dentin condition: group 1, dry dentin; group 2, moist dentin; group 3, wet dentin']","['higher bond strength values', 'Dislocation resistance', 'dislocation resistance']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C3852787', 'cui_str': 'MTA-Fillapex'}, {'cui': 'C1872787', 'cui_str': 'GuttaFlow'}, {'cui': 'C0385318', 'cui_str': 'Bioseal'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",120.0,0.0134595,"This was significantly higher than wet and dry dentin for both the sealers at the 3 months ( p < 0.05), while at 3 weeks it was significant only for GuttaFlow Bioseal.","[{'ForeName': 'Esin', 'Initials': 'E', 'LastName': 'Ozlek', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, The University of Van Yuzuncu Yil, Van, Turkey.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Gündüz', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, The University of Van Yuzuncu Yil, Van, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Akkol', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, The University of Van Yuzuncu Yil, Van, Turkey.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Neelakantan', 'Affiliation': 'Discipline of Endodontology, Department of Restorative Dental Sciences, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR.'}]",Restorative dentistry & endodontics,['10.5395/rde.2020.45.e24']
3207,32483546,Lactobacillus rhamnosus GG Usage in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children with Gastroesophageal Reflux Disease Treated with Proton Pump Inhibitors: A Randomized Double-Blinded Placebo-Controlled Trial.,"Purpose
Proton-pump inhibitors (PPIs) are frequently used to treat gastroesophageal reflux disease (GERD) in children, but recent evidence suggests a potential association between PPI treatment and some types of infections. The aim of this study was to assess the effectiveness of Lactobacillus rhamnosus GG (LGG) for the prevention of gastrointestinal and respiratory tract infections in children with GERD treated with PPI (omeprazol).
Methods
Children younger than 5 years with GERD were assigned by a computer-generated list to receive LGG (10 9 colony-forming units) or placebo, twice daily, concomitantly with PPI treatment for 4-6 weeks; they were followed up for 12 weeks after therapy. The primary outcome measures were the percentage of children with a minimum of one episode of respiratory tract infection and the percentage of children with a minimum of one episode of gastrointestinal infection during the study.
Results
Of 61 randomized children, 59 patients (LGG n=30; placebo n=29, mean age 11.3 months) were analyzed. There was no significant difference found between the LGG and placebo groups, either for the proportion of children with at least one respiratory tract infection (22/30 vs. 25/29, respectively; relative risk [RR] 0.85, 95% confidence interval [CI] 0.66-1.10) or for the proportion of children with at least one gastrointestinal infection (9/30 vs. 9/29, respectively; RR 0.97, 95% CI 0.45-2.09).
Conclusion
LGG was not effective in the prevention of infectious complications in children with GERD receiving PPI. Caution is needed in interpreting these results, as the study was terminated early due to slow subject recruitment.",2020,"There was no significant difference found between the LGG and placebo groups, either for the proportion of children with at least one respiratory tract infection (22/30 vs. 25/29, respectively; relative risk [RR] 0.85, 95% confidence interval [CI] 0.66-1.10) or for the proportion of children with at least one gastrointestinal infection (9/30 vs. 9/29, respectively; RR 0.97, 95% CI 0.45-2.09).
","['children with GERD treated with PPI (omeprazol', 'Methods\n\n\nChildren younger than 5 years with GERD', 'Children with Gastroesophageal Reflux Disease Treated with', 'children with GERD receiving PPI', '61 randomized children, 59 patients (LGG n=30; placebo n=29, mean age 11.3 months) were analyzed']","['Proton Pump Inhibitors', 'Placebo', 'Lactobacillus rhamnosus GG Usage', 'LGG', 'Proton-pump inhibitors (PPIs', 'Lactobacillus rhamnosus GG (LGG', 'placebo']","['percentage of children with a minimum of one episode of respiratory tract infection and the percentage of children with a minimum of one episode of gastrointestinal infection', 'gastrointestinal infection', 'respiratory tract infection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0729555', 'cui_str': 'Infection of digestive system'}]",61.0,0.164049,"There was no significant difference found between the LGG and placebo groups, either for the proportion of children with at least one respiratory tract infection (22/30 vs. 25/29, respectively; relative risk [RR] 0.85, 95% confidence interval [CI] 0.66-1.10) or for the proportion of children with at least one gastrointestinal infection (9/30 vs. 9/29, respectively; RR 0.97, 95% CI 0.45-2.09).
","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Dziechciarz', 'Affiliation': 'Department of Pediatrics, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Krenke', 'Affiliation': 'Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Hania', 'Initials': 'H', 'LastName': 'Szajewska', 'Affiliation': 'Department of Pediatrics, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Horvath', 'Affiliation': 'Department of Pediatrics, Medical University of Warsaw, Warsaw, Poland.'}]","Pediatric gastroenterology, hepatology & nutrition",['10.5223/pghn.2020.23.3.251']
3208,32483622,Nonlinear Effects of Dopamine D1 Receptor Activation on Visuomotor Coordination Task Performance.,"Dopamine plays an important role in the modulation of neuroplasticity, which serves as the physiological basis of cognition. The physiological effects of dopamine depend on receptor subtypes, and the D1 receptor is critically involved in learning and memory formation. Evidence from both animal and human studies shows a dose-dependent impact of D1 activity on performance. However, the direct association between physiology and behavior in humans remains unclear. In this study, four groups of healthy participants were recruited, and each group received placebo or medication inducing a low, medium, or high amount of D1 activation via the combination of levodopa and a D2 antagonist. After medication, fMRI was conducted during a visuomotor learning task. The behavioral results revealed an inverted U-shaped effect of D1 activation on task performance, where medium-dose D1 activation led to superior learning effects, as compared to placebo as well as low- and high-dose groups. A respective dose-dependent D1 modulation was also observed for cortical activity revealed by fMRI. Further analysis demonstrated a positive correlation between task performance and cortical activation at the left primary motor cortex. Our results indicate a nonlinear curve of D1 modulation on motor learning in humans and the respective physiological correlates in corresponding brain areas.",2020,Further analysis demonstrated a positive correlation between task performance and cortical activation at the left primary motor cortex.,['four groups of healthy participants'],"['Dopamine D1 Receptor Activation', 'placebo or medication inducing a low, medium, or high amount of D1 activation via the combination of levodopa and a D2 antagonist', 'dopamine', 'placebo']","['cortical activity', 'Visuomotor Coordination Task Performance', 'task performance and cortical activation']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0058697', 'cui_str': 'Dopamine-D1 Receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.0399821,Further analysis demonstrated a positive correlation between task performance and cortical activation at the left primary motor cortex.,"[{'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 701, Taiwan.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund 44139, Germany.'}, {'ForeName': 'Lin-Cho', 'Initials': 'LC', 'LastName': 'Liu', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund 44139, Germany.'}, {'ForeName': 'Shyh-Yuh', 'Initials': 'SY', 'LastName': 'Wei', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 701, Taiwan.'}, {'ForeName': 'Huai-Hsuan', 'Initials': 'HH', 'LastName': 'Tseng', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 701, Taiwan.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund 44139, Germany.'}, {'ForeName': 'Min-Fang', 'Initials': 'MF', 'LastName': 'Kuo', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund 44139, Germany.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhaa116']
3209,32483851,Effects of home-based pelvic floor muscle training on decreasing symptoms of stress urinary incontinence and improving the quality of life of urban adult Omani women: A randomized controlled single-blind study.,"AIM
This study aims to determine the effectiveness of home-based pelvic floor muscle training (PFMT) on decreasing the severity of symptoms and improving the quality of life (QOL) among Omani women with stress urinary incontinence (SUI).
METHODS
A randomized controlled single-blind trial was conducted in three primary health care centers in Muscat. Eligible women who were diagnosed with SUI (from a concurrent phase-I study which was a cross-sectional study to determine the prevalence of urinary incontinence in Oman) were invited to take part. The consenting subjects were randomly allocated to either an intervention group (unsupervised PFMT) or a control group (lecture with no PFMT). Baseline and 12-week assessment of both groups was carried out for the primary outcome using the validated Arabic version of the International Consultation on Incontinence Questionnaire (ICIQ)-short form and the secondary outcome by blinded measures of pelvic floor muscle (PFM) strength using the modified Oxford grading system (MOGS), endurance, and perineometer.
RESULTS
A total of 73 subjects were included in the study. They were randomly divided into two groups. Both groups were similar at the baseline in terms of sociodemographic characteristics, ICIQ score, and PFM strength. At the 12-weeks assessment, there was a significant difference in the ICIQ score (P < .001) between the intervention group and the control one. There was no statistical difference between the two groups in MOGS, endurance, or perineometer values.
CONCLUSIONS
The home-based PFMT is an effective treatment in reducing the severity of symptoms and improving the QOL in women with SUI.",2020,"At the 12-weeks assessment, there was a significant difference in the ICIQ score (P < .001) between the intervention group and the control one.","['women with SUI', 'Omani women with stress urinary incontinence (SUI', 'three primary health care centers in Muscat', 'A total of 73 subjects were included in the study', 'urban adult Omani women', 'urinary incontinence in Oman', 'Eligible women who were diagnosed with SUI (from a concurrent phase']","['home-based pelvic floor muscle training', 'intervention group (unsupervised PFMT', 'home-based pelvic floor muscle training (PFMT', 'control group (lecture with no PFMT']","['quality of life', 'validated Arabic version of the International Consultation on Incontinence Questionnaire (ICIQ)-short form and the secondary outcome by blinded measures of pelvic floor muscle (PFM) strength using the modified Oxford grading system (MOGS), endurance, and perineometer', 'ICIQ score', 'MOGS, endurance, or perineometer values', 'quality of life (QOL', 'sociodemographic characteristics, ICIQ score, and PFM strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205871', 'cui_str': 'Muscat'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0028971', 'cui_str': 'Oman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0491718', 'cui_str': 'Perineometer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",73.0,0.0513096,"At the 12-weeks assessment, there was a significant difference in the ICIQ score (P < .001) between the intervention group and the control one.","[{'ForeName': 'Zalikha I', 'Initials': 'ZI', 'LastName': 'Al Belushi', 'Affiliation': 'Department of Primary Care, North Batinah Governorate, Ministry of Health, Suhar, Oman.'}, {'ForeName': 'Maisa H', 'Initials': 'MH', 'LastName': 'Al Kiyumi', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Ahlaam A', 'Initials': 'AA', 'LastName': 'Al-Mazrui', 'Affiliation': 'Physiotherapy Department, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Jaju', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Abdul H', 'Initials': 'AH', 'LastName': 'Alrawahi', 'Affiliation': 'Department of Research and Studies, Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Abdulaziz M', 'Initials': 'AM', 'LastName': 'Al Mahrezi', 'Affiliation': 'Department of Family Medicine and Public Health, Sultan Qaboos University Hospital, Muscat, Oman.'}]",Neurourology and urodynamics,['10.1002/nau.24404']
3210,32483861,"L-Dex, arm volume, and symptom trajectories 24 months after breast cancer surgery.","PURPOSE
Study objectives were to examine: (a) biomarker trajectories (change from presurgical baseline values of Lymphedema index (L-Dex) units and arm volume difference) and symptom cluster scores 24 months after breast cancer surgery and (b) associations of these objective biomarkers and symptom cluster scores. Patient/treatment characteristics influencing trajectories were also evaluated.
METHODS
A secondary analysis of data from the published interim analysis of a randomized parent study was undertaken using trajectory analysis. Five hundred and eight participants included in the prior analysis with 24 months of postsurgical follow-up were initially measured with bioelectric impedance spectroscopy (BIS) and tape measure (TM) and completed self-report measures. Patients were reassessed postsurgery for continuing eligibility and then randomized to either BIS or TM groups and measured along with self-report data at regular and optional* visits 3, 6,12,15*,18, 21*, and 24-months.
RESULTS
Three subclinical trajectories were identified for each biomarker (decreasing, stable, increasing) and symptom cluster scores (stable, slight increase/decrease, increasing). Subclinical lymphedema was identified throughout the 24-month period by each biomarker. An L-Dex increase at 15 months in the BIS group was noted. The self-report sets demonstrated contingency coefficients of 0.20 (LSIDS-A soft tissue, P = .031) and 0.19 (FACTB+4, P = .044) with the L-Dex unit change trajectories.
CONCLUSIONS
These data support the need for long-term (24 months) prospective surveillance with frequent assessments (every 3 months) at least 15 months after surgery. Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.",2020,Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.,['Five hundred and eight participants included in the prior analysis with 24\xa0months of postsurgical follow-up were initially measured with'],['BIS or TM'],"['bioelectric impedance spectroscopy (BIS) and tape measure (TM) and completed self-report measures', 'Subclinical lymphedema']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C2936361', 'cui_str': 'Impedance Spectroscopy'}, {'cui': 'C0336570', 'cui_str': 'Measuring tape'}]","[{'cui': 'C2936361', 'cui_str': 'Impedance Spectroscopy'}, {'cui': 'C0336570', 'cui_str': 'Measuring tape'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]",508.0,0.0250319,Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.,"[{'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'Vanderbilt University School of Nursing, Nashville, TN, USA.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boyages', 'Affiliation': 'Australian Lymphoedema Education, Research, and Treatment (ALERT) Program, Faculty of Medicine & Health Sciences, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Koelmeyer', 'Affiliation': 'ALERT Program, Faculty of Medicine & Health Sciences, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Ajkay', 'Affiliation': 'Breast Surgical Oncology, University of Louisville, Louisville, KY, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'DeSnyder', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'McLaughlin', 'Affiliation': 'Surgery, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'Vanderbilt University School of Nursing and Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Cancer medicine,['10.1002/cam4.3188']
3211,32483928,Comparison of heated humidified high flow nasal cannula and nasal continuous positive airway pressure after surfactant administration in preterm neonates with respiratory distress syndrome.,"BACKGROUND AND OBJECTIVE
The aim of this study was to evaluate the effect of humidified high-flow nasal cannula (HHHFNC) therapy, and compare it with the effect of nasal Continuous Positive Airway Pressure (NCPAP) in neonates with respiratory distress syndrome (RDS).
METHOD
In this clinical study, consecutively admitted 27-32 weeks preterm infants with RDS who received surfactant through a brief intubation (INSURE method) were randomly assigned immediately after extubation to HHHFNC or NCPAP. Primary outcomes were oxygen saturation values and oxygen need at 6, 12 and 24 h after surfactant administration as well as duration of oxygen and respiratory support, need for intubation and mechanical ventilation and incidence of apnea. Secondary outcomes were duration of hospitalization and incidence of complications such as pneumothorax.
RESULTS
Sixty-four infants met the inclusion criteria and were enrolled in the study, 32 per arm. Two cases in HHFNC group dropped due to congenital pneumonia/sepsis. No differences were seen between groups in primary and secondary outcomes except for arterial oxygen saturation values (SaO2) 24 h after surfactant administration that were significantly higher in the NCPAP group [95.97% ± 1.96% vs. 95.00% ± 1.80% (P = .04)] with similar oxygen needs. The treatment failure was observed in four (11.8%) infants of the NCPAP group compared to five (16.7%) cases of the HHHFNC group (P = .57).
CONCLUSION
Based on the results of the present study, the HHHFNC can be as effective as NCPAP to treat the neonates with RDS after surfactant administration.",2020,No differences were seen between groups in primary and secondary outcomes except for arterial oxygen saturation values (SaO2) 24 h after surfactant administration that were significantly higher in the NCPAP group [95.97% ± 1.96% vs. 95.00% ± 1.80% (P = .04)] with similar oxygen needs.,"['neonates with respiratory distress syndrome (RDS', 'consecutively admitted 27-32\xa0weeks preterm infants with RDS who received surfactant through a brief intubation (INSURE method', 'Sixty-four infants met the inclusion criteria and were enrolled in the study, 32 per arm', 'preterm neonates with respiratory distress syndrome']","['humidified high-flow nasal cannula (HHHFNC) therapy', 'HHFNC', 'heated humidified high flow nasal cannula and nasal continuous positive airway pressure after surfactant administration', 'HHHFNC', 'NCPAP', 'HHHFNC or NCPAP', 'nasal Continuous Positive Airway Pressure (NCPAP']","['arterial oxygen saturation values (SaO2', 'treatment failure', 'duration of hospitalization and incidence of complications such as pneumothorax', 'oxygen saturation values and oxygen need at 6, 12 and 24\xa0h after surfactant administration as well as duration of oxygen and respiratory support, need for intubation and mechanical ventilation and incidence of apnea', 'congenital pneumonia/sepsis']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0158935', 'cui_str': 'Congenital pneumonia'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",64.0,0.068706,No differences were seen between groups in primary and secondary outcomes except for arterial oxygen saturation values (SaO2) 24 h after surfactant administration that were significantly higher in the NCPAP group [95.97% ± 1.96% vs. 95.00% ± 1.80% (P = .04)] with similar oxygen needs.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbarian-Rad', 'Affiliation': 'Non-Communicable Pediatric Disease Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Avishan', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'Student Committee Research, Department of Obstetrics and Gynecology, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Khafri', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mousa', 'Initials': 'M', 'LastName': 'Ahmadpour-Kacho', 'Affiliation': 'Non-Communicable Pediatric Disease Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Yadollah', 'Initials': 'Y', 'LastName': 'Zahed-Pasha', 'Affiliation': 'Non-Communicable Pediatric Disease Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Haghshenas-Mojaveri', 'Affiliation': 'Non-Communicable Pediatric Disease Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}]",The clinical respiratory journal,['10.1111/crj.13191']
3212,32484261,Long-term effects of high-intensity training vs. moderate intensity training in heart transplant recipients: A 3-year follow-up study of the randomized controlled HITTS study.,"The randomized controlled High-Intensity Interval Training in De Novo Heart Transplant Recipients in Scandinavia (HITTS) study compared 9 months of high-intensity interval training (HIT) with moderate intensity continuous training in de novo heart transplant recipients. In our 3-year follow-up study, we aimed to determine whether the effect of early initiation of HIT on peak oxygen consumption (VO 2peak ) persisted for 2 years post-intervention. The study's primary endpoint was the change in VO 2peak (mL/kg/min). The secondary endpoints were muscle strength, body composition, heart rate response, health-related quality of life, daily physical activity, biomarkers and heart function. Of 78 patients who completed the 1-year HITTS trial, 65 entered our study and 62 completed the study tests. VO 2peak increased from baseline to 1 year and levelled off thereafter. During the intervention period, the increase in VO 2peak was larger in the HIT arm; however, 2 years later, there was no significant between-group difference in VO 2peak . However, the mean change in the anaerobic threshold and extensor muscle endurance remained significantly higher in the HIT group. Early initiation of HIT after heart transplantation appears to have some sustainable long-term effects. Clinical trial registration number: NCT01796379.",2020,"During the intervention period, the increase in VO 2peak was larger in the HIT arm; however, 2 years later, there was no significant between-group difference in VO 2peak .","['De Novo Heart Transplant Recipients in Scandinavia (HITTS', 'heart transplant recipients', '78 patients who completed the 1-year HITTS trial, 65 entered our study and 62 completed the study tests', 'in de novo heart transplant recipients']","['Intensity Interval Training', 'high-intensity interval training (HIT) with moderate intensity continuous training', 'high-intensity training vs. moderate intensity training']","['VO 2peak', 'change in VO 2peak (mL/kg/min', 'peak oxygen consumption (VO 2peak ', 'muscle strength, body composition, heart rate response, health-related quality of life, daily physical activity, biomarkers and heart function', 'anaerobic threshold and extensor muscle endurance']","[{'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0036273', 'cui_str': 'Nordic Countries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",78.0,0.0659216,"During the intervention period, the increase in VO 2peak was larger in the HIT arm; however, 2 years later, there was no significant between-group difference in VO 2peak .","[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Arne K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Yardley', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Authen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Grov', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16087']
3213,32473901,Aflibercept Reduces Retinal Hemorrhages and Intravitreal Microvascular Abnormalities But Not Venous Beading: Secondary Analysis of the CLARITY Study.,"PURPOSE
Approximately 50% of patients receiving anti-vascular endothelial growth factor (VEGF) therapy show significant improvement in diabetic retinopathy severity score (DRSS), in particular at DRSS level 47 to 53 (moderately severe to severe nonproliferative diabetic retinopathy). Level 47 to 53 consists of 3 main features: deep hemorrhages (DH), venous beading (VB), and intraretinal microvascular abnormalities (IRMAs). It is unclear whether these features respond to anti-VEGF therapies differently.
DESIGN
Post hoc analysis of Intravitreal Aflibercept versus Panretinal Photocoagulation in Patients with Proliferative Diabetic Retinopathy (CLARITY) study.
PARTICIPANTS
Treatment-naïve participants randomized to intravitreal aflibercept.
METHODS
We reanalyzed the fundus images at baseline, week 12, and week 52 to assess the changes of the 3 main features in DRSS level 47 to 53 in those patients who were treatment naïve and had received aflibercept.
MAIN OUTCOME MEASURES
Changes in DH, VB, and IRMA after aflibercept therapy at weeks 12 and 52.
RESULTS
Fifty-five treatment-naïve eyes at baseline that received aflibercept were included in the study. Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12. From 12 weeks, 32 eyes that had received injections showed improved or stable DH compared with 7 eyes that did not receive injections, and DH deteriorated in 6 eyes with no further injections compared with 4 eyes that had received more injections (P = 0.0072). Similarly, 15 eyes that continued to receive injections from week 12 showed improved or stable IRMA compared with 4 who did not receive injections (P = 0.006). Worsening of IRMA was seen in 5 eyes with no further injections compared with 4 eyes that continued to receive injections. The improvements in DH and IRMA are more likely to be maintained if less than 16 weeks have elapsed since the last anti-VEGF injection.
CONCLUSIONS
Aflibercept seems to improve DH and IRMA after just 3 injections. As soon as the frequency of injections were reduced, DH and IRMA can deteriorate again. It is unclear whether these results can be translated to patients without PDR.",2020,Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12.,"['Fifty-five treatment-naïve eyes at baseline that received', 'Patients with Proliferative Diabetic Retinopathy (CLARITY) study', 'patients without PDR']","['anti-vascular endothelial growth factor (VEGF) therapy', 'Panretinal Photocoagulation', 'aflibercept', 'intravitreal aflibercept', 'Aflibercept', 'Intravitreal Aflibercept']","['hemorrhages (DH), venous beading (VB), and intraretinal microvascular abnormalities (IRMAs', 'Severe DH and severe IRMA', 'Worsening of IRMA', 'stable DH', 'Retinal Hemorrhages and Intravitreal Microvascular Abnormalities', 'stable IRMA', 'Changes in DH, VB, and IRMA', 'diabetic retinopathy severity score (DRSS', 'DH and IRMA']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C2939143', 'cui_str': 'Retinal veins beaded'}, {'cui': 'C3714733', 'cui_str': 'Intraretinal microvascular abnormality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021073', 'cui_str': 'Immunoradiometric Assays'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035317', 'cui_str': 'Retinal hemorrhage'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",6.0,0.0642177,Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pearce', 'Affiliation': 'Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom. Electronic address: liz.pearce@boehringer-ingelheim.com.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chong', 'Affiliation': 'Boehringer Ingelheim International GmBH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.02.003']
3214,32473928,Short-term interval exercise suppresses acylated ghrelin and hunger during caloric restriction in women with obesity.,"Caloric restriction is suggested to increase hunger, in part, through complex interactions of hormones and behavior that contribute to challenges in long-term weight loss. Although intense exercise may attenuate appetite, no data exist testing the effects of interval exercise (INT) during a low-calorie diet (LCD) on appetite regulation. We hypothesized that LCD+INT would favorably influence satiety when compared with an energy-deficit matched LCD in women with obesity. Twenty-six women with obesity (47.3±2.4 yrs; 37.3 ± 1.2 kg/m 2 ) were randomized to either LCD (n = 13; mixed meals of ~1200 kcal/d) or LCD+INT (n = 13; 60 min/d of supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak for 3 min) for 2 weeks. An additional 350kcal (shake) was provided to LCD+INT individuals post-exercise to equate energy availability between groups. Total PYY, acylated ghrelin and des-ghrelin were measured at 0, 30 and 60 min of a 75g OGTT before and after the intervention. Visual analog scales were also administered at 0 and 120 min of the OGTT to assess appetite perception. Food logs were recorded prior to and during the intervention to ensure caloric intake compliance. Compared with pre-intervention conditions, both interventions decreased food intake (P = 0.001) and body fat (P < 0.01). There was no effect on fasting PYY, but both LCD and LCD+INT increased post-prandial PYY iAUC (P < 0.001) relative to pre-intervention. LCD+INT maintained fasting acylated ghrelin (P = 0.06) and suppressed post-prandial acylated ghrelin iAUC (P = 0.04) compared to LCD. Neither intervention impacted circulating des- ghrelin before or following the OGTT. Interestingly, LCD+INT attenuated fasting hunger and maintained fullness compared with LCD (P = 0.05 and P = 0.06, respectively). Taken together, interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD in women with obesity.",2020,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","['women with obesity', 'Twenty-six women with obesity (47.3±2.4 yrs; 37.3±1.2 kg/m 2 ']","['interval exercise (INT', 'LCD+INT', 'Short-term interval exercise', 'LCD', 'supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak', 'interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD']","['Total PYY, acylated ghrelin and des-ghrelin', 'appetite perception', 'food intake', 'Visual analog scales', 'fasting hunger and maintained fullness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",26.0,0.0280904,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States; Division of Endocrinology & Metabolism, University of Virginia, Charlottesville, VA, United States; Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, VA, United States. Electronic address: skm6n@virginia.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112978']
3215,32473959,A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers.,"Few trial data are available concerning the impact of personalised cancer risk information on behaviour. This study assessed the short-term effects of providing personalised cancer risk information on cancer risk beliefs and self-reported behaviour. We randomised 1018 participants, recruited through the online platform Prolific, to either a control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice. The primary outcome was change from baseline in computed risk relative to an individual with a recommended lifestyle (RRI) at three months. Secondary outcomes included: health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction. After three months there were no between-group differences in change in RRI (p = 0.71). At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group. The increases in accuracy and conviction were only seen in individuals with high numeracy and low baseline conviction, respectively. These findings suggest that personalised cancer risk information alongside lifestyle advice can increase short-term risk accuracy and conviction without increasing worry or anxiety but has little impact on health-related behaviour. Trial registration: ISRCTN17450583. Registered 30 January 2018.",2020,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","['1018 participants, recruited through the online platform Prolific, to either a']","['control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice', 'personalised cancer risk information', 'online risk information and lifestyle advice']","['computed risk relative to an individual with a recommended lifestyle (RRI', 'accuracy and conviction', 'health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction', 'accuracy of absolute risk perception', 'absolute and comparative risk conviction', 'change in RRI', 'intention to increase fruit and vegetables', 'cancer risk beliefs and self-reported behaviour']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C1547273', 'cui_str': 'Preventable'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",1018.0,0.105156,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","[{'ForeName': 'Golnessa', 'Initials': 'G', 'LastName': 'Masson', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: gh453@medschl.cam.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: kmills@medschl.cam.ac.uk.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge CB2 0QQ, UK. Electronic address: stephen.sharp@mrc-epid.cam.ac.uk.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'National Cancer Institute, Rockville, MD, USA. Electronic address: kleinwm@mail.nih.gov.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Behavioural Science Group, The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: srs34@medschl.cam.ac.uk.'}, {'ForeName': 'Juliet A', 'Initials': 'JA', 'LastName': 'Usher-Smith', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: jau20@medschl.cam.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106154']
3216,32474473,Supplementation with Matured Hop Bitter Acids Improves Cognitive Performance and Mood State in Healthy Older Adults with Subjective Cognitive Decline.,"BACKGROUND
Prevention of age-related cognitive decline and depression is becoming urgent because of rapid growing aging populations. Effects of vagal nerve activation on brain function by food ingredients are inadequately investigated; matured hop bitter acid (MHBA) administration reportedly improves cognitive function and depression via vagal nerve activation in model mice.
OBJECTIVE
We investigated the effects of MHBA supplementation on cognitive function and mood state in healthy older adults with perceived subjective cognitive decline.
METHODS
Using a randomized double-blind placebo-controlled trial design, 100 subjects (aged 45-69 years) were randomly assigned into placebo (n = 50) and MHBA (n = 50) groups, and received placebo or MHBA capsules daily for 12 weeks.
RESULTS
Symbol Digit Modalities Test (SDMT) score assessing divided attention at week 12 was significantly higher (p = 0.045) and β-endorphin at week 12 was significantly lower (p = 0.043) in the subjects receiving MHBA. Transthyretin in serum, a putative mild cognitive impairment marker, was significantly higher at week 12 in the MHBA group than in the placebo group (p = 0.048). Subgroup analysis classified by the subjective cognitive decline questionnaire revealed that in addition to improved SDMT scores, memory retrieval assessed using the standard verbal paired-associate learning tests and the Ray Verbal Learning Test at week 12 had significantly improved in the subgroup with perceived subjective cognitive decline and without requirement for medical assistance in the MHBA group compared with that in the placebo group.
CONCLUSION
This study suggested that MHBA intake improves cognitive function, attention, and mood state in older adults.",2020,"Transthyretin in serum, a putative mild cognitive impairment marker, was significantly higher at week 12 in the MHBA group than in the placebo group (p = 0.048).","['100 subjects (aged 45-69 years', 'older adults', 'healthy older adults with perceived subjective cognitive decline', 'Healthy Older Adults with Subjective Cognitive Decline']","['vagal nerve activation', 'MHBA supplementation', 'placebo or MHBA capsules daily for 12 weeks', 'Supplementation with Matured Hop Bitter Acids', 'MHBA', 'placebo']","['Symbol Digit Modalities Test (SDMT) score assessing divided attention', 'SDMT scores, memory retrieval assessed using the standard verbal paired-associate learning tests and the Ray Verbal Learning Test', 'cognitive function, attention, and mood state', 'subjective cognitive decline and without requirement for medical assistance', 'cognitive function and mood state', 'Transthyretin in serum, a putative mild cognitive impairment marker', 'Cognitive Performance and Mood State', 'β-endorphin']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]","[{'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0589101', 'cui_str': 'Divided attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0030210', 'cui_str': 'Paired-Associate Learning'}, {'cui': 'C0086894', 'cui_str': 'Rajiformes'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0025070', 'cui_str': 'Assistance, Medical'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}]",100.0,0.48803,"Transthyretin in serum, a putative mild cognitive impairment marker, was significantly higher at week 12 in the MHBA group than in the placebo group (p = 0.048).","[{'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Fukuura, Kanazawa-ku, Yokohama, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Ohnuma', 'Affiliation': 'Department of Psychiatry, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Obara', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Fukuura, Kanazawa-ku, Yokohama, Japan.'}, {'ForeName': 'Sumio', 'Initials': 'S', 'LastName': 'Kondo', 'Affiliation': 'Fukushima Healthcare Center, Fukushima-ku, Osaka, Japan.'}, {'ForeName': 'Heii', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'Department of Psychiatry, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Ano', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Fukuura, Kanazawa-ku, Yokohama, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200229']
3217,32474507,Para-aortic lymph node tracing and dissection in advanced gastric cancer: Effectiveness of carbon nanoparticles injection through the no. 12b lymph node.,"Background and Objectives
The relative effectiveness of tracers in guiding para-aortic lymph node dissection (PAND) in advanced gastric cancer is undefined. In this single-center, prospective study, we aimed to discuss the effectiveness of such tracers.
Materials and Methods
Between January 2015 and January 2016, 90 consecutive patients with stage T4a gastric cancer were evenly assigned to receive 0.2 mL of carbon nanoparticles (a), methylene blue (b), or no tracer (c) injection through no. 12b lymph nodes before PAND.
Results
There was no difference in the baseline characteristics between the three groups. Group A vs. B or C had a higher number of dissected lymph nodes (34.1 ± 9.8, 25.5 ± 5.5, and 22.6 ± 3.7; P < 0.001; B vs. C: P =0.321) and no. 16a2/b1 para-aortic lymph nodes (PANs; 11.8 ± 4.8, 7.0 ± 1.2, and 5.5 ± 1.2; P < 0.001; B vs. C: P =0.178) and similar rates of lymph node metastasis (20.9 ± 17.5%, 19.1 ± 15.1%, and 23.6 ± 19.7%; P = 0.511), positive dissected PAN (23.3% [7/30], 16.7% [5/30], and 16.7% [5/30]), surgery duration (252.9 + 35.4, 244.4 ± 29.0, and 250.3 + 29.9 min; P = 0.421), and blood loss (266.7 ± 115.5, 270.0 ± 82.6, and 260.0 ± 116.3 mL, P = 0.933). There was no common bile duct damage by tracer injection, and one case of duodenal stump fistula, one abdominal infection, and two anastomotic leakages in Groups A-C, respectively, were treated successfully.
Conclusions
In advanced gastric cancer treatment, carbon nanoparticle injection into no. 12b nodes appears to better trace no. 16a2/b1 PAN.",2020,"There was no common bile duct damage by tracer injection, and one case of duodenal stump fistula, one abdominal infection, and two anastomotic leakages in Groups A-C, respectively, were treated successfully.
","['advanced gastric cancer', 'Between January 2015 and January 2016, 90 consecutive patients with stage T4a gastric cancer']","['carbon nanoparticles (a), methylene blue (b), or no tracer (c) injection through no. 12b lymph nodes before PAND', 'carbon nanoparticles injection']","['number of dissected lymph nodes', 'positive dissected PAN', 'surgery duration', 'blood loss', 'rates of lymph node metastasis']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0475395', 'cui_str': 'Tumor stage T4a'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0229789', 'cui_str': 'Structure of aortic lymph node'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}]",90.0,0.0505995,"There was no common bile duct damage by tracer injection, and one case of duodenal stump fistula, one abdominal infection, and two anastomotic leakages in Groups A-C, respectively, were treated successfully.
","[{'ForeName': 'Guangchuan', 'Initials': 'G', 'LastName': 'Mu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Zhibai', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Xingan', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Biomedical Engineering Center, Beijing University of Technology, Beijing, China.'}]",Journal of cancer research and therapeutics,['10.4103/jcrt.JCRT_506_19']
3218,32474564,Oral S-1 with 24-h Infusion of Irinotecan plus Bevacizumab versus FOLFIRI plus Bevacizumab as First-Line Chemotherapy for Metastatic Colorectal Cancer: An Open-Label Randomized Phase II Trial.,"BACKGROUND
FOLFIRI plus bevacizumab have been widely used as first-line treatment for metastatic colorectal cancer (mCRC). Pharmacokinetics and pharmacodynamics suggested a low dose of irinotecan given as a long-term infusion is expected to enhance antitumor activity. We conducted a randomized phase II study to compare oral S-1 with a 24-h infusion of irinotecan plus bevacizumab versus FOLFIRI plus bevacizumab.
METHODS
The subjects comprised 120 chemotherapy-naïve patients with mCRC. The study group received a 24-h infusion of irinotecan at a dose of 125 mg/m2 on days 1 and 15, combined with oral S-1 80 mg/m2 on days 1-14 (24h-SIRI/B). The FOLFIRI/B group received irinotecan at a dose of 150 mg/m2, 5-fluorouracil given at a dose of 400 mg/m2 as a bolus injection and at a dose of 2,400 mg/m2 as a 46-h infusion, and 200 mg/m2 leucovorin on days 1 and 15. Bevacizumab was given at a dose of 5.0 mg/kg on days 1 and 15 in both groups. Treatment was repeated every 4 weeks. The primary endpoint was 1-year progression-free survival (PFS). Secondary endpoints were PFS, response rates (RR), overall survival (OS), and adverse events (AEs).
RESULTS
From December 2013 through January 2018, 120 patients were randomly assigned, 61 patients to the 24h-SIRI/B and 59 patients to the FOLFIRI/B. The median follow-up period was 22.8 months. The 1-year PFS rate was 43.14% in the 24h-SIRI/B arm and 19.15% in the FOLFIRI/B arm (HR = 0.312 [95%CI 0.13-0.78], p = 0.01). The median PFS was 10.2 months (95%CI 8.8-14.3) and 10.0 months (95%CI 7.4-11.0), and the median OS was 29.7 months (95%CI 22.9-43.9) and 28.8 months (95%CI 18.4-ND), respectively (p = 0.3758, p = 0.8234). The overall RR was 86.3 and 61.7%, respectively (p = 0.0053). AEs were similar.
CONCLUSIONS
Our results show that the 24h-SIRI/B regimen is an effective and reasonably well-tolerated regimen for the first-line treatment of mCRC.",2020,"The overall RR was 86.3 and 61.7%, respectively (p = 0.0053).","['metastatic colorectal cancer (mCRC', 'Metastatic Colorectal Cancer', 'From December 2013 through January 2018', 'subjects comprised 120 chemotherapy-naïve patients with mCRC', '120 patients were randomly assigned, 61 patients to the 24h-SIRI/B and 59 patients to the FOLFIRI/B']","['leucovorin', 'Bevacizumab', 'Irinotecan plus Bevacizumab versus FOLFIRI plus Bevacizumab', 'irinotecan plus bevacizumab versus FOLFIRI plus bevacizumab', '5-fluorouracil', 'irinotecan', 'bevacizumab']","['median OS', '1-year PFS rate', 'PFS, response rates (RR), overall survival (OS), and adverse events (AEs', '1-year progression-free survival (PFS', 'overall RR', 'median PFS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.214759,"The overall RR was 86.3 and 61.7%, respectively (p = 0.0053).","[{'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Sadahiro', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan, sadahiro@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Kazutake', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Gota', 'Initials': 'G', 'LastName': 'Saito', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyakita', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogimi', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Lin Fung', 'Initials': 'LF', 'LastName': 'Chan', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Kamei', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}]",Oncology,['10.1159/000507293']
3219,32474728,Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.,"BACKGROUND AND OBJECTIVE
Dabigatran etexilate is a non-vitamin K antagonist oral anticoagulant (NOAC) that is used to prevent stroke and systemic embolism in adults with nonvalvular atrial fibrillation (NVAF) and one or more risk factors. Pharmacokinetic data on this anticoagulant in Chinese subjects are limited. This study aimed to provide further information on the pharmacokinetic profile of dabigatran in healthy Chinese subjects, together with its safety profile.
METHODS
This was an open-label, single-centre, phase I study. Subjects were randomized into 110 and 150 mg dabigatran etexilate treatment groups. Each subject received 7 days of treatment: a single dose on day 1, no dose on days 2-3, and then multiple doses on days 4-10. Blood samples were collected to analyze the pharmacokinetic profile of dabigatran. All adverse events (AEs) were recorded. Routine clinical laboratory tests, a physical examination, vital signs, and 12-lead electrocardiogram (ECG) measurements were performed.
RESULTS
A total of 28 subjects (14 males and 14 females) were randomized in this trial. The plasma concentration of total dabigatran reached its maximum measured concentration at a median time of 3-4 h from the dose of interest (either the initial single dose on day 1 or the final dose on day 10) under fed conditions, and declined with an elimination half-life of 10.7-10.9 h following the dose of interest. There was a modest difference in pharmacokinetic profile between male and female subjects. None of the subjects experienced a serious adverse event (SAE) or an AE of moderate or severe intensity. The investigator reported that 17 of the 28 subjects had mild treatment-emergent AEs that resolved without any concomitant treatment or intervention. No clinically significant changes in vital signs or ECG parameters were observed.
CONCLUSIONS
This study revealed the pharmacokinetic characteristics and good safety profile of dabigatran in healthy Chinese subjects.",2020,"No clinically significant changes in vital signs or ECG parameters were observed.
","['Chinese subjects', 'Healthy Chinese Subjects', '28 subjects (14 males and 14 females', 'healthy Chinese subjects', 'male and female subjects', 'adults with nonvalvular atrial fibrillation (NVAF']","['vitamin K antagonist oral anticoagulant (NOAC', 'dabigatran etexilate', 'dabigatran', 'Dabigatran Etexilate']","['serious adverse event (SAE) or an AE of moderate or severe intensity', 'plasma concentration of total dabigatran', 'physical examination, vital signs, and 12-lead electrocardiogram (ECG) measurements', 'pharmacokinetic profile', 'vital signs or ECG parameters']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",28.0,0.0820733,"No clinically significant changes in vital signs or ECG parameters were observed.
","[{'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Pharmacy, Peking University Third Hospital, Peking, China. duanjingli@pkuih.edu.cn.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pharmacy, Peking University Third Hospital, Peking, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular, Peking University Third Hospital, Peking, China.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Yamamura', 'Affiliation': 'Department of Clinical Pharmacokinetics/Pharmacodynamics, Nippon Boehringer Ingelheim Co., Ltd., Kobe, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Harada', 'Affiliation': 'Department of Clinical Pharmacokinetics/Pharmacodynamics, Nippon Boehringer Ingelheim Co., Ltd., Kobe, Japan.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00626-4']
3220,32474918,"An open label cluster randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19 (ARCHAIC) - Protocol publication.","Chloroquine (CQ) and hydroxychloroquine (HCQ) were both employed in the treatment of COVID-19 in China. Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in moderate to severe COVID-19.",2020,"Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in moderate to severe COVID-19.","['patients admitted with moderate to severe COVID-19 (ARCHAIC) - Protocol publication', 'COVID-19 in China']","['Chloroquine (CQ) and hydroxychloroquine (HCQ', 'chloroquine, hydroxychloroquine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0514377,"Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in moderate to severe COVID-19.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Weehuizen', 'Affiliation': 'Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'A I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}]",European journal of clinical investigation,['10.1111/eci.13297']
3221,32474935,Soft tissue healing around platform-switching and platform-matching single implants: A randomized clinical trial.,"BACKGROUND
Implants with platform-switching (PS) design have been demonstrated to reduce marginal bone loss. However, the influence on peri-implant soft tissue healing is unclear. This study was designed to investigate its effect on peri-implant soft tissue healing after implant uncovery.
METHODS
Non-smokers needing two implants in different quadrants were recruited in this study. For each individual, one PS and one platform-matching (PM) implants were placed using 2-stage protocol. Following 2-8 months of healing, all implants were uncovered and connected to the corresponding healing abutments. Clinical measurements and peri-implant crevicular fluid (PICF) were taken at 1-, 2-, 4-, and 6-week after 2 nd stage surgery. The cytokine concentrations in PICF were analyzed. Peri-implant mucosa (1 × 2 × 2mm) was harvested around the healing abutment for the analysis of gene expression at uncovery and 6-week post-uncovery.
RESULTS
18 participants (9 males; 51.7±14.9 years) were recruited. Compared to PM, PS showed significantly lower probing depth (PD) at 1- and 2-week as well as modified sulcus bleeding index (mSBI) at 1-, 4- and 6-week (P<0.05). Over time, a decrease in osteoprotegerin and Interleukin-1β concentrations in PICF along with an increase in receptor activator of unclear factor kappa-B ligand, periostin and peroxidasin gene expressions in peri-implant mucosa were noted within both groups (P<0.05) without significant intergroup differences.
CONCLUSION
Within the limits, implants with PS design rendered significant benefits over PM design in PD and mSBI reduction during a 6-week healing. However, molecular changes within PICF and peri-implant mucosa as a response to PM and PS appear negligible. This article is protected by copyright. All rights reserved.",2020,"Over time, a decrease in osteoprotegerin and Interleukin-1β concentrations in PICF along with an increase in receptor activator of unclear factor kappa-B ligand, periostin and peroxidasin gene expressions in peri-implant mucosa were noted within both groups (P<0.05) without significant intergroup differences.
","['18 participants (9 males; 51.7±14.9 years) were recruited', 'Non-smokers needing two implants in different quadrants']","['Soft tissue healing around platform-switching and platform-matching single implants', 'platform-switching (PS']","['modified sulcus bleeding index (mSBI', 'probing depth (PD', 'marginal bone loss', 'receptor activator of unclear factor kappa-B ligand, periostin and peroxidasin gene expressions in peri-implant mucosa', 'osteoprotegerin and Interleukin-1β concentrations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C4543210', 'cui_str': 'Receptor activator'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0219433', 'cui_str': 'POSTN protein, human'}, {'cui': 'C0258286', 'cui_str': 'peroxidasin'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",18.0,0.0499183,"Over time, a decrease in osteoprotegerin and Interleukin-1β concentrations in PICF along with an increase in receptor activator of unclear factor kappa-B ligand, periostin and peroxidasin gene expressions in peri-implant mucosa were noted within both groups (P<0.05) without significant intergroup differences.
","[{'ForeName': 'Guo-Liang', 'Initials': 'GL', 'LastName': 'Cheng', 'Affiliation': 'Graduate Periodontics, Department of Oral Health and Rehabilitation, School of Dentistry, University of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Binnaz', 'Initials': 'B', 'LastName': 'Leblebicioglu', 'Affiliation': 'Division of Periodontology, College of Dentistry, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Veterinary Biosciences, College of Veterinary Medicine, The Ohio State University, Ohio, USA.'}, {'ForeName': 'Hua-Hong', 'Initials': 'HH', 'LastName': 'Chien', 'Affiliation': 'Division of Periodontology, College of Dentistry, The Ohio State University, Columbus, Ohio, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0030']
3222,32474978,"""I don't think I took her fears seriously."" Exploring the experiences of family members of individuals at-risk of developing psychosis over 12-months.","Individuals with an At Risk Mental State (ARMS) of psychosis experience high-levels of distress, anxiety, low mood and suicidal ideation. Families of ARMS individuals provide significant support but are often neglected by services. This study is the first of its kind to use a novel longitudinal qualitative methodology to directly compare family/carers earlier experiences supporting ARMS individuals to 12-months later. This provides a more ecologically valid insight into how perceptions change over time and how family/carers adapt. Semi-structured interviews were conducted with ten family/carers at two points within a 12-month period. This study was embedded within a randomised control trial, the Individual and Family Cognitive Behavioural Therapy (IFCBT) trial. Interview transcripts were analysed using thematic analysis, with a focus on how experiences and reactions for family/carers changed over time. Over 12-months, four factors were important for family/carers to facilitate their caring role. These were summarised in the thematic map (LACE model): Looking after your own wellbeing; Accessing additional support from family intervention; Communicating openly with the individual; Engaging with services for the individual. All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs and helping them to feel more confident and less isolated in their carer role. Novel implications suggest that when feasible, services should involve family/carers of ARMS individuals in sessions and explore family/carer support strategies in managing their own distress. The most significant insight was the need to develop family/carer resources to educate, normalise and validate their own experiences.",2020,"All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs and helping them to feel more confident and less isolated in their carer role.","['Individuals with an At Risk Mental State (ARMS) of psychosis experience high-levels of distress, anxiety, low mood and suicidal ideation']",['Individual and Family Cognitive Behavioural Therapy (IFCBT'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0176856,"All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs and helping them to feel more confident and less isolated in their carer role.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Izon', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Berry', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Law', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Pennine Care NHS Foundation Trust, Lancashire, United Kingdom.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2483']
3223,32475050,Impact of age on clinical outcomes of antihypertensive therapy in patients with hypertension and coronary artery disease: A sub-analysis of the Heart Institute of Japan Candesartan Randomized Trial for Evaluation in Coronary Artery Disease.,"This study aimed to determine whether different systolic blood pressure (SBP) measurements achieved with antihypertensive therapy impact clinical outcomes by age in patients with hypertension and coronary artery disease (CAD). This post hoc analysis from the Heart Institute of Japan Candesartan Randomized Trial for Evaluation in Coronary Heart Disease (HIJ-CREATE) trial included 2048 patients with hypertension and angiographically documented CAD. Participants were divided into three groups based on age at enrollment: middle-aged (<60 years, n = 570), pre-elderly (≥60-<70 years, n = 730), and elderly (≥70 years, n = 748). Among the 2,048 patients, 1695 (82.7%) underwent percutaneous coronary intervention. The primary end point was the time to first occurrence of a major adverse cardiac event (MACE). During a median follow-up of 4.2 years, the MACE rate was 19.8%, 28.1%, and 31.1% in the middle-aged, pre-elderly, and elderly groups, respectively. Achieved BP was defined as the mean BP during scheduled visits. Patients with higher achieved SBP had a higher occurrence of MACE in all age groups. An unadjusted quadratic proportional hazard model was used to evaluate the relationship between achieved BP during follow-up and risk for MACE. In each age group, participants were divided into quartiles based on the achieved BP during follow-up. The relationship between achieved SBP and the incidence of MACE did not follow a J-shaped curve in any age group. In conclusion, in the contemporary era of aggressive coronary revascularization, a lower SBP target may be appropriate even in elderly patients with hypertension and CAD.",2020,The relationship between achieved SBP and the incidence of MACE did not follow a J-shaped curve in any age group.,"['patients with hypertension and coronary artery disease (CAD', 'patients with hypertension and coronary artery disease', '2,048 patients, 1695 (82.7%) underwent', 'Participants were divided into three groups based on age at enrollment: middle-aged (<60\xa0years, n\xa0=\xa0570), pre-elderly (≥60-<70\xa0years, n\xa0=\xa0730), and elderly (≥70\xa0years, n\xa0=\xa0748', 'elderly patients with hypertension and CAD', '2048 patients with hypertension and angiographically documented CAD']","['antihypertensive therapy', 'percutaneous coronary intervention']","['time to first occurrence of a major adverse cardiac event (MACE', 'MACE rate', 'Achieved BP', 'mean BP', 'systolic blood pressure (SBP) measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",2048.0,0.0261546,The relationship between achieved SBP and the incidence of MACE did not follow a J-shaped curve in any age group.,"[{'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kikuchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Jujo', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Sekiguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13891']
3224,32475079,Mepitel Film is superior to Biafine cream in managing acute radiation-induced skin reactions in head and neck cancer patients: a randomised intra-patient controlled clinical trial.,"INTRODUCTION
We previously showed that Mepitel Film decreased the severity of acute radiation-induced skin reactions in head and neck cancer patients. In the current study, we compared the effect of Mepitel Film and Biafine cream on skin reaction severity in a larger cohort of head and neck cancer patients.
METHODS
A total of 44 head and neck cancer patients were recruited with 39 patients contributing full data sets for analysis. Patients received a dose of 50 Gy in 25 fractions to the bilateral lymph nodes in the neck. Left and right lymph node areas were randomised to either Mepitel Film or Biafine cream, applied prophylactically. Skin reaction severity was measured using Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and expanded Radiation Oncology group (RTOG) grades. Skin dose was measured using gafchromic Film.
RESULTS
Skin reaction severity (combined RISRAS score) underneath Mepitel Film was decreased by 30% (P < 0.001) and moist desquamation rates by 41% (P < 0.001). Skin dose underneath Mepitel Film and Biafine cream was similar (P = 0.925) and unlikely to have affected skin reaction severity. The vast majority (80%) of patients preferred Mepitel Film over Biafine cream. Negative aspects of Mepitel Film included poor adherence (11/39) and discomfort (16/39) during hot weather and showering and itchy skin underneath Mepitel Film (12/39).
CONCLUSIONS
Mepitel Film was superior to Biafine cream in reducing the severity of acute radiation-induced skin reactions and moist desquamation incidence in our head and neck patient cohort.",2020,Skin dose underneath Mepitel Film and Biafine cream was similar (P = 0.925) and unlikely to have affected skin reaction severity.,"['larger cohort of head and neck cancer patients', 'head and neck cancer patients', 'Left and right lymph node areas', '44 head and neck cancer patients were recruited with 39 patients contributing full data sets for analysis']","['Biafine cream', 'Skin dose underneath Mepitel Film and Biafine cream', 'Mepitel Film or Biafine cream', 'Mepitel Film and Biafine cream']","['Skin reaction severity (combined RISRAS score) underneath Mepitel Film', 'severity of acute radiation-induced skin reactions', 'skin reaction severity', 'Radiation-Induced Skin Reaction Assessment Scale (RISRAS', 'Skin reaction severity', 'moist desquamation rates']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0677828', 'cui_str': 'Biafine'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0758246', 'cui_str': 'mepitel'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0758246', 'cui_str': 'mepitel'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]",,0.0289646,Skin dose underneath Mepitel Film and Biafine cream was similar (P = 0.925) and unlikely to have affected skin reaction severity.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Shuangshuang', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Mengdi', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Kongcheng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand.'}]",Journal of medical radiation sciences,['10.1002/jmrs.397']
3225,32475085,The Weight Optimization Revamping Lifestyle using the Dietary Guidelines (WORLD) Study: Sustained Weight Loss Over 12 Months.,"OBJECTIVE
This study aimed to compare two energy-restricted, nutrient-dense diets at the upper or lower ends of the dietary fat recommendation range (lower fat [20% energy from fat] versus moderate fat [35%]) on weight loss using behavioral theory-based nutrition education.
METHODS
A total of 101 premenopausal women with overweight or obesity were randomized to an energy-restricted lower-fat or moderate-fat diet for 1 year. Interventions included 28 behavioral theory-based nutrition education sessions plus weekly exercise sessions.
RESULTS
Both treatment groups experienced weight loss (-5.0 kg for lower fat and -4.3 kg for moderate fat; P < 0.0001), but there was no difference in weight loss or fat intake between groups. Total and low-density lipoprotein cholesterol decreased (-3. 4 mg/dL and -3.8 mg/dL; P < 0.05), and high-density lipoprotein cholesterol increased (1.9 mg/dL; P < 0.05) in both groups at 12 months. Diet quality, assessed by the Healthy Eating Index, increased significantly at 4 months versus baseline (70.8 [0.9] vs. 77.8 [1.0]) and was maintained through 12 months. Higher Healthy Eating Index scores were associated with greater weight loss at 4 months (r = -0.2; P < 0.05).
CONCLUSIONS
In the context of a well-resourced, free-living weight-loss intervention, total fat intake did not change; however, theory-based nutrition education underpinned by food-based recommendations resulted in caloric deficits, improvements in diet quality, and weight loss that was sustained for 1 year.",2020,"Higher Healthy Eating Index scores were associated with greater weight loss at 4 months (r = -0.2; P < 0.05).
",['101 premenopausal women with overweight or obesity'],"['28 behavioral theory-based nutrition education sessions plus weekly exercise sessions', 'energy-restricted lower-fat or moderate-fat diet for 1 year']","['Weight Loss', 'Diet quality', 'diet quality, and weight loss', 'high-density lipoprotein cholesterol', 'weight loss', 'Healthy Eating Index', 'weight loss or fat intake', 'Higher Healthy Eating Index scores', 'Total and low-density lipoprotein cholesterol']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301585', 'cui_str': 'Fat diet'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",101.0,0.0236992,"Higher Healthy Eating Index scores were associated with greater weight loss at 4 months (r = -0.2; P < 0.05).
","[{'ForeName': 'Tricia L', 'Initials': 'TL', 'LastName': 'Psota', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Tindall', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lohse', 'Affiliation': 'Wegmans School of Health and Nutrition, Rochester Institute of Technology, Rochester, New York, USA.'}, {'ForeName': 'Paige E', 'Initials': 'PE', 'LastName': 'Miller', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22824']
3226,32475095,Efficacy and Safety of Abdominal Trunk Muscle Strengthening Using an Innovative Device in Elderly Patients With Chronic Low Back Pain: A Pilot Study.,"Objective
To examine the efficacy and safety of an innovative, device-driven abdominal trunk muscle strengthening program, with the ability to measure muscle strength, to treat chronic low back pain (LBP) in elderly participants.
Methods
Seven women with non-specific chronic LBP, lasting at least 3 months, were enrolled and treated with the prescribed exercise regimen. Patients participated in a 12-week device-driven exercise program which included abdominal trunk muscle strengthening and 4 types of stretches for the trunk and lower extremities. Primary outcomes were adverse events associated with the exercise program, improvement in abdominal trunk muscle strength, as measured by the device, and improvement in the numerical rating scale (NRS) scores of LBP with the exercise. Secondary outcomes were improvement in the Roland-Morris Disability Questionnaire (RDQ) score and the results of the locomotive syndrome risk test, including the stand-up and two-step tests.
Results
There were no reports of increased back pain or new-onset abdominal pain or discomfort during or after the device-driven exercise program. The mean abdominal trunk muscle strength, NRS, RDQ scores, and the stand-up and two-step test scores were significantly improved at the end of the trial compared to baseline.
Conclusion
No participants experienced adverse events during the 12-week strengthening program, which involved the use of our device and stretching, indicating the program was safe. Further, the program significantly improved various measures of LBP and physical function in elderly participants.",2020,There were no reports of increased back pain or new-onset abdominal pain or discomfort during or after the device-driven exercise program.,"['Elderly Patients With Chronic Low Back Pain', 'elderly participants', 'Seven women with non-specific chronic LBP, lasting at least 3 months, were enrolled and treated with the prescribed exercise regimen']","['innovative, device-driven abdominal trunk muscle strengthening program', 'Abdominal Trunk Muscle', 'device-driven exercise program which included abdominal trunk muscle strengthening and 4 types of stretches for the trunk and lower extremities', 'Strengthening Using an Innovative Device']","['back pain or new-onset abdominal pain or discomfort', 'Roland-Morris Disability Questionnaire (RDQ) score and the results of the locomotive syndrome risk test, including the stand-up and two-step tests', 'adverse events associated with the exercise program, improvement in abdominal trunk muscle strength, as measured by the device, and improvement in the numerical rating scale (NRS) scores of LBP with the exercise', 'LBP and physical function', 'efficacy and safety', 'mean abdominal trunk muscle strength, NRS, RDQ scores, and the stand-up and two-step test scores', 'adverse events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4087189', 'cui_str': 'Locomotive syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",7.0,0.0363891,There were no reports of increased back pain or new-onset abdominal pain or discomfort during or after the device-driven exercise program.,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Demura', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Shinmura', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Yokogawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Noritaka', 'Initials': 'N', 'LastName': 'Yonezawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}]",Annals of rehabilitation medicine,['10.5535/arm.19100']
3227,32475229,Comparison of two needles arthrocentesis versus double needle cannula arthrocentesis in the treatment of temporomandibular disc displacement.,"OBJECTIVE
To compare clinical and imaging results of two needles arthrocentesis (TNA) versus double-needle cannula arthrocentesis (DNCA) in the treatment of temporomandibular joint disc displacement (DD).
METHODS
Twenty patients with DD were randomly divided into two groups: TNA and DNCA. Clinical data (pain scores; maximal interincisal distance [MID], and protrusion and laterality movements) were evaluated before and 24 months after the arthrocentesis. Disc and condyle position and joint effusion (JE) were evaluated by magnetic resonance exams.
RESULTS
Both groups presented improvement in the MID, including pain reduction, modifications in disc and condyle positions, and reduction of the presence of JE, without difference between groups ( p > 0.05). The DNCA was performed significantly faster ( p = 0.0001).
CONCLUSION
Both TNA and DNCA are efficient in promoting improvement in the MID: reduction in pain, modifications in disc and condyle positions, and, in part, may account for less JE, without difference between techniques.",2020,"The DNCA was performed significantly faster ( p = 0.0001).
","['temporomandibular disc displacement', 'temporomandibular joint disc displacement (DD', 'Twenty patients with DD']","['two needles arthrocentesis (TNA) versus double-needle cannula arthrocentesis (DNCA', 'needles arthrocentesis versus double needle cannula arthrocentesis', 'TNA and DNCA']","['Disc and condyle position and\xa0joint effusion (JE', 'Clinical data (pain scores; maximal interincisal distance [MID], and protrusion and laterality movements', 'MID, including pain reduction, modifications in disc and condyle positions, and reduction of the presence of JE']","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C1290686', 'cui_str': 'Temporomandibular joint disc displacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0524414', 'cui_str': 'Structure of condyle'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C1253936', 'cui_str': 'Effusion of joint'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0023114', 'cui_str': 'Handedness'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",20.0,0.0425432,"The DNCA was performed significantly faster ( p = 0.0001).
","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grossmann', 'Affiliation': 'Department of Dentistry, Federal University of Rio Grande do Sul , Porto Alegre, Brazil.'}, {'ForeName': 'Luciano Ambrosio', 'Initials': 'LA', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medical and Health Sciences of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Rodrigo Lorenzi', 'Initials': 'RL', 'LastName': 'Poluha', 'Affiliation': 'Bauru School of Dentistry, University of São Paulo , Bauru, Brazil.'}, {'ForeName': 'Enio', 'Initials': 'E', 'LastName': 'Setogutti', 'Affiliation': 'Private Clinic , Porto Alegre, Brazil.'}, {'ForeName': 'Lilian Cristina Vessoni', 'Initials': 'LCV', 'LastName': 'Iwaki', 'Affiliation': 'Radiology and Stomatology, Department of Dentistry, State University of Maringá , Maringá, Brazil.'}, {'ForeName': 'Liogi', 'Initials': 'L', 'LastName': 'Iwaki Filho', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Dentistry, State University of Maringá , Maringá, Brazil.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2020.1773601']
3228,32475246,Fixation of the short global tissue-sparing hip stem.,"AIMS
Short, bone-conserving femoral components are increasingly used in total hip arthroplasty (THA). They are expected to allow tissue-conserving implantation and to render future revision surgery more straightforward but the long-term data on such components is limited. One such component is the global tissue-sparing (GTS) stem. Following the model for stepwise introduction of new orthopaedic implants, we evaluated early implant fixation and clinical outcome of this novel short-stem THA and compared it to that of a component with established good long-term clinical outcome.
METHODS
In total, 50 consecutive patients ≤ 70 years old with end-stage symptomatic osteo-arthritis were randomized to receive THA with the GTS stem or the conventional Taperloc stem using the anterior supine intermuscular approach by two experienced hip surgeons in two hospitals in the Netherlands. Primary outcome was implant migration. Patients were followed using routine clinical examination, patient reported outcome using Harris Hip Score (HHS), Hip Disability And Osteoarthritis Outcome Score (HOOS), EuroQol five-dimension questionnaire (EQ5D), and Roentgen Stereophotogrammetric Analysis (RSA) at three, six, 12, and 24 months. This study evaluated the two-year follow-up results.
RESULTS
In addition to the initial migration pattern of distal migration (subsidence, Y-translation) and retroversion (Y-rotation) also exhibited by the Taperloc stem, the GTS stem showed an initial migration pattern of varization (X-translation combined with Z-rotation) and posterior translation (Z-translation). However, all components stabilized aside from one Taperloc stem which became loose secondary to malposition and was later revised. Clinical outcomes and complications were not statistically significantly different with the numbers available.
CONCLUSION
A substantially different and more extensive initial migration pattern was seen for the GTS stem compared to the Taperloc stem. Although implant stabilization was achieved, excellent long-term survival similar to that of the Taperloc stem should not be inferred. Especially in the absence of clinically proven relevant improvement, widespread usage should be postponed until long-term safety has been established. Cite this article: Bone Joint J 2020;102-B(6):699-708.",2020,A substantially different and more extensive initial migration pattern was seen for the GTS stem compared to the Taperloc stem.,"['50 consecutive patients ≤ 70 years old with end-stage symptomatic osteo-arthritis', 'total hip arthroplasty (THA']","['THA with the GTS stem or the conventional Taperloc stem using the anterior supine intermuscular approach by two experienced hip surgeons', 'bone-conserving femoral components', 'Fixation of the short global tissue-sparing hip stem']","['excellent long-term survival', 'Harris Hip Score (HHS), Hip Disability And Osteoarthritis Outcome Score (HOOS), EuroQol five-dimension questionnaire (EQ5D), and Roentgen Stereophotogrammetric Analysis (RSA', 'implant migration', 'extensive initial migration pattern']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449434', 'cui_str': 'Femoral component'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}, {'cui': 'C0560562', 'cui_str': 'roentgen'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",50.0,0.0492984,A substantially different and more extensive initial migration pattern was seen for the GTS stem compared to the Taperloc stem.,"[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Nieuwenhuijse', 'Affiliation': 'Department of Orthopaedic Surgery, Haaglanden Medical Center, The Hague, the Netherlands.'}, {'ForeName': 'Stephan B W', 'Initials': 'SBW', 'LastName': 'Vehmeijer', 'Affiliation': 'Department of Orthopaedic Surgery, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Nina M C', 'Initials': 'NMC', 'LastName': 'Mathijsen', 'Affiliation': 'Department of Orthopaedic Surgery, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Stefan B', 'Initials': 'SB', 'LastName': 'Keizer', 'Affiliation': 'Department of Orthopaedic Surgery, Haaglanden Medical Center, The Hague, the Netherlands.'}]",The bone & joint journal,['10.1302/0301-620X.102B6.BJJ-2019-1026.R2']
3229,32475261,Memory improvement in multiple sclerosis after an extensive cognitive rehabilitation program in groups with a multicenter double-blind randomized trial.,"OBJECTIVE
The aim of this study is to determine the effectiveness of an extended cognitive rehabilitation program in group's sessions in multiple sclerosis.
DESIGN
Double-blind multicenter randomized trial.
PARTICIPANTS
People with multiple sclerosis of 18 to 60 years, Expanded Disability Status Scale ⩽6.0, mild to moderate cognitive impairment.
INTERVENTIONS
They were randomized into cognitive rehabilitation program (ProCog-SEP) or in a placebo program. ProCog-SEP comprises 13 group's sessions over 6 months and includes psychoeducational advices and cognitive exercises. Placebo program included non-cognitive exercises. No strategy and no cognitive advice were provided.
MAIN MEASURES
The primary endpoint was the percentage of verbal memory learning measured by the Selective Reminding Test. A comprehensive neuropsychological assessment is carried out before and after interventions by a neuropsychologist blinded to intervention. Effectiveness of the ProCog-SEP versus Placebo has been verified using linear regression models.
RESULTS
In total, 128 participants were randomized and 110 were included in the study after planning session in groups; 101 completed this trial (77.2% females); mean age: 46.1 years (±9.6); disease duration: 11.8 years (±7.5). ProCog-SEP was more effective in increasing in learning index (9.21 (95% confidence interval (CI): 1.43, 16.99); p = 0.02) and in working memory on manipulation (0.63 (95% CI: 0.17, 1.09); p = 0.01), and updating capacities (-1.1 (95% CI: -2.13, -0.06); p = 0.04). No difference was observed for other neuropsychological outcomes. Regarding quality of life outcomes, no change was observed between the two groups.
CONCLUSION
These findings suggest that ProCog-SEP could improve verbal learning abilities and working memory in people with multiple sclerosis. These improvements were observed with 13 group sessions over 6 months.",2020,"ProCog-SEP was more effective in increasing in learning index (9.21 (95% confidence interval (CI): 1.43, 16.99); ","['people with multiple sclerosis', '128 participants were randomized and 110 were included in the study after planning session in groups; 101 completed this trial (77.2% females); mean age: 46.1\u2009years (±9.6); disease duration: 11.8\u2009years (±7.5', 'People with multiple sclerosis of 18 to 60\u2009years, Expanded Disability Status Scale ⩽6.0, mild to moderate cognitive impairment']","['Placebo', 'psychoeducational advices and cognitive exercises', 'cognitive rehabilitation program (ProCog-SEP', 'extensive cognitive rehabilitation program', 'ProCog-SEP versus Placebo', 'extended cognitive rehabilitation program', 'ProCog-SEP', 'placebo program']","['percentage of verbal memory learning', 'working memory on manipulation', 'updating capacities', 'verbal learning abilities and working memory', 'non-cognitive exercises', 'quality of life outcomes', 'learning index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",128.0,0.225021,"ProCog-SEP was more effective in increasing in learning index (9.21 (95% confidence interval (CI): 1.43, 16.99); ","[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Brissart', 'Affiliation': 'UMR 7039, Université de Lorraine, CNRS, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Abdou Y', 'Initials': 'AY', 'LastName': 'Omorou', 'Affiliation': 'EA 4360 Apemac, Université Lorraine, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Forthoffer', 'Affiliation': 'Department of Neurology, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Berger', 'Affiliation': 'Department of Neurology, Besançon University Hospital, Besançon, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Moreau', 'Affiliation': 'Department of Neurology, CHU de Dijon, Dijon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'De Seze', 'Affiliation': 'Department of Neurology and Clinical Investigation Center, CHU de Strasbourg, INSERM 1434, Strasbourg, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Morele', 'Affiliation': 'LORSEP (Multiple Sclerosis Network), Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debouverie', 'Affiliation': 'Department of Neurology, Nancy University Hospital, Nancy, France.'}]",Clinical rehabilitation,['10.1177/0269215520920333']
3230,32475262,Comparison between embryos transferred with self-spent and fresh medium on reproductive outcomes: a prospective randomized trial.,"As the final and critical step in in vitro fertilization (IVF), embryo transfer has always received much attention and deserves continuous optimization. In the present study, to explore the role of autocrine factors in embryo self-spent culture media, we prospectively compared embryo transfer with self-spent culture medium and fresh medium on clinical pregnancy outcomes. A total of 318 fresh IVF/intracytoplasmic sperm injection (ICSI) cycles were randomly allocated into two subgroups based on their transfer media (using a self-spent culture medium or new pre-equilibrated culture media), and the clinical outcomes were compared between groups. The implantation rates, clinical pregnancy rates and live birth rates for transfer using self-spent medium instead of new pre-equilibrated culture medium were slightly improved without statistical significance. Interestingly, however, biochemical pregnancy rate was found to be significantly decreased after transfer using self-spent medium for Day 3 embryos compared with new pre-equilibrated culture media. In short, embryo transfer with self-spent culture medium has shown some advantages, and large sample size studies are still needed to confirm these observations.
ABBREVIATIONS
ART: assisted reproductive technologies; ICSI: intracytoplasmic sperm injection; IVF: in vitro fertilization; ET: embryo transfer.",2020,"Interestingly, however, biochemical pregnancy rate was found to be significantly decreased after transfer using self-spent medium for Day 3 embryos compared with new pre-equilibrated culture media.",['A total of 318 fresh IVF/intracytoplasmic sperm injection (ICSI) cycles'],"['embryos transferred with self-spent and fresh medium', 'embryo transfer with self-spent culture medium and fresh medium']","['implantation rates, clinical pregnancy rates and live birth rates for transfer using self-spent medium instead of new pre-equilibrated culture medium', 'reproductive outcomes', 'biochemical pregnancy rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0010454', 'cui_str': 'Culture medium'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0010454', 'cui_str': 'Culture medium'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}]",318.0,0.0386931,"Interestingly, however, biochemical pregnancy rate was found to be significantly decreased after transfer using self-spent medium for Day 3 embryos compared with new pre-equilibrated culture media.","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Reproductive Medicine Department, Jinan Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences , Jinan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Reproductive Medicine Center, Gansu Provincial Maternity and Child-Care Hospital , Lanzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Reproductive Medicine Department, Jinan Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences , Jinan, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Reproductive Medicine Department, Jinan Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences , Jinan, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Reproductive Medicine Center, Gansu Provincial Maternity and Child-Care Hospital , Lanzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of Life Science, Shandong University , Jinan, China.'}, {'ForeName': 'Yunshan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cheeloo College of Medicine, Shandong University , Jinan, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Reproductive Medicine Department, Jinan Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences , Jinan, China.'}]",Systems biology in reproductive medicine,['10.1080/19396368.2020.1764132']
3231,32484444,A Social Media-Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial.,"BACKGROUND
Youth living with HIV (YLHIV) enrolled in HIV treatment experience higher loss to follow-up, suboptimal treatment adherence, and greater HIV-related mortality compared with younger children or adults. Despite poorer health outcomes, few interventions target youth specifically. Expanding access to mobile phone technology, in low- and middle-income countries (LMICs) in particular, has increased interest in using this technology to improve health outcomes. mHealth interventions may present innovative opportunities to improve adherence and retention among YLHIV in LMICs.
OBJECTIVE
This study aimed to test the effectiveness of a structured support group intervention, Social Media to promote Adherence and Retention in Treatment (SMART) Connections, delivered through a social media platform, on HIV treatment retention among YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support.
METHODS
We conducted a parallel, unblinded randomized controlled trial. YLHIV enrolled in HIV treatment for less than 12 months were randomized in a 1:1 ratio to receive SMART Connections (intervention) or standard of care alone (control). We collected data at baseline and endline through structured interviews and medical record extraction. We also conducted in-depth interviews with subsets of intervention group participants. The primary outcome was retention in HIV treatment. We conducted a time-to-event analysis examining time retained in treatment from study enrollment to the date the participant was no longer classified as active-on-treatment.
RESULTS
A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172). Our primary analysis included data from 324 participants at endline. The probability of being retained in treatment did not differ significantly between the 2 study arms during the study. Retention was high at endline, with 75.7% (112/163) of intervention group participants and 83.4% (126/161) of control group participants active on treatment. HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support. Intervention group participants overwhelmingly reported that the intervention was useful, that they enjoyed taking part, and that they would recommend it to other YLHIV.
CONCLUSIONS
Our findings of improved HIV knowledge and high acceptability are encouraging, despite a lack of measurable effect on retention. Retention was greater than anticipated in both groups, likely a result of external efforts that began partway through the study. Qualitative data indicate that the SMART Connections intervention may have contributed to retention, adherence, and social support in ways that were not captured quantitatively. Web-based delivery of support group interventions can permit people to access information and other group members privately, when convenient, and without travel. Such digital health interventions may help fill critical gaps in services available for YLHIV.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03516318; https://clinicaltrials.gov/ct2/show/NCT03516318.",2020,"HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support.","['YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support', 'Youth living with HIV (YLHIV', 'A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172', 'YLHIV enrolled in HIV treatment for less than 12 months', 'Youth Living With HIV in Nigeria (SMART Connections', '324 participants at endline']","['structured support group intervention, Social Media', 'SMART Connections intervention', 'SMART Connections (intervention) or standard of care alone (control']","['Retention', 'probability of being retained', 'ART adherence or social support', 'retention in HIV treatment', 'HIV-related knowledge']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C4517713', 'cui_str': '324'}]","[{'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",349.0,0.189111,"HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dulli', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Ridgeway', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Packer', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Murray', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Tolulope', 'Initials': 'T', 'LastName': 'Mumuni', 'Affiliation': 'Center for Population and Reproductive Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Kate F', 'Initials': 'KF', 'LastName': 'Plourde', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'FHI 360, Durham, NC, United States.'}, {'ForeName': 'Adesola', 'Initials': 'A', 'LastName': 'Olumide', 'Affiliation': 'Center for Population and Reproductive Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Oladosu', 'Initials': 'O', 'LastName': 'Ojengbede', 'Affiliation': 'Center for Population and Reproductive Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'McCarraher', 'Affiliation': 'FHI 360, Durham, NC, United States.'}]",Journal of medical Internet research,['10.2196/18343']
3232,32484446,Promoting Antenatal Care Attendance Through a Text Messaging Intervention in Samoa: Quasi-Experimental Study.,"BACKGROUND
Antenatal care (ANC) has the potential to improve maternal health, but it remains underutilized and unevenly implemented in many low- and middle-income countries. Increasingly, text messaging programs for pregnant women show evidence that they can improve the utilization of ANC during pregnancy; however, gaps remain regarding how implementation affects outcomes.
OBJECTIVE
This study aimed to assess facilitators and barriers to implementation of an SMS text messaging intervention for pregnant women in Samoa and to assess its impact on ANC attendance.
METHODS
This study took place in Upolu, Samoa, from March to August 2014 and employed a quasi-experimental design. Half (n=3) of the public antenatal clinics on the island offered adult pregnant women the SMS text messaging intervention, with 552 women registering for the messages. At the comparison clinics (n=3), 255 women registered and received usual care. The intervention consisted of unidirectional text messages containing health tips and appointment reminders. The outcome of interest was the number of attended antenatal visits. Implementation data were also collected through a survey of the participating midwives (n=7) and implementation notes. Data analysis included a comparison of women's baseline characteristics between the two groups, followed by the use of negative binomial regressions to test for associations between participation in the intervention and increased ANC attendance, controlling for individual characteristics and accounting for the clustering of women within clinics.
RESULTS
The comparison of ANC attendance rates found that women receiving the SMS text messaging intervention attended 15% fewer ANC visits than the comparison group (P=.004), controlling for individual characteristics and clustering. Data analysis of the implementation process suggests that barriers to successful implementation include women registering very late in pregnancy, sharing their phone with others, and inconsistent explanation of the intervention to women.
CONCLUSIONS
These results suggest that unidirectional text messages do not encourage, and might even discourage, ANC attendance in Samoa. Interpreted with other evidence in the literature, these results suggest that SMS text messaging interventions are more effective when they facilitate better communication between patients and health workers. This study is an important contribution to our understanding of when SMS text messaging interventions are and are not effective in improving maternal health care utilization.",2020,"The comparison of ANC attendance rates found that women receiving the SMS text messaging intervention attended 15% fewer ANC visits than the comparison group (P=.004), controlling for individual characteristics and clustering.","['pregnant women in Samoa', 'Half (n=3) of the public antenatal clinics on the island offered adult pregnant women the', '255 women registered and received usual care', '552 women registering for the messages', 'pregnant women']","['SMS text messaging intervention', 'unidirectional text messages containing health tips and appointment reminders', 'SMS text messaging interventions']","['ANC attendance rates', 'number of attended antenatal visits']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242537', 'cui_str': 'Navigator Islands'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]",255.0,0.0661568,"The comparison of ANC attendance rates found that women receiving the SMS text messaging intervention attended 15% fewer ANC visits than the comparison group (P=.004), controlling for individual characteristics and clustering.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Watterson', 'Affiliation': 'School of Public Health, University of California, Berkeley, Berkeley, CA, United States.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Castaneda', 'Affiliation': 'Facebook Research, Menlo Park, CA, United States.'}, {'ForeName': 'Caricia', 'Initials': 'C', 'LastName': 'Catalani', 'Affiliation': 'Design for Health, IDEO, San Francisco, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/15890']
3233,32484448,"Comparing a Social and Communication App, Telephone Intervention, and Usual Care for Diabetes Self-Management: 3-Arm Quasiexperimental Evaluation Study.","BACKGROUND
Many technology-assisted innovations have been used to manage disease. However, most of these innovations are not broadly used by older adults due to their cost. Additionally, disease management through technology-assisted innovations has not been compared with other interventions.
OBJECTIVE
In this study, we tested the employment of a free and widely used social and communication app to help older adults with diabetes manage their distress and glycemic control. We also compared the effectiveness of the app with 2 other methods, namely telephone and conventional health education, and determined which subgroup experiences the most effects within each intervention.
METHODS
Adults aged ≥50 years with type 2 diabetes were recruited from Southern Taiwan (N=231) and were allocated to different 3-month interventions. Informed consent was obtained at the Ministry of Science and Technology and approved by the National Cheng Kung University Hospital Institutional Review Board (No. A-ER-102-425).
RESULTS
Participants in the mobile-based group had significant reductions in hemoglobin A1c compared with the telephone-based and usual care groups (mean changes of -0.4%, 0.1%, and 0.03%, respectively; P=.02). Diabetes-specific distress decreased to a greater extent in the mobile-based group compared to the other 2 groups (mean changes of -5.16, -3.49, and -2.44, respectively, P=.02). Subgroup analyses further revealed that the effects on reducing blood glucose levels in the social and communication app groups were especially evident in patients with lower distress scores, and diabetes-related distress was especially evident in participants who were younger than 60 years or had higher educational levels.
CONCLUSIONS
The findings of this study inform more flexible use of social and communication apps with in-person diabetes education and counselling.",2020,"RESULTS
Participants in the mobile-based group had significant reductions in hemoglobin A1c compared with the telephone-based and usual care groups (mean changes of -0.4%, 0.1%, and 0.03%, respectively; P=.02).","['Adults aged ≥50 years with type 2 diabetes were recruited from Southern Taiwan (N=231', 'older adults with diabetes manage their distress and glycemic control']","['Social and Communication App, Telephone Intervention, and Usual Care']","['blood glucose levels', 'hemoglobin A1c', 'diabetes-related distress', 'Diabetes-specific distress']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0432114,"RESULTS
Participants in the mobile-based group had significant reductions in hemoglobin A1c compared with the telephone-based and usual care groups (mean changes of -0.4%, 0.1%, and 0.03%, respectively; P=.02).","[{'ForeName': 'Ching-Ju', 'Initials': 'CJ', 'LastName': 'Chiu', 'Affiliation': 'Institute of Gerontology, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yung-Chen', 'Initials': 'YC', 'LastName': 'Yu', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Ye-Fong', 'Initials': 'YF', 'LastName': 'Du', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Yi-Ching', 'Initials': 'YC', 'LastName': 'Yang', 'Affiliation': 'Department of Family Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Jou-Yin', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Public Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Wong', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chanuantong', 'Initials': 'C', 'LastName': 'Tanasugarn', 'Affiliation': 'Faculty of Public Health, Mahidol University, Bangkok, Thailand.'}]",JMIR mHealth and uHealth,['10.2196/14024']
3234,32484533,Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial.,"Importance
Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates.
Objective
To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality.
Design, Setting, and Participants
Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019.
Interventions
Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743).
Main Outcomes and Measures
The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality.
Results
Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important).
Conclusions and Relevance
Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.",2020,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","['1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n\u2009=\u2009735 in both randomization groups) and were included in the analysis', 'women with 1 previous cesarean delivery', 'A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019']","[""tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool"", 'patient-centered decision support tool', 'Patient-Centered Decision Support Tool']","['labor; vaginal birth', 'labor rates', 'cesarean delivery rates', '5 decision quality measures (eg, mean decisional conflict scores', 'Rates of Trial of Labor', 'rate of trial of labor', 'rates of trial of labor and vaginal birth', 'vaginal birth rates', 'maternal and neonatal outcomes and decision quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0005608', 'cui_str': 'Birth Rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.215832,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Anjali J', 'Initials': 'AJ', 'LastName': 'Kaimal', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Cinthia', 'Initials': 'C', 'LastName': 'Blat', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Mari-Paule', 'Initials': 'MP', 'LastName': 'Thiet', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Yamilee', 'Initials': 'Y', 'LastName': 'Bermingham', 'Affiliation': 'Marin Community Clinic, San Rafael, California.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Altshuler', 'Affiliation': 'California Pacific Medical Center, San Francisco.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bryant', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Feinberg School of Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}]",JAMA,['10.1001/jama.2020.5952']
3235,32484630,A Randomized Trial of Broad Area ALA-PDT for Field Cancerization Mitigation in High-Risk Patients.,"BACKGROUND
The relationship between actinic keratoses (AKs) and nonmelanoma skin cancers (NMSCs) is well established. Patients with field cancerization are at high risk of developing new lesions. A treatment to interrupt new lesion formation or progression is required.
OBJECTIVE
To evaluate occurrence of AKs in high-risk patients after field aminolevulinic acid–photodynamic therapy (ALA–PDT).
METHODS
In this randomized, parallel-group, evaluator-blinded, 52-week study, patients with 4–15 facial AKs (N = 166) were random-ized (ALA 2x vs ALA 3x vs vehicle [VEH]-pooled [VEH 2x+VEH 3x], 1:1:1) to receive 2 or 3 PDT treatments (1-hour incubation) following cryotherapy at screening.
RESULTS
More ALA-treated patients than VEH-treated patients had no AKs at week 52 (ALA 2x, 36.0%, P=0.0102; ALA 3x, 37.5%, P=0.0089; VEH, 18.9%). Week 52 lesion recurrence rates were 7.7% (P=0.0004) and 6.1% (P<0.0001) for ALA 2x and ALA 3x, respec-tively, versus 15.5% for VEH. Therapy was well tolerated; no patient requested early termination of light treatment. ALA 3x reduced NMSC development versus VEH (5 vs 12 lesions, P=0.0014).
CONCLUSION
2 or 3 ALA–PDT treatments with 1-hour incubation can significantly reduce occurrence of AKs after 1 year in patients at high risk of NMSC versus VEH–PDT (NCT02239679). J Drugs Dermatol. 2020;19(5):452-458. doi:10.36849/JDD.2020.4930.",2020,"ALA 3x reduced NMSC development versus VEH (5 vs 12 lesions, P=0.0014).
","['High-Risk Patients', 'patients with 4–15 facial AKs (N = 166) were', 'high-risk patients after field aminolevulinic acid–photodynamic therapy (ALA–PDT', 'actinic keratoses (AKs) and nonmelanoma skin cancers (NMSCs']","['random-ized (ALA 2x vs ALA 3x vs vehicle [VEH]-pooled [VEH 2x+VEH 3x], 1:1:1) to receive 2 or 3 PDT treatments (1-hour incubation) following cryotherapy at screening', 'ALA-PDT']","['occurrence of AKs', 'tolerated', 'lesion recurrence rates']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",166.0,0.14197,"ALA 3x reduced NMSC development versus VEH (5 vs 12 lesions, P=0.0014).
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Piacquadio', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Houlihan', 'Affiliation': ''}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Ferdon', 'Affiliation': ''}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Berg', 'Affiliation': ''}, {'ForeName': 'Stuart L', 'Initials': 'SL', 'LastName': 'Marcus', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,[]
3236,32479140,Cost per responder for guselkumab versus secukinumab in the United States based on a head-to-head trial of moderate to severe plaque psoriasis .,"Aims: To estimate cost per response (CPR) in the United States and number-needed-to-treat (NNT) among subjects receiving guselkumab or secukinumab for moderate to severe plaque psoriasis. Materials and methods: Results from ECLIPSE, a double-blind, head-to-head, 48-week study of guselkumab compared with secukinumab were used to estimate 48-week, annual induction, and maintenance year CPRs for Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responses for all patients and for PASI 90 response in patients according to previous systemic treatment. Results: Week 48 PASI 90 response rates were 84.5% for guselkumab and 70.0% for secukinumab. The CPR for PASI 90 response at 48 weeks was $89,960 for guselkumab versus $110,977 for secukinumab, and for the maintenance year it was $77,109 for guselkumab versus $88,781 for secukinumab. The NNT for a PASI 90 response was 1.18 for guselkumab and 1.43 for secukinumab. CPR and NNT values were also lower for guselkumab than for secukinumab, for PASI 75 and PASI 100 for the three time periods, and for PASI 90 at 48-weeks, regardless of previous systemic treatment. Conclusions: Results from a head-to-head study showed that, compared with secukinumab, guselkumab had lower NNTs and CPRs for PASI 75, PASI 90, and PASI 100 responses.",2020,"CPR and NNT values were also lower for guselkumab than for secukinumab, for PASI 75 and PASI 100 for the three time periods, and for PASI 90 at 48-weeks, regardless of previous systemic treatment.",['subjects receiving guselkumab or secukinumab for moderate to severe plaque psoriasis'],['guselkumab versus secukinumab'],"['CPR and NNT values', 'PASI 90 response rates', 'cost per response (CPR']","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.156471,"CPR and NNT values were also lower for guselkumab than for secukinumab, for PASI 75 and PASI 100 for the three time periods, and for PASI 90 at 48-weeks, regardless of previous systemic treatment.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Teeple', 'Affiliation': 'Real World Value & Evidence, Janssen Scientific Affairs LLC, Horsham, PA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Fitzgerald', 'Affiliation': 'Real World Value & Evidence, Janssen Scientific Affairs LLC, Horsham, PA, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1770172']
3237,32479160,Public Service Announcements to Change Attitudes about Youth Suicide: A Randomized Controlled Trial.,"Background: Youth suicide is a major public health concern worldwide. Public service announcements (PSAs) may have a role in suicide prevention, as part of broader suicide prevention campaigns. Method: We conducted a double-blind four arm randomized controlled trial in which 18 to 24 year olds were allocated to watch one of three suicide prevention PSAs intervention PSAs or a control PSA. Participants provided data prior to viewing their allocated PSA and again four weeks after viewing it. Our primary outcome was a change in participants' attitudes toward the preventability of suicide, and analysis was conducted on an intention-to-treat basis. Results: A total of 349 participants were randomized to one of four groups and 266 participants provided pre and post viewing data. Across the four groups, no significant change was observed in our primary outcome: attitudes toward the preventability of suicide ( p = .455). There were also no differences between groups on secondary outcomes, namely other attitudes toward suicide (permissiveness, incomprehensibility, avoidance and loneliness), risk taking behavior, levels of distress, suicidal ideation, and likelihood of help-seeking and actual help-seeking. Conclusion: Our study has highlighted that attitudes and help-seeking intentions in young adults are difficult to change with low intensity one-off exposure to PSA messages. Further research is required to understand the factors that contribute to safe and effective messaging about suicide prevention.",2020,"There were also no differences between groups on secondary outcomes, namely other attitudes toward suicide (permissiveness, incomprehensibility, avoidance and loneliness), risk taking behavior, levels of distress, suicidal ideation, and likelihood of help-seeking and actual help-seeking.","['18 to 24\u2009year olds', 'Public Service Announcements to Change Attitudes about Youth Suicide', 'young adults', '349 participants were randomized to one of four groups and 266 participants provided pre and post viewing data']","['Public service announcements (PSAs', 'suicide prevention PSAs intervention PSAs or a control PSA']","['attitudes toward suicide (permissiveness, incomprehensibility, avoidance and loneliness), risk taking behavior, levels of distress, suicidal ideation, and likelihood of help-seeking and actual help-seeking', 'preventability of suicide', ""participants' attitudes toward the preventability of suicide""]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0687688', 'cui_str': 'Public Service Announcements'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0687688', 'cui_str': 'Public Service Announcements'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]",349.0,0.24792,"There were also no differences between groups on secondary outcomes, namely other attitudes toward suicide (permissiveness, incomprehensibility, avoidance and loneliness), risk taking behavior, levels of distress, suicidal ideation, and likelihood of help-seeking and actual help-seeking.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ftanou', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Machlin', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Spittal', 'Affiliation': ''}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Nicholas', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hocking', 'Affiliation': ''}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Reavley', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Pirkis', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2020.1765929']
3238,32479166,Long-Term Rituximab Use to Maintain Remission of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Trial.,"BACKGROUND
Biannual rituximab infusions over 18 months effectively maintain remission after a ""standard"" remission induction regimen for patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV).
OBJECTIVE
To evaluate the efficacy of prolonged rituximab therapy in preventing AAV relapses in patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who have achieved complete remission after completing an 18-month maintenance regimen.
DESIGN
Randomized controlled trial. (ClinicalTrials.gov: NCT02433522).
SETTING
39 clinical centers in France.
PATIENTS
68 patients with GPA and 29 with MPA who achieved complete remission after the first phase of maintenance therapy.
INTERVENTION
Rituximab or placebo infusion every 6 months for 18 months (4 infusions).
MEASUREMENTS
The primary end point was relapse-free survival at month 28. Relapse was defined as new or reappearing symptoms or worsening disease, with a Birmingham Vasculitis Activity Score greater than 0.
RESULTS
From March 2015 to April 2016, 97 patients (mean age, 63.9 years; 35% women) were randomly assigned, 50 to the rituximab and 47 to the placebo group. Relapse-free survival estimates at month 28 were 96% (95% CI, 91% to 100%) and 74% (CI, 63% to 88%) in the rituximab and placebo groups, respectively, an absolute difference of 22% (CI, 9% to 36%) with a hazard ratio of 7.5 (CI, 1.67 to 33.7) ( P = 0.008). Major relapse-free survival estimates at month 28 were 100% (CI, 93% to 100%) versus 87% (CI, 78% to 97%) ( P = 0.009), respectively. At least 1 serious adverse event developed in 12 patients (24%) in the rituximab group (with 9 infectious serious adverse events occurring among 6 patients [12%]) versus 14 patients (30%) in the placebo group (with 6 infectious serious adverse events developing among 4 patients [9%]). No deaths occurred in either group.
LIMITATION
Potential selection bias based on previous rituximab response and tolerance.
CONCLUSION
Extended therapy with biannual rituximab infusions over 18 months was associated with a lower incidence of AAV relapse compared with standard maintenance therapy.
PRIMARY FUNDING SOURCE
French Ministry of Health and Hoffmann-La Roche.",2020,"Major relapse-free survival estimates at month 28 were 100% (CI, 93% to 100%) versus 87% (CI, 78% to 97%) ( P = 0.009), respectively.","['patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who have achieved complete remission after completing an 18-month maintenance regimen', 'Antineutrophil Cytoplasmic Antibody-Associated Vasculitis', 'From March 2015 to April 2016, 97 patients (mean age, 63.9 years; 35% women', '68 patients with GPA and 29 with MPA who achieved complete remission after the first phase of maintenance therapy', '39 clinical centers in France', 'patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV']","['placebo', 'Rituximab or placebo', 'rituximab', 'rituximab therapy']","['Relapse-free survival estimates', 'AAV relapse', 'Major relapse-free survival estimates', 'deaths', 'Relapse', 'relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0103647', 'cui_str': 'Anti neutrophilic cytoplasm antibody'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4047978', 'cui_str': 'Rituximab therapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",68.0,0.307403,"Major relapse-free survival estimates at month 28 were 100% (CI, 93% to 100%) versus 87% (CI, 78% to 97%) ( P = 0.009), respectively.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Charles', 'Affiliation': 'Cochin Hospital, Paris Descartes University, and Institut Mutualiste Montsouris, Paris, France (P.C.).'}, {'ForeName': 'Élodie', 'Initials': 'É', 'LastName': 'Perrodeau', 'Affiliation': ""Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, Sorbonne Paris Cité INSERM Unité 1153, Paris, France (É.P., P.R.).""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Samson', 'Affiliation': 'Centre Hospitalier Universitaire de Dijon, INSERM, UMR 1098, University of Bourgogne Franche-Comté, FHU INCREASE, Dijon, France (M.S., B.B.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Bonnotte', 'Affiliation': 'Centre Hospitalier Universitaire de Dijon, INSERM, UMR 1098, University of Bourgogne Franche-Comté, FHU INCREASE, Dijon, France (M.S., B.B.).'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Néel', 'Affiliation': 'CRTI UMR 1064, INSERM, Université de Nantes, and Centre Hospitalier Universitaire Nantes, Nantes, France (A.N.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Agard', 'Affiliation': 'Centre Hospitalier Universitaire Nantes, Nantes, France (C.A.).'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Huart', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Toulouse, France (A.H., G.P.).'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Karras', 'Affiliation': 'Hôpital Européen Georges-Pompidou, Université Paris Descartes, Paris, France (A.K.).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lifermann', 'Affiliation': 'Centre Hospitalier de Dax, Dax, France (F.L.).'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Godmer', 'Affiliation': 'Centre Hospitalier Bretagne Atlantique de Vannes, Vannes, France (P.G.).'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Cohen', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hanrotel-Saliou', 'Affiliation': 'Hôpital la Cavale Blanche, Centre Hospitalier Universitaire Brest, Brest, France (C.H.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Martin-Silva', 'Affiliation': 'Centre Hospitalier Universitaire de Caen, Caen, France (N.M.).'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Pugnet', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Toulouse, France (A.H., G.P.).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maurier', 'Affiliation': 'Hôpitaux Privés de Metz, Metz, France (F.M.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Hôpital de Hautepierre, Centre Hospitalier Universitaire de Strasbourg, Strasbourg, France (J.S.).'}, {'ForeName': 'Pierre-Louis', 'Initials': 'PL', 'LastName': 'Carron', 'Affiliation': 'Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France (P.C.).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gobert', 'Affiliation': 'Clinique Rhône Durance, Avignon, France (P.G.).'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Meaux-Ruault', 'Affiliation': 'Centre Hospitalier Universitaire Jean-Minjoz, Besançon, France (N.M.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Le Gallou', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Rennes, France (T.L.).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Vinzio', 'Affiliation': 'Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France (S.V.).'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Viallard', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Pessac, France (J.V.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hachulla', 'Affiliation': 'Centre Hospitalier Universitaire de Lille, Lille, France (E.H.).'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vinter', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Puéchal', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Terrier', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ravaud', 'Affiliation': ""Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, Sorbonne Paris Cité INSERM Unité 1153, Paris, France (É.P., P.R.).""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mouthon', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Guillevin', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}]",Annals of internal medicine,['10.7326/M19-3827']
3239,32479220,Maternal Cash Transfers Led To Increases In Facility Deliveries And Improved Quality Of Delivery Care In Nigeria.,"Ninety-nine percent of global maternal deaths occur in low- and middle-income countries. The high mortality rates are often attributed to a large portion of births occurring outside of formal health care facilities. This has prompted the creation of programs to promote the use of formal delivery care. However, poor-quality care in health facilities in low- and middle-income countries is well documented. It is not clear that shifting births into health facilities in these settings necessarily leads to better-quality care. We present results from a randomized controlled trial in Nigeria that evaluated a conditional cash transfer intervention that paid pregnant women to deliver in a health facility. We found that the intervention led to a 41 percent increase in facility deliveries. We also found improvements in the quality of delivery care (as a result of more births taking place in formal health care settings) and in overall satisfaction with care. We found no evidence of a reduction in preventable complications that led to maternal deaths, though we found some improvements in self-reported health. Our results indicate that promoting facility deliveries can improve the quality of care received, even in settings where formal care quality is poor. However, modest quality improvements might not be sufficient to substantially improve health outcomes.",2020,"We found no evidence of a reduction in preventable complications that led to maternal deaths, though we found some improvements in self-reported health.","['paid pregnant women to deliver in a health facility', 'Facility Deliveries']",['conditional cash transfer intervention'],"['facility deliveries', 'quality of delivery care', 'health outcomes', 'global maternal deaths']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}]",,0.022662,"We found no evidence of a reduction in preventable complications that led to maternal deaths, though we found some improvements in self-reported health.","[{'ForeName': 'Edward N', 'Initials': 'EN', 'LastName': 'Okeke', 'Affiliation': 'Edward N. Okeke (eokeke@rand.org) is a senior policy researcher in the Department of Economics, Sociology, and Statistics, RAND Corporation, in Arlington, Virginia, and a professor of policy analysis in the Pardee RAND Graduate School, in Santa Monica, California.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Wagner', 'Affiliation': 'Zachary Wagner is an associate policy researcher in the Department of Economics, Sociology, and Statistics, RAND Corporation, in Santa Monica, California.'}, {'ForeName': 'Isa S', 'Initials': 'IS', 'LastName': 'Abubakar', 'Affiliation': 'Isa S. Abubakar is a professor of community medicine at Bayero University and Aminu Kano Teaching Hospital, both in Kano, Nigeria.'}]",Health affairs (Project Hope),['10.1377/hlthaff.2019.00893']
3240,32479559,Effects of singing bowl exposure on Karolinska sleepiness scale and pupillographic sleepiness test: A randomised crossover study.,"BACKGROUND
The aim of this study was to investigate the effects on subjective and objective sleepiness of a stay above a large struck singing bowl compared to a relaxation period in a silent singing bowl.
METHODS
Fifty-eight healthy subjects were recruited for the study, 48 participated on two days, one week apart, during the same timeslot. The Karolinska sleepiness scale was used to evaluate current subjective sleepiness, and the relative pupillary unrest index to assess objective sleepiness. In this randomized cross-over study, the intervention consisted of a 20-minute stay in a hammock while the singing bowl, positioned beneath, was struck seven times. The controlled comparator was a 20-minute stay in the same hammock above the singing bowl, but without being struck. After these two interventions subjective and objective sleepiness were re-evaluated.
RESULTS
The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71 (p = 0.460). The median Karolinska sleepiness scale value after relaxation with the struck singing bowl was 3 compared with 4 (p = 0.041) for the silent singing bowl.
DISCUSSION
This study evaluated the influence of a struck singing bowl on sleepiness during daytime. Subjective sleepiness was significantly lower after relaxation above a struck singing bowl. After gender stratification, the difference was still significant in women. Objective sleepiness was not different in both groups. Finally, we can only speculate if women may be more susceptible to subjective improvements in case of sleepiness and show another perception of relaxation in a struck singing bowl compared to men.",2020,The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71,"['Fifty-eight healthy subjects were recruited for the study, 48 participated on two days, one week apart, during the same timeslot']","['singing bowl exposure', 'struck singing bowl']","['Karolinska sleepiness scale', 'mean relative pupillary unrest index values', 'Karolinska sleepiness scale and pupillographic sleepiness test', 'Objective sleepiness', 'Subjective sleepiness', 'median Karolinska sleepiness scale value']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0336949', 'cui_str': 'Bowling'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0858854', 'cui_str': 'Unrest'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",58.0,0.0151798,The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71,"[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bergmann', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Riedinger', 'Affiliation': 'Department of Therapeutic Radiology and Oncology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mitterling', 'Affiliation': 'Department of Neurology 1, Kepler University Hospital, Linz, Austria.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Holzknecht', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Grassmayr', 'Affiliation': 'Bell Foundry Grassmayr, Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Högl', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}]",PloS one,['10.1371/journal.pone.0233982']
3241,32479591,Effect of an integrated care model for pre-frail and frail older people living in community.,"OBJECTIVES
to evaluate the effect of an integrated care model for pre-frail and frail community-dwelling older people.
DESIGN
a quasi-experimental design.
SETTING AND PARTICIPANTS
we enrolled people aged ≥60 years from a community care project. An inclusion criterion was pre-frailty/frailty, as measured by a simple frailty questionnaire (FRAIL) with a score of ≥1.
METHODS
we assigned participants to an intervention group (n = 183) in which they received an integrated intervention (in-depth assessment, personalised care plans and coordinated care) or a control group (n = 270) in which they received a group education session on frailty prevention. The outcomes were changes in frailty, individual domains of frailty ('fatigue', 'resistance', 'ambulation', 'illnesses' and 'loss of weight') and health services utilisation over 12 months. Assessments were conducted at baseline and at the 12-month follow-up.
RESULTS
the mean age of the participants (n = 453) at baseline was 76.1 ± 7.5 years, and 363 (80.1%) were women. At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033). In addition, 22.4% of the intervention and 13.7% of the control participants had reverted from pre-frail/frail to robust status, with the difference reaching significance when the intervention was compared with the control group (odds ratio [OR] 1.6, 95% confidence interval [CI] 1.0-2.4) after adjustments for age, sex, living arrangement/marital status and hypercholesterolemia. For individual domains of frailty, the adjusted OR for improved 'resistance' was 1.7 (95% CI 1.0-2.8). However, no effects were found on reducing use of health services.
CONCLUSION
the integrated health and social care model reduced FRAIL scores in a combined population of pre-frail/frail community-dwelling older people attending older people's centres.",2020,"At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033).","['pre-frail and frail community-dwelling older people', 'enrolled people aged ≥60\xa0years from a community care project', ""combined population of pre-frail/frail community-dwelling older people attending older people's centres"", 'the mean age of the participants (n\u2009=\u2009453) at baseline was 76.1\u2009±\u20097.5\xa0years, and 363 (80.1%) were women', 'pre-frail and frail older people living in community']","['integrated care model', 'intervention group (n\u2009=\u2009183) in which they received an integrated intervention (in-depth assessment, personalised care plans and coordinated care) or a control group (n\u2009=\u2009270) in which they received a group education session on frailty prevention']","['FRAIL scores', ""changes in frailty, individual domains of frailty ('fatigue', 'resistance', 'ambulation', 'illnesses' and 'loss of weight') and health services utilisation""]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",,0.0395423,"At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033).","[{'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Tong', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}]",Age and ageing,['10.1093/ageing/afaa087']
3242,32479641,Secukinumab shows high and sustained efficacy in nail psoriasis: 2.5-year results from the randomized placebo-controlled TRANSFIGURE study.,"BACKGROUND
Secukinumab, a fully human monoclonal antibody that selectively neutralises interleukin-17A, a cornerstone cytokine in psoriasis, has shown long-lasting efficacy and safety in the complete spectrum of psoriasis manifestations.
OBJECTIVE
To report the long-term (2.5-year) efficacy and safety of secukinumab in nail psoriasis.
METHODS
TRANSFIGURE, a double-blind, randomised, placebo-controlled, parallel-group, multicentre Phase 3b study in 198 patients, investigated secukinumab 150 and 300 mg in moderate to severe nail psoriasis patients.
RESULTS
At Week 16, the primary endpoint NAil Psoriasis Severity Index (NAPSI) was met, demonstrating superiority of secukinumab to placebo. The effect was sustained over 2.5 years with a large benefit on nail clearance with mean NAPSI improvement of -73.3% and -63.6% with secukinumab 300 and 150 mg, respectively. At 2.5 years, secukinumab demonstrated sustained clinically significant reductions in total mean Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) QoL scores by -52.4% and -18.1%, and 70.2% and 70.9% of patients achieved a weighted NAPPA-PBI (Patient Benefit Index) global score of ≥2 with secukinumab 300 and 150 mg, respectively. Patients showed considerable improvements in Euro-QoL 5-Dimension Health Status Questionnaire at 2.5 years, reporting decreased pain and discomfort. No new safety findings were observed.
CONCLUSIONS
Secukinumab demonstrated strong and clinically meaningful efficacy for up to 2.5 years in nail psoriasis, with significant sustained QoL improvements and a favourable safety profile.",2020,"Patients showed considerable improvements in Euro-QoL 5-Dimension Health Status Questionnaire at 2.5 years, reporting decreased pain and discomfort.","['nail psoriasis', '198 patients, investigated secukinumab 150 and 300 mg in moderate to severe nail psoriasis patients']","['Secukinumab', 'secukinumab', 'placebo']","['NAil Psoriasis Severity Index (NAPSI', 'weighted NAPPA-PBI', 'Euro-QoL 5-Dimension Health Status Questionnaire', 'total mean Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) QoL scores', 'nail clearance with mean NAPSI improvement', 'pain and discomfort']","[{'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",198.0,0.366335,"Patients showed considerable improvements in Euro-QoL 5-Dimension Health Status Questionnaire at 2.5 years, reporting decreased pain and discomfort.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sullivan', 'Affiliation': 'Sutherland Hospital, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Arenberger', 'Affiliation': 'Department of Dermatovenereology, Charles University, Third Faculty of Medicine, Prague, Czech Republic.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jazayeri', 'Affiliation': 'Alliance Dermatology and MOHS Center, Phoenix, USA.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Universität Hamburg, Hamburg, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': 'Department of Dermatology, University of Alabama, Birmingham, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'You', 'Affiliation': 'China Novartis Institutes for BioMedical Research, Shanghai, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Regnault', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Frueh', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",The British journal of dermatology,['10.1111/bjd.19262']
3243,32479645,Targeting fear of recurrence: The advantages of assessing psychosocial attributes and psychological dispositions.,We found the randomized controlled trial of a brief psychological intervention targeting fear of recurrence of melanoma patients by Dieng et al. very interesting. The intervention has been shown to be effective and its implementation in the routine care of melanoma patients seems appropriate. In this regard we have developed some considerations we would like to submit to authors and readers.,2020,The intervention has been shown to be effective and its implementation in the routine care of melanoma patients seems appropriate.,[],['psychological intervention'],[],[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.03361,The intervention has been shown to be effective and its implementation in the routine care of melanoma patients seems appropriate.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miniotti', 'Affiliation': 'Rita Levi Montalcini, Department of Neuroscience, Psycho-Oncology Unit, University of Turin, Metropolitan City, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ribero', 'Affiliation': 'Department of Medical Sciences, Dermatology Clinic, University of Turin, Metropolitan City, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Leombruni', 'Affiliation': 'Rita Levi Montalcini, Department of Neuroscience, Psycho-Oncology Unit, University of Turin, Metropolitan City, Italy.'}]",The British journal of dermatology,['10.1111/bjd.19261']
3244,32479701,Vitamin D and stress urinary incontinence in pregnancy: a cross-sectional study.,"OBJECTIVE
To assess the association between levels of vitamin D and urinary incontinence (UI) in pregnancy.
DESIGN
A cross-sectional study. Secondary analysis of a randomised controlled trial. Setting Two university hospitals in Norway. Population 851 healthy, pregnant women >18 years in gestational week 18-22 with a singleton live fetus.
METHODS
Data on UI were collected from a questionnaire at inclusion and serum analysis of 25-hydroxy vitamin D (25(OH)D) was performed. Univariable and multivariable logistic regression analyses were applied to study associations between exposure and outcomes. Main Outcome Measures Prevalence of self-reported UI, stress (SUI) and urge (UUI) or mixed UI.
RESULTS
In total 230/851 (27%) of the participants were vitamin D insufficient (25(OH)D <50nmol/L) and 42% reported to have any UI. Women with 25(OH)D <50nmol/L were more likely to report any UI (p=0.03) and SUI (p<0.01) compared to women with 25(OH)D ≥50nmol/L. In a univariable logistic regression analysis, serum levels of 25(OH)D <50nmol/L was associated with increased risk of any UI (Odds Ratio, OR 1.5 with 95% Confidence interval CI (1.0, 2.1)), SUI only (OR 1.7 (1.2, 2.4)), but not mixed UI or UUI only (OR 0.8 (0.5,1.5)). In a multivariable logistic regression model, serum levels of 25(OH)D <50nmol/L was associated with a higher risk of experiencing SUI only (OR 1.5 (1.1,2.2)).
CONCLUSIONS
Serum 25(OH)D <50nmol/L was associated with increased risk of any UI and SUI in particular.",2020,<50nmol/L were more likely to report any UI (p=0.03) and SUI (p<0.01) compared to women with 25(OH)D ≥50nmol/L.,"['Population 851 healthy, pregnant women >18 years in gestational week 18-22 with a singleton live fetus', 'Data on UI were collected from a questionnaire at inclusion and serum analysis of 25-hydroxy vitamin D (25(OH)D) was performed', 'Women with 25(OH)D', 'pregnancy', 'Setting Two university hospitals in Norway']",['Vitamin D'],"['vitamin D and urinary incontinence (UI', 'Prevalence of self-reported UI, stress (SUI) and urge (UUI) or mixed UI', 'risk of any UI and SUI']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",851.0,0.0672972,<50nmol/L were more likely to report any UI (p=0.03) and SUI (p<0.01) compared to women with 25(OH)D ≥50nmol/L.,"[{'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Nilssen Stafne', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), P.O. Box 8905, 7491, Trondheim, Norway.'}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Mørkved', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), P.O. Box 8905, 7491, Trondheim, Norway.'}, {'ForeName': 'Miriam K', 'Initials': 'MK', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), P.O. Box 8905, 7491, Trondheim, Norway.'}, {'ForeName': 'Unni', 'Initials': 'U', 'LastName': 'Syversen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), P.O. Box 8905, 7491, Trondheim, Norway.'}, {'ForeName': 'Astrid Kamilla', 'Initials': 'AK', 'LastName': 'Stunes', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), P.O. Box 8905, 7491, Trondheim, Norway.'}, {'ForeName': 'Kjell Åsmund', 'Initials': 'KÅ', 'LastName': 'Salvesen', 'Affiliation': 'Department of Obstetrics and Gynecology, St. Olavs Hospital, Trondheim University Hospital, P.O. Box 3250 Sluppen, 7006, Trondheim, Norway.'}, {'ForeName': 'Hege Hølmo', 'Initials': 'HH', 'LastName': 'Johannessen', 'Affiliation': 'Department for Physical Medicine and Rehabilitation, Østfold Hospital Trust, Sarpsborg, Norway.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16340']
3245,32445440,Remdesivir for the Treatment of Covid-19 - Preliminary Report.,"BACKGROUND
Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious.
METHODS
We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.
RESULTS
A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).
CONCLUSIONS
Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS
Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS
Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764']
3246,32474204,Effect on thromboprophylaxis among hospitalized patients using a system-wide multifaceted quality improvement intervention: Rationale and design for a multicenter cluster randomized clinical trial in China.,"BACKGROUND
Venous thromboembolism (VTE) is a life-threatening disease that can affect each hospitalized patient. But the current in-hospital thromboprophylaxis remains suboptimal and there exists a large gap between clinical practice and guideline-recommended care in China.
METHODS
To facilitate implementation of guideline recommendations, we conduct a multicenter, adjudicator-blinded, cluster-randomized clinical trial, aiming to assess the effectiveness of a system-wide multifaceted quality improvement (QI) strategy on VTE prophylaxis improvement and thromboembolism reduction in clinical setting. Hospitals are randomized into intervention or control group. In intervention group, hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education. In control, hospitals receive the concept of recommended prophylaxis alone without QI. Thromboprophylaxis will be at the discretion of hospitals and conducted as usual. With a final sample size of 5760 hospitalized patients in 32 hospitals on mainland China, this trial will examine the effect of QI on improvement in thromboprophylaxis and patient-centered outcomes. This is an open-label trial that patients and healthcare professionals will know group allocation after enrollment, but endpoint adjudicators and statisticians will be blinded. RCT# NCT04211181 CONCLUSIONS: The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.",2020,"The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.","['hospitalized patients using a', '5760 hospitalized patients in 32 hospitals on mainland China', 'hospitalized patients in China']","['system-wide multifaceted quality improvement intervention', 'hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education', 'system-wide multifaceted quality improvement (QI) strategy', 'RCT']",[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]",[],5760.0,0.127351,"The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China.","[{'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Kaiyuan', 'Initials': 'K', 'LastName': 'Zhen', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China; Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chaozeng', 'Initials': 'C', 'LastName': 'Si', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiefeng', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Tieshan', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of information management, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Medical Affairs Department of China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Cunbo', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Guangliang', 'Initials': 'G', 'LastName': 'Shan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, School of Basic Medicine, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhenguo', 'Initials': 'Z', 'LastName': 'Zhai', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China. Electronic address: zhaizhenguo2011@126.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Respiratory Diseases, Beijing, China; Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.020']
3247,32474206,"The INVICTUS rheumatic heart disease research program: Rationale, design and baseline characteristics of a randomized trial of rivaroxaban compared to vitamin K antagonists in rheumatic valvular disease and atrial fibrillation.","BACKGROUND
Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need.
METHODS
The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm 2 , left atrial spontaneous echo-contrast or thrombus, or a CHA 2 DS 2 VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD.
CONCLUSION
INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.",2020,The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding.,"['pregnant women with RHD', 'patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm 2 , left atrial spontaneous echo-contrast or thrombus, or a CHA 2 DS 2 VASc score ≥2', 'rheumatic valvular disease and atrial fibrillation', '17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years', 'patients with valvular AF', 'enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America', 'Patients with RHD and AF', 'patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry', '4500 patients comparing']","['rivaroxaban with vitamin K antagonists (VKA', 'vitamin K antagonists', 'VKAs, rivaroxaban or aspirin', 'rivaroxaban', 'VKA']",['composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026269', 'cui_str': 'Mitral valve stenosis'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0264757', 'cui_str': 'Rheumatic disease of heart valve'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517780', 'cui_str': '4500'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",4565.0,0.080112,The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding.,"[{'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Karthikeyan', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India. Electronic address: karthik2010@gmail.com.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mpiko', 'Initials': 'M', 'LastName': 'Ntsekhe', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Benz', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sumathy', 'Initials': 'S', 'LastName': 'Rangarajan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yun', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sanjib Kumar', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'BP Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Fathi', 'Initials': 'F', 'LastName': 'Maklady', 'Affiliation': 'Suez Canal University Hospital, Egypt.'}, {'ForeName': 'Alaa Eldin', 'Initials': 'AE', 'LastName': 'Elghamrawy', 'Affiliation': 'Suez Canal University Hospital, Egypt.'}, {'ForeName': 'Khawar', 'Initials': 'K', 'LastName': 'Kazmi', 'Affiliation': 'Aga Khan University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Tantchou T J', 'Initials': 'TTJ', 'LastName': 'Cabral', 'Affiliation': 'St. Elizabeth Catholic General Hospital, Cameroon.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Dayi', 'Affiliation': 'People Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Changsheng', 'Affiliation': 'People Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Bernard M', 'Initials': 'BM', 'LastName': 'Gitura', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, Sao Paolo, Brazil.'}, {'ForeName': 'Liesl', 'Initials': 'L', 'LastName': 'Zuhlke', 'Affiliation': 'Red Cross War Memorial Childrens Hospital, Cape Town, South Africa.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lwabi', 'Affiliation': 'Uganda Heart Institute, Kampala, Uganda.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Haileamlak', 'Affiliation': 'Jimma University Hospital, Ethiopia.'}, {'ForeName': 'Okechukwu', 'Initials': 'O', 'LastName': 'Ogah', 'Affiliation': 'University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Pilly', 'Initials': 'P', 'LastName': 'Chillo', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paniagua', 'Affiliation': 'Barrio Obrero Hospital Asunción, Paraguay.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'ElSayed', 'Affiliation': 'Alzaeim Alazhari University, Khartoum, Sudan.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dans', 'Affiliation': 'Philippines General Hospital, Manila, Philippines.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Gondwe-Chunda', 'Affiliation': 'Kamuzu Central Hospital, Malawi.'}, {'ForeName': 'Onkabetse Julia', 'Initials': 'OJ', 'LastName': 'Molefe-Baikai', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Jesus A', 'Initials': 'JA', 'LastName': 'Gonzalez-Hermosillo', 'Affiliation': 'Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Albertino', 'Initials': 'A', 'LastName': 'Damasceno', 'Affiliation': 'Maputo Central Hospital, Maputo, Mozambique.'}, {'ForeName': 'Emmanuel R', 'Initials': 'ER', 'LastName': 'Kamanzi', 'Affiliation': 'University Teaching Hospital of Kigali, Rwanda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Musuku', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Kairat', 'Initials': 'K', 'LastName': 'Davletov', 'Affiliation': 'Al-Farabi Kazakh National University, Almaty, Kazakhstan.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Bongani M', 'Initials': 'BM', 'LastName': 'Mayosi', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.03.018']
3248,32474302,Lower levels of high-density lipoprotein cholesterol are associated with increased cardiovascular events in patients with acute coronary syndrome.,"BACKGROUND AND AIMS
This study aimed to elucidate whether high-density lipoprotein cholesterol (HDL-C) at 3-month follow-up for patients receiving contemporary lipid-lowering therapy after acute coronary syndrome (ACS) could predict cardiac events.
METHODS
The HIJ-PROPER study was a multicenter, prospective, randomized trial comparing intensive lipid-lowering therapy (pitavastatin + ezetimibe) and conventional lipid-lowering therapy (pitavastatin monotherapy) after ACS. The entire cohort was divided into three groups according to tertiles of HDL-C levels at 3-month follow-up (Group 1, HDL-C ≤43 mg/dL; Group 2, HDL-C >43, <53.6 mg/dL; Group 3; HDL-C ≥53.6 mg/dL). Baseline characteristics and incidence of the primary endpoint (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina pectoris, or ischemia-driven revascularization) were compared among the three groups.
RESULTS
The primary endpoint event occurred in 34.8%, 30.1%, and 24.6% of patients in Groups 1, 2, and 3, respectively, and its incidence was significantly higher in Group 1 than in Group 3 (hazard ratio [HR], 1.5; 95% confidence interval [CI], 1.19-1.9; p = 0.001). Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02). These trends remained even after adjustment for baseline characteristics and lipid profiles. Multivariate analysis revealed that lower body mass index, prevalence of diabetes mellitus, higher levels of high-sensitivity C reactive protein at baseline, and lower levels of HDL-C at 3-month follow-up were independent predictors of the incidence of primary endpoint.
CONCLUSIONS
Lower levels of HDL-C at 3-month follow-up are independently associated with higher incidence of cardiovascular events in ACS patients receiving contemporary lipid-lowering therapy.",2020,"Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02).","['patients with acute coronary syndrome', 'ACS patients receiving contemporary lipid-lowering therapy', 'patients receiving contemporary lipid-lowering therapy after acute coronary syndrome (ACS']","['intensive lipid-lowering therapy (pitavastatin\xa0+\xa0ezetimibe) and conventional lipid-lowering therapy (pitavastatin monotherapy', 'high-density lipoprotein cholesterol (HDL-C']","['Baseline characteristics and incidence of the primary endpoint (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina pectoris, or ischemia-driven revascularization', 'cardiovascular events', 'lower body mass index, prevalence of diabetes mellitus, higher levels of high-sensitivity C reactive protein at baseline, and lower levels of HDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",,0.0661322,"Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02).","[{'ForeName': 'Mayui', 'Initials': 'M', 'LastName': 'Nakazawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan. Electronic address: arashi.hiroyuki@twmu.ac.jp.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.05.005']
3249,32474427,Development and evaluation of a patient-centred program for low anterior resection syndrome: protocol for a randomized controlled trial.,"INTRODUCTION
Low anterior resection syndrome (LARS) is described as disordered bowel function after rectal resection that leads to a detriment in quality of life, and affects the majority of individuals following restorative proctectomy for rectal cancer. The management of LARS includes personalised troubleshooting and effective self-management behaviours. Thus, affected individuals need to be well informed and appropriately engaged in their own LARS management. This manuscript describes the development of a LARS patient-centred programme (LPCP) and the study protocol for its evaluation in a randomised controlled trial.
METHODS AND ANALYSIS
This will be a multicentre, randomised, assessor-blind, parallel-groups, pragmatic trial evaluating the impact of an LPCP, consisting of an informational booklet, patient diaries and nurse support, on patient-reported outcomes after restorative proctectomy for rectal cancer. The informational booklet was developed by a multidisciplinary LARS team, and was vetted in a focus group and semistructured interviews involving patients, caregivers, and healthcare professionals. The primary outcome will be global quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), at 6 months after surgery. The treatment effect on global QoL will be modelled using generalised estimating equations. Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP.
ETHICS AND DISSEMINATION
The Research Ethics Committee (REC) at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) is the overseeing REC for all Quebec sites. They have granted ethical approval (MP-05-2019-1628) for all Quebec hospitals (Jewish General Hospital, McGill University Health Center, CHU de Quebec) and have granted full authorisation to begin research at the Jewish General Hospital. Patient recruitment will not begin at the other Quebec sites until inter-institutional contracts are finalised and feasibility/authorisation for research is granted by their respective REC. The results of this study will be presented at national and international conferences, and a manuscript with results will be submitted for publication in a high-impact peer-reviewed journal.
TRIAL REGISTRATION NUMBER
NCT03828318; Pre-results.",2020,"Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP.
","['for rectal cancer', 'low anterior resection syndrome']","['restorative proctectomy', 'LARS patient-centred programme (LPCP']","['symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP', 'global quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}]","[{'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.228641,"Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP.
","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Garfinkle', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Carmen G', 'Initials': 'CG', 'LastName': 'Loiselle', 'Affiliation': 'Department of Oncology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Liliana G', 'Initials': 'LG', 'LastName': 'Bordeianou', 'Affiliation': 'Section of Colon and Rectal Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'A Sender', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Morin', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Faria', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Ghitulescu', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Carol-Ann', 'Initials': 'CA', 'LastName': 'Vasilevsky', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sahir R', 'Initials': 'SR', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada maryliseboutros@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-035587']
3250,32474979,Isometric exercises do not provide immediate pain relief in Achilles tendinopathy: A quasi-randomized clinical trial.,"BACKGROUND
Isometric exercises may provide an immediate analgesic effect in patients with lower-limb tendinopathy and have been proposed as initial treatment and for immediate pain relief. Current evidence is conflicting and previous studies were small.
OBJECTIVE
To study whether isometric exercises result in an immediate analgesic effect in patients with chronic midportion Achilles tendinopathy.
METHODS
Patients with clinically diagnosed chronic midportion Achilles tendinopathy were quasi-randomized to one of four arms: isometric calf-muscle exercises (tiptoes), isometric calf-muscle exercises (dorsiflexed ankle position), isotonic calf-muscle exercises, or rest. The primary outcome was pain measured on a visual analogue scale (VAS)-score (0-100) during a functional task (10 unilateral hops) both before and after the intervention. Between-group differences were analyzed using a Generalized Estimation Equations-model.
RESULTS
We included 91 patients. There was no significant reduction in pain on the 10 hop test after performing any of the four interventions: isometric (tiptoes) group 0.2, 95%CI -11.2 to 11.5; isometric (dorsiflexed) group -1.9, 95%CI -13.6 to 9.7; isotonic group 1.4, 95%CI -8.3 to 11.1; and rest group 7.2, 95%CI -2.4 to 16.7. There were also no between-group differences after the intervention.
CONCLUSION
The isometric exercises investigated in this study did not result in immediate analgesic benefit in patients with chronic midportion Achilles tendinopathy. We do not recommend isometric exercises if the aim is providing immediate pain relief. Future research should focus on the use of isometric or isotonic exercise therapy as initial treatment as all exercise protocols used in this study were well tolerated.",2020,"There was no significant reduction in pain on the 10 hop test after performing any of the four interventions: isometric (tiptoes) group 0.2, 95%CI -11.2 to 11.5; isometric (dorsiflexed) group -1.9, 95%CI -13.6 to 9.7; isotonic group 1.4, 95%CI -8.3 to 11.1; and rest group 7.2, 95%CI -2.4 to 16.7.","['patients with chronic midportion Achilles tendinopathy', '91 patients', 'Achilles', 'tendinopathy', 'Patients with clinically diagnosed chronic midportion Achilles tendinopathy', 'patients with lower-limb tendinopathy']","['Isometric exercises', 'isotonic exercise therapy', 'isometric calf-muscle exercises (tiptoes), isometric calf-muscle exercises (dorsiflexed ankle position), isotonic calf-muscle exercises, or rest', 'isometric exercises']","['pain measured on a visual analogue scale (VAS)-score (0-100) during a functional task (10 unilateral hops', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0950959', 'cui_str': 'Dorsiflex'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}]",91.0,0.139609,"There was no significant reduction in pain on the 10 hop test after performing any of the four interventions: isometric (tiptoes) group 0.2, 95%CI -11.2 to 11.5; isometric (dorsiflexed) group -1.9, 95%CI -13.6 to 9.7; isotonic group 1.4, 95%CI -8.3 to 11.1; and rest group 7.2, 95%CI -2.4 to 16.7.","[{'ForeName': 'Arco C', 'Initials': 'AC', 'LastName': 'van', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'der Vlist', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter Lj', 'Initials': 'PL', 'LastName': 'van Veldhoven', 'Affiliation': 'Department of Sports Medicine, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'van Oosterom', 'Affiliation': 'Department of Sports Medicine, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'An Verhaar', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'de Vos', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13728']
3251,32474993,Melatonin In Acute Mania Investigation (MIAMI-UK). A randomised controlled trial of add-on melatonin in bipolar disorder.,"OBJECTIVES
Current options for treating emergent episodes of hypomania and mania in bipolar disorder are limited. Our objective was to compare the effectiveness and safety of add-on melatonin in hypomania or mania over three weeks as a well-tolerated therapy.
METHODS
A randomised, double-blind, parallel-group, three-week comparison of modified release melatonin (n=21) vs placebo (n=20) in adult bipolar patients aged 18-65 years. Permuted block randomisation was used with participants and investigators masked to treatment allocation. Trial registration is ISRCTN28988273 and EUdraCT2008-000281-23. Approved by the South Central National Research Ethics Service (Oxford REC A) ref: 09/H0604/63.
RESULTS
The trial was negative as there was no significant difference between melatonin and placebo on the primary outcome - mean Young Mania Rating Scale (YMRS) score at Day 21: (mean difference (MD) -1.77 ([95%CI:-6.39 to 2.85]; p=0.447). Significantly fewer patients on melatonin scored 10 or more on the Altman Self Rating Mania Scale (ASRM): (odds ratio (OR) 0.164 [95% CI: 0.0260 to 1.0002]; p=0.05). Quick Inventory of Depression Symptomatology Clinician Version-16 (QIDS-C16) scores were not significantly different. (OR 1.77 [95% CI:0.43 to 7.29]; p=0.430). The proportion of patients scoring less than or equal to 5 on the self-report QIDS-SR16 at end-point was greater for the melatonin group (OR 8.35[95% CI:1.04 to 67.23]; p=0.046).
CONCLUSIONS
In this small trial melatonin did not effectively treat emerging hypomania or mania as there was no significant difference on the primary outcome. The sample size limitation and secondary outcomes suggest further investigation of melatonin treatment in mood episodes is indicated.",2020,The trial was negative as there was no significant difference between melatonin and placebo on the primary outcome - mean Young Mania Rating Scale (YMRS) score at Day 21: (mean difference (MD) -1.77 ([95%CI:-6.39 to 2.85]; p=0.447).,"['adult bipolar patients aged 18-65 years', 'bipolar disorder']","['modified release melatonin (n=21) vs placebo', 'Melatonin', 'melatonin and placebo', 'melatonin']","['Altman Self Rating Mania Scale (ASRM', 'primary outcome - mean Young Mania Rating Scale (YMRS) score', 'effectiveness and safety', 'Quick Inventory of Depression Symptomatology Clinician Version-16 (QIDS-C16) scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}]",,0.550988,The trial was negative as there was no significant difference between melatonin and placebo on the primary outcome - mean Young Mania Rating Scale (YMRS) score at Day 21: (mean difference (MD) -1.77 ([95%CI:-6.39 to 2.85]; p=0.447).,"[{'ForeName': 'Digby J', 'Initials': 'DJ', 'LastName': 'Quested', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Gibson', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Sharpley', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Cordey', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Economou', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'De Crescenzo', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Nuffield Dept. of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lawson', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Rendell', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Hasanen', 'Initials': 'H', 'LastName': 'Al-Taiar', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lennox', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Ahmad', 'Affiliation': 'Berkshire NHS Foundation Trust, Prospect Park Hospital, Honey End Lane, Tilehurst, Reading, Berkshire, RG30 4EJ, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Geddes', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, OX3 7JX, United Kingdom.'}]",Bipolar disorders,['10.1111/bdi.12944']
3252,32475048,Effect of High-Intensity Interval Training on Visceral and Liver Fat in Cardiac Rehabilitation: A Randomized Controlled Trial.,"OBJECTIVE
This study aimed to investigate the effect of exercise intensity on visceral adipose tissue (VAT) and liver fat reduction in patients with coronary artery disease (CAD) over 3 months and the maintenance of improvements over 12 months.
METHODS
Forty-two participants with CAD were randomized to three sessions/week of either 4 × 4-minute high-intensity interval training (HIIT) or 40 minutes of usual care moderate-intensity continuous training (MICT) for a 4-week supervised cardiac rehabilitation program, followed by three home-based sessions/week for 11 months. Liver fat (as intrahepatic lipid) and VAT were measured via magnetic resonance techniques. Data are mean change (95% CI).
RESULTS
HIIT and MICT significantly reduced VAT over 3 months (-350 [-548 to -153] cm 3 vs. -456 [-634 to -278] cm 3 ; time × group effect: P = 0.421), with further improvement over 12 months (-545 [-818 to -271] cm 3 vs. -521 [-784 to -258] cm 3 ; time × group effect: P = 0.577) and no differences between groups. Both groups improved liver fat over 3 months, with HIIT tending to show greater reduction than MICT (-2.8% [-4.0% to -1.6%] vs. -1.4% [-2.4% to -0.4%]; time × group effect: P = 0.077). After 12 months, improvements were maintained to a similar degree. Higher exercise intensity predicted liver fat reduction (β = -0.3 [-0.7 to 0.0]; P = 0.042).
CONCLUSIONS
HIIT and MICT reduced VAT over 3 and 12 months. For liver fat, HIIT tended to provide a slightly greater reduction compared with MICT. These findings support HIIT as a beneficial adjunct or alternative to MICT for reducing visceral and liver fat in patients with CAD.",2020,"RESULTS
HIIT and MICT significantly reduced VAT over 3 months (-350 [-548 to -153]","['Forty-two participants with CAD', 'Cardiac Rehabilitation', 'patients with CAD', 'patients with coronary artery disease (CAD']","['exercise intensity', 'High-Intensity Interval Training', '4\u2009×\u20094-minute high-intensity interval training (HIIT) or 40 minutes of usual care moderate-intensity continuous training (MICT']","['VAT', 'Liver fat (as intrahepatic lipid) and VAT', 'liver fat', 'visceral adipose tissue (VAT) and liver fat reduction', 'Visceral and Liver Fat']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}]",42.0,0.032867,"RESULTS
HIIT and MICT significantly reduced VAT over 3 months (-350 [-548 to -153]","[{'ForeName': 'Jenna L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Holland', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Gregore I', 'Initials': 'GI', 'LastName': 'Mielke', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Bailey', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Leveritt', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sjaan R', 'Initials': 'SR', 'LastName': 'Gomersall', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Alex V', 'Initials': 'AV', 'LastName': 'Rowlands', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22833']
3253,32479903,Efficacy of antimicrobial photodynamic therapy with chloro-aluminum phthalocyanine on periodontal clinical parameters and salivary GSH and MDA levels in patients with periodontitis.,"The purpose of this study was to evaluate the efficacy of antimicrobial photodynamic therapy (aPDT) with chloro-aluminum phthalocyanine (AlClPc) on several periodontal parameters and salivary glutathione (GSH) and MDA (malondialdehyde) levels in periodontal sites presenting periodontitis. Randomized clinical trial, comprising 40 test group (TG) sites and 23 control group (CG) sites. The TG was treated with scaling and root planning (SRP) and aPDT, and CG, only with SRP. Visible plaque index [VPI], gingival bleeding index [GBI], bleeding on probing [BOP], probing depth [PD] and clinical attachment level [CAL] were calculated and saliva samples were taken at baseline (T 0 ), three (T 3 ) and six months (T 6 ). Data was analyzed by the Wilcoxon and Mann-Whitney tests. An intragroup analysis indicated significant differences at T 3 and T 6 for GBI, CAL and GSH only in the CG (p < 0.05). For BOP, a significant decrease was observed only in the TG between T 0 and T 6 (p = 0.008). No significant differences were observed for VPI, BOP and MDA. In the intergroup analysis, significant differences were observed for GBI at T 6 (p = 0.041), and for GSH at T 3 (p = 0.031), being higher in the TG. Although aPDT with AlClPc did not present statistically proven benefits, but the employed periodontal treatment resulted in decreased BOP, PD, CAL and MDA after 3 and 6 months of treatment. In addition, the lower need for glutathione production may initially suggest an additional benefit of AlClPc aPDT in the early reestablishment of the balance between oxidative and non-oxidative agents related to oxidative stress.",2020,"In the intergroup analysis, significant differences were observed for GBI at T 6 (p = 0.041), and for GSH at T 3 (p = 0.031), being higher in the TG.","['patients with periodontitis', 'periodontal sites presenting periodontitis']","['antimicrobial photodynamic therapy (aPDT) with chloro-aluminum phthalocyanine (AlClPc', 'scaling and root planning (SRP) and aPDT, and CG', 'antimicrobial photodynamic therapy with chloro-aluminum phthalocyanine']","['Visible plaque index [VPI], gingival bleeding index [GBI], bleeding on probing [BOP], probing depth [PD] and clinical attachment level [CAL', 'several periodontal parameters and salivary glutathione (GSH) and MDA (malondialdehyde) levels', 'periodontal clinical parameters and salivary GSH and MDA levels', 'BOP, PD, CAL and MDA', 'VPI, BOP and MDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0051520', 'cui_str': 'aluminum phthalocyanine'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0042454', 'cui_str': 'Velopharyngeal insufficiency'}]",,0.030644,"In the intergroup analysis, significant differences were observed for GBI at T 6 (p = 0.041), and for GSH at T 3 (p = 0.031), being higher in the TG.","[{'ForeName': 'Davi Neto de Araújo', 'Initials': 'DNA', 'LastName': 'Silva', 'Affiliation': 'DDS, MS, PhD Student, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Natalia Teixeira da', 'Initials': 'NTD', 'LastName': 'Silva', 'Affiliation': 'DDS, Post graduate Student, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Israel Alexandre de Araújo', 'Initials': 'IAA', 'LastName': 'Sena', 'Affiliation': 'DDS, MS, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Marcela Letícia da Silva', 'Initials': 'MLDS', 'LastName': 'Azevedo', 'Affiliation': 'DDS, MS, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Francisco Leonardo da Silva', 'Initials': 'FLDS', 'LastName': 'Júnior', 'Affiliation': 'DDS, MS, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Roseane Carvalho', 'Initials': 'RC', 'LastName': 'Vasconcelos', 'Affiliation': 'DDS, MS, PhD, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Maiara', 'Initials': 'M', 'LastName': 'de Moraes', 'Affiliation': 'DDS, MS, PhD, Professor Department of Health Sciences, Center for Biological and Health Sciences, Medicine, RuralFederal University of Semi-Árido (UFERSA), Mossoró, Rio Grande do Norte/RN, Brazil.'}, {'ForeName': 'João Paulo Figueiró', 'Initials': 'JPF', 'LastName': 'Longo', 'Affiliation': 'DDS, MS, PhD, Professor, Department of Genetics and Morphology, Institute of Biological Sciences, University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Aurigena Antunes', 'Initials': 'AA', 'LastName': 'de Araújo', 'Affiliation': 'DDS, MS, PhD, Professor, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Ana Rafaela Luz de Aquino', 'Initials': 'ARLA', 'LastName': 'Martins', 'Affiliation': 'DDS, MS, PhD, Professor, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil. Electronic address: anarafaela.luz@terra.com.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101843']
3254,32480076,Microstructural white matter changes following gait training with Hybrid Assistive Limb initiated within 1 week of stroke onset.,"The early initiation of robot-assisted gait training in patients with acute stroke could promote neuroplasticity. The aim of this study was to clarify the microstructural changes of white matter associated with gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI). Patients with first-ever stroke and requiring a walking aid started gait training within 1 week of stroke onset. The patients were quasi-randomly assigned either to the conventional physical therapy (CPT) group or gait training using HAL (HAL) group. Motor function and DTI were examined at baseline and after 3-5 months. Voxel-based statistical analyses of fractional anisotropy (FA) images were performed using diffusion metric voxel-wise analyses. Volume of interest (VOI)-based analyses were used to assess changes in FA (ΔFA). Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study. There were improvements in motor function and independency in the CPT and HAL groups (p < .001). Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001). Gait training using HAL initiated within 1 week after stroke onset facilitated the recovery of inter-hemispheric communication and prevented the progression of Wallerian degeneration of the affected pyramidal tract.",2020,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","['Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study', 'Patients with first-ever stroke and requiring a walking aid started gait training within 1\xa0week of stroke onset', 'patients with acute stroke']","['Gait training using HAL', 'gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI', 'robot-assisted gait training', 'conventional physical therapy (CPT) group or gait training using HAL (HAL', 'gait training with Hybrid Assistive Limb']","['Motor function and DTI', 'changes in FA (ΔFA', 'contra-lesional rostrum of the corpus callosum', 'motor function and independency', 'FA in the ipsi-lesional cerebral peduncle']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0152322', 'cui_str': 'Structure of rostrum of corpus callosum'}, {'cui': 'C0007793', 'cui_str': 'Cerebral peduncle structure'}]",27.0,0.0293157,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ando', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Yokota', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan; Department of Stroke Rehabilitation, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: cyokota@ncvc.go.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Koshino', 'Affiliation': 'Department of Systems and Informatics, Hokkaido Information University, Ebetsu, Japan. Electronic address: koshino@do-johodai.ac.jp.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Yasuno', 'Affiliation': 'Department of Psychiatry, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan. Electronic address: yasunof@ncgg.go.jp.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Akihide', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Industrial-Academic Collaboration, Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: ayamamot@ncvc.go.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Odani', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Neurology, National Hospital Organization Niigata National Hospital, Kashiwazaki, Japan. Electronic address: nakajima.takashi.ud@mail.hosp.go.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Nuclear Medicine and Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Tatsumi', 'Affiliation': 'Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: tatsumi@ncvc.go.jp.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116939']
3255,32480103,Safety and placement stability for the Children's Home Network kinship navigator program.,"BACKGROUND
With the passage of the Families First Prevention Act, kinship navigator programs have growing support as an intervention to connect kinship families to needed resources. Growing evidence has helped to showcase the outcomes, but no study has shared follow up outcomes past twelve months.
OBJECTIVE
This study examined the 12, 24 and 36 month follow up child safety (substantiated abuse record) and placement stability (disruption in placement) outcomes from state administered secondary data for children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN).
SETTING
Study participants were 240 (60 in each group) randomly selected kinship caregivers who were enrolled in four treatment groups in CHN-KN (Standard Kinship Navigator, Kinship Navigator with Innovations, Kinship Navigator with Peer-to-Peer only, and Usual Child Welfare).
METHODS
Repeated measures anovas were used to show between group differences for each study group.
RESULTS
Results show that children living with caregivers who received Kinship Navigator Programs (Kinship Navigator Peer to Peer and Kinship Navigator with Innovations) were the least likely to be involved in a substantiation of child abuse or neglect and most likely to remain in the home of a relative at 12, 24 and 36 month follow up.
CONCLUSIONS
Results suggest that the kinship navigator programs could improve child safety and placement stability. This study can help to inform the replication of the CHN-KN model and provide additional supported evidence to inform practice.",2020,"outcomes from state administered secondary data for children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN).
","[""Children's Home Network kinship navigator program"", 'Study participants were 240 (60 in each group) randomly selected kinship caregivers who were enrolled in four treatment groups in', ""children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN"", 'children living with caregivers']","['CHN-KN (Standard Kinship Navigator, Kinship Navigator with Innovations, Kinship Navigator with Peer-to-Peer only, and Usual Child Welfare', 'Kinship Navigator Programs (Kinship Navigator Peer to Peer and Kinship Navigator with Innovations']","['Safety and placement stability', 'child safety (substantiated abuse record) and placement stability (disruption in placement', 'child safety and placement stability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",240.0,0.0249446,"outcomes from state administered secondary data for children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN).
","[{'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Littlewood', 'Affiliation': 'The University of South Florida School of Social Work, Tampa, FL, United States. Electronic address: littlewood@usf.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Cooper', 'Affiliation': ""Children's Home Network, Tampa, FL, 33620, United States. Electronic address: lcooper@childrenshomenetwork.org.""}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'The University of South Florida, Tampa, FL, United States. Electronic address: apandey47@gmail.com.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104506']
3256,32481239,"Sensorimotor and gait training improves proprioception, nerve function, and muscular activation in patients with diabetic peripheral neuropathy: a randomized control trial.","OBJECTIVES
To examine the effect of sensorimotor and gait training on proprioception, nerve function, and muscle activation in diabetic peripheral neuropathy (DPN) patients.
METHODS
Thirty-eight (25 male and 13 female) participants with DPN were selected and randomly allocated to intervention and control group. Participants in the intervention group were provided sensorimotor and gait training for eight weeks (3 days/week) along with diabetes and foot care education; participants in the control group received diabetes and foot care education only. Outcome measures involved proprioception, nerve conduction studies of peroneal and tibial nerve, and activation of lower limb muscles and multifidus while standing with eyes open and eyes closed, and treadmill walking.
RESULTS
Mixed ANOVA revealed significant time effect and time×group interaction of proprioception in all four directions (p<0.05). The conduction velocity of peroneal nerve revealed significant time effect (p=0.007) and time×group interaction (p=0.022). Interaction effect was found to be significant for medial gastrocnemius and multifidus while standing with eyes open as well as with eyes closed (p≤0.004). Only multifidus showed significant group (p=0.002) and interaction effect (p=0.003) during walking.
CONCLUSIONS
Sensorimotor and gait training is an effective tool for improvement of proprioception and nerve function. It benefits muscle activation around ankle and multifidus during postural control and walking in DPN patients. Clinical Trials Registry - India, National Institute of Medical Statistics (Indian Council of Medical Research): Registration Number - CTRI/2017/08/009328.",2020,The conduction velocity of peroneal nerve revealed significant time effect (p=0.007) and time×group interaction (p=0.022).,"['Thirty-eight', 'diabetic peripheral neuropathy (DPN) patients', 'patients with diabetic peripheral neuropathy', 'DPN patients', '25 male and 13 female) participants with DPN']","['control group received diabetes and foot care education only', 'Sensorimotor and gait training', 'sensorimotor and gait training']","['proprioception, nerve function, and muscular activation', 'proprioception, nerve function, and muscle activation', 'interaction effect', 'proprioception, nerve conduction studies of peroneal and tibial nerve, and activation of lower limb muscles and multifidus while standing with eyes open and eyes closed, and treadmill walking', 'time effect and time×group interaction of proprioception', 'Interaction effect', 'conduction velocity of peroneal nerve revealed significant time effect']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1161230', 'cui_str': 'Foot care education'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C0442035', 'cui_str': 'Peroneal'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C0031173', 'cui_str': 'Structure of common peroneal nerve'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.0376785,The conduction velocity of peroneal nerve revealed significant time effect (p=0.007) and time×group interaction (p=0.022).,"[{'ForeName': 'Irshad', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Diabetes Research Group, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Diabetes Research Group, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Majumi M', 'Initials': 'MM', 'LastName': 'Noohu', 'Affiliation': 'Human Performance Lab, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'Mohd Yakub', 'Initials': 'MY', 'LastName': 'Shareef', 'Affiliation': 'Ansari Health Centre, Jamia Millia Islamia (A Central University), New Delhi, India.'}, {'ForeName': 'M Ejaz', 'Initials': 'ME', 'LastName': 'Hussain', 'Affiliation': 'Diabetes Research Group, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (A Central University), New Delhi, India.'}]",Journal of musculoskeletal & neuronal interactions,[]
3257,32481240,Effects of aquatic exercises on postural control and hand function in Multiple Sclerosis: Halliwick versus Aquatic Plyometric Exercises: a randomised trial.,"OBJECTIVES
Postural control and hand dexterity are significantly impaired in people with multiple sclerosis (pwMS). Aquatic interventions may have additional benefits in the treatment of pwMS. The purpose of this study is to compare the effects of two different aquatic exercises on postural control and hand function.
METHODS
Thirty pwMS, relapsing-remitting type were randomly divided into a Halliwick (Hallw) and an Aquatic Plyometric Exercise (APE) group. The Limits of Stability test was used to evaluate postural control using the Biodex Balance System. The Nine-Hole Peg Test was used to evaluate hand dexterity. Both exercise interventions were performed twice a week for 8 weeks, in a pool with a depth of 120 cm and water temperature of 30-31°C.
RESULTS
Limits of stability improved significantly in both groups (p<0.05) and Hallw group completed the test in a significantly shorter time (p<0.05). Hand dexterity improved significantly in both groups (p<0.01). Following intergroup analysis, Hallw group showed significantly higher improvement in hand dexterity and overall limits of stability test score (p<0.05).
CONCLUSIONS
This study provides evidence that both Halliwick and APE are effective to treat balance and hand dexterity. This paper is the first evidence on APE for pwMS and showed that it is safe and improved trunk control and hand dexterity.",2020,"RESULTS
Limits of stability improved significantly in both groups (p<0.05) and Hallw group completed the test in a significantly shorter time (p<0.05).","['Thirty pwMS, relapsing-remitting type', 'people with multiple sclerosis (pwMS', 'Multiple Sclerosis']","['Halliwick (Hallw) and an Aquatic Plyometric Exercise (APE', 'aquatic exercises', 'Aquatic Plyometric Exercises']","['hand dexterity and overall limits of stability test score', 'Limits of stability', 'Hand dexterity', 'postural control and hand function']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}]",,0.030325,"RESULTS
Limits of stability improved significantly in both groups (p<0.05) and Hallw group completed the test in a significantly shorter time (p<0.05).","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gurpinar', 'Affiliation': 'Dokuz Eylul University School of Physical Therapy and Rehabilitation, Izmir, Turkey.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Kara', 'Affiliation': 'Dokuz Eylul University School of Physical Therapy and Rehabilitation, Izmir, Turkey.'}, {'ForeName': 'Egemen', 'Initials': 'E', 'LastName': 'Idiman', 'Affiliation': 'Private Clinic, Izmir, Turkey.'}]",Journal of musculoskeletal & neuronal interactions,[]
3258,32481241,Therapeutic value of kinesio taping in reducing lower back pain and improving back muscle endurance in adolescents with hemophilia.,"OBJECTIVE
This study evaluated whether the use of kinesio taping (KT) would enhance the effect of physical therapy in relieving pain, improving muscle endurance, and boosting functional capacity in adolescents with hemophilia who experience low back pain.
METHODS
Forty-five adolescents with hemophilia (age; 10-13 years) assigned randomly into three treatment arms; KT applied paraspinal alongside a physical exercise program conducted three times/week for three successive months (KT group; n=15), placebo taping plus physical exercise (Placebo group; n=15), or physical exercise only (Control group; n=15). Lower back pain, back muscle endurance, and functional capacity assessed pre- and post-treatment.
RESULTS
Lower back pain reduced significantly in the KT group as compared to the control group (P=.001), but not to the placebo group (P=.19). Back muscle endurance increased significantly in the KT group relative to either the placebo (P=.004) or the control group (P=.043). Additionally, functional capacity improved significantly in the KT group as compared to the control (P=.039) group but not to the placebo group (P=.58).
CONCLUSION
KT is an effective adjunctive therapy to reduce lower back pain, improve back muscle endurance, and enhance functional capacity in adolescents with hemophilia.",2020,"RESULTS
Lower back pain reduced significantly in the KT group as compared to the control group (P=.001), but not to the placebo group (P=.19).","['Forty-five adolescents with hemophilia (age; 10-13 years', 'adolescents with hemophilia who experience low back pain', 'adolescents with hemophilia']","['kinesio taping (KT', 'placebo taping plus physical exercise (Placebo', 'KT', 'kinesio taping', 'physical exercise', 'physical therapy', 'placebo']","['back pain', 'Lower back pain, back muscle endurance, and functional capacity assessed pre- and post-treatment', 'Back muscle endurance', 'functional capacity', 'lower back pain and improving back muscle endurance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",45.0,0.0300428,"RESULTS
Lower back pain reduced significantly in the KT group as compared to the control group (P=.001), but not to the placebo group (P=.19).","[{'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Αzab', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Reham H', 'Initials': 'RH', 'LastName': 'Diab', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, Collage of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Journal of musculoskeletal & neuronal interactions,[]
3259,32481255,A clinical study on safety and efficacy of Naesohwajung-tang on functional dyspepsia.,"BACKGROUND
Functional dyspepsia (FD) is a chronic gastrointestinal disorder diagnosed with dyspeptic symptoms, such as recurrent or persistent postprandial fullness, epigastric pain, burning, and early satiety without any evidence of structural abnormality. In traditional Korean medicine, herbal remedies are one of the preferred treatments for gastrointestinal symptoms. Among them, Naesohwajung-tang (NHT) has been frequently prescribed to improve dyspeptic symptoms for a long time. However, the safety and efficacy of NHT still remain unclear. Therefore, this study aims to evaluate the safety and efficacy of NHT in patients with FD using a randomized controlled trial.
METHODS
This is a protocol for a multi-center, randomized, double-blind, placebo-controlled trial. Total 116 participants aged between 19 and 75 years diagnosed with FD according to the Rome IV diagnosis criteria will be recruited at two Korean medicine hospitals. Eligible participants will be randomly assigned to either a NHT group or a placebo group in a 1:1 ratio. Each participant will be instructed to take NHT or placebo granules three times a day for 4 weeks. The primary outcome is the change in the total dyspepsia symptom score to confirm the efficacy of NHT. The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments. Adverse events will be evaluated at every visit. The primary endpoint will be measured at week 4, and then re-evaluated at week 8 through a follow-up phone visit.
DISCUSSION
This trial will evaluate the safety and efficacy of NHT as a treatment of FD. The results of this trial will not only verify whether NHT improves FD symptoms and gastric myoelectrical activity, but also clarify those correlations.
TRIAL REGISTRATION NUMBER
CRIS KCT0003405.",2020,"The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments.","['Eligible participants', 'Total 116 participants aged between 19 and 75 years diagnosed with FD according to the Rome IV diagnosis criteria will be recruited at two Korean medicine hospitals', 'patients with FD']","['NHT', 'Naesohwajung-tang', 'Naesohwajung-tang (NHT', 'NHT or placebo', 'placebo']","['total dyspepsia symptom score', 'efficacy of NHT', 'functional dyspepsia', 'dyspeptic symptoms', 'Adverse events', 'overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments', 'FD symptoms and gastric myoelectrical activity', 'safety and efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0430689', 'cui_str': 'Electromyography of stomach'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",116.0,0.659328,"The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, Damum questionnaire, FD-related quality of life, electrogastrography, and safety assessments.","[{'ForeName': 'Na-Yeon', 'Initials': 'NY', 'LastName': 'Ha', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seulki', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seok-Jae', 'Initials': 'SJ', 'LastName': 'Ko', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jinsung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000019910']
3260,32481297,"Evaluation on the effect of acupuncture on patients with sepsis-induced myopathy (ACU-SIM pilot study): A single center, propensity-score stratified, assessor-blinded, prospective pragmatic controlled trial.","BACKGROUND
Sepsis-induced myopathy (SIM) is a disease that causes motor dysfunction in patients with sepsis. There is currently no targeted treatment for this disease. Acupuncture has shown considerable efficacy in the treatment of sepsis and muscle weakness. Therefore, our research aims to explore the effects of acupuncture on the improvement of muscle structure and function in SIM patients and on activities of daily living.
METHODS
The ACU-SIM pilot study is a single-center, propensity-score stratified, assessor-blinded, prospective pragmatic controlled trial (pCT) with a 1-year follow-up period. This study will be deployed in a multi-professional critical care department at a tertiary teaching hospital in Guangzhou, China. Ninety-eight intensive care unit subjects will be recruited and assigned to either the control group or the acupuncture group. Both groups will receive basic treatment for sepsis, and the acupuncture group will additionally receive acupuncture treatment. The primary outcomes will be the rectus femoris cross-sectional area, the Medical Research Council sum-score and time-to-event (defined as all-cause mortality or unplanned readmission to the intensive care unit due to invasive ventilation). The activities of daily living will be accessed by the motor item of the Functional Independence Measure. Recruitment will last for 2 years, and each patient will have a 1-year follow-up after the intervention.
DISCUSSION
There is currently no research on the therapeutic effects of acupuncture on SIM. The results of this study may contribute to new knowledge regarding early muscle atrophy and the treatment effect of acupuncture in SIM patients, and the results may also direct new approaches and interventions in these patients. This trial will serve as a pilot study for an upcoming multicenter real-world study.
TRIAL REGISTRATION
Chinese Clinical Trials Registry: ChiCTR-1900026308, registered on September 29th, 2019.",2020,"The results of this study may contribute to new knowledge regarding early muscle atrophy and the treatment effect of acupuncture in SIM patients, and the results may also direct new approaches and interventions in these patients.","['Ninety-eight intensive care unit subjects', 'SIM patients and on activities of daily living', 'multi-professional critical care department at a tertiary teaching hospital in Guangzhou, China', 'patients with sepsis-induced myopathy (ACU-SIM pilot study', 'patients with sepsis']","['acupuncture', 'Acupuncture', 'acupuncture treatment']","['rectus femoris cross-sectional area, the Medical Research Council sum-score and time-to-event (defined as all-cause mortality or unplanned readmission to the intensive care unit due to invasive ventilation']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.162219,"The results of this study may contribute to new knowledge regarding early muscle atrophy and the treatment effect of acupuncture in SIM patients, and the results may also direct new approaches and interventions in these patients.","[{'ForeName': 'Wei-Tao', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Intensive Care Unit, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Meizhou Hospital of Traditional Chinese Medicine, Meizhou.'}, {'ForeName': 'Ying-Bin', 'Initials': 'YB', 'LastName': 'Zhou', 'Affiliation': 'The First Clinical School of Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Dong-Hua', 'Initials': 'DH', 'LastName': 'Liu', 'Affiliation': 'The First Clinical School of Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Zhi-Long', 'Initials': 'ZL', 'LastName': 'Peng', 'Affiliation': 'The First Clinical School of Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Intensive Care Unit, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Nuo', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'The university of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Lei', 'Affiliation': 'Intensive Care Unit, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Acupuncture and Rehabilitation, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Chun-Zhi', 'Initials': 'CZ', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Xin-Feng', 'Initials': 'XF', 'LastName': 'Lin', 'Affiliation': 'Intensive Care Unit, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Neng-Gui', 'Initials': 'NG', 'LastName': 'Xu', 'Affiliation': 'Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Shao-Xiang', 'Initials': 'SX', 'LastName': 'Xian', 'Affiliation': 'Ling-Nan Medical Research Center, Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Lu', 'Affiliation': 'Medical College of Acupuncture and Rehabilitation.'}]",Medicine,['10.1097/MD.0000000000020233']
3261,32481298,Clinical trial for conventional medicine integrated with traditional Chinese medicine (TCM) in the treatment of patients with chronic kidney disease.,"BACKGROUND
The prevalence of chronic kidney disease (CKD) has been rapidly increasing and has become one of the most concerned global health problems. It is of good importance to improve therapeutic efficiency of CKD and delay disease progression to end stage renal disease (ESRD). Traditional Chinese Medicine (TCM) is a widely used complementary therapy for patients with CKD. The aim of this study is to evaluate whether basic treatment combined with Chinese herbs mixture Qi Gui Yi Shen decoction could achieve better therapeutic effect on CKD patients.
METHODS
To determine whether traditional Chinese medicine Qi Gui Yi Shen decoction could achieve better therapeutic effect, we will conduct a randomized controlled trial. A total of 100 CKD patients that meet the inclusion criteria will be enrolled and divided into 2 groups: Qi Gui Yi Shen group (QGYS group) and placebo group. Each group will receive 6-monthly basic treatment in combination with TCM or placebo 3 times per day. Efficacy of Qi Gui Yi Shen decoction is evaluated by analyzing renal function and TCM symptoms, other efficacy assessments include serum level of PAI-I, expression of transforming growth factor beta1 (TGF-beta1). Routine blood count, plasma albumin (ALB), and alanine transaminase (ALT) are evaluated as side effect and safety profile.
DISCUSSION
The results from the clinical trial will provide evidence for the effectiveness and safety of Qi Gui Yi Shen Decoction as a treatment for CKD patients. Furthermore, this will propose a new theory and method for CKD treatment.
TRIAL REGISTRATION
Registered with Chinese Clinical Trials Registry at www.chictr.org. (Registration number: ChiCTR1900021622) on 1 March 2019.",2020,The results from the clinical trial will provide evidence for the effectiveness and safety of Qi Gui Yi Shen Decoction as a treatment for CKD patients.,"['100 CKD patients that meet the inclusion criteria will be enrolled and divided into 2 groups', 'CKD patients', 'patients with CKD', 'chronic kidney disease (CKD', 'patients with chronic kidney disease']","['Qi Gui Yi Shen decoction', 'Qi Gui Yi Shen group (QGYS group) and placebo', 'TCM or placebo', 'Qi Gui Yi Shen Decoction', 'Chinese herbs mixture', 'conventional medicine integrated with traditional Chinese medicine (TCM', 'Traditional Chinese Medicine (TCM', 'traditional Chinese medicine Qi Gui Yi Shen decoction']","['Routine blood count, plasma albumin (ALB), and alanine transaminase (ALT', 'renal function and TCM symptoms, other efficacy assessments include serum level of PAI-I, expression of transforming growth factor beta1 (TGF-beta1', 'side effect and safety profile']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032145', 'cui_str': 'Plasminogen activator inhibitor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1704256', 'cui_str': 'Transforming Growth Factor Beta 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.0630156,The results from the clinical trial will provide evidence for the effectiveness and safety of Qi Gui Yi Shen Decoction as a treatment for CKD patients.,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xi', 'Affiliation': 'The First Affiliated Hospital of Soochow University.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Suzhou Municipal Hospital, Suzhou.'}, {'ForeName': 'Like', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Zhangjiagang TCM Hospital, Zhangjiagang.'}, {'ForeName': 'Xiaoyi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'The First Affiliated Hospital of Soochow University.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The First Affiliated Hospital of Soochow University.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Minggang', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Soochow University.'}]",Medicine,['10.1097/MD.0000000000020234']
3262,32481305,"A multi-center, randomized, double-blind, placebo-parallel controlled trial for the efficacy and safety of shenfuqiangxin pills in the treatment of chronic heart failure (Heart-Kidney yang deficiency syndrome).","BACKGROUND
Heart failure (HF) is the final stage of various cardiac diseases with poor prognosis. The integrated traditional Chinese medicine (TCM) and western medicine therapy has been considered as a prospective therapeutic strategy for chronic heart failure (CHF). There have been small clinical trials and experimental studies to demonstrate the efficacy of Shenfu Qiangxin Pills (SFQX) for treating CHF, however, there is still a lack of further high-quality trial. This paper describes the protocol for the clinical assessment of SFQX in CHF (heart-kidney Yang deficiency syndrome) patients.
METHODS
A randomized, double-blind, parallel-group, placebo-controlled, multi-center trial will assess the efficacy and safety of SFQX in the treatment of CHF. 352 patients with CHF (heart-kidney Yang deficiency syndrome) from 22 hospitals in China will be enrolled. Besides their standardized western medicine, patients will be randomized to receive treatment of either SFQX or placebo for 12 weeks. The primary outcome is the plasma N-terminal pro-B-type natriuretic peptide levels, which will be measured uniformly by the central laboratory. The secondary outcomes include composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores.
DISCUSSION
The integrated TCM and western medicine therapy has developed into a treatment model in China. The rigorous design of the trial will assure an objective and scientific assessment of the efficacy and safety of SFQX in the treatment of CHF.
TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR2000028777 (registered on January 3, 2020).",2020,"The secondary outcomes include composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores.
","['352 patients with CHF (heart-kidney Yang deficiency syndrome) from 22 hospitals in China will be enrolled', 'chronic heart failure (Heart-Kidney yang deficiency syndrome', 'CHF (heart-kidney Yang deficiency syndrome) patients']","['SFQX or placebo', 'integrated traditional Chinese medicine (TCM) and western medicine therapy', 'Shenfu Qiangxin Pills (SFQX', 'shenfuqiangxin pills', 'SFQX', 'placebo']","['efficacy and safety', 'composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores', 'plasma N-terminal pro-B-type natriuretic peptide levels, which will be measured uniformly by the central laboratory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0085258', 'cui_str': 'Yang deficiency'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1528398', 'cui_str': 'Shen-Fu'}, {'cui': 'C2355395', 'cui_str': 'qiangxin'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",352.0,0.220512,"The secondary outcomes include composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores.
","[{'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Dawu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'National priority R & D programmes (2018YFC1707410-02), Fuwai Hospital of Chinese Academy of Medical Sciences.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Hua', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaochang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}, {'ForeName': 'Keji', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'National Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.'}]",Medicine,['10.1097/MD.0000000000020271']
3263,32481314,"Chinese massage, Tui Na, combined with herbs improves clinical symptoms and regulates sex hormones in patients with mammary gland hyperplasia.","To study the effects of Tui Na therapy on patients with mammary gland hyperplasia.A total of 68 female patients with mammary gland hyperplasia were included in this retrospective study from May 2016 to May 2017 and assigned into control group (N = 34) treated with Rupixiao only (a proprietary Chinese medicine) or Tui Na group (N = 34) treated with Tui Na (Chinese massage) combined with Rupixiao. The pain intensity (visual analogous scale, VAS) and serum levels of luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and progesterone (P) were examined before and after the treatment.The efficacies were 94.1% (32/34) in the Tui Na group and 76.5% (26/34) in the control group (P = .04). After treatment, VAS in Tui Na groups was significantly lower than that in control group (2.1 ± 1.1 vs 3.1 ± 1.1, P < .05). After follow-up for five months, the recurrence rates were 12.5% (4/32) in the Tui Na group and 23.1% (6/26) in the control group (P = .01). The levels of all 4 hormones in the Tui Na group increased significantly after treatment. In control group, only LH and E2 levels were significantly increased after treatment.In patients with mammary gland hyperplasia, Tui Na combined with Rupixiao could improve clinical symptoms, regulate sex hormone levels, and decrease the recurrence rate than Rupixiao alone. Our finding suggests that Tui Na can be potentially used for the treatment of mammary gland hyperplasia.",2020,"The pain intensity (visual analogous scale, VAS) and serum levels of luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and progesterone (P) were examined before and after the treatment.","['patients with mammary gland hyperplasia', '68 female patients with mammary gland hyperplasia']","['Rupixiao only (a proprietary Chinese medicine) or Tui Na group (N\u200a=\u200a34) treated with Tui Na (Chinese massage) combined with Rupixiao', 'Tui Na therapy', 'Chinese massage, Tui Na, combined with herbs']","['pain intensity (visual analogous scale, VAS) and serum levels of luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and progesterone (P', 'clinical symptoms, regulate sex hormone levels', 'LH and E2 levels', 'recurrence rates', 'recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0929301', 'cui_str': 'Glandular structure of breast'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0326732', 'cui_str': 'Tui'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019240', 'cui_str': 'Herb'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",68.0,0.0190609,"The pain intensity (visual analogous scale, VAS) and serum levels of luteinizing hormone (LH), estradiol (E2), prolactin (PRL), and progesterone (P) were examined before and after the treatment.","[{'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Massage, Traditional Chinese Medicine Hospital of Xinjiang Uyghur Autonomous Region, Urumqi, Xinjiang, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Ruan', 'Affiliation': ''}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Yongtao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yujiang', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Zhijin', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': ''}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020300']
3264,32481355,Effects of virtual reality immersive training with computerized cognitive training on cognitive function and activities of daily living performance in patients with acute stage stroke: A preliminary randomized controlled trial: Retraction.,,2020,,['patients with acute stage stroke'],['virtual reality immersive training with computerized cognitive training'],['cognitive function and activities of daily living performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.160731,,[],Medicine,['10.1097/MD.0000000000020598']
3265,32481364,"Study on efficacy and safety of Huangqi Guizhi Wuwu decoction treatment for oxaliplatin induced peripheral neurotoxicity: A protocol for a randomized, controlled, double-blind, multicenter trial.","BACKGROUND
Oxaliplatin can cause severe peripheral neurotoxicity, which is an important reason for clinical oxaliplatin reduction and cessation of treatment. Oxaliplatin induced peripheral neurotoxicity (OIPN) can cause paresthesia and dysesthesia, even affect the quality life of patients. So far, there are no recognized and effective measures to prevent OIPN. Huangqi Guizhi Wuwu decoction is a classical prescription of ancient Chinese medicine recorded in ""the synopsis of the Golden Chamber,"" which can be used in the treatment of various neurotoxicity. However, there is a lack of large-scale and high-quality clinical studies on the prevention of OIPN by Huangqi Guizhi Wuwu decoction. The purpose of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction on preventing OIPN.
METHODS/DESIGN
This study is a randomized, controlled, double-blind, and multicenter clinical trial. Three hundred sixty patients will be randomly assigned into Huangqi Guizhi Wuwu decoction group and Huangqi Guizhi Wuwu decoction mimetic agent group. Patients will receive chemotherapy with FOLFOX of 8 cycles of 3 weeks with Traditional Chinese Medicine (TCM) for 6 months and 1-year follow-up. The primary outcome measure is the differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment. The secondary outcome measure is the improvement in other symptoms associated with chemotherapy. Four methods will be used to evaluate the efficacy of neurotoxicity, including oxaliplatin specific toxicity grading standard (Levi classification); CTCAE4.02 version; EORTC QLQ-CIPN20 scale, EORTC QLQ C30 scale, and EORTC QLQ-CR29 scale are used at the same time; Electromyography.
DISCUSSION
This study will provide objective evidences to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction on preventing OIPN.
TRIAL REGISTRATION
Clinical Trials.gov (Identifier: NCT04261920).",2020,"Oxaliplatin induced peripheral neurotoxicity (OIPN) can cause paresthesia and dysesthesia, even affect the quality life of patients.",['Three hundred sixty patients'],"['oxaliplatin', 'Huangqi Guizhi Wuwu decoction', 'Wuwu decoction', 'Huangqi Guizhi Wuwu Decoction', 'Huangqi Guizhi', 'Oxaliplatin', 'Huangqi Guizhi Wuwu decoction group and Huangqi Guizhi Wuwu decoction mimetic agent group', 'Traditional Chinese Medicine (TCM', 'chemotherapy with FOLFOX']","['incidence of chronic neurotoxicity of grade 2 and above during and after treatment', 'peripheral neurotoxicity', 'efficacy and safety', 'peripheral neurotoxicity (OIPN', 'efficacy of neurotoxicity, including oxaliplatin specific toxicity grading standard (Levi classification); CTCAE4.02 version; EORTC QLQ-CIPN20 scale, EORTC QLQ C30 scale, and EORTC QLQ-CR29 scale']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0696679', 'cui_str': 'Astragalus propinquus root extract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",360.0,0.151994,"Oxaliplatin induced peripheral neurotoxicity (OIPN) can cause paresthesia and dysesthesia, even affect the quality life of patients.","[{'ForeName': 'Xiao-Man', 'Initials': 'XM', 'LastName': 'Wei', 'Affiliation': 'The First Clinical College of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital With Nanjing Medical University.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Shu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Zhi-Wei', 'Initials': 'ZW', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Wu', 'Affiliation': 'Department of Surgical Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital.'}, {'ForeName': 'Wen-Wei', 'Initials': 'WW', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, The Third Affiliated Hospital of Soochow University, Changzhou.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Wei-Xing', 'Initials': 'WX', 'LastName': 'Shen', 'Affiliation': 'The First Clinical College of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Clinical College of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Jun-Yi', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Feng-Jiao', 'Initials': 'FJ', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital With Nanjing Medical University.'}, {'ForeName': 'Qing-Feng', 'Initials': 'QF', 'LastName': 'Yin', 'Affiliation': 'Jiangsu Famous Medical Technology Co., Ltd, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Hai-Bo', 'Initials': 'HB', 'LastName': 'Cheng', 'Affiliation': 'The First Clinical College of Nanjing University of Chinese Medicine.'}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Gu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital With Nanjing Medical University.'}]",Medicine,['10.1097/MD.0000000000019923']
3266,32481369,Proximal versus distal adductor canal blocks for total knee arthroplasty: A protocol for randomized controlled trial.,"BACKGROUND
Currently, there remains a paucity of literature about the efficiency of proximal adductor canal block (PACB) versus distal adductor canal block (DACB) for pain management after total knee arthroplasty (TKA). The purpose of this study is to perform a randomized controlled trial to compare the efficiency of PACB versus DACB for early postoperative pain treatment after TKA.
METHODS
This study is a 2-arm, parallel-group, randomized controlled trial that is conducted at a single university hospital in China. Subjects presenting for unilateral TKA are randomized in a 1:1 ratio to either a PACB or DACB group. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. Secondary outcomes include quadriceps strength, pain scores, distance ambulated, and patient satisfaction. Continuous variables are compared using Student t test.
RESULTS
This clinical trial is expected to provide evidence of whether the PACB and DACB provide similar analgesia after TKA.
TRIAL REGISTRATION
This study protocol was registered in Research Registry (researchregistry5440).",2020,Subjects presenting for unilateral TKA are randomized in a 1:1 ratio to either a PACB or DACB group.,"['total knee arthroplasty', 'pain management after total knee arthroplasty (TKA', 'Subjects presenting for unilateral TKA', 'single university hospital in China', 'early postoperative pain treatment after TKA']","['PACB or DACB', 'PACB versus DACB', 'proximal adductor canal block (PACB) versus distal adductor canal block (DACB', 'Proximal versus distal adductor canal blocks']","['opioid consumption within the first 24\u200ahours following surgery', 'quadriceps strength, pain scores, distance ambulated, and patient satisfaction']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.340156,Subjects presenting for unilateral TKA are randomized in a 1:1 ratio to either a PACB or DACB group.,"[{'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019995']
3267,32481374,"The ""Warrior"" system: a new useful emergency simulator to train clinical pharmacists in emergency medicine.","Clinical pharmacists are indispensable providers of emergency medical services. However, the training of Chinese clinical pharmacists in medical emergency skills is apparently insufficient.The current study aimed to evaluate the effect of the ""Warrior"" emergency simulator application in the emergency medical education of clinical pharmacy students (CP students).The ""Warrior"" system, which contains a pharmacokinetics/pharmacodynamics-linked model and a drug database, was successfully employed to train CP students and improve their capability to deal with various medical emergency situations. Both an objective (in-class) test and the subjective Dundee Ready Education Environment Measure (DREEM) were administered to 20 CP students, randomly divided into an intervention group and a control group, to estimate the teaching effect of the ""Warrior"" system.The scores of CP students from the intervention group were significantly higher (P < .01) in the in-class test than the scores of students from the control group due to the diverse situational teaching using the ""Warrior"" system. The results of the DREEM showed that CP students from the intervention group obtained considerably better (P < .01) marks for ""students' perceptions of learning"" and ""students' perceptions of atmosphere"" than those from the control group. Furthermore, the intervention group scored much higher (P < .01) than the control group on the total DREEM.The ""Warrior"" system provides an excellent training path for clinical pharmacists that supplies a more realistic clinical simulation experience and significantly improves the teaching effect. The ""Warrior"" system exhibits high potential for future development in emergency medical education.",2020,"The scores of CP students from the intervention group were significantly higher (P < .01) in the in-class test than the scores of students from the control group due to the diverse situational teaching using the ""Warrior"" system.",['20 CP students'],"['Warrior"" emergency simulator application']",['scores of CP students'],"[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0135149,"The scores of CP students from the intervention group were significantly higher (P < .01) in the in-class test than the scores of students from the control group due to the diverse situational teaching using the ""Warrior"" system.","[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Basic Medical College, Guizhou University of Traditional Chinese Medicine, Guiyang.'}, {'ForeName': 'Yang-Yang', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine.'}, {'ForeName': 'Jing-Jie', 'Initials': 'JJ', 'LastName': 'Zhou', 'Affiliation': 'Tellyes Scientific Inc.'}, {'ForeName': 'Yan-Fei', 'Initials': 'YF', 'LastName': 'Liu', 'Affiliation': 'Tellyes Scientific Inc.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'School of Traditional Chinese Medicine, Guangdong Pharmaceutical University, Guangzhou, China.'}]",Medicine,['10.1097/MD.0000000000020047']
3268,32481390,A controlled study on the efficacy and quality of life of laparoscopic intersphincteric resection (ISR) and extralevator abdominoperineal resection (ELAPE) in the treatment of extremely low rectal cancer.,"BACKGROUND
The aim of this study is to compare the postoperative quality of life (QoL) and survival outcomes in lower rectal cancer (LRC) patients who undergo either laparoscopic- intersphincteric resection or extralevator abdominoperineal excision (L-ELAPE) after long-course neoadjuvant chemoradiation therapy (nCRT).
METHODS
This prospective, single-center, non-randomized, controlled, non-blinded, phase I/II clinical trial is designed to enroll 159 eligible LRC patients who achieved favorable response to long-course nCRT (2 × 25 Gy). After informed consent, the patients will be assigned into the laparoscopic intersphincteric resection group or L-ELAPE group according to their own will. Standard radical laparoscopic surgeries will be performed for every participant. Then every participant will be followed up for 3 years. The primary outcomes are scores of QoL questionnaire-core 30, QoL questionnaire-colorectum 29, Wexner incontinence score, International Prostate Symptom Score (for male), International Index of Erectile Function-5 (for male) and Female Sexual Function Index (for female). The secondary outcomes consist of incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes.
DISCUSSION
This is the first prospective clinical controlled trial to assess postoperative QoL and efficacy for LRC patients after favorable long-course nCRT. The result is expected to provide new evidence for a more detailed individualized treatment guideline for LRC.
TRIAL REGISTRATION
This trial was registered at Chinese Clinical Trial Registry (ChiCTR1800017512; ChiCTR.org) on August 2, 2018.",2020,"The secondary outcomes consist of incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes.
","['159 eligible LRC patients who achieved favorable response to long-course nCRT (2\u200a×\u200a25 Gy', 'extremely low rectal cancer', 'lower rectal cancer (LRC) patients who undergo either', 'LRC patients after favorable long-course nCRT', 'for male) and Female Sexual Function Index (for female', 'L-ELAPE) after long-course neoadjuvant chemoradiation therapy (nCRT']","['laparoscopic- intersphincteric resection or extralevator abdominoperineal excision', 'laparoscopic intersphincteric resection group or L-ELAPE', 'Standard radical laparoscopic surgeries', 'laparoscopic intersphincteric resection (ISR) and extralevator abdominoperineal resection (ELAPE']","['scores of QoL questionnaire-core 30, QoL questionnaire-colorectum 29, Wexner incontinence score, International Prostate Symptom Score (for male), International Index of Erectile Function-5', 'postoperative QoL and efficacy', 'incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes', 'postoperative quality of life (QoL) and survival outcomes']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.149055,"The secondary outcomes consist of incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes.
","[{'ForeName': 'Wenming', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, West China-Shangjin Hospital of Sichuan University/Chengdu Shangjin Nanfu Hospital, No. 253 Shangjin Road, Chengdu, China.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital of Sichuan University, No. 37 Guoxue Lane, Chengdu.'}, {'ForeName': 'Cun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Yongyang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Zongguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}]",Medicine,['10.1097/MD.0000000000020245']
3269,32475277,Using pharmacogenetics to structure individual pain management protocols in total knee arthroplasty.,"AIMS
The purpose of this study was to use pharmacogenetics to determine the frequency of genetic variants in our total knee arthroplasty (TKA) patients that could affect postoperative pain medications. Pharmacogenetic testing evaluates patient DNA to determine if a drug is expected to have a normal clinical effect, heightened effect, or no effect at all on the patient. It also predicts whether patients are likely to experience side effects from medicine. We further sought to determine if changing the multimodal programme based on these results would improve pain control or reduce side effects.
METHODS
In this pilot study, buccal samples were collected from 31 primary TKA patients. Pharmacogenetics testing examined genetic variants in genes OPRM1 , CYP1A2 , CYP2B6 , CYP2C19 , CYP3A4 , CYP2C9 , and CYP2D6 . These genes affect the pharmacodynamics and pharmacokinetics of non-steroidal anti-inflammatory drugs and opioids. We examined the frequency of genetic variants to any of the medications we prescribed including celecoxib, hydrocodone, and tramadol. Patients were randomized to one of two groups: the control group received the standard postoperative pain regimen, and the study group received a customized regimen based on the pharmacogenetic results. For the first ten postoperative days, patients recorded pain scores, medication, and side effects.
RESULTS
Genetic variants involving one or more medications in the multimodal pain protocol occurred in 13 of the 31 patients (42%). In total, eight patients (26%) had variants affecting more than one of the medications. For the 25 patients who recorded pain and medication logs, the mean pain levels and morphine equivalents (MEQs) consumed in the first ten days were higher in the control group than in the custom-guided group (p = 0.019 for pain and p = 0.655 for MEQ).
CONCLUSION
Overall, 42% of patients had a variant involving one of the pain medications prescribed in our perioperative pain program for TKA. Ongoing research will help determine if using these data to modify a patient's medication will improve outcomes. Cite this article: Bone Joint J 2020;102-B(6 Supple A):73-78.",2020,"Patients were randomized to one of two groups: the control group received the standard postoperative pain regimen, and the study group received a customized regimen based on the pharmacogenetic results.","['total knee arthroplasty', 'total knee arthroplasty (TKA) patients', '31 primary TKA patients']","['standard postoperative pain regimen', 'celecoxib, hydrocodone, and tramadol']","['postoperative pain medications', 'pain scores, medication, and side effects', 'multimodal pain protocol', 'mean pain levels and morphine equivalents (MEQs']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",8.0,0.0321511,"Patients were randomized to one of two groups: the control group received the standard postoperative pain regimen, and the study group received a customized regimen based on the pharmacogenetic results.","[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Hamilton', 'Affiliation': 'Anderson Orthopaedic Research Institute, Alexandria, Virginia, USA.'}, {'ForeName': 'Jeanine M', 'Initials': 'JM', 'LastName': 'Gargiulo', 'Affiliation': 'Anderson Orthopaedic Research Institute, Alexandria, Virginia, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Parks', 'Affiliation': 'Anderson Orthopaedic Research Institute, Alexandria, Virginia, USA.'}]",The bone & joint journal,['10.1302/0301-620X.102B6.BJJ-2019-1539.R1']
3270,32475278,2020 Mark Coventry Award: Microorganism-directed oral antibiotics reduce the rate of failure due to further infection after two-stage revision hip or knee arthroplasty for chronic infection: a multicentre randomized controlled trial at a minimum of two years.,"AIMS
The aim of this study was to determine if a three-month course of microorganism-directed oral antibiotics reduces the rate of failure due to further infection following two-stage revision for chronic prosthetic joint infection (PJI) of the hip and knee.
METHODS
A total of 185 patients undergoing a two-stage revision in seven different centres were prospectively enrolled. Of these patients, 93 were randomized to receive microorganism-directed oral antibiotics for three months following reimplantation; 88 were randomized to receive no antibiotics, and four were withdrawn before randomization. Of the 181 randomized patients, 28 were lost to follow-up, six died before two years follow-up, and five with culture negative infections were excluded. The remaining 142 patients were followed for a mean of 3.3 years (2.0 to 7.6) with failure due to a further infection as the primary endpoint. Patients who were treated with antibiotics were also assessed for their adherence to the medication regime and for side effects to antibiotics.
RESULTS
Nine of 72 patients (12.5%) who received antibiotics failed due to further infection compared with 20 of 70 patients (28.6%) who did not receive antibiotics (p = 0.012). Five patients (6.9%) in the treatment group experienced adverse effects related to the administered antibiotics severe enough to warrant discontinuation.
CONCLUSION
This multicentre randomized controlled trial showed that a three-month course of microorganism-directed, oral antibiotics significantly reduced the rate of failure due to further infection following a two-stage revision of total hip or knee arthroplasty for chronic PJI. Cite this article: Bone Joint J 2020;102-B(6 Supple A):3-9.",2020,"RESULTS
Nine of 72 patients (12.5%) who received antibiotics failed due to further infection compared with 20 of 70 patients (28.6%) who did not receive antibiotics (p = 0.012).","['185 patients undergoing a two-stage revision in seven different centres were prospectively enrolled', 'two-stage revision for chronic prosthetic joint infection (PJI) of the hip and knee', '181 randomized patients, 28 were lost to follow-up, six died before two years follow-up, and five with culture negative infections were excluded', '2020 Mark Coventry Award', 'The remaining 142 patients were followed for a mean of 3.3 years (2.0 to 7.6) with failure due to a further infection as the primary endpoint']","['no antibiotics', 'microorganism-directed, oral antibiotics', 'Microorganism-directed oral antibiotics', 'microorganism-directed oral antibiotics']","['adverse effects', 'rate of failure', 'antibiotics failed due to further infection']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439619', 'cui_str': 'Two stage revision'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0410808', 'cui_str': 'Prosthetic joint infection'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0855652', 'cui_str': 'Culture negative'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",185.0,0.130337,"RESULTS
Nine of 72 patients (12.5%) who received antibiotics failed due to further infection compared with 20 of 70 patients (28.6%) who did not receive antibiotics (p = 0.012).","[{'ForeName': 'JaeWon', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Parvizi', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Erik N', 'Initials': 'EN', 'LastName': 'Hansen', 'Affiliation': 'Department of Orthopaedic Surgery, University of California San Francisco Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Culvern', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Segreti', 'Affiliation': 'Department of Internal Medicine, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Curtis W', 'Initials': 'CW', 'LastName': 'Hartman', 'Affiliation': 'Department of Orthopaedic Surgery, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Sporer', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Division of Adult Reconstruction, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The bone & joint journal,['10.1302/0301-620X.102B6.BJJ-2019-1596.R1']
3271,32475294,Sixth-year follow-up of the effects of recreational activities found to eliminate the symptoms of social phobia and shyness.,"BACKGROUND
The lack of 6-year follow-up studies that test the effect of recreational activities in the recovery of social phobia and shyness symptoms is the reason to conduct this study.
AIM
The purpose is to follow the effect of the 12-week recreational activity program found to eliminate social phobia and shyness symptoms after the completion of university studies in its sixth year.
METHODS
At the end of the 12-week recreational activity program that treats the symptoms of social phobia and shyness in university prep school students, 83 students who participated in the posttest both from intervention and control groups were invited to the study. In the sixth-year follow-up study, a total of 51 voluntary students - 32 from the intervention group and 19 from the control group - were administered the Liebowitz Social Anxiety Scale, the Shyness Scale and the Coopersmith Self-Esteem Inventory.
RESULTS
When the pretests and the sixth-year scores are compared, it is seen that it still has an improving effect on social phobia and shyness; when the posttests and the sixth-year tests are compared, no difference is seen regarding social phobia whereas it is seen that recovery still continues regarding the symptoms of shyness, and a decrease is seen in self-esteem.
DISCUSSION
While the improving effect of recreational activities on shyness and social phobia symptoms still continues, their effect on self-esteem decreases.
CONCLUSION
It is suggested that recreational activities should be included in the programs at universities regarding personal and professional development, and the reasons for the decrease in self-esteem scores should be determined through more detailed studies.",2020,"When the pretests and the sixth-year scores are compared, it is seen that it still has an improving effect on social phobia and shyness; when the posttests and the sixth-year tests are compared, no difference is seen regarding social phobia whereas it is seen that recovery still continues regarding the symptoms of shyness, and a decrease is seen in self-esteem.
","['university prep school students, 83 students who participated in the posttest both from intervention and control groups were invited to the study']","['recreational activities', 'recreational activity program']","['Liebowitz Social Anxiety Scale', 'social phobia and shyness symptoms']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0037020', 'cui_str': 'Shyness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",83.0,0.0164186,"When the pretests and the sixth-year scores are compared, it is seen that it still has an improving effect on social phobia and shyness; when the posttests and the sixth-year tests are compared, no difference is seen regarding social phobia whereas it is seen that recovery still continues regarding the symptoms of shyness, and a decrease is seen in self-esteem.
","[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Karagün', 'Affiliation': 'Faculty of Sports Science, Department of Recreation, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yildiz', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Çiğdem', 'Initials': 'Ç', 'LastName': 'Çağlayan', 'Affiliation': 'Faculty of Medicine, Department of Public Health, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Zekiye', 'Initials': 'Z', 'LastName': 'Başaran', 'Affiliation': 'Faculty of Sports Sciences, Kocaeli University, Kocaeli, Turkey.'}]",The International journal of social psychiatry,['10.1177/0020764020924702']
3272,32475312,"Modest Sodium Reduction Increases Circulating Short-Chain Fatty Acids in Untreated Hypertensives: A Randomized, Double-Blind, Placebo-Controlled Trial.","High-sodium diet may modulate the gut microbiome. Given the circulating short-chain fatty acids (SCFAs) are microbial in origin, we tested the hypothesis that the modest sodium reduction would alter circulating SCFA concentrations among untreated hypertensives, and the changes would be associated with reduced blood pressure and improved cardiovascular phenotypes. A total of 145 participants (42% blacks, 19% Asian, and 34% females) were included from a randomized, double-blind, placebo-controlled cross-over trial of sodium reduction with slow sodium or placebo tablets, each for 6 weeks. Targeted circulating SCFA profiling was performed in paired serum samples, which were collected at the end of each period, so as all outcome measures. Sodium reduction increased all 8 SCFAs, among which the increases in 2-methylbutyrate, butyrate, hexanoate, isobutyrate, and valerate were statistically significant ( P s<0.05). Also, increased SCFAs were associated with decreased blood pressure and improved arterial compliance. There were significant sex differences of SCFAs in response to sodium reduction ( P s<0.05). When stratified by sex, the increases in butyrate, hexanoate, isobutyrate, isovalerate, and valerate were significant in females only ( P s<0.05), not in males ( P s>0.05). In females, changes in isobutyrate, isovalerate, and 2-methylbutyrate were inversely associated with reduced blood pressures ( P s<0.05). Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040). Our results show that dietary sodium reduction increases circulating SCFAs, supporting that dietary sodium may influence the gut microbiome in humans. There is a sex difference in SCFA response to sodium reduction. Moreover, increased SCFAs are associated with decreased blood pressures and improved arterial compliance. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00152074.",2020,Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040).,"['145 participants (42% blacks, 19% Asian, and 34% females', 'Untreated Hypertensives']","['placebo-controlled cross-over trial of sodium reduction with slow sodium or placebo tablets', 'Modest Sodium Reduction Increases Circulating Short-Chain Fatty Acids', 'Placebo', 'High-sodium diet']","['blood pressures and improved arterial compliance', 'Sodium reduction', 'SCFA response', 'blood pressures', '2-methylbutyrate, butyrate, hexanoate, isobutyrate, and valerate', 'circulating SCFA concentrations', 'blood pressure and improved cardiovascular phenotypes', 'carotid-femoral pulse wave velocity', 'blood pressure and improved arterial compliance', 'butyrate, hexanoate, isobutyrate, isovalerate, and valerate']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0452340', 'cui_str': 'High sodium diet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0046367', 'cui_str': '2-methylbutyrate'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0121652', 'cui_str': 'hexanoate'}, {'cui': 'C0042280', 'cui_str': 'Pentanoates'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",145.0,0.135264,Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom (F.J.H., C.W.).'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Changqiong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom (F.J.H., C.W.).'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Harshfield', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14800']
3273,32475359,"Glucose control upon waking is unaffected by hourly sleep fragmentation during the night, but is impaired by morning caffeinated coffee.","Morning coffee is a common remedy following disrupted sleep yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults. Remarkably, the combined effects of sleep fragmentation and coffee on glucose control upon waking per se have never been investigated.In a randomised cross-over design, 29 adults (Mean ± SD; age: 21 ± 1 years, BMI: 24.4 ± 3.3 kg·m-2) underwent three oral glucose tolerance tests (OGTT). One following a habitual night of sleep (Control; in bed, lights-off trying to sleep ~2300-0700 h) the others following a night of sleep fragmentation (as Control but waking hourly for 5 min), once with and once without morning coffee ~1 h after waking (~300 mg caffeine as black coffee 30 min prior to OGTT).Peak plasma glucose and insulin concentrations were unaffected by sleep quality but were higher following coffee consumption (Mean [normalised confidence interval] for Control, Fragmented, and Fragmented+Coffee, respectively; Glucose: 8.20 [7.93-8.47] mmol∙L-1versus 8.23 [7.96-8.50] mmol∙L-1versus 8.96 [8.70-9.22] mmol.L-1; Insulin: 265 [247-283] pmol∙L-1; and 235 [218-253] pmol∙L-1; and 310 [284-337] pmol∙L-1). Likewise, iAUC for plasma glucose was higher in the Fragmented+Coffee trial compared to Fragmented.Whilst sleep fragmentation did not alter glycaemic or insulinaemic responses to morning glucose ingestion, if a strong caffeinated coffee is consumed then a reduction in glucose tolerance can be expected.",2020,Morning coffee is a common remedy following disrupted sleep yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults.,"['healthy adults', '29 adults (Mean ± SD; age: 21 ± 1 years, BMI: 24.4 ± 3.3 kg·m-2) underwent three']","['habitual night of sleep (Control; in bed, lights-off trying to sleep ~2300-0700 h) the others following a night of sleep fragmentation', 'oral glucose tolerance tests (OGTT', 'Fragmented+Coffee']","['glucose tolerance', 'Likewise, iAUC for plasma glucose']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517688', 'cui_str': '3.3'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",29.0,0.0411912,Morning coffee is a common remedy following disrupted sleep yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults.,"[{'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Smith', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Heath', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Perkin', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, United Kingdom.'}]",The British journal of nutrition,['10.1017/S0007114520001865']
3274,32475360,"Vitamin D 3 reduces risk of cardiovascular and liver diseases by lowering homocysteine levels: double-blinded, randomized, placebo-controlled trial.","The objective of this study was to evaluate the effect of vitamin D3 on total homocysteine (tHcy) and C-reactive protein (CRP) levels and liver and kidney function tests in overweight women with vitamin D deficiency. Therefore, a randomized double-blind placebo controlled clinical trial was conducted on one hundred eligible women. Subjects were randomly divided into two groups: the placebo (n = 50) and the vitamin D (n = 50) which received 50,000 IU vitamin D3 per week for 2 months. The participants' 25- hydroxyvitamin D (25 (OH)D), tHcy, CRP, aspartate and alanine aminotransferases (AST, ALT), urea, creatinine and estimated glomerular filtration rate (eGFR) were measured and compared before and after treatment. Results showed that the tHcy, CRP, AST, ALT, and eGFR levels after the second month of vitamin D3 intervention were significantly (p < 0.001) decreased and the 25(OH)D, urea, and creatinine levels were significantly (p < 0.001) increased in the treatment group. In the placebo group, no significant changes were identified throughout the follow up period. In conclusion, vitamin D3 intervention with a treatment dose of 50,000 IU per week for at least 2 months may help in lowering homocysteine and CRP levels and may improve liver function tests, which in turn might help in minimizing the risk of CVD and liver diseases among overweight women but negatively affect kidney function.",2020,"Results showed that the tHcy, CRP, AST, ALT, and eGFR levels after the second month of vitamin D3 intervention were significantly (p < 0.001) decreased and the 25(OH)D, urea, and creatinine levels were significantly (p < 0.001) increased in the treatment group.","['overweight women with vitamin D deficiency', 'one hundred eligible women']","['Vitamin D', 'placebo', 'vitamin D3 intervention', 'vitamin D', 'vitamin D3', '50,000 IU vitamin D3']","['tHcy, CRP, AST, ALT, and eGFR levels', 'risk of cardiovascular and liver diseases', '25(OH)D, urea, and creatinine levels', 'total homocysteine (tHcy) and C-reactive protein (CRP) levels and liver and kidney function tests', 'lowering homocysteine and CRP levels', '25- hydroxyvitamin D (25 (OH)D), tHcy, CRP, aspartate and alanine aminotransferases (AST, ALT), urea, creatinine and estimated glomerular filtration rate (eGFR', 'liver function tests']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}]",100.0,0.469588,"Results showed that the tHcy, CRP, AST, ALT, and eGFR levels after the second month of vitamin D3 intervention were significantly (p < 0.001) decreased and the 25(OH)D, urea, and creatinine levels were significantly (p < 0.001) increased in the treatment group.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Al-Bayyari', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Al-Huson University College, Al-Balqa Applied University, Al-Salt, Jordan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hailat', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Subih', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Alkhalidy', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eaton', 'Affiliation': 'Department of Integrated Physiology and Health Sciences, Alma College, Alma, Michigan, USA.'}]",The British journal of nutrition,['10.1017/S0007114520001890']
3275,32475989,A randomized placebo-controlled PET study of ketamine´s effect on serotonin 1B receptor binding in patients with SSRI-resistant depression.,"The glutamate N-methyl-D-aspartate receptor antagonist ketamine has a rapid antidepressant effect. Despite large research efforts, ketamine's mechanism of action in major depressive disorder (MDD) has still not been determined. In rodents, the antidepressant properties of ketamine were found to be dependent on both the α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) and the serotonin (5-HT) 1B receptor. Low 5-HT 1B receptor binding in limbic brain regions is a replicated finding in MDD. In non-human primates, AMPA-dependent increase in 5-HT 1B receptor binding in the ventral striatum (VST) has been demonstrated after ketamine infusion. Thirty selective serotonin reuptake inhibitor-resistant MDD patients were recruited via advertisement and randomized to double-blind monotherapy with 0.5 mg/kg ketamine or placebo infusion. The patients were examined with the 5-HT 1B receptor selective radioligand [ 11 C]AZ10419369 and positron emission tomography (PET) before and 24-72 h after treatment. 5-HT 1B receptor binding did not significantly alter in patients treated with ketamine compared with placebo. An increase in 5-HT 1B receptor binding with 16.7 % (p = 0.036) was found in the hippocampus after one ketamine treatment. 5-HT 1B receptor binding in VST at baseline correlated with MDD symptom ratings (r = -0.426, p = 0.019) and with reduction of depressive symptoms with ketamine (r = -0.644, p = 0.002). In conclusion, reduction of depressive symptoms in MDD patients after ketamine treatment is correlated inversely with baseline 5-HT 1B receptor binding in VST. Further studies examining the role of 5-HT 1B receptors in the antidepressant mechanism of action of ketamine should be conducted, homing in on the 5-HT 1B receptor as an MDD treatment response marker.",2020,An increase in 5-HT 1B receptor binding with 16.7 % (p = 0.036) was found in the hippocampus after one ketamine treatment.,"['Thirty selective serotonin reuptake inhibitor-resistant MDD patients', 'patients with SSRI-resistant depression']","['glutamate N-methyl-D-aspartate receptor antagonist ketamine', 'ketamine', 'ketamine or placebo infusion', 'placebo']","['MDD symptom ratings', 'depressive symptoms', '5-HT 1B receptor binding']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C0535025', 'cui_str': '5-HT1B Receptor'}]",30.0,0.0756628,An increase in 5-HT 1B receptor binding with 16.7 % (p = 0.036) was found in the hippocampus after one ketamine treatment.,"[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Tiger', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden. mikael.tiger@ki.se.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Veldman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Ekman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Halldin', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Svenningsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lundberg', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}]",Translational psychiatry,['10.1038/s41398-020-0844-4']
3276,32476054,Acute exercise-related cognitive effects are not attributable to changes in end-tidal CO 2 or cerebral blood velocity.,"PURPOSE
Cognition, cerebral blood flow (CBF) and its major regulator (i.e., arterial CO 2 ), increase with submaximal exercise and decline with severe exercise. These responses may depend on fitness. We investigated whether exercise-related changes in cognition are mediated in part by concomitant changes in CBF and CO 2 , in ten active (26 ± 3 years) and ten inactive (24 ± 6 years) healthy adults.
METHODS
Participants completed two randomised sessions; exercise and a resting CO 2 -control-wherein end-tidal CO 2 (PETCO 2 ) was matched between sessions and clamped across conditions at exercise-associated increases (+ 3 mmHg) and hypercapnia (+ 10 mmHg). Exercise comprised inclined walking at submaximal and severe intensities. CBF was indexed using right middle cerebral artery blood velocity (MCAv). Cognition (visuomotor, switching and inhibitory response time) was measured before, during, and after exercise.
RESULTS
MCAv and its inverted-U response to exercise were comparable between groups, whereas visuomotor performance improved during submaximal exercise in the active group only (p = 0.046). Submaximal, but not severe (p = 0.33), exercise increased MCAv (p ≤ 0.03). Hypercapnia increased MCAv during the CO 2 -control (27 ± 12%) and during submaximal exercise (39 ± 17%; p < 0.01). Despite the acute increases in MCAv, cognition was impaired during both levels of increased PETCO 2 (3-6%; p ≤ 0.04), regardless of session. Overall, resting or exercise-related changes in PETCO 2 and MCAv did not associate with changes in cognition (r ≤ 0.29 ± 0.34). Fitness ([Formula: see text]O 2MAX ) was associated with baseline cognition (r ≥ 0.50).
CONCLUSION
Acute increases in PETCO 2 and MCAv were not associated with improved cognition. In fact, cognitive performance was impaired at both levels of increased PETCO 2 , regardless of session. Finally, fitter people were found to have better cognition.",2020,"Submaximal, but not severe (p = 0.33), exercise increased MCAv (p ≤ 0.03).","['ten active (26\u2009±\u20093\xa0years) and ten inactive (24\u2009±\u20096\xa0years) healthy adults', 'Participants completed two randomised']",['sessions; exercise and a resting CO 2 -control-wherein end-tidal CO 2 (PETCO 2 ) was matched between sessions and clamped across conditions at exercise-associated increases (+\u20093\xa0mmHg) and hypercapnia (+\u200910\xa0mmHg'],"['cognitive performance', 'MCAv, cognition', 'Cognition (visuomotor, switching and inhibitory response time', 'right middle cerebral artery blood velocity (MCAv', 'Hypercapnia increased MCAv', 'visuomotor performance', 'Overall, resting or exercise-related changes in PETCO 2 and MCAv', 'exercise increased MCAv', 'Cognition, cerebral blood flow (CBF']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0226213', 'cui_str': 'Structure of right middle cerebral artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",,0.0414652,"Submaximal, but not severe (p = 0.33), exercise increased MCAv (p ≤ 0.03).","[{'ForeName': 'Leena N', 'Initials': 'LN', 'LastName': 'Shoemaker', 'Affiliation': 'School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. Luke.wilson@otago.ac.nz.'}, {'ForeName': 'Samuel J E', 'Initials': 'SJE', 'LastName': 'Lucas', 'Affiliation': 'Department of Physiology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Machado', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Cotter', 'Affiliation': 'School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand.'}]",European journal of applied physiology,['10.1007/s00421-020-04393-7']
3277,32476057,The impact of employment on recovery among individuals who are homeless with severe mental illness in the Vancouver At Home/Chez Soi trial.,"OBJECTIVE
To assess impact of employment on recovery in a sample of adults from Vancouver At Home (VAH) study, who were homeless and were diagnosed with severe mental disorders.
METHODS
The VAH included two randomized controlled trials investigating the effect of housing first with support intervention in vulnerable population. Employment was assessed at baseline and during the follow-up using Demographics, Housing, Vocational, and Service Use History (DSHH), and Vocational Timeline Follow-Back (VTLFB) self-report questionnaires, respectively. Recovery was examined using Recovery Assessment Scale (RAS) at baseline and at 24-month follow-up visit. Multivariable regression models were built to examine: (1) the effect of current employment at baseline on RAS score at baseline, and RAS score at 24-month follow-up visit; and (2) and to examine the cumulative effect of recent employment over 8 follow-up visits on RAS score at 24-month visit. Cumulative effect of employment over the follow-up visits was weighted by recency using a pre-specified weighting function.
RESULTS
Employment at baseline was associated with an increase in recovery score at baseline [8.06 (95% CI 1.21, 14.91); p = 0.02], but not with recovery score at 24-month follow-up visit [3.78 (-4.67, 12.24); p = 0.37]. Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
CONCLUSION
Employment is associated with an increase in recovery. Our result suggests a dual effect of employment on recovery, an immediate effect through current employment, and a long-term effect of cumulative employment.",2020,"Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
","['sample of adults from Vancouver At Home (VAH) study, who were homeless and were diagnosed with severe mental disorders', 'individuals who are homeless with severe mental illness in the Vancouver', 'vulnerable population']",['housing first with support intervention'],"['recovery score', 'recovery', 'RAS score at baseline, and RAS score', 'Demographics, Housing, Vocational, and Service Use History (DSHH), and Vocational Timeline Follow-Back (VTLFB) self-report questionnaires', 'Recovery Assessment Scale (RAS', 'RAS score']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.178522,"Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
","[{'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Yazdani', 'Affiliation': 'Addiction and Concurrent Disorders Group, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada. kia_yzd@yahoo.com.'}, {'ForeName': 'Mohammadali', 'Initials': 'M', 'LastName': 'Nikoo', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Sayre', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Choi', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Jang', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Reinhard Michael', 'Initials': 'RM', 'LastName': 'Krausz', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-020-01887-9']
3278,32476089,Simple oral exercise with chewing gum for improving oral function in older adults.,"BACKGROUND
As general and oral health are closely interrelated, promoting oral health may extend a healthy life expectancy.
AIMS
To evaluate the long-term effects of simple oral exercise (SOE) and chewing gum exercise on mastication, salivation, and swallowing function in adults aged ≥ 65 years.
METHODS
Ninety-six participants were assigned to control, SOE, and GOE (chewing gum exercise with SOE) groups. The SOE comprised exercises to improve mastication, salivation, and swallowing function. Control group participants performed no exercises. The intervention period was 8 weeks, followed by a 3-week maintenance period. The Mixing Ability Index (MAI), occlusal force, unstimulated saliva, and repetitive saliva swallowing test were evaluated at baseline and 2, 5, 8, and 11 weeks later. Self-reported discomfort was re-evaluated after 8 weeks.
RESULTS
After 8 weeks, mean MAI differences from baseline significantly increased in both groups; the increase in the GOE group was largest and four times higher than in the control group. Mean differences of occlusal force from baseline increased by 56 N (SOE group) and 60 N (GOE group). The increase of salivation was greater in the SOE (3.6-fold) and GOE (2.2-fold) groups than in the control group. Furthermore, 27% and 18% of SOE and GOE group participants, respectively, were re-categorized as having good swallowing function. Participants reported less discomfort as oral functions improved.
DISCUSSION
These findings may facilitate the development of clinical practice guidelines for optimal oral care in older adults.
CONCLUSION
While both SOE and GOE may improve oral function in older adults, GOE is recommended for those with impaired mastication.
TRIAL REGISTRATION
KCT0003305, retrospectively registered 31/10/2018.",2020,Mean differences of occlusal force from baseline increased by 56 N (SOE group) and 60 N (GOE group).,"['adults aged ≥', 'Ninety-six participants', 'older adults']","['simple oral exercise (SOE) and chewing gum exercise', 'control, SOE, and GOE (chewing gum exercise with SOE', 'SOE and GOE', 'Simple oral exercise with chewing gum']","['mastication, salivation, and swallowing function', 'oral function', 'discomfort as oral functions improved', 'Mixing Ability Index (MAI), occlusal force, unstimulated saliva, and repetitive saliva swallowing\xa0test', 'mean MAI differences', 'salivation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",96.0,0.0391626,Mean differences of occlusal force from baseline increased by 56 N (SOE group) and 60 N (GOE group).,"[{'ForeName': 'Hyo-Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Dentistry and Public Oral Health, BK21 PLUS Project, Yonsei University College of Dentistry, 120-752, 50 Yonsei-ro, Seodaemun-Gu, Seoul, Republic of Korea.'}, {'ForeName': 'Joo-Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Dentistry and Public Oral Health, BK21 PLUS Project, Yonsei University College of Dentistry, 120-752, 50 Yonsei-ro, Seodaemun-Gu, Seoul, Republic of Korea.'}, {'ForeName': 'Eun-Song', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Dentistry and Public Oral Health, BK21 PLUS Project, Yonsei University College of Dentistry, 120-752, 50 Yonsei-ro, Seodaemun-Gu, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo-Jung', 'Initials': 'HJ', 'LastName': 'Jung', 'Affiliation': 'Department of Orofacial Pain and Oral Medicine, Yonsei University College of Dentistry, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung-Joon', 'Initials': 'HJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Orofacial Pain and Oral Medicine, Yonsei University College of Dentistry, Seoul, Republic of Korea.'}, {'ForeName': 'Hoi In', 'Initials': 'HI', 'LastName': 'Jung', 'Affiliation': 'Department of Preventive Dentistry and Public Oral Health, BK21 PLUS Project, Yonsei University College of Dentistry, 120-752, 50 Yonsei-ro, Seodaemun-Gu, Seoul, Republic of Korea.'}, {'ForeName': 'Baek-Il', 'Initials': 'BI', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Dentistry and Public Oral Health, BK21 PLUS Project, Yonsei University College of Dentistry, 120-752, 50 Yonsei-ro, Seodaemun-Gu, Seoul, Republic of Korea. drkbi@yuhs.ac.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01606-z']
3279,32476255,Effects of DPP-4 inhibitor linagliptin versus sulfonylurea glimepiride on systemic haemodynamics in overweight patient with type 2 diabetes: a secondary analysis of an 8-week randomized controlled double-blind trial.,"AIMS
To determine the glucose-independent effect of the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin versus the sulfonylurea glimepiride on systemic hemodynamics in the fasting and postprandial state in patients with type 2 diabetes mellitus (T2DM).
MATERIALS AND METHODS
In this pre-specified secondary analysis of a phase-IV, double-blind trial, 46 metformin-treated, overweight T2DM patients were included and randomly assigned (1:1) to once-daily linagliptin (5mg) or glimepiride (1mg) for 8 weeks. In a sub-study involving 26 patients, systemic hemodynamics were also assessed following a standardized liquid meal (Nutridrink Yoghurt style). Systemic haemodynamic (oscillometric device and finger photoplethysmography), arterial stiffness (applanation tonometry), and cardiac sympathovagal balance (heart rate variability; HRV) were measured in the fasting state and repetitively following the meal. Ewing-tests were performed in the fasting state.
RESULTS
From baseline to Week-8, linagliptin compared to glimepiride did not affect systemic hemodynamics, arterial stiffness or HRV in the fasting state. Linagliptin increased parasympathetic nervous activity, as measured by the Valsalva-manoeuvre (p=0.021) and deep-breathing-test (p=0.027), when compared to glimepiride. Postprandially, SBP dropped an average of 7.6±1.6 mmHg. Linagliptin reduced this decrease to 0.7±2.3 mmHg, which was significant to glimepiride (p=0.010).
CONCLUSIONS
When compared with glimepiride, linagliptin does not affect fasting blood pressure. However, linagliptin blunted the postprandial drop in systolic BP, which could benefit patients with postprandial hypotension. This article is protected by copyright. All rights reserved.",2020,"RESULTS
From baseline to Week-8, linagliptin compared to glimepiride did not affect systemic hemodynamics, arterial stiffness or HRV in the fasting state.","['46 metformin-treated, overweight T2DM patients', 'overweight patient with type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM']","['Linagliptin', 'glimepiride, linagliptin', 'sulfonylurea glimepiride', 'dipeptidyl peptidase (DPP)-4 inhibitor linagliptin', 'glimepiride', 'DPP-4 inhibitor linagliptin', 'linagliptin']","['systemic hemodynamics, arterial stiffness or HRV', 'systemic hemodynamics', 'fasting blood pressure', 'parasympathetic nervous activity', 'Systemic haemodynamic (oscillometric device and finger photoplethysmography), arterial stiffness (applanation tonometry), and cardiac sympathovagal balance (heart rate variability; HRV', 'Valsalva-manoeuvre', 'systemic haemodynamics']","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0012515', 'cui_str': 'Dipeptidylpeptide hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042293', 'cui_str': 'Valsalva maneuver'}]",26.0,0.102531,"RESULTS
From baseline to Week-8, linagliptin compared to glimepiride did not affect systemic hemodynamics, arterial stiffness or HRV in the fasting state.","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Kraaijenhof', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'D Margriet', 'Initials': 'DM', 'LastName': 'Ouwens', 'Affiliation': 'German Diabetes Center (DDZ), Leibniz Center for Diabetes Research, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14107']
3280,32476277,A comparative study of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderate to severe active rheumatoid arthritis: A subgroup analysis.,"AIM
PF-06438179/GP1111 (PF-SZ-IFX) is a biosimilar of reference infliximab (Remicade ® ). This analysis compared the efficacy of PF-SZ-IFX and reference infliximab sourced from the European Union (IFX-EU) in patient subgroups from a randomized, comparative study of PF-SZ-IFX versus IFX-EU.
METHODS
Patients with rheumatoid arthritis were randomized 1:1 to PF-SZ-IFX (n = 324) or IFX-EU (n = 326); study drug (3 mg/kg) was administered intravenously at weeks 0, 2, and 6, then every 8 weeks thereafter. Subgroup analyses of efficacy endpoints such as American College of Rheumatology criteria for ≥20% clinical improvement (ACR20), change in high-sensitivity C-reactive protein (hs-CRP), and change in Disease Activity Score in 28 joints, four components based on hs-CRP (DAS28-CRP) at weeks 14 and 30 were performed by age, gender, race, region, immunogenicity status, and treatment history.
RESULTS
Overall, ACR20 response rates as well as changes in DAS28-CRP and hs-CRP at week 14 were similar between PF-SZ-IFX and IFX-EU within the subgroups of age, gender, race, region, treatment history, and immunogenicity status. Results to week 30 support overall similarity in efficacy between the two treatment arms in all subgroups.
CONCLUSION
Overall, PF-SZ-IFX and IFX-EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status. The efficacy results from these subgroup analyses were aligned with the previously described results for the overall population up to week 30.",2020,"Overall, PF-SZ-IFX and IFX-EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status.","['patients with moderate to severe active rheumatoid arthritis', 'n\xa0=\xa0326', 'Patients with rheumatoid arthritis']","['IFX-EU', 'PF-SZ-IFX and reference infliximab', 'PF-06438179/GP1111', 'PF-06438179/GP1111 (PF-SZ-IFX', 'infliximab', 'PF-SZ-IFX']","['American College of Rheumatology criteria for ≥20% clinical improvement (ACR20), change in high-sensitivity C-reactive protein (hs-CRP), and change in Disease Activity Score', 'Overall, ACR20 response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0550322,"Overall, PF-SZ-IFX and IFX-EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status.","[{'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Uechi', 'Affiliation': 'Division of Rheumatology, Tomishiro Central Hospital, Okinawa, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Abud-Mendoza', 'Affiliation': 'Rheumatology Research Unit, Faculty of Medicine, Central Hospital Dr. Ignacio Morones Prieto, Universidad Autónoma de San Luis Potosí, San Luis, Mexico.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Kamei', 'Affiliation': 'Inflammation and Immunology Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.'}, {'ForeName': 'Tsugumi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Inflammation and Immunology Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Ponce de Leon', 'Affiliation': 'Inflammation and Immunology, Latin America Medical Affairs, Pfizer Inc, Lima, Peru.'}, {'ForeName': 'Muhammad I', 'Initials': 'MI', 'LastName': 'Rehman', 'Affiliation': 'Clinical Development, Pfizer Inc, Andover, MA, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Global Biometrics and Data Management, Pfizer Inc, La Jolla, CA, USA.'}, {'ForeName': 'Sebastiao C', 'Initials': 'SC', 'LastName': 'Radominski', 'Affiliation': 'Rheumatology Service, Clinical Hospital, Universidade Federal do Paraná, Curitiba, Brazil.'}]",International journal of rheumatic diseases,['10.1111/1756-185X.13846']
3281,32476445,Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial.,"OBJECTIVE
To compare the efficacy and safety of costal chondrocyte-derived pellet-type autologous chondrocyte implantation (CCP-ACI) with microfracture (MFx) for repair of articular cartilage defects of the knee.
DESIGN
Thirty subjects with an International Cartilage Repair Society (ICRS) grade 3 to 4 chondral defect (2-10 cm 2 in area; ≤4 cm 3 in volume) were randomized at a ratio of 2:1 (CCP-ACI:MFx). Twenty patients were allocated in the CCP-ACI group and 10 patients in the MFx group. CCP-ACI was performed by harvesting costal cartilage at least 4 weeks before surgery. Implantation was performed without any marrow stimulation. Efficacy and safety were assessed at weeks 8, 24, and 48 after surgery according to the magnetic resonance observation of cartilage repair tissue (MOCART) score and clinical outcomes.
RESULTS
MOCART scores improved from baseline to 24 and 48 weeks postoperatively in both treatment groups. The improvement in MOCART scores in the CCP-ACI group was significantly greater than that in the MFx group at 24 and 48 weeks (39.1 vs 21.8 and 43.0 vs 24.8, respectively). The proportions of complete defect repair and complete integration were significantly higher in the CCP-ACI group than the MFx group at 48 weeks. Improvement in Lysholm score and KOOS subscores, including Function (Sports and Recreational Activity) and knee-related quality of life was significantly greater in the CCP-ACI group than the MFx group at 48 weeks (35.4 vs 31.5, 35.7 vs 28.5, and 27.9 vs 11.6, respectively).
CONCLUSION
Treatment of cartilage defects with CCP-ACI yielded satisfactory cartilage tissue repair outcomes, with good structural integration with native cartilage tissue shown by magnetic resonance imaging at 24 and 48 weeks after surgery.
LEVEL OF EVIDENCE
Level 1: Randomized controlled study.",2020,"Improvement in Lysholm score and KOOS subscores, including Function (Sports and Recreational Activity) and knee-related quality of life was significantly greater in the CCP-ACI group than the MFx group at 48 weeks (35.4 vs 31.5, 35.7 vs 28.5, and 27.9 vs 11.6, respectively).
","['group and 10 patients in the MFx group', 'Repair of Articular Cartilage Defects', 'Thirty subjects with an International Cartilage Repair Society (ICRS) grade 3 to 4 chondral defect (2-10 cm 2 in area; ≤4 cm 3 in volume', 'Twenty patients']","['Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture', 'costal chondrocyte-derived pellet-type autologous chondrocyte implantation (CCP-ACI) with microfracture (MFx', 'CCP-ACI']","['cartilage repair tissue (MOCART) score and clinical outcomes', 'Lysholm score and KOOS subscores, including Function (Sports and Recreational Activity) and knee-related quality of life', 'Efficacy and safety', 'efficacy and safety', 'MOCART scores', 'proportions of complete defect repair and complete integration']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0410334', 'cui_str': 'Defect of articular cartilage'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0035561', 'cui_str': 'Bone structure of rib'}, {'cui': 'C0225369', 'cui_str': 'Chondrocyte'}, {'cui': 'C0441436', 'cui_str': 'Pellet gun missile'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C1265651', 'cui_str': 'Microfracture'}]","[{'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",20.0,0.117533,"Improvement in Lysholm score and KOOS subscores, including Function (Sports and Recreational Activity) and knee-related quality of life was significantly greater in the CCP-ACI group than the MFx group at 48 weeks (35.4 vs 31.5, 35.7 vs 28.5, and 27.9 vs 11.6, respectively).
","[{'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': 'Department of Orthopaedic Surgery, Kyung-Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Doo', 'Initials': 'JD', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Chong-Hyuk', 'Initials': 'CH', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Yonsei University, Gangnam Severance Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jungsun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'R&D Institute, Biosolution Co., Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'R&D Institute, Biosolution Co., Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Gyun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University College of Medicine, Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Kyung-Hee University Hospital, Seoul, Republic of Korea.'}]",Cartilage,['10.1177/1947603520921448']
3282,32476640,"Effects of the Rango Cards game intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices of high school students: a cluster randomised controlled trial.","OBJECTIVE
The study aimed to assess the impact of a game-based nutritional intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.
DESIGN
This cluster randomised controlled trial included both male and female high school students from private schools in the Federal District, Brazil. Four schools were randomly selected for each group. Investigated variables were age, sex, monthly family income, maternal education level, dietary perceptions and practices, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.
SETTING
Intervention group participants were instructed to play Rango Cards, a digital game developed for the study, on their own, for a period of 7-17 d, while the control group was not provided with any game or material during the study.
PARTICIPANTS
The study included 319 adolescents (mean age = 15·8 (sd 0·7) years).
RESULTS
Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants. The intervention group showed increased knowledge of the effects of fruit and vegetable consumption as well as improved self-efficacy in the adoption of healthy eating practices such as reducing Na intake and preparing healthy meals.
CONCLUSIONS
The design of Rango Cards is potentially capable of effecting positive changes. Therefore, the digital game promotes autonomy and self-care among adolescents with regard to healthy eating.",2020,"RESULTS
Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants.","['The study included 319 adolescents (mean age = 15·8', 'healthy eating practices', 'adolescents with regard to healthy eating', 'healthy eating practices of high school students', 'male and female high school students from private schools in the Federal District, Brazil']","['play Rango Cards, a digital game', 'game-based nutritional intervention', 'Rango Cards game intervention']","['knowledge of the effects of fruit and vegetable consumption', 'food consumption, nutritional knowledge and self-efficacy', 'self-efficacy']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0567466', 'cui_str': 'Eating practice'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",319.0,0.0509513,"RESULTS
Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants.","[{'ForeName': 'Carolina Martins Dos Santos', 'Initials': 'CMDS', 'LastName': 'Chagas', 'Affiliation': 'Federal University of Lavras, Department of Nutrition,\xa0Minas Gerais37200-000, Brazil.'}, {'ForeName': 'Giselle Rhai-Sa', 'Initials': 'GR', 'LastName': 'Melo', 'Affiliation': 'University of Brasilia, School of Health Sciences, Graduate Program in Human Nutrition, Federal District, Brazil.'}, {'ForeName': 'Raquel Braz Assunção', 'Initials': 'RBA', 'LastName': 'Botelho', 'Affiliation': 'University of Brasilia, School of Health Sciences, Post-Graduate Program in Human Nutrition, Federal District, Brazil.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Toral', 'Affiliation': 'University of Brasilia, School of Health Sciences, Post-Graduate Program in Human Nutrition, Federal District, Brazil.'}]",Public health nutrition,['10.1017/S1368980020000531']
3283,32476659,Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial.,"BACKGROUND
Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov.
OBJECTIVE
This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment.
METHODS
This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery.
RESULTS
This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024.
CONCLUSIONS
This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/15499.",2020,A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions.,"['1140 racially diverse, predominately low-income participants', 'diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care', 'Initial participants began the intervention in October 2019', 'participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care']","['pre-NDPP', 'National Diabetes Prevention Program (NDPP']","['NDPP outcomes', 'NDPP attendance and weight loss', 'NDPP engagement and weight loss', 'doubled attendance and weight loss', 'cost and projected return on investment']","[{'cui': 'C4517539', 'cui_str': '1140'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0021953', 'cui_str': 'Investments'}]",75.0,0.145978,A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions.,"[{'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Ritchie', 'Affiliation': 'Office of Research, Denver Health, Denver, CO, United States.'}, {'ForeName': 'Jodi Summers', 'Initials': 'JS', 'LastName': 'Holtrop', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Gritz', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Katherine Ann', 'Initials': 'KA', 'LastName': 'Sauder', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Michael Josh', 'Initials': 'MJ', 'LastName': 'Durfee', 'Affiliation': 'Office of Research, Denver Health, Denver, CO, United States.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kaufmann', 'Affiliation': 'Villanova University College of Nursing, Philadelphia, PA, United States.'}]",JMIR research protocols,['10.2196/15499']
3284,32476658,Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial-Based Health-Economic Evaluations Embedded in the RECOVER-E Program.,"BACKGROUND
Community-based recovery-oriented mental health services for people with severe mental disorders have not been fully implemented in Bulgaria, Croatia, Macedonia, Montenegro, and Romania. The RECOVER-E project facilitates the implementation of specialized mental health care delivered by setting up services, implementing the services, and evaluating multidisciplinary community mental health teams. The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials.
OBJECTIVE
The aim of this protocol paper is to describe the methodology that will be used for the health-economic evaluation alongside the trials.
METHODS
Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual [CAU]) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia, and other psychotic disorders). The newly implemented health care system will involve community-based recovery-oriented mental health care (CMHC). At each site, 180 consenting patients will be randomized to either CAU or CMHC. Patient-level outcomes are personal and social functioning and quality-adjusted life years (QALYs). Data on participants' health care use will be collected and corresponding health care costs will be computed. This enables evaluation of health care costs of CMHC as compared with CAU, and these costs can be related to patient-level outcomes (functioning and QALY gains) in health-economic evaluation.
RESULTS
Data collection was started in December 2018 (Croatia), February 2019 (Montenegro), April 2019 (Romania), June 2019 (North Macedonia), and October 2019 (Bulgaria). The findings of the outcome evaluations will be reported for each of the five countries separately, and the five trials will be pooled for multilevel analysis on a combined dataset.
CONCLUSIONS
The results of the health-economic evaluation of the RECOVER-E project will contribute to the growing evidence base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition.
TRIAL REGISTRATION
(1) ClinicalTrials.gov NCT03922425 (Bulgaria); https://clinicaltrials.gov/ct2/show/NCT03922425 (2) ClinicalTrials.gov NCT03862209 (Croatia); https://clinicaltrials.gov/ct2/show/NCT03862209 (3) ClinicalTrials.gov NCT03892473 (Macedonia); https://clinicaltrials.gov/ct2/show/NCT03892473 (4) ClinicalTrials.gov NCT03837340 (Montenegro); https://clinicaltrials.gov/ct2/show/NCT03837340 (5) ClinicalTrials.gov NCT03884933 (Romania); https://clinicaltrials.gov/ct2/show/NCT03884933.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/17454.",2020,"The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials.
","['Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual [CAU]) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia, and other psychotic disorders', 'people with severe mental disorders', 'Five European Countries', '180 consenting patients']","['CAU or CMHC', 'Community-based recovery-oriented mental health services']",['personal and social functioning and quality-adjusted life years (QALYs'],"[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.29357,"The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials.
","[{'ForeName': 'Ben F M', 'Initials': 'BFM', 'LastName': 'Wijnen', 'Affiliation': 'Center for Economic Evaluation and Machine Learning, Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Center for Economic Evaluation and Machine Learning, Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Ana Ivičević', 'Initials': 'AI', 'LastName': 'Uhernik', 'Affiliation': 'Division of Public Health, Croatian Institute of Public Health, Zagreb, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Istvanovic', 'Affiliation': 'Division of Public Health, Croatian Institute of Public Health, Zagreb, Croatia.'}, {'ForeName': 'Jovo', 'Initials': 'J', 'LastName': 'Dedovic', 'Affiliation': 'Special Psychiatric Hospital Dobrota, Kotor, .'}, {'ForeName': 'Roumyana', 'Initials': 'R', 'LastName': 'Dinolova', 'Affiliation': 'National Centre of Public Health Protection-Mental Health, Sofia, Bulgaria.'}, {'ForeName': 'Raluca', 'Initials': 'R', 'LastName': 'Nica', 'Affiliation': 'Romanian League for Mental Health, Bucharest, Romania.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Velickovski', 'Affiliation': 'University Clinic of Psychiatry, Skopje, the Former Yugoslav Republic of Macedonia.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Service Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ionela', 'Initials': 'I', 'LastName': 'Petrea', 'Affiliation': 'Department of Public Mental Health, Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Shields-Zeeman', 'Affiliation': 'Department of Public Mental Health, Trimbos Institute, Utrecht, Netherlands.'}]",JMIR research protocols,['10.2196/17454']
3285,32476717,Evidence-based adoption of purse-string skin closure for stoma wounds.,"Background
Opinion is divided on the optimal technique of skin closure after stoma reversal as most conventional techniques compromise either on speed/neatness of wound apposition or on the incidence of surgical site infection (SSI). Evidence suggests that purse-string skin closure (PSSC) may achieve both objectives. This study aims to compare conventional primary closure (PC) with PSSC to determine the efficacious technique for stoma wound closure.
Methods
Patients undergoing stoma reversal between April 2015 and September 2017 were prospectively studied. Patients were divided into two groups based on the technique of skin closure (PC or PSSC). The following parameters were assessed: SSI, hospital stay, additional outpatient visit, wound healing time and patient satisfaction based on a standardised questionnaire.
Results
Forty one patients underwent stoma reversal (20 PSSC vs 21 PC). Wound infection, need for wound care, length of hospital stay, healing time and scar size were significantly less, whereas average patient wound satisfaction scores were significantly more in the PSSC group.
Conclusion
Purse-string skin closure (PSSC) proves efficacious and hence merits adoption as the technique of choice for closure of stoma wounds.",2020,"Wound infection, need for wound care, length of hospital stay, healing time and scar size were significantly less, whereas average patient wound satisfaction scores were significantly more in the PSSC group.
","['stoma wounds', 'Patients undergoing stoma reversal between April 2015 and September 2017 were prospectively studied']","['Conclusion\n\n\nPurse-string skin closure (PSSC', 'conventional primary closure (PC) with PSSC', 'purse-string skin closure', 'technique of skin closure (PC or PSSC', 'purse-string skin closure (PSSC']","['SSI, hospital stay, additional outpatient visit, wound healing time\xa0and patient satisfaction based on a standardised questionnaire', 'average patient wound satisfaction scores', 'Wound infection, need for wound care, length of hospital stay, healing time and scar size']","[{'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443313', 'cui_str': 'Stringing'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",41.0,0.0142653,"Wound infection, need for wound care, length of hospital stay, healing time and scar size were significantly less, whereas average patient wound satisfaction scores were significantly more in the PSSC group.
","[{'ForeName': 'Nilotpal', 'Initials': 'N', 'LastName': 'Behuria', 'Affiliation': 'Graded Specialist (Surgery & Gastro-intestinal Surgery), INS Patanjali, Karwar, India.'}, {'ForeName': 'Jayant Kumar', 'Initials': 'JK', 'LastName': 'Banerjee', 'Affiliation': 'Professor (Gastro-intestinal Surgery), Bharati Vidyapeeth Medical College, Pune, India.'}, {'ForeName': 'Sita Ram', 'Initials': 'SR', 'LastName': 'Ghosh', 'Affiliation': 'Consultant (Surgery), Command Hospital (Southern Command), Pune 411040, India.'}, {'ForeName': 'Shrirang Vasant', 'Initials': 'SV', 'LastName': 'Kulkarni', 'Affiliation': 'Classified Specialist ( (Surgery) & Gastro-intestinal Surgeon), Command Hospital (Central Command), Lucknow, India.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Saranga Bharathi', 'Affiliation': 'Classified Specialist ( (Surgery) & Gastro-intestinal Surgeon), Command Hospital (Central Command), Lucknow, India.'}]","Medical journal, Armed Forces India",['10.1016/j.mjafi.2019.02.009']
3286,32481487,"Cardiometabolic Benefits of a Weight-Loss Mediterranean Diet/Lifestyle Intervention in Patients with Obstructive Sleep Apnea: The ""MIMOSA"" Randomized Clinical Trial.","Although continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea (OSA), its cardiometabolic benefits are questionable. Our aim was to explore whether the combination of a weight-loss Mediterranean diet/lifestyle intervention with OSA standard care leads to greater cardiometabolic improvements compared with standard care alone. We randomly assigned 187 adult, overweight, polysomnography-diagnosed moderate-to-severe OSA patients to a standard care group (SCG, n = 65), a Mediterranean diet group (MDG, n = 62) or a Mediterranean lifestyle group (MLG, n = 60). All three groups were prescribed with CPAP. Additionally, the SCG only received brief written healthy lifestyle advice, while intervention arms were subjected to a six-month weight-loss behavioral intervention based on the Mediterranean diet. The MLG also received guidance for improving physical activity and sleep habits. Glucose metabolism indices, blood lipids, liver enzymes and blood pressure improved only in intervention arms, and were significantly lower compared to the SCG post-intervention (all p < 0.05). The age-, sex-, baseline- and CPAP use-adjusted relative risk (95% confidence interval) of metabolic syndrome was 0.58 (0.34-0.99) for the MDG and 0.30 (0.17-0.52) for the MLG compared to the SCG. The MLG additionally presented a lower relative risk of metabolic syndrome compared to the MDG (0.52 (0.30-0.89)). After further adjustment for body-weight change, a lower relative risk of metabolic syndrome was still evident for the MLG compared to the SCG. In conclusion, although standard care alone does not improve OSA patients' cardiometabolic profile, its combination with a weight-loss Mediterranean diet/lifestyle intervention leads to significant cardiometabolic benefits.",2020,"Glucose metabolism indices, blood lipids, liver enzymes and blood pressure improved only in intervention arms, and were significantly lower compared to the SCG post-intervention (all p < 0.05).","['obstructive sleep apnea (OSA', 'Patients with Obstructive Sleep Apnea', '187 adult, overweight, polysomnography-diagnosed moderate-to-severe OSA patients to a']","['weight-loss Mediterranean diet/lifestyle intervention with OSA standard care', 'CPAP', 'SCG only received brief written healthy lifestyle advice, while intervention arms were subjected to a six-month weight-loss behavioral intervention based on the Mediterranean diet', 'standard care group (SCG, n = 65), a Mediterranean diet group (MDG, n = 62) or a Mediterranean lifestyle group (MLG, n = 60', 'continuous positive airway pressure (CPAP', 'Weight-Loss Mediterranean Diet/Lifestyle Intervention']","['Glucose metabolism indices, blood lipids, liver enzymes and blood pressure', 'physical activity and sleep habits', 'relative risk of metabolic syndrome', 'metabolic syndrome']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0012694', 'cui_str': 'Cromolyn sodium'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024443', 'cui_str': 'Madagascar'}, {'cui': 'C0574375', 'cui_str': 'Malagasy language'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",187.0,0.0194322,"Glucose metabolism indices, blood lipids, liver enzymes and blood pressure improved only in intervention arms, and were significantly lower compared to the SCG post-intervention (all p < 0.05).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Georgoulis', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, 70 Eleftheriou Venizelou str., 17671 Athens, Greece.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Yiannakouris', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, 70 Eleftheriou Venizelou str., 17671 Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kechribari', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, 70 Eleftheriou Venizelou str., 17671 Athens, Greece.'}, {'ForeName': 'Kallirroi', 'Initials': 'K', 'LastName': 'Lamprou', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, 45-47 Ipsilantou str., 10676 Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Perraki', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, 45-47 Ipsilantou str., 10676 Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Vagiakis', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, 45-47 Ipsilantou str., 10676 Athens, Greece.'}, {'ForeName': 'Meropi D', 'Initials': 'MD', 'LastName': 'Kontogianni', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, 70 Eleftheriou Venizelou str., 17671 Athens, Greece.'}]",Nutrients,['10.3390/nu12061570']
3287,32481557,"Consumption of Biscuits with a Beverage of Mulberry or Barley Leaves in the Afternoon Prevents Dinner-Induced High, but Not Low, Increases in Blood Glucose among Young Adults.","We examined the impact of consuming biscuits with a beverage of powdered mulberry or barley leaves in the afternoon on postprandial glucose levels at dinnertime among young adults. A total of 18 young adults participated in a partially double-blinded, randomized crossover trial over 2 weeks, consuming either: (1) no biscuits; (2) a biscuit; (3) a biscuit with a beverage of powdered mulberry leaves; or (4) a biscuit with a beverage of powdered barley leaves, as an afternoon snack followed by a standardized test dinner. Glucose levels were recorded after each meal. Results showed intake of biscuits with a beverage of mulberry and barley leaves significantly reduced postprandial rises in glucose after their immediate consumption and dinner, though there was no direct relationship between the glucose levels at the two meals. Compared to those with low glucose levels, participants with high glucose levels at dinner showed a stronger second meal effect, that was attributed to the mulberry or barley leaves, and were also more likely to have lean body weights and prefer evenings. Our findings indicate that eating snacks alongside mulberry or barley leaves is an effective way to suppress postprandial glucose levels in young adults with high glucose levels who prefer evenings.",2020,"Compared to those with low glucose levels, participants with high glucose levels at dinner showed a stronger second meal effect, that was attributed to the mulberry or barley leaves, and were also more likely to have lean body weights and prefer evenings.","['young adults with high glucose levels who prefer evenings', 'young adults', '18 young adults', 'Young Adults']",[],"['Glucose levels', 'Blood Glucose', 'postprandial glucose levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0587117', 'cui_str': 'Evening'}]",[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}]",18.0,0.0253372,"Compared to those with low glucose levels, participants with high glucose levels at dinner showed a stronger second meal effect, that was attributed to the mulberry or barley leaves, and were also more likely to have lean body weights and prefer evenings.","[{'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Kuwahara', 'Affiliation': 'Laboratory of Physiology and Pharmacology, School of Advanced Science and Engineering, Waseda University, Shinjuku-ku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Hyeon-Ki', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Laboratory of Physiology and Pharmacology, School of Advanced Science and Engineering, Waseda University, Shinjuku-ku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Mamiho', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Nanba', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Chijiki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Fukazawa', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Okubo', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Mineshita', 'Affiliation': 'Laboratory of Physiology and Pharmacology, School of Advanced Science and Engineering, Waseda University, Shinjuku-ku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Institute for Liberal Arts, Tokyo Institute of Technology, 2-12-1 Ookayama Meguro-ku, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigenobu', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Laboratory of Physiology and Pharmacology, School of Advanced Science and Engineering, Waseda University, Shinjuku-ku, Tokyo 162-8480, Japan.'}]",Nutrients,['10.3390/nu12061580']
3288,32481563,Effects of Ginseng Ingestion on Salivary Testosterone and DHEA Levels in Healthy Females: An Exploratory Study.,"Ginseng is a traditional herbal adaptogen that has been historically used in China and the Far East. Ginsenosides are the active component of ginseng known to exert several actions by targeting ""multi-receptor systems"", both extracellular and intracellular. In humans, ginseng effects remain unclear. This study aimed to investigate whether ginseng can influence salivary androgen levels (testosterone and dehydroepiandrosterone (DHEA)) in females. The study followed a parallel partially controlled design. Healthy women ( n = 24) were recruited and divided into two groups (A = 20-32 and B = 38-50 years). Volunteers were asked to maintain a food diary pre and post ginseng consumption and collected four salivary samples (7 a.m., 9 a.m., 12 p.m., and 5 p.m.) before and after ingesting 75 mg red Korean ginseng extract per day for seven days. Testosterone and DHEA were then assayed by ELISA methods. Group A's mean daily salivary testosterone pre ginseng ingestion increased from 76.3 ± 16.6 to 98.4 ± 21.1 pg/mL post ginseng (p < 0.01) with significant difference at all time points, and mean daily salivary DHEA increased from 1.53 ± 0.63 to 1.98 ± 0.89 ng/mL post ginseng ( p = 0.02). Group B's mean daily salivary testosterone pre ginseng ingestion was 61.2 ± 16.9 and post ginseng 68.1 ± 11.5 pg/mL ( p = 0.132), and daily salivary DHEA increased from 0.91 ± 0.32 to 1.62 ± 0.49 ng/mL post ginseng ( p = 0.014) with significant difference at all time points. In conclusion, it appears that ginseng intake significantly increased salivary testosterone levels in the younger women group, but only slightly in the older group. However, DHEA levels in the older women showed a marked and significant increase. These results suggest a potential role for ginseng in modulating salivary androgen levels and that such effect may be more evident in older women where the levels of androgens (DHEA) start to decline. However, it has to be stressed that our results are preliminary and further properly controlled trials are justified.",2020,"Group A's mean daily salivary testosterone pre ginseng ingestion increased from 76.3 ± 16.6 to 98.4 ± 21.1 pg/mL post ginseng (p < 0.01) with significant difference at all time points, and mean daily salivary DHEA increased from 1.53 ± 0.63 to 1.98 ± 0.89 ng/mL post ginseng ( p = 0.02).","['females', 'older women', 'Healthy women ( n = 24', 'Healthy Females']","['Ginseng', 'ginseng', 'Ginseng Ingestion']","['Salivary Testosterone and DHEA Levels', 'salivary androgen levels (testosterone and dehydroepiandrosterone (DHEA', 'mean daily salivary testosterone pre ginseng ingestion', 'daily salivary DHEA', 'DHEA levels', 'Testosterone and DHEA', 'salivary testosterone levels', 'mean daily salivary DHEA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]",24.0,0.121192,"Group A's mean daily salivary testosterone pre ginseng ingestion increased from 76.3 ± 16.6 to 98.4 ± 21.1 pg/mL post ginseng (p < 0.01) with significant difference at all time points, and mean daily salivary DHEA increased from 1.53 ± 0.63 to 1.98 ± 0.89 ng/mL post ginseng ( p = 0.02).","[{'ForeName': 'Emad A S', 'Initials': 'EAS', 'LastName': 'Al-Dujaili', 'Affiliation': ""Centre for Cardiovascular Science, Queen's Medical Research Institute, University of Edinburgh, Edinburgh EH16 4TJ, UK.""}, {'ForeName': 'Maha N', 'Initials': 'MN', 'LastName': 'Abu Hajleh', 'Affiliation': 'Department of Pharmaceutical sciences, Faculty of Pharmacy, University of Jordan, Amman 11942, Jordan.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chalmers', 'Affiliation': 'Biological Sciences, Queen Margaret University, Edinburgh EH21 6UU, UK.'}]",Nutrients,['10.3390/nu12061582']
3289,32481623,Changes in Thyroid and Glycemic Status and Food Intake in Children with Excess Weight Who Were Submitted for a Multi-Component School Intervention for 16 Months.,"We investigated if children with excess weight who submitted to two types of intervention at school for 16 months showed improvements in thyroid and glycemic function and food intake. Children (8-11 years) with a body mass index-for-age (BMI/A) of ≥1 Z score were divided into two groups: Treatment 1 ( n = 73) involved motivation to adopt healthier lifestyle; Treatment 2 ( n = 103) involved performing weekly nutritional education, motivational, and physical activities at school. A semi-quantitative food frequency questionnaire was used. The delta BMI/A were similar after 16 months; Treatment 1 showed higher decrease in thyroid-stimulating hormone (TSH; median (range)): -0.45 (-3.19 to 2.17) and 0.06 (-4.57 to 1.63) mIU/L, p = 0.001), FreeT3 (-0.46 (-2.92 to 1.54) and -0.15 (-2.46 to 1.38) pmol/L, p = 0.038), and FreeT4 -1.41 (-6.18 to 3.47) and -0.90 (-4.89 to 2.96) pmol/L, p = 0.018), followed by decrease in energy intake (7304 (6806 to 7840) and 8267 (7739 to 8832) kJ, P treatment = 0.439, P time <0.001, interaction group-time p < 0.001), macronutrients and sugar. A positive correlation between FreeT3 and BMI/A, and a negative correlation with FreeT4 and insulin were found at baseline (r 0.212, p < 0.01; r -0.155, p < 0.01, respectively) and follow-up (r 0.222, p < 0.01; r -0.221, p < 0.01). The decrease in overall diet and particularly sugar intake was accompanied by a greater reduction in TSH and FreeT3 in Treatment 1, demonstrating the impact of dietary intake on thyroid function.",2020,"The delta BMI/A were similar after 16 months; Treatment 1 showed higher decrease in thyroid-stimulating hormone (TSH; median (range)): -0.45 (-3.19 to 2.17) and 0.06 (-4.57 to 1.63) mIU/L, p = 0.001), FreeT3 (-0.46 (-2.92 to 1.54) and -0.15","['Children with Excess Weight', 'children with excess weight who submitted to two types of intervention at school for 16 months', 'Children (8-11 years) with a body mass index-for-age (BMI/A) of ≥1 Z score']","['motivation to adopt healthier lifestyle; Treatment 2 ( n = 103) involved performing weekly nutritional education, motivational, and physical activities at school']","['Thyroid and Glycemic Status and Food Intake', 'thyroid-stimulating hormone', 'thyroid and glycemic function and food intake', 'overall diet and particularly sugar intake', 'energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0203566,"The delta BMI/A were similar after 16 months; Treatment 1 showed higher decrease in thyroid-stimulating hormone (TSH; median (range)): -0.45 (-3.19 to 2.17) and 0.06 (-4.57 to 1.63) mIU/L, p = 0.001), FreeT3 (-0.46 (-2.92 to 1.54) and -0.15","[{'ForeName': 'Vinicius J B', 'Initials': 'VJB', 'LastName': 'Martins', 'Affiliation': 'Department of Physiology and Pathology, Federal University of Paraíba, Health Sciences Center, Campus I, Cidade Universitária, João Pessoa, PB 58051-900, Brazil.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Filgueiras', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, Rua Botucatu, 862, Edifício de Ciências Biomédicas, 2 andar, São Paulo, SP 04023-060, Brazil.'}, {'ForeName': 'Viviane B P', 'Initials': 'VBP', 'LastName': 'Almeida', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, Rua Botucatu, 862, Edifício de Ciências Biomédicas, 2 andar, São Paulo, SP 04023-060, Brazil.'}, {'ForeName': 'Rúbia C S', 'Initials': 'RCS', 'LastName': 'de Moraes', 'Affiliation': 'Department of Nutrition, Federal University of Paraíba, Health Sciences Center, Campus I, Cidade Universitária, João Pessoa, PB 58051-900, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Sawaya', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, Rua Botucatu, 862, Edifício de Ciências Biomédicas, 2 andar, São Paulo, SP 04023-060, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17113825']
3290,32311884,[The derivation and vulidafion of a prediction rule for hypoxemia in infants with Pierre Robin sequence after weaning].,"Objective: To set up a prediction scoring system for the hypoxemia in infants with Pierre Robin sequence after weaning and evaluate its clinical value. Methods: Data of consecutive patients from November 2016 to June 2019, who underwent mandibular distraction osteogenesis in Guangzhou Women and Children's Medical Center, were retrospectively analyzed ( n= 148). All the cases were divided into two groups according to the appearance of hypoxemia after weaning. They were randomly divided into the derivation cohorc (2/3, n= 100) and the validation cohort (1/3, n= 48). Single factor and multiple logistic regression analysis were used to select the independent risk factors related to hypoxemia and establish a prediction model. A prediction scoring system was developed in accordance with assigning of the value of each variable β in the model. Internal verification of scoring system by validation population. Data of consecutive patients from July 2019 to November 2019, who underwent mandibular distraction osteogenesis, were prospectively analyzed ( n= 26). The diagnostic accuracy were conducted to evaluate the clinical value of the scoring system. Results: The logistic regression demonstrated that age at operation, pulmonary infection and the length of distraction less than 5 mm at weaning were the independent risk factors for hypoxemia. The P value of logistic regression model in Hosmer and Lemeshow goodness of fit test was 0.848, and a prediction scoring system was established accordingly. The area under the ROC curve of the scoring system was 0.890, and the optimum critical value was 53. The sensitivity, specificity, accuracy of the model were 78.6%(11/14),86.1%(74/86), 85.0%(85/100) respectively. The predictive effectiveness of the scoring system in the retrospective validation population was similar to that in the modeling population. 26 patients were included in the prospective analysis. The area under ROC curve of the scoring system was 0.870. The sensitivity, specificity and accuracy were 80.0%(5/6),95.0%(20/21), 96.1%(25/26) respectively. Conclusion: The prediction scoring system established in the study are efficacious for the hypoxemia in infants with Pierre Robin sequence after weaning.",2020,"The sensitivity, specificity, accuracy of the model were 78.6%(11/14),86.1%(74/86), 85.0%(85/100) respectively.","['26 patients were included in the prospective analysis', 'infants with Pierre Robin sequence after weaning', ""consecutive patients from November 2016 to June 2019, who underwent mandibular distraction osteogenesis in Guangzhou Women and Children's Medical Center, were retrospectively analyzed ( n= 148"", 'consecutive patients from July 2019 to November 2019, who underwent mandibular distraction osteogenesis, were prospectively analyzed ( n= 26']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0031900', 'cui_str': 'Robin sequence'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0524975', 'cui_str': 'Distraction osteogenesis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]",[],[],26.0,0.0159911,"The sensitivity, specificity, accuracy of the model were 78.6%(11/14),86.1%(74/86), 85.0%(85/100) respectively.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Department of Anaesthesia and Prioperative, Guangzhou Women and Children's Medical Center, Guangzhou 510623, China.""}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Mao', 'Affiliation': ""Department of Stomatology, Guangzhou Women and Children's Medical Center, Guangzhou 510623, China.""}, {'ForeName': 'Y Q', 'Initials': 'YQ', 'LastName': 'Cui', 'Affiliation': ""Department of Stomatology, Guangzhou Women and Children's Medical Center, Guangzhou 510623, China.""}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Xu', 'Affiliation': ""Department of Anaesthesia and Prioperative, Guangzhou Women and Children's Medical Center, Guangzhou 510623, China.""}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': ""Department of Anaesthesia and Prioperative, Guangzhou Women and Children's Medical Center, Guangzhou 510623, China.""}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Tan', 'Affiliation': ""Department of Anaesthesia and Prioperative, Guangzhou Women and Children's Medical Center, Guangzhou 510623, China.""}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20190730-01703']
3291,32476162,"Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial.","BACKGROUND
Eflapegrastim, a novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), consists of a rhG-CSF analog conjugated to a human immuglobulin G4 Fc fragment via a short polyethylene glycol linker. Preclinical and phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for neutrophil counts for eflapegrastim versus pegfilgrastim. This open-label phase III trial compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia.
MATERIALS AND METHODS
Patients with early-stage breast cancer were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim (6 mg G-CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles. The primary objective was to demonstrate the noninferiority of eflapegrastim compared with pegfilgrastim in mean duration of severe neutropenia (DSN; grade 4) in cycle 1.
RESULTS
Eligible patients were randomized 1:1 to study arms (eflapegrastim, n = 196; pegfilgrastim, n = 210). The incidence of cycle 1 severe neutropenia was 16% (n = 31) for eflapegrastim versus 24% (n = 51) for pegfilgrastim, reducing the relative risk by 35% (p = .034). The difference in mean cycle 1 DSN (-0.148 day) met the primary endpoint of noninferiority (p < .0001) and also showed statistical superiority for eflapegrastim (p = .013). Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms.
CONCLUSION
These results demonstrate noninferiority and comparable safety for eflapegrastim at a lower G-CSF dose versus pegfilgrastim. The potential for increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study in patients at higher risk for CIN.
IMPLICATIONS FOR PRACTICE
Chemotherapy-induced neutropenia (CIN) remains a significant clinical dilemma for oncology patients who are striving to complete their prescribed chemotherapy regimen. In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, we discerned noninferiority and comparable safety for eflapegrastim and pegfilgrastim. Nevertheless, the risk of CIN remains a momentous concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations.",2020,"Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms.
","['patients at higher risk for CIN', 'oncology patients who are striving to complete their prescribed chemotherapy regimen', 'Patients with early-stage breast cancer', 'Eligible patients']","['pegfilgrastim', 'eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim', 'eflapegrastim with pegfilgrastim', 'standard docetaxel plus cyclophosphamide chemotherapy']","['mean cycle 1 DSN', 'incidence of cycle 1 severe neutropenia', 'neutrophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1827687', 'cui_str': 'Chemotherapy-induced neutropenia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}]",,0.0418564,"Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms.
","[{'ForeName': 'LeeS', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'West Cancer Center, Germantown, Tennessee, USA.'}, {'ForeName': 'Gajanan', 'Initials': 'G', 'LastName': 'Bhat', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Peguero', 'Affiliation': 'Oncology Consultants PA, Houston, Texas, USA.'}, {'ForeName': 'Richy', 'Initials': 'R', 'LastName': 'Agajanian', 'Affiliation': 'The Oncology Institute of Hope and Innovation, Downey, California, USA.'}, {'ForeName': 'Jayaram S', 'Initials': 'JS', 'LastName': 'Bharadwaj', 'Affiliation': 'Pacific Cancer Medical Center, Anaheim, California, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Restrepo', 'Affiliation': 'Texas Oncology PA, McAllen, Texas, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hlalah', 'Affiliation': 'Bond Clinic PA, Winter Haven, Florida, USA.'}, {'ForeName': 'Inderjit', 'Initials': 'I', 'LastName': 'Mehmi', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Simi Valley, California, USA.'}, {'ForeName': 'Shanta', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Hasal', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Zane', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Spectrum Pharmaceuticals, Inc., Irvine, California, USA.'}, {'ForeName': 'Patrick Wayne', 'Initials': 'PW', 'LastName': 'Cobb', 'Affiliation': 'Frontier Cancer Center, Billings, Montana, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0105']
3292,32476164,An uncontrolled pilot feasibility trial of an intuitive eating intervention for college women with disordered eating delivered through group and guided self-help modalities.,"OBJECTIVE
College women engage in high rates of disordered eating behaviors (DEBs), and most do not receive treatment. Campuses lack resources to meet this need, thus accessible and affordable treatment options are important. Intuitive eating (IE) is gaining mainstream interest, but intervention research is scarce, with no known clinical trials in college women. This uncontrolled pilot trial examined the feasibility, acceptability, and preliminary efficacy of an eight-week IE intervention delivered through two potentially accessible and affordable modalities: group and guided self-help (GSH).
METHOD
Racially and ethnically diverse college women (N = 71; <50% White) were recruited from a large public Mid-Atlantic university and randomized to group (n = 40) or GSH (n = 31). Assessments occurred at 0 (pre-test), 8 (post-test), and 16 weeks (follow-up). Group participants attended eight weekly 1.5-hour sessions. GSH participants engaged in self-study and had eight weekly 20-minute phone calls.
RESULTS
Both conditions demonstrated feasibility, with superior retention and attendance in GSH. Over 90% of those attending at least one session in either condition were retained through follow-up. Both conditions were highly acceptable, and produced medium to large reductions in DEBs, body dissatisfaction, and weight-bias internalization, and improvements in body appreciation, IE, and satisfaction with life from pre- to post-test, which were maintained at follow-up.
DISCUSSION
Results of this pilot are encouraging and support the development of a larger randomized controlled trial. Avenues for refinement include strategies to improve feasibility of the group condition, and conducting longer-term follow-up to examine maintenance of effects and the intervention's eating disorder prevention potential.",2020,"Both conditions were highly acceptable, and produced medium to large reductions in DEBs, body dissatisfaction, and weight-bias internalization, and improvements in body appreciation, IE, and satisfaction with life from pre- to post-test, which were maintained at follow-up.
","['college women', 'Racially and ethnically diverse college women (N = 71; <50% White) were recruited from a large public Mid-Atlantic university and randomized to group (n = 40) or', 'college women with disordered eating delivered through group and guided self-help modalities', 'College women engage in high rates of disordered eating behaviors (DEBs']","['guided self-help (GSH', 'GSH', 'intuitive eating intervention']","['DEBs, body dissatisfaction, and weight-bias internalization, and improvements in body appreciation, IE, and satisfaction with life']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.06782,"Both conditions were highly acceptable, and produced medium to large reductions in DEBs, body dissatisfaction, and weight-bias internalization, and improvements in body appreciation, IE, and satisfaction with life from pre- to post-test, which were maintained at follow-up.
","[{'ForeName': 'C Blair', 'Initials': 'CB', 'LastName': 'Burnette', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, USA.'}]",The International journal of eating disorders,['10.1002/eat.23319']
3293,32476183,Does the Sequence of Anthracycline and Taxane Matter? The NeoSAMBA Trial.,"BACKGROUND
Taxanes usually follow anthracyclines in breast cancer neo/adjuvant treatment, likely because of their later introduction into clinical practice. However, there is no biological rationale that justifies this current standard of care. We compared a taxane followed by an anthracycline-based regimen with the reverse sequence in the neoadjuvant setting.
PATIENTS AND METHODS
In a randomized, open-label, single-center phase II trial, women with inoperable, locally advanced, HER2-negative breast cancer were stratified by hormone receptor status and randomized to three cycles of docetaxel (T) followed by three cycles of fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus three cycles of FAC followed by three cycles of docetaxel. Surgery, radiotherapy, and adjuvant hormonal therapy were administered as per local guidelines. The primary endpoint was pathological complete response (pCR), and secondary endpoints included toxicity, event-free survival (EFS), and overall survival (OS).
RESULTS
Treatment sequence did not improve pCR, which was 7% with T-FAC and 3% with FAC-T. However, after a median follow-up of 79 months, the 5-year EFS rate was 75.7% (95% confidence interval [CI], 65.4%-87.7%) with T-FAC and 48.2% (95% CI, 37.0%-62.7%) with FAC-T (hazard ratio [HR], 0.46; 95% CI, 0.26-0.81; log-rank p = .0054), and the 5-year OS rate was 89.7% (95% CI, 82.2%-97.8%) with T-FAC and 64.7% (95% CI, 53.6%-78.1%) with FAC-T (HR, 0.41; 95% CI, 0.22-0.78; p = .0052). There were no unexpected toxicities.
CONCLUSION
We showed for the first time an improvement in EFS and OS with taxane-first compared with anthracycline-first sequencing chemotherapy in HER2-negative, locally advanced breast cancer. Confirmation of these results may have implications for clinical practice. This trial was registered with Clinicatrials.gov identifier NCT01270373.
IMPLICATIONS FOR PRACTICE
The NeoSAMBA trial showed a benefit for taxane-first sequencing chemotherapy consistent with the systematic review of the literature as well as the larger Neo-tAnGo study. Many recent and current ongoing clinical trials have already followed this treatment strategy. As a taxane-before-anthracycline sequence carries neither an incremental cost nor an increased toxicity, and given the available literature on this issue, reinforced taxane-first regimen can be easily incorporated into daily clinical practice while we wait for confirmation of these findings from larger trials.",2020,"RESULTS
Treatment sequence did not improve pCR, which was 7% with T-FAC and 3% with FAC-T.","['women with inoperable, locally advanced, HER2-negative breast cancer', 'HER2-negative, locally advanced breast cancer']","['taxane-before-anthracycline sequence', 'docetaxel', 'docetaxel (T) followed by three cycles of fluorouracil, doxorubicin, and cyclophosphamide (FAC', 'taxane', 'taxane-first sequencing chemotherapy', 'anthracycline-first sequencing chemotherapy', 'Surgery, radiotherapy, and adjuvant hormonal therapy']","['pCR', 'pathological complete response (pCR), and secondary endpoints included toxicity, event-free survival (EFS), and overall survival (OS', 'toxicities', '5-year OS rate', '5-year EFS rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.165929,"RESULTS
Treatment sequence did not improve pCR, which was 7% with T-FAC and 3% with FAC-T.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Bines', 'Affiliation': 'Medical Oncology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Isabele', 'Initials': 'I', 'LastName': 'Small', 'Affiliation': 'Clinical Research, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Sarmento', 'Affiliation': 'Clinical Research, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Kestelman', 'Affiliation': 'Radiology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Silvania', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Clinical Research, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Rodrigues', 'Affiliation': 'Pathology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Faroni', 'Affiliation': 'Radiation Oncology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Medical Oncology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Ebecken', 'Affiliation': 'Medical Oncology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Maroun', 'Affiliation': 'Surgery, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Millen', 'Affiliation': 'Surgery, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bonamino', 'Affiliation': 'Basic Research, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}]",The oncologist,['10.1634/theoncologist.2019-0805']
3294,32476236,Microbiota changes induced by microencapsulated sodium butyrate in patients with inflammatory bowel disease.,"BACKGROUND
Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. We investigated the effect of a colonic-delivery formulation of butyrate on the fecal microbiota of patients with inflammatory bowel diseases (IBDs).
METHODS
In this double-blind, placebo-controlled, pilot study, 49 IBD patients (n = 19 Crohn's disease, CD and n = 30 ulcerative colitis, UC) were randomized to oral administration of microencapsulated-sodium-butyrate (BLM) or placebo for 2 months, in addition to conventional therapy. Eighteen healthy volunteers (HVs) were recruited to provide a healthy microbiota model of the local people. Fecal microbiota from stool samples was assessed by 16S sequencing. Clinical disease activity and quality of life (QoL) were evaluated before and after treatment.
KEY RESULTS
At baseline, HVs showed a different microbiota composition compared with IBD patients. Sodium-butyrate altered the gut microbiota of IBD patients by increasing bacteria able to produce SCFA in UC patients (Lachnospiraceae spp.) and the butyrogenic colonic bacteria in CD patients (Butyricicoccus). In UC patients, QoL was positively affected by treatment.
CONCLUSIONS AND INFERENCES
Sodium-butyrate supplementation increases the growth of bacteria able to produce SCFA with potentially anti-inflammatory action. The clinical impact of this finding requires further investigation.",2020,"At baseline, HVs showed a different microbiota composition compared with IBD patients.","[""49 IBD patients (n\xa0=\xa019 Crohn's disease, CD and n\xa0=\xa030 ulcerative colitis, UC"", 'patients with inflammatory bowel diseases (IBDs', 'patients suffering from various colonic diseases', 'patients with inflammatory bowel disease', 'Eighteen healthy volunteers (HVs']","['Sodium-butyrate', 'microencapsulated-sodium-butyrate (BLM) or placebo', 'butyrate', 'microencapsulated sodium butyrate', 'placebo']","['Clinical disease activity and quality of life (QoL', 'QoL']","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009373', 'cui_str': 'Disorder of colon'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0142812', 'cui_str': 'Butyric Acid, Sodium Salt'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",49.0,0.0508898,"At baseline, HVs showed a different microbiota composition compared with IBD patients.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Facchin', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vitulo', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Calgaro', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buda', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Romualdi', 'Affiliation': 'Department of Biology, University of Padua, Padua, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pohl', 'Affiliation': 'Department of Gastroenterology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Perini', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Lorenzon', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Marinelli', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': ""D'Incà"", 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Giacomo Carlo', 'Initials': 'GC', 'LastName': 'Sturniolo', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}, {'ForeName': 'Edoardo Vincenzo', 'Initials': 'EV', 'LastName': 'Savarino', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13914']
3295,32476513,Feasibility and Effects of a Supervised Exercise Program Suitable for Independent Training at Home on Physical Function and Quality of Life in Head and Neck Cancer Patients: A Pilot Study.,"Introduction: Head and neck cancer patients often suffer from physical and cognitive impairments after cancer treatment. During rehabilitation, exercise therapy can improve physical function and quality of life (QoL). Surveys demonstrated patients' preference for home training with low- to moderate-intensity. This study was conducted in order to develope a suitable home-based training program. Therefore, the feasibility and effects of a low- to moderate-intensity exercise intervention on physical functions and QoL were evaluated. Methods: Training was conducted as supervised group training and consisted of mobilization, coordination, resistance, stretching, and relaxation exercises. The intervention lasted 12 weeks with 2 training sessions per week. Feasibility, attendance rate, physical function (eg, range of motion, 6-minute walk test [6MWT]), and QoL (eg, EORTC QLQ-30) were analyzed. Results: Ten out of 12 participants completed the intervention (83%) with an average attendance rate of 83%. Participants showed significant improvements in selected physical functions. For example, head rotation increased by 11.2° ( P = .042), walking distance in the 6MWT increased by an average of 43.3 m ( P = .010), and the global QoL scale improved by 8.2 points ( P = .059). Additionally, there were positive changes in the physical function scale ( P = .008), cognitive function scale ( P = .015), and social function scale ( P = .031) of the EORTC QLQ-30. Conclusion : Data indicate that the exercise program was feasible and had positive effects on physical function and QoL. Future research will analyze the effects of a home-based exercise program on physical function and QoL in a large-scale study.",2020,"For example, head rotation increased by 11.2° ( P = .042), walking distance in the 6MWT increased by an average of 43.3 m ( P = .010), and the global QoL scale improved by 8.2 points ( P = .059).","['12 participants completed the intervention (83%) with an average attendance rate of 83', 'Head and Neck Cancer Patients', 'cancer patients often suffer from physical and cognitive impairments after cancer treatment']","['exercise therapy', 'supervised group training and consisted of mobilization, coordination, resistance, stretching, and relaxation exercises', 'Supervised Exercise Program', 'low- to moderate-intensity exercise intervention']","['Feasibility, attendance rate, physical function (eg, range of motion, 6-minute walk test [6MWT]), and QoL (eg, EORTC QLQ-30', 'cognitive function scale', 'Physical Function and Quality of Life', 'physical function and quality of life (QoL', 'physical functions and QoL', 'walking distance in the 6MWT', 'social function scale', 'selected physical functions', 'head rotation', 'global QoL scale', 'physical function scale']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0203993', 'cui_str': 'Relaxation exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",12.0,0.0150438,"For example, head rotation increased by 11.2° ( P = .042), walking distance in the 6MWT increased by an average of 43.3 m ( P = .010), and the global QoL scale improved by 8.2 points ( P = .059).","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Felser', 'Affiliation': 'Department of Medicine, Clinic III - Hematology, Oncology and Palliative Care, Rostock University Medical Center, Rostock Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Behrens', 'Affiliation': 'Institute of Sport Science, University of Rostock, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Liese', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Daniel Fabian', 'Initials': 'DF', 'LastName': 'Strueder', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Rhode', 'Affiliation': 'Department of Physiotherapy, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Junghanss', 'Affiliation': 'Department of Medicine, Clinic III - Hematology, Oncology and Palliative Care, Rostock University Medical Center, Rostock Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Grosse-Thie', 'Affiliation': 'Department of Medicine, Clinic III - Hematology, Oncology and Palliative Care, Rostock University Medical Center, Rostock Germany.'}]",Integrative cancer therapies,['10.1177/1534735420918935']
3296,32476558,"Effects of web-based education and counselling for patients with systemic lupus erythematosus: self-efficacy, fatigue and assessment of care.","OBJECTIVE
The aim of this study was to determine the effect of web-based education and counselling for patients with systemic lupus erythematosus on self-efficacy, fatigue and assessment of care.
METHODS
The study was conducted as a randomized controlled trial. The study sample consisted of 80 patients divided into two groups: the experimental group ( n = 40) and a control group ( n = 40). Randomization was performed by simple random sampling. At the beginning of the study (month 0), data-collection forms were administered to both groups. Web-based education was carried out for the first three months, and counselling and information updates were given for the next three months for the experimental group. In the intervention process, the control group just received standard care. After six months, data-collection forms were administered to both groups again.
RESULTS
The mean age of the participants in the experimental and control groups was 35.58 ± 8.40 years and 39.00 ± 12.71 years, respectively. In both groups, 95% of patients were women. Wilcoxon's test was used for within-group comparisons before and after the study. The Mann-Whitney U -test was used to evaluate the difference between the two groups before the intervention and between the two groups after the intervention. We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study ( p < 0.05).
CONCLUSIONS
The intervention had a positive effect on self-efficacy, fatigue and satisfaction with chronic illness. In accordance with the results, similar studies should be conducted for different patient groups in order to strengthen the results.",2020,"We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study ( p < 0.05).
","['The mean age of the participants in the experimental and control groups was 35.58\u2009±\u20098.40 years and 39.00\u2009±\u200912.71 years, respectively', 'patients with systemic lupus erythematosus']","['standard care', 'web-based education and counselling']","['fatigue, self-efficacy and assessment of chronic illness care', 'self-efficacy, fatigue and satisfaction with chronic illness']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",80.0,0.0447442,"We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study ( p < 0.05).
","[{'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Kankaya', 'Affiliation': 'Ege University, Faculty of Nursing, Department of Medical Nursing, Izmir, Turkey.'}, {'ForeName': 'Ayfer', 'Initials': 'A', 'LastName': 'Karadakovan', 'Affiliation': 'Ege University, Faculty of Nursing, Department of Medical Nursing, Izmir, Turkey.'}]",Lupus,['10.1177/0961203320928423']
3297,32476617,Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up.,"Background . Vagus nerve stimulation (VNS) paired with rehabilitation may improve upper-limb impairment and function after ischemic stroke. Objective . To report 1-year safety, feasibility, adherence, and outcome data from a home exercise program paired with VNS using long-term follow-up data from a randomized double-blind study of rehabilitation therapy paired with Active VNS (n = 8) or Control VNS (n = 9). Methods . All people were implanted with a VNS device and underwent 6 weeks in clinic therapy with Control or Active VNS followed by home exercises through day 90. Thereafter, participants and investigators were unblinded. The Control VNS group then received 6 weeks in-clinic Active VNS (Cross-VNS group). All participants then performed an individualized home exercise program with self-administered Active VNS. Data from this phase are reported here. Outcome measures were Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log. Results . There were no VNS treatment-related serious adverse events during the long-term therapy. Two participants discontinued prior to receiving the full crossover VNS. On average, participants performed 200 ± 63 home therapy sessions, representing device use on 57.4% of home exercise days available for each participant. Pooled analysis revealed that 1 year after randomization, the FMA-UE score increased by 9.2 points (95% CI = 4.7 to 13.7; P = .001; n = 15). Other functional measures were also improved at 1 year. Conclusions . VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.",2020,"VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.",['After Stroke'],"['clinic therapy with Control or Active VNS followed by home exercises through day 90', 'rehabilitation therapy paired with Active VNS (n = 8) or Control VNS', 'Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation', 'home exercise program paired with VNS', 'individualized home exercise program with self-administered Active VNS', 'VNS combined with rehabilitation', 'Vagus nerve stimulation (VNS) paired with rehabilitation']","['Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log', 'FMA-UE score', 'VNS treatment-related serious adverse events']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.123532,"VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.","[{'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Navzer D', 'Initials': 'ND', 'LastName': 'Engineer', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Cecília N', 'Initials': 'CN', 'LastName': 'Prudente', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pierce', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Francisco', 'Affiliation': 'The University of Texas Health Science Center at Houston (UTHealth), TX, USA.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Yozbatiran', 'Affiliation': 'The University of Texas Health Science Center at Houston (UTHealth), TX, USA.'}, {'ForeName': 'W Brent', 'Initials': 'WB', 'LastName': 'Tarver', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Casavant', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Kline', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Cramer', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Van de Winckel', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Kimberley', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320924361']
3298,32476619,Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study.,"Background . Many research studies attempting to improve locomotor function following motor incomplete spinal cord injury (iSCI) focus on providing stepping practice. However, observational studies of physical therapy strategies suggest the amount of stepping practice during clinical rehabilitation is limited; rather, many interventions focus on mitigating impairments underlying walking dysfunction. Objective . The purpose of this blinded-assessor randomized trial was to evaluate the effects of task-specific versus impairment-based interventions on walking outcomes in individuals with iSCI. Methods . Using a crossover design, ambulatory participants with iSCI >1-year duration performed either task-specific (upright stepping) or impairment-based training for up to 20 sessions over ≤6 weeks, with interventions alternated after >4 weeks delay. Both strategies focused on achieving higher cardiovascular intensities, with training specificity manipulated by practicing only stepping practice in variable contexts or practicing tasks targeting impairments underlying locomotor dysfunction (strengthening, balance tasks, and recumbent stepping). Results . Significantly greater increases in fastest overground and treadmill walking speeds were observed following task-specific versus impairment-based training, with moderate associations between differences in amount of practice and outcomes. Gains in balance confidence were also observed following task-specific vs impairment-based training, although incidence of falls was also increased with the former protocol. Limited gains were observed with impairment-based training except for peak power during recumbent stepping tests. Conclusion . The present study reinforces work from other patient populations that the specificity of task practice is a critical determinant of locomotor outcomes and suggest impairment-based exercises may not translate to improvements in functional tasks. Clinical Trial Registration URL . https://clinicaltrials.gov/ ; Unique Identifier: NCT02115685.",2020,"Significantly greater increases in fastest overground and treadmill walking speeds were observed following task-specific versus impairment-based training, with moderate associations between differences in amount of practice and outcomes.","['Individuals With Chronic Spinal Cord Injury', 'individuals with iSCI', 'ambulatory participants with iSCI >1-year duration performed either']","['Task-Specific Versus Impairment-Based Training', 'task-specific versus impairment-based interventions', 'task-specific (upright stepping) or impairment-based training']","['Gains in balance confidence', 'incidence of falls', 'Locomotor Performance', 'walking outcomes', 'fastest overground and treadmill walking speeds']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",,0.0682405,"Significantly greater increases in fastest overground and treadmill walking speeds were observed following task-specific versus impairment-based training, with moderate associations between differences in amount of practice and outcomes.","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Lotter', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Plawecki', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Holthus', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Lucas', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Marzieh M', 'Initials': 'MM', 'LastName': 'Ardestani', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320927384']
3299,32477035,Integrating Health Coaching With a Medical Fitness Program to Treat Chronic Health Conditions.,"Medical fitness and health/wellness coaching (HWC) are emerging health care trends but potential synergistic effects are yet to be studied.
PURPOSE
To determine the impact of integrating HWC within a community-based medical fitness program for patients with chronic health conditions.
METHODS
A before and after clinical trial, examining 3 frequency levels of coaching sessions, with Journey-to-Wellness (J2W) participants (N = 1306) who were predominately female (76%), aged 12 to 87 years (mean ± SD = 53.54 ± 14.34 years), and referred by their health care provider. Over 3 months, J2W emphasized HWC, exercise, nutrition counseling, and group/interactive events. HWC averaged 4.4 ± 2.5 sessions and was analyzed at 3 levels (0-3; 4-6; 6+ sessions). Pre-post measures were Patient Health Questionnaire (PHQ-9), Positivity, General Anxiety Disorder (GAD-7), Dartmouth Quality of Life (QoL), Lifestyle Nutrition Behavior (LNB), Pain, exercise minutes, weight, waist circumference, and systolic/diastolic blood pressures.
RESULTS
J2W intervention significantly (P < .01) improved all outcomes. Between 20% and 43% improvements were observed for PHQ-9, GAD-7, QoL while LNB improved 7.5%, and biometrics between 1% and 2.2%. Greater frequency of HWC enhanced J2W effect for PHQ-9 and QoL with weight and GAD approaching significance.
CONCLUSION
J2W programming produced measurable improvement in health metrics, with greater HWC frequency adding to these beneficial effects, providing a powerful community-based health intervention.",2020,"Between 20% and 43% improvements were observed for PHQ-9, GAD-7, QoL while LNB improved 7.5%, and biometrics between 1% and 2.2%.","['patients with chronic health conditions', 'participants (N = 1306) who were predominately female (76%), aged 12 to 87 years (mean ± SD = 53.54 ± 14.34 years), and referred by their health care provider']","['Medical fitness and health/wellness coaching (HWC', 'coaching sessions, with Journey-to-Wellness (J2W', 'HWC within a community-based medical fitness program']","['PHQ-9, GAD-7, QoL while LNB improved 7.5%, and biometrics', 'health metrics', 'Patient Health Questionnaire (PHQ-9), Positivity, General Anxiety Disorder (GAD-7), Dartmouth Quality of Life (QoL), Lifestyle Nutrition Behavior (LNB), Pain, exercise minutes, weight, waist circumference, and systolic/diastolic blood pressures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4704932', 'cui_str': 'Health Metrics'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",1306.0,0.0176845,"Between 20% and 43% improvements were observed for PHQ-9, GAD-7, QoL while LNB improved 7.5%, and biometrics between 1% and 2.2%.","[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Roy', 'Affiliation': 'Summit Medical Fitness Center at Kalispell Regional Medical Center, Kalispell, Montana (BR, PR, CL).'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Roberts', 'Affiliation': 'Summit Medical Fitness Center at Kalispell Regional Medical Center, Kalispell, Montana (BR, PR, CL).'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Lisowski', 'Affiliation': 'Summit Medical Fitness Center at Kalispell Regional Medical Center, Kalispell, Montana (BR, PR, CL).'}, {'ForeName': 'Miranda P', 'Initials': 'MP', 'LastName': 'Kaye', 'Affiliation': 'Summit Medical Fitness Center at Kalispell Regional Medical Center, Kalispell, Montana (BR, PR, CL).'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Sforzo', 'Affiliation': 'Summit Medical Fitness Center at Kalispell Regional Medical Center, Kalispell, Montana (BR, PR, CL).'}]",American journal of lifestyle medicine,['10.1177/1559827617728025']
3300,32477037,Impact Assessment of an Innovative Integrated Care Model for Older Complex Patients with Multimorbidity: The CareWell Project.,"Objectives
To evaluate the impact in terms of use of health services, clinical outcomes, functional status, and patient's satisfaction of an integrated care program, the CareWell program, for complex patients with multimorbidity, supported by information and communication technology platforms in six European regions.
Data Sources
Primary data were used and the follow-up period ranged between 8 and 12 months.
Study design
A quasi-experimental study, targeting chronic patients aged 65 or older, with 2 or more conditions - one of them necessarily being diabetes, congestive heart failure or congestive obstructive pulmonary disease. The intervention group received the integrated care program and the control group received usual care. Generalized mixed regression models were used.
Data collection
Data were obtained from individual interviews and electronic clinical records.
Principal Findings
Overall, 856 patients were recruited (475 intervention and 381 control). In the intervention group, the number of visits to emergency rooms was significantly lower, and the number of visits to the general practitioners and primary care nurses was higher than in the control group.
Conclusion
The CareWell program resulted in improvements in the use of health services, strengthening the role of PC as the cornerstone of care provision for complex patients with multimorbidity.",2020,"In the intervention group, the number of visits to emergency rooms was significantly lower, and the number of visits to the general practitioners and primary care nurses was higher than in the control group.
","['complex patients with multimorbidity', 'Older Complex Patients with Multimorbidity', 'chronic patients aged 65 or older, with 2 or more conditions ', 'complex patients with multimorbidity, supported by information and communication technology platforms in six European regions', '856 patients were recruited (475 intervention and 381 control']","['Innovative Integrated Care Model', 'integrated care program and the control group received usual care']","['number of visits to the general practitioners and primary care nurses', 'number of visits to emergency rooms']","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517894', 'cui_str': '856'}, {'cui': 'C4517786', 'cui_str': '475'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",856.0,0.0169762,"In the intervention group, the number of visits to emergency rooms was significantly lower, and the number of visits to the general practitioners and primary care nurses was higher than in the control group.
","[{'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Mateo-Abad', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, ES.'}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Fullaondo', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, ES.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Merino', 'Affiliation': 'Osakidetza Basque Health Sevice, Tolosaldea Integrated Health Care Organization, Tolosa, Basque Country, ES.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gris', 'Affiliation': 'Azienda ULSS 1 Dolomiti, Local Health Authority, Feltre, Belluno, IT.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Marchet', 'Affiliation': 'Azienda ULSS 1 Dolomiti, Local Health Authority, Feltre, Belluno, IT.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Avolio', 'Affiliation': 'Agenzia Regionale per la salute e Sociale - Regione Puglia, Bari, Puglia, IT.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Graps', 'Affiliation': 'Health Technology Assessment - UNIT, Regional Strategic Agency for Health and Social Affair (AReSS), Bari, IT.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ravic', 'Affiliation': 'Ericsson Nikola Tesla d.d., Zagreb, HR.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Kovac', 'Affiliation': 'Dept. of Control and Computer Engineering, Faculty of Electrical Engineering and Computing, University of Zagreb, Zagreb, HR.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Benkovic', 'Affiliation': 'Croatian Society for Pharmacoeconomics and Health Economics, Zagreb, HR.'}, {'ForeName': 'Ranko', 'Initials': 'R', 'LastName': 'Stevanovic', 'Affiliation': 'Croatian Society for Pharmacoeconomics and Health Economics, Zagreb, HR.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Zwiefka', 'Affiliation': 'Department of Health, LSV Marshal Office, PL.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Davies', 'Affiliation': 'Powys Teaching Health Board, Bronllys Hospital, Bronllys, Powys, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mancin', 'Affiliation': ""Arsenàl.IT, Veneto's Research Centre for eHealth Innovation, Treviso, IT.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Forestiero', 'Affiliation': ""Arsenàl.IT, Veneto's Research Centre for eHealth Innovation, Treviso, IT.""}, {'ForeName': 'Panos', 'Initials': 'P', 'LastName': 'Stafylas', 'Affiliation': 'HealThink, Thessaloniki, GR.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Hurtado', 'Affiliation': 'Health Information Management S.A. - HIM S.A., MAST European Economic Interest Group, Brussels, BE.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': ""d'Angelantonio"", 'Affiliation': 'Health Information Management S.A. - HIM S.A., MAST European Economic Interest Group, Brussels, BE.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Daugbjerg', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, DK.'}, {'ForeName': 'Claus Duedal', 'Initials': 'CD', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, DK.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hammerschmidt', 'Affiliation': 'Empirica Communication and Technology Research, Bonn, DE.'}, {'ForeName': 'Veli', 'Initials': 'V', 'LastName': 'Stroetmann', 'Affiliation': 'Empirica Communication and Technology Research, Bonn, DE.'}, {'ForeName': 'Lierni', 'Initials': 'L', 'LastName': 'Azkargorta', 'Affiliation': 'Osakidetza Basque Health Sevice, Tolosaldea Integrated Health Care Organization, Tolosa, Basque Country, ES.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Giné', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, ES.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Verdoy', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, ES.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Soto-Gordoa', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, ES.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Mora', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, ES.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Mar', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Barakaldo, Basque Country, ES.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Vergara', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, ES.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'de Manuel Keenoy', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, ES.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of integrated care,['10.5334/ijic.4711']
3301,32477049,Sex Differences in the Response to Different Tinnitus Treatment.,"Introduction
Tinnitus is a complex symptom requiring a thorough multidisciplinary assessment to construct an individual's tinnitus profile. The Antwerp University Hospital hosts a tertiary tinnitus clinic providing intensive, multidisciplinary tinnitus care in the form of combinational psychological treatment with either Tinnitus Retraining Therapy (TRT)/Cognitive Behavioral Therapy (CBT) or TRT/eye movement desensitization and reprocessing therapy (EMDR), high-definition transcranial direct current stimulation (HD-tDCS), and physical therapy treatment (in cases of somatic influence of the neck or the temporomandibular area). Several factors may contribute to therapy effect of which the role of gender has recently gained more interest. As such, the current manuscript explores gender differences in the outcome of different tinnitus treatments.
Methods
Data on treatment outcome of four distinct tinnitus treatments (1. HD-tDCS; 2. orofacial physical therapy; 3. combination TRT + CBT; and 4. combination TRT + EMDR) were pooled and compared. Treatment outcome was assessed via the Tinnitus Functional Index (TFI). Participants completed the TFI at baseline, immediately after treatment and after 9 weeks (±3 weeks) follow-up. To explore the effect of gender on different treatment outcomes, a linear mixed model was designed including Time point , Gender , and Therapy Group as fixed factors as well as all interactions between these factors.
Results
TFI scores improved significantly over time regardless of therapy group ( p < 0.0001). A mean TFI decrease of at least 13 points was obtained by all participants except by those in the HD-tDCS. Significant interactions between Gender and Time point were identified in all groups except for the TRT +EMDR group. Female subjects improved more extensively than males in the HD-tDCS ( p = 0.0009) and orofacial therapy group ( p = 0.0299). Contrarily, in the TRT +CBT group, male participants showed a significant improvement whereas the mean TFI scores of female subjects remained on baseline levels ( p = 0.0138).
Conclusion
Our data suggest that male and female tinnitus patients seem to react differently to different therapy options. We strongly encourage further prospective studies to discern the relevance of gender in therapy outcome.",2020,Female subjects improved more extensively than males in the HD-tDCS ( p = 0.0009) and orofacial therapy group ( p = 0.0299).,"['The Antwerp University Hospital hosts a tertiary tinnitus clinic providing intensive, multidisciplinary tinnitus care in the form of combinational psychological treatment with either', 'male and female tinnitus patients']","['combination TRT + CBT', 'combination TRT + EMDR', 'TRT +EMDR', 'Tinnitus Retraining Therapy (TRT)/Cognitive Behavioral Therapy (CBT) or TRT/eye movement desensitization and reprocessing therapy (EMDR), high-definition transcranial direct current stimulation (HD-tDCS), and physical therapy treatment', 'TRT +CBT']","['mean TFI decrease', 'TFI scores', 'mean TFI scores', 'Tinnitus Functional Index (TFI']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0242129,Female subjects improved more extensively than males in the HD-tDCS ( p = 0.0009) and orofacial therapy group ( p = 0.0299).,"[{'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Van der Wal', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Luyten', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Cardon', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Jacquemin', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Olivier M', 'Initials': 'OM', 'LastName': 'Vanderveken', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Topsakal', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van de Heyning', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Antwerp University, Antwerp, Belgium.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Van Looveren', 'Affiliation': 'Hoorzorg Van Looveren BVBA, Borsbeek, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Van Rompaey', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Michiels', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Gilles', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00422']
3302,32477076,How Much Instructional Time Is Necessary? Mid-intervention Results of Fundamental Movement Skills Training Within ABA Early Intervention Centers.,"Background : The purpose of this study was to explore the question of the minimal amount of instructional time needed to still be effective by assessing the efficacy at mid-intervention of an early fundamental movement skill (FMS) intervention for preschoolers with Autism Spectrum Disorder (ASD). Method : Fourteen preschoolers participated in this randomized controlled trial daily over 10 weeks (10 h total at mid-intervention). A two-factor mixed MANOVA tested the significance of group*time interactions for two dependent variables: object control and locomotor raw scores on the Test of Gross Motor Development-III. Results : Group*time interactions approached significance with large effect sizes on the vector of both dependent variables and in a univariate fashion on object control scores, but not locomotor scores. Conclusions : These findings hold relevance for physical educators working with young children with ASD, indicating that 10 h of FMS instruction, at least in this form, is not adequate to improve FMS.",2020,"Group*time interactions approached significance with large effect sizes on the vector of both dependent variables and in a univariate fashion on object control scores, but not locomotor scores. ","['preschoolers with Autism Spectrum Disorder (ASD', 'young children with ASD', 'Fourteen preschoolers']",['early fundamental movement skill (FMS) intervention'],[],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],14.0,0.0260371,"Group*time interactions approached significance with large effect sizes on the vector of both dependent variables and in a univariate fashion on object control scores, but not locomotor scores. ","[{'ForeName': 'Isabella Theresa', 'Initials': 'IT', 'LastName': 'Felzer-Kim', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, United States.'}, {'ForeName': 'Janet Lynn', 'Initials': 'JL', 'LastName': 'Hauck', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, United States.'}]",Frontiers in integrative neuroscience,['10.3389/fnint.2020.00024']
3303,32477139,"Effects of Dexmedetomidine on Postoperative Delirium and Expression of IL-1β, IL-6, and TNF-α in Elderly Patients After Hip Fracture Operation.","Objective
Postoperative delirium (POD) is a common surgical complication in elderly patients. This study investigated the effects of dexmedetomidine on POD and pro-inflammatory markers in elderly patients with hip fracture.
Methods
This randomized, double-blind, controlled trial enrolled patients ≥65 years of age who underwent an operation for hip fracture at Beijing JiShuiTan Hospital from October 2016 to January 2017. The patients were divided into the DEX group (injected with dexmedetomidine 0.5 µg/kg/h) and the NS group (injected with normal saline). After surgery, the incidence of delirium at postoperative day 1 (T1), 2 (T2), and 3 (T3) was assessed using the Confusion Assessment Method delirium scale. Interleukin (IL)-1β, IL-6, and tumor necrosis factor (TNF)-α blood levels were detected at T0 (before surgery), T1, and T3.
Results
Data from 240 patients were analyzed, with 120/group (intent-to-treat analysis). Dexmedetomidine decreased POD incidence (18.2 vs. 30.6%, P = 0.033). Compared to T0, all three pro-inflammatory markers were higher at T1 and then decreased at T3 (time interaction, all P < 0.001). IL-6 (P < 0.001) levels were lower in the DEX group at T1, and TNF-α (P = 0.003) levels were lower in the DEX group at T1 and T3, but IL-1β levels were similar between the two groups. The rate of adverse events was similar in the two groups.
Conclusion
Dexmedetomidine reduced the incidence of POD in elderly patients on the first day after hip fracture surgery, and reduced IL-6 and TNF-α levels over the first 3 days after surgery.",2020,"(P < 0.001) levels were lower in the DEX group at T1, and TNF-α (P = 0.003) levels were lower in the DEX group at T1 and T3, but IL-1β levels were similar between the two groups.","['elderly patients with hip fracture', '240 patients were analyzed, with 120/group (intent-to-treat analysis', 'elderly patients on the first day after hip fracture surgery', 'Elderly Patients', 'elderly patients', 'patients ≥65 years of age who underwent an operation for hip fracture at Beijing JiShuiTan Hospital from October 2016 to January 2017']","['NS group (injected with normal saline', 'DEX', 'Dexmedetomidine', 'IL-6', 'dexmedetomidine']","['rate of adverse events', 'incidence of POD', 'Postoperative Delirium and Expression of IL-1β, IL-6, and TNF-α', 'incidence of delirium at postoperative day 1 (T1), 2 (T2), and 3 (T3', 'Confusion Assessment Method delirium scale', 'POD incidence', 'IL-1β levels', 'IL-6 and TNF-α levels', 'Interleukin (IL)-1β, IL-6, and tumor necrosis factor (TNF)-α blood levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",240.0,0.166749,"(P < 0.001) levels were lower in the DEX group at T1, and TNF-α (P = 0.003) levels were lower in the DEX group at T1 and T3, but IL-1β levels were similar between the two groups.","[{'ForeName': 'Wenchao', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tianlong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedics & Traumatology, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.00678']
3304,31833413,Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease: Insights From the SYNTAX III REVOLUTION Trial.,"BACKGROUND
Fractional flow reserve (FFR) is a reliable tool for the functional assessment of coronary stenoses. FFR computed tomography (CT) derived (FFR CT ) has shown to be accurate, but its clinical usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the impact of FFR CT on heart team's treatment decision-making and selection of vessels for revascularization in patients with 3-vessel coronary artery disease.
METHODS
The trial was an international, multicenter study randomizing 2 heart teams to make a treatment decision between percutaneous coronary interventions and coronary artery bypass grafting using either coronary computed tomography angiography or conventional angiography. The heart teams received the FFR CT and had to make a treatment decision and planning integrating the functional component of the stenoses. Each heart team calculated the anatomic SYNTAX score, the noninvasive functional SYNTAX score and subsequently integrated the clinical information to compute the SYNTAX score III providing a treatment recommendation, that is, coronary artery bypass grafting, percutaneous coronary intervention, or equipoise coronary artery bypass grafting-percutaneous coronary intervention. The primary objective was to determine the proportion of patients in whom FFR CT changed the treatment decision and planning.
RESULTS
Overall, 223 patients were included. Coronary computed tomography angiography assessment was feasible in 99% of the patients and FFR CT analysis in 88%. FFR CT was available for 1030 lesions (mean FFR CT value 0.64±13). A treatment recommendation of coronary artery bypass grafting was made in 24% of the patients with coronary computed tomography angiography with FFR CT . The addition of FFR CT changed the treatment decision in 7% of the patients and modified selection of vessels for revascularization in 12%. With conventional angiography as reference, FFR CT assessment resulted in reclassification of 14% of patients from intermediate and high to low SYNTAX score tertile.
CONCLUSIONS
In patients with 3-vessel coronary artery disease, a noninvasive physiology assessment using FFR CT changed heart team's treatment decision-making and procedural planning in one-fifth of the patients.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02813473.",2019,The addition of FFR CT changed the treatment decision in 7% of the patients and modified selection of vessels for revascularization in 12%.,"['Patients With Multivessel Coronary Artery Disease', '223 patients were included', 'patients with complex coronary artery disease', 'patients with 3-vessel coronary artery disease']","['Fractional flow reserve (FFR', 'Coronary computed tomography angiography assessment', 'FFR CT', 'Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography', 'coronary computed tomography angiography with FFR CT ', 'conventional angiography', 'FFR computed tomography (CT) derived (FFR CT ', 'coronary artery bypass grafting, percutaneous coronary intervention, or equipoise coronary artery bypass grafting-percutaneous coronary intervention', 'coronary artery bypass grafting', 'percutaneous coronary interventions and coronary artery bypass grafting using either coronary computed tomography angiography or conventional angiography']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0442842', 'cui_str': 'Conventional angiography'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}]",[],223.0,0.0295032,The addition of FFR CT changed the treatment decision in 7% of the patients and modified selection of vessels for revascularization in 12%.,"[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Andreini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, the Netherlands (R.M., Y.K.).'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Katagiri', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, the Netherlands (R.M., Y.K.).'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Mushtaq', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Sonck', 'Affiliation': 'Cardiovascular Center Aalst, OLV Hospital, Belgium (J.S., C.C.).'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Collet', 'Affiliation': 'Cardiovascular Center Aalst, OLV Hospital, Belgium (J.S., C.C.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'De Martini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Roberto', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Belgium (K.T., J.C., D.S.).'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Thoraxcenter, Erasmus MC, the Netherlands (Y.M., Y.O.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Czapla', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Belgium (K.T., J.C., D.S.).'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Schoors', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Belgium (K.T., J.C., D.S.).'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Plass', 'Affiliation': 'University of Zurich, Switzerland (A.P., F.M., P.K.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Maisano', 'Affiliation': 'University of Zurich, Switzerland (A.P., F.M., P.K.).'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kaufmann', 'Affiliation': 'University of Zurich, Switzerland (A.P., F.M., P.K.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Orry', 'Affiliation': 'CHRU Nancy and Universite de Lorraine, Nancy, France (X.O., P.-A.M., T.F.).'}, {'ForeName': 'Pierre-Adrien', 'Initials': 'PA', 'LastName': 'Metzdorf', 'Affiliation': 'CHRU Nancy and Universite de Lorraine, Nancy, France (X.O., P.-A.M., T.F.).'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Folliguet', 'Affiliation': 'CHRU Nancy and Universite de Lorraine, Nancy, France (X.O., P.-A.M., T.F.).'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Färber', 'Affiliation': 'Jena University Hospital, Friedrich Schiller University of Jena, Germany (G.F., I.D.).'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Diamantis', 'Affiliation': 'Jena University Hospital, Friedrich Schiller University of Jena, Germany (G.F., I.D.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schönweiß', 'Affiliation': 'Heinrich Braun Klinikum, Zwickau, Germany (M.S.).'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Bonalumi', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guglielmo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ferrari', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Olivares', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cavallotti', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Leal', 'Affiliation': 'Cardialysis BV, Rotterdam, the Netherlands (I.L., W.L.).'}, {'ForeName': 'Wietze', 'Initials': 'W', 'LastName': 'Lindeboom', 'Affiliation': 'Cardialysis BV, Rotterdam, the Netherlands (I.L., W.L.).'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Thoraxcenter, Erasmus MC, the Netherlands (Y.M., Y.O.).'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, Royal Brompton and Harefield Hospitals, Imperial College London, United Kingdom (P.W.S.).'}, {'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'Bartorelli', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.118.007607']
3305,32482095,Post-exercise provision of 40 g of protein during whole body resistance training further augments strength adaptations in elderly males.,"BACKGROUND
In the elderly, low protein intake exacerbates the effects of sarcopenia and anabolic resistance. Protein supplementation to maximise muscle protein synthesis, may be an effective intervention. Aim: To determine the effects of a low/high dose of protein, ingested immediately post-exercise, during resistance training in novice elderly males. Method: 24 elderly (70.5±5.1, years) males were recruited (body mass: 92.4±14.9 kg; fat free mass: 61.4±7.6 kg). After exclusion criteria, 18 males participated. Participants continued their normal dietary intake and were allocated into two matched groups, then randomly assigned to either a 20 g or 40 g dose intervention. Following determination of 1 repetition maximum (1RM), participants completed 10 x 3d -1 wk resistance training and consumed protein supplements immediately following exercise. Results: Significant improvements in chest press (p = 0.014, ɳp 2 0.34) shoulder press (p = 0.005, ɳp 2 0.43) and leg extension strength (p = 0.014, ɳp 2 0.34), were observed following the 40 g dose, resulting in performance improvements of 19.1, 21.1, and 16.1% respectively, compared to the 20 g dose. Conclusion:Findings suggest that ingesting 40 g of protein following resistance exercise, produces greater responses to training and may be an important nutritional strategy when prescribing resistance exercise in the elderly.",2020,"Significant improvements in chest press (p = 0.014, ɳp 2 0.34) shoulder press (p = 0.005, ɳp 2 0.43) and leg extension strength (p = 0.014, ɳp 2 0.34), were observed following the 40 g dose, resulting in performance improvements of 19.1, 21.1, and 16.1% respectively, compared to the 20 g dose. ","['novice elderly males', '24 elderly (70.5±5.1, years', 'elderly males', 'males were recruited (body mass: 92.4±14.9 kg; fat free mass: 61.4±7.6 kg', '18 males participated', 'Participants continued their normal dietary intake', 'participants completed 10 x 3d -1']","['wk resistance training and consumed protein supplements', 'Post-exercise provision of 40 g of protein during whole body resistance training', 'low/high dose of protein, ingested immediately post-exercise, during resistance training']","['leg extension strength', 'chest press']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",18.0,0.0632351,"Significant improvements in chest press (p = 0.014, ɳp 2 0.34) shoulder press (p = 0.005, ɳp 2 0.43) and leg extension strength (p = 0.014, ɳp 2 0.34), were observed following the 40 g dose, resulting in performance improvements of 19.1, 21.1, and 16.1% respectively, compared to the 20 g dose. ","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Atherton', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Sports Nutrition and Performance Research Group , Ormskirk, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Lars R', 'Initials': 'LR', 'LastName': 'McNaughton', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Sports Nutrition and Performance Research Group , Ormskirk, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Close', 'Affiliation': 'School of Sport and Exercise Sciences, Liverpool John Moores University , Liverpool, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Sparks', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Sports Nutrition and Performance Research Group , Ormskirk, United Kingdom of Great Britain and Northern Ireland.'}]",Research in sports medicine (Print),['10.1080/15438627.2020.1770251']
3306,32483134,The atorvastatin metabolic phenotype shift is influenced by interaction of drug-transporter polymorphisms in Mexican population: results of a randomized trial.,"Atorvastatin (ATV) is a blood cholesterol-lowering drug used to prevent cardiovascular events, the leading cause of death worldwide. As pharmacokinetics, metabolism and response vary among individuals, we wanted to determine the most reliable metabolic ATV phenotypes and identify novel and preponderant genetic markers that affect ATV plasma levels. A controlled, randomized, crossover, single-blind, three-treatment, three-period, and six-sequence clinical study of ATV (single 80-mg oral dose) was conducted among 60 healthy Mexican men. ATV plasma levels were measured using high-performance liquid chromatography mass spectrometry. Genotyping was performed by real-time PCR with TaqMan probes. Four ATV metabolizer phenotypes were found: slow, intermediate, normal and fast. Six gene polymorphisms, SLCO1B1-rs4149056, ABCB1-rs1045642, CYP2D6-rs1135840, CYP2B6-rs3745274, NAT2-rs1208, and COMT- rs4680, had a significant effect on ATV pharmacokinetics (P < 0.05). The polymorphisms in SLCO1B1 and ABCB1 seemed to have a greater effect and were especially important for the shift from an intermediate to a normal metabolizer. This is the first study that demonstrates how the interaction of genetic variants affect metabolic phenotyping and improves understanding of how SLCO1B1 and ABCB1 variants that affect statin metabolism may partially explain the variability in drug response. Notwithstanding, the influence of other genetic and non-genetic factors is not ruled out.",2020,The polymorphisms in SLCO1B1 and ABCB1 seemed to have a greater effect and were especially important for the shift from an intermediate to a normal metabolizer.,"['60 healthy Mexican men', 'Mexican population']","['Atorvastatin (ATV', 'ATV']","['ATV plasma levels', 'ATV pharmacokinetics']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",60.0,0.0262018,The polymorphisms in SLCO1B1 and ABCB1 seemed to have a greater effect and were especially important for the shift from an intermediate to a normal metabolizer.,"[{'ForeName': 'Rafael B R', 'Initials': 'RBR', 'LastName': 'León-Cachón', 'Affiliation': 'Center of Molecular Diagnostics and Personalized Medicine, Department of Basic Sciences, Division of Health Sciences, University of Monterrey, San Pedro Garza Garcia, Nuevo Leon, Mexico. rafael.reyesleon@udem.edu.'}, {'ForeName': 'Aileen-Diane', 'Initials': 'AD', 'LastName': 'Bamford', 'Affiliation': 'Center of Molecular Diagnostics and Personalized Medicine, Department of Basic Sciences, Division of Health Sciences, University of Monterrey, San Pedro Garza Garcia, Nuevo Leon, Mexico.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Meester', 'Affiliation': 'Center of Molecular Diagnostics and Personalized Medicine, Department of Basic Sciences, Division of Health Sciences, University of Monterrey, San Pedro Garza Garcia, Nuevo Leon, Mexico.'}, {'ForeName': 'Hugo Alberto', 'Initials': 'HA', 'LastName': 'Barrera-Saldaña', 'Affiliation': 'Vitagenesis S.A., Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Gómez-Silva', 'Affiliation': 'Forensic Medicine Service, School of Medicine, Autonomous University of Nuevo Leon, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'María F García', 'Initials': 'MFG', 'LastName': 'Bustos', 'Affiliation': 'Institute of Experimental Pathology (CONICET), Faculty of Health Sciences, National University of Salta, Salta, Argentina.'}]",Scientific reports,['10.1038/s41598-020-65843-y']
3307,32483139,The Haemodynamic Response to Endotracheal Intubation at Different Time of Fentanyl Given During Induction: A Randomised Controlled Trial.,"Endotracheal intubation elicits huge spectrum of stress responses which are hazardous in high-risk patients. Numerous drugs and techniques have been applied to attenuate the stress responses. In this double-blind study, one hundred and forty-five patients over 20 years old, ASA physical status I and II, undergoing elective surgeries requiring general anaesthesia with endotracheal intubation were included. Patients were randomly divided into three groups which fentanyl 2 mcg/kg was given at either 1, 2, 3 minutes before intubation. All groups received midazolam 0.05 mg/kg, lidocaine 0.5 mg/kg, propofol 2 mg/kg and rocuronium 1 mg/kg before intubation. Haemodynamic parameters were recorded for 10 minutes after induction. Two-level longitudinal hierarchical linear models were used for data interpretation and P < 0.05 was considered statistically significant. The study demonstrated significantly lower haemodynamic responses in the group who received fentanyl 2 minutes before intubation (P < 0.05). Confounding factors such as smoking, hypertension, diabetes mellitus and preoperative intravenous fluid supplement were analysed. In conclusion, fentanyl injection 2 minutes before intubation is recommended in order to obtain the most stable haemodynamic status.",2020,The study demonstrated significantly lower haemodynamic responses in the group who received fentanyl 2 minutes before intubation (P < 0.05).,"['one hundred and forty-five patients over 20 years old, ASA physical status I and II, undergoing elective surgeries requiring general anaesthesia with endotracheal intubation were included', 'high-risk patients']","['Fentanyl', 'midazolam 0.05\u2009mg/kg, lidocaine 0.5\u2009mg/kg, propofol 2\u2009mg/kg and rocuronium 1\u2009mg/kg before intubation', 'Endotracheal intubation']","['haemodynamic responses', 'Haemodynamic parameters']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",145.0,0.0873971,The study demonstrated significantly lower haemodynamic responses in the group who received fentanyl 2 minutes before intubation (P < 0.05).,"[{'ForeName': 'Cheng Yeon', 'Initials': 'CY', 'LastName': 'Teong', 'Affiliation': 'Department of Anesthesiology, MacKay Memorial Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chien-Chung', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, MacKay Memorial Hospital, Taipei, Taiwan, ROC. cchuang@dr.com.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'MacKay Junior College of Medicine, Nursing and Management College, Taipei, Taiwan, ROC.'}]",Scientific reports,['10.1038/s41598-020-65711-9']
3308,32483147,"Analysis of immune, microbiota and metabolome maturation in infants in a clinical trial of Lactobacillus paracasei CBA L74-fermented formula.","Mother's milk is the best choice for infants nutrition, however when it is not available or insufficient to satisfy the needs of the infant, formula is proposed as an effective substitute. Here, we report the results of a randomized controlled clinical trial (NCT03637894) designed to evaluate the effects of two different dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula) versus breastfeeding (reference group) on immune defense mechanisms (primary endpoint: secretory IgA, antimicrobial peptides), the microbiota and its metabolome (secondary outcomes), in healthy full term infants according to the type of delivery (n = 13/group). We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk. Metabolome analysis allowed us to distinguish subjects based on their dietary regimen and mode of delivery. Together, these results suggest that a fermented formula favors the maturation of the immune system, microbiota and metabolome.",2020,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.",['healthy full term infants according to the type of delivery (n\u2009=\u200913/group'],"['Lactobacillus paracasei CBA', 'dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula']","['secretory IgA', 'safe and well tolerated']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}]","[{'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}]",,0.03072,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Roggero', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy. paola.roggero@unimi.it.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Liotto', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pozzi', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Braga', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Troisi', 'Affiliation': 'Theoreo Srl, Via degli Ulivi 3, 84090, Montecorvino Pugliano, SA, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Menis', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria Lorella', 'Initials': 'ML', 'LastName': 'Giannì', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Berni Canani', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Paparo', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nocerino', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Budelli', 'Affiliation': 'School of Engineering, Niccoló Cusano University, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rescigno', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy. maria.rescigno@hunimed.eu.'}]",Nature communications,['10.1038/s41467-020-16582-1']
3309,32483161,Efficacy and safety of artemisinin-based combination therapy and the implications of Pfkelch13 and Pfcoronin molecular markers in treatment failure in Senegal.,"In 2006, Senegal adopted artemisinin-based combination therapy (ACT) as first-line treatment in the management of uncomplicated malaria. This study aimed to update the status of antimalarial efficacy more than ten years after their first introduction. This was a randomized, three-arm, open-label study to evaluate the efficacy and safety of artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP) in Senegal. Malaria suspected patients were screened, enrolled, treated, and followed for 28 days for AL and ASAQ arms or 42 days for DP arm. Clinical and parasitological responses were assessed following antimalarial treatment. Genotyping (msp1, msp2 and 24 SNP-based barcode) were done to differentiate recrudescence from re-infection; in case of PCR-confirmed treatment failure, Pfk13 propeller and Pfcoronin genes were sequenced. Data was entered and analyzed using the WHO Excel-based application. A total of 496 patients were enrolled. In Diourbel, PCR non-corrected/corrected adequate clinical and parasitological responses (ACPR) was 100.0% in both the AL and ASAQ arms. In Kedougou, PCR corrected ACPR values were 98.8%, 100% and 97.6% in AL, ASAQ and DP arms respectively. No Pfk13 or Pfcoronin mutations associated with artemisinin resistance were found. This study showed that AL, ASAQ and DP remain efficacious and well-tolerated in the treatment of uncomplicated P. falciparum malaria in Senegal.",2020,"This study showed that AL, ASAQ and DP remain efficacious and well-tolerated in the treatment of uncomplicated P. falciparum malaria in Senegal.","['treatment failure in Senegal', '496 patients were enrolled', 'Senegal', 'Malaria suspected patients were screened, enrolled, treated, and followed for 28 days for AL and ASAQ arms or 42 days for DP arm']","['Senegal adopted artemisinin-based combination therapy (ACT', 'artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP', 'artemisinin-based combination therapy']","['antimalarial efficacy', 'Clinical and parasitological responses', 'Efficacy and safety', 'PCR corrected ACPR values', 'efficacy and safety', 'PCR non-corrected/corrected adequate clinical and parasitological responses (ACPR']","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4750349', 'cui_str': 'Malaria suspected'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]",496.0,0.0471766,"This study showed that AL, ASAQ and DP remain efficacious and well-tolerated in the treatment of uncomplicated P. falciparum malaria in Senegal.","[{'ForeName': 'Mamadou Alpha', 'Initials': 'MA', 'LastName': 'Diallo', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal. mamadoualpha.diallo@ucad.edu.sn.'}, {'ForeName': 'Mamadou Samb', 'Initials': 'MS', 'LastName': 'Yade', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Yaye Die', 'Initials': 'YD', 'LastName': 'Ndiaye', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Ibrahima', 'Initials': 'I', 'LastName': 'Diallo', 'Affiliation': 'National Malaria Control Program (NMCP), Rue Aimé Césaire, Fann Résidence, Dakar, Senegal.'}, {'ForeName': 'Khadim', 'Initials': 'K', 'LastName': 'Diongue', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Saidou Abdoul', 'Initials': 'SA', 'LastName': 'Sy', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Mouhamad', 'Initials': 'M', 'LastName': 'Sy', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Mame Cheikh', 'Initials': 'MC', 'LastName': 'Seck', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Mouhamadou', 'Initials': 'M', 'LastName': 'Ndiaye', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Baba', 'Initials': 'B', 'LastName': 'Dieye', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Jules François', 'Initials': 'JF', 'LastName': 'Gomis', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Djiby', 'Initials': 'D', 'LastName': 'Sow', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Awa Bineta', 'Initials': 'AB', 'LastName': 'Dème', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Aida Sadikh', 'Initials': 'AS', 'LastName': 'Badiane', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Daouda', 'Initials': 'D', 'LastName': 'Ndiaye', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}]",Scientific reports,['10.1038/s41598-020-65553-5']
3310,32483186,The Help for Hay Fever community pharmacy-based pilot randomised controlled trial for intermittent allergic rhinitis.,"Management of intermittent allergic rhinitis (IAR) is suboptimal in the UK. An Australian community pharmacy-based intervention has been shown to help patients better self-manage their IAR. We conducted a pilot cluster RCT in 12 Scottish community pharmacies to assess transferability of the Australian intervention. Trained staff in intervention pharmacies delivered the intervention to eligible customers (n = 60). Non-intervention pharmacy participants (n = 65) received usual care. Outcome measures included effect size of change in the mini-Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) between baseline, 1-week and 6-week follow-up. Trial procedures were well received by pharmacy staff, and customer satisfaction with the intervention was high. The standardised effect size for miniRQLQ total score was -0.46 (95% CI, -1.05, 0.13) for all participants and -0.14 (95% CI,-0.86, 0.57) in the complete case analysis, suggesting a small overall treatment effect in the intervention group. A full-scale RCT is warranted to fully evaluate the effectiveness of this service.",2020,The standardised effect size for miniRQLQ total score was -0.46,"['12 Scottish community pharmacies to assess transferability of the Australian intervention', 'intermittent allergic rhinitis (IAR']",['usual care'],"['miniRQLQ total score', 'effect size of change in the mini-Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ']","[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]",[],"[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.163936,The standardised effect size for miniRQLQ total score was -0.46,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Porteous', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK. t.porteous@abdn.ac.uk.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bond', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'School of Health Sciences, City, University of London, Northampton Square, London, EC1V 0HB, UK.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Lee', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lowrie', 'Affiliation': 'Pharmacy Research and Development Team, Pharmacy and Prescribing Support Unit, West Glasgow Ambulatory Care Hospital, Glasgow, G3 8SJ, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Scotland', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Allergy and Respiratory Research Group, Centre for Medical Informatics, Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Teviot Place, Edinburgh, EH8 9AG, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, 27 Bute Gardens, Glasgow, G12 8RS, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Faculty of Pharmacy, Building A15, The University of Sydney, Camperdown, NSW, 2006, Australia.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-0180-4']
3311,32483272,Measuring Cancer Hallmark Mediation of the TET1 Glioma Survival Effect with Linked Neural-Network Based Mediation Experiments.,"This paper examines the effect of TET1 expression on survival in glioma patients using open-access data from the Genomic Data Commons. A neural network-based survival model was built on expression data from a selection of genes most affected by TET1 knockdown with a median cross-validated survival concordance of 82.5%. A synthetic experiment was then conducted that linked two separately trained neural networks: a multitask model estimating cancer hallmark gene expression from TET1 expression, and a survival neural network. This experiment quantified the mediation of the TET1 survival effect through eight cancer hallmarks: apoptosis, cell cycle, cell death, cell motility, DNA repair, immune response, two phosphorylation pathways, and a randomized gene sets. Immune response, DNA repair, and apoptosis displayed greater mediation than the randomized gene set. Cell motility was inversely associated with only 12.5% mediated concordance. We propose the neural network linkage mediation experiment as an approach to collecting evidence of hazard mediation relationships with prognostic capacity useful for designing interventions.",2020,A neural network-based survival model was built on expression data from a selection of genes most affected by TET1 knockdown with a median cross-validated survival concordance of 82.5%.,['glioma patients using open-access data from the Genomic Data Commons'],['TET1 expression'],['Cell motility'],"[{'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0205214', 'cui_str': 'Common'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0007608', 'cui_str': 'Motility, Cell'}]",,0.094776,A neural network-based survival model was built on expression data from a selection of genes most affected by TET1 knockdown with a median cross-validated survival concordance of 82.5%.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Luechtefeld', 'Affiliation': 'Insilica LLC, 2736 Quarry Heights Way, Baltimore, MD, USA.'}, {'ForeName': 'Nole', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': 'Insilica LLC, 2736 Quarry Heights Way, Baltimore, MD, USA.'}, {'ForeName': 'Channing', 'Initials': 'C', 'LastName': 'Paller', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kuhns', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Laterra', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Bressler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA. bressler@kennedykrieger.org.'}]",Scientific reports,['10.1038/s41598-020-65369-3']
3312,32483480,"Comparing the Effectiveness of Computer-Based, Manual-based, and Combined Cognitive Rehabilitation on Cognitive Functions in Relapsing-Remitting Multiple Sclerosis Patients.","Introduction
This study aimed to compare the effectiveness of computer-based, manual-based, and combined cognitive rehabilitation to improve cognitive functions among patients with Relapsing-Remitting Multiple Sclerosis (RRMS).
Methods
This was a quasi-experimental study with a pre-test-post-test, and a 2-month follow-up, as well as a control group design. Sixty female patients with RRMS were selected by convenience sampling technique. Then they were randomly assigned into three experimental groups (computer-based, manual-based, and combined cognitive rehabilitation, each group including 12 patients), a placebo group (12 patients), and a control group (12 patients). The interventions were conducted in 21 sessions for the experimental groups for 5 months. The placebo group received physical rehabilitation intervention, and the control group received no intervention. The study participants were assessed by Psychiatric-Neurological Profile, Mini-Mental State Examination, Kurtzke Expanded Disability Status Scale, Stroop Color and Word Test, Wisconsin Card Sorting Test, and Paced Auditory Serial Addition Test. The obtained data were analyzed by repeated-measures multivariate analysis of variance in SPSS.
Results
The effect of group factor was not significant (η 2 =0.129), but the effect of time (η 2 =0.884) and interaction effect of time and group (η 2 =0.295) were statistically significant (P<0.05). There was no significant difference between the effects of all three rehabilitation interventions (P>0.05). In the post-test totally and in Follow-up partially, all comparisons among three experimental groups with control and placebo groups were statistically significant (P<0.05).
Conclusion
Cognitive rehabilitation was effective in improving cognitive functions in patients with RRMS. Thus, these interventions are recommended for application, along with other treatment protocols to treat RRMS in clinical settings.",2020,There was no significant difference between the effects of all three rehabilitation interventions (P>0.05).,"['patients with Relapsing-Remitting Multiple Sclerosis (RRMS', 'Relapsing-Remitting Multiple Sclerosis Patients', 'Sixty female patients with RRMS', 'patients with RRMS']","['Computer-Based, Manual-based, and Combined Cognitive Rehabilitation', 'Cognitive rehabilitation', 'physical rehabilitation intervention, and the control group received no intervention', 'computer-based, manual-based, and combined cognitive rehabilitation', 'placebo']","['cognitive functions', 'Cognitive Functions', 'Psychiatric-Neurological Profile, Mini-Mental State Examination, Kurtzke Expanded Disability Status Scale, Stroop Color and Word Test, Wisconsin Card Sorting Test, and Paced Auditory Serial Addition Test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}]",60.0,0.0123961,There was no significant difference between the effects of all three rehabilitation interventions (P>0.05).,"[{'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Rahmani', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology and Educational Sciences, Semnan University, Mahdishahr, Semnan, Iran.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Rahimian Boogar', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology and Educational Sciences, Semnan University, Mahdishahr, Semnan, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Talepasand', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology and Educational Sciences, Semnan University, Mahdishahr, Semnan, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Nokani', 'Affiliation': 'Department of Clinical Psychology, Arak University of Medical Sciences, Arak, Iran.'}]",Basic and clinical neuroscience,['10.32598/bcn.9.10.430']
3313,32483481,Cognitive-Behavioral Therapy Versus Transcranial Direct Current Stimulation for Augmenting Selective Serotonin Reuptake Inhibitors in Obsessive-Compulsive Disorder Patients.,"Introduction
Obsessive-Compulsive Disorder (OCD) belongs to the categories of psychiatric disorders with the potential to turn into a chronic condition without receiving the necessary treatments. The main feature of OCD is the frequent or intense obsession and compulsion that might induce great pain and suffering in patients. Moreover, as one of the most prevalent abnormalities, depression usually follows OCD. The present study aimed to compare the effects of Exposure and Response Prevention (ERP) and Transcranial Direct Current Stimulation (tDCS) treatments adjunct to pharmacotherapy on decreasing the severity of obsession-depression symptoms and improving the quality of life in OCD patients.
Methods
This was a quasi-experimental study with a pre-test, post-test design and a follow-up stage. The statistical population comprised all the patients diagnosed with OCD in Zanjan Province, Iran. Besides, 26 OCD patients referring to Shahid Beheshti Medical Center in Zanjan were selected using a purposive sampling method. Then, they were randomly assigned to two treatment groups. The study subjects completed the Yale Brown Obsessive-Compulsive Scale (Y-BOCS), Beck Depression Inventory-II (BDI 2), and the Quality of Life Questionnaire at the pre-treatment, post-treatment, and follow-up stages (1 month and 2 months after the treatment). Analysis of Covariance (ANCOVA) and Reliable Change Index (RCI) methods were used to measure statistical and clinical significances, respectively. The collected data were analyzed using SPSS.
Results
The obtained data suggested no significant difference between the ERP and tDCS groups concerning the symptoms of OCD and depression at the post-test stage (P>0.05). Conversely, in terms of life quality, there was a significant difference between the ERP and tDCS groups at the post-test phase (P<0.05).
Conclusion
Although the present findings revealed no statistically significant difference between the ERP and tDCS groups (except for the quality of life variable), the pharmacotherapy-ERP combination proved to be more effective than pharmaco therapy-tDCS in treating OCD patients.",2020,"Although the present findings revealed no statistically significant difference between the ERP and tDCS groups (except for the quality of life variable), the pharmacotherapy-ERP combination proved to be more effective than pharmaco therapy-tDCS in treating OCD patients.","['26 OCD patients referring to Shahid Beheshti Medical Center in Zanjan', 'OCD patients', 'patients diagnosed with OCD in Zanjan Province, Iran', 'Obsessive-Compulsive Disorder Patients']","['Cognitive-Behavioral Therapy Versus Transcranial Direct Current Stimulation', 'Exposure and Response Prevention (ERP) and Transcranial Direct Current Stimulation (tDCS']","['quality of life', 'Analysis of Covariance (ANCOVA) and Reliable Change Index', 'symptoms of OCD and depression', 'life quality', 'Yale Brown Obsessive-Compulsive Scale (Y-BOCS), Beck Depression Inventory-II (BDI 2), and the Quality of Life Questionnaire', 'severity of obsession-depression symptoms']","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",26.0,0.0240093,"Although the present findings revealed no statistically significant difference between the ERP and tDCS groups (except for the quality of life variable), the pharmacotherapy-ERP combination proved to be more effective than pharmaco therapy-tDCS in treating OCD patients.","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Dadashi', 'Affiliation': 'Department of Clinical Psychology, Social Determinants of Health Research Center, University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Yousefi Asl', 'Affiliation': 'Department of Psychology, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Morsali', 'Affiliation': 'Department of Psychology, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Basic and clinical neuroscience,['10.32598/bcn.11.1.13333.2']
3314,32483675,Medical management of pediatric glaucoma: lessons learned from randomized clinical trials.,"PURPOSE
To critically discuss the randomized clinical trials (RCTs) on glaucoma medical therapy for the management of pediatric glaucoma.
METHODS
RCTs on glaucoma drugs carried out on pediatric subjects with ocular hypertension and glaucoma were identified through systematic searches. The methods of the RCTs and the safety and the efficacy of the glaucoma drugs were reviewed and discussed.
RESULTS
We included five RCTs. One study compared dorzolamide with 0.5% timolol gel; one brinzolamide with 0.5% levobetaxolol; one 0.25% betaxolol, 0.25% timolol gel, and 0.5% timolol gel; one latanoprost with 0.5% timolol; and one travoprost with 0.5% timolol. The primary outcome was safety for two studies and efficacy for three studies. None of the RCTs was powered to detect statistically significant differences in intraocular pressure (IOP) between treatments. In total, 658 subjects received at least one dose of study medication. Beta-blockers were administered to 359 patients, carbonic anhydrase inhibitor (CAI) to 154, and prostaglandins to 145 patients. IOP-lowering efficacy ranged from 20 to 23% for CAI, from 9 to 36% for beta-blockers, and from 26 to 27% for prostaglandins. The percentage of responders was 50% for CAI, ranged from 38 to 74% for beta-blockers and from 60 to 83% for prostaglandins. Two patients receiving timolol experienced a systemic, drug-related serious adverse event (one patient bradycardia and one pneumonia). Systemic, nonserious drug-related events occurred in 15 patients randomized to beta-blockers and in 8 patients randomized to CAI. No adverse events occurred in children treated with prostaglandins.
CONCLUSION
RCTs that are available on medical therapy for glaucoma are few and underpowered. The proportion of responders is lower in children; however, in subjects who are responders, the efficacy of glaucoma drugs seemed to be comparable to that in adults. As systemic adverse events have been reported, including serious events with timolol, a particular attempt to minimize the absorption of the drug (using the lowest dose and the gel formulation of beta-blockers or considering the lacrimal punctum occlusion) and a follow-up that is more frequent and more focused on safety should be considered in pediatric subjects who are on topical glaucoma medications.",2020,"IOP-lowering efficacy ranged from 20 to 23% for CAI, from 9 to 36% for beta-blockers, and from 26 to 27% for prostaglandins.","['pediatric subjects who are on topical glaucoma medications', 'pediatric glaucoma', '359 patients', '658 subjects received at least one dose of study medication', 'pediatric subjects with ocular hypertension and glaucoma']","['betaxolol, 0.25% timolol gel, and 0.5% timolol gel; one latanoprost with 0.5% timolol', 'CAI', 'Beta-blockers', 'timolol gel; one brinzolamide with 0.5% levobetaxolol', 'glaucoma medical therapy', 'carbonic anhydrase inhibitor (CAI', 'timolol', 'dorzolamide']","['intraocular pressure (IOP', 'IOP-lowering efficacy', 'adverse events', 'systemic, drug-related serious adverse event (one patient bradycardia and one pneumonia']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2981140', 'cui_str': 'Glaucoma of childhood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}]","[{'cui': 'C0005320', 'cui_str': 'Betaxolol'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0007036', 'cui_str': 'Carbonic anhydrase inhibitor'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0673966', 'cui_str': 'brinzolamide'}, {'cui': 'C1171274', 'cui_str': 'Levobetaxolol'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0165590', 'cui_str': 'dorzolamide'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",658.0,0.0368441,"IOP-lowering efficacy ranged from 20 to 23% for CAI, from 9 to 36% for beta-blockers, and from 26 to 27% for prostaglandins.","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Sacchi', 'Affiliation': 'University Eye Clinic, San Giuseppe Hospital, University of Milan, Via San Vittore 12, 20123, Milan, Italy. matteosacchi.hsg@gmail.com.'}, {'ForeName': 'Rosario Alfio Umberto', 'Initials': 'RAU', 'LastName': 'Lizzio', 'Affiliation': 'University Eye Clinic, San Giuseppe Hospital, University of Milan, Via San Vittore 12, 20123, Milan, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Villani', 'Affiliation': 'University Eye Clinic, San Giuseppe Hospital, University of Milan, Via San Vittore 12, 20123, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Monsellato', 'Affiliation': 'University Eye Clinic, San Giuseppe Hospital, University of Milan, Via San Vittore 12, 20123, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Lucentini', 'Affiliation': 'University Eye Clinic, San Giuseppe Hospital, University of Milan, Via San Vittore 12, 20123, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cremonesi', 'Affiliation': 'University Eye Clinic, San Giuseppe Hospital, University of Milan, Via San Vittore 12, 20123, Milan, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Luccarelli', 'Affiliation': 'University Eye Clinic, San Giuseppe Hospital, University of Milan, Via San Vittore 12, 20123, Milan, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Serafino', 'Affiliation': 'University Eye Clinic, San Giuseppe Hospital, University of Milan, Via San Vittore 12, 20123, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nucci', 'Affiliation': 'University Eye Clinic, San Giuseppe Hospital, University of Milan, Via San Vittore 12, 20123, Milan, Italy.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04767-9']
3315,32483678,Treatment of avascular osteonecrosis of femoral head by core decompression and platelet-rich plasma: a prospective not controlled study.,"PURPOSE
Core decompression is a surgical option since the 1960s for hip osteonecrosis treatment. This technique promotes bone repair by reducing intramedullary pressure, but this is not often enough to stop the progression of necrosis. The aim of this study was to associate core decompression with the regenerative stimulus provided by platelet-rich plasma (PRP) and compare our results with other regenerative techniques.
METHODS
Femoral head osteonecrosis was prospectively evaluated in 30 hips (22 patients, 15-60 years) treated by core decompression and PRP graft. Patients presented monolateral or bilateral osteonecrosis in stage I-IIA-IIB according to Arlet and Ficat classification. The outcome was assessed by changes in Harris Hip Score (HHS) and the need for total hip replacement (THA).
RESULTS
The mean preoperative HHS was 64 points, at two years from surgery was roughly 84 points. Sixteen of 30 hips showed osteonecrosis progression of the femoral head and were converted to THA. At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively.
CONCLUSION
Core decompression combined with PRP could be indicated as a treatment for the I and IIA stages of osteonecrosis, as it significantly reduces joint pain and delays THA. This procedure should be avoided in AVNFH related to cortisone therapy because only a few benefits have been proven. It also has the advantage of being technically simple, minimally invasive, and free from complications.",2020,"At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively.
","['avascular osteonecrosis of femoral head by core decompression and platelet-rich plasma', 'Femoral head osteonecrosis was prospectively evaluated in 30 hips (22 patients, 15-60\xa0years) treated by core decompression and PRP graft', 'Patients presented monolateral or bilateral osteonecrosis in stage I-IIA-IIB according to Arlet and Ficat classification']",['PRP'],"['Harris Hip Score (HHS) and the need for total hip replacement (THA', 'osteonecrosis progression', 'mean preoperative HHS', 'joint pain and delays THA', 'survival rate']","[{'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0353426,"At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Grassi', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy. marco.grassi7@gmail.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Salari', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Massetti', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Giuseppe F', 'Initials': 'GF', 'LastName': 'Papalia', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gigante', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}]",International orthopaedics,['10.1007/s00264-020-04628-4']
3316,32483770,Differential Osteoprotegerin Kinetics after Stimulation with Desmopressin and Lipopolysaccharides In Vivo.,"Osteoprotegerin (OPG) regulates bone metabolism by reducing the activation of osteoclasts, but may also be involved in blood vessel calcification and atherosclerosis. Within endothelial cells OPG is stored in Weibel-Palade bodies (WPBs). Blood kinetics of OPG are essentially unknown. We aimed to assess these using two distinct in vivo models; one after stimulation with desmopressin (DDAVP) and another after stimulation with lipopolysaccharide (LPS). Both clinical trials were conducted at the Department of Clinical Pharmacology at the Medical University of Vienna, Austria. Participants received desmopressin (0.3 µg/kg), LPS (2 ng/kg), or placebo (sodium chloride 0.9%) with subsequent blood sampling at time points up to 24 hours after administration. The primary objective of this study was to investigate the plasma kinetics of OPG after stimulation with desmopressin and LPS. Secondary analyses included the release of other WPB contents including von Willebrand factor (vWF). This analysis included 31 healthy volunteers ( n = 16 for desmopressin and placebo, n = 15 for LPS). Infusion of desmopressin did not increase OPG concentrations compared with placebo, while LPS infusion significantly increased OPG levels, both compared with desmopressin ( p < 0.0001) and to placebo ( p = 0.004), with a maximum of ∼twofold increase in OPG levels ∼6 hours after infusion. von Willebrand factor levels increased after both desmopressin and LPS infusion ( p < 0.0001), with a maximum of ∼threefold increase 2 hours after desmopressin and a maximum of ∼twofold increase 6 hours after LPS administration. In conclusion, we report that, in contrast to vWF, OPG is not released upon stimulation with desmopressin, but increases significantly during experimental endotoxemia.",2020,"von Willebrand factor levels increased after both desmopressin and LPS infusion ( p < 0.0001), with a maximum of ∼threefold increase 2 hours after desmopressin and a maximum of ∼twofold increase 6 hours after LPS administration.","[' n \u2009=\u200915 for LPS', '31 healthy volunteers ( n \u2009=\u200916 for']","['desmopressin (DDAVP', 'LPS', 'placebo (sodium chloride 0.9%) with subsequent blood sampling', 'Osteoprotegerin (OPG', 'desmopressin and LPS', 'lipopolysaccharide (LPS', 'desmopressin and placebo', 'Desmopressin and Lipopolysaccharides', 'desmopressin', 'placebo']","['OPG levels', 'Blood kinetics of OPG', 'von Willebrand factor levels', 'OPG levels ∼6', 'release of other WPB contents including von Willebrand factor (vWF', 'OPG concentrations', 'plasma kinetics of OPG', 'Differential Osteoprotegerin Kinetics']","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0701195', 'cui_str': 'Desmospray'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}]","[{'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0443199', 'cui_str': 'Differential'}]",31.0,0.0957707,"von Willebrand factor levels increased after both desmopressin and LPS infusion ( p < 0.0001), with a maximum of ∼threefold increase 2 hours after desmopressin and a maximum of ∼twofold increase 6 hours after LPS administration.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Buchtele', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Katarina D', 'Initials': 'KD', 'LastName': 'Kovacevic', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brostjan', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwameis', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Hayden', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Derhaschnig', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Firbas', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schoergenhofer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1712448']
3317,32483847,Efficacy of prucalopride in critically ill patients with paralytic ileus; a pilot randomized double-blind placebo controlled trial.,"BACKGROUND
Paralytic ileus is a common intestinal dysfunction in critically ill patients, which results in complications and poor hospital outcomes. There are still no established effective medications, except correcting the primary causes and prokinetics trial, which have limited efficacy and potential adverse events.
AIMS
To evaluate the efficacy of prucalopride on paralytic ileus in critically ill patients.
METHODS
A randomized, double-blind, placebo-controlled trial of 5 consecutive days treatment periods was conducted. Critically ill patients with paralytic ileus were included. The primary endpoint was the improvement of bowel dilatation on plain abdominal radiography. The secondary endpoints were the change of abdominal circumference.
RESULTS
Twenty patients were consecutively enrolled in the study. There was no significant difference in baseline characteristics of patients. The common causes of hospitalization were infection and respiratory problems. The maximum large bowel diameters dramatically decreased in prucalopride group and reached maximum point on the 3 rd day after intervention when compared with placebo [-2.1 (+1.8) vs. 0.3 (+1.5) cm, p = 0.01]. The maximum small bowel diameters were noticeably less decreased and were not significantly different when compared to placebo. The abdominal circumferences notably decreased and significantly diverged from placebo on the 3rd day.
CONCLUSIONS
Prucalopride was an effective enterokinetic agent to improve non-severe inflammatory or ischemic bowel conditions related paralytic ileus in critically ill patients. Its effect was predominant on large intestine, but could not be well demonstrated on small bowel in this study. Future study or concomitant other prokinetics for upper gut motility should be further evaluated.",2020,"CONCLUSIONS
Prucalopride was an effective enterokinetic agent to improve non-severe inflammatory or ischemic bowel conditions related paralytic ileus in critically ill patients.","['Twenty patients were consecutively enrolled in the study', 'critically ill patients', 'Critically ill patients with paralytic ileus', 'critically ill patients with paralytic ileus']","['prucalopride', 'placebo']","['maximum large bowel diameters', 'paralytic ileus', 'improvement of bowel dilatation on plain abdominal radiography', 'abdominal circumferences', 'maximum small bowel diameters', 'change of abdominal circumference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030446', 'cui_str': 'Paralytic ileus'}]","[{'cui': 'C0913506', 'cui_str': 'prucalopride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0021851', 'cui_str': 'Structure of large intestine'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0030446', 'cui_str': 'Paralytic ileus'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0034573', 'cui_str': 'Diagnostic radiography of abdomen'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.682667,"CONCLUSIONS
Prucalopride was an effective enterokinetic agent to improve non-severe inflammatory or ischemic bowel conditions related paralytic ileus in critically ill patients.","[{'ForeName': 'Sawangpong', 'Initials': 'S', 'LastName': 'Jandee', 'Affiliation': 'Gastroenterology and Hepatology Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Wetwittayakhlang', 'Affiliation': 'Gastroenterology and Hepatology Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Pattira', 'Initials': 'P', 'LastName': 'Boonsri', 'Affiliation': 'Diagnostic Radiology Unit, Division of Radiology, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15127']
3318,32483939,Umbilical closure using 2-octyl cyanoacrylate in transumbilical laparoscopic adrenalectomy: A randomized controlled trial.,"OBJECTIVES
To evaluate postoperative pain and esthetic outcomes in patients undergoing transumbilical laparoscopic adrenalectomy with wound closure using 2-octyl cyanoacrylate.
METHODS
A total of 26 patients who underwent laparoscopic adrenalectomy with the transumbilical approach and agreed to participate in this study were included. Patients were randomly divided into two groups: the 2-octyl cyanoacrylate group (Glue group) or the non-use group (non-Glue group). A single surgeon (AM) carried out all procedures between 2014 and 2017.
RESULTS
There were no significant differences in the clinical background of the Glue and non-Glue groups. The number of patients with moderate or high levels of pain in the resting/moving period on postoperative days 1, 2 and 3 was 6/10 (46%/77%), 6/9 (46%/69%) and 3/5 (23%/38%) in the non-Glue group, and 5/7 (38%/54%), 2/7 (15%/54%) and 1/3 (8%/23%) in the Glue group. These differences were not significant. In the subgroup analysis of patients aged <50 years, the numbers were 4/6 (57%/86%), 5/7 (71%/100%) and 3/5 (43%/71%) in the non-Glue group, and 3/4 (33%/44%), 1/4 (11%/44%) and 0/1 (0%/11%) in the Glue group in the resting/moving period. On postoperative days 2 and 3, these differences were significant (P = 0.035 and 0.037 in the resting period, and P = 0.017 and 0.013 in the moving period).
CONCLUSIONS
2-octyl cyanoacrylate can be used safely for laparoscopic adrenalectomy with the transumbilical approach, and might be useful for reducing postoperative pain in patients aged <50 years.",2020,"On postoperative days 2 and 3, these differences were significant (P = 0.035 and 0.037 in the resting period, and P = 0.017 and 0.013 in the moving period).
","['26 patients who underwent', 'patients aged <50\xa0years', 'patients undergoing transumbilical', 'transumbilical laparoscopic adrenalectomy']","['2-octyl cyanoacrylate group (Glue group) or the non-use group (non-Glue group', 'laparoscopic adrenalectomy with the transumbilical approach', 'Umbilical closure using 2-octyl cyanoacrylate', 'laparoscopic adrenalectomy with wound closure using 2-octyl cyanoacrylate']","['postoperative pain and esthetic outcomes', 'number of patients with moderate or high levels of pain', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0457793', 'cui_str': 'Transumbilical'}, {'cui': 'C0521267', 'cui_str': 'Laparoscopic adrenalectomy'}]","[{'cui': 'C0391770', 'cui_str': '2-octyl cyanoacrylate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0521267', 'cui_str': 'Laparoscopic adrenalectomy'}, {'cui': 'C0457793', 'cui_str': 'Transumbilical'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",26.0,0.050219,"On postoperative days 2 and 3, these differences were significant (P = 0.035 and 0.037 in the resting period, and P = 0.017 and 0.013 in the moving period).
","[{'ForeName': 'Keishiro', 'Initials': 'K', 'LastName': 'Fukumoto', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Miyajima', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Niwa', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hongo', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Kurihara', 'Affiliation': 'Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Oya', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14270']
3319,32483957,The preemptive effect of tramadol and metamizole on the intensity of postoperative pain.,"Aim To demonstrate the analgesic effect of preemptively administered tramadol and metamizole on the postoperative pain severity, after an elective operative hysterectomy with adnexectomy. Methods There were three groups with 30 patients in each group. Patients included in the study were between 45 to 67 years old. They were all in the ASA group II. Randomization was performed in random order according to the regular elective operating program. Patients in Group I received i. m. tramadol 1mg/kg, and in Group II 30mg/kg of metamizole, five minutes before anaesthesia induction. Patients did not receive preemptive analgesia in Group III (control). All patients underwent the same induction anaesthesiology procedure with propofol, fentanyl, tracrium, supplemented with O2, N2O, and sevoflurane at an appropriate dose until MAC 1 was reached. Surgeries lasted for 80-120 minutes. Every patient performed a resting pain assessment 30 minutes after an extubation by Numerical Pain Scale (NPS). Results We found out that tramadol had a better effect in preemptive analgesia and that the average pain score for Group I was 6.10 (p=0.043). In Group II, it was 7.93 (p=0.022). There is significant difference in pain intensity between patients in the control group, (pain intensity was 9.16), and those who received tramadol and metamizole. There was no significant difference in the intensity of pain when using these two analgesics (p=0.733). Conclusion The effect of preemptively administered tramadol prior to the introduction of general anaesthesia in postoperative pain is significantly more favourable than the effect of metamizole.",2020,There was no significant difference in the intensity of pain when using these two analgesics (p=0.733).,"['Patients included in the study were between 45 to 67 years old', 'elective operative hysterectomy with adnexectomy']","['tramadol and metamizole', 'propofol, fentanyl, tracrium, supplemented with O2, N2O, and sevoflurane', 'preemptive analgesia', 'tramadol']","['pain intensity', 'analgesic effect', 'postoperative pain severity', 'preemptive analgesia', 'intensity of postoperative pain', 'intensity of pain', 'average pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0036132', 'cui_str': 'Salpingo-oophorectomy'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0012586', 'cui_str': 'Dipyrone'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0592193', 'cui_str': 'Tracrium'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0268795,There was no significant difference in the intensity of pain when using these two analgesics (p=0.733).,"[{'ForeName': 'Ismet', 'Initials': 'I', 'LastName': 'Suljević', 'Affiliation': 'Clinic for Anaesthesia and Resuscitation, Clinical Centre of University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Muamer', 'Initials': 'M', 'LastName': 'Hadžiavdić', 'Affiliation': 'Clinic for Bone Surgery, Clinical Centre of University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Ismana', 'Initials': 'I', 'LastName': 'Šurković', 'Affiliation': 'Department for Endocrinology, Diabetes, and Diseases of Metabolism, Clinical Centre of University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Suljević', 'Affiliation': 'Sarajevo Health Centre, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Maida', 'Initials': 'M', 'LastName': 'Turan', 'Affiliation': 'Healthcare Group Acibadem, Representative Office in Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Ehlimana', 'Initials': 'E', 'LastName': 'Mušija', 'Affiliation': 'Clinic for Heart Diseases and Rheumatism, Clinical Centre of University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}]","Medicinski glasnik : official publication of the Medical Association of Zenica-Doboj Canton, Bosnia and Herzegovina",['10.17392/1118-20']
3320,32483981,Results of the first prospective-randomized trial on the peritoneal interposition flap in the prevention of postoperative lymphoceles.,is not required.,2020,is not required.,[],['peritoneal interposition flap'],['postoperative lymphoceles'],[],"[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C1998084', 'cui_str': 'Lymphocele after surgical procedure'}]",,0.0364542,is not required.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lenart', 'Affiliation': 'St. John of God Hospital Vienna, Krankenhaus der Barmherzigen Brüder Wien, Department of Urology, Vienna, Austria; sebastian.lenart@gmx.at.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'May', 'Affiliation': 'St. Elisabeth Hospital Straubing, Department of Urology, St. Elisabeth-Str. 23, 94315 Straubing, Germany, Straubing, Germany, 94315; matthias.may@klinikum-straubing.de.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': 'Caritas St. Josef Medical Centre, University of Regensburg, Department of Urology, Regensburg, Germany; maximilianburger@me.com.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bründl', 'Affiliation': 'University of Regensburg, Caritas-Krankenhaus St. Josef, Department of Urology, Regensburg, Germany; johannes.bruendl@gmail.com.'}]",Journal of endourology,['10.1089/end.2020.0467']
3321,32484068,Effects of Neurocognitive Temporal Training on Weapon Firing Performance.,"While marksmanship is a critical skill for military personnel, some service members experience difficulty in attaining and maintaining marksmanship qualifications. Temporal training may improve marksmanship performance, since rhythm and timing are critical for coordinated movement. In this study, we examined the effect of neurocognitive temporal training (NTT) on military personnel's marksmanship performance. We randomly assigned 41 active duty U.S. Army service members with prior marksmanship training into an NTT group that received 12 NTT training sessions ( N = 18) and a Control group ( N = 23) that received no NTT training. We measured marksmanship at baseline (pretest) and following either NTT (posttest) or, for the Control group, a comparable time period. We quantified marksmanship during 2 tasks of firing 5 self-paced shots at stationary 175 m and 300 m targets (Task 1) and firing at 50 moving and stationary targets of varying distances (Task 2). We recorded three measures of accuracy and three measures of precision (including Total Path Length, a unique measure quantifying shot-to-shot variability) for the first task, and we recorded one accuracy measure for the second task. To determine group differences for pretest versus posttest, we used multivariate analysis of variances for Task 1 and a mixed-model analysis of variance for Task 2. Results revealed significantly reduced variability and improved precision when firing at the 175 m target for the NTT group compared with the Control group ( p < .05), but there were no significant group differences on other measures. While these results suggest the utility of neurocognitive timing and rhythm training for marksmanship precision, additional research is needed and should include varied training regimens, comparisons of expert versus novice shooters, additional outcome measures, and a larger participant sample.",2020,"Results revealed significantly reduced variability and improved precision when firing at the 175 m target for the NTT group compared with the Control group ( p < .05), but there were no significant group differences on other measures.","[""military personnel's marksmanship performance"", '41 active duty U.S. Army service members with prior']","['marksmanship training into an NTT group that received 12 NTT training sessions ( N \u2009=\u200918) and a Control group ( N \u2009=\u200923) that received no NTT training', 'Temporal training', 'neurocognitive temporal training (NTT', 'Neurocognitive Temporal Training']","['Weapon Firing Performance', 'variability and improved precision', 'precision (including Total Path Length, a unique measure quantifying shot-to-shot variability']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0336663', 'cui_str': 'Instrument of aggression'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",41.0,0.0252952,"Results revealed significantly reduced variability and improved precision when firing at the 175 m target for the NTT group compared with the Control group ( p < .05), but there were no significant group differences on other measures.","[{'ForeName': 'Leah R', 'Initials': 'LR', 'LastName': 'Enders', 'Affiliation': 'DCS Corporation, Alexandria, Virginia, United States.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Boykin', 'Affiliation': 'Army Research Laboratory, San Antonio, Texas, United States.'}, {'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'Rice', 'Affiliation': 'Army Research Laboratory, San Antonio, Texas, United States.'}]",Perceptual and motor skills,['10.1177/0031512520927508']
3322,32484259,Repositioning for pressure injury prevention in adults.,"BACKGROUND
A pressure injury (PI), also referred to as a 'pressure ulcer', or 'bedsore', is an area of localised tissue damage caused by unrelieved pressure, friction, or shearing on any part of the body. Immobility is a major risk factor and manual repositioning a common prevention strategy. This is an update of a review first published in 2014.
OBJECTIVES
To assess the clinical and cost effectiveness of repositioning regimens(i.e. repositioning schedules and patient positions) on the prevention of PI in adults regardless of risk in any setting.
SEARCH METHODS
We searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus on 12 February 2019. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.
SELECTION CRITERIA
Randomised controlled trials (RCTs), including cluster-randomised trials (c-RCTs), published or unpublished, that assessed the effects of any repositioning schedule or different patient positions and measured PI incidence in adults in any setting.
DATA COLLECTION AND ANALYSIS
Three review authors independently performed study selection, 'Risk of bias' assessment, and data extraction. We assessed the certainty of the evidence using GRADE.
MAIN RESULTS
We identified five additional trials and one economic substudy in this update, resulting in the inclusion of a total of eight trials involving 3941 participants from acute and long-term care settings and two economic substudies in the review. Six studies reported the proportion of participants developing PI of any stage. Two of the eight trials reported within-trial cost evaluations. Follow-up periods were short (24 hours to 21 days). All studies were at high risk of bias. Funding sources were reported in five trials. Primary outcomes: proportion of new PI of any stage Repositioning frequencies: three trials compared different repositioning frequencies We pooled data from three trials (1074 participants) comparing 2-hourly with 4-hourly repositioning frequencies (fixed-effect; I² = 45%; pooled risk ratio (RR) 1.06, 95% confidence interval (CI) 0.80 to 1.41). It is uncertain whether 2-hourly repositioning compared with 4-hourly repositioning used in conjunction with any support surface increases or decreases the incidence of PI. The certainty of the evidence is very low due to high risk of bias, downgraded twice for risk of bias, and once for imprecision. One of these trials had three arms (967 participants) comparing 2-hourly, 3-hourly, and 4-hourly repositioning regimens on high-density mattresses; data for one comparison was included in the pooled analysis. Another comparison was based on 2-hourly versus 3-hourly repositioning. The RR for PI incidence was 4.06 (95% CI 0.87 to 18.98). The third study comparison was based on 3-hourly versus 4-hourly repositioning (RR 0.20, 95% CI 0.04 to 0.92). The certainty of the evidence is low due to risk of bias and imprecision. In one c-RCT, 262 participants in 32 ward clusters were randomised between 2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses. The RR for PI with 2-hourly repositioning compared with 3-hourly repositioning on standard mattress is imprecise (RR 0.90, 95% CI 0.69 to 1.16; very low-certainty evidence). The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02). The certainty of the evidence is very low, downgraded twice due to high risk of bias, and once for imprecision. Positioning regimens: four trials compared different tilt positions We pooled data from two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69%). There was no clear difference in the incidence of stage 1 or 2 PI. The effect of tilt is uncertain because the certainty of evidence is very low (pooled RR 0.62, 95% CI 0.10 to 3.97), downgraded due to serious design limitations and very serious imprecision. One trial involving 120 participants compared 30° tilt and 45° tilt with 'usual care' and reported no occurrence of PI events (low certainty evidence). Another trial involving 116 ICU patients compared prone with the usual supine positioning for PI. Reporting was incomplete and this is low certainty evidence. Secondary outcomes No studies reported health-related quality of life utility scores, procedural pain, or patient satisfaction. Cost analysis Two included trials also performed economic analyses. A cost-minimisation analysis compared the costs of 3-hourly and 4-hourly repositioning with 2-hourly repositioning schedule amongst nursing home residents. The cost of repositioning was estimated at CAD 11.05 and CAD 16.74 less per resident per day for the 3-hourly or 4-hourly regimen, respectively, compared with the 2-hourly regimen. The estimates of economic benefit were driven mostly by the value of freed nursing time. The analysis assumed that 2-, 3-, or 4-hourly repositioning is associated with a similar incidence of PI, as no difference in incidence was observed. A second study compared the nursing time cost of 3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation) amongst nursing home residents. The intervention was reported to be cost-saving compared with standard care (nursing time cost per patient EUR 206.60 versus EUR 253.10, incremental difference EUR -46.50, 95% CI EUR -1.25 to EUR -74.60).
AUTHORS' CONCLUSIONS
Despite the addition of five trials, the results of this update are consistent with our earlier review, with the evidence judged to be of low or very low certainty. There remains a lack of robust evaluations of repositioning frequency and positioning for PI prevention and uncertainty about their effectiveness. Since all comparisons were underpowered, there is a high level of uncertainty in the evidence base. Given the limited data from economic evaluations, it remains unclear whether repositioning every three hours using the 30° tilt versus ""usual care"" (90° tilt) or repositioning 3-to-4-hourly versus 2-hourly is less costly relative to nursing time.",2020,"The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02).","[""120 participants compared 30° tilt and 45° tilt with 'usual care' and reported no occurrence of PI events (low certainty evidence"", '3941 participants from acute and long-term care settings and two economic substudies in the review', '262 participants in 32 ward clusters', 'adults', 'adults in any setting', 'nursing home residents', 'adults regardless of risk in any setting', 'two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69', '116 ICU patients']","['2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses', '3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation', 'tilt positions']","['health-related quality of life utility scores, procedural pain, or patient satisfaction', 'cost of repositioning', 'Cost analysis', 'incidence of stage 1 or 2 PI', 'proportion of new PI of any stage Repositioning frequencies', 'cost-saving', 'RR for PI incidence', 'incidence of PI']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0585322', 'cui_str': 'Every two hours'}, {'cui': 'C0585323', 'cui_str': 'Every three hours'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0010171', 'cui_str': 'Analysis, Cost'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",116.0,0.24709,"The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02).","[{'ForeName': 'Brigid M', 'Initials': 'BM', 'LastName': 'Gillespie', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Walker', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Latimer', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Lukman', 'Initials': 'L', 'LastName': 'Thalib', 'Affiliation': 'Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Whitty', 'Affiliation': 'Health Economics Group, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McInnes', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Australia Sydney, St Vincent's Hospital Melbourne & Australian Catholic University, Fitzroy, Melbourne, Australia.""}, {'ForeName': 'Wendy P', 'Initials': 'WP', 'LastName': 'Chaboyer', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009958.pub3']
3323,30793642,"Safety and tolerability of anifrolumab, a monoclonal antibody targeting type I interferon receptor, in Japanese patients with systemic lupus erythematosus: A multicenter, phase 2, open-label study.","Objectives: This study evaluated the safety and tolerability of anifrolumab, a monoclonal antibody targeting the type I interferon (IFN) receptor, in Japanese patients with moderate-to-severe systemic lupus erythematosus (SLE). Methods: In this open-label, phase 2, dose-escalation study, patients received intravenous (IV) anifrolumab 100, 300, or 1000 mg every 4 weeks from days 29 to 337 (Stage 1). Patients who completed Stage 1 continued anifrolumab 300 mg every 4 weeks for 156 weeks (Stage 2). The primary objective was to evaluate the safety of anifrolumab for 48 weeks (Stage 1) and 156 weeks (Stage 2). The pharmacokinetics and pharmacodynamics of anifrolumab were also assessed. Results: Of 20 patients enrolled in Stage 1, 17 received IV anifrolumab 100 mg ( n = 6), 300 mg ( n = 5), or 1000 mg ( n = 6). Adverse events (AE) and serious AE (SAE) incidences were similar between dose cohorts. SAEs occurred in 41% (Stage 1) and 33% (Stage 2) of patients; AEs leading to discontinuation occurred in 24% (Stage 1) and 22% (Stage 2) of patients. Anifrolumab had non-linear pharmacokinetics after the first and last dose and dose-dependently suppressed the IFN gene signature. Conclusion: Anifrolumab was well tolerated among Japanese patients with moderate-to-severe SLE.",2020,SAEs occurred in 41% (Stage 1) and 33% (Stage 2) of patients; AEs leading to discontinuation occurred in 24% (Stage 1) and 22% (Stage 2) of patients.,"['20 patients enrolled in Stage 1, 17 received', 'Japanese patients with systemic lupus erythematosus', 'Japanese patients with moderate-to-severe SLE', 'Japanese patients with moderate-to-severe systemic lupus erythematosus (SLE']","['intravenous (IV) anifrolumab', 'IV anifrolumab', 'anifrolumab, a monoclonal antibody targeting type', 'anifrolumab, a monoclonal antibody targeting the type I interferon (IFN) receptor']","['Safety and tolerability', 'safety and tolerability', 'Adverse events (AE) and serious AE (SAE) incidences', 'SAEs', 'AEs leading to discontinuation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4519739', 'cui_str': 'anifrolumab'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0254653', 'cui_str': 'Interferon alpha-beta Receptor'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",20.0,0.0673545,SAEs occurred in 41% (Stage 1) and 33% (Stage 2) of patients; AEs leading to discontinuation occurred in 24% (Stage 1) and 22% (Stage 2) of patients.,"[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': ""Division of Allergy & Rheumatology, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Department of Rheumatology and Hematology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nakajima', 'Affiliation': 'Department of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Kawai', 'Affiliation': 'Department of Inflammation & Pain Control Research, Toho University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Nagashima', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Research and Development, AstraZeneca K.K., Osaka, Japan.'}, {'ForeName': 'Liangwei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Global Medicine Division, AstraZeneca Pharmaceuticals, Gaithersburg, MD, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Tummala', 'Affiliation': 'Global Medicine Division, AstraZeneca Pharmaceuticals, Gaithersburg, MD, USA.'}]",Modern rheumatology,['10.1080/14397595.2019.1583833']
3324,30802336,Reversal of the antiplatelet effect of ticagrelor by simulated platelet transfusion.,"BACKGROUND
Reversal of antiplatelet therapy is desirable in patients presenting with life-threatening bleeding or requiring urgent surgery. This study aimed to examine ticagrelor reversal using donor platelets and to explore the effects of residual ticagrelor on donor platelets.
STUDY DESIGN AND METHODS
In Cohort 1, 16 healthy subjects were treated with ticagrelor 90 mg twice daily alone or in combination with aspirin 100 mg once daily for 7 days followed by single blood sampling for preparation of platelet-rich plasma. An additional 16 healthy subjects served as controls. In Cohort 2, 16 healthy subjects were treated with ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 7 days followed by serial blood samplings for preparation of platelet-poor plasma (PPP). An additional 16 healthy subjects served as controls.
RESULTS
In Cohort 1, inhibition of adenosine diphosphate-induced platelet aggregation (PL ADP ) by ticagrelor could not be fully reversed by mixing with up to 90% control platelets, whereas inhibition of arachidonic acid-induced platelet aggregation by aspirin was fully reversed with the addition of 60% control platelets. In Cohort 2, 10% PPP obtained from ticagrelor-treated subjects reduced PL ADP from 74% to 40% at 2 hours, 72% to 58% at 6 hours, and 73% to 59% at 10 hours, while 10% or 20% PPP obtained from clopidogrel-treated subjects did not inhibit PL ADP .
CONCLUSION
The antiplatelet effect of ticagrelor cannot be fully reversed by donor platelets, which could be explained by the presence of active drug. The effect of residual drug on donor platelets appears to be evident for at least 10 hours after ticagrelor ingestion.",2019,"In Cohort 1, inhibition of adenosine diphosphate-induced platelet aggregation (PL ADP ) by ticagrelor could not be fully reversed by mixing with up to 90% control platelets, whereas inhibition of arachidonic acid-induced platelet aggregation by aspirin was fully reversed with the addition of 60% control platelets.","['16 healthy subjects served as controls', 'patients presenting with life-threatening bleeding or requiring urgent surgery', '16 healthy subjects']","['ticagrelor 90\u2009mg twice daily alone or in combination with aspirin', 'residual ticagrelor', 'ticagrelor 90\u2009mg twice daily or clopidogrel', 'ticagrelor']",['PL ADP'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}]",16.0,0.0657701,"In Cohort 1, inhibition of adenosine diphosphate-induced platelet aggregation (PL ADP ) by ticagrelor could not be fully reversed by mixing with up to 90% control platelets, whereas inhibition of arachidonic acid-induced platelet aggregation by aspirin was fully reversed with the addition of 60% control platelets.","[{'ForeName': 'Shuhua', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lianlian', 'Initials': 'L', 'LastName': 'Mei', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Fengwei', 'Initials': 'F', 'LastName': 'Zou', 'Affiliation': 'School of Medicine, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Kelecia', 'Initials': 'K', 'LastName': 'Niles', 'Affiliation': 'Emergency Department, West Demerara Regional Hospital, Vreed en Hoop, Guyana.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Chunjian', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}]",Transfusion,['10.1111/trf.15219']
3325,32484386,"Pamidronate in chronic non-bacterial osteomyelitis: a randomized, double-blinded, placebo-controlled pilot trial.","OBJECTIVE
This is the first randomized double-blinded, placebo-controlled pilot trial to investigate the efficacy of pamidronate in reducing radiological and clinical disease activity in chronic non-bacterial osteomyelitis (CNO).
METHOD
Patients received pamidronate or placebo at baseline and weeks 12 and 24. Whole-body magnetic resonance imaging was performed at baseline and weeks 12 and 36, and computed tomography of the anterior chest wall (ACW) at baseline and week 36. Radiological disease activity was systematically scored in the ACW and spine. Patient-reported outcomes [visual analogue scale (VAS) pain, VAS global health, Health Assessment Questionnaire (HAQ), EuroQol-5 Dimensions (EQ-5D), and 36-item Short-Form Health Survey (SF-36)] and biomarkers of bone turnover and inflammation were assessed at baseline and weeks 1, 4, 12, 24, and 36. Data are expressed as median [interquartile range].
RESULTS
Fourteen patients were randomized and 12 were analysed. From baseline to week 36, the radiological disease activity score in the ACW decreased from 5 [4-7] to 2.5 [1-3] in the pamidronate group, but did not change in the placebo group (p = 0.04). From baseline to week 36, VAS pain and VAS global health tended to decrease more in the pamidronate than in the placebo group (p = 0.11, p = 0.08). Physical functioning (HAQ) and health-related quality of life (EQ-5D, SF-36) did not change. Biomarkers of bone turnover decreased only in the pamidronate group (p ≤ 0.02).
CONCLUSION
Pamidronate may improve radiological and clinical disease activity in CNO. Methods to score radiological disease activity in adult CNO were suggested. Clinical Trials: NCT02594878.",2020,"Physical functioning (HAQ) and health-related quality of life (EQ-5D, SF-36) did not change.","['chronic non-bacterial osteomyelitis (CNO', 'Fourteen patients were randomized and 12 were analysed', 'chronic non-bacterial osteomyelitis']","['placebo', 'pamidronate or placebo', 'pamidronate', 'Pamidronate']","['radiological disease activity score', 'VAS pain and VAS global health', 'Radiological disease activity', 'Biomarkers of bone turnover', 'outcomes [visual analogue scale (VAS) pain, VAS global health, Health Assessment Questionnaire (HAQ), EuroQol-5 Dimensions (EQ-5D), and 36-item Short-Form Health Survey (SF-36)]\xa0and biomarkers of bone turnover and inflammation', 'Physical functioning (HAQ) and health-related quality of life (EQ-5D, SF-36']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0410422', 'cui_str': 'Chronic multifocal osteomyelitis'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043603', 'cui_str': 'pamidronate'}]","[{'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",14.0,0.488638,"Physical functioning (HAQ) and health-related quality of life (EQ-5D, SF-36) did not change.","[{'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Andreasen', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital , Aarhus, Denmark.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Jurik', 'Affiliation': 'Department of Radiology, Aarhus University Hospital , Aarhus, Denmark.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Deleuran', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital , Aarhus, Denmark.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Horn', 'Affiliation': 'Department of Rheumatology, Odense University Hospital , Odense, Denmark.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Folkmar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aarhus University Hospital , Aarhus, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Herlin', 'Affiliation': 'Department of Clinical Medicine, Aarhus University , Aarhus, Denmark.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Hauge', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital , Aarhus, Denmark.'}]",Scandinavian journal of rheumatology,['10.1080/03009742.2020.1724324']
3326,32484432,Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT.,"BACKGROUND
Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person's home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries.
OBJECTIVES
To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.
DESIGN
We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods.
SETTING
Home-based care without 24/7 paid care provision, in three UK sites.
PARTICIPANTS
Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency.
INTERVENTION
Intervention-group carers received training by local nurses using a manualised training package.
MAIN OUTCOME MEASURES
Quantitative data were collected at baseline and 6-8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures.
RESULTS
In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting > 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of > 40% retention was, therefore, considered not met. A total of 12 carers (intervention, n = 10; usual care, n = 2) and 20 health-care professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The context of the feasibility study was not ideal, as district nurses were seriously overstretched and unfamiliar with research methods. A disparity in readiness to consider the intervention was demonstrated between carers and health-care professionals. Findings showed that there were methodological and ethics issues pertaining to researching last days of life care.
CONCLUSION
The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN11211024.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 25. See the NIHR Journals Library website for further project information.",2020,"To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.
","['Home-based care without 24/7 paid care provision, in three UK sites', 'In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting >\u200930% of eligible dyads', '12 carers (intervention, n \u2009=\u200910; usual care, n \u2009=\u20092) and 20 health-care professionals were interviewed', 'people dying at home', 'Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication']","['Carer administration of as-needed subcutaneous medication', 'Intervention-group carers received training by local nurses using a manualised training package', 'intervention versus usual care, with a 1\u2009:\u20091 allocation ratio, using convergent mixed methods']","['overall retention rate', 'feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729338', 'cui_str': 'Care provision regime'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",101.0,0.0884507,"To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.
","[{'ForeName': 'Marlise', 'Initials': 'M', 'LastName': 'Poolman', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Wright', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hendry', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Nia', 'Initials': 'N', 'LastName': 'Goulden', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Emily Af', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': 'Marie Curie Research Centre, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perkins', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Annmarie', 'Initials': 'A', 'LastName': 'Nelson', 'Affiliation': 'Marie Curie Research Centre, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hiscock', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Dyfrig', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': ""O'Connor"", 'Affiliation': 'Sue Ryder Leckhampton Court Hospice, Cheltenham, UK.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Foster', 'Affiliation': 'Public Contributor, North Wales Cancer Patient Forum, North Wales Cancer Treatment Centre, Bodelwyddan, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Reymond', 'Affiliation': 'Brisbane South Palliative Care Collaborative, School of Medicine, Griffith University, Southport, QLD, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Healy', 'Affiliation': 'Metro South Palliative Care Service, Brisbane, QLD, Australia.'}, {'ForeName': 'Penney', 'Initials': 'P', 'LastName': 'Lewis', 'Affiliation': ""Centre for Medical Law and Ethics, King's College London, London, UK.""}, {'ForeName': 'Bee', 'Initials': 'B', 'LastName': 'Wee', 'Affiliation': 'Harris Manchester College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rosalynde', 'Initials': 'R', 'LastName': 'Johnstone', 'Affiliation': 'Betsi Cadwaladr University Health Board, Bangor, UK.'}, {'ForeName': 'Rossela', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Parkinson', 'Affiliation': 'Sue Ryder Leckhampton Court Hospice, Cheltenham, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': 'Betsi Cadwaladr University Health Board, Bangor, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Wilkinson', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24250']
3327,32484441,Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial.,"BACKGROUND
Social network sites (SNSs) are widely exploited in health education and communication by the general public, including patients with various conditions. Nevertheless, there is an absence of evidence evaluating SNSs in connecting health professionals for professional purposes.
OBJECTIVE
This pilot randomized controlled trial was designed to evaluate the feasibility of an intervention aiming to investigate the effects of a continuous professional education program utilizing Facebook to obtain knowledge on dementia and care for patients with dementia.
METHODS
Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40). The intervention was an 8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group) from October 2018 to January 2019. The primary outcomes were the effects of the intervention, measured by differences in the means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions. Other outcome measurements included participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs.
RESULTS
Significantly more intervention group participants (n=35) completed the study than the control group (n=25) (P<.001). The overall retention rate was 75% (60/80). The mean of changes in scores in the intervention group were significant in all assessments (P<.001). A significant difference in the mean of changes in scores between the two groups was identified in the DKAS subscale Communication and Behavior (95% CI 0.4-3.3, P=.02). There was no significant difference in the total DKAS scores, scores of other DKAS subscales, and multiple choice questions. Participant compliance was significantly higher in the intervention group than in the control group (P<.001). The mean numbers of participants accessing the learning materials were 31.5 (SD 3.9) and 17.6 (SD 5.2) in the intervention and control group, respectively. Polls attracted the highest level of participant engagement, followed by videos. Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03). Overall, participants were satisfied with the interventions (mean score 4 of a total of 5, SD 0.6).
CONCLUSIONS
The significantly higher retention rate, together with the high levels of participant compliance and engagement, demonstrate that Facebook is a promising tool for professional education. Education delivered through Facebook was significantly more effective at improving participants' knowledge of how people with dementia communicate and behave. Participants demonstrated positive attitudes toward utilizing Facebook for professional learning. These findings provide evidence for the feasibility of using Facebook as an intervention delivery tool in a manner that can be rolled out into practical settings.",2020,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"['Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40', 'patients with dementia', 'Continuous Professional Education on Dementia', 'patients with various conditions']","['8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group', 'continuous professional education program utilizing Facebook', 'Facebook']","['total DKAS scores, scores of other DKAS subscales, and multiple choice questions', 'mean numbers of participants accessing the learning materials', 'mean of changes in scores', 'means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions', 'participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs', 'DKAS subscale Communication and Behavior', 'overall retention rate', 'Participant compliance']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.081195,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"[{'ForeName': 'Windy Sy', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'School of Health Sciences, Caritas Institute of Higher Education, New Territories, China (Hong Kong).'}, {'ForeName': 'Angela Ym', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, China (Hong Kong).'}]",Journal of medical Internet research,['10.2196/16772']
3328,32484534,"Effect of C-Reactive Protein-Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients With Uncomplicated Gram-Negative Bacteremia: A Randomized Clinical Trial.","Importance
Antibiotic overuse drives antibiotic resistance. Gram-negative bacteremia is a common infection that results in substantial antibiotic use.
Objective
To compare the clinical effectiveness of C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations 30, 60, and 90 days after treatment initiation.
Design, Setting, and Participants
Multicenter, noninferiority, point-of-care randomized clinical trial including adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019. Patients and physicians were blinded between randomization and antibiotic discontinuation. Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression.
Intervention
Randomization in a 1:1:1 ratio to an individualized CRP-guided antibiotic treatment duration (discontinuation once CRP declined by 75% from peak; n = 170), fixed 7-day treatment duration (n = 169), or fixed 14-day treatment duration (n = 165).
Main Outcomes and Measures
The primary outcome was the clinical failure rate at day 30, defined as the presence of at least 1 of the following, with a non-inferiority margin of 10%: recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause. Secondary outcomes included the clinical failure rate on day 90 of follow-up.
Results
Among 504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up. Median antibiotic duration in the CRP group was 7 (interquartile range, 6-10; range, 5-28) days; 34 of the 164 patients (21%) who completed the 30-day follow-up had protocol violations related to treatment assignment. The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001). By day 90, clinical failure occurred in 10 of 143 patients (7.0%) in the CRP group, 16 of 151 (10.6%) in the 7-day group, and 16 of 153 (10.5%) in the 14-day group.
Conclusions and Relevance
Among adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment were noninferior to fixed 14-day treatment. However, interpretation is limited by the large noninferiority margin compared with the low observed event rate, as well as low adherence and wide range of treatment durations in the CRP-guided group.
Trial Registration
ClinicalTrials.gov Identifier: NCT03101072.",2020,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","['Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression', 'With Uncomplicated Gram-Negative Bacteremia', 'Patients', 'adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019', 'adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment', '504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up']","['individualized CRP-guided antibiotic treatment duration (discontinuation once CRP', 'C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations', 'C-Reactive Protein-Guided Antibiotic']","['clinical failure rate', 'Median antibiotic duration', 'clinical failure rate on day 90 of follow-up', '30-Day Clinical Failure Rate', 'recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause', 'clinical failure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018150', 'cui_str': 'Gram-negative bacterium'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C3160894', 'cui_str': 'Complicated infection'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0744471', 'cui_str': 'Gram-negative bacteremia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C3203360', 'cui_str': 'Suppuration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",504.0,0.162586,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'von Dach', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Werner C', 'Initials': 'WC', 'LastName': 'Albrich', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Brunel', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Prendki', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Cuvelier', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Flury', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Gayet-Ageron', 'Affiliation': 'Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kohler', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lemmenmeier', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'McCallin', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rossel', 'Affiliation': 'Department of Internal Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Kaiser', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Bochud', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}]",JAMA,['10.1001/jama.2020.6348']
3329,32484552,Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial.,"Importance
Many shift workers have difficulty sleeping during the daytime owing to an inappropriately timed circadian drive for wakefulness.
Objective
To determine whether a dual hypocretin receptor antagonist would enable shift workers to have more daytime sleep.
Design, Setting, and Participants
This double-blind, placebo-controlled randomized clinical trial included 2 weeks of baseline data and 3 weeks of intervention data, from March 2016 to December 2018. Individuals were recruited through poster advertisements in the broader San Francisco Bay area in California. From an initial voluntary recruitment cohort of 38 shift workers, 19 individuals with self-reported difficulty sleeping during the daytime following night work shift were included. Data were analyzed from Janaury to March 2019.
Interventions
1 week of 10 mg suvorexant or placebo, titrated upward to 20 mg suvorexant or placebo for 2 additional weeks.
Main Outcomes and Measures
Objective (ie, actigraphy) and subjective (ie, sleep logs) measures of sleep.
Results
Among 19 participants who completed the study (mean [SD] age, 37.7 [11.1] years; 13 [68%] men), 8 participants (42%) were assigned to the suvorexant group and 11 participants (58%) were assigned to the placebo group. Compared with individuals in the placebo group, individuals in the suvorexant group increased their objective total sleep time by a mean (SE) of 1.04 (0.53) hours (P = .05) at the end of 1 week of 10-mg doses and by 2.16 (0.75) hours (P = .004) by the end of the 2 weeks of 20-mg doses. Subjective sleep was similarly improved as, compared with the placebo group, individuals in the suvorexant group increased their subjective total sleep time by a mean (SE) of 2.08 (0.47) hours (P < .001) at the end of 1 week of 10-mg doses and by 2.97 (0.56) hours (P < .001) by the end of the 2 weeks of 20-mg doses. Physician ratings of daytime sleep aligned with these measures, as there was no change in the placebo group and a much improved change in the suvorexant group. No adverse events were reported in the suvorexant group.
Conclusions and Relevance
This pilot study found that the use of a dual hypocretin receptor antagonist in shift workers under real-world conditions resulted in more than 2 extra hours of daytime sleep per episode. Future research should confirm this pilot finding in a larger sample size and examine whether, over the long term, use of this medication has a concomitant improvement in medical and psychiatric health as well as workplace performance and safety.
Trial Registration
ClinicalTrials.gov Identifier: NCT02491788.",2020,"No adverse events were reported in the suvorexant group.
","['19 participants who completed the study (mean [SD] age, 37.7 [11.1] years; 13 [68%] men), 8 participants (42%) were assigned to the suvorexant group and 11 participants (58', 'Shift Workers', '38 shift workers, 19 individuals with self-reported difficulty sleeping during the daytime following night work shift were included', 'Individuals were recruited through poster advertisements in the broader San Francisco Bay area in California']","['placebo', 'suvorexant or placebo, titrated upward to 20 mg suvorexant or placebo', 'Suvorexant vs Placebo', 'dual hypocretin receptor antagonist']","['Subjective sleep', 'objective total sleep time', 'ie, sleep logs) measures of sleep', 'Total Daytime Sleep Hours', 'subjective total sleep time', 'adverse events', 'Physician ratings of daytime sleep', 'Measures\n\n\nObjective (ie, actigraphy) and subjective ']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",,0.328829,"No adverse events were reported in the suvorexant group.
","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zeitzer', 'Affiliation': 'Stanford Center for Sleep Sciences And Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Joyce', 'Affiliation': 'Stanford Center for Sleep Sciences And Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'McBean', 'Affiliation': 'Stanford Center for Sleep Sciences And Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Yvonne L', 'Initials': 'YL', 'LastName': 'Quevedo', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center, VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Hernandez', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center, VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Jon-Erik', 'Initials': 'JE', 'LastName': 'Holty', 'Affiliation': 'Pulmonary, Critical Care, and Sleep Medicine Section, VA Palo Alto Health Care System, Palo Alto, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6614']
3330,32484623,Effects of Colloidal Oatmeal Topical Atopic Dermatitis Cream on Skin Microbiome and Skin Barrier Properties.,"Atopic dermatitis is characterized by dry, itchy, inflamed skin with a dysbiotic microbiome. In this clinical study (NCT03673059), we compared the effects of an eczema cream containing 1% colloidal oat and a standard moisturizer on the skin microbiome and skin barrier function of patients with mild to moderate eczema. Patients were randomly assigned to treatment with 1% colloidal oat eczema cream or a standard, non-fragranced daily moisturizer. Treatment lasted 14 days, followed by a 7-day regression period. Of 61 patients who completed the study, 30 received the 1% colloidal oat eczema cream and 31 received the standard moisturizer. At 14 days, the 1% colloidal oat eczema cream reduced mean Eczema Area Severity Index and Atopic Dermatitis Severity Index scores by 51% and 54%, respectively. Unlike treatment with the standard moisturizer, treatment with the 1% colloidal oat eczema cream was associated with trends towards lower prevalence of Staphylococcus species and higher microbiome diversity at lesion sites. The 1% colloidal oat eczema cream significantly improved skin pH, skin barrier function, and skin hydration from baseline to day 14, whereas the standard moisturizer improved hydration. Overall, the results demonstrate that topical products can have differing effects on the skin barrier properties and the microbiome. Importantly, we show that the use of a 1% colloidal oat eczema cream improves microbiome composition and significantly repairs skin barrier defects. J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.4924.",2020,"At 14 days, the 1% colloidal oat eczema cream reduced mean Eczema Area Severity Index and Atopic Dermatitis Severity Index scores by 51% and 54%, respectively.","['patients with mild to moderate eczema', '61 patients who completed the study, 30 received the 1']","['colloidal oat eczema cream', 'eczema cream containing 1% colloidal oat and a standard moisturizer', 'colloidal oat eczema cream or a standard, non-fragranced daily moisturizer', 'Colloidal Oatmeal Topical Atopic Dermatitis Cream']","['Skin Microbiome and Skin Barrier Properties', 'skin pH, skin barrier function, and skin hydration', 'microbiome composition and significantly repairs skin barrier defects', 'mean Eczema Area Severity Index and Atopic Dermatitis Severity Index scores', 'Atopic dermatitis', 'skin microbiome and skin barrier function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3209951', 'cui_str': 'Colloidal oatmeal Topical Product'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0232445', 'cui_str': 'Acid mantle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0580646', 'cui_str': 'Integumentary system repair'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0257009,"At 14 days, the 1% colloidal oat eczema cream reduced mean Eczema Area Severity Index and Atopic Dermatitis Severity Index scores by 51% and 54%, respectively.","[{'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Capone', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kirchner', 'Affiliation': ''}, {'ForeName': 'Shifra Liba', 'Initials': 'SL', 'LastName': 'Klein', 'Affiliation': ''}, {'ForeName': 'Neena K', 'Initials': 'NK', 'LastName': 'Tierney', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,[]
3331,32484629,Halobetasol 0.01%/Tazarotene 0.045% Lotion for Moderate-to-Severe Psoriasis: Pooled Phase 3 Analysis of Males and Females.,"BACKGROUND
Previous results from two phase 3 studies demonstrated efficacy and safety of fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in participants with moderate-to-severe plaque psoriasis. This post hoc analysis evaluated sex-specific efficacy and safety of HP/TAZ lotion.
METHODS
In two randomized, double-blind, phase 3 studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Male and female participants were evaluated separately in this pooled analysis. Efficacy assessments included treatment success (at least 2‑grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), impact on individual signs of psoriasis, and affected Body Surface Area (BSA).
RESULTS
The analysis included 272 males (HP/TAZ, n=175; vehicle, n=97) and 146 females (HP/TAZ, n=101; vehicle, n=45). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle in both male (38.4% vs 9.8%) and female (44.5% vs 9.9%) subgroups (P<0.001, both). Erythema, plaque elevation, and scaling were also reduced by week 8 in both males and females, with significantly more HP/TAZ-treated participants achieving at least 2‑grade improvement in each sign of psoriasis than vehicle-treated participants (P<0.001 each, both groups). Mean reductions in affected BSA were significantly greater with HP/TAZ versus vehicle lotion in both males and females (P≤0.001, both). The most frequent treatment-related adverse events were contact dermatitis, pruritis, and application site pain (each 4.0%) in females and contact dermatitis (7.6%) in males.
CONCLUSION
HP/TAZ lotion was highly effective and safe in both males and females with moderate-to-severe psoriasis over 8 weeks of once-daily use. J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.5021.",2020,"Mean reductions in affected BSA were significantly greater with HP/TAZ versus vehicle lotion in both males and females (P≤0.001, both).","['participants with moderate-to-severe plaque psoriasis', 'Moderate-to-Severe Psoriasis', '272 males (HP/TAZ, n=175; vehicle, n=97) and 146 females (HP/TAZ, n=101; vehicle, n=45', 'Male and female participants']","['HP/TAZ', 'vehicle lotion', 'HP/TAZ lotion', 'Halobetasol 0.01%/Tazarotene 0.045% Lotion', 'fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion', 'HP/TAZ or vehicle lotion']","['overall treatment success', 'contact dermatitis, pruritis, and application site pain', 'Erythema, plaque elevation, and scaling', ""Investigator's Global Assessment [IGA] score and score of clear/almost clear), impact on individual signs of psoriasis, and affected Body Surface Area (BSA"", 'Mean reductions in affected BSA']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0098735', 'cui_str': 'Halobetasol propionate'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0098735', 'cui_str': 'Halobetasol propionate'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0082787', 'cui_str': 'halobetasol'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011616', 'cui_str': 'Contact dermatitis'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0521491', 'cui_str': 'Application site pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",272.0,0.315218,"Mean reductions in affected BSA were significantly greater with HP/TAZ versus vehicle lotion in both males and females (P≤0.001, both).","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': ''}, {'ForeName': 'Boni', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': ''}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Draelos', 'Affiliation': ''}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': ''}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,[]
3332,32479320,Antidepressive effect of left dorsolateral prefrontal cortex neurofeedback in patients with major depressive disorder: A preliminary report.,"Background Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) have recently attracted attention as a novel, individualized treatment method for major depressive disorder (MDD). In this study, the antidepressant effect of neurofeedback training for left dorsolateral prefrontal cortex (DLPFC) activity was examined. Methods Six patients with MDD completed 5 days of neurofeedback training sessions. In each session, the patients observed a BOLD signal within their left DLPFC as a line graph, and attempted to up-regulate the signal using the graphical cue. Primary outcome measures were clinical scales of severity of depression and rumination. Results After neurofeedback training, the clinical measures were improved significantly. In addition, patient proficiency for neurofeedback training was related significantly to the improvement of the rumination symptom. Limitations Study limitations include the lack of a control group or condition, the lack of transfer run, and the small number of participants. Conclusions This small sample study suggests the possible efficacy of DLPFC activity regulation training for the treatment of MDD. As a next step, a sham-controlled randomized clinical trial is needed to confirm the antidepressive effect of left DLPFC neurofeedback.",2020,"In addition, patient proficiency for neurofeedback training was related significantly to the improvement of the rumination symptom.","['Methods Six patients with MDD completed 5\xa0days of neurofeedback training sessions', 'patients with major depressive disorder']","['DLPFC activity regulation training', 'neurofeedback training', ' Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf']","['rumination symptom', 'BOLD signal', 'clinical scales of severity of depression and rumination', 'left dorsolateral prefrontal cortex (DLPFC) activity']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",6.0,0.0291146,"In addition, patient proficiency for neurofeedback training was related significantly to the improvement of the rumination symptom.","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takamura', 'Affiliation': 'Brain, Mind and KANSEI Sciences Research Center, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Chiyo', 'Initials': 'C', 'LastName': 'Shibasaki', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Yoshino', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Okada', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Brain, Mind and KANSEI Sciences Research Center, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Yamawaki', 'Affiliation': 'Brain, Mind and KANSEI Sciences Research Center, Hiroshima University, Hiroshima, Japan; Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. Electronic address: yamawaki@hiroshima-u.ac.jp.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.080']
3333,32479321,"Appraising esketamine nasal spray for the management of treatment-resistant depression in adults: Number needed to treat, number needed to harm, and likelihood to be helped or harmed.","INTRODUCTION
This post hoc study assessed the evidence-base for esketamine nasal spray for management of treatment-resistant depression (TRD) using number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH).
METHODS
Data sources were four phase III randomized, double-blind studies including two positive studies (acute flexible-dose; maintenance) in patients with TRD. Key efficacy study outcomes: acute response (≥50% decrease from baseline on Montgomery-Asberg Depression Rating Scale [MADRS] total score), acute remission (MADRS scores ≤12). NNT, NNH were calculated for esketamine nasal spray+newly initiated oral antidepressant (esketamine+AD) vs. placebo+AD.
RESULTS
In the pivotal acute flexible-dose study, MADRS response (63.4% vs. 49.5%) and remission (48.2% vs. 30.3%) at 4 weeks resulted in NNT of 8 and 6 for esketamine+AD vs. placebo+AD. NNH values <10 included dissociation (26.1% vs. 3.7%), vertigo (26.1% vs. 2.8%), nausea (26.1% vs. 6.4%), dizziness (20.9% vs. 4.6%), and dysgeusia (24.3% vs. 11.9%). Discontinuation rates due to adverse events (AE) (7.0% vs. 0.9%) yielded NNH=17. LHH comparing MADRS remission vs. discontinuation due to AE was 17 vs. 6. Maintenance use of esketamine+AD demonstrated NNT values<10 for relapse and/or maintenance of remission. In maintenance study, discontinuation due to AE (2.6% vs. 2.1%) yielded NNH=178 (non-significant).
LIMITATIONS
Only dichotomous outcomes were included.
CONCLUSION
NNT<10 for efficacy outcomes suggests potential benefit of esketamine+AD for both acute and maintenance use. LHH was favorable: esketamine+AD was 3 times likely to result in acute remission vs. discontinuations due to AE.",2020,Discontinuation rates due to adverse events (AE) (7.0% vs. 0.9%) yielded NNH=17.,"['adults', 'Data sources were four phase III randomized, double-blind studies including two positive studies (acute flexible-dose; maintenance) in patients with TRD']",['AE'],"['dizziness', 'Montgomery-Asberg Depression Rating Scale [MADRS] total score), acute remission (MADRS scores ≤12', 'vertigo', 'dysgeusia', 'MADRS response', 'acute response', 'nausea', 'remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011001', 'cui_str': 'Data Sources'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.323776,Discontinuation rates due to adverse events (AE) (7.0% vs. 0.9%) yielded NNH=17.,"[{'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Citrome', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, Valhalla, NY 10595, United States. Electronic address: citrome@cnsconsultant.com.'}, {'ForeName': 'Allitia', 'Initials': 'A', 'LastName': 'DiBernardo', 'Affiliation': 'Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, United States.'}, {'ForeName': 'Jaskaran', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, CA 92121, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.106']
3334,32479328,Lessons learned from a pilot randomized controlled trial of dyadic interpersonal psychotherapy for perinatal depression in a low-income population.,"BACKGROUND
Perinatal depression is a public health burden impacting mothers and their offspring. This study extended brief-Interpersonal Psychotherapy delivered during pregnancy by incorporating a postpartum attachment based dyadic-component to maintain mother's treatment gains and enhance the mother-infant relationship (called IPT-Dyad). The current report presents data from a pilot randomized controlled trial comparing IPT-Dyad to Enhanced Treatment as Usual (ETAU).
METHODS
Women, ages 18 and older, between 12-30 weeks gestation meeting criteria for a depressive disorder were eligible. Participants were randomized to either IPT-Dyad (n = 21) or ETAU (n = 21). Maternal and infant outcomes were assessed through one-year postpartum.
RESULTS
Participants were primarily African American (77%), single (80%), with low-incomes. Attrition was high in both groups (IPT-Dyad 30%; ETAU 40%). Depression scores improved from baseline in both groups and remained improved over the 12 month follow-up. There were no between group differences on measures of parenting stress, mother-infant interactions, and infant socioemotional functioning.
LIMITATIONS
The small sample size of this study was further reduced by attrition, despite efforts to maintain engagement. Reliance on self-report outcome measures is also a limitation.
CONCLUSIONS
IPT-Dyad may be a promising intervention for perinatal depression with potential benefit for mothers and babies. Treatment engagement and management of psychosocial needs were persistent challenges throughout the postpartum period. Further refinement of intervention content and schedule to better meet the needs and values of under-resourced mothers is needed. Earlier screening; better integration of care within OB settings; and delivering care in conjunction with social service resources may also improve outcomes.",2020,"There were no between group differences on measures of parenting stress, mother-infant interactions, and infant socioemotional functioning.
","['perinatal depression in a low-income population', 'Participants were primarily African American (77%), single (80%), with low-incomes', 'Women, ages 18 and older, between 12-30 weeks gestation meeting criteria for a depressive disorder were eligible']","['IPT-Dyad (n\xa0=\xa021) or ETAU', 'Interpersonal Psychotherapy', 'dyadic interpersonal psychotherapy']","['Depression scores', 'parenting stress, mother-infant interactions, and infant socioemotional functioning', 'Attrition']","[{'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3658199', 'cui_str': 'Mother-Infant Relations'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",,0.157194,"There were no between group differences on measures of parenting stress, mother-infant interactions, and infant socioemotional functioning.
","[{'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA. Electronic address: slenze@wustl.edu.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Potts', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rodgers', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.084']
3335,32479544,Long-term effects of a three-component lifestyle intervention on emotional well-being in women with Polycystic Ovary Syndrome (PCOS): A secondary analysis of a randomized controlled trial.,"Many women with Polycystic Ovary Syndrome (PCOS) report high depression rates. The relationship between PCOS and these high depression rates is unclear. Two-component lifestyle interventions have revealed short-term effects on depression scores in this group of women. In general, 3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT) are more effective in the long-term to improve emotional well-being. This has not yet been studied in women with PCOS. This study examined the effect of 20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight). In this secondary analysis, 155 women with PCOS and a BMI above 25 kg/m2 were eligible. Depression scores decreased significantly in the LS programme compared to CAU (P = 0.045). In both the LS programme without SMS (P = 0.036) and the LS programme with SMS (P = 0.011) depression scores decreased while no change was observed in CAU (P = 0.875). Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027). No differences in body image scores were observed in LS participants compared to CAU (P = 0.087), although body image improved significantly in both the LS without SMS (P = 0.001) and with SMS (P = 0.008) study arms. We found no significant mediating role by androgens in the relationship between LS participants and emotional well-being. Only weight-loss mediated the relationship between LS and self-esteem. To conclude, a three-component lifestyle intervention programme with or without additional SMS resulted in significant improvements in depression and self-esteem compared to CAU, in women with PCOS, obesity, and a wish to achieve a pregnancy. Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol did not mediate this effect. Weight loss mediated the effects on self-esteem but not on depression and body-image. This suggests that lifestyle treatment independent of weight loss can reduce depression and body-image, but both lifestyle treatment and weight loss can improve self-esteem. Thus, a three-component lifestyle intervention based on CBT could prove successful in improving mood in women with PCOS who are overweight or obese and attempting to become pregnant.",2020,Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027).,"['155 women with PCOS and a BMI above 25 kg/m2 were eligible', 'women with Polycystic Ovary Syndrome (PCOS', 'women with PCOS', 'women with PCOS who are overweight or obese and attempting to become pregnant']","['three-component lifestyle intervention', 'CBT', '3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT', '20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight']","['Depression scores', 'depression and self-esteem', 'Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol', 'depression scores', 'body image scores', 'self-esteem', 'Self-esteem scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",155.0,0.0638994,Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027).,"[{'ForeName': 'Geranne', 'Initials': 'G', 'LastName': 'Jiskoot', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dietz de Loos', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Annemerle', 'Initials': 'A', 'LastName': 'Beerthuizen', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busschbach', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'Laven', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0233876']
3336,32480252,The Efficacy of Lidocaine in Disrupting Cocaine Cue-Induced Memory Reconsolidation.,"RATIONAL
Cue-induced craving memories, linked to drug-seeking behaviors, require key molecular processes for memory reconsolidation. Lidocaine, a sodium channel blocker, inhibits NMDA receptor activation and suppresses nitric oxide and ERK production. These processes are required for memory re-consolidation; inhibiting them may reduce cue-related craving memories in cocaine dependent subjects.
OBJECTIVES
To assess the efficacy of lidocaine in decreasing cue-induced cocaine craving and cocaine use.
METHODS
Treatment-seeking cocaine-dependent participants (n = 33, 25 men) were recruited. Personalized craving and relaxation scripts were developed. Participants were then randomly assigned in a double-blind design to either receive intravenous lidocaine immediately following a cocaine craving script (lidocaine/craving), saline following a craving script (saline/craving), or lidocaine following a relaxation script (lidocaine/relax). One week following the infusion, cue-induced craving was assessed in the same paradigm without an infusion. Cocaine use and craving were assessed for 4 weeks following infusion.
RESULTS
The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group. There were no significant differences in craving and cocaine use between the lidocaine/relax and saline/craving groups.
CONCLUSION
Lidocaine administered following craving induction did not decrease subsequent cue-induced craving or cocaine use. Blocking the reconsolidation of craving-related memories with pharmacological agents remains an important area of investigation.",2020,The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group.,"['Treatment-seeking cocaine-dependent participants (n = 33, 25 men']","['Lidocaine', 'lidocaine/craving', 'lidocaine', 'intravenous lidocaine', 'cocaine craving script (lidocaine/craving), saline following a craving script (saline/craving), or lidocaine following a relaxation script (lidocaine/relax', 'Cocaine']",['craving and cocaine'],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",,0.054462,The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group.,"[{'ForeName': 'Josh E', 'Initials': 'JE', 'LastName': 'Becker', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'Julianne L', 'Initials': 'JL', 'LastName': 'Price', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leonard', 'Affiliation': 'David Leonard Statistical Consulting, Wichita Falls, TX USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Suris', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; VA North Texas Health Care System, Dallas, TX USA.'}, {'ForeName': 'Enas', 'Initials': 'E', 'LastName': 'Kandil', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO USA; Department of Anesthesiology & Pain Management, UT Southwestern Medical Center, Dallas, TX USA; School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; VA North Texas Health Care System, Dallas, TX USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Kroener', 'Affiliation': 'School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108062']
3337,32480307,Prolonged-release melatonin in Parkinson's disease patients with a poor sleep quality: A randomized trial.,"BACKGROUND
The present study was a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of prolonged-release melatonin (PRM) in Parkinson's disease (PD) patients with poor sleep quality.
METHODS
PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score > 5 were included. Patients were assessed using the PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale (UPDRS)-III at the beginning of the study and after 4 weeks of treatment with 2 mg of PRM. Partial correlation analysis was performed to investigate the relationship between PSQI score and the other scales.
RESULTS
Thirty-four PD patients with poor sleep quality were enrolled and divided into 2 groups based on medication; PRM (n = 16) and placebo (n = 18). Regarding efficacy, PSQI was significantly improved in the PRM group compared to the control group. Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group. PSQI improvement correlated with improvement in NMSS score and PDQ-39 summary index. Regarding safety, all enrolled subjects did not complain of side effects due to PRM.
CONCLUSION
PRM is an effective and safe treatment option for subjective sleep quality in PD patients and beneficial effects on sleep quality are associated with improved non-motor symptoms and quality of life in PD patients.",2020,Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group.,"['PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score', 'Thirty-four PD patients with poor sleep quality', ""Parkinson's disease (PD) patients with poor sleep quality"", '\xa05 were included', ""Parkinson's disease patients with a poor sleep quality""]","['Prolonged-release melatonin', 'prolonged-release melatonin (PRM', 'PRM', 'placebo']","['subjective sleep quality', ""PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale"", 'efficacy, PSQI', 'NMSS and PDQ-39 summary index', 'efficacy and safety', 'NMSS score and PDQ-39 summary index', 'UPDRS-III score']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.0488383,Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group.,"[{'ForeName': 'Jong Hyeon', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Minkyeong', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Suyeon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Biostatistics, Soonchunhyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Wooyoung', 'Initials': 'W', 'LastName': 'Jang', 'Affiliation': 'Department of Neurology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Jinse', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Haeundae Paik Hospital, Inje University, Busan, Republic of Korea.'}, {'ForeName': 'Eungseok', 'Initials': 'E', 'LastName': 'Oh', 'Affiliation': 'Department of Neurology, Chungnam National University Hospital, College of Medicine, Daejun, Republic of Korea.'}, {'ForeName': 'Jin Whan', 'Initials': 'JW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea. Electronic address: sunnyfor@hanmail.net.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Youn', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Neuroscience Center, Samsung Medical Center, Seoul, Republic of Korea. Electronic address: genian@skku.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.03.029']
3338,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE
The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD
A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS
A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION
These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
3339,32480409,"Dose-Response Relationships Between Gonadal Steroids and Bone, Body Composition, and Sexual Function in Aging Men.","CONTEXT
Most labs set the lower limit of normal for testosterone at the 2.5th percentile of values in young or age-matched men, an approach that does not consider the physiologic changes associated with various testosterone concentrations.
OBJECTIVE
To characterize the dose-response relationships between gonadal steroid concentrations and measures regulated by gonadal steroids in older men.
DESIGN, PARTICIPANTS, AND INTERVENTION
177 men ages 60-80 were randomly assigned to receive goserelin acetate plus either 0 (placebo),1.25, 2.5, 5, or 10 grams of a 1% testosterone gel daily for 16 weeks, or placebos for both medications (controls).
PRIMARY OUTCOMES
Changes in serum C-telopeptide (CTX), total body fat by dual energy x-ray absorptiometry (DXA), and self-reported sexual desire.
RESULTS
Clear relationships between the testosterone dosage (or the resulting testosterone levels) and a variety of outcome measures were observed. Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0-99, 100-199, 200-299 ng/dL, or 300-499 ng/dL whereas increases in total body fat, subcutaneous fat, and thigh fat exceeded controls when testosterone levels were 0-99 or 100-199 ng/dL. Sexual desire and erectile function were indistinguishable from controls until testosterone levels were <100 ng/dL.
CONCLUSION
Changes in measures of bone resorption, body fat, and sexual function begin at a variety of testosterone concentrations with many outcome measures remaining stable until testosterone levels are well below the stated normal ranges. In light of this variation, novel approaches for establishing the normal range for testosterone are needed.",2020,Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0-99,"['Aging Men', '177 men ages 60-80', 'older men']","['testosterone gel daily for 16 weeks, or placebos', 'goserelin acetate plus either 0']","['Sexual desire and erectile function', 'serum CTX', 'total body fat, subcutaneous fat, and thigh fat exceeded controls when testosterone levels', 'bone resorption, body fat, and sexual function', 'serum C-telopeptide (CTX), total body fat by dual energy x-ray absorptiometry (DXA), and self-reported sexual desire', 'Bone, Body Composition, and Sexual Function']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700476', 'cui_str': 'Goserelin acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.0765777,Changes in serum CTX exceeded changes in the controls in men whose testosterone levels were 0-99,"[{'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Finkelstein', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Sherri-Ann M', 'Initials': 'SM', 'LastName': 'Burnett-Bowie', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Darakananda', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Gentile', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Goldstein', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Prizand', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Krivicich', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Taylor', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Kendra E', 'Initials': 'KE', 'LastName': 'Wulczyn', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}, {'ForeName': 'Elaine W', 'Initials': 'EW', 'LastName': 'Yu', 'Affiliation': 'Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston MA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa318']
3340,32480413,STEEER-AF: a cluster-randomized education trial from the ESC.,,2020,,[],[],[],[],[],[],,0.0707677,,"[{'ForeName': 'Karina V', 'Initials': 'KV', 'LastName': 'Bunting', 'Affiliation': 'Postdoctoral Fellow, University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, UK; STEEER-AF coordinator.'}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Van Gelder', 'Affiliation': 'Professor of Cardiology, University of Groningen, University Medical Center Groningen, Netherlands; EHRA & ESC Council on Stroke; STEEER-AF Co-Chief Investigator.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Kotecha', 'Affiliation': 'Professor of Cardiology, University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, UK; ESC Education & ESC Congress Planning Committees; ESC 2016 AF Guidelines Taskforce; STEEER-AF Chief Investigator.'}]",European heart journal,['10.1093/eurheartj/ehaa421']
3341,31163337,Evaluation of needle biopsy as a potential risk factor for local recurrence of Wilms tumour in the SIOP WT 2001 trial.,"RATIONALE
The impact of biopsying Wilms tumour (WT) at diagnosis on assigning the tumour stage and recommended treatment remains controversial. To address this important question, we analysed the potential association of all types of biopsy with local recurrence in patients treated in the SIOP WT 2001 trial, where needle biopsy was permitted without 'upstaging' the tumour to stage III. Only open biopsy required treatment as stage III.
METHODS
Among 2971 patients with unilateral WT (stages I-IV), 420 relapsed (139 local). Risk factors for recurrence were analysed by Cox proportional hazard methods.
RESULTS
Biopsy was performed in 969 of 2971 (33%) patients (64% cutting needle, 30% fine needle aspiration [FNA] and 6% open biopsy). Biopsied patients were older, with larger tumours and a greater proportion with high-risk histology. In multivariate analysis that included all factors associated with local recurrence in univariate analysis, only high-risk histology (hazard ratio [HR] = 2.32; 95% confidence interval [CI]: 1.58-3.42, p=<0.0001), age≥2 years (HR = 2.24; 95% CI: 1.22-4.09, p = 0.01) and preoperative tumour volume (HR = 1.07 per 100 ml; 95% CI: 1.02-1.12, p = 0.01) were significant. The HR for the association of local recurrence and event-free and overall survival with biopsy was not significant (HR = 1.4; 95% CI: 0.9-2.17, p = 0.13; HR = 1.1; 95% CI: 0.85-1.42, p = 0.46 and HR = 1.13; 95% CI: 0.79-1.62, p = 0.51, respectively). These results were not materially different whether FNA or open biopsy were included in the biopsy group or not.
CONCLUSIONS
This post hoc analysis provides some reassurance that needle biopsy is not an independent adverse factor for either local recurrence or survival after adjustment for all relevant risk factors. Needle biopsy should not be an automatic criterion to 'upstage' WT.",2019,"HR = 1.1; 95% CI: 0.85-1.42, p = 0.46 and HR = 1.13; 95% CI: 0.79-1.62, p = 0.51, respectively).","['2971 patients with unilateral WT (stages I-IV), 420 relapsed (139 local', 'Biopsied patients were older, with larger tumours and a greater proportion with high-risk histology']","['FNA', 'needle biopsy']","['local recurrence and event-free and overall survival with biopsy', 'preoperative tumour volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0027708', 'cui_str': 'Nephroblastoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0475278', 'cui_str': 'Large tumor'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019638', 'cui_str': 'Histology'}]","[{'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0005560', 'cui_str': 'Needle biopsy'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}]",2971.0,0.0698847,"HR = 1.1; 95% CI: 0.85-1.42, p = 0.46 and HR = 1.13; 95% CI: 0.79-1.62, p = 0.51, respectively).","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Irtan', 'Affiliation': 'Cancer Section, Developmental Biology & Cancer Programme, UCL Great Ormond Street Institute of Child Health, University College London, London, UK; Paediatric Surgery Department, Trousseau Hospital - Assistance Publique des Hôpitaux de Paris, Paris, France. Electronic address: Sabine.irtan@gmail.com.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'Van Tinteren', 'Affiliation': 'Biostatistics Department, Netherlands Cancer Institute - Antonie van Leeuwenhoekhuis Plesmanlaan, Amsterdam, Netherlands. Electronic address: h.v.tinteren@nki.nl.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Graf', 'Affiliation': 'Saarland University, Department of Pediatric Oncology & Hematology, Homburg, Germany. Electronic address: Norbert.Graf@uniklinikum-saarland.de.'}, {'ForeName': 'Marry M', 'Initials': 'MM', 'LastName': 'van den Heuvel-Eibrink', 'Affiliation': 'Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands. Electronic address: m.m.vandenheuvel-eibrink@prinsesmaximacentrum.nl.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Heij', 'Affiliation': 'Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands. Electronic address: hugo.heij@icloud.com.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bergeron', 'Affiliation': 'Pediatric Oncology Unit, Centre Léon Bérard, Lyon, France. Electronic address: christophe.bergeron@ihope.fr.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'de Camargo', 'Affiliation': 'Pediatric Hematology and Oncology Program, Research Center, Instituto Nacional de Câncer, Rio de Janeiro, Brazil. Electronic address: bdecamar@terra.com.br.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Acha', 'Affiliation': 'Department of Pediatric Oncology, Hospital Materno-Infantil, Malaga, Spain. Electronic address: tachavalls@gmail.com.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Spreafico', 'Affiliation': 'Department of Clinical Oncology and Hematology, Pediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy. Electronic address: filippo.spreafico@istitutotumouri.mi.it.'}, {'ForeName': 'Gordan', 'Initials': 'G', 'LastName': 'Vujanic', 'Affiliation': 'Department of Pathology, Sidra Medicine, Doha, Qatar. Electronic address: gvujanic@sidra.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Powis', 'Affiliation': 'Department of Paediatric Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK. Electronic address: Mark.Powis@nhs.uk.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Okoye', 'Affiliation': 'St. Georges Healthcare NHS Trust, Tooting, London, UK. Electronic address: bruce.okoye@nhs.net.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Wilde', 'Affiliation': 'Division of Pediatric Surgery, Geneva University Hospitals, University Center of Pediatric Surgery of Western Switzerland, Geneva, Switzerland. Electronic address: jim.wilde@hcuge.ch.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Godzinski', 'Affiliation': 'Department of Paediatric Surgery, Marciniak Hospital, and Dept. of Paediatric Traumatology and Emergency Medicine, Medical University, Wroclaw, Poland. Electronic address: jgodzin@wp.pl.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Pritchard-Jones', 'Affiliation': 'Cancer Section, Developmental Biology & Cancer Programme, UCL Great Ormond Street Institute of Child Health, University College London, London, UK. Electronic address: k.pritchard-jones@ucl.ac.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.027']
3342,30851300,Immunogenicity of Guselkumab Is Not Clinically Relevant in Patients with Moderate-to-Severe Plaque Psoriasis.,,2019,,['Patients with Moderate-to-Severe Plaque Psoriasis'],['Guselkumab'],['Immunogenicity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}]",[],,0.0385502,,"[{'ForeName': 'Yaowei', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA. Electronic address: yzhu8@its.jnj.com.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Marini', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Randazzo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Yaung-Kaung', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Honghui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.02.018']
3343,30877239,Implications of the local haemodynamic forces on the phenotype of coronary plaques.,"AIM
To examine the effect of endothelial shear stress (ESS) on the dynamic changes in plaque phenotype.
METHODS
Patients with myocardial infarction that had intravascular ultrasound-virtual histology (IVUS-VH) and optical coherence tomography (OCT) at baseline and 13-month follow-up were studied. The IVUS-VH data were used to reconstruct the nonculprit vessels, and in the obtained models the ESS was estimated in 3 mm segments. Plaque morphology was derived in each segment from IVUS-VH and OCT. Disease progression was defined as the presence of ≥2 out of the following criteria: reduction in lumen area, increase in plaque burden and change of plaque morphology to a more vulnerable phenotype. Linear mixed effects models were used to assess the effect of ESS in different phenotypes.
RESULTS
Sixty-eight vessels were included in the analysis. Low ESS was associated with plaque progression in all phenotypes. The effect of ESS on plaque burden (p for interaction=0.467) and phenotype (p for interaction=0.188) was similar in all plaque types, whereas the effect of ESS on the changes in lumen dimensions was more prominent in disease-free (β=0.70, p<0.001) than fibrotic/fibrocalcific (β=0.28, p<0.001) or lipid-rich plaques (β=0.15, p=0.015). Standalone IVUS-VH misclassified plaque morphology in one-third of the cases leading to erroneous estimations about the effect of ESS on plaque evolution in different phenotypes.
CONCLUSIONS
The effect of ESS on plaque progression is similar in all phenotypes and cannot be accurately assessed by standalone IVUS-VH which often misclassifies plaque morphology. Therefore, multimodality imaging should be considered to examine the implications of ESS on plaque evolution.
CLINICAL TRIAL REGISTRATION
NCT00962416; Post-results.",2019,"The effect of ESS on plaque burden (p for interaction=0.467) and phenotype (p for interaction=0.188) was similar in all plaque types, whereas the effect of ESS on the changes in lumen dimensions was more prominent in disease-free (β=0.70, p<0.001) than fibrotic/fibrocalcific (β=0.28, p<0.001) or lipid-rich plaques (β=0.15, p=0.015).","['Patients with myocardial infarction that had intravascular ultrasound-virtual histology (IVUS-VH) and optical coherence tomography (OCT) at baseline and 13-month follow-up were studied', 'Sixty-eight vessels were included in the analysis']","['ESS', 'endothelial shear stress (ESS']","['Disease progression', 'phenotype of coronary plaques', 'plaque burden and change of plaque morphology', 'Plaque morphology', 'plaque progression', 'plaque burden']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",68.0,0.0429289,"The effect of ESS on plaque burden (p for interaction=0.467) and phenotype (p for interaction=0.188) was similar in all plaque types, whereas the effect of ESS on the changes in lumen dimensions was more prominent in disease-free (β=0.70, p<0.001) than fibrotic/fibrocalcific (β=0.28, p<0.001) or lipid-rich plaques (β=0.15, p=0.015).","[{'ForeName': 'Christos V', 'Initials': 'CV', 'LastName': 'Bourantas', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zanchin', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Sakellarios', 'Affiliation': 'Department of Materials Science and Engineering, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Karagiannis', 'Affiliation': 'Clinical Trial Unit, Institute of Social and Preventive Medicine, Bern, Switzerland.'}, {'ForeName': 'Anantharaman', 'Initials': 'A', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Yamaji', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Taniwaki', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Clinical Trial Unit, Institute of Social and Preventive Medicine, Bern, Switzerland.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Moschovitis', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Fotiadis', 'Affiliation': 'Department of Materials Science and Engineering, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Mihalis', 'Affiliation': 'Department of Cardiology, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Torii', 'Affiliation': 'Department of Mechanical Engineering, University College London, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, Imperial College London Institute of Clinical Sciences, London, UK.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, Columbia, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2018-314086']
3344,30892045,Proteomic Analysis of Human Plasma during Intermittent Fasting.,"Intermittent fasting (IF) increases lifespan and decreases metabolic disease phenotypes and cancer risk in model organisms, but the health benefits of IF in humans are less clear. Human plasma derived from clinical trials is one of the most difficult sample sets to analyze using mass spectrometry-based proteomics due to the extensive sample preparation required and the need to process many samples to achieve statistical significance. Here, we describe an optimized and accessible device (Spin96) to accommodate up to 96 StageTips, a widely used sample preparation medium enabling efficient and consistent processing of samples prior to LC-MS/MS. We have applied this device to the analysis of human plasma from a clinical trial of IF. In this longitudinal study employing 8-weeks IF, we identified significant abundance differences induced by the IF intervention, including increased apolipoprotein A4 (APOA4) and decreased apolipoprotein C2 (APOC2) and C3 (APOC3). These changes correlated with a significant decrease in plasma triglycerides after the IF intervention. Given that these proteins have a role in regulating apolipoprotein particle metabolism, we propose that IF had a positive effect on lipid metabolism through modulation of HDL particle size and function. In addition, we applied a novel human protein variant database to detect common protein variants across the participants. We show that consistent detection of clinically relevant peptides derived from both alleles of many proteins is possible, including some that are associated with human metabolic phenotypes. Together, these findings illustrate the power of accessible workflows for proteomics analysis of clinical samples to yield significant biological insight.",2019,"Intermittent fasting (IF) increases lifespan and decreases metabolic disease phenotypes and cancer risk in model organisms, but the health benefits of",[],[],"['increased apolipoprotein A4 (APOA4) and decreased apolipoprotein C2 (APOC2) and C3 (APOC3', 'plasma triglycerides']",[],[],"[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0052181', 'cui_str': 'Apolipoprotein A-IV'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}]",,0.0560949,"Intermittent fasting (IF) increases lifespan and decreases metabolic disease phenotypes and cancer risk in model organisms, but the health benefits of","[{'ForeName': 'Dylan J', 'Initials': 'DJ', 'LastName': 'Harney', 'Affiliation': 'Charles Perkins Centre, School of Life and Environmental Sciences , University of Sydney , Sydney , NSW 2006 , Australia.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Hutchison', 'Affiliation': 'Discipline of Medicine , University of Adelaide , Adelaide , SA 5005 , Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Hatchwell', 'Affiliation': 'Charles Perkins Centre, School of Life and Environmental Sciences , University of Sydney , Sydney , NSW 2006 , Australia.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Humphrey', 'Affiliation': 'Charles Perkins Centre, School of Life and Environmental Sciences , University of Sydney , Sydney , NSW 2006 , Australia.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'James', 'Affiliation': 'Charles Perkins Centre, School of Life and Environmental Sciences , University of Sydney , Sydney , NSW 2006 , Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hocking', 'Affiliation': 'Central Clinical School, Faculty of Medicine and Health , University of Sydney , Sydney , NSW 2006 , Australia.'}, {'ForeName': 'Leonie K', 'Initials': 'LK', 'LastName': 'Heilbronn', 'Affiliation': 'Discipline of Medicine , University of Adelaide , Adelaide , SA 5005 , Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Larance', 'Affiliation': 'Charles Perkins Centre, School of Life and Environmental Sciences , University of Sydney , Sydney , NSW 2006 , Australia.'}]",Journal of proteome research,['10.1021/acs.jproteome.9b00090']
3345,31042420,Impact of Consensus Molecular Subtype on Survival in Patients With Metastatic Colorectal Cancer: Results From CALGB/SWOG 80405 (Alliance).,"PURPOSE
To determine the predictive and prognostic value of the consensus molecular subtypes (CMSs) of colorectal cancer (CRC) that represent a merging of gene expression-based features largely in primary tumors from six independent classification systems and provide a framework for capturing the intrinsic heterogeneity of CRC in patients enrolled in CALGB/SWOG 80405.
PATIENTS AND METHODS
CALGB/SWOG 80405 is a phase III trial that compared the addition of bevacizumab or cetuximab to infusional fluorouracil, leucovorin, and oxaliplatin or fluorouracil, leucovorin, and irinotecan as first-line treatment of advanced CRC. We characterized the CMS classification using a novel NanoString gene expression panel on primary CRCs from 581 patients enrolled in this study to assess the prognostic and predictive value of CMSs in these patients.
RESULTS
The CMSs are highly prognostic for overall survival (OS; P < .001) and progression-free survival (PFS; P < .001). Furthermore, CMSs were predictive for both OS ( P for interaction < .001) and PFS ( P for interaction = .0032). In the CMS1 cohort, patients treated with bevacizumab had a significantly longer OS than those treated with cetuximab ( P < .001). In the CMS2 cohort, patients treated with cetuximab had a significantly longer OS than patients treated with bevacizumab ( P = .0046).
CONCLUSION
These findings highlight the possible clinical utility of CMSs and suggests that refinement of the CMS classification may provide a path toward identifying patients with metastatic CRC who are most likely to benefit from specific targeted therapy as part of the initial treatment.",2019,The CMSs are highly prognostic for overall survival (OS; P < .001) and progression-free survival (PFS; P < .001).,"['581 patients enrolled', 'patients with metastatic CRC', 'advanced CRC', 'Patients With Metastatic Colorectal Cancer']","['cetuximab', 'bevacizumab or cetuximab to infusional fluorouracil, leucovorin, and oxaliplatin or fluorouracil, leucovorin, and irinotecan', 'bevacizumab']","['longer OS', 'PFS', 'progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",581.0,0.0554368,The CMSs are highly prognostic for overall survival (OS; P < .001) and progression-free survival (PFS; P < .001).,"[{'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': '1University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': '3University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': '4Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': '5Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': '6West Virginia University Cancer Institute, Morgantown, WV.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': '7Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ""8Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': '9Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': '10Genentech, San Francisco, CA.'}, {'ForeName': 'Pratyaksha', 'Initials': 'P', 'LastName': 'Wirapati', 'Affiliation': '11Swiss Institute of Bioinformatics, Lausanne, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': '12Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': '13The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Kabbarah', 'Affiliation': '10Genentech, San Francisco, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02258']
3346,32491239,MRI-Based Radiomics Signature: A Potential Biomarker for Identifying Glypican 3-Positive Hepatocellular Carcinoma.,"BACKGROUND
Glypican 3 (GPC3) expression has proved to be a critical risk factor related to prognosis in hepatocellular carcinoma (HCC) patients.
PURPOSE
To investigate the performance of MRI-based radiomics signature in identifying GPC3-positive HCC.
STUDY TYPE
Retrospective.
POPULATION
An initial cohort of 293 patients with pathologically confirmed HCC was involved in this study, and patients were randomly divided into training (195) and validation (98) cohorts.
FIELD STRENGTH/SEQUENCES
Contrast-enhanced T 1 -weight MRI was performed with a 1.5T scanner.
ASSESSMENT
A total of 853 radiomic features were extracted from the volume imaging. Univariate analysis and Fisher scoring were utilized for feature reduction. Subsequently, forward stepwise feature selection and radiomics signature building were performed based on a support vector machine (SVM). Incorporating independent risk factors, a combined nomogram was developed by multivariable logistic regression modeling.
STATISTICAL TESTS
The predictive performance of the nomogram was calculated using the area under the receive operating characteristic curve (AUC). Decision curve analysis (DCA) was applied to estimate the clinical usefulness.
RESULTS
The radiomics signature consisting of 10 selected features achieved good prediction efficacy (training cohort: AUC = 0.879, validation cohort: AUC = 0.871). Additionally, the combined nomogram integrating independent clinical risk factor α-fetoprotein (AFP) and radiomics signature showed improved calibration and prominent predictive performance with AUCs of 0.926 and 0.914 in the training and validation cohorts, respectively.
DATA CONCLUSION
The proposed MR-based radiomics signature is strongly related to GPC3-positive. The combined nomogram incorporating AFP and radiomics signature may provide an effective tool for noninvasive and individualized prediction of GPC3-positive in patients with HCC.",2020,"The radiomics signature consisting of 10 selected features achieved good prediction efficacy (training cohort: AUC = 0.879, validation cohort: AUC = 0.871).","['hepatocellular carcinoma (HCC) patients', 'patients with HCC', '293 patients with pathologically confirmed HCC']",['MRI-Based Radiomics Signature'],['clinical risk factor α-fetoprotein (AFP'],"[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015950', 'cui_str': 'Fetoprotein'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}]",293.0,0.0291323,"The radiomics signature consisting of 10 selected features achieved good prediction efficacy (training cohort: AUC = 0.879, validation cohort: AUC = 0.871).","[{'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Gu', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Wencui', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}, {'ForeName': 'Zhaoxiang', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}, {'ForeName': 'Zhongyuan', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xubin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27199']
3347,32485917,Tibial Nerve Block: Supramalleolar or Retromalleolar Approach? A Randomized Trial in 110 Participants.,"Of the five nerves that innervate the foot, the one in which anesthetic blocking presents the greatest difficulty is the tibial nerve. The aim of this clinical trial was to establish a protocol for two tibial nerve block anesthetic techniques to later compare the anesthetic efficiency of retromalleolar blocking and supramalleolar blocking in order to ascertain whether the supramalleolar approach achieved a higher effective blocking rate. A total of 110 tibial nerve blocks were performed. Location of the injection site was based on a prior ultrasound assessment of the tibial nerve. The block administered was 3 mL of 2% mepivacaine. The two anesthetic techniques under study provided very similar clinical results. The tibial nerve success rate was 81.8% for the retromalleolar technique and 78.2% for the supramalleolar technique. No significant differences in absolute latency time ( p = 0.287), percentage of effective nerve blocks ( p = 0.634), anesthetic block duration ( p = 0.895), or pain level during puncture ( p = 0.847) were found between the two techniques. The greater ease in locating the tibial nerve at the retromalleolar approach could suggest that this is the technique of choice for tibial nerve blocking, especially in the case of professionals new to the field. The supramalleolar technique could be worth considering for those more experienced professionals.",2020,"No significant differences in absolute latency time ( p = 0.287), percentage of effective nerve blocks ( p = 0.634), anesthetic block duration ( p = 0.895), or pain level during puncture ( p = 0.847) were found between the two techniques.",['110 Participants'],['mepivacaine'],"['absolute latency time', 'pain level', 'tibial nerve success rate', 'anesthetic block duration', 'percentage of effective nerve blocks']","[{'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]",110.0,0.0376973,"No significant differences in absolute latency time ( p = 0.287), percentage of effective nerve blocks ( p = 0.634), anesthetic block duration ( p = 0.895), or pain level during puncture ( p = 0.847) were found between the two techniques.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Benimeli-Fenollar', 'Affiliation': 'Department of Nursing, University of Valencia, c/Jaume Roig s/n, 46010 Valencia, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Montiel-Company', 'Affiliation': 'Department of Stomatology, University of Valencia, c/Gascó Oliag, 1, 46010 Valencia, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Almerich-Silla', 'Affiliation': 'Department of Stomatology, University of Valencia, c/Gascó Oliag, 1, 46010 Valencia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Cibrián', 'Affiliation': 'Department of Physiology, University of Valencia, c/Blasco Ibánez, 15, 46010 Valencia, Spain.'}, {'ForeName': 'Cecili', 'Initials': 'C', 'LastName': 'Macián-Romero', 'Affiliation': 'Department of Nursing, University of Valencia, c/Jaume Roig s/n, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17113860']
3348,32485945,"Sprint Interval Running and Continuous Running Produce Training Specific Adaptations, Despite a Similar Improvement of Aerobic Endurance Capacity-A Randomized Trial of Healthy Adults.","The purpose of the present study was to investigate training-specific adaptations to eight weeks of moderate intensity continuous training (CT) and sprint interval training (SIT). Young healthy subjects ( n = 25; 9 males and 16 females) performed either continuous training (30-60 min, 70-80% peak heart rate) or sprint interval training (5-10 near maximal 30 s sprints, 3 min recovery) three times per week for eight weeks. Maximal oxygen consumption, 20 m shuttle run test and 5·60 m sprint test were performed before and after the intervention. Furthermore, heart rate, oxygen pulse, respiratory exchange ratio, lactate and running economy were assessed at five submaximal intensities, before and after the training interventions. Maximal oxygen uptake increased after CT (before: 47.9 ± 1.5; after: 49.7 ± 1.5 mL·kg -1 ·min -1 , p < 0.05) and SIT (before: 50.5 ± 1.6; after: 53.3 ± 1.5 mL·kg -1 ·min -1 , p < 0.01), with no statistically significant differences between groups. Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p < 0.05). At submaximal intensities, CT, but not SIT, reduced heart rate ( p < 0.05), whereas lactate decreased in both groups. In conclusion, both groups demonstrated similar improvements of several performance measures including VO 2max , but sprint performance was better after SIT, and CT caused training-specific adaptations at submaximal intensities.",2020,"Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p < 0.05).","['Healthy Adults', 'Young healthy subjects ( n = 25; 9 males and 16 females']","['continuous training', 'moderate intensity continuous training (CT) and sprint interval training (SIT', 'Sprint Interval Running and Continuous Running Produce Training Specific Adaptations', 'sprint interval training']","['Maximal oxygen consumption, 20 m shuttle run test and 5·60 m sprint test', 'lactate', 'Maximal oxygen uptake', 'heart rate', 'Furthermore, heart rate, oxygen pulse, respiratory exchange ratio, lactate and running economy', '20 m shuttle run performance and 60 m sprint performance', 'several performance measures including VO 2max , but sprint performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.025306,"Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p < 0.05).","[{'ForeName': 'Sigbjørn', 'Initials': 'S', 'LastName': 'Litleskare', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Eystein', 'Initials': 'E', 'LastName': 'Enoksen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sandvei', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Støen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Stensrud', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Egil', 'Initials': 'E', 'LastName': 'Johansen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17113865']
3349,32479750,A Randomized Controlled Trial of the Lowest Effective Dose of Acetazolamide for Acute Mountain Sickness Prevention.,"BACKGROUND
Acetazolamide is the most common medication used for acute mountain sickness prevention, with speculation that a reduced dose may be as efficacious as standard dosing with fewer side effects.
METHODS
This double-blind, randomized, controlled non-inferiority trial compared acetazolamide 62.5 mg twice daily to the standard dose acetazolamide 125 mg twice daily starting the evening prior to ascent from 1,240 m (4,100 ft) to 3,810 m (12,570 ft) over 4 hours. The primary outcome was acute mountain sickness incidence (headache and Lake Louise Questionnaire ≥ 3 and another symptom).
RESULTS
106 participants were analyzed, with 51 (48%) randomized to 125 mg and 55 (52%) to 62.5 mg, with a combined acute mountain sickness incidence of 53 (50%) and mean severity of 3 (± 2.1). The 62.5 mg group failed to fall within the pre-specified 26% non-inferiority margin for acute mountain sickness incidence [62.5 mg = 30 (55%) versus 125 mg = 23 (45%), 95% CI -11% to 30%]. Participants in the 62.5 mg group had a higher risk of acute mountain sickness (OR = 1.5, 95% CI 0.7 to 3.2) and moderate acute mountain sickness (OR = 1.8, 95% CI 0.6 to 5.9), with a NNH of 9, with a NNT in the 125 mg group of 4.8. Increased acute mountain sickness incidence and symptom severity corresponded to lower weight-based and body mass index dosing, with similar side effects between groups.
CONCLUSION
Acetazolamide 62.5 mg twice daily failed to demonstrate equal effectiveness to 125 mg twice daily for prevention of acute mountain sickness. With increased risk and no demonstrable symptomatic or physiologic benefits, acetazolamide 62.5 mg twice daily should not be recommended for acute mountain sickness prevention.",2020,"Participants in the 62.5 mg group had a higher risk of acute mountain sickness (OR = 1.5, 95% CI 0.7 to 3.2) and moderate acute mountain sickness (OR = 1.8, 95% CI 0.6 to 5.9), with a NNH of 9, with a NNT in the 125 mg group of 4.8.","['106 participants', 'Acute Mountain Sickness Prevention']","['acetazolamide', 'Acetazolamide']","['higher risk of acute mountain sickness', 'acute mountain sickness incidence and symptom severity', 'moderate acute mountain sickness', 'acute mountain sickness incidence', 'acute mountain sickness incidence (headache and Lake Louise Questionnaire ≥ 3 and another symptom']","[{'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",106.0,0.0551059,"Participants in the 62.5 mg group had a higher risk of acute mountain sickness (OR = 1.5, 95% CI 0.7 to 3.2) and moderate acute mountain sickness (OR = 1.8, 95% CI 0.6 to 5.9), with a NNH of 9, with a NNT in the 125 mg group of 4.8.","[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Lipman', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine. Electronic address: grantlip@hotmail.com.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Jurkiewicz', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Burnier', 'Affiliation': 'Stanford University Emergency Medicine Residency, Stanford University School of Medicine.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marvel', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Department of Computational Science, University of Colorado.'}, {'ForeName': 'Cassie', 'Initials': 'C', 'LastName': 'Lowry', 'Affiliation': 'MountainView Regional Medical Center.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hawkins', 'Affiliation': 'Stanford University School of Medicine.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Navlyt', 'Affiliation': 'Stanford University Emergency Medicine Residency, Stanford University School of Medicine.'}, {'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Swenson', 'Affiliation': 'Medical Service, VA Puget Sound Health Care System, and Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.05.003']
3350,32479786,"Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial.","BACKGROUND
The role of neuroleptics for terminal agitated delirium is controversial. We assessed the effect of three neuroleptic strategies on refractory agitation in patients with cancer with terminal delirium.
METHODS
In this single-centre, double-blind, parallel-group, randomised trial, patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose haloperidol, were randomly assigned to receive intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1 mg and chlorpromazine at 12·5 mg every 4 h, until death or discharge. Rescue doses identical to the scheduled doses were administered at inception, and then hourly as needed. Permuted block randomisation (block size six; 1:1:1) was done, stratified by baseline Richmond Agitation Sedation Scale (RASS) scores. Research staff, clinicians, patients, and caregivers were masked to group assignment. The primary outcome was change in RASS score from time 0 to 24 h. Comparisons among group were done by modified intention-to-treat analysis. This completed study is registered with ClinicalTrials.gov, NCT03021486.
FINDINGS
Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14). RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3 [-4·4 to -2·2]), and combination group (n=10, -3·0 [-4·6 to -1·4]), with no difference among groups (p=0·71). The most common serious toxicity was hypotension (escalation n=6 [40%], rotation n=5 [31%], combination n=3 [21%]); there were no treatment-related deaths.
INTERPRETATION
Our data provide preliminary evidence that the three strategies of neuroleptics might reduce agitation in patients with terminal agitation. These findings are in the context of the single-centre design, small sample size, and lack of a placebo-only group.
FUNDING
National Institute of Nursing Research.",2020,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","['patients with terminal agitation', 'patients with cancer and delirium at an acute palliative care unit', 'Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14', 'patients with cancer with terminal delirium', 'patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose']","['neuroleptic strategies', 'Neuroleptic strategies', 'haloperidol', 'intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1\u2008mg and chlorpromazine']","['mean RASS score change', 'RASS score', 'Agitation Sedation Scale (RASS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087165', 'cui_str': 'Terminal agitation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",998.0,0.653147,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: dhui@mdanderson.org.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'De La Rosa', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Delgado-Guay', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Azhar', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Arthur', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Epner', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'De La Cruz', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Heung', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kimberson', 'Initials': 'K', 'LastName': 'Tanco', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of Investigational Pharmacy, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Neuro-Oncology Branch, Centre for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30307-7']
3351,32479794,"Tepotinib plus gefitinib in patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study): an open-label, phase 1b/2, multicentre, randomised trial.","BACKGROUND
We evaluated the efficacy and safety of tepotinib, a potent and highly selective oral MET inhibitor, plus gefitinib in patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition.
METHODS
In this open-label, phase 1b/2, multicentre, randomised trial (the INSIGHT study), we enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries. In phase 1b, patients received oral tepotinib 300 mg or 500 mg plus gefitinib 250 mg once daily. In phase 2, patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification were randomly assigned (initially in a 1:1 ratio and then 2:1 following a protocol amendment) to tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy. Randomisation was done centrally via an interactive voice-response system. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. Subgroup analyses were preplanned in patients with high MET overexpression (IHC3+) or MET amplification (mean gene copy number ≥5 or MET to centromere of chromosome 7 ratio ≥2). Efficacy and patient characteristics were assessed on an intention-to-treat basis and safety was assessed for all patients who received at least one dose of study medication. Low recruitment led to early termination of phase 2, so all analyses are considered to be exploratory. This study is registered with ClinicalTrials.gov, NCT01982955, and the European Union Drug Regulating Authorities Clinical Trials Database, Eudra-CT 2016-001604-28.
FINDINGS
From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group; n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group; n=24 in the chemotherapy group). No dose-limiting toxicities were observed in phase 1b, so tepotinib 500 mg was used as the recommended phase 2 dose. In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio [HR] 0·67, 90% CI 0·35-1·28). Median OS was 17·3 months in the tepotinib plus gefitinib group (12·1-37·3) versus 18·7 months in the chemotherapy group (15·9-20·7; HR 0·69, 0·34-1·41). PFS and OS were longer with tepotinib plus gefitinib than with chemotherapy in patients with high (IHC3+) MET overexpression (n=34; median PFS 8·3 months [4·1-16·6] vs 4·4 months [4·1-6·8]; HR 0·35, 0·17-0·74; median OS 37·3 months [90% CI 24·2-37·3] vs 17·9 months [12·0-20·7]; HR 0·33, 0·14-0·76) or MET amplification (n=19; median PFS 16·6 months [8·3-not estimable] vs 4·2 months [1·4-7·0]; HR 0·13, 0·04-0·43; median OS 37·3 months [90% CI not estimable] vs 13·1 months [3·25-not estimable]; HR 0·08, 0·01-0·51). The most frequent treatment-related grade 3 or worse adverse events were increased amylase (5 [16%] of 31 patients) and lipase (4 [13%]) concentrations in the tepotinib plus gefitinib group and anaemia (7 [30%] of 23 patients) and decreased neutrophil count (3 [13%]) in the chemotherapy group.
INTERPRETATION
Despite early study termination, in a preplanned subgroup analysis, our findings suggest improved anti activity for tepotinib plus gefitinib compared with standard chemotherapy in patients with EGFR-mutant NSCLC and MET amplification, warranting further exploration.
FUNDING
Merck KGaA.",2020,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","['From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group', 'patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition', 'patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study', 'n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group', 'patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification', 'n=24 in the chemotherapy group', 'enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries']","['Tepotinib plus gefitinib', 'standard chemotherapy', 'oral tepotinib 300 mg or 500 mg plus gefitinib', 'tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy']","['investigator-assessed progression-free survival (PFS', 'anti activity', 'Median OS', 'neutrophil count', 'median PFS', 'anaemia', 'intention-to-treat basis and safety', 'adverse events', 'PFS and OS', 'No dose-limiting toxicities', 'overall survival (OS) and safety', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0454705', 'cui_str': 'Asian country'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",18.0,0.166598,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","[{'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: syylwu@live.cn.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Province Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Chest Hospital, Shanghai, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ross Andrew', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'National University Cancer Institute, Singapore.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital, Zhejiang Medical University, Zhejiang, China.'}, {'ForeName': 'Yuh-Min', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'Department of Chest Medicine, Taipei Veteran General Hospital and School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chih-Feng', 'Initials': 'CF', 'LastName': 'Chian', 'Affiliation': 'Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Daniel Shao Weng', 'Initials': 'DSW', 'LastName': 'Tan', 'Affiliation': 'National Cancer Center, Singapore.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bruns', 'Affiliation': 'Biostatistics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Straub', 'Affiliation': 'Translational Medicine, Department of Clinical Biomarkers and Companion Diagnostics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Johne', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Scheele', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30154-5']
3352,32479807,Short-term prediction error with single-piece acrylic IOL Receiving 1 of 3 Types of Single-Piece Acrylic Intraocular Lenses.,"PURPOSE
To compare short-term changes in the refractive prediction error (PE) after phacoemulsification among eyes receiving different types of single-piece acrylic intraocular lenses (IOLs).
DESIGN
Randomized clinical trial.
METHODS
One-hundred ninety-five eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL were randomly assigned to receive 1 of 3 IOLs: 1) Alcon SN60WF, 2) HOYA XY-1, or 3) AMO ZCB00V. Manifest spherical equivalent value (MRSE), PE, and changes in PE were examined at 1 day, and 1 and 2 months postoperatively, and compared among groups.
RESULTS
The mean MRSE and PE significantly changed toward myopia between 1 day and 2 months postoperatively in all groups (P<.0001). The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006). The PE change between 1 day and 2 months postoperatively was significantly smaller in the SN60WF group than in the other groups (P=.0062). IOL type, and changes in anterior chamber depth and corneal curvature independently correlated with PE changes.
CONCLUSIONS
The MRSE and PE showed a significant myopic change for 2 months postoperatively in eyes implanted with 1 of 3 types of single-piece acrylic IOLs, and were significantly smaller with the SN60WF than with the XY-1 and ZCB00V. Changes in PE during the 2 postoperative months were smaller with the SN60WF than with the other IOLs, suggesting that postoperative refractive stability differs among single-piece acrylic IOLs.",2020,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","['One-hundred ninety-five eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL', 'eyes receiving different types of single-piece acrylic intraocular lenses (IOLs']",['SN60WF'],"['PE change', 'IOL type, and changes in anterior chamber depth and corneal curvature', 'mean MRSE and PE', 'MRSE and PE', 'AMO ZCB00V. Manifest spherical equivalent value (MRSE), PE, and changes in PE', 'refractive prediction error (PE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",195.0,0.0496226,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan. Electronic address: hayashi-ken@hayashi.or.jp.'}, {'ForeName': 'Motoaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Hayashi', 'Affiliation': 'Department of Ophthalmology, Keio University Faculty of Medicine.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.05.031']
3353,32480417,von Willebrand Factor and Factor VIII Clearance in Perioperative Hemophilia A Patients.,"BACKGROUND
von Willebrand factor (VWF) is crucial for optimal dosing of factor VIII (FVIII) concentrate in hemophilia A patients as it protects FVIII from premature clearance. To date, it is unknown how VWF behaves and what its impact is on FVIII clearance in the perioperative setting.
AIM
To investigate VWF kinetics (VWF antigen [VWF:Ag]), VWF glycoprotein Ib binding (VWF:GPIbM), and VWF propeptide (VWFpp) in severe and moderate perioperative hemophilia A patients included in the randomized controlled perioperative OPTI-CLOT trial.
METHODS
Linear mixed effects modeling was applied to analyze VWF kinetics. One-way and two-way analyses of variance were used to investigate perioperative VWFpp/VWF:Ag ratios and associations with surgical bleeding.
RESULTS
Fifty-nine patients with median age of 48.8 years (interquartile range: 34.8-60.0) were included. VWF:Ag and VWF:GPIbM increased significantly postoperatively. Blood type non-O or medium risk surgery were associated with higher VWF:Ag and VWF:GPIbM levels compared with blood type O and low risk surgery. VWFpp/VWF:Ag was significantly higher immediately after surgery than 32 to 57 hours after surgery ( p < 0.001). Lowest VWF:Ag quartile (0.43-0.92 IU/mL) was associated with an increase of FVIII concentrate clearance of 26 mL/h (95% confidence interval: 2-50 mL/h) compared with highest VWF antigen quartile (1.70-3.84 IU/mL). VWF levels were not associated with perioperative bleeding F (4,227) = 0.54, p = 0.710.
CONCLUSION
VWF:Ag and VWF:GPIbM levels increase postoperatively, most significantly in patients with blood type non-O or medium risk surgery. Lower VWF antigen levels did not lead to clinically relevant higher FVIII clearance. VWF:Ag or VWF:GPIbM levels were not associated with perioperative hemorrhage.",2020,"VWF levels were not associated with perioperative bleeding F (4,227) = 0.54, p = 0.710.
","['Fifty-nine patients with median age of 48.8 years (interquartile range: 34.8-60.0) were included', 'Perioperative Hemophilia A Patients', 'severe and moderate perioperative hemophilia', 'patients with blood type non-O or medium risk surgery', 'hemophilia']","['Blood type non-O or medium risk surgery', 'VWFpp/VWF', 'VWF', 'Ag or VWF', 'VWF glycoprotein', 'factor VIII ', 'Ag and VWF', 'Ib binding (VWF:GPIbM), and VWF propeptide (VWFpp', 'Lowest VWF']","['FVIII concentrate clearance', 'VWF kinetics (VWF antigen ', 'Lower VWF antigen levels', 'VWF levels', 'von Willebrand Factor and Factor VIII Clearance', 'GPIbM levels', 'GPIbM']","[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005810', 'cui_str': 'Blood Groups'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0005810', 'cui_str': 'Blood Groups'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1318684', 'cui_str': 'von Willebrand factor antigen level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",59.0,0.0316008,"VWF levels were not associated with perioperative bleeding F (4,227) = 0.54, p = 0.710.
","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'van Moort', 'Affiliation': ""Department of Pediatric Hematology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Bukkems', 'Affiliation': 'Department of Clinical Pharmacology - Hospital Pharmacy, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Heijdra', 'Affiliation': ""Department of Pediatric Hematology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Roger E G', 'Initials': 'REG', 'LastName': 'Schutgens', 'Affiliation': 'Van Creveldkliniek, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Britta A P', 'Initials': 'BAP', 'LastName': 'Laros-van Gorkom', 'Affiliation': 'Department of Thrombosis and Hemostasis, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Nieuwenhuizen', 'Affiliation': 'Department of Internal Medicine, Maxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Felix J M', 'Initials': 'FJM', 'LastName': 'van der Meer', 'Affiliation': 'Division of Thrombosis and Hemostasis, Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Fijnvandraat', 'Affiliation': 'Department of Pediatric Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Moniek P M', 'Initials': 'MPM', 'LastName': 'de Maat', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank W G', 'Initials': 'FWG', 'LastName': 'Leebeek', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Meijer', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Eikenboom', 'Affiliation': 'Division of Thrombosis and Hemostasis, Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Ron A A', 'Initials': 'RAA', 'LastName': 'Mathôt', 'Affiliation': 'Department of Clinical Pharmacology - Hospital Pharmacy, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjon H', 'Initials': 'MH', 'LastName': 'Cnossen', 'Affiliation': ""Department of Pediatric Hematology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thrombosis and haemostasis,['10.1055/s-0040-1710591']
3354,32480437,"Safety, tolerability and efficacy of LEGA-Kid® mechanical percussion device versus conventional chest physiotherapy in children: a randomised, single-blind controlled study.","INTRODUCTION
Chest physiotherapy (CPT) may benefit children aged < 5 years who suffer from lower respiratory tract infection (LRTI). However, its effects are technique-dependent. This study aimed to determine whether mechanical CPT using the LEGA-Kid® mechanical percussion device is superior to manual CPT in children with LRTI.
METHODS
Children aged 5 months to 5 years who were admitted and referred for CPT from January to April 2017 were randomised to either manual CPT or mechanical CPT with LEGA-Kid®. Outcomes measured at pre-intervention and 2 hours post-intervention were respiratory rate (RR), oxygen saturation and modified Respiratory Distress Assessment Instrument (mRDAI) score.
RESULTS
All 30 enrolled patients had significant reduction in post-intervention RR and mRDAI scores. There was an 8% reduction in RR for the manual CPT group (p = 0.002) and a 16.5% reduction in the mechanical CPT group (p = 0.0001), with a significantly greater reduction in the latter (p = 0.024). mRDAI scores decreased by 2.96 in the manual group (p = 0.0001) and 3.62 in the mechanical group (p = 0.002), with no significant difference between the groups. There was no significant improvement in oxygen saturation, and no adverse events were observed after CPT.
CONCLUSION
Children receiving either manual or mechanical CPT showed improvements in respiratory distress symptoms with no adverse effects. A combined strategy of nebulised hypertonic saline followed by CPT for LRTI removes airway secretions and results in improvements of moderately severe respiratory distress. The LEGA-Kid mechanical CPT method was superior in reducing RR.",2020,"mRDAI scores decreased by 2.96 in the manual group (p = 0.0001) and 3.62 in the mechanical group (p = 0.002), with no significant difference between the groups.","['children with LRTI', 'children aged < 5 years who suffer from lower respiratory tract infection (LRTI', 'Children aged 5 months to 5 years who were admitted and referred for CPT from January to April 2017', 'children']","['LEGA-Kid® mechanical percussion device versus conventional chest physiotherapy', 'manual or mechanical CPT', 'LEGA-Kid® mechanical percussion device', 'Chest physiotherapy (CPT', 'manual CPT or mechanical CPT with LEGA-Kid®', 'nebulised hypertonic saline']","['moderately severe respiratory distress', 'Safety, tolerability and efficacy', 'oxygen saturation', 'respiratory rate (RR), oxygen saturation and modified Respiratory Distress Assessment Instrument (mRDAI) score', 'post-intervention RR and mRDAI scores', 'adverse events', 'respiratory distress symptoms', 'mRDAI scores', 'RR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",30.0,0.0435458,"mRDAI scores decreased by 2.96 in the manual group (p = 0.0001) and 3.62 in the mechanical group (p = 0.002), with no significant difference between the groups.","[{'ForeName': 'Yuen Ling', 'Initials': 'YL', 'LastName': 'Hue', 'Affiliation': 'University Malaya Paediatric and Child Health Research Group, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Lucy Chai See', 'Initials': 'LCS', 'LastName': 'Lum', 'Affiliation': 'Department of Paediatrics, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siti Hawa', 'Initials': 'SH', 'LastName': 'Ahmad', 'Affiliation': 'Physiotherapy Division, Department of Rehabilitation Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Soon Sin', 'Initials': 'SS', 'LastName': 'Tan', 'Affiliation': 'University Malaya Paediatric and Child Health Research Group, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Shin Yee', 'Initials': 'SY', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Nathan', 'Affiliation': 'Department of Paediatrics, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Kah Peng', 'Initials': 'KP', 'LastName': 'Eg', 'Affiliation': 'Department of Paediatrics, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Melissa de Bruyne Ming May', 'Initials': 'MBMM', 'LastName': 'Choon', 'Affiliation': 'University Malaya Paediatric and Child Health Research Group, University of Malaya, Kuala Lumpur, Malaysia.'}]",Singapore medical journal,['10.11622/smedj.2020084']
3355,32480568,Impact of fog drip versus fog immersion on the physiology of Bishop pine saplings.,"Fog-drip to the soil is the most obvious contribution of fog to the water budget of an ecosystem, but several studies provide convincing evidence that foliar absorption of fog water through leaf wetting events is also possible. The focus of our research was to assess the relative importance of fog drip and fog immersion (foliar wetting) on leaf gas-exchange rates and photosynthetic capacity of a coastal pine species, Bishop pine (Pinus muricata D.Don), a drought-sensitive species restricted to the fog belt of coastal California and offshore islands. In a controlled experiment, we manipulated fog water inputs to potted Bishop pine saplings during a 3 week dry-down period. Ten saplings were randomly assigned one of two fog treatments: (1) fog drip to the soil and canopy fog immersion, or (2) fog immersion alone. Five saplings were assigned the 'control' group and received no fog water inputs. We found that fog immersion alone significantly increased carbon assimilation rates and photosynthetic capacity of saplings as soil moisture declined compared with those that received no fog at all. The highest carbon assimilation rates were observed in saplings that also received fog drip. Soil moisture was 40% higher in the fog immersion compared with the control group during the dry-down, indicating a reduced demand for soil water in saplings that had only leaves wetted by canopy interception of fog. Leaf-level physiology is more strongly enhanced by fog drip compared with fog immersion, although the results of this study provide evidence that foliar absorption is a viable mechanism by which Bishop pines use fog water and that it can enhance instantaneous plant carbon gain and potentially whole plant productivity.",2017,"Soil moisture was 40% higher in the fog immersion compared with the control group during the dry-down, indicating a reduced demand for soil water in saplings that had only leaves wetted by canopy interception of fog.",[],"['fog drip versus fog immersion', 'fog drip and fog immersion (foliar wetting', 'fog drip to the soil and canopy fog immersion, or (2) fog immersion alone', 'no fog water inputs']","['highest carbon assimilation rates', 'Soil moisture', 'carbon assimilation rates and photosynthetic capacity of saplings as soil moisture']",[],"[{'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0162598', 'cui_str': 'Wetability'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C1704301', 'cui_str': 'Assimilation, Cultural'}, {'cui': 'C0037592', 'cui_str': 'Soil'}]",10.0,0.027516,"Soil moisture was 40% higher in the fog immersion compared with the control group during the dry-down, indicating a reduced demand for soil water in saplings that had only leaves wetted by canopy interception of fog.","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Baguskas', 'Affiliation': 'University of California Santa Cruz, Department of Environmental Studies, 1156 High Street, Santa Cruz, CA 95064, USA.'}, {'ForeName': 'Jennifer Y', 'Initials': 'JY', 'LastName': 'King', 'Affiliation': 'University of California Santa Barbara, Department of Geography, 1832 Ellison Hall, Santa Barbara, CA 93106-4060, USA.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Fischer', 'Affiliation': 'University of California Santa Barbara, Department of Geography, 1832 Ellison Hall, Santa Barbara, CA 93106-4060, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'D Antonio', 'Affiliation': 'University of California Santa Barbara, Department of Ecology, Evolution, and Marine Biology, Santa Barbara, CA 93106, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Still', 'Affiliation': 'Oregon State University, Department of Forest Ecosystems and Society, 321 Richardson Hall, Corvallis, OR 97331, USA.'}]",Functional plant biology : FPB,['10.1071/FP16234']
3356,32481236,Acute responses of bone specific and related markers to maximal eccentric exercise of the knee extensors and flexors in young men.,"OBJECTIVES
The present study determined time-course changes in plasma bone-specific and -related markers following a bout of maximal eccentric contractions (MaxEC) of bilateral knee extensors (KE) and flexors (KF).
METHODS
Sedentary young men (n=30) performed a bout of 10 sets of 10 MaxEC (30°/s) of KE and KF with each leg, respectively. Maximal voluntary isometric contraction (MVC) torque, muscle soreness (SOR), plasma creatine kinase (CK) activity, insulin, leptin, tumor necrosis factor-α (TNF-α), undercarboxylated-osteocalcin (ucOCN), carboxy-terminal crosslinking telopeptide of type I collagen (CTX-1) and procollagen type I N-terminal propeptide (P1NP) concentrations were measured from before to 7 days after MaxEC.
RESULTS
Significant changes in MVC (KE: -28%, KF: -38%), SOR and plasma CK activity (peak: 39,163 IU/L) following MaxEC were evident (P<0.05) compared to baseline. Plasma leptin (17%) concentrations decreased at 1 day after MaxEC. In bone related markers, plasma ucOCN concentrations (20%) increased at 7 days after MaxEC, and plasma CTX-1 concentrations decreased at 2, 4 and 7 days after MaxEC (6~7%; P<0.05).
CONCLUSION
These results demonstrate that a lean effect of bone generation and an enhanced energy anabolism can be induced by a single bout of MaxEC.",2020,"concentrations decreased at 2, 4 and 7 days after MaxEC (6~7%; P<0.05).
","['Sedentary young men (n=30', 'young men']","['bone specific and related markers to maximal eccentric exercise', 'bilateral knee extensors (KE) and flexors (KF', 'I collagen (CTX-1) and procollagen type', 'maximal eccentric contractions (MaxEC']","['concentrations', 'plasma ucOCN concentrations', 'plasma CTX-1', 'Plasma leptin (17%) concentrations', 'Maximal voluntary isometric contraction (MVC) torque, muscle soreness (SOR), plasma creatine kinase (CK) activity, insulin, leptin, tumor necrosis factor-α (TNF-α), undercarboxylated-osteocalcin (ucOCN), carboxy-terminal crosslinking telopeptide of type', 'P1NP) concentrations', 'SOR and plasma CK activity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",,0.0699251,"concentrations decreased at 2, 4 and 7 days after MaxEC (6~7%; P<0.05).
","[{'ForeName': 'Tsang-Hai', 'Initials': 'TH', 'LastName': 'Huang', 'Affiliation': 'Institute of Physical Education, Health and Leisure Studies, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Jung-Charng', 'Initials': 'JC', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Education, Chinese Culture University, Taipei City, Taiwan.'}, {'ForeName': 'Mi-Chia', 'Initials': 'MC', 'LastName': 'Ma', 'Affiliation': 'Department of Statistics, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Tsung', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Public Health College of Medicine, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Trevor C', 'Initials': 'TC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei City, Taiwan.'}]",Journal of musculoskeletal & neuronal interactions,[]
3357,32481262,"Radiological diagnostic accuracy study comparing Lenke, Bridwell, BSF, and CT-HU fusion grading scales for minimally invasive lumbar interbody fusion spine surgery and its correlation to clinical outcome.","Prospective randomized double-blinded diagnostic accuracy study about radiological grading of fusion after minimally invasive lumbar interbody fusion procedures (MI-LIFP).To determinate the intra and the inter-observer correlation between different radiological lumbar interbody fusion grading scales (RLIFGS) in patients undergoing MI-LIFP and their correlation to clinical outcome.Besides technological improvements in medical diagnosis and the many existing RLIFGS, surgical exploration continues to be the gold-standard to assess fusion in patients with radiological pseudarthrosis, with little if any research on the relationship between RLIFGS and clinical outcome.We collected data from patients undergoing MI-LIFP procedures operated by a single surgeon from 2009 to 2017, which had follow-up and CT-scan control greater than 12 months, whose clinical registers specified lumbar and radicular visual analogue scale (L and R-VAS) and Oswestry Disability Index (ODI) score preoperatively and at the end of follow-up. Interbody fusion levels were coded for blinded evaluation by three different minimally invasive spine (MIS) surgeons, using Lenke, Bridwell, BSF (Brantigan, Steffe, Fraser), and CT-HU RLIFGS. We established fusion criteria, as described in their original papers. Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis. Radiological and clinical data was coded and statistically analyzed using Student T-Test, Pearson P-Test, and ANOVA with statistical package for the social sciences 21 by another blinded researcher, positive and negative predictive values were also calculated for each RLFGS.We found a significant clinical improvement with a moderate intra-observer correlation between scales and no inter-observer or clinical correlation, with no sub-group statistically significant differences.This paper represents the first study about the diagnostic accuracy of RLFGS, we concluded that their diagnostic accuracy is pretty low to determine fusion or pseudoarthrosis based on its low correlation to clinical outcome, we recommend surgeons rely on clinical findings to decide whether a patient has clinical fusion or pseudoarthrosis based on successful clinical outcome.",2020,"Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis.","['patients undergoing MI-LIFP procedures operated by a single surgeon from 2009 to 2017, which had follow-up and CT-scan control greater than 12 months, whose', 'patients undergoing MI-LIFP and their correlation to clinical outcome', 'patients with radiological pseudarthrosis']","['Lenke, Bridwell, BSF, and CT-HU fusion grading scales', 'RLFGS']","['successful clinical outcome (SCO', 'L-VAS, R-VAS, or ODI score', 'clinical registers specified lumbar and radicular visual analogue scale (L and R-VAS) and Oswestry Disability Index (ODI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1293131', 'cui_str': 'Fusion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033785', 'cui_str': 'Pseudoarthrosis'}]","[{'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0349849,"Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis.","[{'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Soriano Sánchez', 'Affiliation': 'Spine Clinic of The American-British Cowdray Medical Center IAP. Campus Santa Fe Mexican Association of Spine Surgeons (AMCICO) Mexican Society of Neurological Surgery (SMCN).'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Soriano Solís', 'Affiliation': 'Orthopedic Surgeon and Minimally Invasive Spine Surgeon of The American-British Cowdray Medical Center IAP., Campus Santa Fe.'}, {'ForeName': 'Manuel Eduardo', 'Initials': 'ME', 'LastName': 'Soto García', 'Affiliation': 'Neurosurgeon and Minimally Invasive Spine Surgeon of The American-British Cowdray Medical Center IAP., Campus Santa Fe.'}, {'ForeName': 'Héctor Antonio', 'Initials': 'HA', 'LastName': 'Soriano Solís', 'Affiliation': 'Orthopedic Surgeon of The American-British Cowdray Medical Center IAP., Campus Santa Fe.'}, {'ForeName': 'Briscia Yazmin Aranda', 'Initials': 'BYA', 'LastName': 'Torres', 'Affiliation': 'Student of Nutritional Sciences, University of Sonora (UNISON).'}, {'ForeName': 'José Alberto Israel', 'Initials': 'JAI', 'LastName': 'Romero Rangel', 'Affiliation': 'Neurosurgeon and Minimally Invasive Spine Surgeon of The American-British Cowdray Medical Center IAP. Campus Santa Fe Neurosurgeon of the Regional General Hospital #25, Mexican Institute of Social Security (HGR#25, IMSS).'}]",Medicine,['10.1097/MD.0000000000019979']
3358,32481275,Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE): A protocol of a randomized controlled trial for chronic musculoskeletal pain in cancer survivors.,"INTRODUCTION
Chronic pain is a leading cause of disability and remains under-treated in nearly half of patients with cancer. The opioid crisis has highlighted an urgent public health need for effective nonpharmacological pain management. Electroacupuncture (EA) and Battlefield Acupuncture (BFA) represent nonpharmacological modalities used in clinical practice to manage pain; however, their effectiveness has not been rigorously evaluated in oncology settings.
METHODS
We describe the design of a 3-arm, parallel, single-center, multisite randomized controlled trial that investigates EA and BFA versus usual-care wait-list control (WLC) for chronic musculoskeletal pain among 360 patients with diverse cancer types across various stages. The primary aim is to compare effects of EA and BFA versus WLC on pain, physical function, and co-morbid symptoms. The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction. The tertiary aim is to evaluate the association between genetic polymorphisms and responses to acupuncture. Patients will be randomized in a 2:2:1 ratio to EA:BFA:WLC. Acupuncture groups will receive weekly treatments over 10 weeks. WLC will receive usual care over the same evaluation period as the acupuncture groups. The primary endpoint will be the change in average pain intensity score from baseline to week 12. We will collect validated patient-reported outcomes and blood/saliva samples at multiple timepoints over 24 weeks.
DISCUSSION
Our findings will advance nonpharmacological pain management in oncology and inform personalized treatment approaches that integrate individuals' expectations and genetic biomarkers to deliver ""precision"" acupuncture to cancer patients with chronic pain.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02979574.",2020,The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction.,"['360 patients with diverse cancer types across various stages', 'chronic musculoskeletal pain in cancer survivors', 'cancer patients with chronic pain', 'patients with cancer']","['acupuncture', 'EA and BFA versus usual-care wait-list control (WLC', 'EA and BFA versus WLC', 'Acupuncture', 'acupuncture modality (EA vs BFA', 'Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE', 'Electroacupuncture (EA) and Battlefield Acupuncture (BFA', 'WLC']","['average pain intensity score', 'pain reduction', 'pain, physical function, and co-morbid symptoms']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",360.0,0.192384,The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction.,"[{'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Liou', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Baser', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Sally A D', 'Initials': 'SAD', 'LastName': 'Romero', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego School of Medicine, San Diego, CA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}, {'ForeName': 'Q Susan', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Orlow', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Panageas', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine.'}]",Medicine,['10.1097/MD.0000000000020085']
3359,32481277,The effect of Shexiang Tongxin Dropping Pills on coronary microvascular dysfunction (CMVD) among those with a mental disorder and non-obstructive coronary artery disease based on stress cardiac magnetic resonance images: A study protocol.,"INTRODUCTION
Coronary microvascular dysfunction (CMVD), highly prevalent among patients with a mental disorder (anxiety or depression), is closely related to adverse cardiac events, including hospitalization, sudden cardiac death, and myocardial infarction. Shexiang Tongxin Dropping Pills (STDP), a traditional Chinese medicine, exerts endothelial protective function by anti-inflammation, anti-oxidative stress, and promoting blood circulation. STDP protects against CMVD in previous fundamental studies. The present trial is aiming at evaluating the effect of STDP on CMVD among depressed or anxious patients with non-obstructive coronary artery disease (NOCAD).
METHODS AND ANALYSIS
Seventy-two depressed or anxious patients diagnosed with NOCAD combined with CMVD utilizing coronary artery angiography and stress cardiac magnetic resonance (CMR) will be recruited in the present study. These patients will be randomized into two groups, namely, Nicorandil group (Nicorandil combined with routine medicine), and STDP groups (STDP combined with routine medicine). The change of CMVD status by assessing absolute myocardial blood flow and myocardial reperfusion using stress CMR 3-month after discharge is defined as the primary endpoint. Major adverse cardiac events (MACEs), quality of life (QOL), and metal disorder improvement are defined as the secondary endpoints. Seattle angina questionnaire (SAQ) which is used to assess angina pectoris and QOL will be recorded at 1-, 3-, 6-, 9-, 12-month of follow-up. Seven-item Generalized Anxiety Disorder Scale (GAD-7) and 9-item depression module from the Patient Health Questionnaire (PHQ9) which utilized to evaluate anxiety and depression, respectively, will be recorded at 1-, 3-, 6-, 9-, 12-month of follow-up. This study will first evaluate the efficacy of STDP on CMVD among patients with a mental disorder and NOCAD, and discuss the potential mechanisms, providing therapeutic evidence for the STDP for these patients.",2020,The change of CMVD status by assessing absolute myocardial blood flow and myocardial reperfusion using stress CMR 3-month after discharge is defined as the primary endpoint.,"['anxious patients with non-obstructive coronary artery disease (NOCAD', 'patients with a mental disorder and NOCAD', 'those with a mental disorder and non-obstructive coronary artery disease', 'Seventy-two depressed or anxious patients diagnosed with NOCAD combined with CMVD utilizing coronary artery angiography and stress cardiac magnetic resonance (CMR', 'patients with a mental disorder (anxiety or depression']","['STDP', 'Shexiang Tongxin Dropping Pills', 'Nicorandil group (Nicorandil combined with routine medicine), and STDP groups (STDP combined with routine medicine', 'Shexiang Tongxin Dropping Pills (STDP']","['angina pectoris and QOL', 'Major adverse cardiac events (MACEs), quality of life (QOL), and metal disorder improvement', 'Seven-item Generalized Anxiety Disorder Scale (GAD-7) and 9-item depression module', 'Seattle angina questionnaire (SAQ', 'coronary microvascular dysfunction (CMVD']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3696962', 'cui_str': 'Coronary microvascular dysfunction'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C4079279', 'cui_str': 'shexiang tongxin'}, {'cui': 'C0440421', 'cui_str': 'Droppings'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3696962', 'cui_str': 'Coronary microvascular dysfunction'}]",72.0,0.0481841,The change of CMVD status by assessing absolute myocardial blood flow and myocardial reperfusion using stress CMR 3-month after discharge is defined as the primary endpoint.,"[{'ForeName': 'Jinfan', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Xueyao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Zuo', 'Affiliation': 'Department of Community Health Research, Beijing Anzhen Hospital, Capital Medical University.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Yong', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Radiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiantao', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology.'}]",Medicine,['10.1097/MD.0000000000020099']
3360,32481287,Clinical observation of Dan-Hong Hua-Yu oral solution in treating retinal vein occlusion.,"INTRODUCTION
Retinal vein occlusion refers to diseases with decreased vision, dilated tortuous retinal veins visible on the fundus, and retinal hemorrhage, edema, and osmosis distributed along the vein. There is still no ideal intervention to treat central retinal vein occlusion. This study plan to observe the efficacy of Dan-Hong Hua-Yu oral solution in treating non-ischemic retinal vein occlusion, in order to provide new treatment ideas.
METHODS/DESIGN
We plan to use random number table method, 64 cases of non-ischemic central retinal vein occlusion that meet the inclusion criteria will be randomly divided into a treatment group and a control group. The intervention group will be treated with Dan-Hong Hua-Yu oral solution according to the syndrome differentiation of Traditional Chinese medicine and the patient's fundus condition. Each group will take 4 weeks as a course of treatment and three consecutive courses of treatment without any interval during the course of treatment. Changes of visual acuity, fundus performance, and total clinical symptoms of patients before and after treatment will be observed.
DISCUSSION
This study will observe the efficacy of Dan-Hong Hua-Yu oral solution in the treatment of non-ischemic central retinal vein occlusion, with a view to providing new treatment ideas.
TRIAL REGISTRATION
ClinicalTrials.gov, ChiCTR2000030625, Registered on March 08, 2020.",2020,"This study will observe the efficacy of Dan-Hong Hua-Yu oral solution in the treatment of non-ischemic central retinal vein occlusion, with a view to providing new treatment ideas.
",['64 cases of non-ischemic central retinal vein occlusion that meet the inclusion criteria'],"['Dan-Hong Hua-Yu oral solution', ""Dan-Hong Hua-Yu oral solution according to the syndrome differentiation of Traditional Chinese medicine and the patient's fundus condition""]","['visual acuity, fundus performance, and total clinical symptoms']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0730361', 'cui_str': 'Central retinal vein occlusion - non-ischemic'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C1857276', 'cui_str': 'Trichohepatoenteric syndrome'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0455749,"This study will observe the efficacy of Dan-Hong Hua-Yu oral solution in the treatment of non-ischemic central retinal vein occlusion, with a view to providing new treatment ideas.
","[{'ForeName': 'Tie-Jun', 'Initials': 'TJ', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Sun', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Ma', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}, {'ForeName': 'Ying-Xin', 'Initials': 'YX', 'LastName': 'Yang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.'}]",Medicine,['10.1097/MD.0000000000020173']
3361,32481325,The success of opening concurrent chronic total occlusion lesion to improve cardiac function trial in patients with multi-vessel disease (SOS-moral): Study protocol of a prospective multicenter study.,"AIMS
The purpose of the present trial is to determine whether opening co-existing chronic total occlusions (CTOs) using percutaneous coronary interventions (PCIs) improves cardiac function in patients with multi-vessel disease (MVD). Patients with MVD are defined as having at least one additional major vessel exhibiting no less than 75% stenosis combined with the presence of a CTO artery.
METHODS AND RESULTS
Patients will be prospectively recruited who meet the following criteria:Patients presenting with no necrosis of myocardial tissue in the territory of the CTO will be excluded. Recruited patients will be randomized into 2 groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group). The primary outcome will be the change in cardiac function evaluated via CMR at a 12-month of follow-up appointment, which will be compared to a baseline measurement. Secondary outcomes include occurrence of major cardiac events, CMR-assessed myocardial viability in the CTO-supplied territory, and quality of life assessed by Seattle angina questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7 after 12-month follow-up.
CONCLUSION
The SOS-moral trial will provide data necessary to determine whether to open concurrent CTOs among MVD patients with CMR-detected necrotic myocardial tissue.",2020,"Recruited patients will be randomized into 2 groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group).","['patients with multi-vessel disease (MVD', 'Patients will be prospectively recruited who meet the following criteria:Patients presenting with no necrosis of myocardial tissue in the territory of the CTO will be excluded', 'patients with multi-vessel disease (SOS-moral', 'MVD patients with CMR-detected necrotic myocardial tissue']","['percutaneous coronary interventions (PCIs', 'PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group', 'opening co-existing chronic total occlusions (CTOs']","['change in cardiac function evaluated via CMR', 'cardiac function', 'occurrence of major cardiac events, CMR-assessed myocardial viability in the CTO-supplied territory, and quality of life assessed by Seattle angina questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4225412', 'cui_str': 'Spondylo-ocular syndrome'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0442726', 'cui_str': 'Detected'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0643313,"Recruited patients will be randomized into 2 groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group).","[{'ForeName': 'Jinfan', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Zuo', 'Affiliation': 'Department of Community Health Research.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Beijing Anzhen Hospital.'}, {'ForeName': 'Mingduo', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Dongfeng', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Radiology, Beijing Friendship Hospital.'}, {'ForeName': 'Hongzhi', 'Initials': 'H', 'LastName': 'Mi', 'Affiliation': 'Department of Nuclear Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing.'}, {'ForeName': 'Xueyao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': 'Rongchong', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Dalian Medical University, Dalian.'}, {'ForeName': 'Xiantao', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020349']
3362,32481332,Standardization of rehabilitation program for post-apoplectic limb spasm treated by Tongjing Tiaoxing tuina and scalp acupuncture with physical therapy.,"BACKGROUND
Tong Jing Tiao Xing tuina (TJTX) is a Chinese massage method. Excising with scalp acupuncture (ESA) is a treatment combining scalp electroacupuncture with physical therapy (PT), and yinao fujian formula (YNFJ) is a Chinese oral herbal granule medicine. The combination of the 3 methods is called the ""Zhishen Tiaoxing"" (ZSTX) rehabilitation program, which is used as an alternative of limb spasm after stroke. There is little available evidence demonstrating its safety and efficacy.
METHODS
This will be a subject-blind, randomized controlled trial conducted in 3 medical centers. It will strictly follow the Standards for Reporting Interventions in Clinical Trials of Acupuncture, 2010. We will recruit 316 patients with limb spasm after stroke, 200 from the Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, China, 80 from the Second Affiliated Hospital of Heilongjiang University of Chinese medicine, Harbin, China, and 36 from Huashan Hospital of Fudan University, Shanghai, China. A block randomization sequence stratified by centers will be generated using SAS Version 9.2 software (SAS Institute, Cary, NC, USA), which was performed at the Guangdong Provincial Hospital of Chinese Medicine's Key Unit of Methodology in Clinical Research. The treatment group is treated with TJTX (once a day), ESA (once a day), and oral YNFJ (twice a day). The control group will be treated with PT. Two groups of patients will be treated 5 sessions a week for 4 weeks, and there will be 6-month follow-up. The outcome evaluators will be blinded to patient grouping. The primary outcome will be modified Ashworth scales. The secondary outcome indexes will be the simplified Fugl-Meyer assessment scale, surface electromyogram root mean square value, modified Barthel index, stroke-specific quality of life scale, health scale of traditional Chinese medicine, visual analogue scale (VAS), and the Hamilton depression scale.
DISCUSSION
The Randomized Controlled Trial (RCT) mainly aim to evaluate the effectiveness and safety of traditional Chinese medicine rehabilitation program, by comparing the treatment of ZSTX with the PT for the treatment of limb spasm after stroke.
TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR 1900024255. Registered on July 3, 2019.",2020,"The combination of the 3 methods is called the ""Zhishen Tiaoxing"" (ZSTX) rehabilitation program, which is used as an alternative of limb spasm after stroke.","['3 medical centers', 'limb spasm after stroke', '316 patients with limb spasm after stroke, 200 from the Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, China, 80 from the Second Affiliated Hospital of Heilongjiang University of Chinese medicine, Harbin, China, and 36 from Huashan Hospital of Fudan University, Shanghai, China']","['scalp electroacupuncture with physical therapy (PT), and yinao fujian formula (YNFJ', 'PT', 'scalp acupuncture (ESA', 'oral YNFJ', 'Tongjing Tiaoxing tuina and scalp acupuncture with physical therapy', 'ZSTX', 'TJTX', 'ESA', 'Tong Jing Tiao Xing tuina (TJTX', 'traditional Chinese medicine rehabilitation program']","['simplified Fugl-Meyer assessment scale, surface electromyogram root mean square value, modified Barthel index, stroke-specific quality of life scale, health scale of traditional Chinese medicine, visual analogue scale (VAS), and the Hamilton depression scale', 'modified Ashworth scales']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0183964', 'cui_str': 'Tong'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}]",316.0,0.0846612,"The combination of the 3 methods is called the ""Zhishen Tiaoxing"" (ZSTX) rehabilitation program, which is used as an alternative of limb spasm after stroke.","[{'ForeName': 'Qiongshuai', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Tuina, Changchun University of Chinese Medicine.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Tuina, Traditional Chinese Medicine Hospital of Jilin Province.'}, {'ForeName': 'Guangcheng', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': 'Department of Rehabilitation, The Third Affiliated Hospital of Changchun University of Chinese Medicine, Changchun.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'Department of Acupuncture, The 1st affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.'}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Tuina, Changchun University of Chinese Medicine.'}, {'ForeName': 'Deyu', 'Initials': 'D', 'LastName': 'Cong', 'Affiliation': 'Department of Tuina, Traditional Chinese Medicine Hospital of Jilin Province.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Tuina, Changchun University of Chinese Medicine.'}, {'ForeName': 'Bailin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'Department of Acupuncture and Tuina, Changchun University of Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020368']
3363,32481334,Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial.,"BACKGROUND
Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim of the present pilot study is to assess the preliminary effects of fire needle therapy on mild-moderate BPH.
METHODS
The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment.
DISCUSSION
The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies.",2020,"The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device.","['mild-moderate benign prostatic hyperplasia', 'Benign prostatic hyperplasia (BPH', '60 eligible participants', 'mild-moderate BPH', 'middle-aged and elderly males']","['fire needle therapy', 'fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH', 'Fire needle therapy']","['change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device', 'change in the International Prostate Symptom Score', 'safety and tolerability']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1276791', 'cui_str': 'Education assistance'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1302166', 'cui_str': 'B mode ultrasound'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.0994786,"The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Yun-Qing', 'Initials': 'YQ', 'LastName': 'Xun', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Gui-Ling', 'Initials': 'GL', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Lin-Peng', 'Initials': 'LP', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Lian-Cheng', 'Initials': 'LC', 'LastName': 'Jia', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Wei-Guang', 'Initials': 'WG', 'LastName': 'Li', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Xue-Mei', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': 'Ultrasound Diagnostics Division, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hui-Lin', 'Initials': 'HL', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}, {'ForeName': 'Jing-Qing', 'Initials': 'JQ', 'LastName': 'Sun', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation.'}]",Medicine,['10.1097/MD.0000000000020376']
3364,32481345,Isokinetic back training is more effective than core stabilization training on pain intensity and sports performances in football players with chronic low back pain: A randomized controlled trial.,"BACKGROUND
Isokinetic training (IKT) and core stabilization training (CST) are commonly used for balance training in musculoskeletal conditions. The knowledge about the effective implementation of these training protocols on sports performances in university football players with chronic low back pain (LBP) is lacking.
OBJECTIVE
To find and compare the effects of IKT and CST on sports performances in university football players with chronic LBP.
DESIGN
Randomized, double-blinded controlled study.
SETTING
University hospital.
PARTICIPANTS
Sixty LBP participants divided into isokinetic group (IKT; n = 20), core stabilization group (CST; n = 20), and the control group (n = 20) and received respected exercises for 4 weeks.
OUTCOME MEASURES
Clinical (pain intensity and player wellness) and sports performances (40 m sprint, 4 × 5 m sprint, submaximal shuttle running, counter movement jump, and squat jump) scores were measured at baseline, after 4 weeks, 8 weeks, and 3 months.
RESULTS
Four weeks following training IKT group shows more significant changes in pain intensity and player wellness scores than CST and control groups (P ≤ .001). Sports performance variables (40 m sprint, 4 × 5 m sprint, submaximal shuttle running, counter movement jump and squat jump) scores also show significant improvement in IKT group than the other 2 groups (P ≤ .001).
CONCLUSION
This study suggests that training through IKT improves pain intensity and sports performances than CST in university football players with chronic LBP.",2020,Four weeks following training IKT group shows more significant changes in pain intensity and player wellness scores than CST and control groups (P ≤ .001).,"['university football players with chronic low back pain (LBP', 'Sixty LBP participants divided into', 'football players with chronic low back pain', 'university football players with chronic LBP', 'University hospital']","['IKT and CST', 'core stabilization training', 'IKT', 'Isokinetic back training', 'Isokinetic training (IKT) and core stabilization training (CST', 'isokinetic group (IKT; n\u200a=\u200a20), core stabilization group (CST; n\u200a=\u200a20), and the control group (n\u200a=\u200a20) and received respected exercises for 4 weeks']","['Clinical (pain intensity and player wellness) and sports performances (40 m sprint, 4 × 5 m sprint, submaximal shuttle running, counter movement jump, and squat jump) scores', 'submaximal shuttle running, counter movement jump and squat jump) scores', 'pain intensity and sports performances', 'pain intensity and player wellness scores']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.126822,Four weeks following training IKT group shows more significant changes in pain intensity and player wellness scores than CST and control groups (P ≤ .001).,"[{'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Bader A', 'Initials': 'BA', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abodonya', 'Affiliation': 'Anesthesia and Intensive Care Department, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ayman K', 'Initials': 'AK', 'LastName': 'Saleh', 'Affiliation': 'College of Medicine, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}]",Medicine,['10.1097/MD.0000000000020418']
3365,32486864,Robot-assisted Laparoscopic Partial Nephrectomy in Selective Ischemia versus Conventional Laparoscopic Partial Nephrectomy in Total Ischemia: Functional and Surgical Outcomes of a Prospective Single Surgeon Randomised Study.,"Background Laparoscopic partial nephrectomy (LPN) and robot-assisted partial nephrectomy (RAPN) are commonly used techniques for treating small renal masses. Regarding renal function (RF) preservation, no superiority of one technique over the other has yet been definitely demonstrated. Objective To compare functional and surgical outcomes of LPN and RAPN. Patients/Methods Between 2015 and 2019, we prospectively randomized 115 patients with cT1-T2 renal masses to LPN in total ischemia or RAPN in selective ischemia. Primary endpoint was RF preservation, assessed by renal scintigraphy (RS). RS assessments were performed preoperatively and at 6 months follow-up. Secondary endpoints included clinical, histopathological and surgical outcomes. Results 108 patients were included in the final analysis. Patient and tumor characteristics were comparable. No significant difference in RS values after 6 months was observed between both groups. Median (IQR) RF change after 6 months was -18.0% (-26.5 to -11.0) in LPN group and -20.0 (-33.2 to -12.0) in RAPN group (p=0.3). Mean (SD) warm ischemia time was 21.1 (6.1) min in LPN group and 19.6 (7.7) min in RAPN group (p=0.2). No positive surgical margins (PSM) occurred in the LPN group, while RAPN group had PSM in 4.9% (n=3); p=0.099. Renal volume loss after 6 months was 27.5% (22.7 to 45.7) in the LPN group versus 37.5 (13.7 to 54.2) in the RAPN group (p=0.5). Mean operative times were lower in the LPN group (192.3 min (SD 44.5) versus 230.2 min (SD 59.6), p=0.001). More complications occurred in the LPN group (31% versus 21%, p=0.075). Transfusion rates were 15% for LPN and 11% for RAPN. Conclusions In terms of preserving renal function, LPN in total ischemia and RAPN in selective ischemia are comparable. In most patients, RF decrease of the affected kidney after PN seems to not exceed 25%, regardless of the surgical approach.",2020,"Mean operative times were lower in the LPN group (192.3 min (SD 44.5) versus 230.2 min (SD 59.6), p=0.001).","['115 patients with cT1-T2 renal masses to LPN in total ischemia or RAPN in selective ischemia', 'Total Ischemia', '108 patients were included in the final analysis', 'Patients/Methods Between 2015 and 2019']","['RAPN', 'LPN', ' Laparoscopic partial nephrectomy (LPN) and robot-assisted partial nephrectomy (RAPN', 'Conventional Laparoscopic Partial Nephrectomy', 'Robot-assisted Laparoscopic Partial Nephrectomy', 'LPN and RAPN']","['Mean (SD) warm ischemia time', 'More complications', 'Median (IQR) RF change', 'positive surgical margins (PSM', 'Renal volume loss', 'Mean operative times', 'RF preservation, assessed by renal scintigraphy (RS', 'clinical, histopathological and surgical outcomes', 'Transfusion rates', 'RS values']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C4039858', 'cui_str': 'Robot assisted laparoscopic partial nephrectomy'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C4039858', 'cui_str': 'Robot assisted laparoscopic partial nephrectomy'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1563923', 'cui_str': 'Warm Ischemic Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C1310550', 'cui_str': 'Pteroylpoly-gamma-glutamate carboxypeptidase'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",115.0,0.0746323,"Mean operative times were lower in the LPN group (192.3 min (SD 44.5) versus 230.2 min (SD 59.6), p=0.001).","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Würnschimmel', 'Affiliation': 'Luzerner Kantonsspital, 30748, Klinik für Urologie, Luzern, Luzern, Switzerland; c.wuernschimmel@gmail.com.'}, {'ForeName': 'Giovanni Battista', 'Initials': 'GB', 'LastName': 'Di Pierro', 'Affiliation': 'Luzerner Kantonsspital, 30748, Klinik für Urologie, Luzern, Luzern, Switzerland; gb.dipierro@libero.it.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moschini', 'Affiliation': 'Luzerner Kantonsspital, 30748, Klinik für Urologie, Luzern, Switzerland; marco.moschini87@gmail.com.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Grande', 'Affiliation': 'Luzerner Kantonsspital, 30748, Klinik für Urologie, Luzern, Luzern, Switzerland; grandepietro@gmail.com.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Baumeister', 'Affiliation': 'Luzerner Kantonsspital, 30748, Klinik für Urologie, Luzern, Luzern, Switzerland; philipp.baumeister@luks.ch.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Roth', 'Affiliation': 'Luzerner Kantonsspital, 30748, Klinik für Radiologie, Luzern, Luzern, Switzerland; m.roth@rimed.ch.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Mordasini', 'Affiliation': 'Luzerner Kantonsspital, 30748, Klinik für Urologie, Luzern, Luzern, Switzerland; livio.mordasini@luks.ch.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Mattei', 'Affiliation': 'Luzerner Kantonsspital, 30748, Klinik für Urologie, Luzern, Switzerland; agostino.mattei@luks.ch.'}]",Journal of endourology,['10.1089/end.2020.0143']
3366,32486934,Rituximab use as induction therapy for lupus nephritis: a systematic review.,"OBJECTIVE
Rituximab (RTX) has important usage in rheumatoid arthritis and vasculitis. There remains a need for more, better, and safer treatments for patients with lupus nephritis (LN). RTX has been trialed in such patients without definitive conclusions about its effectiveness. As a role for RTX has not been clearly established for LN, we carried out a systematic review and analysis.
METHODS
We identified 31 studies of RTX for class I-VI LN, and assessed complete renal response (CRR) and partial renal response (PRR) using criteria including serum creatinine, proteinuria, and urinary sediment. Due to differences in the pediatric presentation of the disease, studies focusing on pediatric patients were excluded.
RESULTS
One randomized controlled trial (RCT) showed superiority of RTX+cyclophosphamide (CYC) versus CYC alone (64% vs. 21% CRR and 19% vs. 36% PRR). Six prospective and retrospective studies utilizing RTX monotherapy found 66% CRR or PRR in all patients. Eleven studies that investigated RTX in combination with CYC or mycophenolate mofetil (MMF) also found 66% CRR or PRR in all patients. In total, the CRR for Caucasian, East Asian, and Hispanic patients were 77%, 38%, and 28%, respectively.
CONCLUSIONS
RTX appeared to benefit certain LN patients, but most studies were not randomized or properly controlled, were heterogeneous in design, subjects, and LN types, and were not comparable, and must therefore be interpreted cautiously. RTX alone may not deplete B cells sufficiently for the perturbations of LN. In addition, RTX may induce responses differently among patients of different ethnic and racial backgrounds. Furthermore, there were wide variations in the baseline characteristics of the patients, namely LN class, time course of disease, age, and prior immunosuppressive use. We suggest a prospective RCT in patients aged 18-65 years with class IV LN. Ideally, the patients would not have received prior immunosuppression and would better represent different ethnicities. The treatment groups would be RTX, RTX+belimumab, CYC, and MMF groups, with pulse-dose steroids during induction followed by maintenance steroids and MMF. The CRR and PRR would be assessed at 12 and 24 months. This or a similar study might clarify RTX's role in the treatment of LN.",2020,One randomized controlled trial (RCT) showed superiority of RTX+cyclophosphamide (CYC) versus CYC alone (64% vs. 21% CRR and 19% vs. 36% PRR).,"['patients with lupus nephritis (LN', 'lupus nephritis', 'patients aged 18-65 years with class IV LN']","['Rituximab (RTX', 'Rituximab', 'mycophenolate mofetil (MMF', 'RTX', 'RTX, RTX+belimumab, CYC, and MMF groups, with pulse-dose steroids', 'RTX monotherapy', 'RTX+cyclophosphamide (CYC) versus CYC']","['complete renal response (CRR) and partial renal response (PRR) using criteria including serum creatinine, proteinuria, and urinary sediment', 'CRR and PRR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C1261248', 'cui_str': 'Urine sediment'}]",,0.0609728,One randomized controlled trial (RCT) showed superiority of RTX+cyclophosphamide (CYC) versus CYC alone (64% vs. 21% CRR and 19% vs. 36% PRR).,"[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Stolyar', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lahita', 'Affiliation': ""Department of Medicine, St. Joseph's Regional Medical Centre, Paterson, USA.""}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Panush', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}]",Lupus,['10.1177/0961203320928412']
3367,32487024,The effect of a dementia awareness class on changing dementia attitudes in adolescents.,"BACKGROUND
Current evidence suggests that negative and stigmatising attitudes towards dementia may develop at a young age. There are a number of dementia education and awareness initiatives aimed at reducing stigma, though they have not been robustly evaluated to establish the impact on dementia attitudes or suitability in adolescent populations. This study explored the efficacy and satisfaction of one such initiative (Dementia Friends) in a British adolescent sample.
METHODS
301 adolescents (M = 12.6 years old, SD = 0.73) were assigned to either receive Dementia Friends (a 60-min interactive class that teaches about dementia and its effects on people's lives) or education as usual. All participants completed a series of validated questionnaires pre- and post-intervention, related to dementia attitudes (Brief A-ADS and KIDS).
RESULTS
Adolescents in the dementia awareness group showed little to no improvements between time-points. The change scores in the dementia awareness group did not significantly differ to the control group based on both KIDS (d = - 0.003, p = 0.98) and Brief A-ADS (d = 0.14, p = 0.13) measures. There was no Group x Time effect after controlling for confounding variables.
CONCLUSIONS
Dementia Friends is successful in terms of reach and impact, though this study suggests that it may fall short of achieving its goal of improving attitudes towards dementia. Importantly, Dementia Friends did not have a negative effect on attitudes, and the majority of adolescents enjoyed the sessions. It is important that these findings are replicated in a larger randomised-controlled study.",2020,"The change scores in the dementia awareness group did not significantly differ to the control group based on both KIDS (d = - 0.003, p = 0.98) and Brief A-ADS (d = 0.14, p = 0.13) measures.","['301 adolescents (M\u2009=\u200912.6\u2009years old, SD\u2009=\u20090.73', 'adolescents', 'British adolescent sample']","['dementia awareness class', 'Dementia Friends']",['dementia attitudes (Brief A-ADS and KIDS'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",301.0,0.0324211,"The change scores in the dementia awareness group did not significantly differ to the control group based on both KIDS (d = - 0.003, p = 0.98) and Brief A-ADS (d = 0.14, p = 0.13) measures.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Farina', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9RY, UK. N.farina@bsms.ac.uk.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hughes', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9RY, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Brighton and Hove Dementia Action Alliance, Brighton, UK.'}, {'ForeName': 'Sahdia', 'Initials': 'S', 'LastName': 'Parveen', 'Affiliation': 'Centre for Applied Dementia Studies, University of Bradford, Bradford, UK.'}, {'ForeName': 'Alys W', 'Initials': 'AW', 'LastName': 'Griffiths', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Galvin', 'Affiliation': 'School of Health Sciences, University of Brighton, Brighton, UK.'}, {'ForeName': 'Sube', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Faculty of Health, University of Plymouth, Plymouth, UK.'}]",BMC geriatrics,['10.1186/s12877-020-01589-6']
3368,32487033,A convenient clinical nomogram for predicting the cancer-specific survival of individual patients with small-intestine adenocarcinoma.,"BACKGROUND
The objective of this study was to develop a practical nomogram for predicting the cancer-specific survival (CSS) of patients with small-intestine adenocarcinoma.
METHODS
Patients diagnosed with small-intestine adenocarcinoma between 2010 and 2015 were selected for inclusion in this study from the Surveillance, Epidemiology, and End Results (SEER) database. The selected patients were randomly divided into the training and validation cohorts at a ratio of 7:3. The predictors of CSS were identified by applying both forward and backward stepwise selection methods in a Cox regression model. The performance of the nomogram was measured by the concordance index (C-index), the area under receiver operating characteristic curve (AUC), calibration plots, the net reclassification improvement (NRI), the integrated discrimination improvement (IDI), and decision-curve analysis (DCA).
RESULTS
Multivariate Cox regression indicated that factors including age at diagnosis, sex, marital status, insurance status, histology grade, SEER stage, surgery status, T stage, and N stage were independent covariates associated with CSS. These factors were used to construct a predictive model, which was built and virtualized by a nomogram. The C-index of the constructed nomogram was 0.850. The AUC values indicated that the established nomogram displayed better discrimination performance than did the seventh edition of the American Joint Committee on Cancer TNM staging system in predicting CSS. The IDI and NRI also showed that the nomogram exhibited superior performance in both the training and validation cohorts. Furthermore, the calibrated nomogram predicted survival rates that closely corresponded to actual survival rates, while the DCA demonstrated the considerable clinical usefulness of the nomogram.
CONCLUSION
We have constructed a nomogram for predicting the CSS of small-intestine adenocarcinoma patients. This prognostic model may improve the ability of clinicians to predict survival in individual patients and provide them with treatment recommendations.",2020,The AUC values indicated that the established nomogram displayed better discrimination performance than did the seventh edition of the American Joint Committee on Cancer TNM staging system in predicting CSS.,"['Patients diagnosed with small-intestine adenocarcinoma between 2010 and 2015 were selected for inclusion in this study from the Surveillance, Epidemiology, and End Results (SEER) database', 'patients with small-intestine adenocarcinoma', 'small-intestine adenocarcinoma patients', 'individual patients with small-intestine adenocarcinoma']",[],"['survival rates', 'cancer-specific survival (CSS', 'concordance index (C-index), the area under receiver operating characteristic curve (AUC), calibration plots, the net reclassification improvement (NRI), the integrated discrimination improvement (IDI), and decision-curve analysis (DCA', 'actual survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0278803', 'cui_str': 'Adenocarcinoma of small intestine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0276047,The AUC values indicated that the established nomogram displayed better discrimination performance than did the seventh edition of the American Joint Committee on Cancer TNM staging system in predicting CSS.,"[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Hairong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""Clinical Research Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'School of Nursing and Health, Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'School of Nursing and Health, Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Xuequn', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Center for Evidence-Based Medicine and Clinical Research, Huaihe Hospital of Henan University, Kaifeng, Henan, China. hhyyrxq@126.com.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China. victor7922@163.com.'}]",BMC cancer,['10.1186/s12885-020-06971-6']
3369,32487035,Ipilimumab or FOLFOX with Nivolumab and Trastuzumab in previously untreated HER2-positive locally advanced or metastatic EsophagoGastric Adenocarcinoma - the randomized phase 2 INTEGA trial (AIO STO 0217).,"BACKGROUND
Esophagogastric adenocarcinoma (EGA) currently represents a main cause of cancer related death. Despite an intensified treatment for locally advanced or metastatic EGA with a doublet chemotherapy consisting of a platinum compound and a fluoropyrimidine in combination with trastuzumab for HER2-positive disease or in selected cases with docetaxel, survival remains poor. Recently, immune-oncology based strategies relevantly improved the treatment of different solid tumors and showed some promise in late or later stage trials in EGA. Notably, the combination of immunotherapy with trastuzumab to enhance anti-tumor immunity through activation of innate and adaptive immunity was beneficial in preclinical studies or clinical studies in breast cancer.
METHODS
The INTEGA study is an open-label, randomized, multicenter, exploratory phase II trial designed to assess clinical performance, safety and tolerability of ipilimumab or 5-FU/folinic acid and oxaliplatin (FOLFOX) in combination with nivolumab and trastuzumab in patients with previously untreated HER2-positive, locally advanced or metastatic EGA. The primary objective is to determine the clinical performance of ipilimumab or FOLFOX in combination with nivolumab and trastuzumab in terms of overall survival. Secondary objectives are safety and tolerability, efficacy in terms of progression-free survival and objective response rate and blood-based signatures (e.g. immune response or suppression of anti-HER2 resistance) that may correlate with treatment response.
DISCUSSION
Recent evidence from the phase II NCT02954536 study (oxaliplatin, capecitabine, trastuzumab and pembrolizumab) suggests the clinical feasibility of combining chemotherapy, trastuzumab and checkpoint inhibition in EGA. However, evidence for a chemotherapy-free regimen is also mounting in HER2-positive disease (NCT02689284) i.e. margetuximab and Pembrolizumab. Both studies excelled with high overall response rates and manageable toxicities. The INTEGA study aims to comparatively assess these results and select a promising new 1st line regimen which then needs to be confirmed in a randomized phase III trial. Further, the translational part of the study might help to better stratify patients and tailor treatment of either arm.
TRIAL REGISTRATION
NCT03409848 24.01.2018.",2020,"Recently, immune-oncology based strategies relevantly improved the treatment of different solid tumors and showed some promise in late or later stage trials in EGA.","['Esophagogastric adenocarcinoma (EGA', 'previously untreated HER2-positive locally advanced or metastatic EsophagoGastric Adenocarcinoma', 'patients with previously untreated HER2-positive, locally advanced or metastatic EGA']","['nivolumab and trastuzumab', 'Ipilimumab or FOLFOX with Nivolumab and Trastuzumab', 'immunotherapy with trastuzumab', 'fluoropyrimidine in combination with trastuzumab', 'oxaliplatin, capecitabine, trastuzumab and pembrolizumab', 'ipilimumab or FOLFOX', 'ipilimumab or 5-FU/folinic acid and oxaliplatin (FOLFOX']","['clinical performance, safety and tolerability', 'manageable toxicities', 'safety and tolerability, efficacy in terms of progression-free survival and objective response rate and blood-based signatures (e.g. immune response or suppression of anti-HER2 resistance', 'overall survival']","[{'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0682981,"Recently, immune-oncology based strategies relevantly improved the treatment of different solid tumors and showed some promise in late or later stage trials in EGA.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tintelnot', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Eray', 'Initials': 'E', 'LastName': 'Goekkurt', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': 'Binder', 'Affiliation': 'University Hospital Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Charité, University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lorenzen', 'Affiliation': 'Rechts der Isar Hospital, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jorge Riera', 'Initials': 'JR', 'LastName': 'Knorrenschild', 'Affiliation': 'University Hospital of Giessen and Marburg, Marburg, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Kretzschmar', 'Affiliation': 'MVZ Mitte, Practice for Hematology and Oncology, Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ettrich', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Lindig', 'Affiliation': 'University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Jacobasch', 'Affiliation': 'Practice of Hematology and Oncology, Dresden, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pink', 'Affiliation': 'Helios Clinic Bad Saarow, Bad Saarow, Germany and University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Krankenhaus Nordwest, UCT University Cancer Center, Frankfurt, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hinke', 'Affiliation': 'CCRC, Düsseldorf, Germany.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Hegewisch-Becker', 'Affiliation': 'Hematology-Oncology Practice Hamburg (HOPE), Hamburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Nilsson', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany. a.stein@uke.de.'}]",BMC cancer,['10.1186/s12885-020-06958-3']
3370,32487038,A phase II randomized trial of RAdium-223 dichloride and SABR Versus SABR for oligomEtastatic prostate caNcerS (RAVENS).,"BACKGROUND
Metastasis directed therapy (MDT) for patients with oligometastatic disease is associated with improvements in progression free survival (PFS) and overall survival (OS) compared to systemic therapy alone. Additionally, within a prostate-cancer-specific cohort, MDT is able to forestall initiation of androgen deprivation therapy (ADT) in men with hormone-sensitive, oligometastatic prostate cancer (HSOPCa) compared to observation. While MDT appears to be safe and effective in HSOPCa, a large percentage of men will eventually have disease recurrence. Patterns of failure in HSOPCa demonstrate patients tend to have recurrence in the bone following MDT, raising the question of sub-clinically-apparent osseous disease. Radium-223 dichloride is a radiopharmaceutical with structural similarity to calcium, allowing it to be taken up by bone where it emits alpha particles, and therefore might have utility in the treatment of micrometastatic osseous disease. Therefore, the primary goal of the phase II RAVENS trial is to evaluate the efficacy of MDT + radium-223 dichloride in prolonging progression free survival in men with HSOPCa.
METHODS
Patients with HSOPCa and 3 or less metastases with at least 1 bone metastasis will be randomized 1:1 to stereotactic ablative radiation (SABR, also known as stereotactic body radiation therapy (SBRT)) alone vs SABR + radium-223 dichloride with a minimization algorithm to balance assignment by institution, primary intervention, prior hormonal therapy, and PSA doubling time. SABR is delivered in one to five fractions and patients in the SABR + radium-223 dichloride arm will receive six infusions of radium-223 dichloride at four-week intervals. The primary end point is progression free survival. The secondary clinical endpoints include toxicity and quality of life assessments, local control at 12 months, locoregional progression, time to distant progression, time to new metastasis, and duration of response.
DISCUSSION
The RAVENS trial will be the first described phase II, non-blinded, randomized study to compare SABR +/- radium-223 dichloride in patients with HSOPCa and 3 or less metastases with at least one bone metastasis. The primary hypothesis is that SABR + radium-223 dichloride will increase median progression-free survival from 10 months in the SABR arm to 20 months in the SABR + radium-223 dichloride arm.
TRIAL REGISTRATIONS
Clinicaltrials.gov. Identifier: NCT04037358. Date of Registration: July 30, 2019. Date of First Participant Enrolled: August 9, 2019. Date of Last Approved Amendment: October 16, 2019. Protocol Version: Version 5.",2020,"The secondary clinical endpoints include toxicity and quality of life assessments, local control at 12 months, locoregional progression, time to distant progression, time to new metastasis, and duration of response.
","['men with HSOPCa', 'patients with oligometastatic disease', 'Patients with HSOPCa and 3 or less metastases with at least 1 bone metastasis', 'patients with HSOPCa and 3 or less metastases with at least one bone metastasis', 'men with hormone-sensitive, oligometastatic prostate cancer (HSOPCa']","['stereotactic ablative radiation (SABR, also known as stereotactic body radiation therapy (SBRT)) alone vs SABR + radium-223 dichloride with a minimization algorithm to balance assignment by institution, primary intervention, prior hormonal therapy, and PSA doubling time', 'RAdium-223 dichloride and SABR Versus SABR', 'Metastasis directed therapy (MDT', 'androgen deprivation therapy (ADT']","['progression free survival', 'toxicity and quality of life assessments, local control at 12\u2009months, locoregional progression, time to distant progression, time to new metastasis, and duration of response', 'progression free survival (PFS) and overall survival (OS', 'median progression-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3541342', 'cui_str': 'RADIUM CHLORIDE RA-223'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0554777,"The secondary clinical endpoints include toxicity and quality of life assessments, local control at 12 months, locoregional progression, time to distant progression, time to new metastasis, and duration of response.
","[{'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Hasan', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Deek', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Hobbs', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Malek', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Noura', 'Initials': 'N', 'LastName': 'Radwan', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Kiess', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Shirl', 'Initials': 'S', 'LastName': 'Dipasquale', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Caldwell', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leitzel', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Wendler', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thompson', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Dudley', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Curtiland', 'Initials': 'C', 'LastName': 'Deville', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Greco', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Daniel Y', 'Initials': 'DY', 'LastName': 'Song', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Theodore L', 'Initials': 'TL', 'LastName': 'DeWeese', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gorin', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Denmeade', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Markowski', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Pomper', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Pienta', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Channing J', 'Initials': 'CJ', 'LastName': 'Paller', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA. tranp@jhmi.edu.'}]",BMC cancer,['10.1186/s12885-020-07000-2']
3371,32487065,Effects of an mHealth voice message service (mMitra) on maternal health knowledge and practices of low-income women in India: findings from a pseudo-randomized controlled trial.,"BACKGROUND
Mobile Health (mHealth) is becoming an important tool to improve health outcomes in maternal, newborn and child health (MNCH). Studies of mHealth interventions, have demonstrated their effectiveness in improving uptake of recommended maternal services such as antenatal visits. However, evidence of impact on maternal health outcomes is still limited.
METHODS
A pseudo-randomized controlled trial (single blind) was conducted to assess the impact of a voice-message based maternal intervention on maternal health knowledge, attitudes, practices and outcomes over time: Pregnancy (baseline/Time 1); Post-partum (Time 2) and when the infant turned one year old (Time 3). Women assigned to the mMitra intervention arm received gestational age- and stage-based educational voice messages via mobile phone in Hindi and Marathi, while those assigned to the control group did not. Both groups received standard care.
RESULTS
Two thousand sixteen women were enrolled. Interviews were conducted with 1516 women in the intervention group and 500 women in the control group at baseline and post-partum. The intervention group performed significantly better than controls on four maternal health practice indicators: receiving the tetanus toxoid injection (OR: 1.6, 95% Confidence Interval (CI): 1.05-2.4, p = 0.028), consulting a doctor if spotting or bleeding (OR: 1.72, 95%CI: 1.07-2.75, p = 0.025), saving money for delivery expenses (OR: 1.79, 95%CI: 1.38-2.33, p = 0.0001), and delivering in hospital (OR: 2.5, 95%CI: 1.49-4.35, p = 0.001). The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027). Both groups' knowledge improved from Time 1 to Time 2. Only one knowledge indicator, on seeking medical care during pregnancy, was statistically increased in the intervention group compared to controls. Anemia status at or near the time of delivery was unable to be assessed due to missing data from maternal health cards.
CONCLUSIONS
This study provides evidence that in low-resource settings, mobile voice messages providing tailored and timed information about pregnancy can positively impact maternal health care practices proven to improve maternal health outcomes. Additional research is needed to assess whether voice messaging can motivate behavior change better than text messaging, particularly in low literacy settings.
TRIAL REGISTRATION
The mMitra impact evaluation is registered with ISRCTN under Registration # 88968111, assigned on 6 September 2018 (See https://www.isrctn.com/ISRCTN88968111).",2020,"The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027).","['low-income women in India', '1516 women in the intervention group and 500 women in the control group at baseline and post-partum', 'Two thousand sixteen women were enrolled']","['mMitra intervention arm received gestational age- and stage-based educational voice messages via mobile phone in Hindi and Marathi', 'standard care', 'mHealth voice message service (mMitra', 'tetanus toxoid injection', 'voice-message based maternal intervention']","['consulting a doctor if spotting or bleeding', 'maternal health knowledge and practices', 'maternal health knowledge, attitudes, practices and outcomes over time', 'maternal health outcomes', 'saving money for delivery expenses', 'Anemia status']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0019547', 'cui_str': 'Hindi language'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",2016.0,0.207524,"The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027).","[{'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Murthy', 'Affiliation': 'Foundation for Research in Health Systems, #G-1, Brigade Business Suites, 10th Main, Jayanagar 2nd Block, Bengaluru, 560011, India.'}, {'ForeName': 'Subhashini', 'Initials': 'S', 'LastName': 'Chandrasekharan', 'Affiliation': 'HealthEnabled, Unit D11 Westlake Square, Westlake Drive, Westlake, Cape Town, 7945, South Africa.'}, {'ForeName': 'Muthu Perumal', 'Initials': 'MP', 'LastName': 'Prakash', 'Affiliation': 'Foundation for Research in Health Systems, G2, 5/26 Pillayar Kovil Street, Medavakkam, Chennai, 600100, India.'}, {'ForeName': 'Aakash', 'Initials': 'A', 'LastName': 'Ganju', 'Affiliation': 'Saat Health, 1103, Glencroft, Hiranandani Gardens, Powai, Mumbai, 400076, India.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Peter', 'Affiliation': 'Johnson & Johnson, 241 Main Road, Retreat, Cape Town, 7945, South Africa.'}, {'ForeName': 'Nadi', 'Initials': 'N', 'LastName': 'Kaonga', 'Affiliation': 'HealthEnabled, Unit D11 Westlake Square, Westlake Drive, Westlake, Cape Town, 7945, South Africa.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Mechael', 'Affiliation': 'HealthEnabled, Unit D11 Westlake Square, Westlake Drive, Westlake, Cape Town, 7945, South Africa. pmechael@gmail.com.'}]",BMC public health,['10.1186/s12889-020-08965-2']
3372,32487077,Anodal transcranial direct current stimulation reduces motor slowing in athletes and non-athletes.,"BACKGROUND
Motor fatigability describes a phenomenon that occurs when exhaustive exercise or physically demanding tasks are executed over an extended period of time. Concerning fast repetitive movements, it is noticeable by a reduction in movement speed (motor slowing, MoSlo) and occurs due to both central and peripheral factors. The aim of the present study was to examine the presence of MoSlo during hand- (HTT) and foot-tapping tasks (FTT) comparing trained football (FB) and handball players (HB) and non-athletes (NA). Furthermore, we were interested in how far anodal transcranial direct current stimulation (tDCS) might be capable of modulating MoSlo as compared to sham.
METHODS
A total number of 46 participants were enrolled in a sham-controlled, double-blinded, cross-over study. HTT and FTT were performed before, during, after as well as 30 min after 20 min of tDCS over the leg area of the primary motor cortex (M1).
RESULTS
We could demonstrate that MoSlo during HTT and FTT is a general phenomenon that is observed independent of the type of sports and/or training status. Furthermore, we were able to show a tDCS-induced reduction in MoSlo specifically during FTT in both trained athletes and NA. No such effects could be observed for HTT, indicating local specificity of tDCS-induced effects on a behavioral level.
CONCLUSION
We could demonstrate that tDCS is capable of reducing motor fatigability during fast repetitive movements. These findings are of pivotal interest for many sports where fatigability resistance is a limiting factor in maintaining repetitive movement patterns.",2020,"No such effects could be observed for HTT, indicating local specificity of tDCS-induced effects on a behavioral level.
","['A total number of 46 participants', 'athletes and non-athletes']","['MoSlo during hand- (HTT) and foot-tapping tasks (FTT) comparing trained football (FB) and handball players (HB) and non-athletes (NA', 'anodal transcranial direct current stimulation (tDCS', 'tDCS', 'Anodal transcranial direct current stimulation']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],46.0,0.0622472,"No such effects could be observed for HTT, indicating local specificity of tDCS-induced effects on a behavioral level.
","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Seidel-Marzi', 'Affiliation': 'Institute for General Kinesiology and Exercise Science, Faculty of Sport Science, University of Leipzig, Jahnallee 59, 04109, Leipzig, Germany. oliver.seidel@uni-leipzig.de.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ragert', 'Affiliation': 'Institute for General Kinesiology and Exercise Science, Faculty of Sport Science, University of Leipzig, Jahnallee 59, 04109, Leipzig, Germany.'}]",BMC neuroscience,['10.1186/s12868-020-00573-5']
3373,32481404,Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients (TJ116E).,"BACKGROUND
Patients with esophageal cancer suffer from anxiety in the perioperative period surrounding esophagectomy; this may increase the risk of postoperative complications. In particular, postoperative aspiration pneumonia carries a high risk of hospital mortality. Bukuryoingohangekobokuto (BRIHK) is a traditional Japanese medicine formula used to treat anxiety, the feeling of a foreign body in the esophagus, and water brash. We hypothesize that BRIHK might be effective for both anxiety and water brash in perioperative patients with esophageal cancer. The aim of this study is to evaluate the efficacy and safety of BRIHK compared to a placebo for anxiety and water brash in perioperative esophageal cancer patients.
METHOD/DESIGN
This will be a single-center, single blind, placebo-controlled randomized clinical trial. Twenty-four patients with esophageal cancer undergoing radical resection surgery will be registered to participate, then randomly and blindly assigned to the BRIHK treatment group or control group. Patients will be administered BRIHK or the placebo from 2 weeks before to 6 weeks after surgery. Primary outcome measures will be anxiety and depression (assessed using the Hospital Anxiety and Depression Scale), and water brash (assessed using the 10-item Eating Assessment Tool, Esophagus and Stomach Surgery Symptom Scale, and videofluoroscopy swallowing measurement). Incidences of aspiration pneumonia will be noted and abdominal gas volume, inflammatory markers, and nutrition status will be evaluated.
DISCUSSION
This investigative study will provide clinical evidence of BRIHK administration for anxiety and water brash, which might improve mental distress and reduce postoperative mortality.
TRIAL REGISTRATION
The protocol and progress are registered on the Japan Registry of Clinical Trials (jRCT s021190001) and University Hospital Medical Information Network (UMIN000031330). The protocol was approved by the Japanese Ministry of Health, Labour and Welfare certified clinical research review board, Tohoku University (CRB2180001).",2020,"Primary outcome measures will be anxiety and depression (assessed using the Hospital Anxiety and Depression Scale), and water brash (assessed using the 10-item Eating Assessment Tool, Esophagus and Stomach Surgery Symptom Scale, and videofluoroscopy swallowing measurement).","['Twenty-four patients with esophageal cancer undergoing', 'Patients with esophageal cancer suffer from anxiety in the perioperative period surrounding esophagectomy', 'perioperative esophageal cancer patients', 'perioperative patients with esophageal cancer', 'esophageal cancer patients (TJ116E']","['TJ-116 bukuryoingohangekobokuto', 'BRIHK treatment group or control group', 'Bukuryoingohangekobokuto (BRIHK', 'radical resection surgery', 'BRIHK', 'placebo']","['anxiety and depression (assessed using the Hospital Anxiety and Depression Scale), and water brash (assessed using the 10-item Eating Assessment Tool, Esophagus and Stomach Surgery Symptom Scale, and videofluoroscopy swallowing measurement', 'efficacy and safety']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0192398', 'cui_str': 'Operation on stomach'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0412099', 'cui_str': 'Videofluoroscopy swallow'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",24.0,0.102714,"Primary outcome measures will be anxiety and depression (assessed using the Hospital Anxiety and Depression Scale), and water brash (assessed using the 10-item Eating Assessment Tool, Esophagus and Stomach Surgery Symptom Scale, and videofluoroscopy swallowing measurement).","[{'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Arita', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takayama', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': 'Department of Surgery, Tohoku University Hospital.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Koseki', 'Affiliation': 'Department of Surgery, Tohoku University Hospital.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Taniyama', 'Affiliation': 'Department of Surgery, Tohoku University Hospital.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Ono', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kamei', 'Affiliation': 'Department of Surgery, Tohoku University Hospital.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Department of Kampo Medicine.'}]",Medicine,['10.1097/MD.0000000000020317']
3374,32481420,Removal of the root canal smear layer using Carisolv III and sodium hypochlorite.,"The present study investigated the effectiveness of a Carisolv III + 0.5% sodium hypochlorite (NaOCl)-based root canal irrigant for smear layer removal.Forty maxillary incisors were randomly divided into 4 groups (n = 10 per group). The canals in group A (experimental) were prepared with 0.5% NaOCl, and Carisolv III and 0.5% NaOCl was used for the final washing; groups B and C (positive controls) used 2% and 5.25% NaOCl, respectively; and group D (negative control) used phosphate-buffered saline (PBS). Ethylenediaminetetraacetic acid (EDTA) was used for all of the groups. A 5-point scoring scale and scanning electron microscopy were used to evaluate the effectiveness of the irrigants. The canals were consistently cleaner in the coronal and middle thirds than in the apical thirds (P < .05).For cleaning the root canals, 5.25% NaOCl was more effective than 2% NaOCl, 0.5% NaOCl + Carisolv III, and phosphate-buffered saline , respectively (P < .05). The 2% NaOCl solution showed similar results to 0.5% NaOCl + Carisolv III (P > .05). The combination of 5.25% NaOCl and 17% EDTA remains the most effective irrigant for removal of the root canal smear layer.A combination of Carisolv III + 0.5% NaOCl (with 17% EDTA) showed a cleaning ability similar to that of 2% NaOCl (with 17% EDTA).",2020,"The canals were consistently cleaner in the coronal and middle thirds than in the apical thirds (P < .05).For cleaning the root canals, 5.25% NaOCl was more effective than 2% NaOCl, 0.5% NaOCl + Carisolv III, and phosphate-buffered saline , respectively",['Forty maxillary incisors'],"['root canal smear layer using Carisolv III and sodium hypochlorite', 'phosphate-buffered saline (PBS', 'Carisolv III\u200a+\u200a0.5% NaOCl (with 17% EDTA', '0.5% NaOCl, and Carisolv III and 0.5% NaOCl', 'Carisolv III + 0.5% sodium hypochlorite (NaOCl)-based root canal irrigant', 'Ethylenediaminetetraacetic acid (EDTA']",[],"[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0769128', 'cui_str': 'Carisolv'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035846', 'cui_str': 'Root canal medicament'}]",[],,0.0203118,"The canals were consistently cleaner in the coronal and middle thirds than in the apical thirds (P < .05).For cleaning the root canals, 5.25% NaOCl was more effective than 2% NaOCl, 0.5% NaOCl + Carisolv III, and phosphate-buffered saline , respectively","[{'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Cariology and Endodontology, Qingdao Stomatological Hospital, Qingdao.'}, {'ForeName': 'Yong-Zhen', 'Initials': 'YZ', 'LastName': 'Ma', 'Affiliation': ""Department of Stomatology, Tai'an City Central Hospital, Tai'an.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ""Department of Stomatology, Tai'an City Central Hospital, Tai'an.""}, {'ForeName': 'Bing-Chang', 'Initials': 'BC', 'LastName': 'Xin', 'Affiliation': 'Department of Cariology and Endodontology, Qingdao Stomatological Hospital, Qingdao.'}, {'ForeName': 'Da-Shan', 'Initials': 'DS', 'LastName': 'Wang', 'Affiliation': 'Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'De-Gang', 'Initials': 'DG', 'LastName': 'Sun', 'Affiliation': 'Department of Cariology and Endodontology, Qingdao Stomatological Hospital, Qingdao.'}, {'ForeName': 'Ling-Xiang', 'Initials': 'LX', 'LastName': 'Wang', 'Affiliation': 'Department of Cariology and Endodontology, Qingdao Stomatological Hospital, Qingdao.'}]",Medicine,['10.1097/MD.0000000000020372']
3375,32481431,Simple resistance exercise decreases cytokeratin 18 and fibroblast growth factor 21 levels in patients with nonalcoholic fatty liver disease: A retrospective clinical study.,"Cytokeratin 18 (CK18) and fibroblast growth factor 21 (FGF21) are elevated in patients with nonalcoholic fatty liver disease (NAFLD) and are useful markers for identifying or monitoring outcomes. Exercise therapy is one of the established treatments for NAFLD; however, few studies have investigated the effectiveness of exercise therapy on CK18 and FGF21 levels. Therefore, the aim of the present study was to assess the effects of 12 weeks of simple resistance exercise on CK18 and FGF21 levels in patients with NAFLD.Fifty patients with NAFLD were assigned to a resistance exercise group (n = 23) or a control group (n = 27) for a trial period of 12 weeks. During the study, the resistance exercise group performed two exercises (push-ups and squats) three times a week on nonconsecutive days, whereas the control group proceeded with regular physical activities under a restricted diet. We then compared serum levels of CK18 fragments (M65) and FGF21 between groups just before and after the 12-week period.Serum M65 levels (880.0 ± 503.6 vs 648.9 ± 450.2 U/L; P < .01) were significantly decreased in the exercise group. However, no significant differences were observed in body mass index or skeletal muscle. The decreases in serum M65 (-231.1 ± 354.7 vs 56.2 ± 375.0 U/L; P = .02), and FGF21 levels (-41.7 ± 98.2 vs. 33.2 ± 127.6 pg/mL; P = .03) were significantly greater in the exercise than in the control group. Changes in M65 levels in the exercise group were significantly correlated with changes in alanine aminotransferase levels (r = 0.618, P < .01).Simple resistance exercise reduced CK18 and FGF21 levels in patients with NAFLD. These findings suggest that resistance exercise consisting of push-ups and squats helps prevent the progression of NAFLD.",2020,Cytokeratin 18 (CK18) and fibroblast growth factor 21 (FGF21) are elevated in patients with nonalcoholic fatty liver disease (NAFLD) and are useful markers for identifying or monitoring outcomes.,"['patients with NAFLD', 'patients with nonalcoholic fatty liver disease', 'patients with nonalcoholic fatty liver disease (NAFLD', 'patients with NAFLD.Fifty patients with NAFLD']","['Simple resistance exercise', 'Exercise therapy', 'simple resistance exercise', 'control group proceeded with regular physical activities under a restricted diet', 'resistance exercise']","['alanine aminotransferase levels', 'progression of NAFLD', 'body mass index or skeletal muscle', 'CK18 and FGF21 levels', 'serum M65', 'serum levels of CK18 fragments (M65) and FGF21', 'FGF21 levels', 'Serum M65 levels (880.0\u200a±', 'M65 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}]",,0.0205257,Cytokeratin 18 (CK18) and fibroblast growth factor 21 (FGF21) are elevated in patients with nonalcoholic fatty liver disease (NAFLD) and are useful markers for identifying or monitoring outcomes.,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': ''}, {'ForeName': 'Kazumichi', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': ''}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': ''}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okai', 'Affiliation': ''}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Ohira', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020399']
3376,32481440,Tamoxifen for amyotrophic lateral sclerosis: A randomized double-blind clinical trial.,"INTRODUCTION
Amyotrophic lateral sclerosis (ALS) is the most common cause of motor neuron disease, and effective treatment for ALS is still lacking. Transactive response (TAR) -DNA-binding protein-43 (TDP-43) is aggregated in the neurons of ALS patients. Animal studies shown TDP-43 aggregation can be attenuated by enhancing autophagy by tamoxifen. However, its beneficial effects for ALS patients remain unknown.
METHODS
Eighteen patients with ALS without mutations in superoxide dismutase-1 (SOD-1) or fused in sarcoma (FUS) genes were randomly assigned into the tamoxifen 40 mg/day or placebo group in a double-blinded manner and all were given riluzole twice daily. Participants were followed up at 1, 3, 6, and 12 months. The primary end point was time to death or dependence on mechanical ventilation. Secondary end points were decline of the revised ALS Functional Rating Scale (ALSFRS-R) score and pulmonary function measured by forced vital capacity (FVC).
RESULTS
Ten participants were randomly assigned in the treatment group with tamoxifen, 7 finished trial, 1 reach primary endpoint; while 8 participants in the placebo group, 2 finished trial and 2 reach primary end point. The proportion of participants reaching the primary end point was lower in the tamoxifen group but did not reach statistical significance. At the 1-, 3-, and 6-month follow-up, the average decline rates of the ALSFRS-R score were slower in the tamoxifen group. No significant difference was observed in FVC and ALSFRS-R score at 12 months between groups.
CONCLUSION
Tamoxifen exerted only a modest effect on attenuate progression for 6 months in this small trial. Additional larger scale studies should be necessary to confirm whether enhancing autophagy can attenuate ALS progression.",2020,"No significant difference was observed in FVC and ALSFRS-R score at 12 months between groups.
","['Eighteen patients with ALS without mutations in superoxide dismutase-1', 'neurons of ALS patients', 'amyotrophic lateral sclerosis']","['riluzole', 'Tamoxifen', 'tamoxifen 40\u200amg/day or placebo', 'tamoxifen', 'placebo']","['Transactive response (TAR) -DNA-binding protein-43 (TDP-43', 'FVC and ALSFRS-R score', 'decline of the revised ALS Functional Rating Scale (ALSFRS-R) score and pulmonary function measured by forced vital capacity (FVC', 'average decline rates of the ALSFRS-R score', 'attenuate progression', 'time to death or dependence on mechanical ventilation']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0669516', 'cui_str': 'Superoxide Dismutase 1'}, {'cui': 'C0027882', 'cui_str': 'Neuron'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C1132688', 'cui_str': 'Tamoxifen 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012940', 'cui_str': 'DNA Binding Protein'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439857', 'cui_str': 'Dependence'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",1.0,0.425237,"No significant difference was observed in FVC and ALSFRS-R score at 12 months between groups.
","[{'ForeName': 'Po-Chih', 'Initials': 'PC', 'LastName': 'Chen', 'Affiliation': 'Neurology Department, Shuang-Ho Hospital.'}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Hsieh', 'Affiliation': 'PhD Program for Neural Regenerative Medicine, College of Medical Science and Technology, Taipei Medical University and National Health Research Institutes.'}, {'ForeName': 'Chi-Chen', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'PhD Program for Neural Regenerative Medicine, College of Medical Science and Technology, Taipei Medical University and National Health Research Institutes.'}, {'ForeName': 'Chaur-Jong', 'Initials': 'CJ', 'LastName': 'Hu', 'Affiliation': 'Neurology Department, Shuang-Ho Hospital.'}]",Medicine,['10.1097/MD.0000000000020423']
3377,32481441,The 95% effective dose of nalbuphine in patient-controlled intravenous analgesia for patients undergoing laparoscopic total hysterectomy compared to equivalent sufentanil.,"PURPOSE
To evaluate the 95% effective dose of nalbuphine in patient-controlled intravenous analgesia (PCIA) by the sequential method and compare the analgesia efficacy with the equivalent dose of sufentanil on patients undergoing laparoscopic total hysterectomy.
METHODS
In the first part, we defined a successful analgesia as the highest VAS ≤3 in 24 hours postoperatively. On the contrary, a failed analgesia was the highest VAS>3. According to the last patient's outcome, the next patients would be given an increase or decreased dose grade. This process ended up with 9 cross-over points. In the second part, 60 patients undergoing laparoscopic total hysterectomy were selected. They were randomly divided into 2 groups (n = 30 each group): receiving sufentanil 1.78 μg/kg (group S) and nalbuphine 1.78 mg/kg (group N). PCIA pump was given at the end of the operation with 5 mL bonus loading. The total amount of PCIA was 100 mL and programmed to deliver 0.5 mL each time with a lockout interval of 15 minutes and the background infusion amount of 2 mL/h. The VAS score and Ramsay score of were collected after the operation, the number of effective pressing times of PCIA were also recorded. Adverse reactions were documented in detail.
RESULTS
The 95% effective dose of nalbuphine in PCIA on patients undergoing laparoscopic total hysterectomy was 1.78 mg/kg. There was no significant difference in VAS between the sufentanil group and the nalbuphine groups (P > .05), but the number of the use of PCIA in the group S was more than that in the group N obviously (P <.05). The group S has a lower ramsay sedation score than group N at every time point. (P <.05). The incidence of nausea and vomiting was not statistically significant differences between two groups in the first 24 hours after colonoscopy (P > q .05).
CONCLUSION
Nalbuphine 1.78 mg/kg in PCIA is recommended for the patients undergoing laparoscopic total hysterectomy. And nalbuphine is a reasonable alternative to sufentanil when used in PCIA.",2020,"The incidence of nausea and vomiting was not statistically significant differences between two groups in the first 24 hours after colonoscopy (P > q .05).
","['60 patients undergoing laparoscopic total hysterectomy were selected', 'patients undergoing laparoscopic total hysterectomy', 'patient-controlled intravenous analgesia (PCIA']","['nalbuphine', 'PCIA pump', 'sufentanil 1.78\u200aμg/kg (group S) and nalbuphine 1.78\u200amg/kg', 'sufentanil', 'Nalbuphine 1.78\u200amg/kg in PCIA']","['VAS score and Ramsay score', 'ramsay sedation score', 'number of the use of PCIA', 'VAS', 'nausea and vomiting', 'analgesia efficacy', 'number of effective pressing times of PCIA', 'Adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0404090', 'cui_str': 'Laparoscopic total hysterectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",60.0,0.0470313,"The incidence of nausea and vomiting was not statistically significant differences between two groups in the first 24 hours after colonoscopy (P > q .05).
","[{'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020424']
3378,32481442,Effects of mild hypothermia on serum HMGB1 of brain-dead donors and its impact on kidney transplantation recipients.,"Investigate the effect of mild hypothermia on serum inflammatory factor HMGB1 of brain-dead donors, and its significance for renal transplantation recipients.In our hospital between January 2018 and January 2019 up to the standard of brain death donor (aged 18 to 65 years old) prospective cohort study, brain death donor were randomly divided into mild hypothermia group and the non-mild hypothermia group. Serum were collected from donor at different periods, and enzyme-linked immunoassay (ELISA) was used to determine the serum HMGB1 concentration to compare the difference between the 2 donor groups. The early recovery of renal function after renal transplantation was followed up, and the incidence of delayed graft function (DGF) and early recovery of renal function were compared between the 2 groups. The correlation between donor HMGB1 and recipient DGF was analyzed.Between 17 donors in the mild hypothermia group and 17 in the non-mild hypothermia group, there were no statistically significant differences in the age, perioperative urine volume and ICU stay between the 2 groups. After mild hypothermia treatment, serum HMGB1 levels of brain death donors were significantly decreased. While in non-mild hypothermia brain death donor group without treatment, serum HMGB1 was significantly increased. There were no statistically significant differences in age and preoperative creatinine between the 2 recipient groups, including 33 patients in the mild hypothermia group and 34 patients in the non-mild hypothermia group. DGF incidence was lower in mild hypothermia group comparing with non-mild hypothermia group with statistical significance. The levels of HMGB1 from donor before procurement is correlated with the occurrence of DGF of the recipient.Mild hypothermia therapy can reduce the levels of serum HMGB1, improve the function of donor organs. The levels of HMGB1 before donor procurement can be used to predict the occurrence of DGF in kidney transplant recipients. Our study shows that HMGB1 can be potentially used as therapeutic target of early intervention for brain death donors. Furthermore, mild hypothermia therapy can be applied in the maintenance of brain death donors for kidney transplant recipient to improve the successful rate of transplantation.",2020,The levels of HMGB1 before donor procurement can be used to predict the occurrence of DGF in kidney transplant recipients.,"['renal transplantation recipients', 'In our hospital between January 2018 and January 2019 up to the standard of brain death donor (aged 18 to 65 years old) prospective cohort study, brain death donor', 'kidney transplant recipients', 'kidney transplantation recipients']","['Mild hypothermia therapy', 'mild hypothermia group and the non-mild hypothermia group', 'HMGB1', 'mild hypothermia']","['delayed graft function (DGF) and early recovery of renal function', 'renal function', 'serum HMGB1', 'levels of serum HMGB1', 'DGF incidence', 'age and preoperative creatinine', 'serum HMGB1 levels of brain death donors', 'age, perioperative urine volume and ICU stay', 'HMGB1 concentration']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0445043', 'cui_str': 'Mild hypothermia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}]","[{'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0150513,The levels of HMGB1 before donor procurement can be used to predict the occurrence of DGF in kidney transplant recipients.,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shan', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Zhe-Min', 'Initials': 'ZM', 'LastName': 'Lin', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Xue-Zhu', 'Initials': 'XZ', 'LastName': 'Wang', 'Affiliation': 'Office of Organ Donation and Transplantation Management.'}, {'ForeName': 'Zi-Xin', 'Initials': 'ZX', 'LastName': 'Mi', 'Affiliation': 'Office of Organ Donation and Transplantation Management.'}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Office of Organ Donation and Transplantation Management.'}, {'ForeName': 'Zi-Ren', 'Initials': 'ZR', 'LastName': 'Tang', 'Affiliation': 'Department of Emergency, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology.'}]",Medicine,['10.1097/MD.0000000000020425']
3379,32481469,Total bile acid to platelet ratio: A noninvasive index for predicting liver fibrosis in primary biliary cholangitis.,"The aim of the study was to develop a new early noninvasive diagnostic model for primary biliary cholangitis (PBC).A total of 118 PBC patients who had undergone a liver biopsy were enrolled in the study, and were randomized into a model group (78 patients) and a validation group (40 patients). The patients' histological stages were based on the classifications of the Scheuer's stage. All common parameters and liver pathological results were analyzed. And total bile acid to platelet ratio, aspartate aminotransferase to platelet ratio index, fibrosis index based on 4 factors and red cell distribution width to platelet ratio were calculated.There were 106 (89.8%) women and 12 men in this study, and the number of patients in Scheuer stage I, II, III, and IV hepatic fibrosis was 52 (44.1%), 36 (30.5%), 26 (22.0%), and 4 (3.4%), respectively. The areas under the receiver operating characteristic curves of the total bile acid to platelet ratio (TPR), the aspartate aminotransferase to platelet ratio index, the fibrosis index based on 4 factors , and the red cell distribution width to platelet ratio for predicting advanced liver fibrosis were 0.771, 0.715, 0.618, and 0.517 respectively. The areas under the receiver operating characteristic curves of the TPR was higher than other non-invasive serological models.As a simple, inexpensive and easily accessible non-invasive liver fibrosis diagnostic model, the TPR may be a new noninvasive marker for predicting histologic severity of PBC.",2020,The areas under the receiver operating characteristic curves of the TPR was higher than other non-invasive serological models.,"['primary biliary cholangitis', 'primary biliary cholangitis ', '118 PBC patients who had undergone a liver biopsy']",['PBC).A'],"['Total bile acid to platelet ratio', 'IV hepatic fibrosis', 'total bile acid to platelet ratio (TPR), the aspartate aminotransferase to platelet ratio index, the fibrosis index based on 4 factors , and the red cell distribution width to platelet ratio for predicting advanced liver fibrosis', 'And total bile acid to platelet ratio, aspartate aminotransferase to platelet ratio index, fibrosis index based on 4 factors and red cell distribution width to platelet ratio']","[{'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0201914', 'cui_str': 'Total bile acids measurement'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427460', 'cui_str': 'Red cell distribution width determination'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]",118.0,0.0184379,The areas under the receiver operating characteristic curves of the TPR was higher than other non-invasive serological models.,"[{'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatology, the First Hospital of Jilin University, Changchun, Jilin Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Youyou', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Luyuan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Pujun', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020502']
3380,32481473,Effects of compound Caoshi silkworm granules on stable COPD patients and their relationship with gut microbiota: A randomized controlled trial.,"BACKGROUND AND PURPOSE
Patients with chronic obstructive pulmonary disease (COPD) usually experience recurrent acute exacerbations. These patients, especially those with stable COPD, require an effective intervention for treating exacerbations. This study aimed to evaluate the efficacy of Compound Caoshi silkworm granules (CCSGs) in stable COPD patients and to investigate their potential mechanism.
METHODS
A randomized controlled trial was performed at Jinhua Hospital, Zhejiang University. Patients were enrolled in this study if they met the criterion of stable COPD. A total of 40 patients were randomly divided into the following 2 groups: Group A (n = 20, routine treatment (RT) group) and Group B (n = 20, RT plus CCSGs [RT plus CCSGs] group). The duration of treatment was 3 months. Stool samples were collected from all patients on day 0 and the gut microbiota was analyzed using 16s rRNA sequencing. The St. George's Respiratory Questionnaire (SGRQ) scores and lung function were assessed at month 0 and month 3.
RESULTS
The components of gut microbiota differed between stable COPD patients and the healthy population. The RT plus CCSGs group showed improved SGRQ scores compared to the RT group. There was no difference in forced expiratory volume-one second, forced vital capacity, and forced expiratory volume-one second/forced vital capacity between the two groups. Furthermore, the abundance of gut microbiota in patients with the top 10 SGRQ scores (Group N) differed from the abundance of gut microbiota in those with the lowest 10 SGRQ scores (Group T).
CONCLUSION
CCSGs have beneficial effects in the improvement of symptoms in stable COPD patients over a 3-month treatment period. The potential underlying mechanism may be attributable to the difference in gut microbiota among patients. However, more research is needed to confirm this conclusion.",2020,"There was no difference in forced expiratory volume-one second, forced vital capacity, and forced expiratory volume-one second/forced vital capacity between the two groups.","['stable COPD patients and the healthy population', 'stable COPD patients', '40 patients', 'Patients with chronic obstructive pulmonary disease (COPD) usually experience recurrent acute exacerbations', 'stable COPD patients and their relationship with gut microbiota', 'Jinhua Hospital, Zhejiang University']","['RT plus CCSGs [RT plus CCSGs', 'compound Caoshi silkworm granules', 'Compound Caoshi silkworm granules (CCSGs']","['abundance of gut microbiota', 'forced expiratory volume-one second, forced vital capacity, and forced expiratory volume-one second/forced vital capacity', 'SGRQ scores', 'scores and lung function', ""St. George's Respiratory Questionnaire (SGRQ""]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439589', 'cui_str': 'Recurrent acute'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0037119', 'cui_str': 'Bombyx'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.0324333,"There was no difference in forced expiratory volume-one second, forced vital capacity, and forced expiratory volume-one second/forced vital capacity between the two groups.","[{'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, Jinhua, Zhejiang.'}, {'ForeName': 'Qinghuan', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'School of Medicine. Zhejiang Chinese Medical University.'}, {'ForeName': 'Songmin', 'Initials': 'S', 'LastName': 'Ying', 'Affiliation': 'Department of Pharmacology and Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital, Institute of Respiratory Diseases, Zhejiang University School of Medicine, Hangzhou.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Respiratory Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Xiguang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Jilin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Respiratory Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Feila', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmacy, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University.'}, {'ForeName': 'Feibao', 'Initials': 'F', 'LastName': 'Tao', 'Affiliation': 'Department of Traditional Chinese Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, Jinhua, Zhejiang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Traditional Chinese Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, Jinhua, Zhejiang, China.'}]",Medicine,['10.1097/MD.0000000000020511']
3381,32481760,"Oral Intake of Hydrangea serrata (Thunb.) Ser. Leaves Extract Improves Wrinkles, Hydration, Elasticity, Texture, and Roughness in Human Skin: A Randomized, Double-Blind, Placebo-Controlled Study.","Previously, we reported that the hot water extract of Hydrangea serrata leaves (WHS) and its active component, hydrangenol, possess in vitro and in vivo effects on skin wrinkles and moisturization. We conducted a randomized, double-blind, placebo-controlled trial to clinically evaluate the effect of WHS on human skin. Participants ( n = 151) were randomly assigned to receive either WHS 300 mg, WHS 600 mg, or placebo, once daily for 12 weeks. Skin wrinkle, hydration, elasticity, texture, and roughness parameters were assessed at baseline and after 4, 8, and 12 weeks. Compared to the placebo, skin wrinkles were significantly reduced in both WHS groups after 8 and 12 weeks. In both WHS groups, five parameters (R1-R5) of skin wrinkles significantly improved and skin hydration was significantly enhanced when compared to the placebo group after 12 weeks. Compared with the placebo, three parameters of skin elasticity, including overall elasticity (R2), net elasticity (R5), and ratio of elastic recovery to total deformation (R7), improved after 12 weeks of oral WHS (600 mg) administration. Changes in skin texture and roughness were significantly reduced in both WHS groups. No WHS-related adverse reactions were reported. Hence, WHS could be used as a health supplement for skin anti-aging.",2020,"In both WHS groups, five parameters (R1-R5) of skin wrinkles significantly improved and skin hydration was significantly enhanced when compared to the placebo group after 12 weeks.","['human skin', 'Participants ( n = 151']","['Placebo', 'WHS', 'oral WHS', 'WHS 300 mg, WHS 600 mg, or placebo', 'Hydrangea serrata (Thunb', 'placebo']","['Wrinkles, Hydration, Elasticity, Texture, and Roughness in Human Skin', 'Skin wrinkle, hydration, elasticity, texture, and roughness parameters', 'skin wrinkles', 'skin elasticity, including overall elasticity (R2), net elasticity (R5), and ratio of elastic recovery to total deformation (R7', 'adverse reactions', 'skin hydration', 'skin texture and roughness']","[{'cui': 'C3859811', 'cui_str': 'human skin preparation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1956097', 'cui_str': 'Wolf Hirschhorn syndrome'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0330862', 'cui_str': 'Hydrangea'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}]",151.0,0.277195,"In both WHS groups, five parameters (R1-R5) of skin wrinkles significantly improved and skin hydration was significantly enhanced when compared to the placebo group after 12 weeks.","[{'ForeName': 'Da-Bin', 'Initials': 'DB', 'LastName': 'Myung', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Jeong-Hun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Kwang-Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Hye Shin', 'Initials': 'HS', 'LastName': 'Ahn', 'Affiliation': 'Department of New Material Development, COSMAXBIO, Seongnam 13486, Korea.'}, {'ForeName': 'Yu-Kyong', 'Initials': 'YK', 'LastName': 'Shin', 'Affiliation': 'Department of New Material Development, COSMAXBIO, Seongnam 13486, Korea.'}, {'ForeName': 'Eunjung', 'Initials': 'E', 'LastName': 'Song', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul 02447, Korea.'}, {'ForeName': 'Bo-Hyung', 'Initials': 'BH', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul 02447, Korea.'}, {'ForeName': 'Kwang Hoon', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Global Medical Research Center, Seoul 06035, Korea.'}, {'ForeName': 'Sun Hee', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of New Material Development, COSMAXBIO, Seongnam 13486, Korea.'}, {'ForeName': 'Kyung-Tae', 'Initials': 'KT', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.'}]",Nutrients,['10.3390/nu12061588']
3382,32482032,[A comparative study of total laparoscopic and laparoscopic-assisted simultaneous resection for colorectal cancer liver metastasis].,"Objective: To compare the safety and outcome between total laparoscopic and laparoscopy-assisted synchronous resection for colorectal cancer patients with liver metastases. Methods: The data of patients who underwent total laparoscopic or laparoscopy-assisted simultaneous resection of primary colorectal cancer and liver metastases in our hospital between December 2008 and December 2016 were collected and analyzed. The total laparoscopic surgery patients were matched 1∶2 to the laparoscopy-assisted surgery patients based on the propensity score. 22 patients were classified in the total laparoscopic group and 44 patients were classified in the laparoscopy-assisted group. The intraoperative conditions and postoperative outcomes of the two groups were compared. Results: There was no difference in the preoperative baseline data between the two groups ( P >0.05). The median operative time were 317.50 and 267.50 minutes in the total laparoscopic group and the laparoscopy-assisted group, respectively, and the median intraoperative blood loss were 100 and 200 ml, both with no statistically significant differences ( P >0.05). There were 1 case of intraoperative blood transfusion in the total laparoscopic group and 5 cases in the laparoscopy-assisted group, with no statistically significant difference ( P =0.650). The median postoperative hospital stay in the two groups were 11.0 and 10.0 days, the median postoperative defecation time were 4.0 and 4.0 days and postoperative complication rates were 13.6% and 20.5%, and none of these differences were statistically significant ( P >0.05). However, no Clavien-DindoⅡ level and above complications occurred in total laparoscopic group. The median disease-free survival (DFS) were 15.0 and 15.7 months in the total laparoscopic group and the laparoscopy-assisted group, the overall survival (OS) were 25.9 and 37.6 months, respectively, with no statistically significant differences ( P >0.05). Conclusion: Laparoscopy-assisted approaches are similar, so the appropriate approach should be chosen according to the clinical condition and surgeon's experience.",2020,"There were 1 case of intraoperative blood transfusion in the total laparoscopic group and 5 cases in the laparoscopy-assisted group, with no statistically significant difference ( P =0.650).","['22 patients were classified in the total laparoscopic group and 44 patients were classified in the laparoscopy-assisted group', 'colorectal cancer liver metastasis', 'of primary colorectal cancer and liver metastases in our hospital between December 2008 and December 2016 were collected and analyzed', 'colorectal cancer patients with liver metastases']","['total laparoscopic or laparoscopy-assisted simultaneous resection', 'total laparoscopic and laparoscopy-assisted synchronous resection', 'total laparoscopic and laparoscopic-assisted simultaneous resection', 'laparoscopy-assisted surgery']","['postoperative complication rates', 'intraoperative conditions and postoperative outcomes', 'median disease-free survival (DFS', 'median intraoperative blood loss', 'median postoperative defecation time', 'Clavien-DindoⅡ level and above complications', 'preoperative baseline data', 'median operative time', 'intraoperative blood transfusion', 'median postoperative hospital stay', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",22.0,0.0575017,"There were 1 case of intraoperative blood transfusion in the total laparoscopic group and 5 cases in the laparoscopy-assisted group, with no statistically significant difference ( P =0.650).","[{'ForeName': 'X C', 'Initials': 'XC', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Z Y', 'Initials': 'ZY', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Z W', 'Initials': 'ZW', 'LastName': 'Luo', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Bi', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'J Q', 'Initials': 'JQ', 'LastName': 'Cai', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}]",Zhonghua zhong liu za zhi [Chinese journal of oncology],['10.3760/cma.j.cn112152-112152-20190814-00526']
3383,32304283,Efficacy and safety of metformin and sitagliptin-based dual and triple therapy in elderly Chinese patients with type 2 diabetes: Subgroup analysis of STRATEGY study.,"AIMS/INTRODUCTION
To assess the efficacy and safety of metformin/sitagliptin-based dual/triple therapy in elderly Chinese patients with type 2 diabetes mellitus.
MATERIALS AND METHODS
This subgroup analysis included individuals aged ≥65 years from the STRATEGY study, a two-stage study in which type 2 diabetes mellitus patients with unsatisfactory glycemic control on metformin were first treated with the dual combination of metformin and sitagliptin for 16 weeks (n = 681), and then, if glycemic control had not been achieved, were treated with a third add-on oral antihyperglycemic drug for another 24 weeks (n = 291). The efficacy end-point was change in glycated hemoglobin (HbA1c) in each stage, and the safety end-point was adverse events with a focus on hypoglycemia.
RESULTS
At week 16, the change in HbA1c was -0.81% from baseline, and the percentages of patients who achieved HbA1c targets of <7% and <7.5% were 44.9 and 67.2%, respectively. After 24 weeks, a further average HbA1c reduction of -0.60% was observed with specific reductions of -0.70% with glimepiride, -0.63% with gliclazide, -0.51% with repaglinide and -0.45% with acarbose. The proportions of patients who achieved HbA1c targets of <7% and <7.5% were 65.4 and 81.3%, respectively, over the entire study. The rates of drug-related adverse events and hypoglycemia were, respectively, 4.1 and 4.3% in the dual therapy stage, and 5.2% and 7.1% in the triple therapy stage, without occurrence of severe hypoglycemia.
CONCLUSIONS
In elderly Chinese type 2 diabetes mellitus patients, metformin/sitagliptin-based dual and triple oral therapy can provide clinically meaningful glycemic control and is generally well tolerated with a low incidence of hypoglycemia.",2020,"The rates of drug-related adverse events and hypoglycemia were, respectively, 4.1 and 4.3% in the dual therapy stage, and 5.2% and 7.1% in the triple therapy stage, without occurrence of severe hypoglycemia.
","['elderly Chinese type\xa02 diabetes mellitus patients', 'individuals aged ≥65\xa0years from the STRATEGY study, a two-stage study in which type\xa02 diabetes mellitus patients with unsatisfactory glycemic control on metformin were first treated with the dual combination of', 'elderly Chinese patients with type\xa02 diabetes mellitus', 'elderly Chinese patients with type\xa02 diabetes']","['gliclazide', 'repaglinide', 'metformin and sitagliptin-based dual and triple therapy', 'acarbose', 'metformin and sitagliptin', 'metformin/sitagliptin-based dual and triple oral therapy', 'glimepiride', 'metformin/sitagliptin-based dual/triple therapy']","['Efficacy and safety', 'efficacy and safety', 'rates of drug-related adverse events and hypoglycemia', 'change in HbA1c', 'glycated hemoglobin (HbA1c']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C1952576', 'cui_str': 'metformin and sitagliptin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0406655,"The rates of drug-related adverse events and hypoglycemia were, respectively, 4.1 and 4.3% in the dual therapy stage, and 5.2% and 7.1% in the triple therapy stage, without occurrence of severe hypoglycemia.
","[{'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Longyi', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Guojuan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'MSD China Holding Co., Ltd., Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'MSD China Holding Co., Ltd., Shanghai, China.'}, {'ForeName': 'Ruya', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'MSD China Holding Co., Ltd., Shanghai, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'MSD R&D (China) Co., Ltd., Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}]",Journal of diabetes investigation,['10.1111/jdi.13277']
3384,32307568,Relationship between molecular response and quality of life with bosutinib or imatinib for chronic myeloid leukemia.,"Patients with newly diagnosed chronic phase chronic myeloid leukemia (CP CML) can be effectively treated with tyrosine kinase inhibitors (TKIs) and achieve a lifespan similar to the general population. The success of TKIs, however, requires long-term and sometimes lifelong treatment; thus, patient-assessed health-related quality of life (HRQoL) has become an increasingly important parameter for treatment selection. Bosutinib is a TKI approved for CP CML in newly diagnosed adults and in those resistant or intolerant to prior therapy. In the Bosutinib Trial in First-Line Chronic Myelogenous Leukemia Treatment (BFORE), bosutinib demonstrated a significantly higher major molecular response rate compared with imatinib, with maintenance of HRQoL (measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire), after 12 months of first-line treatment. We examined relationships between molecular response (MR) and HRQoL. MR values were represented by a log-reduction scale (MRLR; a continuous variable). A repeated-measures longitudinal model was used to estimate the relationships between MRLR as a predictor and each FACT-Leu domain as an outcome. Effect sizes were calculated to determine strength of effects and allow comparisons across domains. The majority of FACT-Leu domains (with the exception of social well-being and physical well-being) demonstrated a significant relationship with MRLR (p < 0.05). Our results showed variable impact of clinical improvement on different dimensions of HRQoL. For patients who achieved MR 5 , emotional well-being and leukemia-specific domains showed the greatest improvement, with medium differences in effect sizes, whereas social well-being and physical well-being had the weakest relationship with MR.",2020,"For patients who achieved MR 5 , emotional well-being and leukemia-specific domains showed the greatest improvement, with medium differences in effect sizes, whereas social well-being and physical well-being had the weakest relationship with MR.","['Patients with newly diagnosed chronic phase chronic myeloid leukemia (CP CML', 'chronic myeloid leukemia']","['tyrosine kinase inhibitors (TKIs', 'HRQoL', 'bosutinib or imatinib']",['molecular response (MR) and HRQoL. MR values'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023474', 'cui_str': 'Chronic phase chronic myeloid leukemia'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}]","[{'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1831731', 'cui_str': 'bosutinib'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0288554,"For patients who achieved MR 5 , emotional well-being and leukemia-specific domains showed the greatest improvement, with medium differences in effect sizes, whereas social well-being and physical well-being had the weakest relationship with MR.","[{'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': 'Universitätsklinikum RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany. tbruemmendorf@ukaachen.de.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Gambacorti-Passerini', 'Affiliation': 'University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Bushmakin', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cappelleri', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Viqueira', 'Affiliation': 'Pfizer SLU, Madrid, Spain.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Reisman', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Isfort', 'Affiliation': 'Universitätsklinikum RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Mamolo', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}]",Annals of hematology,['10.1007/s00277-020-04018-1']
3385,32482147,Comparative measurement properties of constant work rate cycling and the endurance shuttle walking test in COPD: the TORRACTO ® clinical trial.,"BACKGROUND
Exercise tolerance is an important endpoint in chronic obstructive pulmonary disease (COPD) clinical trials. Little is known about the comparative measurement properties of constant work rate cycle ergometry (CWRCE) and the endurance shuttle walking test (ESWT). The objective of this sub-analysis of the TORRACTO ® study was to directly compare the endurance measurement properties of CWRCE and ESWT in patients with COPD in a multicentre, multinational setting. We predicted that both tests would be similarly reliable, but that the ESWT would be more responsive to bronchodilation than CWRCE.
METHODS
This analysis included 151 patients who performed CWRCE and ESWT at baseline and week 6 after receiving once-daily placebo, tiotropium/olodaterol (T/O) 2.5/5 μg or T/O 5/5 μg. Reproducibility was assessed by comparing their respective performance at baseline and week 6 in the placebo group. Responsiveness to bronchodilation was assessed by comparing endurance time at week 6 with T/O with baseline values and placebo. The locus of symptom limitation and end-exercise Borg scales for breathing and leg discomfort for both tests were also analysed.
RESULTS
The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37-0.71] and 0.75 (95% CI 0.63-0.84). More patients were limited by breathing discomfort during the ESWT than during CWRCE, whereas more patients were limited by leg discomfort or breathing/leg discomfort during CWRCE than the ESWT ( p <0.0001). Both tests were responsive to bronchodilator treatment: there was a 19% increase in endurance time from baseline at week 6 ( p = 0.0006) assessed with CWRCE, and a 20% increase in endurance time assessed with ESWT ( p = 0.0013).
CONCLUSIONS
Both exercise tests performed well in a multicentre clinical trial. Although the locus of symptom limitation differed between the two tests, both were reliable and responsive to bronchodilation. For future clinical trials, the choice of test should depend on the study requirements.
CLINICALTRIALS.GOV IDENTIFIER
NCT01525615. The reviews of this paper are available via the supplemental material section.",2020,The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37-0.71] and 0.75 (95% CI 0.63-0.84).,"['chronic obstructive pulmonary disease (COPD', 'patients with COPD in a multicentre, multinational setting', 'COPD', '151 patients who performed CWRCE and ESWT at baseline and week 6 after receiving once-daily']","['ESWT', 'endurance shuttle walking test', 'placebo, tiotropium/olodaterol (T/O) 2.5/5\u2009μg or T', 'placebo']","['endurance time assessed with ESWT', 'endurance time', 'Reproducibility', 'leg discomfort or breathing/leg discomfort', 'breathing discomfort']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}, {'cui': 'C0859235', 'cui_str': 'Leg discomfort'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",151.0,0.220765,The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37-0.71] and 0.75 (95% CI 0.63-0.84).,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Research Centre, Institut universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, 2725 Chemin Sainte-Foy, Québec, G1V 4G5, Canada.'}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University and Kingston Health Sciences Centre, Kingston, ON, Canada.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hamilton', 'Affiliation': 'Medical Department, Boehringer Ingelheim, Burlington, ON, Canada.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Rehabilitation Clinical Trial Centre, Los Angeles Biomedical Research Institute at Harbour-UCLA Medical Centre, Torrance, CA, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620926858']
3386,32482174,Using the axillary reverse mapping technique to screen breast cancer patients with a high risk of lymphedema.,"BACKGROUND
Preventing breast cancer-related lymphedema (BCRL) by preserving upper lymphatic drainage is still controversial. Our study aimed to use the axillary reverse mapping (ARM) technique in patients who underwent axillary surgery to analyse the correlation between postoperative residual ARM nodes and the occurrence of lymphedema, select candidates at high risk of developing lymphedema, and analyse the oncologic safety of ARM nodes.
METHODS
Patients undergoing sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) from October 2015 to February 2016 at the Peking University People's Hospital Breast Center were prospectively recruited for the study. ARM was performed in all patients before surgery. ARM nodes were separated from SLNB and ALND specimens. Data were collected on the identification of ARM nodes before surgery, number of residual ARM nodes after surgery, nodal status, crossover rate, and correlation between residual ARM nodes and the occurrence of lymphedema.
RESULTS
The analysis included 78 patients. Of the 53 patients who underwent SLNB, crossover between ARM nodes and breast sentinel lymph nodes (SLNs) was seen in 22 specimens. The incidence of ARM node metastasis was 1.89% (1/53) and 25% (9/36) in the SLNB and ALND groups, respectively. The number of positive axillary lymph nodes was associated with the involvement of ARM nodes (P = 0.036). The incidence of residual ARM nodes was significantly higher in the SLNB group than in the ALND group (67.6% vs. 37.9%, P = 0.016). The incidence of lymphedema was significantly higher in the ALND group than in the SLNB group (33.3% vs. 5.4%, P = 0.003).
CONCLUSIONS
For SLNB, the ARM technique can help to resect SLNs more accurately. However, we do not recommend using the ARM technique to preserve ARM nodes in patients undergoing ALND due to oncologic safety issues. Nevertheless, we can predict patients undergoing axillary surgery who are more likely to have a high risk of lymphedema by assessing residual ARM nodes.
TRIAL REGISTRATION
This study was registered on ClinicalTrials.gov in February 2016. The clinical trial registration number is NCT02691624.",2020,The number of positive axillary lymph nodes was associated with the involvement of ARM nodes (P = 0.036).,"['patients undergoing axillary surgery who are more likely to have a high risk of lymphedema by assessing residual ARM nodes', '78 patients', ""Patients undergoing sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) from October 2015 to February 2016 at the Peking University People's Hospital Breast Center were prospectively recruited for the study"", 'patients who underwent axillary surgery', 'screen breast cancer patients with a high risk of lymphedema', '53 patients who underwent SLNB, crossover between ARM nodes and breast sentinel lymph nodes (SLNs) was seen in 22 specimens']","['ALND', 'axillary reverse mapping (ARM) technique', 'SLNB', 'axillary reverse mapping technique']","['number of positive axillary lymph nodes', 'incidence of lymphedema', 'incidence of residual ARM nodes', 'incidence of ARM node metastasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0594634,The number of positive axillary lymph nodes was associated with the involvement of ARM nodes (P = 0.036).,"[{'ForeName': 'Siyao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""Nuclear Medicine Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Houpu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China. liumiao@pkuph.edu.cn.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China. shuwang@pkuph.edu.cn.""}]",World journal of surgical oncology,['10.1186/s12957-020-01886-9']
3387,32482335,Effectiveness of oral moisturizing gel and flavor on oral moisture and saliva volume: A clinical study.,"STATEMENT OF PROBLEM
Oral dryness leads to problems in the oral cavity and pharynx and problems with dental prostheses. Although some moisturizing agents relieve the symptoms of oral dryness, the influence of the flavor of the moisturizing agent on the symptoms of oral dryness has not been clarified.
PURPOSE
The purpose of this clinical study was to examine the effectiveness of moisturizing gels with different flavors.
MATERIAL AND METHODS
Participants in this study consisted of 36 healthy adults and 20 individuals with oral dryness. They were randomly divided into 6 groups, and moisturizing gels with 5 different flavors (tasteless and odorless, sweet taste, acid taste with citric acid, acid taste with Japanese apricot extract, and Japanese apricot scent) were tested in 5 of the groups with 1 group acting as the control (no gel administered). Oral moisture and saliva volume were measured before applying the moisturizing gel, just after applying the moisturizing gel, and 10, 20, and 30 minutes after applying the moisturizing gel. Differences in oral moisture and saliva volume according to the gel flavor and duration of contact were analyzed by using 2-way analysis of variance (α=.05).
RESULTS
Oral moisture did not differ among the gel flavors and the duration of contact. Saliva volume in the control (no gel administered) reported no statistically significant differences among any of the contact durations in both healthy adults and participants with oral dryness. The saliva volume in healthy adults increased after using the sweet taste (P=.012), acid taste with Japanese apricot extract (P=.006), and Japanese apricot scent (P=.005) moisturizing gels. The saliva volume in participants with oral dryness increased rapidly just after using the acid taste with Japanese apricot extract gel (P=.008) and increased slowly after applying the tasteless and odorless (P=.046), sweet taste (P=.048), and acid taste with citric acid moisturizing gels (P=.010).
CONCLUSIONS
The effectiveness of moisturizing gel for increasing saliva secretion differed according to the flavor of the moisturizing gel. This suggests that the moisturizing gel's effect on increasing saliva secretion is related to the flavor of the gel in addition to the moisturizing agent.",2020,"The saliva volume in healthy adults increased after using the sweet taste (P=.012), acid taste with Japanese apricot extract (P=.006), and Japanese apricot scent (P=.005) moisturizing gels.","['healthy adults', 'healthy adults and participants with oral dryness', 'Participants in this study consisted of 36 healthy adults and 20 individuals with oral dryness']","['oral moisturizing gel and flavor', 'acid taste with Japanese apricot extract', 'moisturizing gels with 5 different flavors (tasteless and odorless, sweet taste, acid taste with citric acid, acid taste with Japanese apricot extract, and Japanese apricot scent', 'moisturizing gel']","['saliva secretion', 'duration of contact', 'Saliva volume', 'saliva volume', 'Oral moisture and saliva volume', 'oral moisture and saliva volume']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C3488990', 'cui_str': 'apricot extract'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0003638', 'cui_str': 'Apricot'}, {'cui': 'C0031516', 'cui_str': 'Recognition odor'}]","[{'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",36.0,0.021413,"The saliva volume in healthy adults increased after using the sweet taste (P=.012), acid taste with Japanese apricot extract (P=.006), and Japanese apricot scent (P=.005) moisturizing gels.","[{'ForeName': 'Fumi', 'Initials': 'F', 'LastName': 'Mizuhashi', 'Affiliation': 'Assistant Professor, Department of Removable Prosthodontics, The Nippon Dental University School of Life Dentistry at Niigata, Niigata, Japan. Electronic address: fumichan@ngt.ndu.ac.jp.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Koide', 'Affiliation': 'Professor, Department of Removable Prosthodontics, The Nippon Dental University School of Life Dentistry at Niigata, Niigata, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Toya', 'Affiliation': 'Professor, Dry Mouth Clinic, Oral and Maxillofacial Surgery, The Nippon Dental University Niigata Hospital, Niigata, Japan.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.02.031']
3388,32482355,[Effects of remifentanil on awakening of propofol sedated patients submitted to upper gastrointestinal endoscopy: a randomized clinical trial].,"BACKGROUND AND OBJECTIVES
Sedation for endoscopic procedures aims to provide high quality sedation, lower risks, short recovery time, superior recovery quality and absence of side effects, seeking high patient level of satisfaction. The goal of the study was to assess administration of remifentanil combined with propofol regarding the effects of the drug association during sedation and recovery for patients submitted to upper GI diagnostic endoscopy.
METHOD
One hundred and five patients were assessed, randomly divided into three groups of 35 patients. The Control Group was sedated with propofol alone. Study Group 1 was sedated with a fixed dose of 0.2 μg.kg -1 remifentanil combined with propofol. Study Group 2 was sedated with 0.3 μg.kg -1 remifentanil combined with propofol. We assessed the quality of sedation, hemodynamic parameters, incidence of significant hypoxemia, time for spontaneous eye opening, post-anesthetic recovery time, quality of post-anesthetic recovery, presence of side effects and patient satisfaction.
RESULTS
Study Group 1 showed better quality of sedation. The groups in which remifentanil was administered combined with propofol showed shorter eye-opening time and shorter post-anesthetic recovery time compared to the control group. The three groups presented hemodynamic changes at some of the moments assessed. The incidence of significant hypoxemia, the quality of post-anesthetic recovery, the incidence of side effects and patient satisfaction were similar in the three groups.
CONCLUSIONS
The combination of propofol with remifentanil at a dose of 0.2 μg.kg -1 was effective in improving the quality of sedation, and at doses of 0.2 μg.kg -1 and 0.3 μg.kg -1 reduced the time to spontaneous eye opening and post-anesthetic recovery in comparison to sedation with propofol administered alone.",2020,"The incidence of significant hypoxemia, the quality of post-anesthetic recovery, the incidence of side effects and patient satisfaction were similar in the three groups.
","['awakening of propofol sedated patients submitted to upper gastrointestinal endoscopy', 'One hundred and five patients', 'patients submitted to upper GI diagnostic endoscopy']","['propofol with remifentanil', 'remifentanil combined with propofol', 'remifentanil', 'propofol alone', 'propofol']","['hemodynamic changes', 'quality of sedation, hemodynamic parameters, incidence of significant hypoxemia, time for spontaneous eye opening, post-anesthetic recovery time, quality of post-anesthetic recovery, presence of side effects and patient satisfaction', 'shorter eye-opening time and shorter post-anesthetic recovery time', 'incidence of significant hypoxemia, the quality of post-anesthetic recovery, the incidence of side effects and patient satisfaction', 'quality of sedation']","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0203057', 'cui_str': 'Upper gastrointestinal tract series'}, {'cui': 'C0497101', 'cui_str': 'Diagnostic endoscopy'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",105.0,0.0770421,"The incidence of significant hypoxemia, the quality of post-anesthetic recovery, the incidence of side effects and patient satisfaction were similar in the three groups.
","[{'ForeName': 'Gustavo Nadal', 'Initials': 'GN', 'LastName': 'Uliana', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Programa de Pós-Graduação em Clínica Cirúrgica, Curitiba, PR, Brazil; Hospitais Vita, Serviço de Anestesiologia, Curitiba, PR, Brazil. Electronic address: gnuliana@hotmail.com.'}, {'ForeName': 'Elizabeth Milla', 'Initials': 'EM', 'LastName': 'Tambara', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Curitiba, PR, Brazil; Pontifícia Universidade Católica do Paraná, Escola de Medicina, Disciplina de Anestesiologia, Curitiba, PR, Brazil.'}, {'ForeName': 'Renato Tambara', 'Initials': 'RT', 'LastName': 'Filho', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Hospital de Clínicas, Curitiba, PR, Brazil.'}, {'ForeName': 'Giorgio Alfredo Pedroso', 'Initials': 'GAP', 'LastName': 'Baretta', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Curitiba, PR, Brazil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.03.004']
3389,32487236,"A randomized, crossover comparison of ketamine and electroconvulsive therapy for treatment of major depressive episodes: a Canadian biomarker integration network in depression (CAN-BIND) study protocol.","BACKGROUND
Recent evidence underscores the utility of rapid-acting antidepressant interventions, such as ketamine, in alleviating symptoms of major depressive episodes (MDE). However, to date, there have been limited head-to-head comparisons of intravenous (IV) ketamine infusions with other antidepressant treatment strategies in large randomized trials. This study protocol describes an ongoing multi-centre, prospective, randomized, crossover, non-inferiority trial comparing acute treatment of individuals meeting diagnostic criteria for a major depressive episode (MDE) with ketamine and electroconvulsive therapy (ECT) on efficacy, speed of therapeutic effects, side effects, and health care resource utilization. A secondary aim is to compare a 6-month maintenance strategy for ketamine responders to standard of care ECT maintenance. Finally, through the measurement of clinical, cognitive, neuroimaging, and molecular markers we aim to establish predictors and moderators of treatment response as well as treatment-elicited effects on these outcomes.
METHODS
Across four participating Canadian institutions, 240 patients with major depressive disorder or bipolar disorder experiencing a MDE are randomized (1:1) to a course of ECT or racemic IV ketamine (0.5 mg/kg) administered 3 times/week for 3 or 4 weeks. Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) crossover to receive the alternate treatment. Responders during the randomization or crossover phases then enter the 6-month maintenance phase during which time they receive clinical assessments at identical intervals regardless of treatment arm. ECT maintenance follows standard of care while ketamine maintenance involves: weekly infusions for 1 month, then bi-weekly infusions for 2 months, and finally monthly infusions for 3 months (returning to bi-weekly in case of relapse). The primary outcome measure is change in MADRS scores after randomized treatment as assessed by raters blind to treatment modality.
DISCUSSION
This multi-centre study will help identify molecular, imaging, and clinical characteristics of patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy. In addition to informing clinical practice and influencing health care delivery, this trial will add to the robust platform and database of CAN-BIND studies for future research and biomarker discovery.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT03674671. Registered September 17, 2018.",2020,Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores),"['individuals meeting diagnostic criteria for a major depressive episode (MDE) with', 'major depressive episodes', 'patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy', '240 patients with major depressive disorder or bipolar disorder experiencing a MDE']","['ketamine and electroconvulsive therapy', 'ketamine and electroconvulsive therapy (ECT', 'ketamine', 'ECT or racemic IV ketamine']","['Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'change in MADRS scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",240.0,0.221186,Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores),"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Jaworska', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kamler', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': 'Venkat', 'Initials': 'V', 'LastName': 'Bhat', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Blier', 'Affiliation': 'Montfort Hospital, 713 Montreal Rd, Ottawa, ON, K1K 0T2, Canada.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Foster', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hassel', 'Affiliation': 'Department of Psychiatry and Mathison Centre for Mental Health Research and Education, Cumming School of Medicine, University of Calgary, 3330 Hospital Dr NW, Calgary, AB, T2N 4N1, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Ho', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McMurray', 'Affiliation': 'Department of Psychiatry, University of Ottawa, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Milev', 'Affiliation': ""Department of Psychiatry, Queen's University, Providence Care Hospital, 752 King Street West, Postal Bag 603, Kingston, ON, K7L 7X3, Canada.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moazamigoudarzi', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Franca M', 'Initials': 'FM', 'LastName': 'Placenza', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Richard-Devantoy', 'Affiliation': 'McGill University, 845 Rue Sherbrooke O, Montréal, QC, H3A 0G4, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rotzinger', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Turecki', 'Affiliation': 'McGill University, 845 Rue Sherbrooke O, Montréal, QC, H3A 0G4, Canada.'}, {'ForeName': 'Gustavo H', 'Initials': 'GH', 'LastName': 'Vazquez', 'Affiliation': ""Department of Psychiatry, Queen's University, Providence Care Hospital, 752 King Street West, Postal Bag 603, Kingston, ON, K7L 7X3, Canada.""}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC psychiatry,['10.1186/s12888-020-02672-3']
3390,32487243,Immediate effects of a lumbar spine manipulation on pain sensitivity and postural control in individuals with nonspecific low back pain: a randomized controlled trial.,"BACKGROUND
According to the American Physical Therapy Association, there is strong evidence to show that vertebral mobilization and manipulation procedures can be used to improve spinal and hip mobility and reduce pain and incapacity in low back pain patients that fit the clinical prediction rule.
OBJECTIVES
To evaluate the immediate effects of high-velocity low-amplitude (HVLA) manipulation on pain and postural control parameters in individuals with nonspecific low back pain.
METHODS
This study used a participant-blinded and assessor-blinded randomized controlled clinical trial involving a single session, in which 24 participants were randomly distributed into control (simulated manipulation) and intervention (HVLA lumbar manipulation) groups. The primary (pain: subjective pain intensity and pressure pain threshold) and secondary outcomes (postural control: ellipse area, center of pressure [COP] excursion, COP RMS velocity, and differences between the COP and center of projected gravity) were evaluated before and after the session using a numerical pain scale, algometer, and a force platform. For all outcomes, multiple mixed 2 (group) × 2 (time) ANOVAs were performed.
RESULTS
For the subjective pain intensity, only time was significant as a main effect, where pre-intervention presented a greater value then post-intervention (F [1.44] = 4.377; p = 0.042; r = 0.30). For the pressure pain threshold no significant effect was found. For the postural control parameters, as a main effect, only the ellipse area was significantly greater in the control group (F [1.44] = 6.760; p = 0.013; effect size = 0.36).
CONCLUSIONS
There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure. No effect of HVLA lumbar manipulation was identified for postural control variables in either the intervention or control groups.
TRIAL REGISTRATION
The study was registered at ClinicalTrials.gov under the number NCT02312778, registered at 14 September 2014.",2020,"There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure.","['low back pain patients', '24 participants were randomly distributed into', 'individuals with nonspecific low back pain']","['high-velocity low-amplitude (HVLA) manipulation', 'HVLA lumbar manipulation', 'lumbar spine manipulation', 'control (simulated manipulation) and intervention (HVLA lumbar manipulation']","['pain sensitivity and postural control', 'pain and postural control parameters', 'subjective pain intensity', 'primary (pain: subjective pain intensity and pressure pain threshold) and secondary outcomes (postural control: ellipse area, center of pressure [COP] excursion, COP RMS velocity, and differences between the COP and center of projected gravity', 'numerical pain scale, algometer, and a force platform']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0600578', 'cui_str': 'Lumbar Manipulation'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",24.0,0.116324,"There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure.","[{'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Fagundes Loss', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil. jefferson.loss@ufrgs.br.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'de Souza da Silva', 'Affiliation': 'Instituto Brasileiro de Osteopatia, Porto Alegre, Brazil.'}, {'ForeName': 'Iã', 'Initials': 'I', 'LastName': 'Ferreira Miranda', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Groisman', 'Affiliation': 'Instituto Brasileiro de Osteopatia, Porto Alegre, Brazil.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Santiago Wagner Neto', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil.'}, {'ForeName': 'Catiane', 'Initials': 'C', 'LastName': 'Souza', 'Affiliation': 'Faculdade Social da Bahia, Salvador, Brazil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Tarragô Candotti', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00316-7']
3391,32487250,Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial.,"BACKGROUND
In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women's physical and mental health, IPV also increases the risk of child morbidity and mortality associated with maternal depression, thus making antenatal care an important opportunity for intervention. Adapting generic, task-shared, brief psychological interventions for perinatal depression and anxiety to address the needs and experiences of women affected by IPV may improve acceptability to women and feasibility for health workers. This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial.
METHODS
Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia. Consenting participants will be randomised to either four sessions of PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care) in a three-arm design. The interventions will be delivered by trained, supervised antenatal care staff using a task-sharing model. Assessments will be made at baseline and after 9 weeks by masked outcome assessors and will include measures of depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes). A mixed-method process evaluation will determine the feasibility of a future randomised controlled trial, assess the feasibility, acceptability, fidelity and quality of implementation of PST-IPV, generate testable hypotheses about causal mechanisms, and identify potential contextual factors influencing outcomes.
DISCUSSION
Despite mental health being a critical concern for women experiencing IPV, there is limited evidence for brief, task-shared psychological interventions adapted for their needs in low- and middle-income countries. Contextually tailored interventions for pregnant women experiencing IPV in low- and middle-income countries require development and process evaluation. This randomised controlled feasibility trial will yield results on the feasibility of conducting a fully powered trial, relevant to researchers, primary and antenatal care clinicians in resource-limited settings.
TRIAL REGISTRATION
Pan-African clinical trials registry: PACTR202002513482084. Prospectively registered on 13 December 2019.",2020,"This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial.
","['pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care', 'Consenting participants', 'pregnant women experiencing IPV in low- and middle-income countries', 'Prospectively registered on 13 December 2019', 'Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia', 'pregnant women experiencing IPV in rural Ethiopia']","['PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care', 'Problem solving therapy (PST', 'problem solving therapy (PST', 'standard PST']","['depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0205444', 'cui_str': 'Tenth'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",75.0,0.174148,"This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial.
","[{'ForeName': 'Roxanne C', 'Initials': 'RC', 'LastName': 'Keynejad', 'Affiliation': ""Section of Women's Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Tesera', 'Initials': 'T', 'LastName': 'Bitew', 'Affiliation': 'College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Sorsdahl', 'Affiliation': 'Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Alcohol Tobacco and Other Drug Use Research Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Honikman', 'Affiliation': 'Perinatal Mental Health Project, Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Girmay', 'Initials': 'G', 'LastName': 'Medhin', 'Affiliation': 'Aklilu-Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Negussie', 'Initials': 'N', 'LastName': 'Deyessa', 'Affiliation': 'College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Sevdalis', 'Affiliation': ""Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': ""Section of Women's Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. charlotte.hanlon@kcl.ac.uk.""}]",Trials,['10.1186/s13063-020-04331-0']
3392,32487263,Duration of antibiotic therapy in critically ill patients: a randomized controlled trial of a clinical and C-reactive protein-based protocol versus an evidence-based best practice strategy without biomarkers.,"BACKGROUND
The rational use of antibiotics is one of the main strategies to limit the development of bacterial resistance. We therefore sought to evaluate the effectiveness of a C-reactive protein-based protocol in reducing antibiotic treatment time in critically ill patients.
METHODS
A randomized, open-label, controlled clinical trial conducted in two intensive care units of a university hospital in Brazil. Critically ill infected adult patients were randomly allocated to (i) intervention to receive antibiotics guided by daily monitoring of CRP levels and (ii) control to receive antibiotics according to the best practices for rational use of antibiotics.
RESULTS
One hundred thirty patients were included in the CRP (n = 64) and control (n = 66) groups. In the intention-to-treat analysis, the median duration of antibiotic therapy for the index infectious episode was 7.0 (5.0-8.8) days in the CRP and 7.0 (7.0-11.3) days in the control (p = 0.011) groups. A significant difference in the treatment time between the two groups was identified in the curve of cumulative suspension of antibiotics, with less exposure in the CRP group only for the index infection episode (p = 0.007). In the per protocol analysis, involving 59 patients in each group, the median duration of antibiotic treatment was 6.0 (5.0-8.0) days for the CRP and 7.0 (7.0-10.0) days for the control (p = 0.011) groups. There was no between-group difference regarding the total days of antibiotic exposure and antibiotic-free days.
CONCLUSIONS
Daily monitoring of CRP levels may allow early interruption of antibiotic therapy in a higher proportion of patients, without an effect on total antibiotic consumption. The clinical and microbiological relevance of this finding remains to be demonstrated.
TRIAL REGISTRY
ClinicalTrials.gov Identifier: NCT02987790. Registered 09 December 2016.",2020,"A significant difference in the treatment time between the two groups was identified in the curve of cumulative suspension of antibiotics, with less exposure in the CRP group only for the index infection episode (p = 0.007).","['critically ill patients', 'two intensive care units of a university hospital in Brazil', 'Critically ill infected adult patients', 'One hundred thirty patients were included in the CRP (n\u2009=\u200964) and control (n\u2009=\u200966) groups']","['antibiotics guided by daily monitoring of CRP levels and (ii) control to receive antibiotics according to the best practices for rational use of antibiotics', 'C-reactive protein-based protocol', 'antibiotic therapy']","['median duration of antibiotic treatment', 'median duration of antibiotic therapy for the index infectious episode', 'total antibiotic consumption', 'curve of cumulative suspension of antibiotics', 'total days of antibiotic exposure and antibiotic-free days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",130.0,0.0993665,"A significant difference in the treatment time between the two groups was identified in the curve of cumulative suspension of antibiotics, with less exposure in the CRP group only for the index infection episode (p = 0.007).","[{'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Borges', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil. isabelanborges@gmail.com.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Carneiro', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Bergo', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Martins', 'Affiliation': 'Graduate Program in Statistics, Department of Statistics, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colosimo', 'Affiliation': 'Graduate Program in Statistics, Department of Statistics, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Oliveira', 'Affiliation': 'Graduate Program in Health Sciences: Adult Health, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Saturnino', 'Affiliation': 'Graduate Program in Health Sciences: Adult Health, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Marcus Vinícius', 'Initials': 'MV', 'LastName': 'Andrade', 'Affiliation': 'Graduate Program in Health Sciences: Adult Health, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Ravetti', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Vandack', 'Initials': 'V', 'LastName': 'Nobre', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-020-02946-y']
3393,32420624,Sensitivity analysis for subsequent treatments in confirmatory oncology clinical trials: A two-stage stochastic dynamic treatment regime approach.,"Subsequent treatments can result in a difficulty in interpretation of the overall survival results in confirmatory oncology clinical trials. To complement the intention-to-treat (ITT) analysis affected by subsequent treatment patterns unintentional in the trial protocol, several causal methods targeting the per-protocol effect have been proposed. When two or more types of subsequent treatments are allowed in the trial protocol, however, these methods cannot answer clinical questions such as how sensitive the ITT analysis result is to higher or lower proportions of each subsequent treatment allowed in the trial protocol than observed, and to what extent ITT analysis result is generalizable to subsequent treatment patterns other than observed one. To answer these clinical questions, we propose a sensitivity analysis method for subsequent treatments using the inverse probability of treatment weighting method for stochastic dynamic treatment regimes (DTRs). We formulate oncology clinical trials with subsequent treatments as two-stage designs in which initial treatments are randomized, but subsequent treatments are observational. In this formulation, we use stochastic DTRs to simulate specific proportions of each subsequent treatment and compare an initial experimental treatment with an initial control treatment under various proportions of each subsequent treatment. We applied our proposed method to a motivating randomized noninferiority trial for metastatic breast cancer. Simulation results are also reported to show the usefulness of the proposed method.",2020,"To answer these clinical questions, we propose a sensitivity analysis method for subsequent treatments using the inverse probability of treatment weighting method for stochastic dynamic treatment regimes (DTRs).",['metastatic breast cancer'],[],[],"[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]",[],[],,0.0949411,"To answer these clinical questions, we propose a sensitivity analysis method for subsequent treatments using the inverse probability of treatment weighting method for stochastic dynamic treatment regimes (DTRs).","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hagiwara', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Division of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.'}]",Biometrics,['10.1111/biom.13296']
3394,31752260,Exercise Mitigates the Loss of Muscle Mass by Attenuating the Activation of Autophagy during Severe Energy Deficit.,"The loss of skeletal muscle mass with energy deficit is thought to be due to protein breakdown by the autophagy-lysosome and the ubiquitin-proteasome systems. We studied the main signaling pathways through which exercise can attenuate the loss of muscle mass during severe energy deficit (5500 kcal/day). Overweight men followed four days of caloric restriction (3.2 kcal/kg body weight day) and prolonged exercise (45 min of one-arm cranking and 8 h walking/day), and three days of control diet and restricted exercise, with an intra-subject design including biopsies from muscles submitted to distinct exercise volumes. Gene expression and signaling data indicate that the main catabolic pathway activated during severe energy deficit in skeletal muscle is the autophagy-lysosome pathway, without apparent activation of the ubiquitin-proteasome pathway. Markers of autophagy induction and flux were reduced by exercise primarily in the muscle submitted to an exceptional exercise volume. Changes in signaling are associated with those in circulating cortisol, testosterone, cortisol/testosterone ratio, insulin, BCAA, and leucine. We conclude that exercise mitigates the loss of muscle mass by attenuating autophagy activation, blunting the phosphorylation of AMPK/ULK1/Beclin1, and leading to p62/SQSTM1 accumulation. This includes the possibility of inhibiting autophagy as a mechanism to counteract muscle loss in humans under severe energy deficit.",2019,Markers of autophagy induction and flux were reduced by exercise primarily in the muscle submitted to an exceptional exercise volume.,['Overweight men'],"['caloric restriction', 'prolonged exercise (45 min of one-arm cranking and 8 h walking/day), and three days of control diet and restricted exercise, with an intra-subject design including biopsies from muscles submitted to distinct exercise volumes']","['circulating cortisol, testosterone, cortisol/testosterone ratio, insulin, BCAA, and leucine', 'Loss of Muscle Mass']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",,0.0255296,Markers of autophagy induction and flux were reduced by exercise primarily in the muscle submitted to an exceptional exercise volume.,"[{'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Martin-Rincon', 'Affiliation': 'Department of Physical Education and Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Campus Universitario de Tafira, s/n, 35017 Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pérez-López', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, University of Alcalá, Ctra. Madrid-Barcelona, km 33,600, 28871 Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morales-Alamo', 'Affiliation': 'Department of Physical Education and Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Campus Universitario de Tafira, s/n, 35017 Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'Perez-Suarez', 'Affiliation': 'Department of Physical Education and Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Campus Universitario de Tafira, s/n, 35017 Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de Pablos-Velasco', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario de Gran Canaria Doctor Negrín, Calle Plaza Barranco de la Ballena, s/n, 35010 Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Perez-Valera', 'Affiliation': 'Department of Physical Education and Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Campus Universitario de Tafira, s/n, 35017 Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Perez-Regalado', 'Affiliation': 'Department of Physical Education and Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Campus Universitario de Tafira, s/n, 35017 Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Martinez-Canton', 'Affiliation': 'Department of Physical Education and Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Campus Universitario de Tafira, s/n, 35017 Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Gelabert-Rebato', 'Affiliation': 'Department of Physical Education and Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Campus Universitario de Tafira, s/n, 35017 Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Julian William', 'Initials': 'JW', 'LastName': 'Juan-Habib', 'Affiliation': 'Department of Physical Education and Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Campus Universitario de Tafira, s/n, 35017 Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Hans-Christer', 'Initials': 'HC', 'LastName': 'Holmberg', 'Affiliation': 'Department of Health Sciences, Mid Sweden University, SE-83140 Östersund, Sweden.'}, {'ForeName': 'Jose A L', 'Initials': 'JAL', 'LastName': 'Calbet', 'Affiliation': 'Department of Physical Education and Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Campus Universitario de Tafira, s/n, 35017 Las Palmas de Gran Canaria, Canary Islands, Spain.'}]",Nutrients,['10.3390/nu11112824']
3395,31779665,Biomechanical comparison of subscapularis peel and lesser tuberosity osteotomy for double-row subscapularis repair technique in a cadaveric arthroplasty model.,"INTRODUCTION
Management of the subscapularis during shoulder arthroplasty is controversial. The purpose of this study was to compare the biomechanical performance of subscapularis peel (SP) and lesser tuberosity osteotomy (LTO) in a cadaveric model.
METHODS
The subscapularis and proximal humerus were dissected from all soft tissues in 21 fresh-frozen human cadaveric shoulders and randomized to undergo SP, LTO, or standard subscapularis tenotomy (ST, control). For SP and LTO, six #5 sutures were passed through eyelets in the implant (on lateral border and through drill holes in bicipital groove [2] and under trunion [4]). Double-row repair was performed using two lateral row transosseous sutures and four medial row sutures through the tendon (SP) or osseotendinous junction (LTO). Biomechanical properties and mode of failure were tested.
RESULTS
There were no significant differences in elongation amplitude, cyclic elongation, or maximum load to failure between the three groups (P > 0.05). Mean stiffness was significantly higher in LTO (P = 0.009 vs. SP and ST). In the ST group, 7/7 specimens failed at the tendon-suture interface. For SP, 4/7 failed at the tendon-suture interface, one at the suture-bone interface, one fractured around the implant stem, and one at the knots. For LTO, 3/7 failed at the tendon-suture interface, two at the suture-bone interface and two fractured around the implant stem.
CONCLUSIONS
In this cadaveric model, subscapularis repair via ST, SP, and LTO techniques was biomechanically equivalent. Additional studies are needed to confirm these findings and determine the influence of biologic healing on healing rates and clinical outcomes.
LEVEL OF EVIDENCE
N/a, biomechanical laboratory study.",2019,"There were no significant differences in elongation amplitude, cyclic elongation, or maximum load to failure between the three groups (P > 0.05).",['cadaveric arthroplasty model'],"['Double-row repair was performed using two lateral row transosseous sutures and four medial row sutures through the tendon (SP) or osseotendinous junction (LTO', 'subscapularis peel (SP) and lesser tuberosity osteotomy (LTO', 'subscapularis peel and lesser tuberosity osteotomy for double-row subscapularis repair technique']","['elongation amplitude, cyclic elongation, or maximum load to failure', 'Mean stiffness']","[{'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0584884', 'cui_str': 'Subscapularis muscle structure'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0223687', 'cui_str': 'Structure of lesser tuberosity of humerus'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",,0.0355552,"There were no significant differences in elongation amplitude, cyclic elongation, or maximum load to failure between the three groups (P > 0.05).","[{'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Virk', 'Affiliation': 'Department of Orthopaedic Surgery, Division of Shoulder & Elbow, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Saleh S', 'Initials': 'SS', 'LastName': 'Aiyash', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, 1611 West Harrison Street, Suite 300, Chicago, IL, 60612, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Frank', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, 1611 West Harrison Street, Suite 300, Chicago, IL, 60612, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Mellano', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, 1611 West Harrison Street, Suite 300, Chicago, IL, 60612, USA.'}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Shewman', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, 1611 West Harrison Street, Suite 300, Chicago, IL, 60612, USA.'}, {'ForeName': 'Vincent M', 'Initials': 'VM', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, 1611 West Harrison Street, Suite 300, Chicago, IL, 60612, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Romeo', 'Affiliation': 'Rothman Orthopaedics- New York, 176 3rd Ave, New York, NY, 10003, USA. anthony.romeo@rothmanortho.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-019-1372-x']
3396,31833414,Pivotal Study of Endovenous Stent Placement for Symptomatic Iliofemoral Venous Obstruction.,"BACKGROUND
Chronic venous insufficiency is characterized by inadequate venous return from the lower extremities, which may arise from intravenous obstruction after deep vein thrombosis or from extrinsic venous compression. The purpose of this study was to determine the safety and effectiveness of a dedicated endovenous stent for symptomatic iliofemoral venous obstruction.
METHODS
The VIRTUS trial (VIRTUS Safety and Efficacy of the Veniti Vici Venous Stent System [Veniti, Inc] When Used to Treat Clinically Significant Chronic Non-Malignant Obstruction of the Iliofemoral Venous Segment) was a prospective, international, single-arm, pivotal study of endovenous stent placement in patients with symptomatic iliofemoral venous obstruction. Patients included those with ≥50% obstruction on venography and Clinical, Etiology, Anatomic, Pathophysiology clinical classification ≥3, or at least moderate leg pain with a Venous Clinical Severity Score of 2 or greater. All patients were treated with a self-expanding nitinol stent developed for dedicated use in the venous system (Vici Venous Stent System, Veniti, Inc/Boston Scientific, Marlborough, MA). Patients returned for clinical and imaging follow-up visits at 1 month, 6 months, and 1 year. The primary safety outcome was freedom from major adverse events at 30 days. The primary effectiveness outcome was venographic primary patency at 1-year. Adverse events were adjudicated by a Clinical Events Committee, and all imaging including venograms, intravascular ultrasound, and Doppler examinations were assessed by respective core laboratories.
RESULTS
Between March 2015 and November 2016, 170 patients (127 chronic post-thrombotic, mean age 54 years, 56.4% female) at 22 sites underwent endovenous stent placement. Mean diameter stenosis was 78%, with 31.2% total occlusions. Mean lesion length was 111.3 mm, range 10 to 260 mm (mean 125.3 mm for post-thrombotic patients and 70.2 mm for nonthrombotic patients). Freedom from a major adverse event through 30 days was 98.8%. The 1-year primary patency rate for the entire group was 84.0%. Venographic patency rates for the nonthrombotic and chronic post-thrombotic groups were 96.2% and 79.8%, respectively. At 12 months, 64% (85/132) of patients demonstrated at least a 3-point reduction in Venous Clinical Severity Score.
CONCLUSIONS
Twelve-month safety and effectiveness were demonstrated with the use of a dedicated venous stent to treat symptomatic iliofemoral venous obstructions, with reductions in clinical symptoms and improvements in quality of life, through 1-year follow-up.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02112877.",2019,"At 12 months, 64% (85/132) of patients demonstrated at least a 3-point reduction in Venous Clinical Severity Score.
","['Between March 2015 and November 2016, 170 patients (127 chronic post-thrombotic, mean age 54 years, 56.4% female) at 22 sites underwent', 'Symptomatic Iliofemoral Venous Obstruction', 'Patients included those with ≥50% obstruction on venography and Clinical, Etiology, Anatomic, Pathophysiology clinical classification ≥3, or at least moderate leg pain with a Venous Clinical Severity Score of 2 or greater', 'patients with symptomatic iliofemoral venous obstruction']","['self-expanding nitinol stent', 'endovenous stent placement', 'dedicated endovenous stent', 'Endovenous Stent Placement', 'Veniti Vici Venous Stent System [Veniti, Inc']","['safety and effectiveness', 'Mean lesion length', 'quality of life', 'Mean diameter stenosis', 'Venous Clinical Severity Score', 'Adverse events', '1-year primary patency rate', 'venographic primary patency at 1-year', 'Venographic patency rates', 'freedom from major adverse events']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C2919452', 'cui_str': 'Venous stent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.118756,"At 12 months, 64% (85/132) of patients demonstrated at least a 3-point reduction in Venous Clinical Severity Score.
","[{'ForeName': 'Mahmood K', 'Initials': 'MK', 'LastName': 'Razavi', 'Affiliation': 'Heart and Vascular Center, St Joseph Hospital, Orange, CA (M.K.R.).'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Black', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom (S.B.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gagne', 'Affiliation': 'Vascular Breakthroughs, Darien, CT (P.G.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Chiacchierini', 'Affiliation': 'R. P. Chiacchierini Consulting, Gaithersburg, MD (R.C.).'}, {'ForeName': 'Phillipe', 'Initials': 'P', 'LastName': 'Nicolini', 'Affiliation': 'Infirmerie Protestante de Lyon, France (P.N.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Marston', 'Affiliation': 'Division of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill (W.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008268']
3397,32482361,[Comparison of channelled videolaryngoscope and intubating laryngeal mask airway for tracheal intubation in obese patients: a randomised clinical trial].,"BACKGROUND
Obesity causes various difficulties in intubation and ventilation, which are confronted due to increased fat tissue in the upper airway and diminished compliance in the chest wall. Videolaryngoscopes and Intubating Laryngeal Mask Airway (ILMA) are good options as recommended by the American Society of Anesthesologists (ASA) difficult airway guidelines. We aimed to compare ILMA and Airtraq (a channeled videolaryngoscope) in obese patients.
METHODS
Eighty patients with ASA physical status I-III, aged between 18 and 65 years and with a body mass index greater than 35 kg.m -2 , who were undergoing elective surgery requiring orotracheal intubation, were included in the study. Patients were intubated with one of the devices cited.
RESULTS
There was no difference between the number of intubation attempts, insertion times and need for optimisation manoeuvres of Airtraq and ILMA. The intubation with Airtraq was accomplished in a shorter period of time than in that in the ILMA group (29.9±22.1s vs. 50.7±21.2s; p<0.001). A significant difference was found when the times of total intubation were compared (29.9±22.1s vs. 97.4±42.7s; p<0.001). The mean arterial pressure statistically increased after device insertion in the ILMA group (p<0.05).
CONCLUSIONS
Airtraq appears to be superior to ILMA in obese patients, with a total of time intubation of less than 60 seconds and with low mean arterial pressure changes. However, ILMA is still a useful tool that provides both ventilation and intubation throughout the whole intubation process.",2020,"There was no difference between the number of intubation attempts, insertion times and need for optimisation manoeuvres of Airtraq and ILMA.","['obese patients', 'Eighty patients with ASA physical status I-III, aged between 18 and 65 years and with a body mass index greater than 35 kg.m -2 , who were undergoing elective surgery requiring orotracheal intubation, were included in the study']","['channelled videolaryngoscope and intubating laryngeal mask airway for tracheal intubation', 'Videolaryngoscopes and Intubating Laryngeal Mask Airway (ILMA', 'ILMA and Airtraq (a channeled videolaryngoscope', 'ILMA']","['mean arterial pressure', 'number of intubation attempts, insertion times and need for optimisation manoeuvres of Airtraq and ILMA', 'times of total intubation']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",80.0,0.137797,"There was no difference between the number of intubation attempts, insertion times and need for optimisation manoeuvres of Airtraq and ILMA.","[{'ForeName': 'Canan Kamile', 'Initials': 'CK', 'LastName': 'Turna', 'Affiliation': 'Kocaeli University Medical Faculty, Anesthesiology and Reanimation, Kocaeli, Turkey.'}, {'ForeName': 'Zehra Ipek', 'Initials': 'ZI', 'LastName': 'Arslan', 'Affiliation': 'Kocaeli University Medical Faculty, Anesthesiology and Reanimation, Kocaeli, Turkey. Electronic address: zehraipek48@gmail.com.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Alparslan', 'Affiliation': 'Kocaeli University Medical Faculty, Anesthesiology and Reanimation, Kocaeli, Turkey.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Okyay', 'Affiliation': 'Kocaeli University Medical Faculty, Anesthesiology and Reanimation, Kocaeli, Turkey.'}, {'ForeName': 'Mine', 'Initials': 'M', 'LastName': 'Solak', 'Affiliation': 'Kocaeli University Medical Faculty, Anesthesiology and Reanimation, Kocaeli, Turkey.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.01.008']
3398,32482392,Early Cardiac and Cerebral Hemodynamics with Umbilical Cord Milking Compared with Delayed Cord Clamping in Infants Born Preterm.,"OBJECTIVE
To evaluate changes in cerebral oxygenation, peripheral arterial oxygenation, respiratory status, and administered fraction of inspired oxygen during the first 10 minutes of life in premature infants receiving umbilical cord milking compared with delayed cord clamping (DCC).
STUDY DESIGN
Premature infants born at 23 0/7 to 27 6/7 weeks of gestation were randomized to umbilical cord milking or DCC. A near infrared spectroscopy sensor, pulse oximeter, and electrocardiogram electrodes were placed. Pulse rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and fraction of inspired oxygen were collected for 10 minutes in the delivery room. Longitudinal models were used to compare effects of umbilical cord milking and DCC.
RESULTS
Fifty-six infants had cerebral oximetry and advanced monitoring at birth. There was an increased incidence of severe intraventricular hemorrhage in infants who received umbilical cord milking compared with DCC (P = .0211). Longitudinal models suggested that peripheral oxygen saturation was higher in the umbilical cord milking group in the first 4 minutes (P = .0221) and that mean airway pressures were lower in the umbilical cord milking group after the first 7 minutes (P = .0072). No statistical differences were observed for fraction of inspired oxygen, cerebral tissue oxygenation, or heart rates.
CONCLUSIONS
The data suggest that the rapid transfer of blood during umbilical cord milking may facilitate lung expansion with improved pulmonary blood flow, but may also increase cerebral blood flow, resulting in severe intraventricular hemorrhage.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03145142.",2020,There was an increased incidence of severe intraventricular hemorrhage in infants who received umbilical cord milking compared with DCC (P = .0211).,"['Infants Born Preterm', 'Fifty-six infants had cerebral oximetry and advanced monitoring at birth', 'premature infants receiving umbilical cord milking compared with delayed cord clamping (DCC', 'Premature infants born at 23 0/7 to 27 6/7 \xa0weeks of gestation']","['umbilical cord milking or DCC', 'Umbilical Cord Milking Compared with Delayed Cord Clamping']","['fraction of inspired oxygen, cerebral tissue oxygenation, or heart rates', 'mean airway pressures', 'cerebral oxygenation, peripheral arterial oxygenation, respiratory status, and administered fraction of inspired oxygen', 'peripheral oxygen saturation', 'cerebral blood flow', 'severe intraventricular hemorrhage', 'Pulse rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and fraction of inspired oxygen']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}]",56.0,0.151184,There was an increased incidence of severe intraventricular hemorrhage in infants who received umbilical cord milking compared with DCC (P = .0211).,"[{'ForeName': 'Anup C', 'Initials': 'AC', 'LastName': 'Katheria', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA. Electronic address: anup.katheria@sharp.com.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': 'Department of Biostatistics at the UAB School of Public Health, Birmingham, AL.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Essers', 'Affiliation': 'Department of Pediatrics University of Ulm, Ulm, Germany.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Mendler', 'Affiliation': 'Department of Pediatrics University of Ulm, Ulm, Germany.'}, {'ForeName': 'Eugene M', 'Initials': 'EM', 'LastName': 'Dempsey', 'Affiliation': 'Department of Pediatrics and INFANT Centre, University College Cork, Ireland.'}, {'ForeName': 'Georg M', 'Initials': 'GM', 'LastName': 'Schmölzer', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Arnell', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}, {'ForeName': 'Wade D', 'Initials': 'WD', 'LastName': 'Rich', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}, {'ForeName': 'Kasim', 'Initials': 'K', 'LastName': 'Hassen', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Allman', 'Affiliation': 'Department of Biostatistics at the UAB School of Public Health, Birmingham, AL.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, Salt Lake City, UT.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics at the UAB School of Public Health, Birmingham, AL.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Finer', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.010']
3399,32482433,Effects of Exercise and an Integrated Neuromuscular Inhibition Technique Program in the Management of Chronic Mechanical Neck Pain: A Randomized Controlled Trial.,"OBJECTIVE
The aim of this study was to evaluate the effect of adding the integrated neuromuscular inhibition technique (INIT) to therapeutic exercise (TE) in individuals with chronic mechanical neck pain (CMNP).
METHODS
In this 34-week, assessor-blind randomized controlled trial, 40 participants (men and women) with CMNP with active or latent myofascial trigger points on the neck muscles were divided into 2 groups. The participants followed 4 treatments per week for 10 weeks. The intervention group followed a TE program in combination with the INIT, whereas the control group followed the same program without the INIT. Both protocols were applied by physiotherapists. Pain, disability, pressure pain threshold, active range of motion, and health-related quality of life were evaluated before, during, and after the intervention, whereas patients were followed for 6 months after completion of treatment. Repeated-measures ANOVA was applied.
RESULTS
Both groups showed a significant improvement in all dependent measures after the intervention (P < .05). However, the intervention group showed greater improvement in the visual analog scale and neck disability index score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health Survey score, than the control group. In many of the above variables this improvement was seen from the second week and was maintained for 6 months after the intervention.
CONCLUSION
The results of this preliminary study suggest that the addition of the INIT to a TE program had a positive effect on pain, functionality, and the quality of life in individuals with CMNP.",2020,"However, the intervention group showed greater improvement in the visual analog scale and neck disability index score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health Survey score, than the control group.","['Chronic Mechanical Neck Pain', 'individuals with chronic mechanical neck pain (CMNP', '40 participants (men and women) with CMNP with active or latent myofascial trigger points on the neck muscles', 'individuals with CMNP']","['TE program in combination with the INIT, whereas the control group followed the same program without the INIT', 'integrated neuromuscular inhibition technique (INIT) to therapeutic exercise (TE', 'Exercise and an Integrated Neuromuscular Inhibition Technique Program']","['visual analog scale and neck disability index score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health Survey score', 'pain, functionality, and the quality of life', 'Pain, disability, pressure pain threshold, active range of motion, and health-related quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",40.0,0.0689753,"However, the intervention group showed greater improvement in the visual analog scale and neck disability index score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health Survey score, than the control group.","[{'ForeName': 'Dimitrios E', 'Initials': 'DE', 'LastName': 'Lytras', 'Affiliation': 'Laboratory of Ergophysiology, Department of Physical Education and Sports Sciences, Aristotle University of Thessaloniki, Thermi Thessaloniki, Greece. Electronic address: lytrasde@gmail.com.'}, {'ForeName': 'Evaggelos I', 'Initials': 'EI', 'LastName': 'Sykaras', 'Affiliation': 'Laboratory of Ergophysiology, Department of Physical Education and Sports Sciences, Aristotle University of Thessaloniki, Thermi Thessaloniki, Greece.'}, {'ForeName': 'Kosmas I', 'Initials': 'KI', 'LastName': 'Christoulas', 'Affiliation': 'Laboratory of Ergophysiology, Department of Physical Education and Sports Sciences, Aristotle University of Thessaloniki, Thermi Thessaloniki, Greece.'}, {'ForeName': 'Ioannis S', 'Initials': 'IS', 'LastName': 'Myrogiannis', 'Affiliation': 'Laboratory of Hygiene-Medical Statistics, School of Medicine, Aristotle University of Thessaloniki, University Campus, Thessaloniki, Greece.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Kellis', 'Affiliation': 'Laboratory of Neuromechanics, Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloníki, Agios Ioannis Serres, Greece.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.03.011']
3400,32482455,Does exercising before or after a meal affect energy balance in adolescents with obesity?,"BACKGROUND AND AIM
Exercise timing has been suggested to affect appetite and energy intake (EI). The aim of this study was to examine the impact of exercising immediately before or after a meal on EI, appetite sensations and food reward (FR) in adolescents with obesity.
METHODS AND RESULTS
Seventeen adolescents with obesity completed 3 experimental sessions (randomized controlled trial): rest + lunch (CON); exercise + lunch (EX-MEAL); lunch + exercise (MEAL-EX). The exercise consisted of cycling 30 min at 65%V̇O 2peak . Outcomes included ad libitum EI (weighed lunch and dinner), FR (Leeds Food Preference Questionnaire at pre- and post-combination of exercise/rest and lunch, and pre-dinner) and appetite sensations (visual analogue scales). EI was not different between conditions. Compared with CON, relative EI at lunch was lower in EX-MEAL and MEAL-EX (p ≤ 0.05) and daily only in MEAL-EX (p < 0.01). Postprandial fullness was higher in EX-MEAL compared to CON. Compared with CON, both EX-MEAL and MEAL-EX attenuated the increase in wanting for sweet food and reduced explicit liking for fat.
CONCLUSIONS
These preliminary results suggest that exercising immediately before or after a meal produce few differences in appetite and have small beneficial effects on overall energy balance in adolescents with obesity, as well as on FR.
CLINICAL TRIALS
NCT03967782.",2020,"Compared with CON, relative EI at lunch was lower in EX-MEAL and MEAL-EX (p ≤ 0.05) and daily only in MEAL-EX (p < 0.01).","['adolescents with obesity', 'Seventeen adolescents with obesity completed 3 experimental sessions (randomized controlled trial']","['rest\xa0+\xa0lunch (CON); exercise\xa0+\xa0lunch (EX-MEAL); lunch\xa0+\xa0exercise (MEAL-EX', 'CON, both EX-MEAL and MEAL-EX']","['Postprandial fullness', 'EI, appetite sensations and food reward (FR', 'wanting for sweet food and reduced explicit liking', 'overall energy balance', 'ad libitum EI (weighed lunch and dinner), FR (Leeds Food Preference Questionnaire at pre- and post-combination of exercise/rest and lunch, and pre-dinner) and appetite sensations (visual analogue scales', 'appetite and energy intake (EI']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453865', 'cui_str': 'Sweet food'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",17.0,0.0334859,"Compared with CON, relative EI at lunch was lower in EX-MEAL and MEAL-EX (p ≤ 0.05) and daily only in MEAL-EX (p < 0.01).","[{'ForeName': 'Fillon', 'Initials': 'F', 'LastName': 'Alicia', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; UGECAM Obesity Hospital, Clermont-Ferrand, France. Electronic address: fillonalicia@gmail.com.'}, {'ForeName': 'Beaulieu', 'Initials': 'B', 'LastName': 'Kristine', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Miguet', 'Initials': 'M', 'LastName': 'Maud', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Bailly', 'Initials': 'B', 'LastName': 'Mélina', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Finlayson', 'Initials': 'F', 'LastName': 'Graham', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Valérie', 'Affiliation': 'CHU, Clermont-Ferrand, France.'}, {'ForeName': 'Masurier', 'Initials': 'M', 'LastName': 'Julie', 'Affiliation': 'UGECAM Obesity Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Marie-Eve', 'Affiliation': 'Department of Kinesiology, University of Montreal, 2100 Edouard-Montpetit, Montreal, H3C 3J7, Canada; Sainte-Justine UHC Research Center, 5757 Decelles, Montreal, H3T 1C5, Canada.'}, {'ForeName': 'Pereira', 'Initials': 'P', 'LastName': 'Bruno', 'Affiliation': 'CHU, Biostatistics unit, Clermont-Ferrand, France.'}, {'ForeName': 'Duclos', 'Initials': 'D', 'LastName': 'Martine', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; CHU, Clermont-Ferrand, France.'}, {'ForeName': 'Boirie', 'Initials': 'B', 'LastName': 'Yves', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; CHU, Clermont-Ferrand, France.'}, {'ForeName': 'Thivel', 'Initials': 'T', 'LastName': 'David', 'Affiliation': 'Université Clermont Auvergne, AME2P, F-63000, Clermont-Ferrand, France; School of Psychology, University of Leeds, Leeds, UK.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.04.015']
3401,32482490,Pharmacokinetics of Inhaled Levodopa Administered With Oral Carbidopa in the Fed State in Patients With Parkinson's Disease.,"PURPOSE
Levodopa (LD) is the most effective oral pharmacotherapy for the management of motor symptoms in Parkinson's disease. However, LD use is complicated by a progressive shortening of the duration of efficacy of a dose, resulting in episodes of inadequate responsiveness, or OFF periods. OFF periods may also occur unpredictably, partly due to the pharmacokinetic (PK) variability of oral LD, resulting from gastrointestinal dysfunction and from the effects of food on absorption. CVT-301 is a levodopa inhalation powder for the treatment of OFF period symptoms in patients on oral dopa-decarboxylase inhibitor/LD. PK and safety profiles of single dose CVT-301, administered with oral carbidopa (CD) and oral CD/LD, were examined in patients with Parkinson's disease in the fed state.
METHODS
Eligible patients were aged 30-85 years, with a clinical diagnosis of Parkinson's disease and a body mass index of 18-32 kg/m 2 , and were receiving treatment with a stable regimen that included oral CD/LD (25/100 mg) (total LD, ≤800 mg/d). A high-fat/protein meal was eaten 4-5 h after the administration of the morning oral CD/LD dose. Blood samples for predose PK analysis were obtained after the meal, followed by a single inhaled dose of CVT-301 84 mg (+25 mg of oral CD) or oral CD/LD (25/100 mg) or vice versa in 2 dosing periods in a crossover design. Blood was sampled at 0, 5, 10, 15, 30, and 45 min and at 1, 1.5, 2, 3, and 4 h postdose. Tolerability assessments included treatment-emergent adverse events.
FINDINGS
Twenty-three patients were enrolled (65.2% male; 87.0% white; mean age, 69.3 years; mean body mass index, 26.9 kg/m 2 ; mean Parkinson's disease duration, 8.2 years; mean baseline LD dosage, 460.9 mg/d; 73.9% at Hoehn and Yahr stage <2.5). PK analyses were based on LD concentrations without baseline adjustment. Median T max values with CVT-301 and oral CD/LD were 15 and 120 min (P < 0.001). C max with CVT-301 was lower than with oral CD/LD (590.3 vs 844.3 ng/mL). C 10min and C 30min values with CVT-301 were approximately twice those with CD/LD (522.9 and 531.5 ng/mL vs 247.3 and 300.9 ng/mL, respectively). %CV for C 5min to C max with CVT-301 was lower than that with oral CD/LD. The most common treatment-emergent adverse event was cough (CVT-301, 7 patients [30.4%]; oral CD/LD, 1 patient [4.5%]).
IMPLICATIONS
PK properties showed that CVT-301 was more rapidly absorbed, with higher plasma LD concentrations in the first 45 min, and demonstrated lower interpatient variability, than was oral CD/LD in the fed condition. The study findings suggest that CVT-301 can be used without regard to food intake. ClinicalTrials.gov identifier: NCT03887884.",2020,C max with CVT-301 was lower than with oral CD/LD (590.3 vs 844.3 ,"[""Patients With Parkinson's Disease"", ""Twenty-three patients were enrolled (65.2% male; 87.0% white; mean age, 69.3 years; mean body mass index, 26.9\xa0kg/m 2 ; mean Parkinson's disease duration, 8.2 years; mean baseline LD dosage, 460.9\xa0mg/d; 73.9% at Hoehn and Yahr stage <2.5"", 'patients on oral dopa-decarboxylase inhibitor/LD', ""patients with Parkinson's disease in the fed state"", ""Eligible patients were aged 30-85 years, with a clinical diagnosis of Parkinson's disease and a body mass index of 18-32\xa0kg/m 2 , and were receiving treatment with a stable regimen that included oral CD/LD (25/100\xa0mg) (total LD, ≤800""]","['Levodopa (LD', 'CVT-301, administered with oral carbidopa (CD) and oral CD/LD', 'CVT-301 84\xa0mg (+25\xa0mg of oral CD) or oral CD/LD', 'CVT-301', 'oral CD/LD', 'Inhaled Levodopa Administered With Oral Carbidopa']","['C max with CVT-301', 'Median T max values with CVT-301 and oral CD/LD', 'Tolerability assessments included treatment-emergent adverse events', 'plasma LD concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0598272', 'cui_str': 'Dopa decarboxylase inhibitor'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0240912', 'cui_str': 'Congenital vertical talus'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0240912', 'cui_str': 'Congenital vertical talus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",23.0,0.0517237,C max with CVT-301 was lower than with oral CD/LD (590.3 vs 844.3 ,"[{'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Safirstein', 'Affiliation': 'MD Clinical, Hallandale Beach, FL, USA. Electronic address: bsafirstein@mdclinical.org.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ellenbogen', 'Affiliation': 'Quest Research Institute, Bingham Farms, MI, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Acorda Therapeutics, Inc, Ardsley, NY, USA.'}, {'ForeName': 'Herbert R', 'Initials': 'HR', 'LastName': 'Henney', 'Affiliation': 'Private Consultancy, West Grove, PA, USA.'}, {'ForeName': 'Deena M', 'Initials': 'DM', 'LastName': 'Kegler-Ebo', 'Affiliation': 'Acorda Therapeutics, Inc, Ardsley, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Acorda Therapeutics, Inc, Ardsley, NY, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.04.004']
3402,32482519,Effect of Calcium-Channel Blockade on the Cold-Induced Vasodilation Response.,"INTRODUCTION
Cold-induced vasodilation (CIVD) is seen in the extremities during exposure to cold. A strong vasodilation response has been associated with a decreased risk of cold injury. Increasing CIVD might further decrease this risk. The calcium-channel blocker nifedipine causes vasodilation and is used to treat Raynaud's syndrome and chilblains. Nifedipine is also used for high altitude pulmonary edema and could potentially serve a dual purpose in preventing frostbite. The effects of nifedipine on CIVD have not been studied.
METHODS
A double-blind crossover study comparing nifedipine (30 mg SR (sustained release) orally twice daily) to placebo was designed using 2 sessions of 4 finger immersion in 5°C water, with 24 h of medication pretreatment before each session. Finger temperatures were measured via nailbed thermocouples. The primary outcome was mean finger temperature; secondary outcomes were mean apex and nadir temperatures, first apex and nadir temperatures, subjective pain ranking, and time of vasodilation onset (all presented as mean±SD).
RESULTS
Twelve volunteers (age 29±3 [24-34] y) completed the study. No significant difference in finger temperature (9.2±1.1°C nifedipine vs 9.0±0.7°C placebo, P=0.38) or any secondary outcome was found. Pain levels were similar (2.8±1.6 nifedipine vs 3.0±1.5 placebo, P=0.32). The most common adverse event was headache (32% of nifedipine trials vs 8% placebo).
CONCLUSIONS
Pretreatment with 30 mg of oral nifedipine twice daily does not affect the CIVD response in healthy individuals under cold stress.",2020,"Pain levels were similar (2.8±1.6 nifedipine vs 3.0±1.5 placebo, P=0.32).","['Twelve volunteers (age 29±3', 'healthy individuals under cold stress']","['nifedipine', 'Nifedipine', 'calcium-channel blocker nifedipine', 'Calcium-Channel Blockade', 'Cold-induced vasodilation (CIVD', 'placebo']","['headache', 'finger temperature', 'CIVD response', 'mean finger temperature; secondary outcomes were mean apex and nadir temperatures, first apex and nadir temperatures, subjective pain ranking, and time of vasodilation onset (all presented as mean±SD', 'Finger temperatures', 'Pain levels', 'Cold-Induced Vasodilation Response']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4704948', 'cui_str': 'Cold Shock'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0006685', 'cui_str': 'Calcium Channel'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",12.0,0.224354,"Pain levels were similar (2.8±1.6 nifedipine vs 3.0±1.5 placebo, P=0.32).","[{'ForeName': 'Brendan H A', 'Initials': 'BHA', 'LastName': 'Milliner', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, Emergency Medicine, Salt Lake City, UT; University of Utah, Division of Emergency Medicine, Salt Lake City, UT. Electronic address: Brendan.milliner@gmail.com.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Brant-Zawadzki', 'Affiliation': 'University of Utah, Division of Emergency Medicine, Salt Lake City, UT.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'McIntosh', 'Affiliation': 'University of Utah, Division of Emergency Medicine, Salt Lake City, UT.'}]",Wilderness & environmental medicine,['10.1016/j.wem.2020.03.002']
3403,32482525,A Randomized Parallel Controlled Phase II Trial of Recombinant Human Endostatin Added to Neoadjuvant Chemotherapy for Stage III Breast Cancer.,"BACKGROUND
To explore the potential advantage of preoperative anti-angiogenosis therapy, we implemented a study to evaluate the efficacy of recombinant human endostatin (EN) in combination with neoadjuvant chemotherapy in the treatment of stage III breast cancer.
PATIENTS AND METHODS
Eighty-seven patients were randomized to neoadjuvant TEC (docetaxel, epirubicin, and cyclophosphamide) or to EN+TEC, followed by surgery. The primary endpoint was the objective response rate (ORR). Secondary endpoints included pathologic complete response (pCR), relapse-free survival (RFS), overall survival (OS), and safety.
RESULTS
Patients receiving EN+TEC achieved significantly higher ORR (81.82%; 36/44) compared with those receiving TEC (58.14%; 25/43; P=0.016). There was a non-significant trend of increased pCR with EN treatment (15.91% vs. 6.98%). The median follow-up was 54 months and revealed a significantly higher RFS with EN+TEC (median, 67.3 months; 95% confidence interval [CI], 61.0-73.7 months), compared with TEC (median, 55.0 months; 95% CI, 48.3-61.7 months; P =0.014). EN+TEC also significantly improved OS (74.2 months; 95% CI, 68.9-79.6 months), compared with TEC (59.1 months; 95% CI, 52.0-66.1 months; P =0 .006). The 3- and 5-year OS rates are estimated to be 88.5% and 82.8% with EN+TEC and 76.7% and 54.4% with TEC, respectively. Cox proportional regression analyses showed that EN+TEC was associated with improved OS (hazard ratio, 0.377; 95% CI, 0.418-0.959; P =0 .041). There was no significant difference in adverse events between EN+TEC and TEC.
CONCLUSION
The combination of EN+TEC neoadjuvant chemotherapy significantly improved the ORR and OS, suggesting a benefit of adding anti-angiogenesis to standard chemotherapy in the treatment of locally advanced breast cancer.",2020,"Cox proportional regression analyses showed that EN+TEC was associated with improved OS (hazard ratio, 0.377; 95% CI, 0.418-0.959; P =0","['locally advanced breast cancer', 'Stage III Breast Cancer', 'stage III breast cancer', 'Eighty-seven patients']","['neoadjuvant TEC (docetaxel, epirubicin, and cyclophosphamide) or to EN+TEC, followed by surgery', 'Recombinant Human Endostatin Added to Neoadjuvant Chemotherapy', 'recombinant human endostatin (EN', 'preoperative anti-angiogenosis therapy', 'neoadjuvant chemotherapy']","['OS', 'objective response rate (ORR', 'ORR and OS', 'ORR', '3- and 5-year OS rates', 'adverse events', 'pathologic complete response (pCR), relapse-free survival (RFS), overall survival (OS), and safety']","[{'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C4721421', 'cui_str': 'Breast cancer stage III'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0229951', 'cui_str': 'Thymic epithelial cell'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0534628', 'cui_str': 'Endostatin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",87.0,0.0599547,"Cox proportional regression analyses showed that EN+TEC was associated with improved OS (hazard ratio, 0.377; 95% CI, 0.418-0.959; P =0","[{'ForeName': 'Xiangmei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Research Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'OHSU-PSU School of Public Health, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Cao', 'Affiliation': 'Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Beichen', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Motomi', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Shiuh-Wen', 'Initials': 'SW', 'LastName': 'Luoh', 'Affiliation': 'Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Bergan', 'Affiliation': 'Division of Hematology/Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Yueping', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Pathology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Yunjiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. Electronic address: lyj818326@outlook.com.'}]",Clinical breast cancer,['10.1016/j.clbc.2020.04.009']
3404,31235380,Sex and Ethnic Differences in the Relationship between Changes in Anthropometric Measurements and Visceral Fat in Adolescents with Obesity.,"OBJECTIVE
To examine sex and ethnic differences in how baseline and changes in anthropometric measures relate with change in visceral fat with interventions in adolescents.
STUDY DESIGN
Black and white adolescents (n = 143: body mass index [BMI] ≥85th percentile, 12-18 years) who participated in intervention studies (3-6 months) were included and had assessments of anthropometric measures (weight, BMI, waist circumference, waist-to-hip ratio [WHR], and waist-to-thigh ratio) and visceral fat at L4-L5 by magnetic resonance imaging before and after interventions.
RESULTS
At baseline, all of the anthropometric measures were positively associated with visceral fat (P < .05), with weight, waist circumference, and WHR having the largest variance explained (model adjusted R 2 = 0.35-0.47 vs 0.32-0.35). Blacks had 11.5-23.3 cm 2 less visceral fat compared with whites for a given anthropometric value. Girls tended to have less visceral fat for a given anthropometric value, but the sex differences were not consistently significant (range: 0.7-12.9 cm 2 ). Changes in waist circumference, BMI, and weight, but not WHR, remained significantly associated with changes in visceral fat. There were no sex differences, and much more minimal ethnic differences (<4.9 cm 2 ).
CONCLUSIONS
At baseline, there are sex and ethnic differences in how anthropometric measures correlate with visceral fat. However, there were minimal sex and ethnic differences in how changes in anthropometric measures related with changes in visceral fat. Although all of the anthropometric measures were associated with visceral fat at baseline, waist circumference, BMI, and weight, but not WHR were associated with changes in visceral fat.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT00739180, NCT01323088, and NCT01938950.",2019,"At baseline, all of the anthropometric measures were positively associated with visceral fat (P < .05), with weight, waist circumference, and WHR having the largest variance explained (model adjusted R 2 = ","['Black and white adolescents (n\xa0', 'adolescents', 'Adolescents with Obesity', '12-18\xa0years) who participated in intervention studies (3-6\xa0months) were included and had assessments of anthropometric measures (weight, BMI, waist circumference, waist-to-hip ratio [WHR], and waist-to-thigh ratio) and visceral fat at L4-L5 by magnetic resonance imaging before and after interventions', '143']",[],"['visceral fat at baseline, waist circumference, BMI, and weight', 'waist circumference, BMI, and weight, but not WHR', 'visceral fat']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332314', 'cui_str': 'Has assessment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517573', 'cui_str': '143'}]",[],"[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.0221463,"At baseline, all of the anthropometric measures were positively associated with visceral fat (P < .05), with weight, waist circumference, and WHR having the largest variance explained (model adjusted R 2 = ","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kuk', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'SoJung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Sports Medicine, Graduate School of Physical Education, Kyung Hee University, Yongin, Republic of Korea. Electronic address: sojung.lee@khu.ac.kr.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.05.052']
3405,31623766,Individualizing Revascularization Strategy for Diabetic Patients With Multivessel Coronary Disease.,"BACKGROUND
In patients with diabetes and multivessel coronary artery disease (CAD), the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that, on average, coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) for major acute cardiovascular events (MACE) and angina reduction. Nonetheless, multivessel PCI remains a common revascularization strategy in the real world.
OBJECTIVES
To translate the results of FREEDOM to individual patients in clinical practice, risk models of the heterogeneity of treatment benefit were built.
METHODS
Using patient-level data from 1,900 FREEDOM patients, the authors developed models to predict 5-year MACE (all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke) and 1-year angina after CABG and PCI using baseline covariates and treatment interactions. Parsimonious models were created to support clinical use. The models were internally validated using bootstrap resampling, and the MACE model was externally validated in a large real-world registry.
RESULTS
The 5-year MACE occurred in 346 (18.2%) patients, and 310 (16.3%) had angina at 1 year. The MACE model included 8 variables and treatment interactions with smoking status (c = 0.67). External validation in stable CAD (c = 0.65) and ACS (c = 0.68) demonstrated comparable performance. The 6-variable angina model included a treatment interaction with SYNTAX score (c = 0.67). PCI was never superior to CABG, and CABG was superior to PCI for MACE in 54.5% of patients and in 100% of patients with history of smoking.
CONCLUSIONS
To help disseminate the results of FREEDOM, the authors created a personalized risk prediction tool for patients with diabetes and multivessel CAD that could be used in shared decision-making for CABG versus PCI by estimating each patient's personal outcomes with both treatments.",2019,"PCI was never superior to CABG, and CABG was superior to PCI for MACE in 54.5% of patients and in 100% of patients with history of smoking.
","['Patients with Diabetes Mellitus', 'patients with diabetes and multivessel coronary artery disease (CAD', 'patients with diabetes and multivessel CAD', 'Diabetic Patients']","['percutaneous coronary intervention (PCI', 'coronary artery bypass grafting (CABG']","['5-year MACE (all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke) and 1-year angina after CABG and PCI', '5-year MACE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",,0.0173124,"PCI was never superior to CABG, and CABG was superior to PCI for MACE in 54.5% of patients and in 100% of patients with history of smoking.
","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Qintar', 'Affiliation': ""Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City, Missouri. Electronic address: qintarm@umkc.edu.""}, {'ForeName': 'Karin H', 'Initials': 'KH', 'LastName': 'Humphries', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Suzanne V', 'Initials': 'SV', 'LastName': 'Arnold', 'Affiliation': ""Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City, Missouri.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City, Missouri.""}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Jones', 'Affiliation': ""Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City, Missouri.""}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Salisbury', 'Affiliation': ""Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City, Missouri.""}, {'ForeName': 'Faraz', 'Initials': 'F', 'LastName': 'Kureshi', 'Affiliation': ""Austin Heart, St. David's Heart and Vascular, Austin, Texas; National Institutes of Health, National Heart, Lung, and Blood Institute, Bethesda, Maryland.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Zena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City, Missouri.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City, Missouri.""}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.083']
3406,31636023,Cortical modulation of nociception by galvanic vestibular stimulation: A potential clinical tool?,"OBJECTIVE
Vestibular afferents converge with nociceptive ones within the posterior insula, and can therefore modulate nociception. Consistent with this hypothesis, caloric vestibular stimulation (CVS) has been shown to reduce experimental and clinical pain. Since CVS can induce undesirable effects in a proportion of patients, here we explored an alternative means to activate non-invasively the vestibular pathways using innocuous bi-mastoid galvanic stimulation (GVS), and assessed its effects on experimental pain.
METHODS
Sixteen healthy volunteers participated in this study. Experimental pain was induced by noxious laser-heat stimuli to the left hand while recording pain ratings and related brain potentials (LEPs). We evaluated changes of these indices during left- or right-anodal GVS (cathode on contralateral mastoid), and contrasted them with those during sham GVS, optokinetic vestibular stimulation (OKS) using virtual reality, and attentional distraction to ascertain the vestibular-specific analgesic effects of GVS.
RESULTS
GVS elicited brief sensations of head/trunk deviation, inoffensive to all participants. Both active GVS conditions showed analgesic effects, greater for the right anodal stimulation. OKS was helpful to attain significant LEP reductions during the left-anodal stimulation. Neither sham-GVS nor the distraction task were able to modulate significantly pain ratings or LEPs.
CONCLUSIONS
GVS appeared as a well-tolerated and powerful procedure for the relief of experimental pain, probably through physiological interaction within insular nociceptive networks. Either isolated or in combination with other types of vestibular activation (e.g., optokinetic stimuli), GVS deserves being tested in clinical settings.",2020,"Neither sham-GVS nor the distraction task were able to modulate significantly pain ratings or LEPs.
",['Sixteen healthy volunteers participated in this study'],"['caloric vestibular stimulation (CVS', 'galvanic vestibular stimulation', 'left- or right-anodal GVS (cathode on contralateral mastoid), and contrasted them with those during sham GVS, optokinetic vestibular stimulation (OKS) using virtual reality, and attentional distraction']","['pain ratings and related brain potentials (LEPs', 'pain ratings or LEPs', 'LEP reductions', 'analgesic effects']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0446908', 'cui_str': 'Mastoid structure'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",16.0,0.0258073,"Neither sham-GVS nor the distraction task were able to modulate significantly pain ratings or LEPs.
","[{'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Central Integration of Pain (NeuroPain), Lab-Lyon Neuroscience Research Center, INSERM U1028, CNRS, UMR5292, Université Claude Bernard, Bron, F-69677, France. Electronic address: hagiwara-kyu@umin.ac.jp.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Perchet', 'Affiliation': 'Central Integration of Pain (NeuroPain), Lab-Lyon Neuroscience Research Center, INSERM U1028, CNRS, UMR5292, Université Claude Bernard, Bron, F-69677, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Frot', 'Affiliation': 'Central Integration of Pain (NeuroPain), Lab-Lyon Neuroscience Research Center, INSERM U1028, CNRS, UMR5292, Université Claude Bernard, Bron, F-69677, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Bastuji', 'Affiliation': ""Central Integration of Pain (NeuroPain), Lab-Lyon Neuroscience Research Center, INSERM U1028, CNRS, UMR5292, Université Claude Bernard, Bron, F-69677, France; Service de Neurologie Fonctionnelle et D'Épileptologie et Centre Du Sommeil, Hospices Civils de Lyon, Bron, F-69677, France.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Larrea', 'Affiliation': ""Central Integration of Pain (NeuroPain), Lab-Lyon Neuroscience Research Center, INSERM U1028, CNRS, UMR5292, Université Claude Bernard, Bron, F-69677, France; Centre D'évaluation et de Traitement de La Douleur, Hôpital Neurologique, Lyon, F-69000, France.""}]",Brain stimulation,['10.1016/j.brs.2019.10.009']
3407,31682976,The influence of gastric motility on the intraluminal behavior of fosamprenavir.,"In fasting conditions, the gastrointestinal system contracts according to the interdigestive migrating motor complex (MMC), in which phases of quiescence (MMC phase I) alternate with phases of medium (MMC phase II) to very strong (MMC phase III) contractions. The time of drug intake relative to this cyclic motility pattern may cause variations in formulation behavior. To explore this hypothesis, a cross-over study was performed in healthy volunteers with an immediate release tablet of fosamprenavir (Telzir) which was administered in either MMC phase I or MMC phase II, as determined by high-resolution manometry. In the intestinal tract, fosamprenavir is rapidly hydrolyzed to the active compound amprenavir by alkaline phosphatases. Drug concentrations of both prodrug and drug were determined in the stomach and duodenum and linked to simultaneously assessed systemic concentrations. In 5 out of 6 healthy volunteers, the gastric release of fosamprenavir and the systemic uptake of amprenavir were affected by the MMC phase in which the tablet was administered. The intragastric disintegration of the tablet was faster and less variable after administration in MMC phase II, resulting in faster and less variable uptake of amprenavir in the systemic circulation. Mean plasma t max values were 157 (±72.0) and 73.3 (±27.3) min after administration in MMC phase I and MMC phase II, respectively. The study clearly identified the time of oral drug intake relative to the interdigestive motility pattern as a possible source of variation in gastrointestinal drug behavior and absorption.",2020,"The intragastric disintegration of the tablet was faster and less variable after administration in MMC phase II, resulting in faster and less variable uptake of amprenavir in the systemic circulation.","['healthy volunteers with an immediate release tablet of', '6 healthy volunteers']","['fosamprenavir', 'amprenavir', 'fosamprenavir (Telzir']","['intragastric disintegration', 'gastric release of fosamprenavir and the systemic uptake of amprenavir', 'Mean plasma t max values']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C1176315', 'cui_str': 'fosamprenavir'}, {'cui': 'C0754188', 'cui_str': 'Amprenavir'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1176315', 'cui_str': 'fosamprenavir'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0754188', 'cui_str': 'Amprenavir'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",6.0,0.017909,"The intragastric disintegration of the tablet was faster and less variable after administration in MMC phase II, resulting in faster and less variable uptake of amprenavir in the systemic circulation.","[{'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Braeckmans', 'Affiliation': 'Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Herestraat 49 - Box 921, 3000 Leuven, Belgium. Electronic address: marlies.braeckmans@kuleuven.be.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Brouwers', 'Affiliation': 'Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Herestraat 49 - Box 921, 3000 Leuven, Belgium. Electronic address: joachim.brouwers@kuleuven.be.'}, {'ForeName': 'Imke', 'Initials': 'I', 'LastName': 'Masuy', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, TARGID, KU Leuven, Herestraat 49, 3000 Leuven, Belgium. Electronic address: imke.masuy@kuleuven.be.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Servais', 'Affiliation': 'Galephar M/F Research Center, 6900 Marche-en-Famenne, Belgium. Electronic address: cserv@galephar.be.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders, TARGID, KU Leuven, Herestraat 49, 3000 Leuven, Belgium. Electronic address: jan.tack@kuleuven.be.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Augustijns', 'Affiliation': 'Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Herestraat 49 - Box 921, 3000 Leuven, Belgium. Electronic address: patrick.augustijns@kuleuven.be.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2019.105117']
3408,30624003,Comparison of Paresthesia Coverage of Patient's Pain: Dorsal Root Ganglion vs. Spinal Cord Stimulation. An ACCURATE Study Sub-Analysis.,"OBJECTIVES
This was a sub-analysis of the ACCURATE clinical trial that evaluated the accuracy and necessity of targeting paresthesia coverage of painful areas with dorsal root ganglion (DRG) stimulation vs. tonic spinal cord stimulation (SCS).
MATERIALS AND METHODS
On diagrams of the torso and lower limbs, subjects marked where they felt pain at baseline and paresthesias at three months postimplant. Seventy-five subjects (41 DRG and 34 SCS) with diagrams of sufficient quality were scanned, digitized, and included in this analysis. Subject completed diagrams were digitized and superimposed with a grid of 1398 squares. Quantification of the percentage of bodily areas affected by pain and stimulation induced paresthesias was performed.
RESULTS
The percent of painful areas covered by paresthesia was significantly lower for DRG subjects than for SCS subjects (13% vs. 28% of the painful regions, p < 0.05), possibly because significantly more DRG subjects felt no paresthesia during stimulation when compared to SCS subjects (13/41 DRG vs. 3/34 SCS) (p < 0.05). The amount of paresthesia produced outside the painful areas (unrequired paresthesia) was significantly lower in DRG subjects than that of SCS subjects. On average, the percent of unrequired paresthesia was only 20% of the subjects' total painful body surface area in the DRG group compared to 210% in the SCS group (p < 0.01).
CONCLUSIONS
The results of this ACCURATE study sub-analysis show that DRG stimulation produces paresthesias, on average, that are less frequent, less intense, with a smaller footprint on the body and less dependent on positional changes.",2019,The amount of paresthesia produced outside the painful areas (unrequired paresthesia) was significantly lower in DRG subjects than that of SCS subjects.,"[""Patient's Pain"", 'Seventy-five subjects (41 DRG and 34 SCS) with diagrams of sufficient quality']",['dorsal root ganglion (DRG) stimulation vs. tonic spinal cord stimulation (SCS'],"['unrequired paresthesia', 'percent of painful areas covered by paresthesia', 'total painful body surface area']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]","[{'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]",1398.0,0.0270257,The amount of paresthesia produced outside the painful areas (unrequired paresthesia) was significantly lower in DRG subjects than that of SCS subjects.,"[{'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Deer', 'Affiliation': 'Center for Pain Relief, Charleston, WV, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Levy', 'Affiliation': 'Neuromodulation Institute, Boca Raton, FL, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Kramer', 'Affiliation': 'Volta Research, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Poree', 'Affiliation': 'University of California at San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Amirdelfan', 'Affiliation': 'IPM Medical Group, Inc., Walnut Creek, CA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Grigsby', 'Affiliation': 'Neurovations, Napa, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Staats', 'Affiliation': 'Premier Pain Center, Shrewsbury Township, NJ, USA.'}, {'ForeName': 'Abram H', 'Initials': 'AH', 'LastName': 'Burgher', 'Affiliation': 'HOPE Research - TPC, Phoenix, AZ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scowcroft', 'Affiliation': 'Pain Management Associates, Independence, MO, USA.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Golovac', 'Affiliation': 'Florida Pain, Merritt Island, FL, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, NC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Paicius', 'Affiliation': 'Newport Beach Headache and Pain, Newport Beach, CA, USA.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Pope', 'Affiliation': 'Evolve Restorative Center, Santa Rosa, CA, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Samuel', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Porter McRoberts', 'Affiliation': 'Holy Cross Hospital, Ft. Lauderdale, FL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schaufele', 'Affiliation': 'Drug Studies America, Marietta, GA, USA.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Burton', 'Affiliation': 'Abbott Neuromodulation, Plano, TX, USA.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Raza', 'Affiliation': 'Abbott Neuromodulation, Plano, TX, USA.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Agnesi', 'Affiliation': 'Abbott Neuromodulation, Plano, TX, USA.'}, {'ForeName': 'Nagy', 'Initials': 'N', 'LastName': 'Mekhail', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.12920']
3409,30791804,"Safety and tolerability of sifalimumab, an anti-interferon-α monoclonal antibody, in Japanese patients with systemic lupus erythematosus: A multicenter, phase 2, open-label study.","Objectives: To evaluate the safety of sifalimumab in Japanese patients with systemic lupus erythematosus (SLE). Methods: This phase 2, open-label study consisted of a 52-week initial stage (Stage I) and a long-term extension (Stage II). In Stage I, sequential cohorts of patients received ascending doses of sifalimumab (intravenous [IV] 1.0, 3.0, and 10.0 mg/kg or subcutaneous 100 mg every 2 weeks; IV 600 and 1200 mg every 6 weeks). In Stage II, patients enrolled before June 2012 received the same dose of sifalimumab as during Stage I for up to 157 weeks or sifalimumab 600 mg IV every 4 weeks if they enrolled later. The safety of sifalimumab was assessed by adverse events (AEs). Results: Thirty patients enrolled in Stage I and 21 patients entered Stage II. The majority of patients experienced AEs (96.7% in Stage I and 100% in Stage II); most were mild or moderate in severity. Serious AEs occurred in 30.0% and 57.1% of patients in Stage I and II, respectively; most were instances of SLE flares. The proportion of patients in Stage I and II who had AEs leading to discontinuation was 10.0% and 28.6%, respectively. Conclusion: Sifalimumab was well tolerated in Japanese patients with SLE.",2020,The majority of patients experienced AEs (96.7% in Stage I and 100% in Stage II); most were mild or moderate in severity.,"['Thirty patients enrolled in Stage I and 21 patients entered Stage II', 'Japanese patients with systemic lupus erythematosus (SLE', 'Japanese patients with systemic lupus erythematosus', 'Japanese patients with SLE']","['Sifalimumab', 'sifalimumab']","['Serious AEs', 'Safety and tolerability']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C2986882', 'cui_str': 'sifalimumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.0980954,The majority of patients experienced AEs (96.7% in Stage I and 100% in Stage II); most were mild or moderate in severity.,"[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.'}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Matsumura', 'Affiliation': 'Department of Allergy, National Hospital Organization, Chiba-East Hospital, Chiba, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Internal Medicine, National Hospital Organization, Kanazawa Medical Center, Ishikawa, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Amano', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Hokkaido University Hospital, Hokkaido, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Suematsu', 'Affiliation': 'Department of Internal Medicine and Rheumatology, National Hospital Organization, Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Department of Research and Development, AstraZeneca K.K, Osaka, Japan.'}, {'ForeName': 'Liangwei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Tummala', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",Modern rheumatology,['10.1080/14397595.2019.1583832']
3410,32482112,Effects of anti-osteoporosis therapy on plasma aldosterone and renin.,"OBJECTIVE
This study aimed to investigate the effect of anti-osteoporosis therapy on plasma aldosterone concentration (PAC), plasma renin concentration (PRC) and the aldosterone/renin ratio (ARR) in patients with postmenopausal osteoporosis.
METHODS
In 60 patients with postmenopausal osteoporosis, bone mineral density (BMD), PAC and PRC were measured before and after treatment with alendronate (70 mg/week, n =22) or recombinant human parathyroid hormone (20 μg/day, n =35) for 48 weeks.
RESULTS
PAC was negatively correlated with the T-score of lumbar spine BMD and femoral neck BMD (lumbar r =-0.386, p <0.01; femoral neck r =-0.262, p <0.05). With the improvement in lumbar BMD after anti-osteoporosis treatment (T-score -3.4±0.5 vs. -3.1 ±0.4, p <0.0001), PAC decreased from 182.8±53.2 to 143.7±68.6 pg/mL ( p <0.0001), PRC increased from 7.8±11.6 to 39.2±50.0 μIU/mL ( p <0.0001) and the ARR decreased from 74.8±75.2 to 13.1±17.1 pg/μIU ( p <0.0001). At baseline, 58% (35/60) of the patients had an ARR >37 pg/μIU, and the proportion decreased to 8% (5/57) after treatment.
CONCLUSION
Treatment with alendronate or parathyroid hormone causes decreased PAC and increased PRC, resulting in a decreased ARR in postmenopausal women with osteoporosis.",2020,"RESULTS
PAC was negatively correlated with the T-score of lumbar spine BMD and femoral neck BMD (lumbar r","['patients with postmenopausal osteoporosis', 'postmenopausal women with osteoporosis', '60 patients with postmenopausal osteoporosis']","['anti-osteoporosis therapy', 'recombinant human parathyroid hormone', 'alendronate', 'alendronate or parathyroid hormone']","['bone mineral density (BMD), PAC and PRC', 'plasma aldosterone concentration (PAC), plasma renin concentration (PRC) and the aldosterone/renin ratio (ARR', 'T-score of lumbar spine BMD and femoral neck BMD (lumbar r', 'lumbar BMD', 'PRC', 'plasma aldosterone and renin', 'ARR', 'PAC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}]",60.0,0.0845602,"RESULTS
PAC was negatively correlated with the T-score of lumbar spine BMD and femoral neck BMD (lumbar r","[{'ForeName': 'Qingfen', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': ""Department of Endocrinology, the People's Hospital of Kaizhou District, PR China.""}, {'ForeName': 'Kangla', 'Initials': 'K', 'LastName': 'Liao', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Chongqing Medical University, PR China.'}, {'ForeName': 'Longwei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, the People's Hospital of Kaizhou District, PR China.""}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'Department of Endocrinology, the Affiliated Hospital of Guizhou Medical University, PR China.'}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University, PR China.'}, {'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ""Department of Endocrinology, the People's Hospital of Kaizhou District, PR China.""}, {'ForeName': 'Qifu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University, PR China.'}, {'ForeName': 'Shumin', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University, PR China.'}]",Journal of the renin-angiotensin-aldosterone system : JRAAS,['10.1177/1470320320928874']
3411,32482120,Perceived Patient Pain and Spousal Caregivers' Negative Affect: The Moderating Role of Spouse Confidence in Patients' Pain Management.,"Objectives: This study examined whether older patients' greater daily pain perceived by their spouses was associated with spouses' higher daily negative affect. We further investigated whether spouses' lower confidence in patients' ability to manage pain exacerbated the daily association between perceived patient pain and spouses' negative affect. Method: We used baseline interviews and a 22-day diary of knee osteoarthritis patients and their spouses ( N = 144 couples). Multilevel models were estimated to test hypotheses. Results: Daily perceived patient pain was not associated with spouses' daily negative affect. However, spouse confidence significantly moderated the association. Only spouses with lower confidence in patients' pain management experienced higher negative affect on days when they perceived that patients' level of pain was higher than usual. Discussion: Findings suggest that spousal caregivers' lack of confidence in patients' pain management may be a risk factor for spouses' affective distress in daily life.",2020,Only spouses with lower confidence in patients' pain management experienced higher negative affect on days when they perceived that patients' level of pain was higher than usual. ,"['knee osteoarthritis patients and their spouses ( N = 144 couples', ""Patients' Pain Management"", 'older patients']",[],"['patient pain', 'level of pain', 'greater daily pain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",144.0,0.0426678,Only spouses with lower confidence in patients' pain management experienced higher negative affect on days when they perceived that patients' level of pain was higher than usual. ,"[{'ForeName': 'Suyoung', 'Initials': 'S', 'LastName': 'Nah', 'Affiliation': 'The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Martire', 'Affiliation': 'The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Ruixue', 'Initials': 'R', 'LastName': 'Zhaoyang', 'Affiliation': 'The Pennsylvania State University, University Park, Pennsylvania.'}]",Journal of aging and health,['10.1177/0898264320919631']
3412,31239328,An international multicenter retrospective study to survey the landscape of thrombectomy in the treatment of anterior circulation acute ischemic stroke: outcomes with respect to age.,"BACKGROUND
Thrombectomy is an efficacious treatment for acute ischemic stroke (AIS). However, relatively few studies to date have specifically examined the impact and clinical implications of age on outcomes for thrombectomy in anterior AIS.
OBJECTIVE
To provide a snapshot of patient metrics and outcomes with respect to age following thrombectomy for anterior AIS to supplement the current body of data for predictors of clinical outcomes in a real-world setting.
METHODS
Data were collected for 20 consecutive patients with AIS treated with thrombectomy at 15 high-volume stroke centers across North America between 2015 and 2016. Patients with anterior occlusions were dichotomized based on whether they were older or younger than 80 years. Ordinal logistic regression analyzed how clinical variables impacted disability using 90-day modified Rankin Scale (mRS) scores.
RESULTS
Adequate revascularization (TICI ≥2B) was achieved in 92.3% of patients aged <80 years with an average 1.7±0.1 passes taken with the primary technique and in 88.0% of patients aged ≥80 years with an average 1.7±0.2 passes. Despite similar baseline characteristics, mRS scores were significantly higher in older patients postoperatively and at 90 days after intervention. Age was a significant predictor of 90-day mRS across the study population.
CONCLUSION
This analysis affirms age is a significant determinant of 90-day mRS scores following thrombectomy for large vessel anterior AIS. Further investigation into risks faced by elderly patients during thrombectomy may provide actionable information to help refine patient selection and improve outcomes.",2020,Adequate revascularization (TICI ≥2B) was achieved in 92.3% of patients aged <80 years with an average 1.7±0.1 passes taken with the primary technique and in 88.0% of patients aged ≥80 years with an average 1.7±0.2 passes.,"['Patients with anterior occlusions were dichotomized based on whether they were older or younger than 80 years', '20 consecutive patients with AIS treated with thrombectomy at 15 high-volume stroke centers across North America between 2015 and 2016', 'anterior circulation acute ischemic stroke', 'elderly patients', 'acute ischemic stroke (AIS']",[],"['90-day mRS scores', '90-day modified Rankin Scale (mRS) scores', 'mRS scores', 'Adequate revascularization (TICI ≥2B', '90-day mRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0399526', 'cui_str': 'Malocclusion, Angle class III'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",20.0,0.0336342,Adequate revascularization (TICI ≥2B) was achieved in 92.3% of patients aged <80 years with an average 1.7±0.1 passes taken with the primary technique and in 88.0% of patients aged ≥80 years with an average 1.7±0.2 passes.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Martini', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mocco', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Aquilla', 'Initials': 'A', 'LastName': 'Turk', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina - College of Medicine, Charleston, South Carolina, USA.'}, {'ForeName': 'Adnan H', 'Initials': 'AH', 'LastName': 'Siddiqui', 'Affiliation': 'Departments of Neurosurgery and Radiology and Toshiba Stroke Research Center, University at Buffalo, State University of New York, Buffalo, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'Department of Neurosurgery, Stony Brook University, Stony Brook, New York, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Hanel', 'Affiliation': 'Stroke & Cerebrovascular Center, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Woodward', 'Affiliation': 'Radiology, Fort Sanders Regional Medical Center, Knoxville, Tennessee, USA.'}, {'ForeName': 'Ansaar', 'Initials': 'A', 'LastName': 'Rai', 'Affiliation': 'Department of Radiology, West Virginia University Hospitals, Morgantown, West Virginia, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Frei', 'Affiliation': 'Interventional Neuroradiology, Radiology Imaging Associates, Englewood, Colorado, USA.'}, {'ForeName': 'Josser E', 'Initials': 'JE', 'LastName': 'Delgado Almandoz', 'Affiliation': 'Department of Interventional Neuroradiology, Abbot Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kelly', 'Affiliation': 'Department of Neurosurgery, Royal University Hospital, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Lissa', 'Initials': 'L', 'LastName': 'Peeling', 'Affiliation': 'Department of Neurosurgery, Royal University Hospital, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Arthur', 'Affiliation': 'UT Dept Neurosurgery/Semmes-Murphey Clinic, Memphis, Tennessee, USA.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Baxter', 'Affiliation': 'Department of Radiology, Erlanger Medical Center, Chattanooga, Tennessee, USA.'}, {'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'English', 'Affiliation': 'Departments of Neurology and Radiology, UCSF, San Francisco, California, USA.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Linfante', 'Affiliation': 'Baptist Cardiac and Vascular Institute, Miami, Florida, USA.'}, {'ForeName': 'Reade', 'Initials': 'R', 'LastName': 'De Leacy', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015093']
3413,31261214,Motor Strategies Learned during Pain Are Sustained upon Pain-free Reexposure to Task.,"INTRODUCTION
Pain affects movement planning and execution, and may interfere with the ability to learn new motor skills. Variations among previous studies suggest task-specific effects of pain on the initial acquisition and subsequent retention of motor strategies.
METHODS
The present study assessed how acute pain in the anterior deltoid muscle affects movement accuracy of fast arm-reaching movements during force field perturbations and upon immediate pain-free repetition of the same task.
RESULTS
Despite having slower initial rate of improvement, individuals who experienced pain during training achieved the same final performance as pain-free controls. However, pain altered the strategy of muscle activation adopted to perform the task, which involved less activity of the shoulder and arm muscles. Strikingly, motor strategies developed during the first exposure to the force field were retained upon reexposure to the same perturbation after resolution of pain.
CONCLUSIONS
Although reduced muscle activation may be interpreted as metabolically efficient, it reduces joint stability and can have negative consequences for joint integrity. These results demonstrate that alternative motor strategies developed in the presence of pain can be maintained when training is resumed after resolution of pain. This effect could have deleterious consequences if it applies when learning motor skills in sports training and rehabilitation.",2019,"The present study assessed how acute pain in the anterior deltoid muscle affects movement accuracy of fast arm-reaching movements during force field perturbations and upon immediate pain-free repetition of the same task.
",[],[],[],[],[],[],,0.0341737,"The present study assessed how acute pain in the anterior deltoid muscle affects movement accuracy of fast arm-reaching movements during force field perturbations and upon immediate pain-free repetition of the same task.
","[{'ForeName': 'Sauro E', 'Initials': 'SE', 'LastName': 'Salomoni', 'Affiliation': 'Centre for Clinical Research Excellence in Spinal Pain, Injury and Health, School of Health and Rehabilitation Science, The University of Queensland, Queensland, AUSTRALIA.'}, {'ForeName': 'Welber', 'Initials': 'W', 'LastName': 'Marinovic', 'Affiliation': 'Centre for Clinical Research Excellence in Spinal Pain, Injury and Health, School of Health and Rehabilitation Science, The University of Queensland, Queensland, AUSTRALIA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Carroll', 'Affiliation': 'Centre for Sensorimotor Performance, School of Human and Nutrition Sciences, The University of Queensland, Queensland, AUSTRALIA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Hodges', 'Affiliation': 'Centre for Clinical Research Excellence in Spinal Pain, Injury and Health, School of Health and Rehabilitation Science, The University of Queensland, Queensland, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002059']
3414,31433665,Role of Omega-3 Polyunsaturated Fatty Acids in Treatment of Nasal Polyposis.,,2020,,[],['Omega-3 Polyunsaturated Fatty Acids'],[],[],"[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]",[],,0.0122002,,"[{'ForeName': 'Tamer M', 'Initials': 'TM', 'LastName': 'Attia', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Menoufia University, Shebeen El-Kom, Egypt.'}]",American journal of rhinology & allergy,['10.1177/1945892419871802']
3415,31462732,Allogeneic transplantation in multiple myeloma: long-term follow-up and cytogenetic subgroup analysis.,"This phase 3 trial compared tandem autologous stem cell transplantation (autoSCT) versus autoSCT followed by reduced-intensity conditioning allogeneic stem cell transplantation (auto/alloSCT) in patients with newly diagnosed multiple myeloma (MM) with deletion of (del) chromosome 13q (del13q). The availability/absence of a human leukocyte antigen-matched-related or matched-unrelated donor (MUD) determined the nature of the second SCT. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population (n = 199). Auto/alloSCT was performed in 126 patients; 74 received MUD allografts. After 91 months median follow-up, median PFS with auto/allo versus tandem autoSCT was 34.5 versus 21.8 months (P = 0.003; adjusted hazard ratio 0.55, 95% confidence interval 0.36-0.84). Median overall survival (OS) was 70.2 versus 71.8 months (P = 0.856). Two-year non-relapse mortality with auto/allo versus tandem autoSCT was 14.3% versus 4.1% (P = 0.008). In patients harboring both del13q and del17p, median PFS and OS were 37.5 and 61.5 months with auto/allo (n = 19) versus 6.1 and 23.4 months with tandem autoSCT (n = 6) (P = 0.0002 and 0.032). Our findings suggest that auto/alloSCT significantly extends PFS versus tandem autoSCT in del13q MM, and indicate some survival benefit for first-line alloSCT in high-risk MM.",2019,Median overall survival (OS) was 70.2 versus 71.8 months (P = 0.856).,"['patients with newly diagnosed multiple myeloma (MM) with deletion of (del) chromosome 13q (del13q', '126 patients; 74 received MUD allografts']","['Allogeneic transplantation', 'tandem autologous stem cell transplantation (autoSCT) versus autoSCT followed by reduced-intensity conditioning allogeneic stem cell transplantation (auto/alloSCT', 'Auto/alloSCT']","['Median overall survival (OS', 'median PFS and OS', 'relapse mortality', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0008633', 'cui_str': 'Chromosome'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3179133', 'cui_str': 'Donors, Unrelated'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]","[{'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",126.0,0.142085,Median overall survival (OS) was 70.2 versus 71.8 months (P = 0.856).,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Knop', 'Affiliation': 'Department of Internal Medicine II, Division of Hematology and Medical Oncology, Würzburg University Medical Centre, Würzburg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Department of Hematology, Oncology and Stem Cell Transplantation, University Medical Centre, Freiburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Liebisch', 'Affiliation': 'Klinik für Innere Medizin III, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Meisner', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biometry, Tübingen University Medical School, Tübingen, Germany.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Holler', 'Affiliation': 'Department of Hematology and Oncology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Metzner', 'Affiliation': 'University Clinic for Internal Medicine - Oncology and Haematology, Oldenburg, Germany.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Peest', 'Affiliation': 'Department of Hematology, Oncology and Haemostaseology, Hanover Medical School, Hanover, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaufmann', 'Affiliation': 'Medical Centre, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Bunjes', 'Affiliation': 'Klinik für Innere Medizin III, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Straka', 'Affiliation': 'Hematology, Oncology and Infectiology, Munich Schwabing Hospital, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fischer', 'Affiliation': 'Department of Hematology and Oncology, Centre of Internal Medicine, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Sezer', 'Affiliation': 'Department of Hematology/Oncology, Charite - Oncology Centre, Berlin, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hentrich', 'Affiliation': 'Hematology and Oncology, Red Cross Hospital, Munich, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Ostermann', 'Affiliation': 'Department of Hematology, University Hospital Grosshadern, Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Bassermann', 'Affiliation': 'IIIrd Department of Internal Medicine, Hematology/Oncology, Technical University, Munich, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Hess', 'Affiliation': 'Department of Hematology, Oncology and Pneumology, Universitätsmedizin Mainz, Mainz, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Internal Medicine I, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Freund', 'Affiliation': 'Hematology, Oncology, Palliative Medicine, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kropff', 'Affiliation': 'Hematology and Oncology, University of Munster, Munster, Germany.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Schmidt', 'Affiliation': 'Department of Internal Medicine, Greifswald University Hospital, Greifswald, Germany.'}, {'ForeName': 'Hans-Heinrich', 'Initials': 'HH', 'LastName': 'Wolf', 'Affiliation': 'Department of Hematology and Oncology, University Hospital, Halle, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Jung', 'Affiliation': 'Hematology and Oncology, Zentrum Innere Medizin, Gottingen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Frickhofen', 'Affiliation': 'Hematology/Oncology, HSK, Dr. Horst-Schmidt-Klinik, Wiesbaden, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Mielke', 'Affiliation': 'Department of Internal Medicine II, Division of Hematology and Medical Oncology, Würzburg University Medical Centre, Würzburg, Germany.'}, {'ForeName': 'Ralf C', 'Initials': 'RC', 'LastName': 'Bargou', 'Affiliation': 'Department of Hematology and Oncology, Charité University Hospital, Berlin, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Ernst von Bergmann Hospital, Potsdam, Germany.'}, {'ForeName': 'Mirija', 'Initials': 'M', 'LastName': 'Svaldi', 'Affiliation': 'Bolzano Municipal Hospital, Bolzano, Italy.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Langer', 'Affiliation': 'Klinik für Innere Medizin III, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gramatzki', 'Affiliation': 'Department of Stem Cell Transplantation and Immunotherapy, Schleswig-Holstein University Hospital, Kiel Campus, Kiel, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Hebart', 'Affiliation': 'Department of Internal Medicine, Stauferklinikum Schwäbisch Gmünd, Mutlangen, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Kanz', 'Affiliation': 'Department for Oncology, Hematology, Immunology, Rheumatology and Pneumology, University Hospital, Tübingen, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Einsele', 'Affiliation': 'Department of Internal Medicine II, Division of Hematology and Medical Oncology, Würzburg University Medical Centre, Würzburg, Germany. einsele_h@ukw.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-019-0537-2']
3416,31474186,Discrimination Between Individual Body Odors Is Unaffected by Perfume.,,2019,,[],[],[],[],[],[],,0.0102088,,"[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Gaby', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, PA, USA; Department of Psychology, Cornell University, Ithaca, NY, USA; Department of Food Science, Penn State University, State College, PA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Dalton', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, PA, USA.'}]",Perception,['10.1177/0301006619872055']
3417,31483735,Two Sides of Face Learning: Improving Between-Identity Discrimination While Tolerating More Within-Person Variability in Appearance.,,2019,,[],[],[],[],[],[],,0.0155603,,"[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Baker', 'Affiliation': 'Department of Psychology, Brock University, St. Catharines, Ontario, Canada.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Mondloch', 'Affiliation': 'Department of Psychology, Brock University, St. Catharines, Ontario, Canada.'}]",Perception,['10.1177/0301006619867862']
3418,31497876,Examining sex as a predictor and moderator of treatment outcomes for binge-eating disorder: Analysis of aggregated randomized controlled trials.,"OBJECTIVE
This study examined whether sex predicted and/or moderated treatment outcomes among men and women who participated in binge-eating disorder (BED) randomized controlled trials (RCTs).
METHOD
Data were aggregated from RCTs performed at one medical center. RCTs tested cognitive-behavioral therapy, behavioral weight loss, multimodal treatment, and/or control conditions. Participants were 660 adults, both men (n = 170) and women (n = 490), with Diagnostic and Statistical Manual-fourth edition (DSM-IV)-defined BED. Doctoral-level research-clinicians assessed participants using structured interviews and established self-report measures of eating-disorder psychopathology and depression, and measured height and weight. Assessments occurred at baseline, throughout treatment, and at post-treatment.
RESULTS
Sex was not a significant moderator of any treatment outcomes. Mixed models revealed sex had a main effect: men had lower eating-disorder psychopathology and lost more weight than women over the course of treatment.
DISCUSSION
Both epidemiological and RCT studies report disparities in treatment-seeking between men and women with BED. Despite this, men have comparable or better treatment outcomes compared with women, including significantly greater weight loss. Thus, disseminating evidence-based BED treatments is promising for both men and women. Additional research is necessary, however, to understand treatment effects-including other predictors and moderators of outcomes-across diverse providers, treatment settings, and patient groups.",2020,"Mixed models revealed sex had a main effect: men had lower eating-disorder psychopathology and lost more weight than women over the course of treatment.
","['Participants were 660 adults, both men (n = 170) and women (n = 490), with Diagnostic and Statistical Manual-fourth edition (DSM-IV)-defined BED', 'men and women who participated in binge-eating disorder (BED) randomized controlled trials (RCTs', 'men and women with BED', 'binge-eating disorder', 'men and women', 'Data were aggregated from RCTs performed at one medical center']",[],"['weight loss', 'lower eating-disorder psychopathology', 'eating-disorder psychopathology and depression, and measured height and weight']","[{'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}]",660.0,0.0450323,"Mixed models revealed sex had a main effect: men had lower eating-disorder psychopathology and lost more weight than women over the course of treatment.
","[{'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Lydecker', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Masheb', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Marney A', 'Initials': 'MA', 'LastName': 'White', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}]",The International journal of eating disorders,['10.1002/eat.23167']
3419,31566147,Evaluation of an alcohol-based antiseptic for nasal decolonization of methicillin-resistant Staphylococcus aureus in colonized patients.,,2019,,['colonized patients'],['alcohol-based antiseptic'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}]",[],,0.0255636,,"[{'ForeName': 'Anubhav', 'Initials': 'A', 'LastName': 'Kanwar', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Kumar', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Yilen K', 'Initials': 'YK', 'LastName': 'Ng-Wong', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Thakur', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Cadnum', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Alhmidi', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Thriveen S C', 'Initials': 'TSC', 'LastName': 'Mana', 'Affiliation': 'Research Service, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Jencson', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Curtis J', 'Initials': 'CJ', 'LastName': 'Donskey', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio.'}]",Infection control and hospital epidemiology,['10.1017/ice.2019.266']
3420,31372762,Beyond the antibodies: serum metabolomic profiling of myasthenia gravis.,"INTRODUCTION
Myasthenia gravis (MG) is a chronic, potentially debilitating autoimmune disease characterized by weakness and rapid fatigue of the voluntary muscles that worsens on exertion. Left untreated, MG symptoms may cause significant morbidity or even death. To date, no robust biological marker is available to follow the course of the disease. Therefore, new diagnostic approaches and biological markers are essential not only for improved diagnosis of the disease but for improved outcomes.
OBJECTIVES
The present study applied a two-control, multi-label metabolomics profiling approach as a potential strategy for the identification of biomarkers unique to myasthenia gravis (MG).
METHODS
Metabolic analyses using acid- and dansyl-labelled serum from seropositive MG (n = 46), rheumatoid arthritis (RA) (n = 23) and healthy controls (HC) (n = 49) were performed on samples from adult patients presenting to the University of Alberta Hospital neuromuscular and rheumatology clinics. Comparisons between patients with MG vs. HC, and RA vs. HC were made using univariate and multivariate statistics.
RESULTS
Serum biomarker patterns were statistically significantly different between groups. Principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA) models exhibited considerable distinction between all groups. Metabolites were then filtered to remove peak pairs common to both disease cohorts. Combined metabolite panels revealed clear separation between MG and HC for both library-matched (AUROC: 0.92 ± 0.03) and highest AUC patients (AUROC: 0.94 ± 0.05).
CONCLUSION
In patients presenting to the clinic with seropositive MG, metabolomic profiling is capable of distinguishing patients with disease from those without. These results provide an important first step towards a potential biomarker for improving MG identification.",2019,Serum biomarker patterns were statistically significantly different between groups.,"['myasthenia gravis', 'n\u2009=\u200946), rheumatoid arthritis (RA) (n\u2009=\u200923) and healthy controls (HC) (n\u2009=\u200949) were performed on samples from adult patients presenting to the University of Alberta Hospital neuromuscular and rheumatology clinics']",['acid- and dansyl-labelled serum from seropositive MG'],['Serum biomarker patterns'],"[{'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3812871', 'cui_str': 'Rheumatology clinic'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C1566145', 'cui_str': '1-myristoyl-2-(12-((5-dimethylamino-1-naphthalenesulfonyl)amino)dodecanoyl)-sn-glycero-3-phosphocholine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",49.0,0.0221381,Serum biomarker patterns were statistically significantly different between groups.,"[{'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Blackmore', 'Affiliation': 'Division of Neurology, University of Alberta, 7th floor, Clinical Sciences Building, 11350 - 83 Ave NW, Edmonton, AB, T6G 2G, Canada. dblackmo@ualberta.ca.'}, {'ForeName': 'Zaeem', 'Initials': 'Z', 'LastName': 'Siddiqi', 'Affiliation': 'Division of Neurology, University of Alberta, 7th floor, Clinical Sciences Building, 11350 - 83 Ave NW, Edmonton, AB, T6G 2G, Canada.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Chemistry, University of Alberta, Chemistry Centre Room W3-39C, Edmonton, AB, T6G 2G2, Canada.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Chemistry, University of Alberta, Chemistry Centre Room W3-39C, Edmonton, AB, T6G 2G2, Canada.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Maksymowych', 'Affiliation': '568A Heritage Medical Research Centre, University of Alberta, Edmonton, AB, T6G 2S2, Canada.'}]",Metabolomics : Official journal of the Metabolomic Society,['10.1007/s11306-019-1571-9']
3421,31120611,Effect of spirometry on exhaled nitric oxide values in asthmatic children.,,2019,,['asthmatic children'],['spirometry'],['exhaled nitric oxide values'],"[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0037981', 'cui_str': 'Spirometry'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0169023,,"[{'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Ninomiya', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Odajima', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Honjo', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}, {'ForeName': 'Kouki', 'Initials': 'K', 'LastName': 'Okabe', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Wakatsuki', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}, {'ForeName': 'Mihoko', 'Initials': 'M', 'LastName': 'Iwata', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}, {'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Taba', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Motomura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Fukuoka National Hospital, Fukuoka city, Japan.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13086']
3422,31127611,Metal trabecular bone reconstruction system better improves clinical efficacy and biomechanical repair of osteonecrosis of the femoral head than free vascularized fibular graft: A case-control study.,"In this study, we aim to compare and analyze the biomechanical repair and clinical efficacy of osteonecrosis of the femoral head (ONFH) with the use of metal trabecular bone reconstruction system and free vascularized fibular graft. The study enrolled 66 adult patients from medical records of nontraumatic ARCO 2A-3B stage ONFH. A simple ONFH model without surgical treatment was established in 13 cases, 29 cases were treated with metal trabecular bone reconstruction system, and 24 cases were treated with free vascularized fibular graft. Computer-recognized and extracted femur outlines were imported, and three-dimensional reconstructions were performed. The stress concentration and stress peak value were analyzed, and the Harris score, visual analog scale pain score, and operation status of the above patients were compared. Finally, quality of life assessment was performed using SF-36 scale. Metal trabecular bone reconstruction system provided less operation time, blood loss, and the total length of postoperative hospital stay than free vascularized fibular graft. Metal trabecular bone reconstruction system promoted bone reconstruction, increased bone mineral density and Harris score. The total clinical effective rate of young patients (20-40 years) was higher than that of older patients (41-60 years). Metal trabecular bone reconstruction system provided higher physical component summary, mental component summary, and role/social component summary than free vascularized fibular graft. This study demonstrates that both metal trabecular bone reconstruction system and free vascularized fibular graft can prevent or delay the progression of ONFH, while metal trabecular bone reconstruction system is a better choice because of better short-term clinical efficacy.",2019,"Metal trabecular bone reconstruction system provided less operation time, blood loss, and the total length of postoperative hospital stay than free vascularized fibular graft.","['young patients (20-40\u2009years) was higher than that of older patients (41-60\u2009years', '66 adult patients from medical records of nontraumatic ARCO 2A-3B stage ONFH']","['vascularized fibular graft', 'Metal trabecular bone reconstruction system', 'metal trabecular bone reconstruction system', 'free vascularized fibular graft', 'metal trabecular bone reconstruction system and free vascularized fibular graft', 'osteonecrosis of the femoral head (ONFH']","['total clinical effective rate', 'stress concentration and stress peak value', 'operation time, blood loss, and the total length of postoperative hospital stay', 'bone mineral density and Harris score', 'quality of life assessment', 'Harris score, visual analog scale pain score, and operation status']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C2743413', 'cui_str': 'ARCO'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0042382', 'cui_str': 'Vascularized'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",66.0,0.0156294,"Metal trabecular bone reconstruction system provided less operation time, blood loss, and the total length of postoperative hospital stay than free vascularized fibular graft.","[{'ForeName': 'Xian-Tao', 'Initials': 'XT', 'LastName': 'Chen', 'Affiliation': 'Department of Osteonecrosis of the Femeral Head, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Ying-Jie', 'Initials': 'YJ', 'LastName': 'Zhu', 'Affiliation': 'Department of Hip Injury, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'You-Wen', 'Initials': 'YW', 'LastName': 'Liu', 'Affiliation': 'Department of Hip Injury, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Hip Injury, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Wen-Wen', 'Initials': 'WW', 'LastName': 'Xu', 'Affiliation': 'TianXinFu Medical Appliance Co., Ltd, Beijing, P.R. China.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'Zhang', 'Affiliation': 'Department of Osteonecrosis of the Femeral Head, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Da-Wei', 'Initials': 'DW', 'LastName': 'Liang', 'Affiliation': 'Department of Osteonecrosis of the Femeral Head, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Osteoarthritis, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Department of Hip Injury, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Ke-Wei', 'Initials': 'KW', 'LastName': 'Tian', 'Affiliation': 'Department of Hip Injury, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Zhang', 'Affiliation': 'Department of Hip Injury, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Hong-Jun', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Department of Hip Injury, Luoyang Orthopedics Hospital of Henan Province, Luoyang, P.R. China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Kang', 'Affiliation': 'TianXinFu Medical Appliance Co., Ltd, Beijing, P.R. China.'}]",Journal of cellular physiology,['10.1002/jcp.28700']
3423,32490976,Baerveldt implant versus trabeculectomy as the first filtering surgery for uncontrolled primary congenital glaucoma: a randomized clinical trial.,"PURPOSE
Our initial goal was to compare the efficacy and safety of a glaucoma drainage device and trabeculectomy for children with primary congenital glaucoma after angular surgery failure. However, we discontinued the study due to the rate of complications and wrote this report to describe the results obtained with the two techniques in this particular group.
METHODS
This was a parallel, non-masked, controlled trial that included patients aged 0-13 years who had undergone previous trabeculotomy or goniotomy and presented inadequately controlled glaucoma with an intraocular pressure ≥21 mmHg on maximum tolerated medical therapy. We randomized the patients to undergo either placement of a 250-mm2 Baerveldt glaucoma implant or mitomycin-augmented trabeculectomy. The main outcome measure was intraocular pressure control. We calculated complete success (without hypotensive ocular medication) and qualified success (with medication) rates. We defined failure as uncontrolled intraocular pressure, presence of serious complications, abnormal increase in ocular dimensions, or confirmed visual acuity decrease.
RESULTS
We studied 13 eyes of 13 children (five in the glaucoma drainage device group; eight in the trabeculectomy group). Both surgical procedures produced a significant intraocular pressure reduction 12 months after intervention from the baseline (tube group, 22.8 ± 5.9 mmHg to 12.20 ± 4.14 mmHg, p=0.0113; trabeculectomy group, 23.7 ± 7.3 mmHg to 15.6 ± 5.9 mmHg, p=0.0297). None of the patients in the tube group and 37.5% of those in the trabeculectomy group achieved complete success in intraocular pressure control after 12 months of follow-up (p=0.928, Chi-square test). Two patients (40%) had serious complications at the time of tube aperture (implant extrusion, retinal detachment).
CONCLUSIONS
Both the tube and trabeculectomy groups presented similar intraocular pressure controls, but complete success was more frequent in the trabeculectomy group. Non-valved glaucoma drainage devices caused potentially blinding complications during tube opening. Because of the small sample size, we could not draw conclusions as to the safety data of the studied technique.",2020,"Both surgical procedures produced a significant intraocular pressure reduction 12 months after intervention from the baseline (tube group, 22.8 ± 5.9 mmHg to 12.20 ± 4.14 mmHg, p=0.0113; trabeculectomy group, 23.7 ± 7.3 mmHg to 15.6 ± 5.9 mmHg, p=0.0297).","['children with primary congenital glaucoma after angular surgery failure', '13 eyes of 13 children (five in the glaucoma drainage device group; eight in the trabeculectomy group', 'uncontrolled primary congenital glaucoma', 'patients aged 0-13 years who had undergone previous trabeculotomy or goniotomy and presented inadequately controlled glaucoma with an intraocular pressure ≥21 mmHg on maximum tolerated medical therapy']","['Baerveldt implant versus trabeculectomy', 'trabeculectomy', '250-mm2 Baerveldt glaucoma implant or mitomycin-augmented trabeculectomy', 'glaucoma drainage device and trabeculectomy']","['serious complications', 'intraocular pressure controls', 'complete success in intraocular pressure control', 'intraocular pressure reduction', 'efficacy and safety', 'complete success', 'ocular dimensions, or confirmed visual acuity decrease', 'intraocular pressure control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1533041', 'cui_str': 'Primary congenital glaucoma'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0600545', 'cui_str': 'Baerveldt Implants'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0456786', 'cui_str': 'sq. mm'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0234632', 'cui_str': 'Reduced visual acuity'}]",13.0,0.099004,"Both surgical procedures produced a significant intraocular pressure reduction 12 months after intervention from the baseline (tube group, 22.8 ± 5.9 mmHg to 12.20 ± 4.14 mmHg, p=0.0113; trabeculectomy group, 23.7 ± 7.3 mmHg to 15.6 ± 5.9 mmHg, p=0.0297).","[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Rolim-de-Moura', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Bruno L B', 'Initials': 'BLB', 'LastName': 'Esporcatte', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'F Netto', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Paranhos', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200060']
3424,32491006,Controlled Study of Central Hemodynamic Changes in Inspiratory Exercise with Different Loads in Heart Failure.,"Background Inspiratory muscle weakness contributes to exercise intolerance and decreased quality of life in patients with heart failure. Studies with inspiratory muscle training show improvement in inspiratory muscle strength, functional capacity and quality of life. However, little is known about the central hemodynamic response (CHR) during inspiratory exercise (IE). Objective To evaluate CHR in a single IE session with different loads (placebo, 30% and 60%) in heart failure. Methods Randomized placebo-controlled clinical trial in patients with heart failure with reduced ejection fraction, functional class II and III. Twenty patients aged 65 ± 11 years completed a single session of inspiratory exercise, in 3 cycles of 15 minutes, with a 1-hour washout, involving loads of 30% (C30), 60% (C60) and placebo, using a linear load resistor (PowerBreathe Light). The noninvasive hemodynamic study was performed by cardiothoracic bioimpedance (Niccomo™ CardioScreen®). Statistical analysis was performed with Student's t-test and Pearson's correlation, and P≤0.05 was considered significant. Results An increase in heart rate (HR) was observed with C30 (64 ± 15 vs 69 ± 15 bpm; p = 0.005) and C60 (67 ± 14 vs 73 ± 14 bpm, p = 0.002). A decrease was observed in systolic volume (SV) with C30 (73 ± 26 vs 64 ± 20 ml; p = 0.004). Cardiac output (CO), on its turn, increased only with C60 (4.6 ± 1.5 vs 5.3 ± 1.7 l/min; p = -0.001). Conclusion When using the 60% load, in a single IE session, changes in CHR were observed. HR and CD increased, as did the Borg scales and subjective sensation of dyspnea. The 30% load reduced the SV. (Arq Bras Cardiol. 2020; 114(4):656-663).",2020,"HR and CD increased, as did the Borg scales and subjective sensation of dyspnea.","['patients with heart failure with reduced ejection fraction, functional class II and III', 'patients with heart failure', 'Twenty patients aged 65 ± 11 years completed a', 'Inspiratory Exercise with Different Loads in Heart Failure']","['placebo', 'single session of inspiratory exercise', 'inspiratory muscle training']","['quality of life', 'CHR', 'inspiratory muscle strength, functional capacity and quality of life', 'systolic volume (SV', 'HR and CD', 'heart failure', 'heart rate (HR', 'SV', 'subjective sensation of dyspnea', 'Cardiac output (CO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",,0.0580409,"HR and CD increased, as did the Borg scales and subjective sensation of dyspnea.","[{'ForeName': 'Luana de Decco', 'Initials': 'LD', 'LastName': 'Marchese', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Chermont', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Warol', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Lucia Brandão de', 'Initials': 'LB', 'LastName': 'Oliveira', 'Affiliation': 'Clínica de Insuficiência Cardíaca, Centro Universitário Serra dos Órgãos, Teresópolis, RJ, Brasil.'}, {'ForeName': 'Sabrina Bernardez', 'Initials': 'SB', 'LastName': 'Pereira', 'Affiliation': 'Hospital do Coração, São Paulo, SP, Brasil.'}, {'ForeName': 'Mônica', 'Initials': 'M', 'LastName': 'Quintão', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Evandro Tinoco', 'Initials': 'ET', 'LastName': 'Mesquita', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20180375']
3425,32491082,Theory-based training to promote breast cancer screening among women with breast cancer worries: randomized controlled trial.,"BACKGROUND
Breast cancer worries are important determinants in relation to behavior favoring breast cancer screening.
OBJECTIVE
To determine the effect of theory-based training to promote breast cancer screening among women with high and low levels of breast cancer worries.
DESIGN AND SETTING
Randomized controlled trial, conducted in two family health centers.
METHODS
In total, 285 women were recruited. Women with low levels of breast cancer worries were included in the first intervention group (112 women) and the first control group (112 women), while women with high levels of breast cancer worries were included in the second intervention group (37 women) and the second control group (43 women). Theory-based training to promote breast cancer screening was given to intervention groups. The women's willingness to undergo breast cancer screening and breast cancer worry scores were evaluated at 1, 3 and 6 months.
RESULTS
The women in the low cancer-worry intervention group performed breast self-examination more in months 1 and 6 following the training, and the women in the high cancer-worry control group performed breast self-examination more in month 3 (P < 0.05). No difference between the women who had low or high levels of breast cancer worries were observed in relation to breast self-examination, clinical breast examination or mammography (P > 0.05).
CONCLUSION
The level of worry did not affect the success of theory-based training, and the training was partially effective with regard to willingness to undergo breast cancer screening.",2020,"No difference between the women who had low or high levels of breast cancer worries were observed in relation to breast self-examination, clinical breast examination or mammography (P > 0.05).
","['285 women were recruited', 'women with breast cancer worries', 'Women with low levels of breast cancer worries were included in the first intervention group (112 women) and the first control group (112 women), while women with high levels of breast cancer worries were included in the second intervention group (37 women) and the second control group (43 women', 'women with high and low levels of breast cancer worries', 'two family health centers']","['Theory-based training to promote breast cancer screening', 'theory-based training']","['breast self-examination', ""women's willingness to undergo breast cancer screening and breast cancer worry scores"", 'breast cancer worries']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}]","[{'cui': 'C0085105', 'cui_str': 'Breast self-examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",285.0,0.0222049,"No difference between the women who had low or high levels of breast cancer worries were observed in relation to breast self-examination, clinical breast examination or mammography (P > 0.05).
","[{'ForeName': 'Sermin Timur', 'Initials': 'ST', 'LastName': 'Taşhan', 'Affiliation': ""Department of Birth, Women's Health and Illness, Faculty of Nursing, Inönü Üniversitesi, Malatya, Turkey.""}, {'ForeName': 'Yeşim Aksoy', 'Initials': 'YA', 'LastName': 'Derya', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Inönü Üniversitesi, Malatya, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Uçar', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Inönü Üniversitesi, Malatya, Turkey.'}, {'ForeName': 'Gülçin', 'Initials': 'G', 'LastName': 'Nacar', 'Affiliation': ""Department of Birth, Women's Health and Illness, Faculty of Nursing, Inönü Üniversitesi, Malatya, Turkey.""}, {'ForeName': 'Behice', 'Initials': 'B', 'LastName': 'Erci', 'Affiliation': 'Department of Public Health, Faculty of Nursing, Inönü Üniversitesi, Malatya, Turkey.'}]",Sao Paulo medical journal = Revista paulista de medicina,['10.1590/1516-3180.2019.033430092019']
3426,32491124,Effects of dry and traditional bed bathing on respiratory parameters: a randomized pilot study.,"OBJECTIVE
to compare the time for performance of dry and traditional bed bathing and its effects on transcutaneous arterial oxygen saturation and respiratory rates in critical adult patients.
METHOD
pilot study of a randomized, open, crossover clinical trial, performed with 15 adult critically ill patients. Each patient received a dry and a traditional bed bath. Analysis of variance with repeated measures was used, adopting p-value ≤ 0.05.
RESULTS
most patients were male (73.3%), white (66.7%), with a mean age of 69.7 years. The dry bath was faster (20.0 minutes) than the traditional bath (30.0 minutes) (p<0.001). There was no significant difference between the patients' saturation means between baths (p=0.381), with 94.7% for the dry bath and 95.2% for the traditional bath. During the traditional bath, the patients' respiratory rate mean was higher (24.2 incursions per minute) and statistically different (p<0.001) from the value obtained for the dry bath (20.5 incursions per minute).
CONCLUSION
the dry bath had a shorter duration than did the traditional bath, resulting in less patient exposure. The traditional bed bath had a negative effect on patients' respiratory rate, increasing it. Brazilian Registry of Clinical Trials (ReBEC): RBR-5qwkqd.",2020,The dry bath was faster (20.0 minutes) than the traditional bath (30.0 minutes) (p<0.001).,"['Brazilian Registry of Clinical Trials (ReBEC', 'most patients were male (73.3%), white (66.7%), with a mean age of 69.7 years', 'critical adult patients', '15 adult critically ill patients']",['dry and traditional bed bathing'],"['transcutaneous arterial oxygen saturation and respiratory rates', 'respiratory parameters', 'respiratory rate mean']","[{'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}]","[{'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",15.0,0.0337215,The dry bath was faster (20.0 minutes) than the traditional bath (30.0 minutes) (p<0.001).,"[{'ForeName': 'Luana Vieira', 'Initials': 'LV', 'LastName': 'Toledo', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Patrícia de Oliveira', 'Initials': 'PO', 'LastName': 'Salgado', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Cristiane Chaves de', 'Initials': 'CC', 'LastName': 'Souza', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Lídia Miranda', 'Initials': 'LM', 'LastName': 'Brinati', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital São Sebastião, Viçosa, MG, Brasil.'}, {'ForeName': 'Carla de Fátima', 'Initials': 'CF', 'LastName': 'Januário', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Flávia Falci', 'Initials': 'FF', 'LastName': 'Ercole', 'Affiliation': 'Escola de Enfermagem, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brasil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3668.3264']
3427,32491139,Formononetin accelerates mycorrhization and increases maize production at low phosphorus application rates.,"Abstract: The formononetin biostimulant may be an option for reducing P fertilization once it stimulates mycelial growth of arbuscular mycorrhizal fungi and increases plant ability to take up nutrients through the roots, especially phosphorus. The objective of this study was to evaluate the effect of formononetin associated with phosphorus fertilization in maize. Field experiments were conducted in a randomized block design with a 3 × 4 factorial arrangement (0, 50 or 70, and 140 kg ha-1 P2O5; and formononetin application rates: 0, 25, 50, and 100 g ha-1), with four replications. Formononetin (100 g ha-1) increased the mycorrhizal colonization rate up to 30% in maize in the first four weeks after emergence when no P fertilizer was applied, and to 17% when 50 or 70 kg ha-1 of P2O5 were applied. The application of 50 and 100 g ha-1 of formononetin significantly increased plant height, ear height, and grain yield (22% - 76%) when no P fertilizer was applied. The use of formononetin in the field stimulates mycorrhizal colonization, has a positive effect on maize yield, and reduces the need for P fertilizer application in maize. However, this effect was evident only at low P soil contents.",2020,"Formononetin (100 g ha-1) increased the mycorrhizal colonization rate up to 30% in maize in the first four weeks after emergence when no P fertilizer was applied, and to 17% when 50 or 70 kg ha-1 of P2O5 were applied.",['maize'],"['formononetin', 'Formononetin']","['plant height, ear height, and grain yield', 'mycorrhizal colonization rate']","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}]","[{'cui': 'C0060656', 'cui_str': 'formononetin'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}]",,0.0358698,"Formononetin (100 g ha-1) increased the mycorrhizal colonization rate up to 30% in maize in the first four weeks after emergence when no P fertilizer was applied, and to 17% when 50 or 70 kg ha-1 of P2O5 were applied.","[{'ForeName': 'Jessé V Dos', 'Initials': 'JVD', 'LastName': 'Santos', 'Affiliation': 'Programa de Pós-Graduação em Microbiologia Agrícola, Universidade Federal de Lavras, Lavras, MG, Brazil.'}, {'ForeName': 'Paula R A', 'Initials': 'PRA', 'LastName': 'Ribeiro', 'Affiliation': 'Programa de Pós-Graduação em Microbiologia Agrícola, Universidade Federal de Lavras, Lavras, MG, Brazil.'}, {'ForeName': 'Maria Angélica B', 'Initials': 'MAB', 'LastName': 'Carneiro', 'Affiliation': 'Instituto de Ciências Agrárias, Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'Isaac C', 'Initials': 'IC', 'LastName': 'Soares', 'Affiliation': 'Departamento de Ciência do Solo, Universidade Federal de Lavras, Lavras, MG, Brazil.'}, {'ForeName': 'Ivan V A', 'Initials': 'IVA', 'LastName': 'Fiorini', 'Affiliation': 'Departamento de Agricultura, Universidade Federal de Lavras, Lavras, MG, Brazil.'}, {'ForeName': 'Leandro L', 'Initials': 'LL', 'LastName': 'Cancellier', 'Affiliation': 'Departamento de Agricultura, Universidade Federal de Lavras, Lavras, MG, Brazil.'}, {'ForeName': 'Adriano D', 'Initials': 'AD', 'LastName': 'Veiga', 'Affiliation': 'BR-020, Empresa Brasileira de Pesquisa Agropecuária - Embrapa Cerrados, Brasília, DF, Brazil.'}, {'ForeName': 'Carlos Juliano B', 'Initials': 'CJB', 'LastName': 'Albuquerque', 'Affiliation': 'Unidade Experimental do Triângulo e Alto Paranaíba, Empresa de Pesquisa Agropecuária de Minas Gerais/EPAMIG, Uberlândia, MG, Brazil.'}, {'ForeName': 'Renzo G VON', 'Initials': 'RGV', 'LastName': 'Pinho', 'Affiliation': 'Departamento de Agricultura, Universidade Federal de Lavras, Lavras, MG, Brazil.'}, {'ForeName': 'Fatima M S', 'Initials': 'FMS', 'LastName': 'Moreira', 'Affiliation': 'Departamento de Ciência do Solo, Universidade Federal de Lavras, Lavras, MG, Brazil.'}]",Anais da Academia Brasileira de Ciencias,['10.1590/0001-3765202020181371']
3428,32491152,Weight-Related Information Avoidance Prospectively Predicts Poorer Self-Monitoring and Engagement in a Behavioral Weight Loss Intervention.,"BACKGROUND
Self-monitoring is a key component of behavioral weight loss (BWL) interventions. Past research suggests that individuals may avoid self-monitoring in certain contexts (e.g., skipping self-weighing after higher-than-usual calorie intake). However, no studies have attempted to quantify individuals' inclination to avoid information about their weight control (""weight-related information avoidance""; WIA) or prospectively examined its implications for treatment engagement and outcomes in BWL programs.
PURPOSE
Characterize WIA using a validated questionnaire among adults enrolled in BWL treatment and examine whether WIA prospectively predicts self-monitoring adherence, session attendance, treatment discontinuation, or weight loss.
METHODS
Participants (N = 87; MBMI = 34.9 kg/m2, 83% female) completed a measure of WIA prior to starting a 12 week, group-based BWL intervention. Participants were given digital self-monitoring tools and instructed to self-monitor their food intake daily, physical activity daily, and body weight weekly (Weeks 1-10) and then daily (Weeks 11-12). Session attendance and treatment discontinuation were recorded. Weight was measured in-clinic pretreatment and posttreatment.
RESULTS
While mean WIA was low (M = 2.23, standard deviation [SD] = 0.95; potential scale range: 1-7), greater WIA predicted poorer attendance (r = -.23; p = .03) and poorer self-monitoring of physical activity (r = -.28; p = .009) and body weight (r = -.32; p = .003). WIA did not predict food monitoring (p = .08), treatment discontinuation (p = .09), or 12 week weight loss (p = .91).
CONCLUSIONS
Greater WIA, as assessed via a brief questionnaire, may place individuals at risk for poorer self-monitoring and treatment engagement during BWL. Further research on the implications of WIA in the context of weight management is warranted, including evaluation of correlates, moderators, and mechanisms of action of WIA.
CLINICAL TRIAL REGISTRATION
NCT03337139.",2020,"WIA did not predict food monitoring (p = .08), treatment discontinuation (p = .09), or 12 week weight loss (p = .91).
","['adults enrolled in BWL treatment', 'Participants (N = 87; MBMI = 34.9 kg/m2, 83% female']",[],"['body weight', 'poorer self-monitoring of physical activity', 'Weight-Related Information Avoidance', 'Weight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0202255,"WIA did not predict food monitoring (p = .08), treatment discontinuation (p = .09), or 12 week weight loss (p = .91).
","[{'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Schumacher', 'Affiliation': 'Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, RI, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Martinelli', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Alexandra D', 'Initials': 'AD', 'LastName': 'Convertino', 'Affiliation': 'San Diego State University/University of California San Diego, Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, PA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa034']
3429,32491154,Spousal Influence on Diabetes Self-care: Moderating Effects of Distress and Relationship Quality on Glycemic Control.,"BACKGROUND
Spouses often attempt to influence patients' diabetes self-care. Spousal influence has been linked to beneficial health outcomes in some studies, but to negative outcomes in others.
PURPOSE
We aimed to clarify the conditions under which spousal influence impedes glycemic control in patients with type 2 diabetes. Spousal influence was hypothesized to associate with poorer glycemic control among patients with high diabetes distress and low relationship quality.
METHODS
Patients with type 2 diabetes and their spouses (N = 63 couples) completed self-report measures before patients initiated a 7-day period of continuous glucose monitoring. Mean glucose level and coefficient of variation (CV) were regressed on spousal influence, diabetes distress, relationship quality, and their two- and three-way interactions.
RESULTS
The three-way interaction significantly predicted glucose variability, but not mean level. Results revealed a cross-over interaction between spousal influence and diabetes distress at high (but not low) levels of relationship quality, such that spousal influence was associated with less variability among patients with low distress, but more among those with high distress. Among patients with high distress and low relationship quality, a 1 SD increase in spousal influence predicted a difference roughly equivalent to the difference between the sample mean CV and a CV in the unstable glycemia range.
CONCLUSIONS
This was the first study to examine moderators of the link between spousal influence and glycemic control in diabetes. A large effect was found for glucose variability, but not mean levels. These novel results highlight the importance of intimate relationships in diabetes management.",2020,"The three-way interaction significantly predicted glucose variability, but not mean level.","['diabetes', 'patients with high diabetes distress', 'Diabetes Self-care', 'patients with type 2 diabetes', 'Patients with type 2 diabetes and their spouses (N = 63 couples) completed']",['self-report measures before patients initiated a 7-day period of continuous glucose monitoring'],"['glucose variability', 'spousal influence, diabetes distress, relationship quality, and their two- and three-way interactions', 'diabetes distress', 'Mean glucose level and coefficient of variation (CV', 'glycemic control']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",63.0,0.0160957,"The three-way interaction significantly predicted glucose variability, but not mean level.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Soriano', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Lenhard', 'Affiliation': 'Section of Endocrinology and Metabolism, Christiana Care Health System, Wilmington, DE, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University; Departments of Medicine and Epidemiology & Population Health, Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Tennen', 'Affiliation': 'Department of Community Medicine and Department of Psychiatry, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Sy-Miin', 'Initials': 'SM', 'LastName': 'Chow', 'Affiliation': 'Department of Human Development and Family Studies, Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Perndorfer', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Biing-Jiun', 'Initials': 'BJ', 'LastName': 'Shen', 'Affiliation': 'Division of Psychology, School of Humanities and Social Sciences, Nanyang Technological University, Singapore.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Siegel', 'Affiliation': 'Value Institute, Christiana Care Health System, Wilmington, DE, USA.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Laurenceau', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, Newark, DE, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa038']
3430,32491233,Intrauterine versus external tocodynamometry in monitoring labour: A randomised controlled clinical trial.,"OBJECTIVE
To investigate whether the use of intrauterine vs. external tocodynamometry (IT vs. ET) during labour reduces operative deliveries and improves newborn outcome. As IT provides more accurate information on labour contractions, the hypothesis was that it may more appropriately guide oxytocin use than ET.
DESIGN
Randomised controlled trial.
SETTING
Two labour wards, in a university tertiary hospital and a central hospital.
POPULATION
1504 parturients with singleton pregnancies, gestational age ≥ 37 weeks and fetus in cephalic position: 269 women with uterine scars, 889 nulliparas and 346 parous women with oxytocin augmentation.
METHODS
Participants underwent IT (n=736) or ET (n=768) during the active first stage of labour.
MAIN OUTCOME MEASURES
Primary outcome: rate of operative deliveries.
SECONDARY OUTCOMES
duration of labour, amount of oxytocin given, adverse neonatal outcomes.
RESULTS
Operative delivery rates were 26.9% (IT) and 25.9% (ET) (OR 1.05, 95% CI 0.84-1.32, P=0.663). The ET to IT conversion rate was 31%. We found no differences in secondary outcomes (IT vs. ET). IT reduced oxytocin use during labours with signs of fetal distress, and TOLAC.
CONCLUSIONS
IT did not reduce the rate of operative deliveries, use of oxytocin, or adverse neonatal outcomes, and it did not shorten labour duration.",2020,"IT did not reduce the rate of operative deliveries, use of oxytocin, or adverse neonatal outcomes, and it did not shorten labour duration.","['Two labour wards, in a university tertiary hospital and a central hospital', 'monitoring labour', '1504 parturients with singleton pregnancies, gestational age', '≥ 37 weeks and fetus in cephalic position', '269 women with uterine scars, 889 nulliparas and 346 parous women with oxytocin augmentation', 'Participants underwent IT (n=736) or ET (n=768) during the active first stage of labour']","['intrauterine vs. external tocodynamometry (IT vs. ET', 'Intrauterine versus external tocodynamometry']","['operative deliveries and improves newborn outcome', 'rate of operative deliveries', 'rate of operative deliveries, use of oxytocin, or adverse neonatal outcomes', 'duration of labour, amount of oxytocin given, adverse neonatal outcomes', 'Operative delivery rates']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}]","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040345', 'cui_str': 'Tocodynamometry'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C1947971', 'cui_str': 'Give'}]",269.0,0.239797,"IT did not reduce the rate of operative deliveries, use of oxytocin, or adverse neonatal outcomes, and it did not shorten labour duration.","[{'ForeName': 'Tuija', 'Initials': 'T', 'LastName': 'Hautakangas', 'Affiliation': 'Department of Obstetrics and Gynecology, Central Hospital of Central Finland, Keskussairaalantie 19, 40620, Jyväskylä, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Uotila', 'Affiliation': 'Department of Obstetrics and Gynecology, Tampere University Hospital and Faculty of Medicine and Health Technology, Tampere University, PL, 2000, 33521, Tampere, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'University Instructor, Faculty of Social Sciences, Tampere University, Arvo Ylpön katu 34, 33520, Tampere, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Palomäki', 'Affiliation': 'Department of Obstetrics and Gynecology, Tampere University Hospital and Faculty of Medicine and Health Technology, Tampere University, PL, 2000, 33521, Tampere, Finland.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16343']
3431,32491236,The McGill Denture Satisfaction Questionnaire revisited: Exploratory factor analysis of a binational sample.,"OBJECTIVES
To examine the McGill Denture Satisfaction Questionnaire (MDSQ) in terms of dimensionality, item reduction and construct validity in a binational sample of complete denture wearers.
MATERIALS AND METHODS
We conducted secondary analyses of baseline data from two studies on implant-retained overdentures: a quasi-experimental study in the United States (n = 145) and a randomised trial in Brazil (n = 120). All participants wore upper/lower dentures and responded at baseline to the MDSQ items concerning their original mandibular dentures. A putative model of the MDSQ items resulted in two question subsets: (a) overall satisfaction, retention/stability, aesthetics, cleaning, speech and comfort, plus general chewing ability; (b) mastication of specific foods. Analyses focused on the internal consistency of each subset and possible item reduction, using Cronbach's alpha (Cα), inter-item correlation and exploratory factor analysis (EFA).
RESULTS
The 1st subset showed high inter-item correlation for most question combinations and no redundancy (r ≤ .8). An item on cleaning had low correlation, but its removal does not increase internal consistency (Cα ≥ .83). Results were similar for both studies, with EFA showing a single significant factor (namely ""overall satisfaction, lower denture"") able to explain nearly 54% of the variance. The 2nd subset also shows strong internal consistency (Cα ≥ .95) and inter-item correlation, with a single factor representing 65% of the variation.
CONCLUSIONS
This study discloses the reliability and construct validity of the MDSQ for patient-centred evaluation of complete dental prostheses in the edentulous mandible. Findings also support the use of both ""overall satisfaction"" and ""masticatory ability"" as summary scores, for improved outcome assessment.",2020,The 1st subset showed high inter-item correlation for most question combinations and no redundancy (r ≤ .8).,"['patient-centred evaluation of complete dental prostheses in the edentulous mandible', 'We conducted secondary analyses of baseline data from two studies on implant-retained overdentures: a quasi-experimental study in the United States (n\xa0=\xa0145) and a randomised trial in Brazil (n\xa0=\xa0120', 'binational sample of complete denture wearers']",['MDSQ'],"['overall satisfaction, retention/stability, aesthetics, cleaning, speech and comfort, plus general chewing ability; (b) mastication of specific foods', 'internal consistency ', ""Cronbach's alpha (Cα), inter-item correlation and exploratory factor analysis (EFA"", 'McGill Denture Satisfaction Questionnaire (MDSQ', 'single significant factor (namely ""overall satisfaction, lower denture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",145.0,0.0931388,The 1st subset showed high inter-item correlation for most question combinations and no redundancy (r ≤ .8).,"[{'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Adriana B', 'Initials': 'AB', 'LastName': 'Ribeiro', 'Affiliation': 'School of Dentistry, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Oates', 'Affiliation': 'School of Dentistry, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Jocelyne S', 'Initials': 'JS', 'LastName': 'Feine', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, Montreal, QC, Canada.'}]",Gerodontology,['10.1111/ger.12477']
3432,32486007,No Significant Differences in Muscle Growth and Strength Development When Consuming Soy and Whey Protein Supplements Matched for Leucine Following a 12 Week Resistance Training Program in Men and Women: A Randomized Trial.,"There are conflicting reports regarding the efficacy of plant versus animal-derived protein to support muscle and strength development with resistance training. The purpose of this study was to determine whether soy and whey protein supplements matched for leucine would comparably support strength increases and muscle growth following 12 weeks of resistance training. Sixty-one untrained young men ( n = 19) and women ( n = 42) (18-35 year) enrolled in this study, and 48 completed the trial (17 men, 31 women). All participants engaged in supervised resistance training 3×/week and consumed 19 grams of whey protein isolate or 26 grams of soy protein isolate, both containing 2 g (grams) of leucine. Multi-level modeling indicated that total body mass (0.68 kg; 95% CI: 0.08, 1.29 kg; p < 0.001), lean body mass (1.54 kg; 95% CI: 0.94, 2.15 kg; p < 0.001), and peak torque of leg extensors (40.27 Nm; 95% CI: 28.98, 51.57 Nm, p < 0.001) and flexors (20.44 Nm; 95% CI: 12.10, 28.79 Nm; p < 0.001) increased in both groups. Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm; p = 0.08). No differences between groups were observed ( p > 0.05). These data indicate that increases in lean mass and strength in untrained participants are comparable when strength training and supplementing with soy or whey matched for leucine.",2020,"Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm; p = 0.08).","['Sixty-one untrained young men ( n = 19) and women ( n = 42) (18-35 year) enrolled in this study, and 48 completed the trial (17 men, 31 women', 'untrained participants', 'Men and Women']","['Resistance Training Program', 'soy and whey protein supplements matched for leucine', 'supervised resistance training 3×/week and consumed 19 grams of whey protein isolate or 26 grams of soy protein isolate, both containing 2 g (grams) of leucine', 'Consuming Soy and Whey Protein Supplements Matched for Leucine']","['lean mass and strength', 'total body mass', 'lean body mass', 'Vastus lateralis muscle thickness', 'Muscle Growth and Strength Development', 'peak torque of leg extensors']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0677666', 'cui_str': 'soy protein isolate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",61.0,0.0891844,"Vastus lateralis muscle thickness tended to increase, but this did not reach statistical significance (0.12 cm; 95% CI: -0.01, 0.26 cm; p = 0.08).","[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Lynch', 'Affiliation': 'Department of Kinesiology, Point Loma Nazarene University, San Diego, CA 92106, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Dickinson', 'Affiliation': 'Health Sciences, Central Washington University, Ellensburg, WA, 98926, USA.'}, {'ForeName': 'Lynda B', 'Initials': 'LB', 'LastName': 'Ransdell', 'Affiliation': 'College of Health and Human Services, Northern Arizona University, Flagstaff, AZ 86011, USA.'}, {'ForeName': 'Carol S', 'Initials': 'CS', 'LastName': 'Johnston', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Wharton', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17113871']
3433,32486025,"Compression Stocking Length Effects on Oedema, Pain, and Satisfaction in Nursing Students: A Pilot Randomized Trial.","Professional practitioners who are required to stand for long periods of time frequently complain about vein-related symptoms. Compression stocking are effective for vein-related symptoms, but there is not enough evidence on the effect of the length of compression stockings for nursing students. To compare oedema, pain, and satisfaction according to different lengths of compression stockings worn by female nursing students. This study was conducted as a randomized clinical trial. The participants included 20 female nursing students in their first semester of clinical practice training. Compression stockings with 25-32 mmHg pressure were used in the study; the participants were divided into two groups based on the length of compression stocking: knee length and thigh length. Differences between groups regarding pain, oedema, and satisfaction were analysed using t-tests, paired t-tests, and Mann-Whitney U tests, when appropriate. There were no significant differences in pain, oedema, and satisfaction between the two groups. However, pain in right legs of the thigh-length stocking group significantly increased after clinical training shift compared with that before the shift (t = -2.377, p = 0.041). Both groups reported high satisfaction. There were no differences in pain, oedema, and satisfaction in both legs based on the length of compression stockings, but side effects appeared in participants wearing the thigh-length stockings; nevertheless, satisfaction was high in both groups. It may be important to suggest nursing students to wear knee-length compression stockings during clinical practice training.",2020,"There were no differences in pain, oedema, and satisfaction in both legs based on the length of compression stockings, but side effects appeared in participants wearing the thigh-length stockings; nevertheless, satisfaction was high in both groups.","['participants included 20 female nursing students in their first semester of clinical practice training', 'Professional practitioners', 'Nursing Students', 'female nursing students']","['Compression stocking', 'Compression stockings']","['Oedema, Pain, and Satisfaction', 'pain, oedema, and satisfaction', 'oedema, pain, and satisfaction', 'satisfaction', 'pain in right legs', 'pain, oedema, and satisfaction in both legs based on the length of compression stockings']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038348', 'cui_str': 'Compression stocking'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0564823', 'cui_str': 'Pain in right lower limb'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}]",20.0,0.0330258,"There were no differences in pain, oedema, and satisfaction in both legs based on the length of compression stockings, but side effects appeared in participants wearing the thigh-length stockings; nevertheless, satisfaction was high in both groups.","[{'ForeName': 'Yoonyoung', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Sunchon National University, Suncheon, Jeollanam-do 57922, Korea.'}, {'ForeName': 'Kisook', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Chung-Ang University, Seoul 06974, Korea.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Nursing, Korea University Ansan Medicine, Ansan, Geyonggi-do 15355, Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Kyunghee University Medical Center, Seoul 02447, Korea.'}, {'ForeName': 'Su Gyeong', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Sunchon National University, Suncheon, Jeollanam-do 57922, Korea.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Army Nurse, Korea Army, Korea.'}, {'ForeName': 'Jisu', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Department of Nursing, Asan Medical Center, Seoul 05505, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020149']
3434,32486104,Non-Steroidal Anti-Inflammatory Drug Etoricoxib Facilitates the Application of Individualized Exercise Programs in Patients with Ankylosing Spondylitis.,"Background and objectives: The main objective of this study is to highlight the efficiency of different therapeutic means in patients with ankylosing spondylitis, resulting in the improvement of their quality of life. Materials and Methods: We conducted a randomized, longitudinal, controlled trial on 92 patients with ankylosing spondylitis over a period of 6 years. Disease activity was assessed using the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score. The assessment of functional disabilities was performed using BASFI (Bath Ankylosing Spondylitis Functional Index). We assessed the quality of life using the HAQ questionnaire (Health Assessment Questionnaire). Based on the HAQ, we calculated the minimum number of patients to be treated for 52 weeks to prevent a decrease in the quality of life for at least one of them (the number needed to treat (NNT)). Results: For the combination therapy group, the result we obtained was 2, lower than the other therapies compared (the medication group and the group with physical exercise). We point out a correlation between the improvement of the functional status (BASFI) and the increase of the quality of life (HAQ), estimated as moderately high (0.8). The superiority of the effects of the combined treatment, in which we combined a nonsteroidal anti-inflammatory drug (etoricoxib) to the exercise program, is reflected by the model of the significant improvements ( p < 0.05) obtained for the functional status and quality of life scores (BASFI and HAQ). Conclusions: The nonsteroidal anti-inflammatory drugs, in our case, etoricoxib, facilitate the application of individualized exercise programs in patients with ankylosing spondylitis.",2020,"For the combination therapy group, the result we obtained was 2, lower than the other therapies compared (the medication group and the group with physical exercise).","['Patients with Ankylosing Spondylitis', 'patients with ankylosing spondylitis', '92 patients with ankylosing spondylitis over a period of 6 years']","['Etoricoxib', 'individualized exercise programs', 'nonsteroidal anti-inflammatory drug (etoricoxib', 'etoricoxib']","['quality of life', 'BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score', 'functional status and quality of life scores (BASFI and HAQ', 'Disease activity', 'quality of life using the HAQ questionnaire (Health Assessment Questionnaire', 'functional status (BASFI', 'quality of life (HAQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}]",92.0,0.0280411,"For the combination therapy group, the result we obtained was 2, lower than the other therapies compared (the medication group and the group with physical exercise).","[{'ForeName': 'Iulia Rahela', 'Initials': 'IR', 'LastName': 'Marcu', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, University of Medicine and Pharmacy of Craiova, 200349 Craiova, Romania.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Dop', 'Affiliation': 'Department of Pediatrics, University of Medicine and Pharmacy of Craiova, 200349, Craiova, Romania.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Padureanu', 'Affiliation': 'Department of Internal Medicine, University of Medicine and Pharmacy of Craiova, 200349 Craiova, Romania.'}, {'ForeName': 'Stefan Adrian', 'Initials': 'SA', 'LastName': 'Niculescu', 'Affiliation': 'Department of Orthopedics, University of Medicine and Pharmacy of Craiova, 200349 Craiova, Romania.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Padureanu', 'Affiliation': 'Department of Biochemistry, University of Medicine and Pharmacy of Craiova, 200349 Craiova, Romania.'}, {'ForeName': 'Carmen Elena', 'Initials': 'CE', 'LastName': 'Niculescu', 'Affiliation': 'Department of Pediatrics, University of Medicine and Pharmacy of Craiova, 200349, Craiova, Romania.'}, {'ForeName': 'Otilia Constantina', 'Initials': 'OC', 'LastName': 'Rogoveanu', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, University of Medicine and Pharmacy of Craiova, 200349 Craiova, Romania.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56060270']
3435,32486256,Docosahexaenoic Acid-Rich Fish Oil Supplementation Reduces Kinase Associated with Insulin Resistance in Overweight and Obese Midlife Adults.,"Targeting kinases linked to insulin resistance (IR) and inflammation may help in reducing the risk of type 2 diabetes (T2D) and Alzheimer's disease (AD) in its early stages. This study aimed to determine whether DHA-rich fish oil supplementation reduces glycogen synthase kinase (GSK-3), which is linked to both IR and AD. Baseline and post-intervention plasma samples from 58 adults with abdominal obesity (Age: 51.7 ± 1.7 years, BMI: 31.9 ± 0.8 kg/m 2 ) were analysed for outcome measures. Participants were allocated to 2 g DHA-rich fish oil capsules (860 mg DHA + 120 mg EPA) (n = 31) or placebo capsules (n = 27) per day for 12 weeks. Compared to placebo, DHA-rich fish oil significantly reduced GSK-3β by -2.3 ± 0.3 ng/mL. An inverse correlation ( p < 0.05) was found between baseline insulin and IR and their changes following intervention only in participants with C-reactive protein levels higher than 2.4 mg/L. DHA-rich fish oil reduces GSK-3 and IR, suggesting a potential role of long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) in ameliorating AD risk.",2020,"Compared to placebo, DHA-rich fish oil significantly reduced GSK-3β by -2.3 ± 0.3 ng/mL.","['Overweight and Obese Midlife Adults', '58 adults with abdominal obesity (Age: 51.7 ± 1.7 years, BMI: 31.9 ± 0.8 kg/m 2 ']","['DHA-rich fish oil supplementation', 'DHA-rich fish oil capsules (860 mg DHA + 120 mg EPA', 'placebo capsules', 'placebo, DHA-rich fish oil', 'Docosahexaenoic Acid-Rich Fish Oil Supplementation']",[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",[],58.0,0.299726,"Compared to placebo, DHA-rich fish oil significantly reduced GSK-3β by -2.3 ± 0.3 ng/mL.","[{'ForeName': 'Rohith N', 'Initials': 'RN', 'LastName': 'Thota', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Jessica I', 'Initials': 'JI', 'LastName': 'Rosato', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Cintia B', 'Initials': 'CB', 'LastName': 'Dias', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Kylie A', 'Initials': 'KA', 'LastName': 'Abbott', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Ralph N', 'Initials': 'RN', 'LastName': 'Martins', 'Affiliation': 'Department of Biomedical Sciences, Macquarie University, North Ryde NSW 2109, Australia.'}, {'ForeName': 'Manohar L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan NSW 2308, Australia.'}]",Nutrients,['10.3390/nu12061612']
3436,32488687,Motivational Interviewing and Caregiver Engagement in the Family Check-Up 4 Health.,"Motivational interviewing (MI) is a therapeutic style in which a provider elicits client motivation and helps strengthen commitment to change (Miller and Rollnick 2002). The original Family Check-Up (FCU; Dishion and Stormshak 2007)-and the adapted version for improving health behaviors in primary care, the Family Check-Up 4 Health (FCU4Health; Smith et al. 2018a)-are brief, assessment-driven, and family-centered preventive interventions that use MI to improve parent engagement in services to improve parenting and prevent negative child outcomes. This study examines the role of MI in the Raising Healthy Children project, a randomized trial to test the effectiveness of the FCU4Health for the prevention of obesity in pediatric primary care, with data from the 141 families assigned to receive the FCU4Health. Families were eligible for the study if the child was between 5.5 and 12 years of age at the time of identification and had a BMI ≥ 85th percentile for age and gender at the most recent visit to their primary care provider. MI skills at the first session predicted caregiver in-session active engagement, attendance at follow-up parenting sessions, and improvements in motivation to address child health and behavior goals. Baseline characteristics of the family (i.e., child health diagnosis, caregiver baseline depression, motivation, and Spanish language preference) had differential associations with responsiveness and MI skills. This study has implications for program development, provider training, and fidelity monitoring.",2020,"MI skills at the first session predicted caregiver in-session active engagement, attendance at follow-up parenting sessions, and improvements in motivation to address child health and behavior goals.","['pediatric primary care, with data from the 141 families assigned to receive the FCU4Health', 'Healthy Children project', 'Families were eligible for the study if the child was between 5.5 and 12\xa0years of age at the time of identification and had a BMI\u2009≥\u200985th percentile for age and gender at the most recent visit to their primary care provider']","['Motivational interviewing (MI', 'FCU4Health', 'Motivational Interviewing and Caregiver Engagement']","['child health diagnosis, caregiver baseline depression, motivation, and Spanish language preference', 'motivation to address child health and behavior goals', 'MI skills']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",,0.0171541,"MI skills at the first session predicted caregiver in-session active engagement, attendance at follow-up parenting sessions, and improvements in motivation to address child health and behavior goals.","[{'ForeName': 'Cady', 'Initials': 'C', 'LastName': 'Berkel', 'Affiliation': 'Department of Psychology, REACH Institute, Arizona State University, 900 S McAllister Ave, Tempe, AZ, USA. Cady.Berkel@asu.edu.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Mauricio', 'Affiliation': 'Department of Psychology, REACH Institute, Arizona State University, 900 S McAllister Ave, Tempe, AZ, USA.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Rudo-Stern', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, AZ, USA.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'Department of Psychology, REACH Institute, Arizona State University, 900 S McAllister Ave, Tempe, AZ, USA.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Center for Prevention Implementation Methodology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01112-8']
3437,32488745,Primary Roux-en-Y Gastric Bypass Results in Greater Weight Loss at 15-Year Follow-Up Compared with Secondary Roux-en-Y Gastric Bypass After Failure of Gastric Band or Mason McLean Vertical Gastroplasty.,"PURPOSE
The aim of the study is to compare the outcomes of patients treated with secondary Roux-en-Y gastric bypass (RYGB) after adjustable gastric banding (AGB) or vertical banded gastroplasty (VBG) with those of patients having primary RYGB.
MATERIALS AND METHODS
Patients undergoing secondary RYGB after AGB or VBG between 1997 and 2004 with a minimal follow-up of 15 years were matched using a propensity score (according to gender, age, BMI, duration of follow-up) with comparable patients who underwent primary RYGB.
RESULTS
The mean follow-up was 16.50 years in the secondary RYGB group (N = 32) versus 16.33 years in the primary RYGB group (N = 32). Early postoperative complications rate was 6.25% in the secondary RYGBs versus 9.38% in the primary RYGBs (P = 1). Late postoperative complications and additional surgical procedures were 56.25% and 37.5% in the secondary and primary RYGB group, respectively (P = 0.21). Long-term (at 16-20 years) %TWL and %EWL were significantly lower (P < 0.01 and P = 0.013, respectively) after secondary RYGB (%TWL = 7.56%; %EWL = 17.15%) than after primary RYGB (%TWL = 24.51%; %EWL = 55.61%). Remission of obesity-related comorbidities was comparable (P > 0.05). Gastroesophageal reflux was more frequent after secondary RGYB-43.75% versus 25%, P < 0.05. Quality of life-Morehead-Ardelt II score (0.02 in secondary RYGB versus 0.69 in primary RYGB, P = 0.13), general self-assessment of health status and weight satisfaction were comparable.
CONCLUSION
Secondary RYGB after AGB or VBG is less efficient at weight loss, GERD remission and energy expenditure at 15 years after conversion. However, it is as effective for improvement/resolution of obesity-related comorbidities and is associated with similar QoL scores.",2020,"Gastroesophageal reflux was more frequent after secondary RGYB-43.75% versus 25%, P < 0.05.","['patients treated with secondary Roux-en-Y gastric bypass (RYGB) after adjustable gastric banding (AGB) or vertical banded gastroplasty (VBG) with those of patients having primary RYGB', 'Patients undergoing secondary RYGB after AGB or VBG between 1997 and 2004 with a minimal follow-up of 15\xa0years were matched using a propensity score (according to gender, age, BMI, duration of follow-up) with comparable patients who underwent primary RYGB']",['Secondary Roux-en-Y Gastric Bypass'],"['Late postoperative complications and additional surgical procedures', 'Weight Loss', 'Quality of life-Morehead-Ardelt II score', 'Early postoperative complications rate', 'Gastroesophageal reflux', 'general self-assessment of health status and weight satisfaction', 'weight loss, GERD remission and energy expenditure', 'Remission of obesity-related comorbidities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1960832', 'cui_str': 'Partitioning of stomach using band'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0017193', 'cui_str': 'Gastroplasty'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",,0.0211827,"Gastroesophageal reflux was more frequent after secondary RGYB-43.75% versus 25%, P < 0.05.","[{'ForeName': 'Jean Hubert', 'Initials': 'JH', 'LastName': 'Etienne', 'Affiliation': 'Digestive Surgery and Liver Transplantation Unit, Centre Hospitalier Universitaire de Nice, Archet II Hospital, Nice, 151 Route Saint Antoine de Ginestière, BP 3079, Nice Cedex 3, France.'}, {'ForeName': 'Niccolo', 'Initials': 'N', 'LastName': 'Petrucciani', 'Affiliation': 'Digestive Surgery and Liver Transplantation Unit, Centre Hospitalier Universitaire de Nice, Archet II Hospital, Nice, 151 Route Saint Antoine de Ginestière, BP 3079, Nice Cedex 3, France.'}, {'ForeName': 'Mailys', 'Initials': 'M', 'LastName': 'Goetschy', 'Affiliation': 'Institute of Demography, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gugenheim', 'Affiliation': 'Digestive Surgery and Liver Transplantation Unit, Centre Hospitalier Universitaire de Nice, Archet II Hospital, Nice, 151 Route Saint Antoine de Ginestière, BP 3079, Nice Cedex 3, France.'}, {'ForeName': 'Anne Sophie', 'Initials': 'AS', 'LastName': 'Schneck', 'Affiliation': 'Digestive Surgery Unit, Centre Hospitalier Universitaire de Guadeloupe, Pointe-à Pitre, Les Abymes, Guadeloupe, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Iannelli', 'Affiliation': 'Digestive Surgery and Liver Transplantation Unit, Centre Hospitalier Universitaire de Nice, Archet II Hospital, Nice, 151 Route Saint Antoine de Ginestière, BP 3079, Nice Cedex 3, France. iannelli.a@chu-nice.fr.'}]",Obesity surgery,['10.1007/s11695-020-04728-5']
3438,32488754,Effects of isoflavones on bone turnover markers in peritoneal dialysis patients: a randomized controlled trial.,"PURPOSE
The aim of this study was to investigate the effects of soy isoflavones on serum markers of bone formation and resorption in peritoneal dialysis (PD) patients.
METHODS
In this randomized, double-blind, placebo-controlled trial, 40 PD patients were randomly assigned to either the soy isoflavone or the placebo group. The patients in the soy isoflavone group received 100 mg soy isoflavones daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of the 8th week, 7 ml of blood was obtained from each patient after a 12- to 14-h fast and serum concentrations of bone formation markers (osteocalcin and bone alkaline phosphatase), bone resorption markers [N-telopeptide and receptor activator of nuclear factor kappa B ligand (RANKL)], and osteoprotegerin as an inhibitor of bone resorption were measured.
RESULTS
Serum N-telopeptide concentration decreased significantly up to 27% in the soy isoflavone group at the end of week 8 compared to baseline (P = 0.003). Also, serum RANKL concentration reduced significantly up to 17% in the soy isoflavone group at the end of week 8 compared to baseline (P = 0.03). These bone resorption markers did not significantly change in the placebo group during the study. There were no significant differences between the two groups in mean changes of serum osteocalcin, bone alkaline phosphatase, and osteoprotegerin.
CONCLUSION
This study indicates that daily administration of 100 mg soy isoflavone supplement to PD patients reduces serum N-telopeptide and RANKL which are two bone resorption markers. CLINICALTRIALS.GOV: NCT03773029, 2018.",2020,"There were no significant differences between the two groups in mean changes of serum osteocalcin, bone alkaline phosphatase, and osteoprotegerin.
","['peritoneal dialysis (PD) patients', 'peritoneal dialysis patients', '40 PD patients']","['isoflavones', 'placebos', '100\xa0mg soy isoflavone supplement', 'soy isoflavone', '100\xa0mg soy isoflavones', 'soy isoflavones', 'placebo']","['serum N-telopeptide', 'Serum N-telopeptide concentration', 'serum markers of bone formation and resorption', 'serum concentrations of bone formation markers (osteocalcin and bone alkaline phosphatase), bone resorption markers [N-telopeptide and receptor activator of nuclear factor kappa B ligand (RANKL)], and osteoprotegerin as an inhibitor of bone resorption', 'bone turnover markers', 'bone resorption markers', 'serum RANKL concentration', 'serum osteocalcin, bone alkaline phosphatase, and osteoprotegerin']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C1868869', 'cui_str': 'N-telopeptide serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0666361', 'cui_str': 'TNFSF11 protein, human'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",40.0,0.271872,"There were no significant differences between the two groups in mean changes of serum osteocalcin, bone alkaline phosphatase, and osteoprotegerin.
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Tabibi', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, 46, West Arghavan St., Farahzadi Blvd., Shahrak Qods, P. O. Box 19395-4741, Tehran, Islamic Republic of Iran. hadtabibi@yahoo.com.'}, {'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Najafi', 'Affiliation': 'Department of Nephrology, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Movahedian', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran.'}]",International urology and nephrology,['10.1007/s11255-020-02523-w']
3439,32488793,"Associations Between Gender, Resiliency Factors, and Anxiety in Neuro-ICU Caregivers: a Prospective Study.","BACKGROUND
Informal caregivers of patients admitted to the neuroscience intensive care unit (Neuro-ICU) are at risk for developing chronic anxiety. Resiliency factors may reduce risk, yet their differential effects for female and male caregivers have not been studied in this population. We aim to examine interactions between gender and baseline resiliency factors and anxiety at baseline, 3 months, and 6 months.
METHOD
Prospectively studied caregivers (N = 96) of patients admitted to the Neuro-ICU completed baseline sociodemographics and resiliency measures (coping, mindfulness, self-efficacy, intimate care, and caregiver preparedness), and anxiety severity at baseline (hospitalization), 3 months, and 6 months.
RESULTS
Baseline anxiety predicted future anxiety (3 and 6 months). Caregivers who reported high (versus low) baseline coping, mindfulness, self-efficacy, and preparedness for caregiving reported lower baseline anxiety (ps ≤ 0.012). An interaction between caregiver gender and baseline mindfulness was seen at 3 months (p = 0.021), with high mindfulness males reporting lower anxiety than high mindfulness females, and low mindfulness males reporting higher anxiety than low mindfulness females.
CONCLUSION
Results emphasize the protective role of resilience in the trajectory of anxiety among informal caregivers. Findings emphasize the need to rapidly deploy skills-based treatment to Neuro-ICU caregivers to prevent future development and maintenance of anxiety, specifically emphasizing mindfulness in male caregivers.",2020,"An interaction between caregiver gender and baseline mindfulness was seen at 3 months (p = 0.021), with high mindfulness males reporting lower anxiety than high mindfulness females, and low mindfulness males reporting higher anxiety than low mindfulness females.
","['Informal caregivers of patients admitted to the neuroscience intensive care unit (Neuro-ICU', 'Prospectively studied caregivers (N\u2009=\u200996) of patients admitted to the Neuro-ICU completed baseline sociodemographics and resiliency measures (coping, mindfulness, self-efficacy, intimate care, and caregiver preparedness), and anxiety severity at baseline (hospitalization), 3\xa0months, and 6\xa0months', 'female and male caregivers', 'male caregivers']",[],[],"[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],[],,0.0243065,"An interaction between caregiver gender and baseline mindfulness was seen at 3 months (p = 0.021), with high mindfulness males reporting lower anxiety than high mindfulness females, and low mindfulness males reporting higher anxiety than low mindfulness females.
","[{'ForeName': 'Ethan G', 'Initials': 'EG', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA.'}, {'ForeName': 'Ilyssa H', 'Initials': 'IH', 'LastName': 'Silverman', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Gates', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA. avranceanu@mgh.harvard.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09907-3']
3440,32489001,Effects of lingual exercises on oral muscle strength and salivary flow rate in elderly adults: a randomized clinical trial.,"AIM
The present study investigated the effects of two types of lingual exercise (tongue-hold swallowing and tongue-pressure resistance training) on oral muscle strength, salivary flow rate and subjective oral health of the elderly.
METHODS
We randomly assigned 74 elderly adults (≥65 years) to three groups (tongue-hold swallowing, tongue-pressure resistance training and control groups). Each group participated in 8 weeks of their appropriately prescribed intervention. We measured anterior tongue strength, posterior tongue strength, lip strength, salivary flow rate and Oral Health Impact Profile-14 score before and after 8 weeks. Differences before and after intervention were observed with a paired sample t-test. Moreover, analyses of covariance and variance were performed to determine the differences in the measured values between the groups.
RESULTS
The tongue-hold swallowing group showed improvement in both anterior and posterior tongue strength, while the tongue-pressure resistance training group showed a significant increase in only anterior tongue strength. Both the tongue-hold swallowing and tongue-pressure resistance training groups showed increased salivary secretion, with the tongue-pressure resistance training group showing a higher level of salivary secretion. However, the difference in the subjective oral health scores before and after the intervention was not significant.
CONCLUSIONS
The two lingual exercises strengthened some aspects of tongue muscles and increased the salivary flow rate, with more salivary secretion in the tongue-pressure resistance training group than in the tongue-hold swallowing group. Any evidence of the lingual exercises being able to enhance subjective oral health could not be found. Geriatr Gerontol Int 2020; ••: ••-••.",2020,"Both the tongue-hold swallowing and tongue-pressure resistance training groups showed increased salivary secretion, with the tongue-pressure resistance training group showing a higher level of salivary secretion.","['74 elderly adults (≥65\u2009years) to three groups ', 'elderly adults']","['tongue-hold swallowing, tongue-pressure resistance training', 'lingual exercises', 'lingual exercise (tongue-hold swallowing and tongue-pressure resistance training']","['anterior tongue strength, posterior tongue strength, lip strength, salivary flow rate and Oral Health Impact Profile-14 score', 'anterior tongue strength', 'subjective oral health scores', 'oral muscle strength and salivary flow rate', 'anterior and posterior tongue strength', 'salivary flow rate', 'oral muscle strength, salivary flow rate and subjective oral health of the elderly', 'salivary secretion']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0226945', 'cui_str': 'Structure of body of tongue'}, {'cui': 'C0226958', 'cui_str': 'Structure of root of tongue'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0036104', 'cui_str': 'Salivary secretion'}]",74.0,0.0292108,"Both the tongue-hold swallowing and tongue-pressure resistance training groups showed increased salivary secretion, with the tongue-pressure resistance training group showing a higher level of salivary secretion.","[{'ForeName': 'Kyeong-Hee', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Dental Hygiene, College of Bioecological Health, Shinhan University, Uijeongbu, Republic of Korea.'}, {'ForeName': 'Eun-Seo', 'Initials': 'ES', 'LastName': 'Jung', 'Affiliation': 'Department of Dental Hygiene, College of Bioecological Health, Shinhan University, Uijeongbu, Republic of Korea.'}, {'ForeName': 'Yoon-Young', 'Initials': 'YY', 'LastName': 'Choi', 'Affiliation': 'Artificial Intelligence Big Data Medical Center, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.'}]",Geriatrics & gerontology international,['10.1111/ggi.13944']
3441,32489005,Effectiveness of a self-regulation intervention for weight loss: A randomized controlled trial.,"OBJECTIVES
To evaluate effectiveness and acceptability of a novel intervention, based on self-regulation theory, for weight loss.
DESIGN
A two-arm parallel group design was employed.
METHODS
Adult participants with a BMI ≥ 30 kg/m 2 and the aim to lose weight were recruited and randomized to either a control or intervention group. Both groups were asked to weigh themselves daily for eight weeks. The intervention group was encouraged to use a weight tracking app, and complete daily and weekly questionnaires to prompt action planning, reflection, and evaluation of actions. Participants chose daily actions from a menu of 53 behaviours. The primary outcome was weight change after 8 weeks, assessed using linear mixed effects models. At follow-up, 20 intervention group participants were interviewed regarding their experiences in the trial.
RESULTS
100 participants were recruited, and 98% were followed up at 8 weeks. Mean weight loss was -4.18 kg (SD = 3.84) in the intervention compared to -1.01 kg (SD = 2.67) in the control group; the adjusted difference was -3.20 kg (95% CI -4.49, -1.92). Participants rated the intervention's usefulness as 8.25 (SD = 2.04) on a scale from 1 to 10. Adherence was a significant independent predictor of weight loss success (-1.54 kg per one SD, 95% CI -2.16, -0.93), but not a mediator of the intervention effect. Participants reported that the intervention enabled them to experiment with and identify effective weight loss actions.
CONCLUSIONS
Guiding participants through the self-regulation process was feasible, acceptable to participants, and led to significantly greater short-term weight loss than unguided self-weighing.",2020,"Adherence was a significant independent predictor of weight loss success (-1.54 kg per one SD, 95% CI -2.16, -0.93), but not a mediator of the intervention effect.","['Adult participants with a BMI\xa0≥', '100 participants were recruited, and 98% were followed up at 8\xa0weeks', '30\xa0kg/m 2 and the aim to lose weight']",['self-regulation intervention'],"['weight loss', 'Mean weight loss', 'weight loss success', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",100.0,0.142796,"Adherence was a significant independent predictor of weight loss success (-1.54 kg per one SD, 95% CI -2.16, -0.93), but not a mediator of the intervention effect.","[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Frie', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hartmann-Boyce', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}]",British journal of health psychology,['10.1111/bjhp.12436']
3442,32489115,The Use of Eye Tracking to Discern the Threshold at Which Metopic Orbitofrontal Deformity Attracts Attention.,"INTRODUCTION AND OBJECTIVES
Surgical treatment for trigonocephaly aims to eliminate a stigmatizing deformity, yet the severity that captures unwanted attention is unknown. Surgeons intervene at different points of severity, eliciting controversy. This study used eye tracking to investigate when deformity is perceived.
MATERIAL AND METHODS
Three-dimensional photogrammetric images of a normal child and a child with trigonocephaly were mathematically deformed, in 10% increments, to create a spectrum of 11 images. These images were shown to participants using an eye tracker. Participants' gaze patterns were analyzed, and participants were asked if each image looked ""normal"" or ""abnormal.""
RESULTS
Sixty-six graduate students were recruited. Average dwell time toward pathologic areas of interest (AOIs) increased proportionally, from 0.77 ± 0.33 seconds at 0% deformity to 1.08 ± 0.75 seconds at 100% deformity ( P < .0001). A majority of participants did not agree an image looked ""abnormal"" until 90% deformity from any angle.
CONCLUSION
Eye tracking can be used as a proxy for attention threshold toward orbitofrontal deformity. The amount of attention toward orbitofrontal AOIs increased proportionally with severity. Participants did not generally agree there was ""abnormality"" until deformity was severe. This study supports the assertion that surgical intervention may be best reserved for more severe deformity.",2020,"Average dwell time toward pathologic areas of interest (AOIs) increased proportionally, from 0.77 ± 0.33 seconds at 0% deformity to 1.08 ± 0.75 seconds at 100% deformity ( P < .0001).","['Sixty-six graduate students', 'Participants\' gaze patterns were analyzed, and participants were asked if each image looked ""normal"" or ""abnormal', 'Three-dimensional photogrammetric images of a normal child and a child with trigonocephaly were mathematically deformed, in 10% increments, to create a spectrum of 11 images']",[],"['amount of attention toward orbitofrontal AOIs', 'Average dwell time toward pathologic areas of interest (AOIs']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0265535', 'cui_str': 'Trigonocephaly'}]",[],"[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}]",,0.068858,"Average dwell time toward pathologic areas of interest (AOIs) increased proportionally, from 0.77 ± 0.33 seconds at 0% deformity to 1.08 ± 0.75 seconds at 100% deformity ( P < .0001).","[{'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Pressler', 'Affiliation': 'Department of Plastic Surgery, UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Geisler', 'Affiliation': 'Department of Plastic Surgery, UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Rami R', 'Initials': 'RR', 'LastName': 'Hallac', 'Affiliation': 'Department of Plastic Surgery, UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Seaward', 'Affiliation': 'Department of Plastic Surgery, UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Kane', 'Affiliation': 'Department of Plastic Surgery, UT Southwestern, Dallas, TX, USA.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665620926014']
3443,32485993,"Acute and Chronic Effects of Green Oat ( Avena sativa) Extract on Cognitive Function and Mood during a Laboratory Stressor in Healthy Adults: A Randomised, Double-Blind, Placebo-Controlled Study in Healthy Humans.","Green oat ( Avena sativa ) extracts contain several groups of potentially psychoactive phytochemicals. Previous research has demonstrated improvements in cognitive function following a single dose of these extracts, but not following chronic supplementation. Additionally, whilst green oat extracts contain phytochemicals that may improve mood or protect against stress, for instance species-specific triterpene saponins, to date this possibility has not been examined. The current study investigated the effects of a single dose and four weeks of administration of a novel, Avena sativa herbal extract (cognitaven ® ) on cognitive function and mood, and changes in psychological state during a laboratory stressor. The study adopted a dose-ranging, double-blind, randomised, parallel groups design in which 132 healthy males and females (35 to 65 years) received either 430 mg, 860 mg, 1290 mg green oat extract or placebo for 29 days. Assessments of cognitive function, mood and changes in psychological state during a laboratory stressor (Observed Multitasking Stressor) were undertaken pre-dose and at 2 h and 4 h post-dose on the first (Day 1) and last days (Day 29) of supplementation. The results showed that both a single dose of 1290 mg and, to a greater extent, supplementation for four weeks with both 430 mg and 1290 mg green oat extract resulted in significantly improved performance on a computerised version of the Corsi Blocks working memory task and a multitasking task (verbal serial subtractions and computerised tracking) in comparison to placebo. After four weeks, the highest dose also decreased the physiological response to the stressor in terms of electrodermal activity. There were no treatment-related effects on mood. These results confirm the acute cognitive effects of Avena sativa extracts and are the first to demonstrate that chronic supplementation can benefit cognitive function and modulate the physiological response to a stressor.",2020,"After four weeks, the highest dose also decreased the physiological response to the stressor in terms of electrodermal activity.","['Healthy Humans', '132 healthy males and females (35 to 65 years', 'Healthy Adults']","['Placebo', 'Green oat ( Avena sativa ) extracts', 'novel, Avena sativa herbal extract (cognitaven ® ', 'green oat extract or placebo', 'Green Oat ( Avena sativa) Extract', 'placebo']","['physiological response', 'cognitive function', 'performance on a computerised version of the Corsi Blocks working memory task and a multitasking task (verbal serial subtractions and computerised tracking', 'cognitive function and mood, and changes in psychological state', 'cognitive function, mood and changes in psychological state', 'Cognitive Function and Mood']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0939905', 'cui_str': 'Oats preparation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C1364956', 'cui_str': 'Oat extract'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}]",132.0,0.197591,"After four weeks, the highest dose also decreased the physiological response to the stressor in terms of electrodermal activity.","[{'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Kennedy', 'Affiliation': 'Brain, Performance and Nutrition Research Centre, Northumbria University, Newcastle-upon-Tyne NE1 8ST, UK.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Bonnländer', 'Affiliation': 'Anklam Extrakt GmbH, Marienbergstr. 92, 90411 Nuremberg, Germany.'}, {'ForeName': 'Stefanie C', 'Initials': 'SC', 'LastName': 'Lang', 'Affiliation': 'Anklam Extrakt GmbH, Marienbergstr. 92, 90411 Nuremberg, Germany.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Pischel', 'Affiliation': 'Research Group Pharmacognosy and Phytotherapy, UCL School of Pharmacy, London WC1N 1AX, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Forster', 'Affiliation': 'Brain, Performance and Nutrition Research Centre, Northumbria University, Newcastle-upon-Tyne NE1 8ST, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': 'Brain, Performance and Nutrition Research Centre, Northumbria University, Newcastle-upon-Tyne NE1 8ST, UK.'}, {'ForeName': 'Philippa A', 'Initials': 'PA', 'LastName': 'Jackson', 'Affiliation': 'Brain, Performance and Nutrition Research Centre, Northumbria University, Newcastle-upon-Tyne NE1 8ST, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Wightman', 'Affiliation': 'NUTRAN, Northumbria University, Newcastle NE1 8ST, UK.'}]",Nutrients,['10.3390/nu12061598']
3444,32486385,A Phase 1 Study of mTORC1/2 Inhibitor BI 860585 as a Single Agent or with Exemestane or Paclitaxel in Patients with Advanced Solid Tumors.,"This phase 1 trial (NCT01938846) determined the maximum tolerated dose (MTD) of the mTOR serine/threonine kinase inhibitor, BI 860585, as monotherapy and with exemestane or paclitaxel in patients with advanced solid tumors. This 3+3 dose-escalation study assessed BI 860585 monotherapy (5-300 mg/day; Arm A), BI 860585 (40-220 mg/day; Arm B) with 25 mg/day exemestane, and BI 860585 (80-220 mg/day; Arm C) with 60-80 mg/m 2 /week paclitaxel, in 28-day cycles. Primary endpoints were the number of patients with dose-limiting toxicities (DLTs) in cycle 1 and the MTD. Forty-one, 25, and 24 patients were treated (Arms A, B, and C). DLTs were observed in four (rash ( n = 2), elevated alanine aminotransferase/aspartate aminotransferase, diarrhea), four (rash ( n = 3), stomatitis, and increased gamma-glutamyl transferase), and two (diarrhea, increased blood creatine phosphokinase) patients in cycle 1. The BI 860585 MTD was 220 mg/day (Arm A) and 160 mg/day (Arms B and C). Nine patients achieved an objective response (Arm B: Four partial responses (PRs); Arm C: Four PRs; one complete response). The disease control rate was 20%, 28%, and 58% (Arms A, B, and C). The most frequent treatment-related adverse events (AEs) were hyperglycemia (54%) and diarrhea (39%) (Arm A); diarrhea (40%) and stomatitis (40%) (Arm B); fatigue (58%) and diarrhea (58%) (Arm C). The MTD was determined in all arms. Antitumor activity was observed with BI 860585 monotherapy and in combination with exemestane or paclitaxel.",2020,The most frequent treatment-related adverse events (AEs) were hyperglycemia (54%) and diarrhea (39%),"['Patients with Advanced Solid Tumors', 'patients with advanced solid tumors']","['Exemestane or Paclitaxel', 'exemestane or paclitaxel', 'exemestane', 'week paclitaxel']","['diarrhea', 'disease control rate', 'Antitumor activity', 'elevated alanine aminotransferase/aspartate aminotransferase, diarrhea), four (rash ( n = 3), stomatitis, and increased gamma-glutamyl transferase), and two (diarrhea, increased blood creatine phosphokinase', 'objective response', 'number of patients with dose-limiting toxicities (DLTs) in cycle 1 and the MTD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0853165', 'cui_str': 'Blood creatine phosphokinase'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}]",860585.0,0.0390057,The most frequent treatment-related adverse events (AEs) were hyperglycemia (54%) and diarrhea (39%),"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Medical Oncology Department, University of Milan, via G. Venezian, 1, 20133 Milan, Italy.'}, {'ForeName': 'Jean-Pascal H', 'Initials': 'JH', 'LastName': 'Machiels', 'Affiliation': ""Institut Roi Albert II, Service d'Oncologie Médicale, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université Catholique de Louvain, Avenue Hippocrate 10, 200 Woluwe-Saint-Lambert, 1200 Brussels, Belgium.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Boggiani', 'Affiliation': 'Medical Oncology Unit, University Hospital of Parma, Via Antonio Gramsci 14, 43126 Parma, Italy.'}, {'ForeName': 'Sylvie W H', 'Initials': 'SWH', 'LastName': 'Rottey', 'Affiliation': 'Drug Research Unit Ghent, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Duca', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, via G. Venezian, 1, 20133 Milan, Italy.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Laruelle', 'Affiliation': 'Institut Roi Albert II, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université catholique de Louvain, Avenue Hippocrate 10, 200 Woluwe-Saint-Lambert, 1200 Brussels, Belgium.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Salvagni', 'Affiliation': 'Policlinico S. Orsola Malphigi, via Giuseppe Massarenti, 13, 40138 Bologna, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Damian', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, via G. Venezian, 1, 20133 Milan, Italy.'}, {'ForeName': 'Lore D F', 'Initials': 'LDF', 'LastName': 'Lapeire', 'Affiliation': 'Drug Research Unit Ghent, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tiseo', 'Affiliation': 'Medical Oncology Unit, University Hospital of Parma, Via Antonio Gramsci 14, 43126 Parma, Italy.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dermine', 'Affiliation': 'Institut Roi Albert II, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université catholique de Louvain, Avenue Hippocrate 10, 200 Woluwe-Saint-Lambert, 1200 Brussels, Belgium.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Ould-Kaci', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd, Ridgefield, CT 06877, USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Braunger', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riß, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Rascher', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riß, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riß, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Hoefler', 'Affiliation': 'Staburo GmbH, Aschauer Str. 26b, 81549 Munich, Germany, on behalf of Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Gabriella L', 'Initials': 'GL', 'LastName': 'Mariani', 'Affiliation': 'Boehringer Ingelheim, via Giovanni Lorenzini, 8, 20139 Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cresta', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, via G. Venezian, 1, 20133 Milan, Italy.'}]",Cancers,['10.3390/cancers12061425']
3445,32486583,[Efficacy and safety of levosimendan in elderly patients with severe heart failure].,"Objective: To investigate the efficacy and safety of different dosage regimens of levosimendan in elderly patients with severe heart failure. Methods: Thirty-two patients 75 years or older were randomly divided into a loading dose group (16 cases) in which levosimendan was maintained at 0.1 μg·kg(-1)·min(-1) for 24 h after loaded with 6 μg/kg, and a maintenance dose group (16 cases) with same schedule without loading dose. The amino-terminal brain natriuretic peptide (NT-proBNP) before and after treatment was detected. Left ventricular ejection fraction (LVEF), stroke volume (SV), stroke volume index (SVI) by echocardiograph were monitored. Adverse events, the length of stay in ICU and 28-day mortality were recorded. Results: The NT-proBNP level in loading group after treatment was 1 950 (922,6 481)ng/L, which was improved than that before treatment [4 018(2 716,9 637)ng/L, P <0.05]. The result was similar in maintenance group [1 390 (599,3 297)ng/L vs. 4 576 (2 681,10 682)ng/L, P <0.05]. LVEF in loading group before and after treatment was (39.4±8.8) % vs. (48.9±9.2) % respectively, while in maintenance group it was (40.4±8.8) % vs. (48.7±12.0) % (both P <0.05). SV were also improved after treatment in both groups compared with baseline levels ( P <0.05). NT-proBNP started to decline on day 3 in the loading group, while on day 7 in the maintenance group. SVI recovered on day 14 in the loading group [ (29.4±6.5) ml/m(2) vs. (27.3±6.7) ml/m(2), P <0.05], while it did not change much in the maintenance group. There was no significant differences as to the length of stay in ICU [ (11.1±4.4) d in loading group vs. (9.6±3.5) d in maintenance group] and 28-day mortality rates were comparable (2/16 in loading group vs. 1/16 in maintenance group) . The adverse events were 7 vs. 2 cases in loading group and maintenance group respectively, which were mild and all alleviated. Conclusion: The application of levosimendan only with maintenance dose improves cardiac function in very elderly patients with severe heart failure. Adverse events are mild and manageable.",2020,"NT-proBNP started to decline on day 3 in the loading group, while on day 7 in the maintenance group.","['Methods: Thirty-two patients 75 years or older', 'elderly patients with severe heart failure', 'very elderly patients with severe heart failure']","['levosimendan', 'LVEF']","['Adverse events, the length of stay in ICU and 28-day mortality', 'SVI', 'efficacy and safety', 'SV', 'cardiac function', 'Left ventricular ejection fraction (LVEF), stroke volume (SV), stroke volume index (SVI', 'adverse events', 'length of stay in ICU', '28-day mortality rates', 'NT-proBNP level']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0432178,"NT-proBNP started to decline on day 3 in the loading group, while on day 7 in the maintenance group.","[{'ForeName': 'Y B', 'Initials': 'YB', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Yu', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Gong', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}]",Zhonghua nei ke za zhi,['10.3760/cma.j.cn112138-20190827-00587']
3446,32486622,"The effectiveness of interprofessional education programs for medical, nursing, and pharmacy students.","PURPOSE
This study is to develop an interprofessional education (IPE) program for medical, nursing, and pharmacy students and to analyze the effectiveness.
METHODS
Subjects consisted of 116 students (41 medical, 46 nursing, and 29 pharmacy students) enrolled in their final year. Subjects were randomly assigned to either the intervention group or the control group, with 58 in each group. A pretest-posttest control group design was used. The program was operated for a single day, and consisted of small-group activities and role-play. We utilized the following tools: Perceptions towards Interprofessional Education (PIPE), Self-Efficacy for Interprofessional Experiential Learning (SEIEL), and Perception towards Interprofessional Competency (PIC). We used t-test and analysis of covariance for analysis.
RESULTS
The PIPE tool revealed that the scores of the intervention group were significantly higher than those of the control group (p=0.000). The result was the same when the scores were categorized into the groups medical students (p=0.001), nursing students (p=0.000), and pharmacy students (p=0.005). The SEIEL study also indicated the intervention group scored significantly higher than the control group (p=0.000). However, pharmacy students did not reveal significant (p=0.983). The intervention group scored significantly higher than the control group in the PIC. A concluding survey of the intervention group indicated that most students were satisfied with the IPE program.
CONCLUSION
We hope this study will provide useful information for designing and improving IPE programs in other universities.",2020,The SEIEL study also indicated the intervention group scored significantly higher than the control group (p=0.000).,"['medical, nursing, and pharmacy students', 'Subjects consisted of 116 students (41 medical, 46 nursing, and 29 pharmacy students) enrolled in their final year']","['interprofessional education programs', 'Interprofessional Experiential Learning (SEIEL), and Perception towards Interprofessional Competency (PIC']",[],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",[],116.0,0.0181828,The SEIEL study also indicated the intervention group scored significantly higher than the control group (p=0.000).,"[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Department of Urology, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Kwi Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Medical Education, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Yul Ha', 'Initials': 'YH', 'LastName': 'Min', 'Affiliation': 'Gachon University College of Nursing, Incheon, Korea.'}, {'ForeName': 'Eunhee', 'Initials': 'E', 'LastName': 'Ji', 'Affiliation': 'Gachon University College of Pharmacy, Incheon, Korea.'}]",Korean journal of medical education,['10.3946/kjme.2020.161']
3447,32486840,Impact of a Personalized Audit and Feedback Intervention on Antibiotic Prescribing Practices for Outpatient Pediatric Community-Acquired Pneumonia.,"Antibiotic choice for pediatric community-acquired pneumonia (CAP) varies widely. We aimed to determine the impact of a 6-month personalized audit and feedback program on primary care providers' antibiotic prescribing practices for CAP. Participants in the intervention group received monthly personalized feedback. We then analyzed enrolled providers' CAP antibiotic prescribing practices. Participants diagnosed 316 distinct cases of CAP (214 control, 102 intervention); among these 316 participants, 301 received antibiotics (207 control, 94 intervention). In patients ≥5 years, the intervention group had fewer non-guideline-concordant antibiotics prescribed (22/103 [21.4%] control; 3/51 [5.9%] intervention, P < .05) and received more of the guideline-concordant antibiotics (amoxicillin and azithromycin). Personalized, scheduled audit and feedback in the outpatient setting was feasible and had a positive impact on clinician's selection of guideline-recommended antibiotics. Audit and feedback should be combined with other antimicrobial stewardship interventions to improve guideline adherence in the management of outpatient CAP.",2020,"In patients ≥5 years, the intervention group had fewer non-guideline-concordant antibiotics prescribed (22/103 [21.4%] control; 3/51 [5.9%] intervention, P < .05) and received more of the guideline-concordant antibiotics (amoxicillin and azithromycin).","['Participants diagnosed 316 distinct cases of CAP (214 control, 102 intervention); among these 316 participants, 301 received antibiotics (207 control, 94 intervention', 'pediatric community-acquired pneumonia (CAP', ""primary care providers' antibiotic prescribing practices for CAP"", ""enrolled providers' CAP antibiotic prescribing practices"", 'Outpatient Pediatric Community-Acquired Pneumonia']","['antibiotics (amoxicillin and azithromycin', 'monthly personalized feedback', 'personalized audit and feedback program', 'antimicrobial stewardship interventions', 'Personalized Audit and Feedback Intervention']","['fewer non-guideline-concordant antibiotics', 'guideline adherence']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}]",316.0,0.0337686,"In patients ≥5 years, the intervention group had fewer non-guideline-concordant antibiotics prescribed (22/103 [21.4%] control; 3/51 [5.9%] intervention, P < .05) and received more of the guideline-concordant antibiotics (amoxicillin and azithromycin).","[{'ForeName': 'Maria Carmen G', 'Initials': 'MCG', 'LastName': 'Diaz', 'Affiliation': 'Nemours/Alfred I. du Pont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Lori K', 'Initials': 'LK', 'LastName': 'Handy', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Crutchfield', 'Affiliation': 'Lockheed-Martin Corporation, Orlando, FL, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Cadilla', 'Affiliation': ""Nemours Children's Hospital, Orlando, FL, USA.""}, {'ForeName': 'Jobayer', 'Initials': 'J', 'LastName': 'Hossain', 'Affiliation': 'Nemours/Alfred I. du Pont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Lloyd N', 'Initials': 'LN', 'LastName': 'Werk', 'Affiliation': ""Nemours Children's Hospital, Orlando, FL, USA.""}]",Clinical pediatrics,['10.1177/0009922820928054']
3448,32487150,"Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study.","BACKGROUND
Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC.
METHODS
This proof-of-concept, prospective, randomized controlled trial commenced in Japan in March 2018. Initially, a questionnaire-based survey will be conducted targeting adult patients with cancer who concomitantly commenced opioid treatment and OIC prevention treatment. Patients will then be randomly allocated to a magnesium oxide group (500 mg thrice daily) or a naldemedine group (0.2 mg once daily). Each drug will be orally administered for 12 weeks. The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment.
DISCUSSION
The primary endpoint is change in JPAC-QOL score from baseline to 2 weeks of intervention. The key secondary endpoint will be change in spontaneous bowel movements at 2 and 12 weeks of intervention. This study will determine whether magnesium oxide or naldemedine is more effective for the prevention of OIC.
TRIAL REGISTRATION
University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000031891. Registered March 25, 2018.",2020,"The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment.
","['adult patients with cancer who concomitantly commenced opioid treatment and OIC prevention treatment', 'opioid-induced constipation', 'Japan in March 2018']","['magnesium oxide with naldemedine', 'magnesium oxide and naldemedine', 'magnesium oxide', 'naldemedine', 'magnesium oxide or naldemedine']","['Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL', 'change in JPAC-QOL score', 'spontaneous bowel movements']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}]","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",,0.135076,"The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ozaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yoshihara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology, International University of Health and Welfare Atami Hospital, 13-1 Higashikaigan-cho, Atami, 413-0012, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Taguri', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ishiki', 'Affiliation': 'Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Noritoshi', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Oncology, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Palliative Care Center, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. nakajima-tky@umin.ac.jp.'}]",Trials,['10.1186/s13063-020-04385-0']
3449,32487157,The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population.,"BACKGROUND
Smartphone-based support can reach thousands of smokers and help those who would otherwise try to quit smoking by themselves with little chance of success. Nicotine medications double the chances of quitting smoking, but few smokers use them, and they often use them for too short a time and at an insufficient dose. It is therefore important to increase access to support for smoking cessation and compliance with nicotine therapy. The objectives of this study are to assess whether the Stop-Tabac application (app) is effective for smoking cessation and to examine whether the outcome is influenced by the personal characteristics of participants.
METHODS
Trial design: this is a two-arm, parallel-group, superiority, individually randomized, ""placebo"" controlled trial in 5200 smokers, with follow up after 1 week, 1 month and 6 months. The participants are adult daily smokers (N = 5200) enrolled on the Internet, living in France or Switzerland. The intervention is the Stop-tabac fully-automated app for smartphones, which was launched in 2012 and continuously improved thereafter. It includes fact sheets; calculators of cigarettes not smoked, money saved, and years of life gained; an interactive ""coach"" that provides automated, individually tailored counseling messages based on the user's personal profile, sent regularly for 6 months; immediate feedback during episodes of craving and tobacco withdrawal symptoms; a discussion forum (""The Tribe"") where participants provide and receive social support; a quiz that informs users in a playful way; and a module on nicotine therapy that includes personalized feedback and follow up. The outcome is self-reported smoking cessation after 6 months (no puff of tobacco in the past 4 weeks), and after 1 week and 1 month (no puff in the past 7 days). Participants will be randomized automatically based on a list of random numbers. Participants, assistants in charge of collecting follow-up data and data analysts will be blinded to allocation. Funding is provided by the Swiss National Science Foundation, CHF 194,942 (EUR 182,200, USD 200,700), grant 32003_179369. JFE's salary is paid by the University of Geneva, YK's salary is paid by the Lausanne University Hospitals.
DISCUSSION
There is little evidence from randomized trials of the impact of health apps in general and of smoking cessation apps in particular. This study will fill this gap.
TRIAL REGISTRATION
ISRCTN Registry: ISRCTN11318024. Registered on 17 May 2018.",2020,"The objectives of this study are to assess whether the Stop-Tabac application (app) is effective for smoking cessation and to examine whether the outcome is influenced by the personal characteristics of participants.
","['5200 smokers', 'participants are adult daily smokers (N\u2009=\u20095200) enrolled on the Internet, living in France or Switzerland']","['nicotine therapy', 'Nicotine medications', 'Stop-Tabac application (app', 'placebo']","['self-reported smoking cessation', 'chances of quitting smoking']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0045439', 'cui_str': '2,4,6-triiodo-3-acetamidobenzoic acid (N-cyclohexylcarbamyloxy)ethyl ester'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",5200.0,0.11621,"The objectives of this study are to assess whether the Stop-Tabac application (app) is effective for smoking cessation and to examine whether the outcome is influenced by the personal characteristics of participants.
","[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Etter', 'Affiliation': 'Institute of Global Health, Faculty of Medicine, University of Geneva, 9 chemin des Mines, Campus Biotech, CH-1202, Geneva, Switzerland. Jean-Francois.Etter@unige.ch.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Khazaal', 'Affiliation': 'Addiction Medicine, Department of Psychiatry, Lausanne University Hospital and Lausanne University, Lausanne, Switzerland.'}]",Trials,['10.1186/s13063-020-04377-0']
3450,32487163,Study of Medical Ultrasound for Rhizarthrosis (SUR): study protocol for a randomized controlled single-center pilot-trial.,"BACKGROUND
Rhizarthrosis (trapeziometacarpal osteoarthritis) is the second most common site of osteoarthritis in the hand affecting 10-30% of adults over the age of 50. Up to four times as many women as men have rhizarthrosis. Clinical symptoms include functional disability of the thumb, pain, joint swelling, and reduced strength. The first carpometacarpal joint is pivotal in the opposition of the thumb and allows a high degree in flexibility to humans. Current therapies focus mainly on surgical strategies, which should be considered in advanced, therapy-resistant stages to relieve pain and improve function. However, conservative treatment methods are urgently required in presurgical stages. The efficacy of conservative treatment options for rhizarthrosis, which are intended to preserve function, joint integrity and to relieve pain, has not been adequately studied. In the clinical study protocol presented here, we investigate the efficacy of multimodal hand therapy versus therapeutic ultrasound versus combination therapy with both hand therapy and therapeutic ultrasound.
METHODS
This study is a single-center, randomized, controlled, parallel-group pilot trial. One hundred fifty patients with rhizarthrosis and current disease activity will be randomized to one of three conservative interventions over 6 months. Interventions are (1) multimodal hand therapy (2) therapeutic ultrasound, and (3) combination therapy with both hand therapy and ultrasound therapy. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score after 6 months. Secondary endpoints are changes in pain, quality of life, disability progression, and changes of hand function. Safety will also be assessed.
DISCUSSION
Clinical data suggest that multimodal hand therapy may improve functionality and reduce pain in rhizarthrosis. Clinical data regarding therapeutic ultrasound are not available. Clinical evidence is lacking. This study is the first clinical study investigating the effects of multimodal hand therapy in direct comparison to therapeutic ultrasound and to a combination therapy with both hand therapy and ultrasound therapy for rhizarthrosis.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT04115085; Registered on September 30, 2019.",2020,"The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score after 6 months.",['One hundred fifty patients with rhizarthrosis and current disease activity'],"['Medical Ultrasound for Rhizarthrosis (SUR', 'multimodal hand therapy', 'multimodal hand therapy (2) therapeutic ultrasound, and (3) combination therapy with both hand therapy and ultrasound therapy', 'multimodal hand therapy versus therapeutic ultrasound versus combination therapy']","['functional disability of the thumb, pain, joint swelling, and reduced strength', 'changes in pain, quality of life, disability progression, and changes of hand function', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328502', 'cui_str': 'Rhizarthrosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1328502', 'cui_str': 'Rhizarthrosis'}, {'cui': 'C0038944', 'cui_str': 'Suriname'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0230377', 'cui_str': 'Both hands'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",150.0,0.0513211,"The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score after 6 months.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bock', 'Affiliation': 'Department of Hand Surgery, Upper Extremity and Foot Surgery, Center for Orthopedics and Trauma Surgery, Hospital Waldfriede, Argentinische Allee 40, 14163, Berlin, Germany. m.bock@waldfriede.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eisenschenk', 'Affiliation': 'Department of Hand and Functional Microsurgery, University Medicine Greifswald, Ferdinand-Sauerbruch-Str. 1, 17475, Greifswald, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Lorenzen', 'Affiliation': 'Department of Hand Surgery, Upper Extremity and Foot Surgery, Center for Orthopedics and Trauma Surgery, Hospital Waldfriede, Argentinische Allee 40, 14163, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lautenbach', 'Affiliation': 'Department of Hand Surgery, Upper Extremity and Foot Surgery, Center for Orthopedics and Trauma Surgery, Hospital Waldfriede, Argentinische Allee 40, 14163, Berlin, Germany.'}]",Trials,['10.1186/s13063-020-04375-2']
3451,32487179,The ACCEPT-study: design of an RCT with an active treatment control condition to study the effectiveness of the Dutch version of PEERS® for adolescents with autism spectrum disorder.,"BACKGROUND
Social skills interventions are commonly deployed for adolescents with autism spectrum disorder (ASD). Because effective and appropriate social skills are determined by cultural factors that differ throughout the world, the effectiveness of these interventions relies on a good cultural fit. Therefore, the ACCEPT study examines the effectiveness of the Dutch Program for the Education and Enrichment of Relational Skills (PEERS®) social skills intervention.
METHODS/DESIGN
This study is a two-arm parallel group randomized controlled trial (RCT) in which adolescents are randomly assigned (after baseline assessment) to one of two group interventions (PEERS® vs. active control condition). In total, 150 adolescents are to be included, with multi-informant involvement of their parents and teachers. The ACCEPT study uses an active control condition (puberty psychoeducation group training, focussing on social-emotional development) and explores possible moderators and mediators in improving social skills. The primary outcome measure is the Contextual Assessment of Social Skills (CASS). The CASS assesses social skills performance in a face to face social interaction with an unfamiliar, typically developing peer, making this a valuable instrument to assess the social conversational skills targeted in PEERS®. In addition, to obtain a complete picture of social skills, self-, parent- and teacher-reported social skills are assessed using the Social Skills improvement System (SSiS-RS) and Social Responsiveness Scale (SRS-2). Secondary outcome measures (i.e. explorative mediators) include social knowledge, social cognition, social anxiety, social contacts and feelings of parenting competency of caregivers. Moreover, demographic and diagnostic measures are assessed as potential moderators of treatment effectiveness. Assessments of adolescents, parents, and teachers take place at baseline (week 0), intermediate (week 7), post intervention (week 14), and at follow-up (week 28).
CONCLUSION
This is the first RCT on the effectiveness of the PEERS® parent-assisted curriculum which includes an active control condition. The outcome of social skills is assessed using observational assessments and multi-informant questionnaires. Additionally, factors related to social learning are assessed at several time points, which will enable us to explore potential mediators and moderators of treatment effect.
TRAIL REGISTRATION
Dutch trail register NTR6255 (NL6117). Registered February 8th, 2017 - retrospectively registered.",2020,"Therefore, the ACCEPT study examines the effectiveness of the Dutch Program for the Education and Enrichment of Relational Skills (PEERS®) social skills intervention.
","['adolescents with autism spectrum disorder', 'adolescents with autism spectrum disorder (ASD', '150 adolescents are to be included, with multi-informant involvement of their parents and teachers']","['RCT', 'Dutch version of PEERS®', 'active control condition (puberty psychoeducation group training, focussing on social-emotional development', 'group interventions (PEERS® vs. active control condition']","['social skills performance', 'social skills, self-, parent- and teacher-reported social skills', 'Social Skills improvement System (SSiS-RS) and Social Responsiveness Scale (SRS-2', 'social skills', 'social knowledge, social cognition, social anxiety, social contacts and feelings of parenting competency of caregivers', 'Contextual Assessment of Social Skills (CASS']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0292637,"Therefore, the ACCEPT study examines the effectiveness of the Dutch Program for the Education and Enrichment of Relational Skills (PEERS®) social skills intervention.
","[{'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'van Pelt', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands. b.vanpelt@erasmusmc.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Idris', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jagersma', 'Affiliation': 'Yulius Organization for Mental Health, Burg, De Raadtsingel 93c, 3311, JG, Dordrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Duvekot', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Yulius Organization for Mental Health, Burg, De Raadtsingel 93c, 3311, JG, Dordrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Ende', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'N E M', 'Initials': 'NEM', 'LastName': 'van Haren', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Greaves-Lord', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-02650-9']
3452,32487264,Natural outcome of hemoglobin and functional recovery after the direct anterior versus the posterolateral approach for total hip arthroplasty: a randomized study.,"BACKGROUND
Total hip arthroplasty (THA) is one of the most successful orthopedic surgeries. There are many common surgical approaches for THA. The direct anterior approach (DAA) and posterolateral approach (PLA) were compared, leading to controversial results.
METHODS
We report on a prospective randomized study which compared the changes of perioperative hemoglobin (Hb), the Harris hip score (HHS) and a visual analog scale (VAS) pain score following THA using DAA or PLA. A total of 130 participants were randomly divided into two groups (65 DAA versus 65 PLA). Perioperative ΔHb and other clinical outcomes were recorded.
RESULTS
A total of 130 participants completed follow-up, while 14 patients were not recorded in blood outcomes due to blood transfusions and complications. The average Hb decrease immediately after surgery in the DAA group was greater than that in the PLA group (21.1 versus 15.8 g/L, P < .001). However, post-operative Hb descent velocity was slower in the DAA group, and the lowest point was reached earlier. No significant differences in ΔHb levels could be observed after 1 month in the two groups. When compared with the PLA group, the DAA group had a shorter incision (9.1 versus 13.5 cm, P < .001) and shorter hospital stay (4.2 versus 4.7 days, P = .004). However, the operation time of the DAA group was longer (88.0 versus 66.8 min, P < .001). The DAA group had a better HHS and VAS pain score at 6 weeks post-surgery. However, no significant differences were observed at later time points.
CONCLUSION
We concluded that DAA performed better on enhanced recovery after surgery (ERAS) than PLA in THA, while both DAA and PLA could result in a positive, similar result after 3 months.
TRIAL REGISTRATION
The study was registered by the Chinese Clinical Trial Registry (ChiCTR1900020770, 19 January 2019).",2020,"When compared with the PLA group, the DAA group had a shorter incision (9.1 versus 13.5 cm, P < .001) and shorter hospital stay (4.2 versus 4.7 days, P = .004).","['A total of 130 participants', 'total hip arthroplasty']","['DAA', 'direct anterior approach (DAA) and posterolateral approach (PLA', 'PLA', 'direct anterior versus the posterolateral approach', 'THA using DAA or PLA', 'Total hip arthroplasty (THA']","['blood outcomes due to blood transfusions and complications', 'shorter incision', 'shorter hospital stay', 'ΔHb levels', 'post-operative Hb descent velocity', 'hemoglobin and functional recovery', 'perioperative hemoglobin (Hb), the Harris hip score (HHS) and a visual analog scale (VAS) pain score', 'HHS and VAS pain score', 'operation time']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",130.0,0.0832761,"When compared with the PLA group, the DAA group had a shorter incision (9.1 versus 13.5 cm, P < .001) and shorter hospital stay (4.2 versus 4.7 days, P = .004).","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Yiqin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xin', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China. lother@163.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China. wangbo229000@sina.com.'}, {'ForeName': 'Qirong', 'Initials': 'Q', 'LastName': 'Qian', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China. qianqr@163.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01716-4']
3453,32487334,Dexamethasone eardrop with grommet placement vs intratympanic steroid injection for sudden sensorineural hearing loss: A randomized prospective clinical trial.,"OBJECTIVES
The purpose of this study was to compare different means of intratympanic steroid delivery in the treatment of idiopathic sudden sensorineural hearing loss.
DESIGN
Prospective, multicentered, randomized controlled trial.
SETTING AND PARTICIPANTS
Fifty-six patients who fulfilled the inclusion criteria for idiopathic sudden sensorineural hearing loss who failed or were contraindicated for oral steroids were included in this study. Patients were randomly divided into 2 groups according to delivery methods: group A received 4 sections of intratympanic dexamethasone injection and group B received grommet placement with dexamethasone delivery followed by 3 sections of dexamethasone ear drop application. Self-administered paper-based questionnaires were filled out to measure subjective pain scores, vertigo, anxiety, and overall satisfaction immediately after each procedure. Hearing threshold was measured with pure tone audiogram in the follow-up.
RESULTS
There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30). Grommet placement followed by dexamethasone eardrop application demonstrated a significant difference in shorter waiting time (24 min in grommet group vs 52 min in injection group; P < 0.01); and better overall satisfaction (1.6 in grommet group vs 2.5 in injection group; P < 0.05).
CONCLUSIONS
Grommet placement followed by dexamethasone eardrop application is a good alternative for a patient indicated for intratympanic steroid, with less administrative cost, shorter waiting time, and more satisfaction.",2020,There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30).,"['sudden sensorineural hearing loss', 'Fifty-six patients who fulfilled the inclusion criteria for idiopathic sudden sensorineural hearing loss who failed or were contraindicated for oral steroids were included in this study', 'idiopathic sudden sensorineural hearing loss']","['Dexamethasone eardrop with grommet placement vs intratympanic steroid injection', '4 sections of intratympanic dexamethasone injection and group B received grommet placement with dexamethasone delivery followed by 3 sections of dexamethasone ear drop application', 'intratympanic steroid delivery']","['subjective pain scores, vertigo, anxiety, and overall satisfaction', 'overall satisfaction', 'shorter waiting time', 'hearing threshold improvement']","[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C4283889', 'cui_str': 'Dexamethasone Injection'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1154187', 'cui_str': 'Ear drops'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",56.0,0.0352837,There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30).,"[{'ForeName': 'Wai Tsz', 'Initials': 'WT', 'LastName': 'Chang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong. Electronic address: waitsz@ent.cuhk.edu.hk.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Zee', 'Affiliation': 'School of Public Health, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Herbert S H', 'Initials': 'HSH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong. Electronic address: herbertshlee@gmail.com.'}, {'ForeName': 'Michael C F', 'Initials': 'MCF', 'LastName': 'Tong', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102515']
3454,32487336,Echinacea can help with Azithromycin in prevention of recurrent tonsillitis in children.,"PURPOSE
Recurrent tonsillitis in children is a common disease affecting children quality of life and extends to their families. The aim of this study was to assess the effect of combined use of oral Azithromycin (AZT) plus Echinacea compared to exclusive use of AZT in children with recurrent tonsillitis.
MATERIAL AND METHODS
A prospective comparative study including three groups of children with recurrent tonsillitis. Group 1: (100 patients) had no prophylactic treatment. Group 2 (100 patients) received [60 mg/kg] prophylactic dose of AZT divided as (10 mg/kg/day) over 6 consecutive days every month for 6 consecutive months. Group 3 (100 patients) received AZT as in group 2 plus commercially available Echinacea in a dose of 5 ml oral suspension; 3 times daily for 10 consecutive days every month for 6 consecutive months. Number of tonsillitis attacks and severity of tonsillitis symptoms were assessed and compared in different groups.
RESULTS
Group 2 and group 3 had significant less number of tonsillitis attacks and severity of assessed symptoms during 6 months of prophylactic treatment with significant better results in group 3 (i.e. AZT plus Echinacea) compared to group 2 (I.e. AZT alone). However; there was no significant difference in patients with any prophylaxis.
CONCLUSION
The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.",2019,The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.,"['pediatric patients with recurrent tonsillitis', 'children with recurrent tonsillitis', 'children']","['AZT as in group 2 plus commercially available Echinacea in a dose of 5\u202fml oral suspension', 'Azithromycin', 'AZT', 'oral Azithromycin (AZT) plus Echinacea']","['Number of tonsillitis attacks and severity of tonsillitis symptoms', 'tonsillitis attacks and severity of assessed symptoms']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740402', 'cui_str': 'Tonsillitis recurrent'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0752270', 'cui_str': 'Echinacea Preparation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0991537', 'cui_str': 'Oral suspension'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.0177451,The combined use of Echinacea with Azithromycin produced favorable outcome than Azithromycin alone in pediatric patients with recurrent tonsillitis.,"[{'ForeName': 'Osama G', 'Initials': 'OG', 'LastName': 'Abdel-Naby Awad', 'Affiliation': 'Otolaryngology, Head and Neck Department, Minia University Hospital, 122 Kornish El-Neel Street, Minia City, Minia, Egypt. Electronic address: Usama.abdelnabi@mu.edu.eg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2019.102344']
3455,32487465,Medial temporal lobe cortical changes in response to exercise interventions in people with early psychosis: A randomized controlled trial.,"OBJECTIVE
Individuals with early psychosis may have prefrontal-limbic cortical deficits, which are associated with symptom severity and cognitive impairment. This study investigated the impact of an exercise intervention on fronto-temporal cortical plasticity in female participants with early psychosis.
METHODS
In a cohort of 51 female participants with early psychosis from Hong Kong, we investigated the effects of a 12-week, moderate intensity aerobic or Hatha yoga exercise trial (yoga (N = 21), aerobic (N = 18) or waitlist group (N = 12)) on cortical grey matter. Clinical assessments and structural MRI were completed pre- and post- a 12-week exercise intervention.
RESULTS
Increases in cortical volume and thickness were observed in the medial temporal cortical regions, primarily in fusiform cortical thickness (F(2, 48) = 4.221, p = 0.020, η 2 = 0.150) and volume (F(2, 48) = 3.521, p = 0.037, η 2 = 0.128) for participants with early psychosis in the aerobic arm, but not in the yoga and waitlist arms. Increased fusiform cortical thickness (ß = 0.402, p = 0.003) was associated with increased hippocampal volume for all psychosis participants. For the aerobic group only, increases in the entorhinal and fusiform temporal gyri were associated with reduced symptom severity.
CONCLUSIONS
These findings suggest exercise-induced neuroplasticity in medial temporal cortical regions occurs with aerobic exercise. These changes may be associated with improvements in psychosis symptom severity. People with early psychosis may benefit from exercise interventions, particularly aerobic exercise, as an adjunct treatment to address clinical, physical health, and neuroanatomic concerns. NIH National Library of Medicine ClinicalTrials.gov Registration #: NCT01207219https://clinicaltrials.gov/ct2/show/NCT01207219.",2020,"For the aerobic group only, increases in the entorhinal and fusiform temporal gyri were associated with reduced symptom severity.
","['Individuals with early psychosis', 'people with early psychosis', 'female participants with early psychosis', 'People with early psychosis', '51 female participants with early psychosis from Hong Kong']","['moderate intensity aerobic or Hatha yoga exercise trial (yoga (N\xa0=\xa021), aerobic (N\xa0=\xa018) or waitlist group (N\xa0=\xa012)) on cortical grey matter', 'exercise interventions', 'exercise intervention']","['hippocampal volume', 'Increased fusiform cortical thickness', 'medial temporal cortical regions, primarily in fusiform cortical thickness (F(2, 48)\xa0', 'psychosis symptom severity', 'cortical volume and thickness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332493', 'cui_str': 'Fusiform shape'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",51.0,0.148747,"For the aerobic group only, increases in the entorhinal and fusiform temporal gyri were associated with reduced symptom severity.
","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Woodward', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Canada.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Gicas', 'Affiliation': 'Department of Psychology, York University, Canada.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Canada.'}, {'ForeName': 'Christy L M', 'Initials': 'CLM', 'LastName': 'Hui', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Honer', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Canada.'}, {'ForeName': 'Eric Y H', 'Initials': 'EYH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Donna J', 'Initials': 'DJ', 'LastName': 'Lang', 'Affiliation': 'Department of Radiology, University of British Columbia, Canada. Electronic address: dlang@mail.ubc.ca.'}]",Schizophrenia research,['10.1016/j.schres.2020.05.043']
3456,32487838,Participation in a System-Thinking Simulation Experience Changes Adverse Event Reporting.,"INTRODUCTION
System failures are contributing factors in the thousands of adverse events occurring in US healthcare institutions yearly. This study explored the premise that exposure to a simulation experience designed to improve system thinking (ST) would impact adverse event reporting patterns.
METHODS
An intervention-control study was used to explore impacts of participation in a simulation designed to improve ST on adverse event reporting. Each summer Bachelor in Nursing Science students along with medical students participate in a week-long simulation-based interprofessional patient safety course. During the 2017 course, Friday Night in the ER, a table-top simulation designed to develop ST was included. As part of the school nursing's simulation program, students are asked to report adverse events observed or committed during simulation encounters into a simulated adverse event reporting system outside the simulation-based interprofessional patient safety course. Adverse event reporting system data were used to examine patterns of adverse event reporting in control and intervention groups studied.
RESULTS
Findings demonstrated differences in proportions of reported adverse events. The proportion of reported adverse events by students with the second and terminal semesters of course work combined and the 2016 and 2018 control groups combined demonstrated statistically significant differences, P < 0.001. Additional analysis revealed that the intervention group reported more medication-related events, whereas the control group reported more failure to rescue and airway-related events.
CONCLUSIONS
Exposure to a simulation designed to develop ST seems to impact adverse event reporting. These findings support the idea that ST may change safety monitoring behaviors.",2020,An intervention-control study was used to explore impacts of participation in a simulation designed to improve ST on adverse event reporting.,[],[],"['proportion of reported adverse events', 'adverse events', 'failure to rescue and airway-related events']",[],[],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0198418,An intervention-control study was used to explore impacts of participation in a simulation designed to improve ST on adverse event reporting.,"[{'ForeName': 'Jill S', 'Initials': 'JS', 'LastName': 'Sanko', 'Affiliation': 'From the University of Miami School of Nursing and Health Studies, Coral Gables, FL.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Mckay', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000473']
3457,32487881,Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial.,"OBJECTIVES
The primary objective of this study is to compare patient versus physician rankings of adverse event (AE) and adverse symptom (AS) severity after pelvic reconstructive surgery. Secondary objectives include to estimate the association between patient rankings of AEs/ASs with decision-making and quality-of-life outcomes and to determine whether patient perspective about AE/AS changes over time.
METHODS
This is a supplementary study, Patient-Perspectives in Adverse Event Reporting (PPAR), to the index trial, ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design). During the trial, AEs/ASs will be assessed by physicians longitudinally every 6 months, which includes a determination of the AE/AS grade severity. For PPAR, additional patient perspective will be measured for 19 predetermined AEs/ASs at the time of identification and again at 12 and 36 months postoperatively. Decision-making and quality-of-life questionnaires will be collected at these time points. The primary outcome, the overall interrater agreement between patient and physician rankings for AE/AS severity, will be determined using a repeated-measures concordance correlation coefficient.
RESULTS
To date, the index trial has completed enrollment, and follow-up is ongoing.
CONCLUSIONS
The PPAR methods for incorporating patient perspective in the measurement of AEs/ASs to determine their agreement with physician ranking, long-term relevance, and impact on treatment decision making and quality of life are described. This will contribute to improved measurements of AEs/ASs in future research with the goal of improving patient counseling and informing expectations and treatment decision making.",2020,"The primary outcome, the overall interrater agreement between patient and physician rankings for AE/",['after pelvic reconstructive surgery'],['ASPIRe (Apical Suspension Repair for Vault Prolapse'],"['patient rankings of AEs/ASs with decision-making and quality-of-life outcomes', 'overall interrater agreement between patient and physician rankings for AE', 'adverse event (AE) and adverse symptom (AS) severity', 'Decision-making and quality-of-life questionnaires', 'patient perspective about AE/AS changes over time']","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}]","[{'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0324145', 'cui_str': 'Equus asinus'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.128049,"The primary outcome, the overall interrater agreement between patient and physician rankings for AE/","[{'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'From the Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Menefee', 'Affiliation': 'Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Reproductive Medicine, UC San Diego Health System, San Diego, CA.'}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Dunivan', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Moalli', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Weidner', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Uduak Umoh', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania Health System, Philadelphia, PA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jelovsek', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Whitworth', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000845']
3458,32487916,Effects of Adding Oxycodone to Ropivacaine on Labor Analgesia: A Randomized Controlled Trial: Erratum.,,2020,,[],"['Oxycodone', 'Ropivacaine']",['Labor Analgesia'],[],"[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}]",,0.180916,,[],The Clinical journal of pain,['10.1097/AJP.0000000000000836']
3459,32487971,"Effects of trunk stabilization exercise while wearing a pelvic compression belt on walking and balancing abilities in patients whit stroke: an assessor blinded, preliminary, randomized, controlled study.","OBJECTIVE
To investigate the effects of wearing a pelvic compression belt during trunk stability exercise on balance and gait ability in patients with stroke.
DESIGN
Thirty-six patients with stroke participated and were randomly allocated to three groups: the paretic group (trunk stability exercise wearing a pelvic belt on paretic side), the non-paretic group (trunk stability exercise wearing a pelvic belt on non-paretic side), or the control group (trunk stability exercise without a pelvic belt). Walking and balancing abilities were assessed before and after trunk stabilization exercise.
RESULTS
Significantly larger gains were identified in the paretic group than in the control group for all variables (p < .017). In addition, significantly larger gains were observed in the paretic group than in the non-paretic group (p < .017)(limit of stability, 15.6%; stance phase of paretic side, 4.1%; 10 m walking test, -10.1%; 6 minutes walking test, 4.6%).
CONCLUSION
Wearing a pelvic belt on the paretic side during trunk stabilization exercise appears to be more effective at improving the balancing and walking abilities of patients with stroke than wearing a pelvic compression belt on the non-paretic side or not wearing a pelvic belt.",2020,Significantly larger gains were identified in the paretic group than in the control group for all variables (p < .017).,"['patients whit stroke', 'Thirty-six patients with stroke participated', 'patients with stroke']","['wearing a pelvic compression belt during trunk stability exercise', 'paretic group (trunk stability exercise wearing a pelvic belt on paretic side), the non-paretic group (trunk stability exercise wearing a pelvic belt on non-paretic side), or the control group (trunk stability exercise without a pelvic belt', 'trunk stabilization exercise']","['walking and balancing abilities', 'Walking and balancing abilities', 'larger gains', 'balance and gait ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",36.0,0.0276591,Significantly larger gains were identified in the paretic group than in the control group for all variables (p < .017).,"[{'ForeName': 'Yoon-Hee', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. E-mail: aldlsdbsl@naver.com Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. E-mail: kimnan1004@hanmail.net Department of Physical Therapy, College of Health and Medical Science, Cheongju University, Republic of Korea. E-mail: rhdrns1111@naver.com Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. E-mail: cha0874@gmail.com.'}, {'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Son', 'Affiliation': ''}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001484']
3460,32487982,Oxidative stress does not influence weight loss induced by aerobic training in adults: randomized clinical trials.,"BACKGROUND
High levels of oxidative stress promote degradation of the cell membrane impairing cellular function in fat oxidation. However, the influence of oxidative stress on exercise-induced weight-loss has not yet been investigated. Therefore, the aim of this study was to verify the influence of a lipidic peroxidation marker (malondialdehyde, MDA) and antioxidant status (total antioxidant capacity marker, TAC) on the magnitude of weight-loss by aerobic-induced exercise in previously sedentary overweight or obese individuals.
METHODS
Seventy-five physically inactive adults were randomized into experimental (N.=58) and control (N.=17) groups, who engaged in a 12-week program of aerobic training walking and/or running (3 to 5 days/week) or stretching (1 day/week), respectively. Body composition (DXA), aerobic capacity (ergospirometric) and blood collections for oxidative stress analysis (MDA and TAC) were determined before and after the experimental protocol. Two-way ANOVA for repeated measures or Friedman's test were used to evaluate differences in time/group interaction. Pearson correlation was used to verify the relationship between the variables of oxidative stress and of body composition.
RESULTS
Significant reduction was found in fat body mass of experimental when compared to control group (-1.3±1.9 kg versus -0.3±1.3, P=0.04). Experimental group also altered significantly the total body mass (-1.2±4.7 kg; effect size 0.44), body mass index - BMI (-0.3±1.1 effect size 0.37), fat percentage (1.3±1.6%; effect size 0.50) and lean body mass (0.6±1.5 kg; effect size 0.32).There was increase in MDA of 2.3 μmol/L to 2.7 μmol/L (P=0.00), without changes to TAC (25.6±13.9% to 28.0±10.4%). No correlation was found between these variations in body composition with either the initial values of MDA and TAC or delta variation of these indicators of oxidative stress in response to the training program.
CONCLUSIONS
Indicators of oxidative stress (MDA and TAC) does not influence the magnitude of weight-loss induced by aerobic training.",2020,"CONCLUSIONS
Indicators of oxidative stress (MDA and TAC) does not influence the magnitude of weight-loss induced by aerobic training.","['Seventy-five physically inactive adults', 'adults', 'previously sedentary overweight or obese individuals']","['aerobic training walking and/or running', 'aerobic training', 'aerobic-induced exercise']","['weight-loss', 'Body composition (DXA), aerobic capacity (ergospirometric) and blood collections for oxidative stress analysis (MDA and TAC', 'fat body mass', 'total body mass', 'lipidic peroxidation marker (malondialdehyde, MDA) and antioxidant status (total antioxidant capacity marker, TAC', 'lean body mass', 'body mass index - BMI', 'weight loss', 'MDA', 'fat percentage']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0015665', 'cui_str': 'Fat Body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",75.0,0.0300175,"CONCLUSIONS
Indicators of oxidative stress (MDA and TAC) does not influence the magnitude of weight-loss induced by aerobic training.","[{'ForeName': 'Glêbia A', 'Initials': 'GA', 'LastName': 'Cardoso', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Mateus D', 'Initials': 'MD', 'LastName': 'Ribeiro', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Ferreira', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Yohanna', 'Initials': 'Y', 'LastName': 'de Oliveira', 'Affiliation': 'Federal University of Paraíba (PPGCN/UFPB), João Pessoa, PB, Brazil.'}, {'ForeName': 'Thiago de O', 'Initials': 'TO', 'LastName': 'Medeiros', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'de Sousa', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Reabias de A', 'Initials': 'RA', 'LastName': 'Pereira', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Antônio E', 'Initials': 'AE', 'LastName': 'de Almeida', 'Affiliation': 'Lauro Wanderley University Hospital - HULW-Federal University of Paraíba - UFPB, João Pessoa, PB, Brazil.'}, {'ForeName': 'João M', 'Initials': 'JM', 'LastName': 'Filho', 'Affiliation': 'Lauro Wanderley University Hospital - HULW-Federal University of Paraíba - UFPB, João Pessoa, PB, Brazil.'}, {'ForeName': 'Raquel S', 'Initials': 'RS', 'LastName': 'Brito Silva', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Alexandre S', 'Initials': 'AS', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil - alexandresergiosilva@yahoo.com.br.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10528-0']
3461,32489498,Evaluation of bispectral index monitoring efficacy in endoscopic patients who underwent retrograde cholangiopancreatography and received sedoanalgesia.,"Introduction
Bispectral index (BIS) monitoring provides an objective, non-invasive measurement of the level of consciousness in a sedated patient.
Aim
In this prospective study, we aimed to investigate the hypothesis that risk of respiratory depression could be reduced and the desired level of sedation with minimal doses of propofol could be achieved by using BIS monitoring in endoscopic retrograde cholangiopancreatography (ERCP) procedures.
Material and methods
Sixty patients in the ASA 1-2 category, who were scheduled for an ERCP with sedation, were randomly divided into two groups. The procedure was performed, and sedation was administered so that the patient's Ramsay Sedation Score (RSS) would be 4-5 in the first group (group 1) and the patient's BIS value would be 65-75 in the second group (group 2). Cardiopulmonary complications, the total duration of the procedure, and the total amount of propofol administered were recorded.
Results
The mean SpO 2 measurements at the third minute, fifth minute, and 10 th minute were higher in the BIS group (p < 0.001) (p < 0.05). The mean number of respirations during the third, fifth, 10 th , and 15 th minute of sedation was significantly higher in the RSS group than in the BIS group (p < 0.05). There was no difference between the groups in terms of recovery time, total propofol amount, and additional doses of bolus propofol.
Conclusions
BIS monitoring during sedation with propofol for ERCP did not reduce total propofol use, but it may be an efficient guide for the timing of additional dose administration, which could reduce the risk of respiratory depression, and it could be used safely as an objective method in the follow-up of level of sedation.",2020,"The mean SpO 2 measurements at the third minute, fifth minute, and 10 th minute were higher in the BIS group (p < 0.001) (p < 0.05).","['endoscopic patients who underwent', 'Material and methods\n\n\nSixty patients in the ASA 1-2 category, who were scheduled for an ERCP with sedation']","['retrograde cholangiopancreatography and received sedoanalgesia', 'propofol', 'Introduction\n\n\nBispectral index (BIS) monitoring', 'RSS']","['mean SpO 2 measurements', 'Ramsay Sedation Score (RSS', 'Cardiopulmonary complications, the total duration of the procedure, and the total amount of propofol', 'mean number of respirations', 'bispectral index monitoring efficacy', 'recovery time, total propofol amount, and additional doses of bolus propofol']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0330399,"The mean SpO 2 measurements at the third minute, fifth minute, and 10 th minute were higher in the BIS group (p < 0.001) (p < 0.05).","[{'ForeName': 'Ferda Yilmaz', 'Initials': 'FY', 'LastName': 'Inal', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Hayrettin', 'Initials': 'H', 'LastName': 'Daskaya', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Yadigar', 'Initials': 'Y', 'LastName': 'Yilmaz', 'Affiliation': 'Clinic of Anaesthesiology and Reanimation, Sultan Abdülhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Kocoglu', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey.'}]",Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques,['10.5114/wiitm.2020.93461']
3462,32489505,Treating Japanese Patients With Pembrolizumab for Platinum-Refractory Advanced Urothelial Carcinoma in Real-World Clinical Practice.,"Background
Since December 2017, pembrolizumab has been approved in Japan as a second-line treatment for radical unresectable urothelial carcinoma (UC) that has become exacerbated after chemotherapy by the international randomized phase 3 trial, KEYNOTE-045. The aim of this study was to evaluate the oncological efficacy and safety of pembrolizumab after failure of platinum-based chemotherapy in Japanese patients with advanced UC in real-world clinical practice.
Methods
A total of 34 patients who received pembrolizumab after the failure of platinum-based chemotherapy for advanced urothelial carcinoma at four institutions between January 2018 and August 2019 were retrospectively evaluated. In all patients, UC was histopathologically diagnosed, and disease progression after platinum-based chemotherapy was radiologically confirmed.
Results
The median follow-up period was 7.7 months. The objective response rate, median progression-free survival, and median overall survival were 20.6%, 3.3 months, and 11.7 months, respectively. Regarding the toxicities associated with pembrolizumab, adverse events (AEs) of any grade occurred in 61.8%, and grade 3 AEs occurred in 23.5%; grade ≥ 4 AEs did not occur in any patients. Univariate analyses revealed that the Eastern Cooperative Oncology Group Performance Status, neutrophil/lymphocyte ratio, liver metastases, and time from previous chemotherapy were prognostic variables. Multivariate analyses revealed that liver metastases (positive: hazard ratio, 4.23; 95% confidence interval, 1.48 - 12.08; P < 0.01) and time from previous chemotherapy (≥ 3 months: hazard ratio, 5.06; 95% confidence interval, 1.43 - 17.91; P = 0.01) were independent prognostic factors.
Conclusions
In this real-world clinical study, these findings concerning the efficacy and safety of pembrolizumab for advanced UC in Japanese patients were comparable to those of the open-label, international, phase 3 trial KEYNOTE-045. Liver metastases and time from previous chemotherapy were independent prognostic factors in the present study.",2020,"Multivariate analyses revealed that liver metastases (positive: hazard ratio, 4.23; 95% confidence interval, 1.48 - 12.08; P < 0.01) and time from previous chemotherapy (≥ 3 months: hazard ratio, 5.06; 95% confidence interval, 1.43 - 17.91; P = 0.01) were independent prognostic factors.
","['radical unresectable urothelial carcinoma (UC', 'Japanese patients with advanced UC in real-world clinical practice', 'Treating Japanese Patients With Pembrolizumab for Platinum-Refractory Advanced Urothelial Carcinoma', 'Japanese patients', '34 patients who received pembrolizumab after the failure of platinum-based chemotherapy for advanced urothelial carcinoma at four institutions between January 2018 and August 2019 were retrospectively evaluated']","['pembrolizumab', 'platinum-based chemotherapy']","['liver metastases', 'objective response rate, median progression-free survival, and median overall survival', 'neutrophil/lymphocyte ratio, liver metastases, and time', 'oncological efficacy and safety']","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",34.0,0.118868,"Multivariate analyses revealed that liver metastases (positive: hazard ratio, 4.23; 95% confidence interval, 1.48 - 12.08; P < 0.01) and time from previous chemotherapy (≥ 3 months: hazard ratio, 5.06; 95% confidence interval, 1.43 - 17.91; P = 0.01) were independent prognostic factors.
","[{'ForeName': 'Nobuki', 'Initials': 'N', 'LastName': 'Furubayashi', 'Affiliation': 'Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kuroiwa', 'Affiliation': 'Department of Urology, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Tokuda', 'Affiliation': 'Department of Urology, Saga-ken Medical Centre Koseikan, Saga, Japan.'}, {'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Tomoda', 'Affiliation': 'Department of Urology, Oita Prefectural Hospital, Oita, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Morokuma', 'Affiliation': 'Department of Urology, Saga-ken Medical Centre Koseikan, Saga, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Hori', 'Affiliation': 'Department of Urology, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.'}, {'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Negishi', 'Affiliation': 'Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kumagai', 'Affiliation': 'Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Motonobu', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}]",Journal of clinical medicine research,['10.14740/jocmr4162']
3463,32489539,Early Outcomes of Medial Pivot Total Knee Arthroplasty Compared to Posterior-Stabilized Design: A Randomized Controlled Trial.,"Backgroud
The indications for total knee arthroplasty (TKA) have been expanded to include younger, demanding patients. Some TKA patients expect a return to high-performance activities to restore optimum quality of life. The concept of the medial pivot (MP) TKA is that more natural knee kinematics can be achieved by altering the bearing design. In the present study, we compared the early outcomes of MP TKA with posterior-stabilized (PS) TKA in terms of patient-reported outcomes, function, and performance.
Methods
This randomized study was performed in a high volume joint replacement facility of a tertiary care military hospital. We enrolled 40 patients each in the MP group and PS group and assessed knee flexion, patient-reported outcome (new Knee Society Score [new KSS]), patient performance (Delaware Osteoarthritis Profile Score [DOPS]), and function (Forgotten Joint Score [FJS]) at 2 years after surgery.
Results
Compared to PS group patients, MP group patients had similar patient-reported outcomes assessed by new KSS (satisfaction, expectation, and activity scales) and FJS. MP knee patients had better performance in the timed up and go test ( p < 0.026) and self-paced walk test ( p < 0.002) of DOPS. The gain in knee flexion (9.3° ± 14°) compared to baseline was significantly greater in the PS group ( p < 0.013).
Conclusions
When assessed by DOPS, getting up from chair and walking speed were significantly better in MP knee patients than in PS knee patients. However, considering the predictable rollback ensured by cam and post, the PS knee produced better knee flexion. Despite these results, patients were equally satisfied with the two designs.",2020,MP knee patients had better performance in the timed up and go test ( p < 0.026) and self-paced walk test ( p < 0.002) of DOPS.,"['total knee arthroplasty (TKA', 'high volume joint replacement facility of a tertiary care military hospital']","['MP TKA with posterior-stabilized (PS) TKA', 'Medial Pivot Total Knee Arthroplasty Compared to Posterior-Stabilized Design']","['DOPS, getting up from chair and walking speed', 'new KSS (satisfaction, expectation, and activity scales) and FJS', 'knee flexion, patient-reported outcome (new Knee Society Score [new KSS]), patient performance (Delaware Osteoarthritis Profile Score [DOPS]), and function (Forgotten Joint Score [FJS', 'knee flexion', 'gain in knee flexion']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0185317', 'cui_str': 'Implantation of joint prosthesis'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522485', 'cui_str': 'Patient performance'}, {'cui': 'C0011198', 'cui_str': 'Delaware'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}]",40.0,0.100327,MP knee patients had better performance in the timed up and go test ( p < 0.026) and self-paced walk test ( p < 0.002) of DOPS.,"[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Kulshrestha', 'Affiliation': 'Department of Orthopaedics, Command Hospital, Chandigarh, India.'}, {'ForeName': 'Munish', 'Initials': 'M', 'LastName': 'Sood', 'Affiliation': 'Department of Orthopaedics, Command Hospital, Chandigarh, India.'}, {'ForeName': 'Sarang', 'Initials': 'S', 'LastName': 'Kanade', 'Affiliation': 'Department of Orthopaedics, Dr Shyama Prasad Mukherjee Hospital, Lucknow, India.'}, {'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopaedics and Joint Replacement, Command Hospital Air Force, Bengaluru, India.'}, {'ForeName': 'Barun', 'Initials': 'B', 'LastName': 'Datta', 'Affiliation': 'Department of Orthopaedics, Joint Replacement Centre, Army Hospital R & R, New Delhi, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Mittal', 'Affiliation': 'Department of Orthopaedics, Military Hospital, Kilkee, India.'}]",Clinics in orthopedic surgery,['10.4055/cios19141']
3464,32489643,"Safety, tolerability, and pharmacokinetics of the selective prostacyclin receptor agonist ralinepag in single and multiple dosing studies of an immediate-release oral formulation in healthy volunteers.","Ralinepag (APD811), an oral, potent, and selective prostacyclin receptor (IP) agonist is being developed for treatment of pulmonary arterial hypertension. Two, single-center, randomized, double-blind, placebo-controlled, Phase 1 studies (single ascending dose and multiple ascending dose) evaluated an oral immediate-release capsule formulation of ralinepag in healthy subjects. Blood samples assessed plasma pharmacokinetics and safety and tolerability data monitored adverse events, vital signs, laboratory findings, physical examination, and electrocardiograms. Eighty-two healthy subjects (single ascending dose ( n = 32) and multiple ascending dose ( n = 50)) completed the studies. No clinically significant safety issues were observed, except one serious adverse event of atrial fibrillation considered moderate in intensity. In the single ascending dose study, ralinepag was tolerated up to 100 µg (single dose), but not 200 µg due to nausea and vomiting. Dose proportional mean ralinepag plasma exposure measures were observed. Maximum plasma concentrations were reached within 1.0-1.5 h post-dose and mean terminal elimination half-life values from 20.5-26.4 h. In the multiple ascending dose study, ralinepag tolerability decreased with increasing QD or BID dose. Dose proportional steady-state plasma exposure measures were observed where evaluable, with mean steady-state peak-to-trough ratios ranging from 3.34-4.49 (QD dosing) and 1.95-2.36 (BID dosing). Mean effective half-life values ranged from 17.5-18.4 h, reflecting ∼1.7-fold (QD dosing) and ∼2.6-fold (BID dosing) accumulation in plasma exposure. Safety and tolerability of oral immediate-release ralinepag was generally consistent with expectations for this drug class, but more individualized dose escalation appears warranted. Ralinepag exhibited favorable pharmacokinetic properties, with BID dosing producing desired minimal steady-state peak-to-trough fluctuation. Overall, results supported further clinical investigation of ralinepag and guided development of an extended-release formulation to facilitate QD dosing.",2020,Maximum plasma concentrations were reached within 1.0-1.5 h post-dose and mean terminal elimination half-life values from 20.5-26.4 h.,"['Eighty-two healthy subjects (single ascending dose ( n \u2009=\u200932) and multiple ascending dose ( n \u2009=\u200950)) completed the studies', 'healthy volunteers', 'healthy subjects']","['oral immediate-release capsule formulation of ralinepag', 'Ralinepag (APD811), an oral, potent, and selective prostacyclin receptor (IP) agonist', 'placebo']","['ralinepag tolerability', 'Safety, tolerability, and pharmacokinetics', 'Safety and tolerability', 'Dose proportional steady-state plasma exposure measures', 'nausea and vomiting', 'plasma pharmacokinetics and safety and tolerability data monitored adverse events, vital signs, laboratory findings, physical examination, and electrocardiograms', 'Maximum plasma concentrations']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4508023', 'cui_str': 'ralinepag'}, {'cui': 'C4521473', 'cui_str': 'Prostacyclin receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4508023', 'cui_str': 'ralinepag'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",82.0,0.019365,Maximum plasma concentrations were reached within 1.0-1.5 h post-dose and mean terminal elimination half-life values from 20.5-26.4 h.,"[{'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Grundy', 'Affiliation': 'Nonclinical Development & Clinical Pharmacology Department, Arena Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'King', 'Affiliation': 'Nonclinical Development & Clinical Pharmacology Department, Arena Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Adams', 'Affiliation': 'Research Department, Arena Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Cabell', 'Affiliation': 'Clinical Development Department, Arena Pharmaceuticals, Inc., San Diego, CA, USA.'}]",Pulmonary circulation,['10.1177/2045894020922814']
3465,32489958,Thiamine for Prevention of Postoperative Delirium in Patients Undergoing Gastrointestinal Surgery: A Randomized Clinical Trial.,"Objective
Postoperative delirium is a common complication after gastrointestinal surgery that is associated with adverse outcomes. Thiamine is an essential cofactor for the glycolysis, oxidative metabolism, production of neurotransmitters in the crebs cycle. In this study, efficacy of thiamine was assessed as a preventive strategy of delirium in patients undergoing gastrointestinal surgery.
Methods
In this randomized clinical trial, 96 adult patients admitted to the intensive care unit (ICU) following gastrointestinal surgery were included. Patients were allocated to receive either 200 mg intravenous thiamine daily or an equal volume of 0.9% saline for 3 days. Delirium was evaluated twice daily based on the confusion assessment method-ICU. The incidence of postoperative delirium was considered as the primary outcome, and total analgesic use and ventilation days has been defined as secondary outcomes of the study.
Findings
The incidence rate of delirium was significantly lower in the thiamine group than the placebo group on the first day (8.3% vs. 25%; Odds ratio: 0.27 [95% confidence interval (CI): 0.08-0.92]; P= 0.026) and on the second day (4.2% vs. 20.8%; or: 0.16 [95% CI: 0.03-0.81]; P= 0.014). No adverse effect related to thiamine was detected during the study course.
Conclusion
Study results suggest that thiamine is a safe option for the prevention of postoperative delirium in patients after gastrointestinal surgery.",2020,The incidence rate of delirium was significantly lower in the thiamine group than the placebo group on the first day (8.3% vs. 25%; Odds ratio: 0.27 [95% confidence interval (CI): 0.08-0.92]; P= 0.026) and on the second day (4.2% vs. 20.8%; or: 0.16 [95% CI: 0.03-0.81]; P= 0.014).,"['96 adult patients admitted to the intensive care unit (ICU) following gastrointestinal surgery were included', 'Patients', 'Undergoing Gastrointestinal Surgery', 'patients undergoing gastrointestinal surgery', 'patients after gastrointestinal surgery']","['200 mg intravenous thiamine daily or an equal volume of 0.9% saline', 'thiamine', 'Thiamine', 'placebo']","['total analgesic use and ventilation days', 'incidence rate of delirium', 'postoperative delirium', 'Delirium', 'Postoperative Delirium']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",96.0,0.523103,The incidence rate of delirium was significantly lower in the thiamine group than the placebo group on the first day (8.3% vs. 25%; Odds ratio: 0.27 [95% confidence interval (CI): 0.08-0.92]; P= 0.026) and on the second day (4.2% vs. 20.8%; or: 0.16 [95% CI: 0.03-0.81]; P= 0.014).,"[{'ForeName': 'Rohollah', 'Initials': 'R', 'LastName': 'Moslemi', 'Affiliation': 'Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Intensive Care Unit, School of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Mehrabi', 'Affiliation': 'Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Niayesh', 'Initials': 'N', 'LastName': 'Mohebbi', 'Affiliation': 'Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of research in pharmacy practice,['10.4103/jrpp.JRPP_19_124']
3466,32487120,The long and winding road to happiness: A randomized controlled trial and cost-effectiveness analysis of a positive psychology intervention for lonely people with health problems and a low socio-economic status.,"BACKGROUND
Our objective was to evaluate the effectiveness and cost-effectiveness of the positive psychology intervention 'Happiness Route' compared to an active control condition in a vulnerable population with an accumulation of health and psychosocial problems.
METHODS
We conducted a randomized, single-blind, actively-controlled, parallel group study in seven municipalities in the Netherlands. To be eligible, participants had to experience loneliness, health problems and low socio-economic status. Each group received several home visits by a counsellor (two in the control condition, two to six in the experimental condition). In the Happiness Route, a happiness-based approach was used, whereas the control condition used a traditional problem-based approach. The primary outcome was well-being, measured with the Mental Health Continuum-Short Form (MHC-SF).
RESULTS
Fifty-eight participants were randomized to the Happiness Route, 50 to the control condition. Participants were severely lonely, had on average three health problems and less than 5% had paid work. The total MHC-SF score, emotional and social well-being, depression and loneliness improved significantly over the nine-month period in both conditions (p < .05), but there were no significant changes between the conditions across time. Languishing decreased significantly from 33% at baseline to 16% at follow-up among the Happiness Route participants but did not change significantly in the control condition. No significant improvement over time was found in psychological well-being, resilience, purpose in life, health-related quality of life and social participation. Cost-effectiveness analysis showed that expected saved costs per QALY lost was €219,948 for the Happiness Route, relative to the control condition. The probability was 83% that the Happiness Route was cost saving and 54% that the Happiness Route was cost-effective at a willingness to accept a threshold of €100,000.
CONCLUSIONS
Mental health status of both groups improved considerably. However, we could not demonstrate that the Happiness Route yielded better health outcomes compared to the control condition. Nevertheless, the results of the cost-effectiveness analysis suggested that the Happiness Route is an acceptable intervention from a health-economic point of view. Our results should be viewed in light of the fact that we could not include the planned number of participants.
TRIAL REGISTRATION
Netherlands Trial Register: NTR3377. Registered 2 Apr 2012.",2020,"No significant improvement over time was found in psychological well-being, resilience, purpose in life, health-related quality of life and social participation.","['Fifty-eight participants', 'participants had to experience loneliness, health problems and low socio-economic status', 'lonely people with health problems and a low socio-economic status', 'Participants were severely lonely, had on average three health problems and less than 5% had paid work', 'seven municipalities in the Netherlands']","['NTR3377', 'positive psychology intervention', ""positive psychology intervention 'Happiness Route""]","['total MHC-SF score, emotional and social well-being, depression and loneliness', 'psychological well-being, resilience, purpose in life, health-related quality of life and social participation', 'effectiveness and cost-effectiveness', 'well-being, measured with the Mental Health Continuum-Short Form (MHC-SF', 'health outcomes']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",58.0,0.0683567,"No significant improvement over time was found in psychological well-being, resilience, purpose in life, health-related quality of life and social participation.","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Weiss', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands. weiss.laura.a@gmail.com.'}, {'ForeName': 'Martijn A H', 'Initials': 'MAH', 'LastName': 'Oude Voshaar', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands.'}, {'ForeName': 'Gerben J', 'Initials': 'GJ', 'LastName': 'Westerhof', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01416-x']
3467,32487131,"Genetic basis for prediction of non-responders to dietary plant sterol intervention (GenePredict-PS): a study protocol for a double-blind, placebo-controlled, randomized two-period crossover study.","BACKGROUND
Functional food ingredients and natural health products have been demonstrated to reduce disease risk and thereby help to lower health care costs across populations at risk for chronic or degenerative diseases. However, typically a wide range of interindividual variability exists in response across individuals to nutritional and natural health product bioactives, such as plant sterols (PS). This study aims to determine and utilize information on the associations between genosets and the degree of responsiveness to dietary PS intervention, with a long-term objective of developing genetic tests to predict responses to PS.
METHODS
This clinical trial is designed as a double-blind, placebo controlled, randomized two-period crossover study. Sixty-four eligible participants with the specific a priori-determined single nucleotide polymorphisms (SNPs) associated with a responsiveness to PS will consume PS or a placebo treatment for two 4-week periods. The PS treatment consists of two daily single portions of margarine, each providing 1 g PS during the PS period (2.0 g/day of PS in total). The placebo will be an identical margarine containing no added PS. Low-density lipoprotein cholesterol (LDL-C) responsiveness to the controlled administration of PS will be investigated as the primary outcome, and the associations between interindividual genoset variabilities and response to PS consumption will be determined.
DISCUSSION
This research will provide further insight into whether the associations between previously identified SNPs and the response of LDL-C to PS consumption can be used in a predictive manner. It will also provide insight into the complexities of undertaking a nutrigenetic trial with prospective recruitment based on genotype.
TRIAL REGISTRATION
ClinicalTrials.gov: Identifier: NCT02765516. Registered on 6 May 2016.",2020,"BACKGROUND
Functional food ingredients and natural health products have been demonstrated to reduce disease risk and thereby help to lower health care costs across populations at risk for chronic or degenerative diseases.",['Sixty-four eligible participants with the specific a priori-determined single nucleotide polymorphisms (SNPs) associated with a responsiveness to PS will consume PS or a'],"['dietary PS intervention', 'PS', 'dietary plant sterol intervention (GenePredict-PS', 'placebo']",[],"[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],64.0,0.512484,"BACKGROUND
Functional food ingredients and natural health products have been demonstrated to reduce disease risk and thereby help to lower health care costs across populations at risk for chronic or degenerative diseases.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shamloo', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Granger', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Elke A', 'Initials': 'EA', 'LastName': 'Trautwein', 'Affiliation': 'Unilever R & D Vlaardingen, Vlaardingen, The Netherlands.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'House', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'MacKay', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB, Canada. dylan.mackay@umanitoba.ca.'}]",Trials,['10.1186/s13063-020-04364-5']
3468,32487180,Family Club Denmark #strongertogether - a volunteer intervention for disadvantaged families: study protocol for a quasi-experimental trial.,"BACKGROUND
Need-oriented family support programs are examples of voluntary-based interventions increasingly recognized by the public sector as an important contribution to health and social care provision. Voluntary interventions are attractive because of their focus on activism, inclusion, and participation, but also their low cost and easy accessibility. There is an increasing demand for documentation of the effectiveness of family support programs. Methodologically sound studies are, however, limited and findings are generally inconsistent. This trial aims to assess the effectiveness of the volunteer-based intervention Family Club Denmark on parental stress, mental health, development and well-being of parents and children and to get insight into the experiences of both volunteers and families.
METHODS
This is a prospective quasi-experimental trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group. Participants are families with children aged 2-12 years who wish to participate in the program. Participants are allocated to intervention primarily after a first-come-first-serve principle, and further families will join the wait-list and be offered participation after around 6 months. Quantitative data are collected through web surveys at three time-points: at baseline, post-intervention (6 months after baseline), and follow-up (12 months after baseline). The primary outcome is mental health. Secondary outcomes include parenting behavior, parenting stress, self-efficacy and self-worth, family routines and child well-being. Qualitative data are collected through observations, focus groups, and interviews.
DISCUSSION
This trial is among the first experimental studies of a group-based third sector need-oriented family support program offered to a wide array of families. The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines. Furthermore, the trial will provide knowledge on volunteer, parent, and child experiences with participating in the intervention and knowledge on how to conduct experimental trails in a complex volunteer environment.
TRIAL REGISTRATION
ClinicalTrials.govNCT03657888 (registered 29.08.2018).",2020,"The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines.","['Participants are families with children aged 2-12\u2009years who wish to participate in the program', 'Family Club Denmark #strongertogether - a volunteer intervention for disadvantaged families']","['intervention group participating in Family Club Denmark and (2) wait-list control group', 'volunteer-based intervention Family Club Denmark']","['mental health', 'parenting behavior, parenting stress, self-efficacy and self-worth, family routines and child well-being']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}]",,0.0487298,"The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines.","[{'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Pontoppidan', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark. mpo@vive.dk.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Thorsager', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark.'}, {'ForeName': 'Arendse Tange', 'Initials': 'AT', 'LastName': 'Larsen', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Friis-Hansen', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark.'}]",BMC psychology,['10.1186/s40359-020-00426-0']
3469,32487184,Fatigue following radiotherapy of low-risk early breast cancer - a randomized controlled trial of intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy: the COSMOPOLITAN trial (NCT03838419).,"BACKGROUND
Fatigue is one of the most common and distressing side-effects of breast cancer radiotherapy. According to current guidelines, accelerated partial breast irradiation (APBI) may be considered as an alternative treatment option for women with early-stage low-risk breast cancer. One method for APBI is single-dose intraoperative radiotherapy (IORT) applied directly to the tumor bed during breast conserving surgery (BCS). The COSMOPOLITAN trial therefore aims to analyze the intensity of fatigue following single-shot IORT with electrons (IOERT) compared to conventional hypofractionated whole breast irradiation (WBI) in low risk early breast cancer patients.
METHODS
This trial is conducted as a multicenter, prospective, randomized, two-arm phase II study comparing the intensity of fatigue in early-stage breast cancer (cT1cN0cM0, tumor size < 2,5 cm, ER pos. Her2neu neg., age > 50 years) treated either with WBI or APBI after BCS. Secondary outcomes investigated are tumor control, overall survival (OS), disease-free survival (DFS), acute and chronic toxicity, quality of life (QoL) and cosmesis. A total of 202 patients will be randomized into two arms: Patients in arm A will receive WBI (40.05 Gy, 15 fractions) after surgical resection, while patients in arm B will receive IOERT (21 Gy to the 90%-isodose) during BCS. Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
DISCUSSION
The present trial aims to evaluate treatment response to compare single-shot intraoperative electron APBI to conventional WBI following BCS in early-stage low risk breast cancer patients. Fatigue is selected as the primary, patient-reported endpoint due its major clinical relevance.
TRIAL REGISTRATION
The study is prospectively registered on February 12th, 2019: Clinicaltrials.gov, NCT03838419. ""Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer (COSMOPOLITAN)"".
STUDY STATUS
Ongoing study. Start of recruitment was December 2019.",2020,"Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
","['low risk early breast cancer patients', 'women with early-stage low-risk breast cancer', 'low-risk early breast cancer', 'early-stage low risk breast cancer patients', '202 patients']","['radiotherapy', 'conventional hypofractionated whole breast irradiation (WBI', 'Intraoperative Electron Radiotherapy', 'intraoperative radiotherapy (IORT', 'WBI or APBI', 'intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy', 'single-shot intraoperative electron APBI to conventional WBI following BCS', 'IOERT', 'single-shot IORT with electrons (IOERT', 'accelerated partial breast irradiation (APBI']","['Chronic Illness Therapy (FACIT) Fatigue Scale', 'tumor control, overall survival (OS), disease-free survival (DFS), acute and chronic toxicity, quality of life (QoL) and cosmesis', 'Fatigue']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C3896696', 'cui_str': 'Accelerated partial breast irradiation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",202.0,0.13722,"Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Forster', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Jäkel', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sati', 'Initials': 'S', 'LastName': 'Akbaba', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krempien', 'Affiliation': 'Department of Radiation Oncology, Helios Hospital Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Uhl', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Matthias Felix', 'Initials': 'MF', 'LastName': 'Häfner', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'König', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Stefan Alexander', 'Initials': 'SA', 'LastName': 'Koerber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Semi', 'Initials': 'S', 'LastName': 'Harrabi', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernhardt', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Rouven', 'Initials': 'R', 'LastName': 'Behnisch', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Hennigs', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Sohn', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hörner-Rieber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. juliane.hoerner-rieber@med.uni-heidelberg.de.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01581-9']
3470,32487210,"Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study).","BACKGROUND
Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality.
METHODS/DESIGN
The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled.
DISCUSSION
The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.",2020,"In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery.","['patients with PUGIF', 'upper gastrointestinal fistula after surgery', '321 patients will be enrolled']","['total parenteral nutrition (TPN', 'Enteral versus parenteral nutrition', 'TPN', 'EN versus TPN', 'PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation', 'enteral nutrition (EN']","['30-day and 6-month postrandomization mortality rate, nutritional status', '30-day fistula closure rate', 'fistula-related complication rate', '6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate', ""mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment"", 'length of hospital stay, reduced health-related quality of life and increased health costs', 'late fistula-related complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]","[{'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0450198', 'cui_str': 'Duodenojejunal'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0441508', 'cui_str': 'Fistula repair'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1948041', 'cui_str': 'Surgical and medical procedures'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",321.0,0.0556466,"In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gronnier', 'Affiliation': 'Department of Visceral Surgery, Centre Médico-chirurgical Magellan, Pessac, France. caroline.gronnier@chu-bordeaux.fr.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Chambrier', 'Affiliation': 'Department of Nutrition and Intestinal Rehabilitation, Lyon Sud University Hospital, Pierre-Bénite, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Pôle de Santé Publique, Department of Biostatistic, University Hospital of Lille, Lille, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Dervaux', 'Affiliation': 'Maison Régionale de la Recherche Clinique, Hospitalière et Universitaire - CHRU de Lille, Lille, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Collet', 'Affiliation': 'Department of Visceral Surgery, Centre Médico-chirurgical Magellan, Pessac, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Vaudoyer', 'Affiliation': 'Department of Visceral Surgery, Lyon Sud University Hospital, Pierre-Bénite, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Régimbeau', 'Affiliation': 'Department of Visceral Surgery, Amiens University Hospital, Amiens, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Jougon', 'Affiliation': 'Department of Thoracic Surgery, Centre Médico-chirurgical Magellan, Bordeaux University Hospital, Pessac, France.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Théréaux', 'Affiliation': 'Department of Visceral Surgery, Hospital Center Regional University, Brest, France.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Lebreton', 'Affiliation': 'Department of Visceral Surgery, Caen University Hospital, Caen, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Veziant', 'Affiliation': 'Department of Visceral Surgery, Gabriel-Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Valverde', 'Affiliation': 'Department of Visceral Surgery, Diaconesses Hospital, Paris, France.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ortega-Deballon', 'Affiliation': 'Department of Visceral Surgery, University Hospital Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Pattou', 'Affiliation': 'Department of Visceral and Endocrine Surgery, Huriez University Hospital, Lille, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Mathonnet', 'Affiliation': 'Department of Visceral Surgery, Dupuytren University Hospital, Limoges, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Perinel', 'Affiliation': 'Department of Visceral Surgery, Edouard Herriot University Hospital, Lyon, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beyer-Berjot', 'Affiliation': 'Department of Visceral Surgery, Hôpital Nord, Marseille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fuks', 'Affiliation': 'Department of Visceral Surgery, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rouanet', 'Affiliation': 'Department of Visceral Surgery, Institut Regional Cancer Montpellier, Montpellier, France.'}, {'ForeName': 'Jérémie H', 'Initials': 'JH', 'LastName': 'Lefevre', 'Affiliation': 'Department of Visceral Surgery, Saint-Antoine University Hospital, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Cattan', 'Affiliation': 'Department of Visceral Surgery, Saint-Louis University Hospital, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Deguelte', 'Affiliation': 'Department of Visceral Surgery, Robert Debré University Hospital, Reims, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Department of Visceral Surgery, Pontchaillou University Hospital, Rennes, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Department of Visceral Surgery, Rouen, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Pessaux', 'Affiliation': 'Department of Visceral Surgery, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Carrere', 'Affiliation': 'Department of Visceral Surgery, Purpan University Hospital, Toulouse, France.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Salame', 'Affiliation': 'Department of Visceral Surgery, Tours, France.'}, {'ForeName': 'Eleonor', 'Initials': 'E', 'LastName': 'Benaim', 'Affiliation': 'Department of Visceral Surgery, Gustave Roussy Institute, Villejuif, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Dousset', 'Affiliation': 'Department of Visceral Surgery, Cochin Hospital, Paris, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': 'Department of Visceral Surgery, Bichat Hospital, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'Department of Digestive and Oncological Surgery, Lille University Hospital, Lille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Department of Digestive and Oncological Surgery, Lille University Hospital, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04366-3']
3471,32487213,"The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis: a prospective, randomized, double-blinded, placebo-controlled phase III study (ABAP study).","BACKGROUND
Approximately 30% of appendectomies are for complicated acute appendicitis (CAA). With laparoscopy, the main post-operative complication is deep abscesses (12% of cases of CAA, versus 4% for open surgery). A recent cohort study compared short and long courses of postoperative antibiotic therapy in patients with CAA. There was no significant intergroup difference in the post-operative complication rate (12% of organ/space surgical site infection (SSI)). Moreover, antibiotic therapy is increasingly less indicated for other situations (non-complicated appendicitis, post-operative course of cholecystitis, perianal abscess), calling into question whether post-operative antibiotic therapy is required after laparoscopic appendectomy for CAA.
METHODS/DESIGN
This study is a prospective, multicenter, parallel-group, randomized (1:1), double-blinded, placebo-controlled, phase III non-inferiority study with blind evaluation of the primary efficacy criterion. The primary objective is to evaluate the impact of the absence of post-operative antibiotic therapy on the organ/space surgical site infection (SSI) rate in patients presenting with CAA (other than in cases of generalized peritonitis). Patients in the experimental group will receive at least one dose of preoperative and perioperative antibiotic therapy (2 g ceftriaxone by intravenous injection every 24 h up to the operation) and metronidazole (500 mg by intravenous injection every 8 h up to the operation) and, in the post-operative period, a placebo for ceftriaxone (2 g/24 h in one intravenous injection) and a placebo for metronidazole (1500 mg/24 h in three intravenous injections, for 3 days). In the control group, patients will receive at least one dose of preoperative and perioperative antibiotic therapy (2 g ceftriaxone by intravenous injection every 24 h up to the operation) and metronidazole (500 mg by intravenous injection every 8 h up to the operation) and, in the post-operative period, antibiotic therapy (ceftriaxone 2 g/24 h and metronidazole 1500 mg/24 h for 3 days). In the event of allergy to ceftriaxone, it will be replaced by levofloxacin (500 mg/24 h in one intravenous injection, for 3 days). The expected organ space SSI rate is 12% in the population of patients with CAA operated on by laparoscopy. With a non-inferiority margin of 5%, a two-sided alpha risk of 5%, a beta risk of 20%, and a loss-to-follow-up rate of 10%, the calculated sample size is 1476 included patients, i.e., 738 per group. Due to three interim analyses at 10%, 25%, and 50% of the planned sample size, the total sample size increases to 1494 patients (747 per arm).
TRIAL REGISTRATION
Ethical authorization by the Comité de Protection des Personnes and the Agence Nationale de Sécurité du Médicament: ID-RCB 2017-00334-59. Registered on ClinicalTrials.gov (NCT03688295) on 28 September 2018.",2020,There was no significant intergroup difference in the post-operative complication rate (12% of organ/space surgical site infection (SSI)).,"['patients presenting with CAA (other than in cases of generalized peritonitis', 'patients with CAA', 'complicated acute appendicitis']","['placebo for metronidazole', 'post-operative antibiotic therapy', 'RCB', 'metronidazole', 'laparoscopic appendectomy', 'postoperative antibiotic therapy', 'antibiotic therapy (ceftriaxone 2\u2009g/24\u2009h and metronidazole', 'levofloxacin', 'placebo for ceftriaxone', 'perioperative antibiotic therapy (2\u2009g ceftriaxone', 'preoperative and perioperative antibiotic therapy (2\u2009g ceftriaxone', 'ceftriaxone', 'antibiotic therapy', 'placebo']","['organ/space surgical site infection (SSI) rate', 'post-operative complication rate', 'organ space SSI rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C3662314', 'cui_str': 'Organ-space surgical site infection'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.149827,There was no significant intergroup difference in the post-operative complication rate (12% of organ/space surgical site infection (SSI)).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sabbagh', 'Affiliation': 'Department of Digestive Surgery, Amiens University Hospital, Amiens University Medical Center, Avenue Laennec, F-80054, Amiens cedex 01, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Siembida', 'Affiliation': 'Department of Digestive Surgery, Amiens University Hospital, Amiens University Medical Center, Avenue Laennec, F-80054, Amiens cedex 01, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dupont', 'Affiliation': 'Jules Verne University of Picardie, Amiens, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diouf', 'Affiliation': 'Department of Methodology, Biostatistics, Direction of Clinical Research, Amiens University Medical Center, Amiens, France.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Schmit', 'Affiliation': 'Jules Verne University of Picardie, Amiens, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boddaert', 'Affiliation': 'Department of Pharmacology, Amiens University Medical Center, Amiens, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Regimbeau', 'Affiliation': 'Department of Digestive Surgery, Amiens University Hospital, Amiens University Medical Center, Avenue Laennec, F-80054, Amiens cedex 01, France. regimbeau.jean-marc@chu-amiens.fr.'}]",Trials,['10.1186/s13063-020-04411-1']
3472,32487507,Reducing the Number of Opioids Consumed After Discharge Following Elective Cesarean Delivery: A Randomized Controlled Trial.,"OBJECTIVE
To reduce opioids consumed after discharge from hospital after elective cesarean delivery by 50%.
METHODS
This was a two-week parallel group non-blinded randomized controlled trial at Mount Sinai Hospital. Eligible women undergoing elective cesarean delivery were assigned by random number generation to receive the hospital's standard post-cesarean opioid prescription of 20 1-mg hydromorphone tablets or a prescription for 10 1-mg hydromorphone tablets if opioids were required in hospital or no hydromorphone if no opioids were required in hospital. Patients completed a study questionnaire at two weeks postpartum detailing outcome measures. The primary outcome was the amount of opioid consumed after discharge.
RESULTS
A total of 40 women were randomly assigned to a study group and 37 were included in the data analysis; 17 patients were in the control group and 20 in the experimental group. The median number of tablets consumed did not differ between groups (P = 0.407). The median number of excess tablets prescribed was 20 (range 2-18) in the control group and 0 (range 0-10) in the experimental group (P < 0.001).
CONCLUSIONS
The current standard discharge practice of giving 20 1-mg hydromorphone tablets to all patients post-discharge after cesarean delivery contributes to a substantial excess of opioids in the community. These opioids can be diverted for unintended or accidental usage, and exacerbate larger societal issues of opioid misuse and addiction. Decreasing the number of opioids prescribed with tailored discharge prescriptions based on in-hospital opioid use provides nearly all patients with adequate pain control.",2020,The median number of tablets consumed did not differ between groups (P = 0.407).,"['Eligible women undergoing elective cesarean delivery', 'A total of 40 women were randomly assigned to a study group and 37 were included in the data analysis; 17 patients were in the control group and 20 in the experimental group']","['hydromorphone tablets if opioids were required in hospital or no hydromorphone if no opioids', 'hydromorphone tablets']","['median number of excess tablets', 'median number of tablets', 'amount of opioid consumed after discharge', 'Number of Opioids Consumed']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",40.0,0.373934,The median number of tablets consumed did not differ between groups (P = 0.407).,"[{'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Gold', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Figueiro-Filho', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Mount Sinai Hospital, Department of Obstetrics and Gynecology, Toronto, ON.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Mount Sinai Hospital, Department of Obstetrics and Gynecology, Toronto, ON.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Selk', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Mount Sinai Hospital, Department of Obstetrics and Gynecology, Toronto, ON. Electronic address: amanda.selk@utoronto.ca.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2020.02.123']
3473,32487542,"Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study.","BACKGROUND
In RECOURSE (, trifluridine/tipiracil significantly improved overall survival and progression-free survival (PFS) versus placebo in patients with pretreated metastatic colorectal cancer (mCRC). PRECONNECT was designed to further characterise safety and clinical use of trifluridine/tipiracil.
METHODS
In this ongoing, international, multicentre, open-label trial, patients with pretreated mCRC received oral trifluridine/tipiracil 35 mg/m 2 twice daily on days 1-5 and 8-12 of each 28-day cycle. The primary endpoint was safety; secondary endpoints included PFS and quality of life (QoL).
RESULTS
793 patients (median age 62 years) from 13 countries received trifluridine/tipiracil for a median of 2.84 months (IQR 2.64). Adverse events (AEs) were experienced by 96.7%; the most common (≥20% of patients) were neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea. Grade ≥3 AEs occurred in 73.9% of patients, with the most common being neutropaenia (39.1% of patients), anaemia (9.8%) and asthenia/fatigue (5.0%). Median PFS was 2.8 months (95% CI 2.7 to 2.9). Median time to Eastern Cooperative Oncology Group performance status deterioration (≥2) was 8.9 months (range 0.03-14.72). There was no clinically relevant change from baseline in QoL.
CONCLUSIONS
PRECONNECT showed consistent results with the previously demonstrated safety and efficacy profile of trifluridine/tipiracil, with no new safety concerns identified. QoL was maintained during treatment.
TRIAL REGISTRATION NUMBER
NCT03306394.",2020,"Adverse events (AEs) were experienced by 96.7%; the most common (≥20% of patients) were neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea.","['pretreated metastatic colorectal cancer', 'patients with pretreated metastatic colorectal cancer (mCRC', '793 patients (median age 62 years) from 13 countries received']","['trifluridine/tipiracil', 'oral trifluridine/tipiracil', 'placebo']","['overall survival and progression-free survival (PFS', 'Median PFS', 'asthenia/fatigue', 'QoL', 'Grade ≥3 AEs', 'anaemia', 'Adverse events (AEs', 'PFS and quality of life (QoL', 'neutropaenia', 'Safety, efficacy', 'neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",793.0,0.306629,"Adverse events (AEs) were experienced by 96.7%; the most common (≥20% of patients) were neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea.","[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Department of Hepatogastroenterology, University Hospital Pitié Salpêtrière, Paris, Île-de-France, France jean-baptiste.bachet@aphp.fr.'}, {'ForeName': 'Lucjan', 'Initials': 'L', 'LastName': 'Wyrwicz', 'Affiliation': 'Department of Oncology and Radiotherapy, Maria Skłodowska Curie Memorial Cancer Centre and Institute of Oncology Warsaw, Warszawa, Poland.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Price', 'Affiliation': 'Department of Medical Oncology, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Toscana, Italy.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Phelip', 'Affiliation': 'Department of Gastroenterology, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, Rhône-Alpes, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': 'Department of Medical Oncology, Institut régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Ozet', 'Affiliation': 'Department of Medical Oncology, Gazi University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Department of Medical Oncology, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Atlan', 'Affiliation': 'Global Medical Affairs, Servier Médical, Suresnes, Île-de-France, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Becquart', 'Affiliation': 'Global Medical Affairs, Servier Médical, Suresnes, Île-de-France, France.'}, {'ForeName': 'Loick', 'Initials': 'L', 'LastName': 'Vidot', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Nadjat', 'Initials': 'N', 'LastName': 'Mounedji', 'Affiliation': 'Global Medical Affairs, Servier Médical, Suresnes, Île-de-France, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Digestive Oncology, KU Leuven University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Gastroenterology and Digestive Oncology, European Hospital Group Georges-Pompidou, Paris, Île-de-France, France.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Toscana, Italy.'}]",ESMO open,['10.1136/esmoopen-2020-000698']
3474,32487567,"Osimertinib Called ""Home Run"" for EGFR-Mutant NSCLC.","Adjuvant treatment with the tyrosine kinase inhibitor osimertinib will likely become a new standard of care in patients with EGFR -mutant non-small cell lung cancer. In the phase III ADAURA trial, 90% of patients with stage II-IIIA disease who received osimertinib were alive and free of cancer at 2 years, compared with 44% who received a placebo-results considered so striking that researchers unblinded the trial early.",2020,Adjuvant treatment with the tyrosine kinase inhibitor osimertinib will likely become a new standard of care in patients with EGFR -mutant non-small cell lung cancer.,"['patients with stage II-IIIA disease who received osimertinib were alive and free of cancer at 2 years', 'patients with EGFR -mutant non-small cell lung cancer']",['placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],90.0,0.0800407,Adjuvant treatment with the tyrosine kinase inhibitor osimertinib will likely become a new standard of care in patients with EGFR -mutant non-small cell lung cancer.,[],Cancer discovery,['10.1158/2159-8290.CD-NB2020-053']
3475,32487568,Trastuzumab Deruxtecan Impresses in Solid Cancers.,"Trastuzumab deruxtecan may be effective in solid cancers in addition to breast cancer. In a randomized phase II trial of HER2-positive gastric and gastroesophageal junction cancers, the agent significantly extended overall survival and progression-free survival compared with standard chemotherapy. It also elicited high response rates in phase II trials of HER2-mutant non-small cell lung cancer and HER2-positive colorectal cancer.",2020,"In a randomized phase II trial of HER2-positive gastric and gastroesophageal junction cancers, the agent significantly extended overall survival and progression-free survival compared with standard chemotherapy.",['Solid Cancers'],"['Trastuzumab deruxtecan', 'standard chemotherapy']",['overall survival and progression-free survival'],"[{'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0396085,"In a randomized phase II trial of HER2-positive gastric and gastroesophageal junction cancers, the agent significantly extended overall survival and progression-free survival compared with standard chemotherapy.",[],Cancer discovery,['10.1158/2159-8290.CD-ND2020-011']
3476,32487594,Health literacy and exercise interventions on clinical outcomes in Chinese patients with diabetes: a propensity score-matched comparison.,"INTRODUCTION
Patients with diabetes in China have low health literacy, which likely leads to poor clinical outcomes. This study aimed to assess the effectiveness of health literacy and exercise interventions on clinical measurements in Chinese adults with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS
A cluster randomized controlled trial was conducted from February 2015 through April 2017 in Shanghai, China. 799 patients with T2DM aged 18 years or older recruited from eight Community Healthcare Centers were randomized into one control arm and three intervention arms receiving 1-year health literacy intervention, exercise intervention or both as the comprehensive intervention. Propensity score matching was employed to minimize potential imbalance in randomization. The intervention-attributable effects on main clinical outcomes were estimated using a difference-in-difference regression approach.
RESULTS
After propensity score matching, 634 patients were included in the analysis. The three intervention groups had decreased hemoglobin A1c (A1c) level after 12 months of intervention. The largest adjusted decrease was observed in the health literacy group (-0.95%, 95% CI: -1.30 to -0.59), followed by the exercise group (-0.81%, 95% CI: -1.17 to -0.45). However, A1c was observed to increase in the health literacy and the comprehensive groups from 12 to 24 months. No obvious changes were observed for other measurements including high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures.
CONCLUSIONS
Health literacy and exercise-focused interventions improve glycemic control in Chinese patients with diabetes after 12 months of intervention, and the health literacy intervention shows the greatest effect. Our results suggest that the interventions may have the potential to improve diabetes self-management and reduce diabetes burden in China.
TRIAL REGISTRATION NUMBER
ISRCTN76130594.",2020,"No obvious changes were observed for other measurements including high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures.
","['Chinese patients with diabetes', 'Patients with diabetes in China have low health literacy', '634 patients were included in the analysis', 'Chinese adults with type 2 diabetes mellitus (T2DM', '799 patients with T2DM aged 18 years or older recruited from eight Community Healthcare Centers', 'February 2015 through April 2017 in Shanghai, China']","['Health literacy and exercise interventions', 'health literacy and exercise interventions', '1-year health literacy intervention, exercise intervention or both as the comprehensive intervention', 'Health literacy and exercise-focused interventions']","['high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures', 'hemoglobin A1c (A1c) level', 'health literacy']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",799.0,0.066618,"No obvious changes were observed for other measurements including high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Lab of Health Technology Assessment (National Health Commission), School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Yingyao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Key Lab of Health Technology Assessment (National Health Commission), School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Yingnan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Division of Clinical and Administrative Science, College of Pharmacy, Xavier University of Louisiana, Louisiana, New Orleans, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rothman', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ming', 'Affiliation': 'Key Lab of Health Technology Assessment (National Health Commission), School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety (National Ministry of Education), Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety (National Ministry of Education), Fudan University, Shanghai, China.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Global Health Management and Policy, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Wanghong', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety (National Ministry of Education), Fudan University, Shanghai, China wanghong.xu@fudan.edu.cn.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001179']
3477,32488263,Efficacy and Safety of Two Fixed-Dose Combinations of Tramadol Hydrochloride and Diclofenac Sodium in Postoperative Dental Pain.,"OBJECTIVE
To evaluate the analgesic efficacy and safety of tramadol hydrochloride/diclofenac sodium fixed-dose combination 25 mg/25 mg (FDC 25/25) and 50 mg/50 mg (FDC 50/50) vs tramadol 50 mg (T50) and diclofenac 50 mg (D50) monotherapies in acute postoperative dental pain.
SETTING
Eight sites across Mexico.
SUBJECTS
Adults (N = 829) with moderate to severe pain after third molar extraction.
DESIGN
Prospective, randomized, double-blind, diclofenac- and tramadol-controlled, parallel-group, noninferiority, phase 3 trial.
METHODS
Subjects were randomized to receive three doses (one every eight hours) of oral FDC 25/25, FDC 50/50, T50, or D50 over a 24-hour period. Pain intensity and pain relief were evaluated frequently over the 24 hours postdose. Secondary measures included peak pain relief, onset, and duration of effect. The primary objective was to compare the analgesic efficacy and safety of FDC 50/50 or analgesic noninferiority of FDC 25/25 vs D50 or T50. The primary efficacy end point was total pain relief over four hours after dose 1 (TOTPAR4).
RESULTS
TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components. All secondary efficacy measures supported these results. The safety profile of FDC 25/25 and FDC 50/50 was consistent with the known safety profile of D50 and T50 monotherapies, with no unexpected safety findings observed.
CONCLUSIONS
Tramadol/diclofenac FDC 25/25 and FDC 50/50 provide superior analgesia for acute pain after third molar extraction than either of the individual components. Minor adverse effects appeared to be related to the higher doses of tramadol.",2020,"RESULTS
TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components.","['acute postoperative dental pain', 'Adults (N\u2009=\u2009829) with moderate to severe pain after third molar extraction', 'Subjects', 'Eight sites across Mexico']","['tramadol 50\u2009mg (T50) and diclofenac 50\u2009mg (D50) monotherapies', 'oral FDC 25/25, FDC 50/50, T50, or D50 over a 24-hour period', 'diclofenac- and tramadol', 'tramadol hydrochloride/diclofenac sodium fixed-dose combination 25\u2009mg/25\u2009mg (FDC 25/25) and 50\u2009mg/50\u2009mg (FDC 50/50', 'FDC', 'tramadol', 'Tramadol/diclofenac FDC', 'Tramadol Hydrochloride and Diclofenac Sodium']","['Postoperative Dental Pain', 'Efficacy and Safety', 'Pain intensity and pain relief', 'analgesic efficacy and safety', 'peak pain relief, onset, and duration of effect', 'TOTPAR4 scores', 'total pain relief']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C2350089', 'cui_str': 'Tramadol hydrochloride'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",829.0,0.338081,"RESULTS
TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Desjardins', 'Affiliation': 'Desjardins Associates, LLC, Maplewood, New Jersey.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Alvarado', 'Affiliation': 'ECI-Estudios Clínicos Internacionales, Puebla, México.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Gil', 'Affiliation': 'Eukarya Pharmasite S.C., Monterrey, México.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Instituto de Investigación del Hospital Cardiológica, Aguascalientes, México.'}, {'ForeName': 'Rogelio', 'Initials': 'R', 'LastName': 'Guajardo', 'Affiliation': 'Centro de Investigación Farmacológica del Bajío, S.C., León, Guanajuato, México.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa124']
3478,32488332,Effect of a rabeprazole half-dose twice daily on acid inhibition in patients with different CYP2C19 alleles.,"PURPOSE
Fractional doses of proton pump inhibitors (PPIs) more often than once daily (qd) inhibit 24-h acid secretion more effectively than an increase in the standard single daily dose. Although rabeprazole 5 mg qd is covered for prevention of aspirin-induced gastric injury under the Japanese insurance system, it is unclear whether rabeprazole 5 mg twice daily (bid) would more effectively inhibit acid secretion. We compared acid inhibition between rabeprazole 10 mg qd and 5 mg bid in healthy volunteers with different alleles of CYP2C19.
METHODS
Twelve Helicobacter pylori-negative healthy volunteers (CYP2C19 genotypes: extensive metabolizer (EM) (n = 6) and poor metabolizer (PM) (n = 6)) received three kinds of regimen for 7 days under a randomized crossover design: rabeprazole 5 mg qd (5 mg QD), 10 mg qd (10 mg QD), and 5 mg bid (5 mg BID). A 24-hour pH monitoring was conducted before the trial and on day 7 of each regimen.
RESULTS
No significant differences in median pH values (4.0 (1.9-5.9)) and (4.4 (2.1-6.5)) or percent time of pH ≥ 4 (50.7% (11.9-86.8%) and 56.8% (19.3-83.9%)) were seen between the 10 mg QD and 5 mg BID regimens. Median pHs and percent time of pH ≥ 4 in CYP2C19 PMs were significantly higher than those in EMs. With 5 mg BID, there was no significant difference in percent-time with pH ≥ 4 between daytime and nighttime, but the 10 mg QD showed a significant difference.
CONCLUSION
Rabeprazole 5 mg bid provided no therapeutic advantage for acid inhibition compared with rabeprazole 10 mg qd, regardless of CYP2C19 genotype status.",2020,"CONCLUSION
Rabeprazole 5 mg bid provided no therapeutic advantage for acid inhibition compared with rabeprazole 10 mg qd, regardless of CYP2C19 genotype status.","['healthy volunteers with different alleles of CYP2C19', 'patients with different CYP2C19 alleles', 'Twelve Helicobacter pylori-negative healthy volunteers (CYP2C19 genotypes: extensive metabolizer (EM) (n = 6) and poor metabolizer (PM) (n = 6']","['proton pump inhibitors (PPIs', 'rabeprazole', 'Rabeprazole']","['percent-time with pH ≥ 4 between daytime and nighttime', 'median pH values', 'Median pHs and percent time of pH ≥ 4 in CYP2C19 PMs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}]",12.0,0.0294771,"CONCLUSION
Rabeprazole 5 mg bid provided no therapeutic advantage for acid inhibition compared with rabeprazole 10 mg qd, regardless of CYP2C19 genotype status.","[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization, Kyoto Medical Center, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Mitsushige', 'Initials': 'M', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Gastroenterological Endoscopy, Tokyo Medical University Hospital, 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. sugimo@tokyo-med.ac.jp.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02917-w']
3479,32488361,"Split-leg modified lateral versus prone position in percutaneous nephrolithotomy: a prospective, randomized trial.","PURPOSE
Standard prone position (PP) during percutaneous nephrolithotomy (PNL) has multiple drawbacks. We aimed to compare PNLs performed in split-leg (SL) modified lateral position (MLP) and those performed in standard PP.
METHODS
A prospective, randomized, unblind, double arm trial was conducted at a tertiary care academic medical center in Egypt, between November 2017 and October 2019. Adult patients with renal stones undergoing PNL were included. According to renal anatomy and stone complexity, stratified randomization was performed and study participants were allocated into either SL-MLP group or PP group. The stone free rate (SFR), total operative time, track formation time, fluoroscopy time, auxiliary procedures, and complications were compared.
RESULTS
There were 61 patients in SL-MLP group and 63 patients in PP group. Both groups had similar baseline characteristics. The SFR was comparable between groups: 75.4% in SL-MLP group and 77.8% in PP group (p = 0.755). The mean total operative time was shorter and mean track formation time was longer in SL-MLP group (55.33 ± 20.73 vs. 98.49 ± 9.23, p < 0.001 and 7.89 ± 3.68 vs. 6.52 ± 1.77, p = 0.002). There was no significant difference in fluoroscopy time, total complication rates, hemoglobin reduction and need for blood transfusion between the groups. In SL-MLP group, all PNL procedures as well all the associated procedures were performed with the patients in the same position.
CONCLUSION
SL-MLP PNL has a short operative time and similar SFR and complication rate compared to PP PNL. SL-MLP allowed antegrade and retrograde access to the urinary tract without patient repositioning.",2020,"There was no significant difference in fluoroscopy time, total complication rates, hemoglobin reduction and need for blood transfusion between the groups.","['61 patients in SL-MLP group and 63 patients in PP group', 'tertiary care academic medical center in Egypt, between November 2017 and October 2019', 'Adult patients with renal stones undergoing PNL were included']","['percutaneous nephrolithotomy (PNL', 'percutaneous nephrolithotomy', 'SL-MLP', 'split-leg (SL) modified lateral position (MLP', 'Split-leg modified lateral versus prone position']","['mean track formation time', 'operative time and similar SFR and complication rate', 'fluoroscopy time, total complication rates, hemoglobin reduction and need for blood transfusion', 'mean total operative time', 'stone free rate (SFR), total operative time, track formation time, fluoroscopy time, auxiliary procedures, and complications', 'SFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0387511,"There was no significant difference in fluoroscopy time, total complication rates, hemoglobin reduction and need for blood transfusion between the groups.","[{'ForeName': 'Abul-Fotouh', 'Initials': 'AF', 'LastName': 'Ahmed', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt. abulfotouhahmed@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Gomaa', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Daoud', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Solyman', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Abdelazim', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'El-Feky', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Agha', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Fahim', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}]",World journal of urology,['10.1007/s00345-020-03285-x']
3480,32488368,Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up. A randomized controlled trial.,"PURPOSE
To evaluate if adding nanofractures to the footprint of a supraspinatus tear repair would have any effect in the outcomes at one-year follow-up.
METHODS
Multicentric, triple-blinded, randomized trial with 12-months follow-up. Subjects with isolated symptomatic reparable supraspinatus tears smaller than 3 cm and without grade 4 fatty infiltration were included. These were randomized to two groups: In the Control group an arthroscopic supraspinatus repair was performed; in the Nanofracture group the footprint was additionally prepared with nanofractures (1 mm wide, 9 mm deep microfractures). Clinical evaluation was done with Constant score, EQ-5D-3L, and Brief Pain Inventory. The primary outcome was the retear rate in MRI at 12-months follow-up. Secondary outcomes were: characteristics of the retear (at the footprint or at the musculotendinous junction) and clinical outcomes.
RESULTS
Seventy-one subjects were randomized. Two were lost to follow-up, leaving 69 participants available for assessment at 12-months follow-up (33 in the Control group and 36 in the Nanofracture Group). The Nanofracture group had lower retear rates than the Control group (7/36 [19.4%] vs 14/33 [42.4%], differences significant, p = 0.038). Retear rates at the musculotendinous junction were similar but the Nanofracture group had better tendon healing rates to the bone (34/36 [94.4%] vs. 24/33 [66.71%], p = 0.014). Clinically both groups had significant improvements, but no differences were found between groups.
CONCLUSION
Adding nanofractures at the footprint during an isolated supraspinatus repair lowers in half the retear rate at 12-months follow-up. This is due to improved healing at the footprint.
LEVEL OF EVIDENCE
Level I.",2020,"Retear rates at the musculotendinous junction were similar but the Nanofracture group had better tendon healing rates to the bone (34/36 [94.4%] vs. 24/33 [66.71%], p = 0.014).","['Subjects with isolated symptomatic reparable supraspinatus tears smaller than 3\xa0cm and without grade 4 fatty infiltration were included', 'Seventy-one subjects were randomized']",['arthroscopic supraspinatus repair'],"['tendon healing rates', 'characteristics of the retear (at the footprint or at the musculotendinous junction) and clinical outcomes', 'retear rates', 'retear rate in MRI', 'Constant score, EQ-5D-3L, and Brief Pain Inventory']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0439059', 'cui_str': 'Supraspinatus tear'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0333575', 'cui_str': 'Fatty infiltration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450389', 'cui_str': '71'}]","[{'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0584646', 'cui_str': 'Musculotendinous junction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",71.0,0.122116,"Retear rates at the musculotendinous junction were similar but the Nanofracture group had better tendon healing rates to the bone (34/36 [94.4%] vs. 24/33 [66.71%], p = 0.014).","[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Ruiz Ibán', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain. drmri@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sanchez Alepuz', 'Affiliation': 'Hospital IMED Valencia, Valencia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Diaz Heredia', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Abdul-Ilah', 'Initials': 'AI', 'LastName': 'Hachem', 'Affiliation': 'Head of the Shoulder Unit, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Ezagüi Bentolila', 'Affiliation': 'Hospital Egarsat, Barcelona, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Calvo', 'Affiliation': 'Arthrosport, Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Verdú', 'Affiliation': 'Unidad de Hombro y Codo, Hospital General Universitario de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'de Rus Aznar', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Soler Romagosa', 'Affiliation': 'Traumadvance, Terrassa, Barcelona, Spain.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06073-7']
3481,32490004,"Effect of education based on ""PRECEDE"" model on self-care behavior in hemodialysis patients.","BACKGROUND AND OBJECTIVE
Patients undergoing hemodialysis due to multiple drug therapies, special diet plans, and need to acquire the ability to adapt to physical and mental disabilities require special monitoring. The PRECEDE-PROCEED model is a process for behavior change and can lead to the promotion of self-care behavior. The aim of this study was to evaluate the effect of a health promotion program based on the PRECEDE-PROCEED model on self-care behaviors in hemodialysis patients.
METHODS
This was a clinical trial study that was performed on 67 patients undergoing hemodialysis in Lordegan Hospital that has been distributed in two groups randomly. Data were collected using self-care assessment form according to the PRECEDE-PROCEED model. Based on the results of this questionnaire, five educational sessions were held in the fields of knowledge, attitude, enabling factors, reinforcement, and behavioral factors for the samples. Data were analyzed using descriptive and analytical statistics with SPSS version 21 software.
RESULTS
According to statistical analysis before intervention, no significant difference was observed between the mean scores of self-care among the two groups. However, instantly and 3 months after intervention, the mean score of self-care ( P = 0/03), knowledge, attitude, reinforcement factors, and behavioral factors ( P < 0.05) significantly increased in the experimental group.
CONCLUSION
Based on the results of this study PRECEDE-PROCESS model, the health promotion program increased the mean self-care score of hemodialysis patients. This program has been able to improve their self-care behaviors by changing knowledge, attitudes, and reinforcement and behavioral factors of patients and is recommending as an application in the nursing of these patients.",2020,"However, instantly and 3 months after intervention, the mean score of self-care ( P = 0/03), knowledge, attitude, reinforcement factors, and behavioral factors ( P < 0.05) significantly increased in the experimental group.
","['Patients undergoing hemodialysis', 'hemodialysis patients', '67 patients undergoing hemodialysis in Lordegan Hospital that has been distributed in two groups randomly']",['health promotion program'],"['knowledge, attitude, reinforcement factors, and behavioral factors', 'mean scores of self-care', 'mean score of self-care', 'mean self-care score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]",67.0,0.0122358,"However, instantly and 3 months after intervention, the mean score of self-care ( P = 0/03), knowledge, attitude, reinforcement factors, and behavioral factors ( P < 0.05) significantly increased in the experimental group.
","[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Mosavi', 'Affiliation': 'Community Oriented Research Center in Midwifery and Nursing Sciences, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Aliakbari', 'Affiliation': 'Community Oriented Research Center in Midwifery and Nursing Sciences, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Rabiei', 'Affiliation': 'Health School, Shahrekord University of Medical Science, Shahrekord, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_534_19']
3482,32490009,Schoolchild as a health educator for parents regarding hypertension: A quasi-experimental study among school students of South India.,"BACKGROUND
An alarming trend of sustained blood pressure elevation among children and adolescents has been found. Health education to schoolchildren in their formative age is the most effective method to be able to modify their habits, and further, they can be enrolled as an effective health educator for their parents.
OBJECTIVE
To study the effectiveness of health education module on study participants about prevention and control of hypertension (HTN) and the effectiveness of child as a health educator on parents' knowledge about prevention and control of HTN.
MATERIALS AND METHODS
This quasi-experimental study was conducted with a control group among high school students in two urban secondary schools. There were 110 students and 100 parents each in the intervention and control groups. Modular training with interactive teaching-learning methods was conducted for students in the intervention group. They, in turn, educated their parents.
RESULTS
Postintervention, the study results showed a higher median for various domains in the intervention group as compared to the control group among both students and parents. On applying Mann-Whitney test, this difference was statistically significant with P < 0.001.
CONCLUSION
The increase in the knowledge of parents belonging to the intervention group suggests the effective transfer of knowledge from the students to their parents.",2020,"RESULTS
Postintervention, the study results showed a higher median for various domains in the intervention group as compared to the control group among both students and parents.","['parents regarding hypertension', 'high school students in two urban secondary schools', '110 students and 100 parents each in the intervention and control groups', 'school students of South India', 'children and adolescents']","['health education module', 'Modular training with interactive teaching-learning methods']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],110.0,0.0182782,"RESULTS
Postintervention, the study results showed a higher median for various domains in the intervention group as compared to the control group among both students and parents.","[{'ForeName': 'Utsav', 'Initials': 'U', 'LastName': 'Raj', 'Affiliation': 'Department of Community and Family Medicine, AIIMS, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Poonam Ramesh', 'Initials': 'PR', 'LastName': 'Naik', 'Affiliation': 'Department of Community Medicine, Yenepoya Medical College, Mangalore, Karnataka, India.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Nirgude', 'Affiliation': 'Department of Community Medicine, Yenepoya Medical College, Mangalore, Karnataka, India.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_543_19']
3483,32490026,Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial.,"Background
The widespread historical abandonment of lateral extra-articular procedures in anterior cruciate ligament (ACL) injuries occurred as a result of concerns about high rates of adverse events. Recently, the popularity of lateral extra-articular procedures has resurged, warranting an urgent evaluation of their safety profile.
Purpose/Hypothesis
The aim of this study was to perform an interim analysis of the ongoing SANTI randomized controlled trial to determine whether combined ACL and anterolateral ligament reconstruction (ACL + ALLR) is associated with an increased rate of adverse outcomes when compared with isolated ACL reconstruction (ACLR). The hypothesis was that there would be no significant difference between groups at a minimum follow-up of 1 year.
Study Design
Randomized controlled trial; Level of evidence, 1.
Methods
Recruitment commenced in November 2016. Patients scheduled for ACLR were randomized to either isolated ACLR (with bone-patellar tendon-bone [BPTB] autograft) or combined ACL + ALLR (with hamstring tendon autograft). All patients with a minimum follow-up of 1 year by March 2019 were included. The evaluated parameters included complications and reoperations, knee laxity parameters, range of motion, and scores on the Tegner, Lysholm, International Knee Documentation Committee (IKDC), and Knee injury and Osteoarthritis Outcome Score (KOOS) instruments.
Results
A total of 224 patients (112 in each group) with a mean ± SD follow-up of 12.3 ± 1.9 months (range, 12-19 months) formed the study population. A significantly higher rate of reoperation for cyclops syndrome was noted in the isolated ACLR group compared with the combined ACL + ALLR group (8.9% vs 0%, respectively; P = .0012). No significant differences were found in frequency of graft rupture (ACLR, 5.4%; ACL + ALLR, 0.9%; P = .1191), range of motion deficits, pain, or reoperation for meniscectomy between groups. No cases of postoperative infection, venous thromboembolism, or arthrofibrosis were seen. Subjective IKDC (81.2 vs 86.8; P = .0048), Lysholm (88 vs 92; P = .0131), and some components of the KOOS were significantly better in the combined ACL + ALLR group.
Conclusion
This study demonstrates no evidence of an increased risk of short-term adverse events after combined ACL + ALLR compared with isolated ACLR with BPTB graft.
Registration
NCT03740022 (ClinicalTrials.gov Identifier).",2020,"Subjective IKDC (81.2 vs 86.8; P = .0048), Lysholm (88 vs 92; P =","['224 patients (112 in each group) with a mean ± SD follow-up of 12.3 ± 1.9 months (range, 12-19 months) formed the study population', 'Patients scheduled for ACLR', 'anterior cruciate ligament (ACL) injuries', 'November 2016', 'All patients with a minimum follow-up of 1 year by March 2019 were included']","['isolated ACLR (with bone-patellar tendon-bone [BPTB] autograft) or combined ACL + ALLR', 'isolated ACL reconstruction (ACLR', 'combined ACL and anterolateral ligament reconstruction (ACL + ALLR', 'combined ACL + ALLR', 'Combined ACL and Anterolateral Reconstruction']","['complications and reoperations, knee laxity parameters, range of motion, and scores on the Tegner, Lysholm, International Knee Documentation Committee (IKDC), and Knee injury and Osteoarthritis Outcome Score (KOOS) instruments', 'postoperative infection, venous thromboembolism, or arthrofibrosis', 'frequency of graft rupture', 'rate of reoperation for cyclops syndrome', 'Subjective IKDC', 'KOOS', 'range of motion deficits, pain, or reoperation for meniscectomy', 'Adverse Outcomes']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0547071', 'cui_str': 'Ligament reconstruction'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1142253', 'cui_str': 'Arthrofibrosis'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0266667', 'cui_str': 'Cyclops'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",224.0,0.142773,"Subjective IKDC (81.2 vs 86.8; P = .0048), Lysholm (88 vs 92; P =","[{'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Sonnery-Cottet', 'Affiliation': 'Centre Orthopédique Santy, Hôpital Privé Jean Mermoz, FIFA Medical Centre of Excellence, Groupe Ramsay GDS, Lyon, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pioger', 'Affiliation': 'Centre Orthopédique Santy, Hôpital Privé Jean Mermoz, FIFA Medical Centre of Excellence, Groupe Ramsay GDS, Lyon, France.'}, {'ForeName': 'Thais Dutra', 'Initials': 'TD', 'LastName': 'Vieira', 'Affiliation': 'Centre Orthopédique Santy, Hôpital Privé Jean Mermoz, FIFA Medical Centre of Excellence, Groupe Ramsay GDS, Lyon, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Franck', 'Affiliation': 'Centre Orthopédique Santy, Hôpital Privé Jean Mermoz, FIFA Medical Centre of Excellence, Groupe Ramsay GDS, Lyon, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kajetanek', 'Affiliation': 'Centre Orthopédique Santy, Hôpital Privé Jean Mermoz, FIFA Medical Centre of Excellence, Groupe Ramsay GDS, Lyon, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Fayard', 'Affiliation': 'Centre Orthopédique Santy, Hôpital Privé Jean Mermoz, FIFA Medical Centre of Excellence, Groupe Ramsay GDS, Lyon, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Thaunat', 'Affiliation': 'Centre Orthopédique Santy, Hôpital Privé Jean Mermoz, FIFA Medical Centre of Excellence, Groupe Ramsay GDS, Lyon, France.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Saithna', 'Affiliation': 'Sano Orthopedics, Advanced Orthopedics and Sports Medicine, Kansas City, Missouri, USA.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120918490']
3484,32490050,Clinical Outcomes of Intramedullary and Extramedullary Fixation in Unstable Intertrochanteric Fractures: A Randomized Clinical Trial.,"Background
The best method for repairing intertrochanteric fractures is still controversial. The fixation methods include extramedullary (EM) and intramedullary (IM). Studies that compare IM and EM fixations for unstable hip fractures are rare. In this study, our goal was to compare the efficacy of EM and IM fixation in treatment of unstable intertrochanteric fractures.
Methods
A total of 113 patients with unstable intertrochanteric were randomized in this cohort study between March 2016 and June 2018 in trauma center of Kashani and Alzahra Hospitals, Isfahan, Iran. The patients were followed for a period of 12 months with sequential clinical and imaging evaluations. Baseline data were recorded at the time of injury. Radiographs were evaluated immediately post-operatively and at the scheduled follow-up intervals.
Results
A total of 20 of patients were excluded during the study and finally 93 patients (43 males and 50 females) with mean age of 62.74±16.4 completed the follow-up sessions. Mann-Whitney test indicated a significant difference in tip-apex distance between the two groups. While the two groups were homogeneous in the baseline LEM score, it was not significantly different between two groups after 1 and 3 months of surgery as well. However, the LEM score was significantly higher in IM group after 6 and 12 months of surgery.
Conclusion
According to our findings, IM nails (such as the cephalomedullary nail) afforded more advantages over EM devices (such as the DHS and DCS) in the treatment of unstable intertrochanteric fractures. Our results indicated that the final LEM scores as well as the time to union were better in IM fixation group.",2020,"While the two groups were homogeneous in the baseline LEM score, it was not significantly different between two groups after 1 and 3 months of surgery as well.","['Unstable Intertrochanteric Fractures', '113 patients with unstable intertrochanteric were randomized in this cohort study between March 2016 and June 2018 in trauma center of Kashani and Alzahra Hospitals, Isfahan, Iran', 'A total of 20 of patients were excluded during the study and finally 93 patients (43 males and 50 females) with mean age of 62.74±16.4 completed the follow-up sessions']","['Intramedullary and Extramedullary Fixation', 'IM and EM fixations', 'EM and IM fixation']","['baseline LEM score', 'tip-apex distance', 'LEM score', 'final LEM scores', 'extramedullary (EM) and intramedullary (IM']","[{'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0115922', 'cui_str': 'endogenous pyrogen'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}]",113.0,0.0334783,"While the two groups were homogeneous in the baseline LEM score, it was not significantly different between two groups after 1 and 3 months of surgery as well.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Andalib', 'Affiliation': 'Department of Orthopedics, Alzahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Etemadifar', 'Affiliation': 'Department of Orthopedics, Alzahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Yavari', 'Affiliation': 'Department of Orthopedics, Alzahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",The archives of bone and joint surgery,['10.22038/abjs.2019.34942.1919']
3485,32490838,The Use of a Smartphone App and an Activity Tracker to Promote Physical Activity in the Management of Chronic Obstructive Pulmonary Disease: Randomized Controlled Feasibility Study.,"BACKGROUND
Chronic obstructive pulmonary disease (COPD) is highly prevalent and significantly affects the daily functioning of patients. Self-management strategies, including increasing physical activity, can help people with COPD have better health and a better quality of life. Digital mobile health (mHealth) techniques have the potential to aid the delivery of self-management interventions for COPD. We developed an mHealth intervention (Self-Management supported by Assistive, Rehabilitative, and Telehealth technologies-COPD [SMART-COPD]), delivered via a smartphone app and an activity tracker, to help people with COPD maintain (or increase) physical activity after undertaking pulmonary rehabilitation (PR).
OBJECTIVE
This study aimed to determine the feasibility and acceptability of using the SMART-COPD intervention for the self-management of physical activity and to explore the feasibility of conducting a future randomized controlled trial (RCT) to investigate its effectiveness.
METHODS
We conducted a randomized feasibility study. A total of 30 participants with COPD were randomly allocated to receive the SMART-COPD intervention (n=19) or control (n=11). Participants used SMART-COPD throughout PR and for 8 weeks afterward (ie, maintenance) to set physical activity goals and monitor their progress. Questionnaire-based and physical activity-based outcome measures were taken at baseline, the end of PR, and the end of maintenance. Participants, and health care professionals involved in PR delivery, were interviewed about their experiences with the technology.
RESULTS
Overall, 47% (14/30) of participants withdrew from the study. Difficulty in using the technology was a common reason for withdrawal. Participants who completed the study had better baseline health and more prior experience with digital technology, compared with participants who withdrew. Participants who completed the study were generally positive about the technology and found it easy to use. Some participants felt their health had benefitted from using the technology and that it assisted them in achieving physical activity goals. Activity tracking and self-reporting were both found to be problematic as outcome measures of physical activity for this study. There was dissatisfaction among some control group members regarding their allocation.
CONCLUSIONS
mHealth shows promise in helping people with COPD self-manage their physical activity levels. mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD. Simplicity and usability were more important for engagement with the SMART-COPD intervention than personalization; therefore, the intervention should be simplified for future use. Future evaluation will require consideration of individual factors and their effect on mHealth efficacy and use; within-subject comparison of step count values; and an opportunity for control group participants to use the intervention if an RCT were to be carried out. Sample size calculations for a future evaluation would need to consider the high dropout rates.",2020,mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD.,"['Chronic obstructive pulmonary disease (COPD', '30 participants with COPD', 'Participants, and health care professionals involved in PR delivery, were interviewed about their experiences with the technology', 'Chronic Obstructive Pulmonary Disease', 'Participants who completed the study had better baseline health and more prior experience with digital technology, compared with participants who withdrew']","['SMART-COPD intervention', 'Smartphone App and an Activity Tracker to Promote Physical Activity']","['Simplicity and usability', 'Questionnaire-based and physical activity-based outcome measures']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1454365', 'cui_str': 'Simplicity (adhesive)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",30.0,0.0578692,mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD.,"[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Bentley', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Powell', 'Affiliation': 'School of Education, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Potter', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'School of Human Sciences, The University of Derby, Derby, United Kingdom.'}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Mountain', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Yvonne Kiera', 'Initials': 'YK', 'LastName': 'Bartlett', 'Affiliation': 'Manchester Centre for Health Psychology, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Farwer', 'Affiliation': 'Library, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Integrated Community Care Team, Sheffield, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Cresswell', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Dunn', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Hawley', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/16203']
3486,32488010,Motor imagery training speeds up gait recovery and decreases the risk of falls in patients submitted to total knee arthroplasty.,"With Motor imagery (MI), movements are mentally rehearsed without overt actions; this procedure has been adopted in motor rehabilitation, primarily in brain-damaged patients. Here we rather tested the clinical potentials of MI in purely orthopaedic patients who, by definition, should maximally benefit of mental exercises because of their intact brain. To this end we studied the recovery of gait after total knee arthroplasty and evaluated whether MI combined with physiotherapy could speed up the recovery of gait and even limit the occurrence of future falls. We studied 48 patients at the beginning and by the end of the post-surgery residential rehabilitation program: half of them completed a specific MI training supported by computerized visual stimulation (experimental group); the other half performed a non-motoric cognitive training (control group). All patients also had standard physiotherapy. By the end of the rehabilitation, the experimental group showed a better recovery of gait and active knee flexion-extension movements, and less pain. The number of falls or near falls after surgery was significantly lower in the experimental group. These results show that MI can improve gait abilities and limit future falls in orthopaedic patients, without collateral risks and with limited costs.",2020,"By the end of the rehabilitation, the experimental group showed a better recovery of gait and active knee flexion-extension movements, and less pain.","['All patients also had standard physiotherapy', 'patients submitted to total knee arthroplasty', '48 patients at the beginning and by the end of the post-surgery residential rehabilitation program']","['MI combined with physiotherapy', 'Motor imagery (MI', 'specific MI training supported by computerized visual stimulation (experimental group); the other half performed a non-motoric cognitive training (control group']","['recovery of gait and active knee flexion-extension movements, and less pain', 'gait abilities and limit future falls', 'risk of falls', 'number of falls or near falls after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",48.0,0.0174975,"By the end of the rehabilitation, the experimental group showed a better recovery of gait and active knee flexion-extension movements, and less pain.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zapparoli', 'Affiliation': 'Psychology Department and NeuroMI - Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy. laura.zapparoli@unimib.it.'}, {'ForeName': 'Lucia Maria', 'Initials': 'LM', 'LastName': 'Sacheli', 'Affiliation': 'Psychology Department and NeuroMI - Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Seghezzi', 'Affiliation': 'Psychology Department and NeuroMI - Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Preti', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Stucovitz', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Negrini', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Catia', 'Initials': 'C', 'LastName': 'Pelosi', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ursino', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Banfi', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Eraldo', 'Initials': 'E', 'LastName': 'Paulesu', 'Affiliation': 'Psychology Department and NeuroMI - Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy. eraldo.paulesu@unimib.it.'}]",Scientific reports,['10.1038/s41598-020-65820-5']
3487,32488207,"Correction: ""Topical treatment for acute phase Peyronie's disease utilizing a new gel, H100: a randomized, prospective, placebo-controlled pilot study"".",An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0351083,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Twidwell', 'Affiliation': 'Urology Associates, Robbinsdale, MN, USA. jt4huskers@gmail.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Levine', 'Affiliation': 'Rush Medical College, Chicago, IL, USA.'}]",International journal of impotence research,['10.1038/s41443-020-0303-z']
3488,32488233,"An Afternoon Hummus Snack Affects Diet Quality, Appetite, and Glycemic Control in Healthy Adults.","BACKGROUND
Snacking continues to be a major component in the dietary patterns of most Americans despite conflicting evidence surrounding snacking healthfulness. Low-sugar, highly nutritive snacks, such as hummus, can lead to improvements in diet quality, appetite, and glycemic control.
OBJECTIVES
The purpose of the study was to examine the effects of afternoon snacking on diet quality, appetite, and glycemic control in healthy adults.
METHODS
Thirty-nine adults (age: 26 ± 1 y; BMI: 24.4 ± 0.5 kg/m2) randomly completed the following afternoon snack patterns for 6 d/pattern: hummus and pretzels [HUMMUS; 240 kcal; 6 g protein, 31 g carbohydrate (2 g sugar), 11 g fat]; granola bars [BARS; 240 kcal; 4 g protein, 38 g carbohydrate (16 g sugar), 9 g fat]; or no snacking (NO SNACK). On day 7 of each pattern, a standardized breakfast and lunch were provided. The respective snack was provided to participants 3 h after lunch, and appetite, satiety, and mood questionnaires were completed throughout the afternoon. At 3 h postsnack, a standardized dinner was consumed, and an evening snack cooler was provided to be consumed, ad libitum at home, throughout the evening. Lastly, 24 h continuous glucose monitoring was performed.
RESULTS
HUMMUS reduced subsequent snacking on desserts by ∼20% compared with NO SNACK (P = 0.001) and BARS (P < 0.001). HUMMUS led to greater dietary compensation compared with BARS (122 ± 31% compared with 72 ± 32%, respectively; P < 0.05). HUMMUS reduced indices of appetite (i.e., hunger, desire to eat, and prospective food consumption) by ∼70% compared with NO SNACK (all P < 0.05), whereas BARS did not. Additionally, satiety was ∼30% greater following HUMMUS and BARS compared with NO SNACK (both P < 0.005) with no differences between snacks. Lastly, HUMMUS reduced afternoon blood glucose concentrations by ∼5% compared with BARS (P < 0.05).
CONCLUSIONS
Acute consumption of a low-sugar, afternoon hummus snack improved diet quality and selected indices of appetite, satiety, and glycemic control in healthy adults. Long-term trials assessing the effects of hummus snacking on health outcomes are warranted.",2020,"HUMMUS led to greater dietary compensation compared with BARS (122 ± 31% compared with 72 ± 32%, respectively; P < 0.05).","['Healthy Adults', 'healthy adults', 'Thirty-nine adults (age: 26\xa0±']","['hummus snacking', 'afternoon snacking', 'afternoon snack patterns for 6 d/pattern: hummus and pretzels [HUMMUS; 240 kcal; 6\xa0g protein, 31\xa0g carbohydrate (2\xa0g sugar), 11\xa0g fat]; granola bars [BARS; 240 kcal; 4\xa0g protein, 38\xa0g carbohydrate (16\xa0g sugar), 9\xa0g fat]; or no snacking (NO SNACK']","['appetite (i.e., hunger, desire to eat, and prospective food consumption', 'BARS', 'satiety', 'dietary compensation', 'afternoon blood glucose concentrations', 'diet quality, appetite, and glycemic control', 'diet quality and selected indices of appetite, satiety, and glycemic control', 'appetite, satiety, and mood questionnaires', 'Diet Quality, Appetite, and Glycemic Control']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0453218', 'cui_str': 'Hummus'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0458214', 'cui_str': 'Pretzels'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0456636', 'cui_str': '16G'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",3.0,0.0284081,"HUMMUS led to greater dietary compensation compared with BARS (122 ± 31% compared with 72 ± 32%, respectively; P < 0.05).","[{'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Reister', 'Affiliation': 'Department of Nutrition Science; Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leidy', 'Affiliation': 'Department of Nutritional Sciences and Department of Pediatrics; University of Texas at Austin; Austin, TX, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa139']
3489,32488238,"Changes in Muscle Tone, Function, and Pain in the Chronic Hemiparetic Shoulder after Dry Needling Within or Outside Trigger Points in Stroke Patients: A Crossover Randomized Clinical Trial.","OBJECTIVES
To investigate the effects of applying dry needling into a trigger point (TrP) or non-TrP area in people who have suffered a stroke and to investigate if the effects of dry needling are maintained at six-week follow-up.
METHODS
A controlled, repeated-measures, crossover, double-blinded randomized trial was conducted. Nineteen patients with hemiparetic shoulder pain after a stroke event were randomly assigned to receive a single multimodal treatment session combined with TrP dry needling or non-TrP dry needling. The neuro-rehabilitation session included modulatory interventions targeting the central nervous system. Spasticity (Modified Ashworth Scale), shoulder pain intensity (numerical pain rate scale, 0-10), and upper extremity function (Motor Evaluation Scale for Upper Extremity in Stroke [MESUPES], Reaching Performance Scale [RPS]) were assessed before (baseline) and one, two, three, four, five, and six weeks after the treatment session by a blinded assessor. All participants received both sessions in a randomized order where they were followed up for six weeks before receiving the opposite treatment and then followed up for another six weeks.
RESULTS
Changes in muscle tone (all P > 0.266) and upper extremity function (MESUPES: F = 0.544, P = 0.465; RPS close task: F = 0.820, P = 0.371; RPS far task: 0.830, P = 0.368) were similar after both interventions at all follow-up periods. The decrease in shoulder pain was higher within the TrP dry needling group as compared with the non-TrP dry needling group, particularly at two and four weeks (P = 0.01).
CONCLUSIONS
The effect of dry needling on muscle tone (spasticity) and upper extremity function is not related to its application in or outside of a TrP area. The effect of dry needling on shoulder pain was slightly superior when applied over a TrP in poststroke people. These effects were maintained six weeks after treatment.",2020,"The decrease in shoulder pain was higher within the TrP dry needling group as compared with the non-TrP dry needling group, particularly at two and four weeks (P = 0.01).
","['people who have suffered a stroke', 'Nineteen patients with hemiparetic shoulder pain after a stroke event', 'Stroke Patients']","['dry needling', 'dry needling into a trigger point (TrP', 'single multimodal treatment session combined with TrP dry needling or non-TrP dry needling']","['muscle tone (spasticity) and upper extremity function', 'Spasticity (Modified Ashworth Scale), shoulder pain intensity (numerical pain rate scale, 0-10), and upper extremity function (Motor Evaluation Scale for Upper Extremity in Stroke [MESUPES], Reaching Performance Scale [RPS', 'muscle tone', 'upper extremity function', 'shoulder pain', 'Muscle Tone, Function, and Pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",19.0,0.133599,"The decrease in shoulder pain was higher within the TrP dry needling group as compared with the non-TrP dry needling group, particularly at two and four weeks (P = 0.01).
","[{'ForeName': 'Alma R', 'Initials': 'AR', 'LastName': 'Hernández-Ortíz', 'Affiliation': 'Escuela Internacional de Doctorado, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Ponce-Luceño', 'Affiliation': 'Centro de Atención Integral Para Personas con Daño Cerebral, Polibea Sur, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sáez-Sánchez', 'Affiliation': 'Centro de Atención Integral Para Personas con Daño Cerebral, Polibea Sur, Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'García-Sánchez', 'Affiliation': 'Centro de Atención Integral Para Personas con Daño Cerebral, Polibea Sur, Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'de-la-Llave-Rincón', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa132']
3490,32488245,Effectiveness of a Khorasan Wheat-Based Replacement on Pain Symptoms and Quality of Life in Patients with Fibromyalgia.,"OBJECTIVE
To investigate the effects of a replacement diet with Khorasan wheat products in patients with fibromyalgia, in comparison with a similar replacement diet with control products made from organic semi-whole-grain modern wheat.
DESIGN
Randomized, double-blinded crossover trial.
SETTING
Outpatient clinic.
SUBJECTS
Twenty subjects (19 female and one male, mean age = 48.9 ± 12.3 years) with fibromyalgia.
METHODS
Participants were randomly assigned to consume either Khorasan or control wheat products (pasta, bread, crackers, biscuits) for eight weeks and then crossed. Validated self-administered questionnaires were collected from each subject at the beginning and end of each intervention period.
RESULTS
A general linear model for repeated measurement, adjusted for potential confounders, showed that the overall score reported from each questionnaire improved after both intervention and control periods, but the effect was more evident after the intervention with Khorasan. In particular, a statistically significant difference in Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ) was observed, which decreased significantly by 21.5% and 11.7% respectively, only after the Khorasan period, while no statistically significant variations were reported after the control period. Similarly, FM Impact Questionnaire scores decreased significantly only after the Khorasan period, with a reduction that was significantly different between the intervention and control periods (-22.5% vs -0.3%, P = 0.037). The improvement was even greater in people with higher symptom severity.
CONCLUSIONS
A dietary intervention with Khorasan wheat products seems to benefit patients with fibromyalgia, especially those with greater symptom severity.",2020,"In particular, a statistically significant difference in Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ) was observed, which decreased significantly by 21.5% and 11.7% respectively, only after the Khorasan period, while no statistically significant variations were reported after the control period.","['Twenty subjects (19 female and one male, mean age = 48.9 ± 12.3\u2009years) with fibromyalgia', 'patients with fibromyalgia, in comparison with a similar replacement diet with control products made from organic semi-whole-grain modern wheat', 'Patients with Fibromyalgia', 'Participants', 'Outpatient clinic']","['Khorasan or control wheat products (pasta, bread, crackers, biscuits', 'replacement diet with Khorasan wheat products', 'Khorasan Wheat-Based Replacement']","['FM Impact Questionnaire scores', 'Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ', 'Pain Symptoms and Quality of Life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3853226', 'cui_str': 'Khorasan wheat'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",20.0,0.0494743,"In particular, a statistically significant difference in Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ) was observed, which decreased significantly by 21.5% and 11.7% respectively, only after the Khorasan period, while no statistically significant variations were reported after the control period.","[{'ForeName': 'Giuditta', 'Initials': 'G', 'LastName': 'Pagliai', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Colombini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dinu', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Whittaker', 'Affiliation': 'Department of Agrifood Production and Environmental Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Masoni', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Danza', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Amedei', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Ballerini', 'Affiliation': 'Multidisciplinary Center for Pain Therapy, Reference Center for Fibromyalgia, Piero Palagi Hospital, USL Toscana Centro, Florence, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Benedettelli', 'Affiliation': 'Department of Agrifood Production and Environmental Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sofi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa134']
3491,32488378,Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: baseline results in a cluster preference randomised controlled trial.,"PURPOSE
The main aim of this paper is to present baseline demographic and clinical characteristics and HRQOL in the two groups of the Patient Concerns Inventory (PCI) trial. The baseline PCI data will also be described.
METHODS
This is a pragmatic cluster preference randomised control trial with 15 consultant clusters from two sites either 'using' (n = 8) or 'not using' (n = 7) the PCI at a clinic for all of their trial patients. The PCI is a 56-item prompt list that helps patients raise concerns that otherwise might be missed. Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments).
RESULTS
From 511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days. At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment. These exceptions were cluster (consultant) related to Maxillofacial and ENT consultants seeing different types of cases. Consultation times were similar, with PCI group times taking about 1 min longer on average (95% CL for the difference between means was from - 0.7 to + 2.2 min).
CONCLUSION
Using the PCI in routine post-treatment head and neck cancer clinics do not elongate consultations. Recruitment has finished but 12-month follow-up is still ongoing.",2020,"At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment.","['Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments', 'head and neck cancer patients', ""15 consultant clusters from two sites either 'using' (n\u2009=\u20098) or 'not using' (n\u2009=\u20097) the PCI at a clinic for all of their trial patients"", '511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days']",[],"['Consultation times', 'Improving quality of life']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",511.0,0.201374,"At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment.","[{'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Rogers', 'Affiliation': 'Faculty of Health and Social Care, Edge Hill University, Ormskirk, L39 4QP, UK. simonn.rogers@aintree.nhs.uk.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Allmark', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Fazilet', 'Initials': 'F', 'LastName': 'Bekiroglu', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation (CHEME), School of Healthcare Sciences, College of Health and Behavioural Sciences (CoHaBS), Ardudwy Building, Normal Site, Bangor University, Bangor, UK.'}, {'ForeName': 'Gillon', 'Initials': 'G', 'LastName': 'Fabbroni', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Flavel', 'Affiliation': ', Guildford, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Highet', 'Affiliation': 'Liverpool Head and Neck Clinical Trials, Clinical Sciences Building, University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Michael W S', 'Initials': 'MWS', 'LastName': 'Ho', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Gerald M', 'Initials': 'GM', 'LastName': 'Humphris', 'Affiliation': 'School of Medicine, Medical and Biological Sciences, North Haugh, St Andrews, UK.'}, {'ForeName': 'Terry M', 'Initials': 'TM', 'LastName': 'Jones', 'Affiliation': 'Liverpool Head and Neck Centre, University of Liverpool, Cancer Research Centre, 200 London Road, Liverpool, L3 9GA, UK.'}, {'ForeName': 'Owais', 'Initials': 'O', 'LastName': 'Khattak', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lancaster', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Loh', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Lowe', 'Affiliation': 'Astraglobe Ltd, Congleton, Cheshire, UK.'}, {'ForeName': 'Cher', 'Initials': 'C', 'LastName': 'Lowies', 'Affiliation': 'Liverpool Head and Neck Clinical Trials, Clinical Sciences Building, University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Macareavy', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moor', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Ong', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Prasai', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Roland', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Cherith', 'Initials': 'C', 'LastName': 'Semple', 'Affiliation': 'Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co. Antrim, BT37 0QB, UK.'}, {'ForeName': 'Llinos Haf', 'Initials': 'LH', 'LastName': 'Spencer', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation (CHEME), School of Healthcare Sciences, College of Health and Behavioural Sciences (CoHaBS), Ardudwy Building, Normal Site, Bangor University, Bangor, UK.'}, {'ForeName': 'Sank', 'Initials': 'S', 'LastName': 'Tandon', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Oral and Maxillofacial Surgery Department, Bristol University, Lower Maudlin Street, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schache', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Kanatas', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06077-6']
3492,32488427,Physiologically Based Dissolution Testing in a Drug Development Process-a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions.,"Development of generic extended-release (ER) formulations is challenging. Especially under fed conditions, the risk of failure in bioequivalence trials is high because of long gastric residence times and susceptibility to food effects. We describe the development of a generic trazodone ER formulation that was aided with a biorelevant dissolution evaluation. Trazodone hydrochloride 300-mg monolithic matrix tablets were dissolved both in USP and EMA compliant conditions and in the StressTest device that simulated both physicochemical and mechanical conditions of the gastrointestinal passage. The final formulation was tested against the originator, Trittico XR 300 mg, in a randomized cross-over bioequivalence trial with 44 healthy volunteers, in agreement with EMA guidelines. Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2 factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests. The formulation was optimized by the addition of low-viscosity hypromellose and mannitol. The final formulation was approved for the bioequivalence trial. Calculated C max were 1.92 ± 0.77 and 1.92 ± 0.63 [μg/mL], AUC 0-t were 27.46 ± 8.39 and 29.96 ± 9.09 [μg∙h/mL], and AUC 0-∞ were 28.22 ± 8.91 and 30.82 ± 9.41 [μg∙h/mL] for the originator and test formulations, respectively. The 90% confidence intervals of all primary pharmacokinetic parameters fell within the 80-125% range. In summary, biorelevant dissolution tests supported successful development of a generic trazodone ER formulation pharmaceutically equivalent with the originator under fed conditions. Employment of biorelevant dissolution tests may decrease the risk of failure in bioequivalence trials of ER formulations.",2020,"Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2 factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests.",['44 healthy volunteers'],"['trazodone', 'generic trazodone ER formulation', 'Trazodone ER Formulations', 'Trazodone hydrochloride', 'low-viscosity hypromellose and mannitol']",['dissolution kinetics'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0282369', 'cui_str': 'Trazodone hydrochloride'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}]",44.0,0.107498,"Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2 factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests.","[{'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Danielak', 'Affiliation': 'Department of Physical Pharmacy and Pharmacokinetics, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Święcickiego st, 60-781, Poznań, Poland. danielak@ump.edu.pl.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Milanowski', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Grunwaldzka st, 60-780, Poznań, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Wentowski', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nogowska', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Kątny', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rogowski', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Konwicki', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Puk', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Pieczuro', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Bawiec', 'Affiliation': 'Institute of Computer Engineering, Control and Robotics, Wroclaw University of Technology, 27 Wybrzeże Wyspańskiego st, 50-370, Wrocław, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Garbacz', 'Affiliation': 'Physiolution GmbH, Walther-Rathenau Strasse 49a, 17489, Greifswald, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Lulek', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Grunwaldzka st, 60-780, Poznań, Poland.'}]",AAPS PharmSciTech,['10.1208/s12249-020-01662-8']
3493,32488435,Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial.,"PURPOSE
Lymphedema associated with head and neck cancer (HNC) therapy causes adverse clinical outcomes. Standard treatment includes professionally administered complete decongestive therapy (CDT). Cost and availability of trained therapists are known barriers to therapy. Advanced pneumatic compression devices (APCD) may address these issues. A randomized, wait-list controlled trial was undertaken to evaluate an APCD in post-treatment HNC patients with lymphedema.
MATERIAL AND METHODS
Eligible patients had completed treatment for HNC, were disease free, and had lymphedema at enrollment. Participants were randomized to wait-list lymphedema self-management (standard of care) or lymphedema self-management plus the use of the APCD bid. Safety (CTCAE V4.0) and feasibility were primary endpoints; secondary endpoints included efficacy measure by objective examination and patient reported outcomes (symptoms, quality of life, function), adherence barriers, and satisfaction. Assessments were conducted at baseline and weeks 4 and 8.
RESULTS
Forty-nine patients were enrolled (wait-list n = 25; intervention n = 24). In total, forty-three patients completed the study. No device-related Serious Adverse Events were reported. Most patients used the APCD once per day, instead of the prescribed twice per day, citing time related factors as barriers to use. APCD use was associated with significant improvement in perceived ability to control lymphedema (p = 0.003) and visible external swelling (front view p < 0.001, right view p = 0.004, left p = 0.005), as well as less reported pain.
CONCLUSION
This trial supports the safety and feasibility of the APCD for the treatment of secondary lymphedema in head and neck cancer patients. In addition, preliminary data supports efficacy.",2020,"APCD use was associated with significant improvement in perceived ability to control lymphedema (p = 0.003) and visible external swelling (front view p < 0.001, right view p = 0.004, left p = 0.005), as well as less reported pain.
","['Forty-nine patients were enrolled (wait-list', 'Eligible patients had completed treatment for HNC, were disease free, and had lymphedema at enrollment', 'HNC patients with lymphedema', 'lymphedema of the head and neck', 'secondary lymphedema in head and neck cancer patients']","['Advanced pneumatic compression', 'wait-list lymphedema self-management (standard of care) or lymphedema self-management plus the use of the APCD bid', 'decongestive therapy (CDT', 'APCD', 'Advanced pneumatic compression devices (APCD']","['efficacy measure by objective examination and patient reported outcomes (symptoms, quality of life, function), adherence barriers, and satisfaction', 'visible external swelling', 'perceived ability to control lymphedema', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0265191', 'cui_str': 'Chronic acquired lymphedema'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",49.0,0.166415,"APCD use was associated with significant improvement in perceived ability to control lymphedema (p = 0.003) and visible external swelling (front view p < 0.001, right view p = 0.004, left p = 0.005), as well as less reported pain.
","[{'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'Vanderbilt School of Nursing, Vanderbilt University School of Nursing, 461 21st Avenue South, Nashville, TN, 37240, USA. sheila.ridner@vanderbilt.edu.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'Vanderbilt School of Nursing, Vanderbilt University Medical Center, 1211 Medical Center Drive, Nashville, TN, 37232, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'University of Pennsylvania School of Nursing, 418 Curie Boulevard, Philadelphia, PA, 19104-4217, USA.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Ettema', 'Affiliation': 'Southern Illinois University School of Medicine, P.O. Box 19620, Springfield, IL, 62794-9620, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Murphy', 'Affiliation': 'Vanderbilt University Medical Center, 1211 Medical Center Drive, Nashville, TN, 37232, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05540-8']
3494,32488456,Negative parenting behaviour as a mediator of the effects of telephone-assisted self-help for parents of pharmacologically treated children with attention-deficit/hyperactivity disorder.,"A previous randomised controlled trial demonstrated the effects of a telephone-assisted self-help (TASH) intervention for parents of pharmacologically treated children with attention-deficit/hyperactivity disorder (ADHD) on ADHD symptoms, oppositional symptoms, functional impairment, and negative parenting behaviour (per-protocol analyses). In the current study, we examined whether changes in positive and negative parenting behaviour mediated the effects on symptoms and impairment. Parents in an enhancement group (n = 51) participated in a 12-month TASH intervention (eight booklets plus up to 14 telephone consultations) as an adjunct to routine clinical care, whereas parents in a waitlist control group (n = 52) received routine clinical care only. Parents completed measures of child symptoms, child functional impairment, and parenting behaviour at baseline, at 6 months, and at 12 months. The mediating effects of parenting behaviour were examined using regression analyses. Per-protocol analyses (n = 74) revealed a significant indirect intervention effect on functional impairment through negative parenting behaviour at 6 months as well as indirect intervention effects on oppositional symptoms and functional impairment through negative parenting behaviour at 12 months. The indirect effect on ADHD symptoms through negative parenting behaviour at 12 months just failed to reach significance. The analyses yielded no indirect intervention effects through positive parenting behaviour. The study provides some, albeit limited, support for the importance of changes in negative parenting behaviour to achieve changes in symptoms and functional impairment during parent training. In consideration of the inconsistent results of previous studies concerning the mediating role of positive and negative parenting behaviour, further research is required to better understand the mechanisms of change during parent training, also including other possible mediators like parenting stress and parental self-efficacy.",2020,"A previous randomised controlled trial demonstrated the effects of a telephone-assisted self-help (TASH) intervention for parents of pharmacologically treated children with attention-deficit/hyperactivity disorder (ADHD) on ADHD symptoms, oppositional symptoms, functional impairment, and negative parenting behaviour (per-protocol analyses).","['parents of pharmacologically treated children with attention-deficit/hyperactivity disorder', 'parents of pharmacologically treated children with attention-deficit/hyperactivity disorder (ADHD) on ADHD symptoms, oppositional symptoms, functional impairment, and negative parenting behaviour (per-protocol analyses']","['TASH intervention (eight booklets plus up to 14 telephone consultations) as an adjunct to routine clinical care, whereas parents in a waitlist control group (n\u2009=\u200952) received routine clinical care only', 'telephone-assisted self-help (TASH) intervention', 'telephone-assisted self-help']","['oppositional symptoms and functional impairment through negative parenting behaviour', 'child symptoms, child functional impairment, and parenting behaviour', 'functional impairment through negative parenting behaviour', 'ADHD symptoms through negative parenting behaviour']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]",,0.0359213,"A previous randomised controlled trial demonstrated the effects of a telephone-assisted self-help (TASH) intervention for parents of pharmacologically treated children with attention-deficit/hyperactivity disorder (ADHD) on ADHD symptoms, oppositional symptoms, functional impairment, and negative parenting behaviour (per-protocol analyses).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dose', 'Affiliation': 'School for Child and Adolescent Cognitive Behavior Therapy (AKiP), Faculty of Medicine and University Hospital Cologne, University of Cologne, Pohligstr. 9, 50969, Cologne, Germany. Christina.dose@uk-koeln.de.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hautmann', 'Affiliation': 'School for Child and Adolescent Cognitive Behavior Therapy (AKiP), Faculty of Medicine and University Hospital Cologne, University of Cologne, Pohligstr. 9, 50969, Cologne, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Bürger', 'Affiliation': 'School for Child and Adolescent Cognitive Behavior Therapy (AKiP), Faculty of Medicine and University Hospital Cologne, University of Cologne, Pohligstr. 9, 50969, Cologne, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schürmann', 'Affiliation': 'School for Child and Adolescent Cognitive Behavior Therapy (AKiP), Faculty of Medicine and University Hospital Cologne, University of Cologne, Pohligstr. 9, 50969, Cologne, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Döpfner', 'Affiliation': 'School for Child and Adolescent Cognitive Behavior Therapy (AKiP), Faculty of Medicine and University Hospital Cologne, University of Cologne, Pohligstr. 9, 50969, Cologne, Germany.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01565-w']
3495,32488923,Ultra Rapid Lispro Improves Postprandial Glucose Control Compared With Lispro in Patients With Type 1 Diabetes: Results from the 26-Week PRONTO-T1D Study.,"AIMS
In this 26-week, treat-to-target, phase 3 trial, we evaluated the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes.
MATERIALS AND METHODS
After an 8-week lead-in to optimize basal insulin glargine or degludec, patients were randomized to double-blind mealtime URLi (n=451) or lispro (n=442), or open-label postmeal URLi (n=329). The primary endpoint was change from baseline HbA1c to 26 weeks (noninferiority margin 0.4%), with multiplicity adjusted objectives for postprandial glucose (PPG) excursions after a meal test.
RESULTS
Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) mealtime URLi, -0.08% [95% CI -0.16, 0.00], and postmeal URLi +0.13% [0.04, 0.22]; with a significantly higher endpoint HbA1c for postmeal URLi versus lispro (p=0.003). Mealtime URLi was superior to lispro in reducing 1- and 2-h PPG excursions during the meal test: ETD -1.55 mmol/L [95%CI -1.96, -1.14] at 1-h and -1.73 mmol/L [-2.28, -1.18] at 2-h (both p<0.001). The rate and incidence of severe, documented and postprandial hypoglycaemia (<3.0 mmol/L) was similar between treatments, but mealtime URLi demonstrated a 37% lower rate in the period >4 h after meals, (p=0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on postmeal URLi, and 0.2% on lispro. Overall, the incidence of treatment-emergent adverse events was similar between treatments.
CONCLUSIONS
URLi provided good glycaemic control, with noninferiority to lispro confirmed for both mealtime and postmeal URLi, while superior PPG control was demonstrated with mealtime dosing. This article is protected by copyright. All rights reserved.",2020,"Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) mealtime URLi, -0.08% [95% CI -0.16, 0.00], and postmeal URLi +0.13% [0.04, 0.22]; with a significantly higher endpoint HbA1c for postmeal URLi versus lispro (p=0.003).","['adults with type 1 diabetes', 'Patients With Type 1 Diabetes']","['ultra rapid lispro (URLi) versus lispro', 'Ultra Rapid Lispro', 'double-blind mealtime URLi (n=451) or lispro (n=442), or open-label postmeal URLi', 'Lispro']","['Postprandial Glucose Control', 'incidence of treatment-emergent adverse events', 'rate and incidence of severe, documented and postprandial hypoglycaemia', 'Injection site reactions', 'postprandial glucose (PPG) excursions', '1- and 2-h PPG excursions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0271710', 'cui_str': 'Reactive hypoglycemia'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]",,0.0808552,"Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) mealtime URLi, -0.08% [95% CI -0.16, 0.00], and postmeal URLi +0.13% [0.04, 0.22]; with a significantly higher endpoint HbA1c for postmeal URLi versus lispro (p=0.003).","[{'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Klaff', 'Affiliation': 'Rainier CRC, Washington, USA.'}, {'ForeName': 'Dachuang', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Tobian', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}, {'ForeName': 'Junnosuke', 'Initials': 'J', 'LastName': 'Miura', 'Affiliation': ""Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Dahl', 'Affiliation': 'Gemeinschaftspraxis fur Innere Medizin und Diabetologie, Hamburg, Germany.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Lucas Research, North Carolina, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14100']
3496,32488934,"Does Pilates effect on depression status, pain, functionality, and quality of life in university students? A randomized controlled study.","PURPOSE
The aim of this study is to investigate the effects of Pilates exercise program on health-related quality of life, pain, functional level, and depression status in university students.
DESIGN AND METHODS
The exercise programs were carried out for 12 weeks. The scales of Nottingham Health Profile, Visual Analog Scale, Oswestry Disability Index, and Beck Depression Inventory were used at the baseline and after training.
FINDINGS
Exercise should be encouraged to reduce pain and depression and improve the quality of life in healthy university students. Both Pilates and therapeutic exercises approach can be preferred.
PRACTICE IMPLICATIONS
The results of this study show the inability to identify clear different effects from therapeutic exercises on university students for Pilates exercises.",2020,"The scales of Nottingham Health Profile, Visual Analog Scale, Oswestry Disability Index, and Beck Depression Inventory were used at the baseline and after training.
","['university students for Pilates exercises', 'university students', 'healthy university students']",['Pilates exercise program'],"['quality of life', 'depression status, pain, functionality, and quality of life', 'health-related quality of life, pain, functional level, and depression status', 'scales of Nottingham Health Profile, Visual Analog Scale, Oswestry Disability Index, and Beck Depression Inventory', 'pain and depression']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1321049', 'cui_str': 'Pilates exercise'}]","[{'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451339', 'cui_str': 'Nottingham health profile'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",,0.0312834,"The scales of Nottingham Health Profile, Visual Analog Scale, Oswestry Disability Index, and Beck Depression Inventory were used at the baseline and after training.
","[{'ForeName': 'Asuman', 'Initials': 'A', 'LastName': 'Saltan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Yalova University, Yalova, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Ankaralı', 'Affiliation': 'Department of Medical Informatics, School of Medicine and Biostatistics, Medeniyet University, Istanbul, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12547']
3497,32488980,Cognitive profiles of healthy siblings of first-episode schizophrenia patients.,"AIM
Cognitive deficit in psychotic illness is intensively studied, different cognitive subtypes have been suggested. In recent years, there has been an increase in the number of studies in patients with schizophrenia and their relatives searching for endophenotypes of the disease. The aim of our study was to investigate cognitive performance and cognitive subtypes in the siblings of the patients.
METHODS
Four groups of subjects were included: patients with a first episode of psychotic illness, the siblings of these patients, and two control groups. All the study subjects (N = 84) had a battery of neuropsychological tests that measured basic cognitive domains - memory, executive functions, attention, visual-spatial skills, language skills and psychomotor speed - administered to them. The data were assessed with pairwise t-tests for group comparisons. The siblings were distributed into three groups according to their cognitive performance: non-deficit, partial deficit, and global deficit. Subsequently, the patients were assigned into three groups corresponding to their siblings' performance.
RESULTS
Our results revealed attenuation of abstract thinking in the siblings compared to the controls. As expected, the patients showed impairment across all cognitive domains. The patients and siblings demonstrated similar profiles in each subtype, in the severity of their impairment, and in their patterns of cognitive performance.
CONCLUSIONS
Our results suggest that the cognitive profile can be considered as an endophenotype of psychotic disorders.",2020,Our results revealed attenuation of abstract thinking in the siblings compared to the controls.,"['patients with schizophrenia and their relatives searching for endophenotypes of the disease', 'Four groups of subjects were included: patients with a first episode of psychotic illness, the siblings of these patients, and two control groups', 'siblings of the patients', 'healthy siblings of first-episode schizophrenia patients']",[],"['battery of neuropsychological tests that measured basic cognitive domains - memory, executive functions, attention, visual-spatial skills, language skills and psychomotor speed - administered to them', 'abstract thinking', 'cognitive performance and cognitive subtypes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]",84.0,0.0176113,Our results revealed attenuation of abstract thinking in the siblings compared to the controls.,"[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Voráčková', 'Affiliation': 'Applied Neurosciences and Brain Imaging, National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Knytl', 'Affiliation': 'Diagnostics and Treatment of Mental Disorders, National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Španiel', 'Affiliation': 'Applied Neurosciences and Brain Imaging, National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Šustová', 'Affiliation': 'Applied Neurosciences and Brain Imaging, National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Renka', 'Affiliation': 'Diagnostics and Treatment of Mental Disorders, National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Diagnostics and Treatment of Mental Disorders, National Institute of Mental Health, Klecany, Czech Republic.'}]",Early intervention in psychiatry,['10.1111/eip.12982']
3498,32488988,"Authors' reply re: Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).",,2020,,['women having repeat anterior or posterior prolapse surgery'],['mesh kit or native tissue repair'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.201418,,"[{'ForeName': 'Cathryn Ma', 'Initials': 'CM', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Aucott', 'Affiliation': 'University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Reid', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16302']
3499,32488989,Phase 1 Study to Evaluate the Effect of the Investigational Anticancer Agent Sapanisertib on the QTc Interval in Patients With Advanced Solid Tumors.,"The aim of this phase 1 study was to determine the effects of sapanisertib on the heart rate-corrected QT (QTc) interval in patients with advanced solid tumors. Adult patients with advanced solid tumors were enrolled to receive a single sapanisertib 40-mg dose. Blood samples for pharmacokinetic analysis were collected and electrocardiogram readings were recorded at baseline and up to 48 hours after dosing. Patients could continue to receive sapanisertib 30 mg once weekly in 28-day cycles for up to 12 months. The primary objective was to characterize the effect of a single dose of sapanisertib (40 mg) on the QT interval. Secondary objectives were to evaluate safety, tolerability, and pharmacokinetics. Following a single sapanisertib 40-mg dose in 44 patients, the maximum least squares mean (upper bound of 1-sided 95% confidence interval) changes from time-matched baseline were 7.1 milliseconds (11.4 milliseconds) for individual rate-corrected QT interval at 24 hours after dosing, and 1.8 milliseconds (5.6 milliseconds) for Fridericia-corrected QTc at 1 hour post-dose. There was no sapanisertib plasma concentration-dependent increase in the change from time-matched baseline individual rate-corrected QTc interval or Fridericia-corrected QTc. The most common adverse events following sapanisertib 30 mg once-weekly dosing were nausea (80%), fatigue (61%), vomiting (57%), and decreased appetite (45%). A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors. The safety profile of sapanisertib 30 mg once weekly was favorable, and no new safety signals were observed (NCT02197572, clinicaltrials.gov).",2020,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"['Adult patients with advanced solid tumors', 'Patients With Advanced Solid Tumors', 'patients with advanced solid tumors']",['sapanisertib'],"['QTc interval', 'fatigue', 'safety, tolerability, and pharmacokinetics', 'sapanisertib plasma concentration', 'appetite', 'vomiting', 'nausea', 'heart rate-corrected QT (QTc) interval']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]",[],"[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.278022,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"[{'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Patel', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Montefiore Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Rangachari', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jayson D', 'Initials': 'JD', 'LastName': 'Wilbur', 'Affiliation': 'Metrum Research Group, LCC, Connecticut, USA.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Shou', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'A Craig', 'Initials': 'AC', 'LastName': 'Lockhart', 'Affiliation': 'Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.808']
3500,32489206,"Evaluation of magnesium as an adjuvant to ropivacaine-induced axillary brachial plexus block: A prospective, randomised, double-blind study.","Background and Aims
Axillary brachial plexus block is commonly performed for surgeries on the hand and forearm. However, there are very few studies on the use of magnesium sulphate in axillary brachial plexus block and, hence, the study was designed to evaluate magnesium as an adjuvant to ropivacaine-induced axillary block with respect to onset and duration of sensorimotor block and postoperative analgesia.
Methods
Sixty patients of the American Society of Anesthesiologists (ASA) physical status I and II, undergoing surgeries on the hand and forearm were randomly recruited to receive ultrasound-guided axillary block with either 150 mg magnesium sulphate or 1 mL normal saline added to 0.5% ropivacaine. The primary outcome measure was to compare block characteristics including postoperative analgesia and the secondary outcome was to compare the use of rescue analgesia and the side-effect profile. Data were statistically analysed using Statistical Package for Social Sciences (SPSS version 21.0). Categorical variables were compared using the Chi-square test or Fisher's exact probability test; continuous variables compared using unpaired t -test or Mann-Whitney U test.
Results
Onset of sensory (9.93 ± 1.31 vs 8.83 ± 1.12 min) as well as motor block (13.37 ± 1.63 vs 11.57 ± 1.30 min) was significantly hastened with addition of magnesium to ropivacaine ( p < 0.001) and so was the duration (sensory 386.60 ± 18.26 vs 526.37 ± 27.43, motor 323.73 ± 15.17 vs 436.97 ± 18.99 min) ( p < 0.001) and postoperative analgesia (425 ± 21.39 vs 572.83 ± 32.04 min) ( p < 0.001) which reflected in decreased requirement of rescue analgesic and total postoperative analgesic dosage.
Conclusions
Magnesium is an effective and safe adjuvant to local anaesthetics and improves all characteristics of axillary brachial plexus block along with postoperative analgesia.",2020,"p < 0.001) and postoperative analgesia (425 ± 21.39 vs 572.83 ± 32.04 min) ( p < 0.001) which reflected in decreased requirement of rescue analgesic and total postoperative analgesic dosage.
","['induced axillary brachial plexus block', 'Sixty patients of the American Society of Anesthesiologists (ASA) physical status I and II, undergoing surgeries on the hand and forearm']","['Magnesium', 'ropivacaine', 'ultrasound-guided axillary block with either 150 mg magnesium sulphate or 1 mL normal saline added to 0.5% ropivacaine', 'magnesium sulphate', 'magnesium']","['block characteristics including postoperative analgesia', 'rescue analgesic and total postoperative analgesic dosage', 'motor block', 'postoperative analgesia', 'rescue analgesia and the side-effect profile']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0394701', 'cui_str': 'Brachial plexus block by axillary approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0474702', 'cui_str': 'Sulfate measurement'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.321685,"p < 0.001) and postoperative analgesia (425 ± 21.39 vs 572.83 ± 32.04 min) ( p < 0.001) which reflected in decreased requirement of rescue analgesic and total postoperative analgesic dosage.
","[{'ForeName': 'Jyoti P', 'Initials': 'JP', 'LastName': 'Deshpande', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Shrimati Kashibai Navale Medical College and General Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Kalyani N', 'Initials': 'KN', 'LastName': 'Patil', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Shrimati Kashibai Navale Medical College and General Hospital, Pune, Maharashtra, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_833_19']
3501,32489207,Comparison of perioperative patient comfort with 'enhanced recovery after surgery (ERAS) approach' versus 'traditional approach' for elective laparoscopic cholecystectomy.,"Background
Perioperative anxiety, hunger, thirst, fatigue, pain along with nausea and vomiting can influence a patient's recovery after surgery. We aimed to compare 'enhanced recovery after surgery' (ERAS) protocol with a traditional perioperative approach to evaluate a patient's recovery after elective laparoscopic cholecystectomy.
Methods
A prospective randomised controlled study was conducted after institutional ethical clearance on 50 patients undergoing elective laparoscopic cholecystectomy, and divided equally into two groups. In group 1 (traditional); standard fasting guidelines and routine perioperative management was implemented. In group 2 (ERAS); patients received appropriate multimedia information about surgery and anaesthesia besidecarbohydrate loading with tender coconut water on the previous night and on the morning of surgery. Standard guidelines of fasting for solids were followed. Intraoperatively, goal-directed fluid therapy and an inspired oxygen concentration of 60% were administered. Postoperatively, early diet and mobilisation were initiated. The primary outcome was the assessment of perioperative anxiety. Hunger, thirst, fatigue, pain, nausea, vomiting and overall perioperative experience were also evaluated.
Results
ERAS group had reduced anxiety prior to surgery: median (interquartile range) 3 (3-4) vs 2 (2-3) ( P = 0.003), and at 6 h postoperatively: 4 (3-6) vs 3 (1-4) ( P = 0.001). Hunger, thirst and fatigue ( P < 0.01) were also decreased with better overall perioperative experience (5 [4-5] vs 6 [5-7], P = 0.004). Pain, nausea, vomiting and blood glucose were similar between the groups.
Conclusion
'ERAS approach reduces anxiety in addition to hunger, thirst and fatigue with enhanced overall perioperative comfort in patients undergoing laparoscopic cholecystectomy.",2020,"Hunger, thirst and fatigue ( P < 0.01) were also decreased with better overall perioperative experience (5 [4-5] vs 6 [5-7], P = 0.004).","['50 patients undergoing elective laparoscopic cholecystectomy, and divided equally into two groups', 'elective laparoscopic cholecystectomy', ""patient's recovery after elective laparoscopic cholecystectomy"", 'patients undergoing laparoscopic cholecystectomy']","['appropriate multimedia information about surgery and anaesthesia besidecarbohydrate loading with tender coconut water on the previous night and on the morning of surgery', ""perioperative patient comfort with 'enhanced recovery after surgery (ERAS) approach"", 'ERAS']","['Hunger, thirst and fatigue', '\n\n\nPerioperative anxiety, hunger, thirst, fatigue, pain along with nausea and vomiting', 'assessment of perioperative anxiety', 'Pain, nausea, vomiting and blood glucose', 'overall perioperative experience', 'reduced anxiety', 'Hunger, thirst, fatigue, pain, nausea, vomiting and overall perioperative experience']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C4271504', 'cui_str': 'coconut water'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}]",50.0,0.0535379,"Hunger, thirst and fatigue ( P < 0.01) were also decreased with better overall perioperative experience (5 [4-5] vs 6 [5-7], P = 0.004).","[{'ForeName': 'Madhumita', 'Initials': 'M', 'LastName': 'Udayasankar', 'Affiliation': 'Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Udupi', 'Affiliation': 'Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Shenoy', 'Affiliation': 'Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_782_19']
3502,32489236,"Responsiveness of pain, functional capacity tests, and disability level in individuals with chronic nonspecific low back pain.","Background
Clinical outcomes are very important in clinical assessment, and responsiveness is a component inside the outcome measures that needs to be investigated, particularly in chronic nonspecific low back pain (CNSLBP).
Objective
This study aimed to investigate the responsiveness of pain, functional capacity tests, and disability in individuals with CNSLBP.
Methods
Twenty subjects were assessed in pain using the following methods: visual analog scale (VAS) and numeric pain rating scale (NPRS), functional capacity tests: functional reach test (FRT), five-time sit-to-stand test (5 TSST), and two-minute step test (2 MST), and disability level: modified Oswestry Disability Questionnaire (MODQ), Thai version before and after 2-week intervention session. For interventions, the subjects received education, spinal manipulative therapy, and individual therapeutic exercise twice a week, for a total of two weeks. The statistics analyzed were change scores, effect size (ES), and standardized response mean (SRM).
Results
The most responsive parameter for individuals with CNSLBP was pain as measured by numeric pain rating scale (NPRS) (ES -0.986, SRM -0.928) and five-time sit-to-stand test (5 TSST) (SRM -0.846).
Conclusion
This study found that NPRS pain and 5 TSST were responsive in individuals with CNSLBP at two weeks after the beginning of interventions.",2020,"The most responsive parameter for individuals with CNSLBP was pain as measured by numeric pain rating scale (NPRS) (ES -0.986, SRM -0.928) and five-time sit-to-stand test (5 TSST) (","['individuals with CNSLBP', 'individuals with chronic nonspecific low back pain']","['education, spinal manipulative therapy, and individual therapeutic exercise']","['Responsiveness of pain, functional capacity tests, and disability level', 'pain, functional capacity tests, and disability', 'change scores, effect size (ES), and standardized response mean (SRM', 'numeric pain rating scale (NPRS', 'visual analog scale (VAS) and numeric pain rating scale (NPRS), functional capacity tests: functional reach test (FRT), five-time sit-to-stand test (5 TSST), and two-minute step test (2 MST), and disability level: modified Oswestry Disability Questionnaire (MODQ), Thai version']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1834582', 'cui_str': 'Transient abnormal myelopoiesis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",20.0,0.0519588,"The most responsive parameter for individuals with CNSLBP was pain as measured by numeric pain rating scale (NPRS) (ES -0.986, SRM -0.928) and five-time sit-to-stand test (5 TSST) (","[{'ForeName': 'Prasert', 'Initials': 'P', 'LastName': 'Sakulsriprasert', 'Affiliation': 'Division of Physical Therapy, Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, 73170, Thailand.'}, {'ForeName': 'Roongtiwa', 'Initials': 'R', 'LastName': 'Vachalathiti', 'Affiliation': 'Division of Physical Therapy, Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, 73170, Thailand.'}, {'ForeName': 'Pathaimas', 'Initials': 'P', 'LastName': 'Kingcha', 'Affiliation': 'Physical Therapy Center, Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, 73170, Thailand.'}]",Hong Kong physiotherapy journal : official publication of the Hong Kong Physiotherapy Association Limited = Wu li chih liao,['10.1142/S101370252050002X']
3503,32489237,Thai dance exercises benefited functional mobility and fall rates among community-dwelling older individuals.,"Background
With dramatic increase in the number of older individuals, special efforts have been made to promote the levels of independence and reduce fall rates among these individuals.
Objective
To investigate the effects of Thai dance exercises over 6 weeks on functional mobility and fall rates in community-dwelling older individuals.
Methods
Sixty-one community-dwelling older adults were interviewed and assessed for their demographics and fall data during 6 months prior to participation in the study. Then they completed the quasi-experimental Thai dance exercise program for 50 minutes/day, 3 days/week over 6 weeks. Their functional mobility relating to levels of independence and safety were assessed prior to training, at 3-week and 6-week training. After completing the program at 6 weeks, participants were prospectively monitored for fall data over 6 months.
Results
Participants improved their functional mobility significantly after 3- and 6-week training ( p < 0.01 ) . The number of faller individuals obviously decreased from 35% ( n = 21 ) prior to training to only 8% ( n = 5 ) after training ( p < 0.01 ) .
Conclusion
The current findings further extend benefits of Thai dance as an alternative musical exercise program to promote levels of independence and safety among community-dwelling older adults.",2020,"The number of faller individuals obviously decreased from 35% ( n = 21 ) prior to training to only 8% ( n = 5 ) after training ( p < 0.01 ) .
","['community-dwelling older individuals', 'community-dwelling older adults', 'Methods\n\n\nSixty-one community-dwelling older adults']","['musical exercise program', 'Thai dance exercises']","['functional mobility', 'number of faller individuals obviously', 'functional mobility and fall rates']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0010963', 'cui_str': 'Dance'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",61.0,0.0109918,"The number of faller individuals obviously decreased from 35% ( n = 21 ) prior to training to only 8% ( n = 5 ) after training ( p < 0.01 ) .
","[{'ForeName': 'Chonticha', 'Initials': 'C', 'LastName': 'Kaewjoho', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Lugkana', 'Initials': 'L', 'LastName': 'Mato', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thiwabhorn', 'Initials': 'T', 'LastName': 'Thaweewannakij', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Saowanee', 'Initials': 'S', 'LastName': 'Nakmareong', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Supaporn', 'Initials': 'S', 'LastName': 'Phadungkit', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Chitanongk', 'Initials': 'C', 'LastName': 'Gaogasigam', 'Affiliation': 'Improvement of Physical Performance and Quality of Life (IPQ), Research Group, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sugalya', 'Initials': 'S', 'LastName': 'Amatachaya', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}]",Hong Kong physiotherapy journal : official publication of the Hong Kong Physiotherapy Association Limited = Wu li chih liao,['10.1142/S1013702520500031']
3504,32484914,A randomized phase 3 study of maintenance therapy with S-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus S-1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L).,"BACKGROUND
A randomized phase 3 study was performed to investigate the efficacy and safety of maintenance therapy with S-1 after induction therapy with carboplatin plus S-1 in patients with advanced squamous non-small cell lung cancer (NSCLC).
METHODS
Chemotherapy-naive patients with advanced or relapsed squamous NSCLC were treated with carboplatin (area under the curve of 5 on day 1 every 3 weeks) plus S-1 (40 mg/m 2 twice per day on days 1-14 every 3 weeks) as induction therapy. Patients who did not progress after 4 cycles of induction therapy were randomized to receive either S-1 plus best supportive care (BSC) or BSC alone. The primary objective of the study was to confirm the superiority of S-1 plus BSC in comparison with BSC alone with respect to progression-free survival.
RESULTS
Of the 365 patients enrolled in the study, 347 participated in the induction phase, and 131 of these individuals were randomized to receive S-1 plus BSC (n = 67) or BSC alone (n = 64). The risk of disease progression was significantly lower for patients in the S-1 plus BSC arm than those in the BSC-alone arm (hazard ratio, 0.548; 95% confidence interval, 0.374-0.802; P = .0019). The most common toxicities during maintenance therapy with S-1 included anorexia, anemia, and fatigue, but most cases were not severe.
CONCLUSIONS
Continued maintenance with S-1 plus BSC is an effective and well-tolerated treatment option for patients with advanced squamous NSCLC previously treated with carboplatin plus S-1.",2020,"The risk of disease progression was significantly lower for patients in the S-1 plus BSC arm than those in the BSC-alone arm (hazard ratio, 0.548; 95% confidence interval, 0.374-0.802; P = .0019).","['for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L', 'Chemotherapy-naive patients with advanced or relapsed squamous NSCLC', 'patients with advanced squamous NSCLC previously treated with', '365 patients enrolled in the study', 'patients with advanced squamous non-small cell lung cancer (NSCLC', '347 participated in the induction phase, and 131 of these individuals', 'Patients who did not progress after 4 cycles of induction therapy']","['BSC alone', 'S-1 plus best supportive care (BSC) or BSC alone', 'carboplatin (area under the curve of 5 on day 1 every 3\xa0weeks) plus S-1', 'S-1 plus BSC', 'carboplatin plus S-1']","['efficacy and safety', 'risk of disease progression', 'anorexia, anemia, and fatigue']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0149782', 'cui_str': 'Squamous cell carcinoma of lung'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",365.0,0.0908591,"The risk of disease progression was significantly lower for patients in the S-1 plus BSC arm than those in the BSC-alone arm (hazard ratio, 0.548; 95% confidence interval, 0.374-0.802; P = .0019).","[{'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Data Coordinating Center, Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Respiratory Medicine, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ishiguro', 'Affiliation': 'Division of Respiratory Medicine and Oncology, Gifu Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Miura', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Toyozawa', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Oguri', 'Affiliation': 'Department of Education and Research Center for Community Medicine, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Ko', 'Affiliation': 'Department of Respiratory Medicine, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Bessho', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Respiratory Medicine, Hiroshima City Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Hirano', 'Affiliation': 'Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakanishi', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}]",Cancer,['10.1002/cncr.32987']
3505,32484940,Therapeutic index of inhaled corticosteroids in asthma: a dose-response comparison on airway hyperresponsiveness and adrenal axis suppression.,"AIM
To compare the airway potency, systemic activity and therapeutic index of three inhaled corticosteroids (ICS) that differ in glucocorticoid receptor binding affinity, physicochemical and pharmacokinetic properties.
METHODS
This escalating-dose, placebo-controlled, cross-over study randomised adults with asthma to one or two treatment periods with ≥25-days' washout in-between. Each treatment period comprised five 7-day dose-escalations (μg/day): fluticasone furoate (FF; 25→100→200→400→800), fluticasone propionate (FP; 50→200→500→1000→2000), budesonide (BUD; 100→400→800→1600→3200) or placebo. Airway hyperresponsiveness to adenosine-5'-monophosphate (AMP PC 20 ) was assessed on day 8. Plasma cortisol was assessed on day 1 (pre-dose baseline) and from pre-PM dose on day 6 to pre-PM dose day 7 (24-hour weighted mean).
RESULTS
Fifty-four subjects were randomised. FF showed greater airway potency than FP and BUD (AMP PC 20 ED 50 values: 48.52, 1081.27 and 1467.36μg/day, respectively). Systemic activity (cortisol suppression) ED 50 values were 899.99, 1986.05 and 1927.42μg/day, respectively. The therapeutic index (ED 50 cortisol suppression/ED 50 AMP PC 20 ) was wider for FF (18.55) than FP (1.84) and BUD (1.31). FF 100μg/day and 200μg/day were both comparable in terms of airway potency with high doses of FP (≥1000μg twice daily [BID]) and BUD (≥1500μg/BID). The systemic activity of FF 100μg/day and 200μg/day (cortisol suppression: 7.41% and 14.28%, respectively) was comparable with low doses of FP (100μg/BID and 250μg/BID) and BUD (100μg/BID and 200μg/BID).
CONCLUSION
This study provides evidence that FF can provide more protection against airway hyperresponsiveness, with less systemic activity, than FP or BUD. This suggests that all ICS are not therapeutically similar and may differ in their therapeutic index. (203162; NCT02991859).",2020,"FF showed greater airway potency than FP and BUD (AMP PC 20 ED 50 values: 48.52, 1081.27 and 1467.36μg/day, respectively).","['asthma', 'Fifty-four subjects were randomised', ""adults with asthma to one or two treatment periods with ≥25-days' washout in-between""]","['FF', 'fluticasone propionate', 'corticosteroids (ICS', 'FP', 'budesonide', 'inhaled corticosteroids', 'fluticasone furoate', 'placebo']","['systemic activity', 'Plasma cortisol', 'airway potency', 'Systemic activity (cortisol suppression', 'airway potency, systemic activity and therapeutic index']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}]",54.0,0.207423,"FF showed greater airway potency than FP and BUD (AMP PC 20 ED 50 values: 48.52, 1081.27 and 1467.36μg/day, respectively).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Daley-Yates', 'Affiliation': 'Clinical Pharmacology and Experimental Medicine, GlaxoSmithKline plc., Uxbridge, UK.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Brealey', 'Affiliation': 'Clinical Pharmacology and Experimental Medicine, GlaxoSmithKline plc., Uxbridge, UK.'}, {'ForeName': 'Sebin', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Biostatistics and Programming, GlaxoSmithKline plc., Bangalore, India.'}, {'ForeName': 'Daren', 'Initials': 'D', 'LastName': 'Austin', 'Affiliation': 'Clinical Pharmacology and Experimental Medicine, GlaxoSmithKline plc., Uxbridge, UK.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Shabbir', 'Affiliation': 'Medicines Research Centre, GlaxoSmithKline plc., Stevenage, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Respiratory Research Unit, Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barnes', 'Affiliation': 'Global Medical Franchise, GlaxoSmithKline plc., Brentford, UK.'}]",British journal of clinical pharmacology,['10.1111/bcp.14406']
3506,32484952,Implicit play or explicit cognitive behaviour therapy: The impact of intervention approaches to facilitate social skills development in adolescents.,"INTRODUCTION
Early adolescence is a time of increased social interaction with peers. Social competence is related to pretend play ability in younger children, but a lack of pretend play ability in childhood may also be associated with social challenges in early adolescence. Adolescents who find social situations challenging experience alienation from peers resulting in lowered self-regard. This paper presents an exploratory study comparing an Implicit group intervention (age-appropriate play based group (PB)) to an Explicit group intervention Cognitive Behavioural Therapy (CBT) to increase social ability in adolescents.
METHODS
Six adolescents, three female and three male, were in the Implicit group (PB; mean age 12.3 years, SD = 1.21). Six male adolescents were in the Explicit group (CBT; mean age 13.3 years, SD = 1.03). All participants were assessed pre- and post the 8-week intervention for social competence, cognitive flexibility and narrative ability. The Implicit group (PB) was assessed through an age appropriate play assessment. Seven participants had a formal diagnosis, including autism spectrum disorder, and all were in mainstream high schools.
RESULTS
The Explicit group (CBT) showed a medium effect for social engagement, total social skills, emotional engagement and a large effect for a decrease in flexible thinking. The Implicit group (PB) showed a large impact for narrative ability with increases in ability to sequence events, initiation and creation of plot, understanding character roles and total movie score, with medium effects for generation of problems, precise vocabulary and use of symbols. The Implicit group (PB) maintained cognitive flexibility, and decreased in social self-scoring which showed medium effects for externalising and internalising.
CONCLUSION
This paper contributes to evidence that the choice of social skills intervention impacts different skill sets. For neuro-diverse adolescents, the cognitive intervention impacted social and emotional engagement and the play-based intervention impacted a wider range of abilities related to narrative social interaction.",2020,"The Explicit group (CBT) showed a medium effect for social engagement, total social skills, emotional engagement and a large effect for a decrease in flexible thinking.","['Six adolescents, three female and three male, were in the Implicit group (PB; mean age 12.3\xa0years, SD\xa0=\xa01.21', 'younger children', 'Seven participants had a formal diagnosis, including autism spectrum disorder, and all were in mainstream high schools', 'adolescents', 'Six male adolescents']","['Implicit group intervention (age-appropriate play based group (PB)) to an Explicit group intervention Cognitive Behavioural Therapy (CBT', 'Implicit play or explicit cognitive behaviour therapy']","['ability to sequence events, initiation and creation of plot, understanding character roles and total movie score, with medium effects for generation of problems, precise vocabulary and use of symbols', 'social competence, cognitive flexibility and narrative ability', 'flexible thinking', 'social engagement, total social skills, emotional engagement']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",6.0,0.0174906,"The Explicit group (CBT) showed a medium effect for social engagement, total social skills, emotional engagement and a large effect for a decrease in flexible thinking.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Goldingay', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Stagnitti', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Robertson', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Pepin', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Sheppard', 'Affiliation': 'School of Allied Health, Australian Catholic University, Melbourne, Vic., Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Dean', 'Affiliation': 'School of Nursing and Midwifery, Deakin University, Geelong, Vic., Australia.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12673']
3507,32485095,"Differential Effects of Testosterone on Peripheral Neutrophils, Monocytes and Platelets in Men: Findings from Two Trials.","BACKGROUND
Testosterone treatment increases erythrocytes in men, but its effects on leukocyte and platelet counts are unknown and could affect its safety.
OBJECTIVE
To determine if testosterone affects circulating leukocytes and platelets in men.
METHODS
Secondary analyses of two randomized testosterone trials were performed: the 5α-Reductase (5aR) and OPTIMEN Trials. In 5aR trial, 102 healthy men, 21-50 years (mean age 38), received a long-acting GnRH-agonist, and 50, 125, 300, or 600 mg * week -1 testosterone enanthate (TE) plus placebo or 2.5 mg * day -1 dutasteride for 20-weeks. In OPTIMEN, 78 functionally-limited men, ≥65 years (mean age 72) with protein intake ≤0.83 g * kg -1 * day -1 were randomized to controlled diets with 0.8 g * kg -1 * day -1 protein or 1.3 g * kg -1 * day -1 protein plus placebo or TE (100 mg * week -1 ) for 6 months. Changes from baseline in total and differential leukocyte count, and platelet count were evaluated.
RESULTS
In 5aR, testosterone administration was associated with increases in total leukocyte (estimated change from baseline 40, 490, 1230, and 1280 cells/µL, p<0.001), neutrophil (65.1, 436.1, 1177.2, and 1192.2 cells/µL, p<0.001), monocyte (-20.2, 24.5, 90.6, and 143.9 cells/µL, p<0.001), platelet (-7.3, 8.4, 8.7 and 8.9 * 10 3 cells/µL, p=0.033), and erythrocyte counts. Testosterone did not affect absolute lymphocyte count. Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77 * 10 3 cells/µL, P vs placebo=0.004).
CONCLUSIONS
Testosterone administration in men differentially increases neutrophil and monocyte counts. These findings, together with its erythropoietic effects, suggest that testosterone promotes the differentiation of hematopoietic progenitors into the myeloid lineage. These findings have potential mechanistic, therapeutic and safety implications.",2020,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"['78 functionally-limited men, ≥65 years (mean age 72) with protein intake ≤0.83 g * kg -1 * day -1', 'men', '102 healthy men, 21-50 years (mean age 38', 'Men']","['controlled diets with 0.8 g * kg -1 * day -1 protein or 1.3 g * kg -1 * day -1 protein plus placebo or TE', 'testosterone', 'Testosterone', 'enanthate (TE) plus placebo', '5α-Reductase (5aR']","['total and differential leukocyte count, and platelet count', 'monocyte', 'total leukocyte', 'total leukocyte count', 'Peripheral Neutrophils, Monocytes and Platelets', 'platelet', 'neutrophil and monocyte counts', 'absolute lymphocyte count', 'neutrophil', 'erythrocyte counts']","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0019226', 'cui_str': 'Enanthates'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162401', 'cui_str': 'Differential white blood cell count procedure'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",102.0,0.505029,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Gagliano-Jucá', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Karol M', 'Initials': 'KM', 'LastName': 'Pencina', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Zhuoying', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}]",Andrology,['10.1111/andr.12834']
3508,32485112,"Effect of Platelet-Rich Plasma on Nonsurgically Treated Acute Achilles Tendon Ruptures: A Randomized, Double-Blinded Prospective Study.","BACKGROUND
An acute Achilles tendon rupture (ATR) is a long-lasting and devastating injury. Possible biological augmentation to promote and strengthen tendon healing after an ATR would be desirable.
PURPOSE
To determine whether the application of a platelet-rich plasma (PRP) injection in nonsurgically treated ATRs may promote healing and thereby improve functional outcomes.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 2.
METHODS
A total of 40 men (aged 18-60 years) with an ATR incurred within 72 hours were included, and 38 were followed for 12 months. All patients were treated with an orthosis with 3 wedges for 8 weeks; full weightbearing from day 1 was allowed, combined with either 4 PRP or 4 placebo injections (a few drops of saline, <0.5 mL, under the skin) 14 days apart. All patients received the same instructions on an exercise program starting from week 9. Outcomes included the self-reported Achilles tendon Total Rupture Score (ATRS) as well as heel-rise work, heel-rise height, tendon elongation, calf circumference, and ankle dorsiflexion range of motion.
RESULTS
The mean ATRS score improved in both groups at all time points ( P < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group). No differences in all functional outcomes at any time points were seen between the groups. At 12 months, the injured leg did not reach normal functional values compared with the uninjured leg.
CONCLUSION
The application of PRP in nonsurgically treated ATRs did not appear to show any superior clinical and functional improvement.
REGISTRATION
NCT02417922 (ClinicalTrials.gov identifier).",2020,"The mean ATRS score improved in both groups at all time points ( P < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group).","['40 men (aged 18-60 years) with an ATR incurred within 72 hours were included, and 38 were followed for 12 months', 'Nonsurgically Treated Acute Achilles Tendon Ruptures']","['PRP or 4 placebo injections (a few drops of saline, <0.5 mL, under the skin', 'Platelet-Rich Plasma', 'platelet-rich plasma (PRP) injection']","['self-reported Achilles tendon Total Rupture Score (ATRS) as well as heel-rise work, heel-rise height, tendon elongation, calf circumference, and ankle dorsiflexion range of motion', 'mean ATRS score']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",72.0,0.431477,"The mean ATRS score improved in both groups at all time points ( P < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group).","[{'ForeName': 'Anders Ploug', 'Initials': 'AP', 'LastName': 'Boesen', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten Ilum', 'Initials': 'MI', 'LastName': 'Boesen', 'Affiliation': 'Department Of Orthopaedics, Køge Sygehus, Køge, Denmark.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Hansen', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Department of Orthopaedic Surgery, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lenskjold', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'CopenRehab, Section of Social Medicine, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The American journal of sports medicine,['10.1177/0363546520922541']
3509,32485124,"Effects of a single dose of vitamin D in septic children: a randomized, double-blinded, controlled trial.","OBJECTIVE
To assess the effects of a single dose of vitamin D on 25-hydroxyvitamin D (25OHD) levels and clinical outcomes in children with vitamin D deficiency (VDD) and sepsis.
METHODS
In this randomized, controlled trial, eligible children with VDD and sepsis were assigned to receive one dose of 150,000 IU of cholecalciferol or placebo. Serum concentrations of 25OHD, angiotensin-II (Ang-II), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were assessed at baseline and 8 days after treatment. The cardiovascular Sequential Organ Failure Assessment (cv-SOFA) score, septic shock incidence, duration of ventilation, and mortality were also examined.
RESULTS
One hundred nine participants fulfilled the study requirements. The two groups had comparable baseline characteristics. Ang-II, IL-6, and TNF-α concentrations were all reduced after vitamin D supplementation. Furthermore, the cv-SOFA score (1.76 ± 0.8 vs. 2.3 ± 1.1) and incidence of septic shock (7% vs. 20%) were lower in the treatment group than in the control group. The duration of ventilation and mortality rates did not differ between two groups.
CONCLUSIONS
A single dose of vitamin D improved 25OHD levels and the incidence of septic shock in children with VDD and sepsis.",2020,A single dose of vitamin D improved 25OHD levels and the incidence of septic shock in children with VDD and sepsis.,"['children with VDD and sepsis', 'eligible children with VDD and sepsis', 'septic children', 'children with vitamin D deficiency (VDD) and sepsis', 'One hundred nine participants fulfilled the study requirements']","['cholecalciferol or placebo', 'vitamin D']","['incidence of septic shock', 'Ang-II, IL-6, and TNF-α concentrations', 'duration of ventilation and mortality rates', '25OHD levels', 'Serum concentrations of 25OHD, angiotensin-II (Ang-II), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α', '25-hydroxyvitamin D (25OHD) levels and clinical outcomes', 'cardiovascular Sequential Organ Failure Assessment (cv-SOFA) score, septic shock incidence, duration of ventilation, and mortality', 'cv-SOFA score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}]",,0.753691,A single dose of vitamin D improved 25OHD levels and the incidence of septic shock in children with VDD and sepsis.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}, {'ForeName': 'Zhongwen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}, {'ForeName': 'Zhenfeng', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}, {'ForeName': 'Qianhan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatrics, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan, China.""}]",The Journal of international medical research,['10.1177/0300060520926890']
3510,32488524,Organizational factors associated with adherence to low tidal volume ventilation: a secondary analysis of the CHECKLIST-ICU database.,"BACKGROUND
Survival benefit from low tidal volume (V T ) ventilation (LTVV) has been demonstrated for patients with acute respiratory distress syndrome (ARDS), and patients not having ARDS could also benefit from this strategy. Organizational factors may play a role on adherence to LTVV. The present study aimed to identify organizational factors with an independent association with adherence to LTVV.
METHODS
Secondary analysis of the database of a multicenter two-phase study (prospective cohort followed by a cluster-randomized trial) performed in 118 Brazilian intensive care units. Patients under mechanical ventilation at day 2 were included. LTVV was defined as a V T ≤ 8 ml/kg PBW on the second day of ventilation. Data on the type and number of beds of the hospital, teaching status, nursing, respiratory therapists and physician staffing, use of structured checklist, and presence of protocols were tested. A multivariable mixed-effect model was used to assess the association between organizational factors and adherence to LTVV.
RESULTS
The study included 5719 patients; 3340 (58%) patients received LTVV. A greater number of hospital beds (absolute difference 7.43% [95% confidence interval 0.61-14.24%]; p = 0.038), use of structured checklist during multidisciplinary rounds (5.10% [0.55-9.81%]; p = 0.030), and presence of at least one nurse per 10 patients during all shifts (17.24% [0.85-33.60%]; p = 0.045) were the only three factors that had an independent association with adherence to LTVV.
CONCLUSIONS
Number of hospital beds, use of a structured checklist during multidisciplinary rounds, and nurse staffing are organizational factors associated with adherence to LTVV. These findings shed light on organizational factors that may improve ventilation in critically ill patients.",2020,"A greater number of hospital beds (absolute difference 7.43% [95% confidence interval 0.61-14.24%]; p = 0.038), use of structured checklist during multidisciplinary rounds (5.10% [0.55-9.81%]; p = 0.030), and presence of at least one nurse per 10 patients during all shifts (17.24% [0.85-33.60%]; p = 0.045) were the only three factors that had an independent association with adherence to LTVV.
","['5719 patients; 3340 (58%) patients received', 'Patients under mechanical ventilation at day 2 were included', 'critically ill patients', 'Secondary analysis of the database of a multicenter two-phase study (prospective cohort followed by a cluster-randomized trial) performed in 118 Brazilian intensive care units', 'patients with acute respiratory distress syndrome (ARDS']","['LTVV', 'low tidal volume (V T ) ventilation (LTVV']",['number of hospital beds'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0336603', 'cui_str': 'Hospital bed'}]",5719.0,0.069342,"A greater number of hospital beds (absolute difference 7.43% [95% confidence interval 0.61-14.24%]; p = 0.038), use of structured checklist during multidisciplinary rounds (5.10% [0.55-9.81%]; p = 0.030), and presence of at least one nurse per 10 patients during all shifts (17.24% [0.85-33.60%]; p = 0.045) were the only three factors that had an independent association with adherence to LTVV.
","[{'ForeName': 'Thais Dias', 'Initials': 'TD', 'LastName': 'Midega', 'Affiliation': 'Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Albert Einstein Avenue, 700, São Paulo, Brazil.'}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Bozza', 'Affiliation': ""Research Institute, Instituto D'Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Anesthesiology, Pain and Intensive Care Department, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Helio Penna', 'Initials': 'HP', 'LastName': 'Guimarães', 'Affiliation': 'Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Albert Einstein Avenue, 700, São Paulo, Brazil.'}, {'ForeName': 'Jorge I', 'Initials': 'JI', 'LastName': 'Salluh', 'Affiliation': ""Graduate Program in Translational Medicine and Department of Critical Care, Instituto D'Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Antonio Paulo', 'Initials': 'AP', 'LastName': 'Nassar', 'Affiliation': 'Intensive Care Unit and Postgraduate Program, A.C. Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Normílio-Silva', 'Affiliation': 'Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Albert Einstein Avenue, 700, São Paulo, Brazil. ary.neto2@einstein.br.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of intensive care,['10.1186/s13613-020-00687-3']
3511,32488654,Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL.,"BACKGROUND
Endobiliary radiofrequency ablation (EB-RFA) has emerged as a palliative treatment for malignant biliary strictures (MBSs); however, concerns about complications related to thermal injury remain. In this study, we evaluated the efficacy and safety of EB-RFA with a novel catheter for MBS.
METHODS
Patients with inoperable cancer causing MBS were randomly assigned to either the radiofrequency ablation (RFA) group or the non-RFA group. The RFA group underwent EB-RFA at the stricture site with a temperature-controlled catheter (ELRA™; STARmed Co., Goyang, Korea) followed by deployment of a self-expanding metal stent (SEMS). For the non-RFA group, only SEMS placement was performed. The duration of stent patency, overall survival (OS), and 30-day complication rate were evaluated. This trial was registered at ClinicalTrials.gov (number NCT02646514).
RESULTS
A total of 48 patients were enrolled (24 in each group). During a median follow-up period of 135.0 days (RFA group) and 119.5 days (non-RFA group), the 90-day stent patency rate, median duration of stent patency, and median OS were not different between the groups (58.3% vs. 45.8% [P = 0.386], 132.0 days vs. 116.0 days [P = 0.440], and 244.0 days vs. 180.0 days [P = 0.281], respectively). In the RFA group, procedure-related complications including thermal injury-related complications, such as bile duct perforation or hemobilia, were not reported. The early complication (< 7 days) rates were not different between the groups (4.2% vs. 12.5%, P = 0.609), and there were no late complications (7-30 days) in both groups.
CONCLUSION
EB-RFA with a temperature-controlled catheter followed by SEMS placement for patients with inoperable MBS can be safe and feasible with acceptable biliary patency.",2020,"The early complication (< 7 days) rates were not different between the groups (4.2% vs. 12.5%, P = 0.609), and there were no late complications (7-30 days) in both groups.
","['48 patients were enrolled (24 in each group', 'Patients with inoperable cancer causing MBS', 'malignant biliary stricture', 'malignant biliary strictures (MBSs']","['EB-RFA', 'EB-RFA with a temperature-controlled catheter followed by SEMS placement', 'novel temperature-controlled catheter', 'radiofrequency ablation (RFA) group or the non-RFA', 'palliative endobiliary radiofrequency ablation', 'Endobiliary radiofrequency ablation (EB-RFA']","['duration of stent patency, overall survival (OS), and 30-day complication rate', 'early complication', 'late complications', 'Efficacy and safety', '90-day stent patency rate, median duration of stent patency, and median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0441290', 'cui_str': 'Metal stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449591', 'cui_str': 'Stent patency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231243', 'cui_str': 'Early complication'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",48.0,0.101132,"The early complication (< 7 days) rates were not different between the groups (4.2% vs. 12.5%, P = 0.609), and there were no late complications (7-30 days) in both groups.
","[{'ForeName': 'Huapyong', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Moon Jae', 'Initials': 'MJ', 'LastName': 'Chung', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'In Rae', 'Initials': 'IR', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Jo', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Jeong Youp', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Seung Woo', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Si Young', 'Initials': 'SY', 'LastName': 'Song', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Seungmin', 'Initials': 'S', 'LastName': 'Bang', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea. bang7028@yuhs.ac.'}]",Surgical endoscopy,['10.1007/s00464-020-07689-z']
3512,32488680,"Comparison of haemodynamic- and electroencephalographic-monitored effects evoked by four combinations of effect-site concentrations of propofol and remifentanil, yielding a predicted tolerance to laryngoscopy of 90.","This prospective study evaluates haemodynamic and electroencephalographic effects observed when administering four combinations of effect-site concentrations of propofol (Ce PROP ) and remifentanil (Ce REMI ), all yielding a single predicted probability of tolerance of laryngoscopy of 90% (P TOL = 90%) according to the Bouillon interaction model. We aimed to identify combinations of Ce PROP and Ce REMI along a single isobole of P TOL that result in favourable hypnotic and haemodynamic conditions. This knowledge could be of advantage in the development of drug advisory monitoring technology. 80 patients (18-90 years of age, ASA I-III) were randomized into four groups and titrated towards Ce PROP (Schnider model, ug⋅ml -1 ) and Ce REMI (Minto model, ng⋅ml -1 ) of respectively 8.6 and 1, 5.9 and 2, 3.6 and 4 and 2.0 and 8. After eleven minutes of equilibration, baseline measurements of haemodynamic endpoints and bispectral index were compared with three minutes of responsiveness measurements after laryngoscopy. Before laryngoscopy, bispectral index differed significantly (p < 0.0001) between groups in concordance with Ce PROP . Heart rate decreased with increasing Ce REMI (p = 0.001). The haemodynamic and arousal responses evoked by laryngoscopy were not significantly different between groups, but Ce PROP = 3.6 μg⋅ml -1 and Ce REMI = 4 ng⋅ml -1 evoked the lowest median value for ∆HR and ∆SAP after laryngoscopy. This study provides clinical insight on the haemodynamic and hypnotic consequences, when a model based predicted P TOL is used as a target for combined effect-site controlled target- controlled infusion of propofol and remifentanil. Heart rate and bispectral index were significantly different between groups despite a theoretical equipotency for P TOL , suggesting that each component of the anaesthetic state (immobility, analgesia, and hypnotic drug effect) should be considered as independent neurophysiological and pharmacological phenomena. However, claims of (in)accuracy of the predicted P TOL must be considered preliminary because larger numbers of observations are required for that goal.",2020,"Before laryngoscopy, bispectral index differed significantly (p < 0.0001) between groups in concordance with Ce PROP .","['80 patients (18-90\xa0years of age, ASA I-III']","['propofol (Ce PROP ) and remifentanil (Ce REMI ', 'propofol and remifentanil', 'Ce PROP and Ce REMI']","['haemodynamic and electroencephalographic effects', 'Heart rate and bispectral index', 'haemodynamic endpoints and bispectral index', 'Heart rate', 'haemodynamic and arousal responses evoked by laryngoscopy', 'ng⋅ml -1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]",,0.0494906,"Before laryngoscopy, bispectral index differed significantly (p < 0.0001) between groups in concordance with Ce PROP .","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'van den Berg', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands. j.p.van.den.berg@umcg.nl.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Absalom', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Venema', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Kalmar', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Van Amsterdam', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Hannivoort', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Proost', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Meier', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'T W L', 'Initials': 'TWL', 'LastName': 'Scheeren', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'M M R F', 'Initials': 'MMRF', 'LastName': 'Struys', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'H E M', 'Initials': 'HEM', 'LastName': 'Vereecke', 'Affiliation': 'Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00540-9']
3513,32488885,Effect of 3 Single Doses of Trazodone on QTc Interval in Healthy Subjects.,"This study evaluated the effect of 3 doses of a trazodone hydrochloride 6% oral drops solution on the QT interval of healthy volunteers. Subjects were randomly assigned to receive a single dose of trazodone 20 mg, 60 mg, and 140 mg, moxifloxacin 400 mg, and trazodone-matched placebo in 5 periods separated by 7-day washouts, according to a double-blind, crossover study design. Subjects were monitored continuously, and triplicate ECGs were extracted from baseline (predose) until 24 hours postdose. Blood samples for trazodone and moxifloxacin analyses were collected at the same time points. The concentration-QTc relationship assessed on placebo-adjusted change from baseline for Fridericia-corrected QT (ΔΔQTcF) was the primary end point. ΔΔQTcF values of 4.5, 12.3, and 19.8 ms for the 20-, 60-, and 140-mg doses were observed at the corresponding trazodone peak plasma concentrations. The upper bound of the 90%CI exceeded 10 ms for the 60- and the 140-mg doses. Time-matched analysis results were in line with these findings. No significant trazodone effect on heart rate or PR or QRS intervals and no clinically significant new morphological changes were present. In this moxifloxacin-validated ECG trial, trazodone had a modest, dose-dependent effect on cardiac repolarization, with no QTc prolongation observed with the 20-mg dose and an effect exceeding the values set in E14 guideline with the 60- and 140-mg doses. The effect on cardiac repolarization is unlikely to represent a clinical risk for ventricular proarrhythmia, but caution should be used with concomitant use of other medications that prolong QT or increase trazodone exposure.",2020,No significant trazodone effect on heart rate or PR or QRS intervals and no clinically significant new morphological changes were present.,"['healthy volunteers', 'Healthy Subjects']","['trazodone 20\xa0mg, 60\xa0mg, and 140\xa0mg, moxifloxacin 400\xa0mg, and trazodone-matched placebo', 'trazodone', 'trazodone hydrochloride 6% oral drops solution', 'Trazodone', 'moxifloxacin']","['concentration-QTc relationship', 'ΔΔQTcF values', 'heart rate or PR or QRS intervals', 'cardiac repolarization']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1126029', 'cui_str': 'moxifloxacin 400 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282369', 'cui_str': 'Trazodone hydrochloride'}, {'cui': 'C1273616', 'cui_str': 'Oral drops solution'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",,0.0666214,No significant trazodone effect on heart rate or PR or QRS intervals and no clinically significant new morphological changes were present.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Tellone', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Picollo', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Dragone', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Del Vecchio', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Milko', 'Initials': 'M', 'LastName': 'Radicioni', 'Affiliation': 'Cross Research SA, Arzo, Switzerland.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Leuratti', 'Affiliation': 'Cross Research SA, Arzo, Switzerland.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Calisti', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}]",Journal of clinical pharmacology,['10.1002/jcph.1640']
3514,32488889,Effectiveness of different parenting interventions on oral hygiene of cerebral palsy children: A randomized controlled trial.,"AIM
To assess the effectiveness of different parenting interventions for improving oral hygiene of cerebral palsy (CP) children aged 4-12 years.
METHODOLOGY AND RESULTS
A randomized controlled trial was done among 60 CP children and parents visiting a tertiary care center in New Delhi. The study population was randomly assigned to experimental or control group (30 in each group). Parents/caregivers in the experimental group (Group 1) received video-based dental health education (DHE) and the control group (Group 2) received conventional DHE. Each group also received two telephonic reinforcements at fourth and eighth week after the first intervention at baseline. The groups were assessed for sociodemographic, familial factors, medical history, oral hygiene practices, and oral hygiene status. At 3-month follow-up, the mean reduction in simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores was 0.27, 0.17, and 0.09, respectively, in Group 1 (P-value < .05). The mean reductions seen in Group 2 were 0.03 in OHI-S, 0.14 in PI, and 0.04 in GI index (P-value < .05, except for GI score: P-value = .6).
CONCLUSION
Video-based DHE is effective and brings about significant improvement in oral hygiene status and oral health among CP children.",2020,"At 3-month follow-up, the mean reduction in simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores was 0.27, 0.17, and 0.09, respectively, in Group 1 (P-value < .05).","['60 CP children and parents visiting a tertiary care center in New Delhi', 'cerebral palsy (CP) children aged 4-12 years', 'cerebral palsy children', 'CP children']","['Video-based DHE', 'parenting interventions', 'video-based dental health education (DHE) and the control group (Group 2) received conventional DHE']","['oral hygiene status and oral health', 'sociodemographic, familial factors, medical history, oral hygiene practices, and oral hygiene status', 'simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores']","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0610275,"At 3-month follow-up, the mean reduction in simplified oral hygiene index (OHI-S), plaque index (PI), and gingival index (GI) scores was 0.27, 0.17, and 0.09, respectively, in Group 1 (P-value < .05).","[{'ForeName': 'Vedha', 'Initials': 'V', 'LastName': 'Vpk', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Vikrant R', 'Initials': 'VR', 'LastName': 'Mohanty', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Aswini Y', 'Initials': 'AY', 'LastName': 'Balappanavar', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Juneja', 'Affiliation': 'Department of Pediatrics, Lok Nayak Hospital, New Delhi, India.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Shivam', 'Initials': 'S', 'LastName': 'Kapoor', 'Affiliation': 'Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12481']
3515,32488891,Use of Shear Wave Elastography for Quantitative Assessment of Muscle Stiffness After Botulinum Toxin Injection in Children With Cerebral Palsy.,"OBJECTIVES
This study aimed to investigate the stiffness of the gastrocnemius (GC) muscle with acoustic radiation force impulse (ARFI) elastography after botulinum toxin-A (BTX-A) injection in children with spastic cerebral palsy (CP) and to examine the relationship between elastographic and clinical parameters.
METHODS
This prospective randomized single-blind controlled clinical study included 49 lower extremities of 33 children with spastic CP. They were randomized into 2 groups: group 1 (n = 25 extremities in 17 children) received BTX-A injection and a home-based exercise program; group 2 (n = 24 extremities in 16 children) received only a home-based exercise program. Patients were evaluated in pretreatment and posttreatment periods in the first and third months with ARFI elastography, the Modified Ashworth Scale, Modified Tardieu Scale, Pediatric Functional Independence Measure, Gross Motor Function Classification System, and goniometric range of motion measurement of the ankle.
RESULTS
A statistically significant difference was found in elastography of the GC muscle in group 1 only at the first month after treatment (P < .05). No statistical difference was found in elastography of the GC after treatment in group 2. According to the Modified Ashworth Scale, Modified Tardieu Scale, and ankle passive range of motion, group 1 showed significant improvements after treatment (P < .05). Also, there was a significant correlation between these clinical parameters and elastographic measurements (P < .05).
CONCLUSIONS
According to the results of this study, the measurements from ARFI elastography combined with clinical parameters might be useful for evaluation of spasticity after BTX-A treatment in children with CP. Also, they might be useful in distinguishing patients who will benefit clinically, especially in the early stages of treatment.",2020,A statistically significant difference was found in elastography of the GC muscle in group 1 only at the first month after treatment (P < .05).,"['children with spastic cerebral palsy (CP', '49 lower extremities of 33 children with spastic CP', 'Children With Cerebral Palsy', 'children with CP']","['acoustic radiation force impulse (ARFI) elastography after botulinum toxin-A (BTX-A) injection', 'Botulinum Toxin Injection', 'Shear Wave Elastography', 'BTX-A injection and a home-based exercise program; group 2 (n = 24 extremities in 16 children) received only a home-based exercise program']","['Modified Ashworth Scale, Modified Tardieu Scale, and ankle passive range of motion', 'elastography of the GC muscle', 'Modified Ashworth Scale, Modified Tardieu Scale, Pediatric Functional Independence Measure, Gross Motor Function Classification System, and goniometric range of motion measurement of the ankle', 'clinical parameters and elastographic measurements', 'Muscle Stiffness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C1455736', 'cui_str': 'Acoustic radiations structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C1955928', 'cui_str': 'Tissue Elasticity Imaging'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C1955928', 'cui_str': 'Tissue Elasticity Imaging'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}]",49.0,0.0174009,A statistically significant difference was found in elastography of the GC muscle in group 1 only at the first month after treatment (P < .05).,"[{'ForeName': 'Huseyin', 'Initials': 'H', 'LastName': 'Bertan', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Julide', 'Initials': 'J', 'LastName': 'Oncu', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Vanli', 'Affiliation': 'Department of Radiology, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Alptekin', 'Affiliation': 'Bahçeşehir University Institute of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sahillioglu', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Kuran', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Yilmaz', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15342']
3516,32488909,Immune phenotype of tumor microenvironment predicts response to bevacizumab in neoadjuvant treatment of ER positive breast cancer.,"Antiangiogenic drugs are potentially a useful supplement to neoadjuvant chemotherapy for a subgroup of patients with HER2 (Human Epidermal Growth Factor receptor 2) negative breast cancer, but reliable biomarkers for improved response are lacking. Here, we report on a randomized phase II clinical trial to study the added effect of bevacizumab in neoadjuvant chemotherapy with FEC100 (5-fluorouracil, epirubicin and cyclophosphamide) and taxanes (n = 132 patients). Gene expression from the tumors was obtained before neoadjuvant treatment, and treatment response was evaluated by Residual Cancer Burden (RCB) at time of surgery. Bevacizumab increased the proportion of complete responders (RCB class 0) from 5% to 20% among patients with estrogen receptor (ER) positive tumors (p = 0.02). Treatment with bevacizumab was associated with improved eight year disease free survival (p = 0.03) among the good responders (RCB class 0 or I). Patients treated with paclitaxel (n = 45) responded better than those treated with docetaxel (n = 21) (p = 0.03). Improved treatment response was associated with higher proliferation rate and an immune phenotype characterized by high presence of classically activated M1 macrophages, activated NK cells and memory activated CD4 T-cells. Treatment with bevacizumab increased the number of adverse events, including hemorrhage, hypertension, infection and febrile neutropenia, but despite this, the ECOG status was not affected.",2020,"Improved treatment response was associated with higher proliferation rate and an immune phenotype characterized by high presence of classically activated M1 macrophages, activated NK cells and memory activated CD4 T-cells.","['n =\u2009132 patients', 'ER positive breast cancer']","['docetaxel', 'paclitaxel', 'Bevacizumab', 'FEC100 (5-fluorouracil, epirubicin and cyclophosphamide) and taxanes', 'bevacizumab']","['number of adverse events, including hemorrhage, hypertension, infection and febrile neutropenia', 'proportion of complete responders (RCB class 0', 'eight year disease free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2919268', 'cui_str': 'Residual cancer burden class'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",132.0,0.0215363,"Improved treatment response was associated with higher proliferation rate and an immune phenotype characterized by high presence of classically activated M1 macrophages, activated NK cells and memory activated CD4 T-cells.","[{'ForeName': 'Hedda', 'Initials': 'H', 'LastName': 'von der Lippe Gythfeldt', 'Affiliation': 'Dept of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Lien', 'Affiliation': 'Dept of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Tekpli', 'Affiliation': 'Dept of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Laxmi', 'Initials': 'L', 'LastName': 'Silwal-Pandit', 'Affiliation': 'Dept of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Borgen', 'Affiliation': 'Dept of Pathology, Oslo University Hospital Oslo, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Garred', 'Affiliation': 'Dept of Pathology, Oslo University Hospital Oslo, Norway.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Skjerven', 'Affiliation': 'Dept of Research, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Schlichting', 'Affiliation': 'Dept of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Lundgren', 'Affiliation': 'Dept of Oncology, St. Olavs University Hospital, Trondheim, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Wist', 'Affiliation': 'Dept of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Naume', 'Affiliation': 'Dept of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Vessela', 'Initials': 'V', 'LastName': 'Kristensen', 'Affiliation': 'Dept of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Børresen-Dale', 'Affiliation': 'Dept of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole Christian', 'Initials': 'OC', 'LastName': 'Lingjaerde', 'Affiliation': 'Dept of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Engebraaten', 'Affiliation': 'Dept of Oncology, Oslo University Hospital, Oslo, Norway.'}]",International journal of cancer,['10.1002/ijc.33108']
3517,32489170,Effects of a school readiness intervention on electrophysiological indices of external response monitoring in children in foster care.,"This study examined the impact of a school readiness intervention on external response monitoring in children in foster care. Behavioral and event-related potential (ERP) data were collected during a flanker task from children who received the Kids In Transition to School (KITS) Program (n = 26) and children who received services as usual (n = 19) before and after the intervention. While there were no significant group differences on the behavioral data, the ERP data for the two groups of children significantly differed. Specifically, in contrast to the children who received services as usual, the children who received the KITS Program displayed greater amplitude differences between positive and negative performance feedback over time for the N1, which reflects early attention processes, and feedback-related negativity, which reflects evaluation processes. In addition, although the two groups did not differ on amplitude differences between positive and negative performance feedback for these ERP components before the intervention, the children who received the KITS Program displayed greater amplitude differences than the children who received services as usual after the intervention. These results suggest that the KITS Program had an effect on responsivity to external performance feedback, which may be beneficial during the transition into kindergarten.",2020,"While there were no significant group differences on the behavioral data, the ERP data for the two groups of children significantly differed.","['children who received the Kids', 'children in foster care']",['school readiness intervention'],"['Behavioral and event-related potential (ERP) data', 'responsivity to external performance feedback', 'behavioral data, the ERP data']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0580719', 'cui_str': 'Child in foster care'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",26.0,0.0231013,"While there were no significant group differences on the behavioral data, the ERP data for the two groups of children significantly differed.","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR, USA.'}, {'ForeName': 'Katherine C', 'Initials': 'KC', 'LastName': 'Pears', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR, USA.'}, {'ForeName': 'Jennifer Martin', 'Initials': 'JM', 'LastName': 'McDermott', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, OR, USA.'}]",Development and psychopathology,['10.1017/S0954579420000164']
3518,32489201,A randomised evaluation of intercostal block as an adjunct to epidural analgesia for post-thoracotomy pain.,"Background and Aims
Post-thoracotomy pain can be severe and disabling. The aim of this study was to examine the efficacy of intercostal nerve block when used as adjunct to thoracic epidural analgesia in patients undergoing posterolateral thoracotomy.
Methods
This was a parallel-group randomised patient and assessor-blinded study carried out at a tertiary-referral cancer center. We included 60 adult patients undergoing elective lung resection under general anaesthesia with thoracic epidural analgesia. In addition, the intervention arm received single-shot intercostal blocks with 10 ml of 0.25% bupivacaine at the level of and two levels above and below the thoracotomy. We assessed post-operative pain scores at 2 to 4 hours and 18 to 24 hours after surgery, peri-operative fentanyl requirement, percentage of patients who needed fentanyl PCA and maximum volume achieved on bedside spirometry 18 to 24 hours after surgery. Groups were compared using the unpaired t -test for continuous data and the chi square test for categorical data at a 5% level of significance.
Results
2 to 4 hours post-operatively, mean pain scores at rest were 3.0 in both groups (difference 0.04, 95% CI -1.1 to + 1.1) and on coughing were 4.6 (ICB group) and 4.9 (C group) (difference 0.32, 95% CI -1.0 to + 1.6). There were no differences between the groups for any of the other outcomes.
Conclusion
Addition of intercostal block to epidural analgesia does not confer any benefit in terms of post-operative pain, fentanyl requirements or volume achieved on spirometry.",2020,"Conclusion
Addition of intercostal block to epidural analgesia does not confer any benefit in terms of post-operative pain, fentanyl requirements or volume achieved on spirometry.","['patients undergoing posterolateral thoracotomy', '60 adult patients undergoing elective lung resection under general anaesthesia with thoracic epidural analgesia']","['intercostal block', 'intercostal nerve block', 'thoracic epidural analgesia', 'single-shot intercostal blocks with 10 ml of 0.25% bupivacaine']","['post-operative pain scores', 'mean pain scores', 'coughing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442951', 'cui_str': 'Posterolateral thoracotomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]",60.0,0.200673,"Conclusion
Addition of intercostal block to epidural analgesia does not confer any benefit in terms of post-operative pain, fentanyl requirements or volume achieved on spirometry.","[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Asharab', 'Initials': 'A', 'LastName': 'Tadvi', 'Affiliation': 'Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Sabita', 'Initials': 'S', 'LastName': 'Jiwnani', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Karimundackal', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Pramesh', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_714_19']
3519,32489203,Supraclavicular or infraclavicular subclavian vein: Which way to go- A prospective randomized controlled trial comparing catheterization dynamics using ultrasound guidance.,"Background and Aims
Subclavian vein (SCV) catheterization via the supraclavicular (SSV) or infraclavicular (ISV) approaches under real time ultrasonographic (USG) guidance is being performed routinely in critically ill patients in ICU.The aim of this study is comparative evaluation of SSV and ISV approaches in terms of success rate, time taken and incidence of complications.
Settings and Design
In this prospective study, 110 critically ill patients were randomly divided into two groups of 55 each. Right SCV catheterization was performed using real time USG by single experienced operator.
Methods
Success rate, first attempt success rate, time taken for venous visualization, puncture, catheterization, total procedure, incidence of mechanical, and infectious complications were variables used for comparison among groups.
Statistical Analysis Used
Normality tests were performed using the Kolmogorov-Smirnov test. All data are expressed as the mean (SD), number (%), or median [interquartile range (IQR)] as indicated. Data were compared using the χ 2 test, the Mann-Whitney U-test, Fisher's exact test and Student's t -test as appropriate.
Results
Total procedural time was significantly lesser in SSV group than ISV group ( P < 0.0001). Time for visualization, puncture and catheterization were significantly higher in ISV group ( P < 0.001). Success rate was 100% in both groups. First attempt success rate was more in SSV ( P = 0.171).Two incidence of malposition was found in ISV group. Infectious complications were comparable in both groups.
Conclusions
Real time USG-guided supraclavicular subclavian approach is a viable and preferable alternative with significantly lesser total procedural time, similar success rate, fewer attempts, faster and lesser complication rates as compared with infraclavicular approach.",2020,"Results
Total procedural time was significantly lesser in SSV group than ISV group ( P < 0.0001).","['critically ill patients', '110 critically ill patients']","['Right SCV catheterization', ' and Aims\n\n\nSubclavian vein (SCV) catheterization via the supraclavicular (SSV) or infraclavicular (ISV', 'Supraclavicular or infraclavicular subclavian vein', 'ultrasound guidance']","['complication rates', 'Success rate', 'Total procedural time', 'Success rate, first attempt success rate, time taken for venous visualization, puncture, catheterization, total procedure, incidence of mechanical, and infectious complications', 'Infectious complications', 'Time for visualization, puncture and catheterization']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0489887', 'cui_str': 'Structure of right subclavian vein'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",110.0,0.0291693,"Results
Total procedural time was significantly lesser in SSV group than ISV group ( P < 0.0001).","[{'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Prasad', 'Affiliation': 'Department of Anaesthesiolgy and Critical Care, Dr S.N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Soni', 'Affiliation': 'Department of Anaesthesiolgy and Critical Care, Dr S.N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Janweja', 'Affiliation': 'Department of Anaesthesiolgy and Critical Care, Dr S.N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Jogendra S', 'Initials': 'JS', 'LastName': 'Rajpurohit', 'Affiliation': 'Department of Anaesthesiolgy and Critical Care, Dr S.N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Nivas', 'Affiliation': 'Department of Anaesthesiolgy and Critical Care, Dr S.N. Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Jagdish', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiolgy and Critical Care, Dr S.N. Medical College, Jodhpur, Rajasthan, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_930_19']
3520,32489204,"Development, validation and evaluation of a novel self-instructional module in patients with chronic non-specific low back pain.","Background
Low back pain (LBP) is ranked highest in terms of disability-adjusted life-years lived. Patient education and self-management have shown to play a crucial role in the overall pain management. However, the literature on the same with respect to Indian context is still lacking. The study was aimed to develop, validate and assess the acceptability and effectiveness of self-instructional educational module among Indian chronic LBP (CLBP) patients.
Methods
A prospective single-arm open-label study was conducted in a pain clinic of a tertiary care public hospital in North India with 'Backcare booklet-self-instructional module (SIM)' as an intervention in patients with CLBP. SIM was developed with the intent to provide up-to-date evidence-based information in an easy understanding way to patients with CLBP. 132 patients were administered SIM with a single session of verbal explanation. Pain intensity (numeric rating scale [NRS]), disability, fear-avoidance belief Questionnaire (FABQ), quality of life (EQ5D) and knowledge level were assessed at baseline and after 3 months of intervention. Student's paired t -test and Chi-square test were used. Data were analysed using SPSS version 15.0.
Results
120 patients successfully completed the 3 months' follow-up. Significant reductions were observed in pain intensity (76[12] vs 55 [15, P < 0.01); disability (51[14] vs 43 [10], P < 0.01); FABQ (46[12] vs 41 [10], P < 0.01); EQ5D (0.35 [0.27] vs 0.18 [0.26], P < 0.01).
Conclusion
Backcare booklet as an intervention, along with usual pharmacological care is a cost-effective educational medium to promote self-management of CLBP in the clinical outpatient settings.",2020,"Significant reductions were observed in pain intensity (76[12] vs 55 [15, P < 0.01); disability (51[14] vs 43 [10], P < 0.01); FABQ (46[12] vs 41 [10], P < 0.01); EQ5D (0.35 [0.27] vs 0.18 [0.26], P < 0.01).
","['patients with CLBP', ""120 patients successfully completed the 3 months' follow-up"", 'pain clinic of a tertiary care public hospital in North India with ', 'patients with chronic non-specific low back pain', 'Indian chronic LBP (CLBP) patients', '132 patients were administered']","['Backcare booklet-self-instructional module (SIM', 'self-instructional educational module', 'SIM']","['EQ5D', 'pain intensity', 'Pain intensity (numeric rating scale [NRS]), disability, fear-avoidance belief Questionnaire (FABQ), quality of life (EQ5D) and knowledge level', 'disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",132.0,0.066197,"Significant reductions were observed in pain intensity (76[12] vs 55 [15, P < 0.01); disability (51[14] vs 43 [10], P < 0.01); FABQ (46[12] vs 41 [10], P < 0.01); EQ5D (0.35 [0.27] vs 0.18 [0.26], P < 0.01).
","[{'ForeName': 'Babita', 'Initials': 'B', 'LastName': 'Ghai', 'Affiliation': 'Department of Anesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Gudala', 'Affiliation': 'Clinical Research Unit, Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Mohali, Punjab, India.'}, {'ForeName': 'Mir M', 'Initials': 'MM', 'LastName': 'Asrar', 'Affiliation': 'Clinical Research Unit, Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Mohali, Punjab, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Chanana', 'Affiliation': 'Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Raju', 'Initials': 'R', 'LastName': 'Kanukula', 'Affiliation': 'Clinical Research Unit, Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Mohali, Punjab, India.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Bansal', 'Affiliation': 'Clinical Research Unit, Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Mohali, Punjab, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_779_19']
3521,32489310,Expression and pathogenesis of VCAM-1 and VLA-4 cytokines in multiple myeloma.,"Objective
The objective of this study is to investigate the expression of Vascular cell adhesion molecule-1 (VCAM-1) and very late appearing antigen-4 (VLA-4) cytokines in MM (multiple Myeloma).
Method
Forty patients with MM are selected as the experimental group and 30 healthy persons as the control group. Flow cytometry is used to detect the expression of VCAM-1 (CD106), VLA-4 (CD49d), CD38 and CD138 antigens in experimental group and control group. ELISA (Enzyme Linked Immunosorbent Assay) is used to detect the concentration of VCAM-1 in serum of experimental group and control group. RT-PCR is used to detect the expression of VCAM-1.
Results
The positive rate and antigen expression rate of VACM-1 antigen in the experimental group were significantly higher than those in the control group (P < 0.05). There were statistical differences of VLA-4 and VCAM-1 antigens between the initial diagnosis group and the relapse/refractory group, and between the relapse/refractory group and the platform stage group (P < 0.05). There were significant differences between VLA-4 antigen and VACM-1 antigen, phase I and phase II, and between phase I and phase III (P < 0.05). The concentration of VCAM-1 and the expression of VCAM-1 mRNA in the experimental group were significantly higher than (P < 0.01). In the different stages of ISS (International Staging System) and different disease groups in the experimental group, the concentration of VCAM-1 and the expression level of VCAM-1 mRNA are significantly different among the three groups of stage I, II and III (P < 0.01). There is a significant difference between the initial diagnosis group, the relapse/refractory group and the platform group (P < 0.05).
Conclusion
There are abnormal expressions of adhesion molecules VCAM-1 and VLA-4 in multiple myeloma patients, which are related to ISS staging.",2020,The concentration of VCAM-1 and the expression of VCAM-1 mRNA in the experimental group were significantly higher than (P < 0.01).,['Forty patients with MM are selected as the experimental group and 30 healthy persons as the control group'],['ELISA'],"['concentration of VCAM-1 and the expression level of VCAM-1 mRNA', 'VLA-4 and VCAM-1 antigens', 'concentration of VCAM-1 and the expression of VCAM-1 mRNA', 'Expression and pathogenesis of VCAM-1 and VLA-4 cytokines', 'expression of VCAM-1 (CD106), VLA-4 (CD49d), CD38 and CD138 antigens', 'positive rate and antigen expression rate of VACM-1 antigen', 'VLA-4 antigen and VACM-1 antigen, phase I and phase II']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0543483', 'cui_str': 'pathogenesis'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",40.0,0.0135863,The concentration of VCAM-1 and the expression of VCAM-1 mRNA in the experimental group were significantly higher than (P < 0.01).,"[{'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Hao', 'Affiliation': 'Department of Nuclear Medicine, LuHe Hospital, Capital Medical University, Beijing City 101149, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Nuclear Medicine, Peaking University First Hospital, Beijing City 100011, China.'}, {'ForeName': 'Rongfu', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Nuclear Medicine, Peaking University First Hospital, Beijing City 100011, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yan', 'Affiliation': 'Department of Nuclear Medicine, Peaking University First Hospital, Beijing City 100011, China.'}, {'ForeName': 'Ruchen', 'Initials': 'R', 'LastName': 'Peng', 'Affiliation': 'Department of Medical Imaging Center Nuclear Medicine, LuHe Hospital, Capital Medical University, Beijing City 101149, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2020.04.031']
3522,32489393,"The influence of progressive-chronic and acute sodium bicarbonate supplementation on anaerobic power and specific performance in team sports: a randomized, double-blind, placebo-controlled crossover study.","Background
The aims of this study were to verify the effect of progressive-chronic and acute sodium bicarbonate (SB) supplementation on the anaerobic capacity, blood acid-base balance, and discipline-specific performance in team sports disciplines.
Methods
Twenty-four trained male field hockey players completed a randomized, placebo-controlled, crossover trial of either progressive-chronic (increments from 0.05 up to 0.2 g/kg) or an acute one-off dose (0.2 g/kg) supplementation protocol. Before and after treatments, athletes completed an exercise protocol that comprised of a discipline-specific field performance test conducted between two separate Wingate anaerobic tests (WAnTs).
Results
Progressive-chronic SB supplementation improved anaerobic capacity in the first bout of WAnTs, as observed based on an increase in mean power (MP: 575 ± 71 vs. 602 ± 67 W, p = 0.005, ~ + 4.7%), peak power (PP: 749 ± 94 vs. 777 ± 96 W, p = 0.002, ~ + 3.7%), power carry threshold (P CT ) at 97% PP (727 ± 91 vs. 753 ± 93 W, p = 0.002, ~ + 3.6%) and average power over P CT (739 ± 94 vs. 765 ± 95 W, p = 0.001, ~ + 3.5%). Acute SB supplementation had no effect on anaerobic capacity. However, an improvement in time during discipline-specific field performance test was observed after progressive-chronic (919 ± 42 vs. 912 ± 27 s, p = 0.05; ~ - 0.8%) and acute (939 ± 26 vs. 914 ± 22 s, p = 0.006, ~ 2.7%) SB supplementation. Acute SB supplementation also improved post-exercise parameters of acid-base balance (based on blood pH, bicarbonate concentration and base excess) compared to no supplementation or placebo.
Conclusions
Our study indicates that both chronic and acute SB supplementation positively supports discipline-specific performance among field hockey athletes. Moreover, the chronic protocol supported anaerobic power indices before the inset of exercise-induced fatigue but had no significant impact afterwards. However, only the acute protocol significantly affected the buffering capacity, which can be used to determine athlete's performance during high-intensity sporting events. This study design therefore highlighted that future studies focusing on sodium bicarbonate supplementation in team sports should concentrate on the efficiency of chronic and acute supplementation in varying time frames.",2020,"Moreover, the chronic protocol supported anaerobic power indices before the inset of exercise-induced fatigue but had no significant impact afterwards.","['field hockey athletes', 'Methods\n\n\nTwenty-four trained male field hockey players', 'team sports']","['Acute SB supplementation', 'sodium bicarbonate supplementation', 'progressive-chronic and acute sodium bicarbonate (SB) supplementation', 'placebo']","['anaerobic power and specific performance', 'anaerobic capacity, blood acid-base balance, and discipline-specific performance', 'blood pH, bicarbonate concentration and base excess', 'anaerobic capacity', 'time during discipline-specific field performance test']","[{'cui': 'C0016074', 'cui_str': 'Field hockey'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0201985', 'cui_str': 'Delta base, blood'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",24.0,0.469857,"Moreover, the chronic protocol supported anaerobic power indices before the inset of exercise-induced fatigue but had no significant impact afterwards.","[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Durkalec-Michalski', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Wojska Polskiego 31, 60-624 Poznań, Poland.'}, {'ForeName': 'Paulina M', 'Initials': 'PM', 'LastName': 'Nowaczyk', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Wojska Polskiego 31, 60-624 Poznań, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Adrian', 'Affiliation': 'Department of Theory and Methodology of Team Sport Games, Poznań University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kamińska', 'Affiliation': 'Department od Physiology and Biochemistry, Poznań University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Podgórski', 'Affiliation': 'Department od Physiology and Biochemistry, Poznań University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}]",Nutrition & metabolism,['10.1186/s12986-020-00457-9']
3523,32489494,Use of video-based multimedia information to reduce anxiety before office hysteroscopy.,"Introduction
Use of multimedia tools has been shown to improve patient comprehension, reduce pre-procedural anxiety, and increase patient satisfaction in various surgical settings.
Aim
To investigate the impact of video-based multimedia information (MMI) on the anxiety levels of patients undergoing office hysteroscopy (OH).
Material and methods
All consecutive women aged 18-65 years and scheduled for diagnostic OH were enrolled in this prospective randomized study. Subjects were assigned to receive video-based MMI or conventional written information (controls). The trait and state anxiety were assessed using the State and Trait Anxiety Inventory (STAI) before the MMI or written information. STAI-state (STAI-S) was repeated after application of the MMI or written information. All patients underwent a standardized transvaginal hysteroscopy procedure by the same gynecologist. Following the hysteroscopy, patient satisfaction and procedural pain were ranked using a Likert scale and visual analogue scale.
Results
Fifty-two patients were randomized to receive a video-based MMI, and 52 patients were randomized to receive written information. Post-information STAI-S score was significantly lower in the MMI group than that of the written information group (45.0 ±8.0 vs. 49.4 ±8.4, p < 0.001, 95% CI for the difference: 1.36-7.79). Moreover, the satisfaction rate of the video group was significantly higher than the satisfaction rate of the controls (92.3% vs. 63.5%, p < 0.001). VAS score of procedural pain was similar for the two groups.
Conclusions
A video-based MMI before OH might be preferred to conventional information methods in order to reduce the pre-procedural anxiety and to increase patients' satisfaction.",2020,"Post-information STAI-S score was significantly lower in the MMI group than that of the written information group (45.0 ±8.0 vs. 49.4 ±8.4, p < 0.001, 95% CI for the difference: 1.36-7.79).","['consecutive women aged 18-65 years and scheduled for diagnostic OH', 'Fifty-two patients', 'patients undergoing office hysteroscopy (OH']","['video-based multimedia information', 'standardized transvaginal hysteroscopy procedure', 'video-based MMI', 'video-based multimedia information (MMI', 'video-based MMI or conventional written information (controls', 'MMI']","['State and Trait Anxiety Inventory (STAI', 'Likert scale and visual analogue scale', 'satisfaction rate', 'Post-information STAI-S score', 'trait and state anxiety', 'VAS score of procedural pain', 'anxiety levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",52.0,0.067581,"Post-information STAI-S score was significantly lower in the MMI group than that of the written information group (45.0 ±8.0 vs. 49.4 ±8.4, p < 0.001, 95% CI for the difference: 1.36-7.79).","[{'ForeName': 'Aysu', 'Initials': 'A', 'LastName': 'Akca', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gulseren', 'Initials': 'G', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aytul Corbacioglu', 'Initials': 'AC', 'LastName': 'Esmer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Yuksel', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, GOP Taksim Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nadiye', 'Initials': 'N', 'LastName': 'Koroglu', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey.'}, {'ForeName': 'Berna Aslan', 'Initials': 'BA', 'LastName': 'Cetin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey.'}]",Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques,['10.5114/wiitm.2019.89378']
3524,32489497,Effects of ultrasound guided ganglion stellate blockade on intraoperative and postoperative hemodynamic responses in laparoscopic gynecologic surgery.,"Introduction
Laparoscopic gynecologic surgery is one of the most well-known procedures. Pneumoperitoneum with carbon dioxide insufflation can cause unfavorable hemodynamic effects due to catecholamine and vasopressin release.
Aim
To examine the effects of stellate ganglion block on hemodynamic response and postoperative pain.
Material and methods
In a prospective double blinded randomized parallel study we included 40 patients with ASA physical status I and II, aged between 18 and 50 years with a gynecologic problem candidate for laparoscopic surgery under general anesthesia. The patients were randomly divided into two groups. Fifteen minutes before anesthesia induction, the patients underwent ultrasound guided stellate ganglion block with 10 ml of lidocaine 1% and the control group underwent stellate ganglion block using 10 ml of distilled water as placebo. After induction of general anesthesia, systolic and diastolic blood pressure and heart rate were recorded, especially after blowing of CO 2 gas, the position change, depletion of CO 2 , and tracheal extubation in recovery. The postoperative pain was calculated using the visual analogue scale (VAS) at three times (0, 30, and 24 h after surgery).
Results
Our results showed that mean systolic and diastolic blood pressure and heart rate did not show any significant difference at the measurement times (p > 0.05), and mean VAS of patients in the two groups was significantly different for the three measurement times except 24 h after surgery (p < 0.05).
Conclusions
Stellate ganglion block before laparoscopic gynecologic surgery has no significant effect on intraoperative and postoperative hemodynamic responses; however, it can decrease VAS in the early postoperative period.",2020,"Our results showed that mean systolic and diastolic blood pressure and heart rate did not show any significant difference at the measurement times (p > 0.05), and mean VAS of patients in the two groups was significantly different for the three measurement times except 24 h after surgery (p < 0.05).
","['laparoscopic gynecologic surgery', '40 patients with ASA physical status I and II, aged between 18 and 50 years with a gynecologic problem candidate for laparoscopic surgery under general anesthesia']","['Laparoscopic gynecologic surgery', 'control group underwent stellate ganglion block using 10 ml of distilled water as placebo', 'ultrasound guided stellate ganglion block with 10 ml of lidocaine', 'Pneumoperitoneum with carbon dioxide insufflation', 'stellate ganglion block', 'ultrasound guided ganglion stellate blockade']","['mean VAS', 'mean systolic and diastolic blood pressure and heart rate', 'postoperative pain', 'visual analogue scale (VAS', 'intraoperative and postoperative hemodynamic responses', 'hemodynamic response and postoperative pain', 'systolic and diastolic blood pressure and heart rate']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262498', 'cui_str': 'Female genital tract problem'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0038246', 'cui_str': 'Structure of stellate ganglion'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",40.0,0.0859202,"Our results showed that mean systolic and diastolic blood pressure and heart rate did not show any significant difference at the measurement times (p > 0.05), and mean VAS of patients in the two groups was significantly different for the three measurement times except 24 h after surgery (p < 0.05).
","[{'ForeName': 'Poupak', 'Initials': 'P', 'LastName': 'Rahimzadeh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Anesthesiology, Ahwaz University of Medical Sciences, Ahwaz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khodaverdi', 'Affiliation': 'Department of Anesthesiology, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Seyed Hamid Reza', 'Initials': 'SHR', 'LastName': 'Faiz', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.'}]",Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques,['10.5114/wiitm.2019.89653']
3525,32485641,"Caloric restriction, resting metabolic rate and cognitive performance in Non-obese adults: A post-hoc analysis from CALERIE study.","Physical activity (PA) has been proposed as a determinant of cognitive function and is one component of energy balance (EB). EB is the difference between energy intake (EI) and the total daily energy expenditure (TDEE). TDEE is a combination of resting metabolic rate (RMR), thermic effect of food and PA. The potential role of each of these components on cognitive function has not yet been systemically investigated. We aim to evaluate the association between each component of EB on cognition, using baseline and longitudinal data from a clinical trial of caloric restriction (CR). This is a parallel-group, randomized clinical trial comparing two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI ≥ 22 kg/m2 and <28 kg/m2. Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content were evaluated, as well as RMR, TDEE, cognitive performance and baseline energy intake. A 30 min/day of a moderate level on a minimum of 5 days/week was advised as PA measure. Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass. EB and homeostasis are crucial to modulate the RMR. Moreover, RMR presents an important influence on cognitive function in individuals submitted to CR in a long term.",2020,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","['two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI', 'Non-obese adults']","['TDEE', 'Physical activity (PA', 'caloric restriction (CR']","['cognitive performance', 'RMR, TDEE, cognitive performance and baseline energy intake', 'total daily energy expenditure (TDEE', 'cognitive function', 'resting metabolic rate (RMR), thermic effect of food and PA', 'Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content', 'cognitive performance and the RMR', 'Caloric restriction, resting metabolic rate and cognitive performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]",220.0,0.044031,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","[{'ForeName': 'Ruth Bartelli', 'Initials': 'RB', 'LastName': 'Grigolon', 'Affiliation': 'Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil; Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada; Centre for Neuroscience Studies (CNS), Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Alisson Paulino', 'Initials': 'AP', 'LastName': 'Trevizol', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada; Brain and Cognition Foundation, Toronto, ON, Canada.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada. Electronic address: rodrigomansur71@uol.com.br.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.018']
3526,32485656,Impulsiveness as a moderator of amphetamine treatment response for cocaine use disorder among ADHD patients.,"BACKGROUND
Amphetamines are a first-line treatment for ADHD and have shown promise for the treatment of cocaine use disorder (CUD), both alone and with comorbid ADHD. Impulsiveness is a key aspect of both ADHD and substance use disorders. We sought to understand the role of baseline impulsiveness in the treatment of comorbid CUD and ADHD.
METHODS
In a post hoc analysis (N = 76) of a 14-week, double-blind, randomized, placebo-controlled trial of mixed amphetamine salts-extended release (MAS-ER) for comorbid ADHD and CUD, we examined the relationship between treatment response and participants' baseline Barratt Impulsiveness Scale (BIS-11) score by comparing those with scores below versus above the median. In the original trial, participants received daily 60 mg MAS-ER, 80 mg MAS-ER, or placebo, in conjunction with cognitive behavioral therapy.
RESULTS
The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05).
CONCLUSIONS
The results show an association between higher within-group trait impulsiveness, as measured by the BIS-11, and response to MAS-ER for CUD in a cohort with comorbid ADHD. This result further demonstrates that impulsiveness is an important factor when considering treatment options for patients with CUD and that higher baseline impulsiveness may predict response to treatment with psychostimulants for CUD.",2020,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05).
","['ADHD patients', 'patients with CUD']","['mixed amphetamine salts-extended release (MAS-ER', 'daily 60\u2009mg MAS-ER, 80\u2009mg\u2009MAS-ER, or placebo, in conjunction with cognitive behavioral therapy', 'amphetamine', 'placebo']",['baseline Barratt Impulsiveness Scale (BIS-11) score'],"[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.145481,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05).
","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Blevins', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States. Electronic address: derek.blevins@nyspi.columbia.edu.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'Mental Health Data Science, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, NY, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grabowski', 'Affiliation': 'Department of Psychiatry, University of Minnesota Twin Cities, Minneapolis, MN, United States.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108082']
3527,32485663,"Effects of Exercises on a Hard, Soft, and Sand Surface on Functional Outcomes of Community-Dwelling Older Individuals: A Randomized Controlled Trial.","This single-blind, randomized controlled trial compared the effects of Thai dance exercise training on hard, soft, and sand surfaces on the functional outcomes of 120 community-dwelling older adults (40 subjects/group). The subjects were involved in a Thai dance exercise program on each surface, according to their groups, for 50 min/day, 3 days/week, for 6 weeks. The functional outcomes were assessed prior to training, at Week 3, and Week 6 after training. Subjects showed a significant improvement in all functional tests at 3 and 6 weeks after training, particularly in those who were trained on a sand surface and a soft surface (7-30% improvement, p < .05). The improvement was especially demonstrated in the complex and demanding motor activities after exercise on a soft and sand surface. Aside from attempting to modify training programs on a hard surface, the current findings suggest an alternative and cost-effective program to promote the levels of independence and safety that can be applied easily in clinical, home-based, and community settings.",2020,"Subjects showed a significant improvement in all functional tests at 3 and 6 weeks after training, particularly in those who were trained on a sand surface and a soft surface (7-30% improvement, p < .05).","['120 community-dwelling older adults (40 subjects/group', 'Community-Dwelling Older Individuals']","['Exercises on a Hard, Soft, and Sand Surface', 'Thai dance exercise training']","['functional tests', 'complex and demanding motor activities']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C4759711', 'cui_str': 'Sand'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",120.0,0.0148641,"Subjects showed a significant improvement in all functional tests at 3 and 6 weeks after training, particularly in those who were trained on a sand surface and a soft surface (7-30% improvement, p < .05).","[{'ForeName': 'Chonticha', 'Initials': 'C', 'LastName': 'Kaewjoho', 'Affiliation': ''}, {'ForeName': 'Thiwabhorn', 'Initials': 'T', 'LastName': 'Thaweewannakij', 'Affiliation': ''}, {'ForeName': 'Lugkana', 'Initials': 'L', 'LastName': 'Mato', 'Affiliation': ''}, {'ForeName': 'Saowanee', 'Initials': 'S', 'LastName': 'Nakmaroeng', 'Affiliation': ''}, {'ForeName': 'Supaporn', 'Initials': 'S', 'LastName': 'Phadungkit', 'Affiliation': ''}, {'ForeName': 'Sugalya', 'Initials': 'S', 'LastName': 'Amatachaya', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0246']
3528,32485664,Acceptance and Feasibility of Seated Elliptical Pedaling to Replace Sedentary Behavior in Older Adults.,"The purpose of this study was to explore the feasibility and acceptability of a seated pedaling device to reduce sedentary behavior (SB) in the homes of older adults.
METHODS
Each participant (N = 20) was outfitted with an activity monitor and seated pedaling device in the home for 7 days and randomly assigned to one of four light-intensity pedaling groups (15, 30, 45, and 60 min/day).
RESULTS
There was 100% adherence in all groups and significant group differences in the minutes pedaled per day (p < .001), with no significant difference in the total pedaling days completed (p = .241). The 15-, 30-, 45-, and 60-min groups experienced a 4.0%, 5.4%, 10.6%, and 11.3% reduction in SB on the days pedaled, respectively.
CONCLUSION
Clinically relevant reductions in SB time were achievable in this 1-week trial. Long-term adherence and the impact of replacing SB with seated light activities on geriatric-relevant health outcomes should be investigated.",2020,"There was 100% adherence in all groups and significant group differences in the minutes pedaled per day (p < .001), with no significant difference in the total pedaling days completed (p = .241).","['homes of older adults', 'Older Adults']","['seated pedaling device', 'Seated Elliptical Pedaling to Replace Sedentary Behavior', 'replacing SB with seated light activities']","['SB time', 'sedentary behavior (SB']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0767265,"There was 100% adherence in all groups and significant group differences in the minutes pedaled per day (p < .001), with no significant difference in the total pedaling days completed (p = .241).","[{'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Lerma', 'Affiliation': ''}, {'ForeName': 'Chi C', 'Initials': 'CC', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Swartz', 'Affiliation': ''}, {'ForeName': 'Hotaka', 'Initials': 'H', 'LastName': 'Maeda', 'Affiliation': ''}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Strath', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0388']
3529,32485734,Cardiovascular (CV) Benefit of Empagliflozin Across the Spectrum of CV Risk Factor Control in the EMPA-REG OUTCOME Trial.,"CONTEXT
Control of multiple cardiovascular (CV) risk factors reduces CV events in individuals with type 2 diabetes (T2D).
OBJECTIVE
To investigate this association in a contemporary clinical trial population, including how CV risk factor control affects the CV benefits of empagliflozin, a sodium-glucose co-transporter-2 inhibitor.
DESIGN
Post hoc analysis.
SETTING
Randomized CV outcomes trial (EMPA-REG OUTCOME).
INTERVENTION
Empagliflozin or placebo.
MAIN OUTCOME MEASURES
Risk of CV outcomes - including treatment effect of empagliflozin - by achievement of seven goals for CV risk factor control at baseline: glycated hemoglobin <7.5%, low-density lipoprotein cholesterol <100 mg/dL or statin use, systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, pharmacological renin-angiotensin-aldosterone system blockade, normoalbuminuria, aspirin use, non-smoking.
RESULTS
In the placebo group, the hazard ratio (HR) for CV death was 4.00 (95% CI 2.26-7.11) and 2.48 (1.52-4.06) for patients achieving only 0-3 or 4-5 risk factor goals at baseline, respectively, compared to those achieving 6-7 goals. Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]). Empagliflozin significantly reduced these outcomes across all risk factor control categories (P>0.05 for treatment-by-subgroup interactions).
CONCLUSIONS
CV risk in EMPA-REG OUTCOME was inversely associated with baseline CV risk factor control. Empagliflozin's cardioprotective effect was consistent regardless of multiple baseline risk factor control.",2020,"Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]).",['individuals with type 2 diabetes (T2D'],"['empagliflozin', 'Empagliflozin or placebo', 'Empagliflozin', 'EMPA', 'placebo']","['hazard ratio (HR) for CV death', 'risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke', 'risk factor control categories', 'baseline CV risk factor control', '3-point major adverse CV events', 'Risk of CV outcomes - including treatment effect of empagliflozin - by achievement of seven goals for CV risk factor control at baseline: glycated hemoglobin <7.5%, low-density lipoprotein cholesterol <100 mg/dL or statin use, systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, pharmacological renin-angiotensin-aldosterone system blockade, normoalbuminuria, aspirin use, non-smoking.\nRESULTS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.196854,"Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]).","[{'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fitchett', 'Affiliation': ""St. Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mattheus', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa321']
3530,32485741,Response to Letter to the Editor from Melanson et al (second letter): Twice as high diet-induced thermogenesis after breakfast vs dinner on high-calorie as well as low-calorie meals.,,2020,,[],[],[],[],[],[],,0.0162441,,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa353']
3531,32485785,"Stem cell mobilization with plerixafor and healing of diabetic ischemic wounds: A phase IIa, randomized, double-blind, placebo-controlled trial.","Bone marrow-derived cells contribute to tissue repair, but traffic of hematopoietic stem/progenitor cells (HSPCs) is impaired in diabetes. We therefore tested whether HSPC mobilization with the CXCR4 antagonist plerixafor improved healing of ischemic diabetic wounds. This was a pilot, phase IIa, double-blind, randomized, placebo-controlled trial (NCT02790957). Patients with diabetes with ischemic wounds were randomized to receive a single subcutaneous injection of plerixafor or saline on top of standard medical and surgical therapy. The primary endpoint was complete healing at 6 months. Secondary endpoints were wound size, transcutaneous oxygen tension (TcO 2 ), ankle-brachial index (ABI), amputations, and HSPC mobilization. Twenty-six patients were enrolled: 13 received plerixafor and 13 received placebo. Patients were 84.6% males, with a mean age of 69 years. HSPC mobilization was successful in all patients who received plerixafor. The trial was terminated after a preplanned interim analysis of 50% of the target population showed a significantly lower healing rate in the plerixafor vs the placebo group. In the final analysis data set, the rate of complete healing was 38.5% in the plerixafor group vs 69.2% in the placebo group (chi-square P = .115). Wound size tended to be larger in the plerixafor group for the entire duration of observation. No significant difference was noted for the change in TcO 2 and ABI or in amputation rates. No other safety concern emerged. In conclusion, successful HSPC mobilization with plerixafor did not improve healing of ischemic diabetic wounds. Contrary to what was expected, outside the context of hematological disorders, mobilization of diabetic HSPCs might exert adverse effects on wound healing.",2020,No significant difference was noted for the change in TcO 2 and ABI or in amputation rates.,"['Twenty-six patients were enrolled: 13 received', 'diabetic ischemic wounds', 'Patients were 84.6% males, with a mean age of 69\u2009years', 'Patients with diabetes with ischemic wounds']","['CXCR4 antagonist plerixafor', 'plerixafor', 'plerixafor or saline', 'placebo']","['HSPC mobilization', 'healing rate', 'healing of ischemic diabetic wounds', 'rate of complete healing', 'Wound size', 'complete healing', 'change in TcO 2 and ABI or in amputation rates', 'wound size, transcutaneous oxygen tension (TcO 2 ), ankle-brachial index (ABI), amputations, and HSPC mobilization']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4761249', 'cui_str': 'Ischaemic wound'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C4728046', 'cui_str': 'Diabetic wound'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1863925', 'cui_str': 'Nonmedullary thyroid carcinoma, with or without cell oxyphilia'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}]",26.0,0.472383,No significant difference was noted for the change in TcO 2 and ABI or in amputation rates.,"[{'ForeName': 'Benedetta Maria', 'Initials': 'BM', 'LastName': 'Bonora', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Cappellari', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mazzucato', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Rigato', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Menegolo', 'Affiliation': 'Department of Cardiothoracic and Vascular Sciences, University of Padova, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruttocao', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Avogaro', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Gian Paolo', 'Initials': 'GP', 'LastName': 'Fadini', 'Affiliation': 'Department of Medicine, University of Padova, Padova, Italy.'}]",Stem cells translational medicine,['10.1002/sctm.20-0020']
3532,28715932,The Association of Socioeconomic Conditions and Readiness to Learn New Ways of Performing Daily Activities in Older Adults With Functional Difficulties.,"Behavioral interventions for older adults can reduce difficulties in performing daily activities, hospitalizations, and mortality risk. The success of behavior change interventions, however, can be affected by a participant's readiness to adopt changes. This study evaluates whether socioeconomic conditions, particularly financial strain affording food, are associated with readiness to change. We conducted a cross-sectional, descriptive study of baseline data from disabled older adults ( N = 147) participating in an intervention to reduce physical disability. Readiness to change score was rated at the start of the intervention by interventionists as either pre-action (precontemplation = 1, contemplation = 2, preparation = 3) or action (=4). Participants reporting high financial strain affording food were more likely to have high readiness at the start of intervention; the association of this specific socioeconomic condition with readiness may be an important consideration in implementing interventions to reduce disability.",2019,Participants reporting high financial strain affording food were more likely to have high readiness at the start of intervention; the association of this specific socioeconomic condition with readiness may be an important consideration in implementing interventions to reduce disability.,"['disabled older adults ( N = 147) participating in an intervention to reduce physical disability', 'older adults', 'Older Adults With Functional Difficulties']",['Behavioral interventions'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]",[],147.0,0.0165898,Participants reporting high financial strain affording food were more likely to have high readiness at the start of intervention; the association of this specific socioeconomic condition with readiness may be an important consideration in implementing interventions to reduce disability.,"[{'ForeName': 'Kelly T', 'Initials': 'KT', 'LastName': 'Gleason', 'Affiliation': '1 School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': '1 School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': '1 School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464817721110']
3533,29357757,Client reflections on confirmation and disconfirmation of expectations in cognitive behavioral therapy for generalized anxiety disorder with and without motivational interviewing.,"Objective: Addressing methodological shortcomings of prior work on process expectations, this study examined client process expectations both prospectively and retrospectively following treatment. Differences between clients receiving cognitive behavioral therapy (CBT) versus motivational interviewing integrated with CBT (MI-CBT) were also examined. Method : Grounded theory analysis was used to study narratives of 10 participants ( N = 5 CBT, 5 MI-CBT) who completed treatment for severe generalized anxiety disorder as part of a larger randomized controlled trial. Results: Clients in both groups reported and elaborated expectancy disconfirmations more than expectancy confirmations. Compared to CBT clients, MI-CBT clients reported experiencing greater agency in the treatment process than expected (e.g., that they did most of the work) and that therapy provided a corrective experience. Despite nearly all clients achieving recovery status, CBT clients described therapy as not working in some ways (i.e., tasks did not fit, lack of improvement) and that they overcame initial skepticism regarding treatment. Conclusions: Largely converging with MI theory, findings highlight the role of key therapist behaviors (e.g., encouraging client autonomy, validating) in facilitating client experiences of the self as an agentic individual who is actively engaged in the therapy process and capable of effecting change.",2019,Differences between clients receiving cognitive behavioral therapy (CBT) versus motivational interviewing integrated with CBT (MI-CBT) were also examined. ,"['generalized anxiety disorder with and without motivational interviewing', '10 participants ( N\u2009 =\u20095 CBT, 5 MI-CBT) who completed treatment for severe generalized anxiety disorder as part of a larger randomized controlled trial']","['cognitive behavioral therapy', 'cognitive behavioral therapy (CBT) versus motivational interviewing integrated with CBT (MI-CBT']",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",[],10.0,0.0112524,Differences between clients receiving cognitive behavioral therapy (CBT) versus motivational interviewing integrated with CBT (MI-CBT) were also examined. ,"[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Button', 'Affiliation': 'a Department of Psychology , York University , Toronto , ON , Canada.'}, {'ForeName': 'Nikoo', 'Initials': 'N', 'LastName': 'Norouzian', 'Affiliation': 'a Department of Psychology , York University , Toronto , ON , Canada.'}, {'ForeName': 'Henny A', 'Initials': 'HA', 'LastName': 'Westra', 'Affiliation': 'a Department of Psychology , York University , Toronto , ON , Canada.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'b Department of Psychology , University of Massachusetts Amherst , Amherst , MA , USA.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'c Department of Psychology , Ryerson University , Toronto , ON , Canada.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2018.1425932']
3534,32489146,ΔKi67 proliferation index as independent predictive and prognostic factor of outcome in luminal breast cancer: data from neoadjuvant letrozole-based treatment.,"A key tool for monitoring breast cancer patients under neoadjuvant treatment is the identification of reliable predictive markers. Ki67 has been identified as a prognostic and predictive marker in ER-positive breast cancer. Ninety ER-positive, HER2 negative locally advanced breast cancer patients received letrozole (2.5 mg daily) and cyclophosphamide (50 mg daily) with/without Sorafenib (400 mg/bid daily) for 6 months before undergoing surgery. Ki67 expression and tumor size measured with caliber were determined at baseline, after 30 days of treatment and at the end of treatment. Patients were assigned to a clinical response category according to Response Evaluation Criteria in Solid Tumors, both at 30 days and before surgery and further classified as high-responder and low-responder according to the median variation of Ki67 values between biopsy and 30 days and between biopsy and surgery time. The predictive role of Ki67 and its changes with regard to clinical response and survival was analyzed. No differences in terms of survival outcomes emerged between the arms of treatment, while we observed a higher percentage of women with progression or stable disease in arm with the combination containing Sorafenib (20.5% vs 7.1%, p = 0.06). Clinical complete responders experienced a greater overall variation in Ki67 when compared with partial responders and patients with progressive/stable disease (66.7% vs 30.7%, p = 0.009). High responders showed a better outcome than low responders in terms of both disease-free survival ( p = 0.009) and overall survival ( p = 0.002). ΔKi67 score evaluated between basal and residual tumor at definitive surgery showed to be highly predictive of clinical complete response, and a potential parameter to be used for predicting disease-free survival and overall survival in luminal breast cancer treated with neoadjuvant endocrine-based therapy.",2020,"Clinical complete responders experienced a greater overall variation in Ki67 when compared with partial responders and patients with progressive/stable disease (66.7% vs 30.7%, p = 0.009).","['luminal breast cancer', 'Ninety ER-positive, HER2 negative locally advanced breast cancer patients', 'monitoring breast cancer patients under']","['letrozole', 'cyclophosphamide', 'Sorafenib', 'neoadjuvant treatment']","['women with progression or stable disease', 'Ki67 expression and tumor size measured with caliber', 'overall survival', 'disease-free survival', 'survival outcomes']","[{'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0991705,"Clinical complete responders experienced a greater overall variation in Ki67 when compared with partial responders and patients with progressive/stable disease (66.7% vs 30.7%, p = 0.009).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ianza', 'Affiliation': 'Department of Medical, Surgery & Health Sciences, University of Trieste, Trieste, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Giudici', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pinello', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Corona', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Strina', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bernocchi', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bortul', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Milani', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sirico', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Allevi', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aguggini', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cocconi', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Azzini', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dester', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cervoni', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bottini', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cappelletti', 'Affiliation': 'Breast Cancer Unit and Translational Research Unit, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Generali', 'Affiliation': 'Department of Medical, Surgical & Health Sciences, Cattinara Teaching Hospital, University of Trieste, Trieste, Italy.'}]",Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine,['10.1177/1010428320925301']
3535,32489159,Sustained benefit of cognitive behaviour therapy for health anxiety in medical patients (CHAMP) over eight years: randomised controlled trial - CORRIGENDUM.,,2020,,['medical patients (CHAMP'],['cognitive behaviour therapy'],[],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0591994,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Tyrer', 'Affiliation': 'Centre for Mental Health, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Statistics, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': 'Centre for Mental Health, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dupont', 'Affiliation': 'Central Northwest London Foundation NHS Trust, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cooper', 'Affiliation': 'Centre for Mental Health, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nourmand', 'Affiliation': 'Centre for Mental Health, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lazarevic', 'Affiliation': 'Centre for Mental Health, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Philip', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tyrer', 'Affiliation': 'Centre for Mental Health, Faculty of Medicine, Imperial College, London, UK.'}]",Psychological medicine,['10.1017/S0033291720001932']
3536,32489239,"Effect of home-based Tai Chi, Yoga or conventional balance exercise on functional balance and mobility among persons with idiopathic Parkinson's disease: An experimental study.","Background
Individuals with Parkinson's disease (PD) invariably experience functional decline in a number of motor and non-motor domains affecting posture, balance and gait. Numerous clinical studies have examined effects of various types of exercise on motor and non-motor problems. But still much gap remains in our understanding of various therapies and their effect on delaying or slowing the dopamine neuron degeneration. Recently, Tai Chi and Yoga both have gained popularity as complementary therapies, since both have components for mind and body control.
Objective
The aim of this study was to determine whether eight weeks of home-based Tai Chi or Yoga was more effective than regular balance exercises on functional balance and mobility.
Methods
Twenty-seven individuals with Idiopathic PD (Modified Hoehn and Yahr stages 2.5-3) were randomly assigned to either Tai Chi, Yoga or Conventional exercise group. All the participants were evaluated for Functional Balance and Mobility using Berg Balance Scale, Timed 10 m Walk test and Timed Up and Go test before and after eight weeks of training.
Results
The results were analyzed using two-way mixed ANOVA which showed that there was a significant main effect for time as F (1, 24) = 74.18, p = 0 . 000 , η p 2 = 0 . 76 for overall balance in Berg Balance Scale. There was also significant main effect of time on mobility overall as F(1, 24) = 77 . 78 , p = 0 . 000 , η p 2 = 0 . 76 in Timed up and Go test and F(1, 24) = 48 . 24 , p = 0 . 000 , η p 2 = 0 . 67 for 10 m Walk test. There was a significant interaction effect for time × group with F(2, 24) = 8 . 67 , p = 0 . 001 , η p 2 = 0 . 420 for balance. With respect to mobility, the values F(2, 24) = 5 . 92 , p = 0 . 008 , η p 2 = 0 . 330 in Timed Up and Go test and F(2, 24) = 10 . 40 , p = 0 . 001 , η p 2 = 0 . 464 in 10 m Walk test showed a significant interaction. But there was no significant main effect between the groups for both balance and mobility.
Conclusion
The findings of this study suggest that Tai Chi as well as Yoga are well adhered and are attractive options for a home-based setting. As any form of physical activity is considered beneficial for individuals with PD either Tai Chi, Yoga or conventional balance exercises could be used as therapeutic intervention to optimize balance and mobility. Further studies are necessary to understand the mind-body benefits of Tai Chi and Yoga either as multicomponent physical activities or as individual therapies in various stages of PD.",2020,"But there was no significant main effect between the groups for both balance and mobility.
","['24 ', '92 ', '78 ', '008 ', ""persons with idiopathic Parkinson's disease"", '001 ', '000 ', 'Methods\n\n\nTwenty-seven individuals with Idiopathic PD (Modified Hoehn and Yahr stages 2.5-3', '67 ', ""\n\n\nIndividuals with Parkinson's disease (PD""]","['home-based Tai Chi, Yoga or conventional balance exercise', 'home-based Tai Chi or Yoga', 'regular balance exercises', 'Tai Chi, Yoga or Conventional exercise group']","['functional balance and mobility', 'Functional Balance and Mobility using Berg Balance Scale, Timed 10 m Walk test and Timed Up and Go test']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",27.0,0.0163333,"But there was no significant main effect between the groups for both balance and mobility.
","[{'ForeName': 'Arva', 'Initials': 'A', 'LastName': 'Khuzema', 'Affiliation': 'KMCH College of Physiotherapy, Avinashi Road, Coimbatore, Tamil Nadu, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brammatha', 'Affiliation': 'KMCH College of Physiotherapy, Avinashi Road, Coimbatore, Tamil Nadu, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Arul Selvan', 'Affiliation': 'Kovai Medical Centre and Hospital, Avinashi Road, Coimbatore, Tamil Nadu, India.'}]",Hong Kong physiotherapy journal : official publication of the Hong Kong Physiotherapy Association Limited = Wu li chih liao,['10.1142/S1013702520500055']
3537,32489241,"Pilot study on comparisons between the effectiveness of mobile video-guided and paper-based home exercise programs on improving exercise adherence, self-efficacy for exercise and functional outcomes of patients with stroke with 3-month follow-up: A single-blind randomized controlled trial.","Objective
To compare the effectiveness of mobile video-guided home exercise program and standard paper-based home exercise program.
Methods
Eligible participants were randomly assigned to either experimental group with mobile video-guided home exercise program or control group with home exercise program in a standard pamphlet for three months. The primary outcome was exercise adherence. The secondary outcomes were self-efficacy for exercise by Self-Efficacy for Exercise (SEE) Scale; and functional outcomes including mobility level by Modified Functional Ambulatory Category (MFAC) and basic activities of daily living (ADL) by Modified Barthel Index (MBI). All outcomes were captured by phone interviews at 1 day, 1 month and 3 months after the participants were discharged from the hospitals.
Results
A total of 56 participants were allocated to the experimental group ( n = 27 ) and control group ( n = 29 ) . There were a significant between-group differences in 3-months exercise adherence (experimental group: 75.6%; control group: 55.2%); significant between-group differences in 1-month SEE (experimental group: 58.4; control group: 43.3) and 3-month SEE (experimental group: 62.2; control group: 45.6). For functional outcomes, there were significant between-group differences in 3-month MFAC gain (experimental group: 1.7; control group: 1.0). There were no between-group differences in MBI gain.
Conclusion
The use of mobile video-guided home exercise program was superior to standard paper-based home exercise program in exercise adherence, SEE and mobility gain but not basic ADL gain for patients recovering from stroke.",2020,"The use of mobile video-guided home exercise program was superior to standard paper-based home exercise program in exercise adherence, SEE and mobility gain but not basic ADL gain for patients recovering from stroke.","['patients with stroke with 3-month follow-up', '56 participants', 'patients recovering from stroke']","['experimental group ( n = 27 ) and control group ( n = 29 ) ', 'mobile video-guided and paper-based home exercise programs', 'mobile video-guided home exercise program or control group with home exercise program', 'mobile video-guided home exercise program was superior to standard paper-based home exercise program in exercise adherence, SEE and mobility gain but not basic ADL gain', 'mobile video-guided home exercise program and standard paper-based home exercise program']","['exercise adherence, self-efficacy', '3-months exercise adherence', 'MBI gain', 'self-efficacy for exercise by Self-Efficacy for Exercise (SEE) Scale; and functional outcomes including mobility level by Modified Functional Ambulatory Category (MFAC) and basic activities of daily living (ADL) by Modified Barthel Index (MBI', 'exercise adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",56.0,0.0628893,"The use of mobile video-guided home exercise program was superior to standard paper-based home exercise program in exercise adherence, SEE and mobility gain but not basic ADL gain for patients recovering from stroke.","[{'ForeName': 'Bryan Ping Ho', 'Initials': 'BPH', 'LastName': 'Chung', 'Affiliation': 'Physiotherapy Department, Tai Po Hospital, 11 Chuen On Road, Tai Po, New Territories, Hong Kong.'}, {'ForeName': 'Wendy Kam Ha', 'Initials': 'WKH', 'LastName': 'Chiang', 'Affiliation': 'Physiotherapy Department, Shatin Hospital, 33A Kung Kok Street, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Lau', 'Affiliation': 'Hospital Chief Executive, Shatin Hospital, 33A Kung Kok Street, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Titanic Fuk On', 'Initials': 'TFO', 'LastName': 'Lau', 'Affiliation': 'Physiotherapy Department, Tai Po Hospital, 11 Chuen On Road, Tai Po, New Territories, Hong Kong.'}, {'ForeName': 'Charles Wai Kin', 'Initials': 'CWK', 'LastName': 'Lai', 'Affiliation': 'Physiotherapy Department, Shatin Hospital, 33A Kung Kok Street, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Claudia Sin Yi', 'Initials': 'CSY', 'LastName': 'Sit', 'Affiliation': 'Physiotherapy Department, Tai Po Hospital, 11 Chuen On Road, Tai Po, New Territories, Hong Kong.'}, {'ForeName': 'Ka Yan', 'Initials': 'KY', 'LastName': 'Chan', 'Affiliation': 'Physiotherapy Department, Shatin Hospital, 33A Kung Kok Street, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Chau Yee', 'Initials': 'CY', 'LastName': 'Yeung', 'Affiliation': 'Physiotherapy Department, Tai Po Hospital, 11 Chuen On Road, Tai Po, New Territories, Hong Kong.'}, {'ForeName': 'Tak Man', 'Initials': 'TM', 'LastName': 'Lo', 'Affiliation': 'Physiotherapy Department, Tai Po Hospital, 11 Chuen On Road, Tai Po, New Territories, Hong Kong.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Hui', 'Affiliation': 'Department of Medicine and Geriatrics, Shatin Hospital, 33A Kung Kok Street, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Jenny Shun Wah', 'Initials': 'JSW', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine and Geriatrics, Tai Po Hospital, 11 Chuen On Road, Tai Po, New Territories, Hong Kong.'}]",Hong Kong physiotherapy journal : official publication of the Hong Kong Physiotherapy Association Limited = Wu li chih liao,['10.1142/S1013702520500079']
3538,32489264,A randomized trial of the electronic Lung Cancer Symptom Scale for quality-of-life assessment in patients with advanced non-small-cell lung cancer.,"Introduction
Improving health-related quality of life (hrqol) is a key goal of systemic therapy in advanced lung cancer, although routine assessment remains challenging. We analyzed the impact of a real-time electronic hrqol tool, the electronic Lung Cancer Symptom Scale (elcss-ql), on palliative care (pc) referral rates, patterns of chemotherapy treatment, and use of other supportive interventions in patients with advanced non-small-cell lung cancer (nsclc) receiving first-line chemotherapy.
Methods
Patients with advanced nsclc starting first-line chemotherapy were randomized to their oncologist receiving or not receiving their elcss-ql data before each clinic visit. Patients completed the elcss-ql at baseline, before each chemotherapy cycle, and at subsequent follow-up visits until disease progression. Prospective data about the pc referral rate, hrqol, and use of other supportive interventions were collected.
Results
For the 95 patients with advanced nsclc who participated, oncologists received real-time elcss-ql data for 44 (elcss-ql arm) and standard clinical assessment alone for 51 (standard arm). The primary endpoint, the pc referral rate, was numerically higher, but statistically similar, for patients in the elcss-ql and standard arms. The hrqol scores over time were not significantly different between the two study arms.
Conclusions
The elcss-ql is feasible as a tool for use in routine clinical practice, although no statistically significant effect of its use was demonstrated in our study. Improving access to supportive care through the collection of patient-reported outcomes and hrqol should be an important component of care for patients with advanced lung cancer.",2020,"The elcss-ql is feasible as a tool for use in routine clinical practice, although no statistically significant effect of its use was demonstrated in our study.","['Patients with advanced nsclc starting first-line chemotherapy', '95 patients with advanced nsclc who participated, oncologists received real-time elcss-ql data for 44 (elcss-ql arm) and standard clinical assessment alone for 51 (standard arm', 'patients with advanced non-small-cell lung cancer', 'advanced lung cancer', 'patients with advanced non-small-cell lung cancer (nsclc) receiving first-line chemotherapy', 'patients with advanced lung cancer']",['electronic Lung Cancer Symptom Scale'],"['pc referral rate', 'hrqol scores over time', 'electronic Lung Cancer Symptom Scale (elcss-ql']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",95.0,0.106901,"The elcss-ql is feasible as a tool for use in routine clinical practice, although no statistically significant effect of its use was demonstrated in our study.","[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Kuo', 'Affiliation': 'Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Graham', 'Affiliation': 'Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salvarrey', 'Affiliation': 'Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kassam', 'Affiliation': 'Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON.'}, {'ForeName': 'L W', 'Initials': 'LW', 'LastName': 'Le', 'Affiliation': 'Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Burkes', 'Affiliation': 'Division of Medical Oncology, Mount Sinai Hospital, Toronto, ON.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Hollen', 'Affiliation': 'School of Nursing, University of Virginia, Charlottesville, VA, U.S.A.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Gralla', 'Affiliation': 'Albert Einstein College of Medicine, New York, NY, U.S.A.'}, {'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Leighl', 'Affiliation': 'Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON.'}]","Current oncology (Toronto, Ont.)",['10.3747/co.27.5651']
3539,32489296,"Effect of latanoprost on intraocular pressure, visual acuity and C-reactive protein.","Objective
To investigate the effect of latanoprost on intraocular pressure (IOP), visual acuity and C-reactive protein (CRP) in patients with primary open-angle glaucoma (POAG).
Methods
A total of 163 POAG patients (266 eyes) admitted to our hospital from February 2015 to July 2017 were selected and divided into observation group (81 cases, 132 eyes, latanoprost eye drops) and control group (82 cases, 134 eyes, timolol maleate eye drops) according to different treatment plans. The clinical efficacy of the two groups after treatment was evaluated. The IOP, visual acuity and CRP level were compared between the two groups before and after treatment. Then the adverse reactions of the two groups were observed and recorded.
Results
After treatment, the total effective rate was 92.59% (75 cases) in the observation group and was 80.49% (66 cases) in the control group, with statistic difference between groups ( P < 0.05); The IOP, visual acuity and CRP level between the two groups before treatment showed no statistic difference, the mentioned three indexes of the two groups were significantly improved after treatment, and statistic difference was found before and after treatment ( P < 0.05); Moreover, the above three indicators had statistically significant differences between groups after treatment ( P < 0.05); The difference of intraocular pressure and visual acuity between the two groups before and after treatment were statistically different ( P < 0.05); After treatment, the incidence of adverse reactions in the observation group such as allergy, vomiting, breathlessness and tachycardia were not significantly different from those in the control group ( P > 0.05).
Conclusion
Latanoprost can improve IOP, visual acuity, and CRP levels. It improves eye hemodynamics, and has significant efficacy in treating primary open-angle glaucoma. Also, it has good security.",2020,"After treatment, the total effective rate was 92.59% (75 cases) in the observation group and was 80.49% (66 cases) in the control group, with statistic difference between groups ( P < 0.05); The IOP, visual acuity and CRP level between the two groups before treatment showed no statistic difference, the mentioned three indexes of the two groups were significantly improved after treatment, and statistic difference was found before and after treatment ( P < 0.05);","['patients with primary open-angle glaucoma (POAG', '163 POAG patients (266 eyes) admitted to our hospital from February 2015 to July 2017 were selected and divided into observation group (81 cases, 132 eyes, latanoprost eye drops) and control group (82 cases, 134 eyes']","['latanoprost', 'Latanoprost', 'timolol maleate eye drops']","['total effective rate', 'clinical efficacy', 'intraocular pressure (IOP), visual acuity and C-reactive protein (CRP', 'incidence of adverse reactions', 'allergy, vomiting, breathlessness and tachycardia', 'eye hemodynamics', 'IOP, visual acuity and CRP level', 'adverse reactions', 'intraocular pressure, visual acuity and C-reactive protein', 'intraocular pressure and visual acuity', 'IOP, visual acuity, and CRP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517565', 'cui_str': '134'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",163.0,0.0535218,"After treatment, the total effective rate was 92.59% (75 cases) in the observation group and was 80.49% (66 cases) in the control group, with statistic difference between groups ( P < 0.05); The IOP, visual acuity and CRP level between the two groups before treatment showed no statistic difference, the mentioned three indexes of the two groups were significantly improved after treatment, and statistic difference was found before and after treatment ( P < 0.05);","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Hou', 'Affiliation': 'Department of Surgical Retina, Jinhua Eye Hospital, Jinhua 231000, Zhejiang, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""Department of Ophthalmology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai 200072, China.""}, {'ForeName': 'Qianjun', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Surgical Retina, Jinhua Eye Hospital, Jinhua 231000, Zhejiang, China.'}, {'ForeName': 'Famang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Glaucoma, Jinhua Eye Hospital, Jinhua 231000, Zhejiang, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Department of Glaucoma, Jinhua Eye Hospital, Jinhua 231000, Zhejiang, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2020.03.013']
3540,32489674,A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up.,"Background
Very few of the publicly available apps directed towards self-management of low back pain (LBP) have been rigorously tested and their theoretical underpinnings seldom described. The selfBACK app was developed in collaboration with end-users and clinicians and its content is supported by best evidence on self-management of LBP. The objectives of this pilot study were to investigate the basis for recruitment and screening procedures for the subsequent randomized controlled trial (RCT), to test the inclusion process in relation to questionnaires and app installation, and finally to investigate the change in primary outcome over time.
Methods
This single-armed pilot study enrolled 51 participants who had sought help for LBP of any duration from primary care (physiotherapy, chiropractic, or general practice) within the past 8 weeks. Participants were screened for eligibility using the PROMIS-Physical-Function-4a questionnaire. Participants were asked to use the selfBACK app for 6 weeks. The app provided weekly tailored self-management plans targeting physical activity, strength and flexibility exercises, and education. The construction of the self-management plans was achieved using case-based reasoning (CBR) methodology to capture and reuse information from previous successful cases. Participants completed the primary outcome pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at baseline and 6-week follow-up along with a range of secondary outcomes. Metrics of app use were collected throughout the intervention period.
Results
Follow-up data at 6 weeks was obtained for 43 participants. The recruitment procedures were feasible, and the number needed to screen was acceptable (i.e., 1.6:1). The screening questionnaire was altered during the pilot study. The inclusion process, answering questionnaires and app installation, were feasible. The primary outcome (RMDQ) improved from 8.6 (SD 5.1) at baseline to 5.9 (SD 4.0) at 6-week follow-up (change score 1.8, 95% CI 0.7 to 2.9). Participants spent on average 134 min (range 0-889 min) using the app during the 6-week period.
Conclusion
The recruitment, screening, and inclusion procedures were feasible for the subsequent RCT with a small adjustment. The improvement on the RMDQ from baseline to follow-up was small. Time pattern of app usage varied considerably between the participants.
Trial registration
NCT03697759. Registered on August 10, 2018. https://clinicaltrials.gov/ct2/show/NCT03697759.",2020,Participants completed the primary outcome pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at baseline and 6-week follow-up along with a range of secondary outcomes.,"['low back pain', '51 participants who had sought help for LBP of any duration from primary care (physiotherapy, chiropractic, or general practice) within the past 8\u2009weeks']",['digital decision support system (selfBACK'],"['pain-related disability (Roland-Morris Disability Questionnaire [RMDQ', 'RMDQ']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",51.0,0.143426,Participants completed the primary outcome pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at baseline and 6-week follow-up along with a range of secondary outcomes.,"[{'ForeName': 'Louise Fleng', 'Initials': 'LF', 'LastName': 'Sandal', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, University of Southern Denmark (UoSD), Odense, Denmark.'}, {'ForeName': 'Cecilie K', 'Initials': 'CK', 'LastName': 'Øverås', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, University of Southern Denmark (UoSD), Odense, Denmark.'}, {'ForeName': 'Anne Lovise', 'Initials': 'AL', 'LastName': 'Nordstoga', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Wood', 'Affiliation': 'School of Medicine, Dentistry & Nursing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Bach', 'Affiliation': 'Department of Computer Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hartvigsen', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, University of Southern Denmark (UoSD), Odense, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Søgaard', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, University of Southern Denmark (UoSD), Odense, Denmark.'}, {'ForeName': 'Paul Jarle', 'Initials': 'PJ', 'LastName': 'Mork', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00604-2']
3541,32489675,Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults: a randomised feasibility study.,"Background
Low quality social relationships in older adults are strongly associated with feelings of loneliness. Physical activity interventions could reduce loneliness and improve psychological well-being, among other health benefits. The aim of this study was to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults at risk of loneliness.
Methods
The PAIL feasibility study was a 12-week randomized controlled feasibility trial (RCT) conducted in Birmingham, United Kingdom, from February 2018 to August 2018, and ran in two waves of data collection. Eligible participants were community-dwelling adults aged 60 years and older, sedentary (less than 20 min of moderate-to-vigorous PA (MVPA) a week), and at risk of loneliness. The intervention included once-weekly group walk and health education workshop up to 90 min per session in total, with a wait-listed (WL) control group. The primary feasibility outcomes were to estimate recruitment, retention rates and adherence to the intervention. Secondary outcome measures (not blinded assessment) were body mass index, blood pressure, physical activity and psychosocial variables. Process and outcome evaluations were conducted using focus groups interviews. The recruitment and retention progression criteria for the definitive large-scale RCT was set a-priori.
Results
Forty-eight participants were recruited over 4 months with a recruitment rate of 25% (48/195); 52% (25/48) met the inclusion criteria and 100% (25/25) were randomised into the intervention ( n = 12) and WL control groups ( n = 13). Participants were 25 older adults (mean (SD) 68.5(8.05) years), 14 (56%) female, and 18 (72%) white. At 12 weeks, 10/12 (83.3%) intervention and 10/13 (76.9%) control participants completed the final assessments. The average attendance rate was 58.3% for the intervention group (range 33.0%-75.0%) and 42.3% (range 23.1%-69.2%) among controls. The a priori recruitment and retention criteria for progression were not met. No serious adverse events occurred. The focus group results identified three themes which showed overall positive experiences of participation in PAIL in terms of (1) study design and intervention; (2) walking sessions; and (3) health education workshops.
Conclusions
The findings suggest that community-dwelling older adults at risk of loneliness found the intervention and measures acceptable and could safely participate. However, a more extensive and robust strategy would be needed to support adequate recruitment of lonely older adults and adherence into a definitive RCT.
Trial registration
Clinicaltrials.gov, NCT03458793.",2020,No serious adverse events occurred.,"['older adults', 'community-dwelling older adults at risk of loneliness', 'community-dwelling older adults', 'Eligible participants were community-dwelling adults aged 60\u2009years and older, sedentary (less than 20\u2009min of moderate-to-vigorous PA (MVPA) a week), and at risk of loneliness', 'Forty-eight participants were recruited over 4\u2009months with a recruitment rate of 25% (48/195); 52% (25/48) met the inclusion criteria and 100% (25/25', 'Participants were 25 older adults (mean (SD) 68.5(8.05) years), 14 (56%) female, and 18 (72%) white', 'Birmingham, United Kingdom, from February 2018 to August 2018, and ran in two waves of data collection']","['Physical activity interventions', 'Physical Activity Intervention', 'weekly group walk and health education workshop up to 90\u2009min per session in total, with a wait-listed (WL) control group']","['estimate recruitment, retention rates and adherence to the intervention', 'Loneliness (PAIL', 'overall positive experiences of participation in PAIL', 'average attendance rate', 'body mass index, blood pressure, physical activity and psychosocial variables']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",48.0,0.0534405,No serious adverse events occurred.,"[{'ForeName': 'Anastasia V', 'Initials': 'AV', 'LastName': 'Shvedko', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Janice L', 'Initials': 'JL', 'LastName': 'Thompson', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Greig', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Whittaker', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00587-0']
3542,32489807,Very Early Versus Early Percutaneous Coronary Intervention in Patients with Decreased e-GFR after Successful Fibrinolytic Therapy.,"Background
Pharmacoinvasive strategy (PIS) is the alternative approach to primary percutaneous coronary intervention (PCI) if PCI capable center isn't available especially in the developing countries. Our objective of the current study was to investigate the incidence of contrast induced nephropathy (CIN), the occurrence of no reflow phenomenon and major adverse cardiac events (MACE) in patients with decreased estimated glomerular filtration rate (e-GFR) after successful fibrinolytic therapy in order to assess the benefit from very early PCI strategy (within 3-12 hours) or early PCI strategy (within 12-24 hours).
Methods
This randomized clinical trial included 420 patients with STEMI. All participants were classified randomly into two groups according to the time of intervention; Group I patients were subjected to very early PCI (within 3-12 hours) and Group II patients were subjected to early PCI (within 12-24 hours) after receiving successful fibrinolytic therapy.
Results
The incidence of CIN in Group I was slightly higher than Group II (23 patients [10.7%] versus 19 patients [9.3%]) respectively, with no statistically significant difference between the two groups (P value = 0.625). The incidence of no-reflow phenomenon (TIMI 0-2 flow) after the procedure was higher in Group II, while TIMI 3 flow (normal flow) was significantly higher in Group I than Group II (184 [85.6%] vs. 153 [74.6%], respectively) with P value = 0.044. There was no statistically significant difference between the two groups regarding mortality and MACE.
Conclusion
The incidence of CIN was nearly equal in very early PCI (within 3-12 hours) versus early PCI (within 12-24 hours); however, the incidence of no-reflow phenomenon was significantly higher in patients subjected to early PCI (within 12-24 hours).",2020,"The incidence of no-reflow phenomenon (TIMI 0-2 flow) after the procedure was higher in Group II, while TIMI 3 flow (normal flow) was significantly higher in Group I than Group II (184 [85.6%] vs. 153 [74.6%], respectively) with P value = 0.044.","['patients with decreased estimated glomerular filtration rate (e-GFR) after successful', 'Patients with Decreased e-GFR after Successful Fibrinolytic Therapy', '420 patients with STEMI']","['fibrinolytic therapy', 'successful fibrinolytic therapy', '\n\n\nPharmacoinvasive strategy (PIS']","['mortality and MACE', 'incidence of CIN', 'incidence of no-reflow phenomenon (TIMI 0-2 flow', 'incidence of no-reflow phenomenon']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0232347', 'cui_str': 'No reflow vascular flow'}]",420.0,0.0315396,"The incidence of no-reflow phenomenon (TIMI 0-2 flow) after the procedure was higher in Group II, while TIMI 3 flow (normal flow) was significantly higher in Group I than Group II (184 [85.6%] vs. 153 [74.6%], respectively) with P value = 0.044.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Khalfallah', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medicine, Tanta University, EG.'}, {'ForeName': 'Randa', 'Initials': 'R', 'LastName': 'Abdelmageed', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medicine, Tanta University, EG.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Allaithy', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medicine, Tanta University, EG.'}]",Global heart,['10.5334/gh.794']
3543,32489861,Randomised control trial on the optimal duration of non-weight-bearing walking after hallux valgus surgery.,"Introduction
Hallux valgus surgery is one of the most commonly performed operations in Orthopaedics. Multiple surgical techniques have been described including arthrodesis, osteotomies and soft tissue procedures. The endoscopic-assisted distal soft tissue procedure is one of the minimally invasive surgical options with a good long-term outcome. The rehabilitation protocol for this soft tissue procedure consists of 6-weeks of non-weight bearing walking. This prolonged period of non-weight-bearing walking may ensure a good stabilization of the alignment but is difficult for the patient from a social-economical perspective. In addition, earlier mobilisation has other theoretical advantages including less atrophy and better range of motion. The objective of this trial is to investigate the effect of an earlier weight-bearing regime at 2-weeks post-surgery.
Methods
Randomised control trial of patients undergoing the endoscopic-assisted distal soft tissue procedure. Allocation and randomization of subjects were performed immediately after completion of surgery to avoid intra-operative biases. The control group underwent the usual protocol of 6-weeks of non-weight-bearing walking while the intervention group underwent 2-weeks of post-operative non-weight-bearing walking. Foot function was measured using the Foot and Ankle Outcome Score (FAOS) at the baseline, 12-week post-surgery and 26-weeks post-surgery. The hallux valgus angle, 1,2 inter-metatarsal angle and tibial sesamoid position were also measured during those time-points.
Results
A total of 51 participants completed the study, 29 in the control group and 22 in the early weight-bearing group. 1 patient form the early weight-bearing group was complicated with hallux varus requiring revision surgery. All the patients had significantly improved radiological angles and foot function in both the control and early weight-bearing group. At the 12-week time point, the radiological angles were the same for both groups but foot function was significantly better in the early weightbearing group.
Discussion
Early postoperative weight-bearing did not lead to pre-mature implant failures or increased recurrence rates. It actually resulted in fewer symptoms like stiffness, lessened pain, better performance in daily activities and a better quality of life.
Conclusion
Early weight-bearing walking at 2-week after distal soft tissue reconstruction of hallux valgus is not only safe, it may help accelerate the rehabilitation process and allow patients to return their usual life faster. The translational potential of this article: Being a clinical trial, our results are directly translatable to hallux valgus patients. The results of this study show that a shortened non-weight bearing duration after hallux valgus surgery improves foot function at 12 weeks while not affecting recurrence risks.",2020,"At the 12-week time point, the radiological angles were the same for both groups but foot function was significantly better in the early weightbearing group.
","['A total of 51 participants completed the study, 29 in the control group and 22 in the early weight-bearing group', 'hallux valgus patients', 'patients undergoing the endoscopic-assisted distal soft tissue procedure']","['endoscopic-assisted distal soft tissue procedure', 'usual protocol of 6-weeks of non-weight-bearing walking while the intervention group underwent 2-weeks of post-operative non-weight-bearing walking', 'non-weight-bearing walking after hallux valgus surgery', 'hallux varus requiring revision surgery']","['radiological angles and foot function', 'symptoms like stiffness, lessened pain, better performance in daily activities and a better quality of life', 'Foot and Ankle Outcome Score (FAOS', 'radiological angles', 'foot function', 'recurrence rates', 'Foot function']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0546297', 'cui_str': 'Varus deformity of great toe'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",51.0,0.0543523,"At the 12-week time point, the radiological angles were the same for both groups but foot function was significantly better in the early weightbearing group.
","[{'ForeName': 'Samuel K K', 'Initials': 'SKK', 'LastName': 'Ling', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, CUHK, Hong Kong.'}, {'ForeName': 'Yuen-Man', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, CUHK, Hong Kong.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics and Traumatology, North District Hospital, Hong Kong.'}, {'ForeName': 'Tun Hing', 'Initials': 'TH', 'LastName': 'Lui', 'Affiliation': 'Department of Orthopaedics and Traumatology, North District Hospital, Hong Kong.'}, {'ForeName': 'Patrick Shu-Hang', 'Initials': 'PS', 'LastName': 'Yung', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, CUHK, Hong Kong.'}]",Journal of orthopaedic translation,['10.1016/j.jot.2020.04.009']
3544,32489982,Effect of bupivacaine versus lidocaine local anesthesia on postoperative pain reduction in single-port access laparoscopic adnexal surgery using propensity score matching.,"Objective
The umbilicus is a single, painful incisional site on the abdomen during trans-umbilical single-port access laparoscopic surgery. Previously, we found that periumbilical lidocaine could reduce postoperative pain. This study aimed to compare the efficacy of bupivacaine and lidocaine in reducing pain.
Methods
We performed a retrospective analysis in a study group (Bupivacaine group, 100 patients who received periumbilical infiltration of bupivacaine before their incisional site repair completion) and control group (Lidocaine group, 100 patients who received lidocaine at their incisional site repair completion). We compared postoperative pain based on the numerical rating scale (NRS) between propensity score-matched Bupivacaine-treated (n=50) and Lidocaine-treated (n=50) patients.
Results
The postoperative pain scores based on the NRS were not significantly different between the 2 groups until 12 hours post-operation. However, 24 hours post-operation, the Bupivacaine group showed significantly lower pain than the Lidocaine group (24 hours, 1.76±1.07 vs. 2.53±1.11 NRS, P <0.001; 48 hours, 0.84±0.85 vs. 2.16±0.85 NRS, P <0.001).
Conclusion
Periumbilical infiltration of bupivacaine has a longer acting efficacy on reducing postoperative surgical pain than that of lidocaine.",2020,The postoperative pain scores based on the NRS were not significantly different between the 2 groups until 12 hours post-operation.,"['single-port access laparoscopic adnexal surgery using propensity score matching', '100 patients who received periumbilical infiltration of', 'at their incisional site repair completion', 'before their incisional site repair completion) and control group (Lidocaine group, 100 patients who received', 'n=50) patients']","['Bupivacaine', 'bupivacaine', 'bupivacaine and lidocaine', 'Lidocaine', 'periumbilical lidocaine', 'lidocaine', 'Lidocaine-treated', 'lidocaine local anesthesia']","['postoperative pain scores', 'postoperative surgical pain', 'postoperative pain', 'numerical rating scale (NRS', 'pain', 'postoperative pain reduction']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457792', 'cui_str': 'Periumbilical'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0457792', 'cui_str': 'Periumbilical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",100.0,0.122531,The postoperative pain scores based on the NRS were not significantly different between the 2 groups until 12 hours post-operation.,"[{'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Kyung Jin', 'Initials': 'KJ', 'LastName': 'Eoh', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Jung-Yun', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Eun Ji', 'Initials': 'EJ', 'LastName': 'Nam', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Sunghoon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Sang Wun', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Young Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}]",Obstetrics & gynecology science,['10.5468/ogs.2020.63.3.363']
3545,32489983,Effects of surface electrical stimulation during sitting on pelvic floor muscle function and sexual function in women with stress urinary incontinence.,"Objective
Dysfunction of the pelvic floor muscles (PFM) is associated with sexual dysfunction in women with stress urinary incontinence (SUI). The EasyK7 device was developed to stimulate the PFM by surface electrical stimulation during sitting (SESdS). We investigated the effects of SESdS on PFM function and sexual function in women with SUI.
Methods
Women with SUI were randomized into the SESdS and control groups. PFM function and sexual function were assessed using a perineometer and the pelvic organ prolapse-urinary incontinence sexual function questionnaire (PISQ), respectively. After 8 weeks, the groups were compared using either analysis of covariance with the baseline values as covariates or the paired Student's t -test.
Results
The final analysis included 16 subjects from each group. There were significant differences between the SESdS and control groups after the intervention, as well as within the SESdS group between the pre- and post-intervention measurements. The P -values for the differences in PFM measurements between the groups, and between the pre- and post- intervention measurements within the SESdS group, were 0.001 and 0.004 for power, 0.015 and 0.011 for strength, and 0.012 and 0.034 for endurance, respectively. In addition, in the PISQ, there were significant differences between the groups and between the pre- and post-intervention measurements within the SESdS group in the partner-related domain (between groups: P =0.003; within SESdS group: P =0.024) and total score (between groups: P <0.001; within SESdS group: P =0.001).
Conclusion
SESdS can improve PFM function and sexual function in women with SUI.Trial RegistrationClinical Research Information Service Identifier: KCT0003357.",2020,"There were significant differences between the SESdS and control groups after the intervention, as well as within the SESdS group between the pre- and post-intervention measurements.","['women with stress urinary incontinence (SUI', 'women with SUI', 'women with stress urinary incontinence', '16 subjects from each group', 'Methods\n\n\nWomen with SUI']","['surface electrical stimulation', 'pelvic floor muscles (PFM', 'SESdS']","['pelvic floor muscle function and sexual function', 'PFM measurements', 'pelvic organ prolapse-urinary incontinence sexual function questionnaire (PISQ', 'total score', 'PFM function and sexual function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",16.0,0.049822,"There were significant differences between the SESdS and control groups after the intervention, as well as within the SESdS group between the pre- and post-intervention measurements.","[{'ForeName': 'Ui-Jae', 'Initials': 'UJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical Therapy, Graduate School, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Oh-Yun', 'Initials': 'OY', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Laboratory of Kinetic Ergocise Based on Movement Analysis, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Min-Seok', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': ""Sophie-Marceau Women's Clinic, Daegu, Korea.""}]",Obstetrics & gynecology science,['10.5468/ogs.2020.63.3.370']
3546,32489985,The role of port site local anesthetic injection in laparoendoscopic single site surgery: a prospective randomized study.,"Objective
To investigate the role of port-site bupivacaine hydrochloride injection in laparoendoscopic single-site surgery (LESS) as a means of postoperative umbilical pain alleviation.
Methods
A total of 200 consecutive patients who underwent LESS from October 2018 to February 2019 were included in this randomized prospective case control study. The patients were alternatively assigned to either the study group (0.25% 10-mL bupivacaine hydrochloride injection at the 1.5-cm umbilical incision site after surgery) or the control group (no injection). All patients underwent surgery at the National Health Insurance Service Ilsan Hospital under the same operational setting by 3 board-certified gynecologists. Postoperative umbilical pain scores assessed using the visual analog scale were compared between the 2 groups as the primary outcome. Student's t -test, χ 2 test, and a linear mixed model were used for the statistical analysis. A P -value of <0.05 was considered to be statistically significant.
Results
The patients' age, body mass index, and menopausal status; type of surgery performed; and need for additional trocar insertion exhibited a significant difference between the bupivacaine injection and non-injection groups. After adjusting for various confounding variables, the postoperative umbilical pain scores measured at postoperative 2-3 hours, 6-10 hours, 1 day, and 3 days did not exhibit a significant difference between the 2 groups.
Conclusion
Port-site bupivacaine injection in LESS did not show any additive effect in alleviation of postoperative umbilical pain.",2020,"Conclusion
Port-site bupivacaine injection in LESS did not show any additive effect in alleviation of postoperative umbilical pain.","['All patients underwent surgery at the National Health Insurance Service Ilsan Hospital under the same operational setting by 3 board-certified gynecologists', '200 consecutive patients who underwent LESS from October 2018 to February 2019', 'laparoendoscopic single site surgery']","['laparoendoscopic single-site surgery (LESS', 'bupivacaine', 'port-site bupivacaine hydrochloride injection', 'bupivacaine hydrochloride injection', 'port site local anesthetic injection', 'control group (no injection']","['alleviation of postoperative umbilical pain', 'postoperative umbilical pain scores', 'Postoperative umbilical pain scores', 'visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0232504', 'cui_str': 'Umbilical pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",200.0,0.0642717,"Conclusion
Port-site bupivacaine injection in LESS did not show any additive effect in alleviation of postoperative umbilical pain.","[{'ForeName': 'Jong Wook', 'Initials': 'JW', 'LastName': 'Seo', 'Affiliation': 'Department of Obstetrics and Gynecology,National Health Insurance Service Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'In Ok', 'Initials': 'IO', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology,National Health Insurance Service Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Jung Cheol', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology,Yonsei University, Severance Hospital, Seoul, Korea.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Chung', 'Affiliation': 'Department of Obstetrics and Gynecology,National Health Insurance Service Ilsan Hospital, Goyang, Korea.'}]",Obstetrics & gynecology science,['10.5468/ogs.2020.63.3.387']
3547,32489997,"Comparing the effect of two health education methods, self-directed and support group learning on the quality of life and self-care in Iranian postmenopausal woman.","BACKGROUND
Women during menopause stages experience many symptoms, for which they lack enough knowledge to manage them. This study aimed to compare the effect of self-directed and support group health education on the quality of life (QOL (and self-care of postmenopausal women.
MATERIALS AND METHODS
This field trial study was carried out with three groups. One hundred and eight menopause women were selected through convenient sampling method based on the inclusion criteria from three comprehensive health centers. Health centers were randomly assigned to support ( n = 36), self-directed ( n = 36), and control groups ( n = 36). In the self-directed group, education was provided through educational package, and the control group received routine care from the health center. The support group received education through four group sessions by trained healthy volunteers. Data were collected by menopause-specific QOL and self-care standard questionnaire.
RESULTS
Immediately after the intervention, the mean scores of QOL in the self-directed group, support group, and control group were 41.82 ± 7.61, 40.31 ± 4.80, and 48.17 ± 8.45, respectively ( P < 0.05). In addition, the mean scores of self-care were significantly different between the self-directed (40.67 ± 7.36) and support (36.50 ± 3.36) groups compared to the control group (47.83 ± 8.47) ( P < 0.05). After 1 month from intervention, QOL scores in the self-directed group (40.67 ± 7.36), support group (36.50 ± 3.36), and control group (47.83 ± 8.47) were significantly different ( P < 0.05). In addition, the mean scores of self-care were 64 ± 6.79 and 65 ± 8.32 in the self-directed and support groups, respectively, compared to the control group (49.09 ± 9.43). Post hoc test (least significant difference) revealed higher effectiveness of the support group ( P < 0.001).
CONCLUSIONS
Results indicated QOL and self-care in menopause women in self-directed and support groups improved. However, the support group provided higher effectiveness. Therefore, we recommended paying more attention to the capabilities of healthy volunteers for the promotion of QOL in menopause women.",2020,"Post hoc test (least significant difference) revealed higher effectiveness of the support group ( P < 0.001).
","['Health centers', 'Iranian postmenopausal woman', 'healthy volunteers for the promotion of QOL in menopause women', 'postmenopausal women', 'One hundred and eight menopause women were selected through convenient sampling method based on the inclusion criteria from three comprehensive health centers']","['self-directed and support group health education', 'two health education methods, self-directed and support group learning', 'control group received routine care from the health center']","['QOL and self-care', 'quality of life and self-care', 'QOL scores', 'mean scores of QOL', 'mean scores of self-care', 'quality of life (QOL (and self-care']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",108.0,0.0397495,"Post hoc test (least significant difference) revealed higher effectiveness of the support group ( P < 0.001).
","[{'ForeName': 'Fatemeh Ahmadi', 'Initials': 'FA', 'LastName': 'Dastgerdi', 'Affiliation': 'Student Research Committee, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Zandiyeh', 'Affiliation': 'Department of Community Health Nursing, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Kohan', 'Affiliation': 'Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_484_19']
3548,32490353,Putative modulation of the gut microbiome by probiotics enhances preference for novelty in a preliminary double-blind placebo-controlled study in ferrets.,"Background
Increasing evidence suggests a causal relationship between the gut microbiome and psychiatric illnesses. In particular, autism spectrum disorder is associated with gastrointestinal symptoms and alterations in the gut microbiome. Administration of probiotics is a commonly used strategy by caregivers of people with neurodevelopmental illness. However, evidence for successful improvement in gut microbiome and (behavioral) symptoms has been lacking.
Results
Here, we use a novel ferret model of maternal immune activation to show that high-dose probiotic administration in a placebo-controlled study design causes changes in the gut microbiome in the form of a transient increase in the administered bacterial species. In contrast, we found no differences in baseline microbiome composition or changes induced by probiotic administration between animals exposed in utero to maternal immune activation and control animals. However, the relative presence of several bacterial species correlated with an increased preference for novelty (object and conspecific). Intriguingly, several of the hits in this screen are species that have previously emerged in the literature as being associated with autism and anxiety.
Conclusions
Together, our results suggest that high-dose probiotic interventions may be beneficial for the adjunct treatment of psychiatric illnesses. Placebo-controlled clinical trials in humans are urgently needed.",2020,"In contrast, we found no differences in baseline microbiome composition or changes induced by probiotic administration between animals exposed in utero to maternal immune activation and control animals.",['caregivers of people with neurodevelopmental illness'],"['probiotics', 'Placebo']",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.209566,"In contrast, we found no differences in baseline microbiome composition or changes induced by probiotic administration between animals exposed in utero to maternal immune activation and control animals.","[{'ForeName': 'Supritha', 'Initials': 'S', 'LastName': 'Dugyala', 'Affiliation': 'Department of Biology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Travis S', 'Initials': 'TS', 'LastName': 'Ptacek', 'Affiliation': 'UNC Neuroscience Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Simon', 'Affiliation': 'UNC Neuroscience Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'UNC Neuroscience Center, University of North Carolina, Chapel Hill, NC, USA.'}]",Animal microbiome,['10.1186/s42523-020-00030-y']
3549,32490551,Reply to HEP-20-0871 Letter to the Editors: Cilofexor in patients with non-alcoholic steatohepatitis (NASH): Is it really effective?,"We thank Drs. Jindal and Sarin for their correspondence regarding our study of the nonsteroidal FXR agonist cilofexor in NASH. The objective of this Phase 2a study was to obtain preliminary evidence regarding the safety, pharmacokinetics, pharmacodynamics, and efficacy of cilofexor, including dose response. Indeed, our observations informed the 48-week ATLAS trial of cilofexor as monotherapy and in combination with other compounds that includes histologic endpoints (NCT03449446). Although reductions in liver transaminases were not statistically significant, dose-dependent improvements in GGT and hepatic fat by MRI-PDFF occurred. The proportion of patients with a ≥30% reduction in PDFF at week 24 was 13% in the placebo group, 14% in the cilofexor 30 mg group (p=0.87), and 39% in the 100 mg group (p=0.011).",2020,"Although reductions in liver transaminases were not statistically significant, dose-dependent improvements in GGT and hepatic fat by MRI-PDFF occurred.",['patients with non-alcoholic steatohepatitis (NASH'],"['cilofexor', 'HEP-20-0871 Letter to the Editors: Cilofexor', 'placebo']","['safety, pharmacokinetics, pharmacodynamics, and efficacy', 'GGT and hepatic fat by MRI-PDFF', 'PDFF', 'liver transaminases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C4761214', 'cui_str': 'Magnetic resonance proton density fat fraction measurement'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}]",,0.0432589,"Although reductions in liver transaminases were not statistically significant, dose-dependent improvements in GGT and hepatic fat by MRI-PDFF occurred.","[{'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Chuhan', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31402']
3550,32490570,Safety and Feasibility of Additional Tumor Debulking to First-Line Palliative Combination Chemotherapy for Patients with Multiorgan Metastatic Colorectal Cancer.,"INTRODUCTION
Local treatment of metastases is frequently performed in patients with multiorgan metastatic colorectal carcinoma (mCRC) analogous to selected patients with oligometastatic disease for whom this is standard of care. The ORCHESTRA trial (NCT01792934) was designed to prospectively evaluate overall survival benefit from tumor debulking in addition to chemotherapy in patients with multiorgan mCRC. Here, we report the preplanned safety and feasibility evaluation after inclusion of the first 100 patients.
METHODS
Patients were eligible if at least 80% tumor debulking was deemed feasible by resection, radiotherapy and/or thermal ablative therapy. In case of clinical benefit after three or four cycles of respectively 5-fluorouracil/leucovorin or capecitabine and oxaliplatin ± bevacizumab patients were randomized to tumor debulking followed by chemotherapy in the intervention arm, or standard treatment with chemotherapy.
RESULTS
Twelve patients dropped out prior to randomization for various reasons. Eighty-eight patients were randomized to the standard (n = 43) or intervention arm (n = 45). No patients withdrew after randomization. Debulking was performed in 82% (n = 37). Two patients had no lesions left to treat, five had progressive disease, and one patient died prior to local treatment. In 15 patients (40%) 21 serious adverse events related to debulking were reported. Postoperative mortality was 2.7% (n = 1). After debulking chemotherapy was resumed in 89% of patients.
CONCLUSION
Tumor debulking is feasible and does not prohibit administration of palliative chemotherapy in the majority of patients with multiorgan mCRC, despite the occurrence of serious adverse events related to local treatment.
IMPLICATIONS FOR PRACTICE
This first prospective randomized trial on tumor debulking in addition to chemotherapy shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment. The trial continues accrual and overall survival (OS) data and quality of life assessment are collected to determine whether the primary aim of >6 months OS benefit with preserved quality of life will be met. This will support evidence-based decision making in multidisciplinary colorectal cancer care and can be readily implemented in daily practice.",2020,"shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment.","['patients with multiorgan metastatic colorectal cancer', 'Patients were eligible if at least 80% tumor debulking was deemed feasible by resection', 'patients with multiorgan mCRC', '100 patients', 'Eighty-eight patients', 'patients with multiorgan metastatic colorectal carcinoma (mCRC', 'Patients with Multiorgan Metastatic Colorectal Cancer']","['chemotherapy', 'radiotherapy and/or thermal ablative therapy', 'Additional Tumor Debulking to First-Line Palliative Combination Chemotherapy', '5-fluorouracil/leucovorin or capecitabine and oxaliplatin ± bevacizumab']","['overall survival (OS) data and quality of life assessment', 'Postoperative mortality', 'overall survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",88.0,0.0760622,"shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment.","[{'ForeName': 'Elske C', 'Initials': 'EC', 'LastName': 'Gootjes', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'van der Stok', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Tineke E', 'Initials': 'TE', 'LastName': 'Buffart', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Bakkerus', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Labots', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Zonderhuis', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn R', 'Initials': 'MR', 'LastName': 'Meijerink', 'Affiliation': 'Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Haasbeek', 'Affiliation': 'Department of Radiotherapy, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jan-Willem B', 'Initials': 'JB', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, Isala, The Netherlands.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van Meerten', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Joost J M E', 'Initials': 'JJME', 'LastName': 'Nuyttens', 'Affiliation': 'Department of Radiotherapy, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Grunhagen', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0693']
3551,32490621,[Antiresorptive-cytokine effects of the chondroprotective therapy in patients with lower back pain].,"OBJECTIVE
To evaluate the antiresorptive-cytokine effects of chondroitin sulfate on non-specific lower back pain in patients with knee osteoarthritis (OA).
MATERIALS AND METHODS
Using the envelope method, 231 patients were randomized into two groups: group 1 ( n =116, main) received nonsteroidal anti-inflammatory drugs (NSAIDs) and chondrogard, group 2 ( n =115, comparison) received only NSAIDs. The 2-month study included 3 visits (V): V 1 - at the beginning of the study, V 2 - after 10 days, V 3 - after 60 days with the assessment of blood parameters: transforming growth factor β1 (TFR β1), interleukin (IL)-1β and IL-6, beta-Crosslaps, bone matrix formation indicator P1NP (n-terminal propeptide procollagen type 1), and determination of the level of deoxypyridinoline (DPID) in the urine.
RESULTS AND CONCLUSION
At the end of the study, there is a significant decrease in all studied cytokines in patients of group 1 compared to group 2, as well as indicators of beta-Crosslaps ( p <0,001) and DPID ( p <0,001), which may indicate the presence of its own antiresorptive-cytokine effect in chondroitin sulfate.",2020,"At the end of the study, there is a significant decrease in all studied cytokines in patients of group 1 compared to group 2, as well as indicators of beta-Crosslaps ( p <0,001) and DPID ( p <0,001), which may indicate the presence of its own antiresorptive-cytokine effect in chondroitin sulfate.","['patients with knee osteoarthritis (OA', 'patients with lower back pain', '231 patients']","['chondroprotective therapy', 'chondroitin sulfate', 'nonsteroidal anti-inflammatory drugs (NSAIDs) and chondrogard, group 2 ( n =115, comparison) received only NSAIDs']","['blood parameters: transforming growth factor β1 (TFR β1), interleukin (IL)-1β and IL-6, beta-Crosslaps, bone matrix formation indicator P1NP (n-terminal propeptide procollagen type 1), and determination of the level of deoxypyridinoline (DPID']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0108801', 'cui_str': 'TFRC protein, human'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4522215', 'cui_str': 'Beta-crosslaps'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0057455', 'cui_str': 'Deoxypyridinoline'}]",231.0,0.0452325,"At the end of the study, there is a significant decrease in all studied cytokines in patients of group 1 compared to group 2, as well as indicators of beta-Crosslaps ( p <0,001) and DPID ( p <0,001), which may indicate the presence of its own antiresorptive-cytokine effect in chondroitin sulfate.","[{'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Zolotovskaya', 'Affiliation': 'Samara State Medical University, Samara, Russia.'}, {'ForeName': 'I L', 'Initials': 'IL', 'LastName': 'Davydkin', 'Affiliation': 'Samara State Medical University, Samara, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012004165']
3552,32490642,Baseline characteristics predicting clinical outcomes and serious adverse events in middle-aged hypertensive women: a sub-analysis of the SPRINT in women aged <65 years.,"BACKGROUND/AIM
The predictability of clinical outcomes in hypertension in specific patient groups, especially underrepresented populations is the key to rational treatment. This study aimed to investigate the impact of baseline characteristics of <65-year-old hypertensive women with an increased risk of cardiovascular events, managed with standard- or intensive-approach, on their clinical outcomes and serious adverse events (SAEs).
MATERIALS AND METHODS
Baseline characteristics of <65-year-old hypertensive women (n=1247) in SPRINT, a multicenter randomized trial to compare standard and intensive antihypertensive treatment, were analyzed with Cox-regression method to determine potential predictors of the clinical outcomes and SAEs. The primary outcome was the composite of myocardial infarction (MI), non-MI acute coronary syndrome, stroke, heart failure, or cardiovascular death.
RESULTS
The primary outcome occurred in 3.1% and SAEs in 27.6% of the population. The treatment groups were similar in terms of the primary outcome, SAEs, or their individual components. The primary outcome occurred significantly more in current-smokers vs. non-smokers (HR: 2.85, 95% CI: 1.34-6.09). The subjects who were on aspirin in the intensive-group were significantly more likely to develop the primary outcome (HR: 3.17, 95% CI: 1.23-8.19) and MI (HR: 10.15, 95% CI: 1.19-86.88) compared with those not using aspirin. The risk of overall SAEs was significantly higher in blacks vs. non-blacks (HR: 1.27, 95% CI: 1.01-1.58), in current-smokers vs. non-smokers (HR: 1.59, 95% CI: 1.23-2.05), and those with vs. without chronic kidney disease (CKD), (HR: 1.38, 95% CI: 1.08-1.77). The likelihood of SAEs significantly increased with age (HR: 1.04, 95% CI: 1.01-1.07).
CONCLUSION
Smoking, aspirin, CKD, black race, and age seemed as important baseline characteristics in follow-up of <65-year-old hypertensive women, also depending on therapeutic strategy. Clinicians are expected to consider these critical parameters for effective antihypertensive management that promotes better outcomes in this middle-aged female population.",2020,"The likelihood of SAEs significantly increased with age (HR: 1.04, 95% CI: 1.01-1.07).
","['65-year-old hypertensive women with an increased risk of cardiovascular events, managed with standard- or intensive-approach', 'middle-aged hypertensive women', 'women aged <65 years', '65-year-old hypertensive women', 'Baseline characteristics of <65-year-old hypertensive women ', 'middle-aged female population']",['aspirin'],"['SAEs, or their individual components', 'risk of overall SAEs', 'composite of myocardial infarction (MI), non-MI acute coronary syndrome, stroke, heart failure, or cardiovascular death', 'current-smokers vs. non-smokers', 'likelihood of SAEs']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.264691,"The likelihood of SAEs significantly increased with age (HR: 1.04, 95% CI: 1.01-1.07).
","[{'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Aydin', 'Affiliation': ''}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Akici', 'Affiliation': ''}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Sakarya', 'Affiliation': ''}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Akman', 'Affiliation': ''}, {'ForeName': 'Ali Serdar', 'Initials': 'AS', 'LastName': 'Fak', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-1907-144']
3553,32489970,"Comparing the effects of vaginal misoprostol, laminaria, and extra amniotic saline infusion on cervical ripening and induction of labor.","Objective
This study aimed to compare the effects of vaginal misoprostol, laminaria, and extra-amniotic saline infusion (EASI) on cervical ripening.
Methods
This randomized controlled trial was conducted on 195 women with singleton pregnancies and unripe cervices. Participants were randomly allocated to 3, 65-person groups: a misoprostol, a laminaria, and an EASI group. The interventions in the misoprostol, laminaria, and EASI groups included a single 25-µg vaginal misoprostol suppository, an intracervical laminaria, and a transcervical Foley catheter, respectively. The groups were compared with each other regarding time intervals from labor induction to labor active phase and delivery, cervical dilation, Bishop scores 6 hours after induction, delivery type, length of hospital stay, and complications.
Results
There were no significant differences among the groups regarding maternal ages, gestational ages, body mass indices, baseline cervical dilations, and Bishop scores ( P >0.05). Six hours after induction, the Bishop score and cervical dilation were significantly greater in the EASI group than in the other 2 groups ( P <0.001). Moreover, time intervals from labor induction to labor active phase and delivery in the EASI group were significantly short ( P <0.001). The rates of cesarean section, fetal distress, placental abruption, and meconium staining in the misoprostol group were significantly high ( P <0.05), and the length of hospital stay in the EASI group was significantly short ( P <0.001).
Conclusion
EASI is a safer and more effective method for cervical ripening. Considering its inexpensiveness, easy accessibility, and greater effectiveness, EASI is recommended for cervical ripening.
Trial Registration
Iranian Center for Clinical Trials Identifier: IRCT20170513033941N39.",2020,"There were no significant differences among the groups regarding maternal ages, gestational ages, body mass indices, baseline cervical dilations, and Bishop scores ( P >0.05).",['195 women with singleton pregnancies and unripe cervices'],"['EASI', 'misoprostol, a laminaria, and an EASI group', 'vaginal misoprostol, laminaria, and extra amniotic saline infusion', 'vaginal misoprostol, laminaria, and extra-amniotic saline infusion (EASI']","['maternal ages, gestational ages, body mass indices, baseline cervical dilations, and Bishop scores', 'length of hospital stay', 'Bishop score and cervical dilation', 'rates of cesarean section, fetal distress, placental abruption, and meconium staining', 'cervical ripening and induction of labor', 'time intervals from labor induction to labor active phase and delivery']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0457226', 'cui_str': 'Uneffaced cervix'}]","[{'cui': 'C0442084', 'cui_str': 'Extra-amniotic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0022980', 'cui_str': 'Laminaria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring fetal status'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0025047', 'cui_str': 'Meconium stool'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0600454', 'cui_str': 'Cervical Ripening'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",195.0,0.145907,"There were no significant differences among the groups regarding maternal ages, gestational ages, body mass indices, baseline cervical dilations, and Bishop scores ( P >0.05).","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Tabasi', 'Affiliation': 'Department of Obstetrics and Gynecology, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Mesdaghinia', 'Affiliation': 'Department of Obstetrics and Gynecology, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Abedzadeh-Kalahroudi', 'Affiliation': 'Trauma Nursing Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Sehat', 'Affiliation': 'Trauma Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Panahandeh', 'Affiliation': 'Department of Obstetrics and Gynecology, Kashan University of Medical Sciences, Kashan, Iran.'}]",Obstetrics & gynecology science,['10.5468/ogs.2020.63.3.261']
3554,32489975,Randomized controlled trial for improved recovery of the pelvic floor after vaginal delivery with a specially formulated postpartum supplement.,"Objective
To improve pelvic floor recovery after vaginal delivery with daily supplementation of a specially formulated postpartum recovery supplement.
Methods
Within 48 hours of vaginal delivery, primipara women were randomized in a 1:1 ratio to receive daily oral supplementation for 6 weeks with either a combination of regular prenatal vitamin (PNV), leucine (4 g/day), zinc (30 mg/day) and omega-3 fatty acid (900 mg/day) (treatment group), or only a PNV daily (control group). Co-primary outcomes were vaginal squeeze pressure as measured by perineometer and levator muscle injury as measured by transperineal 3-dimensional tomographic ultrasound at 6 weeks postpartum.
Results
Twenty-six women in the control group and 27 in the treatment group completed the trial. Weak pelvic floor muscle strength was significantly less frequent in the treatment group compared to the control group at 6 weeks after delivery (28% vs. 58%, P =0.03). Both right and left-sided levator-urethra gap was significantly larger in the control group compared to the treatment group indicating more levator injury being present in the control group at 6 weeks after delivery. Anterior vaginal wall prolapse at or beyond the hymenal ring was significantly more common in the control group compared to the treatment group (19% vs. 0%, P =0.02). Significantly more women reported bothersome bulge symptoms in the control group compared to the treatment group at 6 weeks postpartum (19% vs. 0%, P =0.02).
Conclusion
Postpartum women who received a specially formulated postpartum recovery supplement had improved recovery of the pelvic floor after vaginal delivery.",2020,"Weak pelvic floor muscle strength was significantly less frequent in the treatment group compared to the control group at 6 weeks after delivery (28% vs. 58%, P =0.03).","['Twenty-six women in the control group and 27 in the treatment group completed the trial', 'Within 48 hours of vaginal delivery, primipara women']","['regular prenatal vitamin (PNV), leucine (4 g/day), zinc (30 mg/day) and omega-3 fatty acid']","['bothersome bulge symptoms', 'recovery of the pelvic floor', 'Weak pelvic floor muscle strength', 'vaginal squeeze pressure', 'pelvic floor recovery', 'Anterior vaginal wall prolapse']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0425852', 'cui_str': 'Anterior vaginal wall prolapse'}]",,0.104243,"Weak pelvic floor muscle strength was significantly less frequent in the treatment group compared to the control group at 6 weeks after delivery (28% vs. 58%, P =0.03).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Takacs', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, USA.'}, {'ForeName': 'Bence', 'Initials': 'B', 'LastName': 'Kozma', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen Faculty of Medicine, Debrecen, Hungary.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Lampé', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen Faculty of Medicine, Debrecen, Hungary.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Sipos', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen Faculty of Medicine, Debrecen, Hungary.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Poka', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen Faculty of Medicine, Debrecen, Hungary.'}]",Obstetrics & gynecology science,['10.5468/ogs.2020.63.3.305']
3555,32489976,Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial.,"Objective
To compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D) in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D.
Methods
This was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who did not receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered 300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180 days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-D at days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positive ICT results at days 90 and 180 were compared between the groups using Fisher's exact test.
Results
A total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in the R-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D.
Conclusion
The studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic. Trial Registration: Clinical Trials Registry of India Identifier: Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/03/008101.",2020,"Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae.","['RhD-negative pregnant women who did not receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline', 'A total of 144 women']","['ICT', 'recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D', 'Recombinant anti-D']","['maternal-fetal rhesus D (RhD) alloimmunization', 'adverse events', 'positive ICT']","[{'cui': 'C0024400', 'cui_str': 'Macaca mulatta'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0140430', 'cui_str': 'Blood group antibody D'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0009961', 'cui_str': 'Coombs test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0140430', 'cui_str': 'Blood group antibody D'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0024400', 'cui_str': 'Macaca mulatta'}, {'cui': 'C0948201', 'cui_str': 'Alloimmunisation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",144.0,0.0995498,"Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae.","[{'ForeName': 'Rahul Vishwanath', 'Initials': 'RV', 'LastName': 'Mayekar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Mumbai, India.'}, {'ForeName': 'Gopalkrishna Vinayak', 'Initials': 'GV', 'LastName': 'Paradkar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital, Thane, India.'}, {'ForeName': 'Archana Anilkumar', 'Initials': 'AA', 'LastName': 'Bhosale', 'Affiliation': 'Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Mumbai, India.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Sachan', 'Affiliation': ""Department of Obstetrics and Gynaecology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'Sumalatha', 'Initials': 'S', 'LastName': 'Beeram', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gandhi Medical College and Hospital, Secunderabad, India.'}, {'ForeName': 'Ashok Ramachandra', 'Initials': 'AR', 'LastName': 'Anand', 'Affiliation': 'Department of Obstetrics and Gynaecology, Grant Medical College and Sir J.J. Group of Hospitals, Mumbai, India.'}, {'ForeName': 'Shuchita Ramesh', 'Initials': 'SR', 'LastName': 'Mundle', 'Affiliation': 'Department of Obstetrics and Gynaecology, Government Medical College and Hospital, Nagpur, India.'}, {'ForeName': 'Yamini', 'Initials': 'Y', 'LastName': 'Trivedi', 'Affiliation': 'Department of Obstetrics and Gynaecology, AMC MET Medical College and Sheth LG General Hospital, Ahmedabad, India.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Md', 'Affiliation': 'Department of Obstetrics and Gynaecology, Apollo BGS Hospital, Mysore, India.'}, {'ForeName': 'Kiran Pandharinath', 'Initials': 'KP', 'LastName': 'Patole', 'Affiliation': 'Department of Obstetrics and Gynaecology, Dr. Vasantrao Pawar Medical College and Research Centre, Nashik, India.'}, {'ForeName': 'Pradip Wamanrao', 'Initials': 'PW', 'LastName': 'Sambarey', 'Affiliation': 'Department of Obstetrics and Gynaecology, Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.'}, {'ForeName': 'Gautam Vinod', 'Initials': 'GV', 'LastName': 'Daftary', 'Affiliation': 'Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, India.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'John', 'Affiliation': 'Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, India.'}, {'ForeName': 'Ganesh Harishchandra', 'Initials': 'GH', 'LastName': 'Divekar', 'Affiliation': 'Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, India.'}]",Obstetrics & gynecology science,['10.5468/ogs.2020.63.3.315']
3556,32490142,Effect of a multicomponent exercise intervention on brain metabolism: A randomized controlled trial on Alzheimer's pathology (Dementia-MOVE).,"Background
Physical activity has shown a positive impact on aging and neurodegeneration and represents a possible treatment option in cognitive decline. However, its underlying mechanisms and influences on brain pathology remain unclear. Dementia-MOVE (Multi-Objective Validation of Exercise) is a randomized-controlled pilot trial, including 50 patients with amnestic cognitive impairment associated with Alzheimer's pathology, aiming to analyze the effect of physical activity and fitness on disease progression.
Methods
Dementia-MOVE is divided into two arms, of either an intervention comprising physical activity, for at least twice a week, combined with a psychoeducational program, or a sole psychoeducational program. Physical activity intervention includes a supervised and unsupervised multimodal concept combining resistance, endurance, coordinative, and aerobic training. The primary outcome is the change of brain metabolism due to physical interventional treatment. Besides metabolic magnetic resonance imaging (MRI) including sodium and phosphorus imaging, resting state functional MRI, T1-, T2-weighted and fluid-attenuated inversion recovery (FLAIR), as well as diffusion-weighted imaging (DWI) of the brain and whole-body fat MRI are performed before and after intervention, and will be compared in their sensitivity for the detection of intervention effects. We further assess cognitive performance, neuropsychiatric symptoms, quality of life, fitness, and sleep via questionnaires/interviews and/or fitness trackers, as well as microbiome, under the aspect of Alzheimer's pathology.
Discussion
The aim of Dementia-MOVE is to investigate the effect of a multimodal exercise program on Alzheimer's pathology under different aspects of the disease. In this context, one of the main aims is the comparison of different MRI methods regarding their responsiveness for the detection of alterations induced by physical activity. As an underlying goal, new treatment and diagnostic options, as well as the exploration of fitness effects on brain structure and metabolism within a whole-body perspective of Alzheimer's disease are envisaged.",2020,"Dementia-MOVE (Multi-Objective Validation of Exercise) is a randomized-controlled pilot trial, including 50 patients with amnestic cognitive impairment associated with Alzheimer's pathology, aiming to analyze the effect of physical activity and fitness on disease progression.
","[""Alzheimer's pathology (Dementia-MOVE"", ""50 patients with amnestic cognitive impairment associated with Alzheimer's pathology""]","['multicomponent exercise intervention', 'multimodal exercise program', 'Physical activity intervention includes a supervised and unsupervised multimodal concept combining resistance, endurance, coordinative, and aerobic training']","['brain metabolism', 'change of brain metabolism', ""cognitive performance, neuropsychiatric symptoms, quality of life, fitness, and sleep via questionnaires/interviews and/or fitness trackers, as well as microbiome, under the aspect of Alzheimer's pathology""]","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C3856555', 'cui_str': 'Fitness Trackers'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",50.0,0.0821544,"Dementia-MOVE (Multi-Objective Validation of Exercise) is a randomized-controlled pilot trial, including 50 patients with amnestic cognitive impairment associated with Alzheimer's pathology, aiming to analyze the effect of physical activity and fitness on disease progression.
","[{'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Haeger', 'Affiliation': 'Department of Neurology RWTH Aachen University Aachen Germany.'}, {'ForeName': 'Ana S', 'Initials': 'AS', 'LastName': 'Costa', 'Affiliation': 'Department of Neurology RWTH Aachen University Aachen Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Romanzetti', 'Affiliation': 'Department of Neurology RWTH Aachen University Aachen Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kilders', 'Affiliation': 'Department of Physiotherapy RWTH Aachen University Aachen Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Trautwein', 'Affiliation': 'Department of Gastroenterology RWTH Aachen University Aachen Germany.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Haberl', 'Affiliation': 'Department of Neurology RWTH Aachen University Aachen Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beulertz', 'Affiliation': 'Department of Neurology RWTH Aachen University Aachen Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hildebrand', 'Affiliation': 'Department of Orthopedic Trauma Surgery RWTH Aachen University Aachen Germany.'}, {'ForeName': 'Jörg B', 'Initials': 'JB', 'LastName': 'Schulz', 'Affiliation': 'Department of Neurology RWTH Aachen University Aachen Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Reetz', 'Affiliation': 'Department of Neurology RWTH Aachen University Aachen Germany.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12032']
3557,32490143,"Transcranial stimulation in frontotemporal dementia: A randomized, double-blind, sham-controlled trial.","Introduction
Frontotemporal dementia (FTD) is a progressive disease for which no curative treatment is currently available. We aimed to determine whether transcranial direct current stimulation (tDCS) can modulate intracortical connectivity and improve cognition in symptomatic FTD patients and presymptomatic FTD subjects.
Methods
We performed a double-blind, randomized, sham-controlled trial with anodal tDCS or sham stimulation over the left prefrontal cortex in 70 participants (15 presymptomatic and 55 symptomatic FTD).
Results
We observed a significant increase of intracortical connectivity (short interval intracortical inhibition and facilitation) and improvement in clinical scores and behavioral disturbances in both symptomatic FTD patients and presymptomatic carriers after real tDCS but not after sham stimulation.
Discussion
A 2-weeks' treatment with anodal left prefrontal tDCS improves symptoms and restores intracortical inhibitory and excitatory circuits in both symptomatic FTD patients and presymptomatic carriers. tDCS might represent a promising future therapeutic and rehabilitative approach in patients with FTD.",2020,"We observed a significant increase of intracortical connectivity (short interval intracortical inhibition and facilitation) and improvement in clinical scores and behavioral disturbances in both symptomatic FTD patients and presymptomatic carriers after real tDCS but not after sham stimulation.
","['70 participants (15 presymptomatic and 55 symptomatic FTD', 'symptomatic FTD patients and presymptomatic carriers', 'symptomatic FTD patients and presymptomatic FTD subjects', 'patients with FTD', 'frontotemporal dementia']","['transcranial direct current stimulation (tDCS', 'anodal left prefrontal tDCS', 'tDCS', 'anodal tDCS or sham stimulation', 'Transcranial stimulation']","['symptoms and restores intracortical inhibitory and excitatory circuits', 'intracortical connectivity (short interval intracortical inhibition and facilitation', 'clinical scores and behavioral disturbances']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0236642', 'cui_str': ""Pick's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",70.0,0.509235,"We observed a significant increase of intracortical connectivity (short interval intracortical inhibition and facilitation) and improvement in clinical scores and behavioral disturbances in both symptomatic FTD patients and presymptomatic carriers after real tDCS but not after sham stimulation.
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Benussi', 'Affiliation': 'Neurology Unit Department of Clinical and Experimental Sciences University of Brescia Brescia Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': ""Dell'Era"", 'Affiliation': 'Neurology Unit Department of Clinical and Experimental Sciences University of Brescia Brescia Italy.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Cosseddu', 'Affiliation': 'Neurology Unit Spedali Civili Hospital Brescia Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cantoni', 'Affiliation': 'Neurology Unit Department of Clinical and Experimental Sciences University of Brescia Brescia Italy.'}, {'ForeName': 'Maria Sofia', 'Initials': 'MS', 'LastName': 'Cotelli', 'Affiliation': 'Neurology Unit Valle Camonica Hospital Esine Brescia Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cotelli', 'Affiliation': 'Neuropsychology Unit IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli Brescia Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Manenti', 'Affiliation': 'Neuropsychology Unit IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli Brescia Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Benussi', 'Affiliation': 'Molecular Markers Laboratory IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli Brescia Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Brattini', 'Affiliation': 'Neurology Unit Department of Clinical and Experimental Sciences University of Brescia Brescia Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Alberici', 'Affiliation': 'Neurology Unit Spedali Civili Hospital Brescia Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Borroni', 'Affiliation': 'Neurology Unit Department of Clinical and Experimental Sciences University of Brescia Brescia Italy.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12033']
3558,32490164,Using computerized assessment in simulated colonoscopy: a validation study.,"Background and study aims Patient safety during a colonoscopy highly depends on endoscopist competence. Endoscopic societies have been calling for an objective and regular assessment of the endoscopists, but existing assessment tools are time-consuming and prone to bias. We aimed to develop and gather evidence of validity for a computerized assessment tool delivering automatic and unbiased assessment of colonoscopy based on 3 dimensional coordinates from the colonoscope. Methods Twenty-four participants were recruited and divided into two groups based on experience: 12 experienced and 12 novices. Participants performed twice on a physical phantom model with a standardized alpha loop in the sigmoid colon. Data was gathered directly from the Olympus ScopeGuide system providing XYZ-coordinates along the length of the colonoscope. Five different motor skill measures were developed based on the data, named: Travel Length, Tip Progression, Chase Efficiency, Shaft movement without tip progression, and Looping. Results The experinced had a lower travel length ( P < 0.001), tip progression ( P < 0.001), chase efficiency ( P = 0.001) and looping ( P = 0.006), and a higher shaft movement without tip progression ( P < 0.001) reaching the cecum compared with the novices. A composite score was developed based on the five measurements to create a combined score of progression, the 3D-Colonoscopy-Progression-Score (3D-CoPS). The 3D-CoPS revealed a significant difference between groups (experienced: 0.495 (SD 0.303) and novices -0.454 (SD 0.707), P < 0.001). Conclusion This study presents a novel, real-time computerized assessment tool for colonoscopy, and strong evidence of validity was gathered in a simulation-based setting. The system shows promising opportunities for automatic, unbiased and continuous assessment of colonoscopy performance.",2020,"The experinced had a lower travel length ( P < 0.001), tip progression ( P < 0.001), chase efficiency ( P = 0.001) and looping ( P = 0.006), and a higher shaft movement without tip progression ( P < 0.001) reaching the cecum compared with the novices.",['Methods\u2002 Twenty-four participants were recruited and divided into two groups based on experience: 12 experienced and 12 novices'],['physical phantom model with a standardized alpha loop'],"['tip progression', 'chase efficiency', 'lower travel length', 'Travel Length, Tip Progression, Chase Efficiency, Shaft movement without tip progression, and Looping']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0445022', 'cui_str': 'Loop'}]","[{'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0337141', 'cui_str': 'Shaft'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0445022', 'cui_str': 'Loop'}]",24.0,0.0426293,"The experinced had a lower travel length ( P < 0.001), tip progression ( P < 0.001), chase efficiency ( P = 0.001) and looping ( P = 0.006), and a higher shaft movement without tip progression ( P < 0.001) reaching the cecum compared with the novices.","[{'ForeName': 'Andreas Slot', 'Initials': 'AS', 'LastName': 'Vilmann', 'Affiliation': 'Rigshospitalet - CAMES, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lachenmeier', 'Affiliation': 'Rigshospitalet - CAMES, Copenhagen, Denmark.'}, {'ForeName': 'Morten Bo Søndergaard', 'Initials': 'MBS', 'LastName': 'Svendsen', 'Affiliation': 'Rigshospitalet - CAMES, Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Søndergaard', 'Affiliation': 'University Hospital Hvidovre, Department of Gastroenterology and Gastrointestinal Surgery, Copenhagen, Denmark.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'University of Illinois at Chicago, Department of Medical Education, Chicago, Illinois, United States.'}, {'ForeName': 'Lars Bo', 'Initials': 'LB', 'LastName': 'Svendsen', 'Affiliation': 'Rigshospitalet - Surgical Gastroenterology, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Konge', 'Affiliation': 'Rigshospitalet - CAMES, Copenhagen, Denmark.'}]",Endoscopy international open,['10.1055/a-1132-5259']
3559,32490266,Effect of student's empowerment program on brucellosis prevention: an application of extended health belief model.,"Background
To determine the effect of student's empowerment program using the extended health belief model on the brucellosis prevention in rural high school in Divandarreh, Kurdistan province, Iran.
Materials and methods
Quasi-experimental study with repeated measure (pre-test, post-test and at 2-month follow-up). In all 220 rural high school students were selected using a cluster sampling method. The data collection tool was a questionnaire based on the Health Belief Model (HBM). Five 1.5 hours sessions using lecture, group discussion, inquiry method, leaflet delivery, and the use of slides with Overhead projector and PowerPoints slide show, designed according to the Systematic Comprehensive Health Education and Promotion Model (SHEP), was presented for intervention group twice a week in schools. Data were analyzed by SPSS 18, using descriptive statistics as well as Chi-square, independent t-test and repeated measures at a significant level less than 0.05.
Results
The total mean age of participants was 14.6 ± 2.3. The intervention and control groups had no significant differences in terms of age, gender, and other demographic variables. There was no significant differences in the intervention and control groups before the intervention in terms of awareness, severity, benefits, barriers and self-efficacy. After educational program scores of awareness, severity, susceptibility, benefits, barriers and self-efficacy, and performance were higher in the intervention group compared to the control group.
Conclusion
Overall, implementation of the educational intervention based on theories and models had good effects on people that are in the risk of infection and zoonotic disease.",2020,"There was no significant differences in the intervention and control groups before the intervention in terms of awareness, severity, benefits, barriers and self-efficacy.","['220 rural high school students', 'rural high school in Divandarreh, Kurdistan province, Iran']","[""student's empowerment program"", 'slides with Overhead projector and PowerPoints slide show, designed according to the Systematic Comprehensive Health Education and Promotion Model (SHEP']","['awareness, severity, benefits, barriers and self-efficacy', 'awareness, severity, susceptibility, benefits, barriers and self-efficacy, and performance', 'brucellosis prevention']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C3856907', 'cui_str': 'Projector'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0006309', 'cui_str': 'Brucellosis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",220.0,0.0160253,"There was no significant differences in the intervention and control groups before the intervention in terms of awareness, severity, benefits, barriers and self-efficacy.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Karimyan', 'Affiliation': 'Environmental Health Research Center, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khezeli', 'Affiliation': 'Social Development and Health Promotion Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Latifi', 'Affiliation': 'Department of Public Health, Maragheh University of Medical Sciences, Maragheh, Iran.'}]",Journal of preventive medicine and hygiene,['10.15167/2421-4248/jpmh2020.61.1.1267']
3560,32490650,The effect of sacrospinous ligament fixation during vaginal hysterectomy on postoperative de-novo stress incontinence occurrence: A prospective study with two-year follow up.,"BACKGROUND/AIM
To investigate the risk of de novo stress urinary incontinence (SUI) occurrence in women who were treated for pelvic organ prolapse (POP) with sacrospinous ligament fixation (SSLF) in addition to vaginal hysterectomy (VAH) and antero-posterior colporrhaphy (CAP) over a 24 month follow up period.
MATERIALS AND METHODS
A prospective randomized study was designed. Women without occult or obvious SUI were randomized into either one of the study groups: Group1: VAH+CAP, and Group2: VAH+CAP+SSLF. Postoperatively, the patients were re-evaluated for de novo SUI occurrence.
RESULTS
A total of 150 women were analyzed [G1=VAH+CAP (n:77) and G2= VAH+CAP+SSLF (n:73)]. Mean age, parity, body mass index, menopausal status, and preoperative POP degree, grade 1 and grade 2-3 cystocele and rectocele frequencies were similar between the two groups. During follow-up period, de novo SUI developed in 7 patients (9.1%) of Group1, and in 6 patients (8.2%) of Group2 (p>0.05). In Groups 1 and 2, POP recurrence occurred in 5(6.4%) vs 1(1.3%) cases,respectively (p<0.05).
CONCLUSION
In patients undergoing surgery for POP, the addition of SSLF did not result in an increased rate of de novo SUI. Careful patient selection, and informing the patients about the risks and benefits of the planned surgical procedure are essential steps in each case of POP.",2020,"In patients undergoing surgery for POP, the addition of SSLF did not result in an increased rate of de novo SUI.","['Women without occult or obvious SUI', 'A total of 150 women were analyzed [G1=VAH+CAP (n:77) and G2= VAH+CAP+SSLF (n:73', 'women who were treated for pelvic organ prolapse (POP) with', 'patients undergoing surgery for POP']","['Group1: VAH+CAP, and Group2: VAH+CAP+SSLF', 'sacrospinous ligament fixation (SSLF', 'vaginal hysterectomy (VAH) and antero-posterior colporrhaphy (CAP', 'sacrospinous ligament fixation', 'vaginal hysterectomy']","['POP recurrence', 'Mean age, parity, body mass index, menopausal status, and preoperative POP degree, grade 1 and grade 2-3 cystocele and rectocele frequencies', 'postoperative de-novo stress incontinence occurrence', 'rate of de novo SUI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0195230', 'cui_str': 'Posterior repair of vagina'}, {'cui': 'C0009416', 'cui_str': 'Suture of vagina'}]","[{'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0010695', 'cui_str': 'Cystocele'}, {'cui': 'C0149771', 'cui_str': 'Herniation of rectum into vagina'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",150.0,0.0426981,"In patients undergoing surgery for POP, the addition of SSLF did not result in an increased rate of de novo SUI.","[{'ForeName': 'Eralp', 'Initials': 'E', 'LastName': 'Başer', 'Affiliation': ''}, {'ForeName': 'Kerem Doğa', 'Initials': 'KD', 'LastName': 'Seçkin', 'Affiliation': ''}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Kadiroğullari', 'Affiliation': ''}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Kiyak', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-2005-117']
3561,32490686,Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412.,"Current treatment guidelines for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) recommend multimodal treatment, including chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy. The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials. For patients with locally advanced disease, Phase Ib data on the use of pembrolizumab in combination with chemoradiation have shown the approach to be safe and feasible. We describe here the design and rationale for KEYNOTE-412, a randomized, double-blind, Phase III trial investigating pembrolizumab or placebo administered concurrently with CRT and as maintenance treatment in patients with locally advanced HNSCC. Clinical Trial Registration: NCT03040999 (ClinicalTrials.gov).",2020,The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials.,"['patients with locally advanced HNSCC', 'patients with locally advanced disease', 'patients with locally advanced head and neck squamous cell carcinoma (HNSCC', 'locally advanced head and neck squamous cell carcinoma']","['chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy', 'CRT', 'pembrolizumab', 'Pembrolizumab', 'pembrolizumab or placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.158035,The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials.,"[{'ForeName': 'Jean-Pascal', 'Initials': 'JP', 'LastName': 'Machiels', 'Affiliation': 'Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint-Luc & Institut de Recherche Clinique et Expérimentale, Université Catholique de Louvain (UCLouvain), Avenue Hippocrate 10, Brussels, Belgium.'}, {'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Campus, 114 Rue Edouard Vaillant, 94800, Villejuif, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Department of Medicine, Yale University School of Medicine & Yale Cancer Center, 333 Cedar Street, New Haven, CT 06510, USA.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Department of Head & Neck Medical Oncology, National Cancer Center Hospital East, 6-Chome-5-1 Kashiwanoha, Kashiwa, Chiba, 27-8577, Japan.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Department of Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori and\xa0University of Milan, Via Giacomo Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Waldron', 'Affiliation': 'Department of Radiation Oncology University of Toronto, Princess Margaret Cancer Centre, 610 University Avenue, Toronto, ON, M5G 2M9, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Simon', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital CHUV, Rue du Bugnon 21, 1011, Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gregoire', 'Affiliation': 'Department of Radiation Oncology, Centre Leon Berard, 28 Prom. Lea et Napoleon Bullukian, 69008, Lyon, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Harrington', 'Affiliation': 'Division of Radiotherapy & Imaging, The Institute of Cancer Research, London, SW3 6JB, UK.'}, {'ForeName': 'Gustavo Vasconcelos', 'Initials': 'GV', 'LastName': 'Alves', 'Affiliation': 'Centro Integardo de Pesquisa em Oncologia, Hospital Nossa Senhora da Conceição, Avenida Francisco Trein, 596 - Cristo Redentor Porto Alegre - RS, 91350-200, Brazil.'}, {'ForeName': 'Iane Pinto', 'Initials': 'IP', 'LastName': 'Figueiredo Lima', 'Affiliation': 'Crio Centro Regional Integrado de Oncologia, R. Francisco Calaca, 1300 - Alvaro Weyne, Fortaleza - CE, 60335-480, Brazil.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Department of Radiation Oncology, Institut Inter-Regional de Cancerologie-Centre Jean Bernard/Clinique Victor Hugo, 72000, Le Mans, France.'}, {'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'M Hughes', 'Affiliation': ""Cancer Care Services, Royal Brisbane & Women's Hospital, Butterfield Street, Herston QLD 4029, Australia & School of Medicine, University of Queensland, 20 Weightman Street, Herston, QLD, 4006, Australia.""}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Aksoy', 'Affiliation': 'Hacettepe University, Cancer Institute, Department of Medical Oncology, 06100, Ankara, Turkey.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Hetnal', 'Affiliation': 'Faculty of Medicine & Health Sciences, Andrzej Frycz Modrzewski Krakow University, Amethyst Radiotherapy Centre, Rydygier Hospital, Krakow, Poland, Złotej Jesieni 1, Krakow, Poland.'}, {'ForeName': 'Joy Y', 'Initials': 'JY', 'LastName': 'Ge', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Bidadi', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Lillian L', 'Initials': 'LL', 'LastName': 'Siu', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, Toronto, ON, M5G 2M9, Canada.'}]","Future oncology (London, England)",['10.2217/fon-2020-0184']
3562,32490758,Alliance-outcome relation and progress feedback: Secondary data analyses of a randomized clinical trial study in China.,"Objective : This study examined the alliance-outcome relation and the possible moderation effect of receiving progress feedback on a sample of Chinese clients. Method : One hundred and fifty-nine clients recruited from a university counseling center in central China filled out the Session Rating Scale (SRS) and the Outcome Rating Scale (ORS) each session. Participants were randomly assigned to either the progress feedback group or non-feedback group. Therapists working with clients in the feedback group received their clients' SRS and ORS scores weekly and were asked to plot their scores in a chart. The alliance-outcome and moderator effects were tested with disaggregated cross-lagged panel modeling of SRS and ORS. Results : The findings indicated a strong reciprocal relation between SRS and ORS, but the moderator effect due to feedback was not supported. Conclusion : Results affirm the cross-cultural stability of the session-by-session reciprocal effects of the alliance-outcome model in a Chinese sample. The issue of whether feedback moderates the within-person alliance-outcome relationship needs to be studied further.",2020,"The findings indicated a strong reciprocal relation between SRS and ORS, but the moderator effect due to feedback was not supported. ","['China', 'Chinese clients', 'One hundred and fifty-nine clients recruited from a university counseling center in central China filled out the']",['progress feedback group or non-feedback group'],['Session Rating Scale (SRS) and the Outcome Rating Scale (ORS) each session'],"[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4273502', 'cui_str': 'Session Rating Scale'}, {'cui': 'C4273786', 'cui_str': 'Outcome Rating Scale'}]",159.0,0.0536196,"The findings indicated a strong reciprocal relation between SRS and ORS, but the moderator effect due to feedback was not supported. ","[{'ForeName': 'Qiwu', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ""School of Psychology, Central China Normal University, Wuhan, People's Republic of China.""}, {'ForeName': 'Caizhi', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""School of Psychology, Central China Normal University, Wuhan, People's Republic of China.""}, {'ForeName': 'Chiachih D C', 'Initials': 'CDC', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, TX, USA.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': ""School of Psychology, Central China Normal University, Wuhan, People's Republic of China.""}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'She', 'Affiliation': ""School of Psychology, Central China Normal University, Wuhan, People's Republic of China.""}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Falkenström', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linkoping, Sweden.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1772517']
3563,32490771,The influence of local infiltration analgesia after total hip replacement. A randomized clinical trial.,"To determine whether local infiltration analgesia by catheter infusion was superior to conventional analgesia in terms of postoperative pain control after THR. A randomized double-blind clinical trial was performed. There were four groups based on catheter placement and the infusion constituents : 1) Intraarticular catheter + anesthetics ; 2) Intraarticular catheter +placebo ; 3) Subfascial catheter + anesthetics ; 4) Subfascial catheter + placebo. The anesthetic infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution was physiological serum. The same conventional analgesic schedule was prescribed to all patients. Pain was evaluated by means of PCA shots and the VAS. Side effects, time to start rehabilitation and time to discharge were also analyzed. 100 patients (25 for group). Mean age was 67 years old (SD 12 y/o) and 53% were male. Mean PCA shots was 27 [range 2-87] and mean VAS was 1 [range 0-7]. No differences were found (p>0.05) when these variables were compared between the groups. The use of LIA with bupivacaine using a catheter infusion does not provide better pain control after THR.",2020,No differences were found (p>0.05) when these variables were compared between the groups.,"['total hip replacement', '100 patients (25 for group', 'Mean age was 67 years old (SD 12 y/o) and 53% were male']","['LIA with bupivacaine', 'Intraarticular catheter + anesthetics ; 2) Intraarticular catheter +placebo ; 3) Subfascial catheter + anesthetics ; 4) Subfascial catheter + placebo', 'bupivacaine', 'placebo']","['mean VAS', 'pain control', 'Pain', 'Side effects, time to start rehabilitation and time to discharge', 'Mean PCA shots']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0580529', 'cui_str': 'Subfascial'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",100.0,0.211171,No differences were found (p>0.05) when these variables were compared between the groups.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cuenca-Llavall', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pérez-Prieto', 'Affiliation': ''}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Santiveri', 'Affiliation': ''}, {'ForeName': 'Alfonso León', 'Initials': 'AL', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Marqués', 'Affiliation': ''}]",Acta orthopaedica Belgica,[]
3564,31820289,"Randomized, Placebo-Controlled Trial of Targeting Neuroinflammation with Ibudilast to Treat Methamphetamine Use Disorder.","Methamphetamine (MA) triggers neuroinflammation and medications that counteract MA-induced neuroinflammation may reduce MA-induced neurodegeneration and improve neurocognition and treatment outcomes in MA use disorder. We performed a randomized, placebo-controlled trial to determine the safety and efficacy of ibudilast (IBUD), a phosphodiesterase inhibitor that reduces neuroinflammation, for the treatment of MA use disorder. Treatment-seeking volunteers with MA use disorder were randomly assigned to receive 12 weeks of IBUD 50 mg twice daily (N = 64) or placebo (N = 61) with medication management counseling. Participants visited the outpatient research clinic twice weekly to provide urine specimens for drug screens and undergo study assessments. The primary outcome was end of treatment MA-abstinence (EOTA) during weeks 11 and 12 of treatment. Serum IBUID levels were measured for IBUD participants during week 3 of treatment. There was no difference in EOTA for IBUD (14%) versus placebo (16%, p > 0.05). There was no correlation between serum IBUD levels and MA use during treatment and mean IBUD levels for participants with (mean = 51.3, SD = 20.3) and without (mean = 54.7, SD = 33.0, p = 0.70) EOTA. IBUD was well tolerated. IBUD did not facilitate MA abstinence in this outpatient trial. Whether targeting neuroinflammation, either with IBUD in other subgroups of MA users or clinical trial designs, or with other anti-inflammatory medications, is an effective strategy for treating MA use disorder is not clear. Graphical Abstract The proportion of urine drug screens negative for methamphetamine (MA) during the two week lead-in period (weeks -2 and - 1) and the 12 week medication treatment period (weeks 1-12) for ibudilast versus placebo.",2020,"There was no difference in EOTA for IBUD (14%) versus placebo (16%, p > 0.05).","['Treatment-seeking volunteers with MA use disorder', 'Participants visited the outpatient research clinic twice weekly to provide urine specimens for drug screens and undergo study assessments']","['Placebo', 'Graphical Abstract', 'Methamphetamine (MA', 'medication management counseling', 'ibudilast (IBUD', 'IBUD 50', 'placebo']","['EOTA for IBUD', 'tolerated', 'Serum IBUID levels', 'serum IBUD levels and MA use during treatment and mean IBUD levels', 'proportion of urine drug screens negative for methamphetamine (MA', 'treatment MA-abstinence (EOTA']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0038577', 'cui_str': 'Drug of abuse screen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0123047', 'cui_str': 'ibudilast'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0123047', 'cui_str': 'ibudilast'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0920168', 'cui_str': 'Urine drug screen negative'}]",,0.282391,"There was no difference in EOTA for IBUD (14%) versus placebo (16%, p > 0.05).","[{'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Heinzerling', 'Affiliation': 'Department of Family Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. kheinzerling@mednet.ucla.edu.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Briones', 'Affiliation': 'Department of Family Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'April D', 'Initials': 'AD', 'LastName': 'Thames', 'Affiliation': 'Department of Psychology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hinkin', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Tianle', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Statistics, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Ying Nian', 'Initials': 'YN', 'LastName': 'Wu', 'Affiliation': 'Department of Statistics, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Shoptaw', 'Affiliation': 'Department of Family Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]",Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology,['10.1007/s11481-019-09883-w']
3565,31829910,Diode Laser Vaporization for Benign Prostate Hyperplasia: Outcome After 126 Procedures.,"Purpose: Photoselective vaporization of the prostate (PVP) with a 940-nm diode laser is an option for treating symptoms caused by benign prostatic hyperplasia (BPH). Here, we present our experience using this technology. Methods: We prospectively evaluated 126 patients with lower urinary tract symptoms (LUTS) secondary to BPH who underwent PVP with a 940-nm diode laser from January 2011 to January 2014. The patients were assessed using the International Prostate Symptom Score (IPSS), quality of life (QoL) score, prostate-specific antigen (PSA) level, maximum urinary flow (Qmax) by uroflowmetry, postvoid residual volume, and prostate volume by ultrasound at baseline and 3, 6, 12, and 24 months after the procedure. Results: The average patient age was 68.8 ± 8.7 years (range 48-90 years), whereas the average preoperative parameters were as follows: IPSS, 26.1 ± 5.2; IPSS-QoL, 4.9 ± 0.8; Qmax, 4.5 ± 3.1 mL/s; prostate volume, 76.5 ± 35.5 mL; and PSA level, 3.9 ± 2.6 ng/mL. The average catheterization time was 24.7 ± 25.5 hours (range 3-120 hours), and the length of hospital stay was 22.4 ± 17.0 hours (range 8-144 hours). The mean follow-up duration was 17.9 months (range 1-36 months). All parameters showed significant improvement after 12 months. After 24 months, the IPSS (8.8 ± 5.4, p < 0.07), IPSS-QoL (1.6 ± 0.9, p < 0.13), Qmax (15.9 ± 7.3 mL/s, p < 0.11), and PSA level (1.2 ± 0.8 ng/mL, p < 0.11) were improved compared with the baseline, but the difference was not significant, probably due to the small number of patients evaluated in this period. No patients required a transfusion. Conclusions: The results suggest that PVP with a 940-nm diode laser is safe, effective, and durable for the treatment of LUTS secondary to BPH. The patients continue to be monitored for evaluation of the long-term results. A prospective randomized study would allow more solid conclusions regarding the technology to be reached.",2019,"After 24 months, the IPSS (8.8 ± 5.4, p < 0.07), IPSS-QoL (1.6 ± 0.9, p < 0.13), Qmax (15.9 ± 7.3 mL/s, p < 0.11), and PSA level (1.2 ± 0.8 ng/mL, p < 0.11) were improved compared with the baseline, but the difference was not significant, probably due to the small number of patients evaluated in this period.","['benign prostatic hyperplasia (BPH', 'The average patient age was 68.8\u2009±\u20098.7 years (range 48-90 years), whereas the average preoperative parameters were as follows', '126 patients with lower urinary tract symptoms (LUTS) secondary to BPH who underwent PVP with a 940-nm diode laser from January 2011 to January 2014', 'Benign Prostate Hyperplasia']","['Diode Laser Vaporization', 'Photoselective vaporization of the prostate (PVP', 'PVP', '940-nm diode laser']","['International Prostate Symptom Score (IPSS), quality of life (QoL) score, prostate-specific antigen (PSA) level, maximum urinary flow (Qmax) by uroflowmetry, postvoid residual volume, and prostate volume by ultrasound', 'PSA level', 'average catheterization time', 'length of hospital stay', 'IPSS', 'IPSS-QoL']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C4517905', 'cui_str': '940'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}]",126.0,0.0254412,"After 24 months, the IPSS (8.8 ± 5.4, p < 0.07), IPSS-QoL (1.6 ± 0.9, p < 0.13), Qmax (15.9 ± 7.3 mL/s, p < 0.11), and PSA level (1.2 ± 0.8 ng/mL, p < 0.11) were improved compared with the baseline, but the difference was not significant, probably due to the small number of patients evaluated in this period.","[{'ForeName': 'Eduardo Yukio', 'Initials': 'EY', 'LastName': 'Tanaka', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Frederico Teixeira', 'Initials': 'FT', 'LastName': 'Barbosa', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Claudio Bovolenta', 'Initials': 'CB', 'LastName': 'Murta', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Joaquim Francisco', 'Initials': 'JF', 'LastName': 'Claro', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Joao Padua', 'Initials': 'JP', 'LastName': 'Manzano', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}]",Journal of endourology,['10.1089/end.2019.0311']
3566,31992758,Maternal preconception lipid profile and gestational lipid changes in relation to birthweight outcomes.,"In 575 women with 1-2 prior pregnancy losses; total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) were evaluated preconception and throughout pregnancy to evaluate whether previously observed associations between third trimester maternal lipid profile and birthweight outcomes are driven by preconception lipids or lipid changes during pregnancy. Lipid trajectories were compared by pre-pregnancy body mass index (BMI) <25 or ≥25 kg/m 2 ; logistic regression models evaluated preconception lipid concentration and change from preconception to 28 weeks with adjusted odds of large- or small-for-gestational age (LGA or SGA) neonate by BMI group. Preconception lipid concentrations and gestational lipid trajectories varied by BMI group (P < 0.001). Preconception lipids were not associated with LGA or SGA in either group. A 10 mg/dL increase in HDL-C change from preconception to 28 weeks was associated with decreased odds of LGA (odds ratio (OR) = 0.63, 95% confidence interval (CI): 0.46, 0.86) and 10 mg/dL increase in TG change associated with increased odds of LGA (OR = 1.05, 95% CI: 1.01, 1.1) overall. For ≥25 BMI only, 10 mg/dL increase in HDL-C change was associated with decreased SGA odds (OR = 0.35, 95% CI: 0.19, 0.64). Gestational lipid trajectories differed by BMI group and were differentially associated with birthweight outcomes, with HDL-C more strongly associated with healthy birthweight in women with BMI ≥25.",2020,"Gestational lipid trajectories differed by BMI group and were differentially associated with birthweight outcomes, with HDL-C more strongly associated with healthy birthweight in women with BMI ≥25.",['575 women with 1-2 prior pregnancy losses; total'],[],"['HDL-C change', 'Gestational lipid trajectories', 'Lipid trajectories', 'pre-pregnancy body mass index (BMI', 'cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG', 'healthy birthweight', 'Maternal preconception lipid profile and gestational lipid changes', 'Preconception lipid concentrations and gestational lipid trajectories']","[{'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",575.0,0.0395867,"Gestational lipid trajectories differed by BMI group and were differentially associated with birthweight outcomes, with HDL-C more strongly associated with healthy birthweight in women with BMI ≥25.","[{'ForeName': 'Alaina M', 'Initials': 'AM', 'LastName': 'Bever', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gerlanc', 'Affiliation': 'The Prospective Group, 1655 Fort Myer Dr #700, Arlington, VA, 22209, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'DeVilbiss', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, 30 North 1900 East, Salt Lake City, UT, 84132, United States.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Amyx', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Levine', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Grantz', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, MSC 7004, Bethesda, MD, 20892, United States. katherine.grantz@nih.gov.'}]",Scientific reports,['10.1038/s41598-019-57373-z']
3567,32484754,Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial.,"PURPOSE
The oligometastatic paradigm hypothesizes that patients with a limited number of metastases may achieve long-term disease control, or even cure, if all sites of disease can be ablated. However, long-term randomized data that test this paradigm are lacking.
METHODS
We enrolled patients with a controlled primary malignancy and 1-5 metastatic lesions, with all metastases amenable to stereotactic ablative radiotherapy (SABR). We stratified by the number of metastases (1-3 v 4-5) and randomized in a 1:2 ratio between palliative standard-of-care (SOC) treatments (arm 1) and SOC plus SABR (arm 2). We used a randomized phase II screening design with a primary end point of overall survival (OS), using an α of .20 (wherein P < .20 indicates a positive trial). Secondary end points included progression-free survival (PFS), toxicity, and quality of life (QOL). Herein, we present long-term outcomes from the trial.
RESULTS
Between 2012 and 2016, 99 patients were randomly assigned at 10 centers internationally. The most common primary tumor types were breast (n = 18), lung (n = 18), colorectal (n = 18), and prostate (n = 16). Median follow-up was 51 months. The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank P = .006). The 5-year PFS rate was not reached in arm 1 (3.2%; 95% CI, 0% to 14% at 4 years with last patient censored) and 17.3% in arm 2 (95% CI, 8% to 30%; P = .001). There were no new grade 2-5 adverse events and no differences in QOL between arms.
CONCLUSION
With extended follow-up, the impact of SABR on OS was larger in magnitude than in the initial analysis and durable over time. There were no new safety signals, and SABR had no detrimental impact on QOL.",2020,"The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank P = .006).","['99 patients were randomly assigned at 10 centers internationally', 'patients with a limited number of metastases', 'Oligometastatic Cancers', 'Between 2012 and 2016', 'enrolled patients with a controlled primary malignancy and 1-5 metastatic lesions, with all metastases amenable to']","['stereotactic ablative radiotherapy (SABR', 'Stereotactic Ablative Radiotherapy', 'palliative standard-of-care (SOC) treatments (arm 1) and SOC plus SABR', 'SABR']","['5-year PFS rate', 'QOL', '5-year OS rate', 'overall survival (OS', 'progression-free survival (PFS), toxicity, and quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0449798', 'cui_str': 'Number of metastases'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",99.0,0.206806,"The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank P = .006).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Olson', 'Affiliation': 'BC Cancer, Centre for the North, Prince George, British Columbia, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrow', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Gaede', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Louie', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Haasbeek', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Mulroy', 'Affiliation': 'Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Yaremko', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Schellenberg', 'Affiliation': 'BC Cancer, Surrey Centre, Surrey, British Columbia, Canada.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Ahmad', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Sashendra', 'Initials': 'S', 'LastName': 'Senthi', 'Affiliation': 'Alfred Health Radiation Oncology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaminath', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kopek', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'BC Cancer, Vancouver Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Currie', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Schlijper', 'Affiliation': 'BC Cancer, Centre for the North, Prince George, British Columbia, Canada.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Bauman', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Laba', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'X Melody', 'Initials': 'XM', 'LastName': 'Qu', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00818']
3568,31502349,"Long-term oncological outcomes of minimally invasive radical hysterectomy for early-stage cervical cancer: A retrospective, single-institutional study in the wake of the LACC trial.","AIM
The objective of this study was to investigate the long-term oncological outcomes of minimally invasive radical hysterectomy (MIRH) for the treatment of early-stage cervical cancer retrospectively in the wake of the laparoscopic approach to cervical cancer (LACC) trial.
METHODS
A total of 109 patients with stage IA1 with lymphovascular space involvement, IA2, and IB1 cervical cancers were included in this study. The surgical and oncological outcomes were retrospectively evaluated. All patients underwent type C MIRH with a no-touch isolation technique for cervical tumor.
RESULTS
The median number of resected pelvic lymph nodes was 36 (range, 14-94), and 10 patients (9.2%) had positive nodes. One patient (0.9%) had positive surgical margins. Forty-six patients (42%) underwent adjuvant therapy. The median follow-up time was 73 months (range, 30-146 months). Five patients (4.6%) developed recurrent disease, and 3 patients (2.8%) died of cervical cancer. The 5-year disease-free survival and overall survival rates were 96.3% and 97.2%, respectively. A comparison between patients with tumor diameter ≤ 2 cm (n = 59) and those with tumor diameter > 2 cm (n = 50) did not identify any significant differences, with 5-year disease-free survival 96.6% versus 94.0% and 5-year overall survival 98.3% versus 96.0%, respectively.
CONCLUSION
In this retrospective study, MIRH with a no-touch isolation technique for stage IA to IB1 cervical cancer was a safe approach in terms of oncological outcomes. However, every surgeon who treats early-stage cervical cancer should inform each patient of the results of the LACC trial because it has an exceedingly high impact.",2019,"The 5-year disease-free survival and overall survival rates were 96.3% and 97.2%, respectively.","['early-stage cervical cancer retrospectively in the wake of the laparoscopic approach to cervical cancer (LACC) trial', '109 patients with stage IA1 with lymphovascular space involvement, IA2, and IB1 cervical cancers', 'early-stage cervical cancer']","['type C MIRH with a no-touch isolation technique', 'minimally invasive radical hysterectomy (MIRH', 'adjuvant therapy', 'minimally invasive radical hysterectomy']","['recurrent disease', 'died of cervical cancer', '5-year disease-free survival and overall survival rates', 'median number of resected pelvic lymph nodes', 'positive surgical margins', '5-year overall survival', '5-year disease-free survival']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0204727', 'cui_str': 'Isolation technique'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node group'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",109.0,0.197398,"The 5-year disease-free survival and overall survival rates were 96.3% and 97.2%, respectively.","[{'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Kanno', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Andou', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Shiori', 'Initials': 'S', 'LastName': 'Yanai', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Toeda', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nimura', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Fuyuki', 'Initials': 'F', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Teishikata', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Terumi', 'Initials': 'T', 'LastName': 'Shirane', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Sakate', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Kihira', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Hamasaki', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Sawada', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shirane', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Ota', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurashiki Medical Center, Okayama, Japan.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14116']
3569,31806872,Randomized post-induction and delayed intensification therapy in high-risk pediatric acute lymphoblastic leukemia: long-term results of the international AIEOP-BFM ALL 2000 trial.,,2020,,['high-risk pediatric acute lymphoblastic leukemia'],['Randomized post-induction and delayed intensification therapy'],[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0023452', 'cui_str': 'Lymphoblastic Leukemia, Acute, Childhood'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0277782,,"[{'ForeName': 'Andishe', 'Initials': 'A', 'LastName': 'Attarbaschi', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria. andishe.attarbaschi@stanna.at.""}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Mann', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zimmermann', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Medical School Hannover, Hannover, Germany.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': ""Department of Children and Adolescent Medicine, Children's Hospital, Goethe University, Frankfurt, Germany.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barisone', 'Affiliation': ""Pediatric Onco-Hematology, Regina Margherita Children's Hospital, AOU Città della Salute e della Scienza, Turin, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Basso', 'Affiliation': 'Italian Institute for Genomic Medicine, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Cario', 'Affiliation': 'Department of Pediatrics, Christian-Albrechts-University Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Cazzaniga', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Colombini', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Flotho', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Albert Ludwigs University, Freiburg, Germany.""}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kuhlen', 'Affiliation': ""University Children's Hospital Augsburg, Swabian Children's Cancer Center, Augsburg, Germany.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Eberhard Karls University, Tübingen, Germany.""}, {'ForeName': 'Melchior', 'Initials': 'M', 'LastName': 'Lauten', 'Affiliation': ""Department of Pediatric and Adolescent Medicine, Children's Hospital, University of Lübeck, Lübeck, Germany.""}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Linderkamp', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Medical School Hannover, Hannover, Germany.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Department of Pediatric Hematology-Oncology, IRCCS ""Bambino Gesù"" Children\'s Hospital, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Lo Nigro', 'Affiliation': 'Center of Pediatric Hematology Oncology, Azienda Policlinico-OVE, Catania, Italy.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Möricke', 'Affiliation': 'Department of Pediatrics, Christian-Albrechts-University Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Niggli', 'Affiliation': ""Department of Pediatric Oncology, University Children's Hospital, Zürich, Switzerland.""}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Panzer-Grümayer', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Parasole', 'Affiliation': 'Department of Pediatric Hemato-Oncology, A.O.R.N. Santobono-Pausilipon, Naples, Italy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Caterina Putti', 'Affiliation': 'Department of Woman and Child Health, Clinic of Pediatric Haematology-Oncology, University of Padova, Padova, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Rizzari', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Meinolf', 'Initials': 'M', 'LastName': 'Suttorp', 'Affiliation': 'Department of Pediatrics, Pediatric Hemato-Oncology Unit, Children\'s Hospital, University Hospital ""Carl Gustav Carus"", Dresden, Germany.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Valsecchi', 'Affiliation': 'Center of Biostatistics for Clinical Epidemiology, Department of Health Science, University of Milano-Bicocca, Milano, Italy.'}, {'ForeName': 'Valentino', 'Initials': 'V', 'LastName': 'Conter', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schrappe', 'Affiliation': 'Department of Pediatrics, Christian-Albrechts-University Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-019-0670-y']
3570,31810730,A personalized behavioral intervention implementing mHealth technologies for older adults: A pilot feasibility study.,"Sedentary behavior has been associated with adverse health outcomes such as disturbed sleep in older adults. We conducted a single-group pretest and posttest study to evaluate the feasibility of a personalized behavioral intervention program using mobile health technology in improving physical activity and sleep in older adults. The four-week intervention included: personalized physical activity training, real-time physical activity self-monitoring, interactive prompts and feedback with a smartwatch, phone consultation with an exercise trainer and research team members, and weekly financial incentives for achieving weekly physical activity goals. Eight cognitively intact older adults were recruited and completed the study. Findings suggested that the intervention was feasible in this sample of older adults and provided favorable changes in levels of physical activity during the intervention and at post-intervention. Future studies will include a fully powered trial to evaluate the efficacy of this intervention in sedentary older adults.",2019,Findings suggested that the intervention was feasible in this sample of older adults and provided favorable changes in levels of physical activity during the intervention and at post-intervention.,"['Eight cognitively intact older adults', 'sedentary older adults', 'older adults']","['personalized behavioral intervention implementing mHealth technologies', 'personalized behavioral intervention program using mobile health technology', 'personalized physical activity training, real-time physical activity self-monitoring, interactive prompts and feedback with a smartwatch, phone consultation with an exercise trainer and research team members, and weekly financial incentives for achieving weekly physical activity goals']","['levels of physical activity', 'physical activity and sleep']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0171957,Findings suggested that the intervention was feasible in this sample of older adults and provided favorable changes in levels of physical activity during the intervention and at post-intervention.,"[{'ForeName': 'Junxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Johns Hopkins School of Nursing, 525 North Wolfe Street, Baltimore, MD 21205, United States. Electronic address: jli248@jhu.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hodgson', 'Affiliation': 'University of Pennsylvania School of Nursing, United States.'}, {'ForeName': 'M Melanie', 'Initials': 'MM', 'LastName': 'Lyons', 'Affiliation': 'University of Pennsylvania School of Nursing, United States; The Ohio State University College of Medicine, United States.'}, {'ForeName': 'Ker-Cheng', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'University of Pennsylvania School of Medicine, United States.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'University of Minnesota School of Nursing, United States.'}, {'ForeName': 'Nalaka S', 'Initials': 'NS', 'LastName': 'Gooneratne', 'Affiliation': 'University of Pennsylvania School of Medicine, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.11.011']
3571,32484818,The impact of a high-quality basic life support police-based first responder system on outcome after out-of-hospital cardiac arrest.,"BACKGROUND
Laypersons' efforts to initiate basic life support (BLS) in witnessed Out-of-Hospital Cardiac Arrest (OHCA) remain comparably low within western society. Therefore, in order to shorten no-flow times in cardiac arrest, several police-based first responder systems equipped with automated external defibrillators (Pol-AED) were established in urban areas, which subsequently allow early BLS and AED administration by police officers. However, data on the quality of BLS and AED use in such a system and its impact on patient outcome remain scarce and inconclusive.
METHODS
A total of 85 Pol-AED cases were randomly assigned to a gender, age and first rhythm matched non-Pol-AED control group (n = 170) in a 1:2 ratio. Data on quality of BLS were extracted via trans-thoracic impedance tracings of used AED devices.
RESULTS
Comparing Pol-AED cases and the control group, we observed a similar compression rate per minute (p = 0.677) and compression ratio (p = 0.651), mirroring an overall high quality of BLS administered by police officers. Time to the first shock was significantly shorter in Pol-AED cases (6 minutes [IQR: 2-10] vs. 12 minutes [IQR: 8-17]; p<0.001). While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj. OR: 1.85 [95%CI: 1.06-3.23; p = 0.030]) and a borderline significance for the association with favorable neurological outcome (adj. OR: 1.58 [95%CI: 0.96-2.89; p = 0.052) were observed.
CONCLUSION
We were able to demonstrate an early start and a high quality of BLS and AED use in Pol-AED assessed OHCA cases. Moreover, the presence of Pol-AED care was associated with better patient survival and borderline significance for favorable neurological outcome.",2020,"While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj.",['A total of 85 Pol-AED cases'],['high-quality basic life support police-based first responder system'],"['compression rate per minute', 'quality of BLS', 'survival until hospital discharge', 'compression ratio', 'sustained return of spontaneous circulation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}]",170.0,0.0618399,"While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Krammel', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lobmeyr', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sulzgruber', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Winnisch', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Weidenauer', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Poppe', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Datler', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zeiner', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Keferboeck', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Eichelter', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hamp', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Uray', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schnaubelt', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nuernberger', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}]",PloS one,['10.1371/journal.pone.0233966']
3572,32484850,Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial.,"BACKGROUND
Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention.
METHODS
We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life.
RESULTS
For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77-1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%).
CONCLUSIONS
In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.",2020,"In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.","['enrolling patients at six European medical centres', '1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n\u2009=\u2009772, mean number of daily medications\u2009=\u20099.34) or', 'hospitalized older patients with multi-morbidity and polypharmacy', 'older people during hospitalization']","['standard care alone (control, n\u2009=\u2009765, mean number of daily medications\u2009=\u20099.23) using block randomization stratified by site and admission type']","['occurrence of probable or certain ADRs', 'cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1948041', 'cui_str': 'Surgical and medical procedures'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",1537.0,0.223776,"In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""O'Mahony"", 'Affiliation': 'University College Cork School of Medicine-Medicine Cork Ireland, Cork University Hospital Group, Cork, Ireland.'}, {'ForeName': 'Adalsteinn', 'Initials': 'A', 'LastName': 'Gudmundsson', 'Affiliation': 'Landspitali University Hospital Reykjavik, Landspitali, Iceland.'}, {'ForeName': 'Roy L', 'Initials': 'RL', 'LastName': 'Soiza', 'Affiliation': 'NHS Grampian, University of Aberdeen Institute of Applied Health Sciences-Ageing Clinical and Experimental Research, Aberdeen, UK.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Petrovic', 'Affiliation': 'University of Ghent-Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Jose Cruz-Jentoft', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cherubini', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fordham', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'School of Pharmacy, University College Cork, Cork, Ireland.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Dahly', 'Affiliation': 'University College Cork, Cork, Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gallagher', 'Affiliation': 'Cork University Hospital-Geriatric Medicine, Cork, Ireland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lavan', 'Affiliation': 'University College Cork, School of Medicine-Geriatrics, Cork, Ireland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Curtin', 'Affiliation': 'University College Cork, School of Medicine-Geriatrics, Cork, Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Dalton', 'Affiliation': 'University College Cork, National University of Ireland, Pharmaceutical Care Research Group, School of Pharmacy, Cork Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Cullinan', 'Affiliation': 'Royal College of Surgeons, School of Pharmacy, Dublin, Ireland.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Flanagan', 'Affiliation': 'University College Cork, Clinical Research Facility, Cork, Ireland.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Shiely', 'Affiliation': 'University College Cork, School of Epidemiology and Public Health, Cork, Ireland.'}, {'ForeName': 'Olafur', 'Initials': 'O', 'LastName': 'Samuelsson', 'Affiliation': 'Landspitali University Hospital, Geriatric Medicine Reykjavik, Iceland.'}, {'ForeName': 'Astros', 'Initials': 'A', 'LastName': 'Sverrisdottir', 'Affiliation': 'Landspitali University Hospital, Geriatric Medicine Reykjavik, Iceland.'}, {'ForeName': 'Selvarani', 'Initials': 'S', 'LastName': 'Subbarayan', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen UK.'}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Vandaele', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Meireson', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Montero-Errasquin', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Rexach-Cano', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Correa Perez', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Lozano-Montoya', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Vélez-Díaz-Pallarés', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Cerenzia', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Corradi', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Soledad Cotorruelo Ferreiro', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Dimitri', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marinelli', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Martelli', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Fong Soe Khioe', 'Affiliation': 'University of East Anglia, Faculty of Medicine and Health Sciences, Norwich, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eustace', 'Affiliation': 'University College Cork, National University of Ireland-Clinical Research Facility, Cork, Ireland.'}]",Age and ageing,['10.1093/ageing/afaa072']
3573,32484877,"Very-Low-Calorie Ketogenic Diets with Whey, Vegetable or Animal Protein in Patients with Obesity: A Randomized Pilot Study.","CONTEXT
We compared the efficacy, safety and effect of 45-day isocaloric very-low-calorie ketogenic diets (VLCKDs) incorporating whey, vegetable or animal protein on the microbiota in patients with obesity and insulin resistance to test the hypothesis that protein source may modulate the response to VLCKD interventions.
SUBJECTS AND METHODS
Forty-eight patients with obesity [19 males and 29 females, HOMA index ≥ 2.5, age 56.2±6.1 years, body mass index (BMI) 35.9±4.1 kg/m2] were randomly assigned to three 45-day isocaloric VLCKD regimens (≤800 kcal/day) containing whey, plant or animal protein. Anthropometric indexes; blood and urine chemistry, including parameters of kidney, liver, glucose and lipid metabolism; body composition; muscle strength; and taxonomic composition of the gut microbiome were assessed. Adverse events were also recorded.
RESULTS
Body weight, BMI, blood pressure, waist circumference, HOMA index, insulin, and total and LDL cholesterol decreased in all patients. Patients who consumed whey protein had a more pronounced improvement in muscle strength. The markers of renal function worsened slightly in the animal protein group. A decrease in the relative abundance of Firmicutes and an increase in Bacteroidetes were observed after the consumption of VLCKDs. This pattern was less pronounced in patients consuming animal protein.
CONCLUSIONS
VLCKDs led to significant weight loss and a striking improvement in metabolic parameters over a 45-day period. VLCKDs based on whey or vegetable protein have a safer profile and result in a healthier microbiota composition than those containing animal proteins. VLCKDs incorporating whey protein are more effective in maintaining muscle performance.",2020,A decrease in the relative abundance of Firmicutes and an increase in Bacteroidetes were observed after the consumption of VLCKDs.,"['Forty-eight patients with obesity [19 males and 29 females, HOMA index ≥ 2.5, age', '56.2±6.1 years, body mass index (BMI) 35.9±4.1 kg/m2', 'patients with obesity and insulin resistance', 'Patients with Obesity']","['VLCKDs based on whey or vegetable protein', 'Whey, Vegetable or Animal Protein', '45-day isocaloric very-low-calorie ketogenic diets (VLCKDs) incorporating whey, vegetable or animal protein', '45-day isocaloric VLCKD regimens (≤800 kcal/day) containing whey, plant or animal protein']","['renal function', 'muscle strength', 'Adverse events', 'Body weight, BMI, blood pressure, waist circumference, HOMA index, insulin, and total and LDL cholesterol', 'weight loss', 'Anthropometric indexes; blood and urine chemistry, including parameters of kidney, liver, glucose and lipid metabolism; body composition; muscle strength; and taxonomic composition of the gut microbiome', 'metabolic parameters', 'relative abundance of Firmicutes and an increase in Bacteroidetes']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0042439', 'cui_str': 'Dietary Plant Proteins'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0440447', 'cui_str': 'Animal protein'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",48.0,0.0192069,A decrease in the relative abundance of Firmicutes and an increase in Bacteroidetes were observed after the consumption of VLCKDs.,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Basciani', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Camajani', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Savina', 'Initials': 'S', 'LastName': 'Contini', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Persichetti', 'Affiliation': 'Service of Pharmacovigilance, IRCCS-Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Risi', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Bertoldi', 'Affiliation': 'BMR Genomics s.r.l., Padova, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Strigari', 'Affiliation': 'Department of Medical Physics, Policlinico S. Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Prossomariti', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Mikiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Mariani', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Lubrano', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Genco', 'Affiliation': 'Department of Surgical Sciences, Surgical Endoscopy Unit, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Spera', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Gnessi', 'Affiliation': 'Department of Experimental Medicine, University of Rome ""La Sapienza"", Rome, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa336']
3574,32484891,Cognitive Training Attenuates Decline in Physical Function across 10 Years.,"OBJECTIVES
Poor physical function is associated with negative health and cognitive outcomes. Although nine studies demonstrate that cognitive training reduces age-related declines in physical function, only one has examined effects beyond immediate posttest changes. The current study assessed the impact of three cognitive training programs on physical function measures across 10 years. A second aim examined whether baseline cognitive self-efficacy or depressive symptoms moderated training effects.
METHODS
Using data from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) randomized controlled trial, older adults in a no-contact control condition (n = 698) were compared to those receiving processing speed (n = 702), memory (n = 703), or reasoning (n = 694) training. Intention-to-treat (ITT) and dosage analyses were conducted for grip strength and Turn 360. Participants were followed up to 10 years posttest.
RESULTS
There were no significant ITT effects of processing speed, memory, or reasoning training assignment to any physical function outcome (p > .05). Dosage models indicated that there were small age-related attenuations effects in Turn 360 decline with more processing speed training (b = -.011, p < .001), memory training (b = -.011, p < .001), and reasoning training (b = -.012, p < .001). There was no significant transfer to grip strength. These training gains were greater for those with more baseline depressive symptoms who received more processing speed training (b = -.001, p < .001).
DISCUSSION
This is the first study to demonstrate effects of cognitive training to complex physical function across 10 years.",2020,"There were no significant ITT effects of processing speed, memory, or reasoning training assignment to any physical function outcome (p > .05).","['Physical Function across 10 Years', 'older adults in a no-contact control condition (n = 698) were compared to those receiving processing speed (n = 702), memory (n = 703), or reasoning (n = 694) training', 'across 10 years', 'Using data from the Advanced Cognitive Training for Independent and Vital Elderly']","['cognitive training', 'Cognitive Training', 'cognitive training programs', 'Intention-to-treat (ITT']","['ITT effects of processing speed, memory, or reasoning training assignment to any physical function outcome', 'grip strength', 'memory training', 'physical function measures', 'reasoning training']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0442732', 'cui_str': 'Vital'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",698.0,0.0214714,"There were no significant ITT effects of processing speed, memory, or reasoning training assignment to any physical function outcome (p > .05).","[{'ForeName': 'Briana N', 'Initials': 'BN', 'LastName': 'Sprague', 'Affiliation': 'Department of Human Development and Family Studies, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Phillips', 'Affiliation': 'Atria Senior Living, Louisville, KY, USA.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Ross', 'Affiliation': 'Department of Human Development and Family Studies, The Pennsylvania State University, University Park, PA, USA.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbaa072']
3575,32485323,Moderators of treatment effects in a child maltreatment prevention programme in South Africa.,"BACKGROUND
Previous research has found mixed results on whether the most disadvantaged families benefit as much as less disadvantaged families from parenting interventions designed to reduce child maltreatment, and little in known in low-income settings.
OBJECTIVE
In this study, we test the effects of child, caregiver, household, and community characteristics as treatment moderators of intervention outcomes - child maltreatment and parenting practices. We test characteristics previously examined elsewhere as well as factors relevant to the South African context.
PARTICIPANTS AND SETTING
This analysis includes adolescents (ages 10-18) and their caregivers (N = 552 pairs) who participated in a randomised trial of a parenting programme in the Eastern Cape Province of South Africa.
METHODS
Data from the caregiver and adolescent standardised questionnaires collected at baseline, post-test (1-month post-intervention), and follow-up (5-9 months) were analysed using longitudinal multilevel analyses. We tested seven hypothesised moderators for each of the primary outcomes through interactions of treatment effect with baseline moderators.
RESULTS
No moderator effects were statistically significant after correcting for multiple comparisons testing. Hence, in line with several recent studies examining moderation effects in parenting programmes, our study suggests that parenting interventions aiming to reduce child maltreatment and promote parenting skills in low- and middle-income countries may be similarly effective for families facing various levels of economic, social, and health risk factors.
CONCLUSIONS
It may be useful to explicitly power trials for testing moderator effects, study different types of moderators and use person-centred analyses to further understand variations in treatment effects.",2020,No moderator effects were statistically significant after correcting for multiple comparisons testing.,"['This analysis includes adolescents (ages 10-18) and their caregivers (N = 552 pairs) who participated in a randomised trial of a parenting programme in the Eastern Cape Province of South Africa', 'Data from the caregiver and adolescent standardised questionnaires collected at baseline, post-test (1-month post-intervention), and follow-up (5-9 months) were analysed using longitudinal multilevel analyses', 'child maltreatment prevention programme in South Africa']",[],[],"[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454728', 'cui_str': 'Cape Province'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0814909', 'cui_str': 'Multilevel Analysis'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],[],552.0,0.117227,No moderator effects were statistically significant after correcting for multiple comparisons testing.,"[{'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Department of Social Policy and Intervention, Centre for Evidence-Based Intervention, University of Oxford, Barnett House, 32 Wellington Square, OX1 2ER, Oxford, United Kingdom; Institute of Criminology, University of Cambridge, Sidgwick Avenue, CB3 9DA, Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Department of Social Policy and Intervention, Centre for Evidence-Based Intervention, University of Oxford, Barnett House, 32 Wellington Square, OX1 2ER, Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, J-Block, Groote Schuur Hospital, Observatory, 7925, Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Eisner', 'Affiliation': 'Institute of Criminology, University of Cambridge, Sidgwick Avenue, CB3 9DA, Cambridge, United Kingdom; Jacobs Center for Productive Youth Development, University of Zurich, Andreasstrasse 15, 8050, Zürich, Switzerland. Electronic address: mpe23@cam.ac.uk.'}, {'ForeName': 'Aja Louise', 'Initials': 'AL', 'LastName': 'Murray', 'Affiliation': 'Institute of Criminology, University of Cambridge, Sidgwick Avenue, CB3 9DA, Cambridge, United Kingdom; Department of Psychology, University of Edinburgh, Room F16, Psychology Building, 7 George Square, Edinburgh, EH8 9JZ, United Kingdom. Electronic address: Aja.Murray@ed.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104519']
3576,32485325,A pharmacy liaison-patient navigation intervention to reduce inpatient and emergency department utilization among primary care patients in a Medicaid accountable care organization: A pragmatic trial protocol.,"OBJECTIVE
To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital.
BACKGROUND
Prior studies have demonstrated only modest effects in reducing utilization among safety-net patient populations. Interventions that address health-related social needs have the potential to reduce utilization in these populations.
DESIGN/METHODS
Assignment to treatment condition is by medical record number (odd vs. even) and is unblinded (NCT03919084). Adults age 18-64 within the 3rd to 10th percentile for health care utilization and cost among Medicaid Accountable Care Organization membership attending a primary care visit in the general internal medicine practice at Boston Medical Center enrolled.
DISCUSSION
Our study will advance the field in two ways: 1) by providing evidence about the effectiveness of pharmacy liaisons who also function as patient navigators; and 2) by de-implementing patient navigators. Patients in the enhanced usual care arm will no longer receive the services of a clinic-based patient navigator. In addition, our study includes a novel collaboration with a community-based organization, and focuses on an intermediate-cost patient population, rather than the most costly patient population.",2020,"OBJECTIVE
To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital.
","['connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital', 'Adults age 18-64 within the 3rd to 10th percentile for health care utilization and cost among Medicaid Accountable Care Organization membership attending a primary care visit in the general internal medicine practice at Boston Medical Center enrolled', 'primary care patients in a Medicaid accountable care organization']",['pharmacy liaison-patient navigation intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3179030', 'cui_str': 'Accountable Care Organization'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0200654,"OBJECTIVE
To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital.
","[{'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, 801 Massachusetts Ave, 6th Floor, Boston, MA 02119, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA; Boston University School of Public Health, 715 Albany St, Boston, MA 02118, USA; Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Karen.Lasser@bmc.org.'}, {'ForeName': 'Pablo Buitron', 'Initials': 'PB', 'LastName': 'de la Vega', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, 801 Massachusetts Ave, 6th Floor, Boston, MA 02119, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA; Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Pablo.BuitrondelaVega@bmc.org.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Ashe', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Erin.Ashe@bmc.org.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University School of Public Health, 715 Albany St, Boston, MA 02118, USA. Electronic address: Ziming.Xuan@bmc.org.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Alva', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Sonia.Alva@bmc.org.'}, {'ForeName': 'Leandra', 'Initials': 'L', 'LastName': 'Battisti', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Leandra.Battisti@bmc.org.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Losi', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Stephanie.Losi@bmc.org.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sieber', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Christina.Sieber@bostonabcd.org.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Richards', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Carla.Richards@bostonabcd.org.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Patricia.Sullivan@bostonabcd.org.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Triscari', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Leah.Triscari@bostonabcd.org.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brody', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Lauren.Brody@bostonabcd.org.'}, {'ForeName': 'Mary-Tara', 'Initials': 'MT', 'LastName': 'Roth', 'Affiliation': 'Clinical Research Resources Office, Boston Medical Center, Boston University Medical Campus, 75 E Newton St, Evans Building, 7(th) Floor, Boston, MA 02118, USA. Electronic address: Mary-Tara.Roth@bmc.org.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'LeBlanc', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Alison.LeBlanc@bmc.org.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA; Section of General Academic Pediatrics, Boston Medical Center, 72 East Concord St, Vose Building, 3(rd) Floor, Boston, MA 02118, USA. Electronic address: Michael.Silverstein@bmc.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106046']
3577,32485328,Randomized trial of argatroban plus recombinant tissue-type plasminogen activator for acute ischemic stroke (ARAIS): Rationale and design.,"BACKGROUND
Previous studies have implied the efficacy and safety of argatroban plus recombinant tissue-type plasminogen activator (r-tPA) in patients with acute ischemic stroke. Further trials are needed to establish convincing conclusions in a large sample size.
RESEARCH DESIGN AND METHODS
Argatroban plus r-tPA for Acute Ischemic Stroke (ARAIS) trial is a multicenter, prospective, randomized, open-label, and blind-end point trial. The trial proposes to randomize 808 patients with acute ischemic stroke National Institutes of Health Stroke Scale (NIHSS score≥ 6 at the time of randomization) within 4.5 hours of symptom onset to receive argatroban (100 μg/kg bolus followed by an infusion of 1.0 μg/kg per minute for 48 hours) plus r-tPA or r-tPA alone. The primary end point is the proportion of patients with an excellent outcome of no clinically significant residual stroke deficits (modified Rankin scale 0-1) at 90 days. Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days. Safety end points include symptomatic intracerebral hemorrhage, parenchymal hematoma type 2, and major systemic bleeding.
CONCLUSION
ARAIS trial will evaluate whether argatroban plus r-tPA is superior to r-tPA alone in improving functional outcomes in acute ischemic stroke patients in a large sample population.",2020,"Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days.","['acute ischemic stroke (ARAIS', 'acute ischemic stroke patients in a large sample population', '808 patients with acute ischemic stroke National Institutes of Health Stroke Scale (NIHSS score≥ 6 at the time of randomization) within 4.5\u202fhours of symptom onset to receive', 'patients with acute ischemic stroke']","['argatroban plus recombinant tissue-type plasminogen activator (r-tPA', 'argatroban plus r-tPA', 'argatroban plus recombinant tissue-type plasminogen activator', 'Argatroban plus r-tPA', 'argatroban (100\u202fμg/kg bolus followed by an infusion of 1.0\u202fμg/kg per minute for 48\u202fhours) plus r-tPA or r-tPA alone']","['stroke recurrence or other vascular events', 'symptomatic intracerebral hemorrhage, parenchymal hematoma type 2, and major systemic bleeding', 'NIHSS score', 'proportion of patients with a good outcome (modified Rankin scale 0-2) at 90\u202fdays, early neurological improvement (NIHSS score\u202f≥2-point decrease) at 48\u202fhours, early neurological deterioration (NIHSS score\u202f≥4-point increase', 'functional outcomes', 'proportion of patients with an excellent outcome of no clinically significant residual stroke deficits']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}]",808.0,0.128243,"Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhonghe', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China. Electronic address: chszh@aliyun.com.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China. Electronic address: yilong528@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.003']
3578,32485422,Utilizing the somatosensory system via vibratory stimulation to mitigate knee pain during walking: Randomized clinical trial.,"BACKGROUND
Pain and proprioception deficits are often associated with knee pathologies and resultant quadriceps muscle inhibition. There is a need for new approaches to mitigate active knee pain and restore muscle function during walking. Activating properties of the somatosensory system with common pain and sensory pathways offers a novel opportunity to enhance quadriceps function during walking.
RESEARCH QUESTION
Conduct a controlled clinical trial that investigates the effects of applying intermittent vibrational cutaneous stimulation during walking on knee pain and symptoms and their correlations to gait parameters.
METHODS
This longitudinal controlled cross-over clinical study included thirty-two patients randomly and blindly assigned to active Treatment A and passive Treatment B for 4 weeks with a 2-week washout period between treatments.
RESULTS
Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition. For Treatment A, subjects with low knee flexion moment and knee flexion angle in no-treatment condition exhibited the greatest increase in knee flexion moment/angle in the active treatment condition (R > 0.57, p < 0.001). These changes in gait measures were correlated significantly to changes in pain.
SIGNIFICANCE
This clinical trial indicates that knee pain can be reduced, and gait improved in a manner that enhances quadriceps function by applying intermittent cutaneous stimulation during gait in patients following knee injury or disease. The correlation between decreased pain and improved gait suggests that rehabilitation and exercise therapy may benefit from this treatment.",2020,"RESULTS
Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.",['knee pain during walking'],"['somatosensory system via vibratory stimulation', 'intermittent vibrational cutaneous stimulation']","['knee flexion moment/angle', 'gait measures', 'pain']","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0150184', 'cui_str': 'Cutaneous stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",32.0,0.0771875,"RESULTS
Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA. Electronic address: ariellef@stanford.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.030']
3579,32485743,Letter to the Editor from Melanson et al (second letter): Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals.,,2020,,[],['High Diet-Induced Thermogenesis'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]",[],,0.01543,,"[{'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda MD USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa350']
3580,32485753,Confirmation Bias Affects Estimation of Blood Loss and Amniotic Fluid Volume: A Randomized Simulation-Based Trial.,"OBJECTIVE
This study was aimed to determine if confirmation bias affects diagnoses in obstetrics, specifically estimation of blood loss and amniotic fluid volume.
STUDY DESIGN
We performed a randomized simulation-based trial. Participants went through the following three consecutive scenarios: (1) the first involved estimating the volume of blood (actually a blood-like substance) in a container at the simulation model's perineum. The actual volume was either 500 or 1,500 mL. Participants were told it was blood seen after a vaginal delivery. One group was told that the ""patient"" was normotensive, the other was told that the ""patient"" was hypotensive. (2) The second scenario involved estimation of amniotic fluid from an ultrasound picture of four quadrants, with one group told that the patient was normotensive and the other group told that the patient had chronic hypertension. (3) The third scenario was a ""negative image"" of the first (i.e., if they had been randomized to the 500 mL/normotensive in scenario one, then they would be presented with the 1,500 mL/hypotensive). They also filled a survey including demographics and tolerance of ambiguity and confirmation bias scales.
RESULTS
From April 2018 through May 2018, a convenience sample of 85 providers was recruited. Participants were more likely to overestimate blood loss when they were told that the patient was hypotensive ( p = 0.024), in comparison to when they were told the patient had normal blood pressure. They were also less likely to estimate the amniotic fluid as normal when they were told that the patient was hypertensive ( p = 0.032).
CONCLUSION
Confirmation bias affects estimates of blood loss and amniotic fluid.",2020,"Participants were more likely to overestimate blood loss when they were told that the patient was hypotensive ( p = 0.024), in comparison to when they were told the patient had normal blood pressure.","['From April 2018 through May 2018, a convenience sample of 85 providers was recruited']",[],"['chronic hypertension', 'Blood Loss and Amniotic Fluid Volume', 'overestimate blood loss', 'blood loss and amniotic fluid', 'amniotic fluid', 'normal blood pressure']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0553034', 'cui_str': 'Amniotic fluid volume'}, {'cui': 'C0002638', 'cui_str': 'Amniotic fluid'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}]",,0.168187,"Participants were more likely to overestimate blood loss when they were told that the patient was hypotensive ( p = 0.024), in comparison to when they were told the patient had normal blood pressure.","[{'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Atallah', 'Affiliation': 'Department of Obstetrics and Gynecology, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Rafine', 'Initials': 'R', 'LastName': 'Moreno-Jackson', 'Affiliation': 'Department of Obstetrics and Gynecology, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'Department of Obstetrics and Gynecology, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Fisher', 'Affiliation': 'Department of Obstetrics and Gynecology, Maimonides Medical Center, Brooklyn, New York.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Weedon', 'Affiliation': 'Department of Epidemiology & Biostatistics, State University of New York (SUNY) Downstate, School of Public Health, Brooklyn, New York.'}, {'ForeName': 'Sharifa', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Department of Psychology, Hunter College, City University of New York, Brooklyn, New York.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Minkoff', 'Affiliation': 'Department of Obstetrics and Gynecology, Maimonides Medical Center, Brooklyn, New York.'}]",American journal of perinatology,['10.1055/s-0040-1712167']
3581,32485759,Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial.,"OBJECTIVE
Virtual reality (VR) represents a potential method for easing labor pain and in nonpregnant patients has been shown to achieve similar or greater analgesia than hydromorphone. Few studies of VR have been performed in pregnant women. The aim of this randomized controlled trial (RCT) is to evaluate whether VR is effective in reducing pain in laboring women.
STUDY DESIGN
An open-label, RCT of nulliparous, term women in labor in a tertiary care hospital. We included women with a pain score level of 4 to 7 having regular contractions at least every 5 minutes. We excluded women who had received any pharmacologic pain relief including neuraxial analgesia and those with contraindications to VR. Participants were randomized to up to 30 minutes of either VR or the control arm (no additional intervention). Our primary outcome was the difference in differences from pre- to postintervention pain score. Prespecified secondary outcomes included postintervention pain scores, duration of intervention use, pharmacologic analgesia use, maternal vitals, and obstetric outcomes.
RESULTS
From March 2018 to February 2019, 40 subjects were enrolled, randomized, and completed the study; 19 were randomized to control and 21 to the VR arm. Most baseline characteristics were similar between groups. For the primary outcome, those assigned to the control arm had a statistically significant increase in pain of +0.58, while the VR arm had a significant reduction in pain of -0.52 ( p = 0.03). There was also a difference in the proportion who had a minimum clinically important difference in pain (0% control and 23.8% VR; p = 0.049). Postintervention maternal heart rate was higher in the control arm (86.8 vs. 76.3, p = 0.01). Most other secondary outcomes did not differ.
CONCLUSION
In our study, we found that VR was effective for reducing pain in women in labor as compared with those receiving no intervention.
KEY POINTS
· Virtual reality (VR) represents a nonpharmacologic option for pain relief.. · VR has been little studied in pregnant or laboring women.. · VR was associated with a reduction in pain in nulliparous women in labor..",2020,"For the primary outcome, those assigned to the control arm had a statistically significant increase in pain of +0.58, while the VR arm had a significant reduction in pain of -0.52 ( p = 0.03).","['nulliparous women in labor', 'nulliparous, term women in labor in a tertiary care hospital', 'laboring women', 'women who had received any pharmacologic pain relief including neuraxial analgesia and those with contraindications to VR', 'women with a pain score level of 4 to 7 having regular contractions at least every 5\u2009minutes', 'From March 2018 to February 2019, 40 subjects were enrolled, randomized, and completed the study; 19 were randomized to control and 21 to the VR arm', 'Laboring Women', 'nonpregnant patients', 'pregnant women']","['Virtual Reality', 'VR', 'VR or the control arm (no additional intervention', 'Virtual reality (VR', 'hydromorphone']","['Postintervention maternal heart rate', 'postintervention pain score', 'postintervention pain scores, duration of intervention use, pharmacologic analgesia use, maternal vitals, and obstetric outcomes', 'pain']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0567125', 'cui_str': 'Regular uterine contractions'}, {'cui': 'C0585314', 'cui_str': 'Every five minutes'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.21167,"For the primary outcome, those assigned to the control arm had a statistically significant increase in pain of +0.58, while the VR arm had a significant reduction in pain of -0.52 ( p = 0.03).","[{'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Brennan M R', 'Initials': 'BMR', 'LastName': 'Spiegel', 'Affiliation': 'Division of Informatics, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Gregory', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California.'}]",American journal of perinatology,['10.1055/s-0040-1708851']
3582,32485769,"[A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma - SUNNIFORECAST AN 41/16 der AUO].",,2020,,['Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma - SUNNIFORECAST AN 41/16 der AUO'],['Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy'],[],"[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]",[],,0.0160919,,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rexer', 'Affiliation': 'AUO Geschäftsstelle, Seestr. 11, 17252 Schwarz, AUO@MeckEvidence.de.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bergmann', 'Affiliation': 'Leiter der klinischen Prüfung (LKP), Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590 Frankfurt.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Steiner', 'Affiliation': 'Organgruppensprecher der Arbeitsgemeinschaft Urologische Onkologie in der Deutschen Krebsgesellschaft e. V., Kuno-Fischer-Str. 8, 14057 Berlin.'}]",Aktuelle Urologie,['10.1055/a-1079-7621']
3583,32485778,Whole-body Electromyostimulation plus Caloric Restriction in Metabolic Syndrome.,"We investigated early effects of Whole-Body Electromyostimulation added to hypocaloric diet on metabolic syndrome features in sedentary middle-aged individuals. We randomly assigned 25 patients to Whole-Body Electromyostimulation plus caloric restriction or caloric restriction alone for 26 weeks. Anthropometrics, blood pressure, fasting glucose and insulin, HOMA-IR, glycated hemoglobin, lipids, uric acid, creatinphosphokynase, C-reactive protein were assessed. Body composition was evaluated with direct-segmental, multi-frequency Bioelectrical Impedance Analysis. Both groups lost approximately 10% of weight, with similar effects on waist circumference and fat mass. Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03). Whole-Body Electromyostimulation plus caloric restriction group experienced greater percent reductions in insulin (-45.5±4.4 vs. -28.2±3.6%, p=0.002), HOMA-IR (-51.3±3.2 vs. -25.1±1.8%, p=0.001), triglycerides (-22.5±2.9 vs. -4.1±1.6%, p=0.004) and triglycerides/HDL (p=0.028). Subjects trained with Whole-Body Electromyostimulation had also significant improvement in systolic pressure (138±4 vs. 126±7 mmHg, p=0.038). No discontinuations for adverse events occurred. In middle-aged sedentary subjects with the metabolic syndrome, Whole-Body Electromyostimulation with caloric restriction for 26 weeks can improve insulin-resistance and lipid profile compared to diet alone. Further studies are needed to ascertain long-term efficacy and feasibility of this approach in individuals with the metabolic syndrome.",2020,"Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03).","['middle-aged sedentary subjects with the metabolic syndrome', 'Metabolic Syndrome', 'individuals with the metabolic syndrome', 'sedentary middle-aged individuals']","['Whole-Body Electromyostimulation plus caloric restriction or caloric restriction alone', 'Whole-Body Electromyostimulation added to hypocaloric diet']","['triglycerides', 'insulin-resistance and lipid profile', 'systolic pressure', 'metabolic syndrome features', 'waist circumference and fat mass', 'Body composition', 'HOMA-IR', 'free-fat mass', 'triglycerides/HDL', 'adverse events', 'Anthropometrics, blood pressure, fasting glucose and insulin, HOMA-IR, glycated hemoglobin, lipids, uric acid, creatinphosphokynase, C-reactive protein']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",25.0,0.0367421,"Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03).","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Bellia', 'Affiliation': 'Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ruscello', 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Bolognino', 'Affiliation': 'Sapienza University of Rome, Unitelma Sapienza, Roma, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Briotti', 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Paolo Roberto', 'Initials': 'PR', 'LastName': 'Gabrielli', 'Affiliation': 'School of Sports and Exercise Sciences , University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Silvestri', 'Affiliation': 'Urban Fitness EMS Institute, Urban Fitness, Milano, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rosazza', 'Affiliation': 'Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Neuroradiology Dept., Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ambruoso', 'Affiliation': 'Faculty of Medicine and Surgery, School of Sports and Exercise Sciences, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Lombardo', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernardini', 'Affiliation': 'Faculty of Medicine and Surgery, School of Sports and Exercise Sciences, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Calabrese', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lauro', 'Affiliation': 'Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': ""D'Ottavio"", 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}]",International journal of sports medicine,['10.1055/a-1171-2003']
3584,32485781,The Pharmacokinetics of Fluticasone Furoate Given Intranasally in Healthy Subjects Using an Ultra-Sensitive Analytical Assay.,"PURPOSE
It has been previously shown that the complete pharmacokinetic profile, in particular the elimination phase, of intranasal fluticasone furoate has not been fully characterized due to the inability to quantify concentrations at low enough levels. This study was designed to evaluate the pharmacokinetic profile of intranasal FF using a validated, ultra-sensitive analytical method in healthy subjects.
METHODS
This was an open-label, single-dose, two-period, one-treatment, crossover study. A dose of 880 µg fluticasone furoate was administered intra nasally. Blood samples for pharmacokinetic analysis were collected at 23 time points up to 36 h and analyzed for FF plasma levels using a lower limit of quantitation (LLOQ) of 0.1 pg/mL. Medical and adverse events (AE) were monitored throughout the study.
RESULTS
Eighteen subjects were enrolled in and 17 completed the study. The results showed that all 17 subjects had measurable fluticasone furoate plasma concentrations at all time points with a clearly defined elimination phase, thus allowing estimation of AUC inf and t 1/2 . Median T max was 1.33 h (range=0.75-6.00), mean C max was 13.05±7.59 pg/mL, mean AUC t was 148.48±77.76 pg/mL*h, mean AUC inf was 279.07±187.81 pg/mL*h, and mean t 1/2 was 31.67±29.23 h. In total 4 subjects (22.2%) experienced 4 AEs.
CONCLUSION
Using a lower LLOQ than what has been previously reported, a complete characterization of intranasal fluticasone furoate pharmacokinetics, including a clearly defined terminal elimination phase, was achieved. This method will allow for further investigations into the pharmacokinetics of fluticasone furoate.",2020,"Median T max was 1.33 h (range=0.75-6.00), mean C max was 13.05±7.59 pg/mL, mean","['Eighteen subjects were enrolled in and 17 completed the study', 'healthy subjects', 'Healthy Subjects Using an Ultra-Sensitive Analytical Assay']","['fluticasone furoate', 'Fluticasone Furoate', 'intranasal FF']","['AUC inf', 'measurable fluticasone furoate plasma concentrations', 'Median T max']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",18.0,0.0300749,"Median T max was 1.33 h (range=0.75-6.00), mean C max was 13.05±7.59 pg/mL, mean","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Bouhajib', 'Affiliation': 'Bioanalytical Laboratory, Pharma Medica Research Inc, Mississauga, Canada.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Tayab', 'Affiliation': 'Scientific Affairs, Pharma Medica Research Inc, Mississauga, Canada.'}]",Drug research,['10.1055/a-1170-3083']
3585,32485294,Immunological and behavioral responses to in vivo lipopolysaccharide administration in young and healthy obese and normal-weight humans.,"Obesity is associated with an increase prevalence of neuropsychiatric symptoms and diseases, such as depression. Based on the facts that pro-inflammatory cytokines are able to modulate behavior, and that obesity is characterized by a chronic low-grade inflammatory state, inflammation has been hypothesized to contribute to the neuropsychiatric comorbidity in obese individuals. However, a causal link between inflammation and the development of neuropsychiatric symptoms is hard to establish in humans. Here, we used an inflammatory stimulus, i.e. the intravenous injection of lipopolysaccharide (LPS), in a double-blind placebo-controlled design to determine the vulnerability of obese individuals to inflammation-induced behavioral changes. The hypothesis was that obese individuals would show heightened behavioral response compared to normal-weight subjects for the same inflammatory stimulus, reflecting an increased sensitivity to the behavioral effects of pro-inflammatory cytokines. LPS (dose 0.8 ng/kg body weight, adjusted for blood volume in obese subjects) and placebo (saline) were intravenously injected in 14 obese healthy subjects and 23 normal-weight healthy subjects in a within-subject, randomized, crossover design. LPS administration induced, in both groups, an acute increase in blood concentrations of cytokines (interleukin-6, tumor necrosis factor-α and IL-10), as well as in body temperature, cortisol, norepinephrine, sickness symptoms, fatigue, negative mood and state anxiety. There were little differences in the immune and behavioral responses to LPS between obese and normal-weight subjects, but the cortisol response to LPS was strongly attenuated in obese individuals. Higher percentage of body fat was related to a lower cortisol response to LPS. Taken together, the population of young and healthy obese individuals in this study did not exhibit an increased behavioral sensitivity to cytokines, but an attenuated cortisol response to the immune challenge. Future studies will need to determine whether additional physiological and psychological factors interact with the state of obesity to increase the risk for inflammation-induced neuropsychiatric symptoms.",2020,"LPS administration induced, in both groups, an acute increase in blood concentrations of cytokines (interleukin-6, tumor necrosis factor-α and IL-10), as well as in body temperature, cortisol, norepinephrine, sickness symptoms, fatigue, negative mood and state anxiety.","['obese individuals to inflammation-induced behavioral changes', 'obese individuals', 'young and healthy obese and normal-weight humans', '14 obese healthy subjects and 23 normal-weight healthy subjects']","['placebo (saline', 'lipopolysaccharide administration', 'lipopolysaccharide (LPS', 'LPS']","['Immunological and behavioral responses', 'blood concentrations of cytokines (interleukin-6, tumor necrosis factor-α and IL-10), as well as in body temperature, cortisol, norepinephrine, sickness symptoms, fatigue, negative mood and state anxiety', 'behavioral response', 'cortisol response to LPS']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",14.0,0.0574229,"LPS administration induced, in both groups, an acute increase in blood concentrations of cytokines (interleukin-6, tumor necrosis factor-α and IL-10), as well as in body temperature, cortisol, norepinephrine, sickness symptoms, fatigue, negative mood and state anxiety.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lasselin', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany; Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden. Electronic address: julie.lasselin@su.se.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hebebrand', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Duisburg-Essen.'}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Boy', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Weskamp', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Analena', 'Initials': 'A', 'LastName': 'Handke', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Hasenberg', 'Affiliation': 'Helios Adipositas Zentrum West, Helios St. Elisabeth Klinik Oberhausen, Witten/Herdecke University, Josefstr. 3, 46045 Oberhausen, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Remy', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Duisburg-Essen.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Föcker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Duisburg-Essen.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Unteroberdörster', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany; Department of Neurosurgery, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brinkhoff', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany; Department of Nephrology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.05.071']
3586,32485550,Effects of couple conflict on alcohol craving: Does intimate partner violence play a role?,"OBJECTIVE
Social stress in the form of maladaptive relationship conflict is a common precipitant to alcohol misuse and problems. Research has also established a clear causal association between alcohol misuse and relationship conflict in the form of intimate partner violence (IPV). Despite the robust literature linking relationship conflict and problematic drinking using survey methodology, no laboratory studies have examined the proximal association between relationship conflict and alcohol craving among couples, or the influence of IPV perpetration and victimization on this association.
METHOD
As part of a larger randomized controlled trial, 30 different-sex community couples with substance misuse completed a laboratory conflict resolution task. Participants reported subjective alcohol craving on a Likert-type scale immediately, before, and after the task. Conflict behaviors were coded by trained observers. Analyses were conducted using a multilevel modeling framework to account for the dyadic nature of the data.
RESULTS
Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only. Contrary to our hypotheses, no main or moderating effects of conflict behaviors, IPV perpetration, or IPV victimization were found for women.
CONCLUSIONS
Findings from this exploratory study suggest that in this sample, relationship conflict and IPV in one's current relationship played a more impactful role on acute alcohol craving among men compared to women. Future studies should examine the role of specific conflict behaviors on alcohol craving and relapse risk, and patterns of communication that might increase or reduce risk for exacerbated alcohol craving.",2020,"RESULTS
Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.",['30 different-sex community couples with substance misuse completed a laboratory conflict resolution task'],['couple conflict'],"['subjective alcohol craving', 'negative and positive conflict behaviors and alcohol craving', 'conflict behaviors, IPV perpetration, or IPV victimization', 'acute alcohol craving', 'alcohol craving', 'Conflict behaviors']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0159769,"RESULTS
Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States; Ralph H. Johnson VA Medical Center, United States. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States.'}, {'ForeName': 'Ruschelle M', 'Initials': 'RM', 'LastName': 'Leone', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Oesterle', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106474']
3587,32485622,Effects of cognitive-behavioural therapy for stress management on stress and hair cortisol levels in pregnant women: A randomised controlled trial.,"OBJECTIVE
To demonstrate the effectiveness of a cognitive behavioural therapy for stress management in pregnant women in the reduction of psychological stress and hair cortisol levels.
METHODS
The trial was controlled and randomised, with a total of 78 pregnant women: control group (n-39) and Cognitive Behavioural Therapy group (n-39). To test the therapy's efficacy, an evaluation of the primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience) was conducted before and after the treatment. The therapy was conducted during 8 sessions (one per week) in a group setting. The study was registered as a Randomised Controlled Trial with the code NCT03404141.
RESULTS
The results showed a group time interaction between hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms. These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
CONCLUSIONS
Using a novel way of assessing chronic stress (psychological and objective measures as hair cortisol levels), this is the first study that has shown a decrease in both the levels of cortisol in hair and in psychological stress. This decline could have implications for maternal and fetal health.",2020,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
","['78 pregnant women', 'pregnant women in the reduction of psychological stress and hair cortisol levels', 'pregnant women']","['cognitive behavioural therapy', 'cognitive-behavioural therapy', 'control group (n-39) and Cognitive Behavioural Therapy group (n-39']","['hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms', 'primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience', 'stress and hair cortisol levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",78.0,0.0699261,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Puertas-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Strivens-Vilchez', 'Affiliation': 'Midwifery Department, Gongora Primary Health Center, Granada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gonzalez-Perez', 'Affiliation': 'Department of Pharmacology, CIBERehd, School of Pharmacy, Instituto de Investigación Biosanitariaibs.GRANADA, University of Granada, Granada, Spain. Electronic address: raquel.gonzalez@ciberehd.org.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Peralta-Ramirez', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110162']
3588,32485633,Effect of hippotherapy on walking performance and gait parameters in people with multiple sclerosis.,"BACKGROUND
Walking dysfunction is one of the most common symptoms of multiple sclerosis (MS).
OBJECTIVE
To evaluate the effects of an 8-week hippotherapy intervention on walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS; and to examine whether the effects of hippotherapy on walking performance are mediated by changes in spatiotemporal gait parameters.
METHODS
Participants were assigned into a hippotherapy intervention group (n = 17) or a control group (n = 16). The intervention included 16 sessions of 30-minutes of hippotherapy conducted twice a week. Participants underwent the 25-foot walk test (T25FW) and 6-minute walk test (6MWT), as primary outcomes, and spatiotemporal gait evaluation using GaitRite system, as secondary outcomes, before and after intervention. The data were examined using mixed model ANOVA with Bonferroni post hoc. Mediation analysis was conducted as per Baron and Kenny's criteria.
RESULTS
Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control. Only balance time (p = 0.043), stance time (p = 0.031), and absolute (p = 0.004) and relative (p = 0.017) double support time were identified as significant mediators of the effects of hippotherapy on walking performance evaluated by T25FW. There was no significant mediator for 6MWT (all p>0.05).
CONCLUSION
Hippotherapy improved walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS, and changes in walking performance, evaluated by T25FW, were partially driven by reduction in stance time and double support time and increase in balance time. Hippotherapy may be a useful complimentary treatment approach for improving walking in people with MS.",2020,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","['people with relapsing-remitting MS', 'people with multiple sclerosis', 'Participants', 'people with MS']","['hippotherapy intervention', 'Hippotherapy', 'hippotherapy', '25-foot walk test (T25FW) and 6-minute walk test (6MWT']","['T25FW time', 'walking performance and spatiotemporal gait parameters', '6MWT distance', 'walking performance and gait parameters', 'stance time', 'balance time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0352318,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","[{'ForeName': 'Andréa Gomes', 'Initials': 'AG', 'LastName': 'Moraes', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil. Electronic address: deyafisio9@hotmail.com.'}, {'ForeName': 'Silvia Gonçalves Ricci', 'Initials': 'SGR', 'LastName': 'Neri', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham,Birmingham, AL, United States.'}, {'ForeName': 'Carlos Bernardo', 'Initials': 'CB', 'LastName': 'Tauil', 'Affiliation': 'Faculty of Medicine, University of Brasília, DF, Brazil.'}, {'ForeName': 'Felipe von', 'Initials': 'FV', 'LastName': 'Glehn', 'Affiliation': 'Department of Medical Clinic, Faculty of Medicine, University of Brasilia, Brasilia, DF and Department of Immunology, University of Unicamp, SP, Brazil.'}, {'ForeName': 'Éber Castro', 'Initials': 'ÉC', 'LastName': 'Corrêa', 'Affiliation': 'Clinen, Neurology and Endocrinology Clinic, Brasília, DF, Bazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'de David', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102203']
3589,32485640,Improving B-mode ultrasound diagnostic performance for focal liver lesions using deep learning: A multicentre study.,"BACKGROUND
The diagnosis performance of B-mode ultrasound (US) for focal liver lesions (FLLs) is relatively limited. We aimed to develop a deep convolutional neural network of US (DCNN-US) for aiding radiologists in classification of malignant from benign FLLs.
MATERIALS AND METHODS
This study was conducted in 13 hospitals and finally 2143 patients with 24,343 US images were enrolled. Patients who had non-cystic FLLs with pathological results were enrolled. The FLLs from 11 hospitals were randomly divided into training and internal validations (IV) cohorts with a 4:1 ratio for developing and evaluating DCNN-US. Diagnostic performance of the model was verified using external validation (EV) cohort from another two hospitals. The diagnosis value of DCNN-US was compared with that of contrast enhanced computed tomography (CT)/magnetic resonance image (MRI) and 236 radiologists, respectively.
FINDINGS
The AUC of Model LBC for FLLs was 0.924 (95% CI: 0.889-0.959) in the EV cohort. The diagnostic sensitivity and specificity of Model LBC were superior to 15-year skilled radiologists (86.5% vs 76.1%, p = 0.0084 and 85.5% vs 76.9%, p = 0.0051, respectively). Accuracy of Model LBC was comparable to that of contrast enhanced CT (both 84.7%) but inferior to contrast enhanced MRI (87.9%) for lesions detected by US.
INTERPRETATION
DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.",2020,"INTERPRETATION
DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","['focal liver lesions using deep learning', '11 hospitals', '13 hospitals and finally 2143 patients with 24,343 US images were enrolled', 'Patients who had non-cystic FLLs with pathological results were enrolled']",['deep convolutional neural network of US (DCNN-US'],"['AUC of Model LBC for FLLs', 'Diagnostic performance', 'diagnostic sensitivity and specificity of Model LBC were superior to 15-year skilled radiologists']","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1318045', 'cui_str': 'AKAP13 protein, human'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}]",2143.0,0.0256485,"INTERPRETATION
DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Centers for Biomedical Engineering, University of Science and Technology of China, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'School of Mathematical Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Tianan', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound, the First Affiliated hospital, College of Medicine, Zhejiang University, Hangzhou, Jiangsu, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': 'Department of Ultrasound, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasound Diagnosis, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Harbin The First Hospital, Harbin, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Ultrasound, Ma'anshan People's Hospital, Ma'anshan, China.""}, {'ForeName': 'Jintang', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Diagnostic Ultrasound, Xiangya Hospital, Changsha, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Department of Ultrasound, Central Theater Command General Hospital, Chinese People's Liberation Army, Wuhan, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Diagnostic Ultrasound, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Ultrasound, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Ultrasound, Fujian Cancer Hospital&Fujian Medical University Cancer Hospita, Fuzhou, China.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Rongqin', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: zhengrq@mail.sysu.edu.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: jiemi301@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine, Beihang University, Beijing, China. Electronic address: jie.tian@ia.ac.cn.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: liangping301@hotmail.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102777']
3590,30040242,Oral Bioavailability and Pharmacokinetics of Nonanimal Chondroitin Sulfate and Its Constituents in Healthy Male Volunteers.,"The pharmacokinetic profile of a new 800-mg tablet of nonanimal chondroitin sulfate (CS) (Mythocondro®, 800-mg tablets, Gnosis S.p.A., Italy) was investigated vs an animal CS in healthy volunteers for a total period of 48 hours. After a single 2400-mg dose of the test and the reference formulation, total CS, the compositional disaccharides (ΔDi6S, ΔDi4S and ΔDi0S), and the overall charge density were quantified in plasma. The safety and tolerability profile after a single dose of this new nonanimal CS tablets was excellent. After baseline-corrected concentrations, an overall greater plasma concentration was observed after 24 hours of ∼44% and after 48 hours of ∼45% from administration of nonanimal when compared to animal-derived CS. Moreover, nonanimal CS increases the specific sulfation in the 6-position of N-acetyl-galactosamine in human plasma CS and, as a consequence, the overall charge density, reaching double values (0.91), after 48 hours compared to bovine CS and to endogenous CS. In conclusion, nonanimal CS, possessing a lower molecular weight than an animal-derived sample, produces a greater CS concentration for a more prolonged period of time in plasma and an increase in charge density and specific 6-sulfation of endogenous plasma CS.",2019,"Moreover, nonanimal CS increases the specific sulfation in the 6-position of N-acetyl-galactosamine in human plasma CS and, as a consequence, the overall charge density, reaching double values (0.91), after 48 hours compared to bovine CS and to endogenous CS.","['Healthy Male Volunteers', 'healthy volunteers for a total period of 48\xa0hours']","['nonanimal chondroitin sulfate (CS) (Mythocondro®', 'Nonanimal Chondroitin Sulfate']","['specific sulfation', 'plasma concentration', 'charge density and specific 6-sulfation of endogenous plasma CS', 'safety and tolerability profile']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]","[{'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0977188,"Moreover, nonanimal CS increases the specific sulfation in the 6-position of N-acetyl-galactosamine in human plasma CS and, as a consequence, the overall charge density, reaching double values (0.91), after 48 hours compared to bovine CS and to endogenous CS.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Volpi', 'Affiliation': 'Department of Life Sciences, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mantovani', 'Affiliation': 'Department of Life Sciences, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galeotti', 'Affiliation': 'Department of Life Sciences, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Bianchi', 'Affiliation': 'Gnosis S.p.A, Desio, MB, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Straniero', 'Affiliation': 'Department di Pharmaceutical Sciences, University of Milano, Milano, Italy.'}, {'ForeName': 'Ermanno', 'Initials': 'E', 'LastName': 'Valoti', 'Affiliation': 'Department di Pharmaceutical Sciences, University of Milano, Milano, Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Miraglia', 'Affiliation': 'Gnosis S.p.A, Desio, MB, Italy.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.587']
3591,30905065,On-treatment changes of serum Wisteria floribunda agglutinin-positive Mac-2 binding protein are associated with the regression of liver fibrosis in chronic hepatitis B patients on interferon α add-on therapy.,"Wisteria floribunda agglutinin-positive Mac-2-binding protein (M2BP) has been identified as a predictor for the response of interferon α (IFN-α) in patients with viral hepatitis. However, whether serum glycosylation isomer of M2BP (M2BPGi) was associated with the regression of liver fibrosis in patients with chronic hepatitis B (CHB) during IFN-α add-on therapy is still unknown. CHB patients were treated with entecavir for 26 weeks followed by entecavir plus pegylated IFN-α for 52 weeks. Liver biopsies were taken at baseline and treatment week 78. The regression of fibrosis was identified according to Ishak standard or Ishak plus Progressive-Indeterminate-Regressive (P-I-R) standard. Serum M2BPGi and liver function tests were measured at baseline and every 26 weeks of treatment. A total of 72 CHB patients were included in the present study. Serum M2BPGi was correlated with fibrosis and necroinflammation both at baseline and week 78. If Ishak standard was used as the reference, only the percent change of M2BPGi at week 52 from week 26 (Δ%M2BPGi 26w-52W ) was independently associated with fibrosis regression at treatment week 78, the area under the ROC curve (AUROC) of Δ%M2BPGi 26w-52W for predicting fibrosis regression was 0.705. As for Ishak plus P-I-R standard, the AUROC of the predictive model for fibrosis regression (0.896*M2BPGi 52W + 0.363*necroinflammation score 0w + 2.051*Ishak score 0w - 4.489) was 0.888. These data indicated that dynamic changes of serum M2BPGi were associated with fibrosis regression in CHB patients on IFN-α add-on therapy.",2019,Serum M2BPGi was correlated with fibrosis and necroinflammation both at baseline and week 78.,"['CHB patients', 'chronic hepatitis B patients', 'patients with chronic hepatitis B (CHB', 'patients with viral hepatitis', '72 CHB patients']","['Wisteria floribunda agglutinin-positive Mac-2-binding protein (M2BP', 'entecavir plus pegylated IFN-α', 'interferon α (IFN-α', 'entecavir']","['Serum M2BPGi', 'Serum M2BPGi and liver function tests']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis'}]","[{'cui': 'C0078501', 'cui_str': 'Wisteria floribunda lectin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0217525', 'cui_str': 'LGALS3BP protein, human'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}]",72.0,0.0166557,Serum M2BPGi was correlated with fibrosis and necroinflammation both at baseline and week 78.,"[{'ForeName': 'Tianhui', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Yameng', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Jialing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Systems Biomedicine Ministry of Education, Shanghai Center for Systems Biomedicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Key Laboratory of Systems Biomedicine Ministry of Education, Shanghai Center for Systems Biomedicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Yongpeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hongxin', 'Initials': 'H', 'LastName': 'Piao', 'Affiliation': 'Department of\xa0Infectious\xa0Diseases, Affiliated Hospital of Yanbian University, Yanji, China.'}, {'ForeName': 'Lungen', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Youqing', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Digestive System, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': ""Hepatology Institute, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yuemin', 'Initials': 'Y', 'LastName': 'Nan', 'Affiliation': 'Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Guofeng', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Second Liver Cirrhosis Diagnosis and Treatment Center, Military Hospital of China, Beijing, China.'}, {'ForeName': 'Huanwei', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Disease, The Fifth Hospital of Shijiazhuang City, Shijiazhuang, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Hepatopancreatobiliary and Splenic Medicine, Affiliated Hospital, Logistics University of People's Armed Police Force, Tianjin, China.""}, {'ForeName': 'Huiguo', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Department of Gastroenterology and Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Pathology, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tailing', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Ou', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Clinical Epidemiology and Evidence-Based Medicine Unit, National Clinical Research Center for Digestive Diseases, Beijing, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Clinical Epidemiology and Evidence-Based Medicine Unit, National Clinical Research Center for Digestive Diseases, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cong', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Systems Biomedicine Ministry of Education, Shanghai Center for Systems Biomedicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis & National Clinical Research Center of Digestive Diseases, Beijing, China.'}]",Journal of medical virology,['10.1002/jmv.25465']
3592,32494177,"Erratum: Daily Intake of Kaempferia parviflora Extract Decreases Abdominal Fat in Overweight and Preobese Subjects: A Randomized, Double-Blind, Placebo-Controlled Clinical Study [Corrigendum].",[This corrects the article DOI: 10.2147/DMSO.S169925.].,2020,[This corrects the article DOI: 10.2147/DMSO.S169925.].,['Overweight and Preobese Subjects'],['Placebo'],['Abdominal Fat'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}]",,0.249468,[This corrects the article DOI: 10.2147/DMSO.S169925.].,[],"Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S260832']
3593,32494184,Efficacy and Safety of Evocalcet Evaluated by Dialysate Calcium Concentration in Patients with Secondary Hyperparathyroidism Undergoing Hemodialysis.,"Purpose
Evocalcet is a novel oral calcimimetic drug that has demonstrated similar efficacy to cinacalcet in regulating serum parathyroid hormone (PTH), calcium, and phosphate levels, with fewer upper gastrointestinal tract-related adverse drug reactions (ADRs) in patients with secondary hyperparathyroidism undergoing hemodialysis in Japan. We investigated the efficacy and safety of once-daily oral evocalcet under different dialysate calcium concentrations.
Patients and Methods
A post hoc analysis by dialysate calcium concentration (2.5, 2.75, and 3.0 mEq/L) was performed using data from a previous Phase 3 study that included cinacalcet as an active control. Efficacy endpoints were the proportion of patients who achieved the target intact PTH levels of ≥60 and ≤240 pg/mL between Week 28 and Week 30; time-course changes in serum intact PTH; calcium and phosphorus levels, bone turnover markers, and fibroblast growth factor 23 (FGF23) over the 30-week study period. Safety endpoints were overall ADRs and hypocalcemia- and upper gastrointestinal tract-related ADRs.
Results
A total of 634 patients were included in the analysis. Levels of intact PTH, calcium, phosphate, bone turnover markers, and FGF23 showed improvement in all sub-groups, irrespective of dialysate calcium concentration. The incidence of upper gastrointestinal tract-related ADRs was significantly lower in the evocalcet group than the cinacalcet group with dialysate calcium concentrations of 2.75 and 3.0 mEq/L ( p <0.05 for both concentrations).
Conclusion
Evocalcet was effective and safe in regulating the levels of serum intact PTH, calcium, and phosphate in patients with secondary hyperparathyroidism undergoing hemodialysis, irrespective of dialysate calcium concentration.",2020,"Levels of intact PTH, calcium, phosphate, bone turnover markers, and FGF23 showed improvement in all sub-groups, irrespective of dialysate calcium concentration.","['patients with secondary hyperparathyroidism undergoing hemodialysis, irrespective of dialysate calcium concentration', 'A total of 634 patients were included in the analysis', 'Patients with Secondary Hyperparathyroidism Undergoing Hemodialysis', 'patients with secondary hyperparathyroidism undergoing hemodialysis in Japan']",['Evocalcet Evaluated by Dialysate Calcium Concentration'],"['Efficacy and Safety', 'target intact PTH levels', 'Levels of intact PTH, calcium, phosphate, bone turnover markers, and FGF23', 'efficacy and safety', 'time-course changes in serum intact PTH; calcium and phosphorus levels, bone turnover markers, and fibroblast growth factor 23 (FGF23', 'incidence of upper gastrointestinal tract-related ADRs', 'overall ADRs and hypocalcemia- and upper gastrointestinal tract-related ADRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C4519114', 'cui_str': 'evocalcet'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}]",634.0,0.0381748,"Levels of intact PTH, calcium, phosphate, bone turnover markers, and FGF23 showed improvement in all sub-groups, irrespective of dialysate calcium concentration.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Nephrology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Asada', 'Affiliation': 'Medical Affairs Department, Kyowa Kirin Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Endo', 'Affiliation': 'R&D Division, Kyowa Kirin Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takehisa', 'Initials': 'T', 'LastName': 'Kawata', 'Affiliation': 'Medical Affairs Department, Kyowa Kirin Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Fukagawa', 'Affiliation': 'Division of Nephrology, Endocrinology, and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}]",International journal of nephrology and renovascular disease,['10.2147/IJNRD.S243210']
3594,32494186,Effect of 8-Week Aerobic Walking Program on Sexual Function in Women with Rheumatoid Arthritis.,"Introduction
Sexual dysfunction is a little-addressed condition in patients with rheumatoid arthritis. Aerobic exercises, including walking, can help alleviate this dysfunction. This study aimed to determine the effect of an 8-week aerobic walking program on sexual function ine patients with rheumatoid arthritis.
Methodology
This clinical trial was conducted on 51 patients with rheumatoid arthritis. At first, patients were selected through nonprobability sampling. They were then allocated into intervention and control groups using block randomization. The walking intervention was performed based on the frequency-intensity-time-type principle forg 8 consecutive weeks. Rosen's Female Sexual Function Index was used for data collection before, immediately after, and 4 weeks after the intervention. Data collected were analyzed with SPSS 22 using descriptive and inferential statistics and 95% CI.
Findings
Mean sexual function scores before, after, and 4 weeks after intervention were 17.66±4, 22.88±4.7, and 24.39±5.1 in the intervention group and 17.60±4.24, 17.27±4.66, and 17.39±4.39 in the control group, respectively. Test results showed a significant intergroup difference in mean sexual function score ( p <0.05).
Conclusion
Based on our results, an 8-week aerobic walking program is recommended as an effective way to improve sexual function in women with rheumatoid arthritis.",2020,"Test results showed a significant intergroup difference in mean sexual function score ( p <0.05).
","['patients with rheumatoid arthritis', '51 patients with rheumatoid arthritis', 'women with rheumatoid arthritis', 'Women with Rheumatoid Arthritis']","['Aerobic exercises', '8-Week Aerobic Walking Program', 'aerobic walking program']","['mean sexual function score', 'sexual function', 'Sexual Function', 'Mean sexual function scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",51.0,0.0170113,"Test results showed a significant intergroup difference in mean sexual function score ( p <0.05).
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': 'Department of Nursing, School of Nursing, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Mohammadhossini', 'Affiliation': 'Department of Nursing, School of Nursing, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Karimi', 'Affiliation': 'Department of Operating Room, School of Paramedicine, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Yazdanpanah', 'Affiliation': 'Physical Medicine and Rehabilitation, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zarei Nezhad', 'Affiliation': 'Rheumatology, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Ghafarian Shirazi', 'Affiliation': 'Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}]",International journal of general medicine,['10.2147/IJGM.S252591']
3595,32494188,Comparison of Effectiveness of Ropivacaine Infusion Regimens for Continuous Femoral Nerve Block for Recovery After Total Knee Arthroplasty: A Randomized Double-Blind Trial.,"Purpose
Continuous femoral nerve block (cFNB) is effective for analgesia after total knee arthroplasty (TKA). However, it is not clear which low-dose regimen of ropivacaine infusion for cFNB provides adequate analgesia and enables rapid recovery. The aim of this study was to compare the effects of different cFNB regimens on rehabilitation of patients after TKA.
Patients and Methods
Sixty patients scheduled for TKA were enrolled in this trial. After surgery, patients in the 0.1%, 0.15%, and 0.2% groups received infusion of 10 mL of 0.1%, 6.7 mL of 0.15%, and 5 mL of 0.2% ropivacaine per hour, respectively (n=20), at the dose of 10 mg/h for 48 h. The primary endpoint was time to readiness for discharge. The secondary endpoints were time to first walk, manual muscle testing (MMT) scores, numerical rating scale (NRS) scores at rest and movement, morphine consumption, rescue analgesia, and the incidence of adverse events.
Results
The time to readiness for discharge and the time to first walk of the 0.1% group were significantly longer than that of the 0.15% and 0.2% groups. MMT scores of the 0.2% group at 18 h after surgery were significantly lower than those of the 0.1% group. MMT scores of the 0.2% group at 24 and 48 h after surgery were also significantly lower than those of the 0.1% and 0.15% groups. NRS scores at rest and at movement in the 0.1% group were significantly higher than those in the 0.15% and 0.2% groups.
Conclusion
Patients administered the regimens of 0.15% and 0.2% ropivacaine infusion for cFNB were ready for discharge earlier than the 0.1% group after TKA, at the dose of 10 mg/h for 48 h. The regimen of 0.15% ropivacaine, which is associated with less quadriceps muscle strength weakness than 0.2%, is recommended for postoperative analgesia after TKA.",2020,"NRS scores at rest and at movement in the 0.1% group were significantly higher than those in the 0.15% and 0.2% groups.
","['analgesia after total knee arthroplasty (TKA', 'After Total Knee Arthroplasty', 'Patients and Methods\n\n\nSixty patients scheduled for TKA were enrolled in this trial', 'patients after TKA']","['Continuous femoral nerve block (cFNB', 'ropivacaine', 'Ropivacaine', 'cFNB regimens']","['MMT scores', 'quadriceps muscle strength weakness', 'time to first walk, manual muscle testing (MMT) scores, numerical rating scale (NRS) scores at rest and movement, morphine consumption, rescue analgesia, and the incidence of adverse events', 'time to readiness for discharge', 'time to readiness for discharge and the time to first walk', 'NRS scores']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0419511', 'cui_str': 'Age when first walked'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}]",60.0,0.163167,"NRS scores at rest and at movement in the 0.1% group were significantly higher than those in the 0.15% and 0.2% groups.
","[{'ForeName': 'Yujian', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Liangyu', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Lvdan', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Quanguang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Kejian', 'Initials': 'K', 'LastName': 'Shi', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S247158']
3596,30446162,Ruining the surprise: The effect of safety information before extinction on return of fear.,"BACKGROUND AND OBJECTIVES
In psychoeducation before exposure treatment patients are sometimes provided with information about the (low) probability that the feared outcome would occur. Since it has been proposed in the literature that this might have adverse effects, the current study investigated the effect of providing participants with this type of safety information on return of fear.
METHOD
In an ABA-renewal paradigm, participants in the experimental group were instructed between acquisition and extinction that the probability of US-occurrence would be extremely small in the remainder of the experiment. Participants in the control group did not receive this information.
RESULTS
Less return of fear in US-expectancy ratings was observed in participants who received the safety information.
LIMITATIONS
We failed to find successful acquisition in the skin-conductance data, which prevented us from interpreting the results of this outcome measure.
CONCLUSIONS
These results suggest that providing safety information is not deleterious for the effects of exposure and can even be beneficial for its effects. However, further clinical research is needed.",2019,"Less return of fear in US-expectancy ratings was observed in participants who received the safety information.
",[],[],[],[],[],[],,0.0268919,"Less return of fear in US-expectancy ratings was observed in participants who received the safety information.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Scheveneels', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, KU Leuven, Leuven, Belgium. Electronic address: sara.scheveneels@kuleuven.be.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Boddez', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, KU Leuven, Leuven, Belgium; Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Toon', 'Initials': 'T', 'LastName': 'De Ceulaer', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hermans', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, KU Leuven, Leuven, Belgium.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2018.11.001']
3597,28757831,Cervical epidural puncture guided by fluoroscopy in comparison to acoustic signals: Clinical results.,"BACKGROUND AND AIM
The increasing cases of the cervical epidural but the practitioners in need for a new method to decrease the safety of the injection and to improve the learning curve of the trainee. Furthermore, it should replace the potentially hazards, conventional one, which is the fluoroscope. Acoustic signals were tested for this purpose.
METHODS
Thirty-two patients were assigned to have a cervical epidural for pain management using both acoustic signals and fluoroscopy simultaneously.
RESULTS
The incidence of success was 100% with no complications. Likewise, the decrease in fluoroscopy shots number was 70%.
CONCLUSIONS
Acoustic signals are a simple, effective method of cervical epidural insertion. It reduces the usage of fluoroscopy and can be used as a learning tool.",2017,The incidence of success was 100% with no complications.,['Thirty-two patients'],"['cervical epidural for pain management using both acoustic signals and fluoroscopy simultaneously', 'Cervical epidural puncture guided by fluoroscopy']","['fluoroscopy shots number', 'incidence of success']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",32.0,0.0349046,The incidence of success was 100% with no complications.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hm', 'Affiliation': 'Department of Anesthesia, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ymr', 'Initials': 'Y', 'LastName': 'Toble', 'Affiliation': 'Department of Anesthesia, National Cancer Institute Cairo University, Cairo, Egypt.'}, {'ForeName': 'Yya', 'Initials': 'Y', 'LastName': 'Tolba', 'Affiliation': 'Department of Anesthesia, Pain and Critical Care, King Faisal Specialist Hospital and Research Centre, National Cancer Institute Cairo University, Cairo, Egypt.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_52_17']
3598,31619300,The impact of surgical site infections on hospital contribution margin-a European prospective observational cohort study.,"BACKGROUND
Surgical site infections (SSIs) are common surgical complications that lead to increased costs. Depending on payer type, however, they do not necessarily translate into deficits for every hospital.
OBJECTIVE
We investigated how surgical site infections (SSIs) influence the contribution margin in 2 reimbursement systems based on diagnosis-related groups (DRGs).
METHODS
This preplanned observational health cost analysis was nested within a Swiss multicenter randomized controlled trial on the timing of preoperative antibiotic prophylaxis in general surgery between February 2013 and August 2015. A simulation of cost and income in the National Health Service (NHS) England reimbursement system was conducted.
RESULTS
Of 5,175 patients initially enrolled, 4,556 had complete cost and income data as well as SSI status available for analysis. SSI occurred in 228 of 4,556 of patients (5%). Patients with SSIs were older, more often male, had higher BMIs, compulsory insurance, longer operations, and more frequent ICU admissions. SSIs led to higher hospital cost and income. The median contribution margin was negative in cases of SSI. In SSI cases, median contribution margin was Swiss francs (CHF) -2045 (IQR, -12,800 to 4,848) versus CHF 895 (IQR, -2,190 to 4,158) in non-SSI cases. Higher ASA class and private insurance were associated with higher contribution margins in SSI cases, and ICU admission led to greater deficits. Private insurance had a strong increasing effect on contribution margin at the 10th, 50th (median), and 90th percentiles of its distribution, leading to overall positive contribution margins for SSIs in Switzerland. The NHS England simulation with 3,893 patients revealed similar but less pronounced effects of SSI on contribution margin.
CONCLUSIONS
Depending on payer type, reimbursement systems with DRGs offer only minor financial incentives to the prevention of SSI.",2019,"Patients with SSIs were older, more often male, had higher BMIs, compulsory insurance, longer operations, and more frequent ICU admissions.","['5,175 patients initially enrolled, 4,556 had', 'general surgery between February 2013 and August 2015', 'National Health Service (NHS']","['preoperative antibiotic prophylaxis', 'SSIs']","['median contribution margin', 'complete cost and income data', 'SSI', 'hospital cost and income']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}]",5175.0,0.0624104,"Patients with SSIs were older, more often male, had higher BMIs, compulsory insurance, longer operations, and more frequent ICU admissions.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'von Strauss', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Switzerland.'}, {'ForeName': 'Walter R', 'Initials': 'WR', 'LastName': 'Marti', 'Affiliation': 'Department of Surgery, Kantonsspital Aarau, Switzerland.'}, {'ForeName': 'Edin', 'Initials': 'E', 'LastName': 'Mujagic', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coslovsky', 'Affiliation': 'Clinical Trial Unit, University of Basel and University Hospital Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Diernberger', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, Scotland, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, Scotland, United Kingdom.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Zeindler', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Switzerland.'}, {'ForeName': 'Lilian A', 'Initials': 'LA', 'LastName': 'Salm', 'Affiliation': 'Department of Surgery, Kantonsspital Aarau, Switzerland.'}, {'ForeName': 'Savas D', 'Initials': 'SD', 'LastName': 'Soysal', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mechera', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'von Holzen', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Switzerland.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Weber', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Switzerland.'}]",Infection control and hospital epidemiology,['10.1017/ice.2019.273']
3599,30636569,Does State Dissociation Mediate the Relation Between Alcohol Intoxication and Deliberate Self-Harm?,"Research supports the notion that alcohol intoxication is a risk factor for deliberate self-harm (DSH). However, the underlying mechanisms for this relationship are poorly understood. We aimed to determine whether alcohol-induced dissociation mediated alcohol's effects on DSH. We used data from a dose-response study of alcohol intoxication and DSH to test the proposed model. Participants were assigned to reach target blood alcohol concentrations (BAC) ranging from 0.00% through 0.10% and then completed a behavioral measure of DSH. Dissociation was assessed using the Alcohol Dissociative Experiences Scale. BAC predicted both dissociation and DSH, but dissociation did not predict DSH. Although research on clinical populations suggests dissociation is related to DSH, our findings suggest dissociation does not mediate the effects of alcohol on self-harm.",2020,Participants were assigned to reach target blood-alcohol concentrations (BAC) ranging from 0.00% through 0.10% and then completed a behavioral measure of DSH.,[],[],"['blood-alcohol concentrations (BAC', 'Alcohol Dissociative Experiences Scale']",[],[],"[{'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C0887889', 'cui_str': 'BACs (Chromosomes)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0222045'}]",,0.024072,Participants were assigned to reach target blood-alcohol concentrations (BAC) ranging from 0.00% through 0.10% and then completed a behavioral measure of DSH.,"[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Timmins', 'Affiliation': 'Department of Psychology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Berman', 'Affiliation': 'Department of Psychology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Nadorff', 'Affiliation': 'Department of Psychology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Amadi', 'Affiliation': 'Department of Psychology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Fanning', 'Affiliation': 'The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'McCloskey', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2018.1563577']
3600,31333364,Cost drain of anesthesia emergency drugs in a quaternary care hospital.,"Background
Anesthesiologists draw up a selection of drugs for emergency use at the start of their list; unused drugs are discarded at the end of the list, to prevent contamination and spread of infections. We audited the practice in our department to evaluate the scale and cost impact of anesthesia emergency drugs wastage.
Subjects and Methods
A questionnaire was randomly given to anesthesiologists in our department, working in some of the operating rooms in our main floor, every morning over 7 working days. Completed forms were collected at the end of respective lists.
Results
A total of 93 completed forms were returned. Ephedrine (96%) and phenyepherine (95%) were the most frequently drawn drugs; atropine (96%) and suxamthonium (92%) were the most frequently discarded drugs. Phenylepherine was the single most expensive item wasted, representing 160% of the cost of all other drugs wasted together, and the price of discarded ephedrine and phenylephrine together represented 3/4 th of the total wastage. Some practices carried room for rationalization, such as drawing up of atropine and glycopyrolate simultaneously, of both the vasopressors in patients unsuspected for developing significant hypotension, or of suxamethonium in a patient planned to be intubated and postoperative ventilation.
Conclusion
Significant savings may be realized through switching to prefilled syringes, making protocols available for rational use of emergency drugs, and safe pooling of expensive drugs between adjacent operating rooms, in an anesthesia department.",2019,"Phenylepherine was the single most expensive item wasted, representing 160% of the cost of all other drugs wasted together, and the price of discarded ephedrine and phenylephrine together represented 3/4 th of the total wastage.",[],"['phenyepherine', 'Phenylepherine', 'suxamethonium', 'atropine', 'Ephedrine']",[],[],"[{'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}]",[],93.0,0.0296937,"Phenylepherine was the single most expensive item wasted, representing 160% of the cost of all other drugs wasted together, and the price of discarded ephedrine and phenylephrine together represented 3/4 th of the total wastage.","[{'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Majeed', 'Affiliation': 'King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Attyia', 'Initials': 'A', 'LastName': 'Firdous', 'Affiliation': 'King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'AlBabtain', 'Affiliation': 'King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Iqbal', 'Affiliation': 'King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_706_18']
3601,30688399,The other serelaxin in acute heart failure study: lessons from a pragmatic clinical trial.,,2019,,[],['serelaxin'],[],[],[{'cui': 'C3700393'}],[],,0.0735132,,"[{'ForeName': 'Andreas P', 'Initials': 'AP', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, MS, USA.'}]",European journal of heart failure,['10.1002/ejhf.1416']
3602,31007683,Retraction: Dexmedetomidine in a surgically inserted catheter for transversus abdominis plane block in donor hepatectomy: A prospective randomized controlled study.,"[This retracts the article on p. 297 in vol. 12, PMID: 29628844.].",2019,"[This retracts the article on p. 297 in vol. 12, PMID: 29628844.].",['donor hepatectomy'],['Retraction: Dexmedetomidine'],[],"[{'cui': 'C0411259', 'cui_str': 'Removal of liver from donor (procedure)'}]","[{'cui': 'C0332523', 'cui_str': 'Retraction (finding)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.0331739,"[This retracts the article on p. 297 in vol. 12, PMID: 29628844.].",[],Saudi journal of anaesthesia,['10.4103/1658-354X.254540']
3603,31094235,"Letter to the Editor RE: Srougi et al., Septic Shock Following Surgical Decompression of Obstructing Ureteral Stones: A Prospective Analysis (From: Srougi V, Moscardi PR, Marchini GS, et al. J Endourol 2017;32:446-450; DOI: 10.1089/end.2017.0896).",,2019,,[],['Surgical Decompression of Obstructing Ureteral Stones'],[],[],"[{'cui': 'C0376530', 'cui_str': 'Decompression, Surgical'}, {'cui': 'C0549186', 'cui_str': 'Obstructed (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}]",[],,0.0176317,,"[{'ForeName': 'Koo Han', 'Initials': 'KH', 'LastName': 'Yoo', 'Affiliation': 'Department of Urology, Stanford University Medical Center, Stanford, California.'}, {'ForeName': 'Gyeong Eun', 'Initials': 'GE', 'LastName': 'Min', 'Affiliation': 'Department of Urology, Stanford University Medical Center, Stanford, California.'}, {'ForeName': 'Hyung-Lae', 'Initials': 'HL', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, School of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, Stanford University Medical Center, Stanford, California.'}]",Journal of endourology,['10.1089/end.2019.0128']
3604,31296590,Renal denervation therapy for hypertension: still on trial.,,2019,,['hypertension'],['Renal denervation therapy'],[],"[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0155365,,"[{'ForeName': 'Iain McGregor', 'Initials': 'IM', 'LastName': 'MacIntyre', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David John', 'Initials': 'DJ', 'LastName': 'Webb', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-315255']
3605,30891610,Surgical Performance Determines Functional Outcome Benefit in the Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) Procedure.,"BACKGROUND
Minimally invasive surgery procedures, including stereotactic catheter aspiration and clearance of intracerebral hemorrhage (ICH) with recombinant tissue plasminogen activator hold a promise to improve outcome of supratentorial brain hemorrhage, a morbid and disabling type of stroke. A recently completed Phase III randomized trial showed improved mortality but was neutral on the primary outcome (modified Rankin scale score 0 to 3 at 1 yr).
OBJECTIVE
To assess surgical performance and its impact on the extent of ICH evacuation and functional outcomes.
METHODS
Univariate and multivariate models were used to assess the extent of hematoma evacuation efficacy in relation to mRS 0 to 3 outcome and postulated factors related to patient, disease, and protocol adherence in the surgical arm (n = 242) of the MISTIE trial.
RESULTS
Greater ICH reduction has a higher likelihood of achieving mRS of 0 to 3 with a minimum evacuation threshold of ≤15 mL end of treatment ICH volume or ≥70% volume reduction when controlling for disease severity factors. Mortality benefit was achieved at ≤30 mL end of treatment ICH volume, or >53% volume reduction. Initial hematoma volume, history of hypertension, irregular-shaped hematoma, number of alteplase doses given, surgical protocol deviations, and catheter manipulation problems were significant factors in failing to achieve ≤15 mL goal evacuation. Greater surgeon/site experiences were associated with avoiding poor hematoma evacuation.
CONCLUSION
This is the first surgical trial reporting thresholds for reduction of ICH volume correlating with improved mortality and functional outcomes. To realize the benefit of surgery, protocol objectives, surgeon education, technical enhancements, and case selection should be focused on this goal.",2019,Mortality benefit was achieved at ≤30,[],"['Minimally Invasive Surgery', 'recombinant tissue plasminogen activator', 'stereotactic catheter aspiration', 'Plus Recombinant Tissue Plasminogen Activator']","['Mortality benefit', 'mortality']",[],"[{'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0918038,Mortality benefit was achieved at ≤30,"[{'ForeName': 'Issam A', 'Initials': 'IA', 'LastName': 'Awad', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Polster', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Carrión-Penagos', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Stadnik', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Patricia Lynn', 'Initials': 'PL', 'LastName': 'Money', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, Ohio.'}, {'ForeName': 'Maged D', 'Initials': 'MD', 'LastName': 'Fam', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Koskimäki', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Romuald', 'Initials': 'R', 'LastName': 'Girard', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lane', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Nichol', 'Initials': 'N', 'LastName': 'McBee', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Ziai', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dodd', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Carlson', 'Affiliation': 'Department of Neurosurgery, University of New Mexico School of Medicine, Albuquerque, New Mexico.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Camarata', 'Affiliation': 'Department of Neurosurgery, University of Kansas School of Medicine, Kansas City, Kansas.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Caron', 'Affiliation': 'Department of Neurosurgery, University of Texas, San Antonio, Texas.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Harrigan', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Gregson', 'Affiliation': 'Neurosurgical Trials Group, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'A David', 'Initials': 'AD', 'LastName': 'Mendelow', 'Affiliation': 'Neurosurgical Trials Group, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zuccarello', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, Ohio.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurosurgery,['10.1093/neuros/nyz077']
3606,31388905,"Capsule Commentary on Satre et al., ""Interventions to Reduce Unhealthy Alcohol Use among Primary Care Patients with HIV: the Health and Motivation Randomized Clinical Trial"".",,2019,,['Primary Care Patients with HIV'],['Interventions'],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",[],[],,0.0480839,,"[{'ForeName': 'Lori D', 'Initials': 'LD', 'LastName': 'Karan', 'Affiliation': 'Internal Medicine and Preventive Medicine, Loma Linda University Medical School, Loma Linda, USA. lori.karan@gmail.com.'}]",Journal of general internal medicine,['10.1007/s11606-019-05171-8']
3607,29067219,Driving with Hemianopia V: Do Individuals with Hemianopia Spontaneously Adapt Their Gaze Scanning to Differing Hazard Detection Demands?,"PURPOSE
We investigated whether people with homonymous hemianopia (HH) were able to spontaneously (without training or instructions) adapt their blind-side scan magnitudes in response to differing scanning requirements for detection of pedestrians in a driving simulator when differing cues about pedestrian eccentricities and movement behaviors were available in the seeing hemifield.
METHODS
Twelve HH participants completed two sessions in a driving simulator pressing the horn when they detected a pedestrian. Stationary pedestrians outside the driving lane were presented in one session and approaching pedestrians on a collision course in the other. Gaze data were analyzed for pedestrians initially appearing at approximately 14° in the blind hemifield. No instructions were given regarding scanning.
RESULTS
After appearing, the stationary pedestrians' eccentricity increased rapidly to a median of 31° after 2.5 seconds, requiring increasingly larger blind-side gaze scans for detection, while the approaching pedestrians' eccentricity remained constant at approximately 14°, requiring a more moderate scan (∼14°) for detection. Although median scan magnitudes did not differ between the two conditions (approaching: 14° [IQR 9°-15°]; stationary: 13° [IQR 9°-20°]; P = 0.43), three participants showed evidence of adapting (increasing) their blind-side scan magnitudes in the stationary condition.
CONCLUSIONS
Three participants (25%) appeared to be able to apply voluntary cognitive control to modify their blind-side gaze scanning in response to the differing scanning requirements of the two conditions without explicit training.
TRANSLATIONAL RELEVANCE
Our results suggest that only a minority of people with hemianopia are likely to be able to spontaneously adapt their blind-side scanning in response to rapidly changing and unpredictable situations in on-road driving.",2017,"Although median scan magnitudes did not differ between the two conditions (approaching: 14° [IQR 9°-15°]; stationary: 13° [IQR 9°-20°]; P = 0.43), three participants showed evidence of adapting (increasing) their blind-side scan magnitudes in the stationary condition.
","['Twelve HH participants', 'people with homonymous hemianopia (HH']",['Hemianopia V'],"['Gaze data', 'median scan magnitudes']","[{'cui': 'C0271202', 'cui_str': 'Hemianopsia, Homonymous'}]","[{'cui': 'C0018979', 'cui_str': 'Hemianopia'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}]",12.0,0.07115,"Although median scan magnitudes did not differ between the two conditions (approaching: 14° [IQR 9°-15°]; stationary: 13° [IQR 9°-20°]; P = 0.43), three participants showed evidence of adapting (increasing) their blind-side scan magnitudes in the stationary condition.
","[{'ForeName': 'Concetta F', 'Initials': 'CF', 'LastName': 'Alberti', 'Affiliation': 'Department of Psychology, College of Science, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Goldstein', 'Affiliation': 'Schepens Eye Research Institute, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Peli', 'Affiliation': 'Schepens Eye Research Institute, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Bowers', 'Affiliation': 'Schepens Eye Research Institute, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA.'}]",Translational vision science & technology,['10.1167/tvst.6.5.11']
3608,31007682,Retraction: Digital assistance of nasogastric tube insertion in intubated patients under general anesthesia: A single-blinded prospective randomized study.,"[This retracts the article on p. 283 in vol. 11, PMID: 28757827.].",2019,[This retracts the article on p. 283 in vol.,['intubated patients under general anesthesia'],['nasogastric tube insertion'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0204819', 'cui_str': 'Intubation, Nasogastric'}]",[],,0.0285932,[This retracts the article on p. 283 in vol.,[],Saudi journal of anaesthesia,['10.4103/1658-354X.254539']
3609,31054784,"Re: Jürgen E. Gschwend, Matthias M. Heck, Jan Lehmann, et al. Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial. Eur Urol 2019;75:604-11.",,2019,,['Bladder Cancer Patients'],['Radical Cystectomy'],[],"[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]",[],,0.0645359,,"[{'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Taguchi', 'Affiliation': 'Department of Urology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Urology, Teikyo University School of Medicine, Tokyo, Japan. Electronic address: tohru-tky@umin.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Urology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}]",European urology,['10.1016/j.eururo.2019.04.031']
3610,31006014,Low on-treatment diastolic blood pressure is not independently associated with increased cardiovascular risk: an analysis of the SPRINT trial.,,2019,,[],[],['cardiovascular risk'],[],[],"[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0434101,,"[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Sobieraj', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw, Banacha 1a, 02-097 Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Lewandowski', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw, Banacha 1a, 02-097 Warsaw, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Siński', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw, Banacha 1a, 02-097 Warsaw, Poland.'}]",European heart journal,['10.1093/eurheartj/ehz225']
3611,31311741,The effectiveness of discharge planning stroke patient due to hypertension to improve patient satisfaction and independence.,"OBJECTIVE
To find out how important discharge planning program influence of satisfaction and independency stroke patients due to hypertension. Discharge planning is important for continuity of care and treatment during the patient hospitalized and after going home.
METHOD
This study Quasi-experimental method was used, pre and post-test for control group and intervention group with 160 respondent, 33 respondent pre and post 33 respondent for control group, and 33 respondent pre and 37 respondent post for intervention group, then 24 respondent observed start from hospitalized until discharge from hospital for patient independency.
RESULTS
The result of the study show that the satisfaction compares between control group meaningless significant, but satisfaction compare pre and post-test between intervention group very strong significant, but while comparing between control and intervention group, it does not significant. Meanwhile, patient independency strong significant while discharge planning programs applied.
CONCLUSIONS
It is concluded that discharge planning is necessary to be implemented for stroke patient and used by the healthcare team to perform the care and treatment.",2019,"The result of the study show that the satisfaction compares between control group meaningless significant, but satisfaction compare pre and post-test between intervention group very strong significant, but while comparing between control and intervention group, it does not significant.",['independency stroke patients due to hypertension'],[],[],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",[],[],,0.0199933,"The result of the study show that the satisfaction compares between control group meaningless significant, but satisfaction compare pre and post-test between intervention group very strong significant, but while comparing between control and intervention group, it does not significant.","[{'ForeName': 'Sedia', 'Initials': 'S', 'LastName': 'Simbolon', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': 'Achir Yani S', 'Initials': 'AYS', 'LastName': 'Hamid', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: achir@ui.ac.id.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Mustikasari', 'Affiliation': 'Faculty of Nursing Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Besral', 'Affiliation': 'Faculty of Public Health Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.06.011']
3612,31831629,"Evidence versus advocacy, as related to radiofrequency denervation in the treatment of chronic low back pain and the MINT trials.","In 2017, JAMA: Journal of the American Medical Association published the results of the MINT trials, prospective research involving 681 patients, all of whom received exercise therapy for low back pain. Half of the patients were randomized to additionally receive radiofrequency denervation (RFD) treatment. 88% of patients completed the 3-month follow-up, and 77% completed the 12-month follow-up. In this context, RFD provided no added benefit over the baseline of exercise therapy. In 2018, five authors, all experts in pain medicine, published a 'Daring Discourse' article in the journal Regional Anesthesia and Pain Medicine ( RAPM ), criticizing the findings of the MINT trials. Although 3 of the 5 authors of the RAPM 'Daring Discourse' article reported in conflict of interest statements-as is appropriate-that they were consultants to corporations that produce RFD equipment, the authors failed to disclose that 4 of 5 are on the editorial board of RAPM and all 5 are current officers in the medical organization that owns RAPM : that is, the American Society of Regional Anesthesia and Pain Medicine. Noteworthy, there was no published response from the MINT trial investigators to the Daring Discourse criticisms, either in the aforementioned example or in downstream venues where some of the same Daring Discourse authors continued their widely disseminated criticisms of the JAMA /MINT trials report. We believe that these actions taken by the Daring Discourse authors and RAPM have unfairly tipped the scales in the evaluation and application of RFD treatment of low back pain. In our commentary, we discuss: (1) the challenges associated with using clinical trials to predict clinical efficacy, (2) appropriate and inappropriate uses of postpublication commentary on original research findings, (3) the use of inappropriate commentary (and related means) to alter clinical practice in the presence of contradictory research findings, and (4) potential conflicts of interest related to the authors' and Journal's publication of the unopposed MINT trials criticism.",2020,We believe that these actions taken by the Daring Discourse authors and RAPM have unfairly tipped the scales in the evaluation and application of RFD treatment of low back pain.,[],"['exercise therapy', 'radiofrequency denervation (RFD) treatment', 'JAMA /MINT']",[],[],"[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C1740811', 'cui_str': 'Radiofrequency denervation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],681.0,0.0441703,We believe that these actions taken by the Daring Discourse authors and RAPM have unfairly tipped the scales in the evaluation and application of RFD treatment of low back pain.,"[{'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Lanier', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic Minnesota, Rochester, Minnesota, USA lanier.william@mayo.edu.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Neal', 'Affiliation': 'Department of Anesthesiology, Virginia Mason Medical Center, Seattle, Washington, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2019-100647']
3613,31600006,High-power application is associated with shorter procedure time and higher rate of first-pass pulmonary vein isolation in ablation index-guided atrial fibrillation ablation.,"BACKGROUNDS
Ablation index (AI) is useful to complete circumferential pulmonary vein isolation (CPVI) for atrial fibrillation (AF), but the role of radiofrequency power in AI-guided CPVI remains to be elucidated.
METHODS
We investigated 60 patients with AF undergoing AI-guided CPVI (mean age, 66 ± 9 years; nonparoxysmal AF in 16). The first 40 patients were randomly assigned to low-power (LP; n = 20) and medium-power (MP; n = 20) groups and the following 20 patients to high-power (HP). In LP, radiofrequency (RF) application was done at 30 W at the anterior and 20 W at the posterior left atrial (LA) wall, while in MP, it was at 40 W at the anterior and 30 W at the posterior LA wall. In HP, 50 W was applied at the anterior, 40 W at posterior LA wall and 30 W on the esophagus. At each ablation point, target AI was 400 at the anterior, 360 at the posterior LA wall, and 260 on the esophagus.
RESULTS
The time to complete both-side CPVI was shortest in HP (median, 40 minutes, interquartile range [IQR], 28-63) followed by MP (58 [49-83] minutes, P = .008 vs HP) and LP (84 [72-93] minutes, P = .002 vs MP). Higher RF power application significantly increased first-pass isolation rate (55% in LP, 80% in MP and 85% in HP, P = .002) and decreased LA-PV reconnection rate (10% in LP, 8% in MP, and 0% in HP, P = .03).
CONCLUSION
In AI-guided PVI, the HP RF application can shorten the time to complete PVI with a high rate of first-pass isolation and a low rate of LA-PV reconnection.",2019,"Higher RF power application significantly increased first-pass isolation rate (55% in LP, 80% in MP and 85% in HP, P=0.002) and decreased LA-PV reconnection rate (10% in LP, 8% in MP and 0% in HP, P=0.03).
","['40 patients', '60 patients with AF undergoing AI-guided CPVI (mean age, 66±9 years; non-paroxysmal AF in 16']",[],"['time to complete both-side CPVI', 'LA-PV reconnection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]",,0.0393837,"Higher RF power application significantly increased first-pass isolation rate (55% in LP, 80% in MP and 85% in HP, P=0.002) and decreased LA-PV reconnection rate (10% in LP, 8% in MP and 0% in HP, P=0.03).
","[{'ForeName': 'Hideharu', 'Initials': 'H', 'LastName': 'Okamatsu', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Junjiro', 'Initials': 'J', 'LastName': 'Koyama', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Yoshirou', 'Initials': 'Y', 'LastName': 'Sakai', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Koudai', 'Initials': 'K', 'LastName': 'Negishi', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Katsuhide', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Takuo', 'Initials': 'T', 'LastName': 'Tsurugi', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14223']
3614,31604630,Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure to Prevent Primary Noninvasive Ventilation Failure in Extremely Low Birthweight Infants.,"Reducing the risk of primary noninvasive ventilation failure in extremely low birthweight infants is linked to reducing bronchopulmonary dysplasia. In a secondary analysis of randomized data, we identified that failure rates and time to failure were similar for nasal intermittent positive pressure ventilation vs nasal continuous positive airway pressure.",2020,"In a secondary analysis of randomized data, we identified that failure rates and time to failure were similar for nasal intermittent positive pressure ventilation vs nasal continuous positive airway pressure.","['extremely low birthweight infants', 'Extremely Low Birthweight Infants']","['nasal intermittent positive pressure ventilation vs nasal continuous positive airway pressure', 'Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure']",['failure rates and time to failure'],"[{'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'IPPV'}, {'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0940758,"In a secondary analysis of randomized data, we identified that failure rates and time to failure were similar for nasal intermittent positive pressure ventilation vs nasal continuous positive airway pressure.","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Bourque', 'Affiliation': 'Section of Neonatology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO. Electronic address: stephanie.bourque@childrenscolorado.org.'}, {'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Roberts', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Clyde J', 'Initials': 'CJ', 'LastName': 'Wright', 'Affiliation': 'Section of Neonatology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Haresh', 'Initials': 'H', 'LastName': 'Kirpalani', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Lemyre', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Millar', 'Affiliation': 'Department of Neonatology, Royal Maternity Hospital, Belfast, United Kingdom.'}, {'ForeName': 'Nicolas A', 'Initials': 'NA', 'LastName': 'Bamat', 'Affiliation': ""Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.08.064']
3615,31796480,"Design, development and randomised controlled trial of a smartphone application, 'QinTB', for smoking cessation in tuberculosis patients: study protocol.","INTRODUCTION
Providing smoking cessation treatment is an important intervention for tuberculosis (TB) patients. Mobile technologies, such as smartphone applications, have shown promising potential. However, there are few effective applications that could support TB patients in their efforts to quit smoking. To address this problem, we will develop a smartphone application 'QinTB' to help TB patients quit smoking, and we will evaluate the clinical efficacy of this application by using a randomised controlled trial (RCT).
METHODS AND ANALYSIS
This is a two-step study. In the first step, we will develop a smartphone application based on an interactive application of the transtheoretical model and protection motivation theory. Then, we will perform an RCT using a two-arm design; a total of 400 patients will be randomly assigned to the application group or the doctors' advice group; both treatments will be 6 months and follow-up will be 12 months; the primary outcome is the biochemically verified 6 month sustained abstinence rate; data will be analysed on an intention-to-treat basis.
ETHICS AND DISSEMINATION
This study was approved by the Ethics Committee of Beijing Research Institute for Tuberculosis Control and Prevention. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER
This study was registered in the Chinese Clinical Trial Registry (ChiCTR1900022008) and the stage is Pre-results.",2019,"In the first step, we will develop a smartphone application based on an interactive application of the transtheoretical model and protection motivation theory.","['400 patients', 'tuberculosis (TB) patients', 'tuberculosis patients']","[""smartphone application, 'QinTB""]",[],"[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],400.0,0.157364,"In the first step, we will develop a smartphone application based on an interactive application of the transtheoretical model and protection motivation theory.","[{'ForeName': 'Haoxiang', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Social Medicine and Health Education, School of Public Health, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'International Union Against Tuberculosis and Lung Disease, Paris, France.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Social Medicine and Health Education, School of Public Health, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Tobacco Medicine and Tobacco Cessation Center, China-Japan Friendship Hospital, Beijing, China changchun@bjmu.edu.cn lzlzq2004@126.com.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Department of Social Medicine and Health Education, School of Public Health, Peking University Health Science Center, Beijing, China changchun@bjmu.edu.cn lzlzq2004@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-031204']
3616,31698111,Changes in Dosing and Dose Timing of D-Cycloserine Explain Its Apparent Declining Efficacy for Augmenting Exposure Therapy for Anxiety-related Disorders: An Individual Participant-data Meta-analysis.,"The apparent efficacy of d-cycloserine (DCS) for enhancing exposure treatment for anxiety disorders appears to have declined over the past 14 years. We examined whether variations in how DCS has been administered can account for this ""declining effect"". We also investigated the association between DCS administration characteristics and treatment outcome to find optimal dosing parameters. We conducted a secondary analysis of individual participant data obtained from 1047 participants in 21 studies testing the efficacy of DCS-augmented exposure treatments. Different outcome measures in different studies were harmonized to a 0-100 scale. Intent-to-treat analyses showed that, in participants randomized to DCS augmentation (n = 523), fewer DCS doses, later timing of DCS dose, and lower baseline severity appear to account for this decline effect. More DCS doses were related to better outcomes, but this advantage leveled-off at nine doses. Administering DCS more than 60 minutes before exposures was also related to better outcomes. These predictors were not significant in the placebo arm (n = 521). Results suggested that optimal DCS administration could increase pre-to-follow-up DCS effect size by 50%. In conclusion, the apparent declining effectiveness of DCS over time may be accounted for by how it has been administered. Optimal DCS administration may substantially improve outcomes. Registration: The analysis plan for this manuscript was registered on Open Science Framework (https://osf.io/c39p8/).",2019,These predictors were not significant in the placebo arm (n = 521).,"['Anxiety-related Disorders', 'Registration', '1047 participants in 21 studies testing the efficacy of DCS-augmented exposure treatments']","['placebo', 'd-cycloserine (DCS']",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]",[],1047.0,0.10251,These predictors were not significant in the placebo arm (n = 521).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, USA. Electronic address: drosenfi@smu.edu.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Institute for Mental Health Research and Department of Psychology, The University of Texas, Austin, USA.'}, {'ForeName': 'Stefan G', 'Initials': 'SG', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Lorena Fernández', 'Initials': 'LF', 'LastName': 'de la Cruz', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rück', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Monzani', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pérez-Vigil', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Frumento', 'Affiliation': 'Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Rianne A', 'Initials': 'RA', 'LastName': 'de Kleine', 'Affiliation': 'Institute of Psychology, Leiden University, The Netherlands.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Difede', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, NY, USA.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Farrell', 'Affiliation': 'School of Applied Psychology, Griffith University, Brisbane, Australia; Menzies Health Institute of Queensland, Brisbane, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Geller', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, USA; Harvard Medical School, Boston, USA.'}, {'ForeName': 'Maryrose', 'Initials': 'M', 'LastName': 'Gerardi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Guastella', 'Affiliation': 'Brain and Mind Research Institute, Central Clinical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Hendriks', 'Affiliation': 'Behavioral Science Institute, Radboud University Nijmegen, The Netherlands; Overwaal Center of Expertise for Anxiety Disorders OCD and PTSD, Institution for Integrated Mental Health Care Pro Persona, Nijmegen, the Netherlands.'}, {'ForeName': 'Matt G', 'Initials': 'MG', 'LastName': 'Kushner', 'Affiliation': 'Department of Psychiatry, University of Minnesota-Twin Cities, Minneapolis, USA.'}, {'ForeName': 'Francis S', 'Initials': 'FS', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, NY, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, USA.'}, {'ForeName': 'Cheri A', 'Initials': 'CA', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'McConnell', 'Affiliation': 'Menzies Health Institute of Queensland, Brisbane, Australia; School of Medicine, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Plag', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - University Medicine Berlin, Germany.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Pollack', 'Affiliation': 'Department of Psychiatry, Rush University Medical Center, Chicago, USA.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Ressler', 'Affiliation': 'Harvard Medical School, Boston, USA; McLean Hospital, Belmont, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Rodebaugh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - University Medicine Berlin, Germany.'}, {'ForeName': 'Candyce D', 'Initials': 'CD', 'LastName': 'Tart', 'Affiliation': 'New Mexico VA Health Care System, Albuquerque, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Tolin', 'Affiliation': 'The Institute of Living, Hartford, USA; Yale University School of Medicine, New Haven, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'van Minnen', 'Affiliation': 'Behavioral Science Institute, Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Waters', 'Affiliation': 'School of Applied Psychology, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Weems', 'Affiliation': 'Department of Human Development and Family Studies, Iowa State University, Ames, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, USA; Harvard Medical School, Boston, USA.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, NY, USA; City University of New York Graduate School of Public Health and Health Policy, New York, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Altemus', 'Affiliation': 'Yale University School of Medicine, New Haven, USA.'}, {'ForeName': 'Page', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Cukor', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, NY, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Finck', 'Affiliation': 'DRK Kliniken Berlin Wiegmann Klinik, Berlin, Germany.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Geffken', 'Affiliation': 'Geffken Group, PLLC, Gainesville, FL, USA.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Golfels', 'Affiliation': 'Woltersdorf Hospital, Woltersdorf, Germany.'}, {'ForeName': 'Wayne K', 'Initials': 'WK', 'LastName': 'Goodman', 'Affiliation': 'Department of Psychiatry, Baylor College of Medicine, USA.'}, {'ForeName': 'Cassidy A', 'Initials': 'CA', 'LastName': 'Gutner', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, USA.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Heyman', 'Affiliation': 'Great Ormond Street Hospital for Children, London, UK; University College, London, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Lewin', 'Affiliation': 'Department of Pediatrics, University of South Florida, Tampa, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, USA.'}, {'ForeName': 'Tanya K', 'Initials': 'TK', 'LastName': 'Murphy', 'Affiliation': 'Department of Pediatrics, University of South Florida, Tampa, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Norrholm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thuras', 'Affiliation': 'Department of Psychiatry, University of Minnesota-Twin Cities, Minneapolis, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'Primary Care Clinical Unit, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102149']
3617,31502945,User Experience Affects Dropout from Internet-Delivered Dialectical Behavior Therapy.,"Background: The emergence of computerized treatment may help reduce the gap between mental health treatment needs and accessibility, but unfortunately, dropout from these interventions is often high. Introduction: To increase the effectiveness of computerized interventions and reduce dropout, particularly among high-risk and clinically complex populations, better understanding of how usable and acceptable (i.e., user experience) these interventions are, informed by human computer interaction research, is needed. This study examines user experience of internet-delivered dialectical behavior therapy (iDBT). The major aim is to explore whether treatment dropout was affected by the complexity of population and/or user experience. Methods: Secondary analyses were conducted using data from a randomized controlled trial that evaluated iDBT in a sample of 59 suicidal and heavy episodic drinkers. Multivariate logistic regression and chi-square tests were performed to examine the roles of clinical characteristics and user experience in differentiating dropouts and nondropouts. Results: The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping. No clinical characteristics emerged as significant predictors of dropout. Discussion: The current results highlight technological problems as a possible barrier to adherence to computerized interventions. Future research would profit from increased integration of human-computer interaction to identify and solve user experience problems.",2020,"The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping.",['59 suicidal and heavy episodic drinkers'],"['iDBT', 'internet-delivered dialectical behavior therapy (iDBT']",[],"[{'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker (finding)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}]",[],59.0,0.0343292,"The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping.","[{'ForeName': 'Chelsey R', 'Initials': 'CR', 'LastName': 'Wilks', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Yin', 'Affiliation': 'Department of Psychology, Eastern Michigan University, Ypsilanti, Michigan, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Zuromski', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0124']
3618,31539072,Effect of the iExaminer Teaching Method on Fundus Examination Skills: A Randomized Clinical Trial.,,2019,,[],['iExaminer Teaching Method'],['Fundus Examination Skills'],[],"[{'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]","[{'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]",,0.106213,,"[{'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Shikino', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Hirota', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kikukawa', 'Affiliation': 'Department of Medical Education, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masatomi', 'Initials': 'M', 'LastName': 'Ikusaka', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11891']
3619,31870306,Measuring fidelity of delivery of the Community Occupational Therapy in Dementia-UK intervention.,"BACKGROUND
Interpreting data about intervention effectiveness requires an understanding of which intervention components were delivered and whether they were delivered as planned (fidelity of delivery). These studies aimed to develop a reliable measure for assessing fidelity of delivery of the Community Occupational Therapy in Dementia-UK intervention (COTiD-UK) (Study 1) and measure fidelity of delivery of COTiD-UK across sessions, sites and occupational therapists (Study 2).
METHODS
The studies used a longitudinal observational design nested within a multi-site randomised controlled trial. Where practicable, all intervention sessions were audio-recorded. Fidelity checklists and coding guidelines were developed, piloted and refined until good agreement was achieved between two coders. Ten percent of sessions were purposively sampled from 12 sites and 31 occupational therapists. Transcripts were coded using checklists developed in Study 1; 10% of sets of intervention session transcripts were double coded to ensure that agreement was maintained. Percentages of components that were delivered were calculated for each session, site and occupational therapist.
RESULTS
A reliable measure of fidelity of delivery for COTiD-UK was developed after several rounds of piloting and amendments. COTiD-UK was delivered with moderate fidelity across all six sessions (range: 52.4-75.5%). The mean range of fidelity varied across sites (26.7-91.2%) and occupational therapists (26.7-94.1%).
CONCLUSIONS
A reliable, systematic method for measuring fidelity of delivery of COTiD-UK was developed and applied, and can be adapted for use in similar interventions. As COTiD-UK was delivered with moderate fidelity, there is a reasonable degree of confidence that intervention effects were attributable to COTiD-UK.",2019,A reliable measure of fidelity of delivery for COTiD-UK was developed after several rounds of piloting and amendments.,['Dementia-UK intervention'],[],"['fidelity of delivery for COTiD-UK', 'mean range of fidelity']","[{'cui': 'C0497327', 'cui_str': 'Amentia'}]",[],"[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",,0.033941,A reliable measure of fidelity of delivery for COTiD-UK was developed after several rounds of piloting and amendments.,"[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Walton', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, UK. holly.walton@ucl.ac.uk.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Tombor', 'Affiliation': 'Department of Behavioural Science and Health, University College London, 1-19 Torrington Place, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Burgess', 'Affiliation': 'Research and Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Groarke', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Swinson', 'Affiliation': 'East Hertfordshire and Broxbourne Adult Disability Team, Hertfordshire County Council, Stevenage, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wenborn', 'Affiliation': 'Research and Development Department, Goodmayes Hospital, North East London NHS Foundation Trust, Essex, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Spector', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mountain', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}]",BMC geriatrics,['10.1186/s12877-019-1385-7']
3620,31498693,"Letter by Delmas et al Regarding Article, ""Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock: Matched-Pair IABP-SHOCK II Trial 30-Day Mortality Analysis"".",,2019,,['Acute Myocardial Infarction Complicated by Cardiogenic Shock'],[],[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}]",[],[],,0.0827502,,"[{'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Delmas', 'Affiliation': 'Intensive Cardiac Care Unit, Rangueil University Hospital, Toulouse, France (C.D.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Aix-Marseille University, APHM, Mediterranean Association for Research and Studies in Cardiology, Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Hopital Nord, Cardiology Department, Marseille, France (M.L., L.B.).'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bonello', 'Affiliation': 'Aix-Marseille University, APHM, Mediterranean Association for Research and Studies in Cardiology, Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Hopital Nord, Cardiology Department, Marseille, France (M.L., L.B.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041272']
3621,31498695,"Letter by O'Neill and Ohman Regarding Article, ""Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock: Matched-Pair IABP-SHOCK II Trial 30-Day Mortality Analysis"".",,2019,,['Acute Myocardial Infarction Complicated by Cardiogenic Shock'],[],[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}]",[],[],,0.0847539,,"[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': ""O'Neill"", 'Affiliation': ""Center for Structural Heart Disease, Henry Ford Hospital, Detroit, MI (W.W.O'N.).""}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Department of Medicine - Development and Innovation, Duke Heart Center, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (E.M.O.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.040831']
3622,31660788,A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein.,"INTRODUCTION
Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment.
METHODS
Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life.
RESULTS
A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20-54) mm vs. (GA alone) 56 (24-70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6-17.9) vs. 4.3 (IQR 2.7-7.9) P = 0.004).
CONCLUSION
The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39.",2020,,[],['perivenous tumescent anaesthesia'],[],[],"[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}]",[],,0.109432,,"[{'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Nandhra', 'Affiliation': 'Academic Vascular Surgery, Hull Royal Infirmary, Hull, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wallace', 'Affiliation': 'Academic Vascular Surgery, Hull Royal Infirmary, Hull, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'El-Sheikha', 'Affiliation': 'Academic Vascular Surgery, Hull Royal Infirmary, Hull, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Carradice', 'Affiliation': 'Academic Vascular Surgery, Hull Royal Infirmary, Hull, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chetter', 'Affiliation': 'Academic Vascular Surgery, Hull Royal Infirmary, Hull, UK.'}]",Phlebology,['10.1177/0268355519885221']
3623,30814028,Growth in HIV-1-exposed but uninfected infants treated with lopinavir-ritonavir versus lamivudine: a secondary analysis of the ANRS 12174 trial.,"BACKGROUND
The tolerance of antiretroviral drugs in infants must be carefully evaluated. In previous studies of children with HIV type 1 (HIV-1) less weight gain was observed in children given lopinavir-ritonavir-based combinations than those given nevirapine. We aimed to compare the effects of lopinavir-ritonavir and lamivudine on growth in HIV-exposed uninfected infants included in the ANRS 12174 trial.
METHODS
ANRS 12174 was a multicentre, randomised, controlled trial of infant prophylaxis to prevent HIV-1 transmission by breastfeeding done at four antenatal clinics in Burkina Faso, South Africa, Uganda, and Zambia. HIV-exposed uninfected infants born to asymptomatic mothers not eligible for antiretroviral therapy (CD4 count >350 cells per μL) were randomly assigned (1:1) to receive lopinavir-ritonavir or lamivudine 7 days after birth, with stratification by country. In a prespecified secondary analysis, we assessed the effect of lopinavir-ritonavir and lamivudine on the growth of these infants from day 7 until cessation of breastfeeding (maximum treatment time 12 months) in the modified intention-to-treat population, which included all children correctly enrolled with at least one follow-up anthropometric measurement. We compared the growth of infants, defined as children's WHO-defined length-for-age Z score (LAZ), weight-for-length Z score (WAZ), and weight-for-age Z score (WLZ). We used linear mixed effect and β spline-regression models to compare growth between the treatment groups. The trial is registered with ClinicalTrials.gov, number NCT00640263.
FINDINGS
1273 HIV-exposed uninfected infants and their mothers were enrolled between Nov 16, 2009, and May 7, 2013, of whom 1266 (99%) infants were included in the modified intention-to-treat analysis (630 assigned to lopinavir-ritonavir, 636 assigned to lamivudine). Baseline characteristics of the infants and mothers were similar across the two treatment groups. No differences in least-squares (LS) mean LAZ were identified between the treatment groups at any timepoint. LS mean WLZ was significantly lower in the lopinavir-ritonavir group than the lamivudine group at 26 weeks (difference -0·22 [95% CI -0·34 to -0·09], p=0·0006) and 50 weeks (-0·25 [-0·47 to -0·04], p=0·02). LS mean WAZ was also significantly lower in the lopinavir-ritonavir group than the lamivudine group at 26 weeks (difference -0·18 [95% CI -0·30 to -0·05], p=0·01) and 50 weeks (-0·24 [-0·45 to -0·05], p=0·02). Linear mixed models showed that lopinavir-ritonavir was associated with decreases in WLZ and WAZ over time (p<0·0001 and p=0·002), whereas spline regression models indicated that these reductions occurred early and remained constant thereafter (p<0·0001 with a knot at 44 days for WLZ; p=0·02 with a knot at 118 days for WAZ). The difference in LS mean WLZ at 50 weeks between the treatment groups was higher among girls than boys (difference -0·29 [95% CI -0·58 to 0·01], p=0·05 for girls; -0·22 [-0·53 to 0·09], p=0·18 for boys).
INTERPRETATION
Less weight gain was observed in infants given lopinavir-ritonavir than those given lamivudine, which is indicative of a persistent effect that could have long-term deleterious effects. This finding merits attention considering the recommendations for early and lifelong treatment of infants with HIV.
FUNDING
French National Agency for Research on AIDS and Viral Hepatitis, the Total Foundation, the European Developing Countries Clinical Trials Partnership, and the Research Council of Norway.",2019,"INTERPRETATION
Less weight gain was observed in infants given lopinavir-ritonavir than those given lamivudine, which is indicative of a persistent effect that could have long-term deleterious effects.","['infants from day 7 until cessation of breastfeeding (maximum treatment time 12 months) in the modified intention-to-treat population, which included all children correctly enrolled with at least one follow-up anthropometric measurement', '0·24', 'HIV-exposed uninfected infants included in the ANRS 12174 trial', 'HIV-exposed uninfected infants born to asymptomatic mothers not eligible for antiretroviral therapy (CD4 count >350 cells per μL', 'infants with HIV', 'ANRS 12174 was a multicentre, randomised, controlled trial of infant prophylaxis to prevent HIV-1 transmission by breastfeeding done at four antenatal clinics in Burkina Faso, South Africa, Uganda, and Zambia', 'p=0·05 for girls; -0·22 [-0·53 to 0·09], p=0·18 for boys', ""infants, defined as children's WHO-defined length-for-age Z score (LAZ), weight-for-length Z score (WAZ), and weight-for-age Z score (WLZ"", '1273 HIV-exposed uninfected infants and their mothers were enrolled between Nov 16, 2009, and May 7, 2013, of whom 1266 (99%) infants were included in the modified intention-to-treat analysis (630 assigned to']","['0·25', 'lamivudine', 'lopinavir-ritonavir and lamivudine', 'lopinavir-ritonavir', '0·18', 'nevirapine', 'lopinavir-ritonavir or lamivudine', 'lopinavir-ritonavir, 636 assigned to lamivudine']","['WLZ and WAZ', 'least-squares (LS) mean LAZ', 'weight gain', 'LS mean WLZ', 'LS mean WAZ']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.397927,"INTERPRETATION
Less weight gain was observed in infants given lopinavir-ritonavir than those given lamivudine, which is indicative of a persistent effect that could have long-term deleterious effects.","[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Blanche', 'Affiliation': 'Pediatric Immunology-Hematology and Rheumatology Unit, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France. Electronic address: stephane.blanche@aphp.fr.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Center for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Peries', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Université de Montpellier, Etablissement Français du Sang, Montpellier, France.'}, {'ForeName': 'Chipepo', 'Initials': 'C', 'LastName': 'Kankasa', 'Affiliation': 'Department of Pediatrics and Child Health, University Teaching Hospital, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Ingunn', 'Initials': 'I', 'LastName': 'Engebretsen', 'Affiliation': 'Center for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meda', 'Affiliation': 'Center of International Research for Health, Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Tumwine', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mandisa', 'Initials': 'M', 'LastName': 'Singata-Madliki', 'Affiliation': 'Effective Care Research Unit, Cecilia Makiwane Hospital, University of Fort Hare, East London, South Africa.'}, {'ForeName': 'Mwiya', 'Initials': 'M', 'LastName': 'Mwiya', 'Affiliation': 'Department of Pediatrics and Child Health, University Teaching Hospital, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van de Perre', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Université de Montpellier, Etablissement Français du Sang, Montpellier, France; Centre Hospitalo-Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Université de Montpellier, Etablissement Français du Sang, Montpellier, France; Centre Hospitalo-Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(18)30361-8']
3624,31648734,Patient-Centered Educational Resources for Atrial Fibrillation.,"Education has long been recognized as an important component of chronic condition management. Whereas education has been evaluated in atrial fibrillation (AF) populations as part of multifaceted interventions, it has never been tested as a single entity. The aim of this review is to describe the rationale for and role of education as part of comprehensive AF management. The development and use of educational material as part of the intervention of a randomized controlled trial, the HELP-AF (Home-Based Education and Learning Program in AF) study, will be described. This study was designed to determine the impact of a home-based structured educational program on outcomes in individuals with AF. An educational resource was developed to facilitate delivery of 4 key messages targeted at empowering individuals to self-manage their condition. The key messages focused on strategies for managing future AF episodes, the role of pharmacotherapy in the treatment of AF, the appropriate use of medicines to manage stroke risk and the role of cardiovascular risk factor management in AF. To support structured educational visiting, an educational booklet titled Living Well With Atrial Fibrillation (AF) was developed by a multidisciplinary team and was further refined following input from expert clinicians and patient interviews. Using a structured educational visiting approach, education was delivered by trained clinicians within the patient's home.",2019,An educational resource was developed to facilitate delivery of 4 key messages targeted at empowering individuals to self-manage their condition.,['individuals with AF'],"['home-based structured educational program', 'educational booklet titled Living']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]",[],,0.0255651,An educational resource was developed to facilitate delivery of 4 key messages targeted at empowering individuals to self-manage their condition.,"[{'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Gallagher', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia; Department of Cardiology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Rowett', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia; Drug and Therapeutics Information Service, Southern Adelaide Local Health Network, Adelaide, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nyfort-Hansen', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Simmons', 'Affiliation': 'Drug and Therapeutics Information Service, Southern Adelaide Local Health Network, Adelaide, Australia.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Brooks', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Moss', 'Affiliation': 'School of Public Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Middeldorp', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia; Department of Cardiology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Hendriks', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia; Department of Cardiology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Central Adelaide Local Health Network, Adelaide, Australia.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia; Department of Cardiology, Lyell McEwin Health Service, Adelaide, Australia.'}, {'ForeName': 'Dennis H', 'Initials': 'DH', 'LastName': 'Lau', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia; Department of Cardiology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia; Department of Cardiology, Royal Adelaide Hospital, Adelaide, Australia. Electronic address: prash.sanders@adelaide.edu.au.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.08.007']
3625,32085923,Whole Brain Radiotherapy Versus Stereotactic Radiosurgery in Poor-Prognosis Patients with One to 10 Brain Metastases: A Randomised Feasibility Study.,"AIMS
A significant proportion of patients with brain metastases have a poor prognosis, with a life expectancy of 3-6 months. To determine the optimal radiotherapeutic strategy for brain metastases in this population, we conducted a randomised feasibility study of whole brain radiotherapy (WBRT) versus stereotactic radiosurgery (SRS).
MATERIALS AND METHODS
Patients with a life expectancy of 3-6 months and between one and 10 brain metastases with a diameter ≤4 cm were enrolled at six Canadian cancer centres. Patients were randomly assigned (1:1) to receive either WBRT (20 Gy in five fractions) or SRS (15 Gy in one fraction). The primary end point was the rate of accrual per month. Secondary feasibility and clinical end points included the ratio of accrued subjects to screened subjects. This trial is registered with ClinicalTrials.gov (number NCT02220491).
RESULTS
In total, 210 patients were screened to enrol 22 patients into the trial; 20 patients were randomised between the two arms. Two patients did not receive treatment because one patient died and another patient withdrew consent after being enrolled. Patients were accrued between January 2015 and November 2017; the accrual rate was 0.63 patients/month. The most common reasons for exclusion were anticipated median survival outside the required range (n = 40), baseline Karnofsky Performance Score below 70 (n = 28) and more than 10 brain metastases (n = 28). The median follow-up was 7.0 months and the median survival was 7.0 months for all patients in the trial. The median intracranial progression-free survival was 1.8 months in the SRS arm and 9.2 months in the WBRT arm. There were five grade 3+ toxicities in the SRS arm and one grade 3+ toxicity in the WBRT arm; no grade 5 toxicities were observed. The cumulative rates of retreatment were 40% in the SRS arm and 40% in the WBRT arm.
CONCLUSIONS
A randomised trial evaluating WBRT versus SRS in patients with one to 10 metastases and a poor prognosis is feasible. A slower than expected accrual rate and difficulties with accurate prognostication were identified as issues in this feasibility study. A larger phase III randomised trial is planned to determine the optimal treatment in this patient population.",2020,"The cumulative rates of retreatment were 40% in the SRS arm and 40% in the WBRT arm.
","['Patients with a life expectancy of 3-6 months and between one and 10 brain metastases with a diameter ≤4 cm were enrolled at six Canadian cancer centres', 'Patients were accrued between January 2015 and November 2017; the accrual rate was 0.63 patients/month', 'patients with brain metastases', 'Poor-Prognosis Patients with One to 10 Brain Metastases', 'patients with one to 10 metastases', '210 patients were screened to enrol 22 patients into the trial; 20 patients']","['WBRT', 'whole brain radiotherapy (WBRT', 'stereotactic radiosurgery (SRS', 'Whole Brain Radiotherapy Versus Stereotactic Radiosurgery', 'WBRT (20 Gy in five fractions) or SRS']","['baseline Karnofsky Performance Score', 'grade 3+ toxicities', 'median intracranial progression-free survival', 'grade 5 toxicities', 'median survival', 'cumulative rates of retreatment', 'grade 3+ toxicity', 'rate of accrual per month']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517468', 'cui_str': '0.63'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]",20.0,0.115789,"The cumulative rates of retreatment were 40% in the SRS arm and 40% in the WBRT arm.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Raman', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mou', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna, British Columbia, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hsu', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Abbostford Centre, Abbotsford, British Columbia, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Valev', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Centre for the North, Prince George, British Columbia, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cheung', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Fraser Valley Centre, Surrey, British Columbia, Canada.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vallières', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Vancouver Island Centre, Vancouver Island, British Columbia, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'McKenzie', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Beaton', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rackley', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gondara', 'Affiliation': 'Department of Population Oncology, British Columbia Cancer Vancouver Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Department of Radiation Oncology, BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada. Electronic address: anichol@bccancer.bc.ca.'}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2020.02.001']
3626,31260872,Testosterone administration increases social discounting in healthy males.,"Although testosterone is thought to induce antisocial and aggressive behavior, research on social economic interactions has associated it with prosocial and affiliative behavior. Here, we investigated the effects of testosterone on social distance-dependent generosity in an economic discounting task where participants chose between selfish and generous alternatives. We administered testosterone gel or placebo to men in a double-blind, randomized design and measured how willing they were to share rewards with close and distant others. Across two studies (total n = 174), testosterone administration consistently increased social discounting, that is participants became more selfish, particularly with regard to distant others (vs. close others). This effect was not explained by testosterone-induced increases in social distance perception. Our findings provide causal evidence that-testosterone reduces generosity in human economic decision-making. Moreover, they suggest that the valuation and the perception of social distance are independently affected by testosterone.",2019,"Across two studies (total n = 174), testosterone administration consistently increased social discounting, that is participants became more selfish, particularly with regard to distant others (vs. close others).",['healthy males'],"['testosterone', 'testosterone gel or placebo', 'Testosterone']","['social distance perception', 'perception of social distance', 'social discounting']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.313474,"Across two studies (total n = 174), testosterone administration consistently increased social discounting, that is participants became more selfish, particularly with regard to distant others (vs. close others).","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; College of Psychology, Shenzhen University, Shenzhen, China. Electronic address: yinwu0407@gmail.com.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; College of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Zilioli', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, United States; Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, United States.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Child Development and Learning Science (Ministry of Education), Southeast University, Nanjing, China.'}, {'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Key Laboratory of Child Development and Learning Science (Ministry of Education), Southeast University, Nanjing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; College of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Philippe N', 'Initials': 'PN', 'LastName': 'Tobler', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Switzerland.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.06.013']
3627,32270717,"Re: Yildiz BP, Bayraktaroglu M, Gunen H. Bronchodilator efficacy of tiotropium/formoterol (18/12 μg once daily via a Discair inhaler), tiotropium alone (18 μg by Handihaler) or combined with formoterol (12 μg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD. Curr Med Res Opin. 2019;35(12):2187-2196.",,2020,,[],"['tiotropium/formoterol ', 'Discair inhaler),tiotropium alone (18\u2009μg by Handihaler) or combined with formoterol']",[],[],"[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",[],,0.201767,,"[{'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Kalemci', 'Affiliation': 'Medical Park Gebze Hospital, Gebze, Turkey.'}, {'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Sarihan', 'Affiliation': 'Manisa Sehir Hastanesi, Manisa City Hospital, Manisa, Turkey.'}, {'ForeName': 'Ahmet Bülent', 'Initials': 'AB', 'LastName': 'Kargı', 'Affiliation': 'Medical Park Gebze Hospital, Gebze, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Şimşek', 'Affiliation': 'Bursa Chest Disease Hospital, Yıldırım, Turkey.'}, {'ForeName': 'Arife', 'Initials': 'A', 'LastName': 'Zeybek', 'Affiliation': 'Muğla Sıtkı Koçman Üniversitesi, Mugla, Turkey.'}]",Current medical research and opinion,['10.1080/03007995.2020.1754184']
3628,31789898,"The effect of ropivacaine concentration on common peroneal nerve block duration using a fixed dose: A randomised, double-blind trial in healthy volunteers.","BACKGROUND
The effect of local anaesthetic concentration on peripheral nerve block duration is unclear. Recent clinical trials found nerve blocks of equivalent duration despite changing local anaesthetic concentration but with a fixed local anaesthetic dose. A criticism of these studies is that the local anaesthetic doses used were above the proposed local anaesthetic dose-duration ceiling level, masking any potential effect of different local anaesthetic concentrations on nerve block duration.
OBJECTIVE
We investigated the effect of local anaesthetic concentration on nerve block duration using a fixed local anaesthetic dose below the local anaesthetic dose-duration ceiling level. We hypothesised that changing local anaesthetic concentration would affect nerve block duration.
DESIGN
Randomised, double-blind trial.
SETTING
Single-centre, academic hospital.
PARTICIPANTS
Healthy volunteers.
INTERVENTIONS
Each participant received an ultrasound-guided common peroneal nerve block with a fixed dose of 10 mg of ropivacaine dissolved in either 2.5, 5, 10, 15 or 20 ml of 0.9% saline according to group allocation, yielding local anaesthetic concentrations of 4, 2, 1, 0.67 and 0.5 mg ml.
MAIN OUTCOME MEASURES
The primary outcome was duration of sensory block defined as altered or no sensitivity to a cold stimulus. The secondary outcome was duration of motor block defined as either paresis or paralysis. Intergroup differences were tested using one-way Analysis of variance .
RESULTS
All participants had sensory block, and 56 out of 60 participants had motor block. From the highest to the lowest concentration groups, mean ± SD sensory block durations were 13.1 ± 2.7, 13.4 ± 3.3, 12.6 ± 3.9, 10.4 ± 2.9 and 11.0 ± 2.1 h (P = 0.073), and mean ± SD motor block durations were 8.5 ± 2.0, 7.9 ± 3.0, 6.1 ± 3.1, 5.9 ± 3.5, 4.0 1.9 h (P = 0.002).
CONCLUSION
In contrast to our hypothesis, we found no changes in mean sensory nerve block duration. However, local anaesthetic dilution resulted in reduced motor block duration.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03326609.",2020,Recent clinical trials found nerve blocks of equivalent duration despite changing local anaesthetic concentration but with a fixed local anaesthetic dose.,"['Single-centre, academic hospital', 'All participants had sensory block, and 56 out of 60 participants had motor block', 'Healthy volunteers', 'healthy volunteers']","['ropivacaine concentration', 'ultrasound-guided common peroneal nerve block with a fixed dose of 10\u200amg of ropivacaine']","['motor block duration', 'mean\u200a±\u200aSD sensory block durations', 'duration of sensory block defined as altered or no sensitivity to a cold stimulus', 'duration of motor block defined as either paresis or paralysis', 'mean\u200a±\u200aSD motor block durations', 'mean sensory nerve block duration']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394743', 'cui_str': 'Local anesthetic common peroneal nerve block (procedure)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0030552', 'cui_str': 'Muscular Paresis'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}]",60.0,0.628002,Recent clinical trials found nerve blocks of equivalent duration despite changing local anaesthetic concentration but with a fixed local anaesthetic dose.,"[{'ForeName': 'Claus Behrend', 'Initials': 'CB', 'LastName': 'Christiansen', 'Affiliation': 'From the Department of Anaesthesiology, Nordsjællands Hospital, University of Copenhagen, Hillerød, Denmark (CBC, MHM, EM, CR, LHL, KHWL).'}, {'ForeName': 'Mikkel Herold', 'Initials': 'MH', 'LastName': 'Madsen', 'Affiliation': ''}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Mølleskov', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rothe', 'Affiliation': ''}, {'ForeName': 'Lars Hyldborg', 'Initials': 'LH', 'LastName': 'Lundstrøm', 'Affiliation': ''}, {'ForeName': 'Kai H W', 'Initials': 'KHW', 'LastName': 'Lange', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001112']
3629,32098545,Link between body weight changes and metabolic parameters in drugs naïve subjects with type 2 diabetes treated with canagliflozin monotherapy.,"OBJECTIVES
The aim of this study is to investigate the correlations between the changes of body weight and metabolic parameters during canagliflozin treatment.
METHODS
Drug naïve subjects with T2DM (n = 84) received canagliflozin monotherapy for 3 months. The subjects were divided into three groups with equal numbers of subjects (n = 28 each) according to the reductions of BMI levels; highest (group A), intermediate (group B), and lowest (group C) reductions. Changes of the metabolic parameters were compared between group A and group C. These two groups acted as a control of each other.
RESULTS
Significant reductions of BMI levels (-4.1%, p < 0.00001) were observed in group A, while, surprisingly, significant increases (+1.5%, p < 0.00001) were seen in group C. In these two groups, similar reductions of HbA1c, FBG, or HOMA-R, and increases of HOMA-B levels were observed. Significant reductions of TG levels (-18.6%) were seen only in group A. At baseline, HbA1c levels were significantly lower in group A versus group C (p < 0.03). In group A, significant correlations between the changes of BMI and those of HbA1c (R = 0.496) were seen. By contrast, in group C, significant negative correlations were observed between these parameters (R = -0.463).
CONCLUSIONS
These results suggest that certain populations treated with canagliflozin gained weight, though similar glycemic and beta-cell/insulin sensitivity enhancing properties were observed in comparison to those with efficient weight reductions. Those who lost more weight had better glycemic efficacy in group A. By contrast, those who gained more weight had better glycemic efficacy in group C. Distinct glucose-lowering mechanisms might be operating between these two groups. Involvement of some factors including glucagons and free fatty acids is hypothesized.",2020,"At baseline, HbA1c levels were significantly lower in group A versus group C (p<0.03).","['naïve subjects with T2DM (n=84) received', 'drugs naïve subjects with type 2 diabetes treated with']","['canagliflozin monotherapy', 'canagliflozin treatment']","['TG levels', 'BMI levels', 'glycemic efficacy', 'HbA1c levels', 'HbA1c, FBG or HOMA-R, and increases of HOMA-B levels', 'body weight and metabolic parameters']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0120316,"At baseline, HbA1c levels were significantly lower in group A versus group C (p<0.03).","[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kutoh', 'Affiliation': 'Division of Clinical Research, Biomedical Center , Tokyo, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Wada', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Gyoda General Hospital , Saitama, Japan.'}, {'ForeName': 'Alexandra N', 'Initials': 'AN', 'LastName': 'Kuto', 'Affiliation': 'Division of Clinical Research, Biomedical Center , Tokyo, Japan.'}, {'ForeName': 'Jyunka', 'Initials': 'J', 'LastName': 'Hayashi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Gyoda General Hospital , Saitama, Japan.'}, {'ForeName': 'Rumi', 'Initials': 'R', 'LastName': 'Kurihara', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Gyoda General Hospital , Saitama, Japan.'}]",Hospital practice (1995),['10.1080/21548331.2020.1732098']
3630,32122703,Effect of photobiomodulation on recovery from neurosensory disturbances after sagittal split ramus osteotomy: a triple-blind randomised controlled trial.,"We have investigated the effect of photobiomodulation on the recovery of neurosensory function of the lip and chin after bilateral sagittal split osteotomy (BSSO). Laser irradiation was applied with a GaAs diode laser (continuous wave 980nm wavelength, power 100mW, and energy density 12J/cm 2 ). It was maintained within a 0.5cm 2 area in a total of 12 points for 60seconds at each visit on each point. Unilateral extraoral contact photobiomodulation treatment was applied the day before operation and then on days 1, 3, 7, 14, 21, and 28 postoperatively. One side of the mandible was the intervention side and the other the control side. On the control side, the laser probe was turned off and placed on the chosen area. Neurosensory evaluations were made before and immediately after operation, and 30 days and 60 days postoperatively. Twenty-five patients were screened, and 18 who met the inclusion criteria were included in the study; 14 were women and the mean (SD) age was 23 (5) years. Analysis of the visual analogue scales for general sensibility, pain discrimination, directional discrimination, and 2-point discrimination showed a significant difference between the intervention and control sides after 30 days (p=0.0011, 0.0034, 0.0023, and 0.0160, respectively). The difference was also significant after 60 days (p=0.0001, 0.0002, 0.0003, and 0.0010, respectively). The thermal discrimination rate was significantly higher in the laser group than the control group 30 days after surgery (p=0.002), but after 60 days the difference was not significant (p=1.000). We found no side effects from the laser radiation during the two-month follow up. The results suggest that photobiomodulation accelerated the patients' improvement from neurosensory disturbance after BSSO.",2020,"The thermal discrimination rate was significantly higher in the laser group than the control group 30 days after surgery (p=0.002), but after 60 days the difference was not significant (p=1.000).","['lip and chin after bilateral sagittal split osteotomy (BSSO', 'Twenty-five patients were screened, and 18 who met the inclusion criteria were included in the study; 14 were women and the mean (SD) age was 23 (5) years', 'neurosensory disturbances after sagittal split ramus osteotomy']","['photobiomodulation', 'Laser irradiation was applied with a GaAs diode laser']","['thermal discrimination rate', 'visual analogue scales for general sensibility, pain discrimination, directional discrimination, and 2-point discrimination', 'Neurosensory evaluations', 'neurosensory disturbance']","[{'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0616096', 'cui_str': 'BSSO'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0061005', 'cui_str': 'gallium arsenide'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}]","[{'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",14.0,0.0671275,"The thermal discrimination rate was significantly higher in the laser group than the control group 30 days after surgery (p=0.002), but after 60 days the difference was not significant (p=1.000).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sharifi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Cranio Maxillofacial Research Center, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fekrazad', 'Affiliation': 'Department of Periodontology, Dental Faculty - Radiation Sciences Research Center, Laser Research Center in Medical Sciences, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Taheri', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Cranio Maxillofacial Research Center, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hamedta90@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kasaeian', 'Affiliation': 'Hematology-Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Tehran, Iran; Pars Advanced and Minimally Invasive Medical Manners Research Center, Pars Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Babaei', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Otolaryngology Research Center, Department of Otolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.02.005']
3631,26362259,Web-Based Intervention for Teachers of Elementary Students With ADHD: Randomized Controlled Trial.,"OBJECTIVE
To test the acceptability, satisfaction, and effectiveness of a web-based intervention for teachers of elementary school-aged children with ADHD.
METHOD
Elementary classroom teachers (N = 58), along with their students with ADHD, participated in a randomized controlled trial. The program consisted of six sessions that included evidence-based intervention strategies for reducing ADHD symptoms and impairment in the classroom setting. Teachers also had access to a moderated Discussion Board and an online ADHD coach. Questionnaire data were electronically collected from teachers and parents pre-intervention, post-intervention (6 weeks), and after an additional 6-week follow-up.
RESULTS
Intent-to-treat analyses found significant improvements based on teacher (but not parent) reports of core ADHD symptoms and impairment for the Teacher Help for ADHD treatment group. Teachers reported a high level of acceptability and satisfaction.
CONCLUSION
Web-based ADHD interventions have the potential to reduce the barriers to treatment utilization and implementation that are common problems for school-based ADHD interventions.",2019,The program consisted of six sessions that included evidence-based intervention strategies for reducing ADHD symptoms and impairment in the classroom setting.,"['Teachers of Elementary Students With ADHD', 'teachers of elementary school-aged children with ADHD', 'Elementary classroom teachers (N = 58), along with their students with ADHD']","['web-based intervention', 'Web-based ADHD interventions']","['high level of acceptability and satisfaction', 'acceptability, satisfaction, and effectiveness']","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",58.0,0.0886748,The program consisted of six sessions that included evidence-based intervention strategies for reducing ADHD symptoms and impairment in the classroom setting.,"[{'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Corkum', 'Affiliation': '1 Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Nezihe', 'Initials': 'N', 'LastName': 'Elik', 'Affiliation': '2 Mount Saint Vincent University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Pamela A C', 'Initials': 'PAC', 'LastName': 'Blotnicky-Gallant', 'Affiliation': '1 Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'McGonnell', 'Affiliation': '2 Mount Saint Vincent University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGrath', 'Affiliation': '1 Dalhousie University, Halifax, Nova Scotia, Canada.'}]",Journal of attention disorders,['10.1177/1087054715603198']
3632,31853633,Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting.,"INTRODUCTION
The aim of the study was to compare the effectiveness of cognitive behavioural therapy interventions for insomnia (CBT-I) to that of a sleep hygiene intervention in a randomized controlled design among shift workers. We also studied whether the features of shift work disorder (SWD) affected the results.
METHODS
A total of 83 shift workers with insomnia disorder were partially randomized into a group-based CBT-I, self-help CBT-I, or sleep hygiene control intervention. The outcomes were assessed before and after the interventions and at 6-month follow-up using questionnaires, a sleep diary, and actigraphy.
RESULTS
Perceived severity of insomnia, sleep-related dysfunctional beliefs, burnout symptoms, restedness, recovery after a shift, and actigraphy-based total sleep time improved after the interventions, but we found no significant differences between the interventions. Mood symptoms improved only among the group-based CBT-I intervention participants. Non-SWD participants had more mental diseases and symptoms, used more sleep-promoting medication, and had pronounced insomnia severity and more dysfunctional beliefs than those with SWD. After the interventions, non-SWD participants showed more prominent improvements than those with SWD.
CONCLUSIONS
Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the sleep hygiene control intervention. Alleviation of mood symptoms seemed to be the main added value of the group-based CBT-I intervention compared to the control intervention. The clinical condition of the non-SWD participants was more severe and these participants benefitted more from the interventions than the SWD participants did.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02523079.",2020,Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the sleep hygiene control intervention.,"['83 shift workers with insomnia disorder', 'insomnia among shift workers', 'shift workers']","['cognitive behavioural therapy interventions', 'CBT-I, self-help CBT-I, or sleep hygiene control intervention', 'Cognitive behavioural therapy interventions', 'sleep hygiene intervention']","['insomnia severity and more dysfunctional beliefs', 'Perceived severity of insomnia, sleep-related dysfunctional beliefs, burnout symptoms, restedness, recovery after a shift, and actigraphy-based total sleep time', 'Mood symptoms', 'sleep diary, and actigraphy']","[{'cui': 'C0425104', 'cui_str': 'Shift worker (finding)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",83.0,0.0429972,Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the sleep hygiene control intervention.,"[{'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Järnefelt', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland. heli.jarnefelt@ttl.fi.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Härmä', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sallinen', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Virkkala', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Paajanen', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Kari-Pekka', 'Initials': 'KP', 'LastName': 'Martimo', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Hublin', 'Affiliation': 'Finnish Institute of Occupational Health (FIOH), Topeliuksenkatu 41 b, 00250, Helsinki, Finland.'}]",International archives of occupational and environmental health,['10.1007/s00420-019-01504-6']
3633,31313237,Impact of Exercise on Body Composition and Cardiometabolic Risk Factors in Patients Awaiting Bariatric Surgery.,"BACKGROUND
The role of exercise to achieve weight reductions in patients awaiting bariatric surgery has been little studied. The aim of this study was to describe the effects of an exercise program on body composition and cardiometabolic risk factors in patients awaiting bariatric surgery.
METHODS
Twenty-three patients awaiting bariatric surgery were divided into two groups: (a) an exercise group (EG, n = 12) and (b) a control group (CG, n = 11). Both groups received the usual care prior to surgery, but the EG also performed a 12-week exercise program which combined endurance and resistance training. Body composition, cardiometabolic risk factors, physical fitness, basal metabolic rate, and quality of life were assessed at baseline and at the end of the study.
RESULTS
After the exercise program, the EG achieved significant reductions in total weight (- 7.3 ± 4.1 kg, P < 0.01), fat mass (- 7.1 ± 4.7 kg, P < 0.01), and waist circumference (- 5.3 ± 2.1 cm, P < 0.01), while they maintained their fat-free mass and basal metabolic rate levels. Only the EG showed reductions in HbA1c (- 0.4 ± 0.45%, P < 0.05), systolic (- 10.5 ± 12.7 mmHg), and diastolic blood pressure (- 3.9 ± 5.2 mmHg, P < 0.05), as well as a decrease in waist-to-height ratio (- 0.032 ± 0.12, P < 0.01) and an improvement in quality of life.
CONCLUSIONS
The implementation of an exercise program prior to bariatric surgery reduces fat mass and central obesity and improves cardiometabolic risk factors and quality of life, especially in the physical scales.
TRIAL REGISTRATION
The study was registered at ClinicalTrials.gov (NCT03613766).",2019,"Only the EG showed reductions in HbA1c (- 0.4 ± 0.45%, P < 0.05), systolic (- 10.5 ± 12.7 mmHg), and diastolic blood pressure (- 3.9 ± 5.2 mmHg, P < 0.05), as well as a decrease in waist-to-height ratio (- 0.032 ± 0.12, P < 0.01) and an improvement in quality of life.
","['Twenty-three patients awaiting bariatric surgery', 'Patients Awaiting Bariatric Surgery', 'patients awaiting bariatric surgery']","['exercise program', 'Exercise', 'exercise program prior to bariatric surgery', 'usual care prior to surgery, but the EG also performed a 12-week exercise program which combined endurance and resistance training']","['waist-to-height ratio', 'Body composition, cardiometabolic risk factors, physical fitness, basal metabolic rate, and quality of life', 'fat mass and central obesity and improves cardiometabolic risk factors and quality of life', 'diastolic blood pressure', 'total weight', 'Body Composition and Cardiometabolic Risk Factors', 'quality of life', 'weight reductions', 'fat mass', 'systolic', 'waist circumference', 'body composition and cardiometabolic risk factors']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",23.0,0.0221704,"Only the EG showed reductions in HbA1c (- 0.4 ± 0.45%, P < 0.05), systolic (- 10.5 ± 12.7 mmHg), and diastolic blood pressure (- 3.9 ± 5.2 mmHg, P < 0.05), as well as a decrease in waist-to-height ratio (- 0.032 ± 0.12, P < 0.01) and an improvement in quality of life.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marc-Hernández', 'Affiliation': 'Laboratory of Training Analysis and Optimization, Sport Research Center, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Center of Excellence for the Diagnosis and Treatment of Obesity and Diabetes, Valladolid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aracil', 'Affiliation': 'Department of Sport Sciences, Sport Research Center, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guillén', 'Affiliation': 'Laboratory of Training Analysis and Optimization, Sport Research Center, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Moya-Ramón', 'Affiliation': 'Laboratory of Training Analysis and Optimization, Sport Research Center, Miguel Hernandez University, Elche, Spain. mmoya@umh.es.'}]",Obesity surgery,['10.1007/s11695-019-04088-9']
3634,31342893,Effectiveness of school-home intervention for adolescent obesity prevention: parallel school randomised study.,"Many school-based interventions for obesity prevention have been proposed with positive changes in behaviour, but with unsatisfactory results on weight change. The objective was to verify the effectiveness of a combined school- and home-based obesity prevention programme on excessive weight gain in adolescents. Teachers delivered the school-based primary prevention programme to fifth- and sixth-graders (nine schools, forty-eight control classes, forty-nine intervention classes), which included encouraging healthy eating habits and physical activity. A subgroup of overweight or obese adolescents also received a home-based secondary prevention programme delivered by community health professionals. Schools were randomised to intervention or control group. Intent-to-treat analysis used mixed models for repeated continuous measures and considered the cluster effect. The main outcomes were changes in BMI and percentage body fat (%body fat) after one school-year of intervention and follow-up. Against our hypothesis, BMI increased more in the intervention group than in the control group (Δ = 0·3 kg/m2; P = 0·05) with a greater decrease in %body fat among boys (Δ = -0·6 %; P = 0·03) in the control group. The intervention group increased physical activity by 12·5 min per week compared with the control group. Female adolescents in the intervention group ate healthier items more frequently than in the control group. The subgroup that received both the school and home interventions had an increase in %body fat than in the control group (Δ = 0·89 %; P = 0·01). In the present study, a behavioural change led to a small increase in physical activity and healthy eating habits but also to an overall increase in food intake.",2019,The subgroup who received both the school and home interventions had an increase in %body fat than in the control group (Δ=0.89%; p=0.01).,"['adolescents', 'A subgroup of overweight or obese adolescents', 'adolescent obesity prevention', 'Female adolescents']","['home-based secondary prevention program delivered by community health professionals', 'school-home intervention', 'combined school and home-based obesity prevention program']","['BMI', 'excessive weight gain', 'body mass index (BMI) and percent body fat (%body fat', 'physical activity and healthy eating habits', 'physical activity', 'body fat']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4317171', 'cui_str': 'Adolescent Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0000765', 'cui_str': 'Excessive weight gain (finding)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.0254223,The subgroup who received both the school and home interventions had an increase in %body fat than in the control group (Δ=0.89%; p=0.01).,"[{'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Sgambato', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}, {'ForeName': 'Diana B', 'Initials': 'DB', 'LastName': 'Cunha', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}, {'ForeName': 'Bárbara S N', 'Initials': 'BSN', 'LastName': 'Souza', 'Affiliation': 'Department of Epidemiology, Fluminense Federal University, Rio de Janeiro 24030-210, Brazil.'}, {'ForeName': 'Viviana T', 'Initials': 'VT', 'LastName': 'Henriques', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}, {'ForeName': 'Renata R M', 'Initials': 'RRM', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}, {'ForeName': 'Ana L V', 'Initials': 'ALV', 'LastName': 'Rêgo', 'Affiliation': 'Department of Social and Applied Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro 21941-590, Brazil.'}, {'ForeName': 'Rosangela A', 'Initials': 'RA', 'LastName': 'Pereira', 'Affiliation': 'Department of Social and Applied Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro 21941-590, Brazil.'}, {'ForeName': 'Edna M', 'Initials': 'EM', 'LastName': 'Yokoo', 'Affiliation': 'Department of Epidemiology, Fluminense Federal University, Rio de Janeiro 24030-210, Brazil.'}, {'ForeName': 'Rosely', 'Initials': 'R', 'LastName': 'Sichieri', 'Affiliation': 'Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro 20550-900, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114519001818']
3635,31400513,Targeting pregnancy-related weight gain to reduce disparities in obesity: Baseline results from the Healthy Babies trial.,"BACKGROUND
Obesity affects African American women more than any other group in the US. Pregnancy represents a critical life stage of heightened vulnerability for new or persistent obesity, yet few interventions have been effective in reducing excessive gestational weight gain among African American women. We describe the design and baseline findings of Healthy Babies, a two-arm randomized controlled trial testing a mobile health intervention to minimize excessive gestational weight gain versus usual care in this high risk group.
METHODS
African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics. Participants randomized to the intervention received behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group. Data collection included baseline (<22 weeks' gestation), 36-38 weeks' gestation, and 6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets. The primary outcome was prevalence of excessive gestational weight gain.
RESULTS
Among participants at baseline (n = 262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6 ± 5.4 years old with a gestational age of 13.9 ± 4.1 weeks. While 82% completed high school, 61% met criteria for inadequate health literacy. Nearly 20% were food insecure. Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines. There were no significant differences in baseline characteristics between study arms.
CONCLUSIONS
Participants represent a high-risk group for excessive gestational weight gain with demonstrated need for intervention.",2019,"There were no significant differences in baseline characteristics between study arms.
","['African American women', 'Healthy Babies trial', ""African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics"", 'Healthy Babies', 'Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines', 'participants at baseline (n\u202f=\u202f262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6\u202f±\u202f5.4\u202fyears old with a gestational age of 13.9\u202f±\u202f4.1\u202fweeks']","['mobile health intervention to minimize excessive gestational weight gain versus usual care', 'behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group']","['6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets', 'excessive gestational weight gain', 'prevalence of excessive gestational weight gain']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0021621', 'cui_str': 'National Academies of Science, Engineering, and Medicine (US) Health and Medicine Division'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026751', 'cui_str': 'Multiparity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.278138,"There were no significant differences in baseline characteristics between study arms.
","[{'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America. Electronic address: herris01@temple.edu.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Albert', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Niesha', 'Initials': 'N', 'LastName': 'Darden', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Bailer', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Cruice', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Sarmina', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, United States of America; Duke Digital Health Science Center, Duke Global Health Institute, Durham, NC, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goetzl', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Center at Houston, Houston, TX, United States of America.'}, {'ForeName': 'Daohai', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Kilby', 'Affiliation': 'Philadelphia Women, Infants and Children Program, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Weight Watchers International, New York, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105822']
3636,32132410,Sedation with remifentanil or propofol for flexible bronchoscopy: A randomised controlled trial.,,2020,,['flexible bronchoscopy'],['remifentanil or propofol'],[],"[{'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",[],,0.128659,,"[{'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Maurel', 'Affiliation': 'From the Department of Anaesthesiology, Critical Care and Burn Unit, Saint-Louis Hospital, Assistance-Publique Hôpitaux de Paris & Paris Diderot University (VM, MLegr, EB, ALM, FB, AN, MLego, BP), INSERM UMR-S 942, Institut National de la Santé et de la Recherche Medicale (INSERM), Lariboisière Hospital (MLegr), INI-CRCT NETWORK (MLegr), Respiratory Medicine Department, Paris Diderot University, Assistance Publique-Hôpitaux de Paris, Saint-Louis Hospitals (AB) and Clinical Research Unit, Assistance Publique Hôpitaux de Paris, Fernand-Widal Hospital, Paris, France (EV).'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Legrand', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bourgeois', 'Affiliation': ''}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Masse', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bergeron', 'Affiliation': ''}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Binakdane', 'Affiliation': ''}, {'ForeName': 'Aristide', 'Initials': 'A', 'LastName': 'Ntahe', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Legouge', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': ''}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Plaud', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001068']
3637,29182037,DRD4 exon 3 genotype and ADHD: Randomised pharmacodynamic investigation of treatment response to methylphenidate.,"Objectives: Dopamine plays an important role in modulating attention and motor behaviours, dimensions altered in attention deficit/hyperactivity disorder (ADHD). Numerous association studies have linked dopamine receptor 4 ( DRD4 ) to increased risk of ADHD. This study investigated the effect of DRD4 exon 3 polymorphism on child behaviours in response to treatment with methylphenidate. Methods: A total of 374 children diagnosed with ADHD (ages 6-12 years) were evaluated under three experimental conditions: baseline, placebo and MPH (0.5 mg/kg/day). This was a 2-week prospective within-subject, placebo-controlled, crossover trial. The Conners' Global Index for parents and for teachers was used to evaluate the behaviours of the children. One-way repeated measures analysis of variance was used to test the effect of the interaction between DRD4 genotype and experimental conditions. Results: A significant interaction between DRD4 genotype and treatment was detected when the child's behaviour was evaluated by the parents ( P = 0.035, effect size of 0.014), driven by a better treatment response in children homozygous for long 7-repeat allele. Conclusions: According to the parent assessment, children homozygous for the long 7-repeat allele were more responsive to experimental condition. This is the largest pharmacogenetic investigation of the effect of DRD4 exon 3 polymorphism in childhood ADHD. Trial Registration: clinicaltrials.gov, identifier NCT00483106.",2019,"A significant interaction between DRD4 genotype and treatment was detected when the child's behaviour was evaluated by the parents (P = 0.035, effect size of 0.014), driven by a better treatment response in children homozygous for long 7-repeat allele.
",['374 children diagnosed with ADHD (ages 6-12 years'],"['placebo and MPH', 'methylphenidate', 'placebo']","[""child's behaviour"", 'child behaviours', 'DRD4 exon 3 genotype and ADHD']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]",374.0,0.19056,"A significant interaction between DRD4 genotype and treatment was detected when the child's behaviour was evaluated by the parents (P = 0.035, effect size of 0.014), driven by a better treatment response in children homozygous for long 7-repeat allele.
","[{'ForeName': 'Darya', 'Initials': 'D', 'LastName': 'Naumova', 'Affiliation': 'Department of Human Genetics, McGill University , Montreal , QC , Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grizenko', 'Affiliation': 'Douglas Mental Health University Institute , Verdun , QC , Canada.'}, {'ForeName': 'Sarojini M', 'Initials': 'SM', 'LastName': 'Sengupta', 'Affiliation': 'Douglas Mental Health University Institute , Verdun , QC , Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Department of Human Genetics, McGill University , Montreal , QC , Canada.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2017.1410221']
3638,31644357,"Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer.","PURPOSE
We previously reported the safety and immunologic effects of a DNA vaccine (pTVG-HP [MVI-816]) encoding prostatic acid phosphatase (PAP) in patients with recurrent, nonmetastatic prostate cancer. The current trial evaluated the effects of this vaccine on metastatic progression.
PATIENTS AND METHODS
Ninety-nine patients with castration-sensitive prostate cancer and prostate-specific antigen (PSA) doubling time (DT) of less than 12 months were randomly assigned to treatment with either pTVG-HP co-administered intradermally with 200 μg granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant or 200 μg GM-CSF alone six times at 14-day intervals and then quarterly for 2 years. The primary end point was 2-year metastasis-free survival (MFS). Secondary and exploratory end points were median MFS, changes in PSA DT, immunologic effects, and changes in quantitative 18 F-sodium fluoride (NaF) positron emission tomography/computed tomography (PET/CT) imaging.
RESULTS
Two-year MFS was not different between study arms (41.8% vaccine v 42.3%; P = .97). Changes in PSA DT and median MFS were not different between study arms (18.9 v 18.3 months; hazard ratio [HR], 1.6; P = .13). Preplanned subset analysis identified longer MFS in vaccine-treated patients with rapid (< 3 months) pretreatment PSA DT (12.0 v 6.1 months; n = 21; HR, 4.4; P = .03). PAP-specific T cells were detected in both cohorts, including multifunctional PAP-specific T-helper 1-biased T cells. Changes in total activity (total standardized uptake value) on 18 F-NaF PET/CT from months 3 to 6 increased 50% in patients treated with GM-CSF alone and decreased 23% in patients treated with pTVG-HP (n = 31; P = .07).
CONCLUSION
pTVG-HP treatment did not demonstrate an overall increase in 2-year MFS in patients with castration-sensitive prostate cancer, with the possible exception of a subgroup with rapidly progressive disease. Prespecified 18 F-NaF PET/CT imaging conducted in a subset of patients suggests that vaccination had detectable effects on micrometastatic bone disease. Additional trials using pTVG-HP in combination with PD-1 blockade are under way.",2019,"Changes in PSA DT and median MFS were not different between study arms (18.9 v 18.3 months; hazard ratio [HR], 1.6; P = .13).","['patients with recurrent, nonmetastatic prostate cancer', 'patients with castration-sensitive prostate cancer', 'Ninety-nine patients with castration-sensitive prostate cancer and prostate-specific antigen (PSA) doubling time (DT) of less than 12 months', 'Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer']","['GM-CSF', 'pTVG-HP co-administered intradermally with 200 μg granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant or 200 μg GM-CSF', 'DNA vaccine (pTVG-HP [MVI-816]) encoding prostatic acid phosphatase (PAP', 'DNA', 'Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816', 'vaccine', 'pTVG-HP treatment', 'pTVG-HP']","['PSA DT and median MFS', 'total activity (total standardized uptake value', 'micrometastatic bone disease', 'PAP-specific T cells', 'median MFS, changes in PSA DT, immunologic effects, and changes in quantitative 18 F-sodium fluoride (NaF) positron emission tomography/computed tomography (PET/CT) imaging', '2-year metastasis-free survival (MFS', '2-year MFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}, {'cui': 'C0523444', 'cui_str': 'Prostatic acid phosphatase measurement (procedure)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005940', 'cui_str': 'Bone Diseases'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C3652487', 'cui_str': 'sodium fluoride (18F)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",99.0,0.082602,"Changes in PSA DT and median MFS were not different between study arms (18.9 v 18.3 months; hazard ratio [HR], 1.6; P = .13).","[{'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'McNeel', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Eickhoff', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Johnson', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Roth', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Perk', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wargowski', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeraj', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University of Wisconsin, Madison, WI.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01701']
3639,31482354,Characterizing the learning curve of a virtual intracorporeal suturing simulator VBLaST-SS©.,"BACKGROUND
The virtual basic laparoscopic skill trainer suturing simulator (VBLaST-SS©) was developed to simulate the intracorporeal suturing task in the FLS program. The purpose of this study was to evaluate the training effectiveness and participants' learning curves on the VBLaST-SS© and to assess whether the skills were retained after 2 weeks without training.
METHODS
Fourteen medical students participated in the study. Participants were randomly assigned to two training groups (7 per group): VBLaST-SS© or FLS, based on the modality of training. Participants practiced on their assigned system for one session (30 min or up to ten repetitions) a day, 5 days a week for three consecutive weeks. Their baseline, post-test, and retention (after 2 weeks) performance were also analyzed. Participants' performance scores were calculated based on the original FLS scoring system. The cumulative summation (CUSUM) method was used to evaluate learning. Two-way mixed factorial ANOVA was used to compare the effects of group, time point (baseline, post-test, and retention), and their interaction on performance.
RESULTS
Six out of seven participants in each group reached the predefined proficiency level after 7 days of training. Participants' performance improved significantly (p < 0.001) after training within their assigned group. The CUSUM learning curve shows that one participant in each group achieved 5% failure rate by the end of the training period. Twelve out of fourteen participants' CUSUM curves showed a negative trend toward achieving the 5% failure rate after further training.
CONCLUSION
The VBLaST-SS© is effective in training laparoscopic suturing skill. Participants' performance of intracorporeal suturing was significantly improved after training on both systems and was retained after 2 weeks of no training.",2020,Participants' performance of intracorporeal suturing was significantly improved after training on both systems and was retained after 2 weeks of no training.,['Fourteen medical students participated in the study'],"['VBLaST-SS© or FLS', 'laparoscopic skill trainer suturing simulator (VBLaST-SS©', 'VBLaST-SS']","['cumulative summation (CUSUM', 'performance of intracorporeal suturing', 'failure rate']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0234108', 'cui_str': 'Summation, function (observable entity)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",14.0,0.0281358,Participants' performance of intracorporeal suturing was significantly improved after training on both systems and was retained after 2 weeks of no training.,"[{'ForeName': 'Yaoyu', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Department of Industrial and System Engineering, University at Buffalo, Buffalo, NY, 14260, USA.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Cavuoto', 'Affiliation': 'Department of Industrial and System Engineering, University at Buffalo, Buffalo, NY, 14260, USA. loracavu@buffalo.edu.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Qi', 'Affiliation': 'Center for Modeling, Simulation and Imaging in Medicine (CeMSIM), Rensselaer Polytechnic Institute, Troy, NY, USA.'}, {'ForeName': 'Karthikeyan', 'Initials': 'K', 'LastName': 'Panneerselvam', 'Affiliation': 'Center for Modeling, Simulation and Imaging in Medicine (CeMSIM), Rensselaer Polytechnic Institute, Troy, NY, USA.'}, {'ForeName': 'Venkata Sreekanth', 'Initials': 'VS', 'LastName': 'Arikatla', 'Affiliation': 'Medical Computing Group, Kitware, Inc., Carrboro, NC, USA.'}, {'ForeName': 'Andinet', 'Initials': 'A', 'LastName': 'Enquobahrie', 'Affiliation': 'Medical Computing Group, Kitware, Inc., Carrboro, NC, USA.'}, {'ForeName': 'Suvranu', 'Initials': 'S', 'LastName': 'De', 'Affiliation': 'Center for Modeling, Simulation and Imaging in Medicine (CeMSIM), Rensselaer Polytechnic Institute, Troy, NY, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Schwaitzberg', 'Affiliation': 'UB RIS²E², Department of Surgery, University at Buffalo, Buffalo, NY, USA.'}]",Surgical endoscopy,['10.1007/s00464-019-07081-6']
3640,31399245,"Links between Shared Reading and Play, Parent Psychosocial Functioning, and Child Behavior: Evidence from a Randomized Controlled Trial.","OBJECTIVE
To investigate pathways by which interventions that promote shared reading and play help prevent child behavior problems. We examined whether family processes associated with the family investment pathway (eg, parental cognitive stimulation) and the family stress pathway (eg, mothers' psychosocial functioning) mediated impacts of a pediatric-based preventive intervention on child behavior.
STUDY DESIGN
The sample included 362 low-income mothers and their children who participated in a randomized controlled trial of the Video Interaction Project, a pediatrics-based preventive intervention that promotes parent-child interactions in the context of shared reading and play. Parent-child dyads were randomly assigned to group at birth. Three mediators-parental cognitive stimulation, maternal stress about the parent-child relationship, and maternal depressive symptoms-were assessed at child ages 6 and 36 months. The outcome, child externalizing behaviors, was assessed at 36 months. We used a series of path analytic models to examine how these family processes, separately or together, mediated the impacts of the Video Interaction Project on child behavioral outcomes.
RESULTS
Intervention impacts on child behavior were mediated by enhancements in cognitive stimulation and by improvements in mothers' psychosocial functioning. A sequential mediation model showed that Video Interaction Project impacts on cognitive stimulation at 6 months were associated with later decreases in mothers' stress about the parent-child relationship and that this pathway mediated intervention impacts on child behavioral outcomes at 3 years of age (P = .023).
CONCLUSIONS
Using an experimental design, this study identifies pathways by which parent-child interactions in shared reading and play can improve child behavioral outcomes.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT00212576.",2019,"A sequential mediation model showed that Video Interaction Project impacts on cognitive stimulation at 6 months were associated with later decreases in mothers' stress about the parent-child relationship and that this pathway mediated intervention impacts on child behavioral outcomes at 3 years of age (P = .023).
","['Parent-child dyads', '362 low-income mothers and their children who participated']","['Video Interaction Project, a pediatrics-based preventive intervention that promotes parent-child interactions in the context of shared reading and play']","['child externalizing behaviors', ""mothers' psychosocial functioning"", 'child behavioral outcomes', 'cognitive stimulation', 'child behavior', 'mediators-parental cognitive stimulation, maternal stress about the parent-child relationship, and maternal depressive symptoms']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",362.0,0.0477504,"A sequential mediation model showed that Video Interaction Project impacts on cognitive stimulation at 6 months were associated with later decreases in mothers' stress about the parent-child relationship and that this pathway mediated intervention impacts on child behavioral outcomes at 3 years of age (P = .023).
","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weisleder', 'Affiliation': 'New York University School of Medicine, Department of Pediatrics, New York, NY; Northwestern University, Department of Communications Sciences and Disorders, Evanston, IL. Electronic address: adriana.weisleder@northwestern.edu.'}, {'ForeName': 'Carolyn Brockmeyer', 'Initials': 'CB', 'LastName': 'Cates', 'Affiliation': 'New York University School of Medicine, Department of Pediatrics, New York, NY; SUNY Purchase College, Department of Psychology, Purchase, NY.'}, {'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Harding', 'Affiliation': 'Mathematica, Princeton, NJ.'}, {'ForeName': 'Samantha B', 'Initials': 'SB', 'LastName': 'Johnson', 'Affiliation': 'New York University School of Medicine, Department of Pediatrics, New York, NY; Marymount Manhattan College, Department of Psychology, New York, NY.'}, {'ForeName': 'Caitlin F', 'Initials': 'CF', 'LastName': 'Canfield', 'Affiliation': 'New York University School of Medicine, Department of Pediatrics, New York, NY.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Seery', 'Affiliation': 'New York University School of Medicine, Department of Pediatrics, New York, NY.'}, {'ForeName': 'Caroline D', 'Initials': 'CD', 'LastName': 'Raak', 'Affiliation': 'New York University School of Medicine, Department of Pediatrics, New York, NY.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'New York University School of Medicine, Department of Pediatrics, New York, NY.'}, {'ForeName': 'Benard P', 'Initials': 'BP', 'LastName': 'Dreyer', 'Affiliation': 'New York University School of Medicine, Department of Pediatrics, New York, NY.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'New York University School of Medicine, Department of Pediatrics, New York, NY.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.06.037']
3641,31397290,Blood pressure control and clinical outcomes in acute intracerebral haemorrhage: a preplanned pooled analysis of individual participant data.,"BACKGROUND
Uncertainty persists over the effects of blood pressure lowering in acute intracerebral haemorrhage. We aimed to combine individual patient-level data from the two largest randomised controlled trials of blood pressure lowering strategies in patients with acute intracerebral haemorrhage to determine the strength of associations between key measures of systolic blood pressure control and safety and efficacy outcomes.
METHODS
We did a preplanned pooled analysis of individual patient-level data acquired from the main phase of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2) and the second Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) trial. These trials included adult patients aged 19-99 years with spontaneous (non-traumatic) intracerebral haemorrhage and elevated systolic blood pressure, without a clear indication or contraindication to treatment. Patients were excluded if they had a structural cerebral cause for the intracerebral haemorrhage, had a low score (3-5) on the Glasgow Coma Scale, or required immediate neurosurgery. Our primary analysis assessed the independent associations between three post-randomisation systolic blood pressure summary measures-magnitude of reduction in 1 h, mean achieved systolic blood pressure, and variability in systolic blood pressure between 1 h and 24 h-and the primary outcome of functional status, as defined by the distribution of scores on the modified Rankin Scale at 90 days post-randomisation. We analysed the systolic blood pressure measures as continuous variables using generalised linear mixed models, adjusted for baseline covariables and trial. The primary and safety analyses were done in a modified intention-to-treat population, which only included patients with sufficient data on systolic blood pressure.
FINDINGS
3829 patients (mean age 63·1 years [SD 12·9], 1429 [37%] women, and 2490 [65%] Asian ethnicity) were randomly assigned in INTERACT2 and ATACH-II, with a median neurological impairment defined by scores on the National Institutes of Health Stroke Scale of 11 (IQR 6-16) and median time from the onset of symptoms of intracerebral haemorrhage to randomisation of 3·6 h (2·7-4·4). We excluded 20 patients with insufficient or no systolic blood pressure data, and we imputed missing systolic blood pressure data in 23 (1%) of the remaining 3809 patients. Overall, the mean magnitude of early systolic blood pressure reduction was 29 mm Hg (SD 22), and subsequent mean systolic blood pressure achieved was 147 mm Hg (15) and variability in systolic blood pressure was 14 mm Hg (8). Achieved systolic blood pressure was continuously associated with functional status (improvement per 10 mm Hg increase adjusted odds ratio [OR] 0·90 [95% CI 0·87-0·94], p<0·0001). Symptomatic hypotension occurred in 28 (1%) patients, renal serious adverse events occurred in 26 (1%) patients, and cardiac serious adverse events occurred in 99 (3%) patients.
INTERPRETATION
Our pooled analyses indicate that achieving early and stable systolic blood pressure seems to be safe and associated with favourable outcomes in patients with acute intracerebral haemorrhage of predominantly mild-to-moderate severity.
FUNDING
None.",2019,"Achieved systolic blood pressure was continuously associated with functional status (improvement per 10 mm Hg increase adjusted odds ratio [OR] 0·90 [95% CI 0·87-0·94], p<0·0001).","['20 patients with insufficient or no systolic blood pressure data, and we imputed missing systolic blood pressure data in 23 (1%) of the remaining 3809 patients', 'patients with acute intracerebral haemorrhage', '3829 patients (mean age 63·1 years [SD 12·9], 1429 [37%] women, and 2490', 'patients with acute intracerebral haemorrhage of predominantly mild-to-moderate severity', 'We did a preplanned pooled analysis of individual patient-level data acquired from the main phase of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2) and the second Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) trial', 'adult patients aged 19-99 years with spontaneous (non-traumatic) intracerebral haemorrhage and elevated systolic blood pressure, without a clear indication or contraindication to treatment', 'acute intracerebral haemorrhage', 'Patients were excluded if they had a structural cerebral cause for the intracerebral haemorrhage, had a low score (3-5) on the Glasgow Coma Scale, or required immediate neurosurgery', '65%] Asian ethnicity']",['blood pressure lowering strategies'],"['systolic blood pressure measures', 'mean magnitude of early systolic blood pressure reduction', 'Symptomatic hypotension', 'systolic blood pressure', 'systolic blood pressure control and safety and efficacy outcomes', 'mean systolic blood pressure', 'renal serious adverse events', 'cardiac serious adverse events', 'systolic blood pressure, and variability in systolic blood pressure', 'Blood pressure control and clinical outcomes', 'modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",3829.0,0.233463,"Achieved systolic blood pressure was continuously associated with functional status (improvement per 10 mm Hg increase adjusted odds ratio [OR] 0·90 [95% CI 0·87-0·94], p<0·0001).","[{'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Moullaali', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Virginia B', 'Initials': 'VB', 'LastName': 'Shipes', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; National Institute for Health Research Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO, USA; Zeenat Qureshi Stroke Institute, St. Cloud, MO, USA.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia; George Institute China at Peking University Health Science Center, Beijing, China. Electronic address: canderson@georgeinstitute.org.au.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30196-6']
3642,31392958,Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.,"BACKGROUND
Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI.
OBJECTIVE
To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds.
DESIGN
Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved.
SETTING
Usual NHS care.
PARTICIPANTS
Patients undergoing elective/non-elective abdominal surgery, including caesarean section.
INTERVENTIONS
Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'.
MAIN OUTCOME MEASURES
Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers.
DATA SOURCES
Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals.
RESULTS
Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy ( c -statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.
LIMITATIONS
Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres.
CONCLUSIONS
A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks.
TRIAL REGISTRATION
Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).",2019,"The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.
","['primary surgical wounds', 'Phase A - we interviewed 102 participants', 'Patients undergoing elective/non-elective abdominal surgery, including caesarean section', 'surgical site infection after abdominal surgery', 'no dressing, n \u2009=\u2009132', 'We interviewed 55 participants', '862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n \u2009=\u2009133; glue, n \u2009=\u2009129', 'Phase B - from 4 March 2016 to 30 November 2016']","[""Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing"", 'dressing types or no dressing to reduce SSI']","['SSI questionnaire response rate overall', 'SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT', 'SSI questionnaire', 'diagnostic accuracy', 'SSI']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332803', 'cui_str': 'Surgical Incision'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0017780', 'cui_str': 'Glues'}]","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0017780', 'cui_str': 'Glues'}, {'cui': 'C0040277', 'cui_str': 'Tissue Adhesives'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0567460', 'cui_str': 'Dressing practice (regime/therapy)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",102.0,0.100827,"The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.
","[{'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Rooshenas', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rhiannon C', 'Initials': 'RC', 'LastName': 'Macefield', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Nicky J', 'Initials': 'NJ', 'LastName': 'Welton', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Waterhouse', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Torrance', 'Affiliation': 'Department of Surgery, Sandwell and West Birmingham NHS Trust, West Bromwich, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Strong', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Siassakos', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Seligman', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Rickard', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pullyblank', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pope', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Pinkney', 'Affiliation': 'Academic Department of Surgery, Queen Elizabeth Hospital, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Owais', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': ""O'Callaghan"", 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Nepogodiev', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Khaldoun', 'Initials': 'K', 'LastName': 'Nadi', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Murkin', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tonia', 'Initials': 'T', 'LastName': 'Munder', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Milne', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Messenger', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Christel M', 'Initials': 'CM', 'LastName': 'McMullan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Mathers', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Morwena', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lovegrove', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Longman', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lloyd', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Korwar', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hill', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hamdan', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Hannah Gould', 'Initials': 'HG', 'LastName': 'Brown', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'Musculoskeletal Research Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Glasbey', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fryer', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Elliott', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jo C', 'Initials': 'JC', 'LastName': 'Dumville', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Draycott', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cotton', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Coast', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Calvert', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Byrne', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Oliver D', 'Initials': 'OD', 'LastName': 'Brown', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Blencowe', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katarzyna D', 'Initials': 'KD', 'LastName': 'Bera', 'Affiliation': 'Clinical Academic Graduate School, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bamford', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Danya', 'Initials': 'D', 'LastName': 'Bakhbakhi', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Atif', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Armstrong', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Lazaros', 'Initials': 'L', 'LastName': 'Andronis', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Piriyankan', 'Initials': 'P', 'LastName': 'Ananthavarathan', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23390']
3643,32112166,A Comparison of Intrathecal and Intravenous Morphine for Analgesia After Hepatectomy: A Randomized Controlled Trial.,"BACKGROUND
Effective analgesia is essential for patient recovery after liver resection. This study aimed to evaluate the effects of the addition of preoperative intrathecal morphine to multimodal intravenous analgesia in patients undergoing liver resection.
METHODS
In this single-blind randomized controlled trial, patients undergoing liver resection were randomly assigned to the patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine groups. All patients received acetaminophen and dexketoprofen. The primary outcome was pain severity at rest over three postoperative days, assessed using the numerical rating scale (NRS).
RESULTS
The study included 36 patients (18 in each group). The mean maximum daily NRS scores over the first three postoperative days in the ITM-IV and IV groups were 1.3, 1.1, and 0.3 and 1.6, 1.1, and 0.7, respectively (p = 0.580). No differences were observed in pain severity while coughing, with corresponding scores of 2.8, 2.1, and 1.1, respectively, in the ITM-IV group and 2.3, 2.2, and 1.5, respectively, in the IV group (p = 0.963). Proportions of patients reporting clinically significant pain at rest and while coughing were 11.1% and 44.4%, respectively, in the ITM-IV group, and 16.7% and 44.4%, respectively, in the IV group (both p > 0.999). Cumulative morphine doses in the ITM-IV and IV groups were 26 mg and 17 mg, respectively (p = 0.257). Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
CONCLUSIONS
Preoperative intrathecal morphine administration provides no benefits to multimodal analgesia in patients undergoing liver resection.
TRIAL REGISTRATION NUMBER
Clinicaltrial.gov Identifier: NCT03620916.",2020,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
","['patients undergoing liver resection', 'patient recovery after liver resection', '36 patients (18 in each group']","['patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine', 'acetaminophen and dexketoprofen', 'morphine', 'Intrathecal and Intravenous Morphine', 'preoperative intrathecal morphine']","['pain severity while coughing', 'sedation grade', 'pain severity', 'time to mobilization', 'solid food intake', 'mean maximum daily NRS scores', 'morbidity', 'pain at rest and while coughing', 'Analgesia', 'numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0453855', 'cui_str': 'Solid food (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0222045'}]",36.0,0.200098,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
","[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Niewiński', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Figiel', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland. w.figiel@yahoo.es.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Grąt', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Dec', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Morawski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Patkowski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zieniewicz', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}]",World journal of surgery,['10.1007/s00268-020-05437-x']
3644,32072388,Development and validation of prognostic nomograms in patients with adrenocortical carcinoma: a population-based study.,"BACKGROUND
Predicting the prognosis of patients with adrenocortical carcinoma (ACC) is difficult, due to its unpredictable behavior. The aim of this study is to develop and validate a nomogram to predict survival outcomes in patients with ACC.
METHODS
Nomograms were established using the data collected from the Surveillance, Epidemiology, and End Results (SEER) database. Based on univariate and multivariate Cox regression analyses, we identified independent risk factors for overall survival (OS) and cancer-specific survival (CSS). Concordance indexes (c-indexes), the area under the receiver operating characteristics curve (AUC) and calibration curve were used to evaluate predictive performance of these models. The clinical use of nomogram was measured by decision curve analysis (DCA) and clinical impact curves.
RESULTS
A total of 855 eligible patients, randomly divided into training (n = 600) and validation cohorts (n = 255), were included in this study. Based on the independent predictors, the nomograms were established and demonstrated good discriminative abilities, with C-indexes for OS and CSS were 0.762 and 0.765 in training cohorts and 0.738 and 0.758 in validation cohorts, respectively. The AUC and calibration plots also demonstrated a good performance for both nomograms. DCA indicated that the two nomograms provide clinical net benefits.
CONCLUSION
We unveiled the prognostic factors of ACC and developed novel nomograms that predict OS and CSS more accurately and comprehensively, which can help clinicians improve individual treatment, making proper clinical decisions and adjusting follow-up management strategies.",2020,"Based on the independent predictors, the nomograms were established and demonstrated good discriminative abilities, with C-indexes for OS and CSS were 0.762 and 0.765 in training cohorts and 0.738 and 0.758 in validation cohorts, respectively.","['855 eligible patients, randomly divided into training (n\u2009=\u2009600) and validation cohorts (n\u2009=\u2009255', 'patients with ACC', 'patients with adrenocortical carcinoma', 'patients with adrenocortical carcinoma (ACC']",['DCA'],"['overall survival (OS) and cancer-specific survival (CSS', 'good discriminative abilities, with C-indexes for OS and CSS', 'survival outcomes', 'Concordance indexes (c-indexes), the area under the receiver operating characteristics curve (AUC) and calibration curve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0206686', 'cui_str': 'Carcinoma, Adrenal Cortical'}]","[{'cui': 'C0600203', 'cui_str': 'DCA'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}]",855.0,0.029169,"Based on the independent predictors, the nomograms were established and demonstrated good discriminative abilities, with C-indexes for OS and CSS were 0.762 and 0.765 in training cohorts and 0.738 and 0.758 in validation cohorts, respectively.","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital, Sun Yat-Sen University, No. 52, Meihua East Road, Zhuhai, 519000, Guangdong, China.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Naji', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital, Sun Yat-Sen University, No. 52, Meihua East Road, Zhuhai, 519000, Guangdong, China.'}, {'ForeName': 'Minbo', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital, Sun Yat-Sen University, No. 52, Meihua East Road, Zhuhai, 519000, Guangdong, China.'}, {'ForeName': 'Wenfei', 'Initials': 'W', 'LastName': 'Lian', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital, Sun Yat-Sen University, No. 52, Meihua East Road, Zhuhai, 519000, Guangdong, China.'}, {'ForeName': 'Maochun', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital, Sun Yat-Sen University, No. 52, Meihua East Road, Zhuhai, 519000, Guangdong, China.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Urology, The Fifth Affiliated Hospital, Sun Yat-Sen University, No. 52, Meihua East Road, Zhuhai, 519000, Guangdong, China. daiyb@mail.sysu.edu.cn.'}]",International urology and nephrology,['10.1007/s11255-020-02413-1']
3645,32133585,Baseline-dependent effect of dopamine's precursor L-tyrosine on working memory gating but not updating.,"Adaptive goal-directed behavior requires a dynamic balance between maintenance and updating within working memory (WM). This balance is controlled by an input-gating mechanism implemented by dopamine in the basal ganglia. Given that dopaminergic manipulations can modulate performance on WM-related tasks, it is important to gain mechanistic insight into whether such manipulations differentially affect updating (i.e., encoding and removal) and the closely-related gate opening/closing processes that respectively enable/prevent updating. To clarify this issue, 2.0 g of dopamine's precursor L-tyrosine was administered to healthy young adults (N = 45) in a double-blind, placebo-controlled, within-subjects study. WM processes were empirically distinguished using the reference-back paradigm, which isolates performance related to updating, gate opening, and gate closing. L-tyrosine had a selective, baseline-dependent effect only on gate opening, which was evidenced by markedly reduced variance across subjects in gate opening performance in the L-tyrosine compared with the placebo condition, whereas the whole-sample average performance did not differ between conditions. This indicates a pattern of results whereby low-performing subjects improved, whereas high-performing subjects were impaired on L-tyrosine. Importantly, this inverted U-shaped pattern was not explained by regression to the mean. These results are consistent with an inverted-U relationship between dopamine and WM, and they indicate that updating and gating are differentially affected by a dopaminergic manipulation. This highlights the importance of distinguishing these processes when studying WM, for example, in the context of WM deficits in disorders with a dopaminergic pathophysiology.",2020,"L-tyrosine had a selective, baseline-dependent effect only on gate opening, which was evidenced by markedly reduced variance across subjects in gate opening performance in the L-tyrosine compared with the placebo condition, whereas the whole-sample average performance did not differ between conditions.",['healthy young adults (N = 45'],"['placebo', 'dopaminergic manipulations', ""dopamine's precursor L-tyrosine""]",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}]",[],45.0,0.0628613,"L-tyrosine had a selective, baseline-dependent effect only on gate opening, which was evidenced by markedly reduced variance across subjects in gate opening performance in the L-tyrosine compared with the placebo condition, whereas the whole-sample average performance did not differ between conditions.","[{'ForeName': 'Bryant J', 'Initials': 'BJ', 'LastName': 'Jongkees', 'Affiliation': 'Institute of Psychology & Leiden Institute for Brain and Cognition, Leiden University, Wassenaarseweg 52, 2333AK, Leiden, the Netherlands. b.j.jongkees@fsw.leidenuniv.nl.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00783-8']
3646,30375104,Cardioversion of atrial fibrillation in obese patients: Results from the Cardioversion-BMI randomized controlled trial.,"AIMS
Obesity is associated with higher electrical cardioversion (ECV) failure in persistent atrial fibrillation (PeAF). For ease-of-use, many centers prefer patches over paddles. We assessed the optimum modality and shock vector, as well as the safety and efficacy of the Manual Pressure Augmentation (MPA) technique.
METHODS
Patients with obesity (BMI ≥ 30) and PeAF undergoing ECV using a biphasic defibrillator were randomized into one of four arms by modality (adhesive patches or handheld paddles) and shock vector (anteroposterior [AP] or anteroapical [AA]). If the first two shocks (100 and 200 J) failed, then patients received a 200-J shock using the alternative modality (patch or paddle). Shock vector remained unchanged. In an observational substudy, 20 patients with BMI of 35 or more, and who failed ECV at 200 J using both patches/paddles underwent a trial of MPA.
RESULTS
In total, 125 patients were randomized between July 2016 and March 2018. First or second shock success was 43 of 63 (68.2%) for patches and 56 of 62 (90.3%) for paddles (P = 0.002). There were 20 crossovers from patches to paddles (12 of 20 third shock success with paddles) and six crossovers from paddles to patches (three of six third shock success with patches). Paddles successfully cardioverted 68 of 82 patients compared with 46 of 69 using patches (82.9% vs 66.7%; P = 0.02). Shock vector did not influence first or second shock success rates (82.0% AP vs 76.6% AA; P = 0.46). MPA was successful in 16 of 20 (80%) who failed in both (patches/paddles), with 360 J required in six of seven cases.
CONCLUSION
Routine use of adhesive patches at 200 J is inadequate in obesity. Strategies that improve success include the use of paddles, MPA, and escalation to 360 J.",2019,First or second shock success was 43 of 63 (68.2%) for patches and 56 of 62 (90.3%) for paddles (P = 0.002).,"['20 patients with BMI of 35 or more, and who failed ECV at 200\u2009J using both patches/paddles underwent a trial of MPA', 'Patients with obesity (BMI\u2009≥\u200930) and PeAF undergoing ECV using a biphasic defibrillator', 'obese patients', 'persistent atrial fibrillation (PeAF', '125 patients were randomized between July 2016 and March 2018']","['MPA', '200-J shock using the alternative modality (patch or paddle', 'modality (adhesive patches or handheld paddles) and shock vector (anteroposterior [AP] or anteroapical [AA', 'Manual Pressure Augmentation (MPA) technique']","['safety and efficacy', 'shock success rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}]",125.0,0.134444,First or second shock success was 43 of 63 (68.2%) for patches and 56 of 62 (90.3%) for paddles (P = 0.002).,"[{'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Voskoboinik', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Moskovitch', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Plunkett', 'Affiliation': 'Department of Emergency Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bloom', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'Department of Cardiology, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chrishan', 'Initials': 'C', 'LastName': 'Nalliah', 'Affiliation': 'Department of Cardiology, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Prabhu', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hariharan', 'Initials': 'H', 'LastName': 'Sugumar', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Paramasweran', 'Affiliation': 'Department of Cardiology, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McLellan', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Liang-Han', 'Initials': 'LH', 'LastName': 'Ling', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Cheng-Yee', 'Initials': 'CY', 'LastName': 'Goh', 'Affiliation': 'Department of Cardiology, Western Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Noaman', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Himawan', 'Initials': 'H', 'LastName': 'Fernando', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Kalman', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Kistler', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre, The Alfred Hospital, Melbourne, Victoria, Australia.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13786']
3647,32125709,Design of the SILICOFCM study: Effect of sacubitril/valsartan vs lifestyle intervention on functional capacity in patients with hypertrophic cardiomyopathy.,"BACKGROUND
Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiovascular disease with a broad spectrum of disease severity. HCM ranges from a benign course to a progressive disorder characterized by angina, heart failure, malignant arrhythmia, syncope, or sudden cardiac death. So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms. While the angiotensin receptor neprilysin inhibitor sacubitril/valsartan has shown to reduce mortality and hospitalization in heart failure with reduced ejection fraction, data on its effect on HCM are sparse.
HYPOTHESIS
A 4-month pharmacological (sacubitril/valsartan) or lifestyle intervention will significantly improve exercise tolerance (ie, peak oxygen consumption) in patients with nonobstructive HCM compared to the optimal standard therapy (control group).
METHODS
SILICOFCM is a prospective, multicenter, open-label, randomized, controlled, three-arm clinical trial (NCT03832660) that will recruit 240 adult patients with a confirmed diagnosis of nonobstructive HCM. Eligible patients are randomized to sacubitril/valsartan, lifestyle intervention (physical activity and dietary supplementation with inorganic nitrate), or optimal standard therapy alone (control group). The primary endpoint is the change in functional capacity (ie, peak oxygen consumption). Secondary endpoints include: (a) Change in cardiac structure and function as assessed by transthoracic echocardiography and cardiac magnetic resonance (MRI imaging), (b) change in biomarkers (ie, CK, CKMB, and NT-proBNP), (c) physical activity, and (d) quality of life.
RESULTS
Until December 2019, a total of 41 patients were recruited into the ongoing SILICOFCM study and were allocated to the study groups and the control group. There was no significant difference in key baseline characteristics between the three groups.
CONCLUSION
The SILICOFCM study will provide novel evidence about the effect of sacubitril/valsartan or lifestyle intervention on functional capacity, clinical phenotype, injury and stretch activation markers, physical activity, and quality of life in patients with nonobstructive HCM.",2020,"So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms.","['patients with hypertrophic cardiomyopathy', 'patients with nonobstructive HCM', '41 patients were recruited into the ongoing SILICOFCM study', '240 adult patients with a confirmed diagnosis of nonobstructive HCM', 'Until December 2019', 'Eligible patients', 'patients with nonobstructive HCM compared to the optimal standard therapy (control group']","['pharmacological (sacubitril/valsartan) or lifestyle intervention', 'sacubitril/valsartan vs lifestyle intervention', 'sacubitril/valsartan, lifestyle intervention (physical activity and dietary supplementation with inorganic nitrate), or optimal standard therapy alone (control group', 'sacubitril/valsartan or lifestyle intervention']","['exercise tolerance (ie, peak oxygen consumption', 'change in functional capacity (ie, peak oxygen consumption', 'functional capacity, clinical phenotype, injury and stretch activation markers, physical activity, and quality of life', ' (a) Change in cardiac structure and function as assessed by transthoracic echocardiography and cardiac magnetic resonance (MRI imaging), (b) change in biomarkers (ie, CK, CKMB, and NT-proBNP), (c) physical activity, and (d) quality of life', 'functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic Cardiomyopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]",240.0,0.0563467,"So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tafelmeier', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baessler', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Unsoeld', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Preveden', 'Affiliation': 'Medical Faculty, University of Novi Sad, Novi Sad, Serbia and Institute of cardiovascular diseases of Vojvodina, Sremska Kamenica, Serbia.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Barlocco', 'Affiliation': 'Careggi University Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tomberli', 'Affiliation': 'Careggi University Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Dejana', 'Initials': 'D', 'LastName': 'Popovic', 'Affiliation': 'Cardiology Department, Clinical Centre of Serbia, Faculties of Medicine and Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brennan', 'Affiliation': 'Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Guy A', 'Initials': 'GA', 'LastName': 'MacGowan', 'Affiliation': 'Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Arsen', 'Initials': 'A', 'LastName': 'Ristic', 'Affiliation': 'Cardiology Department, Clinical Centre of Serbia, Faculties of Medicine and Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Velicki', 'Affiliation': 'Medical Faculty, University of Novi Sad, Novi Sad, Serbia and Institute of cardiovascular diseases of Vojvodina, Sremska Kamenica, Serbia.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Olivotto', 'Affiliation': 'Careggi University Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Djordje G', 'Initials': 'DG', 'LastName': 'Jakovljevic', 'Affiliation': 'Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Maier', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}]",Clinical cardiology,['10.1002/clc.23346']
3648,32123978,Patient-Reported Outcomes and Long-Term Results of a Randomized Controlled Trial Comparing Single-Port Versus Conventional Laparoscopic Inguinal Hernia Repair.,"BACKGROUND
Surgical techniques for inguinal hernia repair have evolved rapidly from open methods to conventional laparoscopic totally extra-peritoneal (CTEP) and recently single-port TEP (STEP). As there is currently no randomized controlled trial (RCT) reporting long-term patient-reported outcomes between CTEP and STEP, we reviewed patients who were randomized to CTEP or STEP 5 years after surgery.
METHODS
Telephone interviews were administered to patients with primary unilateral inguinal hernia recruited for the RCT comparing CTEP and STEP in 2011. The modified Body Image Questionnaire was used to measure long-term patient-reported outcomes.
RESULTS
Forty-two out of forty-nine of the STEP group and forty-one out of fifty of the CTEP group responded to phone interviews. Median follow-up time, demographic data and clinical outcomes were comparable between both groups. The Body Image Score (5-20: 5-least dissatisfied, 20-most dissatisfied; BIS score ± SD, STEP vs. CTEP, 5.33 ± 0.90 vs. 7.17 ± 1.87, p < 0.001) and Cosmetic Score (2-20: 2-least satisfied, 20-most satisfied; CS score ± SD, STEP vs. CTEP, 19.05 ± 1.31 vs. 15.87 ± 1.57, p < 0.001) were superior in the STEP group. Similarly, self-reported scar perception (1-cannot be seen, 2-can barely be seen, 3-visible; scar perception score ± SD, STEP vs. CTEP, 1.29 ± 0.51 vs. 2.55 ± 0.64, p < 0.001) and overall experience score (1-least satisfied, 10-most satisfied; overall satisfaction score ± SD, STEP vs. CTEP, 9.57 ± 0.67 vs. 8.22 ± 0.94, p < 0.001) were superior in the STEP group.
CONCLUSION
Patients who underwent STEP reported superior cosmetic and satisfaction scores and comparable surgical outcomes 5 years after surgery compared to the CTEP group. STEP should be strongly considered in patients who are concerned about long-term cosmetic outcomes and should be offered if surgical expertise is available. Trial registration NCT02302937.",2020,"CONCLUSION
Patients who underwent STEP reported superior cosmetic and satisfaction scores and comparable surgical outcomes 5 years after surgery compared to the CTEP group.","['Telephone interviews were administered to patients with primary unilateral inguinal hernia recruited for the RCT comparing CTEP and STEP in 2011', 'Forty-two out of forty-nine of the STEP group and forty-one out of fifty of the']","['Single-Port Versus Conventional Laparoscopic Inguinal Hernia Repair', 'CTEP', 'conventional laparoscopic totally extra-peritoneal (CTEP']","['Cosmetic Score', 'superior cosmetic and satisfaction scores', 'overall experience score', 'scar perception', 'Body Image Score', 'Median follow-up time, demographic data and clinical outcomes']","[{'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}]","[{'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.160414,"CONCLUSION
Patients who underwent STEP reported superior cosmetic and satisfaction scores and comparable surgical outcomes 5 years after surgery compared to the CTEP group.","[{'ForeName': 'Daryl Kai Ann', 'Initials': 'DKA', 'LastName': 'Chia', 'Affiliation': 'Department of Surgery, University Surgical Cluster, National University Health System, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lomanto', 'Affiliation': 'Department of Surgery, University Surgical Cluster, National University Health System, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Wijerathne', 'Affiliation': 'Department of Surgery, University Surgical Cluster, National University Health System, 1E Kent Ridge Road, Singapore, 119228, Singapore. sujithwijerathne@gmail.com.'}]",World journal of surgery,['10.1007/s00268-020-05443-z']
3649,32124032,Accuracy of tibial positioning in the frontal plane: a prospective study comparing conventional and innovative techniques in total knee arthroplasty.,"BACKGROUND
Coronal alignment of the tibial component determines functional outcome and survival in total knee arthroplasty (TKA). Innovative techniques for tibial instrumentation have been developed to improve accuracy and reduce the rate of outliers.
METHODS
In a prospective study, 300 patients were allocated to four different groups using a randomization process (two innovative and two conventional) techniques of tibial instrumentation (conventional: extramedullary, intramedullary; innovative: navigation and patient-specific instrumentation (PSI); n = 75 for each group). The aims were to reconstruct the medial proximal tibial angle (MPTA) to 90° and the mechanical tibio-femoral axis (mTFA) to 0°. Both angles were evaluated and compared between all groups three months after the surgery. Patients who presented with a postoperative mTFA > 3° were classified as outliers.
RESULTS
The navigation and intramedullary technique both demonstrated that they were significantly more precise in reconstructing a neutral mTFA and MPTA compared to the other two techniques. The odd's ratio (OR) for producing outliers was highest for the PSI method (PSI OR = 5.5, p < 0.05; extramedullary positioning OR = 3.7, p > 0.05; intramedullary positioning OR = 1.7, p > 0.05; navigation OR = 0.04, p < 0.05). We could only observe significant differences between pre- and postoperative MPTA in the navigation and intramedullary group. The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively.
CONCLUSION
The navigation and intramedullary instrumentation provided the precise positioning of the tibial component. Outliers were most common within the PSI and extramedullary technique. Optimal alignment is dependent on the technique of tibial instrumentation and tibial component positioning determines the accuracy in TKA since mTFA correlated with MPTA pre- and postoperatively.",2020,"The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively.
","['Patients who presented with a postoperative mTFA\u2009>\u20093° were classified as outliers', 'total knee arthroplasty (TKA', 'total knee arthroplasty', '300 patients']","['tibial positioning', 'randomization process (two innovative and two conventional) techniques of tibial instrumentation (conventional: extramedullary, intramedullary; innovative: navigation and patient-specific instrumentation (PSI', 'conventional and innovative techniques']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1706489', 'cui_str': 'Psi'}]",[],300.0,0.0211651,"The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively.
","[{'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Zahn', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Graef', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany. frank.graef@charite.de.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Conrad', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Perka', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hommel', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03389-4']
3650,31924318,Usefulness of a Structured Adult Education Program in Modifying Markers of Cardiovascular Risk After Acute Myocardial Infarction.,"Patient involvement in therapeutic strategies leading to lifestyle changes and increasing adherence to beneficial treatment is important for high risk coronary artery disease patients. The hypothesis of the present substudy was that a program of education specifically structured to educate postmyocardial infarction patients would lead to measurable differences in specific indices of cardiovascular risk. Post-MI patients were randomly assigned to 2 groups. Patients in the intervention arm attended an 8-week long educational program in addition to usual treatment and controls received standard treatment. Low-density lipoprotein cholesterol, systolic blood pressure, body-mass index, and glycosylated hemoglobin were assessed at baseline and at 12 months (values are reported as median [interquartile range]). One hundred ninety-eight consecutively randomized patients were included in the present substudy. The median change in Low-density lipoprotein cholesterol was -54 (-45 to [-62]) mg/dl in the intervention group as compared with -35 (-28 to [-43]) mg/dl in controls (p <0.001). Systolic blood pressure change was -7.5 (-15.3 to 0.3) mm Hg and -3.0 (-11.8 to 2.8) mm Hg, respectively (p = 0.011). The median change in body-mass index was 0.0 (-3.0 to 3.0) kg/m 2 as compared with 2.0 (-1.0 to 3.9) kg/m 2 , respectively (p = 0.002). The reduction in glycosylated hemoglobin was significant in both groups with a median absolute change of -0.29 (-1.11 to 0.09) % in the intervention group and -0.24 (-0.69 to 0.06) % in controls (p = 0.168). If only diabetic patients were considered, the change was -0.65 (-1.3 to [-0.23]) % in the intervention group versus -0.41 (-0.74 to [-0.07]) % in controls (p = 0.021). In conclusion, a relatively short patient education program may have long-lasting effects on established modifiable markers of cardiovascular risk.",2020,The reduction in glycosylated hemoglobin was significant in both groups with a median absolute change of -0.29 (-1.11 to 0.09) % in the intervention group and -0.24,"['high risk coronary artery disease patients', 'Post-MI patients', 'One hundred ninety-eight consecutively randomized patients were included in the present substudy']","['8-week long educational program in addition to usual treatment and controls received standard treatment', 'Structured Adult Education Program']","['Low-density lipoprotein cholesterol, systolic blood pressure, body-mass index, and glycosylated hemoglobin', 'glycosylated hemoglobin', 'median change in body-mass index', 'median change in Low-density lipoprotein cholesterol', 'Cardiovascular Risk', 'Systolic blood pressure change']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856742', 'cui_str': 'Post MI'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0424936', 'cui_str': 'Adult education (finding)'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",198.0,0.0813373,The reduction in glycosylated hemoglobin was significant in both groups with a median absolute change of -0.29 (-1.11 to 0.09) % in the intervention group and -0.24,"[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giannopoulos', 'Affiliation': 'Cardiology Department, Athens General Hospital ""G. Gennimatas"", Athens, Greece. Electronic address: ggiann@med.uoa.gr.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Karageorgiou', 'Affiliation': 'Second Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Vrachatis', 'Affiliation': 'Cardiology Department, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kousta', 'Affiliation': 'Cardiology Department, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Tsoukala', 'Affiliation': 'Cardiology Department, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Letsas', 'Affiliation': 'Second Department of Cardiology, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Siasos', 'Affiliation': 'First Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Deftereos', 'Affiliation': 'Second Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.12.033']
3651,32015127,Parent coaching increases conversational turns and advances infant language development.,"Parental language input is one of the best predictors of children's language achievement. Parentese, a near-universal speaking style distinguished by higher pitch, slower tempo, and exaggerated intonation, has been documented in speech directed toward young children in many countries. Previous research shows that the use of parentese and parent-child turn-taking are both associated with advances in children's language learning. We conducted a randomized controlled trial to determine whether a parent coaching intervention delivered when the infants are 6, 10, and 14 mo of age can enhance parental language input and whether this, in turn, changes the trajectory of child language development between 6 and 18 mo of age. Families of typically developing 6-mo-old infants ( n = 71) were randomly assigned to intervention and control groups. Naturalistic first-person audio recordings of the infants' home language environment and vocalizations were recorded when the infants were 6, 10, 14, and 18 mo of age. After the 6-, 10-, and 14-mo recordings, intervention, but not control parents attended individual coaching appointments to receive linguistic feedback, listen to language input in their own recordings, and discuss age-appropriate activities that promote language growth. Intervention significantly enhanced parental use of parentese and parent-child turn-taking between 6 and 18 mo. Increases in both variables were significantly correlated with children's language growth during the same period, and children's language outcomes at 18 mo. Using parentese, a socially and linguistically enhanced speaking style, improves children's social language turn-taking and language skills. Research-based interventions targeting social aspects of parent-child interactions can enhance language outcomes.",2020,"Using parentese, a socially and linguistically enhanced speaking style, improves children's social language turn-taking and language skills.",['Families of typically developing 6-mo-old infants ( n = 71'],"['parent coaching intervention', 'individual coaching appointments to receive linguistic feedback, listen to language input in their own recordings, and discuss age-appropriate activities that promote language growth']","['conversational turns and advances infant language development', ""children's social language turn-taking and language skills"", 'parental use of parentese and parent-child turn-taking']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",71.0,0.0397048,"Using parentese, a socially and linguistically enhanced speaking style, improves children's social language turn-taking and language skills.","[{'ForeName': 'Naja', 'Initials': 'N', 'LastName': 'Ferjan Ramírez', 'Affiliation': 'Department of Linguistics, University of Washington, Seattle, WA 98195; naja@uw.edu pkkuhl@uw.edu.'}, {'ForeName': 'Sarah Roseberry', 'Initials': 'SR', 'LastName': 'Lytle', 'Affiliation': 'Institute for Learning & Brain Sciences, University of Washington, Seattle, WA 98195.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Kuhl', 'Affiliation': 'Institute for Learning & Brain Sciences, University of Washington, Seattle, WA 98195; naja@uw.edu pkkuhl@uw.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1921653117']
3652,30768414,Trajectories of Symptom Change in the Treatment for Adolescents With Depression Study.,"OBJECTIVE
Depression is the most prominent mental health disorder among youth and has a profound impact with respect to morbidity and mortality if not addressed. The Treatment for Adolescent Depression Study (TADS) is one of the largest randomized controlled trials that compared the effectiveness of four treatments: cognitive-behavioral therapy (CBT); fluoxetine (FLX); combined cognitive-behavioral and fluoxetine treatment (COMB); and placebo (PBO). However, meaningful heterogeneous treatment courses are masked by these group mean comparisons of treatment impact. The present study sought to characterize the acute phase symptom trajectories of the depressed teens enrolled in TADS and to explore predictors of these trajectories, including TADS treatment condition.
METHOD
The TADS sample of 439 adolescent participants diagnosed with major depressive disorder was subjected to growth mixture modeling (GMM) to evaluate subgroups of adolescents with unique trajectories of depression symptom change.
RESULTS
Growth mixture modeling revealed three unique classes of adolescents: (1) a high-severity class with early significant improvement; (2) a high-severity class with limited symptom change; and (3) a moderate severity class with late significant improvement. Baseline predictors of class membership included treatment condition, sex, age, stage of change, depression severity, number of comorbid disorders, hopelessness, melancholia, suicidality, and cognitive distortions.
CONCLUSION
Results of this study may have implications for the selection of which treatment to use for which depressed adolescent.
CLINICAL TRIAL REGISTRATION INFORMATION
Treatment for Adolescents With Depression Study (TADS); https://clinicaltrials.gov/; NCT00006286.",2019,"RESULTS
Growth mixture modeling revealed three unique classes of adolescents: (1) a high-severity class with early significant improvement; (2) a high-severity class with limited symptom change; and (3) a moderate severity class with late significant improvement.","['439 adolescent participants diagnosed with major depressive disorder', 'Adolescents With Depression Study']","['growth mixture modeling (GMM', 'cognitive-behavioral therapy (CBT); fluoxetine (FLX); combined cognitive-behavioral and fluoxetine treatment (COMB); and placebo (PBO', 'TADS']","['treatment condition, sex, age, stage of change, depression severity, number of comorbid disorders, hopelessness, melancholia, suicidality, and cognitive distortions']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0061773', 'cui_str': 'GMM'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0025193', 'cui_str': 'Melancholia'}, {'cui': 'C0332482', 'cui_str': 'Abnormal shape'}]",439.0,0.0253511,"RESULTS
Growth mixture modeling revealed three unique classes of adolescents: (1) a high-severity class with early significant improvement; (2) a high-severity class with limited symptom change; and (3) a moderate severity class with late significant improvement.","[{'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Scott', 'Affiliation': 'Indiana University, Bloomington, IN; Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Lewis', 'Affiliation': 'Indiana University, Bloomington, IN; Kaiser Permanente Washington Health Research Institute, Seattle, WA; University of Washington School of Medicine, Seattle. Electronic address: cara.c.lewis@kp.org.'}, {'ForeName': 'C Nathan', 'Initials': 'CN', 'LastName': 'Marti', 'Affiliation': 'Abacist Analytics, Austin, TX; University of Texas, Austin.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.07.908']
3653,31338640,"Impact of a topical lotion, CG428, on permanent chemotherapy-induced alopecia in breast cancer survivors: a pilot randomized double-blind controlled clinical trial (VOLUME RCT).","PURPOSE
This study aimed to evaluate the impact of a topical lotion (CG428) on hair thickness and density in breast cancer survivors with permanent chemotherapy-induced alopecia (PCIA).
METHODS
The study was a double-blind, randomized controlled trial which conducted from February 2016 to December 2016 at the Samsung Comprehensive Cancer Center in Seoul, South Korea. Breast cancer patients with PCIA were randomized on average of 3.5 years after chemotherapy. Topical lotion (Batch DT023) is a botanical drug under development containing a novel patented blend of 4 botanical ingredients: citrus, cocoa, guarana, and onion. Participants were asked to self-apply the study product or placebo twice per day for 6 months. Changes in hair density and thickness were assessed using a noninvasive bioengineering device, and patient-reported outcomes were evaluated at 3 and 6 months after randomization.
RESULTS
A total of 35 patients were randomized to intervention (N = 18) or placebo (N = 17). Patients in the intervention group were older than those in the placebo group (52.1 vs. 41.6 years; P < 0.001). The mean hair density (SD) at baseline was 97.6 (6.4) and 126.8 (30.3) hairs/cm 2 in the intervention and placebo group, respectively (P = 0.005). The corresponding values for hair thickness were 49.9 (12.7) and 48.1 (8.4) μm, respectively. After 6 months, hair density had increased by 34.7 and 24.9% compared with baseline in the intervention and control groups, respectively (P = 0.37). Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23). Similar findings were observed after age adjustment.
DISCUSSION
In this pilot randomized clinical trial, we observed safety, tolerability, and a trend toward the efficacy of CG428 vs. placebo, especially regarding hair density and self-reported improvement.",2020,"Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23).","['35 patients', 'Breast cancer patients with PCIA', 'breast cancer survivors', 'breast cancer survivors with permanent chemotherapy-induced alopecia (PCIA', 'conducted from February 2016 to December 2016 at the Samsung Comprehensive Cancer Center in Seoul, South Korea']","['topical lotion (CG428', 'permanent chemotherapy-induced alopecia', 'CG428 vs. placebo', 'placebo', 'topical lotion, CG428', 'Topical lotion (Batch DT023']","['hair density and thickness', 'hair density', 'safety, tolerability', 'mean hair density (SD', 'hair thickness and density', 'corresponding values for hair thickness', 'hair thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C0991552', 'cui_str': 'Topical Lotion'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.617278,"Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23).","[{'ForeName': 'Danbee', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea.'}, {'ForeName': 'Im-Ryung', 'Initials': 'IR', 'LastName': 'Kim', 'Affiliation': 'Cancer Education Center, Samsung Comprehensive Cancer Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.'}, {'ForeName': 'Young Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Departments of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 2024 E. Monument St, Baltimore, MD, USA.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Guallar', 'Affiliation': 'Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea. jinseok.ahn@samsung.com.'}, {'ForeName': 'Juhee', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea. jcho@skku.edu.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04982-z']
3654,32105112,Bidirectional relationship of posttraumatic stress disorder (PTSD) symptom severity and alcohol use over the course of integrated treatment.,"Posttraumatic stress disorder (PTSD) and alcohol use disorder commonly co-occur. Little is known about how symptoms of one affect subsequent week symptoms of the other during the course of integrated treatment for both disorders. The sample included 107 veterans who were randomized to receive either Concurrent Treatment of PTSD and Substance Use Disorder Using Prolonged Exposure (COPE; an exposure-based trauma focused treatment) or Seeking Safety (SS; a present-focused coping skills-based treatment) and completed measures of PTSD and alcohol use at every other session. Multilevel models estimated the prospective associations between PTSD and alcohol use during treatment. Results indicated that greater PTSD symptom severity was associated with greater future alcohol use ( b = 0.20, p = .024), and greater alcohol use was associated with greater future PTSD symptom severity ( b = 0.13, p = .003). The effect size for PTSD symptoms to future alcohol use was larger than the reciprocal relationship. When using lagged PTSD severity to predict future drinking, results revealed that clinically significant differences in PTSD severity levels were associated with comparably large differences in drinking. Treatment condition did not moderate the effect of PTSD symptom severity on alcohol use (or the reciprocal relationship). Findings lend support to the mutual maintenance model of addiction. Integrated treatments that treat both PTSD and alcohol use may be preferential to sequential model of care where individuals are expected to achieve abstinence or reduced use prior to receiving trauma-focused treatment. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Treatment condition did not moderate the effect of PTSD symptom severity on alcohol use (or the reciprocal relationship).,['107 veterans'],['Concurrent Treatment of PTSD and Substance Use Disorder Using Prolonged Exposure (COPE; an exposure-based trauma focused treatment) or Seeking Safety (SS; a present-focused coping skills-based treatment) and completed measures of PTSD and alcohol use at every other session'],"['future PTSD symptom severity', 'PTSD severity levels', 'PTSD symptom severity']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.00657575,Treatment condition did not moderate the effect of PTSD symptom severity on alcohol use (or the reciprocal relationship).,"[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Tripp', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Worley', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Straus', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Angkaw', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'School of Medicine.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000564']
3655,31397866,Operative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears: A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trial.,"Importance
Rotator cuff disorders remain the most common cause of shoulder pain and are among the most common reasons for patients to seek care in primary and specialty settings. Although operative and nonoperative treatments are offered to patients with atraumatic rotator cuff tears, there is a lack of evidence to support operative vs nonoperative treatment. This paucity of evidence has been highlighted by several professional agencies and experts.
Objective
To perform a pragmatic randomized clinical trial, the Arthroscopic Rotator Cuff trial, comparing pain and functional outcomes in patients undergoing operative vs nonoperative treatment for atraumatic rotator cuff tears, and assessing heterogeneity of treatment effects by age and tear size.
Design, Setting, and Participants
Trial protocol of the Arthroscopic Rotator Cuff trial. This pragmatic randomized clinical trial of an estimated 700 patients is adequately powered to accomplish its aims with 488 patients. Primary analysis will be conducted on an intent-to-treat population in the context of a mixed model. The multicenter trial started recruitment in 2018 with a 1-year follow-up duration. Patients aged 50 years or older to younger than 85 years with magnetic resonance imaging-confirmed atraumatic rotator cuff tears that are suitable for either operative or nonoperative treatment will be enrolled. Block randomization will be performed and stratified by site, age, and tear size.
Intervention
Nonoperative treatment consists of an approximately 3-month standardized physical therapy program, whereas operative treatment consists of rotator cuff surgery followed by approximately 4 months of postoperative rehabilitation.
Main Outcomes and Measures
The primary outcome is patient-reported Shoulder Pain and Disability Index score, and the secondary outcome is American Shoulder and Elbow Surgeons Standardized Shoulder Form score measured at 1 year of follow-up.
Discussion
The Arthroscopic Rotator Cuff trial is ongoing, and 12 sites with more than 40 physicians are currently recruiting patients. Although there is variation by site, as of May 2, 2019, 13% of all patients screened (787 of 6293) were eligible for the trial, and 9% of eligible patients (74 of 787) were recruited. Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears.
Trial Registration
ClinicalTrials.gov identifier: NCT03295994.",2019,"Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears.
","['patients with atraumatic rotator cuff tears', 'Atraumatic Rotator Cuff Tears', '700 patients', 'atraumatic rotator cuff tears', 'patients undergoing operative vs nonoperative treatment for atraumatic rotator cuff tears', '2019, 13% of all patients screened (787 of 6293) were eligible for the trial, and 9% of eligible patients (74 of 787) were recruited', '488 patients', '2018 with a 1-year follow-up duration', 'Patients aged 50 years or older to younger than 85 years with']","['Arthroscopic Rotator Cuff trial', 'magnetic resonance imaging-confirmed atraumatic rotator cuff tears']","['patient-reported Shoulder Pain and Disability Index score, and the secondary outcome is American Shoulder and Elbow Surgeons Standardized Shoulder Form score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",700.0,0.226756,"Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears.
","[{'ForeName': 'Nitin B', 'Initials': 'NB', 'LastName': 'Jain', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Ayers', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Koudelková', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dickinson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Derryberry', 'Affiliation': 'Stakeholder advisory board, Boston, Massachusetts.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Kuhn', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2019.9050']
3656,32155372,Re: Safety of High-Dose Vitamin D Supplementation: Secondary Analysis of a Randomized Controlled Trial.,,2020,,[],['High-Dose Vitamin D Supplementation'],[],[],"[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],,0.655611,,"[{'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Assimos', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000000997']
3657,31387013,The effects of shame on subsequent reactions to a trauma analog.,"The current study examined the effects of experimentally-induced shame on subsequent reactions to a trauma analog. Participants were 88 college-aged women randomly assigned to a shame prime condition or to a control (neutral) condition. Participants then were presented with an analog trauma audiotape depicting dating violence. Participants reported intrusive thoughts relating to the trauma analog in the two days following the procedure. Negative (shame, guilt) and positive (pride, positive affect) emotions were monitored throughout the procedure. Results indicated that the shame prime successfully increased shame in the Shame condition alone. After the trauma analog, increases in shame were noted in both conditions. In contrast, guilt reduced in the Shame condition, while this emotion increased in the Control condition, contrary to hypothesis. Shame and guilt were somewhat volatile for participants in the Shame condition in the two days following the lab procedure, while individuals in the Control condition reported steadily decreasing levels of these emotions. No between-condition differences were noted in the frequency of intrusions in the two days following the laboratory procedure, contrary to hypothesis. Results are discussed in light of our current understanding of shame and its role in PTSD, with suggestions to guide future research.",2019,"Shame and guilt were somewhat volatile for participants in the Shame condition in the two days following the lab procedure, while individuals in the Control condition reported steadily decreasing levels of these emotions.","['Participants then were presented with an analog trauma audiotape depicting dating violence', 'Participants were 88 college-aged women randomly assigned to a']",['shame prime condition or to a control (neutral) condition'],"['Shame and guilt', 'shame', 'Negative (shame, guilt) and positive (pride, positive affect) emotions']","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0004295', 'cui_str': 'Audiotapes'}, {'cui': 'C4046106', 'cui_str': 'Dating Violence'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",,0.0232906,"Shame and guilt were somewhat volatile for participants in the Shame condition in the two days following the lab procedure, while individuals in the Control condition reported steadily decreasing levels of these emotions.","[{'ForeName': 'J Gayle', 'Initials': 'JG', 'LastName': 'Beck', 'Affiliation': 'Department of Psychology, The University of Memphis, United States. Electronic address: jgbeck@memphis.edu.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Dodson', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Pickover', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Woodward', 'Affiliation': 'Department of Psychological Sciences, Western Kentucky University, United States.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Lipinski', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}, {'ForeName': 'Han N', 'Initials': 'HN', 'LastName': 'Tran', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102108']
3658,31731467,Coffee Ingestion Improves 5 km Cycling Performance in Men and Women by a Similar Magnitude.,"Caffeine is a well-established ergogenic aid, although research to date has predominantly focused on anhydrous caffeine, and in men. The primary aim of the present study was to investigate the effect of coffee ingestion on 5 km cycling time trial performance, and to establish whether sex differences exist. A total of 38 participants (19 men and 19 women) completed a 5 km time trial following the ingestion of 0.09 g·kg -1 coffee providing 3 mg·kg -1 of caffeine (COF), a placebo (PLA), in 300 mL of water, or control (CON). Coffee ingestion significantly increased salivary caffeine levels ( p < 0.001; η P 2 = 0.75) and, overall, resulted in improved 5 km time trial performance ( p < 0.001; η P 2 = 0.23). Performance following COF (482 ± 51 s) was faster than PLA (491 ± 53 s; p = 0.002; d = 0.17) and CON (487 ± 52 s; p =0.002; d = 0.10) trials, with men and women both improving by approximately 9 seconds and 6 seconds following coffee ingestion compared with placebo and control, respectively. However, no differences were observed between CON and PLA ( p = 0.321; d = 0.08). In conclusion, ingesting coffee providing 3 mg·kg -1 of caffeine increased salivary caffeine levels and improved 5 km cycling time trial performance in men and women by a similar magnitude.",2019,"Coffee ingestion significantly increased salivary caffeine levels ( p < 0.001; η P 2 = 0.75) and, overall, resulted in improved 5 km time trial performance ( p < 0.001; η P 2 = 0.23).","['38 participants (19 men and 19 women', 'Men and Women by a Similar Magnitude']","['Caffeine', 'coffee ingestion', 'ingestion of 0.09 g·kg -1 coffee providing 3 mg·kg -1 of caffeine (COF), a placebo (PLA), in 300 mL of water, or control (CON', 'placebo', 'Coffee Ingestion']","['5 km time trial performance', 'salivary caffeine levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517419', 'cui_str': 'Zero point zero nine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",38.0,0.391562,"Coffee ingestion significantly increased salivary caffeine levels ( p < 0.001; η P 2 = 0.75) and, overall, resulted in improved 5 km time trial performance ( p < 0.001; η P 2 = 0.23).","[{'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Clarke', 'Affiliation': 'School of Life Sciences, Faculty of Health and Life Sciences, Coventry University, Coventry CV12DS, UK.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Kirwan', 'Affiliation': 'School of Life Sciences, Faculty of Health and Life Sciences, Coventry University, Coventry CV12DS, UK.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Richardson', 'Affiliation': 'School of Life Sciences, Faculty of Health and Life Sciences, Coventry University, Coventry CV12DS, UK.'}]",Nutrients,['10.3390/nu11112575']
3659,32081690,Comparison of Clinical Outcomes of CO 2 Laser-Assisted Blepharoplasty Using Two Different Methods.,"PURPOSE
Numerous methods have been developed for blepharoplasty, including carbon dioxide (CO 2 ) laser-assisted blepharoplasty. Although the superiority of CO 2 laser compared with the scalpel for blepharoplasty has been proposed, to the best of our knowledge, no study has compared the clinical outcomes of blepharoplasty with the CO 2 laser alone versus the combined use of a scalpel and CO 2 laser.
PATIENTS AND METHODS
In the present randomized clinical trial, 21 healthy patients underwent bilateral upper eyelid blepharoplasty. For each patient, an initial skin incision was made using the CO 2 laser (setting, continuous emission; ultrapulse mode; 3 W of power) on 1 side and a scalpel on the other side. The remaining blepharoplasty steps were conducted using the CO 2 laser (setting, continuous emission; 9 W of power) in both groups. The patients were evaluated on postoperative days 1, 3, 7, 14, and 30 using the postoperative repair criteria, including edema and ecchymosis. The Manchester scar scale was used to evaluate the results at 60 days after surgery.
RESULTS
Our comparison of the 2 methods showed no significant differences at 1 month after surgery using the evaluation criteria. The scar index was not significantly different after 60 days, despite lower scores in the scalpel group.
CONCLUSIONS
In upper eyelid blepharoplasty, making an initial incision with a scalpel, followed by use of a laser provides advantages similar to those found by performing the entire procedure with a CO 2 laser alone.",2020,"The scar index was not significantly different after 60 days, despite lower scores in the scalpel group.
",['21 healthy patients underwent'],"['bilateral upper eyelid blepharoplasty', 'carbon dioxide (CO 2 ) laser-assisted blepharoplasty', 'CO 2 Laser-Assisted Blepharoplasty']","['scar index', 'Manchester scar scale', 'edema and ecchymosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure (body structure)'}, {'cui': 'C0197213', 'cui_str': 'Blepharoplasty'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222045'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",21.0,0.0189338,"The scar index was not significantly different after 60 days, despite lower scores in the scalpel group.
","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Fallahi', 'Affiliation': 'Oral Maxillofacial Surgeon, Private Practice; Dental Research Center, Research Institute of Dental Sciences and School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Seied Omid', 'Initials': 'SO', 'LastName': 'Keyhan', 'Affiliation': 'Oral Maxillofacial Surgeon, National Advance Center for Craniomaxillofacial Reconstruction, Craniomaxillofacial Research Center, Tehran University of Medical Sciences; and Regenerative Medicine and Stem Cell Research Network, Shahaid Beheshti University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Niamtu', 'Affiliation': 'Oral Maxillofacial Surgeon, Private Practice; Fellow, American Academy of Cosmetic Surgery, Chicago, IL; and Diplomat, American Board of Cosmetic Facial Surgery, Philadelphia, PA.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Alikazemi', 'Affiliation': 'Oral Maxillofacial Surgeon and Assistance Professor, Department of Oral and Maxillofacial Surgery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Raha', 'Initials': 'R', 'LastName': 'Habibagahi', 'Affiliation': 'PhD of Biomaterials, Orthodontic Research Center, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Raha2979@yahoo.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.015']
3660,30819379,Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial.,"OBJECTIVES
This study sought to investigate sex differences in outcomes and responses to spironolactone in patients with heart failure with preserved ejection fraction (HFpEF).
BACKGROUND
HFpEF affects women more frequently than men. Sex differences in responses to effects of mineralocorticoid antagonists have not been reported.
METHODS
This was an exploratory, post hoc, non-pre-specified analysis of the TOPCAT (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function) trial. Subjects with symptomatic HF and a left ventricular ejection fraction ≥45% were randomized to spironolactone or placebo therapy. Subjects enrolled from the Americas were analyzed. The primary outcome was a composite of cardiovascular (CV) death, cardiac arrest, or HF hospitalization. Secondary outcomes included all-cause mortality, CV, and non-CV mortality and CV, HF, and non-CV hospitalization. Sex differences in outcomes and treatment effects were determined using time-to-event analysis.
RESULTS
In total, 882 of 1,767 subjects (49.9%) were women. Women were older with fewer comorbidities but worse patient-reported outcomes. There were no sex differences in outcomes in the placebo arm or in response to spironolactone for the primary outcome or its components. Spironolactone therapy was associated with reduced all-cause mortality in women (hazard ratio: 0.66; p = 0.01) but not in men (p interaction = 0.02).
CONCLUSIONS
In TOPCAT, women and men presented with different clinical profiles and similar clinical outcomes. The interaction between spironolactone and sex in TOPCAT overall and in the present analysis was nonsignificant for the primary outcome, but there was a reduction in all-cause mortality associated with spironolactone therapy in women, with a significant interaction between sex and treatment arm. Prospective evaluation is needed to determine whether spironolactone therapy may be effective for treatment of HFpEF in women. (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT]; NCT00094302).",2019,There were no sex differences in outcomes in the placebo arm or in response to spironolactone for the primary outcome or its components.,"['In total, 882 of 1,767 subjects (49.9%) were women', 'Subjects with symptomatic HF and a left ventricular ejection fraction', 'women', 'Subjects enrolled from the Americas were analyzed', 'patients with heart failure with preserved ejection fraction (HFpEF', 'Adults With Heart Failure and Preserved Systolic Function) trial', 'Adults With Heart Failure and Preserved Systolic Function [TOPCAT', 'Heart Failure']","['placebo', 'TOPCAT (Aldosterone Antagonist Therapy', 'spironolactone therapy', 'spironolactone or placebo', 'Preserved Ejection Fraction', 'Spironolactone', 'Aldosterone Antagonist Therapy', 'spironolactone']","['cause mortality', 'cause mortality, CV, and non-CV mortality and CV, HF, and non-CV hospitalization', 'composite of cardiovascular (CV) death, cardiac arrest, or HF hospitalization']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}]",1767.0,0.321905,There were no sex differences in outcomes in the placebo arm or in response to spironolactone for the primary outcome or its components.,"[{'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Merrill', 'Affiliation': 'Department of Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Sweitzer', 'Affiliation': 'Division of Cardiology, Sarver Heart Center, University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kao', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado. Electronic address: David.Kao@ucdenver.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.01.003']
3661,32011942,Evidence-Based Community Health Worker Program Addresses Unmet Social Needs And Generates Positive Return On Investment.,"Interventions that address socioeconomic determinants of health are receiving considerable attention from policy makers and health care executives. The interest is fueled in part by expected returns on investment. However, many current estimates of returns on investment are likely overestimated, because they are based on pre-post study designs that are susceptible to regression to the mean. We present a return-on-investment analysis that is based on a randomized controlled trial of Individualized Management for Patient-Centered Targets (IMPaCT), a standardized community health worker intervention that addresses unmet social needs for disadvantaged people. We found that every dollar invested in the intervention would return $2.47 to an average Medicaid payer within the fiscal year.",2020,We found that every dollar invested in the intervention would return $2.47 to an average Medicaid payer within the fiscal year.,['disadvantaged people'],[],[],[],[],[],,0.0268478,We found that every dollar invested in the intervention would return $2.47 to an average Medicaid payer within the fiscal year.,"[{'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Kangovi', 'Affiliation': 'Shreya Kangovi ( shreya. kangovi@pennmedicine. upenn. edu ) is an associate professor in the Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania, in Philadelphia.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Mitra', 'Affiliation': 'Nandita Mitra is a professor in the Department of Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grande', 'Affiliation': 'David Grande is an associate professor in the Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'Judith A. Long is a professor in the Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'David A. Asch is a professor in the Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania.'}]",Health affairs (Project Hope),['10.1377/hlthaff.2019.00981']
3662,32180248,Variance estimation for the Kappa statistic in the presence of clustered data and heterogeneous observations.,"We present a methodology motivated by a controlled trial designed to validate SPOT GRADE, a novel surgical bleeding severity scale. Briefly, the study was designed to quantify inter- and intra-surgeon agreement for characterizing the severity of surgical bleeds via a Kappa statistic. Multiple surgeons were presented with a randomized sequence of controlled bleeding videos and asked to apply the rating system to characterize each wound. Each video was shown multiple times to quantify intra-surgeon reliability, creating clustered data. In addition, videos within the same category may have had different classification probabilities due to changes in blood flow rates and wound sizes. In this work, we propose a new variance estimator for the Kappa statistic, for use in clustered data as well as heterogeneity among items within the same classification category. We then apply this methodology to data from the SPOT GRADE trial.",2020,Multiple surgeons were presented with a randomized sequence of controlled bleeding videos and asked to apply the rating system to characterize each wound.,[],[],['blood flow rates and wound sizes'],[],[],"[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",,0.0251312,Multiple surgeons were presented with a randomized sequence of controlled bleeding videos and asked to apply the rating system to characterize each wound.,"[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Ryan', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, California.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Spotnitz', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Gillen', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, California.'}]",Statistics in medicine,['10.1002/sim.8522']
3663,31403867,"Axitinib in Combination With Toripalimab, a Humanized Immunoglobulin G 4 Monoclonal Antibody Against Programmed Cell Death-1, in Patients With Metastatic Mucosal Melanoma: An Open-Label Phase IB Trial.","PURPOSE
Metastatic mucosal melanoma responds poorly to anti-programmed cell death-1 (PD-1) monotherapy. Vascular endothelial growth factor (VEGF) has been shown to play an important immunosuppressive role in the tumor microenvironment. The combination of VEGF inhibition and PD-1 blockade provides therapeutic opportunities for patients refractory to either therapy alone.
PATIENTS AND METHODS
We conducted a single-center, phase IB trial evaluating the safety and preliminary efficacy of toripalimab, a humanized immunoglobulin G 4 monoclonal antibody against PD-1 in combination with the VEGF receptor inhibitor axitinib in patients with advanced melanoma, including patients with chemotherapy-naïve mucosal melanomas (88%). Patients received toripalimab at 1 or 3 mg/kg via intravenous infusion every 2 weeks, in combination with axitinib 5 mg orally twice a day, in a dose-escalation and cohort-expansion study until confirmed disease progression, unacceptable toxicity, or voluntary withdrawal. The primary objective was safety. Secondary objectives included efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and tumor tissue biomarkers.
RESULTS
Thirty-three patients were enrolled. No dose-limiting toxicities were observed. Ninety-seven percent of patients experienced treatment-related adverse events (TRAEs). The most common TRAEs were mild (grade 1 or 2) and included diarrhea, proteinuria, hand and foot syndrome, fatigue, AST or ALT elevation, hypertension, hypo- or hyperthyroidism, and rash. Grade 3 or greater TRAEs occurred in 39.4% of patients. By the cutoff date, among 29 patients with chemotherapy-naïve mucosal melanoma, 14 patients (48.3%; 95% CI, 29.4% to 67.5%) achieved objective response, and the median progression-free survival time was 7.5 months (95% CI, 3.7 months to not reached) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CONCLUSION
The combination of toripalimab plus axitinib was tolerable and showed promising antitumor activity in patients with treatment-naïve metastatic mucosal melanoma. Patients enrolled in this study were all Asian, and this combination therapy must be validated in a randomized phase III trial that includes a non-Asian population before it can become a standard of care.",2019,The combination of toripalimab plus axitinib was tolerable and showed promising antitumor activity in patients with treatment-naïve metastatic mucosal melanoma.,"['patients with treatment-naïve metastatic mucosal melanoma', 'patients refractory to either therapy alone', '29 patients with chemotherapy-naïve mucosal melanoma', 'Patients With Metastatic Mucosal Melanoma', 'Thirty-three patients were enrolled', 'patients with advanced melanoma, including patients with chemotherapy-naïve mucosal melanomas (88']","['toripalimab', 'toripalimab, a humanized immunoglobulin G 4 monoclonal antibody against PD-1 in combination with the VEGF receptor inhibitor axitinib', 'VEGF inhibition and PD-1 blockade', 'toripalimab plus axitinib']","['diarrhea, proteinuria, hand and foot syndrome, fatigue, AST or ALT elevation, hypertension, hypo- or hyperthyroidism, and rash', 'antitumor activity', 'No dose-limiting toxicities', 'objective response', 'Grade 3 or greater TRAEs', 'adverse events (TRAEs', 'efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and tumor tissue biomarkers', 'median progression-free survival time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement (procedure)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2609423', 'cui_str': 'Hyperthyroidism (SMQ)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",33.0,0.221898,The combination of toripalimab plus axitinib was tolerable and showed promising antitumor activity in patients with treatment-naïve metastatic mucosal melanoma.,"[{'ForeName': 'Xinan', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Xieqiao', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Chi', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Bixia', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Siming', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lian', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""OrigiMed, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiongwen', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Shanghai Junshi Biosciences, Shanghai, People's Republic of China.""}, {'ForeName': 'Huaning', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Shanghai Junshi Biosciences, Shanghai, People's Republic of China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Shanghai Junshi Biosciences, Shanghai, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': ""Shanghai Junshi Biosciences, Shanghai, People's Republic of China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': ""Shanghai Junshi Biosciences, Shanghai, People's Republic of China.""}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Cancer Center, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00210']
3664,31350681,The use of mobile technology and peer navigation to promote adolescent and young adult (AYA) cancer survivorship care: results of a randomized controlled trial.,"PURPOSE
Adolescent and young adult (AYA) cancer survivors experience unique barriers that compromise receipt of survivorship care; therefore, development of innovative educational interventions to improve rates of AYA survivorship care is needed. The efficacy of text-messaging and peer navigation interventions was compared to standard-of-care survivorship educational materials to increase AYAs' (1) late effects knowledge and (2) knowledge, attitudes, and self-efficacy towards seeking survivor-focused care.
METHODS
This was a three-armed, prospective, randomized controlled trial with one control group and two intervention groups. The control group received current standard-of-care educational materials. One intervention group participated in a text-messaging program, and the second participated in a peer navigator program. Participants completed pre- and post-intervention questionnaires. Study outcome variables were quantified using Fisher exact tests, two-sample t tests, exact McNemar tests, conditional logistic regression models, and analysis of covariance.
RESULTS
Seventy-one survivors completed the study (control n = 24; text-messaging n = 23; peer navigation n = 24). Late effects knowledge was high at baseline for all groups. The text-messaging group had increased survivorship care knowledge compared to the control group (p < 0.05); the peer navigation group had increased survivorship care self-efficacy compared to the control group; p < 0.05. Both intervention groups showed increased attitudes towards seeking survivor-focused care compared to the control group (text-messaging p < 0.05; peer navigation p < 0.05).
CONCLUSIONS
Each intervention demonstrated significant benefits compared to the control group.
IMPLICATIONS FOR CANCER SURVIVORS
Given the preliminary effectiveness of both interventions, each can potentially be used in the future by AYA cancer survivors to educate and empower them to obtain needed survivorship care.",2019,The text-messaging group had increased survivorship care knowledge compared to the control group (p < 0.05); the peer navigation group had increased survivorship care self-efficacy compared to the control group; p < 0.05.,"['FOR CANCER SURVIVORS', 'Adolescent and young adult (AYA) cancer survivors', 'adolescent and young adult (AYA) cancer survivorship care']","['mobile technology and peer navigation', 'current standard-of-care educational materials', 'text-messaging and peer navigation interventions', 'text-messaging program, and the second participated in a peer navigator program']","['survivorship care knowledge', 'attitudes towards seeking survivor-focused care', ' (1) late effects knowledge and (2) knowledge, attitudes, and self-efficacy', 'survivorship care self-efficacy']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0038955'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0038955'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1368999', 'cui_str': 'Late effect of'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",71.0,0.0304395,The text-messaging group had increased survivorship care knowledge compared to the control group (p < 0.05); the peer navigation group had increased survivorship care self-efficacy compared to the control group; p < 0.05.,"[{'ForeName': 'Jacqueline N', 'Initials': 'JN', 'LastName': 'Casillas', 'Affiliation': 'Department of Pediatrics, Division of Hematology/Oncology, UCLA David Geffen School of Medicine, 10833 Le Conte Avenue, A2-410 MDCC, Los Angeles, CA, 90095-1752, USA. jcasillas@mednet.ucla.edu.'}, {'ForeName': 'Lindsay F', 'Initials': 'LF', 'LastName': 'Schwartz', 'Affiliation': 'Department of Pediatrics, Division of Hematology/Oncology, UCLA David Geffen School of Medicine, 10833 Le Conte Avenue, A2-410 MDCC, Los Angeles, CA, 90095-1752, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Crespi', 'Affiliation': 'Department of Biostatistics, UCLA Fielding School of Public Health, Los Angeles, CA, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Ganz', 'Affiliation': 'Center for Cancer Prevention and Control Research, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Stuber', 'Affiliation': 'Department of Psychiatry, Resnick Neuropsychiatric Hospital, UCLA David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Bastani', 'Affiliation': 'Center for Cancer Prevention and Control Research, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Alquaddomi', 'Affiliation': 'Department of Computer Science, Cornell University, New York, NY, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Estrin', 'Affiliation': 'Department of Computer Science, Cornell University, New York, NY, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00777-7']
3665,31405924,Distinct Roles of Dopamine and Noradrenaline in Incidental Memory.,"Episodic memory is sensitive to the influence of neuromodulators, such as dopamine and noradrenaline. These influences are considered important in the expression of several known memory biases, though their specific role in memory remains unclear. Using pharmacological agents with relatively high selectivity for either dopamine (400 mg amisulpride) or noradrenaline (40 mg propranolol) we examined their specific contribution to incidental memory. In a double-blind placebo-controlled human study (30 females, 30 males in total), we show that a memory selectivity bias was insensitive to propranolol but sensitive to amisulpride, consistent with a dominant influence from dopamine. By contrast, a putative arousal-induced memory boosting effect was insensitive to amisulpride but was sensitive to propranolol, consistent with a dominant noradrenaline effect. Thus, our findings highlight specific functional roles for dopamine and noradrenaline neurotransmission in the expression of incidental memory. SIGNIFICANCE STATEMENT Why some information is preferentially encoded into memory while other information is not is a central question in cognitive neuroscience. The neurotransmitters dopamine and noradrenaline are often assumed critical in influencing this selectivity, but their specific contributions remain obscure. In this double-blind, placebo-controlled, between-subjects drug study, we investigate the contributions of noradrenaline and dopamine to episodic memory. Using an incidental memory task, we find that blocking dopamine (400 mg amisulpride) eliminates a neural-gain related memory selectivity bias. Blocking noradrenaline function (40 mg propranolol), in contrast, abolishes an arousal-related memory enhancement. In this assessment of dopamine and noradrenaline neuromodulatory effects we reveal their specific contributions to episodic memory.",2019,Using pharmacological agents with relatively high selectivity for either dopamine (400mg amisulpride) or noradrenaline (40mg propranolol) we examined their specific contribution to incidental memory.,"['incidental memory', 'controlled human study (30 females, 30 males in total']","['dopamine (400mg amisulpride) or noradrenaline (40mg propranolol', 'Blocking noradrenaline function (40mg propranolol', 'dopamine and noradrenaline', 'placebo', 'propranolol', 'blocking dopamine (400mg amisulpride', 'amisulpride']",['putative arousal-induced memory boosting effect'],"[{'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0524336,Using pharmacological agents with relatively high selectivity for either dopamine (400mg amisulpride) or noradrenaline (40mg propranolol) we examined their specific contribution to incidental memory.,"[{'ForeName': 'Tobias U', 'Initials': 'TU', 'LastName': 'Hauser', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom, t.hauser@ucl.ac.uk.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Eldar', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Purg', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moutoussis', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Dolan', 'Affiliation': 'Max Planck University College London Centre for Computational Psychiatry and Ageing Research, London WC1B 5EH, United Kingdom.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0401-19.2019']
3666,31384109,"The Impella Device: Historical Background, Clinical Applications and Future Directions.","The Impella device is a catheter-based miniaturized ventricular assist device. Using a retrograde femoral artery access, it is placed in the left ventricle across the aortic valve. The device pumps blood from left ventricle into ascending aorta and helps to maintain a systemic circulation at an upper rate between 2.5 and 5.0 L/min. This results in almost immediate and sustained unloading of the left ventricle, while increasing overall systemic cardiac output. The most common indications for using the Impella device are in the treatment of acute myocardial infarction complicated by cardiogenic shock and to facilitate high risk coronary angioplasty. Other indications include the treatment of cardiomyopathy with acute decompensation, postcardiotomy shock, and off-pump coronary bypass surgery. A growing body of observational and registry data suggest a potentially valuable role for the Impella system in reducing the mortality associated with cardiogenic shock. However, there are, as of yet, no randomized controlled trial data supporting this observation.",2019,The most common indications for using the Impella device are in the treatment of acute myocardial infarction complicated by cardiogenic shock and to facilitate high risk coronary angioplasty.,[],[],['overall systemic cardiac output'],[],[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}]",,0.0611145,The most common indications for using the Impella device are in the treatment of acute myocardial infarction complicated by cardiogenic shock and to facilitate high risk coronary angioplasty.,"[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Glazier', 'Affiliation': 'Department of Cardiology, Wayne State University/Detroit Medical Center, Heart Hospital, Detroit, Michigan.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Kaki', 'Affiliation': 'Department of Cardiology, Wayne State University/Detroit Medical Center, Heart Hospital, Detroit, Michigan.'}]","The International journal of angiology : official publication of the International College of Angiology, Inc",['10.1055/s-0038-1676369']
3667,32186454,"Re: Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy in Patients with Erectile Dysfunction: A Sham-Controlled, Double-Blind, Randomized Prospective Study.",,2020,,['Patients with Erectile Dysfunction'],['Re: Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]",[],,0.308369,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000000991.03']
3668,32186456,Re: Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial.,,2020,,['Overactive Bladder Symptoms in Men'],['Combined Behavioral and Drug Therapy'],[],"[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],,0.16352,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001003.01']
3669,31957640,"The relationship between obesity and sleep timing behavior, television exposure, and dinnertime among elementary school-age children.","STUDY OBJECTIVES
The daily lifestyle behaviors of children have been shown to be associated with obesity. There are limited studies on the association of sleep timing behavior and body mass index (BMI), specifically in elementary school-age children. This study aimed to investigate the relationship between obesity and sleep timing patterns, television exposure time, and dinnertime among elementary school-age children.
METHODS
Children (n = 169) aged 6 to 10 years who were residents of Alabama were recruited for this study. The questionnaires were used to determine the bedtime, wake-up time, television exposure time, and dinnertime of the participants. The participants were categorized into four groups depending on the bedtime and wake-up time behavior habits: early bed/early wake-up (EE); early bed/late wake-up (EL); late bed/early wake-up (LE); and late bed/late wake-up (LL) time. The BMI z-score, television exposure time, and dinnertime of these groups were compared.
RESULTS
The LL group had a significantly higher BMI z-score compared to the EE group. The higher BMI z-score in the LL group may be associated with late bedtime and not late wake-up time. Approximately 71% of children with late bedtime (8:48 pm), 75% of children who watch television for more than 1 hour, and 54% of children who have dinner after 7:00 pm have obesity.
CONCLUSIONS
Daily behavior habits such as late bedtime, increased television exposure, and late dinnertime are associated with obesity.",2020,The LL group had a significantly higher BMI z-score compared to the EE group.,"['Children (n = 169) aged 6 to 10 years who were residents of Alabama were recruited for this study', 'elementary school-age children']",[],"['BMI z-score, television exposure time, and dinnertime', 'higher BMI z-score', 'BMI z-score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0585040', 'cui_str': 'Dinnertime'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0314043,The LL group had a significantly higher BMI z-score compared to the EE group.,"[{'ForeName': 'Chandra M K', 'Initials': 'CMK', 'LastName': 'Venkatapoorna', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Ayine', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Vaithinathan', 'Initials': 'V', 'LastName': 'Selvaraju', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Emily P', 'Initials': 'EP', 'LastName': 'Parra', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Koenigs', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Jeganathan Ramesh', 'Initials': 'JR', 'LastName': 'Babu', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Thangiah', 'Initials': 'T', 'LastName': 'Geetha', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8080']
3670,31923924,"Effects of a Kinect-based physical training program on body composition, functional fitness and depression in institutionalized older adults.","Exergames have already been used as therapeutic tools to enhance both physical and cognitive functions in older adults.
AIM
To evaluate the effects of a Kinect-based physical activity program on the quality of life, depression, functional fitness and body composition in institutionalized older adults.
METHODS
A total of 50 older adults aged >60 years were selected and randomized to a control and video game group. Body composition was determined by means of anthropometric measurements. Quality of life was assessed using the WHOQOL-BREF questionnaire, and depression was classified using the Beck Depression inventory. Functional fitness was assessed using the Arm Curl, Chair Stand, 8-foot up-and-go, sit and reach, and the aerobic endurance test.
RESULTS
After 12 weeks of protocol, we observed a significant improvement in all functional fitness parameters.
CONCLUSIONS
Our findings suggest that a Kinect-based physical activity program seems to positively impact the three domains related to quality of life and directly associated with age (physical, social and psychological domains), and to promote a more active lifestyle in institutions housing older individuals. Geriatr Gerontol Int 2020; ••: ••-••.",2020,"Functional fitness was assessed using the Arm Curl, Chair Stand, 8-foot up-and-go, sit and reach, and the aerobic endurance test.
","['institutionalized older adults', '50 older adults aged >60\u2009years', 'institutions housing older individuals', 'older adults']","['control and video game group', 'Kinect-based physical training program', 'Kinect-based physical activity program']","['Body composition', 'WHOQOL-BREF questionnaire, and depression', 'body composition, functional fitness and depression', 'quality of life, depression, functional fitness and body composition', 'Quality of life', 'Functional fitness', 'functional fitness parameters']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",50.0,0.0146132,"Functional fitness was assessed using the Arm Curl, Chair Stand, 8-foot up-and-go, sit and reach, and the aerobic endurance test.
","[{'ForeName': 'Roberta L', 'Initials': 'RL', 'LastName': 'Rica', 'Affiliation': 'Department of Physical Education, Estacio de Sá University, Vitoria, Brazil.'}, {'ForeName': 'Guilherme L', 'Initials': 'GL', 'LastName': 'Shimojo', 'Affiliation': 'Department of Physical Education, Estacio de Sá University, Vitoria, Brazil.'}, {'ForeName': 'Michelli Css', 'Initials': 'MC', 'LastName': 'Gomes', 'Affiliation': 'Experimental Physiology and Biochemistry Laboratory, Physical Education and Sport Center, Federal University of Espirito Santo, Vitoria, Brazil.'}, {'ForeName': 'Angelica C', 'Initials': 'AC', 'LastName': 'Alonso', 'Affiliation': 'Department of Post-Graduation in Aging Sciences, São Judas Tadeu University, São Paulo, Brazil.'}, {'ForeName': 'Rafael M', 'Initials': 'RM', 'LastName': 'Pitta', 'Affiliation': 'Department of Preventive Medicine, Albert Einstein Hospital, São Paulo, Brazil.'}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Santa-Rosa', 'Affiliation': 'Department of Physical Education, Estacio de Sá University, Vitoria, Brazil.'}, {'ForeName': 'Francisco L', 'Initials': 'FL', 'LastName': 'Pontes Junior', 'Affiliation': 'Department of Post-Graduation in Gerontology, Science, Arts and Humanities School of São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ceschini', 'Affiliation': 'Experimental Physiology and Biochemistry Laboratory, Physical Education and Sport Center, Federal University of Espirito Santo, Vitoria, Brazil.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gobbo', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bergamin', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Bocalini', 'Affiliation': 'Experimental Physiology and Biochemistry Laboratory, Physical Education and Sport Center, Federal University of Espirito Santo, Vitoria, Brazil.'}]",Geriatrics & gerontology international,['10.1111/ggi.13857']
3671,32102033,Trabeculectomy With Extended Subscleral Tunnel Versus Conventional Trabeculectomy in the Management of POAG: A 1-Year Randomized-controlled Trial.,"PRECIS
This clinical trial compares a modified trabeculectomy technique [extended subscleral tunnel (ESST)] with conventional trabeculectomy [subscleral trabeculectomy (SST)] in terms of success rate and bleb morphology. ESST showed comparable results, with lower incidence of bleb-related complications and need for postoperative antiglaucoma medications.
BACKGROUND
To evaluate the outcome of modified trabeculectomy with extended subscleral tunnel ""ESST"" versus conventional subscleral trabeculectomy ""SST"" in the management of uncontrolled primary open-angle glaucoma.
PARTICIPANTS AND METHODS
This is a randomized clinical trial of 40 eyes (40 patients) divided into 2 equal groups. In the first group, a conventional SST with adjuvant 0.3% mitomycin-C was performed. In the second group, the ESST group, an additional 1.00 mm wide longitudinal scleral groove was dissected and excised in the center of the deep scleral bed extending 1.00 mm beyond the posterior margin of the flap. Patients were examined on days 1, 7, 14, 30, 90, 180, and at 1 year, with a special focus on intraocular pressure and bleb morphology. Postoperative ultrasound biomicroscopy was performed to evaluate the surgical area.
RESULTS
Both groups showed a significant reduction in intraocular pressure, with the ESST group showing significantly lower values on days 7, 14, 30, 90, and 180 (P=0.001, 0.004, 0.026, 0.001, and 0.048), but no significant differences on day 1 and at 1 year (P=0.06 and 0.07). The need for postoperative antiglaucoma medications was significantly lower in the ESST group (P=0.043). Visually significant cataract and bleb related complications were more in the SST group (P=0.044 and <0.001). Significantly more eyes in the ESST group showed normal bleb vascularity and wider extent.
CONCLUSIONS
ESST offers a guarded posterior flow with a success rate comparable to that of conventional SST. ESST could minimize bleb-related complications and bleb-dysesthesia with better long-term bleb morphology and vascularity. It could also minimize the need for further adjuvant postoperative antiglaucoma medications.",2020,"Both groups showed significant reduction in IOP with the ESST group showing significantly lower values on days 7,14,30,90 and 180 (P=0.001,0.004,0.026, 0.001,0.048) but no significant differences on day 1 and at 1 year (P=0.06,0.07).",['40 eyes (40 patients) divided into 2 equal groups'],"['Postoperative ultrasound biomicroscopy', 'conventional trabeculectomy (SST', 'modified trabeculectomy technique (ESST', 'modified trabeculectomy with extended subscleral tunnel ""ESST"" versus conventional subscleral trabeculectomy ""SST', 'conventional SST with adjuvant 0.3% mitomycin-C', 'Trabeculectomy with Extended Subscleral Tunnel versus Conventional Trabeculectomy', 'ESST']","['postoperative anti-glaucoma medications', 'Visually significant cataract and bleb related complications', 'normal bleb vascularity and wider extent', 'IOP', 'intraocular pressure (IOP) and bleb morphology']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1301497', 'cui_str': 'Ultrasound Biomicroscopy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C3714607', 'cui_str': 'Filtering bleb'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0543482', 'cui_str': 'morphology'}]",,0.0560337,"Both groups showed significant reduction in IOP with the ESST group showing significantly lower values on days 7,14,30,90 and 180 (P=0.001,0.004,0.026, 0.001,0.048) but no significant differences on day 1 and at 1 year (P=0.06,0.07).","[{'ForeName': 'Riham S H M', 'Initials': 'RSHM', 'LastName': 'Allam', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Karim A', 'Initials': 'KA', 'LastName': 'Raafat', 'Affiliation': ''}, {'ForeName': 'Rehab M', 'Initials': 'RM', 'LastName': 'Abdel-Hamid', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001480']
3672,31379422,The 8-Hour Challenge: Incentivizing Sleep during End-of-Term Assessments.,"Sleep is critical to physical health, mental well-being, attention, and creativity. During the week of final exams, however, fewer than 10% of undergraduate students maintain the recommended average of 8 hours/night (or, even the recommended minimum of 7 hours/night). For students completing multifaceted projects in studio-based majors (e.g., interior design, architecture, graphic design, studio art), anecdotal and questionnaire data suggest that the end-of-semester reduction in sleep duration may be even worse. One potential solution is to offer students an incentive to maintain healthy sleep durations. We offered interior design students, who were enrolled in a freshman-level graphics studio course, an optional extra credit incentive to maintain optimal sleep durations for five nights leading up to the due date of their final project. If participants maintained an average sleep duration of ≥ 8.0 hours for five nights, they would earn extra credit. By contrast, if they slept an average of 7.0-7.9 hours, there would be no grade change, and if they slept an average of ≤ 6.9 hours, they were instructed that they would lose points (no points were actually deducted). Of the 28 students enrolled in the course, 22 students attempted the challenge (78.6%), and we monitored their sleep duration objectively using wristband actigraphy devices. We compared their sleep duration to that of a group of 22 non-incentivized students enrolled in the same program. In the non-incentivized comparison group, very few students averaged 8 hours (9%) or even 7 hours (14%) of sleep per night. In dramatic contrast, the eight-hour challenge increased the percentage of 8-hour and 7-hour sleepers to 59% and 86%, respectively. Participants who took the eight-hour challenge slept an average of 98 minutes more each night than non-incentivized students and 82 minutes more than they self-reported to sleeping during the semester. The substantial increase in nightly sleep duration did not come at a cost to project performance. Individuals who opted in to the sleep challenge performed as well on the final project as students who did not opt in, and students who showed more consistent sleep (i.e., fewer nights of poor sleep followed by rebound sleep) performed better than students who showed inconsistent sleep. Thus, even during highly stressful ""deadline"" weeks, students can maintain healthy sleeping patterns without exacting a cost on their project performance.",2019,"Individuals who opted in to the sleep challenge performed as well on the final project as students who did not opt in, and students who showed more consistent sleep (i.e., fewer nights of poor sleep followed by rebound sleep) performed better than students who showed inconsistent sleep.","['28 students enrolled in the course, 22 students attempted the challenge (78.6', '22 non-incentivized students enrolled in the same program', 'Individuals who opted in to the sleep challenge performed as well on the final project as students who did not opt in, and students who showed more consistent sleep (i.e., fewer nights of poor sleep followed by rebound sleep) performed better than students who showed inconsistent sleep']",[],['nightly sleep duration'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent (qualifier value)'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0128119,"Individuals who opted in to the sleep challenge performed as well on the final project as students who did not opt in, and students who showed more consistent sleep (i.e., fewer nights of poor sleep followed by rebound sleep) performed better than students who showed inconsistent sleep.","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Baylor University.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Scullin', 'Affiliation': 'Baylor University.'}]",Journal of interior design,['10.1111/joid.12135']
3673,32105616,Evaluation of Success of Transport Disc Distraction Osteogenesis and Costochondral Graft for Ramus Condyle Unit Reconstruction in Pediatric Temporomandibular Joint Ankylosis.,"PURPOSE
The costochondral graft (CCG) is considered the reference standard for pediatric temporomandibular joint reconstruction. It has the disadvantages of unpredictable growth, donor site morbidity, and the need for intermaxillary fixation. It has been reported that transport disk distraction osteogenesis (TDDO) can result in the formation of a neocondyle and disc. We performed a randomized trial to measure and compare clinically relevant outcomes of ramus-condyle unit (RCU) reconstruction using CCG and TDDO for pediatric temporomandibular joint ankylosis (TMJA).
MATERIALS AND METHODS
In the present randomized controlled trial (block randomization with a variable block size), pediatric patients with unilateral, nonrecurrent TMJA aged 3 to 16 years who had presented to our unit from December 2015 to June 2017 were enrolled. Instead of temporalis myofascial flap interposition, a buccal fat pad was used to fill the gap created by osteoarthrectomy. The primary outcome parameter was mouth opening. A mouth opening of at least 25 mm at the median follow-up point was considered success. The secondary outcome parameters were occlusion, laterotrusion, protrusion, reankylosis, neocondyle, chin deviation, facial asymmetry, midline shift, and neo-disc formation. Data were analyzed using the independent t test and rank sum test.
RESULTS
A total of 24 patients were enrolled in the CCG and TDDO groups (n = 12 in each group). Trauma (40.9%) was the most common etiology with a slight male preponderance (59.09%). The mean age was 10.32 ± 2.85 years. The average distraction achieved in the TDDO group was 10.42 mm. The median follow-up duration was 31.5 months (range, 24 to 39 months). The mean preoperative maximal incisal opening had improved from 8.5 ± 4.1 and 9.5 ± 7.1 mm in the CCG and TDDO groups preoperatively to 35.7 ± 2.7 and 34.4 ± 8.9 mm, respectively, at the median follow-up point (P < .005). RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed statistically non-significant differences. No reankylosis or open bite was found. The 3-hour delayed gadolinium-enhanced magnetic resonance imaging scan showed successful neo-disc formation.
CONCLUSIONS
Similar success can be achieved in RCU reconstruction using either CCG or TDDO for pediatric TMJA. Both techniques have some advantages and disadvantages. RCU reconstruction using CCG or TDDO results in formation of a neocondyle, maintenance of occlusion, and correction of facial asymmetry.",2020,"RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed nonstatistically significant differences.","['24 patients were enrolled in the CCG and TDDO groups (n\xa0=\xa012 in each group', 'The mean age was 10.32\xa0±\xa02.85\xa0years', 'Pediatric Temporomandibular Joint Ankylosis', 'pediatric patients with unilateral, nonrecurrent TMJA aged 3 to 16\xa0years who had presented to our unit from December 2015 to June 2017 were enrolled']","['transport disk distraction osteogenesis', 'Transport Disc Distraction Osteogenesis and Costochondral Graft', 'ramus-condyle unit (RCU) reconstruction using CCG and TDDO', 'temporalis myofascial flap interposition', 'gadolinium-enhanced magnetic resonance imaging scan']","['mouth opening', 'average distraction', 'mean preoperative maximal incisal opening', 'occlusion, laterotrusion, protrusion, reankylosis, neocondyle, chin deviation, facial asymmetry, midline shift, and neo-disc formation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2931375', 'cui_str': 'Temporomandibular ankylosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0524975', 'cui_str': 'Osteogenesis, Distraction'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0524414', 'cui_str': 'Condyle'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0039487', 'cui_str': 'Temporal Muscle'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441633'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0333056', 'cui_str': 'Protrusion (morphologic abnormality)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C1306710', 'cui_str': 'Facial asymmetry (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",24.0,0.0728373,"RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed nonstatistically significant differences.","[{'ForeName': 'Kamalpreet', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Research Scientist, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India. Electronic address: ajoyroy@hotmail.com.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashu Seith', 'Initials': 'AS', 'LastName': 'Bhalla', 'Affiliation': 'Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravinder M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Professor and Head, Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.029']
3674,31223226,Laparoscopic Ureterolithotomy vs Ureteroscopic Lithotripsy for Large Ureteral Stones.,"Background and Objectives
The purpose of this study was to compare two methods (transperitoneal laparoscopic ureterolithotomy [TLU] and a combination of ureteroscopic lithotripsy [UL] with retrograde intrarenal surgery [RIRS]) designed for the treatment of large proximal ureteral calculi so that their associated complications and stone-free rates could be assessed.
Methods
A total of 100 patients from three different hospitals who were diagnosed with large upper ureteral stones (≥15 mm) were treated via TLU (n = 48) or UL-RIRS (n = 52). They were treated between March 2012 and May 2014. The study compared the complications, success rate, patient characteristics, and the operation time between the two groups.
Results
The immediate stone clearance rate after a single session was higher in the TLU group than in the UL-RIRS group (100% vs 73.1%, P = .005). However, there was no significant difference in the stone-free rates between the two groups three months after the last procedure was performed (100% vs 96.1%, P = .655). Regarding patients with a history of early-failure extracorporeal shock-wave lithotripsy, there was no significant difference in the stone-free rate between the two groups three months after the last procedure (100% vs 94.4%, P > .05). Further, overall complication rates between the groups were not statistically different ( P = .261).
Conclusion
This study demonstrates that TLU is an effective and safe procedure to treat large impacted upper ureteral stones. When compared to UL-RIRS, TLU showed equivalent efficacy and safety, though there were failed first-line treatments.",2019,"The immediate stone clearance rate after a single session was higher in the TLU group than in the UL-RIRS group (100% vs 73.1%, P = .005).",['100 patients from three different hospitals who were diagnosed with large upper ureteral stones (≥15 mm'],"['Laparoscopic Ureterolithotomy vs Ureteroscopic Lithotripsy', 'ureteroscopic lithotripsy [UL', 'retrograde intrarenal surgery [RIRS', 'TLU', 'methods (transperitoneal laparoscopic ureterolithotomy [TLU', 'UL-RIRS']","['complications, success rate, patient characteristics, and the operation time', 'stone-free rate', 'overall complication rates', 'efficacy and safety', 'stone-free rates', 'immediate stone clearance rate']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}]","[{'cui': 'C0812514', 'cui_str': 'Laparoscopic incision of ureter and removal of calculus'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach (qualifier value)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",100.0,0.0746627,"The immediate stone clearance rate after a single session was higher in the TLU group than in the UL-RIRS group (100% vs 73.1%, P = .005).","[{'ForeName': 'Jae Duck', 'Initials': 'JD', 'LastName': 'Choi', 'Affiliation': 'Department of Urology, Eulji General Hospital, Eulji University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seong Il', 'Initials': 'SI', 'LastName': 'Seo', 'Affiliation': 'Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joonbeom', 'Initials': 'J', 'LastName': 'Kwon', 'Affiliation': 'Department of Urology, Daegu Fatima Hospital, Daegu, South Korea.'}, {'ForeName': 'Bum Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2019.00008']
3675,30999058,A text message delivered smoking cessation intervention: Design and rationale of the Text My Quit Study.,"INTRODUCTION
Smoking cessation interventions delivered through mobile technologies offer promise as an effective intervention tool. However, most existing programs have not been empirically tested, were not developed with end-user participation, and/or do not address evidence-based cognitive and behavioral variables shown to enhance smoking cessation in clinical trials. In addition, many programs tested in research trials have required users to access the internet and/or a smartphone app to access all program features, limiting the potential reach of those programs.
METHODS/DESIGN
This study is a randomized controlled trial testing the efficacy of the TMQ intervention for smoking cessation. All participants are randomly assigned to receive 12 weeks of either; (1) a tailored smoking-cessation intervention delivered 100% through text messaging (TMQ), or (2) non-smoking-related text messages serving as a control for contact and subject burden (Mojo). Assessments are conducted at baseline, 3- and 6-month follow-up. The primary outcome is prolonged abstinence using an intent-to-treat approach. To understand why TMQ may be more effective than Mojo, we will test several posited mechanisms of action (i.e., mediators) that may underlie intervention efficacy and will examine use of the TMQ integrated social support (ISS) network. At the end of treatment, semi-structured interviews will be conducted with TMQ participants.
CONCLUSIONS
This study will provide a rigorous test of an innovative smoking cessation program delivered 100% through text messages. Use of mixed methodologies will provide the opportunity to enhance our understanding of the user's experience with TMQ and identify areas for future enhancement and/or expansion.",2019,"All participants are randomly assigned to receive 12 weeks of either; (1) a tailored smoking-cessation intervention delivered 100% through text messaging (TMQ), or (2) non-smoking-related text messages serving as a control for contact and subject burden (Mojo).",[],"['TMQ intervention', 'tailored smoking-cessation intervention delivered 100% through text messaging (TMQ), or (2) non-smoking-related text messages serving as a control for contact and subject burden (Mojo', 'TMQ']",['prolonged abstinence using an intent-to-treat approach'],[],"[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",,0.0817744,"All participants are randomly assigned to receive 12 weeks of either; (1) a tailored smoking-cessation intervention delivered 100% through text messaging (TMQ), or (2) non-smoking-related text messages serving as a control for contact and subject burden (Mojo).","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Deutsch', 'Affiliation': 'Live Inspired LLC, Washington, DC, United States.'}, {'ForeName': 'Beth C', 'Initials': 'BC', 'LastName': 'Bock', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, United States.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lantini', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States. Electronic address: rlantini@lifespan.org.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Walaska', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States.'}, {'ForeName': 'Rochelle K', 'Initials': 'RK', 'LastName': 'Rosen', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States; Department of Behavioral and Social Sciences, School of Public Health of Brown University, Providence, RI, United States.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Fava', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States.'}, {'ForeName': 'Ernestine G', 'Initials': 'EG', 'LastName': 'Jennings', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': 'Live Inspired LLC, Washington, DC, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Flanagan', 'Affiliation': 'Live Inspired LLC, Washington, DC, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.04.010']
3676,32091032,Sustained effects of intralymphatic pollen-specific immunotherapy on Japanese cedar pollinosis.,"BACKGROUND
Intralymphatic immunotherapy (ILIT) for allergic patients requires only a few intralymphatic injections of the allergen. However, the effectiveness and safety for Japanese cedar pollinosis are unclear. The objectives of this study were to clarify whether and how long ILIT is effective for pollinosis, and its safety.
METHODS
In an open pilot investigation followed by a double-blind, placebo-controlled study, patients with Japanese cedar pollinosis received 3 intralymphatic inguinal injections of the pollen extracts before the first pollen season. The symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS) were assessed after the first-third seasons.
RESULTS
(1) Although mild adverse events were induced at the injected site, severe adverse events were not noted. (2) During the latter part of the first season, ILIT-treated patients (n=12) tended to show improved SMS compared to placebo-treated (n=6) without statistical significance. When assessed by nasal provocation testing and VAS scoring after the first season, the effectiveness of ILIT was significant. (3) The effects of ILIT continued until the second or third season. (4) Neither allergen-specific antibodies nor Treg/Breg cells changed in the peripheral blood.
CONCLUSIONS
ILIT was safe and effective for Japanese cedar pollinosis. The clinical effects remained for 1-2 years.",2020,"The symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS) were assessed after the first-third seasons.
","['allergic patients', 'Japanese cedar pollinosis', 'patients with Japanese cedar pollinosis']","['placebo', 'ILIT', 'intralymphatic inguinal injections of the pollen extracts', 'Intralymphatic immunotherapy (ILIT', 'intralymphatic pollen-specific immunotherapy']","['mild adverse events', 'nasal provocation testing and VAS scoring', 'effectiveness and safety', 'severe adverse events', 'symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0996622', 'cui_str': 'Cedar, Japanese'}, {'cui': 'C0018621', 'cui_str': 'Rhinitis, Allergic, Seasonal'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0032385', 'cui_str': 'Pollen Grains'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0449428', 'cui_str': 'Provocation (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",,0.0370664,"The symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS) were assessed after the first-third seasons.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Terada', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Omura', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kikuoka', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Inaka', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Inui', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Matsuda', 'Affiliation': 'Laboratory of Immunopharmacology, Faculty of Pharmaceutical Sciences, Setsunan University, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nabe', 'Affiliation': 'Laboratory of Immunopharmacology, Faculty of Pharmaceutical Sciences, Setsunan University, Osaka, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kawata', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Osaka Medical College, Osaka, Japan.'}]",Rhinology,['10.4193/Rhin19.301']
3677,29860937,Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma.,"BACKGROUND
Cytoreductive nephrectomy has been the standard of care in metastatic renal-cell carcinoma for 20 years, supported by randomized trials and large, retrospective studies. However, the efficacy of targeted therapies has challenged this standard. We assessed the role of nephrectomy in patients with metastatic renal-cell carcinoma who were receiving targeted therapies.
METHODS
In this phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with confirmed metastatic clear-cell renal-cell carcinoma at presentation who were suitable candidates for nephrectomy to undergo nephrectomy and then receive sunitinib (standard therapy) or to receive sunitinib alone. Randomization was stratified according to prognostic risk (intermediate or poor) in the Memorial Sloan Kettering Cancer Center prognostic model. Patients received sunitinib at a dose of 50 mg daily in cycles of 28 days on and 14 days off every 6 weeks. The primary end point was overall survival.
RESULTS
A total of 450 patients were enrolled from September 2009 to September 2017. At this planned interim analysis, the median follow-up was 50.9 months, with 326 deaths observed. The results in the sunitinib-alone group were noninferior to those in the nephrectomy-sunitinib group with regard to overall survival (stratified hazard ratio for death, 0.89; 95% confidence interval, 0.71 to 1.10; upper boundary of the 95% confidence interval for noninferiority, ≤1.20). The median overall survival was 18.4 months in the sunitinib-alone group and 13.9 months in the nephrectomy-sunitinib group. No significant differences in response rate or progression-free survival were observed. Adverse events were as anticipated in each group.
CONCLUSIONS
Sunitinib alone was not inferior to nephrectomy followed by sunitinib in patients with metastatic renal-cell carcinoma who were classified as having intermediate-risk or poor-risk disease. (Funded by Assistance Publique-Hôpitaux de Paris and others; CARMENA ClinicalTrials.gov number, NCT00930033 .).",2018,"The results in the sunitinib-alone group were noninferior to those in the nephrectomy-sunitinib group with regard to overall survival (stratified hazard ratio for death, 0.89; 95% confidence interval, 0.71 to 1.10; upper boundary of the 95% confidence interval for noninferiority, ≤1.20).","['patients with metastatic renal-cell carcinoma who were classified as having intermediate-risk or poor-risk disease', 'Metastatic Renal-Cell Carcinoma', 'patients with metastatic renal-cell carcinoma who were receiving targeted therapies', 'patients with confirmed metastatic clear-cell renal-cell carcinoma at presentation who were suitable candidates for nephrectomy to undergo nephrectomy and then receive sunitinib (standard therapy) or to receive', 'metastatic renal-cell carcinoma for 20 years', '450 patients were enrolled from September 2009 to September 2017']","['nephrectomy', 'Sunitinib Alone or after Nephrectomy', 'Cytoreductive nephrectomy', 'sunitinib', 'sunitinib alone']","['response rate or progression-free survival', 'Adverse events', 'overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}]","[{'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",450.0,0.167799,"The results in the sunitinib-alone group were noninferior to those in the nephrectomy-sunitinib group with regard to overall survival (stratified hazard ratio for death, 0.89; 95% confidence interval, 0.71 to 1.10; upper boundary of the 95% confidence interval for noninferiority, ≤1.20).","[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Méjean', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thezenas', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Colas', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Beauval', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Bensalah', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Lionnel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Cormier', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lang', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Guy', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Gwenaelle', 'Initials': 'G', 'LastName': 'Gravis', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Linassier', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lechevallier', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beisland', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aitchison', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Patard', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Theodore', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Laguerre', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Hubert', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Gross-Goupil', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Bernhard', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Marc-Olivier', 'Initials': 'MO', 'LastName': 'Timsit', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lebret', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': ""From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Descartes, and Paris Descartes Necker-Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and Université de Bordeaux (J.-C.B.), Bordeaux, Biometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Montpellier (S.T.), the Department of Urology, CHU Rangueil (J.-B.B.), and the Department of Medical Oncology, Institut Universitaire du Cancer Toulouse-Oncopole (C.C.), Toulouse, the Department of Urology, University of Rennes (K.B.), and the Department of Medical Oncology, Centre Eugene Marquis (B.L.), Rennes, the Department of Medical Oncology, Institut de Cancerologie de Lorraine, Vandoeuvre lès Nancy (L. Geoffrois), the Department of Medical Oncology, CHU Besançon, Oncologie, and Université de Franche-Comte, INSERM Unité Mixte de Recherche (UMR) 1098, Structure Fédérative de Recherche Ingénierie et Biologie Cellulaire et Tissulaire, Besançon (A.T.-V.), the Department of Urology, CHU François Mitterrand, Dijon (L.C.), the Department of Urology, CHU Strasbourg, Translational Medicine Federation Strasbourg, Strasbourg (H.L.), the Department of Urology, Gabriel Montpied Hospital, and Clermont Auvergne University, Clermont-Ferrand (L. Guy), the Department of Medical Oncology, Centre de Recherche en Cancerologie de Marseille, INSERM UMR 1068, Centre National de la Recherche Scientifique UMR 7258 and Institut Paoli-Calmettes (G.G.), and the Department of Urology, Hôpital la Conception (E.L.), Aix Marseille Université, Marseille, the Department of Medical Oncology, Institut de Cancerologie de l'Ouest, Nantes (F.R.), the Department of Medical Oncology, CHU Bretonneau, and the Department of Medicine, Université François Rabelais, Tours (C.L.), the Department of Urology, Mont de Marsan General Hospital, Mont de Marsan (J.-J.P.), the Departments of Medical Oncology (C.T.) and Urology (T.L.), Hôpital Foch, Suresnes, the Department of Urology, Imagerie Adaptative Diagnostique et Interventionnelle INSERM Unité 1254, CHU de Nancy, Brabois (J.H.), the Department of Medical Oncology, Institut Gustave Roussy and Université Paris-Saclay, Villejuif (L.A., B.E.), and Université Versailles, St.-Quentin-en-Yvelines (T.L.) - all in France; the Department of Urology, Haukeland University Hospital (C.B.), and the Department of Clinical Medicine, University of Bergen (C.B.), Bergen, Norway; and the Department of Urology, Royal Free Hospital, London (M.A.).""}]",The New England journal of medicine,['10.1056/NEJMoa1803675']
3678,30560316,Autonomic Neuromodulation Acutely Ameliorates Left Ventricular Strain in Humans.,"Low-level transcutaneous vagus nerve stimulation at the tragus (LLTS) is anti-adrenergic. We aimed to evaluate the acute effects of LLTS on left ventricular (LV) function and autonomic tone. Patients with diastolic dysfunction and preserved LV ejection fraction were enrolled in a prospective, randomized, double-blind, 2 × 2 cross-over study. Patients received two separate, 1-h sessions, at least 1 day apart, of active LLTS (20 Hz, 1 mA below the discomfort threshold) and sham stimulation. Echocardiography was performed after LLTS or sham stimulation to assess cardiac function. A 5-min ECG was performed to assess heart rate variability (HRV). Twenty-four patients were enrolled. LV global longitudinal strain improved by 1.8 ± 0.9% during active LLTS compared to sham stimulation (p = 0.001). Relative to baseline, HRV frequency domain components (low frequency, high frequency, and their ratio) were favorably altered after LLTS compared to sham stimulation (all p < 0.05). We concluded that LLTS acutely ameliorates cardiac mechanics by modulating the autonomic tone. Trial registration: NCT02983448.",2019,"Relative to baseline, HRV frequency domain components (low frequency, high frequency, and their ratio) were favorably altered after LLTS compared to sham stimulation (all p < 0.05).","['Patients with diastolic dysfunction and preserved LV ejection fraction', 'Twenty-four patients were enrolled', 'Humans']","['LLTS', 'LLTS or sham stimulation', 'Low-level transcutaneous vagus nerve stimulation at the tragus (LLTS', 'active LLTS']","['cardiac mechanics', 'left ventricular (LV) function and autonomic tone', 'HRV frequency domain components (low frequency, high frequency, and their ratio', 'heart rate variability (HRV', 'LV global longitudinal strain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction (finding)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0229312', 'cui_str': 'Tragus structure'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]",24.0,0.269688,"Relative to baseline, HRV frequency domain components (low frequency, high frequency, and their ratio) were favorably altered after LLTS compared to sham stimulation (all p < 0.05).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Asad', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Elkholey', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Scherlag', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Sunny S', 'Initials': 'SS', 'LastName': 'Po', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Stavrakis', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA. stavros-stavrakis@ouhsc.edu.'}]",Journal of cardiovascular translational research,['10.1007/s12265-018-9853-6']
3679,30632410,Combined Atropine with Orthokeratology for Myopia Control: Study Design and Preliminary Results.,"Purpose : The purpose of this study is to present the study design and one month's preliminary results of a 2-year randomized trial, Combined Atropine with Orthokeratology (AOK), for myopia control study. Methods : Children aged 6 to <11 years and with 1.00-4.00 D myopia were randomly assigned to AOK group or ortho-k alone (OK) group. Subjects are required to attend routine ortho-k aftercare visits (first-overnight, 1 week, 2 weeks, 3 weeks, 1 month, and every 3 months after commencement of lens wear). Clinical outcomes, including lens performance, changes in refractive error, unaided vision, ocular adverse events, corneal staining, lens binding and centration, and axial length, are also assessed at 6-monthly data collection visit. Results : Data of 30 AOK and 34 OK subjects who had completed the 1-month visit were analyzed. No significant differences in baseline data were found between the two groups ( P > 0.05). At the 1-month visit, first-fit success rate was 95%, with full myopia reduction. Mild corneal staining was observed in 23.3% and 30.9% and mild self-reported lens binding in 50% and 41% in AOK and OK groups, respectively, after 1-month lens wear. Mean (±standard deviation) change in axial length was significantly higher in AOK than OK subjects (AOK: -0.05 ± 0.05 mm; OK: -0.02 ± 0.03 mm) ( P = 0.003). Conclusions : After 1 month of treatment, first-fit success rate of ortho-k lenses was high in both groups of subjects; addition of 0.01% atropine in AOK subjects did not affect the lens performance or clinical responses. These results provide the assurance that it is acceptable to continue this longitudinal study, as longer study duration, usually 2 years, is required to determine the effectiveness of treatment for myopia control.",2019,"After 1 month of treatment, first-fit success rate of ortho-k lenses was high in both groups of subjects; addition of 0.01% atropine in AOK subjects did not affect the lens performance or clinical responses.","['Methods : Children aged 6 to <11\xa0years and with 1.00-4.00\xa0D myopia', 'Myopia Control', '30 AOK and 34 OK subjects who had completed the 1-month visit were analyzed']","['AOK group or ortho-k alone (OK', 'Atropine', 'Combined Atropine with Orthokeratology (AOK', 'atropine']","['Mean (±standard deviation) change in axial length', 'lens performance, changes in refractive error, unaided vision, ocular adverse events, corneal staining, lens binding and centration, and axial length, are also assessed at 6-monthly data collection visit', 'Mild corneal staining', 'lens performance or clinical responses', 'success rate of ortho-k lenses']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]",,0.0727844,"After 1 month of treatment, first-fit success rate of ortho-k lenses was high in both groups of subjects; addition of 0.01% atropine in AOK subjects did not affect the lens performance or clinical responses.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'a School of Optometry , The Hong Kong Polytechnic University , Hung Hom , Hong Kong.'}, {'ForeName': 'Alex Lk', 'Initials': 'AL', 'LastName': 'Ng', 'Affiliation': 'b Department of Ophthalmology , The University of Hong Kong , Hong Kong.'}, {'ForeName': 'George Pm', 'Initials': 'GP', 'LastName': 'Cheng', 'Affiliation': 'd Hong Kong Laser Eye Centre , Hong Kong.'}, {'ForeName': 'Victor Cp', 'Initials': 'VC', 'LastName': 'Woo', 'Affiliation': 'b Department of Ophthalmology , The University of Hong Kong , Hong Kong.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cho', 'Affiliation': 'a School of Optometry , The Hong Kong Polytechnic University , Hung Hom , Hong Kong.'}]",Current eye research,['10.1080/02713683.2019.1568501']
3680,31390002,Effects of Nicotinamide Riboside on Endocrine Pancreatic Function and Incretin Hormones in Nondiabetic Men With Obesity.,"OBJECTIVE
Augmenting nicotinamide adenine dinucleotide (NAD+) metabolism through dietary provision of NAD+ precursor vitamins translates to improved glucose handling in rodent models of obesity and diabetes. Preclinical evidence suggests that the NAD+/SIRT1 axis may be implicated in modulating important gut-related aspects of glucose regulation. We sought to test whether NAD+ precursor supplementation with nicotinamide riboside (NR) affects β-cell function, α-cell function, and incretin hormone secretion as well as circulating bile acid levels in humans.
DESIGN
A 12-week randomized, double-blind, placebo-controlled, parallel-group trial in 40 males with obesity and insulin resistance allocated to NR at 1000 mg twice daily (n = 20) or placebo (n = 20). Two-hour 75-g oral glucose tolerance tests were performed before and after the intervention, and plasma concentrations of glucose, insulin, C-peptide, glucagon, glucagon-like peptide 1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP) were determined. β-Cell function indices were calculated based on glucose, insulin, and C-peptide measurements. Fasting plasma concentrations of bile acids were determined.
RESULTS
NR supplementation during 12 weeks did not affect fasting or postglucose challenge concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, or GIP, and β-cell function did not respond to the intervention. Additionally, no changes in circulating adipsin or bile acids were observed following NR supplementation.
CONCLUSION
The current study does not provide evidence to support that dietary supplementation with the NAD+ precursor NR serves to impact glucose tolerance, β-cell secretory capacity, α-cell function, and incretin hormone secretion in nondiabetic males with obesity. Moreover, bile acid levels in plasma did not change in response to NR supplementation.",2019,"RESULTS
NR supplementation during 12 weeks neither affected fasting nor post-glucose challenge concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, or GIP, and β-cell function did not respond to the intervention.","['humans', 'obese, non-diabetic males', 'obese, non-diabetic men', '40 obese, insulin-resistant males allocated to NR 1,000 mg twice daily (n = 20) or']","['NAD+ precursor supplementation with nicotinamide riboside (NR', 'placebo', 'nicotinamide riboside']","['glucose, insulin, and C-peptide measurements', 'endocrine pancreatic function and incretin hormones', 'β-cell function indices', 'circulating adipsin or bile acids', 'Fasting plasma concentrations of bile acids', 'plasma concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, and GIP', 'fasting nor post-glucose challenge concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, or GIP, and β-cell function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0068711', 'cui_str': 'pyridinium, 3-(aminocarbonyl)-1-beta-D-ribofuranosyl-'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0232786', 'cui_str': 'Pancreatic function'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0033457', 'cui_str': 'Properdin Factor D'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",40.0,0.138064,"RESULTS
NR supplementation during 12 weeks neither affected fasting nor post-glucose challenge concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, or GIP, and β-cell function did not respond to the intervention.","[{'ForeName': 'Ole L', 'Initials': 'OL', 'LastName': 'Dollerup', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Samuel A J', 'Initials': 'SAJ', 'LastName': 'Trammell', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Gillum', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonas T', 'Initials': 'JT', 'LastName': 'Treebak', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-01081']
3681,31233639,Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis: Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment.,"Sclerostin, a protein produced by osteocytes, inhibits bone formation. Administration of sclerostin antibody results in increased bone formation in multiple animal models. Romosozumab, a humanized sclerostin antibody, has a dual effect on bone, transiently increasing serum biochemical markers of bone formation and decreasing serum markers of bone resorption, leading to increased BMD and reduction in fracture risk in humans. We aimed to evaluate the effects of romosozumab on bone tissue. In a subset of 107 postmenopausal women with osteoporosis in the multicenter, international, randomized, double-blind, placebo-controlled Fracture Study in Postmenopausal Women with Osteoporosis (FRAME), transiliac bone biopsies were performed either after 2 (n = 34) or 12 (n = 73) months of treatment with 210 mg once monthly of romosozumab or placebo to evaluate histomorphometry and microcomputed tomography-based microarchitectural endpoints. After 2 months, compared with either baseline values assessed after a quadruple fluorochrome labeling or placebo, significant increases (P < 0.05 to P < 0.001) in dynamic parameters of formation (median MS/BS: romosozumab 1.51% and 5.64%; placebo 1.60% and 2.31% at baseline and month 2, respectively) were associated with a significant decrease compared with placebo in parameters of resorption in cancellous (median ES/BS: placebo 3.4%, romosozumab 1.8%; P = 0.022) and endocortical (median ES/BS: placebo 6.3%, romosozumab 1.6%; P = 0.003) bone. At 12 months, cancellous bone formation was significantly lower (P < 0.05 to P < 0.001) in romosozumab versus placebo and the lower values for resorption endpoints seen at month 2 persisted (P < 0.001), signaling a decrease in bone turnover (P = 0.006). No significant change was observed in periosteal and endocortical bone. This resulted in an increase in bone mass and trabecular thickness with improved trabecular connectivity, without significant modification of cortical porosity at month 12. In conclusion, romosozumab produced an early and transient increase in bone formation, but a persistent decrease in bone resorption. Antiresorptive action eventually resulted in decreased bone turnover. This effect resulted in significant increases in bone mass and improved microarchitecture. © 2019 American Society for Bone and Mineral Research.",2019,"At 12 months, cancellous bone formation was significantly lower (P < 0.05 to P < 0.001) in romosozumab versus placebo and the lower values for resorption endpoints seen at month 2 persisted (P < 0.001), signaling a decrease in bone turnover (P = 0.006).","['Postmenopausal Women With Osteoporosis', '107 postmenopausal women with osteoporosis', 'Postmenopausal Women with Osteoporosis (FRAME']","['placebo', 'romosozumab', 'sclerostin antibody', 'romosozumab or placebo to evaluate histomorphometry and microcomputed tomography-based microarchitectural endpoints', 'Romosozumab']","['bone resorption', 'bone formation', 'bone mass and trabecular thickness with improved trabecular connectivity', 'bone turnover', 'periosteal and endocortical bone', 'cancellous bone formation', 'bone mass and improved microarchitecture']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661283'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C2350281', 'cui_str': 'Xray Micro-CT'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0442033', 'cui_str': 'Periosteal (qualifier value)'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",,0.273063,"At 12 months, cancellous bone formation was significantly lower (P < 0.05 to P < 0.001) in romosozumab versus placebo and the lower values for resorption endpoints seen at month 2 persisted (P < 0.001), signaling a decrease in bone turnover (P = 0.006).","[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Chavassieux', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Chapurlat', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Portero-Muzy', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Roux', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Garcia', 'Affiliation': 'Endocrinology Service, Osteoporosis Center, University Hospital of Monterrey, Monterrey, Mexico.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Brown', 'Affiliation': 'CHU de Quebec Research Centre and Department of Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Rogely W', 'Initials': 'RW', 'LastName': 'Boyce', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3735']
3682,32088602,Play for success: A novel intervention to boost visual attention in low-socioeconomic-status infants.,"Developmental differences in visual attention between infants of low and high socioeconomic status (SES) have been observed as early as 6 months of age. These deficits in low-SES infants may compound into the well-known achievement gap when children enter grade school. The current study implemented a novel intervention designed to boost early visual attention. The intervention, called Play for Success, was administered through the Early Head Start home visiting program and required all infants to practice focused attention with a caregiver for 10 min a day every day for 2 weeks. A total of 42 6- to 10-month-old infants were randomly assigned to one of three intervention groups: Social (unstructured direction), Teach Two (simple structured direction), or Teach Many (more complex structured direction). Infants' focused attention and inattention were tested three times: before the intervention, immediately following the intervention, and again 4 weeks later. The results demonstrated increased focused attention for both Teach Two and Teach Many. These results suggest that Play for Success is a promising new intervention, but only in the conditions that included parental structured direction.",2020,"Infants' focused attention and inattention were tested three times: before the intervention, immediately following the intervention, and again 4 weeks later.","['infants of low and high socioeconomic status (SES', 'A total of 42 6- to 10-month-old infants', 'low-socioeconomic-status infants']","['novel intervention to boost visual attention', 'Social (unstructured direction), Teach Two (simple structured direction), or Teach Many (more complex structured direction']","['visual attention', 'attention and inattention']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0424101', 'cui_str': 'Inattention (finding)'}]",,0.0222549,"Infants' focused attention and inattention were tested three times: before the intervention, immediately following the intervention, and again 4 weeks later.","[{'ForeName': 'Melissa W', 'Initials': 'MW', 'LastName': 'Clearfield', 'Affiliation': 'Department of Psychology, Whitman College, Walla Walla, WA 99362, USA. Electronic address: clearfmw@whitman.edu.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2020.104810']
3683,31874865,Stress management in obesity during a thermal spa residential programme (ObesiStress): protocol for a randomised controlled trial study.,"INTRODUCTION
Stress and obesity are two public health issues. The relationship between obesity and stress is biological through the actions of stress on the major hormones that regulate appetite (leptin and ghrelin). Many spa resorts in France specialise in the treatment of obesity, but no thermal spa currently proposes a specific programme to manage stress in obesity. The ObesiStress protocol has been designed to offer a new residential stress management programme. This thermal spa treatment of obesity implements stress management strategies as suggested by international recommendations.
METHODS AND ANALYSIS
140 overweight or obese participants with a Body Mass Index of >25 kg/m 2 and aged over 18 years will be recruited. Participants will be randomised into two groups: a control group of usual practice (restrictive diet, physical activity and thermal spa treatment) and an intervention group with stress management in addition to the usual practice. In the present protocol, parameters will be measured on five occasions (at inclusion, at the beginning of the spa (day 0), at the end of the spa (day 21), and at 6 and 12 months). The study will assess the participants' heart rate variability, cardiac remodelling and function, electrodermal activity, blood markers, anthropometric profile, body composition, psychology and quality of life via the use of questionnaires and bone parameters.
ETHICS AND DISSEMINATION
The ObesiStress protocol complies with the ethics guidelines for Clinical Research and has been approved by the ethics committee (CPP Sud-Est VI, Clermont-Ferrand - ANSM: 2016-A01774-47). This study aimed to highlight the efficacy of a 21-day thermal spa residential programme of stress management in obesity through objective measurements of well-being and cardiovascular morbidity. Results will be disseminated during several research conferences and articles published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT03578757.",2019,"The study will assess the participants' heart rate variability, cardiac remodelling and function, electrodermal activity, blood markers, anthropometric profile, body composition, psychology and quality of life via the use of questionnaires and bone parameters.
",['140 overweight or obese participants with a Body Mass Index of >25\u2009kg/m 2 and aged over 18 years will be recruited'],"['control group of usual practice (restrictive diet, physical activity and thermal spa treatment) and an intervention group with stress management in addition to the usual practice']","['heart rate variability, cardiac remodelling and function, electrodermal activity, blood markers, anthropometric profile, body composition, psychology and quality of life via the use of questionnaires and bone parameters']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0034380'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",140.0,0.0571177,"The study will assess the participants' heart rate variability, cardiac remodelling and function, electrodermal activity, blood markers, anthropometric profile, body composition, psychology and quality of life via the use of questionnaires and bone parameters.
","[{'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Preventive and Occupational Medicine, WittyFit, Clermont-Ferrand, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Chaplais', 'Affiliation': 'Université de Lorraine, Laboratory ""Development, Adaption and Disability"" (DevAH - EA 3450), Nancy, France elodie.chaplais@acu.edu.au.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Vilmant', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Preventive and Occupational Medicine, WittyFit, Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Courteix', 'Affiliation': 'Université Clermont Auvergne, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P - EA 3533), Clermont-Ferrand, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Duche', 'Affiliation': 'Université de Toulon, Laboratory of Impact of Physical Activity on Health (IAPS), Toulon, France.'}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Abergel', 'Affiliation': 'Université Clermont Auvergne, CNRS, UMR 6284, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Hepatology Gastroenterology, Clermont-Ferrand, France.'}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Pfabigan', 'Affiliation': 'School of Psychological and Cognitive Sciences, PKU-IDG/McGovern Institute for Brain Research, Beijing Key Laboratory of Behavior and Mental Health, Peking University, Beijing, China.'}, {'ForeName': 'Shihui', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'School of Psychological and Cognitive Sciences, PKU-IDG/McGovern Institute for Brain Research, Beijing Key Laboratory of Behavior and Mental Health, Peking University, Beijing, China.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Mobdillon', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, Clermont-Ferrand, France.'}, {'ForeName': 'Guillaume T', 'Initials': 'GT', 'LastName': 'Vallet', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, Clermont-Ferrand, France.'}, {'ForeName': 'Martial', 'Initials': 'M', 'LastName': 'Mermillod', 'Affiliation': 'Université Grenoble Alpes, Université Savoie Mont Blanc, LPNC, CNRS, Grenoble, France.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Boudet', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Preventive and Occupational Medicine, WittyFit, Clermont-Ferrand, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Obert', 'Affiliation': ""Université d'Avignon, Laboratory of Cardiovascular Pharm-ecology (LaPEC EA4278), Avignon, France.""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Izem', 'Affiliation': ""Université d'Avignon, Laboratory of Cardiovascular Pharm-ecology (LaPEC EA4278), Avignon, France.""}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Miolanne-Debouit', 'Affiliation': 'University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Unit of Human Nutrition, Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Farigon', 'Affiliation': 'University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Unit of Human Nutrition, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Biostatistics Unit, Clinical research and Innovation Department (DRCI), Biostatistics, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Université Clermont Auvergne, INRA, CRNH, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Unit of Human Nutrition, Clermont-Ferrand, France.'}]",BMJ open,['10.1136/bmjopen-2018-027058']
3684,31874872,Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol.,"INTRODUCTION
Despite the enormous potential for adverse events in primary healthcare (PHC), the knowledge about how to improve patient safety in this context is still sparse. We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.
METHODS AND ANALYSIS
The intervention will consist in using the patient reported experiences and outcomes of safety in primary care (PREOS-PC) survey to gather patient-reported experiences and outcomes concerning the safety of the healthcare patients receive in their PHC centres, and feed that information back to the PHC professionals to help them identify opportunities for safer healthcare provision. The study will involve three stages. Stage 1 (developing the intervention) will involve: (i) qualitative study with 40 PHC providers to optimise the acceptability and perceived utility of the proposed intervention; (ii) Spanish translation, cross-cultural adaptation and validation of the PREOS-PC survey; (iii) developing the intervention components; and (iv) developing an online tool to electronically administrate PREOS-PC and automatically generate feedback reports to PHC centres. Stage 2 (piloting the intervention) will involve a 3-month feasibility (one group pre-post) study in 10 PHC centres (500 patients, 260 providers). Stage 3 (evaluating the intervention) will involve: (i) a 12-month, two-arm, two-level cluster randomised controlled trial (1248 PHC professionals within 48 PHC centres; with randomisation at the centre level in a 1:1 ratio) to evaluate the impact of the intervention on patient safety culture (primary outcome), patient-reported safety experiences and outcomes (using the PREOS-PC survey), and avoidable hospitalisations; (ii) qualitative study with 20 PHC providers to evaluate the acceptability and perceived utility of the intervention and identify implementation barriers.
ETHICS AND DISSEMINATION
The study was approved by the Ethics Committee of the Balearic Islands (CEI IB: 3686/18) with the 1964 Helsinki Declaration and its later amendments. The results will be disseminated in peer-reviewed publications and national and international conferences.
TRIAL REGISTRATION NUMBER
NCT03837912; pre-results.",2019,"We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.
","['primary healthcare (PHC', 'Spanish primary healthcare centres', 'Spanish PHC centres']",[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],[],500.0,0.0611907,"We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.
","[{'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Serrano-Ripoll', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Ripoll', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Llobera', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Valderas', 'Affiliation': 'Health Services and Policy Research, Medical School, University of Exeter, Exeter, Devon, UK.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Pastor-Moreno', 'Affiliation': 'CIBER Epidemiology and Public Health. CIBERESP, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Olry de Labry Lima', 'Affiliation': 'CIBER Epidemiology and Public Health. CIBERESP, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Ricci-Cabello', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain ignacio.ricci@ssib.es.'}]",BMJ open,['10.1136/bmjopen-2019-031367']
3685,31354946,The effects of auditory spatial training on informational masking release in elderly listeners: a study protocol for a randomized clinical trial.,"Background: Regarding the strong auditory spatial plasticity capability of the central auditory system and the effect of short-term and long-term rehabilitation programs in elderly people, it seems that an auditory spatial training can help this population in informational masking release and better track speech in noisy environments. The main purposes of this study are developing an informational masking measurement test and an auditory spatial training program. Protocol: This study will be conducted in two parts. Part 1: develop and determine the validity of an informational masking measurement test by recruiting two groups of young (n=50) and old (n=50) participants with normal hearing who have no difficulty in understanding speech in noisy environments. Part 2 (clinical trial): two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments, will participate as control and intervention groups to examine the effect of auditory spatial training. Intervention: 15 sessions of auditory spatial training. The informational masking measurement test and Speech, Spatial and Qualities of Hearing Scale will be compared before intervention, immediately after intervention, and five weeks after intervention between the two groups. Discussion: Since auditory training programs do not deal with informational masking release, an auditory spatial training will be designed, aiming to improve hearing in noisy environments for elderly populations. Trial registration: Iranian Registry of Clinical Trials ( IRCT20190118042404N1) on 25 th February 2019.",2019,"two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments, will participate as control and intervention groups to examine the effect of auditory spatial training.","['two groups of young (n=50) and old (n=50) participants with normal hearing who have no difficulty in understanding speech in noisy environments', '25 th February 2019', 'two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments', 'elderly listeners', 'elderly people']","['short-term and long-term rehabilitation programs', 'auditory spatial training']","['informational masking measurement test and Speech, Spatial and Qualities of Hearing Scale', 'informational masking release']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0563025', 'cui_str': 'Noisy environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0222045'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",,0.0363944,"two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments, will participate as control and intervention groups to examine the effect of auditory spatial training.","[{'ForeName': 'Farnoush', 'Initials': 'F', 'LastName': 'Jarollahi', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Jalaie', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Jalal', 'Initials': 'SJ', 'LastName': 'Sameni', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}]",F1000Research,['10.12688/f1000research.18602.2']
3686,32061718,Characteristics of Chinese fish-allergic patients: Findings from double-blind placebo-controlled food challenges.,,2020,,['Chinese fish-allergic patients'],['placebo'],[],"[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.3927,,"[{'ForeName': 'Agnes Sze Yin', 'Initials': 'ASY', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Nicki Yat Hin', 'Initials': 'NYH', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Christine Yee Yan', 'Initials': 'CYY', 'LastName': 'Wai', 'Affiliation': 'Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kary Jia Ying', 'Initials': 'KJY', 'LastName': 'Xu', 'Affiliation': 'Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Maco Cheuk Yin', 'Initials': 'MCY', 'LastName': 'Lam', 'Affiliation': 'Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yuki Yuk', 'Initials': 'YY', 'LastName': 'Shum', 'Affiliation': 'Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tak Hong', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Allergy Centre, Hong Kong Sanatorium and Hospital, Hong Kong.'}, {'ForeName': 'Marco Hok Kung', 'Initials': 'MHK', 'LastName': 'Ho', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sou Da Rosa Duque', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Gilbert T', 'Initials': 'GT', 'LastName': 'Chua', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Yat Sun', 'Initials': 'YS', 'LastName': 'Yau', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Wai Hung', 'Initials': 'WH', 'LastName': 'Chan', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Po Ki', 'Initials': 'PK', 'LastName': 'Ho', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Gary Wing Kin', 'Initials': 'GWK', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ting Fan', 'Initials': 'TF', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong. Electronic address: tfleung@cuhk.edu.hk.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.02.002']
3687,32043762,Oral Care Evaluation to Prevent Oral Mucositis in Estrogen Receptor-Positive Metastatic Breast Cancer Patients Treated with Everolimus (Oral Care-BC): A Randomized Controlled Phase III Trial.,"BACKGROUND
The incidence of oral mucositis (any grade) after everolimus treatment is 58% in the general population and 81% in Asian patients. This study hypothesized that professional oral care (POC) before everolimus treatment could reduce the incidence of everolimus-induced oral mucositis.
MATERIALS AND METHODS
This randomized, multicenter, open-label, phase III study evaluated the efficacy of POC in preventing everolimus-induced mucositis. Patients were randomized into POC and control groups (1:1 ratio) and received everolimus with exemestane. Patients in the POC group underwent teeth surface cleaning, scaling, and tongue cleaning before everolimus initiation and continued to receive weekly POC throughout the 8-week treatment period. Patients in the control group brushed their own teeth and gargled with 0.9% sodium chloride solution or water. The primary endpoint was the incidence of all grades of oral mucositis. We targeted acquisition of 200 patients with a 2-sided type I error rate of 5% and 80% power to detect 25% risk reduction.
RESULTS
Between March 2015 and December 2017, we enrolled 175 women from 31 institutions, of which five did not receive the protocol treatment and were excluded. Over the 8 weeks, the incidence of grade 1 oral mucositis was significantly different between the POC group (76.5%, 62 of 82 patients) and control group (89.7%, 78 of 87 patients; p = .034). The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients; p = .015). As a result of oral mucositis, 18 (22.0%) patients in the POC group and 28 (32.2%) in the control group had to undergo everolimus dose reduction.
CONCLUSION
POC reduced the incidence and severity of oral mucositis in patients receiving everolimus and exemestane. This might be considered as a treatment option of oral care for patients undergoing this treatment. Clinical trial identification number: NCT02069093.
IMPLICATIONS FOR PRACTICE
The Oral Care-BC trial that prophylactically used professional oral care (POC), available worldwide, did not show a greater than 25% difference in mucositis. The 12% difference in grade 1 or higher mucositis and especially the ∼20% difference in grade 2 mucositis are likely clinically meaningful to patients. POC before treatment should be considered as a treatment option of oral care for postmenopausal patients who are receiving everolimus and exemestane for treatment of hormone receptor-positive, HER2-negative advanced breast cancer and metastatic breast cancer. However, POC was not adequate for prophylactic oral mucositis in these patients, and dexamethasone mouthwash prophylaxis is standard treatment before everolimus.",2020,"The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients; p = .015).","['175 women from 31 institutions, of which five did not receive the protocol treatment and were excluded', '200 patients with a 2-sided type I error rate of 5% and 80% power to detect 25% risk reduction', 'Between March 2015 and December 2017', 'for treatment of hormone receptor-positive, HER2-negative advanced breast cancer and metastatic breast cancer', 'postmenopausal patients who are receiving', 'Estrogen Receptor-Positive Metastatic Breast Cancer Patients', 'patients undergoing this treatment', 'general population and 81% in Asian patients']","['Oral Care Evaluation', 'sodium chloride solution or water', 'Everolimus (Oral Care-BC', 'everolimus with exemestane', 'everolimus and exemestane']","['incidence and severity of oral mucositis', 'incidence of everolimus-induced oral mucositis', 'mucositis', 'grade 1 or higher mucositis', 'incidence of grade 1 oral mucositis', 'Oral Mucositis', 'prophylactic oral mucositis', 'grade 2 mucositis', 'incidence of all grades of oral mucositis', 'incidence of grade 2 (severe) oral mucositis', 'oral mucositis']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0078988', 'cui_str': 'Asians'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]",175.0,0.029655,"The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients; p = .015).","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Niikura', 'Affiliation': 'Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Nakatukasa', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Amemiya', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Watanabe', 'Affiliation': 'Department of Breast Surgery, Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Department of Dentistry, Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kikawa', 'Affiliation': 'Department of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Taniike', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Sachiyo', 'Initials': 'S', 'LastName': 'Mitsunaga', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagami', 'Affiliation': 'Department of Breast and Endocrine Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Moriyasu', 'Initials': 'M', 'LastName': 'Adachi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Department of Breast and Endocrine Surgery, Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shibuya', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': ""Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Naito', 'Affiliation': 'Department of Oral Epidemiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kashiwabara', 'Affiliation': 'Department of Biostatistics, School of Public Health, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Umeda', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Ota', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Tokai University School of Medicine, Tokyo, Japan.'}]",The oncologist,['10.1634/theoncologist.2019-0382']
3688,31373648,Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia: The Phase 2 RAINSTORM Randomized Clinical Trial.,"Importance
Ramucirumab, a human IgG 1 antibody against vascular endothelial growth factor receptor 2, has been shown to improve progression-free survival and overall survival in patients with advanced gastric cancer in the second-line setting.
Objective
To compare progression-free survival for S-1 and oxaliplatin plus ramucirumab with that for S-1 and oxaliplatin plus placebo in patients with advanced gastric cancer.
Design, Setting, and Participants
This phase 2, double-blind randomized clinical trial (RAINSTORM [First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab in Patients With Advanced Gastric Cancer]) was conducted from October 12, 2015, to April 11, 2018, at 36 sites in Japan, South Korea, and Taiwan. Participants were chemotherapy-naive patients (n = 189) with metastatic gastric or gastroesophageal adenocarcinoma. Analyses of the full analysis set and safety population were conducted between November 27, 2017, and June 4, 2018.
Interventions
Patients randomized to the ramucirumab plus S-1 and oxaliplatin arm received S-1, 80 to 120 mg/d twice daily, on days 1 to 14 and oxaliplatin, 100 mg/m2, on day 1 with ramucirumab, 8 mg/kg, on days 1 and 8 in part A (21-day cycle). Patients randomized to the placebo plus S-1 and oxaliplatin arm received the same S-1 and oxaliplatin dosage as well as placebo on days 1 and 8 in part A. Eligible patients received second-line paclitaxel, 80 mg/m2, on days 1, 8, and 15 and ramucirumab, 8 mg/kg, on days 1 and 15 in part B (28-day cycle).
Main Outcomes and Measures
The primary end point was progression-free survival, analyzed using the stratified log-rank test; the hazard ratio (HR) was estimated using the stratified Cox proportional hazards regression model. Secondary end points included overall survival and adverse events.
Results
In total, 189 patients were randomized and received treatment: 96 to the ramucirumab plus S-1 and oxaliplatin arm and 93 to the placebo plus S-1 and oxaliplatin arm. Among the 189 patients, 121 (64.0%) were male, and the median (range) age was 62.0 (26-84) years. Median progression-free survival was not prolonged in the ramucirumab plus S-1 and oxaliplatin arm compared with the placebo plus S-1 and oxaliplatin arm (6.34 [80% CI, 5.65-6.93] vs 6.74 [80% CI, 5.75-7.13] months; HR, 1.07; 80% CI, 0.86-1.33; P = .70). Median overall survival was 14.65 (80% CI, 12.39-15.67) months in the ramucirumab plus S-1 and oxaliplatin arm and 14.26 (80% CI, 13.83-17.31) months in the placebo plus S-1 and oxaliplatin arm (HR, 1.11; 80% CI, 0.89-1.40; P = .55). The most commonly reported grade 3 or higher treatment-emergent adverse events in the ramucirumab plus S-1 and oxaliplatin arm in part A were decreased neutrophil count (14 patients [14.6%]), hypertension (10 patients [10.4%]), and anemia (10 patients [10.4%]).
Conclusions and Relevance
In this randomized clinical trial, the addition of ramucirumab to first-line S-1 and oxaliplatin treatment did not prolong progression-free survival or overall survival compared with S-1 and oxaliplatin alone among East Asian patients with advanced gastric cancer; no new safety signals for ramucirumab were identified.
Trial Registration
ClinicalTrials.gov identifier: NCT02539225.",2019,"Median progression-free survival was not prolonged in the ramucirumab plus S-1 and oxaliplatin arm compared with the placebo plus S-1 and oxaliplatin arm (6.34 [80% CI, 5.65-6.93] vs 6.74 [80% CI, 5.75-7.13] months; HR, 1.07; 80% CI, 0.86-1.33; P = .70).","['189 patients, 121 (64.0%) were male, and the median (range) age was 62.0 (26-84) years', '189 patients', 'patients with advanced gastric cancer in the second-line setting', 'East Asian patients with advanced gastric cancer', 'Advanced Gastric Cancer in East Asia', 'Participants were chemotherapy-naive patients (n\u2009=\u2009189) with metastatic gastric or gastroesophageal adenocarcinoma', 'Patients With Advanced Gastric Cancer]) was conducted from October 12, 2015, to April 11, 2018, at 36 sites in Japan, South Korea, and Taiwan', 'patients with advanced gastric cancer']","['S-1 and oxaliplatin', 'First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab', 'Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab', 'S-1 and oxaliplatin plus ramucirumab', 'placebo', 'ramucirumab to first-line S-1 and oxaliplatin', 'second-line paclitaxel', 'ramucirumab plus S-1 and oxaliplatin', 'S-1 and oxaliplatin plus placebo', 'oxaliplatin', 'placebo plus S-1 and oxaliplatin', 'S-1 and oxaliplatin alone']","['progression-free survival or overall survival', 'overall survival and adverse events', 'progression-free survival', 'hazard ratio (HR', 'Median overall survival', 'hypertension', 'Median progression-free survival', 'progression-free survival and overall survival', 'neutrophil count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0015631', 'cui_str': 'East Asia'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",189.0,0.425559,"Median progression-free survival was not prolonged in the ramucirumab plus S-1 and oxaliplatin arm compared with the placebo plus S-1 and oxaliplatin arm (6.34 [80% CI, 5.65-6.93] vs 6.74 [80% CI, 5.75-7.13] months; HR, 1.07; 80% CI, 0.86-1.33; P = .70).","[{'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Kudo', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'The Cancer Institute Hospital of the Japanese Foundation of Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Graduate School of Medicine, Gifu University, Gifu, Japan.'}, {'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Omuro', 'Affiliation': 'Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Li-Yuan', 'Initials': 'LY', 'LastName': 'Bai', 'Affiliation': 'Division of Hematology and Oncology, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Kaijiro', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Eli Lilly Japan KK, Kobe, Japan.'}, {'ForeName': 'Akichika', 'Initials': 'A', 'LastName': 'Ozeki', 'Affiliation': 'Eli Lilly Japan KK, Kobe, Japan.'}, {'ForeName': 'Reigetsu', 'Initials': 'R', 'LastName': 'Yoshikawa', 'Affiliation': 'Eli Lilly Japan KK, Kobe, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8243']
3689,31378980,Nutrient supplementation during the first 1000 days and growth of infants born to pregnant adolescents.,"Few studies have evaluated the impact of nutritional supplementation among pregnant adolescents. We examined the effects of the Rang Din Nutrition Study (RDNS) interventions on children born to mothers <20 years of age. The RDNS was a cluster-randomized effectiveness trial with four arms: (1) women and children both received small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control). We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents. Among adolescents, prenatal LNS reduced newborn stunting by 25% and small head size by 28% and had a marginally significant effect on newborn wasting, compared with IFA. Low birth weight and preterm birth were reduced only among adolescents with lower food security. Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control). Initiatives targeting pregnant adolescents in similar settings should consider inclusion of small-quantity LNS, particularly for adolescents living in food-insecure households.",2020,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"['adolescents living in food-insecure households', 'We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents', 'children born to mothers <20 years of age', 'infants born to pregnant adolescents', 'pregnant adolescents']","['Rang Din Nutrition Study (RDNS) interventions', 'Nutrient supplementation', 'small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control']","['Low birth weight and preterm birth', 'subsequent growth status', 'newborn wasting', 'newborn stunting']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}]",1552.0,0.0901711,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"[{'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}]",Annals of the New York Academy of Sciences,['10.1111/nyas.14191']
3690,31257404,Markers of kidney tubule function and risk of cardiovascular disease events and mortality in the SPRINT trial.,"AIMS
Biomarkers of kidney tubule injury, inflammation and fibrosis have been studied extensively and established as risk markers of adverse kidney and cardiovascular disease (CVD) outcomes. However, associations of markers of kidney tubular function with adverse clinical events have not been well studied, especially in persons with chronic kidney disease (CKD).
METHODS AND RESULTS
Using a sample of 2377 persons with CKD at the baseline Systolic Blood Pressure Intervention Trial (SPRINT) visit, we evaluated the association of three urine tubular function markers, alpha-1 microglobulin (α1m), beta-2 microglobulin (β2m), and uromodulin, with a composite CVD endpoint (myocardial infarction, acute coronary syndrome, stroke, acute decompensated heart failure, or death from cardiovascular causes) and mortality using Cox proportional hazards regression, adjusted for baseline estimated glomerular filtration rate (eGFR), albuminuria, and CVD risk factors. In unadjusted analysis, over a median follow-up of 3.8 years, α1m and β2m had positive associations with composite CVD events and mortality, whereas uromodulin had an inverse association with risk for both outcomes. In multivariable analysis including eGFR and albuminuria, a two-fold higher baseline concentration of α1m was associated with higher risk of CVD [hazard ratio (HR) 1.25; 95% confidence interval (CI): 1.10-1.45] and mortality (HR 1.25; 95% CI: 1.10-1.46), whereas β2m had no association with either outcome. A two-fold higher uromodulin concentration was associated with lower CVD risk (HR 0.79; 95% CI: 0.68-0.90) but not mortality (HR 0.86; 95% CI: 0.73-1.01) after adjusting for similar confounders.
CONCLUSION
Among non-diabetic persons with CKD, biomarkers of tubular function are associated with CVD events and mortality independent of glomerular function and albuminuria.",2019,"A two-fold higher uromodulin concentration was associated with lower CVD risk (HR 0.79; 95% CI: 0.68-0.90) but not mortality (HR 0.86; 95% CI: 0.73-1.01) after adjusting for similar confounders.
","['persons with chronic kidney disease (CKD', '2377 persons with CKD at the baseline Systolic Blood Pressure Intervention Trial (SPRINT) visit']",[],"['uromodulin concentration', 'urine tubular function markers, alpha-1 microglobulin (α1m), beta-2 microglobulin (β2m), and uromodulin, with a composite CVD endpoint (myocardial infarction, acute coronary syndrome, stroke, acute decompensated heart failure, or death from cardiovascular causes) and mortality', 'CVD risk', 'mortality', 'glomerular filtration rate (eGFR), albuminuria, and CVD risk factors']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}]",[],"[{'cui': 'C0077918', 'cui_str': 'Uromucoid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042037'}, {'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2939113', 'cui_str': 'Alpha 1 microglobulin'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",2377.0,0.134329,"A two-fold higher uromodulin concentration was associated with lower CVD risk (HR 0.79; 95% CI: 0.68-0.90) but not mortality (HR 0.86; 95% CI: 0.73-1.01) after adjusting for similar confounders.
","[{'ForeName': 'Pranav S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Lee', 'Affiliation': 'Division of General Internal Medicine, San Francisco VA Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Udayan', 'Initials': 'U', 'LastName': 'Bhatt', 'Affiliation': 'Division of Nephrology, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Internal Medicine, Medical Service, University of Utah, Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Medicine, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craven', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Amret T', 'Initials': 'AT', 'LastName': 'Hawfield', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Kidney Health Research Collaborative, San Francisco VA Medical Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Carrollton, TX, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Wall', 'Affiliation': 'Division of Nephrology, University of Tennessee, Memphis, TN, USA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Division of General Internal Medicine, San Francisco VA Medical Center, San Francisco, CA, USA.'}]",European heart journal,['10.1093/eurheartj/ehz392']
3691,32086657,Comparing Fidelity Outcomes of Paraprofessional and Professional Delivery of a Perinatal Depression Preventive Intervention.,"Mothers and Babies (MB), a perinatal depression preventive intervention, has proven effective in decreasing depressive symptoms and preventing onset of major depression. An ongoing cluster-randomized trial is comparing the effectiveness of the six-session MB group intervention led by paraprofessionals versus mental health professionals. Twenty percent of all audio-recorded intervention sessions were randomly selected for fidelity checks. Analyses assessed mean facilitator adherence and competency overall, by study arm, and by session; and, examined site, facilitator, and client-specific effects. There were no significant differences found between study arms. Findings show paraprofessionals can deliver MB with similar fidelity as mental health professionals.",2020,"Mothers and Babies (MB), a perinatal depression preventive intervention, has proven effective in decreasing depressive symptoms and preventing onset of major depression.",['Mothers and Babies (MB'],['Paraprofessional and Professional Delivery of a Perinatal Depression Preventive Intervention'],"['mean facilitator adherence and competency overall, by study arm, and by session; and, examined site, facilitator, and client-specific effects']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0355021,"Mothers and Babies (MB), a perinatal depression preventive intervention, has proven effective in decreasing depressive symptoms and preventing onset of major depression.","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Diebold', 'Affiliation': 'Institute for Public Health and Medicine, Center for Community Health, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, Suite 643, Chicago, IL, 60611, USA. alicia.diebold@northwestern.edu.'}, {'ForeName': 'Jody D', 'Initials': 'JD', 'LastName': 'Ciolino', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, USA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Institute for Public Health and Medicine, Center for Community Health, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, Suite 643, Chicago, IL, 60611, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yeh', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, USA.'}, {'ForeName': 'Jackie K', 'Initials': 'JK', 'LastName': 'Gollan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, USA.'}, {'ForeName': 'S Darius', 'Initials': 'SD', 'LastName': 'Tandon', 'Affiliation': 'Department of Medical Social Sciences, Institute for Public Health and Medicine, Center for Community Health, Feinberg School of Medicine, Northwestern University, Chicago, USA.'}]",Administration and policy in mental health,['10.1007/s10488-020-01022-5']
3692,32069120,Combination of head-up sleep and vertical recognition training may cure intractable motion-evoked dizziness with unknown origin.,"Background: It has been reported that head-up sleep (HUS) prevents free-floating otoliths from entering canals and that vertical recognition training (VRT) promotes vestibular compensation. Aims/objectives: We would like to assess HUS and VRT for intractable motion-evoked dizziness, including possible benign paroxysmal positional vertigo (BPPV). Materials and methods: 162 patients diagnosed with intractable motion-evoked dizziness of unknown origin were enrolled and randomly divided into the following four groups: HUS-/VRT-, HUS+/VRT-, HUS-/VRT+, and HUS+/VRT+. The at-home interventions comprised HUS with an upper head position of 45° when lying down and VRT with a right down-left down 30° head inclination while watching the vertical index. Results: At the post-treatment 6th month, visual analogue scale (VAS) scores for vertiginous sensation were significantly lower in the HUS+/VRT + group than in the HUS+/VRT - and HUS-/VRT + groups, which were in turn significantly lower than those in the HUS-/VRT - group. VAS scores in the HUS-/VRT + group of patients with abnormal subjective visual vertical (SVV) were significantly lower than those in the HUS+/VRT - group, while those in the HUS+/VRT - group of patients with normal SVV were significantly lower than those in the HUS-/VRT + group. Conclusions: HUS and/or VRT is a good initial treatment for patients with intractable undiagnosed motion-evoked dizziness, including possible BPPV.",2020,"and/or VRT is a good initial treatment for patients with intractable undiagnosed motion-evoked dizziness, including possible BPPV.","['162 patients diagnosed with intractable motion-evoked dizziness of unknown origin', 'patients with intractable undiagnosed motion-evoked dizziness']","['HUS and VRT', 'head-up sleep and vertical recognition training', 'HUS', 'HUS with an upper head position of 45° when lying down and VRT with a right down-left down 30° head inclination while watching the vertical index', 'VRT', 'HUS-/VRT-, HUS+/VRT-, HUS-/VRT+, and HUS+/VRT']","['VAS scores', 'visual analogue scale (VAS) scores for vertiginous sensation', 'abnormal subjective visual vertical (SVV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}]","[{'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0582540', 'cui_str': 'Head positions'}, {'cui': 'C0560843', 'cui_str': 'Does lie down (finding)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}]",162.0,0.0136908,"and/or VRT is a good initial treatment for patients with intractable undiagnosed motion-evoked dizziness, including possible BPPV.","[{'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kitahara', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara-City, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Horinaka', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara-City, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Shiozaki', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara-City, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara-City, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara-City, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara-City, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nario', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara-City, Japan.'}]",Acta oto-laryngologica,['10.1080/00016489.2020.1727566']
3693,30521757,Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial.,"Rationale: Primary treatment of obstructive sleep apnea can be accompanied by a persistence of excessive sleepiness despite adherence. Furthermore, effectiveness of sleep apnea treatment is limited by poor adherence. Currently available pharmacologic options for the treatment of sleepiness in this population are limited. Objectives: To evaluate the efficacy and safety of solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects, for the treatment of excessive sleepiness in participants with obstructive sleep apnea with current or prior sleep apnea treatment. Methods: This was a double-blind, randomized, placebo-controlled, parallel-group, 12-week trial comparing solriamfetol, 37.5, 75, 150, and 300 mg, with placebo. Measurements and Main Results: Of 476 randomized participants, 459 were included in the prespecified efficacy analyses. Coprimary endpoints (Maintenance of Wakefulness Test sleep latency and Epworth Sleepiness Scale score) were met at all solriamfetol doses ( P < 0.05), with dose-dependent effects observed at Week 1 maintained over the study duration. All doses except 37.5 mg resulted in higher percentages of participants reporting improvement on Patient Global Impression of Change (key secondary endpoint; P < 0.05). Adverse events were reported in 47.9% of placebo- and 67.9% of solriamfetol-treated participants; five participants experienced serious adverse events (two [1.7%] placebo, three [0.8%] solriamfetol); none were deemed related to study drug. The most common adverse events with solriamfetol were headache (10.1%), nausea (7.9%), decreased appetite (7.6%), anxiety (7.0%), and nasopharyngitis (5.1%). Conclusions: Solriamfetol significantly increased wakefulness and reduced sleepiness in participants with obstructive sleep apnea and excessive sleepiness; most adverse events were mild or moderate in severity. Clinical trial registered with www.clinicaltrials.gov (NCT02348606) and www.eudract.ema.europa.eu (EudraCT 2014-005514-31).",2019,All doses except 37.5 mg resulted in higher percentages of participants reporting improvement on Patient Global Impression of Change (key secondary endpoint; P < 0.05).,"['participants with obstructive sleep apnea and excessive sleepiness', 'participants with obstructive sleep apnea with current or prior sleep apnea treatment', '476 randomized participants, 459 were included in the prespecified efficacy analyses']","['Solriamfetol', 'placebo', 'solriamfetol (JZP-110']","['decreased appetite', 'Adverse events', 'nasopharyngitis', 'nausea', 'adverse events', 'headache', 'Patient Global Impression of Change', 'obstructive sleep apnea', 'anxiety', 'wakefulness and reduced sleepiness', 'serious adverse events', 'Coprimary endpoints (Maintenance of Wakefulness Test sleep latency and Epworth Sleepiness Scale score']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4547387', 'cui_str': 'JZP-110'}]","[{'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}]",476.0,0.103396,All doses except 37.5 mg resulted in higher percentages of participants reporting improvement on Patient Global Impression of Change (key secondary endpoint; P < 0.05).,"[{'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Schweitzer', 'Affiliation': ""1 Sleep Medicine and Research Center, St. Luke's Hospital, Chesterfield, Missouri.""}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': '2 NeuroTrials Research, Atlanta, Georgia.'}, {'ForeName': 'Gary K', 'Initials': 'GK', 'LastName': 'Zammit', 'Affiliation': '4 Clinilabs Drug Development Corporation, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gotfried', 'Affiliation': '6 Pulmonary Associates, PA, Phoenix, Arizona.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': '7 Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Carter', 'Affiliation': '7 Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': '7 Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': '7 Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': '7 Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': '10 University of California, San Diego, San Diego, California; and.'}, {'ForeName': 'Kingman P', 'Initials': 'KP', 'LastName': 'Strohl', 'Affiliation': '11 Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201806-1100OC']
3694,32078815,"Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).","BACKGROUND
Current efficacy studies of a mosaic HIV-1 prophylactic vaccine require four vaccination visits over one year, which is a complex regimen that could prove challenging for vaccine delivery at the community level, both for recipients and clinics. In this study, we evaluated the safety, tolerability, and immunogenicity of shorter, simpler regimens of trivalent Ad26.Mos.HIV expressing mosaic HIV-1 Env/Gag/Pol antigens combined with aluminium phosphate-adjuvanted clade C gp140 protein.
METHODS
We did this randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deaconess Medical Center in Boston, MA, USA. We included healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement. We randomly assigned participants via a computer-generated randomisation schedule and interactive web response system to one of three study groups (1:1:1) testing different regimens of trivalent Ad26.Mos.HIV (5 × 10 10 viral particles per 0·5 mL) combined with 250 μg adjuvanted clade C gp140 protein. They were then assigned to treatment or placebo subgroups (5:1) within each of the three main groups. Participants and investigators were masked to treatment allocation until the end of the follow-up period. Group 1 received Ad26.Mos.HIV alone at weeks 0 and 12 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 24 and 48. Group 2 received Ad26.Mos.HIV plus adjuvanted gp140 at weeks 0, 12, and 24. Group 3 received Ad26.Mos.HIV alone at week 0 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 8 and 24. Participants in the control group received 0·5 mL of 0·9% saline. All study interventions were administered intramuscularly. The primary endpoints were Env-specific binding antibody responses at weeks 28, 52, and 72 and safety and tolerability of the vaccine regimens for 28 days after the injection. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. The IPCAVD010/HPX1002 trial is registered with ClinicalTrials.gov, NCT02685020. We also did a parallel preclinical study in rhesus monkeys to test the protective efficacy of the shortened group 3 regimen.
FINDINGS
Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study vaccine or placebo, ten to each vaccine group and two to the corresponding placebo group. 30 (83%) participants completed the full study, and six (17%) discontinued it prematurely because of loss to follow-up, withdrawal of consent, investigator decision, and an unrelated death from a motor vehicle accident. The two shortened regimens elicited comparable antibody titres against autologous clade C Env at peak immunity to the longer, 12-month regimen: geometric mean titre (GMT) 41 007 (95% CI 17 959-93 636) for group 2 and 49 243 (29 346-82 630) for group 3 at week 28 compared with 44 590 (19 345-102 781) for group 1 at week 52). Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72. Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses were detected in all groups. All vaccine regimens were well tolerated. Mild-to-moderate pain or tenderness at the injection site was the most commonly reported solicited local adverse event, reported by 28 vaccine recipients (93%) and two placebo recipients (33%). Grade 3 solicited systemic adverse events were reported by eight (27%) vaccine recipients and no placebo recipients; the most commonly reported grade 3 systemic symptoms were fatigue, myalgia, and chills. The shortened group 3 regimen induced comparable peak immune responses in 30 rhesus monkeys as in humans and resulted in an 83% (95% CI 38·7-95, p=0·004 log-rank test) reduction in per-exposure acquisition risk after six intrarectal challenges with SHIV-SF162P3 at week 54, more than 6 months after final vaccination.
INTERPRETATION
Short, 6-month regimens of a mosaic HIV-1 prophylactic vaccine elicited robust HIV-specific immune responses that were similar to responses elicited by a longer, 12-month schedule. Preclinical data showed partial protective efficacy of one of the short vaccine regimens in rhesus monkeys. Further clinical studies are required to test the suitability of the shortened vaccine regimens in humans. Such shortened regimens would be valuable to increase vaccine delivery at the community level, particularly in resource-limited settings.
FUNDING
Ragon Institute (Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA) and Janssen Vaccines & Prevention (Leiden, Netherlands).",2020,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"['HIV (5', 'rhesus monkeys (NHP 17-22', 'All participants who received at least one vaccine dose or', 'healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement', 'HIV expressing mosaic HIV-1', 'Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study', 'rhesus monkeys']","['placebo', '0·5 mL of 0·9% saline', 'aluminium phosphate-adjuvanted clade C gp140 protein', 'vaccine or placebo']","['Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses', 'Mild-to-moderate pain or tenderness', 'tolerated', 'Grade 3 solicited systemic adverse events', 'grade 3 systemic symptoms were fatigue, myalgia, and chills', 'safety, tolerability, and immunogenicity', 'partial protective efficacy', 'Env-specific binding antibody responses', 'peak immune responses', 'safety and tolerability', 'Antibody responses', 'protective efficacy', 'safety analysis; immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0051519', 'cui_str': 'aluminium phosphate'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",36.0,0.574721,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Quijada', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Bondzie', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30001-1']
3695,31374475,Intranasal oxytocin reduces reactive aggression in men but not in women: A computational approach.,"Aggression is an important behaviour that concerns individual survival and large-scale social stability. It comprises a variety of psychological subcomponents and is modulated by different biological factors. Two factors in particular, gender and oxytocin, appear to play a robust role in aggressive behaviour. However, whether these two factors interact to impact aggressive behaviour is not currently known. The current study investigated the modulating effect of gender on the relationship between oxytocin and aggression and characterized its underlying mechanisms by combining behavioural economic, pharmacological, and computational approaches. Specifically, we employed a double-blind, randomized, placebo-controlled, between-subjects design, in which one hundred participants (50 men and 50 women) completed a norm-training version of the multi-round one-shot ultimatum game (UG) after intranasal oxytocin or placebo administration. Rejection rates in the UG were adopted as an indicator of reactive aggression. The results indicated that oxytocin compared with placebo administration decreased aggression among men but not among women. Further analyses suggested that this decrease in aggression was a result of changes in men's sensitivity to provocation and positive affect, rather than norm adaptation rates or concerns about the cost of aggression. These findings highlight the role of gender in the relationship between oxytocin and reactive aggression and reveal its underlying psychological and computational mechanisms.",2019,"Further analyses suggested that this decrease in aggression was a result of changes in men's sensitivity to provocation and positive affect, rather than norm adaptation rates or concerns about the cost of aggression.","['men but not in women', 'one hundred participants (50 men and 50 women']","['Intranasal oxytocin', 'placebo', 'norm-training version of the multi-round one-shot ultimatum game (UG) after intranasal oxytocin or placebo administration', 'oxytocin']","['Rejection rates', 'reactive aggression', 'aggression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}]",100.0,0.320067,"Further analyses suggested that this decrease in aggression was a result of changes in men's sensitivity to provocation and positive affect, rather than norm adaptation rates or concerns about the cost of aggression.","[{'ForeName': 'Ruida', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China; Center for Collaboration and Innovation in Brain and Learning Sciences, Beijing Normal University, Beijing, China; Beijing Key Laboratory of Brain Imaging and Connectomics, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China; Center for Collaboration and Innovation in Brain and Learning Sciences, Beijing Normal University, Beijing, China; Beijing Key Laboratory of Brain Imaging and Connectomics, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Institute for Brain Research and Rehabilitation (IBRR), South China Normal University, Guangzhou, China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China; Center for Collaboration and Innovation in Brain and Learning Sciences, Beijing Normal University, Beijing, China; Beijing Key Laboratory of Brain Imaging and Connectomics, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Fung', 'Affiliation': 'Division of Humanities and Social Sciences and Computation and Neural Systems Program, California Institute of Technology, Pasadena, USA.'}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Guangdong Provincial Key Laboratory of Mental Health and Cognitive Science, Center for Studies of Psychological Application, School of Psychology, South China Normal University, Guangzhou, China. Electronic address: chunliang.feng@gmail.com.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Division of Humanities and Social Sciences and Computation and Neural Systems Program, California Institute of Technology, Pasadena, USA; CAS Key Laboratory of Behavioral Science, Institute of Psychology, Department of Psychology, University of Chinese Academy of Sciences, Beijing, China. Electronic address: haiyanwu@caltech.edu.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Fralin Biomedical Research Institute at VTC, Virginia Tech, Roanoke, USA. Electronic address: luoyi0704@gmail.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Collaborative Innovation Center of Assessment toward Basic Education Quality, Beijing Normal University, Beijing, China. Electronic address: mykd3210@gmail.com.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.06.016']
3696,31610549,Rivaroxaban Versus Vitamin K Antagonist in Antiphospholipid Syndrome: A Randomized Noninferiority Trial.,"Background
The potential role of new oral anticoagulants in antiphospholipid antibody syndrome (APS) remains uncertain.
Objective
To determine whether rivaroxaban is noninferior to dose-adjusted vitamin K antagonists (VKAs) for thrombotic APS.
Design
3-year, open-label, randomized noninferiority trial. (EU Clinical Trials Register: EUDRA [European Union Drug Regulatory Authorities] code 2010-019764-36).
Setting
6 university hospitals in Spain.
Participants
190 adults (aged 18 to 75 years) with thrombotic APS.
Intervention
Rivaroxaban (20 mg/d or 15 mg/d, according to renal function) versus dose-adjusted VKAs (target international normalized ratio, 2.0 to 3.0, or 3.1 to 4.0 in patients with a history of recurrent thrombosis).
Measurements
The primary efficacy outcome was the proportion of patients with new thrombotic events; the primary safety outcome was major bleeding. The prespecified noninferiority margin for risk ratio (RR) was 1.40. Secondary outcomes included time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding.
Results
After 3 years of follow-up, recurrent thrombosis occurred in 11 patients (11.6%) in the rivaroxaban group and 6 (6.3%) in the VKA group (RR in the rivaroxaban group, 1.83 [95% CI, 0.71 to 4.76]). Stroke occurred more commonly in patients receiving rivaroxaban (9 events) than in those receiving VKAs (0 events) (corrected RR, 19.00 [CI, 1.12 to 321.9]). Major bleeding occurred in 6 patients (6.3%) in the rivaroxaban group and 7 (7.4%) in the VKA group (RR, 0.86 [CI, 0.30 to 2.46]). Post hoc analysis suggested an increased risk for recurrent thrombosis in rivaroxaban-treated patients with previous arterial thrombosis, livedo racemosa, or APS-related cardiac valvular disease.
Limitation
Anticoagulation intensity was not measured in the rivaroxaban group.
Conclusion
Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
Primary Funding Source
Bayer Hispania.",2019,"Conclusion
Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","['Setting\n\n\n6 university hospitals in Spain', 'Participants\n\n\n190 adults (aged 18 to 75 years) with thrombotic APS', 'Antiphospholipid Syndrome']","['Rivaroxaban Versus Vitamin K Antagonist', 'vitamin K antagonists (VKAs', 'rivaroxaban', 'Rivaroxaban']","['risk ratio (RR', 'Major bleeding', 'Limitation\n\n\nAnticoagulation intensity', 'proportion of patients with new thrombotic events; the primary safety outcome was major bleeding', 'recurrent thrombosis', 'time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding', 'Stroke']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0085278', 'cui_str': 'Antiphospholipid Antibody Syndrome'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",190.0,0.206485,"Conclusion
Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Ordi-Ros', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Sáez-Comet', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Pérez-Conesa', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vidal', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Riera-Mestre', 'Affiliation': 'Bellvitge University Hospital-IDIBELL, Barcelona, Spain (A.R.).'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castro-Salomó', 'Affiliation': 'Sant Joan de Reus University Hospital, Reus, Spain (A.C.).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cuquet-Pedragosa', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Ortiz-Santamaria', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Mauri-Plana', 'Affiliation': 'Mataró Hospital, Mataró, Spain (M.M.).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Solé', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Cortés-Hernández', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}]",Annals of internal medicine,['10.7326/M19-0291']
3697,32078337,Reducing training frequency from 3 or 4 sessions/week to 2 sessions/week does not attenuate improvements in maximal aerobic capacity with reduced-exertion high-intensity interval training (REHIT).,"In the present randomised-controlled trial we investigated the effect of reduced-exertion high-intensity interval training (REHIT) training frequency (2, 3, or 4 sessions/week for 6 weeks) on maximal aerobic capacity in 42 inactive individuals (13 women; mean ± SD age: 25 ± 5 years, maximal aerobic capacity: 35 ± 5 mL·kg -1 ·min -1 ). Changes in maximal aerobic capacity were not significantly different between the 3 groups (2 sessions/week: +10.2%; 3 sessions/week: +8.1%; 4 sessions per week: +7.3%). In conclusion, a training frequency of 2 sessions/week is sufficient for REHIT to improve maximal aerobic capacity. Novelty We demonstrate that reducing REHIT training frequency from 3 or 4 to 2 sessions/week does not attenuate improvements in the key health marker of maximal aerobic capacity.",2020,Changes in V̇O2max were not significantly different between the three groups (2 sessions/week: +10.2%; 3 sessions/week: +8.1%; 4 sessions per week: +7.3%).,"['42 inactive individuals (13 women; mean±SD age: 25±5 y, V̇O2max: 35±5 mL·kg-1·min-1']",['REHIT training frequency'],"['maximal aerobic capacity with reduced-exertion high-intensity interval training (REHIT', 'maximal aerobic capacity (V̇O2max', 'Changes in V̇O2max', 'Novelty']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",42.0,0.0158426,Changes in V̇O2max were not significantly different between the three groups (2 sessions/week: +10.2%; 3 sessions/week: +8.1%; 4 sessions per week: +7.3%).,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'School of Sport & Exercise Science, University of Worcester, Worcester, WR2 6AJ, UK.'}, {'ForeName': 'Preeyaphorn', 'Initials': 'P', 'LastName': 'Songsorn', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Gorman', 'Affiliation': 'Sport and Exercise Sciences Research Institute, Ulster University, BT37 0QB, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Brackenridge', 'Affiliation': 'Sport and Exercise Sciences Research Institute, Ulster University, BT37 0QB, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cullen', 'Affiliation': 'School of Sport & Exercise Science, University of Worcester, Worcester, WR2 6AJ, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Fitzpatrick', 'Affiliation': 'Sport and Exercise Sciences Research Institute, Ulster University, BT37 0QB, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Metcalfe', 'Affiliation': 'Applied Sports Science Technology and Medicine Research Centre (A-STEM), Swansea University, Swansea, SA1 8EN, UK.'}, {'ForeName': 'Niels B J', 'Initials': 'NBJ', 'LastName': 'Vollaard', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0750']
3698,31343582,A Motivational Telephone Intervention to Reduce Early Dropouts in Cardiac Rehabilitation: A FEASIBILITY PILOT STUDY.,"PURPOSE
Cardiac rehabilitation (CR) improves outcomes, yet early dropout is common. The purpose of the study was to determine whether a motivational telephone intervention among patients at risk for nonadherence would reduce early dropouts.
METHODS
We performed a randomized double-blind pilot study with the intervention group receiving the telephone intervention 1 to 3 d after outpatient CR orientation. The control group received the standard of care, which did not routinely monitor attendance until 2 wk after orientation. The primary outcome was the percentage of patients who attended their second exercise session as scheduled. Secondary outcomes included attendance at the second CR session at any point and total number of sessions attended. Because not everyone randomized to the intervention was able to be contacted, we also conducted a per-protocol analysis.
RESULTS
One hundred patients were randomized to 2 groups (age 62 ± 15 yr, 46% male, 40% with myocardial infarction) with 49 in the intervention group. Patients who received the intervention were more likely to attend their second session as scheduled compared with the standard of care (80% vs 49%; relative risk = 1.62; 95% CI, 1.18-2.22). Although there was no difference in total number of sessions between groups, there was a statistically significant improvement in overall return rate among the per-protocol group (87% vs 66%; relative risk = 1.31; 95% CI, 1.05-1.63).
CONCLUSIONS
A nursing-based telephone intervention targeted to patients at risk for early dropout shortly after their CR orientation improved both on-time and eventual return rates. This straightforward strategy represents an attractive adjunct to improve adherence to outpatient CR.",2019,"Although there was no difference in total number of sessions between groups, there was a statistically significant improvement in overall return rate among the per-protocol group (87% vs 66%; relative risk = 1.31; 95% CI, 1.05-1.63).
","['Cardiac Rehabilitation', 'One hundred patients were randomized to 2 groups (age 62 ± 15 yr, 46% male, 40% with myocardial infarction) with 49 in the intervention group', 'patients at risk for nonadherence would reduce early dropouts']","['Cardiac rehabilitation (CR', 'motivational telephone intervention', 'Motivational Telephone Intervention', 'telephone intervention']","['attendance at the second CR session at any point and total number of sessions attended', 'total number of sessions', 'overall return rate']","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",100.0,0.133681,"Although there was no difference in total number of sessions between groups, there was a statistically significant improvement in overall return rate among the per-protocol group (87% vs 66%; relative risk = 1.31; 95% CI, 1.05-1.63).
","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'LaValley', 'Affiliation': 'Baystate Health Systems, Springfield, Massachusetts (Drs LaValley, Farah, and Pack and Mrs Szalai); Elms College, Chicopee, Massachusetts (Drs LaValley and Storer); University of Massachusetts Medical School at Baystate, Springfield (Dr Pack); and Center for Health Care Delivery and Population Science, Springfield, Massachusetts (Dr Pack).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Storer', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Szalai', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Farah', 'Affiliation': ''}, {'ForeName': 'Quinn R', 'Initials': 'QR', 'LastName': 'Pack', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000425']
3699,32076105,Noninvasive neuromodulation of the prefrontal cortex in young women with obesity: a randomized clinical trial.,"BACKGROUND/OBJECTIVES
Obesity is associated with reduced neurocognitive performance. Individuals with obesity show decreased activation in the left dorsolateral prefrontal cortex (DLPFC), a key brain region relevant to the regulation of eating behavior. Transcranial direct current stimulation (tDCS) has emerged as a potential technique to correct these abnormalities. However, there is limited information to date, particularly in clinical settings and regarding long-term effects of tDCS. This study aimed to investigate the effects of DLPFC-targeted tDCS in young women with obesity.
SUBJECT/METHODS
Randomized, double-blind, sham-controlled parallel-design clinical trial conducted in 38 women, aged 20-40 years, with BMI 30-35 kg/m 2 .
STUDY DESIGN
Phase I: target engagement (immediate effects of tDCS on working memory performance), Phase II: tDCS only (ten sessions, 2 weeks), Phase III: tDCS + hypocaloric diet (six sessions, 30% energy intake reduction, 2 weeks, inpatient), Phase IV: follow-up at 1, 3, and 6 months.
PRIMARY OUTCOME
change in body weight.
SECONDARY OUTCOMES
change in eating behavior and appetite. Additional analyses: effect of Catechol-O-methyl transferase (COMT) gene variability. Data were analyzed as linear mixed models.
RESULTS
There was no group difference in change in body weight during the tDCS intervention. At follow-up, the active group lost less weight than the sham group. In addition, the active group regained weight at 6-month follow-up, compared with sham. Genetic analysis indicated that COMT Met noncarriers were the subgroup that accounted for this paradoxical response in the active group.
CONCLUSION
Our results suggest that in young women with class I obesity, tDCS targeted to the DLPFC does not facilitate weight loss. Indeed, we found indications that tDCS could have a paradoxical effect in this population, possibly connected with individual differences in dopamine availability. Future studies are needed to confirm these findings.",2020,"Individuals with obesity show decreased activation in the left dorsolateral prefrontal cortex (DLPFC), a key brain region relevant to the regulation of eating behavior.","['young women with obesity', '38 women, aged 20-40 years, with BMI 30-35\u2009kg/m 2 ', 'young women with class I obesity', 'Individuals with obesity']","['Transcranial direct current stimulation (tDCS', 'DLPFC-targeted tDCS', 'tDCS', 'Catechol-O-methyl transferase (COMT', 'tDCS\u2009+\u2009hypocaloric diet']","['body weight', 'eating behavior and appetite', 'working memory performance']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007413', 'cui_str': 'o-Dihydroxybenzenes'}, {'cui': 'C0040676', 'cui_str': 'Transferase'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0474423', 'cui_str': 'Eating behavior and appetite (finding)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",38.0,0.208513,"Individuals with obesity show decreased activation in the left dorsolateral prefrontal cortex (DLPFC), a key brain region relevant to the regulation of eating behavior.","[{'ForeName': 'Priscila Giacomo', 'Initials': 'PG', 'LastName': 'Fassini', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Energy Metabolism Laboratory, Jean Mayer USDA Human Nutrition Center on Aging, Tufts University, 711 Washington Street, Boston, MA, 02111-1524, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'Júlio Sérgio', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Wilson Araújo', 'Initials': 'WA', 'LastName': 'da Silva Junior', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Isabela Rozatte', 'Initials': 'IR', 'LastName': 'da Silva', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Rafaella', 'Initials': 'R', 'LastName': 'de Souza Ribeiro Salgueiro', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Cássia Dias', 'Initials': 'CD', 'LastName': 'Machado', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Vivian Marques Miguel', 'Initials': 'VMM', 'LastName': 'Suen', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Bairro Monte Alegre, CEP, Ribeirão Preto, São Paulo, 14049-900, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA. migalonsoalonso@alumni.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-020-0545-3']
3700,32073468,Improvement and Retention of Arthroscopic Skills in Novice Subjects Using Fundamentals of Arthroscopic Surgery Training (FAST) Module.,"INTRODUCTION
Analysis of the Fundamentals of Arthroscopy Surgery Training (FAST) workstation regarding increased proficiency and retention of basic arthroscopy skills in novice subjects.
METHODS
First-year medical students from a single allopathic medical school performed weekly standardized FAST workstation modules for a consecutive 6 weeks. Primary outcomes evaluated were time to task completion and error rate on specific modules. Scores were analyzed using a one-way repeated measures analysis of variance design for overall trends in time and errors over the 6-week study. Psychomotor retention was analyzed after a 12-week and 24-week interlude.
RESULTS
Across the initial 6-week study, the average time to complete all modules at the workstation decreased significantly (P < 0.001) with a mean reduction in the total workstation time of 21.9 minutes (s = 8.12 minutes). Weekly comparisons showed the most significant improvement from week 1 to week 2 for the total workstation time (P < 0.001). Results after a 12-week and 24-week interval of inactivity demonstrated no significant difference in the mean workstation time or errors when compared with the original 6-week study.
DISCUSSION
The FAST workstation significantly improved the task performance of novice participants over a 6-week period with no significant deterioration in task performance after 12 and 24 weeks of inactivity.",2020,The FAST workstation significantly improved the task performance of novice participants over a 6-week period with no significant deterioration in task performance after 12 and 24 weeks of inactivity.,"['Novice Subjects Using Fundamentals of Arthroscopic Surgery Training (FAST) Module', 'novice subjects', 'First-year medical students from a single allopathic medical school performed weekly']","['standardized FAST workstation modules', 'Arthroscopy Surgery Training (FAST) workstation']","['Psychomotor retention', 'Improvement and Retention of Arthroscopic Skills', 'mean workstation time or errors', 'task performance', 'total workstation time', 'proficiency and retention of basic arthroscopy skills', 'time to task completion and error rate on specific modules']","[{'cui': 'C0750934', 'cui_str': 'Arthroscopic Surgical Procedures'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0036378', 'cui_str': 'Schools, Medical'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1736830', 'cui_str': 'Workstation (physical object)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1736830', 'cui_str': 'Workstation (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]",,0.0143021,The FAST workstation significantly improved the task performance of novice participants over a 6-week period with no significant deterioration in task performance after 12 and 24 weeks of inactivity.,"[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Meeks', 'Affiliation': 'From the Department of Orthopaedic Surgery (Dr. Meeks, Dr. Kiskaddon, Dr. Froehle, Shroyer), Wright State University, Dayton, OH, the Boonshoft School of Medicine (Sirois), Wright State University, Dayton, OH, and the Department of Orthopaedic Surgery (Dr. Laughlin), University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kiskaddon', 'Affiliation': ''}, {'ForeName': 'Zachary J', 'Initials': 'ZJ', 'LastName': 'Sirois', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Froehle', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Shroyer', 'Affiliation': ''}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Laughlin', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-19-00336']
3701,31302052,Risk Models for Prediction of Implantable Cardioverter-Defibrillator Benefit: Insights From the DANISH Trial.,"OBJECTIVES
This study aims to identify patients with nonischemic heart failure who are more likely to benefit from implantable cardioverter-defibrillator (ICD) implantation by use of established risk prediction models.
BACKGROUND
It has been debated whether an ICD for primary prevention reduces mortality in patients with nonischemic heart failure.
METHODS
The Seattle Heart Failure Model (SHFM) predicts all-cause mortality whereas the Seattle Proportional Risk Model (SPRM) predicts the proportion of sudden cardiac death (SCD) versus nonsudden death, with a higher score indicating a greater proportion of SCD. We report the effect of ICD implantation on all-cause mortality and SCD, according to median SPRM and SHFM scores in all 1,116 patients enrolled in the DANISH (Danish study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on mortality) trial.
RESULTS
Among patients with an SPRM score above the median (n = 558), ICD implantation reduced all-cause mortality (hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.43 to 0.94), whereas patients with lower SPRM scores (n = 558) had no effect (HR: 1.08; 95% CI: 0.78 to 1.49, p for interaction = 0.04). The corresponding numbers for SHFM score above and below the median were HR: 0.84; 95% CI: 0.62 to 1.13 and HR: 0.82; 95% CI: 0.53 to 1.28, respectively (p for interaction = 0.980). In 177 patients with upper SPRM/upper SHFM, ICD implantation reduced all-cause mortality (HR: 0.45; 95% CI: 0.25 to 0.80) when compared to 381 patients with lower SPRM/upper SHFM (HR: 1.09; 95% CI: 0.76 to 1.55) (p for interaction <0.001).
CONCLUSIONS
Nonischemic heart failure patients with high predicted relative likelihood of SCD, as estimated by higher SPRM score, seemed to benefit from ICD implantation. (DANISH [Danish ICD Study in Patients With Ditaled Cardiomyopathy]; NCT00542945).",2019,"In 177 patients with upper SPRM/upper SHFM, ICD implantation reduced all-cause mortality (HR: 0.45; 95% CI: 0.25 to 0.80) when compared to 381 patients with lower SPRM/upper SHFM (HR: 1.09; 95% CI: 0.76 to 1.55) (p for interaction <0.001).
","['patients with nonischemic heart failure', 'Patients With Ditaled Cardiomyopathy', 'Patients with Non-ischemic Systolic Heart\xa0Failure on mortality) trial', 'patients with nonischemic heart failure who are more likely to benefit from', '1,116 patients enrolled in the DANISH (Danish study', '177 patients with upper SPRM']","['implantable cardioverter-defibrillator (ICD) implantation', 'ICD implantation']","['SPRM score', 'upper SHFM, ICD implantation reduced all-cause mortality', 'SPRM scores', 'SHFM score', 'sudden cardiac death (SCD) versus nonsudden death', 'cause mortality', 'median SPRM and SHFM scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1135191', 'cui_str': 'Heart Failure, Systolic'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",1116.0,0.0587595,"In 177 patients with upper SPRM/upper SHFM, ICD implantation reduced all-cause mortality (HR: 0.45; 95% CI: 0.25 to 0.80) when compared to 381 patients with lower SPRM/upper SHFM (HR: 1.09; 95% CI: 0.76 to 1.55) (p for interaction <0.001).
","[{'ForeName': 'Søren Lund', 'Initials': 'SL', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark. Electronic address: slk@heart.dk.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Levy', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Shadman', 'Affiliation': 'Southern California Permanente Medical Group, Los Angeles, California.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haarbo', 'Affiliation': 'Department of Cardiology, Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Niels E', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark; Clinical Institute, Copenhagen and Aalborg Universities, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eiskjær', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wiggers', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Brandes', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anna Margrethe', 'Initials': 'AM', 'LastName': 'Thøgersen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Dan E', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': 'Analysis Group, Boston, Massachusetts.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Jens Jakob', 'Initials': 'JJ', 'LastName': 'Thune', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.03.019']
3702,31720933,Health-Related Quality of Life After Cytoreductive Surgery/HIPEC for Mucinous Appendiceal Cancer: Results of a Multicenter Randomized Trial Comparing Oxaliplatin and Mitomycin.,"BACKGROUND
This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin.
METHODS
In this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m 2 ) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally.
RESULTS
Baseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks (p = 0.044; score difference 6.35) and 24 weeks after surgery (p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI (p = 0.004; score decline 8.99), PWB (p < 0.001; score decline 2.83), and FWB (p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group.
CONCLUSIONS
Compared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC.",2020,"Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017).","['mucinous appendiceal cancer patients undergoing CRS/HIPEC', 'Mucinous Appendiceal Cancer', '121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS', 'subjects with mucinous appendiceal neoplasms who underwent']","['mitomycin, HIPEC perfusion with oxaliplatin', 'mitomycin with oxaliplatin', 'Oxaliplatin and Mitomycin', 'cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC', 'mitomycin', 'Cytoreductive Surgery/HIPEC', 'HIPEC', 'Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire', 'oxaliplatin']","['FWB', 'Baseline physical well-being (PWB', 'PWB', 'overall survival', 'physical and functional outcomes', 'TOI', 'Health-Related Quality of Life']","[{'cui': 'C0496779', 'cui_str': 'Appendiceal Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C4087504', 'cui_str': 'Peritoneal dissemination'}, {'cui': 'C0003614', 'cui_str': 'Appendiceal Neoplasms'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.159859,"Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017).","[{'ForeName': 'Omeed', 'Initials': 'O', 'LastName': 'Moaven', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Konstantinos I', 'Initials': 'KI', 'LastName': 'Votanopoulos', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mansfield', 'Affiliation': 'Department of Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Bartlett', 'Affiliation': 'Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Russell', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McQuellon', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stewart', 'Affiliation': 'Department of Surgery, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Levine', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA. elevine@wakehealth.edu.'}]",Annals of surgical oncology,['10.1245/s10434-019-08064-6']
3703,32079840,Influence of angle kappa on visual and refractive outcomes after implantation of a diffractive trifocal intraocular lens.,"PURPOSE
To evaluate changes in angle kappa following the implantation of a trifocal intraocular lens (IOL), and to assess the postoperative outcomes of patients with different angle kappa values.
SETTING
IOA Madrid Innova Ocular, Madrid, Spain DESIGN:: Prospective trial METHODS:: Sixty-three patients due to have bilateral implantation of the diffractive trifocal IOL (POD F, PhysIOL, Belgium) were included. Pupil offset was used as the best estimate of angle kappa and was measured using Pentacam (Oculus, Wetzlar, Germany) preoperatively and at 3-months after surgery. Postoperative refractive outcomes (sphere, cylinder, and MRSE) and visual outcomes at far, intermediate and near distance were assessed and compared between eyes with small pupil offset and eyes with large pupil offset. Quality of vision was assessed using a subjective questionnaire.
RESULTS
There was significant decrease in pupil offset post-operatively (mean: 0.197 ± 0.12 mm) compared to preoperatively (mean: 0.239 ± 0.12 mm), with a mean decrease of -0.042 mm (P = 0.0002). The same significant decrease was found for both the right eyes and left eyes, when analysed separately. No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset. The majority of patients (14 out of 16) complaining of significant halos had eyes with small pupil offset.
CONCLUSION
Large pupil offset did not negatively affect visual and refractive outcomes. The tolerance to larger pupil offset might be due to the IOL optical design, with the first diffractive ring being larger than other commonly used multifocal IOLs. More studies comparing various diffractive IOL models will be useful to confirm such hypothesis.",2020,No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset.,"['patients with different angle kappa values', ' Sixty-three patients due to have bilateral implantation of the diffractive trifocal IOL (POD F, PhysIOL, Belgium) were included']",['trifocal intraocular lens (IOL'],"['Quality of vision', 'refractive and visual acuity outcomes', 'pupil offset post-operatively', 'Postoperative refractive outcomes (sphere, cylinder, and MRSE) and visual outcomes at far, intermediate and near distance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocals'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",63.0,0.0300334,No statistically significant difference was found in any of the refractive and visual acuity outcomes between eyes with small pupil offset and eyes with large pupil offset.,"[{'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Garzón', 'Affiliation': 'IOA Madrid Innova Ocular, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'García-Montero', 'Affiliation': 'Department of Optica II, Complutense University, Madrid, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'López-Artero', 'Affiliation': 'IOA Madrid Innova Ocular, Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Albarrán-Diego', 'Affiliation': 'Clínica Oftalmológica Dr Gonzalo Muñoz, Valencia, Valencia.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Pérez-Cambrodí', 'Affiliation': 'Department of Ophthalmology (Oftalmar), Vithas Medimar International Hospital, Alicante, Spain.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Illarramendi', 'Affiliation': 'Begitek, Innova Ocular, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Poyales', 'Affiliation': 'IOA Madrid Innova Ocular, Madrid, Spain.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000156']
3704,31373563,The Effect of Postoperative Telephone Counseling on the Sexual Life of Patients With a Bowel Stoma: A Randomized Controlled Trial.,"Sexual problems following ileostomy or colostomy surgery are common.
PURPOSE
The purpose of this study was to determine the effect of telephone counseling on the sexual lives of individuals with a bowel stoma.
METHOD
Using a randomized, controlled, quasi-experimental study design, patients who were between 18 and 70 years old, had a sexual partner, and had undergone ileostomy or colostomy surgery were eligible to participate. Patients were randomized to telephone counseling as needed (intervention) or regular outpatient follow-up care only (control) for 12 weeks following surgery. Sociodemographic data were collected, and the Golombok-Rust Inventory of Sexual Satisfaction (GRISS) was completed on admission for surgery and 6 and 12 weeks postoperatively. Data were analyzed using descriptive statistics and the Mann-Whitney U , Kruskal-Wallis, Friedman, Wilcoxon signed ranks, and chi-squared tests and Yates's correction for continuity.
RESULTS
Of the 70 participants (35 in each group), the average age of intervention group participants was 53.00 ± 11.18 years, and the average age of the control group was 50.74 ± 13.72 years; 19 (54.3%) in the intervention group and 18 (51.4%) in the control group were male. Neither the demographic data nor the GRISS scale scores were significantly different between groups at baseline. After discharge, patients in the intervention group called to receive counseling for their concerns regarding sexual life and challenges they experienced with their stoma an average of 3.57 ± 0.86 (range 2-5) times during the first 6 weeks and 6.52 ±.77 (range 5-8) times between weeks 6 and 12. Mean total and subscale GRISS scores improved significantly from 5.89 ± 1.33 to 7.33 ± 1.24 ( P <.01).
CONCLUSION
In this study, telephone counseling was effective in improving the sexual lives of patients with a colon- or ileostoma 12 weeks after surgery.",2019,"In this study, telephone counseling was effective in improving the sexual lives of patients with a colon- or ileostoma 12 weeks after surgery.","['patients with a colon- or ileostoma 12 weeks after surgery', 'Patients With a Bowel Stoma', 'patients who were between 18 and 70 years old, had a sexual partner, and had undergone ileostomy or colostomy surgery were eligible to participate', 'average age of intervention group participants was 53.00 ± 11.18 years, and the average age of the control group was 50.74 ± 13.72 years; 19 (54.3%) in the intervention group and 18 (51.4%) in the control group were male', 'individuals with a bowel stoma', '70 participants (35 in each group']","['ileostomy or colostomy surgery', 'telephone counseling', 'telephone counseling as needed (intervention) or regular outpatient follow-up care only (control', 'Postoperative Telephone Counseling']","['Golombok-Rust Inventory of Sexual Satisfaction (GRISS', 'sexual lives', 'Mean total and subscale GRISS scores', 'GRISS scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0020883', 'cui_str': 'Ileostomy'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0020883', 'cui_str': 'Ileostomy'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",70.0,0.042944,"In this study, telephone counseling was effective in improving the sexual lives of patients with a colon- or ileostoma 12 weeks after surgery.","[{'ForeName': 'Seçil', 'Initials': 'S', 'LastName': 'Taylan', 'Affiliation': 'Akdeniz University, Kumluca-Antalya, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Akıl', 'Affiliation': 'Çukurova University, Adana, Turkey.'}]",Wound management & prevention,[]
3705,31373564,"Effect of Using a Simulation Device for Ostomy Self-care Teaching in Iran: A Pilot, Randomized Clinical Trial.","The appearance of a stoma and the potential for contact with stool may negatively affect postoperative teaching effectiveness, especially for patients with cultural and religious backgrounds that consider stool untouchable. Instruction that involves the use of a physical stoma simulator for practice may help address this problem.
PURPOSE
The aim of this pilot study was to determine the effects of simulation in ostomy self-care training on self-efficacy and adjustment.
METHODS
A randomized clinical trial was conducted among patients at 2 public medical center surgical units in eastern Iran from April 2015 to December 2015 using consecutive sampling. Patients who spoke Persian, were 18 to 65 years of age, had a temporary or permanent intestinal stoma, and did not have comorbidities that might interfere with self-care teaching were invited to participate and randomly allocated to the simulation (SG) or the control group (CG). Both groups were provided 4 training sessions; the first and fourth session was the same for each group, but in sessions 2 and 3, the SG group used a wearable stoma simulator, whereas the CG group used the demonstration-return method. Demographic and stoma variables were collected, and the Stoma Self-Efficacy Scale (SSES) and Ostomy Adjustment Inventory-23 (OAI-23) were administered at baseline (following surgery), after 4 instructional sessions, and 45 days following the last education session. Descriptive statistics and chi-squared, Fisher's exact, Mann-Whitney U , repeated measure, and least significant difference tests were used to analyze the data.
RESULTS
Of the 53 patients enrolled, 46 (23 in each group) completed the study. Mean age for SG and CG patients was 45.91 ± 10.40 and 53.78 ± 9.15, respectively ( P = .009). The majority of patients were female (SG: 11 [47.8%]; CG: 14 [60.9%]), married (SG: 20 [87.0%]; CG: 19 [82.6%]), and had a diagnosis of cancer (SG: 20 [87.0%]; CG: 21 [91.3%]). The mean SSES score for stoma self-efficacy was 103.82 ± 15.81 in the SG and 89.91 ± 13.41 in the CG after the fourth session. Results indicated an improvement in self-efficacy in both groups from baseline to final follow-up visit ( P <.0001). SSES in the SG was significantly different from baseline to final follow-up visit during the study (F = 3.183, P = .008). Mean OAI-23 scores were 51.04 ± 13.37 in the SG and 50.82 ± 13.84 in the CG at baseline and after the intervention (fourth session) were 60.56 ± 16.41 in the SG and 53.95 ± 13.22 in the CG group. The repeated measure test results indicated significant increases in adjustment scores from baseline to final follow-up visit in both groups ( P = .000).
CONCLUSION
The results of this pilot study suggest that using simulation to teach ostomy self-care improves self-efficacy after 3 and 9 weeks. Further randomized controlled trials that expand the sample size and demographic should be conducted.",2019,Results indicated an improvement in self-efficacy in both groups from baseline to final follow-up visit ( P <.0001).,"['Ostomy Self-care Teaching in Iran', 'patients at 2 public medical center surgical units in eastern Iran from April 2015 to December 2015 using consecutive sampling', 'Patients who spoke Persian, were 18 to 65 years of age, had a temporary or permanent intestinal stoma, and did not have comorbidities that might interfere with self-care teaching', '53 patients enrolled, 46 (23 in each group) completed the study']","['Simulation Device', 'SG group used a wearable stoma simulator', 'simulation (SG) or the control group (CG', 'ostomy self-care training']","['Stoma Self-Efficacy Scale (SSES) and Ostomy Adjustment Inventory-23 (OAI-23', 'mean SSES score for stoma self-efficacy', 'self-efficacy', 'Mean OAI-23 scores']","[{'cui': 'C0029473', 'cui_str': 'Ostomy'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0559494', 'cui_str': 'Intestinal stoma (morphologic abnormality)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0521102', 'cui_str': 'Interferes with (contextual qualifier) (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029473', 'cui_str': 'Ostomy'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}, {'cui': 'C0029473', 'cui_str': 'Ostomy'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0282028,Results indicated an improvement in self-efficacy in both groups from baseline to final follow-up visit ( P <.0001).,"[{'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Pouresmail', 'Affiliation': 'Mashhad University of the Sciences, Mashhad, Iran.'}, {'ForeName': 'Fatemeh Heshmati', 'Initials': 'FH', 'LastName': 'Nabavi', 'Affiliation': 'Mashhad University of the Sciences, Mashhad, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Abdollahi', 'Affiliation': 'Mashhad University of the Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Shakeri', 'Affiliation': 'Mashhad University of the Sciences, Mashhad, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Saki', 'Affiliation': 'Mashhad University of the Sciences, Mashhad, Iran.'}]",Wound management & prevention,[]
3706,32070647,The Feasibility of the Ultrasound-Guided Femoral Nerve Block Procedure with Low-Dose Local Anesthetic in Intracapsular and Extracapsular Hip Fractures.,"BACKGROUND
The local anesthetic dosages used in the current literature in regional applications of local anesthetics are frequently high for surgical purposes, and there are no sufficient dosage studies for emergency department (ED) management.
OBJECTIVES
The aim of this study was to determine the success of lower local anesthetic dosages capable of reducing costs and excessive exposure to drugs in pain control in patients with femoral neck fractures (FNFs) in the ED.
METHODS
Patients ≥65 years of age with FNFs and reporting Wong-Baker Pain Rating Scales scores ≥8 were included in this prospective, interventional study. Patients underwent ultrasound-guided regional femoral block with 5 mL 2% prilocaine. Pain scores before the procedure and at 30 min and 2 h postprocedure were compared with the Friedman test and Wilcoxon test with Bonferroni correction.
RESULTS
Forty patients, 20 with intracapsular and 20 with extracapsular FNFs, were enrolled. The initial pain scores of patients with both intra- and extracapsular fractures were 8 (range 8-10). A statistically significant 50% decrease in pain scores was observed in both groups 30 min after the regional block procedure (p < 0.001). A statistically significant 75% decrease in pain scores was observed in both groups 2 h after the regional block procedure (p < 0.001). No statistically significant difference was determined in the change in 30-min and 2-h pain scores between the groups.
CONCLUSIONS
The administration of 5 mL 2% prilocaine for pain control in FNFs in elderly patients in the ED can reduce systemic analgesic requirements by establishing effective analgesia in both intracapsular and extracapsular fractures.",2020,"No statistically significant difference was determined in the change in 30-min and 2-h pain scores between the groups.
","['Intracapsular and Extracapsular Hip Fractures', 'Forty patients, 20 with intracapsular and 20 with extracapsular FNFs, were enrolled', 'patients with femoral neck fractures (FNFs', 'elderly patients', 'Patients ≥65\xa0years of age with FNFs and reporting Wong-Baker Pain Rating Scales scores ≥8']","['prilocaine', 'Ultrasound-Guided Femoral Nerve Block Procedure with Low-Dose Local Anesthetic', 'ultrasound-guided regional femoral block with 5\xa0mL 2% prilocaine']","['change in 30-min and 2-h pain scores', 'initial pain scores', 'pain scores', 'systemic analgesic requirements', 'Pain scores']","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.0603779,"No statistically significant difference was determined in the change in 30-min and 2-h pain scores between the groups.
","[{'ForeName': 'Fatih Esad', 'Initials': 'FE', 'LastName': 'Topal', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Bilgin', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Yamanoglu', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Karakaya', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Payza', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Pınar Yesim', 'Initials': 'PY', 'LastName': 'Akyol', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Aslan', 'Affiliation': 'Department of Orthopaedics and Traumatology, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Aksun', 'Affiliation': 'Department of Anesthesiology, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.12.033']
3707,32011032,A randomized controlled study comparing guided bone regeneration with connective tissue graft to re-establish buccal convexity: One-year aesthetic and patient-reported outcomes.,"OBJECTIVES
To compare guided bone regeneration (GBR) with connective tissue graft (CTG) in terms of aesthetic and patient-reported outcomes (PROMs).
MATERIALS AND METHODS
Patients with a single tooth gap in the anterior maxilla and horizontal alveolar defect were enrolled in a single-blind RCT. All sites had a buccopalatal bone dimension of at least 6 mm, received a single implant and were randomly allocated to the control (GBR) or test group (CTG) to re-establish buccal soft tissue convexity. Primary outcomes were Pink Esthetic Score (PES) and Mucosal Scarring Index (MSI) assessed after 1 year. Secondary outcomes included PROMs registered during the early stages of healing and after 1 year.
RESULTS
Twenty-one patients were included per group (control: 11 females, mean age 51; test: nine females, mean age 48). Although there was no significant difference in the PES between the groups (control: 10.11; test: 10.48; p = .577), the MSI was significantly lower in the test (1.10) than in the control group (2.53) (p = .017). Based on descriptive statistics, the latter demonstrated wider scars, more colour mismatch and slightly more suture marks. However, these were not considered disturbing by the patients given similar VAS on soft tissue aesthetics (control: 84; test: 87). Oedema and haematoma were rated twice as high in the control group on at least two postoperative time points, and patients took more painkillers (7.10 vs. 4.86). OHIP-14 decreased in both groups between baseline and 1-year follow-up, indicative of less discomfort in daily life. Differences in MSI and PROMs between the groups may be explained by the need of a vertical releasing incision in order to achieve sufficient access for GBR, periosteal incisions and the use of biomaterials that may induce inflammation.
CONCLUSION
GBR and CTG resulted in favourable aesthetic outcomes as assessed by professionals and patients. However, given additional vertical and periosteal incisions, GBR resulted in more scarring, postoperative discomfort and a higher need for painkillers.",2020,Oedema and hematoma were rated twice as high in the control group on at least two postoperative time points and patients took more painkillers (7.10 versus 4.86).,"['Twenty-one patients were included per group (control: 11 females', 'mean age 51; test: 9 females, mean age 48', 'Patients with a single tooth gap in the anterior maxilla and horizontal alveolar defect were enrolled in a single-blind RCT']","['GBR and CTG', 'control (GBR) or test group (CTG) to re-establish buccal soft tissue convexity', 'guided bone regeneration with connective tissue graft to re-establish buccal convexity', 'guided bone regeneration (GBR) with connective tissue graft (CTG', 'VAS']","['PROMs registered during the early stages of healing and after 1 year', 'favorable aesthetic outcomes', 'PES', 'MSI', 'soft tissue aesthetics', 'Oedema and hematoma', 'OHIP-14', 'scarring, postoperative discomfort', 'Pink Esthetic Score (PES) and Mucosal Scarring Index (MSI']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0332585', 'cui_str': 'Pink color (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",21.0,0.0967303,Oedema and hematoma were rated twice as high in the control group on at least two postoperative time points and patients took more painkillers (7.10 versus 4.86).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'De Bruyckere', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Cosyn', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}, {'ForeName': 'Faris', 'Initials': 'F', 'LastName': 'Younes', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Hellyn', 'Affiliation': 'Department of Periodontology and Oral Implantology, Faculty of Medicine and Health Sciences, Dental School, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bekx', 'Affiliation': 'Department of Periodontology and Oral Implantology, Faculty of Medicine and Health Sciences, Dental School, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cleymaet', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}, {'ForeName': 'Aryan', 'Initials': 'A', 'LastName': 'Eghbali', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}]",Clinical oral implants research,['10.1111/clr.13587']
3708,32012053,Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial.,"BACKGROUND
In addition to medication, health behavior management is crucial in patients with multiple risks of cardiovascular mortality.
OBJECTIVE
This study aimed to examine the efficacy of a 3-month Smart Management Strategy for Health-based electronic program (Smart Healthing).
METHODS
A 2-arm randomized controlled trial was conducted to assess the efficacy of Smart Healthing in 106 patients with at least one indicator of poor disease control and who had hypertension, diabetes, or hypercholesterolemia. The intervention group (n=53) took part in the electronic program, which was available in the form of a mobile app and a Web-based PC application. The program covered 4 areas: self-assessment, self-planning, self-learning, and self-monitoring by automatic feedback. The control group (n=53) received basic educational material concerning disease control. The primary outcome was the percentage of participants who achieved their clinical indicator goal after 12 weeks into the program: glycated hemoglobin (HbA 1c ) <7.0%, systolic blood pressure (SBP) <140 mmHg, or low-density lipoprotein cholesterol <130 mg/dL.
RESULTS
The intervention group showed a significantly higher success rate (in comparison with the control group) for achieving each of 3 clinical indicators at the targeted goal levels (P<.05). Only the patients with hypertension showed a significant improvement in SBP from the baseline as compared with the control group (72.7% vs 35.7%; P<.05). There was a significant reduction in HbA 1c in the intervention group compared with the control group (difference=0.54%; P≤.05). In the intervention group, 20% of patients with diabetes exhibited a ≥1% decrease in HbA 1c (vs 0% among controls; P≤.05).
CONCLUSIONS
A short-term self-management strategy-based electronic program intervention may improve clinical outcomes among patients with cardiovascular risks.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03294044; https://clinicaltrials.gov/ct2/show/NCT03294044.",2020,The intervention group showed a significantly higher success rate (in comparison with the control group) for achieving each of 3 clinical indicators at the targeted goal levels (P<.05).,"['106 patients with at least one indicator of poor disease control and who had hypertension, diabetes, or hypercholesterolemia', 'patients with cardiovascular risks', 'patients with multiple risks of cardiovascular mortality', 'Patients With Cardiovascular Risk']","['Smart Healthing', 'Electronic Health Management Program', 'basic educational material concerning disease control', 'electronic program intervention']","['systolic blood pressure (SBP', 'success rate', 'glycated hemoglobin (HbA 1c ', 'percentage of participants who achieved their clinical indicator goal', 'HbA 1c', 'SBP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",106.0,0.0616857,The intervention group showed a significantly higher success rate (in comparison with the control group) for achieving each of 3 clinical indicators at the targeted goal levels (P<.05).,"[{'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Yun', 'Affiliation': 'Seoul National University College of Medicine, Department of Family Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'EunKyo', 'Initials': 'E', 'LastName': 'Kang', 'Affiliation': 'Seoul National University College of Medicine, Department of Family Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Min', 'Initials': 'YM', 'LastName': 'Cho', 'Affiliation': 'Seoul National University College of Medicine, Department of Internal Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Seoul National University College of Medicine, Department of Family Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong-Jin', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Seoul National University College of Medicine, Department of Internal Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hae-Young', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'Seoul National University College of Medicine, Department of Internal Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyae Hyung', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Seoul National University College of Medicine, Department of Family Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kiheon', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Bundang Seoul National University Hospital, Department of Family Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Hye Yeon', 'Initials': 'HY', 'LastName': 'Koo', 'Affiliation': 'Bundang Seoul National University Hospital, Department of Family Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Soojeong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Seoul National University College of Medicine, Department of Family Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'YeEun', 'Initials': 'Y', 'LastName': 'Rhee', 'Affiliation': 'Seoul National University College of Medicine, Department of Family Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Seoul National University College of Medicine, Department of Family Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Hee', 'Initials': 'JH', 'LastName': 'Min', 'Affiliation': 'Seoul National University College of Medicine, Department of Family Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Ah', 'Initials': 'JA', 'LastName': 'Sim', 'Affiliation': 'Seoul National University College of Medicine, Cancer Research Institute, Seoul, Republic of Korea.'}]",Journal of medical Internet research,['10.2196/15057']
3709,31425230,Bilateral Thoracic Paravertebral Blocks Compared to Thoracic Epidural Analgesia After Midline Laparotomy: A Pragmatic Noninferiority Clinical Trial.,"BACKGROUND
Bilateral paravertebral block (PVB) is a suitable alternative to thoracic epidural analgesia (TEA) for abdominal surgeries. This randomized clinical trial aims to determine if PVB is noninferior to TEA in terms of analgesia after midline laparotomy.
METHODS
Seventy American Society of Anesthesiologists (ASA) class I-III patients undergoing a laparotomy through a midline incision were randomized to receive either TEA (TEA group) or continuous bilateral PVB (PVB group) as a part of a multimodal analgesia regimen in an open-label design. Noninferiority was to be concluded if the mean between-group difference in pain on movement at the 24 postoperative hours was within a margin of 2 points on a 0-10 numerical rating scale (NRS). Pain score at rest and on movement, analgesic consumption, hemodynamics, and adverse events during the first 72 postoperative hours were the secondary outcome measures assessed for superiority. Postblock and steady-state plasma concentrations of ropivacaine and pattern of dye spread were also recorded in the PVB group.
RESULTS
The primary outcome of pain scores on movement at 24 postoperative hours was noninferior in PVB group in comparison to TEA group (mean difference [95% confidence interval {CI}], 0.43 [-0.72-1.58]). The pain scores at rest and on movement at other time points of assessment were within clinically acceptable limits in both groups with no significant differences between the groups over time. Arterial plasma ropivacaine levels were within safe limits, while steady-state venous level was higher than an acceptable threshold in 9 of 34 cases.
CONCLUSIONS
As a component of multimodal analgesia, bilateral PVB provides noninferior analgesia compared to TEA for midline laparotomy.",2019,"The primary outcome of pain scores on movement at 24 postoperative hours was noninferior in PVB group in comparison to TEA group (mean difference [95% confidence interval {CI}], 0.43","['Seventy American Society of Anesthesiologists (ASA) class', 'I-III patients undergoing a laparotomy through a midline incision']","['TEA (TEA group) or continuous bilateral PVB (PVB group', 'Bilateral paravertebral block (PVB', 'Thoracic Epidural Analgesia', 'TEA', 'ropivacaine', 'Bilateral Thoracic Paravertebral Blocks']","['Pain score at rest and on movement, analgesic consumption, hemodynamics, and adverse events', 'Arterial plasma ropivacaine levels', 'steady-state venous level', 'pain', 'Postblock and steady-state plasma concentrations', 'pain scores on movement at 24 postoperative hours', 'pain scores']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0456276', 'cui_str': 'Midline incision (procedure)'}]","[{'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]",70.0,0.189979,"The primary outcome of pain scores on movement at 24 postoperative hours was noninferior in PVB group in comparison to TEA group (mean difference [95% confidence interval {CI}], 0.43","[{'ForeName': 'Rakesh V', 'Initials': 'RV', 'LastName': 'Sondekoppam', 'Affiliation': 'From the Department of Anesthesia and Pain Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Uppal', 'Affiliation': 'Department of Anesthesia, Pain Management & Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Brookes', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sugantha', 'Initials': 'S', 'LastName': 'Ganapathy', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Western University, London, Ontario, Canada.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004219']
3710,30623268,Effect of treatment on back pain and back extensor strength with a spinal orthosis in older women with osteoporosis: a randomized controlled trial.,"The treatment effect of an activating spinal orthosis on back pain and back extensor strength was compared to a training group and to a control group. Between the groups, there was no significant difference in back pain, back extensor strength, or kyphosis index after the 6 months of treatment.
PURPOSE
The aim of this study was to study the effect of treatment with an activating spinal orthosis on back pain, back extensor strength, and kyphotic index. Our hypothesis was that an activating spinal orthosis may be an alternative treatment to decrease back pain and increase back extensor strength.
METHODS
A total of 113 women aged ≥ 60 years with back pain and osteoporosis, with or without vertebral fractures, were randomized to three groups: a spinal orthosis group, an equipment training group, and a control group. All three groups were examined at baseline and followed up after 3 and 6 months. Statistical analyses were performed with a mixed model for repeated measures according to intention to treat (ITT) and per protocol (PP).
RESULTS
A total of 96 women completed the study. Between the groups, there was no significant difference in baseline characteristics. Comparison between groups showed no significant difference in back pain, back extensor strength, or kyphosis index at the follow-up after 6 months according to ITT and PP analyses. Analysis in each group showed that the back extensor strength had increased by 26.9% in the spinal orthosis group, by 22.1% in the exercise training group and by 9.9% in the control group.
CONCLUSIONS
Six months' treatment by an activating spinal orthosis showed no significant difference in back pain, back extensor strength, or kyphosis index between the three groups. In the spinal orthosis group, present back pain decreased slightly and back extensor strength increased by 26.9% which indicates that the spinal orthosis may become an alternative training method. Clinicaltrials.com ID: NCT03263585.",2019,"Between the groups, there was no significant difference in back pain, back extensor strength, or kyphosis index after the 6 months of treatment.
","['older women with osteoporosis', '60\xa0years with back pain and osteoporosis, with or without vertebral fractures', '96 women completed the study', '113 women aged ≥']","['exercise training', 'spinal orthosis group, an equipment training group, and a control group', 'activating spinal orthosis']","['back extensor strength', 'back pain decreased slightly and back extensor strength', 'back pain, back extensor strength, or kyphosis index', 'back pain and increase back extensor strength', 'back pain, back extensor strength, and kyphotic index', 'back pain and back extensor strength']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0022823'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",113.0,0.0269278,"Between the groups, there was no significant difference in back pain, back extensor strength, or kyphosis index after the 6 months of treatment.
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kaijser Alin', 'Affiliation': 'Division of Family Medicine and Primary Care, department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Solna, Sweden. christina.kaijser.alin@ki.se.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Uzunel', 'Affiliation': 'Division of Family Medicine and Primary Care, department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Ann-Charlotte', 'Initials': 'AC', 'LastName': 'Grahn Kronhed', 'Affiliation': 'Rehab Väst, Local Health Care Services in the West of Östergötland, Östergötland, Sweden.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Alinaghizadeh', 'Affiliation': 'Division of Family Medicine and Primary Care, department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Salminen', 'Affiliation': 'Division of Family Medicine and Primary Care, department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Solna, Sweden.'}]",Archives of osteoporosis,['10.1007/s11657-018-0555-0']
3711,32067724,Rhythmic auditory stimulation increases 6-Minute walk distance in individuals with COPD: A repeated measures study.,"OBJECTIVE
To evaluate if there is an increase in 6-minute walk distance in individuals with chronic obstructive pulmonary disease (COPD) while walking to rhythmically enhanced music.
BACKGROUND
Individuals with COPD are less active. Walking with rhythmically enhanced music may help Participant's walk farther while simultaneously distracting from symptoms of dyspnea.
METHODS
Twenty-five men (age = 70.7 ± 4.5 yr), with moderate-to-severe COPD (FEV1 = 47.4 ± 9.7% predicted) completed three, 6 min walk tests (6MWT) in random order. Walks were completed with music, with music that was rhythmically enhanced, or without music. Walking distance and perceived dyspnea were measured.
RESULTS
Participant's walked 12 m, 95% CI [20.5-, 2.6], p = 0.015 further during the 6MWT when listening to rhythmically enhanced music when compared to no music. Onset of dyspnea was not different between the three walking conditions.
CONCLUSIONS
Rhythmically-enhanced music may be a useful tool to increase walking distance in Participant's with COPD.",2020,"RESULTS
Participant's walked 12 m, 95% CI [20.5-, 2.6], p = 0.015 further during the 6MWT when listening to rhythmically enhanced music when compared to no music.","['Twenty-five men (age\xa0=\xa070.7\xa0±', 'individuals with chronic obstructive pulmonary disease (COPD', 'Individuals with COPD', 'individuals with COPD']","['Rhythmic auditory stimulation', 'Walking with rhythmically enhanced music']","['Onset of dyspnea', '6-Minute walk distance', 'walking distance', 'Walking distance and perceived dyspnea', '6-minute walk distance']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",,0.162271,"RESULTS
Participant's walked 12 m, 95% CI [20.5-, 2.6], p = 0.015 further during the 6MWT when listening to rhythmically enhanced music when compared to no music.","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hernandez', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Center for Education in Health Science and Outcomes Research, 633 N St. Clair, 20th Floor (2024-J), Chicago, IL 60611; University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: lison.hernandez@northwestern.com.'}, {'ForeName': 'Ulf G', 'Initials': 'UG', 'LastName': 'Bronas', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: bronas@uic.edu.'}, {'ForeName': 'Alana D', 'Initials': 'AD', 'LastName': 'Steffen', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: steffena@uic.edu.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'University of Illinois at Chicago, Department of Kinesiology and Nutrition, 1919 W. Taylor, Chicago IL 60612. Electronic address: marquezd@uic.edu.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fritschi', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: fritschi@uic.edu.'}, {'ForeName': 'Lauretta T', 'Initials': 'LT', 'LastName': 'Quinn', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612. Electronic address: lquinn1@uic.edu.'}, {'ForeName': 'Eileen G', 'Initials': 'EG', 'LastName': 'Collins', 'Affiliation': 'University of Illinois at Chicago, College of Nursing, 845 South Damen Ave, Chicago IL 60612; Edward Hines Jr., VA Hospital. Electronic address: ecollins@uic.edu.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.01.006']
3712,32061508,Felodipine and renal function in lung transplantation: A randomized placebo-controlled trial.,"BACKGROUND
Calcium channel blockers may ameliorate the decline in renal function caused by calcineurin inhibitors in lung transplantation (LTX) recipients. We hypothesized that pre-operative and 12-week post-operative treatment with the calcium channel blocker felodipine would reduce the decline in glomerular filtration rate (GFR).
METHODS
In this prospective, randomized, double-blind trial, 39 LTX recipients were transplanted and received placebo (n = 19; GFR, 102 ml/min/1.73 m 2 [range, 91-113 ml/min/1.73 m 2 ]) or felodipine (n = 20, GFR, 96 ml/min/1.73 m 2 [range, 88-104 ml/min/1.73 m 2 ]). Pre-operative treatment was titrated post-operatively to 10 mg or the maximum tolerable dose. The primary end-point was the change in GFR using Cr-51-labeled EDTA from LTX to 12 weeks thereafter, and follow-up was 52 weeks.
RESULTS
The treatment group showed an absolute mean decline in GFR of 31 ml/min/1.73 m 2 (95% CI: -40 to 22 ml/min/1.73 m 2 ), whereas that of the placebo group was 48 ml/min/1.73 m 2 (95% confidence interval [CI]: -56 to 40 ml/min/1.73 m 2 ). Thus, the difference between groups at 12 weeks was 17 ml/min/1.73 m 2 (95% CI: 4-29 ml/min/1.73 m 2 ; p = 0.01). Half of the patients were unable to complete the 3-month primary follow-up, and the analysis includes these patients by intention-to-treat. After 52 weeks (40 weeks after termination of treatment), the treatment effect was maintained at 12 ml/min/1.73 m 2 (95% CI: 0-24 ml/min/1.73 m 2 , p = 0.05). The number of days with registered hypotension was significantly higher in the felodipine group than in the placebo group (39 days vs 13 days, rate ratio: 2.9 [95% CI: 1.5-5.3]).
CONCLUSIONS
Use of felodipine in select patients was associated with greater preservation in renal function early (90 days) after LTX. The observed benefits were attenuated by 1 year, although trends in better renal function were noted.",2020,The treatment group showed an absolute mean decline in GFR of 31 ml/min/1.73 m 2 ,"['lung transplantation', 'lung transplantation (LTX) recipients', '39 LTX recipients were transplanted and received']","['Felodipine', 'placebo', 'calcium channel blocker felodipine', 'felodipine', 'Calcium channel blockers']","['change in GFR', 'glomerular filtration rate (GFR', 'renal function', 'absolute mean decline in GFR', 'number of days with registered hypotension']","[{'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C0015772', 'cui_str': 'Felodipine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",39.0,0.589463,The treatment group showed an absolute mean decline in GFR of 31 ml/min/1.73 m 2 ,"[{'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Hornum', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. Electronic address: mads.hornum@regionh.dk.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Iversen', 'Affiliation': 'Department of Cardiology, Section for Lung Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oturai', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads J', 'Initials': 'MJ', 'LastName': 'Andersen', 'Affiliation': 'Department of Cardiology, Section for Lung Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Zemtsovski', 'Affiliation': 'Department of Cardiothoracic Anesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Bredahl', 'Affiliation': 'Department of Cardiothoracic Anesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nina H', 'Initials': 'NH', 'LastName': 'Bjarnason', 'Affiliation': 'Department of Cardiology, Section for Lung Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Carlsen', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Perch', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Section for Lung Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1342']
3713,31962003,Parental knowledge and attitudes regarding asthma in their children: Impact of an educational intervention in an Indian population.,"INTRODUCTION AND OBJECTIVES
Research shows positive effects of asthma education in improving parental knowledge, self-management skills, and reducing healthcare costs. Such studies are lacking in resource-limited countries. We studied the effectiveness of educational intervention in improving the knowledge and attitudes of parents/caregivers of asthmatic children.
METHODS
The study was conducted in the pediatric chest clinic of tertiary hospital (India) over 21 months after ethics committee approval. Recruited parents were randomized into the interventional group (A) receiving education module and control group (B). Parents' asthma knowledge and attitudes were assessed at baseline and 5 months postenrollment using 25-item questionnaire. Detailed demographic data, clinical data, and exacerbations during study were noted.
RESULTS
A total of 75 parents/guardians fulfilling inclusion criteria were analyzed (cases/group A: 37 and controls/group B: 38). 8.3 percent of parents/caregivers were illiterate. Around 36.9% of patients had a family history of allergy/asthma. Mean knowledge scores at follow-up were 12.24 and 9.89 for groups A and B, respectively (P < .05). Parents did better on knowledge items related to chronicity, family history, chronic cough, home administration of steroids in acute severe asthma, and maintaining records of clinical/medications for good control. Intervention group (A) showed significant improvement in most attitude-based questions postintervention as compared with the nonintervention group (B). There was no statistically significant difference in asthma severity and control between the two groups at follow-up.
CONCLUSIONS
Small group education on asthma in parents/caregivers improves their knowledge and attitudes. Healthcare plans should invest in pediatric asthma education and identify key personnel/opportunities to impart the same in routine care.",2020,Intervention group (A) showed significant improvement in most attitude-based questions postintervention as compared with the nonintervention group (B).,"['Indian population', 'parents/caregivers of asthmatic children', 'pediatric chest clinic of tertiary hospital (India) over 21 months after ethics committee approval', 'A total of 75 parents/guardians fulfilling inclusion criteria were analyzed']","['interventional group (A) receiving education module and control group (B', 'educational intervention']","['knowledge and attitudes', 'most attitude-based questions postintervention', 'Mean knowledge scores', 'asthma severity and control', ""Parents' asthma knowledge and attitudes""]","[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",75.0,0.0375521,Intervention group (A) showed significant improvement in most attitude-based questions postintervention as compared with the nonintervention group (B).,"[{'ForeName': 'Chhaya A', 'Initials': 'CA', 'LastName': 'Divecha', 'Affiliation': 'Department of Pediatrics, Seth G. S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Milind S', 'Initials': 'MS', 'LastName': 'Tullu', 'Affiliation': 'Department of Pediatrics, Seth G. S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Devika U', 'Initials': 'DU', 'LastName': 'Jadhav', 'Affiliation': 'Department of Pediatrics, Seth G. S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.'}]",Pediatric pulmonology,['10.1002/ppul.24647']
3714,31376016,Assessment of photobiomodulation therapy by an 8l0-nm diode laser on the reversal of soft tissue local anesthesia in pediatric dentistry: a preliminary randomized clinical trial.,"During the injection of local anesthesia in pediatric dental procedures, from the injection time until the elimination of tissue anesthesia, inevitable problems were reported. According to the encouraging results of previous studies addressing the positive effects of laser therapy on increasing the microcirculation, we aimed to investigate the clinical effect of photobiomodulation therapy on the reversal of soft tissue anesthesia in children. Using a split-mouth design, 34 children aged 4 to 8 years old, candidate for receiving local infiltration injection at both right and left side in mandible, were enrolled in the study. The mandibular right and left quadrants were randomly assigned to groups of laser or sham laser: in laser side, patients received 810-nm laser irradiation, and in the sham laser group, the patients had the laser in off mode at 45 min after injection with an interval of 7-10 days between two sessions of each quadrant treatments. The degree of anesthesia was evaluated using the palpation technique alternately every 15 min. Data were analyzed using paired sample t test and multiple linear regression test. The mean duration of anesthesia expressed in minutes was equal to 145.15 ± 23.27 and 188.82 ± 12.31 for the laser group and sham laser group, respectively. There was a significant difference in duration of anesthesia between two groups (P < 0.001). Considering the results and limitations of the present study, photobiomodulation therapy by 810-nm diode laser can be proposed as a non-invasive method in order to reduce the duration of anesthesia in pediatric patients.",2020,There was a significant difference in duration of anesthesia between two groups (P < 0.001).,"['children', '34 children aged 4 to 8\xa0years old, candidate for receiving local infiltration injection at both right and left side in mandible, were enrolled in the study', 'pediatric dentistry', 'pediatric patients']","['photobiomodulation therapy by an 8l0-nm diode laser', 'photobiomodulation therapy by 810-nm diode laser', 'laser therapy', 'photobiomodulation therapy', 'laser or sham laser: in laser side, patients received 810-nm laser irradiation']","['degree of anesthesia', 'duration of anesthesia', 'mean duration of anesthesia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030763', 'cui_str': 'Pedodontics'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",34.0,0.0256938,There was a significant difference in duration of anesthesia between two groups (P < 0.001).,"[{'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Seraj', 'Affiliation': 'Dental Research Center, Department of Pediatric Dentistry, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ghadimi', 'Affiliation': 'Laser Research Center of Dentistry, Department of Pediatric Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Hakimiha', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Kharazifard', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hosseini', 'Affiliation': 'Department of Pediatric Dentistry, Tehran University of Medical Sciences, Tehran, Iran. zahrahosseini69@gmail.com.'}]",Lasers in medical science,['10.1007/s10103-019-02850-0']
3715,31365109,Immediate Antihypertensive Treatment for Patients With Acute Ischemic Stroke With or Without History of Hypertension: A Secondary Analysis of the CATIS Randomized Clinical Trial.,"Importance
Clinical trials have generally shown a neutral effect of early blood pressure (BP) decreases on clinical outcomes after acute ischemic stroke. Whether the effect of early antihypertensive therapy differs for patients with ischemic stroke with or without prior hypertension is unclear.
Objective
To investigate the association between immediate antihypertensive treatment and patient outcomes according to the presence or absence of hypertension before stroke onset.
Design, Setting, and Participants
This study was a prespecified subgroup analysis of the China Antihypertensive Trial in Acute Ischemic Stroke (CATIS), a multicenter, single-blind, blinded end-points randomized clinical trial of 4071 patients with acute ischemic stroke and elevated systolic BP. Patients were recruited from August 2009 to May 2013, and this statistical analysis was performed using the intention-to-treat population from January to October 2018.
Interventions
Participants were randomly assigned to receive antihypertensive treatment (aimed at decreasing systolic BP by 10%-25% within the first 24 hours after randomization, achieving systolic BP <140 mm Hg and diastolic BP <90 mm Hg within 7 days, and maintaining this level during hospitalization) or to the control arm (discontinued all antihypertensive medications).
Main Outcomes and Measures
Primary outcome was a combination of death and major disability (modified Rankin Scale score ≥3; range 0-6, with higher values indicating greater disability) at 14 days or hospital discharge.
Results
In total, 2038 patients were randomized to receive antihypertensive treatment, and 2033 patients were randomized to the control group. The mean (SD) age was 62.0 (10.9) years, and 2604 participants (64.0%) were men. At day 14 or hospital discharge, the primary outcome was not different between the treatment and control groups among patients with or without prior hypertension (P = .97 for homogeneity): odds ratios (ORs) associated with treatment were 1.00 (95% CI, 0.87-1.16) for patients with prior hypertension and 1.00 (95% CI, 0.75-1.32) for patients without. Early antihypertensive treatment was associated with different rates of 3-month recurrent stroke (patients with hypertension: OR, 0.44; 95% CI, 0.25-0.77 vs without hypertension: OR, 3.43; 95% CI, 0.94-12.55; P = .005 for homogeneity) and vascular events (patients with hypertension: OR, 0.66; 95% CI, 0.43-1.02 vs those without hypertension: OR, 1.91; 95% CI, 0.75-4.83; P = .04 for homogeneity) by hypertension history.
Conclusions and Relevance
Among patients with acute ischemic stroke, early antihypertensive treatment was not associated with different death and major disability outcomes by hypertension history. However, early antihypertension therapy was associated with a decreased rate of recurrent stroke among patients with a history of hypertension and may inform future studies in the optimal approach to hypertension management in the setting of acute ischemic stroke.
Trial Registration
ClinicalTrials.gov identifier: NCT01840072.",2019,"At day 14 or hospital discharge, the primary outcome was not different between the treatment and control groups among patients with or without prior hypertension (P = .97 for homogeneity):","['patients with ischemic stroke with or without prior hypertension is unclear', 'Patients With Acute Ischemic Stroke', '2038 patients were randomized to receive antihypertensive treatment, and 2033 patients', 'Patients were recruited from August 2009 to May 2013, and this statistical analysis was performed using the intention-to-treat population from January to October 2018', 'patients with acute ischemic stroke', 'The mean (SD) age was 62.0 (10.9) years, and 2604 participants (64.0%) were men', '4071 patients with acute ischemic stroke and elevated systolic BP', 'Hypertension']",['antihypertensive treatment'],"['combination of death and major disability (modified Rankin Scale score ≥3; range 0-6, with higher values indicating greater disability) at 14 days or hospital discharge', 'rates of 3-month recurrent stroke', 'systolic BP', 'systolic BP <140 mm Hg and diastolic BP', 'odds ratios (ORs', 'rate of recurrent stroke', 'vascular events', 'blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]","[{'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",2038.0,0.226513,"At day 14 or hospital discharge, the primary outcome was not different between the treatment and control groups among patients with or without prior hypertension (P = .97 for homogeneity):","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Chongke', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhengbao', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Chung-Shiuan', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Affiliated Hospital of North China University of Science and Technology, Hebei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Qunwei', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, Taishan Medical College, Shandong, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Ju', 'Affiliation': ""Department of Neurology, Kerqin District First People's Hospital of Tongliao City, Inner Mongolia, China.""}, {'ForeName': 'Deqin', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Xuzhou Medical College, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8103']
3716,31364992,Use of 2 Types of Air-cell Mattresses for Pressure Ulcer Prevention and Comfort Among Patients With Advanced-stage Cancer Receiving Palliative Care: An Interventional Study.,"Patients with advanced- or terminal-stage cancer and persons receiving palliative care are at high risk for pressure ulcers (PUs).
PURPOSE
The purpose of this study was to examine the rate of PU development and levels of comfort of a dual-fit, air-cell mattress compared with an alternating, 2-layer overlay air-cell mattress in patients with advanced- or terminal-stage cancer receiving palliative care.
METHODS
From January 2011 to December 2013, hospitalized patients with advanced- or terminal-stage cancer who were referred to a palliative care team, at least 20 years of age, able to communicate, experiencing pain, and did not have a PU were recruited to participate. Patients who consented were alternately placed on the intervention (dual-fit, air-cell) or control (2-layer air) mattress until hospital discharge or death. Demographic and clinical data, pain scores, performance status, Palliative Performance Scale scores, Braden Scale scores, tissue interface pressure, and comfort were assessed via interview using closed-end questions. If a PU developed, clinical characteristics were assessed using DESIGN-R. Descriptive statistics and the Mann-Whitney U, chi-squared, and Fisher's exact tests were used to analyze the data.
RESULTS
Of the 123 eligible patients, 73 were randomized and 52 completed the study (23 intervention patients, median age 63 [range 27-80] years; and 29 control group patients, median age 61.0 [range 27-82] years). Mattresses were used a median of 17 (range 4-113) days in the intervention group and a median of 32 (range 3-270) days in the control group. The incidence of PUs did not significantly differ between the 2 groups (13% in the intervention and 17.2% in the control group). Interface pressures were significantly higher in the intervention group (27.0 mm Hg vs. 24.3 mm Hg). Comfort scores at rest were significantly better in the intervention than in the control group (sinking into bed [3 vs. 14, respectively]; slipping on bed [o vs. 16, respectively]; and feel pressure of air cell [2 vs. 14, respectively]), as were scores with movement (instability during movement [4 vs. 18, respectively] and feeling of floating of the buttocks [6 vs. 21, respectively]) (P <.05).
CONCLUSION
Dual-fit, air-cell mattresses may help prevent PUs and improve comfort at rest and during activity among patients with end-stage cancer receiving palliative care. Further research regarding mattress selection protocols for this patient population is warranted.",2019,Interface pressures were significantly higher in the intervention group (27.0 mm Hg vs. 24.3 mm Hg).,"['From January 2011 to December 2013, hospitalized patients with advanced- or terminal-stage cancer who were referred to a palliative care team, at least 20 years of age, able to communicate, experiencing pain, and did not have a PU were recruited to participate', 'Patients with advanced- or terminal-stage cancer and persons receiving palliative care are at high risk for pressure ulcers (PUs', '123 eligible patients, 73 were randomized and 52 completed the study (23 intervention patients, median age 63 [range 27-80] years; and 29 control group patients, median age 61.0', 'patients with advanced- or terminal-stage cancer receiving palliative care', 'patients with end-stage cancer receiving palliative care', 'Patients With Advanced-stage Cancer Receiving Palliative Care']","['dual-fit, air-cell mattress compared with an alternating, 2-layer overlay air-cell mattress', 'intervention (dual-fit, air-cell) or control (2-layer air) mattress until hospital discharge or death', 'Air-cell Mattresses']","['Pressure Ulcer Prevention and Comfort', 'incidence of PUs', 'Comfort scores', 'rate of PU development and levels of comfort', 'Interface pressures', 'Demographic and clinical data, pain scores, performance status, Palliative Performance Scale scores, Braden Scale scores, tissue interface pressure, and comfort were assessed via interview using closed-end questions', 'feel pressure of air cell', 'feeling of floating of the buttocks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2364293', 'cui_str': 'Able to communicate (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0741884', 'cui_str': 'End stage cancer'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}, {'cui': 'C0444456', 'cui_str': 'Overlay (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0150315', 'cui_str': 'Pressure sore protection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4720846', 'cui_str': 'Palliative performance scale'}, {'cui': 'C0222045'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0006497', 'cui_str': 'Buttocks'}]",73.0,0.0697972,Interface pressures were significantly higher in the intervention group (27.0 mm Hg vs. 24.3 mm Hg).,"[{'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Marutani', 'Affiliation': 'Graduate School of Medical Sciences, Kanazawa University, and Kanazawa University Hospital, Ishikawa, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Okuwa', 'Affiliation': 'Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, and Kanazawa University Hospital, Ishikawa, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Sugama', 'Affiliation': 'Institute for Frontier Science Initiative, Kanazawa University, Ishikawa, Japan.'}]",Wound management & prevention,[]
3717,32062791,Phase 3 Multicenter Study of Revusiran in Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR).,"PURPOSE
The Phase 3 ENDEAVOUR study evaluated revusiran, an investigational RNA interference therapeutic targeting hepatic transthyretin (TTR) production, for treating cardiomyopathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis.
METHODS
Patients with hATTR amyloidosis with cardiomyopathy were randomized 2:1 to receive subcutaneous daily revusiran 500 mg (n = 140) or placebo (n = 66) for 5 days over a week followed by weekly doses. Co-primary endpoints were 6-min walk test distance and serum TTR reduction.
RESULTS
Revusiran treatment was stopped after a median of 6.71 months; the study Sponsor prematurely discontinued dosing due to an observed mortality imbalance between treatment arms. Eighteen (12.9%) patients on revusiran and 2 (3.0%) on placebo died during the on-treatment period. Most deaths in both treatment arms were adjudicated as cardiovascular due to heart failure (HF), consistent with the natural history of the disease. A post hoc safety investigation of patients treated with revusiran found that, at baseline, a greater proportion of those who died were ≥ 75 years and showed clinical evidence of more advanced HF compared with those who were alive throughout treatment. Revusiran pharmacokinetic exposures and TTR lowering did not show meaningful differences between patients who died and who were alive. Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
CONCLUSIONS
Causes for the observed mortality imbalance associated with revusiran were thoroughly investigated and no clear causative mechanism could be identified. Although the results suggest similar progression of cardiac parameters in both treatment arms, a role for revusiran cannot be excluded.
CLINICAL TRIAL REGISTRATION
NCT02319005.",2020,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","['Patients with hATTR amyloidosis with cardiomyopathy', 'Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR']","['Revusiran', 'subcutaneous daily revusiran 500\xa0mg (n\u2009=\u2009140) or placebo']","['6-min walk test distance and serum TTR reduction', 'echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events', 'mortality imbalance', 'Revusiran pharmacokinetic exposures and TTR lowering']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]","[{'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0976805,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Judge', 'Affiliation': 'Johns Hopkins Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Arnt V', 'Initials': 'AV', 'LastName': 'Kristen', 'Affiliation': 'Department of Cardiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Grogan', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Rodney H', 'Initials': 'RH', 'LastName': 'Falk', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Gillmore', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK.'}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Harrop', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Karsten', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vest', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Hawkins', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK. p.hawkins@ucl.ac.uk.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-019-06919-4']
3718,31641967,"The effect of photobiomodulation therapy on nonsurgical periodontal treatment in patients with type 2 diabetes mellitus: a randomized controlled, single-blind, split-mouth clinical trial.","Photobiomodulation therapy (PBMT) is a method currently used in the treatment of hard and soft tissue injuries due to its accelerating and enhancing effects on healing. In this study, we aimed to evaluate the possible additional benefits of applying PBMT with nonsurgical periodontal treatment in type 2 diabetes mellitus (DM) patients with chronic periodontitis (CP). Twenty-two type 2 DM patients with CP were enrolled in this clinical split-mouth study. Probing pocket depth (PPD), gingival index (GI), plaque index (PI), and clinical attachment level (CAL) were measured by intracaliber clinician (H.G.) at baseline and at 1 m, 3 m, and 6 m after treatment. Gingival crevicular fluid (GCF) samples were collected at baseline and at 1 week and 1 m, 3 m, and 6 m after treatment. According to split-mouth design, one randomly selected quadrant was treated with PBMT + nonsurgical periodontal treatment (NSPT) and the other quadrant was treated only non-surgical periodontal treatment. PBMT was applied the test quadrant on NSPT day and first, third, and seventh day after treatment at an energy density of 7.64 J/cm 2 . Repeated measures analysis of variance test was used for the intragroup comparison and a ""paired t test"" in the intergroup comparison of the clinical and laboratory findings. Comparing the test and control quadrant after treatment, the test quadrant showed significant decrease in PPD at 1 month, 3 months, and 6 months; in GI at 3 months and 6 months; in CAL at month 6; in GCF at 1 week, 1 month, 3 months, and 6 months; and in IL-1β data at 3 months in comparison to the control quadrant. In contrast, there was no statistically significant difference in PI data at all times. Within the limitation of this study, adjunct use of PBMT on NSPT in patient with DM may positively affect the clinical and biochemical parameters.",2020,"Probing pocket depth (PPD), gingival index (GI), plaque index (PI), and clinical attachment level (CAL) were measured by intracaliber clinician (H.G.) at baseline and at 1 m, 3 m, and 6 m after treatment.","['patients with type 2 diabetes mellitus', 'type 2 diabetes mellitus (DM) patients with chronic periodontitis (CP', 'Twenty-two type 2 DM patients with CP']","['PBMT', 'Photobiomodulation therapy (PBMT', 'PBMT + nonsurgical periodontal treatment (NSPT) and the other quadrant was treated only non-surgical periodontal treatment', 'photobiomodulation therapy', 'PBMT with nonsurgical periodontal treatment']","['IL-1β data', 'PI data', 'Probing pocket depth (PPD), gingival index (GI), plaque index (PI), and clinical attachment level (CAL', 'Gingival crevicular fluid (GCF) samples', 'PPD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]",22.0,0.0343894,"Probing pocket depth (PPD), gingival index (GI), plaque index (PI), and clinical attachment level (CAL) were measured by intracaliber clinician (H.G.) at baseline and at 1 m, 3 m, and 6 m after treatment.","[{'ForeName': 'Seda Sevinç', 'Initials': 'SS', 'LastName': 'Özberk', 'Affiliation': 'Şehitkamil Oral and Dental Healthy Center, Ministry of Healthy, Gaziantep, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Gündoğar', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Gaziantep, Gaziantep, Turkey. hgundogar@gmail.com.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Özkaya', 'Affiliation': 'Department of Endocrinology, Dr. Ersin Arslan Education and Research Hospital, Gaziantep, Turkey.'}, {'ForeName': 'İbrahim Levent', 'Initials': 'İL', 'LastName': 'Taner', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Gazi, Ankara, Turkey.'}, {'ForeName': 'Kamile', 'Initials': 'K', 'LastName': 'Erciyas', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Gaziantep, Gaziantep, Turkey.'}]",Lasers in medical science,['10.1007/s10103-019-02897-z']
3719,31830535,Rehabilitation of the upper arm early after stroke: Video games versus conventional rehabilitation. A randomized controlled trial.,"BACKGROUND
Few rehabilitation methods have proven their efficacy in increasing sensori-motor recovery and/or function of the upper limb (UL) after stroke. Video games (VGs) are promising tools in this indication.
OBJECTIVE
To compare UL rehabilitation by using VGs and conventional rehabilitation (CR) in patients with sub-acute stroke.
DESIGN
Single-blind, multicentric trial, with central randomization and stratification by center.
SETTING
Physical and rehabilitation medicine departments of 2 university hospitals.
PARTICIPANTS
Adults within 3 months after a first vascular cerebral accident, with UL Fugl Meyer Score (UL-FMS)<30/66 and without major cognitive impairment.
INTERVENTION
A 45-min additional session of conventional occupational therapy (OT) or a VG-based OT session as add-on therapy to usual rehabilitation programs, 5 days/week for 6 weeks.
MAIN OUTCOME MEASURES
Primary outcome: UL-FMS. Secondary outcome: Box and Block Test (BBT), Wolf Motor Function test (WMFT), Motor Activity Log (MAL), Barthel Index and quality of life (SF-36).
RESULTS
We included 51 patients (20 women) at a mean (SD) of 27.2 (19.4) days post-stroke (mean age 58 years [range 24-83]), 26 in the CR group and 25 in the VG group (23 in each group at 6-month follow-up). The mean duration of the additional rehabilitation session was similar in both groups: 29.3 (4.3) vs 28.0 (4.4) min in CR and VG groups. Shoulder pain occurred in 4 patients in the VG group versus 7 in the CR group. At day 45, gain in UL-FMS did not significantly differ between the groups (CR mean 17.8 [14.6] vs VG 24.1 [14.8]; P=0.10), whereas gain in BBT was doubled in the VG group (CR 7.4 [12.2] vs VG 15.7 [16.3]; P=0.02). At 6-month follow-up, the study was inconclusive about between-group differences in UL-FMS, BBT and other criteria. Post-hoc analysis showed that gains in UL-FMS or BBT were significantly higher in the VG than CR group for patients included within 30 days post-stroke.
CONCLUSION
In general, we cannot conclude that video gaming and conventional OT led to different long-term sensorimotor recovery of the UL after sub-acute stroke. However, when applied within the first month after stroke, video gaming was more efficient than conventional rehabilitation on both sensorimotor recovery and gross grasping function.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT01554449).",2020,"Post-hoc analysis showed that gains in UL-FMS or BBT were significantly higher in the VG than CR group for patients included within 30 days post-stroke.
","['51 patients (20 women) at a mean (SD) of 27.2 (19.4) days post-stroke (mean age 58 years', 'Physical and rehabilitation medicine departments of 2 university hospitals', 'Adults within 3 months after a first vascular cerebral accident, with UL Fugl Meyer Score (UL-FMS)<30/66 and without major cognitive impairment', 'Rehabilitation of the upper arm early after stroke', 'patients with sub-acute stroke']","['conventional occupational therapy (OT) or a VG-based OT session', 'UL rehabilitation by using VGs and conventional rehabilitation (CR', 'Video games versus conventional rehabilitation', 'Video games (VGs']","['BBT), Wolf Motor Function test (WMFT), Motor Activity Log (MAL), Barthel Index and quality of life (SF-36', 'Box and Block Test', 'gain in UL-FMS', 'gains in UL-FMS or BBT', 'mean duration of the additional rehabilitation session', 'gain in BBT', 'Shoulder pain', 'UL-FMS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031813', 'cui_str': 'Physiatrics'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1961149', 'cui_str': 'Accidental physical contact (event)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0446516', 'cui_str': 'Brachiums'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]",51.0,0.139946,"Post-hoc analysis showed that gains in UL-FMS or BBT were significantly higher in the VG than CR group for patients included within 30 days post-stroke.
","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Laffont', 'Affiliation': 'PRM Department, University of Montpellier, Hôpital Lapeyronie, Montpellier University Hospital, 191, boulevard du Doyen-Gaston-Giraud, 34291 Montpellier cedex 05, France; IFRH, Euromov, University of Montpellier, Montpellier, France. Electronic address: i-laffont@chu-montpellier.fr.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Froger', 'Affiliation': 'IFRH, Euromov, University of Montpellier, Montpellier, France; PRM Department, University of Montpellier, Nimes University Hospital, Grau du Roi, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jourdan', 'Affiliation': 'PRM Department, University of Montpellier, Hôpital Lapeyronie, Montpellier University Hospital, 191, boulevard du Doyen-Gaston-Giraud, 34291 Montpellier cedex 05, France; IFRH, Euromov, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Karima', 'Initials': 'K', 'LastName': 'Bakhti', 'Affiliation': 'PRM Department, University of Montpellier, Hôpital Lapeyronie, Montpellier University Hospital, 191, boulevard du Doyen-Gaston-Giraud, 34291 Montpellier cedex 05, France; IFRH, Euromov, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Liesjet E H', 'Initials': 'LEH', 'LastName': 'van Dokkum', 'Affiliation': 'Neuro Imagery Department, University of Montpellier, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Abdelkader', 'Initials': 'A', 'LastName': 'Gouaich', 'Affiliation': 'LIRMM, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Huei Yune', 'Initials': 'HY', 'LastName': 'Bonnin', 'Affiliation': 'PRM Department, University of Montpellier, Nimes University Hospital, Grau du Roi, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Armingaud', 'Affiliation': 'PRM Department, University of Montpellier, Nimes University Hospital, Grau du Roi, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Jaussent', 'Affiliation': 'Inserm, Clinical Research and Epidemiology Unit, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Marie Christine', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': 'Inserm, Clinical Research and Epidemiology Unit, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Le Bars', 'Affiliation': 'CNRS, L2C, University of Montpellier, Montpellier, France; Neuro Imagery Department, University of Montpellier, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'IFRH, Euromov, University of Montpellier, Montpellier, France; PRM Department, University of Montpellier, Nimes University Hospital, Grau du Roi, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Arquizan', 'Affiliation': 'Neurology Department, University of Montpellier, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gelis', 'Affiliation': 'PRM Department, Propara Center, Montpellier, France; Epsylon, Paul Valery University, Montpellier, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Mottet', 'Affiliation': 'IFRH, Euromov, University of Montpellier, Montpellier, France.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.10.009']
3720,32048133,The Effect of High Lactate Level on Mortality in Acute Heart Failure Patients With Reduced Ejection Fraction Without Cardiogenic Shock.,"BACKGROUND
We aimed to determine the effect of blood lactate levels on cardiovascular (CV) death and hospitalization for heart failure (HF) in acute HF patients with reduced left ventricular ejection fraction (EF).
METHODS
Eighty-five acute HF patients with reduced ejection fraction were divided into two groups according to admission blood lactate levels. 48 of them had low blood lactate levels (< 2 mmol/l) and 37 of them had high blood lactate levels (≥ 2 mmol/l). Patients with acute coronary syndrome, cardiogenic shock, sepsis and low blood pressure at admission were excluded from the study. Primary endpoint is the composite of cardiovascular (CV) death and hospitalization for heart failure (HHF) in 6-month follow-up. Secondary endpoint is the change in NT-proBNP levels from admission to 72 h.
RESULTS
Baseline characteristics of patients were similar in two groups. On baseline echocardiographic evaluation; patients with high lactate revealed a higher mitral E/A ratio (2.34 [0.43-3.31], p = 0.008) and a lower TAPSE ratio (14 [10-27], p = 0.008) than patients with low lactate levels. Over a median follow-up period of 6 months, the primary end point occurred in 28 (75.7%) of 37 patients assigned to high lactate group and in 20 (41.7%) of 48 patients assigned to low lactate group (p = 0.006). High lactate levels significantly increased the risk of CV death and HHF at 6 months by nearly 5.35-fold in acute HF patients with reduced EF. The change in NT-proBNP levels at 72nd hour after admission were similar between two groups.
CONCLUSION
Higher lactate levels at admission related with higher HHF at 6 months and may be related with higher risk of CV death in acute HF patients with reduced EF.",2020,High lactate levels significantly increased the risk of CV death and HHF at 6 months by nearly 5.35-fold in acute HF patients with reduced EF.,"['acute HF patients with reduced EF', 'Eighty-five acute HF patients with reduced ejection fraction', 'Patients with acute coronary syndrome, cardiogenic shock, sepsis and low blood pressure at admission were excluded from the study', 'acute HF patients with reduced left ventricular ejection fraction (EF', 'Acute Heart Failure Patients With Reduced Ejection Fraction Without Cardiogenic Shock']",['High Lactate Level'],"['CV death', 'composite of cardiovascular (CV) death and hospitalization for heart failure (HHF', 'blood lactate levels', 'TAPSE ratio', 'low blood lactate levels', 'change in NT-proBNP levels', 'cardiovascular (CV) death and hospitalization for heart failure (HF', 'risk of CV death and HHF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3888927', 'cui_str': 'TAPSE'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",85.0,0.120677,High lactate levels significantly increased the risk of CV death and HHF at 6 months by nearly 5.35-fold in acute HF patients with reduced EF.,"[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Uyar', 'Affiliation': 'Department of Cardiology, Mersin University Medical Faculty, 33343, Mersin, Turkey.'}, {'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Yesil', 'Affiliation': 'Department of Cardiology, Toros State Hospital, Mersin, Turkey.'}, {'ForeName': 'Muzaffer', 'Initials': 'M', 'LastName': 'Karadeniz', 'Affiliation': 'Department of Cardiology, Mersin University Medical Faculty, 33343, Mersin, Turkey.'}, {'ForeName': 'Ozcan', 'Initials': 'O', 'LastName': 'Orscelik', 'Affiliation': 'Department of Cardiology, Mersin University Medical Faculty, 33343, Mersin, Turkey.'}, {'ForeName': 'Bugra', 'Initials': 'B', 'LastName': 'Ozkan', 'Affiliation': 'Department of Cardiology, Mersin University Medical Faculty, 33343, Mersin, Turkey.'}, {'ForeName': 'Turkay', 'Initials': 'T', 'LastName': 'Ozcan', 'Affiliation': 'Department of Cardiology, Mersin University Medical Faculty, 33343, Mersin, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Cicek Yilmaz', 'Affiliation': 'Department of Cardiology, Mersin University Medical Faculty, 33343, Mersin, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Celik', 'Affiliation': 'Department of Cardiology, Mersin University Medical Faculty, 33343, Mersin, Turkey. ahmetcelik39@hotmail.com.'}]",Cardiovascular toxicology,['10.1007/s12012-020-09563-9']
3721,32045951,Heart Rate During an Exercise Test and Acute High-intensity Interval Training in Type 2 Diabetes.,"To describe and compare the acute heart rate changes during an incremental exercise test and high-intensity interval training (HIIT) in subjects of different glucose control. Seventy-five adults were allocated into three groups: Normoglycaemic (NG, n= 32), Pre- (PreT2D, n= 30) and Type 2 diabetic (T2D, n= 13) subjects. Subjects performed an incremental cycling test to determine cardiorespiratory fitness (VO 2 max), maximum heart rate (HRmax) and HR recovery post maximal effort, as well as a HIIT cycling session. HR variations are reported as HR pre (HR-pre INT ), and post interval (HR-post INT ), percentage of maximum HR (%HRmax), delta of HR increased (∆HR INT ), and delta HR recovery after each interval (∆HRR). By groups, there was a significant difference for the %HRmax in 1 st and 2 nd , but not in intervals 3 rd to 10 th between Pre-T2D and T2D groups. There were significant differences for the %HRmax in 1 st to 2 nd intervals between Pre-T2D and T2D groups. Significant ( P< 0.05) differences at some intervals were found for ΔHR INT , and ΔHRR. These findings suggest that the HR during an incremental exercise test, and from a typical 10-intervals based HIIT protocol could be used as an intensity marker for individuals independent of their glycaemic control.",2020,"Significant ( P< 0.05) differences at some intervals were found for ΔHR INT , and ΔHRR.","['Type 2 Diabetes', 'Seventy-five adults', 'subjects of different glucose control', 'PreT2D, n= 30) and Type 2 diabetic (T2D, n= 13) subjects']","['Pre', 'incremental exercise test and high-intensity interval training (HIIT', 'Interval Training']","['Heart Rate', 'HR pre (HR-pre INT ), and post interval (HR-post INT ), percentage of maximum HR (%HRmax), delta of HR increased (∆HR INT ), and delta HR recovery', 'Acute High-intensity', 'cardiorespiratory fitness (VO 2 max), maximum heart rate (HRmax) and HR recovery post maximal effort, as well as a HIIT cycling session']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",75.0,0.023136,"Significant ( P< 0.05) differences at some intervals were found for ΔHR INT , and ΔHRR.","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Andrade-Mayorga', 'Affiliation': 'Department of Preclinical Sciences, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Mancilla', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Department of Human Movement Science, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Díaz', 'Affiliation': 'Physical Education, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Quality of Life and Wellness Research Group, Department of Physical Activity Sciences, Laboratory of Human Performance, Universidad de Los Lagos, Chile.'}]",International journal of sports medicine,['10.1055/a-1015-0591']
3722,31805012,Oral N-acetylcysteine improves cone function in retinitis pigmentosa patients in phase I trial.,"BACKGROUNDIn retinitis pigmentosa (RP), rod photoreceptors degenerate from 1 of many mutations, after which cones are compromised by oxidative stress. N-acetylcysteine (NAC) reduces oxidative damage and increases cone function/survival in RP models. We tested the safety, tolerability, and visual function effects of oral NAC in RP patients.METHODSSubjects (n = 10 per cohort) received 600 mg (cohort 1), 1200 mg (cohort 2), or 1800 mg (cohort 3) NAC bid for 12 weeks and then tid for 12 weeks. Best-corrected visual acuity (BCVA), macular sensitivity, ellipsoid zone (EZ) width, and aqueous NAC were measured. Linear mixed-effects models were used to estimate the rates of changes during the treatment period.RESULTSThere were 9 drug-related gastrointestinal adverse events that resolved spontaneously or with dose reduction (maximum tolerated dose 1800 mg bid). During the 24-week treatment period, mean BCVA significantly improved at 0.4 (95% CI: 0.2-0.6, P < 0.001), 0.5 (95% CI: 0.3-0.7, P < 0.001), and 0.2 (95% CI: 0.02-0.4, P = 0.03) letters/month in cohorts 1, 2, and 3, respectively. There was no significant improvement in mean sensitivity over time in cohorts 1 and 2, but there was in cohort 3 (0.15 dB/month, 95% CI: 0.04-0.26). There was no significant change in mean EZ width in any cohort.CONCLUSIONOral NAC is safe and well tolerated in patients with moderately advanced RP and may improve suboptimally functioning macular cones. A randomized, placebo-controlled trial is needed to determine if oral NAC can provide long-term stabilization and/or improvement in visual function in patients with RP.TRIAL REGISTRATIONNCT03063021.FUNDINGMr. and Mrs. Robert Wallace, Mr. and Mrs. Jonathan Wallace, Rami and Eitan Armon, Marc Sumerlin, Cassandra Hanley, and Nacuity Pharmaceuticals, Inc.",2020,RESULTSThere were 9 drug-related gastrointestinal adverse events that resolved spontaneously or with dose reduction (maximum tolerated dose 1800 mg bid).,"['retinitis pigmentosa (RP', 'RP patients', 'patients with moderately advanced RP', 'patients with RP.TRIAL REGISTRATIONNCT03063021.FUNDINGMr', 'retinitis pigmentosa patients']","['Oral N-acetylcysteine', 'placebo', 'oral NAC', 'NAC', 'N-acetylcysteine (NAC']","['gastrointestinal adverse events', 'mean sensitivity', 'cone function', 'visual function', 'Best-corrected visual acuity (BCVA), macular sensitivity, ellipsoid zone (EZ) width, and aqueous NAC', 'mean BCVA', 'safety, tolerability, and visual function effects', 'mean EZ width', 'safe and well tolerated']","[{'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0393983', 'cui_str': 'Cerebellar Herniation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.250889,RESULTSThere were 9 drug-related gastrointestinal adverse events that resolved spontaneously or with dose reduction (maximum tolerated dose 1800 mg bid).,"[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Campochiaro', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Iftikhar', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Gulnar', 'Initials': 'G', 'LastName': 'Hafiz', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Akhlaq', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Tsai', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Wehling', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Wall', 'Affiliation': 'Nacuity Pharmaceuticals, Inc., Fort Worth, Texas, USA.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Singh', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Xiangrong', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': 'Wilmer Eye Institute and.'}]",The Journal of clinical investigation,['10.1172/JCI132990']
3723,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3724,32057627,Effects of Extremity Massage on Preoperative Anxiety: A Three-Arm Randomized Controlled Clinical Trial on Phacoemulsification Candidates.,"PURPOSE
The present study aimed to compare the effects of foot and hand massage on preoperative anxiety.
DESIGN
Three-arm randomized, nonblinded, placebo-controlled, parallel group trial.
METHODS
This study was conducted on 90 female candidates waiting for phacoemulsification cataract surgery in Arak Amirkabir Hospital, Iran. Patients were consecutively selected and randomly divided into three groups of hand (n = 30), foot (n = 30), and placebo (n = 30), using a random number generator software program. In each group, massage was performed 5 minutes for each hand or foot in the surgical waiting room about 10 minutes before surgery. Anxiety was measured before and after the intervention by visual analog scale and also assessing physiological indicators (heart rate, respiratory rate, systolic and diastolic blood pressures).
FINDINGS
All the 90 patients completed the study and were included in the final analysis. Both hand and foot massage resulted in a significant decrease compared with placebo massage in anxiety and heart rate. However, no significant difference was found between hand and foot massage in any of the measured parameters. In the foot group and hand group, a significant reduction was observed in heart rate and anxiety after the intervention, whereas the anxiety increased significantly in the placebo group after the intervention. Moreover, systolic blood pressure in the foot group and the respiratory rate in the hand group significantly decreased after the intervention.
CONCLUSIONS
Application of hand or foot massage seems to be effective in managing anxiety in patients waiting for phacoemulsification cataract surgery.",2020,"In the foot group and hand group, a significant reduction was observed in heart rate and anxiety after the intervention, whereas the anxiety increased significantly in the placebo group after the intervention.","['90 patients completed the study and were included in the final analysis', '90 female candidates waiting for phacoemulsification cataract surgery in Arak Amirkabir Hospital, Iran', 'patients waiting for phacoemulsification cataract surgery']","['foot and hand massage', 'placebo', 'Phacoemulsification Candidates', 'placebo massage', 'Extremity Massage']","['Anxiety', 'systolic blood pressure', 'anxiety', 'Preoperative Anxiety', 'visual analog scale and also assessing physiological indicators (heart rate, respiratory rate, systolic and diastolic blood pressures', 'respiratory rate', 'anxiety and heart rate', 'heart rate and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for (contextual qualifier) (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",90.0,0.0485843,"In the foot group and hand group, a significant reduction was observed in heart rate and anxiety after the intervention, whereas the anxiety increased significantly in the placebo group after the intervention.","[{'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Farmahini Farahani', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Noruzi Zamenjani', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Operating Room Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Shamsikhani', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Purfarzad', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran. Electronic address: m.harorani@yahoo.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.10.010']
3725,32047601,Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial.,"Background: A randomized clinical trial was conducted to compare the postoperative pain following endodontic treatment of necrotic teeth with apical periodontitis. Treatments were performed in multiple visits with application of triple antibiotic paste interappointment dressing or single visit without interappointment dressing. Methods: In total 44 participants were assigned randomly into two groups. Group A: multiple visit endodontic treatment with triple antibiotic paste interappointment dressing; group B: single visit endodontic treatment without interappointment dressing. Postoperative pain of participants was assessed after 24, 48, 72 hours and one week using numerical rating scale. Results: No statistically significant difference was found in postoperative pain after 24, 48, 72 hours and one week between the two groups. Conclusion: Triple antibiotic paste as an interappointment dressing in multiple visits endodontic treatment was not proved to reduce the postoperative pain compared to a single visit in patients with necrotic teeth with apical periodontitis who did not have an interappointment dressing. Trial registration: clinicaltrials.gov, NCT02947763. Date: 28th October 2016.",2019,"No statistically significant difference was found in postoperative pain after 24, 48, 72 hours and one week between the two groups. ","['necrotic teeth with apical periodontitis', 'In total 44 participants', 'patients with necrotic teeth with apical periodontitis who did not have an interappointment dressing', 'patients with necrotic teeth with apical periodontitis']","['triple antibiotic paste interappointment dressing or single visit without interappointment dressing', 'triple antibiotic paste interappointment dressing; group B: single visit endodontic treatment without interappointment dressing', 'single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste', 'Triple antibiotic paste']","['postoperative pain', 'Postoperative pain']","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",44.0,0.229787,"No statistically significant difference was found in postoperative pain after 24, 48, 72 hours and one week between the two groups. ","[{'ForeName': 'Safeya', 'Initials': 'S', 'LastName': 'AbdurRahman', 'Affiliation': 'Department of Endodontics, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Saied M', 'Initials': 'SM', 'LastName': 'Abdel Aziz', 'Affiliation': 'Department of Endodontics, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Shaimaa I', 'Initials': 'SI', 'LastName': 'Gawdat', 'Affiliation': 'Department of Endodontics, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'AbdalSamad', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, Cairo University, Cairo, Egypt.'}]",F1000Research,['10.12688/f1000research.19936.1']
3726,32055822,A Neurofunctional Domains Approach to Evaluate D1/D5 Dopamine Receptor Partial Agonism on Cognition and Motivation in Healthy Volunteers With Low Working Memory Capacity.,"BACKGROUND
Dopamine D1 receptor signaling plays key roles in core domains of neural function, including cognition and reward processing; however, many questions remain about the functions of circuits modulated by dopamine D1 receptor, largely because clinically viable, selective agonists have yet to be tested in humans.
METHODS
Using a novel, exploratory neurofunctional domains study design, we assessed the safety, tolerability, pharmacodynamics, and pharmacokinetics of PF-06412562, a selective D1/D5R partial agonist, in healthy male volunteers who met prespecified criteria for low working memory capacity. Functional magnetic resonance imaging, electrophysiologic endpoints, and behavioral paradigms were used to assess working memory, executive function, and motivation/reward processing following multiple-dose administration of PF-06412562. A total of 77 patients were assigned PF-06412562 (3 mg twice daily and 15 mg twice daily) or placebo administered for 5 to 7 days. Due to the exploratory nature of the study, it was neither powered for any specific treatment effect nor corrected for multiple comparisons.
RESULTS
Nominally significant improvements from baseline in cognitive endpoints were observed in all 3 groups; however, improvements in PF-06412562-treated patients were less than in placebo-treated participants. Motivation/reward processing endpoints were variable. PF-06412562 was safe and well tolerated, with no serious adverse events, severe adverse events, or adverse events leading to dose reduction or temporary discontinuation except for 1 permanent discontinuation due to increased orthostatic heart rate.
CONCLUSIONS
PF-06412562, in the dose range and patient population explored in this study, did not improve cognitive function or motivation/reward processing more than placebo over the 5- to 7-day treatment period.
CLINICALTRIALS.GOV IDENTIFIER
NCT02306876.",2020,"PF-06412562 was safe and well tolerated, with no serious adverse events (AEs), severe AEs, or AEs leading to dose reduction or temporary discontinuation, except for 1 permanent discontinuation due to increased orthostatic heart rate.
","['Healthy Volunteers With Low Working Memory Capacity', '77 subjects', 'healthy male volunteers who met pre-specified criteria for low working memory capacity']","['placebo', 'D1/D5 Dopamine Receptor Partial Agonism', 'PF-06412562']","['cognitive endpoints', 'Cognition and Motivation', 'safety, tolerability, pharmacodynamics, and pharmacokinetics of PF-06412562', 'Motivation/reward processing endpoints', 'safe and well tolerated, with no serious adverse events (AEs), severe AEs, or AEs leading to dose reduction or temporary discontinuation', 'cognitive function or motivation/reward processing', 'working memory, executive function, and motivation/reward processing', 'orthostatic heart rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034798', 'cui_str': 'Dopamine Receptor'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",77.0,0.252281,"PF-06412562 was safe and well tolerated, with no serious adverse events (AEs), severe AEs, or AEs leading to dose reduction or temporary discontinuation, except for 1 permanent discontinuation due to increased orthostatic heart rate.
","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Balice-Gordon', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Garry D', 'Initials': 'GD', 'LastName': 'Honey', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chatham', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Estibaliz', 'Initials': 'E', 'LastName': 'Arce', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Duvvuri', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Melissa Graham', 'Initials': 'MG', 'LastName': 'Naylor', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Wenlei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'DeMartinis', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Harel', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Gabriel H', 'Initials': 'GH', 'LastName': 'Braley', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Rouba', 'Initials': 'R', 'LastName': 'Kozak', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}, {'ForeName': 'Lovingly', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'California Clinical Trials Medical Group/PAREXEL International, Glendale, CA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Gray', 'Affiliation': 'Pfizer Worldwide Research and Development, Cambridge, MA.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa007']
3727,31362530,Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial.,"BACKGROUND
Metformin is first-line therapy for type 2 diabetes mellitus, although its effects on the cardiovascular system are unproved.
METHODS
In this post hoc analysis, patients in SAVOR-TIMI 53 (Saxagliptin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus) with baseline biomarker samples (n=12 156) were classified as ever versus never taking metformin during the trial period. Associations between metformin exposure and outcomes were estimated with inverse probability of treatment weighting Cox modeling for the composite end point of cardiovascular death, myocardial infarction, or ischemic stroke, as well as cardiovascular death and all-cause mortality, with biomarkers included as covariates. Additional sensitivity analyses included propensity score matching and Cox multivariable models.
RESULTS
Of the 12 156 patients with baseline biomarker samples, 8971 (74%) had metformin exposure, 1611 (13%) had prior heart failure, and 1332 (11%) had at least moderate chronic kidney disease (estimated glomerular filtration rate ≤45 mL·min -1 ·1.73 m -2 ). Metformin use was associated with no difference in risk for the composite end point (hazard ratio for inverse probability of treatment weighting, 0.92 [95% CI, 0.76-1.11]) but lower risk of all-cause mortality (hazard ratio for inverse probability of treatment weighting, 0.75 [95% CI, 0.59-0.95]). There was no significant relationship between metformin use and these end points in patients with prior heart failure or moderate to severe chronic kidney disease.
CONCLUSIONS
In a cohort of 12 156 patients with type 2 diabetes mellitus and high cardiovascular risk, metformin use was associated with lower rates of all-cause mortality, including after adjustment for clinical variables and biomarkers, but not lower rates of the composite end point of cardiovascular death, myocardial infarction, or ischemic stroke. This association was most apparent in patients without prior heart failure or moderate to severe chronic kidney disease.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01107886.",2019,"Metformin use was associated with no difference in risk for the composite end point (HRIPTW 0.92; 95% CI 0.76-1.11), but lower risk of all-cause mortality (HR IPTW 0.75; 95% CI 0.59-0.95).","['12,156 patients with baseline biomarker samples, 8,971 (74%) had metformin exposure, 1,611 (13%) had prior HF, and 1,332 (11', 'patients without prior HF or moderate to severe CKD', 'Patients with Diabetes with or without Heart Failure or Kidney Dysfunction', 'type 2 diabetes mellitus (T2DM', 'patients in SAVOR-TIMI 53 with baseline biomarker samples (n=12,156) were classified as Ever versus Never taking', '12,156 patients with T2DM and high CV risk']","['Metformin', 'metformin']","['CV death, myocardial infarction (MI), or ischemic stroke as well as CV death', 'CV death, MI, or ischemic stroke', 'inverse probability of treatment weighting (IPTW']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function (finding)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.085248,"Metformin use was associated with no difference in risk for the composite end point (HRIPTW 0.92; 95% CI 0.76-1.11), but lower risk of all-cause mortality (HR IPTW 0.75; 95% CI 0.59-0.95).","[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Clinical Trials), Département Hospitalo-Universitaire FIRE (Fibrosis, Inflammation, Remodelling), Université de Paris, Sorbonne Paris-Cité, France (P.G.S.).'}, {'ForeName': 'KyungAh', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Estella', 'Initials': 'E', 'LastName': 'Kanevsky', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.040144']
3728,32049573,Total versus subtotal tonsillectomy for recurrent tonsillitis - a prospective randomized noninferiority clinical trial.,"Background: For many years experts have called for randomized controlled trials to resolve the question whether tonsillectomy, which is associated with significant comorbidity, can be replaced by partial tonsillectomy in patients with recurrent tonsillitis. Objective: To find out whether subtotal tonsillectomy is a suitable therapeutic alternative to total tonsillectomy in adult patients with recurrent episodes of acute tonsillitis. Material and methods: Study design - Single-blind prospective non-inferiority randomized clinical trial with intraindividual design. Setting - 80 patients were recruited at a tertiary referral center. Subjects - Adult patients with recurrent tonsillitis received total tonsillectomy on one side and subtotal tonsillectomy on the other side after randomization. Main outcome measure was frequency of postoperative tonsillitis on the side of subtotal tonsillectomy and postoperative pharyngitis in the former tonsil area on the side of total tonsillectomy. The study was registered in the German Clinical Trials Register (DRKS-ID: DRKS00015628). Results: Within 12 months none of the subjects suffered from recurrent tonsillitis after subtotal tonsillectomy. Subtotal tonsillectomy caused less pain than total tonsillectomy. Conclusion: Subtotal tonsillectomy might be an alternative treatment option associated with lower morbidity than total tonsillectomy in adults with recurrent tonsillitis.",2020,Subtotal tonsillectomy might be an alternative treatment option associated with lower morbidity than total tonsillectomy in adults with recurrent tonsillitis.,"['Subjects - Adult patients with recurrent tonsillitis', ' 80 patients were recruited at a tertiary referral center', 'adult patients with recurrent episodes of acute tonsillitis', 'adults with recurrent tonsillitis', 'patients with recurrent tonsillitis']","['subtotal tonsillectomy', 'Subtotal tonsillectomy', 'total tonsillectomy on one side and subtotal tonsillectomy']","['frequency of postoperative tonsillitis on the side of subtotal tonsillectomy and postoperative pharyngitis in the former tonsil area on the side of total tonsillectomy', 'recurrent tonsillitis', 'pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040425', 'cui_str': 'Tonsillitis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0443287', 'cui_str': 'Recurrent episode (qualifier value)'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis (disorder)'}]","[{'cui': 'C0728939', 'cui_str': 'Subtotal (qualifier value)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040425', 'cui_str': 'Tonsillitis'}, {'cui': 'C0728939', 'cui_str': 'Subtotal (qualifier value)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0040421', 'cui_str': 'Tonsil'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",80.0,0.0594954,Subtotal tonsillectomy might be an alternative treatment option associated with lower morbidity than total tonsillectomy in adults with recurrent tonsillitis.,"[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Kisser', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Clinic Halle, Halle, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lill', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Evangelical Hospital, Vienna, Austria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Adderson-Kisser', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Clinic Halle, Halle, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Patscheider', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University of Munich, Munich, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Stelter', 'Affiliation': 'ENT, Head and Neck Surgery, ENT Center Mangfall-Inn, Rosenheim, Germany.'}]",Acta oto-laryngologica,['10.1080/00016489.2020.1725112']
3729,32055820,"Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA)-a randomized, controlled crossover trial indicating effects on disease activity.","BACKGROUND
Many patients with rheumatoid arthritis (RA) report symptom relief from certain foods. Earlier research indicates positive effects of food and food components on clinical outcomes in RA, but insufficient evidence exists to provide specific dietary advice. Food components may interact but studies evaluating combined effects are lacking.
OBJECTIVES
We aimed to investigate if an anti-inflammatory diet reduces disease activity in patients with RA.
METHODS
In this single-blinded crossover trial, 50 patients with RA were randomly assigned to an intervention diet containing a portfolio of suggested anti-inflammatory foods, or a control diet similar to the general dietary intake in Sweden, for 10 wk. After a 4-mo washout period the participants switched diet. Food equivalent to ∼50% of energy requirements was delivered weekly to their homes. For the remaining meals, they were encouraged to consume the same type of foods as the ones provided during each diet. Primary outcome was change in Disease Activity Score in 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR). Secondary outcomes were changes in the components of DAS28-ESR (tender and swollen joints, ESR, and visual analog scale for general health) and DAS28-C-reactive protein.
RESULTS
In the main analysis, a linear mixed ANCOVA model including the 47 participants completing ≥1 diet period, there was no significant difference in DAS28-ESR between the intervention and control periods (P = 0.116). However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test). No significant differences in the components were observed.
CONCLUSIONS
This trial indicates positive effects of a proposed anti-inflammatory diet on disease activity in patients with RA. Additional studies are required to determine if this diet can cause clinically relevant improvements.This trial was registered at clinicaltrials.gov as NCT02941055.",2020,"However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test).","['50 patients with RA', 'Rheumatoid Arthritis', 'patients with rheumatoid arthritis (RA', 'patients with RA']","['intervention diet containing a portfolio of suggested anti-inflammatory foods, or a control diet similar to the general dietary intake in Sweden, for 10 wk', 'anti-inflammatory diet', 'Anti-inflammatory Diet']","['DAS28-ESR', 'components of DAS28-ESR (tender and swollen joints, ESR, and visual analog scale for general health) and DAS28-C-reactive protein', 'disease activity', 'change in Disease Activity Score in 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}]",50.0,0.133574,"However, in unadjusted analyses, DAS28-ESR significantly decreased during the intervention period and was significantly lower after the intervention than after the control period in the participants who completed both periods (n = 44; median: 3.05; IQR: 2.41, 3.79 compared with median: 3.27; IQR: 2.69, 4.28; P = 0.04, Wilcoxon's Signed Rank test).","[{'ForeName': 'Anna K E', 'Initials': 'AKE', 'LastName': 'Vadell', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Bärebring', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hulander', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Gjertsson', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Lindqvist', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Winkvist', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa019']
3730,31197508,Effects of photobiomodulation on muscle strength in post-menopausal women submitted to a resistance training program.,"The aim of this study was to compare the effects of resistance training of low volume and high intensity with or without photobiomodulation (PBM) on muscle strength and functional performance in post-menopausal women. Thirty-four post-menopausal women were randomized into resistance training (RTG, n = 17) or resistance training plus PBM (PBMG, n = 17). Individuals from both groups received the same RT protocol consisting of leg-press 45°, front lat pulldown, leg curl, chest press, and squat performed in two sets of 10 repetitions with a workload of 75% of one repetition maximum (1RM), twice per week, during 8 weeks. PBMG individuals also received, prior to the exercise session, PBM through a cluster containing 7 visible diodes (630 nm) and 7 infrared diodes (850 nm) with power of 100 mW each and energy of 4 J per diode, applied to the quadriceps femoris muscle; individuals from RTG received placebo PBM prior to the sessions, applied with the same device switched off. Muscle strength (1RM; isometric dynamometer), functional performance (Time Up and Go; Berg Balance Scale; 6-min walk test), and quality of life (World Health Organization Quality of Life-Bref) were performed before and after 8 weeks. Both groups increased muscle strength (p < 0.001) for all exercises, without group differences (p = 0.651). Quality of life (p = 0.015) and balance (p = 0.006) increased only in the RTG. The results suggest that PBM were not able for inducing additional benefits to RT to improve muscle strength in post-menopausal women.",2020,Quality of life (p = 0.015) and balance (p = 0.006) increased only in the RTG.,"['post-menopausal women', 'Thirty-four post-menopausal women', 'post-menopausal women submitted to a resistance training program']","['resistance training of low volume and high intensity with or without photobiomodulation (PBM', 'same RT protocol consisting of leg-press 45°, front lat pulldown, leg curl, chest press, and squat performed in two sets of 10 repetitions with a workload of 75% of one repetition maximum (1RM', 'resistance training (RTG, n\u2009=\u200917) or resistance training plus PBM (PBMG, n\u2009=\u200917', 'placebo PBM', 'photobiomodulation']","['Quality of life', 'muscle strength and functional performance', 'muscle strength', 'Muscle strength (1RM; isometric dynamometer), functional performance (Time Up and Go; Berg Balance Scale; 6-min walk test), and quality of life (World Health Organization Quality of Life-Bref']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0023979', 'cui_str': 'LATS'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034380'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3853978'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]",,0.0192002,Quality of life (p = 0.015) and balance (p = 0.006) increased only in the RTG.,"[{'ForeName': 'Johny N', 'Initials': 'JN', 'LastName': 'Almeida', 'Affiliation': 'Health Science Graduation Program, Federal University of São Paulo, Santos, Brazil. johny.almeida09@gmail.com.'}, {'ForeName': 'Wagner L', 'Initials': 'WL', 'LastName': 'Prado', 'Affiliation': 'Department of Human Movement Science, Federal University of São Paulo, Silva Jardim, 136, Santos, São Paulo, 11015-020, Brazil.'}, {'ForeName': 'Caio M', 'Initials': 'CM', 'LastName': 'Terra', 'Affiliation': 'Health Science Graduation Program, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Matheus G', 'Initials': 'MG', 'LastName': 'Oliveira', 'Affiliation': 'Health Science Graduation Program, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Renato A', 'Initials': 'RA', 'LastName': 'Garcia', 'Affiliation': 'Health Science Graduation Program, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Pinfildi', 'Affiliation': 'Department of Human Movement Science, Federal University of São Paulo, Silva Jardim, 136, Santos, São Paulo, 11015-020, Brazil.'}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Botero', 'Affiliation': 'Department of Human Movement Science, Federal University of São Paulo, Silva Jardim, 136, Santos, São Paulo, 11015-020, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02822-4']
3731,31203569,Acute effect of photobiomodulation using light-emitting diodes (LEDs) on baroreflex sensitivity during and after constant loading exercise in patients with type 2 diabetes mellitus.,"To evaluate the photobiomodulation (PBM) effect on the cardiovascular autonomic control, analyzed by baroreflex sensitivity (sequence method), during constant load exercise and recovery in diabetic men, we evaluated 11 men with type 2 diabetes (DM2) (40-64 years). The constant workload exercise protocol (TECC) was performed on two different days, 14 days apart from each other, to guarantee PBM washout period. After PBM by light-emitting diode (LED) irradiation (150 J or 300 J or placebo), 10 min of rest (REST) was performed. After this period, the volunteer was positioned on a cycloergometer to start the test (1-min rest, 3-min free-load heating, 6-min constant workload-EXERCISE, 6-min free-load cool-down, 1-min rest) followed by a sitting period of 10 min (RECOVERY). The constant workload corresponded to 80%VO 2GET (gas exchange threshold) identified by a previous cardiopulmonary exercise test (CPET). PBM was applied in continuous mode, contact technique, bilaterally, on both femoral quadriceps and gastrocnemius muscle groups. The electrocardiogram R-R intervals (BioAmp FE132) and the peripheral pulse pressure signals (Finometer PRO) were collected continuously throughout the protocol. Stable sequences of 256 points were chosen at REST, EXERCISE, and RECOVERY. The baroreflex sensitivity (BRS) was computed in time domain according to the sequence method (α seq ). The comparison between therapies (150 J/300 J/placebo) and condition (REST, EXERCISE, and RECOVERY) was performed using the ANOVA two-way repeated measures test. There was no interaction between therapy and conditions during the TECC. There was only the condition effect (p < 0.001), showing that the behavior of α seq was similar regardless of the therapy. Photobiomodulation with 150 J or 300 J applied previously to a moderate-intensity TECC in DM2 was not able to promote cardiovascular autonomic control changes leading to an improvement in BRS.",2020,"There was only the condition effect (p < 0.001), showing that the behavior of α seq was similar regardless of the therapy.","['diabetic men, we evaluated 11 men with type 2 diabetes (DM2) (40-64\xa0years', 'patients with type 2 diabetes mellitus']","['photobiomodulation using light-emitting diodes (LEDs', 'PBM', 'light-emitting diode (LED) irradiation (150\xa0J or 300\xa0J or placebo', 'constant workload exercise protocol (TECC', 'constant loading exercise']","['condition effect', 'baroreflex sensitivity (BRS', 'electrocardiogram R-R intervals (BioAmp FE132) and the peripheral pulse pressure signals (Finometer PRO', 'baroreflex sensitivity']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0232139', 'cui_str': 'Peripheral pulse'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",11.0,0.0241843,"There was only the condition effect (p < 0.001), showing that the behavior of α seq was similar regardless of the therapy.","[{'ForeName': 'Juliana Cristina', 'Initials': 'JC', 'LastName': 'Milan-Mattos', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, Brazil. julianacristinamilan@gmail.com.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'de Oliveira Francisco', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Amanda Magdalena', 'Initials': 'AM', 'LastName': 'Ferroli-Fabrício', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Minatel', 'Affiliation': 'Tiradentes University Center, Maceió, Alagoas, Brazil.'}, {'ForeName': 'Ana Carolina Aparecida', 'Initials': 'ACA', 'LastName': 'Marcondes', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Porta', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Beltrame', 'Affiliation': 'Computing Institute, Campinas State University, Campinas, Brazil.'}, {'ForeName': 'Nivaldo Antônio', 'Initials': 'NA', 'LastName': 'Parizotto', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Cleber', 'Initials': 'C', 'LastName': 'Ferraresi', 'Affiliation': 'Post-Graduation Program in Biomedical Engineering, Universidade Brasil, São Paulo, Brazil.'}, {'ForeName': 'Vanderlei Salvador', 'Initials': 'VS', 'LastName': 'Bagnato', 'Affiliation': 'Department of Physics, São Paulo University, São Carlos, Brazil.'}, {'ForeName': 'Aparecida Maria', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, São Carlos, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02815-3']
3732,31924322,Comparison of the Effect of Age (< 75 Versus ≥ 75) on the Efficacy and Safety of Dual Therapy (Dabigatran + Clopidogrel or Ticagrelor) Versus Triple Therapy (Warfarin + Aspirin + Clopidogrel or Ticagrelor) in Patients With Atrial Fibrillation After Percutaneous Coronary Intervention (from the RE-DUAL PCI Trial).,"The RE-DUAL PCI trial reported that dabigatran dual therapy (110/150 mg twice daily, plus clopidogrel or ticagrelor) reduced bleeding events versus warfarin triple therapy (warfarin plus aspirin and clopidogrel or ticagrelor) in patients with atrial fibrillation who underwent percutaneous coronary intervention, with noninferiority in composite thromboembolic events. In this prespecified analysis, risks of first major or clinically relevant nonmajor bleeding event and composite end point of death, thromboembolic events, or unplanned revascularization were compared between dabigatran dual therapy and warfarin triple therapy in older (≥ 75 years) and younger (< 75 years) patients, using Cox proportional hazard regression. Of 2,725 patients randomized to treatment, 1,026 (37.7%) were categorized into older and 1,699 (62.3%) into younger age groups. Dabigatran 110 mg dual therapy lowered bleeding risk versus warfarin triple therapy in older (hazard ratio [HR] 0.67; 95% confidence interval [CI] 0.51 to 0.89) and younger patients (HR 0.40; 95% CI 0.30 to 0.54); interaction p value: 0.0125. Dabigatran 150 mg dual therapy lowered bleeding risk versus warfarin triple therapy in younger patients (HR 0.57; 95% CI 0.44 to 0.74), whereas no benefit could be observed in older patients (HR 1.21; 95% CI 0.83 to 1.77); interaction p value: 0.0013. For the thromboembolic end point, there was a trend for a higher risk with dabigatran 110 mg dual therapy in older patients, compared with warfarin triple therapy, whereas the risk was similar in younger patients. For dabigatran 150 mg dual therapy, the thromboembolic risk versus warfarin triple therapy was similar in older and younger patients. In conclusion, the benefits of dabigatran dual therapy differed in the 2 age groups, which may help dose selection when using dabigatran dual therapy.",2020,"For dabigatran 150 mg dual therapy, the thromboembolic risk versus warfarin triple therapy was similar in older and younger patients.","['older patients', 'older and younger patients', '2,725 patients randomized to treatment, 1,026 (37.7%) were categorized into older and 1,699 (62.3%) into younger age groups', 'patients with atrial fibrillation who underwent percutaneous coronary intervention, with noninferiority in composite thromboembolic events', 'Patients With Atrial Fibrillation']","['Percutaneous Coronary Intervention', 'Triple Therapy (Warfarin\u202f+\u202fAspirin\u202f+\u202fClopidogrel or Ticagrelor', 'clopidogrel or ticagrelor', 'Dual Therapy (Dabigatran\u202f+\u202fClopidogrel or Ticagrelor', 'Dabigatran', 'warfarin triple therapy (warfarin plus aspirin and clopidogrel or ticagrelor', 'warfarin triple therapy']","['thromboembolic risk', 'Efficacy and Safety', 'risks of first major or clinically relevant nonmajor bleeding event and composite end point of death, thromboembolic events, or unplanned revascularization', 'bleeding risk', 'bleeding events']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",2725.0,0.0428795,"For dabigatran 150 mg dual therapy, the thromboembolic risk versus warfarin triple therapy was similar in older and younger patients.","[{'ForeName': 'Jurrien M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St Antonius Ziekenhuis, Nieuwegein, the Netherlands. Electronic address: jurtenberg@gmail.com.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials (FACT), Hôpital Bichat, Paris, France; Université de Paris, Paris, France; INSERM U-1148, Paris, France; Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'de Veer', 'Affiliation': 'St Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'HMS Analytical Software GmbH, Weimar (Lahn), Germany.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.029']
3733,31353413,"Investigating the Effects of Spacing on Working Memory Training Outcome: A Randomized, Controlled, Multisite Trial in Older Adults.","OBJECTIVE
The majority of the population will experience some cognitive decline with age. Therefore, the development of effective interventions to mitigate age-related decline is critical for older adults' cognitive functioning and their quality of life.
METHODS
In our randomized controlled multisite trial, we target participants' working memory (WM) skills, and in addition, we focus on the intervention's optimal scheduling in order to test whether and how the distribution of training sessions might affect task learning, and ultimately, transfer. Healthy older adults completed an intervention targeting either WM or general knowledge twice per day, once per day, or once every-other-day. Before and after the intervention and 3 months after training completion, participants were tested in a variety of cognitive domains, including those representing functioning in everyday life.
RESULTS
In contrast to our hypotheses, spacing seems to affect learning only minimally. We did observe some transfer effects, especially within the targeted cognitive domain (WM and inhibition/interference), which remained stable at the 3-month follow-up.
DISCUSSION
Our findings have practical implications by showing that the variation in training schedule, at least within the range used here, does not seem to be a crucial element for training benefits.",2020,"We did observe some transfer effects, especially within the targeted cognitive domain (WM and inhibition/interference), which remained stable at the 3-month follow-up.
","['older adults', 'Healthy older adults', ""participants' working memory (WM) skills""]",[],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",[],[],,0.0577707,"We did observe some transfer effects, especially within the targeted cognitive domain (WM and inhibition/interference), which remained stable at the 3-month follow-up.
","[{'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Jaeggi', 'Affiliation': 'School of Education, University of California, Irvine.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Buschkuehl', 'Affiliation': 'MIND Research Institute, Irvine, California.'}, {'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Parlett-Pelleriti', 'Affiliation': 'Schmid College of Science and Technology, Chapman University, Orange, California.'}, {'ForeName': 'Seung Min', 'Initials': 'SM', 'LastName': 'Moon', 'Affiliation': 'School of Education, University of California, Irvine.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kritzmacher', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Reuter-Lorenz', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jonides', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz090']
3734,30654643,Olanzapine Versus Placebo in Adult Outpatients With Anorexia Nervosa: A Randomized Clinical Trial.,"OBJECTIVE
This study evaluated the benefits of olanzapine compared with placebo for adult outpatients with anorexia nervosa.
METHODS
This randomized double-blind placebo-controlled trial of adult outpatients with anorexia nervosa (N=152, 96% of whom were women; the sample's mean body mass index [BMI] was 16.7) was conducted at five sites in North America. Participants were randomly assigned in a 1:1 ratio to receive olanzapine or placebo and were seen weekly for 16 weeks. The primary outcome measures were rate of change in body weight and rate of change in obsessionality, assessed with the Yale-Brown Obsessive Compulsive Scale (YBOCS).
RESULTS
Seventy-five participants were assigned to receive olanzapine and 77 to receive placebo. A statistically significant treatment-by-time interaction was observed, indicating that the increase in BMI over time was greater in the olanzapine group (0.259 [SD=0.051] compared with 0.095 [SD=0.053] per month). There was no significant difference between treatment groups in change in the YBOCS obsessions subscale score over time (-0.325 compared with -0.017 points per month) and there were no significant differences between groups in the frequency of abnormalities on blood tests assessing potential metabolic disturbances.
CONCLUSIONS
This study documented a modest therapeutic effect of olanzapine compared with placebo on weight in adult outpatients with anorexia nervosa, but no significant benefit for psychological symptoms. Nevertheless, the finding on weight is notable, as achieving change in weight is notoriously challenging in this disorder.",2019,"There was no significant difference between treatment groups in change in the YBOCS obsessions subscale score over time (-0.325 compared with -0.017 points per month) and there were no significant differences between groups in the frequency of abnormalities on blood tests assessing potential metabolic disturbances.
","['adult outpatients with anorexia nervosa', 'Seventy-five participants', ""adult outpatients with anorexia nervosa (N=152, 96% of whom were women; the sample's mean body mass index [BMI] was 16.7) was conducted at five sites in North America"", 'Adult Outpatients With Anorexia Nervosa']","['Olanzapine Versus Placebo', 'olanzapine', 'placebo', 'olanzapine or placebo']","['frequency of abnormalities on blood tests assessing potential metabolic disturbances', 'YBOCS obsessions subscale score over time', 'rate of change in body weight and rate of change in obsessionality, assessed with the Yale-Brown Obsessive Compulsive Scale (YBOCS', 'BMI over time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}]",75.0,0.447093,"There was no significant difference between treatment groups in change in the YBOCS obsessions subscale score over time (-0.325 compared with -0.017 points per month) and there were no significant differences between groups in the frequency of abnormalities on blood tests assessing potential metabolic disturbances.
","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Attia', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': 'Steinglass', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Walsh', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'Yuanjia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Schreyer', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wildes', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Yilmaz', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Guarda', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'Allan S', 'Initials': 'AS', 'LastName': 'Kaplan', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}, {'ForeName': 'Marsha D', 'Initials': 'MD', 'LastName': 'Marcus', 'Affiliation': 'From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2018.18101125']
3735,31895135,Heparin sensitivity and postoperative blood loss in patients undergoing cardiac surgery with cardiopulmonary bypass.,"BACKGROUND
Heparin-associated coagulation disorder is an important factor related to postoperative bleeding in patients undergoing cardiac surgery with cardiopulmonary bypass. Currently, the relationship between heparin sensitivity and postoperative bleeding is unknown.
OBJECTIVE
To investigate the relationship between individual heparin sensitivity and postoperative blood loss in patients undergoing cardiac surgery.
DESIGN
Prospective controlled study.
SETTING
Tertiary teaching hospital, Urumqi, Xinjiang, PR China. The study was conducted from January 2016 to August 2018.
PATIENTS
A total of 195 adult patients undergoing cardiac valve replacement surgery were included.
INTERVENTION
After initial heparin dosing (2.5 mg kg), patients were divided into three groups according to the whole blood activated clotting time (ACT): group A, insensitive group (ACT < 480 s); group B, sensitive group (480 s < ACT < 750 s); group C, hypersensitive group (ACT > 750 s).
MAIN OUTCOME MEASURES
First, intra-operative and 24-h postoperative blood loss. Second, antithrombin (AT) and factor X mRNA levels. Third, the plasma levels of AT-III and factor X. Fourth, heparin sensitivity index.
RESULTS
Blood loss was approximately 20 to 25% lower in group B than in groups A and C, which was statistically significant (P < 0.01). The AT-III mRNA levels increased from groups A to C and was positively associated with heparin sensitivity; the factor X mRNA levels changed in the opposite direction; a significant difference was observed between groups A and C (P < 0.05). The factor X plasma level showed the same trend as its mRNA. The AT-III plasma level was significantly lower in group B than in groups A and C (P < 0.05).
CONCLUSION
Postoperative blood loss is related to heparin sensitivity in patients undergoing cardiac surgery, and the moderately sensitive patients have the least postoperative bleeding. Individual variation in heparin sensitivity is related to the mRNA and plasma levels of AT-III and factor X.
TRIAL REGISTRATION
Registration number ChiCTR-RPC-17012259.",2020,"The AT-III plasma level was significantly lower in group B than in groups A and C (P < 0.05).
","['Tertiary teaching hospital, Urumqi, Xinjiang, PR China', 'patients undergoing cardiac surgery', '195 adult patients undergoing cardiac valve replacement surgery were included', 'January 2016 to August 2018', 'patients undergoing cardiac surgery with cardiopulmonary bypass']","['whole blood activated clotting time (ACT): group A, insensitive group (ACT\u200a<\u200a480\u200as); group B, sensitive group (480\u200as', 'heparin']","['Heparin sensitivity and postoperative blood loss', 'factor X mRNA levels', 'AT-III plasma level', 'Blood loss', 'plasma levels of AT-III and factor X. Fourth, heparin sensitivity index', 'factor X plasma level', 'intra-operative and 24-h postoperative blood loss', 'AT-III mRNA levels']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0015518', 'cui_str': 'factor X'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",195.0,0.0266553,"The AT-III plasma level was significantly lower in group B than in groups A and C (P < 0.05).
","[{'ForeName': 'Hai-Ping', 'Initials': 'HP', 'LastName': 'Ma', 'Affiliation': 'From the Department of Anesthesiology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, PR China (H-PM, W-FX, JY, JW, HZ).'}, {'ForeName': 'Wei-Fang', 'Initials': 'WF', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001148']
3736,31825499,Effectiveness of a Hospital-Based Computerized Decision Support System on Clinician Recommendations and Patient Outcomes: A Randomized Clinical Trial.,"Importance
Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients.
Objective
To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care.
Design, Setting, and Participants
Open-label, parallel-group, randomized clinical trial among internal medicine wards of a large Italian general hospital. All analyses in this randomized clinical trial followed the intent-to-treat principle. Between November 1, 2015, and December 31, 2016, patients were randomly assigned to the intervention group, in which CDSS-generated reminders were displayed to physicians, or to the control group, in which reminders were generated but not shown. Data were analyzed between February 1 and July 31, 2018.
Interventions
Evidence-Based Medicine Electronic Decision Support (EBMEDS), a commercial CDSS covering a wide array of health conditions across specialties, was integrated into the hospital electronic health records to generate patient-specific recommendations.
Main Outcomes and Measures
The primary outcome was the resolution rate, the rate at which medical problems identified and alerted by the CDSS were addressed by a change in practice. Secondary outcomes included the length of hospital stay and in-hospital all-cause mortality.
Results
In this randomized clinical trial, 20 563 patients were admitted to the hospital. Of these, 6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control). The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men. In total, 28 394 reminders were generated throughout the course of the trial (median, 3 reminders per patient per hospital stay; interquartile range [IQR], 1-6). These messages led to a change in practice in approximately 4 of 100 patients. The resolution rate was 38.0% (95% CI, 37.2%-38.8%) in the intervention group and 33.7% (95% CI, 32.9%-34.4%) in the control group, corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ between the groups, with a median time of 8 days (IQR, 5-13 days) for the intervention group and a median time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not differ between early and late study periods.
Conclusions and Relevance
An international commercial CDSS intervention marginally influenced routine practice in a general hospital, although the change did not statistically significantly affect patient outcomes.
Trial Registration
ClinicalTrials.gov identifier: NCT02577198.",2019,"In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59).","['Clinician Recommendations and Patient Outcomes', '6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control', 'The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men', 'Between November 1, 2015, and December 31, 2016, patients', '20\u202f563 patients were admitted to the hospital']","['Hospital-Based Computerized Decision Support System', 'computerized clinical decision support system (CDSS']","['length of hospital stay and in-hospital all-cause mortality', 'resolution rate', 'length of hospital stay', 'Alert fatigue', 'resolution rate, the rate at which medical problems identified and alerted by the CDSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]",20563.0,0.158738,"In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59).","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Moja', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Polo Friz', 'Affiliation': 'Internal Medicine Division, Medical Department, Vimercate Hospital, Vimercate, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Capobussi', 'Affiliation': 'Clinical Epidemiology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Orthopedic Institute Galeazzi, Milan, Italy.'}, {'ForeName': 'Koren', 'Initials': 'K', 'LastName': 'Kwag', 'Affiliation': 'Medical School of International Health, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Banzi', 'Affiliation': 'IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ruggiero', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Marien', 'Initials': 'M', 'LastName': 'González-Lorenzo', 'Affiliation': 'Humanitas Clinical and Research Center, Milan, Italy.'}, {'ForeName': 'Elisa G', 'Initials': 'EG', 'LastName': 'Liberati', 'Affiliation': 'The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Mangia', 'Affiliation': 'Medilogy Srl, Milan, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nyberg', 'Affiliation': 'Duodecim Medical Publications Ltd, Helsinki, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Kunnamo', 'Affiliation': 'Duodecim Medical Publications Ltd, Helsinki, Finland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cimminiello', 'Affiliation': 'Internal Medicine Division, Medical Department, Vimercate Hospital, Vimercate, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Vighi', 'Affiliation': 'Internal Medicine Division, Medical Department, Vimercate Hospital, Vimercate, Italy.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute and the Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Delgrossi', 'Affiliation': 'Internal Medicine Division, Medical Department, Vimercate Hospital, Vimercate, Italy.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Bonovas', 'Affiliation': 'Humanitas Clinical and Research Center, Milan, Italy.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.17094']
3737,31909902,Six-year experience with treatment of early donor-specific anti-HLA antibodies in pediatric lung transplantation using a human immunoglobulin-based protocol.,"OBJECTIVES
Experience with the treatment of early donor-specific anti-HLA antibodies (eDSA) after lung transplantation in children is very limited. At our institution, we have treated patients with eDSA since 2013 with successive infusions of intravenous human immunoglobulins (IVIG), combined in some cases with a single dose of Rituximab and plasmapheresis (therapeutic plasma exchange [tPE]) or immunoabsorption. The aim of this study was to present the 6-year results of IVIG-based therapy in pediatric lung recipients.
METHODS
Records of pediatric (<18 years old) patients transplanted at our institution between 01/2013 and 03/2019 were reviewed. Outcomes were compared between patients with eDSA treated with IVIG (IVIG group) and without eDSA (control group). Median (interquartile range [IQR]) follow-up amounted to 28 (12-52) months.
RESULTS
During the study period, 66 lung-transplanted pediatric patients were included, of which 27 (41%) formed the IVIG group and 38 (57%) the control group. Among the IVIG patients, 14 (52%) patients showed concomitant graft dysfunction (possible clinical antibody-mediated rejection). The median time to eDSA detection was 24 (14-63) days after transplantation. eDSA were cleared in 25 (96%) of the 26 patients which completed treatment. At 3 years, graft survival (%) was 73 vs 85 (P = .65); freedom (%) from chronic lung allograft rejection (CLAD) was 89 vs 78 (P = .82); and from infection 47 vs 31 (P = .15), in IVIG vs control patients, respectively.
CONCLUSIONS
After lung transplantation, an IVIG-based treatment for eDSA yielded high eDSA clearance. IVIG and control patients showed similar CLAD-free and graft survival.",2020,"At 3 years, graft survival (%) was 73 vs 85 (P = .65); freedom (%) from chronic lung allograft rejection (CLAD) was 89 vs 78 (P = .82); and from infection 47 vs 31 (P = .15), in IVIG vs control patients, respectively.
","['pediatric lung transplantation using a human immunoglobulin-based protocol', '66 lung-transplanted pediatric patients were included, of which 27 (41%) formed the IVIG group and 38 (57%) the control group', 'Records of pediatric (<18 years old) patients transplanted at our institution between 01/2013 and 03/2019 were reviewed', 'pediatric lung recipients']","['intravenous human immunoglobulins (IVIG', 'IVIG-based therapy', 'Rituximab and plasmapheresis (therapeutic plasma exchange [tPE]) or immunoabsorption', 'early donor-specific anti-HLA antibodies (eDSA', 'early donor-specific anti-HLA antibodies']","['CLAD-free and graft survival', 'concomitant graft dysfunction', 'median time to eDSA detection', 'chronic lung allograft rejection (CLAD', 'graft survival', 'eDSA']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0358321', 'cui_str': 'Human immunoglobulin (substance)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0358321', 'cui_str': 'Human immunoglobulin (substance)'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032134', 'cui_str': 'Plasmapheresis'}, {'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0024284', 'cui_str': 'Lymphocytotoxic Antibodies'}]","[{'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1167870', 'cui_str': 'Transplant dysfunction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}]",,0.0278784,"At 3 years, graft survival (%) was 73 vs 85 (P = .65); freedom (%) from chronic lung allograft rejection (CLAD) was 89 vs 78 (P = .82); and from infection 47 vs 31 (P = .15), in IVIG vs control patients, respectively.
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ius', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Clinic for Paediatric Pulmonology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Sommer', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Murielle', 'Initials': 'M', 'LastName': 'Verboom', 'Affiliation': 'Institute of Transfusion Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallensleben', 'Affiliation': 'Institute of Transfusion Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jawad', 'Initials': 'J', 'LastName': 'Salman', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Siemeni', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kühn', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Avsar', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Bobylev', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Poyanmehr', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Erdfelder', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Böthig', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Carlens', 'Affiliation': 'Clinic for Paediatric Pulmonology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Lale', 'Initials': 'L', 'LastName': 'Bayir', 'Affiliation': 'Clinic for Paediatric Pulmonology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Hansen', 'Affiliation': 'Clinic for Paediatric Pulmonology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Blasczyk', 'Affiliation': 'Institute of Transfusion Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Falk', 'Affiliation': 'German Center for Lung Research (DZL/BREATH), Hannover, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Tecklenburg', 'Affiliation': 'Division of Patient Care, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haverich', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Tudorache', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Schwerk', 'Affiliation': 'Clinic for Paediatric Pulmonology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Warnecke', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, Hannover, Germany.'}]",Pediatric pulmonology,['10.1002/ppul.24639']
3738,28950297,A randomized phase II trial of CRLX101 in combination with bevacizumab versus standard of care in patients with advanced renal cell carcinoma.,"Background
Nanoparticle-drug conjugates enhance drug delivery to tumors. Gradual payload release inside cancer cells augments antitumor activity while reducing toxicity. CRLX101 is a novel nanoparticle-drug conjugate containing camptothecin, a potent inhibitor of topoisomerase I and the hypoxia-inducible factors 1α and 2α. In a phase Ib/2 trial, CRLX101 + bevacizumab was well tolerated with encouraging activity in metastatic renal cell carcinoma (mRCC). We conducted a randomized phase II trial comparing CRLX101 + bevacizumab versus standard of care (SOC) in refractory mRCC.
Patients and methods
Patients with mRCC and 2-3 prior lines of therapy were randomized 1 : 1 to CRLX101 + bevacizumab versus SOC, defined as investigator's choice of any approved regimen not previously received. The primary end point was progression-free survival (PFS) by blinded independent radiological review in patients with clear cell mRCC. Secondary end points included overall survival, objective response rate and safety.
Results
In total, 111 patients were randomized and received ≥1 dose of drug (CRLX101 + bevacizumab, 55; SOC, 56). Within the SOC arm, patients received single-agent bevacizumab (19), axitinib (18), everolimus (7), pazopanib (4), sorafenib (4), sunitinib (2), or temsirolimus (2). In the clear cell population, the median PFS on the CRLX101 + bevacizumab and SOC arms was 3.7 months (95% confidence interval, 2.0-4.3) and 3.9 months (95% confidence interval 2.2-5.4), respectively (stratified log-rank P = 0.831). The objective response rate by IRR was 5% with CRLX101 + bevacizumab versus 14% with SOC (Mantel-Haenszel test, P = 0.836). Consistent with previous studies, the CRLX101 + bevacizumab combination was generally well tolerated, and no new safety signal was identified.
Conclusions
Despite promising efficacy data on the earlier phase Ib/2 trial of mRCC, this randomized trial did not demonstrate improvement in PFS for the CRLX101 + bevacizumab combination when compared with approved agents in patients with heavily pretreated clear cell mRCC. Further development in this disease is not planned.
Clinical trial identification
NCT02187302 (NIH).",2017,"In the clear cell population, the median PFS on the CRLX101 + bevacizumab and SOC arms was 3.7 months (95% confidence interval, 2.0-4.3) and 3.9 months (95% confidence interval 2.2-5.4), respectively (stratified log-rank P = 0.831).","['111 patients', 'patients with clear cell', 'patients with heavily pretreated clear cell mRCC', 'metastatic renal cell carcinoma (mRCC', 'patients with advanced renal cell carcinoma', 'Patients and methods\n\n\nPatients with mRCC and 2-3 prior lines of therapy']","['bevacizumab', 'mRCC', 'CRLX101', 'single-agent bevacizumab (19), axitinib (18), everolimus (7), pazopanib (4), sorafenib (4), sunitinib (2), or temsirolimus (2', 'drug (CRLX101\u2009+\u2009bevacizumab', 'CRLX101\u2009+\u2009bevacizumab versus standard of care (SOC', 'CRLX101\u2009+\u2009bevacizumab']","['objective response rate by IRR', 'progression-free survival (PFS', 'overall survival, objective response rate and safety', 'PFS', 'toxicity', 'median PFS']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4048807', 'cui_str': 'CRLX101'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",111.0,0.368381,"In the clear cell population, the median PFS on the CRLX101 + bevacizumab and SOC arms was 3.7 months (95% confidence interval, 2.0-4.3) and 3.9 months (95% confidence interval 2.2-5.4), respectively (stratified log-rank P = 0.831).","[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Voss', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York. Electronic address: mailto:vossm@mskcc.org.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'Department of Medicine, Greenebaum Cancer Center, University of Maryland, Baltimore.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vogelzang', 'Affiliation': 'Department of Hematology/Oncology, Comprehensive Cancer Centers of Nevada, Las Vegas; US Oncology Research, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Keam', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Rha', 'Affiliation': 'Department of Medicine, Severance Hospital, Seoul, Korea.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Vaishampayan', 'Affiliation': 'Department of Oncology, Karmanos Cancer Institute, Detroit.'}, {'ForeName': 'W B', 'Initials': 'WB', 'LastName': 'Harris', 'Affiliation': 'Department of Hematology/Oncology, Emory University Winship Cancer Institute, Atlanta.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Richey', 'Affiliation': 'US Oncology Research, USA; Department of Medicine, Texas Oncology, Fort Worth.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Randall', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Shaffer', 'Affiliation': 'US Oncology Research, USA; Department of Medicine, Albany Medical Center, NYOH, Albany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cohn', 'Affiliation': 'US Oncology Research, USA; Department of Clinical Research, Rocky Mountain Cancer Centers, Denver.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Crowell', 'Affiliation': 'Department of Medicine, Cerulean Pharma Inc., Waltham.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, Cerulean Pharma Inc., Waltham.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Senderowicz', 'Affiliation': 'Department of Medicine, Cerulean Pharma Inc., Waltham.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stone', 'Affiliation': 'Department of Medicine, Cerulean Pharma Inc., Waltham.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Figlin', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Los Angeles.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York.'}, {'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Haas', 'Affiliation': 'Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hutson', 'Affiliation': 'US Oncology Research, USA; Department of Medicine, Texas Oncology, Dallas, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx493']
3739,32028286,10-Day Versus 14-Day Quadruple Concomitant Nonbismuth Therapy for the Treatment of Helicobacter pylori Infection: Results From a Randomized Prospective Study in a High Clarithromycin Resistance Country.,"GOALS
The aim of this study was to investigate the implementation of a 14-day quadruple nonbismuth concomitant regimen, as proposed by recent Guidelines and Consensus Statements.
BACKGROUND
In Greece, a region with >20% clarithromycin resistance where bismuth is unavailable, the 10-day quadruple concomitant scheme has already been adopted as the accepted first-line Helicobacter pylori eradication treatment.
STUDY
Our prospective randomized study included 364 patients with newly diagnosed H. pylori infection, randomized to receive a 10-day or a 14-day nonbismuth quadruple concomitant scheme. Treatment outcome was assessed by C-urea breath test and/or histology at least 4 weeks after therapy. Intention to treat and per protocol analyses of the eradication rates were performed. Secondary endpoints included patient adherence, safety, and the impact of prior antibiotic exposure in treatment efficacy.
RESULTS
The overall eradication rates of the 2 treatments were 87.9% versus 87.4% in the intention to treat analysis, P=1.000, and 93% versus 94.1%, P=0.859, in the per protocol analysis for the 10-day and the 14-day treatment group, respectively. Both groups displayed excellent compliance rates (99.5% for the 10-day vs. 96.2% for the 14-day treatment duration, P=0.067). As regards treatment safety, serious adverse events that led to the discontinuation of both regimens were few, with no statistical difference between the 2 groups (0.5% in the 10-day group and 2.2% in the 14-day group, P>0.05). Previous antibiotic exposure was not significant with regard to treatment efficacy.
CONCLUSION
In Greece, the 10-day concomitant nonbismuth quadruple regimen for first-line treatment remains the most efficient strategy for H. pylori eradication.",2020,"The overall eradication rates of the 2 treatments were 87.9% versus 87.4% in the intention to treat analysis, P=1.000, and 93% versus 94.1%, P=0.859, in the per protocol analysis for the 10-day and the 14-day treatment group, respectively.",['364 patients with newly diagnosed H. pylori infection'],"['10-Day Versus 14-Day Quadruple Concomitant Nonbismuth Therapy', '14-day nonbismuth quadruple concomitant scheme']","['C-urea breath test and/or histology', 'excellent compliance rates', 'patient adherence, safety, and the impact of prior antibiotic exposure in treatment efficacy', 'Helicobacter pylori Infection', 'overall eradication rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0006153', 'cui_str': 'Breath Tests'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1321605', 'cui_str': 'Patient Cooperation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",364.0,0.0386715,"The overall eradication rates of the 2 treatments were 87.9% versus 87.4% in the intention to treat analysis, P=1.000, and 93% versus 94.1%, P=0.859, in the per protocol analysis for the 10-day and the 14-day treatment group, respectively.","[{'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Apostolopoulos', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Ekmektzoglou', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Georgopoulos', 'Affiliation': 'Department of Gastroenterology and Hepatology, Athens Medical, Paleo Faliron Hospital, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Chounta', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Theofanopoulou', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Chrisostomos', 'Initials': 'C', 'LastName': 'Kalantzis', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Erasmia', 'Initials': 'E', 'LastName': 'Vlachou', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Tsibouris', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Alexandrakis', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001328']
3740,32028288,Spontaneous recovery of neuromuscular blockade is an independent risk factor for postoperative pulmonary complications after abdominal surgery: A secondary analysis.,"BACKGROUND
In intermediate-to-high-risk patients, major abdominal surgery is associated with a high incidence of postoperative complications, mainly pulmonary. Neuromuscular blocking drugs have been suggested as a contributing factor, but this remains unproven.
OBJECTIVE
To define the relationship of neuromuscular blockade management (reversal) with postoperative pulmonary complications (PPCs).
DESIGN
The individualised PeRioperative Open-lung approach Versus standard protectivE ventilation in abdominal surgery study was a prospective, multicentre, four-arm, randomised controlled trial. This is a secondary analysis of the data.
SETTING
Twenty-one teaching hospitals in Spain. The study was conducted between 2 January 2015, and 18 May 2016.
PATIENTS
Age more than 18 years with an intermediate-to-high risk for PPCs, scheduled for major abdominal surgery lasting more than 2 h. Exclusion criteria included pregnancy or breastfeeding, and moderate-to-severe organ diseases.
INTERVENTIONS
The mode of reversal of neuromuscular blockade determined two patient groups: pharmacological reversal versus spontaneous recovery.
MAIN OUTCOME MEASURES
The primary outcome was a composite of PPCs during the first 30 postoperative days. The association between categorical variables and PPCs within 30 days was studied. Univariate and multivariable logistic regression modelling and propensity score analyses were performed.
RESULTS
From the 923 patients included, 596 (64.6%) presented with PPCs within 30 days after surgery. Patients who developed these complications were older with a higher BMI, a lower pre-operative SpO2, a higher ASA physical status score and a higher incidence of arterial hypertension, diabetes mellitus or chronic obstructive pulmonary disease. Pharmacological neuromuscular blockade reversal was associated with a lower incidence of PPCs (odds ratio 0.62, 95% CI 0.47 to 0.82).
CONCLUSION
Spontaneous recovery of neuromuscular blockade was an independent risk factor for PPCs in patients with intermediate-to-high risk, undergoing abdominal surgery. We suggest this factor should be included in future studies on PPCs.
TRIAL REGISTRATION
clinicaltrials.gov identifier: NCT02158923.",2020,"Pharmacological neuromuscular blockade reversal was associated with a lower incidence of PPCs (odds ratio 0.62, 95% CI 0.47 to 0.82).
","['Patients who developed these complications were older with a higher BMI', 'Twenty-one teaching hospitals in Spain', 'patients with intermediate-to-high risk, undergoing abdominal surgery', 'Age more than 18 years with an intermediate-to-high risk for PPCs, scheduled for major abdominal surgery lasting more than 2\u200ah. Exclusion criteria included pregnancy or breastfeeding, and moderate-to-severe organ diseases', '923 patients included, 596 (64.6%) presented with PPCs within 30 days after surgery', '2 January 2015, and 18 May 2016']","['neuromuscular blockade management (reversal) with postoperative pulmonary complications (PPCs', 'standard protectivE ventilation']","['ASA physical status score', 'composite of PPCs during the first 30 postoperative days', 'arterial hypertension, diabetes mellitus or chronic obstructive pulmonary disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]",,0.304343,"Pharmacological neuromuscular blockade reversal was associated with a lower incidence of PPCs (odds ratio 0.62, 95% CI 0.47 to 0.82).
","[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Garutti', 'Affiliation': 'From the Department of Anaesthesiology, Hospital General Universitario Gregorio Marañón, Madrid (IG), Department of Anaesthesiology, Consorcio Hospital General Universitario de Valencia (CLE), Department of Anaesthesiology, Hospital de Manises, Valencia (GM), Department of Biostatistics, Hospital General Universitario Gregorio Marañón, Madrid (JMB), Department of Anaesthesiology, Hospital Universitari i Politécnic La Fe (OD-C), Perioperative Medicine Research Group Instituto de Investigación Sanitaria La Fe (IIS laFe), Valencia (GM, OD-C) and Pharmacology and Toxicology Department, School of Medicine, Complutense University of Madrid, Madrid, Spain (IG) the Department of Anaesthesiology and Critical Care, Hospital Clinic i Provincial, Barcelona, Spain (CF), CIBER de Enfermedades Respiratorias. Instituto de Salud Carlos III, Madrid, Spain (CF).'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Errando', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Mazzinari', 'Affiliation': ''}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Bellón', 'Affiliation': ''}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Díaz-Cambronero', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrando', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001128']
3741,31860601,Deep neuromuscular blockade during spinal surgery reduces intra-operative blood loss: A randomised clinical trial.,"BACKGROUND
Spinal surgery is usually performed in the prone position using a posterior approach. However, the prone position may cause venous engorgement in the back and thus increase surgical bleeding with interruption of surgery. The prone position also affects cardiac output since large vessels are compressed decreasing venous return to the heart.
OBJECTIVE
We hypothesised that deep neuromuscular blockade would be associated with less surgical bleeding during spinal surgery in the prone position.
DESIGN
Randomised, single blinded trial.
SETTING
University teaching hospital.
PARTICIPANTS
Eighty-eight patients in two groups.
INTERVENTIONS
Patients were randomly assigned to moderate neuromuscular blockade or deep neuromuscular blockade. In the moderate neuromuscular blockade group, administration of rocuronium was adjusted such that the train-of-four count was one to two. In the deep neuromuscular blockade group, rocuronium administration was adjusted such that the train-of-four count was zero with a posttetanic count 2 or less.
MAIN OUTCOME MEASURES
The primary outcome was the volume of intra-operative surgical bleeding. The surgeon's satisfaction with operating conditions, haemodynamic and respiratory status, and postoperative pain scores were evaluated.
RESULTS
The median [IQR] volume of intra-operative surgical bleeding was significantly less in the deep neuromuscular blockade group than in the moderate neuromuscular blockade group; 300 ml [200 to 494] vs. 415 ml [240 to 601]; difference: 117 ml (95% CI, 9 to 244; P = 0.044). The mean ± SD surgeon's satisfaction with the intra-operative surgical conditions was greater in the deep neuromuscular blockade group than in the moderate neuromuscular blockade group; 3.5 ± 1.0 vs. 2.9 ± 0.9 (P = 0.004). In intergroup comparisons of respiratory variables, peak inspiratory pressure was lower in the deep neuromuscular blockade group overall (P < 0.001). The median [IQR] postoperative pain score was lower in the deep neuromuscular blockade group than the moderate neuromuscular blockade group; 50 [36 to 60] vs. 60 [50 to 70], (P = 0.023).
CONCLUSION
Deep neuromuscular blockade reduced intra-operative surgical bleeding in patients undergoing spinal surgery. This may be related to greater relaxation in the back muscles and lower intra-operative peak inspiratory pressure when compared with moderate neuromuscular blockade.
TRIAL REGISTRATION
KCT0001264 (http://cris.nih.go.kr).",2020,"The median [IQR] postoperative pain score was lower in the deep neuromuscular blockade group than the moderate neuromuscular blockade group; 50 [36 to 60] vs. 60 [50 to 70], (P = 0.023).
","['Eighty-eight patients in two groups', 'patients undergoing spinal surgery', 'University teaching hospital']","['spinal surgery', 'rocuronium', 'moderate neuromuscular blockade or deep neuromuscular blockade']","['median [IQR] volume of intra-operative surgical bleeding', 'intra-operative surgical bleeding', ""surgeon's satisfaction with operating conditions, haemodynamic and respiratory status, and postoperative pain scores"", ""mean\u200a±\u200aSD surgeon's satisfaction with the intra-operative surgical conditions"", 'volume of intra-operative surgical bleeding', 'median [IQR] postoperative pain score', 'surgical bleeding', 'peak inspiratory pressure', 'intra-operative blood loss']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",88.0,0.185799,"The median [IQR] postoperative pain score was lower in the deep neuromuscular blockade group than the moderate neuromuscular blockade group; 50 [36 to 60] vs. 60 [50 to 70], (P = 0.023).
","[{'ForeName': 'Woon-Seok', 'Initials': 'WS', 'LastName': 'Kang', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine (WS-K, CS-O, KYR, MHK, SH-K), Department of Orthopedic Surgery, Konkuk University Medical Center (TH-K, SHL), Department of Medicine, Institute of Biomedical Science and Technology (WS-K, CS-O, KYR, TH-K, SHL, SH-K) and Department of Infection and Immunology, Konkuk University School of Medicine, Seoul, South Korea (SH-K).'}, {'ForeName': 'Chung-Sik', 'Initials': 'CS', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Ka Y', 'Initials': 'KY', 'LastName': 'Rhee', 'Affiliation': ''}, {'ForeName': 'Min H', 'Initials': 'MH', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Tae-Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Suk H', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Seong-Hyop', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001135']
3742,32022413,Are soluble ST2 levels influenced by vitamin D and/or the seasons?,"Objective
Cardiovascular disease manifestation and several associated surrogate markers, such as vitamin D, have shown substantial seasonal variation. A promising cardiovascular biomarker, soluble ST2 (sST2), has not been investigated in this regard – we therefore determined if systemic levels of sST2 are affected by seasonality and/or vitamin D in order to investigate their clinical interrelation and usability.
Design
sST2 levels were measured in two cohorts involving hypertensive patients at cardiovascular risk, the Styrian Vitamin D Hypertension Trial (study A; RCT design, 8 weeks 2800 IU cholecalciferol daily) and the Ludwigshafen Risk and Cardiovascular Health Study (LURIC; study B; cross-sectional design).
Methods
The effects of a vitamin D intervention on sST2 levels were determined in study A using ANCOVA, while seasonality of sST2 levels was determined in study B using ANOVA.
Results
The concentrations of sST2 remained unchanged by a vitamin D intervention in study A, with a mean treatment effect (95% confidence interval) of 0.1 (−0.6 to 0.8) ng/mL; P = 0.761), despite a rise in 25(OH)D (11.3 (9.2–13.5) ng/mL; P < 0.001) compared to placebo. In study B, seasonal variations were present in 25(OH)D levels in men and women with or without heart failure (P < 0.001 for all subgroups), while sST2 levels remained unaffected by the seasons in all subgroups.
Conclusions
Our study provides the first evidence that systemic sST2 levels are not interrelated with vitamin D levels or influenced by the seasons in subjects at cardiovascular risk.",2019,"The concentrations of sST2 remained unchanged by a vitamin D intervention in study A, with a mean treatment effect (95% confidence interval) of 0.1 (−0.6 to 0.8) ng/mL; P = 0.761), despite a rise in 25(OH)D (11.3 (9.2–13.5) ng/mL; P < 0.001) compared to placebo.",[],"['placebo', 'vitamin D intervention']","['concentrations of sST2', 'sST2 levels']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.20698,"The concentrations of sST2 remained unchanged by a vitamin D intervention in study A, with a mean treatment effect (95% confidence interval) of 0.1 (−0.6 to 0.8) ng/mL; P = 0.761), despite a rise in 25(OH)D (11.3 (9.2–13.5) ng/mL; P < 0.001) compared to placebo.","[{'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Francic', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Keppel', 'Affiliation': 'Department of Laboratory Medicine, Paracelsus Medical University, Salzburg, Austria'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Schwetz', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Trummer', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Pandis', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Borzan', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}, {'ForeName': 'Martin', 'Initials': 'MR', 'LastName': 'Grübler', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}, {'ForeName': 'Nicolas', 'Initials': 'ND', 'LastName': 'Verheyen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}, {'ForeName': 'Marcus', 'Initials': 'ME', 'LastName': 'Kleber', 'Affiliation': 'Vth Department of Medicine (Nephrology, Hypertensiology, Rheumatology, Endocrinology, Diabetology), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany'}, {'ForeName': 'Graciela', 'Initials': 'G', 'LastName': 'Delgado', 'Affiliation': 'Vth Department of Medicine (Nephrology, Hypertensiology, Rheumatology, Endocrinology, Diabetology), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany'}, {'ForeName': 'Angela', 'Initials': 'AP', 'LastName': 'Moissl', 'Affiliation': 'Vth Department of Medicine (Nephrology, Hypertensiology, Rheumatology, Endocrinology, Diabetology), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dieplinger', 'Affiliation': 'Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz, Linz, Austria'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'März', 'Affiliation': 'Vth Department of Medicine (Nephrology, Hypertensiology, Rheumatology, Endocrinology, Diabetology), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Tomaschitz', 'Affiliation': 'Specialist Clinic of Rehabilitation Bad Gleichenberg, Bad Gleichenberg, Austria'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pilz', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Obermayer-Pietsch', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}]",Endocrine connections,['10.1530/EC-19-0090']
3743,31387381,Outpatient vs Home Management Protocol Results for Plantar Fasciitis.,"BACKGROUND
We compared the effectiveness of stretching and strengthening exercises combined with myofascial releasing and mobilization techniques to a stretching and strengthening only home program in plantar fasciitis (PF) management.
METHOD
The study included 53 feet of 47 patients with plantar fasciitis (35 women / 12 men; mean age 48.9±11.2 years). Pain, disability, and activity restrictions were assessed by Foot Function Index (FFI), and first step pain was graded by visual analog scale (VAS). Ankle range of motion (ROM), gastrocnemius-soleus flexibility, proprioception, dynamic balance, and foot sensation were also considered. The patients were randomly divided into outpatient clinic treatment (Outpatient, n = 27 feet) and home rehabilitation groups (Home, n = 26 feet). Patient education was routine for all at the beginning of the management programs. In the Outpatient group, the foot-ankle-hip exercise program, myofascial releasing, and joint and soft tissue mobilization techniques were ""hands on"" at a clinic (twice a week for 8 weeks), whereas the Home group completed their home rehabilitation program on their own (8 weeks' duration with follow-ups every week).
RESULTS
VAS, FFI, ROM, balance, proprioception, foot sense, and flexibility improved at the eighth week in both groups according to intragroup comparison ( P < .05). When the 2 groups were compared, the results of plantar flexion range, balance, proprioception, foot sensation, flexibility, FFI, and VAS showed significant improvements in the Outpatient vs the Home group ( P < .05). Also, the FFI and VAS scores at the sixth month were superior in the Outpatient group ( P < .05).
CONCLUSION
A combined supervised management protocol had superior clinical results in plantar fasciitis management.
LEVEL OF EVIDENCE
Level II, comparative study.",2019,"Also, the FFI and VAS scores at the sixth month were superior in the Outpatient group ( P < .05).
","['Plantar Fasciitis', '53 feet of 47 patients with plantar fasciitis (35 women / 12 men; mean age 48.9±11.2 years']","['foot-ankle-hip exercise program, myofascial releasing, and joint and soft tissue mobilization techniques were ""hands on"" at a clinic', 'Home group completed their home rehabilitation program', 'stretching and strengthening exercises combined with myofascial releasing and mobilization techniques to a stretching and strengthening only home program']","['FFI and VAS scores', 'Pain, disability, and activity restrictions', 'plantar flexion range, balance, proprioception, foot sensation, flexibility, FFI, and VAS', 'Ankle range of motion (ROM), gastrocnemius-soleus flexibility, proprioception, dynamic balance, and foot sensation', 'VAS, FFI, ROM, balance, proprioception, foot sense, and flexibility', 'Foot Function Index (FFI), and first step pain was graded by visual analog scale (VAS']","[{'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0454362', 'cui_str': 'Hip exercises (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",53.0,0.0158015,"Also, the FFI and VAS scores at the sixth month were superior in the Outpatient group ( P < .05).
","[{'ForeName': 'Elif Tuğçe', 'Initials': 'ET', 'LastName': 'Çil', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Yeditepe University, Istanbul, Atasehir, Turkey.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şaylı', 'Affiliation': 'Division of Orthopedics and Traumatology, Yeditepe University, Istanbul, Turkey.'}, {'ForeName': 'Feryal', 'Initials': 'F', 'LastName': 'Subaşı', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Yeditepe University, Istanbul, Atasehir, Turkey.'}]",Foot & ankle international,['10.1177/1071100719865302']
3744,31930360,Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial.,"Importance
First-line behavioral and drug therapies for overactive bladder (OAB) symptoms in men are effective but not usually curative.
Objective
To determine whether combining behavioral and drug therapies improves outcomes compared with each therapy alone for OAB in men and to compare 3 sequences for implementing combined therapy.
Design, Setting, and Participants
In this 3-site, 2-stage, 3-arm randomized clinical trial, participants were randomized to 6 weeks of behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy for all groups. Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours. Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019.
Interventions
Behavioral therapy consisted of pelvic floor muscle training with urge suppression strategies and delayed voiding. Drug therapy included an antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg).
Main Outcomes and Measures
Seven-day bladder diaries completed before and after each 6-week treatment stage were used to calculate reduction in frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia). Other secondary outcomes included validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score.
Results
Of the 204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years. A total of 21 men discontinued treatment and 183 completed treatment. Mean (SD) voids per 24 hours decreased significantly in all 3 groups from baseline to 6-week follow-up (behavioral therapy: 11.7 [2.4] vs 8.8 [2.1]; change, 2.9 [2.4]; percentage change, 24.7%; P < .001; drug therapy: 11.8 [2.5] vs 10.3 [2.7]; change, 1.5 [2.3]; percentage change, 12.7%; P < .001; combined therapy: 11.8 [2.4] vs 8.2 [2.3]; change, 3.6 [2.1]; percentage change, 30.5%; P < .001). Intent-to-treat analyses indicated that posttreatment mean (SD) voiding frequencies were significantly lower in those receiving combined therapy compared with drug therapy alone (8.2 [2.3] vs 10.3 [2.7]; P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001). At 12-week follow-up, after all groups had received combined therapy, improvements in mean (SD) voids per 24 hours were also greatest for those receiving initial combined therapy compared with baseline (behavioral therapy: 11.7 [2.4] vs 8.0 [2.2]; change, 3.7 [2.3]; percentage change, 31.6%; P < .001; drug therapy: 11.8 [2.5] vs 8.6 [2.3]; change, 3.2 [2.5]; percentage change, 27.1%; P < .001; combined therapy: 11.8 [2.4] vs 8.0 [2.2]; change, 3.8 [2.1]; percentage change, 32.2%; P < .001), but there were no statistically significant group differences on primary or secondary measures.
Conclusions and Relevance
Combining behavioral and drug therapy yields greater improvements in OAB symptoms than drug therapy alone but not behavioral therapy alone. When using a stepped approach, it is reasonable to begin with behavioral therapy alone.
Trial Registration
ClinicalTrials.gov identifier: NCT01175382.",2020,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"['204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years', 'Overactive Bladder Symptoms in Men', 'Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019', 'Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours', '21 men discontinued treatment and 183 completed treatment']","['antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg', 'behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy', 'Combined Behavioral and Drug Therapy', 'pelvic floor muscle training with urge suppression strategies and delayed voiding']","['Mean (SD) voids per 24 hours', 'mean (SD) voids', 'frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia', 'OAB symptoms', 'validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score', 'posttreatment mean (SD) voiding frequencies', 'Main Outcomes and Measures\n\n\nSeven-day bladder diaries', 'overactive bladder (OAB) symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C2584336', 'cui_str': 'Frequency of urination (observable entity)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}]",,0.0524237,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Kraus', 'Affiliation': 'Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio.'}, {'ForeName': 'Theodore M', 'Initials': 'TM', 'LastName': 'Johnson', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Camille P', 'Initials': 'CP', 'LastName': 'Vaughan', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Goode', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.6398']
3745,31003911,"Atezolizumab with or without cobimetinib versus regorafenib in previously treated metastatic colorectal cancer (IMblaze370): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND
Microsatellite-stable metastatic colorectal cancer is typically unresponsive to immunotherapy. This phase 3 study was designed to assess atezolizumab plus cobimetinib in metastatic colorectal cancer. Here, we report the comparison of atezolizumab plus cobimetinib or atezolizumab monotherapy versus regorafenib in the third-line setting.
METHODS
IMblaze 370 is a multicentre, open-label, phase 3, randomised, controlled trial, done at 73 academic medical centres and community oncology practices in 11 countries. Patients aged at least 18 years with unresectable locally advanced or metastatic colorectal cancer, baseline Eastern Cooperative Oncology Group performance status of 0-1, and disease progression on or intolerance to at least two previous systemic chemotherapy regimens were enrolled. We used permuted-block randomisation (block size four) to assign patients (2:1:1) via an interactive voice and web response system to atezolizumab (840 mg intravenously every 2 weeks) plus cobimetinib (60 mg orally once daily for days 1-21 of a 28-day cycle), atezolizumab monotherapy (1200 mg intravenously every 3 weeks), or regorafenib (160 mg orally once daily for days 1-21 of a 28-day cycle). Stratification factors were extended RAS status (wild-type vs mutant) and time since diagnosis of first metastasis (<18 months vs ≥18 months). Recruitment of patients with high microsatellite instability was capped at 5%. The primary endpoint was overall survival in the intention-to-treat population. Safety was assessed in the population of patients who received at least one dose of their assigned treatment. IMblaze370 is ongoing and is registered with ClinicalTrials.gov, number NCT02788279.
FINDINGS
Between July 27, 2016, and Jan 19, 2017, 363 patients were enrolled (183 patients in the atezolizumab plus cobimetinib group, 90 in the atezolizumab group, and 90 in the regorafenib group). At data cutoff (March 9, 2018), median follow-up was 7·3 months (IQR 3·7-13·6). Median overall survival was 8·87 months (95% CI 7·00-10·61) with atezolizumab plus cobimetinib, 7·10 months (6·05-10·05) with atezolizumab, and 8·51 months (6·41-10·71) with regorafenib; the hazard ratio was 1·00 (95% CI 0·73-1·38; p=0·99) for the combination versus regorafenib and 1·19 (0·83-1·71; p=0·34) for atezolizumab versus regorafenib. Grade 3-4 adverse events were reported in 109 (61%) of 179 patients in the atezolizumab plus cobimetinib group, 28 (31%) of 90 in the atezolizumab group, and 46 (58%) of 80 in the regorafenib group. The most common all-cause grade 3-4 adverse events in the combination group were diarrhoea (20 [11%] of 179), anaemia (ten [6%]), increased blood creatine phosphokinase (12 [7%]), and fatigue (eight [4%]). Serious adverse events were reported in 71 (40%) of 179 patients in the combination group, 15 (17%) of 90 in the atezolizumab group, and 18 (23%) of 80 in the regorafenib group. Two treatment-related deaths occurred in the combination group (sepsis) and one in the regorafenib group (intestinal perforation).
INTERPRETATION
IMblaze370 did not meet its primary endpoint of improved overall survival with atezolizumab plus cobimetinib or atezolizumab versus regorafenib. The safety of atezolizumab plus cobimetinib was consistent with those of the individual drugs. These results underscore the challenge of expanding the benefit of immunotherapy to patients whose tumours have lower baseline levels of immune inflammation, such as those with microsatellite-stable metastatic colorectal cancer.
FUNDING
F Hoffmann-La Roche Ltd/Genentech Inc.",2019,"Median overall survival was 8·87 months (95% CI 7·00-10·61) with atezolizumab plus cobimetinib, 7·10 months (6·05-10·05) with atezolizumab, and 8·51 months (6·41-10·71) with regorafenib; the hazard ratio was 1·00 (95% CI 0·73-1·38; p=0·99) for the combination versus regorafenib and 1·19 (0·83-1·71; p=0·34) for atezolizumab versus regorafenib.","['73 academic medical centres and community oncology practices in 11 countries', 'Patients aged at least 18 years with unresectable locally advanced or metastatic colorectal cancer, baseline Eastern Cooperative Oncology Group performance status of 0-1, and disease progression on or intolerance to at least two previous systemic chemotherapy regimens were enrolled', 'Between July 27, 2016, and Jan 19, 2017, 363 patients were enrolled (183 patients in the atezolizumab plus cobimetinib group, 90 in the atezolizumab group, and 90 in the regorafenib group', 'metastatic colorectal cancer', 'previously treated metastatic colorectal cancer (IMblaze370']","['Atezolizumab with or without cobimetinib versus regorafenib', 'atezolizumab plus cobimetinib', 'IMblaze370', 'regorafenib', 'atezolizumab plus cobimetinib or atezolizumab monotherapy versus regorafenib', 'permuted-block randomisation (block size four) to assign patients (2:1:1) via an interactive voice and web response system to atezolizumab', 'atezolizumab versus regorafenib', 'cobimetinib', 'atezolizumab', 'atezolizumab monotherapy']","['anaemia', 'Grade 3-4 adverse events', 'blood creatine phosphokinase', 'diarrhoea', 'deaths', 'Median overall survival', 'overall survival', 'Safety', 'Serious adverse events']","[{'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4049146', 'cui_str': 'Cobimetinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C4049146', 'cui_str': 'Cobimetinib'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0853165', 'cui_str': 'Blood creatine phosphokinase'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",363.0,0.306777,"Median overall survival was 8·87 months (95% CI 7·00-10·61) with atezolizumab plus cobimetinib, 7·10 months (6·05-10·05) with atezolizumab, and 8·51 months (6·41-10·71) with regorafenib; the hazard ratio was 1·00 (95% CI 0·73-1·38; p=0·99) for the combination versus regorafenib and 1·19 (0·83-1·71; p=0·34) for atezolizumab versus regorafenib.","[{'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Eng', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Argilés', 'Affiliation': ""Vall d'Hebrón Institute of Oncology, Vall d'Hebrón University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Niall C', 'Initials': 'NC', 'LastName': 'Tebbutt', 'Affiliation': 'Medical Oncology, Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Fakih', 'Affiliation': 'City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kozloff', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'Segal', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'IRCCS Ospedale San Martino IST, Genova, Italy.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Ilsung', 'Initials': 'I', 'LastName': 'Chang', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyei', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Fortunato', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': 'Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Naples, Italy. Electronic address: fortunato.ciardiello@unicampania.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30027-0']
3746,32023382,Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.,,2020,,['Type 1 Diabetes'],['Closed-Loop Control'],[],"[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0350658,,"[{'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Zuñiga-Hernandez', 'Affiliation': 'Universidad Autónoma de Nuevo León, Monterrey, México.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Medrano-De Avila', 'Affiliation': 'Hospital Universitario Dr. José Eleuterio González, Monterrey, Mexico.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Rodríguez-Gutiérrez', 'Affiliation': 'Plataforma Invest Knowledge and Evaluation Research Unit México, Monterrey, Mexico rodriguezgutierrez.rene@mayo.edu.'}]",The New England journal of medicine,['10.1056/NEJMc1915995']
3747,31327701,"Renal Artery Denervation in Resistant Hypertension: The Good, The Bad and The Future.","Early studies of renal artery denervation (RAD) demonstrated efficacy in treating resistant hypertension patients with significant reduction in office blood pressure (BP). This resulted in a growing enthusiasm in the field and a rapid evolution of technology with expanding procedural indications. However, the first randomised sham-controlled trial, Symplicity HTN-3, failed to demonstrate a significant difference in BP reduction between the RAD and the sham control arm, which subsequently led to a major reduction in the clinical application of this procedure. Additionally, the results generated further interest into understanding the mechanism and factors affecting procedural success and identifying the limitations within the field. Many lessons were learned from Symplicity HTN-3 trial, and with recent evidence emerging for RAD in hypertension treatment, the field continues to be refined.",2020,"However, the first randomised sham-controlled trial, Symplicity HTN-3, failed to demonstrate a significant difference in BP reduction between the RAD and the sham control arm, which subsequently led to a major reduction in the clinical application of this procedure.",['Resistant Hypertension'],['renal artery denervation (RAD'],"['BP reduction', 'office blood pressure (BP']","[{'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C3544270', 'cui_str': 'Renal artery denervation'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0308955,"However, the first randomised sham-controlled trial, Symplicity HTN-3, failed to demonstrate a significant difference in BP reduction between the RAD and the sham control arm, which subsequently led to a major reduction in the clinical application of this procedure.","[{'ForeName': 'Sara I', 'Initials': 'SI', 'LastName': 'Al Raisi', 'Affiliation': 'Department of Cardiology, Westmead Hospital, Sydney, NSW, Australia; University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Pouliopoulos', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Swinnen', 'Affiliation': 'Department of Vascular Surgery, Westmead Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Thiagalingam', 'Affiliation': 'Department of Cardiology, Westmead Hospital, Sydney, NSW, Australia; University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Pramesh', 'Initials': 'P', 'LastName': 'Kovoor', 'Affiliation': 'Department of Cardiology, Westmead Hospital, Sydney, NSW, Australia; University of Sydney, Sydney, NSW, Australia. Electronic address: pramesh.kovoor@sydney.edu.au.'}]","Heart, lung & circulation",['10.1016/j.hlc.2019.06.723']
3748,30746642,Prompting Patients with Poorly Controlled Diabetes to Identify Visit Priorities Before Primary Care Visits: a Pragmatic Cluster Randomized Trial.,"BACKGROUND
Most patients with diabetes do not meet all evidence-based goals of care, and many patients report poor communication and lack of involvement in decision-making during primary care visits.
OBJECTIVE
To test the hypothesis that a ""Pre-Visit Prioritization"" secure email message could improve visit communication and glycemic control among patients with type 2 diabetes.
DESIGN
We conducted a pragmatic, provider-randomized, multi-site clinical trial from March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system.
PARTICIPANTS
Eligible patients had at least 1 year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c) > = 8.0%, and were registered users of the KPNC online patient portal.
INTERVENTIONS
Patients in the intervention arm, upon booking an appointment, received a secure email through the KPNC online portal with a link to the EHR allowing them to submit their top one or two priorities prior to the visit. Control patients received usual care.
MAIN MEASURES
Glycemic control; change in HbA1c 6 and 12 months after the initial visit; patient-reported outcomes related to patient-provider communication and patient care experiences.
KEY RESULTS
During the study period, 1276 patients had at least one eligible visit. In post-visit surveys (n = 457), more intervention arm patients reported preparing questions for their visit (72% vs 63%, p = 0.048) and being given treatment choices to consider (81% vs 73%, p = 0.041). Patients in both arms had similar reductions in HbA1c over the 12-month study period (0.56% ± 1.45%), with no significant differences between arms.
CONCLUSIONS
A ""light touch"" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care. Improving diabetes clinical outcomes through more effective primary care visits may require more intensive approaches to patient visit preparation.
TRIAL REGISTRY
NCT02375932.",2019,"CONCLUSIONS
A ""light touch"" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care.","['patients with diabetes', '1276 patients had at least one eligible visit', 'Eligible patients had at least 1\xa0year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c)\u2009>\u2009=\u20098.0%, and were registered users of the KPNC online patient portal', 'March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system', 'patients with type 2 diabetes', 'Patients with Poorly Controlled Diabetes to Identify Visit Priorities']","['secure email through the KPNC online portal with a link to the EHR', 'usual care']","['visit communication and glycemic control', 'patient-provider communication and patient care experiences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017313'}]",,0.111043,"CONCLUSIONS
A ""light touch"" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care.","[{'ForeName': 'Michelle T', 'Initials': 'MT', 'LastName': 'Vo', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Connie S', 'Initials': 'CS', 'LastName': 'Uratsu', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Estacio', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Altschuler', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Oakland Medical Center, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Stacey E', 'Initials': 'SE', 'LastName': 'Alexeeff', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Alyce S', 'Initials': 'AS', 'LastName': 'Adams', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Grant', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA. Richard.W.Grant@KP.org.'}]",Journal of general internal medicine,['10.1007/s11606-018-4756-4']
3749,32027158,Investigating tobacco withdrawal in response to reduced nicotine cigarettes among smokers with opioid use disorder and other vulnerabilities.,"Individuals with opioid use disorder (OUD) have high prevalence of smoking and poor cessation outcomes. Data suggest that smokers with OUD may experience heightened nicotine reinforcement and more severe tobacco withdrawal compared to smokers without OUD. The Food and Drug Administration is currently considering reducing the nicotine content of cigarettes to reduce smoking prevalence and smoking-related disease. It is critical to understand the effects of reduced nicotine content cigarettes (RNCCs) on tobacco withdrawal in this subgroup. In this secondary analysis, we investigated the ability of RNCCs to attenuate acute tobacco withdrawal and craving severity in smokers with OUD versus those without substance use disorders (SUDs). Smokers maintained on methadone or buprenorphine (opioid-maintained [OM]; n = 65) versus without other SUDs (i.e., non-SUD; n = 135) completed 5 laboratory sessions wherein they smoked their usual brand (UB) or a research cigarette varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g of tobacco) under double-blind, acute abstinence conditions. Participants completed the Minnesota Tobacco Withdrawal Scale, including a desire to smoke (craving) item, before and every 15 min for 1 hr following smoking each cigarette. Tobacco withdrawal and craving did not differ significantly by OM status in response to UB or RNCCs. In addition to the Dose × Time interaction, greater depression and cigarette dependence consistently predicted withdrawal and craving (ps < .05). Across all cigarettes, tobacco withdrawal and craving did not significantly differ by OM status, suggesting that smokers receiving opioid agonist treatment may respond favorably to RNCCs. Additional studies with larger and more diverse samples are needed to address this question more definitively. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Across all cigarettes, tobacco withdrawal and craving did not significantly differ by OM status, suggesting that smokers receiving opioid agonist treatment may respond favorably to RNCCs.","['smokers with opioid use disorder and other vulnerabilities', 'n = 65) versus without other SUDs (i.e., non-SUD; n = 135) completed 5', 'Individuals with opioid use disorder (OUD', 'smokers with OUD versus those without substance use disorders (SUDs']","['nicotine content cigarettes (RNCCs', 'methadone or buprenorphine', 'opioid-maintained [OM', 'laboratory sessions wherein they smoked their usual brand (UB) or a research cigarette varying in nicotine content']","['Minnesota Tobacco Withdrawal Scale, including a desire to smoke (craving) item', 'Tobacco withdrawal and craving', 'severe tobacco withdrawal', 'tobacco withdrawal and craving']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0499568,"Across all cigarettes, tobacco withdrawal and craving did not significantly differ by OM status, suggesting that smokers receiving opioid agonist treatment may respond favorably to RNCCs.","[{'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Priest', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Bergeria', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Davis', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Vermont Center on Behavior and Health.'}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Behavior and Health.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000350']
3750,30892987,"Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With BRAF V600E-Mutant Metastatic Colorectal Cancer: Safety Lead-In Results From the Phase III BEACON Colorectal Cancer Study.","PURPOSE
To determine the safety and preliminary efficacy of selective combination targeted therapy for BRAF V600E-mutant metastatic colorectal cancer (mCRC) in the safety lead-in phase of the open-label, randomized, three-arm, phase III BEACON Colorectal Cancer trial ( ClinicalTrials.gov identifier: NCT02928224; European Union Clinical Trials Register identifier: EudraCT2015-005805-35).
PATIENTS AND METHODS
Before initiation of the randomized portion of the BEACON Colorectal Cancer trial, 30 patients with BRAF V600E-mutant mCRC who had experienced treatment failure with one or two prior regimens were to be recruited to a safety lead-in of encorafenib 300 mg daily, binimetinib 45 mg twice daily, plus standard weekly cetuximab. The primary end point was safety, including the incidence of dose-limiting toxicities. Efficacy end points included overall response rate, progression-free survival, and overall survival.
RESULTS
Among the 30 treated patients, dose-limiting toxicities occurred in five patients and included serous retinopathy (n = 2), reversible decreased left ventricular ejection fraction (n = 1), and cetuximab-related infusion reactions (n = 2). The most common grade 3 or 4 adverse events were fatigue (13%), anemia (10%), increased creatine phosphokinase (10%), increased AST (10%), and urinary tract infections (10%). In 29 patients with BRAF V600E-mutant tumors (one patient had a non- BRAF V600E-mutant tumor and was not included in the efficacy analysis), the confirmed overall response rate was 48% (95% CI, 29.4% to 67.5%), median progression-free survival was 8.0 months (95% CI, 5.6 to 9.3 months), and median overall survival was 15.3 months (95% CI, 9.6 months to not reached), with median duration of follow-up of 18.2 months (range, 16.6 to 19.8 months).
CONCLUSION
In the safety lead-in, the safety and tolerability of the encorafenib, binimetinib, and cetuximab regimen is manageable and acceptable for initiation of the randomized portion of the study. The observed efficacy is promising compared with available therapies and, if confirmed in the randomized portion of the trial, could establish this regimen as a new standard of care for previously treated BRAF V600E-mutant mCRC.",2019,"The most common grade 3 or 4 adverse events were fatigue (13%), anemia (10%), increased creatine phosphokinase (10%), increased AST (10%), and urinary tract infections (10%).","['30 patients with BRAF V600E-mutant mCRC who had experienced treatment failure with one or two prior regimens were to be recruited to a safety lead-in of', 'Patients With BRAF', 'BRAF V600E-mutant metastatic colorectal cancer (mCRC', 'V600E-Mutant Metastatic Colorectal Cancer']","['Binimetinib, Encorafenib, and Cetuximab Triplet Therapy', 'encorafenib, binimetinib, and cetuximab regimen', 'encorafenib 300 mg daily, binimetinib 45 mg twice daily, plus standard weekly cetuximab', 'selective combination targeted therapy']","['safety and tolerability', 'overall response rate, progression-free survival, and overall survival', 'dose-limiting toxicities', 'median progression-free survival', 'left ventricular ejection fraction', 'incidence of dose-limiting toxicities', 'anemia', 'median overall survival', 'Safety Lead', 'creatine phosphokinase', 'overall response rate', 'urinary tract infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162643'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C3899947', 'cui_str': 'Binimetinib'}, {'cui': 'C4079208', 'cui_str': 'encorafenib'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",30.0,0.172122,"The most common grade 3 or 4 adverse events were fatigue (13%), anemia (10%), increased creatine phosphokinase (10%), increased AST (10%), and urinary tract infections (10%).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': '1 University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Huijberts', 'Affiliation': '2 Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': '3 West Cancer Center, Germantown, TN.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Yaeger', 'Affiliation': '4 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Pieter-Jan', 'Initials': 'PJ', 'LastName': 'Cuyle', 'Affiliation': '1 University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Elez', 'Affiliation': ""6 Vall d'Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Fakih', 'Affiliation': '7 City of Hope Comprehensive Cancer Center, Duarte, CA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Montagut', 'Affiliation': ""8 Hospital del Mar-Institut Hospital del Mar d'Investigacions Mèdiques, Universitat Pompeu Fabra, Barcelona, Spain.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': '9 Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': '10 National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': '11 Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Desai', 'Affiliation': '12 Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Fortunato', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': '13 University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Gollerkeri', 'Affiliation': '14 Array BioPharma Inc, Boulder, CO.'}, {'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Christy-Bittel', 'Affiliation': '14 Array BioPharma Inc, Boulder, CO.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Maharry', 'Affiliation': '14 Array BioPharma Inc, Boulder, CO.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sandor', 'Affiliation': '14 Array BioPharma Inc, Boulder, CO.'}, {'ForeName': 'Jan H M', 'Initials': 'JHM', 'LastName': 'Schellens', 'Affiliation': '15 Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kopetz', 'Affiliation': '16 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""6 Vall d'Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02459']
3751,31947884,Play as a Method to Reduce Overweight and Obesity in Children: An RCT.,"BACKGROUND
Overweight and obesity are the result of a complex interaction between genetic and environmental factors, which begins prenatally.
AIM
To analyse an intervention based on play as a means of improving the body composition of children who are overweight or obese.
METHODS
The Kids-Play study is a randomized clinical trial (RCT) consisting of 49 children aged 8-12 years on a nine-month intervention programme based on physical activity, play and nutritional advice. Controls had another 49 children, who received only nutritional advice.
RESULTS
The play-based intervention achieved a moderate-vigorous level of physical activity in the study group of 81.18 min per day, while the corresponding level for the control group was only 37.34 min. At the start of the intervention, the children in the study group had an average body fat content of 41.66%, a level that decreased to 38.85% by the end of the programme. Among the control group, body fat increased from 38.83% to 41.4% during the same period.
CONCLUSIONS
The intervention programme considered, based on both play and nutritional recommendations, produced a decrease in body fat among children aged 8-12 years. However, the control group, which received only nutritional recommendations, experienced an increase in body weight.",2020,"The play-based intervention achieved a moderate-vigorous level of physical activity in the study group of 81.18 min per day, while the corresponding level for the control group was only 37.34 min.","['children who are overweight or obese', 'Overweight and Obesity in Children', 'children aged 8-12 years', 'Controls had another 49 children, who received only nutritional advice', '49 children aged 8-12 years on a nine-month intervention programme based on physical activity, play and nutritional advice']",[],"['body weight', 'average body fat content', 'body fat', 'moderate-vigorous level of physical activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",49.0,0.0252942,"The play-based intervention achieved a moderate-vigorous level of physical activity in the study group of 81.18 min per day, while the corresponding level for the control group was only 37.34 min.","[{'ForeName': 'Antonio Manuel', 'Initials': 'AM', 'LastName': 'Sánchez-López', 'Affiliation': 'Department of Human Motricity and Sports Performance, University of Seville, 41004 Seville, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Menor-Rodríguez', 'Affiliation': 'Research group CTS 367, Andalusia, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Sánchez-García', 'Affiliation': 'Research group CTS 367, Andalusia, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Aguilar-Cordero', 'Affiliation': 'Research group CTS 367, Andalusia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17010346']
3752,31977627,Postoperative residual neuromuscular blockade after reversal based on a qualitative peripheral nerve stimulator response: A randomised controlled trial.,"BACKGROUND
Incomplete recovery of neuromuscular blockade is a common postoperative adverse event in the postanaesthesia care unit.
OBJECTIVE
We examined and compared the incidence of residual neuromuscular blockade when the recommended dose of neostigmine or sugammadex was administered according to a qualitative nerve stimulator response.
DESIGN
A randomised controlled trial.
SETTING
A tertiary care hospital in South Korea from September 2017 to November 2017.
PATIENTS
Eighty patients aged between 18 and 69 years were included in this study. All were patients scheduled to undergo elective laparoscopic cholecystectomy and who had an American Society of Anaesthesiologists physical status of one or two were eligible.
INTERVENTIONS
Patients were allocated randomly to receive neostigmine or sugammadex at the end of surgery. The doses of the reversal agents were based on the response to peripheral nerve stimulation, which was discontinued after administration of the reversal agent.
MAIN OUTCOME MEASURES
The primary outcome was the incidence of postoperative residual neuromuscular blockade. The secondary outcomes were the incidences of symptoms or signs of residual neuromuscular blockade such as hypoxaemia, inability to maintain head-lift for 5 s and diplopia.
RESULTS
The incidence of residual neuromuscular blockade on arrival in the recovery room was 44.4% in the neostigmine group and 0% in the sugammadex group (P < 0.0001, relative risk = 1.80, 95% confidence interval 1.36 to 2.41). The incidences of adverse events in the recovery room were low and comparable between the groups.
CONCLUSION
The incidence of residual neuromuscular blockade on arrival in the recovery room was significantly higher in the neostigmine group than that in the sugammadex group. However, the incidence of adverse events was similar in the neostigmine and sugammadex groups.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03292965.",2020,The incidence of residual neuromuscular blockade on arrival in the recovery room was significantly higher in the neostigmine group than that in the sugammadex group.,"['A tertiary care hospital in South Korea from September 2017 to November 2017', 'Eighty patients aged between 18 and 69 years', 'All were patients scheduled to undergo elective laparoscopic cholecystectomy and who had an American Society of Anaesthesiologists physical status of one or two were eligible']","['neostigmine or sugammadex', 'neostigmine']","['adverse events', 'incidence of postoperative residual neuromuscular blockade', 'incidences of symptoms or signs of residual neuromuscular blockade such as hypoxaemia, inability to maintain head-lift for 5\u200as and diplopia']","[{'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4042763', 'cui_str': 'Postoperative Residual Curarization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0012569', 'cui_str': 'Double Vision'}]",80.0,0.304474,The incidence of residual neuromuscular blockade on arrival in the recovery room was significantly higher in the neostigmine group than that in the sugammadex group.,"[{'ForeName': 'Yea-Ji', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Konkuk University Medical Centre, Seoul (Y-JL), Department of Anaesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam-si (A-YO, J-WH, J-HP, J-PH), Department of Anaesthesiology and Pain Medicine, Seoul National University College of Medicine (B-WK) and Department of Dental Anaesthesiology, Seoul National University Dental Hospital, Seoul, South Korea (K-SS).'}, {'ForeName': 'Ah-Young', 'Initials': 'AY', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Bon-Woo', 'Initials': 'BW', 'LastName': 'Koo', 'Affiliation': ''}, {'ForeName': 'Ji-Won', 'Initials': 'JW', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Jae-Hee', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jung-Pyo', 'Initials': 'JP', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Kwang-Suk', 'Initials': 'KS', 'LastName': 'Seo', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001157']
3753,31147187,Effects of a fully magnetically levitated centrifugal-flow or axial-flow left ventricular assist device on von Willebrand factor: A prospective multicenter clinical trial.,"BACKGROUND
Increased shear stress conferred upon the circulation by continuous-flow pumps is associated with hemocompatibility-related adverse events, principally bleeding within the gastrointestinal system, and linked to the degradation of high-molecular-weight multimers (HMWMs) of von Willebrand factor (vWF). We evaluated the structure and functional characteristics of vWF HMWMs in patients with the fully magnetically levitated centrifugal-flow HeartMate 3 (HM3) and the continuous axial-flow HeartMate II (HMII) pump. Findings were correlated with bleeding events.
METHODS
In a prospective, multicenter, comparative cohort study, 60 patients from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 Continued Access Protocol (NCT02892955) with an HM3 pump were compared with 30 randomly selected HMII patients from the PREVENtion of HeartMate II Pump Thrombosis study (NCT02158403) biobank. The primary end point was the difference in the normalized vWF HMWM ratio (ratio of the HMWMs to the intermediate- and low-molecular-weight multimers, normalized to pooled plasma from healthy volunteers) between the HM3 and the HMII pump at 90 days after implantation. Assay tests for vWF activity, vWF antigen, vWF activity to antigen ratio, coagulation factor VIII activity, and ADAMTS13 activity were measured by using standard protocols. Differences in these markers were compared in the context of clinical characteristics and correlated with adjudicated bleeding events within the HM3 group.
RESULTS
Of 51 and 29 evaluable patients in the HM3 and HMII arms, respectively, those implanted with the HM3 pump exhibited greater preservation of the vWF HMWM ratio than those with the HMII pump at 90 days after implantation (54.1% vs 42.4%, p < 0.0001). Laboratory values for all vWF assays (antigen, activity, and coagulation factor VIII activity) remained within the normal functional range with no significant differences observed between the pumps at 90 days after implantation. At baseline, there was a decrease in the structural integrity of vWF HMWMs that correlated with increasing heart failure severity as measured by the Interagency Registry for Mechanically Assisted Circulatory Support profile. Multivariable modeling identified the HM3 pump as the only independent variable that determined post-implantation preservation of the structural integrity of vWF HMWMs.
CONCLUSIONS
This prospective, multicenter comparative analysis study demonstrates that the fully magnetically levitated centrifugal-flow HM3 left ventricular assist device is associated with greater preservation of the structure of vWF HMWMs than the HMII mechanical bearing axial-flow pump.",2019,"At baseline, there was a decrease in the structural integrity of vWF HMWMs that correlated with increasing heart failure severity as measured by the Interagency Registry for Mechanically Assisted Circulatory Support profile.","['patients with the fully magnetically levitated centrifugal-flow HeartMate 3 (HM3) and the continuous axial-flow HeartMate II (HMII) pump', '60 patients from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 Continued Access Protocol (NCT02892955) with an HM3 pump were compared with 30 randomly selected HMII patients from the PREVENtion of HeartMate II Pump Thrombosis study (NCT02158403) biobank']",['fully magnetically levitated centrifugal-flow or axial-flow left ventricular assist device'],"['adjudicated bleeding events', 'Laboratory values for all vWF assays (antigen, activity, and coagulation factor VIII activity', 'bleeding events', 'normalized vWF HMWM ratio (ratio of the HMWMs', 'vWF activity, vWF antigen, vWF activity to antigen ratio, coagulation factor VIII activity, and ADAMTS13 activity', 'structural integrity of vWF HMWMs', 'vWF HMWM ratio', 'heart failure severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301962', 'cui_str': 'Centrifugal'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1301962', 'cui_str': 'Centrifugal'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",60.0,0.0319889,"At baseline, there was a decrease in the structural integrity of vWF HMWMs that correlated with increasing heart failure severity as measured by the Interagency Registry for Mechanically Assisted Circulatory Support profile.","[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Ochsner Medical Center, New Orleans, Louisiana.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'University of Chicago School of Medicine and Medical Center, Chicago, Illinois.'}, {'ForeName': 'Paolo C', 'Initials': 'PC', 'LastName': 'Colombo', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Keerthy', 'Initials': 'K', 'LastName': 'Narisetty', 'Affiliation': 'Baptist Health Medical Center, Little Rock, Arkansas.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Long', 'Affiliation': 'Integris Baptist Medical Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Bhimaraj', 'Affiliation': 'Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cleveland', 'Affiliation': 'University of Colorado Hospital, Aurora, Colorado.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Montefiore Einstein Center for Heart and Vascular Care, Bronx, New York.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Stulak', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Samer S', 'Initials': 'SS', 'LastName': 'Najjar', 'Affiliation': 'Medstar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Adler', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Dembitsky', 'Affiliation': 'Sharp Memorial Hospital, San Diego, California.'}, {'ForeName': 'Sami I', 'Initials': 'SI', 'LastName': 'Somo', 'Affiliation': 'Abbott, Chicago, Illinois.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Crandall', 'Affiliation': 'Abbott, Chicago, Illinois.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jean Marie', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: mmehra@bwh.harvard.edu.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2019.05.006']
3754,31867643,Increasing Quit Attempts by Transitioning to Very Low Nicotine Content Cigarettes Versus Reducing Number of Cigarettes Per Day: A Secondary Analysis of an Exploratory Randomized Trial.,"INTRODUCTION
The Food and Drug Administration (FDA) has proposed reducing nicotine with very low nicotine content (VLNC) cigarettes. In contrast, reducing nicotine by reducing number of cigarettes per day (CPD) is common. Our prior findings demonstrate that VLNC cigarettes decreased dependence more and were more acceptable than reducing CPD. This secondary analysis explored which reduction strategy increased quit attempts (QA), self-efficacy, or intention to quit more.
METHODS
This is a secondary analysis of 68 adult daily smokers not ready to quit randomized to smoke VLNC cigarettes versus reduce CPD over 5 weeks. All participants smoked study cigarettes with nicotine yield similar to most commercial cigarettes ad lib for 1 week (baseline). Participants were then randomized to gradually reduce to 70%, 35%, 15%, and 3% of baseline nicotine over 4 weeks by either (1) transitioning to lower nicotine VLNC cigarettes or (2) reducing the number of full nicotine CPD. All participants received nicotine patches to aid reduction. We assessed (1) QAs using nightly and weekly self-reports, (2) Velicer's Self-Efficacy to Quit measure weekly, and (3) the Intention-to-Quit Ladder nightly.
RESULTS
More CPD (41%) than VLNC (17%) participants made any QA (odds ratio = 3.4, 95% confidence interval = 1.1, 10.5). There was no difference in QAs ≥24 h. Self-efficacy increased for VLNC but not CPD participants (interaction: F = 3.7, p < .01). The condition by time interaction for intention-to-quit was not significant.
CONCLUSIONS
Reducing number of CPD increased QAs more than reducing nicotine via switching to VLNC cigarettes. The lack of difference in longer QAs suggests replication tests are needed.
IMPLICATIONS
Reducing the frequency of smoking behavior (ie, CPD) could be a more effective strategy to increase QAs than reducing the magnitude of nicotine in each cigarette (ie, VLNC) per se.",2019,"There was no difference in QAs ≥24 h. Self-efficacy increased for VLNC but not CPD participants (interaction: F = 3.7, p < .01).",['68 adult daily smokers not ready to quit randomized to'],"['nicotine patches', 'smoke VLNC cigarettes', 'baseline nicotine over 4 weeks by either (1) transitioning to lower nicotine VLNC cigarettes or (2) reducing the number of full nicotine CPD', 'nicotine', 'Nicotine Content Cigarettes']","['number of cigarettes per day (CPD', 'frequency of smoking behavior (ie, CPD', 'quit attempts (QA), self-efficacy, or intention to quit more', 'QAs ≥24 h. Self-efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",68.0,0.0778905,"There was no difference in QAs ≥24 h. Self-efficacy increased for VLNC but not CPD participants (interaction: F = 3.7, p < .01).","[{'ForeName': 'Elias M', 'Initials': 'EM', 'LastName': 'Klemperer', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, Burlington, VT.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, Burlington, VT.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Callas', 'Affiliation': 'Department of Biostatistics, University of Vermont, Burlington, VT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz145']
3755,31868983,Nasal high flow in preterm infants: A dose-finding study.,"OBJECTIVE
To investigate the relationship between applied flows of nasal high flow (NHF) and physiological outcomes and work of breathing (WOB), to identify an optimal delivery flow which results in reduced WOB in preterm infants.
DESIGN
A prospective observational clinical study with randomly applied NHF rates.
PATIENTS AND SETTING
Preterm infants within 72 hours of commencement of NHF respiratory support.
INTERVENTIONS
Infants were initially placed on 8 L/min of NHF and flows of 2, 4, and 6 L/min were then applied in random order.
MEASUREMENTS AND RESULTS
WOB was measured using transcutaneous electromyography and respiratory inductance plethysmography. Physiological variables were also recorded. Measurements taken 10 minutes after each flow change were compared with 8 L/min. Sixteen infants with a median gestational age of 28 (range 24-31) weeks and postnatal age of 14 (2-55) days were included in the study. The median flow rate before the study was 6 (4-8) L/min and a fraction of inspired oxygen (FiO 2 ) was 0.21 (0.21-0.26). Changes in flow resulted in changes in activity in the front diaphragm (P = .027) and intercostals (P = .034). The electrical activity of the front diaphragm at 8 L/min was significantly lower than that at 2 L/min (P = .016). Respiratory rate was lowest at 6 L/min (P = .002) and SpO 2 /FiO 2 was highest at 8 L/min (P < .04).
CONCLUSION
In preterm infants, changes in WOB resulting from randomly applied levels of NHF can be demonstrated by measuring the electrical activity of the diaphragm and intercostal muscles with transcutaneous electromyography. In combination with physiological measurements, the similarities in electrical activity between 4, 6, and 8 L/min suggest that these three flows may be equally as effective.",2020,Changes in flow resulted in changes in activity in the front diaphragm (P = .027) and intercostals (P = .034).,"['Sixteen infants with a median gestational age of 28 (range 24-31) weeks and postnatal age of 14 (2-55) days were included in the study', 'Preterm infants within 72\u2009hours of commencement of NHF respiratory support', 'preterm infants']",[],"['electrical activity of the front diaphragm', 'transcutaneous electromyography and respiratory inductance plethysmography', 'Respiratory rate', 'median flow rate', 'nasal high flow (NHF) and physiological outcomes and work of breathing (WOB']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],"[{'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}]",,0.0359747,Changes in flow resulted in changes in activity in the front diaphragm (P = .027) and intercostals (P = .034).,"[{'ForeName': 'Judith L', 'Initials': 'JL', 'LastName': 'Hough', 'Affiliation': 'Program for Optimising Outcomes for Mothers and Babies At-Risk, Mater Research Institute, The University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Shearman', 'Affiliation': 'Program for Optimising Outcomes for Mothers and Babies At-Risk, Mater Research Institute, The University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Jardine', 'Affiliation': 'Program for Optimising Outcomes for Mothers and Babies At-Risk, Mater Research Institute, The University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': 'Pediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, South Brisbane, Queensland, Australia.'}]",Pediatric pulmonology,['10.1002/ppul.24617']
3756,29112701,"Effect of docetaxel duration on clinical outcomes: exploratory analysis of CLEOPATRA, a phase III randomized controlled trial.","Background
Combination pertuzumab, trastuzumab, and docetaxel (D) is considered standard first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. This post hoc, exploratory analysis of CLEOPATRA study data evaluated the clinical effects of D treatment duration within this regimen. The clinical benefits of pertuzumab and trastuzumab by different durations of D treatment were also evaluated.
Patients and methods
Patients with HER2-positive metastatic breast cancer received trastuzumab and D plus pertuzumab or placebo. Clinical outcomes were analyzed by the number of D cycles that patients received (<6D, 6D, or >6D). Progression-free survival (PFS) and overall survival (OS) for each treatment arm within each D cycle group were estimated using the Kaplan-Meier approach. Time-dependent, multivariate Cox regression was applied to estimate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for HER2-targeted therapy and D cycle groups.
Results
Overall, 804 patients received <6D (n = 119), 6D (n = 210), or >6D (n = 475) cycles. After adjusting for pertuzumab benefits versus placebo (PFS HR = 0.61, 95% CI 0.51-0.74, P < 0.0001; OS HR = 0.60, 95% CI, 0.49-0.74, P < 0.0001), >6D versus 6D cycles was not associated with statistically significant improvements in PFS (HR = 0.80, 95% CI 0.63-1.01, P = 0.0640) or OS (HR = 0.88, 95% CI 0.69-1.12, P = 0.3073). Consistent improvements in PFS and OS were observed with pertuzumab versus placebo, irrespective of D duration. The HRs for PFS were 0.395, 0.615, and 0.633 for <6D, 6D, and >6D cycles, respectively (P < 0.05 for all D cycle groups). Corresponding HRs for OS were 0.577, 0.700, and 0.612, respectively (P < 0.05 for <6D and >6D).
Conclusions
After accounting for pertuzumab benefits, more than six cycles of D treatment was not associated with significant improvements in either PFS or OS compared with six cycles. The addition of pertuzumab to trastuzumab improved clinical outcomes versus trastuzumab plus placebo, regardless of D treatment duration.
ClinicalTrials.gov identifier
NCT00567190.",2017,"6D versus 6D cycles was not associated with statistically significant improvements in PFS (HR = 0.80, 95% CI 0.63-1.01, P = 0.0640) or OS (HR = 0.88, 95% CI 0.69-1.12, P = 0.3073).","['Patients and methods\n\n\nPatients with HER2-positive metastatic breast cancer received', 'human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer']","['pertuzumab versus placebo', 'trastuzumab and D plus pertuzumab or placebo', 'placebo', 'pertuzumab and trastuzumab', 'docetaxel', 'trastuzumab plus placebo', '\n\n\nCombination pertuzumab, trastuzumab, and docetaxel (D']","['Progression-free survival (PFS) and overall survival (OS', 'PFS or OS', 'PFS and OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.355527,"6D versus 6D cycles was not associated with statistically significant improvements in PFS (HR = 0.80, 95% CI 0.63-1.01, P = 0.0640) or OS (HR = 0.88, 95% CI 0.69-1.12, P = 0.3073).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK;. Electronic address: david.miles@doctors.org.uk.'}, {'ForeName': 'Y-H', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fung', 'Affiliation': 'BioOncology.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Biostatistics, Genentech Inc., South San Francisco, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Knott', 'Affiliation': 'Clinical Development, Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Heeson', 'Affiliation': 'Clinical Development, Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Beattie', 'Affiliation': 'BioOncology.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx406']
3757,31601111,Simulation-Based Mastery Learning Improves Patient and Caregiver Ventricular Assist Device Self-Care Skills: A Randomized Pilot Trial.,"BACKGROUND
No recognized standards exist for teaching patients and their caregivers ventricular assist device (VAD) self-care skills. We compared the effectiveness of a VAD simulation-based mastery learning (SBML) self-care training curriculum with usual VAD self-care training.
METHODS AND RESULTS
VAD patients and their caregivers were randomized to SBML or usual training during their implant hospitalization. The SBML group completed a pretest on 3 VAD self-care skills (controller, power source, and dressing change), then viewed videos and participated in deliberate practice on a simulator. SBML participants took a posttest and were required to meet or exceed a minimum passing standard for each of the skills. The usual training group completed the existing institutional VAD self-care teaching protocol. Before hospital discharge, the SBML and usual training groups took the same 3 VAD self-care skills tests. We compared demographic and clinical information, self-confidence, total participant training time, and skills performance between groups. Forty participants completed the study in each group. There were no differences in demographic and clinical information, self-confidence, or training time between groups. More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%]; P =0.001), power source (36/40 [90%] versus 9/40 [23%]; P <0.001), and dressing change skills (19/20 [95%] versus 0/20; P <0.001).
CONCLUSIONS
SBML provided superior VAD self-care skills learning outcomes compared with usual training. This study has important implications for patients due to the morbidity and mortality associated with improper VAD self-care.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT03073005.",2019,"More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%]; P =0.001), power source (36/40 [90%] versus 9/40 [23%]; P <0.001), and dressing change skills (19/20 [95%] versus 0/20; P <0.001).
","['Assist Device Self-Care Skills', 'Forty participants completed the study in each group', 'VAD patients and their caregivers']","['Simulation-Based Mastery Learning', 'VAD simulation-based mastery learning (SBML) self-care training curriculum with usual VAD self-care training', 'SBML or usual training during their implant hospitalization', 'usual training group completed the existing institutional VAD self-care teaching protocol']","['dressing change skills', 'demographic and clinical information, self-confidence, total participant training time, and skills performance', 'demographic and clinical information, self-confidence, or training time']","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",40.0,0.0660624,"More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%]; P =0.001), power source (36/40 [90%] versus 9/40 [23%]; P <0.001), and dressing change skills (19/20 [95%] versus 0/20; P <0.001).
","[{'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Barsuk', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Wilcox', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Elaine R', 'Initials': 'ER', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Harap', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Kerry B', 'Initials': 'KB', 'LastName': 'Shanklin', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Grady', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Gretchen P', 'Initials': 'GP', 'LastName': 'Nonog', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Schulze', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Jirak', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Diane B', 'Initials': 'DB', 'LastName': 'Wayne', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Kenzie A', 'Initials': 'KA', 'LastName': 'Cameron', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005794']
3758,32026745,Refining an algorithm-powered just-in-time adaptive weight control intervention: A randomized controlled trial evaluating model performance and behavioral outcomes.,"Suboptimal weight losses are partially attributable to lapses from a prescribed diet. We developed an app (OnTrack) that uses ecological momentary assessment to measure dietary lapses and relevant lapse triggers and provides personalized intervention using machine learning. Initially, tension between user burden and complete data was resolved by presenting a subset of lapse trigger questions per ecological momentary assessment survey. However, this produced substantial missing data, which could reduce algorithm performance. We examined the effect of more questions per ecological momentary assessment survey on algorithm performance, app utilization, and behavioral outcomes. Participants with overweight/obesity ( n = 121) used a 10-week mobile weight loss program and were randomized to OnTrack-short (i.e. 8 questions/survey) or OnTrack-long (i.e. 17 questions/survey). Additional questions reduced ecological momentary assessment adherence; however, increased data completeness improved algorithm performance. There were no differences in perceived effectiveness, app utilization, or behavioral outcomes. Minimal differences in utilization and perceived effectiveness likely contributed to similar behavioral outcomes across various conditions.",2020,"There were no differences in perceived effectiveness, app utilization, or behavioral outcomes.",['Participants with overweight/obesity ( n \u2009=\u2009121'],"['10-week mobile weight loss program', 'Refining an algorithm-powered just-in-time adaptive weight control intervention']","['algorithm performance, app utilization, and behavioral outcomes', 'ecological momentary assessment adherence', 'Suboptimal weight losses', 'perceived effectiveness, app utilization, or behavioral outcomes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0002045'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}]","[{'cui': 'C0002045'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.053029,"There were no differences in perceived effectiveness, app utilization, or behavioral outcomes.","[{'ForeName': 'Stephanie P', 'Initials': 'SP', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'The Warren Alpert Medical School of Brown University, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'WW (Weight Watchers), USA; University of Pennsylvania, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Turner-McGrievy', 'Affiliation': 'University of South Carolina, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Drexel University, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Herbert', 'Affiliation': 'University of New England, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Drexel University, USA.'}]",Health informatics journal,['10.1177/1460458220902330']
3759,31909561,What is a clinically meaningful change in exhaled nitric oxide for children with asthma?,"INTRODUCTION
Fractional exhaled nitric oxide (F E NO) may be a useful objective measurement to guide asthma treatment. What remains uncertain is what change in F E NO is clinically significant.
METHODS
An individual patient data analysis was performed using data from seven randomized clinical trials which used F E NO to guide asthma treatment. The absolute and percentage intra-subject change in F E NO measurements over ""stable"" and also ""unstable"" 3-month periods were described.
RESULTS
Data were available in 1112 randomized controlled trial participants and ≥1 stable period was present for 665 individuals. The interquartile range (IQR) and limits of agreement (LoA) for change in absolute F E NO among individuals whose initial F E NO was <50 parts per billion (ppb) were -7 to +9 ppb and -43 to +50 ppb, and for those with initial F E NO ≥50 ppb IQR was -29 to +17 ppb and LoA was -80 to +76 ppb. For percentage change in F E NO, the IQR and LoA for individuals whose initial F E NO was <50 ppb were -33% to +51% and -157% to +215%, and for those with initial F E NO ≥50 ppb were -33% to +35% and -159% to +192%. The variation in F E NO values for a stable period was similar irrespective of whether it was followed by a stable or unstable period.
CONCLUSIONS
Over a 3-month period where F E NO is initially <50 ppb, a rise of <10 ppb or of <50% (based on IQR) is unlikely to be related to asthma. When F E NO is initially ≥50 ppb an percentage change of <50% (based on IQR) is unlikely to be asthma-related.",2020,"The variation in F E NO values for a stable period was similar irrespective of whether it was followed by a stable or unstable period.
","['individuals', 'Data were available in 1112 randomized controlled trial participants and ≥1 stable period was present for 665 individuals', 'children with asthma']",[],['interquartile range (IQR) and limits of agreement (LoA'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",[],"[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0023923', 'cui_str': 'Loa'}]",1112.0,0.0298139,"The variation in F E NO values for a stable period was similar irrespective of whether it was followed by a stable or unstable period.
","[{'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Fielding', 'Affiliation': 'Medical Statistics Team, Institute of Applied Health Sciences, University of Aberdeen, UK.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Pijnenburg', 'Affiliation': ""Department of Paediatric Respiratory Medicine and Allergology, Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'de Jongste', 'Affiliation': ""Department of Paediatric Respiratory Medicine and Allergology, Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'Clinical and Experimental Science Academic Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Clinical and Experimental Science Academic Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Petsky', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland's Children's Hospital, Queensland University of Technology, Brisbane, Australia.""}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland's Children's Hospital, Queensland University of Technology, Brisbane, Australia.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fritsch', 'Affiliation': ""University Children's Hospital, Vienna, Austria.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Frischer', 'Affiliation': ""University Children's Hospital, Vienna, Austria.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Szefler', 'Affiliation': ""Department of Pediatrics, Breathing Institute, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gergen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Paediatrics, Hôpital Erasme, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Vael', 'Affiliation': 'Department of Paediatrics, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Child Health, University of Aberdeen, UK.'}]",Pediatric pulmonology,['10.1002/ppul.24630']
3760,28950305,"A randomized, phase 2 study of cetuximab plus cisplatin with or without paclitaxel for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.","Background
B490 (EudraCT# 2011-002564-24) is a randomized, phase 2b, noninferiority study investigating the efficacy and safety of first-line cetuximab plus cisplatin with/without paclitaxel (CetCis versus CetCisPac) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Patients and methods
Eligible patients had confirmed R/M SCCHN (oral cavity/oropharynx/larynx/hypopharynx/paranasal sinus) and no prior therapy for R/M disease. Cetuximab was administered on day 1 (2-h infusion, 400 mg/m2), then weekly (1-h infusions, 250 mg/m2). Cisplatin was given as a 1-h infusion (CetCis arm: 100 mg/m2; CetCisPac arm: 75 mg/m2) on day 1 of each cycle for a maximum of six cycles. Paclitaxel was administered as a 3-h infusion (175 mg/m2) on day 1 of each cycle. After six cycles, maintenance cetuximab was administered until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). We assumed a noninferiority margin of 1.40 as compatible with efficacy.
Results
A total of 201 patients were randomized 1 : 1 to each regimen; 191 were assessable. PFS with CetCis (median, 6 months) was noninferior to PFS with CetCisPac (median, 7 months) [HR for CetCis versus CetCisPac 0.99; 95% CI: 0.72-1.36, P = 0.906; margin of noninferiority (90% CI of 1.4) not reached]. Median overall survival was 13 versus 11 months (HR = 0.77; 95% CI: 0.53-1.11, P = 0.117). The overall response rates were 41.8% versus 51.7%, respectively (OR = 0.69; 95% CI: 0.38-1.20, P = 0.181). Grade ≥3 adverse event rates were 76% and 73% for CetCis versus CetCisPac, respectively, while grade 4 toxicities were lower in the two-drug versus three-drug arm (14% versus 33%, P = 0.015). No toxic death or sepsis were reported and cardiac events were negligible (1%).
Conclusion
The two-drug CetCis regimen proved to be noninferior in PFS to a three-drug combination with CetCisPac. The median OS of both regimens is comparable with that observed in EXTREME, while the life-threatening toxicity rate appeared reduced.
Clinical trial number
EudraCT# 2011-002564-24.",2017,"Median overall survival was 13 versus 11 months (HR = 0.77; 95% CI: 0.53-1.11, P = 0.117).","['Patients and methods\n\n\nEligible patients had confirmed R/M SCCHN (oral cavity/oropharynx/larynx/hypopharynx/paranasal sinus) and no prior therapy for R/M disease', 'patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN', '201 patients were randomized 1\xa0:\xa01 to each regimen; 191 were assessable', 'patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck']","['Cetuximab', 'first-line cetuximab plus cisplatin with/without paclitaxel (CetCis versus CetCisPac', 'Paclitaxel', 'Cisplatin', 'cetuximab plus cisplatin with or without paclitaxel']","['cardiac events', 'progression-free survival (PFS', 'median OS', 'overall response rates', 'Grade\u2009≥3 adverse event rates', 'life-threatening toxicity rate', 'toxic death or sepsis', 'efficacy and safety', 'grade 4 toxicities', 'Median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0226896', 'cui_str': 'Cavitas Oris'}, {'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0020629', 'cui_str': 'Laryngopharynx'}, {'cui': 'C0030471', 'cui_str': 'Paranasal Sinuses'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",201.0,0.171686,"Median overall survival was 13 versus 11 months (HR = 0.77; 95% CI: 0.53-1.11, P = 0.117).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bossi', 'Affiliation': 'Head and Neck Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan University of Milan, Milan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Clinical Epidemiology and Trial Organization, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Locati', 'Affiliation': 'Head and Neck Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan University of Milan, Milan.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ferrari', 'Affiliation': 'Medical Oncology, Ospedale San Paolo, Milan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vecchio', 'Affiliation': 'Medical Oncology, IRCCS San Martino, IST National Cancer Institute, Genova and University of Genova, Genova.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Moretti', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Denaro', 'Affiliation': 'Medical Oncology, St. Croce & Carle University Teaching Hospital, and ARCO Foundation, Cuneo.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Caponigro', 'Affiliation': 'Medical Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione Pascale, Naples.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Airoldi', 'Affiliation': '2nd Medical Oncology Division, Città della Salute e della Scienza Hospital of Turin, Turin.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Moro', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vaccher', 'Affiliation': 'Medical Oncology, Centro di Riferimento Oncologico, Aviano.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sponghini', 'Affiliation': 'Medical Oncology, A.O. Universitaria Maggiore della Carità, Novara.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caldara', 'Affiliation': 'Medical Oncology, Ospedale Santa Chiara, Trento.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rinaldi', 'Affiliation': 'Medical Oncology, AOU Policlinico ""Paolo Giaccone,"" Palermo.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ferrau', 'Affiliation': 'Medical Oncology, Ospedale San Vincenzo, Taormina.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nolè', 'Affiliation': 'Medical Oncology, Istituto Europeo di Oncologia, Milan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lo Vullo', 'Affiliation': 'Clinical Epidemiology and Trial Organization, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Tettamanzi', 'Affiliation': 'Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hollander', 'Affiliation': 'Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head and Neck Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan University of Milan, Milan. Electronic address: lisa.licitra@istitutotumori.mi.it.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx439']
3761,32032954,Short- and long-term cognitive effects of deep brain stimulation in the caudal zona incerta versus best medical treatment in patients with Parkinson's disease.,"OBJECTIVE
A growing number of studies are showing positive effects of deep brain stimulation (DBS) in the caudal zona incerta (cZi) in various tremor disorders, as well as motor symptoms of Parkinson's disease (PD). The focus of the present study was to evaluate short- and long-term cognitive effects of bilateral cZi DBS in patients with PD.
METHODS
Twenty-five nondemented patients with advanced PD were recruited to participate in a randomized trial of cZi DBS versus best medical treatment (BMT). The patients in the BMT group were offered surgery after 6 months. Neuropsychological evaluations focusing on assessing verbal and visuospatial memory, attention, and executive function were conducted at baseline and at 6 and 24 months after surgery. Self-reported measures of depression, anxiety, and change in ""frontal"" behaviors were also completed at all assessment points.
RESULTS
Bilateral cZi DBS in patients with PD generated few adverse cognitive effects. At the short-term follow-up after 6 months, no differences were found between patients randomized to BMT and patients randomized to DBS with regard to most of the cognitive domains assessed. A transient improvement in anxiety was, however, found in the surgical group. At the long-term follow-up 24 months after cZi DBS, no major changes in global cognitive functioning were found, although a decline in attention and self-reported executive function was noted.
CONCLUSIONS
With the exception of a decline in attention and self-reported executive function, bilateral cZi DBS for PD in appropriately screened patients appears to be generally safe with regard to cognitive function, both in the short- and long-term perspective.",2020,"At the long-term follow-up 24 months after cZi DBS, no major changes in global cognitive functioning were found, although a decline in attention and self-reported executive function was noted.
","['patients with PD', 'Twenty-five nondemented patients with advanced PD', ""patients with Parkinson's disease""]","['Bilateral cZi', 'bilateral cZi DBS', 'DBS', 'BMT', 'deep brain stimulation', 'cZi DBS versus best medical treatment (BMT', 'deep brain stimulation (DBS']","['verbal and visuospatial memory, attention, and executive function', 'global cognitive functioning', 'attention and self-reported executive function', 'depression, anxiety, and change in ""frontal"" behaviors', 'anxiety', 'adverse cognitive effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",25.0,0.0355494,"At the long-term follow-up 24 months after cZi DBS, no major changes in global cognitive functioning were found, although a decline in attention and self-reported executive function was noted.
","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Philipson', 'Affiliation': '1Department of Pharmacology and Clinical Neuroscience, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Patric', 'Initials': 'P', 'LastName': 'Blomstedt', 'Affiliation': '1Department of Pharmacology and Clinical Neuroscience, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fredricks', 'Affiliation': '1Department of Pharmacology and Clinical Neuroscience, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hariz', 'Affiliation': '1Department of Pharmacology and Clinical Neuroscience, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Stenmark Persson', 'Affiliation': '1Department of Pharmacology and Clinical Neuroscience, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': '2Unit of Functional Neurosurgery, UCL Institute of Neurology, London, United Kingdom; and.'}]",Journal of neurosurgery,['10.3171/2019.12.JNS192654']
3762,31977625,"Synergistic effect of the association between lidocaine and magnesium sulfate on peri-operative pain after mastectomy: A randomised, double-blind trial.","BACKGROUND
Recently, the use of venous adjuvants, such as lidocaine and magnesium sulfate, has been gaining ground in multimodal analgesia. However, no study has evaluated the impact a combination of the two drugs.
OBJECTIVES
To evaluate the efficacy of venous adjuvants in reducing opioid consumption and pain scores after mastectomy.
DESIGN
Randomised, double-blind, parallel-group, noninferiority clinical trial with a 1 : 1 : 1 : 1 allocation ratio.
SETTING
Hospital de Base do Distrito Federal, Brasilia, Federal District, Brazil from November 2014 to December 2017.
PATIENTS
One-hundred and ninety-eight patients were electively scheduled for mastectomy. Seventy-eight were excluded.
INTERVENTIONS
Intra-operative infusions of remifentanil (0.1 μg kg min), lidocaine (3 mg kg h), magnesium sulfate (50 mg kg + 15 mg kg h) or lidocaine with magnesium sulfate were used. All patients received standard general anaesthesia.
MAIN OUTCOME MEASURES
Peri-operative opioid consumption and pain scores.
RESULTS
The patients who received both lidocaine and magnesium sulfate group (n=30) consumed less alfentanil during surgery (P < 0.001) and less dipyrone (P < 0.001) and morphine (P < 0.001) in the postoperative period. Only two patients (6.7%) in the lidocaine and magnesium sulfate group needed morphine (P < 0.001). These requirements were significantly lower when compared with patients who received remifentanil (n=30; 76.6%) and magnesium sulfate (n=30; 70%; odds ratio 46.0, 95% confidence interval 8.69 to 243.25, P < 0.001, and odds ratio 32.66, 95% confidence interval 6.37 to 167.27, P < 0.001, respectively). The patients of the lidocaine and magnesium sulfate group had lower pain scores in the first 24 h postoperatively using the numerical rating scale and verbal rating scale at discharge from the postanaesthesia care unit (P < 0.001), after 12 h (P < 0.001) and after 24 h (P < 0.001) when compared with the other three groups.
CONCLUSION
Our findings suggest a synergistic effect of the use of both lidocaine and magnesium in peri-operative pain. This may be another potential strategy in the multimodal analgesia regimen.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02309879.",2020,"The patients of the lidocaine and magnesium sulfate group had lower pain scores in the first 24 h postoperatively using the numerical rating scale and verbal rating scale at discharge from the postanaesthesia care unit (P < 0.001), after 12 h (P < 0.001) and after 24 h (P < 0.001) when compared with the other three groups.
","['Seventy-eight were excluded', 'One-hundred and ninety-eight patients were electively scheduled for mastectomy', 'Hospital de Base', 'peri-operative pain after mastectomy']","['lidocaine', 'morphine', 'lidocaine with magnesium sulfate', 'remifentanil', 'lidocaine and magnesium sulfate', 'alfentanil', 'lidocaine and magnesium', 'dipyrone', 'magnesium sulfate', 'standard general anaesthesia']","['numerical rating scale and verbal rating scale', 'lower pain scores', 'opioid consumption and pain scores', 'Peri-operative opioid consumption and pain scores']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C3714569', 'cui_str': 'METAMIZOLE SODIUM'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0222045'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale (assessment scale)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",198.0,0.484793,"The patients of the lidocaine and magnesium sulfate group had lower pain scores in the first 24 h postoperatively using the numerical rating scale and verbal rating scale at discharge from the postanaesthesia care unit (P < 0.001), after 12 h (P < 0.001) and after 24 h (P < 0.001) when compared with the other three groups.
","[{'ForeName': 'Fabricio T', 'Initials': 'FT', 'LastName': 'Mendonça', 'Affiliation': 'From the Department of Anaesthesiology, Hospital de Base do Distrito Federal, Brasilia, Federal District (FTM, DP, BJG, LAC) and Cardiology Department, State University of Campinas (Unicamp), Campinas, São Paulo, Brazil (LSFC, ACS).'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Pellizzaro', 'Affiliation': ''}, {'ForeName': 'Breno J', 'Initials': 'BJ', 'LastName': 'Grossi', 'Affiliation': ''}, {'ForeName': 'Luise A', 'Initials': 'LA', 'LastName': 'Calvano', 'Affiliation': ''}, {'ForeName': 'Luiz S F', 'Initials': 'LSF', 'LastName': 'de Carvalho', 'Affiliation': ''}, {'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001153']
3763,32023381,Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.,,2020,,['Type 1 Diabetes'],['Closed-Loop Control'],[],"[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0350658,,"[{'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Takita', 'Affiliation': 'Navitas Clinic, Tokyo, Japan takita-ygc@umin.net.'}]",The New England journal of medicine,['10.1056/NEJMc1915995']
3764,32024486,Improving symptom burden in adults with persistent post-concussive symptoms: a randomized aerobic exercise trial protocol.,"BACKGROUND
Persistent post-concussive symptoms (PPCS) affect up to 30% of individuals following mild traumatic brain injury. PPCS frequently includes exercise intolerance. Sub-symptom threshold aerobic exercise has been proposed as a treatment option for symptom burden and exercise intolerance in this population. The primary aim of this study is to evaluate whether a progressive, sub-symptom threshold aerobic exercise program can alleviate symptom burden in adults with PPCS.
METHODS
Fifty-six adults (18-65) with PPCS (>3mos-5 yrs) will be randomized into two groups: an immediate start 12-week aerobic exercise protocol (AEP) or delayed start 6-week placebo-like stretching protocol (SP), followed by AEP. Aerobic or stretching activities will be completed 5x/week for 30 mins during the intervention. Online daily activity logs will be submitted. Exercise prescriptions for the AEP will be 70-80% of heart rate at the point of symptom exacerbation achieved on a treadmill test with heart rate monitoring. Exercise prescription will be updated every 3-weeks with a repeat treadmill test. The Rivermead Post-concussion Symptom Questionnaire will be the primary outcome measure at 6 and 12-weeks of intervention. Secondary outcomes include assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including γ-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA) all measured at 6 and 12-weeks of intervention.
DISCUSSION
This trial will evaluate the use of aerobic exercise as an intervention for adults with PPCS, thus expanding our knowledge of this treatment option previously studied predominantly for adolescent sport-related concussion.
TRIAL REGISTRATION
ClinicalTrials.gov - NCT03895450 (registered 2019-Feb-11).",2020,"Secondary outcomes include assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including γ-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA) all measured at 6 and 12-weeks of intervention.
","['adults with persistent post-concussive symptoms', 'adults with PPCS', 'Fifty-six adults (18-65) with PPCS (>3mos-5\u2009yrs']","['Sub-symptom threshold aerobic exercise', 'progressive, sub-symptom threshold aerobic exercise program', 'immediate start 12-week aerobic exercise protocol (AEP) or delayed start 6-week placebo-like stretching protocol (SP), followed by AEP', 'aerobic exercise', 'PPCS']","['Aerobic or stretching activities', 'exercise intolerance', 'assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including γ-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0546983', 'cui_str': 'Post-Concussion Symptoms'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220780', 'cui_str': 'Aminobutyric Acid'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl aspartate'}]",56.0,0.198792,"Secondary outcomes include assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including γ-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA) all measured at 6 and 12-weeks of intervention.
","[{'ForeName': 'Leah J', 'Initials': 'LJ', 'LastName': 'Mercier', 'Affiliation': 'Department of Clinical Neurosciences, Division of Physical Medicine and Rehabilitation, University of Calgary, Calgary, AB, Canada. leah.mercier@ucalgary.ca.'}, {'ForeName': 'Tak S', 'Initials': 'TS', 'LastName': 'Fung', 'Affiliation': 'Information Technologies, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Harris', 'Affiliation': 'Department of Radiology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Dukelow', 'Affiliation': 'Department of Clinical Neurosciences, Division of Physical Medicine and Rehabilitation, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Chantel T', 'Initials': 'CT', 'LastName': 'Debert', 'Affiliation': 'Department of Clinical Neurosciences, Division of Physical Medicine and Rehabilitation, University of Calgary, Calgary, AB, Canada.'}]",BMC neurology,['10.1186/s12883-020-1622-x']
3765,32026143,Randomised trial of two embolic agents for uterine artery embolisation for fibroids: Gelfoam versus Embospheres (RAGE trial).,"BACKGROUND
Uterine artery embolisation (UAE) is an established treatment option for women with symptomatic uterine fibroids who wish to avoid surgery. However the most efficacious embolic agent remains uncertain.
METHODS
We conducted a pilot double blind randomized controlled trial comparing Gelfoam with Embospheres in women undergoing UAE. Outcomes recorded at baseline, 24-h, 1 and 6 months included complications, inflammatory, haematological markers and ovarian function. Contrast enhanced MRI (CEMRI) was acquired at baseline, 24-h and 6 months. Pain score (visual analogue) was measured at 24-h, quality of life (UFS-Qol) at baseline, 1 and 6 months. All patients were followed to 6 months.
RESULTS
Twenty patients were randomized 1:1 to receive either Gelfoam (G) or Embospheres (E). The UFS-Qol symptom score improved in both groups at 6 months mean of 64 ± 18 to 23 ± 16 and 54 ± 15 to 32 ± 26 in the E and G groups respectively. UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively. Uterine volume at 6 months reduced from 1018 ± 666mls to 622 ± 436 (p = 0.001) and from 1026 ± 756 to 908 ± 720 (p = 0.15) in the E and G groups respectively. There was a significant difference between groups for this parameter p = 0.01. All uterine arteries were patent at 24-h and 6 months. Complete (100%) fibroid infarction rates were 5(50%) and 2(20%) in the E and G groups respectively. None of the other outcome measures showed any between group differences. There were no re-interventions in either group.
CONCLUSION
The only significant between group differences was for a greater reduction in uterine volume at 6 months in the E group. A larger trial (estimate 172 subjects) is required to determine whether other apparent differences are clinically and statistically significant.
TRIAL REGISTRATION
ISRCTN67347987.",2019,"UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.","['Twenty patients', 'uterine artery embolisation for fibroids', 'women with symptomatic uterine fibroids who wish to avoid surgery', 'women undergoing UAE']","['Uterine artery embolisation (UAE', 'Gelfoam with Embospheres', 'Gelfoam (G) or Embospheres (E', 'embolic agents']","['UFS-Qol symptom score', 'fibroid infarction rates', 'UFS-Qol HRQL', 'Uterine volume', 'complications, inflammatory, haematological markers and ovarian function', 'quality of life (UFS-Qol', 'Contrast enhanced MRI (CEMRI', 'Pain score (visual analogue', 'uterine volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C1566002', 'cui_str': 'Embospheres'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",20.0,0.257914,"UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yadavali', 'Affiliation': 'Radiology department, Gartnavel General Hospital, 1053 Great Western Rd, Glasgow, G12 OYN, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ananthakrishnan', 'Affiliation': 'Radiology department, Gartnavel General Hospital, 1053 Great Western Rd, Glasgow, G12 OYN, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'Radiology department, Gartnavel General Hospital, 1053 Great Western Rd, Glasgow, G12 OYN, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Monaghan', 'Affiliation': 'School of Mathematics and Statistics, University of Glasgow, Glasgow, G12 8QW, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McNaught', 'Affiliation': ""Clinical Research Imaging Centre, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hamoodi', 'Affiliation': 'University Department of Obstetrics and Gynaecology, Glasgow, New Lister Building, 10-16 Alexandra Parade, Glasgow, G31 2ER, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bryden', 'Affiliation': 'Radiology department, Stobhill ACH Hospital, 133 Balornock Road, Glasgow, G21 3UW, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lassman', 'Affiliation': 'Radiology department, Stobhill ACH Hospital, 133 Balornock Road, Glasgow, G21 3UW, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Moss', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, 126 University Place, Glasgow, G12 8TA, UK. j.moss@clinmed.gla.ac.uk.'}]",CVIR endovascular,['10.1186/s42155-018-0044-y']
3766,32022904,Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-REVERSE-AKI randomized controlled pilot trial.,"BACKGROUND
Fluid accumulation frequently coexists with acute kidney injury (AKI) and is associated with increased risk for AKI progression and mortality. Among septic shock patients, restricted use of resuscitation fluid has been reported to reduce the risk of worsening of AKI. Restrictive fluid therapy, however, has not been studied in the setting of established AKI. Here, we present the protocol and statistical analysis plan of the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-the REVERSE-AKI trial that compares a restrictive fluid therapy regimen to standard therapy in critically ill patients with AKI.
METHODS
REVERSE-AKI is an investigator-initiated, multinational, open-label, randomized, controlled, feasibility pilot trial conducted in seven ICUs in five countries. We aim to randomize 100 critically ill patients with AKI to a restrictive fluid treatment regimen vs standard management. In the restrictive fluid therapy regimen, the daily fluid balance target is neutral or negative. The primary outcome is the cumulative fluid balance assessed after 72 hours from randomization. Secondary outcomes include safety, feasibility, duration, and severity of AKI, and outcome at 90 days (mortality and dialysis dependence).
CONCLUSIONS
This is the first multinational trial investigating the feasibility and safety of a restrictive fluid therapy regimen in critically ill patients with AKI.
TRIAL REGISTRATION
clinical.trials.gov NCT03251131.",2020,"Secondary outcomes include safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence).
","['Acute Kidney Injury', '100 critically ill patients with AKI to a restrictive fluid treatment regimen versus standard management', 'septic shock patients', '7 ICUs in 5 countries', 'critically ill patients with AKI']",['restrictive fluid therapy regimen'],"['safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence', 'cumulative fluid balance']","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}]",100.0,0.24103,"Secondary outcomes include safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence).
","[{'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Vaara', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, King's College London, Guy's and St Thomas' Hospital, London, UK.""}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Selander', 'Affiliation': 'Science Service Center, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Elettra', 'Initials': 'E', 'LastName': 'Poli', 'Affiliation': 'Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hoste', 'Affiliation': 'Intensive Care Unit, Ghent University Hospital, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': 'Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Australian National University Medical School, Canberra, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Prowle', 'Affiliation': 'Critical Care and Preoperative Medicine Research Group, Centre for Translational Medicine and Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13557']
3767,31891298,Comparison of Patient Comfort During the First Stage of Conventional Versus Modified Two-Stage Inferior Alveolar Nerve Blocks in Pediatric Patients.,"Our aim was to compare the comfort of pediatric patients during the first stage of the conventional 2-stage inferior alveolar nerve block (IANB) versus the modified 2-stage IANB. This was a parallel group, single-blinded, randomized controlled trial. Pediatric patients meeting the inclusion criteria were randomly allocated to 1 of the 2 groups receiving IANB, group 1 (31 subjects) utilized a conventional 2-stage technique, and group 2 (33 subjects) utilized a modified 2-stage approach. Patient comfort was assessed indirectly by 2 observers using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during the first stage of the injections. FLACC score data between the 2 groups were analyzed using the chi-square test, and interobserver reliability was measured using kappa statistics. During the first stage of the injections, lower FLACC scores of 0 indicating a relaxed/comfortable patient experience were found in 57.6% of group 2 subjects compared with only 25.8% group 1 subjects, which was a statistically significant difference ( p -value .013). Interobserver reliability assessed using kappa coefficients (κ = 0.812) indicated excellent agreement. FLACC scores for the pediatric patients during the first stage of the modified 2-stage IANB technique were significantly lower than during the first stage of the conventional 2-stage IANB technique.",2019,FLACC scores for the pediatric patients during the first stage of the modified 2-stage IANB technique were significantly lower than during the first stage of the conventional 2-stage IANB technique.,"['Pediatric Patients', 'Pediatric patients meeting the inclusion criteria']","['conventional 2-stage inferior alveolar nerve block (IANB', 'Patient Comfort', 'IANB', 'conventional 2-stage technique, and group 2 (33 subjects) utilized a modified 2-stage approach']","['Face, Legs, Activity, Cry, Consolability (FLACC) scale', 'FLACC scores of 0 indicating a relaxed/comfortable patient experience', 'FLACC score data', 'FLACC scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block (procedure)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",33.0,0.0400297,FLACC scores for the pediatric patients during the first stage of the modified 2-stage IANB technique were significantly lower than during the first stage of the conventional 2-stage IANB technique.,"[{'ForeName': 'Rose Maria', 'Initials': 'RM', 'LastName': 'Joseph', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Ashwin P', 'Initials': 'AP', 'LastName': 'Rao', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Srikant', 'Affiliation': 'Department of Oral Pathology & Microbiology, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Karuna', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'P Anupama', 'Initials': 'PA', 'LastName': 'Nayak', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}]",Anesthesia progress,['10.2344/anpr-66-03-03']
3768,32022990,Tacrolimus- versus sirolimus-based immunosuppression after simultaneous pancreas and kidney transplantation: 5-year results of a randomized trial.,"Tacrolimus, the cornerstone immunosuppression after simultaneous pancreas and -kidney (SPK) transplantation, may exert nephrotoxic and diabetogenic effects. We therefore prospectively compared in an open-label, randomized, monocentric, 5-year follow-up study, a tacrolimus- and a sirolimus-based immunosuppressive regimen. Randomization using the block method allowing a blind allocation was done at the time of surgery. All patients received anti-thymocyte globulin and maintenance therapy with tacrolimus, mycophenolate mofetil, and steroids. At month 3, tacrolimus was continued or replaced by sirolimus. The primary endpoint was kidney and pancreas graft survival at 1 and 5 years. Fifty patients were included in the final analysis in each group. At 1 year, differences for kidney and pancreas graft survival between sirolimus and tacrolimus were 0% (90% confidence interval -4.61% to 4.61%) and 6% (90% confidence interval -6.32% to 18.32%), respectively. There was no difference in renal and pancreas graft survival at 5 years. Thirty-four patients (68%) in the sirolimus group vs three (6%) in the tacrolimus group needed definitive withdrawal of the study drug. Despite noninferiority of sirolimus compared to tacrolimus for kidney and pancreas graft survival, the high rate of sirolimus discontinuation does not favor its use as cornerstone therapy after SPK transplantation (NCT00693446).",2020,"At one year, difference for kidney and pancreas graft survival between sirolimus and tacrolimus were 0 % (CI 90 % [-4.61 %, 4.61 %]) and 6 % (CI 90 % [-6.32 %, 18.32 %]) respectively.","['Fifty patients were included in final analysis in each group', 'after simultaneous pancreas and kidney transplantation']","['anti-thymocyte globulin and maintenance therapy with tacrolimus, mycophenolate mofetil and steroids', 'sirolimus and tacrolimus', 'Tacrolimus- versus Sirolimus-based immunosuppression', 'sirolimus-based immunosuppressive regimen', 'sirolimus', 'Tacrolimus', 'tacrolimus']","['kidney and pancreas graft survival', 'renal and pancreas graft survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0030274', 'cui_str': 'Pancreas'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0030275', 'cui_str': 'Grafting, Pancreas'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",50.0,0.0453456,"At one year, difference for kidney and pancreas graft survival between sirolimus and tacrolimus were 0 % (CI 90 % [-4.61 %, 4.61 %]) and 6 % (CI 90 % [-6.32 %, 18.32 %]) respectively.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cantarovich', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Kervella', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Karam', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Dantal', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Blancho', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Giral', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garandeau', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Houzet', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ville', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branchereau', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Delbos', 'Affiliation': ""Laboratoire d'Histocompatibilité, Etablissement Français du Sang, EFS, Pays de la Loire, Nantes, France.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Guillot-Gueguen', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Volteau', 'Affiliation': 'Plateforme de Méthodologie et de Biostatistique, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Leroy', 'Affiliation': 'Plateforme de Méthodologie et de Biostatistique, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Renaudin', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Soulillou', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Maryvonne', 'Initials': 'M', 'LastName': 'Hourmant', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15809']
3769,24603643,"A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy.","BACKGROUND
Antiemetic guidelines recommend co-administration of agents that target multiple molecular pathways involved in emesis to maximize prevention and control of chemotherapy-induced nausea and vomiting (CINV). NEPA is a new oral fixed-dose combination of 300 mg netupitant, a highly selective NK1 receptor antagonist (RA) and 0.50 mg palonosetron (PALO), a pharmacologically and clinically distinct 5-HT3 RA, which targets dual antiemetic pathways.
PATIENTS AND METHODS
This multinational, randomized, double-blind, parallel group phase III study (NCT01339260) in 1455 chemotherapy-naïve patients receiving moderately emetogenic (anthracycline-cyclophosphamide) chemotherapy evaluated the efficacy and safety of a single oral dose of NEPA versus a single oral dose (0.50 mg) of PALO. All patients also received oral dexamethasone (DEX) on day 1 only (12 mg in the NEPA arm and 20 mg in the PALO arm). The primary efficacy end point was complete response (CR: no emesis, no rescue medication) during the delayed (25-120 h) phase in cycle 1.
RESULTS
The percentage of patients with CR during the delayed phase was significantly higher in the NEPA group compared with the PALO group (76.9% versus 69.5%; P = 0.001), as were the percentages in the overall (0-120 h) (74.3% versus 66.6%; P = 0.001) and acute (0-24 h) (88.4% versus 85.0%; P = 0.047) phases. NEPA was also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis, no significant nausea and complete protection (CR plus no significant nausea). NEPA was well tolerated with a similar safety profile as PALO.
CONCLUSIONS
NEPA plus a single dose of DEX was superior to PALO plus DEX in preventing CINV following moderately emetogenic chemotherapy in acute, delayed and overall phases of observation. As a fixed-dose antiemetic drug combination, NEPA along with a single dose of DEX on day 1 offers guideline-based prophylaxis with a convenient, single-day treatment.",2014,"NEPA was also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis, no significant nausea and complete protection (CR plus no significant nausea).",['1455 chemotherapy-naïve patients receiving moderately'],"['highly selective NK1 receptor antagonist (RA) and 0.50 mg palonosetron (PALO', 'DEX', 'NEPA', 'emetogenic (anthracycline-cyclophosphamide) chemotherapy', 'PALO plus DEX', 'PALO', 'oral dexamethasone (DEX', 'netupitant and palonosetron', 'moderately emetogenic chemotherapy']","['efficacy and safety', 'nausea and vomiting', 'complete response (CR: no emesis, no rescue medication', 'nausea and complete protection (CR plus no significant nausea']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1700730', 'cui_str': 'netupitant'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",1455.0,0.0921796,"NEPA was also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis, no significant nausea and complete protection (CR plus no significant nausea).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aapro', 'Affiliation': ""Institut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland maapro@genolier.net.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rugo', 'Affiliation': 'Comprehensive Cancer Center, University of California San Francisco, San Francisco, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': 'Corporate Clinical Development, Statistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Corporate Clinical Development, Statistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Borroni', 'Affiliation': 'Corporate Clinical Development, Statistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Department of Oncology, Dnepropetrovsk Medical Academy, Dnepropetrovsk, Ukraine.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sarosiek', 'Affiliation': 'Nzoz Magodent, Warsaw, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Oprean', 'Affiliation': 'Oncomed SRL, Timisoara, Romania.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cardona-Huerta', 'Affiliation': 'Hospital Universitario, Universidad Autonoma de Nuevo León, Monterrey, Mexico.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'National Cancer Institute Giovanni Paolo II, Bari, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Karthaus', 'Affiliation': 'Department of Hematology, Oncology and Palliative Medicine, Staedt. Klinikum Neuperlach and Harlaching, München, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'The West Clinic, Memphis.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Grunberg', 'Affiliation': 'Fletcher Allen Health Care, Burlington, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu101']
3770,31764336,"The ""Cough Trick"" Reduces Pain During Removal of Closed-suction Drains after Total Knee Arthroplasty: A Randomized Trial.","BACKGROUND
Drain removal after TKA can be painful. Prior research suggests that the ""cough trick,"" in which a patient coughs at the same time she or he receives an injection, effectively decreases pain. To our knowledge, this intervention has not been evaluated as a way to reduce pain during other brief but painful interventions, such as removal of closed-suction drains after orthopaedic surgery.
QUESTION/PURPOSE
Does the cough trick reduce pain while a surgeon is removing a closed-suction drain after TKA?
METHODS
Fifty-six patients with primary osteoarthritis who underwent primary TKA were randomized into two groups: drain removal as the patient coughed (n = 28 patients; three men, 25 women) or drain removal using the usual process, without the cough trick (n = 28 patients; three men, 25 women). The study groups were not different in terms of gender, BMI, surgical time, or other baseline variables, and other than the addition of the cough trick, there were no differences in surgical treatment or other elements of aftercare. Likewise, at baseline, the verbal numeric rating scale (VNRS) score for pain before the drain was removed was not different between the groups (3.1 ± 1.7 versus 3.3 ± 1.3; p = 0.72). The level of pain before and during drain removal was recorded using a VNRS by an orthopaedic surgeon who was not involved in the care of the study patients. We considered the minimum clinically important difference on the 10-point scale to be 2 points, based on prior evidence.
RESULTS
The mean ± SD VNRS for the pain level during drain removal was lower in the cough trick group than that in the control group (1.6 ± 1.0 versus 3.7 ± 1.9, mean difference 2.1; 95% CI, 1.3-2.9; p < 0.001).
CONCLUSIONS
The cough trick during removal of a closed-suction drain tube in patients undergoing TKA reduced the level of pain in this small randomized trial. We suggest that surgeons consider this technique when removing drains after TKA because it is a noninvasive technique and it is easy to perform. Because the cough trick has been shown by others to be effective at reducing pain during venipuncture and parenteral injections, and we found it was effective for that purpose during drain removal after TKA, we believe this finding probably generalizes well to most minor procedures that cause transient, sharp pain. We suggest that it could be used to make such procedures more comfortable for patients, as well as for drain removal in other types of surgery where drains still are commonly used (including spine surgery and tumor surgery).
LEVEL OF EVIDENCE
Level I, therapeutic study.",2019,"The mean ± SD VNRS for the pain level during drain removal was lower in the cough trick group than that in the control group (1.6 ± 1.0 versus 3.7 ± 1.9, mean difference 2.1; 95% CI, 1.3-2.9; p < 0.001).
","['n = 28 patients; three men, 25 women', 'after Total Knee Arthroplasty', 'n = 28 patients; three men, 25 women) or', 'Fifty-six patients with primary osteoarthritis who underwent primary TKA']","['drain removal as the patient coughed', 'Cough Trick"" Reduces Pain During Removal of Closed-suction Drains', 'drain removal using the usual process, without the cough trick']","['verbal numeric rating scale (VNRS) score for pain before the drain', 'level of pain', 'mean ± SD VNRS for the pain level during drain removal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1384584', 'cui_str': 'Generalized osteoarthritis (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}]",25.0,0.143798,"The mean ± SD VNRS for the pain level during drain removal was lower in the cough trick group than that in the control group (1.6 ± 1.0 versus 3.7 ± 1.9, mean difference 2.1; 95% CI, 1.3-2.9; p < 0.001).
","[{'ForeName': 'Varah', 'Initials': 'V', 'LastName': 'Yuenyongviwat', 'Affiliation': 'V. Yuenyongviwat, K. Iamthanaporn, P. Tuntarattanapong, T. Hongnaparak, Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Songkhla Thailand.'}, {'ForeName': 'Khanin', 'Initials': 'K', 'LastName': 'Iamthanaporn', 'Affiliation': ''}, {'ForeName': 'Pakjai', 'Initials': 'P', 'LastName': 'Tuntarattanapong', 'Affiliation': ''}, {'ForeName': 'Theerawit', 'Initials': 'T', 'LastName': 'Hongnaparak', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000901']
3771,31005973,"Effects of branched-chain amino acids on glucose metabolism in obese, prediabetic men and women: a randomized, crossover study.","BACKGROUND
Recent studies have shown that circulating branched-chain amino acids (BCAAs) are elevated in obese, insulin-resistant individuals. However, it is not known if supplementation of additional BCAAs will further impair glucose metabolism.
OBJECTIVES
The aim of this pilot study was to determine the effects of BCAA supplementation on glucose metabolism in obese, prediabetic individuals.
METHODS
This is a randomized crossover study involving 12 obese individuals with prediabetes. Participants were randomly assigned to receive a daily supplement containing either 20 g BCAA or protein low in BCAAs for 4 wk with a 2-wk washout in between. At each visit, an oral-glucose-tolerance test (OGTT) was performed. Collected blood samples were used to measure glucose, insulin, and insulin resistance-associated biomarkers.
RESULTS
BCAA supplementation tended to decrease the plasma glucose area under the curve (AUC) measured by the OGTT (AUC percentage change from supplementation baseline, BCAA: -3.3% ± 3%; low-BCAA: 10.0% ± 6%; P = 0.08). However, BCAA supplementation did not affect plasma insulin during OGTT challenge (BCAA: -3.9% ± 8%; low-BCAA: 14.8% ± 10%; P = 0.28). The plasma concentrations of nerve growth factor (BCAA: 4.0 ± 1 pg/mL; low-BCAA: 5.7 ± 1 pg/mL; P = 0.01) and monocyte chemoattractant protein-1 (BCAA: -0.4% ± 9%; low-BCAA: 29.0% ± 18%; P = 0.02) were significantly lowered by BCAA supplementation compared to low-BCAA control. Plasma interleukin 1β was significantly elevated by BCAA supplementation (BCAA: 231.4% ± 187%; low-BCAA: 20.6% ± 33%; P = 0.05). BCAA supplementation did not affect the circulating concentrations of the BCAAs leucine (BCAA: 9.0% ± 12%; low-BCAA: 9.2% ± 11%), valine (BCAA: 9.1% ± 11%; low-BCAA: 12.0% ± 13%), or isoleucine (BCAA: 2.5% ± 11%; low-BCAA: 7.3% ± 11%).
CONCLUSIONS
Our data suggest that BCAA supplementation did not impair glucose metabolism in obese, prediabetic subjects. Further studies are needed to confirm the results seen in the present study. This study was registered at clinicaltrials.gov as NCT03715010.",2019,Plasma interleukin 1β was significantly elevated by BCAA supplementation (BCAA: 231.4% ± 187%; low-BCAA: 20.6% ± 33%; P = 0.05).,"['obese, prediabetic men and women', 'obese, prediabetic individuals', '12 obese individuals with prediabetes', 'obese, prediabetic subjects']","['branched-chain amino acids', 'BCAA supplementation', 'daily supplement containing either 20 g BCAA or protein low in BCAAs']","['plasma concentrations of nerve growth factor', 'circulating concentrations of the BCAAs leucine', 'glucose, insulin, and insulin resistance-associated biomarkers', 'glucose metabolism', 'plasma glucose area under the curve (AUC', 'Plasma interleukin 1β', 'monocyte chemoattractant protein-1', 'plasma insulin']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}]",12.0,0.0784627,Plasma interleukin 1β was significantly elevated by BCAA supplementation (BCAA: 231.4% ± 187%; low-BCAA: 20.6% ± 33%; P = 0.05).,"[{'ForeName': 'Shih-Lung', 'Initials': 'SL', 'LastName': 'Woo', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hsu', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Ru-Po', 'Initials': 'RP', 'LastName': 'Lee', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Gilbuena', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Thames', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rasmussen', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Carpenter', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Henning', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Heber', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Molecular Medicine, Department of Anesthesiology, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Division of Molecular Medicine, Department of Anesthesiology, University of California, Los Angeles, CA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz024']
3772,31891295,An Evaluation of Ibuprofen Versus Ibuprofen/Acetaminophen for Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis.,"The purpose of this investigation was to compare ibuprofen versus an ibuprofen/acetaminophen combination for postoperative pain control in a patient model specific to teeth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis. One hundred and two patients presenting with moderate to severe pain from a maxillary or mandibular posterior tooth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis were included. Following local anesthetic administration, complete endodontic cleaning and shaping was performed. Patients were randomly assigned to receive identically appearing tablets of ibuprofen 200 mg or a combination of ibuprofen 200 mg/acetaminophen 216.7 mg with instructions to take 3 tablets every 6 hours as needed for pain. Patients were also given a prescription for an escape medication to take if the study medications did not adequately control their pain. A 4-day diary was used to record pain ratings and medication use. Moderate to severe pain was experienced by 59-61% of the patients on postoperative day 1 and 50-57% of the patients on day 2, with the pain ratings decreasing over the next 2 days. There were no statistically significant differences between the 2 groups in postoperative pain, percussion pain, or medication use. There was no difference between ibuprofen and the combination of ibuprofen/acetaminophen in the reduction of postoperative pain following endodontic debridement in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis.",2019,There was no difference between ibuprofen and the combination of ibuprofen/acetaminophen in the reduction of postoperative pain following endodontic debridement in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis.,"['One hundred and two patients presenting with moderate to severe pain from a maxillary or mandibular posterior tooth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis', 'Patients', 'patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis', 'postoperative pain control in a patient model specific to teeth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis']","['ibuprofen/acetaminophen', 'ibuprofen', 'Ibuprofen Versus Ibuprofen/Acetaminophen', 'ibuprofen/acetaminophen combination', 'ibuprofen 200 mg or a combination of ibuprofen 200 mg/acetaminophen']","['postoperative pain', 'Moderate to severe pain', 'postoperative pain, percussion pain, or medication use', 'pain ratings', 'Postoperative Endodontic Pain']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C4039735', 'cui_str': 'Symptomatic irreversible pulpitis (disorder)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C2741117', 'cui_str': 'Ibuprofen 200 MG [Ultraprin]'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}]",102.0,0.145842,There was no difference between ibuprofen and the combination of ibuprofen/acetaminophen in the reduction of postoperative pain following endodontic debridement in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis.,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Stamos', 'Affiliation': 'Former Graduate Student in Endodontics, The Ohio State University.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Drum', 'Affiliation': 'Professor and Graduate Program Director, Division of Endodontics, The Ohio State University.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Reader', 'Affiliation': 'Emeritus Professor, Division of Endodontics, The Ohio State University.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nusstein', 'Affiliation': 'Professor and Chair, Division of Endodontics, The Ohio State University.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fowler', 'Affiliation': 'Assistant Professor and Predoctoral Director, Division of Endodontics, The Ohio State University.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Beck', 'Affiliation': 'Emeritus Associate Professor, Division of Biosciences, The Ohio State University.'}]",Anesthesia progress,['10.2344/anpr-66-03-06']
3773,30738920,Diabetic neuropathies influence recovery from hip-fracture surgery in older persons with diabetes.,"BACKGROUND/OBJECTIVES
To explore the impact of diabetic peripheral neuropathy (DPN) on the recovery of older persons with diabetes mellitus (DM) after hip-fracture surgery.
DESIGN, SETTING, PARTICIPANTS
Secondary data for this study came from a clinical trial on the effectiveness of a DM-specific care model for 176 older persons (age ≥ 60) with DM over 2 years following hip-fracture surgery at a medical center in Taiwan. In the original trial, the experimental group (n = 88) received DM-specific care comprising diabetes care plus subacute care, and the control group (n = 88) received only usual care.
MEASUREMENTS
DPN was assessed using the Michigan Neuropathy Screening Instrument. Outcomes of self-care ability in activities of daily living (ADL), health-related quality of life (HRQoL), and depressive symptoms were assessed 1, 3, 6, 12, 18, 24 months following hospital discharge using the Chinese Barthel Index and Chinese-version instrumental ADL (IADL) scale; the SF-36 Taiwan version; and the Chinese-version Geriatric Depression Scale, short form, respectively.
RESULTS
After controlling for covariates, participants with DPN had 8.38 fewer points in ADL performance, 0.49 fewer points in IADL performance, and 2.33 fewer points in the physical component summary (PCS) of HRQoL than participants without DPN at 3 months following discharge. During the first year following discharge, the rate of improvement increased less for PCS (β = -0.45, p < 0.05), but more for the mental component summary (β = 0.49, p < 0.05) for those with DPN than for those without. During the second year, the rate of decline in physical function-related HRQoL increased slightly more for those with DPN than for those without (β = 0.03, p < 0.05).
CONCLUSION
DPN adversely affected ADL performance, IADL performance, and physical function-related health outcomes for older persons recovering from hip-fracture surgery. These results suggest that older patients with DM recovering from hip-fracture surgery should be assessed and managed for DPN.",2019,"During the second year, the rate of decline in physical function-related HRQoL increased slightly more for those with DPN than for those without (β = 0.03, p < 0.05).
","['176 older persons (age\u202f≥\u202f60) with DM over 2\u202fyears following hip-fracture surgery at a medical center in Taiwan', 'older persons with diabetes', 'older persons with diabetes mellitus (DM) after hip-fracture surgery', 'older patients with DM recovering from hip-fracture surgery', 'older persons recovering from hip-fracture surgery']","['diabetic peripheral neuropathy (DPN', 'hip-fracture surgery', 'DM-specific care model', 'DM-specific care comprising diabetes care plus subacute care, and the control group (n\u202f=\u202f88) received only usual care']","['rate of decline in physical function-related HRQoL', 'ADL performance, IADL performance, and physical function-related health outcomes', 'activities of daily living (ADL), health-related quality of life (HRQoL), and depressive symptoms', 'hospital discharge using the Chinese Barthel Index and Chinese-version instrumental ADL (IADL) scale; the SF-36 Taiwan version; and the Chinese-version Geriatric Depression Scale, short form, respectively']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0376635', 'cui_str': 'Post-acute Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",176.0,0.1242,"During the second year, the rate of decline in physical function-related HRQoL increased slightly more for those with DPN than for those without (β = 0.03, p < 0.05).
","[{'ForeName': 'Ming-Yueh', 'Initials': 'MY', 'LastName': 'Tseng', 'Affiliation': 'Department of Nursing, Meiho University, 23 Pingguang Road, Neipu, Pingtung 91202, Taiwan. Electronic address: x00003171@meiho.edu.tw.'}, {'ForeName': 'Yueh-Fang', 'Initials': 'YF', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, 261 Wenhwa 1st Road, Guishan District, Taoyuan 33303, Taiwan.'}, {'ForeName': 'Jersey', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'School of Public Health, University of Michigan, 1420 Washington Heights, SPH II M3007, Ann Arbor, MI 48109, USA. Electronic address: jliang@umich.edu.'}, {'ForeName': 'Jong-Shyan', 'Initials': 'JS', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Rehabilitation Science, College of Medicine, and Healthy Aging Research Center, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan; Healthy Aging Research Center, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan. Electronic address: s5492@mail.cgu.edu.tw.'}, {'ForeName': 'Ching-Tzu', 'Initials': 'CT', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan. Electronic address: ctyang1@livemail.tw.'}, {'ForeName': 'Chi-Chuan', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedic Surgery, Linkou Chang Gung Memorial Hospital, 5 Fuxing Street, Guishan District, Taoyuan 33305, Taiwan. Electronic address: ccwu@mail.cgu.edu.tw.'}, {'ForeName': 'Huey-Shinn', 'Initials': 'HS', 'LastName': 'Cheng', 'Affiliation': 'Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, 5 Fuxing Street, Guishan District, Taoyuan 33305, Taiwan. Electronic address: hscheng@adm.cgmh.org.tw.'}, {'ForeName': 'Ching-Yen', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Keelung Chang Gung Memorial Hospital, No. 200, Lane 208, Jijin 1st Road, Anle District, Keelung 20445, Taiwan.'}, {'ForeName': 'Yueh-E', 'Initials': 'YE', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Linkou Chang Gung Memorial Hospital, 5 Fuxing Street, Guishan District, Taoyuan 33305, Taiwan. Electronic address: amy436643@adm.cgmh.org.tw.'}, {'ForeName': 'Woan-Shyuan', 'Initials': 'WS', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan. Electronic address: shuan@mail.cgu.edu.tw.'}, {'ForeName': 'Yea-Ing L', 'Initials': 'YL', 'LastName': 'Shyu', 'Affiliation': 'Healthy Aging Research Center, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan; School of Nursing, College of Medicine, Chang Gung University, 259 Wenhua 1st Road, Guishan District, Taoyuan 33302, Taiwan; Department of Orthopedic Surgery, Linkou Chang Gung Memorial Hospital, 5 Fuxing Street, Guishan District, Taoyuan 33305, Taiwan; Department of Nursing, Kaohsiung Chang Gung Memorial Hospital, 123 Dapi Road, Niaosng District, Kaohsiung 83301, Taiwan; Department of Gerontology and Health Care Management, Chang Gung University of Science and Technology, 261 Wenhwa 1st Road, Guishan District, Taoyuan 33303, Taiwan. Electronic address: yeaing@mail.cgu.edu.tw.'}]",Experimental gerontology,['10.1016/j.exger.2019.02.004']
3774,32005175,Protocol of a randomized open label multicentre trial comparing continuous intrajejunal levodopa infusion with deep brain stimulation in Parkinson's disease - the INfusion VErsus STimulation (INVEST) study.,"BACKGROUND
Both Deep Brain Stimulation (DBS) and Continuous intrajejunal Levodopa Infusion (CLI) are effective therapies for the treatment of Parkinson's disease (PD). To our knowledge, no direct head-to-head comparison of DBS and CLI has been performed, whilst the costs probably differ significantly. In the INfusion VErsus STimulation (INVEST) study, costs and effectiveness of DBS and CLI are compared in a randomized controlled trial (RCT) in patients with PD, to study whether higher costs of one of the therapies are justified by superiority of that treatment.
METHODS
A prospective open label multicentre RCT is being performed, with ancillary patient preference observational arms. Patients with PD who, despite optimal pharmacological treatment, have severe response fluctuations, bradykinesia, dyskinesias, or painful dystonia are eligible for inclusion. A total of 66 patients will be randomized. There is no minimal inclusion in the patient preference arms. The primary health economic outcomes are costs per unit on the Parkinson's Disease Questionnaire-39 (PDQ-39) and costs per unit Quality-Adjusted Life Year (QALY) at 12 months. The main clinical outcome is patient-reported quality of life measured with the PDQ-39 at 12 months. Patients will additionally be followed during 36 months after initiation of the study treatment.
DISCUSSION
The INVEST trial directly compares the costs and effectiveness of the advanced therapies DBS and CLI.
TRIAL REGISTRATION
Dutch Trial Register identifier 4753, registered November 3rd, 2014; EudraCT number 2014-001501-32, Clinicaltrials.gov: NCT02480803.",2020,The primary health economic outcomes are costs per unit on the Parkinson's Disease Questionnaire-39 (PDQ-39) and costs per unit Quality-Adjusted Life Year (QALY) at 12 months.,"['Patients with PD who, despite optimal pharmacological treatment, have severe response fluctuations, bradykinesia, dyskinesias, or painful dystonia are eligible for inclusion', '66 patients', ""Parkinson's disease - the INfusion VErsus STimulation (INVEST) study"", ""Parkinson's disease (PD"", 'patients with PD']","['continuous intrajejunal levodopa infusion with deep brain stimulation', 'RCT', 'Deep Brain Stimulation (DBS) and Continuous intrajejunal Levodopa Infusion (CLI']","['quality of life', ""costs per unit on the Parkinson's Disease Questionnaire-39 (PDQ-39) and costs per unit Quality-Adjusted Life Year (QALY""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013421', 'cui_str': 'Muscle Dystonia'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}]","[{'cui': 'C0034380'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",66.0,0.101325,The primary health economic outcomes are costs per unit on the Parkinson's Disease Questionnaire-39 (PDQ-39) and costs per unit Quality-Adjusted Life Year (QALY) at 12 months.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'van Poppelen', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sisodia', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'de Haan', 'Affiliation': 'Clinical Research Unit, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'M G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Department of Neurosurgery, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Geurtsen', 'Affiliation': 'Department of Medical Psychology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'A E M', 'Initials': 'AEM', 'LastName': 'Berk', 'Affiliation': ""Dutch Parkinson's disease association (Parkinson Vereniging), Kosterijland 12, Bunnik, the Netherlands.""}, {'ForeName': 'R M A', 'Initials': 'RMA', 'LastName': 'de Bie', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Dijk', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands. j.m.dijk@amsterdamumc.nl.'}]",BMC neurology,['10.1186/s12883-020-1621-y']
3775,24631949,"A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy.","BACKGROUND
Safe, effective and convenient antiemetic regimens that preserve benefit over repeated cycles are needed for optimal supportive care during cancer treatment. NEPA, an oral fixed-dose combination of netupitant, a highly selective NK1 receptor antagonist (RA), and palonosetron (PALO), a distinct 5-HT3 RA, was shown to be superior to PALO in preventing chemotherapy-induced nausea and vomiting after a single cycle of highly (HEC) or moderately (MEC) emetogenic chemotherapy in recent trials. This study was designed primarily to assess the safety but also to evaluate the efficacy of NEPA over multiple cycles of HEC and MEC.
PATIENTS AND METHODS
This multinational, double-blind, randomized phase III study (NCT01376297) in 413 chemotherapy-naïve patients evaluated a single oral dose of NEPA (NETU 300 mg + PALO 0.50 mg) given on day 1 with oral dexamethasone (DEX). An oral 3-day aprepitant (APR) regimen + PALO + DEX was included as a control (3:1 NEPA:APR randomization). In HEC, DEX was administered on days 1-4 and in MEC on day 1. Safety was assessed primarily by adverse events (AEs), including cardiac AEs; efficacy by complete response (CR: no emesis, no rescue).
RESULTS
Patients completed 1961 total chemotherapy cycles (76% MEC, 24% HEC) with 75% completing ≥4 cycles. The incidence/type of AEs was comparable for both groups. Most frequent NEPA-related AEs included constipation (3.6%) and headache (1.0%); there was no indication of increasing AEs over multiple cycles. The majority of AEs were mild/moderate and there were no cardiac safety concerns based on AEs and electrocardiograms. The overall (0-120 h) CR rates in cycle 1 were 81% and 76% for NEPA and APR + PALO, respectively, and antiemetic efficacy was maintained over repeated cycles.
CONCLUSIONS
NEPA, a convenient single oral dose antiemetic targeting dual pathways, was safe, well tolerated and highly effective over multiple cycles of HEC/MEC.",2014,Most frequent NEPA-related AEs included constipation (3.6%) and headache (1.0%); there was no indication of increasing AEs over multiple cycles.,['413 chemotherapy-naïve patients'],"['NEPA', 'NEPA, an oral fixed-dose combination of netupitant, a highly selective NK1 receptor antagonist (RA), and palonosetron (PALO', 'NEPA (NETU 300 mg + PALO 0.50 mg) given on day 1 with oral dexamethasone (DEX', 'chemotherapy', 'HEC, DEX', 'netupitant and palonosetron', 'oral 3-day aprepitant (APR) regimen + PALO + DEX']","['nausea and vomiting', 'incidence/type of AEs', 'adverse events (AEs), including cardiac AEs; efficacy by complete response (CR: no emesis, no rescue', 'headache', 'antiemetic efficacy', 'constipation', 'CR rates']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1700730', 'cui_str': 'netupitant'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0068213', 'cui_str': 'NETU'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",,0.112653,Most frequent NEPA-related AEs included constipation (3.6%) and headache (1.0%); there was no indication of increasing AEs over multiple cycles.,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Gralla', 'Affiliation': 'Department of Medical Oncology, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, USA richard.gralla@nbhn.net.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Bosnjak', 'Affiliation': 'Department of Supportive Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Chernivtsi Regional Cancer Hospital, Chernivtsi, Ukraine.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Balser', 'Affiliation': 'OnkoNet Marburg GmbH, Marburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Department of Statistics and Data Management.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': 'Department of Corporate Clinical Development, Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Borroni', 'Affiliation': 'Department of Corporate Clinical Development, Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jordan', 'Affiliation': 'Department of Hematology and Oncology, University of Halle-Wittenberg, Halle, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu096']
3776,32019736,Comparison of efficacy of packed red blood cell transfusion based on its hemoglobin content versus the standard transfusion practice in thalassemia major patients (HEMOCON study).,"The hemoglobin (Hb) content of packed red blood cell (PRBC) units is heterogenous. The efficacy of a transfusion episode can be assessed if the Hb content of the PRBC is known and the patient's post-transfusion Hb increment is also determined. This prospective study compared the efficacy of PRBC transfusion based on its Hb content versus the standard transfusion practice. A total of 160 thalassemia major patients were enrolled and randomly divided into two equal groups: Group I (n = 80) - they received ABO/RhD identical PRBCs after determining its Hb content (≥50 g); and Group II (n = 80) - they received randomly selected ABO/RhD identical PRBCs. Hb estimation and a direct antiglobulin test were performed on the post-transfusion sample (1 h). The mean Hb content of the PRBC units was significantly higher (p = 0.000) in group I (67.86 ± 8.07 g; range: 50.80-92.13 g) than group II (60.92 ± 8.29 g; range: 40.86-86.76 g). The mean Hb increment was also significantly higher in group I patients (p = 0.04). In both the groups, there was a significant negative correlation between Hb increment and weight, age, body surface area and blood volume (p < 0.05). There was a significant positive correlation between Hb increment and Hb dose adjusted for body surface area as well as blood volume (p < 0.05). PRBC transfusion was more efficacious in patients who were transfused with PRBCs having a Hb content ≥50 g as compared to those who received randomly selected PRBCs.",2020,The mean Hb content of the PRBC units was significantly higher (p = 0.000) in group I (67.86 ± 8.07 g; range: 50.80-92.13 g) than group II (60.92 ± 8.29 g; range: 40.86-86.76 g).,"['thalassemia major patients (HEMOCON study', 'A total of 160 thalassemia major patients']","['packed red blood cell transfusion', 'ABO/RhD identical PRBCs after determining its Hb content (≥50 g); and Group II (n = 80) - they received randomly selected ABO/RhD identical PRBCs']","['hemoglobin (Hb) content of packed red blood cell (PRBC) units', 'weight, age, body surface area and blood volume', 'mean Hb increment', 'mean Hb content of the PRBC units', 'blood volume']","[{'cui': 'C0002875', 'cui_str': 'Thalassemia Major'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0199962', 'cui_str': 'Transfusion of packed red blood cells (procedure)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.013975,The mean Hb content of the PRBC units was significantly higher (p = 0.000) in group I (67.86 ± 8.07 g; range: 50.80-92.13 g) than group II (60.92 ± 8.29 g; range: 40.86-86.76 g).,"[{'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Raja', 'Affiliation': 'Department of Transfusion Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Transfusion Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. Electronic address: ashishjain16@gmail.com.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Marwaha', 'Affiliation': 'Department of Transfusion Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Trehan', 'Affiliation': 'Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis,['10.1016/j.transci.2020.102736']
3777,32005604,Effect of the ASPAN Guideline on Perioperative Hypothermia Among Patients With Upper Extremity Surgery Under General Anesthesia: A Randomized Controlled Trial.,"PURPOSE
To evaluate the effect of using the evidence-based hypothermia guideline developed by the American Society of PeriAnesthesia Nurses on body temperature, shivering, thermal discomfort and comfort, and incidence of hypothermia.
DESIGN
Randomized controlled trial with 54 patients undergoing upper arm surgery with general anesthesia in the Republic of Korea.
METHODS
Participants in the experimental group received a head turban, sleeping socks, a heated blanket, a Bair Hugger for forced-air warming, and a Mega Acer kit (ACE Medical Co, Seoul, Korea) for warming intravenous fluid. Participants in the control group received a typical hospital cotton blanket.
FINDINGS
Body temperature, shivering, thermal discomfort, and thermal comfort showed significant improvements in the experimental group compared with the control group.
CONCLUSIONS
The American Society of PeriAnesthesia Nurses guideline is applicable for preventing hypothermia under general anesthesia, which, in turn, aids in patient recovery through the suppression of various hypothermia-related complications.",2020,"FINDINGS
Body temperature, shivering, thermal discomfort, and thermal comfort showed significant improvements in the experimental group compared with the control group.
","['54 patients undergoing upper arm surgery with general anesthesia in the Republic of Korea', 'Patients With Upper Extremity Surgery Under General Anesthesia', 'Participants in the experimental group received a']","['head turban, sleeping socks, a heated blanket, a Bair Hugger for forced-air warming, and a Mega Acer kit (ACE Medical Co, Seoul, Korea) for warming intravenous fluid', 'typical hospital cotton blanket', 'ASPAN Guideline']","['Body temperature, shivering, thermal discomfort, and thermal comfort', 'Perioperative Hypothermia', 'body temperature, shivering, thermal discomfort and comfort, and incidence of hypothermia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0446516', 'cui_str': 'Brachiums'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0453970', 'cui_str': 'Turban (physical object)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445269', 'cui_str': 'Socks (physical object)'}, {'cui': 'C0179330', 'cui_str': 'Blanket, device (physical object)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0330996', 'cui_str': 'Maple'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1095832', 'cui_str': 'Cotton - textile'}, {'cui': 'C0655772', 'cui_str': 'aspan'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",54.0,0.0647667,"FINDINGS
Body temperature, shivering, thermal discomfort, and thermal comfort showed significant improvements in the experimental group compared with the control group.
","[{'ForeName': 'Sookyung', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Nursing, Nowon Eulji Medical Center, Eulji University, Nowon-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Soohyun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Eulji University (Seongnam), Gyeonggi-do, Republic of Korea. Electronic address: soohyunp@eulji.ac.kr.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.11.004']
3778,31816306,Nonopioid versus opioid analgesia after hospital discharge following cesarean delivery: a randomized equivalence trial.,"OBJECTIVE
To determine whether pain score after cesarean delivery is equivalent among women receiving outpatient nonopioid vs opioid analgesics.
STUDY DESIGN
In this trial 170 women with cesarean delivery were randomized to outpatient ibuprofen plus acetaminophen (nonopioid, n=85) or ibuprofen plus hydrocodone-acetaminophen (opioid, n=85). Primary outcome was pain score on a visual analog scale at 2-4 weeks postpartum, which was obtained from 149 (88%) women. Treatments were considered equivalent if the difference between the mean pain scores of each group and its 95% confidence interval were between -10 and 10 mm. A zero-inflated negative binomial model was used to estimate the difference between group means.
RESULTS
Treatments were not equivalent; mean pain score was lower (better) in the nonopioid group (12.3±19.5 vs 15.9±20.4 mm, adjusted mean difference, 4.8; 95% CI, -2.1 to 11.9 mm).
CONCLUSION
Pain score 2-4 weeks after cesarean delivery was lower in women receiving nonopioid analgesics.",2020,"RESULTS
Treatments were not equivalent; mean pain score was lower (better) in the nonopioid group (12.3±19.5 vs 15.9±20.4 mm, adjusted mean difference, 4.8; 95% CI, -2.1 to 11.9 mm).
","['women receiving outpatient nonopioid vs opioid analgesics', '170 women with cesarean delivery', 'after hospital discharge following cesarean delivery']","['Nonopioid versus opioid analgesia', 'ibuprofen plus acetaminophen (nonopioid, n=85) or ibuprofen plus hydrocodone-acetaminophen']","['mean pain score', 'pain score on a visual analog scale', 'pain score', 'mean pain scores', 'Pain score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0002772', 'cui_str': 'Analgesics, Opioid'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",170.0,0.515064,"RESULTS
Treatments were not equivalent; mean pain score was lower (better) in the nonopioid group (12.3±19.5 vs 15.9±20.4 mm, adjusted mean difference, 4.8; 95% CI, -2.1 to 11.9 mm).
","[{'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Dinis', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston. Electronic address: Jenifer.DinisBallestas@bcm.edu.'}, {'ForeName': 'Eleazar', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School at The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Blackwell', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Baha', 'Initials': 'B', 'LastName': 'Sibai', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.001']
3779,32014538,Effects of the Mother-Child Education Program on Parenting Stress and Disciplinary Practices Among Refugee and Other Marginalized Communities in Lebanon: A Pilot Randomized Controlled Trial.,"OBJECTIVE
Few randomized controlled trials (RCTs) have explored the implementation and impact of early childhood parenting education programs in very fragile contexts and humanitarian settings. We tested the effects of a group-based intervention, the Mother-Child Education Program (MOCEP), on parenting stress and practices among two refugee communities and one other marginalized community in Beirut, Lebanon.
METHOD
A pilot wait-list RCT was conducted to assess the program's impact on maternal, child (average age: 4 years), and dyadic outcomes. A total of 106 mother-child dyads were randomly assigned to either the intervention group (n = 53) or the wait-list control group (n = 53). Analysis was conducted by modified intention-to-treat and supplemental analyses through multiple imputation of missing post-intervention data.
RESULTS
Forty families (38%) withdrew early from the study. After completing the program, mothers in the intervention group showed a reduction in their harsh parenting practices, as indexed by the Disciplinary Style Questionnaire (Cohen's d = -0.76, 95% CI = -1.24, -0.27) and in their level of parenting stress, as indexed by the Parenting Stress Index-Short Form (PSI-SF; Cohen's d = -0.90, 95% CI = -1.39, -0.40). Exploratory but underpowered analyses of dyadic interactions revealed reductions in the PSI were associated with a reduction in harsh parenting after the intervention. However, we did not detect any positive impact on behavioral or emotional outcomes among the children.
CONCLUSION
Our analyses suggest that MOCEP had a positive impact on disciplinary practices and parenting stress in a context of high fragility, but that broader effects on maternal and child outcomes may be dependent on program attendance and the availability of other services. We discuss implications of this pilot study for practice and research of a largely unexplored area of program evaluation.
CLINICAL TRIAL REGISTRATION INFORMATION
Mother and Child Education Program in Palestinian Refugee Camps; https://clinicaltrials.gov; NCT02402556.",2020,Exploratory but underpowered analyses of dyadic interactions revealed reductions in the PSI were associated with a reduction in harsh parenting after the intervention.,"['106 mother-child dyads', 'Parenting Stress and Disciplinary Practices Among Refugee and Other Marginalized Communities in Lebanon', 'Forty families (38%) withdrew early from the study']","['wait-list control group', 'Mother-Child Education Program', 'MOCEP', 'group-based intervention, the Mother-Child Education Program (MOCEP']","['reduction in their harsh parenting', 'Disciplinary Style Questionnaire', 'behavioral and emotional status']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023190', 'cui_str': 'Lebanese Republic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",106.0,0.128697,Exploratory but underpowered analyses of dyadic interactions revealed reductions in the PSI were associated with a reduction in harsh parenting after the intervention.,"[{'ForeName': 'Liliana A', 'Initials': 'LA', 'LastName': 'Ponguta', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut. Electronic address: angelica.ponguta@yale.edu.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'Issa', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Aoudeh', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Cosette', 'Initials': 'C', 'LastName': 'Maalouf', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sascha D', 'Initials': 'SD', 'LastName': 'Hein', 'Affiliation': 'Dr. Hein is with Freie Universität Berlin, Germany.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Zonderman', 'Affiliation': 'Ms. Zonderman is with the Section of Hospital Medicine, Biological Sciences Division, The University of Chicago, Illinois.'}, {'ForeName': 'Liliya', 'Initials': 'L', 'LastName': 'Katsovich', 'Affiliation': 'Dr. Khoshnood and Ms. Katsovich are with the School of Public Health, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Khoshnood', 'Affiliation': 'Dr. Khoshnood and Ms. Katsovich are with the School of Public Health, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bick', 'Affiliation': 'Dr. Bick is with The University of Houston, Texas.'}, {'ForeName': 'Abir', 'Initials': 'A', 'LastName': 'Awar', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Nourallah', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Householder', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Moore', 'Affiliation': 'Ms. Moore is with the University of Delaware, Newark.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Salah', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Pia R', 'Initials': 'PR', 'LastName': 'Britto', 'Affiliation': 'Dr. Britto is with UNICEF, New York.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Leckman', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.12.010']
3780,31947784,Effectiveness of an Interdisciplinary Program Performed on Obese People Regarding Nutritional Habits and Metabolic Comorbidity: A Randomized Controlled Clinical Trial.,"Obesity is an important public health problem. The combined use of different therapies performed by an interdisciplinary group can improve the management of this health issue. The main goal of this research is to determine the effectiveness of a multidisciplinary program based on healthy eating, exercise, cognitive-behavioral therapy, and health education in improving metabolic comorbidity, Body Mass Index (BMI), and nutritional habits among obese adults, at short (12 months) and long term (24 months). A randomized controlled clinical trial was conducted at a community care center between February 2014 and February 2016. A random sampling was done (299), total population (3262). A sample of 74 subjects diagnosed with obesity (experimental group, n = 37 and control group, n = 37) was conducted. Inclusion criteria: obese people (BMI: >30 kg/m 2 ) with metabolic comorbidity and bad nutritional habits. Exclusion criteria: other comorbidities. A 12-month interdisciplinary program (with pre-test, 12 months and 24 months of follow-up) was applied. Intervention is based on healthy eating, exercise, and cognitive behavioral therapy. The intervention had a positive effect on nutritional habits (F2;144 = 115.305; p < 0.001). The experimental group increased fruit and vegetable intake (F2;144 = 39.604, p < 0.001), as well as fortified foods (F2;144 = 10,076, p < 0.001) and reduced fats, oils, and sweets F2;144 = 24,086, p < 0.001). In the experimental group, a BMI reduction of 2.6 to 24 months was observed. At follow-up, no participant had inadequate nutritional habits, compared to 35.1% of the control group (χ22 = 33,398; p < 0.001). There was also a positive response of metabolic comorbidities in the intervention group. The interdisciplinary program improved all participants' metabolic parameters, BMI, and nutritional habits while maintaining the long-term effects (24 months).",2020,"The experimental group increased fruit and vegetable intake (F2;144 = 39.604, p < 0.001), as well as fortified foods (F2;144 = 10,076, p < 0.001) and reduced fats, oils, and sweets","['Inclusion criteria: obese people (BMI: >30 kg/m 2 ) with metabolic comorbidity and bad nutritional habits', 'Obese People', '74 subjects diagnosed with obesity (experimental group, n = 37 and control group, n = 37', 'obese adults, at short (12 months) and long term (24 months', 'community care center between February 2014 and February 2016']","['multidisciplinary program based on healthy eating, exercise, cognitive-behavioral therapy, and health education', 'Interdisciplinary Program']","['metabolic parameters, BMI, and nutritional habits while maintaining the long-term effects', 'Nutritional Habits and Metabolic Comorbidity', 'inadequate nutritional habits', 'metabolic comorbidity, Body Mass Index (BMI), and nutritional habits', 'nutritional habits', 'positive response of metabolic comorbidities', 'fruit and vegetable intake', 'reduced fats, oils, and sweets', 'BMI reduction']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0018701'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0023983', 'cui_str': 'Effects, Long-Term'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",74.0,0.0298992,"The experimental group increased fruit and vegetable intake (F2;144 = 39.604, p < 0.001), as well as fortified foods (F2;144 = 10,076, p < 0.001) and reduced fats, oils, and sweets","[{'ForeName': 'Virginia Esperanza', 'Initials': 'VE', 'LastName': 'Fernández-Ruiz', 'Affiliation': 'Nutrition Department, Hospital Clínico Universitario Virgen de la Arrixaca, 30120 El Palmar, Spain.'}, {'ForeName': 'Antonio Jesús', 'Initials': 'AJ', 'LastName': 'Ramos-Morcillo', 'Affiliation': 'Department of Nursing, Faculty of Nursing, University of Murcia, 30100 Espinardo, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Solé-Agustí', 'Affiliation': 'Murcian Health Service, 30008 Murcia, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Paniagua-Urbano', 'Affiliation': 'Murcian Health Service, 30008 Murcia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Armero-Barranco', 'Affiliation': 'Department of Nursing, Faculty of Nursing, University of Murcia, 30100 Espinardo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17010336']
3781,31947813,Effect of Parental Migration on the Intellectual and Physical Development of Early School-Aged Children in Rural China.,"OBJECTIVE
The purpose of this study is to estimate the effect of parent migration on intellectual and physical development of early school-aged children in rural China.
DESIGN
setting and participants: The present cross-sectional study participants were a subset from a controlled, cluster-randomized, double-blind trial. From October 2012 to September 2013, the offspring of women who participated in a large trial were examined in the present study. Wechsler intelligence scale for children (WISC-IV) in which validity and reliability were shown to be satisfactory was used to measure the intellectual function and trained anthropometrists measured weight and height of children using standard procedures.
RESULTS
The mean difference of FSIQ scores between non-migration and both-parent migration groups was -3.68 (95%CI: -5.49, -1.87). After adjusting for the confounders, the mean difference of full-scale IQ between non-migration and both-parent migration group was -1.97 (95%CI: -3.92, -0.01), the mean differences of perceptual reasoning index and processing speed index were -2.41 (95%CI: -4.50, -0.31) and -2.39 (95%CI: -4.42, -0.35) between two groups respectively.
CONCLUSION
Our results emphasized the impairment of both-parental migration in intellectual function (FSIQ, PRI, PSI) of children. These findings have important policy implications for the Chinese government to prevent the impairment of left-behind children. Further research is required to clarify the mechanisms by which both-parental migration influence the impairment in intellectual function of children.",2020,The mean difference of FSIQ scores between non-migration and both-parent migration groups was -3.68,"['early school-aged children in rural China', 'setting and participants', 'children (WISC-IV', 'From October 2012 to September 2013, the offspring of women who participated in a large trial', 'Early School-Aged Children in Rural China']","['parent migration', 'Parental Migration', '95%CI']","['full-scale IQ', 'FSIQ scores', 'Wechsler intelligence scale', 'Intellectual and Physical Development', 'perceptual reasoning index and processing speed index']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0204457', 'cui_str': 'WISC-V'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}]","[{'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043089', 'cui_str': 'Wechsler Intelligence Scales'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}]",,0.104499,The mean difference of FSIQ scores between non-migration and both-parent migration groups was -3.68,"[{'ForeName': 'Minmin', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.""}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Zhu', 'Affiliation': ""Department of Communicable Disease Control and Prevention, Shaanxi Provincial Center for Disease Control and Prevention, Xi'an 710054, China.""}, {'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.""}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Shaonong', 'Initials': 'S', 'LastName': 'Dang', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Watson', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Zhongqiu', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': ""Department of Nursing, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.""}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.""}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.""}]",International journal of environmental research and public health,['10.3390/ijerph17010339']
3782,32005419,"Evaluation of Femaxeen® for control of urinary incontinence in women: A randomized, double-blind, placebo-controlled study.","BACKGROUND AND AIMS
Urinary incontinence (UI) is common in women, with up to 50 % experiencing involuntary loss of urine at some point. Femaxeen®, a formulation containing purified and specific cytoplasmic extracts of pollen, pumpkin seed extract and vitamin E (referred to hereafter as Femaxeen), is indicated for control of UI in women. This study investigated the efficacy and safety of Femaxeen for the prevention and treatment of UI symptoms in women.
METHODS
In this randomized, double-blind, placebo-controlled trial, 81 women with moderate, severe, or very severe urge (43.4 %), stress (31.6 %) or mixed (25.0 %) UI were allocated to receive Femaxeen or placebo once daily for 90 days. Treatment efficacy was assessed using three validated questionnaires.
FINDINGS
Thirty-eight patients per group were analyzed. Femaxeen produced statistically significant improvements from baseline to Day 90 (p < 0.001 for all comparisons) in scores on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Measurement of Urinary Handicap (MHU) questionnaire, and Sandvik Incontinence Severity Index. Reduction from baseline in ICIQ-SF and MHU scores at Day 60 and Day 90 was significantly greater with Femaxeen than placebo (p < 0.05 for all comparisons). Femaxeen significantly reduced ICIQ-SF and MHU scores from baseline to Day 60 and Day 90 in all UI types (p < 0.05 for all comparisons except ICIQ-SF scores for stress UI). Femaxeen and placebo were well tolerated. Associated adverse events were few and mild in intensity.
CONCLUSIONS
Femaxeen is effective for treating UI, and has a safety profile comparable to that of placebo.",2020,"Femaxeen produced statistically significant improvements from baseline to Day 90 (p < 0.001 for all comparisons) in scores on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF),","['urinary incontinence in women', '81 women with moderate, severe, or very severe urge (43.4 %), stress (31.6 %) or mixed (25.0 ', 'UI symptoms in women']","['Femaxeen®, a formulation containing purified and specific cytoplasmic extracts of pollen, pumpkin seed extract and vitamin E', 'Femaxeen®', 'Femaxeen and placebo', 'placebo', 'Femaxeen', 'Femaxeen or placebo']","['efficacy and safety', 'Incontinence Questionnaire-Short Form (ICIQ-SF', 'Measurement of Urinary Handicap (MHU) questionnaire, and Sandvik Incontinence Severity Index', 'Treatment efficacy', 'ICIQ-SF and MHU scores', 'tolerated', 'adverse events']","[{'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0032385', 'cui_str': 'Pollen Grains'}, {'cui': 'C0459821', 'cui_str': 'Pumpkin seed extract'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",81.0,0.539654,"Femaxeen produced statistically significant improvements from baseline to Day 90 (p < 0.001 for all comparisons) in scores on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF),","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': ""Palacios Institute of Women's Health, Madrid, Spain. Electronic address: spalacios@institutopalacios.com.""}, {'ForeName': 'Marieta', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': ""Palacios Institute of Women's Health, Madrid, Spain.""}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Lilue', 'Affiliation': ""Palacios Institute of Women's Health, Madrid, Spain.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Vega', 'Affiliation': 'Medical Department, Sérélys Pharma, Fontvieille, Monaco.'}]",Maturitas,['10.1016/j.maturitas.2019.12.008']
3783,32005642,Mindfulness-Based Cognitive Therapy for Improving Subjective Well-Being Among Healthy Individuals: Protocol for a Randomized Controlled Trial.,"BACKGROUND
Previous studies have indicated that higher subjective well-being works as a protective factor for health. Some studies have already shown the effects of mindfulness-based interventions on improving subjective well-being. However, these studies targeted specific populations rather than the general public. Furthermore, they assessed either life evaluation or affective aspects of subjective well-being rather than the concept as a whole, including the eudemonic aspect of well-being.
OBJECTIVE
This study aims to investigate the effectiveness and cost-effectiveness of mindfulness-based cognitive therapy (MBCT) for improving the wholistic aspects of subjective well-being in healthy individuals.
METHODS
This study was an 8-week, randomized, parallel-group, superiority trial with a 2-month follow-up. Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale (SWLS) were eligible to participate and randomly allocated to the MBCT group or the wait-list control group. The intervention program was developed by modifying an MBCT program to improve the well-being of a nonclinical population. The primary outcome was the difference between the two groups in mean change scores from the baseline on the SWLS. The secondary outcomes included scores on the Flourishing Scale and the Scale of Positive and Negative Experience as well as the incremental cost-effectiveness ratio.
RESULTS
This study began recruiting participants in July 2018 and recruitment was completed at the end of September 2019. Data collection and dataset construction was completed by the end of March 2020.
CONCLUSIONS
This study is unique in that it investigates MBCT's effects on the three different aspects of subjective well-being: life evaluation, affect, and eudemonia. It is limited, as the specific effect attributable to MBCT cannot be detected because of the lack of an active control group.
TRIAL REGISTRATION
University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000031885; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036376.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/15892.",2020,"Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale will be eligible participants and randomly allocated to MBCT, or wait-list control.","['healthy individuals', 'Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale will be eligible participants', 'participants in July 2018']","['Mindfulness-Based Cognitive Therapy', 'Mindfulness Based Cognitive Therapy (MBCT', 'MBCT, or wait-list control']","['Flourishing Scale, Scale of Positive and Negative Experience, Incremental Cost Effectiveness Ratio etc', 'Effectiveness and cost effectiveness', 'mean change scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale (assessment scale)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0222045'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0485996,"Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale will be eligible participants and randomly allocated to MBCT, or wait-list control.","[{'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Sado', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Kosugi', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ninomiya', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Nagaoka', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Sunre', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Faculty of Nursing and Medicine Care, Keio University, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Fujisawa', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Joichiro', 'Initials': 'J', 'LastName': 'Shirahase', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}]",JMIR research protocols,['10.2196/15892']
3784,32006071,Impact of an informational flipchart on lifestyle advice for Nepali women with a pelvic organ prolapse: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS
Pelvic floor muscle training (PFMT) and lifestyle advice are effective at improving the symptoms and severity of pelvic organ prolapse (POP) in a range of populations; however, the impact of these interventions in Nepali women is unknown. We aimed to evaluate the impact of an informational flipchart on PFMT and lifestyle advice on the quality of life (QOL) for Nepali women with a POP.
METHODS
This prospective randomized controlled trial recruited 140 women with a stage I-III POP from Kathmandu Valley. The intervention group were instructed on PFMT and lifestyle advice through an informational flipchart and the control group were provided usual care. The primary outcome measure was the Prolapse Quality of Life questionnaire (P-QOL) and was completed at baseline, 6 weeks, 12 weeks and 6 months. The secondary outcome measure was the Pelvic Organ Prolapse Quantification (POP-Q) system and Modified Oxford Scale (MOS) assessed by clinical examination at baseline and 6 months. Differences in mean P-QOL scores for each domain were evaluated using analysis of covariance.
RESULTS
Compared with usual care, the women in the informational flipchart group experienced significant improvement in six of the nine P-QOL domains and for the prolapse, bladder and bowel symptoms. Only a small percentage (20%) of women were able to attend the 6-month clinical assessment so we were unable to assess the secondary outcomes.
CONCLUSIONS
A one-time intervention of an informational flipchart on PFMT and lifestyle advice is effective at improving QOL and symptoms for Nepali women with a stage I-III POP.",2020,A one-time intervention of an informational flipchart on PFMT and lifestyle advice is effective at improving QOL and symptoms for Nepali women with a stage I-III POP.,"['Nepali women with a stage I-III POP', 'Nepali women with a pelvic organ prolapse', '140 women with a stage I-III POP from Kathmandu Valley', 'Nepali women with a POP']","['Pelvic floor muscle training (PFMT) and lifestyle advice', 'PFMT and lifestyle advice through an informational flipchart and the control group were provided usual care', 'informational flipchart on PFMT and lifestyle advice', 'informational flipchart']","['quality of life (QOL', 'QOL and symptoms', 'Prolapse Quality of Life questionnaire (P-QOL', 'nine P-QOL domains', 'Pelvic Organ Prolapse Quantification (POP-Q) system and Modified Oxford Scale (MOS) assessed by clinical examination', 'lifestyle advice', 'mean P-QOL scores', 'prolapse, bladder and bowel symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0563004', 'cui_str': 'Valley (environment)'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}]",140.0,0.135749,A one-time intervention of an informational flipchart on PFMT and lifestyle advice is effective at improving QOL and symptoms for Nepali women with a stage I-III POP.,"[{'ForeName': 'Delena', 'Initials': 'D', 'LastName': 'Caagbay', 'Affiliation': 'Discipline of Obstetrics and Gynaecology and Neonatology, The University of Sydney, Sydney, Australia. dcaa7602@uni.sydney.edu.au.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Raynes-Greenow', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Dangal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kathmandu Model Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mc Geechan', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kirsten I', 'Initials': 'KI', 'LastName': 'Black', 'Affiliation': 'Discipline of Obstetrics and Gynaecology and Neonatology, The University of Sydney, Sydney, Australia.'}]",International urogynecology journal,['10.1007/s00192-020-04228-1']
3785,32009422,Post-needling soreness and trigger point dry needling for hemiplegic shoulder pain following stroke.,"OBJECTIVES
To determine the presence of post-needling induced pain in subjects who had suffered a stroke and received trigger point (TrP) dry needling (DN), and to investigate the effects of including TrP-DN into a rehabilitation program for shoulder pain in this population.
METHODS
A randomized clinical trial was conducted. Sixteen patients who had suffered a stroke and presented with shoulder pain were randomly assigned to receive rehabilitation alone or rehabilitation combined with DN. Both groups received a neurorehabilitation session including modulatory interventions targeting the central nervous system. Patients in the DN group also received a single session of DN over active TrPs in the shoulder musculature. A numerical pain rating scale (NPRS, 0-10) was used to asses post-needling induced pain at 1 min, 24 h, and 72 h after needling. Shoulder pain (NPRS, 0-10) was assessed at baseline, and 3 and 7 days after DN in both groups.
RESULTS
Five (62%) patients receiving TrP-DN reported post-needling induced pain. Post hoc analysis found that post-needling induced pain decreased significantly at 24 and 72 h (both p < 0.001) after DN. Patients receiving TrP-DN plus rehabilitation exhibited greater decreases in shoulder pain intensity at 3 days (Δ = -4.2, 95% confidence interval (CI) = -5.8 to -2.6) and 7 days (Δ = -4.3, 95% CI = -5.9 to -2.7) after the intervention compared with those receiving rehabilitation alone (all p < 0.001).
CONCLUSION
This trial found that 50% of stroke patients receiving DN experienced post-needling induced pain, a side effect that almost disappeared 72 h after the intervention without any additional therapeutic action. In addition, the inclusion of TrP-DN into a rehabilitation session was effective at decreasing shoulder pain in these patients.",2020,Patients receiving TrP-DN plus rehabilitation exhibited greater decreases in shoulder pain intensity at 3 days (,"['hemiplegic shoulder pain following stroke', 'subjects who had suffered a stroke and received', 'Sixteen patients who had suffered a stroke and presented with shoulder pain']","['trigger point (TrP) dry needling (DN', 'TrP-DN plus rehabilitation', 'rehabilitation alone or rehabilitation combined with DN', 'TrP-DN into a rehabilitation program', 'Post-needling soreness and trigger point dry needling', 'neurorehabilitation session including modulatory interventions targeting the central nervous system']","['shoulder pain', 'shoulder pain intensity', 'pain', 'Shoulder pain (NPRS, 0-10', 'numerical pain rating scale']","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}]",16.0,0.256772,Patients receiving TrP-DN plus rehabilitation exhibited greater decreases in shoulder pain intensity at 3 days (,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Mendigutía-Gómez', 'Affiliation': 'Department of Physical Therapy-Rehabilitation, Hospital Beata María Ana, Madrid, Spain.'}, {'ForeName': 'María T', 'Initials': 'MT', 'LastName': 'Quintana-García', 'Affiliation': 'Department of Physical Therapy-Rehabilitation, Hospital Beata María Ana, Madrid, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Martín-Sevilla', 'Affiliation': 'Department of Physical Therapy-Rehabilitation, Hospital Beata María Ana, Madrid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'de Lorenzo-Barrientos', 'Affiliation': 'Instituto Nacional de Estadística, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Rodríguez-Jiménez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528419882941']
3786,32012064,"A Web-Based, Computer-Tailored Intervention to Reduce Alcohol Consumption and Binge Drinking Among Spanish Adolescents: Cluster Randomized Controlled Trial.","BACKGROUND
Alcohol consumption, including binge drinking (BD) and heavy episodic drinking (HED), is one of the leading risk factors among Spanish adolescents leading to significant social, health, and economic consequences. Reduction of BD and HED in adolescents can be achieved using Web-based, computer-tailored (CT) interventions, providing highly personalized feedback that is adapted to a person's individual characteristics and needs. Randomized controlled trials assessing the effects of tailored BD reduction programs among Spanish adolescents are scarce.
OBJECTIVE
The aim of this study was to test the effectiveness of the Web-based, CT intervention Alerta Alcohol, aimed at the prevention of BD in Spanish adolescents. As a secondary outcome, effects on HED, weekly consumption, and any consumption were also assessed. The adherence and process evaluation were assessed.
METHODS
A cluster randomized controlled trial conducted among 15 Spanish schools was developed. Each school was randomized into either an experimental condition (EC) (N=742) or a control condition (CC) (N=505). Finally, 351 participants for the EC and 261 for the CC were included in the analysis (N=612). Baseline assessment took place in January and February 2017. Demographic variables and alcohol use were assessed at baseline. Follow-up assessment of alcohol use took place 4 months later in May and June 2017. Participants were compared according to their randomization group (EC versus CC). After the baseline assessment, participants in the EC started the intervention, which consisted of short stories about BD, in which CT feedback was based on the I-Change Model for behavior change. Participants in the CC group only received the baseline questionnaire. Effects of the intervention were assessed using a three-level mixed logistic regression analysis for BD, HED, and any consumption, and a three-level mixed linear regression analysis for weekly consumption.
RESULTS
In total, 1247 adolescents participated in the baseline assessment and 612 participated in the follow-up assessment; the attrition rate was 50.92%. The intervention was effective in reducing HED among adolescents; the odds of HED in the CC was nine times that in the experimental condition (P=.04). No effects were found for BD, weekly consumption, and any consumption. Process evaluations revealed that the adolescents were satisfied with the program (68.8%), would use the program again (52.9%), and would recommend it to someone else (62.8%). Females and non-binge drinkers showed better responses in the process evaluation.
CONCLUSIONS
Our intervention was effective regarding HED but not regarding BD, weekly consumption, and any consumption. It may be that limiting alcohol consumption to prevent HED was easier in the Spanish context than it was to carry out further steps, such as reducing other patterns of alcohol consumption. Hence, additional actions are needed to accomplish these latter goals, including community approaches and policy actions aimed at denormalizing alcohol consumption among Spanish adolescents.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03288896; https://clinicaltrials.gov/ct2/show/NCT03288896.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1186/s12889-018-5346-4.",2020,"Reduction of BD and HED in adolescents can be achieved using Web-based, computer-tailored (CT) interventions, providing highly personalized feedback that is adapted to a person's individual characteristics and needs.","['Spanish adolescents', 'Females and non-binge drinkers', '1247 adolescents participated in the baseline assessment and 612 participated in the follow-up assessment; the', '351 participants for the EC and 261 for the CC were included in the analysis (N=612', '15 Spanish schools', 'Spanish Adolescents']","['tailored BD reduction programs', 'experimental condition (EC) (N=742) or a control condition (CC', 'Computer-Tailored Intervention']","['Alcohol Consumption and Binge Drinking', 'attrition rate', 'BD, weekly consumption, and any consumption', 'HED, weekly consumption, and any consumption']","[{'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517834', 'cui_str': '612 (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",1247.0,0.0517055,"Reduction of BD and HED in adolescents can be achieved using Web-based, computer-tailored (CT) interventions, providing highly personalized feedback that is adapted to a person's individual characteristics and needs.","[{'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Martinez-Montilla', 'Affiliation': 'Department of Nursing, School of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Mercken', 'Affiliation': 'Department of Health Promotion, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Math', 'Initials': 'M', 'LastName': 'Candel', 'Affiliation': 'Care and Public Health Research Institute, Maastricht, Netherlands.'}, {'ForeName': 'Joaquín Salvador', 'Initials': 'JS', 'LastName': 'Lima-Rodríguez', 'Affiliation': 'Department of Nursing, School of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lima-Serrano', 'Affiliation': 'Department of Nursing, School of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.'}]",Journal of medical Internet research,['10.2196/15438']
3787,31350778,A nurse-coordinated integrated care model to support decision-making and self-care in patients with atrial fibrillation: A study protocol.,"AIM
This study aims to evaluate the effects of a nurse-coordinated, empowerment-based integrated care model on self-care behaviours and psychosocial outcomes in patients with atrial fibrillation and to explore how this intervention affects patients' self-care behaviours and quality of life.
DESIGN
This mixed-methods study comprises a randomized controlled trial and an exploratory qualitative study.
METHODS
A total of 392 community-dwelling patients aged ≥65 years with a confirmed diagnosis of atrial fibrillation, a high stroke risk and no oral anticoagulants treatment will be recruited from the medical outpatient clinics of a university-affiliated hospital. The patients will be randomly allocated to intervention or control groups, which will receive treatment via the nurse-coordinated integrated care model or standard care, respectively. We hypothesize that compared with patients receiving standard care, atrial fibrillation patients exposed to the nurse-coordinated care model will be more likely to achieve compatible patient and physician decisions regarding the use of oral anticoagulants, better changes in medication adherence, anxiety, depression and health-related quality of life after the intervention. A subsample of 30 participants in the intervention group will also participate in a qualitative interview to provide their views and perceptions about the intervention. The ethical approval has obtained on 5 July 2018. This study is supported by a grant from the Research Grants Council of the Hong Kong Special Administrative Region on 29 June 2018.
DISCUSSION
This study will uniquely adopt an empowerment-based approach to equip patients as active agents in atrial fibrillation management through a nurse-coordinated integrated care model that comprehensively addresses their needs.
IMPACT
Patients with atrial fibrillation are currently receiving inadequate guideline-recommended care. This study will address this important evidence-practice gap by optimizing oral anticoagulant prescription and therapeutic effects and promotes effective patient self-care, so as to achieve worldwide reductions in atrial fibrillation-related morbidity, mortality, and healthcare burdens.
CLINICAL TRIAL REGISTRATION
This study has been registered at ClinicalTrials.gov (NCT03924739).",2019,"The patients will be randomly allocated to intervention or control groups, which will receive treatment via the nurse-coordinated integrated care model or standard care, respectively.","['patients receiving standard care, atrial fibrillation patients', 'Patients with atrial fibrillation', 'patients with atrial fibrillation', '392 community-dwelling patients aged ≥65\xa0years with a confirmed diagnosis of atrial fibrillation, a high stroke risk and no oral anticoagulants treatment will be recruited from the medical outpatient clinics of a university-affiliated hospital']","['nurse-coordinated, empowerment-based integrated care model']","['medication adherence, anxiety, depression and health-related quality of life', ' self-care behaviours and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",392.0,0.0376596,"The patients will be randomly allocated to intervention or control groups, which will receive treatment via the nurse-coordinated integrated care model or standard care, respectively.","[{'ForeName': 'Polly W C', 'Initials': 'PWC', 'LastName': 'Li', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Doris S F', 'Initials': 'DSF', 'LastName': 'Yu', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Bryan B Y', 'Initials': 'BBY', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}]",Journal of advanced nursing,['10.1111/jan.14164']
3788,16641168,"Gemcitabine plus CI-994 offers no advantage over gemcitabine alone in the treatment of patients with advanced pancreatic cancer: results of a phase II randomized, double-blind, placebo-controlled, multicenter study.","BACKGROUND
CI-994, an oral histone deacetylase inhibitor, has antineoplastic activity and synergism with gemcitabine preclinically. This randomized phase II trial explored whether CI-994 plus gemcitabine improves overall survival, objective response, duration of response, time to treatment failure and change in quality of life (QoL) or pain compared with gemcitabine alone.
PATIENTS AND METHODS
A total of 174 patients received CG (CI-994 6 mg/m(2)/day days 1-21 plus gemcitabine 1000 mg/m(2) days 1, 8 and 15 each 28-day cycle) or PG (placebo plus gemcitabine 1000 mg/m(2) days 1, 8 and 15 of each 28-day cycle days 1-21).
RESULTS
Median survival was 194 days (CG) versus 214 days (PG) (P = 0.908). The objective response rate with CG was 12% versus 14% with PG when investigator-assessed and 1% versus 6%, respectively, when assessed centrally. Time to treatment failure did not differ between the two arms (P = 0.304). QoL scores at 2 months were worse with CG than with PG. Pain response rates were similar between the two groups. There was an increased incidence of neutropenia and thrombocytopenia with CG.
CONCLUSIONS
Adding CI-994 to gemcitabine in advanced pancreatic carcinoma does not improve overall survival, response rate or time to progression; CG produced decreased QoL and increased hematological toxicity and appears inferior to single-agent gemcitabine.",2006,"RESULTS
Median survival was 194 days (CG) versus 214 days (PG) (P = 0.908).","['patients with advanced pancreatic cancer', '174 patients received', 'advanced pancreatic carcinoma']","['gemcitabine', 'CG (CI-994 6 mg/m(2)/day days 1-21 plus gemcitabine', 'CI-994 plus gemcitabine', 'placebo', 'gemcitabine alone', 'PG (placebo plus gemcitabine', 'Gemcitabine plus CI-994']","['objective response rate with CG', 'hematological toxicity', 'overall survival, response rate', 'Time to treatment failure', 'Median survival', 'QoL scores', 'Pain response rates', 'neutropenia and thrombocytopenia', 'overall survival, objective response, duration of response, time to treatment failure and change in quality of life (QoL) or pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0235974', 'cui_str': 'Pancreatic Acinar Carcinoma'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0217595', 'cui_str': 'CI 994'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}]",174.0,0.387619,"RESULTS
Median survival was 194 days (CG) versus 214 days (PG) (P = 0.908).","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'US Oncology Research, Inc., Houston, TX 75702, USA. Donald.Richards@USOncology.com'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Boehm', 'Affiliation': ''}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Waterhouse', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Wagener', 'Affiliation': ''}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Krishnamurthi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rosemurgy', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Grove', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Macdonald', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gulyas', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Dasse', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,[]
3789,32003278,"Comparison of the pharmacological properties of 0.375% bupivacaine with epinephrine, 0.5% ropivacaine and a mixture of bupivacaine with epinephrine and lignocaine - a randomized prospective study.","One of the methods of anesthesia for orthopedic and plastic procedures for the upper limb is the brachial plexus block. The aim of the study was to compare the pharmacodynamic and pharmacokinetic properties of three commonly used local anesthetic solutions used for axillary brachial plexus blockade. Sixty patients scheduled for surgery of the upper limb were enrolled for the study. 3 different local anesthetic solutions: 0.375% bupivacaine with epinephrine (group B), 0.5% ropivacaine (group R) and a mixture of 0.5% bupivacaine with epinephrine and 2% lignocaine in a 1:1 ratio (group BL) were used to anesthesia. The study assessed the delay time of sensory and motor blockade and the duration of sensory and motor anesthesia of the operated limb. There were no significant differences in the onset of sensory block between the study groups. In the BL group, the onset of the motor block was significantly shorter than in group B and group R. The duration of the sensory and motor blockade was significantly longer in group B and group R than in the group BL. The solution of 0.375% bupivacaine with epinephrine and 0.5% ropivacaine used for axillary brachial plexus anesthesia provide the same level of the block. Addition of short acting local anesthetic - lignocaine to long acting bupivacaine decreases the time to onset of motor blockade, but also shortens the duration of the sensory and motor blockade in the post-operative period, compared to long acting local anesthetics of higher potency: bupivacaine with epinephrine or ropivacaine.",2020,"Addition of short acting local anesthetic - lignocaine to long acting bupivacaine decreases the time to onset of motor blockade, but also shortens the duration of the sensory and motor blockade in the post-operative period, compared to long acting local anesthetics of higher potency: bupivacaine with epinephrine or ropivacaine.",['Sixty patients scheduled for surgery of the upper limb were enrolled for the study'],"['bupivacaine with epinephrine and 2% lignocaine', 'bupivacaine', 'lignocaine', 'bupivacaine with epinephrine', 'ropivacaine', 'bupivacaine with epinephrine and lignocaine', 'bupivacaine with epinephrine, 0.5% ropivacaine', 'epinephrine']","['onset of sensory block', 'delay time of sensory and motor blockade and the duration of sensory and motor anesthesia of the operated limb', 'duration of the sensory and motor blockade', 'onset of the motor block']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0522486', 'cui_str': 'Delay time (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]",60.0,0.040172,"Addition of short acting local anesthetic - lignocaine to long acting bupivacaine decreases the time to onset of motor blockade, but also shortens the duration of the sensory and motor blockade in the post-operative period, compared to long acting local anesthetics of higher potency: bupivacaine with epinephrine or ropivacaine.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Bobik', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Juliusz', 'Initials': 'J', 'LastName': 'Kosel', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Świrydo', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Tałałaj', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University Teaching Hospital of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Czaban', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University Teaching Hospital of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Radziwon', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University Teaching Hospital of Bialystok, Bialystok, Poland.'}]",Journal of plastic surgery and hand surgery,['10.1080/2000656X.2020.1720999']
3790,31898939,Clinical Study of Standard- vs Reduced-Dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Kidney Transplantation: A Prospective Randomized Trial.,"BACKGROUND
The lowering of calcineurin inhibitor exposure is possibly considered as the proper strategy to prevent calcineurin inhibitor-induced nephrotoxicity in kidney transplant. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) vs standard-dose tacrolimus with reduced-dose MMF.
METHODS
A prospective, multicenter, open-label, randomized, and parallel-group clinical trial was conducted at 4 transplant centers in Korea. A total sample size was 108, and eligible patients were randomly assigned in a 1:1 ratio to either reduced-dose tacrolimus with standard-dose MMF (the study group) or standard-dose tacrolimus with reduced-dose MMF (the control group) for 6 months in de novo kidney transplant recipients. Graft function, the incidence of efficacy failure, and adverse events were compared.
RESULTS
The mean estimated glomerular filtration rate at 6 months post-transplantation was 69.83 ± 16.68 mL/min/1.73 m 2 in the study group and 69.92 ± 17.55 mL/min/1.73 m 2 in the control group (P > .05). The overall incidence of biopsy-proven acute rejection was 3.64% (n = 2) in the study group, compared to 3.77% (n = 2) in the control group (P > .05). There was no graft loss, death, or loss of follow-up in either group.
CONCLUSION
In conclusion, the results suggest that tacrolimus minimization with standard-dose MMF provides adequate immunosuppression with proper renal function and similar rate of incidence of acute rejection compared with the regimen including standard-dose tacrolimus with reduced-dose MMF.",2020,"The overall incidence of biopsy-proven acute rejection was 3.64% (n = 2) in the study group, compared to 3.77% (n = 2) in the control group (P > .05).","['De Novo Kidney Transplantation', '4 transplant centers in Korea', 'A total sample size was 108, and eligible patients']","['Tacrolimus', 'tacrolimus with standard-dose mycophenolate mofetil (MMF) vs standard-dose tacrolimus', 'Generic Mycophenolate Mofetil', 'tacrolimus with standard-dose MMF (the study group) or standard-dose tacrolimus with reduced-dose MMF']","['efficacy and tolerability', 'mean estimated glomerular filtration rate', 'acute rejection', 'graft loss, death, or loss of follow', 'Graft function, the incidence of efficacy failure, and adverse events', 'overall incidence of biopsy-proven acute rejection']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]",,0.0926005,"The overall incidence of biopsy-proven acute rejection was 3.64% (n = 2) in the study group, compared to 3.77% (n = 2) in the control group (P > .05).","[{'ForeName': 'Jun Bae', 'Initials': 'JB', 'LastName': 'Bang', 'Affiliation': 'Department of Surgery, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Chang-Kwon', 'Initials': 'CK', 'LastName': 'Oh', 'Affiliation': 'Department of Surgery, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Man Ki', 'Initials': 'MK', 'LastName': 'Ju', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Joo', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hee Chul', 'Initials': 'HC', 'LastName': 'Yu', 'Affiliation': 'Department of Surgery, Jeonbuk National University College of Medicine, Jeonju, Korea.'}, {'ForeName': 'Su Hyung', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Ajou University School of Medicine, Suwon, Korea. Electronic address: dltngudgs@aumc.ac.kr.'}]",Transplantation proceedings,['10.1016/j.transproceed.2019.11.029']
3791,31989065,Dissecting the Contemporary Clerkship: Theory-based Educational Trial of Videos Versus Lectures in Medical Student Education.,"Background
Despite increasing use of the flipped classroom (FC) technique in undergraduate medical education, the benefit in learning outcomes over lectures is inconsistent. Best practices in preclass video design principles are rarely used, and it is unclear if videos can replace lectures in contemporary medical education.
Methods
We conducted a prospective quasi-experimental controlled educational study comparing theory-based videos to traditional lectures in a medical student curriculum. Medical students enrolled in an emergency medicine clerkship were randomly assigned to either a lecture group (LG) or a video group (VG). The slide content was identical, and the videos aligned with cognitive load theory-based multimedia design principles. Students underwent baseline (pretest), week 1 (posttest), and end-of-rotation (retention) written knowledge tests and an observed structured clinical examination (OSCE) assessment. We compared scores between both groups and surveyed student attitudes and satisfaction with respect to the two learning methods.
Results
There were 104 students who participated in OSCE assessments (49 LG, 55 VG) and 101 students who participated in knowledge tests (48 LG, 53 VG). The difference in OSCE scores was statistically significant 1.29 (95% confidence interval = 0.23 to 2.35, t(102) = 2.43, p = 0.017), but the actual score difference was small from an educational standpoint (12.61 for LG, 11.32 for VG). All three knowledge test scores for both groups were not significantly different.
Conclusions
Videos based on cognitive load theory produced similar results and could replace traditional lectures for medical students. Educators contemplating a FC approach should devote their valuable classroom time to active learning methods.",2020,"The difference in OSCE scores was statistically significant 1.29 (95% confidence interval = 0.23 to 2.35, t(102) = 2.43, p = 0.017), but the actual score difference was small from an educational standpoint (12.61 for LG, 11.32 for VG).","['104 students who participated in OSCE assessments (49 LG, 55 VG) and 101 students who participated in knowledge tests (48 LG, 53 VG', 'Medical students enrolled in an emergency medicine clerkship']","['flipped classroom (FC) technique', 'Contemporary Clerkship', 'lecture group (LG) or a video group (VG', 'theory-based videos to traditional lectures']",['OSCE scores'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}]","[{'cui': 'C0540654', 'cui_str': 'FLICE-Inhibitory Protein'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",104.0,0.0319496,"The difference in OSCE scores was statistically significant 1.29 (95% confidence interval = 0.23 to 2.35, t(102) = 2.43, p = 0.017), but the actual score difference was small from an educational standpoint (12.61 for LG, 11.32 for VG).","[{'ForeName': 'Stella H M', 'Initials': 'SHM', 'LastName': 'Yiu', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'Alena M', 'Initials': 'AM', 'LastName': 'Spacek', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Pageau', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'Michael Y C', 'Initials': 'MYC', 'LastName': 'Woo', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Curtis Lee', 'Affiliation': 'University of Newcastle Callaghan New South Wales Australia.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Frank', 'Affiliation': 'Royal College of Physicians and Surgeons of Canada Ottawa Ontario Canada.'}]",AEM education and training,['10.1002/aet2.10370']
3792,31836545,Beyond the bladder: poor sleep in women with overactive bladder syndrome.,"BACKGROUND
Nocturnal bladder symptoms and sleep disruption commonly coexist in middle-aged and older women. Although sleep disruption is often attributed to nocturnal bladder symptoms in women with overactive bladder syndrome, nonbladder factors also may influence sleep in this population. Many women with overactive bladder are eager to identify nonpharmacologic strategies for both bladder symptoms and sleep disruption, given the potential adverse effects of sedative and anticholinergic bladder medications in this population.
OBJECTIVES
To provide greater insight into the complex relationship between nighttime overactive bladder symptoms and sleep disruption, and to evaluate the effects of a guided slow-paced respiration intervention on sleep outcomes in women with overactive bladder.
STUDY DESIGN
We conducted an ancillary study within a randomized trial of slow-paced respiration in women with overactive bladder symptoms. Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence were randomized to use either a portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing (N=82). At baseline and after 12 weeks, bladder symptoms were assessed by voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality was determined by a Pittsburgh Sleep Quality Index global score >5.
RESULTS
Of the 161 women randomized, 31% reported at least twice-nightly nocturia, 26% nocturnal incontinence, and 70% poor sleep quality at baseline. Of the 123 reporting any nighttime awakenings, 89% averaged 1 or more nighttime awakenings, and 83% attributed at least half of awakenings to using the bathroom. Self-reported wake time after sleep onset increased with increasing frequency of nocturnal bladder symptoms (P=.01 for linear trend). However, even among women without nocturia, average sleep quality was poor (Pittsburg Sleep Quality Index global score mean of 7.3; 95% confidence interval, 6.0-8.6). Over 12 weeks, women assigned to slow-paced respiration (N=79) experienced modest improvements in mean nocturnal voiding frequency (0.4 fewer voids/night), sleep quality (1.1 point score decrease), and sleep disruption (1.5% decreased wake time after sleep onset). However, similar improvements were detected in the music control group (N=81), without significant between-group differences.
CONCLUSIONS
Many women with overactive bladder syndrome experience disrupted sleep, but not all nocturnal awakenings are attributable to bladder symptoms, and average sleep quality tends to be poor even in women without nocturia. Findings suggest that clinicians should not assume that poor sleep in women with overactive bladder syndrome is primarily caused by nocturnal bladder symptoms. Guided slow-paced respiration was associated with modest improvements in nocturia frequency and sleep quality in this trial, but the results do not support clinician recommendation to use this technique over other behavioral relaxation techniques for improving sleep.",2020,"However, similar improvements were detected in the music control group (N=81), without significant between-group differences.
","['women with overactive bladder', 'middle-aged and older women', 'Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence', 'women with overactive bladder syndrome', '161 women randomized', 'women with overactive bladder symptoms']","['slow-paced respiration', 'Guided slow-paced respiration', 'portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing', 'guided slow-paced respiration intervention']","['mean nocturnal voiding frequency', 'sleep outcomes', 'average sleep quality', 'nighttime awakenings', 'bladder symptoms', 'nocturia frequency and sleep quality', 'sleep quality', 'nocturnal bladder symptoms', 'voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality', 'Pittsburgh Sleep Quality Index global score >5', 'sleep disruption']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}]",161.0,0.110217,"However, similar improvements were detected in the music control group (N=81), without significant between-group differences.
","[{'ForeName': 'Marissa B', 'Initials': 'MB', 'LastName': 'Savoie', 'Affiliation': 'School of Medicine, University of California San Francisco, CA. Electronic address: marissa.savoie@ucsf.edu.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Lee', 'Affiliation': 'Department of Family Health Care Nursing, University of California San Francisco, CA.'}, {'ForeName': 'Leslee L', 'Initials': 'LL', 'LastName': 'Subak', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University, Stanford, CA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, University of California San Francisco, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schembri', 'Affiliation': 'Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California San Francisco, CA.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Fung', 'Affiliation': 'Department of Medicine, University of California at Los Angeles, CA; VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Grady', 'Affiliation': 'Department of Medicine, University of California San Francisco, CA.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, University of California San Francisco, CA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.005']
3793,31857535,What Happens to Swallowing Muscles after Stroke?: A Prospective Randomized Controlled Electrophysiological Study.,"Background
Stroke is the most frequent reason of neurological dysphagia Electrophysiological studies can be used to evaluate oral, pharyngeal and initial phase of esophageal phase.
Aims
This study aims to noninvasively evaluate mastication, mimic, and tongue muscles of stroke patients, which play an important role in the oral phase of swallowing process and compare them with healthy individuals.
Setting and Design
This study was conducted at the Physical Medicine and Rehabilitation Clinic of our hospital between January 2014 and December 2016.
Materials and Methods
Fifty-one patients who were admitted to our clinic with stroke and 51 healthy individuals were evaluated for the study. Demographic features of individuals were recorded. The swallowing intervals and motor action potentials (MAPs) of trigeminal, facial and hypoglossal nerves were measured. After four weeks of treatment schedule, patients were re-evaluated.
Statistical Analysis
The Wilcoxon Signed Rank test, the Mann-Whitney U test and Fisher exact test were used in this study.
Results
The all swallowing intervals were found prolonged compared to the healthy controls (P < 0.05). The MAPs of the masseter, orbicularis oculi, and intrinsic tongue muscles were significantly lower in patient group (P < 0.05). After treatment, we found significant improvement for all parameters in patient group, but the swallowing intervals were still significantly prolonged, and MAPs of these muscles were still lower (P < 0.05).
Conclusion
Although swallowing is examined as different phases, the process is complicated and should be evaluated totally. In post-stroke dysphagia, oral phase of swallowing process is as important as phayngeal phase and perioral, mastication, and tongue muscles are influenced even in an early period as a month.",2019,"The MAPs of the masseter, orbicularis oculi, and intrinsic tongue muscles were significantly lower in patient group (P < 0.05).","['Physical Medicine and Rehabilitation Clinic of our hospital between January 2014 and December 2016', 'Materials and Methods\n\n\nFifty-one patients who were admitted to our clinic with stroke and 51 healthy individuals', 'healthy individuals', 'stroke patients']",[],"['swallowing intervals and motor action potentials (MAPs) of trigeminal, facial and hypoglossal nerves', 'MAPs of the masseter, orbicularis oculi, and intrinsic tongue muscles', 'swallowing intervals']","[{'cui': 'C0031813', 'cui_str': 'Physiatrics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",[],"[{'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}, {'cui': 'C0020614', 'cui_str': 'Cranial Nerve XII'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",51.0,0.0154373,"The MAPs of the masseter, orbicularis oculi, and intrinsic tongue muscles were significantly lower in patient group (P < 0.05).","[{'ForeName': 'Ebru Karaca', 'Initials': 'EK', 'LastName': 'Umay', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Ankara Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Yilmaz', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Ankara Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Gundogdu', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Ankara Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Ozturk', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Ankara Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Gurcay', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Ankara Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Karaahmet', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Ankara Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Guleser', 'Initials': 'G', 'LastName': 'Saylam', 'Affiliation': 'Otolaryngology-Head and Neck Surgery Department, Ankara Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Tijen', 'Initials': 'T', 'LastName': 'Ceylan', 'Affiliation': 'Otolaryngology-Head and Neck Surgery Department, Ankara Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Aytul', 'Initials': 'A', 'LastName': 'Cakci', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Ankara Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}]",Neurology India,['10.4103/0028-3886.273645']
3794,31345626,Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial.,"BACKGROUND
The PORTEC-3 trial investigated the benefit of combined adjuvant chemotherapy and radiotherapy versus pelvic radiotherapy alone for women with high-risk endometrial cancer. We updated the analysis to investigate patterns of recurrence and did a post-hoc survival analysis.
METHODS
In the multicentre randomised phase 3 PORTEC-3 trial, women with high-risk endometrial cancer were eligible if they had International Federation of Gynaecology and Obstetrics (FIGO) 2009 stage I, endometrioid grade 3 cancer with deep myometrial invasion or lymphovascular space invasion, or both; stage II or III disease; or stage I-III disease with serous or clear cell histology; were aged 18 years and older; and had a WHO performance status of 0-2. Participants were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or chemoradiotherapy (two cycles of cisplatin 50 mg/m 2 given intravenously during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m 2 given intravenously), by use of a biased coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage, and histological type. The co-primary endpoints were overall survival and failure-free survival. Secondary endpoints of vaginal, pelvic, and distant recurrence were analysed according to the first site of recurrence. Survival endpoints were analysed by intention-to-treat, and adjusted for stratification factors. Competing risk methods were used for failure-free survival and recurrence. We did a post-hoc analysis to analyse patterns of recurrence with 1 additional year of follow-up. The study was closed on Dec 20, 2013; follow-up is ongoing. This study is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138.
FINDINGS
Between Nov 23, 2006, and Dec 20, 2013, 686 women were enrolled, of whom 660 were eligible and evaluable (330 in the chemoradiotherapy group, and 330 in the radiotherapy-alone group). At a median follow-up of 72·6 months (IQR 59·9-85·6), 5-year overall survival was 81·4% (95% CI 77·2-85·8) with chemoradiotherapy versus 76·1% (71·6-80·9) with radiotherapy alone (adjusted hazard ratio [HR] 0·70 [95% CI 0·51-0·97], p=0·034), and 5-year failure-free survival was 76·5% (95% CI 71·5-80·7) versus 69·1% (63·8-73·8; HR 0·70 [0·52-0·94], p=0·016). Distant metastases were the first site of recurrence in most patients with a relapse, occurring in 78 of 330 women (5-year probability 21·4%; 95% CI 17·3-26·3) in the chemoradiotherapy group versus 98 of 330 (5-year probability 29·1%; 24·4-34·3) in the radiotherapy-alone group (HR 0·74 [95% CI 0·55-0·99]; p=0·047). Isolated vaginal recurrence was the first site of recurrence in one patient (0·3%; 95% CI 0·0-2·1) in both groups (HR 0·99 [95% CI 0·06-15·90]; p=0·99), and isolated pelvic recurrence was the first site of recurrence in three women (0·9% [95% CI 0·3-2·8]) in the chemoradiotherapy group versus four (0·9% [95% CI 0·3-2·8]) in the radiotherapy-alone group (HR 0·75 [95% CI 0·17-3·33]; p=0·71). At 5 years, only one grade 4 adverse event (ileus or obstruction) was reported (in the chemoradiotherapy group). At 5 years, reported grade 3 adverse events did not differ significantly between the two groups, occurring in 16 (8%) of 201 women in the chemoradiotherapy group versus ten (5%) of 187 in the radiotherapy-alone group (p=0·24). The most common grade 3 adverse event was hypertension (in four [2%] women in both groups). At 5 years, grade 2 or worse adverse events were reported in 76 (38%) of 201 women in the chemoradiotherapy group versus 43 (23%) of 187 in the radiotherapy-alone group (p=0·002). Sensory neuropathy persisted more often after chemoradiotherapy than after radiotherapy alone, with 5-year rates of grade 2 or worse neuropathy of 6% (13 of 201 women) versus 0% (0 of 187). No treatment-related deaths were reported.
INTERPRETATION
This updated analysis shows significantly improved overall survival and failure-free survival with chemoradiotherapy versus radiotherapy alone. This treatment schedule should be discussed and recommended, especially for women with stage III or serous cancers, or both, as part of shared decision making between doctors and patients. Follow-up is ongoing to evaluate long-term survival.
FUNDING
Dutch Cancer Society, Cancer Research UK, National Health and Medical Research Council, Project Grant, Cancer Australia Grant, Italian Medicines Agency, and the Canadian Cancer Society Research Institute.",2019,"At 5 years, only one grade 4 adverse event (ileus or obstruction) was reported (in the chemoradiotherapy group).","['2009 stage', 'women with high-risk endometrial cancer (PORTEC-3', 'I, endometrioid grade 3 cancer with deep myometrial invasion or lymphovascular space invasion, or both; stage II or III disease; or stage I-III disease with serous or clear cell histology; were aged 18 years and older; and had a WHO performance status of 0-2', '0·70', 'women with high-risk endometrial cancer', 'women with stage III or serous cancers', 'Between Nov 23, 2006, and Dec 20, 2013, 686 women were enrolled, of whom 660 were eligible and evaluable (330 in the chemoradiotherapy group, and 330 in the radiotherapy-alone group', 'women with high-risk endometrial cancer were eligible if they had International Federation of Gynaecology and Obstetrics (FIGO']","['radiotherapy-alone group (HR 0·75', 'combined adjuvant chemotherapy and radiotherapy versus pelvic radiotherapy alone', 'Adjuvant chemoradiotherapy versus radiotherapy alone', 'chemoradiotherapy versus radiotherapy', 'radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or chemoradiotherapy (two cycles of cisplatin 50 mg/m 2 given intravenously during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel', 'radiotherapy', 'chemoradiotherapy']","['grade 2 or worse adverse events', '5-year rates of grade 2 or worse neuropathy', 'vaginal, pelvic, and distant recurrence', 'Isolated vaginal recurrence', 'grade 3 adverse events', 'overall survival and failure-free survival', 'Sensory neuropathy', '5-year overall survival', 'grade 4 adverse event (ileus or obstruction', 'Survival endpoints', '5-year failure-free survival', 'isolated pelvic recurrence']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C4081040', 'cui_str': 'Cisplatin 50 MG [Platinol]'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",686.0,0.472097,"At 5 years, only one grade 4 adverse event (ileus or obstruction) was reported (in the chemoradiotherapy group).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'de Boer', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands. Electronic address: s.m.de_boer.onco@lumc.nl.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Powell', 'Affiliation': 'Department of Clinical Oncology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Dionyssios', 'Initials': 'D', 'LastName': 'Katsaros', 'Affiliation': 'Department of Surgical Sciences, Gynecologic Oncology, Città della Salute and S Anna Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'Canadian Cancer Trials Group, Department of Obstetrics and Gynaecology, University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Haie-Meder', 'Affiliation': 'Department of Radiotherapy, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Petronella B', 'Initials': 'PB', 'LastName': 'Ottevanger', 'Affiliation': 'Department of Medical Oncology, Radboudumc, Nijmegen, Netherlands.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Cancer Research UK, London, UK; UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Pearly', 'Initials': 'P', 'LastName': 'Khaw', 'Affiliation': 'Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Romerai', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Division of Radiation Oncology, ASST-Lecco, Ospedale AManzoni, Lecco, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fyles', 'Affiliation': 'Canadian Cancer Trials Group, Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Marie-Helene', 'Initials': 'MH', 'LastName': 'Baron', 'Affiliation': 'Department of Radiotherapy, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.'}, {'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Jürgenliemk-Schulz', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Netherlands.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Kitchener', 'Affiliation': 'Institute of Cancer Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Nijman', 'Affiliation': 'Department of Gynaecologic Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Pathology, Central Manchester Hospitals NHS Foundation Trust, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Gribaudo', 'Affiliation': 'Department of Oncology - Radiotherapy, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Provencher', 'Affiliation': 'Department of Gynaecologic Oncology, Hôpital Notre-Dame de Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Hanzen', 'Affiliation': 'Department of Radiation Oncology, Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Roy F', 'Initials': 'RF', 'LastName': 'Kruitwagen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, Netherlands; GROW - School for Oncology and Developmental Biology, Maastricht, Netherlands.'}, {'ForeName': 'Vincent T H B M', 'Initials': 'VTHBM', 'LastName': 'Smit', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Naveena', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Cellular Pathology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Viet', 'Initials': 'V', 'LastName': 'Do', 'Affiliation': 'Department of Radiation Oncology, Liverpool Cancer Therapy Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lissoni', 'Affiliation': 'Gynecologic Oncology Unit, Department of Obstetrics and Gynecology, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Remi A', 'Initials': 'RA', 'LastName': 'Nout', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feeney', 'Affiliation': 'Cancer Research UK, London, UK; UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Verhoeven-Adema', 'Affiliation': 'Comprehensive Cancer Center Netherlands, Rotterdam, Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Carien L', 'Initials': 'CL', 'LastName': 'Creutzberg', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30395-X']
3795,31998013,Goal-directed fluid therapy using transoesophageal echocardiographic inferior venacaval index in patients with low left ventricular ejection fraction undergoing major cytoreductive surgery: A clinical trial.,"Background and Aims
This study aims to trans oesophageal echo cardiographically (TOE) measure inferior venacava diameter (IVCD) during inspiration and expiration in poor left ventricular ejection fraction (LVEF) patients undergoing cytoreductive oncosurgery, to ascertain if any correlation exists between, caval index (DeltaIVCD), and stroke volume variation (SVV), and to compare DeltaIVCD-guided versus SVV-guided fluid therapy.
Methods
In this prospective, parallel group, interventional study, seventy American Society of Anesthesiologists-III patients, aged 30-75 years, weighing 40-90 kg, with LVEF ≤40% undergoing cytoreductive surgery were included and randomised to group-D (DeltaIVCD-guided fluid therapy) and group-S (SVV-guided fluid therapy). Patients with oesophageal lesions were excluded. After standard endotracheal anaesthesia, arterial and internal jugular vein catheters were placed. A TOE probe was inserted in the interventional group-D. Quantification of IVCD respiratory variations was done. Heart rate (HR), arterial oxygen saturation (SPO 2 ), mean arterial pressure, end tidal carbondioxide (EtCO 2 ), central venous pressure, SVV, IVCD, and urine output (UO) were recorded every 30 min. Post-operative arterial blood gas analysis, lung-ultrasound, chest-radiograph, and serum creatinine were done.
Statistical Analysis
Pearson's correlation coefficient as measure of strength of linear relationship, calculation of regression equation, and unpaired t -test for normally distributed continuous variables were used.
Results
A positive correlation between DeltaIVCD and SVV (r = 0.751) was observed. A regression equation was obtained for SVV (SVV = [0.317 × DeltaIVCD] + 5.877). Serum lactate, estimated glomerular filtration rate, HR, and UO were within normal limits in group-D. There was no pulmonary oedema.
Conclusion
DeltaIVCD-guided intravenous fluid therapy is valuable in low LVEF patients where tight fluid control is essential and any fluid overload may precipitate cardiac failure.",2020,"Serum lactate, estimated glomerular filtration rate, HR, and UO were within normal limits in group-D.","['low LVEF patients', 'seventy American Society of Anesthesiologists-III patients, aged 30-75 years, weighing 40-90 kg, with LVEF ≤40% undergoing cytoreductive surgery', 'Patients with oesophageal lesions', 'patients with low left ventricular ejection fraction undergoing major cytoreductive surgery']","['Goal-directed fluid therapy', 'transoesophageal echocardiographic inferior venacaval index', 'standard endotracheal anaesthesia, arterial and internal jugular vein catheters', 'trans oesophageal echo cardiographically (TOE) measure inferior venacava diameter (IVCD', 'group-D (DeltaIVCD-guided fluid therapy) and group-S (SVV-guided fluid therapy']","['Post-operative arterial blood gas analysis, lung-ultrasound, chest-radiograph, and serum creatinine', 'caval index (DeltaIVCD), and stroke volume variation (SVV', 'Serum lactate, estimated glomerular filtration rate, HR, and UO', 'pulmonary oedema', 'Heart rate (HR), arterial oxygen saturation (SPO 2 ), mean arterial pressure, end tidal carbondioxide (EtCO 2 ), central venous pressure, SVV, IVCD, and urine output (UO']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C0522518', 'cui_str': 'Transesophageal approach (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002919', 'cui_str': 'Anesthesia, Intratracheal'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C3811844'}, {'cui': 'C0034063', 'cui_str': 'Wet Lung'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}]",70.0,0.118629,"Serum lactate, estimated glomerular filtration rate, HR, and UO were within normal limits in group-D.","[{'ForeName': 'Shagun Bhatia', 'Initials': 'SB', 'LastName': 'Shah', 'Affiliation': 'Department of Anaesthesia, Rajiv Gandhi Cancer Institute and Research Centre, Sector-5, Rohini, Delhi, India.'}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Bhargava', 'Affiliation': 'Department of Anaesthesia, Rajiv Gandhi Cancer Institute and Research Centre, Sector-5, Rohini, Delhi, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Hariharan', 'Affiliation': 'Dr. Ram Manohar Lohia Hospital and PGIMER, CHS, New Delhi, India.'}, {'ForeName': 'Chamound Rai', 'Initials': 'CR', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesia, Rajiv Gandhi Cancer Institute and Research Centre, Sector-5, Rohini, Delhi, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Anaesthesia, Rajiv Gandhi Cancer Institute and Research Centre, Sector-5, Rohini, Delhi, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesia, Rajiv Gandhi Cancer Institute and Research Centre, Sector-5, Rohini, Delhi, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_215_19']
3796,31992495,The Effect of Pregabalin on the Prevention of Succinylcholine-Induced Fasciculation and Myalgia.,"PURPOSE
This study evaluates the effect of pregabalin on fasciculation and myalgia after using succinylcholine.
DESIGN
This randomized double-blind prospective study was conducted among 100 patients aged 20 to 60 years old.
METHODS
Pregabalin (300 mg) and placebo (in capsule form) were placed in similar containers. The results were analyzed by SPSS 23 software, and statistical analysis consisted of χ 2 test and t test, and a P value less than .05 was considered significant.
FINDINGS
The mean pain score in the group receiving pregabalin was lower than the placebo group. According to the χ 2 test, there was a significant difference between the two groups in the frequency of fasciculation (P = .003). Mean fasciculation severity in the pregabalin group was lower than placebo group. According to t test, there was a significant difference in the mean fasciculation severity between the two groups (P = .002).
CONCLUSIONS
This study showed that 300 mg of pregabalin was effective in reducing postoperative fasciculation and myalgia in patients treated with succinylcholine.",2020,"According to the χ 2 test, there was a significant difference between the two groups in the frequency of fasciculation (P = .003).",['100 patients aged 20 to 60\xa0years old'],"['placebo', 'pregabalin', 'Pregabalin', 'succinylcholine']","['mean pain score', 'mean fasciculation severity', 'Mean fasciculation severity', 'frequency of fasciculation', 'fasciculation and myalgia', 'postoperative fasciculation and myalgia']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0015644', 'cui_str': 'Fasciculation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",100.0,0.117874,"According to the χ 2 test, there was a significant difference between the two groups in the frequency of fasciculation (P = .003).","[{'ForeName': 'Shahryar', 'Initials': 'S', 'LastName': 'Sane', 'Affiliation': 'Department of Anesthesiology, Urmia Imam Khomeini Hospital, Urmia University of Medical Science, Urmia, Iran.'}, {'ForeName': 'Mir Moussa', 'Initials': 'MM', 'LastName': 'Aghdashi', 'Affiliation': 'Department of Anesthesiology, Urmia Imam Khomeini Hospital, Urmia University of Medical Science, Urmia, Iran.'}, {'ForeName': 'Behzad Kazemi', 'Initials': 'BK', 'LastName': 'Haki', 'Affiliation': 'Department of Anesthesiology, Urmia Imam Khomeini Hospital, Urmia University of Medical Science, Urmia, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Gholamveisi', 'Affiliation': 'Department of Operating Room, Faculty of Nursing and Midwifery, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Rajabzadeh', 'Affiliation': 'Department of Medicine, Urmia University of Medical Science, Urmia, Iran.'}, {'ForeName': 'Parang', 'Initials': 'P', 'LastName': 'Golabi', 'Affiliation': 'Department of Anesthesiology, Mahabad Imam Khomeini Hospital, Urmia University of Medical Science, Mahabad, Iran. Electronic address: behzad_emt@yahoo.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.11.005']
3797,31994365,Long-term effect of oxycodone/naloxone on the management of postoperative pain after hysterectomy: a randomized prospective study.,"BACKGROUND
The analgesic efficacy of oxycodone prolonged-release (PR) combined with naloxone PR (OXN) in postoperative pain management is recognized, however, few studies have examined the efficacy of OXN on pain relief and bowel function following hysterectomy. This study compared the effect of OXN vs. standard treatment for post-operative pain management and bowel function following hysterectomy.
METHODS
This randomized prospective study included 83 women who underwent laparoscopic/laparotomic hysterectomy. General anesthesia was induced by propofol (1.5-2 mg/kg), fentanyl (50-100 μg) and rocuronium (0.6-1 mg/kg) and maintained with sevoflurane (MAC 0.8-1) and fentanyl (1-2 μg/kg). Intraoperative analgesia was performed with ketorolac (30 mg), paracetamol (1 g) and morphine (0.1 mg/kg). Postoperative analgesia in the control group (N.=41) included morphine (0.2-0.4 mg/kg/day), whereas the OXN (N.=42) group only received oxycodone (10 mg)/naloxone (5 mg) for the first 48 hours. As rescue analgesic, both groups received paracetamol (3 mg). Bowel Function Index (BFI) and pain numeric rating scales (NRS) were measured at day 0, 1, 2, 3, 5 and 7, whereas vital parameters, rescue medication and side effects were recorded for the first three days only.
RESULTS
Bowel function indices were significantly improved in OXN-treated patients at all time points compared to morphine-treated patients. Mean static pain NRS was significantly decreased at day 2 and day 3 and dynamic pain NRS at day 3 in the OXN group. Side effects, rescue analgesic and antiemetics were more frequent in the control group.
CONCLUSIONS
Improved pain control, bowel function and reduced side effects were observed with OXN compared to morphine in patients who underwent hysterectomy.",2020,"Improved pain control, bowel function and reduced side effects were observed with OXN compared to morphine in patients who underwent hysterectomy.","['83 women who underwent', 'post-operative pain after hysterectomy']","['morphine', 'laparoscopic/laparotomic hysterectomy', 'sevoflurane (MAC 0.8-1) and fentanyl', 'OXN', 'paracetamol', 'propofol', 'ketorolac', 'fentanyl', 'oxycodone/naloxone', 'oxycodone prolonged-release (PR) combined with naloxone PR (OXN', 'oxycodone (10mg)/naloxone', 'rocuronium']","['Side effects, rescue analgesic and antiemetics', 'Mean static pain NRS', 'vital parameters, rescue medication and side effects', 'pain relief and bowel function', 'Bowel function indices', 'Improved pain control, bowel function and reduced side effects', 'Bowel function index (BFI) and pain numeric rating scales (NRS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0222045'}]",83.0,0.0750278,"Improved pain control, bowel function and reduced side effects were observed with OXN compared to morphine in patients who underwent hysterectomy.","[{'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Iorno', 'Affiliation': ""Mario Tiengo Center of Pain Medicine, Maggiore Polyclinic Hospital, IRCCS Ca' Granda Foundation, Milan, Italy - vittorio.iorno@fastwebnet.it.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Landi', 'Affiliation': ""Mario Tiengo Center of Pain Medicine, Maggiore Polyclinic Hospital, IRCCS Ca' Granda Foundation, Milan, Italy.""}, {'ForeName': 'Giuliana A', 'Initials': 'GA', 'LastName': 'Porro', 'Affiliation': ""Mario Tiengo Center of Pain Medicine, Maggiore Polyclinic Hospital, IRCCS Ca' Granda Foundation, Milan, Italy.""}, {'ForeName': 'Colin G', 'Initials': 'CG', 'LastName': 'Egan', 'Affiliation': 'CE-Medical Writing, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Calderini', 'Affiliation': ""Mario Tiengo Center of Pain Medicine, Maggiore Polyclinic Hospital, IRCCS Ca' Granda Foundation, Milan, Italy.""}]",Minerva anestesiologica,['10.23736/S0375-9393.20.13745-3']
3798,31764266,Applying the Exploration Preparation Implementation Sustainment (EPIS) Framework to the Kigali Imbereheza Project for Rwandan Adolescents Living With HIV.,"BACKGROUND
Sub-Saharan African adolescents living with HIV face challenges to antiretroviral therapy (ART) adherence. Poor mental health drives nonadherence but can be improved with cognitive behavioral therapy (CBT). CBT delivered by peers may strengthen effects while building capacity for sustainment in low-income countries. This case study retrospectively applied the Exploration Preparation Implementation Sustainment framework to characterize the execution of the Kigali Imbereheza Project, a 2-arm individually randomized group controlled trial of Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV.
METHODS
YL (n = 14, 43% female, M = 22.71 years) had confirmed HIV and self-reported ART adherence >95%. Participants (n = 356, 51% female, M = 16.78 years) living with HIV were randomized to TI-CBTe or usual care. Two YLs co-led TI-CBTe sessions over 2 months for a total of 12 hours, while other YL observed and rated fidelity. Participants reported on YL competence. Additional data evaluated feasibility, acceptability, uptake, and fidelity.
RESULTS
In the Exploration phase, focus groups, stakeholder meetings, and individual interviews revealed strong consensus for delivering TI-CBT to reduce adolescent depression and trauma and improve ART adherence. In the Preparation phase, curriculum revisions were made, YLs were successfully trained, and a cascading supervision model was established. In the Implementation phase, YL delivered TI-CBTe with close monitoring and supervision. Findings revealed strong feasibility, acceptability, uptake, and fidelity, increasing the likelihood of Sustainment.
CONCLUSIONS
Exploration Preparation Implementation Sustainment can guide implementation planning and delivery and evaluate implementation outcomes.",2019,"Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV.
","['YL (n = 14, 43% female, M = 22.71 years) had confirmed HIV and self-reported ART adherence >95', 'Participants (n = 356, 51% female, M = 16.78 years) living with HIV', 'Rwandan Adolescents Living With HIV', 'adolescents living with HIV']","['cognitive behavioral therapy (CBT', 'Trauma-Informed Adherence-Enhanced CBT (TI-CBTe', 'TI-CBTe or usual care', 'CBT']","['adolescent depression and trauma and improve ART adherence', 'YL competence', 'feasibility, acceptability, uptake, and fidelity', 'strong feasibility, acceptability, uptake, and fidelity, increasing the likelihood of Sustainment']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0563725,"Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV.
","[{'ForeName': 'Geri R', 'Initials': 'GR', 'LastName': 'Donenberg', 'Affiliation': 'Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Mardge H', 'Initials': 'MH', 'LastName': 'Cohen', 'Affiliation': ""Women's Equity in Access to Care and Treatment (WE-ACTx), San Francisco, CA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ingabire', 'Affiliation': 'WE-ACTx for Hope Clinic (WFH) Kigali, Rwanda.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fabri', 'Affiliation': ""Women's Equity in Access to Care and Treatment (WE-ACTx), San Francisco, CA.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Emerson', 'Affiliation': 'Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Kendall', 'Affiliation': 'Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Remera', 'Affiliation': 'Institute for HIV Disease Prevention and Control, Rwandan Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Manzi', 'Affiliation': 'Department of Medicine, University Teaching Hospital of Kigali (CHUK), Kigali, Rwanda.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Nsanzimana', 'Affiliation': 'Institute for HIV Disease Prevention and Control, Rwandan Biomedical Center, Kigali, Rwanda.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002204']
3799,21804794,Analgesic properties of a dexmedetomidine infusion after uvulopalatopharyngoplasty in patients with obstructive sleep apnea.,"BACKGROUND
Dexmedetomidine is an alpha(2) -adrenergic agonist with sedative and analgesic properties. This study aimed to investigate if the use of a continuous dexmedetomidine infusion with i.v. morphine patient-controlled analgesia (PCA) could improve postoperative analgesia while reducing opioid consumption and opioid-related side effects.
METHODS
In this prospective randomized, double-blinded, controlled study, 39 patients with obstructive sleep apnea syndrome undergoing uvulopalatopharyngoplasty were assigned to two groups. Group D (dexmedetomidine group) received a loading dose of dexmedetomidine 1 μg.kg(-1) i.v., 30 minutes before the anticipated end of surgery, followed by infusion at 0.6 μg.kg(-1) h(-1) for 24 hours. Group P (placebo group) received a bolus and infusion of placebo. In both groups, postoperative pain was initially controlled by i.v. morphine titration and then PCA with morphine. Cumulative PCA morphine consumption, pain intensities, sedation scores, cardiovascular and respiratory variables and opioid-related adverse effects were recorded for 48 hours after operation.
RESULTS
Compared with placebo group, patients in the dexmedetomidine group required 52.7% less PCA morphine during the first 24 hours postoperatively, with significantly better visual analogue scale scores, less incidence of respiratory obstruction (5 vs. 12 patients, respectively; P = .037) and longer time to first analgesic request (21 (11) vs. 9 (4) minutes; P = .002). Fewer patients in group D experienced nausea and vomiting than those in group P (7 vs. 24 patients, respectively; P < .05).
CONCLUSION
Continuous dexmedetomidine infusion may be a useful analgesic adjuvant for patients susceptible to opioid-induced respiratory depression.",2011,"Compared with placebo group, patients in the dexmedetomidine group required 52.7% less PCA morphine during the first 24 hours postoperatively, with significantly better visual analogue scale scores, less incidence of respiratory obstruction (5 vs. 12 patients, respectively; P = .037) and longer time to first analgesic request (21 (11) vs. 9 (4) minutes; P = .002).","['patients with obstructive sleep apnea', '39 patients with obstructive sleep apnea syndrome undergoing uvulopalatopharyngoplasty', 'patients susceptible to opioid-induced respiratory depression']","['morphine', 'placebo', 'Group D (dexmedetomidine', 'Dexmedetomidine', 'Group P (placebo', 'morphine titration', 'dexmedetomidine infusion after uvulopalatopharyngoplasty', 'dexmedetomidine 1 μg.kg(-1) i.v', 'morphine patient-controlled analgesia (PCA', 'dexmedetomidine']","['nausea and vomiting', 'incidence of respiratory obstruction', 'PCA morphine', 'longer time to first analgesic request', 'Cumulative PCA morphine consumption, pain intensities, sedation scores, cardiovascular and respiratory variables and opioid-related adverse effects', 'postoperative pain', 'visual analogue scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C1535578', 'cui_str': 'Uvulopalatopharyngoplasty (procedure)'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1535578', 'cui_str': 'Uvulopalatopharyngoplasty (procedure)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",39.0,0.294084,"Compared with placebo group, patients in the dexmedetomidine group required 52.7% less PCA morphine during the first 24 hours postoperatively, with significantly better visual analogue scale scores, less incidence of respiratory obstruction (5 vs. 12 patients, respectively; P = .037) and longer time to first analgesic request (21 (11) vs. 9 (4) minutes; P = .002).","[{'ForeName': 'Waleed M', 'Initials': 'WM', 'LastName': 'Abdelmageed', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Ain-Shams University, Cairo, Egypt.'}, {'ForeName': 'Kaled M', 'Initials': 'KM', 'LastName': 'Elquesny', 'Affiliation': ''}, {'ForeName': 'Ramadn I', 'Initials': 'RI', 'LastName': 'Shabana', 'Affiliation': ''}, {'ForeName': 'Hossam M', 'Initials': 'HM', 'LastName': 'Abushama', 'Affiliation': ''}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Nassar', 'Affiliation': ''}]",Saudi journal of anaesthesia,['10.4103/1658-354X.82782']
3800,31998019,Comparison of injection pain in pediatric population; original versus generic rocuronium.,"Background
Rocuronium-induced injection pain causes withdrawal movements. These movements may cause accidental disruption of indwelling needles. Generic rocuronium contains low-acid concentration buffer solution compared with original rocuronium. In animal experiments, it has been suggested that the difference of the buffer solution may alleviate injection pain. The purpose of this study was to identify the difference of injection pain between original and generic rocuronium in pediatric population.
Material and Methods
Patients ranging in age from 1 to 15 years, American Society of Anesthesiologists physical status I or II, undergoing elective surgeries were randomly allocated to two groups; generic rocuronium group (Group R) and original rocuronium (Eslax®) group (Group E). Following anesthetic induction with oxygen, nitrous oxide, and sevoflurane, original or generic rocuronium (1 mg/kg) was administered via intravenous catheter. The difference of vital signs and withdrawal movement associated with rocuronium injection were evaluated.
Results
A total of 64 patients were included in the study. Three patients were excluded. Twenty-nine patients were assigned to Group E and 32 patients to Group R. There was no significant difference in mean arterial pressure and heart rate. No withdrawal movements were observed in both groups.
Conclusion
There was no significant difference in injection pain between original and generic rocuronium under inhalational induction.",2020,There was no significant difference in injection pain between original and generic rocuronium under inhalational induction.,"['pediatric population', 'Twenty-nine patients were assigned to Group E and 32 patients to Group R', 'I or II, undergoing elective surgeries', 'A total of 64 patients were included in the study', 'Material and Methods\n\n\nPatients ranging in age from 1 to 15 years, American Society of Anesthesiologists physical status']","['oxygen, nitrous oxide, and sevoflurane, original or generic rocuronium', 'Generic rocuronium', 'Rocuronium-induced injection pain', 'generic rocuronium group (Group R) and original rocuronium (Eslax®', 'rocuronium']","['withdrawal movements', 'mean arterial pressure and heart rate', 'injection pain', 'vital signs and withdrawal movement']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0441839', 'cui_str': 'Group E (qualifier value)'}, {'cui': 'C0441852', 'cui_str': 'Group R (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441852', 'cui_str': 'Group R (qualifier value)'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518766'}]",3.0,0.434003,There was no significant difference in injection pain between original and generic rocuronium under inhalational induction.,"[{'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Watanabe', 'Affiliation': ""Department of Anesthesiology, Aichi Children's Health and Medical Center, 426 Nana-Chome, Morioka-Cho, Obu-City, Aichi, Japan.""}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kako', 'Affiliation': ""Department of Anesthesiology, Aichi Children's Health and Medical Center, 426 Nana-Chome, Morioka-Cho, Obu-City, Aichi, Japan.""}, {'ForeName': 'Mitsunori', 'Initials': 'M', 'LastName': 'Miyazu', 'Affiliation': ""Department of Anesthesiology, Aichi Children's Health and Medical Center, 426 Nana-Chome, Morioka-Cho, Obu-City, Aichi, Japan.""}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_338_19']
3801,31998015,Efficacy of single-shot ultrasound-guided erector spinae plane block for postoperative analgesia after mastectomy: A randomized controlled study.,"Background
The aim of this study is to understand the effect of ultrasound (US) guided erector spinae plane block (ESPB) in improving the intraoperative and postoperative analgesia in patients undergoing mastectomies, decreasing the use of opioids and in reducing postoperative nausea and vomiting.
Methods
After local ethics committee approval, 100 patients were divided randomly into two groups. Group A with 50 patients received US guided ESPB with 30 ml of 0.25% of bupivacaine under US guidance. Group B with 50 patients received no block. Visual analogue scale (VAS) was used to assess pain postoperatively. All patients received 1 g intravenous intravenous paracetamol 8th hourly and morphine was used as rescue analgesia if VAS score is more than 4. Patients were monitored for VAS scores, postoperative nausea/ vomiting and total morphine consumption for a 24-hour period in a high dependency unit.
Results
Postoperative morphine consumption was found to be significantly less in patients who received US-guided ESPB compared to control group (0.12 mg ± 0.59 mg in ESPB group compared to 1.70 ± 2.29 mg which was statistically significant, p =0.000). Only 3 patients in ESP group received rescue analgesia in the form of morphine whereas 22 patients in the control group received morphine. There was no difference in PONV score in either groups. There were no complications like vascular puncture, pneumothorax, or respiratory depression in both groups.
Conclusion
US guided ESPB is quite effective in reducing perioperative pain in patients undergoing mastectomy. The trial was registered prospectively with CTRI with registration number: CTRI/2018/09/015668.",2020,"Results
Postoperative morphine consumption was found to be significantly less in patients who received US-guided ESPB compared to control group (0.12 mg ± 0.59 mg in ESPB group compared to 1.70 ± 2.29 mg which was statistically significant, p =0.000).","['100 patients', 'patients undergoing mastectomy', 'patients undergoing mastectomies', 'postoperative analgesia after mastectomy']","['single-shot ultrasound-guided erector spinae plane block', 'bupivacaine', 'morphine', 'ESPB', 'ESP', 'US guided ESPB', 'intravenous intravenous paracetamol', 'ultrasound (US) guided erector spinae plane block (ESPB']","['Postoperative morphine consumption', 'rescue analgesia', 'Visual analogue scale (VAS', 'VAS scores, postoperative nausea/ vomiting and total morphine consumption', 'perioperative pain', 'PONV score', 'complications like vascular puncture, pneumothorax, or respiratory depression']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory Perception'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}]",100.0,0.0851858,"Results
Postoperative morphine consumption was found to be significantly less in patients who received US-guided ESPB compared to control group (0.12 mg ± 0.59 mg in ESPB group compared to 1.70 ± 2.29 mg which was statistically significant, p =0.000).","[{'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Seelam', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Abhijit S', 'Initials': 'AS', 'LastName': 'Nair', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Asiel', 'Initials': 'A', 'LastName': 'Christopher', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Omkar', 'Initials': 'O', 'LastName': 'Upputuri', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Vibhavari', 'Initials': 'V', 'LastName': 'Naik', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Basanth Kumar', 'Initials': 'BK', 'LastName': 'Rayani', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, Telangana, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_260_19']
3802,31998022,Epidural administration of ropivacaine and its effects on the pharmacodynamics of rocuronium: Randomized controlled trial. Interaction between ropivacaine and rocuronium.,"Background
Potentiation of neuromuscular blocking agents by local anesthetics has been described in various clinical and experimental studies. This study assessed the influence of epidural ropivacaine on pharmacodynamic characteristics of rocuronium.
Design
This was a prospective randomized clinical trial at the women's hospital, an university tertiary hospital in Brazil. Sixty-two patients underwent elective abdominal surgeries requiring general anesthesia.
Intervention
Patients were distributed into two groups: Group 1 (general anesthesia and epidural anesthesia) and Group 2 (general anesthesia). In Group 1, 0.2% ropivacaine at a dose of 40 mg (20 ml) was associated with 2 mg (2 ml) of morphine in a single epidural injection. The following parameters were assessed: clinical duration (DC 25 ) and time for recovery of the train-of-four (TOF) 0.9 ratio (T4/T1 = 90%) after an initial 0.6 mg/kg dose of rocuronium. The primary outcomes were DC 25 and TOF 0.9 ratio (T4/T1 = 90%). Secondary outcomes were total propofol and remifentanil consumption.
Results
Values were presented as median and interquartile range. The results for DC 25 and TOF 0.9 of rocuronium were, respectively, 41.5 35.0-55.0 (25.0-63.0) in Group 1 and 44.0 37.0-51.0 (20.0-67.0) in Group 2 ( P = 0.88); 88.0 67.0-99.0 (43.0-137.0) in Group 1; and 80.0 71.0-86.0 (38.0-155.0) in Group 2 ( P = 0.83). There was no significant difference between the groups, in terms of pharmacodynamic characteristics of rocuronium. Propofol consumption did not show any difference between the groups. However, remifentanil consumption was significantly lower in Group 1 ( P < 0.01).
Conclusion
Epidural ropivacaine, in the dose studied, did not prolong the duration of rocuronium-induced neuromuscular blockade.
Trial Registry Number
ReBEC (ref: RBR-7cyp6t).",2020,"However, remifentanil consumption was significantly lower in Group 1 ( P < 0.01).
","['Sixty-two patients underwent elective abdominal surgeries requiring general anesthesia', ""women's hospital, an university tertiary hospital in Brazil"", 'Trial Registry Number\n\n\nReBEC (ref']","['ropivacaine and rocuronium', 'morphine', 'epidural ropivacaine', 'ropivacaine', 'Group 1 (general anesthesia and epidural anesthesia) and Group 2 (general anesthesia', 'rocuronium']","['clinical duration (DC 25 ) and time for recovery of the train-of-four (TOF) 0.9 ratio', 'Propofol consumption', 'remifentanil consumption', 'pharmacodynamic characteristics of rocuronium', 'total propofol and remifentanil consumption', 'DC 25 and TOF 0.9 ratio']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1510665', 'cui_str': 'H